APPROVED

DRUG

PRODUCTS

WITH

THERAPEUTIC

EQUIVALENCE

EVALUATIONS

36th EDITION

THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER

SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF GENERIC DRUGS

OFFICE OF GENERIC DRUG POLICY

2016

APPROVED DRUG PRODUCTS

with

THERAPEUTIC EQUIVALENCE EVALUATIONS

The products in this list have been approved under section 505 of the
Federal Food, Drug, and Cosmetic Act. This volume is current through
December 31, 2015.

36th EDITION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF GENERIC DRUGS

OFFICE OF GENERIC DRUG POLICY

2016

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

APPROVED DRUG PRODUCTS

with

Therapeutic Equivalence Evaluations

CONTENTS
PAGE

PREFACE TO THIRTY SIXTH EDITION...................iv

1 INTRODUCTION................................................................................................................ vi

1.1
Content and Exclusion ................................................................................................... vi

1.2
Therapeutic Equivalence-Related Terms ....................................................................... vi

1.3
Further Guidance on Bioequivalence ............................................................................. ix

1.4
Reference Listed Drug ................................................................................................... ix

1.5
General Policies and Legal Status .................................................................................. x

1.6
Practitioner/User Responsibilities ................................................................................... x

1.7
Therapeutic Equivalence Evaluations Codes .................................................................xii

1.8
Description of Certain Special Situations ...................................................................... xx

1.9
Therapeutic Equivalence Code Change for a Drug Entity ............................................ xxii

1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product ..................... xxii

1.11 Discontinued Section .................................................................................................. xxiii

1.12 Changes to the Orange Book...................................................................................... xxiii

1.13 Availability of the Edition .............................................................................................xxiv

2
2.1
2.2
2.3

HOW TO USE THE DRUG PRODUCTS LISTS ..............................................................2-1

Key Sections for Using the Drug Product Lists ........2-1

Drug Product Illustration ......2-3

Therapeutic Equivalence Evaluations Illustration ....2-4

DRUG PRODUCT LISTS

Prescription Drug Product List .....3-1

OTC Drug Product List ..4-1

Drug Products with Approval under Section 505 of the FD&C Act Administered

by the Center for Biologics Evaluation and Research List ........5-1

Discontinued Drug Product List .......6-1

Orphan Products Designations and Approvals List .....7-1

Drug Products Which Must Demonstrate in vivo Bioavailability

Only if Product Fails to Achieve Adequate Dissolution ....8-1

APPENDICES
A. Product Name Index .......A-1
B. Product Name Index Listed by Applicant .....B-1

C. Uniform Terms .........C-1

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM .............AD1

A. Patent and Exclusivity Lists .......ADA1

B. Patent and Exclusivity Terms ........ADB1

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

APPROVED DRUG PRODUCTS

with

Therapeutic Equivalence Evaluations

PREFACE TO THIRTY SIXTH EDITION

The publication, Approved Drug Products with Therapeutic Equivalence
Evaluations (the List, commonly known as the Orange Book), identifies drug
products approved on the basis of safety and effectiveness by the Food and
Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act). Drugs on the market approved only on the basis of safety (covered
by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g.,
Donnatal Tablets and Librax Capsules] or pre-1938 drugs [e.g.,
Phenobarbital Tablets]) are not included in this publication. The main
criterion for the inclusion of any product is that the product is the subject
of an application with an effective approval that has not been withdrawn for
safety or efficacy reasons. Inclusion of products on the List is independent
of any current regulatory action through administrative or judicial means
against a drug product. In addition, the List contains therapeutic
equivalence evaluations for approved multisource prescription drug products.
These evaluations have been prepared to serve as public information and
advice to state health agencies, prescribers, and pharmacists to promote
public education in the area of drug product selection and to foster
containment of health care costs. Therapeutic equivalence evaluations in
this publication are not official FDA actions affecting the legal status of
products under the FD&C Act.
Background of the Publication. To contain drug costs, virtually every
state has adopted laws and/or regulations that encourage the substitution of
drug products. These state laws generally require either that substitution
be limited to drugs on a specific list (the positive formulary approach) or
that it be permitted for all drugs except those prohibited by a particular
list (the negative formulary approach). Because of the number of requests in
the late 1970s for FDA assistance in preparing both positive and negative
formularies, it became apparent that FDA could not serve the needs of each
state on an individual basis. The Agency also recognized that providing a
single list based on common criteria would be preferable to evaluating drug
products on the basis of differing definitions and criteria in various state
laws. As a result, on May 31, 1978, the Commissioner of the Food and Drug
Administration sent a letter to officials of each state stating FDA's intent
to provide a list of all prescription drug products that are approved by FDA
for safety and effectiveness, along with therapeutic equivalence
determinations for multisource prescription products.
The List was distributed as a proposal in January l979. It included only
currently marketed prescription drug products approved by FDA through new
drug applications (NDAs) and abbreviated new drug applications (ANDAs) under
the provisions of Section 505 of the FD&C Act.
The therapeutic equivalence evaluations in the List reflect FDA's
application of specific criteria to the multisource prescription drug
products on the List approved under Section 505 of the FD&C Act. These
evaluations are presented in the form of code letters that indicate the basis

iv

for the evaluation made.

Introduction.

An explanation of the code appears in the

A complete discussion of the background and basis of FDA's therapeutic

equivalence evaluation policy was published in the Federal Register on
January 12, 1979 (44 FR 2932). The final rule, which includes FDA's
responses to the public comments on the proposal, was published in the
Federal Register on October 31, 1980 (45 FR 72582). The first publication,
October 1980, of the final version of the List incorporated appropriate
corrections and additions. Each subsequent edition has included the new
approvals and made appropriate changes in data.
On September 24, 1984, the President signed into law the Drug Price
Competition and Patent Term Restoration Act of 1984 (1984 Amendments). The
1984 Amendments require that FDA, among other things, make publicly available
a list of approved drug products with monthly supplements. The Approved Drug
Products with Therapeutic Equivalence Evaluations publication and its monthly
Cumulative Supplements satisfy this requirement. The Addendum to this
publication identifies drugs that qualify under the 1984 Amendments for
periods of exclusivity (during which ANDAs or applications described in
Section 505(b)(2) of the FD&C Act for those drugs may not be submitted for a
specified period of time and, if allowed to be submitted, would be
tentatively approved) and provides patent information concerning the listed
drugs which also may delay the approval of ANDAs or Section 505(b)(2)
applications. The Addendum also provides additional information that may be
helpful to those submitting a new drug application to the Agency.
The Agency intends to use this publication to further its objective of
obtaining input and comment on the publication itself and related Agency
procedures. Therefore, if you have comments on how the publication can be
improved, please send them to the Director, Division of Legal & Regulatory
Support, Office of Generic Drugs, Center for Drug and Evaluation and
Research, 7620 Standish Place, Rockville, MD 20855-2773. Comments received
are publicly available to the extent allowable under the Freedom of
Information regulations.

1. INTRODUCTION

1.1 Content and Exclusion

The List is composed of four parts: (1) approved prescription drug
products with therapeutic equivalence evaluations; (2) approved
over-the-counter (OTC) drug products for those drugs that may not be marketed
without NDAs or ANDAs because they are not covered under existing OTC
monographs; (3) drug products with approval under Section 505 of the FD&C Act
administered by the Center for Biologics Evaluation and Research; and (4) a
cumulative list of approved products that have never been marketed, are for
exportation, are for military use, have been discontinued from marketing and
we have not determined that they were withdrawn for safety or effectiveness
reasons, or have had their approvals withdrawn for other than safety or
efficacy reasons subsequent to being discontinued from marketing. 1 This
publication also includes indices of prescription and OTC drug products by
trade or established name (if no trade name exists) and by applicant name
(holder of the approved application). All established names for active
ingredients generally conform to official compendial names or United States
Adopted Names (USAN) as described in (21 CFR 299.4(e)). The latter list
includes applicants names as abbreviated in this publication; in addition, a
list of uniform terms is provided in Appendix C.
An Addendum contains drug patent and exclusivity information for the
Prescription, OTC, Discontinued Drug Product Lists, and for the Drug Products
with Approval under Section 505 of the FD&C Act Administered by the Center
for Biologics Evaluation and Research. The publication may include
additional information that the Agency deems appropriate to disseminate.
Prior to the 6th Edition, the publication had excluded OTC drug products
and drug products with approval under Section 505 of the FD&C Act
administered by the Center for Biologics Evaluation and Research. The 1984
Amendments required the Agency to begin publishing an up-to-date list of all
marketed drug products, OTC as well as prescription, that have been approved
for safety and efficacy and for which new drug applications are required.
Under the FD&C Act, some drug products are given tentative approvals. The
Agency will not include drug products with tentative approvals in the List.
Tentative approval lists are available on FDAs website at Drug Approval
Reports. When the tentative approval becomes a full approval through a
subsequent action letter to the applicant, the Agency will list the drug
product and the final approval date in the appropriate approved drug product
list.
Distributors or repackagers of products on the List are not identified.
Because distributors or repackagers are not required to notify FDA when they
shift their sources of supply from one approved manufacturer to another, it
is not possible to maintain complete information linking product approval
with the distributor or repackager handling the products.
1.2 Therapeutic Equivalence-Related Terms

Newly approved products are added to parts 1, 2, or 3, of the List, depending on the dispensing
requirements (prescription or OTC) or approval authority, unless the Orange Book staff is
otherwise notified before publication.

vi

Pharmaceutical Equivalents. Drug products are considered pharmaceutical

equivalents if they contain the same active ingredient(s), are of the same
dosage form, route of administration and are identical in strength or
concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).
Pharmaceutically equivalent drug products are formulated to contain the same
amount of active ingredient in the same dosage form and to meet the same or
compendial or other applicable standards (i.e., strength, quality, purity,
and identity), but they may differ in characteristics such as shape, scoring
configuration, release mechanisms, packaging, excipients (including colors,
flavors, preservatives), expiration time, and, within certain limits,
labeling.
Pharmaceutical Alternatives. Drug products are considered pharmaceutical
alternatives if they contain the same therapeutic moiety, but are different
salts, esters, or complexes of that moiety, or are different dosage forms or
strengths (e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline
phosphate complex, 250mg capsules; quinidine sulfate, 200mg tablets vs.
quinidine sulfate, 200mg capsules). Different dosage forms and strengths
within a product line by a single manufacturer are thus pharmaceutical
alternatives, as are extended-release products when compared with immediaterelease or standard-release formulations of the same active ingredient.
Therapeutic Equivalents. Drug products are considered to be therapeutic
equivalents only if they are pharmaceutical equivalents and if they can be
expected to have the same clinical effect and safety profile when
administered to patients under the conditions specified in the labeling.
FDA classifies as therapeutically equivalent those products that meet the
following general criteria: (1) they are approved as safe and effective;
(2) they are pharmaceutical equivalents in that they (a) contain identical
amounts of the same active drug ingredient in the same dosage form and route
of administration, and (b) meet compendial or other applicable standards of
strength, quality, purity, and identity; (3) they are bioequivalent in that
(a) they do not present a known or potential bioequivalence problem, and they
meet an acceptable in vitro standard, or (b) if they do present such a known
or potential problem, they are shown to meet an appropriate bioequivalence
standard; (4) they are adequately labeled; (5) they are manufactured in
compliance with Current Good Manufacturing Practice regulations. The concept
of therapeutic equivalence, as used to develop the List, applies only to drug
products containing the same active ingredient(s) and does not encompass a
comparison of different therapeutic agents used for the same condition (e.g.,
meperidine hydrochloride vs. morphine sulfate for the treatment of pain).
Any drug product in the List repackaged and/or distributed by other than the
applicant is considered to be therapeutically equivalent to the applicants
drug product even if the applicants drug product is single source or coded
as non-equivalent (e.g., BN). Also, distributors or repackagers of an
applicants drug product are considered to have the same code as the
applicant. Therapeutic equivalence determinations are not made for
unapproved, off-label uses.
FDA considers drug products to be therapeutically equivalent if they meet
the criteria outlined above, even though they may differ in certain other
characteristics such as shape, scoring configuration, release mechanisms,
packaging, excipients (including colors, flavors, preservatives), expiration
date/time and minor aspects of labeling (e.g., the presence of specific
pharmacokinetic information) and storage conditions. When such differences
are important in the care of a particular patient, it may be appropriate for
the prescribing physician to require that a specific product be dispensed as
a medical necessity. With this limitation, however, FDA believes that
products classified as therapeutically equivalent can be substituted with the

vii

full expectation that the substituted product will produce the same clinical
effect and safety profile as the prescribed product.
Strength. Strength refers to the amount of drug substance (active
ingredient) contained in, delivered, or deliverable from a drug product. Note
that if the criteria the Agency establishes for determining and expressing
the amount of drug substance in a product evolves over time, the Agency
generally does not intend to revise the expressions of strength for drug
products already included in the List, but rather intends to apply the
criteria prospectively to drug products added to the List.
The strength of drug products in the List is generally expressed in terms
of the amount of drug substance (active ingredient) in the drug product, but
is sometimes expressed in terms of the amount of the active moiety. For
example, certain drug products included in the List include a designation of
EQ next to their expression of strength. This EQ designation generally
is used in connection with salt drug products to indicate that the strength
of such drug product is being expressed in terms of the equivalent strength
of the active moiety (e.g., EQ 200MG BASE), rather than in terms of the
strength of the active ingredient.
Bioavailability. This term means the rate and extent to which the active
ingredient or active moiety is absorbed from a drug product and becomes
available at the site of action. For drug products that are not intended to
be absorbed into the bloodstream, bioavailability may be assessed by
measurements intended to reflect the rate and extent to which the active
ingredient or active moiety becomes available at the site of action.
Bioequivalent Drug Products. This term describes pharmaceutical equivalent
or pharmaceutical alternative products that display comparable
bioavailability when studied under similar experimental conditions. Section
505 (j)(8)(B) of the FD&C Act describes one set of conditions under which a
test and reference listed drug (see Section 1.4) shall be considered
bioequivalent:
the rate and extent of absorption of the [test] drug do not show a
significant difference from the rate and extent of absorption of the
[reference] drug when administered at the same molar dose of the
therapeutic ingredient under similar experimental conditions in either
a single dose or multiple doses; or
the extent of absorption of the [test] drug does not show a significant
difference from the extent of absorption of the [reference] drug when
administered at the same molar dose of the therapeutic ingredient under
similar experimental conditions in either a single dose or multiple
doses and the difference from the [reference] drug in the rate of
absorption of the drug is intentional, is reflected in its proposed
labeling, is not essential to the attainment of effective body drug
concentrations on chronic use, and is considered medically
insignificant for the drug.
Where these above methods are not applicable (e.g., for drug products that
are not intended to be absorbed into the bloodstream), other in vivo or in
vitro test methods to demonstrate bioequivalence may be appropriate.
For example, bioequivalence may sometimes be demonstrated using an in
vitro bioequivalence standard, especially when such an in vitro test has been
correlated with human in vivo bioavailability data. In other situations,
bioequivalence may sometimes be demonstrated through comparative clinical
trials or pharmacodynamic studies.

viii

1.3 Further Guidance on Bioequivalence

FDAs regulations and guidance documents provide additional information
regarding bioequivalence and bioavailability, including methodologies and
statistical criteria used to establish the bioequivalence of drug products. 2
1.4 Reference Listed Drug
A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug
identified by FDA as the drug product upon which an applicant relies in
seeking approval of its ANDA.
FDA has identified in the Prescription Drug Product and OTC Drug Product
Lists those reference listed drugs to which the in vivo bioequivalence
(reference standard) and, in some instances, the in vitro bioequivalence of
the applicant's product is compared. By designating a single reference
listed drug as the standard to which all generic versions must be shown to be
bioequivalent, FDA hopes to avoid possible significant variations among
generic drugs and their brand name counterpart. Such variations could result
if generic drugs were compared to different drugs.
However, in some instances when a listed drug is not designated as the
reference listed drug and/or not shown to be bioequivalent to the reference
listed drug, such listed drug may be shielded from generic competition. An
applicant wishing to market a generic version of a listed drug that is not
designated as the reference listed drug may petition the Agency through the
citizen petition procedure (see 21 CFR 10.25(a) and CFR 10.30). If the
citizen petition is approved, the listed drug will be designated as an
additional reference listed drug, in which case an ANDA citing the designated
reference listed drug may be submitted. Section 1.7, Therapeutic Equivalence
Evaluations Codes (products meeting necessary bioequivalence requirements)
explains the character coding system (e.g., AB, AB1, AB2, AB3...) for
multisource drug products listed under the same heading with two reference
listed drugs.
In addition, there are two situations in which two listed drugs that have
been shown to be bioequivalent to each other have both been designated as
reference listed drugs. The first situation is when the in vivo
determination of bioequivalence is self-evident and a waiver of any in vivo
bioequivalence may be granted. The second situation is when the
bioequivalence of two listed products may be determined through in vitro
methodology.
Reference listed drugs are identified by the symbol "+" in the
Prescription and Over-the-Counter (OTC) Drug Product Lists. These identified
reference listed drugs represent the best judgment of the Office of
Bioequivalence at this time. The Prescription and OTC Drug Product Lists
2 We note that prior editions of the Preface to the Orange Book included a
section entitled Statistical Criteria for Bioequivalence. Please see FDAs
regulations and guidance documents for additional information regarding
bioequivalence and bioavailability. See FDA Drugs guidance Web page at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/de
fault.htm; FDA Drugs guidance (Product-Specific Recommendations for Generic
Drug Development) Web page at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/uc
m075207.htm; see generally 21 CFR part 320.

ix

identify reference drugs for approved drug products. It is recommended that

an applicant planning to conduct an in vivo bioequivalence study, or planning
to manufacture a batch of a drug product for which an in vivo waiver of
bioequivalence will be requested, submit a controlled correspondence to the
Office of Generic Drugs to confirm the appropriate reference listed drug.
1.5 General Policies and Legal Status
The List contains public information and advice. It does not mandate the
drug products that are purchased, prescribed, dispensed, or substituted for
one another, nor does it, conversely, mandate the products that should be
avoided. To the extent that the List sets forth FDA's evaluations of the
therapeutic equivalence of drug products that have been approved, it contains
FDA's advice to the public, to practitioners, and to the states regarding
drug product selection. These evaluations do not constitute determinations
that any product is in violation of the FD&C Act or that any product is
preferable to any other. Therapeutic equivalence evaluations are a
scientific judgment based upon evidence, while generic substitution may
involve social and economic policy administered by the states, intended to
reduce the cost of drugs to consumers. To the extent that the List
identifies drug products approved under Section 505 of the FD&C Act, it sets
forth information that the Agency is required to publish and that the public
is entitled to under the Freedom of Information Act. Exclusion of a drug
product from the List does not necessarily mean that the drug product is
either in violation of Section 505 of the FD&C Act, or that such a product is
not safe or effective, or that such a product is not therapeutically
equivalent to other drug products. Rather, the exclusion is based on the
fact that FDA has not evaluated the safety, effectiveness, and quality of the
drug product.
1.6

Practitioner/User Responsibilities

Professional care and judgment should be exercised in using the List.

Evaluations of therapeutic equivalence for prescription drugs are based on
scientific and medical evaluations by FDA. Products evaluated as
therapeutically equivalent can be expected, in the judgment of FDA, to have
equivalent clinical effect and no difference in their potential for adverse
effects when used under the conditions of their labeling. However, these
products may differ in other characteristics such as shape, scoring
configuration, release mechanisms, packaging, excipients (including colors,
flavors, preservatives), expiration date/time, and, in some instances,
labeling. If products with such differences are substituted for each other,
there is a potential for patient confusion due to differences in color or
shape of tablets, inability to provide a given dose using a partial tablet if
the proper scoring configuration is not available, or decreased patient
acceptance of certain products because of flavor. For example, there may
also be allergic reactions in rare cases due to a coloring or a preservative
ingredient, as well as differences in cost to the patient.
FDA evaluation of therapeutic equivalence in no way relieves practitioners
of their professional responsibilities in prescribing and dispensing such
products with due care and with appropriate information to individual
patients. In those circumstances where the characteristics of a specific
product, other than its active ingredient, are important in the therapy of a
particular patient, the physician's specification of that product is
appropriate. Pharmacists must also be familiar with the expiration
dates/times and labeling directions for storage of the different products,
particularly for reconstituted products, to assure that patients are properly
advised when one product is substituted for another.

Multisource and single-source drug products. FDA has evaluated for

therapeutic equivalence only multisource prescription drug products approved
under Section 505 of the FD&C Act, which in most instances means those
pharmaceutical equivalents available from more than one manufacturer. For
such products, a therapeutic equivalence code is included and, in addition,
product information is highlighted in bold face and underlined. Those
products with approved applications that are single-source (i.e., there is
only one approved product available for that active ingredient, dosage form,
route of administration, and strength) are also included on the List, but no
therapeutic equivalence code is included with such products. Any drug
product in the List repackaged and/or distributed by other than the applicant
(e.g., an authorized generic) is considered to be therapeutically equivalent
to the applicants drug product even if the applicants drug product is
single source or coded as non-equivalent (e.g., BN). Also, although not
identified in the List, distributors or repackagers of an applicants drug
product are considered to have the same code as the applicant. The details
of these codes and the policies underlying them are discussed in Section 1.7,
Therapeutic Equivalence Evaluations Codes.
Products on the List are identified by the names of the holders of
approved applications (applicants) who may not necessarily be the
manufacturer of the product. There are numerous entities other than the
applicant that may be involved in the development, manufacturing, and/or
marketing of a product. The applicant may have had its product manufactured
by a contract manufacturer and may simply be distributing the product for
which it has obtained approval. In many instances, however, the manufacturer
of the product is also the applicant. The name of the manufacturer is
permitted by regulation to appear on the label, even when the manufacturer is
not the marketer.
Although the products on the List are identified by the names of the
applicants, circumstances, such as changing corporate ownership, have
sometimes made identification of the applicant difficult. The Agency
believes, based on continuing document review and communication with firms,
that the applicant designations on the List are, in most cases, correct.
To relate firm name information on a product label to that on the List,
the following should be noted: the applicant's name always appears on the
List. This applies whether the applicant (firm name on the Form FDA 356h in
the application) is the marketer (firm name in largest letters on the label)
or not. However, the applicant's name may not always appear on the label of
the product.
If the applicant is the marketer, its name appears on the List and on the
label; if the applicant is not the marketer, and the Agency is aware of a
corporate relationship (e.g., parent and subsidiary) between the applicant
and the marketer, the name of the applicant appears on the List and both firm
names may appear on the label. Firms with known corporate relationships are
displayed in Appendix B. If there is no known corporate relationship between
the applicant and the marketer, the applicant's name appears on the List;
however, unless the applicant is the manufacturer, packager, or distributor,
the applicant's name may not appear on the label. In this case, the
practitioner, from labeling alone, will not be able to relate the marketed
product to an applicant cited in the List, and hence to a specific approved
drug product. In such cases, to assure that the product in question is the
subject of an approved application, the firm named on the label should be
contacted.
To relate trade name (proprietary name) information on a product label to
that on the List, the following should be noted: if the applicant is the

xi

marketer, its name appears on the List and on the label; if the Agency is
aware of a corporate relationship between the applicant and the marketer, the
trade name (proprietary name) of the drug product (established name of the
active ingredient, if no trade name exists) appears on the List. If a
corporate relationship exists between an applicant and a marketer and both
firms are distributing the drug product, the FDA reserves the right to select
the trade name of either the marketer or the applicant to appear on the List.
If there is no known corporate relationship between the applicant and the
marketer, the established drug name (i.e., non-proprietary name) appears on
the List.
Every product on the List is subject at all times to regulatory action.
From time to time, approved products may be found in violation of one or more
provisions of the FD&C Act. In such circumstances, the Agency may commence
appropriate enforcement action to correct the violation, if necessary, by
securing removal of the product from the market by voluntary recall, seizure,
or other enforcement actions. Such regulatory actions are, however,
independent of the inclusion of a product on the List. The main criterion
for inclusion of a product is that it has an application with an effective
approval that has not been withdrawn for safety or efficacy reasons. FDA
believes that retention of a violative product on the List will not have any
significant adverse health consequences, because other legal mechanisms are
available to the Agency to prevent the product's actual marketing. FDA may
however, change a product's therapeutic equivalence rating if the
circumstances giving rise to the violation change or otherwise call into
question the data upon which the Agency's assessment of whether a product
meets the criteria for therapeutic equivalence was made.
1.7 Therapeutic Equivalence Evaluations Codes
The coding system for therapeutic equivalence evaluations is constructed
to allow users to determine quickly whether the Agency has evaluated a
particular approved product as therapeutically equivalent to other
pharmaceutically equivalent products (first letter) and to provide additional
information on the basis of FDA's evaluations (second letter). With some
exceptions (e.g., therapeutic equivalence evaluations for certain 505(b)(2)
applications), the therapeutic equivalence evaluation date is the same as the
approval date.
The two basic categories into which multisource drugs have been placed are
indicated by the first letter of the relevant therapeutic equivalence code as
follows:
A Drug products that FDA considers to be therapeutically equivalent to
other pharmaceutically equivalent products, i.e., drug products for which:
(1) there are no known or suspected bioequivalence problems. These are
designated AA, AN, AO, AP, or AT, depending on the dosage form; or
(2) actual or potential bioequivalence problems have been resolved with
adequate in vivo and/or in vitro evidence supporting
bioequivalence. These are designated AB.
B Drug products that FDA at this time, considers not to be
therapeutically equivalent to other pharmaceutically equivalent products,
i.e.,
drug products for which actual or potential bioequivalence problems
have not been resolved by adequate evidence of bioequivalence. Often
the problem is with specific dosage forms rather than with the active

xii

ingredients.
or B*.

These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX,

Individual drug products have been evaluated as therapeutically equivalent

to the reference product in accordance with the definitions and policies
outlined below:
"A" CODES
Drug products that are considered to be therapeutically equivalent to other pharmaceutically
equivalent products.
"A" products are those for which actual or potential bioequivalence
problems have been resolved with adequate in vivo and/or in vitro evidence
supporting bioequivalence. Drug products designated with an "A" code fall
under one of two main policies:
(1)

for those active ingredients or dosage forms for which no in vivo

bioequivalence issue is known or suspected, the information necessary to
show bioequivalence between pharmaceutically equivalent products is
presumed and considered self-evident based on other data in the
application for some dosage forms (e.g., solutions) or satisfied by a
showing that an acceptable in vitro dissolution standard is met. A
therapeutically equivalent rating is assigned such products so long as
they are manufactured in accordance with Current Good Manufacturing
Practice regulations and meet the other requirements of their approved
applications (these are designated AA, AN, AO, AP, or AT, depending on
the dosage form, as described below); or

(2) for those DESI drug products containing active ingredients or dosage
forms that have been identified by FDA as having actual or potential
bioequivalence problems, and for post-1962 drug products in a dosage
form presenting a potential bioequivalence problem, an evaluation of
therapeutic equivalence is assigned to pharmaceutical equivalents only
if the approved application contains adequate scientific evidence
establishing through in vivo and/or in vitro studies the bioequivalence
of the product to a selected reference product (these products are
designated as AB).
There are some general principles that may affect the substitution of
pharmaceutically equivalent products in specific cases. Prescribers and
dispensers of drugs should be alert to these principles so as to deal
appropriately with situations that require professional judgment and
discretion.
There may be labeling differences among pharmaceutically equivalent
products that require attention on the part of the health professional. For
example, pharmaceutically equivalent powders to be reconstituted for
administration as oral or injectable liquids may vary with respect to their
expiration time or storage conditions after reconstitution. An FDA
evaluation that such products are therapeutically equivalent is applicable
only when each product is reconstituted, stored, and used under the
conditions specified in the labeling of that product.
The Agency may use notes in this publication to point out special
situations such as potential differences between two drug products that have
been evaluated as bioequivalent and otherwise therapeutically equivalent,
when they should be brought to the attention of health professionals. These
notes are contained in Section 1.8, Description of Certain Special
Situations.

xiii

For example, in rare instances, there may be variations among

therapeutically equivalent products in their use or in conditions of
administration. Such differences may be due to patent or exclusivity rights
associated with such use. When such variations may, in the Agency's opinion,
affect prescribing or substitution decisions by health professionals, a note
may be added to Section 1.8.
Also, occasionally a situation may arise in which changes in a listed drug
product after its approval (for example, a change in dosing interval) may
have an impact on the substitutability of already approved generic versions
of that product that were rated by the Agency as therapeutically equivalent
to the listed product. When such changes in the listed drug product are
considered by the Agency to have a significant impact on therapeutic
equivalence, the Agency will change the therapeutic equivalence ratings for
other versions of the drug product unless the manufacturers of those other
versions of the product provide additional information to assure equivalence
under the changed conditions. Pending receipt of the additional data, the
Agency may add a note to Section 1.8, or, in rare cases, may even change the
therapeutic equivalence rating.
In some cases (e.g., Isolyte S w/ Dextrose 5% in Plastic Container and
Plasma-Lyte 148 and Dextrose 5% in Plastic Container), closely related
products are listed as containing the same active ingredients, but in
somewhat different amounts. In determining which of these products are
pharmaceutically equivalent, the Agency has considered products to be
pharmaceutically equivalent with labeled strengths of an ingredient that do
not vary by more than 1%.
Different salts, esters or other noncovalent derivatives (such as a
complex, chelate, or clathrate) of the same active moiety are regarded as
different active ingredients. For the purpose of this publication, products
containing such different active ingredients are considered pharmaceutical
alternatives and thus not therapeutically equivalent. Anhydrous and hydrated
entities, as well as different polymorphs, are considered to be the same
active ingredient and are expected to meet the same standards for identity to
be considered pharmaceutical equivalents and therapeutic equivalents.
The codes in this book are not intended to preclude health care
professionals from converting pharmaceutically different concentrations into
pharmaceutical equivalents using accepted professional practice.
Where package size variations have therapeutic implications, products so
packaged have not been considered pharmaceutically equivalent. For example,
some oral contraceptives are supplied in 21-tablet and 28-tablet packets; the
28-tablet packets contain 7 placebo or iron tablets. These two packaging
configurations are not regarded as pharmaceutically equivalent; thus, they
are not designated as therapeutically equivalent.
Preservatives may differ among some therapeutically equivalent drug
products. Differences in preservatives and other inactive ingredients do not
affect FDA's evaluation of therapeutic equivalence except in cases where
these components may influence bioequivalence or routes of administration.
The specific sub-codes for those drugs evaluated as therapeutically
equivalent and the policies underlying these sub-codes follow:
AA Products in conventional dosage forms not presenting bioequivalence problems

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Products coded as AA contain active ingredients and dosage forms that are
not regarded as presenting either actual or potential bioequivalence
problems or drug quality or standards issues. However, all oral dosage
forms must, nonetheless, meet an appropriate in vitro bioequivalence
standard that is acceptable to the Agency in order to be approved.
AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements
Multisource drug products listed under the same heading (i.e., identical
active ingredients(s), dosage form, and route(s) of administration) and
having the same strength (see Section 1.2, Therapeutic Equivalence-Related
Terms, Strength) generally will be coded AB if data and information are
submitted demonstrating bioequivalence.
In certain instances, a number is added to the end of the AB code to make
a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes
are assigned only in situations when more than one reference listed drug
of the same strength has been designated under the same heading. Two or
more reference listed drugs are generally selected only when there are at
least two potential reference drug products that are not identified as
bioequivalent to each other. If a study is submitted that demonstrates
bioequivalence to a specific listed drug product, the generic product will
be given the same three-character code as the reference listed drug it was
compared against. For example, Adalat CC and Procardia XL, extendedrelease tablets, are listed under the active ingredient nifedipine. These
drug products, listed under the same heading, are not bioequivalent to
each other. Adalat CC and Procardia XL have been assigned ratings of
AB1 and AB2, respectively. Generic drug products deemed by FDA to be
bioequivalent to Adalat CC and Procardia XL have been approved. As a
result, the generic drug products bioequivalent to Adalat CC have been
assigned a rating of AB1 and those bioequivalent to Procardia XL have
been assigned a rating of AB2. (The assignment of an AB1 or AB2 rating to
a specific product does not imply product preference.) Even though drug
products of distributors and/or repackagers are not included in the List,
they are considered therapeutically equivalent to the applicants drug
product if the applicants drug product is rated either with an AB or
three-character code or is single source in the List. Drugs coded as AB
under a heading are considered therapeutically equivalent only to other
drugs coded as AB under that heading. Drugs coded with a three-character
code under a heading are considered therapeutically equivalent only to
other drugs coded with the same three-character code under that heading.
AN Solutions and powders for aerosolization
Uncertainty regarding the therapeutic equivalence of aerosolized products
arises primarily because of differences in the drug delivery system.
Solutions and powders intended for aerosolization that are marketed for
use in any of several delivery systems are considered to be
pharmaceutically and therapeutically equivalent and are coded AN. Those
products that are compatible only with a specific delivery system or those
products that are packaged in and with a specific delivery system are
coded BN, unless they have met an appropriate bioequivalence standard and
are otherwise determined to be therapeutically equivalent. Solutions or
suspensions in a specific delivery system will be coded AN if the
bioequivalence standard is based upon in vitro methodology, if
bioequivalence needs to be demonstrated by in vivo methodology then the
drug products will be coded AB.
AO Injectable oil solutions

xv

The absorption of drugs in injectable (parenteral) oil solutions may vary

substantially with the type of oil employed as a vehicle and the
concentration of the active ingredient. Injectable oil solutions are
therefore considered to be pharmaceutically and therapeutically equivalent
only when the active ingredient, its concentration, and the type of oil
used as a vehicle are all identical.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous
solutions
It should be noted that even though injectable (parenteral) products under
a specific listing may be evaluated as therapeutically equivalent, there
may be important differences among the products in the general category,
Injectable; Injection. For example, some injectable products that are
rated therapeutically equivalent are labeled for different routes of
administration. In addition, some products evaluated as therapeutically
equivalent may have different preservatives or no preservatives at all.
Injectable products available as dry powders for reconstitution,
concentrated sterile solutions for dilution, or sterile solutions ready
for injection are pharmaceutical alternative drug products. They are not
rated as therapeutically equivalent (AP) to each other even if these
pharmaceutical alternative drug products are designed to produce the same
concentration prior to injection and are similarly labeled. Consistent
with accepted professional practice, it is the responsibility of the
prescriber, dispenser, or individual administering the product to be
familiar with a product's labeling to assure that it is given only by the
route(s) of administration stated in the labeling.
Certain commonly used large volume intravenous products in glass
containers are not included on the List (e.g., dextrose injection 5%,
dextrose injection 10%, sodium chloride injection 0.9%) since these
products are on the market without FDA approval and the FDA has not
published conditions for marketing such parenteral products under approved
NDAs. When packaged in plastic containers, however, FDA regulations
require approved applications prior to marketing. Approval then depends
on, among other things, the extent of the available safety data involving
the specific plastic component of the product. All large volume
parenteral products are manufactured under similar standards, regardless
of whether they are packaged in glass or plastic. Thus, FDA has no reason
to believe that the packaging container of large volume parenteral drug
products that are pharmaceutically equivalent would have any effect on
their therapeutic equivalence.
The strength of parenteral drug products generally is identified by both
the total drug content and the concentration of drug substance in a
container approved by FDA. 3 In the past, the strength of liquid
parenteral drug products in the Orange Book has not been fully displayed.
Rather, the strength of liquid parenteral drug products in the Orange Book
has been displayed in terms of concentration, expressed as xmg/mL. The
amount of dry powder or freeze dried powder in a container has always been
identified as the strength, expressed as xmg/vial.
With the finalization of the 1984 Amendments that characterized each
strength of a drug product as a listed drug, it became evident that the
format of the Orange Book should be changed to reflect each strength of a
parenteral solution. To this end, the Orange Book now displays the
3 The strengths of certain parenteral drug products, including contrast agents, may be expressed
as a percentage.

xvi

strength of all new approvals of parenteral solutions. Previously, we

would have displayed only the concentration of an approved parenteral
solution, e.g. 50mg/mL. If this drug product had a 20 mL and 60 mL
container approved, we would now display two product strengths for this
product, listing both total drug content and concentration of drug
substance in the relevant approved container, e.g. 1Gm / 20mL (50mg/mL)
and 3Gm / 60mL (50mg/mL).
AT Topical products
There are a variety of topical dosage forms available for dermatologic,
ophthalmic, otic, rectal, and vaginal administration, including creams,
gels, lotions, oils, ointments, pastes, solutions, sprays and
suppositories. Even though different topical dosage forms may contain the
same active ingredient and potency, these dosage forms are not considered
pharmaceutically equivalent. Therefore, they are not considered
therapeutically equivalent. All solutions and DESI drug products
containing the same active ingredient in the same topical dosage form for
which a waiver of in vivo bioequivalence has been granted and for which
chemistry and manufacturing processes are adequate to demonstrate
bioequivalence, are considered therapeutically equivalent and coded AT.
Pharmaceutically equivalent topical products that raise questions of
bioequivalence, including all post-1962 non-solution topical drug
products, are coded AB when supported by adequate bioequivalence data, and
BT in the absence of such data.
"B" CODES
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other
pharmaceutically equivalent products.
"B" products, for which actual or potential bioequivalence problems have
not been resolved by adequate evidence of bioequivalence, often have a
problem with specific dosage forms rather than with the active ingredients.
Drug products designated with a "B" code fall under one of three main
policies:
(1)

the drug products contain active ingredients or are manufactured in

dosage forms that have been identified by the Agency as having
documented bioequivalence problems or a significant potential for
such problems and for which no adequate studies demonstrating
bioequivalence have been submitted to FDA; or

(2)

the quality standards are inadequate or FDA has an insufficient basis

to determine therapeutic equivalence; or

(3)

the drug products are under regulatory review.

The specific coding definitions and policies for the "B" sub-codes are as
follows:
B* Drug products requiring further FDA investigation and review to determine therapeutic
equivalence
The code B* is assigned to products previously assigned an A or B code
when FDA receives new information that raises a significant question
regarding therapeutic equivalence that can be resolved only through

xvii

further Agency investigation and/or review of data and information

submitted by the applicant. The B* code signifies that the Agency will
take no position regarding the therapeutic equivalence of the product
until the Agency completes its investigation and review.
BC Extended-release dosage forms (capsules, injectables and tablets)
Extended-release tablets are formulated in such a manner as to make the
contained medicament available over an extended period of time following
ingestion.
Although bioavailability studies have been conducted on these dosage
forms, they may be subject to bioavailability differences, primarily
because applicants developing extended-release products for the same
active ingredient rarely employ the same formulation approach. FDA,
therefore, does not consider different extended-release dosage forms
containing the same active ingredient in equal strength to be
therapeutically equivalent unless equivalence between individual products
in both rate and extent has been specifically demonstrated through
appropriate bioequivalence studies. Extended-release products for which
such bioequivalence data have not been submitted are coded BC, while those
for which such data are available have been coded AB.
BD Active ingredients and dosage forms with documented bioequivalence problems
The BD code denotes products containing active ingredients with known
bioequivalence problems and for which adequate studies have not been
submitted to FDA demonstrating bioequivalence. Where studies showing
bioequivalence have been submitted, the product has been coded AB.
BE Delayed-release oral dosage forms
Where the drug may be destroyed or inactivated by the gastric juice or
where it may irritate the gastric mucosa, the use of enteric coatings is
indicated. Such coatings are intended to delay the release of the
medication until the tablet has passed through the stomach. Drug products
in delayed-release dosage forms containing the same active ingredients are
subject to significant differences in absorption. Unless otherwise
specifically noted, the Agency considers different delayed-release
products containing the same active ingredients as presenting a potential
bioequivalence problem and codes these products BE in the absence of
in vivo studies showing bioequivalence. If adequate in vivo studies have
demonstrated the bioequivalence of specific delayed-release products, such
products are coded AB.
BN Products in aerosol-nebulizer drug delivery systems
This code applies to drug solutions or powders that are marketed only as a
component of, or as compatible with, a specific drug delivery system.
There may, for example, be significant differences in the dose of drug and
particle size delivered by different products of this type. Therefore,
the Agency does not consider different metered aerosol dosage forms
containing the same active ingredient(s) in equal strengths to be
therapeutically equivalent unless the drug products meet an appropriate
bioequivalence standard; such products are coded AB.

xviii

BP Active ingredients and dosage forms with potential bioequivalence problems

FDA's bioequivalence regulations (21 CFR 320.33) contain criteria and
procedures for determining whether a specific active ingredient in a
specific dosage form has a potential for causing a bioequivalence problem.
It is FDA's policy to consider an ingredient meeting these criteria as
having a potential bioequivalence problem even in the absence of positive
data demonstrating inequivalence. Pharmaceutically equivalent products
containing these ingredients in oral dosage forms are coded BP until
adequate bioequivalence data are submitted, after which such products are
coded AB. Injectable suspensions containing an active ingredient
suspended in an aqueous or oleaginous vehicle have also been coded BP.
Injectable suspensions are subject to bioequivalence problems because
differences in particle size, polymorphic structure of the suspended
active ingredient, or the suspension formulation can significantly affect
the rate of release and absorption. FDA does not consider pharmaceutical
equivalents of these products bioequivalent without adequate evidence of
bioequivalence; such products would be coded AB.
BR Suppositories or enemas that deliver drugs for systemic absorption
The absorption of active ingredients from suppositories or enemas that are
intended to have a systemic effect (as distinct from suppositories
administered for local effect) can vary significantly from product to
product. Therefore, FDA considers pharmaceutically equivalent systemic
suppositories or enemas bioequivalent only if in vivo evidence of
bioequivalence is available. In those cases where in vivo evidence is
available, the product is coded AB. If such evidence is not available,
the products are coded BR.
BS Products having drug standard deficiencies
If the drug standards for an active ingredient in a particular dosage form
are found by FDA to be deficient so as to prevent an FDA evaluation of
either pharmaceutical or therapeutic equivalence, all drug products
containing that active ingredient in that dosage form are coded BS. For
example, if the standards permit a wide variation in pharmacologically
active components of the active ingredient such that pharmaceutical
equivalence is in question, all products containing that active ingredient
in that dosage form are coded BS.
BT Topical products with bioequivalence issues
This code applies mainly to post-1962 dermatologic, ophthalmic, otic,
rectal, and vaginal products for topical administration, including creams,
ointments, gels, lotions, pastes, and sprays, as well as suppositories not
intended for systemic drug absorption. Topical products evaluated as
having acceptable clinical performance, but that are not bioequivalent to
other pharmaceutically equivalent products or that lack sufficient
evidence of bioequivalence, will be coded BT.
BX Drug products for which the data are insufficient to determine therapeutic equivalence
The code BX is assigned to specific drug products for which the data that
have been reviewed by the Agency are insufficient to determine therapeutic
equivalence under the policies stated in this document. In these
situations, the drug products are presumed to be therapeutically

xix

inequivalent until the Agency has determined that there is adequate

information to make a full evaluation of therapeutic equivalence.
1.8 Description of Certain Special Situations
Certain drugs listed in the Orange Book present special situations that
merit further discussion. The following are descriptions of certain examples
of those special situations:
Amino Acid and Protein Hydrolysate Injections. These products differ in
the amount and kinds of amino acids they contain and, therefore, are not
considered pharmaceutical equivalents. For this reason, these products are
not considered therapeutically equivalent. At the same time, the Agency
believes that it is appropriate to point out that where nitrogen balance is
the sole therapeutic objective and individual amino acid content is not a
consideration, pharmaceutical alternatives with the same total amount of
nitrogen content may be considered therapeutically equivalent.
Gaviscon. Gaviscon is an OTC product that has been marketed since
September 1970. The active ingredients in this product, aluminum hydroxide
and magnesium trisilicate, were reviewed by the Agency's OTC Antacid Panel
and were considered to be safe and effective ingredients (Category I) by that
Panel. However, the tablet failed to pass the antacid test that is required
of all antacid products. The Agency, therefore, placed the tablet in
Category III for lack of effectiveness. A full NDA with clinical studies was
submitted by Marion Laboratories, Inc., and approved by FDA on December 9,
1983. Gaviscons activity in treating reflux acidity is made possible by
the physical-chemical properties of the inactive ingredients, sodium
bicarbonate and alginic acid. Therefore, all ANDAs that cite Gaviscon
tablets as the reference listed drug must contain the inactive ingredients
sodium bicarbonate and alginic acid. A full NDA will be required to support
the effectiveness of the drug product if different inactive ingredients are
to be substituted for sodium bicarbonate or alginic acid or if different
proportions of these ingredients are to be used.
Levothyroxine Sodium. Because there are multiple reference listed drugs of
levothyroxine sodium tablets and some reference listed drugs' sponsors have
conducted studies to establish their drugs' therapeutic equivalence to other
reference listed drugs, FDA has determined that its usual practice of
assigning two or three character TE codes may be potentially confusing and
inadequate for these drug products. Accordingly, FDA provides the following
explanation and chart of therapeutic equivalence evaluations for
levothyroxine sodium drug products.
Levothyroxine Sodium (Mylan ANDA 76187), Levoxyl (King Pharms NDA 021301),
Synthroid (Abbvie NDA 021402), and Levo-T (Alara NDA 021342) tablets have
been determined to be therapeutically equivalent to corresponding strengths
of Unithroid (Jerome Stevens NDA 021210) tablets.
Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), and
Unithroid (Jerome Stevens NDA 021210), tablets have been determined to be
therapeutically equivalent to corresponding strengths of Synthroid (Abbvie
NDA 021402) tablets.
Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210), and
Levothyroxine Sodium (Mylan ANDA 076187), tablets have been determined to be
therapeutically equivalent to corresponding strengths of Levoxyl (King Pharms
NDA 021301) tablets.
Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be

xx

therapeutically equivalent to corresponding strengths of Levothroid (Lloyd

NDA 021116) tablets.
The chart outlines TE codes for all 0.025mg products in the active section of
the Orange Book. Other product strengths may be similar. Therapeutic
equivalence has been established between products that have the same
AB+number TE code. More than one TE code may apply to some products. One
common TE code indicates therapeutic equivalence between products.
Trade Name

Applicant

Strength

UNITHROID

STEVENS J

0.025MG

LEVOXYL

KING PHARMS

0.025MG

LEVOTHYROXINE SODIUM
SYNTHROID
LEVO-T

MYLAN

0.025MG

ABBVIE

0.025MG

ALARA PHARM

0.025MG

TE
Code

Appl
No

Product
No

076187

001

AB1

021210

AB1

021301

AB1
AB1
AB1

021402
021342

001
001
001
001

SYNTHROID

ABBVIE

0.025MG

AB2

021402

001

LEVO-T

ALARA PHARM

0.025MG

AB2

021342

001

LEVOTHYROXINE SODIUM
UNITHROID

MYLAN

0.025MG

STEVENS J

0.025MG

AB2
AB2

076187
021210

001
001

LEVOXYL

KING PHARMS

0.025MG

AB3

021301

001

UNITHROID

STEVENS J

0.025MG

AB3

021210

001

LEVO-T

LEVOTHYROXINE SODIUM
LEVOTHROID

LEVOTHYROXINE SODIUM

ALARA PHARM

0.025MG

MYLAN

0.025MG

LLOYD

0.025MG

MYLAN

0.025MG

AB3
AB3
AB4
AB4

021342
076187
021116
076187

001
001
001
001

Patent Certification(s) and Reference Listed Drug based upon a suitability

petition. An ANDA that refers to a reference listed drug approved pursuant
to a suitability petition must demonstrate that the proposed product can be
expected to have the same therapeutic effect as the reference listed drug,
and it must include appropriate patent certification(s) and an exclusivity
statement with respect to the reference listed drug that served as the basis
for the approved suitability petition. This concept also applies to an ANDA
applicant that cites a reference listed drug that was based upon an NDA that
is still covered by patent(s) and/or exclusivity, e.g. a second RLD selected
for use in conducting bioequivalence studies.
Waived exclusivity. If an NDA submitted under section 505(b) of the FD&C
Act qualifies for exclusivity under the FD&C Act, the exclusivity is listed
in the Patent and Exclusivity Section of the Orange Book. If a drug product
has received this exclusivity, the FDA will not accept for review and/or will
delay the approval of a 505(b)(2) application or an ANDA under section 505(j)
of the FD&C Act, as applicable, in accordance with the relevant exclusivity.
If the listed drug is also protected by one or more patents, the approval
date for the 505(b)(2) application or ANDA will be determined based on an
analysis of the applicants patent certification(s) or statement(s) for each
relevant patent and the effect of relevant exclusivity listed in the Orange
Book. However, the holder of the NDA may waive its exclusivity as to any or
all 505(b)(2) and ANDA applications that might otherwise be blocked by such
NDA. If an NDA sponsor waives its right to the exclusivity protection,
qualified 505(b)(2) or ANDA applications may be accepted for review and/or

xxi

approved, as applicable, pursuant to the NDA holder's exclusivity being

waived. An NDA for which the holder has waived its exclusivity as to all
505(b)(2) and ANDA applications will be coded with a W in the Patent and
Exclusivity Section of the Orange Book. The applicant whose product might
otherwise be blocked by this listed drug should indicate in the exclusivity
statement that the holder of the listed drug has waived its exclusivity.
1.9 Therapeutic Equivalence Code Change for a Drug Entity
The Agency will use the following procedures when, in response to a
petition or on its own initiative, it is considering a change in the
therapeutic equivalence code for approved multisource drug products. Such
changes will generally occur when the Agency becomes aware of new scientific
information affecting the therapeutic equivalence of an entire category of
drug products in the List (e.g., information concerning the active ingredient
or the dosage form), rather than information concerning a single drug product
within the category. These procedures will be used when a change in
therapeutic equivalence code is under consideration for all drug products
found in the Prescription Drug Product List under a specific drug entity and
dosage form. The change may be from the code signifying that the drug does
not present a bioequivalence problem (e.g., AA) to a code signifying a
bioequivalence problem (e.g., BP), or vice versa. This procedure does not
apply to a change of a particular product code (e.g., a change from BP to AB
or from AB to BX).
Before making a change in a therapeutic equivalence code for an entire
category of drugs, the Agency will announce in the Introduction to the
Cumulative Supplement that it is considering the change and will invite
comment. Comments, along with scientific data, may be sent to the Director,
Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation
and Research, HFD-650, 7620 Standish Place, Rockville, MD 20855.
The comment period will generally be 60 days in length, and the closing
date for comments will be listed in the description of the proposed change
for each drug entity.
The most useful type of scientific data submitted to support comments is
an in vivo bioavailability/bioequivalence study conducted on batches of the
subject drug products. These submissions should present a full description
of the analytical procedures and equipment used, a validation of the
analytical methodology, including the standard curve, a description of the
method of calculating results, and a description of the pharmacokinetic and
statistical models used in analyzing the data. Anecdotal or testimonial
information is the least useful to the Agency, and such submissions are
discouraged. Copies of supporting reports published in the scientific
literature or unpublished material, however, are welcome.
1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product
The aforementioned procedure described in Section 1.9 does not apply to a
change in a single drug product code. For example, a change in a single drug
product's code from BP to AB as a result of the submission of an acceptable
bioequivalence study ordinarily will not be the subject of notice and comment
in the Cumulative Supplement. Likewise, a change in a single drug product's
code from AB to BX (e.g., as a result of new information raising a
significant question as to bioequivalence) does not require notice and
comment. The Agency's responsibility to provide the public with the Agency's
most current information related to therapeutic equivalence may require a

xxii

change in a drug product's code prior to any formal notice and opportunity
for the applicant to be heard. The publication in the Federal Register of a
proposal to withdraw approval of a drug product will ordinarily result in a
change in a product's code from AB to BX if this action has not already been
taken.
We recognize that certain drug products approved in 505(b)(2)
applications may not have therapeutic equivalence codes, and that FDA may
undertake therapeutic equivalence evaluations with respect to such drug
products. A person seeking to have a therapeutic equivalence rating for a
drug product approved in a 505(b)(2) application may petition the Agency
through the citizen petition procedure (see 21 CFR 10.25(a) and CFR 10.30).
1.11 Discontinued Section
Those drug products in the discontinued section of the Orange Book
(Discontinued Drug Product List) for which a determination has already been
made that the products were not withdrawn for safety or effectiveness reasons
have **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons** following the product strength.
Those drug products are only reflective of determinations made since 1995.
The identification of these drug products in the Discontinued Drug Product
List should avoid the submission of multiple citizen petitions for the same
drug product. FR notices no longer applicable are removed from the Annual
Edition (i.e., there is a currently marketed reference listed drug and no
applicable patent or exclusivity). The Orange Book FR Safety or
Effectiveness Determinations List, available on FDAs website, lists products
that have current and removed notices. The list is updated quarterly.
Notices issued during the year are added to the Electronic Orange Book Query
on FDAs website in the month they become effective.
Generally, approved products are added to the Discontinued Drug Product
List when the applicant notifies the Orange Book staff of the products notmarketed status. Products may also be added to the Discontinued Drug Product
List if annual reports indicate the product is no longer marketed or as a
result of other Agency administrative actions. Changes to the Orange Book
are not affected by the drug registration and listing requirements of Section
510 of the FD&C Act.
1.12 Changes to the Orange Book
Every effort is made to ensure the Annual Edition is current and
accurate. Applicants are requested to inform the FDA Orange Book staff of
any changes or corrections, including any change in a products marketing
status that would result in the product being moved to the Discontinued Drug
Product List. FDA notes that 21 CFR 314.81(b)(3)(iv) requires an applicant
to submit a notice to the Agency within fifteen working days of the
withdrawal from sale of a drug product. In addition, a request to include a
newly approved product in the Discontinued Drug Product List, rather than
parts 1, 2 or 3 of the List (as discussed in Section 1.1), must be submitted
to the Orange Book staff by the end of the month in which the product is
approved to ensure that the product is not included in the active portions
of the next published Orange Book update. To the extent that conventions for
describing product identification information (i.e., active ingredients,
dosage forms, routes of administration, product names, applicants, strengths)
evolve over time, the Agency generally does not intend to revise such
information for drug products already included in the List, but rather
intends to apply the change prospectively to drug products added to the List.
We can be contacted by email at orangebook@fda.hhs.gov.
mail to:

xxiii

Send Changes by

FDA/CDER Orange Book Staff

Office of Generic Drugs
7620 Standish Place
Rockville, MD 20855-2773
1.13 Availability of the Edition
Commencing with the 25th edition, the Annual Edition and current monthly
Cumulative Supplement are available in a Portable Document Format (PDF) at
the EOB home page, Electronic Orange Book Query, by clicking on Publications.
The PDF annual format duplicates previous paper versions except for the
Orphan Products Designations and Approvals List. An annual subscription of
the PDF format may be obtained from the U.S. Government Printing Office, 866512-1800.

xxiv

2. HOW TO USE THE DRUG PRODUCT LISTS

2.1

Key Sections for Using the Drug Product Lists

This publication contains illustrations, along with Drug Product Lists,

indices, and lists of abbreviations and terms which facilitate their use.
Illustrations. The annotated Drug Product Illustration, see Section 2.2,
and the Therapeutic Equivalence Evaluations Illustration, see Section 2.3, are
offered to provide further clarification. These depict the format found in
the Prescription Drug Product List (the only list in which therapeutic
equivalence evaluation codes are displayed).
Drug Product Lists. The Prescription and OTC Drug Product Lists,
arranged alphabetically by active ingredient(s), contain product
identification information (active ingredients, dosage forms, routes of
administration, product names, applicants, strengths) for single and multiple
ingredient drug products. Also shown are the application number and drug
product number (FDA internal computer data use only) and approval dates for
those drug products approved on or after January 1, 1982. The application
number preceded by N is a New Drug Application (NDA or commonly the
innovator). The application number preceded by an A is an Abbreviated New
Drug Application (ANDA or commonly the generic).
The Discontinued Drug Product List, arranged alphabetically by active
ingredient(s), contains product identification information (dosage form,
product name, strength, and application number).
If a prescription drug product is available from more than one source
(multisource), a therapeutic equivalence code will appear in front of the
applicant's name. If a product is therapeutically equivalent to one or more
products or to an appropriate reference, it will be designated with a code
beginning with "A" and the entry will be underlined and printed in bold font
for emphasis.
Active ingredient headings for multiple ingredient (combination) drug
products are arranged alphabetically. For purposes of this publication, this
alphabetical sort takes precedence over United States Pharmacopeia official
monograph order (i.e., Reserpine, Hydralazine Hydrochloride,
Hydrochlorothiazide). For example, product information labeled as Reserpine,
Hydrochlorothiazide and Hydralazine Hydrochloride appears under the active
ingredient heading Hydralazine Hydrochloride; Hydrochlorothiazide; Reserpine.
A cross-reference to the product information (for prescription and OTC
products) appears for each additional active ingredient in the product. For
combination drug products, the ingredient strengths are separated by
semicolons and appear in the same relative sequence as the ingredients in the
heading. Available strengths of the dosage form from an applicant appear on
separate lines.
To use the Drug Product Lists, determine by alphabetical order the
ingredient under which the product information is listed, using the Product
Name Index, if necessary. Then, find the ingredient in the applicable Drug
Product List. Proceed to the dosage form and route of administration and
compare products within that ingredient heading only. Therapeutic equivalence
or inequivalence for prescription products is determined on the basis of the
therapeutic equivalence codes provided within that specific dosage form and
route heading. The OTC Drug Product List, Discontinued Drug Product List, and

2-1

Drug Products with Approval under Section 505 of the Act Administered by the
Center for Biologics Evaluation and Research List have their data arranged
similarly.
The Discontinued Drug Product List contains approved products that have
never been marketed, have been discontinued from marketing and we have not
determined that they were withdrawn for safety or effectiveness reasons, are
for military use, or have had their approvals withdrawn for other than safety
or efficacy reasons subsequent to being discontinued from marketing. All
products having a "@" in the December Cumulative Supplement of the previous
Edition List have been added to the Discontinued Drug Product List appearing
in this Edition. In addition, approved drug products that are not in the
commercial distribution channel e.g., approved drug products in applications
for export only are also listed in the Discontinued Drug Product List.
Product Name Index (Prescription and OTC Drug Product Lists). This is an
index of drug products by trade name or established name of the active
ingredient, if no trade name exists. The second term of each entry indicates
the active ingredient name under which product information can be found in the
appropriate Drug Product List. For those drug products with multiple active
ingredients, only the first active ingredient (in alphabetical order) will
appear. OTC products are so designated.
Product Name Index Listed by Applicant (Prescription and OTC Drug Product
Lists). This is an index that cross-references applicants to drug products.
The bolded and underlined entry represents the applicant name abbreviation
used in this publication. Each complete applicant name that is represented by
the abbreviated name is marked with an asterisk (*). Listed under each
complete applicant name is the first alphabetically arranged ingredient under
which product information can be found in the appropriate Drug Product List.
OTC products are so designated. To use the Drug Product Lists, determine by
alphabetical order the ingredient under which the product information is
listed, using the Product Name Index, if appropriate.
Uniform Terms. To improve readability, uniform terms are used to
designate dosage forms, routes of administration, and abbreviations used to
express strengths. These terms are listed in Appendix C. In some cases, the
terms used may differ from those used in product labels and other labeling.

2-2

2.2

DRUG PRODUCT ILLUSTRATION

SINGLE INGREDIENT

ACTIVE INGREDIENT

MEPERIDINE HYDROCHLORIDE

DOSAGE FORM; ROUTE OF ADMINISTRATION

INJECTABLE;INJECTION
HEXANON

TRADE OR GENERIC NAMES

AP
AP
AP
AP

REFERENCE LISTED DRUG

THERAPEUTIC EQUIVALENCE (TE)

CODE FOR MULTISOURCE PRODUCT
SINGLE SOURCE PRODUCT (NO TE CODE)

+ PAGE PHARMA
+
+
+

25MG/ML
50MG/ML
75MG/ML
100MG/ML

N013111
N013111
N013111
N013111

001
002
003
004

AUG
AUG
AUG
JAN

22,
22,
22,
04,

1983
1983
1983
1989

MEPERIDINE HCL
AP
GREENBERG PHARM
AP
AP
AP

25MG/ML
50MG/ML
75MG/ML
100MG/ML

A064890
A064890
A064890
A064890

001
002
003
004

FEB
FEB
FEB
MAR

29,
29,
29,
08,

1987
1987
1987
1992

AP

TIMOKIM LLC
JOHNSON MED
KENDRA PHARM

10MG/ML A099225 001 DEC 12, 1995

25MG/ML A099226 001 NOV 27, 1993
150MG/ML A079444 001 OCT 31, 1999

APPLICANT
AVAILABLE STRENGTH(S) OF A PRODUCT
APPLICATION NUMBER AND PRODUCT NUMBER
PRODUCT NUMBER IS FOR FDA INTERNAL COMPUTER DATA USE ONLY
APPROVAL DATE

MULTIPLE INGREDIENTS WITH PRODUCT INFORMATION

ALPHABETICALLY SORTED BY
ACTIVE INGREDIENT
PRODUCT INFORMATION

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

TABLET;ORAL
HYDROCHLOROTHIAZIDE, RESERPINE AND HYDRALAZINE HCL
REINWALD INC
25MG;15MG;0.1MG A069808 001 JAN 18, 1982

THIS EXAMPLE IS FOR PURPOSE OF ILLUSTRATION ONLY.

PRESCRIPTION DRUG PRODUCT LIST.

IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE

2.3 THERAPEUTIC EQUIVALENCE EVALUATIONS ILLUSTRATION

DRUG PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN "A") UNDER AN INGREDIENT AND DOSAGE FORM HEADING
ARE CONSIDERED THERAPEUTICALLY EQUIVALENT ONLY TO OTHER PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN
A") AND NOT TO THOSE CODED BP (OR ANY CODE BEGINNING WITH "B") AND ANY PRODUCTS NOT LISTED. DRUG
PRODUCTS CODED BP (OR ANY CODE BEGINNING WITH A "B") ARE NOT CONSIDERED THERAPEUTICALLY EQUIVALENT TO ANY
OTHER PRODUCT. FOR A COMPLETE EXPLANATION OF THE TE CODES REFER TO SECTION 1.7 OF THE INTRODUCTION.

SULFASALAZINE
TABLET; ORAL
FAZINE
AB

500MG

A042999 001

500MG

A042222 001

500MG

A041297 001

500MG

A042999 001

BROWN

500MG

A041297 001

SOUTH

500MG

A067627 001

PARKLAND
SULAZINE

PRODUCTS CONSIDERED THERAPEUTICALLY

AB

EQUIVALENT TO EACH OTHER

URSA

SULFASALAZINE
PRODUCTS CONSIDERED NOT THERAPEUTICALLY

BP

BROWN

EQUIVALENT TO ANY OTHER PRODUCTS LISTED

SULFASALAZINE
TABLET; ORAL
FAZINE
AB
PARKLAND
PRODUCTS CONSIDERED NOT THERAPEUTICALLY

SULFASALAZINE

EQUIVALENT TO EACH OTHER

NOTE: BOLD
EQUIVALENT.

FONT

AND

UNDERLINING

BP

DENOTES

MULTISOURCE

THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY.

PRESCRIPTION DRUG PRODUCT LIST.

PRODUCTS

WHICH

ARE

CONSIDERED

THERAPEUTICALLY

IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-1(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ABACAVIR SULFATE

SOLUTION;ORAL

ZIAGEN

+ VIIV HLTHCARE
TABLET;ORAL

ABACAVIR SULFATE

AB
APOTEX INC
AB
AUROBINDO PHARMA LTD
AB
HETERO LABS LTD III
AB
MYLAN PHARMS INC
ZIAGEN

AB
+ VIIV HLTHCARE

EQ 20MG BASE/ML

N020978 001 Dec 17, 1998

EQ
EQ
EQ
EQ

A201570
A077844
A091560
A091294

300MG
300MG
300MG
300MG

BASE
BASE
BASE
BASE

EQ 300MG BASE

001
001
001
001

Dec
Dec
Sep
Jun

17,
17,
13,
18,

2012

2012

2013

2012

N020977 001 Dec 17, 1998

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

TABLET;ORAL

TRIUMEQ

+ VIIV HLTHCARE
EQ 600MG BASE;EQ 50MG BASE;300MG

N205551 001 Aug 22, 2014

ABACAVIR SULFATE; LAMIVUDINE

TABLET;ORAL

EPZICOM

+ VIIV HLTHCARE

N021652 001 Aug 02, 2004

EQ 600MG BASE;300MG

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

TABLET;ORAL

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

AB
LUPIN LTD
EQ 300MG BASE;150MG;300MG
TRIZIVIR

AB
+ VIIV HLTHCARE
EQ 300MG BASE;150MG;300MG

N021205 001 Nov 14, 2000

ABIRATERONE ACETATE

TABLET;ORAL

ZYTIGA

+ JANSSEN BIOTECH

250MG

N202379 001 Apr 28, 2011

333MG
333MG
333MG

A200143 001 Nov 18, 2013

A202229 001 Jul 16, 2013

A200142 001 Mar 11, 2014

333MG

N021431 001 Jul 29, 2004

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A202271
A202271
A202271
A078441
A078441
A078441
A091053
A091053
A091053
A078470
A078470
A078470
A090912
A090912
A090912
A091343
A091343
A091343
A077532
A077532
A077532

25MG
50MG
100MG

N020482 004 May 29, 1997

N020482 001 Sep 06, 1995

N020482 002 Sep 06, 1995

ACAMPROSATE CALCIUM

TABLET, DELAYED RELEASE;ORAL

ACAMPROSATE CALCIUM

AB
BARR LABS DIV TEVA
AB
GLENMARK GENERICS
AB
MYLAN PHARMS INC
CAMPRAL

AB
+ FOREST LABS
ACARBOSE

TABLET;ORAL

ACARBOSE

AB
EMCURE PHARMS LTD
AB
AB
AB
IMPAX LABS
AB
AB
AB
MYLAN
AB
AB
AB
ROXANE
AB
AB
AB
STRIDES PHARMA
AB
AB
AB
VIRTUS PHARM
AB
AB
AB
WATSON LABS
AB
AB
PRECOSE

AB
+ BAYER HLTHCARE
AB
AB

A202912 001 Dec 05, 2013

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Feb
Feb
Feb
May
May
May
Jan
Jan
Jan
May
May
May
Jul
Jul
Jul
Oct
Oct
Oct
May
May
May

07,
07,
07,
14,
14,
14,
06,
06,
06,
07,
07,
07,
27,
27,
27,
17,
17,
17,
07,
07,
07,

2012

2012

2012

2009

2009

2009

2011

2011

2011

2008

2008

2008

2011

2011

2011

2013

2013

2013

2008

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-2(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ACEBUTOLOL HYDROCHLORIDE

CAPSULE;ORAL

ACEBUTOLOL HYDROCHLORIDE

AB
AMNEAL PHARM
AB
AB
MYLAN
AB
SECTRAL

AB
PROMIUS PHARMA
AB
+
ACETAMINOPHEN

SOLUTION;IV (INFUSION)

ACETAMINOPHEN

FRESENIUS KABI USA
OFIRMEV

+ MALLINCKRODT IP

EQ
EQ
EQ
EQ

200MG
400MG
200MG
400MG

BASE
BASE
BASE
BASE

A075047
A075047
A074288
A074288

001
002
001
002

Dec
Dec
Apr
Apr

30,
30,
24,
24,

1999

1999

1995

1995

EQ 200MG BASE
EQ 400MG BASE

N018917 001 Dec 28, 1984

N018917 003 Dec 28, 1984

1GM/100ML (10MG/ML)

N204767 001 Oct 28, 2015

1GM/100ML (10MG/ML)

N022450 001 Nov 02, 2010

ACETAMINOPHEN; BUTALBITAL

TABLET;ORAL

BUTALBITAL AND ACETAMINOPHEN

AA
LARKEN LABS INC
325MG;50MG
AA
TEDOR PHARMA INC
325MG;50MG
BUTAPAP

AA
+ MIKART
325MG;50MG
ALLZITAL

LARKEN LABS INC
325MG;25MG
BUTALBITAL AND ACETAMINOPHEN

+ NEXGEN PHARMA
300MG;50MG
ACETAMINOPHEN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

+ MIKART
325MG;50MG;40MG
+ NEXGEN PHARMA
300MG;50MG;40MG
SOLUTION;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

+ MIKART
325MG/15ML;50MG/15ML;40MG/15ML
TABLET;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

AA
HIKMA PHARMS LLC
325MG;50MG;40MG
AA
LANNETT HOLDINGS INC
325MG;50MG;40MG
AA
MALLINCKRODT
325MG;50MG;40MG
AA
MIKART
325MG;50MG;40MG
AA
+ VINTAGE PHARMS
325MG;50MG;40MG

A203484 002 Dec 04, 2015

A205120 001 Oct 30, 2015

A089987 001 Oct 26, 1992

A203484 001 Dec 04, 2015

A090956 001 Aug 23, 2011

A089007 001 Mar 17, 1986

A040885 001 Nov 16, 2009

A040387 001 Jan 31, 2003

A089718
A200243
A087804
A089175
A040511

001
001
001
001
001

Jun
Sep
Jan
Jan
Aug

12,
13,
24,
21,
27,

1995

2012

1985

1987

2003

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE;ORAL

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

AB
HIKMA INTL PHARMS
325MG;50MG;40MG;30MG
AB
NEXGEN PHARMA INC
325MG;50MG;40MG;30MG
AB
VINTAGE PHARMS
325MG;50MG;40MG;30MG
FIORICET W/ CODEINE

AB
+ ACTAVIS LABS UT INC
325MG;50MG;40MG;30MG
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

NEXGEN PHARMA INC
300MG;50MG;40MG;30MG

A076560 002 Jul 19, 2012

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE;ORAL

TREZIX

WRASER PHARMS LLC
320.5MG;30MG;16MG

A204785 001 Nov 26, 2014

ACETAMINOPHEN; CODEINE PHOSPHATE

SOLUTION;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

AA
HI TECH PHARMA
120MG/5ML;12MG/5ML
AA
MIKART
120MG/5ML;12MG/5ML
AA
+ PHARM ASSOC
120MG/5ML;12MG/5ML
AA
VINTAGE PHARMS
120MG/5ML;12MG/5ML
AA
WOCKHARDT
120MG/5ML;12MG/5ML
SUSPENSION;ORAL

CAPITAL AND CODEINE

+ VALEANT PHARMS LLC
120MG/5ML;12MG/5ML

A075618 001 Mar 23, 2001

A076560 001 Jun 10, 2004

A075929 001 Apr 22, 2002

N020232 001 Jul 30, 1992

A040119
A089450
A087508
A091238
A087006

001 Apr 26, 1996

001 Oct 27, 1992

001

001 Nov 10, 2011

001

A086024 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-3(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ACETAMINOPHEN; CODEINE PHOSPHATE

TABLET;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

AA
AMNEAL PHARMS NY
300MG;30MG
AA
AUROLIFE PHARMA LLC
300MG;15MG
AA
300MG;30MG
AA
300MG;60MG
AA
+ MALLINCKRODT INC
300MG;15MG
AA
300MG;30MG
AA
300MG;60MG
AA
SUN PHARM INDS LTD
300MG;30MG
AA
300MG;60MG
AA
TEVA
300MG;15MG
AA
300MG;30MG
AA
+
300MG;60MG
AA
VINTAGE
300MG;15MG
AA
300MG;30MG
AA
VINTAGE PHARMS
300MG;60MG
TYLENOL W/ CODEINE NO. 3

AA
+ JANSSEN PHARMS
300MG;30MG
TYLENOL W/ CODEINE NO. 4

AA
JANSSEN PHARMS
300MG;60MG
ACETAMINOPHEN; HYDROCODONE BITARTRATE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

AA
+ MIKART
325MG/15ML;7.5MG/15ML
AA
PHARM ASSOC
325MG/15ML;7.5MG/15ML
AA
VINTAGE PHARMS
325MG/15ML;7.5MG/15ML
AA
VISTAPHARM
325MG/15ML;7.5MG/15ML
+ MIKART
300MG/15ML;10MG/15ML
+ PHARM ASSOC
325MG/15ML;10MG/15ML
TABLET;ORAL

ANEXSIA 5/325

AA
MALLINCKRODT
325MG;5MG
ANEXSIA 7.5/325

AA
MALLINCKRODT
325MG;7.5MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN

AA
AMNEAL PHARMS NY
325MG;5MG
AA
325MG;10MG
AA
AUROLIFE PHARMA LLC
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
MALLINCKRODT
325MG;10MG
AA
+ MIKART
300MG;5MG
AA
+
300MG;7.5MG
AA
+
300MG;10MG
AA
+
325MG;2.5MG
AA
325MG;7.5MG
AA
SUN PHARM INDS INC
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
TRIS PHARMA INC
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
VINTAGE PHARMS
300MG;5MG
AA
300MG;7.5MG
AA
300MG;10MG
AA
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
NORCO

AA
ACTAVIS LABS FL INC
325MG;2.5MG
AA
325MG;5MG
AA
+
325MG;7.5MG
AA
+
325MG;10MG
AA
+ WATSON LABS
325MG;5MG

A040779
A202800
A202800
A202800
A040419
A040419
A040419
A085868
A087083
A088627
A088628
A088629
A089990
A089805
A089828

001
001
002
003
001
002
003
001

001

001
001
001
001
001
001

May
Apr
Apr
Apr
May
May
May

29,
15,
15,
15,
31,
31,
31,

2008

2013

2013

2013

2001

2001

2001

Mar
Mar
Mar
Sep
Sep
Sep

06,
06,
06,
30,
30,
30,

1985

1985

1985

1988

1988

1988

Sep
May
Jul
Jan
Feb
Apr

25,
10,
19,
25,
25,
18,

2003

2013

2011

2012

2010

2008

A085055 003

A085055 004

A040482
A040838
A040894
A200343
A040881
A040834

001
001
001
001
001
001

A040409 001 Oct 20, 2000

A040405 001 Sep 08, 2000

A040736
A040746
A201013
A201013
A201013
A040400
A040658
A040556
A040556
A040846
A040432
A090118
A090118
A090118
A202214
A202214
A202214
A090415
A090415
A090415
A040655
A040656
A040355

001
001
001
002
003
001
001
002
001
001
001
001
002
003
001
002
003
001
002
003
001
001
001

Aug
Aug
Apr
Apr
Apr
Jul
Jan
Mar
Jun
Jun
Jan
Dec
Dec
Dec
Mar
Mar
Mar
Jan
Jan
Jan
Jan
Jan
May

25,
25,
11,
11,
11,
26,
19,
24,
23,
09,
22,
23,
23,
23,
27,
27,
27,
24,
24,
24,
19,
19,
31,

2006

2006

2012

2012

2012

2000

2006

2006

2004

2010

2003

2008

2008

2008

2013

2013

2013

2011

2011

2011

2006

2006

2000

A040148
A040148
A040148
A040148
A040099

004
005
003
001
001

Jul
Jul
Sep
Feb
Jun

07,
07,
12,
14,
25,

2014

2014

2000

1997

1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-4(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

SOLUTION;ORAL

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN

AA
VINTAGE PHARMS
325MG/5ML;5MG/5ML
ROXICET

AA
+ ROXANE
325MG/5ML;5MG/5ML
TABLET;ORAL

OXYCET

AA
MALLINCKRODT
325MG;5MG
OXYCODONE AND ACETAMINOPHEN

AA
ACTAVIS ELIZABETH
325MG;2.5MG
AA
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
ALVOGEN INC
325MG;7.5MG
AA
325MG;10MG
AA
AMNEAL PHARMS NY
325MG;5MG
AA
325MG;10MG
AA
AUROLIFE PHARMA LLC
325MG;2.5MG
AA
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
COASTAL PHARMS
325MG;2.5MG
AA
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
MALLINCKRODT
325MG;7.5MG
AA
325MG;10MG
AA
RHODES PHARMS
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
SUN PHARM INDS INC
325MG;2.5MG
AA
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
VINTAGE PHARMS
325MG;2.5MG
AA
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
WATSON LABS
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
PERCOCET

AA
+ VINTAGE PHARMS LLC
325MG;2.5MG
AA
+
325MG;5MG
AA
+
325MG;7.5MG
AA
+
325MG;10MG
ROXICET

AA
ROXANE
325MG;5MG
OXYCODONE AND ACETAMINOPHEN

+ MIKART
300MG;2.5MG
+
300MG;5MG
+
300MG;7.5MG
+
300MG;10MG
TABLET, EXTENDED RELEASE;ORAL

XARTEMIS XR

+ MALLINCKRODT INC
325MG;7.5MG
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

TABLET;ORAL

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

AB
ALLIED PHARMA INC
325MG;37.5MG
AB
AMNEAL PHARMS
325MG;37.5MG
AB
APOTEX INC
325MG;37.5MG
AB
MICRO LABS LTD INDIA
325MG;37.5MG
AB
MYLAN
325MG;37.5MG
AB
PAR PHARM
325MG;37.5MG
AB
SUN PHARM INDS INC
325MG;37.5MG
AB
ZYDUS PHARMS USA INC
325MG;37.5MG
ULTRACET

AB
+ JANSSEN PHARMS
325MG;37.5MG

A203573 001 Dec 18, 2014

A089351 001 Dec 03, 1986

A087463 001 Dec 07, 1983

A201447
A201447
A201447
A201447
A202677
A202677
A040777
A040778
A201972
A201972
A201972
A201972
A090177
A090177
A090177
A090177
A040545
A040545
A201278
A201278
A201278
A090535
A090535
A090535
A090535
A090733
A040105
A090734
A090734
A040171
A040535
A040535

001
002
003
004
001
002
001
001
001
002
003
004
001
002
003
004
001
002
001
002
003
001
002
003
004
001
001
001
002
001
001
002

Apr
Apr
Apr
Apr
Jul
Jul
Nov
Nov
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Jun
Jun
Aug
Aug
Aug
Dec
Dec
Dec
Dec
Jul
Jul
Jul
Jul
Oct
Sep
Sep

12,
12,
12,
12,
26,
26,
27,
27,
15,
15,
15,
15,
20,
20,
20,
20,
30,
30,
28,
28,
28,
26,
26,
26,
26,
11,
30,
11,
11,
30,
05,
05,

2013

2013

2013

2013

2012

2012

2007

2007

2013

2013

2013

2013

2008

2008

2008

2008

2004

2004

2014

2014

2014

2013

2013

2013

2013

2013

1996

2013

2013

1997

2003

2003

A040330
A040330
A040434
A040434

001
002
001
002

Jun
Jun
Nov
Nov

25,
25,
23,
23,

1999

1999

2001

2001

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2005

2005

2005

2005

A087003 001

A040608
A040608
A040608
A040608

001
002
003
004

N204031 001 Mar 11, 2014

A202076
A090485
A078778
A201952
A077858
A076475
A077184
A090460

001
001
001
001
001
001
001
001

Mar
Dec
Apr
Dec
Sep
Apr
Dec
Sep

30,
09,
07,
14,
26,
21,
16,
06,

2012

2009

2014

2012

2008

2005

2005

2012

N021123 001 Aug 15, 2001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-5(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ACETAZOLAMIDE

CAPSULE, EXTENDED RELEASE;ORAL

ACETAZOLAMIDE

AB
HERITAGE PHARMS INC
500MG
AB
ZYDUS PHARMS USA INC
500MG
DIAMOX

AB
+ TEVA BRANDED PHARM
500MG
TABLET;ORAL

ACETAZOLAMIDE

AB
LANNETT
250MG
AB
MUTUAL PHARM
125MG
AB
TARO
125MG
AB
+
250MG
ACETAZOLAMIDE SODIUM

INJECTABLE;INJECTION

ACETAZOLAMIDE SODIUM

AP
EUROHLTH INTL SARL
AP
SAGENT AGILA
AP
+ X GEN PHARMS
ACETAZOLAMIDE SODIUM

AP
EMCURE PHARMS LTD

A090779 001 Jul 14, 2011

A040904 001 Dec 10, 2008

N012945 001

A084840
A089752
A040195
A040195

001

001 Jun 22, 1988

001 May 28, 1997

002 May 28, 1997

EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL

A040089 001 Feb 28, 1995

A200880 001 May 09, 2012

A040784 001 Dec 10, 2008

EQ 500MG BASE/VIAL

A202693 001 Dec 19, 2014

ACETIC ACID, GLACIAL

SOLUTION;IRRIGATION, URETHRAL

ACETIC ACID 0.25% IN PLASTIC CONTAINER

AT
B BRAUN
250MG/100ML
AT
BAXTER HLTHCARE
250MG/100ML
AT
HOSPIRA
250MG/100ML
SOLUTION/DROPS;OTIC

ACETIC ACID

AT
TARO
2%
AT
VINTAGE
2%
AT
+ WOCKHARDT
2%
VOSOL

AT
HI TECH PHARMA
2%

N012179 001

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

SOLUTION/DROPS;OTIC

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE

+ BAUSCH AND LOMB
2%;0.79%

A040063 001 Feb 25, 1994

N018161 001

N018523 001 Feb 19, 1982

N017656 001

A088638 001 Sep 06, 1984

A040607 001 Feb 24, 2005

A040166 001 Jul 26, 1996

ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS;OTIC

ACETASOL HC

AT
ACTAVIS MID ATLANTIC
2%;1%
HYDROCORTISONE AND ACETIC ACID

AT
TARO
2%;1%
AT
VINTAGE
2%;1%
VOSOL HC

AT
+ HI TECH PHARMA
2%;1%

N012770 001

ACETOHYDROXAMIC ACID

TABLET;ORAL

LITHOSTAT

+ MISSION PHARMA

250MG

N018749 001 May 31, 1983

ACETYLCHOLINE CHLORIDE

FOR SOLUTION;OPHTHALMIC

MIOCHOL-E

+ BAUSCH AND LOMB

20MG/VIAL

N020213 001 Sep 22, 1993

6GM/30ML (200MG/ML)

N021539 001 Jan 23, 2004

6GM/30ML (200MG/ML)
6GM/30ML (200MG/ML)
6GM/30ML (200MG/ML)

A203173 001 Mar 24, 2015

A200644 001 Nov 07, 2012

A203624 001 Jun 19, 2015

10%
20%
10%
20%

A204674
A203853
A073664
A074037

ACETYLCYSTEINE

INJECTABLE;INTRAVENOUS

ACETADOTE

AP
+ CUMBERLAND PHARMS
ACETYLCYSTEINE

AP
AKORN INC
AP
INNOPHARMA LICENSING
AP
MYLAN INSTITUTIONAL
SOLUTION;INHALATION, ORAL

ACETYLCYSTEINE

AN
ALVOGEN INC
AN
AN
HOSPIRA
AN

A087143 001 Jan 13, 1982

A088759 001 Mar 04, 1985

A040609 001 Feb 06, 2006

001
001
001
001

Feb
Jun
Aug
Aug

11,
21,
30,
30,

2014

2012

1994

1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-6(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ACETYLCYSTEINE

SOLUTION;INHALATION, ORAL

ACETYLCYSTEINE

AN
+ LUITPOLD
AN
+

10%
20%

A072489 001 Jul 28, 1995

A072547 001 Jul 28, 1995

ACITRETIN

CAPSULE;ORAL

ACITRETIN

AB
BARR LABS INC
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
SIGMAPHARM LABS LLC
AB
AB
AB
AB
TEVA PHARMS USA
AB
AB
WATSON LABS INC
AB
AB
AB
SORIATANE

AB
STIEFEL LABS INC
AB
AB
AB
+

10MG
25MG
10MG
17.5MG
22.5MG
25MG
10MG
17.5MG
22.5MG
25MG
17.5MG
22.5MG
10MG
17.5MG
22.5MG
25MG

A091455
A091455
A202148
A203707
A203707
A202148
A204633
A204633
A204633
A204633
A202897
A202897
A202552
A202552
A202552
A202552

001
002
001
001
002
002
001
002
003
004
001
002
001
002
003
004

Apr
Apr
Sep
Sep
Sep
Sep
May
May
May
May
Apr
Apr
Dec
Dec
Dec
Dec

04,
04,
10,
10,
10,
10,
22,
22,
22,
22,
04,
04,
23,
23,
23,
23,

2013

2013

2015

2015

2015

2015

2015

2015

2015

2015

2013

2013

2015

2015

2015

2015

10MG
17.5MG
22.5MG
25MG

N019821
N019821
N019821
N019821

001
003
004
002

Oct
Aug
Aug
Oct

28,
06,
06,
28,

1996

2009

2009

1996

ACLIDINIUM BROMIDE

POWDER, METERED;INHALATION

TUDORZA PRESSAIR

+ ASTRAZENECA PHARMS

0.4MG/INH

N202450 001 Jul 23, 2012

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE;ORAL

SEMPREX-D

+ AUXILIUM PHARMS LLC
8MG;60MG
ACYCLOVIR

CAPSULE;ORAL

ACYCLOVIR

AB
APOTEX INC
AB
CADILA PHARMS LTD
AB
DAVA PHARMS INC
AB
MYLAN
AB
RANBAXY
AB
STASON
AB
TEVA
ZOVIRAX

AB
+ DELCOR ASSET
CREAM;TOPICAL

ZOVIRAX

+ VIB
OINTMENT;TOPICAL

ACYCLOVIR

AB
AMNEAL PHARMS
AB
MYLAN PHARMS INC
ZOVIRAX

AB
+ VALEANT BERMUDA
SUSPENSION;ORAL

ACYCLOVIR

AB
ACTAVIS MID ATLANTIC
AB
HI TECH PHARMA
ZOVIRAX

AB
+ DELCOR ASSET
TABLET;BUCCAL

SITAVIG

+ INNOCUTIS HOLDINGS
TABLET;ORAL

ACYCLOVIR

AB
APOTEX INC

N019806 001 Mar 25, 1994

200MG
200MG
200MG
200MG
200MG
200MG
200MG

A075677
A201445
A074833
A074727
A074975
A075090
A074578

001
001
001
001
001
001
001

200MG

N018828 001 Jan 25, 1985

5%

N021478 001 Dec 30, 2002

5%
5%

A204605 001 Jun 18, 2014

A202459 001 Apr 03, 2013

5%

N018604 001 Mar 29, 1982

200MG/5ML
200MG/5ML

A074738 001 Apr 28, 1997

A077026 001 Jun 07, 2005

200MG/5ML

N019909 001 Dec 22, 1989

50MG

N203791 001 Apr 12, 2013

400MG

A077309 001 Sep 29, 2005

Sep
Mar
Apr
Apr
Sep
Jan
Apr

28,
06,
22,
22,
30,
26,
22,

2005

2014

1997

1997

1998

1999

1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-7(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ACYCLOVIR

TABLET;ORAL

ACYCLOVIR

AB
AB
CADILA PHARMS LTD
AB
AB
CARLSBAD
AB
AB
DAVA PHARMS INC
AB
AB
HETERO LABS LTD V
AB
AB
MYLAN
AB
AB
SUN PHARM INDS LTD
AB
AB
TEVA
AB
AB
ZYDUS PHARMS USA INC
AB
ZOVIRAX

AB
DELCOR ASSET
AB
+

800MG
400MG
800MG
400MG
800MG
400MG
800MG
400MG
800MG
400MG
800MG
400MG
800MG
400MG
800MG
400MG
800MG

A077309
A202168
A202168
A075382
A075382
A074946
A074946
A203834
A203834
A075211
A075211
A074980
A074980
A074556
A074556
A204314
A204314

400MG
800MG

N020089 001 Apr 30, 1991

N020089 002 Apr 30, 1991

ACYCLOVIR SODIUM

INJECTABLE;INJECTION

ACYCLOVIR SODIUM

AP
AUROBINDO PHARMA LTD
EQ 50MG BASE/ML
AP
BEDFORD
EQ 500MG BASE/VIAL
AP
+ FRESENIUS KABI USA
EQ 50MG BASE/ML
AP
+
EQ 500MG BASE/VIAL
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE

+ HIKMA MAPLE
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
ACYCLOVIR SODIUM

+ BEDFORD
EQ 1GM BASE/VIAL
ACYCLOVIR; HYDROCORTISONE

CREAM;TOPICAL

XERESE

+ VALEANT BERMUDA
ADAPALENE

CREAM;TOPICAL

ADAPALENE

AB
FOUGERA PHARMS
DIFFERIN

AB
+ GALDERMA LABS LP
GEL;TOPICAL

ADAPALENE

AB
ACTAVIS MID ATLANTIC
AB
GLENMARK GENERICS
AB
PLIVA HRVATSKA DOO
AB
TOLMAR
DIFFERIN

AB
+ GALDERMA LABS LP
AB
+
LOTION;TOPICAL

DIFFERIN

+ GALDERMA LABS LP
SOLUTION;TOPICAL

ADAPALENE

+ CALL INC

A203701
A074596
A074930
A075015

002
001
002
001
002
001
002
001
002
001
002
001
002
002
003
001
002

001
002
001
001

Sep
Nov
Nov
Apr
Apr
Nov
Nov
Oct
Oct
Sep
Sep
Sep
Sep
Apr
Apr
Aug
Aug

Oct
Apr
May
Apr

29,
15,
15,
30,
30,
19,
19,
29,
29,
28,
28,
30,
30,
22,
22,
19,
19,

11,
22,
13,
30,

2005

2013

2013

1999

1999

1997

1997

2013

2013

1998

1998

1998

1998

1997

1997

2014

2014

2013

1997

1998

1998

A074885 001 Dec 19, 1997

A074885 002 Dec 19, 1997

A074596 001 Apr 22, 1997

5%;1%

N022436 001 Jul 31, 2009

0.1%

A090824 001 Jun 30, 2010

0.1%

N020748 001 May 26, 2000

0.3%
0.1%
0.1%
0.3%

A201000
A091314
A090962
A200298

0.1%
0.3%

N020380 001 May 31, 1996

N021753 001 Jun 19, 2007

0.1%

N022502 001 Mar 17, 2010

0.1%

A204593 001 Jan 05, 2016

ADAPALENE; BENZOYL PEROXIDE

GEL;TOPICAL

ADAPALENE AND BENZOYL PEROXIDE

AB
ACTAVIS MID ATLANTIC
0.1%;2.5%
EPIDUO

AB
+ GALDERMA LABS LP
0.1%;2.5%
EPIDUO FORTE

+ GALDERMA LABS
0.3%;2.5%

001
001
001
001

Oct
Jul
Jun
Jun

27,
01,
02,
14,

2014

2010

2010

2012

A203790 001 Sep 30, 2015

N022320 001 Dec 08, 2008

N207917 001 Jul 15, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-8(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ADEFOVIR DIPIVOXIL

TABLET;ORAL

ADEFOVIR DIPIVOXIL

AB
SIGMAPHARM LABS LLC
HEPSERA

AB
+ GILEAD
ADENOSINE

INJECTABLE;INJECTION

ADENOCARD

AP
+ ASTELLAS
ADENOSINE

AP
AKORN
AP
BEDFORD
AP
EUROHLTH INTL SARL
AP
FRESENIUS KABI USA
AP
GLAND PHARMA LTD
AP
LUITPOLD
AP
MYLAN LABS LTD
AP
SOLUTION;IV (INFUSION)

ADENOSCAN

AP
+ ASTELLAS
AP
+
ADENOSINE

AP
AKORN
AP
AP
EMCURE PHARMS LTD
AP
AP
HOSPIRA INC
AP
AP
SAGENT STRIDES
AP
AP
TEVA PHARMS USA
AP
AFATINIB DIMALEATE

TABLET;ORAL

GILOTRIF

BOEHRINGER INGELHEIM

10MG

A202051 001 Aug 29, 2013

10MG

N021449 001 Sep 20, 2002

3MG/ML

N019937 002 Oct 30, 1989

3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML

A078076
A076404
A076500
A077133
A077283
A090010
A078640
A078686

60MG/20ML (3MG/ML)
90MG/30ML (3MG/ML)

N020059 001 May 18, 1995

N020059 002 May 18, 1995

60MG/20ML
90MG/30ML
60MG/20ML
90MG/30ML
60MG/20ML
90MG/30ML
60MG/20ML
90MG/30ML
60MG/20ML
90MG/30ML

A090450
A090450
A202313
A202313
A203883
A203883
A090212
A090212
A077425
A077425

(3MG/ML)
(3MG/ML)
(3MG/ML)
(3MG/ML)
(3MG/ML)
(3MG/ML)
(3MG/ML)
(3MG/ML)
(3MG/ML)
(3MG/ML)

001
001
001
001
001
001
001
001

001
002
001
002
001
002
001
002
001
002

Oct
Jun
Jun
Apr
Jun
Apr
Mar
May

Oct
Oct
Sep
Sep
Mar
Mar
Mar
Mar
Aug
Aug

31,
16,
16,
27,
14,
28,
21,
13,

02,
02,
15,
15,
24,
24,
28,
28,
29,
29,

2008

2004

2004

2005

2007

2009

2014

2009

2014

2014

2014

2014

2014

2014

2014

2014

2013

2013

EQ 20MG BASE
EQ 30MG BASE
EQ 40MG BASE

N201292 001 Jul 12, 2013

N201292 002 Jul 12, 2013
N201292 003 Jul 12, 2013

ALBENDAZOLE

TABLET;ORAL

ALBENZA

+ AMEDRA PHARMS LLC

200MG

N020666 001 Jun 11, 1996

ALBUMIN HUMAN

INJECTABLE;INJECTION

OPTISON

+ GE HEALTHCARE

10MG/ML

N020899 001 Dec 31, 1997

100uCi/10ML (10uCi/ML)
500uCi/0.5ML
1,000uCi/ML

N017836 003 Jun 08, 2004

N017836 001

N017836 002

0.5mCi/VIAL
1mCi/VIAL

N017837 001

N017837 002

EQ 0.09MG BASE/INH

N021457 001 Oct 29, 2004

EQ 0.09MG BASE/INH

N020503 001 Aug 15, 1996

EQ 0.09MG BASE/INH

N020983 001 Apr 19, 2001

ALBUMIN IODINATED I-125 SERUM

INJECTABLE;INJECTION

JEANATOPE

ISO TEX
+
ALBUMIN IODINATED I-131 SERUM

INJECTABLE;INJECTION

MEGATOPE

+ ISO TEX
+
ALBUTEROL SULFATE

AEROSOL, METERED;INHALATION

PROAIR HFA

BX
+ TEVA BRANDED PHARM
PROVENTIL-HFA

BX
+ 3M
VENTOLIN HFA

BX
+ GLAXOSMITHKLINE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-9(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ALBUTEROL SULFATE

POWDER, METERED;INHALATION

PROAIR RESPICLICK

+ TEVA BRANDED PHARM
EQ
SOLUTION;INHALATION

ACCUNEB

AN
+ MYLAN SPECLT
EQ
AN
+
EQ
ALBUTEROL SULFATE

AN
+ BAUSCH AND LOMB
EQ
AN
HI TECH PHARMA
EQ
AN
EQ
AN
LANDELA PHARM
EQ
AN
+ MYLAN SPECLT
EQ
AN
NEPHRON
EQ
AN
EQ
AN
EQ
AN
EQ
AN
RITEDOSE CORP
EQ
AN
TEVA PHARMS
EQ
AN
WATSON LABS
EQ
AN
EQ
AN
WATSON LABS INC
EQ
SYRUP;ORAL

ALBUTEROL SULFATE

AA
AMNEAL PHARMS
EQ
AA
G AND W LABS INC
EQ
AA
HI TECH PHARMA
EQ
AA
+ TEVA
EQ
AA
VINTAGE
EQ
AA
VISTAPHARM
EQ
TABLET;ORAL

ALBUTEROL SULFATE

AB
MUTUAL PHARM
EQ
AB
EQ
AB
MYLAN
EQ
AB
+
EQ
TABLET, EXTENDED RELEASE;ORAL

ALBUTEROL SULFATE

AB
MYLAN
EQ
AB
EQ
VOSPIRE ER

AB
DAVA PHARMS INC
EQ
AB
+
EQ

0.090MG BASE/INH

N205636 001 Mar 31, 2015

0.021% BASE
0.042% BASE

N020949 002 Apr 30, 2001

N020949 001 Apr 30, 2001

0.5% BASE
0.083% BASE
0.5% BASE
0.083% BASE
0.083% BASE
0.021% BASE
0.042% BASE
0.083% BASE
0.5% BASE
0.083% BASE
0.083% BASE
0.021% BASE
0.042% BASE
0.083% BASE

A075050
A075063
A074543
A077569
A072652
A076355
A076355
A074880
A075664
A077839
A075343
A077772
A077772
A076370

001
001
001
001
001
002
001
001
001
001
001
001
002
001

Jun
Feb
Jan
Apr
Feb
Mar
Jun
Sep
Jun
Dec
Nov
Sep
Sep
Nov

18,
09,
15,
04,
21,
31,
28,
17,
26,
16,
09,
25,
25,
24,

1998

1999

1998

2006

1992

2010

2004

1997

2001

2008

1999

2007

2007

2003

2MG
2MG
2MG
2MG
2MG
2MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A079241
A074454
A074749
A073419
A078105
A077788

001
001
001
001
001
001

May
Sep
Jan
Mar
Dec
Jun

12,
25,
30,
30,
27,
26,

2010

1995

1998

1992

2006

2007

2MG
4MG
2MG
4MG

BASE
BASE
BASE
BASE

A072637
A072637
A072894
A072894

002
001
002
001

Dec
Dec
Jan
Jan

05,
05,
17,
17,

1989

1989

1991

1991

4MG BASE
8MG BASE

A078092 002 Jan 29, 2007

A078092 001 Jan 29, 2007

4MG BASE
8MG BASE

A076130 002 Sep 26, 2002

A076130 003 Sep 26, 2002

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

SOLUTION;INHALATION

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

AN
CIPLA LTD
EQ 0.083% BASE;0.017%
AN
NEPHRON
EQ 0.083% BASE;0.017%
AN
RITEDOSE CORP
EQ 0.083% BASE;0.017%
AN
TEVA PHARMS
EQ 0.083% BASE;0.017%
AN
WATSON LABS
EQ 0.083% BASE;0.017%
DUONEB

AN
+ MYLAN SPECLT
EQ 0.083% BASE;0.017%
SPRAY, METERED;INHALATION

COMBIVENT RESPIMAT

+ BOEHRINGER INGELHEIM
EQ 0.1MG BASE/INH;0.02MG/INH
ALCAFTADINE

SOLUTION/DROPS;OPHTHALMIC

LASTACAFT

+ ALLERGAN
ALCLOMETASONE DIPROPIONATE

CREAM;TOPICAL

ALCLOMETASONE DIPROPIONATE

AB
+ FOUGERA PHARMS
AB
GLENMARK GENERICS
AB
TARO
OINTMENT;TOPICAL

ALCLOMETASONE DIPROPIONATE

AB
+ FOUGERA PHARMS
AB
GLENMARK GENERICS

A077559
A076749
A202496
A076724
A077063

001
001
001
001
001

Dec
Dec
Oct
Dec
Dec

31,
31,
01,
31,
31,

2007

2007

2012

2007

2007

N020950 001 Mar 21, 2001

N021747 001 Oct 07, 2011

0.25%

N022134 001 Jul 28, 2010

0.05%
0.05%
0.05%

A076973 001 Jul 12, 2005

A079061 001 Jun 23, 2009

A076587 001 Sep 15, 2005

0.05%
0.05%

A076884 001 Jul 18, 2005

A079227 001 Jul 30, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-10(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ALCLOMETASONE DIPROPIONATE

OINTMENT;TOPICAL

ALCLOMETASONE DIPROPIONATE

AB
TARO

0.05%

A076730 001 Jul 29, 2004

ALECTINIB HYDROCHLORIDE

CAPSULE;ORAL

ALECENSA

+ HOFFMANN-LA ROCHE

EQ 150MG BASE

N208434 001 Dec 11, 2015

EQ 70MG BASE/75ML

A090520 001 Feb 25, 2013

EQ 70MG BASE/75ML

N021575 001 Sep 17, 2003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A077982
A077982
A077982
A077982
A090124
A090124
A090124
A090258
A090258
A090258
A090258
A090557
A090557
A090557
A090557
A076768
A076768
A076768
A076768
A076768
A079109
A079109
A079049
A079049
A076584
A076584
A076584
A076584
A090022
A090022
A090022
A090022
A075710
A075710
A075710
A075710
A075710
A076984
A076984
A076984

ALENDRONATE SODIUM

SOLUTION;ORAL

ALENDRONATE SODIUM

AA
ROXANE

FOSAMAX

AA
+ MERCK

TABLET;ORAL

ALENDRONATE SODIUM

AB
APOTEX

AB

AB

AB

AB
AUROBINDO PHARMA

AB

AB

AB
AUSTARPHARMA LLC

AB

AB

AB

AB
CADISTA PHARMS

AB

AB

AB

AB
CIPLA LTD

AB

AB

AB

AB

AB
DR REDDYS LABS LTD

AB

AB

AB

AB
MYLAN

AB

AB

AB

AB
SUN PHARMA GLOBAL

AB

AB

AB

AB
TEVA PHARMS

AB

AB

AB

AB

AB
WATSON LABS

AB

AB

FOSAMAX

AB
+ MERCK AND CO INC

TABLET, EFFERVESCENT;ORAL

BINOSTO

+ MISSION PHARMA

5MG BASE

10MG BASE

35MG BASE

70MG BASE

10MG BASE

35MG BASE

70MG BASE

5MG BASE

10MG BASE

35MG BASE

70MG BASE

5MG BASE

10MG BASE

35MG BASE

70MG BASE

5MG BASE

10MG BASE

35MG BASE

40MG BASE

70MG BASE

5MG BASE

10MG BASE

35MG BASE

70MG BASE

5MG BASE

10MG BASE

35MG BASE

70MG BASE

5MG BASE

10MG BASE

35MG BASE

70MG BASE

5MG BASE

10MG BASE

35MG BASE

40MG BASE

70MG BASE

35MG BASE

40MG BASE

70MG BASE

001
002
003
004
001
002
003
001
002
003
004
001
002
003
004
001
002
003
004
005
001
002
001
002
001
002
003
004
001
002
003
004
001
002
003
004
005
001
002
003

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Feb
Feb
Feb
Feb
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Feb
Feb
Feb
Feb
Feb
Aug
Aug
Aug

04,
04,
04,
04,
04,
04,
04,
24,
24,
24,
24,
18,
18,
18,
18,
04,
04,
04,
04,
04,
04,
04,
04,
04,
04,
04,
04,
04,
10,
10,
10,
10,
06,
06,
06,
06,
06,
04,
04,
04,

2008

2008

2008

2008

2008

2008

2008

2009

2009

2009

2009

2010

2010

2010

2010

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

EQ 70MG BASE

N020560 005 Oct 20, 2000

EQ 70MG BASE

N202344 001 Mar 12, 2012

ALENDRONATE SODIUM; CHOLECALCIFEROL

TABLET;ORAL
FOSAMAX PLUS D
MERCK
EQ 70MG BASE;2,800 IU
+
EQ 70MG BASE;5,600 IU

N021762 001 Apr 07, 2005

N021762 002 Apr 26, 2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-11(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ALFENTANIL HYDROCHLORIDE

INJECTABLE;INJECTION

ALFENTA
AP
+ AKORN
ALFENTANIL
AP
HOSPIRA

EQ 0.5MG BASE/ML

N019353 001 Dec 29, 1986

EQ 0.5MG BASE/ML

A075221 001 Oct 28, 1999

ALFUZOSIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ALFUZOSIN HYDROCHLORIDE

AB
APOTEX INC

10MG

AB
AUROBINDO PHARMA LTD
10MG

AB
INVAGEN PHARMS

10MG

AB
MYLAN

10MG

AB
SUN PHARMA GLOBAL

10MG

AB
TEVA PHARMS

10MG

AB
TORRENT PHARMS

10MG

UROXATRAL

AB
+ CONCORDIA PHARMS INC
10MG

ALISKIREN HEMIFUMARATE

TABLET;ORAL

TEKTURNA

NOVARTIS

+

EQ 150MG BASE

EQ 300MG BASE

A079013
A079060
A090284
A079014
A079057
A079056
A079054

001
001
001
001
001
001
001

Jul
Aug
Jan
Jul
Jul
Jul
Jul

18,
30,
17,
18,
18,
18,
18,

2011

2012

2012

2011

2011

2011

2011

N021287 001 Jun 12, 2003

N021985 001 Mar 05, 2007

N021985 002 Mar 05, 2007

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

TEKTURNA HCT

NOVARTIS

EQ 150MG BASE;12.5MG

EQ 150MG BASE;25MG

+

EQ 300MG BASE;12.5MG

+

EQ 300MG BASE;25MG

N022107
N022107
N022107
N022107

ALITRETINOIN

GEL;TOPICAL

PANRETIN

+ EISAI INC

EQ 0.1% BASE

N020886 001 Feb 02, 1999

100MG

300MG

100MG

300MG

100MG

300MG

100MG

300MG

100MG

300MG

100MG

300MG

100MG

300MG

100MG

300MG

100MG

300MG

A203154
A203154
A077353
A077353
A090637
A090637
A071449
A071450
A018659
A018659
A078253
A078253
A078390
A078390
A075798
A075798
N018832
N018877

100MG

300MG

A071586 001 Apr 02, 1987

A071587 001 Apr 02, 1987

100MG

300MG

N016084 001

N016084 002

EQ 500MG BASE/VIAL

A076870 001 Aug 26, 2004

EQ 500MG BASE/VIAL

N020298 001 May 17, 1996

ALLOPURINOL

TABLET;ORAL

ALLOPURINOL
AB
ACCORD HLTHCARE
AB
AB
APOTEX INC
AB
AB
IPCA LABS LTD
AB
AB
MUTUAL PHARM
AB
AB
MYLAN
AB
AB
NORTHSTAR HLTHCARE
AB
AB
SUN PHARM INDS INC
AB
AB
VINTAGE PHARMS
AB
AB
WATSON LABS
AB
LOPURIN
AB
DR REDDYS LA
AB
ZYLOPRIM
AB
PROMETHEUS LABS
AB
+
ALLOPURINOL SODIUM

INJECTABLE;INJECTION

ALLOPURINOL SODIUM

AP
EUROHLTH INTL SARL

ALOPRIM

AP
+ MYLAN INSTITUTIONAL

001
002
003
004

001
002
001
002
001
002
001
001
001
002
001
002
001
002
001
002
002
001

Jan
Jan
Jan
Jan

May
May
Sep
Sep
Mar
Mar
Jan
Jan
Oct
Oct
Sep
Sep
Aug
Aug
Jun
Jun
Sep
Sep

18,
18,
18,
18,

06,
06,
08,
08,
16,
16,
09,
09,
24,
24,
11,
11,
30,
30,
27,
27,
28,
28,

2008

2008

2008

2008

2013

2013

2005

2005

2011

2011

1987

1987

1986

1986

2007

2007

2007

2007

2003

2003

1984

1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-12(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ALMOTRIPTAN MALATE

TABLET;ORAL

ALMOTRIPTAN MALATE

AB
MYLAN PHARMS INC
AB
AB
TEVA PHARMS USA
AB
AXERT

AB
JANSSEN PHARMS
AB
+
ALOGLIPTIN BENZOATE

TABLET;ORAL

NESINA

TAKEDA PHARMS USA
+

EQ
EQ
EQ
EQ

6.25MG
12.5MG
6.25MG
12.5MG

BASE
BASE
BASE
BASE

A205171
A205171
A078027
A078027

001
002
001
002

Nov
Nov
Jul
Jul

09,
09,
07,
07,

2015

2015

2015

2015

EQ 6.25MG BASE
EQ 12.5MG BASE

N021001 001 May 07, 2001

N021001 002 May 07, 2001

EQ 6.25MG BASE
EQ 12.5MG BASE
EQ 25MG BASE

N022271 001 Jan 25, 2013

N022271 002 Jan 25, 2013
N022271 003 Jan 25, 2013

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

KAZANO

TAKEDA PHARMS USA
EQ 12.5MG BASE;500MG
+
EQ 12.5MG BASE;1GM

N203414 001 Jan 25, 2013

N203414 002 Jan 25, 2013

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

OSENI

TAKEDA PHARMS USA
EQ 12.5MG BASE;EQ 15MG BASE
EQ 12.5MG BASE;EQ 30MG BASE
EQ 12.5MG BASE;EQ 45MG BASE
EQ 25MG BASE;EQ 15MG BASE
EQ 25MG BASE;EQ 30MG BASE
+
EQ 25MG BASE;EQ 45MG BASE

N022426
N022426
N022426
N022426
N022426
N022426

ALOSETRON HYDROCHLORIDE

TABLET;ORAL

ALOSETRON HYDROCHLORIDE

AB
ROXANE
AB
LOTRONEX

AB
PROMETHEUS LABS
AB
+

004
005
006
001
002
003

Jan
Jan
Jan
Jan
Jan
Jan

25,
25,
25,
25,
25,
25,

2013

2013

2013

2013

2013

2013

EQ 0.5MG BASE
EQ 1MG BASE

A200652 001 May 04, 2015

A200652 002 May 04, 2015

EQ 0.5MG BASE
EQ 1MG BASE

N021107 002 Dec 23, 2003

N021107 001 Feb 09, 2000

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL;

FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE

HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

INJECTABLE;INJECTION

INFUVITE ADULT

+ SANDOZ
2 IU/ML;40MG/ML;12MCG/ML;40
N021163 001 May 18, 2000

IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1

.2MG/ML;0.72MG/ML;1.2MG/ML;660

IU/ML;0.03MG/ML

INJECTABLE;IV (INFUSION)

INFUVITE ADULT

+ SANDOZ
2 IU/ML;40MG/ML;12MCG/ML;40
N021559 001 Jun 16, 2003

IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1

.2MG/ML;0.72MG/ML;1.2MG/ML;660

IU/ML;30MCG/ML

ALPRAZOLAM

CONCENTRATE;ORAL

ALPRAZOLAM

+ ROXANE
TABLET;ORAL

ALPRAZOLAM

AB
ACTAVIS ELIZABETH
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB

1MG/ML

A074312 001 Oct 31, 1993

0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG

A074342
A074342
A074342
A074342
A077741
A077741
A077741
A077741
A203346
A203346
A203346

001
002
003
004
001
002
003
004
001
002
003

Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
Jul
Jul
Jul

31,
31,
31,
31,
19,
19,
19,
19,
31,
31,
31,

1993

1993

1993

1993

2007

2007

2007

2007

2015

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-13(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ALPRAZOLAM

TABLET;ORAL

ALPRAZOLAM

AB
2MG
AB
DAVA INTL INC
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
MYLAN
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
MYLAN PHARMS INC
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
NATCO PHARMA LTD
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
SANDOZ
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
SUN PHARMA GLOBAL
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
VINTAGE
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
VINTAGE PHARMS
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
XANAX

AB
PHARMACIA AND UPJOHN
0.25MG
AB
0.5MG
AB
+
1MG
AB
2MG
TABLET, EXTENDED RELEASE;ORAL

ALPRAZOLAM

AB
ACTAVIS ELIZABETH
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
ACTAVIS LABS FL INC
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
AMNEAL PHARMS NY
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
ANCHEN PHARMS
0.5MG
AB
1MG
AB
2MG
AB
3MG
0.5MG
AB
ANI PHARMS INC
AB
1MG
AB
2MG
AB
3MG
AB
APOTEX INC
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
AUROBINDO PHARMA USA
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
COREPHARMA
0.5MG

A203346
A074174
A074174
A074174
A074174
A074215
A074215
A074215
A074215
A074046
A074046
A074046
A074046
A200739
A200739
A200739
A200739
A074112
A074112
A074112
A074909
A090082
A090082
A090082
A090082
A078491
A078491
A078491
A078491
A090248
A090248
A090248
A090248

004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
001
002
003
004
001
002
003
004
001
002
003
004

N018276
N018276
N018276
N018276

001

002

003

004 Nov 27, 1985

A078056
A078056
A078056
A078056
A077198
A077198
A077198
A077198
A078387
A078387
A078387
A078387
A078469
A078469
A078469
A078469
A077725
A077725
A077725
A077725
A078449
A078449
A078449
A078449
A090871
A090871
A090871
A090871
A077996

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
004
003
001
004
002
003
001
002
003
004
001

Jul
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
Oct
Oct
Oct
May
Apr
Apr
Apr
Apr
Dec
Dec
Dec
Mar
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Dec
Sep
Sep
Sep
Sep

Feb
Feb
Feb
Feb
May
May
May
May
May
May
May
May
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Nov
Dec
Nov
Nov
Jun
Jun
Jun
Jun
Jan

31,
19,
19,
19,
19,
27,
27,
27,
27,
19,
19,
19,
07,
15,
15,
15,
15,
29,
29,
29,
25,
17,
17,
17,
17,
25,
25,
25,
12,
17,
17,
17,
17,

13,
13,
13,
13,
13,
13,
13,
13,
30,
30,
30,
30,
29,
29,
29,
29,
31,
31,
31,
31,
12,
23,
12,
12,
07,
07,
07,
07,
31,

2015

1993

1993

1993

1993

1994

1994

1994

1994

1993

1993

1993

1997

2015

2015

2015

2015

1995

1995

1995

1998

2010

2010

2010

2010

2008

2008

2008

2008

2010

2010

2010

2010

2007

2007

2007

2007

2010

2010

2010

2010

2008

2008

2008

2008

2011

2011

2011

2011

2006

2006

2006

2006

2008

2015

2008

2008

2011

2011

2011

2011

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-14(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ALPRAZOLAM

TABLET, EXTENDED RELEASE;ORAL

ALPRAZOLAM

AB
1MG
AB
2MG
AB
3MG
AB
HERITAGE PHARMS INC
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
IMPAX LABS
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
MYLAN
0.5MG
AB
1MG
AB
2MG
AB
3MG
XANAX XR

AB
PHARMACIA AND UPJOHN
0.5MG
AB
1MG
AB
2MG
AB
+
3MG
TABLET, ORALLY DISINTEGRATING;ORAL

ALPRAZOLAM

AB
ACTAVIS ELIZABETH
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
PAR PHARM
0.25MG
AB
0.5MG
AB
+
1MG
AB
2MG
ALPROSTADIL

INJECTABLE;INJECTION

ALPROSTADIL

AP
EUROHLTH INTL SARL
AP
TEVA PHARMS USA
CAVERJECT

AP
PHARMACIA AND UPJOHN
AP
+
AP
+
EDEX

AP
AUXILIUM PHARMS LLC
AP
AP
+
PROSTIN VR PEDIATRIC

AP
+ PHARMACIA AND UPJOHN
CAVERJECT

PHARMACIA AND UPJOHN
CAVERJECT IMPULSE

PHARMACIA AND UPJOHN
EDEX

+ AUXILIUM PHARMS LLC
+
+
SUPPOSITORY;URETHRAL

MUSE

MEDA PHARMS

+
ALTRETAMINE

CAPSULE;ORAL

HEXALEN

+ EISAI INC

A077996
A077996
A077996
A078489
A078489
A078489
A078489
A077968
A077968
A077968
A077968
A077391
A077391
A077391
A077391

002
003
004
001
002
003
004
004
003
002
001
002
003
004
001

Jan
Jan
Jan
Oct
Oct
Oct
Oct
May
May
May
May
Jan
Jan
Jan
Jan

31,
31,
31,
17,
17,
17,
17,
24,
24,
24,
24,
26,
26,
26,
26,

2007

2007

2007

2008

2008

2008

2008

2007

2007

2007

2007

2006

2006

2006

2006

N021434
N021434
N021434
N021434

001
002
003
004

Jan
Jan
Jan
Jan

17,
17,
17,
17,

2003

2003

2003

2003

A078561
A078561
A078561
A078561
A078088
A078088
A078088
A078088

001
002
003
004
001
002
003
004

Mar
Mar
Mar
Mar
Jan
Jan
Jan
Jan

16,
16,
16,
16,
09,
09,
09,
09,

2010

2010

2010

2010

2009

2009

2009

2009

0.5MG/ML
0.5MG/ML

A074815 001 Jan 20, 1998

A075196 001 Apr 30, 1999

0.01MG/VIAL
0.02MG/VIAL
0.04MG/VIAL

N020379 001 Jul 06, 1995

N020379 002 Jul 06, 1995

N020379 004 May 19, 1997

0.01MG/VIAL
0.02MG/VIAL
0.04MG/VIAL

N020649 002 Jun 12, 1997

N020649 003 Jun 12, 1997

N020649 004 Jun 12, 1997

0.5MG/ML

N018484 001

0.005MG/VIAL

N020379 003 Jun 27, 1996

0.01MG/VIAL
0.02MG/VIAL

N021212 001 Jun 11, 2002

N021212 002 Jun 11, 2002

0.01MG/VIAL
0.02MG/VIAL
0.04MG/VIAL

N020649 005 Jul 30, 1998

N020649 006 Jul 30, 1998

N020649 007 Jul 30, 1998

0.125MG
0.25MG
0.5MG
1MG

N020700
N020700
N020700
N020700

50MG

N019926 001 Dec 26, 1990

001
002
003
004

Nov
Nov
Nov
Nov

19,
19,
19,
19,

1996

1996

1996

1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-15(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ALVIMOPAN

CAPSULE;ORAL

ENTEREG

+ CUBIST PHARMS
AMANTADINE HYDROCHLORIDE

CAPSULE;ORAL

AMANTADINE HYDROCHLORIDE

AB
BANNER LIFE SCIENCES
AB
+ SANDOZ
AB
USL PHARMA
SYRUP;ORAL

AMANTADINE HYDROCHLORIDE

AA
+ CAROLINA MEDCL
AA
+ HI TECH PHARMA
AA
+ MIKART
AA
+ PHARM ASSOC
AA
+ WOCKHARDT
TABLET;ORAL

AMANTADINE HYDROCHLORIDE

+ USL PHARMA
AMBRISENTAN

TABLET;ORAL

LETAIRIS

GILEAD
+
AMCINONIDE

CREAM;TOPICAL

AMCINONIDE

AB
+ FOUGERA PHARMS
AB
TARO PHARM INDS
LOTION;TOPICAL

AMCINONIDE

+ FOUGERA PHARMS
OINTMENT;TOPICAL

AMCINONIDE

AB
+ FOUGERA PHARMS
AB
TARO PHARM INDS

12MG

N021775 001 May 20, 2008

100MG
100MG
100MG

A078720 001 May 29, 2008

A071293 001 Feb 18, 1987

A070589 001 Aug 05, 1986

50MG/5ML
50MG/5ML
50MG/5ML
50MG/5ML
50MG/5ML

A075819
A074170
A074028
A074509
A075060

100MG

A076186 001 Dec 16, 2002

5MG
10MG

N022081 001 Jun 15, 2007

N022081 002 Jun 15, 2007

0.1%
0.1%

A076065 001 May 15, 2003

A076229 001 May 31, 2002

0.1%

A076329 001 Nov 06, 2002

0.1%
0.1%

A076096 001 Nov 19, 2002

A076367 001 Mar 19, 2003

001
001
001
001
001

Sep
Oct
Jun
Jul
Dec

11,
28,
28,
17,
24,

2002

1994

1993

1995

1998

AMIFOSTINE

INJECTABLE;INJECTION

AMIFOSTINE

AP
SUN PHARMA GLOBAL
ETHYOL

AP
+ CLINIGEN HLTHCARE

500MG/VIAL

A077126 001 Mar 14, 2008

500MG/VIAL

N020221 001 Dec 08, 1995

AMIKACIN SULFATE

INJECTABLE;INJECTION

AMIKACIN SULFATE

AP
EMCURE PHARMS LTD
AP
+ EUROHLTH INTL SARL
AP
+
AP
FRESENIUS KABI USA
AP
AP
TEVA PHARMS USA

EQ
EQ
EQ
EQ
EQ
EQ

A204040
A063313
A063315
A205605
A205604
A064045

AMILORIDE HYDROCHLORIDE

TABLET;ORAL

AMILORIDE HYDROCHLORIDE

AB
+ PAR PHARM
AB
SIGMAPHARM LABS LLC
AB
ZYDUS PHARMS USA INC
MIDAMOR

AB
PADDOCK LLC

250MG BASE/ML
50MG BASE/ML
250MG BASE/ML
50MG BASE/ML
250MG BASE/ML
250MG BASE/ML

001
001
001
001
001
002

Dec
Apr
Apr
Dec
Dec
Sep

12,
11,
11,
09,
09,
28,

2013

1994

1994

2015

2015

1993

5MG
5MG
5MG

A070346 001 Jan 22, 1986

A079133 001 Jan 30, 2009

A204180 001 Aug 07, 2015

5MG

N018200 001

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AB
BARR
EQ 5MG ANHYDROUS;50MG
AB
+ MYLAN
EQ 5MG ANHYDROUS;50MG

A071111 001 May 10, 1988

A073209 001 Oct 31, 1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-16(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMINO ACIDS
INJECTABLE;INJECTION
AMINO ACIDS
B BRAUN

15%(150GM/1000ML)
15%(300GM/2000ML)

AMINOSYN 10%
HOSPIRA
10% (10GM/100ML)
AMINOSYN 10% (PH6)
HOSPIRA
10% (10GM/100ML)
AMINOSYN 3.5%
HOSPIRA
3.5% (3.5GM/100ML)
AMINOSYN 5%
HOSPIRA
5% (5GM/100ML)
AMINOSYN 7%
HOSPIRA
7% (7GM/100ML)
AMINOSYN 7% (PH6)
HOSPIRA
7% (7GM/100ML)
AMINOSYN 8.5%
HOSPIRA
8.5% (8.5GM/100ML)
AMINOSYN 8.5% (PH6)
HOSPIRA
8.5% (8.5GM/100ML)
AMINOSYN II 10%
HOSPIRA
10% (10GM/100ML)
AMINOSYN II 10% IN PLASTIC CONTAINER
HOSPIRA
10% (10GM/100ML)
AMINOSYN II 15% IN PLASTIC CONTAINER
HOSPIRA
15% (15GM/100ML)
AMINOSYN II 7%
HOSPIRA
7% (7GM/100ML)
AMINOSYN II 8.5%
HOSPIRA
8.5% (8.5GM/100ML)
AMINOSYN-HBC 7%
HOSPIRA
7% (7GM/100ML)
AMINOSYN-HF 8%
HOSPIRA
8% (8GM/100ML)
AMINOSYN-PF 10%
HOSPIRA
10% (10GM/100ML)
AMINOSYN-PF 7%
HOSPIRA
7% (7GM/100ML)
AMINOSYN-RF 5.2%
HOSPIRA
5.2% (5.2GM/100ML)
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCARE
15% (15GM/100ML)
FREAMINE HBC 6.9%
B BRAUN
6.9% (6.9GM/100ML)
FREAMINE III 10%
B BRAUN
10% (10GM/100ML)
FREAMINE III 8.5%
B BRAUN
8.5% (8.5GM/100ML)
HEPATAMINE 8%
B BRAUN
8% (8GM/100ML)
NEPHRAMINE 5.4%
B BRAUN
5.4% (5.4GM/100ML)
PREMASOL 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE
10% (10GM/100ML)
PREMASOL 6% IN PLASTIC CONTAINER
BAXTER HLTHCARE
6% (6GM/100ML)
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
20% (20GM/100ML)
TRAVASOL 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE
10% (10MG/100ML)
TRAVASOL 5.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5.5% (5.5GM/100ML)
TRAVASOL 8.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
8.5% (8.5GM/100ML)
TROPHAMINE
+ B BRAUN
6% (6GM/100ML)
TROPHAMINE 10%
+ B BRAUN
10% (10GM/100ML)

A091112 001 Apr 13, 2012

A091112 002 Apr 13, 2012
N017673 003
N017673 008 Nov 18, 1985
N017789 004
N017673 001
N017673 002
N017673 006 Nov 18, 1985
N017673 004
N017673 007 Nov 18, 1985
N019438 005 Apr 03, 1986
N020015 001 Dec 19, 1991
N020041 001 Dec 19, 1991
N019438 003 Apr 03, 1986
N019438 004 Apr 03, 1986
N019374 001 Jul 12, 1985
A020345 001 Apr 04, 1996
N019492 002 Oct 17, 1986
N019398 001 Sep 06, 1985
N018429 001
A020512 001 Aug 30, 1996
N016822 006 May 17, 1983
N016822 005
N016822 004
N018676 001 Aug 03, 1982
N017766 001
A075880 002 Jun 19, 2003
A075880 001 Jun 19, 2003
N020849 001 Aug 26, 1998
N018931 003 Aug 23, 1984
N018931 001 Aug 23, 1984
N018931 002 Aug 23, 1984
N019018 001 Jul 20, 1984
N019018 003 Sep 07, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

3-17(of 388)

AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE;

SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

PROCALAMINE

B BRAUN
3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG
N018582 001 May 08, 1982

/100ML;150MG/100ML;200MG/100ML;120MG/10

0ML

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM

ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
2.75%;33MG/100ML;10GM/100ML;51MG/100ML;
N020678 002 Mar 26, 1997

261MG/100ML;217MG/100ML;112MG/100ML

CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
2.75%;33MG/100ML;25GM/100ML;51MG/100ML;
N020678 005 Mar 26, 1997

261MG/100ML;217MG/100ML;112MG/100ML

CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
2.75%;33MG/100ML;5GM/100ML;51MG/100ML;2
N020678 001 Mar 26, 1997

61MG/100ML;217MG/100ML;112MG/100ML

CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
4.25%;33MG/100ML;10GM/100ML;51MG/100ML;
N020678 009 Mar 26, 1997

261MG/100ML;297MG/100ML;77MG/100ML

CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
4.25%;33MG/100ML;20GM/100ML;51MG/100ML;
N020678 011 Mar 26, 1997

261MG/100ML;297MG/100ML;77MG/100ML

CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
4.25%;33MG/100ML;25GM/100ML;51MG/100ML;
N020678 012 Mar 26, 1997

261MG/100ML;297MG/100ML;77MG/100ML

CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
4.25%;33MG/100ML;5GM/100ML;51MG/100ML;2
N020678 008 Mar 26, 1997

61MG/100ML;297MG/100ML;77MG/100ML

CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
5%;33MG/100ML;10GM/100ML;51MG/100ML;261
N020678 016 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
5%;33MG/100ML;15GM/100ML;51MG/100ML;261
N020678 017 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
5%;33MG/100ML;20GM/100ML;51MG/100ML;261
N020678 018 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
5%;33MG/100ML;25GM/100ML;51MG/100ML;261
N020678 019 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
5%;33MG/100ML;35GM/100ML;51MG/100ML;261
N020678 021 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE;

SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

EMULSION;IV (INFUSION)

KABIVEN IN PLASTIC CONTAINER

FRESENIUS KABI USA
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;
N200656 004 Aug 25, 2014

174MG/100ML;239MG/100ML

;147MG/100ML;3.9GM/100ML (1026ML)

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;
N200656 005 Aug 25, 2014

174MG/100ML;239MG/100ML;147MG/100ML;3.9

GM/100ML (1540ML)

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;
N200656 006 Aug 25, 2014

174MG/100ML;239MG/100ML;147MG/100ML;3.9

GM/100ML (2053ML)

+
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;
N200656 007 Aug 25, 2014

174MG/100ML;239MG/100ML;147MG/100ML;3.9

GM/100ML (2566ML)

PERIKABIVEN IN PLASTIC CONTAINER

FRESENIUS KABI USA
2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;
N200656 001 Aug 25, 2014

124MG/100ML;170MG/100ML;105MG/100ML;3.5

GM/100ML (1440ML)

2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;
N200656 002 Aug 25, 2014

124MG/100ML;170MG/100ML;105MG/100ML;3.5

GM/100ML (1920ML)

2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;
N200656 003 Aug 25, 2014

124MG/100ML;170MG/100ML

;105MG/100ML;3.5GM/100ML (2400ML)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-18(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMINO ACIDS; DEXTROSE

INJECTABLE;INJECTION

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;10GM/100ML

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;25GM/100ML

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;5GM/100ML

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;10GM/100ML

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;20GM/100ML

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;25GM/100ML

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;5GM/100ML

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5%;10GM/100ML

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5%;15GM/100ML

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5%;20GM/100ML

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5%;25GM/100ML

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5%;35GM/100ML

N020734 002
Sep 29, 1997

N020734 005
Sep 29, 1997

N020734 001
Sep 29, 1997

N020734 008
Sep 29, 1997

N020734 010
Sep 29, 1997

N020734 011
Sep 29, 1997

N020734 007
Sep 29, 1997

N020734 014
Sep 29, 1997

N020734 015
Sep 29, 1997

N020734 016
Sep 29, 1997

N020734 017
Sep 29, 1997

N020734 018
Sep 29, 1997

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM

ACETATE

INJECTABLE;INJECTION

FREAMINE III 8.5% W/ ELECTROLYTES

B BRAUN
8.5%;110MG/100ML;230MG/100ML;10MG/100ML
N016822 007 Jul 01, 1988

;440MG/100ML;690MG/100ML

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN 3.5% M

HOSPIRA
3.5%;21MG/100ML;40MG/100ML;128MG/100ML;
N017789 003

234MG/100ML

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

CHLORIDE

INJECTABLE;INJECTION

FREAMINE III 3% W/ ELECTROLYTES

B BRAUN
3%;54MG/100ML;40MG/100ML;150MG/100ML;20
N016822 003

0MG/100ML;120MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN II 10% W/ ELECTROLYTES

HOSPIRA
10%;102MG/100ML;45MG/100ML;522MG/100ML;
N019437 004 Apr 03, 1986

410MG/100ML

AMINOSYN II 8.5% W/ ELECTROLYTES

HOSPIRA
8.5%;102MG/100ML;45MG/100ML;522MG/100ML
N019437 005 Apr 03, 1986

;410MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN 7% W/ ELECTROLYTES

HOSPIRA
7%;102MG/100ML;522MG/100ML;410MG/100ML

N017789 002

AMINOSYN 8.5% W/ ELECTROLYTES

HOSPIRA
8.5%;102MG/100ML;522MG/100ML;410MG/100M
N017673 005

L
AMINOCAPROIC ACID
INJECTABLE;INJECTION
AMINOCAPROIC ACID
AP
LUITPOLD
250MG/ML
AMINOCAPROIC ACID IN PLASTIC CONTAINER

AP
+ HOSPIRA

250MG/ML

SYRUP;ORAL

AMICAR
AA
+ CLOVER PHARMS
1.25GM/5ML

AMINOCAPROIC ACID
AA
VERSAPHARM INC
1.25GM/5ML

A071192 001 Dec 01, 1987

A070010 001 Mar 09, 1987

N015230 002

A074759 001 Sep 02, 1998

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-19(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMINOCAPROIC ACID

TABLET;ORAL

AMICAR

AB
CLOVER PHARMS
AMINOCAPROIC

AB
VERSAPHARM INC
AMICAR

+ CLOVER PHARMS

500MG

N015197 001

500MG

A075602 001 May 24, 2001

1GM

N015197 002 Jun 24, 2004

AMINOLEVULINIC ACID HYDROCHLORIDE

SOLUTION;TOPICAL

LEVULAN

+ DUSA
20%

N020965 001 Dec 03, 1999

AMINOPHYLLINE

INJECTABLE;INJECTION

AMINOPHYLLINE

AP
+ HOSPIRA
AP
LUITPOLD

A087242 001 Oct 26, 1983

A087600 001

25MG/ML
25MG/ML

AMINOSALICYLIC ACID

GRANULE, DELAYED RELEASE;ORAL

PASER

+ JACOBUS
4GM/PACKET
AMIODARONE HYDROCHLORIDE

INJECTABLE;INJECTION

AMIODARONE HYDROCHLORIDE

AP
+ AKORN
AP
+ FRESENIUS KABI USA
AP
+ GLAND PHARMA LTD
AP
HIKMA FARMACEUTICA
AP
+ HOSPIRA
AP
HOSPIRA INC
AP
AP
+ MYLAN INSTITUTIONAL
AP
WOCKHARDT
AP
NEXTERONE

AP
BAXTER HLTHCARE
+
+
TABLET;ORAL

AMIODARONE HYDROCHLORIDE

AB
APOTEX CORP
AB
MURTY PHARMS
AB
AB
MYLAN
AB
SANDOZ
AB
AB
SWAN PHARMS LLC
AB
TARO
AB
AB
AB
TEVA PHARMS
AB
ZYDUS PHARMS USA INC
CORDARONE

AB
+ WYETH PHARMS INC
PACERONE

AB
UPSHER SMITH
AB
AMIODARONE HYDROCHLORIDE

TARO
AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE
AB
ACCORD HLTHCARE
AB
AB
AB
AB
AB
AB
MUTUAL PHARM
AB

A074346 001 Jun 30, 1994

50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML

A076232
A075761
A077161
A077234
A075955
A203884
A203885
A076217
A077610
A077834

001
001
001
001
001
001
001
001
001
001

50MG/ML
150MG/100ML (1.5MG/ML)
360MG/200ML (1.8MG/ML)

N022325 001 Dec 24, 2008

N022325 002 Nov 16, 2010

N022325 003 Nov 16, 2010

200MG
200MG
400MG
200MG
200MG
400MG
200MG
100MG
200MG
400MG
200MG
200MG

A078578
A077069
A077069
A075188
A075315
A075315
A075389
A075424
A075424
A076362
A074739
A079029

200MG

N018972 001 Dec 24, 1985

100MG
200MG

A075135 002 Apr 12, 2005

A075135 001 Apr 30, 1998

300MG

A076362 002 Dec 02, 2003

10MG

25MG

50MG

75MG

100MG

150MG

10MG

25MG

A202446
A202446
A202446
A202446
A202446
A202446
A089399
A089399

001
001
002
001
001
002
001
002
001
001
001
001

001
002
003
004
005
006
002
001

Jul
Oct
Apr
Feb
Oct
Nov
Nov
Oct
Oct
Oct

Nov
Apr
Apr
Feb
Dec
Jun
Jan
Dec
Mar
Nov
Nov
Sep

Jun
Jun
Jun
Jun
Jun
Jun
Jul
Jul

05,
15,
20,
25,
18,
25,
25,
15,
30,
30,

06,
08,
08,
24,
23,
30,
25,
18,
30,
29,
30,
16,

04,
04,
04,
04,
04,
04,
14,
14,

2006

2002

2005

2008

2002

2013

2013

2002

2008

2008

2008

2005

2005

1999

1998

2000

2001

2002

2001

2002

1998

2008

2014

2014

2014

2014

2014

2014

1987

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-20(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE

AB
50MG

AB
75MG

AB
100MG

AB
150MG

AB
MYLAN
10MG

AB
25MG

AB
50MG

AB
75MG

AB
100MG

AB
150MG

AB
SANDOZ
10MG

AB
+
25MG

AB
50MG

AB
75MG

AB
100MG

AB
150MG

AB
SUN PHARM INDS INC
10MG

AB
25MG

AB
50MG

AB
75MG

AB
100MG

AB
150MG

AB
VINTAGE PHARMS
10MG

AB
25MG

AB
50MG

AB
75MG

AB
100MG

AB
150MG

A089399
A089399
A089399
A089399
A086009
A086009
A086009
A086009
A086009
A086009
A085969
A085966
A085968
A085971
A085967
A085970
A040816
A040816
A040816
A040816
A040816
A040816
A040218
A040218
A040218
A040218
A040218
A040218

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET;ORAL

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

MYLAN PHARMS INC
EQ 12.5MG BASE;5MG

+
EQ 25MG BASE;10MG

A071297 002 Dec 10, 1986

A071297 001 Dec 10, 1986

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET;ORAL

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

MYLAN

10MG;2MG

10MG;4MG

+

25MG;2MG

+

25MG;4MG

+

50MG;4MG

A071443
A071443
A071443
A071443
A071443

002
003
004
005
001

Nov
Nov
Nov
Nov
Nov

10,
10,
10,
10,
10,

1988

1988

1988

1988

1988

AMLODIPINE BESYLATE

TABLET;ORAL

AMLODIPINE BESYLATE
AB
ACCORD HLTHCARE
AB
AB
AB
ALKEM
AB
AB
AB
AMNEAL PHARMS NY
AB
AB
AB
APOTEX
AB
AB
AB
ASCENT PHARMS INC
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
CHINA RESOURCES
AB
AB
CIPLA LTD
AB
AB
AB
DR REDDYS LABS LTD

A202553
A202553
A202553
A078925
A078925
A078925
A078477
A078477
A078477
A076719
A076719
A076719
A206367
A206367
A206367
A078021
A078021
A078021
A090752
A090752
A077073
A077073
A077073
A076692

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
001
002
003
001

Apr
Apr
Apr
May
May
May
Jan
Jan
Jan
May
May
May
Dec
Dec
Dec
Jul
Jul
Jul
Apr
Apr
Sep
Sep
Sep
Jul

29,
29,
29,
04,
04,
04,
16,
16,
16,
23,
23,
23,
10,
10,
10,
17,
17,
17,
15,
15,
26,
26,
26,
20,

2013

2013

2013

2009

2009

2009

2008

2008

2008

2007

2007

2007

2015

2015

2015

2007

2007

2007

2011

2011

2007

2007

2007

2007

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2.5MG BASE

5MG BASE

10MG BASE

2.5MG BASE

5MG BASE

10MG BASE

2.5MG BASE

5MG BASE

10MG BASE

2.5MG BASE

5MG BASE

10MG BASE

2.5MG BASE

5MG BASE

10MG BASE

2.5MG BASE

5MG BASE

10MG BASE

5MG BASE

10MG BASE

2.5MG BASE

5MG BASE

10MG BASE

2.5MG BASE

003
004
005
006
002

003

001

004

005

006

001

001

001

001

001

001

002
001
003
004
005
006
001
002
003
004
005
006

Jul
Jul
Jul
Jul

14,
14,
14,
14,

1987

1987

1987

1987

Jun
Jun
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
27,
27,
27,
11,
11,
11,
11,
11,
11,

2008

2008

2008

2008

2008

2008

1997

1997

1997

1997

1997

1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-21(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMLODIPINE BESYLATE

TABLET;ORAL

AMLODIPINE BESYLATE

AB
AB
AB
EPIC PHARMA LLC
AB
AB
AB
HIKMA PHARMS
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
LUPIN
AB
AB
AB
MACLEODS PHARMS LTD
AB
AB
MYLAN
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
ORCHID HLTHCARE
AB
AB
AB
ROXANE
AB
AB
AB
SOVEREIGN PHARMS
AB
AB
AB
SUN PHARM INDS INC
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
TEVA
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
UNICHEM LABS LTD
AB
AB
AB
UPSHER SMITH
AB
AB
AB
VINTAGE
AB
AB
AB
VIVIMED LABS
AB
AB
AB
WATSON LABS
AB
AB
AB
WOCKHARDT
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
NORVASC

AB
PFIZER
AB
AB
+

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE

EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE

A076692
A076692
A078552
A078552
A078552
A077771
A077771
A077771
A077955
A077955
A077955
A078043
A078043
A078043
A201380
A201380
A076418
A076418
A076418
A078224
A078224
A078224
A078453
A078453
A078453
A077262
A077262
A077262
A204900
A204900
A204900
A078231
A078231
A078231
A077974
A077974
A077974
A076846
A076846
A076846
A078573
A078573
A078573
A203245
A203245
A203245
A077759
A077759
A077759
A078414
A078414
A078414
A077516
A077516
A077516
A077671
A077671
A077671
A078500
A078500
A078500
A078226
A078226
A078226

002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jul
Jul
Apr
Apr
Apr
Apr
Apr
Apr
Aug
Aug
Aug
Jul
Jul
Jul
Apr
Apr
Oct
Oct
Oct
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Nov
Nov
Nov
Jul
Jul
Jul
Jun
Jun
Jun
Sep
Sep
Sep
Oct
Oct
Oct
Jul
Jul
Jul
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Jul
Jul
Jul

20,
20,
08,
08,
08,
12,
12,
12,
28,
28,
28,
12,
12,
12,
13,
13,
03,
03,
03,
27,
27,
27,
02,
02,
02,
09,
09,
09,
23,
23,
23,
30,
30,
30,
09,
09,
09,
28,
28,
28,
22,
22,
22,
21,
21,
21,
09,
09,
09,
07,
07,
07,
11,
11,
11,
19,
19,
19,
06,
06,
06,
09,
09,
09,

2007

2007

2009

2009

2009

2011

2011

2011

2007

2007

2007

2007

2007

2007

2012

2012

2005

2005

2005

2008

2008

2008

2009

2009

2009

2007

2007

2007

2015

2015

2015

2007

2007

2007

2007

2007

2007

2007

2007

2007

2008

2008

2008

2013

2013

2013

2007

2007

2007

2010

2010

2010

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

N019787 001 Jul 31, 1992

N019787 002 Jul 31, 1992

N019787 003 Jul 31, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-22(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

TABLET;ORAL

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

AB
DR REDDYS LABS LTD

EQ 2.5MG BASE;EQ 10MG BASE

AB

EQ 2.5MG BASE;EQ 20MG BASE

AB

EQ 2.5MG BASE;EQ 40MG BASE

AB

EQ 5MG BASE;EQ 10MG BASE

AB

EQ 5MG BASE;EQ 20MG BASE

AB

EQ 5MG BASE;EQ 40MG BASE

AB

EQ 5MG BASE;EQ 80MG BASE

AB

EQ 10MG BASE;EQ 10MG BASE

AB

EQ 10MG BASE;EQ 20MG BASE

AB

EQ 10MG BASE;EQ 40MG BASE

AB

EQ 10MG BASE;EQ 80MG BASE

AB
MYLAN PHARMS INC

EQ 2.5MG BASE;EQ 10MG BASE

AB

EQ 2.5MG BASE;EQ 20MG BASE

AB

EQ 2.5MG BASE;EQ 40MG BASE

AB

EQ 5MG BASE;EQ 10MG BASE

AB

EQ 5MG BASE;EQ 20MG BASE

AB

EQ 5MG BASE;EQ 40MG BASE

AB

EQ 5MG BASE;EQ 80MG BASE

AB

EQ 10MG BASE;EQ 10MG BASE

AB

EQ 10MG BASE;EQ 20MG BASE

AB

EQ 10MG BASE;EQ 40MG BASE

AB

EQ 10MG BASE;EQ 80MG BASE

CADUET

AB
PFIZER

EQ 2.5MG BASE;EQ 10MG BASE

AB

EQ 2.5MG BASE;EQ 20MG BASE

AB

EQ 2.5MG BASE;EQ 40MG BASE

AB

EQ 5MG BASE;EQ 10MG BASE

AB

EQ 5MG BASE;EQ 20MG BASE

AB

EQ 5MG BASE;EQ 40MG BASE

AB

EQ 5MG BASE;EQ 80MG BASE

AB

EQ 10MG BASE;EQ 10MG BASE

AB

EQ 10MG BASE;EQ 20MG BASE

AB

EQ 10MG BASE;EQ 40MG BASE

AB
+

EQ 10MG BASE;EQ 80MG BASE

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

CAPSULE;ORAL

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

AB
APOTEX INC

EQ 2.5MG BASE;10MG

AB

EQ 5MG BASE;10MG

AB

EQ 5MG BASE;20MG

AB

EQ 5MG BASE;40MG

AB

EQ 10MG BASE;20MG

AB

EQ 10MG BASE;40MG

AB
AUROBINDO PHARMA LTD
EQ 2.5MG BASE;10MG

AB

EQ 5MG BASE;10MG

AB

EQ 5MG BASE;20MG

AB

EQ 5MG BASE;40MG

AB

EQ 10MG BASE;20MG

AB

EQ 10MG BASE;40MG

AB
DR REDDYS LABS INC

EQ 2.5MG BASE;10MG

AB

EQ 5MG BASE;10MG

AB

EQ 5MG BASE;20MG

AB

EQ 5MG BASE;40MG

AB

EQ 10MG BASE;20MG

AB

EQ 10MG BASE;40MG

AB
LUPIN PHARMS

EQ 2.5MG BASE;10MG

AB

EQ 5MG BASE;10MG

AB

EQ 5MG BASE;20MG

AB

EQ 5MG BASE;40MG

AB

EQ 10MG BASE;20MG

AB

EQ 10MG BASE;40MG

AB
MYLAN

EQ 2.5MG BASE;10MG

AB

EQ 5MG BASE;10MG

AB

EQ 5MG BASE;20MG

AB

EQ 5MG BASE;40MG

AB

EQ 10MG BASE;20MG

AB

EQ 10MG BASE;40MG

AB
PAR PHARM

EQ 2.5MG BASE;10MG

AB

EQ 5MG BASE;10MG

A203874
A203874
A203874
A203874
A203874
A203874
A203874
A203874
A203874
A203874
A203874
A200465
A200465
A200465
A200465
A200465
A200465
A200465
A200465
A200465
A200465
A200465

001
002
003
004
005
006
007
008
009
010
011
001
002
003
004
005
006
007
008
009
010
011

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov

07,
07,
07,
07,
07,
07,
07,
07,
07,
07,
07,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

N021540
N021540
N021540
N021540
N021540
N021540
N021540
N021540
N021540
N021540
N021540

009
010
011
001
002
003
004
005
006
007
008

Jul
Jul
Jul
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

29,
29,
29,
30,
30,
30,
30,
30,
30,
30,
30,

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

A091431
A091431
A091431
A091431
A091431
A091431
A202239
A202239
A202239
A202239
A202239
A202239
A077183
A077183
A077183
A090149
A077183
A090149
A078466
A078466
A078466
A078466
A078466
A078466
A077375
A077375
A077375
A079047
A077375
A079047
A078381
A078381

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
001
004
002
001
002
003
005
004
006
001
002
003
001
004
002
001
002

Dec
Dec
Dec
Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep
Apr
Apr
Apr
Jul
Apr
Jul
Feb
Feb
Feb
Jul
Feb
Jul
May
May
May
Jul
May
Jul
Jul
Jul

30,
30,
30,
30,
30,
30,
05,
05,
05,
05,
05,
05,
15,
15,
15,
05,
15,
05,
05,
05,
05,
05,
05,
05,
21,
21,
21,
05,
21,
05,
29,
29,

2013

2013

2013

2013

2013

2013

2012

2012

2012

2012

2012

2012

2010

2010

2010

2011

2010

2011

2010

2010

2010

2011

2010

2011

2010

2010

2010

2011

2010

2011

2010

2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-23(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

CAPSULE;ORAL

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

AB
EQ 5MG BASE;20MG

AB
EQ 5MG BASE;40MG

AB
EQ 10MG BASE;20MG

AB
EQ 10MG BASE;40MG

AB
TEVA PHARMS
EQ 2.5MG BASE;10MG

AB
EQ 5MG BASE;10MG

AB
EQ 5MG BASE;20MG

AB
EQ 5MG BASE;40MG

AB
EQ 10MG BASE;20MG

AB
EQ 10MG BASE;40MG

AB
WATSON LABS
EQ 2.5MG BASE;10MG

AB
EQ 5MG BASE;10MG

AB
EQ 5MG BASE;20MG

AB
EQ 10MG BASE;20MG

AB
WATSON LABS INC
EQ 5MG BASE;40MG

AB
EQ 10MG BASE;40MG

LOTREL
AB
NOVARTIS
EQ 2.5MG BASE;10MG

AB
EQ 5MG BASE;10MG

AB
EQ 5MG BASE;20MG

AB
EQ 5MG BASE;40MG

AB
EQ 10MG BASE;20MG

AB
+
EQ 10MG BASE;40MG

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

TABLET;ORAL

TRIBENZOR

DAIICHI SANKYO
EQ 5MG BASE;12.5MG;20MG

EQ 5MG BASE;12.5MG;40MG

EQ 5MG BASE;25MG;40MG

EQ 10MG BASE;12.5MG;40MG

+
EQ 10MG BASE;25MG;40MG

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET;ORAL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

AB
LUPIN LTD

5MG;12.5MG;160MG

AB

5MG;25MG;160MG

AB

10MG;12.5MG;160MG

AB

10MG;25MG;160MG

AB

10MG;25MG;320MG

AB
PAR PHARM

5MG;12.5MG;160MG

AB

5MG;25MG;160MG

AB

10MG;12.5MG;160MG

AB

10MG;25MG;160MG

AB

10MG;25MG;320MG

AB
TEVA PHARMS

5MG;12.5MG;160MG

AB

5MG;25MG;160MG

AB

10MG;12.5MG;160MG

AB

10MG;25MG;160MG

AB

10MG;25MG;320MG

AB
TORRENT PHARMS LTD

5MG;12.5MG;160MG

AB

5MG;25MG;160MG

AB

10MG;12.5MG;160MG

AB

10MG;25MG;160MG

AB

10MG;25MG;320MG

EXFORGE HCT

AB
NOVARTIS

5MG;12.5MG;160MG

AB

5MG;25MG;160MG

AB

10MG;12.5MG;160MG

AB

10MG;25MG;160MG

AB
+

10MG;25MG;320MG

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

TABLET;ORAL

AZOR
DAIICHI SANKYO
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
+
EQ 10MG BASE;40MG

A078381
A078381
A078381
A078381
A077179
A077179
A077179
A077179
A077179
A077179
A077890
A077890
A077890
A077890
A090364
A090364

003
005
004
006
001
002
003
005
004
006
001
002
003
004
001
002

Jul
Jul
Jul
Jul
May
May
May
Jul
May
Jul
Oct
Oct
Oct
Oct
Jul
Jul

29,
29,
29,
29,
18,
18,
18,
05,
18,
05,
14,
14,
14,
14,
05,
05,

2010

2010

2010

2010

2007

2007

2007

2011

2007

2011

2010

2010

2010

2010

2011

2011

N020364
N020364
N020364
N020364
N020364
N020364

002
003
004
007
005
006

Mar
Mar
Mar
Apr
Jun
Apr

03,
03,
03,
11,
20,
11,

1995

1995

1995

2006

2002

2006

N200175
N200175
N200175
N200175
N200175

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

23,
23,
23,
23,
23,

2010

2010

2010

2010

2010

A200797
A200797
A200797
A200797
A200797
A201087
A201087
A201087
A201087
A201087
A200435
A200435
A200435
A200435
A200435
A201593
A201593
A201593
A201593
A201593

001
002
003
004
005
001
002
003
004
005
001
002
005
003
004
001
002
003
004
005

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep
Sep
Jun
Jun
Jun
Jun
Jun

03,
03,
03,
03,
03,
01,
01,
01,
01,
01,
25,
25,
25,
25,
25,
03,
03,
03,
03,
03,

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2012

2012

2012

2012

2012

2015

2015

2015

2015

2015

N022314
N022314
N022314
N022314
N022314

001
002
003
004
005

Apr
Apr
Apr
Apr
Apr

30,
30,
30,
30,
30,

2009

2009

2009

2009

2009

N022100
N022100
N022100
N022100

001
002
003
004

Sep
Sep
Sep
Sep

26,
26,
26,
26,

2007

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-24(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

TABLET;ORAL

PRESTALIA

SYMPLMED PHARMS LLC
EQ 2.5MG BASE;3.5MG
EQ 5MG BASE;7MG
+
EQ 10MG BASE;14MG
AMLODIPINE BESYLATE; TELMISARTAN

TABLET;ORAL

TELMISARTAN AND AMLODIPINE

AB
LUPIN LTD
EQ
AB
EQ
AB
EQ
AB
EQ
AB
MYLAN PHARMS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
TORRENT PHARMS LTD
EQ
AB
EQ
AB
EQ
AB
EQ
TWYNSTA

AB
BOEHRINGER INGELHEIM
EQ
AB
EQ
AB
EQ
AB
+
EQ

N205003 001 Jan 21, 2015

N205003 002 Jan 21, 2015

N205003 003 Jan 21, 2015

5MG BASE;40MG
5MG BASE;80MG
10MG BASE;40MG
10MG BASE;80MG
5MG BASE;40MG
5MG BASE;80MG
10MG BASE;40MG
10MG BASE;80MG
5MG BASE;40MG
5MG BASE;80MG
10MG BASE;40MG
10MG BASE;80MG

A201586
A201586
A201586
A201586
A202516
A202516
A202516
A202516
A202517
A202517
A202517
A202517

001
003
002
004
001
003
002
004
001
003
002
004

Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan

08,
08,
08,
08,
26,
26,
26,
26,
08,
08,
08,
08,

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

5MG BASE;40MG
5MG BASE;80MG
10MG BASE;40MG
10MG BASE;80MG

N022401
N022401
N022401
N022401

001
003
002
004

Oct
Oct
Oct
Oct

16,
16,
16,
16,

2009

2009

2009

2009

AMLODIPINE BESYLATE; VALSARTAN

TABLET;ORAL

AMLODIPINE BESYLATE AND VALSARTAN

AB
ALEMBIC PHARMS LTD
EQ 5MG BASE;160MG
AB
EQ 5MG BASE;320MG
AB
EQ 10MG BASE;160MG
AB
EQ 10MG BASE;320MG
AB
LUPIN
EQ 5MG BASE;160MG
AB
EQ 5MG BASE;320MG
AB
EQ 10MG BASE;160MG
AB
EQ 10MG BASE;320MG
AB
MYLAN PHARMS INC
EQ 5MG BASE;160MG
AB
EQ 5MG BASE;320MG
AB
EQ 10MG BASE;160MG
AB
EQ 10MG BASE;320MG
AB
NOVEL LABS INC
EQ 5MG BASE;160MG
AB
EQ 5MG BASE;320MG
AB
EQ 10MG BASE;160MG
AB
EQ 10MG BASE;320MG
AB
PAR PHARM INC
EQ 5MG BASE;160MG
AB
EQ 5MG BASE;320MG
AB
EQ 10MG BASE;160MG
AB
EQ 10MG BASE;320MG
AB
TEVA PHARMS USA
EQ 5MG BASE;160MG
AB
EQ 5MG BASE;320MG
AB
EQ 10MG BASE;160MG
AB
EQ 10MG BASE;320MG
AB
TORRENT PHARMS LTD
EQ 5MG BASE;160MG
AB
EQ 5MG BASE;320MG
AB
EQ 10MG BASE;160MG
AB
EQ 10MG BASE;320MG
EXFORGE

AB
NOVARTIS
EQ 5MG BASE;160MG
AB
EQ 5MG BASE;320MG
AB
+
EQ 10MG BASE;160MG
AB
+
EQ 10MG BASE;320MG

A202713
A202713
A202713
A202713
A090245
A090245
A090245
A090245
A090483
A090483
A090483
A090483
A202829
A202829
A202829
A202829
A090011
A090144
A090011
A090011
A091235
A091235
A091235
A091235
A202377
A202377
A202377
A202377

001
003
002
004
001
003
002
004
001
003
002
004
001
003
002
004
001
001
002
004
001
003
002
004
001
002
003
004

Apr
Apr
Apr
Apr
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

03,
03,
03,
03,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
28,
28,
28,
28,
30,
30,
30,
30,
30,
30,
30,
30,

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2013

2013

2013

2013

2015

2015

2015

2015

2015

2015

2015

2015

N021990
N021990
N021990
N021990

002
004
003
005

Jun
Jun
Jun
Jun

20,
20,
20,
20,

2007

2007

2007

2007

AMMONIA N-13

INJECTABLE;INTRAVENOUS

AMMONIA N 13

AP
3D IMAGING DRUG
AP
BIOMEDCL RES FDN

A203779 001 Oct 19, 2015

A204352 001 May 01, 2015

AP
AP
AP

BRIGHAM WOMENS HOSP

CARDINAL HEALTH 414
FEINSTEIN

30mCi-300mCi/8ML (3.75-37.5mCi/ML)
48.75mCi-487.5mCi/13ML (3.7537.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
30mCi-300mCi/8ML (3.75-37.5mCi/ML)

A203783 001 Oct 30, 2014

A203700 001 Feb 25, 2013

N022119 001 Aug 23, 2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-25(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMMONIA N-13

INJECTABLE;INTRAVENOUS

AMMONIA N 13
AP
GLOBAL ISOTOPES LLC
AP
IBA MOLECULAR N AM
AP
JOHNS HOPKINS UNIV
AP
KREITCHMAN PET CTR
AP
MCPRF
AP
MIPS CRF
AP
PETNET
AP
SPECTRON MRC LLC
AP
UCLA BIOMEDICAL
AP
UCSF RODIOPHARM
AP
UNIV TX MD ANDERSON
AP
WA UNIV SCH MED
ESSENTIAL ISOTOPES
HOUSTON CYCLOTRON
NCM USA BRONX LLC
PRECISION NUCLEAR
SHERTECH LABS LLC
WI MEDCL CYCLOTRON

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

18.8mCi-188mCi/5ML (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

30mCi-300mCi (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

3.75-260mCi/ML

3.75-260mCi/ML

3.75-260mCi/mL

3.75-260mCi/ML

3.75-260mCi/ML

3.75-260mCi/ML

AMMONIUM CHLORIDE

INJECTABLE;INJECTION

AMMONIUM CHLORIDE IN PLASTIC CONTAINER

+ HOSPIRA

5MEQ/ML

AMMONIUM LACTATE

CREAM;TOPICAL

AMMONIUM LACTATE
AB
PERRIGO NEW YORK
AB
TARO
AB
WATSON LABS INC
LAC-HYDRIN
AB
+ RANBAXY
LOTION;TOPICAL

AMMONIUM LACTATE

AB
PERRIGO NEW YORK

AB
TARO

AB
WATSON LABS INC

LAC-HYDRIN

AB
+ RANBAXY

AMOXAPINE

TABLET;ORAL

AMOXAPINE

WATSON LABS

+

AMOXICILLIN

CAPSULE;ORAL

AMOXICILLIN

AB
AM ANTIBIOTICS

AB

AB
AUROBINDO

AB

AB
DAVA PHARMS INC

AB

AB
HIKMA PHARMS

AB

AB
SANDOZ

AB

AB
SUN PHARM INDS LTD

AB

AB
TEVA

AB
+

AMOXIL

AB
DR REDDYS LABS INC

AB

FOR SUSPENSION;ORAL

AMOXICILLIN

AB
AUROBINDO

A204465
A204667
A204514
A203938
A203321
A204535
A204510
A204455
A203812
A204496
A203933
A204506
A205687
A203543
A204515
A204547
A204366
A204356

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Oct
Apr
Aug
Dec
Feb
Nov
Nov
Apr
Jun
Mar
Jun
Feb
Dec
Dec
Feb
Aug
Sep
Dec

23,
22,
19,
09,
25,
20,
02,
23,
27,
28,
27,
07,
17,
14,
04,
14,
19,
18,

2014

2015

2014

2013

2013

2014

2015

2015

2013

2014

2014

2014

2015

2012

2015

2015

2014

2014

A088366 001 Jun 13, 1984

EQ 12% BASE

EQ 12% BASE

EQ 12% BASE

A075774 001 May 01, 2002

A075883 001 Apr 10, 2003

A076829 001 Feb 07, 2006

EQ 12% BASE

N020508 001 Aug 29, 1996

EQ 12% BASE

EQ 12% BASE

EQ 12% BASE

A075570 001 Jun 23, 2004

A076216 001 May 28, 2004

A075575 001 Jun 11, 2002

EQ 12% BASE

N019155 001 Apr 24, 1985

25MG

50MG

100MG

150MG

A072688
A072689
A072690
A072691

001
001
001
001

Aug
Aug
Aug
Aug

28,
28,
28,
28,

1992

1992

1992

1992

250MG

500MG

250MG

500MG

250MG

500MG

250MG

500MG

250MG

500MG

250MG

500MG

250MG

500MG

A062058
A062058
A065271
A065271
A062884
A062881
A065291
A065291
A064076
A064076
A065016
A065016
A061926
A061926

001

002

001
002
001
001
001
002
001
002
001
002
001

003

Nov
Nov
Feb
Feb
Feb
Feb
Sep
Sep
Apr
Apr

09,
09,
25,
25,
05,
05,
30,
30,
08,
08,

2005

2005

1988

1988

2007

2007

1994

1994

1999

1999

250MG

500MG

A062216 001

A062216 004

200MG/5ML

A065334 001 Dec 28, 2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-26(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMOXICILLIN

FOR SUSPENSION;ORAL

AMOXICILLIN

AB
400MG/5ML
AB
AUROBINDO PHARMA LTD
125MG/5ML
AB
250MG/5ML
AB
DAVA PHARMS INC
125MG/5ML
AB
250MG/5ML
AB
HIKMA
125MG/5ML
AB
200MG/5ML
AB
250MG/5ML
AB
400MG/5ML
AB
SANDOZ
125MG/5ML
AB
200MG/5ML
AB
250MG/5ML
AB
400MG/5ML
AB
TEVA
125MG/5ML
AB
200MG/5ML
AB
+
250MG/5ML
AB
+
400MG/5ML
AB
WOCKHARDT
400MG/5ML
AMOXICILLIN PEDIATRIC

AB
TEVA
50MG/ML
AMOXIL

AB
DR REDDYS LABS INC
50MG/ML
AB
125MG/5ML
AB
200MG/5ML
AB
250MG/5ML
AB
400MG/5ML
LAROTID

AB
DR REDDYS LABS INC
125MG/5ML
AB
250MG/5ML
TABLET;ORAL

AMOXICILLIN

AB
AUROBINDO
500MG
AB
875MG
AB
HIKMA
875MG
AB
SANDOZ
500MG
AB
875MG
AB
SUN PHARM INDS LTD
500MG
AB
875MG
AB
TEVA
500MG
AB
+
875MG
AMOXIL

AB
DR REDDYS LABS INC
500MG
AB
875MG
TABLET, CHEWABLE;ORAL

AMOXICILLIN

AB
SUN PHARM INDS LTD
125MG
AB
250MG
AB
TEVA
125MG
AB
+
250MG
AMOXIL

AB
DR REDDYS LABS INC
125MG
AB
250MG
TABLET, EXTENDED RELEASE;ORAL

MOXATAG

+ PRAGMA PHARMS LLC
775MG
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN

AB
SANDOZ INC
500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M
G

500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M
AB
TEVA PHARMS USA
G

PREVPAC

AB
+ TAKEDA PHARMS USA
500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M
G

A065334
A204030
A204030
A062927
A062927
A065322
A065325
A065322
A065325
A065387
A065378
A065387
A065378
A061931
A065119
A061931
A065119
A065319

002
001
002
001
002
002
002
001
001
001
001
002
002
001

001
002

002
002

Dec
Sep
Sep
Nov
Nov
Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar

28,
15,
15,
25,
25,
19,
19,
19,
19,
26,
26,
26,
26,

2006

2014

2014

1988

1988

2006

2006

2006

2006

2007

2007

2007

2007

Dec 04, 2002

Dec 04, 2002

Jun 18, 2007

A061931 003 Dec 01, 1982

A062226
A062226
N050760
A062226
N050760

005

001

001 Apr 15, 1999

002

002 Apr 15, 1999

A062226 003

A062226 004

A065256
A065256
A065255
A065228
A065228
A065059
A065059
A065056
A065056

001
002
001
001
002
001
002
001
002

Nov
Nov
Mar
Jul
Jul
Nov
Nov
Sep
Sep

09,
09,
29,
13,
13,
24,
24,
18,
18,

2005

2005

2006

2005

2005

2000

2000

2000

2000

N050754 002 Jul 10, 1998

N050754 001 Jul 10, 1998

A065021
A065021
A064013
A064013

001
002
002
001

Dec
Dec
Sep
Dec

23,
23,
11,
22,

1999

1999

1995

1992

N050542 002

N050542 001

N050813 001 Jan 23, 2008

A202588 001 Mar 04, 2014

A200218 001 Aug 30, 2013

N050757 001 Dec 02, 1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-27(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN

+ GASTROENTERO
500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20M
G

AMOXICILLIN; CLAVULANATE POTASSIUM

FOR SUSPENSION;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

AB
HIKMA PHARMS
200MG/5ML;EQ 28.5MG BASE/5ML
AB
400MG/5ML;EQ 57MG BASE/5ML
AB
600MG/5ML;EQ 42.9MG BASE/5ML
AB
SANDOZ
200MG/5ML;EQ 28.5MG BASE/5ML
AB
400MG/5ML;EQ 57MG BASE/5ML
AB
SANDOZ INC
200MG/5ML;EQ 28.5MG BASE/5ML
AB
400MG/5ML;EQ 57MG BASE/5ML
AB
600MG/5ML;EQ 42.9MG BASE/5ML
AB
SUN PHARM INDS LTD
200MG/5ML;EQ 28.5MG BASE/5ML
AB
400MG/5ML;EQ 57MG BASE/5ML
AB
600MG/5ML;EQ 42.9MG BASE/5ML
AB
TEVA
200MG/5ML;EQ 28.5MG BASE/5ML
AB
+
400MG/5ML;EQ 57MG BASE/5ML
AB
+
600MG/5ML;EQ 42.9MG BASE/5ML
AB
WOCKHARDT
250MG/5ML;EQ 62.5MG BASE/5ML
AB
WOCKHARDT EU OPERATN
600MG/5ML;EQ 42.9MG BASE/5ML
AUGMENTIN '125'

AB
DR REDDYS LABS INC
125MG/5ML;EQ 31.25MG BASE/5ML
AUGMENTIN '200'

AB
DR REDDYS LABS INC
200MG/5ML;EQ 28.5MG BASE/5ML
AUGMENTIN '250'

AB
+ DR REDDYS LABS INC
250MG/5ML;EQ 62.5MG BASE/5ML
AUGMENTIN '400'

AB
DR REDDYS LABS INC
400MG/5ML;EQ 57MG BASE/5ML
AUGMENTIN ES-600

AB
DR REDDYS LABS INC
600MG/5ML;EQ 42.9MG BASE/5ML
SUSPENSION;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

AB
AUROBINDO PHARMA LTD
200MG/5ML;EQ 28.5MG BASE/5ML
AB
400MG/5ML;EQ 57MG BASE/5ML
AB
600MG/5ML;EQ 42.9MG BASE/5ML
TABLET;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

AB
AUROBINDO PHARMA LTD
250MG;EQ 125MG BASE
AB
500MG;EQ 125MG BASE
AB
875MG;EQ 125MG BASE
AB
SANDOZ
250MG;EQ 125MG BASE
AB
500MG;EQ 125MG BASE
AB
875MG;EQ 125MG BASE
AB
SANDOZ INC
500MG;EQ 125MG BASE
AB
875MG;EQ 125MG BASE
AB
SUN PHARM INDS LTD
875MG;EQ 125MG BASE
AB
TEVA
500MG;EQ 125MG BASE
AB
TEVA PHARMS USA
875MG;EQ 125MG BASE
AUGMENTIN '250'

AB
+ DR REDDYS LABS INC
250MG;EQ 125MG BASE
AUGMENTIN '500'

AB
+ DR REDDYS LABS INC
500MG;EQ 125MG BASE
AUGMENTIN '875'

AB
+ DR REDDYS LABS INC
875MG;EQ 125MG BASE
TABLET, CHEWABLE;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

AB
SANDOZ
200MG;EQ 28.5MG BASE
AB
400MG;EQ 57MG BASE
SUN PHARM INDS LTD
200MG;EQ 28.5MG BASE
AB
AB
400MG;EQ 57MG BASE
AB
TEVA
200MG;EQ 28.5MG BASE
AB
+
400MG;EQ 57MG BASE
AUGMENTIN '125'

AB
DR REDDYS LABS INC
125MG;EQ 31.25MG BASE
AUGMENTIN '200'

AB
DR REDDYS LABS INC
200MG;EQ 28.5MG BASE
AUGMENTIN '250'

AB
DR REDDYS LABS INC
250MG;EQ 62.5MG BASE

N050824 001 Feb 08, 2011

A065191
A065191
A065373
A065066
A065066
A065098
A065098
A065358
A065132
A065132
A065207
A065089
A065089
A065162
A065431
A065420

002
001
001
001
002
001
002
001
001
002
002
001
002
001
001
001

Jan
Jan
Nov
Jun
Jun
Dec
Dec
Aug
Mar
Mar
Jan
May
May
Mar
Nov
Dec

25,
25,
09,
05,
05,
16,
16,
13,
19,
19,
30,
25,
25,
12,
25,
02,

2005

2005

2007

2002

2002

2002

2002

2007

2003

2003

2007

2004

2004

2004

2008

2013

N050575 001 Aug 06, 1984

N050725 001 May 31, 1996

N050575 002 Aug 06, 1984

N050725 002 May 31, 1996

N050755 001 Jun 22, 2001

A201090 001 Dec 20, 2011

A201090 002 Dec 20, 2011

A201091 001 Dec 20, 2011

A091569
A091569
A091568
A065189
A065064
A065063
A065117
A065093
A065102
A065101
A065096

001
002
001
001
001
001
001
001
001
001
001

Jan
Jan
Jan
Aug
Mar
Mar
Nov
Nov
Sep
Oct
Oct

20,
20,
20,
23,
15,
14,
27,
21,
17,
30,
29,

2012

2012

2012

2005

2002

2002

2002

2002

2002

2002

2002

N050564 001 Aug 06, 1984

N050564 002 Aug 06, 1984

N050720 001 Feb 13, 1996

A065065
A065065
A065161
A065161
A065205
A065205

001
002
001
002
001
002

Apr
Apr
Dec
Dec
Feb
Feb

18,
18,
03,
03,
09,
09,

2002

2002

2003

2003

2005

2005

N050597 001 Jul 22, 1985

N050726 001 May 31, 1996

N050597 002 Jul 22, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

3-28(of 388)

AMOXICILLIN; CLAVULANATE POTASSIUM

TABLET, CHEWABLE;ORAL

AUGMENTIN '400'

AB
DR REDDYS LABS INC
400MG;EQ 57MG BASE
TABLET, EXTENDED RELEASE;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

AB
SANDOZ
1GM;EQ 62.5MG BASE
AUGMENTIN XR

AB
+ DR REDDYS LABS INC
1GM;EQ 62.5MG BASE

N050785 001 Sep 25, 2002

AMPHETAMINE

SUSPENSION, EXTENDED RELEASE;ORAL

DYANAVEL XR

+ TRIS PHARMA INC
EQ 2.5MG BASE/ML

N208147 001 Oct 19, 2015

N050726 002 May 31, 1996

A090227 001 Apr 21, 2010

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE

SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

ADDERALL XR 10

AB
SHIRE
2.5MG;2.5MG;2.5MG;2.5MG
N021303 001 Oct 11,
ADDERALL XR 15

AB
SHIRE
3.75MG;3.75MG;3.75MG;3.75MG
N021303 006 May 22,
ADDERALL XR 20

AB
SHIRE
5MG;5MG;5MG;5MG
N021303 002 Oct 11,
ADDERALL XR 25

AB
SHIRE
6.25MG;6.25MG;6.25MG;6.25MG
N021303 004 May 22,
ADDERALL XR 30

AB
+ SHIRE
7.5MG;7.5MG;7.5MG;7.5MG
N021303 003 Oct 11,
ADDERALL XR 5

AB
SHIRE
1.25MG;1.25MG;1.25MG;1.25MG
N021303 005 May 22,
AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF

AB
TEVA
1.25MG;1.25MG;1.25MG;1.25MG
A077488 001 Apr 29,
AB
2.5MG;2.5MG;2.5MG;2.5MG
A077488 002 Apr 29,
AB
3.75MG;3.75MG;3.75MG;3.75MG
A077488 003 Apr 29,
AB
5MG;5MG;5MG;5MG
A077488 004 Apr 29,
AB
6.25MG;6.25MG;6.25MG;6.25MG
A077488 005 Apr 29,
AB
7.5MG;7.5MG;7.5MG;7.5MG
A077488 006 Apr 29,
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

AB
ACTAVIS ELIZABETH
1.25MG;1.25MG;1.25MG;1.25MG
A077302 001 Jun 22,
AB
2.5MG;2.5MG;2.5MG;2.5MG
A077302 002 Jun 22,
AB
3.75MG;3.75MG;3.75MG;3.75MG
A077302 003 Jun 22,
AB
5MG;5MG;5MG;5MG
A077302 004 Jun 22,
AB
6.25MG;6.25MG;6.25MG;6.25MG
A077302 005 Jun 22,
AB
7.5MG;7.5MG;7.5MG;7.5MG
A077302 006 Jun 22,
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE

AB
BARR LABS INC
1.25MG;1.25MG;1.25MG;1.25MG
A076536 001 Feb 12,
AB
2.5MG;2.5MG;2.5MG;2.5MG
A076536 002 Feb 12,
AB
3.75MG;3.75MG;3.75MG;3.75MG
A076536 003 Feb 12,
AB
5MG;5MG;5MG;5MG
A076536 004 Feb 12,
AB
6.25MG;6.25MG;6.25MG;6.25MG
A076536 005 Feb 12,
AB
7.5MG;7.5MG;7.5MG;7.5MG
A076536 006 Feb 12,
TABLET;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

AB
ACTAVIS ELIZABETH
1.25MG;1.25MG;1.25MG;1.25MG
A040456 001 May 06,
AB
2.5MG;2.5MG;2.5MG;2.5MG
A040456 002 May 06,
AB
5MG;5MG;5MG;5MG
A040456 003 May 06,
AB
7.5MG;7.5MG;7.5MG;7.5MG
A040456 004 May 06,
AB
AUROLIFE PHARMA LLC
1.25MG;1.25MG;1.25MG;1.25MG
A202424 001 Nov 27,
AB
1.875MG;1.875MG;1.875MG;1.875MG
A202424 002 Nov 27,
AB
2.5MG;2.5MG;2.5MG;2.5MG
A202424 003 Nov 27,
AB
3.125MG;3.125MG;3.125MG;3.125MG
A202424 004 Nov 27,
AB
3.75MG;3.75MG;3.75MG;3.75MG
A202424 005 Nov 27,
AB
5MG;5MG;5MG;5MG
A202424 006 Nov 27,
7.5MG;7.5MG;7.5MG;7.5MG
A202424 007 Nov 27,
AB
AB
BARR
1.25MG;1.25MG;1.25MG;1.25MG
A040422 001 Feb 11,
AB
1.875MG;1.875MG;1.875MG;1.875MG
A040422 005 Mar 19,
AB
2.5MG;2.5MG;2.5MG;2.5MG
A040422 002 Feb 11,
AB
3.125MG;3.125MG;3.125MG;3.125MG
A040422 006 Mar 19,
AB
3.75MG;3.75MG;3.75MG;3.75MG
A040422 007 Mar 19,
AB
5MG;5MG;5MG;5MG
A040422 003 Feb 11,
AB
+
7.5MG;7.5MG;7.5MG;7.5MG
A040422 004 Feb 11,
AB
COREPHARMA
1.25MG;1.25MG;1.25MG;1.25MG
A040444 001 Jun 19,
AB
1.875MG;1.875MG;1.875MG;1.875MG
A040444 005 Nov 03,
AB
2.5MG;2.5MG;2.5MG;2.5MG
A040444 002 Jun 19,

2001

2002

2001

2002

2001

2002

2013

2013

2013

2013

2013

2013

2012

2012

2012

2012

2012

2012

2013

2013

2013

2013

2013

2013

2003

2003

2003

2003

2013

2013

2013

2013

2013

2013

2013

2002

2003

2002

2003

2003

2002

2002

2002

2014

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-29(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE

SULFATE

TABLET;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

AB
3.125MG;3.125MG;3.125MG;3.125MG

A040444 006 Nov 03,

AB
3.75MG;3.75MG;3.75MG;3.75MG

A040444 007 Nov 03,

AB
5MG;5MG;5MG;5MG

A040444 003 Jun 19,

AB
7.5MG;7.5MG;7.5MG;7.5MG

A040444 004 Jun 19,

AB
MALLINCKRODT INC
1.25MG;1.25MG;1.25MG;1.25MG

A040440 001 Oct 07,

AB
1.875MG;1.875MG;1.875MG;1.875MG

A040440 002 Oct 07,

AB
2.5MG;2.5MG;2.5MG;2.5MG

A040440 003 Oct 07,

AB
3.125MG;3.125MG;3.125MG;3.125MG

A040440 004 Oct 07,

AB
3.75MG;3.75MG;3.75MG;3.75MG

A040440 005 Oct 07,

AB
5MG;5MG;5MG;5MG

A040440 006 Oct 07,

AB
7.5MG;7.5MG;7.5MG;7.5MG

A040440 007 Oct 07,

AB
MYLAN PHARMS INC
1.25MG;1.25MG;1.25MG;1.25MG

A206721 001 Nov 10,

AB
1.875MG;1.875MG;1.875MG;1.875MG

A206721 002 Nov 10,

AB
2.5MG;2.5MG;2.5MG;2.5MG

A206721 003 Nov 10,

AB
3.125MG;3.125MG;3.125MG;3.125MG

A206721 004 Nov 10,

AB
3.75MG;3.75MG;3.75MG;3.75MG

A206721 005 Nov 10,

AB
5MG;5MG;5MG;5MG

A206721 006 Nov 10,

AB
7.5MG;7.5MG;7.5MG;7.5MG

A206721 007 Nov 10,

AB
SANDOZ
1.25MG;1.25MG;1.25MG;1.25MG

A040439 004 Sep 27,

AB
2.5MG;2.5MG;2.5MG;2.5MG

A040439 001 Jun 14,

AB
5MG;5MG;5MG;5MG

A040439 002 Jun 14,

AB
7.5MG;7.5MG;7.5MG;7.5MG

A040439 003 Jun 14,

AB
SUN PHARM INDS
1.25MG;1.25MG;1.25MG;1.25MG

A040480 001 Sep 09,

AB
1.875MG;1.875MG;1.875MG;1.875MG

A040480 002 Sep 09,

AB
2.5MG;2.5MG;2.5MG;2.5MG

A040480 003 Sep 09,

AB
3.125MG;3.125MG;3.125MG;3.125MG

A040480 004 Sep 09,

AB
3.75MG;3.75MG;3.75MG;3.75MG

A040480 005 Sep 09,

AB
5MG;5MG;5MG;5MG

A040480 006 Sep 09,

AB
7.5MG;7.5MG;7.5MG;7.5MG

A040480 007 Sep 09,
AMPHETAMINE SULFATE

TABLET;ORAL

EVEKEO

ARBOR PHARMS LLC

+

5MG

10MG

AMPHOTERICIN B

INJECTABLE;INJECTION

AMPHOTERICIN B

+ X GEN PHARMS

50MG/VIAL

INJECTABLE, LIPID COMPLEX;INJECTION

ABELCET

+ SIGMA TAU
5MG/ML

AMPHOTEC

+ ALKOPHARMA USA
50MG/VIAL

+
100MG/VIAL

INJECTABLE, LIPOSOMAL;INJECTION

AMBISOME

+ ASTELLAS

50MG/VIAL

AMPICILLIN SODIUM

INJECTABLE;INJECTION

AMPICILLIN SODIUM
AP
ACS DOBFAR SPA
AP
AP
AP
AP
ANTIBIOTICE
AP
AP
AP
AP
AUROBINDO PHARMA
AP
AP
AP
AP
AP
AP
HANFORD GC
AP
AP

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

10GM BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

125MG BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

10GM BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2014

2014

2002

2002

2003

2003

2003

2003

2003

2003

2003

2015

2015

2015

2015

2015

2015

2015

2002

2002

2002

2002

2003

2003

2003

2003

2003

2003

2003

A200166 001 Aug 09, 2012

A200166 002 Aug 09, 2012

A063206 001 Apr 29, 1992

N050724 001 Nov 20, 1995

N050729 001 Nov 22, 1996

N050729 002 Nov 22, 1996

N050740 001 Aug 11, 1997

A090884
A090884
A090884
A090889
A090354
A090354
A090354
A090354
A065499
A065499
A065499
A065499
A065499
A065493
A063145
A063146
A062772

001
002
003
001
001
002
003
004
001
002
003
004
005
001
001
001
001

Apr
Apr
Apr
Apr
Dec
Dec
Dec
Dec
Aug
Aug
Aug
Aug
Aug
Aug
Apr
Apr
Apr

03,
03,
03,
03,
28,
28,
28,
28,
17,
17,
17,
17,
17,
17,
15,
15,
15,

2013

2013

2013

2013

2009

2009

2009

2009

2010

2010

2010

2010

2010

2010

1993

1993

1993

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-30(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMPICILLIN SODIUM

INJECTABLE;INJECTION

AMPICILLIN SODIUM

AP
AP
AP
HOSPIRA INC
AP
AP
AP
AP
AP
ISTITUTO BIO ITA SPA
AP
AP
AP
AP
AP
AP
MYLAN LABS LTD
AP
SAGENT PHARMS
AP
AP
AP
AP
AP
AP
+ SANDOZ
AP
+
AP
+
AP
+
AP
+
AP
+
AP
STRIDES ARCOLAB LTD
AP
AP
AP
POWDER;INTRAVENOUS

AMPICILLIN SODIUM

AP
+ SANDOZ
AP
+

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2GM BASE/VIAL
10GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
10GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE;INJECTION

AMPICILLIN AND SULBACTAM

AP
ACS DOBFAR
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
AP
ANTIBIOTICS SA
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
AUROBINDO PHARMA
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
AP
HANFORD GC
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
AP
HIKMA MAPLE
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
AP
HOSPIRA INC
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
AP
ISTITUTO BIO ITA SPA
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
AP
MUSTAFA NEVZAT ILAC
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
MYLAN LABS LTD
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
AP
SAGENT PHARMS
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

A063140
A063142
A202864
A202864
A202864
A202864
A202865
A201404
A062797
A062719
A062719
A062719
A062797
A202198
A090583
A090583
A090583
A090583
A090583
A090581
A061395
A061395
A061395
A061395
A061395
A061395
A201025
A201025
A201025
A201025

001
001
001
002
003
004
001
001
001
001
003
002
002
001
001
002
003
004
005
001
001

002

003

004

005

006

001
002
003
004

Apr
Apr
Sep
Sep
Sep
Sep
Sep
Dec
Jul
May
May
May
Jul
Apr
Nov
Nov
Nov
Nov
Nov
Oct

15,
15,
04,
04,
04,
04,
04,
20,
12,
12,
12,
12,
12,
07,
27,
27,
27,
27,
27,
20,

1993

1993

2015

2015

2015

2015

2015

2013

1993

1987

1987

1987

1993

2014

2015

2015

2015

2015

2015

2015

Apr
Apr
Apr
Apr

09,
09,
09,
09,

2014

2014

2014

2014

A062738 001 Feb 19, 1987

A062738 002 Feb 19, 1987

A065406
A065406
A065403
A201406
A201406
A090340
A090349
A090340
A090349
A090339
A065176
A065176
A065188
A065074
A065074
A065076
A090375
A090653
A090375
A090653
A090646
A065222
A065222
A065314
A065316
A065316
A201024
A201024
A202197
A090579
A090579
A090578

001
002
001
001
002
001
001
002
002
001
001
002
001
001
002
001
001
001
002
002
001
001
002
001
001
002
001
002
001
001
002
001

Dec
Dec
Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Nov
Nov
Nov
Mar
Mar
Mar
Dec
Dec
Dec
Dec
Dec
Nov
Nov
Nov
Jun
Jun
Apr
Apr
Apr
Jan
Jan
Jan

22,
22,
23,
07,
07,
20,
20,
20,
20,
20,
30,
30,
25,
19,
19,
19,
21,
21,
21,
21,
21,
29,
29,
27,
29,
29,
07,
07,
07,
08,
08,
11,

2009

2009

2009

2015

2015

2010

2010

2010

2010

2010

2005

2005

2005

2002

2002

2002

2011

2011

2011

2011

2011

2005

2005

2006

2007

2007

2014

2014

2014

2016

2016

2016

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-31(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE;INJECTION

AMPICILLIN AND SULBACTAM

AP
SANDOZ
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
UNASYN

AP
+ PFIZER
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
+
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
+
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
+
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
AP
+
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
AMPICILLIN/AMPICILLIN TRIHYDRATE

CAPSULE;ORAL

AMPICILLIN TRIHYDRATE

AB
DAVA PHARMS INC
EQ
AB
+
EQ
AB
SANDOZ
EQ
AB
EQ
FOR SUSPENSION;ORAL

AMPICILLIN TRIHYDRATE

DAVA PHARMS INC
EQ
+
EQ
ANAGRELIDE HYDROCHLORIDE

CAPSULE;ORAL

AGRYLIN

AB
SHIRE LLC
ANAGRELIDE HYDROCHLORIDE

AB
BARR
AB
AB
IMPAX LABS
AB
AB
IVAX SUB TEVA PHARMS
AB
+
AB
MYLAN
AB
AB
MYLAN PHARMS INC
AB
ANASTROZOLE

TABLET;ORAL

ANASTROZOLE

AB
ACCORD HLTHCARE
AB
APOTEX INC
AB
CIPLA LTD
AB
DR REDDYS LABS LTD
AB
FRESENIUS KABI ONCOL
AB
MYLAN
AB
NATCO PHARMA LTD
AB
ROXANE
AB
SANDOZ
AB
SANTOS BIOTECH
AB
SUN PHARM INDS LTD
AB
TEVA PHARMS
AB
ZYDUS PHARMS USA INC
ARIMIDEX

AB
+ ASTRAZENECA

250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE

125MG BASE/5ML
250MG BASE/5ML

A065241
A065310
A065241
A065310
A065240

001
001
002
002
001

Jul
Jul
Jul
Jul
Jul

25,
25,
25,
25,
25,

2006

2006

2006

2006

2006

A062901
A062901
N050608
N050608
N050608

002
001
002
001
005

Feb
Nov
Dec
Dec
Dec

27,
23,
31,
31,
10,

1992

1988

1986

1986

1993

A062883
A062882
A064082
A064082

001
001
001
002

Feb
Feb
Aug
Aug

25,
25,
29,
29,

1988

1988

1995

1995

A062982 001 Feb 10, 1989

A062982 002 Feb 10, 1989

EQ 0.5MG BASE

N020333 001 Mar 14, 1997

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A076530
A076530
A076910
A076910
A076468
A076468
A076811
A076811
A077613
A077613

001
002
001
002
001
002
001
002
001
002

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Jun
Jun

18,
18,
18,
18,
18,
18,
18,
18,
27,
27,

2005

2005

2005

2005

2005

2005

2005

2005

2006

2006

1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG

A090568
A200654
A091164
A090732
A090088
A091051
A079220
A078485
A079007
A078944
A091177
A078058
A078921

001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
May
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jul
Jun
Jun

28,
11,
28,
28,
28,
28,
28,
28,
28,
28,
15,
28,
28,

2010

2012

2010

2010

2010

2010

2010

2010

2010

2010

2011

2010

2010

0.5MG BASE
1MG BASE
0.5MG BASE
1MG BASE
0.5MG BASE
1MG BASE
0.5MG BASE
1MG BASE
0.5MG BASE
1MG BASE

1MG

N020541 001 Dec 27, 1995

ANIDULAFUNGIN

INJECTABLE;IV (INFUSION)

ERAXIS

+ VICURON
+

50MG/VIAL
100MG/VIAL

N021632 001 Feb 17, 2006

N021632 002 Nov 14, 2006

APIXABAN

TABLET;ORAL

ELIQUIS

BRISTOL MYERS SQUIBB
+

2.5MG
5MG

N202155 001 Dec 28, 2012

N202155 002 Dec 28, 2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-32(of 388)

PRESCRIPTION DRUG PRODUCT LIST

APOMORPHINE HYDROCHLORIDE

INJECTABLE;SUBCUTANEOUS

APOKYN

+ US WORLDMEDS

30MG/3ML (10MG/ML)

APRACLONIDINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

APRACLONIDINE HYDROCHLORIDE

AT
AKORN INC
EQ 0.5% BASE
IOPIDINE

AT
+ ALCON
EQ 0.5% BASE
+
EQ 1% BASE
APREMILAST

TABLET;ORAL

OTEZLA

CELGENE CORP
+
APREPITANT

CAPSULE;ORAL

APREPITANT

AB
SANDOZ
AB
AB
EMEND

AB
MERCK
AB
AB
+
FOR SUSPENSION;ORAL

EMEND

+ MSD MERCK CO
ARFORMOTEROL TARTRATE

SOLUTION;INHALATION

BROVANA

+ SUNOVION

A077764 001 Mar 12, 2009

N020258 001 Jul 30, 1993

N019779 001 Dec 31, 1987

10MG
20MG
30MG

N205437 001 Mar 21, 2014

N205437 002 Mar 21, 2014

N205437 003 Mar 21, 2014

40MG
80MG
125MG

A090999 001 Sep 24, 2012

A090999 002 Sep 24, 2012

A090999 003 Sep 24, 2012

40MG
80MG
125MG

N021549 003 Jun 30, 2006

N021549 001 Mar 26, 2003

N021549 002 Mar 26, 2003

125MG/KIT

N207865 001 Dec 17, 2015

EQ 0.015MG BASE/2ML

N021912 001 Oct 06, 2006

ARGATROBAN

INJECTABLE;INJECTION

ARGATROBAN

AP
FRESENIUS KABI USA
250MG/2.5ML (100MG/ML)
AP
HIKMA PHARM CO LTD
250MG/2.5ML (100MG/ML)
AP
MYLAN INSTITUTIONAL
250MG/2.5ML (100MG/ML)
AP
PAR STERILE PRODUCTS
250MG/2.5ML (100MG/ML)
AP
+ PFIZER
250MG/2.5ML (100MG/ML)
INJECTABLE;IV (INFUSION)

ARGATROBAN IN 0.9% SODIUM CHLORIDE

TEVA PHARMS USA
250MG/250ML (1MG/ML)
ARGATROBAN IN SODIUM CHLORIDE

+ EAGLE PHARMS
50MG/50ML (1MG/ML)
+ SANDOZ
125MG/125ML (1MG/ML)
ARGININE HYDROCHLORIDE

INJECTABLE;INJECTION

R-GENE 10

+ PHARMACIA AND UPJOHN

N021264 002 Apr 20, 2004

10GM/100ML

ARIPIPRAZOLE

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ABILIFY MAINTENA KIT

OTSUKA PHARM CO LTD
300MG/VIAL
300MG
+
400MG/VIAL
400MG
INJECTABLE;INTRAMUSCULAR

ABILIFY

+ OTSUKA
9.75MG/1.3ML (7.5MG/ML)
SOLUTION;ORAL

ARIPIPRAZOLE

AA
AMNEAL PHARMS
1MG/ML
AA
APOTEX INC
1MG/ML
AA
SILARX PHARMS INC
1MG/ML

N201811
N203049
A202626
A091665
N020883

001
001
001
001
001

Mar
Jan
Jun
Jun
Jun

23,
05,
30,
30,
30,

2015

2012

2014

2014

2000

N206769 001 Dec 15, 2014

N022434 001 Jun 29, 2011

N022485 001 May 09, 2011

N016931 001

N202971
N202971
N202971
N202971

001
003
002
004

Feb
Sep
Feb
Sep

28,
29,
28,
29,

2013

2014

2013

2014

N021866 001 Sep 20, 2006

A203906 001 Aug 14, 2015

A204094 001 Sep 30, 2015

A204171 001 Aug 14, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-33(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ARIPIPRAZOLE

TABLET;ORAL

ABILIFY

AB
OTSUKA
2MG

AB
+
5MG

AB
+
10MG

AB
15MG

AB
20MG

AB
30MG

ARIPIPRAZOLE

AB
ALEMBIC PHARMS LTD
2MG

AB
5MG

AB
10MG

AB
15MG

AB
20MG

AB
30MG

AB
APOTEX INC
2MG

AB
5MG

AB
10MG

AB
15MG

AB
20MG

AB
30MG

AB
AUROBINDO PHARMA LTD
2MG

AB
5MG

AB
10MG

AB
15MG

AB
20MG

AB
30MG

AB
HETERO LABS LTD V
2MG

AB
5MG

AB
10MG

AB
15MG

AB
20MG

AB
30MG

AB
TEVA PHARMS USA
2MG

AB
5MG

AB
10MG

AB
15MG

AB
20MG

AB
30MG

AB
TORRENT PHARMS LTD
2MG

AB
10MG

AB
5MG

AB
15MG

AB
20MG

AB
30MG

TABLET, ORALLY DISINTEGRATING;ORAL

ABILIFY

AB
+ OTSUKA
10MG

AB
15MG

ARIPIPRAZOLE

AB
ALEMBIC PHARMS LTD
10MG

AB
15MG

ARIPIPRAZOLE LAUROXIL

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ARISTADA

ALKERMES INC

441MG/1.6ML (275.63MG/ML)

662MG/2.4ML (275.83MG/ML)

+

882MG/3.2ML (275.63MG/ML)

ARMODAFINIL

TABLET;ORAL

NUVIGIL

CEPHALON

50MG

150MG

200MG

250MG

N021436
N021436
N021436
N021436
N021436
N021436

006
005
001
002
003
004

Nov
Nov
Nov
Nov
Nov
Nov

15,
15,
15,
15,
15,
15,

2002

2002

2002

2002

2002

2002

A202101
A202101
A202101
A202101
A202101
A202101
A078583
A078583
A078583
A078583
A078583
A078583
A203908
A203908
A203908
A203908
A203908
A203908
A205064
A205064
A205064
A205064
A205064
A205064
A078607
A078607
A078608
A078708
A078708
A078708
A201519
A201519
A201519
A201519
A201519
A201519

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
001
001
002
003
001
003
002
004
005
006

Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

28,
28,
28,
28,
28,
28,
24,
24,
24,
24,
24,
24,
08,
08,
08,
08,
08,
08,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

N021729 002 Jun 07, 2006

N021729 003 Jun 07, 2006

A202102 001 Apr 28, 2015

A202102 002 Apr 28, 2015

N207533 001 Oct 05, 2015

N207533 002 Oct 05, 2015

N207533 003 Oct 05, 2015

N021875
N021875
N021875
N021875

001
003
005
004

Jun
Jun
Mar
Jun

15,
15,
26,
15,

2007

2007

2009

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

3-34(of 388)

ARSENIC TRIOXIDE

INJECTABLE;INJECTION

TRISENOX

+ CEPHALON

1MG/ML

N021248 001 Sep 25, 2000

ARTEMETHER; LUMEFANTRINE

TABLET;ORAL

COARTEM

+ NOVARTIS

20MG;120MG

N022268 001 Apr 07, 2009

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

AP
HOSPIRA
4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG
BASE/ML)

SEPTOCAINE

AP
+ DEPROCO
4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG
BASE/ML)

ORABLOC

PIERREL
4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG
BASE/ML)

+
4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG
BASE/ML)

SEPTOCAINE

+ DEPROCO
4%;EQ 0.0085MG BASE/1.7ML (4%;EQ
0.005MG BASE/ML)

A079138 001 Jun 18, 2010

N020971 001 Apr 03, 2000

N022466 001 Feb 26, 2010

N022466 002 Feb 26, 2010

N022010 001 Mar 30, 2006

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

INJECTABLE;IV (INFUSION)

INFUVITE PEDIATRIC

+ SANDOZ
80MG/VIAL;0.02MG/VIAL;400
N021265 001 Feb 21, 2001

IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI

AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/

VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

+ SANDOZ
80MG/VIAL;0.02MG/VIAL;400
N021646 001 Jan 29, 2004

IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI

AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/

VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE;

VITAMIN A; VITAMIN E

FOR SOLUTION;IV (INFUSION)

M.V.I. PEDIATRIC

+ HOSPIRA
80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/
N018920 001 Sep 21, 2000

VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;

0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG

BASE/VIAL;0.7MG/VIAL;7MG/VIAL

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;

VITAMIN E

INJECTABLE;INJECTION

M.V.I.-12 (WITHOUT VITAMIN K)

+ HOSPIRA
20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;
N008809 006 Sep 09, 2004

0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0

.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;

VITAMIN E; VITAMIN K

INJECTABLE;IV (INFUSION)

M.V.I. ADULT

+ HOSPIRA
200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M
N021625 001 Jan 30, 2004

G/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIA

L;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL

;10MG/VIAL;0.15MG/VIAL

M.V.I. ADULT (PHARMACY BULK PACKAGE)

+ HOSPIRA
200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5
N021643 001 Feb 18, 2004

ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5

ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0

.15MG/5ML

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-35(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE;

SODIUM SULFATE

FOR SOLUTION;ORAL

MOVIPREP

+ SALIX PHARMS
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
N021881 001 Aug 02, 2006
ASENAPINE MALEATE

TABLET;SUBLINGUAL

SAPHRIS

FOREST LABS LLC
+

EQ 5MG BASE

EQ 10MG BASE

ASPIRIN

CAPSULE, EXTENDED RELEASE;ORAL

DURLAZA

+ NEW HAVEN PHARMS
162.5MG

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

FIORINAL

AA
+ ACTAVIS LABS UT INC
325MG;50MG;40MG

LANORINAL

AA
LANNETT
325MG;50MG;40MG

TABLET;ORAL

BUTALBITAL, ASPIRIN AND CAFFEINE

AA
+ HIKMA INTL PHARMS
325MG;50MG;40MG

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE;ORAL

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE

AB
COASTAL PHARMS
325MG;50MG;40MG;30MG

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

AB
NEXGEN PHARMA INC
325MG;50MG;40MG;30MG

AB
STEVENS J
325MG;50MG;40MG;30MG

FIORINAL W/CODEINE

AB
+ ACTAVIS LABS UT INC
325MG;50MG;40MG;30MG

N022117 001 Aug 13, 2009

N022117 002 Aug 13, 2009

N200671 001 Sep 04, 2015

N017534 005 Apr 16, 1986

A086996 002 Oct 11, 1985

A086162 002 Feb 16, 1984

A203335 001 Oct 30, 2015

A075231 001 Nov 30, 2001

A074951 001 Aug 31, 1998

N019429 003 Oct 26, 1990

ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE;ORAL

SYNALGOS-DC

+ SUN PHARM INDS
356.4MG;30MG;16MG

N011483 004 Sep 06, 1983

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

TABLET;ORAL

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE

SANDOZ

385MG;30MG;25MG

+

770MG;60MG;50MG

A074654 001 Dec 31, 1996

A074654 002 Dec 31, 1996

ASPIRIN; CARISOPRODOL

TABLET;ORAL

CARISOPRODOL AND ASPIRIN

AB
HERITAGE PHARMS INC
AB
MIRROR PHARMS
AB
PROSAM LABS
AB
SANDOZ
SOMA COMPOUND
AB
+ MEDA PHARMS

325MG;200MG

325MG;200MG

325MG;200MG

325MG;200MG

A089594
A040832
A040252
A040116

325MG;200MG

N012365 005 Jul 11, 1983

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

TABLET;ORAL

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

AB
SANDOZ
325MG;200MG;16MG

SOMA COMPOUND W/ CODEINE

AB
+ MEDA PHARMS
325MG;200MG;16MG

ASPIRIN; DIPYRIDAMOLE

CAPSULE, EXTENDED RELEASE;ORAL

AGGRENOX

AB
+ BOEHRINGER INGELHEIM
25MG;200MG

ASPIRIN AND DIPYRIDAMOLE

AB
BARR
25MG;200MG

001
001
001
001

Mar
Jan
Dec
Apr

31,
07,
10,
25,

1989

2010

1997

1996

A040118 001 Apr 16, 1996

N012366 002 Jul 11, 1983

N020884 001 Nov 22, 1999

A078804 001 Aug 14, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-36(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ASPIRIN; METHOCARBAMOL

TABLET;ORAL

METHOCARBAMOL AND ASPIRIN

+ STEVENS J

325MG;400MG

ASPIRIN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

OXYCODONE AND ASPIRIN

AA
ACTAVIS LABS FL INC
325MG;4.8355MG
AA
COASTAL PHARMS
325MG;4.8355MG
PERCODAN

AA
+ ENDO PHARMS
325MG;4.8355MG
ATAZANAVIR SULFATE

CAPSULE;ORAL

ATAZANAVIR SULFATE

AB
TEVA PHARMS USA
AB
AB
REYATAZ

AB
BRISTOL MYERS SQUIBB
AB
AB
+
ATAZANAVIR SULFATE

TEVA PHARMS USA
POWDER;ORAL

REYATAZ

+ BRISTOL MYERS SQUIBB

A081145 001 Jan 31, 1995

A090084 001 Mar 22, 2011

A091670 001 Mar 16, 2011

N007337 007 Aug 05, 2005

EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE

A091673 002 Apr 22, 2014

A091673 003 Apr 22, 2014

A091673 004 Apr 22, 2014

EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE

N021567 002 Jun 20, 2003

N021567 003 Jun 20, 2003

N021567 004 Oct 16, 2006

EQ 100MG BASE

A091673 001 Apr 22, 2014

EQ 50MG BASE/PACKET

N206352 001 Jun 02, 2014

ATAZANAVIR SULFATE; COBICISTAT

TABLET;ORAL

EVOTAZ

+ BRISTOL MYERS SQUIBB
EQ 300MG BASE;150MG

N206353 001 Jan 29, 2015

ATENOLOL

TABLET;ORAL

ATENOLOL

AB
ALVOGEN IPCO SARL
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
DAVA PHARMS INC
AB
AB
IPCA LABS LTD
AB
AB
AB
MYLAN
AB
AB
AB
NORTHSTAR HLTHCARE
AB
AB
AB
SANDOZ
AB
AB
AB
SUN PHARM INDS
AB
AB
AB
SUN PHARM INDS INC
AB
AB
AB
TEVA
AB
AB
AB
UNIQUE PHARM LABS
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
TENORMIN

AB
ALVOGEN IPCO SARL

25MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A073646
A072303
A072304
A078512
A078512
A078512
A073542
A073543
A077877
A077877
A077877
A073457
A073457
A073457
A078254
A078254
A078254
A074052
A073025
A073026
A074499
A073475
A073476
A078210
A078210
A078210
A074056
A074056
A074056
A077443
A077443
A077443
A076900
A076900
A076900

001
001
001
001
002
003
001
001
001
002
003
002
003
001
001
002
003
001
001
001
001
001
001
001
002
003
003
001
002
001
002
003
001
002
003

25MG

N018240 004 Apr 09, 1990

Jul
Jul
Jul
Oct
Oct
Oct
Dec
Dec
Dec
Dec
Dec
Apr
Jan
Jan
Sep
Sep
Sep
May
Sep
Sep
Jul
Mar
Mar
Jul
Jul
Jul
Jul
Jan
Jan
Sep
Sep
Sep
Jan
Jan
Jan

31,
15,
15,
31,
31,
31,
19,
19,
27,
27,
27,
26,
24,
24,
25,
25,
25,
01,
17,
17,
30,
30,
30,
10,
10,
10,
19,
18,
18,
13,
13,
13,
28,
28,
28,

1992

1988

1988

2007

2007

2007

1991

1991

2006

2006

2006

1999

1992

1992

2009

2009

2009

1992

1991

1991

1997

1993

1993

2007

2007

2007

2004

1995

1995

2006

2006

2006

2005

2005

2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-37(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ATENOLOL

TABLET;ORAL

TENORMIN

AB
AB
+

50MG
100MG

N018240 001

N018240 002

ATENOLOL; CHLORTHALIDONE

TABLET;ORAL

ATENOLOL AND CHLORTHALIDONE

AB
ALVOGEN IPCO SARL
50MG;25MG
AB
100MG;25MG
AB
MUTUAL PHARM
50MG;25MG
AB
100MG;25MG
AB
MYLAN
50MG;25MG
AB
100MG;25MG
AB
WATSON LABS
50MG;25MG
AB
100MG;25MG
TENORETIC 100

AB
+ ALVOGEN IPCO SARL
100MG;25MG
TENORETIC 50

AB
ALVOGEN IPCO SARL
50MG;25MG
ATOMOXETINE HYDROCHLORIDE

CAPSULE;ORAL

STRATTERA

LILLY

ATORVASTATIN CALCIUM

TABLET;ORAL

ATORVASTATIN CALCIUM

AB
APOTEX INC
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
KREMERS URBAN PHARMS
AB
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
SANDOZ INC
AB
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
LIPITOR

AB
PFIZER
AB
AB
AB
+
ATOVAQUONE

SUSPENSION;ORAL

ATOVAQUONE

AB
AMNEAL PHARMS
MEPRON

AB
+ GLAXOSMITHKLINE LLC

10MG
18MG
25MG
40MG
60MG
80MG
100MG

A072301
A072302
A073581
A073582
A074203
A074203
A073665
A073665

001
001
001
001
001
002
001
002

May
May
Apr
Apr
Oct
Oct
Jul
Jul

31,
31,
29,
29,
31,
31,
02,
02,

1990

1990

1993

1993

1993

1993

1992

1992

N018760 001 Jun 08, 1984

N018760 002 Jun 08, 1984

N021411
N021411
N021411
N021411
N021411
N021411
N021411

002
003
004
005
006
007
008

Nov
Nov
Nov
Nov
Nov
Feb
Feb

26,
26,
26,
26,
26,
14,
14,

2002

2002

2002

2002

2002

2005

2005

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A090548
A090548
A090548
A090548
A091650
A091650
A091650
A202357
A091624
A091624
A091624
A091624
A091226
A091226
A091226
A091226
A077575
A077575
A077575
A077575
A076477
A076477
A076477
A076477

001
002
003
004
001
002
003
001
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

May
May
May
May
Jul
Jul
Jul
Jul
Apr
Apr
Apr
Apr
May
May
May
May
May
May
May
May
Nov
Nov
Nov
Nov

29,
29,
29,
29,
17,
17,
17,
17,
05,
05,
05,
05,
29,
29,
29,
29,
29,
29,
29,
29,
30,
30,
30,
30,

2012

2012

2012

2012

2012

2012

2012

2012

2013

2013

2013

2013

2012

2012

2012

2012

2012

2012

2012

2012

2011

2011

2011

2011

EQ
EQ
EQ
EQ

10MG
20MG
40MG
80MG

BASE
BASE
BASE
BASE

N020702
N020702
N020702
N020702

001
002
003
004

Dec
Dec
Dec
Apr

17,
17,
17,
07,

1996

1996

1996

2000

750MG/5ML

A202960 001 Mar 18, 2014

750MG/5ML

N020500 001 Feb 08, 1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-38(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

TABLET;ORAL

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

AB
GLENMARK GENERICS
62.5MG;25MG
AB
250MG;100MG
AB
MYLAN PHARMS INC
62.5MG;25MG
AB
250MG;100MG
MALARONE

AB
+ GLAXOSMITHKLINE
250MG;100MG
MALARONE PEDIATRIC

AB
GLAXOSMITHKLINE
62.5MG;25MG

A091211
A091211
A202362
A202362

002
001
001
002

Apr
Jan
May
May

06,
12,
27,
27,

2015

2011

2014

2014

N021078 001 Jul 14, 2000

N021078 002 Jul 14, 2000

ATRACURIUM BESYLATE

INJECTABLE;INJECTION

ATRACURIUM BESYLATE

AP
AUROBINDO PHARMA LTD
10MG/ML
AP
+ EUROHLTH INTL SARL
10MG/ML
AP
HOSPIRA INC
10MG/ML
AP
SAGENT PHARMS
10MG/ML
ATRACURIUM BESYLATE PRESERVATIVE FREE

AP
AUROBINDO PHARMA LTD
10MG/ML
AP
+ EUROHLTH INTL SARL
10MG/ML
AP
HOSPIRA INC
10MG/ML
AP
SAGENT PHARMS
10MG/ML

A206011
A074901
A090761
A091489

001
001
001
001

Apr
Jul
Oct
Feb

08,
18,
18,
17,

2015

1997

2012

2012

A206010
A074900
A090782
A091488

001
001
001
001

Apr
Jul
Oct
Feb

08,
18,
18,
17,

2015

1997

2012

2012

ATROPINE

INJECTABLE;INJECTION

ATROPEN

+ MERIDIAN MEDCL TECHN
+
+
+

N017106
N017106
N017106
N017106

004 Sep 17, 2004

003 Jun 19, 2003

002 Jun 19, 2003

001

EQ
EQ
EQ
EQ

0.25MG SULFATE/0.3ML
0.5MG SULFATE/0.7ML
1MG SULFATE/0.7ML
2MG SULFATE/0.7ML

ATROPINE SULFATE

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

ATROPINE SULFATE ANSYR PLASTIC SYRINGE

+ HOSPIRA
0.05MG/ML
+
0.1MG/ML
SOLUTION/DROPS;OPHTHALMIC

ATROPINE SULFATE

+ AKORN
1%

N206289 001 Jul 18, 2014

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

TABLET;ORAL

MOTOFEN

+ SEBELA IRELAND LTD
0.025MG;1MG

N017744 002

ATROPINE SULFATE; DIPHENOXYLATE

SOLUTION;ORAL

DIPHENOXYLATE HYDROCHLORIDE
AA
+ ROXANE
TABLET;ORAL

DIPHENOXYLATE HYDROCHLORIDE
AA
LANNETT
AA
MYLAN
AA
PAR PHARM
LOMOTIL

AA
+ GD SEARLE LLC
LONOX

AA
SANDOZ

N021146 002 Jul 09, 2001

N021146 001 Jul 09, 2001

HYDROCHLORIDE

AND ATROPINE SULFATE

0.025MG/5ML;2.5MG/5ML

A087708 001 May 03, 1982

AND ATROPINE SULFATE

0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG

A085372 001

A085762 001

A040357 001 May 02, 2000

0.025MG;2.5MG

N012462 001

0.025MG;2.5MG

A085311 002

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

INJECTABLE;INJECTION

ENLON-PLUS

+ MYLAN INSTITUTIONAL
0.14MG/ML;10MG/ML

N019678 001 Nov 06, 1991

ATROPINE; PRALIDOXIME CHLORIDE

INJECTABLE;INTRAMUSCULAR

DUODOTE

+ MERIDIAN MEDCL
2.1MG/0.7ML;600MG/2ML

N021983 001 Sep 28, 2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-39(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AURANOFIN

CAPSULE;ORAL

RIDAURA

+ PROMETHEUS LABS

3MG

N018689 001 May 24, 1985

50MG
100MG
200MG

N202276 001 Apr 27, 2012

N202276 002 Apr 27, 2012

N202276 003 Apr 27, 2012

AVIBACTAM SODIUM; CEFTAZIDIME

POWDER;IV (INFUSION)

AVYCAZ

+ CEREXA INC

EQ 0.5GM BASE;2GM/VIAL

N206494 001 Feb 25, 2015

AXITINIB

TABLET;ORAL

INLYTA

PFIZER
+

1MG
5MG

N202324 001 Jan 27, 2012

N202324 002 Jan 27, 2012

AVANAFIL

TABLET;ORAL

STENDRA

VIVUS
+

AZACITIDINE

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

AZACITIDINE

AP
DR REDDYS LABS LTD
100MG/VIAL
VIDAZA

AP
+ CELGENE
100MG/VIAL
AZATHIOPRINE

TABLET;ORAL

AZASAN

AB
AAIPHARMA LLC
AB
AB
AB
AZATHIOPRINE

AB
AMNEAL PHARMS LLC
AB
MYLAN
AB
ZYDUS PHARMS USA
AB
AB
AB
IMURAN

AB
+ PROMETHEUS LABS
AZATHIOPRINE SODIUM

INJECTABLE;INJECTION

AZATHIOPRINE SODIUM

+ EUROHLTH INTL SARL
AZELAIC ACID

AEROSOL, FOAM;TOPICAL

FINACEA

+ BAYER HLTHCARE
CREAM;TOPICAL

AZELEX

+ ALLERGAN
GEL;TOPICAL

FINACEA

+ BAYER HLTHCARE
AZELASTINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AZELASTINE HYDROCHLORIDE

AT
ALCON PHARMA
AT
APOTEX INC
AT
SUN PHARMA GLOBAL
OPTIVAR

AT
+ MEDA PHARMS
SPRAY, METERED;NASAL

ASTELIN

AB
+ MEDA PHARMS
ASTEPRO

AB
+ MEDA PHARMS

A201537 001 Sep 16, 2013

N050794 001 May 19, 2004

25MG
50MG
75MG
100MG

A075252
A075252
A075252
A075252

002
001
003
004

Feb
Jun
Feb
Feb

03,
07,
03,
03,

2003

1999

2003

2003

50MG
50MG
25MG
50MG
75MG
100MG

A074069
A075568
A077621
A077621
A077621
A077621

001
001
002
001
003
004

Feb
Dec
Sep
Mar
Sep
Sep

16,
13,
05,
15,
05,
05,

1996

1999

2008

2007

2008

2008

50MG

N016324 001

EQ 100MG BASE/VIAL

A074419 001 Mar 31, 1995

15%

N207071 001 Jul 29, 2015

20%

N020428 001 Sep 13, 1995

15%

N021470 001 Dec 24, 2002

0.05%
0.05%
0.05%

A202305 001 May 31, 2012

A078621 001 Aug 03, 2009

A078738 001 Jun 21, 2010

0.05%

N021127 001 May 22, 2000

EQ 0.125MG BASE/SPRAY

N020114 001 Nov 01, 1996

EQ 0.1876MG BASE/SPRAY

N022203 002 Aug 31, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-40(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AZELASTINE HYDROCHLORIDE

SPRAY, METERED;NASAL

AZELASTINE HYDROCHLORIDE
AB
APOTEX INC
AB
AB
BRECKENRIDGE PHARMS
AB
PERRIGO ISRAEL
AB
ROXANE
AB
SUN PHARMA GLOBAL

EQ
EQ
EQ
EQ
EQ
EQ

0.125MG BASE/SPRAY

0.1876MG BASE/SPRAY

0.125MG BASE/SPRAY

0.1876MG BASE/SPRAY

0.125MG BASE/SPRAY

0.125MG BASE/SPRAY

A077954
A201846
A090176
A202743
A091444
A090423

001
001
001
001
001
001

Apr
Aug
Jul
May
Oct
May

30,
31,
28,
08,
24,
23,

2009

2012

2015

2014

2014

2012

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL

DYMISTA

+ MEDA PHARMS
EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY

N202236 001 May 01, 2012

AZILSARTAN KAMEDOXOMIL

TABLET;ORAL

EDARBI

ARBOR PHARMS IRELAND
+

N200796 001 Feb 25, 2011

N200796 002 Feb 25, 2011

EQ 40MG MEDOXOMIL

EQ 80MG MEDOXOMIL

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

TABLET;ORAL

EDARBYCLOR

ARBOR PHARMS IRELAND
EQ 40MG MEDOXOMIL;12.5MG

+

EQ 40MG MEDOXOMIL;25MG

AZITHROMYCIN

FOR SUSPENSION;ORAL

AZITHROMYCIN

AB
LUPIN LTD

EQ 100MG BASE/5ML

AB

EQ 200MG BASE/5ML

AB
PLIVA

EQ 100MG BASE/5ML

AB

EQ 200MG BASE/5ML

AB
TEVA PHARMS

EQ 100MG BASE/5ML

AB

EQ 200MG BASE/5ML

ZITHROMAX

AB
PFIZER
EQ 100MG BASE/5ML

AB
+
EQ 200MG BASE/5ML

+
EQ 1GM BASE/PACKET

FOR SUSPENSION, EXTENDED RELEASE;ORAL

ZMAX

+ PF PRISM CV

EQ 2GM BASE/BOT

INJECTABLE;INJECTION

AZITHROMYCIN

AP
AUROBINDO PHARMA LTD
EQ 500MG BASE/VIAL

AP
FRESENIUS KABI USA

EQ 500MG BASE/VIAL

AP
GLAND PHARMA LTD

EQ 500MG BASE/VIAL

AP
HOSPIRA

EQ 500MG BASE/VIAL

AP

EQ 500MG BASE/VIAL

AP
SAGENT STRIDES

EQ 500MG BASE/VIAL

AP
SUN PHARM INDS LTD

EQ 500MG BASE/VIAL

ZITHROMAX

AP
+ PFIZER

EQ 500MG BASE/VIAL

SOLUTION/DROPS;OPHTHALMIC

AZASITE

+ OAK PHARMS INC

1%

TABLET;ORAL

AZITHROMYCIN

AB
APOTEX CORP

EQ 250MG BASE

AB

EQ 500MG BASE

AB

EQ 600MG BASE

AB
LUPIN LTD

EQ 250MG BASE

AB

EQ 500MG BASE

AB

EQ 600MG BASE

AB
MYLAN

EQ 250MG BASE

AB

EQ 500MG BASE

AB

EQ 600MG BASE

AB
PLIVA

EQ 250MG BASE

AB

EQ 500MG BASE

AB

EQ 600MG BASE

AB
SANDOZ

EQ 250MG BASE

AB

EQ 500MG BASE

AB

EQ 600MG BASE

N202331 001 Dec 20, 2011

N202331 002 Dec 20, 2011

A065488
A065488
A065246
A065246
A065419
A065419

001
002
002
001
001
002

May
May
Jul
Jul
Jun
Jun

15,
15,
05,
05,
24,
24,

2015

2015

2006

2006

2008

2008

N050710 001 Oct 19, 1995

N050710 002 Oct 19, 1995

N050693 001 Sep 28, 1994

N050797 001 Jun 10, 2005

A203294
A065179
A065501
A065500
A065511
A065506
A090923

001
001
001
001
001
001
001

Jun
Dec
Nov
Jun
Jun
Mar
Apr

19,
13,
09,
26,
26,
24,
02,

2015

2005

2009

2009

2009

2009

2013

N050733 001 Jan 30, 1997

N050810 001 Apr 27, 2007

A065507
A065509
A065508
A065398
A065399
A065400
A065365
A065366
A065360
A065225
A065223
A065218
A065211
A065212
A065209

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jul
Jul
Jul
May
May
May
May
May
Jan
Nov
Nov
Nov
Nov
Nov
Nov

13,
13,
13,
15,
15,
15,
30,
30,
08,
14,
14,
14,
14,
14,
14,

2011

2011

2011

2015

2015

2015

2007

2007

2007

2005

2005

2005

2005

2005

2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-41(of 388)

PRESCRIPTION DRUG PRODUCT LIST

AZITHROMYCIN

TABLET;ORAL

AZITHROMYCIN

AB
TEVA
AB
AB
AB
WOCKHARDT
AB
AB
ZITHROMAX

AB
PFIZER
AB
AB
+

EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
600MG
250MG
500MG
600MG

BASE
BASE
BASE
BASE
BASE
BASE

EQ 250MG BASE
EQ 500MG BASE
EQ 600MG BASE

AZTREONAM

FOR SOLUTION;INHALATION

CAYSTON

+ GILEAD
75MG/VIAL
INJECTABLE;INJECTION

AZACTAM

AP
+ BRISTOL MYERS SQUIBB
1GM/VIAL
AP
+
2GM/VIAL
AZTREONAM

AP
EUROHLTH INTL SARL
1GM/VIAL
AP
2GM/VIAL
AP
FRESENIUS KABI USA
1GM/VIAL
AP
2GM/VIAL
AZACTAM IN PLASTIC CONTAINER

+ BRISTOL MYERS SQUIBB
20MG/ML
+
40MG/ML
AZTREONAM

FRESENIUS KABI USA
500MG/VIAL
BACITRACIN

INJECTABLE;INJECTION

BACIIM

AP
X GEN PHARMS
BACITRACIN

AP
FRESENIUS KABI USA
AP
+ PHARMACIA AND UPJOHN
AP
SAGENT STRIDES
AP
XELLIA PHARMS APS
PHARMACIA AND UPJOHN
OINTMENT;OPHTHALMIC

BACITRACIN

+ PERRIGO CO TENNESSEE

A065153
A065193
A065150
A065404
A065405
A065302

001
001
001
001
001
003

Nov
Nov
Nov
Feb
Feb
Feb

14,
14,
14,
11,
11,
11,

2005

2005

2005

2008

2008

2008

N050711 001 Jul 18, 1996

N050784 001 May 24, 2002

N050730 001 Jun 12, 1996

N050814 001 Feb 22, 2010

N050580 002 Dec 31, 1986

N050580 003 Dec 31, 1986

A065286
A065286
A065439
A065439

001
002
002
003

Mar
Mar
Jun
Jun

23,
23,
18,
18,

2011

2011

2010

2010

N050632 002 May 24, 1989

N050632 001 May 24, 1989

A065439 001 Jun 18, 2010

50,000 UNITS/VIAL

A064153 001 May 09, 1997

50,000
50,000
50,000
50,000
10,000

A065116
A060733
A090211
A203177
A060733

UNITS/VIAL
UNITS/VIAL
UNITS/VIAL
UNITS/VIAL
UNITS/VIAL

500 UNITS/GM

001 Dec 03, 2002

002

001 May 11, 2010

001 Aug 25, 2014

001

A061212 001

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

AT
AKORN
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
A065213 001 Jul 25, 2012

UNITS/GM

AT
+ BAUSCH AND LOMB
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
A064068 001 Oct 30, 1995

UNITS/GM

OINTMENT;TOPICAL

CORTISPORIN

+ MONARCH PHARMS
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000
N050168 002 May 04, 1984

UNITS/GM

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

AT
AKORN
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM

AT
+ BAUSCH AND LOMB
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM

AT
PERRIGO CO TENNESSEE
400 UNITS/GM;EQ 3.5MG BASE;10,000
UNITS/GM

BACITRACIN ZINC; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

BACITRACIN ZINC AND POLYMYXIN B SULFATE

AT
AKORN
500 UNITS/GM;10,000 UNITS/GM
AT
+ BAUSCH AND LOMB
500 UNITS/GM;10,000 UNITS/GM
AT
PERRIGO CO TENNESSEE
500 UNITS/GM;10,000 UNITS/GM

A065088 001 Feb 06, 2004

A064064 001 Oct 30, 1995

A060764 002

A064028 001 Jan 30, 1995

A064046 001 Jan 26, 1995

A065022 001 Feb 27, 2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-42(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

+ PERRIGO CO TENNESSEE
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
A062166 002

UNITS/GM

BACLOFEN

INJECTABLE;INTRATHECAL

GABLOFEN

AP
MALLINCKRODT INC
AP
AP
LIORESAL

AP
+ MEDTRONIC NEURO
AP
+
AP
+
GABLOFEN

MALLINCKRODT INC
TABLET;ORAL

BACLOFEN

AB
CARACO
AB
IMPAX LABS
AB
AB
IVAX SUB TEVA PHARMS
AB
+
AB
LANNETT
AB
AB
MYLAN
AB
AB
MYLAN PHARMS INC
AB
AB
NORTHSTAR HLTHCARE
AB
AB
PROSAM LABS
AB
AB
SUN PHARM INDS INC
AB
USL PHARMA
AB
AB
VINTAGE PHARMS
AB
AB
WATSON LABS
AB
BALSALAZIDE DISODIUM

CAPSULE;ORAL

BALSALAZIDE DISODIUM

AB
APOTEX INC
AB
MYLAN
AB
ROXANE
COLAZAL

AB
+ VALEANT PHARMS INTL
TABLET;ORAL

BALSALAZIDE DISODIUM

AB
PAR PHARM INC
GIAZO

AB
+ VALEANT PHARMS INTL

0.05MG/ML
0.5MG/ML
2MG/ML

N022462 001 Nov 19, 2010

N022462 002 Nov 19, 2010

N022462 003 Nov 19, 2010

0.05MG/ML
0.5MG/ML
2MG/ML

N020075 003 Nov 07, 1996

N020075 001 Jun 17, 1992

N020075 002 Jun 17, 1992

1MG/ML

N022462 004 Jun 22, 2012

10MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG

A077984
A078146
A077971
A072234
A072235
A078220
A077241
A077181
A077121
A090334
A090334
A078504
A078401
A077089
A077088
A077862
A074584
A074584
A077156
A077068
A072824
A072825

750MG
750MG
750MG

A077883 001 Dec 28, 2007

A077807 001 Dec 28, 2007

A077806 001 Dec 28, 2007

750MG

N020610 001 Jul 18, 2000

1.1GM

A206336 001 Sep 08, 2015

1.1GM

N022205 001 Feb 03, 2012

BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

TABLET;ORAL

DUAVEE

+ WYETH PHARMS PFIZER
EQ 20MG BASE;0.45MG
BECLOMETHASONE DIPROPIONATE

AEROSOL, METERED;INHALATION

QVAR 40

+ TEVA BRANDED PHARM
QVAR 80

+ TEVA BRANDED PHARM
AEROSOL, METERED;NASAL

QNASL

TEVA BRANDED PHARM
+

001
001
002
001
001
001
001
001
002
001
002
001
001
001
001
002
001
002
001
001
001
001

Aug
Oct
Oct
Jul
Jul
Jul
Dec
Jul
Jul
Feb
Feb
Sep
Sep
Oct
Oct
Aug
Aug
Aug
Aug
Aug
Sep
Sep

14,
26,
26,
21,
21,
06,
20,
29,
29,
18,
18,
18,
18,
31,
31,
14,
19,
19,
30,
30,
18,
18,

2006

2007

2007

1988

1988

2007

2005

2005

2005

2010

2010

2009

2009

2007

2007

2006

1996

1996

2005

2005

1991

1991

N022247 001 Oct 03, 2013

0.04MG/INH

N020911 002 Sep 15, 2000

0.08MG/INH

N020911 001 Sep 15, 2000

0.04MG/ACTUATION
0.08MG/ACTUATION

N202813 002 Dec 17, 2014

N202813 001 Mar 23, 2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-43(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED;NASAL

BECONASE AQ

+ GLAXOSMITHKLINE

EQ 0.042MG DIPROP/SPRAY

N019389 001 Jul 27, 1987

BEDAQUILINE FUMARATE

TABLET;ORAL

SIRTURO

+ JANSSEN THERAP

EQ 100MG BASE

N204384 001 Dec 28, 2012

BELINOSTAT

POWDER;IV (INFUSION)

BELEODAQ

+ SPECTRUM PHARMS

500MG/VIAL

N206256 001 Jul 03, 2014

5MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

5MG

10MG

20MG

40MG

A076267
A076267
A076267
A076267
A076820
A076820
A076820
A076820
A077128
A077128
A077128
A077128
A078212
A078212
A078212
A076333
A076333
A076333
A076333
A076430
A076430
A076430
A076430
A076118
A076118
A076118
A076118
A076402
A076402
A076402
A076402
A076344
A076344
A076344
A076344
A076211
A076211
A076211
A076211
A078848
A078848
A078848
A078848

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar
May
May
May
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
May
May
May
May

11,
11,
11,
11,
03,
03,
03,
03,
08,
08,
08,
08,
22,
22,
22,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
23,
23,
23,
23,

2004

2004

2004

2004

2006

2006

2006

2006

2006

2006

2006

2006

2008

2008

2008

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2008

2008

2008

2008

5MG

10MG

20MG

40MG

N019851
N019851
N019851
N019851

001
002
003
004

Jun
Jun
Jun
Jun

25,
25,
25,
25,

1991

1991

1991

1991

A076342
A076342
A076342
A076342

001
002
003
004

Feb
Feb
Feb
Feb

11,
11,
11,
11,

2004

2004

2004

2004

BENAZEPRIL HYDROCHLORIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE
AB
ACTAVIS LABS FL INC
AB
AB
AB
AB
AMNEAL PHARMS LLC
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
PRINSTON INC
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
LOTENSIN
AB
US PHARMS HOLDINGS I
AB
AB
AB
+

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AB
ACTAVIS LABS FL INC
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-44(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AB
APOTEX INC
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
AB
IVAX SUB TEVA PHARMS
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
AB
MYLAN
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
AB
SANDOZ
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
AB
SUN PHARM INDS LTD
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
LOTENSIN HCT

AB
US PHARMS HOLDINGS I
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
+
20MG;25MG
BENDAMUSTINE HYDROCHLORIDE

POWDER;IV (INFUSION)

TREANDA

+ CEPHALON
+
SOLUTION;IV (INFUSION)

BENDEKA

EAGLE PHARMS
TREANDA

+ CEPHALON
+

A078794
A078794
A078794
A078794
A076348
A076348
A076348
A076348
A076688
A076688
A076688
A076688
A076631
A076631
A076631
A076631
A077483
A077483
A077483
A077483

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Aug
Aug
Aug
Aug
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Sep
Sep
Sep
Sep

21,
21,
21,
21,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
08,
08,
08,
08,

2014

2014

2014

2014

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2005

2005

2005

2005

N020033
N020033
N020033
N020033

001
002
004
003

May
May
May
May

19,
19,
19,
19,

1992

1992

1992

1992

25MG/VIAL
100MG/VIAL

N022249 002 May 01, 2009

N022249 001 Mar 20, 2008

100MG/4ML (25MG/ML)

N208194 001 Dec 07, 2015

45MG/0.5ML (90MG/ML)
180MG/2ML (90MG/ML)

N022249 003 Sep 13, 2013

N022249 004 Sep 13, 2013

BENDROFLUMETHIAZIDE; NADOLOL

TABLET;ORAL

CORZIDE

AB
KING PHARMS
5MG;40MG
AB
+
5MG;80MG
NADOLOL AND BENDROFLUMETHIAZIDE

AB
IMPAX LABS
5MG;40MG
AB
5MG;80MG
AB
MYLAN
5MG;40MG
AB
5MG;80MG

A077833
A077833
A078688
A078688

001
002
001
002

Mar
Mar
Feb
Feb

30,
30,
15,
15,

2007

2007

2008

2008

BENZONATATE

CAPSULE;ORAL

BENZONATATE

AA
APOTEX INC
AA
AA
BANNER LIFE SCIENCES
AA
AA
CSPC NBP PHARM CO
AA
MIKART
AA
AA
ORIT LABS LLC
AA
AA
AA
STRIDES PHARMA
AA
AA
SUN PHARM INDS INC
AA
AA
+ THE PHARMA NETWORK
AA
+
AA
+ THEPHARMANETWORK LLC
AA
ZYDUS PHARMS USA
AA

A091310
A091310
A081297
A081297
A202765
A040851
A040851
A040851
A040682
A040682
A091133
A091133
A040587
A040587
A040627
A040749
A201209
A040597
A040597

001
002
001
002
001
001
002
003
001
002
001
002
001
002
001
001
001
001
002

Jan
Jan
Jan
Oct
Jul
Nov
Nov
Nov
Jul
Jul
Jul
Jul
Mar
Mar
Mar
Jul
Sep
Jun
Jun

16,
16,
29,
30,
31,
09,
09,
09,
30,
30,
30,
30,
19,
19,
30,
25,
24,
08,
08,

2015

2015

1993

2007

2015

2009

2009

2009

2007

2007

2015

2015

2008

2008

2007

2007

2014

2007

2007

100MG
200MG
100MG
200MG
200MG
100MG
150MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
150MG
100MG
200MG

N018647 001 May 25, 1983

N018647 002 May 25, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-45(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BENZONATATE

CAPSULE;ORAL

TESSALON

AA
PFIZER

100MG

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

GEL;TOPICAL

ACANYA

AB
+ DOW PHARM
2.5%;EQ 1.2% BASE
BENZACLIN

AB
+ VALEANT BERMUDA
5%;EQ 1% BASE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

AB
ACTAVIS LABS UT INC
2.5%;EQ 1.2% BASE
AB
MYLAN PHARMS INC
5%;EQ 1% BASE
AB
PERRIGO ISRAEL
5%;EQ 1% BASE
AB
5%;1.2%
DUAC

AB
+ STIEFEL
5%;1.2%
ONEXTON

+ DOW PHARM
3.75%;EQ 1.2% BASE

N011210 001

N050819 001 Oct 23, 2008

N050756 001 Dec 21, 2000

A205128
A065443
A202440
A090979

001
001
001
001

Jun
Aug
Sep
Jun

19,
11,
21,
26,

2015

2009

2015

2012

N050741 001 Aug 26, 2002

N050819 002 Nov 24, 2014

BENZOYL PEROXIDE; ERYTHROMYCIN

GEL;TOPICAL

BENZAMYCIN

AB
+ VALEANT INTL
5%;3%
ERYTHROMYCIN AND BENZOYL PEROXIDE

AB
LYNE
5%;3%
AB
TOLMAR
5%;3%
BENZAMYCIN PAK

+ VALEANT LUXEMBOURG
5%;3%

N050769 001 Nov 27, 2000

BENZPHETAMINE HYDROCHLORIDE

TABLET;ORAL

BENZPHETAMINE HYDROCHLORIDE

AA
EMCURE PHARMS LTD
50MG
AA
EPIC PHARMA LLC
50MG
AA
IMPAX LABS
50MG
AA
+ KVK TECH
50MG
AA
MALLINCKRODT INC
50MG
AA
MIKART
25MG
AA
50MG
AA
PADDOCK
50MG
AA
TEDOR PHARM
25MG
AA
50MG

A202061
A090346
A040845
A090968
A040773
A090473
A090473
A040578
A040747
A040747

001
001
001
001
001
001
002
001
002
001

Jan
Dec
Nov
Jul
Apr
Sep
Sep
Apr
Nov
Mar

27,
15,
18,
20,
25,
15,
15,
17,
20,
30,

2012

2015

2008

2010

2007

2010

2010

2006

2015

2007

1MG/ML
1MG/ML
1MG/ML
1MG/ML

A090233
A090287
A091152
A091525

001
001
001
001

Jul
Aug
Mar
Feb

28,
31,
29,
05,

2009

2009

2010

2013

1MG/ML

N012015 001

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG

A072264
A072265
A072266
A090294
A090294
A090294
A090168
A090168
A090168
A204713
A204713
A204713
A089058
A089059
A089060
A040103
A040103
A040103

Feb
Feb
Feb
Mar
Mar
Mar
Nov
Nov
Nov
Apr
Apr
Apr
Aug
Aug
Aug
Dec
Dec
Dec

27,
27,
27,
29,
29,
29,
28,
28,
28,
14,
14,
14,
10,
10,
10,
12,
12,
12,

1989

1989

1989

2010

2010

2010

2012

2012

2012

2015

2015

2015

1988

1988

1988

1996

1996

1996

BENZTROPINE MESYLATE

INJECTABLE;INJECTION

BENZTROPINE MESYLATE

AP
FRESENIUS KABI USA
AP
HIKMA FARMACEUTICA
AP
LUITPOLD
AP
NAVINTA LLC
COGENTIN

AP
+ OAK PHARMS AKORN
TABLET;ORAL

BENZTROPINE MESYLATE

AA
COREPHARMA
AA
AA
AA
INVAGEN PHARMS
AA
AA
AA
LEADING PHARMA LLC
AA
AA
AA
NUVO PHARM INC
AA
AA
AA
PLIVA
AA
AA
AA
+ USL PHARMA
AA
+
AA
+

N050557 001 Oct 26, 1984

A065385 001 Sep 18, 2015

A065112 001 Mar 29, 2004

001
001
001
001
002
003
001
002
003
001
002
003
001
001
001
001
002
003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-46(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BENZTROPINE MESYLATE

TABLET;ORAL

BENZTROPINE MESYLATE

AA
VINTAGE
AA
AA

0.5MG
1MG
2MG

A040738 001 Aug 27, 2007

A040742 001 Aug 27, 2007

A040715 003 Aug 27, 2007

BENZYL ALCOHOL

LOTION;TOPICAL

ULESFIA

+ SHIONOGI INC

5%

N022129 001 Apr 09, 2009

BENZYLPENICILLOYL POLYLYSINE

INJECTABLE;INJECTION

PRE-PEN

+ ALLERQUEST

60UMOLAR

N050114 001

BEPOTASTINE BESILATE

SOLUTION/DROPS;OPHTHALMIC

BEPREVE

+ BAUSCH AND LOMB INC

1.5%

N022288 001 Sep 08, 2009

BERACTANT

SUSPENSION;INTRATRACHEAL

SURVANTA

+ ABBVIE

25MG/ML

N020032 001 Jul 01, 1991

BESIFLOXACIN HYDROCHLORIDE

SUSPENSION/DROPS;OPHTHALMIC

BESIVANCE

+ BAUSCH AND LOMB

EQ 0.6% BASE

N022308 001 May 28, 2009

BETAINE HYDROCHLORIDE

FOR SOLUTION;ORAL

CYSTADANE

+ RARE DIS THERAP

1GM/SCOOPFUL

N020576 001 Oct 25, 1996

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE

AB
LUITPOLD
3MG/ML;EQ 3MG BASE/ML
CELESTONE SOLUSPAN

AB
+ MERCK SHARP DOHME
3MG/ML;EQ 3MG BASE/ML
BETAMETHASONE DIPROPIONATE

CREAM;TOPICAL

BETAMETHASONE DIPROPIONATE

AB
ACTAVIS MID ATLANTIC
AB
+ FOUGERA PHARMS
AB
TARO
CREAM, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

AB
FOUGERA PHARMS
AB
GLENMARK GENERICS
AB
PERRIGO NEW YORK
AB
TARO
AB
TOLMAR
DIPROLENE AF

AB
+ MERCK SHARP DOHME
GEL, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

AB
+ FOUGERA PHARMS
AB
TARO
LOTION;TOPICAL

BETAMETHASONE DIPROPIONATE

AB
ACTAVIS MID ATLANTIC
AB
+ FOUGERA
AB
G AND W LABS INC
AB
PERRIGO NEW YORK
LOTION, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

AB
FOUGERA PHARMS
AB
TARO
DIPROLENE

AB
+ MERCK SHARP DOHME

A090747 001 Jul 31, 2009

N014602 001

EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE

A070885 001 Feb 03, 1987

N019137 001 Jun 26, 1984

A073552 001 Apr 30, 1992

EQ
EQ
EQ
EQ
EQ

A076215
A078930
A076592
A076543
A076603

0.05%
0.05%
0.05%
0.05%
0.05%

BASE
BASE
BASE
BASE
BASE

001
001
001
001
001

Dec
Sep
Dec
Dec
Jan

09,
23,
09,
09,
23,

2003

2008

2003

2003

2004

EQ 0.05% BASE

N019555 001 Apr 27, 1987

EQ 0.05% BASE
EQ 0.05% BASE

A075276 001 May 13, 2003

A076508 001 Dec 02, 2003

EQ
EQ
EQ
EQ

A070281
A070275
A071467
A072538

0.05%
0.05%
0.05%
0.05%

BASE
BASE
BASE
BASE

001
001
001
001

Jul
Aug
Aug
Jan

31,
12,
10,
31,

1985

1985

1987

1990

EQ 0.05% BASE
EQ 0.05% BASE

A077111 001 May 21, 2007

A077477 001 May 21, 2007

EQ 0.05% BASE

N019716 001 Aug 01, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-47(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BETAMETHASONE DIPROPIONATE

OINTMENT;TOPICAL

BETAMETHASONE DIPROPIONATE

AB
ACTAVIS MID ATLANTIC
AB
+ FOUGERA
AB
TARO
OINTMENT, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

AB
ACTAVIS MID ATLANTIC
AB
FOUGERA PHARMS
AB
TARO
DIPROLENE

AB
+ MERCK SHARP DOHME

EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE

A071012 001 Feb 03, 1987

N019141 001 Sep 04, 1984

A074271 001 Sep 15, 1994

EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE

A074304 001 Aug 31, 1995

A075373 001 Jun 22, 1999

A076753 001 Oct 12, 2004

EQ 0.05% BASE

N018741 001 Jul 27, 1983

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

AEROSOL, FOAM;TOPICAL

ENSTILAR

+ LEO PHARMA AS
0.064%;0.005%

N207589 001 Oct 16, 2015

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

OINTMENT;TOPICAL

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

AB
PERRIGO ISRAEL
0.064%;0.005%
AB
TOLMAR
0.064%;0.005%
TACLONEX

AB
+ LEO PHARMA AS
0.064%;0.005%
SUSPENSION;TOPICAL

TACLONEX

+ LEO PHARMA AS
0.064%;0.005%
+
0.064%;0.005%
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

CREAM;TOPICAL

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

AB
ACTAVIS MID ATLANTIC
EQ 0.05% BASE;1%
AB
FOUGERA PHARMS
EQ 0.05% BASE;1%
AB
GLENMARK PHARMS LTD
EQ 0.05% BASE;1%
AB
TARO
EQ 0.05% BASE;1%
LOTRISONE

AB
+ MERCK SHARP DOHME
EQ 0.05% BASE;1%
LOTION;TOPICAL

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

AB
FOUGERA PHARMS
EQ 0.05% BASE;1%
AB
TARO
EQ 0.05% BASE;1%
LOTRISONE

AB
+ MERCK SHARP DOHME
EQ 0.05% BASE;1%
BETAMETHASONE VALERATE

AEROSOL, FOAM;TOPICAL

BETAMETHASONE VALERATE

AB
PERRIGO
LUXIQ

AB
+ DELCOR ASSET
CREAM;TOPICAL

BETA-VAL

AB
G AND W LABS INC
BETAMETHASONE VALERATE

AB
+ FOUGERA
DERMABET

AB
TARO
VALNAC

AB
ACTAVIS MID ATLANTIC
LOTION;TOPICAL

BETA-VAL

AB
G AND W LABS INC
BETAMETHASONE VALERATE

AB
+ FOUGERA
AB
STI PHARMA LLC
OINTMENT;TOPICAL

BETA-VAL

AB
G AND W LABS INC
BETAMETHASONE VALERATE

AB
ACTAVIS MID ATLANTIC
AB
+ FOUGERA

A200174 001 Dec 12, 2014

A201615 001 Jan 14, 2013

N021852 001 Jan 09, 2006

N022185 001 May 09, 2008

N022185 002 Oct 29, 2015

A076002
A075502
A202894
A075673

001
001
001
001

Aug
Jun
Oct
May

02,
05,
30,
29,

2002

2001

2015

2001

N018827 001 Jul 10, 1984

A076516 001 Jun 16, 2005

A076493 001 Jul 28, 2004

N020010 001 Dec 08, 2000

0.12%

A078337 001 Nov 26, 2012

0.12%

N020934 001 Feb 28, 1999

EQ 0.1% BASE

N018642 001 Mar 24, 1983

EQ 0.1% BASE

N018861 001 Aug 31, 1983

EQ 0.1% BASE

A072041 001 Jan 06, 1988

EQ 0.1% BASE

A070050 001 Oct 10, 1984

EQ 0.1% BASE

A070072 001 Jun 27, 1985

EQ 0.1% BASE
EQ 0.1% BASE

N018866 001 Aug 31, 1983

A070052 001 Jul 31, 1985

EQ 0.1% BASE

A070069 001 Dec 19, 1985

EQ 0.1% BASE
EQ 0.1% BASE

A070051 001 Oct 10, 1984

N018865 001 Aug 31, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-48(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BETAXOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

BETAXOLOL HYDROCHLORIDE

AT
AKORN
AT
IGI LABS INC
AT
WOCKHARDT
BETOPTIC

AT
+ ALCON
SUSPENSION/DROPS;OPHTHALMIC

BETOPTIC S

+ ALCON
TABLET;ORAL

BETAXOLOL HYDROCHLORIDE

AB
EPIC PHARMA
AB
+
AB
KVK TECH
AB
BETHANECHOL CHLORIDE

TABLET;ORAL

BETHANECHOL CHLORIDE

AA
AMNEAL PHARM
AA
AA
AA
AA
HERITAGE PHARMA
AA
AA
AA
AA
IMPAX LABS
AA
AA
AA
AA
LANNETT
AA
AA
LANNETT HOLDINGS INC
AA
AA
PHARMAX
AA
AA
AA
AA
SUN PHARM INDS INC
AA
AA
AA
AA
UPSHER SMITH
AA
AA
AA
AA
WOCKHARDT
AA
AA
AA
DUVOID

AA
WELLSPRING PHARM
AA
AA
URECHOLINE

AA
+ ODYSSEY PHARMS
AA
+
AA
+
AA
+
BEXAROTENE

CAPSULE;ORAL

BEXAROTENE

AB
BIONPHARMA INC
TARGRETIN

AB
+ VALEANT LUXEMBOURG
GEL;TOPICAL

TARGRETIN

+ VALEANT LUXEMBOURG

EQ 0.5% BASE
EQ 0.5% BASE
EQ 0.5% BASE

A075386 001 Jun 30, 2000

A075630 001 Apr 12, 2001

A078694 001 Nov 16, 2009

EQ 0.5% BASE

N019270 001 Aug 30, 1985

EQ 0.25% BASE

N019845 001 Dec 29, 1989

10MG
20MG
10MG
20MG

A075541
A075541
A078962
A078962

001
002
001
002

Oct
Oct
Jun
Jun

22,
22,
27,
27,

1999

1999

2008

2008

5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
10MG
25MG
5MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG

A040855
A040855
A040855
A040855
A091256
A091256
A091256
A091256
A040739
A040741
A040740
A040721
A040704
A040678
A040703
A040677
A040725
A040726
A040727
A040728
A040897
A040897
A040897
A040897
A040633
A040634
A040635
A040636
A040532
A040533
A040534
A040518

001
002
003
004
001
002
003
004
001
001
001
004
001
003
001
001
001
001
001
001
001
002
003
004
001
001
001
001
001
001
001
001

Nov
Nov
Nov
Nov
May
May
May
May
Nov
Nov
Nov
Nov
Mar
Mar
Mar
Mar
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep

21,
21,
21,
21,
04,
04,
04,
04,
01,
01,
01,
01,
27,
27,
27,
27,
26,
26,
26,
26,
22,
22,
22,
22,
01,
01,
01,
01,
29,
29,
29,
29,

2007

2007

2007

2007

2010

2010

2010

2010

2006

2006

2006

2006

2008

2008

2008

2008

2007

2007

2007

2007

2009

2009

2009

2009

2005

2005

2005

2005

2003

2003

2003

2003

10MG
25MG
50MG

A086262 001

A086263 001

A085882 003

5MG
10MG
25MG
50MG

A089095
A088440
A088441
A089096

Dec
May
May
Dec

19,
29,
29,
19,

1985

1984

1984

1985

75MG

A203174 001 Aug 12, 2014

75MG

N021055 001 Dec 29, 1999

1%

N021056 001 Jun 28, 2000

001
001
001
001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-49(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BICALUTAMIDE

TABLET;ORAL

BICALUTAMIDE

AB
ACCORD HLTHCARE
AB
ACTAVIS TOTOWA
AB
APOTEX INC
AB
FRESENIUS KABI ONCOL
AB
MYLAN
AB
SANDOZ
AB
STASON PHARMS
AB
SUN PHARMA GLOBAL
AB
TEVA
AB
ZYDUS PHARMS USA INC
CASODEX

AB
+ ASTRAZENECA
BIMATOPROST

SOLUTION/DROPS;OPHTHALMIC

BIMATOPROST

AT
ALCON RES LTD
AT
APOTEX INC
AT
+ LUPIN LTD
LUMIGAN
+ ALLERGAN
SOLUTION/DROPS;TOPICAL
BIMATOPROST
AT
APOTEX INC
LATISSE
AT
+ ALLERGAN

50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG

A078917
A078634
A200274
A079045
A079185
A078575
A091011
A079110
A076932
A079089

001
001
001
001
001
001
001
001
001
001

50MG

N020498 001 Oct 04, 1995

0.03%
0.03%
0.03%

A202565 001 May 05, 2015

A090449 001 Jul 20, 2015
A203991 001 Feb 20, 2015

0.01%

N022184 001 Aug 31, 2010

0.03%

A201894 001 Dec 01, 2014

0.03%

N022369 001 Dec 24, 2008

Jul
Aug
May
May
Jul
Jul
Jun
Jul
Jul
Jul

06,
28,
21,
13,
06,
06,
10,
06,
06,
06,

2009

2009

2015

2010

2009

2009

2015

2009

2009

2009

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL

+ NOVEL LABS INC
5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM
A202217 001 Aug 20, 2014

;N/A,5.6GM

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE

CAPSULE;ORAL

PYLERA

+ FOREST LABS LLC
140MG;125MG;125MG
BISOPROLOL FUMARATE

TABLET;ORAL

BISOPROLOL FUMARATE

AB
AUROBINDO PHARMA
AB
AB
MYLAN
AB
AB
SANDOZ
AB
AB
TEVA PHARMS
AB
AB
UNICHEM PHARMS (USA)
AB
ZEBETA

AB
TEVA WOMENS
AB
+

N050786 001 Sep 28, 2006

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A077910
A077910
A075831
A075831
A075643
A075643
A075644
A075644
A078635
A078635

5MG
10MG

N019982 002 Jul 31, 1992

N019982 001 Jul 31, 1992

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

AB
MYLAN
2.5MG;6.25MG
AB
5MG;6.25MG
AB
10MG;6.25MG
AB
SANDOZ
2.5MG;6.25MG
5MG;6.25MG
AB
AB
10MG;6.25MG
AB
UNICHEM
2.5MG;6.25MG
AB
5MG;6.25MG
AB
10MG;6.25MG
ZIAC

AB
TEVA WOMENS
2.5MG;6.25MG
AB
5MG;6.25MG
AB
+
10MG;6.25MG

A075768
A075768
A075768
A075579
A075579
A075579
A079106
A079106
A079106

001
002
001
002
001
002
001
002
001
002

001
002
003
001
002
003
001
002
003

Dec
Dec
Dec
Dec
Nov
Nov
Jun
Jun
Aug
Aug

Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul

27,
27,
14,
14,
16,
16,
26,
26,
18,
18,

25,
25,
25,
25,
25,
25,
28,
28,
28,

2006

2006

2005

2005

2000

2000

2001

2001

2009

2009

2000

2000

2000

2000

2000

2000

2010

2010

2010

N020186 003 Mar 26, 1993

N020186 001 Mar 26, 1993

N020186 002 Mar 26, 1993

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-50(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BIVALIRUDIN

INJECTABLE;INTRAVENOUS

ANGIOMAX

AP
+ THE MEDICINES CO
BIVALIRUDIN

AP
HOSPIRA INC
AP

250MG/VIAL

N020873 001 Dec 15, 2000

250MG/VIAL
250MG/VIAL

A090811 001 Jul 14, 2015

A090816 001 Jul 14, 2015

BLEOMYCIN SULFATE

INJECTABLE;INJECTION

BLEOMYCIN SULFATE

AP
EUROHLTH INTL SARL
AP
AP
+ FRESENIUS KABI USA
AP
+
AP
HOSPIRA
AP
AP
TEVA PHARMS USA
AP

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BOCEPREVIR

CAPSULE;ORAL

VICTRELIS

+ MERCK SHARP DOHME

200MG

15
30
15
30
15
30
15
30

UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

A065042
A065042
A065185
A065185
A065031
A065031
A065033
A065033

002
001
001
002
001
002
001
002

Oct
Oct
Jan
Jan
Mar
Mar
Jun
Jun

17,
17,
28,
28,
10,
10,
27,
27,

2001

2001

2008

2008

2000

2000

2000

2000

N202258 001 May 13, 2011

BORTEZOMIB

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

VELCADE

+ MILLENNIUM PHARMS
3.5MG/VIAL

N021602 001 May 13, 2003

BOSENTAN

TABLET;ORAL

TRACLEER

ACTELION PHARMS LTD
+

62.5MG
125MG

N021290 001 Nov 20, 2001

N021290 002 Nov 20, 2001

EQ 100MG BASE
EQ 500MG BASE

N203341 001 Sep 04, 2012

N203341 002 Sep 04, 2012

BOSUTINIB MONOHYDRATE

TABLET;ORAL

BOSULIF

+ WYETH PHARMS INC

BRETYLIUM TOSYLATE

INJECTABLE;INJECTION

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

+ B BRAUN
100MG/100ML
+
200MG/100ML
+
400MG/100ML
BREXPIPRAZOLE

TABLET;ORAL

REXULTI

OTSUKA PHARM CO LTD

+
BRIMONIDINE TARTRATE

GEL;TOPICAL

MIRVASO

+ GALDERMA LABS LP
SOLUTION/DROPS;OPHTHALMIC

ALPHAGAN P

AT
+ ALLERGAN
BRIMONIDINE TARTRATE

AT
AKORN
AT
ALCON PHARMS LTD
AT
+ BAUSCH AND LOMB
AT
INDOCO REMEDIES
AT
SANDOZ
QOLIANA

AT
ALCON PHARMS LTD
ALPHAGAN P

+ ALLERGAN

N019121 001 Apr 29, 1986

N019121 002 Apr 29, 1986

N019121 003 Apr 29, 1986

0.25MG
0.5MG
1MG
2MG
3MG
4MG

N205422
N205422
N205422
N205422
N205422
N205422

001
002
003
004
005
006

EQ 0.33% BASE

N204708 001 Aug 23, 2013

0.15%

N021262 001 Mar 16, 2001

0.2%
0.2%
0.2%
0.2%
0.2%

A076439
A076254
A076260
A091691
A078075

0.15%

N021764 001 May 22, 2006

0.1%

N021770 001 Aug 19, 2005

001
001
001
001
001

Jul
Jul
Jul
Jul
Jul
Jul

Mar
Sep
May
Nov
Jan

10,
10,
10,
10,
10,
10,

14,
16,
28,
18,
30,

2015

2015

2015

2015

2015

2015

2006

2003

2003

2014

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-51(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BRIMONIDINE TARTRATE; BRINZOLAMIDE

SUSPENSION/DROPS;OPHTHALMIC

SIMBRINZA

+ ALCON RES LTD
0.2%;1%

N204251 001 Apr 19, 2013

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

COMBIGAN

+ ALLERGAN
0.2%;EQ 0.5% BASE

N021398 001 Oct 30, 2007

BRINZOLAMIDE

SUSPENSION/DROPS;OPHTHALMIC

AZOPT

+ ALCON PHARMS LTD

N020816 001 Apr 01, 1998

BROMFENAC SODIUM

SOLUTION/DROPS;OPHTHALMIC

BROMFENAC SODIUM

AT1
APOTEX INC
AT1 + COASTAL PHARMS
AT1
LUITPOLD
AT1
PADDOCK LLC
AT2
APOTEX INC
AT2
HI-TECH PHARMACAL
PROLENSA
+ BAUSCH AND LOMB
BROMOCRIPTINE MESYLATE

CAPSULE;ORAL

BROMOCRIPTINE MESYLATE

AB
MYLAN
AB
ZYDUS PHARMS USA INC
PARLODEL

AB
+ US PHARMS HOLDINGS I
TABLET;ORAL

BROMOCRIPTINE MESYLATE

AB
LEK PHARMS
AB
MYLAN
AB
PADDOCK LLC
PARLODEL

AB
+ US PHARMS HOLDINGS I
CYCLOSET

+ VEROSCIENCE

1%

EQ
EQ
EQ
EQ
EQ
EQ

0.09%
0.09%
0.09%
0.09%
0.09%
0.09%

ACID
ACID
ACID
ACID
ACID
ACID

A202435
A201211
A202030
A201941
A202620
A203395

001
001
001
001
001
001

Jun
May
Jan
Feb
Jun
Jan

19,
11,
09,
10,
23,
22,

2014
2011
2013
2015
2014
2014

EQ 0.07% ACID

N203168 001 Apr 05, 2013

EQ 5MG BASE
EQ 5MG BASE

A077226 001 Apr 04, 2005

A078899 001 Jul 30, 2008

EQ 5MG BASE

N017962 002 Mar 01, 1982

EQ 2.5MG BASE
EQ 2.5MG BASE
EQ 2.5MG BASE

A074631 001 Jan 13, 1998

A076962 001 Sep 24, 2004

A077646 001 Oct 01, 2008

EQ 2.5MG BASE

N017962 001

EQ 0.8MG BASE

N020866 001 May 05, 2009

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP;ORAL

BROMFED-DM

AA
+ WOCKHARDT
2MG/5ML;10MG/5ML;30MG/5ML
A088811 001 Jun 07, 1985

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

AA
PADDOCK LLC
2MG/5ML;10MG/5ML;30MG/5ML
A205292 001 Jul 15, 2014

AA
VINTAGE PHARMS
2MG/5ML;10MG/5ML;30MG/5ML
A202940 001 Jul 21, 2014

BUDESONIDE

AEROSOL, FOAM;RECTAL

UCERIS

+ VALEANT PHARMS INTL
CAPSULE;ORAL

BUDESONIDE

AB
BARR LABS DIV TEVA
AB
MYLAN
ENTOCORT EC

AB
+ ASTRAZENECA
POWDER, METERED;INHALATION

PULMICORT FLEXHALER

ASTRAZENECA
+
SPRAY, METERED;NASAL

BUDESONIDE

APOTEX INC
SUSPENSION;INHALATION

BUDESONIDE

AN
SANDOZ INC
AN
AN
AN
TEVA PHARMS

2MG/ACTUATION

N205613 001 Oct 07, 2014

3MG
3MG

A090379 001 Apr 02, 2014

A090410 001 May 16, 2011

3MG

N021324 001 Oct 02, 2001

0.08MG/INH
0.16MG/INH

N021949 001 Jul 12, 2006

N021949 002 Jul 12, 2006

0.032MG/INH

A078949 001 May 12, 2014

0.25MG/2ML
0.5MG/2ML
1MG/2ML
0.25MG/2ML

A201966
A201966
A201966
A077519

003
002
001
001

Sep
Sep
Sep
Nov

27,
27,
27,
18,

2013

2013

2013

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-52(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BUDESONIDE

SUSPENSION;INHALATION

BUDESONIDE

AN
0.5MG/2ML
AN
WATSON LABS INC
0.25MG/2ML
AN
0.5MG/2ML
PULMICORT RESPULES

AN
ASTRAZENECA PHARMS
0.25MG/2ML
AN
0.5MG/2ML
AN
+
1MG/2ML
TABLET, EXTENDED RELEASE;ORAL

UCERIS

+ VALEANT PHARMS INTL
9MG
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

AEROSOL, METERED;INHALATION

SYMBICORT

+ ASTRAZENECA
0.08MG/INH;0.0045MG/INH
+
0.16MG/INH;0.0045MG/INH
BUMETANIDE

INJECTABLE;INJECTION

BUMETANIDE

AP
+ BEDFORD
AP
EUROHLTH INTL SARL
AP
HOSPIRA
TABLET;ORAL

BUMETANIDE

AB
IVAX SUB TEVA PHARMS
AB
AB
AB
SANDOZ
AB
AB
+
BUMEX

AB
VALIDUS PHARMS INC
AB
AB

A077519 002 Nov 18, 2008

A078404 001 Jul 31, 2012

A078404 002 Jul 31, 2012

N020929 001 Aug 08, 2000

N020929 002 Aug 08, 2000

N020929 003 Aug 08, 2000

N203634 001 Jan 14, 2013

N021929 001 Jul 21, 2006

N021929 002 Jul 21, 2006

0.25MG/ML
0.25MG/ML
0.25MG/ML

A074441 001 Jan 27, 1995

A079196 001 Apr 30, 2008

A074332 001 Oct 31, 1994

0.5MG
1MG
2MG
0.5MG
1MG
2MG

A074225
A074225
A074225
A074700
A074700
A074700

0.5MG
1MG
2MG

N018225 002 Feb 28, 1983

N018225 001 Feb 28, 1983

N018225 003 Jun 14, 1985

BUPIVACAINE

INJECTABLE, LIPOSOMAL;INJECTION

EXPAREL

+ PACIRA PHARMS INC
266MG/20ML (13.3MG/ML)
BUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE

AP
HOSPIRA
0.25%
AP
0.25%
AP
0.25%
AP
0.25%
AP
0.5%
AP
0.5%
AP
0.5%
AP
0.5%
AP
0.75%
AP
0.75%
AP
SAGENT AGILA
0.25%
AP
0.5%
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

AP
AUROBINDO PHARMA LTD
0.25%
AP
0.5%
AP
0.75%
AP
SAGENT AGILA
0.25%
AP
0.5%
AP
0.75%
MARCAINE HYDROCHLORIDE

AP
+ HOSPIRA
0.25%
AP
+
0.5%
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE

AP
+ HOSPIRA
0.25%
AP
+
0.5%
AP
+
0.75%

001
002
003
001
002
003

Apr
Apr
Apr
Nov
Nov
Nov

24,
24,
24,
21,
21,
21,

1995

1995

1995

1996

1996

1996

N022496 002 Oct 28, 2011

A070583
A070586
A070590
N018053
A070584
A070597
A070609
N018053
A070585
N018053
A091503
A091503

001
001
001
002

001
001
001
001

001
003

001
002

Feb 17, 1987

Mar 03, 1987

Feb 17, 1987

A203895
A203895
A203895
A091487
A091487
A091487

001
002
003
002
001
003

Nov
Nov
Nov
Oct
Oct
Oct

N016964 001

N016964 006

N016964 012

N016964 005

N016964 009

Feb 17, 1986

Mar 03, 1987

Mar 03, 1987

Mar 03, 1987

Oct 18, 2011

Oct 18, 2011

05,
05,
05,
18,
18,
18,

2013

2013

2013

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-53(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

SENSORCAINE

AP
FRESENIUS KABI USA
AP
AP
AP
AP
AP
INJECTABLE;SPINAL

BUPIVACAINE HYDROCHLORIDE

AP
HOSPIRA
MARCAINE

AP
+ HOSPIRA
SENSORCAINE

AP
FRESENIUS KABI USA

0.25%
0.25%
0.5%
0.5%
0.75%
0.75%

A070552
N018304
A070553
N018304
A070554
N018304

0.75%

A071810 001 Dec 11, 1987

0.75%

N018692 001 May 04, 1984

0.75%

A071202 001 Apr 15, 1987

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

AP
+ HOSPIRA
0.5%;0.005MG/ML
AP
0.5%;0.005MG/ML
+
0.25%;0.005MG/ML
0.25%;0.005MG/ML
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

AP
SEPTODONT
0.5%;0.0091MG/ML
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE

AP
+ HOSPIRA
0.5%;0.0091MG/ML
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

AP
+ HOSPIRA
0.25%;0.0091MG/ML
AP
+
0.5%;0.0091MG/ML
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE

AP
+ HOSPIRA
0.25%;0.0091MG/ML
AP
+
0.5%;0.0091MG/ML
AP
+
0.75%;0.0091MG/ML
SENSORCAINE

AP
FRESENIUS KABI USA
0.25%;0.0091MG/ML
AP
0.25%;0.0091MG/ML
AP
0.5%;0.0091MG/ML
AP
0.5%;0.0091MG/ML
AP
0.75%;0.0091MG/ML

EQ
EQ
EQ
EQ
EQ
EQ
EQ

+
INJECTABLE;INJECTION

BUPRENEX

AP
+ INDIVIOR INC
EQ
BUPRENORPHINE HYDROCHLORIDE

AP
EUROHLTH INTL SARL
EQ
AP
HOSPIRA
EQ
AP
LUITPOLD
EQ
AP
PAR STERILE PRODUCTS
EQ

001
001
001
001

Jun
Jun
Jun
Jun

16,
16,
16,
16,

1988

1988

1988

1988

A077250 001 Sep 27, 2006

N022046 001 Jul 13, 1983

N016964 004

N016964 008

N016964 013

N016964 007

N016964 010

A070966
A070967
A070968
N018304
N018304

001
001
001
004
005

Oct
Oct
Oct
Sep
Sep

13,
13,
13,
02,
02,

1987

1987

1987

1983

1983

N021306
N021306
N021306
N021306
N021306

001
005
002
004
003

Jun
Jun
Jun
Jul
Jun

30,
30,
30,
25,
30,

2010

2014

2010

2013

2010

0.075MG BASE
0.15MG BASE
0.3MG BASE
0.45MG BASE
0.6MG BASE
0.75MG BASE
0.9MG BASE

N207932
N207932
N207932
N207932
N207932
N207932
N207932

001
002
003
004
005
006
007

Oct
Oct
Oct
Oct
Oct
Oct
Oct

23,
23,
23,
23,
23,
23,
23,

2015

2015

2015

2015

2015

2015

2015

0.3MG BASE/ML

N018401 001

0.3MG
0.3MG
0.3MG
0.3MG

A076931
A074137
A078331
A206586

Mar
Jun
Mar
Jul

02,
03,
27,
28,

2005

1996

2007

2015

BUPRENORPHINE

FILM, EXTENDED RELEASE;TRANSDERMAL

BUTRANS

PURDUE PHARMA LP
5MCG/HR
7.5MCG/HR
10MCG/HR
15MCG/HR
+
20MCG/HR
BUPRENORPHINE HYDROCHLORIDE

FILM;BUCCAL

BELBUCA

ENDO PHARMS INC

A071168
A071170
A071165
A071167

001 May 21, 1986

001

001 May 21, 1986

002

001 May 21, 1986

003

BASE/ML
BASE/ML
BASE/ML
BASE/ML

001
001
001
001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-54(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BUPRENORPHINE HYDROCHLORIDE

TABLET;SUBLINGUAL

BUPRENORPHINE HYDROCHLORIDE

AB
ACTAVIS ELIZABETH
EQ
AB
EQ
AB
BARR
EQ
AB
EQ
AB
ETHYPHARM
EQ
AB
EQ
AB
MYLAN PHARMS INC
EQ
AB
EQ
AB
ROXANE
EQ
AB
+
EQ
AB
SANDOZ INC
EQ
AB
EQ

2MG
8MG
2MG
8MG
2MG
8MG
2MG
8MG
2MG
8MG
2MG
8MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A090819
A090819
A090360
A090360
A090622
A090622
A201066
A201066
A078633
A078633
A090279
A090279

001
002
001
002
001
002
001
002
001
002
001
002

Feb
Feb
May
May
Sep
Sep
Mar
Mar
Oct
Oct
Jun
Jun

19,
19,
07,
07,
24,
24,
06,
06,
08,
08,
10,
10,

2015

2015

2010

2010

2010

2010

2015

2015

2009

2009

2015

2015

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FILM;BUCCAL

BUNAVAIL

BIODELIVERY SCI INTL
EQ 2.1MG BASE;EQ 0.3MG BASE
EQ 4.2MG BASE;EQ 0.7MG BASE
+
EQ 6.3MG BASE;EQ 1MG BASE
FILM;BUCCAL, SUBLINGUAL

SUBOXONE

INDIVIOR INC
EQ 2MG BASE;EQ 0.5MG BASE
EQ 4MG BASE;EQ 1MG BASE
EQ 8MG BASE;EQ 2MG BASE
+
EQ 12MG BASE;EQ 3MG BASE
TABLET;SUBLINGUAL

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

AB
ACTAVIS ELIZABETH
EQ 2MG BASE;EQ 0.5MG BASE
AB
+
EQ 8MG BASE;EQ 2MG BASE
AB
AMNEAL PHARMS
EQ 8MG BASE;EQ 2MG BASE
AB
ETHYPHARM USA CORP
EQ 2MG BASE;EQ 0.5MG BASE
AB
EQ 8MG BASE;EQ 2MG BASE
AB
ROXANE
EQ 2MG BASE;EQ 0.5MG BASE
AB
EQ 8MG BASE;EQ 2MG BASE
AB
TEVA PHARMS USA
EQ 2MG BASE;EQ 0.5MG BASE
AB
EQ 8MG BASE;EQ 2MG BASE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

AB
AMNEAL PHARMS
EQ 2MG BASE;EQ 0.5MG BASE
ZUBSOLV

OREXO AB
EQ 1.4MG BASE;EQ 0.36MG BASE
EQ 2.9MG BASE;EQ 0.71MG BASE
+
EQ 5.7MG BASE;EQ 1.4MG BASE
EQ 8.6MG BASE;EQ 2.1MG BASE
EQ 11.4MG BASE;EQ 2.9MG BASE

N204242
N204242
N204242
N204242
N204242

BUPROPION HYDROBROMIDE

TABLET, EXTENDED RELEASE;ORAL

APLENZIN

VALEANT PHARMS NORTH
174MG
348MG
+
522MG

N022108 001 Apr 23, 2008

N022108 002 Apr 23, 2008

N022108 003 Apr 23, 2008

BUPROPION HYDROCHLORIDE

TABLET;ORAL

BUPROPION HYDROCHLORIDE

AB
APOTEX INC
75MG
AB
100MG
AB
MYLAN
75MG
AB
100MG
AB
SANDOZ
75MG
AB
100MG
WELLBUTRIN

AB
GLAXOSMITHKLINE
75MG
AB
+
100MG
TABLET, EXTENDED RELEASE;ORAL

BUPROPION HYDROCHLORIDE

AB1
ACTAVIS LABS FL INC
100MG
AB1
150MG
AB1
200MG
AB1
ANCHEN PHARMS
100MG
AB1
150MG

N205637 001 Jun 06, 2014

N205637 002 Jun 06, 2014

N205637 003 Jun 06, 2014

N022410
N022410
N022410
N022410

001
003
002
004

Aug
Aug
Aug
Aug

30,
10,
30,
10,

2010

2012

2010

2012

A091422
A091422
A203136
A204431
A204431
A203326
A203326
A091149
A091149

001
002
002
001
002
001
002
001
002

Feb
Feb
Feb
Oct
Oct
Jun
Jun
Sep
Sep

22,
22,
22,
16,
16,
27,
27,
08,
08,

2013

2013

2013

2015

2015

2014

2014

2014

2014

A203136 001 Feb 22, 2013

A076143
A076143
A075491
A075491
A075584
A075584

001
005
002
003
004

001
002
001
002
001
002

Jul
Jun
Jul
Dec
Dec

Jan
Jan
Apr
Apr
Feb
Feb

03,
04,
03,
11,
11,

17,
17,
17,
17,
07,
07,

2013

2015

2013

2014

2014

2006

2006

2000

2000

2000

2000

N018644 002 Dec 30, 1985

N018644 003 Dec 30, 1985

A079095
A079095
A079095
A091459
A091459

001
002
003
001
002

Mar
Mar
Mar
Jun
Jun

24,
24,
24,
09,
09,

2009

2009

2009

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-55(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

BUPROPION HYDROCHLORIDE

AB1

200MG

AB1
IMPAX LABS

100MG

AB1

150MG

AB1

200MG

AB1
JUBILANT GENERICS

100MG

AB1

150MG

AB1

200MG

AB1
MYLAN

100MG

AB1

150MG

AB1

200MG

AB1
PRINSTON INC

100MG

AB1

150MG

AB1

200MG

AB1
SANDOZ

100MG

AB1

150MG

AB1

200MG

AB1
SUN PHARMA GLOBAL

100MG

AB1

150MG

AB1

200MG

AB1
TORRENT PHARMS LTD

100MG

AB1

150MG

AB1

200MG

AB1
WATSON LABS INC

100MG

AB1

150MG

AB1

200MG

WELLBUTRIN SR

AB1
GLAXOSMITHKLINE
100MG

AB1
150MG

AB1 +
200MG

BUPROPION HYDROCHLORIDE
AB2
ACTAVIS LABS FL INC
150MG

AB2
ANCHEN PHARMS
150MG

AB2
IMPAX LABS
150MG

AB2
JUBILANT GENERICS
150MG

AB2
MYLAN
150MG

AB2
SANDOZ INC
150MG

ZYBAN
AB2 + GLAXOSMITHKLINE
150MG

BUPROPION HYDROCHLORIDE
AB3
ACTAVIS LABS FL INC
150MG

AB3
ANCHEN PHARMS
150MG

AB3
300MG

AB3
IMPAX LABS
150MG

AB3
MYLAN
150MG

AB3
300MG

AB3
SUN PHARMA GLOBAL
150MG

AB3
WATSON LABS INC
150MG

AB3
300MG

AB3
WOCKHARDT LTD
150MG

AB3
ZYDUS PHARMS USA INC
300MG

WELLBUTRIN XL
AB3
VALEANT INTL
150MG

AB3 +
300MG

FORFIVO XL
+ EDGEMONT PHARMS LLC
450MG

A091459
A075913
A075913
A076711
A202774
A202774
A202774
A090325
A090325
A090325
A202304
A202304
A202304
A075932
A075932
A075932
A078866
A078866
A078866
A203969
A203969
A203969
A077455
A077455
A077455

003
001
002
001
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jun
Jan
Mar
Dec
Oct
Oct
Oct
Apr
Apr
Apr
May
May
May
Nov
Mar
Jun
Apr
Apr
Apr
Oct
Oct
Oct
Jul
Mar
Jul

09,
28,
22,
03,
11,
11,
11,
08,
08,
08,
26,
26,
26,
25,
22,
22,
06,
06,
06,
31,
31,
31,
19,
12,
19,

2011

2004

2004

2004

2013

2013

2013

2010

2010

2010

2015

2015

2015

2003

2004

2005

2010

2010

2010

2014

2014

2014

2010

2008

2010

N020358 002 Oct 04, 1996

N020358 003 Oct 04, 1996

N020358 004 Jun 14, 2002

A079094
A091520
A075914
A202775
A090941
A077475

001
001
001
001
001
001

Mar
Jun
May
Oct
May
Mar

24,
09,
27,
11,
03,
12,

2009

2011

2004

2013

2010

2008

N020711 003 May 14, 1997

A077715
A077284
A077284
A077415
A090942
A090942
A200695
A077285
A077285
A202189
A201567

001
001
002
001
001
002
001
001
002
001
001

Nov
Dec
Dec
Nov
Jul
Jul
Dec
Nov
Aug
Nov
Jan

26,
14,
14,
26,
14,
14,
18,
26,
15,
21,
17,

2008

2006

2006

2008

2010

2010

2014

2008

2008

2012

2014

N021515 001 Aug 28, 2003

N021515 002 Aug 28, 2003

N022497 001 Nov 10, 2011

BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CONTRAVE
+ TAKEDA PHARMS USA
90MG;8MG

N200063 001 Sep 10, 2014

BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPIRONE HYDROCHLORIDE
AB
ACCORD HLTHCARE
AB
AB
AB
AB
AB
DR REDDYS LABS LTD

A202557
A202557
A202557
A202557
A202557
A078246

5MG
7.5MG
10MG
15MG
30MG
5MG

001
002
003
004
005
001

Dec
Dec
Dec
Dec
Dec
Feb

30,
30,
30,
30,
30,
27,

2014

2014

2014

2014

2014

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-56(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BUSPIRONE HYDROCHLORIDE

TABLET;ORAL

BUSPIRONE HYDROCHLORIDE

AB
AB
AB
AB
EMCURE PHARMS USA
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
AB
AB
ORION CORP ORION
AB
AB
AB
AB
PROSAM LABS
AB
STRIDES ARCOLAB LTD
AB
AB
AB
AB
TEVA
AB
AB
+
AB
AB
WATSON LABS
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
AB
BUSULFAN

INJECTABLE;INJECTION

BUSULFAN

AP
PHARMAFORCE
BUSULFEX

AP
+ OTSUKA PHARM
TABLET;ORAL

MYLERAN

+ ASPEN GLOBAL

10MG
15MG
30MG
5MG
10MG
15MG
30MG
5MG
5MG
7.5MG
10MG
10MG
15MG
15MG
30MG
5MG
10MG
15MG
30MG
30MG
5MG
10MG
15MG
30MG
5MG
10MG
15MG
30MG
5MG
10MG
15MG
5MG
10MG
15MG
30MG

A078246
A078246
A078246
A204582
A204582
A204582
A204582
A075272
A075467
A075467
A075272
A075467
A075272
A075467
A076008
A202087
A202087
A202087
A202087
A078302
A202330
A202330
A202330
A202330
A075022
A075022
A075022
A075022
A074253
A074253
A074253
A078888
A078888
A078888
A078888

002
003
004
001
002
003
004
001
001
002
002
003
003
004
001
001
002
003
004
001
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004

6MG/ML

A202259 001 Dec 22, 2015

6MG/ML

N020954 001 Feb 04, 1999

Feb
Feb
Feb
Sep
Sep
Sep
Sep
Mar
Feb
Mar
Mar
Feb
Mar
Feb
Jun
Dec
Dec
Dec
Dec
Dec
Aug
Aug
Aug
Aug
Feb
Feb
Feb
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb

27,
27,
27,
18,
18,
18,
18,
01,
28,
28,
01,
28,
28,
28,
28,
16,
16,
16,
16,
17,
25,
25,
25,
25,
28,
28,
28,
25,
28,
28,
13,
07,
07,
07,
07,

2009

2009

2009

2015

2015

2015

2015

2002

2002

2001

2002

2002

2001

2002

2001

2015

2015

2015

2015

2007

2014

2014

2014

2014

2002

2002

2002

2004

2001

2001

2002

2014

2014

2014

2014

2MG

N009386 001

BUTABARBITAL SODIUM

TABLET;ORAL

BUTISOL SODIUM

+ MEDA PHARMS

30MG

N000793 004

BUTENAFINE HYDROCHLORIDE

CREAM;TOPICAL

MENTAX

+ MYLAN

1%

N020524 001 Oct 18, 1996

BUTOCONAZOLE NITRATE

CREAM;VAGINAL

GYNAZOLE-1

+ PERRIGO ISRAEL

2%

A200923 001 May 18, 2012

BUTORPHANOL TARTRATE

INJECTABLE;INJECTION

BUTORPHANOL TARTRATE

AP
BEDFORD
2MG/ML
AP
HIKMA FARMACEUTICA
1MG/ML
AP
2MG/ML
BUTORPHANOL TARTRATE PRESERVATIVE FREE

AP
BEDFORD
1MG/ML
AP
2MG/ML
AP
HOSPIRA
1MG/ML
AP
2MG/ML

A075046 001 Aug 12, 1998

A078400 001 May 01, 2009

A078400 002 May 01, 2009

A075045
A075045
A074626
A074626

001
002
001
002

Aug
Aug
Jan
Jan

12,
12,
23,
23,

1998

1998

1997

1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-57(of 388)

PRESCRIPTION DRUG PRODUCT LIST

BUTORPHANOL TARTRATE

SPRAY, METERED;NASAL

BUTORPHANOL TARTRATE

AB
+ MYLAN
AB
NOVEX
AB
ROXANE

1MG/SPRAY
1MG/SPRAY
1MG/SPRAY

A075759 001 Aug 08, 2001

A075499 001 Dec 04, 2002

A075824 001 Mar 12, 2002

CABAZITAXEL

SOLUTION;IV (INFUSION)

JEVTANA KIT

+ SANOFI AVENTIS US

60MG/1.5ML (40MG/ML)

N201023 001 Jun 17, 2010

CABERGOLINE

TABLET;ORAL

CABERGOLINE

AB
ACTAVIS LABS FL INC
AB
APOTEX CORP
AB
IMPAX LABS INC
AB
IVAX SUB TEVA PHARMS
AB
MYLAN PHARMS INC
AB
+ PAR PHARM

0.5MG
0.5MG
0.5MG
0.5MG
0.5MG
0.5MG

A078035
A201503
A077843
A077750
A202947
A076310

CABOZANTINIB S-MALATE

CAPSULE;ORAL

COMETRIQ

EXELIXIS
+

EQ 20MG BASE
EQ 80MG BASE

N203756 001 Nov 29, 2012

N203756 002 Nov 29, 2012

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N020793 001 Sep 21, 1999

EQ
EQ
EQ
EQ
EQ
EQ

A205013
A077233
A077997
A077906
A090827
A090077

CAFFEINE CITRATE

SOLUTION;INTRAVENOUS

CAFCIT

AP
+ EUROHLTH INTL SARL
CAFFEINE CITRATE

AP
AUROBINDO PHARMA LTD
AP
EXELA PHARMA SCIENCE
AP
FRESENIUS KABI USA
AP
LUITPOLD
AP
SAGENT PHARMS
AP
SUN PHARMA GLOBAL
SOLUTION;ORAL

CAFCIT

AA
+ EUROHLTH INTL SARL
CAFFEINE CITRATE

AA
EXELA PHARMA SCS LLC
AA
FRESENIUS KABI USA
AA
LUITPOLD
AA
SAGENT PHARMS
AA
SUN PHARMA GLOBAL

30MG
30MG
30MG
30MG
30MG
30MG

BASE/3ML
BASE/3ML
BASE/3ML
BASE/3ML
BASE/3ML
BASE/3ML

10MG
10MG
10MG
10MG
10MG
10MG

BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)

001
001
001
001
001
001

Apr
Mar
Jul
Mar
Dec
Dec

Sep
Sep
Jul
May
Aug
Sep

21,
08,
03,
07,
02,
29,

22,
21,
20,
15,
29,
30,

2008

2013

2007

2007

2013

2005

2015

2006

2007

2007

2012

2009

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N020793 002 Apr 12, 2000

EQ
EQ
EQ
EQ
EQ

A077304
A078002
A090064
A091102
A090357

30MG
30MG
30MG
30MG
30MG

BASE/3ML
BASE/3ML
BASE/3ML
BASE/3ML
BASE/3ML

CAFFEINE; ERGOTAMINE TARTRATE

SUPPOSITORY;RECTAL

MIGERGOT

+ CREALTA PHARMS LLC
100MG;2MG
TABLET;ORAL

CAFERGOT

AA
+ SANDOZ
100MG;1MG
ERGOTAMINE TARTRATE AND CAFFEINE

AA
HIKMA INTL PHARMS
100MG;1MG
AA
MIKART
100MG;1MG
CALCIPOTRIENE

AEROSOL, FOAM;TOPICAL

SORILUX

+ STIEFEL LABS INC
CREAM;TOPICAL

CALCIPOTRIENE

AB
GLENMARK PHARMS LTD
AB
TOLMAR
DOVONEX

AB
+ LEO PHARMA AS
OINTMENT;TOPICAL

CALCIPOTRIENE

+ GLENMARK GENERICS

(EQ
(EQ
(EQ
(EQ
(EQ
(EQ

001
001
001
001
001
001

(EQ
(EQ
(EQ
(EQ
(EQ

10MG
10MG
10MG
10MG
10MG

BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)

001
001
001
001
001

Sep
Jan
Nov
Aug
Sep

21,
31,
20,
29,
30,

2006

2008

2009

2012

2009

A086557 001 Oct 04, 1983

A084294 001

A040510 001 Sep 17, 2004

A040590 001 Sep 16, 2005

0.005%

N022563 001 Oct 06, 2010

0.005%
0.005%

A205772 001 Jun 09, 2015

A200935 001 May 30, 2012

0.005%

N020554 001 Jul 22, 1996

0.005%

A090633 001 Mar 24, 2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-58(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CALCIPOTRIENE

SOLUTION;TOPICAL

CALCIPOTRIENE

AT
FOUGERA PHARMS
AT
G AND W LABS INC
AT
HI TECH PHARMA
AT
+ TOLMAR

0.005%
0.005%
0.005%
0.005%

A078305
A078468
A077579
A077029

001
001
001
001

200 IU/ML

N017808 002 Mar 29, 1991

May
Mar
Nov
Nov

06,
24,
19,
20,

2008

2011

2009

2009

CALCITONIN SALMON

INJECTABLE;INJECTION

MIACALCIN

+ MYLAN IRELAND LTD
SPRAY, METERED;NASAL

CALCITONIN-SALMON

AB
APOTEX INC
AB
PAR PHARM
MIACALCIN

AB
+ MYLAN IRELAND LTD

200 IU/SPRAY
200 IU/SPRAY

A076396 001 Nov 17, 2008

A076979 001 Jun 08, 2009

200 IU/SPRAY

N020313 002 Aug 17, 1995

CALCITONIN SALMON RECOMBINANT

SPRAY, METERED;NASAL

FORTICAL

+ UPSHER SMITH

200 IU/SPRAY

N021406 001 Aug 12, 2005

0.25MCG
0.5MCG
0.25MCG
0.25MCG
0.5MCG
0.25MCG
0.5MCG

A091174
A091174
A076917
A091356
A091356
A075765
A075765

0.25MCG
0.5MCG

N018044 001

N018044 002

0.001MG/ML
0.001MG/ML

A078066 001 Jan 29, 2008

A076206 001 Sep 17, 2003

3MCG/GM

N022087 001 Jan 23, 2009

1MCG/ML

A076242 001 Jul 18, 2003

1MCG/ML

N021068 001 Nov 20, 1998

CALCITRIOL

CAPSULE;ORAL

CALCITRIOL

AB
BANNER LIFE SCIENCES
AB
AB
ROXANE
AB
STRIDES PHARMA
AB
AB
TEVA
AB
ROCALTROL

AB
VALIDUS PHARMS
AB
+
INJECTABLE;INJECTION

CALCITRIOL

AP
AKORN
AP
ROCKWELL MEDCL
OINTMENT;TOPICAL

VECTICAL

+ GALDERMA LABS LP
SOLUTION;ORAL

CALCITRIOL

AA
ROXANE
ROCALTROL

AA
+ VALIDUS PHARMS
CALCIUM ACETATE

CAPSULE;ORAL

CALCIUM ACETATE

AB
AMNEAL PHARMS
AB
HERITAGE PHARMS INC
AB
INVAGEN PHARMS
AB
LUPIN LTD
AB
NOSTRUM LABS INC
AB
PADDOCK LLC
AB
ROXANE
PHOSLO GELCAPS

AB
+ FRESENIUS MEDCL
SOLUTION;ORAL

PHOSLYRA

+ FRESENIUS MEDCL
TABLET;ORAL

CALCIUM ACETATE

AB
HERITAGE PHARMS INC
AB
INVAGEN PHARMS
AB
PADDOCK LLC
ELIPHOS

AB
+ CYPRESS PHARM

EQ
EQ
EQ
EQ
EQ
EQ
EQ

169MG
169MG
169MG
169MG
169MG
169MG
169MG

CALCIUM
CALCIUM
CALCIUM
CALCIUM
CALCIUM
CALCIUM
CALCIUM

A201658
A202315
A203135
A202127
A203179
A091312
A077728

001
002
001
001
002
001
002

001
001
001
001
001
001
001

May
May
Mar
Dec
Dec
Oct
Oct

Oct
Jun
Feb
Jul
Oct
Jun
Feb

24,
24,
27,
12,
12,
12,
12,

06,
29,
07,
09,
26,
01,
26,

2013

2013

2006

2014

2014

2001

2001

2014

2015

2013

2015

2015

2012

2008

EQ 169MG CALCIUM

N021160 003 Apr 02, 2001

EQ 169MG CALCIUM/5ML

N022581 001 Apr 18, 2011

EQ 169MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM

A202885 001 Jan 22, 2015

A202420 001 Feb 05, 2013

A091561 001 Apr 13, 2011

EQ 169MG CALCIUM

A078502 001 Nov 25, 2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-59(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CALCIUM CHLORIDE
INJECTABLE;INJECTION
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
+ HOSPIRA
100MG/ML

N021117 001 Jan 28, 2000

CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM

BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

SOLUTION;IRRIGATION

BSS PLUS
AT
+ ALCON
0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M
N018469 001

L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M

L

ENDOSOL EXTRA
AT
+ AKORN
0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M
N020079 001 Nov 27, 1991

L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M

L

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM

BICARBONATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0

N021703 010 Oct

5GM/1000ML;0.157GM/1000ML;2.21GM/1000ML

;7.07GM/1000ML (5000ML)

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0

N021703 011 Oct

5GM/1000ML;0.314GM/1000ML;2.21GM/1000ML

;7.07GM/1000ML (5000ML)

PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;

N021703 013 Oct

3.05GM/1000ML;0.314GM/1000ML;2.21GM/100

0ML;7.07GM/1000ML (5000ML)

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;

N021703 006 Oct

3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;

6.46GM/1000ML (5000ML)

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.0

N021703 002 Oct

3GM/1000ML;0.157GM/1000ML;3.09GM/1000ML

;6.46GM/1000ML (5000ML)

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;

N021703 003 Oct

2.03GM/1000ML;0.157GM/1000ML;3.09GM/100

0ML;6.46GM/1000ML (5000ML)

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.4

N021703 015 Oct

4GM/1000ML;0.314GM/1000ML;3.09GM/1000ML

;6.46GM/1000ML (5000ML)

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;

N021703 004 Oct

3.05GM/1000ML;0.314GM/1000ML;3.09GM/100

0ML;6.46GM/1000ML (5000ML)

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44

N021703 014 Oct

GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46

GM/1000ML (5000ML)

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2

N021703 001 Oct

.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6

.46GM/1000ML (5000ML)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

SOLUTION;INTRAPERITONEAL

DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER

+ B BRAUN
510MG/100ML;30GM/100ML;200MG/100ML;9.2G

N018807
M/100ML;9.6GM/100ML

+
510MG/100ML;30GM/100ML;200MG/100ML;9.4G

N018807
M/100ML;11GM/100ML

DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER

+ B BRAUN
510MG/100ML;50GM/100ML;200MG/100ML;9.2G

N018807
M/100ML;9.6GM/100ML

+
510MG/100ML;50GM/100ML;200MG/100ML;9.4G

N018807
M/100ML;11GM/100ML

10, 2008

10, 2008

10, 2008

25, 2006

25, 2006

25, 2006

10, 2008

25, 2006

10, 2008

25, 2006

001 Aug 26, 1983

003 Aug 26, 1983

002 Aug 26, 1983

004 Aug 26, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-60(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION;INTRAPERITONEAL

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5

N018379
67MG/100ML;392MG/100ML

AT
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5

N018883
67MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5

N018883
38MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5

N020171
38MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5

N018379
67MG/100ML;392MG/100ML

AT
25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5

N018883
67MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5

N018883
38MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5

N020171
38MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5

N018379
67MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;

N018379
567MG/100ML;392MG/100ML

AT
25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;

N018883
567MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;

N018883
538MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;

N020171
538MG/100ML;448MG/100ML

DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5

N018379
38MG/100ML;448MG/100ML

DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5

N018379
38MG/100ML;448MG/100ML

DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5

N018379
38MG/100ML;448MG/100ML

DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

AT
FRESENIUS MEDCL
25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;

N018379
538MG/100ML;448MG/100ML

DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5

N017512
67MG/100ML;392MG/100ML

DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5

N017512
67MG/100ML;392MG/100ML

DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;

N017512
567MG/100ML;392MG/100ML

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5

N020183
38MG/100ML;448MG/100ML

DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5

N017512
67MG/100ML;392MG/100ML

DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5

N017512
67MG/100ML;392MG/100ML

DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5

N017512
67MG/100ML;392MG/100ML

DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;

N017512
567MG/100ML;392MG/100ML

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5

N017512
38MG/100ML;448MG/100ML

AT
25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;

N020163

002

001 Nov 30, 1984

004 Nov 30, 1984

001 Aug 19, 1992

003

002 Nov 30, 1984

005 Nov 30, 1984

002 Aug 19, 1992

007 Jun 24, 1988

001

003 Nov 30, 1984

006 Nov 30, 1984

003 Aug 19, 1992

004 Jul 07, 1982

005 Jul 07, 1982

008 Jun 24, 1988

006 Jul 07, 1982

001

003

002

001 Dec 04, 1992

007 Jul 09, 1984

008 Jul 09, 1984

010 Nov 18, 1985

009 Jul 09, 1984

004

001 Dec 04, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-61(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION;INTRAPERITONEAL

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

538MG/100ML;448MG/100ML

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5

N017512
38MG/100ML;448MG/100ML

AT
25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5

N020163
38MG/100ML;448MG/100ML

DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5

N017512
38MG/100ML;448MG/100ML

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;

N017512
538MG/100ML;448MG/100ML

AT
25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;

N020163
538MG/100ML;448MG/100ML

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER

B BRAUN
26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/

N018460
100ML;450MG/100ML

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER

B BRAUN
26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/

N018460
100ML;450MG/100ML

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER

B BRAUN
26MG/100ML;4.25GM/100ML;5MG/100ML;530MG

N018460
/100ML;450MG/100ML

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;5

N020183
38MG/100ML;448MG/100ML

DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;5

N020183
38MG/100ML;448MG/100ML

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

BAXTER HLTHCARE
18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;

N020183
538MG/100ML;448MG/100ML

005

002 Dec 04, 1992

011 Nov 18, 1985

006

003 Dec 04, 1992

007 Jan 29, 1986

005 Nov 02, 1983

009 Jan 29, 1986

002 Dec 04, 1992

003 Dec 04, 1992

004 Dec 04, 1992

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM

CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

INJECTABLE;INTRATHECAL

ELLIOTTS B SOLUTION

+ LUKARE MEDICAL LLC
0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9

N020577 001 Sep 27, 1996

MG/ML;7.3MG/ML;0.2MG/ML

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER

AP
HOSPIRA
33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
00ML
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
AP
B BRAUN
33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
00ML

N018254 001

N020000 001 Apr 17, 1992

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP
HOSPIRA
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
N017608 001

00ML;310MG/100ML

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER

AP
B BRAUN
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
N019634 003 Feb
00ML;310MG/100ML

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
N016679 001

00ML;310MG/100ML

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
20MG/100ML;5GM/100ML;254MG/100ML;600MG/
N019367 006 Apr
100ML;310MG/100ML

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
20MG/100ML;5GM/100ML;179MG/100ML;600MG/
N019367 004 Apr
100ML;310MG/100ML

AP
20MG/100ML;5GM/100ML;328MG/100ML;600MG/
N019367 005 Apr
100ML;310MG/100ML

AP
HOSPIRA
20MG/100ML;5GM/100ML;179MG/100ML;600MG/
N019685 002 Oct
100ML;310MG/100ML

AP
20MG/100ML;5GM/100ML;328MG/100ML;600MG/
N019685 008 Oct
100ML;310MG/100ML

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
20MG/100ML;5GM/100ML;254MG/100ML;600MG/
N019367 007 Apr
100ML;310MG/100ML

24, 1988

05, 1985

05, 1985

05, 1985

17, 1988

17, 1988

05, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-62(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
20MG/100ML;5GM/100ML;328MG/100ML;600MG/
N019367 008 Apr
100ML;310MG/100ML

AP
HOSPIRA
20MG/100ML;5GM/100ML;328MG/100ML;600MG/
N019685 004 Oct
100ML;310MG/100ML

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER

B BRAUN
10MG/100ML;2.5GM/100ML;15MG/100ML;300MG
N019634 001
Feb
/100ML;160MG/100ML

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

BAXTER HLTHCARE
20MG/100ML;5GM/100ML;105MG/100ML;600MG/
N019367 002
Apr
100ML;310MG/100ML

20MG/100ML;5GM/100ML;179MG/100ML;600MG/
N019367 003
Apr
100ML;310MG/100ML

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

BAXTER HLTHCARE
20MG/100ML;5GM/100ML;105MG/100ML;600MG/
N019367 001
Apr
100ML;310MG/100ML

05, 1985

17, 1988

24, 1988

05, 1985

05, 1985

05, 1985

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

TPN ELECTROLYTES IN PLASTIC CONTAINER

+ HOSPIRA
16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;
N018895 001 Jul 20, 1984

16.1MG/ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;
CITRATE

SOLUTION;IRRIGATION

BALANCED SALT

AT
AKORN
0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6
.4MG/ML;1.7MG/ML

AT
B BRAUN
0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6
.4MG/ML;1.7MG/ML

BSS

AT
+ ALCON
0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6
.4MG/ML;1.7MG/ML

SODIUM CHLORIDE; SODIUM

A075503 001 Sep 27, 2006

A091387 001 Feb 03, 2010

N020742 001 Dec 10, 1997

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE;

SODIUM PHOSPHATE

INJECTABLE;INJECTION

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML

N207026 002 Jan 13, 2015

;2.21GM/1000ML;6.95GM/1000ML;0.187GM/10

00ML (5000ML)

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
3.68GM/1000ML;3.05GM/1000ML;0.314GM/100

N207026 001 Jan 13, 2015

0ML

;3.09GM/1000ML;6.34GM/1000ML;0.187GM/10

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

SOLUTION;PERFUSION, CARDIAC

CARDIOPLEGIC IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
17.6MG/100ML;325.3MG/100ML;119.3MG/100M

A075323 001 Apr 21, 2000

L;643MG/100ML

PLEGISOL IN PLASTIC CONTAINER

AT
+ HOSPIRA
17.6MG/100ML;325.3MG/100ML;119.3MG/100M

N018608 001 Feb 26, 1982

L;643MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

RINGER'S IN PLASTIC CONTAINER

AP
B BRAUN
33MG/100ML;30MG/100ML;860MG/100ML

AP
BAXTER HLTHCARE
33MG/100ML;30MG/100ML;860MG/100ML

AP
HOSPIRA
33MG/100ML;30MG/100ML;860MG/100ML

SOLUTION;IRRIGATION

RINGER'S IN PLASTIC CONTAINER

AT
B BRAUN
33MG/100ML;30MG/100ML;860MG/100ML

AT
BAXTER HLTHCARE
33MG/100ML;30MG/100ML;860MG/100ML

AT
HOSPIRA
33MG/100ML;30MG/100ML;860MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

LACTATED RINGER'S IN PLASTIC CONTAINER

AP
B BRAUN
20MG/100ML;30MG/100ML;600MG/100ML;310MG

/100ML

AP
BAXTER HLTHCARE
20MG/100ML;30MG/100ML;600MG/100ML;310MG

/100ML

AP
HOSPIRA
20MG/100ML;30MG/100ML;600MG/100ML;310MG

/100ML

N020002 001 Apr 17, 1992

N016693 001

N018251 001

N018156 001

N018495 001 Feb 19, 1982

N017635 001

N019632 001 Feb 29, 1988

N016682 001

N017641 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-63(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION;IRRIGATION

LACTATED RINGER'S IN PLASTIC CONTAINER

AT
+ B BRAUN
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML

AT
BAXTER HLTHCARE
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML

AT
+
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML

AT
+ HOSPIRA
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML

N018681 001 Dec 27, 1982

N018494 001 Feb 19, 1982

N018921 001 Apr 03, 1984

N019416 001 Jan 17, 1986

CALFACTANT

SUSPENSION;INTRATRACHEAL

INFASURF PRESERVATIVE FREE

+ ONY
35MG/ML

N020521 001 Jul 01, 1998

CANAGLIFLOZIN

TABLET;ORAL

INVOKANA

JANSSEN PHARMS
+

N204042 001 Mar 29, 2013

N204042 002 Mar 29, 2013

100MG
300MG

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

TABLET;ORAL

INVOKAMET

JANSSEN PHARMS
50MG;500MG
50MG;1GM
150MG;500MG
+
150MG;1GM
CANDESARTAN CILEXETIL

TABLET;ORAL

ATACAND

AB
ASTRAZENECA
AB
AB
AB
+
CANDESARTAN CILEXETIL

AB
APOTEX INC
AB
AB
AB
AB
SANDOZ
AB
AB
AB

N204353
N204353
N204353
N204353

001
002
003
004

Aug
Aug
Aug
Aug

08,
08,
08,
08,

2014

2014

2014

2014

4MG
8MG
16MG
32MG

N020838
N020838
N020838
N020838

001
002
003
004

Jun
Jun
Jun
Jun

04,
04,
04,
04,

1998

1998

1998

1998

4MG
8MG
16MG
32MG
4MG
8MG
16MG
32MG

A202079
A202079
A202079
A202079
A078702
A078702
A078702
A078702

001
002
003
004
001
002
003
004

Jan
Jan
Jan
Jan
May
May
May
May

10,
10,
10,
10,
03,
03,
03,
03,

2014

2014

2014

2014

2013

2013

2013

2013

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ATACAND HCT

AB
ASTRAZENECA
16MG;12.5MG
AB
32MG;12.5MG
AB
+
32MG;25MG
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

AB
APOTEX INC
16MG;12.5MG
AB
32MG;12.5MG
AB
32MG;25MG
AB
DR REDDYS LABS LTD
16MG;12.5MG
AB
32MG;12.5MG
AB
32MG;25MG
AB
MACLEODS PHARMS LTD
16MG;12.5MG
AB
32MG;12.5MG
AB
32MG;25MG
AB
MYLAN LABS
16MG;12.5MG
AB
32MG;12.5MG
AB
32MG;25MG

A202884
A202884
A202884
A202965
A202965
A202965
A204100
A204100
A204100
A090704
A090704
A090704

CANGRELOR

POWDER;IV (INFUSION)

KENGREAL

+ THE MEDICINES CO

N204958 001 Jun 22, 2015

50MG/VIAL

N021093 001 Sep 05, 2000

N021093 002 Sep 05, 2000

N021093 003 May 16, 2008

001
002
003
001
002
003
001
002
003
001
002
003

Dec
Dec
Jun
Jun
Jun
Jun
Feb
Feb
Feb
Dec
Dec
Dec

04,
04,
03,
03,
03,
03,
27,
27,
27,
04,
04,
04,

2012

2012

2013

2013

2013

2013

2015

2015

2015

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-64(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CAPECITABINE

TABLET;ORAL

CAPECITABINE

AB
ACCORD HLTHCARE
AB
AB
MYLAN PHARMS INC
AB
AB
TEVA PHARMS USA
AB
XELODA

AB
HOFFMANN LA ROCHE
AB
+

150MG
500MG
150MG
500MG
150MG
500MG

A202593
A202593
A090943
A090943
A091649
A091649

150MG
500MG

N020896 001 Apr 30, 1998

N020896 002 Apr 30, 1998

CAPREOMYCIN SULFATE

INJECTABLE;INJECTION

CAPASTAT SULFATE

+ AKORN

EQ 1GM BASE/VIAL

N050095 001

CAPSAICIN

PATCH;TOPICAL

QUTENZA

+ ACORDA

8%

N022395 001 Nov 16, 2009

CAPTOPRIL

TABLET;ORAL

CAPTOPRIL

AB
APOTEX
AB
AB
AB
AB
HIKMA PHARMS LLC
AB
AB
AB
AB
MYLAN
AB
AB
AB
+
AB
SANDOZ
AB
AB
AB
AB
STASON
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
WOCKHARDT
AB
AB
AB

12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG

A074737
A074737
A074737
A074737
A074505
A074505
A074505
A074505
A074434
A074434
A074434
A074434
A074363
A074363
A074363
A074363
A074677
A074677
A074677
A074677
A074322
A074322
A074322
A074322
A074386
A074386
A074386
A074386
A074532
A074532
A074532
A074532

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
004
002
001
003
001
002
003
004
001
002
003
004
001
002
003
004

Oct
Oct
Oct
Oct
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Nov
Nov
Nov
Nov
May
May
May
May
Feb
Feb
Feb
Feb
May
May
May
May
Mar
Mar
Mar
Mar

28,
28,
28,
28,
13,
13,
13,
13,
13,
13,
13,
13,
09,
09,
09,
09,
30,
30,
30,
30,
13,
13,
13,
13,
23,
23,
23,
23,
28,
28,
28,
28,

1998

1998

1998

1998

1996

1996

1996

1996

1996

1996

1996

1996

1995

1995

1995

1995

1997

1997

1997

1997

1996

1996

1996

1996

1996

1996

1996

1996

1997

1997

1997

1997

A074827
A074827
A074827
A074827
A074896
A074896
A074896
A074896

001
002
004
003
001
002
004
003

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

29,
29,
29,
29,
29,
29,
29,
29,

1997

1997

1997

1997

1997

1997

1997

1997

CAPTOPRIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

CAPTOPRIL AND HYDROCHLOROTHIAZIDE

AB
G AND W LABS INC
25MG;15MG
AB
25MG;25MG
AB
50MG;15MG
AB
50MG;25MG
AB
MYLAN
25MG;15MG
AB
+
25MG;25MG
AB
+
50MG;15MG
AB
50MG;25MG

001
002
001
002
001
002

Apr
Apr
Aug
Aug
Sep
Sep

23,
23,
08,
08,
16,
16,

2015

2015

2014

2014

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-65(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CARBACHOL

SOLUTION;INTRAOCULAR

MIOSTAT

+ ALCON

0.01%

CARBAMAZEPINE

CAPSULE, EXTENDED RELEASE;ORAL

CARBAMAZEPINE

AB
APOTEX INC

100MG

AB

200MG

AB

300MG

AB
MYLAN PHARMS INC

100MG

AB

200MG

AB

300MG

AB
TARO

100MG

AB

200MG

AB

300MG

AB
TEVA PHARMS

100MG

AB

200MG

AB

300MG

CARBATROL

AB
SHIRE

100MG

AB

200MG

AB
+

300MG

EQUETRO

VALIDUS PHARMS INC

100MG

200MG

+

300MG

SUSPENSION;ORAL

CARBAMAZEPINE

AB
WOCKHARDT

100MG/5ML

TEGRETOL

AB
+ NOVARTIS

100MG/5ML

TERIL

AB
TARO

100MG/5ML

TABLET;ORAL

CARBAMAZEPINE

AB
APOTEX INC

200MG

AB
TARO

200MG

AB
TORRENT PHARMS

200MG

EPITOL

AB
TEVA

200MG

TEGRETOL

AB
+ NOVARTIS

200MG

CARBAMAZEPINE

TORRENT PHARMS

100MG

300MG

400MG

TABLET, CHEWABLE;ORAL

CARBAMAZEPINE

AB
TARO PHARM INDS

100MG

AB
TORRENT PHARMS

100MG

EPITOL

AB
TEVA

100MG

TEGRETOL

AB
+ NOVARTIS

100MG

CARBAMAZEPINE

+ TARO PHARM INDS

200MG

TABLET, EXTENDED RELEASE;ORAL

CARBAMAZEPINE

AB
TARO

100MG

AB

200MG

AB

400MG

TEGRETOL-XR

AB
NOVARTIS

100MG

AB

200MG

AB
+

400MG

N016968 001

A078986
A078986
A078986
A076697
A076697
A076697
A201106
A201106
A201106
A078592
A078592
A078592

001
002
003
001
002
003
001
002
003
001
002
003

Nov
Nov
Nov
May
May
May
Jun
Jun
Jun
Sep
Sep
Sep

25,
25,
25,
20,
20,
20,
21,
21,
21,
20,
20,
20,

2011

2011

2011

2011

2011

2011

2013

2013

2013

2012

2012

2012

N020712 003 Sep 30, 1997

N020712 001 Sep 30, 1997

N020712 002 Sep 30, 1997

N021710 001 Dec 10, 2004

N021710 002 Dec 10, 2004

N021710 003 Dec 10, 2004

A075714 001 Jun 05, 2002

N018927 001 Dec 18, 1987

A076729 001 Sep 20, 2004

A075948 001 Feb 27, 2002

A074649 001 Oct 03, 1996

A077272 002 Dec 07, 2005

A070541 001 Sep 17, 1986

N016608 001

A077272 001 Dec 07, 2005

A077272 003 Dec 07, 2005

A077272 004 Dec 07, 2005

A075687 001 Oct 24, 2000

A075712 001 Jul 05, 2001

A073524 001 Jul 29, 1992

N018281 001

A075687 002 Jul 29, 2002

A078115 001 Mar 31, 2009

A078115 002 Mar 31, 2009

A078115 003 Mar 31, 2009

N020234 001 Mar 25, 1996

N020234 002 Mar 25, 1996

N020234 003 Mar 25, 1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-66(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CARBIDOPA

TABLET;ORAL

CARBIDOPA

AB
ALVOGEN MALTA
AB
AMERIGEN PHARMS LTD
LODOSYN

AB
+ ATON

25MG
25MG

A204291 001 Jan 08, 2016

A203261 001 Mar 10, 2014

25MG

N017830 001

CARBIDOPA; ENTACAPONE; LEVODOPA

TABLET;ORAL

CARBIDOPA, LEVODOPA AND ENTACAPONE

AB
SUN PHARMA GLOBAL
25MG;200MG;100MG
AB
37.5MG;200MG;150MG
AB
WOCKHARDT LTD
12.5MG;200MG;50MG
AB
18.75MG;200MG;75MG
AB
25MG;200MG;100MG
AB
31.25MG;200MG;125MG
AB
37.5MG;200MG;150MG
AB
50MG;200MG;200MG
STALEVO 100

AB
ORION PHARMA
25MG;200MG;100MG
STALEVO 125

AB
ORION PHARMA
31.25MG;200MG;125MG
STALEVO 150

AB
ORION PHARMA
37.5MG;200MG;150MG
STALEVO 200

AB
+ ORION PHARMA
50MG;200MG;200MG
STALEVO 50

AB
+ ORION PHARMA
12.5MG;200MG;50MG
STALEVO 75

AB
ORION PHARMA
18.75MG;200MG;75MG
CARBIDOPA; LEVODOPA

CAPSULE, EXTENDED RELEASE;ORAL

RYTARY

IMPAX LABS INC
23.75MG;95MG
36.25MG;145MG
48.75MG;195MG
+
61.25MG;245MG
SUSPENSION;ENTERAL

DUOPA

+ ABBVIE INC
4.63MG/ML;20MG/ML
TABLET;ORAL

CARBIDOPA AND LEVODOPA

AB
ACTAVIS ELIZABETH
10MG;100MG
AB
25MG;100MG
AB
25MG;250MG
AB
APOTEX INC
10MG;100MG
AB
25MG;100MG
AB
25MG;250MG
AB
MYLAN
10MG;100MG
AB
25MG;100MG
AB
25MG;250MG
AB
SUN PHARM INDS
10MG;100MG
AB
25MG;100MG
AB
25MG;250MG
AB
TEVA
10MG;100MG
AB
25MG;100MG
AB
25MG;250MG
SINEMET

AB
MERCK SHARP DOHME
10MG;100MG
AB
25MG;100MG
AB
+
25MG;250MG
TABLET, EXTENDED RELEASE;ORAL

CARBIDOPA AND LEVODOPA

AB
ACCORD HLTHCARE
25MG;100MG
AB
50MG;200MG
AB
APOTEX
25MG;100MG
AB
50MG;200MG
AB
IMPAX LABS
25MG;100MG
AB
50MG;200MG
AB
MYLAN
25MG;100MG
AB
50MG;200MG

A079085
A079085
A090786
A090833
A090833
A090833
A090833
A090833

001
002
001
001
002
003
004
005

May
May
Nov
Nov
Nov
Nov
Nov
Nov

10,
10,
20,
20,
20,
20,
20,
20,

2012

2012

2012

2012

2012

2012

2012

2012

N021485 002 Jun 11, 2003

N021485 006 Aug 29, 2008

N021485 003 Jun 11, 2003

N021485 004 Aug 02, 2007

N021485 001 Jun 11, 2003

N021485 005 Aug 29, 2008

N203312
N203312
N203312
N203312

001
002
003
004

Jan
Jan
Jan
Jan

07,
07,
07,
07,

2015

2015

2015

2015

N203952 001 Jan 09, 2015

A074260
A074260
A074260
A077120
A077120
A077120
A090324
A090324
A090324
A078536
A078536
A078536
A073618
A073589
A073607

001
002
003
001
002
003
001
002
003
001
002
003
001
001
001

Sep
Sep
Sep
Jun
Jun
Jun
Sep
Sep
Sep
Oct
Oct
Oct
Aug
Aug
Aug

03,
03,
03,
02,
02,
02,
28,
28,
28,
28,
28,
28,
28,
28,
28,

1993

1993

1993

2008

2008

2008

2009

2009

2009

2008

2008

2008

1992

1992

1992

Feb
Feb
Jun
Jun
May
May
Apr
Sep

08,
08,
16,
16,
14,
14,
21,
30,

2013

2013

2004

2004

2004

2004

2000

1999

N017555 001

N017555 003

N017555 002

A202323
A202323
A076212
A076212
A076521
A076521
A075091
A075091

001
002
001
002
001
002
002
001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-67(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CARBIDOPA; LEVODOPA

TABLET, EXTENDED RELEASE;ORAL

CARBIDOPA AND LEVODOPA

AB
SUN PHARM INDS
25MG;100MG
AB
50MG;200MG
SINEMET CR

AB
MERCK SHARP DOHME
25MG;100MG
AB
+
50MG;200MG
TABLET, ORALLY DISINTEGRATING;ORAL

CARBIDOPA AND LEVODOPA

AB
MYLAN
10MG;100MG
AB
25MG;100MG
AB
+
25MG;250MG
AB
SUN PHARMA GLOBAL
10MG;100MG
AB
25MG;100MG
AB
25MG;250MG

A077828 001 Aug 23, 2007

A077828 002 Aug 23, 2007

N019856 002 Dec 24, 1992

N019856 001 May 30, 1991

A078893
A078893
A078893
A078690
A078690
A078690

001
002
003
001
002
003

Sep
Sep
Sep
Jul
Jul
Jul

18,
18,
18,
31,
31,
31,

2008

2008

2008

2009

2009

2009

CARBINOXAMINE MALEATE

SOLUTION;ORAL

CARBINOXAMINE MALEATE

AA
CYPRESS PHARM
4MG/5ML
AA
+ MIKART
4MG/5ML
AA
VINTAGE PHARMS
4MG/5ML
SUSPENSION, EXTENDED RELEASE;ORAL

KARBINAL ER

+ TRIS PHARMA INC
4MG/5ML
TABLET;ORAL

CARBINOXAMINE MALEATE

AA
CYPRESS PHARM
4MG
AA
INVAGEN PHARMS
4MG
AA
+ MIKART
4MG
AA
MISSION PHARMACAL CO
4MG
AA
VINTAGE PHARMS
4MG

A090417
A090435
A040442
A090756
A040639

001
001
001
001
002

Aug
Apr
Mar
May
May

23,
15,
19,
27,
30,

2010

2010

2003

2011

2008

CARBOPLATIN

INJECTABLE;IV (INFUSION)

CARBOPLATIN

AP
ACTAVIS TOTOWA
AP
AP
AP
AP
AKORN
AP
AP
AP
AP
CIPLA LTD
AP
AP
AP
AP
EBEWE PHARMA
AP
AP
AP
EUROHLTH INTL SARL
AP
AP
AP
AP
FRESENIUS KABI ONCOL
AP
AP
AP
FRESENIUS KABI USA
AP
AP
AP
HOSPIRA
AP
AP
AP
AP
MYLAN INSTITUTIONAL
AP
AP
AP
MYLAN LABS LTD
AP
AP
AP

A078732
A078732
A078732
A078732
A090475
A090475
A090475
A091268
A077861
A077861
A077861
A077861
A078280
A078280
A078280
A077244
A077244
A077244
A077244
A077432
A077432
A077432
A077247
A077266
A077266
A076517
A076517
A076517
A077059
A077998
A077998
A077998
A091063
A091063
A091063
A091063

001
002
003
004
001
002
003
002
001
002
003
004
001
002
003
001
002
003
004
001
002
003
003
003
004
001
002
003
001
001
002
003
001
002
003
004

Feb
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Jan
Jan
Jan
Jan
May
May
May
Oct
Oct
Oct
Jan
Sep
Sep
Sep
Oct
Feb
Feb
Oct
Oct
Oct
Nov
Apr
Apr
Apr
Nov
Nov
Nov
Nov

06,
06,
06,
06,
29,
29,
29,
28,
18,
18,
18,
18,
08,
08,
08,
15,
15,
15,
20,
29,
29,
29,
21,
15,
15,
14,
14,
14,
23,
24,
24,
24,
09,
09,
09,
09,

2012

2012

2012

2012

2009

2009

2009

2010

2007

2007

2007

2007

2008

2008

2008

2004

2004

2004

2006

2006

2006

2006

2004

2006

2006

2004

2004

2004

2004

2007

2007

2007

2011

2011

2011

2011

50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
450MG/45ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)

A090418 001 May 04, 2010

A040458 001 Apr 25, 2003

A040814 001 Feb 26, 2008

N022556 001 Mar 28, 2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-68(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CARBOPLATIN

INJECTABLE;IV (INFUSION)

CARBOPLATIN

AP
+ PHARMACHEMIE BV
AP
+
AP
+
AP
+
AP
PLIVA LACHEMA
AP
AP
AP
AP
SAGENT PHARMS
AP
AP
AP
AP
SUN PHARMA GLOBAL
AP
AP
AP
+ TEVA PHARMS USA
AP
+
AP
+
AP
+
+ MYLAN LABS LTD

50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
1GM/100ML (10MG/ML)

A077269
A077269
A077269
A077269
A078631
A078631
A078631
A078631
A077096
A077096
A077096
A077096
A077926
A077926
A077926
A077139
A077139
A077139
A077139
A091478

CARBOPROST TROMETHAMINE

INJECTABLE;INJECTION

HEMABATE

+ PHARMACIA AND UPJOHN

EQ 0.25MG BASE/ML

N017989 001

CARFILZOMIB

POWDER;INTRAVENOUS

KYPROLIS

+ ONYX PHARMS

60MG/VIAL

N202714 001 Jul 20, 2012

CARGLUMIC ACID

TABLET;ORAL

CARBAGLU

+ ORPHAN EUROPE

200MG

N022562 001 Mar 18, 2010

EQ
EQ
EQ
EQ

N204370
N204370
N204370
N204370

001
002
003
004

Sep
Sep
Sep
Sep

17,
17,
17,
17,

2015

2015

2015

2015

350MG
350MG
350MG
350MG
350MG
350MG
350MG
350MG
350MG
350MG
350MG
350MG

A040576
A040792
A205126
A040823
A090988
A205085
A203374
A205513
A089346
A040755
A040245
A087499

001
001
002
001
001
001
001
002
001
001
001
001

Jun
Aug
Jul
Oct
Oct
Oct
Jan
Nov
Oct
Feb
Sep
Apr

07,
06,
08,
22,
28,
28,
27,
12,
17,
27,
08,
20,

2005

2009

2015

2008

2014

2014

2014

2015

1991

2007

1997

1982

350MG

N011792 001

250MG
250MG

A205126 001 Jul 08, 2015

A205513 001 Nov 12, 2015

250MG

N011792 004 Sep 13, 2007

CARIPRAZINE HYDROCHLORIDE

CAPSULE;ORAL

VRAYLAR

FOREST RES INST INC

+
CARISOPRODOL

TABLET;ORAL

CARISOPRODOL

AA
ACCELRX LABS
AA
AUROBINDO PHARMA
AA
INDICUS PHARMA
AA
MIRROR PHARMS
AA
NATCO PHARMA LTD
AA
ORIENT PHARMA CO LTD
AA
SCIEGEN PHARMS INC
AA
SHASUN PHARMS LTD
AA
SUN PHARM INDS
AA
SUN PHARM INDS LTD
AA
VINTAGE PHARMS
AA
WATSON LABS
SOMA

AA
MEDA PHARMS
CARISOPRODOL

AB
INDICUS PHARMA
AB
SHASUN PHARMS LTD
SOMA

AB
+ MEDA PHARMS

1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004
001

Oct
Oct
Oct
Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Nov

14,
14,
14,
28,
02,
02,
02,
02,
14,
14,
14,
03,
19,
19,
19,
21,
21,
21,
21,
23,

2004

2004

2004

2007

2008

2008

2008

2008

2005

2005

2005

2013

2008

2008

2008

2005

2005

2005

2005

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-69(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CARMUSTINE

IMPLANT;INTRACRANIAL

GLIADEL

+ ARBOR PHARMS LLC

INJECTABLE;INJECTION

BICNU

+ EMCURE PHARMS LTD

CARTEOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CARTEOLOL HYDROCHLORIDE

AT
ALCON
AT
BAUSCH AND LOMB
OCUPRESS
AT
+ NOVARTIS
CARVEDILOL

TABLET;ORAL

CARVEDILOL

AB
APOTEX INC

AB

AB

AB

AB
AUROBINDO PHARMA

AB

AB

AB

AB
BEXIMCO USA

AB

AB

AB

AB
CIPLA LTD

AB

AB

AB

AB
DR REDDYS LABS LTD

AB

AB

AB

AB
GLENMARK GENERICS

AB

AB

AB

AB
LUPIN

AB

AB

AB

AB
MYLAN

AB

AB

AB

AB
PLIVA HRVATSKA DOO

AB

AB

AB

AB
SANDOZ

AB

AB

AB

AB
SUN PHARM INDS INC

AB

AB

AB

AB
SUN PHARM INDS LTD

AB

AB

AB

AB
TARO

AB

AB

AB

AB
TEVA

AB

7.7MG

N020637 001 Sep 23, 1996

100MG/VIAL

N017422 001

1%

1%

A075476 001 Jan 03, 2000

A075546 001 Jan 20, 2000

1%

N019972 001 May 23, 1990

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

12.5MG

25MG

3.125MG

6.25MG

A078165
A078165
A078165
A078165
A078332
A078332
A078332
A078332
A078384
A078384
A078384
A078384
A077474
A077474
A077474
A077474
A076649
A076649
A076649
A076649
A078251
A078251
A078251
A078251
A078217
A078217
A078217
A078217
A077316
A077316
A077316
A077316
A078240
A078240
A078240
A078240
A078227
A078227
A078227
A078227
A077346
A077346
A077346
A077346
A076989
A076989
A076989
A076989
A077780
A077780
A077780
A077780
A076373
A076373

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
004
001
002
003
001
002
003
004
001
002
003
004
001
002

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
30,
30,
30,
30,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-70(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CARVEDILOL

TABLET;ORAL

CARVEDILOL

AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
AB
COREG

AB
SMITHKLINE BEECHAM
AB
AB
+
AB

12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG

A076373
A076373
A077614
A077614
A077614
A077614

003
004
004
001
002
003

Sep
Sep
Sep
Sep
Sep
Sep

05,
05,
05,
05,
05,
05,

2007

2007

2007

2007

2007

2007

3.125MG
6.25MG
12.5MG
25MG

N020297
N020297
N020297
N020297

004
003
002
001

May
Sep
Sep
Sep

29,
14,
14,
14,

1997

1995

1995

1995

CARVEDILOL PHOSPHATE

CAPSULE, EXTENDED RELEASE;ORAL

COREG CR

SB PHARMCO
10MG
20MG
+
40MG
80MG

N022012
N022012
N022012
N022012

001
002
003
004

Oct
Oct
Oct
Oct

20,
20,
20,
20,

2006

2006

2006

2006

CASPOFUNGIN ACETATE

INJECTABLE;IV (INFUSION)

CANCIDAS

+ MERCK
+

N021227 001 Jan 26, 2001

N021227 002 Jan 26, 2001

50MG/VIAL
70MG/VIAL

CEFACLOR

CAPSULE;ORAL

CEFACLOR

AB
HIKMA
EQ
AB
+
EQ
AB
YUNG SHIN PHARM
EQ
AB
EQ
FOR SUSPENSION;ORAL

CEFACLOR

AB
YUNG SHIN PHARM
EQ
AB
EQ
AB
EQ
AB
+
EQ
TABLET, EXTENDED RELEASE;ORAL

CEFACLOR

TEVA
EQ
+
EQ
CEFADROXIL/CEFADROXIL HEMIHYDRATE

CAPSULE;ORAL

CEFADROXIL

AB
AUROBINDO PHARMA
EQ
AB
HIKMA
EQ
AB
LUPIN
EQ
AB
ORCHID HLTHCARE
EQ
AB
SANDOZ
EQ
AB
+ TEVA PHARMS
EQ
FOR SUSPENSION;ORAL

CEFADROXIL

AB
AUROBINDO
EQ
AB
EQ
AB
HIKMA PHARMS
EQ
AB
EQ
AB
LUPIN
EQ
AB
+
EQ
AB
ORCHID HLTHCARE
EQ
AB
EQ
AB
SUN PHARM INDS LTD
EQ
AB
EQ
EQ
TABLET;ORAL

CEFADROXIL

AB
HIKMA
EQ
AB
ORCHID HLTHCARE
EQ
+ TEVA PHARMS
EQ

250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE

A065350
A065350
A065146
A065146

001
002
001
002

Apr
Apr
Jan
Jan

03,
03,
22,
22,

2007

2007

2004

2004

125MG
187MG
250MG
375MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A065412
A065412
A065412
A065412

001
002
003
004

Feb
Feb
Feb
Feb

17,
17,
17,
17,

2012

2012

2012

2012

375MG BASE
500MG BASE

A065058 001 Sep 04, 2002

A065058 002 Sep 04, 2002

500MG
500MG
500MG
500MG
500MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE

A065352
A065311
A065392
A065309
A062291
A065282

001
001
001
001
001

001

Jan
Feb
May
Sep

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
125MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A065349
A065349
A091036
A091036
A065396
A065396
A065307
A065307
A065115
A065115
A065115

001
002
001
002
001
002
002
003
002
003
001

Apr
Apr
Nov
Nov
Feb
Feb
Oct
Oct
Mar
Mar
Mar

1GM BASE
1GM BASE
1GM BASE

25,
07,
29,
18,

2007

2006

2007

2006

Jan 20, 2006

25,
25,
28,
28,
21,
21,
16,
16,
26,
26,
26,

2013

2013

2012

2012

2008

2008

2006

2006

2003

2003

2003

A065260 001 Mar 30, 2006

A065301 001 Sep 18, 2006

A062774 001 Apr 08, 1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-71(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CEFAZOLIN SODIUM

INJECTABLE;INJECTION

CEFAZOLIN SODIUM

AP
ACS DOBFAR
AP
AP
AP
AP
FACTA FARMA
AP
AP
AP
+
AP
HIKMA FARMACEUTICA
AP
AP
AP
+ HOSPIRA INC
AP
+
AP
+
AP
+
AP
QILU PHARM CO LTD
AP
SANDOZ
AP
AP
AP
KEFZOL

AP
ACS DOBFAR
AP
AP
ANCEF IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
+
CEFAZOLIN AND DEXTROSE

+ B BRAUN

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
20GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
20GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
1GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL

001
002
001
002
001
001
001
002
001
002
001
001
002
001
001
001
001
002
001
003

Oct
Oct
Oct
Aug
Dec
Dec
Dec
Apr
Sep
Sep
Oct
Apr
Apr
Aug
Aug
Dec
Dec
Dec
May
Sep

22,
22,
22,
18,
27,
27,
27,
30,
18,
18,
18,
21,
21,
12,
12,
28,
09,
09,
09,
25,

2008

2008

2008

2014

1991

1991

1991

1999

2001

2001

2004

2005

2005

2005

2005

2015

1988

1988

2007

1992

EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL

A061773 002

A061773 003

A061773 004

EQ 10MG BASE/ML
EQ 20MG BASE/ML

A063002 001 Mar 28, 1991

A063002 002 Mar 28, 1991

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL

N050779 002 Jul 27, 2000

N050779 003 Jan 13, 2012

CEFAZOLIN SODIUM

+ SAMSON MEDCL
EQ 100GM BASE/VIAL
+
EQ 300GM BASE/VIAL
SOLUTION;INTRAVENOUS

CEFAZOLIN IN PLASTIC CONTAINER

BAXTER HLTHCARE
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
CEFDINIR

CAPSULE;ORAL

CEFDINIR

AB
AUROBINDO PHARMA
AB
LUPIN
AB
ORCHID HLTHCARE
AB
+ SANDOZ
AB
TEVA PHARMS
FOR SUSPENSION;ORAL

CEFDINIR

AB
AUROBINDO PHARMA
AB
AB
LUPIN
AB
AB
ORCHID HLTHCARE
AB
AB
SANDOZ
AB
+
AB
TEVA PHARMS
AB

A065303
A065303
A065306
A065306
A063214
A063207
A063209
A063209
A065047
A065047
A065143
A065226
A065226
A065244
A065247
A203661
A062831
A062831
A065345
A062831

A065141 001 Nov 29, 2006

A065141 002 Nov 29, 2006

N207131 001 Aug 07, 2015

300MG
300MG
300MG
300MG
300MG

A065434
A065264
A065418
A065330
A065368

001
001
001
001
001

Jan
May
Jul
Apr
May

07,
19,
18,
06,
09,

2008

2006

2007

2007

2007

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML

A065473
A065473
A065259
A065259
A065429
A065429
A065337
A065337
A065332
A065332

001
002
001
002
001
002
001
002
001
002

Dec
Dec
May
May
Jul
Jul
Apr
Apr
May
May

14,
14,
31,
07,
18,
18,
06,
06,
04,
04,

2007

2007

2006

2007

2007

2007

2007

2007

2007

2007

CEFDITOREN PIVOXIL

TABLET;ORAL

SPECTRACEF

VANSEN PHARMA
+

200MG
400MG

N021222 001 Aug 29, 2001

N021222 002 Jul 21, 2008

CEFEPIME HYDROCHLORIDE

INJECTABLE;INJECTION

CEFEPIME HYDROCHLORIDE

AP
ACS DOBFAR
AP
AP
HOSPIRA INC
AP

EQ
EQ
EQ
EQ

A065441
A065441
A065369
A065369

1GM BASE/VIAL
2GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL

001
002
001
002

Mar
Mar
Jun
Jun

20,
20,
18,
18,

2008

2008

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-72(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CEFEPIME HYDROCHLORIDE

INJECTABLE;INJECTION

CEFEPIME HYDROCHLORIDE

AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
MAXIPIME

AP
+ HOSPIRA INC
EQ 500MG BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER

B BRAUN
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
CEFEPIME IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
+
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
CEFIXIME

CAPSULE;ORAL

SUPRAX

+ LUPIN LTD
FOR SUSPENSION;ORAL

CEFIXIME

AB
AUROBINDO PHARMA LTD
AB
SUPRAX

AB
LUPIN PHARMS
AB
+ LUPIN LTD
TABLET;ORAL

SUPRAX

+ LUPIN PHARMS
TABLET, CHEWABLE;ORAL

SUPRAX

LUPIN LTD
+

A202268 001 Jul 30, 2012

A065369 003 Jun 18, 2007

A202268 002 Jul 30, 2012

N050679 001 Jan 18, 1996

N050679 002 Jan 18, 1996

N050679 003 Jan 18, 1996

N050821 001 May 06, 2010

N050821 002 May 06, 2010

N050817 001 Aug 05, 2008

N050817 002 Aug 05, 2008

400MG

N203195 001 Jun 01, 2012

100MG/5ML
200MG/5ML

A204835 001 Apr 14, 2015

A204835 002 Apr 14, 2015

100MG/5ML
200MG/5ML
500MG/5ML

A065129 001 Feb 23, 2004

A065355 001 Apr 10, 2007

N202091 001 Feb 20, 2013

400MG

A065130 001 Feb 12, 2004

100MG
150MG
200MG

A065380 001 Oct 25, 2010

A065380 002 Oct 25, 2010

A065380 003 Oct 25, 2010

CEFOTAXIME SODIUM

INJECTABLE;INJECTION

CEFOTAXIME

AP
HIKMA
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
WOCKHARDT
EQ 1GM BASE/VIAL
CEFOTAXIME SODIUM

AP
HOSPIRA INC
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
LUPIN
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
WOCKHARDT
EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL
CLAFORAN

AP
+ SANOFI AVENTIS US
EQ 500MG BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
AP
+
EQ 10GM BASE/VIAL
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER

+ SANOFI AVENTIS US
EQ 20MG BASE/ML
+
EQ 40MG BASE/ML

A065072
A065072
A065072
A065071
A065197

001
002
003
001
001

Nov
Nov
Nov
Nov
Aug

20,
20,
20,
20,
29,

2002

2002

2002

2002

2006

A065290
A065290
A065293
A065290
A065293
A065292
A065124
A065124
A065124
A065197
A065197

001
002
001
003
002
001
001
002
003
002
003

Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Jun
Jun

11,
11,
10,
11,
10,
10,
24,
24,
24,
20,
20,

2006

2006

2006

2006

2006

2006

2003

2003

2003

2008

2008

N050547
A062659
N050547
A062659
N050547
N050547

001

001 Jan 13, 1987

002

002 Jan 13, 1987

003

004 Dec 29, 1983

N050596 002 May 20, 1985

N050596 004 May 20, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-73(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CEFOTETAN DISODIUM

INJECTABLE;INJECTION

CEFOTETAN

AP
+ FRESENIUS KABI USA
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
AP
+
EQ 10GM BASE/VIAL
AP
WEST-WARD PHARM CORP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER

+ B BRAUN
EQ 1GM BASE/VIAL
+
EQ 2GM BASE/VIAL
CEFOXITIN SODIUM

INJECTABLE;INJECTION

CEFOXITIN

AP
+ ACS DOBFAR
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
AP
+
EQ 10GM BASE/VIAL
AP
ANTIBIOTICOS BRASIL
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
HIKMA FARMACEUTICA
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
HIKMA MAPLE
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
HOSPIRA INC
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER

AP
B BRAUN
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
MEFOXIN IN PLASTIC CONTAINER

+ MYLAN INSTITUTIONAL
EQ 20MG BASE/ML
+
EQ 40MG BASE/ML
POWDER;IV (INFUSION)

CEFOXITIN IN PLASTIC CONTAINER

SAMSON MEDCL
EQ 100GM BASE
CEFPODOXIME PROXETIL

FOR SUSPENSION;ORAL

CEFPODOXIME PROXETIL

AB
AUROBINDO PHARMA LTD
AB
AB
SANDOZ
AB
+
AB
SUN PHARM INDS LTD
AB
TABLET;ORAL

CEFPODOXIME PROXETIL

AB
AUROBINDO PHARMA
AB
AB
ORCHID HLTHCARE
AB
AB
SANDOZ
AB
+
AB
SUN PHARM INDS LTD
AB
CEFPROZIL

FOR SUSPENSION;ORAL

CEFPROZIL

AB
APOTEX INC
AB
AB
AUROBINDO PHARMA
AB
AB
LUPIN
AB
+
AB
ORCHID HLTHCARE
AB
AB
SANDOZ
AB

A065374
A065374
A065375
A091031
A091031
A091030

001
002
001
001
002
001

Aug
Aug
Aug
Oct
Oct
Oct

09,
09,
09,
26,
26,
26,

2007

2007

2007

2011

2011

2011

A065430 001 Aug 09, 2007

A065430 002 Aug 09, 2007

A065414
A065414
A065415
A065467
A065467
A065464
A065238
A065238
A065239
A065051
A065051
A065050
A065313
A065313
A065312

001
002
001
001
002
001
001
002
001
001
002
001
001
002
001

Jun
Jun
May
Aug
Aug
Aug
Mar
Mar
Mar
Sep
Sep
Sep
Jan
Jan
Feb

12,
12,
19,
31,
31,
31,
12,
12,
02,
11,
11,
11,
23,
23,
13,

2009

2009

2010

2011

2011

2011

2010

2010

2010

2000

2000

2000

2006

2006

2006

A065214 001 Mar 10, 2006

A065214 002 Mar 10, 2006

A063182 001 Jan 25, 1993

A063182 002 Jan 25, 1993

A200938 001 Nov 16, 2015

EQ
EQ
EQ
EQ
EQ
EQ

50MG BASE/5ML
100MG BASE/5ML
50MG BASE/5ML
100MG BASE/5ML
50MG BASE/5ML
100MG BASE/5ML

A065409
A065409
A090031
A090031
A065082
A065082

001
002
001
002
001
002

Jun
Jun
Jan
Jan
May
May

08,
08,
14,
14,
31,
31,

2007

2007

2009

2009

2002

2002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG

A065370
A065370
A065388
A065388
A065462
A065462
A065083
A065083

001
002
001
002
001
002
001
002

Jun
Jun
Nov
Nov
May
May
Aug
Aug

11,
11,
14,
14,
28,
28,
20,
20,

2007

2007

2007

2007

2008

2008

2003

2003

A065351
A065351
A065381
A065381
A065261
A065261
A065284
A065284
A065257
A065257

001
002
001
002
001
002
002
001
001
002

Feb
Feb
Jan
Jan
Dec
Dec
Dec
Dec
Dec
Dec

29,
29,
30,
30,
19,
19,
30,
30,
08,
08,

2012

2012

2007

2007

2005

2005

2005

2005

2005

2005

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-74(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CEFPROZIL

FOR SUSPENSION;ORAL

CEFPROZIL

AB
TEVA PHARMS
AB
TABLET;ORAL

CEFPROZIL

AB
APOTEX INC
AB
AB
AUROBINDO PHARMA LTD
AB
AB
LUPIN
AB
+
AB
ORCHID HLTHCARE
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB
WOCKHARDT
AB
CEFTAROLINE FOSAMIL

POWDER;IV (INFUSION)

TEFLARO

CEREXA
+

125MG/5ML
250MG/5ML

A065236 001 Dec 08, 2005

A065236 002 Dec 08, 2005

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A065327
A065327
A065340
A065340
A065276
A065276
A065267
A065267
A065235
A065235
A065208
A065208
A065428
A065428

400MG/VIAL
600MG/VIAL

N200327 001 Oct 29, 2010

N200327 002 Oct 29, 2010

001
002
001
002
001
002
001
002
001
002
001
002
001
002

Mar
Mar
May
May
Dec
Dec
Dec
Dec
Nov
Nov
Dec
Dec
Jun
Jun

26,
26,
24,
24,
08,
08,
19,
19,
14,
14,
06,
06,
14,
14,

2008

2008

2007

2007

2005

2005

2005

2005

2005

2005

2005

2005

2007

2007

CEFTAZIDIME

INJECTABLE;INJECTION

CEFTAZIDIME

AP
ACS DOBFAR
500MG/VIAL
AP
1GM/VIAL
AP
2GM/VIAL
AP
6GM/VIAL
AP
WOCKHARDT
1GM/VIAL
FORTAZ

AP
+ IGI LABS INC
500MG/VIAL
AP
+
1GM/VIAL
AP
+
2GM/VIAL
AP
+
6GM/VIAL
TAZICEF

AP
HOSPIRA
500MG/VIAL
AP
1GM/VIAL
AP
1GM/VIAL
AP
2GM/VIAL
AP
2GM/VIAL
AP
6GM/VIAL
CEFTAZIDIME IN DEXTROSE CONTAINER

B BRAUN
EQ 1GM BASE
+
EQ 2GM BASE

N050823 001 Jun 13, 2011

N050823 002 Jun 13, 2011

CEFTAZIDIME SODIUM

INJECTABLE;INJECTION

FORTAZ IN PLASTIC CONTAINER

+ IGI LABS INC
EQ 20MG BASE/ML
+
EQ 40MG BASE/ML

N050634 002 Apr 28, 1989

N050634 003 Apr 28, 1989

CEFTIBUTEN DIHYDRATE

CAPSULE;ORAL

CEDAX

+ PERNIX THERAP
FOR SUSPENSION;ORAL

CEDAX

+ PERNIX THERAP
+

A062640
A062640
A062640
A062640
A065196

001
002
003
004
001

Nov
Nov
Nov
Feb
Oct

20,
20,
20,
03,
15,

1985

1985

1985

1992

2008

N050578
N050578
N050578
N050578

001
002
003
004

Jul
Jul
Jul
Jul

19,
19,
19,
19,

1985

1985

1985

1985

A062662
A062662
A064032
A062662
A064032
A062662

001
002
001
003
002
004

Mar
Mar
Oct
Mar
Oct
Mar

06,
06,
31,
06,
31,
06,

1986

1986

1993

1986

1993

1986

EQ 400MG BASE

N050685 002 Dec 20, 1995

EQ 90MG BASE/5ML
EQ 180MG BASE/5ML

N050686 001 Dec 20, 1995

N050686 002 Dec 20, 1995

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

POWDER;IV (INFUSION)

ZERBAXA

+ CUBIST PHARMS LLC
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL

N206829 001 Dec 19, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-75(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CEFTRIAXONE SODIUM

INJECTABLE;INJECTION

CEFTRIAXONE

AP
ACS DOBFAR
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
BEDFORD
EQ 10GM BASE/VIAL
AP
FACTA FARMA
EQ 10GM BASE/VIAL
AP
HOSPIRA INC
EQ 1GM BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
LUPIN
EQ 10GM BASE/VIAL
AP
+ SANDOZ
EQ 10GM BASE/VIAL
AP
+ SANDOZ INC
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
AP
WOCKHARDT
EQ 1GM BASE/VIAL
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER

AP
+ B BRAUN
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
ROCEPHIN

AP
+ HOFFMANN LA ROCHE
EQ 500MG BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
CEFTRIAXONE

SAMSON MEDCL
EQ 100GM BASE/VIAL
CEFTRIAXONE IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
EQ 20MG BASE/ML
+
EQ 40MG BASE/ML
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

CEFTRIAXONE

AP
AKORN INC
EQ 250MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
BEDFORD
EQ 250MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
HIKMA FARMACEUTICA
EQ 250MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
HOSPIRA INC
EQ 250MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
LUPIN
EQ 250MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
+ SANDOZ
EQ 250MG BASE/VIAL
AP
+
EQ 500MG BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
AP
WOCKHARDT
EQ 250MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL
CEFUROXIME AXETIL

FOR SUSPENSION;ORAL

CEFTIN

AB
GLAXOSMITHKLINE
AB
+
CEFUROXIME AXETIL

AB
SUN PHARM INDS LTD
AB
TABLET;ORAL

CEFTIN

AB
GLAXOSMITHKLINE
AB
AB
+

A065329
A065329
A065329
A065328
A065475
A065269
A065231
A202563
A065231
A202563
A065232
A065263
A065168
A065204
A065204
A065180

001
002
003
001
001
001
001
001
002
002
001
001
001
001
002
001

Jul
Jul
Jul
Jul
Aug
Feb
Aug
Aug
Aug
Aug
Aug
Sep
May
May
May
May

24,
24,
24,
24,
18,
28,
02,
20,
02,
20,
02,
12,
17,
03,
03,
12,

2008

2008

2008

2008

2008

2007

2005

2012

2005

2012

2005

2006

2005

2005

2005

2006

N050796 001 Apr 20, 2005

N050796 002 Apr 20, 2005

A063239 002 Aug 13, 1993

A063239 003 Aug 13, 1993

A090057 001 Apr 25, 2014

A065224 001 Aug 23, 2005

A065224 002 Aug 23, 2005

A065305
A065305
A065305
A065305
A065465
A065465
A065465
A065465
A065342
A065342
A065342
A065342
A065230
A065230
A065230
A065230
A065125
A065125
A065125
A065125
A065169
A065169
A065169
A065169
A065391
A065391
A065391

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003

Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
May
May
May
May
Apr
Apr
Apr

11,
11,
11,
11,
18,
18,
18,
18,
10,
10,
10,
10,
02,
02,
02,
02,
30,
30,
30,
30,
09,
09,
09,
09,
12,
12,
12,

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2005

2005

2005

2005

2003

2003

2003

2003

2005

2005

2005

2005

2007

2007

2007

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

N050672 001 Jun 30, 1994

N050672 002 Apr 29, 1997

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

A065323 001 Feb 05, 2008

A065323 002 Feb 05, 2008

EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE

N050605 001 Dec 28, 1987

N050605 002 Dec 28, 1987

N050605 003 Dec 28, 1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-76(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CEFUROXIME AXETIL

TABLET;ORAL

CEFUROXIME AXETIL

AB
ALKEM LABS LTD
AB
AB
ANI PHARMS INC
AB
AB
APOTEX
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
LUPIN
AB
AB
ORCHID HLTHCARE
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
WOCKHARDT
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG
250MG
500MG
125MG
250MG
500MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

CEFUROXIME SODIUM

INJECTABLE;INJECTION

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER

AP
+ B BRAUN
EQ 750MG BASE/VIAL
AP
+
EQ 1.5GM BASE/VIAL
CEFUROXIME SODIUM

AP
FACTA FARMA
EQ 1.5GM BASE/VIAL
AP
EQ 7.5GM BASE/VIAL
AP
HIKMA FARMACEUTICA
EQ 1.5GM BASE/VIAL
AP
EQ 7.5GM BASE/VIAL
AP
HOSPIRA INC
EQ 1.5GM BASE/VIAL
AP
EQ 1.5GM BASE/VIAL
AP
EQ 7.5GM BASE/VIAL
ZINACEF

AP
+ CONCORDIA PHARMS INC
EQ 1.5GM BASE/VIAL
AP
+
EQ 7.5GM BASE/VIAL
ZINACEF IN PLASTIC CONTAINER

+ CONCORDIA PHARMS INC
EQ 30MG BASE/ML
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

CEFUROXIME SODIUM

AB
FACTA FARMA
EQ 750MG BASE/VIAL
AB
HIKMA FARMACEUTICA
EQ 750MG BASE/VIAL
ZINACEF

AB
+ CONCORDIA PHARMS INC
EQ 750MG BASE/VIAL
CEFUROXIME SODIUM

AP
HOSPIRA INC
EQ 750MG BASE/VIAL
CELECOXIB

CAPSULE;ORAL

CELEBREX

AB
GD SEARLE
AB
AB
AB
+
CELECOXIB

AB
ALEMBIC PHARMS LTD
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
CIPLA LTD
AB
AB
AB
AB
LUPIN LTD
AB
AB

A065496
A065496
A065190
A065190
A065069
A065069
A065308
A065308
A065308
A065135
A065135
A065359
A065359
A065359
A065118
A065118
A065118
A065166
A065166
A065166

001
002
001
002
001
002
001
002
003
001
002
001
002
003
001
002
003
001
002
003

Jun
Jun
Oct
Oct
Oct
Oct
Mar
Mar
Mar
Jul
Jul
Feb
Feb
Feb
Apr
Apr
Apr
Jul
Jul
Jul

07,
07,
18,
18,
02,
02,
29,
29,
29,
25,
25,
15,
15,
15,
25,
25,
25,
29,
29,
29,

2010

2010

2004

2004

2002

2002

2006

2006

2006

2003

2003

2008

2008

2008

2003

2003

2003

2005

2005

2005

N050780 001 Feb 21, 2001

N050780 002 Feb 21, 2001

A064125
A064124
A065048
A065046
A065483
A065503
A065484

002
001
002
001
002
001
001

May
May
Jan
Jan
Oct
Oct
Oct

30,
30,
09,
09,
15,
15,
15,

1997

1997

2004

2004

2008

2008

2008

N050558 003 Oct 19, 1983

N050558 004 Oct 23, 1986

N050643 002 Apr 28, 1989

A064125 001 May 30, 1997

A065048 001 Jan 09, 2004

N050558 002 Oct 19, 1983

A065483 001 Oct 15, 2008

50MG
100MG
200MG
400MG

N020998
N020998
N020998
N020998

004
001
002
003

Dec
Dec
Dec
Aug

15,
31,
31,
29,

2006

1998

1998

2002

50MG
100MG
200MG
400MG
50MG
100MG
200MG
50MG
100MG
200MG
400MG
50MG
100MG
200MG

A204519
A204519
A204519
A204519
A204197
A204197
A204197
A207446
A207446
A207446
A207446
A202240
A202240
A202240

001
002
003
004
001
002
003
001
002
003
004
001
002
003

Aug
Aug
Aug
Aug
Jun
Jun
Jun
Sep
Sep
Sep
Sep
Oct
Jun
Jun

21,
21,
21,
21,
02,
02,
02,
23,
23,
23,
23,
29,
09,
09,

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2014

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-77(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CELECOXIB

CAPSULE;ORAL

CELECOXIB

AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
TORRENT PHARMS LTD
AB
AB
AB
AB
WATSON LABS INC
AB
AB
AB
CEPHALEXIN

CAPSULE;ORAL

CEPHALEXIN

AB
ALKEM LABS LTD
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
BELCHER PHARMS
AB
AB
HIKMA
AB
AB
LUPIN
AB
AB
ORCHID HLTHCARE
AB
AB
SUN PHARM INDS (IN)
AB
AB
SUN PHARM INDS LTD
AB
AB
TEVA
AB
AB
YUNG SHIN PHARM
AB
KEFLEX

AB
SHIONOGI INC
AB
AB
+
CEPHALEXIN

ALKEM LABS LTD
FOR SUSPENSION;ORAL

CEPHALEXIN

AB
LUPIN
AB
AB
ORCHID HLTHCARE
AB
AB
TEVA
AB
+
TABLET;ORAL

CEPHALEXIN

TEVA
+
CERITINIB

CAPSULE;ORAL

ZYKADIA

+ NOVARTIS PHARMS CORP

400MG
50MG
100MG
200MG
400MG
50MG
100MG
200MG
400MG
50MG
100MG
200MG
400MG
50MG
100MG
200MG
400MG

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
750MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A202240
A078857
A078857
A078857
A078857
A076898
A076898
A076898
A076898
A207677
A207677
A207677
A207677
A200562
A200562
A200562
A200562

004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Jun
May
Feb
Feb
Feb
May
May
May
May
Dec
Dec
Dec
Dec
Feb
Feb
Feb
Feb

09,
30,
11,
11,
11,
30,
30,
30,
30,
23,
23,
23,
23,
11,
11,
11,
11,

2015

2014

2015

2015

2015

2014

2014

2014

2014

2015

2015

2015

2015

2015

2015

2015

2015

A090836
A090836
A090836
A065253
A065253
A062713
A062713
A065215
A065215
A065229
A065229
A065248
A065248
A062791
A062791
A065007
A065007
A062702
A062702
A065152
A065152

001
002
004
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Dec
Dec
Mar
Nov
Nov
Jul
Jul
Jan
Jan
Nov
Nov
Jun
Jun
Jun
Jun
Sep
Sep
Feb
Feb
Feb
Feb

20,
20,
29,
16,
16,
15,
15,
24,
24,
25,
25,
28,
28,
11,
11,
16,
16,
13,
13,
24,
24,

2010

2010

2013

2005

2005

1988

1988

2006

2006

2005

2005

2005

2005

1987

1987

1999

1999

1987

1987

2005

2005

EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE

N050405 002

N050405 003

N050405 005 May 12, 2006

EQ 333MG BASE

A090836 003 Mar 29, 2013

EQ
EQ
EQ
EQ
EQ
EQ

A065234
A065234
A065326
A065326
A062703
A062703

125MG
250MG
125MG
250MG
125MG
250MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

001
002
001
002
001
002

Aug
Aug
Jul
Jul
Feb
Feb

17,
17,
10,
10,
13,
13,

2005

2005

2006

2006

1987

1987

EQ 250MG BASE
EQ 500MG BASE

A063023 001 Jan 12, 1989

A063024 001 Jan 12, 1989

150MG

N205755 001 Apr 29, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-78(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CETIRIZINE HYDROCHLORIDE

SYRUP;ORAL

CETIRIZINE HYDROCHLORIDE

AA
AMNEAL PHARMS
AA
BIO PHARM INC
AA
BRECKENRIDGE PHARM
AA
PERRIGO R AND D
AA
SILARX
AA
SUN PHARM INDS INC
AA
TARO
AA
TEVA PHARMS
AA
VINTAGE
AA
WOCKHARDT
ZYRTEC

AA
+ J AND J CONSUMER INC

5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML

A090766
A078870
A078488
A078398
A078876
A090191
A076601
A077279
A078496
A078757

5MG/5ML

N020346 001 Sep 27, 1996

CETRORELIX

INJECTABLE;INJECTION

CETROTIDE

+ EMD SERONO INC

EQ 0.25MG BASE/ML

N021197 001 Aug 11, 2000

30MG

A091260 001 Aug 25, 2011

001
001
001
001
001
001
001
001
001
001

Oct
Apr
Oct
Jun
May
Nov
Jun
May
Sep
Aug

07,
27,
06,
17,
11,
12,
20,
27,
25,
28,

2009

2009

2008

2008

2012

2009

2008

2008

2009

2009

CEVIMELINE HYDROCHLORIDE

CAPSULE;ORAL

CEVIMELINE

AB
APOTEX INC
CEVIMELINE HYDROCHLORIDE

AB
PACK PHARMS LLC
AB
ROXANE
EVOXAC

AB
+ DAIICHI SANKYO

30MG
30MG

A203775 001 Jun 04, 2014

A091591 001 Jul 08, 2013

30MG

N020989 002 Jan 11, 2000

CHENODIOL

TABLET;ORAL

CHENODIOL

+ NEXGEN PHARMA

250MG

A091019 001 Oct 22, 2009

CHLORAMBUCIL

TABLET;ORAL

LEUKERAN

+ ASPEN GLOBAL INC

2MG

N010669 002

CHLORAMPHENICOL SODIUM SUCCINATE

INJECTABLE;INJECTION

CHLORAMPHENICOL SODIUM SUCCINATE

+ FRESENIUS KABI USA
EQ 1GM BASE/VIAL
CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL

CHLORDIAZEPOXIDE HYDROCHLORIDE

AB
BARR
5MG
AB
10MG
AB
25MG
AB
USL PHARMA
10MG
LIBRIUM

AB
VALEANT PHARM INTL
5MG
AB
10MG
AB
+
25MG
CHLORHEXIDINE GLUCONATE

SOLUTION;DENTAL

CHLORHEXIDINE GLUCONATE

AT
HI TECH PHARMA
AT
LYNE
AT
TEVA
AT
WOCKHARDT
AT
XTTRIUM
PAROEX

AT
SUNSTAR AMERICAS
PERIDEX

AT
+ 3M
PERIOGARD

AT
COLGATE
TABLET;DENTAL

PERIOCHIP

+ DEXCEL PHARMA

A062365 001 Aug 25, 1982

A084768
A083116
A084769
A084623

001

001

001

001

A085461 001

A085472 001

A085475 001

0.12%
0.12%
0.12%
0.12%
0.12%

A074356
A074291
A074522
A075006
A077789

001
001
001
001
001

0.12%

A076434 001 Nov 29, 2005

0.12%

N019028 001 Aug 13, 1986

0.12%

A073695 001 Jan 14, 1994

2.5MG

N020774 001 May 15, 1998

May
Dec
Dec
Mar
Jun

07,
28,
15,
03,
18,

1996

1995

1995

2004

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-79(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CHLOROPROCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CHLOROPROCAINE HYDROCHLORIDE

AP
EUROHLTH INTL SARL
2%
AP
3%
AP
HOSPIRA
2%
AP
3%
NESACAINE

AP
FRESENIUS KABI USA
2%
NESACAINE-MPF

AP
+ FRESENIUS KABI USA
2%
AP
+
3%
NESACAINE

+ FRESENIUS KABI USA
1%
CHLOROQUINE PHOSPHATE

TABLET;ORAL

ARALEN

AA
+ SANOFI AVENTIS US
CHLOROQUINE PHOSPHATE

AA
+ HIKMA PHARMS LLC
AA
AA
IMPAX LABS
AA
AA
IPCA LABS LTD
AA
AA
NATCO PHARMA LTD
AA
CHLOROTHIAZIDE

SUSPENSION;ORAL

DIURIL

+ SALIX PHARMS
TABLET;ORAL

CHLOROTHIAZIDE

+ MYLAN
CHLOROTHIAZIDE SODIUM

INJECTABLE;INJECTION

CHLOROTHIAZIDE SODIUM

AP
FRESENIUS KABI USA
AP
LUITPOLD
AP
MYLAN INSTITUTIONAL
AP
SAGENT PHARMS
AP
SUN PHARMA GLOBAL
DIURIL

AP
+ OAK PHARMS AKORN

A040273
A040273
A087447
A087446

001
002
001
001

09,
09,
16,
16,

1998

1998

1982

1982

N009435 002

N009435 006 May 02, 1996

N009435 007 May 02, 1996

N009435 001

EQ 300MG BASE

N006002 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A083082
A083082
A080880
A040516
A090610
A090249
A091621
A090612

150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001

002
001

001
001
001
001
001

250MG/5ML

N011870 001

250MG
500MG

A084388 001

A084217 001

EQ
EQ
EQ
EQ
EQ

Sep
Sep
Apr
Apr

500MG
500MG
500MG
500MG
500MG

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

EQ 500MG BASE/VIAL

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

TABLET, EXTENDED RELEASE;ORAL

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE

SPRIASO LLC
8MG;54.3MG
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE

AA
TRIS PHARMA INC
4MG/5ML;5MG/5ML
VITUZ

AA
+ CYPRESS PHARM
4MG/5ML;5MG/5ML

A090896
A202561
A202493
A202462
A091546

001
001
001
001
001

Sep 17, 1999

Aug
Dec
Dec
Jan
Jan

29,
03,
03,
21,
21,

2003

2009

2009

2011

2011

Oct
Apr
Jun
May
Jul

16,
22,
18,
29,
26,

2009

2013

2014

2015

2011

N011145 005

N206323 001 Jun 22, 2015

A206438 001 Jan 27, 2015

N204307 001 Feb 20, 2013

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

AA
TRIS PHARMA INC
4MG/5ML;5MG/5ML;60MG/5ML
A203838 001 Nov
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

AA
PADDOCK LLC
4MG/5ML;5MG/5ML;60MG/5ML
A204627 001 Apr
HYDROCODONE BITARTRATE,CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

AA
COASTAL PHARMS
4MG/5ML;5MG/5ML;60MG/5ML
A205657 001 Aug
ZUTRIPRO

AA
+ CYPRESS PHARM
4MG/5ML;5MG/5ML;60MG/5ML
N022439 001 Jun

26, 2014

29, 2014

03, 2015

08, 2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-80(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

TUZISTRA XR

+ VERNALIS R AND D LTD
EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

CAPSULE, EXTENDED RELEASE;ORAL

TUSSICAPS

ECR PHARMA
EQ 4MG MALEATE;EQ 5MG BITARTRATE
+
EQ 8MG MALEATE;EQ 10MG BITARTRATE
SUSPENSION, EXTENDED RELEASE;ORAL

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

AB
TRIS PHARMA INC
EQ 8MG MALEATE/5ML;EQ 10MG
BITARTRATE/5ML

HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX

AB
NEOS THERAP INC
EQ 8MG MALEATE/5ML;EQ 10MG
BITARTRATE/5ML

TUSSIONEX PENNKINETIC

AB
+ UCB INC
EQ 8MG MALEATE/5ML;EQ 10MG
BITARTRATE/5ML

CHLORPROMAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

CHLORPROMAZINE HYDROCHLORIDE

+ EUROHLTH INTL SARL
25MG/ML
TABLET;ORAL

CHLORPROMAZINE HYDROCHLORIDE

BP
USL PHARMA
10MG
BP
25MG
BP
50MG
BP
100MG
BP
200MG

N207768 001 Apr 30, 2015

A077273 002 Sep 24, 2007

A077273 001 Sep 24, 2007

A091632 001 Oct 01, 2010

A091671 001 Jun 29, 2012

N019111 001 Dec 31, 1987

A083329 001

A083386
A084112
A084113
A084114
A084115

001

001

001

001

001

001
001
002
001

CHLORPROPAMIDE

TABLET;ORAL

CHLORPROPAMIDE

AB
ANI PHARMS INC
AB
AB
MYLAN
AB
DIABINESE

AB
PFIZER
AB
+

100MG
250MG
100MG
250MG

A088921
A088922
A088549
A088549

100MG
250MG

N011641 003

N011641 006

CHLORTHALIDONE

TABLET;ORAL

CHLORTHALIDONE

AB
+ MYLAN
AB
SUN PHARM INDS
MYLAN

50MG
50MG
25MG

A086831 001

A089286 001 Jul 21, 1986

A086831 002

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

TABLET;ORAL

CLORPRES

MYLAN
15MG;0.1MG
15MG;0.2MG
+
15MG;0.3MG
CHLORZOXAZONE

TABLET;ORAL

CHLORZOXAZONE

AA
BARR
AA
WATSON LABS
MIKART
CHOLESTYRAMINE

POWDER;ORAL

CHOLESTYRAMINE

AB
PAR PHARM
AB
AB
+ SANDOZ
AB
CHOLESTYRAMINE LIGHT

AB
PAR PHARM
AB

500MG
500MG
375MG
750MG

EQ
EQ
EQ
EQ

4GM
4GM
4GM
4GM

RESIN/PACKET
RESIN/SCOOPFUL
RESIN/PACKET
RESIN/SCOOPFUL

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

Apr
Apr
Jun
Jun

12,
12,
01,
01,

1985

1985

1984

1984

A071325 003 Feb 09, 1987

A071325 002 Feb 09, 1987

A071325 001 Feb 09, 1987

A089895
A089859
A040861
A040861

001
001
001
002

May
May
Jun
Jun

04,
04,
01,
01,

1988

1988

2010

2010

A077204
A077204
A074557
A074557

001
002
001
002

Aug
Aug
Aug
Aug

26,
26,
15,
15,

2005

2005

1996

1996

A077203 001 Aug 26, 2005

A077203 002 Aug 26, 2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-81(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CHOLESTYRAMINE

POWDER;ORAL

CHOLESTYRAMINE LIGHT

AB
+ SANDOZ
AB
PREVALITE

AB
UPSHER SMITH
AB

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

A074558 001 Aug 15, 1996

A074558 002 Aug 15, 1996

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

A073263 001 Feb 22, 1996

A073263 002 Oct 30, 1997

CHOLIC ACID

CAPSULE;ORAL

CHOLBAM

RTRX
+

50MG
250MG

N205750 001 Mar 17, 2015

N205750 002 Mar 17, 2015

CHOLINE C-11

INJECTABLE;INTRAVENOUS

CHOLINE C-11

AP
GLOBAL ISOTOPES LLC
AP
+ MCPRF
AP
UNIV TX MD ANDERSON

4-33.1mCi/ML
4-33.1mCi/ML
4-33.1mCi/ML

A206319 001 Nov 13, 2015

N203155 001 Sep 12, 2012

A205690 001 Oct 29, 2015

CHOLINE FENOFIBRATE

CAPSULE, DELAYED RELEASE;ORAL

FENOFIBRIC ACID

AB
ACTAVIS ELIZABETH
EQ
AB
EQ
AB
ANCHEN PHARMS
EQ
AB
EQ
AB
LUPIN LTD
EQ
AB
EQ
AB
MYLAN PHARMS INC
EQ
AB
EQ
TRILIPIX

AB
ABBVIE
EQ
AB
+
EQ
CHORIOGONADOTROPIN ALFA

INJECTABLE;SUBCUTANEOUS

OVIDREL

+ EMD SERONO

45MG FENOFIBRIC ACID

135MG FENOFIBRIC ACID
45MG FENOFIBRIC ACID
135MG FENOFIBRIC ACID
45MG FENOFIBRIC ACID
135MG FENOFIBRIC ACID
45MG FENOFIBRIC ACID
135MG FENOFIBRIC ACID

A200920
A200920
A201573
A201573
A200750
A200750
A200913
A200913

45MG FENOFIBRIC ACID

135MG FENOFIBRIC ACID

N022224 001 Dec 15, 2008

N022224 002 Dec 15, 2008

EQ 0.25MG /0.5ML

CHROMIC CHLORIDE

INJECTABLE;INJECTION

CHROMIC CHLORIDE IN PLASTIC CONTAINER

+ HOSPIRA
EQ 0.004MG CHROMIUM/ML
CICLESONIDE

AEROSOL, METERED;INHALATION

ALVESCO

TAKEDA GMBH
+
AEROSOL, METERED;NASAL

ZETONNA

+ TAKEDA GMBH
SPRAY, METERED;NASAL

OMNARIS

+ TAKEDA GMBH
CICLOPIROX

CREAM;TOPICAL

CICLOPIROX

AB
FOUGERA PHARMS
AB
G AND W LABS INC
AB
GLENMARK PHARMS
AB
PERRIGO
AB
TARO
LOPROX

AB
+ MEDIMETRIKS PHARMS
GEL;TOPICAL

CICLOPIROX

AB
FOUGERA PHARMS
AB
GLENMARK GENERICS
AB
PADDOCK LLC

001
002
002
001
001
002
001
002

Oct
Oct
Jul
Jul
Dec
Dec
Mar
Mar

07,
07,
18,
18,
04,
04,
25,
25,

2015

2015

2013

2013

2013

2013

2013

2013

N021149 002 Oct 06, 2003

N018961 001 Jun 26, 1986

0.08MG/INH
0.16MG/INH

N021658 002 Jan 10, 2008

N021658 003 Jan 10, 2008

0.037MG/INH

N202129 001 Jan 20, 2012

0.05MG/INH

N022004 001 Oct 20, 2006

0.77%
0.77%
0.77%
0.77%
0.77%

A076435
A078463
A090273
A077364
A076790

0.77%

N018748 001 Dec 30, 1982

0.77%
0.77%
0.77%

A077896 001 Jun 10, 2008

A091595 001 Feb 29, 2012

A078266 001 Jan 07, 2009

001
001
001
001
001

Dec
Dec
Nov
Mar
Apr

29,
20,
10,
03,
12,

2004

2010

2009

2006

2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-82(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CICLOPIROX

GEL;TOPICAL

LOPROX

AB
+ CNTY LINE PHARMS
SHAMPOO;TOPICAL

CICLOPIROX

AT
ACTAVIS MID ATLANTIC
AT
FOUGERA PHARMS
AT
PERRIGO
AT
TARO
LOPROX

AT
+ MEDICIS
SOLUTION;TOPICAL

CICLOPIROX

AT
ACTAVIS MID ATLANTIC
AT
APOTEX INC
AT
CIPLA LTD
AT
G AND W LABS
AT
HI TECH PHARMA
AT
PERRIGO NEW YORK
AT
TARO PHARM INDS
AT
TOLMAR
AT
VERSAPHARM
PENLAC

AT
+ VALEANT BERMUDA
SUSPENSION;TOPICAL

CICLOPIROX

AB
FOUGERA PHARMS
AB
PERRIGO NEW YORK
AB
TARO
LOPROX

AB
+ MEDIMETRIKS PHARMS
CIDOFOVIR

INJECTABLE;INJECTION

CIDOFOVIR

AP
EMCURE PHARMS LTD
AP
+ MYLAN INSTITUTIONAL

0.77%

N020519 001 Jul 21, 1997

1%
1%
1%
1%

A090490
A090146
A078594
A090269

1%

N021159 001 Feb 28, 2003

8%
8%
8%
8%
8%
8%
8%
8%
8%

A078046
A078172
A078124
A078233
A078270
A077623
A078144
A077687
A078975

8%

N021022 001 Dec 17, 1999

0.77%
0.77%
0.77%

A076422 001 Aug 06, 2004

A077676 001 Dec 15, 2006

A077092 001 Aug 10, 2005

0.77%

N019824 001 Dec 30, 1988

EQ 75MG BASE/ML
EQ 75MG BASE/ML

A202501 001 Jul 26, 2012

A201276 001 Jun 27, 2012

EQ 500MG BASE/VIAL;500MG/VIAL

N050630 001 Dec 14, 1990

EQ
EQ
EQ
EQ
EQ

A090577
A090577
A090825
A090825
A091007

001
001
001
001

001
001
001
001
001
001
001
001
001

Nov
May
Feb
Feb

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Feb

24,
25,
16,
23,

18,
18,
18,
18,
18,
18,
18,
18,
17,

2009

2010

2010

2011

2007

2007

2007

2007

2007

2007

2007

2007

2010

CILASTATIN SODIUM; IMIPENEM

POWDER;INTRAMUSCULAR

PRIMAXIN

MERCK
POWDER;INTRAVENOUS

IMIPENEM AND CILASTATIN

AP
ACS DOBFAR
AP
AP
HOSPIRA INC
AP
AP
PRIMAXIN

AP
+ MERCK
AP
+

EQ 250MG BASE/VIAL;250MG/VIAL
EQ 500MG BASE/VIAL;500MG/VIAL

N050587 001 Nov 26, 1985

N050587 002 Nov 26, 1985

CILOSTAZOL

TABLET;ORAL

CILOSTAZOL

AB
APOTEX INC
AB
AB
BIOKEY
AB
AB
BRECKENRIDGE PHARM
AB
AB
MYLAN
AB
AB
MYLAN PHARMS INC
AB
AB
PLIVA HRVATSKA DOO
AB
AB
ROXANE
AB
AB
SANDOZ
AB
AB
TEVA

50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG

A077030
A077030
A077722
A077831
A077708
A077708
A077323
A077323
A077019
A077019
A077898
A077898
A077024
A077024
A077310
A077021
A077027

250MG
500MG
250MG
500MG
500MG

BASE/VIAL;250MG/VIAL
BASE/VIAL;500MG/VIAL
BASE/VIAL;250MG/VIAL
BASE/VIAL;500MG/VIAL
BASE/VIAL;500MG/VIAL

001
002
001
002
001

001
002
001
001
001
002
002
001
001
002
001
002
001
002
001
001
001

Dec
Dec
Nov
Nov
Nov

Dec
Dec
Sep
Sep
Sep
Sep
Apr
Apr
Nov
Nov
Oct
Oct
May
May
Nov
Nov
Nov

21,
21,
16,
16,
16,

10,
10,
24,
24,
28,
28,
20,
20,
23,
23,
29,
29,
17,
17,
08,
23,
24,

2011

2011

2011

2011

2011

2004

2004

2012

2012

2009

2009

2006

2006

2004

2004

2007

2007

2005

2005

2005

2004

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-83(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CILOSTAZOL

TABLET;ORAL

CILOSTAZOL

AB
PLETAL

AB
+ OTSUKA
AB
+

100MG

A077027 002 Nov 24, 2004

50MG
100MG

N020863 001 Jan 15, 1999

N020863 002 Jan 15, 1999

CIMETIDINE

TABLET;ORAL

CIMETIDINE

AB
APOTEX
AB
AB
AB
AB
MYLAN
AB
AB
AB
+
AB
PLIVA
AB
TEVA
AB
AB
AB

200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
800MG
200MG
300MG
400MG
800MG

A074890
A074890
A074890
A074890
A074246
A074246
A074246
A074246
A074566
A074151
A074151
A074151
A074463

EQ 300MG BASE/2ML

A074428 001 Apr 25, 1996

EQ
EQ
EQ
EQ

A074610
A074664
A074553
A074757

CIMETIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

CIMETIDINE HYDROCHLORIDE

AP
DAVA PHARMS INC
SOLUTION;ORAL

CIMETIDINE HYDROCHLORIDE

AA
ANI PHARMS INC
AA
+ HI TECH PHARMA
AA
PHARM ASSOC
AA
WOCKHARDT
CINACALCET HYDROCHLORIDE

TABLET;ORAL

SENSIPAR

AMGEN
+

300MG
300MG
300MG
300MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

EQ 30MG BASE
EQ 60MG BASE
EQ 90MG BASE

CIPROFLOXACIN

FOR SUSPENSION;ORAL

CIPRO

AB
BAYER HLTHCARE
250MG/5ML
AB
+
500MG/5ML
CIPROFLOXACIN

AB
LUPIN LTD
250MG/5ML
AB
500MG/5ML
INJECTABLE;INJECTION

CIPRO

AP
+ BAYER HLTHCARE
400MG/40ML (10MG/ML)
AP
+
200MG/20ML (10MG/ML)
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ BAYER HLTHCARE
200MG/100ML
AP
+
400MG/200ML
CIPROFLOXACIN

AP
CLARIS PHARMASERVICE
200MG/20ML (10MG/ML)
AP
400MG/40ML (10MG/ML)
AP
HIKMA FARMACEUTICA
200MG/20ML (10MG/ML)
AP
400MG/40ML (10MG/ML)
AP
HOSPIRA
200MG/20ML (10MG/ML)
AP
400MG/40ML (10MG/ML)
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
ACS DOBFAR INFO SA
200MG/100ML
AP
400MG/200ML
AP
CLARIS PHARMASERVICE
200MG/100ML
AP
400MG/200ML
AP
HIKMA FARMACEUTICA
400MG/200ML
AP
HOSPIRA
200MG/100ML
AP
400MG/200ML

001
002
003
004
001
002
003
004
001
001
002
003
001

001
001
001
001

Dec
Dec
Dec
Dec
May
May
May
May
Feb
May
May
May
May

Sep
Oct
Jan
Oct

18,
18,
18,
18,
17,
17,
17,
17,
27,
17,
17,
17,
17,

26,
28,
27,
17,

1998

1998

1998

1998

1994

1994

1994

1994

1997

1994

1994

1994

1994

1996

1997

1997

1997

N021688 001 Mar 08, 2004

N021688 002 Mar 08, 2004

N021688 003 Mar 08, 2004

N020780 001 Sep 26, 1997

N020780 002 Sep 26, 1997

A200563 001 Mar 05, 2014

A200563 002 Mar 05, 2014

N019847 001 Dec 26, 1990

N019847 002 Dec 26, 1990

N019857 001 Dec 26, 1990

N019857 002 Dec 26, 1990

A078062
A078062
A076717
A076717
A077245
A077245

001
002
001
002
001
002

Apr
Apr
Dec
Dec
Aug
Aug

29,
29,
22,
22,
28,
28,

2008

2008

2009

2009

2006

2006

A078252
A078252
A078024
A078024
A078431
A077753
A077753

001
002
001
002
001
001
002

Mar
Mar
Mar
Mar
Nov
Mar
Mar

18,
18,
18,
18,
18,
18,
18,

2008

2008

2008

2008

2009

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-84(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CIPROFLOXACIN

INJECTABLE, SUSPENSION;OTIC

OTIPRIO

+ OTONOMY INC

6% (60MG/ML)

CIPROFLOXACIN HYDROCHLORIDE

OINTMENT;OPHTHALMIC

CILOXAN

+ ALCON PHARMS LTD
EQ
SOLUTION/DROPS;OPHTHALMIC

CILOXAN

AT
+ ALCON PHARMS LTD
EQ
CIPROFLOXACIN HYDROCHLORIDE

AT
AKORN INC
EQ
AT
FDC LTD
EQ
AT
IGI LABS INC
EQ
AT
PHARMAFORCE
EQ
AT
RISING PHARMS INC
EQ
AT
WATSON LABS INC
EQ
SOLUTION/DROPS;OTIC

CETRAXAL

+ WRASER PHARMS
EQ
TABLET;ORAL

CIPRO

AB
BAYER HLTHCARE
EQ
AB
EQ
AB
+
EQ
AB
EQ
CIPROFLOXACIN HYDROCHLORIDE

AB
APOTEX
EQ
AB
EQ
AB
EQ
AB
AUROBINDO PHARMA
EQ
AB
EQ
AB
EQ
AB
CARLSBAD
EQ
AB
EQ
AB
EQ
AB
DR REDDYS LABS LTD
EQ
AB
EQ
AB
EQ
AB
EQ
AB
HIKMA
EQ
AB
EQ
AB
EQ
AB
IVAX SUB TEVA PHARMS
EQ
AB
EQ
AB
EQ
AB
MYLAN
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
SUN PHARM INDS LTD
EQ
AB
EQ
AB
EQ
AB
TARO
EQ
AB
EQ
AB
EQ
AB
EQ
AB
UNIQUE PHARM LABS
EQ
AB
EQ
AB
EQ
AB
WATSON LABS
EQ
AB
EQ
AB
EQ
AB
EQ

N207986 001 Dec 10, 2015

0.3% BASE

N020369 001 Mar 30, 1998

0.3% BASE

N019992 001 Dec 31, 1990

0.3%
0.3%
0.3%
0.3%
0.3%
0.3%

A076555
A077568
A076754
A078598
A077689
A076673

BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001

Dec
Jun
Jun
Jan
Dec
Jan

11,
30,
09,
16,
13,
21,

2008

2008

2004

2008

2006

2005

0.2% BASE

N021918 001 May 01, 2009

100MG
250MG
500MG
750MG

BASE
BASE
BASE
BASE

N019537
N019537
N019537
N019537

001
002
003
004

Apr
Oct
Oct
Oct

08,
22,
22,
22,

1996

1987

1987

1987

250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
100MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
100MG
250MG
250MG
500MG
500MG
750MG
750MG
250MG
500MG
750MG
100MG
250MG
500MG
750MG
250MG
500MG
750MG
100MG
250MG
500MG
750MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A076896
A076896
A076896
A077859
A077859
A077859
A076126
A076126
A076126
A075593
A075593
A075593
A075593
A076558
A076558
A076558
A076089
A076089
A076089
A075817
A075685
A075817
A075685
A075817
A075685
A075817
A075747
A075747
A075747
A076912
A076912
A076912
A076912
A076639
A076639
A076639
A076794
A076794
A076794
A076794

001
002
003
001
002
003
002
003
004
002
003
004
001
002
003
004
002
003
004
001
002
002
003
003
001
004
001
002
003
001
002
003
004
001
002
003
001
002
003
004

Nov
Nov
Nov
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Feb
Oct
Oct
Oct
Sep
Sep
Sep
Feb
Jun
Jun
Jun

04,
04,
04,
26,
26,
26,
09,
09,
09,
09,
09,
09,
09,
09,
09,
09,
09,
09,
09,
25,
09,
09,
09,
09,
09,
09,
09,
09,
09,
18,
06,
06,
06,
10,
10,
10,
10,
09,
09,
09,

2004

2004

2004

2007

2007

2007

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2007

2004

2004

2004

2004

2004

2004

2004

2004

2004

2005

2004

2004

2004

2004

2004

2004

2005

2004

2004

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-85(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE

SUSPENSION/DROPS;OTIC

CIPRO HC

+ ALCON PHARMS LTD
EQ 0.2% BASE;1%
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CIPROFLOXACIN EXTENDED RELEASE

AB
ACTAVIS LABS FL INC
212.6MG;EQ 287.5MG
AB
425.2MG;EQ 574.9MG
AB
ANCHEN PHARMS
212.6MG;EQ 287.5MG
AB
425.2MG;EQ 574.9MG
AB
DR REDDYS LABS LTD
425.2MG;EQ 574.9MG
AB
+ MYLAN PHARMS INC
212.6MG;EQ 287.5MG
AB
+
425.2MG;EQ 574.9MG
CIPROFLOXACIN; DEXAMETHASONE

SUSPENSION/DROPS;OTIC

CIPRODEX

+ ALCON PHARMS LTD

0.3%;0.1%

N020805 001 Feb 10, 1998

BASE
BASE
BASE
BASE
BASE
BASE
BASE

A077417
A077809
A078166
A078166
A077701
A078183
A078183

001
001
002
001
001
001
002

Nov
Nov
Nov
Nov
Mar
Mar
Mar

30,
30,
27,
27,
26,
22,
22,

2010

2010

2007

2007

2007

2007

2007

N021537 001 Jul 18, 2003

CISATRACURIUM BESYLATE

INJECTABLE;INJECTION

CISATRACURIUM BESYLATE

AP
FRESENIUS KABI USA
EQ 2MG BASE/ML
AP
SANDOZ INC
EQ 2MG BASE/ML
CISATRACURIUM BESYLATE PRESERVATIVE FREE

AP
FRESENIUS KABI USA
EQ 2MG BASE/ML
AP
EQ 10MG BASE/ML
AP
SANDOZ INC
EQ 2MG BASE/ML
AP
EQ 10MG BASE/ML
NIMBEX

AP
+ ABBVIE
EQ 2MG BASE/ML
NIMBEX PRESERVATIVE FREE

AP
+ ABBVIE
EQ 2MG BASE/ML
AP
+
EQ 10MG BASE/ML

N020551 003 Dec 15, 1995

N020551 002 Dec 15, 1995

CISPLATIN

INJECTABLE;INJECTION

CISPLATIN

AP
ACCORD HLTHCARE
AP
EUROHLTH INTL SARL
AP
+ FRESENIUS KABI USA
AP
HQ SPCLT PHARMA
AP
MYLAN LABS LTD
AP
PHARMACHEMIE BV

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML

A206774
A075036
A074735
N018057
A091062
A074656

EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE

A077668 001 Feb 28, 2007

A077668 002 Feb 28, 2007

A077668 003 Feb 28, 2007

EQ
EQ
EQ
EQ

A077812
A201450
A077043
A077629

CITALOPRAM HYDROBROMIDE

CAPSULE;ORAL

CITALOPRAM HYDROBROMIDE

MYLAN PHARMS INC
+
SOLUTION;ORAL

CITALOPRAM HYDROBROMIDE

AA
AUROBINDO PHARMA LTD
AA
HETERO LABS LTD III
AA
+ ROXANE
AA
SILARX
TABLET;ORAL

CELEXA

AB
FOREST LABS
AB
AB
+
CITALOPRAM HYDROBROMIDE

AB
AMNEAL PHARMS NY
AB
AB
AB
APOTEX INC
AB
AB
AB
AUROBINDO
AB
AB
AB
CIPLA LTD

10MG
10MG
10MG
10MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A203183 001 Feb 26, 2015

A200159 001 Feb 03, 2012

A203182
A203182
A200154
A200154

001
002
001
002

Feb
Feb
Feb
Feb

26,
26,
03,
03,

2015

2015

2012

2012

N020551 001 Dec 15, 1995

001
001
001
004
001
001

001
001
001
001

Aug
Nov
Jul
Nov
Apr
May

Aug
Dec
Dec
Jun

18,
07,
16,
08,
18,
16,

28,
15,
13,
15,

2015

2000

1999

1988

2012

2000

2006

2015

2004

2006

EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE

N020822 001 Apr 27, 2000

N020822 002 Jul 17, 1998

N020822 003 Jul 17, 1998

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A077289
A077289
A077289
A077046
A077046
A077046
A077031
A077031
A077031
A077044

10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
003
001
002
003
001
002
003
001

Nov
Nov
Nov
Nov
Nov
Nov
Oct
Oct
Oct
Nov

30,
30,
30,
24,
24,
24,
28,
28,
28,
05,

2006

2006

2006

2004

2004

2004

2004

2004

2004

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-86(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CITALOPRAM HYDROBROMIDE

TABLET;ORAL

CITALOPRAM HYDROBROMIDE

AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
EPIC PHARMA
AB
AB
AB
G AND W LABS INC
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
JUBILANT GENERICS
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
PLIVA
AB
AB
AB
SUN PHARM INDS INC
AB
AB
AB
TORRENT PHARMS
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
10MG
20MG
20MG
40MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A077044
A077044
A077038
A077038
A077038
A077045
A077045
A077045
A077048
A077048
A077048
A077654
A077654
A077654
A077534
A077534
A077534
A205407
A205407
A205407
A077039
A077042
A077039
A077042
A077039
A077042
A077037
A077037
A077037
A077232
A077232
A077232
A077032
A077032
A077032
A078216
A078216
A078216

002
003
001
002
003
003
002
001
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003

Nov
Nov
Oct
Oct
Oct
Apr
Apr
Apr
Nov
Nov
Nov
Feb
Feb
Feb
Oct
Oct
Oct
Dec
Dec
Dec
Feb
Nov
Feb
Nov
Feb
Nov
Nov
Nov
Nov
Oct
Oct
Oct
Nov
Nov
Nov
Mar
Mar
Mar

05,
05,
28,
28,
28,
29,
29,
29,
16,
16,
16,
27,
27,
27,
03,
03,
03,
23,
23,
23,
03,
05,
03,
05,
03,
05,
05,
05,
05,
31,
31,
31,
12,
12,
12,
27,
27,
27,

2004

2004

2004

2004

2004

2005

2005

2005

2004

2004

2004

2009

2009

2009

2006

2006

2006

2015

2015

2015

2005

2004

2005

2004

2005

2004

2004

2004

2004

2005

2005

2005

2004

2004

2004

2007

2007

2007

CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE

SOLUTION;IRRIGATION

RENACIDIN

+ UNITED GUARDIAN
6.602GM/100ML;198MG/100ML;3.177GM/100ML

N019481 001 Oct 02, 1990

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

FOR SOLUTION;ORAL

PREPOPIK

+ FERRING PHARMS AS
12GM/PACKET;3.5GM/PACKET;10MG/PACKET

N202535 001 Jul 16, 2012

CITRIC ACID; UREA C-13

FOR SOLUTION, TABLET, FOR SOLUTION;ORAL

IDKIT:HP

+ EXALENZ BIOSCIENCE
N/A,4GM;75MG,N/A

N021314 001 Dec 17, 2002

CLADRIBINE

INJECTABLE;INJECTION

CLADRIBINE

AP
EUROHLTH INTL SARL
AP
+ FRESENIUS KABI USA
AP
MYLAN LABS LTD

1MG/ML
1MG/ML
1MG/ML

A075405 001 Feb 28, 2000

A076571 001 Apr 22, 2004

A200510 001 Oct 06, 2011

125MG/5ML
250MG/5ML

N050698 001 Dec 23, 1993

N050698 002 Dec 23, 1993

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML

A065283
A065283
A065382
A065382

CLARITHROMYCIN

FOR SUSPENSION;ORAL

BIAXIN

AB
ABBVIE
AB
+
CLARITHROMYCIN

AB
SANDOZ
AB
AB
SUN PHARM INDS LTD
AB

002
003
001
002

Sep
Sep
Aug
Aug

04,
04,
30,
30,

2007

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-87(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CLARITHROMYCIN

TABLET;ORAL

BIAXIN

AB
+ ABBVIE
250MG
AB
+
500MG
CLARITHROMYCIN

AB
ALLIED PHARMA INC
250MG
AB
500MG
AB
APOTEX CORP
250MG
AB
500MG
AB
AUROBINDO
250MG
AB
500MG
AB
HEC PHARM USA INC
250MG
AB
500MG
AB
MYLAN
250MG
AB
500MG
AB
ROXANE
250MG
AB
500MG
AB
SANDOZ
250MG
AB
500MG
AB
SUN PHARM INDS LTD
250MG
AB
500MG
AB
TEVA
250MG
AB
500MG
AB
WOCKHARDT
250MG
AB
500MG
TABLET, EXTENDED RELEASE;ORAL

CLARITHROMYCIN

AB
ACTAVIS LABS FL INC
500MG
AB
LUPIN LTD
500MG
AB
+ TEVA
500MG
CLEMASTINE FUMARATE

SYRUP;ORAL

CLEMASTINE FUMARATE

AA
+ TEVA
AA
WOCKHARDT
TABLET;ORAL

CLEMASTINE FUMARATE

AB
SANDOZ
AB
+ TEVA
CLEVIDIPINE

EMULSION;INTRAVENOUS

CLEVIPREX

+ THE MEDICINES CO
+
+
CLINDAMYCIN HYDROCHLORIDE

CAPSULE;ORAL

CLEOCIN HYDROCHLORIDE

AB
PHARMACIA AND UPJOHN
AB
AB
+
CLINDAMYCIN HYDROCHLORIDE

AB
AUROBINDO PHARMA
AB
AB
COREPHARMA
AB
AB
G AND W LABS INC
AB
AB
LANNETT
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
WATSON LABS
AB
AB
ZYDUS PHARMS USA
AB

N050662 001 Oct 31, 1991

N050662 002 Oct 31, 1991

A202710
A202710
A065384
A065384
A065489
A065489
A203584
A203584
A065195
A065195
A065178
A065178
A065144
A065136
A065174
A065174
A065155
A065155
A065266
A065266

001
002
001
002
001
002
001
002
001
002
002
001
001
001
001
002
001
002
001
002

Jun
Jun
Aug
Aug
Jul
Jul
Sep
Sep
Mar
Mar
May
May
Oct
Aug
Sep
Sep
May
May
May
May

10,
10,
20,
20,
25,
25,
28,
28,
11,
11,
25,
25,
18,
25,
24,
24,
31,
31,
31,
31,

2013

2013

2007

2007

2012

2012

2015

2015

2005

2005

2004

2004

2005

2005

2004

2004

2005

2005

2006

2006

A065145 001 Jun 24, 2004

A202532 001 Sep 15, 2015

A065154 001 May 18, 2005

EQ 0.5MG BASE/5ML
EQ 0.5MG BASE/5ML

A073399 001 Jun 30, 1994

A074863 001 Mar 13, 1998

2.68MG
2.68MG

A073459 001 Oct 31, 1993

A073283 001 Jan 31, 1992

25MG/50ML (0.5MG/ML)
50MG/100ML (0.5MG/ML)
125MG/250ML (0.5MG/ML)

N022156 001 Aug 01, 2008

N022156 002 Aug 01, 2008

N022156 003 Nov 08, 2013

EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE

N050162 001

N050162 002

N050162 003 Apr 14, 1988

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A065442
A065442
A065194
A065194
A063029
A063029
A065242
A065242
A065243
A091225
A091225
A091225
A065061
A065061
A063083
A063083
A065217
A065217

150MG BASE
300MG BASE
150MG BASE
300MG BASE
150MG BASE
300MG BASE
75MG BASE
150MG BASE
300MG BASE
75MG BASE
150MG BASE
300MG BASE
150MG BASE
300MG BASE
150MG BASE
300MG BASE
75MG BASE
150MG BASE

001
002
001
002
001
002
001
002
001
001
002
003
001
002
001
002
001
002

Aug
Aug
Mar
Mar
Sep
Aug
Aug
Aug
Aug
May
May
May
Feb
Feb
Jul
Mar
Jan
Jan

26,
26,
22,
22,
20,
05,
12,
12,
12,
31,
31,
31,
02,
02,
31,
18,
31,
31,

2009

2009

2004

2004

1989

2005

2005

2005

2005

2011

2011

2011

2001

2001

1991

2003

2005

2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-88(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CLINDAMYCIN HYDROCHLORIDE

CAPSULE;ORAL

CLINDAMYCIN HYDROCHLORIDE

AB

EQ 300MG BASE

CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION;ORAL

CLEOCIN

AA
+ PHARMACIA AND UPJOHN
EQ 75MG BASE/5ML
CLINDAMYCIN PALMITATE HYDROCHLORIDE

AA
AMNEAL PHARMS
EQ 75MG BASE/5ML
AA
AUROBINDO PHARMA LTD
EQ 75MG BASE/5ML
AA
LYNE
EQ 75MG BASE/5ML
AA
PADDOCK LABS
EQ 75MG BASE/5ML
CLINDAMYCIN PHOSPHATE

AEROSOL, FOAM;TOPICAL

CLINDAMYCIN PHOSPHATE

AT
PERRIGO UK FINCO
1%
EVOCLIN

AT
+ DELCOR ASSET
1%
CREAM;VAGINAL

CLEOCIN

AB
+ PHARMACIA AND UPJOHN
EQ 2% BASE
CLINDAMYCIN PHOSPHATE

AB
FOUGERA PHARMS
EQ 2% BASE
CLINDESSE

+ ELAN PHARMA INTL LTD
EQ 2% BASE
GEL;TOPICAL

CLEOCIN T

AB
+ PHARMACIA AND UPJOHN
EQ 1% BASE
CLINDAMYCIN PHOSPHATE

AB
FOUGERA PHARMS
EQ 1% BASE
CLINDAGEL

BT
+ PRECISION DERMAT
EQ 1% BASE
INJECTABLE;INJECTION

CLEOCIN PHOSPHATE

AP
PHARMACIA AND UPJOHN
EQ 150MG BASE/ML
AP
+
EQ 150MG BASE/ML
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ PHARMACIA AND UPJOHN
EQ 6MG BASE/ML
AP
+
EQ 12MG BASE/ML
AP
+
EQ 18MG BASE/ML
CLINDAMYCIN PHOSPHATE

AP
ALVOGEN INC
EQ 150MG BASE/ML
AP
EQ 150MG BASE/ML
AP
EQ 150MG BASE/ML
AP
BEDFORD
EQ 150MG BASE/ML
AP
FRESENIUS KABI USA
EQ 150MG BASE/ML
AP
EQ 150MG BASE/ML
AP
HIKMA MAPLE
EQ 150MG BASE/ML
AP
SAGENT PHARMS
EQ 150MG BASE/ML
AP
SAGENT STRIDES
EQ 150MG BASE/ML
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

AP
AKORN INC
EQ 6MG BASE/ML
AP
EQ 12MG BASE/ML
AP
EQ 18MG BASE/ML
AP
SANDOZ INC
EQ 6MG BASE/ML
AP
EQ 12MG BASE/ML
AP
EQ 18MG BASE/ML
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%

+ ABRAXIS PHARM
EQ 900MG BASE/100ML
LOTION;TOPICAL

CLEOCIN T

AB
+ PHARMACIA AND UPJOHN
EQ 1% BASE
CLINDAMYCIN PHOSPHATE

AB
FOUGERA PHARMS
EQ 1% BASE
SOLUTION;TOPICAL

CLEOCIN T

AT
+ PHARMACIA AND UPJOHN
EQ 1% BASE
CLINDA-DERM

AT
PADDOCK LLC
EQ 1% BASE

A065217 003 Jan 31, 2005

A062644 001 Apr 07, 1986

A203513
A202409
A201821
A090902

001
001
001
001

Mar
Apr
Aug
Jul

13,
30,
28,
07,

2014

2013

2012

2010

A090785 001 Mar 31, 2010

N050801 001 Oct 22, 2004

N050680 002 Mar 02, 1998

A065139 001 Dec 27, 2004

N050793 001 Nov 30, 2004

N050615 001 Jan 07, 1987

A064160 001 Jan 28, 2000

N050782 001 Nov 27, 2000

A062803 001 Oct 16, 1987

N050441 001

N050639 001 Aug 30, 1989

N050639 002 Aug 30, 1989

N050639 003 Apr 10, 1991

A062800
A062801
A062943
A065206
A065346
A065347
A062889
A090108
A090109

001
001
001
001
001
001
001
001
001

Jul
Jul
Sep
Sep
Mar
May
Apr
Sep
Sep

24,
24,
29,
24,
29,
09,
25,
30,
30,

1987

1987

1988

2004

2007

2007

1988

2011

2011

A203048
A203048
A203048
A201692
A201692
A201692

001
002
003
001
002
003

Apr
Apr
Apr
May
May
May

04,
04,
04,
31,
31,
31,

2013

2013

2013

2012

2012

2012

N050635 001 Dec 22, 1989

N050600 001 May 31, 1989

A065067 001 Jan 31, 2002

N050537 001

A063329 001 Sep 30, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-89(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CLINDAMYCIN PHOSPHATE

SOLUTION;TOPICAL

CLINDAMYCIN PHOSPHATE

AT
FOUGERA
AT
FOUGERA PHARMS
AT
G AND W LABS INC
AT
PERRIGO NEW YORK
AT
TARO PHARM INDS
AT
VINTAGE PHARMS
AT
WOCKHARDT
SUPPOSITORY;VAGINAL

CLEOCIN

+ PHARMACIA AND UPJOHN
SWAB;TOPICAL

CLEOCIN

AT
PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE

AT
PERRIGO NEW YORK
AT
VERSAPHARM
CLINDETS

AT
PERRIGO

EQ
EQ
EQ
EQ
EQ
EQ
EQ

1%
1%
1%
1%
1%
1%
1%

BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001

Jun
Feb
Sep
Nov
Mar
May
Jul

05,
14,
01,
30,
31,
29,
15,

1997

2006

1988

1995

2004

2015

1997

100MG

N050767 001 Aug 13, 1999

EQ 1% BASE

N050537 002 Feb 22, 1994

EQ 1% BASE
EQ 1% BASE

A065049 001 May 25, 2000

A065513 001 Jun 17, 2010

EQ 1% BASE

A064136 001 Sep 30, 1996

CLINDAMYCIN PHOSPHATE; TRETINOIN

GEL;TOPICAL

CLINDAMYCIN PHOSPHATE AND TRETINOIN

AB
ACTAVIS MID ATLANTIC
1.2%;0.025%
ZIANA

AB
+ MEDICIS
1.2%;0.025%
VELTIN

BX
+ STIEFEL GSK
1.2%;0.025%
CLOBAZAM

SUSPENSION;ORAL

ONFI

+ LUNDBECK LLC
TABLET;ORAL

ONFI

LUNDBECK LLC
+

A064159
A065254
A062811
A064050
A065184
A203343
A063304

A202564 001 Jun 12, 2015

N050802 001 Nov 07, 2006

N050803 001 Jul 16, 2010

2.5MG/ML

N203993 001 Dec 14, 2012

10MG
20MG

N202067 002 Oct 21, 2011

N202067 003 Oct 21, 2011

CLOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL

CLOBETASOL PROPIONATE

AB1
PERRIGO ISRAEL
0.05%
OLUX

AB1 + DELCOR ASSET
0.05%
CLOBETASOL PROPIONATE

AB2
PERRIGO ISRAEL
0.05%
OLUX E

AB2 + DELCOR ASSET
0.05%
CREAM;TOPICAL

CLOBETASOL PROPIONATE

AB1
FOUGERA
0.05%
AB1
G AND W LABS INC
0.05%
AB1
TARO
0.05%
CORMAX

AB1 + HI TECH PHARMA
0.05%
CLOBETASOL PROPIONATE (EMOLLIENT)

AB2 + FOUGERA PHARMS

0.05%
AB2
TARO
0.05%
EMBELINE E

AB2
HI TECH PHARMA
0.05%
GEL;TOPICAL

CLOBETASOL PROPIONATE

AB
+ FOUGERA PHARMS
0.05%
AB
PERRIGO
0.05%
AB
TARO
0.05%
EMBELINE

AB
HI TECH PHARMA
0.05%
LOTION;TOPICAL

CLOBETASOL PROPIONATE

AB
ACTAVIS MID ATLANTIC
0.05%
AB
TARO
0.05%

A077763 001 Mar 10, 2008

N021142 001 May 26, 2000

A201402 001 Aug 14, 2012

N022013 001 Jan 12, 2007

A074392 001 Sep 30, 1996

A074139 001 Aug 03, 1994

A074249 001 Jul 08, 1996

A074220 001 May 16, 1997

A075430 001 May 26, 1999

A075633 001 May 17, 2000

A075325 001 Dec 24, 1998

A075368 001 Feb 15, 2000

A075027 001 Oct 31, 1997

A075279 001 May 28, 1999

A076141 001 Apr 12, 2002

A078223 001 Dec 04, 2008

A200302 001 Jul 02, 2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-90(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CLOBETASOL PROPIONATE

LOTION;TOPICAL

CLOBEX

AB
+ GALDERMA LABS LP
OINTMENT;TOPICAL

CLOBETASOL PROPIONATE

AB
FOUGERA PHARMS
AB
G AND W LABS INC
AB
TARO
EMBELINE

AB
HI TECH PHARMA
TEMOVATE

AB
+ FOUGERA PHARMS
SHAMPOO;TOPICAL

CLOBETASOL PROPIONATE

AB
ACTAVIS MID ATLANTIC
AB
PERRIGO ISRAEL
CLOBEX

AB
+ GALDERMA LABS
SOLUTION;TOPICAL

CLOBETASOL PROPIONATE

AT
FOUGERA PHARMS
AT
G AND W LABS INC
AT
NOVEL LABS INC
AT
TARO
AT
AT
TOLMAR
AT
WOCKHARDT
EMBELINE

AT
+ HI TECH PHARMA
SPRAY;TOPICAL

CLOBETASOL PROPIONATE

AT
PADDOCK LLC
CLOBEX

AT
+ GALDERMA LABS LP
CLOCORTOLONE PIVALATE

CREAM;TOPICAL

CLODERM

+ PROMIUS PHARMA LLC
CLOFARABINE

INJECTABLE;IV (INFUSION)

CLOLAR

+ GENZYME
CLOFAZIMINE

CAPSULE;ORAL

LAMPRENE

+ NOVARTIS
CLOMIPHENE CITRATE

TABLET;ORAL

CLOMID

AB
+ SANOFI AVENTIS US
CLOMIPHENE CITRATE

AB
PAR PHARM
CLOMIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

ANAFRANIL

AB
MALLINCKRODT LLC
AB
+
AB
CLOMIPRAMINE HYDROCHLORIDE

AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB
TARO
AB
AB
AB
TEVA

0.05%

N021535 001 Jul 24, 2003

0.05%
0.05%
0.05%

A074407 001 Feb 23, 1996

A074089 001 Feb 16, 1994

A074248 001 Jul 12, 1996

0.05%

A074221 001 Mar 31, 1995

0.05%

N019323 001 Dec 27, 1985

0.05%
0.05%

A078854 001 Jun 07, 2011

A090974 001 Aug 09, 2012

0.05%

N021644 001 Feb 05, 2004

0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%

A075391
A074331
A206075
A075224
A075363
A076977
A075205

0.05%

A074222 001 Dec 06, 1995

0.05%

A090898 001 Jun 16, 2011

0.05%

N021835 001 Oct 27, 2005

0.1%

N017765 001

20MG/20ML (1MG/ML)

N021673 001 Dec 28, 2004

50MG

N019500 002 Dec 15, 1986

50MG

N016131 002

50MG

A075528 001 Aug 30, 1999

25MG
50MG
75MG

N019906 001 Dec 29, 1989

N019906 002 Dec 29, 1989

N019906 003 Dec 29, 1989

25MG
50MG
75MG
25MG
50MG
75MG
25MG
50MG
75MG
25MG

A074947
A074947
A074947
A074364
A074364
A074364
A074694
A074694
A074694
A074958

001
001
001
001
001
001
001

001
002
003
001
002
003
001
002
003
001

Feb
Dec
Nov
Nov
Dec
Aug
Nov

Apr
Apr
Apr
Mar
Mar
Mar
Dec
Dec
Dec
Aug

08,
15,
23,
16,
29,
05,
13,

30,
30,
30,
29,
29,
29,
31,
31,
31,
26,

1999

1995

2015

1998

2000

2005

1998

1998

1998

1998

1996

1996

1996

1996

1996

1996

1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-91(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CLOMIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

CLOMIPRAMINE HYDROCHLORIDE

AB
50MG
AB
75MG
CLONAZEPAM

TABLET;ORAL

CLONAZEPAM

AB
ACCORD HLTHCARE
0.5MG
AB
1MG
AB
2MG
AB
ACTAVIS ELIZABETH
0.5MG
AB
1MG
AB
2MG
AB
MYLAN
0.5MG
AB
1MG
AB
2MG
AB
MYLAN PHARMS INC
0.5MG
AB
1MG
AB
2MG
AB
SANDOZ
0.5MG
AB
1MG
AB
2MG
AB
SUN PHARM INDS INC
0.5MG
AB
1MG
AB
2MG
AB
TEVA
0.5MG
AB
1MG
AB
2MG
AB
VINTAGE PHARMS
0.5MG
AB
1MG
AB
2MG
AB
WATSON LABS
0.5MG
AB
1MG
AB
2MG
KLONOPIN

AB
ROCHE
0.5MG
AB
+
1MG
AB
2MG
TABLET, ORALLY DISINTEGRATING;ORAL

CLONAZEPAM

AB
BARR
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
PAR PHARM
0.125MG
AB
0.25MG
AB
0.5MG
AB
+
1MG
AB
2MG
AB
SUN PHARM INDS INC
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
CLONIDINE

FILM, EXTENDED RELEASE;TRANSDERMAL

CATAPRES-TTS-1

AB
BOEHRINGER INGELHEIM
0.1MG/24HR
CATAPRES-TTS-2

0.2MG/24HR
AB
BOEHRINGER INGELHEIM
CATAPRES-TTS-3

AB
+ BOEHRINGER INGELHEIM
0.3MG/24HR
CLONIDINE

AB
ACTAVIS LABS UT INC
0.1MG/24HR
AB
0.2MG/24HR
AB
0.3MG/24HR
AB
AVEVA
0.1MG/24HR
AB
0.2MG/24HR
AB
0.3MG/24HR

A074958 002 Aug 26, 1997

A074958 003 Aug 26, 1997

A077147
A077147
A077147
A074869
A074869
A074869
A075150
A075150
A075150
A074940
A074940
A074940
A074979
A074979
A074979
A075423
A075423
A075423
A074569
A074569
A074569
A077856
A077856
A077856
A074964
A074964
A074964

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

May
May
May
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug
Aug
Apr
Apr
Apr
Sep
Sep
Sep
Jun
Jun
Jun
Dec
Dec
Dec

02,
02,
02,
31,
31,
31,
05,
05,
05,
30,
30,
30,
29,
29,
29,
27,
27,
27,
10,
10,
10,
28,
28,
28,
30,
30,
30,

2005

2005

2005

1996

1996

1996

1998

1998

1998

1997

1997

1997

1997

1997

1997

2001

2001

2001

1996

1996

1996

2006

2006

2006

1997

1997

1997

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

10,
10,
10,
10,
10,
03,
03,
03,
03,
03,
27,
27,
27,
27,
27,

2005

2005

2005

2005

2005

2005

2005

2005

2005

2005

2014

2014

2014

2014

2014

N017533 001

N017533 002

N017533 003

A077194
A077194
A077194
A077194
A077194
A077171
A077171
A077171
A077171
A077171
A078654
A078654
A078654
A078654
A078654

001
002
003
004
005
001
002
003
004
005
001
002
003
004
005

N018891 001 Oct 10, 1984

N018891 002 Oct 10, 1984

N018891 003 Oct 10, 1984

A090873
A090873
A090873
A076157
A076157
A076157

001
002
003
001
002
003

May
May
May
Aug
Aug
Aug

06,
06,
06,
18,
18,
18,

2014

2014

2014

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-92(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CLONIDINE

FILM, EXTENDED RELEASE;TRANSDERMAL

CLONIDINE

AB
BARR

0.1MG/24HR

AB

0.2MG/24HR

AB

0.3MG/24HR

AB
MYLAN TECHNOLOGIES

0.1MG/24HR

AB

0.2MG/24HR

AB

0.3MG/24HR

CLONIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

CLONIDINE HYDROCHLORIDE

AP
EXELA PHARMA SCS LLC
1MG/10ML
AP

5MG/10ML
AP
FRESENIUS KABI USA

1MG/10ML
AP

5MG/10ML
AP
HIKMA FARMACEUTICA

1MG/10ML
AP

5MG/10ML
AP
LUITPOLD

1MG/10ML
AP

5MG/10ML
AP
ZYDUS PHARMS USA INC
1MG/10ML
AP

5MG/10ML
DURACLON

AP
MYLAN INSTITUTIONAL

1MG/10ML
AP
+

5MG/10ML
TABLET;ORAL

CATAPRES

AB
BOEHRINGER INGELHEIM
0.1MG

AB

0.2MG

AB
+

0.3MG

CLONIDINE HYDROCHLORIDE

AB
ACTAVIS ELIZABETH

0.1MG

AB

0.2MG

AB

0.3MG

AB
ALEMBIC PHARMS LTD

0.1MG

AB

0.2MG

AB

0.3MG

AB
CARLSBAD

0.1MG

AB

0.2MG

AB

0.3MG

AB
IMPAX LABS

0.1MG

AB

0.2MG

AB

0.3MG

AB
MYLAN

0.1MG

AB

0.2MG

AB

0.3MG

AB
SUN PHARM INDS

0.1MG

AB

0.2MG

AB

0.3MG

AB
SUN PHARM INDS INC

0.1MG

AB

0.2MG

AB

0.3MG

AB
UNICHEM

0.1MG

AB

0.2MG

AB

0.3MG

AB
VINTAGE

0.1MG

AB

0.2MG

AB

0.3MG

TABLET, EXTENDED RELEASE;ORAL

CLONIDINE HYDROCHLORIDE

AB1
ACTAVIS ELIZABETH

0.1MG

CLONIDINE HYDROCHLORIDE

AB1
ANCHEN PHARMS

0.1MG

KAPVAY

AB1 + CONCORDIA PHARMS INC
0.1MG

CLONIDINE HYDROCHLORIDE

AB2
ACTAVIS ELIZABETH

0.1MG

A079090
A079090
A079090
A076166
A076166
A076166

001
002
003
001
002
003

Aug
Aug
Aug
Jul
Jul
Jul

20,
20,
20,
16,
16,
16,

2010

2010

2010

2010

2010

2010

(0.1MG/ML)

(0.5MG/ML)

(0.1MG/ML)

(0.5MG/ML)

(0.1MG/ML)

(0.5MG/ML)

(0.1MG/ML)

(0.5MG/ML)

(0.1MG/ML)

(0.5MG/ML)

A203167
A203167
A200673
A200673
A200300
A200300
A091104
A091104
A202601
A202601

001
002
001
002
001
002
001
002
001
002

Oct
Oct
Jul
Jul
Jan
Jan
Oct
Oct
Feb
Feb

29,
29,
08,
08,
26,
26,
08,
08,
20,
20,

2013

2013

2011

2011

2011

2011

2009

2009

2014

2014

(0.1MG/ML)

(0.5MG/ML)

N020615 001 Oct 02, 1996

N020615 002 Apr 27, 1999

N017407 001

N017407 002

N017407 003

A070974
A070975
A070976
A091368
A091368
A091368
A202297
A202297
A202297
A078099
A078099
A078099
A070317
A070317
A070317
A070925
A070924
A070923
A090329
A090329
A090329
A078895
A078895
A078895
A077901
A077901
A077901

001
001
001
001
002
003
001
002
003
001
002
003
002
003
001
001
001
001
001
002
003
001
002
003
001
002
003

Dec
Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Aug
Aug
Aug
Jul
Jun
Jun
Sep
Sep
Sep
Jul
Jul
Jul
Aug
Aug
Aug
Mar
Mar
Mar

16,
16,
16,
06,
06,
06,
13,
13,
13,
27,
27,
27,
09,
09,
09,
04,
04,
04,
03,
03,
03,
26,
26,
26,
09,
09,
09,

1986

1986

1986

2011

2011

2011

2013

2013

2013

2009

2009

2009

1987

1987

1987

1987

1987

1987

2014

2014

2014

2009

2009

2009

2007

2007

2007

A203320 001 May 15, 2015

A202984 001 Sep 30, 2013

N022331 003 Sep 28, 2010

A202792 001 May 15, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-93(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CLOPIDOGREL BISULFATE

TABLET;ORAL

CLOPIDOGREL BISULFATE

AB
ACCORD HLTHCARE

AB

AB
ACTAVIS TOTOWA

AB
AMNEAL PHARMS

AB
APOTEX INC

AB

AB
AUROBINDO PHARMA LTD

AB
DR REDDYS LABS INC

AB
DR REDDYS LABS LTD

AB
GATE PHARMS

AB
MACLEODS PHARMS LTD

AB
MUTUAL PHARM

AB
MYLAN PHARMS INC

AB

AB
ROXANE

AB
SCIEGEN PHARMS INC

AB

AB
SUN PHARMA GLOBAL

AB
TEVA

AB
TEVA PHARMS

AB
TORRENT PHARMS LTD

AB
WOCKHARDT LTD

AB

AB
ZYDUS PHARMS USA INC

PLAVIX

AB
SANOFI AVENTIS US

AB
+

CLORAZEPATE DIPOTASSIUM

TABLET;ORAL

CLORAZEPATE DIPOTASSIUM

AB
MYLAN

AB

AB

AB
SUN PHARM INDS LTD

AB

AB

AB
TARO

AB

AB

GEN-XENE

AB
ALRA

AB

AB

TRANXENE

AB
RECORDATI RARE

AB

AB
+

CLOTRIMAZOLE

CREAM;TOPICAL

CLOTRIMAZOLE

AB
FOUGERA PHARMS

AB
GLENMARK PHARMS

AB
+ TARO

SOLUTION;TOPICAL

CLOTRIMAZOLE

AT
+ TARO

AT
TEVA

TROCHE/LOZENGE;ORAL

CLOTRIMAZOLE

AB
PADDOCK LLC

AB
+ ROXANE

CLOZAPINE

SUSPENSION;ORAL

VERSACLOZ

+ JAZZ PHARMS III

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

75MG BASE

300MG BASE

75MG BASE

75MG BASE

75MG BASE

300MG BASE

75MG BASE

75MG BASE

300MG BASE

300MG BASE

75MG BASE

75MG BASE

75MG BASE

300MG BASE

75MG BASE

75MG BASE

300MG BASE

75MG BASE

75MG BASE

300MG BASE

75MG BASE

75MG BASE

300MG BASE

75MG BASE

A202925
A202925
A090307
A203751
A076274
A076274
A090540
A076273
A091023
A091216
A202928
A078133
A077665
A077665
A078004
A204165
A204165
A090494
A076999
A090625
A090844
A202266
A202266
A201686

001
002
001
001
001
002
001
001
001
001
001
001
001
002
001
001
002
001
001
001
001
001
002
001

Mar
Mar
May
Apr
May
Mar
May
Jan
May
May
Feb
Jun
May
May
May
Sep
Sep
May
May
May
May
Aug
Nov
Oct

27,
27,
28,
11,
17,
04,
17,
14,
17,
17,
10,
10,
17,
17,
17,
15,
15,
17,
17,
17,
17,
14,
20,
10,

2013

2013

2013

2014

2012

2014

2012

2008

2012

2012

2014

2013

2012

2012

2012

2014

2014

2012

2012

2012

2012

2012

2012

2012

EQ 75MG BASE

EQ 300MG BASE

N020839 001 Nov 17, 1997

N020839 002 Sep 20, 2007

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

A071858
A071858
A071858
A076911
A076911
A076911
A075731
A075731
A075731

3.75MG

7.5MG

15MG

A071787 001 Apr 26, 1988

A071788 001 Apr 26, 1988

A071789 001 Apr 26, 1988

3.75MG

7.5MG

15MG

N017105 006

N017105 007

N017105 008

1%

1%

1%

A078338 001 Sep 02, 2008

A090219 001 Aug 03, 2010

A072640 001 Aug 31, 1993

1%

1%

A074580 001 Jul 29, 1996

A073306 001 Feb 28, 1995

10MG

10MG

A076763 001 Oct 28, 2005

A076387 001 Jul 29, 2004

50MG/ML

N203479 001 Feb 06, 2013

002
003
001
001
002
003
003
002
001

Jul
Jul
Jul
Sep
Sep
Sep
Apr
Apr
Apr

17,
17,
17,
29,
29,
29,
27,
27,
27,

1987

1987

1987

2004

2004

2004

2000

2000

2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-94(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CLOZAPINE
TABLET;ORAL
CLOZAPINE
AB
ACCORD HLTHCARE
25MG
AB
100MG
AB
ACTAVIS LABS FL INC
25MG
AB
100MG
AB
IVAX SUB TEVA PHARMS
12.5MG
AB
25MG
AB
50MG
AB
50MG
AB
100MG
AB
100MG
AB
200MG
AB
MYLAN
12.5MG
AB
25MG
AB
50MG
AB
100MG
AB
200MG
AB
SUN PHARM INDS INC
25MG
AB
50MG
AB
100MG
CLOZARIL
AB
HERITAGE LIFE
25MG
AB
+
100MG
TABLET, ORALLY DISINTEGRATING;ORAL

CLOZAPINE

AB
BARR LABS INC

25MG

AB

100MG

AB
MYLAN PHARMS INC

25MG

AB

100MG

AB
TEVA PHARMS USA

150MG

AB

200MG

FAZACLO ODT

AB
JAZZ PHARMS III

25MG

AB
+

100MG

AB

150MG

AB

200MG

12.5MG

COBICISTAT

TABLET;ORAL

TYBOST

+ GILEAD SCIENCES INC

150MG

A202873
A202873
A203807
A203807
A074949
A074949
A074949
A076809
A074949
A076809
A076809
A075417
A075417
A075417
A075417
A075417
A075713
A075713
A075713

001
002
001
002
003
001
004
003
002
002
001
003
001
004
002
005
001
003
002

Nov
Nov
Sep
Sep
Jul
Nov
Apr
Dec
Nov
Dec
Dec
Apr
May
Apr
May
Apr
Nov
Aug
Nov

25,
25,
17,
17,
31,
26,
25,
16,
26,
16,
16,
15,
27,
15,
27,
15,
15,
19,
15,

2015

2015

2015

2015

2003

1997

2005

2005

1997

2005

2005

2010

1999

2010

1999

2010

2002

2005

2002

N019758 001 Sep 26, 1989

N019758 002 Sep 26, 1989

A090308
A090308
A201824
A201824
A203039
A203039

001
002
002
003
001
002

Nov
Nov
Sep
Sep
Nov
Nov

25,
25,
15,
15,
25,
25,

2015

2015

2015

2015

2015

2015

N021590
N021590
N021590
N021590
N021590

001
002
005
006
004

Feb
Feb
Jul
Jul
May

10,
10,
09,
09,
30,

2004

2004

2010

2010

2007

N203094 001 Sep 24, 2014

COBICISTAT; DARUNAVIR ETHANOLATE

TABLET;ORAL

PREZCOBIX

+ JANSSEN PRODS
150MG;EQ 800MG BASE

N205395 001 Jan 29, 2015

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL

GENVOYA

+ GILEAD SCIENCES INC
150MG;150MG;200MG;EQ 10MG BASE

N207561 001 Nov 05, 2015

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

STRIBILD

+ GILEAD SCIENCES INC

150MG;150MG;200MG;300MG

N203100 001 Aug 27, 2012

COBIMETINIB FUMARATE

TABLET;ORAL

COTELLIC

+ GENENTECH INC

N206192 001 Nov 10, 2015

EQ 20MG BASE

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

AA
VINTAGE
10MG/5ML;5MG/5ML;6.25MG/5ML
A040660
PROMETH VC W/ CODEINE

AA
+ ACTAVIS MID ATLANTIC
10MG/5ML;5MG/5ML;6.25MG/5ML
A088764
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

AA
HI-TECH PHARMA CO
10MG/5ML;5MG/5ML;6.25MG/5ML
A040674
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

AA
AMNEAL PHARMS
10MG/5ML;5MG/5ML;6.25MG/5ML
A200963

001 Dec 07, 2006

001 Oct 31, 1984

001 Dec 23, 2014

001 Aug 26, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-95(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

AA
+ ACTAVIS MID ATLANTIC
10MG/5ML;6.25MG/5ML

AA
AMNEAL PHARMS
10MG/5ML;6.25MG/5ML

AA
HI TECH PHARMA
10MG/5ML;6.25MG/5ML

AA
SUN PHARM INDS INC
10MG/5ML;6.25MG/5ML

AA
TRIS PHARMA INC
10MG/5ML;6.25MG/5ML

AA
WOCKHARDT
10MG/5ML;6.25MG/5ML

PROMETHAZINE WITH CODEINE

AA
VINTAGE
10MG/5ML;6.25MG/5ML

A088763
A200894
A040151
A090180
A200386
A088875

001
001
001
001
001
001

Oct
Apr
Aug
Mar
Jun
Dec

31,
24,
26,
17,
29,
17,

1984

2013

1997

2010

2012

1984

A040650 001 Jan 31, 2006

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP;ORAL

TRIACIN-C

+ STI PHARMA LLC

10MG/5ML;30MG/5ML;1.25MG/5ML

A088704 001 Mar 22, 1985

CODEINE SULFATE

TABLET;ORAL

CODEINE SULFATE

AB
LANNETT HOLDINGS INC
AB
AB
AB
ROXANE
AB
AB
+
COLCHICINE

CAPSULE;ORAL

MITIGARE

HIKMA INTL PHARMS

TABLET;ORAL

COLCRYS

+ TAKEDA PHARMS USA

COLCHICINE; PROBENECID

TABLET;ORAL

COL-PROBENECID

AB
+ WATSON LABS

PROBENECID AND COLCHICINE

AB
MIRROR PHARMS

COLESEVELAM HYDROCHLORIDE

FOR SUSPENSION;ORAL

WELCHOL

DAIICHI SANKYO

+

TABLET;ORAL

WELCHOL

+ DAIICHI SANKYO

COLESTIPOL HYDROCHLORIDE

GRANULE;ORAL

COLESTID

AB
PHARMACIA AND UPJOHN

AB
+

COLESTIPOL HYDROCHLORIDE

AB
IMPAX LABS

AB

FLAVORED COLESTID

PHARMACIA AND UPJOHN

TABLET;ORAL

COLESTID

AB
+ PHARMACIA AND UPJOHN

COLESTIPOL HYDROCHLORIDE

AB
IMPAX LABS

COLISTIMETHATE SODIUM

INJECTABLE;INJECTION

COLISTIMETHATE SODIUM

AP
EMCURE PHARMS LTD

AP
FRESENIUS KABI USA

AP
PADDOCK LLC

AP
SAGENT PHARMS

AP
X GEN PHARMS

15MG

30MG

60MG

15MG

30MG

60MG

A203046
A203046
A203046
N022402
N022402
N022402

0.6MG

N204820 001 Sep 26, 2014

0.6MG

N022352 001 Jul 29, 2009

0.5MG;500MG

A084279 001

0.5MG;500MG

A040618 001 May 13, 2008

1.875GM/PACKET

3.75GM/PACKET

N022362 001 Oct 02, 2009

N022362 002 Oct 02, 2009

625MG

N021176 001 May 26, 2000

5GM/SCOOPFUL

5GM/PACKET

N017563 003 Sep 22, 1995

N017563 004 Sep 22, 1995

5GM/SCOOPFUL

5GM/PACKET

A077277 001 May 02, 2006

A077277 002 May 02, 2006

5GM/PACKET

5GM/SCOOPFUL

N017563 001

N017563 002

1GM

N020222 001 Jul 19, 1994

1GM

A077510 001 Oct 24, 2006

EQ
EQ
EQ
EQ
EQ

150MG
150MG
150MG
150MG
150MG

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

A202359
A065364
A065177
A201365
A064216

001
002
003
001
002
003

001
001
001
001
001

Jun
Jun
Jun
Jul
Jul
Jul

Sep
Apr
Mar
Feb
Feb

13,
13,
13,
16,
16,
16,

28,
17,
19,
19,
26,

2014

2014

2014

2009

2009

2009

2012

2008

2004

2014

1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-96(of 388)

PRESCRIPTION DRUG PRODUCT LIST

COLISTIMETHATE SODIUM

INJECTABLE;INJECTION

COLISTIMETHATE SODIUM

AP
XELLIA PHARMS APS
COLY-MYCIN M

AP
+ PAR STERILE PRODUCTS

EQ 150MG BASE/VIAL

A205356 001 May 29, 2015

EQ 150MG BASE/VIAL

N050108 002

COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE

SUSPENSION/DROPS;OTIC

COLY-MYCIN S

+ PAR STERILE PRODUCTS
EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG
N050356 001

BASE/ML;0.5MG/ML

CONIVAPTAN HYDROCHLORIDE

INJECTABLE;IV (INFUSION)

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER

+ CUMBERLAND PHARMS
20MG/100ML (0.2MG/ML)

N021697 002 Oct 08, 2008

COPPER

INTRAUTERINE DEVICE;INTRAUTERINE

PARAGARD T 380A

+ TEVA WOMENS
309MG/COPPER

N018680 001 Nov 15, 1984

CORTICORELIN OVINE TRIFLUTATE

INJECTABLE;INJECTION

ACTHREL

+ FERRING

EQ 0.1MG BASE/VIAL

N020162 001 May 23, 1996

CORTICOTROPIN

INJECTABLE;INJECTION

H.P. ACTHAR GEL

+ MALLINCKRODT ARD

80 UNITS/ML

N008372 008

CORTISONE ACETATE

TABLET;ORAL

CORTISONE ACETATE

+ HIKMA INTL PHARMS

25MG

A080776 002

0.25MG/VIAL

N016750 001

0.25MG/VIAL
0.25MG/VIAL

A090574 001 Dec 17, 2009

A202147 001 Jun 29, 2012

200MG
250MG

N202570 001 Aug 26, 2011

N202570 002 Aug 26, 2011

CROFELEMER

TABLET, DELAYED RELEASE;ORAL

FULYZAQ

+ SALIX PHARMS
125MG

N202292 001 Dec 31, 2012

COSYNTROPIN

INJECTABLE;INJECTION

CORTROSYN

AP
+ AMPHASTAR PHARMS INC
COSYNTROPIN

AP
MYLAN INSTITUTIONAL
AP
SANDOZ
CRIZOTINIB

CAPSULE;ORAL

XALKORI

PF PRISM CV
+

CROMOLYN SODIUM

CONCENTRATE;ORAL

CROMOLYN SODIUM

AA
MICRO LABS LTD INDIA
AA
PACK PHARMS LLC
GASTROCROM

AA
+ MEDA PHARMS
SOLUTION;INHALATION

CROMOLYN SODIUM

AN
BAUSCH AND LOMB
AN
MYLAN SPECLT
AN
+ TEVA PHARMS
AN
WOCKHARDT
SOLUTION/DROPS;OPHTHALMIC

CROLOM

AT
BAUSCH AND LOMB
CROMOLYN SODIUM

AT
+ AKORN
AT
ALCON

100MG/5ML
100MG/5ML

A202745 001 Apr 04, 2013

A202583 001 Oct 27, 2011

100MG/5ML

N020479 001 Feb 29, 1996

10MG/ML
10MG/ML
10MG/ML
10MG/ML

A075585
A074209
A075271
A075346

4%

A074443 001 Jan 30, 1995

4%
4%

A074706 001 Apr 29, 1998

A075282 001 Jun 16, 1999

001
001
001
001

Dec
Apr
Jan
Oct

21,
26,
18,
25,

2000

1994

2000

1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-97(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CROTAMITON

CREAM;TOPICAL

EURAX

+ RANBAXY
LOTION;TOPICAL

CROTAN

AT
SUMMERS
EURAX

AT
+ RANBAXY

10%

N006927 001

10%

A087204 001

10%

N009112 003

CUPRIC CHLORIDE

INJECTABLE;INJECTION

CUPRIC CHLORIDE IN PLASTIC CONTAINER

+ HOSPIRA
EQ 0.4MG COPPER/ML
CYANOCOBALAMIN

INJECTABLE;INJECTION

CYANOCOBALAMIN

AP
GAVIS PHARMS LLC
AP
+ LUITPOLD
VIBISONE

AP
+ FRESENIUS KABI USA
SPRAY, METERED;NASAL

NASCOBAL

+ PAR PHARM

N018960 001 Jun 26, 1986

1MG/ML
1MG/ML

A206503 001 Dec 11, 2015

A080737 001

1MG/ML

A080557 003

0.5MG/SPRAY

N021642 001 Jan 31, 2005

CYCLOBENZAPRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

AMRIX

AB
IVAX INTL
15MG
AB
+
30MG
CYCLOBENZAPRINE HYDROCHLORIDE

AB
TWI PHARMS INC
15MG
AB
30MG
TABLET;ORAL

CYCLOBENZAPRINE HYDROCHLORIDE

AB
ACTAVIS LABS FL INC
5MG
AB
7.5MG
AB
10MG
AB
AUROBINDO PHARMA
5MG
AB
10MG
AB
INVAGEN PHARMS
5MG
AB
10MG
AB
JUBILANT CADISTA
5MG
AB
10MG
AB
KVK TECH
5MG
AB
10MG
AB
MYLAN PHARMS INC
5MG
AB
7.5MG
AB
+
10MG
AB
ORIT LABS LLC
5MG
AB
10MG
AB
PLIVA
10MG
AB
PROSAM LABS
10MG
AB
SUN PHARM INDS
5MG
AB
10MG
AB
SUN PHARM INDS LTD
5MG
AB
7.5MG
AB
10MG
AB
VINTAGE PHARMS
5MG
AB
10MG
CYCLOPENTOLATE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AKPENTOLATE

AT
AKORN
1%
CYCLOGYL

AT
+ ALCON
0.5%
AT
+
1%
CYCLOPENTOLATE HYDROCHLORIDE

AT
AKORN INC
0.5%
PENTOLAIR

AT
BAUSCH AND LOMB
1%

N021777 001 Feb 01, 2007

N021777 002 Feb 01, 2007

A091281 001 Jan 31, 2013

A091281 002 Jan 31, 2013

A071611
A071611
A071611
A078643
A078643
A090478
A090478
A077563
A077563
A078048
A078048
A073144
A073144
A073144
A078218
A078218
A074421
A077209
A073541
A073541
A078722
A078722
A078722
A077797
A077797

002
003
001
001
002
001
002
001
002
001
002
002
003
001
002
001
001
001
002
001
001
002
003
001
002

Feb
Feb
May
Sep
Sep
Jul
Jul
Apr
Apr
Feb
Feb
Feb
Mar
May
Jun
Apr
Sep
Oct
Apr
May
May
May
May
Feb
Feb

03,
03,
03,
26,
26,
23,
23,
19,
19,
28,
28,
03,
25,
30,
19,
18,
29,
04,
06,
23,
12,
12,
12,
28,
28,

2006

2006

1989

2008

2008

2010

2010

2006

2006

2011

2011

2006

2013

1991

2015

2008

1995

2005

2006

1995

2008

2008

2008

2007

2007

A040164 001 Jan 13, 1997

A084109 001

A084110 001

A205937 001 Dec 09, 2015

A040075 001 Apr 29, 1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-98(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CYCLOPENTOLATE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CYCLOGYL

+ ALCON LABS INC

2%

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CYCLOMYDRIL

+ ALCON
0.2%;1%
CYCLOPHOSPHAMIDE

CAPSULE;ORAL

CYCLOPHOSPHAMIDE

ROXANE
+
INJECTABLE;INJECTION

CYCLOPHOSPHAMIDE

AP
+ BAXTER HLTHCARE
AP
+
AP
+
AP
JIANGSU HENGRUI MED
AP
AP
CYTOXAN (LYOPHILIZED)

AP
+ BAXTER HLTHCARE
AP
+
AP
+
TABLET;ORAL

CYCLOPHOSPHAMIDE

ROXANE
+
CYCLOSERINE

CAPSULE;ORAL

SEROMYCIN

+ PURDUE GMP
CYCLOSPORINE

CAPSULE;ORAL

CYCLOSPORINE

AB1
IVAX SUB TEVA PHARMS
AB1
AB1
AB1
SANDOZ
AB1
AB1
WATSON LABS INC
AB1
GENGRAF

AB1
ABBVIE
AB1
AB1
NEORAL

AB1
NOVARTIS
AB1 +
CYCLOSPORINE

AB2
APOTEX
AB2
SANDIMMUNE

AB2
NOVARTIS
AB2 +
BX
EMULSION;OPHTHALMIC

RESTASIS

+ ALLERGAN
INJECTABLE;INJECTION

CYCLOSPORINE

AP
EUROHLTH INTL SARL
AP
LUITPOLD
SANDIMMUNE

AP
+ NOVARTIS
SOLUTION;ORAL

CYCLOSPORINE

AB1
ABBVIE
AB1
IVAX SUB TEVA PHARMS

A084108 001

A084300 001

25MG
50MG

N203856 001 Sep 16, 2013

N203856 002 Sep 16, 2013

500MG/VIAL
1GM/VIAL
2GM/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL

A040745
A040745
A040745
A204555
A204555
A204555

500MG/VIAL
1GM/VIAL
2GM/VIAL

N012142 003

N012142 004 Aug 30, 1982

N012142 005 Aug 30, 1982

25MG
50MG

A040032 001 Aug 17, 1999

A040032 002 Aug 17, 1999

250MG

A060593 001

25MG
50MG
100MG
25MG
100MG
25MG
100MG

A065110
A065110
A065110
A065017
A065017
A065044
A065044

25MG
50MG
100MG

A065003 001 May 12, 2000

A065003 002 May 12, 2000

A065003 003 May 12, 2000

25MG
100MG

N050715 001 Jul 14, 1995

N050715 002 Jul 14, 1995

25MG
100MG

A065040 001 May 09, 2002

A065040 002 May 09, 2002

25MG
100MG
50MG

N050625 001 Mar 02, 1990

N050625 002 Mar 02, 1990

N050625 003 Nov 23, 1992

0.05%

N050790 001 Dec 23, 2002

50MG/ML
50MG/ML

A065004 001 Oct 29, 1999

A065151 001 Oct 07, 2003

50MG/ML

N050573 001 Nov 14, 1983

100MG/ML
100MG/ML

A065025 001 Mar 03, 2000

A065078 001 Mar 25, 2005

001
002
003
001
002
003

003
001
002
002
001
002
001

May
May
May
Oct
Oct
Oct

Mar
Mar
Mar
Jan
Jan
Dec
Dec

21,
21,
21,
31,
31,
31,

29,
29,
29,
13,
13,
20,
20,

2008

2008

2008

2014

2014

2014

2005

2005

2005

2000

2000

2000

2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-99(of 388)

PRESCRIPTION DRUG PRODUCT LIST

CYCLOSPORINE

SOLUTION;ORAL

CYCLOSPORINE

AB1
WATSON LABS
NEORAL

AB1 + NOVARTIS
CYCLOSPORINE

AB2
WOCKHARDT
SANDIMMUNE

AB2 + NOVARTIS

100MG/ML

A065054 001 Dec 18, 2001

100MG/ML

N050716 001 Jul 14, 1995

100MG/ML

A065133 001 Sep 17, 2004

100MG/ML

N050574 001 Nov 14, 1983

CYPROHEPTADINE HYDROCHLORIDE

SYRUP;ORAL

CYPROHEPTADINE HYDROCHLORIDE

AA
+ LYNE
2MG/5ML
AA
PHARM ASSOC
2MG/5ML
TABLET;ORAL

CYPROHEPTADINE HYDROCHLORIDE

AA
COREPHARMA
4MG
AA
+ IVAX SUB TEVA PHARMS
4MG
AA
MIRROR PHARMS LLC
4MG
AA
PAR PHARM
4MG
AA
STASON PHARMS
4MG
CYSTEAMINE BITARTRATE

CAPSULE;ORAL

CYSTAGON

MYLAN
EQ
+
EQ
CAPSULE, DELAYED RELEASE;ORAL

PROCYSBI

RAPTOR INC
EQ
+
EQ
CYSTEAMINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CYSTARAN

+ SIGMA TAU

A040537
A087056
A205087
A087129
A040644

001 Sep 30, 2003

001

001 Sep 23, 2015

001

001 May 30, 2006

50MG BASE
150MG BASE

N020392 001 Aug 15, 1994

N020392 002 Aug 15, 1994

25MG BASE
75MG BASE

N203389 001 Apr 30, 2013

N203389 002 Apr 30, 2013

EQ 0.44% BASE

CYTARABINE

INJECTABLE;INJECTION

CYTARABINE

AP
EUROHLTH INTL SARL
100MG/VIAL
AP
500MG/VIAL
AP
1GM/VIAL
AP
2GM/VIAL
AP
+ FRESENIUS KABI USA
100MG/ML
AP
+ HOSPIRA
20MG/ML
AP
+
20MG/ML
AP
+
20MG/ML
AP
100MG/ML
AP
MYLAN LABS LTD
20MG/ML
AP
20MG/ML
AP
20MG/ML
AP
100MG/ML
CYTOSAR-U

AP
TEVA PHARMS USA
100MG/VIAL
AP
+
500MG/VIAL
AP
+
1GM/VIAL
AP
+
2GM/VIAL
INJECTABLE, LIPOSOMAL;INJECTION

DEPOCYT

+ PACIRA PHARMS INC
10MG/ML
DABIGATRAN ETEXILATE MESYLATE

CAPSULE;ORAL

PRADAXA

BOEHRINGER INGELHEIM

A040668 001 Jun 28, 2006

A091295 001 Mar 28, 2013

EQ 75MG BASE
EQ 110MG BASE
EQ 150MG BASE

N200740 001 Oct 02, 2012

A071471
A071472
A074245
A074245
A076512
A071868
A072168
A072945
A075383
A200914
A200915
A200916
A201784

001
001
001
002
001
001
001
001
001
001
001
001
001

Aug
Aug
Aug
Aug
Jan
Jun
Aug
Feb
Nov
Dec
Dec
Dec
Jan

02,
02,
31,
31,
15,
04,
31,
28,
22,
13,
13,
13,
30,

1989

1989

1994

1994

2004

1990

1990

1994

1999

2011

2011

2011

2012

A075206
A075206
A075206
A075206

001
002
004
003

Dec
Dec
Dec
Dec

30,
30,
30,
30,

1998

1998

1998

1998

N021041 001 Apr 01, 1999

N022512 001 Oct 19, 2010

N022512 003 Nov 20, 2015

N022512 002 Oct 19, 2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-100(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DABRAFENIB MESYLATE

CAPSULE;ORAL

TAFINLAR

NOVARTIS PHARMS CORP
+

EQ 50MG BASE
EQ 75MG BASE

N202806 001 May 29, 2013

N202806 002 May 29, 2013

DACARBAZINE

INJECTABLE;INJECTION

DACARBAZINE

AP
EUROHLTH INTL SARL
AP
AP
FRESENIUS KABI USA
AP
AP
HOSPIRA
AP
TEVA PHARMS USA
AP
+
DTIC-DOME

AP
+ BAYER HLTHCARE
AP
+

200MG/VIAL
500MG/VIAL
100MG/VIAL
200MG/VIAL
200MG/VIAL
200MG/VIAL
500MG/VIAL

A075812
A075812
A075371
A075371
A075940
A075259
A075259

100MG/VIAL
200MG/VIAL

N017575 001

N017575 002

DACLATASVIR DIHYDROCHLORIDE

TABLET;ORAL

DAKLINZA

BRISTOL-MYERS SQUIBB
+

EQ 30MG BASE
EQ 60MG BASE

N206843 001 Jul 24, 2015

N206843 002 Jul 24, 2015

0.5MG/VIAL

N050682 001

0.5MG/VIAL
0.5MG/VIAL

A090304 001 Mar 16, 2010

A202562 001 Aug 23, 2013

EQ 500MG BASE/VIAL

N021883 001 May 23, 2014

DACTINOMYCIN

INJECTABLE;INJECTION

COSMEGEN

AP
+ RECORDATI RARE
DACTINOMYCIN

AP
EUROHLTH INTL SARL
AP
LUITPOLD
DALBAVANCIN HYDROCHLORIDE

INJECTABLE;IV (INFUSION)

DALVANCE

+ DURATA THERAPS INTL

001
002
001
002
001
002
001

Jun
Oct
Aug
Aug
Oct
Aug
Sep

15,
31,
27,
27,
18,
27,
22,

2001

2002

1999

1999

2001

1998

2000

DALFAMPRIDINE

TABLET, EXTENDED RELEASE;ORAL

AMPYRA

+ ACORDA
10MG

N022250 001 Jan 22, 2010

DALFOPRISTIN; QUINUPRISTIN

INJECTABLE;IV (INFUSION)

SYNERCID

+ KING PHARMS

350MG/VIAL;150MG/VIAL

N050748 001 Sep 21, 1999

2,500IU/0.2ML (12,500IU/ML)
5,000IU/0.2ML (25,000IU/ML)
7,500IU/0.3ML (25,000IU/ML)
10,000IU/ML (10,000IU/ML)
12,500IU/0.5ML (25,000IU/ML)
15,000IU/0.6ML (25,000IU/ML)
18,000IU/0.72ML (25,000IU/ML)
95,000IU/3.8ML (25,000IU/ML)

N020287
N020287
N020287
N020287
N020287
N020287
N020287
N020287

001
003
005
004
009
010
011
006

Dec
Mar
Apr
Jan
May
May
May
Apr

22,
18,
04,
30,
01,
01,
01,
04,

1994

1996

2002

1998

2007

2007

2007

2002

50MG
100MG
200MG
50MG
100MG
200MG

A074582
A074582
A074582
A078214
A078214
A077246

003
002
001
001
002
001

May
May
Aug
Apr
Apr
Sep

29,
29,
09,
19,
19,
28,

1998

1998

1996

2007

2007

2005

DALTEPARIN SODIUM

INJECTABLE;SUBCUTANEOUS

FRAGMIN

PFIZER INC

+
DANAZOL

CAPSULE;ORAL

DANAZOL

AB
BARR
AB
AB
+
AB
LANNETT
AB
AB

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-101(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DANTROLENE SODIUM

CAPSULE;ORAL

DANTRIUM

AB
PAR STERILE PRODUCTS

AB

AB
+

DANTROLENE SODIUM

AB
ELITE LABS INC

AB

AB

AB
IMPAX LABS

AB

AB

FOR SUSPENSION;INTRAVENOUS

RYANODEX

EAGLE PHARMS

INJECTABLE;INJECTION

DANTRIUM

AP
+ PAR STERILE PRODUCTS

REVONTO

AP
US WORLDMEDS

DAPAGLIFLOZIN PROPANEDIOL

TABLET;ORAL

FARXIGA

ASTRAZENECA AB

+

25MG

50MG

100MG

N017443 001

N017443 003

N017443 002

25MG

50MG

100MG

25MG

50MG

100MG

A076686
A076686
A076686
A076856
A076856
A076856

250MG/VIAL

N205579 001 Jul 22, 2014

20MG/VIAL

N018264 001

20MG/VIAL

A078378 001 Jul 24, 2007

EQ 5MG BASE

EQ 10MG BASE

N202293 001 Jan 08, 2014

N202293 002 Jan 08, 2014

DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

XIGDUO XR

ASTRAZENECA AB

EQ 5MG BASE;500MG

EQ 5MG BASE;1GM

EQ 10MG BASE;500MG

+

EQ 10MG BASE;1GM

DAPSONE

GEL;TOPICAL

ACZONE

+ ALLERGAN

TABLET;ORAL

DAPSONE
AB
FERA PHARMS LLC
AB
AB
JACOBUS
AB
+
DAPTOMYCIN

INJECTABLE;IV (INFUSION)

CUBICIN

AP
+ CUBIST

DAPTOMYCIN

AP
HOSPIRA INC

001
002
003
004

Oct
Oct
Oct
Mar
Mar
Mar

Oct
Oct
Oct
Oct

24,
24,
24,
01,
01,
01,

29,
29,
29,
29,

2005

2005

2005

2005

2005

2005

2014

2014

2014

2014

5%

N021794 001 Jul 07, 2005

25MG

100MG

25MG

100MG

A205429
A205429
A086841
A086842

500MG/VIAL

N021572 002 Sep 12, 2003

500MG/VIAL

A202857 001 Sep 12, 2014

DARIFENACIN HYDROBROMIDE

TABLET, EXTENDED RELEASE;ORAL

DARIFENACIN HYDROBROMIDE

AB
ANCHEN PHARMS

EQ
AB

EQ
ENABLEX

AB
WARNER CHILCOTT LLC

EQ
AB
+

EQ
DARUNAVIR ETHANOLATE

SUSPENSION;ORAL

PREZISTA

+ JANSSEN PRODS

TABLET;ORAL

PREZISTA

JANSSEN PRODS

N205649
N205649
N205649
N205649

001
002
003
001
002
003

001 Jan 07, 2016

002 Jan 07, 2016

001

001

7.5MG BASE

15MG BASE

A091190 001 Mar 13, 2015

A091190 002 Mar 13, 2015

7.5MG BASE

15MG BASE

N021513 001 Dec 22, 2004

N021513 002 Dec 22, 2004

EQ 100MG BASE/ML

N202895 001 Dec 16, 2011

EQ
EQ
EQ
EQ

N021976
N021976
N021976
N021976

75MG BASE

150MG BASE

600MG BASE

800MG BASE

004
005
002
006

Dec
Dec
Feb
Nov

18,
18,
25,
09,

2008

2008

2008

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-102(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR

TABLET, TABLET;ORAL

VIEKIRA PAK (COPACKAGED)

+ ABBVIE INC
EQ 250MG BASE,N/A,N/A,N/A;
N/A,12.5MG,75MG,50MG

DASATINIB

TABLET;ORAL

SPRYCEL

BRISTOL MYERS SQUIBB

20MG
50MG
70MG
80MG
100MG
140MG

DAUNORUBICIN CITRATE

INJECTABLE, LIPOSOMAL;INJECTION

DAUNOXOME

+ GALEN (UK)
EQ 2MG BASE/ML
DAUNORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

CERUBIDINE

AP
+ EUROHLTH INTL SARL
DAUNORUBICIN HYDROCHLORIDE

AP
+ EUROHLTH INTL SARL
AP
FRESENIUS KABI USA
AP
TEVA PHARMS USA
FRESENIUS KABI USA
DECITABINE

INJECTABLE;INTRAVENOUS

DACOGEN

AP
+ OTSUKA PHARM CO LTD
DECITABINE

AP
DR REDDYS LABS LTD
AP
SANDOZ INC
POWDER;INTRAVENOUS

DECITABINE

+ SUN PHARMA GLOBAL
DEFERASIROX

TABLET;ORAL

JADENU

NOVARTIS PHARMS CORP
+
TABLET, FOR SUSPENSION;ORAL

EXJADE

NOVARTIS
+
DEFERIPRONE

SOLUTION;ORAL

FERRIPROX

+ APOPHARMA INC
TABLET;ORAL

FERRIPROX

+ APOPHARMA INC
DEFEROXAMINE MESYLATE

INJECTABLE;INJECTION

DEFEROXAMINE MESYLATE

AP
EUROHLTH INTL SARL
AP
AP
FRESENIUS KABI USA
AP
AP
HOSPIRA
AP
DESFERAL

AP
+ NOVARTIS
AP
+

N206619 001 Dec 19, 2014

N021986
N021986
N021986
N021986
N021986
N021986

001
002
003
005
004
006

Jun
Jun
Jun
Oct
May
Oct

28,
28,
28,
28,
30,
28,

2006

2006

2006

2010

2008

2010

N050704 002 Apr 08, 1996

EQ 20MG BASE/VIAL

A064103 001 Feb 03, 1995

EQ
EQ
EQ
EQ

N050731
A065000
A065035
A065034

5MG BASE/ML
20MG BASE/VIAL
5MG BASE/ML
5MG BASE/VIAL

001
001
001
001

Jan
May
Jan
Nov

30,
25,
24,
20,

1998

1999

2000

2001

50MG/VIAL

N021790 001 May 02, 2006

50MG/VIAL
50MG/VIAL

A203131 001 Jul 11, 2013

A202969 001 Aug 28, 2014

50MG/VIAL

N205582 001 Jan 28, 2014

90MG
180MG
360MG

N206910 001 Mar 30, 2015

N206910 002 Mar 30, 2015

N206910 003 Mar 30, 2015

125MG
250MG
500MG

N021882 001 Nov 02, 2005

N021882 002 Nov 02, 2005

N021882 003 Nov 02, 2005

100MG/ML

N208030 001 Sep 09, 2015

500MG

N021825 001 Oct 14, 2011

500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL

A078086
A078086
A078718
A078718
A076019
A076019

500MG/VIAL
2GM/VIAL

N016267 001

N016267 002 May 25, 2000

001
002
001
002
001
002

May
May
Sep
Sep
Mar
Mar

30,
30,
15,
15,
17,
17,

2007

2007

2009

2009

2004

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-103(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DEGARELIX ACETATE

POWDER;SUBCUTANEOUS

FIRMAGON

FERRING
+

EQ 80MG BASE/VIAL

EQ 120MG BASE/VIAL

N022201 001 Dec 24, 2008

N022201 002 Dec 24, 2008

DELAVIRDINE MESYLATE

TABLET;ORAL

RESCRIPTOR

VIIV HLTHCARE
+

100MG

200MG

N020705 001 Apr 04, 1997

N020705 002 Jul 14, 1999

DEMECLOCYCLINE HYDROCHLORIDE

TABLET;ORAL

DEMECLOCYCLINE HYDROCHLORIDE

AB
AMNEAL PHARM
150MG

AB
+
300MG

AB
BARR
150MG

AB
300MG

AB
EPIC PHARMA LLC
150MG

AB
300MG

AB
IMPAX LABS
150MG

AB
300MG

AB
VERSAPHARM
150MG

AB
300MG

A065425
A065425
A065171
A065171
A065447
A065447
A065094
A065094
A065389
A065389

DEOXYCHOLIC ACID

SOLUTION;SUBCUTANEOUS

KYBELLA

+ KYTHERA BIOPHARMS

20MG/2ML (10MG/ML)

N206333 001 Apr 29, 2015

DESFLURANE

LIQUID;INHALATION

SUPRANE

+ BAXTER HLTHCARE

99.9%

N020118 001 Sep 18, 1992

10MG

25MG

50MG

75MG

100MG

150MG

10MG

25MG

50MG

75MG

100MG

150MG

A074430
A071601
A071588
A071602
A071766
A074430
A072099
A072100
A072101
A072102
A072103
A072104

001
001
001
001
001
002
001
001
001
001
001
001

10MG

25MG

50MG

75MG

100MG

150MG

N014399
N014399
N014399
N014399
N014399
N014399

007 Feb 11, 1982

001

003

004

005

006

25MG

50MG

75MG

150MG

A071803
A071803
A071803
A071803

002
003
004
005

15MG/VIAL

N021271 001 Apr 04, 2003

0.5MG/ML

N021300 001 Sep 01, 2004

0.5MG/ML

A202592 001 Jun 30, 2015

DESIPRAMINE HYDROCHLORIDE

TABLET;ORAL

DESIPRAMINE HYDROCHLORIDE

AB
ACTAVIS TOTOWA

AB

AB

AB

AB

AB

AB
SANDOZ

AB

AB

AB

AB

AB

NORPRAMIN

AB
SANOFI AVENTIS US

AB

AB

AB

AB
+

AB

DESIPRAMINE HYDROCHLORIDE

ANI PHARMS INC

DESIRUDIN RECOMBINANT

INJECTABLE;SUBCUTANEOUS

IPRIVASK

+ VALEANT PHARMS NORTH

DESLORATADINE

SOLUTION;ORAL

CLARINEX

AA
+ MERCK SHARP DOHME

DESLORATADINE

AA
TARO PHARM INDS

001
002
001
002
001
002
001
002
001
002

Feb
Feb
Dec
Dec
Aug
Aug
Mar
Mar
Dec
Dec

Feb
Jun
Jun
Oct
Oct
Feb
May
May
May
Jun
Jun
Jun

Dec
Dec
Dec
May

27,
27,
13,
13,
18,
18,
22,
22,
01,
01,

09,
05,
05,
05,
05,
09,
24,
24,
24,
20,
20,
20,

08,
08,
08,
29,

2008

2008

2004

2004

2015

2015

2004

2004

2008

2008

1996

1987

1987

1987

1987

1996

1988

1988

1988

1988

1988

1988

1987

1987

1987

1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-104(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DESLORATADINE

TABLET;ORAL

CLARINEX

AB
+ MERCK SHARP DOHME
5MG
DESLORATADINE

AB
BELCHER PHARMS
5MG
AB
DR REDDYS LABS LTD
5MG
AB
LUPIN PHARMS
5MG
AB
MYLAN PHARMS INC
5MG
AB
ORCHID HLTHCARE
5MG
AB
PERRIGO R AND D
5MG
AB
SANDOZ
5MG
AB
SUN PHARM INDS
5MG
TABLET, ORALLY DISINTEGRATING;ORAL

CLARINEX

AB
MERCK SHARP DOHME
2.5MG
AB
+
5MG
DESLORATADINE

AB
REDDYS
2.5MG
AB
5MG
DESLORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

CLARINEX D 24 HOUR

AB
+ MERCK SHARP DOHME
5MG;240MG
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR

AB
DR REDDYS LABS LTD
5MG;240MG
CLARINEX-D 12 HOUR

+ MERCK SHARP DOHME
2.5MG;120MG
DESMOPRESSIN ACETATE

INJECTABLE;INJECTION

DDAVP

AP
+ FERRING PHARMS INC
0.004MG/ML
DESMOPRESSIN ACETATE

AP
HOSPIRA
0.004MG/ML
AP
SUN PHARM INDS LTD
0.004MG/ML
AP
TEVA PHARMS USA
0.004MG/ML
SOLUTION;NASAL

DDAVP

AB
+ FERRING PHARMS INC
0.01%
DESMOPRESSIN ACETATE

AB
SUN PHARM INDS
0.01%
SPRAY, METERED;NASAL

DDAVP (NEEDS NO REFRIGERATION)

AB
+ FERRING PHARMS INC
0.01MG/SPRAY
DESMOPRESSIN ACETATE

AB
+ BAUSCH AND LOMB
0.01MG/SPRAY
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

AB
APOTEX INC
0.01MG/SPRAY
AB
SUN PHARMA GLOBAL
0.01MG/SPRAY
MINIRIN

AB
+ FERRING
0.01MG/SPRAY
STIMATE (NEEDS NO REFRIGERATION)

+ CSL BEHRING
1.5MG/SPRAY
TABLET;ORAL

DDAVP

AB
FERRING PHARMS INC
0.1MG
AB
+
0.2MG
DESMOPRESSIN ACETATE

AB
ACTAVIS LABS FL INC
0.1MG
AB
0.2MG
AB
APOTEX INC
0.1MG
AB
0.2MG
AB
GLENMARK PHARMS LTD
0.1MG
AB
0.2MG
AB
MYLAN PHARMS INC
0.1MG
AB
0.2MG
AB
TEVA PHARMS
0.1MG
AB
0.2MG
FERRING
0.1MG
+
0.2MG

N021165 001 Dec 21, 2001

A078355
A078365
A078352
A078351
A078357
A078361
A078364
A078359

001
001
001
001
001
001
001
001

Apr
Mar
Oct
Feb
Feb
Dec
Dec
Nov

19,
08,
25,
10,
19,
22,
03,
16,

2012

2011

2010

2012

2010

2011

2010

2010

N021312 002 Jul 14, 2005

N021312 001 Jun 26, 2002

A078367 001 Jul 12, 2010

A078367 002 Jul 12, 2010

N021605 001 Mar 03, 2005

A078366 001 Apr 26, 2011

N021313 001 Feb 01, 2006

N018938 001 Mar 30, 1984

A075220 001 Aug 28, 2000

A091280 001 Jan 25, 2013

A074888 001 Oct 15, 1997

N017922 001

A077212 001 Apr 12, 2012

N017922 003 Aug 07, 1996

A074830 001 Jan 25, 1999

A076703 001 Jan 27, 2005

A078271 001 Dec 23, 2013

N021333 001 Sep 16, 2002

N020355 002 Oct 24, 2007

N019955 001 Sep 06, 1995

N019955 002 Sep 06, 1995

A076470
A076470
A077414
A077414
A201831
A201831
A200653
A200653
A077122
A077122
N021795
N021795

001
002
001
002
001
002
001
002
001
002
001
002

Jul
Jul
Mar
Mar
May
May
Jun
Jun
Jan
Jan
May
May

01,
01,
07,
07,
28,
28,
27,
27,
25,
25,
08,
08,

2005

2005

2006

2006

2015

2015

2014

2014

2006

2006

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-105(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DESOGESTREL; ETHINYL ESTRADIOL

TABLET;ORAL-28

BEKYREE

AB
LUPIN LTD
0.15MG,N/A;0.02MG,0.01MG
CYCLESSA

AB
+ ASPEN GLOBAL INC
0.125MG;0.15MG;0.1MG;0.025MG;0.025MG;0.
025MG

DESOGEN

AB
ORGANON USA INC
0.15MG;0.03MG
DESOGESTREL AND ETHINYL ESTRADIOL

AB
DURAMED PHARMS BARR
0.15MG;0.03MG
AB
JAI PHARMA LTD
0.15MG,N/A;0.02MG,0.01MG
AB
0.15MG;0.03MG
AB
NOVAST LABS LTD
0.15MG;0.03MG
AB
WATSON LABS
0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG
AB
0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.
025MG

AB
0.15MG;0.03MG
EMOQUETTE

AB
VINTAGE PHARMS LLC
0.15MG;0.03MG
ENSKYCE

AB
LUPIN LTD
0.15MG;0.03MG
ISIBLOOM

AB
SANDOZ INC
0.15MG;0.03MG
KARIVA

AB
+ BARR
0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG
KIMIDESS

AB
VINTAGE PHARMS
0.15MG,N/A;0.02MG,0.01MG
ORTHO-CEPT

AB
+ JANSSEN PHARMS
0.15MG;0.03MG
PIMTREA

AB
NOVAST LABS LTD
0.15MG,N/A;0.02MG,0.01MG
VELIVET

AB
DURAMED PHARMS BARR
0.125MG;0.15MG;0.1MG;0.025MG;0.025MG;0.
025MG

VIORELE

AB
GLENMARK GENERICS
0.15MG,N/A;0.02MG,0.01MG
DESONIDE

AEROSOL, FOAM;TOPICAL

VERDESO

+ AQUA PHARMS
CREAM;TOPICAL

DESONIDE

AB
+ PERRIGO NEW YORK
AB
TARO
AB
TEVA PHARMS
DESOWEN

AB
GALDERMA LABS LP
GEL;TOPICAL

DESONATE

+ BAYER HLTHCARE
LOTION;TOPICAL

DESONIDE

AB
FOUGERA PHARMS
AB
TARO
DESOWEN

AB
+ GALDERMA LABS LP
OINTMENT;TOPICAL

DESONIDE

AB
FOUGERA PHARMS
AB
+ PERRIGO NEW YORK
AB
TARO
DESOWEN

AB
GALDERMA LABS LP
DESOXIMETASONE

CREAM;TOPICAL

DESOXIMETASONE

AB
ACTAVIS MID ATLANTIC
AB
FOUGERA PHARMS
AB
PERRIGO NEW YORK
AB
VERSAPHARM INC

A202226 001 Aug 12, 2015

N021090 001 Dec 20, 2000

N020071 002 Dec 10, 1992

A075256
A202296
A202085
A091234
A076916
A077182

002
001
001
001
001
001

Aug
Aug
May
Jul
Dec
Jan

12,
30,
20,
12,
29,
24,

1999

2013

2015

2013

2008

2006

A076915 001 Jul 29, 2005

A076675 001 Feb 25, 2011

A201887 001 Mar 07, 2013

A202789 001 Aug 12, 2015

A075863 001 Apr 05, 2002

A076681 001 Apr 30, 2015

N020301 002 Dec 14, 1992

A091247 001 Aug 01, 2013

A076455 001 Feb 24, 2004

A091346 001 Apr 02, 2012

0.05%

N021978 001 Sep 19, 2006

0.05%
0.05%
0.05%

N017010 001

A073548 001 Jun 30, 1992

A074027 001 Sep 28, 1992

0.05%

N019048 001 Dec 14, 1984

0.05%

N021844 001 Oct 20, 2006

0.05%
0.05%

A075860 001 Mar 19, 2002

A202161 001 Oct 31, 2014

0.05%

A072354 001 Jan 24, 1992

0.05%
0.05%
0.05%

A075751 001 Mar 12, 2001

N017426 001

A074254 001 Aug 03, 1994

0.05%

A071425 001 Jun 15, 1988

0.25%
0.25%
0.25%
0.25%

A205082
A078369
A076510
A203234

001
001
001
001

Sep
Jun
Jul
Jun

04,
29,
01,
12,

2015

2010

2003

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-106(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DESOXIMETASONE

CREAM;TOPICAL

TOPICORT

AB
+ TARO
+
GEL;TOPICAL

DESOXIMETASONE

AB
PERRIGO NEW YORK
AB
VERSAPHARM
TOPICORT

AB
+ TARO
OINTMENT;TOPICAL

DESOXIMETASONE

AB
FOUGERA PHARMS
AB
GLENMARK GENERICS
AB
PERRIGO NEW YORK
AB
VERSAPHARM INC
TOPICORT

AB
+ TARO
+ TARO PHARMS NORTH
SPRAY;TOPICAL

TOPICORT

+ TARO

0.25%
0.05%

A073193 001 Nov 30, 1990

A073210 001 Nov 30, 1990

0.05%
0.05%

A077552 001 Jan 09, 2006

A090727 001 Mar 10, 2011

0.05%

A074904 001 Jul 14, 1998

0.25%
0.25%
0.25%
0.25%

A078657
A202838
A077770
A201005

0.25%
0.05%

A074286 001 Jun 07, 1996

N018594 001 Jan 17, 1985

0.25%

N204141 001 Apr 11, 2013

DESVENLAFAXINE

TABLET, EXTENDED RELEASE;ORAL

DESVENLAFAXINE

BC
+ ALEMBIC PHARMS LTD
50MG
BC
+
100MG
KHEDEZLA

BC
OSMOTICA PHARM CORP
50MG
BC
100MG

N204150 001 Mar 04, 2013

N204150 002 Mar 04, 2013

DESVENLAFAXINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL

DESVENLAFAXINE

+ SUN PHARMA GLOBAL
EQ 50MG BASE
+
EQ 100MG BASE
DESVENLAFAXINE SUCCINATE

TABLET, EXTENDED RELEASE;ORAL

DESVENLAFAXINE SUCCINATE

AB
ALEMBIC PHARMS LTD
EQ
AB
EQ
AB
LUPIN LTD
EQ
AB
EQ
AB
MYLAN PHARMS INC
EQ
AB
EQ
AB
SANDOZ INC
EQ
AB
EQ
PRISTIQ

AB
+ WYETH PHARMS INC
EQ
AB
+
EQ
EQ
DEXAMETHASONE

CONCENTRATE;ORAL

DEXAMETHASONE INTENSOL

+ ROXANE
ELIXIR;ORAL

DEXAMETHASONE

AA
LYNE
AA
+ STI PHARMA LLC
AA
VINTAGE PHARMS
AA
WOCKHARDT EU OPERATN
IMPLANT;INTRAVITREAL

OZURDEX

+ ALLERGAN
SOLUTION;ORAL

DEXAMETHASONE

+ ROXANE
SUSPENSION/DROPS;OPHTHALMIC

MAXIDEX

+ ALCON

001
001
001
001

Sep
Sep
Apr
Apr

28,
20,
20,
24,

2012

2013

2015

2014

N204683 001 Jul 10, 2013

N204683 002 Jul 10, 2013

N205583 001 Jan 28, 2014

N205583 002 Jan 28, 2014

50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE

A204003
A204003
A204172
A204172
A204095
A204095
A204028
A204028

001
002
001
002
001
002
001
002

50MG BASE
100MG BASE
25MG BASE

N021992 001 Feb 29, 2008

N021992 002 Feb 29, 2008

N021992 003 Aug 20, 2014

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

29,
29,
29,
29,
29,
29,
29,
29,

2015

2015

2015

2015

2015

2015

2015

2015

1MG/ML

A088252 001 Sep 01, 1983

0.5MG/5ML
0.5MG/5ML
0.5MG/5ML
0.5MG/5ML

A090891
A084754
A091188
A088254

0.7MG

N022315 001 Jun 17, 2009

0.5MG/5ML

A088248 001 Sep 01, 1983

0.1%

N013422 001

001 Jul 12, 2011

001

001 May 11, 2011

001 Jul 27, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-107(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DEXAMETHASONE

TABLET;ORAL

DEXAMETHASONE

AB
ECR
AB
ROXANE
BP
PAR PHARM
BP
BP
BP
BP
+
BP
ROXANE
BP
BP
BP
BP
BP
+

1.5MG
1.5MG
0.5MG
0.75MG
1.5MG
4MG
6MG
0.5MG
0.75MG
1MG
2MG
4MG
6MG

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

DEXAMETHASONE SODIUM PHOSPHATE

AP
AUROBINDO PHARMA LTD
EQ 4MG PHOSPHATE/ML
AP
BD RX
EQ 4MG PHOSPHATE/ML
AP
+ EUROHLTH INTL SARL
EQ 10MG PHOSPHATE/ML
AP
FRESENIUS KABI USA
EQ 4MG PHOSPHATE/ML
AP
+
EQ 10MG PHOSPHATE/ML
AP
+
EQ 10MG PHOSPHATE/ML
AP
+ LUITPOLD
EQ 4MG PHOSPHATE/ML
AP
MYLAN LABS LTD
EQ 4MG PHOSPHATE/ML
AP
EQ 10MG PHOSPHATE/ML
SOLUTION/DROPS;OPHTHALMIC, OTIC

DEXAMETHASONE SODIUM PHOSPHATE

AT
+ ALCON PHARMS LTD
EQ 0.1% PHOSPHATE
AT
BAUSCH AND LOMB
EQ 0.1% PHOSPHATE
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

MAXITROL

AT
+ ALCON LABS INC
0.1%;EQ 3.5MG BASE/GM;10,000
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

AT
BAUSCH AND LOMB
0.1%;EQ 3.5MG BASE/GM;10,000
AT
PERRIGO CO TENNESSEE
0.1%;EQ 3.5MG BASE/GM;10,000
SUSPENSION/DROPS;OPHTHALMIC

DEXASPORIN

AT
BAUSCH AND LOMB
0.1%;EQ 3.5MG BASE/ML;10,000
MAXITROL

AT
ALCON
0.1%;EQ 3.5MG BASE/ML;10,000
AT
+ ALCON LABS INC
0.1%;EQ 3.5MG BASE/ML;10,000

A040700
A084610
A088148
A088160
A088237
A088238
A088481
A084611
A084613
A088306
A087916
A084612
A088316

001
001

001
001
001
001
001
001

001

001
001
001

001

Aug 15, 2008

A206781
A203129
A087702
A084916
A040491
A040572
A087440
A040803
A040802

001
001
001
001

001
001
001
001
001

Dec 01, 2015

Sep 30, 2015

Sep 07, 1982

Apr
Apr
Apr
Apr
Nov

28,
28,
28,
28,
28,

1983

1983

1983

1983

1983

Sep 15, 1983

Aug 26, 1982

Sep 15, 1983

Apr
Apr
Jul
Aug
Aug

11,
22,
21,
29,
29,

2003

2005

1982

2008

2008

A088771 001 Jan 16, 1985

A040069 001 Jul 26, 1996

UNITS/GM

N050065 002

UNITS/GM
UNITS/GM

A064063 001 Jul 25, 1994

A062938 001 Jul 31, 1989

UNITS/ML

A064135 001 Sep 13, 1995

UNITS/ML
UNITS/ML

A062341 001 May 22, 1984

N050023 002

DEXAMETHASONE; TOBRAMYCIN

OINTMENT;OPHTHALMIC

TOBRADEX

+ ALCON
0.1%;0.3%
SUSPENSION/DROPS;OPHTHALMIC

TOBRADEX

AB
+ ALCON
0.1%;0.3%
TOBRAMYCIN AND DEXAMETHASONE

AB
BAUSCH AND LOMB
0.1%;0.3%
TOBRADEX ST

+ ALCON PHARMS LTD
0.05%;0.3%

N050818 001 Feb 13, 2009

DEXCHLORPHENIRAMINE MALEATE

SYRUP;ORAL

DEXCHLORPHENIRAMINE MALEATE

+ WOCKHARDT
2MG/5ML

A088251 001 Mar 23, 1984

DEXLANSOPRAZOLE

CAPSULE, DELAYED RELEASE;ORAL

DEXILANT

TAKEDA PHARMS USA
30MG
+
60MG

N022287 001 Jan 30, 2009

N022287 002 Jan 30, 2009

N050616 001 Sep 28, 1988

N050592 001 Aug 18, 1988

A064134 001 Oct 27, 1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-108(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DEXMEDETOMIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

DEXMEDETOMIDINE HYDROCHLORIDE

AP
AKORN INC
EQ
AP
FRESENIUS KABI USA
EQ
AP
MYLAN INSTITUTIONAL
EQ
AP
PAR STERILE PRODUCTS
EQ
AP
SUN PHARM INDS INC
EQ
PRECEDEX

AP
+ HOSPIRA
EQ
EQ
+
EQ
+
EQ
SOLUTION;IV (INFUSION)

DEXMEDETOMIDINE HYDROCHLORIDE

+ HQ SPCLT PHARMA
EQ
EQ

200MCG
200MCG
200MCG
200MCG
200MCG

BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)

A202585
A201072
A202881
A203972
A202126

001
001
001
001
001

Nov
Sep
Aug
Aug
Aug

24,
18,
18,
18,
20,

2014

2015

2014

2014

2015

200MCG BASE/2ML (EQ 100MCG BASE/ML)

80MCG BASE/20ML (EQ 4MCG BASE/ML)
200MCG BASE/50ML (EQ 4MCG BASE/ML)
400MCG BASE/100ML (EQ 4MCG BASE/ML)

N021038
N021038
N021038
N021038

001
004
002
003

Dec
Nov
Mar
Mar

17,
14,
13,
13,

1999

2014

2013

2013

1MG BASE/10ML (EQ 100MCG BASE/ML)

400MCG BASE/4ML (EQ 100MCG BASE/ML)

N206628 002 Oct 21, 2015

N206628 001 Oct 21, 2015

DEXMETHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDE

AB
INTELLIPHARMACEUTICS
15MG
AB
30MG
AB
MYLAN PHARMS INC
5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
AB
TEVA PHARMS USA
5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
AB
WATSON LABS INC
5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
FOCALIN XR

AB
NOVARTIS
5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
+
40MG
25MG
35MG
TABLET;ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDE

AB
ABHAI INC
2.5MG
AB
5MG
AB
10MG
AB
NOVEL LABS INC
2.5MG
AB
5MG
AB
10MG
AB
SUN PHARM INDS LTD
2.5MG
AB
5MG
AB
10MG
AB
TEVA PHARMS
2.5MG
AB
5MG
AB
10MG
FOCALIN

AB
NOVARTIS
2.5MG
AB
5MG
+
10MG
AB

BASE/2ML
BASE/2ML
BASE/2ML
BASE/2ML
BASE/2ML

(EQ
(EQ
(EQ
(EQ
(EQ

100MCG
100MCG
100MCG
100MCG
100MCG

A078992
A078992
A204266
A204266
A204266
A204266
A202580
A204266
A078908
A078908
A078908
A078908
A202731
A202731
A079108
A079108
A079108
A079108
A079108

003
004
001
002
003
004
001
007
001
002
004
003
003
002
001
002
003
004
005

Nov
Nov
Aug
Aug
Aug
Dec
Aug
Aug
Nov
Nov
May
Nov
May
Nov
Aug
Aug
May
Dec
Nov

18,
18,
25,
25,
25,
21,
28,
25,
19,
19,
19,
19,
19,
19,
05,
05,
19,
21,
21,

2013

2013

2015

2015

2015

2015

2013

2015

2013

2013

2014

2013

2014

2013

2015

2015

2014

2015

2013

N021802
N021802
N021802
N021802
N021802
N021802
N021802
N021802

001
002
004
003
005
006
008
007

May
May
Aug
May
Oct
Aug
Apr
Apr

26,
26,
01,
26,
23,
11,
21,
21,

2005

2005

2006

2005

2009

2010

2011

2011

A206931
A206931
A206931
A204534
A204534
A204534
A201231
A201231
A201231
A077107
A077107
A077107

001
002
003
001
002
003
001
002
003
003
001
002

Dec
Dec
Dec
Dec
Dec
Dec
Sep
Sep
Sep
Jan
Jan
Jan

04,
04,
04,
04,
04,
04,
24,
24,
24,
29,
29,
29,

2015

2015

2015

2015

2015

2015

2015

2015

2015

2007

2007

2007

N021278 001 Nov 13, 2001

N021278 002 Nov 13, 2001

N021278 003 Nov 13, 2001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-109(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DEXRAZOXANE HYDROCHLORIDE

INJECTABLE;INJECTION

DEXRAZOXANE HYDROCHLORIDE

AP
EUROHLTH INTL SARL
AP
AP
MYLAN INSTITUTIONAL
AP
ZINECARD

AP
+ PHARMACIA AND UPJOHN
AP
+
TOTECT

+ BIOCODEX INC

EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

A076068
A076068
A200752
A200752

001
002
001
002

Sep
Sep
Oct
Oct

28,
28,
19,
19,

2004

2004

2011

2011

EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL

N020212 001 May 26, 1995

N020212 002 May 26, 1995

EQ 500MG BASE/VIAL

N022025 001 Sep 06, 2007

DEXTROAMPHETAMINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

DEXEDRINE

AB
AMEDRA PHARMS
5MG
AB
10MG
AB
+
15MG
DEXTROAMPHETAMINE SULFATE

AB
ACTAVIS ELIZABETH
5MG
AB
10MG
AB
15MG
AB
BARR
5MG
AB
10MG
AB
15MG
AB
MALLINCKRODT
5MG
AB
10MG
AB
15MG
SOLUTION;ORAL

DEXTROAMPHETAMINE SULFATE

AA
+ OUTLOOK PHARMS
5MG/5ML
AA
TRIS PHARMA INC
5MG/5ML
TABLET;ORAL

DEXTROAMPHETAMINE SULFATE

AA
AUROLIFE PHARMA LLC
5MG
AA
10MG
AA
AVANTHI INC
5MG
AA
10MG
AA
BARR
5MG
AA
+
10MG
AA
COREPHARMA
5MG
AA
10MG
AA
MALLINCKRODT
5MG
AA
10MG
AA
MIKART
5MG
AA
10MG
2.5MG
7.5MG
15MG
20MG
30MG

N017078 001

N017078 002

N017078 003

A203901
A203901
A203901
A076137
A076137
A076137
A076353
A076353
A076353

001
002
003
001
002
003
001
002
003

Nov
Nov
Nov
Jan
Jan
Jan
May
May
May

30,
30,
30,
18,
18,
18,
06,
06,
06,

2012

2012

2012

2002

2002

2002

2003

2003

2003

A040776 001 Jan 29, 2008

A203644 001 May 29, 2013

A202893
A202893
A203548
A203548
A040361
A040361
A090652
A090652
A040436
A040436
A090533
A090533
A090533
A090533
A090533
A090533
A090533

001
002
001
002
001
002
001
002
001
002
002
004
001
003
005
006
007

Jul
Jul
Nov
Nov
Jan
Jan
Mar
Mar
Jan
Jan
Oct
Oct
Oct
Oct
Oct
Oct
Oct

31,
31,
23,
23,
31,
31,
07,
07,
29,
29,
25,
25,
25,
25,
25,
25,
25,

2013

2013

2015

2015

2001

2001

2014

2014

2002

2002

2011

2011

2011

2011

2011

2011

2011

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETH W/ DEXTROMETHORPHAN

AA
G AND W LABS INC
15MG/5ML;6.25MG/5ML
PROMETHAZINE DM

AA
+ VINTAGE
15MG/5ML;6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

AA
HI TECH PHARMA
15MG/5ML;6.25MG/5ML
PROMETHAZINE W/ DEXTROMETHORPHAN

AA
WOCKHARDT
15MG/5ML;6.25MG/5ML

A088864 001 Jan 04, 1985

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

CAPSULE;ORAL

NUEDEXTA

+ AVANIR PHARMS
20MG;10MG

N021879 001 Oct 29, 2010

A088762 001 Oct 31, 1984

A040649 001 Feb 14, 2006

A040027 001 Jul 31, 1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-110(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE

INJECTABLE;INJECTION

DEXTROSE 10% IN PLASTIC CONTAINER

AP
+ B BRAUN
10GM/100ML
AP
+ BAXTER HLTHCARE
10GM/100ML
AP
+ HOSPIRA
10GM/100ML
DEXTROSE 20% IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
20GM/100ML
AP
+ HOSPIRA
20GM/100ML
DEXTROSE 30% IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
30GM/100ML
AP
+ HOSPIRA
30GM/100ML
DEXTROSE 40% IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
40GM/100ML
AP
+ HOSPIRA
40GM/100ML
DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ B BRAUN
50MG/ML
AP
+
5GM/100ML
AP
+
5GM/100ML
AP
+ BAXTER HLTHCARE
50MG/ML
AP
+
50MG/ML
AP
+
5GM/100ML
AP
+
5GM/100ML
AP
+ HOSPIRA
50MG/ML
AP
+
50MG/ML
AP
+
5GM/100ML
AP
+
5GM/100ML
DEXTROSE 50% IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
50GM/100ML
AP
+
50GM/100ML
AP
+ HOSPIRA
50GM/100ML
DEXTROSE 60% IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
60GM/100ML
DEXTROSE 70% IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
70GM/100ML
AP
+
70GM/100ML
AP
+ HOSPIRA
70GM/100ML
AP
+
70GM/100ML
DEXTROSE 25%

+ HOSPIRA
250MG/ML
DEXTROSE 50%

HOSPIRA
500MG/ML
DEXTROSE 50% IN PLASTIC CONTAINER

HOSPIRA
500MG/ML

N019626 004 Feb 02, 1988

N016694 001

N018080 001

N017521 004

N018564 001 Mar 23, 1982

N017521 003

N019345 001 Jan 26, 1985

N017521 002

N018562 001 Mar 23, 1982

N016730
N016730
N019626
N016673
N020179
N016673
N020179
N016367
N019222
N019466
N019479

002

001

002
003
002
001

001
002

001
001
001

Feb 02, 1988

Oct 30, 1985

Dec 07, 1992

Dec 07, 1992

Jul 13, 1984

Jul 15, 1985

Sep 17, 1985

N017521 001

N020047 001 Jul 02, 1991

N018563 001 Mar 23, 1982

N017521 005 Mar 26, 1982

N017521
N020047
N018561
N019893

006
003
001
001

Mar
Jul
Mar
Dec

26,
02,
23,
26,

1982

1991

1982

1989

N019445 002 Nov 23, 1998

N019445 003 Sep 03, 2014

N019445 001 Jun 03, 1986

DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5GM/100ML;32MG/100ML;128MG/100ML;234MG/
N017385 001

100ML

DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;21MG/100ML;128MG/100ML;234MG/
100ML

N017610 001

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

INJECTABLE;INJECTION

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;31MG/100ML;130MG/100ML;26MG/1
N019873 001 Jun 10, 1993

00ML;320MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE;

SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

INJECTABLE;INJECTION

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;53MG/100ML;100MG/100ML;100MG/
N019515 001 May 08, 1986

100ML;180MG/100ML;280MG/100ML;16MG/100M

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-111(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE;

SODIUM LACTATE

INJECTABLE;INJECTION

DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER

BAXTER HLTHCARE
5GM/100ML;31MG/100ML;141MG/100ML;20MG/1
N017484 001

00ML;12MG/100ML;260MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE;

SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

INJECTABLE;INJECTION

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;30MG/100ML;141MG/100ML;15MG/1
N019513 001 May 08, 1986

00ML;260MG/100ML;25MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;30MG/100ML;97MG/100ML;220MG/1
N019844 001 Jun 10, 1993

00ML;140MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM

GLUCONATE

INJECTABLE;INJECTION

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;30MG/100ML;37MG/100ML;222MG/1
N017609 001
00ML;526MG/100ML;502MG/100ML
DEXTROSE; POTASSIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;150MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;224MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;300MG/100ML
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;150MG/100ML
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;300MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
AP
HOSPIRA
5GM/100ML;224MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;75MG/100ML
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;149MG/100ML
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;298MG/100ML

N017634 001
N017634 003
N017634 002
N019699 004 Sep 29, 1989
N019699 006 Sep 29, 1989
N018371 003
N017634 004
N018371 001
N018371 002

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;150MG/100ML;130MG/100ML;280MG
N019870 001 Jun 10, 1993

/100ML;91MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ

AP
BAXTER HLTHCARE
5GM/100ML;75MG/100ML;200MG/100ML
N018037 006 Apr
AP
5GM/100ML;150MG/100ML;200MG/100ML
N018037 007 Apr
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)

AP
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;200MG/100ML
N018037 004

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ

AP
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;200MG/100ML
N018037 008 Apr
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)

AP
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;200MG/100ML
N018037 001

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ

AP
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;200MG/100ML
N018037 005 Apr
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ

AP
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;200MG/100ML
N018037 009 Apr
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ

AP
BAXTER HLTHCARE
5GM/100ML;75MG/100ML;200MG/100ML
N018037 002

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)

AP
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;200MG/100ML
N018037 003

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;75MG/100ML;330MG/100ML
N018629 005 Mar
AP
5GM/100ML;150MG/100ML;330MG/100ML
N018629 002 Mar

13, 1982

13, 1982

13, 1982

13, 1982

13, 1982

23, 1982

23, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

3-112(of 388)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;330MG/100ML
N018629 003 Mar 23,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;330MG/100ML
N018629 004 Mar 23,
AP
5GM/100ML;300MG/100ML;330MG/100ML
N018629 006 Mar 23,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;330MG/100ML
N018629 007 Mar 23,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;330MG/100ML
N018629 008 Mar 23,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;75MG/100ML;330MG/100ML
N018629 001 Mar 23,
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;450MG/100ML
N018008 010

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

AP
B BRAUN
5GM/100ML;75MG/100ML;200MG/100ML
N019630 008 Feb 17,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;75MG/100ML;330MG/100ML
N019630 014 Feb 17,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;75MG/100ML;450MG/100ML
N019630 020 Feb 17,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;75MG/100ML;900MG/100ML
N019630 026 Feb 17,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;150MG/100ML;200MG/100ML
N019630 010 Feb 17,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;150MG/100ML;330MG/100ML
N019630 016 Feb 17,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;150MG/100ML;450MG/100ML
N019630 022 Feb 17,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;150MG/100ML;900MG/100ML
N019630 028 Feb 17,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;300MG/100ML;200MG/100ML
N019630 012 Feb 17,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;300MG/100ML;330MG/100ML
N019630 018 Feb 17,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;300MG/100ML;450MG/100ML
N019630 024 Feb 17,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;300MG/100ML;900MG/100ML
N019630 030 Feb 17,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;75MG/100ML;450MG/100ML
N018008 005 Apr 28,
AP
5GM/100ML;150MG/100ML;450MG/100ML
N018008 006 Apr 28,
AP
HOSPIRA
5GM/100ML;74.5MG/100ML;450MG/100ML
N018362 005 Mar 28,
AP
5GM/100ML;74.5MG/100ML;450MG/100ML
N018362 009 Jul 05,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;75MG/100ML;900MG/100ML
N019308 004 Apr 05,
AP
5GM/100ML;150MG/100ML;900MG/100ML
N019308 002 Apr 05,
AP
HOSPIRA
5GM/100ML;74.5MG/100ML;900MG/100ML
N019691 002 Mar 24,
AP
5GM/100ML;149MG/100ML;900MG/100ML
N019691 004 Mar 24,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
HOSPIRA
5GM/100ML;224MG/100ML;450MG/100ML
N018362 006 Mar 28,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
HOSPIRA
5GM/100ML;224MG/100ML;900MG/100ML
N019691 006 Mar 24,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;450MG/100ML
N018008 007 Apr 28,
AP
HOSPIRA
5GM/100ML;149MG/100ML;450MG/100ML
N018362 010 Jul 05,
AP
5GM/100ML;298MG/100ML;450MG/100ML
N018362 007 Mar 28,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;900MG/100ML
N019308 005 Apr 05,
AP
5GM/100ML;300MG/100ML;900MG/100ML
N019308 003 Apr 05,
AP
HOSPIRA
5GM/100ML;149MG/100ML;900MG/100ML
N019691 005 Mar 24,
AP
5GM/100ML;298MG/100ML;900MG/100ML
N019691 008 Mar 24,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;450MG/100ML
N018008 008 Apr 28,
AP
HOSPIRA
5GM/100ML;224MG/100ML;450MG/100ML
N018362 002
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;900MG/100ML
N019308 006 Apr 05,
AP
HOSPIRA
5GM/100ML;224MG/100ML;900MG/100ML
N019691 007 Mar 24,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;450MG/100ML
N018008 009 Apr 28,
AP
HOSPIRA
5GM/100ML;298MG/100ML;450MG/100ML
N018362 003

1982

1982

1982

1982

1982

1982

1988
1988
1988
1988
1988
1988
1988
1988
1988
1988
1988
1988
1982
1982
1988
1983
1985
1985
1988
1988
1988
1988
1982
1983
1988
1985
1985
1988
1988
1982

1985
1988
1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

3-113(of 388)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;900MG/100ML
N019308 007 Apr 05,
AP
HOSPIRA
5GM/100ML;298MG/100ML;900MG/100ML
N019691 009 Mar 24,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;450MG/100ML
N018008 004

AP
HOSPIRA
5GM/100ML;74.5MG/100ML;450MG/100ML
N018362 008 Mar 28,
AP
5GM/100ML;149MG/100ML;450MG/100ML
N018362 004 Mar 28,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;900MG/100ML
N019308 001 Apr 05,
AP
HOSPIRA
5GM/100ML;74.5MG/100ML;900MG/100ML
N019691 001 Mar 24,
AP
5GM/100ML;149MG/100ML;900MG/100ML
N019691 003 Mar 24,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;37MG/100ML;200MG/100ML
N019630 031 Feb 17,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;37MG/100ML;450MG/100ML
N019630 037 Feb 17,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;37MG/100ML;900MG/100ML
N019630 043 Feb 17,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;37MG/100ML;110MG/100ML
N019630 001 Feb 17,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;37MG/100ML;200MG/100ML
N019630 007 Feb 17,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;37MG/100ML;330MG/100ML
N019630 013 Feb 17,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;37MG/100ML;450MG/100ML
N019630 019 Feb 17,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;37MG/100ML;900MG/100ML
N019630 025 Feb 17,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;75MG/100ML;200MG/100ML
N019630 032 Feb 17,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;75MG/100ML;450MG/100ML
N019630 038 Feb 17,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;75MG/100ML;900MG/100ML
N019630 044 Feb 17,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN
3.3GM/100ML;75MG/100ML;300MG/100ML
N019630 049 May 07,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;75MG/100ML;110MG/100ML
N019630 002 Feb 17,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;110MG/100ML;200MG/100ML
N019630 033 Feb 17,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;110MG/100ML;450MG/100ML
N019630 039 Feb 17,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;110MG/100ML;900MG/100ML
N019630 045 Feb 17,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN
3.3GM/100ML;110MG/100ML;300MG/100ML
N019630 050 May 07,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;110MG/100ML;110MG/100ML
N019630 003 Feb 17,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;110MG/100ML;200MG/100ML
N019630 009 Feb 17,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;110MG/100ML;330MG/100ML
N019630 015 Feb 17,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;110MG/100ML;450MG/100ML
N019630 021 Feb 17,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;110MG/100ML;900MG/100ML
N019630 027 Feb 17,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;150MG/100ML;200MG/100ML
N019630 034 Feb 17,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;150MG/100ML;450MG/100ML
N019630 040 Feb 17,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;150MG/100ML;900MG/100ML
N019630 046 Feb 17,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN
3.3GM/100ML;150MG/100ML;300MG/100ML
N019630 051 May 07,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;150MG/100ML;110MG/100ML
N019630 004 Feb 17,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;220MG/100ML;200MG/100ML
N019630 035 Feb 17,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;220MG/100ML;450MG/100ML
N019630 041 Feb 17,

1985

1988

1988

1988

1985

1988

1988

1988

1988

1988

1988

1988

1988

1988

1988

1988

1988

1988

1992

1988

1988

1988

1988

1992

1988

1988

1988

1988

1988

1988

1988

1988

1992

1988

1988

1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

3-114(of 388)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;220MG/100ML;900MG/100ML
N019630 047 Feb 17,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN
3.3GM/100ML;220MG/100ML;300MG/100ML
N019630 052 May 07,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;220MG/100ML;110MG/100ML
N019630 005 Feb 17,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;220MG/100ML;200MG/100ML
N019630 011 Feb 17,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;220MG/100ML;330MG/100ML
N019630 017 Feb 17,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;220MG/100ML;450MG/100ML
N019630 023 Feb 17,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;220MG/100ML;900MG/100ML
N019630 029 Feb 17,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;300MG/100ML;200MG/100ML
N019630 036 Feb 17,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;300MG/100ML;450MG/100ML
N019630 042 Feb 17,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;300MG/100ML;900MG/100ML
N019630 048 Feb 17,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN
3.3GM/100ML;300MG/100ML;300MG/100ML
N019630 053 May 07,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;300MG/100ML;110MG/100ML
N019630 006 Feb 17,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;74.5MG/100ML;225MG/100ML
N018365 002 Jul 05,
5GM/100ML;149MG/100ML;225MG/100ML
N018365 006 Mar 28,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;74.5MG/100ML;300MG/100ML
N018876 001 Jan 17,
5GM/100ML;149MG/100ML;300MG/100ML
N018876 006 Mar 28,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;224MG/100ML;225MG/100ML
N018365 008 Mar 28,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;224MG/100ML;300MG/100ML
N018876 007 Mar 28,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;149MG/100ML;225MG/100ML
N018365 001

5GM/100ML;298MG/100ML;225MG/100ML
N018365 009 Mar 28,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;298MG/100ML;300MG/100ML
N018876 008 Mar 28,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;149MG/100ML;300MG/100ML
N018876 002 Jan 17,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;224MG/100ML;225MG/100ML
N018365 003 Jul 05,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;224MG/100ML;300MG/100ML
N018876 003 Jan 17,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;298MG/100ML;225MG/100ML
N018365 004 Jul 05,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;298MG/100ML;300MG/100ML
N018876 004 Mar 28,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;74.5MG/100ML;225MG/100ML
N018365 005 Mar 28,
5GM/100ML;149MG/100ML;225MG/100ML
N018365 007 Mar 28,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;74.5MG/100ML;300MG/100ML
N018876 005 Mar 28,
5GM/100ML;149MG/100ML;300MG/100ML
N018876 009 Mar 28,
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
B BRAUN
10GM/100ML;900MG/100ML
AP
BAXTER HLTHCARE
10GM/100ML;900MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
B BRAUN
2.5GM/100ML;450MG/100ML
AP
BAXTER HLTHCARE
2.5GM/100ML;450MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;200MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;330MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
B BRAUN
5GM/100ML;450MG/100ML
AP
HOSPIRA
5GM/100ML;450MG/100ML

1988

1992

1988

1988

1988

1988

1988

1988

1988

1988

1992

1988

1983

1988

1986

1988

1988

1988

1988

1988

1986

1983

1986

1983

1988

1988

1988

1988

1988

N019631 015 Feb 24, 1988

N016696 001
N019631 004 Feb 24, 1988
N016697 001
N019631 007 Feb 24, 1988
N019631 008 Feb 24, 1988
N019631 009 Feb 24, 1988
N017607 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

DEXTROSE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
B BRAUN
5GM/100ML;900MG/100ML
AP
HOSPIRA
5GM/100ML;900MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;200MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;330MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;450MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
BAXTER HLTHCARE
5GM/100ML;900MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;110MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;200MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;330MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;450MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML;110MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML;200MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML;330MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML;900MG/100ML
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN
3.3GM/100ML;300MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;110MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;225MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA

5GM/100ML;300MG/100ML

DIATRIZOATE MEGLUMINE

SOLUTION;URETHRAL

CYSTOGRAFIN

BRACCO

CYSTOGRAFIN DILUTE

BRACCO

N019631 010 Feb 24, 1988

N017585 001

N016689 001

N016687 001

N016683 001

N016678 001

N019631 011 Feb 24, 1988

N019631 012 Feb 24, 1988

N019631 013 Feb 24, 1988

N019631 014 Feb 24, 1988

N019631 001 Feb 24, 1988

N019631 002 Feb 24, 1988

N019631 003 Feb 24, 1988

N019631 005 Feb 24, 1988

N019631 016 Jan 19, 1990

N019631 006 Feb 24, 1988

N017606 001

N017799 001

30%

N010040 018

18%

N010040 022 Nov 09, 1982

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE;INJECTION

MD-76R

AP
+ LIEBEL-FLARSHEIM

66%;10%

RENOGRAFIN-76

AP
+ BRACCO

66%;10%

SOLUTION;ORAL, RECTAL

GASTROGRAFIN

AA
+ BRACCO

66%;10%

MD-GASTROVIEW

AA
LIEBEL-FLARSHEIM

66%;10%

DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE

SOLUTION;INTRAUTERINE

SINOGRAFIN

+ BRACCO

52.7%;26.8%

DIAZEPAM

CONCENTRATE;ORAL

DIAZEPAM

AA
LANNETT HOLDINGS INC

DIAZEPAM INTENSOL

AA
+ ROXANE

GEL;RECTAL

DIASTAT

VALEANT PHARMS NORTH

DIASTAT ACUDIAL

VALEANT PHARMS NORTH

+

3-115(of 388)

N019292 001 Sep 29, 1989

N010040 001

N011245 003

A087388 001

N011324 002

5MG/ML

A204433 001 Apr 14, 2014

5MG/ML

A071415 001 Apr 03, 1987

2.5MG/0.5ML (5MG/ML)

N020648 001 Jul 29, 1997

10MG/2ML (5MG/ML)

20MG/4ML (5MG/ML)

N020648 007 Sep 15, 2005

N020648 006 Sep 15, 2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-116(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DIAZEPAM

INJECTABLE;INJECTION

DIAZEPAM

AP
+ HOSPIRA
AP
SOLUTION;ORAL

DIAZEPAM

+ ROXANE
TABLET;ORAL

DIAZEPAM

AB
BARR
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
WATSON LABS
AB
AB
VALIUM

AB
ROCHE
AB
AB
+

5MG/ML
5MG/ML

A071583 001 Oct 13, 1987

A072079 001 Dec 20, 1988

5MG/5ML

A070928 001 Apr 03, 1987

2MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG

A070152
A070154
A071307
A071321
A071322
A070325
A070325
A070325
A077749
A077749
A077749
A071134
A071135
A071136

2MG
5MG
10MG

N013263 002

N013263 004

N013263 006

DIAZOXIDE

SUSPENSION;ORAL

PROGLYCEM

+ TEVA BRANDED PHARM

50MG/ML

N017453 001

DICHLORPHENAMIDE

TABLET;ORAL

KEVEYIS

TARO

50MG

N011366 002 Aug 07, 2015

DICLOFENAC

CAPSULE;ORAL

ZORVOLEX

IROKO PHARMS LLC
+

18MG
35MG

N204592 001 Oct 18, 2013

N204592 002 Oct 18, 2013

DICLOFENAC EPOLAMINE

PATCH;TOPICAL

FLECTOR

+ INST BIOCHEM

1.3%

N021234 001 Jan 31, 2007

25MG

N022202 001 Jun 16, 2009

50MG

N022165 001 Jun 17, 2009

50MG

N020142 002 Nov 24, 1993

50MG
50MG
50MG
50MG

A076561
A075463
A075229
A075219

3%

A206493 001 Dec 02, 2015

3%

A200936 001 Oct 28, 2013

3%

N021005 001 Oct 16, 2000

DICLOFENAC POTASSIUM

CAPSULE;ORAL

ZIPSOR

+ DEPOMED INC
FOR SOLUTION;ORAL

CAMBIA

+ DEPOMED INC
TABLET;ORAL

CATAFLAM

AB
+ NOVARTIS
DICLOFENAC POTASSIUM

AB
APOTEX
AB
MYLAN
AB
SANDOZ
AB
TEVA
DICLOFENAC SODIUM

GEL;TOPICAL

DICLOFENAC SODIUM

AB
ACTAVIS MID ATLANTIC
DICLOFENAC SODIUM

AB
TOLMAR
SOLARAZE

AB
+ FOUGERA PHARMS

001
001
001
001
001
002
003
001
001
002
003
001
001
001

001
001
001
001

Nov
Nov
Dec
Dec
Dec
Sep
Sep
Sep
Mar
Mar
Mar
Feb
Feb
Feb

Mar
Jul
Nov
Aug

01,
01,
10,
10,
10,
04,
04,
04,
31,
31,
31,
03,
03,
03,

18,
26,
20,
06,

1985

1985

1986

1986

1986

1985

1985

1985

2006

2006

2006

1987

1987

1987

2004

1999

1998

1998

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-117(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DICLOFENAC SODIUM

GEL;TOPICAL

VOLTAREN

+ GLAXOSMITHKLINE CONS
1%
SOLUTION;INTRAVENOUS

DYLOJECT

+ JAVELIN PHARMS INC
37.5MG/ML (37.5MG/ML)
SOLUTION;TOPICAL

DICLOFENAC SODIUM

AT
APOTEX INC
1.5%
AT
IGI LABS INC
1.5%
AT
LUPIN LTD
1.5%
AT
NOVEL LABS INC
1.5%
AT
PADDOCK LLC
1.5%
AT
TARO
1.5%
AT
WATSON LABS INC
1.5%
PENNSAID

AT
+ NUVO RES INC
1.5%
+ HORIZON PHARMA
2%
SOLUTION/DROPS;OPHTHALMIC

DICLOFENAC SODIUM

AT
AKORN
0.1%
AT
ALCON PHARMS LTD
0.1%
AT
ALTAIRE PHARMS INC
0.1%
AT
BAUSCH AND LOMB
0.1%
AT
NEXUS PHARMS
0.1%
VOLTAREN

AT
+ NOVARTIS
0.1%
TABLET, DELAYED RELEASE;ORAL

DICLOFENAC SODIUM

AB
ACTAVIS ELIZABETH
50MG
AB
75MG
AB
CARLSBAD
25MG
AB
50MG
AB
75MG
AB
MYLAN PHARMS INC
50MG
AB
75MG
AB
+ SANDOZ
25MG
AB
+
50MG
AB
+
75MG
AB
UNIQUE PHARM LABS
25MG
AB
50MG
AB
75MG
TABLET, EXTENDED RELEASE;ORAL

DICLOFENAC SODIUM

AB
ACTAVIS ELIZABETH
100MG
AB
DEXCEL LTD
100MG
AB
MYLAN
100MG
AB
VPNA
100MG
VOLTAREN-XR

AB
+ NOVARTIS
100MG

N022122 001 Oct 17, 2007

N022396 001 Dec 23, 2014

A202027
A202769
A204132
A205878
A202393
A203818
A202852

001
001
001
001
001
001
001

May
Jul
Aug
Dec
Nov
Nov
Nov

27,
08,
20,
09,
24,
26,
24,

2014

2015

2015

2015

2014

2014

2014

N020947 001 Nov 04, 2009

N204623 001 Jan 16, 2014

A077845
A078031
A203383
A078792
A078553

001
001
001
001
001

Apr
Feb
Nov
Dec
Dec

17,
06,
16,
28,
28,

2008

2008

2015

2007

2007

N020037 001 Mar 28, 1991

A074514
A074514
A075185
A075185
A075185
A075281
A075281
A074376
A074376
A074394
A090066
A090066
A077863

001
002
002
003
001
002
003
001
002
001
001
002
003

Mar
Mar
Nov
Nov
Nov
Feb
Feb
Sep
Sep
Nov
Dec
Dec
Jun

26,
26,
13,
13,
13,
12,
12,
28,
28,
30,
01,
01,
08,

1996

1996

1998

1998

1998

2002

2002

1995

1995

1995

2010

2010

2007

A075910
A076201
A076152
A075492

001
001
001
001

Jan
Nov
Dec
Feb

07,
06,
13,
11,

2002

2002

2001

2000

N020254 001 Mar 08, 1996

DICLOFENAC SODIUM; MISOPROSTOL

TABLET, DELAYED RELEASE;ORAL

ARTHROTEC

AB
GD SEARLE LLC
50MG;0.2MG
AB
+
75MG;0.2MG
DICLOFENAC SODIUM AND MISOPROSTOL

AB
ACTAVIS LABS FL INC
50MG;0.2MG
AB
75MG;0.2MG
AB
EAGLE PHARMS
50MG;0.2MG
AB
75MG;0.2MG
AB
SANDOZ
50MG;0.2MG
AB
75MG;0.2MG

A201089
A201089
A200540
A200540
A200158
A200158

001
002
001
002
001
002

DICLOXACILLIN SODIUM

CAPSULE;ORAL

DICLOXACILLIN SODIUM

AB
SANDOZ
AB
+
AB
TEVA
AB
SANDOZ

A061454
A061454
A062286
A062286
A061454

001

003

001 Jun 03, 1982

002 Jun 03, 1982

002

EQ
EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG
125MG

BASE
BASE
BASE
BASE
BASE

N020607 001 Dec 24, 1997

N020607 002 Dec 24, 1997

Jul
Jul
Mar
Mar
May
May

09,
09,
14,
14,
09,
09,

2012

2012

2014

2014

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-118(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DICYCLOMINE HYDROCHLORIDE

CAPSULE;ORAL

BENTYL

AB
+ FOREST LABS INC
10MG
DICYCLOMINE HYDROCHLORIDE

AB
LANNETT
10MG
AB
MYLAN
10MG
AB
WATSON LABS
10MG
INJECTABLE;INJECTION

BENTYL

AP
+ FOREST LABS INC
10MG/ML
BENTYL PRESERVATIVE FREE

AP
+ FOREST LABS INC
10MG/ML
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE)

AP
EUROHLTH INTL SARL
10MG/ML
SYRUP;ORAL

BENTYL

AA
+ APTALIS PHARMA US
10MG/5ML
DICYCLOMINE HYDROCHLORIDE

AA
MIKART
10MG/5ML
TABLET;ORAL

BENTYL

AB
+ FOREST LABS INC
20MG
DICYCLOMINE HYDROCHLORIDE

AB
LANNETT
20MG
AB
MYLAN
20MG
AB
WATSON LABS
20MG
DIDANOSINE

CAPSULE, DELAYED REL PELLETS;ORAL

DIDANOSINE

AB
AUROBINDO PHARMA
125MG
AB
200MG
AB
250MG
AB
400MG
AB
BARR
200MG
AB
250MG
AB
400MG
AB
MYLAN PHARMS INC
125MG
AB
200MG
AB
250MG
AB
400MG
VIDEX EC

AB
BRISTOL MYERS SQUIBB
125MG
AB
200MG
AB
250MG
AB
+
400MG
FOR SOLUTION;ORAL

DIDANOSINE

AA
AUROBINDO PHARMA
10MG/ML
VIDEX

AA
+ BRISTOL MYERS SQUIBB
10MG/ML
TABLET, FOR SUSPENSION;ORAL

DIDANOSINE

AUROBINDO
100MG
150MG
+
200MG
DIENOGEST; ESTRADIOL VALERATE

TABLET;ORAL

NATAZIA

+ BAYER HLTHCARE

2MG;3MG;N/A;1MG;2MG;2MG;3MG;N/A

DIETHYLPROPION HYDROCHLORIDE

TABLET;ORAL

DIETHYLPROPION HYDROCHLORIDE

AA
AVANTHI INC
25MG
AA
COREPHARMA
25MG
AA
LANNETT HOLDINGS INC
25MG
TENUATE

AA
+ ACTAVIS LABS UT INC
25MG

N007409 003 Oct 15, 1984

A084285 001

A040319 001 Sep 07, 1999

A085082 001 Jun 19, 1986

N008370 001 Oct 15, 1984

N008370 002 Oct 15, 1984

A040465 001 Jun 30, 2003

N007961 002 Oct 15, 1984

A040169 001 Mar 24, 2005

N007409 001 Oct 15, 1984

A040230 001 Feb 26, 1999

A040317 001 Sep 07, 1999

A085223 001 Jul 30, 1986

A090094
A090094
A090094
A090094
A077167
A077167
A077167
A090788
A090788
A090788
A090788

001
002
003
004
001
002
003
001
002
003
004

Sep
Sep
Sep
Sep
Dec
Dec
Dec
Apr
Apr
Apr
Apr

24,
24,
24,
24,
03,
03,
03,
08,
08,
08,
08,

2008

2008

2008

2008

2004

2004

2004

2010

2010

2010

2010

N021183
N021183
N021183
N021183

001
002
003
004

Oct
Oct
Oct
Oct

31,
31,
31,
31,

2000

2000

2000

2000

A078112 001 Mar 08, 2007

N020156 001 Oct 09, 1991

A077275 001 Aug 14, 2012

A077275 002 Aug 14, 2012

A077275 003 Aug 14, 2012

N022252 001 May 06, 2010

A201212 001 Dec 22, 2010

A040828 001 Nov 05, 2008

A200177 001 Jul 18, 2011

N011722 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-119(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DIETHYLPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

DIETHYLPROPION HYDROCHLORIDE

AB
LANNETT HOLDINGS INC
75MG
TENUATE DOSPAN

AB
+ ACTAVIS LABS UT INC
75MG

A091680 001 Oct 24, 2011

N012546 001

DIFLORASONE DIACETATE

CREAM;TOPICAL

DIFLORASONE DIACETATE

BX
+ FOUGERA PHARMS
BX
+ TARO
OINTMENT;TOPICAL

DIFLORASONE DIACETATE

AB
FOUGERA PHARMS
AB
+ TARO
AB
VERSAPHARM INC

0.05%
0.05%

A076263 001 Dec 20, 2002

A075508 001 Apr 24, 2000

0.05%
0.05%
0.05%

A075374 001 Apr 27, 1999

A075331 001 May 14, 1999

A206572 001 Jul 24, 2015

DIFLUNISAL

TABLET;ORAL

DIFLUNISAL

AB
HERITAGE PHARMA
AB
+ TEVA

500MG
500MG

A202845 001 Mar 08, 2012

A073673 001 Jul 31, 1992

DIFLUPREDNATE

EMULSION;OPHTHALMIC

DUREZOL

+ ALCON PHARMS LTD

0.05%

N022212 001 Jun 23, 2008

0.05MG/ML

N021648 001 Aug 26, 2004

0.25MG/ML
0.25MG/ML

A083391 001

A040481 001 Aug 21, 2003

0.25MG/ML

N009330 002

0.1MG/ML

N009330 004

0.125MG
0.25MG
0.125MG
0.25MG
0.125MG
0.25MG
0.125MG
0.25MG
0.125MG
0.25MG

A077002
A077002
A078556
A078556
A040282
A040282
A076268
A076268
A076363
A076363

002
001
001
002
001
002
001
002
001
002

Oct
Oct
Jul
Jul
Dec
Dec
Jul
Jul
Jan
Jan

30,
30,
20,
20,
23,
23,
26,
26,
31,
31,

2007

2007

2009

2009

1999

1999

2002

2002

2003

2003

0.125MG
0.25MG
0.0625MG
0.1875MG

N020405
N020405
N020405
N020405

002
004
001
003

Sep
Sep
Sep
Sep

30,
30,
30,
30,

1997

1997

1997

1997

1MG/ML

N005929 001

1MG/ML
1MG/ML

A040453 001 Jun 09, 2003

A040475 001 Apr 28, 2003

0.5MG/INH

N020148 001 Dec 08, 1997

DIGOXIN

ELIXIR;ORAL

DIGOXIN

+ ROXANE
INJECTABLE;INJECTION

DIGOXIN

AP
EUROHLTH INTL SARL
AP
SANDOZ
LANOXIN

AP
+ COVIS INJECTABLES
LANOXIN PEDIATRIC

+ COVIS INJECTABLES
TABLET;ORAL

DIGOXIN

AB
HIKMA INTL PHARMS
AB
AB
IMPAX LABS
AB
AB
MYLAN PHARMS INC
AB
AB
STEVENS J
AB
AB
SUN PHARM INDS INC
AB
LANOXIN

AB
CONCORDIA PHARMS INC
AB
+

DIHYDROERGOTAMINE MESYLATE

INJECTABLE;INJECTION

D.H.E. 45

AP
+ VALEANT
DIHYDROERGOTAMINE MESYLATE

AP
BEDFORD LABS
AP
PADDOCK LLC
SPRAY, METERED;NASAL

MIGRANAL

+ VALEANT

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-120(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

DILTIAZEM HYDROCHLORIDE

AB2
ACTAVIS LABS FL INC
120MG
AB2
180MG
AB2
240MG
AB2
APOTEX
120MG
AB2
180MG
AB2
240MG
AB2
MYLAN
120MG
AB2
180MG
AB2 +
240MG
CARDIZEM CD

AB3
VALEANT INTL
120MG
AB3
180MG
AB3
240MG
AB3
300MG
AB3 +
360MG
CARTIA XT

AB3
ACTAVIS LABS FL INC
120MG
AB3
180MG
AB3
240MG
AB3
300MG
DILTIAZEM HYDROCHLORIDE

AB3
ACTAVIS ELIZABETH
360MG
AB3
PAR PHARM
120MG
AB3
180MG
AB3
240MG
AB3
300MG
AB3
SUN PHARMA GLOBAL
120MG
AB3
180MG
AB3
240MG
AB3
300MG
AB3
360MG
AB3
VALEANT INTL
120MG
AB3
180MG
AB3
240MG
AB3
300MG
AB4
SANDOZ
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
AB4
420MG
AB4
SUN PHARMA GLOBAL
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
DILTZAC

AB4
APOTEX INC
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
TAZTIA XT

AB4
ACTAVIS LABS FL INC
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
TIAZAC

AB4
VALEANT PHARMS NORTH
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
AB4 +
420MG
DILTIAZEM HYDROCHLORIDE

BC
+ MYLAN
120MG
60MG
90MG

A074852
A074852
A074852
A074943
A074943
A074943
A075124
A075124
A075124

001
002
003
003
002
001
002
003
001

Oct
Oct
Oct
Dec
Dec
Aug
Mar
Mar
Mar

10,
10,
10,
19,
19,
06,
18,
18,
18,

1997

1997

1997

2000

2000

1998

1998

1998

1998

N020062
N020062
N020062
N020062
N020062

001
002
003
004
005

Aug
Dec
Dec
Dec
Aug

10,
27,
27,
27,
24,

1992

1991

1991

1991

1999

A074752
A074752
A074752
A074752

002
001
003
004

Jul
Jul
Jul
Jul

09,
09,
09,
09,

1998

1998

1998

1998

A202463
A074984
A074984
A074984
A074984
A090492
A090492
A090492
A090492
A090492
A075116
A075116
A075116
A075116
A091022
A091022
A091022
A091022
A091022
A091022
A090421
A090421
A090421
A090421
A090421

001
001
002
003
004
001
002
003
004
005
001
002
003
004
001
002
003
004
005
006
001
002
003
004
005

Dec
Dec
Dec
Dec
Dec
Oct
Oct
Oct
Oct
Oct
Dec
Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep
Nov
Nov
Nov
Nov
Nov

07,
20,
20,
20,
20,
28,
28,
28,
28,
28,
23,
23,
23,
23,
28,
28,
28,
28,
28,
28,
15,
15,
15,
15,
15,

2012

1999

1999

1999

1999

2011

2011

2011

2011

2011

1999

1999

1999

1999

2012

2012

2012

2012

2012

2012

2010

2010

2010

2010

2010

A076395
A076395
A076395
A076395
A076395

001
002
003
004
005

Feb
Feb
Feb
Feb
Feb

01,
01,
01,
01,
01,

2006

2006

2006

2006

2006

A075401
A075401
A075401
A075401
A075401

001
002
003
004
005

Apr
Apr
Apr
Apr
Apr

10,
10,
10,
10,
10,

2003

2003

2003

2003

2003

N020401
N020401
N020401
N020401
N020401
N020401

001
002
003
004
005
006

Sep
Sep
Sep
Sep
Sep
Oct

11,
11,
11,
11,
11,
16,

1995

1995

1995

1995

1995

1998

A074910 003 May 02, 1997

A074910 001 May 02, 1997

A074910 002 May 02, 1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-121(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DILTIAZEM HYDROCHLORIDE

INJECTABLE;INJECTION

DILTIAZEM HYDROCHLORIDE

AP
AKORN INC
5MG/ML
AP
+ BEDFORD
5MG/ML
AP
EUROHLTH INTL SARL
5MG/ML
AP
HIKMA FARMACEUTICA
5MG/ML
AP
HOSPIRA
5MG/ML
AP
INTL MEDICATION
5MG/ML
+ HOSPIRA
100MG/VIAL
+ TEVA PHARMS USA
10MG/ML
TABLET;ORAL

CARDIZEM

AB
VALEANT INTL
30MG
AB
60MG
AB
90MG
AB
+
120MG
DILTIAZEM HYDROCHLORIDE

AB
MYLAN
30MG
AB
60MG
AB
90MG
AB
120MG
AB
TEVA
30MG
AB
60MG
AB
90MG
AB
120MG
TABLET, EXTENDED RELEASE;ORAL

CARDIZEM LA

AB
VALEANT INTL
120MG
AB
180MG
AB
240MG
AB
300MG
AB
360MG
AB
+
420MG
DILTIAZEM HYDROCHLORIDE

AB
ACTAVIS LABS FL INC
120MG
AB
180MG
AB
240MG
AB
300MG
AB
360MG
AB
420MG
DIMENHYDRINATE

INJECTABLE;INJECTION

DIMENHYDRINATE

+ FRESENIUS KABI USA

50MG/ML

A040519 001 Jun 23, 2004

DIMERCAPROL

INJECTABLE;INJECTION

BAL

+ AKORN

10%

N005939 001

DIMETHYL FUMARATE

CAPSULE, DELAYED RELEASE;ORAL

TECFIDERA

BIOGEN IDEC INC
120MG
+
240MG
DIMETHYL SULFOXIDE

SOLUTION;INTRAVESICAL

DIMETHYL SULFOXIDE

AT
MYLAN INSTITUTIONAL
RIMSO-50

AT
+ MYLAN INSTITUTIONAL

A075086
A074617
A078538
A202651
A074941
A075749
A075853
A074894

001
001
001
001
001
001
001
002

Apr
Feb
Dec
Aug
Apr
Nov
Dec
Apr

09,
28,
17,
09,
15,
21,
17,
19,

1998

1996

2008

2012

1998

2001

2002

2002

N018602
N018602
N018602
N018602

001
002
003
004

Nov
Nov
Dec
Dec

05,
05,
08,
08,

1982

1982

1986

1986

A072838
A072838
A072838
A072838
A074185
A074185
A074185
A074185

004
003
002
001
001
002
003
004

Nov
Nov
Nov
Nov
May
May
May
May

05,
05,
05,
05,
31,
31,
31,
31,

1992

1992

1992

1992

1995

1995

1995

1995

N021392
N021392
N021392
N021392
N021392
N021392

001
002
003
004
005
006

Feb
Feb
Feb
Feb
Feb
Feb

06,
06,
06,
06,
06,
06,

2003

2003

2003

2003

2003

2003

A077686
A077686
A077686
A077686
A077686
A077686

006
005
004
003
002
001

Mar
Mar
Mar
Mar
Mar
Mar

15,
15,
15,
15,
15,
15,

2010

2010

2010

2010

2010

2010

N204063 001 Mar 27, 2013

N204063 002 Mar 27, 2013

50%

A076185 001 Nov 29, 2002

50%

N017788 001

DINOPROSTONE

GEL;ENDOCERVICAL

PREPIDIL

+ PHARMACIA AND UPJOHN
0.5MG/3GM
INSERT, EXTENDED RELEASE;VAGINAL

CERVIDIL

+ FERRING CONTROLLED
10MG

N019617 001 Dec 09, 1992

N020411 001 Mar 30, 1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-122(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DINOPROSTONE

SUPPOSITORY;VAGINAL

PROSTIN E2

+ PHARMACIA AND UPJOHN

20MG

N017810 001

DIPHENHYDRAMINE HYDROCHLORIDE

CAPSULE;ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

+ BARR
50MG

ELIXIR;ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

+ PHARM ASSOC
12.5MG/5ML

INJECTABLE;INJECTION

DIPHENHYDRAMINE HYDROCHLORIDE

AP
APP PHARMS
50MG/ML

AP
+ EUROHLTH INTL SARL
50MG/ML

AP
HOSPIRA
50MG/ML

AP
MYLAN INSTITUTIONAL
50MG/ML

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

AP
BD RX

50MG/ML

DIPYRIDAMOLE

INJECTABLE;INJECTION

DIPYRIDAMOLE

AP
+ BEDFORD
AP
EUROHLTH INTL SARL
AP
FRESENIUS KABI USA
TABLET;ORAL

DIPYRIDAMOLE

AB
BARR

AB

AB

AB
IMPAX LABS

AB

AB

AB
LANNETT

AB

AB

AB
MURTY PHARMS

AB

AB

AB
PUREPAC PHARM

AB
ZYDUS PHARMS USA INC

AB

AB

PERSANTINE

AB
BOEHRINGER INGELHEIM

AB

AB
+

A087513 001 Feb 10, 1982

A040466
A080817
A040140
A040498

001 May 28, 2002

002

001 Nov 20, 1998

001 Jul 12, 2005

A091526 001 Mar 26, 2013

5MG/ML

5MG/ML

5MG/ML

A074939 001 Apr 13, 1998

A074521 001 Oct 18, 1996

A074956 001 Sep 30, 1998

25MG

50MG

75MG

25MG

50MG

75MG

25MG

50MG

75MG

25MG

50MG

75MG

25MG

25MG

50MG

75MG

A087184
A087716
A087717
A040782
A040782
A040782
A040898
A040898
A040898
A040733
A040733
A040733
A089425
A040874
A040874
A040874

25MG

50MG

75MG

N012836 003 Dec 22, 1986

N012836 004 Feb 06, 1987

N012836 005 Feb 06, 1987

DISOPYRAMIDE PHOSPHATE

CAPSULE;ORAL

DISOPYRAMIDE PHOSPHATE

AB
TEVA

EQ
AB

EQ
AB
WATSON LABS

EQ
AB

EQ
NORPACE

AB
GD SEARLE LLC

EQ
AB
+

EQ
CAPSULE, EXTENDED RELEASE;ORAL

NORPACE CR

AB
+ GD SEARLE LLC

EQ
EQ
DISULFIRAM

TABLET;ORAL

ANTABUSE
AB
ODYSSEY PHARMS
AB
+
DISULFIRAM
AB
MYLAN PHARMS INC
AB
AB
ROXANE

A080738 001

100MG
150MG
100MG
150MG

BASE

BASE

BASE

BASE

A070101
A070102
A070173
A070174

001
001
001
001
002
003
001
002
003
001
002
003
001
001
002
003

001
001
001
001

Oct
Oct
Oct
Jul
Jul
Jul
Apr
Apr
Apr
Feb
Feb
Feb
Jul
Jan
Jan
Jan

Feb
Feb
May
May

03,
03,
03,
18,
18,
18,
23,
23,
23,
13,
13,
13,
12,
28,
28,
28,

22,
22,
31,
31,

1990

1990

1990

2007

2007

2007

2008

2008

2008

2007

2007

2007

1990

2008

2008

2008

1985

1985

1985

1985

100MG BASE

150MG BASE

N017447 001

N017447 002

150MG BASE

100MG BASE

N018655 002 Jul 20, 1982

N018655 001 Jul 20, 1982

250MG

500MG

A088482 001 Dec 08, 1983

A088483 001 Dec 08, 1983

250MG

500MG

250MG

A203916 001 Mar 04, 2015

A203916 002 Mar 04, 2015

A202652 001 Feb 05, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-123(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DISULFIRAM
TABLET;ORAL
DISULFIRAM
AB
AB
SIGMAPHARM LABS LLC
AB
AB
VINTAGE PHARMS
AB
DISULFIRAM
AB
ALVOGEN PINE BROOK

500MG
250MG
500MG
250MG
500MG

A202652
A091619
A091619
A091563
A091563

250MG

A091681 001 Aug 08, 2013

DIVALPROEX SODIUM
CAPSULE, DELAYED REL PELLETS;ORAL

DEPAKOTE

AB
+ ABBVIE

EQ 125MG
DIVALPROEX SODIUM

AB
DR REDDYS LABS LTD

EQ 125MG
AB
MYLAN

EQ 125MG
AB
ZYDUS PHARMS USA INC
EQ 125MG
TABLET, DELAYED RELEASE;ORAL

DEPAKOTE

AB
ABBVIE
EQ 125MG
AB
EQ 250MG
AB
+
EQ 500MG
DIVALPROEX SODIUM
AB
ACTAVIS LABS FL INC
EQ 500MG
AB
ANCHEN PHARMS
EQ 500MG
AB
AUROBINDO PHARMA LTD
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
DR REDDYS LABS LTD
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
LUPIN
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
MYLAN
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
NU PHARM
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
ORCHID HLTHCARE
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
SANDOZ
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
SUN PHARM INDS
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
TEVA
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
UNICHEM LABS LTD
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
UPSHER SMITH
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
VINTAGE
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
WOCKHARDT
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
AB
ZYDUS PHARMS USA INC
EQ 125MG
AB
EQ 250MG
AB
EQ 500MG
TABLET, EXTENDED RELEASE;ORAL

DEPAKOTE ER

AB
ABBVIE

EQ 250MG
AB
+

EQ 500MG

002
001
002
001
002

Feb
Mar
Mar
Dec
Dec

05,
28,
28,
31,
31,

2014

2011

2011

2012

2012

VALPROIC ACID

N019680 001 Sep 12, 1989

VALPROIC ACID

VALPROIC ACID

VALPROIC ACID

A078979 001 Jan 23, 2009

A090407 001 Mar 28, 2011

A078919 001 Jan 27, 2009

VALPROIC ACID

VALPROIC ACID

VALPROIC ACID

N018723 003 Oct 26, 1984

N018723 001 Mar 10, 1983

N018723 002 Mar 10, 1983

VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC

A079080
A078411
A090554
A090554
A090554
A078755
A078755
A078755
A078790
A078790
A078790
A090062
A090062
A090062
A077615
A077615
A077615
A078853
A078853
A078853
A078290
A078290
A078290
A078597
A078597
A078597
A076941
A076941
A076941
A079163
A079163
A079163
A078182
A078182
A078182
A090210
A090210
A090210
A077296
A077296
A077296
A077100
A077100
A077100

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

ACID

VALPROIC ACID

VALPROIC ACID

001
001
001
002
003
001
002
003
001
002
003
001
002
003
003
002
001
001
002
003
003
002
001
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Feb
Nov
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Mar
Mar
Mar
Jul
Jul
Jul
Nov
Nov
Nov
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Apr
Apr
Apr
Jul
Jul
Jul
Nov
Nov
Nov
Jul
Jul
Jul
Mar
Mar
Mar

25,
03,
21,
21,
21,
29,
29,
29,
29,
29,
29,
17,
17,
17,
29,
29,
29,
25,
25,
25,
29,
29,
29,
29,
29,
29,
29,
29,
29,
05,
05,
05,
29,
29,
29,
30,
30,
30,
31,
31,
31,
05,
05,
05,

2011

2008

2011

2011

2011

2008

2008

2008

2008

2008

2008

2009

2009

2009

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2011

2011

2011

2008

2008

2008

2009

2009

2009

2008

2008

2008

2009

2009

2009

N021168 002 May 31, 2002

N021168 001 Aug 04, 2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-124(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DIVALPROEX SODIUM

TABLET, EXTENDED RELEASE;ORAL

DIVALPROEX SODIUM

AB
AMNEAL PHARMS
EQ
AB
EQ
AB
ANCHEN PHARMS
EQ
AB
EQ
AB
AUROBINDO PHARMA LTD
EQ
AB
EQ
AB
DR REDDYS LABS LTD
EQ
AB
IMPAX LABS
EQ
AB
EQ
AB
MYLAN
EQ
AB
EQ
AB
REDDYS
EQ
AB
WOCKHARDT
EQ
AB
EQ
AB
ZYDUS PHARMS USA INC
EQ
AB
EQ
DOBUTAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DOBUTAMINE HYDROCHLORIDE

AP
EUROHLTH INTL SARL
AP
HOSPIRA
AP
+
DOBUTAMINE HYDROCHLORIDE IN
AP
+ BAXTER HLTHCARE
AP
+
AP
+
AP
+
AP
+ HOSPIRA
AP
+
AP
+
AP
+
DOCETAXEL

INJECTABLE;INJECTION

DOCETAXEL

AP
ACCORD HLTHCARE
AP
AP
+
AP
ACTAVIS INC
AP
AP
DR REDDYS LABS LTD
AP
AP
+ HOSPIRA INC
AP
+
AP
+
SANDOZ
AP
AP
AP
AP
TEVA PHARMS USA
AP
TAXOTERE

AP
+ SANOFI AVENTIS US
AP
+
AP
+
DOCEFREZ

+ SUN PHARMA GLOBAL
+
DOCETAXEL

ACCORD HLTHCARE
ACTAVIS INC
PFIZER LABS

SOLUTION;IV (INFUSION)

DOCETAXEL

TEIKOKU PHARMA

250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
250MG
500MG
500MG
250MG
500MG
250MG
500MG

VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC

ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID

A203730
A203730
A078445
A078445
A202419
A202419
A090161
A078791
A078791
A077567
A077567
A090070
A078705
A078705
A078239
A078239

001
002
001
002
001
002
001
001
002
001
002
001
002
001
001
002

May
May
Feb
Aug
Jun
Jun
Mar
May
Aug
Jan
Jan
Mar
Feb
Aug
Feb
Aug

29,
29,
26,
04,
02,
02,
15,
06,
04,
29,
29,
12,
10,
04,
27,
04,

2015

2015

2009

2009

2014

2014

2012

2009

2009

2009

2009

2012

2009

2009

2009

2009

EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
DEXTROSE 5% IN PLASTIC CONTAINER

EQ 50MG BASE/100ML
EQ 100MG BASE/100ML
EQ 200MG BASE/100ML
EQ 400MG BASE/100ML
EQ 50MG BASE/100ML
EQ 100MG BASE/100ML
EQ 200MG BASE/100ML
EQ 400MG BASE/100ML

A074277 001 Oct 31, 1994

A074086 001 Nov 29, 1993

A074292 001 Feb 16, 1995

N020255
N020255
N020255
N020255
N020201
N020201
N020201
N020201

001
003
004
005
003
002
001
006

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jul

19,
19,
19,
19,
19,
19,
19,
07,

1993

1993

1993

1993

1993

1993

1993

1994

20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)
160MG/8ML (20MG/ML)
20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)
20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)
20MG/2ML (10MG/ML)
80MG/8ML (10MG/ML)
160MG/16ML (10MG/ML)
20MG/2ML (10MG/ML)
80MG/8ML (10MG/ML)
160MG/16ML (10MG/ML)
20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)

N201195
N201195
N201195
N203551
N203551
A204193
A204193
N022234
N022234
N022234
N201525
N201525
N201525
A203877
A203877

003
004
005
001
002
001
002
001
002
003
001
002
003
001
002

Apr
Apr
Apr
Apr
Apr
Nov
Nov
Mar
Mar
Mar
Jun
Jun
Jun
Sep
Sep

20,
20,
20,
12,
12,
05,
05,
08,
08,
08,
29,
29,
29,
16,
16,

2012

2012

2012

2013

2013

2014

2014

2011

2011

2011

2011

2011

2011

2015

2015

20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)
160MG/8ML (20MG/ML)

N020449 003 Aug 03, 2010

N020449 004 Aug 02, 2010

N020449 005 Apr 13, 2012

20MG/VIAL
80MG/VIAL

N022534 001 May 03, 2011

N022534 002 May 03, 2011

20MG/0.5ML (40MG/ML)
80MG/2ML (40MG/ML)
140MG/7ML (20MG/ML)
20MG/2ML (10MG/ML)
80MG/8ML (10MG/ML)
130MG/13ML (10MG/ML)
200MG/20ML (10MG/ML)

N201195
N201195
N203551
N202356
N202356
N202356
N202356

20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)

N205934 001 Dec 22, 2015

N205934 002 Dec 22, 2015

001
002
003
001
002
003
004

Jun
Jun
Apr
Mar
Mar
Mar
Mar

08,
08,
12,
13,
13,
13,
13,

2011

2011

2013

2014

2014

2014

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-125(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DOCETAXEL

SOLUTION;IV (INFUSION)

DOCETAXEL

DOFETILIDE

CAPSULE;ORAL

TIKOSYN

PFIZER
+

160MG/8ML (20MG/ML)

N205934 003 Dec 22, 2015

0.125MG
0.25MG
0.5MG

N020931 001 Oct 01, 1999

N020931 002 Oct 01, 1999

N020931 003 Oct 01, 1999

DOLASETRON MESYLATE

INJECTABLE;INJECTION

ANZEMET

+ SANOFI AVENTIS US
+
+
TABLET;ORAL

ANZEMET

SANOFI AVENTIS US
+

12.5MG/0.625ML (20MG/ML)
100MG/5ML (20MG/ML)
500MG/25ML (20MG/ML)

N020624 002 Sep 11, 1997

N020624 001 Sep 11, 1997

N020624 003 Dec 11, 2001

50MG
100MG

N020623 001 Sep 11, 1997

N020623 002 Sep 11, 1997

DOLUTEGRAVIR SODIUM

TABLET;ORAL

TIVICAY

+ VIIV HLTHCARE

EQ 50MG BASE

N204790 001 Aug 12, 2013

5MG
10MG
23MG

N020690 002 Nov 25, 1996

N020690 001 Nov 25, 1996

N022568 001 Jul 23, 2010

23MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
23MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
23MG
5MG
10MG
23MG
5MG
10MG
23MG
23MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG

A202415
A201724
A201724
A078841
A078841
A090056
A090056
A077518
A077518
A202114
A202114
A201001
A201001
A202723
A203034
A203034
A090247
A090247
A201634
A201634
A090768
A090768
A202782
A201146
A201146
A202631
A090521
A090521
A202656
A202542
A090425
A090425
A200292
A200292
A078662
A078662
A090290
A090290
A203907

DONEPEZIL HYDROCHLORIDE

TABLET;ORAL

ARICEPT

AB
EISAI INC
AB
+
AB
+
DONEPEZIL HYDROCHLORIDE

AB
ACTAVIS ELIZABETH
AB
ALEMBIC PHARMS LTD
AB
AB
APOTEX
AB
AB
AUROBINDO
AB
AB
CIPLA LTD
AB
AB
CSPC OUYI PHARM CO
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
HETERO LABS LTD V
AB
AB
HIKMA PHARMS
AB
AB
INDICUS PHARMA
AB
AB
JUBILANT GENERICS
AB
AB
LUPIN LTD
AB
MACLEODS PHARMS LTD
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
PAR PHARM
AB
PLIVA HRVATSKA DOO
AB
AB
PRINSTON INC
AB
AB
ROXANE
AB
AB
SANDOZ
AB
AB
SCIEGEN PHARMS INC

001
001
002
001
002
001
002
001
002
001
002
001
002
001
001
002
001
002
001
002
001
002
001
001
002
001
001
002
001
001
001
002
001
002
001
002
001
002
001

Dec
Feb
Feb
Jun
Jun
May
May
May
May
Jul
Jul
May
May
Jul
Jan
Jan
May
May
Jun
Jun
May
May
Oct
Aug
Aug
Jan
May
May
Oct
Jul
May
May
May
May
May
May
May
May
Oct

17,
25,
25,
02,
02,
31,
31,
31,
31,
05,
05,
31,
31,
24,
30,
30,
31,
31,
13,
13,
31,
31,
30,
17,
17,
22,
31,
31,
22,
24,
31,
31,
31,
31,
31,
31,
31,
31,
29,

2015

2013

2013

2011

2011

2011

2011

2011

2011

2013

2013

2011

2011

2013

2015

2015

2011

2011

2012

2012

2011

2011

2015

2012

2012

2014

2011

2011

2015

2013

2011

2011

2011

2011

2011

2011

2011

2011

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-126(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DONEPEZIL HYDROCHLORIDE

TABLET;ORAL

DONEPEZIL HYDROCHLORIDE

AB
10MG
AB
SUN PHARM INDS
5MG
AB
10MG
AB
SUN PHARM INDS LTD
5MG
AB
10MG
AB
23MG
AB
TEVA
5MG
AB
10MG
AB
TORRENT PHARMS
5MG
AB
10MG
AB
TWI PHARMS INC
23MG
AB
VIVIMED LABS
5MG
AB
10MG
AB
WOCKHARDT
5MG
AB
10MG
AB
ZYDUS PHARMS USA INC
5MG
AB
10MG
TABLET, ORALLY DISINTEGRATING;ORAL

ARICEPT ODT

AB
EISAI INC
5MG
AB
+
10MG
DONEPEZIL HYDROCHLORIDE

AB
BARR
5MG
AB
10MG
AB
MACLEODS PHARMS LTD
5MG
AB
10MG
AB
SANDOZ
5MG
AB
10MG
AB
ZYDUS PHARMS USA INC
5MG
AB
10MG

A078388
A078388
A201787
A201787
A091198
A091198
A090175
A090175

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

NAMZARIC

FOREST LABS LLC
10MG;14MG
+
10MG;28MG

N206439 001 Dec 23, 2014

N206439 002 Dec 23, 2014

DOPAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DOPAMINE HYDROCHLORIDE

AP
+ HOSPIRA
40MG/ML
AP
+
80MG/100ML
AP
+
80MG/ML
AP
+
160MG/100ML
AP
+ LUITPOLD
40MG/ML
AP
+
80MG/ML
AP
+
160MG/ML
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%

AP
+ B BRAUN
80MG/100ML
AP
+
320MG/100ML
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ B BRAUN
160MG/100ML
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
80MG/100ML
AP
+
160MG/100ML
AP
+
320MG/100ML
AP
+ HOSPIRA
80MG/100ML
AP
+
160MG/100ML
AP
+
320MG/100ML
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER

+ B BRAUN
40MG/100ML
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
640MG/100ML
DORIPENEM

INJECTABLE;IV (INFUSION)

DORIBAX

SHIONOGI INC
+

250MG/VIAL
500MG/VIAL

A203907
A090493
A090493
A076786
A076786
A204293
A077344
A077344
A090686
A090686
A203104
A090551
A090551
A091267
A091267
A090100
A090100

002
001
002
001
002
001
001
002
001
002
001
001
002
001
002
001
002

Oct
May
May
Nov
Nov
Jun
May
May
May
May
Oct
May
May
May
May
Oct
Oct

29,
31,
31,
26,
26,
05,
31,
31,
31,
31,
29,
31,
31,
31,
31,
24,
24,

2014

2011

2011

2010

2010

2015

2011

2011

2011

2011

2014

2011

2011

2011

2011

2012

2012

N021720 001 Oct 18, 2004

N021720 002 Oct 18, 2004

N018132
N018132
N018132
N018132
A070799
A070820
A070826

002
001
001
002
001
002
001
002

001

002
004
003
001
001
001

Nov
Nov
Dec
Dec
May
May
May
May

Feb
Jul
Feb
Feb
Feb
Feb

26,
26,
14,
14,
10,
10,
10,
10,

04,
09,
04,
11,
11,
11,

2010

2010

2012

2012

2011

2011

2011

2011

1982

1982

1982

1987

1987

1987

N019099 002 Oct 15, 1986

N019099 004 Oct 15, 1986

N019099 003 Oct 15, 1986

N019615
N019615
N019615
N018826
N018826
N018826

001
002
003
001
002
003

Mar
Mar
Mar
Sep
Sep
Sep

27,
27,
27,
30,
30,
30,

1987

1987

1987

1983

1983

1983

N019099 001 Oct 15, 1986

N019615 004 Mar 27, 1987

N022106 002 Oct 05, 2010

N022106 001 Oct 12, 2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-127(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DORZOLAMIDE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE

AT
ALCON PHARMS LTD
AT
BAUSCH AND LOMB
AT
HI TECH PHARMA
AT
LUITPOLD
AT
SANDOZ
AT
TEVA PHARMS
AT
WATSON LABS INC
AT
ZACH SYSTEMS
TRUSOPT
AT
+ MERCK

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2%
2%
2%
2%
2%
2%
2%
2%

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

EQ 2% BASE

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

COSOPT

AT
+ OAK PHARMS INC
EQ 2% BASE;EQ 0.5%
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

AT
AKORN INC

EQ 2% BASE;EQ 0.5%
AT
ALCON RES

EQ 2% BASE;EQ 0.5%
AT
BAUSCH AND LOMB

EQ 2% BASE;EQ 0.5%
AT
HI TECH PHARMA

EQ 2% BASE;EQ 0.5%
AT
LANNETT HOLDINGS INC
EQ 2% BASE;EQ 0.5%
AT
SANDOZ

EQ 2% BASE;EQ 0.5%
AT
TEVA PHARMS

EQ 2% BASE;EQ 0.5%
AT
WATSON LABS INC

EQ 2% BASE;EQ 0.5%
AT
ZACH SYSTEMS

EQ 2% BASE;EQ 0.5%
COSOPT PF

+ OAK PHARMS INC

EQ 2% BASE;EQ 0.5%
DOXAPRAM HYDROCHLORIDE

INJECTABLE;INJECTION

DOPRAM

AP
+ EUROHLTH INTL SARL

DOXAPRAM HYDROCHLORIDE

AP
BEDFORD

A078981
A090143
A077846
A079186
A078748
A078756
A202053
A091034

001
001
001
001
001
001
001
001

Apr
Jun
Oct
Nov
Nov
Dec
Sep
Dec

13,
25,
28,
18,
06,
04,
11,
04,

2009

2009

2008

2009

2008

2008

2014

2013

N020408 001 Dec 09, 1994

BASE

N020869 001 Apr 07, 1998

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A203058
A090604
A090037
A077847
A201998
A078749
A078704
A202054
A091180

BASE

N202667 001 Feb 01, 2012

001
001
001
001
001
001
001
001
001

Sep
Nov
Jul
Oct
Dec
Nov
Sep
Sep
Dec

22,
18,
14,
28,
17,
06,
28,
03,
04,

2014

2009

2009

2008

2014

2008

2009

2014

2013

20MG/ML

N014879 001

20MG/ML

A076266 001 Jan 10, 2003

DOXAZOSIN MESYLATE

TABLET;ORAL

CARDURA

AB
+ PFIZER

EQ
AB

EQ
AB

EQ
AB

EQ
DOXAZOSIN MESYLATE

AB
ACCORD HLTHCARE

EQ
AB

EQ
AB

EQ
AB

EQ
AB
APOTEX

EQ
AB

EQ
AB

EQ
AB

EQ
AB
DAVA PHARMS INC

EQ
AB

EQ
AB

EQ
AB

EQ
AB
MYLAN

EQ
AB

EQ
AB

EQ
AB

EQ
AB
PLIVA

EQ
AB

EQ
AB

EQ
AB

EQ
AB
TEVA

EQ
AB

EQ
AB

EQ
AB

EQ
TABLET, EXTENDED RELEASE;ORAL

CARDURA XL
PFIZER
EQ
+
EQ

1MG
2MG
4MG
8MG

BASE

BASE

BASE

BASE

N019668
N019668
N019668
N019668

001
002
003
004

Nov
Nov
Nov
Nov

02,
02,
02,
02,

1990

1990

1990

1990

1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A202824
A202824
A202824
A202824
A075580
A075580
A075580
A075580
A076161
A076161
A076161
A076161
A075509
A075509
A075509
A075509
A075750
A075750
A075750
A075750
A075536
A075536
A075536
A075536

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct

11,
11,
11,
11,
18,
18,
18,
18,
10,
10,
10,
10,
19,
19,
19,
19,
08,
08,
08,
08,
18,
18,
18,
18,

2014

2014

2014

2014

2000

2000

2000

2000

2004

2004

2004

2004

2000

2000

2000

2000

2001

2001

2001

2001

2000

2000

2000

2000

4MG BASE
8MG BASE

N021269 001 Feb 22, 2005

N021269 002 Feb 22, 2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-128(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL

DOXEPIN HYDROCHLORIDE

AB
MYLAN PHARMS INC
AB
+
AB
AB
AB
+
+ PAR PHARM
CONCENTRATE;ORAL

DOXEPIN HYDROCHLORIDE

AA
SILARX
AA
+ TEVA PHARMS
AA
WOCKHARDT
CREAM;TOPICAL

ZONALON

+ DELCOR ASSET CORP
TABLET;ORAL

DOXEPIN HYDROCHLORIDE

AB
ACTAVIS ELIZABETH
AB
SILENOR

AB
PERNIX THERAPS LLC
AB
+
DOXERCALCIFEROL

CAPSULE;ORAL

DOXERCALCIFEROL

AB
ROXANE
AB
AB
HECTOROL

AB
GENZYME CORP
AB
AB
+
INJECTABLE;INJECTION

DOXERCALCIFEROL

AP
AKORN INC
AP
HIKMA PHARMS LLC
AP
SANDOZ INC
AP
HECTOROL

AP
+ GENZYME CORP
DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

DOXORUBICIN HYDROCHLORIDE

AP
+ ACTAVIS INC
AP
+
AP
ALVOGEN INC
AP
EUROHLTH INTL SARL
AP
+
AP
+
AP
+
AP
AP
FRESENIUS KABI USA
AP
MYLAN LABS LTD
AP
AP
AP
PHARMACHEMIE BV
AP
AP
AP
AP
AP
PHARMACIA AND UPJOHN
AP
AP
SAGENT PHARMS
AP
SANDOZ INC
AP
SUN PHARM INDS
AP
TEVA PHARMS USA
AP
PHARMACIA AND UPJOHN

EQ
EQ
EQ
EQ
EQ
EQ

10MG BASE
25MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE

A070791
A070791
A070791
A070791
A070791
A071669

002
003
001
004
005
001

May
May
May
May
May
Nov

13,
13,
13,
13,
13,
09,

1986

1986

1986

1986

1986

1987

EQ 10MG BASE/ML
EQ 10MG BASE/ML
EQ 10MG BASE/ML

A074721 001 Dec 29, 1998

A071609 001 Nov 09, 1987

A071918 001 Jul 20, 1988

5%

N020126 001 Apr 01, 1994

EQ 3MG BASE
EQ 6MG BASE

A201951 001 Jul 26, 2013

A201951 002 Jul 26, 2013

EQ 3MG BASE
EQ 6MG BASE

N022036 001 Mar 17, 2010

N022036 002 Mar 17, 2010

0.5MCG
1MCG
2.5MCG

A091433 001 Sep 23, 2011

A091433 002 Jan 14, 2014

A091433 003 Jan 14, 2014

0.5MCG
1MCG
2.5MCG

N020862 002 Apr 23, 2004

N020862 003 Jul 13, 2009

N020862 001 Jun 09, 1999

4MCG/2ML
4MCG/2ML
4MCG/2ML
4MCG/2ML

(2MCG/ML)
(2MCG/ML)
(2MCG/ML)
(2MCG/ML)

A203929
A091101
A091333
A200926

001
001
001
001

May
Aug
May
Feb

07,
30,
05,
04,

2015

2013

2014

2014

4MCG/2ML (2MCG/ML)
2MCG/ML (2MCG/ML)

N021027 001 Apr 06, 2000

N021027 002 Apr 06, 2000

2MG/ML
200MG/100ML
2MG/ML
2MG/ML
10MG/VIAL
20MG/VIAL
50MG/VIAL
200MG/100ML
2MG/ML
2MG/ML
10MG/VIAL
50MG/VIAL
2MG/ML
10MG/VIAL
20MG/VIAL
50MG/VIAL
200MG/100ML
2MG/ML
200MG/100ML
2MG/ML
2MG/ML
2MG/ML
2MG/ML
200MG/100ML
150MG/75ML

A203622
A203622
A065515
A062975
A062921
A062921
A062921
A064097
A063277
A200901
A200170
A200170
A063336
A063097
A063097
A063097
A063336
N050629
N050629
A091495
A200146
A091418
A064140
A064140
N050629

001
002
001
001
001
002
003
001
001
001
001
002
001
001
002
003
004
001
002
001
001
001
001
002
003

Jun
Jun
Nov
Mar
Mar
Mar
Mar
Sep
Oct
Feb
Oct
Oct
Feb
May
May
May
Feb
Dec
May
Mar
Jul
Feb
Jul
Jul
Mar

27,
27,
08,
17,
17,
17,
17,
13,
26,
14,
28,
28,
28,
21,
21,
21,
28,
23,
03,
18,
18,
15,
28,
28,
28,

2014

2014

2012

1989

1989

1989

1989

1994

1995

2012

2011

2011

1995

1990

1990

1990

1995

1987

1988

2013

2012

2012

1995

1995

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-129(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DOXORUBICIN HYDROCHLORIDE

INJECTABLE, LIPOSOMAL;INJECTION

DOXIL (LIPOSOMAL)

AB
JANSSEN RES AND DEV
20MG/10ML (2MG/ML)
AB
50MG/25ML (2MG/ML)
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

AB
+ SUN PHARMA GLOBAL
20MG/10ML (2MG/ML)
AB
+
50MG/25ML (2MG/ML)

N050718 001 Nov 17, 1995

N050718 002 Jun 13, 2000

A203263 001 Feb 04, 2013

A203263 002 Feb 04, 2013

DOXYCYCLINE

CAPSULE;ORAL

DOXYCYCLINE

AB
IMPAX LABS INC
AB
LUPIN LTD
AB
AB
AB
MYLAN PHARMS INC
AB
NOVEL LABS INC
AB
AB
AB
PAR PHARM
AB
AB
+
AB
SUN PHARM INDS LTD
AB
AB
MONODOX

AB
AQUA PHARMS
AB
AB
+
ORACEA

+ GALDERMA LABS LP
FOR SUSPENSION;ORAL

DOXYCYCLINE

AB
CHARTWELL LIFE SCI
AB
LUPIN LTD
VIBRAMYCIN

AB
+ PFIZER
TABLET;ORAL

DOXYCYCLINE

AB
HERITAGE PHARMS INC
AB
AB
AB
AB
LANNETT
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
PAR PHARM
AB
AB
AB
+
AB
SUN PHARM INDS LTD
AB
AB
DOXYCYCLINE CALCIUM

SUSPENSION;ORAL

VIBRAMYCIN

+ PFIZER

EQ 50MG BASE/5ML

N050480 001

DOXYCYCLINE HYCLATE

CAPSULE;ORAL

DOXYCYCLINE HYCLATE

AB
ACTAVIS LABS FL INC
AB
AB
CHARTWELL LIFE SCI
AB
AB
HIKMA INTL PHARMS
AB

EQ
EQ
EQ
EQ
EQ
EQ

A062031
A062031
A062500
A062500
A062396
A062396

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

150MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE

A200065
A204234
A204234
A204234
A202778
A204446
A204446
A204446
A065055
A065055
A065055
A065053
A065053
A065053

001
001
002
003
001
001
002
003
001
002
003
001
003
002

Feb
Mar
Mar
Mar
Jun
May
May
May
Dec
Dec
Jul
Nov
Sep
Nov

17,
05,
05,
05,
08,
28,
28,
28,
01,
01,
15,
22,
10,
22,

2011

2014

2014

2014

2012

2015

2015

2015

2000

2000

2005

2000

2003

2000

EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE

N050641 002 Feb 10, 1992

N050641 003 Oct 18, 2006

N050641 001 Dec 29, 1989

40MG

N050805 001 May 26, 2006

EQ 25MG BASE/5ML
EQ 25MG BASE/5ML

A065454 001 Jul 16, 2008

A201678 001 Mar 18, 2013

EQ 25MG BASE/5ML

N050006 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A091605
A091605
A091605
A091605
A065285
A065285
A065285
A065285
A065377
A065377
A065377
A065427
A065070
A065070
A065070
A065070
A065356
A065356
A065356

50MG BASE
75MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE

50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE

001
002
003
004
001
003
002
004
001
002
003
001
001
003
002
004
001
002
003

002
001

001
002
002
001

Dec
Dec
Dec
Dec
Dec
Jul
Dec
Jul
Nov
Nov
Nov
Jun
Dec
Dec
Dec
Jul
May
May
May

20,
20,
20,
20,
08,
30,
08,
30,
07,
07,
07,
07,
15,
30,
15,
14,
31,
31,
31,

2011

2011

2011

2011

2005

2008

2005

2008

2006

2006

2006

2007

2000

2002

2000

2005

2006

2006

2006

Oct 13, 1982

Sep
Sep
Nov
May

11,
11,
07,
07,

1984

1984

1984

1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-130(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DOXYCYCLINE HYCLATE

CAPSULE;ORAL

DOXYCYCLINE HYCLATE

AB
MUTUAL PHARM
EQ 50MG BASE
AB
EQ 100MG BASE
AB
MYLAN
EQ 50MG BASE
AB
EQ 100MG BASE
VIBRAMYCIN

AB
+ PFIZER
EQ 100MG BASE
DOXYCYCLINE HYCLATE

+ HIKMA INTL PHARMS
EQ 20MG BASE
CAPSULE, DELAYED RELEASE;ORAL

DOXYCYCLINE HYCLATE

MEDICIS
EQ 75MG BASE
+
EQ 100MG BASE
INJECTABLE;INJECTION

DOXY 100

AP
+ FRESENIUS KABI USA
EQ 100MG BASE/VIAL
DOXYCYCLINE

AP
+ EUROHLTH INTL SARL
EQ 100MG BASE/VIAL
AP
MYLAN LABS LTD
EQ 100MG BASE/VIAL
DOXY 200

+ FRESENIUS KABI USA
EQ 200MG BASE/VIAL
SYSTEM, EXTENDED RELEASE;PERIODONTAL

ATRIDOX

+ TOLMAR
50MG
TABLET;ORAL

DOXYCYCLINE HYCLATE

AB
ACTAVIS LABS FL INC
EQ 100MG BASE
AB
BLU CARIBE INC
EQ 100MG BASE
AB
CHARTWELL LIFE SCI
EQ 100MG BASE
AB
COREPHARMA
EQ 20MG BASE
AB
+ HIKMA INTL PHARMS
EQ 100MG BASE
AB
IVAX SUB TEVA PHARMS
EQ 20MG BASE
AB
+ LANNETT
EQ 20MG BASE
AB
LARKEN LABS
EQ 20MG BASE
AB
MUTUAL PHARM
EQ 100MG BASE
AB
MUTUAL PHARMA
EQ 20MG BASE
AB
MYLAN
EQ 100MG BASE
AB
VINTAGE PHARMS
EQ 100MG BASE
ACTICLATE

AQUA PHARMS LLC
EQ 75MG BASE
+
EQ 150MG BASE
TABLET, DELAYED RELEASE;ORAL

DORYX

AB
MAYNE PHARMA
EQ 75MG BASE
AB
EQ 100MG BASE
AB
EQ 150MG BASE
DOXYCYCLINE HYCLATE

AB
ACTAVIS ELIZABETH
EQ 75MG BASE
AB
EQ 100MG BASE
AB
HERITAGE PHARMS INC
EQ 75MG BASE
AB
EQ 100MG BASE
AB
EQ 150MG BASE
AB
IMPAX LABS INC
EQ 75MG BASE
AB
EQ 100MG BASE
AB
MYLAN
EQ 75MG BASE
AB
EQ 100MG BASE
AB
MYLAN PHARMS INC
EQ 150MG BASE
DORYX

MAYNE PHARMA
EQ 80MG BASE
+
EQ 200MG BASE
DOXTERIC

MAYNE PHARMA
EQ 50MG BASE
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

TABLET, DELAYED RELEASE;ORAL

DICLEGIS

+ DUCHESNAY
10MG;10MG

A062675
A062676
A062337
A062337

001
001
001
002

Jul
Jul
Mar
Mar

10,
10,
29,
29,

1986

1986

1982

1982

N050007 002

A065103 001 May 13, 2005

A065281 001 Dec 21, 2005

A065281 002 Dec 21, 2005

A062475 001 Dec 09, 1983

A062569 001 Mar 09, 1988

A091406 001 Aug 21, 2012

A062475 002 Dec 09, 1983

N050751 001 Sep 03, 1998

A062421
A062269
A062505
A065182
A065095
A065163
A065277
A065287
A062677
A065134
A062432
A062538

001
002
001
001
001
001
001
001
001
001
001
001

Feb
Nov
Sep
May
Jul
May
Nov
Feb
Jul
May
Feb
Apr

02,
08,
11,
13,
02,
13,
10,
28,
10,
13,
15,
07,

1983

1982

1984

2005

2003

2005

2005

2006

1986

2005

1983

1986

N205931 001 Jul 25, 2014

N205931 002 Jul 25, 2014

N050795 001 May 06, 2005

N050795 002 May 06, 2005

N050795 003 Jun 20, 2008

A090134
A090134
A200856
A200856
A200856
A090505
A090505
A090431
A090431
A091052

001
002
001
002
003
001
002
001
002
001

Dec
Dec
Apr
Apr
Apr
Dec
Dec
Dec
Dec
Feb

14,
14,
30,
30,
30,
28,
28,
28,
28,
08,

2011

2011

2013

2013

2013

2010

2010

2010

2010

2012

N050795 004 Apr 11, 2013

N050795 005 Apr 11, 2013

N050795 006 Dec 19, 2014

N021876 001 Apr 08, 2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-131(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DRONABINOL

CAPSULE;ORAL

DRONABINOL

AB
AKORN INC

AB

AB

AB
SVC PHARMA

AB

AB

MARINOL

AB
ABBVIE

AB
+

AB

DRONEDARONE HYDROCHLORIDE

TABLET;ORAL

MULTAQ

+ SANOFI AVENTIS US

DROPERIDOL

INJECTABLE;INJECTION

DROPERIDOL

AP
HOSPIRA

AP
LUITPOLD

INAPSINE

AP
+ AKORN INC

DROSPIRENONE; ESTRADIOL

TABLET;ORAL

ANGELIQ

BAYER HLTHCARE

+

2.5MG

5MG

10MG

2.5MG

5MG

10MG

A079217
A079217
A079217
A078292
A078292
A078292

2.5MG

5MG

10MG

N018651 001 May 31, 1985

N018651 002 May 31, 1985

N018651 003 May 31, 1985

EQ 400MG BASE

N022425 001 Jul 01, 2009

2.5MG/ML

2.5MG/ML

A071981 001 Feb 29, 1988

A072123 001 Oct 24, 1988

2.5MG/ML

N016796 001

0.25MG;0.5MG

0.5MG;1MG

N021355 001 Feb 29, 2012

N021355 002 Sep 28, 2005

DROSPIRENONE; ETHINYL ESTRADIOL

TABLET;ORAL

DROSPIRENONE AND ETHINYL ESTRADIOL

AB
BARR

3MG;0.02MG

AB
GLENMARK PHARMS LTD

3MG;0.02MG

AB
JAI PHARMA LTD

3MG;0.02MG

AB
WATSON LABS

3MG;0.02MG

LORYNA

AB
SANDOZ

3MG;0.02MG

NIKKI

AB
LUPIN LTD
3MG;0.02MG

YAZ
AB
+ BAYER HLTHCARE
3MG;0.02MG

TABLET;ORAL-28

DROSPIRENONE AND ETHINYL ESTRADIOL

AB
BARR
3MG;0.03MG

AB
JAI PHARMA LTD
3MG;0.03MG

AB
LUPIN LTD
3MG;0.03MG

AB
WATSON LABS
3MG;0.03MG

SYEDA
AB
SANDOZ
3MG;0.03MG

YAELA
AB
NOVAST LABS LTD
3MG;0.03MG

YASMIN
AB
+ BAYER HLTHCARE
3MG;0.03MG

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

TABLET;ORAL

BEYAZ

BAYER HLTHCARE

3MG,N/A;0.02MG,N/A;0.451MG,0.451MG

SAFYRAL

+ BAYER HLTHCARE

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

DROXIDOPA

CAPSULE;ORAL

NORTHERA

LUNDBECK NA LTD

+

100MG

200MG

300MG

A078515
A204296
A202594
A078833

001
002
003
001
002
003

001
001
001
001

Jun
Jun
Jun
Jun
Jun
Jun

Mar
Aug
Oct
Nov

20,
20,
20,
27,
27,
27,

30,
17,
22,
28,

2014

2014

2014

2008

2008

2008

2009

2015

2015

2011

A079221 001 Mar 28, 2011

A201661 001 May 27, 2014

N021676 001 Mar 16, 2006

A077527
A202131
A201663
A090081

001
001
001
001

May
May
Dec
Sep

09,
04,
18,
07,

2008

2015

2012

2010

A090114 001 Mar 28, 2011

A202015 001 Nov 19, 2014

N021098 001 May 11, 2001

N022532 001 Sep 24, 2010

N022574 001 Dec 16, 2010

N203202 001 Feb 18, 2014

N203202 002 Feb 18, 2014

N203202 003 Feb 18, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-132(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DULOXETINE HYDROCHLORIDE

CAPSULE, DELAYED REL PELLETS;ORAL

CYMBALTA

AB
LILLY

EQ 20MG
AB

EQ 30MG
AB
+

EQ 60MG
DULOXETINE HYDROCHLORIDE

AB
ACTAVIS ELIZABETH

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
ALEMBIC PHARMS LTD

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
ALKEM LABS LTD

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
ANCHEN PHARMS

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
APOTEX INC

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
AUROBINDO PHARMA LTD
EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
BRECKENRIDGE PHARM

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
DR REDDYS LABS LTD

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
INVENTIA HLTHCARE

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
LUPIN LTD

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
SUN PHARMA GLOBAL

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
TEVA PHARMS USA

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
TORRENT PHARMS LTD

EQ 20MG
AB

EQ 30MG
AB

EQ 60MG
AB
ZYDUS PHARMS USA INC
EQ 20MG
AB

EQ 20MG
AB

EQ 30MG
AB

EQ 30MG
AB

EQ 60MG
AB

EQ 60MG
LUPIN LTD

EQ 40MG
DUTASTERIDE

CAPSULE;ORAL

AVODART

AB
+ GLAXOSMITHKLINE

DUTASTERIDE

AB
ACTAVIS LABS FL INC

AB
AMNEAL PHARMS

AB
APOTEX INC

AB
BANNER PHARMACAPS

AB
BARR

AB
BRECKENRIDGE PHARM

AB
RISING PHARMS INC

AB
ROXANE

AB
SANDOZ INC

AB
STRIDES ARCOLAB LTD

AB
VINTAGE PHARMS LLC

BASE

BASE

BASE

N021427 001 Aug 03, 2004

N021427 002 Aug 03, 2004

N021427 004 Aug 03, 2004

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A090776
A090776
A090776
A202949
A202949
A202949
A203197
A203197
A203197
A090780
A090780
A090780
A202045
A202045
A202045
A090778
A090778
A090778
A203088
A203088
A203088
A090723
A090723
A090723
A202336
A202336
A202336
A090694
A090694
A090694
A090745
A090745
A090745
A090783
A090783
A090783
A090774
A090774
A090774
A090728
A090739
A090728
A090739
A090728
A090739
A090694

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
004
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
003

Dec
Dec
Dec
Jun
Jun
Jun
Aug
Aug
Aug
Oct
Oct
Oct
Jun
Jun
Jun
Dec
Dec
Dec
Jun
Jun
Jun
Dec
Dec
Dec
Oct
Oct
Oct
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jan
Jan
Jan
Jan
Jan
Jan
Dec

17,
17,
17,
09,
09,
09,
26,
26,
26,
28,
28,
28,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
28,
28,
28,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
08,
08,
08,
08,
08,
08,
11,

2013

2013

2013

2014

2014

2014

2015

2015

2015

2015

2015

2015

2014

2014

2014

2013

2013

2013

2014

2014

2014

2013

2013

2013

2015

2015

2015

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2014

2014

2014

2014

2014

2014

2013

0.5MG

N021319 001 Nov 20, 2001

0.5MG

0.5MG

0.5MG

0.5MG

0.5MG

0.5MG

0.5MG

0.5MG

0.5MG

0.5MG

0.5MG

A202808
A203118
A204292
A200899
A090095
A204705
A202530
A202204
A202660
A204262
A202421

001
001
001
001
001
001
001
001
001
001
001

Nov
Nov
Nov
Nov
Dec
Nov
Nov
Nov
Nov
Nov
Nov

20,
20,
24,
20,
21,
20,
20,
23,
20,
20,
20,

2015

2015

2015

2015

2010

2015

2015

2015

2015

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-133(of 388)

PRESCRIPTION DRUG PRODUCT LIST

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

AB
ACTAVIS LABS FL INC
0.5MG;0.4MG
AB
ANCHEN PHARMS
0.5MG;0.4MG
JALYN

AB
+ GLAXOSMITHKLINE
0.5MG;0.4MG

N022460 001 Jun 14, 2010

DYPHYLLINE

TABLET;ORAL

LUFYLLIN

MEDA PHARMS
+

200MG
400MG

A084566 001

A084566 002

ECHOTHIOPHATE IODIDE

FOR SOLUTION;OPHTHALMIC

PHOSPHOLINE IODIDE

+ WYETH PHARMS INC

0.125%

N011963 001

1%

N205175 001 Oct 24, 2013

1%
1%
1%
1%

A076075
A076574
A076479
A076005

ECONAZOLE NITRATE

AEROSOL, FOAM;TOPICAL

ECOZA

+ VELDANA MEDICAL SA
CREAM;TOPICAL

ECONAZOLE NITRATE

AB
FOUGERA PHARMS
AB
IGI LABS INC
AB
+ PERRIGO NEW YORK
AB
TARO

EDETATE CALCIUM DISODIUM

INJECTABLE;INJECTION

CALCIUM DISODIUM VERSENATE

+ MEDICIS
200MG/ML
EDOXABAN TOSYLATE

TABLET;ORAL

SAVAYSA

DAIICHI SANKYO
+
EDROPHONIUM CHLORIDE

INJECTABLE;INJECTION

ENLON

+ MYLAN INSTITUTIONAL
EFAVIRENZ

CAPSULE;ORAL

SUSTIVA

BRISTOL MYERS SQUIBB
+
TABLET;ORAL

SUSTIVA

+ BRISTOL MYERS SQUIBB

A202975 001 Nov 20, 2015

A202509 001 Feb 26, 2014

001
001
001
001

Nov
Dec
Jun
Nov

26,
17,
23,
26,

2002

2004

2004

2002

N008922 001

EQ 15MG BASE
EQ 30MG BASE
EQ 60MG BASE

N206316 001 Jan 08, 2015

N206316 002 Jan 08, 2015

N206316 003 Jan 08, 2015

10MG/ML

A088873 001 Aug 06, 1985

50MG
200MG

N020972 001 Sep 17, 1998

N020972 003 Sep 17, 1998

600MG

N021360 002 Feb 01, 2002

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

ATRIPLA

+ GILEAD
600MG;200MG;300MG

N021937 001 Jul 12, 2006

EFINACONAZOLE

SOLUTION;TOPICAL

JUBLIA

+ DOW PHARM

10%

N203567 001 Jun 06, 2014

EFLORNITHINE HYDROCHLORIDE

CREAM;TOPICAL

VANIQA

+ SKINMEDICA

13.9%

N021145 001 Jul 27, 2000

ELETRIPTAN HYDROBROMIDE

TABLET;ORAL

RELPAX

PFIZER IRELAND
+

EQ 20MG BASE
EQ 40MG BASE

N021016 001 Dec 26, 2002

N021016 002 Dec 26, 2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-134(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ELIGLUSTAT TARTRATE

CAPSULE;ORAL

CERDELGA

+ GENZYME CORP

ELTROMBOPAG OLAMINE

FOR SUSPENSION;ORAL

PROMACTA

+ NOVARTIS PHARMS CORP

TABLET;ORAL

PROMACTA

NOVARTIS PHARMS CORP

+

+

EQ 84MG BASE

N205494 001 Aug 19, 2014

EQ 25MG ACID/PACKET

N207027 001 Aug 24, 2015

EQ
EQ
EQ
EQ
EQ

N022291
N022291
N022291
N022291
N022291

12.5MG ACID

25MG ACID

50MG ACID

75MG ACID

100MG ACID

004
001
002
003
005

Oct
Nov
Nov
Sep
Nov

20,
20,
20,
08,
16,

2011

2008

2008

2009

2012

ELUXADOLINE

TABLET;ORAL

VIBERZI

FOREST TOSARA LTD

+

75MG

100MG

N206940 001 May 27, 2015

N206940 002 May 27, 2015

ELVITEGRAVIR

TABLET;ORAL

VITEKTA

GILEAD SCIENCES INC

+

85MG

150MG

N203093 001 Sep 24, 2014

N203093 002 Sep 24, 2014

EMEDASTINE DIFUMARATE

SOLUTION/DROPS;OPHTHALMIC

EMADINE

+ ALCON

0.05%

N020706 001 Dec 29, 1997

EMPAGLIFLOZIN

TABLET;ORAL

JARDIANCE

BOEHRINGER INGELHEIM

+

10MG

25MG

N204629 001 Aug 01, 2014

N204629 002 Aug 01, 2014

EMPAGLIFLOZIN; LINAGLIPTIN

TABLET;ORAL

GLYXAMBI

BOEHRINGER INGELHEIM

+

10MG;5MG

25MG;5MG

N206073 001 Jan 30, 2015

N206073 002 Jan 30, 2015

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

TABLET;ORAL

SYNJARDY

BOEHRINGER INGELHEIM
5MG;500MG

5MG;1GM

12.5MG;500MG

+
12.5MG;1GM

EMTRICITABINE

CAPSULE;ORAL

EMTRIVA

+ GILEAD
SOLUTION;ORAL

EMTRIVA

+ GILEAD

N206111
N206111
N206111
N206111

001
002
003
004

Aug
Aug
Aug
Aug

26,
26,
26,
26,

2015

2015

2015

2015

200MG

N021500 001 Jul 02, 2003

10MG/ML

N021896 001 Sep 28, 2005

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

COMPLERA

+ GILEAD SCIENCES INC
200MG;EQ 25MG BASE;300MG

N202123 001 Aug 10, 2011

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

TRUVADA

+ GILEAD
200MG;300MG

N021752 001 Aug 02, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-135(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ENALAPRIL MALEATE

FOR SOLUTION;ORAL

EPANED KIT

+ SILVERGATE PHARMS
TABLET;ORAL

ENALAPRIL MALEATE

AB
APOTEX
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
SANDOZ INC
AB
AB
AB
AB
TARO
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
WOCKHARDT USA
AB
AB
AB
VASOTEC

AB
VALEANT PHARMS NORTH
AB
AB
AB
+

1MG/ML

N204308 001 Aug 13, 2013

2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG

A075178
A075178
A075178
A075178
A075480
A075480
A075480
A075480
A075496
A075496
A075459
A075459
A075657
A075657
A075657
A075657
A075479
A075479
A075479
A075479
A075483
A075483
A075483
A075483

002
001
003
004
001
002
003
004
001
002
001
002
001
002
003
004
001
002
003
004
001
002
003
004

Mar
Mar
Mar
Mar
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

23,
23,
23,
23,
22,
22,
22,
22,
22,
22,
22,
22,
23,
23,
23,
23,
22,
22,
22,
22,
22,
22,
22,
22,

2001

2001

2001

2001

2000

2000

2000

2000

2000

2000

2000

2000

2001

2001

2001

2001

2000

2000

2000

2000

2000

2000

2000

2000

2.5MG
5MG
10MG
20MG

N018998
N018998
N018998
N018998

005
001
002
003

Jul
Dec
Dec
Dec

26,
24,
24,
24,

1988

1985

1985

1985

A076486
A076486
A075909
A075909
A075727
A075727
A075624
A075624
A075788
A075788

001
002
001
002
001
002
001
002
001
002

Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
15,
15,
18,
18,
18,
18,
18,
18,

2004

2004

2001

2001

2001

2001

2001

2001

2001

2001

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

AB
APOTEX INC
5MG;12.5MG
AB
10MG;25MG
AB
DR REDDYS LABS LTD
5MG;12.5MG
AB
10MG;25MG
AB
G AND W LABS INC
5MG;12.5MG
AB
10MG;25MG
AB
MYLAN
5MG;12.5MG
AB
10MG;25MG
AB
TARO PHARM INDS
5MG;12.5MG
AB
10MG;25MG
VASERETIC

AB
VALEANT INTL
5MG;12.5MG
AB
+
10MG;25MG

N019221 003 Jul 12, 1995

N019221 001 Oct 31, 1986

ENALAPRILAT

INJECTABLE;INJECTION

ENALAPRILAT

AP
+ BEDFORD
AP
HIKMA FARMACEUTICA
AP
+ HOSPIRA
AP
TEVA PHARMS USA

1.25MG/ML
1.25MG/ML
1.25MG/ML
1.25MG/ML

A075634
A078687
A075458
A075578

99.9%

A074396 001 Jul 29, 1994

99.9%

N017087 001

ENFLURANE

LIQUID;INHALATION

ENFLURANE

AN
PIRAMAL CRITICAL
ETHRANE

AN
+ BAXTER HLTHCARE

001
001
001
001

Aug
Dec
Aug
Aug

22,
23,
22,
22,

2000

2008

2000

2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-136(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ENFUVIRTIDE

INJECTABLE;SUBCUTANEOUS

FUZEON

+ ROCHE

90MG/VIAL

ENOXAPARIN SODIUM

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

ENOXAPARIN SODIUM

AB
SANDOZ INC
300MG/3ML (100MG/ML)
LOVENOX

AB
SANOFI AVENTIS US
300MG/3ML (100MG/ML)
INJECTABLE;SUBCUTANEOUS

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

AP
AMPHASTAR PHARM
30MG/0.3ML (100MG/ML)
AP
40MG/0.4ML (100MG/ML)
AP
60MG/0.6ML (100MG/ML)
AP
80MG/0.8ML (100MG/ML)
AP
100MG/ML (100MG/ML)
AP
120MG/0.8ML (150MG/ML)
AP
150MG/ML (150MG/ML)
AP
SANDOZ
30MG/0.3ML (100MG/ML)
AP
40MG/0.4ML (100MG/ML)
AP
60MG/0.6ML (100MG/ML)
AP
80MG/0.8ML (100MG/ML)
AP
100MG/ML (100MG/ML)
AP
120MG/0.8ML (150MG/ML)
AP
150MG/ML (150MG/ML)
AP
TEVA
30MG/0.3ML (100MG/ML)
AP
40MG/0.4ML (100MG/ML)
AP
60MG/0.6ML (100MG/ML)
AP
80MG/0.8ML (100MG/ML)
AP
100MG/ML (100MG/ML)
AP
120MG/0.8ML (150MG/ML)
AP
150MG/ML (150MG/ML)
LOVENOX (PRESERVATIVE FREE)

AP
SANOFI AVENTIS US
30MG/0.3ML (100MG/ML)
AP
40MG/0.4ML (100MG/ML)
AP
60MG/0.6ML (100MG/ML)
AP
80MG/0.8ML (100MG/ML)
AP
+
100MG/ML (100MG/ML)
AP
120MG/0.8ML (150MG/ML)
AP
150MG/ML (150MG/ML)
ENTACAPONE

TABLET;ORAL

COMTAN

AB
+ ORION PHARMA
ENTACAPONE

AB
AUROBINDO PHARMA LTD
AB
MYLAN PHARMS INC
AB
SUN PHARMA GLOBAL
AB
WOCKHARDT LTD
ENTECAVIR

SOLUTION;ORAL

BARACLUDE

+ BRISTOL MYERS SQUIBB
TABLET;ORAL

BARACLUDE

AB
BRISTOL MYERS SQUIBB
AB
+
ENTECAVIR

AB
AMNEAL PHARMS
AB
AB
AUROBINDO PHARMA LTD
AB
AB
HETERO LABS LTD V
AB
AB
TEVA PHARMS USA
AB

N021481 001 Mar 13, 2003

A078660 001 Nov 28, 2011

N020164 009 Jan 23, 2003

A076684
A076684
A076684
A076684
A076684
A076684
A076684
A077857
A077857
A077857
A077857
A077857
A077857
A077857
A076726
A076726
A076726
A076726
A076726
A076726
A076726

001
002
003
004
005
006
007
002
003
004
005
001
006
007
001
002
003
004
005
006
007

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jun
Jun
Jun
Jun
Jun
Jun
Jun

19,
19,
19,
19,
19,
19,
19,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,

2011

2011

2011

2011

2011

2011

2011

2010

2010

2010

2010

2010

2010

2010

2014

2014

2014

2014

2014

2014

2014

N020164
N020164
N020164
N020164
N020164
N020164
N020164

001
002
003
004
005
007
008

Mar
Jan
Mar
Mar
Mar
Jun
Jun

29,
30,
27,
27,
27,
02,
02,

1993

1998

1998

1998

1998

2000

2000

200MG

N020796 001 Oct 19, 1999

200MG
200MG
200MG
200MG

A203437
A202394
A090690
A078941

0.05MG/ML

N021798 001 Mar 29, 2005

0.5MG
1MG

N021797 001 Mar 29, 2005

N021797 002 Mar 29, 2005

0.5MG
1MG
0.5MG
1MG
0.5MG
1MG
0.5MG
1MG

A206652
A206652
A206217
A206217
A205740
A205740
A202122
A202122

001
001
001
001

001
002
001
002
001
002
001
002

Jun
May
Jul
Aug

Nov
Nov
Aug
Aug
Aug
Aug
Aug
Aug

19,
13,
16,
16,

12,
12,
26,
26,
21,
21,
26,
26,

2015

2013

2012

2012

2015

2015

2015

2015

2015

2015

2014

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-137(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ENZALUTAMIDE

CAPSULE;ORAL

XTANDI

+ ASTELLAS
EPINASTINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

ELESTAT

AT
+ ALLERGAN
EPINASTINE HYDROCHLORIDE

AT
APOTEX
AT
BRECKENRIDGE PHARM
AT
GAVIS PHARMS LLC
AT
SUN PHARM INDS

40MG

N203415 001 Aug 31, 2012

0.05%

N021565 001 Oct 16, 2003

0.05%
0.05%
0.05%
0.05%

A090919
A090870
A090951
A091626

EPINEPHRINE

INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS

ADRENALIN

+ PAR STERILE PRODUCTS
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

ADRENACLICK

BX
+ AMEDRA PHARMS
EQ 0.15MG/DELIVERY
BX
+
EQ 0.3MG/DELIVERY
AUVI-Q

BX
+ SANOFI AVENTIS US
EQ 0.15MG/DELIVERY
BX
EQ 0.3MG/DELIVERY
EPIPEN

BX
+ MYLAN SPECLT
0.3MG/DELIVERY
EPIPEN JR.

BX
+ MYLAN SPECLT
0.15MG/DELIVERY
TWINJECT 0.15

BX
+ AMEDRA PHARMS
EQ 0.15MG/DELIVERY
TWINJECT 0.3

BX
+ AMEDRA PHARMS
EQ 0.3MG/DELIVERY
ADRENALIN

+ PAR STERILE PRODUCTS
EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIGNOSPAN FORTE

+ DEPROCO
EQ 0.02MG BASE/ML;2%
LIGNOSPAN STANDARD

+ DEPROCO
EQ 0.01MG BASE/ML;2%
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CITANEST FORTE DENTAL

AP
+ DENTSPLY PHARM
0.005MG/ML;4%
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

AP
SEPTODONT INC
0.005MG/ML;4%
EPINEPHRINE HYDROCHLORIDE

SOLUTION;IV (INFUSION), INTRAOCULAR

EPINEPHRINE

BELCHER PHARMS LLC
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

AP
EASTMAN KODAK
0.01MG/ML;2%
AP
0.02MG/ML;2%
AP
HOSPIRA
0.005MG/ML;0.5%
AP
0.005MG/ML;1.5%
AP
0.005MG/ML;1.5%
AP
0.005MG/ML;2%
AP
0.01MG/ML;1%
AP
0.01MG/ML;2%
AP
0.01MG/ML;2%
AP
0.02MG/ML;2%
OCTOCAINE

AP
+ SEPTODONT
0.01MG/ML;2%
AP
+
0.02MG/ML;2%
XYLOCAINE W/ EPINEPHRINE

AP
+ FRESENIUS KABI USA
0.005MG/ML;0.5%
AP
+
0.005MG/ML;1%

001
001
001
001

Oct
Mar
Oct
Oct

31,
14,
31,
31,

2011

2011

2011

2011

N204200 001 Dec 07, 2012

N020800 003 Nov 25, 2009

N020800 004 Nov 25, 2009

N201739 002 Aug 10, 2012

N201739 001 Aug 10, 2012

N019430 001 Dec 22, 1987

N019430 002 Dec 22, 1987

N020800 002 May 28, 2004

N020800 001 May 30, 2003

N204640 001 Dec 18, 2013

A088389 001 Jan 22, 1985

A088390 001 Jan 22, 1985

N021383 001

A078959 001 Aug 30, 2011

N205029 001 Jul 29, 2014

A040057
A040057
A089635
A088571
A089645
A089651
A089644
A078772
A089646
A078772

002
001
001
001
001
001
001
001
001
002

Feb
Feb
Jun
Sep
Jun
Jun
Jun
May
Jun
May

26,
26,
21,
13,
21,
21,
21,
12,
21,
12,

1993

1993

1988

1985

1988

1988

1988

2008

1988

2008

A084048 001

A084048 002

N006488 012

N006488 018 Nov 13, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-138(of 388)

PRESCRIPTION DRUG PRODUCT LIST

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

XYLOCAINE W/ EPINEPHRINE

AP
+
0.005MG/ML;1.5%
AP
+
0.005MG/ML;2%
AP
+
0.01MG/ML;1%
AP
+
0.02MG/ML;2%
EPIRUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

ELLENCE

AP
+ PFIZER INC
AP
EPIRUBICIN HYDROCHLORIDE

AP
ACTAVIS TOTOWA
AP
AP
AP
AKORN INC
AP
CIPLA LTD
AP
AP
EUROHLTH INTL SARL
AP
AP
FRESENIUS KABI ONCOL
AP
AP
FRESENIUS KABI USA
AP
AP
AP
AP
HISUN PHARM HANGZHOU
AP
AP
HOSPIRA
AP
AP
AP
MYLAN LABS LTD
AP
AP
TEVA PHARMS USA
AP
EPLERENONE

TABLET;ORAL

EPLERENONE

AB
APOTEX
AB
AB
SANDOZ
AB
INSPRA

AB
GD SEARLE LLC
AB
+
EPOPROSTENOL SODIUM

INJECTABLE;INJECTION

EPOPROSTENOL SODIUM

AP
TEVA PHARMS USA
AP
FLOLAN

AP
+ GLAXOSMITHKLINE LLC
AP
+
VELETRI

ACTELION PHARMS LTD
+
EPROSARTAN MESYLATE

TABLET;ORAL

EPROSARTAN MESYLATE

AB
MYLAN PHARMS INC
AB
TEVETEN

AB
ABBVIE
AB
+

N006488
N006488
N006488
N006488

017

019 Nov 13, 1986

004

005

200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)

N050778 001 Sep 15, 1999

N050778 002 Sep 15, 1999

10MG/5ML (2MG/ML)
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
10MG/5ML (2MG/ML)
50MG/25ML (2MG/ML)
150MG/75ML (2MG/ML)
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)
10MG/5ML (2MG/ML)
150MG/75ML (2MG/ML)
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)

A065445
A065445
A065445
A090163
A065361
A065361
A065289
A065289
A065411
A065411
A065408
A065408
A065408
A065408
A090075
A090075
A065343
A065343
A065343
A091599
A091599
A065331
A065331

001
002
003
001
001
002
001
002
001
002
001
002
003
004
001
002
001
003
004
001
002
001
002

Sep
Sep
Sep
Jun
Oct
Oct
Jun
Jun
Aug
Aug
Oct
Oct
Oct
Oct
Mar
Mar
Apr
Apr
Apr
Mar
Mar
Aug
Aug

18,
18,
18,
24,
22,
22,
27,
27,
20,
20,
15,
15,
15,
15,
25,
25,
19,
19,
19,
12,
12,
09,
09,

2008

2008

2008

2009

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2010

2010

2007

2007

2007

2012

2012

2007

2007

25MG
50MG
25MG
50MG

A078482
A078482
A078510
A078510

001
002
001
002

Jul
Jul
Aug
Aug

30,
30,
01,
01,

2008

2008

2008

2008

25MG
50MG

N021437 001 Sep 27, 2002

N021437 002 Sep 27, 2002

EQ 0.5MG BASE/VIAL
EQ 1.5MG BASE/VIAL

A078396 001 Apr 23, 2008

A078396 002 Apr 23, 2008

EQ 0.5MG BASE/VIAL
EQ 1.5MG BASE/VIAL

N020444 001 Sep 20, 1995

N020444 002 Sep 20, 1995

EQ 0.5MG BASE/VIAL
EQ 1.5MG BASE/VIAL

N022260 002 Jun 28, 2012

N022260 001 Jun 27, 2008

EQ 400MG BASE
EQ 600MG BASE

A202012 001 Nov 16, 2011

A202012 002 Nov 16, 2011

EQ 400MG BASE
EQ 600MG BASE

N020738 005 Dec 22, 1997

N020738 006 May 27, 1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-139(of 388)

PRESCRIPTION DRUG PRODUCT LIST

EPTIFIBATIDE

INJECTABLE;INJECTION

EPTIFIBATIDE

AP
AUROBINDO PHARMA LTD
AP
AP
TEVA PHARMS USA
AP
INTEGRILIN

AP
+ SCHERING
AP
+
ERGOCALCIFEROL

CAPSULE;ORAL

DRISDOL

AA
+ SANOFI AVENTIS US
ERGOCALCIFEROL

AA
ORIT LABS LLC
AA
SIGMAPHARM LABS LLC
AA
STRIDES PHARMA
AA
SUN PHARM INDS INC
VITAMIN D

AA
BANNER LIFE SCIENCES

2MG/ML
75MG/100ML
2MG/ML
75MG/100ML

A206127
A206127
A090854
A091555

2MG/ML
75MG/100ML

N020718 001 May 18, 1998

N020718 002 May 18, 1998

50,000 IU

N003444 001

50,000
50,000
50,000
50,000

A040833
A091004
A090455
A040865

IU
IU
IU
IU

001
002
001
001

001
001
001
001

Dec
Dec
Jun
Jun

May
Jul
Aug
Dec

08,
08,
12,
05,

20,
14,
03,
29,

2015

2015

2015

2015

2009

2010

2010

2009

50,000 IU

A080704 001

1MG

A081113 001 Oct 31, 1991

1MG

N017993 001

ERGOTAMINE TARTRATE

TABLET;SUBLINGUAL

ERGOMAR

+ ROSEDALE THERAPEUTIC

2MG

A087693 001 Feb 24, 1983

ERIBULIN MESYLATE

SOLUTION;INTRAVENOUS

HALAVEN

+ EISAI INC

1MG/2ML (0.5MG/ML)

N201532 001 Nov 15, 2010

EQ 25MG BASE
EQ 100MG BASE
EQ 150MG BASE

N021743 001 Nov 18, 2004

N021743 002 Nov 18, 2004

N021743 003 Nov 18, 2004

ERGOLOID MESYLATES

TABLET;ORAL

ERGOLOID MESYLATES

AB
MUTUAL PHARM
HYDERGINE

AB
+ NOVARTIS

ERLOTINIB HYDROCHLORIDE

TABLET;ORAL

TARCEVA

OSI PHARMS
+

ERTAPENEM SODIUM

INJECTABLE;INTRAMUSCULAR, IV (INFUSION)

INVANZ

+ MERCK SHARP DOHME
EQ 1GM BASE/VIAL
ERYTHROMYCIN

CAPSULE, DELAYED REL PELLETS;ORAL

ERYC

AB
+ MAYNE PHARMA
250MG
ERYTHROMYCIN

AB
ARBOR PHARMS LLC
250MG
GEL;TOPICAL

ERYGEL

AT
+ DELCOR ASSET CORP
2%
ERYTHROMYCIN

AT
FOUGERA PHARMS
2%
AT
PERRIGO
2%
OINTMENT;OPHTHALMIC

ERYTHROMYCIN

AT
AKORN
0.5%
AT
BAUSCH AND LOMB
0.5%
AT
+ PERRIGO CO TENNESSEE
0.5%
OINTMENT;TOPICAL

AKNE-MYCIN

+ DOW PHARM
2%
SOLUTION;TOPICAL

C-SOLVE-2

AT
FOUGERA PHARMS
2%

N021337 001 Nov 21, 2001

N050536 001

A062746 001 Dec 22, 1986

N050617 001 Oct 21, 1987

A064184 001 Sep 30, 1997

A063211 001 Jan 29, 1993

A064030 001 Jul 18, 1996

A064067 001 Jul 29, 1994

A062447 001 Sep 26, 1983

N050584 001 Jan 10, 1985

A062468 001 Jul 03, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-140(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ERYTHROMYCIN

SOLUTION;TOPICAL

ERYTHRO-STATIN

AT
HI TECH PHARMA
2%
ERYTHROMYCIN

AT
FOUGERA PHARMS
2%
AT
+ PERRIGO NEW YORK
2%
AT
WOCKHARDT
2%
SWAB;TOPICAL

ERYTHROMYCIN

AT
+ PERRIGO
2%
AT
VERSAPHARM
2%
TABLET;ORAL

ERYTHROMYCIN

ARBOR PHARMS LLC
250MG
+
500MG
TABLET, COATED PARTICLES;ORAL

PCE

ARBOR PHARMS LLC
333MG
+
500MG
TABLET, DELAYED RELEASE;ORAL

ERY-TAB

ARBOR PHARMS LLC
250MG
333MG
+
500MG
ERYTHROMYCIN ETHYLSUCCINATE

GRANULE;ORAL

E.E.S.

AB
ARBOR PHARMS LLC
EQ
ERYPED

AB
ARBOR PHARMS LLC
EQ
+
EQ
TABLET;ORAL

E.E.S. 400

BX
+ ARBOR PHARMS LLC
EQ
ERYTHROMYCIN ETHYLSUCCINATE

BX
+ ARBOR PHARMS LLC
EQ

A064101 001 Oct 22, 1996

A064187 001 Sep 30, 1997

A063038 001 Jan 11, 1991

A062825 001 Oct 23, 1987

A064126 001 Jul 03, 1996

A090215 001 May 12, 2010

A061621 001

A061621 002

N050611 001 Sep 09, 1986

N050611 002 Aug 22, 1990

A062298 001

A062298 003 Mar 29, 1982

A062298 002

200MG BASE/5ML

N050207 001

200MG BASE/5ML
400MG BASE/5ML

N050207 003 Mar 30, 1987

N050207 002

400MG BASE

A061905 002 Aug 12, 1982

400MG BASE

A061904 001

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL

GRANULE;ORAL

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

+ BARR
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML

A062759 001 May 20, 1988

ERYTHROMYCIN LACTOBIONATE

INJECTABLE;INJECTION

ERYTHROCIN

AP
HOSPIRA
AP
+
+

EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL

A062638 001 Oct 31, 1986

N050609 001 Sep 24, 1986

A062638 002 Oct 31, 1986

ERYTHROMYCIN STEARATE

TABLET;ORAL

ERYTHROCIN STEARATE

+ ARBOR PHARMS LLC

EQ 250MG BASE

A060359 001

EQ
EQ
EQ
EQ
EQ
EQ

A202227
A203967
A079062
A202221
A090477
A079121

ESCITALOPRAM OXALATE

SOLUTION;ORAL

ESCITALOPRAM OXALATE

AA
AMNEAL PHARMS
AA
ANTRIM PHARMS LLC
AA
AUROBINDO PHARMA LTD
AA
HETERO LABS LTD III
AA
SILARX PHARMS INC
AA
TARO
LEXAPRO

AA
+ FOREST LABS
TABLET;ORAL

ESCITALOPRAM OXALATE

AB
ACCORD HLTHCARE
AB
AB
AB
APOTEX INC
AB
AB

5MG
5MG
5MG
5MG
5MG
5MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

001
001
001
001
001
001

Mar
May
Apr
Jun
Jun
May

14,
26,
02,
12,
12,
03,

2012

2015

2012

2012

2013

2012

EQ 5MG BASE/5ML

N021365 001 Nov 27, 2002

EQ
EQ
EQ
EQ
EQ
EQ

A202389
A202389
A202389
A078777
A078777
A078777

5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE

001
002
003
001
002
003

Sep
Sep
Sep
Sep
Sep
Sep

11,
11,
11,
11,
11,
11,

2012

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-141(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ESCITALOPRAM OXALATE

TABLET;ORAL

ESCITALOPRAM OXALATE

AB
AUROBINDO PHARMA LTD
AB
AB
AB
HIKMA PHARMS
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
JUBILANT GENERICS
AB
AB
AB
LUPIN LTD
AB
AB
AB
MACLEODS PHARMS LTD
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
PRINSTON INC
AB
AB
AB
STI PHARMA LLC
AB
AB
AB
TEVA PHARMS USA
AB
AB
AB
TORRENT PHARMS LTD
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
LEXAPRO

AB
FOREST LABS
AB
AB
+
ESLICARBAZEPINE ACETATE

TABLET;ORAL

APTIOM

SUNOVION PHARMS INC

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE

A090432
A090432
A090432
A078766
A078766
A078766
A078604
A078604
A078604
A202280
A202280
A202280
A078169
A078169
A078169
A202210
A202210
A202210
A077550
A077550
A077550
A078032
A078032
A078032
A077512
A077512
A077512
A076765
A076765
A076765
A090939
A090939
A090939
A077734
A077734
A077734

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
May
May
May
Aug
Aug
Aug
Sep
Sep
Sep
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep

11,
11,
11,
11,
11,
11,
11,
11,
11,
12,
12,
12,
11,
11,
11,
11,
11,
11,
14,
14,
14,
28,
28,
28,
12,
12,
12,
14,
14,
14,
11,
11,
11,
11,
11,
11,

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2015

2015

2015

2015

2015

2015

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE

N021323 001 Aug 14, 2002

N021323 002 Aug 14, 2002

N021323 003 Aug 14, 2002

200MG
400MG
600MG
800MG

N022416
N022416
N022416
N022416

ESMOLOL HYDROCHLORIDE

INJECTABLE;INJECTION

BREVIBLOC

AP
+ BAXTER HLTHCARE
10MG/ML
ESMOLOL HYDROCHLORIDE

AP
AUROBINDO PHARMA LTD
10MG/ML
AP
EUROHLTH INTL SARL
10MG/ML
AP
FRESENIUS KABI USA
10MG/ML
AP
LUITPOLD
10MG/ML
AP
MYLAN INSTITUTIONAL
10MG/ML
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
2GM/100ML
BREVIBLOC IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
1GM/100ML
ESOMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED REL PELLETS;ORAL

ESOMEPRAZOLE MAGNESIUM

AB
DR REDDYS LABS LTD
EQ 20MG
AB
EQ 40MG
AB
HETERO LABS LTD III
EQ 20MG
AB
EQ 40MG

BASE
BASE
BASE
BASE

001
002
003
004

Nov
Nov
Nov
Nov

08,
08,
08,
08,

2013

2013

2013

2013

N019386 006 Feb 25, 2003

A205520
A076323
A076573
A201126
A076474

001
001
001
001
001

Jul
Aug
May
Feb
May

23,
10,
02,
20,
02,

2015

2004

2005

2015

2005

N019386 005 Jan 27, 2003

N019386 004 Feb 16, 2001

A078279
A078279
A202784
A202784

001
002
001
002

Sep
Sep
Sep
Sep

25,
25,
21,
21,

2015

2015

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-142(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ESOMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED REL PELLETS;ORAL

ESOMEPRAZOLE MAGNESIUM

AB
IVAX SUB TEVA PHARMS
EQ 20MG BASE

AB

EQ 40MG BASE

AB
MYLAN PHARMS INC

EQ 20MG BASE

AB

EQ 40MG BASE

AB
TORRENT PHARMS LTD

EQ 20MG BASE

AB

EQ 40MG BASE

NEXIUM

AB
ASTRAZENECA PHARMS

EQ 20MG BASE

AB
+

EQ 40MG BASE

FOR SUSPENSION, DELAYED RELEASE;ORAL

NEXIUM

ASTRAZENECA PHARMS
EQ 2.5MG BASE/PACKET

EQ 5MG BASE/PACKET

EQ 10MG BASE/PACKET

EQ 20MG BASE/PACKET

+
EQ 40MG BASE/PACKET

A078003
A078003
A078936
A078936
A203636
A203636

001
002
001
002
001
002

Jan
Jan
Aug
Aug
Oct
Oct

26,
26,
02,
03,
19,
19,

2015

2015

2015

2015

2015

2015

N021153 001 Feb 20, 2001

N021153 002 Feb 20, 2001

N021957
N021957
N022101
N021957
N021957

003
004
001
001
002

Dec
Dec
Feb
Oct
Oct

15,
15,
27,
20,
20,

2011

2011

2008

2006

2006

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

TABLET, DELAYED RELEASE;ORAL

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

AB
DR REDDYS LABS LTD

EQ 20MG BASE;375MG

AB

EQ 20MG BASE;500MG

VIMOVO

AB
HORIZON PHARMA

EQ 20MG BASE;375MG

AB
+

EQ 20MG BASE;500MG

A202461 001 Sep 27, 2013

A202461 002 Sep 27, 2013

ESOMEPRAZOLE SODIUM

INJECTABLE;INTRAVENOUS

ESOMEPRAZOLE SODIUM

AP
ACCORD HLTHCARE

AP
SUN PHARMA GLOBAL

AP

NEXIUM IV

AP
+ ASTRAZENECA PHARMS

AP
+

EQ 40MG BASE/VIAL

EQ 20MG BASE/VIAL

EQ 40MG BASE/VIAL

A205379 001 Sep 25, 2015

A200882 001 Mar 18, 2013

A200882 002 Mar 18, 2013

EQ 20MG BASE/VIAL

EQ 40MG BASE/VIAL

N021689 001 Mar 31, 2005

N021689 002 Mar 31, 2005

N022511 002 Apr 30, 2010

N022511 001 Apr 30, 2010

ESOMEPRAZOLE STRONTIUM

CAPSULE, DELAYED RELEASE;ORAL

ESOMEPRAZOLE STRONTIUM

HANMI PHARM CO LTD

24.65MG

+

49.3MG

N202342 001 Aug 06, 2013

N202342 002 Aug 06, 2013

ESTAZOLAM

TABLET;ORAL

ESTAZOLAM

AB
PAR PHARM
AB
AB
TEVA
AB
+
AB
WATSON LABS
AB

A074826
A074826
A074921
A074921
A074818
A074818

1MG

2MG

1MG

2MG

1MG

2MG

ESTRADIOL

CREAM;VAGINAL

ESTRACE

+ WARNER CHILCOTT US

0.01%

FILM, EXTENDED RELEASE;TRANSDERMAL

CLIMARA

AB
BAYER HLTHCARE

0.0375MG/24HR

AB

0.06MG/24HR

ESTRADIOL

AB
MYLAN TECHNOLOGIES

0.0375MG/24HR

AB

0.06MG/24HR

AB1

0.025MG/24HR

AB1

0.0375MG/24HR

AB1

0.05MG/24HR

AB1

0.075MG/24HR

AB1

0.1MG/24HR

VIVELLE

AB1
NOVARTIS

0.05MG/24HR

AB1

0.1MG/24HR

001
002
001
002
001
002

Jul
Jul
Jul
Jul
Aug
Aug

03,
03,
10,
10,
19,
19,

1997

1997

1997

1997

1997

1997

A086069 001 Jan 31, 1984

N020375 005 May 27, 2003

N020375 006 May 27, 2003

A075182
A075182
A201675
A201675
A201675
A201675
A201675

004
005
001
002
003
004
005

Jul
Jul
Dec
Dec
Dec
Dec
Dec

20,
20,
19,
19,
19,
19,
19,

2006

2006

2014

2014

2014

2014

2014

N020323 002 Oct 28, 1994

N020323 004 Oct 28, 1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-143(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ESTRADIOL

FILM, EXTENDED RELEASE;TRANSDERMAL

VIVELLE-DOT

AB1
NOVARTIS
0.025MG/24HR
AB1
0.0375MG/24HR
AB1
0.05MG/24HR
AB1
0.075MG/24HR
AB1 +
0.1MG/24HR
CLIMARA

AB2
BAYER HLTHCARE
0.025MG/24HR
AB2
0.05MG/24HR
AB2
0.075MG/24HR
AB2 +
0.1MG/24HR
ESTRADIOL

AB2
MYLAN TECHNOLOGIES
0.025MG/24HR
AB2
0.05MG/24HR
AB2
0.075MG/24HR
AB2
0.1MG/24HR
ALORA

BX
ACTAVIS LABS UT INC
0.025MG/24HR
BX
0.05MG/24HR
BX
0.075MG/24HR
BX
0.1MG/24HR
ESTRADERM

BX
NOVARTIS
0.05MG/24HR
BX
+
0.1MG/24HR
MENOSTAR

+ BAYER HLTHCARE
0.014MG/24HR
MINIVELLE

NOVEN
0.025MG/24HR
0.0375MG/24HR
0.05MG/24HR
0.075MG/24HR
+
0.1MG/24HR
GEL;TRANSDERMAL

DIVIGEL

VERTICAL PHARMS LLC
0.1% (0.25GM/PACKET)
0.1% (0.5GM/PACKET)
+
0.1% (1GM/PACKET)
GEL, METERED;TRANSDERMAL

ELESTRIN

+ MEDA PHARMS
0.06% (0.87GM/ACTIVATION)
ESTROGEL

+ ASCEND THERAPS US
0.06% (1.25GM/ACTIVATION)
INSERT, EXTENDED RELEASE;VAGINAL

ESTRING

+ PHARMACIA AND UPJOHN
0.0075MG/24HR
SPRAY;TRANSDERMAL

EVAMIST

+ ELAN PHARMA INTL LTD
1.53MG/SPRAY
TABLET;ORAL

ESTRADIOL

AB
BARR LABS INC
0.5MG
AB
1MG
AB
+
2MG
AB
MYLAN
0.5MG
AB
1MG
AB
2MG
AB
USL PHARMA
0.5MG
AB
1MG
AB
2MG
AB
WATSON LABS
0.5MG
AB
1MG
AB
2MG
TABLET;VAGINAL

VAGIFEM

+ NOVO NORDISK INC
10MCG

N020538
N020538
N020538
N020538
N020538

009
005
006
007
008

May
Jan
Jan
Jan
Jan

03,
08,
08,
08,
08,

2002

1999

1999

1999

1999

N020375
N020375
N020375
N020375

004
001
003
002

Mar
Dec
Mar
Dec

05,
22,
23,
22,

1999

1994

1998

1994

A075182
A075182
A075182
A075182

003
006
002
001

Jan
Feb
Jan
Feb

26,
24,
26,
24,

2005

2000

2005

2000

N020655
N020655
N020655
N020655

004
001
002
003

Apr
Dec
Dec
Dec

05,
20,
20,
20,

2002

1996

1996

1996

N019081 002 Sep 10, 1986

N019081 003 Sep 10, 1986

N021674 001 Jun 08, 2004

N203752
N203752
N203752
N203752
N203752

005
001
003
002
004

Sep
Oct
Oct
Oct
Oct

23,
29,
29,
29,
29,

2014

2012

2012

2012

2012

N022038 001 Jun 04, 2007

N022038 002 Jun 04, 2007

N022038 003 Jun 04, 2007

N021813 001 Dec 15, 2006

N021166 002 Feb 09, 2004

N020472 001 Apr 26, 1996

N022014 001 Jul 27, 2007

A040197
A040197
A040197
A040326
A040326
A040326
A040297
A040297
A040297
A040114
A040114
A040114

001
002
003
001
002
003
001
002
003
003
001
002

Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Apr
Mar
Mar
Mar

22,
22,
22,
21,
21,
21,
17,
17,
17,
14,
14,
14,

1997

1997

1997

1999

1999

1999

2002

2002

2002

1996

1996

1996

N020908 002 Nov 25, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-144(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ESTRADIOL ACETATE

INSERT, EXTENDED RELEASE;VAGINAL

FEMRING

WARNER IRELAND
EQ 0.05MG BASE/24HR
+
EQ 0.1MG BASE/24HR
TABLET;ORAL

FEMTRACE

WARNER CHILCOTT LLC
0.45MG
0.9MG
+
1.8MG

N021633 001 Aug 20, 2004

N021633 002 Aug 20, 2004

N021633 003 Aug 20, 2004

ESTRADIOL CYPIONATE

INJECTABLE;INJECTION

DEPO-ESTRADIOL

+ PHARMACIA AND UPJOHN

5MG/ML

A085470 003

ESTRADIOL HEMIHYDRATE

EMULSION;TOPICAL

ESTRASORB

+ MEDICIS

0.25%

N021371 001 Oct 09, 2003

20MG/ML
40MG/ML

N009402 004

N009402 003

20MG/ML
40MG/ML

A090920 001 Jan 19, 2010

A090920 002 Jan 19, 2010

10MG/ML

N009402 002

ESTRADIOL VALERATE

INJECTABLE;INJECTION

DELESTROGEN

AO
+ PAR STERILE PRODUCTS
AO
+
ESTRADIOL VALERATE

AO
LUITPOLD
AO
DELESTROGEN

+ PAR STERILE PRODUCTS

ESTRADIOL; LEVONORGESTREL

FILM, EXTENDED RELEASE;TRANSDERMAL

CLIMARA PRO

+ BAYER HLTHCARE
0.045MG/24HR;0.015MG/24HR

N021367 001 Mar 20, 2003

N021367 002 Mar 20, 2003

N021258 001 Nov 21, 2003

ESTRADIOL; NORETHINDRONE ACETATE

FILM, EXTENDED RELEASE;TRANSDERMAL

COMBIPATCH

NOVEN PHARMS INC
0.05MG/24HR;0.14MG/24HR
+
0.05MG/24HR;0.25MG/24HR
TABLET;ORAL

ACTIVELLA

AB
AMNEAL PHARMS LLC
0.5MG;0.1MG
AB
+
1MG;0.5MG
ESTRADIOL AND NORETHINDRONE ACETATE

AB
BARR
1MG;0.5MG
AB
BRECKENRIDGE PHARM
0.5MG;0.1MG
AB
1MG;0.5MG
AB
TEVA PHARMS USA
0.5MG;0.1MG

A079193
A078324
A078324
A200747

ESTRADIOL; NORGESTIMATE

TABLET;ORAL

ESTRADIOL AND NORGESTIMATE

+ BARR
1MG,1MG;1MG,1MG;N/A,0.09MG

A076812 001 Apr 29, 2005

ESTRAMUSTINE PHOSPHATE SODIUM

CAPSULE;ORAL

EMCYT

+ PHARMACIA AND UPJOHN

EQ 140MG PHOSPHATE

N018045 001

0.625MG/GM

N020216 001

25MG/VIAL

N010402 001

0.3MG
0.45MG
0.625MG
0.9MG
1.25MG

N004782
N004782
N004782
N004782
N004782

ESTROGENS, CONJUGATED

CREAM;TOPICAL, VAGINAL

PREMARIN

+ WYETH PHARMS INC
INJECTABLE;INJECTION

PREMARIN

+ WYETH PHARMS INC
TABLET;ORAL

PREMARIN

WYETH PHARMS INC
+
+
+

N020870 001 Aug 07, 1998

N020870 002 Aug 07, 1998

N020907 002 Dec 28, 2006

N020907 001 Nov 18, 1998

001
002
001
001

May
Jun
Apr
Mar

11,
09,
17,
08,

2010

2011

2008

2012

003

006 Jul 16, 2003

004

005 Jan 26, 1984

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-145(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ESTROGENS, CONJUGATED SYNTHETIC A

TABLET;ORAL

CENESTIN

TEVA BRANDED PHARM
0.3MG
0.45MG
0.625MG
0.9MG
+
1.25MG

N020992
N020992
N020992
N020992
N020992

001
005
002
003
004

Jun
Feb
Mar
Mar
Mar

21,
05,
24,
24,
13,

2002

2004

1999

1999

2000

ESTROGENS, CONJUGATED SYNTHETIC B

TABLET;ORAL

ENJUVIA

TEVA WOMENS
0.3MG
0.45MG
0.625MG
0.9MG
+
1.25MG

N021443
N021443
N021443
N021443
N021443

001
002
003
005
004

Dec
Dec
May
Apr
May

20,
20,
10,
27,
10,

2004

2004

2004

2007

2004

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

TABLET;ORAL-28

PREMPHASE 14/14

+ WYETH PHARMS INC

0.625MG,0.625MG;0.625MG,0.625MG;N/A,5MG
PREMPRO

+ WYETH PHARMS INC
0.3MG;1.5MG
+
0.45MG;1.5MG
+
0.625MG;0.625MG;2.5MG;2.5MG
+
0.625MG;0.625MG;5MG;5MG

N020527
N020527
N020527
N020527

005
004
001
003

0.3MG
0.625MG
1.25MG
2.5MG

A084951
A084948
A084950
A084949

001

001

001

001

0.75MG
1.5MG
3MG
0.75MG
1.5MG
0.75MG
1.5MG
3MG

A040135
A040135
A040135
A040359
A040359
A081213
A081214
A081215

001
002
003
001
002
001
001
001

UPJOHN

0.75MG

A083220 001

UPJOHN

1.5MG

A083220 002

UPJOHN

3MG

A083220 003

UPJOHN

6MG

A083220 004

1MG
2MG
3MG
1MG
2MG
3MG
1MG
2MG
3MG
1MG
2MG
3MG
1MG
2MG
3MG
1MG

A091024
A091024
A091024
A091166
A091166
A091166
A091124
A091124
A091124
A202929
A202929
A202929
A091151
A091151
A091151
A091113

ESTROGENS, ESTERIFIED

TABLET;ORAL

MENEST

MONARCH PHARMS

+
ESTROPIPATE

TABLET;ORAL

ESTROPIPATE

AB
BARR
AB
AB
AB
MYLAN
AB
AB
WATSON LABS
AB
AB
OGEN .625

AB
PHARMACIA AND
OGEN 1.25

AB
PHARMACIA AND
OGEN 2.5

AB
+ PHARMACIA AND
OGEN 5

PHARMACIA AND

N020527 002 Nov 17, 1995

ESZOPICLONE

TABLET;ORAL

ESZOPICLONE

AB
DR REDDYS LABS LTD
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
LUPIN LTD
AB
AB
AB
MACLEODS PHARMS LTD
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
ORCHID HLTHCARE

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001

Jun
Mar
Nov
Jan

04,
12,
17,
09,

2003

2003

1995

1998

Nov
Nov
Nov
Aug
Aug
Sep
Sep
Sep

27,
27,
27,
26,
26,
23,
23,
23,

1996

1996

1996

1999

1999

1993

1993

1993

Apr
Apr
Apr
Apr
Apr
Apr
Sep
Sep
Sep
Jan
Jan
Jan
Mar
Mar
Mar
Jun

15,
15,
15,
15,
15,
15,
13,
13,
13,
30,
30,
30,
26,
26,
26,
10,

2014

2014

2014

2014

2014

2014

2011

2011

2011

2015

2015

2015

2013

2013

2013

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-146(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ESZOPICLONE

TABLET;ORAL

ESZOPICLONE

AB

AB

AB
ROXANE

AB

AB

AB
SUN PHARMA GLOBAL

AB

AB

AB
TEVA

AB

AB

LUNESTA

AB
SUNOVION PHARMS INC

AB

AB
+

ETHACRYNATE SODIUM

INJECTABLE;INJECTION

EDECRIN

AP
+ ATON

ETHACRYNATE SODIUM

AP
PAR STERILE PRODUCTS

ETHACRYNIC ACID

TABLET;ORAL

EDECRIN

+ ATON

ETHAMBUTOL HYDROCHLORIDE

TABLET;ORAL

ETHAMBUTOL HYDROCHLORIDE

AB
BARR

AB
LUPIN

AB

AB
VERSAPHARM INC

AB

MYAMBUTOL

AB
STI PHARMA LLC

AB
+

ETHANOLAMINE OLEATE

INJECTABLE;INJECTION

ETHAMOLIN

+ QOL MEDCL

2MG

3MG

1MG

2MG

3MG

1MG

2MG

3MG

1MG

2MG

3MG

A091113
A091113
A091153
A091153
A091153
A091103
A091103
A091103
A091169
A091169
A091169

1MG

2MG

3MG

N021476 001 Dec 15, 2004

N021476 002 Dec 15, 2004

N021476 003 Dec 15, 2004

EQ 50MG BASE/VIAL

N016093 001

EQ 50MG BASE/VIAL

A205473 001 Jul 29, 2015

25MG

N016092 001

400MG

100MG

400MG

100MG

400MG

A076057
A078939
A078939
A075095
A075095

100MG

400MG

N016320 001

N016320 003

50MG/ML

N019357 001 Dec 22, 1988

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

TABLET;ORAL-28

KELNOR
AB
BARR
0.035MG;1MG

ZOVIA 1/35E-28
AB
WATSON LABS
0.035MG;1MG

ZOVIA 1/50E-28
+ WATSON LABS
0.05MG;1MG

ETHINYL ESTRADIOL; ETONOGESTREL

RING;VAGINAL

NUVARING

+ ORGANON USA INC

0.015MG/24HR;0.12MG/24HR

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET;ORAL

ASHLYNA
AB
GLENMARK GENERICS
0.03MG,0.01MG;0.15MG,N/A
DAYSEE
AB
LUPIN LTD
0.03MG,0.01MG;0.15MG,N/A
INTROVALE
AB
SANDOZ
0.03MG;0.15MG
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB
GLENMARK GENERICS
0.02MG;0.09MG
AB
GLENMARK PHARMS LTD
0.03MG;0.15MG
AB
HAUPT PHARMA
0.03MG;0.15MG
AB
0.03MG,0.01MG;0.15MG,NA
AB
JAI PHARMA LTD
0.03MG;0.15MG

002
003
001
002
003
001
002
003
001
002
003

001
001
002
001
002

Jun
Jun
Apr
Apr
Apr
Apr
Apr
Apr
May
May
May

Nov
Jun
Jun
Nov
Nov

10,
10,
15,
15,
15,
03,
03,
03,
23,
23,
23,

26,
17,
17,
30,
30,

2014

2014

2014

2014

2014

2013

2013

2013

2011

2011

2011

2001

2009

2009

1999

1999

A076785 001 May 23, 2005

A072721 001 Dec 30, 1991

A072723 001 Dec 30, 1991

N021187 001 Oct 03, 2001

A203163 001 Feb 23, 2015

A091467 001 Apr 10, 2013

A079064 001 Sep 27, 2010

A202791
A203164
A203871
A203872
A200490

001
001
001
001
001

Apr
Jun
Nov
Dec
Apr

09,
12,
13,
22,
21,

2015

2015

2015

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-147(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET;ORAL

LEVONORGESTREL AND ETHINYL ESTRADIOL

AB
LUPIN LTD
0.02MG,0.01MG;0.1MG,N/A
AB
0.03MG;0.15MG
AB
+ WATSON LABS
0.02MG;0.09MG
AB
0.02MG,0.01MG;0.1MG,N/A
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

AB
JAI PHARMA LTD
0.02MG,0.01MG;0.1MG,N/A
AB
0.03MG,0.01MG;0.15MG,N/A
AB
WATSON LABS
0.03MG,0.01MG;0.15MG,N/A
LOSEASONIQUE

AB
TEVA BRANDED PHARM
0.01MG;0.02MG;0.1MG
QUASENSE

AB
WATSON LABS
0.03MG;0.15MG
SEASONALE

AB
+ TEVA BRANDED PHARM
0.03MG;0.15MG
SEASONIQUE

AB
+ TEVA BRANDED PHARM
0.03MG,0.01MG;0.03MG,0.01MG;0.15MG,N/A
SETLAKIN

AB
NOVAST LABS LTD
0.03MG;0.15MG
QUARTETTE

+ TEVA BRANDED PHARM
0.02MG;0.15MG
TABLET;ORAL-28

ALTAVERA

AB
SANDOZ
0.03MG;0.15MG
ELIFEMME

AB
SANDOZ INC
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG

ENPRESSE-28

AB
DURAMED PHARMS BARR
0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1
25MG

KURVELO

AB
LUPIN LTD
0.03MG;0.15MG
LEVONEST

AB
NOVAST LABS LTD
0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1
25MG

LEVONORGESTREL AND ETHINYL ESTRADIOL

AB
HAUPT PHARMA
0.03MG;0.15MG
AB
JAI PHARMA LTD
0.03MG;0.15MG
AB
LUPIN LTD
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG

LEVORA 0.15/30-28

AB
+ WATSON LABS
0.03MG;0.15MG
MARLISSA

AB
GLENMARK GENERICS
0.03MG;0.15MG
MYZILRA

AB
VINTAGE PHARMS LLC
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG

PORTIA-28

AB
BARR
0.03MG;0.15MG
TRIVORA-28

AB
+ WATSON LABS
0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1
25MG

AVIANE-28

AB1
DURAMED PHARMS BARR
0.02MG;0.1MG
FALMINA

AB1
NOVAST LABS LTD
0.02MG;0.1MG
LEVONORGESTREL AND ETHINYL ESTRADIOL

AB1
HAUPT PHARMA
0.02MG;0.1MG
AB1
JAI PHARMA LTD
0.02MG;0.1MG
AB1
LUPIN LTD
0.02MG;0.1MG
AB1 + WATSON LABS
0.02MG;0.1MG
ORSYTHIA

AB1
VINTAGE PHARMS LLC
0.02MG;0.1MG
VIENVA

AB1
SANDOZ INC
0.02MG;0.1MG
LESSINA-28

AB2
BARR
0.02MG;0.1MG
LEVONORGESTREL AND ETHINYL ESTRADIOL

AB2
JAI PHARMA LTD
0.02MG;0.1MG
AB2 + WATSON LABS
0.02MG;0.1MG

A091674
A091440
A079218
A200407

001
001
001
001

Oct
Oct
Jun
Oct

26,
23,
06,
25,

2011

2012

2011

2011

A200493 001 Jun 17, 2015

A200492 001 May 27, 2015

A078834 001 May 31, 2011

N022262 001 Oct 24, 2008

A077101 001 Sep 06, 2006

N021544 001 Sep 05, 2003

N021840 001 May 25, 2006

A090716 001 Sep 15, 2014

N204061 001 Mar 28, 2013

A079102 001 Aug 03, 2010

A202507 001 Dec 04, 2015

A075809 002 Jul 16, 2001

A091408 001 Oct 17, 2012

A090719 001 Dec 29, 2010

A201095 001 Dec 08, 2014

A091663 001 Dec 21, 2012

A200248 001 Nov 19, 2015

A073594 001 Dec 13, 1993

A091452 001 Feb 29, 2012

A077502 001 Nov 23, 2011

A075866 002 May 23, 2002

A074538 002 Dec 18, 1997

A075796 001 Apr 30, 2001

A090721 001 Mar 28, 2012

A201108
A200245
A091425
A076625

001
001
001
001

Feb
Oct
Jan
Nov

05,
09,
18,
18,

2014

2013

2013

2004

A077099 001 May 11, 2011

A201088 001 May 21, 2015

A075803 002 Mar 20, 2002

A202247 001 Dec 08, 2014

A077681 001 May 31, 2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-148(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORELGESTROMIN

FILM, EXTENDED RELEASE;TRANSDERMAL

XULANE

AB
+ MYLAN TECHNOLOGIES
0.035MG/24HR;0.15MG/24HR
ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-21

NORINYL 1+35 21-DAY

AB
ACTAVIS LABS UT INC
0.035MG;1MG
NORTREL 1/35-21

AB
BARR
0.035MG;1MG
NORTREL 7/7/7

BARR
0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M
G

TABLET;ORAL-28

ALYACEN 1/35

AB
GLENMARK GENERICS
0.035MG;1MG
ALYACEN 7/7/7

AB
GLENMARK GENERICS
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G

ARANELLE

AB
BARR
0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG
BALZIVA-28

AB
BARR
0.035MG;0.4MG
BREVICON 28-DAY

AB
ACTAVIS LABS UT INC
0.035MG;0.5MG
BRIELLYN

AB
GLENMARK GENERICS
0.035MG;0.4MG
CYCLAFEM 0.5/35

AB
VINTAGE PHARMS
0.035MG;0.5MG
CYCLAFEM 1/35

AB
VINTAGE PHARMS LLC
0.035MG;1MG
CYCLAFEM 7/7/7

AB
VINTAGE PHARMS LLC
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G

DASETTA 1/35

AB
NOVAST LABS LTD
0.035MG;1MG
DASETTA 7/7/7

AB
NOVAST LABS LTD
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G

GILDAGIA

AB
VINTAGE PHARMS
0.035MG;0.4MG
MODICON 28

AB
+ JANSSEN PHARMS
0.035MG;0.5MG
NORETHINDRONE AND ETHINYL ESTRADIOL

AB
+ JAI PHARMA LTD
0.035MG;0.4MG
AB
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G

AB
0.035MG;0.5MG
AB
0.035MG;1MG
AB
WATSON LABS
0.035MG;0.4MG
AB
0.035MG;0.5MG
AB
0.035MG;1MG
NORINYL 1+35 28-DAY

AB
ACTAVIS LABS UT INC
0.035MG;1MG
NORTREL 0.5/35-28

AB
BARR
0.035MG;0.5MG
NORTREL 1/35-28

AB
BARR
0.035MG;1MG
NORTREL 7/7/7

AB
BARR
0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M
G

ORTHO-NOVUM 1/35-28

AB
+ JANSSEN PHARMS
0.035MG;1MG
ORTHO-NOVUM 7/7/7-28

AB
+ JANSSEN PHARMS
0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M
G

PHILITH

AB
NOVAST LABS LTD
0.035MG;0.4MG
PIRMELLA 1/35

AB
LUPIN LTD
0.035MG;1MG
PIRMELLA 7/7/7

AB
LUPIN LTD
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G

A200910 001 Apr 16, 2014

N017565 001

A072693 001 Feb 28, 1992

A075478 001 Aug 30, 2002

A091634 001 Jan 19, 2012

A091636 001 Jan 19, 2012

A076783 001 Sep 29, 2004

A076238 001 Apr 22, 2004

N017743 001

A090538 001 Mar 22, 2011

A203413 001 Dec 16, 2015

A076337 001 Nov 12, 2010

A076338 001 Nov 16, 2010

A090948 001 Dec 22, 2011

A090946 001 Dec 22, 2011

A078376 001 Nov 06, 2012

N017735 001

A200897 001 May 11, 2015

A200486 001 Dec 28, 2015

A200488
A200489
A078323
A070686
A070687

001
001
001
001
001

Oct
Oct
Feb
Jan
Jan

21,
21,
04,
29,
29,

2015

2015

2010

1987

1987

N017565 002

A072695 001 Feb 28, 1992

A072696 001 Feb 28, 1992

A075478 002 Aug 30, 2002

N017919 002

N018985 002 Apr 04, 1984

A090947 001 Dec 22, 2011

A201512 001 Apr 24, 2013

A201510 001 Apr 24, 2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-149(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-28

TRI-NORINYL 28-DAY

AB
+ ACTAVIS LABS UT INC
0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG
VYFEMLA

AB
LUPIN LTD
0.035MG;0.4MG
WERA

AB
NOVAST LABS LTD
0.035MG;0.5MG
NORETHINDRONE AND ETHINYL ESTRADIOL

+ JAI PHARMA LTD
0.05MG;1MG
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)

WATSON LABS
0.035MG;0.035MG;0.5MG;1MG
TABLET, CHEWABLE;ORAL

FEMCON FE

AB
+ WARNER CHILCOTT LLC
0.035MG;0.4MG
KAITLIB FE

AB
LUPIN LTD
0.025MG;0.8MG
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

AB
AMNEAL PHARMS
0.035MG;0.4MG
AB
BARR
0.035MG;0.4MG
AB
JAI PHARMA LTD
0.025MG;0.8MG
AB
0.035MG;0.4MG
AB
+ WARNER CHILCOTT
0.025MG;0.8MG
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET;ORAL

BLISOVI 24 FE

AB
LUPIN LTD
0.02MG;1MG
FEMHRT

AB
WARNER CHILCOTT LLC
0.0025MG;0.5MG
FYAVOLV

AB
LUPIN LTD
0.005MG;1MG
AB
0.0025MG;0.5MG
GILDESS 24 FE

AB
VINTAGE PHARMS
0.02MG;1MG
LARIN 24 FE

AB
NOVAST LABS LTD
0.02MG;1MG
LOESTRIN 24 FE

AB
WARNER CHILCOTT
0.02MG;1MG
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

AB
+ BARR LABS INC
0.005MG;1MG
AB
GLENMARK GENERICS
0.0025MG;0.5MG
AB
0.005MG;1MG
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

AB
+ AMNEAL PHARMS
0.02MG;1MG
AB
BARR LABS INC
0.02MG;1MG
AB
JAI PHARMA LTD
0.02MG;1MG
LO LOESTRIN FE

+ WARNER CHILCOTT LLC
0.01MG,0.01MG;1MG,N/A
TABLET;ORAL-21

GILDESS 1.5/30

AB
VINTAGE PHARMS LLC
0.03MG;1.5MG
GILDESS 1/20

AB
VINTAGE PHARMS LLC
0.02MG;1MG
JUNEL 1.5/30

AB
BARR
0.03MG;1.5MG
JUNEL 1/20

AB
BARR
0.02MG;1MG
LARIN 1.5/30

AB
NOVAST LABS LTD
0.03MG;1.5MG
LARIN 1/20

AB
NOVAST LABS LTD
0.02MG;1MG
LOESTRIN 21 1.5/30

AB
WARNER CHILCOTT LLC
0.03MG;1.5MG
LOESTRIN 21 1/20

AB
WARNER CHILCOTT LLC
0.02MG;1MG
MICROGESTIN 1.5/30

AB
WATSON LABS
0.03MG;1.5MG
MICROGESTIN 1/20

AB
WATSON LABS
0.02MG;1MG
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

AB
JAI PHARMA LTD
0.02MG;1MG
AB
0.03MG;1.5MG

N018977 002 Apr 13, 1984

A201886 001 Sep 26, 2013

A091204 001 Mar 27, 2012

A203006 001 Aug 05, 2013

A071044 001 Apr 01, 1988

N021490 001 Nov 14, 2003

A203448 001 Dec 17, 2015

A078892
A078965
A203371
A202086
N022573

001
001
001
001
001

Sep
Aug
Apr
Apr
Dec

26,
05,
23,
01,
22,

2011

2010

2014

2015

2010

A091398 001 Oct 28, 2015

N021065 001 Jan 14, 2005

A204213 002 Dec 10, 2015

A204213 001 Dec 10, 2015

A090293 001 Dec 01, 2014

A202994 001 Feb 18, 2015

N021871 001 Feb 17, 2006

A076221 001 Nov 06, 2009

A203038 001 Apr 02, 2015

A203038 002 Apr 02, 2015

A078267 001 Sep 01, 2009

A090938 001 Dec 01, 2014

A202742 001 Oct 30, 2014

N022501 001 Oct 21, 2010

A077075 002 Jul 24, 2012

A077077 002 Jul 24, 2012

A076381 001 May 30, 2003

A076380 001 May 30, 2003

A202996 001 Mar 20, 2014

A202995 001 Dec 04, 2013

N017875 001

N017876 001

A075548 002 Jul 30, 2003

A075647 002 Jul 30, 2003

A202771 001 Nov 06, 2013

A202770 001 Feb 19, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET;ORAL-21

TRI-LEGEST 21

BARR
0.02MG;0.035MG;0.03MG;1MG;1MG;1MG
TABLET;ORAL-28

BLISOVI FE 1.5/30

AB
LUPIN LTD
0.03MG;1.5MG
BLISOVI FE 1/20

AB
LUPIN LTD
0.02MG;1MG
ESTROSTEP FE

AB
+ WARNER CHILCOTT LLC
0.02MG;0.035MG;0.03MG;1MG;1MG;1MG
GILDESS FE 1.5/30

AB
VINTAGE PHARMS LLC
0.03MG;1.5MG
GILDESS FE 1/20

AB
VINTAGE PHARMS LLC
0.02MG;1MG
JUNEL FE 1.5/30

AB
BARR
0.03MG;1.5MG
JUNEL FE 1/20

AB
BARR
0.02MG;1MG
LARIN FE 1.5/30

AB
NOVAST LABS LTD
0.03MG;1.5MG
LARIN FE 1/20

AB
NOVAST LABS LTD
0.02MG;1MG
LOESTRIN FE 1.5/30

AB
+ WARNER CHILCOTT LLC
0.03MG;1.5MG
LOESTRIN FE 1/20

AB
WARNER CHILCOTT
0.02MG;1MG
MICROGESTIN FE 1.5/30

AB
WATSON LABS
0.03MG;1.5MG
MICROGESTIN FE 1/20

AB
WATSON LABS
0.02MG;1MG
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

AB
JAI PHARMA LTD
0.02MG;1MG
AB
0.03MG;1.5MG
AB
WATSON LABS
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
TRI-LEGEST FE

AB
BARR
0.02MG;0.035MG;0.03MG;1MG;1MG;1MG
TABLET, CHEWABLE;ORAL

MINASTRIN 24 FE

+ WARNER CHILCOTT LLC
0.02MG;1MG
TABLET, CHEWABLE, TABLET;ORAL

LO MINASTRIN FE

+ WARNER CHILCOTT
0.01MG,0.01MG,N/A;1MG,N/A,N/A
ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL

NORGESTIMATE AND ETHINYL ESTRADIOL

AB
GLENMARK GENERICS
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
0.25MG

TABLET;ORAL-28

ESTARYLLA

AB
SANDOZ
0.035MG;0.25MG
MONO-LINYAH

AB
NOVAST LABS LTD
0.035MG;0.25MG
NORGESTIMATE AND ETHINYL ESTRADIOL

AB
GLENMARK GENERICS
0.035MG;0.25MG
AB
HAUPT PHARMA
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
0.25MG

AB
0.035MG;0.25MG
AB
JAI PHARMA LTD
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,
0.25MG

AB
LUPIN PHARMS
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,
0.25MG

AB
OC PHARMA
0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;
0.25MG

AB
0.035MG;0.25MG
ORTHO CYCLEN-28

AB
+ JANSSEN PHARMS
0.035MG;0.25MG
ORTHO TRI-CYCLEN

AB
+ JANSSEN PHARMS
0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;
0.25MG

ORTHO TRI-CYCLEN LO

AB
+ JANSSEN PHARMS
0.025MG;0.025MG;0.025MG;0.18MG;0.215MG;
0.25MG

3-150(of 388)

A076405 001 Oct 26, 2007

A201585 001 Nov 18, 2015

A201584 001 Nov 18, 2015

N020130 002 Oct 09, 1996

A077075 001 Apr 28, 2005

A077077 001 May 20, 2005

A076064 001 Sep 18, 2003

A076081 001 Sep 18, 2003

A091453 001 Aug 23, 2013

A091454 001 Aug 26, 2013

N017355 001

N017354 001

A075548 001 Feb 05, 2001

A075647 001 Feb 05, 2001

A202772 001 Nov 14, 2013

A202741 001 Feb 20, 2015

A076629 001 Mar 18, 2010

A076105 001 Oct 26, 2007

N203667 001 May 08, 2013

N204654 001 Jul 24, 2013

A200494 001 Jun 17, 2011

A090794 001 Jan 30, 2013

A090523 001 May 23, 2012

A200538 001 Apr 05, 2012

A203870 001 Nov 12, 2015

A203865 001 Oct 27, 2015

A202132 001 Sep 09, 2015

A200541 001 Jun 25, 2012

A200383 001 Apr 07, 2015

A200384 001 Apr 07, 2015

N019653 002 Dec 29, 1989

N019697 001 Jul 03, 1992

N021241 001 Aug 22, 2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL-28

PREVIFEM
AB
VINTAGE PHARMS LLC
0.035MG;0.25MG

SPRINTEC
AB
BARR
0.035MG;0.25MG

TRI LO SPRINTEC
AB
BARR LABS INC
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,

0.25MG

TRI-ESTARYLLA
AB
SANDOZ
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,

0.25MG

TRI-LINYAH
AB
NOVAST LABS LTD
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,

0.25MG

TRI-LO-ESTARYLLA
AB
SANDOZ INC
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,

0.25MG

TRI-PREVIFEM
AB
VINTAGE PHARMS LLC
0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;

0.25MG

TRI-SPRINTEC
AB
BARR
0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;

0.25MG

ETHINYL ESTRADIOL; NORGESTREL

TABLET;ORAL-21

CRYSELLE

AB
DURAMED PHARMS BARR

TABLET;ORAL-28

CRYSELLE

AB
DURAMED PHARMS BARR

ELINEST

AB
NOVAST LABS LTD

LO/OVRAL-28

AB
WYETH PHARMS

LOW-OGESTREL-28

AB
WATSON LABS

OGESTREL 0.5/50-28

+ WATSON LABS

3-151(of 388)

A076334 001 Jan 09, 2004

A075804 001 Sep 25, 2002

A076784 001 Jun 29, 2009

A090793 001 Jan 30, 2013

A090524 001 May 30, 2012

A091232 001 Jun 29, 2015

A076335 001 Mar 26, 2004

A075808 001 Dec 29, 2003

0.03MG;0.3MG

A075840 001 Nov 30, 2001

0.03MG;0.3MG

A075840 002 Nov 30, 2001

0.03MG;0.3MG

A091105 001 Mar 28, 2012

0.03MG;0.3MG

N017802 001

0.03MG;0.3MG

A075288 002 Jul 28, 1999

0.05MG;0.5MG

A075406 002 Dec 15, 1999

ETHIODIZED OIL

OIL;INTRALYMPHATIC, INTRAUTERINE

LIPIODOL

+ GUERBET

99%

N009190 001

ETHIONAMIDE

TABLET;ORAL

TRECATOR

+ WYETH PHARMS INC

250MG

N013026 002

250MG

250MG

250MG

A040430 001 Oct 28, 2002

A200892 001 Sep 25, 2012

A040686 001 May 28, 2008

250MG

N012380 001

250MG/5ML

250MG/5ML

250MG/5ML

A040506 001 Dec 22, 2003

A040253 001 Nov 22, 2000

A081306 001 Jul 30, 1993

250MG/5ML

A080258 001

250MG

N010841 001

ETHOSUXIMIDE

CAPSULE;ORAL

ETHOSUXIMIDE
AB
BANNER LIFE SCIENCES
AB
HERITAGE PHARMS INC
AB
VERSAPHARM
ZARONTIN
AB
+ PARKE DAVIS
SYRUP;ORAL

ETHOSUXIMIDE

AA
MIKART

AA
PHARM ASSOC

AA
TEVA PHARMS

ZARONTIN

AA
+ PARKE DAVIS

ETHOTOIN

TABLET;ORAL

PEGANONE

+ RECORDATI RARE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-152(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ETIDRONATE DISODIUM

TABLET;ORAL

DIDRONEL

AB
PROCTER AND GAMBLE

AB
+

ETIDRONATE DISODIUM

AB
MYLAN

AB

200MG

400MG

N017831 001

N017831 002

200MG

400MG

A075800 001 Jan 24, 2003

A075800 002 Jan 24, 2003

ETODOLAC

CAPSULE;ORAL

ETODOLAC

AB
ANI PHARMS INC

200MG

AB

300MG

AB
APOTEX

200MG

AB

300MG

AB
TARO

200MG

AB
+

300MG

TABLET;ORAL

ETODOLAC

AB
APOTEX INC
400MG

AB
500MG

AB
MYLAN
400MG

AB
500MG

AB
SANDOZ
400MG

AB
500MG

AB
TARO PHARM INDS
400MG

AB
+
500MG

AB
TEVA
400MG

AB
500MG

TABLET, EXTENDED RELEASE;ORAL

ETODOLAC

AB
TARO

400MG

AB

500MG

AB

600MG

AB
TEVA

400MG

AB

500MG

AB
+

600MG

AB
ZYDUS PHARMS USA INC
400MG

AB

500MG

AB

600MG

ETOMIDATE

INJECTABLE;INJECTION

AMIDATE

AP
+ HOSPIRA

ETOMIDATE

AP
BEDFORD

AP
EMCURE PHARMS LTD

AP
LUITPOLD

AP
MYLAN LABS LTD

AP
PAR STERILE PRODUCTS

AP
ZYDUS PHARMS USA INC

ETONOGESTREL

IMPLANT;IMPLANTATION

NEXPLANON

+ ORGANON USA INC

ETOPOSIDE

CAPSULE;ORAL

ETOPOSIDE

+ MYLAN

INJECTABLE;INJECTION

ETOPOSIDE

AP
ACCORD HLTHCARE

AP
EUROHLTH INTL SARL

AP
+ FRESENIUS KABI USA

AP
TEVA PHARMS USA

A075126
A075126
A075419
A075419
A075078
A075078

001
002
001
002
001
002

Sep
Sep
Jul
Jul
Apr
Apr

16,
16,
28,
28,
30,
30,

1999

1999

2000

2000

1998

1998

A076004
A076004
A075104
A075104
A074903
A074903
A075074
A075074
A075009
A075009

001
002
001
002
001
002
001
002
001
002

Dec
Dec
Feb
Nov
Apr
Apr
Mar
Apr
Nov
Dec

03,
03,
06,
20,
11,
19,
11,
25,
26,
28,

2002

2002

1998

1998

1997

1999

1998

2000

1997

1999

A076174
A076174
A076174
A075665
A075665
A075665
A091134
A091134
A091134

001
002
003
003
002
001
001
002
003

Mar
Mar
Mar
Feb
Jul
Jul
Jan
Jan
Jan

13,
13,
13,
05,
31,
31,
23,
23,
23,

2003

2003

2003

2001

2000

2000

2014

2014

2014

2MG/ML

N018227 001 Sep 07, 1982

2MG/ML

2MG/ML

2MG/ML

2MG/ML

2MG/ML

2MG/ML

A074593
A204618
A078867
A078289
A091297
A202360

68MG/IMPLANT

N021529 002 May 31, 2011

50MG

A075635 001 Sep 19, 2001

20MG/ML

20MG/ML

20MG/ML

20MG/ML

A074513
A074290
A074983
A074529

001
001
001
001
001
001

001
001
001
001

Nov
Aug
Dec
Jan
Jun
Jul

Mar
Jul
Sep
Jul

04,
13,
22,
02,
20,
18,

14,
17,
30,
24,

1996

2014

2009

2009

2012

2014

1996

1995

1998

1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-153(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ETOPOSIDE PHOSPHATE

INJECTABLE;INJECTION

ETOPOPHOS PRESERVATIVE FREE

+ BRISTOL MYERS SQUIBB
EQ 100MG BASE/VIAL
ETRAVIRINE

TABLET;ORAL

INTELENCE

JANSSEN R AND D
+
EVEROLIMUS

TABLET;ORAL

AFINITOR

NOVARTIS

+
ZORTRESS

NOVARTIS
+
TABLET, FOR SUSPENSION;ORAL

AFINITOR DISPERZ

NOVARTIS PHARM
+
EXEMESTANE

TABLET;ORAL

AROMASIN

AB
+ PHARMACIA AND UPJOHN
EXEMESTANE

AB
ALVOGEN INC
AB
ROXANE

N020457 001 May 17, 1996

25MG
100MG
200MG

N022187 003 Mar 26, 2012

N022187 001 Jan 18, 2008
N022187 002 Dec 22, 2010

2.5MG
5MG
7.5MG
10MG

N022334
N022334
N022334
N022334

0.25MG
0.5MG
0.75MG

N021560 001 Apr 20, 2010

N021560 002 Apr 20, 2010

N021560 003 Apr 20, 2010

2MG
3MG
5MG

N203985 001 Aug 29, 2012

N203985 002 Aug 29, 2012

N203985 003 Aug 29, 2012

25MG

N020753 001 Oct 21, 1999

25MG
25MG

A200898 001 Jul 28, 2014

A077431 001 Apr 01, 2011

003
001
004
002

Jul
Mar
Mar
Mar

09,
30,
30,
30,

2010

2009

2012

2009

EXENATIDE SYNTHETIC

FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

BYDUREON

+ ASTRAZENECA AB
2MG/VIAL
INJECTABLE;SUBCUTANEOUS

BYETTA

+ ASTRAZENECA AB
300MCG/1.2ML (250MCG/ML)
+
600MCG/2.4ML (250MCG/ML)

N021773 001 Apr 28, 2005

N021773 002 Apr 28, 2005

EZETIMIBE

TABLET;ORAL

ZETIA

+ MSD INTL GMBH

10MG

N021445 001 Oct 25, 2002

10MG;10MG
10MG;20MG
10MG;40MG
10MG;80MG

N021687
N021687
N021687
N021687

001
002
003
004

Jul
Jul
Jul
Jul

23,
23,
23,
23,

2004

2004

2004

2004

50MG
200MG
300MG
400MG

N022345
N022345
N022345
N022345

001
002
003
004

Jun
Jun
Jun
Jun

10,
10,
10,
10,

2011

2011

2011

2011

125MG
250MG
500MG
125MG
250MG
500MG

A091480
A091480
A091480
A091114
A091114
A091114

001
002
003
001
002
003

Jul
Jul
Jul
Mar
Mar
Mar

22,
22,
22,
21,
21,
21,

2011

2011

2011

2011

2011

2011

EZETIMIBE; SIMVASTATIN

TABLET;ORAL

VYTORIN

MSD INTL

+
EZOGABINE

TABLET;ORAL

POTIGA

GLAXOSMITHKLINE

+
FAMCICLOVIR

TABLET;ORAL

FAMCICLOVIR

AB
APOTEX
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB

N022200 001 Jan 27, 2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-154(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FAMCICLOVIR

TABLET;ORAL

FAMCICLOVIR

AB
CIPLA LTD

AB

AB

AB
HETERO LABS LTD V

AB

AB

AB
MACLEODS PHARMS LTD

AB

AB

AB
MYLAN

AB

AB

AB
ROXANE

AB

AB

AB
TEVA PHARMS

AB

AB

FAMVIR

AB
NOVARTIS

AB

AB
+

125MG

250MG

500MG

125MG

250MG

500MG

125MG

250MG

500MG

125MG

250MG

500MG

125MG

250MG

500MG

125MG

250MG

500MG

A078278
A078278
A078278
A202438
A202438
A202438
A201022
A201022
A201022
A201333
A201333
A201333
A090128
A090128
A090128
A077487
A077487
A077487

125MG

250MG

500MG

N020363 003 Dec 11, 1995

N020363 001 Apr 26, 1996

N020363 002 Jun 29, 1994

FAMOTIDINE

FOR SUSPENSION;ORAL

FAMOTIDINE

AB
HI-TECH PHARMA CO

40MG/5ML

AB
LUPIN LTD

40MG/5ML

AB
NAVINTA LLC

40MG/5ML

PEPCID

AB
+ SALIX PHARMS

40MG/5ML

INJECTABLE;INJECTION

FAMOTIDINE

AP
BEDFORD

10MG/ML

AP

10MG/ML

AP
+ EUROHLTH INTL SARL

10MG/ML

AP
FRESENIUS KABI USA

10MG/ML

AP
MYLAN LABS LTD

10MG/ML

FAMOTIDINE PRESERVATIVE FREE

AP
BEDFORD
10MG/ML

AP
BEDFORD LABS
10MG/ML

AP
+ EUROHLTH INTL SARL
10MG/ML

AP
FRESENIUS KABI USA
10MG/ML

AP
MYLAN LABS LTD
10MG/ML

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE

0.4MG/ML

SUSPENSION;ORAL

FAMOTIDINE

AB
NOVEL LABS INC

40MG/5ML

TABLET;ORAL

FAMOTIDINE
AB
ALEMBIC PHARMS LTD
20MG

AB
40MG

AB
APOTEX
20MG

AB
40MG

AB
AUROBINDO PHARMA LTD
20MG

AB
40MG

AB
CARLSBAD
20MG

AB
40MG

AB
DR REDDYS LABS LTD
20MG

AB
40MG

AB
IVAX SUB TEVA PHARMS
20MG

AB
40MG

AB
MYLAN
20MG

AB
40MG

AB
PERRIGO
20MG

AB
40MG

AB
TEVA
20MG

AB
40MG

AB
WOCKHARDT
20MG

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Mar
Mar
Mar
Sep
Sep
Sep
Jan
Jan
Jan
Mar
Mar
Mar
Mar
Mar
Mar
Aug
Aug
Aug

21,
21,
21,
10,
10,
10,
12,
12,
12,
24,
24,
24,
21,
21,
21,
24,
24,
24,

2011

2011

2011

2014

2014

2014

2012

2012

2012

2011

2011

2011

2011

2011

2011

2007

2007

2007

A201995 001 May 30, 2014

A090440 001 Jun 29, 2010

A091020 001 May 27, 2010

N019527 001 Feb 02, 1987

A075651
A075684
A075488
A075709
A078641

001
001
001
001
001

Apr
Apr
Apr
Apr
Jun

16,
16,
16,
16,
25,

2001

2001

2001

2001

2008

A075622
A075825
A075486
A075813
A078642

001
001
001
001
001

Apr
Apr
Apr
Apr
Jun

16,
17,
16,
16,
25,

2001

2001

2001

2001

2008

A075591 001 May 10, 2001

A201695 001 Dec 17, 2012

A078916
A078916
A075611
A075611
A206530
A206530
A075805
A075805
A075718
A075718
A075511
A075511
A075704
A075704
A077352
A077352
A075311
A075311
A075786

001
002
001
002
001
002
001
002
001
002
001
002
001
002
002
001
001
002
001

May
May
Jul
Jul
Dec
Dec
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
Apr
Apr
Apr

22,
22,
23,
23,
22,
22,
16,
16,
16,
16,
16,
16,
16,
16,
27,
27,
16,
16,
16,

2009

2009

2001

2001

2015

2015

2001

2001

2001

2001

2001

2001

2001

2001

2005

2005

2001

2001

2001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-155(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FAMOTIDINE

TABLET;ORAL

FAMOTIDINE

AB

PEPCID

AB
VALEANT PHARMS NORTH

AB
+

40MG

A075786 002 Apr 16, 2001

20MG

40MG

N019462 001 Oct 15, 1986

N019462 002 Oct 15, 1986

FAMOTIDINE; IBUPROFEN

TABLET;ORAL

DUEXIS

+ HORIZON PHARMA

26.6MG;800MG

N022519 001 Apr 23, 2011

FEBUXOSTAT

TABLET;ORAL

ULORIC

TAKEDA PHARMS USA

+

40MG

80MG

N021856 001 Feb 13, 2009

N021856 002 Feb 13, 2009

600MG/5ML

A202385 001 Dec 16, 2011

600MG/5ML

N020189 003 Jul 29, 1993

400MG

600MG

400MG

600MG

400MG

600MG

A201680
A201680
A202284
A202284
A204595
A204595

400MG

600MG

N020189 001 Jul 29, 1993

N020189 002 Jul 29, 1993

FELBAMATE

SUSPENSION;ORAL

FELBAMATE

AB
AMNEAL PHARMS

FELBATOL

AB
+ MEDA PHARMS

TABLET;ORAL

FELBAMATE

AB
AMNEAL PHARMS

AB

AB
COREPHARMA

AB

AB
MYLAN PHARMS INC

AB

FELBATOL

AB
MEDA PHARMS

AB
+

001
002
001
002
001
002

Sep
Sep
Nov
Nov
Jan
Jan

13,
13,
04,
04,
11,
11,

2011

2011

2015

2015

2016

2016

FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

FELODIPINE

AB
AUROBINDO PHARMA LTD
2.5MG

AB
5MG

AB
10MG

AB
GLENMARK GENERICS
2.5MG

AB
5MG

AB
10MG

AB
HERITAGE PHARMS INC
2.5MG

AB
5MG

AB
10MG

AB
MUTUAL PHARM
2.5MG

AB
5MG

AB
10MG

AB
MYLAN
2.5MG

AB
5MG

AB
+
10MG

AB
ORCHID HLTHCARE
2.5MG

AB
5MG

AB
10MG

AB
SUN PHARM INDS LTD
2.5MG

AB
5MG

AB
10MG

AB
TORRENT PHARMS LTD
2.5MG

AB
5MG

AB
10MG

AB
VINTAGE PHARMS LLC
2.5MG

AB
5MG

AB
10MG

A203417
A203417
A203417
A090365
A090365
A090365
A201964
A201964
A201964
A075896
A075896
A075896
A078855
A078855
A078855
A203032
A203032
A203032
A091200
A091200
A091200
A202170
A202170
A202170
A200815
A200815
A200815

FENOFIBRATE

CAPSULE;ORAL

ANTARA (MICRONIZED)

AB
LUPIN ATLANTIS

AB
+

N021695 001 Nov 30, 2004

N021695 003 Nov 30, 2004

43MG

130MG

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jan
Jan
Jan
Dec
Dec
Dec
Nov
Nov
Nov
Nov
Nov
Nov
Apr
Apr
Apr
May
May
May
Dec
Dec
Dec
Nov
Nov
Nov
Oct
Oct
Oct

17,
17,
17,
17,
17,
17,
08,
08,
08,
02,
02,
02,
17,
17,
17,
21,
21,
21,
13,
13,
13,
28,
28,
28,
28,
28,
28,

2013

2013

2013

2010

2010

2010

2013

2013

2013

2004

2004

2004

2008

2008

2008

2015

2015

2015

2013

2013

2013

2011

2011

2011

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-156(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FENOFIBRATE

CAPSULE;ORAL

FENOFIBRATE

AB
SUN PHARM INDS LTD
AB
FENOFIBRATE (MICRONIZED)

AB
APOTEX INC
AB
AB
DR REDDYS LABS SA
AB
AB
IMPAX LABS
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
AB
TEVA
AB
AB
+
ANTARA (MICRONIZED)

LUPIN ATLANTIS
LIPOFEN

CIPHER PHARMS INC
+
TABLET;ORAL

FENOFIBRATE

AB
IMPAX LABS
AB
AB
LUPIN LTD
AB
AB
AB
AB
MYLAN
AB
AB
MYLAN PHARMS INC
AB
AB
SUN PHARM INDS LTD
AB
AB
TEVA
AB
+
AB
VALEANT PHARMS NORTH
AB
TRICOR

AB
ABBVIE
AB
+
TRIGLIDE

BX
+ SKYEPHARMA AG
FENOFIBRATE

SUN PHARM INDS LTD
FENOGLIDE

SANTARUS INC
+
FENOFIBRIC ACID

TABLET;ORAL

FIBRICOR

TRIBUTE PHARMS INTL
+
FENOLDOPAM MESYLATE

INJECTABLE;INJECTION

CORLOPAM

AP
+ HOSPIRA
FENOLDOPAM MESYLATE

AP
EUROHLTH INTL SARL
AP
SANDOZ

43MG
130MG

A201748 001 Oct 31, 2014

A201748 002 Oct 31, 2014

43MG
130MG
43MG
130MG
67MG
134MG
200MG
43MG
67MG
130MG
134MG
200MG
67MG
134MG
200MG

A202252
A202252
A090859
A090859
A075868
A075868
A075868
A202579
A202676
A202579
A202676
A202676
A075753
A075753
A075753

30MG
90MG

N021695 004 Oct 18, 2013

N021695 005 Oct 18, 2013

50MG
150MG

N021612 001 Jan 11, 2006

N021612 003 Jan 11, 2006

54MG
160MG
48MG
54MG
145MG
160MG
54MG
160MG
48MG
145MG
54MG
160MG
54MG
160MG
48MG
145MG

A076509
A076509
A090856
A204019
A090856
A204019
A076520
A076520
A202856
A202856
A076635
A076635
A076433
A076433
A090715
A090715

48MG
145MG

N021656 001 Nov 05, 2004

N021656 002 Nov 05, 2004

160MG

N021350 002 May 07, 2005

107MG

A076635 002 Oct 31, 2005

40MG
120MG

N022118 001 Aug 10, 2007

N022118 002 Aug 10, 2007

35MG
105MG

N022418 001 Aug 14, 2009

N022418 002 Aug 14, 2009

EQ 10MG BASE/ML

N019922 001 Sep 23, 1997

EQ 10MG BASE/ML
EQ 10MG BASE/ML

A076582 001 Oct 12, 2004

A077155 001 Feb 15, 2005

001
002
001
002
001
002
003
001
001
002
002
003
001
002
003

001
002
001
001
002
002
001
003
001
002
001
003
001
002
001
002

Jul
Jul
Mar
Mar
Oct
Oct
Oct
Jan
Oct
Jan
Oct
Oct
Sep
Apr
Apr

Mar
Mar
Dec
Aug
Dec
Aug
Oct
Oct
Dec
Dec
Oct
Oct
May
May
Apr
Apr

26,
26,
01,
01,
27,
27,
27,
10,
23,
10,
23,
23,
03,
09,
09,

26,
26,
23,
17,
23,
17,
25,
25,
07,
07,
31,
31,
13,
13,
05,
05,

2013

2013

2012

2012

2003

2003

2003

2013

2012

2013

2012

2012

2002

2002

2002

2008

2008

2011

2015

2011

2015

2007

2007

2012

2012

2005

2005

2005

2005

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-157(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FENOPROFEN CALCIUM

CAPSULE;ORAL

NALFON

+ XSPIRE

TABLET;ORAL

FENOPROFEN CALCIUM

+ MYLAN PHARMS INC

EQ 200MG BASE

EQ 400MG BASE

N017604 003

N017604 004 Jul 21, 2009

EQ 600MG BASE

A072267 001 Aug 17, 1988

FENTANYL

FILM, EXTENDED RELEASE;TRANSDERMAL

DURAGESIC-100
AB
JANSSEN PHARMS
100MCG/HR

DURAGESIC-12
AB
JANSSEN PHARMS
12.5MCG/HR

DURAGESIC-25
AB
+ JANSSEN PHARMS
25MCG/HR

DURAGESIC-50
AB
JANSSEN PHARMS
50MCG/HR

DURAGESIC-75
AB
JANSSEN PHARMS
75MCG/HR

FENTANYL-100
AB
ACTAVIS LABS UT INC
100MCG/HR

AB
AVEVA
100MCG/HR

AB
LAVIPHARM LABS
100MCG/HR

AB
MALLINCKRODT INC
100MCG/HR

AB
MYLAN TECHNOLOGIES
100MCG/HR

AB
PAR PHARM INC
100MCG/HR

FENTANYL-12
AB
MALLINCKRODT INC
12.5MCG/HR

AB
MYLAN TECHNOLOGIES
12.5MCG/HR

FENTANYL-25
AB
ACTAVIS LABS UT INC
25MCG/HR

AB
AVEVA
25MCG/HR

AB
LAVIPHARM LABS
25MCG/HR

AB
MALLINCKRODT INC
25MCG/HR

AB
MYLAN TECHNOLOGIES
25MCG/HR

AB
PAR PHARM INC
25MCG/HR

FENTANYL-50
AB
ACTAVIS LABS UT INC
50MCG/HR

AB
AVEVA
50MCG/HR

AB
LAVIPHARM LABS
50MCG/HR

AB
MALLINCKRODT INC
50MCG/HR

AB
MYLAN TECHNOLOGIES
50MCG/HR

AB
PAR PHARM INC
50MCG/HR

FENTANYL-75
AB
ACTAVIS LABS UT INC
75MCG/HR

AB
AVEVA
75MCG/HR

AB
LAVIPHARM LABS
75MCG/HR

AB
MALLINCKRODT INC
75MCG/HR

AB
MYLAN TECHNOLOGIES
75MCG/HR

AB
PAR PHARM INC
75MCG/HR

FENTANYL-37
MYLAN TECHNOLOGIES
37.5MCG/HR

FENTANYL-62
MYLAN TECHNOLOGIES
62.5MCG/HR

FENTANYL-87
MYLAN TECHNOLOGIES
87.5MCG/HR

SPRAY;SUBLINGUAL

SUBSYS

INSYS THERAP

0.1MG

0.2MG

+

0.4MG

0.6MG

0.8MG

1.2MG

1.6MG

N019813 001 Aug 07, 1990

N019813 005 Feb 04, 2005

N019813 004 Aug 07, 1990

N019813 003 Aug 07, 1990

N019813 002 Aug 07, 1990

A076709
A077449
A077051
A077154
A076258
A077062

004
004
004
004
004
004

Aug
Oct
Aug
Feb
Jan
Aug

20,
20,
04,
09,
28,
20,

2007

2008

2006

2011

2005

2007

A077154 005 Jun 11, 2015

A076258 005 Jan 23, 2007

A076709
A077449
A077051
A077154
A076258
A077062

001
001
001
001
001
001

Aug
Oct
Aug
Feb
Jan
Aug

20,
20,
04,
09,
28,
20,

2007

2008

2006

2011

2005

2007

A076709
A077449
A077051
A077154
A076258
A077062

002
002
002
002
002
002

Aug
Oct
Aug
Feb
Jan
Aug

20,
20,
04,
09,
28,
20,

2007

2008

2006

2011

2005

2007

A076709
A077449
A077051
A077154
A076258
A077062

003
003
003
003
003
003

Aug
Oct
Aug
Feb
Jan
Aug

20,
20,
04,
09,
28,
20,

2007

2008

2006

2011

2005

2007

A076258 006 Dec 29, 2014

A076258 007 Dec 29, 2014

A076258 008 Dec 29, 2014

N202788
N202788
N202788
N202788
N202788
N202788
N202788

001
002
003
004
005
006
007

Jan
Jan
Jan
Jan
Jan
Aug
Aug

04,
04,
04,
04,
04,
30,
30,

2012

2012

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-158(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FENTANYL CITRATE

INJECTABLE;INJECTION

FENTANYL CITRATE

AP
HOSPIRA
EQ 0.05MG BASE/ML
FENTANYL CITRATE PRESERVATIVE FREE

AP
+ EUROHLTH INTL SARL
EQ 0.05MG BASE/ML
AP
HOSPIRA
EQ 0.05MG BASE/ML
SUBLIMAZE PRESERVATIVE FREE

AP
+ AKORN
EQ 0.05MG BASE/ML
SPRAY, METERED;NASAL

LAZANDA

DEPOMED INC
EQ 0.1MG BASE
EQ 0.3MG BASE
+
EQ 0.4MG BASE
TABLET;BUCCAL, SUBLINGUAL

FENTORA

CEPHALON
EQ 0.1MG BASE
EQ 0.2MG BASE
+
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
TABLET;SUBLINGUAL

ABSTRAL

SENTYNL THERAPS INC
EQ 0.1MG BASE
EQ 0.2MG BASE
EQ 0.3MG BASE
+
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL

ACTIQ

AB
CEPHALON
EQ 0.2MG BASE
AB
+
EQ 0.4MG BASE
AB
EQ 0.6MG BASE
AB
EQ 0.8MG BASE
AB
EQ 1.2MG BASE
AB
EQ 1.6MG BASE
FENTANYL CITRATE

AB
MALLINCKRODT
EQ 0.2MG BASE
AB
EQ 0.4MG BASE
AB
EQ 0.6MG BASE
AB
EQ 0.8MG BASE
AB
EQ 1.2MG BASE
AB
EQ 1.6MG BASE
AB
PAR PHARM
EQ 0.2MG BASE
AB
EQ 0.4MG BASE
AB
EQ 0.6MG BASE
AB
EQ 0.8MG BASE
AB
EQ 1.2MG BASE
AB
EQ 1.6MG BASE
FENTANYL HYDROCHLORIDE

SYSTEM;IONTOPHORESIS, TRANSDERMAL

IONSYS

+ THE MEDICINES CO
EQ 40MCG BASE/ACTIVATION

N021338 001 May 22, 2006

FERRIC CARBOXYMALTOSE

INJECTABLE;INTRAVENOUS

INJECTAFER

+ LUITPOLD

750MG IRON/15ML (50MG IRON/ML)

N203565 001 Jul 25, 2013

FERRIC CITRATE

TABLET;ORAL

AURYXIA

+ KERYX BIOPHARMS

EQ 210MG IRON

N205874 001 Sep 05, 2014

FERRIC HEXACYANOFERRATE(II)

CAPSULE;ORAL

RADIOGARDASE (PRUSSIAN BLUE)

+ HEYL CHEMISCH
500MG

N019115 001 Jan 12, 1985

N019101 001 Jul 11, 1984

A072786 001 Sep 24, 1991

N016619 001

N022569 001 Jun 30, 2011

N022569 003 Dec 21, 2015

N022569 002 Jun 30, 2011

N021947
N021947
N021947
N021947
N021947

001
002
003
004
005

Sep
Sep
Sep
Sep
Sep

25,
25,
25,
25,
25,

2006

2006

2006

2006

2006

N022510
N022510
N022510
N022510
N022510
N022510

001
002
003
004
005
006

Jan
Jan
Jan
Jan
Jan
Jan

07,
07,
07,
07,
07,
07,

2011

2011

2011

2011

2011

2011

N020747
N020747
N020747
N020747
N020747
N020747

001
002
003
004
005
006

Nov
Nov
Nov
Nov
Nov
Nov

04,
04,
04,
04,
04,
04,

1998

1998

1998

1998

1998

1998

A078907
A078907
A078907
A078907
A078907
A078907
A077312
A077312
A077312
A077312
A077312
A077312

001
002
003
004
005
006
001
002
003
004
005
006

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

N021626 001 Oct 02, 2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-159(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FERRIC PYROPHOSPHATE CITRATE

SOLUTION;IV (INFUSION)

TRIFERIC

+ ROCKWELL MEDICAL INC

FERUMOXYTOL

SOLUTION;INTRAVENOUS

FERAHEME

+ AMAG PHARMS INC

27.2MG IRON/5ML (5.44MG IRON/ML)

272MG IRON/50ML (5.44MG IRON/ML)

N206317 001 Jan 23, 2015

N206317 002 Sep 04, 2015

EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

N022180 001 Jun 30, 2009

FESOTERODINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL

FESOTERODINE FUMARATE
AB
ALKEM LABS LTD
4MG

AB
8MG

TOVIAZ
AB
PFIZER
4MG

AB
+
8MG

FEXOFENADINE HYDROCHLORIDE

SUSPENSION;ORAL

ALLEGRA

AB
+ SANOFI AVENTIS US

FEXOFENADINE HYDROCHLORIDE

AB
ACTAVIS MID ATLANTIC

TABLET;ORAL

FEXOFENADINE HYDROCHLORIDE

AB
BARR

AB

AB

AB
DR REDDYS LABS LTD

AB

AB

AB
MYLAN

AB

AB

AB
TEVA

AB

AB

A204827 001 Dec 10, 2015

A204827 002 Dec 10, 2015

N022030 001 Oct 31, 2008

N022030 002 Oct 31, 2008

30MG/5ML

N021963 001 Oct 16, 2006

30MG/5ML

A201311 001 Jul 25, 2012

30MG

60MG

180MG

30MG

60MG

180MG

30MG

60MG

180MG

30MG

60MG

180MG

A076191
A076191
A076191
A076502
A076502
A076502
A077081
A077081
A077081
A076447
A076447
A076447

001
002
003
001
002
003
002
003
001
001
002
003

Aug
Aug
Aug
Apr
Apr
Apr
Apr
Apr
Apr
Sep
Sep
Sep

31,
31,
31,
11,
11,
11,
11,
11,
16,
01,
01,
01,

2005

2005

2005

2006

2006

2006

2008

2008

2007

2005

2005

2005

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

AB
BARR

60MG;120MG

AB
IMPAX PHARMS

60MG;120MG

A076236 001 Apr 14, 2005

A076298 001 Nov 12, 2010

FIDAXOMICIN

TABLET;ORAL

DIFICID

+ CUBIST PHARMS LLC

200MG

N201699 001 May 27, 2011

FINAFLOXACIN

SUSPENSION/DROPS;OTIC

XTORO

+ ALCON RES LTD

0.3%

N206307 001 Dec 17, 2014

FINASTERIDE

TABLET;ORAL

FINASTERIDE

AB
ACCORD HLTHCARE

AB
ACCORD HLTHCARE INC
AB
ACTAVIS TOTOWA
AB
AB
AUROBINDO PHARMA
AB
AUROBINDO PHARMA LTD
AB
CIPLA LTD
AB
DR REDDYS LABS INC
DR REDDYS LABS LTD
AB
AB
GEDEON RICHTER USA
AB
HETERO LABS LTD III
AB
AB
MYLAN
AB
MYLAN PHARMS INC
AB
SUN PHARMA GLOBAL
AB

5MG

1MG
1MG
5MG
5MG
1MG
1MG
1MG
5MG
5MG
1MG
5MG
5MG
1MG
1MG
5MG

A090121
A091643
A078371
A077914
A078341
A203687
A077335
A076436
A076437
A077251
A090060
A090061
A077578
A078161
A090508
A090507

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Feb
Nov
Nov
Mar
Oct
Nov
Nov
Jul
Feb
Dec
Jul
Jun
Dec
Nov
Jul
Aug

23,
05,
05,
28,
30,
05,
20,
28,
28,
22,
01,
07,
18,
05,
01,
16,

2010

2013

2013

2007

2007

2013

2014

2006

2007

2006

2013

2010

2006

2013

2013

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-160(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FINASTERIDE

TABLET;ORAL

FINASTERIDE

AB
TEVA
AB
AB
ZYDUS PHARMS USA INC
PROPECIA

AB
+ MERCK
PROSCAR

AB
+ MERCK

1MG
5MG
5MG

A076905 001 Nov 05, 2013

A076511 001 Dec 15, 2006

A078900 001 Dec 28, 2009

1MG

N020788 001 Dec 19, 1997

5MG

N020180 001 Jun 19, 1992

FINGOLIMOD

CAPSULE;ORAL

GILENYA

+ NOVARTIS

0.5MG

N022527 001 Sep 21, 2010

FLAVOXATE HYDROCHLORIDE

TABLET;ORAL

FLAVOXATE HYDROCHLORIDE

AB
EPIC PHARMA
AB
IMPAX PHARMS
AB
+ PADDOCK LLC

100MG
100MG
100MG

A076835 001 Nov 30, 2005

A076234 001 Aug 28, 2003

A076831 001 Dec 16, 2004

FLECAINIDE ACETATE

TABLET;ORAL

FLECAINIDE ACETATE

AB
AMNEAL PHARM
AB
AB
AB
ANI PHARMS INC
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
ROXANE
AB
AB
+
AB
SUN PHARM INDS LTD
AB
AB

50MG
100MG
150MG
50MG
100MG
150MG
50MG
100MG
150MG
50MG
100MG
150MG
50MG
100MG
150MG

A075442
A075442
A075442
A075882
A075882
A075882
A202821
A202821
A202821
A076278
A076278
A076278
A076421
A076421
A076421

FLIBANSERIN

TABLET;ORAL

ADDYI

+ SPROUT PHARMS

100MG

N022526 001 Aug 18, 2015

FLORBETABEN F-18

SOLUTION;INTRAVENOUS

NEURACEQ

+ PIRAMAL IMAGING

30ML (1.4-135mCi/ML)

N204677 001 Mar 19, 2014

FLORBETAPIR F-18

SOLUTION;INTRAVENOUS

AMYVID

+ AVID RADIOPHARMS INC
+
+

10ML (13.5-51mCi/ML)
10-30ML (13.5-51mCi/ML)
10-50ML (13.5-51mCi/ML)

N202008 001 Apr 06, 2012

N202008 002 Apr 06, 2012

N202008 003 Apr 06, 2012

FLOXURIDINE

INJECTABLE;INJECTION

FLOXURIDINE

AP
+ EUROHLTH INTL SARL
AP
FRESENIUS KABI USA

500MG/VIAL
500MG/VIAL

A075387 001 Apr 16, 2000

A075837 001 Feb 22, 2001

50MG/5ML
200MG/5ML

N020090 001 Dec 23, 1993

N020090 002 Dec 23, 1993

50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML
50MG/5ML

A079150
A079150
A077523
A077523
A076246

FLUCONAZOLE

FOR SUSPENSION;ORAL

DIFLUCAN

AB
PFIZER
AB
+
FLUCONAZOLE

AB
AUROBINDO PHARM
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
ROXANE

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

001
002
001
002
001

Jul
Jul
Jul
Oct
Oct
Oct
Jul
Jul
Jul
Jan
Jan
Jan
Mar
Mar
Mar

Sep
Sep
Sep
Sep
Jul

31,
31,
31,
28,
28,
28,
08,
08,
08,
14,
14,
14,
28,
28,
28,

18,
18,
12,
12,
29,

2001

2001

2001

2002

2002

2002

2015

2015

2015

2003

2003

2003

2003

2003

2003

2009

2009

2007

2007

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-161(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUCONAZOLE

FOR SUSPENSION;ORAL

FLUCONAZOLE

AB
200MG/5ML
AB
SUN PHARM INDS LTD
50MG/5ML
AB
200MG/5ML
INJECTABLE;INJECTION

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ PFIZER
200MG/100ML (2MG/ML)
AP
+
400MG/200ML (2MG/ML)
DIFLUCAN IN SODIUM CHLORIDE 0.9%

AP
+ PFIZER
200MG/100ML (2MG/ML)
AP
+
400MG/200ML (2MG/ML)
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
+ PFIZER
200MG/100ML (2MG/ML)
AP
+
400MG/200ML (2MG/ML)
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
ACS DOBFAR INFO SA
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
CLARIS PHARMASERVICE
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
HIKMA FARMACEUTICA
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
HOSPIRA
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

AP
BEDFORD
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
CLARIS PHARMASERVICE
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
FRESENIUS KABI USA
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
HIKMA FARMACEUTICA
200MG/100ML (2MG/ML)
AP
TEVA PHARMS USA
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
BEDFORD LABS
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
CLARIS PHARMASERVICE
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
HIKMA FARMACEUTICA
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
AP
HOSPIRA
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

BEDFORD
100MG/50ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

CLARIS PHARMASERVICE
100MG/50ML (2MG/ML)
TABLET;ORAL

DIFLUCAN

AB
PFIZER
50MG
AB
100MG
AB
150MG
AB
+
200MG
FLUCONAZOLE

50MG
AB
APOTEX
AB
100MG
AB
150MG
AB
200MG
AB
AUROBINDO PHARMA
50MG
AB
100MG
AB
150MG
AB
200MG
AB
DR REDDYS LABS INC
50MG
AB
100MG
AB
150MG
AB
200MG
AB
GLENMARK GENERICS
50MG
AB
100MG

A076246 002 Jul 29, 2004

A076332 001 Jul 29, 2004

A076332 002 Jul 29, 2004

N019950 003 Sep 29, 1992

N019950 005 Jul 08, 1994

N019950 001 Jan 29, 1990

N019950 006 Jan 29, 1990

N019950 002 Jan 29, 1990

N019950 004 Jan 29, 1990

A079104 001 Jul 30, 2009

A079104 002 Jul 30, 2009

A077988
A077988
A078764
A078764
A076304
A076304

001
002
001
002
001
002

May
May
Jan
Jan
Jul
Jul

26,
26,
30,
30,
29,
29,

2010

2010

2012

2012

2004

2004

A076087
A076087
A077947
A077947
A076145
A076145
A076736
A076653
A076653

001
003
001
002
001
002
001
001
002

Jul
Jul
May
May
Jul
Jul
Aug
Jul
Jul

29,
29,
26,
26,
29,
29,
23,
29,
29,

2004

2004

2010

2010

2004

2004

2005

2004

2004

A076766
A076766
A078107
A078107
A077909
A077909
A078698
A078698
A076303
A076303

001
002
001
002
001
002
001
002
001
002

Jul
Jul
Jul
Jul
May
May
Jan
Jan
Jul
Jul

29,
29,
30,
30,
26,
26,
30,
30,
29,
29,

2004

2004

2008

2008

2010

2010

2012

2012

2004

2004

A076087 002 Sep 26, 2008

A077909 003 Apr 20, 2015

N019949
N019949
N019949
N019949

001
002
004
003

Jan
Jan
Jun
Jan

29,
29,
30,
29,

1990

1990

1994

1990

A076665
A076665
A076665
A076665
A077731
A077731
A077731
A077731
A076658
A076658
A076658
A076658
A077253
A077253

001
002
003
004
001
002
003
004
001
002
003
004
001
002

Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Jul
Jul
Jul
Jul
Jan
Jan

29,
29,
29,
29,
07,
07,
07,
07,
29,
29,
29,
29,
25,
25,

2004

2004

2004

2004

2008

2008

2008

2008

2004

2004

2004

2004

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-162(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUCONAZOLE

TABLET;ORAL

FLUCONAZOLE

AB

AB

AB
HARRIS PHARM

AB

AB

AB

AB
IVAX SUB TEVA PHARMS

AB

AB

AB

AB
MYLAN

AB

AB

AB

AB
TARO

AB

AB

AB

AB
TEVA

AB

AB

AB

AB
UNIQUE PHARM LABS

AB

AB

150MG

200MG

50MG

100MG

150MG

200MG

50MG

100MG

150MG

200MG

50MG

100MG

150MG

200MG

50MG

100MG

150MG

200MG

50MG

100MG

150MG

200MG

50MG

100MG

200MG

A077253
A077253
A078423
A078423
A078423
A078423
A076077
A076077
A076077
A076077
A076351
A076351
A076351
A076351
A076507
A076507
A076507
A076507
A074681
A074681
A074681
A074681
A076957
A076957
A076957

250MG

500MG

N017001 001

N017001 002

250MG

500MG

A201566 001 Jun 28, 2011

A201566 002 Jun 28, 2011

FLUDARABINE PHOSPHATE

INJECTABLE;INJECTION

FLUDARABINE PHOSPHATE

AP
ACTAVIS TOTOWA
AP
+ FRESENIUS KABI USA
AP
AP
+ HOSPIRA
AP
MUSTAFA NEVZAT ILAC
AP
MYLAN LABS LTD
AP
AP
+ SANDOZ
AP
TEVA PHARMS USA
AP

50MG/VIAL

50MG/2ML (25MG/ML)

50MG/VIAL

50MG/VIAL

50MG/2ML (25MG/ML)

50MG/2ML (25MG/ML)

50MG/VIAL

50MG/2ML (25MG/ML)

50MG/VIAL

50MG/2ML (25MG/ML)

A078610
A078393
A078544
A077790
A090724
A200647
A200648
N022137
A076349
A076661

001
001
001
001
001
001
001
001
001
001

Feb
Oct
Oct
Apr
Sep
Dec
Oct
Sep
Aug
Apr

11,
15,
15,
06,
27,
21,
16,
21,
28,
28,

2009

2007

2007

2007

2010

2011

2012

2007

2003

2004

FLUDEOXYGLUCOSE F-18

INJECTABLE;INTRAVENOUS

FLUDEOXYGLUCOSE F18

AP
3D IMAGING DRUG

AP
BIOMEDCL RES FDN

AP

AP
BRIGHAM WOMENS

AP
CARDINAL HEALTH 414

AP
CHILDRENS HOSP MI

AP
CPDC

AP
ESSENTIAL ISOTOPES

AP
+ FEINSTEIN

AP
+

AP
GLOBAL ISOTOPES LLC

AP
+ HOUSTON CYCLOTRON

AP
IBA MOLECULAR N AM

AP
KETTERING MEDCTR

AP
LANTHEUS MEDICAL

AP
MA GENERAL HOSP

AP
MCPRF

AP
METHODIST HOSP RES

AP
MIDWEST MEDCL

20-300mCi/ML

20-300mCi/ML

20-300mCi/ML

20-300mCi/ML

20-300mCi/ML

20-300mCi/ML

20-300mCi/ML

20-300mCi/ML

20-200mCi/ML

20-400mCi/ML

20-300mCi/ML

20-500mCi/ML

20-300mCi/ML

4-40mCi/ML

20-200mCi/ML

20-300mCi/ML

20-240mCi/ML

20-300mCi/ML

20-200mCi/ML

A203778
A203710
A203837
A203816
A203603
A204385
A204525
A203946
N021870
N021870
A204463
A203665
A203591
A204759
A203664
A204333
A203612
A203904
A203736

001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001

Oct
May
May
Oct
Nov
Oct
Oct
Feb
Aug
Nov
Oct
Feb
Aug
Oct
Feb
Sep
Aug
Apr
Nov

30,
01,
01,
30,
13,
29,
29,
05,
19,
21,
21,
14,
31,
27,
04,
25,
05,
23,
19,

2015

2015

2015

2014

2015

2014

2014

2014

2005

2008

2014

2013

2015

2015

2014

2014

2013

2015

2015

FLUCYTOSINE

CAPSULE;ORAL

ANCOBON

AB
VALEANT

AB
+

FLUCYTOSINE

AB
SIGMAPHARM LABS LLC

AB

003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003

Jan
Jan
Mar
Mar
Mar
Mar
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep

25,
25,
07,
07,
07,
07,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
28,
28,
28,

2006

2006

2011

2011

2011

2011

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2004

2005

2005

2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-163(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUDEOXYGLUCOSE F-18

INJECTABLE;INTRAVENOUS

FLUDEOXYGLUCOSE F18

AP
MIPS CRF
AP
NCM USA BRONX LLC
AP
PETNET
AP
SHERTECH LABS LLC
AP
TRIAD ISOTOPES INC
AP
TRUSTEES UNIV PA
AP
+ UCLA BIOMEDICAL
AP
UCSF RODIOPHARM
AP
UIHC PET IMAGING
AP
UNIV MICHIGAN
AP
UNIV TX MD ANDERSON
AP
UNIV UTAH CYCLOTRON
AP
WI MEDCL CYCLOTRON
AP
WUSM CYCLOTRON
HOT SHOTS NM LLC
PRECISION NUCLEAR
QUEEN HAMAMATSU PET
SPECTRON MRC LLC
UNIV NORTH DAKOTA
UNIV TX MD ANDERSON

20-300mCi/ML
20-300mCi/ML
20-200mCi/ML
20-300mCi/ML
20-300mCi/ML
20-200mCi/ML
4-40mCi/ML
20-300mCi/ML
20-300mCi/ML
20-300mCi/ML
20-300mCi/ML
20-300mCi/ML
20-500mCi/ML
20-300mCi/ML
4-500mCi/ML
20-500mCi/ML
10-100mCi/ML
4-500mCi/ML
4-500mCi/ML
20-150mCi/ML

A204472
A204512
A079086
A204264
A203920
A203801
A203811
A203902
A203990
A204531
A203246
A204498
A203709
A203935
A203937
A204546
A203771
A203911
A203994
A203246

FLUDROCORTISONE ACETATE

TABLET;ORAL

FLUDROCORTISONE ACETATE

AB
BARR
AB
HIKMA PHARMS
AB
+ IMPAX LABS

0.1MG
0.1MG
0.1MG

A040425 001 Jan 21, 2003

A091302 001 Jul 22, 2011

A040431 001 Mar 18, 2002

FLUMAZENIL

INJECTABLE;INJECTION

FLUMAZENIL

AP
BEDFORD LABS
AP
AP
EUROHLTH INTL SARL
AP
AP
FRESENIUS KABI USA
AP
AP
HIKMA FARMACEUTICA
AP
AP
MYLAN LABS LTD
AP
+
AP
SAGENT PHARMS
AP
AP
SANDOZ
AP

0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)
0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)
0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)
0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)
0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)
0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)
0.5MG/5ML (0.1MG/ML)
1MG/10ML (0.1MG/ML)

A076256
A076256
A076787
A076787
A076955
A076955
A078527
A078527
A078595
A078595
A090584
A090584
A077071
A077071

0.078MG/INH

N021247 001 Jan 27, 2006

0.025MG/SPRAY
0.025MG/SPRAY
0.029MG/SPRAY

A074805 001 Feb 20, 2002

A077704 001 Aug 03, 2006

A077436 001 Aug 09, 2007

0.01%
0.025%
0.01%
0.025%
0.025%

A088170
A088169
A089526
A089525
A087104

0.01%
0.025%
0.025%

N012787 004

N012787 002

N012787 005

0.19MG

N201923 001 Sep 26, 2014

FLUNISOLIDE

AEROSOL, METERED;INHALATION

AEROSPAN HFA

+ MEDA PHARMS INC
SPRAY, METERED;NASAL

FLUNISOLIDE

AB
+ BAUSCH AND LOMB
AB
HI TECH PHARMA CO
+ APOTEX INC
FLUOCINOLONE ACETONIDE

CREAM;TOPICAL

FLUOCINOLONE ACETONIDE

AT
FOUGERA
AT
AT
G AND W LABS
AT
AT
TARO
SYNALAR

AT
+ MEDIMETRIKS PHARMS
AT
+
AT
+
IMPLANT;INTRAVITREAL

ILUVIEN

+ ALIMERA SCIENCES INC

001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001

002
001
002
001
002
001
001
002
001
002
001
002
001
002

001
001
001
001
001

Sep
Jan
Feb
Dec
Jun
Oct
Jun
May
Aug
Jul
Jan
Jun
Oct
Feb
Oct
Apr
Aug
Apr
Feb
Jan

Oct
Oct
Oct
Oct
Oct
Oct
Mar
Mar
May
May
Aug
Aug
May
May

Dec
Dec
Jul
Jul
Apr

11,
07,
25,
18,
23,
29,
27,
09,
06,
17,
13,
23,
23,
05,
30,
07,
31,
22,
04,
13,

12,
12,
12,
12,
12,
12,
23,
23,
13,
13,
28,
28,
03,
03,

16,
16,
26,
26,
27,

2015

2015

2011

2014

2015

2014

2013

2014

2014

2015

2014

2015

2013

2014

2014

2015

2015

2015

2015

2014

2004

2004

2004

2004

2004

2004

2009

2009

2008

2008

2012

2012

2005

2005

1982

1982

1988

1988

1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-164(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUOCINOLONE ACETONIDE

IMPLANT;INTRAVITREAL

RETISERT

+ BAUSCH AND LOMB
OIL;TOPICAL

DERMA-SMOOTHE/FS

AT
+ HILL DERMAC
AT
+
FLUOCINOLONE ACETONIDE

AT
IDENTI PHARMS INC
AT
AT
PERRIGO ISRAEL
AT
AT
VERSAPHARM INC
OIL/DROPS;OTIC

DERMOTIC

AT
+ HILL DERMAC
FLUOCINOLONE ACETONIDE

AT
IDENTI PHARMS INC
OINTMENT;TOPICAL

FLUOCINOLONE ACETONIDE

AT
FOUGERA
AT
G AND W LABS
AT
TARO
SYNALAR

AT
+ MEDIMETRIKS PHARMS
SHAMPOO;TOPICAL

CAPEX

+ GALDERMA LABS LP
SOLUTION;TOPICAL

FLUOCINOLONE ACETONIDE

AT
FOUGERA
AT
GAVIS PHARMS LLC
AT
TARO
SYNALAR

AT
+ MEDIMETRIKS PHARMS

0.59MG

N021737 001 Apr 08, 2005

0.01%
0.01%

N019452 001 Feb 03, 1988

N019452 002 Nov 09, 2005

0.01%
0.01%
0.01%
0.01%
0.01%

A201759
A201764
A202847
A202848
A091514

0.01%

N019452 003 Nov 09, 2005

0.01%

A091306 001 Oct 17, 2011

0.025%
0.025%
0.025%

A088168 001 Dec 16, 1982

A089524 001 Jul 26, 1988

A040041 001 Sep 15, 1994

0.025%

N013960 001

0.01%

N020001 001 Aug 27, 1990

0.01%
0.01%
0.01%

A088167 001 Dec 16, 1982

A206422 001 Sep 02, 2015

A089124 001 Sep 11, 1985

0.01%

N015296 001

001
001
001
001
001

Oct
Oct
Aug
Aug
Jun

17,
17,
09,
09,
25,

2011

2011

2013

2013

2015

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

CREAM;TOPICAL

TRI-LUMA

+ GALDERMA LABS LP
0.01%;4%;0.05%

N021112 001 Jan 18, 2002

FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE

CREAM;TOPICAL

NEO-SYNALAR

+ MEDIMETRIKS PHARMS
0.025%;EQ 3.5MG BASE/GM

A060700 001

FLUOCINONIDE

CREAM;TOPICAL

FLUOCINONIDE

AB
FOUGERA PHARMS INC
0.1%
AB
GLENMARK GENERICS
0.1%
AB
PERRIGO ISRAEL
0.1%
AB
TARO
0.1%
VANOS

AB
+ MEDICIS
0.1%
FLUOCINONIDE

AB1
FOUGERA
0.05%
AB1
G AND W LABS INC
0.05%
AB1 + TARO
0.05%
AB1
TEVA
0.05%
FLUOCINONIDE EMULSIFIED BASE

AB2
FOUGERA PHARMS
0.05%
AB2 + TARO
0.05%
AB2
TEVA
0.05%
GEL;TOPICAL
FLUOCINONIDE
AB
FOUGERA
0.05%
AB
G AND W LABS INC
0.05%
AB
+ TARO
0.05%
OINTMENT;TOPICAL
FLUOCINONIDE
AB
FOUGERA PHARMS
0.05%
AB
+ TARO
0.05%

A200735
A091282
A090256
A200734

001
001
001
001

Jul
Jul
Jan
Jul

14,
14,
14,
14,

2014

2014

2014

2014

N021758 001 Feb 11, 2005

A073030
A073085
N019117
A072488

001
001
001
001

Oct
Feb
Jun
Feb

17,
14,
26,
06,

1994

1992

1984

1989

A076586 001 Jun 23, 2004

A072494 001 Jan 19, 1989

A072490 001 Feb 07, 1989

A072933 001 Dec 30, 1994

A072537 001 Feb 07, 1989
A074935 001 Jul 29, 1997

A074905 001 Aug 26, 1997

A075008 001 Jun 30, 1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-165(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUOCINONIDE

OINTMENT;TOPICAL

FLUOCINONIDE

AB
TEVA
SOLUTION;TOPICAL

FLUOCINONIDE

AT
FOUGERA
AT
G AND W LABS INC
AT
+ TARO
AT
TEVA
LIDEX

AT
CNTY LINE PHARMS
FLUORESCEIN SODIUM

INJECTABLE;INTRAVENOUS

AK-FLUOR 10%

AP
AKORN
FLUORESCITE

AP
+ ALCON PHARMS LTD
AK-FLUOR 25%

+ AKORN
FLUOROMETHOLONE

OINTMENT;OPHTHALMIC

FML

+ ALLERGAN
SUSPENSION/DROPS;OPHTHALMIC

FML

+ ALLERGAN
FML FORTE

ALLERGAN
FLUOROMETHOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC

FLAREX

+ ALCON
FLUOROURACIL

CREAM;TOPICAL

CARAC

AB
+ VALEANT PHARMS NORTH
EFUDEX

AB
+ VALEANT PHARM INTL
FLUOROURACIL

AB
SPEAR PHARMS
AB
SPEAR PHARMS INC
AB
TARO
FLUOROPLEX

+ AQUA PHARMS
TOLAK

+ HILL DERMACEUTICALS
INJECTABLE;INJECTION

FLUOROURACIL

AP
+ ACCORD HLTHCARE
AP
+
AP
+
AP
+
AP
+ FRESENIUS KABI USA
AP
+
AP
+
AP
+
AP
MYLAN LABS LTD
AP
AP
AP
AP
SANDOZ
AP
AP
+ TEVA PHARMS USA
AP
+
AP
+
SOLUTION;TOPICAL

EFUDEX

AT
+ VALEANT PHARM INTL
AT
+

0.05%

A073481 001 Dec 27, 1991

0.05%
0.05%
0.05%
0.05%

A072934
A071535
A074799
A072511

0.05%

N018849 001 Apr 06, 1984

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

N022186 001 Aug 08, 2008

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

N021980 001 Mar 28, 2006

EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

N022186 002 Aug 08, 2008

0.1%

N017760 001 Sep 04, 1985

0.1%

N016851 002 Jul 28, 1982

0.25%

N019216 001 Apr 23, 1986

0.1%

N019079 001 Feb 11, 1986

0.5%

N020985 001 Oct 27, 2000

5%

N016831 003

5%
0.5%
5%

A077524 001 Apr 11, 2008

A203122 001 Apr 20, 2015

A090368 001 Mar 05, 2010

1%

N016988 001

4%

N022259 001 Sep 18, 2015

500MG/10ML (50MG/ML)
1GM/20ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)
500MG/10ML (50MG/ML)
1GM/20ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)
500MG/10ML (50MG/ML)
1GM/20ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)
500MG/10ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)

A040743
A040743
A040798
A040798
A040279
A040279
A040278
A040278
A202668
A202668
A202669
A202669
A091299
A091299
A040333
A040334
A040334

2%
5%

N016831 001

N016831 002

001
001
001
001

002
001
002
001
002
001
001
002
001
002
001
002
001
002
001
001
002

Feb
Dec
Dec
Feb

Apr
Apr
Apr
Apr
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
May
May
Jan
Feb
Feb

27,
02,
31,
07,

26,
26,
26,
26,
30,
30,
30,
30,
17,
17,
17,
17,
02,
02,
27,
25,
25,

1995

1988

1996

1989

2007

2007

2007

2007

1998

1998

1998

1998

2012

2012

2012

2012

2011

2011

2000

2000

2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-166(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUOROURACIL

SOLUTION;TOPICAL

FLUOROURACIL

AT
TARO

AT

A076526 001 Nov 05, 2003

A076526 002 Nov 05, 2003

2%

5%

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

FLUOXETINE HYDROCHLORIDE
AB
ALEMBIC PHARMS LTD
EQ 40MG
AB
AUROBINDO PHARMA
EQ 40MG
AB
DR REDDYS LABS LTD
EQ 40MG
AB
HERITAGE PHARMS INC
EQ 40MG
AB
IVAX SUB TEVA PHARMS
EQ 40MG
AB
MYLAN
EQ 40MG
AB
PAR PHARM
EQ 40MG
AB
SANDOZ
EQ 40MG
AB
SCIEGEN PHARMS INC
EQ 40MG
AB
SUN PHARM INDS LTD
EQ 40MG
AB
TEVA
EQ 40MG
PROZAC
AB
+ ELI LILLY AND CO
EQ 40MG
FLUOXETINE HYDROCHLORIDE
AB1
ALEMBIC PHARMS LTD
EQ 10MG
AB1
EQ 20MG
AB1
AUROBINDO PHARMA
EQ 10MG
AB1
EQ 20MG
AB1
BARR
EQ 10MG
AB1
EQ 20MG
AB1
DR REDDYS LABS LTD
EQ 10MG
AB1
EQ 20MG
AB1
HERITAGE PHARMS INC
EQ 10MG
AB1
EQ 20MG
AB1
IVAX SUB TEVA PHARMS
EQ 10MG
AB1
EQ 20MG
AB1
LANDELA PHARM
EQ 10MG
AB1
EQ 20MG
AB1
MALLINCKRODT
EQ 10MG
AB1
EQ 20MG
AB1
MYLAN
EQ 10MG
AB1
EQ 20MG
AB1
MYLAN PHARMS INC
EQ 10MG
AB1
EQ 20MG
AB1
SANDOZ
EQ 10MG
AB1
EQ 20MG
AB1
SCIEGEN PHARMS INC
EQ 10MG
AB1
EQ 20MG
AB1
TEVA
EQ 10MG
AB1
EQ 20MG
AB1
TEVA PHARMS USA
EQ 10MG
AB1
EQ 20MG
PROZAC
AB1
ELI LILLY AND CO
EQ 10MG
AB1
EQ 20MG
FLUOXETINE HYDROCHLORIDE
AB2
MYLAN
EQ 10MG
+
EQ 20MG
CAPSULE, DELAYED REL PELLETS;ORAL

FLUOXETINE HYDROCHLORIDE

AB
BARR

EQ 90MG
AB
DR REDDYS LABS LTD

EQ 90MG
PROZAC WEEKLY

AB
+ LILLY

EQ 90MG
SOLUTION;ORAL

FLUOXETINE HYDROCHLORIDE

AA
AUROBINDO PHARM
EQ 20MG
AA
LANNETT
EQ 20MG
AA
MALLINCKRODT
EQ 20MG
AA
+ PHARM ASSOC
EQ 20MG
AA
SILARX
EQ 20MG
AA
TEVA
EQ 20MG
AA
WOCKHARDT
EQ 20MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A090223
A078619
A075465
A201336
A075245
A075207
A076922
A075049
A204597
A076990
A075452

003
003
003
003
003
003
003
003
003
001
003

BASE

N018936 003 Jun 15, 1999

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A090223
A090223
A078619
A078619
A074803
A074803
A075465
A075465
A201336
A201336
A075245
A075245
A075464
A075464
A075658
A075658
A075207
A075207
A075577
A075577
A075049
A075049
A204597
A204597
A075452
A075452
A076001
A076001

BASE

BASE

N018936 006 Dec 23, 1992

N018936 001 Dec 29, 1987

BASE

BASE

A078045 001 Nov 17, 2008

A078045 002 Nov 17, 2008

BASE

BASE

A076237 001 Mar 24, 2010

A078572 001 Mar 22, 2010

BASE

N021235 001 Feb 26, 2001

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

A079209
A076458
A075920
A076015
A077849
A075506
A075514

001
002
001
002
002
001
001
002
001
002
002
001
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

001
001
001
001
001
001
001

Mar
Jan
Aug
Oct
Sep
May
Dec
Jan
Mar
Dec
Jan

Mar
Mar
Jan
Jan
Jan
Aug
Jan
Jan
Oct
Oct
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Aug
Jan
Mar
Mar
Jan
Jan
Jan
Jan

Mar
May
Jan
Jan
Feb
Aug
Aug

19,
31,
02,
01,
28,
25,
16,
29,
16,
13,
29,

19,
19,
31,
31,
30,
02,
29,
29,
01,
01,
31,
31,
30,
30,
29,
29,
30,
30,
29,
29,
02,
29,
16,
16,
29,
29,
29,
29,

20,
14,
29,
30,
09,
02,
29,

2009

2008

2001

2012

2004

2007

2004

2002

2015

2004

2002

2009

2009

2008

2008

2002

2001

2002

2002

2012

2012

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2001

2002

2015

2015

2002

2002

2002

2002

2009

2004

2002

2002

2007

2001

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-167(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUOXETINE HYDROCHLORIDE

TABLET;ORAL

FLUOXETINE HYDROCHLORIDE

AB
DR REDDYS LABS INC

AB
MYLAN

AB
TEVA

SARAFEM

AB1
WARNER CHILCOTT LLC

AB1

AB1 +

SELFEMRA

AB1
TEVA PHARMS USA

AB1

AB1

FLUOXETINE HYDROCHLORIDE

EDGEMONT PHARMS LLC

+ MYLAN

EQ 10MG BASE

EQ 10MG BASE

EQ 10MG BASE

A076006 001 Jan 30, 2002

A075755 001 Aug 02, 2001

A075872 001 Jan 29, 2002

EQ 10MG BASE

EQ 15MG BASE

EQ 20MG BASE

N021860 001 May 19, 2006

N021860 002 May 19, 2006

N021860 003 May 19, 2006

EQ 10MG BASE

EQ 15MG BASE

EQ 20MG BASE

A200151 001 Feb 03, 2014

A200151 002 Feb 03, 2014

A200151 003 Feb 03, 2014

EQ 60MG BASE

EQ 20MG BASE

N202133 001 Oct 06, 2011

A075755 002 Aug 02, 2001

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

CAPSULE;ORAL

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

AB
PAR PHARM

EQ 25MG BASE;EQ
AB

EQ 25MG BASE;EQ
AB

EQ 25MG BASE;EQ
AB

EQ 50MG BASE;EQ
AB

EQ 50MG BASE;EQ
EQ 25MG BASE;EQ
AB
SANDOZ

EQ 25MG BASE;EQ
AB

EQ 25MG BASE;EQ
AB

EQ 50MG BASE;EQ
AB

EQ 50MG BASE;EQ
AB

EQ 25MG BASE;EQ
AB
TEVA PHARMS

EQ 25MG BASE;EQ
AB

EQ 25MG BASE;EQ
AB

EQ 50MG BASE;EQ
AB

EQ 50MG BASE;EQ
AB

SYMBYAX

EQ 25MG BASE;EQ
AB
LILLY

EQ 25MG BASE;EQ
AB

EQ 25MG BASE;EQ
AB

EQ 50MG BASE;EQ
AB
+

EQ 50MG BASE;EQ
AB

3MG BASE

6MG BASE

12MG BASE

6MG BASE

12MG BASE

3MG BASE

6MG BASE

12MG BASE

6MG BASE

12MG BASE

3MG BASE

6MG BASE

12MG BASE

6MG BASE

12MG BASE

A077742
A077742
A077742
A077742
A077742
A078901
A078901
A078901
A078901
A078901
A202074
A077528
A077528
A077528
A077528

001
002
003
004
005
005
001
003
002
004
001
001
002
003
004

Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Mar
Jun
Jun
Jun
Jun

02,
02,
02,
02,
02,
16,
16,
16,
16,
16,
25,
19,
19,
19,
19,

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2013

2012

2012

2012

2012

3MG BASE

6MG BASE

12MG BASE

6MG BASE

12MG BASE

N021520
N021520
N021520
N021520
N021520

001
002
004
003
005

Apr
Dec
Dec
Dec
Dec

09,
24,
24,
24,
24,

2007

2003

2003

2003

2003

FLUOXYMESTERONE

TABLET;ORAL

FLUOXYMESTERONE

+ USL PHARMA

10MG

A088342 001 Oct 21, 1983

FLUPHENAZINE DECANOATE

INJECTABLE;INJECTION

FLUPHENAZINE DECANOATE

AO
EUROHLTH INTL SARL
AO
+ FRESENIUS KABI USA
AO
PAR STERILE PRODUCTS

25MG/ML

25MG/ML

25MG/ML

A074531 001 Aug 30, 1996

A071413 001 Jul 14, 1987

A203732 001 Jul 03, 2014

5MG/ML

A074725 001 Sep 16, 1996

2.5MG/5ML

A040146 001 Aug 21, 1996

2.5MG/ML

A089556 001 Apr 16, 1987

1MG

2.5MG

5MG

10MG

1MG

2.5MG

5MG

A089740
A089741
A089742
A089743
A089804
A089804
A089804

FLUPHENAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

FLUPHENAZINE HYDROCHLORIDE

+ PHARM ASSOC

ELIXIR;ORAL

FLUPHENAZINE HYDROCHLORIDE

+ PHARM ASSOC

INJECTABLE;INJECTION

FLUPHENAZINE HYDROCHLORIDE

+ FRESENIUS KABI USA

TABLET;ORAL

FLUPHENAZINE HYDROCHLORIDE

AB
LANNETT

AB

AB

AB

AB
MYLAN

AB

AB

001
001
001
001
002
003
004

Aug
Aug
Aug
Aug
Aug
Aug
Aug

25,
25,
25,
25,
12,
12,
12,

1988

1988

1988

1988

1988

1988

1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-168(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUPHENAZINE HYDROCHLORIDE

TABLET;ORAL

FLUPHENAZINE HYDROCHLORIDE

AB
+

AB
SANDOZ

AB

AB

AB

10MG

1MG

2.5MG

5MG

10MG

A089804
A089583
A089584
A089585
A089586

0.025%

0.05%

N012806 003

N012806 002

0.05%

N013790 001

0.05%

N012806 001

0.004MG/SQ CM

N016455 001

FLURAZEPAM HYDROCHLORIDE

CAPSULE;ORAL

FLURAZEPAM HYDROCHLORIDE

MYLAN PHARMS INC

+

15MG

30MG

A070345 002 Nov 27, 1985

A070345 001 Nov 27, 1985

FLURBIPROFEN

TABLET;ORAL

FLURBIPROFEN

AB
MYLAN

AB
+

AB
SUN PHARM INDS INC

AB

AB
TEVA

50MG

100MG

50MG

100MG

100MG

A074358
A074358
A075058
A075058
A074431

0.03%

A074447 001 Jan 04, 1995

FLURANDRENOLIDE

CREAM;TOPICAL

CORDRAN SP

+ AQUA PHARMS

+

LOTION;TOPICAL

CORDRAN

+ AQUA PHARMS

OINTMENT;TOPICAL

CORDRAN

+ AQUA PHARMS

TAPE;TOPICAL

CORDRAN

+ ACTAVIS LABS UT INC

FLURBIPROFEN SODIUM

SOLUTION/DROPS;OPHTHALMIC

FLURBIPROFEN SODIUM

AT
BAUSCH AND LOMB

OCUFEN

AT
+ ALLERGAN

001
001
001
001
001

001
002
001
002
001

Aug
Oct
Oct
Oct
Oct

Jun
Jun
Apr
Apr
May

12,
16,
16,
16,
16,

20,
20,
27,
27,
31,

1988

1987

1987

1987

1987

1994

1994

2001

2001

1995

0.03%

N019404 001 Dec 31, 1986

FLUTAMIDE

CAPSULE;ORAL

FLUTAMIDE

AB
ACTAVIS LABS FL INC
AB
+ IVAX SUB TEVA PHARMS
AB
MYLAN
AB
PAR PHARM

125MG

125MG

125MG

125MG

A075820
A075780
A076224
A075298

FLUTEMETAMOL F-18

INJECTABLE;INTRAVENOUS

VIZAMYL

+ GE HEALTHCARE

+

40.5mCi/10ML (4.05mCi/ML)

121.5mCi/30ML (4.05mCi/ML)

N203137 001 Oct 25, 2013

N203137 002 Oct 25, 2013

0.1MG/INH

0.2MG/INH

N205625 001 Aug 20, 2014

N205625 002 Aug 20, 2014

0.0275MG/INH

N022051 001 Apr 27, 2007

FLUTICASONE FUROATE

POWDER;INHALATION

ARNUITY ELLIPTA

GLAXOSMITHKLINE

+

SPRAY, METERED;NASAL

VERAMYST

+ GLAXOSMITHKLINE

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

POWDER;INHALATION
BREO ELLIPTA
+ GLAXO GRP LTD
0.1MG/INH;EQ 0.025MG BASE/INH
0.2MG/INH;EQ 0.025MG BASE/INH

001
001
001
001

Sep
Sep
May
Sep

18,
19,
09,
18,

2001

2001

2003

2001

N204275 001 May 10, 2013

N204275 002 Apr 30, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-169(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUTICASONE PROPIONATE

AEROSOL, METERED;INHALATION

FLOVENT HFA

+ GLAXO GRP LTD
+
+
CREAM;TOPICAL

FLUTICASONE PROPIONATE

AB
FOUGERA PHARMS
AB
G AND W LABS
AB
+ PERRIGO NEW YORK
AB
TOLMAR
LOTION;TOPICAL

CUTIVATE

AB
+ FOUGERA PHARMS
FLUTICASONE PROPIONATE

AB
GLENMARK GENERICS
AB
PERRIGO ISRAEL
OINTMENT;TOPICAL

CUTIVATE

AB
+ FOUGERA PHARMS
FLUTICASONE PROPIONATE

AB
FOUGERA PHARMS
AB
G AND W LABS
AB
PERRIGO NEW YORK
POWDER;INHALATION

FLOVENT DISKUS 100

+ GLAXO GRP LTD
FLOVENT DISKUS 250

+ GLAXO GRP LTD
FLOVENT DISKUS 50

+ GLAXO GRP LTD
SPRAY, METERED;NASAL

FLONASE

AB
+ GLAXOSMITHKLINE
FLUTICASONE PROPIONATE

AB
APOTEX INC
AB
HI TECH PHARMA
AB
ROXANE
AB
WOCKHARDT

0.044MG/INH
0.11MG/INH
0.22MG/INH

N021433 003 May 14, 2004

N021433 002 May 14, 2004

N021433 001 May 14, 2004

0.05%
0.05%
0.05%
0.05%

A076451
A077055
A076793
A076633

0.05%

N021152 001 Mar 31, 2005

0.05%
0.05%

A090759 001 May 02, 2011

A091553 001 Jul 30, 2013

0.005%

N019957 001 Dec 14, 1990

0.005%
0.005%
0.005%

A076300 001 May 14, 2004

A077168 001 Mar 03, 2006

A076668 001 May 14, 2004

0.1MG/INH

N020833 002 Sep 29, 2000

0.25MG/INH

N020833 003 Sep 29, 2000

0.05MG/INH

N020833 001 Sep 29, 2000

0.05MG/SPRAY

N020121 001 Oct 19, 1994

0.05MG/SPRAY
0.05MG/SPRAY
0.05MG/SPRAY
0.05MG/SPRAY

A077538
A077570
A076504
A078492

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

AEROSOL, METERED;INHALATION

ADVAIR HFA

+ GLAXO GRP LTD
0.045MG/INH;EQ 0.021MG BASE/INH
+
0.115MG/INH;EQ 0.021MG BASE/INH
+
0.23MG/INH;EQ 0.021MG BASE/INH
POWDER;INHALATION

ADVAIR DISKUS 100/50

+ GLAXO GRP LTD

0.1MG/INH;EQ 0.05MG BASE/INH
ADVAIR DISKUS 250/50

+ GLAXO GRP LTD

0.25MG/INH;EQ 0.05MG BASE/INH
ADVAIR DISKUS 500/50

+ GLAXO GRP LTD

0.5MG/INH;EQ 0.05MG BASE/INH
FLUVASTATIN SODIUM

CAPSULE;ORAL

FLUVASTATIN SODIUM

AB
MYLAN PHARMS INC
EQ 20MG
AB
EQ 40MG
AB
TEVA PHARMS
EQ 20MG
AB
EQ 40MG
LESCOL

AB
NOVARTIS
EQ 20MG
AB
+
EQ 40MG
TABLET, EXTENDED RELEASE;ORAL

FLUVASTATIN SODIUM

AB
MYLAN PHARMS INC
80MG
LESCOL XL

AB
+ NOVARTIS
80MG

001
001
001
001

001
001
001
001

May
Jun
May
May

Sep
Jan
Feb
Jan

14,
30,
14,
14,

12,
16,
22,
09,

2004

2006

2004

2004

2007

2008

2006

2012

N021254 001 Jun 08, 2006

N021254 002 Jun 08, 2006

N021254 003 Jun 08, 2006

N021077 001 Aug 24, 2000

N021077 002 Aug 24, 2000

N021077 003 Aug 24, 2000

BASE
BASE
BASE
BASE

A090595
A090595
A078407
A078407

001
002
001
002

BASE
BASE

N020261 001 Dec 31, 1993

N020261 002 Dec 31, 1993

Apr
Apr
Jun
Jun

11,
11,
12,
12,

2012

2012

2012

2012

A202458 001 Sep 11, 2015

N021192 001 Oct 06, 2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-170(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FLUVOXAMINE MALEATE

CAPSULE, EXTENDED RELEASE;ORAL

FLUVOXAMINE MALEATE

AB
ACTAVIS ELIZABETH
100MG
AB
150MG
AB
ANCHEN PHARMS
100MG
AB
150MG
AB
TORRENT PHARMS LTD
100MG
AB
150MG
LUVOX CR

AB
JAZZ PHARMS
100MG
AB
+
150MG
TABLET;ORAL

FLUVOXAMINE MALEATE

AB
ANI PHARMS INC
25MG
AB
50MG
AB
100MG
AB
APOTEX
25MG
AB
50MG
AB
100MG
AB
MYLAN
25MG
AB
50MG
AB
100MG
AB
SANDOZ
25MG
AB
50MG
AB
+
100MG
AB
TEVA
25MG
AB
50MG
AB
100MG
LUVOX

AB
ANI PHARMS
25MG
AB
50MG
AB
100MG
FOLIC ACID

INJECTABLE;INJECTION

FOLIC ACID

+ FRESENIUS KABI USA
TABLET;ORAL

FOLIC ACID

AA
AIPING PHARM INC
AA
+ AMNEAL PHARM
AA
CADILA PHARMS LTD
AA
CONTRACT PHARMACAL
AA
HIKMA PHARMS LLC
AA
INVAGEN PHARMS
AA
LEADING PHARMA LLC
AA
NUVO PHARM INC
AA
VINTAGE
AA
+ WATSON LABS
FOLLITROPIN ALFA/BETA

INJECTABLE;SUBCUTANEOUS

FOLLISTIM AQ

+ ORGANON USA INC
+
+
+
+
GONAL-F

+ EMD SERONO
GONAL-F RFF

+ EMD SERONO
GONAL-F RFF REDI-JECT

+ EMD SERONO
+
+

A091482
A091482
A091476
A091476
A203240
A203240

001
002
001
002
001
002

Apr
Nov
Mar
Mar
Oct
Oct

23,
18,
13,
13,
31,
31,

2013

2013

2013

2013

2014

2014

N022033 001 Feb 28, 2008

N022033 002 Feb 28, 2008

A075897
A075897
A075897
A075902
A075902
A075902
A075889
A075889
A075889
A075888
A075888
A075888
A075893
A075893
A075893

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jan
Jan
Jan
May
May
May
Nov
Nov
Nov
Nov
Nov
Nov
Sep
Sep
Sep

25,
25,
25,
07,
07,
07,
29,
29,
29,
29,
29,
29,
10,
10,
10,

2001

2001

2001

2001

2001

2001

2000

2000

2000

2000

2000

2000

2002

2002

2002

N021519 001 Dec 20, 2007

N021519 002 Dec 20, 2007

N021519 003 Dec 20, 2007

5MG/ML

A089202 001 Feb 18, 1986

1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG

A091145
A040625
A202437
A085061
A080600
A090035
A040796
A204418
A040756
A080680

001
001
001
001

001

001
001
001
001
001

Jul 12, 2013

Jul 21, 2005

Jan 27, 2014

Jun
Jan
Jul
Jun

09,
12,
28,
04,

2009

2009

2015

2010

75 IU/0.5ML
150 IU/0.5ML
300 IU/0.36ML
600 IU/0.72ML
900 IU/1.08ML

N021273
N021273
N021211
N021211
N021211

001
002
001
002
004

Aug
Aug
Mar
Mar
Feb

26,
26,
23,
23,
11,

2005

2005

2004

2004

2005

450 IU/VIAL
1,050 IU/VIAL

N020378 005 Mar 26, 2004

N020378 004 Feb 28, 2001

75 IU/VIAL

N021765 002 Mar 25, 2004

300 IU/0.5ML
450 IU/0.75ML
900 IU/1.5ML

N021684 001 May 25, 2004

N021684 002 May 25, 2004

N021684 003 May 25, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-171(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FOMEPIZOLE

INJECTABLE;INJECTION

ANTIZOL

AP
+ PALADIN LABS

FOMEPIZOLE

AP
LUITPOLD

AP
MYLAN INSTITUTIONAL

AP
NAVINTA LLC

FONDAPARINUX SODIUM

INJECTABLE;SUBCUTANEOUS

ARIXTRA

AP
+ MYLAN IRELAND LTD

AP
+

AP
+

AP
+

FONDAPARINUX SODIUM

AP
DR REDDYS LABS LTD

AP

AP

AP

FORMOTEROL FUMARATE

POWDER;INHALATION

FORADIL

+ NOVARTIS

SOLUTION;INHALATION

PERFOROMIST

+ MYLAN SPECLT

1.5GM/1.5ML (1GM/ML)

N020696 001 Dec 04, 1997

1.5GM/1.5ML (1GM/ML)

1.5GM/1.5ML (1GM/ML)

1.5GM/1.5ML (1GM/ML)

A078368 001 Dec 14, 2007

A078639 001 Mar 03, 2008

A078537 001 Mar 06, 2008

2.5MG/0.5ML

5MG/0.4ML

7.5MG/0.6ML

10MG/0.8ML

N021345
N021345
N021345
N021345

001
002
003
004

Dec
May
May
May

07,
28,
28,
28,

2001

2004

2004

2004

2.5MG/0.5ML

5MG/0.4ML

7.5MG/0.6ML

10MG/0.8ML

A091316
A091316
A091316
A091316

001
002
003
004

Jul
Jul
Jul
Jul

11,
11,
11,
11,

2011

2011

2011

2011

0.012MG/INH

N020831 001 Feb 16, 2001

0.02MG/2ML

N022007 001 May 11, 2007

FORMOTEROL FUMARATE; MOMETASONE FUROATE

AEROSOL, METERED;INHALATION

DULERA

+ MERCK SHARP DOHME

0.005MG/INH;0.1MG/INH

+

0.005MG/INH;0.2MG/INH

FOSAMPRENAVIR CALCIUM

SUSPENSION;ORAL

LEXIVA

+ VIIV HLTHCARE

TABLET;ORAL

LEXIVA

+ VIIV HLTHCARE

N022518 001 Jun 22, 2010

N022518 002 Jun 22, 2010

EQ 50MG BASE/ML

N022116 001 Jun 14, 2007

EQ 700MG BASE

N021548 001 Oct 20, 2003

EQ 150MG BASE/VIAL

N022023 002 Nov 12, 2010

2.4GM/100ML

A077174 001 May 31, 2005

2.4GM/100ML

N020068 001 Sep 27, 1991

FOSFOMYCIN TROMETHAMINE

FOR SUSPENSION;ORAL

MONUROL

+ ZAMBON SPA

EQ 3GM BASE/PACKET

N050717 001 Dec 19, 1996

FOSINOPRIL SODIUM

TABLET;ORAL

FOSINOPRIL SODIUM

AB
ACTAVIS LABS FL INC

AB

AB

AB
APOTEX INC

AB

AB

AB
AUROBINDO PHARMA LTD

AB

AB

AB
INVAGEN PHARMS

AB

AB

10MG

20MG

40MG

10MG

20MG

40MG

10MG

20MG

40MG

10MG

20MG

40MG

A076620
A076620
A076620
A076906
A076906
A076906
A091163
A091163
A091163
A077222
A077222
A077222

FOSAPREPITANT DIMEGLUMINE

POWDER;INTRAVENOUS

EMEND

+ MERCK AND CO INC

FOSCARNET SODIUM

INJECTABLE;INJECTION

FOSCARNET SODIUM
AP
HOSPIRA
FOSCAVIR
AP
+ CLINIGEN HLTHCARE

001
002
003
001
002
003
001
002
003
001
002
003

Oct
Oct
Oct
May
May
May
Mar
Mar
Mar
Apr
Apr
Apr

15,
15,
15,
17,
17,
17,
30,
30,
30,
20,
20,
20,

2004

2004

2004

2005

2005

2005

2011

2011

2011

2005

2005

2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-172(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FOSINOPRIL SODIUM
TABLET;ORAL
FOSINOPRIL SODIUM
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
+

10MG
20MG
40MG
10MG
20MG
40MG

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET;ORAL

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

AB
ACTAVIS LABS FL INC
10MG;12.5MG

AB
20MG;12.5MG

AB
AUROBINDO PHARMA
10MG;12.5MG

AB
20MG;12.5MG

AB
EMCURE PHARMS INDIA
10MG;12.5MG

AB
+
20MG;12.5MG

AB
INVAGEN PHARMS
10MG;12.5MG

AB
20MG;12.5MG

AB
SANDOZ
10MG;12.5MG

AB
20MG;12.5MG

AB
SUN PHARM INDS LTD
10MG;12.5MG

AB
20MG;12.5MG

FOSPHENYTOIN SODIUM

INJECTABLE;INJECTION

CEREBYX

AP
PARKE DAVIS

FOSPHENYTOIN SODIUM

AP
AMNEAL PHARMS CO

AP
BEDFORD

AP
+ FRESENIUS KABI USA

AP
HIKMA FARMACEUTICA

AP
HIKMA MAPLE

AP
HOSPIRA

AP
LUITPOLD

AP

AP
MYLAN LABS LTD

AP
SUN PHARMA GLOBAL

AP
WOCKHARDT

FROVATRIPTAN SUCCINATE

TABLET;ORAL

FROVA

AB
+ ENDO PHARMS

FROVATRIPTAN SUCCINATE

AB
MYLAN PHARMS INC

FULVESTRANT

INJECTABLE;INTRAMUSCULAR

FASLODEX

+ ASTRAZENECA

FUROSEMIDE

INJECTABLE;INJECTION

FUROSEMIDE

AP
CLARIS LIFESCIENCES

AP
EMCURE PHARMS LTD

AP
FRESENIUS KABI USA

AP
HOSPIRA

AP

AP
+ LUITPOLD

AP
WOCKHARDT

SOLUTION;ORAL

FUROSEMIDE

AA
+ ROXANE

AA
WOCKHARDT

ROXANE

TABLET;ORAL

FUROSEMIDE

AB
IPCA LABS LTD

AB

AB

A076483
A076483
A076483
A076139
A076139
A076139

001
002
003
001
002
003

Apr
Apr
Apr
Nov
Nov
Nov

23,
23,
23,
25,
25,
25,

2004

2004

2004

2003

2003

2003

A076608
A076608
A079245
A079245
A079025
A079025
A090228
A090228
A076961
A076961
A076739
A076739

001
002
001
002
001
002
001
002
001
002
001
002

Dec
Dec
Jul
Jul
Sep
Sep
Jul
Jul
Sep
Sep
Dec
Dec

03,
03,
09,
09,
17,
17,
09,
09,
28,
28,
17,
17,

2004

2004

2009

2009

2010

2010

2009

2009

2005

2005

2004

2004

EQ 50MG PHENYTOIN NA/ML

N020450 001 Aug 05, 1996

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A078476
A077481
A078052
A078765
A077989
A078158
A078277
A090099
A078736
A078417
A078137

50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG

PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN

NA/ML

NA/ML

NA/ML

NA/ML

NA/ML

NA/ML

NA/ML

NA/ML

NA/ML

NA/ML

NA/ML

001
001
001
001
001
001
001
001
001
001
001

Mar
Aug
Aug
Dec
Aug
Aug
Aug
May
Jun
Mar
Aug

18,
06,
06,
02,
06,
06,
06,
13,
08,
18,
06,

2008

2007

2007

2009

2007

2007

2007

2010

2010

2008

2007

EQ 2.5MG BASE

N021006 001 Nov 08, 2001

EQ 2.5MG BASE

A202931 001 Aug 28, 2014

50MG/ML

N021344 001 Apr 25, 2002

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

A202747
A203428
N018902
A075241
N018667
N018579
A077941

10MG/ML

10MG/ML

40MG/5ML

A070434 001 Apr 22, 1987

A070655 001 Oct 02, 1987

A070433 001 Apr 22, 1987

20MG

40MG

80MG

A078010 001 Sep 18, 2006

A078010 002 Sep 18, 2006

A078010 003 Sep 18, 2006

001
001
001
001
001
001
001

Jan
Aug
May
May
May
Nov
Mar

27,
26,
22,
28,
28,
30,
22,

2014

2014

1984

1999

1982

1983

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-173(of 388)

PRESCRIPTION DRUG PRODUCT LIST

FUROSEMIDE

TABLET;ORAL

FUROSEMIDE

AB
IVAX SUB TEVA PHARMS
AB
AB
LEADING PHARMA LLC
AB
AB
AB
MYLAN
AB
AB
AB
ROXANE
AB
AB
AB
SANDOZ
AB
AB
AB
SUN PHARM INDS INC
AB
AB
AB
VINTAGE PHARMS
AB
AB
LASIX

AB
SANOFI AVENTIS US
AB
AB
+
GABAPENTIN

CAPSULE;ORAL

GABAPENTIN

AB
ACTAVIS ELIZABETH
AB
AB
AB
ALKEM
AB
AB
AB
AMNEAL PHARMS NY
AB
AB
AB
APOTEX INC
AB
AB
AB
AUROBINDO PHARM
AB
AB
AB
HIKMA
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
MARKSANS PHARMA
AB
AB
AB
MYLAN
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
AB
AB
AB
TARO
AB
AB
AB
TEVA PHARMS
AB
AB
NEURONTIN

AB
PFIZER PHARMS
AB

20MG
40MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG

N018413
N018413
A077293
A077293
A077293
N018487
N018487
A070082
N018823
N018823
A070086
N018569
N018569
N018569
A091258
A091258
A091258
A076796
A076796
A076796

001
002
001
002
003
001

002

001
001
002
001
002

001

005
001
002
003
001
002
003

20MG
40MG
80MG

N016273 002

N016273 001

N016273 003

100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
100MG
300MG
300MG
400MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG

A075350
A075350
A075350
A090858
A090858
A090858
A078428
A078428
A078428
A075360
A075360
A075360
A078787
A078787
A078787
A078150
A078150
A078150
A090705
A090705
A090705
A090007
A090007
A090007
A090158
A090158
A090158
A076606
A077242
A076606
A077242
A076606
A077242
A077261
A077261
A077261
A075435
A075435
A075435

100MG
300MG

N020235 001 Dec 30, 1993

N020235 002 Dec 30, 1993

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003

Nov
Nov
Nov
Nov
Nov

30,
30,
09,
09,
09,

1983

1983

2005

2005

2005

Oct
Nov
Nov
Jan

29,
10,
10,
24,

1986

1983

1983

1986

Aug
Apr
Apr
Apr
Mar
Mar
Mar

14,
01,
01,
01,
26,
26,
26,

1984

2014

2014

2014

2004

2004

2004

Sep
Sep
Sep
Dec
Dec
Dec
Jul
Jul
Jul
Apr
Apr
Apr
Jan
Jan
Jan
Sep
Sep
Sep
Dec
Dec
Dec
Jul
Jul
Jul
Feb
Feb
Feb
Oct
Aug
Oct
Aug
Oct
Aug
Aug
Aug
Aug
Oct
Oct
Oct

12,
12,
12,
17,
17,
17,
25,
25,
25,
06,
06,
06,
31,
31,
31,
25,
25,
25,
30,
30,
30,
21,
21,
21,
14,
14,
14,
07,
24,
07,
24,
07,
24,
02,
02,
02,
08,
08,
08,

2003

2003

2003

2010

2010

2010

2007

2007

2007

2005

2005

2005

2008

2008

2008

2007

2007

2007

2009

2009

2009

2011

2011

2011

2011

2011

2011

2005

2006

2005

2006

2005

2006

2013

2013

2013

2004

2004

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-174(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GABAPENTIN

CAPSULE;ORAL

NEURONTIN

AB
+
SOLUTION;ORAL

GABAPENTIN

AA
ACELLA PHARMS LLC
AA
AMNEAL PHARMS
AA
HI TECH PHARMA
AA
TARO
NEURONTIN

AA
+ PARKE DAVIS
TABLET;ORAL

GABAPENTIN

AB
ACI HEALTHCARE LTD
AB
AB
ACTAVIS ELIZABETH
AB
AB
ALKEM LABS LTD
AB
AB
APOTEX INC
AB
AB
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
GLENMARK GENERICS
AB
AB
INVAGEN PHARMS
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
AB
MYLAN PHARMS INC
AB
AB
SUN PHARM INDS LTD
AB
AB
ZYDUS PHARMS USA INC
AB
NEURONTIN

AB
PFIZER PHARMS
AB
+
GRALISE

BX
+ DEPOMED INC
BX
+

400MG

N020235 003 Dec 30, 1993

250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML

A076403
A202024
A078974
A076672

250MG/5ML

N021129 001 Mar 02, 2000

600MG
800MG
600MG
800MG
600MG
800MG
100MG
300MG
400MG
600MG
800MG
600MG
800MG
600MG
800MG
600MG
800MG
100MG
300MG
400MG
600MG
800MG
600MG
800MG
600MG
800MG
600MG
800MG

A203244
A203244
A075694
A075694
A206402
A206402
A077894
A077894
A077894
A077661
A077661
A200651
A200651
A077662
A077662
A202764
A202764
A076017
A076017
A076017
A076017
A076017
A090335
A090335
A077525
A077525
A078926
A078926

600MG
800MG

N020882 001 Oct 09, 1998

N020882 002 Oct 09, 1998

300MG
600MG

N022544 001 Jan 28, 2011

N022544 002 Jan 28, 2011

GABAPENTIN ENACARBIL

TABLET, EXTENDED RELEASE;ORAL

HORIZANT

XENOPORT INC
300MG
+
600MG

N022399 002 Dec 13, 2011

N022399 001 Apr 06, 2011

GADOBENATE DIMEGLUMINE

INJECTABLE;INTRAVENOUS

MULTIHANCE

+ BRACCO
+
+
+
MULTIHANCE MULTIPACK

+ BRACCO
+
GADOBUTROL

SOLUTION;INTRAVENOUS

GADAVIST

+ BAYER HLTHCARE
+
+
+
+

001
001
001
001

002
001
001
002
001
002
001
002
003
004
005
001
002
001
002
001
002
001
002
003
004
005
001
002
001
002
001
002

001
002
003
004

May
Mar
Feb
Jul

Jul
Jul
Oct
Oct
Dec
Dec
Oct
Oct
Oct
Sep
Sep
Oct
Oct
Aug
Aug
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Jun
Jun
Aug
Aug
Feb
Feb

12,
12,
21,
21,
23,
23,
10,
10,
10,
13,
13,
06,
06,
18,
18,
16,
16,
28,
28,
28,
29,
29,
01,
01,
24,
24,
11,
11,

2013

2013

2004

2004

2015

2015

2006

2006

2006

2006

2006

2011

2011

2006

2006

2012

2012

2004

2004

2004

2005

2005

2010

2010

2006

2006

2011

2011

N021357
N021357
N021357
N021357

26.45GM/50ML (529MG/ML)
52.9GM/100ML (529MG/ML)

N021358 001 Nov 23, 2004

N021358 002 Nov 23, 2004

1.20944GM/2ML (604.72MG/ML)
4.5354GM/7.5ML (604.72MG/ML)
6.0472GM/10ML (604.72MG/ML)
9.0708GM/15ML (604.72MG/ML)
18.1416GM/30ML (604.72MG/ML)

N201277
N201277
N201277
N201277
N201277

Dec
Mar
Mar
Mar
Mar

23,
23,
23,
23,

2012

2012

2011

2013

2.645GM/5ML (529MG/ML)
5.29GM/10ML (529MG/ML)
7.935GM/15ML (529MG/ML)
10.58GM/20ML (529MG/ML)

006
001
002
003
004

Nov
Nov
Nov
Nov

01,
23,
18,
03,

18,
14,
14,
14,
14,

2004

2004

2004

2004

2013

2011

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-175(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GADOBUTROL

SOLUTION;INTRAVENOUS

GADAVIST

+

39.3068GM/65ML (604.72MG/ML)

N201277 005 Mar 14, 2011

GADODIAMIDE

INJECTABLE;INJECTION

OMNISCAN

+ GE HEALTHCARE
+

287MG/ML
28.7GM/100ML (287MG/ML)

N020123 001 Jan 08, 1993

N022066 002 Sep 05, 2007

GADOFOSVESET TRISODIUM

SOLUTION;INTRAVENOUS

ABLAVAR

LANTHEUS MEDCL
+

2440MG/10ML (244MG/ML)
3660MG/15ML (244MG/ML)

N021711 001 Dec 22, 2008

N021711 002 Dec 22, 2008

GADOPENTETATE DIMEGLUMINE

INJECTABLE;INJECTION

MAGNEVIST

+ BAYER HLTHCARE
+

469.01MG/ML
469.01MG/ML

N019596 001 Jun 02, 1988

N021037 001 Mar 10, 2000

GADOTERATE MEGLUMINE

SOLUTION;INTRAVENOUS

DOTAREM

+ GUERBET
+
+
+

37.69GM/100ML (376.9MG/ML)
3.769GM/10ML (376.9MG/ML)
5.6535GM/15ML (376.9MG/ML)
7.538GM/20ML (376.9MG/ML)

N204781
N204781
N204781
N204781

279.3MG/ML

N020131 001 Nov 16, 1992

279.3MG/ML

N021489 001 Oct 09, 2003

GADOTERIDOL

INJECTABLE;INJECTION

PROHANCE

+ BRACCO
PROHANCE MULTIPACK

+ BRACCO

GADOVERSETAMIDE

INJECTABLE;INJECTION

OPTIMARK

+ LIEBEL-FLARSHEIM
1654.5MG/5ML (330.9MG/ML)
+
3309MG/10ML (330.9MG/ML)
+
4963.5MG/15ML (330.9MG/ML)
+
6618MG/20ML (330.9MG/ML)
+
16.545GM/50ML (330.9MG/ML)
OPTIMARK IN PLASTIC CONTAINER

+ LIEBEL-FLARSHEIM
3309MG/10ML (330.9MG/ML)
+
4963.5MG/15ML (330.9MG/ML)
+
6618MG/20ML (330.9MG/ML)
+
9927MG/30ML (330.9MG/ML)
GADOXETATE DISODIUM

SOLUTION;INTRAVENOUS

EOVIST

+ BAYER HLTHCARE

1.8143GM/10ML (181.43MG/ML)
2.72145GM/15ML (181.43MG/ML)

GALANTAMINE HYDROBROMIDE

CAPSULE, EXTENDED RELEASE;ORAL

GALANTAMINE HYDROBROMIDE

AB
BARR
EQ
AB
EQ
AB
EQ
AB
IMPAX LABS
EQ
AB
EQ
AB
EQ
AB
MYLAN
EQ
AB
EQ
AB
EQ
AB
SUN PHARMA GLOBAL
EQ
AB
EQ
AB
EQ
AB
WATSON LABS
EQ
AB
EQ
AB
EQ

8MG BASE
16MG BASE
24MG BASE
8MG BASE
16MG BASE
24MG BASE
8MG BASE
16MG BASE
24MG BASE
8MG BASE
16MG BASE
24MG BASE
8MG BASE
16MG BASE
24MG BASE

001
002
003
004

Mar
Mar
Mar
Mar

20,
20,
20,
20,

2013

2013

2013

2013

N020937
N020937
N020937
N020937
N020975

001
002
003
004
001

Dec
Dec
Dec
Dec
Dec

08,
08,
08,
08,
08,

1999

1999

1999

1999

1999

N020976
N020976
N020976
N020976

002
003
004
001

Dec
Dec
Dec
Dec

08,
08,
08,
08,

1999

1999

1999

1999

N022090 001 Jul 03, 2008

N022090 002 Feb 04, 2013

A078189
A078189
A078189
A078484
A078484
A078484
A090900
A090900
A090900
A090178
A090178
A090178
A079028
A079028
A079028

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Sep
Sep
Sep
May
May
May
Jan
Jan
Jan
Feb
Feb
Feb
Dec
Dec
Dec

15,
15,
15,
27,
27,
27,
24,
24,
24,
02,
02,
02,
15,
15,
15,

2008

2008

2008

2009

2009

2009

2011

2011

2011

2011

2011

2011

2008

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-176(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GALANTAMINE HYDROBROMIDE

CAPSULE, EXTENDED RELEASE;ORAL

RAZADYNE ER

AB
+ JANSSEN PHARMS
EQ 8MG BASE
AB
EQ 16MG BASE
AB
EQ 24MG BASE
SOLUTION;ORAL

GALANTAMINE HYDROBROMIDE

AA
ROXANE
4MG/ML
RAZADYNE

AA
+ JANSSEN PHARMS
4MG/ML
TABLET;ORAL

GALANTAMINE HYDROBROMIDE

AB
APOTEX INC
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
AB
AUROBINDO PHARMA LTD
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
AB
BARR
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
AB
DR REDDYS LABS LTD
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
AB
MYLAN
EQ 4MG BASE
AB
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
AB
EQ 12MG BASE
AB
ROXANE
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
AB
SANDOZ
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
AB
TEVA PHARMS
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
AB
ZYDUS PHARMS USA INC
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE
RAZADYNE

AB
+ JANSSEN PHARMS
EQ 4MG BASE
AB
EQ 8MG BASE
AB
EQ 12MG BASE

N021169 001 Feb 28, 2001

N021169 002 Feb 28, 2001

N021169 003 Feb 28, 2001

GALLIUM CITRATE GA-67

INJECTABLE;INJECTION

GALLIUM CITRATE GA 67

BS
LANTHEUS MEDCL
BS
MALLINKRODT NUCLEAR

2mCi/ML
2mCi/ML

N017478 001

N018058 001

GANCICLOVIR

GEL;OPHTHALMIC

ZIRGAN

+ BAUSCH AND LOMB

0.15%

N022211 001 Sep 15, 2009

EQ 500MG BASE/VIAL

N019661 001 Jun 23, 1989

EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL

A090658 001 Jun 21, 2010

A202624 001 Sep 18, 2013

EQ 250MCG BASE/0.5ML

N021057 001 Jul 29, 1999

GANCICLOVIR SODIUM

INJECTABLE;INJECTION

CYTOVENE

AP
+ ROCHE PALO
GANCICLOVIR

AP
FRESENIUS KABI USA
AP
LUITPOLD
GANIRELIX ACETATE

INJECTABLE;INJECTION

GANIRELIX ACETATE

+ ORGANON USA INC

N021615 001 Apr 01, 2005

N021615 002 Apr 01, 2005

N021615 003 Apr 01, 2005

A078185 001 Jan 30, 2009

N021224 001 Jun 22, 2001

A077781
A077781
A077781
A090957
A090957
A090957
A077605
A077605
A077605
A077593
A077593
A077593
A077590
A077603
A077590
A077603
A077590
A077603
A077608
A077608
A077608
A077589
A077589
A077589
A077587
A077587
A077587
A078898
A078898
A078898

001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003

Sep
Sep
Sep
Mar
Mar
Mar
Aug
Aug
Aug
Sep
Sep
Sep
May
Aug
May
Aug
May
Aug
Feb
Feb
Feb
Jun
Jun
Jun
Jul
Jul
Jul
Feb
Feb
Feb

27,
27,
27,
29,
29,
29,
28,
28,
28,
11,
11,
11,
29,
28,
29,
28,
29,
28,
11,
11,
11,
22,
22,
22,
09,
09,
09,
17,
17,
17,

2011

2011

2011

2011

2011

2011

2008

2008

2008

2008

2008

2008

2009

2008

2009

2008

2009

2008

2009

2009

2009

2009

2009

2009

2009

2009

2009

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-177(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GATIFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

GATIFLOXACIN

AT
HI-TECH PHARMA CO
AT
LUPIN LTD
ZYMAXID

AT
+ ALLERGAN
ZYMAR

+ ALLERGAN
GEFITINIB

TABLET;ORAL

IRESSA

+ ASTRAZENECA PHARMS
GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION

GEMCITABINE HYDROCHLORIDE

AP
ACCORD HLTHCARE
AP
AP
AP
ACTAVIS TOTOWA
AP
AP
CIPLA LTD
AP
AP
DR REDDYS LABS LTD
AP
AP
AP
EMCURE PHARMS LTD
AP
AP
FRESENIUS KABI ONCOL
AP
AP
AP
FRESENIUS KABI USA
AP
GLAND PHARMA LTD
AP
AP
HAMELN RDS GMBH
AP
AP
HOSPIRA
AP
AP
+ HOSPIRA INC
AP
JIANGSU HANSOH PHARM
AP
AP
LUITPOLD
AP
AP
MYLAN LABS LTD
AP
AP
AP
SAGENT PHARMS
AP
AP
SUN PHARMA GLOBAL
AP
AP
TEVA PHARMS
AP
GEMZAR

AP
+ LILLY
AP
+
GEMCITABINE HYDROCHLORIDE

+ HOSPIRA INC
+
+
GEMFIBROZIL

TABLET;ORAL

GEMFIBROZIL

AB
APOTEX

AB
AUROBINDO PHARMA LTD

AB
BLU CARIBE

AB
DAVA PHARMS INC

AB
HIKMA PHARMS

AB
IMPAX PHARMS

AB
INVAGEN PHARMS

AB
NORTHSTAR HLTHCARE

AB
SUN PHARM INDS INC

0.5%
0.5%

A203189 001 Sep 03, 2014

A202653 001 Aug 28, 2013

0.5%

N022548 001 May 18, 2010

0.3%

N021493 001 Mar 28, 2003

250MG

N206995 001 Jul 13, 2015

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A091594
A091594
A091594
A079160
A079160
A078759
A078759
A091365
A091365
A202997
A202063
A202063
A090799
A090799
A090799
A090242
A204520
A204520
A090663
A090663
A078339
A078339
A079183
A202485
A202485
A202031
A202031
A200145
A200145
A200145
A091597
A091597
A078433
A078433
A077983
A077983

200MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL
200MG BASE/VIAL
1GM BASE/VIAL

001
002
003
001
002
001
002
001
002
001
001
002
001
002
003
003
001
002
001
002
001
002
001
001
002
001
002
001
002
003
001
002
001
002
002
001

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
May
Sep
Sep
Jul
Jul
May
May
Jan
Jan
Sep
Sep
Jul
Jul
Nov
May
May
May
May
Jul
Jul
Jul
May
May
Jul
Jul
Jan
Jan

25,
25,
25,
25,
25,
25,
25,
25,
25,
07,
11,
11,
25,
25,
16,
16,
05,
05,
10,
10,
25,
25,
15,
07,
07,
07,
07,
25,
25,
25,
07,
07,
25,
25,
25,
25,

2011

2011

2011

2011

2011

2011

2011

2011

2011

2013

2012

2012

2011

2011

2011

2011

2016

2016

2012

2012

2011

2011

2010

2013

2013

2013

2013

2011

2011

2011

2013

2013

2011

2011

2011

2011

EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL

N020509 001 May 15, 1996

N020509 002 May 15, 1996

200MG/5.26ML (38MG/ML)
1GM/26.3ML (38MG/ML)
2GM/52.6ML (38MG/ML)

N200795 001 Aug 04, 2011

N200795 002 Aug 04, 2011

N200795 003 Aug 04, 2011

600MG

600MG

600MG

600MG

600MG

600MG

600MG

600MG

600MG

A075034
A202726
A078012
A074270
A078599
A078207
A077836
A079072
A079239

001
001
001
001
001
001
001
001
001

Jul
Sep
Mar
Sep
Aug
Jun
Jul
Sep
Dec

20,
16,
26,
27,
16,
01,
27,
13,
29,

1998

2015

2007

1993

2010

2007

2006

2010

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-178(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GEMFIBROZIL

TABLET;ORAL

GEMFIBROZIL

AB
TEVA
LOPID

AB
+ PFIZER PHARMS
GEMIFLOXACIN MESYLATE

TABLET;ORAL

FACTIVE

AB
+ LG LIFE SCIENCES
GEMIFLOXACIN MESYLATE

AB
ORCHID HLTHCARE

600MG

A074256 001 Oct 31, 1993

600MG

N018422 003 Nov 20, 1986

EQ 320MG BASE

N021158 001 Apr 04, 2003

EQ 320MG BASE

A090466 001 Jun 15, 2015

GENTAMICIN SULFATE

CREAM;TOPICAL

GENTAMICIN SULFATE

AT
+ FOUGERA
EQ 0.1% BASE
AT
PERRIGO NEW YORK
EQ 0.1% BASE
AT
TARO
EQ 0.1% BASE
INJECTABLE;INJECTION

GENTAMICIN SULFATE

AP
FRESENIUS KABI USA
EQ 10MG BASE/ML
AP
+
EQ 40MG BASE/ML
AP
HOSPIRA
EQ 10MG BASE/ML
AP
EQ 10MG BASE/ML
AP
EQ 40MG BASE/ML
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
EQ 1.2MG BASE/ML
AP
EQ 1.6MG BASE/ML
AP
EQ 80MG BASE/100ML
AP
EQ 100MG BASE/100ML
AP
HOSPIRA
EQ 1.2MG BASE/ML
AP
EQ 1.6MG BASE/ML
AP
EQ 80MG BASE/100ML
AP
EQ 100MG BASE/100ML
+ BAXTER HLTHCARE
EQ 2MG BASE/ML
+
EQ 120MG BASE/100ML
OINTMENT;OPHTHALMIC

GENTAMICIN SULFATE

AT
+ AKORN
EQ 0.3% BASE
AT
PERRIGO CO TENNESSEE
EQ 0.3% BASE
OINTMENT;TOPICAL

GENTAMICIN SULFATE

AT
FOUGERA
EQ 0.1% BASE
AT
+ PERRIGO NEW YORK
EQ 0.1% BASE
AT
TARO
EQ 0.1% BASE
SOLUTION/DROPS;OPHTHALMIC

GENOPTIC

AT
ALLERGAN
EQ 0.3% BASE
GENTAK

AT
AKORN
EQ 0.3% BASE
GENTAMICIN SULFATE

AT
AKORN
EQ 0.3% BASE
AT
ALCON RES LTD
EQ 0.3% BASE
AT
+ BAUSCH AND LOMB
EQ 0.3% BASE
AT
PERRIGO CO TENNESSEE
EQ 0.3% BASE
GENTAMICIN SULFATE; PREDNISOLONE ACETATE

OINTMENT;OPHTHALMIC

PRED-G

+ ALLERGAN
EQ 0.3% BASE;0.6%
SUSPENSION/DROPS;OPHTHALMIC

PRED-G

+ ALLERGAN
EQ 0.3% BASE;1%
GLATIRAMER ACETATE

INJECTABLE;SUBCUTANEOUS

COPAXONE

AP
+ TEVA PHARMS USA
GLATOPA

AP
SANDOZ INC
COPAXONE

+ TEVA PHARMS USA

A062531 001 Jul 05, 1984

A062307 001

A062427 001 May 26, 1983

A062366
A062366
A062420
A062612
A062420

002
001
001
004
002

Feb
Aug
Aug
Feb
Aug

06,
04,
15,
20,
15,

1986

1983

1983

1986

1983

A062373
A062373
A062373
A062373
A062414
A062414
A062414
A062414
A062373
A062373

007
008
002
005
001
003
008
010
009
006

Sep
Sep
Sep
Sep
Aug
Aug
Aug
Aug
Sep
Sep

07,
07,
07,
07,
15,
15,
15,
15,
07,
07,

1982

1982

1982

1982

1983

1983

1983

1983

1982

1982

A064093 001 Aug 31, 1995

A065024 001 Jul 30, 2004

A062533 001 Oct 05, 1984

A062351 001 Feb 18, 1982

A062477 001 Dec 23, 1983

A062452 001 Oct 10, 1984

A064163 001 Oct 12, 2001

A062635
A062196
A064048
A065121

001 Jan 08, 1987

001

001 May 11, 1994

001 Jan 30, 2004

N050612 001 Dec 01, 1989

N050586 001 Jun 10, 1988

20MG/ML

N020622 002 Feb 12, 2002

20MG/ML

A090218 001 Apr 16, 2015

40MG/ML

N020622 003 Jan 28, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-179(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GLIMEPIRIDE

TABLET;ORAL

AMARYL

AB
+ SANOFI AVENTIS US
AB
AB
GLIMEPIRIDE
AB
ACCORD HLTHCARE
AB
AB
AB
ACTAVIS LABS FL INC
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
CARLSBAD
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
INDOCO REMEDIES
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
MICRO LABS LTD INDIA
AB
AB
AB
AB
MYLAN
AB
AB
AB
TEVA
AB
AB
AB
VINTAGE
AB
AB
AB
MICRO LABS LTD INDIA

1MG
2MG
4MG

N020496 001 Nov 30, 1995

N020496 002 Nov 30, 1995

N020496 003 Nov 30, 1995

1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
8MG
3MG
6MG

A078181
A078181
A078181
A076995
A076995
A076995
A202759
A202759
A202759
A077911
A077911
A077911
A077091
A077091
A077091
A202112
A202112
A202112
A077295
A077295
A077295
A091220
A091220
A091220
A091220
A077624
A077624
A077624
A076802
A076802
A076802
A077370
A077370
A077370
A077370
A091220
A091220

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

DUETACT

AB
+ TAKEDA PHARMS USA
2MG;30MG

AB
4MG;30MG

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE

AB
SANDOZ
2MG;30MG

AB
4MG;30MG

GLIPIZIDE

TABLET;ORAL

GLIPIZIDE

AB
ACCORD HLTHCARE
AB
AB
ANI PHARMS INC
AB
AB
APOTEX
AB
AB
MYLAN
AB
AB
AB
AB
SANDOZ
AB
AB
SUN PHARM INDS INC
AB
AB
WATSON LABS
AB

5MG

10MG

5MG

10MG

5MG

10MG

5MG

5MG

10MG

10MG

5MG

10MG

5MG

10MG

5MG

10MG

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
004
006
001
002
003
001
002
003
001
002
003
004
003
005

Aug
Aug
Aug
Apr
Apr
Apr
Jun
Jun
Jun
Sep
Sep
Sep
Oct
Oct
Oct
Apr
Apr
Apr
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Nov
Nov
Nov
Oct
Oct
Oct
Dec
Dec
Dec
Dec
Jun
Jun

23,
23,
23,
27,
27,
27,
29,
29,
29,
22,
22,
22,
06,
06,
06,
17,
17,
17,
06,
06,
06,
29,
29,
29,
29,
28,
28,
28,
06,
06,
06,
23,
23,
23,
23,
29,
29,

2007

2007

2007

2010

2010

2010

2012

2012

2012

2009

2009

2009

2005

2005

2005

2013

2013

2013

2005

2005

2005

2012

2012

2012

2012

2005

2005

2005

2005

2005

2005

2005

2005

2005

2005

2012

2012

N021925 001 Jul 28, 2006

N021925 002 Jul 28, 2006

A201049 001 Jan 04, 2013

A201049 002 Jan 04, 2013

A074550
A074550
A074497
A074497
A075795
A075795
A074226
A074438
A074226
A074438
A074305
A074305
A077820
A077820
A074223
A074223

001
002
001
002
001
002
001
001
002
002
001
002
001
002
001
002

Sep
Sep
Aug
Aug
Jun
Jun
May
Jun
May
Jun
Apr
Apr
Jul
Jul
Feb
Feb

11,
11,
31,
31,
13,
13,
10,
20,
10,
20,
07,
07,
11,
11,
27,
27,

1997

1997

1995

1995

2001

2001

1994

1995

1994

1995

1995

1995

2006

2006

1995

1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-180(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GLIPIZIDE

TABLET;ORAL

GLUCOTROL

AB
PFIZER
5MG

AB
+
10MG

TABLET, EXTENDED RELEASE;ORAL

GLIPIZIDE

AB
MYLAN PHARMS INC
2.5MG

AB
5MG

AB
10MG

AB
PAR PHARM
5MG

AB
10MG

AB
WATSON LABS
2.5MG

AB
5MG

AB
10MG

GLUCOTROL XL

AB
PFIZER
2.5MG
AB
5MG
AB
+
10MG

N017783 001 May 08, 1984

N017783 002 May 08, 1984

A202298
A202298
A202298
A076159
A076159
A076467
A076467
A076467

001
002
003
002
001
003
001
002

May
May
May
Sep
Sep
Mar
Sep
Nov

19,
19,
19,
20,
20,
27,
08,
07,

2015

2015

2015

2013

2013

2006

2003

2003

N020329 003 Aug 10, 1999

N020329 001 Apr 26, 1994

N020329 002 Apr 26, 1994

GLIPIZIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

AB
COREPHARMA
2.5MG;250MG

AB
2.5MG;500MG

AB
5MG;500MG

AB
HERITAGE PHARMS INC
2.5MG;250MG

AB
2.5MG;500MG

AB
5MG;500MG

AB
MYLAN
2.5MG;250MG

AB
2.5MG;500MG

AB
5MG;500MG

AB
SUN PHARM INDS INC
2.5MG;250MG

AB
2.5MG;500MG

AB
5MG;500MG

AB
TEVA PHARMS
2.5MG;250MG

AB
2.5MG;500MG

AB
+
5MG;500MG

AB
ZYDUS PHARMS USA INC
2.5MG;250MG

AB
2.5MG;500MG

AB

5MG;500MG

A077507
A077507
A077507
A078728
A078728
A078728
A078083
A078083
A078083
A077620
A077620
A077620
A077270
A077270
A077270
A078905
A078905
A078905

GLUCAGON HYDROCHLORIDE

POWDER;INTRAMUSCULAR, INTRAVENOUS

GLUCAGON

+ FRESENIUS KABI USA
EQ 1MG BASE/VIAL

N201849 001 May 08, 2015

GLUCAGON HYDROCHLORIDE RECOMBINANT

INJECTABLE;INJECTION

GLUCAGEN

+ NOVO NORDISK

EQ 1MG BASE/VIAL

N020918 001 Jun 22, 1998

GLUCAGON RECOMBINANT

INJECTABLE;INJECTION

GLUCAGON

+ LILLY

1MG/VIAL

N020928 001 Sep 11, 1998

GLUTAMINE

FOR SOLUTION;ORAL

NUTRESTORE

+ EMMAUS MEDCL

5GM/PACKET

N021667 001 Jun 10, 2004

GLYBURIDE

TABLET;ORAL

GLYBURIDE (MICRONIZED)

AB
DAVA PHARMS INC
AB
AB
AB
AB
HIKMA
AB
AB
AB
MYLAN
AB
AB

1.5MG

3MG

4.5MG

6MG

1.5MG

3MG

6MG

1.5MG

3MG

6MG

A074591
A074591
A074591
A074591
A075890
A075890
A075890
A074792
A074792
A074792

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

001
002
003
004
001
002
003
001
002
003

Oct
Oct
Oct
Jun
Jun
Jun
Apr
Apr
Apr
Jan
Jan
Jan
Oct
Oct
Oct
Jan
Jan
Jan

Dec
Dec
Dec
Dec
Jul
Jul
Jul
Jun
Jun
Aug

27,
27,
27,
23,
23,
23,
12,
12,
12,
11,
11,
11,
28,
28,
28,
31,
31,
31,

22,
22,
22,
22,
31,
31,
31,
26,
26,
17,

2005

2005

2005

2010

2010

2010

2007

2007

2007

2008

2008

2008

2005

2005

2005

2011

2011

2011

1997

1997

1997

1997

2003

2003

2003

1998

1998

1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-181(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GLYBURIDE

TABLET;ORAL

GLYBURIDE (MICRONIZED)

AB
TEVA
AB
AB
AB
GLYNASE

AB
PHARMACIA AND UPJOHN
AB
AB
+
GLYBURIDE

AB1
AUROBINDO PHARMA
AB1
AB1
AB1
COREPHARMA
AB1
AB1
AB1
HERITAGE PHARMS INC
AB1
AB1
AB1
TEVA
AB1
AB1 +
DIABETA

AB2
SANOFI AVENTIS US
AB2
AB2 +
GLYBURIDE

AB2
COREPHARMA
AB2
AB2

1.5MG
3MG
4.5MG
6MG

A074686
A074686
A074686
A074686

001
002
003
004

1.5MG
3MG
6MG

N020051 001 Mar 04, 1992

N020051 002 Mar 04, 1992

N020051 004 Sep 24, 1993

1.25MG
2.5MG
5MG
1.25MG
2.5MG
5MG
1.25MG
2.5MG
5MG
1.25MG
2.5MG
5MG

A077537
A077537
A077537
A076257
A076257
A076257
A090937
A090937
A090937
A074388
A074388
A074388

1.25MG
2.5MG
5MG

N017532 001 May 01, 1984

N017532 002 May 01, 1984

N017532 003 May 01, 1984

1.25MG
2.5MG
5MG

A206079 001 Sep 30, 2015

A206079 002 Sep 30, 2015

A206079 003 Sep 30, 2015

001
002
003
001
002
003
001
002
003
001
002
003

Apr
Apr
Apr
Apr

Oct
Oct
Oct
Jun
Jun
Jun
Feb
Feb
Feb
Aug
Aug
Aug

20,
20,
20,
20,

18,
18,
18,
27,
27,
27,
28,
28,
28,
29,
29,
29,

1999

1999

1999

1999

2007

2007

2007

2002

2002

2002

2011

2011

2011

1995

1995

1995

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLUCOVANCE

AB
+ BRISTOL MYERS SQUIBB
2.5MG;500MG
AB
5MG;500MG
GLYBURIDE AND METFORMIN HYDROCHLORIDE

AB
ACTAVIS ELIZABETH
1.25MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
AB
AUROBINDO PHARMA
1.25MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
AB
COREPHARMA
1.25MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
AB
HERITAGE PHARMS INC
1.25MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
AB
IVAX SUB TEVA PHARMS
1.25MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG

A076716
A076716
A076716
A077870
A077870
A077870
A076731
A076731
A076731
A079009
A079009
A079009
A076345
A076345
A076345

GLYCEROL PHENYLBUTYRATE

LIQUID;ORAL

RAVICTI

+ HORIZON THERAPS INC

N203284 001 Feb 01, 2013

1.1GM/ML

GLYCINE

SOLUTION;IRRIGATION

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
1.5GM/100ML
GLYCINE 1.5% IN PLASTIC CONTAINER

AT
B BRAUN
1.5GM/100ML
AT
HOSPIRA
1.5GM/100ML

N021178 002 Jul 31, 2000

N021178 003 Jul 31, 2000

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

N017865 001

N016784 001

N018315 001

Jun
Jun
Jun
Nov
Nov
Nov
Nov
Nov
Nov
Jun
Jun
Jun
Feb
Feb
Feb

28,
28,
28,
14,
14,
14,
19,
19,
19,
03,
03,
03,
18,
18,
18,

2005

2005

2005

2007

2007

2007

2004

2004

2004

2009

2009

2009

2004

2004

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-182(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GLYCOPYRROLATE

INJECTABLE;INJECTION

GLYCOPYRROLATE

AP
HIKMA FARMACEUTICA
AP
LUITPOLD
ROBINUL

AP
+ EUROHLTH INTL SARL
POWDER;INHALATION

SEEBRI

+ NOVARTIS PHARMS CORP
SOLUTION;ORAL

CUVPOSA

+ MERZ PHARMS
TABLET;ORAL

GLYCOPYRROLATE

AA
AUROLIFE PHARMA LLC
AA
DR REDDYS LABS LTD
AA
AA
LEADING PHARMA LLC
AA
AA
NEXGEN PHARMA
AA
PAR PHARM
AA
AA
STASON PHARMS
AA
AA
SUN PHARM INDS LTD
AA
AA
VINTAGE
AA
AA
VINTAGE PHARMS
AA
ROBINUL

AA
+ SHIONOGI INC
ROBINUL FORTE

AA
+ SHIONOGI INC

0.2MG/ML
0.2MG/ML

A090963 001 Sep 21, 2011

A089335 001 Jul 23, 1986

0.2MG/ML

N017558 001

15.6MCG/INH

N207923 001 Oct 29, 2015

1MG/5ML

N022571 001 Jul 28, 2010

1MG
1MG
2MG
1MG
2MG
1.5MG
1MG
2MG
1MG
2MG
1MG
2MG
1MG
2MG
1MG
2MG

A202675
A040847
A040847
A090195
A090195
A091522
A040653
A040653
A091182
A091182
A040844
A040844
A040821
A040821
A090020
A090020

1MG

N012827 001

2MG

N012827 002

GLYCOPYRROLATE ; INDACATEROL MALEATE

POWDER;INHALATION

UTIBRON

+ NOVARTIS PHARMS CORP
15.6MCG/INH;27.5MCG/INH
GONADOTROPIN, CHORIONIC

INJECTABLE;INJECTION

CHORIONIC GONADOTROPIN

AP
+ FERRING
AP
+ FRESENIUS KABI USA
PREGNYL

AP
+ ORGANON USA INC
GOSERELIN ACETATE

IMPLANT;IMPLANTATION

ZOLADEX

+ ASTRAZENECA
+

001
001
002
001
002
001
001
002
001
002
001
002
001
002
001
002

Apr
Mar
Mar
Sep
Sep
Mar
Aug
Aug
Feb
Feb
Aug
Aug
Dec
Dec
Oct
Oct

15,
21,
21,
21,
21,
12,
31,
31,
03,
03,
18,
18,
29,
29,
19,
19,

2013

2008

2008

2012

2012

2012

2006

2006

2014

2014

2009

2009

2008

2008

2011

2011

N207930 001 Oct 29, 2015

10,000 UNITS/VIAL
10,000 UNITS/VIAL

N017016 007

N017067 002

10,000 UNITS/VIAL

N017692 001

EQ 3.6MG BASE
EQ 10.8MG BASE

N019726 001 Dec 29, 1989

N020578 001 Jan 11, 1996

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

AT
+ BAUSCH AND LOMB
0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML

AT
LUITPOLD
0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML

NEOSPORIN

AT
+ MONARCH PHARMS
0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML

GRANISETRON

FILM, EXTENDED RELEASE;TRANSDERMAL

SANCUSO

+ PROSTRAKAN INC
3.1MG/24HR

A064047 001 Jan 31, 1996

A065187 001 Oct 28, 2005

A060582 001

N022198 001 Sep 12, 2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-183(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION

GRANISETRON HYDROCHLORIDE

AP
AKORN INC
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
BANNER LIFE SCIENCES
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
BEDFORD LABS
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
CIPLA LTD
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
EUROHLTH INTL SARL
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
FRESENIUS KABI USA
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
LUITPOLD
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
SAGENT AGILA
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
SAGENT STRIDES
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
SANDOZ
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
SANDOZ INC
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
+ TEVA PHARMS USA
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
+
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
+
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP
WOCKHARDT USA
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

AP
BANNER LIFE SCIENCES
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP
+ FRESENIUS KABI USA

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

GRANISTERON HYDROCHLORIDE

AP
HIKMA FARMACEUTICA

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

TABLET;ORAL

GRANISETRON HYDROCHLORIDE

AB
APOTEX INC
EQ 1MG BASE

AB
CIPLA LTD
EQ 1MG BASE

AB
COREPHARMA
EQ 1MG BASE

AB
DR REDDYS LABS LTD
EQ 1MG BASE

AB
MYLAN
EQ 1MG BASE

AB
NATCO PHARMA
EQ 1MG BASE

AB
ORCHID HLTHCARE
EQ 1MG BASE

AB
ROXANE
EQ 1MG BASE

AB
TARO
EQ 1MG BASE

AB
+ TEVA PHARMS
EQ 1MG BASE

GRISEOFULVIN, MICROSIZE

SUSPENSION;ORAL

GRISEOFULVIN

AB
+ ACTAVIS MID ATLANTIC

AB
IVAX SUB TEVA PHARMS

AB
PERRIGO CO TENNESSEE

AB
VINTAGE PHARMS

TABLET;ORAL

GRISEOFULVIN

AB
+ SANDOZ INC

AB
SIGMAPHARM LABS LLC

SANDOZ INC

A079119
A079078
A079078
A078863
A078880
A077913
A077186
A077187
A078262
A078258
A078258
A077177
A078522
A078090
A091274
A091137
A091136
A091136
A078534
A078531
A078531
A078835
A078835
A078392
A077963
A077297
A078566
A078564
A078565

001
001
002
001
001
001
001
001
001
001
002
001
001
001
001
002
001
002
001
001
002
001
002
001
001
001
001
001
001

Sep
Sep
Sep
Jun
Jun
Jun
Jun
Jun
Dec
Jun
Jun
Dec
Dec
Jun
Sep
Apr
Apr
Apr
Apr
Apr
Apr
Jun
Jun
Dec
Jan
Jun
Feb
Jun
Jun

10,
14,
14,
30,
30,
26,
30,
30,
31,
30,
30,
31,
31,
30,
22,
09,
09,
09,
30,
30,
30,
30,
30,
31,
03,
30,
29,
30,
30,

2009

2009

2009

2008

2008

2008

2008

2008

2007

2008

2008

2007

2007

2008

2010

2010

2010

2010

2009

2009

2009

2008

2008

2007

2008

2008

2008

2008

2008

A078863 002 Jun 30, 2008

A078096 001 Jun 30, 2008

A078629 001 Dec 23, 2009

A078629 002 Dec 23, 2009

A078843
A078037
A078260
A078846
A078725
A078969
A078678
A077842
A090817
A078080

001
001
001
001
001
001
001
001
001
001

Feb
Feb
Dec
Feb
Jan
Jun
Feb
Dec
May
Dec

27,
27,
31,
27,
30,
22,
13,
31,
28,
31,

2008

2008

2007

2009

2008

2009

2008

2007

2010

2007

125MG/5ML

125MG/5ML

125MG/5ML

125MG/5ML

A065394
A065354
A065200
A065438

001
001
001
001

Jul
Sep
Mar
Oct

06,
10,
02,
08,

2007

2007

2005

2010

500MG

500MG

250MG

A091592 002 Aug 07, 2013

A202482 001 Oct 22, 2012

A091592 001 Aug 07, 2013

GRISEOFULVIN, ULTRAMICROSIZE

TABLET;ORAL

GRIS-PEG

AB
VALEANT PHARMS INC

125MG

AB
+

250MG

GRISEOFULVIN, ULTRAMICROSIZE
AB
RICONPHARMA LLC
125MG
AB
250MG

N050475 001

N050475 002

A204371 001 Jan 09, 2014

A204371 002 Jan 09, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-184(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GRISEOFULVIN, ULTRAMICROSIZE

TABLET;ORAL

GRISEOFULVIN,ULTRAMICROSIZE

AB
SIGMAPHARM LABS LLC
125MG

AB
250MG

A202545 001 Oct 22, 2012

A202545 002 Oct 22, 2012

GUAIFENESIN; HYDROCODONE BITARTRATE

SOLUTION;ORAL

FLOWTUSS

MISSION PHARMACAL CO
200MG/5ML;2.5MG/5ML

OBREDON

+ SOVEREIGN PHARMS
200MG/5ML;2.5MG/5ML

N022424 001 May 14, 2015

N205474 001 Nov 14, 2014

GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

HYCOFENIX

+ MIKART INC

200MG/5ML;2.5MG/5ML;30MG/5ML

N022279 001 May 14, 2015

GUANABENZ ACETATE

TABLET;ORAL

GUANABENZ ACETATE

ANI PHARMS INC

+

A074149 001 Apr 07, 1995

A074149 002 Apr 07, 1995

EQ 4MG BASE

EQ 8MG BASE

GUANFACINE HYDROCHLORIDE

TABLET;ORAL

GUANFACINE HYDROCHLORIDE
AB
AMNEAL PHARM
EQ
AB
EQ
AB
EPIC PHARMA LLC
EQ
AB
EQ
AB
MYLAN
EQ
AB
EQ
AB
WATSON LABS
EQ
AB
EQ
TENEX
AB
PROMIUS PHARMA
EQ
AB
+
EQ
TABLET, EXTENDED RELEASE;ORAL

GUANFACINE HYDROCHLORIDE

AB
ACTAVIS ELIZABETH

EQ
AB

EQ
AB

EQ
AB

EQ
AB
IMPAX LABS INC

EQ
AB

EQ
AB

EQ
AB

EQ
AB
MYLAN PHARMS INC

EQ
AB

EQ
AB

EQ
AB

EQ
AB
SANDOZ INC

EQ
AB

EQ
AB

EQ
AB

EQ
AB
TEVA PHARMS USA

EQ
AB

EQ
AB

EQ
AB

EQ
AB
TWI PHARMS INC

EQ
AB

EQ
AB

EQ
AB

EQ
INTUNIV

AB
SHIRE

EQ
AB

EQ
AB

EQ
AB
+

EQ

1MG
2MG
1MG
2MG
1MG
2MG
1MG
2MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A075109
A075109
A074673
A074673
A074796
A074796
A074145
A074145

001
002
001
002
001
002
001
002

Nov
Nov
Feb
Feb
Jan
Jan
Oct
Oct

25,
25,
28,
28,
27,
27,
17,
17,

1998

1998

1997

1997

1997

1997

1995

1995

1MG BASE

2MG BASE

N019032 001 Oct 27, 1986

N019032 002 Nov 07, 1988

1MG
2MG
3MG
4MG
1MG
2MG
3MG
4MG
1MG
2MG
3MG
4MG
1MG
2MG
3MG
4MG
1MG
2MG
3MG
4MG
1MG
2MG
3MG
4MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A200881
A200881
A200881
A200881
A202238
A202238
A202238
A202238
A202578
A202578
A202578
A202578
A202568
A202568
A202568
A202568
A201382
A201382
A201382
A201382
A201408
A201408
A201408
A201408

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

05,
05,
05,
05,
20,
20,
20,
20,
02,
02,
02,
02,
03,
03,
03,
03,
02,
02,
02,
02,
02,
02,
02,
02,

2012

2012

2012

2012

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

1MG
2MG
3MG
4MG

BASE

BASE

BASE

BASE

N022037
N022037
N022037
N022037

001
002
003
004

Sep
Sep
Sep
Sep

02,
02,
02,
02,

2009

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-185(of 388)

PRESCRIPTION DRUG PRODUCT LIST

GUANIDINE HYDROCHLORIDE

TABLET;ORAL

GUANIDINE HYDROCHLORIDE

MERCK SHARP DOHME

HALCINONIDE

CREAM;TOPICAL

HALOG

+ RANBAXY

OINTMENT;TOPICAL

HALOG

+ RANBAXY

HALOBETASOL PROPIONATE

CREAM;TOPICAL

HALOBETASOL PROPIONATE

AB
FOUGERA PHARMS

AB
G AND W LABS

AB
PERRIGO ISRAEL

AB
TARO

ULTRAVATE

AB
+ RANBAXY

LOTION;TOPICAL

ULTRAVATE

+ FERNDALE LABS INC

OINTMENT;TOPICAL

HALOBETASOL PROPIONATE

AB
G AND W LABS

AB
PERRIGO

AB
TARO

ULTRAVATE

AB
+ RANBAXY

HALOPERIDOL

TABLET;ORAL

HALOPERIDOL

AB
MYLAN

AB

AB

AB

AB

AB

AB
SANDOZ

AB

AB
+

AB

AB

AB

AB
ZYDUS PHARMS USA

AB

AB

HALOPERIDOL DECANOATE

INJECTABLE;INJECTION

HALDOL

AO
+ JANSSEN PHARMS

AO
+

HALOPERIDOL DECANOATE

AO
EUROHLTH INTL SARL

AO

AO
FRESENIUS KABI USA

AO

AO
MYLAN LABS LTD

AO

AO
TEVA PHARMS USA

AO

HALOPERIDOL LACTATE

CONCENTRATE;ORAL

HALOPERIDOL

AA
PHARM ASSOC

AA
SILARX

AA
+ TEVA PHARMS

125MG

N001546 001

0.1%

N017556 001

0.1%

N017824 001

0.05%

0.05%

0.05%

0.05%

A077001
A078162
A077123
A077227

0.05%

N019967 001 Dec 27, 1990

0.05%

N208183 001 Nov 06, 2015

0.05%

0.05%

0.05%

A077721 001 Sep 07, 2006

A076872 001 Dec 16, 2004

A076994 001 Dec 16, 2004

0.05%

N019968 001 Dec 17, 1990

0.5MG

1MG

2MG

5MG

10MG

20MG

0.5MG

1MG

2MG

5MG

10MG

20MG

5MG

10MG

20MG

A070278
A070278
A070278
A070278
A070278
A070278
A071206
A071207
A071208
A071209
A071210
A071211
A077580
A077580
A077580

EQ 50MG BASE/ML

EQ 100MG BASE/ML

N018701 001 Jan 14, 1986

N018701 002 Jan 31, 1997

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A074811
A075305
A074893
A074893
A075440
A075440
A075393
A075393

50MG BASE/ML

100MG BASE/ML

50MG BASE/ML

100MG BASE/ML

50MG BASE/ML

100MG BASE/ML

50MG BASE/ML

100MG BASE/ML

EQ 2MG BASE/ML

EQ 2MG BASE/ML

EQ 2MG BASE/ML

001
001
001
001

006
004
001
005
002
003
001
001
001
001
001
001
003
004
005

001
001
001
002
001
002
001
002

Dec
Apr
Dec
Aug

Jun
Jun
Jun
Jun
Jul
Jul
Nov
Nov
Nov
Nov
Mar
Mar
Nov
Nov
Nov

Jan
Sep
Dec
Dec
Feb
Feb
May
May

16,
24,
16,
04,

10,
10,
10,
10,
16,
16,
17,
17,
17,
17,
11,
11,
29,
29,
29,

30,
28,
19,
19,
28,
28,
11,
11,

2004

2007

2004

2005

1986

1986

1986

1986

2009

2009

1986

1986

1986

1986

1988

1988

2007

2007

2007

1998

1998

1997

1997

2000

2000

1999

1999

A073037 001 Feb 26, 1993

A073364 001 Sep 28, 1993

A071617 001 Dec 01, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-186(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HALOPERIDOL LACTATE

INJECTABLE;INJECTION

HALDOL

AP
+ JANSSEN PHARMS
HALOPERIDOL

AP
EUROHLTH INTL SARL
AP
FRESENIUS KABI USA
AP
GLAND PHARMA LTD
AP
MYLAN LABS LTD
AP
SAGENT PHARMS
AP
AP
TEVA PHARMS USA

EQ 5MG BASE/ML

N015923 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ

A075858
A075689
A076774
A078347
A091637
A200742
A076035

5MG
5MG
5MG
5MG
5MG
5MG
5MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM

AP
+ EUROHLTH INTL SARL
1,000 UNITS/ML
N017037
AP
+
5,000 UNITS/ML
N017037
AP
+
10,000 UNITS/ML
N017037
AP
+ FRESENIUS KABI USA
1,000 UNITS/ML
N017029
AP
+
5,000 UNITS/ML
N017651
AP
+
10,000 UNITS/ML
N017029
AP
+
20,000 UNITS/ML
N017029
AP
HOSPIRA INC
1,000 UNITS/ML
A090571
AP
5,000 UNITS/ML
A090571
AP
10,000 UNITS/ML
A090571
AP
SAGENT PHARMS
1,000 UNITS/ML
A090808
AP
5,000 UNITS/ML
A090808
AP
10,000 UNITS/ML
A090808
AP
20,000 UNITS/ML
A090809
AP
SANDOZ
1,000 UNITS/ML
A091682
AP
5,000 UNITS/ML
A091659
AP
5,000 UNITS/ML
A091682
AP
10,000 UNITS/ML
A201002
AP
SHENZHEN TECHDOW
1,000 UNITS/ML
A202957
AP
5,000 UNITS/ML
A202733
AP
5,000 UNITS/ML
A202957
AP
10,000 UNITS/ML
A203198
AP
20,000 UNITS/ML
A203198
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
200 UNITS/100ML
N018609
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
+ B BRAUN
200 UNITS/100ML
N019953
AP
HOSPIRA
200 UNITS/100ML
N018916
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
HOSPIRA
10,000 UNITS/100ML
N019339
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
200 UNITS/100ML
N018609
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
HOSPIRA
200 UNITS/100ML
N018916
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ B BRAUN
4,000 UNITS/100ML
N019952
AP
HOSPIRA
4,000 UNITS/100ML
N019805
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ B BRAUN
5,000 UNITS/100ML
N019952
AP
+
10,000 UNITS/100ML
N019952
5,000 UNITS/100ML
N019339
AP
HOSPIRA
AP
5,000 UNITS/100ML
N019805
AP
10,000 UNITS/100ML
N019339
HEPARIN SODIUM IN PLASTIC CONTAINER

AP
+ FRESENIUS KABI USA
1,000 UNITS/ML
N017029
AP
+
5,000 UNITS/ML
N017029
AP
+
10,000 UNITS/ML
N017029
AP
+
20,000 UNITS/ML
N017029
HEPARIN SODIUM PRESERVATIVE FREE

AP
+ FRESENIUS KABI USA
1,000 UNITS/ML
N017029
AP
SAGENT PHARMS
1,000 UNITS/ML
A090810
AP
SHENZHEN TECHDOW
1,000 UNITS/ML
A202732
HEPARIN SODIUM

+ FRESENIUS KABI USA
10,000 UNITS/ML
N017029
+ HOSPIRA
5,000 UNITS/ML
A088100
+ PFIZER
1,000 UNITS/ML
N201370
+
5,000 UNITS/ML
N201370

001
001
001
001
001
001
001

Jun
Mar
Aug
Sep
Sep
Sep
Aug

18,
09,
25,
14,
02,
02,
29,

2001

2001

2004

2009

2011

2011

2001

001

002

003

001

006

003

004

001
002
003
001
002
003
001
001
001
002
001
001
001
002
001
002

Aug
Aug
Aug
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

31,
31,
31,
30,
30,
30,
30,
08,
08,
08,
08,
12,
12,
12,
12,
12,

2009

2009

2009

2010

2010

2010

2010

2011

2011

2011

2011

2014

2014

2014

2014

2014

001 Apr 28, 1982

001 Jul 20, 1992

010 Jun 23, 1989

003 Mar 27, 1985

002 Apr 28, 1982

011 Jun 23, 1989

001 Jul 20, 1992

001 Jan 25, 1989

004
005
004
002
002

Jul
Jul
Mar
Jan
Mar

20,
20,
27,
25,
27,

1992

1992

1985

1989

1985

013
014
015
016

Dec
Dec
Dec
Dec

05,
05,
05,
05,

1985

1985

1985

1985

010 Apr 28, 1986

001 Jun 30, 2010

001 Jun 12, 2014

020
001
001
002

Mar
Apr
Jul
Jul

31,
28,
21,
21,

2011

1983

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-187(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM

+
10,000 UNITS/ML
N201370
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA
5,000 UNITS/100ML
N019339
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

HOSPIRA
5,000 UNITS/100ML
N018916
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

HOSPIRA
5,000 UNITS/100ML
N018916
10,000 UNITS/100ML
N018916
HEPARIN SODIUM PRESERVATIVE FREE

+ FRESENIUS KABI USA
10,000 UNITS/ML
N017029
+ HOSPIRA
10,000 UNITS/ML
A089522
+ PFIZER
1,000 UNITS/ML
N201370
HEXACHLOROPHENE

EMULSION;TOPICAL

PHISOHEX

+ SANOFI AVENTIS US
SPONGE;TOPICAL

PRE-OP

AT
+ DAVIS AND GECK
PRE-OP II

AT
DAVIS AND GECK

007 Jan 31, 1984

008 Jan 31, 1984

019 Nov 22, 2010

001 May 04, 1987

004 Jul 21, 2011

480MG

N017433 001

480MG

N017433 002

N022555 001 May 28, 2010

50MG

N022058 001 May 03, 2007

50MG

N021732 001 Oct 12, 2004

A088017 001 Jul 05, 1983

A040613 001 Feb 08, 2008

A088008 001 Mar 03, 1983

A091528 001 Apr 20, 2011

A088508 001 Jul 30, 1985

150 UNITS/ML

N021665 001 Oct 26, 2004

200 UNITS/VIAL

N021640 002 Dec 02, 2004

HYALURONIDASE RECOMBINANT HUMAN

INJECTABLE;INJECTION

HYLENEX RECOMBINANT

+ HALOZYME THERAP
150 UNITS/ML
HYDRALAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

HYDRALAZINE HYDROCHLORIDE

AP
+ AKORN
AP
FRESENIUS KABI USA
AP
LUITPOLD
AP
NAVINTA LLC
AP
X-GEN PHARMS INC
TABLET;ORAL

HYDRALAZINE HYDROCHLORIDE

AA
ACTAVIS GRP PTC
AA
AA
AA

006 Jan 31, 1984

N006882 001

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP;ORAL

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

AA
ACTAVIS MID ATLANTIC
1.5MG/5ML;5MG/5ML
AA
+ HI TECH PHARMA
1.5MG/5ML;5MG/5ML
AA
WOCKHARDT
1.5MG/5ML;5MG/5ML
TABLET;ORAL

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

AA
NOVEL LABS INC
1.5MG;5MG
TUSSIGON

AA
+ KING PHARMS
1.5MG;5MG
HYALURONIDASE

INJECTABLE;INJECTION

AMPHADASE

+ AMPHASTAR PHARM
VITRASE

+ BAUSCH AND LOMB

001 Mar 27, 1985

3%

HEXAMINOLEVULINATE HYDROCHLORIDE

FOR SOLUTION;INTRAVESICAL

CYSVIEW KIT

+ PHOTOCURE ASA
100MG/VIAL
HISTRELIN ACETATE

IMPLANT;SUBCUTANEOUS

SUPPRELIN LA

+ ENDO PHARM
VANTAS

+ ENDO PHARM

003 Jul 21, 2011

N021859 001 Dec 02, 2005

20MG/ML
20MG/ML
20MG/ML
20MG/ML
20MG/ML

A040730
A040388
A040136
A202938
A203110

001
001
001
001
001

Apr
Mar
Jun
Mar
Jun

21,
13,
30,
28,
29,

2009

2001

1997

2013

2015

10MG
25MG
50MG
100MG

A091679
A091679
A091679
A091679

001
002
003
004

Mar
Mar
Mar
Mar

04,
04,
04,
04,

2013

2013

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-188(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL

HYDRALAZINE HYDROCHLORIDE

AA
ALKEM LABS LTD
AA
AA
AA
AA
CADILA PHARMS LTD
AA
AA
AA
GLENMARK PHARMS LTD
AA
AA
AA
AA
HERITAGE PHARMS INC
AA
AA
AA
AA
HETERO LABS LTD III
AA
AA
AA
AA
INVAGEN PHARMS
AA
AA
AA
AA
MYLAN
AA
AA
AA
AA
PAR PHARM
AA
AA
AA
AA
+ PLIVA
AA
+
AA
+
AA
+
AA
STRIDES PHARMA
AA
AA

10MG
25MG
50MG
100MG
25MG
50MG
100MG
10MG
25MG
50MG
100MG
10MG
25MG
50MG
100MG
10MG
25MG
50MG
100MG
10MG
25MG
50MG
100MG
10MG
25MG
50MG
100MG
10MG
25MG
50MG
100MG
10MG
25MG
50MG
100MG
25MG
50MG
100MG

A200737
A200737
A200737
A200737
A203845
A203845
A203845
A090527
A090527
A090527
A090527
A086242
A086242
A086242
A086242
A040901
A040901
A040901
A040901
A090255
A090255
A090255
A090255
A090413
A090413
A090413
A090413
A087836
A086961
A086962
A088391
A089097
A088467
A088468
A089098
A200770
A200770
A200770

001
002
003
004
001
002
003
001
002
003
004
001
003

002

004
001
002
003
004
001
002
003
004
001
002
003
004
001
002

001

001
001
001
001
001
001
002
003

Dec
Dec
Dec
Dec
Sep
Sep
Sep
May
May
May
May
Feb

07,
07,
07,
07,
18,
18,
18,
27,
27,
27,
27,
04,

2012

2012

2012

2012

2014

2014

2014

2009

2009

2009

2009

2010

Feb
Sep
Sep
Sep
Sep
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Oct

04,
12,
12,
12,
12,
15,
15,
15,
15,
08,
08,
08,
08,
05,

2010

2008

2008

2008

2008

2008

2008

2008

2008

2010

2010

2010

2010

1982

Sep
Dec
May
May
Dec
May
May
May

27,
18,
01,
01,
18,
03,
03,
03,

1983

1985

1984

1984

1985

2013

2013

2013

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDRA-ZIDE

PAR PHARM
25MG;25MG
+
50MG;50MG

A088957 001 Oct 21, 1985

A088946 001 Oct 21, 1985

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

TABLET;ORAL

BIDIL

+ ARBOR PHARMS LLC
37.5MG;20MG

N020727 001 Jun 23, 2005

HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDROCHLOROTHIAZIDE

AB
ALEMBIC PHARMS LTD
AB
APOTEX
AB
AUROBINDO PHARMA
AB
IPCA LABS LTD
AB
IVAX SUB TEVA PHARMS
AB
JUBILANT CADISTA
AB
LANNETT HOLDINGS INC
AB
MYLAN
AB
SUN PHARM INDS INC
AB
UNICHEM
AB
VINTAGE PHARMS
MICROZIDE

AB
+ ACTAVIS LABS UT INC
TABLET;ORAL

HYDROCHLOROTHIAZIDE

AB
ACCORD HLTHCARE
AB
AB

12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG

A200645
A078389
A078164
A079237
A077005
A078391
A091662
A075640
A090651
A090510
A075907

001
001
001
001
001
001
001
001
001
001
001

12.5MG

N020504 001 Dec 27, 1996

12.5MG
25MG
50MG

A202556 001 Sep 24, 2012

A202556 002 Sep 24, 2012

A202556 003 Sep 24, 2012

Nov
May
Sep
Apr
Jul
Feb
Jan
Jan
Apr
Jan
Sep

30,
16,
18,
02,
13,
11,
27,
28,
07,
19,
17,

2010

2008

2007

2009

2005

2008

2012

2000

2014

2010

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-189(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE

TABLET;ORAL

HYDROCHLOROTHIAZIDE

AB
ACTAVIS ELIZABETH
AB
APOTEX
AB
AB
AUROBINDO PHARMA
AB
AB
DAVA PHARMS INC
AB
AB
HERITAGE PHARMS INC
AB
AB
HIKMA PHARMS LLC
AB
IPCA LABS LTD
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
+
AB
JUBILANT CADISTA
AB
AB
LANNETT
AB
AB
LEADING PHARMA LLC
AB
AB
MYLAN PHARMS INC
AB
AB
AB
SCIEGEN PHARMS INC
AB
AB
SUN PHARM INDS INC
AB
AB
AB
UNICHEM
AB
AB
VINTAGE PHARMS
AB
ORETIC

AB
ABBVIE

12.5MG

25MG

50MG

25MG

50MG

25MG

50MG

25MG

50MG

50MG

12.5MG

25MG

50MG

25MG

50MG

25MG

50MG

25MG

50MG

25MG

50MG

12.5MG

25MG

50MG

25MG

50MG

12.5MG

25MG

50MG

25MG

50MG

25MG

50MG

A040707
A040774
A040774
A040780
A040780
A087059
A087068
A085182
A085182
A084878
A040807
A040807
A040807
A083177
A083177
A040809
A040809
A084325
A084324
A040702
A040702
A040770
A040735
A040735
A203018
A203018
A040857
A040810
A040810
A040907
A040907
A040412
A040412

50MG

N011971 002

HYDROCHLOROTHIAZIDE; IRBESARTAN

TABLET;ORAL

AVALIDE

12.5MG;150MG

AB
+ SANOFI AVENTIS US

12.5MG;300MG

AB
+

IRBESARTAN AND HYDROCHLOROTHIAZIDE

AB
ALEMBIC LTD
12.5MG;150MG

AB
12.5MG;300MG

AB
APOTEX INC
12.5MG;150MG

AB
12.5MG;300MG

AB
AUROBINDO PHARMA LTD
12.5MG;150MG

AB
12.5MG;300MG

AB
DR REDDYS LABS LTD
12.5MG;150MG

AB
12.5MG;300MG

AB
LUPIN LTD
12.5MG;150MG

AB
12.5MG;300MG

AB
MACLEODS PHARMS LTD
12.5MG;150MG

AB
12.5MG;300MG

AB
MYLAN PHARMS INC
12.5MG;150MG

AB
12.5MG;300MG

AB
PRINSTON INC
12.5MG;150MG

AB
12.5MG;300MG

AB
ROXANE
12.5MG;150MG

AB
12.5MG;300MG

AB
SANDOZ
12.5MG;150MG

AB
12.5MG;300MG

AB
TEVA
12.5MG;150MG

AB
12.5MG;300MG

AB
WATSON LABS INC
12.5MG;150MG

AB
12.5MG;300MG

001
001
002
001
002
001

001

002

001

001

001
002
003
001

002

001
002
001

001

001
002
001
002
003
001
002
001
001
002
001
002
001
002

Feb
Oct
Oct
Jul
Jul

27,
03,
03,
20,
20,

2007

2007

2007

2007

2007

Jul 20, 2007

Jul 20, 2007

Jul 20, 2007

Sep 04, 2007

Sep 04, 2007

Mar
Mar
Jan
Jan
Jan
Jul
Jul
May
Mar
Mar
Aug
Aug
Mar
Mar

16,
16,
23,
23,
23,
23,
23,
30,
27,
27,
15,
15,
29,
29,

2007

2007

2007

2007

2007

2014

2014

2008

2007

2007

2008

2008

2002

2002

N020758 002 Sep 30, 1997

N020758 003 Aug 31, 1998

A091370
A091370
A201505
A201505
A203630
A203630
A203500
A203500
A201524
A201524
A202414
A202414
A077969
A077969
A203072
A203072
A090351
A090351
A077446
A077446
A077369
A077369
A091539
A091539

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Oct
Oct
Oct
Oct
Feb
Feb
Sep
Sep
Feb
Feb
Sep
Sep
Sep
Sep
May
May
Oct
Oct
Sep
Sep
Mar
Mar
Oct
Oct

15,
15,
15,
15,
22,
22,
27,
27,
27,
27,
27,
27,
27,
27,
09,
09,
15,
15,
27,
27,
30,
30,
22,
22,

2012

2012

2012

2012

2013

2013

2012

2012

2013

2013

2012

2012

2012

2012

2014

2014

2012

2012

2012

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-190(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

LISINOPRIL AND HYDROCHLOROTHIAZIDE

AB
APOTEX INC
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
AUROBINDO
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
HIKMA INTL PHARMS
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
IVAX SUB TEVA PHARMS
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
LUPIN
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
MYLAN
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
PRINSTON INC
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
SANDOZ
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
SUN PHARM INDS LTD
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

AB
WATSON LABS
12.5MG;10MG

AB
12.5MG;20MG

AB
25MG;20MG

ZESTORETIC
AB
ALVOGEN IPCO SARL
12.5MG;10MG

AB
+
12.5MG;20MG

AB
+
25MG;20MG

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET;ORAL

HYZAAR

AB
MERCK SHARP DOHME
12.5MG;50MG

AB
12.5MG;100MG

AB
+
25MG;100MG

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

AB
ALEMBIC PHARMS LTD
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
APOTEX
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
AUROBINDO PHARMA
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
CADISTA PHARMS
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
IPCA LABS LTD
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
LUPIN LTD
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
MACLEODS PHARMS LTD
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
MYLAN
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
ROXANE
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
SANDOZ
12.5MG;50MG

A076674
A076674
A076674
A077606
A077606
A077606
A076265
A076265
A076265
A075776
A075776
A075776
A077912
A077912
A077912
A076113
A076113
A076113
A076230
A076230
A076230
A076262
A076262
A076262
A076007
A076007
A076007
A076194
A076194
A076194

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
003
001
002

Oct
Oct
Oct
Mar
Mar
Mar
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

05,
05,
05,
14,
14,
14,
08,
08,
08,
01,
01,
01,
27,
27,
27,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2004

2004

2004

2006

2006

2006

2002

2002

2002

2002

2002

2002

2006

2006

2006

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

N019888 003 Nov 18, 1993

N019888 001 Sep 20, 1990

N019888 002 Jul 20, 1989

N020387 001 Apr 28, 1995

N020387 003 Oct 20, 2005

N020387 002 Nov 10, 1998

A091617
A091617
A091617
A090150
A090150
A090150
A091629
A091629
A091629
A201845
A201845
A201845
A201682
A201682
A201682
A078245
A078245
A078245
A202289
A202289
A202289
A091652
A091652
A091652
A077732
A077732
A077732
A077948

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
002
001
003
001

Feb
Feb
Feb
Oct
Aug
Oct
Oct
Oct
Jan
Sep
Sep
Sep
Mar
Mar
Mar
Oct
May
Oct
Aug
Aug
Aug
Oct
Apr
Oct
Oct
Apr
Oct
Oct

17,
17,
17,
06,
11,
06,
06,
06,
06,
18,
18,
18,
01,
01,
01,
06,
21,
06,
09,
09,
09,
06,
06,
06,
06,
06,
06,
06,

2012

2012

2012

2010

2010

2010

2010

2010

2010

2012

2012

2012

2013

2013

2013

2010

2010

2010

2012

2012

2012

2010

2010

2010

2010

2010

2010

2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-191(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET;ORAL

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

AB
12.5MG;100MG

AB
25MG;100MG

AB
TEVA PHARMS
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
TORRENT PHARMS
12.5MG;50MG

AB
12.5MG;100MG

AB
25MG;100MG

AB
ZYDUS PHARMS USA INC
12.5MG;50MG

AB

25MG;100MG

A077948
A077948
A077157
A077157
A077157
A090528
A090528
A090528
A078385
A078385

HYDROCHLOROTHIAZIDE; METHYLDOPA

TABLET;ORAL

METHYLDOPA AND HYDROCHLOROTHIAZIDE

MYLAN
15MG;250MG

+
25MG;250MG

A070265 002 Jan 23, 1986

A070265 001 Jan 23, 1986

HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE

TABLET, EXTENDED RELEASE;ORAL

DUTOPROL

CONCORDIA PHARMS INC
12.5MG;EQ 25MG TARTRATE

12.5MG;EQ 50MG TARTRATE

+
12.5MG;EQ 100MG TARTRATE

N021956 001 Aug 28, 2006

N021956 002 Aug 28, 2006

N021956 003 Aug 28, 2006

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET;ORAL

LOPRESSOR HCT

AB
US PHARMS HOLDINGS I
25MG;50MG

AB
+
25MG;100MG

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE

AB
ALEMBIC PHARMS LTD
25MG;50MG

AB
25MG;100MG

AB
50MG;100MG

AB
MYLAN
25MG;50MG

AB
25MG;100MG

AB
50MG;100MG

AB
SUN PHARM INDS
25MG;50MG

AB
25MG;100MG

AB
50MG;100MG

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AB
GLENMARK PHARMS
12.5MG;7.5MG

AB
12.5MG;15MG

AB
25MG;15MG

AB
TEVA
12.5MG;7.5MG

AB
12.5MG;15MG

AB
25MG;15MG

MOEXIPRIL HYDROCHLORIDE AND HYDROCHOLROTHIAZIDE

AB
HERITAGE PHARMS INC
12.5MG;7.5MG

AB
12.5MG;15MG

AB
25MG;15MG

UNIRETIC

AB
UCB INC
12.5MG;7.5MG

AB
12.5MG;15MG

AB
+
25MG;15MG

003
002
001
002
003
001
003
002
001
002

Aug
Oct
Apr
Apr
Apr
Oct
Apr
Oct
Oct
Oct

19,
06,
06,
06,
06,
06,
06,
06,
06,
06,

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

N018303 001 Dec 31, 1984

N018303 002 Dec 31, 1984

A202870
A202870
A202870
A076792
A076792
A076792
A090654
A090654
A090654

001
002
003
001
002
003
001
002
003

Nov
Nov
Nov
Aug
Aug
Aug
Jan
Jan
Jan

06,
06,
06,
20,
20,
20,
19,
19,
19,

2013

2013

2013

2004

2004

2004

2012

2012

2012

A090718
A090718
A090718
A076980
A076980
A076980

001
002
003
001
003
002

Mar
Mar
Mar
Mar
Mar
Mar

17,
17,
17,
07,
07,
07,

2010

2010

2010

2007

2007

2007

A202150 001 Mar 07, 2014

A202150 002 Mar 07, 2014

A202150 003 Mar 07, 2014

N020729 001 Jun 27, 1997

N020729 003 Feb 14, 2002

N020729 002 Jun 27, 1997

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

TABLET;ORAL

BENICAR HCT

DAIICHI SANKYO
12.5MG;20MG

12.5MG;40MG

+
25MG;40MG

N021532 002 Jun 05, 2003

N021532 003 Jun 05, 2003

N021532 005 Jun 05, 2003

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AB
ANI PHARMS INC
25MG;40MG

AB
25MG;80MG

AB
+ MYLAN
25MG;40MG

AB
+
25MG;80MG

A072042
A072043
A070947
A070947

001
001
002
001

Mar
Mar
Mar
Apr

14,
14,
04,
01,

1988

1988

1987

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-192(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

ACCURETIC

AB
PFIZER PHARMS
12.5MG;EQ 10MG BASE
AB
12.5MG;EQ 20MG BASE
AB
+
25MG;EQ 20MG BASE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AB
APOTEX CORP
12.5MG;EQ 10MG BASE
AB
12.5MG;EQ 20MG BASE
AB
25MG;EQ 20MG BASE
AB
AUROBINDO PHARMA
12.5MG;EQ 10MG BASE
AB
12.5MG;EQ 20MG BASE
AB
25MG;EQ 20MG BASE
AB
INVAGEN PHARMS
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
AB
MYLAN
12.5MG;EQ 10MG BASE
AB
12.5MG;EQ 20MG BASE
AB
25MG;EQ 20MG BASE
AB
SUN PHARM INDS LTD
12.5MG;EQ 10MG BASE
AB
12.5MG;EQ 20MG BASE
AB
25MG;EQ 20MG BASE
QUINARETIC

AB
GAVIS PHARMS
12.5MG;EQ 10MG BASE
AB
12.5MG;EQ 20MG BASE
AB
25MG;EQ 20MG BASE
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

TABLET;ORAL

ALDACTAZIDE

AB
GD SEARLE LLC
25MG;25MG
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

AB
MUTUAL PHARM
25MG;25MG
AB
MYLAN
25MG;25MG
ALDACTAZIDE

+ GD SEARLE LLC
50MG;50MG
HYDROCHLOROTHIAZIDE; TELMISARTAN

TABLET;ORAL

MICARDIS HCT

AB
BOEHRINGER INGELHEIM
12.5MG;40MG
AB
12.5MG;80MG
AB
+
25MG;80MG
TELMISARTAN AND HYDROCHLOROTHIAZIDE

AB
ALEMBIC PHARMS LTD
12.5MG;40MG
AB
12.5MG;80MG
AB
25MG;80MG
AB
LUPIN LTD
12.5MG;40MG
AB
12.5MG;80MG
AB
25MG;80MG
AB
MACLEODS PHARMS LTD
12.5MG;40MG
AB
12.5MG;80MG
AB
25MG;80MG
AB
MYLAN PHARMS INC
12.5MG;40MG
AB
12.5MG;80MG
AB
25MG;80MG
AB
TORRENT PHARMS LTD
12.5MG;40MG
AB
12.5MG;80MG
AB
25MG;80MG
HYDROCHLOROTHIAZIDE; TRIAMTERENE

CAPSULE;ORAL

DYAZIDE

AB
+ GLAXOSMITHKLINE LLC
25MG;37.5MG
TRIAMTERENE AND HYDROCHLOROTHIAZIDE

AB
DURAMED PHARMS BARR
25MG;37.5MG
IVAX SUB TEVA PHARMS
25MG;50MG
AB
AB
LANNETT HOLDINGS INC
25MG;37.5MG
AB
MYLAN
25MG;37.5MG
AB
SANDOZ
25MG;37.5MG
AB
+
25MG;50MG

N020125 001 Dec 28, 1999

N020125 002 Dec 28, 1999

N020125 003 Dec 28, 1999

A091524
A091524
A091524
A078450
A078450
A078450
A201356
A201356
A201356
A077093
A077093
A077093
A078211
A078211
A078211

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Mar
Mar
Mar
Aug
Aug
Aug
Apr
Apr
Apr
Mar
Mar
Mar
Mar
Mar
Mar

12,
12,
12,
24,
24,
24,
20,
20,
20,
28,
28,
28,
04,
04,
04,

2013

2013

2013

2007

2007

2007

2011

2011

2011

2005

2005

2005

2009

2009

2009

A076374 001 Mar 31, 2004

A076374 002 Mar 31, 2004

A076374 003 Mar 31, 2004

N012616 004 Dec 30, 1982

A089534 001 Jul 02, 1987

A086513 001

N012616 005 Dec 30, 1982

N021162 001 Nov 17, 2000

N021162 002 Nov 17, 2000

N021162 003 Apr 19, 2004

A203010
A203010
A203010
A091351
A091351
A091351
A204169
A204169
A204169
A091648
A091648
A091648
A201192
A201192
A201192

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Feb
Feb
Feb
Aug
Aug
Aug
Nov
Nov
Nov
Feb
Feb
Feb
Feb
Feb
Feb

25,
25,
25,
07,
07,
07,
02,
02,
02,
25,
25,
25,
25,
25,
25,

2014

2014

2014

2014

2014

2014

2015

2015

2015

2014

2014

2014

2014

2014

2014

N016042 003 Mar 03, 1994

A075052
A074259
A201407
A074701
A074821
A073191

001
001
001
001
001
001

Jun
Mar
Dec
Jun
Jun
Jul

18,
30,
09,
07,
05,
31,

1999

1995

2011

1996

1997

1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-193(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; TRIAMTERENE

TABLET;ORAL

MAXZIDE

AB
+ MYLAN PHARMS INC
50MG;75MG
MAXZIDE-25

AB
MYLAN PHARMS INC
25MG;37.5MG
TRIAMTERENE AND HYDROCHLOROTHIAZIDE

AB
ANI PHARMS INC
50MG;75MG
AB
APOTEX INC
25MG;37.5MG
AB
50MG;75MG
AB
PLIVA
25MG;37.5MG
AB
SANDOZ
25MG;37.5MG
AB
50MG;75MG
AB
WATSON LABS
25MG;37.5MG
AB
50MG;75MG
HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET;ORAL

DIOVAN HCT

AB
NOVARTIS
12.5MG;80MG
AB
12.5MG;160MG
AB
12.5MG;320MG
AB
25MG;160MG
AB
+
25MG;320MG
VALSARTAN AND HYDROCHLOROTHIAZIDE

AB
ALEMBIC LTD
12.5MG;80MG
AB
12.5MG;160MG
AB
12.5MG;320MG
AB
25MG;160MG
AB
25MG;320MG
AB
APOTEX INC
12.5MG;80MG
AB
12.5MG;160MG
AB
12.5MG;320MG
AB
25MG;160MG
AB
25MG;320MG
AB
AUROBINDO PHARMA LTD
12.5MG;80MG
AB
12.5MG;160MG
AB
12.5MG;320MG
AB
25MG;160MG
AB
25MG;320MG
AB
LUPIN LTD
12.5MG;80MG
AB
12.5MG;160MG
AB
12.5MG;320MG
AB
25MG;160MG
AB
25MG;320MG
AB
MACLEODS PHARMS LTD
12.5MG;80MG
AB
12.5MG;160MG
AB
12.5MG;320MG
AB
25MG;160MG
AB
25MG;320MG
AB
MYLAN PHARMS INC
12.5MG;80MG
AB
12.5MG;160MG
AB
12.5MG;320MG
AB
25MG;160MG
AB
25MG;320MG
AB
WATSON LABS INC
12.5MG;80MG
AB
12.5MG;160MG
AB
12.5MG;320MG
AB
25MG;160MG
AB
25MG;320MG
HYDROCODONE BITARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

ZOHYDRO ER

+ PERNIX IRELAND PAIN
10MG
15MG
20MG
30MG
40MG
50MG
TABLET, EXTENDED RELEASE;ORAL

HYSINGLA

+ PURDUE PHARMA LP
20MG

N019129 001 Oct 22, 1984

N019129 003 May 13, 1988

A073467
A071251
A071251
A074026
A073281
A072011
A073449
A071851

001
002
001
001
001
001
001
001

Jan
May
Apr
Apr
Apr
Jun
Sep
Nov

31,
05,
17,
26,
30,
17,
23,
30,

1996

1998

1988

1996

1992

1988

1993

1988

N020818
N020818
N020818
N020818
N020818

001
002
004
003
005

Mar
Mar
Apr
Jan
Apr

06,
06,
28,
17,
28,

1998

1998

2006

2002

2006

A201662
A201662
A201662
A201662
A201662
A203026
A203026
A203026
A203026
A203026
A202519
A202519
A202519
A202519
A202519
A078946
A078946
A078946
A078946
A078946
A203145
A203145
A203145
A203145
A203145
A078020
A078020
A078020
A078020
A078020
A091519
A091519
A091519
A091519
A091519

001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
003
004
001
005
002
001
002
003
004
005
001
002
004
003
005
001
002
003
004
005

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr
Apr
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Mar

21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,
19,
19,
19,
19,
19,
21,
21,
21,
21,
21,
21,
21,
21,
21,
21,

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2012

2012

2012

2012

2012

2013

2013

2013

2013

2013

N202880
N202880
N202880
N202880
N202880
N202880

001
002
003
004
005
006

Oct
Oct
Oct
Oct
Oct
Oct

25,
25,
25,
25,
25,
25,

2013

2013

2013

2013

2013

2013

N206627 001 Nov 20, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-194(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROCODONE BITARTRATE

TABLET, EXTENDED RELEASE;ORAL

HYSINGLA

30MG
40MG
60MG
80MG
100MG
120MG
HYDROCODONE BITARTRATE; IBUPROFEN

TABLET;ORAL

HYDROCODONE BITARTRATE AND IBUPROFEN

AB
ACTAVIS LABS FL INC
5MG;200MG
AB
7.5MG;200MG
AB
AMNEAL PHARMS NY
5MG;200MG
AB
7.5MG;200MG
AB
SUN PHARM INDS INC
2.5MG;200MG
AB
5MG;200MG
AB
7.5MG;200MG
AB
10MG;200MG
AB
TEVA
7.5MG;200MG
AB
VINTAGE PHARMS
5MG;200MG
AB
7.5MG;200MG
AB
10MG;200MG
REPREXAIN

AB
AMNEAL PHARMS NY
2.5MG;200MG
AB
10MG;200MG
VICOPROFEN

AB
+ ABBVIE
7.5MG;200MG
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

AA
COASTAL PHARMS
5MG/5ML;60MG/5ML
AA
PADDOCK LLC
5MG/5ML;60MG/5ML
AA
TRIS PHARMA INC
5MG/5ML;60MG/5ML
REZIRA

AA
+ CYPRESS PHARM
5MG/5ML;60MG/5ML
HYDROCORTISONE

CREAM;TOPICAL

ALA-CORT

AT
CROWN LABS
AT
ANUSOL HC

AT
SALIX PHARMS
HYDROCORTISONE

AT
ACTAVIS MID ATLANTIC
AT
AT
+ FOUGERA
AT
+
AT
PERRIGO NEW YORK
AT
RISING PHARMS INC
AT
TARO
AT
VINTAGE PHARMS
SYNACORT

AT
MEDICIS
AT
ENEMA;RECTAL

COLOCORT

AB
PADDOCK LLC
CORTENEMA

AB
+ ANI PHARMS
HYDROCORTISONE

AB
TEVA PHARMS
LOTION;TOPICAL

HYDROCORTISONE

AT
+ FOUGERA PHARMS
AT
TARO
AT
VINTAGE PHARMS
NUTRACORT

AT
DOW PHARM

N206627
N206627
N206627
N206627
N206627
N206627

002
003
004
005
006
007

Nov
Nov
Nov
Nov
Nov
Nov

20,
20,
20,
20,
20,
20,

2014

2014

2014

2014

2014

2014

A077454
A076604
A076642
A076642
A091633
A091633
A091633
A091633
A076023
A077727
A077723
A077723

001
001
002
001
001
002
003
004
001
001
001
002

Jun
Dec
Mar
Oct
May
May
May
May
Apr
Nov
Nov
Nov

23,
31,
18,
12,
28,
28,
28,
28,
11,
06,
06,
06,

2010

2003

2004

2004

2013

2013

2013

2013

2003

2006

2006

2006

A076642 003 Oct 19, 2007

A076642 004 Oct 19, 2007

N020716 001 Sep 23, 1997

A205658 001 Nov 17, 2015

A204658 001 Apr 29, 2014

A203839 001 Oct 28, 2014

N022442 001 Jun 08, 2011

2.5%
1%

A080706 007 Jan 05, 2016

A080706 006

2.5%

A088250 001 Jun 06, 1984

1%
2.5%
1%
2.5%
2.5%
2.5%
2.5%
2.5%

A087795
A089682
A080693
A089414
A085025
A040879
A088799
A040503

1%
2.5%

A087458 001

A087457 001

100MG/60ML

A075172 001 Dec 03, 1999

100MG/60ML

N016199 001

100MG/60ML

A074171 001 May 27, 1994

2.5%
2.5%
2.5%

A040351 001 Jul 25, 2000

A040247 001 Jul 23, 1999

A040417 001 Jul 30, 2003

2.5%

A087644 001 Aug 24, 1982

001
001
003

001
001

001
001
001

May 03, 1983

Mar 10, 1988

Dec 16, 1986

Aug 20, 2010

Nov 09, 1984

Mar 12, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-195(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROCORTISONE

LOTION;TOPICAL

STIE-CORT

AT
PERRIGO

2.5%

ALA-SCALP

CROWN LABS

2%

OINTMENT;TOPICAL

HYDROCORTISONE

AT
ACTAVIS MID ATLANTIC
1%

AT
+ FOUGERA
2.5%

AT
+ FOUGERA PHARMS
1%

AT
PERRIGO NEW YORK
2.5%

AT
TARO
1%

HYDROCORTISONE IN ABSORBASE

AT
CAROLINA MEDCL

1%

SOLUTION;TOPICAL

TEXACORT

+ MISSION PHARMA

2.5%

TABLET;ORAL

CORTEF

AB
PHARMACIA AND UPJOHN
5MG

AB

10MG

AB
+

20MG

HYDROCORTISONE

AB
AMEDRA PHARMS

5MG

10MG

AB

20MG

AB

5MG

AB
HIKMA INTL PHARMS

10MG

AB

20MG

AB

5MG

AB
VINTAGE

10MG

AB

20MG

AB

HYDROCORTISONE ACETATE

AEROSOL, METERED;RECTAL

CORTIFOAM

+ MEDA PHARMS

CREAM;TOPICAL

HYDROCORTISONE ACETATE

+ FERNDALE LABS

MICORT-HC

+ SEBELA IRELAND LTD

A083231 001

A087796
A081203
A080692
A085027
A086257

001 Oct 13, 1982

001 May 28, 1993

001

001

001

A088138 001 Sep 06, 1985

A081271 001 Apr 17, 1992

N008697 003

N008697 001

N008697 002

A040646
A040646
A040646
A083365
A083365
A083365
A040761
A040761
A040761

001
002
003
002
003
001

001
002
003

Mar
Mar
Mar
Feb
Feb

30,
30,
30,
23,
23,

2007

2007

2007

2015

2015

Jul 16, 2007

Jul 16, 2007

Jul 16, 2007

10%

N017351 001 Feb 10, 1982

2.5%

A040259 001 Jul 29, 1999

2%

2.5%

A040398 001 Mar 29, 2002

A040396 001 Feb 27, 2001

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CREAM;TOPICAL

CORTISPORIN

+ MONARCH PHARMS
0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

AEROSOL, METERED;TOPICAL

EPIFOAM
BX
MEDA PHARMS
1%;1%

PROCTOFOAM HC
BX
MEDA PHARMS
1%;1%

CREAM;TOPICAL

PRAMOSONE

SEBELA IRELAND LTD

0.5%;1%

1%;1%

LOTION;TOPICAL

PRAMOSONE

SEBELA IRELAND LTD

1%;1%

2.5%;1%

HYDROCORTISONE ACETATE; UREA

CREAM;TOPICAL

U-CORT

TARO

A089074 001 Nov 26, 1985

1%;10%

N050218 001 Aug 09, 1985

A086457 001

A086195 001

A083778 001

A085368 001

A085980 001

A085979 001

A089472 001 Jun 13, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-196(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROCORTISONE BUTYRATE

CREAM;TOPICAL

HYDROCORTISONE BUTYRATE

AB1
TARO PHARM INDS
LOCOID

AB1 + PRECISION DERMAT
HYDROCORTISONE BUTYRATE

AB2
GLENMARK GENERICS
LOCOID LIPOCREAM

AB2 + PRECISION DERMAT
LOTION;TOPICAL

LOCOID

+ PRECISION DERMAT
OINTMENT;TOPICAL

HYDROCORTISONE BUTYRATE

AB
TARO
LOCOID

AB
+ PRECISION DERMAT
SOLUTION;TOPICAL

HYDROCORTISONE BUTYRATE

AT
TARO PHARM INDS
LOCOID

AT
+ PRECISION DERMAT
HYDROCORTISONE PROBUTATE

CREAM;TOPICAL

PANDEL

+ FOUGERA PHARMS

0.1%

A076654 001 Aug 03, 2005

0.1%

N018514 001 Mar 31, 1982

0.1%

A202145 001 Sep 27, 2013

0.1%

N020769 001 Sep 08, 1997

0.1%

N022076 001 May 18, 2007

0.1%

A076842 001 Dec 27, 2004

0.1%

N018652 001 Oct 29, 1982

0.1%

A076364 001 Jan 14, 2004

0.1%

N019116 001 Feb 25, 1987

0.1%

N020453 001 Feb 28, 1997

HYDROCORTISONE SODIUM SUCCINATE

INJECTABLE;INJECTION

A-HYDROCORT

AP
HOSPIRA
EQ
SOLU-CORTEF

AP
+ PHARMACIA AND UPJOHN
EQ
AP
+
EQ
AP
+
EQ
AP
+
EQ
HYDROCORTISONE VALERATE

CREAM;TOPICAL

HYDROCORTISONE VALERATE

AB
PERRIGO NEW YORK
AB
+ TARO
OINTMENT;TOPICAL

HYDROCORTISONE VALERATE

+ TARO

100MG BASE/VIAL

A040666 001 Apr 06, 2006

100MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL

N009866
N009866
N009866
N009866

001

002

003

004

0.2%
0.2%

A075666 001 May 24, 2000

A075042 001 Aug 25, 1998

0.2%

A075043 001 Aug 25, 1998

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OTIC

CORTISPORIN

AT
+ MONARCH PHARMS
1%;EQ 3.5MG BASE/ML;10,000
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

AT
ALCON PHARMS LTD
1%;EQ 3.5MG BASE/ML;10,000
AT
BAUSCH AND LOMB
1%;EQ 3.5MG BASE/ML;10,000
AT
LUITPOLD
1%;EQ 3.5MG BASE/ML;10,000
SUSPENSION/DROPS;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
+ ALCON PHARMS LTD
1%;EQ 3.5MG BASE/ML;10,000
SUSPENSION/DROPS;OTIC
CORTISPORIN
AT
+ CITRON PHARMA LLC
1%;EQ 3.5MG BASE/ML;10,000
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
AT
ALCON PHARMS LTD
1%;EQ 3.5MG BASE/ML;10,000
AT
LUITPOLD
1%;EQ 3.5MG BASE/ML;10,000
OTICAIR
AT
BAUSCH AND LOMB
1%;EQ 3.5MG BASE/ML;10,000
PEDIOTIC
AT
MONARCH PHARMS
1%;EQ 3.5MG BASE/ML;10,000

UNITS/ML

N050479 001

UNITS/ML
UNITS/ML
UNITS/ML

A062423 001 Aug 25, 1983

A064053 001 Dec 29, 1995
A065216 001 Oct 31, 2005

UNITS/ML

A062874 001 May 11, 1988

UNITS/ML

N060613 001

UNITS/ML
UNITS/ML

A062488 001 Nov 06, 1985

A065219 001 May 01, 2006

UNITS/ML

A064065 001 Aug 28, 1996

UNITS/ML

A062822 001 Sep 29, 1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-197(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROFLUMETHIAZIDE

TABLET;ORAL

SALURON

AB
+ SHIRE LLC

50MG

HYDROMORPHONE HYDROCHLORIDE

INJECTABLE;INJECTION

DILAUDID

AP
+ PURDUE PHARM PRODS
1MG/ML
AP
+
2MG/ML
AP
+
4MG/ML
DILAUDID-HP

AP
+ PURDUE PHARM PRODS
10MG/ML
HYDROMORPHONE HYDROCHLORIDE

AP
AKORN
10MG/ML
AP
10MG/ML
AP
BARR
10MG/ML
AP
HOSPIRA
10MG/ML
AP
HOSPIRA INC
1MG/ML
AP
2MG/ML
AP
4MG/ML
AP
10MG/ML
SOLUTION;ORAL

DILAUDID

AA
+ PURDUE PHARM PRODS
5MG/5ML
HYDROMORPHONE HYDROCHLORIDE

AA
ROXANE
5MG/5ML
TABLET;ORAL

DILAUDID

AB
PURDUE PHARM PRODS
2MG
AB
4MG
AB
+
8MG
HYDROMORPHONE HYDROCHLORIDE

AB
ELITE LABS
8MG
AB
LANNETT
2MG
AB
4MG
AB
8MG
AB
MALLINCKRODT
8MG
AB
MALLINCKRODT INC
2MG
AB
4MG
AB
ROXANE
4MG
AB
8MG
TABLET, EXTENDED RELEASE;ORAL

EXALGO

AB
MALLINCKRODT INC
8MG
AB
12MG
AB
16MG
HYDROMORPHONE HYDROCHLORIDE

AB
ACTAVIS LABS FL INC
8MG
AB
12MG
AB
16MG
AB
PADDOCK LLC
8MG
AB
12MG
AB
16MG
EXALGO

+ MALLINCKRODT INC
32MG
HYDROXOCOBALAMIN

INJECTABLE;INJECTION

CYANOKIT

+ SERB SAS
HYDROXOCOBALAMIN

+ WATSON LABS

N011949 001

N019034 003 Apr 30, 2009

N019034 004 Apr 30, 2009

N019034 005 Apr 30, 2009

N019034 001 Jan 11, 1984

A078228
A078261
A076444
A074598
N200403
N200403
N200403
A078591

001
001
001
001
001
002
003
001

Apr
Apr
Apr
Jun
Dec
Dec
Dec
Jun

14,
14,
25,
19,
01,
01,
01,
17,

2010

2010

2003

1997

2011

2011

2011

2008

N019891 001 Dec 07, 1992

A074653 001 Jul 29, 1998

N019892 003 Nov 09, 2007

N019892 002 Nov 09, 2007

N019892 001 Dec 07, 1992

A076723
A078439
A078439
A077471
A076855
A078273
A078273
A074597
A074597

001
001
002
001
001
001
002
003
001

Oct
Dec
Dec
Dec
Dec
Sep
Sep
May
Jul

18,
09,
09,
09,
23,
19,
19,
29,
29,

2005

2009

2009

2009

2004

2007

2007

2009

1998

N021217 001 Mar 01, 2010

N021217 002 Mar 01, 2010

N021217 003 Mar 01, 2010

A202144
A202144
A202144
A204278
A204278
A204278

001
002
003
001
002
003

May
May
May
Apr
Apr
Apr

12,
12,
12,
06,
06,
06,

2014

2014

2014

2015

2015

2015

N021217 004 Aug 24, 2012

5GM/VIAL (5GM/KIT)

N022041 001 Apr 08, 2011

1MG/ML

A085998 001

HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE

SOLUTION/DROPS;OPHTHALMIC

PAREMYD

+ AKORN
1%;0.25%

N019261 001 Jan 30, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-198(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROXYCHLOROQUINE SULFATE

TABLET;ORAL

HYDROXYCHLOROQUINE SULFATE

AB
HIKMA PHARMS LLC
AB
IPCA LABS LTD
AB
MYLAN
AB
SANDOZ
AB
TEVA PHARMS
AB
ZYDUS PHARMS USA INC
PLAQUENIL

AB
+ CONCORDIA PHARMS INC

200MG
200MG
200MG
200MG
200MG
200MG

A040760
A040766
A040274
A040104
A040081
A040657

001
001
001
001
001
001

200MG

N009768 001

Aug
Jun
May
Nov
Sep
Sep

15,
14,
29,
30,
30,
21,

2007

2007

1998

1995

1994

2007

HYDROXYPROGESTERONE CAPROATE

INJECTABLE;INJECTION

HYDROXYPROGESTERONE CAPROATE

+ MCGUFF
250MG/ML
SOLUTION;INTRAMUSCULAR

MAKENA

+ LUMARA HEALTH INC
1250MG/5ML (250MG/ML)

N021945 001 Feb 03, 2011

HYDROXYPROPYL CELLULOSE

INSERT;OPHTHALMIC

LACRISERT

+ ATON

5MG

N018771 001

500MG

N016295 001

500MG
500MG

A075143 001 Oct 16, 1998

A075340 001 Feb 24, 1999

200MG
300MG
400MG

N016295 002 Feb 25, 1998

N016295 003 Feb 25, 1998

N016295 004 Feb 25, 1998

25MG/ML
50MG/ML
25MG/ML
50MG/ML

A087329
A087329
A087408
A087408

001

002

001

002

10MG/5ML
10MG/5ML
10MG/5ML
10MG/5ML

A040010
A201674
A040391
A087294

001
001
001
001

Oct
Aug
Apr
Apr

28,
21,
10,
12,

1994

2013

2002

1982

10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG

A040808
A040808
A040808
A040600
A040602
A040604
A204279
A204279
A204279
A040804
A040804
A040804
A040805
A040805
A040805
A040812
A040812
A040812
A040786
A040787
A040788
A091176

001
002
003
001
001
001
001
002
003
001
002
003
001
002
003
001
002
003
001
001
001
001

Sep
Sep
Sep
Dec
Dec
Dec
Aug
Aug
Aug
Jun
Jun
Jun
May
May
May
Mar
Mar
Mar
Mar
Mar
Mar
Jun

24,
24,
24,
28,
28,
28,
20,
20,
20,
30,
30,
30,
29,
29,
29,
12,
12,
12,
20,
20,
20,
07,

2008

2008

2008

2004

2004

2004

2014

2014

2014

2008

2008

2008

2008

2008

2008

2008

2008

2008

2007

2007

2007

2010

HYDROXYUREA

CAPSULE;ORAL

HYDREA

AB
+ BRISTOL MYERS SQUIBB
HYDROXYUREA

AB
BARR
AB
PAR PHARM
DROXIA

BRISTOL MYERS SQUIBB

HYDROXYZINE HYDROCHLORIDE

INJECTABLE;INJECTION

HYDROXYZINE HYDROCHLORIDE

AP
+ FRESENIUS KABI USA
AP
+
AP
LUITPOLD
AP
SYRUP;ORAL

HYDROXYZINE HYDROCHLORIDE

AA
+ HI TECH PHARMA
AA
SILARX PHARMS INC
AA
+ VINTAGE PHARMS
AA
+ WOCKHARDT
TABLET;ORAL

HYDROXYZINE HYDROCHLORIDE

AB
AMNEAL PHARM
AB
AB
AB
ELITE LABS INC
AB
AB
AB
HERITAGE PHARMA
AB
AB
AB
HERITAGE PHARMS INC
AB
AB
AB
HETERO LABS LTD III
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
KVK TECH
AB
AB
AB
MYLAN

A200271 001 Aug 24, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-199(of 388)

PRESCRIPTION DRUG PRODUCT LIST

HYDROXYZINE HYDROCHLORIDE

TABLET;ORAL

HYDROXYZINE HYDROCHLORIDE

AB
AB
AB
NORTHSTAR HLTHCARE
AB
AB
AB
+ PLIVA
AB
+
AB
+
AB
SUN PHARM INDS INC
AB
AB
AB
VINTAGE PHARMS
AB
AB
HYDROXYZINE PAMOATE

CAPSULE;ORAL

HYDROXYZINE PAMOATE

AB
BARR

AB

AB
HERITAGE PHARMA

AB

AB
SANDOZ

AB

AB
WATSON LABS

AB

VISTARIL

AB
PFIZER

AB
+

HYDROXYZINE PAMOATE

BARR

IBANDRONATE SODIUM

INJECTABLE;INTRAVENOUS

BONIVA

AP
+ ROCHE

IBANDRONATE SODIUM

AP
APOTEX INC

AP
AUROBINDO PHARMA LTD

AP
EMCURE PHARMS LTD

AP
MYLAN LABS LTD

AP
SAGENT PHARMS

AP
SUN PHARM INDS LTD

TABLET;ORAL

BONIVA

AB
+ HOFFMANN LA ROCHE

IBANDRONATE SODIUM

AB
APOTEX INC

AB
DR REDDYS LABS LTD

AB
MUTUAL PHARM CO INC

AB
MYLAN PHARMS INC

AB
ORCHID HLTHCARE

AB
WATSON LABS INC

IBRUTINIB

CAPSULE;ORAL

IMBRUVICA

+ PHARMACYCLICS INC

IBUPROFEN

SOLUTION;INTRAVENOUS

CALDOLOR

+ CUMBERLAND PHARMS

SUSPENSION;ORAL

IBUPROFEN

AB
+ ACTAVIS MID ATLANTIC

AB
PERRIGO R AND D

TABLET;ORAL

IBU-TAB

AB
ALRA

AB

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG

HCL

HCL

HYDROCHLORIDE

HYDROCHLORIDE

HCL

HCL

HCL

HCL

A091176
A091176
A040840
A040840
A040840
A088617
A088618
A088619
A040899
A040899
A040899
A040579
A040574
A040580

002
003
002
003
001
001
001
001
001
002
003
001
001
001

Jun
Jun
Mar
Mar
Mar
Jan
Jan
Jan
Jun
Jun
Jun
May
May
May

07,
07,
31,
31,
31,
10,
10,
10,
10,
10,
10,
27,
27,
27,

2010

2010

2008

2008

2008

1986

1986

1986

2008

2008

2008

2005

2005

2005

A088496
A088487
A201507
A201507
A087479
A086183
A040156
A040156

001
001
001
002
001

001

001
002

Jun
Jun
Jun
Jun

15,
15,
03,
03,

1984

1984

2013

2013

Jul 15, 1996

Jul 15, 1996

EQ 25MG HCL

EQ 50MG HCL

N011459 002

N011459 004

EQ 100MG HCL

A088488 001 Jun 15, 1984

EQ 3MG BASE/3ML

N021858 001 Jan 06, 2006

EQ
EQ
EQ
EQ
EQ
EQ

A204222
A205332
A203987
A202671
A202235
A090853

3MG
3MG
3MG
3MG
3MG
3MG

BASE/3ML

BASE/3ML

BASE/3ML

BASE/3ML

BASE/3ML

BASE/3ML

001
001
001
001
001
001

Oct
Aug
Sep
Sep
Sep
Feb

16,
19,
02,
02,
02,
14,

2015

2015

2014

2014

2014

2014

EQ 150MG BASE

N021455 002 Mar 24, 2005

EQ
EQ
EQ
EQ
EQ
EQ

A078948
A078997
A078996
A078995
A078998
A079003

150MG
150MG
150MG
150MG
150MG
150MG

BASE

BASE

BASE

BASE

BASE

BASE

001
001
001
001
001
001

Mar
Apr
Aug
Mar
Mar
Mar

19,
30,
15,
19,
19,
20,

2012

2012

2012

2012

2012

2012

140MG

N205552 001 Nov 13, 2013

800MG/8ML (100MG/ML)

N022348 002 Jun 11, 2009

100MG/5ML

100MG/5ML

A074978 001 Mar 25, 1998

A076925 001 Sep 23, 2004

400MG

600MG

A071058 001 Aug 11, 1988

A071059 001 Aug 11, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-200(of 388)

PRESCRIPTION DRUG PRODUCT LIST

IBUPROFEN

TABLET;ORAL

IBUPROFEN

AB
AMNEAL PHARMS NY
AB
AB
AB
AB
AB
AB
CONTRACT PHARMACAL
AB
AB
AB
DR REDDYS LA
AB
AB
+
AB
DR REDDYS LABS INC
AB
AB
AB
GRANULES INDIA LTD
AB
AB
AB
MARKSANS PHARMA
AB
AB
AB
PERRIGO R AND D
AB
AB
AB
SHASUN USA
AB
AB
AB
VINTAGE PHARMS

400MG

400MG

600MG

600MG

800MG

800MG

400MG

600MG

800MG

400MG

600MG

800MG

400MG

600MG

800MG

400MG

600MG

800MG

400MG

600MG

800MG

400MG

600MG

800MG

400MG

600MG

800MG

400MG

A071334
A078558
A071335
A078558
A071935
A078558
A071267
A071268
A072300
A075682
A075682
A075682
A076112
A076112
A076112
A091625
A091625
A091625
A090796
A090796
A090796
A077114
A077114
A077114
A078329
A078329
A078329
A071644

IBUPROFEN LYSINE

INJECTABLE;INTRAVENOUS

NEOPROFEN

+ RECORDATI RARE

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

N021903 001 Apr 13, 2006

IBUPROFEN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

OXYCODONE HYDROCHLORIDE AND IBUPROFEN

400MG;5MG

AB
ACTAVIS ELIZABETH
400MG;5MG

AB
+ BARR LABS INC
400MG;5MG

AB
WATSON LABS
IBUTILIDE FUMARATE

INJECTABLE;INJECTION

CORVERT

AP
+ PHARMACIA AND UPJOHN

IBUTILIDE FUMARATE

AP
LUITPOLD

AP
MYLAN INSTITUTIONAL

AP

001
001
001
002
001
003
001
001
001
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001

Nov
Jun
Nov
Jun
Oct
Jun
Oct
Oct
Jul
Nov
Nov
Nov
Oct
Oct
Oct
Sep
Sep
Sep
Dec
Dec
Dec
Jul
Jul
Jul
Feb
Feb
Feb
Feb

25,
18,
25,
18,
13,
18,
15,
15,
01,
14,
14,
14,
31,
31,
31,
15,
15,
15,
21,
21,
21,
18,
18,
18,
05,
05,
05,
01,

1986

2007

1986

2007

1987

2007

1986

1986

1988

2001

2001

2001

2001

2001

2001

2015

2015

2015

2010

2010

2010

2005

2005

2005

2009

2009

2009

1988

A078769 001 Jan 04, 2008

A078316 001 Nov 29, 2007

A078394 001 Nov 26, 2007

0.1MG/ML

N020491 001 Dec 28, 1995

0.1MG/ML

0.1MG/ML

0.1MG/ML

A090240 001 Jan 11, 2010

A090643 001 Jan 11, 2010

A090924 001 Jan 11, 2010

ICATIBANT ACETATE

INJECTABLE;SUBCUTANEOUS

FIRAZYR

+ SHIRE ORPHAN THERAP

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N022150 001 Aug 25, 2011

ICODEXTRIN

SOLUTION;INTRAPERITONEAL

EXTRANEAL

+ BAXTER HLTHCARE

7.5GM/100ML

N021321 001 Dec 20, 2002

ICOSAPENT ETHYL

CAPSULE;ORAL

VASCEPA

+ AMARIN PHARMS

1GM

N202057 001 Jul 26, 2012

1MG/ML

N050734 001 Feb 17, 1997

1MG/ML

1MG/ML

1MG/ML

A065275 001 Dec 14, 2006

A065288 001 May 15, 2007

A065440 001 Aug 04, 2009

IDARUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

IDAMYCIN PFS

AP
+ PHARMACIA AND UPJOHN

IDARUBICIN HYDROCHLORIDE

AP
EUROHLTH INTL SARL

AP

AP
FRESENIUS KABI USA

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-201(of 388)

PRESCRIPTION DRUG PRODUCT LIST

IDARUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

IDARUBICIN HYDROCHLORIDE

AP
MYLAN LABS LTD
1MG/ML

IDARUBICIN HYDROCHLORIDE PFS

AP
TEVA PHARMS USA

1MG/ML

IDELALISIB

TABLET;ORAL

ZYDELIG

GILEAD SCIENCES INC

+

IDOXURIDINE

SOLUTION/DROPS;OPHTHALMIC

DENDRID

AT
+ ALCON

HERPLEX

AT
+ ALLERGAN

IFOSFAMIDE

INJECTABLE;INJECTION

IFEX

AP
BAXTER HLTHCARE

AP

IFOSFAMIDE

AP
EUROHLTH INTL SARL
AP
AP
+ FRESENIUS KABI USA
AP
AP
+
AP
AP
MYLAN LABS LTD
AP
AP
+ TEVA PHARMS USA
AP
+
IFOSFAMIDE; MESNA

INJECTABLE;INTRAVENOUS

IFOSFAMIDE/MESNA KIT

+ TEVA PHARMS USA

+

ILOPERIDONE

TABLET;ORAL

FANAPT

+ VANDA PHARMS INC

ILOPROST

SOLUTION;INHALATION

VENTAVIS

+ ACTELION PHARMS LTD

+

IMATINIB MESYLATE

TABLET;ORAL

GLEEVEC
AB
NOVARTIS
AB
+
IMATINIB MESYLATE
AB
SUN PHARMA GLOBAL
AB
IMIGLUCERASE

INJECTABLE;INJECTION

CEREZYME

GENZYME

+

A200144 001 Oct 11, 2012

A065036 001 May 01, 2002

100MG

150MG

N205858 001 Jul 23, 2014

N205858 002 Jul 23, 2014

0.1%

N014169 001

0.1%

N013935 002

1GM/VIAL

3GM/VIAL

N019763 001 Dec 30, 1988

N019763 002 Dec 30, 1988

1GM/20ML(50MG/ML)

3GM/60ML(50MG/ML)

1GM/VIAL

1GM/20ML (50MG/ML)

3GM/VIAL

3GM/60ML (50MG/ML)

1GM/20ML (50MG/ML)

3GM/60ML (50MG/ML)

1GM/20ML (50MG/ML)

3GM/60ML (50MG/ML)

A076619
A076619
A076078
A090181
A076078
A090181
A201689
A201689
A076657
A076657

1GM/20ML;1GM/10ML (50MG/ML;100MG/ML)

3GM/60ML;1GM/10ML (50MG/ML;100MG/ML)

A075874 001 Feb 26, 2002

A075874 002 Feb 26, 2002

1MG

2MG

4MG

6MG

8MG

10MG

12MG

N022192
N022192
N022192
N022192
N022192
N022192
N022192

10MCG/ML (10MCG/ML)

20MCG/ML (20MCG/ML)

N021779 002 Dec 08, 2005

N021779 003 Aug 07, 2009

EQ 100MG BASE

EQ 400MG BASE

N021588 001 Apr 18, 2003

N021588 002 Apr 18, 2003

EQ 100MG BASE

EQ 400MG BASE

A078340 001 Dec 03, 2015

A078340 002 Dec 03, 2015

200 UNITS/VIAL

400 UNITS/VIAL

N020367 001 May 23, 1994

N020367 002 Sep 22, 1999

001
002
001
001
002
002
001
002
001
002

001
002
003
004
005
006
007

Jun
Jun
May
Sep
May
Sep
Nov
Nov
Apr
Apr

May
May
May
May
May
May
May

29,
29,
28,
22,
28,
22,
26,
26,
04,
04,

06,
06,
06,
06,
06,
06,
06,

2011

2011

2002

2009

2002

2009

2012

2012

2007

2007

2009

2009

2009

2009

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-202(of 388)

PRESCRIPTION DRUG PRODUCT LIST

IMIPRAMINE HYDROCHLORIDE

TABLET;ORAL

IMIPRAMINE HYDROCHLORIDE

AB
LEADING PHARMA LLC
AB
AB
AB
LUPIN LTD
AB
AB
AB
MUTUAL PHARM
AB
AB
AB
PAR PHARM
AB
AB
AB
AB
SANDOZ
AB
AB
TOFRANIL

AB
MALLINCKRODT INC
AB
AB
+
IMIPRAMINE PAMOATE

CAPSULE;ORAL

IMIPRAMINE PAMOATE

AB
LUPIN LTD
AB
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
ROXANE
AB
AB
AB
TOFRANIL-PM

AB
+ MALLINCKRODT INC
AB
AB
AB
IMIQUIMOD

CREAM;TOPICAL

ALDARA

AB
+ MEDICIS
IMIQUIMOD

AB
APOTEX INC
AB
FOUGERA PHARMS
AB
G AND W LABS INC
AB
GLENMARK GENERICS
AB
PERRIGO ISRAEL
AB
STRIDES PHARMA
TARO
AB
AB
TOLMAR
ZYCLARA

+ MEDICIS
+

10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG
10MG
25MG
50MG
10MG
25MG
50MG

A040903
A040903
A040903
A090443
A090442
A090441
A081048
A081049
A081050
A088292
A089422
A088262
A088276
A084936
A083745
A084937

001
002
003
001
001
001
001
001
001
001
001
001
001
002

001

001

10MG
25MG
50MG

A087844 001 May 22, 1984

A087845 001 May 22, 1984

A087846 001 May 22, 1984

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

75MG HCL
100MG HCL
125MG HCL
150MG HCL
75MG HCL
100MG HCL
125MG HCL
150MG HCL
75MG HCL
100MG HCL
125MG HCL
150MG HCL

A090444
A090444
A090444
A090444
A202338
A202338
A202338
A202338
A091099
A091099
A091099
A091099

001
002
003
004
001
002
003
004
001
002
003
004

EQ
EQ
EQ
EQ

75MG HCL
100MG HCL
125MG HCL
150MG HCL

N017090
N017090
N017090
N017090

001

004

003

002

Oct
Oct
Oct
Mar
Mar
Mar
Jun
Jun
Jun
Oct
Jul
Oct
Oct

Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr

24,
24,
24,
11,
11,
11,
05,
05,
05,
21,
14,
21,
21,

16,
16,
16,
16,
28,
28,
28,
28,
16,
16,
16,
16,

2012

2012

2012

2010

2010

2010

1990

1990

1990

1983

1987

1983

1983

2010

2010

2010

2010

2013

2013

2013

2013

2010

2010

2010

2010

5%

N020723 001 Feb 27, 1997

5%
5%
5%
5%
5%
5%
5%
5%

A091308
A078548
A200481
A201994
A078837
A202002
A200173
A091044

2.5%
3.75%

N022483 002 Jul 15, 2011

N022483 001 Mar 25, 2010

INAMRINONE LACTATE

INJECTABLE;INJECTION

AMRINONE LACTATE

+ EUROHLTH INTL SARL

EQ 5MG BASE/ML

A075513 001 May 09, 2000

INDACATEROL MALEATE

POWDER;INHALATION

ARCAPTA NEOHALER

+ NOVARTIS

EQ 75MCG BASE

N022383 001 Jul 01, 2011

001
001
001
001
001
001
001
001

Apr
Feb
Apr
Mar
Sep
Jun
Apr
Feb

06,
25,
18,
06,
07,
24,
15,
28,

2012

2010

2011

2012

2010

2014

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-203(of 388)

PRESCRIPTION DRUG PRODUCT LIST

INDAPAMIDE

TABLET;ORAL

INDAPAMIDE

AB
ACTAVIS ELIZABETH
AB
AB
ANI PHARMS INC
AB
AB
MYLAN
AB
+
AB
MYLAN PHARMS INC
AB

1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG

A074722
A074722
A074299
A074299
A074461
A074461
A075105
A075105

INDINAVIR SULFATE

CAPSULE;ORAL

CRIXIVAN

MERCK SHARP DOHME
+

EQ 200MG BASE
EQ 400MG BASE

N020685 003 Mar 13, 1996

N020685 001 Mar 13, 1996

2mCi/0.2ML

N019862 001 Dec 29, 1992

5mCi/0.5ML

N019841 001 Sep 27, 1994

INDIUM IN-111 CHLORIDE

INJECTABLE;INJECTION

INDICLOR

+ GE HEALTHCARE
INDIUM IN 111 CHLORIDE

+ MALLINCKRODT

001
002
002
001
002
001
001
002

Jun
Jun
Apr
Jul
Mar
Mar
Jul
Jul

17,
17,
29,
27,
26,
27,
23,
23,

1996

1996

1996

1995

1997

1996

1998

1998

INDIUM IN-111 OXYQUINOLINE

INJECTABLE;INJECTION

INDIUM IN-111 OXYQUINOLINE

+ GE HEALTHCARE
1mCi/ML

N019044 001 Dec 24, 1985

INDIUM IN-111 PENTETATE DISODIUM

INJECTABLE;INTRATHECAL

MPI INDIUM DTPA IN 111

+ GE HEALTHCARE
1mCi/ML

N017707 001 Feb 18, 1982

INDIUM IN-111 PENTETREOTIDE KIT

INJECTABLE;INJECTION

OCTREOSCAN

+ MALLINCKRODT
3mCi/ML

N020314 001 Jun 02, 1994

INDOCYANINE GREEN

INJECTABLE;INJECTION

IC-GREEN

AP
+ AKORN
INDOCYANINE GREEN

AP
PULSION MEDCL

25MG/VIAL

N011525 001

25MG/VIAL

A040811 001 Nov 21, 2007

INDOMETHACIN

CAPSULE;ORAL

INDOMETHACIN

AB
GLENMARK GENERICS
25MG
AB
50MG
AB
HERITAGE PHARMS INC
25MG
AB
50MG
AB
HETERO LABS LTD III
25MG
AB
50MG
AB
IVAX SUB TEVA PHARMS
25MG
AB
50MG
AB
MYLAN
25MG
AB
+
50MG
AB
SANDOZ
25MG
AB
50MG
AB
SUN PHARM INDS INC
25MG
AB
50MG
AB
ZYDUS PHARMS USA INC
25MG
AB
50MG
TIVORBEX

IROKO PHARMS LLC
20MG
+
40MG
CAPSULE, EXTENDED RELEASE;ORAL

INDOMETHACIN

AB
AMNEAL PHARMS
75MG
AB
AVANTHI INC
75MG
AB
HETERO LABS LTD III
75MG
AB
JUBILANT GENERICS
75MG
AB
MYLAN PHARMS INC
75MG

A091276
A091276
N018851
N018851
A091240
A091240
A070719
A070756
N018858
A070624
A070673
A070674
A091401
A091401
A090403
A090403

001
002
001
002
001
002
001
001
001
001
001
001
001
002
001
002

Dec
Dec
May
May
Apr
Apr
Feb
Feb
Apr
Sep
Apr
Apr
Mar
Mar
Nov
Nov

22,
22,
18,
18,
12,
12,
12,
12,
20,
04,
29,
29,
28,
28,
15,
15,

2010

2010

1984

1984

2011

2011

1986

1986

1984

1985

1987

1987

2013

2013

2010

2010

N204768 001 Feb 24, 2014

N204768 002 Feb 24, 2014

A091549
A079175
A201807
A202706
A202139

001
001
001
001
001

Dec
Mar
Sep
Oct
Mar

01,
06,
28,
05,
20,

2010

2009

2012

2015

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

INDOMETHACIN

CAPSULE, EXTENDED RELEASE;ORAL

INDOMETHACIN

AB
PADDOCK LLC
75MG

AB
+ SANDOZ
75MG

AB
WATSON LABS INC
75MG

INJECTABLE;INJECTION

INDOMETHACIN

+ FRESENIUS KABI USA

EQ 1MG BASE/VIAL

SUPPOSITORY;RECTAL

INDOMETHACIN

+ G AND W LABS

50MG

SUSPENSION;ORAL

INDOCIN

+ IROKO PHARMS

25MG/5ML

INDOMETHACIN SODIUM

INJECTABLE;INJECTION

INDOCIN

AP
+ RECORDATI RARE

INDOMETHACIN SODIUM

AP
EUROHLTH INTL SARL

INGENOL MEBUTATE

GEL;TOPICAL

PICATO

+ LEO PHARMA AS

+

INSULIN DETEMIR RECOMBINANT

INJECTABLE;SUBCUTANEOUS

LEVEMIR

+ NOVO NORDISK INC

LEVEMIR FLEXPEN

+ NOVO NORDISK INC

LEVEMIR FLEXTOUCH

+ NOVO NORDISK INC

INSULIN GLARGINE

SOLUTION;SUBCUTANEOUS

BASAGLAR

ELI LILLY AND CO

N022536 001 Mar 17, 2010

A073314 001 Aug 31, 1992

N018332 001 Oct 10, 1985

N018878 001 Jan 30, 1985

EQ 1MG BASE/VIAL

A078713 001 Jul 16, 2008

0.015%

0.05%

N202833 001
Jan 23, 2012

N202833 002
Jan 23, 2012

N021172 001
Nov 01, 2001

N021172 004
May 03, 2002

1000 UNITS/10ML (100 UNITS/ML)

N020986 001
Jun 07, 2000

300 UNITS/3ML (100 UNITS/ML)

N020986 003
Jan 19, 2001

300 UNITS/3ML (100 UNITS/ML)

N020986 005
Oct 31, 2013

300 UNITS/3ML (100 UNITS/ML)

N020986 002
Jun 07, 2000

INSULIN ASPART; INSULIN DEGLUDEC

SOLUTION;SUBCUTANEOUS

RYZODEG 70/30

+ NOVO NORDISK INC

90 UNITS/3ML;210 UNITS/3ML (30

UNITS/ML;70 UNITS/ML)

INSULIN DEGLUDEC

SOLUTION;SUBCUTANEOUS

TRESIBA

NOVO NORDISK INC

+

A200529 001 Nov 30, 2010

A074464 001 May 28, 1998

A202572 001 Dec 09, 2013

EQ 1MG BASE/VIAL

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE;SUBCUTANEOUS

NOVOLOG MIX 70/30

+ NOVO NORDISK INC

700 UNITS/10ML;300 UNITS/10ML (70

UNITS/ML; 30 UNITS/ML)

NOVOLOG MIX 70/30 FLEXPEN

+ NOVO NORDISK INC

210 UNITS/3ML;90 UNITS/3ML (70

UNITS/ML; 30 UNITS/ML)

INSULIN ASPART RECOMBINANT

INJECTABLE;SUBCUTANEOUS

NOVOLOG

+ NOVO NORDISK INC

NOVOLOG FLEXPEN

+ NOVO NORDISK INC

NOVOLOG FLEXTOUCH

+ NOVO NORDISK INC

NOVOLOG PENFILL

+ NOVO NORDISK INC

3-204(of 388)

N203313 001
Sep 25, 2015

300 UNITS/3ML (100 UNITS/ML)

600 UNITS/3ML (200 UNITS/ML)

N203314 001
Sep 25, 2015

N203314 002
Sep 25, 2015

1000 UNITS/10ML (100 UNITS/ML)

N021536 001
Jun 16, 2005

300 UNITS/3ML (100 UNITS/ML)

N021536 002
Jun 16, 2005

300 UNITS/3ML (100 UNITS/ML)

N021536 005
Oct 31, 2013

300 UNITS/3ML (100 UNITS/ML)

N205692 001
Dec 16, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

INSULIN GLARGINE RECOMBINANT

INJECTABLE;INJECTION

LANTUS

+ SANOFI AVENTIS US

LANTUS SOLOSTAR

+ SANOFI AVENTIS US

SOLUTION;SUBCUTANEOUS

TOUJEO SOLOSTAR

+ SANOFI US SERVICES

100 UNITS/ML

N021081 001 Apr 20, 2000

300 UNITS/3ML (100 UNITS/ML)

N021081 002 Apr 27, 2007

300 UNITS/ML (300 UNITS/ML)

N206538 001 Feb 25, 2015

INSULIN GLULISINE RECOMBINANT

INJECTABLE;IV (INFUSION), SUBCUTANEOUS

APIDRA

+ SANOFI AVENTIS US
1000 UNITS/10ML (100 UNITS/ML)

+
300 UNITS/3ML (100 UNITS/ML)

INJECTABLE;SUBCUTANEOUS

APIDRA SOLOSTAR

SANOFI AVENTIS US
300 UNITS/3ML

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

INJECTABLE;INJECTION

HUMALOG MIX 50/50

+ LILLY

50 UNITS/ML;50 UNITS/ML

HUMALOG MIX 50/50 KWIKPEN

+ LILLY

50 UNITS/ML;50 UNITS/ML

HUMALOG MIX 75/25

+ LILLY

75 UNITS/ML;25 UNITS/ML

HUMALOG MIX 75/25 KWIKPEN

+ LILLY

75 UNITS/ML;25 UNITS/ML

INSULIN LISPRO RECOMBINANT

INJECTABLE;INJECTION

HUMALOG

+ LILLY

HUMALOG KWIKPEN

+ LILLY

SOLUTION;SUBCUTANEOUS

HUMALOG KWIKPEN

+ ELI LILLY AND CO

3-205(of 388)

N021629 001 Apr 16, 2004

N021629 002 Dec 20, 2005

N021629 003 Feb 24, 2009

N021018 001 Dec 22, 1999

N021018 002 Sep 06, 2007

N021017 001 Dec 22, 1999

N021017 002 Sep 06, 2007

100 UNITS/ML

N020563 001 Jun 14, 1996

100 UNITS/ML

N020563 003 Sep 06, 2007

200 UNITS/ML

N205747 001 May 26, 2015

500 UNITS/ML

N018780 004 Mar 31, 1994

4 UNITS/INH

8 UNITS/INH

12 UNITS/INH

N022472 001 Jun 27, 2014

N022472 002 Jun 27, 2014

N022472 003 Apr 17, 2015

IOBENGUANE SULFATE I-123

SOLUTION;INTRAVENOUS

ADREVIEW

+ GE HEALTHCARE

10mCi/5ML (2mCi/ML)

N022290 001 Sep 19, 2008

IODIPAMIDE MEGLUMINE

INJECTABLE;INJECTION

CHOLOGRAFIN MEGLUMINE

+ BRACCO

52%

N009321 003

55%

55%

N020351 001 Mar 22, 1996

N020808 001 Aug 29, 1997

65.2%

65.2%

N020351 002 Mar 22, 1996

N020808 002 Aug 29, 1997

5mCi/2.5ML (2mCi/ML)

N022454 001 Jan 14, 2011

INSULIN RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN R

+ LILLY

POWDER;INHALATION

AFREZZA

SANOFI AVENTIS

+

IODIXANOL

INJECTABLE;INJECTION

VISIPAQUE 270

+ GE HEALTHCARE

VISIPAQUE 320

+ GE HEALTHCARE

IOFLUPANE I-123

SOLUTION;INTRAVENOUS

DATSCAN

+ GE HLTHCARE INC

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

IOHEXOL

FOR SOLUTION;ORAL

ORALTAG

INTERPHARMA PRAHA AS
INJECTABLE;INJECTION

OMNIPAQUE 140

+ GE HEALTHCARE
SOLUTION;INJECTION, ORAL

OMNIPAQUE 350

+ GE HEALTHCARE

3-206(of 388)

9.7GM/BOT

N205383 001 Mar 26, 2015

30.2%

N018956 005 Nov 30, 1988

75.5%
75.5%
SOLUTION;INJECTION, ORAL, RECTAL

OMNIPAQUE 180

+ GE HEALTHCARE
38.8%
OMNIPAQUE 240

+ GE HEALTHCARE
51.8%
51.8%
OMNIPAQUE 300

+ GE HEALTHCARE
64.7%
64.7%

N018956 004 Dec 26, 1985

N020608 003 Oct 24, 1995

IOPAMIDOL

INJECTABLE;INJECTION

ISOVUE-300

AP
+ BRACCO
ISOVUE-370

AP
+ BRACCO
SCANLUX-300

AP
MYLAN INSTITUTIONAL
SCANLUX-370

AP
MYLAN INSTITUTIONAL
ISOVUE-200

+ BRACCO
ISOVUE-250

+ BRACCO
+
ISOVUE-300

+ BRACCO
ISOVUE-370

+ BRACCO
ISOVUE-M 200

+ BRACCO
ISOVUE-M 300

+ BRACCO

N018956 002 Dec 26, 1985

N020608 001 Oct 24, 1995

N018956 003 Dec 26, 1985

N020608 002 Oct 24, 1995

61%

N018735 002 Dec 31, 1985

76%

N018735 003 Dec 31, 1985

61%

A090394 001 Jun 18, 2010

76%

A090394 002 Jun 18, 2010

41%

N018735 006 Jul 07, 1987

51%
51%

N018735 007 Jul 06, 1992

N020327 002 Oct 12, 1994

61%

N020327 003 Oct 12, 1994

76%

N020327 004 Oct 12, 1994

41%

N018735 001 Dec 31, 1985

61%

N018735 004 Dec 31, 1985

IOPROMIDE

INJECTABLE;INJECTION

ULTRAVIST (PHARMACY BULK)

+ BAYER HLTHCARE
49.9%
+
62.3%
+
76.9%
ULTRAVIST 150

+ BAYER HLTHCARE
31.2%
ULTRAVIST 240

+ BAYER HLTHCARE
49.9%
ULTRAVIST 300

+ BAYER HLTHCARE
62.3%
ULTRAVIST 300 IN PLASTIC CONTAINER

+ BAYER HLTHCARE
62.3%
ULTRAVIST 370

+ BAYER HLTHCARE
76.9%
IOTHALAMATE MEGLUMINE

INJECTABLE;INJECTION

CONRAY

+ LIEBEL-FLARSHEIM
CONRAY 30

+ LIEBEL-FLARSHEIM
CONRAY 43

+ LIEBEL-FLARSHEIM
SOLUTION;INTRAVESICAL

CYSTO-CONRAY II

LIEBEL-FLARSHEIM

N018956 001 Dec 26, 1985

N021425 003 Mar 12, 2004

N021425 001 Sep 20, 2002

N021425 002 Sep 20, 2002

N020220 004 May 10, 1995

N020220 003 May 10, 1995

N020220 002 May 10, 1995

N020220 005 Nov 18, 2008

N020220 001 May 10, 1995

60%

N013295 001

30%

N016983 001

43%

N013295 002

17.2%

N017057 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-207(of 388)

PRESCRIPTION DRUG PRODUCT LIST

IOTHALAMATE SODIUM I-125

INJECTABLE;INJECTION

GLOFIL-125

ISOTEX
IOVERSOL

INJECTABLE;INJECTION

OPTIRAY 240

+ LIEBEL-FLARSHEIM
OPTIRAY 300

+ LIEBEL-FLARSHEIM
+
OPTIRAY 320

+ LIEBEL-FLARSHEIM
+
OPTIRAY 350

+ LIEBEL-FLARSHEIM
+
IOXILAN

INJECTABLE;INJECTION

OXILAN-300

GUERBET
OXILAN-350

GUERBET
IPRATROPIUM BROMIDE

AEROSOL, METERED;INHALATION

ATROVENT HFA

+ BOEHRINGER INGELHEIM
SOLUTION;INHALATION

IPRATROPIUM BROMIDE

AN
BAUSCH AND LOMB
AN
LANDELA PHARM
AN
+ MYLAN SPECLT
AN
NEPHRON
AN
RITEDOSE CORP
AN
WATSON LABS
SPRAY, METERED;NASAL

ATROVENT

AB
+ BOEHRINGER INGELHEIM
AB
+
IPRATROPIUM BROMIDE

AB
BAUSCH AND LOMB
AB
AB
MYLAN SPECLT
AB
AB
ROXANE
AB
IRBESARTAN

TABLET;ORAL

AVAPRO

AB
SANOFI AVENTIS US
AB
AB
+
IRBESARTAN

AB
AJANTA PHARMA LTD
AB
AB
AB
ALEMBIC PHARMS LTD
AB
AB
AB
APOTEX INC
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
CIPLA LTD
AB
AB
AB
DR REDDYS LABS LTD
AB

250-300uCi/ML

N017279 001

51%

N019710 002 Dec 30, 1988

64%
64%

N019710 004 Jan 22, 1992

N020923 004 May 13, 1999

68%
68%

N019710 001 Dec 30, 1988

N020923 002 May 29, 1998

74%
74%

N019710 005 Jan 22, 1992

N020923 003 May 28, 1998

62%

N020316 001 Dec 21, 1995

73%

N020316 002 Dec 21, 1995

0.021MG/INH

N021527 001 Nov 27, 2004

0.02%
0.02%
0.02%
0.02%
0.02%
0.02%

A075835
A077072
A074755
A075562
A075693
A076291

0.021MG/SPRAY
0.042MG/SPRAY

N020393 001 Oct 20, 1995

N020394 001 Oct 20, 1995

0.021MG/SPRAY
0.042MG/SPRAY
0.021MG/SPRAY
0.042MG/SPRAY
0.021MG/SPRAY
0.042MG/SPRAY

A076025
A076103
A075552
A075553
A076664
A076598

75MG
150MG
300MG

N020757 001 Sep 30, 1997

N020757 002 Sep 30, 1997

N020757 003 Sep 30, 1997

75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG

A203685
A203685
A203685
A091236
A091236
A091236
A200832
A200832
A200832
A203081
A203081
A203081
A077205
A077205
A077205
A203161
A203161

001
001
001
001
001
001

001
001
001
001
001
001

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002

Oct
Jul
Jan
Sep
Jan
May

Mar
Mar
Mar
Mar
Nov
Nov

Dec
Dec
Dec
Oct
Oct
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Nov
Nov
Nov
Sep
Sep

15,
19,
10,
27,
26,
09,

31,
31,
31,
31,
05,
05,

10,
10,
10,
15,
15,
15,
15,
15,
15,
27,
27,
27,
14,
14,
14,
27,
27,

2001

2005

1997

2001

2001

2005

2003

2003

2003

2003

2003

2003

2015

2015

2015

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-208(of 388)

PRESCRIPTION DRUG PRODUCT LIST

IRBESARTAN

TABLET;ORAL

IRBESARTAN
AB
AB
HETERO LABS LTD V
AB
AB
AB
JUBILANT GENERICS
AB
AB
AB
LUPIN LTD
AB
AB
AB
MACLEODS PHARMS LTD
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
PRINSTON INC
AB
AB
AB
ROXANE
AB
AB
AB
SANDOZ
AB
AB
AB
SCIEGEN PHARMS INC
AB
AB
AB
TEVA PHARMS
AB
AB
AB
UNICHEM LABS LTD
AB
AB
AB
WATSON LABS INC
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
IRINOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

CAMPTOSAR

AP
+ PFIZER INC

AP
+

IRINOTECAN HYDROCHLORIDE

AP
ACCORD HLTHCARE

AP

AP
ACTAVIS TOTOWA

AP

AP

AP
AKORN

AP

AP
BEDFORD LABS

AP

AP
CIPLA LTD

AP

AP
DR REDDYS LABS LTD

AP

AP
EBEWE PHARMA

AP

AP
EMCURE PHARMS LTD

AP

AP
FRESENIUS KABI ONCOL

AP

AP
FRESENIUS KABI USA

AP

AP
HIKMA FARMACEUTICA

AP

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

300MG

A203161
A202910
A202910
A202910
A203534
A203534
A203534
A201531
A201531
A201531
A202254
A202254
A202254
A200461
A200461
A200461
A203071
A203071
A203071
A090201
A090201
A090201
A077466
A077466
A077466
A204774
A204774
A204774
A077159
A077159
A077159
A203020
A203020
A203020
A090720
A090720
A090720
A079213
A079213
A079213

003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

N020571 001 Jun 14, 1996

N020571 002 Jun 14, 1996

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

500MG/25ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

A079068
A079068
A078589
A078589
A078589
A090726
A090726
A078753
A078753
A077219
A077219
A078953
A078953
A090137
A090137
A200771
A200771
A078188
A078188
A077776
A077776
A091032
A091032

001
002
001
002
003
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Sep
Sep
Sep
Sep
Feb
Feb
Feb
Oct
Oct
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Sep
Sep
Sep
Dec
Dec
Dec
Mar
Mar
Mar
Dec
Dec
Dec
Oct
Oct
Oct
Sep
Sep
Sep

Nov
Nov
Feb
Feb
Nov
Sep
Sep
Dec
Dec
Feb
Feb
Apr
Apr
Nov
Nov
Feb
Feb
Feb
Feb
Feb
Feb
Dec
Dec

27,
27,
27,
27,
23,
23,
23,
15,
15,
15,
03,
03,
03,
27,
27,
27,
27,
27,
27,
15,
15,
15,
27,
27,
27,
07,
07,
07,
30,
30,
30,
07,
07,
07,
12,
12,
12,
27,
27,
27,

21,
21,
27,
27,
18,
16,
16,
24,
24,
20,
20,
15,
15,
12,
12,
14,
14,
27,
27,
27,
27,
20,
20,

2012

2012

2012

2012

2015

2015

2015

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2015

2015

2015

2012

2012

2012

2015

2015

2015

2012

2012

2012

2012

2012

2012

2008

2008

2008

2008

2015

2009

2009

2008

2008

2008

2008

2010

2010

2009

2009

2012

2012

2008

2008

2008

2008

2010

2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-209(of 388)

PRESCRIPTION DRUG PRODUCT LIST

IRINOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

IRINOTECAN HYDROCHLORIDE

AP
HISUN PHARM HANGZHOU
40MG/2ML (20MG/ML)
AP
100MG/5ML (20MG/ML)
AP
HOSPIRA
40MG/2ML (20MG/ML)
AP
100MG/5ML (20MG/ML)
AP
+
500MG/25ML (20MG/ML)
AP
JIANGSU HENGRUI MED
40MG/2ML (20MG/ML)
AP
100MG/5ML (20MG/ML)
AP
MUSTAFA NEVZAT ILAC
40MG/2ML (20MG/ML)
AP
100MG/5ML (20MG/ML)
AP
PLIVA LACHEMA
40MG/2ML (20MG/ML)
AP
100MG/5ML (20MG/ML)
AP
SUN PHARMA GLOBAL
40MG/2ML (20MG/ML)
AP
100MG/5ML (20MG/ML)
AP
TEVA PHARMS USA
40MG/2ML (20MG/ML)
AP
100MG/5ML (20MG/ML)
AP
500MG/25ML (20MG/ML)
CAMPTOSAR

+ PFIZER INC
300MG/15ML (20MG/ML)
INJECTABLE, LIPOSOMAL;IV (INFUSION)

ONIVYDE

+ MERRIMACK PHARMS
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
IRON DEXTRAN

INJECTABLE;INJECTION

DEXFERRUM

BP
LUITPOLD
INFED

BP
+ ACTAVIS LABS UT INC
PROFERDEX

BP
NEW RIVER
IRON SUCROSE

INJECTABLE;INTRAVENOUS

VENOFER

LUITPOLD
+

A090016
A090016
A077915
A077915
A078796
A090675
A090675
A090393
A090393
A078122
A078122
A078805
A078805
A090101
A090101
A090101

001
002
001
002
001
002
001
002
003
001
002
001
002
002
003
001

Jan
Jan
Feb
Feb
Feb
Dec
Dec
May
May
Oct
Oct
Apr
Apr
Feb
Feb
Nov

28,
28,
27,
27,
27,
16,
16,
13,
13,
31,
31,
21,
21,
27,
27,
26,

2009

2009

2008

2008

2008

2011

2011

2011

2011

2008

2008

2008

2008

2008

2008

2008

N020571 003 Aug 05, 2010

N207793 001 Oct 22, 2015

EQ 50MG IRON/ML

N040024 001 Feb 23, 1996

EQ 50MG IRON/ML

N017441 001

EQ 50MG IRON/ML

N017807 001

EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)

EQ 100MG BASE/5ML (EQ 20MG BASE/ML)
EQ 200MG BASE/10ML (EQ 20MG BASE/ML)

N021135 002 Mar 20, 2005

N021135 001 Nov 06, 2000

N021135 004 Feb 09, 2007

ISAVUCONAZONIUM SULFATE

CAPSULE;ORAL

CRESEMBA

+ ASTELLAS
POWDER;IV (INFUSION)

CRESEMBA

+ ASTELLAS

186MG

N207500 001 Mar 06, 2015

372MG

N207501 001 Mar 06, 2015

ISOCARBOXAZID

TABLET;ORAL

MARPLAN

+ VALIDUS PHARMS INC

10MG

N011961 001

99.9%

N017624 001

99.9%
99.9%
99.9%
99.9%

A075225
A074097
A074416
A074502

100MG/ML

A040648 001 Jul 05, 2005

50MG/5ML

A088235 001 Nov 10, 1983

100MG
300MG

A080936 001

A080937 002

ISOFLURANE

LIQUID;INHALATION

FORANE

AN
+ BAXTER HLTHCARE
ISOFLURANE

AN
HALOCARBON PRODS
AN
HOSPIRA
AN
PIRAMAL CRITICAL
AN
PIRAMAL ENT
ISONIAZID

INJECTABLE;INJECTION

ISONIAZID

+ SANDOZ
SYRUP;ORAL

ISONIAZID

+ CAROLINA MEDCL
TABLET;ORAL

ISONIAZID

AA
BARR
AA

001
001
001
001

Oct
Jan
Sep
Jun

20,
25,
30,
27,

1999

1993

1994

1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-210(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ISONIAZID

TABLET;ORAL

ISONIAZID

AA
+ SANDOZ
AA
+
AA
THEPHARMANETWORK LLC
AA
LANIAZID

AA
LANNETT

100MG
300MG
100MG
300MG

N008678
N008678
A202610
A202610

002

003

001 Oct 29, 2014

002 Oct 29, 2014

300MG

A089776 001 Jun 13, 1988

ISONIAZID; PYRAZINAMIDE; RIFAMPIN

TABLET;ORAL

RIFATER

+ SANOFI AVENTIS US
50MG;300MG;120MG

N050705 001 May 31, 1994

ISONIAZID; RIFAMPIN

CAPSULE;ORAL

RIFAMATE

+ SANOFI AVENTIS US

150MG;300MG

A061884 001

ISOPROTERENOL HYDROCHLORIDE

INJECTABLE;INJECTION

ISUPREL

+ HOSPIRA

0.2MG/ML

N010515 001

ISOSORBIDE DINITRATE

CAPSULE, EXTENDED RELEASE;ORAL

DILATRATE-SR

+ AUXILIUM PHARMS LLC
40MG
TABLET;ORAL

ISORDIL

AB
VALEANT PHARMS NORTH
5MG
ISOSORBIDE DINITRATE

AB
HIKMA INTL PHARMS
5MG
AB
10MG
AB
20MG
AB
30MG
AB
PAR PHARM
5MG
AB
10MG
AB
20MG
AB
+
30MG
AB
SANDOZ
5MG
AB
10MG
AB
20MG
ISORDIL

+ VALEANT PHARMS NORTH
40MG
TABLET, EXTENDED RELEASE;ORAL

ISOSORBIDE DINITRATE

AB
COREPHARMA
40MG
AB
+ SUN PHARM INDS INC
40MG
ISOSORBIDE MONONITRATE

TABLET;ORAL

ISOSORBIDE MONONITRATE

AB
ACTAVIS ELIZABETH
10MG
AB
20MG
AB
ANI PHARMS INC
20MG
AB
HIKMA PHARMS LLC
20MG
MONOKET

AB
KREMERS URBAN PHARMS
10MG
AB
+
20MG
TABLET, EXTENDED RELEASE;ORAL

ISOSORBIDE MONONITRATE

AB
DEXCEL LTD
60MG
AB
HIKMA PHARMS
30MG
AB
60MG
AB
KREMERS URBAN PHARMS
30MG
AB
60MG
AB
+
120MG
AB
NESHER PHARMS
30MG
AB
60MG
AB
120MG
30MG
AB
TORRENT PHARMS
AB
60MG
AB
120MG

N019790 001 Sep 02, 1988

N012093 007 Jul 29, 1988

A086067
A086066
A088088
A040591
A086923
A086925
A087537
A087946
A086221
A086223
A089367

001
001
001
001
001
001
001
001
001
001
001

Oct
Oct
Nov
Jan
Mar
Mar
Oct
Jan
Jan
Jan
Apr

29,
29,
02,
10,
12,
12,
02,
12,
07,
07,
07,

1987

1987

1987

2007

1987

1987

1987

1988

1988

1988

1988

N012093 001 Jul 29, 1988

A040723 001 Mar 17, 2008

A040009 001 Dec 30, 1998

A075037
A075037
A075147
A075361

002
001
001
001

Oct
Oct
Nov
Oct

30,
30,
27,
05,

1998

1998

1998

2000

N020215 002 Jun 30, 1993

N020215 001 Jun 30, 1993

A075522
A076813
A076813
A075155
A075155
A075155
A075395
A075395
A075395
A200270
A200495
A200495

001
002
001
002
001
003
001
002
003
001
001
002

Apr
Mar
Jan
Jan
Oct
Aug
Mar
Mar
Mar
Jun
Jun
Jun

17,
30,
07,
13,
30,
04,
16,
16,
16,
03,
03,
03,

2000

2006

2005

2000

1998

2000

2000

2000

2000

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-211(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ISOSORBIDE MONONITRATE

TABLET, EXTENDED RELEASE;ORAL

ISOSORBIDE MONONITRATE

AB
VINTAGE PHARMS

30MG

AB

60MG

AB

120MG

A090598 001 Aug 11, 2010

A090598 002 Aug 11, 2010

A090598 003 Aug 11, 2010

ISOSULFAN BLUE

INJECTABLE;INJECTION

ISOSULFAN BLUE

+ MYLAN INSTITUTIONAL

1%

A090874 001 Jul 20, 2010

10MG

20MG

40MG

A075945 001 Nov 08, 2002

A075945 002 Nov 08, 2002

A075945 003 Nov 08, 2002

10MG

20MG

30MG

40MG

A076356
A076135
A076135
A076135

001
002
003
001

Apr
Apr
May
Apr

11,
11,
11,
11,

2003

2003

2006

2003

10MG

20MG

30MG

40MG

A076485
A076485
A076485
A076485

001
002
004
003

Jan
Jan
Aug
Jan

19,
19,
25,
19,

2012

2012

2015

2012

10MG

20MG

30MG

40MG

A076041
A076041
A076503
A076041

001
002
001
003

Dec
Dec
Jun
Dec

24,
24,
20,
24,

2002

2002

2003

2002

10MG

20MG

30MG

40MG

A202099
A202099
A202099
A202099

001
002
004
003

Mar
Mar
Feb
Mar

25,
25,
23,
25,

2013

2013

2015

2013

10MG

20MG

30MG

40MG

25MG

35MG

N021951
N021951
N021951
N021951
N021951
N021951

001
002
003
004
005
006

May
May
May
May
Aug
Aug

25,
25,
25,
25,
15,
15,

2012

2012

2012

2012

2014

2014

A077169
A077169
A077317
A077317

001
002
001
002

Apr
Apr
Jan
Jan

24,
24,
05,
05,

2006

2006

2006

2006

ISOTRETINOIN

CAPSULE;ORAL

AMNESTEEM

AB
MYLAN PHARMS INC

AB

AB

CLARAVIS

AB
TEVA PHARMS USA

AB

AB

AB
+

MYORISAN

AB
DOUGLAS PHARMS

AB

AB

AB

SOTRET

AB
SUN PHARM INDS LTD

AB

AB

AB

ZENATANE

AB
DR REDDYS LABS LTD

AB

AB

AB

ABSORICA

BX
RANBAXY

BX

BX

BX
+

ISRADIPINE

CAPSULE;ORAL

ISRADIPINE

AB
ELITE LABS INC

2.5MG

AB

5MG

AB
WATSON LABS

2.5MG

AB
+

5MG

TABLET, EXTENDED RELEASE;ORAL

ISRADIPINE

MYLAN PHARMS INC

5MG

10MG

ITRACONAZOLE

CAPSULE;ORAL

ITRACONAZOLE

AB
MYLAN PHARMS INC

AB
SANDOZ

SPORANOX

AB
+ JANSSEN PHARMS

SOLUTION;ORAL

ITRACONAZOLE

AA
AMNEAL PHARMS

SPORANOX

AA
+ JANSSEN PHARMS

TABLET;ORAL

ONMEL

+ MERZ PHARMS

A201067 001 Nov 27, 2015

A201067 002 Nov 27, 2015

100MG

100MG

A200463 001 Jul 20, 2012

A076104 001 May 28, 2004

100MG

N020083 001 Sep 11, 1992

10MG/ML

A205573 001 Oct 30, 2015

10MG/ML

N020657 001 Feb 21, 1997

200MG

N022484 001 Apr 29, 2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-212(of 388)

PRESCRIPTION DRUG PRODUCT LIST

IVABRADINE HYDROCHLORIDE

TABLET;ORAL

CORLANOR

AMGEN INC
+

EQ 5MG BASE
EQ 7.5MG BASE

N206143 001 Apr 15, 2015

N206143 002 Apr 15, 2015

IVACAFTOR

GRANULE;ORAL

KALYDECO

VERTEX PHARMS INC
+
TABLET;ORAL

KALYDECO

+ VERTEX PHARMS

50MG/PACKET
75MG/PACKET

N207925 001 Mar 17, 2015

N207925 002 Mar 17, 2015

150MG

N203188 001 Jan 31, 2012

IVACAFTOR; LUMACAFTOR

TABLET;ORAL

ORKAMBI

+ VERTEX PHARMS INC

125MG;200MG

N206038 001 Jul 02, 2015

1%

N206255 001 Dec 19, 2014

0.5%

N202736 001 Feb 07, 2012

IVERMECTIN

CREAM;TOPICAL

SOOLANTRA

+ GALDERMA LABS LP
LOTION;TOPICAL

SKLICE

+ SANOFI PASTEUR INC
TABLET;ORAL

IVERMECTIN

AB
EDENBRIDGE PHARMS
STROMECTOL

AB
+ MERCK SHARP DOHME

3MG

A204154 001 Oct 24, 2014

3MG

N050742 002 Oct 08, 1998

IXABEPILONE

INJECTABLE;IV (INFUSION)

IXEMPRA KIT

+ R-PHARM US LLC
+

15MG/VIAL
45MG/VIAL

N022065 001 Oct 16, 2007

N022065 002 Oct 16, 2007

EQ 2.3MG BASE
EQ 3MG BASE
EQ 4MG BASE

N208462 001 Nov 20, 2015

N208462 002 Nov 20, 2015
N208462 003 Nov 20, 2015

EQ 500MG BASE/2ML
EQ 1GM BASE/3ML

A065111 001 Dec 17, 2002

A065111 002 Dec 17, 2002

EQ 10MG BASE/ML
EQ 50MG BASE/ML
EQ 100MG BASE/ML

N016812 001

N016812 002

N016812 003

EQ
EQ
EQ
EQ
EQ
EQ
EQ

A074524
A074524
A074549
A074549
A076092
A076092
A076092

IXAZOMIB CITRATE

CAPSULE;ORAL

NINLARO

MILLENNIUM PHARMS
+
KANAMYCIN SULFATE

INJECTABLE;INJECTION

KANAMYCIN SULFATE

FRESENIUS KABI USA
+
KETAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

KETALAR

AP
+ PAR STERILE PRODUCTS
AP
+
AP
+
KETAMINE HYDROCHLORIDE

AP
EUROHLTH INTL SARL
AP
AP
HOSPIRA
AP
AP
MYLAN INSTITUTIONAL
AP
AP
KETOCONAZOLE

AEROSOL, FOAM;TOPICAL

EXTINA

AT
+ DELCOR ASSET CORP
KETOCONAZOLE

AT
PERRIGO ISRAEL
CREAM;TOPICAL

KETOCONAZOLE

AB
FOUGERA PHARMS

50MG BASE/ML
100MG BASE/ML
50MG BASE/ML
100MG BASE/ML
10MG BASE/ML
50MG BASE/ML
100MG BASE/ML

001
002
001
002
001
002
003

Mar
Mar
Jun
Jun
Sep
Dec
Oct

22,
22,
27,
27,
30,
28,
25,

1996

1996

1996

1996

2008

2001

2002

2%

N021738 001 Jun 12, 2007

2%

A091550 001 Aug 25, 2011

2%

A076294 001 Apr 28, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-213(of 388)

PRESCRIPTION DRUG PRODUCT LIST

KETOCONAZOLE

CREAM;TOPICAL

KETOCONAZOLE

AB
+ TEVA
KETOZOLE

AB
TARO
GEL;TOPICAL

XOLEGEL

+ AQUA PHARMS
SHAMPOO;TOPICAL

KETOCONAZOLE

AB
PERRIGO NEW YORK
AB
TOLMAR
NIZORAL

AB
+ JANSSEN PHARMS
TABLET;ORAL

KETOCONAZOLE

AB
MYLAN
AB
TARO
AB
+ TEVA

2%

A075581 001 Apr 25, 2000

2%

A075638 001 Dec 18, 2002

2%

N021946 001 Jul 28, 2006

2%
2%

A076419 001 Jan 07, 2004

A076942 001 Apr 11, 2005

2%

N019927 001 Aug 31, 1990

200MG
200MG
200MG

A075597 001 Dec 23, 1999

A075319 001 Jun 15, 1999

A075273 001 Jun 15, 1999

KETOPROFEN

CAPSULE;ORAL

KETOPROFEN

AB
DORADO PHARMA
50MG
AB
75MG
AB
MYLAN
50MG
AB
75MG
AB
TEVA
50MG
AB
+
75MG
DORADO PHARMA
25MG
CAPSULE, EXTENDED RELEASE;ORAL

KETOPROFEN

AB
ACTAVIS LABS FL INC
100MG
AB
150MG
AB
200MG
AB
MYLAN
100MG
AB
150MG
AB
+
200MG
KETOROLAC TROMETHAMINE

INJECTABLE;INJECTION

KETOROLAC TROMETHAMINE

AP
AMPHASTAR PHARM
AP
AP
BD RX
AP
AP
FRESENIUS KABI USA
AP
AP
+ HOSPIRA
AP
AP
+
AP
AP
MYLAN LABS LTD
AP
AP
AP
AP
SAGENT PHARMS
AP
AP
SANDOZ
AP
WOCKHARDT
AP
SOLUTION/DROPS;OPHTHALMIC

ACULAR

AT
+ ALLERGAN
ACULAR LS

AT
+ ALLERGAN
ACUVAIL

AT
+ ALLERGAN
KETOROLAC TROMETHAMINE

AT
AKORN
AT
AT
ALCON PHARMS LTD

A074014
A074014
A074035
A074035
A073516
A073517
A074014

002
003
002
003
001
001
001

Jan
Jan
Dec
Dec
Dec
Dec
Jan

29,
29,
31,
31,
22,
22,
29,

1993

1993

1996

1996

1992

1992

1993

A075270
A075270
A075270
A075679
A075679
A075679

002
003
001
003
002
001

Mar
Mar
Mar
Feb
Feb
Feb

24,
24,
24,
20,
20,
20,

1999

1999

1999

2002

2002

2002

15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
15MG/ML
30MG/ML
30MG/ML
15MG/ML
15MG/ML
30MG/ML
30MG/ML
15MG/ML
30MG/ML
30MG/ML
15MG/ML
30MG/ML

A076209
A076209
A203242
A203242
A075784
A075784
A074802
A074993
A074802
A074993
A078299
A201155
A078299
A201155
A091065
A091065
A076271
A077942
A077942

001
002
001
002
001
002
001
001
002
002
001
001
002
002
001
002
002
001
002

Jul
Jul
Oct
Oct
Jan
Jan
Jun
Jan
Jun
Jan
Jul
Aug
Jul
Aug
Nov
Nov
Oct
Mar
Mar

21,
21,
07,
07,
11,
11,
05,
27,
05,
27,
16,
04,
16,
04,
27,
27,
06,
27,
27,

2004

2004

2015

2015

2002

2002

1997

1999

1997

1999

2007

2014

2007

2014

2013

2013

2004

2007

2007

0.5%

N019700 001 Nov 09, 1992

0.4%

N021528 001 May 30, 2003

0.45%

N022427 001 Jul 22, 2009

0.4%
0.5%
0.4%

A078399 001 Nov 05, 2009

A078434 001 Nov 05, 2009

A078721 001 Nov 05, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-214(of 388)

PRESCRIPTION DRUG PRODUCT LIST

KETOROLAC TROMETHAMINE

SOLUTION/DROPS;OPHTHALMIC

KETOROLAC TROMETHAMINE

AT

AT
APOTEX INC

AT

AT
SUN PHARMA GLOBAL

SPRAY, METERED;NASAL

SPRIX

+ EGALET US INC

TABLET;ORAL

KETOROLAC TROMETHAMINE

AB
+ MYLAN
AB
PLIVA
AB
TEVA

0.5%

0.4%

0.5%

0.5%

A076583
A077308
A076109
A090017

15.75MG/SPRAY

N022382 001 May 14, 2010

10MG

10MG

10MG

A074761 001 May 16, 1997

A075284 001 Jun 23, 1999

A074754 001 May 16, 1997

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

SOLUTION;IRRIGATION

OMIDRIA

+ OMEROS

EQ 4.24MG BASE/ML;EQ 12.4MG BASE/ML

N205388 001 May 30, 2014

LABETALOL HYDROCHLORIDE

INJECTABLE;INJECTION

LABETALOL HYDROCHLORIDE

AP
AKORN INC
AP
AP
EUROHLTH INTL SARL
AP
GLAND PHARMA LTD
AP
+ HOSPIRA
AP
+
LABETALOL HYDROCLORIDE

AP
SAGENT STRIDES

TABLET;ORAL

LABETALOL HYDROCHLORIDE

AB
IVAX SUB TEVA PHARMS

AB

AB

AB
MUTUAL PHARM

AB

AB

AB
PAR FORM

AB

AB

AB
SANDOZ

AB
+

AB

AB
WATSON LABS

AB

AB

TRANDATE

AB
CNTY LINE PHARMS

AB

AB

LACOSAMIDE

SOLUTION;INTRAVENOUS

VIMPAT

+ UCB INC

SOLUTION;ORAL

VIMPAT

+ UCB INC

TABLET;ORAL

VIMPAT

UCB INC

001
001
001
001

001
001
001
001
001
001

Nov
Nov
Nov
Nov

05,
05,
05,
05,

2009

2009

2009

2009

5MG/ML

5MG/ML

5MG/ML

5MG/ML

5MG/ML

5MG/ML

A075431
A075524
A075303
A090699
A075239
A075240

5MG/ML

A079134 001 Feb 03, 2010

100MG

200MG

300MG

100MG

200MG

300MG

100MG

200MG

300MG

100MG

200MG

300MG

100MG

200MG

300MG

A074787
A074787
A074787
A075215
A075215
A075215
A200908
A200908
A200908
A075113
A075113
A075113
A075133
A075133
A075133

100MG

200MG

300MG

N018716 001 May 24, 1985

N018716 002 Aug 01, 1984

N018716 003 Aug 01, 1984

200MG/20ML (10MG/ML)

N022254 001 Oct 28, 2008

10MG/ML

N022255 001 Apr 20, 2010

50MG

100MG

150MG

200MG

N022253
N022253
N022253
N022253

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

001
002
003
004

Nov
Nov
May
Apr
Nov
Nov

Aug
Aug
Aug
Jul
Jul
Jul
Jul
Jul
Jul
Aug
Aug
Aug
Aug
Aug
Aug

Oct
Oct
Oct
Oct

29,
29,
28,
03,
29,
29,

03,
03,
03,
29,
29,
29,
10,
10,
10,
04,
04,
04,
03,
03,
03,

28,
28,
28,
28,

1999

1999

1999

2012

1999

1999

1998

1998

1998

1999

1999

1999

2012

2012

2012

1998

1998

1998

1998

1998

1998

2008

2008

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-215(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LACTULOSE

FOR SOLUTION;ORAL

LACTULOSE

+ CUMBERLAND PHARMS
+
SOLUTION;ORAL

CONSTILAC

AA
ALRA
CONSTULOSE

AA
+ ACTAVIS MID ATLANTIC
LACTULOSE

AA
ANI PHARMS
AA
FRESENIUS KABI
AA
HI TECH PHARMA
AA
MORTON GROVE
AA
PHARM ASSOC
AA
ROXANE
AA
VINTAGE PHARMS
AA
VISTAPHARM
SOLUTION;ORAL, RECTAL

CHOLAC

AA
ALRA
ENULOSE

AA
+ ACTAVIS MID ATLANTIC
GENERLAC

AA
MORTON GROVE PHARMS
LACTULOSE

AA
ANI PHARMS
AA
BIO-PHARM INC
AA
FRESENIUS KABI
AA
HI TECH PHARMA
LAMIVUDINE

SOLUTION;ORAL

EPIVIR

AA
+ VIIV HLTHCARE
LAMIVUDINE

AA
SILARX PHARMS INC
EPIVIR-HBV

+ GLAXOSMITHKLINE
TABLET;ORAL

EPIVIR

AB
VIIV HLTHCARE
AB
+
EPIVIR-HBV

AB
+ GLAXOSMITHKLINE
LAMIVUDINE

AB
APOTEX
AB
AB
APOTEX INC
AB
AUROBINDO PHARMA LTD
AB
AB
HETERO LABS LTD V
AB
AB
AB
LUPIN LTD
AB
AB
MYLAN PHARMS INC
LAMIVUDINE; ZIDOVUDINE

TABLET;ORAL

COMBIVIR

+ VIIV HLTHCARE
AB
LAMIVUDINE AND ZIDOVUDINE

AB
AUROBINDO PHARMA LTD
AB
HETERO LABS LTD III
AB
HETERO LABS LTD V
AB
LUPIN LTD
AB
MYLAN PHARMS INC
AB
STRIDES PHARMA
AB
TEVA PHARMS

10GM/PACKET
20GM/PACKET

A074712 001 Dec 10, 1997

A074712 002 Dec 10, 1997

10GM/15ML

A071054 001 Jul 26, 1988

10GM/15ML

A070288 001 Aug 15, 1988

10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML

A078430
A090503
A074076
A074602
A074623
A073591
A075993
A074138

10GM/15ML

A071331 001 Jul 26, 1988

10GM/15ML

A071548 001 Aug 15, 1988

10GM/15ML

A074603 001 Oct 31, 1996

10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML

A090426
A203762
A090502
A074077

10MG/ML

N020596 001 Nov 17, 1995

10MG/ML

A203564 001 Oct 31, 2014

5MG/ML

N021004 001 Dec 08, 1998

150MG
300MG

N020564 001 Nov 17, 1995

N020564 003 Jun 24, 2002

100MG

N021003 001 Dec 08, 1998

150MG
300MG
100MG
150MG
300MG
100MG
150MG
300MG
150MG
300MG
100MG

A091606
A091606
A202941
A202032
A202032
A203260
A203277
A203277
A205217
A205217
A204002

150MG;300MG

N020857 001 Sep 26, 1997

150MG;300MG
150MG;300MG
150MG;300MG
150MG;300MG
150MG;300MG
150MG;300MG
150MG;300MG

A202418
A079124
A203259
A090246
A204005
A079128
A079081

001
001
001
001
001
001
001
001

001
001
001
001

001
002
001
001
002
001
001
002
001
002
001

001
001
001
001
001
001
001

Nov
Jan
Jul
Nov
Jul
May
Jul
Sep

Nov
Mar
Jan
Jul

Dec
Dec
Jan
Nov
Nov
Jan
Jan
Jan
Dec
Dec
Dec

May
Sep
Feb
May
Aug
May
May

28,
25,
03,
14,
30,
29,
26,
30,

21,
27,
25,
03,

02,
02,
02,
17,
17,
02,
06,
06,
18,
18,
31,

15,
17,
03,
15,
28,
13,
25,

2007

2012

1995

1996

1996

1992

2001

1992

2008

2015

2012

1995

2011

2011

2014

2011

2011

2014

2014

2014

2014

2014

2014

2012

2015

2014

2012

2014

2015

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-216(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LAMOTRIGINE

TABLET;ORAL

LAMICTAL

AB
+ GLAXOSMITHKLINE LLC
AB
AB
AB
LAMOTRIGINE

AB
ALEMBIC PHARMS LTD
AB
AB
AB
AB
ALKEM LABS LTD
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
CADISTA PHARMS
AB
AB
AB
AB
CIPLA LTD
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
AB
LUPIN LTD
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
TARO PHARM INDS
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
AB
UNICHEM LABS LTD
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB

25MG
100MG
150MG
200MG

N020241
N020241
N020241
N020241

005
001
002
003

Dec
Dec
Dec
Dec

27,
27,
27,
27,

1994

1994

1994

1994

25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
50MG
250MG

A090607
A090607
A090607
A090607
A200694
A200694
A200694
A200694
A078625
A078625
A078625
A078625
A078956
A078956
A078956
A078956
A079132
A079132
A079132
A079132
A077783
A077783
A077783
A077783
A076708
A076708
A076708
A076708
A090169
A090169
A090169
A090169
A078691
A078691
A078691
A078691
A077420
A077420
A077420
A077420
A078525
A078525
A078525
A078525
A076388
A076388
A076388
A076388
A078947
A078947
A078947
A078947
A090170
A090170
A090170
A090170
A077633
A077633
A077633
A077633
A077633
A077633

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
003
004
005
002
006

Jan
Jan
Jan
Jan
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Nov
Nov
Nov
Nov
Jan
Jan
Jan
Jan
May
May
May
May
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
Jan
Jan

13,
13,
13,
13,
14,
14,
14,
14,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
01,
01,
01,
01,
27,
27,
27,
27,
12,
12,
12,
12,
01,
01,
01,
01,
27,
27,
27,
27,
27,
27,
27,
27,
30,
30,
30,
30,
27,
27,
27,
27,
06,
06,
06,
06,
27,
27,
27,
27,
27,
27,

2011

2011

2011

2011

2013

2013

2013

2013

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2010

2010

2010

2010

2009

2009

2009

2009

2012

2012

2012

2012

2010

2010

2010

2010

2009

2009

2009

2009

2009

2009

2009

2009

2006

2006

2006

2006

2009

2009

2009

2009

2011

2011

2011

2011

2009

2009

2009

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-217(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LAMOTRIGINE

TABLET, CHEWABLE;ORAL

LAMICTAL CD

AB
GLAXOSMITHKLINE LLC

2MG

AB

5MG

AB
+

25MG

LAMOTRIGINE

AB
ALEMBIC PHARMS LTD

5MG

AB

25MG

AB
AUROBINDO PHARMA

5MG

AB

25MG

AB
DR REDDYS LABS LTD

5MG

AB

25MG

AB
GLENMARK GENERICS

5MG

AB

25MG

AB
JUBILANT GENERICS

5MG

AB

25MG

AB
MYLAN

5MG

AB

25MG

AB
TARO

5MG

AB

25MG

AB
TEVA

5MG

AB

25MG

AB
WATSON LABS

2MG

AB

5MG

AB

25MG

AB
ZYDUS PHARMS USA INC
5MG

AB

25MG

TABLET, EXTENDED RELEASE;ORAL

LAMICTAL XR

AB
GLAXOSMITHKLINE LLC

25MG

AB
+

50MG

AB

100MG

AB

200MG

AB

250MG

AB

300MG

LAMOTRIGINE

AB
ACTAVIS ELIZABETH

100MG

AB

200MG

AB

25MG

AB

50MG

AB

250MG

AB

300MG

AB
ANCHEN PHARMS

25MG

AB

50MG

AB

100MG

AB

200MG

AB

250MG

AB

300MG

AB
DR REDDYS LABS LTD

25MG

AB

50MG

AB

100MG

AB

200MG

AB

300MG

AB
PAR PHARM

25MG

AB

50MG

AB

100MG

AB

200MG

AB

250MG

AB

300MG

AB
TORRENT PHARMS LTD

25MG

AB

50MG

AB

100MG

AB

200MG

AB
WILSHIRE PHARMS INC

25MG

AB

50MG

AB

100MG

AB

200MG

AB
WOCKHARDT LTD

25MG

AB

50MG

AB

100MG

AB

200MG

N020764 004 Sep 08, 2000

N020764 001 Aug 24, 1998

N020764 002 Aug 24, 1998

A201168
A201168
A090401
A090401
A076701
A076701
A079099
A079099
A200220
A200220
A076630
A076630
A079204
A079204
A076420
A076420
A076928
A076928
A076928
A078009
A078009

001
002
002
003
001
002
001
002
001
002
001
002
001
002
001
002
001
002
003
002
003

Jun
Jun
Nov
Nov
Jan
Jan
Feb
Feb
Feb
Feb
Jan
Jan
Feb
Feb
Jun
Jun
Jan
Jan
Jan
Jan
Jan

12,
12,
04,
04,
22,
22,
19,
19,
28,
28,
22,
22,
04,
04,
21,
21,
22,
22,
22,
22,
22,

2014

2014

2009

2009

2009

2009

2009

2009

2011

2011

2009

2009

2009

2009

2006

2006

2009

2009

2009

2009

2009

N022115
N022115
N022115
N022115
N022115
N022115

001
002
003
004
006
005

May
May
May
May
Jun
Apr

29,
29,
29,
29,
21,
14,

2009

2009

2009

2009

2011

2010

A200672
A200672
A200672
A200672
A203733
A200672
A201374
A201374
A201374
A201374
A201374
A201374
A202383
A202383
A202383
A202383
A202383
A201791
A201791
A201791
A201791
A201791
A201791
A203370
A203370
A203370
A203370
A202887
A202887
A202887
A202887
A202498
A202498
A202498
A202498

003
004
001
002
001
005
001
002
003
004
005
006
001
002
003
004
005
001
002
003
004
005
006
001
002
003
004
001
002
003
004
001
002
003
004

Oct
Oct
Oct
Oct
Nov
Oct
Dec
Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Jan
Jan
Jan
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Jan

17,
17,
17,
17,
13,
17,
26,
26,
26,
26,
26,
26,
19,
19,
19,
19,
19,
18,
18,
18,
18,
18,
18,
23,
23,
23,
23,
17,
17,
17,
17,
04,
04,
04,
04,

2013

2013

2013

2013

2013

2013

2012

2012

2012

2012

2012

2012

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-218(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LAMOTRIGINE

TABLET, EXTENDED RELEASE;ORAL

LAMOTRIGINE

AB
300MG
TABLET, ORALLY DISINTEGRATING;ORAL

LAMICTAL ODT

AB
GLAXOSMITHKLINE LLC
25MG
AB
+
50MG
AB
100MG
AB
200MG
LAMOTRIGINE

AB
IMPAX LABS INC
25MG
AB
50MG
AB
100MG
AB
200MG
AB
PAR PHARM
25MG
AB
50MG
AB
100MG
AB
200MG

N022251
N022251
N022251
N022251

001
002
003
004

May
May
May
May

08,
08,
08,
08,

2009

2009

2009

2009

A200828
A200828
A200828
A200828
A204158
A204158
A204158
A204158

001
002
003
004
001
002
003
004

Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct

15,
15,
15,
15,
27,
27,
27,
27,

2013

2013

2013

2013

2015

2015

2015

2015

LANREOTIDE ACETATE

SOLUTION;SUBCUTANEOUS

SOMATULINE DEPOT

+ IPSEN PHARMA
+
+

N022074 001 Aug 30, 2007

N022074 002 Aug 30, 2007

N022074 003 Aug 30, 2007

EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
EQ 120MG BASE/0.5ML (EQ 120MG
BASE/0.5ML)

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

LANSOPRAZOLE

AB
DR REDDYS LABS LTD
15MG
AB
30MG
AB
MYLAN PHARMS INC
15MG
AB
30MG
AB
NATCO PHARMA LTD
15MG
AB
30MG
AB
SANDOZ
15MG
AB
30MG
AB
SUN PHARMA GLOBAL
15MG
AB
30MG
AB
TEVA PHARMS
15MG
AB
30MG
AB
WOCKHARDT USA
15MG
AB
30MG
AB
ZYDUS HLTHCARE
15MG
AB
30MG
LANSOPRAZOLE

AB
KRKA TOVARNA ZDRAVIL
15MG
AB
30MG
PREVACID

AB
TAKEDA PHARMS USA
15MG
AB
+
30MG
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL

PREVACID

TAKEDA PHARMS USA
15MG
+
30MG
LANTHANUM CARBONATE

POWDER;ORAL

FOSRENOL

SHIRE DEV LLC
+
TABLET, CHEWABLE;ORAL

FOSRENOL

SHIRE LLC
+

A202498 005 Jan 04, 2013

A091269
A091269
A090763
A090763
A201921
A201921
A090331
A090331
A202637
A091509
A077255
A077255
A202176
A202176
A202366
A202366

001
002
001
002
001
002
001
002
001
001
001
002
001
002
001
002

Oct
Oct
Nov
Nov
Dec
Dec
Apr
Apr
Sep
Sep
Nov
Nov
Sep
Sep
Aug
Aug

15,
15,
10,
10,
18,
18,
23,
23,
13,
13,
10,
10,
14,
14,
19,
19,

2010

2010

2009

2009

2012

2012

2010

2010

2013

2013

2009

2009

2012

2012

2013

2013

A091212 001 Sep 16, 2013

A091212 002 Sep 16, 2013

N020406 001 May 10, 1995

N020406 002 May 10, 1995

N021428 001 Aug 30, 2002

N021428 002 Aug 30, 2002

EQ 750MG BASE
EQ 1GM BASE

N204734 001 Sep 24, 2014

N204734 002 Sep 24, 2014

EQ 500MG BASE
EQ 750MG BASE
EQ 1GM BASE

N021468 002 Oct 26, 2004

N021468 003 Nov 23, 2005

N021468 004 Nov 23, 2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-219(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LAPATINIB DITOSYLATE

TABLET;ORAL

TYKERB

+ NOVARTIS PHARMS CORP

EQ 250MG BASE

N022059 001 Mar 13, 2007

0.005%

0.005%

0.005%

0.005%

0.005%

0.005%

A090887
A091449
A201006
A202077
A200925
A201786

0.005%

N020597 001 Jun 05, 1996

90MG;400MG

N205834 001 Oct 10, 2014

10MG

20MG

N020905 001 Sep 10, 1998

N020905 002 Sep 10, 1998

10MG

20MG

10MG

20MG

10MG

20MG

10MG

20MG

10MG

20MG

A091369
A091369
A077090
A077090
A077083
A077083
A077086
A077086
A077084
A077084

100MG

N020905 003 Sep 10, 1998

2.5MG

5MG

10MG

15MG

20MG

25MG

N021880
N021880
N021880
N021880
N021880
N021880

LENVATINIB MESYLATE

CAPSULE;ORAL

LENVIMA

EISAI INC

+

EQ 4MG BASE

EQ 10MG BASE

N206947 001 Feb 13, 2015

N206947 002 Feb 13, 2015

LESINURAD

TABLET;ORAL

ZURAMPIC

+ ARDEA BIOSCIENCES

200MG

N207988 001 Dec 22, 2015

2.5MG

N020726 001 Jul 25, 1997

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

2.5MG

A090934
A091303
A091191
A090491
A201804
A202716
A091098
A202048
A078190

LATANOPROST

SOLUTION/DROPS;OPHTHALMIC

LATANOPROST
AT
AKORN
AT
ALCON RES
AT
BAUSCH AND LOMB
AT
DR REDDYS LABS LTD
AT
LUITPOLD
AT
MYLAN
XALATAN
AT
+ PHARMACIA AND UPJOHN
LEDIPASVIR; SOFOSBUVIR

TABLET;ORAL

HARVONI

+ GILEAD SCIENCES INC

LEFLUNOMIDE

TABLET;ORAL

ARAVA

AB
SANOFI AVENTIS US

AB
+

LEFLUNOMIDE

AB
ALEMBIC PHARMS LTD

AB

AB
APOTEX INC

AB

AB
BARR

AB

AB
HERITAGE PHARMS INC

AB

AB
TEVA PHARMS

AB

ARAVA

+ SANOFI AVENTIS US

LENALIDOMIDE

CAPSULE;ORAL

REVLIMID

CELGENE

LETROZOLE

TABLET;ORAL

FEMARA

AB
+ NOVARTIS PHARMS

LETROZOLE

AB
ACCORD HLTHCARE

AB
APOTEX INC

AB
DR REDDYS LABS LTD

AB
FRESENIUS KABI ONCOL

AB
INDICUS PHARMA

AB
JIANGSU HENGRUI MED

AB
KUDCO IRELAND

AB
LANNETT HOLDINGS INC

AB
MYLAN

001
001
001
001
001
001

001
002
001
002
001
002
001
002
001
002

005
001
002
003
006
004

001
001
001
001
001
001
001
001
001

Jul
Mar
Mar
Feb
Mar
Mar

Nov
Nov
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

Dec
Dec
Dec
Jun
Jun
Jun

Jun
Apr
Jun
Jun
Jun
May
Jun
Oct
Dec

19,
22,
22,
11,
22,
22,

21,
21,
13,
13,
13,
13,
13,
13,
13,
13,

21,
27,
27,
29,
05,
29,

03,
19,
03,
03,
03,
16,
03,
29,
24,

2011

2011

2011

2013

2011

2011

2011

2011

2005

2005

2005

2005

2005

2005

2005

2005

2011

2005

2005

2006

2013

2006

2011

2012

2011

2011

2011

2013

2011

2014

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-220(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LETROZOLE

TABLET;ORAL

LETROZOLE

AB
NATCO PHARMA LTD
AB
ROXANE
AB
SUN PHARM INDS LTD
AB
TEVA PHARMS
AB
VINTAGE PHARMS LLC

2.5MG
2.5MG
2.5MG
2.5MG
2.5MG

LEUCOVORIN CALCIUM

INJECTABLE;INJECTION

LEUCOVORIN CALCIUM

AP
+ EUROHLTH INTL SARL
EQ 50MG BASE/VIAL
AP
+
EQ 100MG BASE/VIAL
AP
TEVA PHARMS USA
EQ 100MG BASE/VIAL
AP
EQ 350MG BASE/VIAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE

AP
+ EUROHLTH INTL SARL
EQ 200MG BASE/VIAL
AP
+
EQ 350MG BASE/VIAL
AP
FRESENIUS KABI USA
EQ 200MG BASE/VIAL
AP
SAGENT PHARMS
EQ 50MG BASE/VIAL
AP
EQ 100MG BASE/VIAL
AP
EQ 200MG BASE/VIAL
AP
EQ 350MG BASE/VIAL
+ EUROHLTH INTL SARL
EQ 10MG BASE/ML
+ FRESENIUS KABI USA
EQ 500MG BASE/VIAL
TABLET;ORAL

LEUCOVORIN CALCIUM

AB
BARR
EQ 5MG BASE
AB
EQ 25MG BASE
AB
ROXANE
EQ 5MG BASE
AB
EQ 15MG BASE
AB
+
EQ 25MG BASE
EQ 10MG BASE
LEUPROLIDE ACETATE

INJECTABLE;INJECTION

LEUPROLIDE ACETATE

AP
+ SANDOZ
AP
SUN PHARMA GLOBAL
AP
TEVA PHARMS USA
LUPRON DEPOT

+ ABBVIE ENDOCRINE INC
+
+
+
+
LUPRON DEPOT-PED

+ ABBVIE ENDOCRINE INC
+
+
+
+
INJECTABLE;SUBCUTANEOUS

ELIGARD

+ TOLMAR THERAP
+
+
+

A200161
A090838
A091466
A090289
A090789

001
001
001
001
001

Jun
Jun
Jun
Jun
Jun

03,
03,
03,
03,
03,

2011

2011

2011

2011

2011

A089384
A089717
A081277
A040174

001
001
001
001

Sep
Mar
Sep
Jun

14,
28,
28,
12,

1987

1988

1993

1997

A040056
A040335
A040258
A200753
A200753
A200753
A200855
A040347
A040286

001
001
001
001
002
003
001
001
001

May
Apr
Feb
Sep
Sep
Sep
Sep
Apr
Feb

23,
20,
26,
06,
06,
06,
06,
25,
26,

1995

2000

1999

2012

2012

2012

2012

2000

1999

A071198
A071199
A072733
A072735
A072736
A072734

001
001
001
001
001
001

Sep
Sep
Feb
Feb
Feb
Feb

24,
24,
22,
22,
22,
22,

1987

1987

1993

1993

1993

1993

1MG/0.2ML
1MG/0.2ML
1MG/0.2ML

A074728 001 Aug 04, 1998

A078885 001 Mar 09, 2009

A075471 001 Oct 25, 2000

3.75MG
7.5MG/VIAL
11.25MG/VIAL
22.5MG/VIAL
30MG/VIAL
45MG/VIAL

N020011
N019732
N020708
N020517
N020517
N020517

002
001
001
001
002
003

Oct
Jan
Mar
Dec
May
Jun

26,
26,
07,
22,
30,
17,

1995

1989

1997

1995

1997

2011

7.5MG/VIAL
11.25MG/VIAL
11.25MG/VIAL
15MG/VIAL
30MG/VIAL

N020263
N020263
N020263
N020263
N020263

002
005
007
006
008

Apr
Jan
Aug
Jan
Aug

16,
21,
15,
21,
15,

1993

1994

2011

1994

2011

7.5MG/VIAL
22.5MG/VIAL
30MG/VIAL
45MG/VIAL

N021343
N021379
N021488
N021731

001
001
001
001

Jan
Jul
Feb
Dec

23,
24,
13,
14,

2002

2002

2003

2004

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

INJECTABLE, TABLET;INTRAMUSCULAR, ORAL

LUPANETA PACK

ABBVIE ENDOCRINE
3.75MG/VIAL,N/A;N/A,5MG
+
11.25MG/VIAL,N/A;N/A,5MG

N203696 001 Dec 14, 2012

N203696 002 Dec 14, 2012

LEVALBUTEROL HYDROCHLORIDE

SOLUTION;INHALATION

LEVALBUTEROL HYDROCHLORIDE

CIPLA LTD
AN
AN
AN
AN
MYLAN SPECLT

A078171
A078171
A078171
A077800

EQ
EQ
EQ
EQ

0.021% BASE
0.042% BASE
0.0103% BASE
0.0103% BASE

002
003
001
001

Dec
Dec
Dec
Mar

13,
13,
13,
15,

2013

2013

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-221(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LEVALBUTEROL HYDROCHLORIDE

SOLUTION;INHALATION

LEVALBUTEROL HYDROCHLORIDE

AN
AN
AN
AN
TEVA PARENTERAL
AN
TEVA PHARMS USA
AN
AN
AN
WATSON LABS INC
AN
AN
XOPENEX

AN
+ OAK PHARMS INC
AN
+
AN
+
AN
+

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

0.021% BASE
0.042% BASE
0.25% BASE
0.25% BASE
0.0103% BASE
0.021% BASE
0.042% BASE
0.0103% BASE
0.021% BASE
0.042% BASE

A077800
A077800
A078309
A200875
A090297
A090297
A090297
A077756
A077756
A077756

002
003
001
001
001
002
003
003
001
002

Mar
Mar
Mar
Sep
Apr
Apr
Apr
Apr
Apr
Apr

15,
15,
20,
11,
26,
26,
26,
09,
09,
09,

2013

2013

2009

2014

2013

2013

2013

2008

2008

2008

EQ
EQ
EQ
EQ

0.0103% BASE
0.021% BASE
0.042% BASE
0.25% BASE

N020837
N020837
N020837
N020837

003
001
002
004

Jan
Mar
Mar
Jul

30,
25,
25,
18,

2002

1999

1999

2003

LEVALBUTEROL TARTRATE

AEROSOL, METERED;INHALATION

XOPENEX HFA

+ SUNOVION

EQ 0.045MG BASE/INH

LEVETIRACETAM

INJECTABLE;IV (INFUSION)

KEPPRA

AP
+ UCB INC
500MG/5ML (100MG/ML)
LEVETIRACETAM

AP
FRESENIUS KABI USA
500MG/5ML (100MG/ML)
AP
500MG/5ML (100MG/ML)
AP
HIKMA FARMACEUTICA
500MG/5ML (100MG/ML)
AP
HOSPIRA INC
500MG/5ML (100MG/ML)
AP
LUITPOLD
500MG/5ML (100MG/ML)
AP
SAGENT PHARMS
500MG/5ML (100MG/ML)
AP
SUN PHARM INDS LTD
500MG/5ML (100MG/ML)
AP
X GEN PHARMS
500MG/5ML (100MG/ML)
LEVETIRACETAM IN SODIUM CHLORIDE

+ HQ SPECIALITY PHARMA
500MG/100ML (5MG/ML)
+
1000MG/100ML (10MG/ML)
+
1500MG/100ML (15MG/ML)
SOLUTION;ORAL

KEPPRA

AA
+ UCB INC
100MG/ML
LEVETIRACETAM

AA
ACTAVIS MID ATLANTIC
100MG/ML
AA
AMNEAL PHARMS
100MG/ML
AA
AUROBINDO PHARM
100MG/ML
AA
BRECKENRIDGE PHARM
100MG/ML
AA
HETERO LABS LTD III
100MG/ML
AA
HI-TECH PHARMACAL
100MG/ML
AA
LUPIN LTD
100MG/ML
AA
ORIT LABS LLC
100MG/ML
AA
PHARM ASSOC
100MG/ML
AA
ROXANE
100MG/ML
AA
SILARX
100MG/ML
AA
TARO
100MG/ML
AA
TOLMAR
100MG/ML
AA
TRIS PHARMA INC
100MG/ML
AA
VINTAGE PHARMS
100MG/ML
AA
WOCKHARDT
100MG/ML
TABLET;ORAL

KEPPRA

AB
UCB INC
250MG
AB
500MG
AB
750MG
AB
+
1GM
LEVETIRACETAM

AB
ACCORD HLTHCARE
250MG
AB
500MG
AB
750MG
AB
1GM
AB
AJANTA PHARMA
250MG

N021730 001 Mar 11, 2005

N021872 001 Jul 31, 2006

A090813
A090876
A090981
A202869
A202143
A091627
A090754
A091485

001
001
001
001
001
001
001
001

May
Aug
Oct
Apr
Jan
Jun
Jun
Aug

26,
13,
13,
06,
31,
26,
16,
05,

2010

2015

2011

2012

2012

2013

2010

2011

N202543 001 Nov 09, 2011

N202543 002 Nov 09, 2011

N202543 003 Nov 09, 2011

N021505 001 Jul 15, 2003

A078976
A090992
A079063
A079120
A203052
A090601
A090893
A203067
A201157
A078582
A090263
A078774
A079107
A090461
A090079
A090028

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jan
Oct
Jan
Jan
Feb
Feb
Oct
May
Jun
Jan
Apr
Feb
Jan
Sep
Apr
Mar

15,
27,
15,
16,
28,
28,
17,
09,
04,
15,
03,
10,
15,
30,
11,
03,

2009

2009

2009

2009

2013

2012

2011

2013

2015

2009

2009

2009

2009

2010

2012

2010

N021035
N021035
N021035
N021035

001
002
003
004

Nov
Nov
Nov
Jan

30,
30,
30,
06,

1999

1999

1999

2006

A090843
A090843
A090843
A090843
A201293

001
002
003
004
001

Feb
Feb
Feb
Feb
Jun

14,
14,
14,
14,
14,

2011

2011

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-222(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LEVETIRACETAM

TABLET;ORAL

LEVETIRACETAM

AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
BRECKENRIDGE PHARM
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
HETERO LABS LTD III
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
LOTUS PHARM CO LTD
AB
LUPIN
AB
AB
AB
AB
METHAPHARM
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
ORCHID HLTHCARE
AB
AB
AB
AB
PRINSTON INC
AB
AB
AB
AB
ROXANE
AB
AB
AB
AB
SECAN PHARMS
AB
AB
AB
TARO
AB
AB
AB
AB
TEVA PHARMS
AB
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
AB
VINTAGE PHARMS
AB
AB

500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
500MG
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
250MG
500MG

A201293
A201293
A201293
A078869
A078869
A078869
A078869
A078993
A078993
A078993
A078993
A090511
A090511
A090511
A090511
A076920
A076920
A076920
A078904
A090515
A090515
A090515
A090515
A078234
A078234
A078234
A090906
A078154
A078154
A078154
A090025
A090767
A090767
A090767
A090767
A076919
A076919
A076919
A090261
A078526
A078526
A078526
A090484
A078106
A078106
A078106
A078106
A078042
A078042
A078042
A078042
A205102
A205102
A205102
A078960
A078960
A078960
A078960
A078101
A078101
A078101
A078101
A078858
A078858
A078858
A078858
A077319
A091491
A077319

002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
001
002
003
004
001
002
003
001
001
002
003
001
001
002
003
004
001
002
003
001
001
002
003
001
001
002
003
004
001
002
003
004
001
002
003
004
003
002
001
001
002
003
004
001
002
003
004
001
001
002

Jun
Jun
Jun
Mar
Mar
Mar
Mar
Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Nov
Jan
Jan
Jan
Jan
Jul
Jul
Jul
Jul
Nov
Nov
Nov
Dec
Jan
Jan
Jan
Aug
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Dec
Dec
Dec
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Mar
Dec
Mar

14,
14,
14,
13,
13,
13,
13,
15,
15,
15,
15,
18,
18,
18,
18,
15,
15,
15,
15,
08,
08,
08,
08,
15,
15,
15,
05,
15,
15,
15,
15,
28,
28,
28,
28,
04,
04,
04,
08,
15,
15,
15,
05,
10,
10,
10,
10,
15,
15,
15,
15,
16,
16,
16,
01,
01,
01,
01,
15,
15,
15,
15,
15,
15,
15,
15,
20,
14,
20,

2011

2011

2011

2009

2009

2009

2009

2009

2009

2009

2009

2011

2011

2011

2011

2009

2009

2009

2009

2010

2010

2010

2010

2009

2009

2009

2010

2009

2009

2009

2009

2010

2010

2010

2010

2008

2008

2008

2009

2009

2009

2009

2010

2009

2009

2009

2009

2009

2009

2009

2009

2015

2015

2015

2010

2010

2010

2010

2009

2009

2009

2009

2009

2009

2009

2009

2009

2010

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-223(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LEVETIRACETAM

TABLET;ORAL

LEVETIRACETAM
AB
AB
AB
AB
AB
WOCKHARDT
AB
AB
AB
AB
ZYDUS PHARMS USA INC
AB
SPRITAM
APRECIA PHARMS CO

500MG

750MG

750MG

1GM

250MG

500MG

750MG

1GM

250MG

1GM

A091491
A077319
A091491
A091491
A079042
A079042
A079042
A079042
A078918
A078918

002
003
003
004
001
002
003
004
001
002

Dec
Mar
Dec
Dec
Jan
Jan
Jan
Jan
Apr
Apr

14,
20,
14,
14,
15,
15,
15,
15,
29,
29,

2010

2009

2010

2010

2009

2009

2009

2009

2009

2009

250MG

500MG

750MG

1GM

N207958
N207958
N207958
N207958

001
002
003
004

Jul
Jul
Jul
Jul

31,
31,
31,
31,

2015

2015

2015

2015

TABLET, EXTENDED RELEASE;ORAL

KEPPRA XR

AB
UCB INC

500MG

AB
+

750MG

LEVETIRACETAM

AB
ACTAVIS ELIZABETH

500MG

AB

750MG

AB
ACTAVIS LABS FL INC

500MG

AB

750MG

AB
ANCHEN PHARMS

500MG

AB

750MG

AB
APOTEX INC

500MG

AB

750MG

AB
DEXCEL PHARMA

500MG

AB

750MG

AB
LUPIN LTD

500MG

AB

750MG

AB
MUTUAL PHARM CO INC

500MG

AB

750MG

AB
MYLAN PHARMS INC

500MG

AB

750MG

AB
PAR PHARM

500MG

AB

750MG

AB
PHARMADAX INC

500MG

AB

750MG

AB
PRINSTON INC

500MG

AB

750MG

AB
ROUSES POINT PHARMS

500MG

AB

750MG

AB
SUN PHARMA GLOBAL

500MG

AB

750MG

AB
TEVA PHARMS

500MG

AB

750MG

AB
TORRENT PHARMS LTD

500MG

AB

750MG

AB
VINTAGE PHARMS LLC

500MG

AB

750MG

APOTEX INC

1GM

MYLAN PHARMS INC

1GM

LEVOBUNOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AKBETA

AT
AKORN

AT

BETAGAN

AT
+ ALLERGAN

AT
+

LEVOBUNOLOL HYDROCHLORIDE

AT
ALCON RES LTD

AT
BAUSCH AND LOMB

AT

AT
FALCON PHARMS

N022285 001 Sep 12, 2008

N022285 002 Feb 12, 2009

A091557
A091557
A091093
A091093
A091360
A091360
A091261
A091261
A202167
A202167
A091399
A091399
A091285
A091285
A200475
A200475
A091291
A091291
A201464
A201464
A203468
A203468
A202524
A202524
A203059
A203059
A091430
A091430
A091338
A091338
A202533
A202533
A202958
A200475

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
003

Sep
Sep
Sep
Sep
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Dec
Dec
Sep
Sep
May
May
May
May
Aug
Aug
Sep
Sep
Sep
Sep
May
May
Jul
Jul
Feb
Dec

12,
12,
12,
12,
04,
04,
12,
12,
04,
04,
12,
12,
12,
12,
19,
19,
12,
12,
25,
25,
21,
21,
27,
27,
09,
09,
12,
12,
29,
29,
20,
20,
25,
07,

2011

2011

2011

2011

2011

2011

2011

2011

2015

2015

2011

2011

2011

2011

2011

2011

2011

2011

2012

2012

2015

2015

2012

2012

2013

2013

2011

2011

2012

2012

2012

2012

2015

2015

0.25%

0.5%

A074779 001 Oct 29, 1996

A074780 001 Oct 29, 1996

0.25%

0.5%

N019814 001 Jun 28, 1989

N019219 002 Dec 19, 1985

0.5%

0.25%

0.5%

0.25%

A074850
A074307
A074326
A074851

001
001
001
001

Oct
Mar
Mar
Oct

28,
04,
04,
28,

1996

1994

1994

1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-224(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LEVOCARNITINE

INJECTABLE;INJECTION

CARNITOR

AP
+ SIGMA TAU
LEVOCARNITINE

AP
EUROHLTH INTL SARL
AP
LUITPOLD
SOLUTION;ORAL

CARNITOR

AA
+ SIGMA TAU
CARNITOR SF

AA
SIGMA TAU
LEVOCARNITINE

AA
HI TECH PHARMA
AA
LYNE
TABLET;ORAL

CARNITOR

AB
+ SIGMA TAU
LEVOCARNITINE

AB
COREPHARMA

200MG/ML

N020182 001 Dec 16, 1992

200MG/ML
200MG/ML

A075567 001 Mar 29, 2001

A075861 001 Jun 22, 2001

1GM/10ML

N019257 001 Apr 10, 1986

1GM/10ML

N019257 002 Mar 28, 2007

1GM/10ML
1GM/10ML

A077399 001 Oct 25, 2007

A076851 001 Aug 10, 2004

330MG

N018948 001 Dec 27, 1985

330MG

A076858 001 Sep 20, 2004

LEVOCETIRIZINE DIHYDROCHLORIDE

SOLUTION;ORAL

LEVOCETIRIZINE DIHYDROCHLORIDE

AA
APOTEX INC
2.5MG/5ML
AA
L PERRIGO CO
2.5MG/5ML
AA
TARO PHARM INDS
2.5MG/5ML
XYZAL

AA
+ UCB INC
2.5MG/5ML
TABLET;ORAL

LEVOCETIRIZINE DIHYDROCHLORIDE

AB
APOTEX INC
5MG
AB
DR REDDYS LABS LTD
5MG
AB
GLENMARK GENERICS
5MG
AB
HETERO LABS LTD III
5MG
AB
MACLEODS PHARMS LTD
5MG
AB
MICRO LABS LTD INDIA
5MG
AB
SCIEGEN PHARMS INC
5MG
AB
SUN PHARM INDS LTD
5MG
AB
SUN PHARMA GLOBAL
5MG
AB
SYNTHON PHARMS
5MG
AB
TEVA PHARMS
5MG
XYZAL

AB
+ UCB INC
5MG
LEVOFLOXACIN

INJECTABLE;INJECTION

LEVAQUIN

AP
+ JANSSEN PHARMS
EQ 500MG/20ML (EQ 25MG/ML)
AP
+
EQ 750MG/30ML (EQ 25MG/ML)
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ JANSSEN PHARMS
EQ 250MG/50ML (EQ 5MG/ML)
AP
+
EQ 500MG/100ML (EQ 5MG/ML)
AP
+
EQ 750MG/150ML (EQ 5MG/ML)
LEVOFLOXACIN

AP
AUROBINDO PHARMA LTD
EQ 500MG/20ML (EQ 25MG/ML)
AP
EQ 750MG/30ML (EQ 25MG/ML)
AP
CLARIS PHARMASERVICE
EQ 500MG/20ML (EQ 25MG/ML)
AP
EMCURE PHARMS LTD
EQ 500MG/20ML (EQ 25MG/ML)
AP
EQ 750MG/30ML (EQ 25MG/ML)
AP
HOSPIRA INC
EQ 500MG/20ML (EQ 25MG/ML)
AP
EQ 750MG/30ML (EQ 25MG/ML)
AP
SAGENT PHARMS
EQ 500MG/20ML (EQ 25MG/ML)
AP
EQ 750MG/30ML (EQ 25MG/ML)
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
ACS DOBFAR INFO SA
EQ 250MG/50ML (EQ 5MG/ML)
AP
EQ 500MG/100ML (EQ 5MG/ML)
AP
EQ 750MG/150ML (EQ 5MG/ML)
AP
CLARIS PHARMASERVICE
EQ 250MG/50ML (EQ 5MG/ML)
AP
EQ 500MG/100ML (EQ 5MG/ML)
AP
EQ 750MG/150ML (EQ 5MG/ML)
AP
FRESENIUS KABI USA
EQ 250MG/50ML (EQ 5MG/ML)
AP
EQ 500MG/100ML (EQ 5MG/ML)

A202915 001 Aug 21, 2014

A091263 001 Nov 07, 2011

A202673 001 Jul 26, 2013

N022157 001 Jan 28, 2008

A203027
A090392
A090385
A091264
A205564
A202046
A203646
A201653
A090362
A090229
A090199

001
001
001
001
001
001
001
001
001
001
001

Feb
Feb
Feb
Jun
Jan
Sep
Sep
Jun
Jan
Nov
Aug

13,
24,
24,
29,
11,
17,
09,
26,
31,
26,
22,

2015

2011

2011

2012

2016

2013

2014

2015

2013

2010

2011

N022064 001 May 25, 2007

N020635 001 Dec 20, 1996

N020635 004 Dec 20, 1996

N020635 002 Dec 20, 1996

N020635 003 Dec 20, 1996

N020635 005 Dec 20, 1996

A202328
A202328
A091436
A202590
A202590
A078577
A078577
A200560
A200560

001
002
001
001
002
001
002
001
002

Jan
Jan
Jun
Jan
Jan
Aug
Aug
Jun
Jun

24,
24,
05,
24,
24,
12,
12,
20,
20,

2013

2013

2013

2013

2013

2015

2015

2011

2011

A090343
A090343
A090343
A091397
A091397
A091397
A200674
A200674

001
002
003
001
002
003
001
002

Jul
Jul
Jul
Aug
Aug
Aug
Jun
Jun

07,
07,
07,
08,
08,
08,
19,
19,

2011

2011

2011

2013

2013

2013

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-225(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LEVOFLOXACIN

INJECTABLE;INJECTION

LEVOFLOXACIN IN DEXTROSE 5%
AP

AP
HIKMA FARMACEUTICA

AP

AP

AP
HOSPIRA INC

AP

AP

SOLUTION;ORAL

LEVAQUIN

AA
+ JANSSEN PHARMS

LEVOFLOXACIN

AA
HI TECH PHARMA

SOLUTION/DROPS;OPHTHALMIC

LEVOFLOXACIN

AT
AKORN
AT
+ NEXUS PHARMS
AT
WATSON LABS INC
TABLET;ORAL

LEVAQUIN

AB
JANSSEN PHARMS

AB

AB
+

LEVOFLOXACIN

AB
APOTEX INC

AB

AB

AB
AUROBINDO PHARMA LTD

AB

AB

AB
CIPLA LTD

AB

AB

AB
DR REDDYS LABS INC

AB

AB

AB
GLENMARK GENERICS

AB

AB

AB
HETERO LABS LTD V

AB

AB

AB
JUBILANT GENERICS

AB

AB
LUPIN

AB

AB

AB
MACLEODS PHARMS LTD

AB

AB

AB
MYLAN

AB

AB

AB
ORCHID HLTHCARE

AB

AB

AB
SANDOZ

AB

AB

AB
TEVA

AB

AB

AB
TORRENT PHARMS

AB

AB

AB
WOCKHARDT

AB

AB

AB
ZYDUS PHARMS USA INC

AB

IN
EQ
EQ
EQ
EQ
EQ
EQ
EQ

PLASTIC CONTAINER

750MG/150ML (EQ 5MG/ML)

250MG/50ML (EQ 5MG/ML)

500MG/100ML (EQ5MG/ML)

750MG/150ML (EQ 5MG/ML)

250MG/50ML (EQ 5MG/ML)

500MG/100ML (EQ 5MG/ML)

750MG/150ML (EQ 5MG/ML)

A200674
A091375
A091375
A091375
A078579
A078579
A078579

003
001
002
003
001
002
003

Jun
Sep
Sep
Sep
Sep
Sep
Sep

19,
16,
16,
16,
03,
03,
03,

2013

2011

2011

2011

2015

2015

2015

250MG/10ML

N021721 001 Oct 21, 2004

250MG/10ML

A091678 001 Jun 20, 2011

0.5%

0.5%

0.5%

A090268 001 Dec 20, 2010

A077700 001 Dec 20, 2010

A076826 001 Feb 10, 2011

250MG

500MG

750MG

N020634 001 Dec 20, 1996

N020634 002 Dec 20, 1996

N020634 003 Sep 08, 2000

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

750MG

250MG

500MG

A090787
A090787
A090787
A201043
A201043
A201043
A076890
A076890
A076890
A076710
A076710
A076710
A200250
A200250
A200250
A202801
A202801
A202801
A203613
A203613
A078424
A078424
A078424
A200839
A200839
A200839
A076276
A076276
A077097
A202200
A202200
A202200
A077438
A077438
A077438
A076361
A076361
A076361
A090722
A090722
A090722
A090367
A090367
A090367
A077652
A077652

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
001
002
003
001
002
003
001
002
001
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002

Sep
Sep
Sep
Jun
Jun
Jun
Mar
Mar
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Jun
Jun
Jun
Jun
Jun
Mar
Mar
Mar
Jun
Jun
Jun
Jan
Jan
Jan
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Sep
Sep

29,
29,
29,
20,
20,
20,
30,
30,
30,
20,
20,
20,
20,
20,
20,
08,
08,
08,
19,
19,
20,
20,
20,
22,
22,
22,
20,
20,
20,
30,
30,
30,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
07,
07,

2011

2011

2011

2011

2011

2011

2012

2012

2012

2011

2011

2011

2011

2011

2011

2015

2015

2015

2015

2015

2011

2011

2011

2012

2012

2012

2011

2011

2011

2012

2012

2012

2011

2011

2011

2011

2011

2011

2011

2011

2011

2011

2011

2011

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-226(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LEVOFLOXACIN

TABLET;ORAL

LEVOFLOXACIN

AB
LEVOLEUCOVORIN CALCIUM

POWDER;IV (INFUSION)

FUSILEV

+ SPECTRUM PHARMS
SOLUTION;IV (INFUSION)

LEVOLEUCOVORIN CALCIUM

AP
MYLAN TEORANTA
AP
AP
SANDOZ INC
AP
+

750MG

A077652 003 Sep 07, 2012

EQ 50MG BASE/VIAL

N020140 001 Mar 07, 2008

EQ
EQ
EQ
EQ

A203576
A203576
A203563
A203563

001
002
001
002

Oct
Oct
Mar
Mar

20,
20,
09,
09,

2015

2015

2015

2015

N204168
N204168
N204168
N204168

001
002
003
004

Jul
Jul
Jul
Jul

25,
25,
25,
25,

2013

2013

2013

2013

LEVOMILNACIPRAN HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

FETZIMA

FOREST LABS INC
EQ
EQ
EQ
+
EQ

175MG
250MG
175MG
250MG

BASE/17.5ML (EQ 10MG BASE/ML)

BASE/25ML (EQ 10MG BASE/ML)
BASE/17.5ML (EQ 10MG BASE/ML)
BASE/25ML (EQ 10MG BASE/ML)

20MG BASE
40MG BASE
80MG BASE
120MG BASE

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

SCANDONEST L

+ DEPROCO
0.05MG/ML;2%

A088388 001 Oct 10, 1984

LEVONORGESTREL

INTRAUTERINE DEVICE;INTRAUTERINE

LILETTA

MEDICINES360
52MG
MIRENA

+ BAYER HLTHCARE
52MG
SKYLA

+ BAYER HLTHCARE
13.5MG
TABLET;ORAL

LEVONORGESTREL

AB
NOVEL LABS INC
1.5MG
AB
PERRIGO R AND D
0.75MG
AB
+ WATSON LABS
0.75MG
AB
WATSON LABS INC
1.5MG
PLAN B

AB
+ TEVA BRANDED PHARM
0.75MG

N021045 002 Aug 24, 2006

LEVORPHANOL TARTRATE

TABLET;ORAL

LEVORPHANOL TARTRATE

+ SENTYNL THERAPS INC

2MG

A074278 001 Mar 31, 2000

0.013MG
0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG

N022121
N021924
N021924
N021924
N021924
N021924
N021924
N021924
N021924
N021924

001
002
003
004
010
005
008
006
009
007

Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

01,
13,
13,
13,
02,
13,
02,
13,
02,
13,

2007

2006

2006

2006

2009

2006

2009

2006

2009

2006

200MCG/VIAL
200MCG/VIAL
100MCG/VIAL
500MCG/VIAL

N202231
A205366
N202231
N202231

002
001
001
003

Jun
Dec
Jun
Jun

24,
07,
24,
24,

2011

2015

2011

2011

LEVOTHYROXINE SODIUM

CAPSULE;ORAL

TIROSINT

INST BIOCHIMIQUE
INSTITUT BIOCHIMIQUE

+
POWDER;INTRAVENOUS

LEVOTHYROXINE SODIUM

AP
+ FRESENIUS KABI USA
AP
PAR STERILE PRODUCTS
+ FRESENIUS KABI USA
+

N206229 001 Feb 26, 2015

N021225 001 Dec 06, 2000

N203159 001 Jan 09, 2013

A202508
A090740
A078665
A200670

001
001
001
001

Feb
Dec
Aug
Jul

22,
30,
28,
12,

2013

2010

2009

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-227(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LEVOTHYROXINE SODIUM **

**See current Annual Edition, 1.8 Description of
TABLET;ORAL

SYNTHROID

-->
ABBVIE
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
-->
--> AB1,AB2
--> +
--> AB1,AB2
LEVO-T
-->
ALARA PHARM
--> AB1,AB2,AB3

Special Situations, Levothyroxine Sodium

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG

N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402

0.025MG

N021342 001 Mar 01, 2002

001
002
003
004
005
006
007
008
009
010
012
011

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,

2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002

-->

--> AB1,AB2,AB3

0.05MG

N021342 002 Mar 01, 2002

-->

--> AB1,AB2,AB3

0.075MG

N021342 003 Mar 01, 2002

-->

--> AB1,AB2,AB3

0.088MG

N021342 004 Mar 01, 2002

-->

--> AB1,AB2,AB3

0.1MG

N021342 005 Mar 01, 2002

-->

--> AB1,AB2,AB3

0.112MG

N021342 006 Mar 01, 2002

-->

--> AB1,AB2,AB3

0.125MG

N021342 007 Mar 01, 2002

-->

--> AB1,AB2,AB3

0.137MG

N021342 012 Dec 08, 2003

-->

--> AB1,AB2,AB3

0.15MG

N021342 008 Mar 01, 2002

-->

--> AB1,AB2,AB3

0.175MG

N021342 009 Mar 01, 2002

-->

--> AB1,AB2,AB3

0.2MG

N021342 010 Mar 01, 2002

--> AB1,AB2,AB3

0.3MG

N021342 011 Mar 01, 2002

--> AB1,AB2,AB3

0.025MG

N021210 001 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.05MG

N021210 002 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.075MG

N021210 003 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.088MG

N021210 004 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.1MG

N021210 005 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.112MG

N021210 006 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.125MG

N021210 007 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.137MG

N021210 012 Feb 08, 2008

-->

--> AB1,AB2,AB3

0.15MG

N021210 008 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.175MG

N021210 009 Aug 21, 2000

-->

--> AB1,AB2,AB3

0.2MG

N021210 010 Aug 21, 2000

--> AB1,AB2,AB3

0.3MG

N021210 011 Aug 21, 2000

-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
--> AB1,AB2,

0.025MG

A076187 001 Jun 05, 2002

0.05MG

A076187 002 Jun 05, 2002

0.075MG

A076187 003 Jun 05, 2002

0.088MG

A076187 004 Jun 05, 2002

0.1MG

A076187 005 Jun 05, 2002

0.112MG

A076187 006 Jun 05, 2002

-->

-->

-->

-->
-->
-->
-->
-->
-->

+
UNITHROID
STEVENS J

+
LEVOTHYROXINE SODIUM
MYLAN

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-228(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LEVOTHYROXINE SODIUM **

**See current Annual Edition, 1.8 Description of
TABLET;ORAL

LEVOTHYROXINE SODIUM

AB3,AB4
-->
-->
AB1,AB2,AB3,AB4
-->
-->
AB1,AB2,AB3,AB4
-->
-->
AB1,AB2,AB3,AB4
-->
-->
AB1,AB2,AB3,AB4
-->
-->
AB1,AB2,AB3,AB4
-->
-->
AB1,AB2,AB3,AB4
LEVOXYL
-->
KING PHARMS R AND D
--> AB1,AB3
-->
--> AB1,AB3
-->
--> AB1,AB3
-->
--> AB1,AB3
-->
--> AB1,AB3
-->
--> AB1,AB3
-->
--> AB1,AB3
-->
--> AB1,AB3
-->
--> AB1,AB3
-->
--> AB1,AB3
--> +
--> AB1,AB3
LEVOTHROID
AB4
LLOYD
0.025MG
AB4
0.05MG
AB4
0.075MG
AB4
0.088MG
AB4
0.1MG
AB4
0.112MG
AB4
0.125MG
AB4
0.137MG
AB4
0.15MG
AB4
0.175MG
AB4
0.2MG
AB4 +
0.3MG
LIDOCAINE
OINTMENT;TOPICAL
LIDOCAINE
AT
AMNEAL PHARMS
AT
+ FOUGERA
AT
NOVOCOL INC
AT
TARO
PATCH;TOPICAL
LIDOCAINE
AB
ACTAVIS LABS UT INC
AB
MYLAN TECHNOLOGIES
LIDODERM
AB
+ TEIKOKU PHARMA USA
LIDOCAINE HYDROCHLORIDE
GEL;OPHTHALMIC
AKTEN
+ AKORN
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE
AP
HOSPIRA
AP
AP
AP
AP
AP
AP
AP
INTL MEDICATION
AP
AP
LUITPOLD
AP
AP
MYLAN LABS LTD

Special Situations, Levothyroxine Sodium

0.112MG
0.125MG

A076187 007 Jun 05, 2002

0.137MG

A076187 012 Dec 13, 2006

0.15MG

A076187 008 Jun 05, 2002

0.175MG

A076187 009 Jun 05, 2002

0.2MG

A076187 010 Jun 05, 2002

0.3MG

A076187 011 Jun 05, 2002

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG

N021301
N021301
N021301
N021301
N021301
N021301
N021301
N021301
N021301
N021301
N021301

001
002
003
004
005
006
007
008
009
010
011

May
May
May
May
May
May
May
May
May
May
May

25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,

2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001

N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116

001
002
003
010
004
011
005
012
006
007
008
009

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Dec
Oct
Oct
Oct
Oct

24,
24,
24,
24,
24,
24,
24,
07,
24,
24,
24,
24,

2002
2002
2002
2002
2002
2002
2002
2004
2002
2002
2002
2002

5%
5%
5%
5%

A206297
A080198
A040911
A086724

001 Aug 07, 2015

001
001 May 23, 2011
001

5%
5%

A200675 001 Aug 23, 2012

A202346 001 Aug 07, 2015

5%

N020612 001 Mar 19, 1999

3.5%

N022221 001 Oct 07, 2008

0.5%
1%
1%
2%
2%
2%
20%
1%
2%
1%
1%
0.5%

A088328
A083158
A088329
A040078
A083158
A088294
A083158
A083173
A083173
A080850
A091564
A091056

001
001
001
001
002
001
003
001
002
001
001
001

May 17, 1984

May 17, 1984
Jun 23, 1995
May 17, 1984

Aug 14, 2015

Dec 08, 2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-229(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE

AP
0.5%
AP
1%
AP
1%
AP
2%
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

AP
B BRAUN
200MG/100ML
AP
BAXTER HLTHCARE
200MG/100ML
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

AP
B BRAUN
400MG/100ML
AP
BAXTER HLTHCARE
400MG/100ML
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP
HOSPIRA
400MG/100ML
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP
B BRAUN
800MG/100ML
AP
BAXTER HLTHCARE
800MG/100ML
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP
HOSPIRA
800MG/100ML
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

AP
FRESENIUS KABI USA
1%
AP
HOSPIRA
0.5%
AP
1%
AP
2%
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

AP
AUROBINDO PHARMA LTD
1%
AP
1%
AP
2%
AP
2%
AP
FRESENIUS KABI USA
1%
AP
2%
AP
2%
AP
4%
AP
HOSPIRA
1%
AP
1.5%
AP
4%
AP
INTL MEDICATION
20%
AP
MYLAN LABS LTD
2%
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER

AP
HOSPIRA
1%
AP
2%
XYLOCAINE

AP
+ FRESENIUS KABI USA
0.5%
AP
+
1%
AP
+
1.5%
AP
+
2%
XYLOCAINE 4% PRESERVATIVE FREE

AP
+ FRESENIUS KABI USA
4%
XYLOCAINE PRESERVATIVE FREE

AP
+ FRESENIUS KABI USA
1%
AP
+
2%
AP
+
4%
AP
+
20%
INJECTABLE;SPINAL

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%

+ HOSPIRA
5%
JELLY;TOPICAL

GLYDO

AT
SAGENT PHARMS
2%
LIDOCAINE HYDROCHLORIDE

AT
AKORN
2%
AT
INTL MEDICATION
2%
AT
WATSON LABS INC
2%
XYLOCAINE

AT
+ OAK PHARMS
2%
SOLUTION;ORAL

LIDOCAINE HYDROCHLORIDE

AT
HI TECH PHARMA
2%
AT
WOCKHARDT
2%
LIDOCAINE HYDROCHLORIDE VISCOUS

AT
VINTAGE
2%

A091058
A091056
A091058
A202242

001
002
002
001

Sep
Dec
Sep
Apr

30,
08,
30,
11,

2010

2010

2010

2014

N019830 002 Apr 08, 1992

N018461 002

N019830 003 Apr 08, 1992
N018461 003
N018388 002
N019830 004 Apr 08, 1992
N018461 004 Feb 22, 1982
N018388 003 Nov 05, 1982

A088586
A088325
A088299
A088327

001
001
001
001

Jul
Jul
Jul
Jul

24,
31,
31,
31,

1985

1984

1984

1984

A203040
A203082
A203040
A203082
A080404
A080404
N017584
N017584
A080408
A080408
A088295
N017702
A090665

001
001
002
002
002

003

001

002

001

002

001
001

001

Mar
Mar
Mar
Mar

14,
14,
14,
14,

2013

2013

2013

2013

May 17, 1984

Sep 27, 2010

A040302 001 Sep 28, 1998

A040302 002 Sep 28, 1998

N006488
N006488
N006488
N006488

008

007

010

002

N010417 001

N016801
N016801
N016801
N016801

005 Jan 19, 1988

001

002

004

A083914 001

A201094 001 Apr 28, 2014

A040433 001 Feb 12, 2003

A086283 001

A040837 001 Mar 23, 2011

N008816 001

A040014 001 Jul 10, 1995

A087872 001 Nov 18, 1982

A040708 001 Feb 27, 2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-230(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LIDOCAINE HYDROCHLORIDE

SOLUTION;ORAL

LIDOCAINE VISCOUS

AT
ROXANE
2%
XYLOCAINE VISCOUS

AT
+ FRESENIUS KABI USA
2%
SOLUTION;TOPICAL

LARYNG-O-JET KIT

AT
INTL MEDICATION
4%
LIDOCAINE HYDROCHLORIDE

AT
IGI LABS INC
4%
AT
ROXANE
4%
AT
VINTAGE
4%
AT
WOCKHARDT
4%
LTA II KIT

AT
HOSPIRA
4%
XYLOCAINE 4% PRESERVATIVE FREE

AT
+ FRESENIUS KABI USA
4%
SYSTEM;INTRADERMAL

ZINGO

POWDER PHARMS
0.5MG
LIDOCAINE; PRILOCAINE

CREAM;TOPICAL

EMLA

AB
+ ACTAVIS LABS UT INC
LIDOCAINE AND PRILOCAINE

AB
FOUGERA PHARMS
AB
HI TECH PHARMA
AB
TOLMAR
GEL;PERIODONTAL

ORAQIX

+ DENTSPLY PHARM

A088802 001 Apr 26, 1985

N009470 001

A086364 001

A204494
A088803
A040710
A087881

001
001
001
001

Mar
Apr
Feb
Nov

12,
03,
27,
18,

2014

1985

2007

1982

A080409 001

N010417 002

N022114 001 Aug 16, 2007

2.5%;2.5%

N019941 001 Dec 30, 1992

2.5%;2.5%
2.5%;2.5%
2.5%;2.5%

A076453 001 Aug 18, 2003

A076290 001 Sep 25, 2003

A076320 001 Aug 27, 2003

2.5%;2.5%

N021451 001 Dec 19, 2003

LIDOCAINE; TETRACAINE

CREAM;TOPICAL

PLIAGLIS

+ GALDERMA LABS LP
PATCH;TOPICAL

SYNERA

+ GALEN SPECIALTY

7%;7%

N021717 001 Jun 29, 2006

70MG;70MG

N021623 001 Jun 23, 2005

LINACLOTIDE

CAPSULE;ORAL

LINZESS

FOREST LABS LLC
+

145MCG
290MCG

N202811 001 Aug 30, 2012

N202811 002 Aug 30, 2012

LINAGLIPTIN

TABLET;ORAL

TRADJENTA

+ BOEHRINGER INGELHEIM

5MG

N201280 001 May 02, 2011

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

TABLET;ORAL

JENTADUETO

BOEHRINGER INGELHEIM
2.5MG;500MG
2.5MG;850MG
+
2.5MG;1GM
LINCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

LINCOCIN

AP
+ PHARMACIA AND UPJOHN
LINCOMYCIN

AP
X-GEN PHARMS INC
LINDANE

LOTION;TOPICAL

LINDANE

AT
OLTA PHARMS
AT
+ WOCKHARDT
SHAMPOO;TOPICAL

LINDANE

AT
OLTA PHARMS
AT
+ WOCKHARDT

N201281 001 Jan 30, 2012

N201281 002 Jan 30, 2012

N201281 003 Jan 30, 2012

EQ 300MG BASE/ML

N050317 001

EQ 300MG BASE/ML

A201746 001 Jun 04, 2015

1%
1%

A087313 001

A088190 001 Aug 16, 1984

1%
1%

A087266 001

A088191 001 Sep 18, 1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-231(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LINEZOLID

FOR SUSPENSION;ORAL

LINEZOLID

AB
ROXANE
100MG/5ML
ZYVOX

AB
+ PHARMACIA AND UPJOHN
100MG/5ML
SOLUTION;IV (INFUSION)

LINEZOLID

AP
HOSPIRA INC
600MG/300ML (2MG/ML)
AP
SANDOZ INC
200MG/100ML (2MG/ML)
AP
600MG/300ML (2MG/ML)
AP
TEVA PHARMS
600MG/300ML (2MG/ML)
ZYVOX

AP
PHARMACIA AND UPJOHN
200MG/100ML (2MG/ML)
AP
+
600MG/300ML (2MG/ML)
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ HOSPIRA INC
600MG/300ML (2MG/ML)
ZYVOX

PHARMACIA AND UPJOHN
400MG/200ML (2MG/ML)
TABLET;ORAL

LINEZOLID

AB
ALEMBIC PHARMS LTD
600MG
AB
ALKEM LABS LTD
600MG
AB
AMNEAL PHARMS
600MG
AB
GLENMARK PHARMS LTD
600MG
AB
HETERO LABS LTD V
600MG
AB
MYLAN PHARMS INC
600MG
AB
TEVA PHARMS USA
600MG
ZYVOX

AB
+ PHARMACIA AND UPJOHN
600MG
LIOTHYRONINE SODIUM

INJECTABLE;INJECTION

LIOTHYRONINE SODIUM

AP
X GEN PHARMS
TRIOSTAT

AP
+ PAR STERILE PRODUCTS
TABLET;ORAL

CYTOMEL

AB
KING PHARMS R AND D
AB
AB
+
LIOTHYRONINE SODIUM

AB
COASTAL PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
SIGMAPHARM LABS LLC
AB
AB
LIOTRIX (T4;T3)

TABLET;ORAL

THYROLAR-0.25

FOREST LABS
THYROLAR-0.5

FOREST LABS
THYROLAR-1

FOREST LABS
THYROLAR-2

FOREST LABS
THYROLAR-3

+ FOREST LABS
LIRAGLUTIDE RECOMBINANT

SOLUTION;SUBCUTANEOUS

SAXENDA

+ NOVO NORDISK INC
VICTOZA

+ NOVO NORDISK INC

A200068 001 Jun 03, 2015

N021132 001 Apr 18, 2000

A205442
A200904
A200904
A200222

001
001
002
001

Jul
Jul
Jul
Jun

07,
16,
16,
27,

2015

2015

2015

2012

N021131 001 Apr 18, 2000

N021131 003 Apr 18, 2000

N206473 001 Jun 18, 2015

N021131 002 Apr 18, 2000

A205233
A205517
A204536
A078987
A204239
A078845
A078061

001
001
001
001
001
001
001

Dec
Dec
Dec
Dec
Dec
Dec
May

21,
21,
21,
21,
21,
21,
18,

2015

2015

2015

2015

2015

2015

2015

N021130 002 Apr 18, 2000

EQ 0.01MG BASE/ML

A076923 001 Aug 17, 2005

EQ 0.01MG BASE/ML

N020105 001 Dec 31, 1991

EQ 0.005MG BASE
EQ 0.025MG BASE
EQ 0.05MG BASE

N010379 001

N010379 002

N010379 003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A090097
A090097
A090097
A090326
A090326
A090326
A200295
A200295
A200295

0.005MG BASE
0.025MG BASE
0.05MG BASE
0.005MG BASE
0.025MG BASE
0.05MG BASE
0.005MG BASE
0.025MG BASE
0.05MG BASE

001
002
003
001
002
003
001
002
003

Mar
Mar
Mar
Jul
Jul
Jul
Nov
Nov
Nov

20,
20,
20,
14,
14,
14,
29,
29,
29,

2009

2009

2009

2009

2009

2009

2012

2012

2012

0.0031MG;0.0125MG

N016807 001

0.0063MG;0.025MG

N016807 005

0.0125MG;0.05MG

N016807 004

0.025MG;0.1MG

N016807 002

0.0375MG;0.15MG

N016807 003

18MG/3ML (6MG/ML)

N206321 001 Dec 23, 2014

18MG/3ML (6MG/ML)

N022341 001 Jan 25, 2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-232(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LISDEXAMFETAMINE DIMESYLATE

CAPSULE;ORAL

VYVANSE

SHIRE DEVELOPMENT

+

LISINOPRIL

TABLET;ORAL

LISINOPRIL
AB
ACCORD HLTHCARE
AB
AB
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AB
AB
AUROBINDO
AB
AB
AB
AB
AB
AB
HIKMA INTL PHARMS
AB
AB
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
AB
AB
LUPIN
AB
AB
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
PRINSTON INC
AB
AB
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB

10MG

20MG

30MG

40MG

50MG

60MG

70MG

N021977
N021977
N021977
N021977
N021977
N021977
N021977

007
004
001
005
002
006
003

Oct
Dec
Feb
Dec
Feb
Dec
Feb

30,
10,
23,
10,
23,
10,
23,

2014

2007

2007

2007

2007

2007

2007

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

A202554
A202554
A202554
A202554
A202554
A202554
A076102
A076102
A076102
A076102
A076102
A076102
A077622
A077622
A077622
A077622
A077622
A077622
A076063
A076063
A076063
A076063
A076063
A076063
A203508
A203508
A203508
A203508
A203508
A203508
A075752
A075752
A075752
A075752
A075752
A075752
A077321
A077321
A077321
A077321
A077321
A077321
A076071
A076071
A076071
A076071
A076071
A076071
A076180
A076180
A076180
A076164
A076164
A076164
A075994
A075994
A075994
A075994
A075994

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
006
005
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
001
002
003
001
002
003
004
005

Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Feb
Feb
Feb
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Jun
Jul
Oct
Oct
Oct
Oct
Oct
Oct
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
22,
22,
22,
22,
22,
22,
01,
01,
01,
01,
27,
01,
29,
29,
29,
29,
29,
29,
01,
01,
01,
01,
01,
01,
09,
09,
09,
09,
09,
09,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2013

2013

2013

2013

2013

2013

2002

2002

2002

2002

2002

2002

2006

2006

2006

2006

2006

2006

2002

2002

2002

2002

2003

2002

2013

2013

2013

2013

2013

2013

2002

2002

2002

2002

2002

2002

2005

2005

2005

2005

2005

2005

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-233(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LISINOPRIL

TABLET;ORAL

LISINOPRIL

AB
AB
SUN PHARM INDS LTD
AB
AB
AB
AB
AB
AB
VINTAGE
AB
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
AB
WOCKHARDT
AB
AB
AB
AB
AB
PRINIVIL

AB
MERCK
AB
AB
AB
ZESTRIL

AB
ALVOGEN IPCO SARL
AB
AB
AB
AB
AB
+

40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG

A075994
A075944
A075944
A075944
A075944
A075944
A075944
A075743
A075743
A075743
A075743
A075743
A075743
A076059
A076059
A076059
A076059
A076059
A076059
A078402
A078402
A078402
A078402
A078402
A078402

006
001
002
003
004
006
005
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006

Jul
Jul
Jul
Jul
Jul
Feb
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Apr
Apr
Apr
Apr
Apr
Apr

01,
01,
01,
01,
01,
11,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
19,
19,
19,
19,
19,
19,

2002

2002

2002

2002

2002

2003

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2007

2007

2007

2007

2007

2007

5MG
10MG
20MG
40MG

N019558
N019558
N019558
N019558

001
002
003
004

Dec
Dec
Dec
Oct

29,
29,
29,
25,

1987

1987

1987

1988

2.5MG
5MG
10MG
20MG
30MG
40MG

N019777
N019777
N019777
N019777
N019777
N019777

005
001
002
003
006
004

Apr
May
May
May
Jan
May

29,
19,
19,
19,
20,
19,

1993

1988

1988

1988

1999

1988

A079159
A079159
A079159
A079139
A079139
A079139
A090702
A090702
A090702
A076243
A076243
N017812
N017812
N017812

001
002
003
001
002
003
001
002
003
002
001
002
001

003

Jan
Jan
Jan
Feb
Feb
Feb
Sep
Sep
Sep
Feb
Jun
Jan

12,
12,
12,
03,
03,
03,
25,
25,
25,
24,
27,
28,

2009

2009

2009

2009

2009

2009

2009

2009

2009

2003

2002

1987

LITHIUM CARBONATE

CAPSULE;ORAL

LITHIUM CARBONATE

AB
ALEMBIC LTD
150MG
AB
300MG
AB
600MG
AB
GLENMARK GENERICS
150MG
AB
300MG
AB
600MG
AB
HETERO LABS LTD III
150MG
AB
300MG
AB
600MG
AB
HIKMA INTL PHARMS
150MG
AB
300MG
AB
ROXANE
150MG
AB
300MG
AB
+
600MG
TABLET;ORAL

LITHIUM CARBONATE

AB
+ ROXANE
300MG
300MG
AB
SUN PHARM INDS INC
TABLET, EXTENDED RELEASE;ORAL

LITHIUM CARBONATE

AB
ALEMBIC PHARMS LTD
300MG
AB
GLENMARK GENERICS
450MG
AB
GLENMARK PHARMS INC
300MG
AB
MYLAN PHARMS INC
300MG
AB
450MG
AB
ROXANE
300MG
AB
+
450MG
AB
UNIQUE PHARM LABS
300MG

Jan 28, 1987

N018558 001 Jan 29, 1982

A091027 001 Jun 24, 2010

A204445
A091616
A091544
A202288
A202219
A076832
A076691
A204779

001
001
001
001
001
001
001
001

Jun
Feb
Dec
Jun
Aug
Oct
Jan
Jul

10,
14,
27,
29,
08,
28,
05,
27,

2015

2011

2010

2012

2012

2004

2004

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-234(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LITHIUM CARBONATE

TABLET, EXTENDED RELEASE;ORAL

LITHOBID

AB
+ ANI PHARMS INC
300MG

N018027 001

LITHIUM CITRATE

SYRUP;ORAL

LITHIUM CITRATE

AA
+ ROXANE
AA
WOCKHARDT

EQ 300MG CARBONATE/5ML
EQ 300MG CARBONATE/5ML

N018421 001

A070755 001 May 21, 1986

LODOXAMIDE TROMETHAMINE

SOLUTION/DROPS;OPHTHALMIC

ALOMIDE

+ ALCON

EQ 0.1% BASE

N020191 001 Sep 23, 1993

EQ
EQ
EQ
EQ
EQ
EQ

N203858
N203858
N203858
N203858
N203858
N203858

001
002
003
004
005
006

5MG
10MG
40MG
100MG

N017588
N017588
N017588
N017588

004 Dec 19, 2014

001

002

003

2MG

N017694 001

2MG
2MG

A072741 001 Sep 18, 1991

A073192 001 Apr 30, 1992

80MG/ML;20MG/ML

N021251 001 Sep 15, 2000

100MG;25MG
200MG;50MG

N021906 002 Nov 09, 2007

N021906 001 Oct 28, 2005

LOMITAPIDE MESYLATE

CAPSULE;ORAL

JUXTAPID

AEGERION
+

LOMUSTINE

CAPSULE;ORAL

GLEOSTINE

CORDEN PHARMA

+
LOPERAMIDE HYDROCHLORIDE

CAPSULE;ORAL

IMODIUM

AB
+ J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE

AB
MYLAN
AB
TEVA
LOPINAVIR; RITONAVIR

SOLUTION;ORAL

KALETRA

+ ABBVIE
TABLET;ORAL

KALETRA

ABBVIE
+

5MG BASE
10MG BASE
20MG BASE
30MG BASE
40MG BASE
60MG BASE

LORAZEPAM

CONCENTRATE;ORAL

LORAZEPAM

AA
AMNEAL PHARMS
2MG/ML
AA
HI-TECH PHARMA CO
2MG/ML
AA
LUPIN LTD
2MG/ML
AA
PADDOCK LLC
2MG/ML
AA
PHARM ASSOC
2MG/ML
LORAZEPAM INTENSOL

AA
+ ROXANE
2MG/ML
INJECTABLE;INJECTION

ATIVAN

AP
+ EUROHLTH INTL SARL
2MG/ML
AP
+
4MG/ML
LORAZEPAM

AP
AKORN
2MG/ML
AP
HOSPIRA
2MG/ML
AP
2MG/ML
AP
4MG/ML
AP
4MG/ML
AP
INTL MEDICATION SYS
2MG/ML
LORAZEPAM PRESERVATIVE FREE

AP
BEDFORD LABS
2MG/ML
AP
4MG/ML

A091383
A200169
A091407
A079244
A090260

001
001
001
001
001

Dec
Dec
Dec
Apr
Apr
Apr

Dec
Jan
Feb
Apr
Jun

21,
21,
21,
23,
23,
23,

23,
30,
19,
28,
15,

2012
2012
2012
2015
2015
2015

2009

2012

2013

2009

2010

A072755 001 Jun 28, 1991

N018140 001

N018140 002

A075025
A074243
A074282
A074243
A074282
A076150

001
001
001
002
002
001

Jul
Apr
May
Apr
May
Nov

23,
12,
27,
12,
27,
15,

1998

1994

1994

1994

1994

2004

A077074 001 Jul 13, 2005

A077074 002 Jul 13, 2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-235(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LORAZEPAM

TABLET;ORAL

ATIVAN

AB
VALEANT INTL

AB

AB
+

LORAZEPAM

AB
AMNEAL PHARMS

AB

AB

AB
ANI PHARMS INC

AB

AB

AB
LEADING PHARMA LLC

AB

AB

AB
MYLAN

AB

AB

AB

AB

AB

AB
SANDOZ

AB

AB

AB
SUN PHARM INDS LTD

AB

AB

AB
VINTAGE PHARMS

AB

AB

AB
WATSON LABS

AB

AB

LORCASERIN HYDROCHLORIDE

TABLET;ORAL

BELVIQ

+ EISAI INC

LOSARTAN POTASSIUM

TABLET;ORAL

COZAAR

AB
MERCK SHARP DOHME

AB

AB
+

LOSARTAN POTASSIUM

AB
ALEMBIC PHARMS LTD

AB

AB

AB
APOTEX CORP

AB

AB

AB
AUROBINDO PHARMA

AB

AB

AB
CADISTA PHARMS

AB

AB

AB
HETERO LABS LTD V

AB

AB

AB
IPCA LABS LTD

AB

AB

AB
LUPIN LTD

AB

AB

AB
MACLEODS PHARMS LTD

AB

AB

AB
MICRO LABS LTD INDIA

AB

0.5MG

1MG

2MG

N017794 001

N017794 002

N017794 003

0.5MG

1MG

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

0.5MG

0.5MG

1MG

1MG

2MG

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

A078826
A078826
A078826
A077396
A077396
A077396
A078203
A078203
A078203
A071589
A077657
A071590
A077657
A071591
A077657
A071403
A071404
A071141
A076045
A076045
A076045
A077754
A077754
A077754
A072926
A072927
A072928

10MG

N022529 001 Jun 27, 2012

25MG

50MG

100MG

N020386 001 Apr 14, 1995

N020386 002 Apr 14, 1995

N020386 003 Oct 13, 1998

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

A090428
A090428
A090428
A090790
A090790
A090790
A090083
A090083
A090083
A201170
A201170
A201170
A203835
A203835
A203835
A200290
A200290
A200290
A078232
A078232
A078232
A202230
A202230
A202230
A091541
A091541

001
002
003
001
002
003
001
002
003
001
001
001
002
001
003
001
001
001
001
002
003
001
002
003
001
001
001

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002

Jun
Jun
Jun
Dec
Dec
Dec
Jul
Jul
Jul
Oct
Mar
Oct
Mar
Oct
Mar
Apr
Apr
Apr
Aug
Aug
Aug
May
May
May
Oct
Oct
Oct

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Oct
May
May
May
Sep
Sep

23,
23,
23,
13,
13,
13,
30,
30,
30,
13,
16,
13,
16,
13,
16,
21,
21,
21,
29,
29,
29,
10,
10,
10,
31,
31,
31,

06,
06,
06,
06,
06,
06,
06,
06,
06,
18,
18,
18,
12,
12,
12,
30,
30,
30,
06,
06,
06,
30,
30,
30,
24,
24,

2010

2010

2010

2006

2006

2006

2007

2007

2007

1987

2006

1987

2006

1987

2006

1987

1987

1987

2001

2001

2001

2006

2006

2006

1991

1991

1991

2010

2010

2010

2010

2010

2010

2010

2010

2010

2012

2012

2012

2015

2015

2015

2013

2013

2013

2010

2010

2010

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-236(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LOSARTAN POTASSIUM

TABLET;ORAL

LOSARTAN POTASSIUM

AB
AB
MYLAN
AB
AB
AB
PRINSTON INC
AB
AB
AB
ROXANE
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
UNICHEM LABS LTD
AB
AB
AB
UPSHER SMITH
AB
AB
AB
VIVIMED LABS
AB
AB
AB
WATSON LABS
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
LOTEPREDNOL ETABONATE

GEL;OPHTHALMIC

LOTEMAX

+ BAUSCH AND LOMB INC
OINTMENT;OPHTHALMIC

LOTEMAX

+ BAUSCH AND LOMB
SUSPENSION/DROPS;OPHTHALMIC

ALREX

+ BAUSCH AND LOMB
LOTEMAX

+ BAUSCH AND LOMB

100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A091541
A091590
A091590
A091590
A091497
A091497
A091497
A077459
A077459
A077459
A077424
A077424
A077424
A076958
A076958
A076958
A090467
A090467
A090467
A203030
A203030
A203030
A090544
A090544
A090544
A090382
A090382
A090382
A091129
A091129
A091129
A078243
A078243
A078243

003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

0.5%

N202872 001 Sep 28, 2012

0.5%

N200738 001 Apr 15, 2011

0.2%

N020803 001 Mar 09, 1998

0.5%

N020583 001 Mar 09, 1998

Sep
Oct
Oct
Oct
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

24,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
14,
14,
14,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,

2012

2010

2010

2010

2011

2011

2011

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2015

2015

2015

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

LOTEPREDNOL ETABONATE; TOBRAMYCIN

SUSPENSION/DROPS;OPHTHALMIC

ZYLET

+ BAUSCH AND LOMB
0.5%;0.3%

N050804 001 Dec 14, 2004

LOVASTATIN

TABLET;ORAL

LOVASTATIN

AB
ACTAVIS ELIZABETH
AB
AB
AB
APOTEX INC
AB
AB
AB
CARLSBAD
AB
AB
+
AB
LUPIN
AB
AB
AB
MUTUAL PHARM
AB
AB

A075828
A075828
A075828
A077748
A077748
A077748
A075991
A075991
A075991
A078296
A078296
A078296
A077520
A077520
A077520

10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Dec
Dec
Dec
Feb
Feb
Feb
Jun
Jun
Jun
Mar
Nov
Nov
Apr
Apr
Apr

17,
17,
17,
28,
28,
28,
05,
05,
05,
14,
01,
01,
14,
14,
14,

2001

2001

2001

2007

2007

2007

2002

2002

2002

2008

2007

2007

2006

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-237(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LOVASTATIN

TABLET;ORAL

LOVASTATIN

AB
MYLAN
10MG
AB
10MG
AB
20MG
AB
20MG
AB
40MG
AB
40MG
AB
SANDOZ
10MG
AB
10MG
AB
20MG
AB
20MG
AB
40MG
AB
40MG
AB
TEVA
10MG
AB
20MG
AB
40MG
TABLET, EXTENDED RELEASE;ORAL

ALTOPREV

COVIS PHARMA SARL
20MG
40MG
+
60MG

A075451
A075935
A075451
A075935
A075451
A075935
A075300
A075636
A075300
A075636
A075300
A075636
A075551
A075551
A075551

001
001
002
002
003
003
001
001
002
002
003
003
003
002
001

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,

2001

2001

2001

2001

2001

2001

2001

2001

2001

2001

2001

2001

2001

2001

2001

N021316 002 Jun 26, 2002

N021316 003 Jun 26, 2002

N021316 004 Jun 26, 2002

LOVASTATIN; NIACIN

TABLET, EXTENDED RELEASE;ORAL

ADVICOR

+ ABBVIE
20MG;500MG
+
20MG;750MG
+
20MG;1GM
+
40MG;1GM

N021249
N021249
N021249
N021249

LOXAPINE

POWDER;INHALATION

ADASUVE

+ TEVA PHARMS USA INC

10MG

N022549 001 Dec 21, 2012

LOXAPINE SUCCINATE

CAPSULE;ORAL

LOXAPINE SUCCINATE

AB
ELITE LABS INC
AB
AB
AB
AB
LANNETT HOLDINGS INC
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
WATSON LABS
AB
AB
+
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A076868
A076868
A076868
A076868
A090695
A090695
A090695
A090695
A076762
A076762
A076762
A076762
A072204
A072205
A072206
A072062

LUBIPROSTONE

CAPSULE;ORAL

AMITIZA

SUCAMPO PHARMA LLC
+

8MCG
24MCG

N021908 002 Apr 29, 2008

N021908 001 Jan 31, 2006

LULICONAZOLE

CREAM;TOPICAL

LUZU

+ MEDICIS

1%

N204153 001 Nov 14, 2013

20MG
40MG
60MG
80MG

N200603
N200603
N200603
N200603

LURASIDONE HYDROCHLORIDE

TABLET;ORAL

LATUDA

SUNOVION PHARMS INC
+

5MG BASE
10MG BASE
25MG BASE
50MG BASE
5MG BASE
10MG BASE
25MG BASE
50MG BASE
5MG BASE
10MG BASE
25MG BASE
50MG BASE
5MG BASE
10MG BASE
25MG BASE
50MG BASE

001
002
003
004

001
002
003
004
001
002
003
004
001
002
003
004
001
001
001
001

003
001
005
002

Dec
Dec
Dec
Apr

Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Nov
Nov
Nov
Nov
Jun
Jun
Jun
Jun

Dec
Oct
Jul
Oct

17,
17,
17,
27,

04,
04,
04,
04,
26,
26,
26,
26,
01,
01,
01,
01,
15,
15,
15,
15,

07,
28,
12,
28,

2001

2001

2001

2006

2005

2005

2005

2005

2011

2011

2011

2011

2004

2004

2004

2004

1988

1988

1988

1988

2011

2010

2013

2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-238(of 388)

PRESCRIPTION DRUG PRODUCT LIST

LURASIDONE HYDROCHLORIDE

TABLET;ORAL

LATUDA

MACITENTAN

TABLET;ORAL

OPSUMIT

+ ACTELION PHARMS LTD

MAFENIDE ACETATE

CREAM;TOPICAL

SULFAMYLON

+ MYLAN INSTITUTIONAL

FOR SOLUTION;TOPICAL

MAFENIDE ACETATE
AT
PAR FORM
SULFAMYLON
AT
+ MYLAN INSTITUTIONAL

120MG

N200603 004 Apr 26, 2012

10MG

N204410 001 Oct 18, 2013

EQ 85MG BASE/GM

N016763 001

5%

A201511 001 Feb 12, 2013

5%

N019832 003 Jun 05, 1998

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

INJECTABLE;INJECTION

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER

+ B BRAUN
30MG/100ML;37MG/100ML;0.82MG/100ML;370M
N019696 001 Sep 29, 1989

G/100ML;530MG/100ML;500MG/100ML;12MG/10

0ML

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

INJECTABLE;INJECTION

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
30MG/100ML;37MG/100ML;368MG/100ML;526MG

N017378 001

/100ML;502MG/100ML

PLASMA-LYTE A IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
30MG/100ML;37MG/100ML;368MG/100ML;526MG

N017378 002 Nov

/100ML;502MG/100ML

ISOLYTE S IN PLASTIC CONTAINER

B BRAUN
30MG/100ML;37MG/100ML;370MG/100ML;530MG

N019711 001 Sep

/100ML;500MG/100ML

NORMOSOL-R IN PLASTIC CONTAINER

HOSPIRA
30MG/100ML;37MG/100ML;222MG/100ML;526MG

N017586 001

/100ML;502MG/100ML

SOLUTION;IRRIGATION

PHYSIOLYTE IN PLASTIC CONTAINER

B BRAUN
30MG/100ML;37MG/100ML;370MG/100ML;530MG

N019024 001 Jun

/100ML;500MG/100ML

PHYSIOSOL IN PLASTIC CONTAINER

HOSPIRA
30MG/100ML;37MG/100ML;222MG/100ML;526MG

N017637 002 Jul

/100ML;502MG/100ML

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

SOLUTION;INJECTION

NORMOCARB HF 25

+ DIALYSIS SUPS
0.21GM/100ML;2.8GM/100ML;9.07GM/100ML

NORMOCARB HF 35

+ DIALYSIS SUPS
0.21GM/100ML;3.97GM/100ML;8.3GM/100ML

MAGNESIUM SULFATE

INJECTABLE;INJECTION

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

+ HOSPIRA
1GM/100ML

+
2GM/100ML

MAGNESIUM SULFATE IN PLASTIC CONTAINER

HOSPIRA
2GM/50ML (40MG/ML)

+
4GM/100ML (40MG/ML)

+
4GM/50ML (80MG/ML)

20GM/500ML (40MG/ML)

40GM/1000ML(40MG/ML)

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

MAGNESIUM SULFATE

AP
EXELA PHARMA SCS LLC
5GM/10ML (500MG/ML)
AP
+ FRESENIUS KABI USA
5GM/10ML (500MG/ML)
AP
+ HOSPIRA
5GM/10ML (500MG/ML)
HOSPIRA INC
10GM/20ML (500MG/ML)

22, 1982

29, 1989

08, 1984

08, 1982

N021910 001 Jul 26, 2006

N021910 002 Jul 26, 2006

N020488 001 Jul 11, 1995

N020488 002 Jul 11, 1995

N020309
N020309
N020309
N020309
N020309

003
001
002
004
005

Jan
Jun
Jun
Jan
Jan

26,
24,
24,
18,
18,

2007

1994

1994

1995

1995

A206039
N019316
A075151
A202411

001
001
001
001

Dec
Sep
Apr
May

18,
08,
25,
14,

2014

1986

2000

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-239(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MAGNESIUM SULFATE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

MAGNESIUM SULFATE

+ FRESENIUS KABI USA
1GM/2ML (500MG/ML)

N019316 002 Sep 08, 1986

MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE

SOLUTION;ORAL

SUPREP BOWEL PREP KIT

+ BRAINTREE LABS
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

N022372 001 Aug 05, 2010

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM

PHOSPHATE

SOLUTION;IRRIGATION

TIS-U-SOL

AT
BAXTER HLTHCARE
20MG/100ML;40MG/100ML;6.25MG/100ML;800M
N018508 001 Feb 19, 1982

G/100ML;8.75MG/100ML

TIS-U-SOL IN PLASTIC CONTAINER

AT
BAXTER HLTHCARE
20MG/100ML;40MG/100ML;6.25MG/100ML;800M
N018336 001

G/100ML;8.75MG/100ML

MALATHION

LOTION;TOPICAL

MALATHION
AT
SUVEN LIFE
OVIDE
AT
+ TARO PHARMS NORTH

0.5%

A091559 001 May 23, 2012

0.5%

N018613 001 Aug 02, 1982

MANGANESE CHLORIDE

INJECTABLE;INJECTION

MANGANESE CHLORIDE IN PLASTIC CONTAINER

HOSPIRA
EQ 0.1MG MANGANESE/ML
MANNITOL

INJECTABLE;INJECTION

MANNITOL 10% IN PLASTIC CONTAINER

AP
B BRAUN
10GM/100ML
AP
HOSPIRA
10GM/100ML
MANNITOL 15% IN PLASTIC CONTAINER

AP
B BRAUN
15GM/100ML
AP
HOSPIRA
15GM/100ML
MANNITOL 20% IN PLASTIC CONTAINER

AP
B BRAUN
20GM/100ML
AP
HOSPIRA
20GM/100ML
MANNITOL 25%

AP
FRESENIUS KABI USA
12.5GM/50ML
AP
HOSPIRA
12.5GM/50ML
AP
INTL MEDICATION
12.5GM/50ML
AP
LUITPOLD
12.5GM/50ML
MANNITOL 5% IN PLASTIC CONTAINER

AP
B BRAUN
5GM/100ML
AP
HOSPIRA
5GM/100ML
OSMITROL 10% IN WATER

AP
BAXTER HLTHCARE
10GM/100ML
OSMITROL 10% IN WATER IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
10GM/100ML
OSMITROL 15% IN WATER

AP
BAXTER HLTHCARE
15GM/100ML
OSMITROL 15% IN WATER IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
15GM/100ML
OSMITROL 20% IN WATER

AP
BAXTER HLTHCARE
20GM/100ML
OSMITROL 20% IN WATER IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
20GM/100ML
OSMITROL 5% IN WATER

AP
BAXTER HLTHCARE
5GM/100ML
OSMITROL 5% IN WATER IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
5GM/100ML
SOLUTION;IRRIGATION

RESECTISOL IN PLASTIC CONTAINER

B BRAUN
5GM/100ML

N018962 001 Jun 26, 1986

N020006 002 Jul 26, 1993

N019603 002 Jan 08, 1987

N020006 003 Jul 26, 1993

N019603 003 Jan 08, 1990

N020006 004 Jul 26, 1993

N019603 004 Jan 08, 1990

A080677
N016269
A083051
A087409

001

006 Aug 25, 1994

001

001 Jan 21, 1982

N020006 001 Jul 26, 1993

N019603 001 Jan 08, 1987

N013684 002

N013684 006

N013684 004

N013684 008

N013684 003

N013684 007

N013684 001

N013684 005

N016772 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-240(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MANNITOL; SORBITOL

SOLUTION;IRRIGATION

SORBITOL-MANNITOL IN PLASTIC CONTAINER

HOSPIRA
540MG/100ML;2.7GM/100ML
MAPROTILINE HYDROCHLORIDE

TABLET;ORAL

MAPROTILINE HYDROCHLORIDE

MYLAN
+

N018316 001

25MG
50MG
75MG

A072285 002 Oct 03, 1988

A072285 001 Oct 03, 1988

A072285 003 Oct 03, 1988

MARAVIROC

TABLET;ORAL

SELZENTRY

VIIV HLTHCARE
+

150MG
300MG

N022128 001 Aug 06, 2007

N022128 002 Aug 06, 2007

MEBENDAZOLE

TABLET, CHEWABLE;ORAL

MEBENDAZOLE

+ AMEDRA PHARMS LLC

100MG

A073580 001 Jan 04, 1995

MECAMYLAMINE HYDROCHLORIDE

TABLET;ORAL

MECAMYLAMINE HYDROCHLORIDE

NEXGEN PHARMA
2.5MG

A204054 001 Mar 19, 2013

MECASERMIN RECOMBINANT

INJECTABLE;SUBCUTANEOUS

INCRELEX

+ IPSEN INC

40MG/4ML (10MG/ML)

N021839 001 Aug 30, 2005

MECHLORETHAMINE HYDROCHLORIDE

GEL;TOPICAL

VALCHLOR

+ ACTELION PHARMS LTD
INJECTABLE;INJECTION

MUSTARGEN

+ RECORDATI RARE

EQ 0.016% BASE

N202317 001 Aug 23, 2013

10MG/VIAL

N006695 001

MECLIZINE HYDROCHLORIDE

TABLET;ORAL

MECLIZINE HYDROCHLORIDE

AA
AMNEAL PHARMS
AA
AA
EPIC PHARMA LLC
AA
AA
JUBILANT CADISTA
AA
AA
MYLAN PHARMS INC
AA
AA
PAR PHARM
AA
AA
SANDOZ
AA

12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG

A201451
A201451
A200294
A200294
A040659
A040659
A202640
A202640
A087127
A087128
A084843
A084092

MECLOFENAMATE SODIUM

CAPSULE;ORAL

MECLOFENAMATE SODIUM

MYLAN
+

EQ 50MG BASE
EQ 100MG BASE

A071081 002 Sep 03, 1986

A071081 001 Sep 03, 1986

MEDROXYPROGESTERONE ACETATE

INJECTABLE;INJECTION

DEPO-PROVERA

AB
+ PHARMACIA AND UPJOHN
150MG/ML
MEDROXYPROGESTERONE ACETATE

AB
SANDOZ
150MG/ML
AB
TEVA PHARMS USA
150MG/ML
DEPO-PROVERA

+ PHARMACIA AND UPJOHN 400MG/ML
INJECTABLE;SUBCUTANEOUS

DEPO-SUBQ PROVERA 104

+ PHARMACIA AND UPJOHN
104MG/0.65ML

001
002
001
002
001
002
001
002
001

001

002
003

Feb
Feb
Apr
Apr
Jun
Jun
Sep
Sep

23,
23,
13,
13,
04,
04,
17,
17,

2011

2011

2012

2012

2010

2010

2012

2012

May 22, 1989

May 22, 1989

N020246 001 Oct 29, 1992

A078711 001 May 20, 2009

A076553 001 Jul 28, 2004

N012541 003

N021583 001 Dec 17, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-241(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MEDROXYPROGESTERONE ACETATE

TABLET;ORAL

MEDROXYPROGESTERONE ACETATE

AB
BARR
2.5MG
AB
5MG
AB
10MG
PROVERA

AB
PHARMACIA AND UPJOHN
2.5MG
AB
5MG
AB
+
10MG

A040159 001 Aug 09, 1996

A040159 002 Aug 09, 1996

A040159 003 Aug 09, 1996

N011839 001

N011839 003

N011839 004

MEFENAMIC ACID

CAPSULE;ORAL

MEFENAMIC ACID

AB
BRECKENRIDGE PHARM
AB
LUPIN LTD
AB
MICRO LABS LTD
AB
VINTAGE PHARMS LLC
PONSTEL

AB
+ SHIONOGI INC

250MG
250MG
250MG
250MG

A090359
A091322
A090562
A091608

250MG

N015034 003

MEFLOQUINE HYDROCHLORIDE

TABLET;ORAL

MEFLOQUINE HYDROCHLORIDE

AB
BARR
AB
ROXANE
AB
+ SANDOZ

250MG
250MG
250MG

A076392 001 Dec 29, 2003

A076523 001 Oct 01, 2004

A076175 001 Feb 20, 2002

40MG/ML

N020264 001 Sep 10, 1993

125MG/ML

N021778 001 Jul 05, 2005

40MG/ML
40MG/ML
40MG/ML
125MG/ML
40MG/ML

A075671
A075997
A075681
A203139
A076721

001
001
001
001
001

Jul
Feb
May
Aug
Nov

25,
15,
05,
27,
01,

2001

2002

2003

2014

2004

20MG
40MG
20MG
40MG
20MG
40MG

A074621
A074621
A072422
A072423
A074458
A074458

002
001
001
001
001
002

Aug
Nov
Aug
Aug
Sep
Sep

16,
30,
08,
08,
29,
29,

1996

1995

1988

1988

1995

1995

5MG
10MG

N207233 001 Oct 22, 2015

N207233 002 Oct 22, 2015

7.5MG/5ML

N021530 001 Jun 01, 2004

7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG

A077882
A077882
A078008
A078008
A077920
A077920
A077918
A077918
A077929
A077929
A077931
A077931
A077932
A077932
A077944

MEGESTROL ACETATE

SUSPENSION;ORAL

MEGACE

AB
+ BRISTOL MYERS SQUIBB
MEGACE ES

AB
+ PAR PHARM
MEGESTROL ACETATE

AB
PAR PHARM
AB
ROXANE
AB
TEVA PHARMS
AB
TWI PHARMS INC
AB
WOCKHARDT
TABLET;ORAL

MEGESTROL ACETATE

AB
BARR
AB
AB
PAR PHARM
AB
+
AB
ROXANE
AB
MELOXICAM

CAPSULE;ORAL

VIVLODEX

IROKO PHARMS LLC
+
SUSPENSION;ORAL

MOBIC

+ BOEHRINGER INGELHEIM
TABLET;ORAL

MELOXICAM

AB
APOTEX INC
AB
AB
AUROBINDO PHARMA
AB
AB
BRECKENRIDGE PHARM
AB
AB
CARLSBAD
AB
AB
CIPLA LTD
AB
AB
DR REDDYS LABS INC
AB
AB
GLENMARK GENERICS
AB
AB
LUPIN PHARMS

001
001
001
001

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001

Feb
Jul
Nov
Jun

Jul
Jul
Oct
Oct
Jul
Jul
Dec
Dec
Jul
Jul
Jul
Jul
Jul
Jul
Jul

05,
22,
19,
02,

20,
20,
02,
02,
19,
19,
07,
07,
19,
19,
25,
25,
19,
19,
19,

2013

2011

2010

2014

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-242(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MELOXICAM

TABLET;ORAL

MELOXICAM
AB
AB
MYLAN
AB
AB
PURACAP PHARM
AB
AB
STRIDES PHARMA
AB
AB
SUN PHARM INDS INC
AB
AB
TARO
AB
AB
TEVA PHARMS
AB
AB
UNICHEM
AB
AB
ZYDUS PHARMS USA
AB
MOBIC
AB
BOEHRINGER INGELHEIM
AB
+
MELPHALAN

TABLET;ORAL

ALKERAN

+ GLAXOSMITHKLINE

MELPHALAN HYDROCHLORIDE

INJECTABLE;INJECTION

ALKERAN

AP
+ GLAXOSMITHKLINE

MELPHALAN HYDROCHLORIDE

AP
EUROHLTH INTL SARL

AP
MYLAN INSTITUTIONAL

15MG

7.5MG

15MG

7.5MG

15MG

7.5MG

15MG

7.5MG

15MG

7.5MG

15MG

7.5MG

15MG

7.5MG

15MG

7.5MG

15MG

A077944
A077923
A077923
A077938
A077938
A077928
A077928
A077937
A077937
A078102
A078102
A077936
A077936
A077927
A077927
A077921
A077921

7.5MG

15MG

N020938 001 Apr 13, 2000

N020938 002 Aug 23, 2000

2MG

N014691 002

EQ 50MG BASE/VIAL

N020207 001 Nov 18, 1992

EQ 50MG BASE/VIAL

EQ 50MG BASE/VIAL

A090303 001 Oct 28, 2010

A090270 001 Jun 09, 2009

MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

NAMENDA XR

FOREST LABS LLC

7MG

14MG

21MG

+

28MG

SOLUTION;ORAL

MEMANTINE HYDROCHLORIDE
AA
BIO-PHARM INC
2MG/ML

AA
MACLEODS PHARMS LTD
2MG/ML

AA
SILARX PHARMS INC
2MG/ML

NAMENDA
AA
+ FOREST LABS LLC
2MG/ML

TABLET;ORAL

MEMANTINE HYDROCHLORIDE

AB
AJANTA PHARMA LTD

5MG

AB

10MG

AB
ALEMBIC PHARMS LTD

5MG

AB

10MG

AB
AMNEAL PHARMS

5MG

AB

10MG

AB
AUROBINDO PHARMA LTD
5MG

AB

10MG

AB
DR REDDYS LABS LTD

5MG

AB

10MG

AB
JUBILANT GENERICS

5MG

AB

10MG

AB
LUPIN LTD

5MG

AB

10MG

AB
MACLEODS PHARMS LTD

5MG

AB

10MG

AB
MYLAN PHARMS INC

5MG

AB

10MG

AB
PURACAP PHARM LLC

5MG

AB

10MG

AB
SUN PHARMA GLOBAL

5MG

N022525
N022525
N022525
N022525

002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

001
002
003
004

Jul
Jul
Jul
Jul
Jul
May
May
Jul
Jul
Nov
Nov
Jul
Jul
Dec
Dec
Jul
Jul

Jun
Jun
Jun
Jun

19,
19,
19,
19,
19,
13,
13,
19,
19,
07,
07,
19,
19,
20,
20,
19,
19,

21,
21,
21,
21,

2006

2006

2006

2006

2006

2009

2009

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2010

2010

2010

2010

A205446 001 Dec 07, 2015

A202790 001 Oct 13, 2015

A204033 001 Oct 13, 2015

N021627 001 Apr 18, 2005

A206528
A206528
A200891
A200891
A090041
A090041
A203175
A203175
A090048
A090048
A091585
A091585
A090051
A090051
A202840
A202840
A079225
A079225
A206855
A206855
A090058

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001

Nov
Nov
Oct
Oct
Apr
Apr
Oct
Oct
Apr
Apr
Oct
Oct
Apr
Apr
Oct
Oct
Jan
Jan
Nov
Nov
May

30,
30,
13,
13,
10,
10,
13,
13,
14,
14,
13,
13,
10,
10,
13,
13,
30,
30,
17,
17,
05,

2015

2015

2015

2015

2015

2015

2015

2015

2010

2010

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-243(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MEMANTINE HYDROCHLORIDE

TABLET;ORAL

MEMANTINE HYDROCHLORIDE

AB
AB
TEVA PHARMS
AB
AB
TORRENT PHARMS LTD
AB
AB
UNICHEM LABS LTD
AB
AB
UPSHER SMITH
AB
AB
WOCKHARDT LTD
AB
NAMENDA

AB
FOREST LABS LLC
AB
+

10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A090058
A090052
A090052
A200155
A200155
A200022
A200022
A090043
A090043
A090073
A090073

5MG
10MG

N021487 001 Oct 16, 2003

N021487 002 Oct 16, 2003

MENOTROPINS (FSH;LH)

INJECTABLE;SUBCUTANEOUS

MENOPUR

+ FERRING

75 IU/VIAL;75 IU/VIAL

N021663 001 Oct 29, 2004

MEPENZOLATE BROMIDE

TABLET;ORAL

CANTIL

+ SANOFI AVENTIS US

25MG

N010679 003

MEPERIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

DEMEROL

AP
+ HOSPIRA
25MG/ML
AP
+
50MG/ML
AP
+
75MG/ML
AP
+
100MG/ML
MEPERIDINE HYDROCHLORIDE

AP
EUROHLTH INTL SARL
25MG/ML
AP
50MG/ML
AP
75MG/ML
AP
100MG/ML
AP
HIKMA MAPLE
25MG/ML
AP
50MG/ML
AP
75MG/ML
AP
100MG/ML
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

AP
HIKMA MAPLE
10MG/ML
AP
+ HOSPIRA
10MG/ML
SYRUP;ORAL

MEPERIDINE HYDROCHLORIDE

+ ROXANE
50MG/5ML
TABLET;ORAL

DEMEROL

AA
+ SANOFI AVENTIS US
50MG
AA
+
100MG
MEPERIDINE HYDROCHLORIDE

AA
BARR
50MG
AA
100MG
AA
EPIC PHARMA
50MG
AA
100MG
AA
MALLINCKRODT
50MG
AA
100MG
AA
MIKART
50MG
AA
100MG
AA
ROXANE
50MG
AA
100MG
AA
SUN PHARM INDS INC
50MG
AA
100MG
AA
VINTAGE PHARMS
50MG
AA
100MG
MIKART
75MG
150MG

002
001
002
001
002
001
002
001
002
001
002

N021171
N021171
N021171
N021171

001

002

003

004

A080445
A080445
A080445
A080445
A080455
A080455
A080455
A080455

001

002

003

004

007

008

009

010

May
Oct
Oct
Oct
Oct
Oct
Oct
Jul
Jul
Sep
Sep

05,
25,
25,
13,
13,
13,
13,
31,
31,
04,
04,

2010

2011

2011

2015

2015

2015

2015

2015

2015

2015

2015

A081002 001 Jul 30, 1993

A088432 001 Aug 16, 1984

A088744 001 Jan 30, 1985

N005010 001

N005010 004

A088639
A088640
A040331
A040331
A040352
A040352
A040893
A040893
A040110
A040110
A040446
A040446
A040191
A040191
A040893
A040893

001
001
001
002
001
002
001
003
001
002
001
002
001
002
002
004

Jul
Sep
May
May
Jun
Jun
Jun
Jun
Mar
Mar
Aug
Aug
Dec
Dec
Jun
Jun

02,
19,
28,
28,
13,
13,
24,
24,
12,
12,
08,
08,
17,
17,
24,
24,

1984

1984

1999

1999

2000

2000

2009

2009

1997

1997

2002

2002

1998

1998

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-244(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CARBOCAINE

AP
+ HOSPIRA
AP
+
AP
+
ISOCAINE HYDROCHLORIDE

AP
+ NOVOCOL
MEPIVACAINE HYDROCHLORIDE

AP
HOSPIRA INC
POLOCAINE

AP
FRESENIUS KABI USA
AP
POLOCAINE-MPF

AP
FRESENIUS KABI USA
AP
AP
SCANDONEST PLAIN

AP
+ DEPROCO
MEPROBAMATE

TABLET;ORAL

MEPROBAMATE

AA
ALEMBIC PHARMS LTD
AA
AA
INVAGEN PHARMS
AA
AA
+ WATSON LABS
AA
+
MERCAPTOPURINE

SUSPENSION;ORAL

PURIXAN

+ NOVA LABS LTD
TABLET;ORAL

MERCAPTOPURINE

AB
MYLAN
AB
PROMETHEUS LABS
AB
+ ROXANE

1%
1.5%
2%

N012250 001

N012250 005

N012250 002

3%

A080925 001

3%

A040806 001 Apr 28, 2008

1%
2%

A089407 001 Dec 01, 1986

A089410 001 Dec 01, 1986

1%
1.5%
2%

A089406 001 Dec 01, 1986

A089408 001 Dec 01, 1986

A089409 001 Dec 01, 1986

3%

A088387 001 Oct 10, 1984

200MG
400MG
200MG
400MG
200MG
400MG

A090122
A090122
A040797
A040797
A083304
A083308

20MG/ML

N205919 001 Apr 28, 2014

50MG
50MG
50MG

A040594 001 Jul 01, 2005

A040461 001 Feb 11, 2004

A040528 001 Feb 13, 2004

MEROPENEM

INJECTABLE;INJECTION

MEROPENEM

AP
ACS DOBFAR
500MG/VIAL
AP
1GM/VIAL
AP
DAEWOONG PHARM CO
500MG/VIAL
AP
1GM/VIAL
AP
HOSPIRA INC
500MG/VIAL
AP
1GM/VIAL
AP
SANDOZ
500MG/VIAL
AP
1GM/VIAL
MERREM

AP
+ ASTRAZENECA
500MG/VIAL
AP
+
1GM/VIAL
POWDER;IV (INFUSION)

MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER

B BRAUN MEDICAL INC
500MG/VIAL
1GM/VIAL
MESALAMINE

CAPSULE, DELAYED RELEASE;ORAL

DELZICOL

+ WARNER CHILCOTT LLC
400MG
CAPSULE, EXTENDED RELEASE;ORAL

APRISO

+ VALEANT PHARMS INTL
375MG
PENTASA

SHIRE
250MG
+
500MG
ENEMA;RECTAL

MESALAMINE

AB
G AND W LABS INC
4GM/60ML
AB
PERRIGO ISRAEL
4GM/60ML

A091404
A091404
A204854
A204854
A090940
A090940
A091201
A091201

001
002
001
002
001

001

001
002
001
002
001
002
001
002

Feb
Feb
Feb
Feb

Oct
Oct
Dec
Dec
Jun
Jun
Mar
Mar

18,
18,
27,
27,

26,
26,
18,
18,
22,
22,
29,
29,

2009

2009

2008

2008

2011

2011

2015

2015

2010

2010

2011

2011

N050706 003 Jun 21, 1996

N050706 001 Jun 21, 1996

N202106 001 Apr 30, 2015

N202106 002 Apr 30, 2015

N204412 001 Feb 01, 2013

N022301 001 Oct 31, 2008

N020049 001 May 10, 1993

N020049 002 Jul 08, 2004

A076841 001 Sep 30, 2004

A076751 001 Sep 17, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-245(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MESALAMINE

ENEMA;RECTAL

ROWASA

AB
+ MEDA PHARMS
SFROWASA

AB
MEDA PHARMS
SUPPOSITORY;RECTAL

CANASA

AB
+ FOREST LABS LLC
MESALAMINE

AB
MYLAN PHARMS INC
TABLET, DELAYED RELEASE;ORAL

ASACOL HD

+ WARNER CHILCOTT LLC
LIALDA

+ SHIRE
MESNA

INJECTABLE;INTRAVENOUS

MESNA

AP
EUROHLTH INTL SARL
AP
FRESENIUS KABI USA
AP
MYLAN INSTITUTIONAL
AP
MYLAN LABS LTD
AP
SAGENT PHARMS
AP
TEVA PHARMS USA
MESNEX

AP
+ BAXTER HLTHCARE
TABLET;ORAL

MESNEX

+ BAXTER HLTHCARE
MESTRANOL; NORETHINDRONE

TABLET;ORAL-28

NORINYL 1+50 28-DAY

+ ACTAVIS LABS UT INC

4GM/60ML

N019618 001 Dec 24, 1987

4GM/60ML

N019618 002 Jun 20, 2008

1GM

N021252 002 Nov 05, 2004

1GM

A204354 001 Nov 24, 2015

800MG

N021830 001 May 29, 2008

1.2GM

N022000 001 Jan 16, 2007

100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML

A075739
A075811
A076488
A203364
A090913
A075764

100MG/ML

N019884 001 Dec 30, 1988

400MG

N020855 001 Mar 21, 2002

0.05MG;1MG

N016659 001

001
001
001
001
001
001

Jan
Apr
Mar
Jul
Apr
Apr

09,
26,
08,
18,
13,
27,

2004

2001

2012

2014

2010

2001

METAPROTERENOL SULFATE

SYRUP;ORAL

METAPROTERENOL SULFATE

+ SILARX
TABLET;ORAL

METAPROTERENOL SULFATE

PAR PHARM
+

10MG/5ML

A073632 001 Jul 22, 1992

10MG
20MG

A072024 001 Jun 28, 1988

A072025 001 Jun 28, 1988

METARAMINOL BITARTRATE

INJECTABLE;INJECTION

METARAMINOL BITARTRATE

+ FRESENIUS KABI USA

EQ 10MG BASE/ML

A080722 001

800MG
800MG

A203399 001 Jun 21, 2013

A040445 001 Mar 31, 2010

800MG

N013217 003 Aug 30, 2002

400MG

A040486 001 Feb 27, 2015

500MG/5ML

N021591 001 Sep 11, 2003

500MG
850MG
1GM

N020357 001 Mar 03, 1995

N020357 002 Mar 03, 1995

N020357 005 Nov 05, 1998

500MG
850MG
1GM
500MG

A091184
A091184
A091184
A077880

METAXALONE

TABLET;ORAL

METAXALONE

AB
AMNEAL PHARMS
AB
SANDOZ
SKELAXIN

AB
+ KING PHARMS
METAXALONE

COREPHARMA
METFORMIN HYDROCHLORIDE

SOLUTION;ORAL

RIOMET

+ SUN PHARM INDS LTD
TABLET;ORAL

GLUCOPHAGE

AB
BRISTOL MYERS SQUIBB
AB
AB
+
METFORMIN HYDROCHLORIDE

AB
ALKEM
AB
AB
AB
AMNEAL PHARMS NY

001
002
003
001

Nov
Nov
Nov
Jun

01,
01,
01,
05,

2010

2010

2010

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-246(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METFORMIN HYDROCHLORIDE

TABLET;ORAL

METFORMIN HYDROCHLORIDE

AB
AB
AB
APOTEX
AB
AB
AB
AB
AB
AB
ATLAS PHARMS LLC
AB
AB
AB
AUROBINDO
AB
AB
AB
CHARTWELL LIFE SCI
AB
AB
AB
DR REDDYS LABS INC
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
GRANULES INDIA
AB
AB
AB
INDICUS PHARMA
AB
AB
AB
MARKSANS PHARMA
AB
AB
AB
MUTUAL PHARMA
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
PROVIDENT PHARM
AB
AB
AB
SANDOZ
AB
AB
AB
AB
AB
AB
SCIEGEN PHARMS INC
AB
AB
AB
SUN PHARM INDS INC
AB
AB
AB
TEVA
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
WATSON LABS FLORIDA
AB
AB
AB
ZYDUS HLTHCARE

850MG
1GM
500MG
500MG
850MG
850MG
1GM
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
500MG
850MG
850MG
1GM
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
500MG
850MG
850MG
1GM
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG

A077880
A077880
A075984
A090666
A075984
A090666
A075984
A090666
A076033
A076033
A076033
A077095
A077095
A077095
A075972
A075972
A075972
A077787
A077787
A077787
A078170
A078170
A078170
A090564
A090564
A090564
A079148
A079148
A079148
A090888
A090888
A090888
A076038
A076038
A076038
A075973
A075976
A075973
A075976
A075973
A075976
A075969
A075969
A075969
A077853
A077853
A077853
A075965
A075985
A075965
A075985
A075965
A075985
A203769
A203769
A203769
A075967
A075967
A075967
A075978
A075978
A075978
A077711
A077711
A077711
A075961
A075961
A075961
A203686

002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001

Jun
Jun
Apr
Dec
Apr
Dec
Apr
Dec
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Aug
Aug
Aug
May
May
May
Apr
Apr
Apr
Nov
Nov
Nov
Mar
Mar
Mar
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jul
Jul
Jul
Jan
Jan
Jan
Jan
Jan
Jan
Sep
Sep
Sep
Jan
Jan
Jan
Jan
Jan
Nov
Jan
Jan
Jan
Jan
Jan
Jan
Aug

05,
05,
23,
07,
23,
07,
23,
07,
24,
24,
24,
14,
14,
14,
24,
24,
24,
23,
23,
23,
23,
23,
23,
22,
22,
22,
25,
25,
25,
12,
12,
12,
21,
21,
21,
25,
24,
25,
24,
25,
24,
29,
29,
29,
28,
28,
28,
25,
25,
25,
25,
25,
25,
11,
11,
11,
29,
29,
29,
25,
25,
05,
24,
24,
24,
25,
25,
25,
28,

2006

2006

2002

2011

2002

2011

2002

2011

2002

2002

2002

2005

2005

2005

2002

2002

2002

2006

2006

2006

2008

2008

2008

2010

2010

2010

2008

2008

2008

2012

2012

2012

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2006

2006

2006

2002

2002

2002

2002

2002

2002

2013

2013

2013

2002

2002

2002

2002

2002

2002

2007

2007

2007

2002

2002

2002

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-247(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METFORMIN HYDROCHLORIDE

TABLET;ORAL

METFORMIN HYDROCHLORIDE
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
CHARTWELL LIFE SCI

850MG

1GM

500MG

850MG

1GM

625MG

750MG

TABLET, EXTENDED RELEASE;ORAL

GLUCOPHAGE XR

AB
+ BRISTOL MYERS SQUIBB
750MG

METFORMIN HYDROCHLORIDE

AB
ACTAVIS LABS FL INC

750MG

AB
AMNEAL PHARMS NY

750MG

AB
APOTEX

750MG

AB
AUROBINDO PHARMA LTD
750MG

AB
BARR

750MG

AB
CSPC OUYI PHARM CO

750MG

AB
IMPAX LABS

750MG

AB
MYLAN

750MG

AB
NOSTRUM PHARMS LLC

750MG

AB
SUN PHARM INDS (IN)

750MG

AB
TEVA

750MG

AB
ZYDUS PHARMS USA

750MG

GLUCOPHAGE XR

AB1
BRISTOL MYERS SQUIBB
500MG

METFORMIN HYDROCHLORIDE

AB1
ACTAVIS LABS FL INC

500MG

AB1
AMNEAL PHARMS NY

500MG

AB1
APOTEX

500MG

AB1
AUROBINDO PHARMA LTD
500MG

AB1
CSPC OUYI PHARM CO

500MG

AB1
IMPAX LABS

500MG

AB1
INVENTIA HLTHCARE

500MG

AB1
MYLAN

500MG

AB1
NOSTRUM PHARMS LLC

500MG

AB1
SANDOZ

500MG

AB1
SUN PHARM INDS (IN)

500MG

AB1
TEVA

500MG

AB1
TORRENT PHARM

500MG

AB1
ZYDUS PHARMS USA

500MG

FORTAMET

AB2
ANDRX LABS LLC

500MG

AB2 +

1GM

METFORMIN HYDROCHLORIDE

AB2
LUPIN LTD

500MG

AB2

1GM

AB2
MYLAN PHARMS INC

500MG

AB2

1GM

AB3
LUPIN LTD

500MG

AB3

1GM

GLUMETZA

SANTARUS INC

500MG

+

1GM

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

ACTOPLUS MET

AB
TAKEDA PHARMS USA
500MG;EQ 15MG BASE

AB
+
850MG;EQ 15MG BASE

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

AB
AUROBINDO PHARMA LTD
500MG;EQ 15MG BASE

AB
850MG;EQ 15MG BASE

AB
MACLEODS PHARMS LTD
500MG;EQ 15MG BASE

AB

850MG;EQ 15MG BASE

AB
MYLAN

500MG;EQ 15MG BASE

AB

850MG;EQ 15MG BASE

AB
SANDOZ

500MG;EQ 15MG BASE

AB

850MG;EQ 15MG BASE

AB
TEVA PHARMS USA

500MG;EQ 15MG BASE

AB

850MG;EQ 15MG BASE

A203686
A203686
A077064
A077064
A077064
A075972
A075972

002
003
001
002
003
005
004

Aug
Aug
Apr
Apr
Apr
Jan
Jan

28,
28,
18,
18,
18,
24,
24,

2014

2014

2005

2005

2005

2002

2002

N021202 004 Apr 11, 2003

A076869
A078596
A076706
A079118
A076863
A078321
A076985
A077113
A076756
A077336
A076864
A077078

001
002
002
002
001
002
001
001
002
002
001
001

Apr
Jan
Dec
Jul
Oct
Apr
Sep
Sep
Dec
Feb
Apr
Apr

12,
03,
29,
20,
14,
17,
13,
08,
12,
09,
12,
21,

2005

2008

2005

2012

2004

2008

2005

2005

2011

2006

2005

2005

N021202 001 Oct 13, 2000

A076172
A078596
A076706
A079118
A078321
A076249
A201991
A076650
A076756
A076873
A077336
A076269
A090014
A077060

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jan
Dec
Jul
Apr
Jul
Jan
Sep
Jul
Dec
Feb
Jun
Dec
Apr

16,
03,
14,
20,
17,
30,
18,
13,
26,
14,
09,
18,
30,
20,

2004

2008

2004

2012

2008

2004

2012

2005

2006

2004

2006

2004

2009

2005

N021574 001 Apr 27, 2004

N021574 002 Apr 27, 2004

A090692
A090692
A200690
A200690
A091664
A091664

001
002
001
002
001
002

Jun
Jun
Aug
Aug
Jul
Jul

29,
29,
01,
01,
19,
19,

2011

2011

2012

2012

2013

2013

N021748 001 Jun 03, 2005

N021748 002 Jun 03, 2005

N021842 001 Aug 29, 2005

N021842 002 Aug 29, 2005

A200823
A200823
A204802
A204802
A090406
A090406
A091273
A091273
A091155
A091155

001
002
001
002
001
002
001
002
001
002

Feb
Feb
Nov
Nov
Feb
Feb
Apr
Apr
Mar
Mar

13,
13,
05,
05,
25,
25,
16,
16,
10,
10,

2013

2013

2015

2015

2011

2011

2013

2013

2014

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-248(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

AB
TORRENT PHARMS LTD
500MG;EQ 15MG BASE
AB
850MG;EQ 15MG BASE
TABLET, EXTENDED RELEASE;ORAL

ACTOPLUS MET XR

TAKEDA PHARMS USA
1GM;EQ 15MG BASE
+
1GM;EQ 30MG BASE

A202001 001 Feb 13, 2013

A202001 002 Feb 13, 2013

N022024 001 May 12, 2009

N022024 002 May 12, 2009

METFORMIN HYDROCHLORIDE; REPAGLINIDE

TABLET;ORAL

PRANDIMET

AB
NOVO NORDISK INC
500MG;1MG
AB
+
500MG;2MG
REPAGLINIDE AND METFORMIN HYDROCHLORIDE

AB
LUPIN LTD
500MG;1MG
AB
500MG;2MG

A200624 001 Jul 15, 2015

A200624 002 Jul 15, 2015

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET;ORAL

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

TEVA
500MG;EQ 2MG BASE
500MG;EQ 4MG BASE
+
1GM;EQ 4MG BASE
1GM;EQ 2MG BASE

A077337
A077337
A077337
A077337

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

KOMBIGLYZE XR

ASTRAZENECA AB
500MG;EQ 5MG BASE
1GM;EQ 2.5MG BASE
+
1GM;EQ 5MG BASE

N200678 001 Nov 05, 2010

N200678 003 Nov 05, 2010

N200678 002 Nov 05, 2010

N022386 001 Jun 23, 2008

N022386 002 Jun 23, 2008

001
002
004
003

May
May
May
May

07,
07,
07,
07,

2014

2014

2014

2014

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

TABLET;ORAL

JANUMET

MERCK SHARP DOHME
500MG;EQ 50MG BASE
+
1GM;EQ 50MG BASE
TABLET, EXTENDED RELEASE;ORAL

JANUMET XR

MERCK SHARP DOHME
500MG;EQ 50MG BASE
1GM;EQ 50MG BASE
+
1GM;EQ 100MG BASE

N202270 001 Feb 02, 2012

N202270 002 Feb 02, 2012

N202270 003 Feb 02, 2012

METHACHOLINE CHLORIDE

FOR SOLUTION;INHALATION

PROVOCHOLINE

+ METHAPHARM

N019193 001 Oct 31, 1986

100MG/VIAL

METHADONE HYDROCHLORIDE

CONCENTRATE;ORAL

METHADONE HYDROCHLORIDE

AA
ROXANE
10MG/ML
AA
VISTAPHARM
10MG/ML
METHADONE HYDROCHLORIDE INTENSOL

AA
ROXANE
10MG/ML
METHADOSE

AA
+ MALLINCKRODT
10MG/ML
INJECTABLE;INJECTION

DOLOPHINE HYDROCHLORIDE

+ MYLAN INSTITUTIONAL
10MG/ML
POWDER;FOR RX COMPOUNDING

METHADONE HYDROCHLORIDE

MALLINCKRODT
50GM/BOT
100GM/BOT
500GM/BOT
SOLUTION;ORAL

METHADONE HYDROCHLORIDE

AA
+ ROXANE
5MG/5ML
AA
+
10MG/5ML
AA
VISTAPHARM
5MG/5ML
AA
10MG/5ML

N022044 001 Mar 30, 2007

N022044 002 Mar 30, 2007

A040180 001 Apr 30, 1998

A040088 001 Nov 30, 1994

A089897 001 Sep 06, 1988

N017116 002

N021624 001

N006383 002

N006383 003

N006383 004

A087393
A087997
A090707
A090707

001

001 Aug 30, 1982

001 Jun 30, 2010

002 Jun 30, 2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-249(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METHADONE HYDROCHLORIDE

TABLET;ORAL

DOLOPHINE HYDROCHLORIDE

AA
+ ROXANE
AA
+
METHADONE HYDROCHLORIDE

AA
AUROLIFE PHARMA LLC
AA
AA
COREPHARMA
AA
AA
MALLINCKRODT
AA
AA
SANDOZ
AA
THE PHARMANETWORK
METHADOSE

AA
MALLINCKRODT
AA
TABLET, FOR SUSPENSION;ORAL

METHADONE HYDROCHLORIDE

AA
MALLINCKRODT INC
AA
+ ROXANE
AA
SANDOZ
METHADOSE

AA
MALLINCKRODT

5MG
10MG

N006134 002

N006134 010

5MG
10MG
5MG
10MG
5MG
10MG
10MG
10MG

A203502
A203502
A090065
A090065
A040517
A040517
A040241
A090635

5MG
10MG

A040050 001 Apr 15, 1993

A040050 002 Apr 15, 1993

40MG
40MG
40MG

A077142 001 Jul 12, 2005

N017058 001

A075082 001 Mar 25, 1998

40MG

A074184 001 Apr 29, 1993

METHAMPHETAMINE HYDROCHLORIDE

TABLET;ORAL

DESOXYN

AA
+ RECORDATI RARE
5MG
METHAMPHETAMINE HYDROCHLORIDE

AA
COASTAL PHARMS
5MG
AA
ROXANE
5MG
METHAZOLAMIDE

TABLET;ORAL

METHAZOLAMIDE

AB
ANI PHARMS INC
AB
AB
MIKART
AB
+
AB
SANDOZ
AB
METHENAMINE HIPPURATE

TABLET;ORAL

HIPREX

AB
+ SANOFI AVENTIS US
METHENAMINE HIPPURATE

AB
COREPHARMA
UREX

AB
CNTY LINE PHARMS
METHIMAZOLE

TABLET;ORAL

METHIMAZOLE

AB
CEDAR PHARMS
AB
AB
HERITAGE PHARMA
AB
AB
MYLAN
AB
+
AB
SANDOZ
AB
AB
SUN PHARM INDS INC
AB
AB
VINTAGE PHARMS
AB
TAPAZOLE

AB
KING PHARMS
AB

001
002
001
002
001
002
002
001

Aug
Aug
Aug
Aug
Apr
Apr
May
Nov

31,
31,
18,
18,
27,
27,
29,
25,

2015

2015

2015

2015

2004

2004

1998

2009

N005378 002

A091189 001 Apr 21, 2010

A203846 001 Nov 17, 2015

25MG
50MG
25MG
50MG
25MG
50MG

A040001
A040001
A040062
A040062
A040036
A040036

001
002
001
002
001
002

1GM

N017681 001

1GM

A076411 001 Jun 20, 2003

1GM

N016151 001

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A040547
A040547
A040734
A040734
A040350
A040350
A040411
A040411
A040870
A040870
A202068
A202068

5MG
10MG

A040320 001 Mar 31, 2000

A040320 002 Mar 31, 2000

001
002
001
002
001
002
001
002
001
002
001
002

Jun
Jun
Jan
Jan
Jun
Jun

Feb
Feb
Dec
Dec
Mar
Mar
Mar
Mar
Sep
Sep
Mar
Mar

30,
30,
27,
27,
30,
30,

18,
18,
14,
14,
29,
29,
27,
27,
25,
25,
07,
07,

1993

1993

1994

1994

1993

1993

2005

2005

2007

2007

2000

2000

2001

2001

2007

2007

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-250(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METHOCARBAMOL

SOLUTION;IM-IV

METHOCARBAMOL

AP
MYLAN INSTITUTIONAL
ROBAXIN

AP
+ EUROHLTH INTL SARL
TABLET;ORAL

METHOCARBAMOL

AA
AUSTARPHARMA LLC
AA
AA
HETERO LABS LTD III
AA
AA
HIKMA INTL PHARMS
AA
AA
LANNETT HOLDINGS INC
AA
AA
PRINSTON INC
AA
AA
SANDOZ
AA
AA
VINTAGE PHARMS
AA
AA
WATSON LABS
AA
ROBAXIN

AA
+ AUXILIUM PHARMS LLC
ROBAXIN-750

AA
+ AUXILIUM PHARMS LLC
METHOHEXITAL SODIUM

INJECTABLE;INJECTION

BREVITAL SODIUM

+ PAR STERILE PRODUCTS
+
+
METHOTREXATE

SOLUTION;SUBCUTANEOUS

OTREXUP

ANTARES PHARMA INC

+
RASUVO

MEDAC PHARMA INC

1GM/10ML (100MG/ML)

A204404 001 Dec 05, 2014

1GM/10ML (100MG/ML)

N011790 001

500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG

A200958
A200958
A090200
A090200
A085159
A085123
A084756
A084756
A086989
A086988
A084616
A084615
A040489
A040489
A084277
A084276

500MG

N011011 004

750MG

N011011 006

200MG/VIAL
500MG/VIAL
2.5GM/VIAL

N011559 004 Dec 21, 2012

N011559 001

N011559 002

7.5MG/0.4ML (7.5MG/0.4ML)
10MG/0.4ML (10MG/0.4ML)
15MG/0.4ML (15MG/0.4ML)
20MG/0.4ML (20MG/0.4ML)
25MG/0.4ML (25MG/0.4ML)

N204824
N204824
N204824
N204824
N204824

005
001
002
003
004

Nov
Oct
Oct
Oct
Oct

07,
11,
11,
11,
11,

2014

2013

2013

2013

2013

7.5MG/0.15ML (7.5MG/0.15ML)
10MG/0.20ML (10MG/0.20ML)
12.5MG/0.25ML (12.5MG/0.25ML)
15MG/0.30ML (15MG/0.30ML)
17.5MG/0.35ML (17.5MG/0.35ML)
20MG/0.4ML (20MG/0.4ML)
22.5MG/0.45ML (22.5MG/0.45ML)
25MG/0.5ML (25MG/0.5ML)
27.5MG/0.55ML (27.5MG/0.55ML)
30MG/0.6ML (30MG/0.6ML)

N205776
N205776
N205776
N205776
N205776
N205776
N205776
N205776
N205776
N205776

001
002
003
004
005
006
007
008
009
010

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

10,
10,
10,
10,
10,
10,
10,
10,
10,
10,

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

METHOTREXATE SODIUM

INJECTABLE;INJECTION

METHOTREXATE PRESERVATIVE FREE

AP
FRESENIUS KABI USA
EQ 25MG BASE/ML
AP
EQ 1GM BASE/VIAL
AP
PHARMACHEMIE BV
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
METHOTREXATE SODIUM

AP
+ EUROHLTH INTL SARL
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
AP
+ FRESENIUS KABI USA
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
AP
+
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
AP
+ HOSPIRA
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
METHOTREXATE SODIUM PRESERVATIVE FREE

AP
+ ACCORD HLTHCARE
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
AP
+
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
AP
+
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
AP
EBEWE PHARMA
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
AP
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
AP
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

001
002
001
002
001

001

002
001

001

001

001

001

001
002
001

002

Oct
Oct
Nov
Nov

21,
21,
06,
06,

2011

2011

2009

2009

Mar 31, 2003

Jan 29, 2003

Jan 29, 2003

A040265 001 Feb 26, 1999

A040266 001 Feb 26, 1999

A200171 001 Feb 27, 2012

A089341
A040263
A040263
N011719

001
001
002
010

Sep
Feb
Feb
Dec

16,
26,
26,
15,

1986

1999

1999

2004

A040767
A040768
A040716
A090039
A090039
A090029

001
001
001
001
002
001

Apr
Apr
Apr
Mar
Mar
Mar

30,
30,
30,
31,
31,
31,

2007

2007

2007

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-251(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METHOTREXATE SODIUM

INJECTABLE;INJECTION

METHOTREXATE SODIUM PRESERVATIVE FREE

AP
+ EUROHLTH INTL SARL
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
AP
+
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
AP
+ HOSPIRA
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
AP
MYLAN LABS LTD
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
AP
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
AP
EQ 200MG BASE/8ML (EQ 25MG BASE/ML)
AP
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
AP
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
AP
PHARMACHEMIE BV
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
AP
EQ 250MG/10ML (EQ 25MG BASE/ML)
AP
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
METHOTREXATE SODIUM

+ EUROHLTH INTL SARL
EQ 200MG BASE/8ML (EQ 25MG BASE/ML)
METHOTREXATE SODIUM PRESERVATIVE FREE

+ EUROHLTH INTL SARL
EQ 1GM BASE/VIAL
TABLET;ORAL

METHOTREXATE SODIUM

AB
BARR
EQ 2.5MG BASE
AB
+ DAVA PHARMS INC
EQ 2.5MG BASE
AB
MYLAN
EQ 2.5MG BASE
AB
ORION CORP ORION
EQ 2.5MG BASE
AB
ROXANE
EQ 2.5MG BASE
TREXALL

BARR
EQ 5MG BASE
EQ 7.5MG BASE
EQ 10MG BASE
+
EQ 15MG BASE
METHOXSALEN

CAPSULE;ORAL

METHOXSALEN

AB
ACTAVIS INC
AB
STRIDES PHARMA
OXSORALEN-ULTRA

AB
+ DOW PHARM
8-MOP

+ VALEANT PHARM INTL
INJECTABLE;INJECTION

UVADEX

+ THERAKOS
LOTION;TOPICAL

OXSORALEN

+ VALEANT PHARM INTL

A089340
A089343
N011719
A201529
A201529
A201529
A201529
A201530
A040850
A040853
A040843

001
001
012
001
002
003
004
001
001
001
001

Sep
Sep
Apr
Mar
Mar
Mar
Mar
Mar
Jan
Jan
Jan

16,
16,
13,
29,
29,
29,
29,
29,
11,
11,
11,

1986

1986

2005

2012

2012

2012

2012

2012

2010

2010

2010

A089342 001 Sep 16, 1986

A040632 001 Aug 12, 2005

A081099
N008085
A081235
A201749
A040054

001
002

001
001
001

Oct 15, 1990

A040385
A040385
A040385
A040385

001
002
003
004

Mar
Mar
Mar
Mar

May 15, 1992

May 21, 2015

Aug 01, 1994

21,
21,
21,
21,

2001

2001

2001

2001

10MG
10MG

A202603 001 Jun 09, 2015

A202687 001 Jun 05, 2014

10MG

N019600 001 Oct 30, 1986

10MG

N009048 001

0.02MG/ML

N020969 001 Feb 25, 1999

1%

N009048 002

METHSCOPOLAMINE BROMIDE

TABLET;ORAL

METHSCOPOLAMINE BROMIDE

AA
BAYSHORE PHARMS LLC
AA
AA
BRECKENRIDGE PHARM
AA
AA
+ VINTAGE PHARMS
AA
+

2.5MG
5MG
2.5MG
5MG
2.5MG
5MG

A200602
A200602
A040642
A040642
A040624
A040624

METHSUXIMIDE

CAPSULE;ORAL

CELONTIN

PARKE DAVIS
+

150MG
300MG

N010596 007

N010596 008

METHYCLOTHIAZIDE

TABLET;ORAL

METHYCLOTHIAZIDE

+ MYLAN PHARMS INC

5MG

A087672 001 Aug 17, 1982

METHYLDOPA

TABLET;ORAL

METHYLDOPA

AB
ACCORD HLTHCARE
AB
AB
IVAX SUB TEVA PHARMS
AB

250MG
500MG
250MG
500MG

A070084
A070085
A070098
A070343

001
002
001
002
001
002

001
001
001
001

Sep
Sep
Dec
Dec
Dec
Dec

Oct
Oct
Feb
Feb

24,
24,
06,
06,
28,
28,

15,
15,
20,
20,

2012

2012

2011

2011

2006

2006

1985

1985

1986

1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-252(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METHYLDOPA

TABLET;ORAL

METHYLDOPA

AB
MYLAN
AB
+
AB
WATSON LABS

250MG

500MG

500MG

A070076 002 Apr 18, 1985

A070076 001 Apr 18, 1985

A070625 001 Jun 06, 1986

METHYLDOPATE HYDROCHLORIDE

INJECTABLE;INJECTION

METHYLDOPATE HYDROCHLORIDE

AP
+ LUITPOLD

50MG/ML

METHYLERGONOVINE MALEATE

INJECTABLE;INJECTION

METHERGINE

AP
+ EDISON THERAPS LLC

METHYLERGONOVINE MALEATE

AP
ERGOJECT

AP
LUITPOLD

TABLET;ORAL

METHERGINE

AB
+ EDISON THERAPS LLC

METHYLERGONOVINE MALEATE

AB
NOVEL LABS INC

METHYLNALTREXONE BROMIDE

SOLUTION;SUBCUTANEOUS

RELISTOR

SALIX PHARMS

+

+

A071279 001 Oct 02, 1987

0.2MG/ML

N006035 004

0.2MG/ML

0.2MG/ML

A040889 001 Sep 13, 2010

A090193 001 Nov 24, 2008

0.2MG

N006035 003

0.2MG

A091577 001 May 02, 2011

8MG/0.4ML (8MG/0.4ML)

12MG/0.6ML (12MG/0.6ML)

12MG/0.6ML (12MG/0.6ML)

N021964 002 Sep 27, 2010

N021964 001 Apr 24, 2008

N021964 003 Sep 27, 2010

METHYLPHENIDATE

FILM, EXTENDED RELEASE;TRANSDERMAL

DAYTRANA

NOVEN PHARMS INC
10MG/9HR
15MG/9HR
20MG/9HR
+
30MG/9HR
METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

AB1
BARR LABS INC
10MG
AB1
20MG
AB1
30MG
AB1
40MG
AB1
WATSON LABS INC
20MG
AB1
30MG
AB1
40MG
RITALIN LA
AB1
NOVARTIS
10MG
AB1
20MG
AB1
30MG
AB1
40MG
METADATE CD
AB2
UCB INC
10MG
AB2
20MG
AB2
30MG
AB2
40MG
AB2
50MG
AB2 +
60MG
METHYLPHENIDATE HYDROCHLORIDE

AB2
MALLINCKRODT INC
10MG
AB2
20MG
AB2
30MG
AB2
40MG
AB2
50MG
AB2
60MG
AB2
TEVA PHARMS
10MG
AB2
20MG
AB2
30MG
AB2
40MG
AB2
50MG
AB2
60MG

(1.1MG/HR)

(1.6MG/HR)

(2.2MG/HR)

(3.3MG/HR)

N021514
N021514
N021514
N021514

001
002
003
004

Apr
Apr
Apr
Apr

06,
06,
06,
06,

2006

2006

2006

2006

A079031
A079031
A079031
A079031
A078458
A078458
A078458

004
001
002
003
001
002
003

Oct
Jul
Jul
Jul
Dec
Dec
Dec

15,
13,
13,
13,
01,
01,
01,

2014

2012

2012

2012

2011

2011

2011

N021284
N021284
N021284
N021284

004
001
002
003

Apr
Jun
Jun
Jun

10,
05,
05,
05,

2004

2002

2002

2002

N021259
N021259
N021259
N021259
N021259
N021259

003
001
002
004
005
006

May
Apr
Jun
Feb
Feb
Feb

27,
03,
19,
19,
19,
19,

2003

2001

2003

2006

2006

2006

A203583
A203583
A203583
A203583
A203583
A203583
A077707
A077707
A077707
A078873
A078873
A078873

001
002
003
004
005
006
001
002
003
001
002
003

Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul

29,
29,
29,
29,
29,
29,
19,
19,
19,
19,
19,
19,

2015

2015

2015

2015

2015

2015

2012

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-253(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

APTENSIO XR

RHODES PHARMS
10MG
15MG
20MG
30MG
40MG
50MG
+
60MG
RITALIN LA

+ NOVARTIS
60MG
FOR SUSPENSION, EXTENDED RELEASE;ORAL

QUILLIVANT XR

+ NEXTWAVE PHARMS
5MG/ML
SOLUTION;ORAL

METHYLIN

AA
+ MALLINCKRODT
5MG/5ML
AA
+
10MG/5ML
METHYLPHENIDATE HYDROCHLORIDE

AA
NOVEL LABS INC
5MG/5ML
AA
10MG/5ML
AA
SUN PHARM INDS INC
5MG/5ML
AA
10MG/5ML
AA
TRIS PHARMA INC
5MG/5ML
AA
10MG/5ML
TABLET;ORAL

METHYLPHENIDATE HYDROCHLORIDE

AB
ACTAVIS LABS FL INC
5MG
AB
10MG
AB
20MG
AB
ASCENT PHARMS INC
5MG
AB
10MG
AB
20MG
AB
COREPHARMA
5MG
AB
10MG
AB
20MG
AB
MALLINCKRODT
5MG
AB
10MG
AB
20MG
AB
NOVEL LABS INC
5MG
AB
10MG
AB
20MG
AB
SUN PHARM INDS INC
5MG
AB
10MG
AB
20MG
AB
UCB INC
5MG
AB
10MG
AB
20MG
AB
VINTAGE PHARMS
5MG
AB
10MG
AB
20MG
RITALIN

AB
NOVARTIS
5MG
AB
10MG
AB
+
20MG
TABLET, CHEWABLE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

NOVEL LABS INC
2.5MG
5MG
+
10MG
TABLET, EXTENDED RELEASE;ORAL

METADATE ER

AB
+ UCB INC
20MG
METHYLIN ER

AB
MALLINCKRODT INC
10MG
AB
20MG
METHYLPHENIDATE HYDROCHLORIDE

AB
ABHAI
10MG
AB
20MG
RITALIN-SR

AB
NOVARTIS
20MG

N205831
N205831
N205831
N205831
N205831
N205831
N205831

001
002
003
004
005
006
007

Apr
Apr
Apr
Apr
Apr
Apr
Apr

17,
17,
17,
17,
17,
17,
17,

2015

2015

2015

2015

2015

2015

2015

N021284 005 Oct 27, 2014

N202100 001 Sep 27, 2012

N021419 001 Dec 19, 2002

N021419 002 Dec 19, 2002

A204602
A204602
A201466
A201466
A091601
A091601

001
002
001
002
001
002

Aug
Aug
Nov
Nov
Jul
Jul

14,
14,
12,
12,
23,
23,

2015

2015

2013

2013

2010

2010

A040220
A040220
A040220
A207416
A207416
A207416
A091159
A091159
A091159
A040300
A040300
A040300
A207884
A207884
A207884
A090710
A090710
A090710
A086429
A085799
A086428
A202892
A202892
A202892

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001

001

001

001
002
003

Aug
Aug
Aug
Sep
Sep
Sep
Mar
Mar
Mar
Nov
Nov
Nov
Nov
Nov
Nov
Mar
Mar
Mar

29,
29,
29,
22,
22,
22,
12,
12,
12,
27,
27,
27,
13,
13,
13,
15,
15,
15,

1997

1997

1997

2015

2015

2015

2014

2014

2014

1998

1998

1998

2015

2015

2015

2012

2012

2012

Sep 23, 2014

Sep 23, 2014

Sep 23, 2014

N010187 003

N010187 006

N010187 010

A204115 001 Feb 25, 2015

A204115 002 Feb 25, 2015

A204115 003 Feb 25, 2015

A089601 001 Jun 01, 1988

A075629 001 May 09, 2000

A075629 002 May 09, 2000

A207488 001 Jun 09, 2015

A207488 002 Jun 09, 2015

N018029 001 Mar 30, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-254(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

BX
KREMERS URBAN PHARMS
18MG
BX
27MG
BX
36MG
BX
54MG
BX
MALLINCKRODT INC
27MG
BX
36MG
BX
54MG
CONCERTA

JANSSEN PHARMS
18MG
27MG
36MG
+
54MG
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL

QUILLICHEW ER

PFIZER INC
20MG
30MG
+
40MG
METHYLPREDNISOLONE

TABLET;ORAL

MEDROL

AB
PHARMACIA AND UPJOHN
AB
AB
AB
AB
+
METHYLPREDNISOLONE

AB
DURAMED PHARMS BARR
AB
JUBILANT CADISTA
AB
AB
AB
AB
SANDOZ
AB
VINTAGE PHARMS
AB
WATSON LABS
METHYLPREDNISOLONE ACETATE

INJECTABLE;INJECTION

DEPO-MEDROL

AB
+ PHARMACIA AND UPJOHN
AB
+
METHYLPREDNISOLONE ACETATE

AB
SANDOZ
AB
AB
AB
AB
TEVA PHARMS USA
AB
AB
AB
DEPO-MEDROL

+ PHARMACIA AND UPJOHN

A091695
A091695
A091695
A091695
A202608
A202608
A202608

001
002
003
004
001
002
003

Jul
Jul
Sep
Sep
Dec
Dec
Dec

09,
09,
23,
23,
28,
28,
28,

2013

2013

2013

2013

2012

2012

2012

N021121
N021121
N021121
N021121

001
004
002
003

Aug
Apr
Aug
Dec

01,
01,
01,
08,

2000

2002

2000

2000

N207960 001 Dec 04, 2015

N207960 002 Dec 04, 2015

N207960 003 Dec 04, 2015

2MG
4MG
8MG
16MG
32MG

N011153
N011153
N011153
N011153
N011153

002

001

004

003

006

4MG
4MG
8MG
16MG
32MG
4MG
4MG
4MG

A088497
A040189
A040189
A040189
A040189
A040194
A040183
A040232

001
001
002
003
004
001
001
001

40MG/ML
80MG/ML

N011757 001

N011757 004

40MG/ML
40MG/ML
80MG/ML
80MG/ML
40MG/ML
40MG/ML
80MG/ML
80MG/ML

A040719
A040794
A040719
A040794
A040557
A040620
A040557
A040620

20MG/ML

N011757 002

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE;INJECTION

A-METHAPRED

AP
HOSPIRA
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
AP
HOSPIRA INC
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
METHYLPREDNISOLONE SODIUM SUCCINATE

AP
AUROBINDO PHARMA LTD
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
FRESENIUS KABI USA
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
MUSTAFA NEVSAT
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
AP
EQ 500MG BASE/VIAL

001
001
002
002
001
001
002
002

Feb
Oct
Oct
Jul
Jul
Oct
Dec
Oct

21,
31,
31,
20,
20,
31,
22,
16,

1984

1997

1997

2007

2007

1997

1998

1997

Jan
Mar
Jan
Mar
Feb
Oct
Feb
Oct

29,
05,
29,
05,
23,
27,
23,
27,

2009

2009

2009

2009

2005

2006

2005

2006

A040664
A040665
A040793
A040827

001
001
001
001

Dec
Dec
Nov
Nov

20,
20,
25,
25,

2005

2005

2008

2008

A207667
A207667
A207667
A207667
A040583
A040583
A040612
A040888
A040888
A040888

001
002
003
004
001
002
001
001
002
003

Dec
Dec
Dec
Dec
Jul
Jul
Aug
Jul
Jul
Jul

15,
15,
15,
15,
30,
30,
12,
18,
18,
18,

2015

2015

2015

2015

2004

2004

2004

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-255(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE;INJECTION

METHYLPREDNISOLONE SODIUM SUCCINATE

AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
SOLU-MEDROL

AP
+ PHARMACIA AND UPJOHN
EQ 40MG BASE/VIAL
AP
+
EQ 125MG BASE/VIAL
AP
+
EQ 500MG BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
METHYLTESTOSTERONE

CAPSULE;ORAL

METHYLTESTOSTERONE

AB
IMPAX LABS INC
TESTRED

AB
+ VALEANT PHARM INTL
TABLET;ORAL

ANDROID 10

BP
VALEANT PHARM INTL
ANDROID 25

BP
VALEANT PHARM INTL
METHYLTESTOSTERONE

BP
IMPAX LABS
BP
METIPRANOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

METIPRANOLOL

AT
ALCON RES LTD
OPTIPRANOLOL

AT
+ BAUSCH AND LOMB

A040888 004 Jul 18, 2011

A040888 005 Jul 18, 2011

N011856
N011856
N011856
N011856
N011856

003

004

005

006

007 Feb 27, 1985

10MG

A204851 001 Sep 21, 2015

10MG

A083976 001

10MG

A086450 001

25MG

A087147 001

10MG
25MG

A080767 002

A084310 001

0.3%

A075720 001 Aug 06, 2001

0.3%

N019907 001 Dec 29, 1989

METOCLOPRAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

METOCLOPRAMIDE

AP
EMCURE PHARMS LTD
EQ 5MG BASE/ML
METOCLOPRAMIDE HYDROCHLORIDE

AP
BD RX
EQ 5MG BASE/ML
AP
+ HOSPIRA
EQ 5MG BASE/ML
AP
TEVA PHARMS USA
EQ 5MG BASE/ML
SOLUTION;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

AA
ANI PHARMS
EQ 5MG BASE/5ML
AA
PHARM ASSOC
EQ 5MG BASE/5ML
AA
SILARX
EQ 5MG BASE/5ML
AA
VISTAPHARM
EQ 5MG BASE/5ML
AA
+ WOCKHARDT
EQ 5MG BASE/5ML
TABLET;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

AB
IPCA LABS LTD
EQ 5MG BASE
AB
EQ 10MG BASE
AB
MUTUAL PHARM
EQ 5MG BASE
AB
NORTHSTAR HLTHCARE
EQ 5MG BASE
AB
EQ 10MG BASE
AB
PAR PHARM INC
EQ 10MG BASE
AB
TEVA
EQ 5MG BASE
AB
EQ 10MG BASE
AB
VINTAGE PHARMS
EQ 5MG BASE
AB
EQ 10MG BASE
AB
WATSON LABS
EQ 5MG BASE
AB
EQ 10MG BASE
REGLAN

AB
ANI PHARMS
EQ 5MG BASE
AB
+
EQ 10MG BASE
TABLET, ORALLY DISINTEGRATING;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

AB
NOVEL LABS INC
EQ 5MG BASE
METOZOLV ODT

AB
+ SALIX PHARMS
EQ 5MG BASE
METOCLOPRAMIDE HYDROCHLORIDE

NOVEL LABS INC
EQ 10MG BASE

A204756 001 Dec 20, 2013

A091392 001 Apr 19, 2013

A073118 001 Jan 17, 1991

A073135 001 Nov 27, 1991

A071402
A072744
A073680
A075051
A074703

001
001
001
001
001

Jun
May
Oct
Jan
Oct

25,
28,
27,
26,
31,

1993

1991

1992

2001

1997

A078807
A078807
A071536
A078374
A078374
A070581
A072801
A070184
A077878
A077878
A072750
A071250

001
002
002
001
002
001
001
001
001
002
001
001

Jun
Jun
Jan
Nov
Nov
Oct
Jun
Jul
Aug
Aug
Dec
Feb

12,
12,
16,
30,
30,
17,
15,
29,
28,
28,
28,
03,

2008

2008

1997

2007

2007

1985

1993

1985

2006

2006

1995

1988

N017854 002 May 05, 1987

N017854 001

A202191 001 Aug 15, 2014

N022246 001 Sep 04, 2009

A202191 002 Aug 15, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-256(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METOLAZONE

TABLET;ORAL

METOLAZONE

AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
ZAROXOLYN

AB
UCB INC
AB
+
AB
+

2.5MG
5MG
10MG
2.5MG
5MG
10MG

A076698
A076698
A076698
A076732
A076466
A076466

2.5MG
5MG
10MG

N017386 001

N017386 002

N017386 003

METOPROLOL SUCCINATE

TABLET, EXTENDED RELEASE;ORAL

METOPROLOL SUCCINATE

AB
ACTAVIS LABS FL INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
DR REDDYS LABS LTD
EQ
AB
EQ
AB
MYLAN PHARMS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
REDDYS
EQ
AB
EQ
AB
WOCKHARDT
EQ
AB
EQ
AB
EQ
AB
EQ
TOPROL-XL

AB
ASTRAZENECA PHARMS
EQ
AB
+
EQ
AB
EQ
AB
+
EQ
METOPROLOL TARTRATE

INJECTABLE;INJECTION

LOPRESSOR

AP
+ NOVARTIS
METOPROLOL TARTRATE

AP
BEDFORD LABS
AP
CLARIS PHARMASERVICE
AP
FRESENIUS KABI USA
AP
GLAND PHARMA LTD
AP
HIKMA FARMACEUTICA
AP
HOSPIRA
AP
AP
AP
LUITPOLD
AP
AP
SAGENT STRIDES
AP
SANDOZ
TABLET;ORAL

LOPRESSOR

AB
US PHARMS HOLDINGS I
AB
METOPROLOL TARTRATE

AB
ALEMBIC PHARMS LTD
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
IPCA LABS LTD
AB
AB
AB
MUTUAL PHARM
AB
AB

001
002
003
001
001
002

Dec
Oct
Oct
Dec
Dec
Dec

23,
19,
19,
19,
19,
19,

2003

2004

2004

2003

2003

2003

25MG TARTRATE
50MG TARTRATE
100MG TARTRATE
200MG TARTRATE
25MG TARTRATE
50MG TARTRATE
25MG TARTRATE
50MG TARTRATE
100MG TARTRATE
200MG TARTRATE
100MG TARTRATE
200MG TARTRATE
25MG TARTRATE
50MG TARTRATE
100MG TARTRATE
200MG TARTRATE

A077118
A076862
A077298
A077298
A090617
A090617
A202033
A202033
A202033
A202033
A078889
A078889
A090615
A090615
A090615
A090615

001
001
001
002
001
002
001
002
003
004
001
002
001
002
003
004

Aug
Aug
Apr
Apr
Aug
Aug
Dec
Dec
Dec
Dec
Aug
Aug
Jul
Jul
Jul
Jul

03,
03,
15,
15,
01,
01,
15,
15,
15,
15,
15,
15,
22,
22,
22,
22,

2009

2009

2010

2010

2012

2012

2011

2011

2011

2011

2012

2012

2010

2010

2010

2010

25MG TARTRATE
50MG TARTRATE
100MG TARTRATE
200MG TARTRATE

N019962
N019962
N019962
N019962

004
001
002
003

Feb
Jan
Jan
Jan

05,
10,
10,
10,

2001

1992

1992

1992

1MG/ML

N018704 001 Mar 30, 1984

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML

A076495
A078950
A091045
A204205
A077761
A074133
A075160
A078085
A090386
A091307
A090317
A077360

50MG
100MG

N017963 001

N017963 002

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A202871
A202871
A202871
A077739
A077739
A077739
A078459
A078459
A078459
A073654
A073653
A073654

001
001
001
001
001
001
001
001
001
001
001
001

001
002
003
001
002
003
001
002
003
002
001
001

Jul
Apr
Oct
Aug
May
Dec
Jul
Apr
Sep
Dec
Apr
Oct

07,
29,
25,
27,
30,
21,
06,
29,
30,
29,
19,
02,

2003

2013

2010

2014

2007

1993

1998

2008

2009

2010

2010

2007

May
May
May
Sep
Sep
Sep
Jun
Jun
Jun
Jul
Dec
Dec

28,
28,
28,
11,
11,
11,
17,
17,
17,
15,
21,
21,

2013

2013

2013

2007

2007

2007

2008

2008

2008

2009

1993

1993

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-257(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METOPROLOL TARTRATE

TABLET;ORAL

METOPROLOL TARTRATE

AB
MYLAN
AB
AB
+
AB
RUBICON RES PVT LTD
AB
AB
AB
SANDOZ
AB
AB
SUN PHARM INDS INC
AB
AB
AB
TEVA
AB
AB
WATSON LABS
AB
MYLAN

25MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
50MG
100MG
37.5MG
75MG

METRONIDAZOLE

CAPSULE;ORAL

FLAGYL

AB
+ GD SEARLE LLC
375MG
METRONIDAZOLE

AB
ALEMBIC LTD
375MG
AB
PAR PHARM
375MG
CREAM;TOPICAL

METROCREAM

AB
+ GALDERMA LABS LP
0.75%
METRONIDAZOLE

AB
FOUGERA PHARMS
0.75%
AB
G AND W LABS
0.75%
NORITATE

+ VALEANT PHARMS NORTH
1%
GEL;TOPICAL

METROGEL

AB
+ GALDERMA LABS LP
0.75%
AB
+
1%
METRONIDAZOLE

AB
FOUGERA PHARMS
0.75%
AB
G AND W LABS INC
0.75%
AB
TARO
0.75%
AB
TOLMAR
0.75%
AB
1%
GEL;VAGINAL

METROGEL-VAGINAL

AB
+ MEDICIS
0.75%
METRONIDAZOLE

AB
TOLMAR
0.75%
VANDAZOLE

BX
TEVA PHARMS
0.75%
NUVESSA

+ ACTAVIS LABS UT INC
1.3%
INJECTABLE;INJECTION

FLAGYL I.V. RTU IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
500MG/100ML
METRO I.V. IN PLASTIC CONTAINER

AP
+ B BRAUN
500MG/100ML
METRONIDAZOLE IN PLASTIC CONTAINER

AP
CLARIS PHARMASERVICE
500MG/100ML
AP
+ HOSPIRA
500MG/100ML
LOTION;TOPICAL

METROLOTION

AB
+ GALDERMA LABS LP
0.75%
METRONIDAZOLE

AB
FOUGERA PHARMS
0.75%
TABLET;ORAL

FLAGYL

AB
GD SEARLE LLC
250MG
AB
+
500MG

A076704
A076704
A076704
A200981
A200981
A200981
A073288
A073289
A076670
A074644
A074644
A074141
A074141
A074217
A074217
A076704
A076704

001
002
003
001
002
003
001
001
001
001
002
001
002
001
002
004
005

Jan
Jan
Jan
Oct
Oct
Oct
Mar
Mar
Jan
Dec
Dec
Jan
Jan
May
May
Mar
Mar

16,
16,
16,
28,
28,
28,
25,
25,
15,
10,
10,
31,
31,
27,
27,
18,
18,

2004

2004

2004

2014

2014

2014

1994

1994

2004

1996

1996

1995

1995

1994

1994

2015

2015

N020334 001 May 03, 1995

A079065 001 Jun 23, 2009

A076522 001 Jan 29, 2004

N020531 001 Sep 20, 1995

A076408 001 May 28, 2004

A077549 001 Dec 19, 2007

N020743 001 Sep 26, 1997

N019737 001 Nov 22, 1988

N021789 001 Jun 30, 2005

A077018
A078178
A077819
A077547
A090903

001
001
001
001
001

Jun
Jan
Jul
Jul
Jul

06,
19,
18,
13,
22,

2006

2011

2006

2006

2011

N020208 001 Aug 17, 1992

A077264 001 Oct 31, 2006

N021806 001 May 20, 2005

N205223 001 Mar 24, 2014

N018657 001

N018900 001 Sep 29, 1983

A078084 001 Mar 31, 2008

N018890 002 Nov 18, 1983

N020901 001 Nov 24, 1998

A077197 001 May 24, 2006

N012623 001

N012623 003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-258(of 388)

PRESCRIPTION DRUG PRODUCT LIST

METRONIDAZOLE

TABLET;ORAL

METRONIDAZOLE

AB
ALEMBIC PHARMS LTD

250MG

AB

500MG

AB
APPCO PHARMA LLC

250MG

AB

500MG

AB
AUROBINDO PHARMA LTD
250MG

AB

500MG

AB
MUTUAL PHARM

250MG

AB

500MG

AB
PLIVA

500MG

AB
TEVA PHARMS USA

250MG

AB
UNICHEM LABS LTD

250MG

AB

500MG

AB
WATSON LABS

250MG

AB
WATSON LABS INC

500MG

TABLET, EXTENDED RELEASE;ORAL

FLAGYL ER

AB
+ GD SEARLE LLC

750MG

METRONIDAZOLE

AB
ALEMBIC LTD

750MG

A079067
A079067
A205245
A205245
A203974
A203974
A070772
A070773
A070033
A070027
A203458
A203458
A070035
A070044

001
002
001
002
001
002
001
001
001
001
001
002
001
001

Mar
Mar
Sep
Sep
May
May
Jul
Jul
Dec
Nov
Jan
Jan
Dec
Feb

13,
13,
23,
23,
29,
29,
16,
16,
06,
06,
22,
22,
20,
08,

2009

2009

2015

2015

2015

2015

1986

1986

1984

1984

2014

2014

1984

1985

N020868 001 Nov 26, 1997

A090222 001 May 05, 2010

METYRAPONE

CAPSULE;ORAL

METOPIRONE

+ HRA PHARMA

250MG

N012911 002 Aug 09, 1996

METYROSINE

CAPSULE;ORAL

DEMSER

+ ATON PHARMA VPNA

250MG

N017871 001

150MG

200MG

250MG

A074377 001 May 16, 1995

A074377 002 May 16, 1995

A074377 003 May 16, 1995

MICAFUNGIN SODIUM

INJECTABLE;IV (INFUSION)

MYCAMINE

+ ASTELLAS

+

50MG/VIAL

100MG/VIAL

N021506 002 Mar 16, 2005

N021506 003 Jun 27, 2006

MICONAZOLE

TABLET;BUCCAL

ORAVIG

+ DARA BIOSCIENCES

50MG

N022404 001 Apr 16, 2010

200MG

A073508 001 Nov 19, 1993

200MG

N018888 001 Aug 15, 1984

MEXILETINE HYDROCHLORIDE

CAPSULE;ORAL

MEXILETINE HYDROCHLORIDE

TEVA

+

MICONAZOLE NITRATE

SUPPOSITORY;VAGINAL

MICONAZOLE NITRATE

AB
ACTAVIS MID ATLANTIC

MONISTAT 3

AB
+ MEDTECH PRODUCTS

MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE

OINTMENT;TOPICAL

VUSION

+ DELCOR ASSET

0.25%;81.35%;15%

N021026 001 Feb 16, 2006

MIDAZOLAM HYDROCHLORIDE

INJECTABLE;INJECTION

MIDAZOLAM HYDROCHLORIDE
AP
AKORN INC
AP
AP
AP
BEDFORD
AP
AP
BEDFORD LABS
AP
AP
EUROHLTH INTL SARL
AP
AP
FRESENIUS KABI USA

A075494
A075481
A075494
A075247
A075247
A075421
A075421
A075243
A075243
A075154

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1MG
5MG
5MG
1MG
5MG
1MG
5MG
1MG
5MG
1MG

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

001
001
002
002
001
002
001
001
002
002

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

30,
30,
30,
23,
23,
20,
20,
20,
20,
20,

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-259(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MIDAZOLAM HYDROCHLORIDE

INJECTABLE;INJECTION

MIDAZOLAM HYDROCHLORIDE

AP
EQ 5MG BASE/ML
AP
GLAND PHARMA LTD
EQ 1MG BASE/ML
AP
EQ 5MG BASE/ML
AP
HIKMA MAPLE
EQ 1MG BASE/ML
AP
EQ 5MG BASE/ML
AP
+ HOSPIRA
EQ 1MG BASE/ML
AP
EQ 1MG BASE/ML
AP
+
EQ 5MG BASE/ML
AP
EQ 5MG BASE/ML
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

AP
BD RX
EQ 1MG BASE/ML
AP
EQ 5MG BASE/ML
AP
+ HOSPIRA
EQ 1MG BASE/ML
AP
+
EQ 5MG BASE/ML
AP
SAGENT STRIDES
EQ 1MG BASE/ML
AP
EQ 5MG BASE/ML
MIDOZALAM HYDROCHLORIDE

AP
SAGENT STRIDES
EQ 1MG BASE/ML
AP
EQ 5MG BASE/ML
SYRUP;ORAL

MIDAZOLAM HYDROCHLORIDE

AA
HI TECH PHARMA
EQ 2MG BASE/ML
AA
PADDOCK LLC
EQ 2MG BASE/ML
AA
+ ROXANE
EQ 2MG BASE/ML
AA
SUN PHARM INDS LTD
EQ 2MG BASE/ML
MIDODRINE HYDROCHLORIDE

TABLET;ORAL

MIDODRINE HYDROCHLORIDE

AB
APOTEX INC
AB
AB
AB
IMPAX PHARMS
AB
AB
AB
MYLAN PHARMS INC
AB
+
AB
AB
SANDOZ
AB
AB
ORVATEN

AB
UPSHER SMITH
AB
AB
MIFEPRISTONE

TABLET;ORAL

KORLYM

+ CORCEPT THERAP
MIFEPREX

+ DANCO LABS LLC
MIGLITOL

TABLET;ORAL

GLYSET

AB
PHARMACIA AND UPJOHN
AB
AB
+
MIGLITOL

AB
ORIENT PHARMA CO LTD
AB
AB
MIGLUSTAT

CAPSULE;ORAL

ZAVESCA

+ ACTELION PHARMS LTD

A075154
A090696
A090850
A075324
A075324
A075293
A075856
A075293
A075856

001
001
001
001
002
001
001
002
002

Jun
Feb
Jan
Jun
Jun
Jun
Jun
Jun
Jun

20,
29,
25,
20,
20,
20,
13,
20,
13,

2000

2012

2012

2000

2000

2000

2002

2000

2002

A203460
A203460
A075857
A075857
A090315
A090315

001
002
001
002
001
002

Aug
Aug
Jul
Jul
Nov
Nov

22,
22,
22,
22,
29,
29,

2014

2014

2002

2002

2010

2010

A090316 001 May 04, 2011

A090316 002 May 04, 2011

A075958
A076379
A075873
A076058

001
001
001
001

Sep
May
Apr
Mar

04,
02,
30,
15,

2003

2005

2002

2002

2.5MG
5MG
10MG
2.5MG
5MG
10MG
2.5MG
5MG
10MG
2.5MG
5MG
10MG

A077746
A077746
A077746
A076449
A076449
A076449
A076577
A076577
A076577
A076514
A076514
A076514

001
002
003
001
002
003
001
002
003
001
002
003

Sep
Sep
Sep
May
May
Dec
Sep
Sep
Sep
Sep
Sep
Jul

12,
12,
12,
27,
27,
16,
10,
10,
10,
11,
11,
02,

2006

2006

2006

2004

2004

2005

2003

2003

2003

2003

2003

2004

2.5MG
5MG
10MG

A076725 001 Nov 03, 2004

A076725 002 Nov 03, 2004

A076725 003 Nov 03, 2004

300MG

N202107 001 Feb 17, 2012

200MG

N020687 001 Sep 28, 2000

25MG
50MG
100MG

N020682 001 Dec 18, 1996

N020682 002 Dec 18, 1996

N020682 003 Dec 18, 1996

25MG
50MG
100MG

A203965 001 Feb 24, 2015

A203965 002 Feb 24, 2015

A203965 003 Feb 24, 2015

100MG

N021348 001 Jul 31, 2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-260(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MILNACIPRAN HYDROCHLORIDE

TABLET;ORAL

SAVELLA

CYPRESS BIOSCIENCE
+

12.5MG
25MG
50MG
100MG

MILRINONE LACTATE

INJECTABLE;INJECTION

MILRINONE LACTATE

AP
BEDFORD
EQ 1MG BASE/ML
AP
EUROHLTH INTL SARL
EQ 1MG BASE/ML
AP
FRESENIUS KABI USA
EQ 1MG BASE/ML
AP
GLAND PHARMA LTD
EQ 1MG BASE/ML
AP
+ HIKMA FARMACEUTICA
EQ 1MG BASE/ML
AP
HOSPIRA INC
EQ 1MG BASE/ML
AP
INTL MEDICATED
EQ 1MG BASE/ML
MILRINONE LACTATE IN DEXTROSE 5%

AP
APOTEX INC
EQ 40MG BASE/200ML (EQ 0.2MG
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
B BRAUN
EQ 20MG BASE/100ML (EQ 0.2MG
AP
+ BAXTER HLTHCARE
EQ 20MG BASE/100ML (EQ 0.2MG
AP
+
EQ 40MG BASE/200ML (EQ 0.2MG
AP
BEDFORD LABS
EQ 20MG BASE/100ML (EQ 0.2MG
AP
EQ 40MG BASE/200ML (EQ 0.2MG
AP
HOSPIRA
EQ 20MG BASE/100ML (EQ 0.2MG
AP
EQ 40MG BASE/200ML (EQ 0.2MG
MILRINONE LACTATE IN PLASTIC CONTAINER

AP
HIKMA FARMACEUTICA
EQ 20MG BASE/100ML (EQ 0.2MG
AP
EQ 40MG BASE/200ML (EQ 0.2MG
MILTEFOSINE

CAPSULE;ORAL

IMPAVIDO

+ KNIGHT THERAPS

50MG

MINOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL

DYNACIN

AB
CNTY LINE PHARMS
EQ
AB
EQ
MINOCIN

AB
PRECISION DERMAT
EQ
AB
EQ
MINOCYCLINE HYDROCHLORIDE

AB
AUROBINDO PHARMA
EQ
AB
EQ
AB
EQ
AB
IMPAX LABS
EQ
AB
EQ
AB
EQ
AB
SUN PHARM INDS INC
EQ
AB
EQ
AB
EQ
AB
TEVA
EQ
AB
EQ
AB
+
EQ
AB
TORRENT PHARMA INC
EQ
AB
EQ
AB
EQ
AB
WATSON LABS
EQ
AB
EQ
AB
EQ
INJECTABLE;INJECTION

MINOCIN

+ REMPEX PHARMS INC
EQ
POWDER, EXTENDED RELEASE;DENTAL

ARESTIN

+ ORAPHARMA
EQ
TABLET;ORAL

MINOCYCLINE HYDROCHLORIDE

AB
DR REDDYS LABS LTD
EQ
AB
EQ

N022256
N022256
N022256
N022256

001
002
003
004

Jan
Jan
Jan
Jan

14,
14,
14,
14,

2009

2009

2009

2009

A075660
A075530
A075936
A077190
A077966
A203280
A076013

001
001
001
001
001
001
001

May
May
May
Oct
Dec
Sep
Aug

28,
28,
28,
31,
03,
03,
02,

2002

2002

2002

2006

2010

2014

2002

BASE/ML)

A077151 002 Jul 20, 2005

BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)

A076414
A075834
A075834
A078113
A078113
A075885
A075885

BASE/ML)
BASE/ML)

A090038 001 Jan 21, 2010

A090038 002 Jan 21, 2010

001
001
002
001
002
001
002

Aug
May
May
May
May
May
May

18,
28,
28,
21,
21,
28,
28,

2004

2002

2002

2008

2008

2002

2002

N204684 001 Mar 19, 2014

75MG BASE
100MG BASE

A063067 002 Sep 15, 1999

A063067 001 Jul 31, 1990

50MG BASE
100MG BASE

N050649 001 May 31, 1990

N050649 002 May 31, 1990

50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE

A065470
A065470
A065470
A065005
A065005
A065005
A090867
A090867
A090867
A063011
A063009
A063009
A065062
A065062
A065062
A063181
A063065
A063065

100MG BASE/VIAL

N050444 001

1MG BASE

N050781 001 Feb 16, 2001

50MG BASE
75MG BASE

A065436 001 Dec 26, 2007

A065436 002 Dec 26, 2007

001
002
003
001
003
002
001
002
003
001
002
001
001
002
003
001
002
001

Mar
Mar
Mar
Mar
Apr
Mar
May
May
May
Mar
Aug
Mar
Nov
Nov
Nov
Dec
Jun
Dec

11,
11,
11,
23,
18,
23,
13,
13,
13,
02,
12,
02,
30,
30,
30,
30,
10,
30,

2008

2008

2008

1999

2001

1999

2013

2013

2013

1992

2003

1992

2000

2000

2000

1991

1999

1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-261(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MINOCYCLINE HYDROCHLORIDE

TABLET;ORAL

MINOCYCLINE HYDROCHLORIDE

AB
EQ
AB
PAR PHARM
EQ
AB
EQ
AB
+
EQ
AB
TORRENT PHARMA INC
EQ
AB
EQ
AB
EQ
TABLET, EXTENDED RELEASE;ORAL

MINOCYCLINE HYDROCHLORIDE

AB
AUROBINDO PHARMA LTD
EQ
AB
EQ
AB
EQ
AB
BARR LABS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
IMPAX LABS INC
EQ
AB
EQ
AB
EQ
AB
LUPIN LTD
EQ
AB
EQ
AB
EQ
AB
MYLAN PHARMS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
SANDOZ
EQ
AB
EQ
AB
+
EQ
AB
SIDMAK LABS INDIA
EQ
AB
EQ
AB
EQ
AB
EQ
AB
SUN PHARM INDS LTD
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
SOLODYN

AB
MEDICIS
EQ
AB
EQ
AB
EQ
AB
+
EQ
EQ

100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE

A065436
A065131
A065131
A065131
A065156
A065156
A065156

003
001
002
003
001
002
003

Dec
Apr
Apr
Apr
Jan
Jan
Jan

26,
16,
16,
16,
06,
06,
06,

2007

2003

2003

2003

2004

2004

2004

45MG BASE
90MG BASE
135MG BASE
45MG BASE
65MG BASE
90MG BASE
115MG BASE
135MG BASE
45MG BASE
90MG BASE
135MG BASE
45MG BASE
90MG BASE
135MG BASE
45MG BASE
80MG BASE
90MG BASE
105MG BASE
135MG BASE
45MG BASE
90MG BASE
135MG BASE
45MG BASE
80MG BASE
105MG BASE
135MG BASE
45MG BASE
80MG BASE
90MG BASE
105MG BASE
135MG BASE

A202261
A202261
A202261
A065485
A065485
A065485
A065485
A065485
A090024
A090024
A090024
A091424
A091424
A091424
A090911
A203443
A090911
A203443
A090911
A090422
A090422
A090422
A204394
A204394
A204394
A204394
A091118
A091118
A091118
A091118
A091118

001
003
005
001
004
002
005
003
001
002
003
001
003
004
001
002
002
003
003
001
002
003
001
004
005
007
001
004
005
006
008

Nov
Nov
Nov
Mar
May
Mar
May
Mar
Feb
Feb
Feb
Nov
Nov
Nov
Jul
Aug
Jul
Aug
Jul
Aug
Aug
Aug
Dec
Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep

19,
19,
19,
17,
18,
17,
18,
17,
03,
03,
03,
30,
30,
30,
20,
22,
20,
22,
20,
13,
13,
13,
30,
30,
30,
30,
25,
25,
25,
25,
25,

2012

2012

2012

2009

2012

2009

2012

2009

2009

2009

2009

2011

2011

2011

2010

2014

2010

2014

2010

2009

2009

2009

2015

2015

2015

2015

2014

2014

2014

2014

2014

65MG BASE
80MG BASE
105MG BASE
115MG BASE
55MG BASE

N050808
N050808
N050808
N050808
N050808

004
007
006
005
008

Jul
Aug
Aug
Jul
Aug

23,
27,
27,
23,
27,

2009

2010

2010

2009

2010

001
001
001
001
001
001

Dec
Dec
Nov
Nov
Mar
Mar

14,
14,
14,
14,
03,
03,

1995

1995

1988

1988

1987

1987

MINOXIDIL

TABLET;ORAL

MINOXIDIL

AB
MUTUAL PHARM
AB
AB
PAR PHARM
AB
AB
WATSON LABS
AB
+

2.5MG
10MG
2.5MG
10MG
2.5MG
10MG

A072708
A072709
A071826
A071839
A071344
A071345

MIPOMERSEN SODIUM

SOLUTION;SUBCUTANEOUS

KYNAMRO

+ GENZYME CORP

200MG/ML (200MG/ML)

N203568 001 Jan 29, 2013

MIRABEGRON

TABLET, EXTENDED RELEASE;ORAL

MYRBETRIQ

APGDI
25MG
+
50MG

N202611 001 Jun 28, 2012

N202611 002 Jun 28, 2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-262(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MIRTAZAPINE

TABLET;ORAL

MIRTAZAPINE

AB
ACTAVIS LABS FL INC
15MG
AB
30MG
AB
45MG
AB
APOTEX INC
15MG
AB
30MG
AB
45MG
AB
AUROBINDO
7.5MG
AB
15MG
AB
30MG
AB
45MG
AB
MYLAN
15MG
AB
30MG
AB
45MG
AB
MYLAN PHARMS INC
15MG
AB
30MG
AB
45MG
AB
SANDOZ
15MG
AB
30MG
AB
45MG
AB
SUN PHARM INDS INC
7.5MG
AB
15MG
AB
30MG
AB
45MG
AB
TEVA
15MG
AB
30MG
AB
45MG
AB
WATSON LABS
15MG
AB
30MG
AB
45MG
REMERON

AB
+ ORGANON USA INC
15MG
AB
30MG
AB
45MG
TABLET, ORALLY DISINTEGRATING;ORAL

MIRTAZAPINE

AB
ACTAVIS LABS FL INC
15MG
AB
30MG
AB
45MG
AB
AUROBINDO PHARMA LTD
15MG
AB
30MG
AB
45MG
AB
TEVA
15MG
AB
30MG
AB
45MG
REMERON SOLTAB

AB
+ ORGANON USA INC
15MG
AB
30MG
AB
45MG
MISOPROSTOL

TABLET;ORAL

CYTOTEC

AB
GD SEARLE LLC
AB
+
MISOPROSTOL

AB
IVAX SUB TEVA PHARMS
AB
AB
NOVEL LABS INC
AB
MITOMYCIN

FOR SOLUTION;TOPICAL

MITOSOL

+ MOBIUS THERAP
INJECTABLE;INJECTION

MITOMYCIN

AP
+ ACCORD HLTHCARE
AP
+
AP
+
AP
BEDFORD

A076336
A076336
A076336
A077666
A077666
A077666
A076921
A076921
A076921
A076921
A076122
A076122
A076122
A076176
A076176
A076176
A076219
A076219
A076219
A076541
A076541
A076541
A076541
A076119
A076119
A076119
A076312
A076312
A076312

001
002
003
001
002
003
001
002
003
004
001
002
003
001
002
003
001
002
003
004
001
002
003
001
002
003
001
002
003

Jun
Jun
Jun
Aug
Aug
Aug
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Jan
Jan
Jun
Jun
Jun
Jun

20,
20,
20,
22,
22,
22,
22,
22,
22,
22,
19,
19,
19,
19,
19,
19,
19,
19,
19,
22,
22,
22,
22,
24,
24,
19,
19,
19,
19,

2003

2003

2003

2007

2007

2007

2004

2004

2004

2004

2003

2003

2003

2003

2003

2003

2003

2003

2003

2004

2004

2004

2004

2003

2003

2003

2003

2003

2003

N020415 001 Jun 14, 1996

N020415 002 Jun 14, 1996

N020415 003 Mar 17, 1997

A076307
A076307
A076307
A077376
A077376
A077376
A076901
A076901
A076901

001
002
003
002
003
004
001
002
003

Dec
Dec
Feb
Dec
Dec
Feb
Jun
Jun
Jun

17,
17,
28,
08,
08,
28,
28,
28,
28,

2003

2003

2006

2005

2005

2006

2005

2005

2005

N021208 001 Jan 12, 2001

N021208 002 Jan 12, 2001

N021208 003 Jan 12, 2001

0.1MG
0.2MG

N019268 003 Sep 21, 1990

N019268 001 Dec 27, 1988

0.1MG
0.2MG
0.1MG
0.2MG

A076095
A076095
A091667
A091667

0.2MG/VIAL

N022572 001 Feb 07, 2012

5MG/VIAL
20MG/VIAL
40MG/VIAL
5MG/VIAL

A064144
A064144
A064144
A064117

001
002
001
002

001
002
003
001

Jul
Jul
Jul
Jul

Apr
Apr
Aug
Apr

10,
10,
25,
25,

30,
30,
11,
19,

2002

2002

2012

2012

1998

1998

2009

1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-263(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MITOMYCIN

INJECTABLE;INJECTION

MITOMYCIN

AP
AP
HIKMA MAPLE
AP

20MG/VIAL
5MG/VIAL
20MG/VIAL

A064117 002 Apr 19, 1995

A064180 001 Dec 23, 1999

A064180 002 Dec 23, 1999

MITOTANE

TABLET;ORAL

LYSODREN

+ BRISTOL MYERS SQUIBB

500MG

N016885 001

MITOXANTRONE HYDROCHLORIDE

INJECTABLE;INJECTION

MITOXANTRONE HYDROCHLORIDE

AP
EUROHLTH INTL SARL
AP
AP
AP
FRESENIUS KABI USA
AP
AP
AP
+ HOSPIRA
AP
+
AP
+
AP
MYLAN INSTITUTIONAL
AP
AP
MYLAN LABS LTD
AP
TEVA PHARMS USA
AP
AP

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

MIVACURIUM CHLORIDE

SOLUTION;INTRAVENOUS

MIVACRON

ABBVIE
+

EQ 10MG BASE/5ML (EQ 2MG BASE/ML)

EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

N020098 004 Jan 22, 1992

N020098 005 Jan 22, 1992

100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG

A202700
A202700
A077667
A077667
A202566
A202566
A076715
A076715
A090543
A090543
A076594
A076594
A078963
A078963

100MG
200MG

N020717 001 Dec 24, 1998

N020717 002 Dec 24, 1998

7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG

A078454
A078454
A090416
A090416
A077536
A077536
A076204
A076204

7.5MG
15MG

N020312 001 Apr 19, 1995

N020312 002 Apr 19, 1995

MODAFINIL

TABLET;ORAL

MODAFINIL

AB
ALEMBIC LTD
AB
AB
APOTEX INC
AB
AB
AUROBINDO PHARMA LTD
AB
AB
CARLSBAD
AB
AB
HIKMA PHARMS
AB
AB
MYLAN PHARMS INC
AB
AB
ORCHID HLTHCARE
AB
PROVIGIL

AB
CEPHALON
AB
+
MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL

MOEXIPRIL HYDROCHLORIDE

AB
APOTEX INC
AB
AB
GLENMARK GENERICS
AB
AB
PADDOCK LLC
AB
AB
TEVA
AB
UNIVASC

AB
UCB INC
AB
+

20MG
25MG
30MG
20MG
25MG
30MG
20MG
25MG
30MG
20MG
30MG
20MG
20MG
25MG
30MG

BASE/10ML (EQ 2MG BASE/ML)

BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)

A076611
A076611
A076611
A077496
A077496
A077496
A076871
A076871
A076871
A078980
A078980
A201014
A077356
A077356
A077356

001
002
003
001
002
003
001
002
003
001
002
001
001
002
003

001
002
001
002
001
002
001
002
001
002
001
002
001
002

001
002
001
002
001
002
001
002

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Dec
Apr
Apr
Apr

Oct
Oct
Feb
Feb
Sep
Sep
Nov
Nov
Sep
Sep
Jul
Jul
Sep
Sep

Jun
Jun
Mar
Mar
Nov
Nov
May
May

11,
11,
11,
11,
11,
11,
11,
11,
11,
13,
13,
11,
11,
11,
11,

18,
18,
03,
03,
27,
27,
01,
01,
26,
26,
16,
16,
26,
26,

02,
02,
30,
30,
30,
30,
08,
08,

2006

2006

2006

2006

2006

2006

2006

2006

2006

2009

2009

2012

2006

2006

2006

2012

2012

2014

2014

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2008

2008

2010

2010

2006

2006

2003

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-264(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MOLINDONE HYDROCHLORIDE

TABLET;ORAL

MOLINDONE HYDROCHLORIDE

COREPHARMA
+
MOMETASONE FUROATE

AEROSOL, METERED;INHALATION

ASMANEX HFA

MERCK SHARP DOHME
+
CREAM;TOPICAL

ELOCON

AB
+ MERCK SHARP DOHME
AB
MOMETASONE FUROATE

AB
FOUGERA PHARMS
AB
G AND W LABS
AB
GLENMARK GENERICS
AB
TARO
AB
TOLMAR
LOTION;TOPICAL

ELOCON

AB
+ MERCK SHARP DOHME
MOMETASONE FUROATE

AB
FOUGERA PHARMS
AB
G AND W LABS
AB
GLENMARK GENERICS
AB
PERRIGO
AB
TARO
AB
TOLMAR
OINTMENT;TOPICAL

ELOCON

AB
+ MERCK SHARP DOHME
MOMETASONE FUROATE

AB
FOUGERA PHARMS
AB
G AND W LABS
AB
GLENMARK GENERICS
AB
PERRIGO NEW YORK
AB
TOLMAR
POWDER;INHALATION

ASMANEX TWISTHALER

MERCK SHARP DOHME
+

5MG
10MG
25MG

A090453 001 Mar 20, 2015

A090453 002 Mar 20, 2015

A090453 003 Mar 20, 2015

0.10MG/INH
0.20MG/INH

N205641 001 Apr 25, 2014

N205641 002 Apr 25, 2014

0.1%
0.1%

N019625 001 May 06, 1987

N019625 002 Apr 19, 2013

0.1%
0.1%
0.1%
0.1%
0.1%

A076171
A077447
A078541
A076679
A076591

0.1%

N019796 001 Mar 30, 1989

0.1%
0.1%
0.1%
0.1%
0.1%
0.1%

A075919
A077678
A090506
A077180
A076788
A076499

0.1%

N019543 001 Apr 30, 1987

0.1%
0.1%
0.1%
0.1%
0.1%

A077061
A077401
A078571
A076067
A076481

0.11MG/INH
0.22MG/INH

N021067 002 Feb 01, 2008

N021067 001 Mar 30, 2005

MOMETASONE FUROATE MONOHYDRATE

SPRAY, METERED;NASAL

NASONEX

+ MERCK SHARP DOHME
EQ 0.05MG BASE/SPRAY
MONTELUKAST SODIUM

GRANULE;ORAL

MONTELUKAST SODIUM

AB
AJANTA PHARMA LTD
AB
DR REDDYS LABS LTD
AB
MYLAN PHARMS INC
AB
TEVA PHARMS
SINGULAIR

AB
+ MERCK
TABLET;ORAL

MONTELUKAST SODIUM

AB
ACCORD HLTHCARE
AB
AJANTA PHARMA LTD
AB
AMNEAL PHARMS
AB
ANBISON LAB CO LTD
APOTEX CORP
AB
AB
AUROBINDO PHARMA LTD
AB
DR REDDYS LABS LTD
AB
GLENMARK GENERICS
AB
HETERO LABS LTD V
AB
KREMERS URBAN PHARMS
AB
MACLEODS PHARMS LTD
AB
MYLAN PHARMS INC

EQ
EQ
EQ
EQ

4MG
4MG
4MG
4MG

BASE/PACKET
BASE/PACKET
BASE/PACKET
BASE/PACKET

001
001
001
001
001

001
001
001
001
001
001

001
001
001
001
001

Apr
May
May
Dec
Apr

Nov
Nov
Aug
Apr
Mar
Nov

Mar
Jun
May
Mar
Nov

08,
22,
28,
21,
18,

29,
21,
09,
06,
15,
21,

28,
20,
28,
18,
14,

2005

2006

2008

2004

2007

2007

2007

2010

2005

2006

2007

2005

2006

2008

2002

2003

N020762 001 Oct 01, 1997

A203438
A202906
A202776
A090955

001
001
001
001

Jul
Sep
Dec
Aug

31,
17,
18,
03,

2015

2012

2012

2012

EQ 4MG BASE/PACKET

N021409 001 Jul 26, 2002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A202717
A203432
A204604
A205683
A201294
A202468
A201582
A090926
A202843
A201522
A203366
A079103

10MG
10MG
10MG
10MG
10MG
10MG
10MG
10MG
10MG
10MG
10MG
10MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001
001
001
001
001
001

Sep
Jul
Sep
Jan
Aug
Aug
Aug
Aug
Sep
Aug
Sep
Aug

21,
31,
04,
12,
03,
03,
06,
03,
10,
03,
11,
03,

2012

2015

2015

2016

2012

2012

2012

2012

2014

2012

2014

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-265(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MONTELUKAST SODIUM

TABLET;ORAL

MONTELUKAST SODIUM
AB
ROXANE
AB
SANDOZ INC
AB
TEVA PHARMS
AB
TORRENT PHARMS LTD
AB
UNICHEM LABS LTD
AB
UNIMARK REMEDIES LTD
AB
VINTAGE PHARMS LLC
SINGULAIR
AB
+ MERCK
TABLET, CHEWABLE;ORAL

MONTELUKAST SODIUM

AB
AJANTA PHARMA LTD

AB

AB
ANBISON LAB CO LTD

AB

AB
APOTEX INC

AB

AB
AUROBINDO PHARMA LTD

AB

AB
DR REDDYS LABS LTD

AB

AB
HETERO LABS LTD V

AB

AB
JUBILANT GENERICS

AB

AB
KREMERS URBAN PHARMS

AB

AB
MACLEODS PHARMS LTD

AB

AB
MYLAN PHARMS INC

AB

AB
ROXANE

AB

AB
SANDOZ INC

AB

AB
TEVA PHARMS

AB

AB
TORRENT PHARMS LTD

AB

AB
UNIMARK REMEDIES LTD

AB

AB
VINTAGE PHARMS LLC

AB

SINGULAIR

AB
MERCK

AB
+

EQ
EQ
EQ
EQ
EQ
EQ
EQ

10MG
10MG
10MG
10MG
10MG
10MG
10MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A090655
A200889
A078605
A201515
A204290
A202859
A091576

001
001
001
001
001
001
001

Aug
Aug
Aug
Aug
Oct
Oct
Aug

03,
03,
03,
03,
08,
30,
03,

2012

2012

2012

2012

2015

2014

2012

EQ 10MG BASE

N020829 002 Feb 20, 1998

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A203328
A203328
A205695
A205695
A201508
A201508
A202096
A202096
A201581
A201581
A204093
A204093
A203795
A203795
A200405
A200405
A203582
A203582
A079142
A079142
A091128
A091128
A091414
A091414
A078723
A078723
A090984
A090984
A203037
A203037
A091588
A091588

4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

EQ 4MG BASE

EQ 5MG BASE

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

KADIAN

AB1 + ACTAVIS LABS UT INC
10MG

AB1
20MG
AB1
30MG
AB1
40MG
AB1
50MG
AB1
60MG
AB1
70MG
AB1
80MG
AB1 +
100MG
AB1 +
200MG
MORPHINE SULFATE
AB1
PAR PHARM INC
20MG
AB1
30MG
AB1
50MG
AB1
60MG
AB1
80MG
AB1
100MG
AB1
TEVA PHARMS USA
20MG
AB1
30MG
AB1
40MG

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Jul
Jul
Nov
Nov
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Feb
Feb
Aug
Aug
Mar
Mar
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Aug
Aug

31,
31,
05,
05,
03,
03,
03,
03,
06,
06,
22,
22,
27,
27,
03,
03,
12,
12,
03,
03,
03,
03,
03,
03,
03,
03,
03,
03,
30,
30,
03,
03,

2015

2015

2015

2015

2012

2012

2012

2012

2012

2012

2015

2015

2015

2015

2012

2012

2015

2015

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2014

2014

2012

2012

N020830 002 Mar 03, 2000

N020830 001 Feb 20, 1998

N020616
N020616
N020616
N020616
N020616
N020616
N020616
N020616
N020616
N020616

008
001
004
009
002
005
010
006
003
007

Apr
Jul
Mar
Jul
Jul
Mar
Jul
Oct
Jul
Feb

20,
03,
09,
09,
03,
09,
09,
27,
03,
27,

2007

1996

2001

2012

1996

2001

2012

2006

1996

2007

A200812
A200812
A200812
A200812
A200812
A200812
A202718
A202718
A202718

001
002
003
004
005
006
001
002
007

Nov
Nov
Nov
Nov
Nov
Nov
Dec
Dec
Jun

10,
10,
10,
10,
10,
10,
29,
29,
03,

2011

2011

2011

2011

2011

2011

2014

2014

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-266(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

MORPHINE SULFATE

AB1
50MG
AB1
60MG
AB1
70MG
AB1
80MG
AB1
100MG
AB1
UPSHER SMITH
10MG
AB1
20MG
AB1
30MG
AB1
50MG
AB1
60MG
AB1
80MG
AB1
100MG
KADIAN

ACTAVIS LABS UT INC
130MG
150MG
MORPHINE SULFATE

ACTAVIS ELIZABETH
30MG
45MG
60MG
75MG
90MG
+
120MG
INJECTABLE;INJECTION

ASTRAMORPH PF

AP
FRESENIUS KABI USA
0.5MG/ML
AP
0.5MG/ML
AP
1MG/ML
AP
1MG/ML
DURAMORPH PF

AP
+ EUROHLTH INTL SARL
0.5MG/ML
AP
+
1MG/ML
MORPHINE SULFATE

AP
EUROHLTH INTL SARL
4MG/ML
AP
8MG/ML
AP
10MG/ML
AP
HOSPIRA
0.5MG/ML
AP
0.5MG/ML
AP
1MG/ML
AP
1MG/ML
AP
+
1MG/ML
AP
+ HOSPIRA INC
4MG/ML
AP
+
8MG/ML
AP
+
10MG/ML
INFUMORPH

+ EUROHLTH INTL SARL
10MG/ML
+
25MG/ML
MORPHINE SULFATE

+ HOSPIRA
5MG/ML
+ HOSPIRA INC
2MG/ML
+
15MG/ML
+ MERIDIAN MEDCL TECHN
15MG/ML
SOLUTION;INTRAMUSCULAR, INTRAVENOUS

MORPHINE SULFATE

+ BD RX
2MG/ML (2MG/ML)
+
4MG/ML (4MG/ML)
+
5MG/ML (5MG/ML)
+
8MG/ML (8MG/ML)
+
10MG/ML (10MG/ML)
SOLUTION;ORAL

MORPHINE SULFATE

AA
MALLINCKRODT INC
100MG/5ML
AA
PADDOCK LLC
100MG/5ML
AA
ROXANE
10MG/5ML
AA
20MG/5ML
AA
+
100MG/5ML
AA
SUN PHARM INDS INC
10MG/5ML
AA
20MG/5ML
AA
TRIS PHARMA INC
10MG/5ML
AA
100MG/5ML

A202718
A202718
A202718
A202718
A202718
A202104
A202104
A202104
A202104
A202104
A202104
A202104

003
004
008
005
006
001
002
003
004
005
006
007

Dec
Dec
Jun
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun

29,
29,
03,
29,
29,
03,
03,
03,
03,
03,
03,
03,

2014

2014

2015

2014

2014

2013

2013

2013

2013

2013

2013

2013

N020616 011 Jul 09, 2012

N020616 012 Jul 09, 2012

A079040
A079040
A079040
A079040
A079040
A079040

001
002
003
004
005
006

Jan
Jan
Jan
Jan
Jan
Jan

16,
16,
16,
16,
16,
16,

2013

2013

2013

2013

2013

2013

A071050
A071051
A071052
A071053

001
001
001
001

Oct
Oct
Oct
Oct

07,
07,
07,
07,

1986

1986

1986

1986

N018565 001 Sep 18, 1984

N018565 002 Sep 18, 1984

A205758
A205758
A205758
A071849
A073509
A071850
A073510
N019916
N202515
N202515
N202515

001
002
003
001
001
001
001
001
002
003
004

May
May
May
May
Sep
May
Sep
Oct
Nov
Nov
Nov

21,
21,
21,
11,
30,
11,
30,
30,
14,
14,
14,

2015

2015

2015

1988

1992

1988

1992

1992

2011

2011

2011

N018565 003 Jul 19, 1991

N018565 004 Jul 19, 1991

N019916
N202515
N202515
N019999

002
001
005
001

Oct
Nov
Nov
Jul

27,
14,
14,
12,

2006

2011

2011

1990

N204223
N204223
N204223
N204223
N204223

001
002
003
004
005

Oct
Oct
Oct
Oct
Oct

30,
30,
30,
30,
30,

2013

2013

2013

2013

2013

A202348
A201574
N022195
N022195
N022195
A201011
A201011
A203518
A203518

001
001
001
002
003
001
002
001
002

Jul
Aug
Mar
Mar
Jan
Feb
Feb
May
May

15,
06,
17,
17,
25,
05,
05,
12,
12,

2011

2012

2008

2008

2010

2014

2014

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-267(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MORPHINE SULFATE

SOLUTION;ORAL

MORPHINE SULFATE
AA
VINTAGE PHARMS LLC
10MG/5ML

AA
20MG/5ML

AA
VISTAPHARM
10MG/5ML

AA
20MG/5ML

LANNETT HOLDINGS INC

100MG/5ML

TABLET;ORAL

MORPHINE SULFATE

ROXANE

15MG

+

30MG

TABLET, EXTENDED RELEASE;ORAL

MORPHINE SULFATE

AB
ACTAVIS ELIZABETH

15MG

AB

30MG

AB

60MG

AB

100MG

AB

200MG

AB
DAVA PHARMS INC

15MG

AB
MALLINCKRODT

15MG

AB

30MG

AB

60MG

AB

100MG

AB

200MG

AB
MYLAN PHARMS INC

15MG

AB

30MG

AB

60MG

AB

100MG

AB

200MG

AB
NESHER PHARMS

15MG

AB

30MG

AB

60MG

AB

100MG

AB

200MG

AB
NOVEL LABS INC

15MG

AB

30MG

AB

60MG

AB

100MG

AB

200MG

AB
RHODES PHARMS

15MG

AB

30MG

AB

60MG

AB

100MG

AB

200MG

AB
SUN PHARM INDS LTD

15MG

AB

30MG

AB

60MG

AB

100MG

AB

200MG

AB
VINTAGE PHARMS LLC

15MG

AB

30MG

AB

60MG

AB

100MG

AB

200MG

MS CONTIN

AB
PURDUE PHARMA LP

15MG

AB

30MG

AB

60MG

AB
+

100MG

AB

200MG

MORPHABOND

IDT

15MG

30MG

60MG

+

100MG

A202309
A202310
A201947
A201947
N201517

001
001
001
002
001

Nov
Oct
Jan
Jan
Jun

25,
30,
05,
05,
23,

2015

2015

2012

2012

2011

N022207 001 Mar 17, 2008

N022207 002 Mar 17, 2008

A203849
A203849
A203849
A203849
A203849
A075407
A076412
A076412
A076412
A076438
A076438
A200824
A200824
A200824
A200824
A200824
A076733
A076720
A076720
A077855
A077855
A203602
A203602
A203602
A203602
A203602
A074862
A074862
A074862
A074769
A074769
A078761
A078761
A078761
A078761
A078761
A075295
A075295
A075295
A075295
A075295

001
002
003
004
005
001
001
002
003
001
002
001
002
003
004
005
001
002
001
001
002
001
002
003
004
005
001
002
003
001
002
001
002
003
004
005
001
002
003
004
005

Apr
Apr
Apr
Apr
Apr
Jan
Jul
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Oct
May
Dec
May
Sep
Sep
Dec
Dec
Dec
Dec
Dec
Jul
Jul
Jul
Jul
Jul
May
May
May
May
May
Oct
Oct
Oct
Sep
Sep

06,
06,
06,
06,
06,
28,
31,
31,
31,
03,
03,
18,
18,
18,
18,
18,
19,
23,
19,
27,
27,
16,
16,
16,
16,
16,
07,
07,
07,
02,
02,
11,
11,
11,
11,
11,
28,
28,
28,
15,
15,

2015

2015

2015

2015

2015

2000

2003

2003

2003

2003

2003

2011

2011

2011

2011

2011

2004

2005

2004

2007

2007

2015

2015

2015

2015

2015

1998

1998

1998

1998

1998

2012

2012

2012

2012

2012

1998

1998

1998

2000

2000

N019516
N019516
N019516
N019516
N019516

003
001
002
004
005

Sep
May
Apr
Jan
Nov

12,
29,
08,
16,
08,

1989

1987

1988

1990

1993

N206544
N206544
N206544
N206544

001
002
003
004

Oct
Oct
Oct
Oct

02,
02,
02,
02,

2015

2015

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-268(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

EMBEDA

ALPHARMA PHARMS
20MG;0.8MG
30MG;1.2MG
50MG;2MG
+
60MG;2.4MG
80MG;3.2MG
100MG;4MG
MOXIFLOXACIN HYDROCHLORIDE

SOLUTION;IV (INFUSION)

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

+ BAYER HLTHCARE
400MG/250ML (1.6MG/ML)
MOXIFLOXACIN HYDROCHLORIDE

+ FRESENIUS KABI USA
EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)
SOLUTION/DROPS;OPHTHALMIC

MOXIFLOXACIN HYDROCHLORIDE

AT1
LUPIN LTD
EQ 0.5% BASE
AT1
WATSON LABS INC
EQ 0.5% BASE
VIGAMOX

AT1 + ALCON PHARMS LTD
EQ 0.5% BASE
MOXEZA

AT2 + ALCON PHARMS LTD
EQ 0.5% BASE
MOXIFLOXACIN HYDROCHLORIDE

AT2
LUPIN LTD
EQ 0.5% BASE
TABLET;ORAL

AVELOX

AB
+ BAYER HLTHCARE
EQ 400MG BASE
MOXIFLOXACIN HYDROCHLORIDE

AB
AUROBINDO PHARMA LTD
EQ 400MG BASE
AB
DR REDDYS LABS LTD
EQ 400MG BASE
AB
MYLAN PHARMS INC
EQ 400MG BASE
AB
TEVA PHARMS USA
EQ 400MG BASE
AB
TORRENT PHARMS LTD
EQ 400MG BASE
MUPIROCIN

OINTMENT;TOPICAL

BACTROBAN

AB
+ GLAXOSMITHKLINE
MUPIROCIN

AB
FOUGERA PHARMS
AB
GLENMARK PHARMS
AB
PERRIGO NEW YORK
AB
TARO
AB
TEVA
CENTANY

BX
PERRIGO NEW YORK
MUPIROCIN CALCIUM

CREAM;TOPICAL

BACTROBAN

AB
+ GLAXOSMITHKLINE
MUPIROCIN

AB
GLENMARK GENERICS
OINTMENT;NASAL

BACTROBAN

+ GLAXOSMITHKLINE
MYCOPHENOLATE MOFETIL

CAPSULE;ORAL

CELLCEPT

AB
+ ROCHE PALO
MYCOPHENOLATE MOFETIL

AB
ACCORD HLTHCARE
AB
ALKEM LABS LTD
AB
APOTEX CORP
AB
CADISTA PHARMS
AB
MYLAN
AB
ROXANE
AB
SANDOZ
AB
STRIDES PHARMA
AB
TEVA PHARMS
AB
VINTAGE PHARMS LLC

N022321
N022321
N022321
N022321
N022321
N022321

001
002
003
004
005
006

Aug
Aug
Aug
Aug
Aug
Aug

13,
13,
13,
13,
13,
13,

2009

2009

2009

2009

2009

2009

N021277 001 Nov 30, 2001

N205572 001 Apr 03, 2015

A202867 001 Sep 04, 2014

A202525 001 Mar 06, 2015

N021598 001 Apr 15, 2003

N022428 001 Nov 19, 2010

A204079 001 May 28, 2015

N021085 001 Dec 10, 1999

A202632
A076938
A204635
A077437
A200160

001
001
001
001
001

Mar
Mar
Aug
Feb
Apr

04,
04,
31,
18,
03,

2014

2014

2015

2014

2014

2%

N050591 001 Dec 31, 1987

2%
2%
2%
2%
2%

A065192
A090480
A065123
A065170
A065085

2%

N050788 001 Dec 04, 2002

EQ 2% BASE

N050746 001 Dec 11, 1997

EQ 2% BASE

A201587 001 Jan 24, 2013

EQ 2% BASE

N050703 001 Sep 18, 1995

250MG

N050722 001 May 03, 1995

250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG

A090253
A200197
A090419
A090762
A065520
A065410
A065379
A090055
A065491
A090111

001
001
001
001
001

001
001
001
001
001
001
001
001
001
001

Nov
Jun
Nov
Sep
Nov

May
Jun
Apr
Dec
May
Jul
Oct
Jun
May
Dec

30,
08,
07,
23,
07,

04,
13,
22,
15,
04,
29,
15,
10,
06,
22,

2005

2011

2003

2005

2003

2009

2013

2009

2014

2009

2008

2008

2010

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-269(of 388)

PRESCRIPTION DRUG PRODUCT LIST

MYCOPHENOLATE MOFETIL

SUSPENSION;ORAL

CELLCEPT

AB
+ ROCHE PALO
MYCOPHENOLATE MOFETIL

AB
ALKEM LABS LTD
TABLET;ORAL

CELLCEPT

AB
+ ROCHE PALO
MYCOPHENOLATE MOFETIL

AB
ACCORD HLTHCARE
AB
ALKEM LABS LTD
AB
APOTEX
AB
CADISTA PHARMS
AB
MYLAN
AB
ROXANE
AB
SANDOZ
AB
STRIDES PHARMA
AB
TEVA PHARMS
AB
VINTAGE PHARMS LLC

200MG/ML

N050759 001 Oct 01, 1998

200MG/ML

A203005 001 Nov 14, 2014

500MG

N050723 001 Jun 19, 1997

500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG

A065416
A091249
A090499
A090661
A065521
A065413
A065451
A090456
A065457
A090606

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

INJECTABLE;INJECTION

CELLCEPT

+ ROCHE PALO
500MG/VIAL

001
001
001
001
001
001
001
001
001
001

May
Nov
Apr
Dec
May
Jul
Oct
Jun
May
Jul

04,
04,
22,
15,
04,
29,
15,
10,
04,
16,

2009

2011

2009

2014

2009

2008

2008

2010

2009

2010

N050758 001 Aug 12, 1998

MYCOPHENOLIC ACID

TABLET, DELAYED RELEASE;ORAL

MYCOPHENOLIC ACID

AB
APOTEX INC
AB
AB
MYLAN PHARMS INC
AB
AB
TEVA PHARMS USA
AB
MYFORTIC

AB
NOVARTIS
AB
+

180MG
360MG
180MG
360MG
180MG
360MG

A091558
A091558
A091248
A091248
A202720
A202720

180MG
360MG

N050791 001 Feb 27, 2004

N050791 002 Feb 27, 2004

NABILONE

CAPSULE;ORAL

CESAMET

+ MEDA PHARMS

1MG

N018677 001 Dec 26, 1985

NABUMETONE

TABLET;ORAL

NABUMETONE

AB
APOTEX INC
AB
AB
INVAGEN PHARMS
AB
AB
LUPIN LTD
AB
AB
MYLAN PHARMS INC
AB
AB
PAR PHARM
AB
AB
SANDOZ
AB
AB
TEVA
AB
+
AB
WATSON LABS
AB

500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG

A090427
A090427
A078671
A078671
A090445
A090445
A090516
A090516
A076009
A076009
A075280
A075280
A075189
A075189
A091083
A091083

20MG
40MG
80MG

N018063 005 Oct 28, 1986

N018063 001

N018063 002

20MG
40MG
80MG
20MG

A203455
A203455
A203455
A074229

NADOLOL

TABLET;ORAL

CORGARD

AB
US WORLD MEDS LLC
AB
AB
+
NADOLOL

AB
INVAGEN PHARMS
AB
AB
AB
IVAX SUB TEVA PHARMS

001
002
002
001
001
002

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

001
002
003
001

Aug
Aug
Jan
Jan
Oct
Oct

Dec
Dec
Mar
Mar
Jan
Jan
Jul
Jul
Jan
Jan
Feb
Feb
May
Sep
Jun
Jun

Dec
Dec
Dec
Aug

21,
19,
08,
08,
30,
30,

30,
30,
07,
07,
12,
12,
12,
12,
24,
24,
25,
25,
26,
24,
13,
13,

18,
18,
18,
30,

2012

2014

2014

2014

2014

2014

2011

2011

2008

2008

2011

2011

2010

2010

2003

2003

2002

2002

2000

2001

2011

2011

2015

2015

2015

1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-270(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NADOLOL

TABLET;ORAL

NADOLOL

AB
AB
AB
MYLAN
AB
AB
AB
ORION CORP ORION
AB
AB
SANDOZ
AB
AB

40MG
80MG
20MG
40MG
80MG
40MG
80MG
20MG
40MG
80MG

A074229
A074255
A074172
A074172
A074172
A201893
A201893
A074501
A074501
A074501

NAFARELIN ACETATE

SPRAY, METERED;NASAL

SYNAREL

+ GD SEARLE LLC

EQ 0.2MG BASE/SPRAY

N019886 001 Feb 13, 1990

NAFCILLIN SODIUM

INJECTABLE;INJECTION

NAFCILLIN SODIUM

AP
ANTIBIOTICE
EQ
AP
EQ
AP
AUROBINDO PHARMA LTD
EQ
AP
EQ
AP
EQ
AP
ISTITUTO BIO ITA SPA
EQ
AP
EQ
AP
EQ
AP
MYLAN LABS LTD
EQ
AP
EQ
AP
SAGENT PHARMS
EQ
AP
EQ
AP
EQ
AP
+ SANDOZ
EQ
AP
+
EQ
AP
+
EQ
AP
+
EQ
AP
+
EQ
NALLPEN IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
EQ
+
EQ
NAFTIFINE HYDROCHLORIDE

CREAM;TOPICAL

NAFTIFINE HYDROCHLORIDE

AB
TARO
NAFTIN

AB
+ MERZ PHARMS
+
GEL;TOPICAL

NAFTIN

+ MERZ PHARMS
+

002
001
001
002
003
001
002
001
002
003

001
002
001
002
001
001
002
001
001
002
001
002
001
002
001
003
002
004

Aug
Jan
Oct
Oct
Oct
Sep
Sep
Nov
Nov
Nov

30,
24,
31,
31,
31,
16,
16,
09,
09,
09,

1996

1996

1993

1993

1993

2015

2015

1995

1995

1995

1GM BASE/VIAL
2GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

A090560
A090560
A091613
A091613
A091614
A090002
A090002
A090005
A200002
A200002
A090582
A090582
A090580
A062527
A062732
A062527
A062732
A062527

20MG BASE/ML
2GM BASE/100ML

N050655 001 Oct 31, 1989

N050655 002 Oct 31, 1989

Oct
Oct
Dec
Dec
Dec
Jun
Jun
Apr
Apr
Apr
Aug
Aug
Aug
Aug
Dec
Aug
Dec
Aug

03,
03,
26,
26,
26,
30,
30,
20,
07,
07,
24,
24,
24,
02,
23,
02,
23,
02,

2011

2011

2012

2012

2012

2011

2011

2011

2014

2014

2012

2012

2012

1984

1986

1984

1986

1984

2%

A206901 001 Jan 06, 2016

2%
1%

N019599 002 Jan 13, 2012

N019599 001 Feb 29, 1988

1%
2%

N019356 001 Jun 18, 1990

N204286 001 Jun 27, 2013

NALBUPHINE HYDROCHLORIDE

INJECTABLE;INJECTION

NALBUPHINE HYDROCHLORIDE

AP
+ HOSPIRA
AP
+
AP
+
AP
+

10MG/ML
10MG/ML
20MG/ML
20MG/ML

A070914
A070915
A070916
A070918

NALOXEGOL OXALATE

TABLET;ORAL

MOVANTIK

ASTRAZENECA PHARMS
+

EQ 12.5MG BASE
EQ 25MG BASE

N204760 001 Sep 16, 2014

N204760 002 Sep 16, 2014

001
001
001
001

Feb
Feb
Feb
Feb

03,
03,
03,
03,

1989

1989

1989

1989

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-271(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NALOXONE HYDROCHLORIDE

INJECTABLE;INJECTION

NALOXONE

AP
EUROHLTH INTL SARL
0.4MG/ML
NALOXONE HYDROCHLORIDE

AP
+ HOSPIRA
0.4MG/ML
AP
+
0.4MG/ML
AP
+
0.4MG/ML
AP
+
0.4MG/ML
AP
INTL MEDICATION
0.4MG/ML
AP
+
1MG/ML
AP
MYLAN INSTITUTIONAL
0.4MG/ML
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

EVZIO

+ KALEO INC
0.4MG/0.4ML
SPRAY, METERED;NASAL

NARCAN

+ ADAPT PHARMA
4MG/SPRAY

N208411 001 Nov 18, 2015

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

AB
GAVIS PHARMS
EQ 0.5MG BASE;EQ 50MG BASE
AB
SUN PHARM INDS LTD
EQ 0.5MG BASE;EQ 50MG BASE
AB
+ WATSON LABS
EQ 0.5MG BASE;EQ 50MG BASE

A075735 001 Jul 11, 2001

A075523 001 Mar 17, 2000

A074736 001 Jan 21, 1997

NALTREXONE

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

VIVITROL

+ ALKERMES
380MG/VIAL

N021897 001 Apr 13, 2006

NALTREXONE HYDROCHLORIDE

TABLET;ORAL

NALTREXONE HYDROCHLORIDE

AB
ACCORD HLTHCARE
AB
BARR
AB
ELITE LABS
AB
MALLINCKRODT
AB
SUN PHARMA GLOBAL
REVIA

AB
+ TEVA WOMENS
NALTREXONE HYDROCHLORIDE

MALLINCKRODT

A070299 001 Sep 24, 1986

A070172
A070254
A070256
A070257
A070639
A072076
A204997

001
001
001
001
001
001
001

Sep
Jan
Jan
Jan
Sep
Mar
Mar

24,
07,
07,
07,
24,
24,
06,

1986

1987

1987

1987

1986

1988

2014

N205787 001 Apr 03, 2014

50MG
50MG
50MG
50MG
50MG

A091205
A074918
A075274
A076264
A090356

50MG

N018932 001 Nov 20, 1984

25MG
100MG

A076264 001 Mar 22, 2002

A076264 003 Mar 22, 2002

NANDROLONE DECANOATE

INJECTABLE;INJECTION

NANDROLONE DECANOATE

+ PHARMAFORCE

200MG/ML

A091252 001 Aug 30, 2010

NAPHAZOLINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

NAPHAZOLINE HYDROCHLORIDE

+ AKORN INC

0.1%

A083590 001

25MG/ML

N018965 001 Mar 23, 1987

25MG/ML

A074190 001 Mar 30, 1994

250MG
375MG
500MG

N017581 002

N017581 003

N017581 004 Apr 15, 1982

250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG

A075927
A075927
A075927
A200429
A200429
A200429
A078250
A078250

NAPROXEN

SUSPENSION;ORAL

NAPROSYN

AB
+ PEDIAPHARM INC
NAPROXEN

AB
ROXANE
TABLET;ORAL

NAPROSYN

AB
ROCHE PALO
AB
AB
+
NAPROXEN

AB
AMNEAL PHARMS NY
AB
AB
AB
AUROBINDO PHARMA USA
AB
AB
AB
GLENMARK GENERICS
AB

001
001
001
002
001

001
002
003
001
002
003
001
002

Aug
May
May
Mar
Feb

Dec
Dec
Dec
Nov
Nov
Nov
Mar
Mar

17,
08,
26,
22,
24,

18,
18,
18,
08,
08,
08,
28,
28,

2011

1998

1999

2002

2012

2001

2001

2001

2011

2011

2011

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-272(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NAPROXEN

TABLET;ORAL

NAPROXEN

AB

AB
HIKMA INTL PHARMS

AB

AB

AB
INVAGEN PHARMS

AB

AB

AB
MARKSANS PHARMA

AB

AB

AB
MYLAN

AB

AB

AB
PERRIGO R AND D

AB

AB

AB
SANDOZ

AB

AB

AB
TEVA

AB

AB

AB
ZYDUS PHARMS USA

AB

AB

TABLET, DELAYED RELEASE;ORAL

EC-NAPROSYN

AB
+ ROCHE PALO

AB
+

NAPROXEN

AB
INVAGEN PHARMS

AB

AB
MYLAN PHARMS INC

AB

AB
PLIVA

AB

AB
SANDOZ

AB

AB
TEVA

AB

500MG

250MG

375MG

500MG

250MG

375MG

500MG

250MG

375MG

500MG

250MG

375MG

500MG

250MG

375MG

500MG

250MG

375MG

500MG

250MG

375MG

500MG

250MG

375MG

500MG

A078250
A076494
A076494
A076494
A091305
A091305
A091305
A091416
A091416
A091416
A074121
A074121
A074121
A077339
A077339
A077339
A074140
A074140
A074140
A074201
A074201
A074201
A078620
A078620
A078620

375MG

500MG

N020067 002 Oct 14, 1994

N020067 003 Oct 14, 1994

375MG

500MG

375MG

500MG

375MG

500MG

375MG

500MG

375MG

500MG

A091432
A091432
A075390
A075390
A075337
A075337
A075061
A075061
A075227
A075227

NAPROXEN SODIUM

TABLET;ORAL

ANAPROX

AB
HOFFMANN LA ROCHE

EQ
ANAPROX DS

AB
+ HOFFMANN LA ROCHE

EQ
NAPROXEN SODIUM

AB
AMNEAL PHARMS NY

EQ
AB

EQ
AB
AUROBINDO PHARMA LTD
EQ
AB

EQ
AB
DR REDDYS LABS LTD

EQ
AB

EQ
AB
GLENMARK GENERICS

EQ
AB

EQ
AB
HIKMA

EQ
AB

EQ
AB
TEVA

EQ
AB

EQ
TABLET, EXTENDED RELEASE;ORAL

NAPRELAN

AB
ALVOGEN MALTA

EQ
AB

EQ
NAPROXEN SODIUM

AB
ACTAVIS LABS FL INC

EQ
AB

EQ
NAPRELAN

+ ALVOGEN MALTA

EQ

003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

001
002
001
002
001
002
001
002
001
002

Mar
Jan
Jan
Jan
Aug
Aug
Aug
Feb
Feb
Feb
Dec
Dec
Dec
Apr
Apr
Apr
Dec
Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun

Sep
Sep
Apr
Apr
May
May
Feb
Feb
Jun
Jun

28,
14,
14,
14,
24,
24,
24,
14,
14,
14,
21,
21,
21,
27,
27,
27,
21,
21,
21,
21,
21,
21,
07,
07,
07,

19,
19,
19,
19,
26,
26,
18,
18,
30,
30,

2007

2004

2004

2004

2011

2011

2011

2011

2011

2011

1993

1993

1993

2005

2005

2005

1993

1993

1993

1993

1993

1993

2007

2007

2007

2011

2011

2001

2001

1999

1999

1998

1998

1998

1998

250MG BASE

N018164 001

500MG BASE

N018164 003 Sep 30, 1987

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A078432
A078432
A200629
A200629
A078486
A078486
A078314
A078314
A074480
A074480
A074198
A074198

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

001
002
001
002
001
002
001
002
002
001
001
002

Apr
Apr
Oct
Oct
Jul
Jul
Apr
Apr
Feb
May
Dec
Dec

25,
25,
31,
31,
26,
26,
27,
27,
18,
14,
21,
21,

2007

2007

2011

2011

2007

2007

2007

2007

1998

1996

1993

1993

375MG BASE

500MG BASE

N020353 001 Jan 05, 1996

N020353 002 Jan 05, 1996

375MG BASE

500MG BASE

A075416 002 Apr 23, 2003

A075416 001 Aug 27, 2002

750MG BASE

N020353 003 Jan 05, 1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-273(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

TABLET;ORAL

TREXIMET

PERNIX IRELAND LTD

60MG;EQ 10MG BASE

+

500MG;EQ 85MG BASE

NARATRIPTAN HYDROCHLORIDE

TABLET;ORAL

AMERGE
AB
GLAXOSMITHKLINE LLC
AB
+
NARATRIPTAN
AB
APOTEX CORP
AB
AB
HERITAGE PHARMS INC
AB
AB
MYLAN PHARMS INC
AB
AB
ORCHID HLTHCARE
AB
AB
PADDOCK LLC
AB
AB
ROXANE
AB
AB
SANDOZ
AB
AB
SUN PHARM INDS LTD
AB
TEVA PHARMS
AB
NATAMYCIN

SUSPENSION;OPHTHALMIC

NATACYN

+ ALCON

NATEGLINIDE

TABLET;ORAL

NATEGLINIDE

AB
ALVOGEN MALTA

AB

AB
DR REDDYS LABS LTD

AB

AB
PAR PHARM

AB

AB
WATSON LABS

AB

STARLIX

AB
NOVARTIS

AB
+

NEBIVOLOL HYDROCHLORIDE

TABLET;ORAL

BYSTOLIC

FOREST LABS

+

NEDOCROMIL SODIUM

SOLUTION/DROPS;OPHTHALMIC

ALOCRIL

AT
+ ALLERGAN

NEDOCROMIL SODIUM

AT
AKORN

NEFAZODONE HYDROCHLORIDE

TABLET;ORAL

NEFAZODONE HYDROCHLORIDE

AB
SUN PHARM INDS LTD

AB

AB

AB

AB

AB
TEVA

AB

N021926 002 May 14, 2015

N021926 001 Apr 15, 2008

EQ 1MG BASE

EQ 2.5MG BASE

N020763 002 Feb 10, 1998

N020763 001 Feb 10, 1998

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A091373
A091373
A200502
A200502
A202431
A202431
A091441
A091441
A091326
A091326
A090381
A090381
A090288
A090288
A091552
A078751
A078751

1MG BASE

2.5MG BASE

1MG BASE

2.5MG BASE

1MG BASE

2.5MG BASE

1MG BASE

2.5MG BASE

1MG BASE

2.5MG BASE

1MG BASE

2.5MG BASE

1MG BASE

2.5MG BASE

2.5MG BASE

1MG BASE

2.5MG BASE

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
002

Apr
Apr
Feb
Feb
May
May
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Feb
Jul
Jul

22,
22,
28,
28,
31,
31,
30,
30,
08,
08,
07,
07,
07,
07,
14,
07,
07,

2011

2011

2011

2011

2012

2012

2012

2012

2010

2010

2010

2010

2010

2010

2011

2010

2010

Dec
Dec
Sep
Sep
Sep
Sep
Mar
Mar

11,
11,
09,
09,
09,
09,
30,
30,

2015

2015

2009

2009

2009

2009

2011

2011

5%

N050514 001

60MG

120MG

60MG

120MG

60MG

120MG

60MG

120MG

A205055
A205055
A077461
A077461
A077463
A077463
A077462
A077462

60MG

120MG

N021204 001 Dec 22, 2000

N021204 002 Dec 22, 2000

EQ
EQ
EQ
EQ

N021742
N021742
N021742
N021742

2.5MG BASE

5MG BASE

10MG BASE

20MG BASE

001
002
001
002
001
002
001
002

002
003
004
005

Dec
Dec
Dec
Oct

17,
17,
17,
08,

2007

2007

2007

2008

2%

N021009 001 Dec 08, 1999

2%

A090638 001 Aug 22, 2012

50MG

100MG

150MG

200MG

250MG

50MG

100MG

A076409
A076409
A076409
A076409
A076409
A076037
A076037

001
002
003
004
005
001
002

Sep
Sep
Sep
Sep
Sep
Sep
Sep

16,
16,
16,
16,
16,
16,
16,

2003

2003

2003

2003

2003

2003

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-274(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NEFAZODONE HYDROCHLORIDE

TABLET;ORAL

NEFAZODONE HYDROCHLORIDE

AB
AB
AB
+
BX
DR REDDYS LABS INC
BX
BX
BX
BX

150MG
200MG
250MG
50MG
100MG
150MG
200MG
250MG

A076037
A076037
A076037
A076309
A076309
A076309
A076309
A076309

NELARABINE

INJECTABLE;IV (INFUSION)

ARRANON

+ NOVARTIS PHARMS CORP

250MG/50ML (5MG/ML)

N021877 001 Oct 28, 2005

NELFINAVIR MESYLATE

TABLET;ORAL

VIRACEPT

+ AGOURON
+

EQ 250MG BASE
EQ 625MG BASE

N020779 001 Mar 14, 1997

N021503 001 Apr 30, 2003

EQ 87.5MG BASE/5ML

A065010 001 May 23, 2002

500MG
500MG
500MG

A065468 001 Mar 29, 2010

A060304 001

A065220 001 Jul 28, 2006

NEOMYCIN SULFATE

SOLUTION;ORAL

NEO-FRADIN

+ X GEN PHARMS
TABLET;ORAL

NEOMYCIN SULFATE

AA
OMAN PHARM PRODUCTS
AA
+ TEVA
AA
X GEN PHARMS

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION;IRRIGATION

NEOMYCIN AND POLYMYXIN B SULFATE

AT
WATSON LABS
EQ 40MG
AT
X GEN PHARMS
EQ 40MG
AT
EQ 40MG
NEOSPORIN G.U. IRRIGANT

AT
+ MONARCH PHARMS
EQ 40MG
NEOSTIGMINE METHYLSULFATE

SOLUTION;INTRAVENOUS

BLOXIVERZ

AP
+ ECLAT PHARMS LLC
AP
+
NEOSTIGMINE METHYLSULFATE

AP
EUROHLTH INTL SARL
AP
FRESENIUS KABI USA
NEPAFENAC

SUSPENSION/DROPS;OPHTHALMIC

ILEVRO

+ ALCON RES LTD
NEVANAC

+ ALCON PHARMS LTD
NESIRITIDE RECOMBINANT

FOR SOLUTION;INTRAVENOUS

NATRECOR

+ SCIOS LLC

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

16,
16,
16,
16,
16,
16,
16,
16,

2003

2003

2003

2003

2003

2003

2003

2003

BASE/ML;200,000 UNITS/ML
BASE/ML;200,000 UNITS/ML
BASE/ML;200,000 UNITS/ML

A062664 001 Apr 08, 1986

A065106 001 Jan 31, 2006

A065108 001 Jan 31, 2006

BASE/ML;200,000 UNITS/ML

A060707 001

5MG/10ML (0.5MG/ML)
10MG/10ML (1MG/ML)

N204078 001 May 31, 2013

N204078 002 May 31, 2013

5MG/10ML (0.5MG/ML)
10MG/10ML (1MG/ML)
5MG/10ML (0.5MG/ML)
10MG/10ML (1MG/ML)

A207042
A207042
N203629
N203629

0.3%

N203491 001 Oct 16, 2012

0.1%

N021862 001 Aug 19, 2005

1.5MG/VIAL

N020920 001 Aug 10, 2001

NETUPITANT; PALONOSETRON HYDROCHLORIDE

CAPSULE;ORAL

AKYNZEO

+ HELSINN HLTHCARE
300MG;EQ 0.5MG BASE
NEVIRAPINE

SUSPENSION;ORAL

NEVIRAPINE

AA
AUROBINDO
VIRAMUNE

AA
+ BOEHRINGER INGELHEIM

003
004
005
001
002
003
004
005

001
002
001
002

Dec
Dec
Jan
Jan

28,
28,
08,
08,

2015

2015

2015

2015

N205718 001 Oct 10, 2014

50MG/5ML

A077702 001 May 22, 2012

50MG/5ML

N020933 001 Sep 11, 1998

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-275(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NEVIRAPINE

TABLET;ORAL

NEVIRAPINE

AB
APOTEX INC
200MG
AB
AUROBINDO
200MG
AB
CIPLA
200MG
AB
HETERO LABS LTD III
200MG
AB
MICRO LABS LTD
200MG
AB
MYLAN LABS
200MG
AB
MYLAN PHARMS INC
200MG
AB
PRINSTON INC
200MG
AB
SCIEGEN PHARMS INC
200MG
AB
STRIDES PHARMA
200MG
VIRAMUNE

AB
+ BOEHRINGER INGELHEIM
200MG
TABLET, EXTENDED RELEASE;ORAL

NEVIRAPINE

AB
ALVOGEN MALTA
100MG
AB
400MG
AB
APOTEX INC
400MG
AB
CIPLA LTD
400MG
AB
MYLAN PHARMS INC
100MG
AB
400MG
AB
SANDOZ INC
400MG
VIRAMUNE XR

AB
BOEHRINGER INGELHEIM
100MG
AB
+
400MG

A203021
A077521
A077956
A078584
A203080
A078864
A202523
A078644
A203176
A078195

001
001
001
001
001
001
001
001
001
001

May
May
May
May
May
May
May
May
May
May

22,
22,
22,
22,
22,
22,
22,
22,
22,
22,

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

N020636 001 Jun 21, 1996

A204621
A204621
A205258
A206448
A206271
A205651
A203411

002
001
001
001
001
001
001

Nov
Jul
Apr
Oct
Nov
Oct
Apr

09,
10,
03,
15,
09,
27,
03,

2015

2015

2014

2015

2015

2014

2014

N201152 002 Nov 08, 2012

N201152 001 Mar 25, 2011

NIACIN

TABLET;ORAL

NIACIN

AA
WOCKHARDT
500MG
NIACOR

AA
+ UPSHER SMITH
500MG
TABLET, EXTENDED RELEASE;ORAL

NIACIN

AB
AMNEAL PHARMS
500MG
AB
750MG
AB
1GM
AB
BARR
500MG
AB
750MG
AB
1GM
AB
LUPIN LTD
500MG
AB
750MG
AB
1GM
AB
SUN PHARMA GLOBAL
500MG
AB
750MG
AB
1GM
NIASPAN

AB
ABBVIE
500MG
AB
+
750MG
AB
+
1GM

N020381 002 Jul 28, 1997

N020381 003 Jul 28, 1997

N020381 004 Jul 28, 1997

NIACIN; SIMVASTATIN

TABLET, EXTENDED RELEASE;ORAL

SIMCOR

+ ABBVIE
500MG;20MG
+
500MG;40MG
+
750MG;20MG
+
1GM;20MG
+
1GM;40MG

N022078
N022078
N022078
N022078
N022078

NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL

CARDENE

AB
CHIESI USA INC
AB
+
NICARDIPINE HYDROCHLORIDE

AB
ANI PHARMS INC
AB
AB
AB
AB
EPIC PHARMA
AB

A081134 001 Apr 28, 1992

A040378 001 May 03, 2000

A203578
A204178
A203578
A076378
A076378
A076250
A090860
A090892
A090446
A200484
A201273
A200484

001
001
002
001
002
001
001
001
001
001
001
002

001
004
002
003
005

Jul
Dec
Jul
Apr
Apr
Apr
Mar
Mar
Mar
Apr
Apr
Apr

Feb
Jul
Feb
Feb
Jul

24,
11,
24,
26,
26,
14,
20,
20,
20,
23,
23,
23,

15,
28,
15,
15,
28,

2015

2015

2015

2005

2005

2005

2014

2014

2014

2014

2014

2014

2008

2010

2008

2008

2010

20MG
30MG

N019488 001 Dec 21, 1988

N019488 002 Dec 21, 1988

20MG
20MG
30MG
30MG
20MG
30MG

A074439
A074540
A074439
A074540
A074928
A074928

001
001
002
002
001
002

Dec
Oct
Dec
Oct
Mar
Mar

10,
28,
10,
28,
19,
19,

1996

1996

1996

1996

1998

1998

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-276(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL

NICARDIPINE HYDROCHLORIDE

AB
MYLAN
20MG
AB
30MG
INJECTABLE;INJECTION

CARDENE

AP
+ CHIESI USA INC
25MG/10ML (2.5MG/ML)
NICARDIPINE HYDROCHLORIDE

AP
BEDFORD
25MG/10ML (2.5MG/ML)
AP
EXELA PHARMA SCIENCE
25MG/10ML (2.5MG/ML)
AP
LUITPOLD
25MG/10ML (2.5MG/ML)
AP
MYLAN INSTITUTIONAL
25MG/10ML (2.5MG/ML)
AP
NAVINTA LLC
25MG/10ML (2.5MG/ML)
AP
SUN PHARMA GLOBAL
25MG/10ML (2.5MG/ML)
AP
WOCKHARDT
25MG/10ML (2.5MG/ML)
INJECTABLE;INTRAVENOUS

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

+ CHIESI USA INC
40MG/200ML (0.2MG/ML)
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

+ CHIESI USA INC
20MG/200ML (0.1MG/ML)
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

+ CHIESI USA INC
20MG/200ML (0.1MG/ML)
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

+ CHIESI USA INC
40MG/200ML (0.2MG/ML)

A078714
N022276
A090534
A090664
A090125
N078405
A090671

NICOTINE

INHALANT;ORAL

NICOTROL

+ PHARMACIA AND UPJOHN
SPRAY, METERED;NASAL

NICOTROL

+ PFIZER INC

4MG/CARTRIDGE

N020714 001 May 02, 1997

0.5MG/SPRAY

N020385 001 Mar 22, 1996

NIFEDIPINE

CAPSULE;ORAL

NIFEDIPINE

AB
ACTAVIS ELIZABETH
10MG
AB
20MG
AB
HERITAGE PHARMA
10MG
AB
20MG
AB
INTERGEL PHARM
10MG
PROCARDIA

AB
+ PFIZER
10MG
TABLET, EXTENDED RELEASE;ORAL

ADALAT CC

AB1
BAYER HLTHCARE
30MG
AB1 +
60MG
AB1 +
90MG
AFEDITAB CR

AB1
WATSON LABS
30MG
AB1
60MG
NIFEDIPINE

AB1
MYLAN
30MG
AB1
60MG
AB1
90MG
AB1
PAR PHARM
30MG
AB1
60MG
AB1
90MG
AB1
VALEANT INTL
30MG
AB1
60MG
AB1
90MG
AB2
MATRIX LABS LTD
30MG
AB2
60MG
AB2
90MG
AB2
MYLAN
30MG
AB2
60MG
AB2
90MG
AB2
OSMOTICA PHARM
30MG
AB2
60MG
AB2
90MG
AB2
TWI PHARMS INC
30MG
AB2
60MG

A074642 001 Jul 18, 1996

A074642 002 Jul 18, 1996

N019734 001 Jan 30, 1992

001
001
001
001
001
001
001

Dec
Jul
Nov
Nov
Nov
Nov
Nov

28,
24,
17,
17,
17,
17,
17,

2009

2008

2009

2009

2009

2009

2009

N019734 004 Nov 07, 2008

N019734 003 Jul 31, 2008

N019734 002 Jul 31, 2008

N019734 005 Nov 07, 2008

A072579
A072556
A202644
A202644
A072781

001
001
001
002
001

Jan
Sep
Apr
Apr
Jul

08,
20,
25,
25,
30,

1991

1990

2013

2013

1993

N018482 001

N020198 001 Apr 21, 1993

N020198 002 Apr 21, 1993

N020198 003 Apr 21, 1993

A075128 001 Mar 10, 2000

A075659 001 Oct 26, 2001

A201071
A201071
A201071
A077899
A077899
A077899
A075269
A075269
A076070
A090602
A090602
A090602
A090649
A090649
A090649
A077127
A077127
A077410
A203126
A203126

001
002
003
001
002
003
001
002
001
001
002
003
001
002
003
001
002
001
001
002

Dec
Dec
Dec
Dec
Dec
May
Dec
Dec
Aug
Sep
Sep
Sep
Jun
Jun
Jun
Nov
Nov
Oct
Apr
Apr

03,
03,
03,
13,
13,
25,
04,
04,
16,
13,
13,
13,
21,
21,
21,
21,
21,
03,
03,
03,

2010

2010

2010

2006

2006

2012

2000

2000

2002

2010

2010

2010

2010

2010

2010

2005

2005

2007

2014

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-277(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NIFEDIPINE

TABLET, EXTENDED RELEASE;ORAL

NIFEDIPINE

AB2

90MG

AB2
VALEANT PHARMS NORTH
30MG

AB2

60MG

PROCARDIA XL

AB2
PFIZER

30MG

AB2

60MG

AB2 +

90MG

A203126 003 Apr 03, 2014

A075289 002 Feb 06, 2001

A075289 001 Sep 27, 2000

N019684 001 Sep 06, 1989

N019684 002 Sep 06, 1989

N019684 003 Sep 06, 1989

NILOTINIB HYDROCHLORIDE MONOHYDRATE

CAPSULE;ORAL

TASIGNA

NOVARTIS

EQ 150MG BASE

+

EQ 200MG BASE

N022068 002 Jun 17, 2010

N022068 001 Oct 29, 2007

NILUTAMIDE

TABLET;ORAL

NILANDRON

+ CONCORDIA PHARMS INC

150MG

N020169 002 Apr 30, 1999

30MG

30MG

30MG

30MG

30MG

A076740
A077811
A201832
A077067
A090103

60MG/20ML

N203340 001 May 10, 2013

EQ 100MG BASE

EQ 150MG BASE

N205832 001 Oct 15, 2014

N205832 002 Oct 15, 2014

NIMODIPINE

CAPSULE;ORAL

NIMODIPINE

AB
+ BANNER LIFE SCIENCES
AB
BARR LABS INC
AB
SOFGEN PHARMS
AB
SUN PHARM INDS INC
AB
THEPHARMANETWORK LLC
SOLUTION;ORAL

NYMALIZE

+ ARBOR PHARMS LLC

NINTEDANIB ESYLATE

CAPSULE;ORAL

OFEV

BOEHRINGER INGELHEIM

+

NISOLDIPINE

TABLET, EXTENDED RELEASE;ORAL

NISOLDIPINE

AB
MYLAN

8.5MG

AB

17MG

AB

34MG

SULAR

AB
+ SHIONOGI INC

8.5MG

AB
+

17MG

AB
+

34MG

NISOLDIPINE

MYLAN

20MG

25.5MG

+

30MG

+

40MG

NITAZOXANIDE

FOR SUSPENSION;ORAL

ALINIA

+ ROMARK

TABLET;ORAL

ALINIA

+ ROMARK

NITISINONE

CAPSULE;ORAL

ORFADIN

SWEDISH ORPHAN

+

001
001
001
001
001

Jan
May
Jul
Apr
Apr

17,
02,
24,
17,
07,

2008

2007

2015

2007

2014

A091001 001 Jan 26, 2011

A091001 002 Jan 26, 2011

A091001 004 Jan 26, 2011

N020356 008 Jan 02, 2008

N020356 007 Jan 02, 2008

N020356 005 Jan 02, 2008

A079051
A091001
A079051
A079051

001
003
002
003

Jul
Jan
Jul
Jul

25,
26,
25,
25,

2008

2011

2008

2008

100MG/5ML

N021498 001 Nov 22, 2002

500MG

N021497 001 Jul 21, 2004

2MG

5MG

10MG

N021232 001 Jan 18, 2002

N021232 002 Jan 18, 2002

N021232 003 Jan 18, 2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-278(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NITRIC OXIDE

GAS;INHALATION

INOMAX

+ INO
NITROFURANTOIN

SUSPENSION;ORAL

FURADANTIN

AB
+ SHIONOGI INC
NITROFURANTOIN

AB
AMNEAL PHARMS
AB
NOVEL LABS INC
AB
SUN PHARM INDS INC

800PPM

N020845 003 Dec 23, 1999

25MG/5ML

N009175 001

25MG/5ML
25MG/5ML
25MG/5ML

A201679 001 May 11, 2011

A201693 001 Sep 08, 2014

A201355 001 Aug 14, 2013

NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

MACRODANTIN

AB
ALVOGEN MALTA
25MG
AB
50MG
AB
+
100MG
NITROFURANTOIN

AB
ACTAVIS LABS FL INC
25MG
AB
50MG
AB
100MG
AB
IVAX SUB TEVA PHARMS
50MG
AB
100MG
AB
MYLAN
50MG
AB
100MG
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

MACROBID

AB
+ ALVOGEN INC
75MG;25MG
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

AB
MYLAN
75MG;25MG
AB
SANDOZ
75MG;25MG
AB
WATSON LABS INC
75MG;25MG
NITROGLYCERIN

AEROSOL, METERED;SUBLINGUAL

NITROMIST

+ MIST PHARMS LLC
0.4MG/SPRAY
FILM, EXTENDED RELEASE;TRANSDERMAL

MINITRAN

AB1
MEDICIS
0.2MG/HR
AB1
0.4MG/HR
AB1
VALEANT PHARMS
0.1MG/HR
AB1
0.6MG/HR
NITRO-DUR

AB1 + MERCK SHARP DOHME
0.1MG/HR
AB1 +
0.2MG/HR
AB1 +
0.4MG/HR
AB1 +
0.6MG/HR
NITROGLYCERIN

AB2
HERCON PHARM
0.2MG/HR
AB2
0.4MG/HR
AB2
0.6MG/HR
AB2 + MYLAN TECHNOLOGIES
0.2MG/HR
AB2 +
0.4MG/HR
AB2 +
0.6MG/HR
NITRO-DUR

+ MERCK SHARP DOHME
0.3MG/HR
+
0.8MG/HR
NITROGLYCERIN

+ MYLAN TECHNOLOGIES
0.1MG/HR
INJECTABLE;INJECTION

NITROGLYCERIN IN DEXTROSE 5%

AP
+ BAXTER HLTHCARE
10MG/100ML
AP
+
20MG/100ML
AP
+
40MG/100ML
AP
HOSPIRA
10MG/100ML
AP
20MG/100ML
AP
40MG/100ML

N016620 003

N016620 001

N016620 002

A091095
A091095
A091095
A073671
A073652
A074967
A077025

001
002
003
001
001
001
001

Jun
Jun
Jun
Jan
Jan
Jul
Aug

18,
18,
18,
28,
28,
09,
18,

2015

2015

2015

1993

1993

1997

2004

N020064 001 Dec 24, 1991

A076648 001 Mar 22, 2004

A077066 001 Apr 05, 2005

A202250 001 Jul 08, 2015

N021780 001 Nov 02, 2006

A089772
A089773
A089771
A089774

001
001
001
001

Aug
Aug
Aug
Aug

30,
30,
30,
30,

1996

1996

1996

1996

N020145
N020145
N020145
N020145

001
002
004
005

Apr
Apr
Apr
Apr

04,
04,
04,
04,

1995

1995

1995

1995

A089884
A089885
A089886
A074559
A074559
A074559

001
001
001
003
002
001

Oct
Oct
Oct
Aug
Aug
Aug

30,
30,
30,
30,
30,
30,

1998

1998

1998

1996

1996

1996

N020145 003 Apr 04, 1995

N020145 006 Apr 04, 1995

A074559 004 Feb 06, 1998

N019970
N019970
N019970
A071846
A071847
A071848

001
002
003
001
001
001

Dec
Dec
Dec
Aug
Aug
Aug

29,
29,
29,
31,
31,
31,

1989

1989

1989

1990

1990

1990

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-279(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NITROGLYCERIN

INJECTABLE;INJECTION

NITROGLYCERIN

+ LUITPOLD
OINTMENT;INTRA-ANAL

RECTIV

+ FOREST LABS INC
OINTMENT;TRANSDERMAL

NITROGLYCERIN

+ FOUGERA
SPRAY, METERED;SUBLINGUAL

NITROGLYCERIN

AB
PERRIGO ISRAEL
NITROLINGUAL PUMPSPRAY

AB
+ POHL BOSKAMP
TABLET;SUBLINGUAL

NITROSTAT

PFIZER PHARMS
+
NIZATIDINE

CAPSULE;ORAL

NIZATIDINE

AB
ANI PHARMS INC
AB
AB
DR REDDYS LABS LTD
AB
AB
GLENMARK GENERICS
AB
AB
MYLAN PHARMS INC
AB
+
AB
SANDOZ
AB
AB
WATSON LABS
AB
SOLUTION;ORAL

AXID

AA
+ BRAINTREE
NIZATIDINE

AA
AMNEAL PHARMS
NOREPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

LEVOPHED

AP
+ HOSPIRA
NOREPINEPHRINE BITARTRATE

AP
BEDFORD
AP
CLARIS LIFESCIENCES
AP
TEVA PHARMS USA
NORETHINDRONE

TABLET;ORAL-28

CAMILA

AB1
BARR
HEATHER

AB1
GLENMARK GENERICS
NOR-QD

AB1 + ACTAVIS LABS UT INC

NORETHINDRONE

AB1
HAUPT PHARMA
AB1
JAI PHARMA LTD
AB1
LUPIN LTD
AB1
NOVAST LABS LTD
ERRIN

AB2
BARR
JENCYCLA

AB2
LUPIN LTD
MICRONOR

AB2 + JANSSEN PHARMS
NORETHINDRONE

AB2
GLENMARK GENERICS
AB2
JAI PHARMA LTD
AB2
NOVAST LABS

5MG/ML

A072034 001 May 24, 1988

0.4%

N021359 001 Jun 21, 2011

2%

A087355 001 Jul 08, 1988

0.4MG/SPRAY

A091496 001 Sep 20, 2013

0.4MG/SPRAY

N018705 002 Jan 10, 1997

0.3MG
0.4MG
0.6MG

N021134 001 May 01, 2000

N021134 002 May 01, 2000

N021134 003 May 01, 2000

150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG

A075668
A075668
A077314
A077314
A090618
A090618
A075806
A075806
A076178
A076178
A075616
A075616

15MG/ML

N021494 001 May 25, 2004

15MG/ML

A090576 001 Nov 18, 2009

EQ 1MG BASE/ML

N007513 001

EQ 1MG BASE/ML
EQ 1MG BASE/ML
EQ 1MG BASE/ML

A040462 001 Oct 31, 2003

A040859 001 Mar 27, 2012

A040455 001 Mar 03, 2003

0.35MG

A076177 001 Oct 21, 2002

0.35MG

A090454 001 Apr 23, 2010

0.35MG

N017060 001

0.35MG
0.35MG
0.35MG
0.35MG

A202260
A201483
A091325
A202014

0.35MG

A076225 001 Oct 21, 2002

0.35MG

A091323 001 Mar 28, 2013

0.35MG

N016954 001

0.35MG
0.35MG
0.35MG

A091209 001 Jul 21, 2010

A200980 001 Jun 12, 2013

A200961 001 Sep 13, 2013

001
002
001
002
001
002
001
002
001
002
001
002

001
001
001
001

Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

Aug
Jun
Sep
Sep

12,
12,
15,
15,
15,
15,
05,
05,
05,
05,
09,
09,

01,
24,
19,
13,

2002

2002

2005

2005

2011

2011

2002

2002

2002

2002

2002

2002

2013

2013

2011

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-280(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NORETHINDRONE ACETATE

TABLET;ORAL

AYGESTIN

AB
+ DURAMED RES
NORETHINDRONE ACETATE

AB
AMNEAL PHARMS
AB
AUROBINDO PHARMA LTD
AB
BARR
AB
GLENMARK GENERICS

5MG

N018405 001 Apr 21, 1982

5MG
5MG
5MG
5MG

A200275
A204236
A075951
A091090

001
001
001
001

Jul
Jan
May
Jul

30,
08,
25,
21,

2012

2016

2001

2010

Jul
Jul
Jul
Jul
May
May
May
May
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

26,
26,
26,
26,
08,
08,
08,
08,
27,
27,
27,
27,
30,
30,
30,
30,

1993

1993

1993

1993

2000

2000

2000

2000

1995

1995

1995

1995

1992

1992

1992

1992

NORTRIPTYLINE HYDROCHLORIDE

CAPSULE;ORAL

NORTRIPTYLINE HYDROCHLORIDE

AB
MYLAN
EQ
AB
EQ
AB
EQ
AB
EQ
AB
TARO
EQ
AB
EQ
AB
EQ
AB
EQ
AB
TEVA
EQ
AB
EQ
AB
EQ
AB
EQ
AB
WATSON LABS
EQ
AB
EQ
AB
EQ
AB
EQ
PAMELOR

AB
MALLINCKRODT LLC
EQ
AB
EQ
AB
EQ
AB
+
EQ
SOLUTION;ORAL

NORTRIPTYLINE HYDROCHLORIDE

AA
+ PHARM ASSOC
EQ
AA
TARO
EQ
NYSTATIN

CREAM;TOPICAL

NYSTATIN

AT
ACTAVIS MID ATLANTIC
AT
FOUGERA PHARMS
AT
G AND W LABS INC
AT
PERRIGO NEW YORK
AT
+ TARO
AT
VINTAGE
OINTMENT;TOPICAL

NYSTATIN

AT
ACTAVIS MID ATLANTIC
AT
+ FOUGERA PHARMS
AT
PERRIGO NEW YORK
POWDER;TOPICAL

NYSTATIN

AT
+ COASTAL PHARMS
AT
GAVIS PHARMS
AT
UPSHER SMITH
AT
X GEN PHARMS
NYSTOP

AT
PADDOCK LLC
SUSPENSION;ORAL

NYSTATIN

AA
FOUGERA
AA
G AND W LABS INC
AA
HI TECH PHARMA
AA
PHARM ASSOC
AA
TARO
AA
VINTAGE PHARMS
AA
VISTAPHARM
AA
AA
+ WOCKHARDT

10MG
25MG
50MG
75MG
10MG
25MG
50MG
75MG
10MG
25MG
50MG
75MG
10MG
25MG
50MG
75MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A074234
A074234
A074234
A074234
A075520
A075520
A075520
A075520
A074132
A074132
A074132
A074132
A073553
A073554
A073555
A073556

001
002
003
004
004
003
001
002
001
002
003
004
001
001
001
001

10MG
25MG
50MG
75MG

BASE
BASE
BASE
BASE

N018013
N018013
N018013
N018013

001

002

004

003

10MG BASE/5ML
10MG BASE/5ML

100,000
100,000
100,000
100,000
100,000
100,000

UNITS/GM
UNITS/GM
UNITS/GM
UNITS/GM
UNITS/GM
UNITS/GM

A075606 001 Aug 28, 2000

A077965 001 Jun 20, 2006

A062949
A062129
A061966
A062225
A064022
A065315

001 Jun 13, 1988

001

001

001

001 Jan 29, 1993

001 May 31, 2006

100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM

A062840 001 Nov 13, 1987

A062124 002 Sep 23, 1982

A062472 001 Feb 13, 1984

100,000
100,000
100,000
100,000

A065203
A065138
A065183
A065175

UNITS/GM
UNITS/GM
UNITS/GM
UNITS/GM

001
001
001
001

Jul
Jul
May
Dec

15,
23,
03,
17,

2004

2004

2005

2004

100,000 UNITS/GM

A064118 001 Aug 16, 1996

100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000

A062517
A062349
A064042
A203621
A062876
A065148
A064142
A065422
A062512

UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML

001
001
001
001
001
001
001
001
001

Jun
Jul
Feb
Jan
Feb
Jun
Jun
Mar
Oct

07,
14,
28,
07,
29,
28,
25,
07,
29,

1984

1982

1994

2016

1988

2005

1998

2011

1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-281(of 388)

PRESCRIPTION DRUG PRODUCT LIST

NYSTATIN

TABLET;ORAL

NYSTATIN

AA
HERITAGE PHARMS INC
AA
MUTUAL PHARM
AA
+ TEVA
TABLET;VAGINAL

NYSTATIN

+ ODYSSEY PHARMS

500,000 UNITS
500,000 UNITS
500,000 UNITS

A062474 001 Dec 22, 1983

A062838 001 Dec 22, 1988

A062506 001 Jan 16, 1984

100,000 UNITS

A062615 001 Oct 17, 1985

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

MYKACET

AT
G AND W LABS INC
100,000 UNITS/GM;0.1%
NYSTATIN AND TRIAMCINOLONE ACETONIDE

AT
FOUGERA
100,000 UNITS/GM;0.1%
AT
+ TARO
100,000 UNITS/GM;0.1%
OINTMENT;TOPICAL

MYKACET

AT
G AND W LABS INC
100,000 UNITS/GM;0.1%
NYSTATIN AND TRIAMCINOLONE ACETONIDE

AT
FOUGERA
100,000 UNITS/GM;0.1%
AT
+ TARO
100,000 UNITS/GM;0.1%
OCTREOTIDE ACETATE

INJECTABLE;INJECTION

OCTREOTIDE ACETATE

AP
+ EUROHLTH INTL SARL
EQ 0.2MG BASE/ML
AP
+
EQ 1MG BASE/ML
AP
FRESENIUS KABI USA
EQ 0.2MG BASE/ML
AP
EQ 1MG BASE/ML
AP
SAGENT PHARMS
EQ 0.2MG BASE/ML
AP
EQ 1MG BASE/ML
AP
SUN PHARM INDS
EQ 0.05MG BASE/ML
AP
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.2MG BASE/ML
AP
EQ 0.2MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
EQ 1MG BASE/ML
AP
EQ 1MG BASE/ML
AP
TEVA PHARMS USA
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.2MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
EQ 1MG BASE/ML
AP
WOCKHARDT USA
EQ 0.2MG BASE/ML
AP
EQ 1MG BASE/ML
OCTREOTIDE ACETATE (PRESERVATIVE FREE)

AP
+ EUROHLTH INTL SARL
EQ 0.05MG BASE/ML
AP
+
EQ 0.1MG BASE/ML
AP
+
EQ 0.5MG BASE/ML
AP
FRESENIUS KABI USA
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
MYLAN INSTITUTIONAL
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
SAGENT PHARMS
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
WOCKHARDT USA
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.5MG BASE/ML
SANDOSTATIN

AP
+ NOVARTIS
EQ 0.05MG BASE/ML
AP
+
EQ 0.1MG BASE/ML
AP
+
EQ 0.2MG BASE/ML
AP
+
EQ 0.5MG BASE/ML
AP
+
EQ 1MG BASE/ML

A062367 001 May 28, 1985

A062599 001 Oct 08, 1985

A062364 001 Dec 22, 1987

A062733 001 Mar 09, 1987

A062602 001 Oct 09, 1985

A063305 001 Mar 29, 1993

A076330
A076330
A077450
A077450
A091041
A091041
A077329
A077372
A077329
A077372
A077330
A077373
A077329
A077372
A077331
A077373
A075957
A075957
A075959
A075957
A075959
A090986
A090986

001
002
001
002
001
002
001
001
002
002
001
001
003
003
001
002
001
002
001
003
002
001
002

Apr
Apr
Feb
Feb
Nov
Nov
Mar
Aug
Mar
Aug
Mar
Aug
Mar
Aug
Mar
Aug
Oct
Oct
Nov
Oct
Nov
May
May

08,
08,
10,
10,
12,
12,
04,
14,
04,
14,
04,
14,
04,
14,
04,
14,
03,
03,
21,
03,
21,
11,
11,

2005

2005

2006

2006

2013

2013

2008

2007

2008

2007

2008

2007

2008

2007

2008

2007

2005

2005

2005

2005

2005

2011

2011

A076313
A076313
A076313
A077457
A077457
A077457
A079198
A079198
A079198
A090834
A090834
A090834
A090985
A090985
A090985

001
003
002
001
002
003
001
002
003
001
002
003
001
002
003

Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Nov
Nov
Nov
May
May
May

28,
28,
28,
10,
10,
10,
10,
10,
10,
12,
12,
12,
11,
11,
11,

2005

2005

2005

2006

2006

2006

2011

2011

2011

2013

2013

2013

2011

2011

2011

N019667
N019667
N019667
N019667
N019667

001
002
004
003
005

Oct
Oct
Jun
Oct
Jun

21,
21,
12,
21,
12,

1988

1988

1991

1988

1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-282(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OCTREOTIDE ACETATE

INJECTABLE;INJECTION

SANDOSTATIN LAR

NOVARTIS
+
OFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

OCUFLOX

AT
+ ALLERGAN
OFLOXACIN

AT
AKORN
AT
ALCON PHARMS LTD
AT
ALTAIRE PHARMS INC
AT
BAUSCH AND LOMB
AT
FDC LTD
AT
FERA PHARMS
AT
HI TECH PHARMA
SOLUTION/DROPS;OTIC

FLOXIN OTIC

AT
+ DAIICHI
OFLOXACIN

AT
ALCON PHARMS LTD
AT
APOTEX INC
AT
BAUSCH AND LOMB
AT
FERA PHARMS
AT
HI TECH PHARMA
TABLET;ORAL

OFLOXACIN

AB
CADILA PHARMS LTD
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
LARKEN LABS
AB
TEVA
AB
AB
+
OLANZAPINE

INJECTABLE;INTRAMUSCULAR

OLANZAPINE

AP
LUITPOLD
AP
SANDOZ INC
ZYPREXA

AP
+ LILLY
TABLET;ORAL

OLANZAPINE

AB
ALKEM LABS LTD
AB
AB
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB

EQ 10MG BASE/VIAL
EQ 20MG BASE/VIAL
EQ 30MG BASE/VIAL

N021008 001 Nov 25, 1998

N021008 002 Nov 25, 1998

N021008 003 Nov 25, 1998

0.3%

N019921 001 Jul 30, 1993

0.3%
0.3%
0.3%
0.3%
0.3%
0.3%
0.3%

A076407
A076231
A202692
A076622
A078559
A076830
A076615

0.3%

N020799 001 Dec 16, 1997

0.3%
0.3%
0.3%
0.3%
0.3%

A078222
A076527
A076128
A090395
A076616

001
001
001
001
001

Mar
Sep
Mar
Aug
Mar

17,
28,
17,
11,
17,

2008

2007

2008

2009

2008

200MG
300MG
400MG
200MG
300MG
400MG
400MG
200MG
300MG
400MG

A091656
A091656
A091656
A077098
A077098
A077098
A076093
A076182
A076182
A076182

001
002
003
001
002
003
003
001
002
003

Sep
Sep
Sep
Feb
Feb
Feb
Sep
Sep
Sep
Sep

18,
18,
18,
10,
10,
10,
02,
02,
02,
02,

2014

2014

2014

2006

2006

2006

2003

2003

2003

2003

10MG/VIAL
10MG/VIAL

A201741 001 Mar 20, 2012

A201588 001 Oct 24, 2011

10MG/VIAL

N021253 001 Mar 29, 2004

2.5MG
5MG
7.5MG
10MG
15MG
20MG
2.5MG
5MG
7.5MG
10MG
15MG
20MG
2.5MG
5MG
7.5MG
10MG
15MG
20MG
2.5MG
5MG
7.5MG
10MG
15MG

A202295
A202295
A202295
A202295
A202295
A202295
A090798
A090798
A090798
A090798
A090798
A090798
A202050
A202050
A202050
A202050
A202050
A202050
A076255
A076255
A076255
A076255
A076133

001
001
001
001
001
001
001

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
001

Apr
May
Apr
May
Feb
Aug
May

Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

15,
14,
29,
14,
25,
31,
14,

20,
20,
20,
20,
20,
20,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,

2008

2004

2013

2004

2009

2004

2004

2015

2015

2015

2015

2015

2015

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-283(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OLANZAPINE

TABLET;ORAL

OLANZAPINE

AB
20MG
AB
IVAX PHARMS INC
20MG
AB
MACLEODS PHARMS LTD
2.5MG
AB
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
MYLAN
2.5MG
AB
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
ORCHID HLTHCARE
2.5MG
AB
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
SUN PHARM INDS
2.5MG
AB
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
TEVA PHARMS
2.5MG
AB
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
TORRENT PHARMS LTD
2.5MG
AB
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
ZYPREXA

AB
LILLY
2.5MG
AB
+
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
TABLET, ORALLY DISINTEGRATING;ORAL

OLANZAPINE

AB
APOTEX INC
5MG
AB
10MG
AB
15MG
AB
20MG
AB
AUROBINDO PHARMA LTD
5MG
AB
10MG
AB
15MG
AB
20MG
AB
BARR LABS INC
5MG
AB
10MG
AB
15MG
AB
20MG
AB
DR REDDYS LABS LTD
5MG
AB
10MG
AB
15MG
AB
20MG
AB
JUBILANT GENERICS
5MG
AB
10MG
AB
15MG
AB
20MG
AB
MACLEODS PHARMS LTD
5MG
AB
10MG
AB
15MG

A076133
A077301
A202862
A202862
A202862
A202862
A202862
A202862
A076866
A076866
A076866
A076866
A076866
A076866
A202287
A202287
A202287
A202287
A202287
A202287
A091038
A091038
A091038
A091038
A091038
A091038
A076000
A076000
A076000
A076000
A076000
A091434
A091434
A091434
A091434
A091434
A091434

002
001
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
001
002
003
004
005
006

Oct
Apr
Aug
Aug
Aug
Aug
Aug
Aug
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Apr

24,
29,
15,
15,
15,
15,
15,
15,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
24,
24,
24,
24,
24,
23,
23,
23,
23,
23,
23,

2011

2015

2014

2014

2014

2014

2014

2014

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2011

2011

2011

2011

2011

2012

2012

2012

2012

2012

2012

N020592
N020592
N020592
N020592
N020592
N020592

001
002
003
004
005
006

Sep
Sep
Sep
Sep
Sep
Sep

30,
30,
30,
30,
09,
09,

1996

1996

1996

1996

1997

1997

A091265
A091265
A091265
A091265
A203708
A203708
A203708
A203708
A077243
A077243
A077243
A077243
A076534
A076534
A076534
A076534
A200221
A200221
A200221
A200221
A203044
A203044
A203044

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003

Oct
Oct
Oct
Oct
May
May
May
May
Jan
Jan
Jan
Jan
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Feb
Feb
Feb

24,
24,
24,
24,
15,
15,
15,
15,
30,
30,
30,
30,
24,
24,
24,
24,
12,
12,
12,
12,
20,
20,
20,

2011

2011

2011

2011

2014

2014

2014

2014

2012

2012

2012

2012

2011

2011

2011

2011

2012

2012

2012

2012

2015

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-284(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OLANZAPINE

TABLET, ORALLY DISINTEGRATING;ORAL

OLANZAPINE

AB
20MG

AB
MYLAN PHARMS INC
5MG

AB
10MG

AB
15MG

AB
20MG

AB
ORCHID HLTHCARE
5MG

AB
10MG

AB
15MG

AB
20MG

AB
PAR PHARM
5MG

AB
10MG

AB
15MG

AB
20MG

AB
SUN PHARM INDS
5MG

AB
10MG

AB
15MG

AB
20MG

AB
TORRENT PHARMS LLC
5MG

AB
10MG

AB
15MG

AB
20MG

ZYPREXA ZYDIS

AB
+ LILLY
5MG
AB
10MG
AB
15MG
AB
20MG

A203044
A202285
A202285
A202285
A202285
A202937
A202937
A202937
A202937
A078109
A078109
A078109
A078109
A090881
A090881
A090881
A090881
A091415
A091415
A091415
A091415

004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Feb
May
May
May
May
Mar
Mar
Mar
Mar
Oct
Oct
Oct
Oct
Feb
Feb
Feb
Feb
Oct
Oct
Oct
Oct

20,
12,
12,
12,
12,
02,
02,
02,
02,
24,
24,
24,
24,
28,
28,
28,
28,
25,
25,
25,
25,

2015

2014

2014

2014

2014

2015

2015

2015

2015

2011

2011

2011

2011

2012

2012

2012

2012

2011

2011

2011

2011

N021086
N021086
N021086
N021086

001
002
003
004

Apr
Apr
Apr
Apr

06,
06,
06,
06,

2000

2000

2000

2000

OLANZAPINE PAMOATE

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ZYPREXA RELPREVV

ELI LILLY CO

EQ 210MG BASE/VIAL

EQ 300MG BASE/VIAL

+

EQ 405MG BASE/VIAL

N022173 001 Dec 11, 2009

N022173 002 Dec 11, 2009

N022173 003 Dec 11, 2009

OLAPARIB

CAPSULE;ORAL

LYNPARZA

ASTRAZENECA PHARMS

50MG

N206162 001 Dec 19, 2014

OLIVE OIL; SOYBEAN OIL

INJECTABLE;INJECTION

CLINOLIPID 20%

+ BAXTER HLTHCARE

16%(160GM/1000ML);4%

OLMESARTAN MEDOXOMIL

TABLET;ORAL

BENICAR

DAIICHI SANKYO

+

OLODATEROL HYDROCHLORIDE

SPRAY, METERED;INHALATION

STRIVERDI RESPIMAT

+ BOEHRINGER INGELHEIM

(40GM/1000ML)

5MG

20MG

40MG

N021286 001 Apr 25, 2002

N021286 003 Apr 25, 2002

N021286 004 Apr 25, 2002

EQ 0.0025MG BASE/INH

N203108 001 Jul 31, 2014

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

SPRAY, METERED;INHALATION

STIOLTO RESPIMAT

+ BOEHRINGER INGELHEIM
EQ 0.0025MG BASE/INH;EQ 0.0025MG

BASE/INH

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

OLOPATADINE HYDROCHLORIDE

AT
APOTEX INC
AT
AUROBINDO PHARMA LTD
AT
BARR LABS INC
AT
NOVEL LABS INC
AT
USV NORTH AMERICA
AT
ZACH SYSTEM SPA
PATADAY
AT
+ ALCON PHARMS LTD

N204508 001 Oct 03, 2013

EQ
EQ
EQ
EQ
EQ
EQ

0.1%
0.1%
0.2%
0.1%
0.1%
0.1%

BASE

BASE

BASE

BASE

BASE

BASE

EQ 0.2% BASE

N206756 001 May 21, 2015

A078350
A204812
A090848
A206306
A203152
A204706

001
001
001
001
001
001

Dec
Dec
Jul
Dec
Dec
Dec

07,
18,
13,
07,
07,
07,

2015

2015

2015

2015

2015

2015

N021545 001 Dec 22, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-285(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

PATANOL

AT
+ ALCON

PAZEO

+ ALCON RES LTD

SPRAY, METERED;NASAL

OLOPATADINE HYDROCHLORIDE

AB
APOTEX INC

PATANASE

AB
+ ALCON PHARMS LTD

EQ 0.1% BASE

N020688 001 Dec 18, 1996

EQ 0.7% BASE

N206276 001 Jan 30, 2015

0.665MG/SPRAY

A091572 001 Oct 08, 2014

0.665MG/SPRAY

N021861 001 Apr 15, 2008

OLSALAZINE SODIUM

CAPSULE;ORAL

DIPENTUM

+ MEDA PHARMS

250MG

N019715 001 Jul 31, 1990

OMACETAXINE MEPESUCCINATE

POWDER;SUBCUTANEOUS

SYNRIBO

+ IVAX INTL

3.5MG/VIAL

N203585 001 Oct 26, 2012

OMBITASVIR; PARITAPREVIR; RITONAVIR

TABLET;ORAL

TECHNIVIE

+ ABBVIE INC

12.5MG;75MG;50MG

N207931 001 Jul 24, 2015

OMEGA-3-ACID ETHYL ESTERS

CAPSULE;ORAL

LOVAZA
AB
+ SMITHKLINE BEECHAM

1GM CONTAINS AT LEAST 900MG OF THE

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

N021654 001 Nov 10, 2004

1 GM CONTAINS AT LEAST 900MG OF THE

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

1GM CONTAINS AT LEAST 900MG OF THE

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

1GM CONTAINS AT LEAST 900MG OF THE

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

1GM CONTAINS AT LEAST 900MG OF THE

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

A204940 001 Nov 27, 2015

1.2GM CONTAINS AT LEAST 900MG OF THE

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

N204977 001 Apr 23, 2014

1GM CONTAINS AT LEAST 850MG OF

POLYUNSATURATED FATTY ACIDS

N205060 001 May 05, 2014

AB

OMEGA-3-ACID ETHYL ESTERS

AMNEAL PHARMS

AB

APOTEX INC

AB

PAR PHARM INC

AB

TEVA PHARMS USA

OMTRYG
+ TRYGG

OMEGA-3-CARBOXYLIC ACIDS

CAPSULE;ORAL

EPANOVA

+ ASTRAZENECA PHARMS

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

OMEPRAZOLE
AB
ACTAVIS LABS FL INC
10MG
AB
20MG
AB
40MG
AB
APOTEX
10MG
AB
20MG
AB
40MG
AB
AUROBINDO PHARMA USA
10MG
AB
20MG
AB
40MG
AB
DR REDDYS LABS LTD
10MG
AB
10MG
AB
20MG
AB
20MG
AB
40MG
AB
40MG
AB
GLENMARK GENERICS
10MG
AB
20MG
AB
40MG
AB
IMPAX LABS
10MG
AB
20MG
AB
40MG
AB
KREMERS URBAN PHARMS
10MG
AB
20MG

A090973 001 Sep 30, 2014

A091018 001 Jun 24, 2014

A091028 001 Apr 07, 2014

A075347
A075347
A075347
A076048
A076048
A076048
A203270
A203270
A203270
A075576
A078490
A075576
A078490
A075576
A078490
A091672
A091672
A091672
A075785
A075785
A075785
A075410
A075410

001
002
003
001
002
003
001
002
003
003
002
002
003
001
001
001
002
003
001
002
003
001
002

May
May
May
Oct
Oct
Jan
Aug
Aug
Aug
Oct
Mar
Oct
Mar
Jan
Apr
Oct
Oct
Oct
Oct
Oct
Jan
Nov
Nov

30,
30,
30,
22,
22,
21,
19,
19,
19,
22,
16,
22,
16,
21,
17,
31,
31,
31,
22,
22,
21,
01,
01,

2008

2008

2008

2007

2007

2009

2015

2015

2015

2007

2009

2007

2009

2009

2009

2014

2014

2014

2007

2007

2009

2002

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-286(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

OMEPRAZOLE

AB
40MG
AB
LUPIN LTD
40MG
AB
MYLAN
10MG
AB
20MG
AB
40MG
AB
SANDOZ
10MG
AB
20MG
AB
40MG
AB
ZYDUS PHARMS USA INC
10MG
AB
20MG
AB
40MG
PRILOSEC

AB
ASTRAZENECA PHARMS
10MG
AB
+
20MG
AB
+
40MG

N019810 003 Oct 05, 1995

N019810 001 Sep 14, 1989

N019810 002 Jan 15, 1998

OMEPRAZOLE MAGNESIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL

PRILOSEC

ASTRAZENECA PHARMS
EQ 2.5MG BASE/PACKET
+
EQ 10MG BASE/PACKET

N022056 001 Mar 20, 2008

N022056 002 Mar 20, 2008

A075410
A202384
A075876
A075876
A075876
A075757
A075757
A076515
A091352
A091352
A091352

OMEPRAZOLE; SODIUM BICARBONATE

CAPSULE;ORAL

OMEPRAZOLE AND SODIUM BICARBONATE

AB
PAR PHARM
20MG;1.1GM
AB
40MG;1.1GM
ZEGERID

AB
SANTARUS INC
20MG;1.1GM
AB
+
40MG;1.1GM
FOR SUSPENSION;ORAL

ZEGERID

SANTARUS INC
20MG/PACKET;1.68GM/PACKET
+
40MG/PACKET;1.68GM/PACKET
ONDANSETRON

FILM;ORAL

ZUPLENZ

GALENA BIOPHARMA INC
4MG
+
8MG
TABLET, ORALLY DISINTEGRATING;ORAL

ONDANSETRON

AB
AUROBINDO PHARMA
4MG
AB
8MG
AB
BARR
4MG
AB
8MG
AB
GLENMARK GENERICS
4MG
AB
8MG
AB
MYLAN
4MG
AB
8MG
AB
SANDOZ
4MG
AB
8MG
AB
SUN PHARM INDS
4MG
AB
8MG
AB
SUN PHARM INDS LTD
4MG
AB
8MG
AB
TEVA
4MG
AB
8MG
ZOFRAN ODT

AB
NOVARTIS PHARMS CORP
4MG
AB
+
8MG
ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION
ONDANSETRON HYDROCHLORIDE
AP
ACCORD HLTHCARE
AP
AUROBINDO PHARMA LTD
AP
BEDFORD
AP
CLARIS PHARMASERVICE
AP
EMCURE PHARMS
AP
EUROHLTH INTL SARL

EQ
EQ
EQ
EQ
EQ
EQ

2MG
2MG
2MG
2MG
2MG
2MG

003
001
001
002
003
001
002
001
001
002
003

Jan
Aug
May
May
Jan
Jan
Jan
Jan
Nov
Nov
Nov

23,
25,
29,
29,
21,
28,
28,
21,
19,
19,
19,

2009

2015

2003

2003

2009

2003

2003

2009

2012

2012

2012

A078966 001 May 25, 2010

A078966 002 May 25, 2010

N021849 001 Feb 27, 2006

N021849 002 Feb 27, 2006

N021636 001 Jun 15, 2004

N021636 002 Dec 21, 2004

N022524 001 Jul 02, 2010

N022524 002 Jul 02, 2010

A090469
A090469
A076693
A076693
A078152
A078152
A078139
A078139
A078050
A078050
A077557
A077557
A078602
A078602
A076810
A076810

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Feb
Feb
Jun
Jun

12,
12,
25,
25,
27,
27,
25,
25,
13,
13,
02,
02,
24,
24,
25,
25,

2010

2010

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2011

2011

2007

2007

N020781 001 Jan 27, 1999

N020781 002 Jan 27, 1999

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

A206846
A202599
A076967
A078288
A090424
A077365

001
001
001
001
001
001

Jul
Dec
Dec
Feb
Apr
Dec

13,
21,
26,
22,
16,
26,

2015
2012
2006
2013
2010
2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-287(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ONDANSETRON HYDROCHLORIDE

INJECTABLE;INJECTION

ONDANSETRON HYDROCHLORIDE
AP
FRESENIUS KABI USA
EQ 2MG BASE/ML

AP
GLAND PHARMA LTD
EQ 2MG BASE/ML

AP
EQ 2MG BASE/ML

AP
HIKMA FARMACEUTICA
EQ 2MG BASE/ML

AP
HOSPIRA
EQ 2MG BASE/ML

AP
EQ 2MG BASE/ML

AP
LANNETT
EQ 2MG BASE/ML

AP
LUITPOLD
EQ 2MG BASE/ML

AP
MYLAN LABS LTD
EQ 2MG BASE/ML

AP
QILU PHARM CO LTD
EQ 2MG BASE/ML

AP
SANDOZ
EQ 2MG BASE/ML

AP
SUN PHARM INDS (IN)
EQ 2MG BASE/ML

AP
TEVA
EQ 2MG BASE/ML

AP
WOCKHARDT
EQ 2MG BASE/ML

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

AP
AUROBINDO PHARMA LTD
EQ 2MG BASE/ML

AP
BD RX
EQ 2MG BASE/ML

AP
BEDFORD LABS
EQ 2MG BASE/ML

AP
CLARIS PHARMASERVICE
EQ 2MG BASE/ML

AP
EMCURE PHARMS LTD
EQ 2MG BASE/ML

AP
EUROHLTH INTL SARL
EQ 2MG BASE/ML

AP
FRESENIUS KABI USA
EQ 2MG BASE/ML

AP
HIKMA FARMACEUTICA
EQ 2MG BASE/ML

AP
HOSPIRA
EQ 2MG BASE/ML

AP
LUITPOLD
EQ 2MG BASE/ML

AP
MYLAN LABS LTD
EQ 2MG BASE/ML

AP
SANDOZ
EQ 2MG BASE/ML

AP
SUN PHARM INDS LTD
EQ 2MG BASE/ML

AP
TEVA
EQ 2MG BASE/ML

AP
WOCKHARDT
EQ 2MG BASE/ML

ZOFRAN
AP
+ NOVARTIS PHARMS CORP
EQ 2MG BASE/ML

ZOFRAN PRESERVATIVE FREE
AP
+ NOVARTIS PHARMS CORP
EQ 2MG BASE/ML

SOLUTION;ORAL

ONDANSETRON HYDROCHLORIDE

AA
AMNEAL PHARMS

EQ 4MG BASE/5ML

AA
APOTEX

EQ 4MG BASE/5ML

AA
AUROBINDO PHARMA

EQ 4MG BASE/5ML

AA
ROXANE

EQ 4MG BASE/5ML

AA
SILARX

EQ 4MG BASE/5ML

AA
TARO

EQ 4MG BASE/5ML

ZOFRAN

AA
+ NOVARTIS PHARMS CORP
EQ 4MG BASE/5ML

TABLET;ORAL

ONDANSETRON HYDROCHLORIDE

AB
APOTEX

EQ 4MG BASE

AB

EQ 8MG BASE

AB
AUROBINDO PHARMA

EQ 4MG BASE

AB

EQ 8MG BASE

AB

EQ 24MG BASE

AB
DR REDDYS LABS LTD

EQ 4MG BASE

AB

EQ 8MG BASE

AB

EQ 24MG BASE

AB
GLENMARK GENERICS

EQ 4MG BASE

AB

EQ 8MG BASE

AB

EQ 24MG BASE

AB
IPCA LABS LTD

EQ 4MG BASE

AB

EQ 8MG BASE

AB
MYLAN

EQ 4MG BASE

AB

EQ 8MG BASE

AB

EQ 24MG BASE

AB
NATCO PHARMA LTD

EQ 4MG BASE

AB

EQ 8MG BASE

AB
PLIVA HRVATSKA DOO

EQ 4MG BASE

AB

EQ 8MG BASE

AB

EQ 24MG BASE

AB
SANDOZ

EQ 4MG BASE

AB

EQ 8MG BASE

A076974
A079224
A090648
A076781
A077473
A077840
A090883
A079039
A078257
A203711
A077430
A077172
A076876
A077577

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Dec
Sep
Jun
Dec
Dec
Jan
Aug
Nov
Apr
Sep
Jun
Dec
Nov
Dec

26,
25,
15,
26,
26,
19,
05,
18,
23,
08,
27,
26,
22,
26,

2006

2009

2012

2006

2006

2007

2010

2008

2008

2014

2007

2006

2006

2006

A202600
A202253
A077011
A078287
A078945
A077541
A076972
A076780
A077548
A079032
A078244
A077551
A077173
A076759
A077716

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Dec
Jul
Dec
Feb
Jan
Dec
Dec
Dec
Dec
Nov
Apr
Jun
Dec
Nov
Dec

21,
19,
26,
22,
03,
26,
26,
26,
26,
18,
23,
27,
26,
22,
26,

2012

2013

2006

2013

2013

2006

2006

2006

2006

2008

2008

2007

2006

2006

2006

N020007 001 Jan 04, 1991

N020007 003 Dec 10, 1993

A091483
A078127
A078776
A076960
A091342
A077009

001
001
001
001
001
001

Jan
Jun
Nov
Dec
Jan
Nov

31,
25,
28,
26,
27,
30,

2011

2007

2007

2006

2011

2007

N020605 001 Jan 24, 1997

A077306
A077306
A078539
A078539
A078539
A076183
A076183
A076183
A077535
A077535
A077535
A203761
A203761
A076930
A076930
A076930
A077851
A077851
A077112
A077112
A077112
A077517
A077517

001
002
001
002
003
003
002
001
001
002
003
001
002
001
002
004
001
002
001
002
003
001
002

Jun
Jun
Jul
Jul
Jul
Dec
Dec
Dec
Jun
Jun
Jun
Jan
Jan
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

25,
25,
31,
31,
31,
26,
26,
26,
25,
25,
25,
23,
23,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,

2007

2007

2007

2007

2007

2006

2006

2006

2007

2007

2007

2014

2014

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-288(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ONDANSETRON HYDROCHLORIDE

TABLET;ORAL

ONDANSETRON HYDROCHLORIDE

AB
AB
SUN PHARM INDS (IN)
AB
AB
TEVA
AB
AB
ZOFRAN

AB
NOVARTIS PHARMS CORP
AB
AB
+
ONDANSETRON HYDROCHLORIDE

DR REDDYS LABS LTD

EQ
EQ
EQ
EQ
EQ
EQ

24MG BASE
4MG BASE
8MG BASE
4MG BASE
8MG BASE
24MG BASE

A077517
A077050
A077050
A076252
A076252
A076252

003
001
002
001
002
003

Jun
Jun
Jun
Jun
Jun
Jun

25,
25,
25,
25,
25,
25,

2007

2007

2007

2007

2007

2007

EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE

N020103 001 Dec 31, 1992

N020103 002 Dec 31, 1992

N020103 003 Aug 27, 1999

EQ 16MG BASE

A076183 004 Dec 26, 2006

ORITAVANCIN DIPHOSPHATE

POWDER;IV (INFUSION)

ORBACTIV

+ THE MEDICINES CO

EQ 400MG BASE/VIAL

N206334 001 Aug 06, 2014

ORLISTAT

CAPSULE;ORAL

XENICAL

+ HOFFMANN LA ROCHE

120MG

N020766 001 Apr 23, 1999

ORPHENADRINE CITRATE

INJECTABLE;INJECTION

ORPHENADRINE CITRATE

AP
+ AKORN
30MG/ML
AP
EUROHLTH INTL SARL
30MG/ML
AP
SAGENT PHARMS
30MG/ML
AP
WATSON LABS
30MG/ML
TABLET, EXTENDED RELEASE;ORAL

ORPHENADRINE CITRATE

AB
GAVIS PHARMS
100MG
AB
IMPAX PHARMS
100MG
AB
INVAGEN PHARMS
100MG
AB
+ SANDOZ
100MG
AB
TEDOR PHARMA INC
100MG
OSELTAMIVIR PHOSPHATE

CAPSULE;ORAL

TAMIFLU

ROCHE

A040484
A040463
A090585
A084779

001
001
001
001

May
Mar
Aug
Mar

24,
04,
30,
15,

2006

2003

2011

1982

A040284
A040368
A091158
A040327
A040249

001
001
001
001
001

Jun
Jun
Jul
Feb
Jan

19,
23,
27,
15,
29,

1998

2000

2012

2000

1999

EQ 30MG BASE
EQ 45MG BASE
EQ 75MG BASE

N021087 003 Jul 02, 2007

N021087 002 Jul 02, 2007

N021087 001 Oct 27, 1999

EQ 6MG BASE/ML

N021246 002 Mar 21, 2011

OSIMERTINIB MESYLATE

TABLET;ORAL

TAGRISSO

ASTRAZENECA PHARMS
+

EQ 40MG BASE
EQ 80MG BASE

N208065 001 Nov 13, 2015

N208065 002 Nov 13, 2015

OSPEMIFENE

TABLET;ORAL

OSPHENA

+ SHIONOGI INC

60MG

N203505 001 Feb 26, 2013

OXACILLIN SODIUM

INJECTABLE;INJECTION

OXACILLIN SODIUM

AP
AUROBINDO PHARMA LTD
AP
AP
AP
HOSPIRA INC
AP
AP
MYLAN LABS LTD
AP
AP
SAGENT PHARMS
AP
AP
AP
+ SANDOZ

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A201539
A201539
A201538
A203950
A203950
A091486
A091486
A091246
A091246
A091245
A061490

+
FOR SUSPENSION;ORAL

TAMIFLU

+ ROCHE

1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
1GM BASE/VIAL

001
002
001
001
002
001
002
001
002
001
003

Jan
Jan
Jan
Dec
Dec
Aug
Aug
Mar
Mar
Mar

18,
18,
18,
11,
11,
25,
25,
30,
30,
30,

2013

2013

2013

2015

2015

2014

2014

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-289(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OXACILLIN SODIUM

INJECTABLE;INJECTION

OXACILLIN SODIUM

AP
+
EQ 2GM BASE/VIAL
AP
+
EQ 10GM BASE/VIAL
BACTOCILL IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
EQ 20MG BASE/ML
+
EQ 40MG BASE/ML
POWDER;INTRAVENOUS

OXACILLIN SODIUM

AP
+ SANDOZ
EQ 1GM BASE/VIAL
AP
+
EQ 2GM BASE/VIAL
OXALIPLATIN

INJECTABLE;IV (INFUSION)

ELOXATIN

AP
+ SANOFI AVENTIS US
AP
+
OXALIPLATIN

AP
ACTAVIS TOTOWA
AP
AP
EBEWE PHARMA
AP
AP
FRESENIUS KABI ONCOL
AP
AP
AP
AP
FRESENIUS KABI USA
AP
AP
HOSPIRA INC
AP
AP
HOSPIRA WORLDWIDE
AP
AP
JIANGSU HENGRUI MED
AP
AP
MYLAN LABS LTD
AP
AP
AP
AP
SANDOZ
AP
AP
+ SUN PHARMA GLOBAL
AP
AP
+
AP
AP
+ TEVA PHARMS
AP
+
ELOXATIN

+ SANOFI AVENTIS US
OXANDROLONE

TABLET;ORAL

OXANDRIN

AB
GEMINI LABS LLC
AB
+
OXANDROLONE

AB
PAR PHARM
AB
AB
UPSHER SMITH
AB
OXAPROZIN

TABLET;ORAL

DAYPRO

AB
+ GD SEARLE
OXAPROZIN

AB
APOTEX INC
AB
DR REDDYS LABS LTD
AB
IVAX SUB TEVA PHARMS
AB
SANDOZ
AB
SUN PHARM INDS INC
AB
TEVA

A061490 004

A061490 006 May 09, 1991

N050640 001 Oct 26, 1989

N050640 002 Oct 26, 1989

A062737 001 Dec 23, 1986

A062737 002 Dec 23, 1986

50MG/10ML (5MG/ML)
100MG/20ML (5MG/ML)

N021759 001 Jan 31, 2005

N021759 002 Jan 31, 2005

50MG/VIAL
100MG/VIAL
50MG/10ML (5MG/ML)
100MG/20ML (5MG/ML)
50MG/10ML (5MG/ML)
100MG/20ML (5MG/ML)
50MG/VIAL
100MG/VIAL
50MG/VIAL
100MG/VIAL
50MG/VIAL
100MG/VIAL
50MG/10ML (5MG/ML)
100MG/20ML (5MG/ML)
50MG/10ML (5MG/ML)
100MG/20ML (5MG/ML)
50MG/10ML (5MG/ML)
50MG/VIAL
100MG/20ML (5MG/ML)
100MG/VIAL
50MG/10ML (5MG/ML)
100MG/20ML (5MG/ML)
50MG/VIAL
50MG/10ML (5MG/ML)
100MG/VIAL
100MG/20ML (5MG/ML)
50MG/10ML (5MG/ML)
100MG/20ML (5MG/ML)

A078803
A078803
A078812
A078812
A078811
A078811
A078810
A078810
A078819
A078819
A078815
A078815
A078813
A078813
A203869
A203869
A091358
A200979
A091358
A200979
A078817
A078817
A078818
A202922
A078818
A202922
N022160
N022160

200MG/40ML (5MG/ML)

N021759 003 Nov 17, 2006

2.5MG
10MG

N013718 001

N013718 002 Nov 05, 2001

2.5MG
10MG
2.5MG
10MG

A077827
A077827
A076761
A078033

600MG

N018841 004 Oct 29, 1992

600MG
600MG
600MG
600MG
600MG
600MG

A075987
A075855
A075846
A075845
A075844
A075849

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
002
002
001
002
001
001
002
002
001
002

001
002
001
001

001
001
001
001
001
001

Aug
Aug
Aug
Aug
Jun
Jun
Aug
Aug
Jun
Jun
Sep
Sep
Aug
Aug
Jun
Jun
Aug
Aug
Aug
Aug
Jan
Jan
Aug
Apr
Aug
Apr
Aug
Aug

Jun
Jun
Dec
Mar

Sep
Jan
May
Jan
Jan
Jul

08,
08,
07,
07,
10,
10,
07,
07,
02,
02,
30,
30,
07,
07,
18,
18,
07,
08,
07,
08,
24,
24,
07,
08,
07,
08,
07,
07,

22,
22,
01,
22,

02,
31,
13,
31,
03,
03,

2012

2012

2009

2009

2010

2010

2009

2009

2010

2010

2009

2009

2009

2009

2014

2014

2012

2012

2012

2012

2011

2011

2009

2014

2009

2014

2009

2009

2007

2007

2006

2007

2004

2001

2002

2001

2002

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-290(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OXAZEPAM

CAPSULE;ORAL

OXAZEPAM

AB
ACTAVIS ELIZABETH
AB
AB
+
AB
SANDOZ
AB
AB

10MG
15MG
30MG
10MG
15MG
30MG

OXCARBAZEPINE

SUSPENSION;ORAL

OXCARBAZEPINE

AB
AMNEAL PHARMS
300MG/5ML
AB
ROXANE
300MG/5ML
AB
SUN PHARM INDS LTD
300MG/5ML
TRILEPTAL

AB
+ NOVARTIS
300MG/5ML
TABLET;ORAL

OXCARBAZEPINE

AB
APOTEX INC
150MG
AB
300MG
AB
600MG
AB
BRECKENRIDGE PHARM
150MG
AB
300MG
AB
600MG
AB
CADISTA PHARMS
150MG
AB
300MG
AB
600MG
AB
GLENMARK GENERICS
150MG
AB
300MG
AB
600MG
AB
ROXANE
150MG
AB
300MG
AB
600MG
AB
SUN PHARM INDS
150MG
AB
300MG
AB
600MG
AB
TARO
150MG
AB
300MG
AB
600MG
TRILEPTAL

AB
NOVARTIS
150MG
AB
300MG
AB
+
600MG
TABLET, EXTENDED RELEASE;ORAL

OXTELLAR XR

SUPERNUS PHARMS
150MG
300MG
+
600MG
OXICONAZOLE NITRATE

CREAM;TOPICAL

OXISTAT

+ FOUGERA PHARMS
LOTION;TOPICAL

OXISTAT

+ FOUGERA PHARMS

A072251
A072252
A072253
A071813
A071756
A071814

001
001
001
001
001
001

Apr
Apr
Apr
Apr
Apr
Apr

14,
14,
14,
19,
19,
19,

1988

1988

1988

1988

1988

1988

A202961 001 Sep 17, 2012

A201193 001 Oct 03, 2012

A078734 001 Jun 26, 2009

N021285 001 May 25, 2001

A077747
A077747
A077747
A078069
A078069
A078069
A090239
A090239
A090239
A077802
A077802
A077802
A077795
A077795
A077795
A077794
A077794
A077794
A077801
A077801
A077801

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Apr
Apr
Apr
Jan
Jan
Jan
Jan
Jan
Jan
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Nov
Nov
Nov

09,
09,
09,
11,
11,
11,
25,
25,
25,
09,
09,
09,
09,
09,
09,
09,
09,
09,
15,
15,
15,

2008

2008

2008

2008

2008

2008

2010

2010

2010

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

N021014 001 Jan 14, 2000

N021014 002 Jan 14, 2000

N021014 003 Jan 14, 2000

N202810 001 Oct 19, 2012

N202810 002 Oct 19, 2012

N202810 003 Oct 19, 2012

EQ 1% BASE

N019828 001 Dec 30, 1988

EQ 1% BASE

N020209 001 Sep 30, 1992

OXTRIPHYLLINE

TABLET, EXTENDED RELEASE;ORAL

CHOLEDYL SA

+ WARNER CHILCOTT LLC
400MG
+
600MG
OXYBUTYNIN

FILM, EXTENDED RELEASE;TRANSDERMAL

OXYBUTYNIN

AB
BARR LABS DIV TEVA
3.9MG/24HR
OXYTROL

AB
+ ACTAVIS LABS UT INC
3.9MG/24HR
GEL, METERED;TRANSDERMAL

GELNIQUE 3%

+ ACTAVIS LABS UT INC
3%

A087863 001 May 24, 1983

A086742 001

A090526 001 Mar 04, 2014

N021351 002 Feb 26, 2003

N202513 001 Dec 07, 2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-291(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OXYBUTYNIN CHLORIDE

GEL;TRANSDERMAL

GELNIQUE

+ ACTAVIS LABS UT INC

10%(100MG/PACKET)

SYRUP;ORAL

OXYBUTYNIN CHLORIDE

AA
PHARM ASSOC
5MG/5ML

AA
SILARX
5MG/5ML

AA
VINTAGE PHARMS
5MG/5ML

AA
+ WOCKHARDT
5MG/5ML

TABLET;ORAL

OXYBUTYNIN CHLORIDE

AB
TEVA PHARMS USA

5MG

AB
USL PHARMA

5MG

AB
+ VINTAGE PHARMS

5MG

TABLET, EXTENDED RELEASE;ORAL

DITROPAN XL

AB
JANSSEN PHARMS

5MG

AB

10MG

AB
+

15MG

OXYBUTYNIN CHLORIDE

AB
AMNEAL PHARMS

5MG

AB

10MG

AB

15MG

AB
IMPAX PHARMS

5MG

AB

10MG

AB

15MG

AB
MYLAN

5MG

AB
MYLAN PHARMS INC

10MG

AB

15MG

AB
OSMOTICA PHARM

5MG

AB

10MG

AB

15MG

OXYCODONE HYDROCHLORIDE

CAPSULE;ORAL

OXYCODONE HYDROCHLORIDE

AB
AVANTHI INC

AB
COASTAL PHARMS

AB
LANNETT HOLDINGS INC

AB
+ LEHIGH VALLEY

AB
NOVEL LABS INC

SOLUTION;ORAL

OXYCODONE HYDROCHLORIDE

AA
ANI PHARMS INC

AA
COASTAL PHARMS

AA
LANNETT HOLDINGS INC

AA
LEHIGH VALLEY

AA
+

AA
NOVEL LABS INC

AA
ROXANE

AA

AA
+ VISTAPHARM

AA

AA
WOCKHARDT BIO AG

TABLET;ORAL

OXYCODONE HYDROCHLORIDE

AB
ACTAVIS ELIZABETH

AB

AB

AB
ALVOGEN INC

AB

AB

AB
AMNEAL PHARMS

AB

AB

AB

AB

AB
AUROLIFE PHARMA LLC

AB

AB

AB
AVANTHI INC

AB

N022204 001 Jan 27, 2009

A075137
A074520
A076682
A074868

001
001
001
001

Dec
Mar
Dec
Feb

18,
29,
28,
12,

1998

1996

2004

1997

A071655 001 Nov 14, 1988

A074625 001 Jul 31, 1996

A075079 001 Oct 31, 1997

N020897 001 Dec 16, 1998

N020897 002 Dec 16, 1998

N020897 003 Jun 22, 1999

A204010
A204010
A204010
A076745
A076745
A076745
A076702
A076644
A076644
A078503
A078503
A078503

001
002
003
002
003
001
001
001
002
001
002
003

Nov
Nov
Nov
May
May
Nov
Nov
Nov
May
Feb
Feb
Feb

23,
23,
23,
09,
09,
09,
09,
09,
10,
04,
04,
04,

2015

2015

2015

2007

2007

2006

2006

2006

2007

2009

2009

2009

5MG

5MG

5MG

5MG

5MG

A202773
A203107
A203823
N200534
A204752

001
001
001
001
001

Aug
Jul
Aug
Oct
Aug

17,
26,
01,
20,
24,

2015

2012

2014

2010

2015

5MG/5ML

100MG/5ML

100MG/5ML

5MG/5ML

100MG/5ML

100MG/5ML

5MG/5ML

100MG/5ML

5MG/5ML

100MG/5ML

5MG/5ML

A204979
A204092
A204085
N200535
N200535
A204603
A204037
A203208
N201194
A202537
A206456

001
001
001
002
001
001
001
001
001
001
001

Jun
Jun
Sep
Aug
Oct
Apr
Jul
Jul
Jan
Jul
Jun

01,
05,
09,
22,
20,
29,
15,
12,
12,
30,
16,

2015

2014

2014

2013

2010

2015

2013

2013

2012

2012

2015

5MG

15MG

30MG

5MG

15MG

30MG

5MG

10MG

15MG

20MG

30MG

5MG

15MG

30MG

5MG

10MG

A076636
A076636
A076636
A202116
A202116
A202116
A203638
A203638
A203638
A203638
A203638
A202160
A202160
A202160
A091393
A091393

003
001
002
001
002
003
001
002
003
004
005
001
002
003
001
002

Apr
Feb
Feb
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Nov
Nov
Nov
Aug
Aug

07,
06,
06,
30,
30,
30,
03,
03,
03,
03,
03,
19,
19,
19,
31,
31,

2015

2004

2004

2011

2011

2011

2014

2014

2014

2014

2014

2012

2012

2012

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-292(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OXYCODONE HYDROCHLORIDE

TABLET;ORAL

OXYCODONE HYDROCHLORIDE

AB

AB

AB

AB
COASTAL PHARMS

AB

AB

AB
COREPHARMA

AB

AB

AB
EPIC PHARMA LLC

AB

AB

AB

AB
MALLINCKRODT INC

AB

AB

AB
NESHER PHARMS

AB

AB

AB

AB

AB
RHODES PHARMS

AB

AB

AB

AB

AB
SUN PHARM INDS INC

AB

AB

AB

AB

AB
VINTAGE PHARMS

AB

AB

AB

AB

ROXICODONE

AB
MALLINCKRODT INC

AB
+

AB

OXAYDO

EGALET US INC

15MG

20MG

30MG

5MG

15MG

30MG

5MG

15MG

30MG

5MG

10MG

15MG

30MG

5MG

15MG

30MG

5MG

10MG

15MG

20MG

30MG

5MG

10MG

15MG

20MG

30MG

5MG

10MG

15MG

20MG

30MG

5MG

10MG

15MG

20MG

30MG

A091393
A091393
A091393
A091313
A091313
A091313
A090895
A090895
A090895
A202662
A202662
A202662
A202662
A076758
A076758
A076758
A077290
A077290
A077290
A077290
A077290
A091490
A091490
A091490
A091490
A091490
A090659
A090659
A090659
A090659
A090659
A077712
A077712
A077712
A077712
A077712

5MG

15MG

30MG

N021011 003 May 15, 2009

N021011 001 Aug 31, 2000

N021011 002 Aug 31, 2000

5MG

7.5MG

TABLET, EXTENDED RELEASE;ORAL

OXYCONTIN

PURDUE PHARMA LP

10MG

15MG

20MG

30MG

+

40MG

60MG

80MG

OXYMETHOLONE

TABLET;ORAL

ANADROL-50

+ MEDA PHARMS

OXYMORPHONE HYDROCHLORIDE

INJECTABLE;INJECTION

OPANA

+ ENDO PHARMS

TABLET;ORAL

OPANA

AB
ENDO PHARMS

AB
+

OXYMORPHONE HYDROCHLORIDE

AB
AVANTHI INC

AB

AB
COREPHARMA

003
004
005
001
002
003
001
002
003
001
002
003
004
003
001
002
001
002
003
004
005
001
002
003
004
005
001
005
002
004
003
003
004
001
005
002

Aug
Aug
Aug
Feb
Feb
Feb
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Mar
Jun
Jun
Dec
Dec
Dec
Dec
Dec
Mar
Mar
Mar
Mar
Mar
Apr
Nov
Apr
Nov
Apr
Mar
Apr
Jan
Apr
Jan

31,
31,
31,
18,
18,
18,
24,
24,
24,
22,
22,
22,
22,
19,
30,
30,
08,
08,
08,
08,
08,
09,
09,
09,
09,
09,
10,
06,
10,
06,
10,
02,
13,
31,
13,
31,

2009

2009

2009

2011

2011

2011

2009

2009

2009

2015

2015

2015

2015

2007

2004

2004

2005

2005

2005

2005

2005

2011

2011

2011

2011

2011

2009

2012

2009

2012

2009

2009

2015

2007

2015

2007

N202080 001 Jun 17, 2011

N202080 002 Jun 17, 2011

N022272
N022272
N022272
N022272
N022272
N022272
N022272

001
002
003
004
005
006
007

Apr
Apr
Apr
Apr
Apr
Apr
Apr

05,
05,
05,
05,
05,
05,
05,

2010

2010

2010

2010

2010

2010

2010

50MG

N016848 001

1MG/ML

N011707 002

5MG

10MG

N021611 001 Jun 22, 2006

N021611 002 Jun 22, 2006

5MG

10MG

5MG

A203601 001 Jan 30, 2013

A203601 002 Jan 30, 2013

A201187 001 Dec 15, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-293(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OXYMORPHONE HYDROCHLORIDE

TABLET;ORAL

OXYMORPHONE HYDROCHLORIDE

AB
10MG
AB
MALLINCKRODT INC
5MG
AB
10MG
AB
ROXANE
5MG
AB
10MG
AB
TEVA
5MG
AB
10MG
TABLET, EXTENDED RELEASE;ORAL

OXYMORPHONE HYDROCHLORIDE

AB
ACTAVIS ELIZABETH
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
AB
IMPAX LABS
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
AB
MALLINCKRODT INC
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
AB
PAR PHARM
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
AB
ROXANE
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
AB
SUN PHARM INDS LTD
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
OPANA ER

ENDO PHARMS
5MG
7.5MG
10MG
15MG
20MG
30MG
+
40MG
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

TERRAMYCIN W/ POLYMYXIN B SULFATE

+ PFIZER
EQ 5MG BASE/GM;10,000 UNITS/GM

A061015 001

A201187
A202321
A202321
A090964
A090964
A091443
A091443

002
001
002
001
002
002
001

Dec
Apr
Apr
Sep
Sep
Feb
Feb

15,
25,
25,
27,
27,
15,
15,

2014

2013

2013

2010

2010

2011

2011

A079046
A079046
A079046
A079046
A079046
A079046
A079046
A079087
A079087
A079087
A079087
A079087
A079087
A079087
A202946
A202946
A202946
A202946
A202946
A202946
A202946
A200792
A200792
A200792
A200792
A200792
A200792
A200792
A200822
A200822
A200822
A200822
A200822
A200822
A200822
A203506
A203506
A203506
A203506
A203506
A203506
A203506

003
001
004
002
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
002
003
004
005
006
007
001
001
002
003
004
005
006
007

Jul
Dec
Jul
Dec
Jul
Jul
Jul
Jun
Dec
Jun
Dec
Jun
Jul
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Apr
Apr
Apr
Apr
Apr
Apr
Apr

11,
13,
11,
13,
11,
11,
11,
14,
21,
14,
21,
14,
22,
14,
27,
27,
27,
27,
27,
27,
27,
24,
24,
24,
24,
24,
24,
24,
15,
15,
15,
15,
15,
15,
15,
24,
24,
24,
24,
24,
24,
24,

2013

2010

2013

2010

2013

2013

2013

2010

2010

2010

2010

2010

2010

2010

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2013

2013

2013

2013

2013

2013

2013

2015

2015

2015

2015

2015

2015

2015

N201655
N201655
N201655
N201655
N201655
N201655
N201655

001
002
003
004
005
006
007

Dec
Dec
Dec
Dec
Dec
Dec
Dec

09,
09,
09,
09,
09,
09,
09,

2011

2011

2011

2011

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-294(of 388)

PRESCRIPTION DRUG PRODUCT LIST

OXYTOCIN

INJECTABLE;INJECTION

OXYTOCIN

AP
+ EUROHLTH INTL SARL
AP
+
AP
+ FRESENIUS KABI USA
AP
+
AP
HIKMA FARMACEUTICA
PITOCIN

AP
+ PAR STERILE PRODUCTS
AP
OXYTOCIN

+ FRESENIUS KABI USA
PITOCIN

PAR STERILE PRODUCTS
PACLITAXEL

FOR SUSPENSION;IV (INFUSION)

ABRAXANE

+ ABRAXIS BIOSCIENCE
INJECTABLE;INJECTION

PACLITAXEL

AP
ACTAVIS TOTOWA
AP
EBEWE PHARMA
AP
EUROHLTH INTL SARL
AP
FRESENIUS KABI ONCOL
AP
+ HOSPIRA
AP
MYLAN LABS LTD
AP
TEVA PHARMS
TAXOL

AP
HQ SPCLT PHARMA
PALBOCICLIB

CAPSULE;ORAL

IBRANCE

PFIZER INC
+

10USP UNITS/ML (10USP UNITS/ML)

100USP UNITS/10ML (10USP UNITS/ML)
10USP UNITS/ML (10USP UNITS/ML)
100USP UNITS/10ML (10USP UNITS/ML)
10USP UNITS/ML (10USP UNITS/ML)

N018243
N018243
N018248
N018248
A200219

10USP UNITS/ML (10USP UNITS/ML)

100USP UNITS/10ML (10USP UNITS/ML)

N018261 001

N018261 002 Jul 27, 2007

300USP UNITS/30ML (10USP UNITS/ML)

N018248 003 Jul 27, 2007

500USP UNITS/50ML (10USP UNITS/ML)

N018261 003 Sep 05, 2012

100MG/VIAL

N021660 001 Jan 07, 2005

6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML

A090130
A078167
A075190
A077574
A076131
A091540
A075184

6MG/ML

N020262 001 Dec 29, 1992

75MG
100MG
125MG

N207103 001 Feb 03, 2015

N207103 002 Feb 03, 2015

N207103 003 Feb 03, 2015

PALIPERIDONE

TABLET, EXTENDED RELEASE;ORAL

INVEGA

AB
JANSSEN PHARMS
1.5MG
AB
3MG
AB
+
6MG
AB
9MG
PALIPERIDONE

AB
ACTAVIS LABS FL INC
1.5MG
AB
3MG
AB
6MG
AB
9MG
AB
MYLAN PHARMS INC
1.5MG
AB
3MG
AB
6MG
AB
9MG
PALIPERIDONE PALMITATE

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

INVEGA SUSTENNA

JANSSEN PHARMS
39MG/0.25ML (39MG/0.25ML)
78MG/0.5ML (78MG/0.5ML)
+
117MG/0.75ML (117MG/0.75ML)
156MG/ML (156MG/ML)
234MG/1.5ML (156MG/ML)
INVEGA TRINZA

JANSSEN PHARMS
273MG/0.875ML (273MG/0.875ML)
410MG/1.315ML (311.79MG/ML)
546MG/1.75ML (312MG/ML)
+
819MG/2.625ML (312MG/ML)

001

002 Jan 10, 2007

001

002

001 Feb 13, 2013

001
001
001
001
001
001
001

Dec
Dec
Jan
Nov
May
Sep
Jan

09,
26,
28,
27,
08,
29,
25,

2009

2007

2002

2006

2002

2011

2002

N021999
N021999
N021999
N021999

006
001
002
003

Aug
Dec
Dec
Dec

26,
19,
19,
19,

2008

2006

2006

2006

A202645
A202645
A202645
A202645
A203802
A203802
A203802
A203802

001
002
003
004
001
002
003
004

Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep

03,
03,
03,
03,
24,
24,
24,
24,

2015

2015

2015

2015

2015

2015

2015

2015

N022264
N022264
N022264
N022264
N022264

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

31,
31,
31,
31,
31,

2009

2009

2009

2009

2009

N207946
N207946
N207946
N207946

001
002
003
004

May
May
May
May

18,
18,
18,
18,

2015

2015

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-295(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PALONOSETRON HYDROCHLORIDE

INJECTABLE;INTRAVENOUS

ALOXI

AP
+ HELSINN HLTHCARE
AP
AP
AP
AP

EQ 0.075MG BASE/1.5ML (EQ 0.05MG

BASE/ML)

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

+
PALONOSETRON HYDROCHLORIDE

SANDOZ INC
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
TEVA PHARMS USA
EQ 0.075MG BASE/1.5ML (EQ 0.05MG
BASE/ML)

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

PAMIDRONATE DISODIUM

INJECTABLE;INJECTION

PAMIDRONATE DISODIUM

AP
AREVA PHARMS
AP
AP
AP
EUROHLTH INTL SARL
AP
+
AP
AP
+
AP
FRESENIUS KABI USA
AP
AP
AP
AP
+ HOSPIRA
AP
+
AP
+
AP
LUITPOLD
AP
AP
MUSTAFA NEVZAT
AP
AP
MYLAN LABS LTD
AP
AP
PLIVA LACHEMA
AP
AP
AP
SUN PHARMA GLOBAL
AP
AP
TEVA PHARMS USA
AP

30MG/VIAL
60MG/VIAL
90MG/VIAL
30MG/VIAL
30MG/10ML
90MG/VIAL
90MG/10ML
30MG/VIAL
30MG/10ML
90MG/VIAL
90MG/10ML
30MG/10ML
60MG/10ML
90MG/10ML
30MG/10ML
90MG/10ML
30MG/10ML
90MG/10ML
30MG/10ML
90MG/10ML
30MG/10ML
60MG/10ML
90MG/10ML
30MG/VIAL
90MG/VIAL
30MG/10ML
90MG/10ML

(3MG/ML)
(9MG/ML)
(3MG/ML)
(9MG/ML)
(3MG/ML)
(6MG/ML)
(9MG/ML)
(3MG/ML)
(9MG/ML)
(3MG/ML)
(9MG/ML)
(3MG/ML)
(9MG/ML)
(3MG/ML)
(6MG/ML)
(9MG/ML)

(3MG/ML)
(9MG/ML)

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

CAPSULE, DELAYED RELEASE;ORAL

CREON

ABBVIE
12,000USP UNITS\;38,000USP
UNITS\;60,000USP UNITS\

15,000USP UNITS\;3,000USP
UNITS\;9,500USP UNITS\

19,000USP UNITS\;30,000USP
UNITS\;6,000USP UNITS\

114,000USP UNITS;180,000USP
UNITS;36,000USP UNITS

+
120,000USP UNITS\;24,000USP
UNITS\;76,000USP UNITS\

PANCREAZE

JANSSEN PHARMS
10,850USP UNITS;2,600USP UNITS;6,200USP
UNITS

17,500USP UNITS;4,200USP
UNITS;10,000USP UNITS

43,750USP UNITS;10,500USP
UNITS;25,000USP UNITS

+
61,000USP UNITS;21,000USP
UNITS;37,000USP UNITS

70,000USP UNITS;16,800USP
UNITS;40,000USP UNITS

PERTZYE

DIGESTIVE CARE INC
30,250USP UNITS;8,000USP
UNITS;28,750USP UNITS

+
60,500USP UNITS;16,000USP
UNITS;57,500USP UNITS

ULTRESA

FOREST LABS INC
13,800USP UNITS;27,600USP
UNITS;27,600USP UNITS

20,700USP UNITS;41,400USP UNITS;41,400

N021372 002 Feb 29, 2008

N021372 001 Jul 25, 2003

A202521 001 Oct 13, 2015

A090713 002 Oct 13, 2015

A090713 001 Oct 13, 2015

A077433
A077433
A077433
A075290
N021113
A075290
N021113
A075773
A076207
A075773
A076207
A075841
A075841
A075841
A078942
A078942
A078373
A078373
A078520
A078520
A078156
A078156
A078156
A077703
A077703
A076153
A076153

001
002
003
001
001
003
002
001
001
002
002
001
002
003
001
002
001
002
001
002
001
002
003
001
002
001
002

Nov
Nov
Nov
Apr
Mar
Apr
Mar
May
May
May
May
Jun
Jun
Jun
Jul
Jul
Dec
Dec
Oct
Oct
Aug
Aug
Aug
Dec
Dec
Mar
Mar

26,
26,
26,
30,
04,
30,
04,
06,
17,
06,
17,
27,
27,
27,
25,
25,
23,
23,
31,
31,
19,
19,
19,
24,
24,
27,
27,

2008

2008

2008

2001

2002

2001

2002

2002

2002

2002

2002

2002

2002

2002

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2002

2002

N020725 002 Apr 30, 2009

N020725 004 Jul 12, 2011

N020725 001 Apr 30, 2009

N020725 005 Mar 14, 2013

N020725 003 Apr 30, 2009

N022523 005 Mar 07, 2014

N022523 001 Apr 12, 2010

N022523 002 Apr 12, 2010

N022523 003 Apr 12, 2010

N022523 004 Apr 12, 2010

N022175 001 May 17, 2012

N022175 002 May 17, 2012

N022222 001 Mar 01, 2012

N022222 002 Mar 01, 2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-296(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

CAPSULE, DELAYED RELEASE;ORAL

ULTRESA

USP UNITS

+
23,000USP UNITS;46,000USP
UNITS;46,000USP UNITS

ZENPEP

FOREST LABS INC
218,000USP UNITS; 40,00USP UNITS;
136,000 USP UNITS

10,000USP UNITS;16,000USP
UNITS;3,000USP UNITS

10,000USP UNITS;34,000USP
UNITS;55,000USP UNITS

15,000USP UNITS;51,000USP
UNITS;82,000USP UNITS

17,000USP UNITS;27,000USP
UNITS;5,000USP UNITS

109,000USP UNITS;20,000USP
UNITS;68,000USP UNITS

+
136,000USP UNITS;25,000USP
UNITS;85,000USP UNITS

TABLET;ORAL

VIOKACE

FOREST LABS INC
10440USPU;39150USPU;39150USPU
+
20880USPU;78300USPU;78300USPU
PANCURONIUM BROMIDE

INJECTABLE;INJECTION

PANCURONIUM BROMIDE

AP
HOSPIRA
AP
+ TEVA PHARMS USA
AP
+
PANOBINOSTAT LACTATE

CAPSULE;ORAL

FARYDAK

NOVARTIS PHARMS CORP
+

N022222 003 Mar 01, 2012

N022210 007 Mar 25, 2014

N022210 005 Jun 15, 2011

N022210 002 Aug 27, 2009

N022210 003 Aug 27, 2009

N022210 001 Aug 27, 2009

N022210 004 Aug 27, 2009

N022210 006 Jul 13, 2011

N022542 001 Mar 01, 2012

N022542 002 Mar 01, 2012

1MG/ML
1MG/ML
2MG/ML

A072320 001 Jan 19, 1989

A072759 001 Jul 31, 1990

A072760 001 Jul 31, 1990

EQ 10MG BASE
EQ 15MG BASE
EQ 20MG BASE

N205353 001 Feb 23, 2015

N205353 002 Feb 23, 2015

N205353 003 Feb 23, 2015

PANTOPRAZOLE SODIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL

PROTONIX

+ WYETH PHARMS INC
EQ 40MG
INJECTABLE;IV (INFUSION)

PANTOPRAZOLE SODIUM

AP
AKORN INC
EQ 40MG
AP
SANDOZ INC
EQ 40MG
PROTONIX IV

AP
+ WYETH PHARMS INC
EQ 40MG
TABLET, DELAYED RELEASE;ORAL

PANTOPRAZOLE SODIUM

AB
ACTAVIS TOTOWA
EQ 20MG
AB
EQ 40MG
AB
APOTEX INC
EQ 20MG
AB
EQ 40MG
AB
AUROBINDO PHARMA LTD
EQ 20MG
AB
EQ 40MG
AB
DR REDDYS LABS LTD
EQ 20MG
AB
EQ 40MG
AB
HETERO LABS LTD V
EQ 20MG
AB
EQ 40MG
AB
JUBILANT GENERICS
EQ 20MG
AB
EQ 40MG
AB
KREMERS URBAN PHARMS
EQ 20MG
AB
EQ 40MG
AB
MACLEODS PHARMS LTD
EQ 20MG
AB
EQ 40MG
AB
MYLAN PHARMS INC
EQ 20MG
AB
EQ 40MG
AB
ORCHID HLTHCARE
EQ 20MG
AB
EQ 40MG
AB
PERRIGO R AND D
EQ 20MG
AB
SUN PHARM INDS LTD
EQ 20MG
AB
EQ 40MG

BASE

N022020 001 Nov 14, 2007

BASE/VIAL
BASE/VIAL

A079197 001 Nov 08, 2012

A090296 001 Jul 14, 2015

BASE/VIAL

N020988 001 Mar 22, 2001

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A090797
A090797
A090807
A090807
A202038
A202038
A077619
A077619
A202882
A202882
A090901
A090901
A078281
A078281
A200821
A200821
A090970
A090970
A202052
A202052
A203024
A200794
A200794

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
002

Feb
Feb
May
May
Sep
Sep
Jan
Jan
Sep
Sep
Aug
Aug
Jan
Jan
Feb
Feb
Jan
Jan
Dec
Dec
May
May
May

07,
07,
02,
02,
28,
28,
19,
19,
10,
10,
30,
30,
20,
20,
16,
16,
19,
19,
02,
02,
07,
02,
02,

2011

2011

2012

2012

2012

2012

2011

2011

2014

2014

2011

2011

2011

2011

2012

2012

2011

2011

2014

2014

2014

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-297(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PANTOPRAZOLE SODIUM

TABLET, DELAYED RELEASE;ORAL

PANTOPRAZOLE SODIUM

AB
SUN PHARMA GLOBAL
AB
AB
TEVA
AB
AB
TORRENT PHARMS
AB
AB
WOCKHARDT
AB
PROTONIX

AB
WYETH PHARMS INC
AB
+

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

20MG
40MG
20MG
40MG
20MG
40MG
20MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A077058
A077058
A077056
A077056
A090074
A090074
A091231
A091231

001
002
001
002
001
002
001
002

Sep
Sep
Aug
Aug
Jan
Jan
Jan
Jan

10,
10,
02,
02,
19,
19,
19,
19,

2007

2007

2007

2007

2011

2011

2011

2011

EQ 20MG BASE
EQ 40MG BASE

N020987 002 Jun 12, 2001

N020987 001 Feb 02, 2000

1MCG
2MCG
4MCG
1MCG
2MCG
4MCG
1MCG
2MCG
4MCG
1MCG
2MCG
4MCG
1MCG
2MCG
4MCG
1MCG
2MCG
4MCG

A204327
A204327
A204327
A207672
A207672
A207672
A202539
A202539
A202539
A091412
A091412
A091412
A202124
A202124
A202124
A090829
A090829
A090829

1MCG
2MCG
4MCG

N021606 001 May 26, 2005

N021606 002 May 26, 2005

N021606 003 May 26, 2005

PARICALCITOL

CAPSULE;ORAL

PARICALCITOL

AB
AMNEAL PHARMS
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
BANNER LIFE SCIENCES
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
RISING PHARMS INC
AB
AB
AB
TEVA PHARMS USA
AB
AB
ZEMPLAR

AB
ABBVIE
AB
AB
+
SOLUTION;INTRAVENOUS

PARICALCITOL

AP
HIKMA PHARMS
AP
AP
AP
HOSPIRA INC
AP
AP
AP
SANDOZ CANADA INC
AP
AP
ZEMPLAR

AP
+ ABBVIE
AP
+
AP
+

0.002MG/ML (0.002MG/ML)
0.005MG/ML (0.005MG/ML)
0.01MG/2ML (0.005MG/ML)

N020819 002 Feb 01, 2000

N020819 001 Apr 17, 1998

N020819 003 Feb 01, 2000

PAROMOMYCIN SULFATE

CAPSULE;ORAL

PAROMOMYCIN SULFATE

AA
HERITAGE PHARMS INC
AA
+ SUN PHARM INDS INC

EQ 250MG BASE
EQ 250MG BASE

A065173 001 Dec 14, 2007

A064171 001 Jun 30, 1997

EQ 10MG BASE/5ML

N020710 001 Jun 25, 1997

EQ
EQ
EQ
EQ

A203854
A203854
A203854
A203854

PAROXETINE HYDROCHLORIDE

SUSPENSION;ORAL

PAXIL

AB
+ APOTEX TECHNOLOGIES
TABLET;ORAL

PAROXETINE

AB
PRINSTON INC
AB
AB
AB

0.002MG/ML
0.005MG/ML
0.01MG/2ML
0.002MG/ML
0.005MG/ML
0.01MG/2ML
0.002MG/ML
0.005MG/ML
0.01MG/2ML

10MG
20MG
30MG
40MG

(0.002MG/ML)
(0.005MG/ML)
(0.005MG/ML)
(0.002MG/ML)
(0.005MG/ML)
(0.005MG/ML)
(0.002MG/ML)
(0.005MG/ML)
(0.005MG/ML)

BASE
BASE
BASE
BASE

N205917
N205917
N205917
N201657
N201657
N201657
A091108
A091108
A091108

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

001
002
003
001
002
003
001
002
003

001
002
003
004

Jan
Jan
Jan
Jan
Jan
Jan
Mar
Mar
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Sep
Sep
Sep

Nov
Nov
Nov
Oct
Oct
Oct
Jul
Jul
Jul

Oct
Oct
Oct
Oct

13,
13,
13,
14,
14,
14,
27,
27,
27,
24,
24,
24,
24,
24,
24,
27,
27,
27,

18,
18,
18,
21,
21,
21,
27,
27,
27,

31,
31,
31,
31,

2016

2016

2016

2016

2016

2016

2014

2014

2014

2014

2014

2014

2014

2014

2014

2013

2013

2013

2014

2014

2014

2014

2014

2014

2011

2011

2011

2014

2014

2014

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-298(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PAROXETINE HYDROCHLORIDE

TABLET;ORAL

PAROXETINE HYDROCHLORIDE

AB
APOTEX
EQ
AB
EQ
AB
EQ
AB
EQ
AB
AUROBINDO PHARMA
EQ
AB
EQ
AB
EQ
AB
EQ
AB
JUBILANT GENERICS
EQ
AB
EQ
AB
EQ
AB
EQ
AB
MYLAN
EQ
AB
EQ
AB
EQ
AB
EQ
AB
MYLAN PHARMS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
PROSAM LABS
EQ
AB
EQ
AB
EQ
AB
EQ
AB
SUN PHARM INDS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
TEVA
EQ
AB
EQ
AB
EQ
AB
EQ
AB
ZYDUS PHARMS USA
EQ
AB
EQ
AB
EQ
AB
EQ
PAXIL

AB
APOTEX TECHNOLOGIES
EQ
AB
EQ
AB
EQ
AB
+
EQ
TABLET, EXTENDED RELEASE;ORAL

PAROXETINE HYDROCHLORIDE

AB
MYLAN
EQ
AB
EQ
AB
EQ
PAXIL CR

AB
APOTEX TECHNOLOGIES
EQ
AB
EQ
AB
+
EQ
PAROXETINE MESYLATE

CAPSULE;ORAL

BRISDELLE

+ NOVEN THERAP
TABLET;ORAL

PEXEVA

NOVEN THERAP

+
PASIREOTIDE DIASPARTATE

SOLUTION;SUBCUTANEOUS

SIGNIFOR

NOVARTIS
+

10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A075356
A075356
A075356
A075356
A078406
A078406
A078406
A078406
A205528
A205528
A205528
A205528
A078902
A078902
A078902
A078902
A075716
A075716
A075716
A075716
A076968
A076968
A076968
A076968
A078194
A078194
A078194
A078194
A076618
A076618
A076618
A076618
A077584
A077584
A077584
A077584

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Nov
Nov
Nov
Nov
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Mar
Mar
Mar
Mar

30,
30,
30,
30,
25,
25,
25,
25,
27,
27,
27,
27,
13,
13,
13,
13,
08,
08,
08,
08,
21,
21,
21,
21,
29,
29,
29,
29,
15,
15,
15,
15,
07,
07,
07,
07,

2003

2003

2003

2003

2007

2007

2007

2007

2015

2015

2015

2015

2008

2008

2008

2008

2004

2004

2004

2004

2010

2010

2010

2010

2007

2007

2007

2007

2005

2005

2005

2005

2007

2007

2007

2007

10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE

N020031
N020031
N020031
N020031

001
002
003
005

Dec
Dec
Dec
Dec

29,
29,
29,
29,

1992

1992

1992

1992

12.5MG BASE
25MG BASE
37.5MG BASE

A077873 001 Jun 29, 2007

A077873 002 Jun 29, 2007

A091427 001 Apr 14, 2011

12.5MG BASE
25MG BASE
37.5MG BASE

N020936 001 Feb 16, 1999

N020936 002 Feb 16, 1999

N020936 003 Dec 06, 2000

EQ 7.5MG BASE

N204516 001 Jun 28, 2013

EQ
EQ
EQ
EQ

N021299
N021299
N021299
N021299

10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE

EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)

EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)
EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)

001
002
003
004

Jul
Jul
Jul
Jul

03,
03,
03,
03,

2003

2003

2003

2003

N200677 001 Dec 14, 2012

N200677 002 Dec 14, 2012

N200677 003 Dec 14, 2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-299(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PASIREOTIDE PAMOATE

POWDER;INTRAMUSCULAR

SIGNIFOR LAR

NOVARTIS PHARMS CORP

EQ 20MG BASE/VIAL

EQ 40MG BASE/VIAL

EQ 60MG BASE/VIAL

N203255 001 Dec 15, 2014

N203255 002 Dec 15, 2014

N203255 003 Dec 15, 2014

EQ 8.4GM BASE/PACKET

EQ 16.8GM BASE/PACKET

EQ 25.2GM BASE/PACKET

N205739 001 Oct 21, 2015

N205739 002 Oct 21, 2015

N205739 003 Oct 21, 2015

PAZOPANIB HYDROCHLORIDE

TABLET;ORAL

VOTRIENT

+ NOVARTIS PHARMS CORP

EQ 200MG BASE

N022465 001 Oct 19, 2009

PEGADEMASE BOVINE

INJECTABLE;INJECTION

ADAGEN

+ SIGMA TAU

250 UNITS/ML

N019818 001 Mar 21, 1990

PEGAPTANIB SODIUM

INJECTABLE;INTRAVITREAL

MACUGEN

+ VALEANT PHARMS LLC

EQ 0.3MG ACID/0.09ML

N021756 001 Dec 17, 2004

PEGVISOMANT

INJECTABLE;SUBCUTANEOUS

SOMAVERT

+ PHARMACIA AND UPJOHN

+

+

+

+

10MG/VIAL

15MG/VIAL

20MG/VIAL

25MG/VIAL

30MG/VIAL

N021106
N021106
N021106
N021106
N021106

PEMETREXED DISODIUM

INJECTABLE;IV (INFUSION)

ALIMTA

+ LILLY

+

EQ 100MG BASE/VIAL

EQ 500MG BASE/VIAL

N021462 002 Sep 07, 2007

N021462 001 Feb 04, 2004

PENCICLOVIR SODIUM

CREAM;TOPICAL

DENAVIR

+ DENCO ASSET

1%

N020629 001 Sep 24, 1996

250MG

N019853 001

250MG

N019854 001

600,000 UNITS/ML

N050141 001

600,000 UNITS/ML

A060014 001

300,000 UNITS/ML

N050141 003

+

PATIROMER SORBITEX CALCIUM

POWDER;ORAL

VELTASSA

RELYPSA INC

+

PENICILLAMINE

CAPSULE;ORAL

CUPRIMINE

+ ATON

TABLET;ORAL

DEPEN

+ MEDA PHARMS

PENICILLIN G BENZATHINE

INJECTABLE;INJECTION

BICILLIN L-A

BC
+ KING PHARMS

PERMAPEN

BC
PFIZER

BICILLIN L-A

+ KING PHARMS

PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE

INJECTABLE;INJECTION

BICILLIN C-R

+ KING PHARMS

150,000 UNITS/ML;150,000 UNITS/ML

+

300,000 UNITS/ML;300,000 UNITS/ML

BICILLIN C-R 900/300

+ KING PHARMS

900,000 UNITS/2ML;300,000 UNITS/2ML

001
002
003
004
005

N050138 002

N050138 001

N050138 003

Mar
Mar
Mar
Jul
Jul

25,
25,
25,
31,
31,

2003

2003

2003

2014

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-300(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PENICILLIN G POTASSIUM

INJECTABLE;INJECTION

PENICILLIN G POTASSIUM

AP
HANFORD GC
5,000,000 UNITS/VIAL
AP
20,000,000 UNITS/VIAL
AP
ISTITUTO BIO ITA SPA
5,000,000 UNITS/VIAL
AP
20,000,000 UNITS/VIAL
AP
SANDOZ
5,000,000 UNITS/VIAL
AP
20,000,000 UNITS/VIAL
PFIZERPEN

AP
+ PFIZER
5,000,000 UNITS/VIAL
AP
+
20,000,000 UNITS/VIAL
PENICILLIN G POTASSIUM

HANFORD GC
1,000,000 UNITS/VIAL
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
20,000 UNITS/ML
+
40,000 UNITS/ML
+
60,000 UNITS/ML
PENICILLIN G PROCAINE

INJECTABLE;INJECTION

PENICILLIN G PROCAINE

+ KING PHARMS
+

300,000 UNITS/ML
600,000 UNITS/ML

PENICILLIN G SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

PENICILLIN G SODIUM

+ SANDOZ
5,000,000 UNITS/VIAL
PENICILLIN V POTASSIUM

FOR SOLUTION;ORAL

PENICILLIN V POTASSIUM

AA
DAVA PHARMS INC
AA
PENICILLIN-VK

AA
TEVA
AA
+
TABLET;ORAL

PENICILLIN V POTASSIUM

AB
AUROBINDO PHARMA
AB
AB
DAVA PHARMS INC
AB
AB
HIKMA PHARMS
AB
AB
SANDOZ
AB
+
PENICILLIN-VK

AB
TEVA
AB

A065149
A065149
A065448
A065448
A065079
A065079

002
003
001
002
002
003

Jul
Jul
Aug
Aug
Aug
Aug

23,
23,
18,
18,
30,
30,

2009

2009

2009

2009

2002

2002

A060657 002

A060657 003

A065149 001 Jul 23, 2009

N050638 001 Jun 25, 1990

N050638 002 Jun 25, 1990

N050638 003 Jun 25, 1990

A060101 002

A060101 001

A065068 001 Feb 26, 2001

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

A062981 001 Feb 10, 1989

A062981 002 Feb 10, 1989

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

A060456 001

A060456 002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A065435
A065435
A062936
A062935
A090549
A090549
A064071
A064071

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
001
001
001
002
001
002

EQ 250MG BASE
EQ 500MG BASE

A060711 002

A060711 003

Apr
Apr
Nov
Nov
Oct
Oct
Nov
Nov

29,
29,
25,
23,
11,
11,
30,
30,

2008

2008

1988

1988

2013

2013

1995

1995

PENTAMIDINE ISETHIONATE

FOR SOLUTION;INHALATION

NEBUPENT

+ FRESENIUS KABI USA
INJECTABLE;INJECTION

PENTAM

+ FRESENIUS KABI USA

300MG/VIAL

N019887 001 Jun 15, 1989

300MG/VIAL

N019264 001 Oct 16, 1984

PENTAZOCINE LACTATE

INJECTABLE;INJECTION

TALWIN

+ HOSPIRA

EQ 30MG BASE/ML

N016194 001

PENTOBARBITAL SODIUM

INJECTABLE;INJECTION

NEMBUTAL SODIUM

+ OAK PHARMS

50MG/ML

A083246 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-301(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PENTOSAN POLYSULFATE SODIUM

CAPSULE;ORAL

ELMIRON

+ JANSSEN PHARMS

PENTOSTATIN

INJECTABLE;INJECTION

NIPENT

AP
+ HOSPIRA INC

PENTOSTATIN

AP
EUROHLTH INTL SARL

AP
MYLAN INSTITUTIONAL

100MG

N020193 001 Sep 26, 1996

10MG/VIAL

N020122 001 Oct 11, 1991

10MG/VIAL

10MG/VIAL

A077841 001 Aug 07, 2007

A203554 001 Sep 19, 2014

PENTOXIFYLLINE

TABLET, EXTENDED RELEASE;ORAL

PENTOXIFYLLINE

AB
APOTEX

400MG

AB
IMPAX LABS

400MG

AB
MYLAN

400MG

AB
PLIVA

400MG

AB
VALEANT PHARMS

400MG

PENTOXIL

AB
UPSHER SMITH

400MG

PERAMIVIR

SOLUTION;IV (INFUSION)

RAPIVAB

+ BIOCRYST

PERAMPANEL

TABLET;ORAL

FYCOMPA

EISAI INC

+

PERFLUTREN

INJECTABLE;INTRAVENOUS

DEFINITY

+ LANTHEUS MEDCL

PERINDOPRIL ERBUMINE

TABLET;ORAL

ACEON

AB
SYMPLMED PHARMS LLC

AB

AB
+

PERINDOPRIL ERBUMINE

AB
ANI PHARMS INC

AB

AB

AB
APOTEX

AB

AB

AB
AUROBINDO PHARMA

AB

AB

AB
LUPIN LTD

AB

AB

AB
ROXANE

AB

AB

PERMETHRIN

CREAM;TOPICAL

ELIMITE

AB
+ RENAISSANCE PHARMA

PERMETHRIN

AB
ACTAVIS MID ATLANTIC

AB
PERRIGO NEW YORK

A075191
A075093
A074425
A074874
A075028

001
001
001
001
001

Jun
Aug
Jul
May
Jul

09,
10,
08,
25,
20,

1999

1999

1997

1999

1998

A074962 001 Mar 31, 1999

200MG/20ML (10MG/ML)

N206426 001 Dec 19, 2014

2MG

4MG

6MG

8MG

10MG

12MG

N202834
N202834
N202834
N202834
N202834
N202834

6.52MG/ML

N021064 001 Jul 31, 2001

2MG

4MG

8MG

N020184 001 Dec 30, 1993

N020184 002 Dec 30, 1993

N020184 003 Dec 30, 1993

2MG

4MG

8MG

2MG

4MG

8MG

2MG

4MG

8MG

2MG

4MG

8MG

2MG

4MG

8MG

A078138
A078138
A078138
A090463
A090463
A090463
A079070
A079070
A079070
A078263
A078263
A078263
A090072
A090072
A090072

5%

N019855 001 Aug 25, 1989

5%

5%

A074806 001 Jan 23, 1998

A076369 001 Apr 21, 2003

001
002
003
004
005
006

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Oct
Oct
Oct
Oct
Oct
Oct

Nov
Nov
Nov
Aug
Aug
Aug
Nov
Nov
Nov
Jan
Jan
Jan
Nov
Nov
Nov

22,
22,
22,
22,
22,
22,

10,
10,
10,
30,
30,
30,
10,
10,
10,
27,
27,
27,
10,
10,
10,

2012

2012

2012

2012

2012

2012

2009

2009

2009

2010

2010

2010

2009

2009

2009

2010

2010

2010

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-302(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PERPHENAZINE

TABLET;ORAL

PERPHENAZINE

AB
INDICUS PHARMA
AB
AB
AB
AB
SANDOZ
AB
AB
AB
+
AB
VINTAGE PHARMS
AB
AB
AB

2MG
4MG
8MG
16MG
2MG
4MG
8MG
16MG
2MG
4MG
8MG
16MG

PHENDIMETRAZINE TARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

PHENDIMETRAZINE TARTRATE

+ SANDOZ
105MG
TABLET;ORAL

BONTRIL PDM

AA
+ VALEANT
35MG
PHENDIMETRAZINE TARTRATE

AA
ELITE LABS INC
35MG
AA
KVK TECH
35MG
AA
MIKART
35MG
AA
SANDOZ
35MG
PHENELZINE SULFATE

TABLET;ORAL

NARDIL

AB
+ PARKE DAVIS
PHENELZINE SULFATE

AB
NOVEL LABS INC

001
002
003
004
001
001
001
001
001
002
003
004

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

17,
17,
17,
17,
08,
08,
08,
08,
31,
31,
31,
31,

2015

2015

2015

2015

1988

1988

1988

1988

1998

1998

1998

1998

N018074 001

A085272 001

A040762
A091042
A089452
A085588

001 Jan 28, 2008

001 Aug 31, 2010

001 Oct 30, 1991

001

EQ 15MG BASE

N011909 002

EQ 15MG BASE

A200181 001 Dec 08, 2010

PHENOXYBENZAMINE HYDROCHLORIDE

CAPSULE;ORAL

DIBENZYLINE

AB
+ CONCORDIA PHARMS INC
10MG
PHENOXYBENZAMINE HYDROCHLORIDE

AB
ROXANE
10MG
PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL

ADIPEX-P

AA
+ TEVA
PHENTERMINE HYDROCHLORIDE

AA
BARR
AA
AA
ELITE LABS
AA
AA
INVAGEN PHARMS
AA
AA
AA
AA
KEN LIFESCIENCE
AA
AA
AA
KVK TECH
AA
AA
AA
AA
LANNETT
AA
AA
AA
LANNETT HOLDINGS INC
AA
MIKAH PHARMA LLC
AA
MUTUAL PHARM
AA
+ SANDOZ
AA
+
AA
+

A205973
A205973
A205973
A205973
A089683
A089684
A089685
A089686
A040226
A040226
A040226
A040226

N008708 001

A201050 001 Jul 16, 2012

37.5MG

A088023 001 Aug 02, 1983

15MG
30MG
15MG
30MG
15MG
30MG
30MG
37.5MG
15MG
30MG
37.5MG
15MG
30MG
30MG
37.5MG
15MG
30MG
30MG
37.5MG
37.5MG
30MG
15MG
30MG
30MG

A090591
A090591
A202248
A202248
A202858
A202858
A204414
A202846
A205019
A205019
A205017
A040886
A040875
A040886
A040887
A087022
A087022
A091359
A201961
A040228
A040525
A087190
A086945
A087190

001
002
001
002
001
002
001
001
001
002
001
002
001
001
001
002
001
001
001
001
001
002

001
001

Mar
Mar
Sep
Sep
Feb
Feb
May
Feb
Dec
Dec
Sep
Mar
Mar
Mar
Apr
Jan
Feb
Jul
Jul
Jun
Oct

18,
18,
28,
28,
14,
14,
05,
05,
05,
05,
25,
31,
21,
31,
24,
20,
03,
16,
20,
19,
23,

2010

2010

2012

2012

2014

2014

2014

2014

2014

2014

2014

2008

2008

2008

2008

2012

1983

2010

2011

1997

2003

Jul 20, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-303(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PHENTERMINE HYDROCHLORIDE

TABLET;ORAL

ADIPEX-P

AA
+ TEVA
37.5MG
PHENTERMINE HYDROCHLORIDE

AA
AUROLIFE PHARMA LLC
37.5MG
AA
BARR
37.5MG
AA
ELITE LABS
37.5MG
AA
INVAGEN PHARMS
37.5MG
AA
KEN LIFESCIENCE
37.5MG
AA
KVK TECH
37.5MG
AA
LANNETT
37.5MG
AA
MIKAH PHARMA
37.5MG
AA
MIRROR PHARMS
37.5MG
AA
MUTUAL PHARM
37.5MG
AA
SUN PHARM INDS INC
37.5MG
AA
VINTAGE PHARMS
37.5MG
TABLET, ORALLY DISINTEGRATING;ORAL

SUPRENZA

CITIUS PHARMS
15MG
30MG
+
37.5MG

A085128 001

A203068
A090470
A200272
A202942
A205008
A040876
A040555
A040190
A091451
A040526
A040790
A040377

001
001
001
001
001
001
001
001
001
001
001
001

Aug
Aug
Jan
Feb
Sep
Mar
Apr
May
Sep
Oct
Aug
Jan

06,
31,
31,
05,
25,
31,
15,
30,
21,
23,
21,
04,

2014

2009

2011

2014

2014

2008

2005

1997

2012

2003

2007

2002

N202088 001 Jun 13, 2011

N202088 002 Jun 13, 2011

N202088 003 Mar 27, 2012

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

CAPSULE, EXTENDED RELEASE;ORAL

QSYMIA

VIVUS
EQ 3.75MG BASE;23MG
EQ 7.5MG BASE;46MG
EQ 11.25MG BASE;69MG
+
EQ 15MG BASE;92MG

N022580
N022580
N022580
N022580

PHENTERMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE;ORAL

PHENTERMINE RESIN COMPLEX

+ LANNETT HOLDINGS INC
EQ 15MG BASE
+
EQ 30MG BASE

A040872 001 Jul 28, 2011

A040872 002 Jul 28, 2011

PHENTOLAMINE MESYLATE

INJECTABLE;INJECTION

PHENTOLAMINE MESYLATE

AP
EUROHLTH INTL SARL
REGITINE

AP
+ NOVARTIS
ORAVERSE

+ SEPTODONT HOLDING

001
002
003
004

Jul
Jul
Jul
Jul

17,
17,
17,
17,

2012

2012

2012

2012

5MG/VIAL

A040235 001 Mar 11, 1998

5MG/VIAL

N008278 003

0.4MG/1.7ML

N022159 001 May 09, 2008

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION;IV (INFUSION)

PHENYLEPHRINE HYDROCHLORIDE

+ WEST WARD PHARM CORP
10MG/ML (10MG/ML)
VAZCULEP

ECLAT PHARMS LLC
10MG/ML (10MG/ML)
50MG/5ML (10MG/ML)
+
100MG/10ML (10MG/ML)
SOLUTION/DROPS;OPHTHALMIC

PHENYLEPHRINE HYDROCHLORIDE

+ AKORN INC
2.5%
+
10%
+ PARAGON BIOTECK
2.5%
+
10%
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

AA
HI-TECH PHARMACAL
5MG/5ML;6.25MG/5ML
AA
VINTAGE
5MG/5ML;6.25MG/5ML
PROMETH VC PLAIN

AA
+ G AND W LABS INC
5MG/5ML;6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

AA
AMNEAL PHARMS
5MG/5ML;6.25MG/5ML

N203826 001 Dec 20, 2012

N204300 001 Jun 27, 2014

N204300 002 Jun 27, 2014

N204300 003 Jun 27, 2014

N207926
N207926
N203510
N203510

001
002
001
002

Jan
Jan
Mar
Mar

15,
15,
21,
21,

2015

2015

2013

2013

A040675 001 Dec 23, 2014

A040654 001 Dec 07, 2006

A088761 001 Nov 08, 1984

A040902 001 Aug 25, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-304(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PHENYTOIN

SUSPENSION;ORAL

DILANTIN-125

AB
+ PARKE DAVIS
PHENYTOIN

AB
TARO
AB
VISTAPHARM
AB
AB
WOCKHARDT
TABLET, CHEWABLE;ORAL

DILANTIN

AB
+ PFIZER PHARMS
PHENYTOIN

AB
COREPHARMA
AB
MYLAN PHARMS INC
AB
TARO
PHENYTOIN SODIUM

CAPSULE;ORAL

DILANTIN

AB
+ PARKE DAVIS
AB
+
EXTENDED PHENYTOIN SODIUM

AB
AMNEAL PHARMS NY
AB
MYLAN
AB
SUN PHARM INDS
AB
AB
SUN PHARM INDS (IN)
AB
TARO
PHENYTEK

AB
MYLAN
AB
+
PHENYTOIN SODIUM

AB
AUROBINDO PHARMA LTD
INJECTABLE;INJECTION

PHENYTOIN SODIUM

AP
+ EUROHLTH INTL SARL
AP
HOSPIRA
AP
LUITPOLD
AP
X-GEN PHARMS
PHYTONADIONE

INJECTABLE;INJECTION

PHYTONADIONE

BP
+ INTL MEDICATION
VITAMIN K1

BP
+ HOSPIRA
+
TABLET;ORAL

MEPHYTON

+ VALEANT PHARMS
PILOCARPINE HYDROCHLORIDE

SOLUTION;OPHTHALMIC

ISOPTO CARPINE

ALCON RES
+
TABLET;ORAL

PILOCARPINE HYDROCHLORIDE

AB
ELAN PHARMA INTL LTD
AB
IMPAX LABS
AB
AB
LANNETT
AB
AB
ROXANE
AB
SALAGEN

AB
EISAI INC
AB
+

125MG/5ML

N008762 001

125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML

A040521
A040342
A040610
A040420

50MG

A084427 001

50MG
50MG
50MG

A040884 001 Nov 28, 2014

A200691 001 Dec 26, 2012

A200565 001 Apr 17, 2014

30MG EXTENDED
100MG EXTENDED

A084349 001

A084349 002

100MG
100MG
200MG
300MG
100MG
100MG

A040765
A040298
A040731
A040731
A040621
A040684

EXTENDED
EXTENDED
EXTENDED
EXTENDED
EXTENDED
EXTENDED

001
001
001
001

001
001
001
002
001
001

Mar
Jan
Aug
Apr

Nov
Dec
Jun
Jun
Dec
Sep

08,
31,
18,
19,

12,
28,
30,
30,
11,
05,

2004

2001

2005

2002

2008

1998

2008

2008

2006

2006

200MG EXTENDED
300MG EXTENDED

A040298 002 Dec 06, 2001

A040298 003 Dec 06, 2001

100MG EXTENDED

A204309 001 Jun 10, 2015

50MG/ML
50MG/ML
50MG/ML
50MG/ML

A084307
A089521
A040781
A040573

1MG/0.5ML

A083722 001

1MG/0.5ML
10MG/ML

A087954 001 Jul 25, 1983

A087955 001 Jul 25, 1983

5MG

N010104 003

1%
2%
4%

N200890 001 Jun 22, 2010

N200890 002 Jun 22, 2010

N200890 003 Jun 22, 2010

5MG
5MG
7.5MG
5MG
7.5MG
5MG
7.5MG

A076746
A077248
A077248
A077220
A077220
A076963
A076963

5MG
7.5MG

N020237 001 Mar 22, 1994

N020237 002 Apr 18, 2003

001

001 Mar 17, 1987

001 Dec 04, 2007

001 Sep 13, 2006

001
001
002
001
002
001
002

Nov
Mar
Mar
Oct
May
Dec
Feb

16,
31,
31,
14,
06,
22,
27,

2004

2006

2006

2005

2009

2004

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-305(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PIMECROLIMUS

CREAM;TOPICAL

ELIDEL

+ VALEANT BERMUDA

1%

N021302 001 Dec 13, 2001

PIMOZIDE

TABLET;ORAL

ORAP

AB
TEVA
AB
+
PIMOZIDE

AB
PAR PHARM
AB

1MG
2MG

N017473 003 Aug 27, 1997

N017473 001 Jul 31, 1984

1MG
2MG

A204521 001 Sep 28, 2015

A204521 002 Sep 28, 2015

PINDOLOL

TABLET;ORAL

PINDOLOL

AB
MUTUAL PHARM
AB
AB
MYLAN PHARMS INC
AB
+
AB
NOSTRUM LABS INC
AB

5MG
10MG
5MG
10MG
5MG
10MG

A074063
A074063
A074019
A074019
A205415
A205415

EQ 15MG BASE
EQ 30MG BASE
EQ 45MG BASE

N021073 001 Jul 15, 1999

N021073 002 Jul 15, 1999

N021073 003 Jul 15, 1999

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A200044
A200044
A200044
A200268
A200268
A200268
A078472
A078472
A078472
A078383
A078383
A078383
A204133
A204133
A204133
A202467
A202467
A202467
A076801
A076801
A076801
A078670
A078670
A078670
A077210
A077210
A077210
A091298
A091298
A091298
A076798
A076798
A076798
A202456
A202456
A202456

PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

ACTOS

AB
TAKEDA PHARMS USA
AB
AB
+
PIOGLITAZONE HYDROCHLORIDE

AB
ACCORD HLTHCARE
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
BRECKENRIDGE PHARM
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
LUPIN LTD
AB
AB
AB
MACLEODS PHARMS LTD
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA PHARMS USA
AB
AB
AB
TORRENT PHARMS LTD
AB
AB
AB
WATSON LABS
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB

15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
001
002
001
002

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jan
Jan
Sep
Sep
Jan
Jan

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Apr
Apr
Apr
Feb
Feb
Feb
Aug
Aug
Aug
Feb
Feb
Feb
Jan
Jan
Jan
Feb
Feb
Feb
Oct
Oct
Oct
Feb
Feb
Feb

27,
27,
03,
03,
13,
13,

13,
13,
13,
13,
13,
13,
13,
13,
13,
12,
12,
12,
07,
07,
07,
06,
06,
06,
17,
17,
17,
13,
13,
13,
10,
10,
10,
13,
13,
13,
26,
26,
26,
13,
13,
13,

1994

1994

1992

1992

2016

2016

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2013

2014

2014

2014

2013

2013

2013

2012

2012

2012

2013

2013

2013

2014

2014

2014

2013

2013

2013

2012

2012

2012

2013

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-306(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PIPERACILLIN SODIUM

INJECTABLE;INJECTION

PIPERACILLIN

+ ISTITUTO BIO ITA SPA
+
+
+

EQ
EQ
EQ
EQ

2GM BASE/VIAL
3GM BASE/VIAL
4GM BASE/VIAL
40GM BASE/VIAL

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

INJECTABLE;INJECTION

PIPERACILLIN AND TAZOBACTAM

AP
AUROBINDO PHARMA LTD
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
AP
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
AP
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
HOSPIRA INC
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
AP
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
AP
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
AP
ISTITUTO BIO ITA SPA
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
AP
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
AP
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
AP
MYLAN LABS LTD
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
AP
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
AP
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
SANDOZ
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
AP
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
AP
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
AP
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
AP
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
ZOSYN

AP
+ WYETH PHARMS INC
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
AP
+
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
AP
+
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
AP
+
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
ZOSYN IN PLASTIC CONTAINER

+ WYETH PHARMS INC
EQ 40MG BASE/ML;EQ 5MG BASE/ML
+
EQ 60MG BASE/ML;EQ 7.5MG BASE/ML
+
EQ 4GM BASE/100ML;EQ 500MG BASE/100ML
INJECTABLE;IV (INFUSION)

PIPERACILLIN AND TAZOBACTAM

SANDOZ INC
EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL
PIRFENIDONE

CAPSULE;ORAL

ESBRIET

+ GENENTECH INC
PIROXICAM

CAPSULE;ORAL

FELDENE

AB
PFIZER
AB
+
PIROXICAM

AB
MUTUAL PHARM
AB
MYLAN
AB
AB
MYLAN PHARMS INC
AB
AB
TEVA
AB
PITAVASTATIN CALCIUM

TABLET;ORAL

LIVALO

KOWA CO
+

A065114
A065114
A065114
A065157

001
002
003
001

Nov
Nov
Nov
Jul

14,
14,
14,
12,

2003

2003

2003

2004

A065498
A065498
A065498
A065386
A065386
A065386
A065446
A065523
A065523
A065523
A090498
A065458
A065458
A065458
A065362
A065363
A065362
A065363
A065362
A065363

001
002
003
001
002
003
001
001
002
003
001
001
002
003
001
001
002
002
003
003

May
May
May
Sep
Sep
Sep
Sep
May
May
May
May
Aug
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct

23,
23,
23,
15,
15,
15,
15,
31,
31,
31,
31,
15,
15,
15,
21,
21,
21,
21,
21,
21,

2011

2011

2011

2009

2009

2009

2009

2011

2011

2011

2011

2014

2014

2014

2010

2010

2010

2010

2010

2010

N050684
N050684
N050684
N050684

001
002
003
004

Oct
Oct
Oct
Oct

22,
22,
22,
22,

1993

1993

1993

1993

N050750 001 Feb 24, 1998

N050750 002 Feb 24, 1998

N050750 003 Feb 24, 1998

A203557 001 Oct 29, 2014

267MG

N022535 001 Oct 15, 2014

10MG
20MG

N018147 002 Apr 06, 1982

N018147 003 Apr 06, 1982

10MG
10MG
20MG
10MG
20MG
10MG
20MG

A073535
A074102
A074102
A074116
A074118
A074131
A074131

EQ 1MG BASE
EQ 2MG BASE
EQ 4MG BASE

N022363 001 Aug 03, 2009

N022363 002 Aug 03, 2009

N022363 003 Aug 03, 2009

001
001
002
001
001
001
002

Mar
Jul
Jul
Jun
Jun
Dec
Dec

12,
31,
31,
15,
15,
11,
11,

1993

1992

1992

1993

1993

1992

1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

PLERIXAFOR

SOLUTION;SUBCUTANEOUS

MOZOBIL

+ GENZYME
PODOFILOX

GEL;TOPICAL

CONDYLOX

+ ACTAVIS LABS UT INC
SOLUTION;TOPICAL

CONDYLOX

AT
+ ACTAVIS LABS UT INC
PODOFILOX

AT
BAUSCH AND LOMB INC
AT
PADDOCK LLC
POLIDOCANOL

SOLUTION;INTRAVENOUS

ASCLERA

CHEMISCH FBRK KRSSLR
+
VARITHENA

+ PROVENSIS
POLYETHYLENE GLYCOL 3350

FOR SOLUTION;ORAL

GLYCOLAX

AA
KREMERS URBAN PHARMS
POLYETHYLENE GLYCOL 3350

AA
BRECKENRIDGE PHARM
AA
NEXGEN PHARMA INC
AA
PADDOCK LLC

3-307(of 388)

24MG/1.2ML (20MG/ML)

N022311 001 Dec 15, 2008

0.5%

N020529 001 Mar 13, 1997

0.5%

N019795 001 Dec 13, 1990

0.5%
0.5%

A090184 001 Jul 21, 2010

A075600 001 Jan 29, 2002

10MG/2ML (5MG/ML)
20MG/2ML (10MG/ML)

N021201 001 Mar 30, 2010

N021201 002 Mar 30, 2010

180MG/18ML (10MG/ML)

N205098 001 Nov 25, 2013

17GM/SCOOPFUL

A076652 001 Jul 02, 2004

17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL

A077736 001 May 26, 2006

A077706 001 Sep 27, 2006

A077893 001 May 26, 2006

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FOR SOLUTION;ORAL

LAX-LYTE WITH FLAVOR PACKS

AA
PADDOCK LLC
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
A079232 001 Feb 25, 2010

BOT

NULYTELY

AA
+ BRAINTREE
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
N019797 001 Apr 22, 1991

BOT

NULYTELY-FLAVORED

AA
+ BRAINTREE
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
N019797 002 Nov 18, 1994

BOT

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

AA
MYLAN
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
A090409 001 Apr 02, 2010

BOT

AA
NOVEL LABS INC
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
A090019 001 May 27, 2009

BOT

AA
STRIDES ARCOLAB LTD
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
A204559 001 Apr 13, 2015

BOT

TRILYTE

AA
MEDA PHARMS
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
A076491 001 Feb 05, 2004

BOT

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM
ANHYDROUS

FOR SOLUTION;ORAL

GOLYTELY

AA
+ BRAINTREE
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
N019011 001 Jul
BOT;22.74GM/BOT

PEG 3350 AND ELECTROLYTES

AA
MYLAN
236GM;2.97GM;6.74GM;5.86GM;22.74GM
A090928 001 Jan
AA
NOVEL LABS INC
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
A090231 001 Jun
BOT;22.74GM/BOT

AA
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
A090186 001 Jun
BOT;22.72GM/BOT

COLYTE

MEDA PHARMS
227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G
N018983 010 Jan
M/BOT;21.5GM/BOT

COLYTE WITH FLAVOR PACKS

MEDA PHARMS
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
N018983 012 Oct
BOT;22.72GM/BOT

GOLYTELY

+ BRAINTREE
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC
N019011 002 Jun
KET;5.53GM/PACKET;21.5GM/PACKET

SULFATE

13, 1984

28, 2010

01, 2009

01, 2009

31, 1989

08, 1998

02, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-308(of 388)

PRESCRIPTION DRUG PRODUCT LIST

POLYMYXIN B SULFATE

INJECTABLE;INJECTION

POLYMYCIN B SULFATE

AP
SAGENT STRIDES

POLYMYXIN B SULFATE

AP
+ EUROHLTH INTL SARL
AP
FRESENIUS KABI USA
AP
X GEN PHARMS
AP
XELLIA PHARMS APS

EQ 500,000 UNITS BASE/VIAL

A090110 001 Jun 29, 2011

EQ
EQ
EQ
EQ

A060716
A065372
A063000
A202766

500,000
500,000
500,000
500,000

UNITS
UNITS
UNITS
UNITS

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

SOLUTION/DROPS;OPHTHALMIC

POLYTRIM

AT
+ ALLERGAN
10,000 UNITS/ML;EQ
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

AT
AKORN INC
10,000 UNITS/ML;EQ
AT
ALCON RES LTD
10,000 UNITS/ML;EQ
AT
BAUSCH AND LOMB
10,000 UNITS/ML;EQ
POMALIDOMIDE

CAPSULE;ORAL

POMALYST

CELGENE

001

001 Jan 10, 2008

001 Sep 30, 1994

001 Jan 15, 2014

1MG BASE/ML

N050567 001 Oct 20, 1988

1MG BASE/ML

1MG BASE/ML

1MG BASE/ML

A065006 001 Dec 17, 1998

A064211 001 Apr 13, 1998

A064120 001 Feb 14, 1997

1MG

2MG

3MG

4MG

N204026
N204026
N204026
N204026

EQ 15MG BASE

EQ 30MG BASE

EQ 45MG BASE

N203469 001 Dec 14, 2012

N203469 003 Apr 23, 2015

N203469 002 Dec 14, 2012

PORACTANT ALFA

SUSPENSION;INTRATRACHEAL

CUROSURF

+ CHIESI USA INC

80MG/ML

N020744 001 Nov 18, 1999

PORFIMER SODIUM

INJECTABLE;INJECTION

PHOTOFRIN

CONCORDIA LABS INC

75MG/VIAL

N020451 001 Dec 27, 1995

+

PONATINIB HYDROCHLORIDE

TABLET;ORAL

ICLUSIG

ARIAD

+

POSACONAZOLE

SOLUTION;IV (INFUSION)

NOXAFIL

+ MERCK SHARP DOHME

300MG/16.7ML (18MG/ML)

SUSPENSION;ORAL

NOXAFIL

+ SCHERING

40MG/ML

TABLET, DELAYED RELEASE;ORAL

NOXAFIL

+ MERCK SHARP DOHME

100MG

POTASSIUM ACETATE

INJECTABLE;INJECTION

POTASSIUM ACETATE

AP
EXELA PHARMA SCS LLC

AP
+ HOSPIRA

2MEQ/ML

2MEQ/ML

POTASSIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

KLOR-CON

AB
UPSHER SMITH

8MEQ

AB

10MEQ

MICRO-K

AB
NESHER PHARMS

8MEQ

MICRO-K 10

AB
NESHER PHARMS

10MEQ

POTASSIUM CHLORIDE

AB
ACTAVIS LABS FL INC

8MEQ

AB
+

10MEQ

AB
AMNEAL PHARMS

10MEQ

AB
ANCHEN PHARMS

8MEQ

AB

10MEQ

001
002
003
004

Feb
Feb
Feb
Feb

08,
08,
08,
08,

2013

2013

2013

2013

N205596 001 Mar 13, 2014

N022003 001 Sep 15, 2006

N205053 001 Nov 25, 2013

A206203 001 Dec 29, 2015

N018896 001 Jul 20, 1984

A203106 001 Jul 10, 2015

A203106 002 Jul 10, 2015

N018238 001

N018238 002 May 14, 1984

A077419
A077419
A202128
A202886
A202886

001
002
001
001
002

Jun
Jun
Feb
Dec
Dec

02,
02,
22,
26,
26,

2008

2008

2013

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-309(of 388)

PRESCRIPTION DRUG PRODUCT LIST

POTASSIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

POTASSIUM CHLORIDE

AB
LUPIN LTD
8MEQ
AB
10MEQ
AB
PADDOCK LLC
8MEQ
AB
10MEQ
AB
PHARMACEUTICS INTL
8MEQ
AB
10MEQ
FOR SOLUTION;ORAL

POTASSIUM CHLORIDE

PHARMA RES SOFTWARE
20MEQ
INJECTABLE;INJECTION

POTASSIUM CHLORIDE

AP
B BRAUN
2MEQ/ML
AP
BAXTER HLTHCARE
2MEQ/ML
AP
FRESENIUS KABI USA
2MEQ/ML
AP
+ HOSPIRA
2MEQ/ML
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
14.9MG/ML
AP
+
746MG/100ML
AP
HOSPIRA
14.9MG/ML
AP
745MG/100ML
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
29.8MG/ML
AP
+
1.49GM/100ML
AP
+ HOSPIRA
29.8MG/ML
AP
1.49GM/100ML
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
2.24GM/100ML
AP
+ HOSPIRA
2.24GM/100ML
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
2.98GM/100ML
AP
+ HOSPIRA
2.98GM/100ML
POTASSIUM CHLORIDE IN PLASTIC CONTAINER

AP
FRESENIUS KABI USA
2MEQ/ML
AP
2MEQ/ML
POTASSIUM CHLORIDE

+ FRESENIUS KABI USA
3MEQ/ML
SOLUTION;ORAL

POTASSIUM CHLORIDE

PHARMA-MED INC
20MEQ/15ML
+
40MEQ/15ML
TABLET, EXTENDED RELEASE;ORAL

KLOR-CON M10

AB1
UPSHER SMITH LABS
10MEQ
KLOR-CON M20

AB1 + UPSHER SMITH LABS
20MEQ
POTASSIUM CHLORIDE

AB1
ACTAVIS LABS FL INC
10MEQ
AB1
20MEQ
AB1
ADARE PHARMS INC
20MEQ
KLOR-CON

AB2
UPSHER-SMITH LABS
8MEQ
AB2 +
10MEQ
POTASSIUM CHLORIDE

AB2
MYLAN PHARMS INC
8MEQ
AB2
10MEQ
AB2
PADDOCK LLC
8MEQ
AB2
10MEQ
K-TAB

BC
ABBVIE
8MEQ
BC
10MEQ
BC
+
20MEQ
KLOR-CON M15

UPSHER SMITH LABS
15MEQ

A203002
A203002
A200185
A200185
A205549
A205549

001
002
001
002
001
002

Dec
Dec
May
May
Dec
Dec

18,
18,
18,
18,
08,
08,

2015

2015

2011

2011

2015

2015

N208019 001 Aug 19, 2015

A085870
A085499
A080225
A080205

001

001

001

001

N019904
N019904
N020161
N020161

001
005
005
001

Dec
Dec
Nov
Nov

26,
17,
30,
30,

1989

1990

1992

1992

N019904
N019904
N020161
N020161

002
006
006
002

Dec
Dec
Aug
Nov

26,
17,
11,
30,

1989

1990

1998

1992

N019904 003 Dec 26, 1989

N020161 003 Aug 11, 1998

N019904 004 Dec 26, 1989

N020161 004 Aug 11, 1998

A088901 001 Jan 25, 1985

A088908 001 Jan 25, 1985

A080225 003

N206814 001 Dec 22, 2014

N206814 002 Dec 22, 2014

A074726 002 Aug 09, 2000

A074726 001 Nov 20, 1998

A075604 001 Apr 10, 2002

A075604 002 Apr 10, 2002

A076368 001 Aug 18, 2004

N019123 001 Apr 17, 1986

N019123 002 Apr 17, 1986

A204662
A204662
A205993
A205993

001
002
001
002

Aug
Aug
Nov
Nov

21,
21,
05,
05,

2014

2014

2015

2015

N018279 002 Aug 01, 1988

N018279 001

N018279 003 Nov 25, 2013

A074726 003 Jun 06, 2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-310(of 388)

PRESCRIPTION DRUG PRODUCT LIST

POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

AP
HOSPIRA
149MG/100ML;450MG/100ML
A078446
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

AP
+ BAXTER HLTHCARE
150MG/100ML;450MG/100ML
N017648
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
B BRAUN
150MG/100ML;900MG/100ML
N019708
AP
BAXTER HLTHCARE
150MG/100ML;900MG/100ML
N017648
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
BAXTER HLTHCARE
300MG/100ML;900MG/100ML
N017648
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
HOSPIRA
149MG/100ML;900MG/100ML
N019686
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
HOSPIRA
298MG/100ML;900MG/100ML
N019686
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%

BAXTER HLTHCARE
224MG/100ML;900MG/100ML
N017648

001 Sep 10, 2008

005 Nov 26, 2002

004 Sep 29, 1989

001

002

001 Oct 17, 1988

002 Oct 17, 1988

003

POTASSIUM CITRATE

TABLET, EXTENDED RELEASE;ORAL

POTASSIUM CITRATE

AB
COREPHARMA
5MEQ
AB
10MEQ
AB
ZYDUS PHARMS USA INC
5MEQ
AB
10MEQ
AB
15MEQ
UROCIT-K

AB
MISSION PHARMA
5MEQ
AB
10MEQ
AB
+
15MEQ

N019071 001 Aug 30, 1985

N019071 002 Aug 31, 1992

N019071 003 Dec 30, 2009

POVIDONE-IODINE

SOLUTION/DROPS;OPHTHALMIC

BETADINE

+ ALCON PHARMS LTD

5%

N018634 001 Dec 17, 1986

PRALATREXATE

SOLUTION;INTRAVENOUS

FOLOTYN

ALLOS
+

20MG/ML (20MG/ML)
40MG/2ML (20MG/ML)

N022468 001 Sep 24, 2009

N022468 002 Sep 24, 2009

300MG/ML

N018986 001 Apr 26, 1983

1GM/VIAL

N014134 001

PRALIDOXIME CHLORIDE

INJECTABLE;INJECTION

PRALIDOXIME CHLORIDE

+ MERIDIAN MEDCL TECHN
PROTOPAM CHLORIDE

+ BAXTER HLTHCARE CORP

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET;ORAL

MIRAPEX

AB
BOEHRINGER INGELHEIM
0.125MG
AB
+
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
PRAMIPEXOLE DIHYDROCHLORIDE

AB
ACTAVIS GRP PTC
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
ALEMBIC LTD
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
1.5MG
AB
APOTEX INC
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG

A077440
A077440
A203546
A203546
A203546

001
002
001
002
003

Jun
Jun
Aug
Aug
Aug

09,
09,
06,
06,
06,

2006

2006

2014

2014

2014

N020667
N020667
N020667
N020667
N020667
N020667

001
002
006
007
003
005

Jul
Jul
Feb
Jul
Jul
Jul

01,
01,
12,
30,
01,
01,

1997

1997

1998

2007

1997

1997

A091254
A091254
A091254
A091254
A091254
A091254
A078894
A078894
A078894
A078894
A078894
A090151
A090151
A090151
A090151
A090151

001
002
003
004
005
006
001
002
003
004
005
001
002
003
006
004

Nov
Nov
Nov
Nov
Nov
Nov
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr

30,
30,
30,
30,
30,
30,
08,
08,
08,
08,
08,
30,
30,
30,
30,
30,

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-311(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET;ORAL

PRAMIPEXOLE DIHYDROCHLORIDE

AB
1.5MG
AB
AUROBINDO PHARMA LTD
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
BARR
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
1.5MG
AB
BRECKENRIDGE PHARM
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
1.5MG
AB
GLENMARK GENERICS
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
MACLEODS PHARMS LTD
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
1.5MG
AB
MYLAN
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
SANDOZ
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
SCIEGEN PHARMS INC
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
STRIDES PHARMA
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
SUN PHARM INDS INC
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
TEVA PHARMS
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
AB
TORRENT PHARMS
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG

A090151
A202633
A202633
A202633
A202633
A202633
A202633
A077724
A077724
A077724
A077724
A077724
A091450
A091450
A091450
A091450
A091450
A090781
A090781
A090781
A090781
A090781
A090781
A202164
A202164
A202164
A202164
A202164
A077854
A077854
A077854
A090764
A077854
A077854
A090190
A090190
A090190
A090190
A090190
A090190
A203855
A203855
A203855
A203855
A203855
A203855
A202702
A202702
A202702
A202702
A202702
A202702
A091683
A091683
A091683
A091683
A091683
A091683
A090241
A090241
A090241
A090241
A090241
A090241
A090865
A090865
A090865
A090865
A090865

005
001
002
003
004
005
006
001
002
003
004
005
001
002
003
004
005
001
002
003
006
004
005
001
002
003
004
005
001
002
003
001
004
005
001
002
003
006
004
005
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005

Apr
Oct
Oct
Oct
Oct
Oct
Oct
Feb
Feb
Feb
Feb
Feb
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Sep
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Apr
Oct
Oct
Jul
Jul
Jul
Oct
Jul
Jul
Oct
Oct
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Mar
Mar
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

30,
26,
26,
26,
26,
26,
26,
19,
19,
19,
19,
19,
08,
08,
08,
08,
08,
08,
08,
08,
11,
08,
08,
20,
20,
20,
20,
20,
08,
08,
08,
09,
08,
08,
06,
06,
06,
08,
06,
06,
28,
28,
28,
28,
28,
28,
03,
03,
03,
03,
03,
03,
27,
27,
27,
27,
27,
27,
08,
08,
08,
08,
08,
08,
08,
08,
08,
08,
08,

2012

2012

2012

2012

2012

2012

2012

2008

2008

2008

2008

2008

2010

2010

2010

2010

2010

2010

2010

2010

2015

2010

2010

2012

2012

2012

2012

2012

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2013

2013

2013

2013

2013

2013

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-312(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET;ORAL

PRAMIPEXOLE DIHYDROCHLORIDE

AB

1.5MG

AB
ZYDUS PHARMS USA INC
0.125MG

AB

0.25MG

AB

0.5MG

AB

1MG

AB

1.5MG

TABLET, DELAYED RELEASE;ORAL

PRAMIPEXOLE DIHYDROCHLORIDE

AB
SANDOZ INC

0.375MG

AB

0.75MG

AB

1.5MG

AB

3MG

AB

4.5MG

TABLET, EXTENDED RELEASE;ORAL

MIRAPEX ER

AB
+ BOEHRINGER INGELHEIM
0.375MG

AB

0.75MG

AB

1.5MG

AB

2.25MG

AB

3MG

AB

3.75MG

AB

4.5MG

PRAMIPEXOLE DIHYDROCHLORIDE

AB
ANCHEN PHARMS

0.375MG

AB

0.75MG

AB

1.5MG

AB

2.25MG

AB

3MG

AB

3.75MG

AB

4.5MG

AB
DR REDDYS LABS LTD

0.375MG

AB

0.75MG

AB

1.5MG

AB

3MG

AB

4.5MG

A090865
A078920
A078920
A078920
A078920
A078920

006
001
002
003
004
005

Oct
Jul
Jul
Jul
Jul
Jul

08,
06,
06,
06,
06,
06,

2010

2010

2010

2010

2010

2010

A202353
A202353
A202353
A202353
A202353

001
002
003
004
005

Dec
Dec
Dec
Dec
Dec

04,
04,
04,
04,
04,

2014

2014

2014

2014

2014

N022421
N022421
N022421
N022421
N022421
N022421
N022421

001
002
003
006
004
007
005

Feb
Feb
Feb
Jun
Feb
Jun
Feb

19,
19,
19,
17,
19,
17,
19,

2010

2010

2010

2011

2010

2011

2010

A202206
A202206
A202206
A202206
A202206
A202206
A202206
A203354
A203354
A203354
A203354
A203354

001
002
003
004
005
006
007
001
002
003
004
005

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Aug
Aug
Aug
Aug
Aug

06,
06,
06,
06,
06,
06,
06,
07,
07,
07,
07,
07,

2014

2014

2014

2014

2014

2014

2014

2015

2015

2015

2015

2015

PRAMLINTIDE ACETATE

INJECTABLE;SUBCUTANEOUS

SYMLIN

ASTRAZENECA AB

+

EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)

EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)

N021332 002 Sep 25, 2007

N021332 003 Sep 25, 2007

PRASUGREL HYDROCHLORIDE

TABLET;ORAL

EFFIENT

ELI LILLY AND CO

+

EQ 5MG BASE

EQ 10MG BASE

N022307 001 Jul 10, 2009

N022307 002 Jul 10, 2009

20MG

40MG

80MG

N019898 003 Oct 31, 1991

N019898 004 Mar 22, 1993

N019898 008 Dec 18, 2001

10MG

20MG

40MG

80MG

10MG

20MG

40MG

10MG

20MG

40MG

80MG

10MG

20MG

40MG

80MG

10MG

A076341
A076341
A076341
A076341
A077904
A077904
A077904
A076714
A076714
A076714
A076714
A077987
A077987
A077987
A077987
A077917

PRAVASTATIN SODIUM

TABLET;ORAL

PRAVACHOL

AB
BRISTOL MYERS SQUIBB

AB

AB
+

PRAVASTATIN SODIUM

AB
APOTEX

AB

AB

AB

AB
CIPLA LTD

AB

AB

AB
DR REDDYS LABS INC

AB

AB

AB

AB
GLENMARK GENERICS

AB

AB

AB

AB
LUPIN PHARMS

001
002
003
004
001
002
003
001
002
003
004
001
002
003
004
001

Oct
Oct
Oct
Dec
Oct
Oct
Oct
Oct
Oct
Oct
Dec
May
May
May
Dec
Jan

23,
23,
23,
28,
23,
23,
23,
23,
23,
23,
28,
11,
11,
11,
28,
08,

2006

2006

2006

2007

2006

2006

2006

2006

2006

2006

2007

2007

2007

2007

2007

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-313(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PRAVASTATIN SODIUM

TABLET;ORAL

PRAVASTATIN SODIUM

AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
TEVA
AB
AB
AB
TEVA PHARMS
AB
WATSON LABS
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB

20MG

40MG

80MG

10MG

20MG

40MG

80MG

10MG

20MG

40MG

80MG

10MG

20MG

40MG

80MG

10MG

20MG

40MG

80MG

10MG

20MG

40MG

80MG

10MG

20MG

40MG

80MG

A077917
A077917
A077917
A077013
A077013
A077013
A077013
A079187
A079187
A079187
A079187
A076397
A076397
A076397
A077491
A076056
A076056
A076056
A077793
A076939
A076939
A076939
A076939
A077751
A077751
A077751
A077751

PRAZIQUANTEL

TABLET;ORAL

BILTRICIDE

+ BAYER HLTHCARE

600MG

N018714 001 Dec 29, 1982

EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

N017442 002

N017442 003

N017442 001

EQ
EQ
EQ
EQ
EQ
EQ

A071994
A072575
A072575
A072575
A071995
A071745

PRAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

MINIPRESS

AB
PFIZER
AB
+
AB
PRAZOSIN HYDROCHLORIDE

AB
IVAX SUB TEVA PHARMS
AB
MYLAN
AB
AB
AB
TEVA PHARMS
AB
PREDNICARBATE

CREAM;TOPICAL

DERMATOP E EMOLLIENT

AB
+ VALEANT BERMUDA
PREDNICARBATE

AB
FOUGERA PHARMS
OINTMENT;TOPICAL

DERMATOP

AB
+ VALEANT PHARMS NORTH
PREDNICARBATE

AB
FOUGERA PHARMS
PREDNISOLONE

SYRUP;ORAL

PREDNISOLONE

AA
ALPHARMA
AA
+ HI TECH PHARMA CO
AA
PHARM ASSOC
AA
VINTAGE
AA
WOCKHARDT
PRELONE

AA
TEVA

1MG
1MG
2MG
5MG
2MG
5MG

BASE

BASE

BASE

BASE

BASE

BASE

002
003
004
001
002
003
004
001
002
003
004
003
002
001
001
001
002
003
001
004
003
002
001
001
002
003
004

001
003
002
001
001
001

Jan
Jan
Jan
Oct
Oct
Oct
Dec
May
May
May
May
Oct
Oct
Oct
Feb
Apr
Apr
Apr
Jan
Oct
Oct
Oct
Dec
Apr
Apr
Apr
Apr

Sep
May
May
May
Sep
Sep

08,
08,
08,
23,
23,
23,
28,
27,
27,
27,
27,
23,
23,
23,
11,
24,
24,
24,
15,
23,
23,
23,
28,
30,
30,
30,
30,

12,
16,
16,
16,
12,
12,

2008

2008

2008

2006

2006

2006

2007

2010

2010

2010

2010

2006

2006

2006

2008

2006

2006

2006

2008

2006

2006

2006

2007

2008

2008

2008

2008

1988

1989

1989

1989

1988

1988

0.1%

N020279 001 Oct 29, 1993

0.1%

A077287 001 Sep 19, 2006

0.1%

N019568 001 Sep 23, 1991

0.1%

A077236 001 Mar 09, 2007

15MG/5ML

15MG/5ML

15MG/5ML

15MG/5ML

15MG/5ML

A040323
A040401
A040399
A040775
A040313

15MG/5ML

A089081 001 Feb 04, 1986

001
001
001
001
001

May
Feb
Mar
Sep
Sep

13,
27,
05,
21,
10,

1999

2003

2003

2007

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-314(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PREDNISOLONE

TABLET;ORAL

PREDNISOLONE

+ WATSON LABS
PREDNISOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC

OMNIPRED

AB
ALCON
PRED FORTE

AB
+ ALLERGAN
PRED MILD

+ ALLERGAN

5MG

A080354 001

1%

N017469 001

1%

N017011 001

0.12%

N017100 001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

OINTMENT;OPHTHALMIC

BLEPHAMIDE S.O.P.

+ ALLERGAN
0.2%;10%
SUSPENSION;OPHTHALMIC

BLEPHAMIDE

+ ALLERGAN
0.2%;10%

A087748 001 Dec 03, 1986

N012813 002

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION;ORAL

ORAPRED

AA
+ CONCORDIA PHARMS INC
EQ 15MG BASE/5ML
PEDIAPRED

AA
+ SETON PHARM
EQ 5MG BASE/5ML
PREDNISOLONE SODIUM PHOSPHATE

AA
AMNEAL PHARMS
EQ 15MG BASE/5ML
AA
HI TECH PHARMA
EQ 5MG BASE/5ML
AA
PADDOCK LLC
EQ 5MG BASE/5ML
AA
PHARM ASSOC
EQ 15MG BASE/5ML
AA
VINTAGE
EQ 15MG BASE/5ML
AA
WOCKHARDT
EQ 5MG BASE/5ML
AA
EQ 15MG BASE/5ML
+ MISSION PHARMA
EQ 25MG BASE/5ML
+ PHARM ASSOC
EQ 10MG BASE/5ML
+
EQ 20MG BASE/5ML
SOLUTION/DROPS;OPHTHALMIC

PREDNISOLONE SODIUM PHOSPHATE

+ BAUSCH AND LOMB
EQ 0.9% PHOSPHATE
TABLET, ORALLY DISINTEGRATING;ORAL

ORAPRED ODT

AB
CONCORDIA PHARMS INC
EQ 10MG BASE
AB
EQ 15MG BASE
AB
+
EQ 30MG BASE
PREDNISOLONE SODIUM PHOSPHATE

AB
MYLAN PHARMS INC
EQ 10MG BASE
AB
EQ 15MG BASE
AB
EQ 30MG BASE

A202179 001 Apr 10, 2013

A202179 002 Apr 10, 2013

A202179 003 Apr 10, 2013

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE

AT
ALCON PHARMS LTD
EQ 0.23% PHOSPHATE;10%
AT
+ BAUSCH AND LOMB
EQ 0.23% PHOSPHATE;10%

A073630 001 May 27, 1993

A074449 001 Dec 29, 1995

PREDNISONE
SOLUTION;ORAL
PREDNISONE
+ ROXANE
PREDNISONE INTENSOL
+ ROXANE
TABLET;ORAL
PREDNISONE
AB
CONTRACT PHARMACAL
AB
HIKMA PHARMS
AB
AB
AB
AB
AB
JUBILANT CADISTA
AB
AB

A075117 001 Dec 14, 2000

N019157 001 May 28, 1986

A078345
A075183
A075988
A076913
A079010
A075099
A076895
A091396
A078465
A078988

001
001
001
001
001
001
001
001
001
001

Mar
Mar
May
Apr
May
Jun
Oct
Sep
Mar
Jun

10,
26,
25,
25,
26,
28,
04,
13,
07,
09,

2009

2003

2004

2005

2009

2002

2004

2010

2008

2008

A040070 001 Jul 29, 1994

N021959 001 Jun 01, 2006

N021959 002 Jun 01, 2006

N021959 003 Jun 01, 2006

5MG/5ML

A088703 001 Nov 08, 1984

5MG/ML

A088810 001 Feb 20, 1985

5MG
2.5MG
5MG
10MG
20MG
50MG
1MG
5MG
10MG

A080209
A040538
A080292
A088832
A083677
A088465
A040611
A040362
A040362

001
001
001
001
001
001
001
002
001

Jan 08, 2004

Dec 04, 1985
Jun
Jun
Aug
Aug

01,
06,
29,
29,

1984
2005
2001
2001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-315(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PREDNISONE

TABLET;ORAL

PREDNISONE

AB
AB
MUTUAL PHARM
AB
AB
AB
+ ROXANE
AB
+
AB
+
AB
+
AB
+
AB
+
AB
VINTAGE PHARMS
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
TABLET, DELAYED RELEASE;ORAL

RAYOS

HORIZON PHARMA
+
PREGABALIN

CAPSULE;ORAL

LYRICA

PF PRISM CV

+
SOLUTION;ORAL

LYRICA

+ PF PRISM CV
PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

PRILOCAINE HYDROCHLORIDE

+ SEPTODONT INC
PRIMAQUINE PHOSPHATE

TABLET;ORAL

PRIMAQUINE

AB
+ SANOFI AVENTIS US
PRIMAQUINE PHOSPHATE

AB
ALVOGEN INC
AB
BAYSHORE PHARMS LLC
PRIMIDONE

TABLET;ORAL

MYSOLINE

AB
+ VALEANT
AB
PRIMIDONE

AB
AMNEAL PHARM
AB
AB
HIKMA PHARMS LLC
AB
IMPAX LABS
AB
AB
LANNETT
AB
AB
MUTUAL PHARM
AB
AB
VINTAGE PHARMS
AB
AB
WATSON LABS

20MG
5MG
10MG
20MG
1MG
2.5MG
5MG
10MG
20MG
50MG
1MG
2.5MG
5MG
10MG
20MG
5MG
10MG
20MG

A040362
A089245
A089246
A089247
A087800
A087801
A080352
A084122
A087342
A084283
A040584
A040581
A040256
A040256
A040392
A080356
A085162
A085161

003
001
001
001
001
001
001

001

001

001

001
001
001
002
001
001

001

001

1MG
2MG
5MG

N202020 001 Jul 26, 2012

N202020 002 Jul 26, 2012

N202020 003 Jul 26, 2012

25MG
50MG
75MG
100MG
150MG
200MG
225MG
300MG

N021446
N021446
N021446
N021446
N021446
N021446
N021446
N021446

20MG/ML

N022488 001 Jan 04, 2010

4%

A079235 001 Sep 29, 2010

EQ 15MG BASE

N008316 001

EQ 15MG BASE
EQ 15MG BASE

A203924 001 Feb 03, 2014

A204476 001 Feb 25, 2014

50MG
250MG

N009170 003

N009170 002

50MG
250MG
250MG
50MG
250MG
50MG
250MG
50MG
250MG
50MG
250MG
250MG

A040866
A040866
A040667
A040717
A040717
A084903
A084903
A040626
A040626
A040586
A040586
A083551

001
002
003
004
005
006
007
008

001
002
002
001
002
002
001

001
002
001
002
001

Jun
Dec
Dec
Dec
Apr
Apr

29,
04,
04,
04,
22,
22,

2005

1985

1985

1985

1982

1982

Dec
Dec
Jul
Jul
Feb

21,
21,
12,
12,
12,

2004

2004

2002

2002

2003

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

30,
30,
30,
30,
30,
30,
30,
30,

2004

2004

2004

2004

2004

2004

2004

2004

Apr
Apr
Jul
Feb
Feb
May

23,
23,
27,
12,
12,
24,

2008

2008

2006

2008

2008

2001

Sep
Sep
Feb
Feb

29,
29,
24,
24,

2005

2005

2005

2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-316(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PROBENECID

TABLET;ORAL

PROBALAN

AB
LANNETT
PROBENECID

AB
+ MYLAN
AB
WATSON LABS

500MG

A080966 001

500MG
500MG

A084211 002

A084442 004 Mar 29, 1983

PROCAINAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

PROCAINAMIDE HYDROCHLORIDE

+ HOSPIRA
100MG/ML
+
500MG/ML

A089069 001 Feb 12, 1986

A089070 001 Feb 12, 1986

PROCARBAZINE HYDROCHLORIDE

CAPSULE;ORAL

MATULANE

+ SIGMA TAU

EQ 50MG BASE

N016785 001

25MG

A040246 001 Jun 28, 2000

25MG

A040058 001 Nov 24, 1993

PROCHLORPERAZINE

SUPPOSITORY;RECTAL

COMPRO

AB
PADDOCK LLC
PROCHLORPERAZINE

AB
+ G AND W LABS

PROCHLORPERAZINE EDISYLATE

INJECTABLE;INJECTION

PROCHLORPERAZINE EDISYLATE

AP
BEDFORD
EQ 5MG BASE/ML
AP
EMCURE PHARMS LTD
EQ 5MG BASE/ML
AP
+ EUROHLTH INTL SARL
EQ 5MG BASE/ML
PROCHLORPERAZINE MALEATE

TABLET;ORAL

PROCHLORPERAZINE MALEATE

AB
MYLAN
AB
AB
SANDOZ
AB
+
AB
TEVA PHARMS
AB
PROCOMP

AB
JUBILANT CADISTA
AB
PROGESTERONE

CAPSULE;ORAL

PROGESTERONE

AB
BANNER LIFE SCIENCES
AB
AB
SOFGEN PHARMS
AB
AB
TEVA PHARMS
AB
PROMETRIUM

AB
ABBVIE INC
AB
+
GEL;VAGINAL

CRINONE

+ ACTAVIS LABS UT INC
+
INJECTABLE;INJECTION

PROGESTERONE

AO
+ ACTAVIS LABS UT INC
AO
FRESENIUS KABI USA
AO
HIKMA FARMACEUTICA
AO
LUITPOLD
INSERT;VAGINAL

ENDOMETRIN

+ FERRING

EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
5MG BASE
10MG BASE
5MG BASE
10MG BASE

A040540 001 May 28, 2004

A204147 001 Oct 15, 2013

A089903 001 Aug 29, 1989

A040185
A040185
A040101
A040101
A040120
A040120

002
001
001
002
001
002

Oct
Oct
Jul
Jul
Jul
Jul

28,
28,
19,
19,
11,
11,

1996

1996

1996

1996

1996

1996

EQ 5MG BASE
EQ 10MG BASE

A040268 001 Feb 27, 1998

A040268 002 Feb 27, 1998

100MG
200MG
100MG
200MG
100MG
200MG

A200900
A200900
A200456
A200456
A202121
A202121

100MG
200MG

N019781 001 May 14, 1998

N019781 002 Oct 15, 1999

4%
8%

N020701 001 Jul 31, 1997

N020701 002 Jul 31, 1997

50MG/ML
50MG/ML
50MG/ML
50MG/ML

N017362
A075906
A091033
A090845

100MG

N022057 001 Jun 21, 2007

001
002
001
002
001
002

Aug
Aug
Sep
Sep
Feb
Feb

16,
16,
28,
28,
29,
29,

2013

2013

2012

2012

2012

2012

002

001 Apr 25, 2001

001 Oct 28, 2010

001 Jun 22, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-317(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

PROMETHAZINE HYDROCHLORIDE

AP
+ EUROHLTH INTL SARL
AP
+
AP
X-GEN PHARMS
AP
SUPPOSITORY;RECTAL

PROMETHAZINE HYDROCHLORIDE

AB
G AND W LABS
AB
+
AB
PERRIGO NEW YORK
AB
AB
TARO
AB
AB
WATSON LABS INC
AB
PROMETHEGAN

+ G AND W LABS
SYRUP;ORAL

PROMETHAZINE HYDROCHLORIDE

AA
AMNEAL PHARMS
AA
HI TECH PHARMA
AA
SUN PHARM INDS INC
AA
TARO
AA
TRIS PHARMA INC
AA
VINTAGE
PROMETHAZINE PLAIN

AA
+ WOCKHARDT
TABLET;ORAL

PROMETHAZINE HYDROCHLORIDE

AB
AMNEAL PHARMS NY
AB
AB
AB
HERITAGE PHARMA
AB
AB
AB
IMPAX LABS
AB
AB
AB
KVK TECH
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
+
AB
SUN PHARM INDS INC
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
WATSON LABS
AB
ZYDUS PHARMS USA
AB
AB
AB

25MG/ML
50MG/ML
25MG/ML
50MG/ML

A083312
A083312
A040737
A040737

001

002

001 Apr 24, 2008

002 Apr 24, 2008

12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG

A040428
A040428
A040500
A040500
A040603
A040603
A040479
A040479

002
001
001
002
001
002
001
002

50MG

A087165 001 Aug 14, 1987

6.25MG/5ML
6.25MG/5ML
6.25MG/5ML
6.25MG/5ML
6.25MG/5ML
6.25MG/5ML

A040882
A040026
A040891
A040718
A091675
A040643

6.25MG/5ML

A087953 001 Nov 15, 1982

12.5MG
25MG
50MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
25MG
50MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
25MG
50MG
12.5MG
25MG
50MG

A091179
A091179
A091179
A040673
A040673
A040673
A040724
A040724
A040791
A040712
A040712
A040713
A091054
A091054
A091054
A084176
A084176
A040863
A040863
A040863
A040622
A040622
A040622
A083426
A083711
A040596
A040596
A040596

001
002
003
001
002
003
001
002
001
002
001
001
001
002
003
003

001

001
002
003
001
002
003
001

001

001
002
003

Dec
Dec
Dec
Mar
Mar
Mar
Feb
Feb
May
May
Jul
Jul
Aug
Aug
Aug

13,
13,
13,
05,
05,
05,
12,
12,
20,
04,
31,
31,
30,
30,
30,

2010

2010

2010

2008

2008

2008

2008

2008

2008

2007

2006

2006

2011

2011

2011

Dec
Dec
Dec
Jul
Jul
Jul

30,
30,
30,
18,
18,
18,

2008

2008

2008

2006

2006

2006

A078540
A078540
A078540
A202688
A202688
A202688

001
002
003
001
002
003

Oct
Oct
Oct
Aug
Aug
Aug

PROPAFENONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PROPAFENONE HYDROCHLORIDE

AB
PAR PHARM
225MG
AB
325MG
AB
425MG
AB
WATSON LABS INC
225MG
AB
325MG
AB
425MG
RYTHMOL SR

AB
GLAXOSMITHKLINE LLC
225MG
AB
325MG
AB
+
425MG

001
001
001
001
001
001

Mar
Feb
Jun
Jun
Oct
Oct
Jun
Jun

Dec
Sep
Mar
Apr
Jun
Apr

31,
05,
30,
30,
26,
26,
24,
24,

30,
25,
13,
04,
28,
26,

2003

2002

2003

2003

2006

2006

2003

2003

2009

1998

2009

2007

2012

2006

Nov 18, 2005

Nov 18, 2005

Nov 18, 2005

18,
18,
18,
24,
24,
24,

2010

2010

2010

2015

2015

2015

N021416 001 Sep 04, 2003

N021416 002 Sep 04, 2003

N021416 003 Sep 04, 2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-318(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PROPAFENONE HYDROCHLORIDE

TABLET;ORAL

PROPAFENONE HYDROCHLORIDE

AB
ANI PHARMS INC
AB
AB
AB
MUTUAL PHARM
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
WATSON LABS
AB
RYTHMOL

AB
GLAXOSMITHKLINE LLC
AB
AB
+

150MG
225MG
300MG
150MG
225MG
300MG
150MG
225MG
300MG
150MG
225MG

A076550
A076550
A076550
A075998
A075998
A075998
A075938
A075938
A075938
A075203
A075203

150MG
225MG
300MG

N019151 001 Nov 27, 1989

N019151 003 Nov 20, 1992

N019151 002 Nov 27, 1989

PROPANTHELINE BROMIDE

TABLET;ORAL

PROPANTHELINE BROMIDE

+ ROXANE

15MG

A080927 002

PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

ALCAINE

AT
+ ALCON
0.5%
PROPARACAINE HYDROCHLORIDE

AT
AKORN INC
0.5%
AT
BAUSCH AND LOMB
0.5%

A080027 001

PROPOFOL

INJECTABLE;INJECTION

DIPRIVAN

AB
+ FRESENIUS KABI USA
PROPOFOL

AB
HOSPIRA
AB
TEVA PHARMS USA
AB
WATSON LABS INC

001
002
003
001
002
003
001
002
003
001
002

Apr
Apr
Apr
Nov
Nov
Nov
Oct
Oct
Oct
Oct
Oct

23,
23,
23,
29,
29,
29,
17,
17,
17,
24,
24,

2004

2004

2004

2001

2001

2001

2002

2002

2002

2000

2000

A040277 001 Mar 16, 2000

A040074 001 Sep 29, 1995

10MG/ML

N019627 002 Jun 11, 1996

10MG/ML
10MG/ML
10MG/ML

A077908 001 Mar 17, 2006

A075102 001 Jan 04, 1999

A205307 001 Dec 22, 2015

PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

INDERAL LA

AB
CRANFORD PHARMS LLC
60MG
AB
80MG
AB
120MG
AB
+
160MG
PROPRANOLOL HYDROCHLORIDE

AB
ACTAVIS ELIZABETH
60MG
AB
80MG
AB
120MG
AB
160MG
AB
MYLAN
60MG
AB
80MG
AB
120MG
AB
160MG
AB
NORTEC DEV ASSOC
60MG
AB
80MG
AB
120MG
AB
160MG
AB
RP SCHERER
60MG
AB
80MG
AB
120MG
AB
160MG
AB
UPSHER SMITH
60MG
AB
80MG
AB
120MG
AB
160MG
AB
ZYDUS PHARMS USA INC
60MG
AB
80MG
AB
120MG
AB
160MG

N018553
N018553
N018553
N018553

004
002
003
001

Mar
Apr
Apr
Apr

18,
19,
19,
19,

1987

1983

1983

1983

A078494
A078494
A078494
A078494
A078022
A078022
A078022
A078022
A078065
A078065
A078065
A078065
A078703
A078703
A078703
A078703
A078311
A078311
A078311
A078311
A090321
A090321
A090321
A090321

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Aug
Aug
Aug
Aug
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jul
Jul
Jul
Jul
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

10,
10,
10,
10,
15,
15,
15,
15,
26,
26,
26,
26,
15,
15,
15,
15,
06,
06,
06,
06,
25,
25,
25,
25,

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2011

2011

2011

2011

2009

2009

2009

2009

2011

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-319(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

INNOPRAN XL

BX
GLAXOSMITHKLINE LLC
80MG
BX
120MG
INJECTABLE;INJECTION

PROPRANOLOL HYDROCHLORIDE

AP
+ BAXTER HLTHCARE CORP
1MG/ML
AP
BEDFORD
1MG/ML
AP
FRESENIUS KABI USA
1MG/ML
AP
HIKMA FARMACEUTICA
1MG/ML
AP
SANDOZ
1MG/ML
SOLUTION;ORAL

HEMANGEOL

+ PIERRE FABRE DERMA
4.28MG/ML
PROPRANOLOL HYDROCHLORIDE

+ ROXANE
20MG/5ML
+
40MG/5ML
TABLET;ORAL

PROPRANOLOL HYDROCHLORIDE

AB
IPCA LABS LTD
10MG
AB
20MG
AB
40MG
AB
60MG
AB
80MG
AB
MYLAN
10MG
AB
20MG
AB
40MG
AB
60MG
AB
80MG
AB
NORTHSTAR HLTHCARE
10MG
AB
20MG
AB
40MG
AB
60MG
AB
80MG
AB
PLIVA
10MG
AB
20MG
AB
40MG
AB
60MG
AB
+
80MG
AB
VINTAGE PHARMS
10MG
AB
20MG
AB
40MG
AB
60MG
AB
80MG
AB
WATSON LABS
10MG
AB
20MG
AB
40MG
AB
80MG

A078955
A078955
A078955
A078955
A078955
A070213
A070213
A070213
A070213
A070213
A078213
A078213
A078213
A078213
A078213
A071972
A071973
A071974
A071975
A071976
A070217
A070218
A070219
A070220
A070221
A070175
A070176
A070177
A070178

PROPYLTHIOURACIL

TABLET;ORAL

PROPYLTHIOURACIL

BD
ACTAVIS ELIZABETH
BD
+ DAVA PHARMS INC

50MG
50MG

A080172 001

N006188 001

PROTAMINE SULFATE

INJECTABLE;INJECTION

PROTAMINE SULFATE

+ FRESENIUS KABI USA

10MG/ML

A089454 001 Apr 07, 1987

PROTRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

PROTRIPTYLINE HYDROCHLORIDE

AB
EPIC PHARMA LLC
5MG
AB
10MG
AB
ROXANE
5MG
AB
10MG
AB
SIGMAPHARM LABS LLC
5MG
AB
10MG
VIVACTIL

AB
ODYSSEY PHARMS
5MG
AB
+
10MG

N021438 001 Mar 12, 2003

N021438 002 Mar 12, 2003

N016419
A075792
A075826
A077760
A076400

001

001
001
001
001

Aug
Aug
Jan
Feb

29,
31,
31,
26,

2000

2001

2008

2003

N205410 001 Mar 14, 2014

A070979 001 May 15, 1987

A070690 001 May 15, 1987

A202220
A202220
A078913
A078913
A090462
A090462

001
002
003
004
005
002
003
001
005
004
001
002
003
004
005
001
001
001
001
001
001
001
001
001
001
001
001
001
001

001
002
001
002
001
002

Jun
Jun
Jun
Jun
Jun
Nov
Nov
Nov
Apr
Nov
Jan
Jan
Jan
Jan
Jan
Apr
Apr
Apr
Apr
Apr
Aug
Aug
Aug
Sep
Apr
May
May
May
May

Nov
Nov
Sep
Sep
May
May

02,
02,
02,
02,
02,
19,
19,
19,
08,
19,
10,
10,
10,
10,
10,
06,
06,
06,
06,
06,
01,
01,
01,
24,
14,
13,
13,
13,
13,

19,
19,
16,
16,
03,
03,

2008

2008

2008

2008

2008

1985

1985

1985

2011

1985

2008

2008

2008

2008

2008

1988

1988

1988

1988

1988

1986

1986

1986

1986

1986

1986

1986

1986

1986

2012

2012

2008

2008

2010

2010

A073644 001 Aug 24, 1995

A073645 001 Aug 24, 1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-320(of 388)

PRESCRIPTION DRUG PRODUCT LIST

PYRAZINAMIDE

TABLET;ORAL

PYRAZINAMIDE

AB
+ DAVA PHARMS INC

AB
MIKART

500MG

500MG

PYRIDOSTIGMINE BROMIDE

INJECTABLE;INJECTION

MESTINON
AP
+ VALEANT PHARM INTL
5MG/ML

REGONOL
AP
SANDOZ
5MG/ML

SYRUP;ORAL

MESTINON

+ VALEANT PHARMS

60MG/5ML

TABLET;ORAL

MESTINON

AB
+ VALEANT PHARMS LLC

60MG

PYRIDOSTIGMINE BROMIDE

AB
IMPAX LABS

60MG

AB
ZYDUS PHARMS USA INC
60MG

TABLET, EXTENDED RELEASE;ORAL

MESTINON

AB
+ VALEANT PHARMS LLC

180MG

PYRIDOSTIGMINE BROMIDE

AB
ALVOGEN INC

180MG

AB
IMPAX LABS INC

180MG

A080157 001

A081319 001 Jun 30, 1992

N009830 001

N017398 001

N015193 001

N009829 002

A040502 001 Apr 24, 2003

A205650 001 Jun 22, 2015

N011665 001

A204737 001 Jun 26, 2015

A203184 001 Sep 15, 2015

PYRIDOXINE HYDROCHLORIDE

INJECTABLE;INJECTION

PYRIDOXINE HYDROCHLORIDE

+ FRESENIUS KABI USA

100MG/ML

A080618 001

PYRIMETHAMINE

TABLET;ORAL

DARAPRIM

+ TURING PHARMS AG

25MG

N008578 001

QUETIAPINE FUMARATE

TABLET;ORAL

QUETIAPINE FUMARATE

AB
ACCORD HLTHCARE

AB

AB

AB

AB

AB

AB
ACTAVIS GRP PTC

AB

AB

AB

AB

AB

AB

AB
ALEMBIC PHARMS LTD

AB

AB

AB

AB

AB

AB
ALKEM LABS LTD

AB

AB

AB

AB

AB

AB

AB
APOTEX INC

AB

AB

AB

AB

AB

AB
AUROBINDO PHARMA LTD

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A202152
A202152
A202152
A202152
A202152
A202152
A201762
A201762
A201762
A201762
A201762
A201762
A201762
A203390
A203390
A203390
A203390
A203390
A203390
A201504
A201504
A201504
A201504
A201504
A201504
A201504
A090960
A090960
A090960
A090960
A090960
A090960
A091388

25MG BASE

50MG BASE

100MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

150MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

150MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

001
002
003
004
005
006
001
002
003
004
005
006
007
001
002
003
004
005
006
001
002
003
004
005
006
007
001
002
003
004
005
006
001

Mar
Mar
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Oct
Oct
Oct
Oct
Oct
Oct
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar
Mar
Mar
Mar

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
28,
28,
28,
28,
28,
28,
12,
12,
12,
12,
12,
12,
12,
27,
27,
27,
27,
27,
27,
27,

2012

2012

2012

2012

2012

2012

2013

2013

2013

2013

2013

2013

2013

2014

2014

2014

2014

2014

2014

2013

2013

2013

2013

2013

2013

2013

2012

2012

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-321(of 388)

PRESCRIPTION DRUG PRODUCT LIST

QUETIAPINE FUMARATE

TABLET;ORAL

QUETIAPINE FUMARATE

AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB
DR REDDYS LABS LTD

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB
JUBILANT GENERICS

EQ
AB
LUPIN LTD

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB
MYLAN PHARMS INC

EQ
AB
ROXANE

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB
SANDOZ

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB
SUN PHARMA GLOBAL

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB
TEVA PHARMS

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB
TORRENT PHARMS LTD

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
SEROQUEL

AB
+ ASTRAZENECA PHARMS
EQ
AB
EQ
AB
EQ
AB
EQ
AB
+
EQ
AB
EQ
TABLET, EXTENDED RELEASE;ORAL

SEROQUEL XR

ASTRAZENECA

EQ
EQ
+

EQ
EQ
EQ

50MG BASE

100MG BASE

150MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

150MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

25MG BASE

50MG BASE

100MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

25MG BASE

50MG BASE

100MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

150MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

150MG BASE

200MG BASE

300MG BASE

400MG BASE

25MG BASE

50MG BASE

100MG BASE

200MG BASE

300MG BASE

400MG BASE

A091388
A091388
A091388
A091388
A091388
A091388
A077380
A077380
A077380
A077380
A077380
A077380
A077380
A203150
A201109
A201109
A201109
A201109
A201109
A201109
A090323
A090120
A090749
A090749
A090749
A090749
A090749
A078679
A078679
A078679
A078679
A078679
A078679
A078679
A201190
A201190
A201190
A201190
A201190
A201190
A077745
A077745
A077745
A077745
A077745
A077745
A077745
A200363
A200363
A200363
A200363
A200363
A200363

002
003
004
005
006
007
001
002
003
004
005
006
007
001
001
002
003
004
005
006
001
001
001
002
003
004
005
001
002
003
004
005
006
007
001
002
003
004
005
006
001
002
003
004
005
006
007
001
002
003
004
005
006

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Nov
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
26,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
14,
14,
14,
14,
14,
14,
14,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2013

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

25MG BASE

50MG BASE

100MG BASE

200MG BASE

300MG BASE

400MG BASE

N020639
N020639
N020639
N020639
N020639
N020639

001
007
002
003
005
006

Sep
Oct
Sep
Sep
Jul
Oct

26,
04,
26,
26,
26,
04,

1997

2005

1997

1997

2000

2005

50MG BASE

150MG BASE

200MG BASE

300MG BASE

400MG BASE

N022047
N022047
N022047
N022047
N022047

001
005
002
003
004

May
Aug
May
May
May

17,
11,
17,
17,
17,

2007

2008

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-322(of 388)

PRESCRIPTION DRUG PRODUCT LIST

QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

ACCUPRIL

AB
PFIZER PHARMS
AB
AB
AB
+
QUINAPRIL HYDROCHLORIDE

AB
ACTAVIS LABS FL INC
AB
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
AB
LUPIN
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
AB
AB
AB
AB
AB
TEVA
AB
AB
AB

EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
20MG BASE
40MG BASE

N019885
N019885
N019885
N019885

001
002
003
004

Nov
Nov
Nov
Nov

19,
19,
19,
19,

1991

1991

1991

1991

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
20MG BASE
20MG BASE
40MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE

A076049
A076049
A076049
A076049
A202725
A202725
A202725
A202725
A078457
A078457
A078457
A078457
A077690
A077690
A077690
A077690
A076694
A076694
A076694
A076694
A076607
A090800
A076607
A090800
A076607
A090800
A076607
A090800
A075504
A075504
A075504
A075504

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004

Jan
Jan
Jan
Jan
Apr
Apr
Apr
Apr
Aug
Aug
Aug
Aug
Jun
Jun
Jun
Jun
Dec
Dec
Dec
Dec
Dec
Jun
Dec
Jun
Dec
Jun
Dec
Jun
Aug
Aug
Aug
Aug

14,
14,
14,
14,
29,
29,
29,
29,
24,
24,
24,
24,
20,
20,
20,
20,
23,
23,
23,
23,
15,
18,
15,
18,
15,
18,
15,
18,
24,
24,
24,
24,

2005

2005

2005

2005

2013

2013

2013

2013

2007

2007

2007

2007

2006

2006

2006

2006

2004

2004

2004

2004

2004

2009

2004

2009

2004

2009

2004

2009

2007

2007

2007

2007

QUINIDINE GLUCONATE

INJECTABLE;INJECTION

QUINIDINE GLUCONATE

+ LILLY
80MG/ML
TABLET, EXTENDED RELEASE;ORAL

QUINIDINE GLUCONATE

BX
+ MUTUAL PHARM
324MG
QUINIDINE SULFATE

TABLET;ORAL

QUINIDINE SULFATE

AB
MUTUAL PHARM
200MG
AB
300MG
AB
SANDOZ
200MG
AB
300MG
AB
+ WATSON LABS
200MG
AB
+
300MG
TABLET, EXTENDED RELEASE;ORAL

QUINIDINE SULFATE

+ G AND W LABS INC
300MG
QUININE SULFATE

CAPSULE;ORAL

QUALAQUIN

AB
+ MUTUAL PHARM CO INC
QUININE SULFATE

AB
AMNEAL PHARMS
AB
LUPIN LTD
AB
MYLAN PHARMS INC
AB
RICONPHARMA LLC
AB
TEVA PHARMS

N007529 002 Feb 10, 1989

A089338 001 Feb 11, 1987

A081030
A081031
A088072
A088072
A083288
A085583

001 Apr 14, 1989

001 Apr 14, 1989

002

001 Sep 26, 1983

001

001

A040045 001 Jun 30, 1994

324MG

N021799 001 Aug 12, 2005

324MG
324MG
324MG
324MG
324MG

A203729
A203112
A202581
A204372
A091661

001
001
001
001
001

Jul
Apr
Dec
Jul
Sep

15,
24,
14,
22,
28,

2015

2015

2012

2015

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-323(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RABEPRAZOLE SODIUM

CAPSULE, DELAYED RELEASE;ORAL

ACIPHEX SPRINKLE

EISAI INC
5MG
+
10MG
TABLET, DELAYED RELEASE;ORAL

ACIPHEX

AB
+ EISAI INC
20MG
RABEPRAZOLE SODIUM

AB
AMNEAL PHARMS
20MG
AB
BRECKENRIDGE PHARM
20MG
AB
DR REDDYS LABS LTD
20MG
AB
KREMERS URBAN DEV
20MG
AB
LUPIN LTD
20MG
AB
MYLAN PHARMS INC
20MG
AB
TEVA PHARMS USA
20MG
AB
TORRENT PHARMS LTD
20MG

A204179
A204237
A076824
A090678
A078964
A076885
A076822
A202376

RADIUM RA-223 DICHLORIDE

SOLUTION;INTRAVENOUS

XOFIGO

+ BAYER HLTHCARE

162mCi/6ML (27mCi/ML)

N203971 001 May 15, 2013

60MG

N020815 001 Dec 09, 1997

60MG
60MG
60MG
60MG

A204310
A090842
A078193
A200825

EQ 100MG BASE/PACKET

N205786 001 Dec 20, 2013

EQ 400MG BASE

N022145 001 Oct 12, 2007

EQ 25MG BASE
EQ 100MG BASE

N203045 001 Dec 21, 2011

N203045 002 Dec 21, 2011

8MG
8MG

A091610 001 Aug 19, 2015

A091693 001 Jul 26, 2013

8MG

N021782 001 Jul 22, 2005

1.25MG
2.5MG
5MG
10MG

N019901
N019901
N019901
N019901

001
002
003
004

Jan
Jan
Jan
Jan

28,
28,
28,
28,

1991

1991

1991

1991

1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG

A202392
A202392
A202392
A202392
A079116
A079116
A079116
A079116
A091604
A091604
A091604
A091604
A078191
A078191

001
002
003
004
001
002
003
004
001
002
003
004
001
002

Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

15,
15,
15,
15,
20,
20,
20,
20,
08,
08,
08,
08,
18,
18,

2014

2014

2014

2014

2008

2008

2008

2008

2011

2011

2011

2011

2008

2008

RALOXIFENE HYDROCHLORIDE

TABLET;ORAL

EVISTA

AB
+ LILLY
RALOXIFENE HYDROCHLORIDE

AB
AUROBINDO PHARMA LTD
AB
INVAGEN PHARMS
AB
TEVA PHARMS USA
AB
WATSON LABS INC
RALTEGRAVIR POTASSIUM

POWDER;ORAL

ISENTRESS

+ MERCK SHARP DOHME
TABLET;ORAL

ISENTRESS

+ MERCK SHARP DOHME
TABLET, CHEWABLE;ORAL

ISENTRESS

MERCK SHARP DOHME
+
RAMELTEON

TABLET;ORAL

RAMELTEON

AB
ACTAVIS LABS FL INC
AB
TEVA PHARMS USA
ROZEREM

AB
+ TAKEDA PHARMS USA
RAMIPRIL

CAPSULE;ORAL

ALTACE

AB
KING PHARMS
AB
AB
AB
+
RAMIPRIL

AB
ACCORD HLTHCARE INC
AB
AB
AB
AB
APOTEX
AB
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
AB
DR REDDYS LABS LTD
AB

N204736 001 Mar 26, 2013

N204736 002 Mar 26, 2013

N020973 002 Aug 19, 1999

001
001
001
001
001
001
001
001

001
001
001
001

Jul
Nov
Nov
Nov
Nov
Nov
Nov
Nov

Aug
Sep
Mar
Jan

31,
18,
08,
08,
08,
08,
08,
08,

28,
24,
04,
21,

2015

2015

2013

2013

2013

2013

2013

2013

2015

2014

2014

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-324(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RAMIPRIL

CAPSULE;ORAL

RAMIPRIL
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
AB
LUPIN
AB
AB
AB
AB
ROXANE
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
TEVA PHARMS
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
TABLET;ORAL

RAMIPRIL

APOTEX INC

+

RANITIDINE HYDROCHLORIDE

CAPSULE;ORAL

RANITIDINE HYDROCHLORIDE
AB
DR REDDYS LABS LTD
AB
AB
SANDOZ
AB
+
INJECTABLE;INJECTION

RANITIDINE HYDROCHLORIDE

AP
EUROHLTH INTL SARL

AP

AP
ZYDUS PHARMS USA INC

ZANTAC

AP
+ CONCORDIA PHARMS INC

SYRUP;ORAL

RANITIDINE HYDROCHLORIDE

AA
ACTAVIS MID ATLANTIC

AA
AMNEAL PHARMS

AA
AUROBINDO PHARM

AA
BIO PHARM INC

AA
BRECKENRIDGE PHARM

AA
CARACO

AA
HI TECH PHARMA

AA
PHARM ASSOC

AA
SILARX

AA
TARO

AA
TOLMAR

AA
VINTAGE PHARMS

AA
WOCKHARDT

AA

ZANTAC

AA
+ GLAXO GRP LTD

5MG

10MG

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

10MG

A078191
A078191
A078745
A078745
A078745
A078745
A077626
A077626
A077626
A077626
A077900
A077900
A077900
A077900
A077514
A077514
A077514
A077514
A077470
A077470
A077470
A077470
A076549
A076549
A076549
A076549
A078832
A078832
A078832
A078832

003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep

18,
18,
18,
18,
18,
18,
09,
09,
09,
09,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
24,
24,
24,
24,
02,
02,
02,
02,

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2005

2005

2005

2005

2008

2008

2008

2008

1.25MG

2.5MG

5MG

10MG

A091069
A091069
A091069
A091069

001
002
003
004

Dec
Dec
Dec
Dec

02,
02,
02,
02,

2015

2015

2015

2015

A075742
A075742
A074655
A074655

001
002
001
002

Nov
Nov
Oct
Oct

29,
29,
22,
22,

2000

2000

1997

1997

EQ
EQ
EQ
EQ

150MG
300MG
150MG
300MG

BASE

BASE

BASE

BASE

EQ 25MG BASE/ML

EQ 25MG BASE/ML

25MG/ML

A074777 001 Mar 02, 2005

A077458 001 Feb 16, 2006

A091534 001 Feb 22, 2013

EQ 25MG BASE/ML

N019090 001 Oct 19, 1984

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A076124
A078312
A090623
A090102
A078684
A091091
A091078
A077405
A091288
A077476
A090054
A078890
A079211
A079212

15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

EQ 15MG BASE/ML

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Feb
Sep
Jul
May
Aug
Sep
Mar
Sep
Dec
Jun
Nov
Jul
May
Feb

21,
02,
28,
26,
27,
20,
22,
21,
09,
13,
15,
01,
26,
23,

2007

2008

2010

2009

2009

2011

2011

2007

2010

2011

2010

2010

2009

2009

N019675 001 Dec 30, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-325(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RANITIDINE HYDROCHLORIDE

TABLET;ORAL

RANITIDINE HYDROCHLORIDE

AB
AMNEAL PHARMS NY

AB

AB
APOTEX

AB

AB
DR REDDYS LABS INC

AB

AB
GLENMARK GENERICS

AB

AB
IVAX SUB TEVA PHARMS

AB

AB
MYLAN

AB

AB
PAR PHARM

AB

AB
SANDOZ

AB

AB
TEVA

AB

AB
WOCKHARDT

AB

ZANTAC 150

AB
GLAXO GRP LTD

ZANTAC 300

AB
+ GLAXO GRP LTD

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A077824
A077824
A074680
A074680
A076705
A076705
A078542
A078542
A075165
A075165
A074023
A074023
A075180
A075180
A074467
A074467
A074488
A074488
A075208
A075208

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Oct
Oct
Sep
Sep
Jul
Jul
Nov
Nov
Sep
Sep
Aug
Aug
Jan
Jan
Aug
Aug
Jul
Jul
Dec
Dec

13,
13,
12,
12,
27,
27,
19,
19,
30,
30,
22,
22,
28,
28,
29,
29,
31,
31,
17,
17,

2006

2006

1997

1997

2005

2005

2008

2008

1998

1998

1997

1997

1999

1999

1997

1997

1997

1997

1998

1998

EQ 150MG BASE

N018703 001 Jun 09, 1983

EQ 300MG BASE

N018703 002 Dec 09, 1985

RANOLAZINE

TABLET, EXTENDED RELEASE;ORAL

RANEXA

AB
GILEAD

500MG

AB
+

1GM

RANOLAZINE

AB
LUPIN LTD

500MG

AB

1GM

N021526 002 Jan 27, 2006

N021526 001 Feb 12, 2007

RASAGILINE MESYLATE

TABLET;ORAL

AZILECT

AB
TEVA

AB
+

RASAGILINE MESYLATE

AB
APOTEX INC

AB

EQ 0.5MG BASE

EQ 1MG BASE

N021641 001 May 16, 2006

N021641 002 May 16, 2006

EQ 0.5MG BASE

EQ 1MG BASE

A201950 001 Sep 12, 2013

A201950 002 Sep 12, 2013

REGADENOSON

SOLUTION;INTRAVENOUS

LEXISCAN

+ ASTELLAS

0.4MG/5ML (0.08MG/ML)

N022161 001 Apr 10, 2008

REGORAFENIB

TABLET;ORAL

STIVARGA

+ BAYER HLTHCARE

40MG

N203085 001 Sep 27, 2012

EQ 1MG BASE/VIAL

EQ 2MG BASE/VIAL

EQ 5MG BASE/VIAL

N020630 001 Jul 12, 1996

N020630 002 Jul 12, 1996

N020630 003 Jul 12, 1996

0.5MG

1MG

2MG

N020741 001 Dec 22, 1997

N020741 002 Dec 22, 1997

N020741 003 Dec 22, 1997

0.5MG

1MG

2MG

0.5MG

1MG

A090008
A090008
A090008
A203820
A203820

REMIFENTANIL HYDROCHLORIDE

INJECTABLE;INJECTION

ULTIVA

MYLAN INSTITUTIONAL

+

REPAGLINIDE

TABLET;ORAL

PRANDIN

AB
NOVO NORDISK INC

AB

AB
+

REPAGLINIDE

AB
ACTAVIS TOTOWA

AB

AB

AB
AUROBINDO PHARMA LTD

AB

A201046 001 Jul 29, 2013

A201046 002 Jul 29, 2013

001
002
003
001
002

Jan
Jan
Jan
Jan
Jan

22,
22,
22,
22,
22,

2014

2014

2014

2014

2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-326(of 388)

PRESCRIPTION DRUG PRODUCT LIST

REPAGLINIDE

TABLET;ORAL

REPAGLINIDE

AB

AB
MYLAN PHARMS INC

AB

AB

AB
PADDOCK LLC

AB

AB

AB
SANDOZ INC

AB

AB

AB
STANDARD CHEM PHARM

AB

AB

AB
SUN PHARM INDS INC

AB

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

0.5MG

1MG

2MG

1MG

2MG

A203820
A090252
A090252
A090252
A201189
A201189
A201189
A078555
A078555
A078555
A091517
A091517
A091517
A077571
A077571

RESERPINE

TABLET;ORAL

RESERPINE

BP
SANDOZ

BP
+

0.1MG

0.25MG

N009838 001

N009838 002

RETAPAMULIN

OINTMENT;TOPICAL

ALTABAX

+ GLAXO GRP LTD

1%

N022055 001 Apr 12, 2007

200MG

N020903 002 Jul 25, 2001

200MG

A076203 001 Apr 06, 2004

200MG

A079117 001 Sep 17, 2009

200MG

200MG

200MG

A076192 001 Apr 06, 2004

A076277 001 Oct 04, 2004

A077224 001 Oct 28, 2005

6GM/VIAL

N018859 001 Dec 31, 1985

40MG/ML

N021546 001 Jul 29, 2003

200MG

N021511 001 Dec 03, 2002

200MG

200MG

200MG

400MG

500MG

600MG

200MG

200MG

400MG

600MG

200MG

400MG

500MG

600MG

A079111
A077743
A202546
A202546
A202546
A202546
A077053
A077456
A077456
A077456
A077094
A077094
A077094
A077094

150MG

N050689 001 Dec 23, 1992

150MG

A090033 001 Feb 24, 2014

RIBAVIRIN

CAPSULE;ORAL

REBETOL

AB
+ MERCK SHARP DOHME

RIBASPHERE

AB
THREE RIVERS PHARMS

RIBAVARIN

AB
AUROBINDO PHARMA

RIBAVIRIN

AB
SANDOZ

AB
TEVA

AB
ZYDUS PHARMS USA

FOR SOLUTION;INHALATION

VIRAZOLE

+ VALEANT PHARM INTL

SOLUTION;ORAL

REBETOL

+ SCHERING

TABLET;ORAL

COPEGUS

AB
ROCHE

RIBAVIRIN

AB
AUROBINDO PHARMA
AB
SANDOZ
AB
SANDOZ INC
AB
AB
AB
AB
TEVA
AB
THREE RIVERS PHARMS
AB
AB
+
AB
ZYDUS PHARMS USA
AB
AB
AB
RIFABUTIN

CAPSULE;ORAL

MYCOBUTIN

AB
+ PHARMACIA AND UPJOHN

RIFABUTIN

AB
LUPIN LTD

003
001
002
003
001
002
003
001
002
003
001
002
003
002
003

001
001
001
002
003
004
001
001
002
003
001
002
004
003

Jan
Aug
Jan
Jan
Jul
Jan
Jan
Nov
Jan
Jan
Apr
Apr
Apr
Jul
Jul

Sep
Oct
Aug
Aug
Aug
Aug
Dec
Dec
Dec
Dec
Dec
Mar
Apr
Mar

22,
23,
22,
22,
17,
22,
22,
22,
22,
22,
24,
24,
24,
11,
11,

17,
03,
12,
12,
12,
12,
05,
05,
05,
05,
05,
16,
18,
16,

2014

2013

2014

2014

2013

2014

2014

2013

2014

2014

2015

2015

2015

2013

2013

2009

2006

2014

2014

2014

2014

2005

2005

2005

2005

2005

2007

2008

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-327(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RIFAMPIN

CAPSULE;ORAL

RIFADIN

AB
SANOFI AVENTIS US
AB
+
RIFAMPIN

AB
LANNETT
AB
AB
LUPIN PHARMS
AB
AB
SANDOZ
AB
AB
VERSAPHARM
AB
RIMACTANE

AB
PROSAM LABS
INJECTABLE;INJECTION

RIFADIN

AP
+ SANOFI AVENTIS US
RIFAMPIN

AP
BEDFORD
AP
EMCURE PHARMS LTD
AP
FRESENIUS KABI USA
AP
MYLAN LABS LTD
AP
VERSAPHARM INC

150MG
300MG

A062303 001

N050420 001

150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG

A065390
A065390
A090034
A090034
A064150
A064150
A065028
A065028

300MG

N050429 001

600MG/VIAL

N050627 001 May 25, 1989

600MG/VIAL
600MG/VIAL
600MG/VIAL
600MG/VIAL
600MG/VIAL

A064217
A204101
A091181
A065421
A065502

RIFAPENTINE

TABLET;ORAL

PRIFTIN

+ SANOFI AVENTIS US

150MG

N021024 001 Jun 22, 1998

RIFAXIMIN

TABLET;ORAL

XIFAXAN

+ SALIX PHARMS
+

200MG
550MG

N021361 001 May 25, 2004

N022554 001 Mar 24, 2010

RILPIVIRINE HYDROCHLORIDE

TABLET;ORAL

EDURANT

+ JANSSEN PRODS

EQ 25MG BASE

N202022 001 May 20, 2011

50MG

N020599 001 Dec 12, 1995

50MG
50MG
50MG
50MG
50MG

A091300
A091394
A076173
A203042
A091417

RILUZOLE

TABLET;ORAL

RILUTEK

AB
+ COVIS PHARMA SARL
RILUZOLE

AB
APOTEX CORP
AB
GLENMARK GENERICS
AB
IMPAX LABS
AB
MYLAN PHARMS INC
AB
SUN PHARM INDS LTD

001
002
001
002
002
001
001
002

001
001
001
001
001

001
001
001
001
001

Mar
Mar
Aug
Aug
Jan
May
Mar
Mar

Oct
Aug
Aug
May
Sep

Jun
Jun
Jan
Jul
Jun

28,
28,
21,
21,
02,
28,
14,
14,

29,
18,
21,
22,
21,

18,
18,
29,
01,
18,

2008

2008

2013

2013

1998

1997

2001

2001

1999

2014

2014

2008

2010

2013

2013

2003

2013

2013

RIMANTADINE HYDROCHLORIDE

TABLET;ORAL

FLUMADINE

AB
+ CARACO
RIMANTADINE HYDROCHLORIDE

AB
IMPAX LABS

100MG

N019649 001 Sep 17, 1993

100MG

A076132 001 Aug 30, 2002

RIMEXOLONE

SUSPENSION/DROPS;OPHTHALMIC

VEXOL

+ ALCON

1%

N020474 001 Dec 30, 1994

0.5MG
1MG
1.5MG
2MG
2.5MG

N204819
N204819
N204819
N204819
N204819

RIOCIGUAT

TABLET;ORAL

ADEMPAS

BAYER HLTHCARE

001
002
003
004
005

Oct
Oct
Oct
Oct
Oct

08,
08,
08,
08,
08,

2013

2013

2013

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-328(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RISEDRONATE SODIUM

TABLET;ORAL

ACTONEL

AB
WARNER CHILCOTT LLC
AB
AB
+
AB
+
RISEDRONATE SODIUM

AB
APOTEX INC
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
MACLEODS PHARMS LTD
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
AB
SUN PHARMA GLOBAL
AB
AB
AB
AB
AB
TEVA PHARMS USA
AB
AB
AB
TABLET, DELAYED RELEASE;ORAL

ATELVIA

AB
+ WARNER CHILCOTT LLC
RISEDRONATE SODIUM

AB
TEVA PHARMS USA
RISPERIDONE

INJECTABLE;INTRAMUSCULAR

RISPERDAL CONSTA

JANSSEN PHARMS
+

SOLUTION;ORAL

RISPERDAL

AA
+ JANSSEN PHARMS
RISPERIDONE

AA
AMNEAL PHARMS
AA
ANI PHARMS INC
AA
APOTEX INC
AA
AUROBINDO PHARMA
AA
BIO PHARM INC
AA
PRECISION DOSE
AA
ROXANE
AA
SILARX PHARMS INC
AA
TARO
AA
TRIS PHARMA INC
AA
VINTAGE
WOCKHARDT
AA
TABLET;ORAL

RISPERDAL

AB
JANSSEN PHARMS
AB
AB
+
AB
AB
AB
RISPERIDONE

AB
AJANTA PHARMA LTD
AB
AB
AB
AB

5MG
30MG
35MG
150MG

N020835
N020835
N020835
N020835

002
001
003
005

Apr
Mar
May
Apr

14,
27,
25,
22,

2000

1998

2002

2008

35MG
75MG
150MG
5MG
30MG
35MG
5MG
30MG
5MG
30MG
35MG
75MG
150MG
5MG
30MG
35MG
75MG
150MG
5MG
30MG
35MG
150MG

A090877
A090877
A090877
A200296
A200296
A200296
A203533
A203533
A200477
A200477
A200477
A200477
A200477
A090886
A090886
A090886
A090886
A090886
A077132
A077132
A077132
A079215

001
002
003
001
002
003
001
002
001
002
003
004
005
001
002
003
004
005
001
002
003
001

Nov
Jun
Jun
Nov
Nov
Nov
Dec
Dec
Nov
Nov
Nov
Jun
Jun
Nov
Nov
Nov
Jun
Jun
Oct
Oct
Oct
Jun

30,
10,
10,
30,
30,
30,
09,
09,
30,
30,
30,
10,
10,
30,
30,
30,
10,
10,
05,
05,
05,
13,

2015

2014

2014

2015

2015

2015

2015

2015

2015

2015

2015

2014

2014

2015

2015

2015

2014

2014

2007

2007

2007

2014

35MG

N022560 001 Oct 08, 2010

35MG

A203217 001 May 18, 2015

12.5MG/VIAL
25MG/VIAL
37.5MG/VIAL
50MG/VIAL

N021346
N021346
N021346
N021346

1MG/ML

N020588 001 Jun 10, 1996

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML

A091384
A076440
A077719
A078452
A078909
A076797
A076904
A202386
A090347
A079059
A079158
A078744

001
001
001
001
001
001
001
001
001
001
001
001

May
Jan
Jul
Sep
Jul
Jun
Jul
Jan
Feb
Dec
Dec
Oct

25,
30,
29,
04,
29,
28,
29,
12,
07,
12,
03,
08,

2011

2009

2009

2009

2009

2010

2009

2015

2011

2012

2010

2009

0.25MG
0.5MG
1MG
2MG
3MG
4MG

N020272
N020272
N020272
N020272
N020272
N020272

008
007
001
002
003
004

May
Jan
Dec
Dec
Dec
Dec

10,
27,
29,
29,
29,
29,

1999

1999

1993

1993

1993

1993

0.25MG
0.5MG
1MG
2MG
3MG

A201003
A201003
A201003
A201003
A201003

001
002
003
004
005

Aug
Aug
Aug
Aug
Aug

24,
24,
24,
24,
24,

2011

2011

2011

2011

2011

004
001
002
003

Apr
Oct
Oct
Oct

12,
29,
29,
29,

2007

2003

2003

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-329(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RISPERIDONE

TABLET;ORAL

RISPERIDONE

AB
AB
APOTEX INC
AB
AB
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
AB
AB
CIPLA
AB
AB
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
PLIVA HRVATSKA DOO
AB
AB
AB
AB
AB
AB
PRINSTON INC
AB
AB
AB
AB
AB
AB
PROSAM LABS
AB
AB
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
AB
AB
SUN PHARM INDS INC
AB
AB
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
AB
AB
TORRENT PHARMS
AB

4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG

A201003
A077953
A077953
A077953
A077953
A077953
A077953
A078269
A078269
A078269
A078269
A078269
A078269
A077543
A077543
A077543
A077543
A077543
A077543
A076879
A076879
A076879
A076879
A076879
A076879
A076288
A076288
A076288
A076288
A076288
A076288
A077769
A077769
A077769
A077769
A077769
A077769
A077493
A077493
A077493
A077493
A077493
A077493
A078071
A078071
A078071
A078071
A078071
A078071
A078528
A078528
A078528
A078528
A078528
A078528
A078036
A078036
A078036
A078036
A078036
A078036
A076228
A076228
A076228
A076228
A076228
A076228
A079088
A079088

006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002

Aug
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Oct
Oct
Oct
May
May
May
May
May
May
Oct
Oct
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Oct
Oct
Oct
Nov
Nov
Nov
Nov
Nov
Nov
Jun
Jun
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Oct
Mar
Mar
Mar
Mar
Mar
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Oct
Oct

24,
15,
15,
15,
15,
15,
15,
08,
08,
08,
08,
08,
08,
18,
18,
18,
18,
18,
18,
24,
24,
24,
24,
24,
24,
15,
15,
15,
15,
15,
15,
16,
16,
16,
16,
16,
16,
29,
29,
29,
29,
29,
29,
17,
17,
17,
17,
17,
17,
16,
16,
16,
16,
16,
16,
10,
10,
10,
10,
10,
10,
30,
30,
30,
30,
30,
30,
30,
30,

2011

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2011

2011

2011

2011

2011

2011

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2011

2011

2011

2011

2011

2011

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2014

2014

2014

2014

2014

2014

2008

2008

2008

2008

2008

2008

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-330(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RISPERIDONE

TABLET;ORAL

RISPERIDONE

AB
1MG
AB
2MG
AB
3MG
AB
4MG
AB
VINTAGE
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
4MG
AB
WOCKHARDT
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
4MG
AB
ZYDUS PHARMS USA INC
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
4MG
TABLET, ORALLY DISINTEGRATING;ORAL

RISPERDAL

AB
JANSSEN PHARMS
0.5MG
AB
+
1MG
AB
2MG
AB
3MG
AB
4MG
RISPERIDONE

AB
ACTAVIS LABS FL INC
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
4MG
AB
DR REDDYS LABS LTD
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
4MG
AB
JUBILANT GENERICS
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
4MG
AB
MYLAN PHARMS INC
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
4MG
AB
PAR PHARM
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
AB
4MG
0.5MG
AB
SANDOZ
AB
1MG
AB
2MG
AB
3MG
AB
4MG
AB
SUN PHARM INDS LTD
0.5MG
AB
0.5MG
AB
1MG
AB
1MG
AB
2MG
AB
2MG
AB
3MG

A079088
A079088
A079088
A079088
A078707
A078707
A078707
A078707
A078707
A078707
A078871
A078871
A078871
A078871
A078871
A078871
A078040
A078040
A078040
A078040
A078040
A078040

003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006

Oct
Oct
Oct
Oct
Dec
Dec
Dec
Dec
Dec
Dec
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

30,
30,
30,
30,
29,
29,
29,
29,
29,
29,
09,
09,
09,
09,
09,
09,
16,
16,
16,
16,
16,
16,

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

N021444
N021444
N021444
N021444
N021444

001
002
003
004
005

Apr
Apr
Apr
Dec
Dec

02,
02,
02,
23,
23,

2003

2003

2003

2004

2004

A076996
A076996
A076996
A076996
A076996
A077328
A077328
A077328
A077328
A077328
A090839
A090839
A090839
A090839
A090839
A091537
A091537
A091537
A091537
A091537
A091537
A077494
A077494
A077494
A077494
A077494
A077494
A078116
A078116
A078116
A078116
A078116
A077542
A078464
A077542
A078464
A077542
A078464
A078464

001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
006
001
002
003
004
005
001
002
003
004
005
006
001
002
003
004
005
001
001
002
002
003
003
004

Apr
Apr
Apr
Apr
Apr
Feb
Oct
Feb
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Feb
Mar
Mar
Mar
Mar
Mar
Apr
Apr
Oct
Apr
Apr
Apr
Dec
Dec
Dec
Dec
Dec
Aug
Apr
Aug
Apr
Aug
Apr
Apr

19,
19,
19,
19,
19,
24,
05,
24,
30,
30,
04,
04,
04,
04,
04,
12,
30,
30,
30,
30,
30,
30,
30,
26,
30,
30,
30,
22,
22,
22,
22,
22,
06,
08,
06,
08,
06,
08,
08,

2011

2011

2011

2011

2011

2009

2009

2009

2009

2009

2011

2011

2011

2011

2011

2013

2011

2011

2011

2011

2011

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2010

2013

2010

2013

2010

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-331(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RISPERIDONE

TABLET, ORALLY DISINTEGRATING;ORAL

RISPERIDONE
AB
3MG

AB
4MG

AB
4MG

AB
TEVA
0.5MG

AB
1MG

AB
2MG

AB
ZYDUS PHARMS USA
0.5MG

AB
2MG

RITONAVIR

CAPSULE;ORAL

NORVIR

+ ABBVIE

SOLUTION;ORAL

NORVIR

+ ABBVIE

TABLET;ORAL

NORVIR

AB
+ ABBVIE

RITONAVIR

AB
ROXANE

RIVAROXABAN

TABLET;ORAL

XARELTO

JANSSEN PHARMS

+

001
005
002
001
002
003
001
003

Aug
Apr
Aug
Mar
Mar
Mar
May
May

06,
08,
06,
12,
12,
12,
01,
01,

2010

2013

2010

2012

2012

2012

2009

2009

100MG

N020945 001 Jun 29, 1999

80MG/ML

N020659 001 Mar 01, 1996

100MG

N022417 001 Feb 10, 2010

100MG

A202573 001 Jan 15, 2015

10MG

15MG

20MG

N022406 001 Jul 01, 2011

N022406 002 Nov 04, 2011

N022406 003 Nov 04, 2011

RIVASTIGMINE

FILM, EXTENDED RELEASE;TRANSDERMAL

EXELON

AB
NOVARTIS

4.6MG/24HR

AB
+

9.5MG/24HR

AB

13.3MG/24HR

RIVASTIGMINE

AB
ALVOGEN PINE BROOK

4.6MG/24HR

AB

9.5MG/24HR

AB

13.3MG/24HR

RIVASTIGMINE TARTRATE

CAPSULE;ORAL

EXELON

AB
+ NOVARTIS

AB

AB

AB

RIVASTIGMINE TARTRATE

AB
ALEMBIC PHARMS LTD

AB

AB

AB

AB
APOTEX INC

AB

AB

AB

AB
DR REDDYS LABS INC

AB

AB

AB

AB
MACLEODS PHARMS LTD

AB

AB

AB

AB
ORCHID HLTHCARE

AB

AB

AB

AB
SUN PHARM INDS

AB

AB

A078474
A078464
A078474
A076908
A076908
A076908
A078516
A078516

N022083 001 Jul 06, 2007

N022083 002 Jul 06, 2007

N022083 005 Aug 31, 2012

A204403 001 Sep 03, 2015

A204403 002 Sep 03, 2015

A204403 003 Aug 31, 2015

EQ
EQ
EQ
EQ

1.5MG BASE

3MG BASE

4.5MG BASE

6MG BASE

N020823
N020823
N020823
N020823

003
004
005
006

Apr
Apr
Apr
Apr

21,
21,
21,
21,

2000

2000

2000

2000

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1.5MG BASE

3MG BASE

4.5MG BASE

6MG BASE

1.5MG BASE

3MG BASE

4.5MG BASE

6MG BASE

1.5MG BASE

3MG BASE

4.5MG BASE

6MG BASE

1.5MG BASE

3MG BASE

4.5MG BASE

6MG BASE

1.5MG BASE

3MG BASE

4.5MG BASE

6MG BASE

1.5MG BASE

3MG BASE

4.5MG BASE

A091689
A091689
A091689
A091689
A091072
A091072
A091072
A091072
A077130
A077130
A077130
A077130
A203148
A203148
A203148
A203148
A090879
A090879
A090879
A090879
A077131
A077131
A077131

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003

Jun
Jun
Jun
Jun
May
May
May
May
Oct
Oct
Oct
Oct
Aug
Aug
Aug
Aug
Jun
Jun
Jun
Jun
Oct
Oct
Oct

12,
12,
12,
12,
16,
16,
16,
16,
31,
31,
31,
31,
22,
22,
22,
22,
10,
10,
10,
10,
22,
22,
22,

2012

2012

2012

2012

2013

2013

2013

2013

2007

2007

2007

2007

2014

2014

2014

2014

2015

2015

2015

2015

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-332(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RIVASTIGMINE TARTRATE

CAPSULE;ORAL

RIVASTIGMINE TARTRATE

AB

AB
WATSON LABS

AB

AB

AB

EQ
EQ
EQ
EQ
EQ

6MG BASE

1.5MG BASE

3MG BASE

4.5MG BASE

6MG BASE

RIZATRIPTAN BENZOATE

TABLET;ORAL

MAXALT

AB
MERCK

EQ 5MG BASE

AB
+

EQ 10MG BASE

RIZATRIPTAN BENZOATE

AB
APOTEX INC

EQ 5MG BASE

AB

EQ 10MG BASE

AB
AUROBINDO PHARMA LTD
EQ 5MG BASE

AB

EQ 10MG BASE

AB
CIPLA LTD

EQ 5MG BASE

AB

EQ 10MG BASE

AB
EMCURE PHARMS LTD

EQ 5MG BASE

AB

EQ 10MG BASE

AB
GLENMARK GENERICS

EQ 5MG BASE

AB

EQ 10MG BASE

AB
INVAGEN PHARMS

EQ 5MG BASE

AB

EQ 10MG BASE

AB
JUBILANT GENERICS

EQ 5MG BASE

AB

EQ 10MG BASE

AB
MACLEODS PHARMS LTD

EQ 5MG BASE

AB

EQ 10MG BASE

AB
MYLAN PHARMS INC

EQ 5MG BASE

AB

EQ 10MG BASE

AB
NATCO PHARMA LTD

EQ 5MG BASE

AB

EQ 10MG BASE

AB
SANDOZ

EQ 5MG BASE

AB

EQ 10MG BASE

AB
SUN PHARMA GLOBAL

EQ 5MG BASE

AB

EQ 10MG BASE

AB
TEVA PHARMS

EQ 5MG BASE

AB

EQ 10MG BASE

TABLET, ORALLY DISINTEGRATING;ORAL

MAXALT-MLT

AB
MERCK

EQ 5MG BASE

AB
+

EQ 10MG BASE

RIZATRIPTAN BENZOATE

AB
APOTEX INC

EQ 5MG BASE

AB

EQ 10MG BASE

AB
AUROBINDO PHARMA LTD
EQ 5MG BASE

AB

EQ 10MG BASE

AB
GLENMARK GENERICS

EQ 5MG BASE

AB

EQ 10MG BASE

AB
JUBILANT GENERICS

EQ 5MG BASE

AB

EQ 10MG BASE

AB
MACLEODS PHARMS LTD

EQ 5MG BASE

AB

EQ 10MG BASE

AB
MYLAN PHARMS INC

EQ 5MG BASE

AB

EQ 10MG BASE

AB
NATCO PHARMA LTD

EQ 5MG BASE

AB

EQ 10MG BASE

AB
SANDOZ

EQ 5MG BASE

AB

EQ 10MG BASE

ROCURONIUM BROMIDE

INJECTABLE;INJECTION

ROCURONIUM BROMIDE

AP
FRESENIUS KABI USA

AP

AP
HOSPIRA

AP

AP
MYLAN INSTITUTIONAL

AP

AP
SAGENT PHARMS

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

A077131
A077129
A077129
A077129
A077129

004
001
002
003
004

Oct
Jan
Jan
Jan
Jan

22,
08,
08,
08,
08,

2007

2008

2008

2008

2008

N020864 001 Jun 29, 1998

N020864 002 Jun 29, 1998

A202244
A202244
A202490
A202490
A077526
A077526
A204090
A204090
A201967
A201967
A204339
A204339
A203252
A203252
A203147
A203147
A201993
A201993
A200482
A200482
A079230
A079230
A202047
A202047
A077263
A077263

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Dec
Dec
Dec
Dec
Mar
Mar
Nov
Nov
Dec
Dec
Jul
Jul
Dec
Dec
Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

31,
31,
31,
31,
26,
26,
26,
26,
31,
31,
01,
01,
31,
31,
11,
11,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,

2012

2012

2012

2012

2013

2013

2013

2013

2012

2012

2013

2013

2014

2014

2014

2014

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

N020865 001 Jun 29, 1998

N020865 002 Jun 29, 1998

A202477
A202477
A203062
A203062
A201914
A201914
A203334
A203334
A203146
A203146
A078173
A078173
A203478
A203478
A078739
A078739

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Jul
Jul
Jul
Jul
Jul
Jul
Oct
Oct
Sep
Sep
Dec
Dec
Jul
Jul
Jul
Jul

01,
01,
01,
01,
01,
01,
16,
16,
19,
19,
31,
31,
01,
01,
01,
01,

2013

2013

2013

2013

2013

2013

2015

2015

2014

2014

2012

2012

2013

2013

2013

2013

A078651
A078651
A078519
A078519
A079199
A079199
A091458

001
002
001
002
001
002
001

Dec
Dec
Nov
Nov
Nov
Nov
Jul

29,
29,
26,
26,
26,
26,
28,

2008

2008

2008

2008

2008

2008

2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-333(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ROCURONIUM BROMIDE

INJECTABLE;INJECTION

ROCURONIUM BROMIDE

AP
AP
+ SANDOZ
AP
+
AP
TAMARANG
AP
AP
TEVA PHARMS
AP

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

A091458
A079195
A079195
A091115
A091115
A078717
A078717

ROFLUMILAST

TABLET;ORAL

DALIRESP

+ ASTRAZENECA PHARMS

500MCG

N022522 001 Feb 28, 2011

ROLAPITANT HYDROCHLORIDE

TABLET;ORAL

VARUBI

+ TESARO INC

EQ 90MG BASE

N206500 001 Sep 01, 2015

ROMIDEPSIN

POWDER;IV (INFUSION)

ISTODAX

+ CELGENE

10MG/VIAL

N022393 001 Nov 05, 2009

EQ
EQ
EQ
EQ
EQ
EQ
EQ

0.25MG BASE

0.5MG BASE

1MG BASE

2MG BASE

3MG BASE

4MG BASE

5MG BASE

N020658
N020658
N020658
N020658
N020658
N020658
N020658

001
002
003
004
006
007
005

Sep
Sep
Sep
Sep
Jan
Jan
Sep

19,
19,
19,
19,
27,
27,
19,

1997

1997

1997

1997

1999

1999

1997

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

0.25MG BASE

0.5MG BASE

1MG BASE

2MG BASE

3MG BASE

4MG BASE

5MG BASE

0.25MG BASE

0.5MG BASE

1MG BASE

2MG BASE

3MG BASE

4MG BASE

5MG BASE

0.25MG BASE

0.5MG BASE

1MG BASE

2MG BASE

3MG BASE

4MG BASE

5MG BASE

0.25MG BASE

0.5MG BASE

1MG BASE

2MG BASE

3MG BASE

4MG BASE

5MG BASE

0.25MG BASE

0.5MG BASE

1MG BASE

2MG BASE

3MG BASE

4MG BASE

5MG BASE

0.25MG BASE

0.5MG BASE

A090429
A090429
A090429
A090429
A090429
A090429
A090429
A079165
A079165
A079165
A079165
A079165
A079165
A079165
A077460
A077460
A077460
A077460
A077460
A077460
A077460
A090135
A090135
A090135
A090135
A090135
A090135
A090135
A078881
A078881
A078881
A078881
A078881
A078881
A078881
A079229
A079229

001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Feb
May
May
May
May
May
May
May
Feb
Feb
Feb
Feb
Feb
Feb
Feb
May
May
May
May
May
May
May
Nov
Nov

24,
24,
24,
24,
24,
24,
24,
07,
07,
07,
07,
07,
07,
07,
05,
05,
05,
05,
05,
05,
19,
25,
25,
25,
25,
25,
25,
25,
05,
05,
05,
05,
05,
05,
19,
28,
28,

2010

2010

2010

2010

2010

2010

2010

2012

2012

2012

2012

2012

2012

2012

2008

2008

2008

2008

2008

2008

2008

2010

2010

2010

2010

2010

2010

2010

2008

2008

2008

2008

2008

2008

2008

2012

2012

ROPINIROLE HYDROCHLORIDE

TABLET;ORAL

REQUIP

AB
+ GLAXOSMITHKLINE LLC

AB

AB

AB

AB

AB

AB

ROPINIROLE HYDROCHLORIDE

AB
ALEMBIC LTD

AB

AB

AB

AB

AB

AB

AB
APOTEX

AB

AB

AB

AB

AB

AB

AB
G AND W LABS INC

AB

AB

AB

AB

AB

AB

AB
GLENMARK GENERICS

AB

AB

AB

AB

AB

AB

AB
MYLAN

AB

AB

AB

AB

AB

AB

AB
ORCHID HLTHCARE

AB

002
001
002
001
002
001
002

Jul
Dec
Dec
Aug
Aug
Nov
Nov

28,
05,
05,
27,
27,
26,
26,

2010

2008

2008

2012

2012

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-334(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ROPINIROLE HYDROCHLORIDE

TABLET;ORAL

ROPINIROLE HYDROCHLORIDE

AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
PRINSTON INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
ROXANE
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
WOCKHARDT
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
ZYDUS PHARMS USA INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
TABLET, EXTENDED RELEASE;ORAL

REQUIP XL

AB
+ GLAXOSMITHKLINE LLC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
ROPINIROLE HYDROCHLORIDE

AB
ACTAVIS ELIZABETH
EQ
AB
EQ
EQ
AB
AB
EQ
AB
EQ
AB
ALEMBIC LTD
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
DR REDDYS LABS LTD
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
MYLAN PHARMS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
SANDOZ INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
WATSON LABS INC
EQ
AB
EQ
AB
EQ

1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE

A079229
A079229
A079229
A079229
A079229
A078110
A078110
A078110
A078110
A078110
A078110
A078110
A077852
A077852
A077852
A077852
A077852
A077852
A077852
A079050
A079050
A079050
A079050
A079050
A079050
A079050
A090411
A090411
A090411
A090411
A090411
A090411
A090411

003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007

Nov
Nov
Nov
Nov
Nov
May
May
May
May
May
May
Jul
May
May
May
May
May
May
May
May
May
May
May
May
May
May
Jun
Jun
Jun
Jun
Jun
Jun
Jun

28,
28,
28,
28,
28,
05,
05,
05,
05,
05,
05,
11,
05,
05,
05,
05,
05,
05,
19,
29,
29,
29,
29,
29,
29,
29,
01,
01,
01,
01,
01,
01,
01,

2012

2012

2012

2012

2012

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2009

2009

2009

2009

2009

2009

2009

2MG BASE
4MG BASE
6MG BASE
8MG BASE
12MG BASE

N022008
N022008
N022008
N022008
N022008

001
003
006
004
005

Jun
Jun
Apr
Jun
Oct

13,
13,
10,
13,
31,

2008

2008

2009

2008

2008

2MG BASE
4MG BASE
6MG BASE
8MG BASE
12MG BASE
2MG BASE
4MG BASE
6MG BASE
8MG BASE
12MG BASE
2MG BASE
4MG BASE
6MG BASE
8MG BASE
12MG BASE
2MG BASE
4MG BASE
6MG BASE
8MG BASE
12MG BASE
2MG BASE
4MG BASE
6MG BASE
8MG BASE
12MG BASE
2MG BASE
4MG BASE
6MG BASE

A090869
A090869
A090869
A090869
A090869
A202786
A202786
A202786
A202786
A202786
A201576
A201576
A201576
A201576
A201576
A200462
A200462
A200462
A200462
A200462
A201047
A201047
A201047
A201047
A201047
A200431
A200431
A200431

001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
003
004
005
006
001
003
004
005
006
001
002
003

May
May
May
May
May
Apr
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

17,
17,
17,
17,
17,
22,
22,
22,
22,
22,
06,
06,
06,
06,
06,
15,
15,
15,
15,
15,
06,
06,
06,
06,
06,
06,
06,
06,

2012

2012

2012

2012

2012

2013

2013

2013

2013

2013

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-335(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ROPINIROLE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ROPINIROLE HYDROCHLORIDE

AB

EQ
AB

EQ
AB
WOCKHARDT LTD

EQ
AB

EQ
AB

EQ
AB

EQ
AB

EQ
MYLAN PHARMS INC

EQ

A200431
A200431
A091395
A091395
A091395
A091395
A091395
A200462

004
005
001
002
003
004
005
002

Jun
Jun
Aug
Aug
Aug
Aug
Aug
Oct

06,
06,
27,
27,
27,
27,
27,
15,

2012

2012

2012

2012

2012

2012

2012

2012

2MG/ML

5MG/ML

7.5MG/ML

10MG/ML

N020533
N020533
N020533
N020533

001
003
004
005

Sep
Sep
Sep
Sep

24,
24,
24,
24,

1996

1996

1996

1996

2MG/ML

5MG/ML

7.5MG/ML

10MG/ML

5MG/ML

10MG/ML

2MG/ML

5MG/ML

7.5MG/ML

10MG/ML

A090194
A090194
A090194
A090194
A078601
A078601
A090318
A090318
A090318
A090318

001
002
003
004
002
003
001
002
003
004

Sep
Sep
Sep
Sep
Jul
Jul
Sep
Sep
Sep
Sep

23,
23,
23,
23,
17,
17,
23,
23,
23,
23,

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

EQ 2MG BASE

EQ 4MG BASE

EQ 8MG BASE

N021071 002 May 25, 1999

N021071 003 May 25, 1999

N021071 004 May 25, 1999

EQ 2MG BASE

EQ 4MG BASE

EQ 8MG BASE

A076747 001 Jan 25, 2013

A076747 002 Jan 25, 2013

A076747 003 Jan 25, 2013

5MG

10MG

20MG

40MG

N021366
N021366
N021366
N021366

002
003
004
005

Aug
Aug
Aug
Aug

12,
12,
12,
12,

2003

2003

2003

2003

ROTIGOTINE

FILM, EXTENDED RELEASE;TRANSDERMAL

NEUPRO

UCB INC
1MG/24HR

+
2MG/24HR

3MG/24HR

4MG/24HR

6MG/24HR

8MG/24HR

N021829
N021829
N021829
N021829
N021829
N021829

004
001
005
002
003
006

Apr
May
Apr
May
May
Apr

02,
09,
02,
09,
09,
02,

2012

2007

2012

2007

2007

2012

RUBIDIUM CHLORIDE RB-82

INJECTABLE;INJECTION

CARDIOGEN-82

BRACCO

N/A

N019414 001 Dec 29, 1989

40MG/ML

N201367 001 Mar 03, 2011

200MG

400MG

N021911 002 Nov 14, 2008

N021911 003 Nov 14, 2008

ROPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

NAROPIN

AP
FRESENIUS KABI USA

AP

AP

AP
+

ROPIVACAINE HYDROCHLORIDE

AP
HOSPIRA

AP

AP

AP

AP
NAVINTA LLC

AP

AP
SAGENT STRIDES

AP

AP

AP

ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDIA

AB
SB PHARMCO

AB

AB
+

ROSIGLITAZONE MALEATE

AB
TEVA

AB

AB

ROSUVASTATIN CALCIUM

TABLET;ORAL

CRESTOR

IPR

RUFINAMIDE

SUSPENSION;ORAL

BANZEL

+ EISAI INC
TABLET;ORAL

BANZEL

EISAI INC
+

8MG BASE

12MG BASE

2MG BASE

4MG BASE

6MG BASE

8MG BASE

12MG BASE

3MG BASE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-336(of 388)

PRESCRIPTION DRUG PRODUCT LIST

RUXOLITINIB PHOSPHATE

TABLET;ORAL

JAKAFI

INCYTE CORP

+

SACROSIDASE

SOLUTION;ORAL

SUCRAID

+ QOL MEDCL

SACUBITRIL; VALSARTAN

TABLET;ORAL

ENTRESTO

NOVARTIS PHARMS CORP

+

SALMETEROL XINAFOATE

POWDER;INHALATION

SEREVENT

+ GLAXOSMITHKLINE

EQ
EQ
EQ
EQ
EQ

5MG BASE

10MG BASE

15MG BASE

20MG BASE

25MG BASE

TABLET;ORAL

KUVAN

+ BIOMARIN PHARM

SAQUINAVIR MESYLATE

CAPSULE;ORAL

INVIRASE

+ HOFFMANN LA ROCHE

TABLET;ORAL

INVIRASE

+ HOFFMANN-LA ROCHE

SAXAGLIPTIN HYDROCHLORIDE

TABLET;ORAL

ONGLYZA

ASTRAZENECA AB

+

SECRETIN SYNTHETIC HUMAN

FOR SOLUTION;INTRAVENOUS

CHIRHOSTIM

+ CHIRHOCLIN

Nov
Nov
Nov
Nov
Nov

16,
16,
16,
16,
16,

2011

2011

2011

2011

2011

N020772 001 Apr 09, 1998

24MG;26MG

49MG;51MG

97MG;103MG

N207620 001 Jul 07, 2015

N207620 002 Jul 07, 2015

N207620 003 Jul 07, 2015

EQ 0.05MG BASE/INH

N020692 001 Sep 19, 1997

N020570 001 Mar 28, 1997

100MG/PACKET

500MG/PACKET

N205065 001 Dec 19, 2013

N205065 002 Oct 27, 2015

100MG

N022181 001 Dec 13, 2007

EQ 200MG BASE

N020628 001 Dec 06, 1995

EQ 500MG BASE

N021785 001 Dec 17, 2004

EQ 2.5MG BASE

EQ 5MG BASE

N022350 001 Jul 31, 2009

N022350 002 Jul 31, 2009

SCOPOLAMINE

FILM, EXTENDED RELEASE;TRANSDERMAL

SCOPOLAMINE
AB
PERRIGO PHARMS CO
1MG/72HR

TRANSDERM SCOP
AB
+ NOVARTIS
1MG/72HR

SECOBARBITAL SODIUM

CAPSULE;ORAL

SECONAL SODIUM

+ MARATHON PHARMS

+

001
002
003
004
005

8,500 IU/ML

SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

INJECTABLE;INJECTION

QUADRAMET

+ LANTHEUS MEDICAL

50mCi/ML

SAPROPTERIN DIHYDROCHLORIDE

POWDER;ORAL

KUVAN

+ BIOMARIN PHARM

N202192
N202192
N202192
N202192
N202192

A078830 001 Jan 30, 2015

N017874 001

50MG

100MG

A086101 001 Oct 03, 1983

A086101 002 Oct 03, 1983

16MCG/VIAL

40MCG/VIAL

N021256 001 Apr 09, 2004

N021256 002 Jun 21, 2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-337(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SELEGILINE

FILM, EXTENDED RELEASE;TRANSDERMAL

EMSAM

+ SOMERSET
6MG/24HR

9MG/24HR

12MG/24HR

SELEGILINE HYDROCHLORIDE

CAPSULE;ORAL

ELDEPRYL

AB
+ SOMERSET
5MG

SELEGILINE HYDROCHLORIDE

AB
APOTEX
5MG

AB
DAVA PHARMS INC
5MG

TABLET;ORAL

SELEGILINE HYDROCHLORIDE

AB
+ APOTEX INC
5MG
AB
MYLAN
5MG
AB
STASON
5MG
TABLET, ORALLY DISINTEGRATING;ORAL

ZELAPAR

+ VALEANT PHARM INTL

1.25MG

SELENIUM SULFIDE

LOTION/SHAMPOO;TOPICAL

SELENIUM SULFIDE

AT
PERRIGO NEW YORK
AT
WOCKHARDT
SELSUN
AT
+ CHATTEM
SELEXIPAG

TABLET;ORAL

UPTRAVI

ACTELION PHARMS LTD

+

SERTACONAZOLE NITRATE

CREAM;TOPICAL

ERTACZO

+ VALEANT LUXEMBOURG

SERTRALINE HYDROCHLORIDE

CONCENTRATE;ORAL

SERTRALINE HYDROCHLORIDE
AA
AUROBINDO PHARMA
ZOLOFT
AA
+ PFIZER
TABLET;ORAL

SERTRALINE HYDROCHLORIDE

AB
ACCORD HLTHCARE

AB

AB

AB
APOTEX INC

AB

AB

AB
AUROBINDO PHARMA

AB

AB

AB
AUSTARPHARMA LLC

AB

AB

AB
INVAGEN PHARMS

AB

AB

AB
LUPIN

AB

AB

AB
MYLAN

N021336 001 Feb 27, 2006

N021336 002 Feb 27, 2006

N021336 003 Feb 27, 2006

N020647 001 May 15, 1996

A075321 001 Dec 04, 1998

A075352 001 Nov 30, 1998

A074871 001 Jun 06, 1997

A074866 001 Nov 26, 1997

A074912 001 Apr 30, 1998

N021479 001 Jun 14, 2006

2.5%

2.5%

A089996 001 Jan 10, 1991

A088228 001 Sep 01, 1983

2.5%

N007936 001

0.2MG

0.4MG

0.6MG

0.8MG

1MG

1.2MG

1.4MG

1.6MG

N207947
N207947
N207947
N207947
N207947
N207947
N207947
N207947

2%

N021385 001 Dec 10, 2003

EQ 20MG BASE/ML

A078861 001 Oct 31, 2008

EQ 20MG BASE/ML

N020990 001 Dec 07, 1999

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A202825
A202825
A202825
A076882
A076882
A076882
A077206
A077206
A077206
A078677
A078677
A078677
A077397
A077397
A077397
A077670
A077670
A077670
A076671

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

001
002
003
004
005
006
007
008

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

Nov
Nov
Nov
Feb
Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Feb

21,
21,
21,
21,
21,
21,
21,
21,

07,
07,
07,
06,
06,
06,
06,
06,
06,
04,
04,
04,
06,
06,
06,
06,
06,
06,
06,

2015

2015

2015

2015

2015

2015

2015

2015

2014

2014

2014

2007

2007

2007

2007

2007

2007

2009

2009

2009

2007

2007

2007

2007

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-338(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SERTRALINE HYDROCHLORIDE

TABLET;ORAL

SERTRALINE HYDROCHLORIDE

AB

AB

AB
MYLAN PHARMS INC

AB

AB

AB
PROSAM LABS

AB

AB

AB
SUN PHARM INDS (IN)

AB

AB

AB
SUN PHARM INDS LTD

AB

AB

AB
TEVA

AB

AB

AB
TORRENT PHARMS

AB

AB

AB
WOCKHARDT

AB

AB

AB
ZYDUS PHARMS USA

AB

AB

ZOLOFT

AB
PFIZER

AB

AB
+

SERTRALINE HYDROCHLORIDE

SUN PHARM INDS LTD

SEVELAMER CARBONATE

FOR SUSPENSION;ORAL

RENVELA

GENZYME

+

TABLET;ORAL

RENVELA

+ GENZYME

SEVELAMER HYDROCHLORIDE

TABLET;ORAL

RENAGEL

GENZYME

+

SEVOFLURANE

LIQUID;INHALATION

SEVOFLURANE

AN
BAXTER HLTHCARE

AN
HALOCARBON PRODS

AN
SHANGHAI HENGRUI

SOJOURN

AN
PIRAMAL CRITICAL

ULTANE

AN
+ ABBVIE

SILDENAFIL CITRATE

FOR SUSPENSION;ORAL

REVATIO

+ PFIZER

SOLUTION;INTRAVENOUS

REVATIO

AP
+ PFIZER

SILDENAFIL CITRATE

AP
AUROBINDO PHARMA LTD

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

A076671
A076671
A078626
A078626
A078626
A078175
A078175
A078175
A078108
A078108
A078108
A077977
A077977
A077977
A076465
A076465
A076465
A077765
A077765
A077765
A078403
A078403
A078403
A077106
A077106
A077106

002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Feb
Feb
Jan
Jan
Jan
Jul
Jul
Jul
Feb
Feb
Feb
Feb
Feb
Feb
Aug
Aug
Aug
Feb
Feb
Feb
Jan
Jan
Jan
Feb
Feb
Feb

06,
06,
31,
31,
31,
21,
21,
21,
06,
06,
06,
06,
06,
06,
11,
11,
11,
06,
06,
06,
08,
08,
08,
06,
06,
06,

2007

2007

2008

2008

2008

2010

2010

2010

2007

2007

2007

2007

2007

2007

2006

2006

2006

2007

2007

2007

2008

2008

2008

2007

2007

2007

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

N019839 005 Mar 06, 1996

N019839 001 Dec 30, 1991

N019839 002 Dec 30, 1991

EQ 150MG BASE

EQ 200MG BASE

A077977 004 Feb 06, 2007

A077977 005 Feb 06, 2007

800MG/PACKET

2.4GM/PACKET

N022318 001 Aug 12, 2009

N022318 002 Feb 18, 2009

800MG

N022127 001 Oct 19, 2007

400MG

800MG

N021179 001 Jul 12, 2000

N021179 002 Jul 12, 2000

100%

100%

100%

A075895 001 Jul 02, 2002

A078650 001 Nov 19, 2007

A203793 001 Nov 03, 2015

100%

A077867 001 May 02, 2007

100%

N020478 001 Jun 07, 1995

EQ 10MG BASE/ML

N203109 001 Aug 30, 2012

EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)

N022473 001 Nov 18, 2009

EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)

A203988 001 Apr 01, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-339(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SILDENAFIL CITRATE

TABLET;ORAL

REVATIO

AB
+ PFIZER
SILDENAFIL CITRATE

AB
ACTAVIS GRP PTC
AB
AMNEAL PHARMS
AB
APOTEX CORP
AB
AUROBINDO PHARMA LTD
AB
DR REDDYS LABS LTD
AB
HETERO LABS LTD V
AB
MACLEODS PHARMS LTD
AB
MYLAN PHARMS INC
AB
TEVA PHARMS
AB
TORRENT PHARMS LTD
AB
WATSON LABS INC
VIAGRA

PFIZER IRELAND
+
SILODOSIN

CAPSULE;ORAL

RAPAFLO

+ ACTAVIS LABS UT INC

EQ 20MG BASE

N021845 001 Jun 03, 2005

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A200149
A202025
A091379
A203963
A202598
A203623
A203814
A201150
A078380
A091479
A202503

20MG
20MG
20MG
20MG
20MG
20MG
20MG
20MG
20MG
20MG
20MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001
001
001
001
001

Feb
Feb
Nov
Nov
Nov
Nov
Dec
Nov
Jan
Nov
Nov

25,
28,
06,
18,
06,
26,
17,
09,
07,
06,
06,

2013

2013

2012

2015

2012

2014

2013

2012

2013

2012

2012

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

N020895 001 Mar 27, 1998

N020895 002 Mar 27, 1998

N020895 003 Mar 27, 1998

4MG
8MG

N022206 001 Oct 08, 2008

N022206 002 Oct 08, 2008

1%

N017381 001

1%

N018578 001 Feb 25, 1982

SILVER SULFADIAZINE

CREAM;TOPICAL

SILVADENE

AB
+ KING PHARMS
SSD

AB
DR REDDYS LA
THERMAZENE

AB
THEPHARMANETWORK LLC
SSD AF

BX
DR REDDYS LA

1%

N018810 001 Dec 23, 1985

1%

N018578 003 Jul 11, 1990

SIMEPREVIR SODIUM

CAPSULE;ORAL

OLYSIO

+ JANSSEN PRODS

EQ 150MG BASE

N205123 001 Nov 22, 2013

SIMVASTATIN

TABLET;ORAL

SIMVASTATIN

AB
ACCORD HLTHCARE
AB
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
AB
BIOCON LIMITED
AB
AB
AB
AB
AB
DR REDDYS LABS INC
AB
AB
AB
AB
AB
HETERO LABS LTD III
AB
AB
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB

5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG

A078155
A078155
A078155
A078155
A078155
A077691
A077691
A077691
A077691
A077691
A078034
A078034
A078034
A078034
A078034
A077752
A077752
A077752
A077752
A077752
A200895
A200895
A200895
A200895
A200895
A076052
A076052
A076052

005
002
003
004
001
001
002
003
004
005
001
002
003
004
005
005
001
002
003
004
001
002
003
004
005
001
002
003

Apr
Feb
Feb
Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jan
Dec
Dec
Dec
Dec
Nov
Nov
Nov
Nov
Nov
Jun
Jun
Jun

05,
26,
26,
26,
26,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
23,
20,
20,
20,
20,
25,
25,
25,
25,
25,
23,
23,
23,

2013

2008

2008

2008

2008

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2008

2006

2006

2006

2006

2014

2014

2014

2014

2014

2006

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-340(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SIMVASTATIN

TABLET;ORAL

SIMVASTATIN
AB
AB
AB
LUPIN
AB
AB
AB
AB
AB
MICRO LABS LTD
AB
AB
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
AB
PROSAM LABS
AB
AB
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
AB
ZOCOR

AB
MERCK
AB
AB
AB
AB
+

40MG

80MG

5MG

10MG

20MG

40MG

80MG

5MG

10MG

20MG

40MG

80MG

5MG

10MG

20MG

40MG

80MG

5MG

10MG

20MG

40MG

80MG

5MG

10MG

20MG

40MG

80MG

5MG

10MG

20MG

40MG

80MG

5MG

10MG

20MG

40MG

80MG

A076052
A076052
A078103
A078103
A078103
A078103
A078103
A090383
A090383
A090383
A090383
A090383
A090868
A090868
A090868
A090868
A090868
A078735
A078735
A078735
A078735
A078735
A076285
A076285
A076285
A076285
A076285
A076685
A076685
A076685
A076685
A076685
A077837
A077837
A077837
A077837
A077837

004
005
005
001
002
003
004
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005

Jun
Dec
Apr
May
May
May
May
Sep
Sep
Sep
Sep
Sep
Jun
Jun
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Aug
Dec
Dec
Dec
Dec
Jun
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

23,
20,
14,
11,
11,
11,
11,
16,
16,
16,
16,
16,
08,
08,
08,
08,
08,
30,
30,
30,
30,
30,
20,
20,
20,
20,
23,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2006

2006

2009

2007

2007

2007

2007

2011

2011

2011

2011

2011

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

5MG

10MG

20MG

40MG

80MG

N019766
N019766
N019766
N019766
N019766

001
002
003
004
005

Dec
Dec
Dec
Dec
Jul

23,
23,
23,
23,
10,

1991

1991

1991

1991

1998

SINCALIDE

INJECTABLE;INJECTION

KINEVAC

+ BRACCO

0.005MG/VIAL

N017697 001

SINECATECHINS

OINTMENT;TOPICAL

VEREGEN

+ MEDIGENE AG

15%

N021902 001 Oct 31, 2006

1MG/ML

N021083 001 Sep 15, 1999

0.5MG

1MG

2MG

N021110 004 Jan 25, 2010

N021110 001 Aug 25, 2000

N021110 002 Aug 22, 2002

1MG

2MG

0.5MG

A201578 001 Oct 27, 2014

A201578 002 Oct 27, 2014

A201676 003 Jan 08, 2014

SIROLIMUS

SOLUTION;ORAL

RAPAMUNE

+ PF PRISM CV
TABLET;ORAL

RAPAMUNE

AB
PF PRISM CV
AB
AB
+
SIROLIMUS

AB
DR REDDYS LABS LTD
AB
AB
ZYDUS PHARMS USA INC

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-341(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SITAGLIPTIN PHOSPHATE

TABLET;ORAL

JANUVIA

MERCK SHARP DOHME
+

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

N021995 001 Oct 16, 2006

N021995 002 Oct 16, 2006
N021995 003 Oct 16, 2006

SODIUM ACETATE ANHYDROUS

INJECTABLE;INJECTION

SODIUM ACETATE IN PLASTIC CONTAINER

+ HOSPIRA
2MEQ/ML

N018893 001 May 04, 1983

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION;IV (INFUSION)

AMMONUL

+ MEDICIS
10%;10% (5GM/50ML;5GM/50ML)

N020645 001 Feb 17, 2005

SODIUM BICARBONATE

INJECTABLE;INJECTION

SODIUM BICARBONATE

+ HOSPIRA
+

A077394 001 Nov 09, 2005

A077394 002 Nov 09, 2005

0.9MEQ/ML
1MEQ/ML

SODIUM CHLORIDE

INJECTABLE;INJECTION

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
FRESENIUS KABI USA
9MG/ML
AP
+ HOSPIRA
9MG/ML
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

AP
B BRAUN
450MG/100ML
AP
BAXTER HLTHCARE
450MG/100ML
AP
HOSPIRA
450MG/100ML
AP
450MG/100ML
SODIUM CHLORIDE 0.9%

AP
EUROHLTH INTL SARL
9MG/ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP
+ B BRAUN
900MG/100ML
AP
+
900MG/100ML
AP
+ BAXTER HLTHCARE
9MG/ML
AP
9MG/ML
AP
+
900MG/100ML
AP
+
900MG/100ML
AP
+ FRESENIUS KABI USA
9MG/ML
AP
FRESENIUS MEDCL
900MG/100ML
AP
HAEMONETICS
900MG/100ML
AP
+ HOSPIRA
9MG/ML
AP
+
9MG/ML
AP
9MG/ML
AP
+
900MG/100ML
AP
+
900MG/100ML
AP
+
900MG/100ML
AP
+ TARO PHARMS IRELAND
9MG/ML
SODIUM CHLORIDE 0.9%

MEDEFIL INC
90MG/10ML (9MG/ML)
SODIUM CHLORIDE 0.9%

EUROHLTH INTL SARL
9MG/ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ LIEBEL-FLARSHEIM
405MG/50ML (9MG/ML)
1012.5MG/125ML (9MG/ML)
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

BAXTER HLTHCARE
3GM/100ML
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5GM/100ML
SODIUM CHLORIDE IN PLASTIC CONTAINER

HOSPIRA
2.5MEQ/ML
SOLUTION;IRRIGATION

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AT
B BRAUN
900MG/100ML
AT
BAXTER HLTHCARE
900MG/100ML
AT
900MG/100ML
AT
HOSPIRA
900MG/100ML
AT
900MG/100ML

A088911 001 Feb 07, 1985

N018800 001 Oct 29, 1982

N019635
N018016
N018090
N019759

001 Mar 09, 1988

001

001

001 Jun 08, 1988

A201850 001 Jan 20, 2012

N017464
N019635
N016677
N020178
N016677
N020178
A088912
A078177
A076316
N018803
N019217
N019465
N016366
N019465
N019480
A077407

001

002
004
002
001

001
001
001
001
001
001
002
001

001
001
001

Mar 09, 1988

Oct 30, 1985

Dec 07, 1992

Dec
Jan
Apr
Oct
Oct
Jul
Jul

07,
10,
12,
27,
29,
13,
15,

1992

1985

2007

2004

1982

1984

1985

Jul 15, 1985

Sep 17, 1985

Aug 11, 2006

N202832 006 Jan 06, 2012

A201833 001 Sep 24, 2013

N021569 001 Jul 27, 2006

N021569 002 Jul 27, 2006

N019022 001 Nov 01, 1983

N019022 002 Nov 01, 1983

N018897 001 Jul 20, 1984

N016733
N017427
N017867
N017514
N018314

001

001

001

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-342(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SODIUM CHLORIDE

SOLUTION FOR SLUSH;IRRIGATION

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER

BAXTER HLTHCARE
900MG/100ML

N019319 002 May 17, 1985

SODIUM FERRIC GLUCONATE COMPLEX

INJECTABLE;INJECTION

FERRLECIT

AB
+ SANOFI AVENTIS US
62.5MG/5ML
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

AB
EUROHLTH INTL SARL
62.5MG/5ML

A078215 001 Mar 31, 2011

SODIUM FLUORIDE F-18

INJECTABLE;INTRAVENOUS

SODIUM FLUORIDE F-18

AP
3D IMAGING DRUG
AP
BIOMEDCL RES FDN
AP
CARDINAL HEALTH 414
AP
ESSENTIAL ISOTOPES
AP
GLOBAL ISOTOPES LLC
AP
HOT SHOTS NM LLC
AP
+ HOUSTON CYCLOTRON
AP
IBA MOLECULAR N AM
AP
MIDWEST MEDCL
AP
MIPS CRF
AP
NCM USA BRONX LLC
AP
PETNET
AP
PRECISION NUCLEAR
AP
SHERTECH LABS LLC
AP
SPECTRON MRC LLC
AP
TRIAD ISOTOPES INC
AP
UCSF RODIOPHARM
AP
UIHC PET IMAGING
AP
UNIV TX MD ANDERSON
AP
UNIV UTAH CYCLOTRON
+ MCPRF
THE FEINSTEIN INST

10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-91.5mCi/ML
20-600mCi/ML

A203777
A204351
A203780
A204541
A204464
A204530
A203544
A203592
A204440
A204517
A204513
A203890
A204542
A204315
A203912
A203968
A204437
A204462
A203247
A204497
A203605
A204328

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Oct
Jan
Jul
Oct
Oct
Jul
Dec
Aug
Nov
Jul
Nov
Sep
Feb
Sep
Apr
Oct
Mar
Nov
Dec
Apr
Jun
Nov

19,
09,
30,
29,
21,
29,
26,
18,
17,
21,
28,
28,
27,
22,
22,
23,
13,
17,
23,
20,
28,
19,

2015

2015

2015

2014

2014

2015

2012

2015

2015

2015

2014

2015

2015

2014

2015

2015

2014

2015

2013

2015

2013

2014

SODIUM IODIDE I-123

CAPSULE;ORAL

SODIUM IODIDE I 123

AA
+ CARDINAL HEALTH 418
AA
+
AA
MALLINKRODT NUCLEAR
AA

100uCi
200uCi
100uCi
200uCi

N018671
N018671
A071909
A071910

001
002
001
001

May
May
Feb
Feb

27,
27,
28,
28,

1982

1982

1989

1989

0.8-100mCi

N016517 001

0.009-0.1mCi

N021305 006 May 19, 2005

250-1000mCi

N021305 007 Dec 05, 2011

3.5-150mCi/VIAL

N016515 001

SODIUM IODIDE I-131

CAPSULE;ORAL

SODIUM IODIDE I 131

+ MALLINKRODT NUCLEAR
SODIUM IODIDE I-131

JUBILANT DRAXIMAGE
SOLUTION;ORAL

HICON

+ JUBILANT DRAXIMAGE
SODIUM IODIDE I 131

+ MALLINKRODT NUCLEAR

N020955 001 Feb 18, 1999

SODIUM LACTATE

INJECTABLE;INJECTION

SODIUM LACTATE IN PLASTIC CONTAINER

+ HOSPIRA
5MEQ/ML

N018947 001 Sep 05, 1984

SODIUM NITRITE

SOLUTION;INTRAVENOUS

SODIUM NITRITE

+ HOPE PHARMS

N203922 001 Feb 14, 2012

300MG/10ML (30MG/ML)

SODIUM NITRITE; SODIUM THIOSULFATE

SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS

NITHIODOTE

+ HOPE PHARMS
300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML
(250MG/ML)

N201444 001 Jan 14, 2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-343(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION

NITROPRESS

+ HOSPIRA

25MG/ML

A071961 001 Aug 01, 1988

SODIUM OXYBATE

SOLUTION;ORAL

XYREM

+ JAZZ PHARMS

500MG/ML

N021196 001 Jul 17, 2002

3GM/TEASPOONFUL

N020573 001 Apr 30, 1996

3GM/TEASPOONFUL

A202819 001 Mar 22, 2013

500MG

N020572 001 May 13, 1996

500MG

A090910 001 Nov 18, 2011

SODIUM PHENYLBUTYRATE

POWDER;ORAL

BUPHENYL

AB
+ HYPERION THERAPS INC
SODIUM PHENYLBUTYRATE

AB
SIGMAPHARM LABS LLC
TABLET;ORAL

BUPHENYL

AB
+ HYPERION THERAPS INC
SODIUM PHENYLBUTYRATE

AB
AMPOLGEN

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET;ORAL

OSMOPREP

+ SALIX PHARMS
0.398GM;1.102GM
N021892 001 Mar 16, 2006

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

INJECTABLE;INJECTION

SODIUM PHOSPHATES IN PLASTIC CONTAINER

+ HOSPIRA
142MG/ML;276MG/ML
N018892 001 May 10, 1983

SODIUM POLYSTYRENE SULFONATE

POWDER;ORAL, RECTAL

KALEXATE

AA
KVK TECH
454GM/BOT
KAYEXALATE

AA
+ CONCORDIA PHARMS INC
453.6GM/BOT
KIONEX

AA
PADDOCK LLC
454GM/BOT
SODIUM POLYSTYRENE SULFONATE

AA
CAROLINA MEDCL
454GM/BOT
AA
CEDAR PHARMS
453.6GM/BOT
AA
EPIC PHARMA LLC
453.6GM/BOT
AA
NUVO PHARM INC
454GM/BOT
KALEXATE

KVK TECH
15GM/BOT
SODIUM POLYSTYRENE SULFONATE

NUVO PHARM INC
15GM/BOT
SUSPENSION;ORAL, RECTAL

KIONEX

AA
PADDOCK LLC
15GM/60ML
SODIUM POLYSTYRENE SULFONATE

AA
PADDOCK LLC
15GM/60ML
AA
ROXANE
15GM/60ML
SPS

AA
+ CAROLINA MEDCL
15GM/60ML

A087859 001 Dec 08, 1982

SODIUM TETRADECYL SULFATE

INJECTABLE;INJECTION

SOTRADECOL

+ MYLAN INSTITUTIONAL
+

20MG/2ML (10MG/ML)
60MG/2ML (30MG/ML)

A040541 001 Nov 12, 2004

A040541 002 Nov 12, 2004

SODIUM THIOSULFATE

SOLUTION;INTRAVENOUS

SODIUM THIOSULFATE

+ HOPE PHARMS

12.5GM/50ML (250MG/ML)

N203923 001 Feb 14, 2012

SOFOSBUVIR

TABLET;ORAL

SOVALDI

+ GILEAD SCIENCES INC

400MG

N204671 001 Dec 06, 2013

A040905 001 Mar 30, 2009

N011287 001

A040029 001 Feb 06, 1998

A089910
A090313
A202333
A204071

001
001
001
001

Jan
Dec
Mar
Nov

19,
21,
19,
28,

1989

2011

2014

2014

A040905 002 Apr 03, 2015

A204071 002 Nov 28, 2014

A040028 001 Sep 17, 2007

A090590 001 May 13, 2011

A089049 001 Nov 17, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-344(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SOLIFENACIN SUCCINATE

TABLET;ORAL

SOLIFENACIN SUCCINATE

AB
TEVA PHARMS USA
AB
VESICARE

AB
ASTELLAS
AB
+

5MG
10MG

A091464 001 Apr 02, 2014

A091464 002 Apr 02, 2014

5MG
10MG

N021518 001 Nov 19, 2004

N021518 002 Nov 19, 2004

SOMATROPIN RECOMBINANT

INJECTABLE;INJECTION

GENOTROPIN

BX
+ PHARMACIA AND UPJOHN
5.8MG/VIAL
GENOTROPIN PRESERVATIVE FREE

BX
PHARMACIA AND UPJOHN
1.5MG/VIAL
HUMATROPE

BX
+ LILLY
5MG/VIAL
BX
6MG/VIAL
NORDITROPIN FLEXPRO

BX
NOVO NORDISK INC
5MG/1.5ML
BX
10MG/1.5ML
OMNITROPE

BX
SANDOZ
1.5MG/VIAL
BX
5MG/1.5ML
BX
5.8MG/VIAL
BX
10MG/1.5ML
SAIZEN

BX
EMD SERONO
5MG/VIAL
SEROSTIM

BX
EMD SERONO
4MG/VIAL
BX
5MG/VIAL
BX
6MG/VIAL
VALTROPIN

BX
LG LIFE
5MG/VIAL
ZOMACTON

BX
+ FERRING
5MG/VIAL
BX
10MG/VIAL
GENOTROPIN

+ PHARMACIA AND UPJOHN
13.8MG/VIAL
GENOTROPIN PRESERVATIVE FREE

PHARMACIA AND UPJOHN 0.2MG/VIAL
0.4MG/VIAL
0.6MG/VIAL
0.8MG/VIAL
1MG/VIAL
1.2MG/VIAL
1.4MG/VIAL
1.6MG/VIAL
1.8MG/VIAL
+
2MG/VIAL
HUMATROPE

+ LILLY
12MG/VIAL
+
24MG/VIAL
NORDITROPIN FLEXPRO

NOVO NORDISK INC
15MG/1.5ML
30MG/3ML
NUTROPIN AQ NUSPIN

+ GENENTECH
5MG/2ML (2.5MG/ML)
+
10MG/2ML (5MG/ML)
+
20MG/2ML (10MG/ML)
NUTROPIN AQ PEN

+ GENENTECH
10MG/2ML (5MG/ML)
+
20MG/2ML (10MG/ML)
SAIZEN

+ EMD SERONO
8.8MG/VIAL
ZORBTIVE

+ EMD SERONO
8.8MG/VIAL

N020280 006 Aug 24, 1995

N020280 004 Aug 24, 1995

N019640 004 Mar 08, 1987

N019640 005 Feb 04, 1999

N021148 008 Mar 01, 2010

N021148 009 Mar 01, 2010

N021426
N021426
N021426
N021426

002
003
001
004

May
Jan
May
Aug

30,
16,
30,
25,

2006

2008

2006

2008

N019764 002 Oct 08, 1996

N020604 003 Jul 25, 1997

N020604 002 Aug 23, 1996

N020604 001 Aug 23, 1996

N021905 001 Apr 19, 2007

N019774 002 Jan 04, 2002

N019774 003 Mar 07, 2012

N020280 007 Oct 23, 1996

N020280
N020280
N020280
N020280
N020280
N020280
N020280
N020280
N020280
N020280

001
002
003
005
008
009
010
011
012
013

Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

1998

1998

1998

1998

1998

1998

1998

1998

1998

1998

N019640 006 Feb 04, 1999

N019640 007 Feb 04, 1999

N021148 010 Mar 01, 2010

N021148 011 Jan 23, 2015

N020522 003 Jan 03, 2008

N020522 005 Jan 03, 2008

N020522 004 Jan 03, 2008

N020522 002 Apr 22, 2002

N020522 006 Jan 03, 2008

N019764 003 Aug 29, 2000

N021597 004 Dec 01, 2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-345(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SONIDEGIB PHOSPHATE

CAPSULE;ORAL

ODOMZO

+ NOVARTIS PHARMS CORP

EQ 200MG BASE

N205266 001 Jul 24, 2015

SORAFENIB TOSYLATE

TABLET;ORAL

NEXAVAR

+ BAYER HLTHCARE

EQ 200MG BASE

N021923 001 Dec 20, 2005

SORBITOL

SOLUTION;IRRIGATION

SORBITOL 3% IN PLASTIC CONTAINER

BAXTER HLTHCARE
3GM/100ML
SORBITOL 3.3% IN PLASTIC CONTAINER

B BRAUN
3.3GM/100ML
SOTALOL HYDROCHLORIDE

SOLUTION;INTRAVENOUS

SOTALOL HYDROCHLORIDE

+ ALTATHERA PHARMS LLC
SOLUTION;ORAL

SOTYLIZE

+ ARBOR PHARMS LLC
TABLET;ORAL

BETAPACE

AB1
COVIS PHARMA SARL
AB1
AB1 +
AB1
SORINE

AB1
UPSHER SMITH
AB1
AB1
AB1
SOTALOL HYDROCHLORIDE

AB1
APOTEX INC
AB1
AB1
AB1
AB1
IMPAX PHARMS
AB1
AB1
AB1
AB1
MYLAN
AB1
AB1
AB1
AB1
AB1
AB1
AB1
AB1
SANDOZ
AB1
AB1
AB1
AB1
TEVA
AB1
AB1
AB1
AB1
VINTAGE PHARMS
AB1
AB1
AB1
BETAPACE AF

AB2
COVIS PHARMA SARL
AB2
AB2 +
SOTALOL HYDROCHLORIDE

AB2
APOTEX
AB2
AB2
AB2
EPIC PHARMA INC
AB2

N017863 001

N016741 001

150MG/10ML (15MG/ML)

N022306 001 Jul 02, 2009

5MG/ML (5MG/ML)

N205108 001 Oct 22, 2014

80MG
120MG
160MG
240MG

N019865
N019865
N019865
N019865

001
005
002
003

Oct
Apr
Oct
Oct

30,
20,
30,
30,

1992

1994

1992

1992

80MG
120MG
160MG
240MG

A075500
A075500
A075500
A075500

001
004
002
003

Apr
Apr
Apr
Apr

27,
27,
27,
27,

2001

2001

2001

2001

80MG
120MG
160MG
240MG
80MG
120MG
160MG
240MG
80MG
80MG
120MG
120MG
160MG
160MG
240MG
240MG
80MG
120MG
160MG
240MG
80MG
120MG
160MG
240MG
80MG
120MG
160MG
240MG

A076140
A076140
A076140
A076140
A075663
A075663
A075663
A075663
A075237
A075725
A075237
A075725
A075237
A075725
A075237
A075725
A075366
A075366
A075366
A075366
A075429
A075429
A075429
A075429
A075563
A075563
A075563
A075563

001
002
003
004
001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004
001
002
003
004
001
002
003
004

Sep
Sep
Sep
Sep
Nov
Nov
Nov
Nov
May
Dec
May
Dec
May
Dec
May
Dec
May
May
May
May
May
May
May
May
Nov
Nov
Nov
Nov

26,
26,
26,
26,
07,
07,
07,
07,
01,
19,
01,
19,
01,
19,
01,
19,
01,
01,
01,
01,
01,
01,
01,
01,
07,
07,
07,
07,

2002

2002

2002

2002

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2003

2003

2003

2003

80MG
120MG
160MG

N021151 001 Feb 22, 2000

N021151 002 Feb 22, 2000

N021151 003 Feb 22, 2000

80MG
120MG
160MG
80MG
120MG

A076214
A076214
A076214
A077070
A077070

001
002
003
001
002

Aug
Aug
Aug
Nov
Nov

27,
27,
27,
04,
04,

2003

2003

2003

2005

2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-346(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SOTALOL HYDROCHLORIDE

TABLET;ORAL

SOTALOL HYDROCHLORIDE

AB2

AB2
MYLAN

AB2

AB2

AB2
TEVA

AB2

AB2

SOYBEAN OIL

INJECTABLE;INJECTION

INTRALIPID 10%

AP
+ FRESENIUS

INTRALIPID 20%

AP
+ FRESENIUS

AP
+

INTRALIPID 30%

AP
+ FRESENIUS

NUTRILIPID 10%

AP
+ B BRAUN

NUTRILIPID 20%

AP
+ B BRAUN

SPINOSAD

SUSPENSION;TOPICAL

NATROBA

+ PARAPRO LLC

SPIRONOLACTONE

TABLET;ORAL

ALDACTONE

AB
GD SEARLE LLC

AB

AB
+

SPIRONOLACTONE

AB
ACTAVIS ELIZABETH

AB

AB

AB
AMNEAL PHARMS

AB

AB

AB
JUBILANT GENERICS

AB

AB

AB
MUTUAL PHARM

AB

AB

AB
MYLAN

AB

AB

AB
ORION CORP ORION

AB

AB

AB
SANDOZ

AB
VINTAGE

AB

AB

STAVUDINE

CAPSULE;ORAL

STAVUDINE

AB
AUROBINDO PHARMA

AB

AB

AB

AB
HETERO LABS LTD III

AB

AB

AB

AB
MATRIX LABS LTD

AB

AB
MYLAN

160MG

80MG

120MG

160MG

80MG

120MG

160MG

A077070
A077616
A077616
A077616
A076883
A076883
A076883

003
001
002
003
001
002
003

10%

N017643 001

20%

20%

N018449 001

N020248 001 Aug 07, 1996

30%

N019942 001 Dec 30, 1993

10%

N019531 001 May 28, 1993

20%

N019531 002 May 28, 1993

0.9%

N022408 001 Jan 18, 2011

25MG

50MG

100MG

N012151 009 Dec 30, 1983

N012151 008 Dec 30, 1982

N012151 010 Dec 30, 1983

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

25MG

50MG

100MG

A040353
A040353
A040353
A091426
A091426
A091426
A203253
A203253
A203253
A089424
A089424
A089424
A040424
A040424
A040424
A202187
A202187
A202187
A086809
A040750
A040750
A040750

003
001
002
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001

001
002
003

Mar
Jul
Jul
Jun
Jun
Jun
Apr
Apr
Apr
Jul
Aug
Aug
Aug
Aug
Aug
Mar
Mar
Mar

15MG

20MG

30MG

40MG

15MG

20MG

30MG

40MG

30MG

40MG

15MG

A077672
A077672
A077672
A077672
A078957
A078957
A078957
A078957
A078775
A078775
A079069

003
004
001
002
001
002
003
004
001
002
001

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jan
Jan
Dec

Nov
Feb
Feb
Feb
Jul
Jul
Jul

04,
07,
07,
07,
26,
26,
26,

15,
29,
29,
08,
08,
08,
23,
23,
23,
23,
11,
11,
20,
20,
20,
06,
06,
06,

2005

2007

2007

2007

2004

2004

2004

2006

1999

1999

2010

2010

2010

2014

2014

2014

1986

1999

1999

2001

2001

2001

2014

2014

2014

Aug 29, 2006

Aug 29, 2006

Aug 29, 2006

29,
29,
29,
29,
29,
29,
29,
29,
05,
05,
29,

2008

2008

2008

2008

2008

2008

2008

2008

2009

2009

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-347(of 388)

PRESCRIPTION DRUG PRODUCT LIST

STAVUDINE

CAPSULE;ORAL

STAVUDINE

AB
AB
AB
ZERIT

AB
BRISTOL MYERS SQUIBB
AB
AB
AB
+
FOR SOLUTION;ORAL

STAVUDINE

AA
AUROBINDO PHARMA
AA
CIPLA LTD
ZERIT

AA
+ BRISTOL MYERS SQUIBB

20MG
30MG
40MG

A079069 002 Dec 29, 2008

A079069 003 Dec 29, 2008

A079069 004 Dec 29, 2008

15MG
20MG
30MG
40MG

N020412
N020412
N020412
N020412

1MG/ML
1MG/ML

A077774 001 Dec 29, 2008

A078030 001 Mar 20, 2009

1MG/ML

N020413 001 Sep 06, 1996

STERILE WATER FOR INJECTION

LIQUID;N/A

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

AP
+ HOSPIRA
100%
STERILE WATER FOR INJECTION

AP
EUROHLTH INTL SARL
100%
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

AP
+ B BRAUN
100%
AP
+ BAXTER HLTHCARE
100%
AP
+
100%
AP
FRESENIUS KABI USA
100%
AP
+ HOSPIRA
100%
AP
+
100%
AP
+
100%
AP
TARO PHARMS IRELAND
100%
STERILE WATER FOR IRRIGATION

LIQUID;IRRIGATION

STERILE WATER

AT
BAXTER HLTHCARE
100%
STERILE WATER IN PLASTIC CONTAINER

AT
B BRAUN
100%
AT
BAXTER HLTHCARE
100%
AT
HOSPIRA
100%
AT
100%

002
003
004
005

Jun
Jun
Jun
Jun

24,
24,
24,
24,

1994

1994

1994

1994

N018802 001 Oct 27, 1982

A206369 001 Sep 02, 2015

N019633
N018632
N018632
A088400
N018233
N018801
N019869
A077393

001
001
002
001
001

001
001
001

Feb
Jun
Apr
Jan

29,
30,
19,
16,

1988

1982

1988

1984

Oct 27, 1982

Dec 26, 1989

Aug 11, 2006

N017428 001

N016734
N017866
N017513
N018313

001

001

001

001

STREPTOMYCIN SULFATE

INJECTABLE;INJECTION

STREPTOMYCIN SULFATE

+ X GEN PHARMS

EQ 1GM BASE/VIAL

A064210 001 Jun 30, 1998

STREPTOZOCIN

INJECTABLE;INJECTION

ZANOSAR

+ TEVA PHARMS USA

1GM/VIAL

N050577 001 May 07, 1982

STRONTIUM CHLORIDE SR-89

INJECTABLE;INJECTION

METASTRON

AP
+ GE HEALTHCARE
STRONTIUM CHLORIDE SR-89

AP
BIO NUCLEONICS

1mCi/ML

N020134 001 Jun 18, 1993

1mCi/ML

A075941 001 Jan 06, 2003

SUCCIMER

CAPSULE;ORAL

CHEMET

+ RECORDATI RARE

100MG

N019998 002 Jan 30, 1991

SUCCINYLCHOLINE CHLORIDE

INJECTABLE;INJECTION

ANECTINE

AP
+ SANDOZ
20MG/ML
QUELICIN

AP
+ HOSPIRA
20MG/ML
QUELICIN PRESERVATIVE FREE

AP
+ HOSPIRA
20MG/ML

N008453 002

N008845 006

N008845 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

SUCRALFATE

SUSPENSION;ORAL

CARAFATE

+ FOREST LABS INC
TABLET;ORAL

CARAFATE

AB
+ FOREST LABS INC
SUCRALFATE

AB
MYLAN PHARMS INC
AB
TEVA
SUCROFERRIC OXYHYDROXIDE

TABLET, CHEWABLE;ORAL

VELPHORO

+ VIFOR FRESENIUS

3-348(of 388)

1GM/10ML

N019183 001 Dec 16, 1993

1GM

N018333 001

1GM
1GM

A074415 001 Jun 08, 1998

A070848 001 Mar 29, 1996

500MG

N205109 001 Nov 27, 2013

SUFENTANIL CITRATE

INJECTABLE;INJECTION

SUFENTA PRESERVATIVE FREE

AP
+ AKORN
SUFENTANIL CITRATE

AP
EUROHLTH INTL SARL
AP
HOSPIRA

EQ 0.05MG BASE/ML

N019050 001 May 04, 1984

EQ 0.05MG BASE/ML
EQ 0.05MG BASE/ML

A074413 001 Dec 15, 1995

A074534 001 Dec 11, 1996

SUGAMMADEX SODIUM

SOLUTION;INTRAVENOUS

BRIDION

ORGANON SUB MERCK
+

200MG/2ML (100MG/ML)
500MG/5ML (100MG/ML)

N022225 002 Dec 15, 2015

N022225 001 Dec 15, 2015

1%

N018737 001 Feb 28, 1989

1%

N018738 001 Aug 30, 1985

10%

N019931 001 Dec 23, 1996

10%
10%
10%

A077015 001 Nov 17, 2006

A078649 001 Mar 23, 2009

A078668 001 May 20, 2009

10%

A080029 001

10%

A080028 001

10%
10%
10%

A040215 001 May 25, 1999

A089560 001 Oct 18, 1988

A040066 001 Dec 28, 1994

500MG

A040091 001 Jul 29, 1994

SULCONAZOLE NITRATE

CREAM;TOPICAL

EXELDERM

+ RANBAXY
SOLUTION;TOPICAL

EXELDERM

+ RANBAXY
SULFACETAMIDE SODIUM

LOTION;TOPICAL

KLARON

AB
+ VALEANT PHARMS NORTH
SULFACETAMIDE SODIUM

AB
FOUGERA PHARMS
AB
PERRIGO CO TENNESSEE
AB
TARO
OINTMENT;OPHTHALMIC

SULFACETAMIDE SODIUM

+ PERRIGO CO TENNESSEE
SOLUTION/DROPS;OPHTHALMIC

BLEPH-10

AT
+ ALLERGAN
SULFACETAMIDE SODIUM

AT
AKORN
AT
ALCON PHARMS LTD
AT
BAUSCH AND LOMB
SULFADIAZINE

TABLET;ORAL

SULFADIAZINE

+ SANDOZ

SULFAMETHOXAZOLE; TRIMETHOPRIM

INJECTABLE;INJECTION

SULFAMETHOXAZOLE AND TRIMETHOPRIM

+ TEVA PHARMS USA
80MG/ML;16MG/ML
SUSPENSION;ORAL

SULFAMETHOXAZOLE AND TRIMETHOPRIM

AB
AUROBINDO PHARMA
200MG/5ML;40MG/5ML
AB
+ HI TECH PHARMA
200MG/5ML;40MG/5ML
AB
VINTAGE
200MG/5ML;40MG/5ML
SULFATRIM PEDIATRIC

AB
STI PHARMA LLC
200MG/5ML;40MG/5ML

A073303 001 Oct 31, 1991

A091348 001 Jun 08, 2010

A074650 001 Dec 29, 1997

A077785 001 Jan 24, 2007

N018615 001 Jan 07, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-349(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SULFAMETHOXAZOLE; TRIMETHOPRIM

TABLET;ORAL

BACTRIM

AB
MUTUAL PHARM
400MG;80MG
BACTRIM DS

AB
+ MUTUAL PHARM
800MG;160MG
SEPTRA

AB
MONARCH PHARMS
400MG;80MG
SEPTRA DS

AB
MONARCH PHARMS
800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM

AB
AMNEAL PHARMS NY
400MG;80MG
AB
800MG;160MG
AB
AUROBINDO PHARMA
400MG;80MG
AB
800MG;160MG
AB
GLENMARK GENERICS
400MG;80MG
AB
800MG;160MG
AB
MUTUAL PHARM
800MG;160MG
AB
VINTAGE
400MG;80MG
AB
800MG;160MG
AB
VISTA PHARMS
400MG;80MG
AB
800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

AB
TEVA
800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH

AB
TEVA PHARMS
400MG;80MG

A070030 001 Jun 02, 1987

SULFANILAMIDE

CREAM;VAGINAL

AVC

+ MEDA PHARMS

15%

N006530 003 Jan 27, 1987

250MG/5ML

A086983 001

500MG

N007073 001

500MG
500MG

A040349 001 Jan 11, 2002

A085828 001

500MG

N007073 002 Apr 06, 1983

500MG

A075339 001 Jan 11, 2002

SULFASALAZINE

SUSPENSION;ORAL

AZULFIDINE

+ PHARMACIA AND UPJOHN
TABLET;ORAL

AZULFIDINE

AB
+ PHARMACIA AND UPJOHN
SULFASALAZINE

AB
VINTAGE PHARMS
AB
WATSON LABS
TABLET, DELAYED RELEASE;ORAL

AZULFIDINE EN-TABS

AB
+ PHARMACIA AND UPJOHN
SULFASALAZINE

AB
VINTAGE PHARMS

N017377 001

N017377 002

N017376 001

N017376 002

A076899
A076899
A090624
A090624
A090828
A090828
A071017
A078060
A078060
A076817
A076817

001
002
001
002
002
001
001
002
001
001
002

Jan
Jan
Feb
Feb
Dec
Dec
Aug
Jan
Jan
Oct
Oct

27,
27,
16,
16,
22,
22,
25,
25,
25,
07,
07,

2005

2005

2010

2010

2010

2010

1986

2007

2007

2005

2005

A070037 001 Jun 02, 1987

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

FOR SUSPENSION;INTRAVENOUS

LUMASON

+ BRACCO
60.7MG/25MG

N203684 001 Oct 15, 2014

SULINDAC

TABLET;ORAL

SULINDAC

AB
EPIC PHARMA
AB
AB
HERITAGE PHARMS INC
AB
AB
MUTUAL PHARM
AB
AB
MYLAN
AB
AB
WATSON LABS
AB
+

150MG
200MG
150MG
200MG
150MG
200MG
150MG
200MG
150MG
200MG

A072710
A072711
A073262
A073262
A072050
A072051
A073039
A073039
A071891
A071795

SUMATRIPTAN

SPRAY;NASAL

IMITREX

+ GLAXOSMITHKLINE
+

5MG/SPRAY
20MG/SPRAY

N020626 001 Aug 26, 1997

N020626 003 Aug 26, 1997

001
001
002
001
001
001
002
001
001
001

Mar
Mar
Sep
Sep
Apr
Apr
Jun
Jun
Apr
Apr

25,
25,
06,
06,
17,
17,
22,
22,
03,
03,

1991

1991

1991

1991

1991

1991

1993

1993

1990

1990

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-350(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS

IMITREX STATDOSE

AB
+ GLAXOSMITHKLINE

AB
+

SUMATRIPTAN SUCCINATE

AB
ANTARES PHARMA INC

AB

AB
DR REDDYS LABS INC

AB
SUN PHARMA GLOBAL

IMITREX

AP
+ GLAXOSMITHKLINE

SUMATRIPTAN SUCCINATE

AP
AUROBINDO PHARMA LTD

AP
BEDFORD

AP
FRESENIUS KABI USA

AP
HIKMA FARMACEUTICA

AP
INJECTALIA

AP
MYLAN LABS LTD

AP
PAR PHARM

AP
PAR STERILE PRODUCTS

AP
SAGENT AGILA

AP
SAGENT STRIDES

AP
TEVA PHARMS USA

AP
WOCKHARDT

ALSUMA

BX
MERIDIAN MEDCL

SUMAVEL DOSEPRO

BX
+ ENDO VENTURES LTD

BX
+

SYSTEM;IONTOPHORESIS

ZECUITY

+ TEVA BRANDED PHARM

TABLET;ORAL

IMITREX

AB
GLAXOSMITHKLINE

AB

AB
+

SUMATRIPTAN SUCCINATE

AB
APOTEX INC

AB

AB

AB
AUROBINDO PHARMA

AB

AB

AB
DR REDDYS LABS INC

AB

AB

AB
HIKMA PHARMS

AB

AB

AB
MYLAN

AB

AB

AB
ORCHID HLTHCARE

AB

AB

AB
SUN PHARM INDS

AB

AB

AB
SUN PHARM INDS LTD

AB

AB

AB
WATSON LABS

AB

AB

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N020080 002 Feb 01, 2006

N020080 003 Dec 23, 1996

EQ
EQ
EQ
EQ

A078319
A078319
A090495
A090358

4MG
6MG
6MG
6MG

BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML

(EQ
(EQ
(EQ
(EQ

8MG BASE/ML)

12MG BASE/ML)

12MG BASE/ML)

12MG BASE/ML)

001
002
001
001

Dec
Dec
Jan
Jun

10,
10,
29,
21,

2015

2015

2014

2011

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N020080 001 Dec 28, 1992

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A202758
A079123
A079242
A200183
A090310
A203322
A077332
A077871
A090641
A090314
A077907
A078593

6MG
6MG
6MG
6MG
6MG
6MG
6MG
6MG
6MG
6MG
6MG
6MG

BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML

(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ

12MG
12MG
12MG
12MG
12MG
12MG
12MG
12MG
12MG
12MG
12MG
12MG

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

BASE/ML)

001
001
001
001
001
001
001
001
001
001
001
001

Apr
Feb
Mar
Sep
Aug
Apr
Oct
Jul
Jul
Jun
Feb
Feb

23,
06,
02,
16,
11,
14,
09,
09,
28,
10,
06,
06,

2013

2009

2009

2013

2010

2014

2009

2009

2010

2010

2009

2009

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N022377 001 Jun 29, 2010

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N022239 002 Nov 26, 2013

N022239 001 Jul 15, 2009

EQ 6.5MG BASE/4HR

N202278 001 Jan 17, 2013

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

N020132 002 Jun 01, 1995

N020132 003 Jun 01, 1995

N020132 001 Jun 01, 1995

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A200263
A200263
A200263
A078327
A078327
A078327
A076847
A076847
A076847
A078298
A078298
A078298
A077744
A077744
A077744
A078284
A078284
A078284
A078295
A078295
A078295
A076554
A076554
A076572
A076933
A076933
A076933

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

25MG BASE

50MG BASE

100MG BASE

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
001
001
002
003

Jun
Jun
Jun
Aug
Aug
Aug
Aug
Aug
Aug
May
May
May
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Feb
Aug
Aug
Aug

19,
19,
19,
10,
10,
10,
10,
10,
10,
21,
21,
21,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
09,
10,
10,
10,

2012

2012

2012

2009

2009

2009

2009

2009

2009

2013

2013

2013

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-351(of 388)

PRESCRIPTION DRUG PRODUCT LIST

SUNITINIB MALATE

CAPSULE;ORAL

SUNITINIB MALATE
AB
MYLAN PHARMS INC
AB
AB
AB
SUTENT
AB
CPPI CV
AB
AB
AB
+
SUVOREXANT

TABLET;ORAL

BELSOMRA

MERCK SHARP DOHME

EQ
EQ
EQ
EQ

12.5MG BASE

25MG BASE

37.5MG BASE

50MG BASE

A201275
A201275
A201275
A201275

001
002
003
004

Jan
Jan
Jan
Jan

30,
30,
30,
30,

2014

2014

2014

2014

EQ
EQ
EQ
EQ

12.5MG BASE

25MG BASE

37.5MG BASE

50MG BASE

N021938
N021938
N021938
N021938

001
002
004
003

Jan
Jan
Mar
Jan

26,
26,
31,
26,

2006

2006

2009

2006

N204569
N204569
N204569
N204569

001
002
003
004

Aug
Aug
Aug
Aug

13,
13,
13,
13,

2014

2014

2014

2014

5MG

10MG

15MG

20MG

TACROLIMUS

CAPSULE;ORAL

PROGRAF

AB
ASTELLAS

EQ 0.5MG BASE

AB

EQ 1MG BASE

AB
+

EQ 5MG BASE

TACROLIMUS

AB
ACCORD HLTHCARE

EQ 0.5MG BASE

AB

EQ 1MG BASE

AB

EQ 5MG BASE

AB
DR REDDYS LABS LTD

EQ 0.5MG BASE

AB

EQ 1MG BASE

AB

EQ 5MG BASE

AB
MYLAN

EQ 0.5MG BASE

AB

EQ 1MG BASE

AB

EQ 5MG BASE

AB
PANACEA BIOTEC LTD

EQ 0.5MG BASE

AB

EQ 1MG BASE

AB

EQ 5MG BASE

AB
SANDOZ

EQ 0.5MG BASE

AB

EQ 1MG BASE

AB

EQ 5MG BASE

AB
STRIDES PHARMA

EQ 0.5MG BASE

AB

EQ 1MG BASE

AB

EQ 5MG BASE

CAPSULE, EXTENDED RELEASE;ORAL

ASTAGRAF XL

ASTELLAS

EQ 0.5MG BASE

EQ 1MG BASE

+

EQ 5MG BASE

INJECTABLE;INJECTION

PROGRAF

+ ASTELLAS

EQ 5MG BASE/ML

OINTMENT;TOPICAL

PROTOPIC
AB
+ ASTELLAS
0.03%

AB
+
0.1%

TACROLIMUS
AB
FOUGERA PHARMS INC
0.03%

AB
0.1%

TABLET, EXTENDED RELEASE;ORAL

ENVARSUS XR

VELOXIS PHARMS INC

EQ 0.75MG BASE

EQ 1MG BASE

+

EQ 4MG BASE

TADALAFIL

TABLET;ORAL

ADCIRCA

+ ELI LILLY CO

CIALIS

LILLY

N050708 003 Aug 24, 1998

N050708 001 Apr 08, 1994

N050708 002 Apr 08, 1994

A091195
A091195
A091195
A090509
A090509
A090509
A090596
A090596
A090596
A090802
A090802
A090802
A065461
A065461
A065461
A090687
A090687
A090687

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Aug
Aug
Aug
May
May
May
Sep
Sep
Sep
Sep
Sep
Sep
Aug
Aug
Aug
Jul
Jul
Jul

31,
31,
31,
12,
12,
12,
17,
17,
17,
28,
28,
28,
10,
10,
10,
22,
22,
22,

2011

2011

2011

2010

2010

2010

2010

2010

2010

2012

2012

2012

2009

2009

2009

2014

2014

2014

N204096 001 Jul 19, 2013

N204096 002 Jul 19, 2013

N204096 003 Jul 19, 2013

N050709 001 Apr 08, 1994

N050777 001 Dec 08, 2000

N050777 002 Dec 08, 2000

A200744 001 Sep 09, 2014

A200744 002 Sep 09, 2014

N206406 001 Jul 10, 2015

N206406 002 Jul 10, 2015

N206406 003 Jul 10, 2015

20MG

N022332 001 May 22, 2009

2.5MG

5MG

N021368 004 Jan 07, 2008

N021368 001 Nov 21, 2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-352(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TADALAFIL

TABLET;ORAL

CIALIS

+

TAFLUPROST

SOLUTION/DROPS;OPHTHALMIC

ZIOPTAN

+ OAK PHARMS INC

10MG

20MG

N021368 002 Nov 21, 2003

N021368 003 Nov 21, 2003

0.0015%

N202514 001 Feb 10, 2012

TALC

AEROSOL, METERED;INTRAPLEURAL

SCLEROSOL

+ BRYAN

400MG/SPRAY

POWDER;INTRAPLEURAL

TALC

+ BRYAN

5GM/BOT

TALIGLUCERASE ALFA

POWDER;IV (INFUSION)

ELELYSO

+ PFIZER

TAMOXIFEN CITRATE

SOLUTION;ORAL

SOLTAMOX

DARA BIOSCIENCES

TABLET;ORAL

TAMOXIFEN CITRATE
AB
ACTAVIS LABS FL INC
AB
AB
AB
AB
APOTEX
AB
AB
MYLAN
AB
AB
TEVA
AB
+ TEVA PHARMS
TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL

FLOMAX

AB
+ BOEHRINGER INGELHEIM

TAMSULOSIN HYDROCHLORIDE

AB
ANCHEN PHARMS

AB
AUROBINDO PHARMA LTD

AB
IMPAX LABS

AB
MYLAN

AB
SANDOZ

AB
SUN PHARM INDS LTD

AB
SYNTHON PHARMS

AB
TEVA PHARMS

AB
WOCKHARDT

AB
ZYDUS PHARMS USA INC

TAPENTADOL HYDROCHLORIDE

SOLUTION;ORAL

NUCYNTA

+ DEPOMED INC

TABLET;ORAL

NUCYNTA

DEPOMED INC

N020587 001 Dec 24, 1997

N021388 001 Dec 15, 2003

200 UNITS/VIAL

N022458 001 May 01, 2012

EQ 10MG BASE/5ML

N021807 001 Oct 29, 2005

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A070929
A076179
A070929
A076179
A090878
A090878
A074732
A074732
A075797
A074858

10MG
10MG
20MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

001
001
002
002
001
002
002
001
001
001

Feb
Feb
Feb
Feb
Sep
Sep
Feb
Feb
Feb
Feb

20,
20,
20,
20,
23,
23,
20,
20,
20,
20,

2003

2003

2003

2003

2011

2011

2003

2003

2003

2003

0.4MG

N020579 001 Apr 15, 1997

0.4MG

0.4MG

0.4MG

0.4MG

0.4MG

0.4MG

0.4MG

0.4MG

0.4MG

0.4MG

A202010
A202433
A090377
A090408
A078015
A090931
A078801
A077630
A078938
A078225

EQ 20MG BASE/ML

N203794 001 Oct 15, 2012

EQ 50MG BASE

EQ 75MG BASE

+

EQ 100MG BASE

TABLET, EXTENDED RELEASE;ORAL

NUCYNTA ER

DEPOMED INC

EQ 50MG BASE

EQ 100MG BASE

EQ 150MG BASE

EQ 200MG BASE

+

EQ 250MG BASE

001
001
001
001
001
001
001
001
001
001

Jan
Apr
Mar
Apr
Apr
Jul
Apr
Apr
Apr
Apr

04,
30,
02,
27,
27,
15,
27,
27,
27,
27,

2013

2013

2010

2010

2010

2010

2010

2010

2010

2010

N022304 001 Nov 20, 2008

N022304 002 Nov 20, 2008

N022304 003 Nov 20, 2008

N200533
N200533
N200533
N200533
N200533

001
002
003
004
005

Aug
Aug
Aug
Aug
Aug

25,
25,
25,
25,
25,

2011

2011

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

3-353(of 388)

TASIMELTEON
CAPSULE;ORAL
HETLIOZ
+ VANDA PHARMS INC

20MG

N205677 001 Jan 31, 2014

TAVABOROLE
SOLUTION;TOPICAL
KERYDIN
+ ANACOR PHARMS INC

5%

N204427 001 Jul 07, 2014

0.1%

N202428 001 May 11, 2012

0.1%

N021184 003 Sep 30, 2002

0.05%
0.1%

N021184 001 Sep 29, 2000

N021184 002 Sep 29, 2000

0.05%
0.1%

N020600 001 Jun 13, 1997

N020600 002 Jun 13, 1997

TAZAROTENE
AEROSOL, FOAM;TOPICAL
FABIOR
+ STIEFEL LABS INC
CREAM;TOPICAL
AVAGE
+ ALLERGAN
TAZORAC
+ ALLERGAN
+
GEL;TOPICAL
TAZORAC
+ ALLERGAN
+

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE;INJECTION

PULMOLITE

BS
JUBILANT DRAXIMAGE
N/A
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT

BS
DRAXIMAGE
N/A

N017776 001

N017881 001 Dec 30, 1987

TECHNETIUM TC-99M BICISATE KIT

INJECTABLE;INJECTION

NEUROLITE

LANTHEUS MEDCL
N/A

N020256 001 Nov 23, 1994

TECHNETIUM TC-99M DISOFENIN KIT

INJECTABLE;INJECTION

HEPATOLITE

PHARMALUCENCE
N/A

N018467 001 Mar 16, 1982

TECHNETIUM TC-99M EXAMETAZIME KIT

INJECTABLE;INJECTION

CERETEC

+ GE HEALTHCARE
N/A

N019829 001 Dec 30, 1988

TECHNETIUM TC-99M MEBROFENIN KIT

INJECTABLE;INJECTION

CHOLETEC

AP
+ BRACCO
N/A
TECHNETIUM TC-99M MEBROFENIN

AP
PHARMALUCENCE
N/A

A078242 001 Jan 29, 2008

TECHNETIUM TC-99M MEDRONATE

INJECTABLE;INJECTION

DRAXIMAGE MDP-25

+ JUBILANT DRAXIMAGE

N018035 002 Feb 27, 2004

N/A

TECHNETIUM TC-99M MEDRONATE KIT

INJECTABLE;INJECTION

CIS-MDP

AP
PHARMALUCENCE
N/A
MDP-BRACCO

AP
BRACCO
N/A

N018963 001 Jan 21, 1987

N018124 001

N018107 001

TECHNETIUM TC-99M MERTIATIDE KIT

INJECTABLE;INJECTION

TECHNESCAN MAG3

+ MALLINKRODT NUCLEAR
N/A

N019882 001 Jun 15, 1990

TECHNETIUM TC-99M OXIDRONATE KIT

INJECTABLE;INJECTION

TECHNESCAN

+ MALLINKRODT NUCLEAR
N/A

N018321 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-354(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE;INJECTION

AN-DTPA
AP
JUBILANT DRAXIMAGE
N/A
DTPA
AP
DRAXIMAGE
N/A

N017714 001
N018511 001 Dec 29, 1989

TECHNETIUM TC-99M PYROPHOSPHATE KIT

INJECTABLE;INJECTION

CIS-PYRO

AP
PHARMALUCENCE
N/A
TECHNESCAN PYP KIT

AP
MALLINKRODT NUCLEAR
N/A

N017538 001

TECHNETIUM TC-99M RED BLOOD CELL KIT

INJECTABLE;INJECTION

ULTRATAG

MALLINKRODT NUCLEAR
N/A

N019981 001 Jun 10, 1991

TECHNETIUM TC-99M SESTAMIBI KIT

INJECTABLE;INJECTION

CARDIOLITE

AP
+ LANTHEUS MEDCL
N/A
TECHNETIUM TC 99M SESTAMIBI

AP
CARDINAL HEALTH 414
N/A
AP
DRAXIMAGE
N/A
AP
PHARMALUCENCE
10-30mCi
TECHNETIUM TC-99M SESTAMIBI

AP
MALLINKRODT NUCLEAR
N/A

N019039 001 Jun 30, 1987

N019785 001 Dec 21, 1990

A078809 001 Apr 28, 2009

A078806 001 Apr 29, 2009

A079157 001 Jul 10, 2009

A078098 001 Sep 22, 2008

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION;INTRAVENOUS

TECHNELITE

+ LANTHEUS MEDCL
1-20 CI/GENERATOR
ULTRA-TECHNEKOW FM

+ MALLINCKRODT
1-19 CI/GENERATOR
SOLUTION;INTRAVENOUS, ORAL

TECHNETIUM TC 99M GENERATOR

+ GE HEALTHCARE
68-2703mCi/GENERATOR

N017693 002 Dec 13, 2013

TECHNETIUM TC-99M SUCCIMER KIT

INJECTABLE;INJECTION

MPI DMSA KIDNEY REAGENT

GE HEALTHCARE
N/A

N017944 001 May 18, 1982

TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION;INJECTION, ORAL

AN-SULFUR COLLOID

+ PHARMALUCENCE
N/A

N017858 001

TECHNETIUM TC-99M TETROFOSMIN KIT

INJECTABLE;INJECTION

MYOVIEW

+ GE HEALTHCARE
N/A
MYOVIEW 30ML

+ GE HEALTHCARE
N/A
TECHNETIUM TC-99M TILMANOCEPT

INJECTABLE;INJECTION

LYMPHOSEEK KIT

+ NAVIDEA BIOPHARMS
TEDIZOLID PHOSPHATE

POWDER;IV (INFUSION)

SIVEXTRO

+ CUBIST PHARMS LLC
TABLET;ORAL

SIVEXTRO

+ CUBIST PHARMS LLC
TEDUGLUTIDE RECOMBINANT

POWDER;SUBCUTANEOUS

GATTEX KIT

+ NPS PHARMS INC

N017771 002 Feb 12, 2014

N017243 003 Feb 18, 2014

N020372 001 Feb 09, 1996

N020372 002 Jul 07, 2005

N/A

N202207 001 Mar 13, 2013

200MG/VIAL

N205436 001 Jun 20, 2014

200MG

N205435 001 Jun 20, 2014

5MG/VIAL

N203441 001 Dec 21, 2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-355(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TELAVANCIN HYDROCHLORIDE

POWDER;IV (INFUSION)

VIBATIV

THERAVANCE BIOPHARMA
+

EQ 250MG BASE/VIAL
EQ 750MG BASE/VIAL

N022110 001 Sep 11, 2009

N022110 002 Sep 11, 2009

TELBIVUDINE

TABLET;ORAL

TYZEKA

+ NOVARTIS

600MG

N022011 001 Oct 25, 2006

TELITHROMYCIN

TABLET;ORAL

KETEK

SANOFI AVENTIS US
+

300MG
400MG

N021144 002 Feb 09, 2005

N021144 001 Apr 01, 2004

20MG
40MG
80MG

N020850 003 Apr 04, 2000

N020850 001 Nov 10, 1998

N020850 002 Nov 10, 1998

20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG

A202130
A202130
A202130
A204415
A204415
A204415
A206511
A206511
A206511
A090032
A090032
A090032
A205150
A205150
A205150
A202397
A202397
A202397
A203867
A203867
A203867
A203171
A203171
A203171
A078710
A078710
A078710
A203325
A203325
A203325

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

7.5MG
15MG
22.5MG
30MG

N018163
N018163
N018163
N018163

003 Oct 25, 1991

001

004 Nov 02, 2004

002

15MG
30MG
7.5MG
22.5MG
7.5MG
15MG
22.5MG
30MG
7.5MG
15MG
22.5MG

A071638
A071620
A078581
A071175
A070920
A070920
A070920
A070920
A071457
A071456
A071457

001
001
001
002
002
004
003
001
002
001
003

TELMISARTAN

TABLET;ORAL

MICARDIS

AB
BOEHRINGER INGELHEIM
AB
AB
+
TELMISARTAN

AB
ALEMBIC PHARMS LTD
AB
AB
AB
AMNEAL PHARMS
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
INVENTIA HLTHCARE
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
SANDOZ INC
AB
AB
AB
TORRENT PHARMS LTD
AB
AB
AB
WATSON LABS
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
TEMAZEPAM

CAPSULE;ORAL

RESTORIL

AB
MALLINCKRODT INC
AB
AB
AB
+
TEMAZEPAM

AB
ACTAVIS ELIZABETH
AB
AB
MUTUAL PHARM
AB
AB
MYLAN
AB
AB
AB
AB
NOVEL LABS INC
AB
AB

Jul
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Oct
Oct
Oct
Jul
Jul
Jul
Nov
Nov
Nov
Jul
Jul
Jul
Jan
Jan
Jan
Aug
Aug
Aug

Aug
Aug
Sep
Sep
May
Jul
Jun
Jul
Jun
Apr
Jun

07,
07,
07,
08,
08,
08,
03,
03,
03,
07,
07,
07,
30,
30,
30,
07,
07,
07,
03,
03,
03,
07,
07,
07,
08,
08,
08,
26,
26,
26,

07,
07,
08,
14,
21,
07,
12,
10,
22,
21,
22,

2014

2014

2014

2015

2015

2015

2015

2015

2015

2014

2014

2014

2015

2015

2015

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

2014

1987

1987

2009

2009

2010

1986

2009

1986

2012

1987

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-356(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TEMAZEPAM

CAPSULE;ORAL

TEMAZEPAM
AB
AB
SANDOZ
AB
AB
VINTAGE PHARMS
AB
AB
AB
TEMOZOLOMIDE

CAPSULE;ORAL

TEMODAR

AB
MERCK SHARP DOHME

AB

AB

AB

AB

AB
+

TEMOZOLOMIDE

AB
AMNEAL PHARMS

AB

AB

AB

AB

AB

AB
BARR

AB

AB

AB

AB

AB

AB
SUN PHARMA GLOBAL

AB

AB

AB

AB

AB

POWDER;INTRAVENOUS

TEMODAR

+ MERCK SHARP DOHME

30MG

15MG

30MG

7.5MG

15MG

22.5MG

30MG

A071457
A071427
A071428
A201781
A201781
A201781
A201781

001
001
001
001
002
003
004

Apr
Jan
Jan
Jun
Jun
Jun
Jun

21,
12,
12,
04,
04,
04,
04,

1987

1988

1988

2015

2015

2015

2015

5MG

20MG

100MG

140MG

180MG

250MG

N021029
N021029
N021029
N021029
N021029
N021029

001
002
003
005
006
004

Aug
Aug
Aug
Oct
Oct
Aug

11,
11,
11,
19,
19,
11,

1999

1999

1999

2006

2006

1999

5MG

20MG

100MG

140MG

180MG

250MG

5MG

20MG

100MG

140MG

180MG

250MG

5MG

20MG

100MG

140MG

180MG

250MG

A203691
A203691
A203691
A203691
A203691
A203691
A078879
A078879
A078879
A078879
A078879
A078879
A201742
A201742
A201742
A201742
A201742
A201742

001
002
003
004
005
006
001
002
003
005
006
004
001
002
003
004
005
006

May
May
May
May
May
May
Mar
Mar
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb

08,
08,
08,
08,
08,
08,
01,
01,
01,
01,
01,
01,
12,
12,
12,
12,
12,
12,

2015

2015

2015

2015

2015

2015

2010

2010

2010

2010

2010

2010

2014

2014

2014

2014

2014

2014

100MG/VIAL

N022277 001 Feb 27, 2009

TEMSIROLIMUS

SOLUTION;INTRAVENOUS

TORISEL

+ PF PRISM CV

25MG/ML (25MG/ML)

N022088 001 May 30, 2007

TENIPOSIDE

INJECTABLE;INJECTION

VUMON

+ HQ SPECLT PHARMA

10MG/ML

N020119 001 Jul 14, 1992

TENOFOVIR DISOPROXIL FUMARATE

POWDER;ORAL

VIREAD

+ GILEAD SCIENCES INC

40MG/SCOOPFUL

TABLET;ORAL

TENOFOVIR DISOPROXIL FUMARATE

AB
TEVA PHARMS USA
300MG

VIREAD
AB
+ GILEAD SCIENCES INC
300MG

150MG

200MG

250MG

TERAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

TERAZOSIN HYDROCHLORIDE

AB
APOTEX

AB

AB

AB

AB
IVAX SUB TEVA PHARMS

AB

EQ
EQ
EQ
EQ
EQ
EQ

1MG BASE

2MG BASE

5MG BASE

10MG BASE

1MG BASE

2MG BASE

N022577 001 Jan 18, 2012

A091612 001 Mar 18, 2015

N021356
N021356
N021356
N021356

001
002
003
004

Oct
Jan
Jan
Jan

26,
18,
18,
18,

2001

2012

2012

2012

A075498
A075498
A075498
A075498
A075614
A075614

001
002
003
004
002
001

Apr
Apr
Apr
Apr
Jan
Jan

12,
12,
12,
12,
30,
30,

2001

2001

2001

2001

2001

2001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-357(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TERAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

TERAZOSIN HYDROCHLORIDE

AB
AB
AB
JUBILANT CADISTA
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
SANDOZ
AB
+
AB
AB
TERBINAFINE HYDROCHLORIDE

GRANULE;ORAL

LAMISIL

NOVARTIS
+
TABLET;ORAL

LAMISIL

AB
+ NOVARTIS
TERBINAFINE HYDROCHLORIDE

AB
APOTEX
AB
AUROBINDO PHARMA
AB
BRECKENRIDGE PHARM
AB
CIPLA LTD
AB
DR REDDYS LABS INC
AB
GLENMARK GENERICS
AB
HARRIS PHARM
AB
INVAGEN PHARMS
AB
MYLAN
AB
ORCHID HLTHCARE
AB
TEVA
TERBUTALINE SULFATE

INJECTABLE;INJECTION

TERBUTALINE SULFATE

AP
AKORN
AP
+ BEDFORD
AP
FRESENIUS KABI USA
AP
HIKMA FARMACEUTICA
AP
UNITED BIOMEDCL
TABLET;ORAL

TERBUTALINE SULFATE

AB
IMPAX LABS
AB
+
AB
LANNETT
AB
TERCONAZOLE

CREAM;VAGINAL

TERAZOL 3

AB
+ JANSSEN PHARMS
TERAZOL 7

AB
+ JANSSEN PHARMS
TERCONAZOLE

AB
FOUGERA PHARMS
AB
TARO
AB
BX
+ NYCOMED US
SUPPOSITORY;VAGINAL

TERAZOL 3

AB
+ JANSSEN PHARMS
TERCONAZOLE

AB
PERRIGO NEW YORK
AB
TARO

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
1MG BASE
2MG BASE
5MG BASE
10MG BASE
1MG BASE
2MG BASE
5MG BASE
10MG BASE
1MG BASE
2MG BASE
5MG BASE
10MG BASE

A075614
A075614
A075317
A075317
A075317
A075317
A075140
A075140
A075140
A075140
A074823
A074823
A074823
A074823

003
004
001
002
003
004
002
003
001
004
001
002
003
004

Jan
Jan
Dec
Dec
Dec
Dec
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar

30,
30,
20,
20,
20,
20,
11,
11,
11,
11,
30,
30,
30,
30,

2001

2001

2004

2004

2004

2004

2000

2000

2000

2000

1998

1998

1998

1998

EQ 125MG BASE/PACKET
EQ 187.5MG BASE/PACKET

N022071 001 Sep 28, 2007

N022071 002 Sep 28, 2007

EQ 250MG BASE

N020539 001 May 10, 1996

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A078199
A078297
A077714
A077137
A076390
A078157
A077919
A077533
A077195
A078163
A076377

001
001
001
001
001
001
001
001
001
001
001

Jul
Jul
Jun
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

02,
02,
04,
02,
02,
02,
02,
02,
02,
02,
02,

2007

2007

2010

2007

2007

2007

2007

2007

2007

2007

2007

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML

A078151
A076770
A076887
A078630
A200122

001
001
001
001
001

Jan
Apr
May
May
Nov

07,
23,
26,
20,
08,

2008

2004

2004

2009

2013

2.5MG
5MG
2.5MG
5MG

A075877
A075877
A077152
A077152

001
002
001
002

Jun
Jun
Mar
Mar

26,
26,
25,
25,

2001

2001

2005

2005

0.8%

N019964 001 Feb 21, 1991

0.4%

N019579 001 Dec 31, 1987

0.4%
0.4%
0.8%
0.8%

A076712
A076043
A075953
N021735

80MG

N019641 001 May 24, 1988

80MG
80MG

A077149 001 Mar 17, 2006

A077553 001 Mar 09, 2007

250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001

Feb
Jan
Apr
Oct

18,
19,
06,
01,

2005

2005

2004

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-358(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TERIFLUNOMIDE

TABLET;ORAL

AUBAGIO

SANOFI AVENTIS US
+

7MG
14MG

N202992 001 Sep 12, 2012

N202992 002 Sep 12, 2012

TERIPARATIDE RECOMBINANT HUMAN

INJECTABLE;SUBCUTANEOUS

FORTEO

+ LILLY
0.6MG/2.4ML (0.25MG/ML)

N021318 002 Jun 25, 2008

TESAMORELIN ACETATE

POWDER;SUBCUTANEOUS

EGRIFTA

+ THERATECHNOLOGIES

N022505 001 Nov 10, 2010

EQ 1MG BASE/VIAL

TESTOSTERONE

FILM, EXTENDED RELEASE;TRANSDERMAL

ANDRODERM

+ ACTAVIS LABS UT INC
2MG/24HR
+
4MG/24HR
GEL;TRANSDERMAL

ANDROGEL

AB1
ABBVIE
25MG/2.5GM PACKET
AB1 +
50MG/5GM PACKET
TESTOSTERONE

AB1
ACTAVIS LABS UT INC
25MG/2.5GM PACKET
AB1
50MG/5GM PACKET
AB1
PAR PHARM
25MG/2.5GM PACKET
AB1
50MG/5GM PACKET
AB1
PERRIGO ISRAEL
25MG/2.5GM PACKET
AB1
50MG/5GM PACKET
TESTIM

AB2 + AUXILIUM PHARMS
50MG/5GM PACKET
VOGELXO

AB2
UPSHER SMITH
50MG/5GM PACKET
TESTOSTERONE

BX
ANI PHARMS INC
25MG/2.5GM PACKET
BX
50MG/5GM PACKET
ANDROGEL

ABBVIE
1.62% (20.25MG/1.25GM PACKET)
+
1.62% (40.5MG/2.5GM PACKET)
GEL, METERED;NASAL

NATESTO

ENDO VENTURES LTD
5.5MG/0.122GM ACTUATION
GEL, METERED;TRANSDERMAL

ANDROGEL

AB
+ ABBVIE
1.62% (20.25MG/1.25GM ACTUATION)
AB
+
12.5MG/1.25GM ACTUATION
FORTESTA

AB
+ ENDO PHARMS
10MG/0.5GM ACTUATION
TESTOSTERONE

AB
ACTAVIS LABS UT INC
10MG/0.5GM ACTUATION
AB
12.5MG/1.25GM ACTUATION
AB
PERRIGO ISRAEL
12.5MG/1.25GM ACTUATION
AB
1.62% (20.25MG/1.25GM ACTUATION)
VOGELXO

BX
UPSHER SMITH
12.5MG/1.25GM ACTUATION
PELLET;IMPLANTATION

TESTOPEL

+ ACTIENT PHARMS
75MG
SOLUTION, METERED;TRANSDERMAL

AXIRON

+ ELI LILLY AND CO
30MG/1.5ML ACTUATION
TABLET, EXTENDED RELEASE;BUCCAL

STRIANT

+ AUXILIUM PHARMS LLC
30MG

N020489 003 Oct 20, 2011

N020489 004 Oct 20, 2011

N021015 001 Feb 28, 2000

N021015 002 Feb 28, 2000

A076737
A076737
A076744
A076744
N203098
N203098

001
002
001
002
002
003

Jan
Jan
May
May
Jan
Jan

27,
27,
23,
23,
31,
31,

2006

2006

2007

2007

2013

2013

N021454 001 Oct 31, 2002

N204399 002 Jun 04, 2014

N202763 001 Feb 14, 2012

N202763 002 Feb 14, 2012

N022309 002 Sep 07, 2012

N022309 003 Sep 07, 2012

N205488 001 May 28, 2014

N022309 001 Apr 29, 2011

N021015 003 Sep 26, 2003

N021463 001 Dec 29, 2010

A204571
A076737
N203098
A204268

001
003
001
001

Aug
Mar
Jan
Aug

05,
09,
31,
04,

2015

2015

2013

2015

N204399 003 Jun 04, 2014

A080911 001

N022504 001 Nov 23, 2010

N021543 001 Jun 19, 2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-359(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION

DEPO-TESTOSTERONE

AO
+ PHARMACIA AND UPJOHN
AO
+
TESTOSTERONE CYPIONATE

AO
BEDFORD
AO
AO
HIKMA FARMACEUTICA
AO
MYLAN INSTITUTIONAL
AO
PADDOCK LLC
AO
SANDOZ
AO
AO
SUN PHARM INDS LTD
AO
AO
WATSON LABS
TESTOSTERONE ENANTHATE

INJECTABLE;INJECTION

DELATESTRYL

AO
+ ENDO PHARMS
TESTOSTERONE ENANTHATE

AO
HIKMA FARMACEUTICA
AO
MYLAN INSTITUTIONAL
AO
PADDOCK LLC
AO
WATSON LABS
TESTOSTERONE UNDECANOATE

INJECTABLE;INTRAMUSCULAR

AVEED

+ ENDO PHARMS INC
TETRABENAZINE

TABLET;ORAL

TETRABENAZINE

AB
SUN PHARMA GLOBAL
AB
XENAZINE

AB
VALEANT PHARMS NORTH
AB
+
TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

ACHROMYCIN V

AB
HERITAGE PHARMS INC
AB
+
TETRACYCLINE HYDROCHLORIDE

AB
IMPAX LABS
AB
AB
WATSON LABS
AB
IMPAX LABS

100MG/ML
200MG/ML

A085635 002

A085635 003

100MG/ML
200MG/ML
200MG/ML
200MG/ML
200MG/ML
100MG/ML
200MG/ML
100MG/ML
200MG/ML
200MG/ML

A090387
A090387
A091244
A040652
A040530
A040615
A040615
A201720
A201720
A086030

200MG/ML

N009165 003

200MG/ML
200MG/ML
200MG/ML
200MG/ML

A091120
A040647
A040575
A085598

750MG/3ML (250MG/ML)

N022219 001 Mar 05, 2014

12.5MG
25MG

A206129 001 Aug 17, 2015

A206129 002 Aug 17, 2015

12.5MG
25MG

N021894 001 Aug 15, 2008

N021894 002 Aug 15, 2008

250MG
500MG

N050278 003

N050278 001

250MG
500MG
250MG
500MG
100MG

A060469
A060469
A061837
A061837
A060469

TETRAHYDROZOLINE HYDROCHLORIDE

SOLUTION;NASAL

TYZINE

+ FOUGERA PHARMS
0.05%
0.1%
SPRAY;NASAL

TYZINE

+ FOUGERA PHARMS
0.1%
THALIDOMIDE

CAPSULE;ORAL

THALOMID

CELGENE

50MG
100MG
150MG
200MG

001
002
001
001
001
001
002
001
002
001

Jul
Jul
May
Dec
Jan
Aug
Aug
Jun
Jun

15,
15,
01,
11,
31,
10,
10,
03,
03,

2010

2010

2012

2006

2005

2006

2006

2013

2013

001 Sep 18, 2012

001 Oct 05, 2009

001 Jun 14, 2006

001

001

003

001

002

002

A086576 002

A086576 001

A086576 003

N020785
N020785
N020785
N020785

001
002
004
003

Jul
Jan
Jan
Jan

16,
17,
10,
17,

1998

2003

2007

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-360(of 388)

PRESCRIPTION DRUG PRODUCT LIST

THALLOUS CHLORIDE TL-201

INJECTABLE;INJECTION

THALLOUS CHLORIDE TL 201

AP
+ GE HEALTHCARE
AP
+ LANTHEUS MEDCL
AP
+ MALLINKRODT NUCLEAR
INJECTABLE;INTRAVENOUS

THALLOUS CHLORIDE TL 201

AP
+ LANTHEUS MEDCL

1mCi/ML
1mCi/ML
1mCi/ML

N018110 002 Feb 27, 1996

N017806 001

N018150 001

2mCi/ML

N017806 002 Oct 09, 1998

THEOPHYLLINE

CAPSULE, EXTENDED RELEASE;ORAL

THEO-24

ACTIENT PHARMS
100MG
200MG
300MG
+
400MG
INJECTABLE;INJECTION

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ B BRAUN
40MG/100ML
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ B BRAUN
80MG/100ML
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ B BRAUN
160MG/100ML
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ B BRAUN
320MG/100ML
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP
+ HOSPIRA INC
4MG/ML
AP
+
40MG/100ML
AP
+
160MG/100ML
AP
+
320MG/100ML
SOLUTION;ORAL

THEOPHYLLINE

AA
+ SILARX
80MG/15ML
AA
TRIS PHARMA INC
80MG/15ML
SOLUTION, ELIXIR;ORAL

ELIXOPHYLLIN

+ SUN PHARM INDS INC
80MG/15ML
TABLET, EXTENDED RELEASE;ORAL

THEOCHRON

AB
SUN PHARM INDS INC
100MG
AB
200MG
THEOPHYLLINE

AB
ALEMBIC LTD
300MG
AB
450MG
AB
GLENMARK GENERICS
400MG
AB
600MG
AB
MYLAN PHARMS INC
400MG
AB
+
600MG
AB
+ PLIVA
100MG
AB
+
200MG
AB
300MG
AB
RHODES PHARMS
600MG
AB
+ TEVA PHARMS
450MG
UNIPHYL

AB
RHODES PHARMS
400MG

A087571 001 Sep 01, 1982

THIAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

THIAMINE HYDROCHLORIDE

AP
+ FRESENIUS KABI USA
AP
MYLAN INSTITUTIONAL

100MG/ML
100MG/ML

A080556 001

A091623 001 Jun 25, 2012

THIOGUANINE

TABLET;ORAL

THIOGUANINE

+ ASPEN GLOBAL INC

40MG

N012429 001

A087942
A087943
A087944
A081034

001
001
001
001

Aug
Aug
Aug
Feb

22,
22,
22,
28,

1983

1983

1983

1992

N019826 001 Aug 14, 1992

N019826 002 Aug 14, 1992

N019826 003 Aug 14, 1992

N019826 006 Aug 14, 1992

N019211
N019211
N019211
N019211

007
001
003
006

Dec
Dec
Dec
Jan

14,
14,
14,
20,

1984

1984

1984

1988

A091156 001 Apr 13, 2011

A091586 001 Jun 15, 2012

A085186 001

A088320 001 Feb 21, 1985

A088321 001 Feb 21, 1985

A090430
A090430
A090355
A090355
A040560
A040560
A089807
A089808
A089763
A040086
A081236

001
002
001
002
003
002
001
001
001
001
001

Oct
Oct
Jul
Jul
Apr
Apr
Apr
Apr
Apr
Apr
Nov

27,
27,
13,
13,
21,
21,
30,
30,
30,
15,
09,

2010

2010

2010

2010

2006

2006

1990

1990

1990

1996

1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-361(of 388)

PRESCRIPTION DRUG PRODUCT LIST

THIORIDAZINE HYDROCHLORIDE

TABLET;ORAL

THIORIDAZINE HYDROCHLORIDE

AB
MUTUAL PHARM

AB

AB

AB

AB
MYLAN

AB

AB

AB
+

10MG

25MG

50MG

100MG

10MG

25MG

50MG

100MG

A089953
A089953
A089953
A089953
A088004
A088004
A088004
A088004

THIOTEPA

INJECTABLE;INJECTION

THIOTEPA

+ EUROHLTH INTL SARL

15MG/VIAL

A075547 001 Apr 02, 2001

1MG

2MG

5MG

10MG

N016584
N016584
N016584
N016584

001

002

003

004

1MG

2MG

5MG

10MG

1MG

2MG

5MG

10MG

A071093
A071093
A071093
A071093
A071610
A071570
A071529
A071530

002
003
004
001
001
001
001
001

1.1MG/VIAL

N020898 001 Nov 30, 1998

2MG

4MG

N020646 005 Apr 16, 1999

N020646 001 Sep 30, 1997

2MG

4MG

A077555 001 Nov 04, 2011

A077555 002 Nov 04, 2011

12MG

16MG

N020646 002 Sep 30, 1997

N020646 003 Sep 30, 1997

TICAGRELOR

TABLET;ORAL

BRILINTA

ASTRAZENECA LP

+

60MG

90MG

N022433 002 Sep 03, 2015

N022433 001 Jul 20, 2011

TICLOPIDINE HYDROCHLORIDE

TABLET;ORAL

TICLOPIDINE HYDROCHLORIDE

AB
APOTEX

AB
SUN PHARM INDS INC

AB
+ TEVA

250MG

250MG

250MG

A075089 001 Jul 01, 1999

A075526 001 Sep 26, 2002

A075149 001 Aug 20, 1999

50MG/VIAL

A091620 001 May 27, 2015

50MG/VIAL

N021821 001 Jun 15, 2005

THIOTHIXENE

CAPSULE;ORAL

NAVANE

AB
PFIZER

AB

AB
+

AB

THIOTHIXENE

AB
MYLAN

AB

AB

AB

AB
SANDOZ

AB

AB

AB

THYROTROPIN ALFA

INJECTABLE;INJECTION

THYROGEN

+ GENZYME

TIAGABINE HYDROCHLORIDE

TABLET;ORAL

GABITRIL

AB
CEPHALON

AB
+

TIAGABINE HYDROCHLORIDE

AB
SUN PHARM INDS

AB

GABITRIL

CEPHALON

TIGECYCLINE

INJECTABLE;IV (INFUSION)

TIGECYCLINE

AP
SANDOZ INC

TYGACIL

AP
+ PF PRISM CV

004
003
002
001
002
003
004
001

Aug
Aug
Aug
Oct
Mar
Mar
Mar
Nov

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

01,
01,
01,
07,
15,
15,
15,
18,

23,
23,
23,
23,
24,
24,
24,
24,

1986

1986

1986

1988

1983

1983

1983

1983

1987

1987

1987

1987

1987

1987

1987

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-362(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TIMOLOL

SOLUTION/DROPS;OPHTHALMIC

BETIMOL

+ OAK PHARMS INC
+

EQ 0.25% BASE
EQ 0.5% BASE

TIMOLOL MALEATE

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AB
ALCON RES LTD
EQ 0.25% BASE
AB
EQ 0.5% BASE
TIMOPTIC-XE

AB
+ VALEANT PHARMS LLC
EQ 0.25% BASE
AB
+
EQ 0.5% BASE
SOLUTION/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AT
ALCON RES LTD
EQ 0.25% BASE
AT
BAUSCH AND LOMB
EQ 0.25% BASE
AT
FDC LTD
EQ 0.25% BASE
AT
PACIFIC PHARMA
EQ 0.25% BASE
AT
WOCKHARDT
EQ 0.25% BASE
TIMOPTIC

AT
+ ATON
EQ 0.25% BASE
TIMOLOL MALEATE

AT1
AKORN
EQ 0.5% BASE
AT1
EQ 0.5% BASE
AT1
ALCON RES LTD
EQ 0.5% BASE
AT1
BAUSCH AND LOMB
EQ 0.5% BASE
AT1
FDC LTD
EQ 0.5% BASE
AT1
HI TECH PHARMA
EQ 0.5% BASE
AT1
PACIFIC PHARMA
EQ 0.5% BASE
AT1
WOCKHARDT
EQ 0.5% BASE
TIMOPTIC

AT1 + ATON
EQ 0.5% BASE
ISTALOL

AT2 + BAUSCH AND LOMB
EQ 0.5% BASE
TIMOLOL MALEATE

AT2
APOTEX INC
EQ 0.5% BASE
TIMOPTIC IN OCUDOSE

+ ATON
EQ 0.25% BASE
+
EQ 0.5% BASE
TABLET;ORAL

TIMOLOL MALEATE

MYLAN
5MG
10MG
+
20MG

N020439 001 Mar 31, 1995

N020439 002 Mar 31, 1995

N020963 001 Oct 21, 1998

N020963 002 Oct 21, 1998

N020330 001 Nov 04, 1993

N020330 002 Nov 04, 1993

A074261
A074778
A077259
A074746
A078771

001
001
001
001
001

Apr
Mar
Apr
Mar
Sep

28,
25,
30,
25,
28,

1995

1997

2008

1997

2009

Mar
Mar
Apr
Mar
Apr
Sep
Mar
Sep

25,
25,
28,
25,
30,
10,
25,
28,

1997

1997

1995

1997

2008

2002

1997

2009

N018086 001

A074466
A074516
A074262
A074776
A077259
A075163
A074747
A078771

001
001
001
001
002
001
001
002

N018086 002

N021516 001 Jun 04, 2004

A204936 001 Apr 17, 2015

N019463 001 Nov 05, 1986

N019463 002 Nov 05, 1986

A072668 002 Jun 08, 1990

A072668 003 Jun 08, 1990

A072668 001 Jun 08, 1990

TINIDAZOLE

TABLET;ORAL

TINDAMAX

AB
MISSION PHARMA
AB
+
TINIDAZOLE

AB
EDENBRIDGE PHARMS
AB
AB
NOVEL LABS INC
AB
AB
ROXANE
AB
AB
UNIQUE PHARM LABS
AB

250MG
500MG

N021618 001 May 17, 2004

N021618 002 May 17, 2004

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A203808
A203808
A202044
A202044
A201172
A201172
A202489
A202489

TIOPRONIN

TABLET;ORAL

THIOLA

+ MISSION PHARMA

100MG

N019569 001 Aug 11, 1988

EQ 0.018MG BASE/INH

N021395 001 Jan 30, 2004

EQ 0.00125MG BASE/INH

N021936 002 Sep 15, 2015

TIOTROPIUM BROMIDE

POWDER;INHALATION

SPIRIVA

+ BOEHRINGER INGELHEIM
SPRAY, METERED;INHALATION

SPIRIVA RESPIMAT

BOEHRINGER INGELHEIM

001
002
001
002
001
002
001
002

Aug
Aug
Apr
Apr
Apr
Apr
Oct
Oct

04,
04,
30,
30,
30,
30,
09,
09,

2015

2015

2012

2012

2012

2012

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-363(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TIOTROPIUM BROMIDE

SPRAY, METERED;INHALATION

SPIRIVA RESPIMAT

+

EQ 0.0025MG BASE/INH

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

TABLET;ORAL

LONSURF

TAIHO ONCOLOGY
EQ 6.14MG BASE;15MG
+
EQ 8.19MG BASE;20MG
TIPRANAVIR

CAPSULE;ORAL

APTIVUS

+ BOEHRINGER INGELHEIM
SOLUTION;ORAL

APTIVUS

+ BOEHRINGER INGELHEIM
TIROFIBAN HYDROCHLORIDE

INJECTABLE;INJECTION

AGGRASTAT

MEDICURE
+
TIZANIDINE HYDROCHLORIDE

CAPSULE;ORAL

TIZANIDINE HYDROCHLORIDE

AB
APOTEX INC
AB
AB
AB
MYLAN PHARMS INC
AB
AB
ZANAFLEX

AB
ACORDA
AB
AB
+
TABLET;ORAL

TIZANIDINE HYDROCHLORIDE

AB
APOTEX
AB
AB
COREPHARMA
AB
AB
DR REDDYS LABS INC
AB
AB
MYLAN
AB
AB
PROSAM LABS
AB
AB
SANDOZ INC
AB
AB
SUN PHARM INDS INC
AB
AB
TEVA
AB
AB
UNICHEM LABS LTD
AB
ZANAFLEX

AB
+ ACORDA
TOBRAMYCIN

OINTMENT;OPHTHALMIC

TOBREX

+ ALCON
POWDER;INHALATION

TOBI PODHALER

+ NOVARTIS
SOLUTION;INHALATION

KITABIS PAK

AN
PULMOFLOW INC
TOBI

AN
+ NOVARTIS PHARMS

N021936 001 Sep 24, 2014

N207981 001 Sep 22, 2015

N207981 002 Sep 22, 2015

250MG

N021814 001 Jun 22, 2005

100MG/ML

N022292 001 Jun 23, 2008

EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)

EQ 12.5MG BASE/250ML (EQ 0.05MG
BASE/ML)

N020913 002 May 17, 2002

N020913 003 Apr 20, 2000

EQ
EQ
EQ
EQ
EQ
EQ

A078868
A078868
A078868
A091502
A091502
A091502

2MG
4MG
6MG
2MG
4MG
6MG

BASE
BASE
BASE
BASE
BASE
BASE

001
002
003
001
002
003

Feb
Feb
Feb
Nov
Nov
Nov

03,
03,
03,
09,
09,
09,

2012

2012

2012

2012

2012

2012

EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE

N021447 001 Aug 29, 2002

N021447 002 Aug 29, 2002

N021447 003 Aug 29, 2002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A076533
A076533
A076347
A076347
A076286
A076286
A076354
A076354
A076281
A076281
A076280
A076280
A076416
A076416
A076284
A076284
A091283
A091283

2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Jan
Jan
Oct
Oct
Jul
Jul
Mar
Mar
Oct
Oct
Nov
Jun
Sep
Sep
Jul
Jul
Nov
Nov

16,
16,
11,
11,
03,
03,
28,
28,
20,
20,
26,
27,
29,
29,
03,
03,
28,
28,

2004

2004

2002

2002

2002

2002

2003

2003

2003

2003

2002

2002

2003

2003

2002

2002

2012

2012

EQ 4MG BASE

N020397 001 Nov 27, 1996

0.3%

N050555 001

28MG

N201688 001 Mar 22, 2013

300MG/5ML

N205433 001 Dec 02, 2014

300MG/5ML

N050753 001 Dec 22, 1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-364(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TOBRAMYCIN

SOLUTION;INHALATION

TOBRAMYCIN

AN
AKORN INC
AN
AMNEAL PHARMS
AN
TEVA PHARMS USA
BETHKIS

CHIESI USA INC
SOLUTION/DROPS;OPHTHALMIC

AKTOB

AT
AKORN
TOBRAMYCIN

AT
BAUSCH AND LOMB
AT
FERA PHARMS
TOBREX

AT
ALCON
AT
+ ALCON LABS INC

300MG/5ML
300MG/5ML
300MG/5ML

A201422 001 May 28, 2014

A205501 001 Jul 13, 2015

A091589 001 Oct 10, 2013

300MG/4ML

N201820 001 Oct 12, 2012

0.3%

A064096 001 Jan 31, 1996

0.3%
0.3%

A064052 001 Nov 29, 1993

A065026 001 Sep 11, 2001

0.3%
0.3%

A062535 001 Dec 13, 1984

N050541 001

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION

TOBRAMYCIN SULFATE

AP
AKORN
EQ 40MG BASE/ML
AP
FRESENIUS KABI USA
EQ 10MG BASE/ML
AP
+
EQ 40MG BASE/ML
AP
EQ 1.2GM BASE/VIAL
AP
HIKMA MAPLE
EQ 40MG BASE/ML
AP
+ HOSPIRA
EQ 10MG BASE/ML
AP
EQ 40MG BASE/ML
AP
MYLAN LABS LTD
EQ 40MG BASE/ML
AP
TEVA PHARMS USA
EQ 40MG BASE/ML
AP
+ X GEN PHARMS
EQ 1.2GM BASE/VIAL
AP
XELLIA PHARMS APS
EQ 1.2GM BASE/VIAL
TOBRAMYCIN SULFATE (PHARMACY BULK)

+ FRESENIUS KABI USA

EQ 40MG BASE/ML
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ HOSPIRA
EQ 1.2MG BASE/ML
+
EQ 1.6MG BASE/ML
+
EQ 80MG BASE/100ML

A205179
A065122
A065122
N050789
A063117
A063112
A063111
A065407
A063100
A065013
A205685

001
001
002
001
001
001
001
001
001
001
001

Sep
Nov
Nov
Jul
Apr
Apr
Apr
Mar
Jan
Aug
Sep

16,
29,
29,
13,
26,
30,
30,
11,
30,
17,
16,

2014

2002

2002

2004

1991

1991

1991

2008

1992

2001

2014

A065120 001 Nov 29, 2002

A063081 003 Jul 31, 1990

A063081 006 Jun 02, 1993

A063081 001 Jul 31, 1990

TOFACITINIB CITRATE

TABLET;ORAL

XELJANZ

+ PF PRISM CV

EQ 5MG BASE

N203214 001 Nov 06, 2012

TOLAZAMIDE

TABLET;ORAL

TOLAZAMIDE

MYLAN PHARMS INC
+

250MG
500MG

A070259 001 Jan 02, 1986

A070259 003 Mar 17, 1986

TOLBUTAMIDE

TABLET;ORAL

TOLBUTAMIDE

+ MYLAN PHARMS INC

500MG

A086445 001

100MG

N020697 001 Jan 29, 1998

100MG

A204584 001 Mar 26, 2015

EQ 400MG BASE
EQ 400MG BASE

A073393 001 May 27, 1993

A073290 001 Nov 27, 1991

EQ 200MG BASE
EQ 600MG BASE

A073310 001 Nov 27, 1991

A074473 001 Aug 30, 1994

TOLCAPONE

TABLET;ORAL

TASMAR

AB
+ VALEANT PHARMS LLC
TOLCAPONE

AB
PAR PHARM INC
TOLMETIN SODIUM

CAPSULE;ORAL

TOLMETIN SODIUM

AB
MYLAN
AB
+ TEVA
TABLET;ORAL

TOLMETIN SODIUM

AB
MUTUAL PHARM
AB
+ MYLAN

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-365(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TOLTERODINE TARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

DETROL LA

AB
PHARMACIA AND UPJOHN
2MG
AB
+
4MG
TOLTERODINE TARTRATE

AB
MYLAN PHARMS INC
2MG
AB
4MG
AB
TORRENT PHARMS LTD
2MG
AB
4MG
TABLET;ORAL

DETROL

AB
PHARMACIA AND UPJOHN
1MG
AB
+
2MG
TOLTERODINE TARTRATE

AB
APOTEX CORP
1MG
AB
2MG
AB
IVAX SUB TEVA PHARMS
1MG
AB
2MG
AB
MACLEODS PHARMS LTD
1MG
AB
2MG
AB
MYLAN PHARMS INC
1MG
AB
2MG

A200164
A200164
A077006
A077006
A203409
A203409
A202641
A202641

TOLVAPTAN

TABLET;ORAL

SAMSCA

OTSUKA AMERICA PHARM
+

N022275 001 May 19, 2009

N022275 002 May 19, 2009

15MG
30MG

TOPIRAMATE

CAPSULE;ORAL

TOPAMAX

AB
JANSSEN PHARMS
15MG
AB
+
25MG
TOPIRAMATE

AB
MYLAN
15MG
AB
25MG
AB
TEVA
15MG
AB
25MG
AB
WATSON LABS
15MG
AB
25MG
AB
ZYDUS PHARMS USA INC
15MG
AB
25MG
CAPSULE, EXTENDED RELEASE;ORAL

QUDEXY XR

UPSHER SMITH
25MG
50MG
100MG
150MG
+
200MG
TROKENDI XR

SUPERNUS PHARMS
25MG
50MG
100MG
+
200MG
TABLET;ORAL

TOPAMAX

AB
JANSSEN PHARMS
25MG
AB
50MG
AB
+
100MG
AB
200MG
TOPIRAMATE

AB
ACCORD HLTHCARE
25MG
AB
50MG
AB
100MG
AB
200MG
AB
ACTIVIS TOTOWA LLC
25MG
AB
50MG
AB
100MG
AB
200MG
AB
APOTEX INC
25MG
AB
50MG

N021228 001 Dec 22, 2000

N021228 002 Dec 22, 2000

A201486
A201486
A203016
A203016

001
002
001
002

Oct
Oct
Aug
Aug

31,
31,
11,
11,

2013

2013

2015

2015

N020771 001 Mar 25, 1998

N020771 002 Mar 25, 1998

001
002
001
002
001
002
001
002

Sep
Sep
Feb
Feb
Aug
Aug
Nov
Nov

25,
25,
23,
23,
31,
31,
27,
27,

2012

2012

2015

2015

2015

2015

2012

2012

N020844 001 Oct 26, 1998

N020844 002 Oct 26, 1998

A078418
A078418
A076575
A076575
A077868
A077868
A078877
A078877

001
002
001
002
001
002
001
002

Oct
Oct
Apr
Apr
Apr
Apr
Oct
Oct

14,
14,
17,
17,
15,
15,
14,
14,

2009

2009

2009

2009

2009

2009

2009

2009

N205122
N205122
N205122
N205122
N205122

001
002
003
004
005

Mar
Mar
Mar
Mar
Mar

11,
11,
11,
11,
11,

2014

2014

2014

2014

2014

N201635
N201635
N201635
N201635

001
002
003
004

Aug
Aug
Aug
Aug

16,
16,
16,
16,

2013

2013

2013

2013

N020505
N020505
N020505
N020505

004
005
001
002

Dec
Dec
Dec
Dec

24,
24,
24,
24,

1996

1996

1996

1996

A076311
A076311
A076311
A076311
A078637
A078637
A078637
A078637
A077733
A077733

001
002
003
004
001
002
003
004
001
002

Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Mar
Mar

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2009

2009

2009

2009

2013

2013

2013

2013

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-366(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TOPIRAMATE

TABLET;ORAL

TOPIRAMATE
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
CIPLA LTD
AB
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
AB
LUPIN
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
SUN PHARMA GLOBAL
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
AB
UNICHEM LABS LTD
AB
AB
AB
AB
UPSHER SMITH
AB
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
AB
TOPOTECAN HYDROCHLORIDE

CAPSULE;ORAL

HYCAMTIN

NOVARTIS PHARMS CORP

+

INJECTABLE;INJECTION

HYCAMTIN

AP
+ NOVARTIS PHARMS CORP

TOPOTECAN HYDROCHLORIDE

AP
ACCORD HLTHCARE

AP
ACTAVIS TOTOWA

AP
CHEM WERTH INC

AP
CIPLA LTD

AP
DR REDDYS LABS LTD

AP
FRESENIUS KABI USA

AP
MYLAN LABS LTD

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

25MG

50MG

100MG

200MG

A077733
A077733
A078462
A078462
A078462
A078462
A076343
A076343
A076343
A076343
A077627
A077627
A077627
A077627
A079162
A079162
A079162
A079162
A078410
A078410
A078410
A078410
A076314
A076314
A076314
A076314
A076327
A076327
A076327
A090278
A090278
A090278
A090278
A076317
A076317
A076317
A076317
A079153
A079153
A079153
A079153
A090162
A090162
A090162
A090162
A078499
A078499
A078499
A078499
A078235
A078235
A078235
A078235

EQ 0.25MG BASE

EQ 1MG BASE

N020981 001 Oct 11, 2007

N020981 002 Oct 11, 2007

EQ 4MG BASE/VIAL

N020671 001 May 28, 1996

EQ
EQ
EQ
EQ
EQ
EQ
EQ

A202351
A090620
A201166
A091199
A201191
A091089
A091542

4MG
4MG
4MG
4MG
4MG
4MG
4MG

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

001
001
001
001
001
001
001

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Feb
Jan
Jan
Jan
Jan
Mar
Mar
Mar
Mar

Jun
Dec
Aug
Dec
Mar
Nov
Aug

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
11,
11,
11,
11,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
19,
07,
07,
07,
07,
27,
27,
27,
27,

26,
02,
08,
01,
09,
29,
28,

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2013

2013

2013

2013

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2013

2010

2010

2010

2010

2009

2009

2009

2009

2013

2010

2012

2010

2011

2010

2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-367(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TOPOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

TOPOTECAN HYDROCHLORIDE

AP
SAGENT PHARMS

AP
SUN PHARM INDS LTD

SOLUTION;INTRAVENOUS

TOPOTECAN HYDROCHLORIDE

AP
+ HOSPIRA INC

AP
TEVA PHARMS USA

TOREMIFENE CITRATE

TABLET;ORAL

FARESTON

+ PROSTRAKAN INC

TORSEMIDE

TABLET;ORAL

DEMADEX

AB
MEDA PHARMS

AB

AB
+

AB

TORSEMIDE

AB
APOTEX INC

AB

AB

AB

AB
AUROBINDO PHARMA

AB

AB

AB

AB
HETERO LABS LTD III

AB

AB

AB

AB
PAR PHARM

AB

AB

AB

AB
PLIVA PHARM IND

AB

AB

AB

AB
ROXANE

AB

AB

AB
SUN PHARM INDS

AB

AB

AB

AB
TEVA

AB

AB

AB

AB
VINTAGE PHARMS

AB

AB

AB

TRABECTEDIN

POWDER;IV (INFUSION)

YONDELIS

+ JANSSEN PRODS

EQ 4MG BASE/VIAL

EQ 4MG BASE/VIAL

A091284 001 Jan 26, 2011

A202203 001 Aug 29, 2013

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

N200582 001 Feb 02, 2011

N022453 001 Dec 20, 2012

EQ 60MG BASE

N020497 001 May 29, 1997

5MG

10MG

20MG

100MG

N020136
N020136
N020136
N020136

001
002
003
004

Aug
Aug
Aug
Aug

23,
23,
23,
23,

1993

1993

1993

1993

5MG

10MG

20MG

100MG

5MG

10MG

20MG

100MG

5MG

10MG

20MG

100MG

5MG

10MG

20MG

100MG

5MG

10MG

20MG

100MG

5MG

10MG

20MG

5MG

10MG

20MG

100MG

5MG

10MG

20MG

100MG

5MG

10MG

20MG

100MG

A076894
A076894
A076894
A076894
A078249
A078249
A078249
A078249
A079234
A079234
A079234
A079234
A076226
A076226
A076226
A076226
A076346
A076346
A076346
A076346
A076943
A076943
A076943
A078478
A078478
A078478
A078478
A076110
A076110
A076110
A076110
A090613
A090613
A090613
A090613

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004
001
002
003
004
001
002
003
004

May
May
May
May
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
May
May
May
May
May
May
May
Oct
Mar
Mar
Mar
Feb
Feb
Feb
Feb
May
May
May
May
Mar
Mar
Mar
Mar

31,
31,
31,
31,
17,
17,
17,
17,
27,
27,
27,
27,
27,
27,
27,
27,
30,
30,
30,
19,
01,
01,
01,
26,
26,
26,
26,
14,
14,
14,
14,
22,
22,
22,
22,

2005

2005

2005

2005

2007

2007

2007

2007

2009

2009

2009

2009

2003

2003

2003

2003

2003

2003

2003

2004

2005

2005

2005

2008

2008

2008

2008

2002

2002

2002

2002

2011

2011

2011

2011

1MG/VIAL

N207953 001 Oct 23, 2015

TRAMADOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CONZIP

+ CIPHER PHARMS INC
100MG
150MG
200MG
300MG
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
AB
ACCORD HLTHCARE INC
50MG

N022370
N022370
N022370
N022370

001
004
002
003

May
Aug
May
May

07,
01,
07,
07,

2010

2011

2010

2010

A202390 001 May 16, 2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-368(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TRAMADOL HYDROCHLORIDE

TABLET;ORAL

TRAMADOL HYDROCHLORIDE

AB
ALLIED PHARMA INC

50MG

AB
AMNEAL PHARMS

50MG

AB
APOTEX

50MG

AB
AUROBINDO PHARMA LTD
50MG

AB
CSPC OUYI PHARM CO

50MG

AB
IPCA LABS LTD

50MG

AB
MACLEODS PHARMS LTD

50MG

AB
MALLINCKRODT

50MG

AB
MUTUAL PHARM

50MG

AB
MYLAN

50MG

AB
MYLAN PHARMS INC

50MG

AB
NORTHSTAR HLTHCARE

50MG

AB
PLIVA

50MG

AB
SUN PHARM INDS INC

50MG

AB
TEVA

50MG

AB
ZYDUS PHARMS USA INC
50MG

ULTRAM

AB
+ JANSSEN PHARMS

50MG

TABLET, EXTENDED RELEASE;ORAL

TRAMADOL HYDROCHLORIDE

AB1
AUROBINDO PHARMA LTD
100MG

AB1

200MG

AB1

300MG

AB1
LUPIN LTD

100MG

AB1

200MG

AB1

300MG

AB1
MYLAN PHARMS INC

100MG

AB1

200MG

AB1

300MG

AB1
PAR PHARM INC

100MG

AB1

200MG

AB1

300MG

AB1
SUN PHARMA GLOBAL

100MG

AB1

200MG

AB1

300MG

ULTRAM ER

AB1 + VALEANT INTL

100MG

AB1

200MG

AB1

300MG

TRAMADOL HYDROCHLORIDE

AB2
ACTAVIS ELIZABETH

100MG

AB2

200MG

AB2

300MG

AB2
ANCHEN PHARMS

100MG

AB2

200MG

AB2

300MG

AB2 + SUN PHARMA GLOBAL

100MG

AB2

200MG

AB2

300MG

TRAMETINIB DIMETHYL SULFOXIDE

TABLET;ORAL

MEKINIST

NOVARTIS PHARMS CORP

+

TRANDOLAPRIL

TABLET;ORAL

MAVIK

AB
ABBVIE

AB

AB
+

TRANDOLAPRIL

AB
AUROBINDO PHARMA

AB

AB

AB
EPIC PHARMA

AB

AB

A202075
A076003
A075981
A203494
A091498
A201973
A205702
A075983
A076100
A075986
A075980
A078935
A075982
A075964
A075977
A090404

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Nov
Jun
Jul
Mar
Mar
Nov
Sep
Jun
Jun
Jun
Nov
May
Jul
Jun
Jun
Jan

28,
20,
10,
31,
29,
16,
25,
25,
20,
21,
21,
26,
01,
19,
19,
31,

2011

2002

2002

2014

2013

2012

2015

2002

2002

2002

2002

2010

2002

2002

2002

2011

N020281 002 Mar 03, 1995

A204421
A204421
A204421
A200503
A200503
A200503
A205257
A205257
A205257
A078783
A078783
A078783
A201384
A201384
A201384

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Oct
Oct
Oct
Aug
Aug
Aug
Dec
Dec
Dec
Nov
Nov
Sep
Dec
Dec
Dec

20,
20,
20,
29,
29,
29,
22,
22,
22,
13,
13,
20,
07,
07,
07,

2015

2015

2015

2011

2011

2011

2015

2015

2015

2009

2009

2011

2011

2011

2011

N021692 001 Sep 08, 2005

N021692 002 Sep 08, 2005

N021692 003 Sep 08, 2005

A091609
A091609
A091609
A200491
A200491
A200491
A091607
A091607
A091607

001
002
003
001
002
003
001
002
003

Jun
Jun
Jun
Jun
Jun
Jun
Dec
Dec
Dec

27,
27,
27,
27,
27,
27,
30,
30,
30,

2012

2012

2012

2012

2012

2012

2011

2011

2011

EQ 0.5MG

EQ 1MG

EQ 2MG

N204114 001 May 29, 2013

N204114 002 May 29, 2013

N204114 003 May 29, 2013

1MG

2MG

4MG

N020528 001 Apr 26, 1996

N020528 002 Apr 26, 1996

N020528 003 Apr 26, 1996

1MG

2MG

4MG

1MG

2MG

4MG

A078438
A078438
A078438
A078508
A078508
A078508

001
002
003
003
001
002

Jun
Jun
Jun
Jun
Jun
Jun

12,
12,
12,
18,
18,
18,

2007

2007

2007

2008

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-369(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TRANDOLAPRIL

TABLET;ORAL

TRANDOLAPRIL
AB
INVAGEN PHARMS
AB
AB
AB
LUPIN
AB
AB
AB
MYLAN
AB
AB
AB
TEVA PHARMS
AB
AB
AB
WATSON LABS
AB
AB

1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

TARKA

AB
ABBVIE
1MG;240MG

AB
2MG;180MG

AB
2MG;240MG

AB
+
4MG;240MG

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE

AB
GLENMARK GENERICS

1MG;240MG

AB

2MG;180MG

AB

2MG;240MG

AB

4MG;240MG

TRANEXAMIC ACID

INJECTABLE;INJECTION

CYKLOKAPRON

AP
+ PHARMACIA AND UPJOHN

TRANEXAMIC ACID

AP
ACIC FINE CHEMS

AP
EMCURE PHARMS LTD

AP
FRESENIUS KABI USA

AP
LUITPOLD

AP
MYLAN INSTITUTIONAL

AP
VERSAPHARM INC

AP
X-GEN PHARMS INC

TABLET;ORAL

LYSTEDA

AB
+ FERRING PHARMS AS

TRANEXAMIC ACID

AB
ACTAVIS LABS FL INC

AB
APOTEX INC

AB
MYLAN

TRANYLCYPROMINE SULFATE

TABLET;ORAL

PARNATE

AB
+ CONCORDIA PHARMS INC

TRANYLCYPROMINE SULFATE

AB
PAR PHARM

TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC

TRAVATAN Z

AT
+ ALCON PHARMS LTD

TRAVOPROST

AT
APOTEX INC

+ PAR PHARM

TRAZODONE HYDROCHLORIDE

TABLET;ORAL

TRAZODONE HYDROCHLORIDE

AB
ALVOGEN
AB
AB
APOTEX
AB
+ APOTEX INC
AB

A078320
A078320
A078320
A077522
A077522
A077522
A078346
A078346
A078346
A077489
A077489
A077489
A077805
A077805
A077805

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Dec
Dec
Dec
Jun
Jun
Jun

12,
12,
12,
12,
12,
12,
28,
28,
28,
12,
12,
12,
12,
12,
12,

2007

2007

2007

2007

2007

2007

2008

2008

2008

2006

2006

2006

2007

2007

2007

N020591
N020591
N020591
N020591

003
001
004
002

Oct
Oct
Oct
Oct

22,
22,
22,
22,

1996

1996

1996

1996

A079135
A079135
A079135
A079135

004
001
002
003

Aug
May
May
May

30,
26,
26,
05,

2010

2010

2010

2010

100MG/ML

N019281 001 Dec 30, 1986

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

A202436
A203521
A091596
A201885
A091657
A202373
A201580

650MG

N022430 001 Nov 13, 2009

650MG

650MG

650MG

A202093 001 Dec 27, 2012

A202286 001 Jan 27, 2014

A205133 001 Sep 21, 2015

EQ 10MG BASE

N012342 003 Aug 16, 1985

EQ 10MG BASE

A040640 001 Jun 29, 2006

0.004%

N021994 001 Sep 21, 2006

0.004%

0.004%

A203431 001 Jul 10, 2015

A091340 001 Mar 01, 2013

50MG

100MG

50MG

100MG

150MG

A071636
A071514
A071258
A071196
A071196

001
001
001
001
001
001
001

001
001
001
001
002

Feb
Aug
Mar
Aug
Nov
Nov
Jun

Apr
Apr
Mar
Mar
Apr

11,
12,
02,
10,
03,
17,
14,

18,
18,
25,
25,
26,

2014

2014

2012

2011

2011

2011

2013

1988

1988

1987

1987

1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-370(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TRAZODONE HYDROCHLORIDE

TABLET;ORAL

TRAZODONE HYDROCHLORIDE

AB
AB
MUTUAL PHARM
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
PLIVA
AB
TEVA PHARMS USA
AB
AB
TORRENT PHARMS LTD
AB
AB
AB
AB
VINTAGE
AB

300MG
50MG
100MG
150MG
50MG
100MG
150MG
300MG
150MG
50MG
100MG
50MG
100MG
150MG
300MG
50MG
100MG

A071196
A073137
A073137
A073137
A090514
A090514
A090514
A090514
A071525
A071523
A071524
A202180
A202180
A202180
A202180
A072192
A072193

003
002
001
003
001
002
003
004
001
001
001
001
002
003
004
001
001

Apr
Mar
Mar
Dec
Jun
Jun
Jun
Jun
Mar
Dec
Dec
Nov
Nov
Nov
Nov
Feb
Feb

26,
24,
24,
22,
02,
02,
02,
02,
09,
11,
11,
27,
27,
27,
27,
02,
02,

1999

1993

1993

1995

2009

2009

2009

2009

1988

1987

1987

2013

2013

2013

2013

1989

1989

N021272
N021272
N021272
N021272

001
002
003
004

May
May
May
May

21,
21,
21,
21,

2002

2002

2002

2002

TREPROSTINIL

INJECTABLE;IV (INFUSION), SUBCUTANEOUS

REMODULIN

UNITED THERAP
1MG/ML
2.5MG/ML
5MG/ML
+
10MG/ML
SOLUTION;INHALATION

TYVASO

+ UNITED THERAP
0.6MG/ML

N022387 001 Jul 30, 2009

TREPROSTINIL DIOLAMINE

TABLET, EXTENDED RELEASE;ORAL

ORENITRAM

UNITED THERAP
EQ
EQ
EQ
+
EQ

N203496
N203496
N203496
N203496

TRETINOIN

CAPSULE;ORAL

TRETINOIN

AB
ANCHEN PHARMS
AB
+ BARR LABS INC
CREAM;TOPICAL

AVITA

AB
MYLAN PHARMS INC
RETIN-A

AB
+ VALEANT BERMUDA
AB
+ VALEANT PHARMS NORTH
TRETINOIN

AB
MATAWAN PHARMS
AB
RETIN-A

AB1 + VALEANT BERMUDA
TRETINOIN

AB1
MATAWAN PHARMS
RENOVA

AB2 + VALEANT PHARMS NORTH
TRETINOIN

AB2
SUNEVA MEDCL
RENOVA

+ VALEANT PHARMS NORTH
TRETINOIN

+ WATSON LABS INC
GEL;TOPICAL

ATRALIN

AB
+ DOW PHARM
RETIN-A

AB
+ VALEANT INTL
AB
+

0.125MG BASE
0.25MG BASE
1MG BASE
2.5MG BASE

001
002
003
004

Dec
Dec
Dec
Dec

20,
20,
20,
20,

2013

2013

2013

2013

10MG
10MG

A201687 001 Oct 24, 2012

A077684 001 Jun 22, 2007

0.025%

N020404 003 Jan 14, 1997

0.025%
0.1%

N019049 001 Sep 16, 1988

N017340 001

0.025%
0.1%

A075264 001 Dec 24, 1998

A075213 001 Dec 24, 1998

0.05%

N017522 001

0.05%

A075265 001 Dec 24, 1998

0.05%

N019963 001 Dec 29, 1995

0.05%

A076498 001 Sep 15, 2005

0.02%

N021108 001 Aug 31, 2000

0.0375%
0.075%

A090098 001 Mar 22, 2010

A202209 001 Oct 11, 2012

0.05%

N022070 001 Jul 26, 2007

0.01%
0.025%

N017955 001

N017579 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-371(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TRETINOIN

GEL;TOPICAL

RETIN-A MICRO

AB
+ VALEANT INTL
AB
+
TRETINOIN

AB
MATAWAN PHARMS
AB
AB
SPEAR PHARMS INC
AB
AB
AVITA

BT
MYLAN
RETIN-A-MICRO

+ VALEANT INTL
SOLUTION;TOPICAL

RETIN-A

+ VALEANT INTL

0.04%
0.1%

N020475 002 May 10, 2002

N020475 001 Feb 07, 1997

0.01%
0.025%
0.04%
0.05%
0.1%

A075589
A075529
A202567
A207955
A202026

0.025%

N020400 001 Jan 29, 1998

0.08%

N020475 003 Jan 28, 2014

0.05%

N016921 001

TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

TRIAMCINOLONE ACETONIDE

AT
+ FOUGERA PHARMS
0.025%
AT
+
0.1%
AT
+
0.5%
AT
G AND W LABS
0.025%
AT
0.1%
AT
PERRIGO NEW YORK
0.025%
AT
0.1%
AT
0.5%
AT
TARO
0.1%
AT
VINTAGE
0.025%
AT
0.1%
TRIDERM

AT
CROWN LABS
0.025%
AT
0.1%
AT
0.5%
INJECTABLE;INJECTION

KENALOG-10

APOTHECON
10MG/ML
KENALOG-40

+ APOTHECON
40MG/ML
INJECTABLE;INTRAVITREAL

TRIESENCE

+ ALCON
40MG/ML (40MG/ML)
LOTION;TOPICAL

TRIAMCINOLONE ACETONIDE

AT
FOUGERA PHARMS
0.025%
AT
0.1%
AT
G AND W LABS INC
0.1%
AT
VERSAPHARM INC
0.025%
AT
0.1%
AT
VINTAGE
0.1%
AT
+ WOCKHARDT
0.1%
AT
+ WOCKHARDT EU OPERATN
0.025%
OINTMENT;TOPICAL

KENALOG

AT
DELCOR ASSET CORP
0.025%
AT
0.1%
TRIAMCINOLONE ACETONIDE

AT
FOUGERA PHARMS
0.025%
AT
0.1%
AT
0.5%
AT
G AND W LABS
0.025%
AT
0.1%
AT
+ PERRIGO NEW YORK
0.025%
AT
+
0.1%
AT
+
0.5%
AT
TARO
0.1%
TRIAMCINOLONE ACETONIDE IN ABSORBASE

+ CAROLINA MEDCL
0.05%

A085692
A085692
A085692
A089797
A089798
A086415
A086414
A086413
A040039
A040671
A040671

001
001
001
001
001

001

003

002

001
001
001

001

001

001
001
002

Jun
Feb
Jul
Aug
Jul

11,
22,
17,
13,
17,

2002

2000

2013

2015

2013

May 31, 1991

May 31, 1991

Nov 26, 1997

Jun 09, 2006

Jun 09, 2006

A088042 002 Mar 25, 2015

A088042 001 Mar 19, 1984

A088042 003 Mar 25, 2015

N012041 001

N014901 001

N022048 001 Nov 29, 2007

A040467
A040467
A089129
A202374
A202374
A040672
A088451
A088450

001
002
001
001
002
002
001
001

Apr
Apr
Aug
May
May
Dec
Apr
Apr

21,
21,
14,
08,
08,
13,
03,
01,

2003

2003

1986

2013

2013

2006

1985

1985

N011600 003

N011600 001

A085691
A085691
A085691
A089795
A089796
A087356
A087357
A087385
A040037

001

003

002

001 Dec 23, 1988

001 Dec 23, 1988

001

001

001

001 Sep 30, 1994

A089595 001 Mar 23, 1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-372(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TRIAMCINOLONE ACETONIDE

PASTE;DENTAL

TRIAMCINOLONE ACETONIDE

AT
LYNE

AT
+ TARO

SPRAY;TOPICAL

KENALOG
AT
+ SUN PHARM INDS LTD
TRIAMCINOLONE ACETONIDE
AT
PERRIGO UK FINCO
SPRAY, METERED;NASAL

TRIAMCINOLONE ACETONIDE

TEVA PHARMS

0.1%

0.1%

A040771 001 Jul 01, 2010

A070730 001 Oct 01, 1986

0.147MG/GM

N012104 001

0.147MG/GM

A205782 001 Apr 13, 2015

0.055MG/SPRAY

A078104 001 Jul 30, 2009

TRIAMCINOLONE HEXACETONIDE

INJECTABLE;INJECTION

ARISTOSPAN

+ SANDOZ

+

5MG/ML

20MG/ML

N016466 001

N016466 002

TRIAMTERENE

CAPSULE;ORAL

DYRENIUM

CONCORDIA PHARMS INC

+

50MG

100MG

N013174 001

N013174 002

0.125MG

0.25MG

N017892 003 Apr 26, 1985

N017892 001 Nov 15, 1982

0.125MG

0.25MG

0.125MG

0.25MG

A074031
A074031
A074224
A074224

250MG

N019194 001 Nov 08, 1985

TRIAZOLAM

TABLET;ORAL

HALCION

AB
PHARMACIA AND UPJOHN

AB
+

TRIAZOLAM

AB
MYLAN PHARMS INC

AB

AB
ROXANE

AB

TRIENTINE HYDROCHLORIDE

CAPSULE;ORAL

SYPRINE

+ ATON

TRIFLUOPERAZINE HYDROCHLORIDE

TABLET;ORAL

TRIFLUOPERAZINE HYDROCHLORIDE

AB
MYLAN
EQ
AB
EQ
AB
EQ
AB
+
EQ
AB
SANDOZ
EQ
AB
EQ
AB
EQ
AB
EQ
TRIFLURIDINE

SOLUTION/DROPS;OPHTHALMIC

TRIFLURIDINE

AT
ALCON PHARMS LTD

VIROPTIC

AT
+ MONARCH PHARMS

1MG BASE

2MG BASE

5MG BASE

10MG BASE

1MG BASE

2MG BASE

5MG BASE

10MG BASE

A040209
A040209
A040209
A040209
A085785
A085786
A085789
A085788

001
002
001
002

001
002
003
004
001

001

001

001

Mar
Mar
Jun
Jun

Jul
Jul
Jul
Jul

25,
25,
01,
01,

07,
07,
07,
07,

1994

1994

1994

1994

1997

1997

1997

1997

1%

A074311 001 Oct 06, 1995

1%

N018299 001

TRIHEXYPHENIDYL HYDROCHLORIDE

ELIXIR;ORAL

TRIHEXYPHENIDYL HYDROCHLORIDE

AA
MIKART
2MG/5ML

AA
+ PHARM ASSOC
2MG/5ML

TABLET;ORAL

TRIHEXYPHENIDYL HYDROCHLORIDE

AA
NATCO PHARMA LTD
2MG

AA
5MG

AA
VINTAGE PHARMS
2MG

AA
5MG

AA
+ WATSON LABS
2MG

AA
+
5MG

A040251 001 Sep 27, 1999

A040177 001 Apr 17, 1997

A091630
A091630
A040254
A040254
A084363
A084364

001
002
001
002
001

001

Nov
Nov
Dec
Dec

17,
17,
24,
24,

2010

2010

1998

1998

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST

TRIMETHADIONE

TABLET;ORAL

TRIDIONE

+ ABBVIE

150MG

3-373(of 388)

N005856 009

TRIMETHOBENZAMIDE HYDROCHLORIDE

CAPSULE;ORAL

TIGAN

AB
+ KING PHARMS
300MG
TRIMETHOBENZAMIDE HYDROCHLORIDE

AB
GAVIS PHARMS
300MG
AB
MUTUAL PHARMA
300MG
INJECTABLE;INJECTION

TIGAN

AP
+ PAR STERILE PRODUCTS
100MG/ML
TRIMETHOBENZAMIDE HYDROCHLORIDE

AP
LUITPOLD
100MG/ML
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE

AP
LUITPOLD
100MG/ML

A091329 001 Mar 08, 2011

TRIMETHOPRIM

TABLET;ORAL

TRIMETHOPRIM

AB
NOVEL LABS INC
AB
+ TEVA
AB
WATSON LABS

100MG
100MG
100MG

A091437 001 Jun 15, 2011

N018679 001 Jul 30, 1982

A070049 001 Jun 06, 1985

TRIMETHOPRIM HYDROCHLORIDE

SOLUTION;ORAL

PRIMSOL

+ FSC

EQ 50MG BASE/5ML

N074973 001 Jan 24, 2000

N017531 006 Dec 13, 2001

A076546 001 Aug 20, 2003

A076570 001 Aug 28, 2003

N017530 001

A091330 001 Mar 08, 2011

TRIMIPRAMINE MALEATE

CAPSULE;ORAL

SURMONTIL

AB
ODYSSEY PHARMS
AB
+
AB
TRIMIPRAMINE MALEATE

AB
MIKAH PHARMA
AB
AB

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

N016792 001

N016792 002

N016792 003 Sep 15, 1982

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

A077361 001 Aug 02, 2006

A077361 002 Aug 02, 2006

A077361 003 Aug 02, 2006

TRIPTORELIN PAMOATE

INJECTABLE;INTRAMUSCULAR

TRELSTAR

+ ACTAVIS LABS UT INC
+
+

EQ 3.75MG BASE/VIAL
EQ 11.25MG BASE/VIAL
EQ 22.5MG BASE/VIAL

N020715 001 Jun 15, 2000

N021288 001 Jun 29, 2001

N022437 001 Mar 10, 2010

TROMETHAMINE

INJECTABLE;INJECTION

THAM

+ HOSPIRA

3.6GM/100ML

N013025 002

0.5%
1%

A084305 001

A084306 001

0.5%
1%

A040314 001 Sep 29, 2000

A040315 001 Sep 29, 2000

0.5%
1%

A040067 001 Jul 27, 1994

A040064 001 Jul 27, 1994

TROSPIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

TROSPIUM CHLORIDE

AB
ACTAVIS LABS FL INC
60MG
AB
PADDOCK LLC
60MG
AB
SANDOZ INC
60MG
TABLET;ORAL

TROSPIUM CHLORIDE

AB
APOTEX
20MG

A091289 001 Oct 12, 2012

A201291 001 May 24, 2013

A091635 001 Apr 29, 2015

TROPICAMIDE

SOLUTION/DROPS;OPHTHALMIC

MYDRIACYL

AT
+ ALCON
AT
+
TROPICACYL

AT
AKORN
AT
TROPICAMIDE

AT
BAUSCH AND LOMB
AT

A091513 001 Dec 06, 2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-374(of 388)

PRESCRIPTION DRUG PRODUCT LIST

TROSPIUM CHLORIDE

TABLET;ORAL

TROSPIUM CHLORIDE

AB
GLENMARK GENERICS
AB
PADDOCK LLC
TRYPAN BLUE

SOLUTION;OPHTHALMIC

MEMBRANEBLUE

+ DORC
VISIONBLUE

+ DORC

20MG
20MG

A091575 001 Aug 13, 2010

A091573 001 Nov 17, 2010

0.15%

N022278 001 Feb 20, 2009

0.06%

N021670 001 Dec 16, 2004

ULIPRISTAL ACETATE

TABLET;ORAL

ELLA

+ LAB HRA PHARMA

30MG

N022474 001 Aug 13, 2010

UMECLIDINIUM BROMIDE

POWDER;INHALATION

INCRUSE ELLIPTA

+ GLAXO GRP ENGLAND

EQ 62.5MCG BASE/INH

N205382 001 Apr 30, 2014

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

POWDER;INHALATION

ANORO ELLIPTA

+ GLAXOSMITHKLINE
EQ 0.0625MG BASE/INH;EQ 0.025MG
BASE/INH

UNOPROSTONE ISOPROPYL

SOLUTION/DROPS;OPHTHALMIC

RESCULA

+ R-TECH UENO LTD

N203975 001 Dec 18, 2013

0.15%

N021214 001 Aug 03, 2000

1uCi

N020617 001 May 09, 1997

1uCi

N020617 002 May 09, 1997

10GM/PACKET

N208159 001 Dec 11, 2015

2GM/PACKET

N208169 001 Sep 04, 2015

UROFOLLITROPIN

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

BRAVELLE

+ FERRING
75 IU/VIAL

N021289 001 May 06, 2002

UREA, C-14

CAPSULE;ORAL

PYTEST

+ AVENT
PYTEST KIT

+ AVENT
URIDINE TRIACETATE

GRANULE;ORAL

VISTOGARD

+ WELLSTAT THERAP
XURIDEN

+ WELLSTAT THERAP

URSODIOL

CAPSULE;ORAL

ACTIGALL

AB
+ ACTAVIS LABS UT INC
URSODIOL

AB
COREPHARMA
AB
EPIC PHARMA
AB
LANNETT
AB
MYLAN
AB
TEVA PHARMS
TABLET;ORAL

URSO 250

AB
FOREST LABS INC
URSO FORTE

AB
+ FOREST LABS INC
URSODIOL

AB
GLENMARK GENERICS
AB
AB
IMPAX LABS INC
AB
AB
PAR PHARM
AB

300MG

N019594 002 Dec 31, 1987

300MG
300MG
300MG
300MG
300MG

A077895
A075517
A079082
A090530
A075592

250MG

N020675 001 Dec 10, 1997

500MG

N020675 002 Jul 21, 2004

250MG
500MG
250MG
500MG
250MG
500MG

A090801
A090801
A200826
A200826
A202540
A202540

001
001
001
001
001

001
002
001
002
001
002

Jul
Mar
Dec
Feb
May

Jul
Jul
Dec
Dec
Feb
Feb

27,
14,
15,
17,
25,

12,
12,
23,
23,
14,
14,

2006

2000

2008

2010

2000

2011

2011

2011

2011

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-375(of 388)

PRESCRIPTION DRUG PRODUCT LIST

VALACYCLOVIR HYDROCHLORIDE

TABLET;ORAL

VALACYCLOVIR HYDROCHLORIDE
AB
APOTEX INC
AB
AB
AUROBINDO PHARMA
AB
AB
CIPLA LTD
AB
AB
DR REDDYS LABS LTD
AB
AB
HETERO LABS LTD V
AB
AB
JUBILANT GENERICS
AB
AB
MYLAN
AB
AB
MYLAN PHARMS INC
AB
AB
ROXANE
AB
AB
SANDOZ
AB
AB
SUN PHARM INDS LTD
AB
AB
TEVA PHARMS
AB
AB
WATSON LABS INC
AB
AB
WOCKHARDT
AB
VALTREX
AB
GLAXOSMITHKLINE
AB
+

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

500MG BASE

1GM BASE

EQ 500MG BASE

EQ 1GM BASE

VALGANCICLOVIR HYDROCHLORIDE

FOR SOLUTION;ORAL

VALCYTE

+ HOFFMANN LA ROCHE

50MG/ML

TABLET;ORAL

VALCYTE

AB
+ HOFFMANN LA ROCHE

EQ 450MG BASE

VALGANCICLOVIR HYDROCHLORIDE

AB
DR REDDYS LABS LTD

EQ 450MG BASE

AB
ENDO PHARMS INC

EQ 450MG BASE

VALPROATE SODIUM

INJECTABLE;INJECTION

DEPACON
AP
+ ABBVIE
VALPROATE SODIUM
AP
BEDFORD
AP
FRESENIUS KABI USA
AP
HIKMA FARMACEUTICA
VALPROIC ACID

CAPSULE;ORAL

DEPAKENE

AB
+ ABBVIE

VALPROIC ACID

AB
BANNER LIFE SCIENCES

AB
CATALENT

AB
SUN PHARM INDS LTD

SYRUP;ORAL

DEPAKENE

AA
+ ABBVIE

VALPROIC ACID

AA
ALPHARMA

AA
ANI PHARMS INC

AA
HIGH TECH PHARMA

AA
PHARM ASSOC

AA
SUN PHARM INDS INC

AA
VINTAGE

AA
WOCKHARDT

A090500
A090500
A090682
A090682
A077135
A077135
A079012
A079012
A203047
A203047
A201506
A201506
A078070
A078070
A078518
A078518
A078656
A078656
A077478
A077478
A076588
A076588
A077655
A077655
A090370
A090370
A090216
A090216

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Apr
Apr
May
May
May
May
May
May
Apr
Apr
Apr
Apr
May
May
May
May
May
May
May
May
Jan
Jan
May
May
Mar
Mar
May
May

04,
04,
24,
24,
24,
24,
24,
24,
08,
08,
03,
03,
24,
24,
24,
24,
24,
24,
24,
24,
31,
31,
24,
24,
16,
16,
24,
24,

2014

2014

2010

2010

2010

2010

2010

2010

2015

2015

2012

2012

2010

2010

2010

2010

2010

2010

2010

2010

2007

2007

2010

2010

2011

2011

2010

2010

N020487 001 Jun 23, 1995

N020487 002 Jun 23, 1995

N022257 001 Aug 28, 2009

N021304 001 Mar 29, 2001

A203511 001 Nov 04, 2014

A200790 001 Nov 04, 2014

EQ 100MG BASE/ML

N020593 001 Dec 30, 1996

EQ 100MG BASE/ML

EQ 100MG BASE/ML

EQ 100MG BASE/ML

A076295 001 Nov 14, 2002

A076539 001 Jun 26, 2003

A078523 001 Feb 17, 2010

250MG

N018081 001

250MG

250MG

250MG

A073484 001 Jun 29, 1993

A073229 001 Oct 29, 1991

A091037 001 Feb 22, 2013

250MG/5ML

N018082 001

250MG/5ML

250MG/5ML

250MG/5ML

250MG/5ML

250MG/5ML

250MG/5ML

250MG/5ML

A075782
A073178
A074060
A075379
A090517
A077960
A070868

001
001
001
001
001
001
001

Dec
Aug
Jan
Dec
May
Oct
Jul

22,
25,
13,
15,
28,
13,
01,

2000

1992

1995

2000

2010

2006

1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-376(of 388)

PRESCRIPTION DRUG PRODUCT LIST

VALRUBICIN

SOLUTION;INTRAVESICAL

VALSTAR PRESERVATIVE FREE

+ ENDO PHARM

VALSARTAN

TABLET;ORAL

DIOVAN
AB
NOVARTIS
AB
AB
AB
+
VALSARTAN
AB
ALEMBIC PHARMS LTD
AB
AB
AB
AB
AMNEAL PHARMS
AB
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
AB
HETERO LABS LTD V
AB
AB
AB
AB
IVAX PHARMS
AB
AB
AB
AB
JUBILANT GENERICS
AB
AB
AB
AB
LUPIN LTD
AB
AB
AB
AB
MYLAN LABS LTD
AB
AB
AB
AB
OHM LABS INC
AB
AB
AB
AB
PRINSTON INC
AB
AB
AB
AB
TORRENT PHARMS LTD
AB
AB
AB
AB
WATSON LABS INC
AB
AB
AB
VANCOMYCIN HYDROCHLORIDE

CAPSULE;ORAL

VANCOCIN HYDROCHLORIDE

AB
ANI PHARMS INC

AB
+

VANCOMYCIN HYDROCHLORIDE

AB
AKORN

AB

AB
FRESENIUS KABI USA

AB

AB
LUPIN LTD

40MG/ML

N020892 001 Sep 25, 1998

40MG

80MG

160MG

320MG

N021283
N021283
N021283
N021283

004
001
002
003

Aug
Jul
Jul
Jul

14,
18,
18,
18,

2002

2001

2001

2001

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

40MG

80MG

160MG

320MG

A091367
A091367
A091367
A091367
A204011
A204011
A204011
A204011
A202223
A202223
A202223
A202223
A203311
A203311
A203311
A203311
A077530
A077530
A077530
A077530
A203536
A203536
A203536
A203536
A201677
A201677
A201677
A201677
A090866
A090866
A090866
A090866
A077492
A077492
A077492
A077492
A204821
A204821
A204821
A204821
A202728
A202728
A202728
A202728
A090642
A090642
A090642
A090642

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

05,
05,
05,
05,
11,
11,
11,
11,
05,
05,
05,
05,
05,
05,
05,
05,
04,
04,
04,
04,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
26,
26,
26,
26,
09,
09,
09,
09,
05,
05,
05,
05,
05,
05,
05,
05,

2015

2015

2015

2015

2016

2016

2016

2016

2015

2015

2015

2015

2015

2015

2015

2015

2016

2016

2016

2016

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2014

2014

2014

2014

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

EQ 125MG BASE

EQ 250MG BASE

N050606 001 Apr 15, 1986

N050606 002 Apr 15, 1986

EQ
EQ
EQ
EQ
EQ

A065478
A065478
A065453
A065453
A090439

125MG
250MG
125MG
250MG
125MG

BASE

BASE

BASE

BASE

BASE

001
002
001
002
001

Apr
Apr
Jun
Jun
Jan

09,
09,
18,
18,
28,

2012

2012

2012

2012

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-377(of 388)

PRESCRIPTION DRUG PRODUCT LIST

VANCOMYCIN HYDROCHLORIDE

CAPSULE;ORAL

VANCOMYCIN HYDROCHLORIDE

AB
EQ 250MG BASE
AB
STRIDES PHARMA
EQ 125MG BASE
AB
EQ 250MG BASE
AB
WATSON LABS
EQ 125MG BASE
AB
EQ 250MG BASE
INJECTABLE;INJECTION

VANCOMYCIN HYDROCHLORIDE

AP
CUSTOPHARM INC
EQ 5GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EMCURE PHARMS LTD
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
EQ 5GM BASE/VIAL
AP
+ FRESENIUS KABI USA
EQ 500MG BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
AP
+
EQ 5GM BASE/VIAL
AP
+
EQ 10GM BASE/VIAL
AP
+ HOSPIRA
EQ 500MG BASE/VIAL
AP
+
EQ 500MG BASE/VIAL
AP
+
EQ 750MG BASE/VIAL
AP
+
EQ 750MG BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
AP
+
EQ 1GM BASE/VIAL
AP
+
EQ 5GM BASE/VIAL
AP
HOSPIRA INC
EQ 10GM BASE/VIAL
AP
MUSTAFA NEVZAT ILAC
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
MYLAN LABS LTD
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 5GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
SAGENT PHARMS
EQ 5GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
SANDOZ
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
SANDOZ INC
EQ 5GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
TEVA PHARMS USA
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 5GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP
XELLIA PHARMS APS
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 5GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER

+ BAXTER HLTHCARE
EQ 500MG BASE/100ML
+
EQ 750MG BASE/150ML
POWDER;IV (INFUSION)

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

SAMSON MEDCL
EQ 100GM BASE

A091532 001 Jan 06, 2016

VANDETANIB

TABLET;ORAL

CAPRELSA

IPR PHARMS INC
+

100MG
300MG

N022405 001 Apr 06, 2011

N022405 002 Apr 06, 2011

2.5MG
5MG
10MG
20MG

N021400
N021400
N021400
N021400

2.5MG

A091347 001 May 03, 2012

VARDENAFIL HYDROCHLORIDE

TABLET;ORAL

LEVITRA

AB
BAYER HLTHCARE
AB
AB
AB
+
VARDENAFIL HYDROCHLORIDE

AB
TEVA PHARMS

A090439
A065490
A065490
A065510
A065510

002
001
002
001
002

Jan
Apr
Apr
Apr
Apr

28,
09,
09,
09,
09,

2015

2012

2012

2012

2012

A204125
A204125
A204107
A204107
A202275
A202275
A202464
A202274
A062663
A062663
A062663
A062663
A062911
A062931
A062912
A062933
A062912
A062933
A063076
A065455
A065401
A065401
A065397
A065397
A065432
A091469
A091554
A200837
A200837
A090250
A090250
A201048
A201048
A201251
A201251
A201250
A201250
A091377
A091377
A206243
A206243

001
002
001
002
001
002
001
001
001
002
003
004
001
001
002
002
001
001
001
001
001
002
001
002
001
001
001
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Dec
Dec
Dec
Dec
Oct
Oct
Oct
Oct
Mar
Jul
Jun
Nov
Aug
Oct
Jan
May
Aug
Oct
Dec
Apr
Jun
Jun
Dec
Dec
Dec
Jul
Sep
Aug
Sep
Apr
Apr
Aug
Aug
Dec
Dec
Dec
Dec
Sep
Sep
Dec
Dec

28,
28,
28,
28,
31,
31,
09,
31,
17,
31,
03,
28,
04,
29,
07,
27,
04,
29,
21,
29,
30,
30,
30,
30,
30,
01,
19,
10,
02,
27,
27,
10,
10,
23,
23,
23,
23,
09,
09,
23,
23,

2015

2015

2015

2015

2013

2013

2013

2013

1987

1987

1988

1997

1988

1992

2009

2009

1988

1992

1990

2009

2008

2008

2008

2008

2008

2011

2011

2012

2014

2010

2010

2012

2012

2015

2015

2015

2015

2015

2015

2015

2015

N050671 001 Apr 29, 1993

N050671 002 Dec 20, 2010

003
001
002
004

Aug
Aug
Aug
Aug

19,
19,
19,
19,

2003

2003

2003

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-378(of 388)

PRESCRIPTION DRUG PRODUCT LIST

VARDENAFIL HYDROCHLORIDE

TABLET;ORAL
VARDENAFIL HYDROCHLORIDE
AB
5MG
AB
10MG
AB
20MG
TABLET, ORALLY DISINTEGRATING;ORAL

STAXYN

AB
+ BAYER HLTHCARE

10MG

VARDENAFIL HYDROCHLORIDE

AB
WATSON LABS INC

10MG

A091347 002 May 03, 2012

A091347 003 May 03, 2012

A091347 004 May 03, 2012

N200179 001 Jun 17, 2010

A203689 001 Apr 22, 2015

VARENICLINE TARTRATE

TABLET;ORAL

CHANTIX

PFIZER INC

+

EQ 0.5MG BASE

EQ 1MG BASE

N021928 001 May 10, 2006

N021928 002 May 10, 2006

VASOPRESSIN

SOLUTION;IV (INFUSION)

VASOSTRICT

+ PAR STERILE PRODUCTS

20UNITS/ML (20UNITS/ML)

N204485 001 Apr 17, 2014

VECURONIUM BROMIDE

INJECTABLE;INJECTION

VECURONIUM BROMIDE

AP
BEDFORD
AP
AP
HOSPIRA
AP
AP
MUSTAFA NEVZAT
AP
AP
MYLAN LABS LTD
AP
AP
+ SUN PHARMA GLOBAL
AP
+
AP
TEVA PHARMS USA
AP

10MG/VIAL

20MG/VIAL

10MG/VIAL

20MG/VIAL

10MG/VIAL

20MG/VIAL

10MG/VIAL

20MG/VIAL

10MG/VIAL

20MG/VIAL

10MG/VIAL

20MG/VIAL

A075549
A075549
A075164
A075164
A078274
A078274
A090243
A090243
A079001
A079001
A074688
A074688

VELAGLUCERASE ALFA

INJECTABLE;IV (INFUSION)

VPRIV

SHIRE HUMAN GENETIC

400 UNITS/VIAL

N022575 001 Feb 26, 2010

VEMURAFENIB

TABLET;ORAL

ZELBORAF

+ HOFFMANN LA ROCHE

240MG

N202429 001 Aug 17, 2011

VENLAFAXINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

EFFEXOR XR

AB
WYETH PHARMS INC

EQ
AB

EQ
AB
+

EQ
VENLAFAXINE HYDROCHLORIDE

AB
ANCHEN PHARMS

EQ
AB

EQ
AB

EQ
AB
AUROBINDO PHARMA LTD
EQ
AB

EQ
AB

EQ
AB
DR REDDYS LABS LTD

EQ
AB

EQ
AB

EQ
AB
MYLAN

EQ
AB

EQ
AB

EQ
AB
ORCHID HLTHCARE

EQ
AB

EQ
AB

EQ
AB
TEVA

EQ
AB

EQ
AB

EQ
AB
TORRENT PHARMS LLC

EQ

001
002
001
002
001
002
001
002
001
002
001
002

Jun
Jun
Oct
Oct
Dec
Dec
May
May
Jun
Jun
Aug
Aug

13,
13,
21,
21,
29,
29,
11,
11,
17,
17,
25,
25,

2000

2000

1999

1999

2008

2008

2010

2010

2009

2009

1999

1999

37.5MG BASE

75MG BASE

150MG BASE

N020699 001 Oct 20, 1997

N020699 002 Oct 20, 1997

N020699 004 Oct 20, 1997

37.5MG BASE

75MG BASE

150MG BASE

37.5MG BASE

75MG BASE

150MG BASE

37.5MG BASE

75MG BASE

150MG BASE

37.5MG BASE

75MG BASE

150MG BASE

37.5MG BASE

75MG BASE

150MG BASE

37.5MG BASE

75MG BASE

150MG BASE

37.5MG BASE

A078087
A078087
A078087
A200834
A200834
A200834
A078421
A078421
A078421
A078789
A078789
A078789
A091123
A091123
A091123
A076565
A076565
A076565
A090899

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001

Mar
Mar
Mar
Apr
Apr
Apr
May
May
May
Jun
Jun
Jun
Jul
Jul
Jul
Jun
Jun
Jun
Jun

16,
16,
16,
14,
14,
14,
06,
06,
06,
01,
01,
01,
11,
11,
11,
28,
28,
28,
01,

2012

2012

2012

2011

2011

2011

2011

2011

2011

2011

2011

2011

2011

2011

2011

2010

2010

2010

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-379(of 388)

PRESCRIPTION DRUG PRODUCT LIST

VENLAFAXINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

VENLAFAXINE HYDROCHLORIDE

AB
EQ
AB
EQ
AB
VALEANT PHARMS NORTH
EQ
AB
EQ
AB
EQ
AB
WOCKHARDT
EQ
AB
EQ
AB
EQ
AB
ZYDUS PHARMS USA INC
EQ
AB
EQ
AB
EQ
TABLET;ORAL

VENLAFAXINE HYDROCHLORIDE

AB
ALEMBIC PHARMS LTD
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
AMNEAL PHARMS
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
AUROBINDO PHARMA
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
DR REDDYS LABS LTD
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
HERITAGE PHARMS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
MYLAN
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
SUN PHARM INDS INC
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
TEVA
EQ
AB
EQ
AB
+
EQ
AB
EQ
AB
EQ
AB
VINTAGE
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
YAOPHARMA CO LTD
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
ZYDUS PHARMS USA
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ

75MG BASE
150MG BASE
37.5MG BASE
75MG BASE
150MG BASE
37.5MG BASE
75MG BASE
150MG BASE
37.5MG BASE
75MG BASE
150MG BASE

A090899
A090899
A090071
A090071
A090071
A078865
A078865
A078865
A090174
A090174
A090174

002
003
001
002
003
001
002
003
001
002
003

Jun
Jun
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

01,
01,
15,
15,
15,
14,
14,
14,
14,
14,
14,

2011

2011

2011

2011

2011

2011

2011

2011

2011

2011

2011

25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE

A078932
A078932
A078932
A078932
A078932
A079098
A079098
A079098
A079098
A079098
A090555
A090555
A090555
A090555
A090555
A078301
A078301
A078301
A078301
A078301
A078554
A078554
A078554
A078554
A078554
A077166
A077166
A077166
A077166
A077166
A078627
A078627
A078627
A078627
A078627
A076690
A076690
A076690
A076690
A076690
A090027
A090027
A090027
A090027
A090027
A202036
A202036
A202036
A202036
A202036
A077653
A077653
A077653
A077653
A077653

001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005

Dec
Dec
Dec
Dec
Dec
May
May
May
May
May
Apr
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Jan
Jan
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
May
May
May
Jun
Jun
Jun
Jun
Jun

14,
14,
14,
14,
14,
11,
11,
11,
11,
11,
07,
07,
07,
07,
07,
13,
13,
13,
13,
13,
09,
09,
09,
09,
09,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
03,
03,
03,
03,
03,
04,
04,
04,
04,
04,
28,
28,
28,
28,
28,
13,
13,
13,
13,
13,

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2010

2008

2008

2008

2008

2008

2009

2009

2009

2009

2009

2008

2008

2008

2008

2008

2008

2008

2008

2008

2008

2006

2006

2006

2006

2006

2010

2010

2010

2010

2010

2015

2015

2015

2015

2015

2008

2008

2008

2008

2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-380(of 388)

PRESCRIPTION DRUG PRODUCT LIST

VENLAFAXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

VENLAFAXINE HYDROCHLORIDE

AB
OSMOTICA PHARM
EQ
AB
EQ
AB
+
EQ
AB
SUN PHARMA GLOBAL
EQ
AB
EQ
AB
EQ
OSMOTICA PHARM
EQ

37.5MG BASE
75MG BASE
150MG BASE
37.5MG BASE
75MG BASE
150MG BASE
225MG BASE

VERAPAMIL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

VERAPAMIL HYDROCHLORIDE

AB
MYLAN
100MG
AB
120MG
AB
180MG
AB
200MG
AB
240MG
AB
300MG
VERELAN

AB
RECRO GAINESVILLE
120MG
AB
180MG
AB
240MG
VERELAN PM

AB
RECRO GAINESVILLE
100MG
AB
200MG
AB
+
300MG
VERELAN

+ RECRO GAINESVILLE
360MG
SOLUTION;INTRAVENOUS

VERAPAMIL HYDROCHLORIDE

AP
+ HOSPIRA
10MG/4ML (2.5MG/ML)
AP
+
5MG/2ML (2.5MG/ML)
AP
+
5MG/2ML (2.5MG/ML)
AP
+
10MG/4ML (2.5MG/ML)
TABLET;ORAL

CALAN

AB
GD SEARLE LLC
40MG
AB
80MG
AB
+
120MG
VERAPAMIL HYDROCHLORIDE

AB
HERITAGE PHARMS INC
40MG
AB
80MG
AB
120MG
AB
MYLAN
80MG
AB
120MG
AB
WATSON LABS
40MG
AB
80MG
AB
120MG
TABLET, EXTENDED RELEASE;ORAL

CALAN SR

AB
+ PFIZER
120MG
AB
+
180MG
AB
+
240MG
VERAPAMIL HYDROCHLORIDE

AB
APOTEX CORP
120MG
AB
180MG
AB
240MG
120MG
AB
GLENMARK GENERICS
AB
180MG
AB
240MG
AB
IVAX SUB TEVA PHARMS
120MG
AB
180MG
AB
240MG
AB
MYLAN
120MG
AB
180MG
AB
240MG
AB
PAR PHARM
120MG
AB
240MG
AB
SUN PHARM INDS INC
120MG
AB
180MG
AB
240MG

N022104
N022104
N022104
A091272
A091272
A091272
N022104

001
002
003
001
002
003
004

May
May
May
Aug
Aug
Aug
May

20,
20,
20,
18,
18,
18,
20,

2008

2008

2008

2010

2010

2010

2008

A078306
A075138
A075138
A078306
A075138
A078306

001
001
002
002
003
003

Aug
Apr
Apr
Aug
Apr
Aug

09,
20,
20,
09,
20,
09,

2007

1999

1999

2007

1999

2007

N019614 001 May 29, 1990

N019614 003 Jan 09, 1992

N019614 002 May 29, 1990

N020943 001 Nov 25, 1998

N020943 002 Nov 25, 1998

N020943 003 Nov 25, 1998

N019614 004 May 10, 1996

A070738
A075136
A070737
A070737

001
001
001
002

May
Oct
May
May

06,
20,
06,
06,

1987

1998

1987

1987

N018817 003 Feb 23, 1988

N018817 001 Sep 10, 1984

N018817 002 Sep 10, 1984

A071881
A071880
A071881
A071483
A071483
A072924
A070995
A070994

002
001
001
002
001
001
001
001

Oct
Apr
Apr
Feb
Feb
Jun
Oct
Oct

14,
05,
05,
15,
15,
29,
01,
01,

2015

1988

1988

1989

1989

1993

1986

1986

N019152 003 Mar 06, 1991

N019152 002 Dec 15, 1989

N019152 001 Dec 16, 1986

A200878
A200878
A200878
A090700
A090700
A078906
A073568
A074330
A073568
A074587
A074587
A074587
A075072
A075072
A090529
A090529
A090529

001
002
003
001
002
001
002
001
001
002
003
001
001
003
001
002
003

Apr
Apr
Apr
Aug
Aug
Sep
Oct
Jan
Jul
Feb
Sep
Mar
May
May
Dec
Dec
Dec

20,
20,
20,
03,
03,
17,
10,
31,
31,
21,
09,
23,
25,
25,
30,
30,
30,

2012

2012

2012

2011

2011

2009

1997

1994

1992

1997

1997

1996

1999

1999

2011

2011

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-381(of 388)

PRESCRIPTION DRUG PRODUCT LIST

VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

COVERA-HS

BC
+ GD SEARLE LLC
180MG
BC
+
240MG

N020552 001 Feb 26, 1996

N020552 002 Feb 26, 1996

VERTEPORFIN

INJECTABLE;INJECTION

VISUDYNE

+ VALEANT LUXEMBOURG

15MG/VIAL

N021119 001 Apr 12, 2000

500MG/PACKET

N022006 001 Aug 21, 2009

500MG

N020427 001 Aug 21, 2009

10MG
20MG
40MG

N022567 001 Jan 21, 2011

N022567 002 Jan 21, 2011

N022567 003 Jan 21, 2011

10MG/VIAL
1MG/ML

A089395 001 Apr 09, 1987

A089515 001 Apr 29, 1987

VIGABATRIN

FOR SOLUTION;ORAL

SABRIL

+ LUNDBECK LLC
TABLET;ORAL

SABRIL

+ LUNDBECK LLC
VILAZODONE HYDROCHLORIDE

TABLET;ORAL

VIIBRYD

+ FOREST LABS LLC

VINBLASTINE SULFATE

INJECTABLE;INJECTION

VINBLASTINE SULFATE

+ EUROHLTH INTL SARL
+ FRESENIUS KABI USA

VINCRISTINE SULFATE

INJECTABLE;INJECTION

VINCRISTINE SULFATE PFS

AP
+ HOSPIRA
1MG/ML
AP
TEVA PHARMS USA
1MG/ML
INJECTABLE, LIPOSOMAL;INTRAVENOUS

MARQIBO KIT

+ TALON THERAP
5MG/5ML (1MG/ML)

A071484 001 Apr 19, 1988

A075493 001 Sep 01, 1999

N202497 001 Aug 09, 2012

VINORELBINE TARTRATE

INJECTABLE;INJECTION

NAVELBINE

AP
+ PIERRE FABRE
VINORELBINE TARTRATE

AP
ACTAVIS TOTOWA
AP
BEDFORD
AP
DR REDDYS LABS LTD
AP
EUROHLTH INTL SARL
AP
FRESENIUS KABI USA
AP
HOSPIRA
AP
JIANGSU HANSOH PHARM
AP
MYLAN LABS LTD
AP
TEVA PHARMS USA

EQ 10MG BASE/ML

N020388 001 Dec 23, 1994

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A078011
A076461
A202017
A075992
A076849
A076827
A091106
A200148
A076028

VISMODEGIB

CAPSULE;ORAL

ERIVEDGE

+ GENENTECH

150MG

N203388 001 Jan 30, 2012

VITAMIN A PALMITATE

INJECTABLE;INJECTION

AQUASOL A

+ HOSPIRA

EQ 50,000 UNITS BASE/ML

N006823 001

VORAPAXAR SULFATE

TABLET;ORAL

ZONTIVITY

+ MERCK SHARP DOHME

EQ 2.08MG BASE

N204886 001 May 08, 2014

10MG
10MG
10MG
10MG
10MG
10MG
10MG
10MG
10MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

001
001
001
001
001
001
001
001
001

Jul
Dec
Sep
Jun
Apr
Jun
Sep
Aug
Feb

22,
11,
12,
10,
18,
02,
26,
31,
03,

2009

2003

2013

2003

2005

2005

2012

2012

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-382(of 388)

PRESCRIPTION DRUG PRODUCT LIST

VORICONAZOLE

FOR SUSPENSION;ORAL

VFEND

AB
+ PF PRISM CV

VORICONAZOLE

AB
MYLAN PHARMS INC

INJECTABLE;IV (INFUSION)

VFEND

AP
+ PF PRISM CV

VORICONAZOLE

AP
SANDOZ INC

TABLET;ORAL

VFEND

AB
PF PRISM CV

AB
+

VORICONAZOLE

AB
GLENMARK PHARMS LTD

AB

AB
MYLAN PHARMS INC

AB

AB
SANDOZ INC

AB

AB
TEVA PHARMS

AB

VORINOSTAT

CAPSULE;ORAL

ZOLINZA

+ MERCK

VORTIOXETINE HYDROBROMIDE

TABLET;ORAL

BRINTELLIX

TAKEDA PHARMS USA

+

WARFARIN SODIUM

TABLET;ORAL

COUMADIN

AB
BRISTOL MYERS SQUIBB

AB

AB

AB

AB

AB

AB

AB

AB
+

JANTOVEN

AB
USL PHARMA

AB

AB

AB

AB

AB

AB

AB

AB

WARFARIN SODIUM

AB
AMNEAL PHARMS

AB

AB

AB

AB

AB

AB

AB

AB

AB
BARR

AB

AB

AB

200MG/5ML

N021630 001 Dec 19, 2003

200MG/5ML

A202361 001 May 28, 2013

200MG/VIAL

N021267 001 May 24, 2002

200MG/VIAL

A090862 001 May 30, 2012

50MG

200MG

N021266 001 May 24, 2002

N021266 002 May 24, 2002

50MG

200MG

50MG

200MG

50MG

200MG

50MG

200MG

A203503
A203503
A090547
A090547
A200265
A200265
A091658
A091658

100MG

N021991 001 Oct 06, 2006

EQ
EQ
EQ
EQ

N204447
N204447
N204447
N204447

001
002
003
004

Sep
Sep
Sep
Sep

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

N009218
N009218
N009218
N009218
N009218
N009218
N009218
N009218
N009218

022
013

018

025
023
007

026
016

005

Mar 01, 1990

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

A040416
A040416
A040416
A040416
A040416
A040416
A040416
A040416
A040416

001
002
003
004
005
006
007
008
009

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

02,
02,
02,
02,
02,
02,
02,
02,
02,

2003

2003

2003

2003

2003

2003

2003

2003

2003

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

1MG

2MG

2.5MG

3MG

A202202
A202202
A202202
A202202
A202202
A202202
A202202
A202202
A202202
A040145
A040145
A040145
A040145

001
002
003
004
005
006
007
008
009
001
002
003
008

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Nov

04,
04,
04,
04,
04,
04,
04,
04,
04,
26,
26,
26,
05,

2013

2013

2013

2013

2013

2013

2013

2013

2013

1997

1997

1997

1998

5MG BASE

10MG BASE

15MG BASE

20MG BASE

001
002
001
002
001
002
001
002

Sep
Sep
Apr
Apr
Dec
Dec
Apr
Apr

02,
02,
22,
22,
12,
12,
06,
06,

30,
30,
30,
30,

2015

2015

2010

2010

2011

2011

2012

2012

2013

2013

2013

2013

Nov 18, 1996

Aug 24, 1993

Nov 18, 1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-383(of 388)

PRESCRIPTION DRUG PRODUCT LIST

WARFARIN SODIUM

TABLET;ORAL

WARFARIN SODIUM
AB
AB
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
AB
AB
AB
AB
AB
AB
IPCA LABS LTD
AB
AB
AB
AB
AB
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
AB
AB
AB
PLIVA
AB
AB
AB
AB
AB
AB
AB
AB
AB
TARO
AB
AB
AB
AB
AB
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
AB
AB
AB
AB
AB
XENON XE-133

GAS;INHALATION

XENON XE 133

AA
LANTHEUS MEDCL

4MG

5MG

6MG

7.5MG

10MG

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

A040145
A040145
A040145
A040145
A040145
A090935
A090935
A090935
A090935
A090935
A090935
A090935
A090935
A090935
A200104
A200104
A200104
A200104
A200104
A200104
A200104
A200104
A200104
A040415
A040415
A040415
A040415
A040415
A040415
A040415
A040415
A040415
A040616
A040616
A040616
A040616
A040616
A040616
A040616
A040616
A040616
A040301
A040301
A040301
A040301
A040301
A040301
A040301
A040301
A040301
A040663
A040663
A040663
A040663
A040663
A040663
A040663
A040663
A040663

004
005
009
006
007
001
002
003
004
005
006
007
008
009
001
002
003
004
005
006
007
008
009
001
002
003
004
005
006
007
008
009
009
001
002
003
004
005
006
007
008
002
003
004
005
006
007
008
009
001
001
002
003
004
005
006
007
008
009

20mCi/VIAL

10mCi/VIAL

N017284 002

N017284 001

Mar
Mar
Nov
Mar
Mar
May
May
May
May
May
May
May
May
May
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
May
May
May
May
May
May
May
May
May

26,
26,
05,
26,
26,
25,
25,
25,
25,
25,
25,
25,
25,
25,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
29,
27,
27,
27,
27,
27,
27,
05,
05,
05,
05,
05,
05,
05,
05,
05,
15,
15,
15,
15,
15,
15,
15,
15,
15,
30,
30,
30,
30,
30,
30,
30,
30,
30,

1997

1997

1998

1997

1997

2011

2011

2011

2011

2011

2011

2011

2011

2011

2013

2013

2013

2013

2013

2013

2013

2013

2013

2004

2004

2004

2004

2004

2004

2004

2004

2004

2006

2006

2006

2006

2006

2006

2006

2006

2006

1999

1999

1999

1999

1999

1999

1999

1999

1999

2006

2006

2006

2006

2006

2006

2006

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-384(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ZAFIRLUKAST

TABLET;ORAL

ACCOLATE

AB
PAR PHARM INC
AB
+
ZAFIRLUKAST

AB
DR REDDYS LABS LTD
AB

10MG
20MG

N020547 003 Sep 17, 1999

N020547 001 Sep 26, 1996

10MG
20MG

A090372 001 Nov 18, 2010

A090372 002 Nov 18, 2010

ZALEPLON

CAPSULE;ORAL

SONATA

AB
PFIZER
AB
+
ZALEPLON

AB
AUROBINDO PHARMA
AB
AB
CIPLA LTD
AB
AB
HIKMA PHARMS LLC
AB
AB
MYLAN
AB
AB
ORCHID HLTHCARE
AB
AB
ROXANE
AB
AB
TEVA PHARMS
AB
AB
UNICHEM
AB
AB
UPSHER SMITH
AB

5MG
10MG

N020859 001 Aug 13, 1999

N020859 002 Aug 13, 1999

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A078829
A078829
A077505
A077505
A078147
A078147
A077238
A077238
A090374
A090374
A077237
A077237
A077239
A077239
A078989
A078989
A078706
A078706

ZANAMIVIR

POWDER;INHALATION

RELENZA

+ GLAXOSMITHKLINE

5MG

N021036 001 Jul 26, 1999

ZICONOTIDE ACETATE

INJECTABLE;INTRATHECAL

PRIALT

+ JAZZ PHARMS INTL
+
+

100MCG/1ML (100MCG/ML)
500MCG/20ML (25MCG/ML)
500MCG/5ML (100MCG/ML)

N021060 002 Dec 28, 2004

N021060 001 Dec 28, 2004

N021060 004 Dec 28, 2004

100MG

N019655 001 Mar 19, 1987

100MG
100MG

A078128 001 Mar 27, 2006

A078349 001 May 23, 2007

10MG/ML

N019951 001 Feb 02, 1990

10MG/ML

A091457 001 May 06, 2010

50MG/5ML

N019910 001 Sep 28, 1989

50MG/5ML
50MG/5ML

A077268 001 Sep 19, 2005

A077981 001 Jun 26, 2008

300MG
300MG
300MG
300MG
300MG
300MG

A077267
A090561
A090092
A078922
A076844
A202058

ZIDOVUDINE

CAPSULE;ORAL

RETROVIR

AB
+ VIIV HLTHCARE
ZIDOVUDINE

AB
AUROBINDO PHARMA LTD
AB
CIPLA LTD
INJECTABLE;INJECTION

RETROVIR

AP
+ VIIV HLTHCARE
ZIDOVUDINE

AP
LUITPOLD
SYRUP;ORAL

RETROVIR

AA
+ VIIV HLTHCARE
ZIDOVUDINE

AA
AUROBINDO
AA
CIPLA LTD
TABLET;ORAL

ZIDOVUDINE

AB
AUROBINDO
AB
CIPLA
AB
+ HETERO LABS LTD III
AB
MYLAN PHARMS INC
AB
ROXANE
AB
SUNSHINE LAKE

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

001
001
001
001
001
001

Jun
Jun
Jun
Jun
Nov
Nov
Jun
Jun
Sep
Sep
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

Sep
Oct
Apr
Feb
Sep
Oct

06,
06,
20,
20,
25,
25,
06,
06,
17,
17,
06,
06,
06,
06,
06,
06,
06,
06,

19,
27,
25,
14,
19,
07,

2008

2008

2008

2008

2008

2008

2008

2008

2009

2009

2008

2008

2008

2008

2008

2008

2008

2008

2005

2010

2008

2008

2005

2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-385(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ZILEUTON

TABLET;ORAL

ZYFLO

+ CHIESI USA INC
600MG
TABLET, EXTENDED RELEASE;ORAL

ZYFLO CR

+ CHIESI USA INC
600MG

N022052 001 May 30, 2007

ZINC ACETATE

CAPSULE;ORAL

GALZIN

TEVA
+

N020458 001 Jan 28, 1997

N020458 002 Jan 28, 1997

N020471 003 Dec 09, 1996

EQ 25MG ZINC
EQ 50MG ZINC

ZINC CHLORIDE

INJECTABLE;INJECTION

ZINC CHLORIDE IN PLASTIC CONTAINER

+ HOSPIRA
EQ 1MG ZINC/ML

N018959 001 Jun 26, 1986

ZIPRASIDONE HYDROCHLORIDE

CAPSULE;ORAL

GEODON

AB
+ PFIZER
AB
AB
AB
ZIPRASIDONE HYDROCHLORIDE

AB
APOTEX CORP
AB
AB
AB
AB
DR REDDYS LABS INC
AB
AB
AB
AB
LUPIN PHARMS
AB
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
AB
SANDOZ INC
AB
AB
AB
AB
WOCKHARDT LTD
AB
AB
AB

EQ
EQ
EQ
EQ

20MG
40MG
60MG
80MG

BASE
BASE
BASE
BASE

N020825
N020825
N020825
N020825

001
002
003
004

Feb
Feb
Feb
Feb

05,
05,
05,
05,

2001

2001

2001

2001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

20MG
40MG
60MG
80MG
20MG
40MG
60MG
80MG
20MG
40MG
60MG
80MG
20MG
40MG
60MG
80MG
20MG
40MG
60MG
80MG
20MG
40MG
60MG
80MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A077561
A077561
A077561
A077561
A077565
A077565
A077565
A077565
A077560
A077560
A077560
A077560
A202395
A202395
A202395
A202395
A077562
A077562
A077562
A077562
A090348
A090348
A090348
A090348

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep

02,
02,
02,
02,
02,
02,
02,
02,
02,
02,
02,
02,
10,
10,
10,
10,
01,
01,
01,
01,
05,
05,
05,
05,

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2012

2013

2013

2013

2013

2012

2012

2012

2012

2012

2012

2012

2012

ZIPRASIDONE MESYLATE

INJECTABLE;INTRAMUSCULAR

GEODON

+ PFIZER

EQ 20MG BASE/ML

N020919 001 Jun 21, 2002

EQ 5MG BASE/100ML

N021817 001 Apr 16, 2007

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

N203231
A202828
A202472
A200918
A202548
A204367
A091186
A091363
A201783
A201801
A091516
A202930
A202182

ZOLEDRONIC ACID

INJECTABLE;IV (INFUSION)

RECLAST

AP
+ NOVARTIS
ZOLEDRONIC ACID

AP
ACS DOBFAR INFO SA
AP
AP
ACTAVIS INC
AP
AKORN
AP
AKORN INC
AP
APOTEX INC
AP
DR REDDYS LABS LTD
AP
AP
EMCURE PHARMS LTD
AP
AP
FRESENIUS KABI USA
AP
GLAND PHARMA LTD
AP
HIKMA FARMACEUTICA

4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
4MG
4MG

BASE/100ML
BASE/100ML
BASE/5ML
BASE/100ML
BASE/5ML
BASE/100ML
BASE/5ML
BASE/100ML
BASE/5ML
BASE/100ML
BASE/5ML
BASE/5ML
BASE/5ML

001
001
001
001
001
001
001
001
001
001
001
001
001

Aug
Sep
Mar
Aug
May
Dec
Mar
Mar
Mar
Mar
Apr
Aug
Jun

02,
23,
04,
21,
22,
24,
04,
29,
12,
29,
23,
05,
03,

2013

2013

2013

2014

2014

2015

2013

2013

2013

2013

2015

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-386(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ZOLEDRONIC ACID

INJECTABLE;IV (INFUSION)

ZOLEDRONIC ACID

AP
HOSPIRA INC
AP
AP
MYLAN LABS LTD
AP
PHARMACEUTICS
AP
AP
PHARMS
AP
SAGENT PHARMS
AP
+ SUN PHARMA GLOBAL
AP
AP
USV NORTH AMERICA
ZOMETA

AP
+ NOVARTIS
AP
+
SOLUTION;IV (INFUSION)

ZOLEDRONIC ACID

HOSPIRA INC

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

4MG
5MG
4MG
4MG
5MG
4MG
4MG
4MG
4MG
4MG

BASE/5ML
BASE/100ML
BASE/5ML
BASE/5ML
BASE/100ML
BASE/5ML
BASE/5ML
BASE/VIAL
BASE/5ML
BASE/5ML

001
001
001
001
001
001
001
001
001
001

Mar
Apr
Mar
Mar
Aug
May
Nov
Mar
Mar
Sep

19,
05,
04,
04,
05,
07,
24,
04,
04,
04,

2015

2013

2013

2013

2013

2013

2014

2013

2013

2014

EQ 4MG BASE/5ML
EQ 4MG BASE/100ML

N021223 002 Mar 07, 2003

N021223 003 Jun 17, 2011

EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML)

N204016 001 Dec 28, 2015

ZOLMITRIPTAN

SPRAY;NASAL

ZOMIG

ASTRAZENECA
2.5MG/SPRAY
+
5MG/SPRAY
TABLET;ORAL

ZOLMITRIPTAN

AB
ALEMBIC PHARMS LTD
2.5MG
AB
5MG
AB
APOTEX INC
2.5MG
AB
5MG
AB
GLENMARK GENERICS
2.5MG
AB
5MG
AB
INVAGEN PHARMS
2.5MG
AB
5MG
AB
JUBILANT GENERICS
2.5MG
AB
5MG
AB
MACLEODS PHARMS LTD
2.5MG
AB
5MG
AB
MYLAN PHARMS INC
2.5MG
AB
5MG
AB
SUN PHARMA GLOBAL
2.5MG
AB
5MG
AB
TEVA PHARMS USA
2.5MG
AB
5MG
ZOMIG

AB
IPR
2.5MG
AB
+
5MG
TABLET, ORALLY DISINTEGRATING;ORAL

ZOLMITRIPTAN

AB
APOTEX INC
2.5MG
AB
5MG
AB
GLENMARK GENERICS
2.5MG
AB
5MG
AB
JUBILANT GENERICS
2.5MG
AB
5MG
AB
MACLEODS PHARMS LTD
2.5MG
AB
5MG
AB
ZYDUS PHARMS USA INC
2.5MG
AB
5MG
ZOMIG-ZMT

AB
ASTRAZENECA
2.5MG
AB
+
5MG
ZOLPIDEM TARTRATE

SPRAY, METERED;ORAL

ZOLPIMIST

+ AMHERST PHARMS LLC
TABLET;ORAL

AMBIEN

AB
SANOFI AVENTIS US
AB
+

A090621
A202837
A202650
A091170
A202163
A202571
A091493
A090018
A202746
A202923

N021450 003 Sep 16, 2013

N021450 004 Sep 30, 2003

A204232
A204232
A202078
A202078
A201779
A201779
A204284
A204284
A202279
A202279
A203772
A203772
A203186
A203186
A203476
A203476
A090861
A090861

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Sep
Sep
May
May
May
May
Apr
Apr
Nov
Nov
Sep
Sep
May
May
Nov
Nov
Mar
Mar

30,
30,
14,
14,
14,
14,
09,
09,
20,
20,
30,
30,
14,
14,
13,
13,
04,
04,

2015

2015

2013

2013

2013

2013

2014

2014

2014

2014

2015

2015

2013

2013

2014

2014

2014

2014

N020768 001 Nov 25, 1997

N020768 002 Nov 25, 1997

A202476
A202476
A202560
A202560
A202956
A202956
A204336
A204336
A202890
A202890

001
002
001
002
001
002
001
002
001
002

May
May
May
May
Sep
Sep
Oct
Oct
May
May

14,
14,
14,
14,
17,
17,
22,
22,
15,
15,

2013

2013

2013

2013

2015

2015

2015

2015

2013

2013

N021231 001 Feb 13, 2001

N021231 002 Sep 17, 2001

5MG/SPRAY

N022196 001 Dec 19, 2008

5MG
10MG

N019908 001 Dec 16, 1992

N019908 002 Dec 16, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-387(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ZOLPIDEM TARTRATE

TABLET;ORAL

ZOLPIDEM TARTRATE
AB
APOTEX INC
5MG

AB
10MG

AB
AUROBINDO PHARMA
5MG

AB
10MG

AB
CARLSBAD
5MG

AB
10MG

AB
CIPLA LTD
5MG

AB
10MG

AB
INVAGEN PHARMS
5MG

AB
10MG

AB
LEK PHARMS DD
5MG

AB
10MG

AB
MYLAN
5MG

AB
10MG

AB
ROXANE
5MG

AB
10MG

AB
SUN PHARM INDS INC

5MG

AB

10MG

AB
SUN PHARM INDS LTD

5MG

AB

10MG

AB
TEVA

5MG

AB

10MG

AB
TORRENT PHARMS

5MG

AB

10MG

AB
VINTAGE

5MG

AB

10MG

AB
WOCKHARDT

5MG

AB

10MG

TABLET;SUBLINGUAL

INTERMEZZO

AB
PURDUE PHARMA

1.75MG

AB
+

3.5MG

ZOLPIDEM TARTRATE

AB
NOVEL LABS INC

1.75MG

AB

3.5MG

EDLUAR

MEDA PHARMS

5MG

+

10MG

TABLET, EXTENDED RELEASE;ORAL

AMBIEN CR

AB
SANOFI AVENTIS US

6.25MG

AB
+

12.5MG

ZOLPIDEM TARTRATE

AB
ACTAVIS ELIZABETH

6.25MG

AB

12.5MG

AB
ACTAVIS LABS FL INC

6.25MG

AB

12.5MG

AB
ANCHEN PHARMS

6.25MG

AB

12.5MG

AB
APOTEX INC

6.25MG

AB

12.5MG

AB
LUPIN LTD

6.25MG

AB

12.5MG

AB
SANDOZ

6.25MG

AB

12.5MG

AB
SYNTHON PHARMS

6.25MG

AB

12.5MG

ZONISAMIDE

CAPSULE;ORAL

ZONEGRAN

AB
EISAI INC

AB

AB
+

ZONISAMIDE

AB
APOTEX INC

AB

AB

AB
BANNER LIFE SCIENCES

AB

A077884
A077884
A078413
A078413
A077990
A077990
A077388
A077388
A078184
A078184
A077322
A077322
A076578
A076578
A077214
A077214
A077359
A077359
A078055
A078055
A076410
A076410
A077903
A077903
A078616
A078616
A078426
A078426

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Apr
Apr
May
May
Apr
Apr
Jul
Jul
Sep
Sep
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Aug
Aug
Nov
Nov
May
May

23,
23,
04,
04,
23,
23,
30,
30,
07,
07,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
17,
17,
21,
21,
15,
15,

2007

2007

2007

2007

2007

2007

2012

2012

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2008

2008

2007

2007

N022328 001 Nov 23, 2011

N022328 002 Nov 23, 2011

A204299 001 Jun 03, 2015

A204299 002 Jun 03, 2015

N021997 001 Mar 13, 2009

N021997 002 Mar 13, 2009

N021774 002 Sep 02, 2005

N021774 001 Sep 02, 2005

A078179
A078179
A090153
A090153
A078148
A078148
A200266
A200266
A078970
A078970
A090107
A090107
A078483
A078483

002
001
001
002
002
001
001
002
001
002
001
002
001
002

Oct
Jun
Mar
Mar
Apr
Dec
Sep
Sep
Sep
Sep
Jul
Jul
Apr
Jun

13,
06,
25,
25,
14,
03,
10,
10,
11,
11,
01,
01,
12,
06,

2010

2011

2013

2013

2011

2010

2013

2013

2013

2013

2011

2011

2011

2011

25MG

50MG

100MG

N020789 003 Aug 22, 2003

N020789 002 Aug 22, 2003

N020789 001 Mar 27, 2000

25MG

50MG

100MG

25MG

50MG

A077642
A077642
A077642
A077813
A077813

001
002
003
001
002

Dec
Dec
Dec
Aug
Aug

22,
22,
22,
16,
16,

2005

2005

2005

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

3-388(of 388)

PRESCRIPTION DRUG PRODUCT LIST

ZONISAMIDE

CAPSULE;ORAL

ZONISAMIDE
AB
AB
GLENMARK GENERICS
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
MYLAN PHARMS INC
AB
AB
AB
SUN PHARM INDS (IN)
AB
AB
AB
WOCKHARDT
AB
AB
AB
ZYDUS PHARMS USA
AB
AB

100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A077813
A077651
A077651
A077651
A077869
A077869
A077869
A077637
A077637
A077637
A077647
A077647
A077647
A077634
A077634
A077634
A077636
A077636
A077636
A077625
A077625
A077625

003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
003
002
001
001
002
003

Aug
Jan
Jan
Jan
May
May
May
Dec
Dec
Dec
Dec
Dec
Dec
Mar
Mar
Mar
Jul
Jul
Dec
Oct
Oct
Oct

16,
30,
30,
30,
31,
31,
31,
22,
22,
22,
22,
22,
22,
17,
17,
17,
27,
27,
22,
16,
16,
16,

2006

2006

2006

2006

2006

2006

2006

2005

2005

2005

2005

2005

2005

2006

2006

2006

2006

2006

2005

2006

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-1(of 18)

OTC DRUG PRODUCT LIST

ACETAMINOPHEN

SUPPOSITORY;RECTAL

ACEPHEN

G AND W LABS

ACETAMINOPHEN

PERRIGO NEW YORK

TARO PHARMS NORTH

120MG

325MG

325MG

650MG

650MG

N018060
A072344
N018060
A072237
N018060

001

001 Mar 27, 1992

003 Dec 18, 1986

001 Mar 27, 1992

002

120MG

650MG

120MG

325MG

650MG

A070607
A070608
N018337
N018337
N018337

001 Apr 06, 1987

001 Dec 01, 1986

003 Sep 12, 1983

002

001

+

INFANTS' FEVERALL

TARO PHARMS NORTH

80MG

NEOPAP

POLYMEDICA

120MG

TABLET, EXTENDED RELEASE;ORAL

ACETAMINOPHEN

OHM LABS

650MG

PERRIGO

650MG

SUN PHARM INDS LTD

650MG

TYLENOL

+ J AND J CONSUMER INC
650MG

+

650MG

ACETAMINOPHEN; ASPIRIN; CAFFEINE

TABLET;ORAL

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

PERRIGO
250MG;250MG;65MG

EXCEDRIN (MIGRAINE)

+ NOVARTIS
250MG;250MG;65MG

ALCOHOL; CHLORHEXIDINE GLUCONATE

SOLUTION;TOPICAL

AVAGARD

+ 3M
61%;1%

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

TABLET, CHEWABLE;ORAL

FOAMCOAT

GUARDIAN DRUG
80MG;20MG

GAVISCON

SANOFI AVENTIS US
80MG;20MG

+
160MG;40MG

ASPIRIN

CAPSULE;ORAL

ASPIRIN

+ PLX PHARMA

325MG

AVOBENZONE; ECAMSULE; OCTOCRYLENE

CREAM;TOPICAL

ANTHELIOS SX

+ LOREAL USA
2%;2%;10%

CAPITAL SOLEIL 15

+ LOREAL USA
2%;3%;10%

AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE

CREAM;TOPICAL

ANTHELIOS 20

+ LOREAL USA
2%;2%;10%;2%

ANTHELIOS 40

+ LOREAL USA
2%;3%;10%;5%

+
2%;3%;10%;5%

AVOBENZONE; OCTINOXATE; OXYBENZONE

LOTION;TOPICAL

SHADE UVAGUARD

+ BAYER HEALTHCARE LLC
3%;7.5%;3%

N018337 004 Aug 26, 1992

N016401 001

A076200 001 Mar 19, 2002

A075077 001 Feb 25, 2000

A078569 001 Dec 14, 2011

N019872 001 Jun 08, 1994

N019872 002 Jan 11, 2001

A075794 001 Nov 26, 2001

N020802 001 Jan 14, 1998

N021074 001 Jun 07, 2001

A071793 001 Sep 04, 1987

N018685 001 Dec 09, 1983

N018685 002 Dec 09, 1983

N203697 001 Jan 14, 2013

N021502 001 Jul 21, 2006

N021501 001 Oct 02, 2006

N021471 001 Oct 05, 2006

N022009 001 Mar 31, 2008

N022009 002 Oct 29, 2009

N020045 001 Dec 07, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-2(of 18)

OTC DRUG PRODUCT LIST

BENTOQUATAM
LOTION;TOPICAL
IVY BLOCK
+ STAND HOMEOPATH

5%

N020532 001 Aug 26, 1996

BUDESONIDE
SPRAY, METERED;NASAL
RHINOCORT ALLERGY
+ ASTRAZENECA PHARMS

0.032MG/SPRAY

N020746 003 Mar 23, 2015

BUTENAFINE HYDROCHLORIDE
CREAM;TOPICAL
LOTRIMIN ULTRA
+ BAYER HEALTHCARE LLC

1%

N021307 001 Dec 07, 2001

BUTOCONAZOLE NITRATE
CREAM;VAGINAL
FEMSTAT 3
+ BAYER

2%

N020421 001 Dec 21, 1995

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

TABLET, CHEWABLE;ORAL

CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE

PERRIGO R AND D
800MG;10MG;165MG
PEPCID COMPLETE

+ J AND J CONSUMER INC
800MG;10MG;165MG
CETIRIZINE HYDROCHLORIDE

CAPSULE;ORAL

CETIRIZINE HYDROCHLORIDE ALLERGY

BANNER LIFE SCIENCES
5MG
+
10MG
CETIRIZINE HYDROCHLORIDE HIVES RELIEF

BANNER LIFE SCIENCES
5MG
+
10MG
SYRUP;ORAL

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

AMNEAL PHARMS
5MG/5ML
AUROBINDO PHARMA
5MG/5ML
BIO PHARM INC
5MG/5ML
CYPRESS PHARM
5MG/5ML
PERRIGO R AND D
5MG/5ML
5MG/5ML
SILARX
5MG/5ML
SUN PHARM INDS INC
5MG/5ML
TARO
5MG/5ML
5MG/5ML
TRIS PHARMA INC
5MG/5ML
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF

AMNEAL PHARMS
5MG/5ML
AUROBINDO PHARMA
5MG/5ML
BIO PHARM INC
5MG/5ML
CYPRESS PHARM
5MG/5ML
PERRIGO R AND D
5MG/5ML
SILARX
5MG/5ML
SUN PHARM INDS INC
5MG/5ML
TARO
5MG/5ML
5MG/5ML
TRIS PHARMA INC
5MG/5ML
CHILDREN'S ZYRTEC ALLERGY

+ J AND J CONSUMER INC
5MG/5ML
CHILDREN'S ZYRTEC HIVES RELIEF

+ J AND J CONSUMER INC
5MG/5ML
TABLET;ORAL

CETIRIZINE HYDROCHLORIDE ALLERGY

AMNEAL PHARMS NY
5MG
10MG
APOTEX INC
5MG
10MG
AUROBINDO PHARMA LTD
5MG
10MG
CADISTA PHARMS
5MG
10MG
CIPLA LTD
5MG
10MG

A077355 001 Feb 06, 2008

N020958 001 Oct 16, 2000

N022429 001 Jul 23, 2009

N022429 004 Jul 23, 2009

N022429 003 Jul 23, 2009

N022429 002 Jul 23, 2009

A090765
A090750
A090474
A090300
A204226
A090254
A091130
A091327
A090182
A201546
A090572

002
002
002
001
001
002
001
001
002
001
001

Oct
Feb
Mar
Oct
Sep
Apr
Apr
Oct
Apr
May
Nov

07,
02,
30,
10,
09,
09,
22,
17,
22,
20,
16,

2009

2010

2009

2008

2013

2008

2011

2011

2008

2011

2012

A090765
A090750
A090474
A090300
A090254
A091130
A091327
A090182
A201546
A090572

001
001
001
002
001
002
002
001
002
002

Oct
Feb
Mar
Oct
Apr
Apr
Oct
Apr
May
Nov

07,
02,
30,
10,
09,
22,
17,
22,
20,
16,

2009

2010

2009

2008

2008

2011

2011

2008

2011

2012

N022155 002 Nov 16, 2007

N022155 001 Nov 16, 2007

A078780
A078780
A078317
A078317
A090760
A090760
A078933
A078933
A077318
A077318

001
004
001
002
001
003
001
002
001
002

Jan
Jan
Dec
Dec
Aug
Aug
Jun
Jun
Jul
Jul

21,
21,
27,
27,
05,
05,
15,
15,
25,
25,

2010

2010

2007

2007

2015

2015

2010

2010

2013

2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-3(of 18)

OTC DRUG PRODUCT LIST

CETIRIZINE HYDROCHLORIDE

TABLET;ORAL

CETIRIZINE HYDROCHLORIDE ALLERGY

CONTRACT PHARMACAL
5MG

10MG

DR REDDYS LABS LTD
5MG

10MG

IPCA LABS LTD
5MG

10MG

MYLAN
5MG

10MG

ORCHID HLTHCARE
5MG

10MG

PERRIGO R AND D
5MG

10MG

SANDOZ
5MG

10MG

SUN PHARM INDS INC
5MG

10MG

SUN PHARM INDS LTD
5MG

10MG

TARO
5MG

5MG

TORRENT PHARMS LLC
5MG

10MG

UNICHEM
5MG

10MG

UNIQUE PHARM LABS
5MG

10MG

WOCKHARDT
5MG

10MG

CETIRIZINE HYDROCHLORIDE HIVES

CADISTA PHARMS
5MG

10MG

DR REDDYS LABS LTD
5MG

10MG

IPCA LABS LTD
5MG

10MG

MYLAN
5MG

10MG

ORCHID HLTHCARE
5MG

10MG

PERRIGO R AND D
5MG

10MG

SUN PHARM INDS INC
5MG

10MG

SUN PHARM INDS LTD
5MG

10MG

UNICHEM
5MG

10MG

UNIQUE PHARM LABS
5MG

10MG

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

AMNEAL PHARMS NY
5MG

10MG

AUROBINDO PHARMA LTD
5MG

10MG

TARO
10MG

10MG

TORRENT PHARMS LLC
5MG

10MG

ZYRTEC ALLERGY

J AND J CONSUMER INC
5MG

+
10MG

ZYRTEC HIVES RELIEF

J AND J CONSUMER INC
5MG

+
10MG

TABLET, CHEWABLE;ORAL

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

JUBILANT GENERICS
5MG

10MG

SANDOZ
5MG

A076047
A076047
A078343
A078343
A202277
A202277
A076677
A076677
A078862
A078862
A078336
A078336
A077946
A077946
A077499
A077499
A077498
A077498
A078072
A078072
A079191
A079191
A078680
A078680
A077829
A077829
A078427
A078427

001
002
004
003
002
004
001
002
001
002
001
002
001
002
001
002
001
002
001
003
001
004
003
004
001
004
003
004

Dec
Dec
Jan
Jan
Mar
Mar
Dec
Dec
Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jul
Jul
Apr
Apr
Jun
Jun
Aug
Aug
Dec
Dec

27,
27,
15,
15,
11,
11,
27,
27,
19,
19,
27,
27,
27,
27,
27,
27,
27,
27,
22,
22,
15,
15,
26,
26,
26,
26,
28,
28,

2007

2007

2008

2008

2014

2014

2007

2007

2009

2009

2007

2007

2007

2007

2007

2007

2007

2007

2009

2009

2010

2010

2009

2009

2009

2009

2007

2007

A078933
A078933
A078343
A078343
A202277
A202277
A076677
A076677
A078862
A078862
A078336
A078336
A077499
A077499
A077498
A077498
A078680
A078680
A077829
A077829

003
004
001
002
001
003
004
003
003
004
003
004
003
004
003
004
001
002
003
002

Jun
Jun
Jan
Jan
Mar
Mar
Dec
Dec
Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec
Jun
Jun
Aug
Aug

15,
15,
15,
15,
11,
11,
27,
27,
19,
19,
27,
27,
27,
27,
27,
27,
26,
26,
26,
26,

2010

2010

2008

2008

2014

2014

2007

2007

2009

2009

2007

2007

2007

2007

2007

2007

2009

2009

2009

2009

A078780
A078780
A090760
A090760
A078072
A078072
A079191
A079191

003
002
002
004
002
004
003
002

Jan
Jan
Aug
Aug
Jul
Jul
Apr
Apr

21,
21,
05,
05,
22,
22,
15,
15,

2010

2010

2015

2015

2009

2009

2010

2010

N019835 003 Nov 16, 2007

N019835 004 Nov 16, 2007

N019835 005 Nov 16, 2007

N019835 006 Nov 16, 2007

A091116 001 Feb 19, 2015

A091116 002 Feb 19, 2015

A078692 001 Feb 14, 2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-4(of 18)

OTC DRUG PRODUCT LIST

CETIRIZINE HYDROCHLORIDE

TABLET, CHEWABLE;ORAL

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

+
10MG
SUN PHARMA GLOBAL
5MG
10MG
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
JUBILANT GENERICS
5MG
10MG
SUN PHARMA GLOBAL
5MG
10MG
TABLET, ORALLY DISINTEGRATING;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
PAR PHARM INC
10MG
ZYRTEC ALLERGY
+ J AND J CONSUMER INC
10MG
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS
5MG;120MG
SANDOZ
5MG;120MG
SUN PHARM INDS LTD
5MG;120MG
ZYRTEC-D 12 HOUR
+ J AND J CONSUMER INC
5MG;120MG
CHLORHEXIDINE GLUCONATE
AEROSOL, METERED;TOPICAL
EXIDINE
+ XTTRIUM
CLOTH;TOPICAL
CHLORHEXIDINE GLUCONATE
+ SAGE PRODS
SOLUTION;TOPICAL
BRIAN CARE
SOAPCO
CHG SCRUB
ECOLAB
CIDA-STAT
ECOLAB
DYNA-HEX
BAJAJ MEDICAL LLC
EXIDINE
+ XTTRIUM
HIBICLENS
+ MOLNLYCKE HLTH
HIBISTAT
+ MOLNLYCKE HLTH
SPONGE;TOPICAL
BIOSCRUB
GRIFFEN
CHLORHEXIDINE GLUCONATE
BECTON DICKINSON
PHARMASEAL SCRUB CARE
+ CAREFUSION

A078692 002 Feb 14, 2008

A090142 001 Aug 30, 2011
A090142 002 Aug 30, 2011
A091116
A091116
A090142
A090142

003
004
003
004

Feb
Feb
Aug
Aug

19,
19,
30,
30,

2015
2015
2011
2011

A205490 001 Sep 02, 2015

N022578 001 Sep 03, 2010

A077170 001 Feb 25, 2008

A077991 001 Mar 05, 2008
A090922 001 Sep 28, 2012
N021150 002 Nov 09, 2007

4%

N019127 001 Dec 24, 1984

2%

N021669 001 Apr 25, 2005

4%

A071419 001 Dec 17, 1987

4%

N019258 002 Jul 22, 1986

2%

N019258 001 Jul 22, 1986

0.75%

N020111 001 Sep 11, 1997

2%
4%

N019422 001 Dec 17, 1985

N019125 001 Dec 24, 1984

4%

N017768 001

0.5%

N018300 001

4%

N019822 001 Mar 31, 1989

4%

A072525 001 Oct 24, 1989

4%

N019793 001 Dec 02, 1988

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

SPONGE;TOPICAL
CHLORAPREP ONE-STEP
+ CAREFUSION
2%;70% (3ML)
+
2%;70% (10.5ML)
+
2%;70% (26ML)
CHLORAPREP ONE-STEP FREPP
+ CAREFUSION
2%;70% (1.5ML)
CHLORAPREP WITH TINT
+ CAREFUSION
2%;70% (26ML)
+
2%;70% (10.5ML)
+
2%;70% (3ML)
SWAB;TOPICAL
CHLORAPREP ONE-STEP SEPP
+ CAREFUSION
2%;70% (0.67ML)

N020832 001 Jul 14, 2000

N020832 004 Aug 20, 2003
N020832 006 Nov 21, 2006
N020832 003 Apr 26, 2002
N020832 002 May 03, 2005
N020832 005 Apr 03, 2006
N020832 007 Oct 10, 2006

N021555 001 Oct 07, 2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-5(of 18)

OTC DRUG PRODUCT LIST

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

SWAB;TOPICAL

CHLORAPREP SINGLE SWABSTICK

+ CAREFUSION

2%;70% (1.75ML)

CHLORAPREP TRIPLE SWABSTICK

+ CAREFUSION

2%;70% (5.25ML)

PREVANTICS MAXI SWABSTICK

+ PROF DSPLS

3.15%;70% (5.1ML)

PREVANTICS SWAB

+ PROF DSPLS

3.15%;70% (1ML)

PREVANTICS SWABSTICK

+ PROF DSPLS

3.15%;70% (1.6ML)

CHLORPHENIRAMINE MALEATE

TABLET, EXTENDED RELEASE;ORAL

CHLOR-TRIMETON

+ BAYER HEALTHCARE LLC
12MG

CHLORPHENIRAMINE MALEATE

AVANTHI INC

12MG

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

TABLET;ORAL

ADVIL ALLERGY AND CONGESTION RELIEF

+ PFIZER
4MG;200MG;10MG

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

SUSPENSION;ORAL

CHILDREN'S ADVIL ALLERGY SINUS

+ PFIZER
1MG/5ML;100MG/5ML;15MG/5ML

TABLET;ORAL

ADVIL ALLERGY SINUS

+ PFIZER
2MG;200MG;30MG

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

CHLOR-TRIMETON

+ BAYER HEALTHCARE LLC
8MG;120MG

CIMETIDINE

TABLET;ORAL

CIMETIDINE

APOTEX

CONTRACT PHARMACAL

IVAX SUB TEVA PHARMS

PERRIGO

TAGAMET HB

+ MEDTECH PRODUCTS

CLEMASTINE FUMARATE

TABLET;ORAL

CLEMASTINE FUMARATE

PERRIGO

SANDOZ

TAVIST-1

+ NOVARTIS

N021555 002 May 10, 2005

N021555 003 Jun 10, 2009

N021524 003 Jun 03, 2005

N021524 001 Jun 03, 2005

N021524 002 Jun 03, 2005

N007638 002

A040829 001 May 13, 2009

N022113 001 Dec 21, 2011

N021587 001 Feb 24, 2004

N021441 001 Dec 19, 2002

N018397 001

100MG

200MG

200MG

200MG

200MG

200MG

A074948
A074948
A074961
A074963
A075345
A075285

200MG

N020238 002 Aug 21, 1996

1.34MG

1.34MG

A074512 001 Nov 22, 1995

A073458 001 Oct 31, 1993

1.34MG

N020925 001 Aug 21, 1992

CLOTRIMAZOLE

CREAM;VAGINAL

CLOTRIMAZOLE

ACTAVIS MID ATLANTIC
1%

TARO

1%

GYNE-LOTRIMIN

+ BAYER HEALTHCARE LLC
1%

GYNE-LOTRIMIN 3

+ BAYER HEALTHCARE LLC
2%

MYCELEX-7

BAYER HEALTHCARE LLC
1%

TRIVAGIZOLE 3

TARO

2%

CREAM, TABLET;TOPICAL, VAGINAL

GYNE-LOTRIMIN 3 COMBINATION PACK

+ BAYER HEALTHCARE LLC
200MG;200MG

001
002
001
001
001
001

Jun
Jul
Jun
Jun
Jun
Oct

19,
26,
19,
19,
16,
29,

1998

2002

1998

1998

1999

1998

A074165 001 Jul 16, 1993

A072641 001 Dec 04, 1995

N018052 002 Nov 30, 1990

N020574 001 Nov 24, 1998

N018230 002 Dec 26, 1991

N021143 001 Apr 12, 2000

N020526 002 Jul 29, 1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-6(of 18)

OTC DRUG PRODUCT LIST

CLOTRIMAZOLE

CREAM, TABLET;TOPICAL, VAGINAL

GYNE-LOTRIMIN COMBINATION PACK

+ BAYER HEALTHCARE LLC
100MG;100MG
MYCELEX-7 COMBINATION PACK
BAYER HEALTHCARE LLC
1%;100MG
TABLET;VAGINAL
GYNE-LOTRIMIN
+ BAYER HEALTHCARE LLC
100MG
GYNE-LOTRIMIN 3
+ BAYER HEALTHCARE LLC
200MG
MYCELEX-7
BAYER HEALTHCARE LLC
100MG

N018182 002 Dec 26, 1991

CROMOLYN SODIUM
SPRAY, METERED;NASAL
CROMOLYN SODIUM
+ BAUSCH AND LOMB
PERRIGO

A075702 001 Jul 03, 2001

A075427 001 Dec 12, 2001

5.2MG/SPRAY
5.2MG/SPRAY

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE

+ AVANTHI INC
6MG;120MG
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

ACTAVIS LABS FL INC
30MG;600MG
60MG;1.2GM
MUCINEX DM

RECKITT BENCKISER
30MG;600MG
+
60MG;1.2GM
DEXTROMETHORPHAN POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

DELSYM

+ RECKITT BENCKISER
EQ 30MG HBR/5ML
DEXTROMETHORPHAN POLISTIREX

TRIS PHARMA INC
EQ 30MG HBR/5ML
DIPHENHYDRAMINE CITRATE; IBUPROFEN

TABLET;ORAL

ADVIL PM

+ PFIZER
38MG;200MG
IBUPROFEN AND DIPHENHYDRAMINE CITRATE

DR REDDYS LABS LTD
38MG;200MG
PERRIGO R AND D
38MG;200MG
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

CAPSULE;ORAL

ADVIL PM

+ PFIZER
25MG;EQ 200MG FREE ACID AND POTASSIUM
SALT

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

BANNER LIFE SCIENCES
25MG;EQ 200MG FREE ACID AND POTASSIUM
SALT

STRIDES PHARMA
25MG;EQ 200MG FREE ACID AND POTASSIUM
SALT

N020289 002 Apr 26, 1993

N020389 002 Jun 23, 1994

N017717 002 Nov 30, 1990

N020525 001 Jul 29, 1996

A078648 001 Feb 27, 2013

A091070 001 Aug 31, 2015

A091070 002 Aug 31, 2015

N021620 002 Apr 29, 2004

N021620 001 Apr 29, 2004

N018658 001 Oct 08, 1982

A091135 001 May 25, 2012

N021394 001 Dec 21, 2005

A090619 001 Jul 08, 2009

A079113 001 Dec 22, 2008

N021393 001 Dec 21, 2005

A090397 001 Nov 22, 2010

A200888 001 Mar 05, 2012

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

TABLET;ORAL

ALEVE PM

+ BAYER HLTHCARE
25MG;220MG

N205352 001 Jan 17, 2014

DOCOSANOL

CREAM;TOPICAL

ABREVA

+ GLAXOSMITHKLINE

10%

N020941 001 Jul 25, 2000

25MG
25MG

A040564 001 Aug 27, 2004

A040167 001 Sep 18, 1996

25MG

N018066 001

DOXYLAMINE SUCCINATE

TABLET;ORAL

DOXYLAMINE SUCCINATE

LNK
PERRIGO
UNISOM

+ CHATTEM

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-7(of 18)

OTC DRUG PRODUCT LIST

ESOMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED RELEASE;ORAL

NEXIUM 24HR

EQ 20MG BASE

+ ASTRAZENECA LP

TABLET, DELAYED RELEASE;ORAL

NEXIUM 24HR

EQ 20MG BASE

+ ASTRAZENECA LP

FAMOTIDINE

TABLET;ORAL

FAMOTIDINE

DR REDDYS LABS LTD

IVAX SUB TEVA PHARMS

MYLAN

PERRIGO

SUN PHARM INDS LTD

TEVA

WOCKHARDT

PEPCID AC

J AND J CONSUMER INC

+

PEPCID AC

J AND J CONSUMER INC

TABLET, CHEWABLE;ORAL

FAMOTIDINE

PERRIGO

PEPCID AC

+ J AND J CONSUMER INC

N204655 001 Mar 28, 2014

N207920 01

Nov 23, 2015

10MG

20MG

10MG

10MG

10MG

20MG

10MG

20MG

10MG

10MG

20MG

A075758
A077367
A075512
A075674
A075400
A077351
A090283
A090283
A075312
A077146
A090837

Aug
Sep
Jul
Dec
Mar
Sep
Nov
Nov
May
Mar
Aug

10MG

20MG

N020325 001 Apr 28, 1995

N020325 002 Sep 23, 2003

10MG

N020902 001 Aug 05, 1999

10MG

A075715 001 Aug 22, 2003

20MG

N020801 002 Dec 17, 2007

FEXOFENADINE HYDROCHLORIDE

SUSPENSION;ORAL

CHILDREN'S ALLEGRA ALLERGY

30MG/5ML

+ SANOFI AVENTIS US

CHILDREN'S ALLEGRA HIVES

30MG/5ML

+ SANOFI AVENTIS US

CHILDREN'S FEXOFENADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC
30MG/5ML

CHILDREN'S FEXOFENADINE HYDROCHLORIDE

ACTAVIS MID ATLANTIC
30MG/5ML

TABLET;ORAL

ALLEGRA ALLERGY

60MG

SANOFI AVENTIS US

180MG

+

ALLEGRA HIVES

60MG

SANOFI AVENTIS US

180MG

+

CHILDREN'S ALLEGRA ALLERGY

SANOFI AVENTIS US
30MG

CHILDREN'S ALLEGRA HIVES

SANOFI AVENTIS US
30MG

CHILDREN'S FEXOFENADINE HYDROCHLORIDE
AUROLIFE PHARMA LLC
30MG

DR REDDYS LABS LTD
30MG

MYLAN
30MG

SUN PHARM INDS
30MG

TEVA
30MG

WOCKHARDT LTD
30MG

CHILDREN'S FEXOFENADINE HYDROCHLORIDE
DR REDDYS LABS LTD
30MG

MYLAN
30MG

SUN PHARM INDS
30MG

TEVA
30MG

WOCKHARDT LTD
30MG

FEXOFENADINE HYDROCHLORIDE ALLERGY

AUROLIFE PHARMA LLC
60MG

180MG

DR REDDYS LABS LTD
60MG

180MG

MYLAN
60MG

001
001
001
001
001
001
001
002
001
001
001

17,
25,
26,
21,
18,
25,
17,
17,
31,
07,
04,

2001

2006

2001

2001

2005

2006

2009

2009

2001

2005

2010

N201373 001 Jan 24, 2011

N201373 002 Jan 24, 2011

ALLERGY

A203330 001 Nov 18, 2014

HIVES

A203330 002 Nov 18, 2014

N020872 007 Jan 24, 2011

N020872 010 Jan 24, 2011

N020872 008 Jan 24, 2011

N020872 009 Jan 24, 2011

N020872 005 Jan 24, 2011

N020872 006 Jan 24, 2011

ALLERGY

A202039
A076502
A077081
A091567
A076447
A079112

001
004
004
002
004
002

Nov
Apr
Jul
Feb
Apr
Feb

19,
12,
21,
06,
13,
08,

2014

2011

2011

2012

2011

2012

A076502
A077081
A091567
A076447
A079112

005
005
001
005
001

Apr
Jul
Feb
Apr
Feb

12,
21,
06,
13,
08,

2011

2011

2012

2011

2012

A202039
A202039
A076502
A076502
A077081

002
003
006
008
006

Nov
Nov
Apr
Apr
Jul

19,
19,
12,
12,
21,

2014

2014

2011

2011

2011

HIVES

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-8(of 18)

OTC DRUG PRODUCT LIST

FEXOFENADINE HYDROCHLORIDE

TABLET;ORAL

FEXOFENADINE HYDROCHLORIDE ALLERGY

180MG
SCIEGEN PHARMS INC
60MG
180MG
SUN PHARM INDS
60MG
180MG
TEVA
60MG
180MG
WOCKHARDT LTD
60MG
180MG
FEXOFENADINE HYDROCHLORIDE HIVES

DR REDDYS LABS LTD
60MG

180MG

MYLAN
60MG

180MG

SCIEGEN PHARMS INC
60MG

180MG

SUN PHARM INDS
60MG

180MG

TEVA
60MG

180MG

WOCKHARDT LTD
60MG

180MG

TABLET, ORALLY DISINTEGRATING;ORAL

CHILDREN'S ALLEGRA ALLERGY

+ SANOFI AVENTIS US
30MG

CHILDREN'S ALLEGRA HIVES

+ SANOFI AVENTIS US
30MG

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

DR REDDYS LABS LTD
30MG

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES

DR REDDYS LABS LTD
30MG

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

+ SANOFI AVENTIS US
60MG;120MG

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

+ SANOFI AVENTIS US
180MG;240MG

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

DR REDDYS LABS LTD
60MG;120MG

180MG;240MG

SUN PHARMA GLOBAL
60MG;120MG

FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL

FLONASE ALLERGY RELIEF

+ GLAXOSMITHKLINE CONS

0.05MG/SPRAY

A077081
A204507
A204507
A091567
A091567
A076447
A076447
A079112
A079112

008
002
003
004
006
006
008
004
006

Jul
Sep
Sep
Feb
Feb
Apr
Apr
Feb
Feb

21,
16,
16,
06,
06,
13,
13,
08,
08,

2011

2015

2015

2012

2012

2011

2011

2012

2012

A076502
A076502
A077081
A077081
A204507
A204507
A091567
A091567
A076447
A076447
A079112
A079112

007
009
007
009
004
005
003
005
007
009
003
005

Apr
Apr
Jul
Jul
Sep
Sep
Feb
Feb
Apr
Apr
Feb
Feb

12,
12,
21,
21,
16,
16,
06,
06,
13,
13,
08,
08,

2011

2011

2011

2011

2015

2015

2012

2012

2011

2011

2012

2012

N021909 002 Jan 24, 2011

N021909 003 Jan 24, 2011

A202978 001 Jan 18, 2013

A202978 002 Jan 18, 2013

N020786 002 Jan 24, 2011

N021704 002 Jan 24, 2011

A076667 001 Nov 18, 2014

A079043 002 Jun 22, 2011

A090818 001 Jan 29, 2015

N205434 001 Jul 23, 2014

GUAIFENESIN

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN

ACTAVIS LABS FL INC
1.2GM

PERRIGO R AND D
600MG

MUCINEX

RECKITT BENCKISER
600MG

+
1.2GM

A091009 002 Sep 03, 2015

A078912 001 Nov 23, 2011

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

ACTAVIS LABS FL INC
600MG;60MG

1.2GM;120MG

MUCINEX D

RECKITT BENCKISER
600MG;60MG

+
1.2GM;120MG

A091071 001 May 27, 2015

A091071 002 May 27, 2015

N021282 001 Jul 12, 2002

N021282 002 Dec 18, 2002

N021585 001 Jun 22, 2004

N021585 002 Jun 22, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-9(of 18)

OTC DRUG PRODUCT LIST

IBUPROFEN

CAPSULE;ORAL

ADVIL LIQUI-GELS

+ PFIZER

ADVIL MIGRAINE LIQUI-GELS

+ PFIZER

IBUPROFEN

AMNEAL PHARMS

BANNER LIFE SCIENCES

+ CONTRACT PHARMACAL

MARKSANS PHARMA

P AND L DEV LLC

MIDOL LIQUID GELS

+ BANNER LIFE SCIENCES

SUSPENSION;ORAL

CHILDREN'S ADVIL

PFIZER

CHILDREN'S ADVIL-FLAVORED

PFIZER

CHILDREN'S ELIXSURE

MOBERG PHARMA NORTH

CHILDREN'S IBUPROFEN

PERRIGO

CHILDREN'S MOTRIN

+ J AND J CONSUMER INC

IBUPROFEN

ACTAVIS MID ATLANTIC

AMNEAL PHARMS

SUSPENSION/DROPS;ORAL

CHILDREN'S MOTRIN

+ J AND J CONSUMER INC

IBUPROFEN

PERRIGO

TRIS PHARMA INC

PEDIATRIC ADVIL

+ PFIZER

TABLET;ORAL

ADVIL

PFIZER

IBU-TAB 200

ALRA

IBUPROFEN

AMNEAL PHARMS

AMNEAL PHARMS NY

AVEMA PHARMA

CONTRACT PHARMACAL

DR REDDYS LA

DR REDDYS LABS INC

GRANULES INDIA

LNK

MARKSANS PHARMA

MCNEIL

MERRO PHARM

OHM

PAR PHARM

PERRIGO

PERRIGO R AND D

SVADS HOLDINGS SA

VINTAGE PHARMS

IBUPROHM

OHM LABS

EQ 200MG FREE ACID AND POTASSIUM SALT

N020402 001 Apr 20, 1995

EQ 200MG FREE ACID AND POTASSIUM SALT

N020402 002 Mar 16, 2000

EQ 200MG
EQ 200MG
200MG

EQ 200MG
EQ 200MG

A202300
A078682
A074782
A079205
A077338

FREE ACID AND POTASSIUM SALT

FREE ACID AND POTASSIUM SALT

FREE ACID AND POTASSIUM SALT

FREE ACID AND POTASSIUM SALT

001
001
001
001
001

Dec
Mar
Jul
Jun
Jul

23,
24,
06,
26,
10,

2011

2009

1998

2009

2009

200MG

N021472 001 Oct 18, 2002

100MG/5ML

N020589 001 Jun 27, 1996

100MG/5ML

N020589 002 Nov 07, 1997

100MG/5ML

N021604 001 Jan 07, 2004

100MG/5ML

A074937 001 Dec 22, 1998

100MG/5ML

N020516 001 Jun 16, 1995

100MG/5ML

100MG/5ML

A074916 001 Apr 30, 1999

A200457 001 Aug 18, 2011

40MG/ML

N020603 001 Jun 10, 1996

40MG/ML

40MG/ML

A075217 001 Dec 16, 1998

A079058 001 Aug 31, 2009

100MG/2.5ML

N020812 001 Jan 30, 1998

200MG

N018989 001 May 18, 1984

200MG

A071057 001 Aug 11, 1988

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

100MG

200MG

100MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

A079233
A071333
A072199
A076460
A071732
A071735
A072299
A074931
A075661
A076117
A079174
A076741
A075010
A075139
A091237
A091239
A073019
A070985
A071163
A070481
A072096
A075995
A077349
A079129
A091355
A071229
A071639

200MG

A071214 001 Dec 01, 1986

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Mar
Feb
May
Nov
Sep
Sep
Jul
Jul
Dec
Nov
Dec
Jun
Mar
Mar
Feb
Feb
Mar
Oct
Jul
Sep
Dec
Mar
Jun
Mar
Apr
Apr
Feb

18,
17,
23,
26,
10,
10,
01,
20,
12,
20,
10,
17,
01,
01,
08,
01,
30,
02,
15,
24,
08,
14,
21,
28,
04,
01,
02,

2014

1987

1988

2003

1987

1987

1988

1998

2001

2001

2010

2004

1999

1999

2011

2011

1994

1987

1986

1986

1987

2002

2005

2011

2011

1987

1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST

IBUPROFEN

TABLET;ORAL

JUNIOR STRENGTH ADVIL

PFIZER

JUNIOR STRENGTH IBUPROFEN

PERRIGO

JUNIOR STRENGTH MOTRIN

J AND J CONSUMER INC

MOTRIN IB

+ J AND J CONSUMER INC

PROFEN

CONTRACT PHARMACAL

TAB-PROFEN

PERRIGO

TABLET, CHEWABLE;ORAL

CHILDREN'S ADVIL

PFIZER

CHILDREN'S MOTRIN

J AND J CONSUMER INC

IBUPROFEN

PERRIGO

JUNIOR STRENGTH ADVIL

PFIZER

JUNIOR STRENGTH MOTRIN

+ J AND J CONSUMER INC

IBUPROFEN SODIUM

TABLET;ORAL

ADVIL

+ PFIZER CONS HLTHCARE

IBUPROFEN SODIUM

PERRIGO R AND D

100MG

N020267 002
Dec 13, 1996

100MG

A075367 001
Apr 22, 1999

100MG

N020602 001
Jun 10, 1996

200MG

N019012 003
Dec 17, 1990

200MG

A071265 001
Oct 15, 1986

200MG

A072095 001
Dec 08, 1987

50MG

N020944 001
Dec 18, 1998

50MG

N020601 001
Nov 15, 1996

50MG

100MG

A076359 001
Jan 16, 2004

A076359 002
Jan 16, 2004

100MG

N020944 002
Dec 18, 1998

100MG

N020601 003
Nov 15, 1996

EQ 200MG BASE

N201803 001
Jun 12, 2012

EQ 200MG BASE

A206581 001
Aug 03, 2015

IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

TABLET;ORAL

ADVIL CONGESTION RELIEF

+ PFIZER
200MG;10MG

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

PERRIGO R AND D
200MG;10MG

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE;ORAL

ADVIL COLD AND SINUS

+ PFIZER

EQ 200MG FREE ACID AND POTASSIUM

SALT;30MG

SUSPENSION;ORAL

CHILDREN'S ADVIL COLD

PFIZER

100MG/5ML;15MG/5ML

CHILDREN'S MOTRIN COLD

+ J AND J CONSUMER INC
100MG/5ML;15MG/5ML

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

PERRIGO
100MG/5ML;15MG/5ML

TABLET;ORAL

ADVIL COLD AND SINUS

+ PFIZER
200MG;30MG

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

CONTRACT PHARMACAL

200MG;30MG

DR REDDYS LABS LTD

200MG;30MG

IBUPROHM COLD AND SINUS

OHM LABS

200MG;30MG

SINE-AID IB

J AND J CONSUMER INC
200MG;30MG

INSULIN RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN R

+ LILLY

HUMULIN R PEN

+ LILLY

NOVOLIN R

+ NOVO NORDISK INC

4-10(of 18)

N022565 001
May 27, 2010

A203200 001
Jul 03, 2014

N021374 001
May 30, 2002

N021373 001
Apr 18, 2002

N021128 001
Aug 01, 2000

A076478 001
Nov 05, 2003

N019771 001
Sep 19, 1989

A075588 001
Apr 08, 2002

A077628 001
Aug 14, 2006

A074567 001
Apr 17, 2001

N019899 001
Dec 31, 1992

100 UNITS/ML

N018780 001
Oct 28, 1982

100 UNITS/ML

N018780 005
Aug 06, 1998

100 UNITS/ML

N019938 001
Jun 25, 1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-11(of 18)

OTC DRUG PRODUCT LIST

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN 70/30

+ LILLY
30 UNITS/ML;70 UNITS/ML
HUMULIN 70/30 PEN

+ LILLY
30 UNITS/ML;70 UNITS/ML
NOVOLIN 70/30

+ NOVO NORDISK INC

30 UNITS/ML;70 UNITS/ML
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN N

+ LILLY
100 UNITS/ML
NOVOLIN N

+ NOVO NORDISK INC
100 UNITS/ML

N019717 001 Apr 25, 1989

N019717 002 Aug 06, 1998

N019991 001 Jun 25, 1991

N018781 001 Oct 28, 1982

N019959 001 Jul 01, 1991

IODINE POVACRYLEX; ISOPROPYL ALCOHOL

SPONGE;TOPICAL

DURAPREP

+ 3M
EQ 0.7% IODINE;74% (6ML)
+
EQ 0.7% IODINE;74% (26ML)

N021586 001 Sep 29, 2006

N021586 002 Sep 29, 2006

KETOCONAZOLE

SHAMPOO;TOPICAL

NIZORAL A-D

+ JOHNSON AND JOHNSON

1%

N020310 001 Oct 10, 1997

EQ 0.025% BASE
EQ 0.035% BASE

N021996 001 Dec 01, 2006

N021996 002 Feb 11, 2015

EQ 0.025% BASE
EQ 0.025% BASE

A077958 001 Jul 26, 2007

A077200 001 Sep 02, 2008

EQ 0.025% BASE

N021066 002 Oct 19, 2006

KETOTIFEN FUMARATE

SOLUTION/DROPS;OPHTHALMIC

ALAWAY

+ BAUSCH AND LOMB
KETOTIFEN FUMARATE

AKORN
ALCON PHARMS LTD
ZADITOR

+ ALCON PHARMA

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

LANSOPRAZOLE

DR REDDYS LABS LTD
15MG
NATCO PHARMA LTD
15MG
PERRIGO R AND D
15MG
WOCKHARDT LTD
15MG
PREVACID 24 HR

+ NOVARTIS
15MG
LEVONORGESTREL

TABLET;ORAL

ATHENTIA NEXT

AUROBINDO PHARMA LTD
FALLBACK SOLO

LUPIN LTD
LEVONORGESTREL

JAI PHARMA LTD
LOTUS PHARM CO LTD
NOVEL LABS INC
OC PHARMA
PERRIGO R AND D
+

WATSON LABS
WATSON LABS INC
OPCICON ONE-STEP
SUN PHARM INDS LTD
PLAN B
+ TEVA BRANDED PHARM
PLAN B ONE-STEP
+ TEVA BRANDED PHARM

A202194
A203306
A202319
A202727

001
001
001
001

May
Jan
May
May

18,
13,
18,
18,

2012

2016

2012

2012

N022327 001 May 18, 2009

1.5MG

A206867 001 Dec 08, 2015

1.5MG

A201446 001 Jun 19, 2014

1.5MG
1.5MG
1.5MG
1.5MG
0.75MG
1.5MG
0.75MG
1.5MG

A202739
A202246
A202508
A202380
A090740
A202334
A078665
A200670

1.5MG

A202635 001 Sep 11, 2014

0.75MG

N021045 002 Aug 24, 2006

1.5MG

N021998 001 Jul 10, 2009

001
001
001
001
001
001
001
001

Oct
Jun
Feb
May
Dec
Aug
Aug
Jul

31,
05,
22,
29,
30,
20,
28,
12,

2014
2015
2013
2015
2010
2014
2009
2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-12(of 18)

OTC DRUG PRODUCT LIST

LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
LOPERAMIDE HYDROCHLORIDE
BANNER LIFE SCIENCES
+
SOLUTION;ORAL
IMODIUM A-D
+ J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE
HI TECH PHARMA
PERRIGO
ROXANE
WOCKHARDT
SUSPENSION;ORAL
IMODIUM A-D
+ J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE
PERRIGO R AND D
TABLET;ORAL
IMODIUM A-D
+ J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE
AUROBINDO PHARMA LTD
CONTRACT PHARMACAL
LNK
OHM LABS
PERRIGO
TABLET, CHEWABLE;ORAL
IMODIUM A-D EZ CHEWS
+ J AND J CONSUMER INC

1MG
2MG

N021855 001 Aug 04, 2005

N021855 002 Aug 04, 2005

1MG/5ML

N019487 001 Mar 01, 1988

1MG/5ML
1MG/5ML
1MG/5ML
1MG/5ML

A074352
A073243
A073079
A074730

1MG/7.5ML

N019487 002 Jul 08, 2004

1MG/7.5ML

A091292 001 May 20, 2011

2MG

N019860 001 Nov 22, 1989

2MG
2MG
2MG
2MG
2MG

A206548
A073254
A076497
A074091
A075232

2MG

N020448 001 Jul 24, 1997

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

TABLET;ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+ J AND J CONSUMER INC
2MG;125MG
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

SUN PHARM INDS LTD
2MG;125MG
TABLET, CHEWABLE;ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+ J AND J CONSUMER INC
2MG;125MG
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

PERRIGO
2MG;125MG
LORATADINE

CAPSULE;ORAL

CLARITIN

+ BAYER HEALTHCARE LLC
SUSPENSION;ORAL

LORATADINE

+ TARO
SYRUP;ORAL

CLARITIN

+ BAYER HEALTHCARE LLC
LORATADINE

PERRIGO
SILARX
TARO
TEVA
WOCKHARDT
TABLET;ORAL

CLARITIN

+ BAYER HEALTHCARE LLC
CLARITIN HIVES RELIEF

+ BAYER HEALTHCARE LLC
LORATADINE

APOTEX INC
MYLAN

PERRIGO
SANDOZ
SUN PHARM INDS LTD

001
001
001
001

001
001
001
001
001

Nov
Jan
Apr
Aug

Dec
Jul
Jun
Dec
Jan

17,
21,
30,
28,

15,
30,
10,
10,
06,

1995
1992
1992
1997

2015
1993
2003
1992
2000

N021140 001 Nov 30, 2000

A077500 001 Sep 06, 2006

N020606 001 Jun 26, 1996

A076029 001 Aug 30, 2002

10MG

N021952 001 Jun 16, 2008

1MG/ML

N021734 001 Oct 04, 2005

1MG/ML

N020641 002 Nov 27, 2002

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML

A075728
A077421
A076805
A201865
A075505
A075815

10MG

N019658 002 Nov 27, 2002

10MG

N019658 003 Nov 19, 2003

10MG
10MG
10MG
10MG
10MG
10MG
10MG

A076471
A075790
A076154
A078447
A076301
A075209
A076134

001
001
001
001
001
001

001
001
001
001
001
001
001

Aug
Jun
Aug
Jul
Nov
Aug

Feb
Nov
Aug
Aug
Jun
Jan
Aug

20,
29,
20,
31,
07,
20,

14,
07,
20,
12,
25,
21,
18,

2004

2006

2004

2015

2003

2004

2006

2008

2003

2011

2004

2003

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-13(of 18)

OTC DRUG PRODUCT LIST

LORATADINE

TABLET, CHEWABLE;ORAL

CHILDREN'S CLARITIN

+ BAYER HEALTHCARE LLC
5MG
TABLET, ORALLY DISINTEGRATING;ORAL

ALAVERT

PFIZER
10MG
CLARITIN HIVES RELIEF REDITAB

+ BAYER HEALTHCARE LLC
10MG
CLARITIN REDITABS
+ BAYER HEALTHCARE LLC
5MG
+
10MG
LORATADINE
ACTAVIS LABS FL INC
10MG
IMPAX LABS
10MG
PFIZER
10MG
LORATADINE REDIDOSE
SUN PHARM INDS LTD
10MG
LORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

CLARITIN-D

+ BAYER HEALTHCARE LLC
5MG;120MG
CLARITIN-D 24 HOUR

+ BAYER HEALTHCARE LLC 10MG;240MG
LORATADINE AND PSEUDOEPHEDRINE SULFATE

ACTAVIS LABS FL INC
10MG;240MG
IMPAX LABS
5MG;120MG
10MG;240MG
SUN PHARM INDS LTD
10MG;240MG
MENTHOL; METHYL SALICYLATE

PATCH;TOPICAL

SALONPAS

+ HISAMITSU PHARM CO

3%;10%
3%;10%

MICONAZOLE NITRATE

CREAM;TOPICAL, VAGINAL

MICONAZOLE 3 COMBINATION PACK

PERRIGO
2%;4%
MONISTAT 3 COMBINATION PACK

MEDTECH PRODUCTS
2%;4%
MONISTAT 3 COMBINATION PACK (PREFILLED)

+ MEDTECH PRODUCTS
2%;4%
CREAM;VAGINAL

MICONAZOLE 3

TARO
4%
MICONAZOLE 7

ACTAVIS MID ATLANTIC
2%
MICONAZOLE NITRATE

G AND W LABS INC
2%
PERRIGO
2%
PERRIGO R AND D
4%
TARO
2%
MONISTAT 3

+ MEDTECH PRODUCTS
4%
MONISTAT 7

+ MEDTECH PRODUCTS
2%
CREAM, SUPPOSITORY;TOPICAL, VAGINAL

M-ZOLE 3 COMBINATION PACK

ACTAVIS MID ATLANTIC
2%;200MG
MICONAZOLE 7 COMBINATION PACK

G AND W LABS
100MG;2%
MICONAZOLE NITRATE

PERRIGO R AND D
1.2GM;2%
MICONAZOLE NITRATE COMBINATION PACK

PERRIGO
200MG;200MG
MONISTAT 1 COMBINATION PACK

+ MEDTECH PRODUCTS
1.2GM;2%
MONISTAT 7 COMBINATION PACK

+ MEDTECH PRODUCTS
100MG;2%

N021891 001 Aug 23, 2006

N021375 001 Dec 19, 2002

N020704 003 Nov 19, 2003
N021993 001 Dec 12, 2006
N020704 002 Nov 27, 2002
A075990 001 Nov 03, 2003
A076011 001 Sep 29, 2003
A075822 001 Feb 10, 2003
A077153 001 Apr 11, 2007

N019670 002 Nov 27, 2002

N020470 002 Nov 27, 2002

A075706
A076050
A075989
A076557

001
001
001
001

Feb
Jan
Mar
Sep

21,
30,
04,
22,

2003

2003

2004

2004

N022029 001 Feb 20, 2008

N022029 002 Nov 05, 2012

A076357 001 Mar 30, 2004

N021261 003 Jun 17, 2003

N021261 001 Feb 02, 2001

A076773 001 Mar 02, 2005

A074164 001 Mar 29, 1996

A074366
A074760
A091366
A074444

001
001
001
001

Feb
May
Jan
Jan

22,
15,
15,
13,

1996

1997

2010

1997

N020827 001 Mar 30, 1998

N017450 002 Feb 15, 1991

A074926 001 Apr 16, 1999

A076585 001 Mar 26, 2004

A079114 001 Jun 02, 2010

A075329 001 Apr 20, 1999

N021308 001 Jun 29, 2001

N020288 002 Apr 26, 1993

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-14(of 18)

OTC DRUG PRODUCT LIST

MICONAZOLE NITRATE

CREAM, SUPPOSITORY;TOPICAL, VAGINAL

MONISTAT-3 COMBINATION PACK

+ MEDTECH PRODUCTS
2%;200MG
SUPPOSITORY;VAGINAL

MICONAZOLE NITRATE

ACTAVIS MID ATLANTIC
100MG
G AND W LABS
100MG
+ PERRIGO
100MG
MONISTAT 7
+ MEDTECH PRODUCTS
100MG

N020670 002 Apr 16, 1996

A073507 001 Nov 19, 1993

A074414 001 Apr 30, 1997
A074395 001 Mar 20, 1997
N018520 002 Feb 15, 1991

MINOXIDIL
AEROSOL, FOAM;TOPICAL
MEN'S ROGAINE
+ JOHNSON AND JOHNSON
5%
MINOXIDIL
PERRIGO ISRAEL
5%
WOMEN'S ROGAINE
+ JOHNSON AND JOHNSON
5%
SOLUTION;TOPICAL
MINOXIDIL (FOR MEN)
ACTAVIS MID ATLANTIC
2%
HI TECH PHARMA
2%
PERRIGO
2%
WOCKHARDT
2%
MINOXIDIL (FOR WOMEN)
HI TECH PHARMA
2%
PERRIGO
2%
MINOXIDIL EXTRA STRENGTH (FOR MEN)
ACTAVIS MID ATLANTIC
5%
AVACOR PRODS
5%
PERRIGO
5%
PERRIGO NEW YORK
5%
WOCKHARDT
5%
ROGAINE (FOR MEN)
+ JOHNSON AND JOHNSON
2%
ROGAINE (FOR WOMEN)
+ JOHNSON AND JOHNSON
2%
ROGAINE EXTRA STRENGTH (FOR MEN)
+ JOHNSON AND JOHNSON
5%
THEROXIDIL
EI INC
2%
5%

N021812 001 Jan 20, 2006

A091344 001 Apr 28, 2011
N021812 002 Feb 28, 2014

A074588
A074731
A075357
A074767

DR REDDYS LABS INC

GRANULES INDIA
MARKSANS PHARMA
PERRIGO
SUN PHARM INDS LTD

Apr
Dec
Jul
Feb

05,
24,
30,
28,

1996
1996
1999
1997

A074731 002 May 11, 2005

A075357 002 Jul 30, 1999
A075518
A075619
A075598
A075737
A075438

001
001
001
001
001

Nov
Nov
Jun
Mar
Feb

17,
17,
13,
15,
27,

2000
2000
2001
2002
2003

N019501 002 Feb 09, 1996

N019501 003 Feb 09, 1996
N020834 001 Nov 14, 1997
A078176 001 Nov 09, 2007
A076239 001 Aug 24, 2004

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

SOLUTION/DROPS;OPHTHALMIC
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
AKORN INC
0.025%;0.3%
ALTAIRE PHARMS INC
0.02675%;0.315%
NAPHCON-A
+ ALCON
0.025%;0.3%
OPCON-A
+ BAUSCH AND LOMB
0.02675%;0.315%
VISINE-A
+ JOHNSON AND JOHNSON
0.025%;0.3%
NAPROXEN SODIUM
CAPSULE;ORAL
NAPROXEN SODIUM
+ BANNER LIFE SCIENCES
TABLET;ORAL
ALEVE
+ BAYER
NAPROXEN SODIUM
AMNEAL PHARMS NY
CONTRACT PHARMACAL

001
001
001
001

A202795 001 Jan 24, 2013

A078208 001 Sep 27, 2010
N020226 001 Jun 08, 1994
N020065 001 Jun 08, 1994
N020485 001 Jan 31, 1996

EQ 200MG BASE

N021920 001 Feb 17, 2006

EQ 200MG BASE

N020204 002 Jan 11, 1994

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A079096
A074635
A074789
A075168
A091353
A090545
A074661
A091183

200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001
001

Dec
Jan
Feb
Jul
Sep
Mar
Jan
May

16,
13,
27,
28,
20,
16,
13,
20,

2008
1997
1997
1998
2011
2011
1997
2011

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-15(of 18)

OTC DRUG PRODUCT LIST

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ALEVE-D SINUS & COLD

+ BAYER
200MG;120MG
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

DR REDDYS LABS INC
EQ 220MG BASE;120MG
PERRIGO
EQ 200MG BASE;120MG
NICOTINE

FILM, EXTENDED RELEASE;TRANSDERMAL

HABITROL

+ DR REDDYS LABS INC
7MG/24HR
+
14MG/24HR
+
21MG/24HR
NICODERM CQ
+ SANOFI AVENTIS US
7MG/24HR
+
14MG/24HR
+
21MG/24HR
NICOTINE
AVEVA
7MG/24HR
14MG/24HR
21MG/24HR
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICORETTE
+ GLAXOSMITHKLINE
+
NICORETTE (MINT)
GLAXOSMITHKLINE
NICOTINE POLACRILEX
ACTAVIS LABS NY INC

PERRIGO

PERRIGO R AND D

WATSON LABS
THRIVE
NOVARTIS
TROCHE/LOZENGE;ORAL
COMMIT
GLAXOSMITHKLINE CONS
+
NICORETTE
GLAXOSMITHKLINE CONS
+
NICOTINE POLACRILEX
PERRIGO R AND D

EQ
EQ
EQ
EQ

2MG
2MG
4MG
4MG

BASE
BASE
BASE
BASE

N021076 001 Nov 29, 1999

A077381 001 Sep 27, 2006

A076518 001 Mar 17, 2004

N020076 004 Nov 12, 1999

N020076 005 Nov 12, 1999
N020076 006 Nov 12, 1999
N020165 006 Aug 02, 1996
N020165 005 Aug 02, 1996
N020165 004 Aug 02, 1996
A074612 002 Jul 28, 2003
A074612 003 Oct 20, 1997
A074612 001 Oct 20, 1997

N018612
N018612
N020066
N020066

002
004
002
004

Feb
Sep
Feb
Sep

09,
25,
09,
25,

1996
2000
1996
2000

EQ 2MG BASE
EQ 4MG BASE

N018612 003 Dec 23, 1998

N020066 003 Dec 23, 1998

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A074507
A076569
A078699
A079216
A074707
A076568
A078697
A079038
A079219
A076775
A076776
A076777
A076778
A076779
A076789
A078325
A078547
A078967
A091349
A078326
A078546
A078968
A091354
A079044

2MG
2MG
2MG
2MG
4MG
4MG
4MG
4MG
4MG
2MG
2MG
2MG
4MG
4MG
4MG
2MG
2MG
2MG
2MG
4MG
4MG
4MG
4MG
2MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Mar
Jul
Dec
Jul
Mar
Jul
Dec
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Oct
May
Apr
Jul
Oct
May
Apr
Jul
Jul

15,
29,
29,
08,
19,
29,
29,
08,
08,
16,
16,
16,
16,
16,
16,
30,
24,
23,
20,
30,
24,
23,
20,
08,

1999
2004
2008
2009
1999
2004
2008
2009
2009
2004
2004
2004
2004
2004
2004
2006
2007
2008
2011
2006
2007
2008
2011
2009

EQ 2MG BASE
EQ 4MG BASE

A077658 001 Jun 19, 2007

A077656 001 Jun 19, 2007

EQ 2MG BASE
EQ 4MG BASE

N021330 001 Oct 31, 2002

N021330 002 Oct 31, 2002

EQ 2MG BASE
EQ 4MG BASE

N022360 001 May 18, 2009

N022360 002 May 18, 2009

EQ
EQ
EQ
EQ

A077007
A090711
A090821
A203690

2MG
2MG
2MG
2MG

BASE
BASE
BASE
BASE

001
001
001
001

Jan
Jul
Jul
Oct

31,
10,
10,
09,

2006
2009
2009
2012

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-16(of 18)

OTC DRUG PRODUCT LIST

NICOTINE POLACRILEX

TROCHE/LOZENGE;ORAL

NICOTINE POLACRILEX

EQ
EQ
EQ
EQ

4MG
4MG
4MG
4MG

BASE

BASE

BASE

BASE

A077007
A090711
A090821
A203690

002
002
002
002

Jan
Jul
Jul
Oct

31,
10,
10,
09,

2006

2009

2009

2012

NIZATIDINE

TABLET;ORAL

AXID AR

+ PFIZER

75MG

N020555 001 May 09, 1996

NONOXYNOL-9

SPONGE;VAGINAL

TODAY

+ MAYER LABS INC

1GM

N018683 001 Apr 01, 1983

OMEPRAZOLE

TABLET, DELAYED RELEASE;ORAL

OMEPRAZOLE

+ DEXCEL PHARMA

20MG

OMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED RELEASE;ORAL

OMEPRAZOLE MAGNESIUM

+ DR REDDYS LABS LTD

EQ 20MG BASE

TABLET, DELAYED RELEASE;ORAL

OMEPRAZOLE MAGNESIUM

PERRIGO R AND D

EQ 20MG BASE

PRILOSEC OTC

+ ASTRAZENECA PHARMS

EQ 20MG BASE

OMEPRAZOLE; SODIUM BICARBONATE

CAPSULE;ORAL

ZEGERID OTC

+ BAYER HEALTHCARE LLC
20MG;1.1GM

FOR SUSPENSION;ORAL

ZEGERID OTC

+ BAYER HEALTHCARE LLC
20MG/PACKET;1.68GM/PACKET

ORLISTAT

CAPSULE;ORAL

ALLI

+ GLAXOSMITHKLINE CONS

60MG

OXYBUTYNIN

FILM, EXTENDED RELEASE;TRANSDERMAL

OXYTROL FOR WOMEN

+ BAYER HEALTHCARE LLC
3.9MG/24HR

OXYMETAZOLINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

OCUCLEAR

BAYER HEALTHCARE LLC

VISINE L.R.

+ JOHNSON AND JOHNSON

PERMETHRIN

LOTION;TOPICAL

NIX

+ MEDTECH PRODUCTS

PERMETHRIN

ACTAVIS MID ATLANTIC

PERRIGO NEW YORK

POLYETHYLENE GLYCOL 3350

FOR SOLUTION;ORAL

GLYCOLAX

KREMERS URBAN PHARMS

MIRALAX

+ BAYER HEALTHCARE LLC

POLYETHYLENE GLYCOL 3350

ANI PHARMS INC

MYLAN

N022032 001 Dec 04, 2007

A078878 001 Jun 05, 2009

A204152 001 Jul 30, 2015

N021229 001 Jun 20, 2003

N022281 001 Dec 01, 2009

N022283 001 Jun 17, 2013

N021887 001 Feb 07, 2007

N202211 001 Jan 25, 2013

0.025%

N018471 001 May 30, 1986

0.025%

N019407 001 Mar 31, 1989

1%

N019918 001 May 02, 1990

1%

1%

A075014 001 Mar 28, 2000

A076090 001 Dec 20, 2001

17GM/PACKET

17GM/SCOOPFUL

A090600 001 Oct 06, 2009

A090600 002 Oct 06, 2009

17GM/SCOOPFUL

N022015 001 Oct 06, 2006

17GM/SCOOPFUL

17GM/PACKET

17GM/SCOOPFUL

A202850 001 Dec 15, 2015

A078915 001 Oct 06, 2009

A078915 002 Oct 06, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

4-17(of 18)

OTC DRUG PRODUCT LIST

POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
POLYETHYLENE GLYCOL 3350
NEXGEN PHARMA
NOVEL LABS INC
PAR PHARM
PERRIGO R AND D
RARITAN PHARMS INC
POTASSIUM IODIDE
SOLUTION;ORAL
THYROSHIELD
+ ARCO PHARMS LLC
TABLET;ORAL
IOSAT
ANBEX
+
THYROSAFE
+ RECIP
POVIDONE-IODINE
SOLUTION;TOPICAL
POVIDONE IODINE
+ ALLEGIANCE HLTHCARE
SPONGE;TOPICAL
E-Z SCRUB 201
+ BECTON DICKINSON
E-Z SCRUB 241
+ BECTON DICKINSON

17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/PACKET
17GM/SCOOPFUL
17GM/SCOOPFUL

A090812
A091077
A079214
A090685
A090685
A202071

001
001
001
001
002
001

Oct
Oct
Jan
Oct
Oct
Dec

07,
06,
31,
06,
06,
28,

2009
2009
2013
2009
2009
2012

65MG/ML

A077218 001 Jan 12, 2005

65MG
130MG

N018664 002 May 12, 2011

N018664 001 Oct 14, 1982

65MG

A076350 001 Sep 10, 2002

1%

N019522 001 Mar 31, 1989

20%

N019240 001 Nov 29, 1985

10%

N019476 001 Jan 07, 1987

PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO
120MG
SUN PHARM INDS LTD
120MG
SUDAFED 12 HOUR
+ MCNEIL CONS
120MG
SUDAFED 24 HOUR
+ J AND J CONSUMER INC
240MG

N020021 002 Dec 15, 1992

PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
AFRINOL
+ SCHERING PLOUGH
120MG

N018191 001

PURIFIED WATER
SOLUTION;OPHTHALMIC
PUR-WASH
+ NIAGARA PHARMS

98.3%

N022305 001 Sep 01, 2011

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A200172
A075094
A075294
A078192
A075296
A075497
A076195
A091429
A091429
A201745
A200536
A075167
A076760

RANITIDINE HYDROCHLORIDE
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
APOTEX INC
CONTRACT PHARMACAL
DR REDDYS LABS LTD
IVAX SUB TEVA PHARMS
MYLAN
PERRIGO
PERRIGO R AND D
SHASUN CHEMS
SVADS HOLDINGS SA
TORPHARM
WOCKHARDT
ZANTAC 150
+ BOEHRINGER INGELHEIM
ZANTAC 75
BOEHRINGER INGELHEIM

150MG BASE
75MG BASE
75MG BASE
150MG BASE
75MG BASE
75MG BASE
75MG BASE
150MG BASE
150MG BASE
75MG BASE
150MG BASE
75MG BASE
75MG BASE

A075153 001 Feb 26, 1999

A077442 001 Sep 28, 2005
A073585 001 Oct 31, 1991

001
001
001
001
001
001
001
001
002
001
001
001
001

May
Jun
Mar
Aug
Jan
Jan
Aug
May
May
Feb
Jun
May
Feb

31,
21,
28,
31,
14,
14,
30,
11,
11,
29,
28,
04,
24,

2012
1999
2000
2007
2000
2000
2002
2011
2011
2012
2011
2000
2006

EQ 150MG BASE
EQ 150MG BASE

N021698 001 Aug 31, 2004

N021698 002 Mar 13, 2007

EQ 75MG BASE

N020520 001 Dec 19, 1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST

4-18(of 18)

SODIUM CHLORIDE
AEROSOL, METERED;INHALATION
BRONCHO SALINE
+ BLAIREX

0.9%

N019912 001 Sep 03, 1992

SODIUM FLUORIDE; TRICLOSAN

PASTE;DENTAL
COLGATE TOTAL
+ COLGATE PALMOLIVE

0.24%;0.3%

N020231 001 Jul 11, 1997

TERBINAFINE
GEL;TOPICAL
LAMISIL AT
+ NOVARTIS

1%

N021958 001 Jul 24, 2006

1%

N020980 001 Mar 09, 1999

1%

A077511 001 Jul 02, 2007

1%

N021124 001 Mar 17, 2000

1%

N021124 002 Mar 17, 2000

TERBINAFINE HYDROCHLORIDE
CREAM;TOPICAL
LAMISIL
+ NOVARTIS
TERBINAFINE HYDROCHLORIDE
TARO
SOLUTION;TOPICAL
LAMISIL AT
+ NOVARTIS
SPRAY;TOPICAL
LAMISIL AT
+ NOVARTIS
TIOCONAZOLE
OINTMENT;VAGINAL
TIOCONAZOLE
PERRIGO
VAGISTAT-1
+ NOVARTIS

6.5%

A075915 001 Nov 21, 2001

6.5%

N020676 001 Feb 11, 1997

TRIAMCINOLONE ACETONIDE
SPRAY, METERED;NASAL
NASACORT ALLERGY 24 HOUR
+ SANOFI AVENTIS US

0.055MG/SPRAY

N020468 002 Oct 11, 2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

5 - 1 of 4

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT 4% SODIUM CITRATE SOLUTION USP
INJECTABLE; INJECTION
NONE
HAEMONETICS
MANUFACTURING INC

N760305

Jun 30, 1978

N020037

Aug 26, 2003

A010228

Feb 25, 2002

N000922

Aug 29, 2002

A980728

Feb 06, 2002

N001214

May 29, 2002

A710497

Nov 06, 1987

N160918

Mar 17, 1978

A110057

May 11, 2012

N000127

Jan 18, 2002

N820528

Nov 03, 1982

ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD)

INJECTABLE; INJECTION

CITRA LABS LLC

ACD-A SOLUTION
TERUMO BCT INC
ADSOL WITH ACD-A
FENWAL INC
ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A
HAEMONETICS CORP
AS3 SOLUTION/ACD-A
TERUMO BCT INC
NONE
HAEMONETICS
MANUFACTURING INC

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP

INJECTABLE; INJECTION
NONE
FENWAL INC

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD-A)

INJECTABLE; INJECTION
NONE
ARTERIOCYTE MEDICAL
SYSTEMS, INC

ANTICOAGULANT CITRATE PHOSPHATE 2X DEXTROSE SOLUTION (CP2D)

INJECTABLE; INJECTION
CITRATE PHOSPHATE DOUBLE DEXTROSE/ADDITIVE SOLUTION 3
HAEMONETICS CORP

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION

INJECTABLE; INJECTION
NONE
TERUMO MEDICAL CORP

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION (CPDA)

INJECTABLE; INJECTION
CPDA-1 BLOOD-PACK UNIT (PL 146 PLASTIC) 250, 450, 500 ML BLOOD PACK UNITS
FENWAL INC
N770420

May 12, 1978

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION USP

INJECTABLE; INJECTION
BLOOD PACK UNIT CPDA-1 IN PLASTIC CONTAINER
FENWAL INC

N940404

Jul 28, 1994

N800077

Nov 06, 1980

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE-1 SOLUTION

INJECTABLE; INJECTION
NONE
HAEMONETICS
MANUFACTURING INC

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

5 - 2 of 4

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION
INJECTABLE; INJECTION
ADSOL IN PLASTIC CONTAINER
FENWAL INC

N900223

Dec 27, 1991

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)

INJECTABLE; INJECTION
CPD ANTICOAGULANT IN PL 2209 PLASTIC CONTAINER
FENWAL INC
N900224
Dec 27, 1991
MACOPRODUCTIONS SAS CPD/AS-1: MACOPHARMA LEUCOFLEX MTL1 LEUKOREDUCTION SYSTEM FOR BLOOD
COMPONENTS KNOWN AS MTL1-WB
MACOPRODUCTIONS SAS
N040083
Nov 21, 2005
NONE
TERUMO BCT INC
A070025
Jan 06, 2008

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP

INJECTABLE; INJECTION
NONE
FENWAL INC

HAEMONETICS
MANUFACTURING INC
TERUMO MEDICAL CORP

N170401
N811012
N800222

Dec 06, 1977

Jun 28, 1983
Aug 23, 1982

N781211

Jun 10, 1981

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-1:

DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
ADSOL RED BLOOD CELL PRESERVATIVE SOLUTION
FENWAL INC

N811104

May 16, 1983

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-5:

DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
OPTISOL RED BLOOD CELL PRESERVATIVE SOLUTION
TERUMO MEDICAL CORP

N880217

Oct 07, 1988

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-3: CITRIC ACID USP; MONOBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP

INJECTABLE; INJECTION
AS-3 NUTRICEL ADDITIVE SYSTEM
HAEMONETICS
0.042GM/100ML;0.276GM/100ML;
MANUFACTURING INC
0.410GM/100ML;0.30GM/100ML;
1.10GM/100ML;0.588GM/100ML

N820915

Oct 19, 1984

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-2: CITRIC ACID USP; DIBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP

INJECTABLE; INJECTION
AS-2 NUTRICEL ADDITIVE SYSTEM
MEDSEP CORP
0.042GM/100ML;0.285GM/100ML;
0.718GM/100ML;0.017GM/100ML;
0.396GM/100ML;0.588GM/100ML

N820915

Sep 22, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

5 - 3 of 4

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT SODIUM CITRATE 4% SOLUTION
INJECTABLE; INJECTION
NONE
HAEMONETICS
CORPORATION

N980123

Mar 03, 2000

N010409

Jul 10, 2003

N770923
N781214

Jan 20, 1978

Feb 08, 1980

N830715

Oct 30, 1984

10GM/100ML;5GM/100ML

A720563

Oct 30, 1992

10GM/100ML;5GM/100ML

N160767

Apr 06, 1970

A720562

Oct 30, 1992

N160767

Apr 06, 1970

N090024

Aug 18, 1969

N200952

Mar 31, 1999

ANTICOAGULANT SODIUM CITRATE SOLUTION

INJECTABLE; INJECTION
TRICITRASOL
CYTOSOL
LABORATORIES INC

ANTICOAGULANT SODIUM CITRATE SOLUTION USP

INJECTABLE; INJECTION
NONE
FENWAL INC
TERUMO MEDICAL CORP

DEXTRAN 1 IN SODIUM CHLORIDE 0.6%

INJECTABLE; INJECTION
PROMIT
MEDA AB

DEXTRAN 40, 10% IN DEXTROSE 5%

INJECTABLE; INJECTION
LMD IN GLASS BOTTLE
HOSPIRA INC
NONE
B BRAUN MEDICAL INC

DEXTRAN 40, 10% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
LMD IN PLASTIC CONTAINER
HOSPIRA INC
10GM/100ML;0.9GM/100ML
NONE
B BRAUN MEDICAL INC
10GM/100ML;0.9GM/100ML

DEXTRAN 70, 6% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
NONE
B BRAUN MEDICAL INC

6GM/100ML;0.9 GM/100ML

HETASTARCH 6% IN LACTATED ELECTROLYTE INJECTION

INJECTABLE; INJECTION
HEXTEND
BIOTIME INC

6GM/100ML

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

5 - 4 of 4

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

HETASTARCH 6% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
6% HETASTARCH IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA INC
6GM/100ML;0.9GM/100ML
HESPAN IN PLASTIC CONTAINER
B BRAUN MEDICAL INC
6GM/100ML;0.9GM/100ML
NONE
B BRAUN MEDICAL INC
6GM/100ML;0.9GM/100ML
TEVA PARENTERAL
6GM/100ML;0.9GM/100ML
MEDICINES INC

A740193

Jan 30, 1995

N890105

Apr 04, 1991

A740283
A740592

Oct 21, 1998

Nov 12, 1998

A110013

Jan 09, 2015

N070012

Dec 27, 2007

N90067

Mar 05, 2013

HYDROXYETHYL STARCH 130/0.4 IN 6% SODIUM CHLORIDE 0.9%

STORAGE/PROCESSING SOLUTION ONLY; SHOULD NEVER BE
INFUSED DIRECTLY TO THE PATIENT.
NONE
B. BRAUN MEDICAL
VOLUVEN
FRESENIUS KABI
6GM/100ML;0.9GM/100ML
DEUTSCHLAND GMBH

ISOPLATE SOLUTION IN THE 500 ML EXCEL CONTAINER

STORAGE/PROCESSING SOLUTION ONLY; SHOULD NEVER BE
INFUSED DIRECTLY TO THE PATIENT.
ISOPLATE SOLUTION
HAEMONETICS CORP

LEUKOCYTE REDUCTION FILTRATION SYSTEM FOR WHOLE BLOOD WITH CPD ANTICOAGULANT AND
SOLX ADDITIVE
INJECTABLE; INJECTION
LEUKOSEP HWB-600-XL
HAEMONETICS CORP

N110059

Apr 25, 2013

N890104

Apr 04, 1991

N950522

Feb 26, 1997

PENTASTARCH 10% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
PENTASPAN IN PLASTIC CONTAINER
B BRAUN MEDICAL INC
10GM/100ML;0.9GM/100ML

RED BLOOD CELL PROCESSING SOLUTION

STORAGE/PROCESSING SOLUTION ONLY; SHOULD NEVER BE

INFUSED DIRECTLY TO THE PATIENT.
REJUVESOL
CITRA LABS LLC

SODIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE,

DIBASIC ANHYDROUS; SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE
STORAGE/PROCESSING SOLUTION ONLY; SHOULD NEVER BE
INFUSED DIRECTLY TO THE PATIENT.
INTERSOL SOLUTION
FENWAL INC.
2.26G/500ML; 2.21G/500ML; 1.59G/500ML;
1.53G/500ML; 0.465G/500ML

N080041

Dec 09, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-1(of 347)

DISCONTINUED DRUG PRODUCT LIST

ABARELIX

INJECTABLE;INTRAMUSCULAR

PLENAXIS

SPECIALITY EUROPEAN

ACEBUTOLOL HYDROCHLORIDE

CAPSULE;ORAL

ACEBUTOLOL HYDROCHLORIDE

WATSON LABS

ACETAMINOPHEN

INJECTABLE;INJECTION

INJECTAPAP

ORTHO MCNEIL PHARM

SUPPOSITORY;RECTAL

ACEPHEN

G AND W LABS

ACETAMINOPHEN

ABLE

ROXANE

100MG/VIAL

N021320 001 Nov 25, 2003

EQ 200MG BASE

EQ 400MG BASE

A074007 001 Oct 18, 1995

A074007 002 Oct 18, 1995

100MG/ML

N017785 001 Mar 07, 1986

120MG

A072218 001 Mar 27, 1992

120MG

325MG

650MG

120MG

650MG

A073106
A073107
A073108
A071010
A071011

TYLENOL

J AND J CONSUMER INC

120MG

650MG

TABLET, EXTENDED RELEASE;ORAL

ACETAMINOPHEN

SUN PHARM INDS LTD

650MG

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

CAPSULE;ORAL

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

MIKART
150MG;180MG;15MG

150MG;180MG;30MG

150MG;180MG;60MG

CODEINE, ASPIRIN, APAP FORMULA NO. 2

SCHERER LABS
150MG;180MG;15MG

CODEINE, ASPIRIN, APAP FORMULA NO. 3

SCHERER LABS
150MG;180MG;30MG

CODEINE, ASPIRIN, APAP FORMULA NO. 4

SCHERER LABS
150MG;180MG;60MG

ACETAMINOPHEN; BUTALBITAL

CAPSULE;ORAL

BANCAP

FOREST PHARMS

325MG;50MG

BUCET

MALLINCKRODT

650MG;50MG

PHRENILIN FORTE

VALEANT

650MG;50MG

TENCON

MALLINCKRODT

650MG;50MG

TRIAPRIN

DUNHALL

325MG;50MG

TABLET;ORAL

BUTALBITAL AND ACETAMINOPHEN

HALSEY
325MG;50MG

WATSON LABS
325MG;50MG

BUTAPAP

MIKART
650MG;50MG

PHRENILIN

VALEANT
325MG;50MG

SEDAPAP

MAYRAND
650MG;50MG

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

ANOQUAN

SHIRE
325MG;50MG;40MG

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

GRAHAM DM
325MG;50MG;40MG

325MG;50MG;40MG

325MG;50MG;40MG

001
001
001
001
001

Feb
Feb
Feb
May
May

27,
27,
27,
12,
12,

1995

1995

1995

1987

1987

N017756 002

N017756 001

A090205 001 Nov 18, 2009

A081095 001 Oct 26, 1990

A081096 001 Oct 26, 1990

A081097 001 Oct 26, 1990

A085640 001

A085639 001

A085638 001

A088889 001 Jan 16, 1986

A088991 001 Jun 28, 1985

A088831 001 Jun 19, 1985

A089405 001 May 15, 1990

A089268 001 Jul 02, 1987

A089568 001 Oct 05, 1988

A087550 001 Oct 19, 1984

A089988 001 Oct 26, 1992

A087811 001 Jun 19, 1985

A088944 001 Oct 17, 1985

A087628 001 Oct 01, 1986

A088743 001 Jul 18, 1985

A088765 001 Mar 27, 1985

A089067 001 Apr 19, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-2(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
HIKMA PHARMS LLC
500MG;50MG;40MG
MALLINCKRODT
325MG;50MG;40MG
BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE
GILBERT LABS
325MG;50MG;40MG
ESGIC-PLUS
MIKART
500MG;50MG;40MG
FEMCET
MALLINCKRODT
325MG;50MG;40MG
MEDIGESIC PLUS
US CHEM
325MG;50MG;40MG
TRIAD
MALLINCKRODT
325MG;50MG;40MG
TABLET;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ABLE
325MG;50MG;40MG
500MG;50MG;40MG
GILBERT LABS
325MG;50MG;40MG
HIKMA PHARMS LLC
500MG;50MG;40MG
MIKART
750MG;50MG;40MG
MIRROR PHARMS
325MG;50MG;40MG
MIRROR PHARMS LLC
500MG;50MG;40MG
MUTUAL PHARM
325MG;50MG;40MG
VINTAGE PHARMS
500MG;50MG;40MG
WATSON LABS
325MG;50MG;40MG
500MG;50MG;40MG
ESGIC
FOREST PHARMS
325MG;50MG;40MG
ESGIC-PLUS
MIKART
500MG;50MG;40MG
FIORICET
ACTAVIS LABS UT INC
325MG;50MG;40MG
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ABLE
325MG;50MG;40MG;30MG
PHRENILIN WITH CAFFEINE AND CODEINE
VALEANT
325MG;50MG;40MG;30MG
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
CAPSULE;ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
MIKART
356.4MG;30MG;16MG
WRASER PHARMS LLC
356.4MG;30MG;16MG
DHC PLUS
PHARM RES ASSOC
356.4MG;30MG;16MG
SYNALGOS-DC-A
LEITNER PHARMS
356.4MG;30MG;16MG
TABLET;ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
BOCA PHARMA LLC
712.8MG;60MG;32MG
MIKART
712.8MG;60MG;32MG
WEST-WARD PHARM CORP
712.8MG;60MG;32MG
ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET;ORAL
TAVIST ALLERGY/SINUS/HEADACHE
NOVARTIS
500MG;EQ 0.25MG BASE;30MG
ACETAMINOPHEN; CODEINE PHOSPHATE
CAPSULE;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
TEVA
300MG;15MG
300MG;30MG
300MG;60MG
PHENAPHEN W/ CODEINE NO. 2
ROBINS AH
325MG;15MG
PHENAPHEN W/ CODEINE NO. 3
ROBINS AH
325MG;30MG
PHENAPHEN W/ CODEINE NO. 4
ROBINS AH
325MG;60MG

A040261 001 Oct 28, 1998

A088758 001 Mar 27, 1985
A088825 001 Dec 05, 1984
A040085 001 Mar 28, 1996
A089102 001 Jun 19, 1985
A089115 001 Jan 14, 1986
A089023 001 Jun 19, 1985

A040390
A040394
A087629
A040336
A040496
A040864
A040883
A040601
A040513
A089536
A040267

001
001
001
001
001
001
001
001
001
001
001

Jul
Jul
Nov
Aug
Dec
Dec
Dec
Jul
Aug
Feb
Jul

23,
23,
13,
18,
23,
01,
23,
29,
25,
16,
30,

2001
2001
1984
1999
2003
2008
2008
2005
2003
1988
1998

A089660 001 Dec 23, 1988

A089451 001 May 23, 1988
A088616 001 Nov 09, 1984

A076528 001 Aug 21, 2003

A074911 001 Aug 22, 2001

A040109 001 Aug 26, 1997

A040688 001 Apr 03, 2007
A088584 001 Mar 04, 1986
A089166 001 May 14, 1986

A040701 001 Apr 03, 2007

A040316 001 Apr 28, 1999
A040637 001 Sep 22, 2006

N021082 001 Mar 01, 2001

A088537 001 Jun 04, 1984

A088324 001 Dec 29, 1983
A088599 001 Jun 01, 1984
A084444 001
A084445 001
A084446 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-3(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; CODEINE PHOSPHATE
CAPSULE;ORAL
PROVAL #3
SOLVAY
325MG;30MG
TYLENOL W/ CODEINE NO. 3
ORTHO MCNEIL PHARM
300MG;30MG
TYLENOL W/ CODEINE NO. 4
ORTHO MCNEIL PHARM
300MG;60MG
SOLUTION;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
ACTAVIS MID ATLANTIC
120MG/5ML;12MG/5ML
DAVA PHARMS INC
120MG/5ML;12MG/5ML
ROXANE
120MG/5ML;12MG/5ML
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM
120MG/5ML;12MG/5ML
SUSPENSION;ORAL
CAPITAL AND CODEINE
ACTAVIS MID ATLANTIC
120MG/5ML;12MG/5ML
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
ABLE
300MG;30MG
300MG;60MG
AM THERAP
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
DURAMED PHARMS BARR
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
EVERYLIFE
325MG;30MG
HALSEY
300MG;15MG
300MG;30MG
300MG;60MG
KV PHARM
300MG;30MG
300MG;60MG
325MG;15MG
325MG;45MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
LEDERLE
300MG;30MG
MIKART
300MG;30MG
300MG;60MG
650MG;30MG
650MG;60MG
MUTUAL PHARM
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
PURACAP PHARM
300MG;30MG
PUREPAC PHARM
300MG;30MG
300MG;30MG
300MG;60MG
ROXANE
300MG;15MG
300MG;30MG
300MG;60MG
500MG;15MG
500MG;30MG
500MG;60MG
SANDOZ
300MG;15MG
300MG;30MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
300MG;60MG

A085685 001
A087422 001
A087421 001

A085861 001
A040098 001 Sep 20, 1996
A086366 001
A085057 001

A085883 001

A040452
A040459
A089478
A089481
A089479
A089482
A089480
A089483
A040223
A088353
A040223
A088354
A040223
A088355
A085217
A083871
A083872
A086549
A085288
A085365
A085364
A085363

001
001
001
001
001
001
001
001
001
001
002
001
003
001
001
001
001
001
001
001
001
001

A087141
A089238
A089244
A089231
A089363
A085795
A089671
A085794
A089672
A087653
A089673
A087762
A086681
A089080
A086683
A084659
A084656
A084667
A089511
A089512
A089513
A087433
A081250
A085291
A085917
A081249
A085964
A087423

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001

Aug
Aug
Mar
Mar
Mar
Mar
Mar
Mar
Nov
Feb
Nov
Feb
Nov
Feb

01,
01,
03,
03,
03,
03,
03,
03,
18,
06,
18,
06,
18,
06,

2002
2002
1987
1987
1987
1987
1987
1987
1997
1984
1997
1984
1997
1984

Feb
Feb
Mar
Sep

25,
25,
03,
09,

1986
1986
1986
1991

Feb 10, 1988

Feb
Apr
Feb
Dec

10,
13,
10,
10,

1988
1982
1988
1982

Jul 17, 1986

Apr 25, 1989

Apr 25, 1989
Apr 25, 1989
Jul 16, 1992

Jul 16, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-4(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; CODEINE PHOSPHATE
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
SUPERPHARM
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
USL PHARMA
300MG;30MG
300MG;60MG
VALEANT PHARM INTL
300MG;30MG
VITARINE
300MG;30MG
WARNER CHILCOTT
300MG;15MG
300MG;30MG
300MG;60MG
WATSON LABS
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
WATSON LABS FLORIDA
300MG;15MG
300MG;30MG
300MG;60MG
WHITEWORTH TOWN PLSN
300MG;30MG
300MG;60MG
CAPITAL AND CODEINE
CARNRICK
325MG;30MG
CODRIX
WATSON LABS FLORIDA
500MG;15MG
500MG;30MG
500MG;60MG
EMPRACET W/ CODEINE PHOSPHATE #3
GLAXOSMITHKLINE
300MG;30MG
EMPRACET W/ CODEINE PHOSPHATE #4
GLAXOSMITHKLINE
300MG;60MG
PAPA-DEINE #3
VANGARD
300MG;30MG
PAPA-DEINE #4
VANGARD
300MG;60MG
PHENAPHEN-650 W/ CODEINE
ROBINS AH
650MG;30MG
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM
325MG;7.5MG **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
325MG;15MG **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
325MG;30MG **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
325MG;60MG **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
TYLENOL W/ CODEINE NO. 1
JANSSEN PHARMS
300MG;7.5MG
TYLENOL W/ CODEINE NO. 2
JANSSEN PHARMS
300MG;15MG
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
DRIXORAL PLUS
SCHERING PLOUGH
500MG;3MG;60MG

A089183
A089184
A089253
A089185
A089254
A087919
A087920
A085896
A085676
A085992
A085218
A087306
A087277
A089997
A087276
A089998
A087275
A089999
A040443
A040443
A040443
A084360
A085607

001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
002
003
001
001

Oct
Oct
May
Oct
May
Jun
Jun

18,
18,
19,
18,
19,
22,
22,

1985
1985
1986
1985
1986
1982
1982

May
Dec
May
Dec
May
Dec
Jan
Jan
Jan

26,
28,
26,
28,
26,
28,
22,
22,
22,

1982
1994
1982
1994
1982
1994
2003
2003
2003

A083643 001
A040447 001 Feb 26, 2003
A040441 001 Mar 27, 2003
A040488 001 Mar 28, 2003
A083951 001
A083951 002
A088037 001 Mar 20, 1984
A088715 001 Mar 20, 1984
A085856 001
A085056 001
or
A085056 002
or
A085056 003
or
A085056 004
or

A085055 001
A085055 002

N019453 001 May 22, 1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-5(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; HYDROCODONE BITARTRATE
CAPSULE;ORAL
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
CENT PHARMS
500MG;5MG
ALLAY
IVAX PHARMS
500MG;5MG
BANCAP HC
FOREST PHARMS
500MG;5MG
CO-GESIC
CENT PHARMS
500MG;5MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT
500MG;5MG
500MG;5MG
MIKART
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
LORCET-HD
MALLINCKRODT
500MG;5MG
SOLUTION;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT
500MG/15ML;7.5MG/15ML
MALLINCKRODT INC
500MG/15ML;10MG/15ML
MIKART
500MG/15ML;5MG/15ML
500MG/15ML;5MG/15ML
500MG/15ML;7.5MG/15ML
NESHER PHARMS
500MG/15ML;7.5MG/15ML
PHARM ASSOC
500MG/15ML;7.5MG/15ML
VINTAGE PHARMS
500MG/15ML;7.5MG/15ML
TABLET;ORAL
ANEXSIA
MALLINCKRODT
500MG;5MG
750MG;10MG
ANEXSIA 7.5/650
MALLINCKRODT
650MG;7.5MG
CO-GESIC
UCB INC
500MG;5MG
DURADYNE DHC
FOREST PHARMS
500MG;5MG
HY-PHEN
ASCHER
500MG;5MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ABLE
325MG;5MG
325MG;7.5MG
325MG;10MG
500MG;5MG
500MG;7.5MG
500MG;10MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
ACTAVIS LABS FL INC
500MG;10MG
AMNEAL PHARMS NY
500MG;5MG
500MG;7.5MG
500MG;10MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
BARR
500MG;2.5MG
500MG;5MG
500MG;5MG
500MG;7.5MG
500MG;10MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
CARACO
500MG;5MG
500MG;7.5MG
500MG;10MG
650MG;7.5MG
650MG;10MG

A088898 001 Mar 27, 1985

A089907 001 Jan 13, 1989
A087961 001 Mar 17, 1983
A089360 001 Mar 02, 1988
A088956
A089006
A081067
A081068
A081069
A081070
A089008

001
001
001
001
001
001
001

Jul
Aug
Nov
Nov
Nov
Nov
Feb

19,
09,
30,
30,
30,
30,
21,

1985
1985
1989
1989
1989
1989
1986

A087336 001 Jul 08, 1982

A040418
A040508
A081226
A089557
A081051
A040366
A040182
A040520

001
001
001
001
001
001
001
001

Jun
Aug
Oct
Apr
Aug
Jan
Mar
Oct

27,
29,
27,
29,
28,
23,
13,
30,

2001
2003
1992
1992
1992
2002
1998
2003

A089160 001 Apr 23, 1987

A040468 001 Oct 31, 2002
A089725 001 Sep 30, 1987
A087757 001 May 03, 1982
A087809 001 Mar 17, 1983
A087677 001 May 03, 1982
A040478
A040464
A040464
A040477
A040490
A040473
A040474
A040476
A040469
A040148
A040729
A040748
A040813
A040754
A040757
A040769
A040307
A040308
A088577
A040307
A040309
A040307
A040307
A040308
A090265
A090265
A090265
A090380
A090380

001
001
002
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
002
001
003
004
002
001
002
003
001
002

Nov
Oct
Oct
Nov
May
Nov
Jan
Oct
Oct
Feb
Aug
Aug
Feb
Aug
Aug
Aug
Jul
Jul
Dec
Jul
Jul
Jul
Jul
Jul
Dec
Dec
Dec
Dec
Dec

08,
23,
23,
06,
21,
06,
02,
23,
25,
14,
25,
25,
23,
25,
25,
28,
26,
26,
21,
26,
26,
26,
26,
26,
23,
23,
23,
23,
23,

2002
2002
2002
2002
2003
2002
2003
2002
2002
1997
2006
2006
2007
2006
2006
2006
2000
2000
1984
2000
2000
2000
2000
2000
2008
2008
2008
2008
2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-6(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; HYDROCODONE BITARTRATE

TABLET;ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

660MG;10MG

750MG;7.5MG

HALSEY

500MG;5MG

IVAX PHARMS

500MG;5MG

MALLINCKRODT

500MG;5MG

500MG;7.5MG

500MG;10MG

650MG;10MG

660MG;10MG

750MG;7.5MG

MIKART

500MG;2.5MG

500MG;5MG

500MG;5MG

500MG;7.5MG

650MG;5MG

650MG;7.5MG

650MG;10MG

MUTUAL PHARM

500MG;5MG

650MG;7.5MG

650MG;10MG

750MG;7.5MG

RANBAXY

500MG;5MG

500MG;10MG

RANBAXY LABS LTD

750MG;7.5MG

SANDOZ

500MG;5MG

750MG;7.5MG

SUN PHARM INDS LTD

325MG;10MG

UCB INC

500MG;10MG

650MG;7.5MG

USL PHARMA

500MG;5MG

500MG;5MG

VINTAGE PHARMS

500MG;2.5MG

500MG;5MG

500MG;5MG

500MG;7.5MG

500MG;10MG

650MG;7.5MG

650MG;10MG

660MG;10MG

750MG;7.5MG

VINTAGE PHARMS LLC

500MG;5MG

500MG;7.5MG

650MG;7.5MG

650MG;10MG

750MG;7.5MG

WATSON LABS

325MG;7.5MG

325MG;10MG

500MG;2.5MG

500MG;2.5MG

500MG;5MG

500MG;5MG

500MG;7.5MG

500MG;7.5MG

650MG;7.5MG

650MG;7.5MG

650MG;10MG

650MG;10MG

660MG;10MG

750MG;7.5MG

750MG;7.5MG

750MG;10MG

WATSON LABS FLORIDA

500MG;5MG

660MG;10MG

750MG;7.5MG

LORTAB

UCB INC

500MG;5MG

500MG;10MG

NORCET

ABANA

500MG;5MG

A090380
A090380
A089554
A089696
A040084
A040201
A040201
A040084
A040084
A040084
A089698
A089271
A089697
A089699
A040849
A089689
A081223
A040236
A040240
A040240
A040236
A040825
A040824
A040822
A040149
A040149
A040826
A040210
A040134
A089290
A089291
A040144
A089831
A089971
A040144
A040356
A040155
A040143
A040358
A040157
A040281
A040280
A040280
A040280
A040281
A040248
A040248
A040123
A081079
A040122
A089883
A040123
A081080
A040094
A040123
A040094
A040123
A040094
A040122
A081083
A040094
A040493
A040495
A040494

003
004
001
001
002
001
002
004
003
001
001
001
001
001
001
001
001
001
002
001
002
001
001
001
001
002
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
002
003
002
001
002
003
001
001
001
004
001
001
001
002
002
003
002
001
004
001
001
001

Dec
Dec
Jun
Apr
Jun
Feb
Feb
Oct
Jul
Jun
Aug
Jul
Jan
Aug
Jun
Jun
May
Sep
Nov
Nov
Sep
Aug
Aug
Aug
Jan
Jan
Aug
Aug
Nov
May
May
Apr
Sep
Dec
Feb
May
Apr
Feb
May
Apr
Sep
Sep
Sep
Sep
Sep
Apr
Apr
Mar
Aug
Mar
Dec
Mar
Aug
Sep
Mar
Sep
Mar
Aug
Mar
Aug
Mar
May
May
May

23,
23,
12,
21,
01,
27,
27,
16,
29,
01,
25,
16,
28,
25,
09,
29,
29,
25,
26,
26,
25,
16,
16,
16,
27,
27,
16,
13,
21,
29,
29,
25,
07,
02,
22,
31,
14,
22,
31,
12,
30,
30,
30,
30,
30,
28,
28,
04,
30,
04,
01,
04,
30,
29,
04,
29,
04,
08,
04,
30,
22,
28,
28,
28,

2008

2008

1987

1988

1995

1998

1998

1996

1996

1995

1989

1986

1992

1989

2010

1988

1992

1997

1997

1997

1997

2007

2007

2007

1997

1997

2007

1997

1996

1987

1987

1997

1988

1988

1996

2000

1997

1996

2000

1996

1998

1998

1998

1998

1998

2000

2000

1996

1991

1996

1988

1996

1991

1995

1996

1995

1996

2000

1996

1991

1999

2003

2003

2003

A087722 001 Jul 09, 1982

A040100 001 Jan 26, 1996

A088871 001 May 15, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-7(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET;ORAL
TYCOLET
ORTHO MCNEIL PHARM
500MG;5MG
VICODIN
ABBOTT
500MG;5MG
ABBVIE
500MG;5MG
VICODIN ES
ABBVIE
750MG;7.5MG
VICODIN HP
ABBVIE
660MG;10MG
ZYDONE
VINTAGE PHARMS LLC
400MG;5MG
400MG;7.5MG
400MG;10MG
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL
OXYCODONE AND ACETAMINOPHEN
ACTAVIS ELIZABETH
500MG;5MG
BARR
500MG;5MG
DURAMED PHARMS BARR
500MG;5MG
HALSEY
500MG;5MG
MALLINCKRODT
500MG;5MG
MUTUAL PHARM
500MG;5MG
VINTAGE PHARMS
500MG;5MG
VINTAGE PHARMS LLC
500MG;5MG
WATSON LABS
500MG;5MG
ROXILOX
ROXANE
500MG;5MG
TYLOX
JANSSEN PHARMS
500MG;5MG
TYLOX-325
ORTHO MCNEIL PHARM
325MG;5MG
SOLUTION;ORAL
OXYCODONE AND ACETAMINOPHEN
MALLINCKRODT INC
325MG/5ML;5MG/5ML
TABLET;ORAL
OXYCODONE 2.5/APAP 500
BRISTOL MYERS SQUIBB
500MG;2.5MG
OXYCODONE 5/APAP 500
BRISTOL MYERS SQUIBB
500MG;5MG
OXYCODONE AND ACETAMINOPHEN
ACTAVIS ELIZABETH
325MG;5MG
325MG;7.5MG
325MG;10MG
AMNEAL PHARMS NY
500MG;7.5MG
650MG;10MG
BARR
325MG;5MG
COASTAL PHARMS
500MG;7.5MG
650MG;10MG
DURAMED PHARMS BARR
325MG;5MG
MALLINCKRODT
500MG;7.5MG
650MG;10MG
MIKART
400MG;2.5MG
400MG;5MG
400MG;7.5MG
400MG;10MG
500MG;10MG
WATSON LABS
500MG;7.5MG
650MG;10MG
PERCOCET
VINTAGE PHARMS LLC
325MG;5MG
500MG;7.5MG
650MG;10MG
ROXICET 5/500
ROXANE
500MG;5MG

A089385 001 Aug 27, 1986

A085667 001
A088058 001 Jan 07, 1983
A089736 001 Dec 09, 1988
A040117 001 Sep 23, 1996
A040288 001 Nov 27, 1998
A040288 002 Nov 27, 1998
A040288 003 Nov 27, 1998

A040199
A040304
A040289
A089994
A040257
A040219
A040106
A040303
A040234

001
001
001
001
001
001
001
001
001

Dec
Oct
Mar
May
Aug
Jan
Jul
Dec
Oct

30,
02,
16,
04,
04,
22,
30,
30,
30,

1998
2000
1999
1989
1998
1998
1996
1999
1997

A040061 001 Jul 03, 1995

A088790 001 Dec 12, 1984
A088246 001 Nov 08, 1984

A040680 001 Sep 29, 2006

A085910 001
A085911 001
A040203
A040800
A040800
A040789
A040789
A087406
A090177
A090177
A040272
A040550
A040550
A040679
A040687
A040698
A040692
A040676
A040371
A040371

001
001
002
001
002
001
005
006
001
001
002
001
001
001
001
001
001
002

Mar
Apr
Apr
Nov
Nov

15,
03,
03,
27,
27,

1999
2012
2012
2007
2007

Oct
Oct
Jun
Jun
Jun
May
Apr
Apr
Apr
Apr
Dec
Dec

20,
20,
30,
30,
30,
16,
27,
27,
27,
19,
29,
29,

2008
2008
1998
2004
2004
2006
2006
2006
2006
2006
2000
2000

A085106 002
A040341 001 Jul 26, 1999
A040341 002 Jul 26, 1999
A089775 001 Jan 12, 1989

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-8(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
CAPSULE;ORAL
TYLOX
ORTHO MCNEIL PHARM
500MG;4.5MG;0.38MG
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
GAVIS PHARMS
650MG;EQ 25MG BASE
WATSON LABS
650MG;EQ 25MG BASE
TALACEN
SANOFI AVENTIS US
650MG;EQ 25MG BASE
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
TABLET;ORAL
DARVOCET
AAIPHARMA LLC
325MG;32.5MG
DOLENE AP-65
LEDERLE
650MG;65MG
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
MYLAN
325MG;32MG
650MG;65MG
SANDOZ
650MG;65MG
VINTAGE PHARMS
650MG;65MG
WATSON LABS
650MG;65MG
WYGESIC
CARACO
650MG;65MG
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
TABLET;ORAL
DARVOCET A500
XANODYNE PHARM
500MG;100MG
DARVOCET-N 100
XANODYNE PHARM
650MG;100MG
DARVOCET-N 50
XANODYNE PHARM
325MG;50MG
PROPACET 100
TEVA
650MG;100MG
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
ABLE
650MG;100MG
ACTAVIS ELIZABETH
650MG;100MG
CORNERSTONE
325MG;100MG
500MG;100MG
HALSEY
325MG;50MG
650MG;100MG
IVAX SUB TEVA PHARMS
650MG;100MG
MALLINCKRODT
650MG;100MG
MIRROR PHARMS
650MG;100MG
MUTUAL PHARM
325MG;50MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
MYLAN
650MG;100MG
MYLAN PHARMS INC
650MG;100MG
SANDOZ
650MG;100MG
SUPERPHARM
650MG;100MG
TEVA
650MG;100MG
650MG;100MG
VINTAGE PHARMS
325MG;50MG
650MG;100MG
WATSON LABS
325MG;50MG
650MG;100MG
WATSON LABS FLORIDA
500MG;100MG
650MG;100MG
WOCKHARDT LTD
325MG;50MG
650MG;100MG

A085375 001

A076202 001 Aug 02, 2002

A074699 001 Mar 24, 2000
N018458 001 Sep 23, 1982

N016844 001
A085100 001
A083689
A083978
A089959
A040507
A040139

001
001
001 Jul 18, 1989
001 Jul 30, 2003
001 Dec 16, 1996

A084999 001

A076429 001 Sep 10, 2003

N017122 002
N017122 001
A070107 001 Jun 12, 1985
A075838
A070910
A076743
A076750
A072105
A072106
A070146
A075738
A077821
A070115
A070116
A070615
A070771
A070775
A072195
A070145
A070443
A071319
A070732
A074119
A074843
A074843
A070398
A070399
A077196
A076609
A077677
A077677

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
002

Jul
Jan
May
Jun
May
May
Aug
Feb
Feb
Jun
Jun
Mar
Mar
Mar
Feb
Jun
Jan
Jan
Jan
Dec
Feb
Feb
Dec
Dec
Jun
Nov
Mar
Mar

11,
02,
07,
28,
13,
13,
02,
02,
11,
12,
12,
21,
21,
21,
16,
12,
23,
06,
03,
19,
15,
12,
18,
18,
28,
16,
16,
16,

2001
1987
2004
2004
1988
1988
1985
2001
2008
1985
1985
1986
1986
1986
1988
1985
1986
1987
1986
1994
2001
1997
1986
1986
2005
2004
2007
2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-9(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
WATSON LABS
325MG;37.5MG
ACETAZOLAMIDE
TABLET;ORAL
ACETAZOLAMIDE
ALRA
ASCOT
SUN PHARM INDS
VANGARD
WATSON LABS
DIAMOX
TEVA BRANDED PHARM

ACETAZOLAMIDE SODIUM
INJECTABLE;INJECTION
ACETAZOLAMIDE SODIUM
HOSPIRA
DIAMOX
TEVA WOMENS

ACETIC ACID, GLACIAL

SOLUTION/DROPS;OTIC
ACETASOL
ACTAVIS MID ATLANTIC
ACETIC ACID
KV PHARM
ORLEX
WARNER CHILCOTT

A076914 001 Jul 26, 2006

250MG
250MG
250MG
250MG
250MG
250MG

A083320
A087686
A089753
A087654
A084498
A088882

001
001
001
001
002
001

125MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**
250MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N008943 001

EQ 500MG BASE/VIAL

A040108 001 Oct 30, 1995

EQ 500MG BASE/VIAL **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N009388 001 Dec 05, 1990

2%

A087146 001

2%

A085493 001

2%

A086845 001

A084476 001

ACETIC ACID, GLACIAL; DESONIDE

SOLUTION/DROPS;OTIC
TRIDESILON
BAYER PHARMS
2%;0.05%

N017914 001

A088606 001 Aug 21, 1985

ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS;OTIC
ACETIC ACID W/ HYDROCORTISONE
KV PHARM
2%;1%
HYDROCORTISONE AND ACETIC ACID
BAUSCH AND LOMB
2%;1%
WOCKHARDT
2%;1%
ORLEX HC
WARNER CHILCOTT
2%;1%

A086844 001

ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE

SUSPENSION/DROPS;OTIC
NEO-CORT-DOME
BAYER PHARMS
2%;1%;EQ 0.35% BASE

N050238 001

USL PHARMA
WATSON LABS

250MG
500MG
250MG
500MG
250MG

Oct 22, 1985

N008943 002

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

SOLUTION/DROPS;OTIC
BOROFAIR
PHARMAFAIR
2%;0.79%
DOMEBORO
BAYER PHARMS
2%;0.79%

ACETOHEXAMIDE
TABLET;ORAL
ACETOHEXAMIDE
ANI PHARMS INC

Oct 20, 1982

Jun 22, 1988
Feb 05, 1982

A085492 001
A040097 001 Oct 31, 1994
A040168 001 Aug 30, 1996

A070869
A070870
A070753
A070754
A071893

001
001
001
001
001

Feb
Feb
Nov
Nov
Nov

09,
09,
03,
03,
25,

1987
1987
1986
1986
1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-10(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACETOHEXAMIDE

TABLET;ORAL

ACETOHEXAMIDE

500MG

A071894 001 Nov 25, 1987

250MG

500MG

N013378 002

N013378 001

ACETOPHENAZINE MALEATE

TABLET;ORAL

TINDAL

SCHERING

20MG

N012254 002

ACETRIZOATE SODIUM

SOLUTION;INTRAUTERINE

SALPIX

ORTHO MCNEIL PHARM

53%

N009008 001

ACETYLCHOLINE CHLORIDE

FOR SOLUTION;OPHTHALMIC

MIOCHOL

NOVARTIS

20MG/VIAL

N016211 001

10%

20%

10%

10%

20%

20%

A071364
A071365
A072323
A072621
A072324
A072622

10%

20%

N013601 002

N013601 001

10%

A070575 001 Oct 14, 1986

20%

A070576 001 Oct 14, 1986

DYMELOR

LILLY

ACETYLCYSTEINE

SOLUTION;INHALATION, ORAL

ACETYLCYSTEINE

HOSPIRA

ROXANE

MUCOMYST

APOTHECON

MUCOSIL-10

DEY

MUCOSIL-20

DEY

001
001
001
001
001
001

May
May
Apr
Sep
Apr
Sep

01,
01,
30,
30,
30,
30,

1989

1989

1992

1992

1992

1992

ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE

SOLUTION;INHALATION

MUCOMYST W/ ISOPROTERENOL

MEAD JOHNSON

10%;0.05%

N017366 001

ACETYLDIGITOXIN

TABLET;ORAL

ACYLANID

NOVARTIS

0.1MG

N009436 001

ACRISORCIN

CREAM;TOPICAL

AKRINOL

SCHERING

2MG/GM

N012470 001

200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG

A074906
A074872
A074889
A074674
A074750
A074977
A074570
A074828
A074914
A075101

001
001
001
001
001
001
002
001
001
001

Aug
Apr
Oct
Apr
Apr
Apr
Apr
Apr
Nov
Apr

26,
22,
31,
22,
22,
13,
22,
22,
26,
15,

1997
1997
1997
1997
1997
1998
1997
1997
1997
1998

400MG
800MG
400MG
800MG
400MG
800MG

A074870
A074870
A074834
A074834
A074891
A074891

001
002
001
002
001
002

Jun
Jun
Apr
Apr
Oct
Oct

05,
05,
24,
24,
31,
31,

1997
1997
1997
1997
1997
1997

ACYCLOVIR

CAPSULE;ORAL

ACYCLOVIR

ACTAVIS ELIZABETH

DAVA PHARMS INC

HERITAGE PHARMS INC

IVAX SUB TEVA PHARMS

LEK PHARM

MYLAN

ROXANE

TEVA

TEVA PHARMS

WATSON LABS

TABLET;ORAL

ACYCLOVIR

ACTAVIS ELIZABETH

DAVA PHARMS INC

HERITAGE PHARMS INC

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-11(of 347)

DISCONTINUED DRUG PRODUCT LIST

ACYCLOVIR
TABLET;ORAL
ACYCLOVIR
IVAX SUB TEVA PHARMS
LEK PHARM
MYLAN
TEVA

TEVA PHARMS
ACYCLOVIR SODIUM
INJECTABLE;INJECTION
ACYCLOVIR
ABBVIE
ACYCLOVIR SODIUM
APOTHECON
HIKMA MAPLE
HOSPIRA

TEVA PARENTERAL

ZOVIRAX
GLAXOSMITHKLINE

ADAPALENE
SOLUTION;TOPICAL
DIFFERIN
GALDERMA LABS LP
ADENOSINE
INJECTABLE;INJECTION
ADENOSINE
EUROHLTH INTL SARL
TEVA PHARMS USA
WOCKHARDT
ALATROFLOXACIN MESYLATE
INJECTABLE;INJECTION
TROVAN PRESERVATIVE FREE
PFIZER
ALBENDAZOLE
TABLET, CHEWABLE;ORAL
ALBENZA
AMEDRA PHARMS LLC

400MG
800MG
400MG
800MG
400MG
800MG
200MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
400MG
800MG

A075021 001 Mar 18, 1998

A075021 002 Mar 18, 1998

EQ 50MG BASE/ML

A075114 001 Jul 26, 1999

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A074897
A074897
A074913
A074913
A074720
A075065
A074663
A074758
A074663
A074758
A075627
A074969
A074969

500MG BASE/VIAL
1GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
25MG BASE/ML
50MG BASE/ML
500MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
50MG BASE/ML
500MG BASE/VIAL
1GM BASE/VIAL

A074836
A074836
A074658
A074658
A074976
A074976
A074556

001
002
001
002
001
002
001

001
002
001
002
001
001
001
001
002
002
001
001
002

Apr
Apr
Apr
Apr
Apr
Apr
Apr

Feb
Feb
Oct
Oct
Apr
Feb
Apr
Apr
Apr
Apr
Mar
Aug
Aug

22,
22,
22,
22,
13,
13,
22,

27,
27,
15,
15,
22,
25,
22,
22,
22,
22,
28,
26,
26,

1997
1997
1997
1997
1998
1998
1997

1998
1998
1997
1997
1997
1999
1997
1997
1997
1997
2001
1997
1997

EQ 250MG BASE/VIAL **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 500MG BASE/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 1GM BASE/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N018603 003 Aug 30, 1983

0.1%

N020338 001 May 31, 1996

3MG/ML
3MG/ML
3MG/ML
3MG/ML

A076501
A076564
A078676
A090220

EQ 200MG BASE/VIAL
EQ 300MG BASE/VIAL

N020760 001 Dec 18, 1997

N020760 002 Dec 18, 1997

200MG

N207844 001 Jun 11, 2015

N018603 001 Oct 22, 1982

N018603 002 Jun 29, 1989

001
001
001
001

Jun
Jun
Jul
Jul

16,
16,
31,
20,

2004
2004
2008
2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-12(of 347)

DISCONTINUED DRUG PRODUCT LIST

ALBUMIN CHROMATED CR-51 SERUM
INJECTABLE;INJECTION
CHROMALBIN
ISO TEX

100uCi/VIAL
250uCi/VIAL
500uCi/VIAL

ALBUMIN IODINATED I-125 SERUM

INJECTABLE;INJECTION
RADIO-IODINATED (I 125) SERUM ALBUMIN (HUMAN)
BAYER PHARMS
2.5uCi/AMP
RADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 125
MALLINCKRODT
6.67uCi/ML
10uCi/ML
100uCi/ML
ALBUMIN IODINATED I-131 SERUM
INJECTABLE;INJECTION
MEGATOPE
ISO TEX

ALBUTEROL
AEROSOL, METERED;INHALATION
ALBUTEROL
ARMSTRONG PHARMS
GENPHARM
IVAX SUB TEVA PHARMS
PLIVA
PROVENTIL
SCHERING
VENTOLIN
GLAXOSMITHKLINE
ALBUTEROL SULFATE
CAPSULE;INHALATION
VENTOLIN ROTACAPS
GLAXOSMITHKLINE
SOLUTION;INHALATION
ALBUTEROL SULFATE
ACTAVIS MID ATLANTIC
APOTEX INC

BAUSCH AND LOMB

COPLEY PHARM
ROXANE
WOCKHARDT EU OPERATN
PROVENTIL
SCHERING
VENTOLIN
GLAXOSMITHKLINE
SYRUP;ORAL
ALBUTEROL SULFATE
ACTAVIS MID ATLANTIC
MOVA
WATSON LABS
PROVENTIL
SCHERING
VENTOLIN
GLAXOSMITHKLINE
TABLET;ORAL
ALBUTEROL SULFATE
AM THERAP
COPLEY PHARM
DAVA PHARMS INC

N017835 001
N017835 002
N017835 003

N017846 001
N017844 003
N017844 001
N017844 002

2mCi/VIAL
5uCi/AMP
20uCi/AMP

N017837 003
N017837 004
N017837 005

0.09MG/INH
0.09MG/INH
0.09MG/INH
0.09MG/INH

A072273
A073045
A073272
A074072

0.09MG/INH

N017559 001

0.09MG/INH

N018473 001

EQ 0.2MG BASE

N019489 001 May 04, 1988

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A073533
A078623
A078623
A075717
A076391
A075358
A073495
A073307
A075129
A075394

0.083% BASE
0.021% BASE
0.042% BASE
0.083% BASE
0.5% BASE
0.083% BASE
0.083% BASE
0.5% BASE
0.083% BASE
0.083% BASE

001
001
001
001

001
001
002
001
001
001
001
001
001
001

Aug
Aug
Dec
Aug

Sep
Apr
Apr
Feb
Apr
Mar
May
Nov
Feb
Nov

14,
19,
28,
01,

26,
05,
05,
02,
01,
29,
28,
27,
13,
22,

1996
1997
1995
1996

1995
2010
2010
2007
2003
2000
1993
1991
2001
1999

EQ 0.083% BASE
EQ 0.5% BASE

N019243 002 Jan 14, 1987

N019243 001 Jan 14, 1987

EQ 0.083% BASE
EQ 0.5% BASE

N019773 001 Apr 23, 1992

N019269 002 Jan 16, 1987

EQ 2MG BASE/5ML
EQ 2MG BASE/5ML
EQ 2MG BASE/5ML

A075262 001 Mar 30, 1999

A074302 001 Sep 30, 1994
A073165 001 Apr 29, 1993

EQ 2MG BASE/5ML

N018062 001 Jan 19, 1983

EQ 2MG BASE/5ML

N019621 001 Jun 10, 1987

EQ
EQ
EQ
EQ
EQ
EQ

A072449
A072450
A072966
A072967
A072859
A072860

2MG
4MG
2MG
4MG
2MG
4MG

BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001

Dec
Dec
Nov
Nov
Dec
Dec

05,
05,
22,
22,
20,
20,

1989
1989
1991
1991
1989
1989

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-13(of 347)

DISCONTINUED DRUG PRODUCT LIST

ALBUTEROL SULFATE
TABLET;ORAL
ALBUTEROL SULFATE
PLIVA
SANDOZ
TEVA

UCB INC
WARNER CHILCOTT
WATSON LABS

PROVENTIL
SCHERING
VENTOLIN
GLAXOSMITHKLINE

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2MG
4MG
2MG
4MG
2MG
2MG
2MG
4MG
4MG
4MG
2MG
4MG
2MG
4MG
2MG
2MG
4MG
4MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A072316
A072317
A072151
A072152
A072619
A072779
A072938
A072620
A072780
A072939
A073120
A073121
A072817
A072818
A072629
A072764
A072630
A072765

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Dec
Dec
Dec
Dec
Dec
Jun
Mar
Dec
Jun
Mar
Sep
Sep
Jan
Jan
Jan
Aug
Jan
Aug

05,
05,
05,
05,
05,
25,
30,
05,
25,
30,
29,
29,
09,
09,
31,
28,
31,
28,

1989
1989
1989
1989
1989
1993
1990
1989
1993
1990
1992
1992
1990
1990
1991
1991
1991
1991

EQ 2MG BASE
EQ 4MG BASE

N017853 001 May 07, 1982

N017853 002 May 07, 1982

EQ 2MG BASE
EQ 4MG BASE

N019112 001 Jul 10, 1986

N019112 002 Jul 10, 1986

TABLET, EXTENDED RELEASE;ORAL

PROVENTIL
SCHERING
EQ 4MG BASE
VOLMAX
MURO
EQ 4MG BASE
EQ 8MG BASE

N019383 001 Jul 13, 1987

N019604 002 Dec 23, 1992
N019604 001 Dec 23, 1992

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

AEROSOL, METERED;INHALATION
COMBIVENT
BOEHRINGER INGELHEIM
EQ 0.09MG BASE/INH;0.018MG/INH
SOLUTION;INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
APOTEX INC
EQ 0.083% BASE;0.017%
SANDOZ INC
EQ 0.083% BASE;0.017%

A077117 001 Dec 31, 2007

A076867 001 Dec 21, 2006

ALCLOMETASONE DIPROPIONATE
CREAM;TOPICAL
ACLOVATE
FOUGERA PHARMS

0.05% **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N018707 001 Dec 14, 1982

0.05% **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N018702 001 Dec 14, 1982

5ML/100ML

A083483 001

OINTMENT;TOPICAL
ACLOVATE
FOUGERA PHARMS

ALCOHOL
INJECTABLE;INJECTION
ALCOHOL 5% IN DEXTROSE 5%
MILES

ALCOHOL; DEXTROSE
INJECTABLE;INJECTION
ALCOHOL 10% AND DEXTROSE 5%
B BRAUN
10ML/100ML;5GM/100ML
ALCOHOL 5% AND DEXTROSE 5%
B BRAUN
5ML/100ML;5GM/100ML
ALCOHOL 5% IN D5-W
HOSPIRA
5ML/100ML;5GM/100ML
ALCOHOL 5% IN DEXTROSE 5% IN WATER
BAXTER HLTHCARE
5ML/100ML;5GM/100ML

N020291 001 Oct 24, 1996

N004589 006
N004589 004
A083263 001
A083256 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-14(of 347)

DISCONTINUED DRUG PRODUCT LIST

ALENDRONATE SODIUM
TABLET;ORAL
ALENDRONATE SODIUM
MYLAN
SANDOZ

TEVA PHARMS
FOSAMAX
MERCK AND CO INC

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

35MG BASE
70MG BASE
5MG BASE
10MG BASE
35MG BASE
40MG BASE
70MG BASE
35MG BASE
70MG BASE

A078638
A078638
A075871
A075871
A075871
A075871
A075871
A076184
A076184

EQ 5MG BASE **Federal Register

determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
EQ 10MG BASE **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
EQ 35MG BASE **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
EQ 40MG BASE **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**

ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALFUZOSIN HYDROCHLORIDE
WOCKHARDT LTD
10MG
ALGLUCERASE
INJECTABLE;INJECTION
CEREDASE
GENZYME

Aug
Aug
Apr
Apr
Apr
Apr
Apr
Aug
Feb

04,
04,
22,
22,
22,
22,
22,
04,
06,

2008
2008
2009
2009
2009
2009
2009
2008
2008

N020560 003 Apr 25, 1997

or
N020560 001 Sep 29, 1995
or
N020560 004 Oct 20, 2000
or
N020560 002 Sep 29, 1995
or

A090221 001 Aug 10, 2012

10 UNITS/ML
80 UNITS/ML

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

TABLET;ORAL
TEKAMLO
NOVARTIS
EQ 150MG BASE;EQ
EQ 150MG BASE;EQ
EQ 300MG BASE;EQ
EQ 300MG BASE;EQ

001
002
001
002
004
003
005
002
001

N020057 004 May 08, 1992

N020057 003 Apr 05, 1991

N022545
N022545
N022545
N022545

001
002
003
004

Aug
Aug
Aug
Aug

26,
26,
26,
26,

2010
2010
2010
2010

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL
AMTURNIDE
NOVARTIS
EQ 150MG BASE;EQ 5MG BASE;12.5MG
EQ 300MG BASE;EQ 5MG BASE;12.5MG
EQ 300MG BASE;EQ 5MG BASE;25MG
EQ 300MG BASE;EQ 10MG BASE;12.5MG
EQ 300MG BASE;EQ 10MG BASE;25MG

N200045
N200045
N200045
N200045
N200045

001
002
003
004
005

Dec
Dec
Dec
Dec
Dec

21,
21,
21,
21,
21,

2010
2010
2010
2010
2010

ALISKIREN HEMIFUMARATE; VALSARTAN

TABLET;ORAL
VALTURNA
NOVARTIS
EQ 150MG BASE;160MG
EQ 300MG BASE;320MG

N022217 001 Sep 16, 2009

N022217 002 Sep 16, 2009

ALKAVERVIR
TABLET;ORAL
VERILOID
3M
ALLOPURINOL
TABLET;ORAL
ALLOPURINOL
MUTUAL PHARM
PURACAP PHARM

5MG BASE
10MG BASE
5MG BASE
10MG BASE

2MG
3MG

N007336 002
N007336 003

100MG
300MG
100MG
300MG

A070466
A070467
A070150
A070147

001
001
001
001

Dec
Dec
Dec
Dec

24,
24,
10,
10,

1985
1985
1985
1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-15(of 347)

DISCONTINUED DRUG PRODUCT LIST

ALLOPURINOL
TABLET;ORAL
ALLOPURINOL
PUREPAC PHARM
SANDOZ
SUPERPHARM
WATSON LABS

LOPURIN
ABBOTT
ALPRAZOLAM
SOLUTION;ORAL
ALPRAZOLAM
ROXANE
TABLET;ORAL
ALPRAZOLAM
ANI PHARMS INC

IVAX SUB TEVA PHARMS

ROXANE

WATSON LABS

100MG
300MG
100MG
300MG
100MG
300MG
100MG
100MG
300MG
300MG

A070579
A070580
A070268
A070269
A070950
A070951
N018241
N018785
N018241
N018785

100MG
300MG

N018297 001
N018297 002

0.5MG/5ML

A074314 001 Oct 31, 1993

0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
0.25MG
0.25MG
0.5MG
0.5MG
1MG
1MG

A074085
A074085
A074085
A074085
A074294
A074294
A074294
A074294
A074199
A074199
A074199
A074456
A074479
A074456
A074479
A074456
A074479

001
002
003
004
001
002
003
004
001
002
003
001
001
002
002
003
003

Feb
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Aug
Jan
Aug
Jan
Aug
Jan

16,
16,
16,
26,
29,
29,
29,
29,
19,
19,
19,
31,
21,
31,
21,
31,
21,

1994
1994
1994
1996
1994
1994
1994
1994
1993
1993
1993
1995
1997
1995
1997
1995
1997

A077979
A077979
A077979
A077979
A077777
A077777
A077777
A077777
A078442
A078442
A078442
A078442

001
002
003
004
001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct

28,
28,
28,
28,
30,
30,
30,
30,
15,
15,
15,
15,

2007
2007
2007
2007
2006
2006
2006
2006
2007
2007
2007
2007

TABLET, EXTENDED RELEASE;ORAL

ALPRAZOLAM
ANI PHARMS INC
0.5MG
1MG
2MG
3MG
SANDOZ INC
0.5MG
1MG
2MG
3MG
VINTAGE PHARMS
0.5MG
1MG
2MG
3MG
TABLET, ORALLY DISINTEGRATING;ORAL
NIRAVAM
UCB INC
0.25MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.5MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
1MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**

001
001
001
001
001
001
001
001
002
002

Apr
Apr
Dec
Dec
Nov
Nov
Nov
Sep
Nov
Sep

14,
14,
31,
31,
30,
30,
16,
28,
16,
28,

1986
1986
1985
1985
1988
1988
1984
1984
1984
1984

N021726 001 Jan 19, 2005

N021726 002 Jan 19, 2005

N021726 003 Jan 19, 2005

N021726 004 Jan 19, 2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-16(of 347)

DISCONTINUED DRUG PRODUCT LIST

ALPROSTADIL

INJECTABLE;INJECTION

CAVERJECT

PFIZER

0.005MG/ML
0.01MG/ML
0.02MG/ML

N020755 001 Oct 31, 1997

N020755 002 Oct 01, 1997
N020755 003 Oct 01, 1997

0.005MG/VIAL

N020649 001 Jun 12, 1997

2MG

N009215 001

2MG

N008867 001

EDEX

AUXILIUM PHARMS LLC

ALSEROXYLON

TABLET;ORAL

RAUTENSIN

NOVARTIS

RAUWILOID

3M

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

TABLET, CHEWABLE;ORAL

ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE

PENNEX

80MG;20MG

FOAMICON

NOVARTIS

80MG;20MG

AMANTADINE HYDROCHLORIDE

CAPSULE;ORAL

AMANTADINE HYDROCHLORIDE

ACTAVIS ELIZABETH

WATSON LABS

SYMADINE

SOLVAY

SYMMETREL

ENDO PHARMS

SYRUP;ORAL

AMANTADINE HYDROCHLORIDE

G AND W LABS INC

SILARX

TEVA PHARMS

VINTAGE

SYMMETREL

ENDO PHARMS

TABLET;ORAL

SYMMETREL

ENDO PHARMS

AMBENONIUM CHLORIDE

TABLET;ORAL

MYTELASE

SANOFI AVENTIS US

AMCINONIDE

CREAM;TOPICAL

CYCLOCORT

ASTELLAS

LOTION;TOPICAL

CYCLOCORT

ASTELLAS

OINTMENT;TOPICAL

CYCLOCORT

ASTELLAS

AMDINOCILLIN

INJECTABLE;INJECTION

COACTIN

ROCHE

AMIFOSTINE

INJECTABLE;INJECTION

ETHYOL

CLINIGEN HLTHCARE

A089449 001 Nov 27, 1987

A072687 001 Jun 28, 1989

100MG

100MG

A077659 001 Feb 23, 2006

A071382 001 Jan 21, 1987

100MG

A071000 001 Sep 04, 1986

100MG

N016020 001

50MG/5ML

50MG/5ML

50MG/5ML

50MG/5ML

A072655
A076352
A073115
A077992

50MG/5ML

N016023 002

100MG

N018101 001

10MG

N010155 002

0.025%

0.1%

N018116 001

N018116 002

0.1%

N019729 001 Jun 13, 1988

0.1%

N018498 001

250MG/VIAL

500MG/VIAL

1GM/VIAL

N050565 001 Dec 21, 1984

N050565 002 Dec 21, 1984

N050565 003 Dec 21, 1984

375MG/VIAL

N020221 002 Sep 10, 1999

001
001
001
001

Oct
Sep
Aug
Dec

30,
10,
23,
12,

1990

2004

1991

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-17(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMIKACIN SULFATE
INJECTABLE;INJECTION
AMIKACIN SULFATE
ABBOTT

EQ 250MG BASE/ML
EQ 250MG BASE/ML
HIKMA MAPLE
EQ 50MG BASE/ML
EQ 250MG BASE/ML
HOSPIRA
EQ 50MG BASE/ML
EQ 50MG BASE/ML
EQ 62.5MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
IGI LABS INC
EQ 50MG BASE/ML
EQ 250MG BASE/ML
TEVA PHARMS USA
EQ 50MG BASE/ML
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
EQ 500MG BASE/100ML
AMIKIN
APOTHECON
EQ 50MG BASE/ML
EQ 50MG BASE/ML
EQ 50MG BASE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
APOTHECON
EQ 5MG BASE/ML
EQ 10MG BASE/ML

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SANDOZ
EQ 5MG ANHYDROUS;50MG
TEVA
EQ 5MG ANHYDROUS;50MG
WATSON LABS
EQ 5MG ANHYDROUS;50MG
HYDRO-RIDE
PAR PHARM
EQ 5MG ANHYDROUS;50MG
MODURETIC 5-50
MERCK
EQ 5MG ANHYDROUS;50MG
AMINO ACIDS
INJECTABLE;INJECTION
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
HOSPIRA
5.2% (5.2GM/100ML)
AMINOSYN 3.5% IN PLASTIC CONTAINER
ABBOTT
3.5% (3.5GM/100ML)
3.5% (3.5GM/100ML)
AMINOSYN II 3.5%
HOSPIRA
3.5% (3.5GM/100ML)
AMINOSYN II 3.5% IN PLASTIC CONTAINER
ABBOTT
3.5% (3.5GM/100ML)
AMINOSYN II 5%
HOSPIRA
5% (5GM/100ML)
AMINOSYN-HBC 7% IN PLASTIC CONTAINER
ABBOTT
7% (7GM/100ML)
BRANCHAMIN 4%
BAXTER HLTHCARE
4% (4GM/100ML)
BRANCHAMIN 4% IN PLASTIC CONTAINER
BAXTER HLTHCARE
4% (4GM/100ML)
FREAMINE 8.5%
B BRAUN
8.5% (8.5GM/100ML)
FREAMINE II 8.5%
B BRAUN
8.5% (8.5GM/100ML)
HEPATASOL 8%
BAXTER HLTHCARE
8% (8GM/100ML)
NEOPHAM 6.4%
HOSPIRA
6.4% (6.4GM/100ML)

A063265
A063266
A063274
A063275
A063263
A063350
A063283
A063264
A063350
A064098
A064099
A063167
A063169
A064045

001
001
001
001
001
001
001
001
002
001
001
001
001
001

Nov
Oct
May
May
Nov
Jul
Oct
Nov
Jul
Jun
Jun
Dec
Dec
Sep

30,
31,
18,
18,
30,
30,
31,
30,
30,
26,
20,
14,
14,
28,

1994
1994
1992
1992
1994
1993
1994
1994
1993
1995
1995
1995
1995
1993

A064146 001 Apr 02, 1997

A062311 001
A062562 001 Sep 20, 1984
N050495 001

A062311 002
A062562 002 Sep 20, 1984
N050495 002

N050618 002 Nov 30, 1987

N050618 001 Nov 30, 1987

A073357 001 Nov 27, 1991

A070795 001 Apr 17, 1988
A073334 001 Jul 19, 1991
A070347 001 Dec 25, 1990
N018201 001

N018901 001 Apr 06, 1984

N018804 001 May 15, 1984
N018875 001 Aug 08, 1984
N019438 001 Apr 03, 1986
N019491 001 Oct 10, 1986
N019438 002 Apr 03, 1986
N019400 001 Jul 23, 1986
N018678 001 Sep 28, 1984
N018684 001 Sep 28, 1984
N016822 001
N016822 002
A020360 001 Apr 04, 1996
N018792 001 Jan 17, 1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-18(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMINO ACIDS

INJECTABLE;INJECTION

NOVAMINE 11.4%

HOSPIRA INC
11.4% (11.4GM/100ML)

NOVAMINE 15%

HOSPIRA INC
15% (75GM/500ML)

NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER

BAXTER HLTHCARE
15% (15GM/100ML)

NOVAMINE 8.5%

HOSPIRA INC
8.5% (8.5GM/100ML)

RENAMIN W/O ELECTROLYTES

BAXTER HLTHCARE
6.5% (6.5GM/100ML)

TRAVASOL 10% W/O ELECTROLYTES

BAXTER HLTHCARE
10% (10GM/100ML)

TRAVASOL 5.5% W/O ELECTROLYTES

BAXTER HLTHCARE
5.5% (5.5GM/100ML)

TRAVASOL 8.5% W/O ELECTROLYTES

BAXTER HLTHCARE
8.5% (8.5GM/100ML)

N017957 003 Aug 09, 1982

N017957 004 Nov 28, 1986

N020107 001 Feb 05, 1993

N017957 002 Aug 09, 1982

N017493 007 Oct 15, 1982

N017493 006

N017493 004

N017493 005

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM

PHOSPHATE, DIBASIC; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

ABBOTT
3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML
N019714 001
Sep 12, 1988

;22.4MG/100ML;261MG/100ML;205MG/100ML

HOSPIRA INC

3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML
;22.4MG/100ML;261MG/100ML;205MG/100ML

N019683 001
Nov 07, 1988

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER

ABBOTT
4.25%;36.8MG/100ML;20GM/100ML;51MG/100M
N019714 002
Sep 12, 1988

L;22.4MG/100ML;261MG/100ML;205MG/100ML

HOSPIRA INC

4.25%;36.8MG/100ML;20GM/100ML;51MG/100M
L;22.4MG/100ML;261MG/100ML;205MG/100ML

N019683 002
Nov 07, 1988

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

ABBOTT
4.25%;36.8MG/100ML;25GM/100ML;51MG/100M
N019714 004
Sep 12, 1988

L;22.4MG/100ML;261MG/100ML;205MG/100ML

HOSPIRA INC

4.25%;36.8MG/100ML;25GM/100ML;51MG/100M
L;22.4MG/100ML;261MG/100ML;205MG/100ML

N019683 003
Nov 07, 1988

AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

ABBOTT
5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2
N019714 003
Sep 12, 1988

2.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC
5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2
N019683 004
Nov 07, 1988

2.4MG/100ML;261MG/100ML;205MG/100ML
AMINO ACIDS; DEXTROSE
INJECTABLE;INJECTION
AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT
3.5%;25GM/100ML

AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT
3.5%;5GM/100ML

AMINOSYN 4.25% W/ DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT
4.25%;25GM/100ML

AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT
3.5%;25GM/100ML

3.5%;25GM/100ML

HOSPIRA
3.5%;25GM/100ML

AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT
3.5%;5GM/100ML

3.5%;5GM/100ML

HOSPIRA
3.5%;5GM/100ML

AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER

ABBOTT
4.25%;10GM/100ML

HOSPIRA
4.25%;10GM/100ML

AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

ABBOTT
4.25%;20GM/100ML

HOSPIRA
4.25%;20GM/100ML

AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT
4.25%;25GM/100ML

4.25%;25GM/100ML

HOSPIRA
4.25%;25GM/100ML

N019118 001
Oct 11, 1984

N019120 001
Oct 11, 1984

N019119 001
Oct 11, 1984

N019505 002
Nov 07, 1986

N019713 006
Sep 09, 1988

N019681 001
Nov 01, 1988

N019506 001
Nov 07, 1986

N019713 002
Sep 09, 1988

N019681 002
Nov 01, 1988

N019713 001
Sep 09, 1988

N019681 004
Nov 01, 1988

N019713 004
Sep 09, 1988

N019681 005
Nov 01, 1988

N019504 002
Nov 07, 1986

N019713 005
Sep 09, 1988

N019681 003
Nov 01, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

AMINO ACIDS; DEXTROSE

INJECTABLE;INJECTION

AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT
5%;25GM/100ML

5%;25GM/100ML

HOSPIRA
5%;25GM/100ML

TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;10GM/100ML

TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;15GM/100ML

TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;20GM/100ML

TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;25GM/100ML

TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;5GM/100ML

TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;10GM/100ML

TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;15GM/100ML

TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;20GM/100ML

TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;25GM/100ML

TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;5GM/100ML

6-19(of 347)

N019565 001
Dec 17, 1986

N019713 003
Sep 09, 1988

N019681 006
Nov 01, 1988

N019520 002
Sep 23, 1988

N019520 003
Sep 23, 1988

N019520 004
Sep 23, 1988

N019520 005
Sep 23, 1988

N019520 001
Sep 23, 1988

N019520 007
Sep 23, 1988

N019520 008
Sep 23, 1988

N019520 009
Sep 23, 1988

N019520 010
Sep 23, 1988

N019520 006
Sep 23, 1988

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM

PHOSPHATE, DIBASIC; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER

ABBOTT
4.25%;10GM/100ML;51MG/100ML;176.5MG/100
N019712 002 Sep 08, 1988

ML;22.4MG/100ML;104.5MG/100ML;205MG/100

ML

HOSPIRA INC
4.25%;10GM/100ML;51MG/100ML;176.5MG/100
N019682 003 Nov 01, 1988

ML;22.4MG/100ML;104.5MG/100ML;205MG/100

ML

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;

SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT
3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML
N019564 002 Dec 16, 1986

;261MG/100ML;205MG/100ML

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT
4.25%;25GM/100ML;51MG/100ML;22.4MG/100M
N019564 004 Dec 16, 1986

L;261MG/100ML;205MG/100ML

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE,

DIBASIC, HEPTAHYDRATE

INJECTABLE;INJECTION

AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT
3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12

N019564 001 Dec 16, 1986

0MG/100ML;49.3MG/100ML

3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12

N019712 001 Sep 08, 1988

0MG/100ML;49.3MG/100ML

HOSPIRA INC
3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12

N019682 001 Nov 01, 1988

0MG/100ML;49.3MG/100ML

AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER

ABBOTT
4.25%;10GM/100ML;30MG/100ML;97MG/100ML;

N019564 003 Dec 16, 1986

120MG/100ML;49.3MG/100ML

HOSPIRA INC
4.25%;5GM/100ML;30MG/100ML;97MG/100ML;1

N019682 002 Nov 01, 1988

20MG/100ML;49.3MG/100ML

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM

CHLORIDE

INJECTABLE;INJECTION

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;10GM/100ML;51MG/100ML;261MG/100ML
N020147 002
Oct 23, 1995

;216MG/100ML;112MG/100ML

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;15GM/100ML;51MG/100ML;261MG/100ML
N020147 003
Oct 23, 1995

;216MG/100ML;112MG/100ML

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;20GM/100ML;51MG/100ML;261MG/100ML
N020147 004
Oct 23, 1995

;216MG/100ML;112MG/100ML

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-20(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM

CHLORIDE

INJECTABLE;INJECTION

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;25GM/100ML;51MG/100ML;261MG/100ML
N020147 005
Oct 23, 1995

;216MG/100ML;112MG/100ML

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2.75%;5GM/100ML;51MG/100ML;261MG/100ML;
N020147 001
Oct 23, 1995

216MG/100ML;112MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;10GM/100ML;51MG/100ML;261MG/100ML
N020147 007
Oct 23, 1995

;297MG/100ML;77MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;15GM/100ML;51MG/100ML;261MG/100ML
N020147 008
Oct 23, 1995

;297MG/100ML;77MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;20GM/100ML;51MG/100ML;261MG/100ML
N020147 009
Oct 23, 1995

;297MG/100ML;77MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;25GM/100ML;51MG/100ML;261MG/100ML
N020147 010
Oct 23, 1995

;297MG/100ML;77MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4.25%;5GM/100ML;51MG/100ML;261MG/100ML;
N020147 006
Oct 23, 1995

297MG/100ML;77MG/100ML

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN 3.5% M IN PLASTIC CONTAINER

ABBOTT
3.5%;21MG/100ML;40MG/100ML;128MG/100ML;
N018804 002
May 15, 1984

234MG/100ML

3.5%;21MG/100ML;40MG/100ML;128MG/100ML;
N018875 002
Aug 08, 1984

234MG/100ML

AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN 3.5% M

HOSPIRA
3.5%;21MG/100ML;128MG/100ML;234MG/100ML

N017789 005

AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,

HEPTAHYDRATE

INJECTABLE;INJECTION

AMINOSYN II 3.5% M IN PLASTIC CONTAINER

ABBOTT
3.5%;32MG/100ML;128MG/100ML;222MG/100ML
N019493 001 Oct 16, 1986

;49MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

INJECTABLE;INJECTION

VEINAMINE 8%

HOSPIRA INC
8%;61MG/100ML;211MG/100ML;56MG/100ML;38
N017957 001

8MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN II 7% W/ ELECTROLYTES

HOSPIRA
7%;102MG/100ML;45MG/100ML;522MG/100ML;4
N019437 006 Apr 03, 1986

10MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,

HEPTAHYDRATE

INJECTABLE;INJECTION

AMINOSYN II 3.5% M

HOSPIRA
3.5%;30MG/100ML;97MG/100ML;120MG/100ML;
N019437 007 Apr 03, 1986

49MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

BAXTER HLTHCARE
3.5%;51MG/100ML;131MG/100ML;218MG/100ML

N020177 001 Oct 23, 1995

;35MG/100ML

TRAVASOL 3.5% W/ ELECTROLYTES

BAXTER HLTHCARE
3.5%;51MG/100ML;131MG/100ML;218MG/100ML

N017493 003

;35MG/100ML

TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

BAXTER HLTHCARE
5.5%;102MG/100ML;522MG/100ML;431MG/100M

N020173 001 Oct 27, 1995

L;224MG/100ML

TRAVASOL 5.5% W/ ELECTROLYTES

BAXTER HLTHCARE
5.5%;102MG/100ML;522MG/100ML;431MG/100M

N017493 001

L;224MG/100ML

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-21(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
BAXTER HLTHCARE
8.5%;102MG/100ML;522MG/100ML;594MG/100M
N020173 002 Oct 27, 1995
L;154MG/100ML
TRAVASOL 8.5% W/ ELECTROLYTES
BAXTER HLTHCARE
8.5%;102MG/100ML;522MG/100ML;594MG/100M
N017493 002
L;154MG/100ML
AMINOCAPROIC ACID
INJECTABLE;INJECTION
AMICAR
CLOVER PHARMS

250MG/ML **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N015229 002

250MG/ML
250MG/ML
250MG/ML

A070522 001 Jun 17, 1986

N018590 001 Oct 29, 1982
A070888 001 Jun 16, 1988

AMINOGLUTETHIMIDE
TABLET;ORAL
CYTADREN
NOVARTIS

250MG

N018202 001

AMINOHIPPURATE SODIUM
INJECTABLE;INJECTION
AMINOHIPPURATE SODIUM
MERCK

20%

N005619 001

300MG/5ML

N018232 001 Apr 02, 1982

25MG/ML
25MG/ML

A087243 001 May 24, 1982

A087621 001 May 24, 1982

AMINOCAPROIC ACID
ABRAXIS PHARM
BAXTER HLTHCARE
HOSPIRA

AMINOPHYLLINE
ENEMA;RECTAL
SOMOPHYLLIN
FISONS
INJECTABLE;INJECTION
AMINOPHYLLIN
GD SEARLE LLC
AMINOPHYLLINE
ABRAXIS PHARM

25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
ELKINS SINN
25MG/ML
HOSPIRA
25MG/ML
INTL MEDICATION
25MG/ML
25MG/ML
25MG/ML
KING PHARMS
25MG/ML
LUITPOLD
25MG/ML
LYPHOMED
25MG/ML
PHARMA SERVE NY
25MG/ML
25MG/ML
SMITH AND NEPHEW
25MG/ML
25MG/ML
TEVA PARENTERAL
25MG/ML
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%
HOSPIRA
100MG/100ML
200MG/100ML
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA
100MG/100ML
200MG/100ML
400MG/100ML
500MG/100ML
SOLUTION;ORAL
AMINOPHYLLINE
MORTON GROVE
105MG/5ML
ROXANE
105MG/5ML
AMINOPHYLLINE DYE FREE
ACTAVIS MID ATLANTIC
105MG/5ML
SOMOPHYLLIN
FISONS
105MG/5ML

A084568
A087200
A087250
A087886
A088407
A087239
A087601
A087209
A087867
A087868
A086606
A087240
A087431
A087387
A087392
A088429
A088749
A081142

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jan 06, 1982

Aug 30, 1983
Jan 25, 1984
Jul
Feb
Nov
Nov

23,
01,
10,
10,

1982
1982
1983
1983

Jun
Dec
May
May
Sep

03,
15,
30,
30,
25,

1983
1983
1985
1985
1991

A088147 002 May 03, 1983

A088147 003 May 03, 1983
N018924
N018924
N018924
N018924

001
002
003
004

Dec
Dec
Dec
Dec

12,
12,
12,
12,

1984
1984
1984
1984

A088156 001 Dec 05, 1983

A088126 001 Aug 19, 1983
A087727 001 Apr 16, 1982
A086466 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-22(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMINOPHYLLINE

SOLUTION;ORAL

SOMOPHYLLIN-DF

FISONS

SUPPOSITORY;RECTAL

TRUPHYLLINE

G AND W LABS

TABLET;ORAL

AMINOPHYLLIN

GD SEARLE LLC

AMINOPHYLLINE

ASCOT

BARR

DURAMED PHARMS BARR

HALSEY

HIKMA INTL PHARMS

IMPAX LABS

KV PHARM

LANNETT

PAL PAK

PANRAY

PUREPAC PHARM

ROXANE

SANDOZ

VALEANT PHARM INTL

VANGARD

VINTAGE PHARMS

WATSON LABS

105MG/5ML

A087045 001

250MG

500MG

A085498 001 Mar 23, 1983

A085498 002 Jan 03, 1983

100MG

200MG

N002386 002

N002386 003

100MG

200MG

100MG

200MG

100MG

200MG

100MG

100MG

200MG

100MG

200MG

100MG

200MG

100MG

200MG

100MG

100MG

200MG

100MG

200MG

100MG

200MG

100MG

100MG

200MG

200MG

100MG

200MG

100MG

200MG

100MG

200MG

A087522
A087523
A088297
A088298
A088182
A088183
A084674
A084540
A085003
A084574
A084576
A085284
A085289
A084588
A084588
A084533
A084552
A084552
A084699
A085333
A087500
A087501
A085261
A085262
A085261
A084563
A088314
A088319
A085409
A085410
A085567
A085564

001
001
001
001
001
001
001

001

001

001

001

001

001

001

002

001

001

002

001

001

001
001
003

002

002

001

001
001
001

001

001

001

A084577
A084575
A084632
A084531
A084530

001

001

002

001

001

TABLET, DELAYED RELEASE;ORAL

AMINOPHYLLINE

IMPAX LABS

100MG

200MG

TABLICAPS

100MG

VALE

100MG

200MG

TABLET, EXTENDED RELEASE;ORAL

PHYLLOCONTIN

PHARM RES ASSOC

225MG

AMINOSALICYLATE SODIUM

POWDER;ORAL

P.A.S. SODIUM

CENTURY PHARMS

SODIUM AMINOSALICYLATE

HEXCEL

TABLET;ORAL

PARASAL SODIUM

PANRAY

SODIUM P.A.S.

LANNETT

TEEBACIN

CONSOLIDATED MIDLAND

A086760 001

4GM/PACKET

A080947 001

100%

A080097 001

500MG

1GM

N006811 006

N006811 011

500MG

A080138 002

500MG

N007320 002

Feb
Feb
Aug
Aug
Mar
Mar

12,
12,
19,
19,
31,
31,

1982

1982

1983

1983

1983

1983

Feb 09, 1982

Feb 09, 1982

Oct 03, 1983

Oct 03, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-23(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID

TABLET;ORAL
NEOPASALATE
MEDPOINTE PHARM HLC
846MG;112MG
AMINOSALICYLIC ACID
TABLET;ORAL
PARASAL
PANRAY

500MG
1GM

AMINOSALICYLIC ACID RESIN COMPLEX

POWDER;ORAL

REZIPAS

BRISTOL MYERS SQUIBB
EQ 500MG BASE/GM

AMIODARONE HYDROCHLORIDE

INJECTABLE;INJECTION

AMIODARONE HYDROCHLORIDE

BEDFORD

BEDFORD LABS

BEN VENUE

HOSPIRA

INTL MEDICATION SYS

PAR STERILE PRODUCTS

TEVA PHARMS USA

CORDARONE

WYETH PHARMS INC

TABLET;ORAL

AMIODARONE HYDROCHLORIDE

TEVA

A080059 002

N006811 001
N006811 002

N009052 001

50MG/ML

50MG/ML

50MG/ML

50MG/ML

50MG/ML

50MG/ML

50MG/ML

A076018
A076299
A076088
A076108
N021594
A076394
A076163

50MG/ML

N020377 001 Aug 03, 1995

200MG

A074895 001 Apr 16, 1999

AMITRIPTYLINE HYDROCHLORIDE

CONCENTRATE;ORAL

ENDEP

ROCHE

40MG/ML

INJECTABLE;INJECTION

AMITRIPTYLINE HYDROCHLORIDE

WATSON LABS

10MG/ML

ELAVIL

ASTRAZENECA

10MG/ML

TABLET;ORAL

AMITID

BRISTOL MYERS SQUIBB
10MG

25MG

50MG

75MG

100MG

AMITRIL

WARNER CHILCOTT

10MG

25MG

50MG

75MG

100MG

150MG

AMITRIPTYLINE HYDROCHLORIDE

AM THERAP

25MG

50MG

75MG

100MG

ANI PHARMS INC

10MG

25MG

50MG

75MG

COPLEY PHARM

10MG

25MG

50MG

75MG

100MG

150MG

HALSEY

10MG

25MG

50MG

50MG

001
001
001
001
001
001
001

Oct
Oct
Oct
Oct
Feb
Apr
Sep

15,
24,
15,
15,
04,
25,
05,

2002

2002

2002

2002

2004

2003

2003

A085749 001

A085594 001

N012704 001

A086454
A086454
A086454
A086454
A086454

001

002

003

004

005

A083939
A083937
A083938
A084957
A085093
A086295

001

001

002

001

001

001

A088672
A088673
A088674
A088675
A084910
A085031
A085032
A085030
A088421
A088422
A088423
A088424
A088425
A088426
A085923
A085922
A085925
A087557

001
001
001
001
003

001

001

001

001
001
001
001
001
001
001

001

001

001

Nov
Nov
Nov
Nov

20,
20,
20,
20,

1984

1984

1984

1984

Apr
Apr
Apr
Apr
Apr
Apr

30,
30,
30,
30,
30,
30,

1984

1984

1984

1984

1984

1984

Mar 05, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-24(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE

LEDERLE

MUTUAL PHARM

PAR PHARM

PLIVA

PUREPAC PHARM

ROXANE

SUPERPHARM

TEVA

UCB INC

75MG
100MG
10MG
10MG
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
10MG
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG
10MG
10MG
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG
150MG
150MG
10MG
25MG
50MG
75MG
100MG
10MG
25MG
50MG
75MG
100MG
100MG
150MG
10MG
25MG
50MG
75MG

A085926
A085927
A086744
A087366
A086746
A087367
A086743
A087181
A086745
A087369
A086747
A087368
A087370
A085744
A085627
A085745
A085743
A085742
A089423
A088697
A088698
A088699
A088700
A088701
A088702
A088883
A088884
A088885
A088886
A088887
A088888
A088075
A088084
A088076
A088085
A088077
A088105
A088078
A088106
A088079
A088107
A086002
A086144
A085944
A086145
A085945
A086143
A086004
A086147
A086003
A086146
A086090
A086148
A088853
A088854
A088855
A088856
A088857
A086610
A086859
A086857
A086860
A085836
A086854
A086853
A085864
A085935
A085936
A086337

001
001
001

001
001

001
001

001
001

001
001

001
001
001

001

001

001

002
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

001

001

001

001

001

001

001

001

001

001

001

001
001
001
001
001
001

001

001

001

001

001

001

001

001

001

001

May 20, 1983

May 20, 1983

Jan 04, 1982

May 03, 1982

Jan 04, 1982

Jan 04, 1982

May 03, 1982

Jan 04, 1982

May
Feb
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Jul
May
Jul
Sep
Jul
Sep
Jul
Sep
Jul

11,
17,
25,
25,
25,
25,
25,
25,
26,
26,
26,
26,
26,
26,
16,
18,
20,
18,
16,
18,
16,
18,
16,
18,

1982

1987

1984

1984

1984

1984

1984

1984

1984

1984

1984

1984

1984

1984

1983

1983

1983

1983

1983

1983

1983

1983

1983

1983

Nov
Nov
Nov
Nov
Nov

13,
13,
13,
13,
13,

1984

1984

1984

1984

1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-25(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE

USL PHARMA

VANGARD

WATSON LABS

WEST WARD

ELAVIL

ASTRAZENECA

ENDEP

ROCHE

100MG

150MG

25MG

10MG

50MG

75MG

100MG

10MG

10MG

25MG

25MG

50MG

50MG

75MG

75MG

100MG

100MG

150MG

150MG

10MG

25MG

A086336
A086335
A087775
A087632
A087616
A087617
A087639
A085816
A088620
A085817
A088621
A085815
A088622
A085819
A088633
A085820
A088634
A085821
A088635
A087647
A087278

001

001

001
001
001
001
001
001

001
001

001
001

001
001

001
001

001
001

001
001
001

10MG

25MG

50MG

75MG

100MG

150MG

N012703
N012703
N012703
N012703
N012703
N012703

001

003

004

005

006

007

10MG

25MG

50MG

75MG

100MG

150MG

A083639
A083639
A083639
A083639
A083639
A085303

001

002

003

004

005

001

A070765
A070766
A072277
A072278
A070477
A070478
A072052
A072053

001
001
001
001
001
001
001
001

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET;ORAL

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

MUTUAL PHARM
EQ 12.5MG BASE;5MG

EQ 25MG BASE;10MG

PAR PHARM
EQ 12.5MG BASE;5MG

EQ 25MG BASE;10MG

USL PHARMA
EQ 12.5MG BASE;5MG

EQ 25MG BASE;10MG

WATSON LABS
EQ 12.5MG BASE;5MG

EQ 25MG BASE;10MG

LIMBITROL

HERITAGE PHARMS INC
EQ 12.5MG BASE;5MG

LIMBITROL DS

HERITAGE PHARMS INC
EQ 25MG BASE;10MG

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET;ORAL

ETRAFON 2-10

SCHERING
10MG;2MG

ETRAFON 2-25

SCHERING
25MG;2MG

ETRAFON-A

SCHERING
10MG;4MG

ETRAFON-FORTE

SCHERING
25MG;4MG

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

IVAX SUB TEVA PHARMS
10MG;2MG

10MG;4MG

25MG;2MG

25MG;4MG

50MG;4MG

MUTUAL PHARM
10MG;2MG

10MG;4MG

Feb
Feb
Feb
Feb
Feb

10,
01,
08,
05,
08,

1982

1982

1982

1982

1982

Mar 02, 1984

Mar 02, 1984

Mar 02, 1984

Mar 02, 1984

Mar 02, 1984

Mar 02, 1984

Mar 05, 1982

Dec
Dec
May
May
Jan
Jan
Dec
Dec

10,
10,
09,
09,
12,
12,
16,
16,

1986

1986

1988

1988

1988

1988

1988

1988

Sep
Sep
Sep
Sep
Sep
Nov
Nov

11,
11,
11,
11,
12,
12,
12,

1986

1986

1986

1986

1986

1986

1986

N016949 001

N016949 002

N014713 007

N014713 004

N014713 002

N014713 006

A070935
A070937
A070936
A070938
A070939
A071077
A071078

001
001
001
001
001
001
001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-26(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
TABLET;ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
25MG;2MG
25MG;4MG
PAR PHARM
10MG;2MG
10MG;4MG
25MG;2MG
25MG;4MG
50MG;4MG
SANDOZ
10MG;2MG
10MG;4MG
25MG;2MG
25MG;4MG
50MG;4MG
WATSON LABS
10MG;2MG
10MG;2MG
10MG;2MG
10MG;4MG
10MG;4MG
10MG;4MG
25MG;2MG
25MG;2MG
25MG;2MG
25MG;4MG
25MG;4MG
25MG;4MG
50MG;4MG
50MG;4MG
50MG;4MG
TRIAVIL 2-10
NEW RIVER
10MG;2MG
TRIAVIL 2-25
NEW RIVER
25MG;2MG
TRIAVIL 4-10
NEW RIVER
10MG;4MG
TRIAVIL 4-25
NEW RIVER
25MG;4MG
TRIAVIL 4-50
NEW RIVER
50MG;4MG
AMLEXANOX
PASTE;DENTAL
APHTHASOL
ULURU
PATCH;TOPICAL
AMLEXANOX
ULURU
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
GEDEON RICHTER USA

A070297
A071079
A070565
A070620
A070621
A070595
A070574
A071062
A071862
A071063
A071064
A071863
A070373
A072539
A073007
A070375
A072540
A073009
A070374
A072541
A073008
A070376
A072134
A073010
A070377
A071558
A072135

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Nov
Nov
Sep
Sep
Sep
Sep
Sep
Nov
Dec
Nov
Nov
Dec
Aug
Feb
Oct
Aug
Feb
Oct
Aug
Feb
Oct
Aug
Feb
Oct
Nov
Mar
Feb

12,
12,
11,
11,
11,
11,
11,
27,
21,
27,
27,
21,
25,
15,
17,
25,
15,
17,
25,
15,
17,
25,
15,
17,
04,
02,
15,

1986
1986
1986
1986
1986
1986
1986
1987
1987
1987
1987
1987
1986
1989
1991
1986
1989
1991
1986
1989
1991
1986
1989
1991
1986
1987
1989

N014715 004
N014715 002
N014715 003
N014715 005
N014715 006

5%

N020511 001 Dec 17, 1996

2MG

N021727 001 Sep 29, 2004

EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
GENPHARM
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
MUTUAL PHARMA
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
PURACAP PHARM
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
SANDOZ
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
SYNTHON PHARMS
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
TABLET, ORALLY DISINTEGRATING;ORAL
AMLODIPINE BESYLATE
SYNTHON PHARMS
EQ 2.5MG BASE

A077333
A077333
A077333
A077362
A077362
A077362
A078081
A078081
A078081
A078131
A078131
A078131
A076859
A076859
A076859
A077080
A077080
A077080

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jul
Jul
Jul
Jul
Jul
Jul
Jan
Jan
Jan
Sep
Sep
Sep
Sep
Sep
Sep
Jun
Jun
Jun

17,
17,
17,
09,
09,
09,
31,
31,
31,
04,
04,
04,
10,
10,
10,
27,
27,
27,

2007
2007
2007
2007
2007
2007
2008
2008
2008
2007
2007
2007
2007
2007
2007
2007
2007
2007

N022026 001 Sep 27, 2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-27(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMLODIPINE BESYLATE
TABLET, ORALLY DISINTEGRATING;ORAL
AMLODIPINE BESYLATE
EQ 5MG BASE
EQ 10MG BASE
AMLODIPINE MALEATE
TABLET;ORAL
AMVAZ
DR REDDYS LABS INC

AMMONIA N-13
INJECTABLE;INTRAVENOUS
AMMONIA N 13
CENTRAL RADIOPHARM

2.5MG
5MG
10MG

N021435 001 Oct 31, 2003

N021435 002 Oct 31, 2003
N021435 003 Oct 31, 2003

3.75-260mCi/ML

A204539 001 Jun 23, 2015

AMMONIUM CHLORIDE
INJECTABLE;INJECTION
AMMONIUM CHLORIDE
ABBOTT
5MEQ/ML
GD SEARLE LLC
3MEQ/ML
AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
MCGAW
900MG/100ML
AMMONIUM CHLORIDE 2.14%
B BRAUN
40MEQ/100ML
AMODIAQUINE HYDROCHLORIDE
TABLET;ORAL
CAMOQUIN HYDROCHLORIDE
PARKE DAVIS
AMOXAPINE
TABLET;ORAL
AMOXAPINE
SANDOZ

WATSON LABS

ASENDIN
LEDERLE

AMOXICILLIN
CAPSULE;ORAL
AMOXICILLIN
LABS ATRAL
MYLAN
TEVA

AMOXIL
GLAXOSMITHKLINE
TRIMOX
APOTHECON

UTIMOX
PARKE DAVIS

N022026 002 Sep 27, 2007

N022026 003 Sep 27, 2007

A083130 001
A086205 001
N006580 001
A085734 001

EQ 200MG BASE

N006441 001

25MG
50MG
100MG
150MG
25MG
50MG
100MG
150MG

A072943
A072944
A072878
A072879
A072418
A072419
A072420
A072421

001
001
001
001
001
001
001
001

25MG
50MG
100MG
150MG

N018021
N018021
N018021
N018021

001
002
003
004

250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG

A062528
A062528
A062067
A062067
A062853
A063030
A062854
A063031

001
002
001
002
001
001
001
001

250MG
500MG

N050459 001
N050459 002

250MG
250MG
250MG
250MG
500MG
500MG
500MG
500MG

A061885
A062098
A062152
A063099
A061885
A062098
A062152
A063099

250MG

A062107 001

Jun
Jun
Jun
Jun
May
May
May
May

28,
28,
28,
28,
11,
11,
11,
11,

1991
1991
1991
1991
1989
1989
1989
1989

Aug 07, 1985

Aug 07, 1985

Dec
Feb
Dec
Feb

22,
28,
22,
28,

1987
1989
1987
1989

001
001
001
001 Mar 20, 1992
002
002
002
002 Mar 20, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-28(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMOXICILLIN

CAPSULE;ORAL

UTIMOX

WYMOX

WYETH AYERST

FOR SUSPENSION;ORAL

AMOXICILLIN

AM ANTIBIOTICS

MYLAN

SUN PHARM INDS LTD

TEVA

AMOXIL

GLAXOSMITHKLINE

LAROTID

GLAXOSMITHKLINE

POLYMOX

APOTHECON

TRIMOX

APOTHECON

UTIMOX

PARKE DAVIS

WYMOX

WYETH AYERST

TABLET;ORAL

AMOXICILLIN

DAVA PHARMS INC

TABLET, CHEWABLE;ORAL

AMOXICILLIN

APOTHECON

DAVA PHARMS INC

SUN PHARM INDS LTD

TEVA

AMOXIL

DR REDDYS LABS INC

TABLET, FOR SUSPENSION;ORAL

AMOXICILLIN

AUROBINDO PHARMA LTD

DISPERMOX

RANBAXY LABS LTD

500MG

A062107 002

250MG
500MG

A062120 001
A062120 002

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
200MG/5ML
400MG/5ML
125MG/5ML
250MG/5ML

A062059
A062059
A062090
A062090
A065113
A065113
A062946
A063001

50MG/ML
125MG/5ML
250MG/5ML

N050460 005
N050460 001
N050460 002

50MG/ML

N050460 006

125MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML

A061851
A062323
A061851
A062323

001
001
002
002

50MG/ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML

A061886
A061886
A062099
A062154
A062885
A061886
A062099
A062154
A062885

001
002
001
001
001 Mar 08, 1988
003
002
002
002 Mar 08, 1988

125MG/5ML
250MG/5ML

A062127 001
A062127 002

125MG/5ML
250MG/5ML

A062131 001
A062131 002

875MG

A065344 001 Jan 15, 2009

125MG
250MG
125MG
250MG
200MG
400MG
125MG
250MG

A064131
A064131
A064139
A064139
A065060
A065060
A064031
A064031

200MG
400MG

N050761 001 Apr 15, 1999

N050761 002 Apr 15, 1999

200MG
400MG

A065324 001 Jan 17, 2007

A065324 002 Jan 17, 2007

200MG
400MG
600MG

A065080 002 Aug 11, 2003

A065080 001 Aug 11, 2003
A065159 001 Dec 04, 2003

001
002
001
002
001
002
001
001

001
002
001
002
001
002
001
002

Nov
Nov
Nov
Jan

May
May
Jan
Jan
Nov
Nov
Dec
Dec

29,
29,
01,
06,

06,
06,
29,
29,
29,
29,
19,
19,

2002
2002
1988
1989

1996
1996
1996
1996
2000
2000
1996
1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-29(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMOXICILLIN; CLAVULANATE POTASSIUM
TABLET;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
APOTEX INC
250MG;EQ 125MG
500MG;EQ 125MG
875MG;EQ 125MG
SUN PHARM INDS LTD
500MG;EQ 125MG

BASE
BASE
BASE
BASE

A065333
A065333
A065317
A065109

001
002
003
001

Feb
Feb
Oct
Nov

24,
24,
20,
04,

2009
2009
2008
2002

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

CAPSULE;ORAL

DELCOBESE

TEVA

1.25MG;1.25MG;1.25MG;1.25MG **Federal

A083564 001

Register determination that product was

not discontinued or withdrawn for

safety or efficacy reasons**

2.5MG;2.5MG;2.5MG;2.5MG **Federal

A083564 002

Register determination that product was

not discontinued or withdrawn for

safety or efficacy reasons**

3.75MG;3.75MG;3.75MG;3.75MG **Federal

A083564 003

Register determination that product was

not discontinued or withdrawn for

safety or efficacy reasons**

5MG;5MG;5MG;5MG **Federal Register

A083564 004

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

TABLET;ORAL

DELCOBESE

TEVA

1.25MG;1.25MG;1.25MG;1.25MG

A083563 004

2.5MG;2.5MG;2.5MG;2.5MG

A083563 003

3.75MG;3.75MG;3.75MG;3.75MG

A083563 002

5MG;5MG;5MG;5MG

A083563 001

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE

SULFATE

TABLET;ORAL

ADDERALL 10

2.5MG;2.5MG;2.5MG;2.5MG **Federal
TEVA WOMENS

N011522 007 Feb 13,
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
ADDERALL 12.5

TEVA WOMENS

3.125MG;3.125MG;3.125MG;3.125MG
N011522 012 Aug 31,
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
ADDERALL 15

TEVA WOMENS

3.75MG;3.75MG;3.75MG;3.75MG **Federal
N011522 013 Aug 31,
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
ADDERALL 20

TEVA WOMENS

5MG;5MG;5MG;5MG **Federal Register
N011522 008 Feb 13,
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ADDERALL 30

TEVA WOMENS

7.5MG;7.5MG;7.5MG;7.5MG **Federal
N011522 010 May 12,
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
ADDERALL 5

TEVA WOMENS

1.25MG;1.25MG;1.25MG;1.25MG **Federal
N011522 009 May 12,
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
ADDERALL 7.5

TEVA WOMENS

1.875MG;1.875MG;1.875MG;1.875MG
N011522 011 Aug 31,
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

TEVA PHARMS
1.25MG;1.25MG;1.25MG;1.25MG
A040472 001 Sep 30,
2.5MG;2.5MG;2.5MG;2.5MG
A040472 002 Sep 30,
5MG;5MG;5MG;5MG
A040472 003 Sep 30,

1996

2000

2000

1996

1997

1997

2000

2003

2003

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-30(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE

SULFATE

TABLET;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

7.5MG;7.5MG;7.5MG;7.5MG
A040472 004 Sep 30, 2003

AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE;ORAL

BIPHETAMINE 12.5
UCB INC
EQ 6.25MG BASE;EQ 6.25MG BASE
BIPHETAMINE 20
UCB INC
EQ 10MG BASE;EQ 10MG BASE
BIPHETAMINE 7.5
UCB INC
EQ 3.75MG BASE;EQ 3.75MG BASE
AMPHETAMINE SULFATE
TABLET;ORAL
AMPHETAMINE SULFATE
LANNETT
AMPHOTERICIN B
CREAM;TOPICAL
FUNGIZONE
APOTHECON
INJECTABLE;INJECTION
AMPHOTERICIN B
ABBOTT
ABRAXIS PHARM
TEVA PARENTERAL
FUNGIZONE
APOTHECON
LOTION;TOPICAL
FUNGIZONE
APOTHECON
OINTMENT;TOPICAL
FUNGIZONE
APOTHECON
SUSPENSION;ORAL
FUNGIZONE
BRISTOL MYERS SQUIBB
AMPICILLIN SODIUM
INJECTABLE;INJECTION
AMPICILLIN SODIUM
APOTHECON

CONSOLIDATED PHARM

HANFORD GC

HIKMA MAPLE

INTL MEDICATION
LILLY

WATSON LABS INC

N010093 007
N010093 003
N010093 009

5MG
10MG

A083901 001 Aug 31, 1984

A083901 002 Aug 31, 1984

3%

N050314 001

50MG/VIAL
50MG/VIAL
50MG/VIAL

A064141 001 Dec 23, 1996

A062728 001 Apr 13, 1987
A064062 001 Mar 31, 1995

50MG/VIAL

A060517 001

3%

A060570 001

3%

N050313 001

100MG/ML

N050341 003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A062860
A062860
A062860
A062860
A062860
A061936
A061936
A061936
A061936
A061936
A063143
A063147
A063139
A063141
A062692
A062692
A062692
A062692
A062692
A062692
A062634
A062634
A062565
A062565
A062565
A062816
A062816
A062816
A062816
A062816

125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL

001
002
003
004
005
005
001
002
003
004
001
001
001
001
001
002
003
004
005
006
002
003
001
002
003
001
002
003
004
005

Feb
Feb
Feb
Feb
Feb

05,
05,
05,
05,
05,

1988
1988
1988
1988
1988

Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun
Jan
Jan
Apr
Apr
Jun
Oct
Oct
Oct
Oct
Oct

15,
15,
15,
15,
24,
24,
24,
24,
24,
24,
09,
09,
04,
04,
24,
24,
24,
24,
24,
24,

1993
1993
1993
1993
1986
1986
1986
1986
1986
1986
1987
1987
1985
1985
1986
1988
1988
1988
1988
1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-31(of 347)

DISCONTINUED DRUG PRODUCT LIST

AMPICILLIN SODIUM

INJECTABLE;INJECTION

AMPICILLIN SODIUM

OMNIPEN-N

WYETH AYERST

PENBRITIN-S

WYETH AYERST

POLYCILLIN-N

BRISTOL

TOTACILLIN-N

GLAXOSMITHKLINE

EQ 10GM BASE/VIAL

A062994 001 Sep 15, 1988

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL

125MG BASE/VIAL

250MG BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

2GM BASE/VIAL

A060626
A062718
A060626
A062718
A060626
A062718
A060626
A062718
A060626
A062718

001

001
002

002
003

003
004

004
005

005

EQ
EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

N050072
N050072
N050072
N050072
N050072
N050072

001

002

003

004

005

006

EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

N050309
N050309
N050309
N050309
N050309

001

002

003

004

005

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

2GM BASE/VIAL

10GM BASE/VIAL

A060677
A060677
A060677
A060677
A062727
A060677
A062727
A060677

001

002

003

004

001 Dec 19, 1986

005

002 Dec 19, 1986

006

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE;INJECTION

UNASYN

PFIZER
EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL

AMPICILLIN/AMPICILLIN TRIHYDRATE

CAPSULE;ORAL

AMCILL

PARKE DAVIS
EQ 250MG
EQ 500MG
AMPICILLIN TRIHYDRATE

AM ANTIBIOTICS
EQ 250MG
EQ 500MG
IVAX SUB TEVA PHARMS
EQ 250MG
EQ 500MG
LEDERLE
EQ 250MG
EQ 500MG
MYLAN
EQ 250MG
EQ 500MG
PUREPAC PHARM
EQ 250MG
EQ 500MG
TEVA
EQ 250MG
EQ 500MG
VITARINE
EQ 250MG
EQ 500MG
OMNIPEN (AMPICILLIN)

WYETH AYERST
250MG

500MG

PENBRITIN

WYETH AYERST
EQ 250MG
EQ 500MG
PFIZERPEN-A

PFIZER
EQ 250MG
EQ 500MG

Dec 16, 1986

Dec 16, 1986

Dec 16, 1986

Dec 16, 1986

Dec 16, 1986

N050608 003 Dec 31, 1986

BASE

BASE

A062041 001

A062041 002

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A061602
A061602
A060765
A060765
A062208
A062208
A061755
A061755
A061853
A061853
A061502
A061502
A061387
A061387

001

002

001

002

001

002

001

002

001

002

001

002

001

003

A060624 001

A060624 002

BASE

BASE

A060908 001

A060908 002

BASE

BASE

A062050 001

A062050 002

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AMPICILLIN/AMPICILLIN TRIHYDRATE

CAPSULE;ORAL

POLYCILLIN

BRISTOL
EQ 250MG BASE

EQ 500MG BASE

PRINCIPEN

APOTHECON
EQ 250MG BASE

EQ 500MG BASE

BRISTOL MYERS SQUIBB
EQ 250MG BASE

EQ 500MG BASE

PRINCIPEN '250'

APOTHECON
EQ 250MG BASE

EQ 250MG BASE

PRINCIPEN '500'

APOTHECON
EQ 500MG BASE

EQ 500MG BASE

TOTACILLIN

GLAXOSMITHKLINE
EQ 250MG BASE

EQ 250MG BASE

EQ 500MG BASE

EQ 500MG BASE

FOR SUSPENSION;ORAL

AMCILL

PARKE DAVIS
EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

AMPICILLIN TRIHYDRATE

AM ANTIBIOTICS
EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

MYLAN
EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

PUREPAC PHARM
EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

TEVA
EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

OMNIPEN (AMPICILLIN)

WYETH AYERST
100MG/ML

125MG/5ML

250MG/5ML

500MG/5ML

PENBRITIN

WYETH AYERST
EQ 100MG BASE/ML

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

PFIZERPEN-A

PFIZER
EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

POLYCILLIN

APOTHECON
EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

BRISTOL
EQ 100MG BASE/ML

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

EQ 500MG BASE/5ML

PRINCIPEN

APOTHECON
EQ 100MG BASE/ML

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

PRINCIPEN '125'

APOTHECON
EQ 125MG BASE/5ML

EQ 125MG BASE/5ML

PRINCIPEN '250'

APOTHECON
EQ 250MG BASE/5ML

EQ 250MG BASE/5ML

TOTACILLIN

GLAXOSMITHKLINE
EQ 125MG BASE/5ML

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

EQ 250MG BASE/5ML

TABLET, CHEWABLE;ORAL

POLYCILLIN

BRISTOL
EQ 125MG BASE

N050310 001

N050310 002

A062888
A062888
A061392
A061392

001 Mar 04, 1988

002 Mar 04, 1988

001

002

A062157 002

N050056 001

A062157 001

N050056 002

A060060
A062212
A060060
A062212

001

001

002

002

A062030 001

A062030 002

A061601
A061601
A061829
A061829
A061980
A061980
A061370
A061370

001

002

002

001

001

002

001

002

A060625
A060625
A060625
A060625

001

002

003

004

N050019 001

N050019 002

N050019 003

A062049 001

A062049 002

A062297
A062297
N050308
N050308
N050308
N050308

001

002

004

001

002

003

A061394 001

A061394 002

A061394 003

A060127 002

A062151 001

A060127 001

A062151 002

A060666
A062223
A060666
A062223

001

001

002

002

N050093 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

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DISCONTINUED DRUG PRODUCT LIST

AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID

CAPSULE;ORAL

PRINCIPEN W/ PROBENECID

APOTHECON

EQ 389MG BASE;111MG

EQ 389MG BASE;111MG

FOR SUSPENSION;ORAL

POLYCILLIN-PRB

APOTHECON

EQ 3.5GM BASE/BOT;1GM/BOT

BRISTOL

EQ 3.5GM BASE/BOT;1GM/BOT

PROBAMPACIN

G AND W LABS INC

EQ 3.5GM BASE/BOT;1GM/BOT

AMPRENAVIR

CAPSULE;ORAL

AGENERASE

GLAXOSMITHKLINE

SOLUTION;ORAL

AGENERASE

GLAXOSMITHKLINE

ANAGRELIDE HYDROCHLORIDE

CAPSULE;ORAL

AGRYLIN

SHIRE LLC

ANAGRELIDE HYDROCHLORIDE

ROXANE

SANDOZ INC

WATSON LABS

A062150 001

N050488 001

A061898 001

N050457 001

A061741 001

50MG

150MG

N021007 001
Apr 15, 1999

N021007 002
Apr 15, 1999

15MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N021039 001
Apr 15, 1999

EQ 1MG BASE

N020333 002
Mar 14, 1997

EQ
EQ
EQ
EQ
EQ
EQ

A076489
A076489
A076683
A076683
A076417
A076417

001

002

001

002

001

002

Apr
Apr
Apr
Apr
Apr
Apr

18,
18,
18,
18,
18,
18,

2005

2005

2005

2005

2005

2005

001

001

001

001

May
Jan
Jun
Jun

31,
05,
28,
28,

2012

2011

2010

2010

0.5MG BASE

1MG BASE

0.5MG BASE

1MG BASE

0.5MG BASE

1MG BASE

ANASTROZOLE

TABLET;ORAL

ANASTROZOLE

IMPAX LABS INC

KREMERS URBAN PHARMS

SYNTHON PHARMS

WATSON LABS

1MG

1MG

1MG

1MG

A091242
A091331
A078322
A078984

ANILERIDINE HYDROCHLORIDE

TABLET;ORAL

LERITINE

MERCK

EQ 25MG BASE

N010585 002

ANILERIDINE PHOSPHATE

INJECTABLE;INJECTION

LERITINE

MERCK

25MG/ML

N010520 003

ANISINDIONE

TABLET;ORAL

MIRADON

SCHERING

50MG

N010909 003

ANISOTROPINE METHYLBROMIDE

TABLET;ORAL

ANISOTROPINE METHYLBROMIDE

WATSON LABS

50MG

VALPIN 50

ENDO PHARMS

50MG

ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

VASOCON-A

NOVARTIS
0.5%;0.05%

A086046 001

N013428 001

N018746 002
Jul 11, 1994

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DISCONTINUED DRUG PRODUCT LIST

APOMORPHINE HYDROCHLORIDE

INJECTABLE;SUBCUTANEOUS

APOKYN

US WORLDMEDS

20MG/2ML (10MG/ML)

N021264 001
Apr 20, 2004

APROTININ

INJECTABLE;INJECTION

TRASYLOL

BAYER HLTHCARE

10,000KIU/ML

N020304 001
Dec 29, 1993

ARBUTAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

GENESA

GENSIA AUTOMEDICS

0.05MG/ML

N020420 001
Sep 12, 1997

5,000 UNITS/0.5ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

10,000 UNITS/0.5ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N020227 002
May 23, 1997

125MG/125ML (1MG/ML)

N201743 001
May 09, 2011

ARDEPARIN SODIUM

INJECTABLE;INJECTION

NORMIFLO

PHARMACIA AND UPJOHN

ARGATROBAN

SOLUTION;IV (INFUSION)

ARGATROBAN IN DEXTROSE

SANDOZ

ARIPIPRAZOLE

SOLUTION;ORAL

ABILIFY

OTSUKA

1MG/ML **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

TABLET, ORALLY DISINTEGRATING;ORAL

ABILIFY

OTSUKA

20MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

30MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

ARMODAFINIL

TABLET;ORAL

ARMODAFINIL

MYLAN PHARMS INC

WATSON LABS INC

NUVIGIL

CEPHALON

N020227 001
May 23, 1997

N021713 001
Dec 10, 2004

N021729 004
Jun 07, 2006

N021729 005
Jun 07, 2006

50MG

150MG

250MG

100MG

200MG

A200043
A200043
A200043
A200156
A200156

001

002

003

002

004

Jun
Jun
Jun
Aug
Aug

01,
01,
01,
29,
29,

2012

2012

2012

2012

2012

100MG

N021875 002
Mar 26, 2009

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A

PALMITATE; VITAMIN E
INJECTABLE;INJECTION
BEROCCA PN
ROCHE
50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;
N006071 003 Oct 10, 1985
100
IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;

VITAMIN E

INJECTABLE;INJECTION

M.V.C. 9+3

ABRAXIS PHARM
10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2
N018440 002 Aug 08, 1985

0

IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-35(of 347)

DISCONTINUED DRUG PRODUCT LIST

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;

VITAMIN E
INJECTABLE;INJECTION
M.V.I.-12
HOSPIRA
10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2
N008809 004 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
MVC PLUS
WATSON LABS
10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2
N018439 002 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

INJECTABLE;INJECTION

M.V.I.-12

HOSPIRA
20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2
N008809 005 Apr 22, 2004

0

IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/M

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E

INJECTABLE;INJECTION

M.V.I.-12 LYOPHILIZED

IGI LABS INC
100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M
N018933 002 Aug 08, 1985

G/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4

MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10

MG/VIAL

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID;

PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E

INJECTABLE;INJECTION

VITAPED

HOSPIRA
N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001
N020176 001 Dec 29, 1993

MG/VIAL;400

IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VI

AL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/

VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ

2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE;

SODIUM SULFATE

FOR SOLUTION;ORAL

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC

NOVEL LABS INC
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
A090145 001 Jan 25, 2012

ASPIRIN

TABLET;ORAL

BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN

BAYER

500MG

TABLET, EXTENDED RELEASE;ORAL

8-HOUR BAYER

BAYER

650MG

MEASURIN

BAYER

650MG

ASPIRIN; BUTALBITAL

TABLET;ORAL

AXOTAL

SAVAGE LABS

650MG;50MG

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

BUTALBITAL, ASPIRIN AND CAFFEINE

MUTUAL PHARM
325MG;50MG;40MG

WATSON LABS
325MG;50MG;40MG

TABLET;ORAL

BUTALBITAL, ASPIRIN AND CAFFEINE

ACTAVIS ELIZABETH

325MG;50MG;40MG

HALSEY

325MG;50MG;40MG

IVAX PHARMS

325MG;50MG;40MG

PURACAP PHARM

325MG;50MG;40MG

QUANTUM PHARMICS

325MG;50MG;40MG

SANDOZ

325MG;50MG;40MG

WATSON LABS

325MG;50MG;40MG

FIORINAL

ACTAVIS LABS UT INC

325MG;50MG;40MG

N021317 001 Oct 18, 2001

N016030 001

N016030 002

A088305 001 Oct 13, 1983

A078149 001 Jun 13, 2007

A086231 002 Feb 12, 1985

A086710
A089448
A085441
A087048
A088972
A086398
A086237

002
001
002
002
001
002
002

Aug
Dec
Oct
Dec
Jun
Apr
Mar

23,
01,
31,
09,
18,
06,
23,

1983

1986

1984

1983

1985

1984

1984

N017534 003 Apr 16, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

ASPIRIN; BUTALBITAL; CAFFEINE
TABLET;ORAL
LANORINAL
LANNETT

325MG;50MG;40MG

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE;ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
VINTAGE PHARMS LLC
325MG;50MG;40MG;30MG
WATSON LABS
325MG;50MG;40MG;30MG
ASPIRIN; CAFFEINE; ORPHENADRINE
TABLET;ORAL
INVAGESIC
SANDOZ
INVAGESIC FORTE
SANDOZ
NORGESIC
MEDICIS

6-36(of 347)

A086986 002 Oct 18, 1985

A075351 001 Mar 05, 1999

A074359 001 Aug 31, 1995

CITRATE

385MG;30MG;25MG

A074817 001 Nov 27, 1996

770MG;60MG;50MG

A074817 002 Nov 27, 1996

385MG;30MG;25MG **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N013416 003 Oct 27, 1982

770MG;60MG;50MG **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
STEVENS J
385MG;30MG;25MG
770MG;60MG;50MG
ORPHENGESIC
PRINSTON INC
385MG;30MG;25MG
ORPHENGESIC FORTE
PRINSTON INC
770MG;60MG;50MG

N013416 004 Oct 27, 1982

NORGESIC FORTE
MEDICIS

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

CAPSULE;ORAL
COMPOUND 65
ALRA
389MG;32.4MG;65MG
DARVON COMPOUND
XANODYNE PHARM
389MG;32.4MG;32MG
DARVON COMPOUND-65
XANODYNE PHARM
389MG;32.4MG;65MG
PROPOXYPHENE COMPOUND 65
IVAX SUB TEVA PHARMS
389MG;32.4MG;65MG
SANDOZ
389MG;32.4MG;65MG
TEVA
389MG;32.4MG;65MG
PROPOXYPHENE COMPOUND-65
SANDOZ
389MG;32.4MG;65MG
PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE
WATSON LABS
389MG;32.4MG;65MG
ASPIRIN; CARISOPRODOL
TABLET;ORAL
CARISOPRODOL COMPOUND
WATSON LABS

325MG;200MG

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

TABLET;ORAL
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
MIRROR PHARMS
325MG;200MG;16MG
PROSAM LABS
325MG;200MG;16MG
ASPIRIN; HYDROCODONE BITARTRATE
TABLET;ORAL
AZDONE
SCHWARZ PHARMA
500MG;5MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
VICOPRIN
ABBOTT
500MG;5MG

A074988 001 Apr 30, 1999

A074988 002 Apr 30, 1999
A075141 001 May 29, 1998
A075141 002 May 29, 1998

A084553 002 Aug 17, 1983

N010996 006 Mar 08, 1983
N010996 007 Mar 08, 1983
A083077 002 Dec 07, 1984
A080044 002 Sep 16, 1983
A089025 001 Mar 29, 1985
A083101 002 Jun 24, 1985
A085732 002 Sep 03, 1984

A088809 001 Oct 03, 1985

A040860 001 Jan 07, 2010

A040283 001 Dec 29, 1998

A089420 001 Jan 25, 1988

A086333 001 Sep 14, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-37(of 347)

DISCONTINUED DRUG PRODUCT LIST

ASPIRIN; MEPROBAMATE

TABLET;ORAL

EQUAGESIC

CARACO

MEPRO-ASPIRIN

SANDOZ

MEPROBAMATE AND ASPIRIN

PAR PHARM

MICRAININ

MEDPOINTE PHARM HLC

Q-GESIC

QUANTUM PHARMICS

ASPIRIN; METHOCARBAMOL

TABLET;ORAL

METHOCARBAMOL AND ASPIRIN

IVAX SUB TEVA PHARMS

MCNEIL

PAR PHARM

ROBAXISAL

ROBINS AH

325MG;200MG

N011702 003
Dec 29, 1983

325MG;200MG

A089127 001
Mar 02, 1987

325MG;200MG

A089126 001
Aug 19, 1986

325MG;200MG

A084978 001

325MG;200MG

A088740 001
Jun 01, 1984

325MG;400MG

325MG;400MG

325MG;400MG

A087211 001
Dec 22, 1982

A089193 001
Feb 12, 1986

A089657 001
Nov 04, 1988

325MG;400MG

N012281 001

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

TABLET;ORAL

CODOXY

HALSEY
325MG;4.5MG;0.38MG

OXYCODONE AND ASPIRIN

MUTUAL PHARM
325MG;4.5MG;0.38MG

325MG;4.5MG;0.38MG

WATSON LABS
325MG;4.5MG;0.38MG

OXYCODONE AND ASPIRIN (HALF-STRENGTH)

ROXANE

325MG;2.25MG;0.19MG

PERCODAN

ENDO PHARMS

325MG;4.5MG;0.38MG

PERCODAN-DEMI

ENDO PHARMS

325MG;2.25MG;0.19MG

ROXIPRIN

ROXANE

325MG;4.5MG;0.38MG

ASPIRIN; PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

TALWIN COMPOUND

SANOFI AVENTIS US

325MG;EQ 12.5MG BASE

ASPIRIN; PRAVASTATIN SODIUM

TABLET, TABLET;ORAL

PRAVIGARD PAC (COPACKAGED)

BRISTOL MYERS SQUIBB

325MG,N/A;N/A,80MG

TABLET, TABLET, TABLET;ORAL

PRAVIGARD PAC (COPACKAGED)

BRISTOL MYERS SQUIBB

81MG,N/A;N/A,20MG

81MG,N/A;N/A,40MG

81MG,N/A;N/A,80MG

325MG,N/A;N/A,20MG

325MG,N/A;N/A,40MG

ASPIRIN; PROPOXYPHENE HYDROCHLORIDE

CAPSULE;ORAL

DARVON W/ ASA

XANODYNE PHARM

325MG;65MG

ASPIRIN; PROPOXYPHENE NAPSYLATE

CAPSULE;ORAL

DARVON-N W/ ASA

AAIPHARMA LLC

325MG;100MG

TABLET;ORAL

DARVON-N W/ ASA

AAIPHARMA LLC

325MG;100MG

ATAZANAVIR SULFATE

CAPSULE;ORAL

REYATAZ

BRISTOL MYERS SQUIBB

EQ 100MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

A087464 001
Jul 01, 1982

A040260 001
Jul 17, 1998

A087794 001
May 26, 1982

A040255 001
Feb 27, 1998

A087742 001
Jun 04, 1982

N007337 006

N007337 005

A087743 001
Jun 04, 1982

N016891 001

N021387 006
Jun 24, 2003

N021387
N021387
N021387
N021387
N021387

001

002

003

004

005

Jun
Jun
Jun
Jun
Jun

24,
24,
24,
24,
24,

2003

2003

2003

2003

2003

N010996 005

N016829 001

N016863 001

N021567 001
Jun 20, 2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-38(of 347)

DISCONTINUED DRUG PRODUCT LIST

ATENOLOL
INJECTABLE;INJECTION
TENORMIN
ASTRAZENECA

TABLET;ORAL
ATENOLOL
ABLE

APOTHECON
DAVA PHARMS INC
MYLAN

NOSTRUM LABS
PLIVA

SANDOZ

SCS
TEVA
TEVA PHARMS
WATSON LABS

0.5MG/ML **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N019058 001 Sep 13, 1989

25MG
50MG
100MG
50MG
100MG
25MG
25MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG

A076907
A076907
A076907
A073317
A073318
A074099
A074126
A074126
A074126
A074127
A074127
A074101
A074101
A074101
A074265
A074265
A074265
A073676
A073676
A073315
A073316
A074120
A074120
A073352
A073353

001
002
003
001
001
001
003
001
002
001
002
001
002
003
001
002
003
001
002
001
001
001
002
001
001

Jul
Jul
Jul
Mar
Mar
Apr
Aug
Mar
Mar
Feb
Feb
Jul
Jul
Jul
Feb
Feb
Feb
Oct
Oct
May
May
Feb
Feb
Dec
Dec

30,
30,
30,
20,
20,
28,
26,
23,
23,
21,
21,
17,
17,
17,
28,
28,
28,
30,
30,
28,
28,
24,
24,
27,
27,

2004
2004
2004
1992
1992
1992
1998
1994
1994
1995
1995
1997
1997
1997
1994
1994
1994
1992
1992
1993
1993
1995
1995
1991
1991

A074404
A074404
A074107
A074107

001
002
001
002

May
May
Sep
Sep

14,
14,
24,
24,

1998
1998
1997
1997

18MG
25MG
40MG
60MG
80MG
100MG

A079017
A079017
A079017
A079017
A079017
A079017

001
002
003
004
005
006

Sep
Sep
Sep
Sep
Sep
Sep

17,
17,
17,
17,
17,
17,

2010
2010
2010
2010
2010
2010

5MG

N021411 001 Nov 26, 2002

ATENOLOL; CHLORTHALIDONE
TABLET;ORAL
ATENOLOL AND CHLORTHALIDONE
NOSTRUM LABS
50MG;25MG
100MG;25MG
PLIVA
50MG;25MG
100MG;25MG
ATOMOXETINE HYDROCHLORIDE
CAPSULE;ORAL
ATOMOXETINE HYDROCHLORIDE
ZYDUS PHARMS USA INC

STRATTERA
LILLY
ATORVASTATIN CALCIUM
TABLET;ORAL
ATORVASTATIN CALCIUM
TEVA PHARMS

EQ
EQ
EQ
EQ

10MG
20MG
40MG
80MG

BASE
BASE
BASE
BASE

ATORVASTATIN CALCIUM; EZETIMIBE

TABLET;ORAL
LIPTRUZET
MERCK SHARP DOHME
EQ 10MG BASE;10MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 20MG BASE;10MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 40MG BASE;10MG **Federal Register
determination that product was not

A078773
A078773
A078773
A078773

001
002
003
004

May
May
May
May

29,
29,
29,
29,

2012
2012
2012
2012

N200153 001 May 03, 2013

N200153 002 May 03, 2013

N200153 003 May 03, 2013

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-39(of 347)

DISCONTINUED DRUG PRODUCT LIST

ATORVASTATIN CALCIUM; EZETIMIBE

TABLET;ORAL

LIPTRUZET

discontinued or withdrawn for safety or

efficacy reasons**

EQ 80MG BASE;10MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

ATOVAQUONE

TABLET;ORAL

MEPRON

GLAXOSMITHKLINE LLC

250MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

ATRACURIUM BESYLATE

INJECTABLE;INJECTION

ATRACURIUM BESYLATE

BAXTER HLTHCARE

BAXTER HLTHCARE CORP

HOSPIRA

10MG/ML

10MG/ML

10MG/ML

10MG/ML

TEVA PARENTERAL

10MG/ML

WATSON LABS INC

10MG/ML

ATRACURIUM BESYLATE PRESERVATIVE FREE

BAXTER HLTHCARE

10MG/ML

BAXTER HLTHCARE CORP

10MG/ML

HOSPIRA

10MG/ML

10MG/ML

10MG/ML

WATSON LABS INC

10MG/ML

TRACRIUM

HOSPIRA

10MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

TRACRIUM PRESERVATIVE FREE

HOSPIRA

10MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N200153 004
May 03, 2013

N020259 001
Nov 25, 1992

A074824
A074753
A074632
A074740
A074784
A074945

001

001

001

001

001

001

Sep
Jan
Dec
Mar
Jun
Jul

30,
23,
23,
28,
11,
28,

1997

1997

1996

1997

1997

1998

A074825
A074768
A074633
A074639
A074741
A074944

001

001

001

001

001

001

Sep
Jan
Dec
Mar
Mar
Jul

30,
23,
23,
25,
28,
28,

1997

1997

1996

1997

1997

1998

N018831 002
Jun 20, 1985

N018831 001
Nov 23, 1983

ATROPINE

INJECTABLE;INJECTION

ATROPINE

ABBVIE

EQ 2MG SULFATE/0.7ML

A071295 001
Jan 30, 1987

ATROPINE SULFATE

AEROSOL, METERED;INHALATION

ATROPINE SULFATE

US ARMY

EQ 0.36MG BASE/INH

N020056 001
Sep 19, 1990

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

TABLET;ORAL

MOTOFEN HALF-STRENGTH

SEBELA IRELAND LTD
0.025MG;0.5MG

ATROPINE SULFATE; DIPHENOXYLATE
CAPSULE;ORAL

DIPHENOXYLATE HYDROCHLORIDE
SCHERER RP

SOLUTION;ORAL

COLONAID

MEDPOINTE PHARM HLC

LOMANATE

ALPHARMA US PHARMS

LOMOTIL

GD SEARLE LLC

TABLET;ORAL

COLONAID

MEDPOINTE PHARM HLC

DI-ATRO

MD PHARM

N017744 001

HYDROCHLORIDE

W/ ATROPINE SULFATE

0.025MG;2.5MG

A086440 001

0.025MG/5ML;2.5MG/5ML

A085735 001

0.025MG/5ML;2.5MG/5ML

A085746 001

0.025MG/5ML;2.5MG/5ML

N012699 001

0.025MG;2.5MG

A085737 001

0.025MG;2.5MG

A085266 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-40(of 347)

DISCONTINUED DRUG PRODUCT LIST

ATROPINE SULFATE; DIPHENOXYLATE
TABLET;ORAL

DIPHENOXYLATE HYDROCHLORIDE
ABLE

ANI PHARMS INC

ASCOT

HEATHER

HIKMA PHARMS LLC

INWOOD LABS

KV PHARM

LEDERLE

MUTUAL PHARM

PARKE DAVIS

PVT FORM

R AND S PHARMA

ROXANE

SANDOZ

USL PHARMA

VALEANT PHARM INTL

WATSON LABS

LO-TROL

VANGARD

LOGEN

SUPERPHARM

LOW-QUEL

HALSEY

HYDROCHLORIDE

AND ATROPINE SULFATE

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

0.025MG;2.5MG

A040395
A086727
A087934
A086798
A087765
A085509
A085659
A086950
A085506
A087131
A085766
A085035
A086057
A086173
A087842
A087195
A085876

0.025MG;2.5MG

A088009 001 Mar 25, 1983

0.025MG;2.5MG

A088962 001 May 10, 1985

0.025MG;2.5MG

A085211 001

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

INJECTABLE;INJECTION

ENLON-PLUS

MYLAN INSTITUTIONAL
0.14MG/ML;10MG/ML

ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

ATROPINE AND DEMEROL

ABBVIE
0.4MG/ML;50MG/ML

0.4MG/ML;75MG/ML

0.4MG/ML;100MG/ML

MEPERIDINE AND ATROPINE SULFATE

WYETH AYERST
0.4MG/ML;50MG/ML

0.4MG/ML;75MG/ML

0.4MG/ML;100MG/ML

001
001

001
001

001
001

001

001

001

001

001

001

001

001

001
001
001

Nov 27, 2000

Jul 19, 1983

Mar 15, 1982

Mar 29, 1982

Feb 16, 1982

N019677 001 Nov 06, 1991

A087853 001 Nov 26, 1982

A087847 001 Nov 26, 1982

A087848 001 Nov 26, 1982

A085121 001

A085121 002

A085121 003

ATROPINE; PRALIDOXIME CHLORIDE

INJECTABLE;INTRAMUSCULAR

ATNAA

US ARMY
2.1MG/0.7ML;600MG/0.7ML;600MG/0.7ML

N021175 001 Jan 17, 2002

AZATADINE MALEATE

TABLET;ORAL

OPTIMINE

SCHERING

N017601 001

1MG

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

TRINALIN

SCHERING

1MG;120MG

N018506 001 Mar 23, 1982

AZATHIOPRINE

TABLET;ORAL

IMURAN

PROMETHEUS LABS

25MG

N016324 002

AZATHIOPRINE SODIUM

INJECTABLE;INJECTION

IMURAN

PROMETHEUS LABS

EQ 100MG BASE/VIAL

N017391 001

AZELASTINE HYDROCHLORIDE

SPRAY, METERED;NASAL

ASTEPRO

MEDA PHARMS

EQ 0.125MG BASE/SPRAY

N022203 001 Oct 15, 2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-41(of 347)

DISCONTINUED DRUG PRODUCT LIST

AZITHROMYCIN

CAPSULE;ORAL

ZITHROMAX

PFIZER

FOR SUSPENSION;ORAL

AZITHROMYCIN

SANDOZ

INJECTABLE;INJECTION

AZITHROMYCIN

PLIVA HRVATSKA DOO

TEVA PARENTERAL

EQ 250MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N050670 001
Nov 01, 1991

EQ 100MG BASE/5ML

EQ 200MG BASE/5ML

A065297 001
Sep 18, 2006

A065297 002
Sep 18, 2006

EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 2.5GM BASE/VIAL

A065265 001
Jan 18, 2007

N050809 001
Dec 19, 2006

N050809 002
Dec 19, 2006

AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE

FOR SUSPENSION, TABLET;ORAL

TROVAN/ZITHROMAX COMPLIANCE PAK

PFIZER

EQ 1GM BASE,N/A;N/A,EQ 100MG BASE

AZLOCILLIN SODIUM

INJECTABLE;INJECTION

AZLIN

BAYER PHARMS

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2GM
2GM
2GM
3GM
3GM
3GM
4GM
4GM
4GM

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

AZTREONAM

INJECTABLE;INJECTION

AZACTAM

BRISTOL MYERS SQUIBB
500MG/VIAL

AZACTAM IN PLASTIC CONTAINER

BRISTOL MYERS SQUIBB
10MG/ML

BACAMPICILLIN HYDROCHLORIDE

FOR SUSPENSION;ORAL

SPECTROBID

PFIZER

TABLET;ORAL

SPECTROBID

PFIZER

BACITRACIN

INJECTABLE;INJECTION

BACITRACIN

PFIZER

OINTMENT;OPHTHALMIC

BACIGUENT

PHARMACIA AND UPJOHN

BACITRACIN

LILLY

PHARMADERM

PHARMAFAIR

OINTMENT;TOPICAL

BACITRACIN

COMBE

NASKA

POWDER;FOR RX COMPOUNDING

BACI-RX

X GEN PHARMS

BACITRACIN

APOTHEKERNES

PADDOCK LLC

N050762 001
Dec 18, 1998

A062388
A062417
N050562
A062388
A062417
N050562
A062388
A062417
N050562

001

001

001

002

002

002

003

003

003

Sep
Oct
Sep
Sep
Oct
Sep
Sep
Oct
Sep

08,
12,
03,
08,
12,
03,
08,
12,
03,

1982

1982

1982

1982

1982

1982

1982

1982

1982

N050580 001
Dec 31, 1986

N050632 003
May 24, 1989

125MG/5ML

N050556 001
Mar 23, 1982

400MG

800MG

N050520 001

N050520 002
Sep 12, 1983

50,000 UNITS/VIAL

A060282 001

500 UNITS/GM

A060734 001

500 UNITS/GM

500 UNITS/GM

500 UNITS/GM

A060687 001

A062158 001

A062453 001
Mar 28, 1984

500 UNITS/GM

500 UNITS/GM

A062799 001
May 14, 1987

A062857 001
Nov 13, 1987

5,000,000 UNITS/BOT

A061580 001

5,000,000 UNITS/BOT

5,000,000 UNITS/BOT

A061699 001

A062456 001
Jul 27, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-42(of 347)

DISCONTINUED DRUG PRODUCT LIST

BACITRACIN ZINC

POWDER;FOR RX COMPOUNDING

ZIBA-RX

X GEN PHARMS

500,000 UNITS/BOT

A061737 001

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

CORTISPORIN

CITRON PHARMA LLC
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000

N050416 002

UNITS/GM

ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE

PHARMAFAIR
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000

A062389 001
Jul 02, 1982

UNITS/GM

OINTMENT;TOPICAL

NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE

PHARMAFAIR
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000

A062381 001
Sep 06, 1985

UNITS/GM

BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;TOPICAL

LANABIOTIC

COMBE
400 UNITS/GM;40MG/GM;EQ 5MG

BASE/GM;5,000 UNITS/GM

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE

PHARMAFAIR
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000

UNITS/GM

BACITRACIN-NEOMYCIN-POLYMYXIN

PHARMADERM
400 UNITS/GM;EQ 3.5MG BASE/GM;5,000

UNITS/GM

NEO-POLYCIN

DOW PHARM
500 UNITS/GM;EQ 3.5MG BASE/GM;10,000

UNITS/GM

NEOSPORIN

CITRON PHARMA LLC
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000

UNITS/GM

OINTMENT;TOPICAL

BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE

NASKA
400 UNITS/GM;EQ 3.5MG BASE/GM;5,000

UNITS/GM

BACITRACIN ZINC; POLYMYXIN B SULFATE

AEROSOL;TOPICAL

POLYSPORIN

GLAXOSMITHKLINE
10,000 UNITS/GM;2,000,000 UNITS/GM

OINTMENT;OPHTHALMIC

OCUMYCIN

PHARMAFAIR
500 UNITS/GM;10,000 UNITS/GM

POLYSPORIN

MONARCH PHARMS
500 UNITS/GM;10,000 UNITS/GM

OINTMENT;TOPICAL

BACITRACIN ZINC-POLYMYXIN B SULFATE

NASKA
500 UNITS/GM;10,000 UNITS/GM

A062499 001
Jun 03, 1985

A062386 001
Sep 09, 1982

A062167 001

A060647 001

N050417 001

A062833 001
Nov 09, 1987

N050167 002
Mar 01, 1985

A062430 001
Apr 08, 1983

A061229 001

A062849 001
Nov 13, 1987

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

ALTANA
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000

A060731 002

UNITS/GM

BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

MYCITRACIN

PHARMACIA AND UPJOHN
500 UNITS/GM;EQ 3.5MG BASE/GM;10,000

UNITS/GM

BACITRACIN; POLYMYXIN B SULFATE

DISC;TOPICAL

LANABIOTIC

COMBE
500 UNITS/GM;5,000 UNITS/GM

A061048 001

N050598 001
Sep 22, 1986

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6-43(of 347)

DISCONTINUED DRUG PRODUCT LIST

BACLOFEN

TABLET;ORAL

BACLOFEN

TEVA
USL PHARMA
WATSON LABS

10MG

20MG

10MG

20MG

10MG

10MG

20MG

20MG

LIORESAL

NOVARTIS

10MG

20MG

TABLET, ORALLY DISINTEGRATING;ORAL

KEMSTRO

UCB INC

10MG

20MG

BECLOMETHASONE DIPROPIONATE

AEROSOL, METERED;INHALATION

BECLOVENT

GLAXOSMITHKLINE

VANCERIL

SCHERING

VANCERIL DOUBLE STRENGTH

SCHERING

AEROSOL, METERED;NASAL

BECONASE

GLAXOSMITHKLINE

VANCENASE

SCHERING

Feb
Feb
May
May
Jan
Aug
Jan
Aug

27,
27,
06,
06,
28,
20,
28,
20,

1992

1992

1988

1988

1994

1996

1994

1996

N017851 001

N017851 003 Jan 20, 1982

N021589 001 Oct 30, 2003

N021589 002 Oct 30, 2003

N018153 001

0.042MG/INH

N017573 001

0.084MG/INH

N020486 001 Dec 24, 1996

0.042MG/INH

N018584 001

0.042MG/INH

N018521 001

5MG

10MG

20MG

40MG

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

MYLAN PHARMS INC
5MG;6.25MG

10MG;12.5MG

20MG;12.5MG

20MG;25MG

BENDROFLUMETHIAZIDE

TABLET;ORAL

NATURETIN-10

APOTHECON
NATURETIN-2.5

APOTHECON
NATURETIN-5

APOTHECON

001
001
001
001
001
001
001
002

0.042MG/INH

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED;NASAL

VANCENASE AQ

SCHERING
EQ 0.042MG DIPROP/SPRAY

EQ 0.084MG DIPROP/SPRAY

BENAZEPRIL HYDROCHLORIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE

GENPHARM

A073043
A073044
A071260
A071261
A073092
A074698
A073093
A074698

N019589 001 Dec 23, 1987

N020469 001 Jun 26, 1996

A076476
A076476
A076476
A076476

001
002
003
004

Feb
Feb
Feb
Feb

11,
11,
11,
11,

2004

2004

2004

2004

A076612
A076612
A076612
A076612

001
002
003
004

Feb
Feb
Feb
Feb

11,
11,
11,
11,

2004

2004

2004

2004

10MG

N012164 003

2.5MG

N012164 001

5MG

N012164 002

BENOXINATE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

BENOXINATE HYDROCHLORIDE

SOLA BARNES HIND

0.4%

A084149 001

BENTIROMIDE

SOLUTION;ORAL

CHYMEX

SAVAGE LABS

500MG/7.5ML

N018366 001 Dec 29, 1983

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DISCONTINUED DRUG PRODUCT LIST

BENZONATATE
CAPSULE;ORAL
BENZONATATE
NESHER PHARMS
TESSALON
PFIZER

100MG
200MG

A040795 001 Oct 31, 2007

A040795 002 Oct 31, 2007

200MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N011210 003 Jun 25, 1999

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

GEL;TOPICAL
BENZACLIN
VALEANT BERMUDA
5%;EQ 1% BASE
BENZPHETAMINE HYDROCHLORIDE
TABLET;ORAL
BENZPHETAMINE HYDROCHLORIDE
COREPHARMA
50MG
DIDREX
PHARMACIA AND UPJOHN
25MG
50MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
BENZQUINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
EMETE-CON
PFIZER
SUPPOSITORY;RECTAL
EMETE-CON
ROERIG
BENZTHIAZIDE
TABLET;ORAL
AQUATAG
SOLVAY
BENZTHIAZIDE
PVT FORM
EXNA
AH ROBINS INC
FOVANE
PFIZER
URESE
PFIZER
BENZTROPINE MESYLATE
TABLET;ORAL
BENZTROPINE MESYLATE
LANNETT HOLDINGS INC

MUTUAL PHARM
PROSAM LABS

QUANTUM PHARMICS

USL PHARMA

COGENTIN
MERCK

N050756 002 Apr 20, 2007

A040714 001 Oct 29, 2007

N012427 003
N012427 002

EQ 50MG BASE/VIAL

N016820 001

EQ 100MG BASE

N016818 006

25MG
50MG

N016001 001
N016001 002

50MG

A083206 001

50MG

N012489 001

50MG

N012128 002

25MG

N012128 003

0.5MG
1MG
2MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG

A088877
A088894
A088895
A081264
A081265
A040699
A040705
A040706
A088514
A088510
A088511
A089211
A089212
A089213

0.5MG
1MG
2MG

N009193 004
N009193 003
N009193 002

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Apr
Apr
Apr
Jan
Jan
Feb
Feb
Feb
Jan
Jan
Jan
Jun
Jun
Jun

11,
11,
11,
23,
23,
14,
14,
14,
31,
31,
31,
14,
14,
14,

1985
1985
1985
1992
1992
2008
2008
2008
1984
1984
1984
1988
1988
1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-45(of 347)

DISCONTINUED DRUG PRODUCT LIST

BENZYL BENZOATE

EMULSION;TOPICAL

BENZYL BENZOATE

LANNETT

BEPRIDIL HYDROCHLORIDE

TABLET;ORAL

BEPADIN

MEDPOINTE PHARM HLC

VASCOR

JOHNSON AND JOHNSON

BETA CAROTENE

CAPSULE;ORAL

SOLATENE

ROCHE

BETAMETHASONE

CREAM;TOPICAL

CELESTONE

SCHERING

SYRUP;ORAL

CELESTONE

MERCK SHARP DOHME

TABLET;ORAL

CELESTONE

SCHERING

BETAMETHASONE BENZOATE

CREAM;TOPICAL

UTICORT

PARKE DAVIS

GEL;TOPICAL

UTICORT

PARKE DAVIS

LOTION;TOPICAL

UTICORT

PARKE DAVIS

OINTMENT;TOPICAL

UTICORT

PARKE DAVIS

50%

A084535 001

200MG

300MG

400MG

N019001 001 Dec 28, 1990

N019001 002 Dec 28, 1990

N019001 003 Dec 28, 1990

200MG

300MG

400MG

N019002 001 Dec 28, 1990

N019002 002 Dec 28, 1990

N019002 003 Dec 28, 1990

30MG

N017589 001

0.2%

N014762 001

0.6MG/5ML

N014215 002

0.6MG

N012657 003

0.025%

N016998 002

0.025%

N017244 001

0.025%

N017528 001

0.025%

N018089 001

BETAMETHASONE DIPROPIONATE

CREAM;TOPICAL

ALPHATREX

SAVAGE LABS

EQ 0.05% BASE

BETAMETHASONE DIPROPIONATE

PERRIGO NEW YORK

EQ 0.05% BASE

EQ 0.05% BASE

PHARMADERM

EQ 0.05% BASE

TARO

EQ 0.05% BASE

TEVA

EQ 0.05% BASE

DIPROSONE

SCHERING

EQ 0.05% BASE

CREAM, AUGMENTED;TOPICAL

DIPROLENE

SCHERING

EQ 0.05% BASE

DISC;TOPICAL

DIPROSONE

SCHERING

EQ 0.1% BASE

GEL, AUGMENTED;TOPICAL

DIPROLENE

SCHERING

EQ 0.05% BASE

LOTION;TOPICAL

ALPHATREX

SAVAGE LABS

EQ 0.05% BASE

BETAMETHASONE DIPROPIONATE

ALPHARMA US PHARMS

EQ 0.05% BASE

G AND W LABS INC

EQ 0.05% BASE

PHARMADERM

EQ 0.05% BASE

TARO

EQ 0.05% BASE

N019138 001 Jun 26, 1984

A072536
A074579
N019136
A071143
A071476

001
001
001
001
001

Jan
Nov
Jun
Jun
Aug

31,
26,
26,
17,
10,

1990

1997

1984

1987

1987

N017536 001

N019408 001 Jan 31, 1986

N017829 001

N019408 002 Nov 22, 1991

A070273 001 Aug 12, 1985

A071085
A071882
A070274
A072276

001
001
001
001

Feb
Jun
Aug
Aug

03,
06,
12,
24,

1987

1988

1985

1988

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BETAMETHASONE DIPROPIONATE
LOTION;TOPICAL
BETAMETHASONE DIPROPIONATE
DIPROSONE
SCHERING
OINTMENT;TOPICAL
ALPHATREX
SAVAGE LABS
BETAMETHASONE DIPROPIONATE
PERRIGO NEW YORK
PHARMADERM
TEVA
DIPROSONE
SCHERING

EQ 0.05% BASE

A074272 001 Sep 30, 1994

EQ 0.05% BASE

N017781 001

EQ 0.05% BASE

N019143 001 Sep 04, 1984

EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE

A072526 001 Jan 31, 1990

N019140 001 Sep 04, 1984
A071477 001 Aug 10, 1987

EQ 0.05% BASE

N017691 001

BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION
BETAMETHASONE SODIUM PHOSPHATE
WATSON LABS
EQ 3MG BASE/ML
CELESTONE
SCHERING
EQ 3MG BASE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
BETAMETHASONE VALERATE
CREAM;TOPICAL
BETADERM
ROACO
BETAMETHASONE VALERATE
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
TARO
BETATREX
SAVAGE LABS
VALISONE
SCHERING
LOTION;TOPICAL
BETAMETHASONE VALERATE
PHARMADERM
PHARMAFAIR
TEVA PHARMS
BETATREX
SAVAGE LABS
VALISONE
SCHERING
OINTMENT;TOPICAL
BETAMETHASONE VALERATE
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
BETATREX
SAVAGE LABS
VALISONE
SCHERING
BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
BETAXOLOL HYDROCHLORIDE
APOTEX INC
TABLET;ORAL
KERLONE
SANOFI AVENTIS US

A085738 001
N017561 001

EQ 0.1% BASE

N018839 001 Jun 30, 1983

EQ
EQ
EQ
EQ

A070053
N018860
A070485
A070062

0.1%
0.1%
0.1%
0.1%

BASE
BASE
BASE
BASE

001
002
001
001

Jun
Aug
May
May

10,
31,
29,
14,

1986
1983
1987
1985

EQ 0.1% BASE

N018862 001 Aug 31, 1983

EQ 0.01% BASE
EQ 0.1% BASE

N016322 002
N016322 001

EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE

N018870 001 Aug 31, 1983

A070484 001 May 29, 1987
A071883 001 Apr 22, 1988

EQ 0.1% BASE

N018867 001 Aug 31, 1983

EQ 0.1% BASE

N016932 001

EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE

A071478 001 Dec 23, 1987

N018864 001 Aug 31, 1983
A070486 001 May 29, 1987

EQ 0.1% BASE

N018863 001 Aug 31, 1983

EQ 0.1% BASE

N016740 001

EQ 0.5% BASE

A075446 001 Sep 28, 2000

10MG
20MG

N019507 001 Oct 27, 1989

N019507 002 Oct 27, 1989

BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

TABLET;ORAL
KERLEDEX
SANOFI AVENTIS US
5MG;12.5MG
10MG;12.5MG

N019807 001 Oct 30, 1992

N019807 002 Oct 30, 1992

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6-47(of 347)

DISCONTINUED DRUG PRODUCT LIST

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
BETOPTIC PILO
ALCON
EQ 0.25% BASE;1.75%

N020619 001 Apr 17, 1997

BETAZOLE HYDROCHLORIDE
INJECTABLE;INJECTION
HISTALOG
LILLY

50MG/ML

N009344 001

5MG/ML **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N006536 001

5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
10MG
25MG
25MG
5MG
10MG
25MG
5MG
10MG
10MG
25MG
25MG
5MG
5MG
5MG
10MG
10MG
10MG
25MG
25MG
25MG
50MG
50MG

A040492
A040483
A040485
A040509
A040552
A040553
A040554
A040551
A088288
A088289
A084689
A084702
A084712
A084074
A084353
A084378
A084379
A084383
A084384
A084402
A085230
A085841
A084408
A085228
A085842
A084441
A085229
A085839
A087397
A087444

5MG
10MG
25MG

A084188 001
A084188 003
A084188 004

5MG
10MG
25MG
50MG

N006536
N006536
N006536
N006536

10MG
25MG

N017675 001
N017675 002

50MG
50MG
50MG

A077995 001 Jul 06, 2009

A078285 001 Mar 24, 2011
A077973 001 Jul 06, 2009

BETHANECHOL CHLORIDE
INJECTABLE;INJECTION
URECHOLINE
ODYSSEY PHARMS

TABLET;ORAL
BETHANECHOL CHLORIDE
ABLE

ACTAVIS ELIZABETH

ASCOT
IVAX SUB TEVA PHARMS
LANNETT

SANDOZ

WATSON LABS

MYOTONACHOL
GLENWOOD

URECHOLINE
ODYSSEY PHARMS

BETHANIDINE SULFATE
TABLET;ORAL
TENATHAN
ROBINS AH
BICALUTAMIDE
TABLET;ORAL
BICALUTAMIDE
KUDCO IRELAND
ROXANE
SYNTHON PHARMS

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001

Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Jun
Jun

27,
27,
27,
27,
28,
28,
28,
28,
08,
08,

2004
2004
2004
2004
2004
2004
2004
2004
1983
1983

003
002
004
005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-48(of 347)

DISCONTINUED DRUG PRODUCT LIST

BIMATOPROST
SOLUTION/DROPS;OPHTHALMIC
LUMIGAN
ALLERGAN

0.03% **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N021275 001 Mar 16, 2001

BIPERIDEN HYDROCHLORIDE
TABLET;ORAL
AKINETON
ABBVIE

2MG

N012003 001

BIPERIDEN LACTATE
INJECTABLE;INJECTION
AKINETON
ABBVIE

5MG/ML

N012418 002

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL

HALFLYTELY

BRAINTREE
5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM
N021551 003 Jul 16, 2010

;N/A,5.6GM **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

TABLET, CHEWABLE, TABLET, CAPSULE;ORAL

HELIDAC

PROMETHEUS LABS
262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,5
00MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

BISOPROLOL FUMARATE

TABLET;ORAL

BISOPROLOL FUMARATE

MUTUAL PHARM

5MG
10MG

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

ACTAVIS ELIZABETH
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
APOTHECON
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
IVAX SUB TEVA PHARMS 2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
SANDOZ
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
TEVA
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
WATSON LABS
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
BITOLTEROL MESYLATE

AEROSOL, METERED;INHALATION

TORNALATE

SANOFI AVENTIS US
SOLUTION;INHALATION

TORNALATE

SANOFI AVENTIS US

N050719 001 Aug 15, 1996

A075474 001 Oct 25, 2002

A075474 002 Oct 25, 2002

A075672
A075672
A075672
A075642
A075642
A075642
A075632
A075632
A075632
A075527
A075527
A075527
A075686
A075686
A075686
A075469
A075469
A075469

001
002
003
002
001
003
001
002
003
001
003
002
001
002
003
001
002
003

Sep
Sep
Sep
Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep
Jan
Jan
Jan
Sep
Sep
Sep

25,
25,
25,
27,
27,
27,
27,
27,
27,
25,
25,
25,
19,
19,
19,
25,
25,
25,

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2001

2001

2001

2000

2000

2000

0.37MG/INH

N018770 001 Dec 28, 1984

0.2%

N019548 001 Feb 19, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-49(of 347)

DISCONTINUED DRUG PRODUCT LIST

BLEOMYCIN SULFATE
INJECTABLE;INJECTION
BLENOXANE
BRISTOL MYERS SQUIBB
BLEOMYCIN SULFATE
PHARMACHEMIE BV
TEVA PARENTERAL

EQ 15 UNITS BASE/VIAL
EQ 30 UNITS BASE/VIAL

N050443 001
N050443 002 Sep 07, 1995

EQ 15 UNITS BASE/VIAL
EQ 15 UNITS BASE/VIAL
EQ 30 UNITS BASE/VIAL

A065201 001 Dec 13, 2007

A064084 001 Jun 01, 1996
A064084 002 Jun 01, 1996

BRETYLIUM TOSYLATE
INJECTABLE;INJECTION
BRETYLIUM TOSYLATE
ABRAXIS PHARM

50MG/ML
100MG/ML
ASTRAZENECA
50MG/ML
50MG/ML
50MG/ML
HIKMA MAPLE
50MG/ML
50MG/ML
HOSPIRA
50MG/ML
50MG/ML
INTL MEDICATION
50MG/ML
LUITPOLD
50MG/ML
BRETYLIUM TOSYLATE IN DEXTROSE 5%
ABBOTT
200MG/100ML
400MG/100ML
800MG/100ML
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
200MG/100ML
400MG/100ML
HOSPIRA INC
200MG/100ML
400MG/100ML
800MG/100ML
BRETYLOL
HOSPIRA
50MG/ML

BRIMONIDINE TARTRATE
SOLUTION/DROPS;OPHTHALMIC
ALPHAGAN
ALLERGAN
BRIMONIDINE TARTRATE
TEVA PARENTERAL
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
BROMDAY
BAUSCH AND LOMB INC

XIBROM
BAUSCH AND LOMB INC
BROMOCRIPTINE MESYLATE
CAPSULE;ORAL
BROMOCRIPTINE MESYLATE
LEK PHARM

A070134
A071298
A071151
A071152
A071153
A070545
A070546
N019030
N019033
A070119
A070891

001
001
001
001
001
001
001
001
001
001
001

Apr
Feb
Aug
Aug
Aug
May
May
Apr
Apr
Apr
Jul

29,
13,
10,
10,
10,
14,
14,
29,
29,
29,
26,

1986
1987
1987
1987
1987
1986
1986
1986
1986
1986
1988

N019005 002 Apr 29, 1986

N019005 003 Apr 29, 1986
N019005 001 Apr 29, 1986
N019837
N019837
N019008
N019008
N019008

002
001
002
003
001

Apr
Apr
Apr
Apr
Apr

12,
12,
29,
29,
29,

1989
1989
1986
1986
1986

N017954 001

0.2%
0.5%

N020613 001 Sep 06, 1996

N020490 001 Mar 13, 1997

0.2%

A076372 001 Sep 10, 2004

EQ 0.09% ACID **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N021664 002 Oct 16, 2010

EQ 0.09% ACID

N021664 001 Mar 24, 2005

EQ 5MG BASE

A075100 001 Dec 10, 1998

BROMODIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
AMBODRYL
PARKE DAVIS
25MG
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE
SYRUP;ORAL
AMBENYL
FOREST LABS
12.5MG/5ML;10MG/5ML
BROMANYL
ALPHARMA US PHARMS
12.5MG/5ML;10MG/5ML
BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE
WOCKHARDT
12.5MG/5ML;10MG/5ML

N007984 001

N009319 006 Jan 10, 1984

A088343 001 Aug 15, 1984
A088626 001 Oct 12, 1984

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BROMPHENIRAMINE MALEATE

ELIXIR;ORAL

BROMPHENIRAMINE MALEATE

ALPHARMA US PHARMS
KV PHARM
PHARM ASSOC
USL PHARMA
INJECTABLE;INJECTION

BROMPHENIRAMINE MALEATE

WATSON LABS
DIMETANE-TEN

WYETH AYERST
TABLET;ORAL

BROMPHENIRAMINE MALEATE

BARR
IVAX SUB TEVA PHARMS
NEWTRON PHARMS
NEXGEN PHARMA INC
PAR PHARM
PIONEER PHARMS
SANDOZ
VITARINE
WATSON LABS

2MG/5ML
2MG/5ML
2MG/5ML
2MG/5ML

A086936
A085466
A087517
A087964

10MG/ML
100MG/ML

A083821 001

A083820 001

10MG/ML

N011418 002

4MG
4MG
4MG
4MG
4MG
4MG
4MG
4MG
4MG
4MG

A084468
A084351
A086987
A086187
A087009
A088604
A083215
A085850
A083123
A085769

DIMETANE

WYETH CONS
4MG
TABLET, EXTENDED RELEASE;ORAL

DIMETANE

WYETH CONS
8MG
12MG

001

001

001

001 Jan 25, 1983

001

001

001

001

001

001 Jul 13, 1984

001

001

001

001

N010799 003

N010799 010 Jun 10, 1983

N010799 011 Jun 10, 1983

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP;ORAL

BROMANATE DM

ALPHARMA US PHARMS
2MG/5ML;10MG/5ML;30MG/5ML
A088722 001 Mar 07, 1985

BROMFED-DM

WOCKHARDT
2MG/5ML;10MG/5ML;30MG/5ML
A089681 001 Dec 22, 1988

DIMETANE-DX

ROBINS AH
2MG/5ML;10MG/5ML;30MG/5ML
N019279 001 Aug 24, 1984

BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

ALZA
16MG;240MG

N019672 001 Mar 29, 1996

BUCLIZINE HYDROCHLORIDE

TABLET;ORAL

BUCLADIN-S

STUART PHARMS

50MG

N010911 006

0.032MG/INH

N020233 001 Feb 14, 1994

0.16MG/INH
0.32MG/INH

N020441 002 Jun 24, 1997

N020441 003 Jun 24, 1997

0.25MG/2ML
0.5MG/2ML

A078202 001 Mar 30, 2009

A078202 002 Mar 30, 2009

0.25MG/ML
0.25MG/ML

A074160 001 Oct 30, 1997

A074613 001 Nov 18, 1997

0.25MG/ML

N018226 001 Feb 28, 1983

BUDESONIDE

AEROSOL, METERED;NASAL

RHINOCORT

ASTRAZENECA
POWDER, METERED;INHALATION

PULMICORT

ASTRAZENECA
SUSPENSION;INHALATION

BUDESONIDE

APOTEX INC
BUMETANIDE

INJECTABLE;INJECTION

BUMETANIDE

HOSPIRA
TEVA PARENTERAL
BUMEX

VALIDUS PHARMS INC

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BUPIVACAINE
INJECTABLE, LIPOSOMAL;INJECTION
EXPAREL
PACIRA PHARMS INC
133MG/10ML (13.3MG/ML)

N022496 001 Oct 28, 2011

BUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE
HOSPIRA
0.75%
BUPIVACAINE HYDROCHLORIDE KIT
HOSPIRA
0.075%
0.114%
0.23%
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATED
0.25%
0.5%
0.75%

A076012 001 Jan 09, 2002

A076012 002 Jan 09, 2002
A076012 003 Jan 09, 2002

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
HOSPIRA
0.25%;0.005MG/ML
0.5%;0.005MG/ML
0.75%;0.005MG/ML

A071166 001 Jun 16, 1988

A071169 001 Jun 16, 1988
A071171 001 Jun 16, 1988

BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION
DUOCAINE
AMPHASTAR PHARMS INC
EQ 0.375% (37.5MG/10ML);EQ 1%
(100MG/10ML)
BUPRENORPHINE HYDROCHLORIDE
TABLET;SUBLINGUAL
SUBUTEX
INDIVIOR INC

EQ 2MG BASE **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 8MG BASE **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

TABLET;SUBLINGUAL
SUBOXONE
INDIVIOR INC
EQ 2MG BASE;EQ 0.5MG BASE
EQ 8MG BASE;EQ 2MG BASE
BUPROPION HYDROCHLORIDE
TABLET;ORAL
BUPROPION HYDROCHLORIDE
SANDOZ
TEVA
WELLBUTRIN
GLAXOSMITHKLINE
TABLET, EXTENDED RELEASE;ORAL
BUPROPION HYDROCHLORIDE
ACTAVIS LABS FL INC
IMPAX LABS
SANDOZ

WOCKHARDT LTD

WELLBUTRIN SR
GLAXOSMITHKLINE
ZYBAN
GLAXOSMITHKLINE

A070587 001 Mar 03, 1987

N019978 001 Sep 03, 1992
N019978 002 Sep 03, 1992
N019978 003 Sep 03, 1992

N021496 001 May 23, 2003

N020732 002 Oct 08, 2002

N020732 003 Oct 08, 2002

N020733 001 Oct 08, 2002

N020733 002 Oct 08, 2002

75MG
100MG
75MG
100MG

A075613
A075613
A075310
A075310

002
001
001
002

50MG

N018644 001 Dec 30, 1985

300MG
300MG
100MG
150MG
150MG
100MG
150MG
200MG

A077715
A077415
A076845
A076834
A076845
A201331
A201331
A201331

50MG

N020358 001 Oct 04, 1996

100MG

N020711 002 May 14, 1997

002
002
001
001
002
001
002
003

Oct
Oct
Nov
Nov

Jun
Dec
Jul
Jul
Jul
Aug
Aug
Aug

10,
10,
29,
29,

13,
15,
14,
14,
14,
30,
30,
30,

2000
2000
1999
1999

2007
2006
2005
2005
2005
2012
2012
2012

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BUSPIRONE HYDROCHLORIDE
CAPSULE;ORAL
BUSPAR
BRISTOL MYERS SQUIBB

TABLET;ORAL
BUSPAR
BRISTOL MYERS SQUIBB

BUSPIRONE HYDROCHLORIDE
APOTEX

EGIS

IVAX SUB TEVA PHARMS

NESHER PHARMS

PROSAM LABS

SANDOZ

BUTABARBITAL SODIUM
CAPSULE;ORAL
BUTICAPS
MEDPOINTE PHARM HLC

ELIXIR;ORAL
BUTABARB
ALPHARMA US PHARMS
BUTABARBITAL SODIUM
WOCKHARDT
BUTALAN
LANNETT
BUTISOL SODIUM
MEDA PHARMS
SARISOL
HALSEY
TABLET;ORAL
BUTABARBITAL
BUNDY
BUTABARBITAL SODIUM
SANDOZ

SOLVAY

TEVA
WATSON LABS
WHITEWORTH TOWN PLSN
BUTISOL SODIUM
MEDA PHARMS

5MG
7.5MG
10MG
15MG

N021190
N021190
N021190
N021190

001
002
003
004

Dec
Dec
Dec
Dec

20,
20,
20,
20,

2000
2000
2000
2000

5MG
10MG
15MG
30MG

N018731
N018731
N018731
N018731

001
002
003
004

Sep
Sep
Apr
Apr

29,
29,
22,
22,

1986
1986
1996
1996

5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG

A075521
A075521
A075521
A075119
A075119
A075119
A075385
A075385
A075385
A075572
A075572
A075572
A075388
A075388
A075388
A075413
A075413
A075413

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Apr
Apr
Apr
Mar
Mar
Jan
Mar
Mar
Mar
Feb
Feb
Feb
May
May
May
Mar
Mar
Mar

05,
05,
05,
14,
14,
23,
01,
01,
01,
27,
27,
27,
09,
09,
09,
19,
19,
19,

2002
2002
2002
2002
2002
2003
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002

15MG
30MG
50MG
100MG

A085381
A085381
A085381
A085381

001
002
003
004

30MG/5ML

A085873 001

30MG/5ML

A085383 001

33.3MG/5ML

A085880 001

30MG/5ML

A085380 001

30MG/5ML

A084723 001

30MG

A085550 001

15MG
15MG
30MG
30MG
16.2MG
32.4MG
48.6MG
97.2MG
15MG
30MG
15MG
30MG
15MG
30MG

A084292
A085938
A084272
A085934
A083606
A083898
A083897
A083896
A088632
A088631
A085764
A085772
A083325
A083337

15MG
50MG
100MG

N000793 002
N000793 003
N000793 005

003 Feb 09, 1982

001
002
001
001
001
001
001
001 May 18, 1985
001 May 01, 1985
001
001
002
001

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BUTABARBITAL SODIUM

TABLET;ORAL

SARISOL NO. 1

HALSEY

SARISOL NO. 2

HALSEY

SODIUM BUTABARBITAL

HIKMA PHARMS LLC

IVAX SUB TEVA PHARMS

LANNETT

MARSHALL PHARMA

BUTENAFINE HYDROCHLORIDE

CREAM;TOPICAL

MENTAX-TC

MYLAN

BUTOCONAZOLE NITRATE

CREAM;VAGINAL

BUTOCONAZOLE NITRATE

ELAN PHARMA INTL LTD

FEMSTAT

ROCHE PALO

SUPPOSITORY;VAGINAL

FEMSTAT

ROCHE PALO

15MG

A084719 001

30MG

A084719 002

15MG

30MG

15MG

30MG

15MG

30MG

100MG

16.2MG

32.4MG

A085418
A085432
A083484
A084040
A085849
A085866
A085881
A083524
A083858

1%

N021408 001 Oct 17, 2002

2%

N019881 001 Feb 07, 1997

2%

N019215 001 Nov 25, 1985

100MG

N019359 001 Nov 25, 1985

BUTORPHANOL TARTRATE

INJECTABLE;INJECTION

BUTORPHANOL TARTRATE

APOTEX INC

HIKMA FARMACEUTICA

HOSPIRA

2MG/ML

2MG/ML

1MG/ML

1MG/ML

2MG/ML

2MG/ML

BUTORPHANOL TARTRATE PRESERVATIVE FREE

APOTEX INC

1MG/ML

2MG/ML

HOSPIRA

1MG/ML

1MG/ML

2MG/ML

2MG/ML

STADOL

APOTHECON

2MG/ML

STADOL PRESERVATIVE FREE

APOTHECON

1MG/ML

2MG/ML

SPRAY, METERED;NASAL

STADOL

BRISTOL MYERS SQUIBB
1MG/SPRAY

CABERGOLINE

TABLET;ORAL

DOSTINEX

PHARMACIA AND UPJOHN

CAFFEINE; ERGOTAMINE TARTRATE

SUPPOSITORY;RECTAL

CAFERGOT

NOVARTIS

TABLET;ORAL

CAFERGOT

NOVARTIS

WIGRAINE

ORGANON USA INC

001

001

001

001

001

001

001

001

001

A075697
A078247
A075342
A075559
A075342
A075559

001
001
001
001
002
002

Oct
Apr
Nov
Mar
Nov
Mar

23,
29,
04,
20,
04,
20,

2001

2009

1999

2000

1999

2000

A075695
A075695
A074620
A075170
A074620
A075170

001
002
001
001
002
002

Oct
Oct
Jan
Sep
Jan
Sep

23,
23,
22,
28,
22,
28,

2001

2001

1997

1998

1997

1998

N017857 004

N017857 001

N017857 002

N019890 001 Dec 12, 1991

0.5MG

N020664 001 Dec 23, 1996

100MG;2MG

N009000 002

100MG;1MG

N006620 001

100MG;1MG

A086562 001

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CALCIFEDIOL

CAPSULE;ORAL

CALDEROL

ORGANON USA INC
CALCIPOTRIENE

OINTMENT;TOPICAL

DOVONEX

LEO PHARMA AS
SOLUTION;TOPICAL

DOVONEX

LEO PHARM

CALCITONIN HUMAN

INJECTABLE;INJECTION

CIBACALCIN

NOVARTIS
CALCITONIN SALMON

INJECTABLE;INJECTION

CALCIMAR

SANOFI AVENTIS US
CALCITONIN-SALMON

IGI LABS INC
MIACALCIN

MYLAN IRELAND LTD
CALCITRIOL

INJECTABLE;INJECTION

CALCIJEX

ABBVIE
CALCITRIOL

AKORN
FRESENIUS KABI USA
FRESENIUS MEDCL
HOSPIRA
LUITPOLD
SAGENT PHARMS
TEVA PARENTERAL
CALCIUM ACETATE

CAPSULE;ORAL

PHOSLO

FRESENIUS MEDCL
TABLET;ORAL

CALCIUM ACETATE

ROXANE
PHOSLO

FRESENIUS MEDCL

0.02MG

0.05MG

N018312 001

N018312 002

0.005%

N020273 001
Dec 29, 1993

0.005% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N020611 001
Mar 03, 1997

0.5MG/VIAL

N018470 001
Oct 31, 1986

200 IU/ML

400 IU/VIAL

N017769 001

N017497 001

200 IU/ML

A073690 001
Apr 14, 1995

100 IU/ML

N017808 001
Jul 03, 1986

0.001MG/ML

0.002MG/ML

N018874 001
Sep 25, 1986

N018874 002
Sep 25, 1986

0.002MG/ML

0.001MG/ML

0.002MG/ML

0.001MG/ML

0.002MG/ML

0.001MG/ML

0.002MG/ML

0.001MG/ML

0.002MG/ML

0.001MG/ML

0.001MG/ML

0.002MG/ML

A078066
A075836
A075836
A075766
A075766
A075816
A075816
A075746
A075746
A077102
A075823
A075823

EQ 84.5MG CALCIUM

EQ 169MG CALCIUM

N021160 001
Apr 02, 2001

N021160 002
Apr 02, 2001

EQ 169MG CALCIUM

A077693 001
Jan 30, 2008

EQ 169MG CALCIUM

N019976 001
Dec 10, 1990

CALCIUM CARBONATE; RISEDRONATE SODIUM

TABLET, TABLET;ORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT
EQ 500MG BASE,N/A;N/A,35MG **Federal

Register determination that product was

not discontinued or withdrawn for

safety or efficacy reasons**

002

001

002

001

002

001

002

001

002

001

001

002

Jan
Dec
Dec
Feb
Feb
Jan
Jan
Sep
Sep
Feb
Mar
Mar

29,
31,
31,
20,
20,
16,
16,
26,
26,
08,
31,
31,

2008

2002

2002

2003

2003

2004

2004

2003

2003

2006

2003

2003

N021823 001
Aug 12, 2005

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM

BICARBONATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER

BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
N021703 012 Oct 10, 2008

3.05GM/1000ML;0.157GM/1000ML;2.21GM/100

0ML;7.07GM/1000ML (5000ML)

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DISCONTINUED DRUG PRODUCT LIST

6-55(of 347)

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM

BICARBONATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

PRISMASOL BGK 4/0 IN PLASTIC CONTAINER

BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0

N021703 005 Oct

5GM/1000ML;0.314GM/1000ML;3.09GM/1000ML

;6.46GM/1000ML (5000ML)

PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER

BAXTER HLTHCARE
5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;

N021703 008 Oct

2.03GM/1000ML;0.314GM/1000ML;3.09GM/100

0ML;6.46GM/1000ML (5000ML)

PRISMASOL BK 0/0 IN PLASTIC CONTAINER

BAXTER HLTHCARE
N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05

N021703 007 Oct

GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46

GM/1000ML (5000ML)

PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER

BAXTER HLTHCARE
3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3

N021703 009 Oct

.05GM/1000ML;0.314GM/1000ML;3.09GM/1000

ML;6.46GM/1000ML (5000ML)

25, 2006

25, 2006

25, 2006

25, 2006

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM

BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

SOLUTION;IRRIGATION

NAVSTEL

ALCON PHARMS LTD
0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/M
N022193 001 Jul 24, 2008

L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M

L

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

CHLORIDE

INJECTABLE;INJECTION

ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
37MG/100ML;5GM/100ML;31MG/100ML;120MG/1
N019864 001 Jun 10, 1993

00ML;330MG/100ML;88MG/100ML

ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
37MG/100ML;5GM/100ML;31MG/100ML;120MG/1
N018271 001

00ML;330MG/100ML;88MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM CITRATE

INJECTABLE;INJECTION

ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
35MG/100ML;5GM/100ML;30MG/100ML;74MG/10

N019867 001 Dec 20, 1993

0ML;640MG/100ML;500MG/100ML;74MG/100ML

ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
35MG/100ML;5GM/100ML;30MG/100ML;74MG/10

0ML;640MG/100ML;500MG/100ML;74MG/100ML

N018269 002 Jan 17, 1983

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
37MG/100ML;5GM/100ML;30MG/100ML;119MG/1
N017390 001

00ML;161MG/100ML;94MG/100ML;138MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

SOLUTION;INTRAPERITONEAL

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER

B BRAUN
29MG/100ML;2.5GM/100ML;15MG/100ML;610MG

N018460 006 Jan 29, 1986

/100ML;560MG/100ML

DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

B BRAUN
29MG/100ML;1.5GM/100ML;15MG/100ML;610MG

N018460 001

/100ML;560MG/100ML

DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

B BRAUN
29MG/100ML;4.25GM/100ML;15MG/100ML;610M

N018460 003

G/100ML;560MG/100ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION;INTRAPERITONEAL

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER

B BRAUN
26MG/100ML;1.5GM/100ML;15MG/100ML;560MG

N018460 002

/100ML;390MG/100ML

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER

B BRAUN
26MG/100ML;5GM/100ML;5MG/100ML;530MG/10

N018460 008 Jan 29, 1986

0ML;450MG/100ML

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER

B BRAUN
26MG/100ML;4.25GM/100ML;15MG/100ML;

N018460 004

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6-56(of 347)

DISCONTINUED DRUG PRODUCT LIST

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION;INTRAPERITONEAL

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER

560MG/100ML;390MG/100ML

INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

FRESENIUS
18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5

A020374
38MG/100ML;448MG/100ML

INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

FRESENIUS
18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5

A020374
38MG/100ML;448MG/100ML

INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

FRESENIUS
18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;5

A020374
38MG/100ML;448MG/100ML

INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

FRESENIUS
18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;

A020374
538MG/100ML;448MG/100ML

001
Jun 13, 1994

002
Jun 13, 1994

003
Jun 13, 1994

004
Jun 13, 1994

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER

B BRAUN
20MG/100ML;5GM/100ML;30MG/100ML;380MG/1
N018258 001

00ML;600MG/100ML

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER

B BRAUN
33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
00ML

BAXTER HLTHCARE
33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
00ML

N018256 001

N016695 001

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER

B BRAUN
4MG/100ML;4GM/100ML;6MG/100ML;120MG/100
N019634 002
Feb
ML;62MG/100ML

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER

B BRAUN
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
N017510 001

00ML;310MG/100ML

MILES
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
N018499 001

00ML;310MG/100ML

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

HOSPIRA
20MG/100ML;5GM/100ML;104MG/100ML;600MG/
N019685 005
Oct
100ML;310MG/100ML

20MG/100ML;5GM/100ML;179MG/100ML;600MG/
N019685 006
Oct
100ML;310MG/100ML

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

HOSPIRA
20MG/100ML;5GM/100ML;254MG/100ML;600MG/
N019685 007
Oct
100ML;310MG/100ML

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

HOSPIRA
20MG/100ML;5GM/100ML;254MG/100ML;600MG/
N019685 003
Oct
100ML;310MG/100ML

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

HOSPIRA
20MG/100ML;5GM/100ML;104MG/100ML;600MG/

N019685 001
Oct
100ML;310MG/100ML

CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION;INTRAPERITONEAL

INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

FRESENIUS MEDCL
25.7MG/100ML;1.5GM/100ML;538MG/100ML;44

8MG/100ML

INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

FRESENIUS MEDCL
25.7MG/100ML;2.5GM/100ML;538MG/100ML;44

8MG/100ML

INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

FRESENIUS MEDCL
25.7MG/100ML;4.25GM/100ML;538MG/100ML;4

48MG/100ML

24, 1988

17, 1988

17, 1988

17, 1988

17, 1988

17, 1988

N019395 001
Mar 26, 1986

N019395 002
Mar 26, 1986

N019395 003
Mar 26, 1986

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

TPN ELECTROLYTES IN PLASTIC CONTAINER

ABBOTT
16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;
N019399 001 Jun 16, 1986

16.1MG/ML

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6-57(of 347)

DISCONTINUED DRUG PRODUCT LIST

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM

CITRATE
INJECTABLE;INJECTION
ISOLYTE E IN PLASTIC CONTAINER
B BRAUN
35MG/100ML;30MG/100ML;74MG/100ML;640MG/
N018899 001 Oct 31, 1983
100ML;500MG/100ML;74MG/100ML
35MG/100ML;30MG/100ML;74MG/100ML;640MG/
N019718 001 Sep 29, 1989
100ML;500MG/100ML;74MG/100ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM

LACTATE

INJECTABLE;INJECTION

PLASMA-LYTE R IN PLASTIC CONTAINER

BAXTER HLTHCARE
36.8MG/100ML;30.5MG/100ML;74.6MG/100ML;

N017438 001

640MG/100ML;496MG/100ML;89.6MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

ACETATED RINGER'S IN PLASTIC CONTAINER

B BRAUN
20MG/100ML;30MG/100ML;380MG/100ML;600MG

/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

RINGER'S IN PLASTIC CONTAINER

B BRAUN
33MG/100ML;30MG/100ML;860MG/100ML

SOLUTION;IRRIGATION

RINGER'S IN PLASTIC CONTAINER

ABBOTT
33MG/100ML;30MG/100ML;860MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

LACTATED RINGER'S IN PLASTIC CONTAINER

ABBOTT
20MG/100ML;30MG/100ML;600MG/100ML;310MG

/100ML

B BRAUN
20MG/100ML;30MG/100ML;600MG/100ML;310MG

/100ML

MILES
20MG/100ML;30MG/100ML;600MG/100ML;310MG

/100ML

SOLUTION;IRRIGATION

LACTATED RINGER'S IN PLASTIC CONTAINER

BAXTER HLTHCARE

20MG/100ML;30MG/100ML;600MG/100ML;310MG

/100ML

CALCIUM GLUCEPTATE

INJECTABLE;INJECTION

CALCIUM GLUCEPTATE

ABBOTT

ABRAXIS PHARM

LILLY

EQ
EQ
EQ
EQ

90MG
90MG
90MG
90MG

CALCIUM/5ML

CALCIUM/5ML

CALCIUM/5ML

CALCIUM/5ML

N018725 001 Nov 29, 1982

N018721 001 Nov 09, 1982

N018462 001

N019485 001 Oct 24, 1985

N018023 001

N018417 001

N019933 001 Aug 29, 1989

A080001
A083159
A089373
N006470

001

001

001 Apr 30, 1987

001

CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM

INJECTABLE;INJECTION

ISOPAQUE 440

GE HEALTHCARE
0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML
N016847 001

CALCIUM; MEGLUMINE; METRIZOIC ACID

INJECTABLE;INJECTION

ISOPAQUE 280

GE HEALTHCARE

0.35MG/ML;140.1MG/ML;461.8MG/ML

CANDICIDIN

OINTMENT;VAGINAL

VANOBID

SANOFI AVENTIS US

TABLET;VAGINAL

VANOBID

SANOFI AVENTIS US

CAPTOPRIL

TABLET;ORAL

CAPOTEN

PAR PHARM

N017506 001

0.6MG/GM

A061596 001

3MG

A061613 001

12.5MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

25MG **Federal Register determination

that product was not discontinued or

N018343 005 Jan 17, 1985

N018343 002

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6-58(of 347)

DISCONTINUED DRUG PRODUCT LIST

CAPTOPRIL
TABLET;ORAL
CAPOTEN

CAPTOPRIL
APOTHECON

DAVA PHARMS INC

EGIS PHARMS

G AND W LABS INC

PAR PHARM

PRINSTON INC

PUREPAC PHARM

SANDOZ

VINTAGE PHARMS LLC

WATSON LABS

withdrawn for safety or efficacy

reasons**
37.5MG
50MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
75MG
100MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
150MG

N018343 004 Jun 13, 1995

12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
12.5MG
12.5MG
12.5MG
25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
100MG
100MG
100MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
12.5MG
25MG
25MG
50MG
50MG
100MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
12.5MG
25MG
25MG

A074472
A074472
A074472
A074472
A074423
A074423
A074423
A074423
A074748
A074748
A074748
A074748
A074433
A074462
A074483
A074590
A074433
A074462
A074483
A074590
A074433
A074462
A074483
A074590
A074433
A074462
A074483
A074590
A074493
A074493
A074493
A074493
A074477
A074477
A074477
A074477
A074640
A074640
A074640
A074640
A074481
A074519
A074481
A074519
A074481
A074519
A074481
A074519
A074418
A074418
A074418
A074418
A074451
A074576
A074451
A074576

N018343 006 Sep 17, 1986

N018343 001

N018343 007 Jun 13, 1995

N018343 003

001
002
003
004
001
002
003
004
004
002
001
003
001
001
001
004
002
002
002
002
003
003
003
001
004
004
004
003
001
002
003
004
001
002
003
004
001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004
001
001
002
002

Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
May
May
May
May
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Apr
Feb
Apr

31,
31,
31,
31,
13,
13,
13,
13,
29,
29,
29,
29,
13,
13,
13,
30,
13,
13,
13,
30,
13,
13,
13,
30,
13,
13,
13,
30,
13,
13,
13,
13,
13,
13,
13,
13,
31,
31,
31,
31,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
23,
13,
23,

1995
1995
1995
1995
1996
1996
1996
1996
1997
1997
1997
1997
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1997
1997
1997
1997
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-59(of 347)

DISCONTINUED DRUG PRODUCT LIST

CAPTOPRIL
TABLET;ORAL
CAPTOPRIL
50MG
50MG
100MG
100MG
CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
CAPOZIDE 25/15
APOTHECON
25MG;15MG **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
CAPOZIDE 25/25
APOTHECON
25MG;25MG **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
CAPOZIDE 50/15
APOTHECON
50MG;15MG **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
CAPOZIDE 50/25
APOTHECON
50MG;25MG **Federal Register
determination that product was not
discontinued or withdrawn for safety
efficacy reasons**
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS
25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG
VINTAGE PHARMS LLC
25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG
WATSON LABS
50MG;25MG
CARBACHOL
SOLUTION;INTRAOCULAR
CARBACHOL
PHARMAFAIR
CARBASTAT
NOVARTIS
CARBAMAZEPINE
SUSPENSION;ORAL
CARBAMAZEPINE
TARO
TABLET;ORAL
CARBAMAZEPINE
ACTAVIS ELIZABETH
INWOOD LABS
PLIVA
USL PHARMA
WARNER CHILCOTT
TERIL
TARO
TABLET, CHEWABLE;ORAL
CARBAMAZEPINE
JUBILANT CADISTA
CARBENICILLIN DISODIUM
INJECTABLE;INJECTION
GEOPEN
ROERIG

PYOPEN
GLAXOSMITHKLINE

A074451
A074576
A074451
A074576

003
003
004
004

Feb
Apr
Feb
Apr

13,
23,
13,
23,

1996
1996
1996
1996

N018709 001 Oct 12, 1984

or

N018709 002 Oct 12, 1984

or

N018709 004 Oct 12, 1984

or

N018709 003 Oct 12, 1984

or

A075055
A075055
A075055
A075055
A074788
A074788
A074788
A074788
A074832

001
002
004
003
001
002
004
003
001

Jun
Jun
Jun
Jun
Dec
Dec
Dec
Dec
Dec

18,
18,
18,
18,
29,
29,
29,
29,
29,

1998
1998
1998
1998
1997
1997
1997
1997
1997

0.01%

A070292 001 May 21, 1986

0.01%

A073677 001 Apr 28, 1995

100MG/5ML

A075875 001 Dec 21, 2000

200MG
200MG
200MG
200MG
200MG

A071696
A070231
A071479
A070300
A070429

200MG

A076525 001 Sep 26, 2003

100MG

A071940 001 Feb 01, 1988

EQ
EQ
EQ
EQ
EQ

N050306
N050306
N050306
N050306
N050306

1GM BASE/VIAL
2GM BASE/VIAL
5GM BASE/VIAL
10GM BASE/VIAL
30GM BASE/VIAL

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL

001
001
001
001
001

001
004
002
006
007

N050298 001
N050298 002

Nov
Aug
Jul
May
Jan

09,
14,
24,
15,
02,

1987
1986
1987
1986
1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-60(of 347)

DISCONTINUED DRUG PRODUCT LIST

CARBENICILLIN DISODIUM
INJECTABLE;INJECTION
PYOPEN

CARBENICILLIN INDANYL SODIUM

TABLET;ORAL
GEOCILLIN
PFIZER
CARBIDOPA; LEVODOPA
TABLET;ORAL
CARBIDOPA AND LEVODOPA
SANDOZ

SCS

WATSON LABS

EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL

N050298 003
N050298 006
N050298 007

EQ 382MG BASE

N050435 001

10MG;100MG
25MG;100MG
25MG;250MG
10MG;100MG
25MG;100MG
25MG;250MG
10MG;100MG
25MG;100MG
25MG;250MG

A073586
A073587
A073620
A074080
A074080
A074080
A073381
A073382
A073383

TABLET, EXTENDED RELEASE;ORAL

CARBIDOPA AND LEVODOPA
KV PHARM
50MG;200MG
TABLET, FOR SUSPENSION;ORAL
CARBILEV
RANBAXY
10MG;100MG
25MG;100MG
25MG;250MG
TABLET, ORALLY DISINTEGRATING;ORAL
CARBIDOPA AND LEVODOPA
IMPAX LABS
10MG;100MG
25MG;100MG
25MG;250MG
PARCOPA
UCB INC
10MG;100MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
25MG;100MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
25MG;250MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CARBINOXAMINE MALEATE
ELIXIR;ORAL
CLISTIN
MCNEIL

TABLET;ORAL
CLISTIN
ORTHO MCNEIL PHARM
CARBOPLATIN
INJECTABLE;INJECTION
CARBOPLATIN
CIPLA LTD

EUROHLTH INTL SARL

FRESENIUS KABI USA

HOSPIRA

001
001
001
001
002
003
001
001
001

Jun
Jun
Jun
Mar
Mar
Mar
Sep
Sep
Sep

29,
29,
29,
25,
25,
25,
28,
28,
28,

1995
1995
1995
1994
1994
1994
1993
1993
1993

A076663 001 Jun 24, 2004

A076643 001 Jun 10, 2005

A076643 002 Jun 10, 2005
A076643 003 Jun 10, 2005

A090631 001 Jun 08, 2010

A090631 002 Jun 08, 2010
A090631 003 Jun 08, 2010
A076699 001 Aug 27, 2004

A076699 002 Aug 27, 2004

A076699 003 Aug 27, 2004

4MG/5ML **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N008955 001

4MG

N008915 001

50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL

A077383
A077383
A077383
A076099
A076099
A076099
A076235
A076235
A076235
A076473
A076473

001
002
003
001
002
003
001
002
003
001
002

Jan
Jan
Jan
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

27,
27,
27,
14,
14,
14,
14,
14,
14,
27,
27,

2006
2006
2006
2004
2004
2004
2004
2004
2004
2004
2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-61(of 347)

DISCONTINUED DRUG PRODUCT LIST

CARBOPLATIN

INJECTABLE;INJECTION

CARBOPLATIN

MYLAN LABS LTD

PLIVA

SANDOZ

WATSON LABS

PARAPLATIN

CORDEN PHARMA

INJECTABLE;IV (INFUSION)

CARBOPLATIN

FRESENIUS KABI USA

PHARMACHEMIE BV

TEVA PARENTERAL

PARAPLATIN

CORDENPHARMA

CARISOPRODOL

CAPSULE;ORAL

SOMA

MEDA PHARMS
TABLET;ORAL

CARISOPRODOL

ABLE
COREPHARMA
HIKMA INTL PHARMS
PIONEER PHARMS
PROSAM LABS
SANDOZ
WATSON LABS

450MG/VIAL

50MG/VIAL

150MG/VIAL

450MG/VIAL

50MG/VIAL

150MG/VIAL

450MG/VIAL

50MG/VIAL

150MG/VIAL

450MG/VIAL

50MG/VIAL

150MG/VIAL

450MG/VIAL

A076473
A091510
A091510
A091510
A076602
A076602
A076602
A076959
A076959
A076959
A076162
A076162
A076162

003
001
002
003
001
002
003
001
002
003
001
002
003

50MG/VIAL

150MG/VIAL

450MG/VIAL

N019880 001 Mar 03, 1989

N019880 002 Mar 03, 1989

N019880 003 Mar 03, 1989

50MG/5ML (10MG/ML)

50MG/5ML (10MG/ML)

150MG/15ML (10MG/ML)

150MG/15ML (10MG/ML)

50MG/5ML (10MG/ML)

150MG/15ML (10MG/ML)

450MG/45ML (10MG/ML)

50MG/5ML (10MG/ML)

150MG/15ML (10MG/ML)

450MG/45ML (10MG/ML)

A077247
A077266
A077247
A077266
A077679
A077679
A077679
A077389
A077389
A077389

001
001
002
002
001
002
003
001
002
003

Oct
Feb
Oct
Feb
Feb
Feb
Feb
Mar
Mar
Mar

21,
15,
21,
15,
25,
25,
25,
30,
30,
30,

2004

2006

2004

2006

2009

2009

2009

2007

2007

2007

50MG/5ML (10MG/ML)

150MG/15ML (10MG/ML)

450MG/45ML (10MG/ML)

600MG/60ML (10MG/ML)

N020452
N020452
N020452
N020452

001
002
003
004

Jul
Jul
Jul
Jan

14,
14,
14,
15,

2003

2003

2003

2004

250MG

N011792 003

350MG

350MG

350MG

350MG

350MG

350MG

350MG

350MG

350MG

350MG

A040421
A040397
A040124
A089390
A040188
A081025
A089566
A040152
A085433
A086179

Jun
Sep
Jan
Oct
Mar
Apr
Aug
Dec

21,
21,
24,
13,
07,
13,
30,
03,

2001

2000

1996

1988

1997

1989

1988

1996

350MG

N012155 001

50MG/ML

N014173 001

12.5MG

25MG

50MG

N012768 001

N012768 002

N012768 004

100MG

150MG

N018550 002 Dec 31, 1987

N018550 003 Dec 31, 1987

001
001
001
001
001
001
001
001
001

001

Oct
May
May
May
Nov
Nov
Nov
Mar
Mar
Mar
Oct
Oct
Oct

27,
29,
29,
29,
16,
16,
16,
18,
18,
18,
14,
14,
14,

2004

2012

2012

2012

2004

2004

2004

2005

2005

2005

2004

2004

2004

RELA

SCHERING
CARPHENAZINE MALEATE

CONCENTRATE;ORAL

PROKETAZINE

WYETH AYERST
TABLET;ORAL

PROKETAZINE

WYETH AYERST

CARPROFEN

TABLET;ORAL

RIMADYL

ROCHE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-62(of 347)

DISCONTINUED DRUG PRODUCT LIST

CARTEOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CARTEOLOL HYDROCHLORIDE
APOTEX INC
TABLET;ORAL
CARTROL
ABBVIE

CARVEDILOL
TABLET;ORAL
CARVEDILOL
HIKMA

WOCKHARDT LTD

CEFACLOR
CAPSULE;ORAL
CECLOR
LILLY
CEFACLOR
CEPH INTL
DAVA PHARMS INC
IVAX SUB TEVA PHARMS
RANBAXY
TEVA

WATSON LABS INC

FOR SUSPENSION;ORAL
CECLOR
LILLY
CEFACLOR
DAVA PHARMS INC

FACTA FARMA

IVAX SUB TEVA PHARMS

RANBAXY

WATSON LABS INC

TABLET, CHEWABLE;ORAL
RANICLOR
RANBAXY LABS LTD

1%

A076097 001 Feb 06, 2002

2.5MG
5MG
10MG

N019204 001 Dec 28, 1988

N019204 002 Dec 28, 1988
N019204 003 Dec 28, 1988

3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG

A077887
A077887
A077887
A077887
A078786
A078786
A078786
A078786

EQ 250MG BASE
EQ 500MG BASE

N050521 001
N050521 002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A062205
A062205
A064107
A064107
A064061
A064061
A064156
A064156
A064081
A064145
A064081
A064145
A064148
A064148

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
003
004
001
002
003
004

001
002
001
002
001
002
001
002
001
001
002
002
001
002

Sep
Sep
Sep
Sep
Dec
Dec
Dec
Dec

07,
07,
07,
07,
22,
22,
22,
22,

2007
2007
2007
2007
2009
2009
2009
2009

Apr
Apr
Apr
Apr
Aug
Aug
Sep
Jun
Sep
Jun
May
May

27,
27,
27,
27,
28,
28,
16,
24,
16,
24,
23,
23,

1995
1995
1995
1995
1997
1997
1996
1996
1996
1996
1996
1996

28,
28,
28,
28,

1995
1995
1995
1995

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

N050522 001
N050522 002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

125MG
187MG
250MG
375MG
125MG
187MG
250MG
375MG
125MG
187MG
250MG
375MG
125MG
187MG
250MG
375MG
125MG
187MG
250MG
375MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A064114
A064115
A064116
A064110
A062206
A062206
A062206
A062206
A064087
A064086
A064085
A064070
A064166
A064165
A064164
A064155
A064204
A064205
A064206
A064207

001
001
001
001
001
003
002
004
001
001
001
001
001
001
001
001
001
001
001
001

Apr
Apr
Apr
Apr

Apr
Apr
Apr
Apr
Apr
Oct
Oct
Oct
Oct
Feb
Feb
Feb
Feb

20,
28,
28,
28,
28,
02,
02,
02,
02,
18,
18,
18,
18,

1988
1995
1995
1995
1995
1997
1997
1997
1997
1998
1998
1998
1998

EQ
EQ
EQ
EQ

125MG
187MG
250MG
375MG

BASE
BASE
BASE
BASE

A065092
A065092
A065092
A065092

001
002
003
004

Dec
Dec
Dec
Dec

22,
22,
22,
22,

2003
2003
2003
2003

Apr 20, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-63(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEFACLOR

TABLET, EXTENDED RELEASE;ORAL

CECLOR CD

LILLY
EQ 375MG BASE

EQ 500MG BASE

CEFACLOR

WORLD GEN
EQ 500MG BASE

CEFADROXIL/CEFADROXIL HEMIHYDRATE

CAPSULE;ORAL

CEFADROXIL

IVAX SUB TEVA PHARMS
EQ
PUREPAC PHARM
EQ
RANBAXY LABS LTD
EQ
TEVA
EQ
DURICEF

WARNER CHILCOTT
EQ
EQ
ULTRACEF

BRISTOL
EQ
FOR SUSPENSION;ORAL

CEFADROXIL

ANI PHARMS INC
EQ
EQ
EQ
EQ
EQ
APOTHECON
EQ
EQ
EQ
DURICEF

WARNER CHILCOTT
EQ
EQ
EQ
ULTRACEF

BRISTOL
EQ
EQ
EQ
TABLET;ORAL

CEFADROXIL

RANBAXY
EQ
DURICEF

WARNER CHILCOTT
EQ
ULTRACEF

APOTHECON
EQ
BRISTOL
EQ
CEFAMANDOLE NAFATE

INJECTABLE;INJECTION

MANDOL

LILLY

CEFAZOLIN SODIUM

INJECTABLE;INJECTION

ANCEF

GLAXOSMITHKLINE

EQ
EQ
EQ
EQ
EQ
EQ

500MG
500MG
500MG
500MG

BASE

BASE

BASE

BASE

N050673 001
Jun 28, 1996

N050673 002
Jun 28, 1996

A065057 001
Jan 05, 2001

A062766
A063017
A065015
A062695

001

001

001

001

Mar
Jan
Jun
Feb

03,
05,
22,
10,

1987

1989

1999

1989

250MG BASE

500MG BASE

N050512 002

N050512 001

500MG BASE

A062378 001
Mar 16, 1982

125MG
250MG
250MG
500MG
500MG
125MG
250MG
500MG

A062698
A062698
A065278
A062698
A065278
A062334
A062334
A062334

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

001

002

001

003

002

001

002

003

Mar
Mar
Jan
Mar
Jan

01,
01,
20,
01,
20,

1989

1989

2006

1989

2006

125MG BASE/5ML

250MG BASE/5ML

500MG BASE/5ML

N050527 002

N050527 003

N050527 001

125MG BASE/5ML

250MG BASE/5ML

500MG BASE/5ML

A062376 001
Mar 16, 1982

A062376 002
Mar 16, 1982

A062376 003
Mar 16, 1982

1GM BASE

A065018 001
Apr 23, 1999

1GM BASE

N050528 001

1GM BASE

1GM BASE

A062390 001
Jun 10, 1982

A062408 001
Aug 31, 1982

500MG BASE/VIAL

1GM BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

2GM BASE/VIAL

10GM BASE/VIAL

N050504
A062560
N050504
A062560
N050504
N050504

EQ 250MG BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 5GM BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 10GM BASE/VIAL

001

001
Sep 10, 1985

002

002
Sep 10, 1985

003

004

N050461 001

N050461 002

N050461 003

N050461 004

N050461 005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-64(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEFAZOLIN SODIUM

INJECTABLE;INJECTION

ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
EQ 10MG BASE/ML

EQ 20MG BASE/ML

ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARE
EQ 10MG BASE/ML

EQ 20MG BASE/ML

CEFAZOLIN AND DEXTROSE

B BRAUN
EQ 500MG BASE/VIAL

CEFAZOLIN SODIUM

ABRAXIS PHARM
EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 20GM BASE/VIAL

AUROBINDO PHARMA
EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

BEDFORD
EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

CEPHAZONE PHARMA
EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 20GM BASE/VIAL

FRESENIUS KABI USA

EQ 500MG BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 1GM BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 10GM BASE/VIAL

EQ 20GM BASE/VIAL

GLAXOSMITHKLINE
EQ 1GM BASE/VIAL

HIKMA MAPLE
EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 20GM BASE/VIAL

STERI PHARMA
EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

TEVA PHARMS
EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

WATSON LABS INC

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

EQ 20GM BASE/VIAL

KEFZOL

ACS DOBFAR
EQ 250MG BASE/VIAL

EQ 20GM BASE/VIAL

LILLY
EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

CEFDINIR

CAPSULE;ORAL

OMNICEF

ABBVIE
FOR SUSPENSION;ORAL

OMNICEF

ABBVIE

N050566 003
Jun 08, 1983

N050566 004
Jun 08, 1983

N050566 001
Jun 08, 1983

N050566 002
Jun 08, 1983

N050779 001
Jul 27, 2000

A062688
A062688
A062688
A062688
A065395
A065395
A062894
A062894
A062894
A062894
A062894
A065280
A065280
A065295
A065296
A064169

002

003

004

005

001

002

001

002

003

004

005

001

002

001

001

001

Nov
Nov
Nov
Aug
Aug
Aug
Jul
Jul
Jul
Jul
Jul
Mar
Mar
Mar
Mar
Aug

17,
17,
17,
03,
08,
08,
21,
21,
21,
21,
21,
18,
18,
18,
18,
14,

1986

1986

1986

1987

2008

2008

1988

1988

1988

1988

1988

2009

2009

2009

2009

1998

A064169 002
Aug 14, 1998

Mar
Mar
Oct
Jan
Jan
Jan
Jan
Jan
Jan
Dec
Dec
Mar
Mar
Mar
Mar
Mar
Dec
Dec
Dec
Dec
Dec
Dec

18,
18,
31,
12,
12,
12,
12,
12,
12,
27,
27,
14,
14,
14,
05,
05,
29,
29,
29,
29,
29,
29,

1998

1998

1993

1988

1988

1988

1988

1988

1988

1991

1991

1989

1989

1989

1990

1990

1989

1989

1989

1989

1989

1989

A064170
A064170
A064033
A062807
A062807
A062807
A062807
A062807
A062807
A063216
A063208
A063016
A063016
A063016
A063018
A063018
A062988
A062988
A062988
A062989
A062989
A062989

001

002

001

001

002

003

004

005

006

001

001

001

002

003

001

002

001

002

003

001

002

003

A061773
A061773
A062557
A062557

001

005
Sep 08, 1987

001
Sep 10, 1985

002
Sep 10, 1985

300MG

N050739 001
Dec 04, 1997

125MG/5ML

250MG/5ML

N050749 001
Dec 04, 1997

N050749 002
Jul 29, 2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-65(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEFEPIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFEPIME HYDROCHLORIDE
SANDOZ

CEFIXIME
FOR SUSPENSION;ORAL
SUPRAX
LEDERLE
TABLET;ORAL
SUPRAX
LEDERLE

CEFMENOXIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFMAX
TAP PHARM

EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL

A090291 001 Dec 21, 2010

A090291 002 Dec 21, 2010
A090291 003 Dec 21, 2010

100MG/5ML

N050622 001 Apr 28, 1989

200MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**
400MG

N050621 001 Apr 28, 1989

EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL

N050571 001 Dec 30, 1987

N050571 002 Dec 30, 1987
N050571 003 Dec 30, 1987

CEFMETAZOLE SODIUM
INJECTABLE;INJECTION
ZEFAZONE
PHARMACIA AND UPJOHN

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
ZEFAZONE IN PLASTIC CONTAINER
PHARMACIA AND UPJOHN
EQ 20MG BASE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 40MG BASE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

CEFONICID SODIUM
INJECTABLE;INJECTION
MONOCID
GLAXOSMITHKLINE

CEFOPERAZONE SODIUM
INJECTABLE;INJECTION
CEFOBID
PFIZER

EQ
EQ
EQ
EQ
EQ

EQ
EQ
EQ
EQ
EQ
CEFOBID IN PLASTIC CONTAINER
PFIZER
EQ
EQ

CEFORANIDE
INJECTABLE;INJECTION
PRECEF
APOTHECON

BRISTOL

N050621 002 Apr 28, 1989

N050637 001 Dec 11, 1989

N050637 002 Dec 11, 1989
N050683 001 Dec 29, 1992

N050683 002 Dec 29, 1992

500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

N050579
A063295
N050579
N050579
N050579

001
001
002
003
004

May
Jul
May
May
May

23,
26,
23,
23,
23,

1984
1993
1984
1984
1984

1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

A063333
N050551
A063333
N050551
N050551

001
001
002
002
003

Mar
Nov
Mar
Nov
Mar

31,
18,
31,
18,
05,

1995
1982
1995
1982
1990

20MG BASE/ML
40MG BASE/ML

N050613 002 Jul 31, 1987

N050613 001 Jul 23, 1986

500MG/VIAL
1GM/VIAL
2GM/VIAL
10GM/VIAL
20GM/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
10GM/VIAL
20GM/VIAL

A062579
A062579
A062579
A062579
A062579
N050554
N050554
N050554
N050554
N050554

001
002
003
004
005
001
002
003
004
005

Nov
Nov
Nov
Nov
Nov
May
May
May
May
May

26,
26,
26,
26,
26,
24,
24,
24,
24,
24,

1984
1984
1984
1984
1984
1984
1984
1984
1984
1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-66(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEFOTAXIME SODIUM
INJECTABLE;INJECTION
CEFOTAXIME
FRESENIUS KABI USA

EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
B BRAUN
EQ 2GM BASE
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
B BRAUN
EQ 1GM BASE
CEFOTAXIME SODIUM
AUROBINDO PHARMA
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
AUROBINDO PHARMA LTD
EQ 10GM BASE/VIAL
CEPHAZONE PHARMA
EQ 10GM BASE/VIAL
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
SANOFI AVENTIS US
EQ 20MG BASE/ML
EQ 40MG BASE/ML

CEFOTETAN DISODIUM
INJECTABLE;INJECTION
CEFOTAN
IGI LABS INC

EQ
EQ
EQ
EQ
EQ
CEFOTAN IN PLASTIC CONTAINER
IGI LABS INC
EQ
EQ

CEFOTIAM HYDROCHLORIDE
INJECTABLE;INJECTION
CERADON
TAKEDA
CEFOXITIN SODIUM
INJECTABLE;INJECTION
CEFOXITIN
FRESENIUS KABI USA

MEFOXIN IN
MERCK

CEFPODOXIME PROXETIL
FOR SUSPENSION;ORAL
BANAN
SANKYO
VANTIN
PHARMACIA AND UPJOHN

Mar
Mar
Mar
Mar
Mar

24,
24,
24,
24,
24,

2000
2000
2000
2000
2000

N050792 001 Jul 29, 2004

N050792 002 Jul 29, 2004
A065517
A065517
A065517
A065516
A065348

001
002
003
001
001

Nov
Nov
Nov
Nov
Jan

06,
06,
06,
06,
25,

2009
2009
2009
2009
2010

N050596 001 May 20, 1985

N050596 003 May 20, 1985

A063293
N050588
A063293
N050588
N050588

20MG BASE/ML
40MG BASE/ML

N050694 002 Jul 30, 1993

N050694 001 Jul 30, 1993

001
001
002
002
003

Apr
Dec
Apr
Dec
Apr

29,
27,
29,
27,
25,

1993
1985
1993
1985
1988

EQ 1GM BASE/VIAL

N050601 001 Dec 30, 1988

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL

A065012 001 Jul 03, 2000

A065012 002 Jul 03, 2000
A065011 001 Jul 03, 2000

EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
DEXTROSE 5% IN PLASTIC CONTAINER
EQ 20MG BASE/ML
EQ 40MG BASE/ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
EQ 20MG BASE/ML
EQ 40MG BASE/ML

CEFPIRAMIDE SODIUM
INJECTABLE;INJECTION
CEFPIRAMIDE SODIUM
WYETH AYERST

001
002
003
001
002

1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

MEFOXIN
MYLAN INSTITUTIONAL

MEFOXIN IN
MERCK

A064200
A064200
A064200
A064201
A064201

A062757
N050517
A062757
N050517
N050517

001 Jan 08, 1987

001
002 Jan 08, 1987
002
003

N050581 003 Sep 20, 1984

N050581 004 Sep 20, 1984
N050581 002 Sep 20, 1984
N050581 001 Sep 20, 1984

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL

N050633 002 Jan 31, 1989

N050633 003 Jan 31, 1989
N050633 005 Jan 31, 1989

EQ 50MG BASE/5ML
EQ 100MG BASE/5ML

N050688 002 Aug 07, 1992

N050688 001 Aug 07, 1992

EQ 50MG BASE/5ML
EQ 100MG BASE/5ML

N050675 001 Aug 07, 1992

N050675 002 Aug 07, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-67(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEFPODOXIME PROXETIL
TABLET;ORAL
BANAN
SANKYO
VANTIN
PHARMACIA AND UPJOHN
CEFPROZIL
FOR SUSPENSION;ORAL
CEFPROZIL
RANBAXY LABS LTD
CEFZIL
CORDEN PHARMA
TABLET;ORAL
CEFPROZIL
RANBAXY LABS LTD
CEFZIL
CORDEN PHARMA
CEFTAZIDIME
INJECTABLE;INJECTION
CEFTAZIDIME
AUROBINDO PHARMA LTD

CEPTAZ
GLAXOSMITHKLINE

PENTACEF
GLAXOSMITHKLINE

EQ 100MG BASE
EQ 200MG BASE

N050687 001 Aug 07, 1992

N050687 002 Aug 07, 1992

EQ 100MG BASE
EQ 200MG BASE

N050674 001 Aug 07, 1992

N050674 002 Aug 07, 1992

125MG/5ML
250MG/5ML

A065202 001 Jun 30, 2006

A065202 002 Jun 30, 2006

125MG/5ML
250MG/5ML

N050665 001 Dec 23, 1991

N050665 002 Dec 23, 1991

250MG
500MG

A065198 001 Dec 13, 2006

A065198 002 Dec 13, 2006

250MG
500MG

N050664 001 Dec 23, 1991

N050664 002 Dec 23, 1991

500MG/VIAL
1GM/VIAL
2GM/VIAL
6GM/VIAL

A065481
A065481
A065481
A065482

001
002
003
001

May
May
May
May

28,
28,
28,
28,

2010
2010
2010
2010

500MG/VIAL
1GM/VIAL
2GM/VIAL
10GM/VIAL

N050646
N050646
N050646
N050646

001
002
003
004

Sep
Sep
Sep
Sep

27,
27,
27,
27,

1990
1990
1990
1990

1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL
6GM/VIAL
10GM/VIAL

A063322
A064006
A063322
A064006
A064008
A064008

001
001
002
002
001
002

Nov
Mar
Nov
Mar
Mar
Mar

07,
31,
07,
31,
31,
31,

1995
1992
1995
1992
1992
1992

TAZIDIME
LILLY

1GM/VIAL
2GM/VIAL
TAZIDIME IN PLASTIC CONTAINER
LILLY
1GM/VIAL
2GM/VIAL
CEFTAZIDIME SODIUM
INJECTABLE;INJECTION
CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
BAXTER HLTHCARE
EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
FORTAZ IN PLASTIC CONTAINER
IGI LABS INC
EQ 10MG BASE/ML
CEFTIZOXIME SODIUM
INJECTABLE;INJECTION
CEFIZOX
ASTELLAS

EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER
ASTELLAS
EQ 20MG BASE/ML
EQ 40MG BASE/ML
CEFIZOX IN PLASTIC CONTAINER
ASTELLAS
EQ 20MG BASE/ML

A062655 001 Nov 20, 1985

A062655 002 Nov 20, 1985
A062739 001 Jul 10, 1986
A062739 002 Jul 10, 1986

A063221 001 Apr 29, 1993

A063221 002 Apr 29, 1993
A063221 003 Apr 29, 1993
N050634 001 Apr 28, 1989

N050560
A063294
N050560
A063294
N050560
N050560

001
002
002
003
003
005

Sep
Mar
Sep
Mar
Sep
Mar

15,
31,
15,
31,
15,
19,

1983
1994
1983
1994
1983
1993

N050589 001 Oct 03, 1984

N050589 002 Oct 03, 1984
N050589 003 Apr 13, 1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-68(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEFTIZOXIME SODIUM
INJECTABLE;INJECTION
CEFIZOX IN PLASTIC CONTAINER
EQ 40MG BASE/ML
CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
CEFTRIAXONE
AGILA SPECLTS
AUROBINDO PHARMA LTD
FRESENIUS KABI USA
TEVA
ROCEPHIN
HOFFMANN LA ROCHE

EQ
EQ
EQ
EQ

10GM
10GM
10GM
10GM

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
ROCHE
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
HOFFMANN LA ROCHE
EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONE
AUROBINDO PHARMA LTD
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
CEPHAZONE PHARMA
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
FACTA FARMA
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
FRESENIUS KABI USA
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
TEVA
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
TEVA PHARMS USA
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
ROCEPHIN
HOFFMANN LA ROCHE
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL

CEFTRIAXONE SODIUM; LIDOCAINE

INJECTABLE;INJECTION
ROCEPHIN KIT
HOFFMANN LA ROCHE
CEFUROXIME AXETIL
TABLET;ORAL
CEFUROXIME AXETIL
RANBAXY LABS LTD

SANDOZ

N050589 004 Apr 13, 1995

A091068
A065504
A065252
A065274

001
001
001
001

Jan
Jul
Feb
May

07,
31,
15,
01,

2013
2008
2006
2006

A063239
A062654
A062654
A062654
N050585
A062510
A062510
A062510

001
001
002
003
005
001
002
003

Aug
Apr
Apr
Apr
Dec
Mar
Mar
Mar

13,
30,
30,
30,
21,
12,
12,
12,

1993
1987
1987
1987
1984
1985
1985
1985

N050624 001 Feb 11, 1987

N050624 002 Feb 11, 1987
N050624 003 Feb 11, 1987

A065505
A065505
A065505
A065505
A065294
A065294
A065294
A065294
A065268
A065268
A065245
A065245
A065245
A065245
A065262
A065262
A065227
A065227
A065227
A065227

001
002
003
004
001
002
003
004
001
002
001
002
003
004
001
002
001
002
003
004

Jul
Jul
Jul
Jul
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Jun
Jun
Mar
Mar
Mar
Mar

31,
31,
31,
31,
26,
26,
26,
26,
28,
28,
15,
15,
15,
15,
29,
29,
15,
15,
15,
15,

2008
2008
2008
2008
2007
2007
2007
2007
2007
2007
2006
2006
2006
2006
2006
2006
2007
2007
2007
2007

N050585
N050585
N050585
N050585

001
002
003
004

Dec
Dec
Dec
Dec

21,
21,
21,
21,

1984
1984
1984
1984

EQ 500MG BASE/VIAL,N/A;N/A,1%
EQ 1GM BASE/VIAL,N/A;N/A,1%

N050585 007 May 08, 1996

N050585 006 May 08, 1996

EQ
EQ
EQ
EQ
EQ

A065043
A065043
A065043
A065126
A065126

125MG
250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE

003
002
001
001
002

Feb
Feb
Feb
Oct
Oct

15,
15,
15,
28,
28,

2002
2002
2002
2003
2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-69(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEFUROXIME SODIUM
INJECTABLE;INJECTION
CEFUROXIME SODIUM
FRESENIUS KABI USA

EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
TEVA PHARMS
EQ 7.5GM BASE/VIAL
WATSON LABS INC
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
CEFUROXIME SODIUM IN PLASTIC CONTAINER
SAMSON MEDCL
EQ 75GM BASE/VIAL
EQ 225GM BASE/VIAL
KEFUROX
ACS DOBFAR
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
LILLY
EQ 1.5GM BASE/VIAL
KEFUROX IN PLASTIC CONTAINER
LILLY
EQ 1.5GM BASE/VIAL
ZINACEF IN PLASTIC CONTAINER
CONCORDIA PHARMS INC
EQ 15MG BASE/ML
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUM
FRESENIUS KABI USA
EQ 750MG BASE/VIAL
TEVA PHARMS
EQ 750MG BASE/VIAL
EQ 1.5GM BASE/VIAL
WATSON LABS INC
EQ 750MG BASE/VIAL
KEFUROX
ACS DOBFAR
EQ 750MG BASE/VIAL
INJECTABLE;INTRAVENOUS
KEFUROX
LILLY
EQ 750MG BASE/VIAL
KEFUROX IN PLASTIC CONTAINER
LILLY
EQ 750MG BASE/VIAL

CELLULOSE SODIUM PHOSPHATE

POWDER;ORAL
CALCIBIND
MISSION PHARMA
CEPHALEXIN
CAPSULE;ORAL
CEPHALEXIN
APOTHECON

BARR
FACTA FARMA
IVAX SUB TEVA PHARMS
PUREPAC PHARM
STEVENS J
TEVA

YOSHITOMI
KEFLEX
SHIONOGI INC
FOR SUSPENSION;ORAL
CEPHALEXIN
APOTHECON
BARR
FACTA FARMA

A065001
A065002
A064191
A064035
A064036

002
001
001
002
001

May
Sep
Apr
Feb
Feb

30,
28,
16,
26,
26,

2001
1998
1998
1993
1993

A065251 001 Dec 30, 2009

A065251 002 Dec 30, 2009
A062591 002 Jan 10, 1986
A062591 003 Dec 17, 1987
A062592 002 Jan 10, 1986
A062590 002 Jan 10, 1986
N050643 001 Apr 28, 1989

A065001
A064192
A064192
A064035

001
002
001
001

May
Apr
Apr
Feb

30,
16,
16,
26,

2001
1998
1998
1993

A062591 001 Jan 10, 1986

A062592 001 Jan 10, 1986

A062590 001 Jan 10, 1986

2.5GM/PACKET
300GM/BOT

N018757 002 Dec 28, 1982

N018757 003 Oct 16, 1984

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A062973
A063063
A063186
A062974
A063063
A063186
A062773
A062775
A062118
A062118
A061969
A061969
A062809
A062809
A062870
A062869
A062760
A062821
A062761
A062823
A062872
A062871

250MG
250MG
250MG
500MG
500MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
002
002
001
001
001
002
001
002
001
002
001
001
001
001
001
001
001
001

Nov
Sep
Dec
Nov
Sep
Dec
Jun
Apr

08,
29,
30,
23,
29,
30,
26,
22,

1988
1989
1994
1988
1989
1994
1987
1987

Apr
Apr
Mar
Mar
Apr
Feb
Apr
Feb
Jun
Jul

22,
22,
17,
17,
24,
05,
24,
05,
20,
05,

1987
1987
1988
1988
1987
1988
1987
1988
1988
1988

EQ 333MG BASE

N050405 004 May 12, 2006

EQ
EQ
EQ
EQ
EQ

A062986
A062987
A062778
A062777
A062117

125MG
250MG
125MG
250MG
100MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/ML

001
001
001
001
001

Apr
Jul
Aug
Aug

18,
25,
06,
06,

1991
1989
1987
1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-70(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEPHALEXIN

FOR SUSPENSION;ORAL

CEPHALEXIN

HIKMA PHARMS
SUN PHARM INDS LTD
TEVA

VITARINE
YUNG SHIN PHARM
KEFLEX

SHIONOGI INC

TABLET;ORAL

CEPHALEXIN

BARR
VITARINE

KEFLET

LILLY

TABLET, FOR SUSPENSION;ORAL

PANIXINE DISPERDOSE

RANBAXY LABS LTD
CEPHALEXIN HYDROCHLORIDE

TABLET;ORAL

KEFTAB

LILLY

CEPHALOGLYCIN

CAPSULE;ORAL

KAFOCIN

LILLY
CEPHALOTHIN SODIUM

INJECTABLE;INJECTION

CEPHALOTHIN

INTL MEDICATION

CEPHALOTHIN SODIUM

ABBOTT

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

125MG
250MG
125MG
250MG
125MG
250MG
125MG
125MG
250MG
250MG
125MG
250MG
125MG
250MG

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

A062117
A062117
A065444
A065444
A065081
A065081
A062767
A062873
A062768
A062867
A062779
A062781
A065336
A065336

002

003

001
002
001
002
001
001
001
001
001
001
001
002

Aug
Aug
Jul
Jul
Jun
May
Jun
Apr
Dec
Dec
Jul
Jul

28,
28,
27,
27,
16,
23,
16,
15,
22,
22,
25,
25,

2009

2009

2001

2001

1987

1988

1987

1988

1987

1987

2007

2007

Aug
Aug
Aug
Aug
Aug

17,
17,
11,
11,
11,

1987

1987

1988

1988

1988

EQ 100MG BASE/ML

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

N050406 003

N050406 001

N050406 002

EQ
EQ
EQ
EQ
EQ

250MG BASE

500MG BASE

250MG BASE

500MG BASE

1GM BASE

A062826
A062827
A062863
A062863
A062863

001
001
001
002
003

EQ
EQ
EQ
EQ
EQ

250MG BASE

250MG BASE

500MG BASE

500MG BASE

1GM BASE

A062745
N050440
A062745
N050440
N050440

001 Dec 01, 1986

003 Feb 26, 1987

002 Dec 01, 1986

001

002

EQ 125MG BASE

EQ 250MG BASE

A065100 002 Sep 11, 2003

A065100 001 Sep 11, 2003

EQ 250MG BASE

EQ 333MG BASE

EQ 500MG BASE

N050614 001 Oct 29, 1987

N050614 003 May 16, 1988

N050614 002 Oct 29, 1987

250MG

N050219 001

EQ
EQ
EQ
EQ

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

A062426
A062426
A062426
A062426

001
002
003
004

May
May
May
May

03,
03,
03,
03,

1985

1985

1985

1985

1GM BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

2GM BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

IN PLASTIC CONTAINER

20MG BASE/ML

20MG BASE/ML

20MG BASE/ML

40MG BASE/ML

40MG BASE/ML

A062547
A062548
A062547
A062548
A062666
A062666
A062464
A062464
A062464

001
001
002
002
002
001
001
002
003

Sep
Sep
Sep
Sep
Jun
Jun
May
May
May

11,
11,
11,
11,
10,
10,
07,
07,
07,

1985

1985

1985

1985

1987

1987

1984

1984

1984

A062422
A062422
A062730
A062422
A062422

003
005
001
004
006

Jan
Jul
Mar
Jan
Jul

31,
16,
05,
31,
16,

1984

1991

1987

1984

1991

EQ
EQ
EQ
EQ
ABRAXIS PHARM
EQ
EQ
BRISTOL
EQ
EQ
EQ
CEPHALOTHIN SODIUM W/ DEXTROSE
BAXTER HLTHCARE
EQ
EQ
EQ
EQ
EQ

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-71(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEPHALOTHIN SODIUM
INJECTABLE;INJECTION
CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER
EQ 40MG BASE/ML
CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER
BAXTER HLTHCARE
EQ 20MG BASE/ML
EQ 40MG BASE/ML
KEFLIN
LILLY
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 20GM BASE/VIAL
KEFLIN IN PLASTIC CONTAINER
LILLY
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
SEFFIN
GLAXOSMITHKLINE
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
CEPHAPIRIN SODIUM
INJECTABLE;INJECTION
CEFADYL
APOTHECON

CEPHAPIRIN SODIUM
ABRAXIS PHARM

HIKMA MAPLE

CEPHRADINE
CAPSULE;ORAL
ANSPOR
GLAXOSMITHKLINE
CEPHRADINE
BARR
IVAX SUB TEVA PHARMS
TEVA
VITARINE
VELOSEF
APOTHECON
VELOSEF '250'
ERSANA
VELOSEF '500'
ERSANA
FOR SUSPENSION;ORAL
ANSPOR
GLAXOSMITHKLINE

A062730 002 Mar 05, 1987

A062422 001 Jan 31, 1984
A062422 002 Jan 31, 1984
N050482
N050482
N050482
N050482

001
002
003
007

A062549 001 Sep 10, 1985

A062549 002 Sep 10, 1985
A062435 001 Nov 15, 1983
A062435 002 Nov 15, 1983
A062435 003 Nov 15, 1983

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
4GM BASE/VIAL
4GM BASE/VIAL
20GM BASE/VIAL

A062961
N050446
A061769
A062724
A062961
N050446
A061769
A062724
A062961
N050446
A061769
A062961
N050446
N050446

001
005
001
001
002
001
002
002
003
002
003
004
003
004

Sep 20, 1988

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
20GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
20GM BASE/VIAL

A062723
A062723
A062723
A062723
A062723
A062720
A062720
A062720
A062720

001
002
003
004
005
001
002
003
004

Nov
Nov
Nov
Nov
Nov
Jul
Jul
Jul
Jul

17,
17,
17,
17,
17,
02,
02,
02,
02,

1986
1986
1986
1986
1986
1987
1987
1987
1987

Apr
Apr
Mar
Mar
Jan
Jan
Feb
Feb

22,
22,
06,
06,
09,
09,
25,
25,

1988
1988
1987
1987
1987
1987
1988
1988

250MG
500MG

A061859 001
A061859 002

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A062850
A062851
A062762
A062762
A062683
A062683
A062813
A062813

250MG
500MG

A061764 001
A061764 002

250MG

N050548 001

500MG

N050548 002

125MG/5ML
250MG/5ML

A061866 001
A061866 002

001
001
001
002
001
002
001
002

Dec 23, 1986

Sep 20, 1988

Dec 23, 1986

Sep 20, 1988

Sep 20, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-72(of 347)

DISCONTINUED DRUG PRODUCT LIST

CEPHRADINE
FOR SUSPENSION;ORAL
CEPHRADINE
BARR
TEVA
VELOSEF '125'
APOTHECON
VELOSEF '250'
APOTHECON
INJECTABLE;INJECTION
VELOSEF
APOTHECON

TABLET;ORAL
VELOSEF
BRISTOL MYERS SQUIBB
CERIVASTATIN SODIUM
TABLET;ORAL
BAYCOL
BAYER PHARMS

CERULETIDE DIETHYLAMINE
INJECTABLE;INJECTION
TYMTRAN
PHARMACIA AND UPJOHN

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML

A062858
A062859
A062693
A062693

125MG/5ML

A061763 001

250MG/5ML

A061763 002

250MG/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
4GM/VIAL

A061976
A061976
A061976
A061976
A061976

1GM

N050530 001

0.05MG
0.1MG
0.2MG
0.3MG
0.4MG
0.8MG

N020740
N020740
N020740
N020740
N020740
N020740

0.02MG/ML

N018296 001

CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL
CETIRIZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC
5MG/5ML
APOTEX INC
5MG/5ML
AUROBINDO PHARMA LTD
5MG/5ML
RANBAXY LABS LTD
5MG/5ML
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS MID ATLANTIC
5MG/5ML
APOTEX INC
5MG/5ML
RANBAXY LABS LTD
5MG/5ML
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ACTAVIS MID ATLANTIC
5MG/5ML
APOTEX INC
5MG/5ML
RANBAXY LABS LTD
5MG/5ML
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS ELIZABETH
5MG
10MG
TABLET, CHEWABLE;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
SUN PHARM INDS INC
5MG
10MG
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
SUN PHARM INDS INC
5MG
10MG
CHILDREN'S ZYRTEC ALLERGY
J AND J CONSUMER INC
5MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
10MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CHILDREN'S ZYRTEC HIVES RELIEF
J AND J CONSUMER INC
5MG **Federal Register determination
that product was not discontinued or

A078617
A078412
A090751
A077472

001
001
001
002

May
May
Jan
Jan

19,
19,
09,
09,

1988
1988
1987
1987

Jun
Jun
Jun
Jun
May
Jul

26,
26,
26,
26,
24,
24,

1997
1997
1997
1997
1999
2000

Feb
Jun
Dec
Jun

02,
18,
16,
18,

2010
2008
2009
2008

001
002
004
003
005

001
002
003
004
005
006

001
001
001
001

A090378 002 May 09, 2008

A090188 002 Apr 22, 2008
A090183 002 Apr 24, 2008
A090378 001 May 09, 2008
A090188 001 Apr 22, 2008
A090183 001 Apr 24, 2008

A078615 003 Dec 28, 2007

A078615 004 Dec 28, 2007

A077631 004 Jan 11, 2008

A077631 003 Jan 11, 2008
A077631 001 Jan 11, 2008
A077631 002 Jan 11, 2008
N021621 003 Nov 16, 2007

N021621 004 Nov 16, 2007

N021621 005 Nov 16, 2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-73(of 347)

DISCONTINUED DRUG PRODUCT LIST

CETIRIZINE HYDROCHLORIDE
TABLET, CHEWABLE;ORAL
CHILDREN'S ZYRTEC HIVES RELIEF
withdrawn for safety or efficacy
reasons**
10MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CETRORELIX
INJECTABLE;INJECTION
CETROTIDE
EMD SERONO INC

EQ 3MG BASE/ML

N021621 006 Nov 16, 2007

N021197 002 Aug 11, 2000

CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL

FOR SUSPENSION;INTRATRACHEAL
EXOSURF NEONATAL
GLAXOSMITHKLINE
12MG/VIAL;108MG/VIAL;8MG/VIAL

N020044 001 Aug 02, 1990

CHENODIOL
TABLET;ORAL
CHENIX
SIGMA TAU

250MG

N018513 002 Jul 28, 1983

CHLOPHEDIANOL HYDROCHLORIDE
SYRUP;ORAL
ULO
3M

25MG/5ML

N012126 001

100MG

A060058 001

50MG
100MG

A060591 001
A060591 003

1%

N050183 001

25MG/VIAL

N050143 001

250MG/ML

N050153 001

1%

A060133 001

1%

A062439 001 Apr 21, 1983

1%

N050156 001

1%

A061187 001

1%

A061648 001

0.5%
0.5%

A062042 001
A062628 001 Sep 25, 1985

0.5%

A062437 001 Apr 14, 1983

0.5%

N050091 001

0.5%

A061645 001

0.5%

A061220 001

0.5%

A062171 001 Mar 31, 1982

0.5%

N050205 001

CHLORAMPHENICOL
CAPSULE;ORAL
AMPHICOL
FERRANTE
CHLOROMYCETIN
PARKEDALE
CREAM;TOPICAL
CHLOROMYCETIN
PARKE DAVIS
FOR SOLUTION;OPHTHALMIC
CHLOROMYCETIN
PARKEDALE
INJECTABLE;INJECTION
CHLOROMYCETIN
PARKE DAVIS
OINTMENT;OPHTHALMIC
CHLORAMPHENICOL
ALTANA
CHLOROFAIR
PHARMAFAIR
CHLOROMYCETIN
PARKEDALE
CHLOROPTIC S.O.P.
ALLERGAN
ECONOCHLOR
ALCON
SOLUTION/DROPS;OPHTHALMIC
CHLORAMPHENICOL
AKORN
ALCON
CHLOROFAIR
PHARMAFAIR
CHLOROPTIC
ALLERGAN
ECONOCHLOR
ALCON
OPHTHOCHLOR
PARKEDALE
OPTOMYCIN
OPTOPICS
SOLUTION/DROPS;OTIC
CHLOROMYCETIN
PARKEDALE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-74(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORAMPHENICOL PALMITATE

SUSPENSION;ORAL

CHLOROMYCETIN PALMITATE

PARKE DAVIS

EQ 150MG BASE/5ML

EQ 150MG BASE/5ML

CHLORAMPHENICOL SODIUM SUCCINATE

INJECTABLE;INJECTION

CHLORAMPHENICOL

ELKINS SINN
EQ 1GM
CHLORAMPHENICOL SODIUM SUCCINATE

GRUPPO LEPETIT
EQ 1GM
CHLOROMYCETIN
PARKEDALE
EQ 1GM
MYCHEL-S
ANGUS
EQ 1GM

A062301 001

N050152 001

BASE/VIAL

A062406 001 Nov 09, 1982

BASE/VIAL

A062278 001

BASE/VIAL

N050155 001

BASE/VIAL

A060132 001

CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN

OINTMENT;TOPICAL

ELASE-CHLOROMYCETIN

PARKE DAVIS
10MG/GM;666 UNITS/GM;1 UNITS/GM

N050294 001

CHLORAMPHENICOL; HYDROCORTISONE ACETATE

FOR SUSPENSION;OPHTHALMIC

CHLOROMYCETIN HYDROCORTISONE

PARKEDALE
12.5MG/VIAL;25MG/VIAL

N050202 001

CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

OPHTHOCORT

PARKEDALE
10MG/GM;5MG/GM;10,000 UNITS/GM

N050201 002

CHLORAMPHENICOL; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

CHLOROMYXIN

PARKE DAVIS
1%;10,000 UNITS/GM

N050203 002

CHLORAMPHENICOL; PREDNISOLONE

OINTMENT;OPHTHALMIC

CHLOROPTIC-P S.O.P.

ALLERGAN

A061188 001

1%;0.5%

CHLORDIAZEPOXIDE

CAPSULE, EXTENDED RELEASE;ORAL

LIBRELEASE

VALEANT PHARM INTL
30MG

TABLET;ORAL

LIBRITABS

VALEANT PHARM INTL
5MG

10MG

25MG

CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL

A-POXIDE

ABBOTT
5MG

5MG

10MG

10MG

25MG

25MG

CHLORDIAZACHEL

RACHELLE
5MG

10MG

25MG

CHLORDIAZEPOXIDE HYDROCHLORIDE

ASCOT
5MG

10MG

25MG

FERRANTE
5MG

10MG

25MG

HALSEY
5MG

10MG

25MG

HIKMA PHARMS LLC
5MG

N017813 001 Sep 12, 1983

A085482 001

A085481 001

A085488 001

A085447
A085517
A085447
A085518
A085447
A085513

001

001

002

001

003

001

A085086 001

A084639 001

A085087 001

A087525
A087524
A087512
A085118
A085119
A085120
A085340
A085339
A084685
A085014

001 Jan 07, 1982

001 Jan 07, 1982

001 Jan 07, 1982

001

001

001

001

001

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-75(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL

CHLORDIAZEPOXIDE HYDROCHLORIDE

10MG

25MG

IMPAX LABS

5MG

10MG

25MG

IVAX SUB TEVA PHARMS
5MG

10MG

25MG

LEDERLE

5MG

5MG

10MG

10MG

25MG

25MG

MAST MM

10MG

MYLAN

5MG

10MG

25MG

PARKE DAVIS

5MG

10MG

25MG

PIONEER PHARMS

10MG

25MG

PUREPAC PHARM

5MG

10MG

25MG

ROXANE

5MG

10MG

25MG

SANDOZ

5MG

5MG

10MG

10MG

25MG

25MG

SUPERPHARM

5MG

10MG

25MG

TEVA

5MG

10MG

25MG

25MG

USL PHARMA

5MG

25MG

VANGARD

5MG

10MG

25MG

WATSON LABS

5MG

10MG

25MG

LIBRIUM

VALEANT PHARM INTL

5MG

10MG

25MG

LYGEN

ALRA

5MG

10MG

25MG

INJECTABLE;INJECTION

LIBRIUM

VALEANT PHARMS LLC

100MG/AMP

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED

TABLET;ORAL

MENRIUM 10-4

ROCHE
10MG;0.4MG

MENRIUM 5-2

ROCHE
5MG;0.2MG

A085000
A085294
A086213
A085113
A086212
A083741
A083742
A083570
A086892
A087234
A086876
A087037
A086893
A087231
A086217
A084886
A084601
A084887
A085163
A084598
A085164
A089533
A089558
A085155
A084939
A085144
A084706
A084700
A084705
A084678
A084919
A084041
A084920
A084679
A084823
A088987
A088986
A088988
A088705
A088706
A086494
A088707
A084644
A084645
A088129
A088010
A088130
A086383
A086294
A086382

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001
001
001

002

001

001

001

001

001

001

001

001

002

001

001
001
001
001
001
001

001
001

001

001
001
001
001

001

001

N012249 002

N012249 001

N012249 003

A085107 001

A085009 001

A085108 001

N012301 001

N014740 006

N014740 002

Jul 15, 1988

Jul 15, 1988

Apr
Apr
Apr
Jan
Jan

25,
25,
25,
18,
18,

1985

1985

1985

1985

1985

Jan 18, 1985

Mar 28, 1983

Mar 28, 1983

Mar 28, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-76(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED
TABLET;ORAL
MENRIUM 5-4
ROCHE
5MG;0.4MG
CHLORHEXIDINE GLUCONATE
SOLUTION;DENTAL
CHLORHEXIDINE GLUCONATE
APOTEX INC
SOLUTION;TOPICAL
EXIDINE
XTTRIUM
MICRODERM
J AND J
PREVACARE R
J AND J
STERI-STAT
MATRIX MEDCL
SPONGE;TOPICAL
CHLORHEXIDINE GLUCONATE
KENDALL IL
E-Z SCRUB
BECTON DICKINSON
HIBICLENS
MOLNLYCKE HLTH

MICRODERM
J AND J
CHLORMERODRIN HG-197
INJECTABLE;INJECTION
CHLORMERODRIN HG 197
BRACCO
CHLORMEZANONE
TABLET;ORAL
TRANCOPAL
SANOFI AVENTIS US
CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
NESACAINE-MPF
FRESENIUS KABI USA
CHLOROQUINE HYDROCHLORIDE
INJECTABLE;INJECTION
ARALEN HYDROCHLORIDE
SANOFI AVENTIS US
CHLOROQUINE PHOSPHATE
TABLET;ORAL
CHLOROQUINE PHOSPHATE
MD PHARM
PUREPAC PHARM
TEVA
WATSON LABS

0.12%

A075561 001 Nov 14, 2000

2.5%

N019421 001 Dec 17, 1985

4%

A072255 001 Apr 15, 1991

0.5%

A072292 001 Jan 28, 1992

4%

A070104 001 Jul 24, 1986

4%

N019490 001 Mar 27, 1987

4%

A073416 001 Mar 14, 2000

4% **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N018423 001

4%

A072295 001 Feb 28, 1991

0.6-1.4mCi/ML

N017269 001

100MG
200MG

N011467 003
N011467 005

2%
3%

N009435 003
N009435 004

EQ 40MG BASE/ML

N006002 002

EQ
EQ
EQ
EQ
EQ

A087228
A080886
A087504
A087979
A088030

150MG
150MG
150MG
150MG
300MG

BASE
BASE
BASE
BASE
BASE

CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

TABLET;ORAL
ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE
SANOFI AVENTIS US
EQ 300MG BASE;EQ 45MG BASE
CHLOROTHIAZIDE
TABLET;ORAL
CHLOROTHIAZIDE
ABC HOLDING
HIKMA INTL PHARMS
LEDERLE
SANDOZ
WATSON LABS

N014740 004

250MG
250MG
500MG
250MG
500MG
250MG
250MG

001
001
001 Jan 13, 1982
001 Dec 21, 1982
001 Dec 21, 1982

N014860 002

A085569
A086028
A087736
A086940
A086938
A085485
A085165

001
001 Jul 14, 1982
001 Jul 14, 1982
001
001
001
001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-77(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLOROTHIAZIDE

TABLET;ORAL

CHLOROTHIAZIDE

DIURIL

OAK PHARMS AKORN

250MG

250MG

500MG

500MG

A085173
A086795
A084026
A086796

250MG

500MG

N011145 004

N011145 002

CHLOROTHIAZIDE; METHYLDOPA

TABLET;ORAL

ALDOCLOR-150

MERCK

150MG;250MG

ALDOCLOR-250

MERCK

250MG;250MG

METHYLDOPA AND CHLOROTHIAZIDE

PAR PHARM
150MG;250MG

250MG;250MG

CHLOROTHIAZIDE; RESERPINE

TABLET;ORAL

CHLOROTHIAZIDE AND RESERPINE

HIKMA PHARMS LLC

250MG;0.125MG

500MG;0.125MG

CHLOROTHIAZIDE W/ RESERPINE

WATSON LABS

250MG;0.125MG

500MG;0.125MG

CHLOROTHIAZIDE-RESERPINE

MYLAN

250MG;0.125MG

500MG;0.125MG

DIUPRES-250

MERCK

250MG;0.125MG

DIUPRES-500

MERCK

500MG;0.125MG

CHLOROTRIANISENE

CAPSULE;ORAL

CHLOROTRIANISENE

BANNER PHARMACAPS

TACE

SANOFI AVENTIS US

001

001 Aug 15, 1983

001 Sep 01, 1982

001 Aug 15, 1983

N016016 001

N016016 002

A070783 001 Nov 06, 1987

A070654 001 Nov 06, 1987

A088557 001 Dec 22, 1983

A088365 001 Dec 22, 1983

A084853 001

A088151 001 Jun 09, 1983

A087744 001 May 06, 1982

A087745 001 May 06, 1982

N011635 003 Aug 26, 1987

N011635 006 Aug 26, 1987

12MG

A084652 001

12MG

25MG

72MG

N008102 004

N011444 001

N016235 001

CHLOROXINE

SHAMPOO;TOPICAL

CAPITROL

WESTWOOD SQUIBB

2%

N017594 001

CHLORPHENESIN CARBAMATE

TABLET;ORAL

MAOLATE

PHARMACIA AND UPJOHN

400MG

N014217 002

CHLORPHENIRAMINE MALEATE

CAPSULE, EXTENDED RELEASE;ORAL

CHLORPHENIRAMINE MALEATE

SANDOZ

12MG

TELDRIN

GLAXOSMITHKLINE

8MG

12MG

INJECTABLE;INJECTION

CHLOR-TRIMETON

SCHERING PLOUGH

10MG/ML

100MG/ML

CHLORPHENIRAMINE MALEATE

BEL MAR

10MG/ML

ELKINS SINN

10MG/ML

WATSON LABS

10MG/ML

10MG/ML

100MG/ML

PYRIDAMAL 100

BEL MAR

100MG/ML

A070797 001 Aug 12, 1988

N017369 001

N017369 002

N008826 001

N008794 001

A080821
A080797
A083593
A086096
A086095

001

001

001

001

001

A083733 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-78(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORPHENIRAMINE MALEATE

SYRUP;ORAL

CHLOR-TRIMETON

SCHERING

CHLORPHENIRAMINE MALEATE

PHARM ASSOC

TABLET;ORAL

ANTAGONATE

BAYER PHARMS

CHLOR-TRIMETON

SCHERING

CHLORPHENIRAMINE MALEATE

ANABOLIC

BELL PHARMA

ELKINS SINN

IMPAX LABS

IVAX SUB TEVA PHARMS

KV PHARM

LEDERLE

MUTUAL PHARM

NEWTRON PHARMS

PANRAY

PHARMAVITE

PHARMERAL

PIONEER PHARMS

PUREPAC PHARM

PVT FORM

ROXANE

SANDOZ

VITARINE

WATSON LABS

2MG/5ML

N006921 006

2MG/5ML

A087520 001 Feb 10, 1982

4MG

A083381 001

4MG

N006921 002

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

4MG

A083078
A083062
A080938
A080809
A080779
A087164
A086941
A080700
A086519
A083243
A085104
A083753
A088556
A086306
A080786
A080626
A080961
A085837
A080696
A080791
A085139
A083787

WEST WARD

KLOROMIN

HALSEY

4MG

PHENETRON

LANNETT

4MG

TABLET, EXTENDED RELEASE;ORAL

CHLOR-TRIMETON

BAYER HEALTHCARE LLC
8MG

EFIDAC 24 CHLORPHENIRAMINE MALEATE

ALZA
16MG

CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

COLD CAPSULE IV

GRAHAM DM
12MG;75MG

COLD CAPSULE V

GRAHAM DM
8MG;75MG

TABLET, EXTENDED RELEASE;ORAL

TRIAMINIC-12

NOVARTIS
12MG;75MG

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CODIMAL-L.A. 12

SCHWARZ PHARMA
12MG;120MG

ISOCLOR

FISONS
8MG;120MG

PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

CENT PHARMS
8MG;120MG

GRAHAM DM
8MG;120MG

12MG;120MG

KV PHARM
12MG;120MG

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

CODEPREX

UCB INC
EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML

PENNTUSS

FISONS
EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML

001

001

001

001

001

001

001

001

001

001

001

001

001 Jul 13, 1984

001

001

001

001

001

001

001

001

001

A083629 001

A080846 001

N007638 001

N019746 002 Nov 18, 1994

N018793 001 Apr 25, 1985

N018794 001 Apr 23, 1985

N018115 001

N018935 001 Apr 15, 1985

N018747 001 Mar 06, 1986

N019428
N018844
N018843
A071455

001
001
001
001

Aug
Mar
Mar
Mar

02,
20,
18,
01,

1988

1985

1985

1989

N021369 001 Jun 21, 2004

N018928 001 Aug 14, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-79(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORPHENTERMINE HYDROCHLORIDE
TABLET;ORAL
PRE-SATE
PARKE DAVIS
EQ 65MG BASE

N014696 001

CHLORPROMAZINE
SUPPOSITORY;RECTAL
THORAZINE
GLAXOSMITHKLINE

N009149 024

25MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**
100MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**

CHLORPROMAZINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
THORAZINE
GLAXOSMITHKLINE
30MG
75MG
150MG
200MG
300MG
CONCENTRATE;ORAL
CHLORPROMAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC
100MG/ML
PHARM ASSOC
30MG/ML
100MG/ML
WOCKHARDT
30MG/ML
100MG/ML
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
CYCLE PHARMS LTD
30MG/ML
100MG/ML
SONAZINE
SANDOZ
30MG/ML
100MG/ML
THORAZINE
GLAXOSMITHKLINE
30MG/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
100MG/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
INJECTABLE;INJECTION
CHLORPROMAZINE HYDROCHLORIDE
ABRAXIS PHARM
25MG/ML
MARSAM PHARMS LLC
25MG/ML
WATSON LABS
25MG/ML
25MG/ML
WYETH AYERST
25MG/ML
THORAZINE
GLAXOSMITHKLINE
25MG/ML
SYRUP;ORAL
CHLORPROMAZINE HYDROCHLORIDE
ALPHARMA US PHARMS
10MG/5ML
SONAZINE
SANDOZ
10MG/5ML
THORAZINE
GLAXOSMITHKLINE
10MG/5ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
ABBOTT
10MG
25MG
50MG
100MG
200MG
CYCLE PHARMS LTD
10MG
25MG

N009149 033

N011120
N011120
N011120
N011120
N011120

016
017
018
019
020

A086863
A040231
A040224
A087032
A087053

001
001 Dec 30, 1999
001 Jan 26, 1999
001 Jul 08, 1982
001

A088157 001 Apr 27, 1983

A088158 001 Apr 27, 1983
A080983 004
A080983 005
N009149 032

N009149 043

A084911
A089563
A080365
A085591
A080370

001
001 Apr 15, 1988
001
001
001

N009149 011

A086712 001
A083040 001
N009149 022

A084414
A084415
A084411
A084412
A084413
A085331
A085331

001
001
001
001
001
001
002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-80(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORPROMAZINE HYDROCHLORIDE

TABLET;ORAL

CHLORPROMAZINE HYDROCHLORIDE

50MG

100MG

200MG

IVAX SUB TEVA PHARMS
10MG

25MG

50MG

100MG

200MG

KV PHARM
10MG

25MG

50MG

100MG

200MG

LEDERLE
10MG

25MG

50MG

100MG

200MG

PUREPAC PHARM
10MG

25MG

50MG

100MG

200MG

PVT FORM
25MG

50MG

200MG

SANDOZ
10MG

25MG

50MG

100MG

200MG

VANGARD
10MG

25MG

50MG

WATSON LABS
10MG

25MG

50MG

100MG

200MG

WEST WARD
10MG

25MG

50MG

100MG

200MG

PROMAPAR

PARKE DAVIS
10MG

25MG

50MG

100MG

200MG

THORAZINE

GLAXOSMITHKLINE
10MG

25MG

50MG

100MG

200MG

CHLORPROPAMIDE

TABLET;ORAL

CHLORPROPAMIDE

ANI PHARMS INC

DAVA PHARMS INC

100MG

100MG

100MG

100MG

100MG

250MG

250MG

250MG

100MG

250MG

A085331
A085331
A085331
A083549
A083549
A083549
A083574
A083575
A085750
A085751
A085484
A085752
A085748
A084803
A084801
A084800
A084789
A084802
A080403
A080403
A080403
A080403
A080403
A080340
A080340
A080340
A080439
A080439
A080439
A080439
A080439
A088038
A087645
A087646
A085959
A085956
A085960
A085957
A085958
A087783
A087865
A087878
A087884
A087880

003

004

005

001

002

003

001

001

002
001

001

001

002
001

001

001

001

001

004

001

002

003

005

001

002

003

001

002

003

004

005

001
001

001

001

001

001

001

001

001
001
001
001
001

A086886
A084423
A086887
A086888
A086885

001

001

001

001

001

N009149
N009149
N009149
N009149
N009149

002

007

013

018

020

A088768
A088812
A088840
A088918
A089446
A088813
A088919
A089447
A089561
A089562

001
001
001
001
001
001
001
001
001
001

Jan 04, 1982

Jan 04, 1982

Aug 16, 1982

Sep
Sep
Sep
Sep
Sep

16,
16,
15,
15,
16,

1982

1982

1982

1982

1982

Oct
Oct
Oct
Oct
Nov
Oct
Oct
Nov
Sep
Sep

11,
19,
25,
16,
17,
19,
16,
17,
04,
04,

1984

1984

1984

1984

1986

1984

1984

1986

1987

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-81(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORPROPAMIDE

TABLET;ORAL

CHLORPROPAMIDE

HALSEY
PAR PHARM
SANDOZ

SUPERPHARM
TEVA PHARMS USA
USL PHARMA
WATSON LABS

WATSON LABS INC

GLUCAMIDE

TEVA PHARMS USA
CHLORPROTHIXENE

CONCENTRATE;ORAL

TARACTAN

ROCHE
INJECTABLE;INJECTION

TARACTAN

ROCHE
TABLET;ORAL

TARACTAN

ROCHE

100MG

250MG

100MG

250MG

100MG

250MG

250MG

100MG

250MG

250MG

100MG

250MG

100MG

100MG

250MG

250MG

100MG

250MG

A089321
A088662
A088175
A088176
A088725
A084669
A088726
A088694
A088695
A087353
A088708
A088709
A086865
A088608
A086866
A088568
A088852
A088826

250MG

A088641 001 Oct 11, 1984

100MG/5ML

N016149 002

12.5MG/ML

N012487 001

10MG

25MG

50MG

100MG

N012486
N012486
N012486
N012486

CHLORTETRACYCLINE HYDROCHLORIDE

OINTMENT;OPHTHALMIC

AUREOMYCIN

LEDERLE
1%

CHLORTHALIDONE

TABLET;ORAL

CHLORTHALIDONE

ABBOTT
ASCOT
BARR LABS INC
DAVA PHARMS INC
G AND W LABS INC
IVAX PHARMS

KV PHARM
MUTUAL PHARM

PIONEER PHARMS
PUREPAC PHARM
SANDOZ

SUPERPHARM

25MG

50MG

25MG

50MG

25MG

50MG

25MG

50MG

50MG

25MG

25MG

50MG

50MG

25MG

50MG

25MG

25MG

25MG

50MG

50MG

50MG

25MG

50MG

25MG

50MG

50MG

25MG

50MG

001
001
001
001
001
001

001
001
001
001

001
001
001
001
001

001
001
001

Jan
Jan
Feb
Feb
Aug

16,
09,
27,
27,
31,

1986

1986

1984

1984

1984

Aug 31, 1984

Sep 17, 1984

Sep 17, 1984

Aug
Aug
Sep
Apr

30,
30,
24,
12,

1984

1984

1984

1984

Apr 12, 1984

Sep 26, 1984

Sep 26, 1984

005

004

003

001

N050404 001

A087364
A087384
A087698
A087699
A088902
A088903
A087451
A087450
A088651
A087555
A088164
A087176
A087947
A087311
A087312
A087292
A089285
A089738
A087293
A089739
A089591
A088139
A088140
A087380
A087118
A087381
A087473
A087247

001

001

001
001
001
001
001

001

001
001

001
001

001
001

001

001

001
001
001

001
001
001
001
001

001

001

001
001

Oct
Oct
Sep
Sep

20,
20,
19,
19,

1982

1982

1985

1985

May 30, 1985

Jan 09, 1984

Feb 27, 1984

Jul 21, 1986

Sep 19, 1988

Sep
Jul
Jul
Aug

19,
21,
16,
11,

1988

1988

1986

1983

Feb 09, 1983

Feb 09, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-82(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORTHALIDONE
TABLET;ORAL
CHLORTHALIDONE
USL PHARMA
VANGARD
WARNER CHILCOTT
WATSON LABS

HYGROTON
SANOFI AVENTIS US
THALITONE
CITRON PHARMA LLC
MONARCH PHARMS

25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG

A089051
A089052
A088012
A088073
A087515
A087516
A087050
A087100
A087296
A087706
A087029
A087082
A087521
A087689

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jun
Jul
Mar
Jan
Feb

01,
01,
14,
25,
24,
09,

1987
1987
1982
1983
1983
1983

25MG
50MG

N012283 004
N012283 003

15MG
25MG
25MG

N019574 001 Dec 20, 1988

N019574 002 Feb 12, 1992
A088051 001 Nov 12, 1982

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

TABLET;ORAL
CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
PAR PHARM
15MG;0.1MG
15MG;0.2MG
15MG;0.3MG
COMBIPRES
BOEHRINGER INGELHEIM
15MG;0.1MG
15MG;0.2MG
15MG;0.3MG

N017503 001
N017503 002
N017503 003 Apr 10, 1984

CHLORTHALIDONE; METOPROLOL TARTRATE

CAPSULE;ORAL
LOPRESSIDONE
NOVARTIS
25MG;100MG
25MG;200MG

N019451 001 Dec 31, 1987

N019451 002 Dec 31, 1987

CHLORTHALIDONE; RESERPINE
TABLET;ORAL
DEMI-REGROTON
SANOFI AVENTIS US
REGROTON
SANOFI AVENTIS US
CHLORZOXAZONE
TABLET;ORAL
CHLORZOXAZONE
ACTAVIS ELIZABETH
MUTUAL PHARM
OHM LABS
PAR PHARM
PIONEER PHARMS
SANDOZ
WATSON LABS

PARAFLEX
ORTHO MCNEIL PHARM

PARAFON FORTE DSC

JANSSEN R AND D

A071179 001 Dec 16, 1987

A071178 001 Dec 16, 1987
A071142 001 Dec 16, 1987

25MG;0.125MG

N015103 002

50MG;0.25MG

N015103 001

250MG
500MG
500MG
250MG
500MG
250MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG
500MG

A088928
A040113
A089970
A081298
A081299
A087981
A089592
A089948
A089852
A089853
A086901
A086948
A040137
A081019
A081040

250MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N011300 003

500MG

N011529 002 Jun 15, 1987

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

May
Sep
Sep
Dec
Dec
Sep
Jan
Jan
May
May

08,
29,
27,
29,
29,
20,
06,
06,
04,
04,

1987
1995
1990
1993
1993
1983
1989
1989
1988
1988

Aug
Aug
Jul
Aug

09,
09,
29,
22,

1982
1996
1991
1989

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-83(of 347)

DISCONTINUED DRUG PRODUCT LIST

CHLORZOXAZONE
TABLET;ORAL
STRIFON FORTE DSC
FERNDALE LABS
CHOLESTYRAMINE
BAR, CHEWABLE;ORAL
CHOLYBAR
PARKE DAVIS
POWDER;ORAL
CHOLESTYRAMINE
ANI PHARMS INC
IVAX SUB TEVA PHARMS
TEVA
CHOLESTYRAMINE LIGHT
TEVA
TEVA PHARMS
LOCHOLEST
SANDOZ

500MG

A081008 001 Dec 23, 1988

EQ 4GM RESIN/BAR
EQ 4GM RESIN/BAR

A071621 001 May 26, 1988

A071739 001 May 26, 1988

EQ
EQ
EQ
EQ
EQ
EQ

4GM
4GM
4GM
4GM
4GM
4GM

RESIN/PACKET
RESIN/SCOOPFUL
RESIN/PACKET
RESIN/SCOOPFUL
RESIN/PACKET
RESIN/SCOOPFUL

A074554
A074554
A074771
A074771
A074347
A074347

001
002
001
002
001
002

Oct
Oct
Jul
Jul
May
May

02,
02,
09,
09,
28,
28,

1996
1996
1997
1997
1998
1998

EQ
EQ
EQ
EQ

4GM
4GM
4GM
4GM

RESIN/PACKET
RESIN/SCOOPFUL
RESIN/PACKET
RESIN/SCOOPFUL

A074348
A074348
A074555
A074555

001
002
001
002

May
May
Sep
Sep

28,
28,
30,
30,

1998
1998
1998
1998

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

A074561 001 Aug 15, 1996

A074561 002 Aug 15, 1996

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

A074562 001 Aug 15, 1996

A074562 002 Aug 15, 1996

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

N016640 001
N016640 003

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

N019669 001 Dec 05, 1988

N019669 003 Dec 05, 1988

EQ 800MG RESIN
EQ 1GM RESIN

A073403 002 Dec 27, 1999

A073403 001 Apr 28, 1994

CHORIOGONADOTROPIN ALFA
INJECTABLE;INJECTION
OVIDREL
EMD SERONO

0.25MG/VIAL

N021149 001 Sep 20, 2000

CHROMIC CHLORIDE
INJECTABLE;INJECTION
CHROMIC CHLORIDE
ABRAXIS PHARM

EQ 0.004MG CHROMIUM/ML

N019271 001 May 05, 1987

CHROMIC PHOSPHATE P-32

INJECTABLE;INJECTION
PHOSPHOCOL P32
MALLINKRODT NUCLEAR

5mCi/ML

N017084 001

4,000 UNITS/VIAL
10,000 UNITS/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N018663 002 Aug 21, 1984

N018663 001 Nov 10, 1982

12,500 UNITS/VIAL

N018625 001 Jan 18, 1984

750 UNITS/VIAL

N011837 001

300 UNITS/VIAL
150 UNITS/VIAL

N016938 001
N018121 001

750 UNITS/VIAL

N011903 001

LOCHOLEST LIGHT
SANDOZ
QUESTRAN
BRISTOL MYERS
QUESTRAN LIGHT
BRISTOL MYERS
TABLET;ORAL
QUESTRAN
APOTHECON

CHYMOPAPAIN
INJECTABLE;INJECTION
CHYMODIACTIN
CHART MEDCL

DISCASE
ABBOTT
CHYMOTRYPSIN
FOR SOLUTION;OPHTHALMIC
ALPHA CHYMAR
SOLA BARNES HIND
CATARASE
CIBA
NOVARTIS
ZOLYSE
ALCON

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-84(of 347)

DISCONTINUED DRUG PRODUCT LIST

CICLOPIROX
SOLUTION;TOPICAL
CICLOPIROX
MYLAN PHARMS INC
TEVA PHARMS
CIDOFOVIR
INJECTABLE;INJECTION
VISTIDE
GILEAD SCIENCES INC

CILASTATIN SODIUM; IMIPENEM

INJECTABLE;INJECTION
PRIMAXIN
MERCK
POWDER;INTRAMUSCULAR
PRIMAXIN
MERCK
CILOSTAZOL
TABLET;ORAL
CILOSTAZOL
ACTAVIS ELIZABETH
COREPHARMA
IVAX SUB TEVA PHARMS
MUTUAL PHARM
CIMETIDINE
SUSPENSION;ORAL
TAGAMET HB 200
GLAXOSMITHKLINE
TABLET;ORAL
CIMETIDINE
CYCLE PHARMS LTD

DAVA PHARMS INC

IVAX SUB TEVA PHARMS

LEK PHARMS

PERRIGO
PLIVA

SANDOZ

TEVA

8%
8%

A078567 001 Sep 18, 2007

A078079 001 Sep 18, 2007

EQ 75MG BASE/ML **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N020638 001 Jun 26, 1996

EQ 250MG BASE/VIAL;250MG/VIAL
EQ 500MG BASE/VIAL;500MG/VIAL

A062756 001 Jan 08, 1987

A062756 002 Jan 08, 1987

EQ 750MG BASE/VIAL;750MG/VIAL

N050630 002 Dec 14, 1990

100MG
50MG
100MG
100MG
50MG
100MG

A077028
A077150
A077022
A077020
A077208
A077208

200MG/20ML

N020951 001 Jul 09, 1999

300MG
400MG
800MG
300MG
400MG
800MG
200MG
200MG
300MG
300MG
400MG
400MG
800MG
800MG
100MG
200MG
200MG
300MG
400MG
800MG
100MG
200MG
300MG
400MG
200MG
200MG
300MG
300MG
400MG
400MG
800MG
800MG
200MG
300MG
400MG
800MG

A074361
A074361
A074371
A074340
A074340
A074339
A074401
A074424
A074401
A074424
A074401
A074424
A074402
A074424
A075122
A074250
A075122
A074250
A074250
A074250
A074972
A074568
A074568
A074568
A074100
A074506
A074100
A074506
A074100
A074506
A074100
A074506
A074365
A074365
A074365
A074365

002
001
001
002
002
001

001
002
001
001
002
001
001
001
002
002
003
003
001
004
001
001
002
002
003
004
001
001
002
003
001
001
002
002
003
003
004
004
001
002
003
004

Nov
Mar
Nov
Mar
Mar
Mar

Dec
Dec
Dec
Jun
Jun
Jun
May
Jul
May
Jul
May
Jul
May
Jul
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Feb
Feb
Feb
Feb

26,
11,
23,
01,
29,
29,

23,
23,
23,
23,
23,
23,
30,
28,
30,
28,
30,
28,
30,
28,
19,
29,
19,
29,
29,
29,
19,
27,
27,
27,
31,
24,
31,
24,
31,
24,
31,
24,
28,
28,
28,
28,

2004
2005
2004
2005
2006
2006

1994
1994
1994
1995
1995
1995
1995
1995
1995
1995
1995
1995
1995
1995
1998
1995
1998
1995
1995
1995
1998
1997
1997
1997
1995
1996
1995
1996
1995
1996
1995
1996
1995
1995
1995
1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-85(of 347)

DISCONTINUED DRUG PRODUCT LIST

CIMETIDINE

TABLET;ORAL

CIMETIDINE

VINTAGE PHARMS LLC

WATSON LABS
WATSON LABS INC

TAGAMET

GLAXOSMITHKLINE

TAGAMET HB

MEDTECH PRODUCTS

200MG
300MG
400MG
800MG
200MG
200MG
300MG
400MG
800MG

A074281
A074281
A074281
A074329
A075425
A074349
A074349
A074349
A074316

200MG **Federal Registration

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

300MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

400MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

800MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N017920 002

100MG

N020238 001 Jun 19, 1995

CIMETIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

CIMETIDINE HYDROCHLORIDE

HOSPIRA

CINOXACIN

TEVA

May
May
May
May
Jul
Aug
Aug
Aug
Feb

17,
17,
17,
17,
29,
30,
30,
30,
28,

1994

1994

1994

1994

1999

1996

1996

1996

1996

N017920 003

N017920 004 Dec 14, 1983

N017920 005 Apr 30, 1986

EQ 300MG BASE/2ML
A074296
EQ 300MG BASE/2ML
A074344
EQ 300MG BASE/2ML
A074345
EQ 300MG BASE/2ML
A074412
EQ 300MG BASE/2ML
A074422
LUITPOLD
EQ 300MG BASE/2ML
A074353
TEVA PARENTERAL
EQ 300MG BASE/2ML
A074252
VINTAGE PHARMS LLC
EQ 300MG BASE/2ML
A074005
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

HOSPIRA
EQ 6MG BASE/ML
A074269
EQ 90MG BASE/100ML
A074468
EQ 120MG BASE/100ML
A074468
EQ 180MG BASE/100ML
A074468
EQ 240MG BASE/100ML
A074468
EQ 360MG BASE/100ML
A074468
EQ 480MG BASE/100ML
A074468
TAGAMET

GLAXOSMITHKLINE
EQ 300MG BASE/2ML
N017939
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

GLAXOSMITHKLINE
EQ 6MG BASE/ML
N019434
SOLUTION;ORAL

CIMETIDINE HYDROCHLORIDE

ANI PHARMS INC
EQ 300MG BASE/5ML
A074859
EQ 300MG BASE/5ML
A075110
APOTEX INC
EQ 300MG BASE/5ML
A075560
CYCLE PHARMS LTD
EQ 300MG BASE/5ML
A074541
G AND W LABS INC
EQ 300MG BASE/5ML
A074176
VINTAGE PHARMS LLC
EQ 300MG BASE/5ML
A074251
TAGAMET

GLAXOSMITHKLINE
EQ 300MG BASE/5ML
N017924

CINOXACIN

CAPSULE;ORAL

CINOBAC

LILLY

001
002
003
001
001
001
002
003
001

001
001
001
001
001
001
001
001

Mar
Jan
Jan
Mar
Jan
Dec
Nov
Aug

28,
31,
31,
28,
31,
20,
26,
31,

1997

1995

1995

1997

1995

1994

1997

1994

001
005
006
003
004
001
002

Dec
Dec
Dec
Dec
Dec
Dec
Dec

27,
29,
29,
29,
29,
29,
29,

1994

1994

1994

1994

1994

1994

1994

002

001 Oct 31, 1985

001
001
001
001
001
001

Jul
Jun
Mar
Aug
Jun
Dec

09,
18,
15,
05,
01,
22,

1998

1998

2000

1997

1994

1994

001

250MG
500MG

N018067 001

N018067 002

250MG
500MG

A073005 001 Feb 28, 1992

A073006 001 Feb 28, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-86(of 347)

DISCONTINUED DRUG PRODUCT LIST

CIPROFLOXACIN
INJECTABLE;INJECTION
CIPRO
BAYER HLTHCARE
1200MG/120ML (10MG/ML)
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAYER PHARMS
200MG/100ML
CIPROFLOXACIN
BEDFORD LABS
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
1200MG/120ML (10MG/ML)
FRESENIUS KABI USA
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
TEVA PHARMS USA
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
CIPROFLOXACIN IN DEXTROSE 5%
HIKMA FARMACEUTICA
200MG/100ML
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
200MG/100ML
400MG/200ML
BEDFORD
200MG/100ML
400MG/200ML
TEVA PHARMS
200MG/100ML
400MG/200ML
CIPROFLOXACIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CIPROFLOXACIN HYDROCHLORIDE
APOTEX INC
EQ 0.3% BASE
TABLET;ORAL
CIPROFLOXACIN HYDROCHLORIDE
BARR
EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
NOSTRUM LABS
EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
PLIVA
EQ 100MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
SANDOZ
EQ 100MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 750MG BASE
EQ 750MG BASE
TEVA
EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
TABLET, EXTENDED RELEASE;ORAL
PROQUIN XR
DEPOMED INC
EQ 500MG BASE
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CIPRO XR
BAYER HLTHCARE
212.6MG;EQ
425.2MG;EQ
CIPROFLOXACIN EXTENDED RELEASE
DR REDDYS LABS LTD
212.6MG;EQ
SANDOZ
212.6MG;EQ
CISAPRIDE MONOHYDRATE
SUSPENSION;ORAL
PROPULSID
JANSSEN PHARMS
TABLET;ORAL
PROPULSID
JANSSEN PHARMS

N019847 003 Dec 26, 1990

N019858 001 Dec 26, 1990
A076992
A076992
A076993
A076484
A076484
A077782
A077782

001
002
001
001
002
001
002

Aug
Aug
Aug
Aug
Aug
Aug
Aug

28,
28,
28,
28,
28,
28,
28,

2006
2006
2006
2006
2006
2006
2006

A076757 001 Apr 21, 2008

A077888
A077888
A078114
A078114
A077138
A077138

001
002
001
002
001
002

Mar
Mar
Mar
Mar
Mar
Mar

18,
18,
18,
18,
18,
18,

2008
2008
2008
2008
2008
2008

A075928 001 Jun 09, 2004

A074124
A074124
A074124
A076138
A076138
A076138
A076426
A076426
A076426
A076426
A075939
A075939
A076593
A075939
A076593
A075939
A076593
A076136
A076136
A076136

001
002
003
001
002
003
001
002
003
004
001
002
002
003
003
004
004
001
002
003

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

09,
09,
09,
09,
09,
09,
15,
15,
15,
15,
03,
09,
09,
09,
09,
09,
09,
09,
09,
09,

2004
2004
2004
2004
2004
2004
2005
2005
2005
2005
2005
2004
2004
2004
2004
2004
2004
2004
2004
2004

N021744 001 May 19, 2005

287.5MG BASE
574.9MG BASE

N021473 001 Dec 13, 2002

N021473 002 Aug 28, 2003

287.5MG BASE
287.5MG BASE

A077701 002 Oct 31, 2007

A078712 001 Dec 11, 2007

EQ 1MG BASE/ML

N020398 001 Sep 15, 1995

EQ 10MG BASE
EQ 20MG BASE

N020210 001 Jul 29, 1993

N020210 002 Dec 23, 1993

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-87(of 347)

DISCONTINUED DRUG PRODUCT LIST

CISAPRIDE MONOHYDRATE
TABLET, ORALLY DISINTEGRATING;ORAL
PROPULSID QUICKSOLV
JANSSEN PHARMA
EQ 20MG BASE
CISPLATIN
INJECTABLE;INJECTION
CISPLATIN
BEDFORD
TEVA PHARMS USA
PLATINOL
HQ SPCLT PHARMA
PLATINOL-AQ
HQ SPCLT PHARMA
CITALOPRAM HYDROBROMIDE
SOLUTION;ORAL
CELEXA
FOREST LABS

CITALOPRAM HYDROBROMIDE
APOTEX INC
TABLET;ORAL
CELEXA
FOREST LABS
CITALOPRAM HYDROBROMIDE
ACTAVIS ELIZABETH

N020767 001 Nov 07, 1997

10MG/VIAL
50MG/VIAL
1MG/ML

A074713 001 Nov 14, 2000

A074713 002 Nov 14, 2000
A074814 001 May 16, 2000

10MG/VIAL
50MG/VIAL

N018057 001
N018057 002

0.5MG/ML

N018057 003 Jul 18, 1984

EQ 10MG BASE/5ML **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N021046 001 Dec 22, 1999

EQ 10MG BASE/5ML

A077601 001 Nov 15, 2005

EQ 60MG BASE

N020822 004 Jul 17, 1998

EQ 10MG
EQ 20MG
EQ 40MG
COREPHARMA
EQ 10MG
EQ 20MG
EQ 40MG
MUTUAL PHARM
EQ 10MG
EQ 20MG
EQ 40MG
NATCO PHARMA LTD
EQ 20MG
EQ 40MG
ROXANE
EQ 10MG
EQ 20MG
EQ 40MG
SANDOZ
EQ 10MG
EQ 10MG
EQ 20MG
EQ 20MG
EQ 40MG
EQ 40MG
TARO
EQ 10MG
EQ 20MG
EQ 40MG
TEVA PHARMS
EQ 10MG
EQ 20MG
EQ 40MG
WATSON LABS
EQ 10MG
EQ 20MG
EQ 40MG
TABLET, ORALLY DISINTEGRATING;ORAL
CITALOPRAM HYDROBROMIDE
BIOVAIL LABS INTL
EQ 10MG
EQ 20MG
EQ 40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A077033
A077033
A077033
A077036
A077036
A077036
A077052
A077052
A077052
A077141
A077141
A077041
A077041
A077041
A077035
A077040
A077035
A077040
A077035
A077040
A077278
A077278
A077278
A077213
A077213
A077213
A077034
A077034
A077034

BASE
BASE
BASE

N021763 001 Dec 20, 2005

N021763 002 Dec 20, 2005
N021763 003 Dec 20, 2005

CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE

SOLUTION;IRRIGATION
IRRIGATING SOLUTION G IN PLASTIC CONTAINER
BAXTER HLTHCARE
3.24GM/100ML;380MG/100ML;430MG/100ML
UROLOGIC G IN PLASTIC CONTAINER
HOSPIRA
3.24GM/100ML;380MG/100ML;430MG/100ML

001
002
003
001
002
003
001
002
003
002
001
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003

Oct
Oct
Oct
Oct
Oct
Oct
Jul
Jul
Jul
Apr
Apr
Nov
Nov
Nov
Oct
Aug
Oct
Aug
Oct
Aug
Mar
Mar
Mar
Mar
Mar
Mar
Jun
Jun
Jun

28,
28,
28,
28,
28,
28,
03,
03,
03,
10,
10,
23,
23,
23,
28,
17,
28,
17,
28,
17,
22,
22,
22,
31,
31,
31,
30,
30,
30,

2004
2004
2004
2004
2004
2004
2006
2006
2006
2008
2008
2004
2004
2004
2004
2005
2004
2005
2004
2005
2006
2006
2006
2006
2006
2006
2005
2005
2005

N018519 001 Jun 22, 1982

N018904 001 May 27, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-88(of 347)

DISCONTINUED DRUG PRODUCT LIST

CLADRIBINE
INJECTABLE;INJECTION
LEUSTATIN
JANSSEN PHARMS

CLARITHROMYCIN
FOR SUSPENSION;ORAL
BIAXIN
ABBVIE
TABLET;ORAL
CLARITHROMYCIN
IVAX SUB TEVA PHARMS

1MG/ML **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N020229 001 Feb 26, 1993

187MG/5ML

N050698 003 Sep 30, 1998

250MG
500MG

A065137 001 May 31, 2005

A065137 002 May 31, 2005

TABLET, EXTENDED RELEASE;ORAL

BIAXIN XL
ABBVIE
500MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CLARITHROMYCIN
RANBAXY
1GM
SANDOZ
500MG
CLAVULANATE POTASSIUM; TICARCILLIN
INJECTABLE;INJECTION
TIMENTIN
GLAXOSMITHKLINE
EQ
EQ
EQ
EQ
TIMENTIN IN PLASTIC CONTAINER
GLAXOSMITHKLINE
EQ
CLEMASTINE FUMARATE
SYRUP;ORAL
CLEMASTINE FUMARATE
ACTAVIS MID ATLANTIC
APOTEX INC
SILARX
TEVA PHARMS
TAVIST
NOVARTIS
TABLET;ORAL
CLEMASTINE FUMARATE
ANI PHARMS INC
TAVIST
NOVARTIS
TAVIST-1
NOVARTIS
CLIDINIUM BROMIDE
CAPSULE;ORAL
QUARZAN
ROCHE
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLEOCIN
PHARMACIA AND UPJOHN
CLINDAMYCIN HYDROCHLORIDE
TEVA
WATSON LABS

EQ
EQ
EQ
EQ

N050775 001 Mar 03, 2000

A065210 001 Jan 26, 2005

A065250 001 Aug 25, 2005

DISODIUM

100MG BASE/VIAL;EQ 3GM BASE/VIAL

100MG BASE/VIAL;EQ 3GM BASE/VIAL
200MG BASE/VIAL;EQ 3GM BASE/VIAL
1GM BASE/VIAL;EQ 30GM BASE/VIAL

A062691
N050590
N050590
N050590

100MG BASE/100ML;EQ 3GM BASE/100ML

N050658 001 Dec 15, 1989

0.5MG
0.5MG
0.5MG
0.5MG

A074075
A075703
A074884
A073095

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

001
001
002
003

001
001
001
001

Dec
Apr
Apr
Aug

Oct
Nov
Dec
Apr

19,
01,
01,
18,

31,
27,
17,
21,

1986
1985
1985
1987

1993
2000
1997
1992

EQ 0.5MG BASE/5ML

N018675 001 Jun 28, 1985

1.34MG
1.34MG

A073282 001 Jan 31, 1992

A073282 002 Dec 03, 1992

2.68MG

N017661 001

1.34MG
1.34MG

N017661 002
N017661 003 Aug 21, 1992

2.5MG
5MG

N010355 001
N010355 002

EQ 75MG BASE
EQ 150MG BASE

A061809 001
A061809 002

EQ 75MG BASE
EQ 75MG BASE

A063027 001 Sep 20, 1989

A063082 001 Jul 31, 1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-89(of 347)

DISCONTINUED DRUG PRODUCT LIST

CLINDAMYCIN PALMITATE HYDROCHLORIDE
FOR SOLUTION;ORAL
CLEOCIN
PHARMACIA AND UPJOHN
EQ 75MG BASE/5ML
CLINDAMYCIN PHOSPHATE
CREAM;VAGINAL
CLEOCIN
PHARMACIA AND UPJOHN
INJECTABLE;INJECTION
CLEOCIN PHOSPHATE
PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE
ABRAXIS PHARM
BEDFORD
BRISTOL MYERS SQUIBB
HIKMA MAPLE

A061827 001

EQ 2% BASE

N050680 001 Aug 11, 1992

EQ 150MG BASE/ML

A061839 001

EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
IGI LABS INC
EQ 150MG BASE/ML
LOCH
EQ 150MG BASE/ML
MARSAM PHARMS LLC
EQ 150MG BASE/ML
SOLOPAK
EQ 150MG BASE/ML
EQ 150MG BASE/ML
TEVA PARENTERAL
EQ 150MG BASE/ML
EQ 150MG BASE/ML
WATSON LABS
EQ 150MG BASE/ML
EQ 150MG BASE/ML
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
ABRAXIS PHARM
EQ 12MG BASE/ML
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBVIE
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 18MG BASE/ML
BAXTER HLTHCARE
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 900MG BASE/100ML
SOLUTION;TOPICAL
CLEOCIN T
PHARMACIA AND UPJOHN
EQ 1% BASE
CLINDAMYCIN PHOSPHATE
BOCA PHARMA LLC
EQ 1% BASE
RENAISSANCE PHARMA
EQ 1% BASE
VINTAGE PHARMS
EQ 1% BASE

A062747
A063163
A062908
A062806
A062953
A063068
A062928
A062905
A062913
A062819
A062852
A063041
A063282
A062900
A063079

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jun
Feb
Oct
Apr
Aug
Feb
May
Oct
Mar
Mar
Dec
May
Jun
Mar

03,
30,
01,
15,
21,
28,
13,
09,
20,
15,
17,
29,
29,
08,
05,

1988
1994
1989
1987
1988
1989
1989
1988
1988
1988
1988
1989
1992
1988
1990

N050636 001 Dec 22, 1989

A065027
A065027
A065027
N050648
N050648
N050648

001
002
003
001
002
003

Jun
Jun
Jun
Dec
Dec
Dec

29,
29,
29,
29,
29,
29,

2001
2001
2001
1989
1989
1989

A062363 001 Feb 08, 1982

A062944 001 Jan 11, 1989
A064108 001 Sep 27, 1996
A062930 001 Jun 28, 1989

CLIOQUINOL; NYSTATIN
OINTMENT;TOPICAL
NYSTAFORM
BAYER PHARMS

10MG/GM;100,000 UNITS/GM

N050235 001

CLOBAZAM
TABLET;ORAL
ONFI
LUNDBECK LLC

5MG

N202067 001 Oct 21, 2011

CLOBETASOL PROPIONATE
CREAM;TOPICAL
CLOBETASOL PROPIONATE
RENAISSANCE PHARMA
0.05%
TEVA PHARMS USA
0.05%
CLOBETASOL PROPIONATE (EMOLLIENT)
RENAISSANCE PHARMA
0.05%
TEMOVATE
FOUGERA PHARMS
0.05% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TEMOVATE E
FOUGERA PHARMS
0.05% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
GEL;TOPICAL
TEMOVATE
FOUGERA PHARMS
0.05% **Federal Register determination

A075338 001 Feb 09, 2001

A074087 001 Feb 16, 1994
A075733 001 Aug 22, 2001
N019322 001 Dec 27, 1985

N020340 001 Jun 17, 1994

N020337 001 Apr 29, 1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-90(of 347)

DISCONTINUED DRUG PRODUCT LIST

CLOBETASOL PROPIONATE
GEL;TOPICAL
TEMOVATE
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
OINTMENT;TOPICAL
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTIC
RENAISSANCE PHARMA
SOLUTION;TOPICAL
TEMOVATE
FOUGERA PHARMS

CLOFAZIMINE
CAPSULE;ORAL
LAMPRENE
NOVARTIS
CLOFIBRATE
CAPSULE;ORAL
ATROMID-S
WYETH AYERST
CLOFIBRATE
BANNER PHARMACAPS
SANDOZ
TEVA
USL PHARMA
WATSON LABS
CLOMIPHENE CITRATE
TABLET;ORAL
MILOPHENE
MILEX
SEROPHENE
EMD SERONO
CLOMIPRAMINE HYDROCHLORIDE
CAPSULE;ORAL
CLOMIPRAMINE HYDROCHLORIDE
SANDOZ

TEVA

WATSON LABS

CLONAZEPAM
TABLET;ORAL
CLONAZEPAM
APOTEX INC

SANDOZ

TEVA

KLONOPIN
ROCHE

0.05%
0.05%

A074128 001 Aug 03, 1994

A075057 001 Aug 12, 1998

0.05% **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N019966 001 Feb 22, 1990

100MG

N019500 001 Dec 15, 1986

500MG

N016099 002

500MG
500MG
500MG
500MG
500MG

A073396
A072191
A072600
A070531
A071603

50MG

A072196 001 Dec 20, 1988

50MG

N018361 001 Mar 22, 1982

25MG
50MG
75MG
25MG
50MG
75MG
25MG
25MG
50MG
50MG
75MG
75MG

A074953
A074953
A074953
A074849
A074849
A074849
A074600
A074751
A074600
A074751
A074600
A074751

001
002
003
001
002
003
001
001
002
002
003
003

Jun
Jun
Jun
Apr
Apr
Apr
Nov
Sep
Nov
Sep
Nov
Sep

25,
25,
25,
04,
04,
04,
27,
30,
27,
30,
27,
30,

1997
1997
1997
1997
1997
1997
1996
1998
1996
1998
1996
1998

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG

A075468
A075468
A075468
A074925
A074925
A074925
A074920
A074920
A074920

001
002
003
001
002
003
001
002
003

Oct
Oct
Oct
Sep
Sep
Sep
Aug
Aug
Aug

06,
06,
06,
30,
30,
30,
04,
04,
04,

2000
2000
2000
1997
1997
1997
1998
1998
1998

0.125MG
0.25MG
TABLET, ORALLY DISINTEGRATING;ORAL
KLONOPIN RAPIDLY DISINTEGRATING

ROCHE
0.125MG **Federal Register
determination that product was not

discontinued or withdrawn for safety or

001
001
001
001
001

Mar
May
Jul
Jun
Sep

20,
02,
25,
16,
18,

1992
1988
1991
1986
1987

N017533 005 Apr 09, 1997

N017533 006 Apr 09, 1997

N020813 001 Dec 23, 1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-91(of 347)

DISCONTINUED DRUG PRODUCT LIST

CLONAZEPAM
TABLET, ORALLY DISINTEGRATING;ORAL
KLONOPIN RAPIDLY DISINTEGRATING
efficacy reasons**
0.25MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.5MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
1MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CLONIDINE
SUSPENSION, EXTENDED RELEASE;ORAL
CLONIDINE
TRIS PHARMA INC
EQ 0.09MG BASE/ML
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE
TRIS PHARMA INC
EQ 0.17MG BASE
EQ 0.26MG BASE
CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLONIDINE HYDROCHLORIDE
AM THERAP

DAVA PHARMS INC

DURAMED PHARMS BARR

INTERPHARM

PAR PHARM

SANDOZ

TEVA

WARNER CHILCOTT

WATSON LABS

0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.1MG
0.2MG
0.2MG
0.3MG
0.3MG

TABLET, EXTENDED RELEASE;ORAL

CLONIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH
0.2MG
0.2MG
ANCHEN PHARMS
0.1MG
0.2MG
CLONIDINE HYDROCHLORIDE
ANCHEN PHARMS
0.2MG
JENLOGA
CONCORDIA PHARMS INC
0.1MG
0.2MG

N020813 002 Dec 23, 1997

N020813 003 Dec 23, 1997

N020813 004 Dec 23, 1997

N020813 005 Dec 23, 1997

N022499 001 Dec 03, 2009

N022500 001 Dec 03, 2009

N022500 002 Dec 03, 2009

A070881
A070882
A070883
A071783
A071784
A071785
A071103
A071102
A071101
A071252
A071253
A071254
A070461
A070460
A070459
A070887
A070886
A071294
A070747
A070702
A070659
A072138
A072139
A072140
A070395
A070965
A070396
A070964
A070397
A070963

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jul
Jul
Jul
Apr
Apr
Apr
Aug
Aug
Aug
Oct
Oct
Oct
Jul
Jul
Jul
Aug
Aug
Aug
Jul
Jul
Jul
Jun
Jun
Jun
Mar
Jul
Mar
Jul
Mar
Jul

08,
08,
08,
05,
05,
05,
14,
14,
14,
01,
01,
01,
08,
08,
08,
31,
31,
31,
08,
08,
08,
13,
13,
13,
23,
08,
23,
08,
23,
08,

1986
1986
1986
1988
1988
1988
1986
1986
1986
1986
1986
1986
1986
1986
1986
1988
1988
1988
1986
1986
1986
1988
1988
1988
1987
1986
1987
1986
1987
1986

A202792
A203320
A202983
A202983

002
002
001
002

May
May
Apr
Apr

15,
15,
02,
02,

2015
2015
2014
2014

A202984 002 Sep 30, 2013

N022331 001 Sep 30, 2009
N022331 002 May 25, 2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-92(of 347)

DISCONTINUED DRUG PRODUCT LIST

CLONIDINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

KAPVAY

CONCORDIA PHARMS INC
0.2MG

CLORAZEPATE DIPOTASSIUM

CAPSULE;ORAL

CLORAZEPATE DIPOTASSIUM

ABLE

AM THERAP

DAVA PHARMS INC

GD SEARLE LLC

MYLAN

PUREPAC PHARM

QUANTUM PHARMICS

SANDOZ

USL PHARMA

WARNER CHILCOTT

WATSON LABS

TRANXENE

RECORDATI RARE

TABLET;ORAL

CLORAZEPATE DIPOTASSIUM

ABLE

AM THERAP

LEDERLE

PUREPAC PHARM

QUANTUM PHARMICS

SANDOZ

WARNER CHILCOTT

WATSON LABS

N022331 004 Sep 28, 2010

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

A071777
A071778
A071779
A071429
A071430
A071431
A071742
A071743
A071744
A071727
A071728
A071729
A071509
A071510
A071511
A071924
A071925
A071926
A071549
A071550
A071522
A072219
A072220
A072112
A071242
A071243
A071244
A071774
A071775
A071776
A071878
A071879
A071860

3.75MG

7.5MG

15MG

N017105 001

N017105 002

N017105 003

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

A071780
A071781
A071782
A071747
A071748
A071749
A072013
A072014
A072015
A072330
A072331
A072332
A071730
A071731
A071702
A072512
A072513
A072514
A071828
A071829
A071830
A071852
A071853
A071854

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jul
Jul
Jul
Jun
Jun
Jun
Dec
Dec
Dec
Dec
Dec
Dec
Oct
Oct
Oct
Apr
Apr
Apr
Sep
Sep
Sep
Aug
Aug
Aug
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Mar
Mar

14,
14,
14,
23,
23,
23,
14,
14,
14,
18,
18,
18,
19,
19,
19,
25,
25,
25,
12,
12,
12,
26,
26,
26,
23,
23,
23,
01,
01,
01,
15,
15,
15,

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1988

1988

1988

1988

1988

1988

1988

1988

1988

1987

1987

1987

1988

1988

1988

1988

1988

1988

Jun
Jun
Jun
Jun
Jun
Jun
Dec
Dec
Dec
Aug
Aug
Aug
Oct
Oct
Oct
May
May
May
Mar
Mar
Mar
Feb
Feb
Feb

26,
26,
26,
23,
23,
23,
15,
15,
15,
08,
08,
08,
26,
26,
26,
11,
11,
11,
03,
03,
03,
09,
09,
09,

1987

1987

1987

1987

1987

1987

1987

1987

1987

1988

1988

1988

1987

1987

1987

1990

1990

1990

1988

1988

1988

1988

1988

1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-93(of 347)

DISCONTINUED DRUG PRODUCT LIST

CLORAZEPATE DIPOTASSIUM

TABLET;ORAL

TRANXENE SD

RECORDATI RARE
CLOTRIMAZOLE

CREAM;TOPICAL

LOTRIMIN

SCHERING PLOUGH
MYCELEX

BAYER HEALTHCARE LLC
LOTION;TOPICAL

LOTRIMIN

SCHERING
SOLUTION;TOPICAL

LOTRIMIN

SCHERING PLOUGH
MYCELEX

BAYER HLTHCARE
TABLET;VAGINAL

GYNIX

TEVA PHARMS
MYCELEX-G

BAYER PHARMS
TROCHE/LOZENGE;ORAL

MYCELEX

BAYER HLTHCARE
CLOXACILLIN SODIUM

CAPSULE;ORAL

CLOXACILLIN SODIUM

APOTHECON
TEVA
CLOXAPEN

GLAXOSMITHKLINE

FOR SOLUTION;ORAL

CLOXACILLIN SODIUM

TEVA
TEGOPEN

APOTHECON
CLOZAPINE

TABLET;ORAL

CLOZAPINE

PAR PHARM

11.25MG
22.5MG

N017105 005

N017105 004

1%

N017619 001

1%

N018183 001

1%

N018813 001 Feb 17, 1984

1%

N017613 001

1%

N018181 001

100MG

A073249 001 Feb 13, 1998

500MG

N019069 001 Apr 19, 1985

10MG

N018713 001 Jun 17, 1983

EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE

A061452
A061452
A062240
A062240

001

002

001

002

EQ
EQ
EQ
EQ

250MG
250MG
500MG
500MG

BASE
BASE
BASE
BASE

A061806
A062233
A061806
A062233

001

001

002

002

EQ 125MG BASE/5ML
EQ 125MG BASE/5ML

A062268 001

A062978 001 Apr 06, 1989

EQ 125MG BASE/5ML
EQ 125MG BASE/5ML

A061453 001

N050192 001

25MG
100MG
SANDOZ
25MG
100MG
TABLET, ORALLY DISINTEGRATING;ORAL

FAZACLO ODT

JAZZ PHARMS III
50MG

A075162
A075162
A074546
A074546

001
002
001
002

Apr
Apr
Aug
Aug

26,
26,
30,
30,

2005

2005

1996

1996

N021590 003 Jun 03, 2005

COBALT CHLORIDE CO-57; CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR

N/A;N/A

RUBRATOPE-57 KIT

BRACCO
N/A;N/A;N/A;N/A
N016089 001

COBALT CHLORIDE CO-60; CYANOCOBALAMIN; CYANOCOBALAMIN CO-60; INTRINSIC FACTOR

N/A;N/A

RUBRATOPE-60 KIT

BRACCO
N/A;N/A;N/A;N/A
N016090 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-94(of 347)

DISCONTINUED DRUG PRODUCT LIST

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENERGAN VC W/ CODEINE

ANI PHARMS
10MG/5ML;5MG/5ML;6.25MG/5ML
N008306
PHERAZINE VC W/ CODEINE

HALSEY
10MG/5ML;5MG/5ML;6.25MG/5ML
A088870
PROMETHAZINE VC W/ CODEINE

CENCI
10MG/5ML;5MG/5ML;6.25MG/5ML
A088816
WOCKHARDT
10MG/5ML;5MG/5ML;6.25MG/5ML
A088896
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENERGAN W/ CODEINE

ANI PHARMS
10MG/5ML;6.25MG/5ML
PHERAZINE W/ CODEINE

HALSEY
10MG/5ML;6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

PHARM ASSOC
10MG/5ML;6.25MG/5ML
PROMETHAZINE W/ CODEINE

CENCI
10MG/5ML;6.25MG/5ML

005 Apr 02, 1984

001 Mar 02, 1987

001 Nov 22, 1985

001 Jan 04, 1985

N008306 004 Apr 02, 1984

A088739 001 Dec 23, 1988

A089647 001 Dec 22, 1988

A088814 001 Nov 22, 1985

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP;ORAL

ACTIFED W/ CODEINE

GLAXOSMITHKLINE
10MG/5ML;30MG/5ML;1.25MG/5ML
N012575 003 Apr 04, 1984

TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE

CENCI
10MG/5ML;30MG/5ML;1.25MG/5ML
A089018 001 Jul 23, 1986

TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE

WOCKHARDT
10MG/5ML;30MG/5ML;1.25MG/5ML
A088833 001 Nov 16, 1984

CODEINE SULFATE

SOLUTION;ORAL

CODEINE SULFATE

ROXANE

30MG/5ML

N202245 001 Jun 30, 2011

0.5MG;500MG

N012383 001

0.5MG;500MG

A085552 001

0.5MG;500MG
0.5MG;500MG
0.5MG;500MG
0.5MG;500MG

A083734
A084321
A083720
A086130

0.5MG;500MG
0.5MG;500MG

A086954 001

A083221 001

COLESEVELAM HYDROCHLORIDE

CAPSULE;ORAL

WELCHOL

DAIICHI SANKYO

375MG

N021141 001 May 26, 2000

COLISTIN SULFATE

SUSPENSION;ORAL

COLY-MYCIN S

PARKE DAVIS

EQ 25MG BASE/5ML

N050355 001

CONIVAPTAN HYDROCHLORIDE

INJECTABLE;IV (INFUSION)

VAPRISOL

CUMBERLAND PHARMS

20MG/4ML (5MG/ML)

N021697 001 Dec 29, 2005

COLCHICINE; PROBENECID

TABLET;ORAL

COLBENEMID

MERCK
PROBEN-C

WATSON LABS
PROBENECID AND COLCHICINE

ANI PHARMS INC
BEECHAM
IMPAX LABS
SANDOZ
PROBENECID W/ COLCHICINE

LEDERLE
WATSON LABS

COPPER

INTRAUTERINE DEVICE;INTRAUTERINE

CU-7

GD SEARLE LLC
89MG
TATUM-T

GD SEARLE LLC
120MG

001

001

002

001

N017408 001

N018205 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-95(of 347)

DISCONTINUED DRUG PRODUCT LIST

CORTICOTROPIN

INJECTABLE;INJECTION

ACTH

PARKEDALE

ACTHAR

SANOFI AVENTIS US

CORTICOTROPIN

ORGANICS LAGRANGE

WATSON LABS

H.P. ACTHAR GEL

MALLINCKRODT ARD

PURIFIED CORTROPHIN GEL

ORGANON USA INC

CORTICOTROPIN-ZINC HYDROXIDE

INJECTABLE;INJECTION

CORTROPHIN-ZINC

ORGANON USA INC

CORTISONE ACETATE

INJECTABLE;INJECTION

CORTISONE ACETATE

PHARMACIA AND UPJOHN

WATSON LABS

CORTONE

MERCK

TABLET;ORAL

CORTISONE ACETATE

BARR

ELKINS SINN

EVERYLIFE

HEATHER

IMPAX LABS

INWOOD LABS

IVAX SUB TEVA PHARMS

LANNETT

PANRAY

PHARMACIA AND UPJOHN

PUREPAC PHARM

VITARINE

WATSON LABS

WHITEWORTH TOWN PLSN

CORTONE

MERCK

COSYNTROPIN

SOLUTION;INTRAVENOUS

COSYNTROPIN

SANDOZ

CROMOLYN SODIUM

AEROSOL, METERED;INHALATION

INTAL

KING PFIZER

CAPSULE;INHALATION

INTAL

SANOFI AVENTIS US

25 UNITS/VIAL

40 UNITS/VIAL

N008317 002

N008317 004

25 UNITS/VIAL

40 UNITS/VIAL

N007504 002

N007504 003

40 UNITS/ML

80 UNITS/ML

40 UNITS/VIAL

N010831 001

N010831 002

A088772 001 Nov 21, 1984

40 UNITS/ML

N008372 006

40 UNITS/ML

80 UNITS/ML

N008975 001

N008975 002

40 UNITS/ML

N009854 001

25MG/ML

25MG/ML

25MG/ML

50MG/ML

50MG/ML

N008126
A083147
A085677
A083147
A085677

25MG/ML

50MG/ML

N007110 002

N007110 003

25MG

25MG

25MG

25MG

25MG

25MG

25MG

25MG

25MG

5MG

25MG

5MG

10MG

25MG

25MG

25MG

25MG

25MG

A083471
A080836
A084246
A085736
N009458
A080731
A080630
A083536
A080694
N008284
N008284
N008126
N008126
N008126
A080493
A080333
A085884
A080341

25MG

N007750 003

0.25MG/ML (0.25MG/ML)

N022028 001 Feb 21, 2008

0.8MG/INH

N018887 001 Dec 05, 1985

20MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N016990 001

002

003

001

004

002

001

001

001

001

001

001

001

001

001

002

001

003

004

001

001

001

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-96(of 347)

DISCONTINUED DRUG PRODUCT LIST

CROMOLYN SODIUM
CAPSULE;ORAL
GASTROCROM
UCB INC
CONCENTRATE;ORAL
CROMOLYN SODIUM
GENERA PHARMS
SOLUTION;INHALATION
CROMOLYN SODIUM
ACTAVIS MID ATLANTIC
APOTEX INC
PHARMASCIENCE INC
ROXANE
WATSON LABS
INTAL
KING PHARMS
SOLUTION/DROPS;OPHTHALMIC
CROMOLYN SODIUM
APOTEX INC
CROMOPTIC
KING PHARMS
OPTICROM
ALLERGAN

100MG

N019188 001 Dec 22, 1989

100MG/5ML

A090954 001 Dec 18, 2009

10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML

A075067
A075333
A075437
A075175
A076469

10MG/ML

N018596 001 May 28, 1982

4%

A075615 001 Jan 26, 2001

4%

A075088 001 Apr 27, 1999

4% **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N018155 001 Oct 03, 1984

5.2MG/SPRAY
5.2MG/SPRAY

A074800 001 Jul 26, 2001

A077976 001 Sep 07, 2007

5.2MG/SPRAY **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N020463 001 Jan 03, 1997

CRYPTENAMINE ACETATES
INJECTABLE;INJECTION
UNITENSEN
MEDPOINTE PHARM HLC

260CSR UNIT/ML

N008814 001

CRYPTENAMINE TANNATES
TABLET;ORAL
UNITENSEN
MEDPOINTE PHARM HLC

260CSR UNIT

N009217 001

CUPRIC SULFATE
INJECTABLE;INJECTION
CUPRIC SULFATE
ABRAXIS PHARM

EQ 0.4MG COPPER/ML

N019350 001 May 05, 1987

0.5MG/INH

N019722 001 Nov 05, 1996

1MG/ML

N006798 001

0.1MG/ML
1MG/ML

A080855 001
A080855 002

0.1MG/ML
1MG/ML

A083013 001
A083064 001

0.03MG/ML
0.1MG/ML
1MG/ML
1MG/ML
0.03MG/ML
0.1MG/ML
1MG/ML
1MG/ML
0.1MG/ML
0.03MG/ML

A080510
A080510
A080510
A087969
A080689
A080689
A080689
A080515
A080557
A080668

SPRAY, METERED;NASAL
CROMOLYN SODIUM
ACTAVIS MID ATLANTIC
HH AND P
NASALCROM
BLACKSMITH BRANDS

CYANOCOBALAMIN
GEL, METERED;NASAL
NASCOBAL
PAR PHARM
INJECTABLE;INJECTION
BERUBIGEN
PHARMACIA AND UPJOHN
BETALIN 12
LILLY
COBAVITE
WATSON LABS
CYANOCOBALAMIN
ABRAXIS PHARM

AKORN
DELL LABS

EUROHLTH INTL SARL

FRESENIUS KABI USA
LUITPOLD

001
001
001
001
001

Jul
Apr
Apr
Sep
Jun

19,
30,
21,
30,
17,

1999
2002
2000
1999
2005

003
001
002
001 Nov 10, 1983
001
002
003
002
002
001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-97(of 347)

DISCONTINUED DRUG PRODUCT LIST

CYANOCOBALAMIN

INJECTABLE;INJECTION

CYANOCOBALAMIN

LYPHOMED

MYLAN INSTITUTIONAL

SANOFI AVENTIS US

SOLOPAK

WARNER CHILCOTT

WATSON LABS

1MG/ML

1MG/ML

1MG/ML

1MG/ML

1MG/ML

0.1MG/ML

0.1MG/ML

1MG/ML

1MG/ML

0.1MG/ML

1MG/ML

A083075
A040451
A080564
A087551
N007085
A080573
A083120
A080573
A083120
A080554
A080554

1MG/ML

N006668 010

0.03MG/ML

0.05MG/ML

0.1MG/ML

0.12MG/ML

1MG/ML

N010791
N010791
N010791
N010791
N010791

0.1MG/ML

1MG/ML

1MG/ML

N006799 002

N006799 004

N006799 010 Apr 28, 1988

1MG/ML

A080570 002

1MG/ML

N007012 002

25MCG/SPRAY

N022102 001 Jul 27, 2007

1MG

A084264 001

CYANOCOBALAMIN CO-57

CAPSULE;ORAL

RUBRATOPE-57

BRACCO

0.5-1uCi

N016089 002

CYANOCOBALAMIN CO-60

CAPSULE;ORAL

RUBRATOPE-60

BRACCO

0.5-1uCi

N016090 002

WYETH AYERST

REDISOL

MERCK

RUBIVITE

BEL MAR

RUBRAMIN PC

BRISTOL MYERS SQUIBB

RUVITE

SAVAGE LABS

VI-TWEL

BAYER HLTHCARE

SPRAY, METERED;NASAL

CALOMIST

PAR PHARM

TABLET;ORAL

CYANOCOBALAMIN

WEST WARD

001

001 Sep 23, 2003

001

001 Feb 29, 1984

002

002

001

001

002

001

002

004

001

002

005

003

CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58

N/A;N/A

DICOPAC KIT

GE HEALTHCARE
N/A;N/A;N/A

N017406 001

CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR

N/A;N/A

CYANOCOBALAMIN CO 57 SCHILLING TEST KIT

MALLINCKRODT
0.1MG;0.5uCi;60MG

N016635 001

CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE

INJECTABLE;INJECTION

DEPINAR

ARMOUR PHARM

0.5MG/ML;2.3MG/ML;1MG/ML

N011208 001

CYCLACILLIN

FOR SUSPENSION;ORAL

CYCLAPEN-W

WYETH AYERST

TABLET;ORAL

CYCLACILLIN

TEVA

CYCLAPEN-W

WYETH AYERST

125MG/5ML

250MG/5ML

500MG/5ML

N050508 001

N050508 002

N050508 003

250MG

500MG

A062895 001 Aug 04, 1988

A062895 002 Aug 04, 1988

250MG

500MG

N050509 001

N050509 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-98(of 347)

DISCONTINUED DRUG PRODUCT LIST

CYCLIZINE LACTATE
INJECTABLE;INJECTION
MAREZINE
GLAXOSMITHKLINE

50MG/ML

CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
PROSAM LABS
5MG
SANDOZ
5MG
10MG
10MG
WATSON LABS
10MG
10MG
FLEXERIL
JANSSEN RES AND DEV
5MG
10MG
CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AK-PENTOLATE
AKORN
1%
AKPENTOLATE
AKORN
2%
CYCLOPENTOLATE HYDROCHLORIDE
ALCON PHARMS LTD
1%
SOLA BARNES HIND
1%
1%
PENTOLAIR
PHARMAFAIR
0.5%
1%
CYCLOPHOSPHAMIDE
INJECTABLE;INJECTION
CYCLOPHOSPHAMIDE
BAXTER HLTHCARE

CYTOXAN
BAXTER HLTHCARE
CYTOXAN (LYOPHILIZED)
BAXTER HLTHCARE

LYOPHILIZED CYTOXAN
BAXTER HLTHCARE
NEOSAR
BEDFORD

TEVA PARENTERAL

TABLET;ORAL
CYTOXAN
BAXTER HLTHCARE
CYCLOSPORINE
CAPSULE;ORAL
NEORAL
NOVARTIS
SOLUTION;ORAL
CYCLOSPORINE
APOTEX INC

N009495 001

A077291
A072854
A072854
A073683
A073143
A074436

001
002
001
001
001
001

Feb
Feb
Nov
Feb
Nov
Nov

03,
03,
19,
26,
27,
30,

2006
2006
1991
1993
1991
1994

N017821 001
N017821 002

A085555 001
A040165 001 Jan 13, 1997
A089162 001 Jan 24, 1991
A084150 001
A084863 001
A088643 001 Feb 09, 1987
A088150 001 Feb 25, 1983

100MG/VIAL
200MG/VIAL
500MG/VIAL
1GM/VIAL

A088371
A088372
A088373
A088374

001
001
001
001

100MG/VIAL
200MG/VIAL

N012142 001
N012142 002

500MG/VIAL
1GM/VIAL
2GM/VIAL

N012142 008 Jan 04, 1984

N012142 010 Sep 24, 1985
N012142 009 Dec 10, 1985

100MG/VIAL
200MG/VIAL

N012142 006 Dec 05, 1985

N012142 007 Dec 10, 1985

100MG/VIAL
200MG/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
100MG/VIAL
200MG/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL

A087442
A087442
A087442
A087442
A087442
A040015
A040015
A040015
A040015
A040015

25MG
50MG

N012141 002
N012141 001

50MG

N050715 003 Jul 14, 1995

100MG/ML

A065167 001 Jan 05, 2005

001
002
003
004
005
001
002
003
004
005

Jul
Jul
Jul
Sep

Feb
Feb
Feb
Jul
Mar
Apr
Apr
Apr
Apr
Apr

03,
03,
03,
24,

16,
16,
16,
08,
30,
29,
29,
29,
29,
29,

1986
1986
1986
1986

1982
1982
1982
1983
1989
1993
1993
1993
1993
1993

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-99(of 347)

DISCONTINUED DRUG PRODUCT LIST

CYCLOTHIAZIDE
TABLET;ORAL
ANHYDRON
LILLY
FLUIDIL
PHARMACIA AND UPJOHN
CYCRIMINE HYDROCHLORIDE
TABLET;ORAL
PAGITANE
LILLY

2MG

N013157 002

2MG

N018173 001

1.25MG
2.5MG

N008951 001
N008951 002

CYPROHEPTADINE HYDROCHLORIDE
SYRUP;ORAL
CYPROHEPTADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC
2MG/5ML
HALSEY
2MG/5ML
MORTON GROVE
2MG/5ML
NASKA
2MG/5ML
PERIACTIN
MERCK
2MG/5ML
TABLET;ORAL
CYPROHEPTADINE HYDROCHLORIDE
AM THERAP
4MG
ASCOT
4MG
DURAMED PHARMS BARR
4MG
HALSEY
4MG
KV PHARM
4MG
MD PHARM
4MG
MYLAN
4MG
PIONEER PHARMS
4MG
PLIVA
4MG
SANDOZ
4MG
SUPERPHARM
4MG
TG UNITED LABS
4MG
VITARINE
4MG
WATSON LABS
4MG
4MG
4MG
PERIACTIN
MERCK
4MG
CYSTEINE HYDROCHLORIDE
INJECTABLE;INJECTION
CYSTEINE HYDROCHLORIDE
HOSPIRA

CYTARABINE
INJECTABLE;INJECTION
CYTARABINE
TEVA PARENTERAL

DACARBAZINE
INJECTABLE;INJECTION
DACARBAZINE
ABRAXIS PHARM
DALFOPRISTIN; QUINUPRISTIN
INJECTABLE;IV (INFUSION)
SYNERCID
KING PHARMS

A086833
A089199
A087001
A089021

001
001 Jul 03, 1986
001 Nov 04, 1982
001 Dec 21, 1987

N013220 002

A088798
A087685
A088232
A089057
A086737
A087566
A086678
A087839
A088205
A086808
A087405
A088212
A087284
A085245
A086165
A086580

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Feb
Oct
Oct
Jul

15,
25,
25,
03,

1985
1982
1983
1986

Nov 10, 1982

Feb 08, 1984
Jul 26, 1983

May 26, 1983

N012649 001

7.25% **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N019523 001 Oct 22, 1986

100MG/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL

N016793
N016793
N016793
N016793

100MG/VIAL
200MG/VIAL

A070962 001 Aug 28, 1986

A070990 001 Aug 28, 1986

420MG/VIAL;180MG/VIAL

N050748 002 Aug 24, 2000

001
002
003 Dec 21, 1987
004 Dec 21, 1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

DALTEPARIN SODIUM

INJECTABLE;INJECTION

FRAGMIN

PFIZER INC
INJECTABLE;SUBCUTANEOUS

FRAGMIN

PFIZER INC

6-100(of 347)

7,500 IU/0.75ML

N020287 008 Apr 04, 2002

10,000IU/0.4ML (25,000IU/ML)
95,000IU/9.5ML (10,000IU/ML)

N020287 002 May 01, 2007

N020287 007 Apr 04, 2002

750 UNITS/0.6ML

N020430 001 Dec 24, 1996

200MG

A071569 001 Dec 30, 1987

50MG
100MG
200MG

N017557 003

N017557 004

N017557 002

DAPIPRAZOLE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

DAPIPRAZOLE HYDROCHLORIDE

FERA PHARMS

0.5%

N019849 001 Dec 31, 1990

DAPTOMYCIN

INJECTABLE;IV (INFUSION)

CUBICIN

CUBIST

250MG/VIAL

N021572 001 Sep 12, 2003

EQ 300MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 400MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N021976 001 Jun 23, 2006

DANAPAROID SODIUM

INJECTABLE;INJECTION

ORGARAN

ASPEN GLOBAL INC
DANAZOL

CAPSULE;ORAL

DANAZOL

AM THERAP
DANOCRINE

SANOFI AVENTIS US

DARUNAVIR ETHANOLATE

TABLET;ORAL

PREZISTA

JANSSEN PRODS

DAUNORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

CERUBIDINE

SANOFI AVENTIS US
EQ 20MG BASE/VIAL
WYETH AYERST
EQ 20MG BASE/VIAL
DAUNORUBICIN HYDROCHLORIDE

TEVA PARENTERAL
EQ 20MG BASE/VIAL
EQ 50MG BASE/VIAL
DECAMETHONIUM BROMIDE

INJECTABLE;INJECTION

SYNCURINE

GLAXOSMITHKLINE
DEFEROXAMINE MESYLATE

INJECTABLE;INJECTION

DEFEROXAMINE MESYLATE

WATSON LABS
DEMECARIUM BROMIDE

SOLUTION/DROPS;OPHTHALMIC

HUMORSOL

MERCK
DEMECLOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL

DECLOMYCIN

LEDERLE
SYRUP;ORAL

DECLOMYCIN

LEDERLE

N021976 003 Oct 21, 2008

A061876 001

N050484 001

A064212 001 Jun 23, 1998

A064212 002 May 03, 1999

1MG/ML

N006931 002

500MG/VIAL
2GM/VIAL

A076806 001 Mar 31, 2006

A076806 002 Mar 31, 2006

0.125%
0.25%

N011860 002

N011860 001

150MG

N050262 001

75MG/5ML

N050257 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-101(of 347)

DISCONTINUED DRUG PRODUCT LIST

DEMECLOCYCLINE HYDROCHLORIDE

TABLET;ORAL

DECLOMYCIN

COREPHARMA

DESERPIDINE

TABLET;ORAL

HARMONYL

ABBVIE

75MG

150MG

300MG

N050261 001

N050261 002

N050261 003

0.1MG

0.25MG

N010796 001

N010796 002

DESERPIDINE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ORETICYL 25

ABBVIE

0.125MG;25MG

ORETICYL 50

ABBVIE

0.125MG;50MG

ORETICYL FORTE

ABBVIE

0.25MG;25MG

DESERPIDINE; METHYCLOTHIAZIDE

TABLET;ORAL

ENDURONYL

ABBOTT

0.25MG;5MG

ENDURONYL FORTE

ABBOTT

0.5MG;5MG

METHYCLOTHIAZIDE AND DESERPIDINE

WATSON LABS

0.25MG;5MG

0.5MG;5MG

DESIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

PERTOFRANE

SANOFI AVENTIS US

TABLET;ORAL

DESIPRAMINE HYDROCHLORIDE

ANI PHARMS INC

USL PHARMA

DESLANOSIDE

INJECTABLE;INJECTION

CEDILANID-D

NOVARTIS

N012148 001

N012148 003

N012148 002

N012775 001

N012775 002

A088486 001 Aug 10, 1984

A088452 001 Aug 10, 1984

25MG

50MG

N013621 001

N013621 002

100MG

25MG

50MG

75MG

100MG

A071803
A071864
A071865
A071866
A071867

0.2MG/ML

N009282 002

DESMOPRESSIN ACETATE

INJECTABLE;INJECTION

DDAVP

FERRING PHARMS INC

0.015MG/ML

DESMOPRESSIN ACETATE

BEDFORD

0.004MG/ML

DESMOPRESSIN ACETATE PRESERVATIVE FREE

BEDFORD

0.004MG/ML

SOLUTION;NASAL

CONCENTRAID

FERRING

0.01%

SPRAY, METERED;NASAL

DDAVP

FERRING PHARMS INC

0.01MG/SPRAY

STIMATE

CSL BEHRING

0.15MG/SPRAY

DESOGESTREL; ETHINYL ESTRADIOL

TABLET;ORAL-21

DESOGEN

ORGANON USA INC

0.15MG;0.03MG

DESOGESTREL AND ETHINYL ESTRADIOL

DURAMED PHARMS BARR
0.15MG;0.03MG

ORTHO-CEPT

JANSSEN PHARMS
0.15MG;0.03MG

001
001
001
001
001

May
Sep
Sep
Sep
Sep

29,
09,
09,
09,
09,

1997

1987

1987

1987

1987

N018938 002 Apr 25, 1995

A074575 001 Feb 18, 2000

A074574 001 Feb 18, 2000

N019776 001 Dec 26, 1990

N017922 002 Feb 06, 1989

N020355 001 Mar 07, 1994

N020071 001 Dec 10, 1992

A075256 001 Aug 12, 1999

N020301 001 Dec 14, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

DESOGESTREL; ETHINYL ESTRADIOL

TABLET;ORAL-28

MIRCETTE

TEVA BRANDED PHARM

0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

DESOXIMETASONE

CREAM;TOPICAL

TOPICORT

TARO PHARMS NORTH

TOPICORT LP

TARO PHARMS NORTH

GEL;TOPICAL

TOPICORT

TARO PHARMS NORTH

OINTMENT;TOPICAL

DESOXIMETASONE

ALTANA

TOPICORT

TARO PHARMS NORTH

DESOXYCORTICOSTERONE ACETATE

INJECTABLE;INJECTION

DOCA

ORGANON USA INC

PELLET;IMPLANTATION

PERCORTEN

NOVARTIS

DESOXYCORTICOSTERONE PIVALATE

INJECTABLE;INJECTION

PERCORTEN

NOVARTIS

6-102(of 347)

N020713 001 Apr 22, 1998

0.25% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N017856 001

0.05%

N018309 001

0.05%

N018586 001 Mar 29, 1982

0.25%

A073440 001 Apr 01, 1998

0.25%

N018763 001 Sep 30, 1983

5MG/ML

N001104 001

125MG

N005151 001

25MG/ML

N008822 001

DESVENLAFAXINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL

DESVENLAFAXINE

TEVA PHARMS USA

EQ 50MG BASE

EQ 100MG BASE

N205208 001 Oct 11, 2013

N205208 002 Oct 11, 2013

DEXAMETHASONE

AEROSOL;TOPICAL

AEROSEB-DEX

ALLERGAN HERBERT

0.01% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

A083296 002

0.04% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N012731 002

0.5MG/5ML

N012376 002

0.5MG/5ML

A088997 001 Oct 10, 1986

0.5MG/5ML

N012674 001

0.1%

N013538 001

0.1%

A089170 001 May 09, 1989

0.25MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N011664 004

DECASPRAY

MERCK

ELIXIR;ORAL

DECADRON

MERCK

DEXAMETHASONE

ALPHARMA US PHARMS

HEXADROL

ORGANON USA INC

GEL;TOPICAL

DECADERM

MERCK

SUSPENSION/DROPS;OPHTHALMIC

DEXAMETHASONE

WATSON LABS

TABLET;ORAL

DECADRON

MERCK

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-103(of 347)

DISCONTINUED DRUG PRODUCT LIST

DEXAMETHASONE

TABLET;ORAL

DECADRON

DEXAMETHASONE
IMPAX LABS
MUTUAL PHARM

PAR PHARM
PHOENIX LABS NY
PVT FORM
ROXANE
SANDOZ
UPSHER SMITH
WATSON LABS

WHITEWORTH TOWN PLSN

DEXONE 0.5
SOLVAY
DEXONE 0.75
SOLVAY
DEXONE 1.5
SOLVAY
DEXONE 4
SOLVAY
HEXADROL
ORGANON USA INC

DEXAMETHASONE ACETATE
INJECTABLE;INJECTION
DECADRON-LA
MERCK

DEXAMETHASONE ACETATE
WATSON LABS

0.5MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.75MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
1.5MG
4MG
6MG

N011664 001

0.75MG
0.25MG
0.25MG
0.5MG
0.5MG
0.75MG
0.75MG
1.5MG
1.5MG
0.25MG
0.75MG
0.75MG
0.25MG
0.75MG
0.75MG
1.5MG
0.25MG
0.5MG
0.75MG
0.75MG
0.75MG
1.5MG
1.5MG
0.75MG

A085376
A084013
A084764
A084084
A084766
A084081
A084765
A084086
A084763
A088149
A083806
A083420
A084614
A080399
A087534
A087533
A085455
A085458
A080968
A084457
A085818
A085456
A085840
A084327

0.5MG

A084991 001

0.75MG

A084993 001

1.5MG

A084990 001

4MG

A084992 001

0.5MG
0.75MG
1.5MG
4MG

N012675
N012675
N012675
N012675

EQ 8MG BASE/ML **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N016675 001

EQ 8MG BASE/ML
EQ 16MG BASE/ML

A084315 001
A087711 001 May 24, 1982

DEXAMETHASONE SODIUM PHOSPHATE

AEROSOL;NASAL
DEXACORT
UCB INC
EQ 0.1MG PHOSPHATE/INH
AEROSOL, METERED;INHALATION
DEXACORT
UCB INC
EQ 0.1MG PHOSPHATE/INH
CREAM;TOPICAL
DECADRON
MERCK
EQ 0.1% PHOSPHATE

N011664 002

N011664 003
N011664 005
N011664 006 Jul 30, 1982
001
001
001
001
001
001
001
001
001
001 Apr 28, 1983
001
001
001
001
001
001
001
001
001
001
001
001
001
001

004
007
009
010

N014242 001

N013413 001

N011983 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-104(of 347)

DISCONTINUED DRUG PRODUCT LIST

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

DECADRON

MERCK

EQ 4MG PHOSPHATE/ML

EQ 24MG PHOSPHATE/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

DEXACEN-4

CENT PHARMS
EQ 4MG PHOSPHATE/ML

DEXAMETHASONE

ABRAXIS PHARM
EQ 4MG PHOSPHATE/ML

FRESENIUS KABI USA

EQ 10MG PHOSPHATE/ML

DEXAMETHASONE SODIUM PHOSPHATE

AKORN

EQ 4MG PHOSPHATE/ML

BEL MAR

EQ 4MG PHOSPHATE/ML

DELL LABS

EQ 4MG PHOSPHATE/ML

EUROHLTH INTL SARL

EQ 4MG PHOSPHATE/ML

INTL MEDICATION

EQ 20MG PHOSPHATE/ML

LYPHOMED

EQ 4MG PHOSPHATE/ML

TEVA PARENTERAL

EQ 4MG PHOSPHATE/ML

EQ 10MG PHOSPHATE/ML

WATSON LABS

EQ 4MG PHOSPHATE/ML

EQ 4MG PHOSPHATE/ML

EQ 4MG PHOSPHATE/ML

EQ 10MG PHOSPHATE/ML

EQ 24MG PHOSPHATE/ML

WYETH AYERST

EQ 4MG PHOSPHATE/ML

HEXADROL

ORGANON USA INC

EQ 4MG PHOSPHATE/ML

EQ 10MG PHOSPHATE/ML

EQ 20MG PHOSPHATE/ML

OINTMENT;OPHTHALMIC

DECADRON

MERCK

EQ 0.05% PHOSPHATE

DEXAIR

PHARMAFAIR

EQ 0.05% PHOSPHATE

MAXIDEX

ALCON

EQ 0.05% PHOSPHATE

SOLUTION/DROPS;OPHTHALMIC

DEXAIR

PHARMAFAIR

EQ 0.1% PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE

SOLA BARNES HIND
EQ 0.1% PHOSPHATE

EQ 0.1% PHOSPHATE

SOLUTION/DROPS;OPHTHALMIC, OTIC

DECADRON

MERCK
EQ 0.1% PHOSPHATE

SOLUTION/DROPS;OTIC

DEXAMETHASONE SODIUM PHOSPHATE

AKORN
EQ 0.1% PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DECADRON W/ XYLOCAINE

MERCK
EQ 4MG PHOSPHATE/ML;10MG/ML

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

OINTMENT;OPHTHALMIC

NEODECADRON

MERCK

EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM

SOLUTION/DROPS;OPHTHALMIC

NEODECADRON

MERCK

EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

BAUSCH AND LOMB
EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

ALCON PHARMS LTD
EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

PHARMAFAIR
EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

N012071 002

N012071 004

A084342 001

A088448 001 Jan 25, 1984

A088469 001 Jan 25, 1984

A084493
A084752
A083161
A084282
A088522
A087065
A081125
A081126
A083702
A084355
A089169
A087668
A085606
A085641

001

001

001

001

001
001

001
001
001

001

001
001
001

001

Feb 17, 1984

Aug 31, 1990

Aug 31, 1990

Apr 09, 1986

Jul 01, 1982

N014694 002

N014694 003

N014694 004

N011977 001

A088071 001 Dec 28, 1982

A083342 001

A088433 001 Dec 15, 1983

A084170 001

A084173 001

N011984 001

A084855 001

N013334 002

N050324 001

N050322 001

A064055 001 Oct 30, 1995

A062714 001 Jul 21, 1986

A062539 001 Jan 10, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

DEXACIDIN

NOVARTIS

0.1%;EQ 3.5MG BASE/GM;10,000
DEXASPORIN

PHARMAFAIR

0.1%;EQ 3.5MG BASE/GM;10,000
SUSPENSION/DROPS;OPHTHALMIC

DEXACIDIN

NOVARTIS

0.1%;EQ 3.5MG BASE/ML;10,000
DEXASPORIN

PHARMAFAIR

0.1%;EQ 3.5MG BASE/ML;10,000
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

ALCON PHARMS LTD
0.1%;EQ 3.5MG BASE/ML;10,000
DEXBROMPHENIRAMINE MALEATE

SYRUP;ORAL

DISOMER

SCHERING

TABLET;ORAL

DISOMER

SCHERING

6-105(of 347)

UNITS/GM

A062566 001
Feb 22, 1985

UNITS/GM

A062411 001
May 16, 1983

UNITS/ML

A062544 001
Oct 29, 1984

UNITS/ML

A062428 001
May 18, 1983

UNITS/ML

A062721 001
Nov 17, 1986

2MG/5ML

N011814 002

2MG

N011814 001

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET;ORAL

DISOPHROL

SCHERING

2MG;60MG

TABLET, EXTENDED RELEASE;ORAL

BROMPHERIL

COPLEY PHARM

6MG;120MG

DISOBROM

SANDOZ

6MG;120MG

DISOPHROL

SCHERING PLOUGH

6MG;120MG

DRIXORAL

SCHERING PLOUGH

6MG;120MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

RESPORAL

PIONEER PHARMS

6MG;120MG

DEXCHLORPHENIRAMINE MALEATE

SYRUP;ORAL

POLARAMINE

SCHERING

2MG/5ML

TABLET;ORAL

DEXCHLORPHENIRAMINE MALEATE

ANI PHARMS INC

2MG

POLARAMINE

SCHERING

2MG

DEXTROAMPHETAMINE SULFATE

CAPSULE;ORAL

DEXAMPEX

TEVA

15MG

CAPSULE, EXTENDED RELEASE;ORAL

DEXTROAMPHETAMINE SULFATE

ABLE

5MG

10MG

15MG

ELIXIR;ORAL

DEXEDRINE

GLAXOSMITHKLINE

5MG/5ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

TABLET;ORAL

DEXAMPEX

TEVA

5MG

10MG

DEXEDRINE

GLAXOSMITHKLINE

5MG

DEXTROAMPHETAMINE SULFATE

HALSEY

10MG

LANNETT

5MG

N012394 002

A089116 001
Jan 22, 1987

A070770 001
Sep 30, 1991

N013483 004
Sep 13, 1982

N013483 003
Sep 13, 1982

A089139 001
Jun 16, 1988

A086837 001
Jul 19, 1982

A088682 001
Jan 17, 1986

A086835 001

A085355 001

A076814 001
Aug 25, 2004

A076814 002
Aug 25, 2004

A076814 003
Aug 25, 2004

A083902 001

A083735 001

A083735 002

A084935 001

A083930 001

A083903 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-106(of 347)

DISCONTINUED DRUG PRODUCT LIST

DEXTROAMPHETAMINE SULFATE

TABLET;ORAL

DEXTROAMPHETAMINE SULFATE

MAST MM

NESHER PHARMS

PUREPAC PHARM

SANDOZ

VINTAGE PHARMS LLC

VITARINE

DEXTROSTAT

SHIRE

FERNDEX

FERNDALE LABS

DEXTROMETHORPHAN HYDROBROMIDE;
SYRUP;ORAL

PHERAZINE DM

HALSEY
PROMETHAZINE HYDROCHLORIDE
ANI PHARMS
PROMETHAZINE HYDROCHLORIDE
AMNEAL PHARMS
TRIS PHARMA INC

10MG

15MG

5MG

5MG

10MG

5MG

5MG

10MG

5MG

5MG

10MG

A083903
A085652
A086521
A040365
A040367
A084125
A085370
A085371
A040299
A084986
A085892

003

001

001

001 Oct 31, 2002

001 Oct 31, 2002

001

001

001

001 May 13, 1999

001

001

5MG

10MG

A084051 001

A084051 002

5MG

A084001 001

PROMETHAZINE HYDROCHLORIDE

15MG/5ML;6.25MG/5ML

AND DESTROMETHORPHAN HYDROBROMIDE

15MG/5ML;6.25MG/5ML

AND DEXTROMETHORPHAN HYDROBROMIDE

15MG/5ML;6.25MG/5ML
15MG/5ML;6.25MG/5ML

DEXTROSE
INJECTABLE;INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML

MILES
10GM/100ML

DEXTROSE 2.5% IN PLASTIC CONTAINER

B BRAUN
2.5GM/100ML

2.5GM/100ML

DEXTROSE 38.5% IN PLASTIC CONTAINER

ABBOTT
38.5GM/100ML

DEXTROSE 5% IN PLASTIC CONTAINER

DHL
5GM/100ML

DEXTROSE 50% IN PLASTIC CONTAINER

HOSPIRA
50GM/100ML

DEXTROSE 60%

B BRAUN
60GM/100ML

DEXTROSE 60% IN PLASTIC CONTAINER

B BRAUN
60GM/100ML

BAXTER HLTHCARE
60GM/100ML

HOSPIRA
60GM/100ML

DEXTROSE 7.7% IN PLASTIC CONTAINER

B BRAUN
7.7GM/100ML

A088913 001 Mar 02, 1987

N011265 002 Apr 02, 1984

A090575 001 Feb 08, 2011

A091687 001 Jun 28, 2012

N018046 001

N018504 001

N018358 001

N019626 001 Feb 02, 1988

N018923 001 Sep 19, 1984

N019971 001 Sep 28, 1995

N019894 001 Dec 26, 1989

N017995 002 Sep 22, 1982

N017995 001

N020047 002 Jul 02, 1991

N019346 001 Jan 25, 1985

N019626 003 Feb 02, 1988

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

INJECTABLE;INJECTION

ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;31MG/100ML;130MG/100ML;26MG/1
N019025 001 Dec 27, 1984

00ML;320MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;30MG/100ML;97MG/100ML;220MG/1
N018273 001

00ML;140MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM

GLUCONATE

INJECTABLE;INJECTION

ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;30MG/100ML;37MG/100ML;370MG/1

N019843 001 Aug 09, 1993

00ML;530MG/100ML;500MG/100ML

ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;30MG/100ML;37MG/100ML;370MG/1

N018274 001

00ML;530MG/100ML;500MG/100ML

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

6-107(of 347)

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM

GLUCONATE

INJECTABLE;INJECTION

PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5GM/100ML;30MG/100ML;37MG/100ML;368MG/1
N017451 001
00ML;526MG/100ML;502MG/100ML
DEXTROSE; POTASSIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;37MG/100ML
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;75MG/100ML
5GM/100ML;75MG/100ML
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;110MG/100ML
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;150MG/100ML
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;220MG/100ML
5GM/100ML;220MG/100ML
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;300MG/100ML

N019699 001 Sep 29, 1989

N018744 001 Nov 09, 1982
N019699 002 Sep 29, 1989
N019699 003 Sep 29, 1989
N018744 002 Nov 09, 1982
N018744 003 Nov 09, 1982
N019699 005 Sep 29, 1989
N018744 004 Nov 09, 1982

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC

ANHYDROUS

INJECTABLE;INJECTION

IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA
5GM/100ML;111MG/100ML;256MG/100ML;146MG
N019514 001 May 08, 1986

/100ML;207MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;150MG/100ML;130MG/100ML;280MG
N018270 001

/100ML;91MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER

BAXTER HLTHCARE
5GM/100ML;205MG/100ML;100MG/100ML;120MG
N018840 001 Jun 29, 1983

/100ML;220MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%

B BRAUN
5GM/100ML;75MG/100ML;200MG/100ML
N018268 009

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;150MG/100ML;200MG/100ML
N018268 004

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;220MG/100ML;200MG/100ML
N018268 005

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;300MG/100ML;200MG/100ML
N018268 006

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;75MG/100ML;330MG/100ML
N018268 011 Jan 18,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;150MG/100ML;330MG/100ML
N018268 012 Jan 18,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;220MG/100ML;330MG/100ML
N018268 013 Jan 18,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;300MG/100ML;330MG/100ML
N018268 014 Jan 18,
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%

B BRAUN
5GM/100ML;75MG/100ML;450MG/100ML
N018268 010

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;150MG/100ML;450MG/100ML
N018268 001

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;220MG/100ML;450MG/100ML
N018268 002

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;300MG/100ML;450MG/100ML
N018268 003

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

BAXTER HLTHCARE
5GM/100ML;224MG/100ML;450MG/100ML
N018008 003

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER

BAXTER HLTHCARE
5GM/100ML;300MG/100ML;450MG/100ML
N018008 001

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

BAXTER HLTHCARE
5GM/100ML;75MG/100ML;450MG/100ML
N018008 002

1986

1986

1986

1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-108(of 347)

DISCONTINUED DRUG PRODUCT LIST

DEXTROSE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;200MG/100ML

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;450MG/100ML

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
10GM/100ML;900MG/100ML

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
2.5GM/100ML;450MG/100ML

HOSPIRA
2.5GM/100ML;450MG/100ML

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
2.5GM/100ML;900MG/100ML

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ABBOTT
3.3GM/100ML;300MG/100ML

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;110MG/100ML

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;200MG/100ML

MILES
5GM/100ML;200MG/100ML

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

ABBOTT
5GM/100ML;225MG/100ML

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ABBOTT
5GM/100ML;300MG/100ML

MILES
5GM/100ML;300MG/100ML

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML;330MG/100ML

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

ABBOTT
5GM/100ML;450MG/100ML

B BRAUN
5GM/100ML;450MG/100ML

MILES
5GM/100ML;450MG/100ML

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

ABBOTT
5GM/100ML;900MG/100ML

B BRAUN
5GM/100ML;900MG/100ML

MILES
5GM/100ML;900MG/100ML

DEXTROTHYROXINE SODIUM

TABLET;ORAL

CHOLOXIN

ABBVIE

DEZOCINE

INJECTABLE;INJECTION

DALGAN

ASTRAZENECA

DIATRIZOATE MEGLUMINE

INJECTABLE;INJECTION

ANGIOVIST 282

BAYER HLTHCARE
CARDIOGRAFIN

BRACCO
DIATRIZOATE MEGLUMINE

BRACCO
HYPAQUE

GE HEALTHCARE
RENO-60

BRACCO
RENO-DIP

BRACCO
UROVIST MEGLUMINE DIU/CT

BAYER HLTHCARE
SOLUTION;URETERAL

RENO-30

BRACCO
UROVIST CYSTO

BAYER HLTHCARE

N018386 001

N018229 001

N018047 001

N018030 001

N018096 001

N018376 001

N018055 001

N018030 005

N018030 004

N018399 001

N019482 001 Oct 04, 1985

N019486 001 Oct 04, 1985

N018501 001

N018030 003

N019484 001 Oct 04, 1985

N018030 002

N018400 001

N019483 001 Oct 04, 1985

N018026 001

N018500 001

1MG

2MG

4MG

6MG

N012302
N012302
N012302
N012302

005

002

004

006

5MG/ML

10MG/ML

15MG/ML

N019082 001 Dec 29, 1989

N019082 002 Dec 29, 1989

N019082 003 Dec 29, 1989

60%

A087726 001 Sep 23, 1982

85%

N011620 002

76%

N010040 017

30%

60%

N016403 002

N016403 001

60%

N010040 016

30%

N010040 012

30%

A087739 001 Sep 23, 1982

30%

N010040 021

30%

A087729 001 Sep 23, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

DIATRIZOATE MEGLUMINE

SOLUTION;URETERAL

UROVIST CYSTO PEDIATRIC

BAYER HLTHCARE
SOLUTION;URETHRAL

HYPAQUE-CYSTO

GE HEALTHCARE

30%

A087731 001 Sep 23, 1982

30%

N016403 003

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE;INJECTION

ANGIOVIST 292

BAYER HLTHCARE

52%;8%

ANGIOVIST 370

BAYER HLTHCARE

66%;10%

DIATRIZOATE-60

INTL MEDICATION

52%;8%

HYPAQUE-76

GE HEALTHCARE

66%;10%

HYPAQUE-M,75%

GE HEALTHCARE

50%;25%

HYPAQUE-M,90%

GE HEALTHCARE

60%;30%

MD-60

MALLINCKRODT

52%;8%

MD-76

MALLINCKRODT

66%;10%

RENOCAL-76

BRACCO

66%;10%

RENOGRAFIN-60

BRACCO

52%;8%

RENOVIST

BRACCO

34.3%;35%

RENOVIST II

BRACCO

28.5%;29.1%

SOLUTION;ORAL, RECTAL

GASTROVIST

BAYER HLTHCARE

66%;10%

DIATRIZOATE SODIUM

FOR SOLUTION;ORAL, RECTAL

HYPAQUE

GE HEALTHCARE

INJECTABLE;INJECTION

HYPAQUE

GE HEALTHCARE

MD-50

MALLINCKRODT

UROVIST SODIUM 300

BAYER HLTHCARE

SOLUTION;ORAL, RECTAL

HYPAQUE

GE HEALTHCARE

SOLUTION;URETERAL

HYPAQUE SODIUM 20%

GE HEALTHCARE

6-109(of 347)

A087724 001 Sep 23, 1982

A087723 001 Sep 23, 1982

A088166 001 Jun 17, 1983

A086505 001

N010220 003

N010220 002

A087074 001

A087073 001

A089347 001 Jun 01, 1988

N010040 006

N010040 020

N010040 019

A087728 001 Sep 23, 1982

100%

N011386 001

25%

50%

N009561 003

N009561 001

50%

A087075 001

50%

A087725 001 Sep 23, 1982

40%

N011386 003

20%

N009561 002

DIAZEPAM

CAPSULE, EXTENDED RELEASE;ORAL

VALRELEASE

ROCHE

15MG

GEL;RECTAL

DIASTAT

VALEANT PHARMS NORTH
5MG/ML (5MG/ML) **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

10MG/2ML (5MG/ML)

15MG/3ML (5MG/ML)

20MG/4ML (5MG/ML)

INJECTABLE;INJECTION

DIAZEPAM

ABRAXIS PHARM

5MG/ML

HIKMA MAPLE

5MG/ML

N018179 001

N020648 002 Jul 29, 1997

N020648 003 Jul 29, 1997

N020648 004 Jul 29, 1997

N020648 005 Jul 29, 1997

A070662 001 Jun 25, 1986

A070311 001 Dec 16, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-110(of 347)

DISCONTINUED DRUG PRODUCT LIST

DIAZEPAM

INJECTABLE;INJECTION

DIAZEPAM

HOSPIRA

MARSAM PHARMS LLC

PARENTA PHARMS

US ARMY

WARNER CHILCOTT

WATSON LABS

WATSON LABS INC

DIZAC

PHARMACIA AND UPJOHN

VALIUM

ROCHE

TABLET;ORAL

DIAZEPAM

ACTAVIS ELIZABETH

DAVA PHARMS INC

DURAMED PHARMS BARR

FERNDALE LABS

HALSEY

IVAX SUB TEVA PHARMS

MARTEC USA LLC

PAR PHARM

PIONEER PHARMS

ROXANE

SANDOZ

TEVA PHARMS

WARNER CHILCOTT

WATSON LABS

Q-PAM

QUANTUM PHARMICS

5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML

A070312
A070313
A071308
A071309
A071310
A071584
A072371
A076815
N020124
A071613
A071614
A070296
A070911
A070912
A070930
A072370
A072397

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Dec
Dec
Jul
Jul
Jul
Oct
Jan
Apr
Dec
Oct
Oct
Feb
Aug
Aug
Dec
Jan
Jan

16,
16,
17,
17,
17,
13,
29,
15,
05,
22,
22,
12,
28,
28,
01,
29,
29,

1985
1985
1987
1987
1987
1987
1993
2004
1990
1987
1987
1986
1986
1986
1986
1993
1993

5MG/ML

N019287 001 Jun 18, 1993

5MG/ML

N016087 001

2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
5MG
2MG
5MG
10MG
2MG
5MG
10MG

A070781
A070706
A070707
A070226
A070227
A070228
A070894
A070895
A070896
A070903
A070904
A070905
A070987
A070996
A070956
A070360
A070361
A070362
A072402
A070462
A070463
A070464
A070787
A070788
A070776
A070356
A070357
A070358
A070302
A070303
A070304
A070153
A070209
A070210
A070222
A070456
A070457
A070458

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Mar
Mar
Mar
Sep
Sep
Sep
Aug
Aug
Aug
Apr
Apr
Apr
Aug
Aug
Aug
Sep
Sep
Sep
Apr
Feb
Feb
Feb
Aug
Aug
Aug
Jun
Jun
Jun
Dec
Dec
Dec
Nov
Sep
Sep
Sep
Nov
Nov
Nov

19,
19,
19,
26,
26,
26,
27,
27,
27,
01,
01,
01,
15,
15,
15,
04,
04,
04,
25,
25,
25,
25,
02,
02,
02,
17,
17,
17,
20,
20,
20,
01,
04,
04,
04,
01,
01,
01,

1986
1986
1986
1985
1985
1985
1986
1986
1986
1987
1987
1987
1986
1986
1986
1985
1985
1985
1989
1986
1986
1986
1988
1988
1988
1986
1986
1986
1985
1985
1985
1985
1985
1985
1985
1985
1985
1985

2MG
2MG
5MG
5MG
10MG
10MG

A070423
A072431
A070424
A072432
A070425
A072433

001
001
001
001
001
001

Dec
Apr
Dec
Apr
Dec
Apr

12,
29,
12,
29,
12,
29,

1985
1988
1985
1988
1985
1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-111(of 347)

DISCONTINUED DRUG PRODUCT LIST

DIAZOXIDE

CAPSULE;ORAL

PROGLYCEM

TEVA BRANDED PHARM
INJECTABLE;INJECTION

DIAZOXIDE

ABRAXIS PHARM
HYPERSTAT

SCHERING
DIBUCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

HEAVY SOLUTION NUPERCAINE

NOVARTIS
DICHLORPHENAMIDE

TABLET;ORAL

DARANIDE

TARO

DICLOFENAC POTASSIUM

TABLET;ORAL

CATAFLAM

NOVARTIS

DICLOFENAC POTASSIUM

MUTUAL PHARM
SANDOZ
WATSON LABS

50MG
100MG

N017425 001

N017425 002

15MG/ML

A071519 001 Aug 26, 1987

15MG/ML

N016996 001

2.5MG/ML

N006203 001

50MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N011366 001

25MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N020142 001 Nov 24, 1993

50MG
50MG
50MG

A075470 001 Feb 21, 2002

A075582 001 Feb 23, 2001

A075152 001 Nov 27, 1998

DICLOFENAC SODIUM

SOLUTION/DROPS;OPHTHALMIC

DICLOFENAC SODIUM

APOTEX INC
0.1%
FALCON PHARMS
0.1%
TABLET, DELAYED RELEASE;ORAL

DICLOFENAC SODIUM

NOSTRUM LABS
50MG
75MG
PLIVA
50MG
75MG
ROXANE
25MG
50MG
75MG
TEVA
50MG
75MG
TEVA PHARMS
25MG
50MG
75MG
VOLTAREN

NOVARTIS
25MG
50MG
75MG
DICLOXACILLIN SODIUM

CAPSULE;ORAL

DYCILL

GLAXOSMITHKLINE

PATHOCIL

WYETH AYERST
FOR SUSPENSION;ORAL

DICLOXACILLIN SODIUM

APOTHECON
DYNAPEN

APOTHECON

EQ
EQ
EQ
EQ

250MG
250MG
500MG
500MG

A077600 001 Nov 13, 2008

N020809 001 May 04, 1998

A074986
A074986
A074432
A074432
A074391
A074391
A074391
A074723
A074390
A074459
A074459
A074459

001
002
002
003
001
002
003
001
001
001
002
003

Feb
Feb
Jul
Jul
Jun
Jun
Jun
Mar
Aug
Jun
Jun
Jun

26,
26,
29,
29,
29,
29,
29,
30,
15,
25,
25,
25,

1999

1999

1999

1999

1995

1995

1995

1999

1996

1997

1997

1997

N019201 001 Jul 28, 1988

N019201 002 Jul 28, 1988

N019201 003 Jul 28, 1988

BASE
BASE
BASE
BASE

A060254
A062238
A060254
A062238

002

001

003

002

EQ 250MG BASE
EQ 500MG BASE

N050011 002

N050011 003 Mar 28, 1983

EQ 62.5MG BASE/5ML

A061455 001

EQ 62.5MG BASE/5ML

N050337 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-112(of 347)

DISCONTINUED DRUG PRODUCT LIST

DICLOXACILLIN SODIUM

FOR SUSPENSION;ORAL

PATHOCIL

WYETH AYERST

DICUMAROL

CAPSULE;ORAL

DICUMAROL

LILLY

TABLET;ORAL

DICUMAROL

ABBVIE

DICYCLOMINE HYDROCHLORIDE

CAPSULE;ORAL

DICYCLOMINE HYDROCHLORIDE

HIKMA PHARMS LLC

MUTUAL PHARM

PIONEER PHARMS

WATSON LABS

INJECTABLE;INJECTION

DICYCLOMINE HYDROCHLORIDE

WATSON LABS

SYRUP;ORAL

DICYCLOMINE HYDROCHLORIDE

ALPHARMA US PHARMS

TABLET;ORAL

DICYCLOMINE HYDROCHLORIDE

HIKMA PHARMS LLC

MUTUAL PHARM

PIONEER PHARMS

WATSON LABS

DIDANOSINE

FOR SOLUTION;ORAL

VIDEX

BRISTOL MYERS SQUIBB

TABLET, CHEWABLE;ORAL

VIDEX

BRISTOL MYERS SQUIBB

DIENESTROL

CREAM;VAGINAL

DIENESTROL

ORTHO MCNEIL PHARM

DV

SANOFI AVENTIS US

ESTRAGUARD

SOLVAY

SUPPOSITORY;VAGINAL

DV

SANOFI AVENTIS US

DIETHYLCARBAMAZINE CITRATE

TABLET;ORAL

HETRAZAN

LEDERLE

EQ 62.5MG BASE/5ML

N050092 001

25MG

50MG

N005509 003

N005509 001

25MG

50MG

100MG

N005545 003

N005545 004

N005545 005

10MG

10MG

10MG

10MG

A040204
A084505
A089361
A083179

10MG/ML

A080614 001 Feb 11, 1986

10MG/5ML

A084479 001

20MG

20MG

20MG

20MG

A040161
A084600
A088585
A084361

001
001
001
001

Oct
Jul
Aug
Feb

01,
29,
20,
06,

1996

1985

1986

1986

100MG/PACKET

167MG/PACKET

250MG/PACKET

375MG/PACKET

N020155
N020155
N020155
N020155

003
004
005
006

Oct
Oct
Oct
Oct

09,
09,
09,
09,

1991

1991

1991

1991

25MG

50MG

100MG

150MG

200MG

N020154
N020154
N020154
N020154
N020154

002
003
004
005
006

Oct
Oct
Oct
Oct
Oct

09,
09,
09,
09,
28,

1991

1991

1991

1991

1999

0.01%

N006110 005

0.01%

A083518 001

0.01%

A084436 001

0.7MG

A083517 001

50MG

N006459 001

DIETHYLPROPION HYDROCHLORIDE

TABLET;ORAL

DIETHYLPROPION HYDROCHLORIDE
SANDOZ
25MG
TEVA
25MG
TG UNITED LABS
25MG
25MG

A085916
A088642
A088267
A088268

001
001
001
001

Feb
Oct
Jan
Feb

28,
21,
10,
12,

1997

1986

1989

1986

001
001 Sep 20, 1984
001 Aug 25, 1983
001 Aug 25, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-113(of 347)

DISCONTINUED DRUG PRODUCT LIST

DIETHYLPROPION HYDROCHLORIDE

TABLET;ORAL

DIETHYLPROPION HYDROCHLORIDE

UCB INC

25MG

WATSON LABS

25MG

TENUATE

SANOFI AVENTIS US

25MG

TEPANIL

3M

25MG

TABLET, EXTENDED RELEASE;ORAL

TENUATE

SANOFI AVENTIS US

75MG

TEPANIL TEN-TAB

3M

75MG

DIETHYLSTILBESTROL

INJECTABLE;INJECTION

STILBESTROL

BRISTOL MYERS SQUIBB

SUPPOSITORY;VAGINAL

DIETHYLSTILBESTROL

LILLY

STILBESTROL

BRISTOL MYERS SQUIBB

TABLET;ORAL

DIETHYLSTILBESTROL

LILLY

STILBESTROL

TABLICAPS

STILBETIN

BRISTOL MYERS SQUIBB

A085544 001

A085741 001

N017668 001

N011673 001

N017669 001

N017956 001

0.2MG/ML

0.5MG/ML

1MG/ML

5MG/ML

N004056
N004056
N004056
N004056

0.1MG

0.5MG

N004040 001

N004040 002

0.1MG

0.5MG

N004056 001

N004056 002

0.1MG

0.5MG

1MG

5MG

N004041
N004041
N004041
N004041

0.5MG

1MG

5MG

A083004 001

A083002 001

A083006 001

0.1MG

0.25MG

0.5MG

1MG

5MG

N004056
N004056
N004056
N004056
N004056

007

017

008

009

010

N004039
N004039
N004039
N004039
N004039

002

005

003

004

006

TABLET, DELAYED RELEASE;ORAL

DIETHYLSTILBESTROL

LILLY

0.1MG

0.25MG

0.5MG

1MG

5MG

STILBESTROL

TABLICAPS

0.5MG

1MG

5MG

STILBETIN

BRISTOL MYERS SQUIBB
0.1MG

0.5MG

1MG

5MG

DIETHYLSTILBESTROL DIPHOSPHATE

INJECTABLE;INJECTION

STILPHOSTROL

BAYER PHARMS

250MG/5ML

TABLET;ORAL

STILPHOSTROL

BAYER PHARMS

50MG

003

004

005

006

002

003

004

005

A083003 001

A083005 001

A083007 001

N004056
N004056
N004056
N004056

011

012

013

014

N010010 001

N010010 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-114(of 347)

DISCONTINUED DRUG PRODUCT LIST

DIFLORASONE DIACETATE

CREAM;TOPICAL

DIFLORASONE DIACETATE

FOUGERA PHARMS
FLORONE

PHARMACIA AND UPJOHN
FLORONE E

PHARMACIA AND UPJOHN
PSORCON

TARO PHARMS NORTH
OINTMENT;TOPICAL

PSORCON

PHARMACIA AND UPJOHN
PSORCON E

PHARMACIA AND UPJOHN
DIFLUNISAL

TABLET;ORAL

DIFLUNISAL

PUREPAC PHARM
ROXANE
SANDOZ
TEVA
WATSON LABS
DOLOBID

MERCK

DIGITOXIN

INJECTABLE;INJECTION

CRYSTODIGIN

LILLY
DIGOXIN

CAPSULE;ORAL

LANOXICAPS

GLAXOSMITHKLINE LLC

INJECTABLE;INJECTION

DIGOXIN

ABRAXIS PHARM
HOSPIRA
WYETH AYERST
DIGOXIN PEDIATRIC

HOSPIRA
TABLET;ORAL

LANOXIN

CONCORDIA PHARMS INC

0.05%

A075187 001 Mar 30, 1998

0.05%

N017741 001

0.05%

N019259 001 Aug 28, 1985

0.05%

N020205 001 Nov 20, 1992

0.05%

N019260 001 Aug 28, 1985

0.05%

N017994 001

250MG
500MG
250MG
500MG
500MG
250MG
250MG
500MG

A074285
A074285
A073562
A073563
A074604
A073679
A074400
A074400

250MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

500MG

N018445 001 Apr 19, 1982

N018445 002 Apr 19, 1982

0.2MG/ML

A084100 005

0.05MG
0.1MG
0.15MG
0.2MG

N018118
N018118
N018118
N018118

002
003
004
001

0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML

A083217
A040093
A040206
A084386

001

001 May 16, 1996

001 Aug 28, 1998

001

0.1MG/ML

A040092 001 Apr 25, 1996

0.375MG
0.5MG

N020405 005 Sep 30, 1997

N020405 006 Sep 30, 1997

DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

EMBOLEX

NOVARTIS
0.5MG/0.5ML;2,500
UNITS/0.5ML;5.33MG/0.5ML

0.5MG/0.7ML;5,000
UNITS/0.7ML;7.46MG/0.7ML

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CARDIZEM SR

BIOVAIL
60MG
90MG
120MG
180MG

001
002
001
001
001
001
001
002

May
May
Nov
Nov
Jun
Jul
Jul
Jul

Jul
Jul
Sep
Jul

07,
07,
27,
27,
10,
31,
17,
17,

26,
26,
24,
26,

1996

1996

1992

1992

1996

1992

1997

1997

1982

1982

1984

1982

N018885 001 Nov 30, 1984

N018885 002 Nov 30, 1984

N019471
N019471
N019471
N019471

001
002
003
004

Jan
Jan
Jan
Jan

23,
23,
23,
23,

1989

1989

1989

1989

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-115(of 347)

DISCONTINUED DRUG PRODUCT LIST

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

DILACOR XR

ACTAVIS LABS UT INC

120MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

180MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

240MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

DILT-CD

APOTEX

120MG

180MG

240MG

300MG

DILTIAZEM HYDROCHLORIDE

BIOVAIL

60MG

90MG

120MG

120MG

180MG

240MG

300MG

360MG

420MG

NESHER PHARMS

120MG

180MG

240MG

300MG

360MG

420MG

TEVA

60MG

90MG

120MG

INJECTABLE;INJECTION

CARDIZEM

BIOVAIL

100MG/VIAL

BIOVAIL LABS INTL

5MG/ML

25MG/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

DILTIAZEM HYDROCHLORIDE

HOSPIRA

5MG/ML

5MG/ML

MYLAN LABS LTD

5MG/ML

TEVA PHARMS USA

5MG/ML

TABLET;ORAL

DILTIAZEM HYDROCHLORIDE

APOTHECON

30MG

60MG

90MG

120MG

DAVA PHARMS INC

30MG

60MG

90MG

120MG

IVAX SUB TEVA PHARMS
30MG

60MG

90MG

120MG

TEVA

30MG

60MG

TEVA PHARMS

30MG

60MG

90MG

120MG

N020092 001
May 29, 1992

N020092 002
May 29, 1992

N020092 003
May 29, 1992

A076151
A076151
A076151
A076151

001

002

003

004

May
May
May
May

20,
20,
20,
20,

2004

2004

2004

2004

A074845
A074845
A074845
N020939
N020939
N020939
N020939
N020939
N020939
A076563
A076563
A076563
A076563
A076563
A076563
A074079
A074079
A074079

001

002

003

001

002

003

004

005

006

002

003

004

005

006

001

001

002

003

Sep
Sep
Sep
Jan
Jan
Jan
Jan
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Nov
Nov
Nov

15,
15,
15,
28,
28,
28,
28,
14,
14,
12,
12,
12,
12,
12,
12,
30,
30,
30,

1999

1999

1999

2000

2000

2000

2000

2001

2001

2006

2006

2006

2006

2006

2006

1993

1993

1993

N020792 001
Sep 05, 1997

N020027 001
Oct 24, 1991

N020027 003
Aug 18, 1995

A075004
A075106
A075375
A074894

001

001

001

001

Feb
Apr
Sep
Aug

16,
29,
30,
26,

2000

1999

1999

1997

A074051
A074051
A074051
A074051
A074093
A074093
A074093
A074093
A074168
A074168
A074168
A074168
A074084
A074084
A074067
A074067
A074067
A074067

001

002

003

004

001

002

003

004

001

002

003

004

001

002

001

002

003

004

Mar
Mar
Mar
Mar
Nov
Nov
Nov
Nov
Mar
Mar
Mar
Mar
Feb
Feb
Nov
Nov
Nov
Nov

31,
31,
31,
31,
05,
05,
05,
05,
03,
03,
03,
03,
25,
25,
05,
05,
05,
05,

1993

1993

1993

1993

1992

1992

1992

1992

1995

1995

1995

1995

1994

1994

1992

1992

1992

1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-116(of 347)

DISCONTINUED DRUG PRODUCT LIST

DILTIAZEM MALATE

TABLET, EXTENDED RELEASE;ORAL

TIAMATE

MERCK
EQ 120MG HCL

EQ 180MG HCL

EQ 240MG HCL

N020506 001 Oct 04, 1996

N020506 002 Oct 04, 1996

N020506 003 Oct 04, 1996

DILTIAZEM MALATE; ENALAPRIL MALEATE

TABLET, EXTENDED RELEASE;ORAL

TECZEM

BIOVAIL

EQ 180MG HCL;5MG

N020507 001 Oct 04, 1996

DIMENHYDRINATE

INJECTABLE;INJECTION

DIMENHYDRINATE

BAXTER HLTHCARE

WATSON LABS

WYETH AYERST

LIQUID;ORAL

DIMENHYDRINATE

ALRA

TABLET;ORAL

DIMENHYDRINATE

HEATHER

NEXGEN PHARMA INC

WATSON LABS

50MG/ML

50MG/ML

50MG/ML

50MG/ML

A084767
A080615
A083531
A084316

001

001

001

001

12.5MG/4ML

A080715 001

50MG

50MG

50MG

A080841 001

A085985 001

A085166 001

DIMYRISTOYL LECITHIN; PERFLEXANE

INJECTABLE;INTRAVENOUS

IMAGENT

IMCOR PHARMS CO

0.92MG/VIAL;0.092MG/VIAL

N021191 001 May 31, 2002

DINOPROST TROMETHAMINE

INJECTABLE;INJECTION

PROSTIN F2 ALPHA

PHARMACIA AND UPJOHN

EQ 5MG BASE/ML

N017434 001

DIPHEMANIL METHYLSULFATE

TABLET;ORAL

PRANTAL

SCHERING

100MG

N008114 004

DIPHENHYDRAMINE HYDROCHLORIDE

CAPSULE;ORAL

BENADRYL

MCNEIL CONS

25MG

50MG

DIPHENHYDRAMINE HYDROCHLORIDE

ALRA
25MG
50MG
ANABOLIC
50MG
ELKINS SINN
25MG
50MG
HALSEY
50MG
HEATHER
25MG
50MG
HIKMA PHARMS LLC
50MG
IMPAX LABS
25MG
50MG
IVAX SUB TEVA PHARMS
25MG
50MG
LANNETT
25MG
50MG
LEDERLE
25MG
50MG
LNK
25MG
50MG
MK LABS
25MG
50MG
MUTUAL PHARM
25MG
25MG
50MG
NEWTRON PHARMS
25MG
50MG

N005845 007

N005845 001

A080519
A080519
A083275
A085701
A085701
A087914
A084524
A083953
A083567
A080807
A080807
A080762
A080762
A080868
A080868
A086874
A086875
A087977
A087978
A083087
A083087
A084506
A089488
A089489
A086543
A086544

004

003

001

001

002

001
001

001

001

001

002

001

002

001

002

001

001

001
001
001

002

001

001
001
001

001

Jun 04, 1984

Jan 27, 1983

Jan 27, 1983

Jan 02, 1987

Jan 02, 1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-117(of 347)

DISCONTINUED DRUG PRODUCT LIST

DIPHENHYDRAMINE HYDROCHLORIDE

CAPSULE;ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

NEXGEN PHARMA INC

25MG

PERRIGO

25MG

50MG

PIONEER PHARMS

25MG

50MG

PUREPAC PHARM

25MG

50MG

PVT FORM

25MG

50MG

ROXANE

50MG

SANDOZ

25MG

25MG

50MG

50MG

SUPERPHARM

25MG

50MG

TEVA

25MG

50MG

VALEANT PHARM INTL

25MG

50MG

VANGARD

25MG

50MG

WATSON LABS

25MG

25MG

25MG

50MG

50MG

50MG

WHITEWORTH TOWN PLSN
25MG

50MG

ELIXIR;ORAL

BELIX

HALSEY

12.5MG/5ML

BENADRYL

MCNEIL CONS

12.5MG/5ML

DIBENIL

CENCI

12.5MG/5ML

DIPHEN

USL PHARMA

12.5MG/5ML

DIPHENHYDRAMINE HYDROCHLORIDE

BUNDY

12.5MG/5ML

CENCI

12.5MG/5ML

KV PHARM

12.5MG/5ML

LANNETT

12.5MG/5ML

LEDERLE

12.5MG/5ML

MK LABS

12.5MG/5ML

NASKA

12.5MG/5ML

PERRIGO

12.5MG/5ML

PUREPAC PHARM

12.5MG/5ML

PVT FORM

12.5MG/5ML

ROXANE

12.5MG/5ML

HYDRAMINE

ALPHARMA US PHARMS

12.5MG/5ML

INJECTABLE;INJECTION

BENADRYL

MCNEIL CONS

10MG/ML

50MG/ML

BENADRYL PRESERVATIVE FREE

MCNEIL CONS

50MG/ML

DIPHENHYDRAMINE HYDROCHLORIDE

BEL MAR
10MG/ML

HIKMA MAPLE
50MG/ML

LYPHOMED
10MG/ML

WATSON LABS
10MG/ML

WATSON LABS INC

10MG/ML

50MG/ML

WYETH AYERST
50MG/ML

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

ABRAXIS PHARM
50MG/ML

A083634
A083061
A083061
A089101
A088880
A085156
A085150
A083027
A083027
A080635
A080832
A080845
A080832
A080845
A089040
A089041
A085874
A085874
A080596
A080592
A088034
A087630
A080728
A083797
A085138
A080727
A083797
A085083
A083441
A080800

001

001

002

001
001
001

001

001

002

001

001

002

002

001

001
001
001

002

001

001

001
001

001

001

001

001

002

001

001

001

Dec 20, 1985

Dec 20, 1985

May 15, 1985

May 15, 1985

Oct 27, 1982

A086586 001 Oct 03, 1983

N005845 004

A088304 001 Dec 16, 1983

A084640 001

A083674
A087941
A085621
A080939
A086937
A083088
A088680
A083063
A083237
A085287
A080643

001

001 Dec 17, 1982

001

002

001

002

001 May 31, 1985

001

001 Jan 25, 1982

001

001

A080763 002

N006146 001

N006146 002

N009486 001

A080822
A083183
A087066
A083533
A080873
A080873
A080577

001

001

001

001

001

002

001

A080586 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-118(of 347)

DISCONTINUED DRUG PRODUCT LIST

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

INTL MEDICATION
50MG/ML
WATSON LABS INC
50MG/ML
SYRUP;ORAL
ANTITUSSIVE
PERRIGO
12.5MG/5ML
BELDIN
HALSEY
12.5MG/5ML
BENYLIN
PARKE DAVIS
12.5MG/5ML
DIPHEN
MORTON GROVE
12.5MG/5ML
DIPHENHYDRAMINE HYDROCHLORIDE
ALPHARMA US PHARMS
12.5MG/5ML
CUMBERLAND SWAN
12.5MG/5ML
HI TECH PHARMA
12.5MG/5ML
HYDRAMINE
ALPHARMA US PHARMS
12.5MG/5ML
SILPHEN
SILARX
12.5MG/5ML
VICKS FORMULA 44
WARNER CHILCOTT
12.5MG/5ML

A070524 001 Jan 14, 1987

DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL
BENYLIN
PARKE DAVIS
12.5MG/5ML;30MG/5ML

N019014 001 Jun 11, 1985

DIPHENIDOL HYDROCHLORIDE
TABLET;ORAL
VONTROL
GLAXOSMITHKLINE

N016033 001

EQ 25MG BASE

DIPHENYLPYRALINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
HISPRIL
GLAXOSMITHKLINE
5MG
DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AKPRO
AKORN
DIPIVEFRIN HYDROCHLORIDE
BAUSCH AND LOMB
FALCON PHARMS
PROPINE
ALLERGAN
DIPYRIDAMOLE
INJECTABLE;INJECTION
DIPYRIDAMOLE
HOSPIRA
MYLAN LABS LTD
TEVA PHARMS USA
IV PERSANTINE
BOEHRINGER INGELHEIM
TABLET;ORAL
DIPYRIDAMOLE
GLENMARK GENERICS

PROSAM LABS

PUREPAC PHARM
SANDOZ

WATSON LABS

A084094 001
A080873 003

A071292 001 Apr 10, 1987

A089179 001 Jun 05, 1986
N006514 004
A070118 001 Oct 01, 1985
A070497 001 Apr 25, 1989
A073611 001 Aug 20, 1992
A072416 001 Sep 28, 1990
A070205 001 Jan 28, 1986
A072646 001 Feb 27, 1992

N011945 001

0.1%

A074382 001 Sep 29, 1995

0.1%
0.1%

A074188 001 May 19, 1995

A073636 001 Jun 30, 1994

0.1%

N018239 001

5MG/ML
5MG/ML
5MG/ML

A074601 001 Dec 19, 1997

A075769 001 Nov 27, 2002
A074952 001 Nov 26, 1997

5MG/ML

N019817 001 Dec 13, 1990

25MG
50MG
75MG
25MG
50MG
75MG
50MG
75MG
25MG
50MG
75MG
50MG

A088999
A089000
A089001
A040542
A040542
A040542
A089426
A089427
A086944
A087562
A087561
A087160

001
001
001
001
002
003
001
001
002
001
001
001

Feb
Feb
Feb
Apr
Apr
Apr
Jul
Jul
Apr
Feb
Feb
Jun

05,
05,
05,
21,
21,
21,
12,
12,
16,
25,
25,
07,

1991
1991
1991
2006
2006
2006
1990
1990
1991
1992
1992
1996

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-119(of 347)

DISCONTINUED DRUG PRODUCT LIST

DIRITHROMYCIN

TABLET, DELAYED RELEASE;ORAL

DYNABAC

LILLY RES LABS
250MG
DISOPYRAMIDE PHOSPHATE

CAPSULE;ORAL

DISOPYRAMIDE PHOSPHATE

INTERPHARM

EQ
EQ
IVAX SUB TEVA PHARMS
EQ
EQ
MUTUAL PHARM
EQ
EQ
MYLAN
EQ
EQ
SANDOZ
EQ
EQ
SUPERPHARM
EQ
EQ
WATSON LABS
EQ
EQ
CAPSULE, EXTENDED RELEASE;ORAL

DISOPYRAMIDE PHOSPHATE

NESHER PHARMS
EQ

DISULFIRAM

TABLET;ORAL

ANTABUSE

TEVA WOMENS
DISULFIRAM

PAR PHARM
WATSON LABS

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

150MG BASE

A071190
A071191
A070186
A070187
A070351
A070352
A070138
A070139
A070470
A070471
A070940
A070941
A070240
A070241

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jan
Jan
Nov
Nov
Dec
Dec
Jun
Jun
Dec
Dec
Feb
Feb
Feb
Feb

15,
15,
18,
18,
17,
17,
14,
14,
10,
10,
09,
09,
02,
02,

1987

1987

1985

1985

1985

1985

1985

1985

1985

1985

1987

1987

1986

1986

A071200 001 Dec 15, 1987

250MG
500MG

N007883 003

N007883 002

250MG
500MG
250MG
250MG
500MG
500MG

A088792
A088793
A086889
A087973
A086890
A087974

DIVALPROEX SODIUM

TABLET, DELAYED RELEASE;ORAL

DEPAKOTE CP

ABBOTT
EQ
EQ
DIVALPROEX SODIUM

MYLAN
EQ
EQ
EQ
TABLET, EXTENDED RELEASE;ORAL

DIVALPROEX SODIUM

G AND W LABS INC
EQ
DOBUTAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DOBUTAMINE HYDROCHLORIDE

BAXTER HLTHCARE
HOSPIRA
IGI LABS INC
LUITPOLD
TEVA PARENTERAL
WATSON LABS
WATSON LABS INC

100MG
150MG
100MG
150MG
100MG
150MG
100MG
150MG
100MG
150MG
100MG
150MG
100MG
150MG

N050678 001 Jun 19, 1995

001
001
001

001
001

001

Aug 14, 1984

Aug 14, 1984

Aug 05, 1983

Aug 05, 1983

250MG BASE
500MG BASE

N019794 001 Jul 11, 1990

N019794 002 Jul 11, 1990

125MG VALPROIC ACID

250MG VALPROIC ACID
500MG VALPROIC ACID

A077254 001 Jul 29, 2008

A077254 002 Jul 29, 2008

A077254 003 Jul 29, 2008

500MG VALPROIC ACID

A078700 001 Aug 03, 2009

EQ 12.5MG BASE/ML
EQ 1.25GM BASE/100ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

HOSPIRA
EQ 50MG BASE/100ML
EQ 100MG BASE/100ML
EQ 200MG BASE/100ML
DOBUTREX

LILLY
EQ 12.5MG BASE/ML

A074381
A074634
A074098
A074545
A074206
A074114
A074279
A074995

001
001
001
001
001
001
001
001

Sep
Sep
Feb
Jun
Oct
Nov
Feb
Mar

26,
27,
21,
25,
19,
30,
18,
31,

1996

1996

1995

1998

1993

1993

1998

1998

N020269 001 Oct 19, 1993

N020269 002 Oct 19, 1993

N020269 003 Oct 19, 1993

N017820 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-120(of 347)

DISCONTINUED DRUG PRODUCT LIST

DOCETAXEL

INJECTABLE;INJECTION

DOCETAXEL

APOTEX INC
TAXOTERE

SANOFI AVENTIS US

DONEPEZIL HYDROCHLORIDE

SOLUTION;ORAL

ARICEPT

EISAI INC
TABLET;ORAL

DONEPEZIL HYDROCHLORIDE

ACCORD HLTHCARE

20MG/0.5ML (40MG/ML)
80MG/2ML (40MG/ML)

N022312 001 Jan 11, 2012

N022312 002 Jan 11, 2012

40MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N020449 001 May 14, 1996

5MG/5ML

N021719 001 Oct 18, 2004

5MG
10MG
TABLET, ORALLY DISINTEGRATING;ORAL

DONEPEZIL HYDROCHLORIDE

MUTUAL PHARM
5MG
10MG

DOPAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DOPAMINE HYDROCHLORIDE

ABBOTT

40MG/ML
80MG/ML
ABRAXIS PHARM
40MG/ML
40MG/ML
80MG/ML
80MG/ML
160MG/ML
BAXTER HLTHCARE
40MG/ML
80MG/ML
HOSPIRA
40MG/ML
IGI LABS INC
40MG/ML
40MG/ML
80MG/ML
80MG/ML
80MG/ML
160MG/ML
160MG/ML
160MG/ML
INTL MEDICATION
40MG/ML
LYPHOMED
40MG/ML
SMITH AND NEPHEW
40MG/ML
40MG/ML
80MG/ML
TEVA PARENTERAL
40MG/ML
80MG/ML
WARNER CHILCOTT
40MG/ML
40MG/ML
80MG/ML
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%

HOSPIRA
1.6MG/ML
INTROPIN

HOSPIRA
40MG/ML
80MG/ML
160MG/ML

DORZOLAMIDE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE

APOTEX INC

EQ 2% BASE

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

APOTEX INC
EQ 2% BASE;EQ 0.5% BASE

A201335 001 Aug 29, 2011

A201335 002 Aug 29, 2011

A077975 002 Dec 11, 2009

A077975 001 Dec 11, 2009

A070656
A070657
A070012
A070058
A070013
A070059
A070364
N018398
N018398
A074403
A070087
N018656
A070089
A070090
A070091
A070092
A070093
A070094
N018014
N018549
A070011
A070046
A070047
A072999
A073000
A070558
N018138
A070559

001
001
001
001
001
001
001
001

002
001
001
001
001
001
001
001
001
001
001

001
001
001
001
001
001
001
001

001

Jan
Jan
Jun
Mar
Jun
Mar
Dec

24,
24,
12,
20,
12,
20,
04,

1989

1989

1985

1985

1985

1985

1985

Mar
May
Oct
Jun
Oct
Oct
Oct
Oct
Oct
Oct

22,
23,
23,
28,
23,
23,
23,
23,
23,
23,

1982

1996

1985

1983

1985

1985

1985

1985

1985

1985

Mar
Aug
Aug
Aug
Oct
Oct
Sep

11,
29,
29,
29,
23,
23,
20,

1983

1985

1985

1985

1991

1991

1985

Sep 20, 1985

N020542 001 Aug 30, 1995

N017395 001

N017395 002

N017395 003

A078395 001 Oct 28, 2008

A078201 001 Oct 28, 2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-121(of 347)

DISCONTINUED DRUG PRODUCT LIST

DOXACURIUM CHLORIDE

INJECTABLE;INJECTION

NUROMAX

ABBVIE

EQ 1MG BASE/ML

N019946 001 Mar 07, 1991

DOXAPRAM HYDROCHLORIDE

INJECTABLE;INJECTION

DOXAPRAM HYDROCHLORIDE

WATSON LABS

20MG/ML

A073529 001 Jan 30, 1992

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
1MG
2MG
2MG
4MG
4MG
8MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG

A075574
A075574
A075574
A075574
A075466
A075466
A075466
A075466
A075453
A075453
A075453
A075453
A075609
A075609
A075609
A075609
A075432
A075646
A075432
A075646
A075432
A075646
A075432
A075646
A075353
A075353
A075353
A075353
A075426
A075426
A075426
A075426

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004
001
002
003
004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
Oct
Oct
Oct
Oct

18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
12,
12,
12,
12,
18,
18,
18,
18,

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2001

2001

2001

2001

2000

2000

2000

2000

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

10MG BASE

25MG BASE

50MG BASE

75MG BASE

100MG BASE

150MG BASE

25MG BASE

50MG BASE

75MG BASE

100MG BASE

10MG BASE

25MG BASE

50MG BASE

75MG BASE

100MG BASE

150MG BASE

10MG BASE

25MG BASE

50MG BASE

75MG BASE

100MG BASE

10MG BASE

25MG BASE

50MG BASE

75MG BASE

A071685
A071686
A071673
A071674
A071675
A071676
A071502
A071653
A071654
A071521
N016987
N016987
N016987
N016987
N016987
N016987
A071697
A071437
A071595
A071608
A071422
A073054
A072109
A073055
A072386

001
001
001
001
001
001
001
001
001
001
001

002

003

006

004

007
001
001
001
001
001
001
001
001
001

Jan
Jan
Jan
Jan
Jan
Jan
Feb
Feb
Feb
Feb

05,
05,
05,
05,
05,
05,
18,
18,
18,
18,

1988

1988

1988

1988

1988

1988

1988

1988

1988

1988

Apr
Nov
Nov
Nov
Nov
Nov
Dec
Dec
Dec
Sep

13,
09,
09,
09,
09,
09,
28,
28,
28,
08,

1987

1987

1987

1987

1987

1987

1990

1990

1990

1988

DOXAZOSIN MESYLATE

TABLET;ORAL

DOXAZOSIN MESYLATE

ACTAVIS ELIZABETH

GENPHARM

IVAX SUB TEVA PHARMS

NESHER PHARMS

SANDOZ

TEVA

WATSON LABS INC

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL

DOXEPIN HYDROCHLORIDE

DAVA PHARMS INC

MUTUAL PHARM

NEW RIVER

PAR PHARM

PUREPAC PHARM

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-122(of 347)

DISCONTINUED DRUG PRODUCT LIST

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL

DOXEPIN HYDROCHLORIDE

QUANTUM PHARMICS

SANDOZ

WATSON LABS

SINEQUAN

PFIZER

CONCENTRATE;ORAL

DOXEPIN HYDROCHLORIDE

PHARM ASSOC
SINEQUAN

PFIZER
DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

ADRIAMYCIN PFS

PHARMACIA AND UPJOHN
DOXORUBICIN HYDROCHLORIDE

PHARMACIA AND UPJOHN

RUBEX

BRISTOL MYERS SQUIBB

DOXYCYCLINE

CAPSULE;ORAL

DOXYCYCLINE

PAR PHARM
SANDOZ INC
WATSON LABS
FOR SUSPENSION;ORAL

DOXYCHEL

RACHELLE
TABLET;ORAL

DOXYCYCLINE

MUTUAL PHARM

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

100MG BASE
150MG BASE
10MG BASE
25MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE
10MG BASE
25MG BASE
50MG BASE
75MG BASE
100MG BASE
10MG BASE
10MG BASE
10MG BASE
25MG BASE
25MG BASE
25MG BASE
50MG BASE
50MG BASE
50MG BASE
75MG BASE
75MG BASE
100MG BASE
100MG BASE
150MG BASE

A072110
A072387
A070972
A070973
A070931
A070932
A072375
A072376
A071487
A070827
A070828
A070825
A071562
A070952
A071485
A072985
A070953
A071486
A072986
A070954
A071238
A072987
A071326
A071763
A070955
A071239
A071764

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

EQ
EQ
EQ
EQ
EQ
EQ

10MG BASE
25MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE

N016798
N016798
N016798
N016798
N016798
N016798

003

001

002

006

005

007

Sep
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
May
May
May
Mar
Mar
Apr
Mar
May
Apr
Mar
May
Apr
Mar
Apr
Feb
May
Apr
Feb

08,
08,
29,
29,
29,
29,
15,
15,
02,
15,
15,
15,
02,
04,
30,
29,
15,
30,
29,
15,
30,
29,
30,
09,
15,
30,
09,

1988

1988

1987

1987

1987

1987

1989

1989

1987

1986

1986

1986

1987

1987

1987

1991

1986

1987

1991

1986

1987

1991

1987

1988

1986

1987

1988

EQ 10MG BASE/ML

A075924 001 Jan 15, 2004

EQ 10MG BASE/ML

N017516 001

2MG/ML
200MG/100ML

A063165 001 Jan 30, 1991

A063165 002 Jan 30, 1991

10MG/VIAL
20MG/VIAL
50MG/VIAL
150MG/VIAL

N050467
N050467
N050467
N050467

10MG/VIAL
50MG/VIAL
100MG/VIAL

A062926 001 Apr 13, 1989

A062926 002 Apr 13, 1989

A062926 003 Apr 13, 1989

EQ
EQ
EQ
EQ
EQ

A065055
A065032
A065032
A065041
A065041

75MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE

001

003 May 20, 1985

002

004 Jul 22, 1987

004
001
002
001
002

Apr
Jun
Jun
Apr
Apr

18,
30,
30,
28,
28,

2005

2000

2000

2000

2000

EQ 25MG BASE/5ML

A061720 001

EQ 50MG BASE
EQ 75MG BASE

A065471 001 Apr 17, 2009

A065471 002 Apr 17, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-123(of 347)

DISCONTINUED DRUG PRODUCT LIST

DOXYCYCLINE

TABLET;ORAL

DOXYCYCLINE

SANDOZ INC

DOXYCYCLINE HYCLATE

CAPSULE;ORAL

DOXY-LEMMON

TEVA
DOXYCYCLINE HYCLATE

HALSEY
HEATHER
INTERPHARM
MUTUAL PHARM
PAR PHARM
PVT FORM
RANBAXY
SUPERPHARM
WARNER CHILCOTT
WATSON LABS

EQ
EQ
EQ
EQ

100MG BASE
50MG BASE
75MG BASE
100MG BASE

A065471
A065353
A065353
A065353

003
001
002
003

Apr
Nov
Nov
Nov

17,
27,
27,
27,

2009

2006

2006

2006

EQ 50MG BASE
EQ 100MG BASE

A062497 001 Aug 23, 1984

A062497 002 Jun 15, 1984

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
50MG BASE
100MG BASE
100MG BASE

A062119
A062119
A062463
A062463
A062763
A062763
A062418
A062418
A062434
A062442
A062631
A062631
A062479
A062479
A062469
A062469
A062594
A062594
A061717
A062142
A061717
A062142

20MG BASE

N050744 001 Sep 30, 1998

50MG BASE

N050007 001

100MG BASE

A063187 001 Jun 30, 1992

75MG BASE
100MG BASE
100MG BASE

N050582 002 Aug 13, 2001

N050582 001 Jul 22, 1985

A062653 001 Oct 30, 1985

100MG BASE/VIAL

A061953 001

100MG BASE/VIAL
200MG BASE/VIAL
200MG BASE/VIAL

A062450 001 Oct 27, 1983

A062450 002 Oct 27, 1983

A062569 002 Mar 09, 1988

100MG BASE/VIAL
200MG BASE/VIAL

A062992 001 Feb 16, 1989

A062992 002 Feb 16, 1989

100MG BASE/VIAL
200MG BASE/VIAL

N050442 002

N050442 001

100MG BASE

A062581 001 Mar 15, 1985

50MG BASE
100MG BASE
100MG BASE
100MG BASE
100MG BASE
100MG BASE
50MG BASE
100MG BASE

A062269
A062462
A062764
A062391
A062494
A062593
A062392
A062392

PERIOSTAT

COLLAGENEX
EQ
VIBRAMYCIN

PFIZER
EQ
CAPSULE, COATED PELLETS;ORAL

DOXYCYCLINE HYCLATE

PLIVA
EQ
CAPSULE, DELAYED RELEASE;ORAL

DORYX

MAYNE PHARMA INTL
EQ
EQ
WARNER CHILCOTT
EQ
INJECTABLE;INJECTION

DOXYCHEL HYCLATE

RACHELLE
EQ
DOXYCYCLINE

EUROHLTH INTL SARL
EQ
EQ
EQ
DOXYCYCLINE HYCLATE

HIKMA MAPLE
EQ
EQ
VIBRAMYCIN

PFIZER
EQ
EQ
TABLET;ORAL

DOXY-LEMMON

TEVA
EQ
DOXYCYCLINE HYCLATE

BLU CARIBE INC
EQ
HEATHER
EQ
INTERPHARM
EQ
MUTUAL PHARM
EQ
SUPERPHARM
EQ
WARNER CHILCOTT
EQ
WATSON LABS
EQ
EQ

002
001
001
002
001
002
001
002
001
001
001
002
001
002
001
002
001
002
001

001

002

002

003

001
001
001
001
001
001
002

May
May
Dec
Dec
Sep
Sep
Jan
Jan
Oct
Dec
Jul
Jul
Dec
Dec
Oct
Oct
Dec
Dec

May
Sep
Sep
Feb
Aug
Mar
Mar

24,
24,
07,
07,
02,
02,
28,
28,
19,
22,
24,
24,
23,
23,
31,
31,
05,
05,

11,
02,
30,
20,
28,
31,
31,

1985

1985

1983

1983

1988

1988

1983

1983

1984

1983

1986

1986

1983

1983

1984

1984

1985

1985

1983

1988

1982

1985

1985

1983

1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-124(of 347)

DISCONTINUED DRUG PRODUCT LIST

DOXYCYCLINE HYCLATE

TABLET;ORAL

PERIOSTAT

GALDERMA LABS LP

VIBRA-TABS

PFIZER

DOXYLAMINE SUCCINATE

CAPSULE;ORAL

UNISOM

PFIZER
TABLET;ORAL

DECAPRYN

SANOFI AVENTIS US
DOXY-SLEEP-AID

PAR PHARM
DOXYLAMINE SUCCINATE

COPLEY PHARM
QUANTUM PHARMICS

EQ 20MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N050783 001 Feb 02, 2001

EQ 100MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N050533 001

25MG

N019440 001 Feb 05, 1986

12.5MG
25MG

N006412 015

N006412 014

25MG

A070156 001 Jul 02, 1987

25MG
25MG

A088900 002 Feb 12, 1988

A088603 001 Aug 07, 1984

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

BENDECTIN

SANOFI AVENTIS US
10MG;10MG **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

DROMOSTANOLONE PROPIONATE

INJECTABLE;INJECTION

DROLBAN

LILLY
DRONABINOL

CAPSULE;ORAL

DRONABINOL

INSYS THERAP

DROPERIDOL

INJECTABLE;INJECTION

DROPERIDOL

ABRAXIS PHARM
ASTRAZENECA
HOSPIRA
IGI LABS INC

LUITPOLD
SMITH AND NEPHEW
SOLOPAK
WATSON LABS

N010598 002

50MG/ML

N012936 001

2.5MG
5MG
10MG

A078501 001 Aug 19, 2011

A078501 002 Aug 19, 2011

A078501 003 Aug 19, 2011

2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML

A070992
A070993
A072018
A071645
A072272
A072019
A072020
A072021
A072335
A071750
A071754
A071755
A073520
A073521
A073523

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Nov
Nov
Oct
Apr
Aug
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Nov
Nov
Nov

17,
17,
20,
07,
31,
19,
19,
19,
24,
06,
06,
06,
27,
27,
27,

1986

1986

1988

1988

1995

1988

1988

1988

1988

1988

1988

1988

1991

1991

1991

A072026
A072027
A072028
A071982

001
001
001
001

Apr
Apr
Apr
May

13,
13,
13,
04,

1989
1989
1989
1988

DROPERIDOL; FENTANYL CITRATE

INJECTABLE;INJECTION

FENTANYL CITRATE AND DROPERIDOL
ASTRAZENECA
2.5MG/ML;EQ
2.5MG/ML;EQ
2.5MG/ML;EQ
HOSPIRA
2.5MG/ML;EQ
INNOVAR
AKORN MFG
2.5MG/ML;EQ

0.05MG
0.05MG
0.05MG
0.05MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML

0.05MG BASE/ML

N016049 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

DYCLONINE HYDROCHLORIDE

SOLUTION;TOPICAL

DYCLONE

ASTRAZENECA

DYDROGESTERONE

TABLET;ORAL

GYNOREST

SOLVAY

DYPHYLLINE

ELIXIR;ORAL

NEOTHYLLINE

TEVA

INJECTABLE;INJECTION

NEOTHYLLINE

TEVA

TABLET;ORAL

DILOR

SAVAGE LABS

DILOR-400

SAVAGE LABS

NEOTHYLLINE

TEVA

ECHOTHIOPHATE IODIDE

FOR SOLUTION;OPHTHALMIC

PHOSPHOLINE IODIDE

WYETH PHARMS INC

ECONAZOLE NITRATE

CREAM;TOPICAL

SPECTAZOLE

MERZ PHARMS LLC

0.5% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

1% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N009925 002

5MG

10MG

N017388 001

N017388 002

160MG/15ML

N007794 003

250MG/ML

N009088 001

200MG

A084514 001

400MG

A084751 001

200MG

400MG

N007794 001

N007794 002

0.03%

0.06%

0.25%

N011963 002

N011963 004

N011963 003

1%

N018751 001 Dec 23, 1982

EDETATE CALCIUM DISODIUM

TABLET;ORAL

CALCIUM DISODIUM VERSENATE

MEDICIS
500MG

EDROPHONIUM CHLORIDE

INJECTABLE;INJECTION

EDROPHONIUM CHLORIDE

HOSPIRA
10MG/ML

WATSON LABS
10MG/ML

EDROPHONIUM CHLORIDE PRESERVATIVE FREE

WATSON LABS

10MG/ML

REVERSOL

ORGANON USA INC

10MG/ML

TENSILON

IGI LABS INC

10MG/ML

TENSILON PRESERVATIVE FREE

IGI LABS INC

10MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EFAVIRENZ

CAPSULE;ORAL

SUSTIVA

BRISTOL MYERS SQUIBB

6-125(of 347)

100MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N009925 001

N008922 002

A040131 001 Feb 24, 1998

A040044 001 Mar 20, 1996

A040043 001 Mar 20, 1996

A089624 001 May 13, 1988

N007959 001

N007959 002

N020972 002 Sep 17, 1998

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-126(of 347)

DISCONTINUED DRUG PRODUCT LIST

EFAVIRENZ

TABLET;ORAL

SUSTIVA

BRISTOL MYERS SQUIBB

EFLORNITHINE HYDROCHLORIDE

INJECTABLE;INJECTION

ORNIDYL

SANOFI AVENTIS US
ENALAPRIL MALEATE

TABLET;ORAL

ENALAPRIL MALEATE

APOTHECON

IVAX SUB TEVA PHARMS

KRKA DD NOVO MESTO

MYLAN

SANDOZ

SANDOZ INC

SUN PHARM INDS LTD

WATSON LABS

300MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N021360 001 Feb 01, 2002

200MG/ML

N019879 002 Nov 28, 1990

2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG

A075583
A075583
A075583
A075583
A075482
A075482
A075482
A075482
A075370
A075370
A075369
A075369
A075472
A075472
A075472
A075472
A075048
A075048
A075048
A075048
A075621
A075621
A075621
A075621
A075556
A075556
A075556
A075556
A075501
A075501
A075501
A075501

001
002
003
004
001
002
003
004
001
002
001
002
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

ENALAPRIL MALEATE; FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

LEXXEL

ASTRAZENECA
5MG;2.5MG
5MG;5MG

N020668 002 Oct 28, 1998

N020668 001 Dec 27, 1996

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

IVAX SUB TEVA PHARMS
5MG;12.5MG
10MG;25MG
SANDOZ INC
5MG;12.5MG
10MG;25MG

A075736
A075736
A076116
A076116

ENALAPRILAT

INJECTABLE;INJECTION

ENALAPRILAT

HOSPIRA
VASOTEC

BIOVAIL LABS INTL

001
002
001
002

Mar
Mar
Sep
Sep

25,
25,
19,
19,

2003

2003

2001

2001

1.25MG/ML
1.25MG/ML

A075456 001 Aug 22, 2000

A075571 001 Aug 22, 2000

1.25MG/ML

N019309 001 Feb 09, 1988

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6-127(of 347)

DISCONTINUED DRUG PRODUCT LIST

ENFLURANE

LIQUID;INHALATION

ENFLURANE

ABBOTT
ENOXACIN

TABLET;ORAL

PENETREX

SANOFI AVENTIS US

99.9%

A070803 001 Sep 08, 1987

200MG
400MG

N019616 004 Dec 31, 1991

N019616 005 Dec 31, 1991

ENOXAPARIN SODIUM

INJECTABLE;SUBCUTANEOUS

LOVENOX (PRESERVATIVE FREE)

SANOFI AVENTIS US
90MG/0.6ML (150MG/ML) **Federal
Register determination that product was

not discontinued or withdrawn for

safety or efficacy reasons**

EPINEPHRINE

AEROSOL, METERED;INHALATION

BRONKAID MIST

STERLING
EPINEPHRINE

ARMSTRONG PHARMS
PRIMATENE MIST

WYETH CONS
INJECTABLE;INJECTION

SUS-PHRINE SULFITE-FREE

FOREST LABS
INJECTABLE;INTRAMUSCULAR

EPI E Z PEN JR

MYLAN SPECLT
EPIPEN E Z PEN

MYLAN SPECLT
EPINEPHRINE BITARTRATE

AEROSOL, METERED;INHALATION

BRONITIN MIST

WYETH CONS
MEDIHALER-EPI

3M

N020164 006 Jun 02, 2000

0.25MG/INH

N016803 001

0.2MG/INH

A087907 001 May 23, 1984

0.2MG/INH

N016126 001

1.5MG/AMP
5MG/ML

N007942 003 Feb 05, 1999

N007942 001

0.15MG/DELIVERY

N019430 004 Aug 03, 1995

0.3MG/DELIVERY

N019430 003 Aug 03, 1995

0.3MG/INH

N016126 002

0.3MG/INH

N010374 003

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DURANEST

ASTRAZENECA
0.005MG/ML;1%
0.005MG/ML;1.5%
DENTSPLY PHARM
0.005MG/ML;1.5%

N017751 006

N017751 007

N021384 001

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CITANEST FORTE

ASTRAZENECA
0.005MG/ML;4%

N014763 008

EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DURANEST

ASTRAZENECA
0.005MG/ML;0.5%

N017751 004

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE

CARLISLE
0.01MG/ML;2%
0.02MG/ML;2%
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

EUROHLTH INTL SARL
0.01MG/ML;1%
0.01MG/ML;2%
GRAHAM CHEM
0.01MG/ML;2%
0.02MG/ML;2%
HOSPIRA
0.005MG/ML;1%
0.005MG/ML;1.5%
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE

ABBOTT
0.01MG/ML;1%
BEL MAR
0.01MG/ML;1%
0.01MG/ML;2%

A084720 001

A084732 001

A080406
A080406
A080504
A080504
A089649
A089650

001

002

004
005
001
001

A083154 001

A080820 001

A080757 001

Oct
Oct
Jun
Jun

19,
19,
21,
21,

1983

1983

1988

1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-128(of 347)

DISCONTINUED DRUG PRODUCT LIST

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE

DELL LABS
0.01MG/ML;1%

0.01MG/ML;2%

INTL MEDICATION
0.01MG/ML;1%

WATSON LABS
0.01MG/ML;1%

0.01MG/ML;1%

0.01MG/ML;2%

LIDOCATON

PHARMATON
0.01MG/ML;2%

0.02MG/ML;2%

XYLOCAINE DENTAL WITH EPINEPHRINE

DENTSPLY PHARM

0.01MG/ML;2%

0.02MG/ML;2%

XYLOCAINE W/ EPINEPHRINE

ASTRAZENECA

0.005MG/ML;1%

0.005MG/ML;1.5%

0.005MG/ML;2%

FRESENIUS KABI USA

0.01MG/ML;2%

PATCH;IONTOPHORESIS, TOPICAL

LIDOSITE TOPICAL SYSTEM KIT

VYTERIS

1.05MG/PATCH;100MG/PATCH

SOLUTION;IONTOPHORESIS

IONTOCAINE

IOMED

0.01MG/ML;2%

SOLUTION;IONTOPHORESIS, TOPICAL

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

EMPI
0.01MG/ML;2%

EPINEPHRINE; PROCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

PROCAINE HYDROCHLORIDE W/ EPINEPHRINE

BEL MAR

0.02MG/ML;1%

0.02MG/ML;2%

EPIRUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

EPIRUBICIN HYDROCHLORIDE

EBEWE PHARMA

A083389
A083390
A086402
A080377
A085463
A080377

001

001

001

003

001

004

A084729 001 Aug 17, 1983

A084728 001 Aug 17, 1983

N021381 001

N021381 002

N010418
N010418
N010418
N006488

006

010

008

003

N021504 001 May 06, 2004

N020530 001 Dec 21, 1995

N021486 001 Oct 26, 2004

A080758 001

A080759 001

50MG/25ML (2MG/ML)

200MG/100ML (2MG/ML)

50MG/25ML (2MG/ML)

50MG/25ML (2MG/ML)

200MG/100ML (2MG/ML)

50MG/25ML (2MG/ML)

200MG/100ML (2MG/ML)

A065339
A065339
A065343
A090266
A090266
A065371
A065371

50MG/VIAL

200MG/VIAL

N050807 001 Sep 15, 2006

N050807 002 Sep 15, 2006

EPLERENONE

TABLET;ORAL

INSPRA

GD SEARLE LLC

100MG

N021437 003 Sep 27, 2002

EPROSARTAN MESYLATE

TABLET;ORAL

TEVETEN

ABBVIE

EQ 300MG BASE

N020738 004 Dec 22, 1997

HOSPIRA

MUSTAFA NEVSAT

MYLAN INSTITUTIONAL

INJECTABLE;IV (INFUSION)

EPIRUBICIN HYDROCHLORIDE

HOSPIRA

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

TEVETEN HCT

ABBVIE
600MG;12.5MG

600MG;25MG

ERGOCALCIFEROL

CAPSULE;ORAL

DELTALIN

LILLY
VITAMIN D

CHASE CHEM
EVERYLIFE
IMPAX LABS

001
002
002
001
002
001
002

Dec
Dec
Apr
Apr
Apr
Nov
Nov

22,
22,
19,
15,
15,
28,
28,

2009

2009

2007

2011

2011

2007

2007

N021268 001 Nov 01, 2001

N021268 002 Nov 01, 2001

50,000 IU

A080884 001

50,000 IU

50,000 IU

50,000 IU

A080747 001

A080956 001

A080951 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-129(of 347)

DISCONTINUED DRUG PRODUCT LIST

ERGOCALCIFEROL

CAPSULE;ORAL

VITAMIN D

LANNETT
VITARINE
WEST WARD

50,000 IU

50,000 IU

50,000 IU

A080825 001

A084053 001

A083102 001

1MG

N018706 001 Jan 18, 1983

1MG/ML

N018418 001

1MG

1MG

1MG

A088891 001 Nov 01, 1985

A086433 001 May 27, 1982

A087244 001 Aug 16, 1982

1MG

A088207 001 Mar 22, 1984

0.5MG

N017993 003

0.5MG

1MG

A085153 001

A087417 001

0.5MG

1MG

A084868 001

A085809 001

1MG

A085020 002

0.5MG

0.5MG

1MG

1MG

0.5MG

1MG

0.5MG

1MG

0.5MG

1MG

0.5MG

1MG

0.5MG

0.5MG

1MG

1MG

A085899
A086265
A085900
A086264
A086984
A086985
A087407
A087552
A089233
A089234
A088013
A088014
A084930
A087233
A085177
A087183

0.5MG

1MG

A086189 001

A086188 001

0.5MG

1MG

HYDROGENATED ERGOT ALKALOIDS

IVAX PHARMS
0.5MG

1MG

N009087 002

N009087 001

ERGOLOID MESYLATES

CAPSULE;ORAL

HYDERGINE LC

NOVARTIS
SOLUTION;ORAL

HYDERGINE

NOVARTIS
TABLET;ORAL

ERGOLOID MESYLATES

MUTUAL PHARM
WATSON LABS
GERIMAL

WATSON LABS
HYDERGINE

NOVARTIS
TABLET;SUBLINGUAL

ALKERGOT

SANDOZ
CIRCANOL

3M
DEAPRIL-ST

BRISTOL MYERS SQUIBB
ERGOLOID MESYLATES

KV PHARM

LEDERLE
MUTUAL PHARM
SUPERPHARM
VANGARD
WATSON LABS

GERIMAL

WATSON LABS
HYDERGINE

NOVARTIS

ERGOTAMINE TARTRATE

AEROSOL, METERED;INHALATION

MEDIHALER ERGOTAMINE

3M
TABLET;SUBLINGUAL

ERGOSTAT

WATSON LABS INC
WIGRETTES

ORGANON USA INC

001

001

001

001

001

001

001

001

001
001
001
001
001

001

001

001

Sep
Sep
Sep
Sep

23,
23,
20,
20,

1986

1986

1982

1982

A087186 001

A087185 001

0.36MG/INH

N012102 001

2MG

A088337 001 Jun 08, 1984

2MG

A086750 001 Jul 29, 1982

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6-130(of 347)

DISCONTINUED DRUG PRODUCT LIST

ERLOTINIB HYDROCHLORIDE

TABLET;ORAL

ERLOTINIB HYDROCHLORIDE

MYLAN PHARMS INC

TEVA PHARMS USA

EQ
EQ
EQ
EQ
EQ

25MG BASE
100MG BASE
150MG BASE
100MG BASE
150MG BASE

ERYTHROMYCIN

CAPSULE, DELAYED REL PELLETS;ORAL

ERYC

PARKE DAVIS
250MG
250MG
WARNER CHILCOTT LLC
250MG
ERYC 125

PARKE DAVIS
125MG
ERYC SPRINKLES

HOSPIRA
125MG
ERYTHROMYCIN

BARR
250MG
GEL;TOPICAL

E-GLADES

RENAISSANCE PHARMA
2%
EMGEL

ALTANA
2%
LOTION;TOPICAL

E-SOLVE 2

SYOSSET
2%
OINTMENT;OPHTHALMIC

ERYTHROMYCIN

PHARMADERM
5MG/GM
PHARMAFAIR
5MG/GM
ILOTYCIN

DISTA
0.5%
POWDER;FOR RX COMPOUNDING

ERYTHROMYCIN

PADDOCK LLC
100%
SOLUTION;TOPICAL

A/T/S

TARO PHARMS NORTH

2%
ERYDERM

ARBOR PHARMS INC
2%
ERYMAX

MERZ PHARMS
2%
ERYTHRA-DERM

PADDOCK LLC
2%
ERYTHROMYCIN

ALPHARMA US PHARMS
1.5%
2%
2%
2%
2%
BAUSCH AND LOMB
2%
LILLY
2%
PHARMAFAIR
1.5%
2%
RENAISSANCE PHARMA
2%
SANSAC

DOW PHARM
2%
STATICIN

WESTWOOD SQUIBB
1.5%
T-STAT

WESTWOOD SQUIBB
2%
SWAB;TOPICAL

C-SOLVE-2

IVAX SUB TEVA PHARMS
2%
ERYCETTE

JOHNSON AND JOHNSON
2%
ERYTHROMYCIN

FOUGERA PHARMS
2%
RENAISSANCE PHARMA
2%

A091002
A091002
A091002
A091059
A091059

001
002
003
002
003

Jun
Jun
Jun
Aug
Aug

11,
11,
11,
28,
28,

2014

2014

2014

2015

2015

A062546 001 Jul 25, 1985

A062618 001 Sep 25, 1985

A062338 001

A062648 001 Oct 24, 1985

N050593 001 Jul 22, 1985

A063098 001 May 04, 1989

A065009 001 Mar 18, 2002

A063107 001 Aug 23, 1991

A062467 001 Jul 03, 1985

A062446 001 Sep 26, 1983

A062481 001 Apr 05, 1984

N050368 001

N050610 001 Nov 07, 1986

A062405 001 Nov 18, 1982

A062290 001

A062508 002 Jul 11, 1985

A062687 001 Feb 05, 1988

A062328
A062326
A062327
A062342
A062957
A064039
N050532
A062485
A062616
A064127

001
001
001
001
001
001
001

001
001
001

Apr
Apr
Apr
Feb
Jul
Jan

19,
19,
19,
25,
21,
27,

1982

1982

1982

1982

1988

1994

Jul 11, 1984

Jul 25, 1985

Feb 14, 1997

A062522 001 Jan 24, 1985

N050526 001

A062436 001 Mar 09, 1983

A062751 001 Jul 30, 1993

N050594 001 Feb 15, 1985

A065320 001 Jul 25, 2006

A064128 001 Jul 03, 1996

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6-131(of 347)

DISCONTINUED DRUG PRODUCT LIST

ERYTHROMYCIN

SWAB;TOPICAL

T-STAT

WESTWOOD SQUIBB

2%

TABLET, DELAYED RELEASE;ORAL

E-BASE

BARR

333MG

333MG

500MG

E-MYCIN

ARBOR PHARMS INC

250MG

333MG

ILOTYCIN

DISTA

250MG

R-P MYCIN

SOLVAY

250MG

ROBIMYCIN

ROBINS AH

250MG

ERYTHROMYCIN ESTOLATE

CAPSULE;ORAL

ERYTHROMYCIN ESTOLATE

BARR

IVAX SUB TEVA PHARMS

WATSON LABS

ILOSONE

LILLY

FOR SUSPENSION;ORAL

ILOSONE

DISTA

SUSPENSION;ORAL

ERYTHROMYCIN ESTOLATE

ALPHARMA US PHARMS

G AND W LABS INC

LIFE LABS

ILOSONE

LILLY

SUSPENSION/DROPS;ORAL

ILOSONE

LILLY

TABLET;ORAL

ILOSONE

LILLY

TABLET, CHEWABLE;ORAL

ILOSONE

DISTA

EQ
EQ
EQ
EQ

125MG
250MG
250MG
250MG

A062748 001 Jul 23, 1987

A063028 001 May 15, 1990

A063086 001 May 15, 1990

A062999 001 Nov 25, 1988

A060272 001

A060272 002

A061910 001

A061659 001

A061633 001

BASE

BASE

BASE

BASE

A062162
A062162
A062237
A062087

001

002

001

001

EQ 125MG BASE

EQ 250MG BASE

A061897 001

A061897 002

EQ 125MG BASE/5ML

A061893 001

EQ
EQ
EQ
EQ
EQ

125MG
250MG
125MG
250MG
250MG

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

A062353
A062409
A062169
A062169
A062362

001
001
001
002
001

EQ
EQ
EQ
EQ

125MG
125MG
250MG
250MG

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

A061894
N050010
A061894
N050010

001

001

002

002

EQ 100MG BASE/ML

A061894 003

EQ 500MG BASE

A061896 001

EQ 125MG BASE

EQ 250MG BASE

A061895 001

A061895 002

ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL

SUSPENSION;ORAL

ILOSONE SULFA

LILLY

EQ 125MG BASE/5ML;EQ 600MG BASE/5ML

ERYTHROMYCIN ETHYLSUCCINATE

GRANULE;ORAL

ERYTHROMYCIN ETHYLSUCCINATE

ANI PHARMS INC

EQ
PEDIAMYCIN

ROSS LABS

EQ
SUSPENSION;ORAL

E-MYCIN E

PHARMACIA AND UPJOHN
EQ
EQ
E.E.S. 200

ARBOR PHARMS LLC

EQ

Nov
Dec
Oct
Oct
Dec

18,
16,
17,
17,
17,

1982

1982

1990

1990

1982

N050599 001 Sep 29, 1989

200MG BASE/5ML

A062055 001

200MG BASE/5ML

A062305 001

200MG BASE/5ML

400MG BASE/5ML

A062198 001

A062198 002

200MG BASE/5ML

A061639 001

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ERYTHROMYCIN ETHYLSUCCINATE

SUSPENSION;ORAL

E.E.S. 400

ARBOR PHARMS LLC

EQ
ERYTHROMYCIN ETHYLSUCCINATE

ALPHARMA US PHARMS

EQ
EQ
DISTA

EQ
EQ
NASKA

EQ
PARKE DAVIS

EQ
EQ
PHARMAFAIR

EQ
EQ
PEDIAMYCIN

ARBOR PHARMS LLC

EQ
PEDIAMYCIN 400

ARBOR PHARMS LLC

EQ
WYAMYCIN E

WYETH AYERST

EQ
EQ
SUSPENSION/DROPS;ORAL

PEDIAMYCIN

ROSS LABS

EQ
TABLET;ORAL

E.E.S. 400

ARBOR PHARMS LLC

EQ
ERYTHROMYCIN ETHYLSUCCINATE

BARR

EQ
MYLAN

EQ
TABLET, CHEWABLE;ORAL

E.E.S.

ARBOR PHARMS INC

EQ
ERYPED

ARBOR PHARMS INC

EQ
PEDIAMYCIN

ROSS LABS

EQ

400MG BASE/5ML

A061639 002

200MG
400MG
200MG
400MG
400MG
200MG
400MG
200MG
400MG

A062200
A062200
A062177
A062177
A062674
A062231
A062231
A062559
A062558

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

200MG BASE/5ML

A062304 001

400MG BASE/5ML

A062304 002

200MG BASE/5ML

400MG BASE/5ML

A062123 002

A062123 001

100MG BASE/2.5ML

A062305 002

400MG BASE

A061905 001

400MG BASE

400MG BASE

A062256 001

A062847 001 Sep 14, 1988

200MG BASE

N050297 002

200MG BASE

N050297 003 Jul 05, 1988

200MG BASE

A062306 001

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL

GRANULE;ORAL

ERYZOLE

ALRA

EQ 200MG BASE/5ML;EQ 600MG BASE/5ML

PEDIAZOLE

ROSS LABS

EQ 200MG BASE/5ML;EQ 600MG BASE/5ML

ERYTHROMYCIN GLUCEPTATE

INJECTABLE;INJECTION

ILOTYCIN GLUCEPTATE

DISTA

ERYTHROMYCIN LACTOBIONATE

INJECTABLE;INJECTION

ERYTHROCIN

ABBOTT

HOSPIRA

ERYTHROMYCIN

ELKINS SINN

ERYTHROMYCIN LACTOBIONATE

ABRAXIS PHARM

BAXTER HLTHCARE

TEVA PARENTERAL

001

002

001

002

001 Mar 10, 1987

001

002

001 Mar 15, 1985

001 Mar 15, 1985

A062758 001 Jun 15, 1988

N050529 001

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

N050370 001

N050370 002

N050370 003

EQ
EQ
EQ
EQ
EQ

A062586
A062586
N050182
N050182
N050609

500MG BASE/VIAL

1GM BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

1GM BASE/VIAL

001 Jan 04, 1988

002 Jan 04, 1988

002

003

002 Sep 24, 1986

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

A062563 001 Mar 28, 1985

A062563 002 Mar 28, 1985

EQ
EQ
EQ
EQ
EQ
EQ

A062604
A062604
A062993
A062993
A063253
A063253

500MG BASE/VIAL

1GM BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

001
002
001
002
001
002

Nov
Nov
May
May
Jul
Jul

24,
24,
09,
09,
30,
30,

1986

1986

1989

1989

1993

1993

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ERYTHROMYCIN STEARATE

TABLET;ORAL

BRISTAMYCIN

BRISTOL
ERYPAR

PARKE DAVIS
WARNER CHILCOTT
ERYTHROCIN STEARATE

ARBOR PHARMS LLC
ERYTHROMYCIN STEARATE

ANI PHARMS INC

IVAX SUB TEVA PHARMS

LEDERLE
MYLAN
PUREPAC PHARM
WATSON LABS
ETHRIL 250

BRISTOL MYERS SQUIBB
ETHRIL 500

BRISTOL MYERS SQUIBB
PFIZER-E

PFIZER
WYAMYCIN S

WYETH AYERST
ESCITALOPRAM OXALATE

CAPSULE;ORAL

ESCITALOPRAM OXALATE

MYLAN PHARMS INC

ESMOLOL HYDROCHLORIDE

INJECTABLE;INJECTION

BREVIBLOC

BAXTER HLTHCARE
ESTAZOLAM

TABLET;ORAL

PROSOM

ABBOTT

EQ 250MG BASE
EQ 250MG BASE

A061304 001

A061887 001

EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE

A062032 001

A062032 002

A062322 001

EQ 125MG BASE
EQ 500MG BASE

A060359 002

A060359 003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A061591
A061461
A063179
A061461
A062089
A062089
A061505
A061505
A061743
A062121
A062121

250MG
500MG
500MG
250MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001

002

001 May 15, 1990

001

001

002

001

002

001

002

001

EQ 250MG BASE

A061605 001

EQ 500MG BASE

A061605 002

EQ 250MG BASE
EQ 500MG BASE

A061791 001

A061791 002

EQ 250MG BASE
EQ 500MG BASE

A061675 001

A061675 002

EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE

A077660 001 Jul 31, 2007

A077660 002 Jul 31, 2007

A077660 003 Jul 31, 2007

10MG/ML
20MG/ML

N019386 003 Aug 15, 1988

N019386 007 May 28, 2003

1MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

2MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N019080 001 Dec 26, 1990

ESTRADIOL

FILM, EXTENDED RELEASE;TRANSDERMAL

ESCLIM

WOMEN FIRST HLTHCARE 0.025MG/24HR
0.0375MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
ESTRADIOL

ORTHO MCNEIL PHARM
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
FEMPATCH

PARKE DAVIS
0.025MG/24HR

N019080 002 Dec 26, 1990

N020847
N020847
N020847
N020847
N020847

001
002
003
004
005

Aug
Aug
Aug
Aug
Aug

04,
04,
04,
04,
04,

1998

1998

1998

1998

1998

N021048 001 Sep 20, 1999

N021048 002 Sep 20, 1999

N021048 003 Sep 20, 1999

N020417 001 Dec 03, 1996

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ESTRADIOL

FILM, EXTENDED RELEASE;TRANSDERMAL

VIVELLE
NOVARTIS
0.025MG/24HR
0.0375MG/24HR
0.075MG/24HR
GEL;TOPICAL
ESTROGEL
ASCEND THERAPS US
0.06%
TABLET;ORAL
ESTRACE
BRISTOL MYERS SQUIBB
0.5MG
1MG
2MG
ESTRADIOL
EPIC PHARMA INC
0.5MG
1MG
2MG
LANNETT HOLDINGS INC
0.5MG
1MG
2MG
GYNODIOL
DURAMED PHARMS BARR
0.5MG
1MG
1.5MG
2MG
INNOFEM
NOVO NORDISK INC
0.5MG
1MG
2MG
TABLET;VAGINAL
ESTRADIOL
AMNEAL PHARMS
10MCG
VAGIFEM
NOVO NORDISK INC
25MCG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ESTRADIOL CYPIONATE
INJECTABLE;INJECTION
DEPO-ESTRADIOL
PHARMACIA AND UPJOHN
ESTRADIOL CYPIONATE
WATSON LABS

WATSON LABS INC

A081295 001 Jun 30, 1993

A084499 001
A084500 001
A040275
A040275
A040275
A040138
A040138
A040138

001
002
003
001
002
003

Dec
Dec
Dec
Jan
Jan
Jan

29,
29,
29,
30,
30,
30,

1998
1998
1998
1998
1998
1998

A040212
A040212
A040212
A040212

001
002
003
004

Dec
Dec
Dec
Dec

29,
29,
29,
29,

1997
1997
1997
1997

A040312 001 Nov 19, 1999

A040312 002 Nov 19, 1999
A040312 003 Nov 19, 1999

A205256 001 May 29, 2015

N020908 001 Mar 26, 1999

A085470 001
A085470 002

5MG/ML

A085620 001

ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION

DEPO-TESTADIOL

PHARMACIA AND UPJOHN
2MG/ML;50MG/ML
TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE

WATSON LABS
2MG/ML;50MG/ML

WATSON LABS

N021166 001 Feb 09, 2004

1MG/ML
3MG/ML

ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE

INJECTABLE;INTRAMUSCULAR

LUNELLE

PHARMACIA AND UPJOHN
5MG/0.5ML;25MG/0.5ML

ESTRADIOL VALERATE

INJECTABLE;INJECTION

ESTRADIOL VALERATE

SANDOZ

N020323 005 Aug 16, 2000

N020323 001 Oct 28, 1994
N020323 003 Oct 28, 1994

10MG/ML
20MG/ML
40MG/ML
10MG/ML
40MG/ML
20MG/ML

N020874 001 Oct 05, 2000

N017968 001

A085603 001 Mar 13, 1986

A040628
A040628
A040628
A083546
A083714
A083547

001 Oct 04, 2007

002 Oct 04, 2007

003 Oct 04, 2007

001

001

001

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ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE

INJECTABLE;INJECTION

DITATE-DS

SAVAGE LABS
8MG/ML;180MG/ML
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE

WATSON LABS
4MG/ML;90MG/ML
8MG/ML;180MG/ML
ESTRADIOL; NORGESTIMATE
TABLET;ORAL
PREFEST
TEVA WOMENS

ESTROGENS, CONJUGATED
TABLET;ORAL
PREMARIN
WYETH PHARMS INC

N021040 001 Oct 22, 1999

2.5MG

N004782 002

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

TABLET;ORAL-28

PREMPHASE (PREMARIN;CYCRIN 14/14)

WYETH PHARMS INC

0.625MG;0.625MG;N/A,5MG
PREMPRO (PREMARIN;CYCRIN)

WYETH PHARMS INC

0.625MG;0.625MG;2.5MG;2.5MG
ESTROGENS, CONJUGATED; MEPROBAMATE

TABLET;ORAL

MILPREM-200

MEDPOINTE PHARM HLC
0.45MG;200MG
MILPREM-400

MEDPOINTE PHARM HLC
0.45MG;400MG
PMB 200

WYETH AYERST
0.45MG;200MG
PMB 400

WYETH AYERST
0.45MG;400MG

ESTERIFIED ESTROGENS

PVT FORM

SANDOZ
ESTRATAB

SOLVAY

A085865 001
A085860 001

1MG,1MG;1MG,1MG;N/A,0.09MG **Federal
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**

ESTROGENS, CONJUGATED SYNTHETIC A

CREAM;VAGINAL

SYNTHETIC CONJUGATED ESTROGENS A

TEVA WOMENS
0.625MG/GM

ESTROGENS, ESTERIFIED

TABLET;ORAL

AMNESTROGEN

BRISTOL MYERS SQUIBB

A086423 001

N021788 001 Nov 28, 2008

N020303 002 Dec 30, 1994

N020303 001 Dec 30, 1994

N011045 002

N011045 001

N010971 005

N010971 003

0.3MG
0.625MG
1.25MG
2.5MG

A083266
A083266
A083266
A083266

001

002

003

004

0.625MG
1.25MG
2.5MG
1.25MG

A083414
A083765
A085907
A085302

001

001

001

001

0.3MG
0.625MG
1.25MG
2.5MG

A086715
A083209
A083856
A083857

001

001

001

001

0.625MG
1.25MG

A084215 001

A083376 002

0.625MG
1.25MG
2.5MG

A085076 001

A085008 001

A085007 001

2MG/ML

A083488 001

2MG/ML
5MG/ML

A083397 001

A085239 001

EVEX

ROCHE PALO
FEMOGEN

PVT FORM

ESTRONE

INJECTABLE;INJECTION

ESTROGENIC SUBSTANCE

WYETH AYERST
ESTRONE

WATSON LABS

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ESTRONE

INJECTABLE;INJECTION

NATURAL ESTROGENIC SUBSTANCE-ESTRONE

WATSON LABS

2MG/ML

THEELIN

PARKEDALE

1MG/ML

2MG/ML

5MG/ML

ESTROPIPATE

CREAM;VAGINAL

OGEN

PHARMACIA AND UPJOHN

TABLET;ORAL

ESTROPIPATE

DURAMED PHARMS BARR

MYLAN

WATSON LABS

ORTHO-EST

SUN PHARM INDS INC

ESZOPICLONE

TABLET;ORAL

ESZOPICLONE

WOCKHARDT LTD

ETHACRYNIC ACID

TABLET;ORAL

EDECRIN

ATON

ETHAMBUTOL HYDROCHLORIDE

TABLET;ORAL

MYAMBUTOL

STI PHARMA LLC

ETHCHLORVYNOL

CAPSULE;ORAL

ETHCHLORVYNOL

BANNER PHARMACAPS

PLACIDYL

ABBVIE

ETHINAMATE

CAPSULE;ORAL

VALMID

DISTA

ETHINYL ESTRADIOL

TABLET;ORAL

ESTINYL

SCHERING

FEMINONE

PHARMACIA AND UPJOHN

LYNORAL

ORGANON USA INC

A085237 001 Nov 23, 1982

N003977 001

N003977 002

N003977 003

1.5MG/GM

A084710 001

0.75MG

1.5MG

3MG

3MG

6MG

A040296
A040296
A040296
A040359
A081216

0.75MG

1.5MG

A089567 001 Feb 27, 1991

A089582 001 Jul 17, 1991

1MG

2MG

3MG

A091165 001 Jul 14, 2011

A091165 002 Jul 14, 2011

A091165 003 Jul 14, 2011

50MG

N016092 002

200MG

500MG

N016320 002

N016320 004

100MG

200MG

500MG

750MG

A084463
A084463
A084463
A084463

001

002

003

004

100MG

200MG

500MG

750MG

N010021
N010021
N010021
N010021

004

007

002

010

500MG

N009750 001

0.02MG

0.05MG

0.5MG

N005292 001

N005292 002

N005292 003

0.05MG

N016649 001

0.01MG

0.05MG

N005490 003

N005490 002

001
002
003
003
001

Nov
Nov
Nov
Aug
Sep

01,
01,
01,
26,
23,

1999

1999

1999

1999

1993

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

TABLET;ORAL-21

DEMULEN 1/35-21

GD SEARLE LLC

0.035MG;1MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

DEMULEN 1/50-21

GD SEARLE LLC

0.05MG;1MG

ZOVIA 1/35E-21

WATSON LABS

0.035MG;1MG

ZOVIA 1/50E-21

WATSON LABS

0.05MG;1MG

TABLET;ORAL-28

DEMULEN 1/35-28

GD SEARLE LLC

0.035MG;1MG

DEMULEN 1/50-28

GD SEARLE LLC

0.05MG;1MG

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE

TABLET;ORAL-28

NORQUEST FE

GD SEARLE LLC
0.035MG;75MG;1MG

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE

TABLET;ORAL-28

NORLESTRIN FE 1/50

PARKE DAVIS
0.05MG;75MG;1MG

NORLESTRIN FE 2.5/50

PARKE DAVIS
0.05MG;75MG;2.5MG

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET;ORAL

LYBREL

WYETH PHARMS INC
0.02MG;0.09MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

PREVEN EMERGENCY CONTRACEPTIVE KIT

TEVA BRANDED PHARM

0.05MG;0.25MG

TABLET;ORAL-21

ALESSE

WYETH PHARMS

0.02MG;0.1MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

AVIANE-21

DURAMED PHARMS BARR

0.02MG;0.1MG

ENPRESSE-21

DURAMED PHARMS BARR

0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1

25MG

LESSINA-21

BARR

0.02MG;0.1MG

LEVLITE

BAYER HLTHCARE

0.02MG;0.1MG

LEVONORGESTREL AND ETHINYL ESTRADIOL

BARR

0.02MG;0.1MG

LEVORA 0.15/30-21

WATSON LABS

0.03MG;0.15MG

NORDETTE-21

TEVA BRANDED PHARM

0.03MG;0.15MG

PORTIA-21

BARR

0.03MG;0.15MG

TRIPHASIL-21

WYETH PHARMS

0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1

25MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

TRIVORA-21

WATSON LABS

0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1

25MG

TABLET;ORAL-28

ALESSE

WYETH PHARMS

0.02MG;0.1MG

6-137(of 347)

N018168 001

N016927 001

A072720 001
Dec 30, 1991

A072722 001
Dec 30, 1991

N018160 001

N016936 001

N018926 001
Jul 18, 1986

N016766 001

N016854 001

N021864 001
May 22, 2007

N020946 001
Sep 01, 1998

N020683 001
Mar 27, 1997

A075796 002
Apr 30, 2001

A075809 001
Jul 16, 2001

A075803 001
Mar 20, 2002

N020860 001
Jul 13, 1998

A075862 001
Apr 29, 2003

A073592 001
Dec 13, 1993

N018668 001
May 10, 1982

A075866 001
May 23, 2002

N019192 001
Nov 01, 1984

A074538 001
Dec 18, 1997

N020683 002
Mar 27, 1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET;ORAL-28

LEVLITE

BAYER HLTHCARE
0.02MG;0.1MG

LEVONORGESTREL AND ETHINYL ESTRADIOL

BARR
0.02MG;0.1MG

NORDETTE-28

TEVA BRANDED PHARM
0.03MG;0.15MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

TRIPHASIL-28

WYETH PHARMS INC
0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1

25MG

ETHINYL ESTRADIOL; NORELGESTROMIN

FILM, EXTENDED RELEASE;TRANSDERMAL

ORTHO EVRA

JANSSEN PHARMS
0.035MG/24HR;0.15MG/24HR **Federal

Register determination that product was

not discontinued or withdrawn for

safety or efficacy reasons**

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-21

BALZIVA-21

BARR

0.035MG;0.4MG

BREVICON 21-DAY

ACTAVIS LABS UT INC

0.035MG;0.5MG

GENCEPT 10/11-21

BARR

0.035MG;0.035MG;0.5MG;1MG

MODICON 21

ORTHO MCNEIL PHARM

0.035MG;0.5MG

N.E.E. 1/35 21

LPI

0.035MG;1MG

NORCEPT-E 1/35 21

ORTHO MCNEIL PHARM

0.035MG;1MG

NORETHIN 1/35E-21

WATSON LABS

0.035MG;1MG

NORETHINDRONE AND ETHINYL ESTRADIOL

WATSON LABS
0.035MG;0.4MG

0.035MG;0.5MG

0.035MG;1MG

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)

WATSON LABS
0.035MG;0.035MG;0.5MG;1MG

NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)

WATSON LABS

0.035MG;0.035MG;0.5MG;1MG

NORTREL 0.5/35-21

BARR

0.035MG;0.5MG

ORTHO-NOVUM 1/35-21

ORTHO MCNEIL PHARM

0.035MG;1MG

ORTHO-NOVUM 10/11-21

ORTHO MCNEIL JANSSEN

0.035MG;0.035MG;0.5MG;1MG

ORTHO-NOVUM 7/14-21

ORTHO MCNEIL PHARM

0.035MG;0.035MG;0.5MG;1MG

ORTHO-NOVUM 7/7/7-21

JANSSEN PHARMS

0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M

G

OVCON-35

WARNER CHILCOTT

0.035MG;0.4MG

OVCON-50

WARNER CHILCOTT

0.05MG;1MG

TRI-NORINYL 21-DAY

ACTAVIS LABS UT INC

0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG

TABLET;ORAL-28

GENCEPT 10/11-28

BARR

0.035MG;0.035MG;0.5MG;1MG

N.E.E. 1/35 28

LPI

0.035MG;1MG

NORCEPT-E 1/35 28

ORTHO MCNEIL PHARM

0.035MG;1MG

NORETHIN 1/35E-28

WATSON LABS

0.035MG;1MG

6-138(of 347)

N020860 002
Jul 13, 1998

A075862 002
Apr 29, 2003

N018782 001
Jul 21, 1982

N019190 001
Nov 01, 1984

N021180 001
Nov 20, 2001

A076198 001
Apr 22, 2004

N017566 001

A072694 001
Feb 28, 1992

N017488 001

A071541 001
Dec 14, 1987

A071545 001
Feb 09, 1989

A071480 001
Apr 12, 1988

A078379 001
Feb 23, 2010

A070684 001
Jan 29, 1987

A070685 001
Jan 29, 1987

A071043 001
Apr 01, 1988

A071041 001
Sep 24, 1991

A072692 001
Feb 28, 1992

N017489 002

N018354 001
Jan 11, 1982

N019004 001
Apr 04, 1984

N018985 001
Apr 04, 1984

N018127 001

N018128 001

N018977 001
Apr 13, 1984

A072697 001
Feb 28, 1992

A071542 001
Dec 14, 1987

A071546 001
Feb 09, 1989

A071481 001
Apr 12, 1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-28

NORETHINDRONE AND ETHINYL ESTRADIOL

WATSON LABS
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M

G

NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)

WATSON LABS

0.035MG,0.035MG;0.035MG,0.035MG;0.5MG,1

MG;0.5MG,1MG

ORTHO-NOVUM 10/11-28

ORTHO MCNEIL JANSSEN

0.035MG;0.035MG;0.5MG;1MG

ORTHO-NOVUM 7/14-28

ORTHO MCNEIL PHARM

0.035MG;0.035MG;0.5MG;1MG

OVCON-35

WARNER CHILCOTT LLC

0.035MG;0.4MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

OVCON-50

WARNER CHILCOTT LLC

0.05MG;1MG

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

CAPSULE;ORAL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

WARNER CHILCOTT

0.02MG;1MG

TABLET;ORAL

FEMHRT

WARNER CHILCOTT LLC

0.005MG;1MG

TABLET;ORAL-21

ESTROSTEP 21

WARNER CHILCOTT LLC

0.02MG;0.035MG;0.03MG;1MG;1MG;1MG

NORLESTRIN 21 1/50

PARKE DAVIS

0.05MG;1MG

NORLESTRIN 21 2.5/50

PARKE DAVIS

0.05MG;2.5MG

TABLET;ORAL-28

NORLESTRIN 28 1/50

PARKE DAVIS

0.05MG;1MG

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL-21

ORTHO CYCLEN-21

JANSSEN PHARMS

0.035MG;0.25MG

ORTHO TRI-CYCLEN

JANSSEN PHARMS

0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;

0.25MG

TABLET;ORAL-28

NORGESTIMATE AND ETHINYL ESTRADIOL

WATSON LABS

0.025MG;0.025MG;0.025MG;0.18MG;0.215MG;

0.25MG

0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;

0.25MG

0.035MG;0.25MG

ETHINYL ESTRADIOL; NORGESTREL

TABLET;ORAL-21

LO/OVRAL

WYETH PHARMS INC

LOW-OGESTREL-21

WATSON LABS

OGESTREL 0.5/50-21

WATSON LABS

OVRAL

WYETH PHARMS

TABLET;ORAL-28

OVRAL-28

WYETH PHARMS

ETHOPROPAZINE HYDROCHLORIDE

TABLET;ORAL

PARSIDOL

PARKE DAVIS

6-139(of 347)

A076393 001
Feb 04, 2010

A071042 001
Sep 24, 1991

N018354 002
Jan 11, 1982

N019004 002
Apr 04, 1984

N017716 001

N017576 001

N204426 001
Apr 19, 2013

N021065 002
Oct 15, 1999

N020130 001
Oct 09, 1996

N016749 001

N016852 001

N016723 001

N019653 001
Dec 29, 1989

N019697 002
Jul 03, 1992

A090479 001
Mar 09, 2011

A076626 001
Aug 17, 2006

A076627 001
Aug 17, 2006

0.03MG;0.3MG

N017612 001

0.03MG;0.3MG

A075288 001
Jul 28, 1999

0.05MG;0.5MG

A075406 001
Dec 15, 1999

0.05MG;0.5MG

N016672 001

0.05MG;0.5MG

N016806 001

10MG

50MG

100MG

N009078 003

N009078 006

N009078 008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-140(of 347)

DISCONTINUED DRUG PRODUCT LIST

ETHOTOIN

TABLET;ORAL

PEGANONE

RECORDATI RARE
ETHOXZOLAMIDE

TABLET;ORAL

CARDRASE

PHARMACIA AND UPJOHN
ETHAMIDE

ALLERGAN
ETHYLESTRENOL

ELIXIR;ORAL

MAXIBOLIN

ORGANON USA INC
TABLET;ORAL

MAXIBOLIN

ORGANON USA INC

500MG

N010841 003

62.5MG
125MG

N011047 002

N011047 001

125MG

N016144 001

2MG/5ML

N014006 002

2MG

N014005 002

ETHYNODIOL DIACETATE; MESTRANOL

TABLET;ORAL-20

OVULEN

GD SEARLE LLC
1MG;0.1MG
TABLET;ORAL-21

OVULEN-21

GD SEARLE LLC
1MG;0.1MG
TABLET;ORAL-28

OVULEN-28

GD SEARLE LLC
1MG;0.1MG
ETIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DURANEST

ASTRAZENECA
ETIDRONATE DISODIUM

INJECTABLE;INJECTION

DIDRONEL

MGI PHARMA INC
ETODOLAC

CAPSULE;ORAL

ETODOLAC

AAIPHARMA LLC
ANI PHARMS INC
MYLAN

SANDOZ

VINTAGE PHARMS LLC

WATSON LABS
LODINE

WYETH PHARMS INC
TABLET;ORAL

ETODOLAC

IVAX SUB TEVA PHARMS
LEHIGH VALLEY
MYLAN
PROSAM LABS
RANBAXY LABS LTD

N016029 002

N016029 003

N016705 001

0.5%
1%

N017751 003

N017751 005

50MG/ML

N019545 001 Apr 20, 1987

300MG
200MG
300MG
200MG
200MG
300MG
300MG
200MG
200MG
300MG
300MG
200MG
300MG
200MG
300MG

A074929
A074899
A074899
A074932
A075071
A074932
A075071
A074840
A074942
A074840
A074942
A074842
A074842
A074844
A074844

200MG
300MG

N018922 002 Jan 31, 1991

N018922 003 Jan 31, 1991

400MG
500MG
400MG
400MG
500MG
400MG
500MG
400MG
500MG

A074883
A074883
A074927
A075012
A075012
A074819
A074819
A075226
A075226

001
001
002
001
001
002
002
001
001
002
002
001
002
001
002

001
002
001
001
002
001
002
001
002

Jan
Jul
Jul
May
Sep
May
Sep
Aug
Sep
Aug
Sep
Jul
Jul
Dec
Dec

Feb
Nov
Oct
Sep
Sep
Feb
Apr
Nov
Nov

30,
08,
08,
16,
30,
16,
30,
29,
30,
29,
30,
17,
17,
23,
23,

28,
20,
30,
30,
30,
28,
28,
24,
24,

1998

1997

1997

1997

1998

1997

1998

1997

1997

1997

1997

1997

1997

1997

1997

1997

1998

1997

1998

1998

1997

1998

1998

1998

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-141(of 347)

DISCONTINUED DRUG PRODUCT LIST

ETODOLAC

TABLET;ORAL

ETODOLAC

SANDOZ
TEVA
VINTAGE PHARMS LLC
WATSON LABS

400MG
400MG
400MG
500MG
400MG
400MG
400MG
500MG

LODINE

WYETH PHARMS INC

400MG
500MG
TABLET, EXTENDED RELEASE;ORAL

ETODOLAC

ACTAVIS ELIZABETH
400MG
SANDOZ
400MG
500MG
600MG
WATSON LABS FLORIDA
400MG
500MG
LODINE XL

WYETH PHARMS INC
400MG
500MG
600MG
ETONOGESTREL

IMPLANT;IMPLANTATION

IMPLANON

ORGANON USA INC
ETOPOSIDE

CAPSULE;ORAL

VEPESID

DAVA PHARMS INC
INJECTABLE;INJECTION

ETOPOSIDE

HOSPIRA
PHARMACHEMIE BV
PIERRE FABRE
TEVA PARENTERAL
TEVA PHARMS USA
WATSON LABS
WATSON LABS INC
TOPOSAR

TEVA PARENTERAL
VEPESID

CORDEN PHARMA

EVANS BLUE

INJECTABLE;INJECTION

EVANS BLUE

PARKE DAVIS

001
001
001
002
001
001
001
002

Jul
Feb
Apr
Apr
Jun
Apr
Apr
Oct

11,
28,
23,
23,
27,
16,
16,
29,

1997

1997

1999

1999

1997

1997

1998

1998

N018922 004 Jul 29, 1993

N018922 005 Jun 28, 1996

A075696
A075943
A075943
A075943
A075829
A075829

001
001
002
003
001
002

Jul
Jul
Jul
Jul
Nov
Nov

31,
26,
26,
26,
30,
30,

2000

2002

2002

2002

2001

2001

N020584 001 Oct 25, 1996

N020584 003 Jan 20, 1998

N020584 002 Oct 25, 1996

68MG/IMPLANT

N021529 001 Jul 17, 2006

50MG
100MG

N019557 001 Dec 30, 1986

N019557 002 Dec 30, 1986

20MG/ML
20MG/ML
20MG/ML
20MG/ML
20MG/ML
20MG/ML
20MG/ML
20MG/ML

A074320
A074351
A074227
A074813
A074510
A074284
A074228
A074968

20MG/ML

A074166 001 Feb 27, 1995

20MG/ML

N018768 001 Nov 10, 1983

ETOPOSIDE PHOSPHATE

INJECTABLE;INJECTION

ETOPOPHOS PRESERVATIVE FREE

BRISTOL MYERS SQUIBB
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
ETRETINATE

CAPSULE;ORAL

TEGISON

ROCHE

A074839
A074846
A074847
A074847
A074841
A074892
A075069
A074892

001
001
001
001
001
001
001
001

Aug
Aug
Feb
Jul
Jun
Feb
Oct
Jan

30,
30,
22,
09,
29,
10,
15,
09,

1995

1995

1996

1997

1995

1994

1996

1998

N020906 001 Feb 27, 1998

N020906 002 Feb 27, 1998

10MG
25MG

N019369 001 Sep 30, 1986

N019369 002 Sep 30, 1986

0.5% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N008041 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-142(of 347)

DISCONTINUED DRUG PRODUCT LIST

EZETIMIBE

TABLET;ORAL

EZETIMIBE

GLENMARK PHARMS LTD

10MG

FAMOTIDINE

INJECTABLE;INJECTION

FAMOTIDINE

APOTEX INC
APOTHECON
EUROHLTH INTL SARL
HOSPIRA

10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
FAMOTIDINE PRESERVATIVE FREE

APOTEX INC
10MG/ML
APOTHECON
10MG/ML
HIKMA MAPLE
10MG/ML
HOSPIRA
10MG/ML
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)

APOTEX INC
10MG/ML
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

ABBVIE
0.4MG/ML
PEPCID

MERCK
10MG/ML
PEPCID PRESERVATIVE FREE

MERCK
10MG/ML
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

MERCK SHARP DOHME
0.4MG/ML
TABLET;ORAL

FAMOTIDINE

ACTAVIS ELIZABETH
20MG
40MG
APOTEX
10MG
MUTUAL PHARM
20MG
40MG
MYLAN PHARMS INC
20MG
40MG
SANDOZ
10MG
20MG
20MG
20MG
40MG
40MG
40MG
WATSON LABS
10MG
20MG
40MG
TABLET, CHEWABLE;ORAL

PEPCID AC

J AND J CONSUMER INC
10MG
TABLET, ORALLY DISINTEGRATING;ORAL

FLUXID

UCB INC
20MG
40MG
PEPCID RPD

MERCK
20MG
40MG

FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

FELODIPINE

WOCKHARDT LTD
2.5MG
5MG
10MG
PLENDIL

ASTRAZENECA
2.5MG
5MG
10MG

A078560 001 Jun 26, 2015

A075942
A075707
A075799
A075705
A075870
A075905

001
001
001
001
001
001

Aug
Apr
Apr
Apr
Nov
Nov

02,
16,
30,
16,
23,
23,

2002

2001

2002

2001

2001

2001

A076324
A075708
A075789
A075669

001
001
001
001

Nov
Apr
Apr
Apr

27,
16,
30,
16,

2002

2001

2002

2001

A076322 001 Nov 27, 2002

A075729 001 Dec 17, 2001

N019510 001 Nov 04, 1986

N019510 004 Nov 04, 1986

N020249 001 Feb 18, 1994

A075650
A075650
A075610
A075639
A075639
A075457
A075457
A076101
A075302
A075607
A075793
A075302
A075607
A075793
A075404
A075062
A075062

001
002
001
002
001
001
002
001
001
001
001
002
002
002
001
002
001

Sep
Sep
Mar
Dec
Dec
Apr
Apr
Oct
Apr
May
Apr
Apr
May
Apr
Nov
Apr
Apr

14,
14,
12,
12,
12,
18,
18,
21,
16,
10,
16,
16,
10,
16,
28,
16,
16,

2001

2001

2002

2001

2001

2001

2001

2002

2001

2001

2001

2001

2001

2001

2001

2001

2001

N020801 001 Sep 24, 1998

N021712 001 Sep 24, 2004

N021712 002 Sep 24, 2004

N020752 001 May 28, 1998

N020752 002 May 28, 1998

A091484 001 Aug 15, 2012

A091484 002 Aug 15, 2012

A091484 003 Aug 15, 2012

N019834 004 Sep 22, 1994

N019834 001 Jul 25, 1991

N019834 002 Jul 25, 1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-143(of 347)

DISCONTINUED DRUG PRODUCT LIST

FENOFIBRATE

CAPSULE;ORAL

ANTARA (MICRONIZED)

LUPIN ATLANTIS
LIPIDIL

ABBVIE
LIPOFEN

CIPHER PHARMS INC
TRICOR (MICRONIZED)

ABBVIE

TABLET;ORAL

FENOFIBRATE

MYLAN
TRICOR

ABBOTT
TRIGLIDE

SKYEPHARMA AG
FENOLDOPAM MESYLATE

INJECTABLE;INJECTION

FENOLDOPAM MESYLATE

LUITPOLD
TEVA PARENTERAL
FENOPROFEN CALCIUM

CAPSULE;ORAL

FENOPROFEN CALCIUM

AM THERAP
HALSEY
PAR PHARM
QUANTUM PHARMICS
SANDOZ
WARNER CHILCOTT
WATSON LABS

NALFON

XSPIRE
TABLET;ORAL

FENOPROFEN CALCIUM

ACTAVIS ELIZABETH
AM THERAP
DAVA PHARMS INC
HALSEY
IVAX SUB TEVA PHARMS
MUTUAL PHARM
PAR PHARM
QUANTUM PHARMICS
SANDOZ
USL PHARMA
WATSON LABS

NALFON

DISTA

87MG

N021695 002 Nov 30, 2004

100MG

N019304 001 Dec 31, 1993

100MG

N021612 002 Jan 11, 2006

67MG

134MG

200MG

N019304 002 Feb 09, 1998

N019304 003 Jun 30, 1999

N019304 004 Jun 30, 1999

107MG

A076520 002 Dec 29, 2005

54MG

160MG

N021203 001 Sep 04, 2001

N021203 003 Sep 04, 2001

50MG

N021350 001 May 07, 2005

EQ 10MG BASE/ML

EQ 10MG BASE/ML

A076656 001 Dec 01, 2003

A077826 001 Mar 07, 2007

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A072307
A072308
A072355
A072356
A072437
A072438
A072214
A071738
A072394
A072395
A072946
A072472
A072294
A072981
A072293
A072982

200MG
300MG
200MG
300MG
200MG
300MG
200MG
300MG
200MG
300MG
200MG
300MG
200MG
200MG
300MG
300MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

EQ 300MG BASE

N017604 002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A072274
A072309
A072326
A072357
A072557
A072902
A072429
A072194
A072396
A072362
A072165
A072407
A072602

600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

EQ 600MG BASE

FENTANYL

FILM, EXTENDED RELEASE;TRANSDERMAL

FENTANYL-100

NOVEN
100MCG/HR

FENTANYL-25

NOVEN
25MCG/HR

001
001
001
001
001
001
001
001
001
001
001
001
001

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Apr
Apr
Aug
Aug
Aug
Aug

22,
22,
17,
17,
22,
22,
17,
17,
17,
17,
30,
30,
17,
19,
17,
19,

1988

1988

1988

1988

1988

1988

1988

1988

1988

1988

1991

1991

1988

1991

1988

1991

May
Aug
Aug
Aug
Aug
Dec
Aug
Aug
Oct
Aug
Aug
Aug
Oct

02,
17,
17,
17,
29,
21,
17,
17,
17,
17,
17,
17,
11,

1988

1988

1988

1988

1988

1990

1988

1988

1988

1988

1988

1988

1988

N017710 001

A077775 004 Oct 16, 2009

A077775 001 Oct 16, 2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-144(of 347)

DISCONTINUED DRUG PRODUCT LIST

FENTANYL

FILM, EXTENDED RELEASE;TRANSDERMAL

FENTANYL-50
NOVEN
50MCG/HR
FENTANYL-75
NOVEN
75MCG/HR
FENTANYL CITRATE
FILM;BUCCAL
ONSOLIS
BIODELIVERY SCI INTL

EQ
EQ
EQ
EQ
EQ

0.2MG
0.4MG
0.6MG
0.8MG
1.2MG

A077775 002 Oct 16, 2009

A077775 003 Oct 16, 2009

BASE
BASE
BASE
BASE
BASE

INJECTABLE;INJECTION
FENTANYL CITRATE
ABBOTT

EQ 0.05MG BASE/ML
EQ 0.05MG BASE/ML
WATSON LABS
EQ 0.05MG BASE/ML
FENTANYL CITRATE PRESERVATIVE FREE
WATSON LABS INC
EQ 0.05MG BASE/ML
TABLET;BUCCAL, SUBLINGUAL
FENTANYL CITRATE
WATSON LABS
EQ 0.1MG BASE
EQ 0.2MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
FENTORA
CEPHALON
EQ 0.3MG BASE
TROCHE/LOZENGE;ORAL
FENTANYL
CEPHALON
EQ 0.1MG BASE
EQ 0.2MG BASE
EQ 0.3MG BASE
EQ 0.4MG BASE

N022266
N022266
N022266
N022266
N022266

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

16,
16,
16,
16,
16,

2009
2009
2009
2009
2009

A070636 001 Apr 30, 1990

A070637 001 Apr 30, 1990
A073488 001 Jun 30, 1992
A074917 001 Feb 03, 1998

A079075
A079075
A079075
A079075
A079075

001
002
003
004
005

Jan
Jan
Jan
Jan
Jan

07,
07,
07,
07,
07,

2011
2011
2011
2011
2011

N021947 006 Mar 02, 2007

N020195
N020195
N020195
N020195

007
001
002
003

Oct
Oct
Oct
Oct

30,
04,
04,
04,

1995
1993
1993
1993

FERRIC AMMONIUM CITRATE

FOR SOLUTION;ORAL
FERRISELTZ
OTSUKA

600MG/PACKET

N020292 001 Oct 14, 1997

FERROUS CITRATE, FE-59

INJECTABLE;INJECTION
FERROUS CITRATE FE 59
MALLINCKRODT

25uCi/ML

N016729 001

FERROUS SULFATE; FOLIC ACID

CAPSULE;ORAL
FOLVRON
LEDERLE

182MG;0.33MG

N006012 003

FERUMOXIDES
INJECTABLE;INJECTION
FERIDEX I.V.
AMAG PHARMS INC

EQ 11.2MG IRON/ML

N020416 001 Aug 30, 1996

FERUMOXSIL
SUSPENSION;ORAL
GASTROMARK
AMAG PHARMS INC

EQ 0.175MG IRON/ML

N020410 001 Dec 06, 1996

60MG

N020625 001 Jul 25, 1996

60MG

A076169 001 Jul 13, 2005

FEXOFENADINE HYDROCHLORIDE
CAPSULE;ORAL
ALLEGRA
SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE
BARR

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-145(of 347)

DISCONTINUED DRUG PRODUCT LIST

FIBRINOGEN, I-125

INJECTABLE;INJECTION

IBRIN

GE HEALTHCARE
154uCi/VIAL
RADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR

ABBOTT
140uCi/ML

N017879 001

N017787 001

FINASTERIDE
TABLET;ORAL
FINASTERIDE
IVAX SUB TEVA PHARMS

5MG

A076340 001 Jun 19, 2006

FLAVOXATE HYDROCHLORIDE
TABLET;ORAL
URISPAS
ORTHO MCNEIL JANSSEN

100MG

N016769 001

50MG
100MG
150MG
50MG
100MG
150MG

A079164
A079164
A079164
A076030
A076030
A076030

001
002
003
001
002
003

Jul
Jul
Jul
Oct
Oct
Oct

09,
09,
09,
28,
28,
28,

2009
2009
2009
2002
2002
2002

50MG
100MG
150MG
200MG

N018830
N018830
N018830
N018830

004
001
003
002

Aug
Oct
Jun
Oct

23,
31,
03,
31,

1988
1985
1988
1985

500MG/VIAL **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N016929 001

50MG/5ML
200MG/5ML

A076918 001 Dec 18, 2006

A076918 002 Dec 18, 2006

FLECAINIDE ACETATE
TABLET;ORAL
FLECAINIDE ACETATE
APOTEX INC

SANDOZ

TAMBOCOR
CNTY LINE PHARMS

FLOXURIDINE
INJECTABLE;INJECTION
FUDR
HOSPIRA

FLUCONAZOLE
FOR SUSPENSION;ORAL
FLUCONAZOLE
TARO PHARM INDS

INJECTABLE;INJECTION
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
MYLAN LABS LTD
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
MYLAN LABS LTD
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
TEVA PHARMS
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
TABLET;ORAL
FLUCONAZOLE
GEDEON RICHTER USA
50MG
100MG
150MG
200MG
MYLAN PHARMS INC
50MG
100MG
150MG
200MG
PLIVA
50MG
100MG
150MG
200MG
RANBAXY LABS LTD
50MG
100MG
150MG
200MG
ROXANE
50MG

A076888 001 Mar 25, 2005

A076888 002 Mar 25, 2005
A076617
A076617
A076889
A076889
A076837
A076837

001
002
001
002
001
002

Jul
Jul
Mar
Mar
Jan
Jan

29,
29,
25,
25,
13,
13,

2004
2004
2005
2005
2005
2005

A076432
A076432
A076432
A076432
A076042
A076042
A076042
A076042
A076424
A076424
A076424
A076424
A076386
A076386
A076386
A076386
A076213

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,

2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-146(of 347)

DISCONTINUED DRUG PRODUCT LIST

FLUCONAZOLE

TABLET;ORAL

FLUCONAZOLE

SANDOZ

FLUDARABINE PHOSPHATE

INJECTABLE;INJECTION

FLUDARA

GENZYME CORP

TABLET;ORAL

OFORTA

SANOFI AVENTIS US

FLUDEOXYGLUCOSE F-18

INJECTABLE;INJECTION

FLUDEOXYGLUCOSE F18

DOWNSTATE CLINCL

INJECTABLE;INTRAVENOUS

FLUDEOXYGLUCOSE F18

WEILL MEDCL COLL

FLUDROCORTISONE ACETATE

TABLET;ORAL

FLORINEF

CITRON PHARMA LLC

FLUMAZENIL

INJECTABLE;INJECTION

FLUMAZENIL

CLARIS PHARMASERVICE

TEVA PHARMS USA

ROMAZICON

HOFFMANN LA ROCHE

FLUMETHASONE PIVALATE

CREAM;TOPICAL

LOCORTEN

NOVARTIS

FLUNISOLIDE

AEROSOL, METERED;INHALATION

AEROBID

ROCHE PALO

SPRAY, METERED;NASAL

NASALIDE

IVAX RES

NASAREL

TEVA BRANDED PHARM

100MG

150MG

200MG

50MG

100MG

150MG

200MG

A076213
A076213
A076213
A076086
A076086
A076086
A076086

50MG/VIAL

N020038 001
Apr 18, 1991

10MG

N022273 001
Dec 18, 2008

4-40mCi/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

4-90mCi/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N020306 001
Aug 19, 1994

10-100mCi/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N021768 001
Aug 05, 2004

0.1MG

N010060 001

0.5MG/5ML (0.1MG/ML)

1MG/10ML (0.1MG/ML)

0.5MG/5ML (0.1MG/ML)

1MG/10ML (0.1MG/ML)

A076755
A076755
A076589
A076589

1MG/10ML (0.1MG/ML) **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

0.5MG/5ML (0.1MG/ML) **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N020073 001
Dec 20, 1991

0.03%

N016379 001

0.25MG/INH

N018340 001
Aug 17, 1984

0.025MG/SPRAY

N018148 001

0.029MG/SPRAY

N020409 001
Mar 08, 1995

002

003

004

001

002

003

004

Jul
Jul
Jul
Jul
Jul
Jul
Jul

29,
29,
29,
29,
29,
29,
29,

2004

2004

2004

2004

2004

2004

2004

N020306 002
Sep 25, 2001

002

001

002

001

Oct
Oct
Oct
Oct

12,
12,
12,
12,

2004

2004

2004

2004

N020073 002
Dec 20, 1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-147(of 347)

DISCONTINUED DRUG PRODUCT LIST

FLUOCINOLONE ACETONIDE

CREAM;TOPICAL

FLUOCET

ALPHARMA US PHARMS
FLUOCINOLONE ACETONIDE

ALPHARMA US PHARMS
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
TARO

USL PHARMA
FLUONID

ALLERGAN HERBERT
FLUOTREX

SAVAGE LABS
SYNALAR-HP

MEDIMETRIKS PHARMS
GEL;TOPICAL

FLUONID

ALLERGAN HERBERT
OINTMENT;TOPICAL

FLUOCINOLONE ACETONIDE

PHARMADERM
PHARMAFAIR
USL PHARMA
FLUONID

ALLERGAN HERBERT
FLUOTREX

SAVAGE LABS
SOLUTION;TOPICAL

FLUOCINOLONE ACETONIDE

ALPHARMA US PHARMS
BAUSCH AND LOMB
MORTON GROVE
PHARMADERM
PHARMAFAIR
FLUONID

ALLERGAN HERBERT
FLUOTREX

SAVAGE LABS

0.025%

A088360 001 Jan 16, 1984

0.01%
0.01%
0.025%
0.01%
0.025%
0.01%
0.025%
0.01%
0.01%
0.025%
0.01%
0.025%

A088361
A086810
A086811
A088047
A088045
A088499
A088506
A040035
A087102
A040042
A088757
A088756

0.025%

A087156 002 Sep 06, 1984

0.01%
0.025%

A088174 001 May 06, 1983

A088173 001 Mar 09, 1983

0.2%

N016161 002

0.025%

A087300 001 May 27, 1982

0.025%
0.025%
0.025%

A088046 001 Dec 16, 1982

A088507 001 Feb 27, 1984

A088742 001 Feb 08, 1985

0.025%

A087157 001 Sep 06, 1984

0.025%

A088172 001 Mar 09, 1983

0.01%
0.01%
0.01%
0.01%
0.01%

A087159
A040059
A088312
A088048
A088449

0.01%

A087158 001 Mar 17, 1983

0.01%

A088171 001 Mar 09, 1983

FLUOCINONIDE

CREAM;TOPICAL

FLUOCINONIDE

PERRIGO NEW YORK
0.05%
TARO
0.05%
FLUOCINONIDE EMULSIFIED BASE

G AND W LABS INC
0.05%
LIDEX

CNTY LINE PHARMS
0.05%
LIDEX-E

CNTY LINE PHARMS
0.05%
GEL;TOPICAL

LIDEX

CNTY LINE PHARMS
0.05% **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

OINTMENT;TOPICAL

LIDEX

CNTY LINE PHARMS
0.05% **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

001
001
001
001
001
001
001
001
001
001
001
001

001
001
001
001
001

Jan
Mar
Mar
Dec
Dec
Aug
Aug
Oct
Apr
Oct
Feb
Mar

Jun
Dec
Jan
Dec
Feb

16,
04,
04,
16,
16,
02,
02,
31,
27,
31,
11,
28,

16,
20,
27,
16,
08,

1984

1982

1982

1982

1982

1984

1984

1994

1982

1994

1985

1985

1982

1993

1984

1982

1984

A071790 001 Jul 13, 1988

A071500 001 Jun 10, 1987

A074204 001 Jun 13, 1995

N016908 002

N016908 003

N017373 001

N016909 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-148(of 347)

DISCONTINUED DRUG PRODUCT LIST

FLUOCINONIDE

SOLUTION;TOPICAL

FLUOCINONIDE

TARO
TEVA PHARMS

0.05%
0.05%

A072857 001 Aug 02, 1989

A072522 001 Sep 28, 1990

FLUORESCEIN SODIUM

INJECTABLE;INJECTION

FUNDUSCEIN-25

NOVARTIS

25%

N017869 001

0.025%

N011748 001

0.1%

A070185 001 Feb 27, 1986

FLUOROMETHOLONE

CREAM;TOPICAL

OXYLONE

PHARMACIA AND UPJOHN
SUSPENSION/DROPS;OPHTHALMIC

FLUOR-OP

NOVARTIS

FLUOROMETHOLONE ACETATE; TOBRAMYCIN

SUSPENSION/DROPS;OPHTHALMIC

TOBRASONE

ALCON
0.1%;0.3%

N050628 001 Jul 21, 1989

FLUOROMETHOLONE; SULFACETAMIDE SODIUM

SUSPENSION/DROPS;OPHTHALMIC

FML-S

ALLERGAN
0.1%;10%

N019525 001 Sep 29, 1989

FLUOROURACIL

INJECTABLE;INJECTION

ADRUCIL

PHARMACIA AND UPJOHN
TEVA PARENTERAL
FLUOROURACIL

ABIC
ABRAXIS PHARM

BEDFORD
EBEWE PHARMA
FRESENIUS KABI USA
MARCHAR
SMITH AND NEPHEW

SPECTRUM PHARMS
VALEANT
SOLUTION;TOPICAL

FLUOROPLEX

ELORAC
FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

FLUOXETINE

MUTUAL PHARMA
WATSON LABS
FLUOXETINE HYDROCHLORIDE

ANI PHARMS INC
BARR
CARLSBAD
CR DOUBLE CRANE
PAR PHARM
SANDOZ

50MG/ML
50MG/ML
50MG/ML
50MG/ML

A081222
N017959
A040023
A081225

001 Jun 28, 1991

001

001 Oct 18, 1991

001 Aug 28, 1991

50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
500MG/10ML (50MG/ML)
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
500MG/10ML (50MG/ML)

A088929
A089152
A089428
A089519
A089508
A040772
A040291
A040379
A087791
A088766
A088767
A089434
A087792
N012209

001
001
001
001
001
001
001
001
001
001
001
001
001
001

1%

N016765 001

Mar
Mar
Jan
Mar
Jan
Aug
Mar
Nov
Jan
Dec
Dec
Mar
Oct

04,
21,
12,
12,
26,
11,
24,
15,
18,
28,
28,
26,
13,

1986

1986

1987

1987

1988

2008

1999

2000

1983

1984

1984

1987

1982

EQ
EQ
EQ
EQ

10MG
20MG
10MG
20MG

BASE
BASE
BASE
BASE

A075787
A075787
A075662
A075662

001
002
001
002

Jan
Jan
Jan
Jan

29,
29,
29,
29,

2002

2002

2002

2002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

10MG
20MG
40MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
10MG
20MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A076287
A076287
A076251
A076022
A076022
A076165
A076165
A076922
A076922
A075807
A077469
A075807

001
002
001
001
002
001
002
001
002
001
001
002

May
May
May
Jan
Jan
Feb
Feb
Dec
Dec
Jan
Nov
Jan

20,
20,
18,
30,
30,
01,
01,
16,
16,
29,
17,
29,

2008

2008

2005

2002

2002

2002

2002

2004

2004

2002

2008

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-149(of 347)

DISCONTINUED DRUG PRODUCT LIST

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

FLUOXETINE HYDROCHLORIDE

WOCKHARDT LTD

PROZAC

ELI LILLY AND CO
SARAFEM

ELI LILLY AND CO

SOLUTION;ORAL

FLUOXETINE HYDROCHLORIDE

ACTAVIS MID ATLANTIC
APOTEX INC
HI TECH PHARMA
PROZAC

LILLY
TABLET;ORAL

FLUOXETINE HYDROCHLORIDE

BARR
IVAX SUB TEVA PHARMS
SANDOZ
PROZAC

LILLY
FLUOXYMESTERONE

TABLET;ORAL

ANDROID-F

VALEANT PHARM INTL
FLUOXYMESTERONE

VALEANT PHARM INTL
WATSON LABS

HALOTESTIN

PHARMACIA AND UPJOHN

ORA-TESTRYL

BRISTOL MYERS SQUIBB
FLUPHENAZINE DECANOATE

INJECTABLE;INJECTION

FLUPHENAZINE DECANOATE

HOSPIRA
MYLAN LABS LTD
TEVA PARENTERAL
PROLIXIN DECANOATE

BRISTOL MYERS SQUIBB
FLUPHENAZINE ENANTHATE

INJECTABLE;INJECTION

PROLIXIN ENANTHATE

APOTHECON

EQ
EQ
EQ
EQ

20MG
10MG
20MG
40MG

BASE
BASE
BASE
BASE

A077469
A078143
A078143
A078143

002
001
002
003

Nov
Jan
Jan
Jan

17,
16,
16,
16,

2008

2008

2008

2008

EQ 60MG BASE

N018936 004 Jun 15, 1999

EQ 10MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 20MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N018936 007 Jul 06, 2000

EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML

A075690 001 Jan 31, 2002

A075292 001 Feb 07, 2002

A075525 001 Jun 27, 2002

EQ 20MG BASE/5ML

N020101 001 Apr 24, 1991

EQ
EQ
EQ
EQ

A075810
A075865
A075865
A076024

10MG
10MG
40MG
10MG

BASE
BASE
BASE
BASE

N018936 008 Jul 06, 2000

001
001
003
001

Feb
Feb
Aug
Jan

01,
28,
30,
29,

2002

2002

2004

2002

EQ 10MG BASE
EQ 20MG BASE

N020974 001 Mar 09, 1999

N020974 002 Mar 09, 1999

10MG

A087196 001

10MG
2MG
5MG
10MG

A088221
A088260
A088265
A088309

2MG
5MG
10MG

N010611 002

N010611 006

N010611 010

2MG
5MG

N011359 001

N011359 002

25MG/ML
25MG/ML
25MG/ML

A074966 001 Apr 16, 1998

A075918 001 Aug 17, 2001

A074795 001 Sep 10, 1996

25MG/ML

N016727 001

25MG/ML

N016110 001

FLUPHENAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

FLUPHENAZINE HYDROCHLORIDE

TEVA PHARMS
5MG/ML
PERMITIL

SCHERING
5MG/ML
PROLIXIN

APOTHECON
5MG/ML

001
001
001
001

May
Dec
Dec
Dec

05,
06,
06,
06,

1983

1983

1983

1983

A073058 001 Aug 30, 1991

N016008 001

A070533 001 Nov 07, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-150(of 347)

DISCONTINUED DRUG PRODUCT LIST

FLUPHENAZINE HYDROCHLORIDE

ELIXIR;ORAL

FLUPHENAZINE HYDROCHLORIDE

ANI PHARMS INC
PROLIXIN

APOTHECON
INJECTABLE;INJECTION

PROLIXIN

APOTHECON
TABLET;ORAL

FLUPHENAZINE HYDROCHLORIDE

WATSON LABS

PERMITIL

SCHERING

2.5MG/5ML

A081310 001 Apr 29, 1993

2.5MG/5ML

N012145 003

2.5MG/ML

N011751 005

1MG
2.5MG
5MG
10MG

A088555
A088544
A088527
A088550

001
001
001
001

0.25MG
2.5MG
5MG
10MG

N012034
N012034
N012034
N012034

001

004

005

006

N011751
N011751
N011751
N011751

004

001

003

002

PROLIXIN

APOTHECON

1MG
2.5MG
5MG
10MG
TABLET, EXTENDED RELEASE;ORAL

PERMITIL

SCHERING
1MG
FLUPREDNISOLONE

TABLET;ORAL

ALPHADROL

PHARMACIA AND UPJOHN
FLURANDRENOLIDE

LOTION;TOPICAL

FLURANDRENOLIDE

ALPHARMA US PHARMS
OINTMENT;TOPICAL

CORDRAN

AQUA PHARMS

FLURAZEPAM HYDROCHLORIDE

HALSEY
HIKMA PHARMS LLC
MUTUAL PHARM
PAR PHARM
PUREPAC PHARM
SANDOZ
SUPERPHARM
USL PHARMA

18,
18,
18,
18,

1987

1987

1987

1987

N012419 004

1.5MG

N012259 002

0.05%

A087203 001 Apr 29, 1982

0.025% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N012806 004

FLURANDRENOLIDE; NEOMYCIN SULFATE

CREAM;TOPICAL

CORDRAN-N

LILLY
0.05%;EQ 3.5MG BASE/GM
OINTMENT;TOPICAL

CORDRAN-N

LILLY
0.05%;EQ 3.5MG BASE/GM
FLURAZEPAM HYDROCHLORIDE

CAPSULE;ORAL

DALMANE

VALEANT PHARM INTL

Dec
Dec
Dec
Dec

N050346 001

N050345 001

15MG
30MG

N016721 001

N016721 002

15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG

A071808
A071809
A071107
A071108
A070454
A070455
A070444
A070445
A071927
A071551
A071716
A071717
A071659
A071660
A070562
A070563

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jan
Jan
Dec
Dec
Aug
Aug
Mar
Mar
Sep
Sep
Jul
Jul
Aug
Aug
Jul
Jul

07,
07,
08,
08,
04,
04,
20,
20,
09,
09,
31,
31,
04,
04,
09,
09,

1988

1988

1986

1986

1986

1986

1986

1986

1987

1987

1991

1991

1988

1988

1987

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-151(of 347)

DISCONTINUED DRUG PRODUCT LIST

FLURAZEPAM HYDROCHLORIDE

CAPSULE;ORAL

FLURAZEPAM HYDROCHLORIDE

WARNER CHILCOTT
WATSON LABS

FLURBIPROFEN

TABLET;ORAL

ANSAID

PHARMACIA AND UPJOHN
FLURBIPROFEN

IVAX SUB TEVA PHARMS
PLIVA
SANDOZ
TEVA
THERAGEN
FLUTAMIDE

CAPSULE;ORAL

EULEXIN

SCHERING
FLUTAMIDE

SANDOZ
FLUTICASONE PROPIONATE

AEROSOL, METERED;INHALATION

FLOVENT

GLAXOSMITHKLINE

CREAM;TOPICAL

CUTIVATE

FOUGERA PHARMS

FLUTICASONE PROPIONATE

NESHER PHARMS
OINTMENT;TOPICAL

FLUTICASONE PROPIONATE

TARO PHARM INDS
POWDER;INHALATION

FLOVENT

GLAXOSMITHKLINE

FLUVOXAMINE MALEATE

TABLET;ORAL

FLUVOXAMINE MALEATE

ACTAVIS ELIZABETH

ANI PHARMS INC

MUTUAL PHARM

MYLAN
SANDOZ

SUN PHARM INDS INC

15MG
30MG
15MG
15MG
30MG
30MG

A071767
A071768
A071205
A072368
A071068
A072369

001
001
001
001
001
001

50MG
100MG

N018766 002 Oct 31, 1988

N018766 003 Oct 31, 1988

50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
100MG

A074411
A074411
A074647
A074647
A074448
A074448
A074405
A074405
A074560

125MG

N018554 001 Jan 27, 1989

125MG

A075818 001 Sep 18, 2001

0.044MG/INH
0.11MG/INH
0.22MG/INH

N020548 001 Mar 27, 1996

N020548 002 Mar 27, 1996

N020548 003 Mar 27, 1996

0.05% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N019958 001 Dec 18, 1990

0.05%

A076865 001 Sep 10, 2004

0.005%

A077145 001 Jun 14, 2005

0.044MG/INH
0.088MG/INH
0.22MG/INH

N020549 001 Nov 07, 1997

N020549 002 Nov 07, 1997

N020549 003 Nov 07, 1997

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG

A075901
A075901
A075901
A075898
A075898
A075898
A076125
A076125
A076125
A075950
A075950
A075887
A075887
A075887
A075900
A075900

001
002
001
002
001
002
002
001
002

001
002
003
001
002
003
001
002
003
001
002
001
002
003
001
002

Dec
Dec
Nov
Mar
Nov
Mar

May
May
Apr
Apr
Jul
Jul
May
May
May

Dec
Dec
Dec
Mar
Mar
Mar
Apr
Apr
Apr
Oct
Oct
Jan
Jan
Jan
Feb
Feb

04,
04,
25,
30,
25,
30,

31,
31,
01,
01,
28,
28,
24,
24,
16,

28,
28,
28,
12,
12,
12,
29,
29,
29,
15,
15,
05,
05,
05,
23,
23,

1987

1987

1986

1989

1986

1989

1995

1995

1997

1997

1995

1995

1995

1995

1997

2000

2000

2000

2001

2001

2001

2002

2002

2002

2001

2001

2001

2001

2001

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-152(of 347)

DISCONTINUED DRUG PRODUCT LIST

FLUVOXAMINE MALEATE

TABLET;ORAL

FLUVOXAMINE MALEATE

SYNTHON PHARMS

WATSON LABS

LUVOX

SOLVAY

FOLIC ACID

INJECTABLE;INJECTION

FOLIC ACID

BEN VENUE
FOLVITE

HIKMA (MAPLE)
TABLET;ORAL

FOLIC ACID

BARR
EVERYLIFE
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
JUBILANT CADISTA
LANNETT
LILLY
MK LABS
MUTUAL PHARM
NEXGEN PHARMA INC
PHARMERAL
PIONEER PHARMS
PUREPAC PHARM
SANDOZ
TABLICAPS
UDL
USL PHARMA
VALEANT PHARM INTL
VANGARD
VINTAGE PHARMS
WATSON LABS
WHITEWORTH TOWN PLSN
FOLICET

MISSION PHARMA
FOLVITE

HIKMA (MAPLE)

100MG
25MG
50MG
100MG
25MG
50MG
100MG

A075900
A075899
A075899
A075899
A075894
A075894
A075894

003
001
002
003
001
002
003

Feb
Jan
Jan
Jan
Apr
Apr
Apr

23,
17,
17,
17,
18,
18,
18,

2006

2001

2001

2001

2001

2001

2001

25MG
50MG
100MG
150MG

N020243
N020243
N020243
N020243

001
002
003
004

Dec
Dec
Dec
Dec

05,
05,
05,
05,

1994

1994

1994

1994

5MG/ML

A081066 001 Dec 29, 1993

5MG/ML

N005897 008

1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG

A089177
A080755
A083598
A080686
A083000
A040514
A080816
N006135
A083526
A040582
A084915
A084158
A088949
A080784
A084472
A083133
A088199
A087828
A080903
A088730
A086296
A083141
A085141
A080691

1MG

A087438 001

1MG

N005897 004

FOLLITROPIN ALFA/BETA

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

FOLLISTIM

ORGANON USA INC
75 IU/VIAL
150 IU/VIAL
INJECTABLE;SUBCUTANEOUS

FOLLISTIM AQ

ORGANON USA INC
150 IU/0.18ML
GONAL-F

EMD SERONO
37.5 IU/VIAL
37.5 IU/VIAL
75 IU/VIAL
150 IU/VIAL
150 IU/VIAL

001
001

001

001

001

001
001

003

001

001
001

001

001
001

001

002

001
001
001

001
001

001

002

002

Jan 08, 1986

Jun 14, 2005

Jul 18, 2005

Sep 13, 1985

Mar 29, 1983

May 13, 1982

Mar 23, 1984

N020582 001 Sep 29, 1997

N020582 002 Sep 29, 1997

N021211 003 Feb 11, 2004

N020378
N021765
N020378
N020378
N021765

003
001
001
002
003

May
Mar
Sep
Sep
Mar

25,
25,
29,
29,
25,

2000

2004

1997

1997

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-153(of 347)

DISCONTINUED DRUG PRODUCT LIST

FOMEPIZOLE

INJECTABLE;INJECTION

FOMEPIZOLE

MYLAN INSTITUTIONAL

1.5GM/1.5ML (1GM/ML)

A079033 001 Apr 07, 2009

FOMIVIRSEN SODIUM

INJECTABLE;INJECTION

VITRAVENE PRESERVATIVE FREE

NOVARTIS
6.6MG/ML

N020961 001 Aug 26, 1998

FORMOTEROL FUMARATE

POWDER;INHALATION

FORADIL CERTIHALER

NOVARTIS

0.0085MG/INH

N021592 001 Dec 15, 2006

FOSAPREPITANT DIMEGLUMINE

POWDER;INTRAVENOUS

EMEND

MERCK AND CO INC

EQ 115MG BASE/VIAL

N022023 001 Jan 25, 2008

10MG
20MG
40MG
10MG
20MG
40MG
10MG
10MG
20MG
20MG
40MG
40MG

A076580
A076580
A076580
A076188
A076188
A076188
A076987
A077531
A076987
A077531
A076987
A077531

10MG
20MG
40MG

N019915 002 May 16, 1991

N019915 003 May 16, 1991

N019915 004 Mar 28, 1995

FOSINOPRIL SODIUM

TABLET;ORAL

FOSINOPRIL SODIUM

RANBAXY LABS LTD

SANDOZ

WATSON LABS

MONOPRIL

BRISTOL MYERS SQUIBB

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET;ORAL

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

MYLAN
10MG;12.5MG
20MG;12.5MG
TEVA
10MG;12.5MG
20MG;12.5MG
WATSON LABS
10MG;12.5MG
20MG;12.5MG
MONOPRIL-HCT

BRISTOL MYERS SQUIBB
10MG;12.5MG
20MG;12.5MG

A077705
A077705
A076945
A076945
A077144
A077144

001
002
003
001
002
003
001
001
002
002
003
003

001
002
001
002
001
002

Apr
Apr
Apr
Oct
Oct
Oct
Dec
Aug
Dec
Aug
Dec
Aug

Aug
Aug
Jul
Jul
Aug
Aug

23,
23,
23,
08,
08,
08,
23,
31,
23,
31,
23,
31,

14,
14,
05,
05,
16,
16,

2004

2004

2004

2004

2004

2004

2004

2006

2004

2006

2004

2006

2006

2006

2006

2006

2005

2005

N020286 002 Nov 30, 1994

N020286 001 Nov 30, 1994

FOSPHENYTOIN SODIUM

INJECTABLE;INJECTION

FOSPHENYTOIN SODIUM

APOTEX INC
TEVA PHARMS USA

EQ 50MG PHENYTOIN NA/ML

EQ 50MG PHENYTOIN NA/ML

A078126 001 Aug 06, 2007

A076886 001 Aug 06, 2007

FOSPROPOFOL DISODIUM

SOLUTION;INTRAVENOUS

LUSEDRA

EISAI INC

1050MG/30ML (35MG/ML)

N022244 001 Dec 12, 2008

50MG/15ML

N011323 002

100MG

N011270 002

FURAZOLIDONE

SUSPENSION;ORAL

FUROXONE

SHIRE
TABLET;ORAL

FUROXONE

SHIRE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-154(of 347)

DISCONTINUED DRUG PRODUCT LIST

FUROSEMIDE

INJECTABLE;INJECTION

FUROSEMIDE

ABRAXIS PHARM
ASTRAZENECA
HIKMA MAPLE
HOSPIRA

IGI LABS INC

INTL MEDICATION
MARSAM PHARMS LLC
ORGANON USA INC
SMITH AND NEPHEW
WARNER CHILCOTT
WATSON LABS
WYETH AYERST
LASIX

SANOFI AVENTIS US
SOLUTION;ORAL

LASIX

SANOFI AVENTIS US
TABLET;ORAL

FUROSEMIDE

DAVA PHARMS INC

INTL MEDICATION
KALAPHARM
MUTUAL PHARM

SANDOZ
SUPERPHARM
WARNER CHILCOTT

WATSON LABS

GABAPENTIN

CAPSULE;ORAL

GABAPENTIN

IVAX SUB TEVA PHARMS

MUTUAL PHARM

SANDOZ

WATSON LABS

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

10MG/ML

N018507
N019036
A070014
A071439
N018267
A070578
A072080
A074337
A070095
A070096
N018025
A074017
A070017
A070023
A070078
N018420
A070019
A070604
N018670

001
001
001
001
001

001
001
001
001
001
001

001
001
001
001
001
001
001
001

Jul
Aug
Sep
Sep

30,
13,
09,
14,

1982

1984

1985

1990

Jul
Aug
Oct
Sep
Sep

08,
13,
31,
09,
09,

1987

1991

1994

1985

1985

Jun
Dec
Feb
Feb
Feb
Sep
Jan
Jul

30,
15,
05,
05,
26,
22,
02,
20,

1994

1986

1986

1986

1982

1986

1987

1982

10MG/ML

N016363 001

10MG/ML

N017688 001

20MG

40MG

80MG

20MG

40MG

20MG

40MG

20MG

40MG

80MG

40MG

20MG

40MG

20MG

40MG

80MG

20MG

20MG

20MG

20MG

40MG

40MG

40MG

80MG

80MG

N018415
N018415
N018415
N018753
N018753
N018868
N018868
A070043
N018790
A070100
N018750
N018370
N018370
N018419
N018419
N018419
A070412
A070449
A071379
N018369
A070413
A070450
N018369
A070528
A071594

001
002
003
001
002
001
002
001
001
001
002
002
001
001
002
003
001
001
001
001
001
001
002
001
001

Jul
Jul
Nov
Feb
Feb
Jun
Jun
Sep
Nov
Jan
Jul
Jun
Feb
Jan
Jan
Nov
Feb
Nov
Jan
May
Feb
Nov
May
Jan
Feb

27,
27,
26,
28,
28,
28,
28,
26,
29,
26,
30,
26,
10,
31,
31,
13,
26,
22,
02,
14,
26,
22,
14,
07,
09,

1982

1982

1984

1984

1984

1983

1983

1985

1983

1988

1984

1984

1983

1983

1983

1984

1986

1985

1987

1982

1986

1985

1982

1986

1988

100MG

300MG

400MG

100MG

300MG

400MG

100MG

100MG

300MG

300MG

400MG

400MG

100MG

300MG

400MG

A075477
A075477
A075477
A076537
A076537
A076537
A075428
A075539
A075428
A075539
A075428
A075539
A075485
A075485
A075485

001
002
003
001
002
003
001
001
002
002
003
003
003
002
001

Mar
Mar
Mar
Jun
Jun
Jun
Jan
Apr
Jan
Apr
Jan
Apr
May
May
May

23,
23,
23,
30,
30,
30,
24,
06,
24,
06,
24,
06,
11,
11,
11,

2005

2005

2005

2005

2005

2005

2006

2005

2006

2005

2006

2005

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-155(of 347)

DISCONTINUED DRUG PRODUCT LIST

GABAPENTIN

TABLET;ORAL

GABAPENTIN

HIKMA PHARMS
RANBAXY
SANDOZ

TEVA
GADODIAMIDE

INJECTABLE;INJECTION

OMNISCAN

GE HEALTHCARE
GALANTAMINE HYDROBROMIDE

TABLET;ORAL

GALANTAMINE HYDROBROMIDE

ACTAVIS ELIZABETH

YABAO PHARM

GALLAMINE TRIETHIODIDE

INJECTABLE;INJECTION

FLAXEDIL

DAVIS AND GECK
GALLIUM CITRATE GA-67

INJECTABLE;INJECTION

GALLIUM CITRATE GA 67

GE HEALTHCARE
NEOSCAN

GE HEALTHCARE
GALLIUM NITRATE

INJECTABLE;INJECTION

GANITE

CHAPTER 7 TRUSTEE
GANCICLOVIR

CAPSULE;ORAL

CYTOVENE

ROCHE PALO

GANCICLOVIR

RANBAXY LABS LTD
IMPLANT;IMPLANTATION

VITRASERT

BAUSCH AND LOMB

600MG
800MG
600MG
800MG
600MG
600MG
800MG
800MG
600MG
800MG

A078782
A078782
A076605
A076605
A076120
A076877
A076120
A076877
A075827
A075827

14.35GM/50ML (287MG/ML)

N022066 001 Sep 05, 2007

EQ
EQ
EQ
EQ
EQ
EQ

A077585
A077585
A077585
A077604
A077604
A077604

4MG BASE
8MG BASE
12MG BASE
4MG BASE
8MG BASE
12MG BASE

001
002
001
002
001
001
002
002
001
002

001
002
003
001
002
003

Jul
Jul
Sep
Sep
Jan
Jul
Jan
Jul
Dec
Dec

Sep
Sep
Sep
Feb
Feb
Feb

21,
21,
14,
14,
27,
06,
27,
06,
15,
15,

15,
15,
15,
06,
06,
06,

2011

2011

2005

2005

2006

2006

2006

2006

2004

2004

2009

2009

2009

2009

2009

2009

20MG/ML
100MG/ML

N007842 001

N007842 002

1mCi/ML

N017700 001

2mCi/ML

N017655 001

25MG/ML

N019961 002 Jan 17, 1991

250MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

500MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N020460 001 Dec 22, 1994

250MG
500MG

A076457 001 Jun 27, 2003

A076457 002 Jun 27, 2003

N020460 002 Dec 12, 1997

4.5MG

N020569 001 Mar 04, 1996

GANCICLOVIR SODIUM

INJECTABLE;INJECTION

GANCICLOVIR SODIUM

EUROHLTH INTL SARL

EQ 500MG BASE/VIAL

A076222 001 Jul 16, 2003

GATIFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

GATIFLOXACIN

APOTEX INC

0.3%

A079084 001 Aug 19, 2011

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6-156(of 347)

DISCONTINUED DRUG PRODUCT LIST

GEFITINIB

TABLET;ORAL

IRESSA

ASTRAZENECA
GEMFIBROZIL

CAPSULE;ORAL

GEMFIBROZIL

MYLAN
PUREPAC PHARM
LOPID

PFIZER PHARMS
TABLET;ORAL

GEMFIBROZIL

MYLAN
PUREPAC PHARM
SANDOZ
WATSON LABS
GEMTUZUMAB OZOGAMICIN

INJECTABLE;INJECTION

MYLOTARG

WYETH PHARMS INC
GENTAMICIN SULFATE

CREAM;TOPICAL

GARAMYCIN

SCHERING
GENTAFAIR

PHARMAFAIR
GENTAMICIN SULFATE

ALPHARMA US PHARMS
G AND W LABS INC
PHARMADERM
INJECTABLE;INJECTION

APOGEN

KING PHARMS
BRISTAGEN

BRISTOL
GARAMYCIN

SCHERING

GENTAFAIR

PHARMAFAIR
GENTAMICIN

INTL MEDICATION

GENTAMICIN SULFATE

ABBOTT

FRESENIUS KABI USA

HIKMA MAPLE
KALAPHARM
PHARM SPEC
SOLOPAK
TEVA PARENTERAL
WATSON LABS

250MG

N021399 001 May 05, 2003

300MG

300MG

A073466 001 Jan 25, 1993

A072929 001 Jan 29, 1993

200MG

300MG

N018422 001

N018422 002

600MG

600MG

600MG

600MG

600MG

A074452
A074360
A074615
A074156
A074442

5MG/VIAL

N021174 001 May 17, 2000

EQ 0.1% BASE

A060462 001

EQ 0.1% BASE

A062458 001 Sep 01, 1983

EQ 0.1% BASE

EQ 0.1% BASE

EQ 1MG BASE/GM

A062471 001 Sep 27, 1983

A064056 001 Apr 29, 1994

A062530 001 Jul 05, 1984

EQ 10MG BASE/ML

EQ 40MG BASE/ML

A062289 001

A062289 002

EQ 40MG BASE/ML

A062288 001

EQ 1MG BASE/ML

EQ 10MG BASE/ML

EQ 40MG BASE/ML

A061716 002

A061739 001

A061716 001

EQ 40MG BASE/ML

A062493 001 Aug 28, 1985

EQ 1MG BASE/ML

EQ 40MG BASE/ML

EQ 100MG BASE/100ML

A062325 003 Jun 23, 1982

A062325 001

A062325 004 Jun 23, 1982

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A062413
A062413
A062413
A062413
A062413
A062413
A062413
A062413
A062413
A062413
A062356
A062356
A062251
A062251
A062354
A062340
A062507
A062507
A063149
A063106
A062318

1.2MG BASE/ML

1.4MG BASE/ML

1.6MG BASE/ML

1.8MG BASE/ML

2MG BASE/ML

60MG BASE/100ML

70MG BASE/100ML

80MG BASE/100ML

90MG BASE/100ML

100MG BASE/100ML

10MG BASE/ML

40MG BASE/ML

10MG BASE/ML

40MG BASE/ML

40MG BASE/ML

40MG BASE/ML

10MG BASE/ML

40MG BASE/ML

10MG BASE/ML

40MG BASE/ML

10MG BASE/ML

001
001
001
001
001

001
002
003
004
005
006
007
008
009
010
001
002
002

001

001
001
001
002
001
002
002

Feb
Aug
Sep
Oct
Apr

16,
31,
29,
24,
28,

1995

1994

1995

1994

1995

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Mar
Mar

11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
04,
04,

1983

1983

1983

1983

1983

1983

1983

1983

1983

1983

1982

1982

Apr
Mar
Jun
Jun
Nov
Nov

05,
28,
06,
06,
21,
21,

1982

1983

1985

1985

1991

1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-157(of 347)

DISCONTINUED DRUG PRODUCT LIST

GENTAMICIN SULFATE

INJECTABLE;INJECTION

GENTAMICIN SULFATE

EQ 40MG BASE/ML
EQ 10MG BASE/ML
EQ 40MG BASE/ML
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
EQ 0.8MG BASE/ML
EQ 1.2MG BASE/ML
EQ 1.4MG BASE/ML
EQ 1.6MG BASE/ML
EQ 1.8MG BASE/ML
EQ 2MG BASE/ML
EQ 2.4MG BASE/ML
EQ 40MG BASE/100ML
EQ 60MG BASE/100ML
EQ 70MG BASE/100ML
EQ 80MG BASE/100ML
EQ 90MG BASE/100ML
EQ 100MG BASE/100ML
EQ 120MG BASE/100ML
BAXTER HLTHCARE
EQ 0.8MG BASE/ML
EQ 2.4MG BASE/ML
EQ 40MG BASE/100ML
EQ 60MG BASE/100ML
HOSPIRA
EQ 1.2MG BASE/ML
EQ 1.4MG BASE/ML
EQ 1.4MG BASE/ML
EQ 1.6MG BASE/ML
EQ 1.8MG BASE/ML
EQ 1.8MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 60MG BASE/100ML
EQ 60MG BASE/100ML
EQ 70MG BASE/100ML
EQ 70MG BASE/100ML
EQ 80MG BASE/100ML
EQ 90MG BASE/100ML
EQ 90MG BASE/100ML
EQ 100MG BASE/100ML
U-GENCIN

PHARMACIA AND UPJOHN
EQ 10MG BASE/ML
EQ 40MG BASE/ML
INJECTABLE;INTRATHECAL

GARAMYCIN

SCHERING
EQ 2MG BASE/ML
OINTMENT;OPHTHALMIC

GARAMYCIN

SCHERING
EQ 0.3% BASE
GENTACIDIN

NOVARTIS
EQ 0.3% BASE
GENTAFAIR

PHARMAFAIR
EQ 3MG BASE/GM
OINTMENT;TOPICAL

GARAMYCIN

SCHERING
EQ 0.1% BASE
GENTAFAIR

PHARMAFAIR
EQ 0.1% BASE
GENTAMICIN SULFATE

ALPHARMA US PHARMS
EQ 0.1% BASE
G AND W LABS INC
EQ 0.1% BASE
PHARMADERM
EQ 0.1% BASE
SOLUTION/DROPS;OPHTHALMIC

GARAMYCIN

SCHERING
EQ 0.3% BASE
GENTACIDIN

NOVARTIS
EQ 0.3% BASE
GENTAFAIR

PHARMAFAIR
EQ 0.3% BASE
GENTAMICIN SULFATE

ALCON PHARMS LTD
EQ 0.3% BASE
WYETH AYERST

A062318 001

A062264 001

A062264 002

A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062373
A062373
A062373
A062373
A062588
A062414
A062588
A062588
A062414
A062588
A062414
A062588
A062414
A062588
A062414
A062588
A062588
A062414
A062588
A062588

001
002
003
004
005
006
007
008
009
010
011
012
013
014
001
010
003
004
001
002
002
003
004
004
005
005
006
006
007
007
008
009
009
010

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Jan
Aug
Jan
Jan
Aug
Jan
Aug
Jan
Aug
Jan
Aug
Jan
Jan
Aug
Jan
Jan

28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
07,
07,
07,
07,
06,
15,
06,
06,
15,
06,
15,
06,
15,
06,
15,
06,
06,
15,
06,
06,

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1982

1982

1982

1982

1986

1983

1986

1986

1983

1986

1983

1986

1983

1986

1983

1986

1986

1983

1986

1986

A062248 001

A062248 002

N050505 001

N050425 001

A062501 001 Jul 26, 1984

A062443 001 May 26, 1983

A060463 001

A062444 001 May 26, 1983

A062496 001 Mar 14, 1984

A064054 001 Apr 29, 1994

A062534 001 Oct 10, 1984

N050039 002

A062480 001 Mar 30, 1984

A062440 001 May 03, 1983

A062523 001 Nov 25, 1985

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DISCONTINUED DRUG PRODUCT LIST

GENTAMICIN SULFATE

SOLUTION/DROPS;OPHTHALMIC

GENTAMICIN SULFATE

PACO

EQ 3MG BASE/ML

A062932 001 Nov 07, 1988

GENTIAN VIOLET

SUPPOSITORY;VAGINAL

GVS

SAVAGE LABS
TAMPON;VAGINAL

GENAPAX

KEY PHARMS

0.4%

A083513 001

5MG

A085017 001

GLATIRAMER ACETATE

FOR SOLUTION;SUBCUTANEOUS

COPAXONE

TEVA PHARMS USA

20MG/VIAL

N020622 001 Dec 20, 1996

1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
3MG
6MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG

A077274
A077274
A077274
A078952
A078952
A078952
A077486
A077486
A077486
A077366
A077366
A076875
A076875
A076875
A076875
A077280
A077280
A077280

GLIMEPIRIDE

TABLET;ORAL

GLIMEPIRIDE

COREPHARMA

HIKMA PHARMS

MYLAN

RANBAXY
RANBAXY LABS LTD

WATSON LABS

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDARYL

SB PHARMCO
1MG;4MG **Federal Register
determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

2MG;4MG **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

2MG;8MG **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

4MG;4MG **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

4MG;8MG **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

GLIPIZIDE

TABLET;ORAL

GLIPIZIDE

ANI PHARMS INC
BARR LABS INC
SANDOZ
VINTAGE PHARMS LLC
WATSON LABS

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

001
002
003
001
002
003
001
002
003
001
002
001
002
003
004
001
002
003

Oct
Oct
Oct
Aug
Aug
Aug
Feb
Feb
Feb
Oct
Oct
Oct
Oct
Oct
Oct
Feb
Feb
Feb

06,
06,
06,
01,
01,
01,
10,
10,
10,
06,
06,
06,
06,
06,
06,
03,
03,
03,

2005

2005

2005

2013

2013

2013

2006

2006

2006

2005

2005

2005

2005

2005

2005

2006

2006

2006

N021700 001 Nov 23, 2005

or

N021700 002 Nov 23, 2005

or

N021700 004 Mar 30, 2007

or

N021700 003 Nov 23, 2005

or

N021700 005 Mar 30, 2007

or

A074387
A074387
A074619
A074619
A074542
A074542
A074378
A074378
A074370
A074370

001
002
001
002
001
002
001
002
001
002

Mar
Mar
Apr
Apr
Jun
Jun
Nov
Nov
Nov
Nov

04,
04,
04,
04,
20,
20,
28,
28,
22,
22,

1996

1996

1997

1997

1995

1995

1994

1994

1994

1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-159(of 347)

DISCONTINUED DRUG PRODUCT LIST

GLIPIZIDE

TABLET;ORAL

GLUCOTROL

PFIZER

2.5MG

N017783 003 May 11, 1993

GLIPIZIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

METAGLIP
BRISTOL MYERS SQUIBB
2.5MG;250MG
2.5MG;500MG
5MG;500MG

N021460 001 Oct 21, 2002

N021460 002 Oct 21, 2002
N021460 003 Oct 21, 2002

GLUCAGON HYDROCHLORIDE
INJECTABLE;INJECTION
GLUCAGON
LILLY

EQ 1MG BASE/VIAL **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 10MG BASE/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N012122 001

500MG

N009519 008

250MG
500MG

N009519 002
N009519 005

250MG
500MG
250MG
500MG
500MG
500MG
500MG
500MG
500MG

A089458
A089459
A083475
A085571
A083234
A085171
A087297
A084362
A085763

1.5MG
3MG
6MG

A075947 001 Nov 14, 2002

A075947 002 Nov 14, 2002
A075947 003 Nov 14, 2002

1.5MG
3MG
1.5MG
3MG
6MG

A075174
A075174
N020055
N020055
N020055

4.5MG

N020051 003 Sep 24, 1993

1.25MG
2.5MG
5MG

N017498 001 May 01, 1984

N017498 002 May 01, 1984
N017498 003 May 01, 1984

GLUTETHIMIDE
CAPSULE;ORAL
DORIDEN
SANOFI AVENTIS US
TABLET;ORAL
DORIDEN
SANOFI AVENTIS US
GLUTETHIMIDE
HALSEY
LANNETT
SANDOZ
UCB INC
VITARINE
WATSON LABS
GLYBURIDE
TABLET;ORAL
GLYBURIDE
ACTAVIS ELIZABETH

GLYBURIDE (MICRONIZED)
SANDOZ
SANOFI AVENTIS US

GLYNASE
PHARMACIA AND UPJOHN
MICRONASE
PHARMACIA AND UPJOHN

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLUCOVANCE

BRISTOL MYERS SQUIBB
1.25MG;250MG
GLYBURIDE AND METFORMIN HYDROCHLORIDE

TEVA
1.25MG;250MG
2.5MG;500MG
5MG;500MG

N012122 002

001 Oct 10, 1986

001 Oct 10, 1986
001
001
002
001
001
001
001

001
002
001
002
003

Jun
Jun
Apr
Apr
Mar

22,
22,
17,
17,
08,

1998
1998
1992
1992
2000

N021178 001 Jul 31, 2000

A076821 001 Jan 27, 2005

A076821 002 Jan 27, 2005

A076821 003 Jan 27, 2005

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6-160(of 347)

DISCONTINUED DRUG PRODUCT LIST

GLYCINE

SOLUTION;IRRIGATION

GLYCINE 1.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE

1.5GM/100ML

HOSPIRA

1.5GM/100ML

GLYCOPYRROLATE

INJECTABLE;INJECTION

GLYCOPYRROLATE

ABRAXIS PHARM

HOSPIRA

TEVA PARENTERAL

WATSON LABS

ROBINUL

ROBINS AH

TABLET;ORAL

GLYCOPYRROLATE

COREPHARMA

HIKMA PHARMS LLC

WATSON LABS

GONADORELIN ACETATE

INJECTABLE;INJECTION

LUTREPULSE KIT

FERRING

GONADORELIN HYDROCHLORIDE

INJECTABLE;INJECTION

FACTREL

HIKMA (MAPLE)

GONADOTROPIN, CHORIONIC

INJECTABLE;INJECTION

A.P.L.

FERRING

CHORIONIC GONADOTROPIN

BEL MAR

FERRING

FRESENIUS KABI USA

FOLLUTEIN

BRISTOL MYERS SQUIBB

N018522 001
Feb 19, 1982

N017633 001

0.2MG/ML

0.2MG/ML

0.2MG/ML

0.2MG/ML

A088475
A089393
A081169
A086947

0.2MG/ML

N014764 001

1MG

2MG

1MG

2MG

1MG

1MG

2MG

2MG

2MG

A040568
A040568
A040836
A040836
A085562
A086902
A085563
A086178
A086900

0.8MG/VIAL

3.2MG/VIAL

N019687 001
Oct 10, 1989

N019687 002
Oct 10, 1989

EQ 0.1MG BASE/VIAL

EQ 0.2MG BASE/VIAL

EQ 0.5MG BASE/VIAL

N018123 001
Sep 30, 1982

N018123 002
Sep 30, 1982

N018123 003
Sep 30, 1982

5,000 UNITS/VIAL

10,000 UNITS/VIAL

20,000 UNITS/VIAL

N017055 001

N017055 002

N017055 003

5,000 UNITS/VIAL

10,000 UNITS/VIAL

2,000 UNITS/VIAL

2,000 UNITS/VIAL

5,000 UNITS/VIAL

15,000 UNITS/VIAL

20,000 UNITS/VIAL

5,000 UNITS/VIAL

15,000 UNITS/VIAL

20,000 UNITS/VIAL

N017054
N017054
N017016
N017016
N017016
N017016
N017016
N017067
N017067
N017067

10,000 UNITS/VIAL

N017056 001

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OPHTHALMIC

NEO-POLYCIN

DOW PHARM
0.025MG/ML;EQ 1.75MG BASE/ML;10,000

UNITS/ML

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

IPHARM
0.025MG/ML;EQ 1.75MG BASE/ML;10,000

UNITS/ML

WATSON LABS
0.025MG/ML;EQ 1.75MG BASE/ML;10,000

UNITS/ML

NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN

PHARMAFAIR
0.025MG/ML;EQ 1.75MG BASE/ML;10,000

UNITS/ML

001

001

001

001

001

002

001

002

001

001

001

001

001

Jun
Jun
Sep
Jun

12,
15,
10,
24,

1984

1988

1991

1983

Dec
Dec
Mar
Mar

22,
22,
05,
05,

2004

2004

2009

2009

001

002

009
Dec 27, 1984

011
Feb 16, 1990

006

010
Feb 15, 1985

004

001

004

003

A060427 001

A062818 001
Oct 11, 1988

A062788 001
Jun 11, 1987

A062383 001
Aug 31, 1982

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6-161(of 347)

DISCONTINUED DRUG PRODUCT LIST

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION

GRANISETRON HYDROCHLORIDE

APOTEX INC
CLARIS PHARMASERVICE

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

SANDOZ INC
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

TEVA PHARMS USA

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

KYTRIL

ROCHE

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

EQ 3MG BASE/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

SOLUTION;ORAL

GRANISOL

PEDIATRX

EQ 2MG BASE/10ML

KYTRIL

ROCHE

EQ 2MG BASE/10ML

TABLET;ORAL

GRANISETRON HYDROCHLORIDE

BARR

EQ 1MG BASE

KYTRIL

ROCHE

EQ 1MG BASE **Federal Register

determination that product was not

withdrawn or discontinued for safety or

efficacy reasons**

EQ 2MG BASE **Federal Register

determination that product was not

withdrawn or discontinued for safety or

efficacy reasons**

GREPAFLOXACIN HYDROCHLORIDE

TABLET;ORAL

RAXAR

OTSUKA

EQ 200MG BASE

EQ 400MG BASE

EQ 600MG BASE

GRISEOFULVIN, MICROCRYSTALLINE

CAPSULE;ORAL

GRISACTIN

WYETH AYERST

125MG

250MG

SUSPENSION;ORAL

GRIFULVIN V

JOHNSON AND JOHNSON

125MG/5ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

TABLET;ORAL

FULVICIN-U/F

ELORAC

250MG

500MG

GRIFULVIN V

J AND J

125MG

250MG

500MG

VALEANT LUXEMBOURG

125MG

250MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

A078197
A078198
A078198
A078808

001

001

002

001

Dec
Jun
Jun
Apr

31,
30,
30,
29,

2007

2008

2008

2008

A077165 001
Dec 31, 2007

N020239 003
Sep 17, 2004

N020239 004
Mar 11, 1994

N020239 001
Dec 29, 1993

N020239 002
Mar 11, 1994

A078334 001
Feb 28, 2008

N021238 001
Jun 27, 2001

A078221 001
Dec 31, 2007

N020305 001
Mar 16, 1995

N020305 002
Jun 15, 1998

N020695 001
Nov 06, 1997

N020695 002
May 14, 1998

N020695 003
May 14, 1998

N050051 002

N050051 001

N050448 001

A060569 002

A060569 001

A060618
A060618
A060618
A062279
A062279

001

002

003

001

002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-162(of 347)

DISCONTINUED DRUG PRODUCT LIST

GRISEOFULVIN, MICROCRYSTALLINE

TABLET;ORAL

GRIFULVIN V

reasons**

GRISACTIN

WYETH AYERST
GRISEOFULVIN, MICROSIZE

SUSPENSION;ORAL

GRIFULVIN V

VALEANT LUXEMBOURG

TABLET;ORAL

GRIFULVIN V

VALEANT LUXEMBOURG

500MG

A060212 001

125MG/5ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

A062483 001 Jan 26, 1984

500MG

A062279 003

GRISEOFULVIN, ULTRAMICROCRYSTALLINE

TABLET;ORAL

FULVICIN P/G

ELORAC
125MG
250MG
FULVICIN P/G 165

ELORAC
165MG
FULVICIN P/G 330

ELORAC
330MG
GRISACTIN ULTRA

WYETH AYERST
125MG
165MG
250MG
330MG
ULTRAGRIS-165

PLIVA
165MG
ULTRAGRIS-330

PLIVA
330MG
GUANABENZ ACETATE

TABLET;ORAL

GUANABENZ ACETATE

ANI PHARMS INC
SANDOZ
WATSON LABS
WYTENSIN

WYETH AYERST

GUANADREL SULFATE

TABLET;ORAL

HYLOREL

PHARMACIA AND UPJOHN
GUANETHIDINE MONOSULFATE

TABLET;ORAL

GUANETHIDINE MONOSULFATE

WATSON LABS
ISMELIN

NOVARTIS

EQ
EQ
EQ
EQ
EQ
EQ

4MG
8MG
4MG
8MG
4MG
8MG

A061996 001

A061996 002

A061996 003 Apr 06, 1982

A061996 004 Apr 06, 1982

A062178
A062438
A062178
A062438

001

001 Nov 17, 1983

002

002 Nov 17, 1983

A062645 001 Jun 30, 1992

A062646 001 Jun 30, 1992

BASE
BASE
BASE
BASE
BASE
BASE

A074267
A074267
A074517
A074517
A074025
A074025

001
002
001
002
001
002

Jun
Jun
Sep
Sep
Feb
Feb

01,
01,
30,
30,
28,
28,

1994

1994

1998

1998

1994

1994

EQ 4MG BASE
EQ 8MG BASE
EQ 16MG BASE

N018587 001 Sep 07, 1982

N018587 002 Sep 07, 1982

N018587 003 Sep 07, 1982

10MG
25MG

N018104 001 Dec 29, 1982

N018104 002 Dec 29, 1982

EQ 10MG SULFATE
EQ 25MG SULFATE

A086113 001 Mar 26, 1985

A086114 001 Mar 26, 1985

EQ 10MG SULFATE
EQ 25MG SULFATE

N012329 001

N012329 002

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ESIMIL

NOVARTIS
10MG;25MG

N013553 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-163(of 347)

DISCONTINUED DRUG PRODUCT LIST

GUANFACINE HYDROCHLORIDE

TABLET;ORAL

GUANFACINE HYDROCHLORIDE

WATSON LABS
TENEX

PROMIUS PHARMA
HALAZEPAM

TABLET;ORAL

PAXIPAM

SCHERING

EQ 1MG BASE
EQ 2MG BASE

A074762 001 Jun 25, 1997

A074762 002 Jun 25, 1997

EQ 3MG BASE

N019032 003 Nov 07, 1988

20MG
40MG

N017736 003

N017736 004

0.025%

N017818 001

0.1%

N018234 001

HALCINONIDE

CREAM;TOPICAL

HALOG

WESTWOOD SQUIBB
HALOG-E

RANBAXY
OINTMENT;TOPICAL

HALOG

BRISTOL MYERS SQUIBB
SOLUTION;TOPICAL

HALOG

RANBAXY

0.025%

N018125 001

0.1%

N017823 001

HALOBETASOL PROPIONATE

OINTMENT;TOPICAL

HALOBETASOL PROPIONATE

FOUGERA PHARMS
G AND W LABS INC

0.05%
0.05%

A076903 001 Dec 16, 2004

A077109 001 Jun 14, 2005

HALOFANTRINE HYDROCHLORIDE

TABLET;ORAL

HALFAN

GLAXOSMITHKLINE

250MG

N020250 001 Jul 24, 1992

0.5MG
1MG
2MG
5MG
10MG
20MG

N015921
N015921
N015921
N015921
N015921
N015921

1MG

N017079 001

0.5MG
1MG
5MG
10MG
20MG
0.5MG
1MG
2MG
5MG
10MG
20MG
0.5MG
1MG
2MG
5MG
10MG
20MG
0.5MG
1MG
2MG
5MG
10MG
20MG
20MG
0.5MG

A071128
A071129
A071131
A071132
A071133
A071216
A071217
A071218
A071219
A071220
A071221
A072727
A072728
A072729
A072730
A072731
A072732
A071156
A071157
A071172
A071212
A071173
A071177
A071328
A071071

HALOPERIDOL

TABLET;ORAL

HALDOL

ORTHO MCNEIL

HALDOL SOLUTAB

ORTHO MCNEIL PHARM
HALOPERIDOL

CYCLE PHARMS LTD

DURAMED PHARMS BARR

LEDERLE

MUTUAL PHARM

PAR PHARM
PUREPAC PHARM

001

002

003

004

005

006 Feb 02, 1982

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Feb
Feb
Feb
May
May
Dec
Dec
Dec
Dec
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Jan
Jan
Jan
Jan
Jan
Jan
Jul
Nov

17,
17,
17,
12,
12,
04,
04,
04,
04,
07,
07,
19,
19,
19,
19,
19,
19,
02,
02,
02,
07,
07,
07,
20,
03,

1987

1987

1987

1987

1987

1986

1986

1986

1986

1987

1987

1989

1989

1989

1989

1989

1989

1987

1987

1987

1988

1988

1988

1987

1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-164(of 347)

DISCONTINUED DRUG PRODUCT LIST

HALOPERIDOL

TABLET;ORAL

HALOPERIDOL

QUANTUM PHARMICS

ROXANE
ROYCE LABS

SCS

VINTAGE

WATSON LABS

HALOPERIDOL DECANOATE

INJECTABLE;INJECTION

HALOPERIDOL DECANOATE

HOSPIRA
SANDOZ
HALOPERIDOL LACTATE

CONCENTRATE;ORAL

HALDOL

ORTHO MCNEIL
HALOPERIDOL

ALPHARMA
MORTON GROVE
SCS
TEVA
HALOPERIDOL INTENSOL

CYCLE PHARMS LTD
INJECTABLE;INJECTION

HALOPERIDOL

ABRAXIS PHARM
CLARIS PHARMASERVICE
MARSAM PHARMS LLC
SANDOZ
SMITH AND NEPHEW
SOLOPAK

1MG

2MG

5MG

10MG

20MG

0.5MG

1MG

2MG

5MG

2MG

0.5MG

1MG

2MG

5MG

10MG

20MG

0.5MG

1MG

2MG

5MG

10MG

20MG

0.5MG

1MG

2MG

5MG

10MG

0.5MG

0.5MG

1MG

1MG

2MG

2MG

5MG

5MG

10MG

10MG

20MG

20MG

A071072
A071073
A071074
A071075
A071076
A071255
A071269
A071256
A071257
A071130
A071722
A071723
A071724
A071725
A072121
A072122
A070720
A070721
A070722
A070723
A070724
A070725
A071233
A071234
A071235
A071236
A071237
A070981
A071571
A070982
A071572
A070983
A071573
A070984
A071374
A071375
A072113
A071376
A072353

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Nov
Nov
Nov
Aug
Aug
Feb
Feb
Feb
Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Sep
Nov
Nov
Nov
Nov
Jul
Mar
Jun
Mar
Jun
Mar
Jun
Mar
Jun
Jun
Aug
Jun
Aug

03,
03,
03,
04,
04,
17,
17,
17,
17,
17,
24,
24,
24,
24,
24,
24,
10,
10,
10,
10,
10,
24,
03,
03,
03,
03,
20,
06,
03,
06,
03,
06,
03,
06,
03,
03,
27,
03,
27,

1986

1986

1986

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1986

1986

1986

1986

1986

1986

1986

1986

1986

1986

1987

1987

1988

1987

1988

1987

1988

1987

1988

1988

1991

1988

1991

EQ
EQ
EQ
EQ

A075176
A075176
A076463
A076463

001
002
001
002

Feb
Feb
Jun
Jun

09,
09,
24,
24,

2000

2000

2005

2005

Apr
Mar
Jun
Aug

11,
07,
10,
25,

1986

1986

1986

1987

50MG BASE/ML

100MG BASE/ML

50MG BASE/ML

100MG BASE/ML

EQ 2MG BASE/ML

N015922 001

EQ
EQ
EQ
EQ

A070318
A070710
A070726
A071015

2MG
2MG
2MG
2MG

BASE/ML

BASE/ML

BASE/ML

BASE/ML

001
001
001
001

EQ 2MG BASE/ML

A072045 001 Apr 12, 1988

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A071187
A076791
A076828
A072516
A072517
A076464
A070802
A070800
A070801

5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

BASE/ML

001
001
001
001
001
001
001
001
001

Jan
Aug
Aug
Feb
Feb
Sep
Dec
Dec
Dec

20,
25,
25,
25,
25,
29,
14,
14,
14,

1987

2004

2004

1993

1993

2004

1987

1987

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-165(of 347)

DISCONTINUED DRUG PRODUCT LIST

HALOPERIDOL LACTATE

INJECTABLE;INJECTION

HALOPERIDOL

WATSON LABS

SOLUTION;ORAL

HALOPERIDOL LACTATE

ACTAVIS MID ATLANTIC

HALOPROGIN

CREAM;TOPICAL

HALOTEX

WESTWOOD SQUIBB

SOLUTION;TOPICAL

HALOTEX

WESTWOOD SQUIBB

HALOTHANE

LIQUID;INHALATION

FLUOTHANE

WYETH AYERST

HALOTHANE

BH

HALOCARBON

HOSPIRA

HEPARIN CALCIUM

INJECTABLE;INJECTION

CALCIPARINE

SANOFI AVENTIS US

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN LOCK FLUSH

HOSPIRA

INTL MEDICATION

LUITPOLD

PARKE DAVIS

SMITH AND NEPHEW

SOLOPAK

HEPARIN SODIUM

ABRAXIS PHARM

AKORN

CHAMBERLIN PARENTERL

DELL LABS

EUROHLTH INTL SARL

EQ
EQ
EQ
EQ

5MG
5MG
5MG
5MG

BASE/ML

BASE/ML

BASE/ML

BASE/ML

A070864
A070713
A070714
A070744

001
001
001
001

Dec
May
May
May

14,
17,
17,
17,

1987

1988

1988

1988

EQ 1MG BASE/ML

A074536 001 Nov 02, 1995

1%

N016942 001

1%

N016943 001

99.99%

N011338 001

99.99%

99.99%

99.99%

A084977 001

A080810 001

A083254 001

25,000 UNITS/ML

N018237 001

100 UNITS/ML

10 UNITS/ML

500 UNITS/ML

10 UNITS/ML

100 UNITS/ML

10 UNITS/ML

10 UNITS/ML

10 UNITS/ML

10 UNITS/ML

10 UNITS/ML

100 UNITS/ML

100 UNITS/ML

100 UNITS/ML

100 UNITS/ML

10 UNITS/ML

10 UNITS/ML

100 UNITS/ML

100 UNITS/ML

N005264
A086357
A086357
A089063
A089064
N017346
A087904
A087958
A088458
A088580
A087906
A087959
A088460
A088581
A087903
A088457
A087905
A088459

010

001

002

001
001
006

001
001
001
001
001
001
001
001
001
001
001
001

1,000 UNITS/ML

1,000 UNITS/ML

5,000 UNITS/ML

10,000 UNITS/ML

1,000 UNITS/ML

5,000 UNITS/ML

10,000 UNITS/ML

20,000 UNITS/ML

40,000 UNITS/ML

1,000 UNITS/ML

5,000 UNITS/ML

10,000 UNITS/ML

20,000 UNITS/ML

1,000 UNITS/ML

5,000 UNITS/ML

10,000 UNITS/ML

20,000 UNITS/ML

40,000 UNITS/ML

1,000 UNITS/ML

N017033
N017979
N017979
N017979
N017486
N017486
N017486
N017486
N017486
N017130
N017130
N017130
N017130
N017540
N017540
N017540
N017540
N017540
N017007

001

001

003

002

001

002

003

004

005

001

002

003

004

001

002

003

004

005

001

Oct 09, 1985

Oct 09, 1985

Apr
Apr
Jul
Oct
Apr
Apr
Jul
Oct
Apr
Oct
Apr
Jul

20,
20,
26,
25,
20,
20,
26,
25,
20,
25,
20,
26,

1983

1983

1984

1984

1983

1983

1984

1984

1983

1984

1983

1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

6-166(of 347)

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM

2,500 UNITS/ML
N017007
5,000 UNITS/ML
N017007
5,000 UNITS/0.5ML
N017007
5,000 UNITS/0.5ML
N017037
7,500 UNITS/ML
N017007
10,000 UNITS/ML
N017007
15,000 UNITS/ML
N017007
20,000 UNITS/ML
N017007
FRESENIUS KABI USA
1,000 UNITS/ML
N017651
5,000 UNITS/ML
N017029
10,000 UNITS/ML
N017651
20,000 UNITS/ML
N017651
HOSPIRA
2,500 UNITS/ML
A088099
10,000 UNITS/ML
A040095
LILLY
1,000 UNITS/ML
N005521
10,000 UNITS/ML
N005521
20,000 UNITS/ML
N005521
LUITPOLD
1,000 UNITS/ML
A087452
ORGANON USA INC
1,000 UNITS/ML
N000552
5,000 UNITS/ML
N000552
10,000 UNITS/ML
N000552
PARKE DAVIS
1,000 UNITS/ML
N017346
5,000 UNITS/ML
N017346
7,500 UNITS/ML
N017346
10,000 UNITS/ML
N017346
20,000 UNITS/ML
N017346
PHARM SPEC
1,000 UNITS/ML
N017780
5,000 UNITS/ML
N017780
10,000 UNITS/ML
N017780
20,000 UNITS/ML
N017780
40,000 UNITS/ML
N017780
PHARMACIA AND UPJOHN 1,000 UNITS/ML
N004570
5,000 UNITS/ML
N004570
10,000 UNITS/ML
N004570
SMITH AND NEPHEW
1,000 UNITS/ML
A088239
SOLOPAK
1,000 UNITS/ML
A087043
5,000 UNITS/ML
A087077
5,000 UNITS/0.5ML
A087395
10,000 UNITS/ML
A087107
10,000 UNITS/0.5ML
A087363
WATSON LABS
1,000 UNITS/ML
N017064
2,500 UNITS/ML
N017064
3,000 UNITS/ML
N017064
4,000 UNITS/ML
N017064
5,000 UNITS/ML
N017064
6,000 UNITS/ML
N017064
7,500 UNITS/ML
N017064
10,000 UNITS/ML
N017064
20,000 UNITS/ML
N017064
40,000 UNITS/ML
N017064
WATSON LABS INC
1,000 UNITS/ML
A040007
1,000 UNITS/ML
A040008
HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

MCGAW
200 UNITS/100ML
N019130
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
200 UNITS/100ML
N019042
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
2,000 UNITS/100ML
N018814
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%

HOSPIRA
10,000 UNITS/100ML
N018911
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%

HOSPIRA
10,000 UNITS/100ML
N018911
10,000 UNITS/100ML
N018916
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%

HOSPIRA
10,000 UNITS/100ML
N018911
10,000 UNITS/100ML
N018916
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5%

HOSPIRA
5,000 UNITS/100ML
N018911

007

002

010

013
003

004

005

006

005

002

003

008

001
001
001

002

004

001
008

009

010

001

002

003

004

005

001

002

003

004

005

001

002

003

001
001

001

001

001

001

002

015

016

017

003

018

019

004

005

006

001
001

Apr 07, 1986

Apr 28, 1983

Jul 26, 1996

Oct 31, 1983

Jul 26, 1984

Jun 07, 1996

Oct 10, 1995

001 Dec 31, 1984

001 Mar 29, 1985

002 Jul 09, 1985

006 Jan 30, 1985

001 Jan 30, 1985

005 Jan 31, 1984

003 Jan 30, 1985

002 Jan 31, 1984

007 Jan 30, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
5,000 UNITS/100ML
N019802
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%

HOSPIRA
5,000 UNITS/100ML
N018911
5,000 UNITS/100ML
N018916
HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

MCGAW
200 UNITS/100ML
N019130
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
200 UNITS/100ML

N019042
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4,000 UNITS/100ML

N018814
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
5,000 UNITS/100ML

N018814
10,000 UNITS/100ML

N018814
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%

HOSPIRA
5,000 UNITS/100ML

N018911
10,000 UNITS/100ML

N018911
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
5,000 UNITS/100ML

N019134
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
5,000 UNITS/100ML
N019802
10,000 UNITS/100ML
N019802
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%

HOSPIRA
5,000 UNITS/100ML
N018911
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
5,000 UNITS/100ML
N019135
5,000 UNITS/100ML
N019802
HOSPIRA
5,000 UNITS/100ML
N018916
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARE
500 UNITS/100ML
N018609
HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

MCGAW
1,000 UNITS/100ML
N019130
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%

HOSPIRA
100 UNITS/ML
N018911
100 UNITS/ML
N018916
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%

HOSPIRA
1,000 UNITS/100ML
N018916
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
1,000 UNITS/100ML

N019042
HEPARIN SODIUM PRESERVATIVE FREE

HOSPIRA

2,000 UNITS/ML

N005264
2,500 UNITS/ML

N005264
PHARMA SERVE NY

1,000 UNITS/ML

A086129
WATSON LABS INC

1,000 UNITS/ML

A089464
LIPO-HEPIN

3M

1,000 UNITS/0.5ML

N017027
1,000 UNITS/ML

N017027
5,000 UNITS/0.5ML

N017027
5,000 UNITS/ML

N017027
7,500 UNITS/0.5ML

N017027
10,000 UNITS/0.5ML

N017027
10,000 UNITS/ML

N017027
15,000 UNITS/0.5ML

N017027
20,000 UNITS/0.5ML

N017027
20,000 UNITS/ML

N017027
40,000 UNITS/ML

N017027
LIQUAEMIN LOCK FLUSH

ORGANON USA INC

100 UNITS/ML

N000552
LIQUAEMIN SODIUM

ORGANON USA INC

1,000 UNITS/ML

N000552
5,000 UNITS/ML

N000552
10,000 UNITS/ML

N000552
20,000 UNITS/ML

N000552
40,000 UNITS/ML

N000552
LIQUAEMIN SODIUM PRESERVATIVE FREE

ORGANON USA INC
1,000 UNITS/ML

N000552
5,000 UNITS/ML

N000552
10,000 UNITS/ML

N000552
PANHEPRIN

HOSPIRA
1,000 UNITS/ML

N005264

6-167(of 347)

001 Jul 20, 1992

005 Jan 30, 1985

003 Jan 31, 1984

003 Dec 31, 1984

002 Mar 29, 1985

001 Oct 31, 1983

003 Jul 09, 1985

004 Jul 02, 1987

009 Jan 30, 1985

008 Jan 30, 1985

001 Mar 29, 1985

005 Jul 20, 1992

002 Jul 20, 1992

004 Jan 30, 1985

001 Mar 29, 1985

003 Jul 20, 1992

009 Jan 31, 1984

003 Apr 28, 1982

002 Dec 31, 1984

002 Jan 30, 1985

004 Jan 31, 1984

001 Jan 31, 1984

004 Mar 29, 1985

013 Apr 07, 1986

014 Apr 07, 1986

001

001 Jun 03, 1986

001

006

002

008

010

003

009

011

004

007

005

007

004

003

005

001

002

011 Apr 11, 1986

012 Apr 11, 1986

013 Apr 11, 1986

004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-168(of 347)

DISCONTINUED DRUG PRODUCT LIST

HEPARIN SODIUM

INJECTABLE;INJECTION

PANHEPRIN

SODIUM HEPARIN

ABRAXIS PHARM

BAXTER HLTHCARE
HETACILLIN

FOR SUSPENSION;ORAL

VERSAPEN

BRISTOL

HETACILLIN POTASSIUM

CAPSULE;ORAL

VERSAPEN-K

BRISTOL

5,000 UNITS/ML

10,000 UNITS/ML

20,000 UNITS/ML

40,000 UNITS/ML

N005264
N005264
N005264
N005264

006

007

008

009

5,000 UNITS/ML

10,000 UNITS/ML

20,000 UNITS/ML

1,000 UNITS/ML

N017033
N017033
N017033
N017036

002

003

004

001 Mar 04, 1988

EQ
EQ
EQ
EQ

A061398
N050060
N050060
A061398

001

001

003

002

112.5MG AMPICIL/ML

112.5MG AMPICIL/5ML

112.5MG AMPICIL/ML

225MG AMPICIL/5ML

EQ 225MG AMPICIL

EQ 450MG AMPICIL

HEXACHLOROPHENE

AEROSOL;TOPICAL

SEPTISOL

VESTAL LABS
0.23%

TURGEX

XTTRIUM
3%

EMULSION;TOPICAL

HEXA-GERM

HUNTINGTON LABS
3%

PHISOHEX

SANOFI AVENTIS US
3%

SOY-DOME

BAYER PHARMS
3%

TURGEX

XTTRIUM
3%

SOAP;TOPICAL

GAMOPHEN

ARBROOK
2%

SOLUTION;TOPICAL

DIAL

DIAL
0.25%

GERMA-MEDICA

HUNTINGTON LABS
1%

GERMA-MEDICA "MG"

HUNTINGTON LABS
0.25%

SEPTI-SOFT

CALGON
0.25%

SEPTISOL

VESTAL LABS
0.25%

SPONGE;TOPICAL

E-Z SCRUB

BECTON DICKINSON
450MG

HEXASCRUB

PROF DSPLS
3%

PHISO-SCRUB

SANOFI AVENTIS US
3%

SCRUBTEAM SURGICAL SPONGEBRUSH

3M
330MG

HEXAFLUORENIUM BROMIDE

INJECTABLE;INJECTION

MYLAXEN

MEDPOINTE PHARM HLC

20MG/ML

A061396 001

A061396 002

N017424 001

N018375 001

N017411 001

N008402 001

N017405 001

N019055 001 Nov 30, 1984

N006270 003

N017421 002

N017412 001

N017412 002

N017460 001

N017423 001

N017452 001

N018363 001

N017446 001

N017413 001

N009789 003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-169(of 347)

DISCONTINUED DRUG PRODUCT LIST

HEXOCYCLIUM METHYLSULFATE
TABLET;ORAL
TRAL
ABBVIE

25MG

N010599 001

HEXYLCAINE HYDROCHLORIDE
SOLUTION;TOPICAL
CYCLAINE
MERCK

5%

N008472 001

EQ 0.1MG BASE/ML
EQ 0.2MG BASE/ML
EQ 1MG BASE/ML

N000734 003
N000734 002
N000734 001

EQ 0.2MG BASE/ML
EQ 0.5MG BASE/ML
EQ 1MG BASE/ML

N019836 001 Dec 24, 1991

N019836 002 Dec 24, 1991
N019836 003 Dec 24, 1991

10MG

A086308 001

5MG

A086309 001

3MG

A086310 001

HISTAMINE PHOSPHATE
INJECTABLE;INJECTION
HISTAMINE PHOSPHATE
LILLY

HISTRELIN ACETATE
INJECTABLE;INJECTION
SUPPRELIN
SHIRE

HOMATROPINE METHYLBROMIDE
TABLET;ORAL
HOMAPIN-10
MISSION PHARMA
HOMAPIN-5
MISSION PHARMA
TABLET, CHEWABLE;ORAL
EQUIPIN
MISSION PHARMA

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP;ORAL

HYCODAN

ENDO PHARMS
1.5MG/5ML;5MG/5ML
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

IVAX SUB TEVA PHARMS
1.5MG/5ML;5MG/5ML
HYDROPANE

HALSEY
1.5MG/5ML;5MG/5ML
TABLET;ORAL

HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

ACTAVIS ELIZABETH
1.5MG;5MG
HYCODAN

ENDO PHARMS
1.5MG;5MG
HYALURONIDASE

INJECTABLE;INJECTION

HYDASE

AKORN INC
VITRASE

BAUSCH AND LOMB
WYDASE

BAXTER HLTHCARE

HYDRALAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

APRESOLINE

NOVARTIS
HYDRALAZINE HYDROCHLORIDE

ABRAXIS PHARM
SMITH AND NEPHEW
SOLOPAK
TEVA PARENTERAL

N005213 002 Jul 26, 1988

A040285 001 Jul 19, 1999

A088066 001 Jun 28, 1985

A040295 001 Dec 01, 2000

N005213 001 Jul 26, 1988

150 UNITS/ML

N021716 001 Oct 25, 2005

6,200 UNITS/VIAL

N021640 001 May 05, 2004

150 UNITS/ML
150 UNITS/VIAL **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

1,500 UNITS/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N006343 002

N006343 006

20MG/ML

N008303 003

20MG/ML
20MG/ML
20MG/ML
20MG/ML

A089532
A088518
A088517
A040373

N006343 005

001
001
001
001

Aug
Apr
Aug
Feb

11,
20,
22,
23,

1987

1984

1985

2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-170(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL

APRESOLINE

NOVARTIS

DRALZINE

TEVA

HYDRALAZINE HYDROCHLORIDE

ACTAVIS ELIZABETH

ASCOT

HALSEY

HERITAGE PHARMS INC

IMPAX LABS

IVAX SUB TEVA PHARMS

MUTUAL PHARM

PUREPAC PHARM

QUANTUM PHARMICS

SANDOZ

SUPERPHARM

TG UNITED LABS

USL PHARMA

VANGARD

VITARINE

WATSON LABS

WEST WARD

10MG

25MG

50MG

100MG

N008303
N008303
N008303
N008303

25MG

A084301 001

25MG

50MG

25MG

50MG

10MG

25MG

50MG

100MG

10MG

25MG

50MG

100MG

25MG

50MG

10MG

25MG

50MG

100MG

10MG

10MG

25MG

25MG

50MG

50MG

100MG

25MG

50MG

10MG

25MG

50MG

100MG

10MG

25MG

50MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

100MG

25MG

50MG

25MG

50MG

25MG

25MG

25MG

50MG

50MG

25MG

50MG

A088560
A088649
A088310
A088311
A089218
A089130
A089222
A089178
A040858
A040858
A040858
A040858
A084922
A084923
A084443
A084437
A084469
A084581
A088728
A089359
A084106
A089258
A084107
A089259
A088729
A088177
A088178
A088671
A088657
A088652
A088686
A083241
A083560
A083561
A085088
A088787
A088788
A088789
A088846
A088847
A088848
A088849
A087780
A087751
A087712
A087908
A086088
A084504
A085532
A084503
A085533
A088240
A088241

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE;ORAL
APRESAZIDE
NOVARTIS
25MG;25MG
50MG;50MG
100MG;50MG
HYDRA-ZIDE
PAR PHARM
100MG;50MG

004

001

002

005

001
001
001
001
001
001
001
001
001
002
003
004
001

001

001

001

002

001

001
001
002

001
002

001
001
001
001
001
001
001
001
001

001

001

001

001
001
001
001
001
001
001
001
001
001

001
001

001

002
001

002
001
001

Oct
Oct
Dec
Dec
Jan
Jan
Jan
Jan
Feb
Feb
Feb
Feb

04,
18,
19,
19,
22,
15,
22,
15,
26,
26,
26,
26,

1984

1984

1984

1984

1986

1986

1986

1986

2010

2010

2010

2010

Apr 11, 1985

Jul 25, 1986

May 05, 1986

May
Apr
Jul
Aug
May
Jun
May
May

05,
11,
29,
15,
01,
15,
08,
01,

1986

1985

1983

1983

1984

1984

1984

1984

Aug
Aug
Aug
Feb
Feb
Feb
Feb
Mar
Mar

28,
28,
28,
26,
26,
26,
26,
29,
29,

1984

1984

1984

1985

1985

1985

1985

1982

1982

May 07, 1982

May 24, 1982

May 25, 1982

May 27, 1983

May 27, 1983

A084735 001
A084810 001
A084811 001
A088961 001 Oct 21, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-171(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

SOLVAY
25MG;25MG

50MG;50MG

100MG;50MG

SUPERPHARM
25MG;25MG

50MG;50MG

WATSON LABS
25MG;25MG

50MG;50MG

100MG;50MG

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50

IVAX PHARMS
100MG;50MG

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25

IVAX PHARMS
25MG;25MG

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50

IVAX PHARMS
50MG;50MG

TABLET;ORAL

APRESOLINE-ESIDRIX

NOVARTIS
25MG;15MG

HYDRALAZINE AND HYDROCHLORTHIAZIDE

WATSON LABS
25MG;15MG

HYDROCHLOROTHIAZIDE W/ HYDRALAZINE

WATSON LABS
25MG;15MG

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

TABLET;ORAL

CAM-AP-ES

TG UNITED LABS
25MG;15MG;0.1MG

HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE

IVAX SUB TEVA PHARMS
25MG;15MG;0.1MG

HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE

MYLAN
25MG;15MG;0.1MG

HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE

WATSON LABS
25MG;15MG;0.1MG

HYDRAP-ES

SANDOZ
25MG;15MG;0.1MG

HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE

WATSON LABS
25MG;15MG;0.1MG

HYDROSERPINE PLUS (R-H-H)

IVAX SUB TEVA PHARMS

25MG;15MG;0.1MG

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

MUTUAL PHARM
25MG;15MG;0.1MG

SOLVAY
25MG;15MG;0.1MG

WATSON LABS
25MG;15MG;0.1MG

25MG;15MG;0.1MG

RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE

LEDERLE
25MG;15MG;0.1MG

SER-A-GEN

SOLVAY
25MG;15MG;0.1MG

SER-AP-ES

NOVARTIS
25MG;15MG;0.1MG

UNIPRES

SOLVAY
25MG;15MG;0.1MG

25MG;15MG;0.1MG

HYDRALAZINE HYDROCHLORIDE; RESERPINE

TABLET;ORAL

DRALSERP

SANDOZ
25MG;0.1MG

SERPASIL-APRESOLINE

NOVARTIS
25MG;0.1MG

50MG;0.2MG

HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDROCHLOROTHIAZIDE

HIKMA INTL PHARMS
SOLUTION;ORAL

HYDROCHLOROTHIAZIDE

MORTON GROVE
ROXANE

A087608
A087213
A087609
A089200
A089201
A085457
A085446
A085440

001
001
001
001
001
001
001
001

Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar

08,
08,
08,
09,
09,
04,
04,
04,

1982

1982

1982

1987

1987

1982

1982

1982

A088358 001 Apr 10, 1984

A088356 001 Apr 10, 1984

A088357 001 Apr 10, 1984

N012026 002

A085827 001

A085373 001

A084897 001

A084291 001

A087085 001

A085771 001

A084876 001

A083770 001

A083877 001

A088570
A088376
A085549
A087556

001 Apr 10, 1984

001 Oct 28, 1983

001

001

A087709 001 May 13, 1982

A087210 001

N012193 005

A085893 001

A086298 001

A084617 001

N009296 004

N009296 002

12.5MG

A077885 001 Nov 26, 2007

50MG/5ML

50MG/5ML

A089661 001 Jun 20, 1988

A088587 001 Jul 02, 1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-172(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE

SOLUTION;ORAL

HYDROCHLOROTHIAZIDE INTENSOL

ROXANE
100MG/ML

TABLET;ORAL

ESIDRIX

NOVARTIS
25MG

50MG

100MG

HYDRO-D

HALSEY
25MG

50MG

HYDROCHLOROTHIAZIDE

ABC HOLDING
50MG

ACTAVIS ELIZABETH
25MG

50MG

ALRA
25MG

50MG

ASCOT
25MG

50MG

BARR
50MG

DAVA PHARMS INC
100MG

ELKINS SINN
50MG

HEATHER
50MG

HIKMA PHARMS LLC
25MG

IMPAX LABS
25MG

50MG

100MG

INWOOD LABS
25MG

25MG

50MG

IVAX SUB TEVA PHARMS
50MG

100MG

MAST MM
25MG

50MG

MUTUAL PHARM
25MG

50MG

100MG

MYLAN
25MG

50MG

PVT FORM
50MG

ROXANE
25MG

50MG

50MG

SANDOZ
25MG

25MG

50MG

50MG

SOLVAY
25MG

SUPERPHARM
25MG

50MG

100MG

TEVA
25MG

50MG

TG UNITED LABS
25MG

50MG

USL PHARMA
25MG

50MG

VANGARD
25MG

50MG

WARNER CHILCOTT
25MG

50MG

WATSON LABS
25MG

25MG

25MG

50MG

50MG

50MG

50MG

50MG

100MG

100MG

A088588 001 Jul 02, 1984

N011793 005

N011793 008

N011793 009

A086504 001

A083891 002

A085672
A085054
A085208
A086369
A083554
A087539
A087540
A084771
A087060
A085152
A084135
A084878
A084029
A083607
A085098
A084776
A085067
A084776
A084658
A085022
A086192
A086192
A083972
A083972
A083972
A084880
A085112
A086597
A085004
A084536
A085005
A083899
A087565
A084912
A085219
A085323
A088827
A088828
A088829
A088924
A088923
A085683
A083965
A087827
A087752
A087638
A087610
A087586
A087587
A081189
A083458
A085232
A083232
A083456
A085233
A086087
A086594
A081190
A085099

001

002

001

001

001

001
001
001

001

002

001

002
001

002

001

001

001

002

001

001

001

002

001

002

003

001

001

001

001

002

001

001

001
001

001

001

001
001
001
001
001
001

001

001
001
001

001

001
001
001
001

002

001

001

001

001

001

001
001

Feb 03, 1982

Feb 03, 1982

Jul 12, 2006

Mar 09, 1982

Dec
Dec
Dec
Feb
Feb

28,
28,
28,
07,
07,

1984

1984

1984

1985

1985

Apr 19, 1982

Apr 19, 1982

May 03, 1982

May 03, 1982

Jan 24, 1992

Jan 24, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-173(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE

TABLET;ORAL

HYDROCHLOROTHIAZIDE

WEST WARD

WHITEWORTH TOWN PLSN

HYDRODIURIL

MERCK

ORETIC

ABBVIE

ZIDE

SOLVAY

100MG

25MG

25MG

50MG

100MG

A087002
A084899
A083809
A083809
A085347

25MG

50MG

100MG

N011835 003

N011835 006

N011835 007

25MG

N011971 001

50MG

A083925 001

HYDROCHLOROTHIAZIDE; IRBESARTAN

TABLET;ORAL

AVALIDE

SANOFI AVENTIS US

12.5MG;75MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

25MG;300MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

IRBESARTAN AND HYDROCHLOROTHIAZIDE

TEVA
25MG;300MG

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

TABLET;ORAL

NORMOZIDE

SCHERING

25MG;100MG

25MG;200MG

25MG;300MG

25MG;400MG

TRANDATE HCT

GLAXOSMITHKLINE

25MG;100MG

25MG;200MG

25MG;300MG

25MG;400MG

HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

LISINOPRIL AND HYDROCHLOROTHIAZIDE

SANDOZ

12.5MG;10MG

12.5MG;20MG

25MG;20MG

TEVA

12.5MG;10MG

12.5MG;20MG

25MG;20MG

PRINZIDE

MERCK

12.5MG;10MG

12.5MG;20MG

25MG;20MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET;ORAL

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

WATSON LABS
12.5MG;50MG

12.5MG;100MG

25MG;100MG

HYDROCHLOROTHIAZIDE; METHYLDOPA

TABLET;ORAL

ALDORIL 15

MERCK
15MG;250MG

ALDORIL 25

MERCK
25MG;250MG

ALDORIL D30

MERCK
30MG;500MG

001

001

002

001

001

N020758 001
Sep 30, 1997

N020758 004
Mar 15, 2005

A077369 003
Mar 30, 2012

N019046
N019046
N019046
N019046

001

002

003

004

Apr
Apr
Apr
Apr

06,
06,
06,
06,

1987

1987

1987

1987

N019174
N019174
N019174
N019174

001

002

003

004

Apr
Apr
Apr
Apr

10,
10,
10,
10,

1987

1987

1987

1987

A075926
A075926
A075926
A075869
A075869
A075869

001

002

003

001

002

003

Jul
Jul
Jul
Jul
Jul
Jul

01,
01,
01,
01,
01,
01,

2002

2002

2002

2002

2002

2002

N019778 003
Nov 18, 1993

N019778 001
Feb 16, 1989

N019778 002
Feb 16, 1989

A200180 001
Jan 12, 2011

A200180 002
Jan 12, 2011

A200180 003
Jan 12, 2011

N013402 001

N013402 002

N013402 003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-174(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; METHYLDOPA

TABLET;ORAL

ALDORIL D50

MERCK
50MG;500MG
METHYLDOPA AND HYDROCHLOROTHIAZIDE

DAVA PHARMS INC
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
IVAX SUB TEVA PHARMS
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
PAR PHARM
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
PARKE DAVIS
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
PUREPAC PHARM
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
SANDOZ
15MG;250MG
15MG;250MG
25MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
TEVA
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
WATSON LABS
15MG;250MG
15MG;250MG
15MG;250MG
25MG;250MG
25MG;250MG
25MG;250MG
30MG;500MG
30MG;500MG
30MG;500MG
50MG;500MG
50MG;500MG
50MG;500MG

N013402 004

A072507
A072508
A072509
A072510
A071458
A071459
A071460
A071461
A070616
A070612
A070613
A070614
A071897
A071898
A071899
A071900
A070853
A070688
A070854
A070689
A070182
A070829
A070183
A070830
A070543
A070544
A071819
A071820
A071821
A071822
A070365
A070958
A071920
A070366
A070959
A071921
A070367
A071069
A071922
A070368
A070960
A071923

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Nov
Nov
Nov
Nov
Oct
Apr
Oct
Apr
Jan
Mar
Jan
Mar
Jan
Jan
Apr
Apr
Apr
Apr
Mar
Feb
Aug
Apr
Jan
Aug
Mar
Jan
Aug
Apr
Feb
Aug

02,
02,
02,
02,
08,
08,
08,
08,
02,
02,
02,
02,
23,
23,
23,
23,
08,
24,
08,
24,
15,
09,
15,
09,
15,
15,
08,
08,
08,
08,
19,
06,
29,
16,
19,
29,
19,
19,
29,
16,
06,
29,

1989

1989

1989

1989

1988

1988

1988

1988

1987

1987

1987

1987

1987

1987

1987

1987

1986

1986

1986

1986

1986

1987

1986

1987

1986

1986

1988

1988

1988

1988

1986

1989

1988

1986

1989

1988

1986

1989

1988

1986

1989

1988

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET;ORAL

LOPRESSOR HCT

US PHARMS HOLDINGS I
50MG;100MG

N018303 003 Dec 31, 1984

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

PADDOCK LLC
12.5MG;7.5MG
12.5MG;15MG
25MG;15MG

A090096 001 Sep 25, 2008

A090096 002 Sep 25, 2008

A090096 003 Sep 25, 2008

HYDROCHLOROTHIAZIDE; PINDOLOL

TABLET;ORAL

VISKAZIDE

NOVARTIS

25MG;5MG
25MG;10MG

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

INDERIDE LA 120/50

WYETH AYERST
50MG;120MG
INDERIDE LA 160/50

WYETH AYERST
50MG;160MG
INDERIDE LA 80/50

WYETH AYERST
50MG;80MG

N018872 001 Jul 22, 1987

N018872 002 Jul 22, 1987

N019059 002 Jul 03, 1985

N019059 003 Jul 03, 1985

N019059 001 Jul 03, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-175(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL

INDERIDE-40/25

WYETH PHARMS INC

25MG;40MG

INDERIDE-80/25

WYETH PHARMS INC

25MG;80MG

PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE

DURAMED PHARMS BARR
25MG;40MG

25MG;80MG

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

ACTAVIS ELIZABETH

25MG;40MG

25MG;80MG

ANI PHARMS INC

25MG;40MG

25MG;80MG

IVAX SUB TEVA PHARMS
25MG;40MG

25MG;80MG

SANDOZ

25MG;40MG

25MG;80MG

WARNER CHILCOTT

25MG;40MG

25MG;80MG

WATSON LABS

25MG;40MG

25MG;40MG

25MG;80MG

25MG;80MG

HYDROCHLOROTHIAZIDE; RESERPINE

TABLET;ORAL

H.R.-50

WHITEWORTH TOWN PLSN
50MG;0.125MG

HYDRO-RESERP

ABC HOLDING

50MG;0.125MG

HYDRO-SERP "25"

SANDOZ

25MG;0.125MG

HYDRO-SERP "50"

SANDOZ

50MG;0.125MG

HYDROCHLOROTHIAZIDE W/ RESERPINE

IVAX SUB TEVA PHARMS 25MG;0.1MG

25MG;0.125MG

50MG;0.1MG

50MG;0.125MG

PHARMERAL
25MG;0.125MG

50MG;0.125MG

ROXANE
50MG;0.125MG

WATSON LABS
25MG;0.125MG

25MG;0.125MG

25MG;0.125MG

50MG;0.125MG

50MG;0.125MG

50MG;0.125MG

HYDROPRES 25

MERCK
25MG;0.125MG

HYDROPRES 50

MERCK
50MG;0.125MG

RESERPINE AND HYDROCHLOROTHIAZIDE

BARR
25MG;0.125MG

50MG;0.125MG

SANDOZ
50MG;0.125MG

RESERPINE AND HYDROCHLOROTHIAZIDE-50

WEST WARD
50MG;0.125MG

SERPASIL-ESIDRIX #1

NOVARTIS
25MG;0.1MG

SERPASIL-ESIDRIX #2

NOVARTIS
50MG;0.1MG

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

TABLET;ORAL

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

ASCOT

25MG;25MG

MUTUAL PHARM

25MG;25MG

PUREPAC PHARM

25MG;25MG

SANDOZ

25MG;25MG

SUPERPHARM

25MG;25MG

WATSON LABS

25MG;25MG

N018031 001

N018031 002

A071126 001 Mar 02, 1987

A071127 001 Mar 02, 1987

A070851
A070852
A070704
A070705
A071552
A071553
A071060
A071061
A071771
A071772
A070301
A071498
A070305
A071501

001
001
001
001
001
001
001
001
001
001
001
001
001
001

May
May
Oct
Oct
Dec
Dec
Aug
Aug
Jan
Jan
Apr
Dec
Apr
Dec

15,
15,
01,
01,
01,
01,
26,
26,
26,
26,
18,
18,
18,
18,

1986

1986

1986

1986

1988

1988

1987

1987

1988

1988

1986

1991

1986

1991

A085338 001

A084714 002 Jun 29, 1982

A084827 001

A085213 001

A083572
A083571
A083568
A083573
A085421
A085420
A084603
A084466
A085317
A086330
A083666
A084467
A086331

001

001

001

001

001

001

001

001

001

002

001

001

001

N011958 002

N011958 003

A084580 001

A084579 001

A088200 001 Jan 31, 1984

A088189 001 May 10, 1984

N011878 003

N011878 005

A088025
A087267
A087999
A086881
A089137
A087398

001 Nov 23, 1984

001

001 Nov 06, 1985

001

001 Aug 26, 1985

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-176(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

TABLET;ORAL

SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE

IVAX PHARMS
25MG;25MG

LEDERLE
25MG;25MG

PARKE DAVIS
25MG;25MG

PUREPAC PHARM
25MG;25MG

UPSHER SMITH
25MG;25MG

USL PHARMA
25MG;25MG

VANGARD
25MG;25MG

WATSON LABS
25MG;25MG

25MG;25MG

A087004
A087511
A087948
A088054
A087553
A087651
A087655
A085974
A086026

HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE

TABLET;ORAL

TIMOLIDE 10-25

MERCK
25MG;10MG

N018061 001

HYDROCHLOROTHIAZIDE; TRIAMTERENE

CAPSULE;ORAL

DYAZIDE

GLAXOSMITHKLINE LLC
25MG;50MG

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

ANI PHARMS INC
25MG;37.5MG

NOVARTIS
25MG;37.5MG

VITARINE
25MG;50MG

TABLET;ORAL

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

AM THERAP
50MG;75MG

QUANTUM PHARMICS
50MG;75MG

WATSON LABS
50MG;75MG

002 May 24, 1982

001

001 Feb 22, 1983

001 Aug 18, 1983

001

001

001

001

001

N016042 002

A074970 001 Jan 06, 1998

A074857 001 Sep 09, 1997

A071737 001 Feb 12, 1988

A072022 001 Apr 17, 1988

A071980 001 Apr 17, 1988

A071969 001 Apr 17, 1988

HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

SYRUP;ORAL

CODAMINE

ALPHARMA US PHARMS

5MG/5ML;25MG/5ML

A075103 001 Sep 29, 2000

HYDROCORTAMATE HYDROCHLORIDE

OINTMENT;TOPICAL

MAGNACORT

PFIZER

0.5%

N010554 001

0.5%

A085805 001

0.5%

1%

N009585 003

N009585 001

1%

A083011 002

1%

2.5%

A080459 001

A084055 001

0.5%

1%

2.5%

A087136 003 Apr 08, 1982

A087136 002 Apr 08, 1982

A087136 001 Apr 08, 1982

0.5%

A086823 001

0.5%

A080438 001

1%

A080438 002

0.5%

1%

A080482 003

A080482 004

2.5%

A080483 001

2.5%

0.5%

1%

1%

A089754
A080848
A080848
A086080

HYDROCORTISONE

AEROSOL;TOPICAL

AEROSEB-HC

ALLERGAN HERBERT

CREAM;TOPICAL

CORT-DOME

BAYER PHARMS

DERMACORT

MONARCH PHARMS

ELDECORT

VALEANT PHARM INTL

FLEXICORT

WESTWOOD SQUIBB

H-CORT

PHARM ASSOC

HC #1

BAYER PHARMS

HC #4

BAYER PHARMS

HC (HYDROCORTISONE)

C AND M PHARMA

HI-COR

C AND M PHARMA

HYDROCORTISONE

ALPHARMA US PHARMS

ALTANA

AMBIX

001 Feb 01, 1989

002

003

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-177(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE

CREAM;TOPICAL

HYDROCORTISONE

EVERYLIFE
G AND W LABS
INGRAM PHARM
IVAX PHARMS
NASKA
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
STIEFEL
SYOSSET
TARO
TEVA

TOPIDERM
USL PHARMA
WHITEWORTH TOWN PLSN
HYTONE

VALEANT INTL
NOGENIC HC

IVAX PHARMS
NUTRACORT

DOW PHARM
PENECORT

ALLERGAN HERBERT
PROCTOCORT

MONARCH PHARMS
SYNACORT

MEDICIS
GEL;TOPICAL

NUTRACORT

HEALTHPOINT
PENECORT

ALLERGAN HERBERT
INJECTABLE;INJECTION

CORTEF

PHARMACIA AND UPJOHN
LOTION;TOPICAL

ACTICORT

BAKER NORTON
ALA-CORT

CROWN LABS
BALNEOL-HC

SOLVAY
BETA-HC

BETA DERMAC
CETACORT

DOW PHARM
CORT-DOME

BAYER PHARMS
DERMACORT

SOLVAY
EPICORT

BLULINE
GLYCORT

HERAN

2.5%

0.5%

1%

1%

0.5%

1%

1%

1%

0.5%

1%

1%

2.5%

1%

1%

0.5%

0.5%

1%

0.5%

1%

1%

2.5%

1%

1%

2.5%

1%

A086271
A080452
A080452
A084059
A080456
A080456
A085733
A089706
A084970
A085026
A088845
A089413
A087838
A086170
A085527
A086154
A086155
A080400
A080400
A085191
A080400
A089273
A088027
A088029
A080496

001

001

002

001

002

003

001

001
002

001

001
001
001
001

001

001

001

002

003

001

004

001
001
001
002

1%

2.5%

A080472 003

A080472 004

1%

A087427 001 Apr 04, 1988

0.5%

1%

A080442 002

A080442 003

1%

A088216 001 Jun 06, 1984

1%

A083011 001

0.5%

A087459 001

1%

A084698 001

1%

A088215 001 Jun 06, 1984

50MG/ML

N009864 001

1%

A086535 001

1%

A083201 001

1%

A088041 001 Dec 03, 1982

1%

A089495 001 Jan 25, 1988

0.5%

1%

A080426 002

A080426 001

0.5%

1%

N009895 003

N009895 001

0.5%

1%

A084573 002

A086462 001

0.5%

A083219 002

1%

A087489 001 Oct 03, 1983

Mar 10, 1988

Feb 27, 1986

Dec 16, 1986

Jul 28, 1982

Feb 17, 1989

Sep 27, 1983

Sep 27, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-178(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE

LOTION;TOPICAL

H-CORT

PHARM ASSOC
HYDROCORTISONE

ALPHARMA US PHARMS
MERICON
NASKA
PERRIGO NEW YORK
TARO
HYTONE

VALEANT INTL
NUTRACORT

DOW PHARM
STIE-CORT

PERRIGO CO
OINTMENT;TOPICAL

CORTRIL

PFIZER GLOBAL
HC (HYDROCORTISONE)

C AND M PHARMA
HYDROCORTISONE

ALTANA
AMBIX
NASKA
PERRIGO NEW YORK
PHARMADERM
TARO
USL PHARMA
HYTONE

DERMIK LABS
PENECORT

ALLERGAN HERBERT
POWDER;FOR RX COMPOUNDING

H-CORT

TORCH
HYDRO-RX

X GEN PHARMS
HYDROCORTISONE

PADDOCK LLC
SOLUTION;TOPICAL

PENECORT

ALLERGAN HERBERT
TEXACORT

MISSION PHARMA
TABLET;ORAL

CORTRIL

PFIZER
HYDROCORTISONE

BARR
ELKINS SINN
FERRANTE
IMPAX LABS
INWOOD LABS
LANNETT
NEXGEN PHARMA INC
PANRAY

0.5%

A086824 001

0.5%

1%

0.5%

1%

1%

0.5%

1%

1%

A087317
A087315
A085282
A085282
A089705
A085662
A085663
A089024

1%

2.5%

A080473 003

A080473 004 Nov 30, 1982

0.5%

1%

A080443 002

A080443 003

1%

A089066 001 Nov 25, 1985

1%

2.5%

N009176 001

N009176 002

0.5%

1%

A080481 001

A080481 002

0.5%

1%

1%

2.5%

1%

0.5%

1%

1%

0.5%

2.5%

1%

2.5%

A080489
A080489
A086079
A086272
A089704
A084969
A085028
A088842
A086256
A040310
A088061
A088039

1%

2.5%

A080474 003

A080474 004

2.5%

A088217 001 Jun 06, 1984

100%

A087834 001 Mar 29, 1982

100%

A085982 001

100%

A088082 001 Apr 08, 1983

1%

A088214 001 Jun 06, 1984

1%

A080425 001

10MG

20MG

N009127 005

N009127 003

20MG

20MG

10MG

20MG

20MG

20MG

20MG

20MG

10MG

A083999
A080624
A080568
A080568
A080781
A080732
A085070
A083140
N009659

001
001
001

002
001
001

001

001

002

003

001

001

001
003

001

001
001

001
001
001

001

001

001

002

001

001

001

001

001

Jun 07, 1982

Jun 07, 1982

Feb 26, 1987

Apr 25, 1988

Feb 12, 1986

Mar 10, 1988

Feb 09, 1987

Dec 29, 2000

Sep 27, 1983

Sep 27, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-179(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE

TABLET;ORAL

HYDROCORTISONE

PARKE DAVIS
PUREPAC PHARM

ROXANE
SANDOZ
WATSON LABS
WHITEWORTH TOWN PLSN
HYDROCORTONE

MERCK
TABLET;VAGINAL

CORTRIL

PFIPHARMECS
HYDROCORTISONE ACETATE

CREAM;TOPICAL

HEMSOL-HC

ABLE
HYDROCORTISONE ACETATE

CENCI
PARKE DAVIS
PUREPAC PHARM
INJECTABLE;INJECTION

CORTEF ACETATE

PHARMACIA AND UPJOHN
CORTRIL

PFIZER
HYDROCORTISONE ACETATE

AKORN
BEL MAR
WATSON LABS

HYDROCORTONE

MERCK
LOTION;TOPICAL

DRICORT

INGRAM PHARM
OINTMENT;OPHTHALMIC

HYDROCORTISONE ACETATE

FERA PHARMS
OINTMENT;OPHTHALMIC, OTIC

HYDROCORTONE

MERCK
OINTMENT;TOPICAL

CORTEF ACETATE

PHARMACIA AND UPJOHN

PASTE;TOPICAL

ORABASE HCA

COLGATE
POWDER;FOR RX COMPOUNDING

HYDROCORTISONE ACETATE

X GEN PHARMS

20MG
20MG
10MG
20MG
20MG
10MG
20MG
20MG
10MG
20MG

N009659
A084243
A084247
A080395
A084247
A088539
A080642
A080355
A080344
A080344

002

001

003 Aug 31, 1982

001

002

001 Mar 21, 1984

002

001

001

002

10MG
20MG

N008506 007

N008506 011

10MG

N009796 001

1%

A081274 001 Jun 19, 1992

1%
1%
0.5%
1%

A080419
A089914
A086050
A086052

50MG/ML

N009378 002

25MG/ML

N009164 001

25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML

N009637
N009637
A083739
A083739
A083128
A083759
A083759
A085214

25MG/ML
50MG/ML

N008228 001

N008228 004

0.5%

A086207 001

0.5%

A080828 001

1.5%

N009018 003

1%
2.5% **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N008917 002

N008917 001

0.5%

A083205 001

100%

A085981 001

001 Jan 25, 1982

001 Jan 03, 1989

001

001

001

002

001

002

001

001

002

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-180(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE

CREAM;TOPICAL

NEO-CORTEF

PHARMACIA AND UPJOHN
1%;EQ 3.5MG BASE/GM

2.5%;EQ 3.5MG BASE/GM

OINTMENT;OPHTHALMIC

NEO-CORTEF

PHARMACIA AND UPJOHN
0.5%;EQ 3.5MG BASE/GM

1.5%;EQ 3.5MG BASE/GM

OINTMENT;TOPICAL

NEO-CORTEF

PHARMACIA AND UPJOHN
0.5%;EQ 3.5MG BASE/GM

1%;EQ 3.5MG BASE/GM

2.5%;EQ 3.5MG BASE/GM

SUSPENSION/DROPS;OPHTHALMIC

COR-OTICIN

AKORN

1.5%;EQ 3.5MG BASE/ML

NEO-CORTEF

PHARMACIA AND UPJOHN
0.5%;EQ 3.5MG BASE/ML

1.5%;EQ 3.5MG BASE/ML

HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE

SUSPENSION;OPHTHALMIC

TERRA-CORTRIL

PFIZER
1.5%;EQ 5MG BASE/ML

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

AEROSOL, METERED;TOPICAL

HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%

VINTAGE PHARMS

1%;1%

LOTION;TOPICAL

PRAMOSONE

FERNDALE LABS

0.5%;1%

HYDROCORTISONE ACETATE; UREA

CREAM;TOPICAL

CARMOL HC

FOUGERA PHARMS

HYDROCORTISONE BUTYRATE

CREAM;TOPICAL

LOCOID

YAMANOUCHI

OINTMENT;TOPICAL

LOCOID

YAMANOUCHI

SOLUTION;TOPICAL

LOCOID

YAMANOUCHI

HYDROCORTISONE CYPIONATE

SUSPENSION;ORAL

CORTEF

PHARMACIA AND UPJOHN

A061049 001

A061049 002

A060610 001

A060610 002

A060751 001

A060751 002

A060751 003

A060188 001

A060612 002

A060612 001

A061016 001

A089440 001 May 17, 1988

A083213 002

1%;10%

A080505 001

0.1%

N018795 001 Jan 07, 1983

0.1%

N019106 001 Jul 03, 1984

0.1%

N019819 001 Sep 15, 1988

EQ 10MG BASE/5ML

N009900 001

HYDROCORTISONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

HYDROCORTONE

MERCK

EQ 50MG BASE/ML

HYDROCORTISONE SODIUM SUCCINATE

INJECTABLE;INJECTION

A-HYDROCORT

ABBOTT

EQ 100MG BASE/VIAL

EQ 100MG BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

HOSPIRA

EQ 100MG BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

HYDROCORTISONE SODIUM SUCCINATE

ABRAXIS PHARM
EQ 100MG BASE/VIAL

EQ 100MG BASE/VIAL

EQ 250MG BASE/VIAL

N012052 001

A085928
A089577
A089578
A089579
A089580
A085929
A085930
A085931
A085932

001

001
001
001
001
001

001

001

001

Apr
Apr
Apr
Apr

11,
11,
11,
11,

1989

1989

1989

1989

A088667 001 Jun 08, 1984

A088712 001 Jun 08, 1984

A088668 001 Jun 08, 1984

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6-181(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROCORTISONE SODIUM SUCCINATE

INJECTABLE;INJECTION

HYDROCORTISONE SODIUM SUCCINATE

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

BAXTER HLTHCARE

EQ 100MG BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

INTL MEDICATION

EQ 100MG BASE/VIAL

WATSON LABS

EQ 100MG BASE/VIAL

EQ 100MG BASE/VIAL

EQ 250MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

HYDROCORTISONE VALERATE

CREAM;TOPICAL

HYDROCORTISONE VALERATE

G AND W LABS INC

WESTCORT

RANBAXY

OINTMENT;TOPICAL

HYDROCORTISONE VALERATE

FOUGERA PHARMS

WESTCORT

RANBAXY

001 Jun 08, 1984

001 Jun 08, 1984

001

001

001

001

001 Mar 19, 1982

002

001

001

001

001

0.2%

A074489 001 Aug 12, 1998

0.2%

N017950 001

0.2%

A075085 001 Jul 31, 2001

0.2%

N018726 001 Aug 08, 1983

HYDROCORTISONE; NEOMYCIN SULFATE

CREAM;TOPICAL

NEO-CORT-DOME

BAYER PHARMS
0.5%;EQ 3.5MG BASE/GM

1%;EQ 3.5MG BASE/GM

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OTIC

NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE

PHARMAFAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
OTOCORT
WATSON LABS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
SUSPENSION/DROPS;OPHTHALMIC
CORTISPORIN
MONARCH PHARMS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE

PHARMAFAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

SUSPENSION/DROPS;OTIC

NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE

PHARMAFAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

OTICAIR

PHARMAFAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

OTOBIONE

SCHERING
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

OTOCORT

ACTAVIS LABS FL INC
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

HYDROCORTISONE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OTIC

OTOBIOTIC

SCHERING
5MG/ML;EQ 10,000 UNITS BASE/ML

PYOCIDIN

FOREST LABS
5MG/ML;EQ 10,000 UNITS BASE/ML

HYDROCORTISONE; TETRACYCLINE HYDROCHLORIDE

OINTMENT;OPHTHALMIC

ACHROMYCIN

LEDERLE

1.5%;1%

HYDROCORTISONE; UREA

CREAM;TOPICAL

ALPHADERM

BIOGLAN

CALMURID HC

PHARMACIA AND UPJOHN

A088669
A088670
A086619
A087567
A087568
A087569
A087532
A084737
A084738
A084737
A084747
A084748

N050237 006 Jun 05, 1984

N050237 005 Jun 05, 1984

A062394 001 Sep 29, 1982

A060730 002

N050169 001

A062623 001 Sep 24, 1985

A062617 001 Sep 18, 1985

A062399 001 Nov 18, 1982

A061816 001

A062521 001 Jul 11, 1985

A062302 001

A061606 001

N050272 001

1%;10%

A086008 001

1%;10%

A083947 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-182(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROFLUMETHIAZIDE

TABLET;ORAL

DIUCARDIN

WYETH AYERST
HYDROFLUMETHIAZIDE

PAR PHARM
WATSON LABS

50MG

A083383 001

50MG
50MG
50MG

A088850 001 May 31, 1985

A088031 001 Apr 06, 1983

A088528 001 Aug 15, 1984

HYDROFLUMETHIAZIDE; RESERPINE

TABLET;ORAL

HYDROFLUMETHIAZIDE AND RESERPINE

USL PHARMA
50MG;0.125MG
WATSON LABS
25MG;0.125MG
50MG;0.125MG
RESERPINE AND HYDROFLUMETHIAZIDE

IVAX PHARMS
50MG;0.125MG
PAR PHARM
50MG;0.125MG
SALUTENSIN

SHIRE
50MG;0.125MG
SALUTENSIN-DEMI

SHIRE
25MG;0.125MG
HYDROMORPHONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PALLADONE

PURDUE PHARMA LP
12MG
16MG
24MG
32MG
INJECTABLE;INJECTION

DILAUDID-HP

PURDUE PHARM PRODS
250MG/VIAL
HYDROMORPHONE HYDROCHLORIDE

WATSON LABS
10MG/ML
TABLET;ORAL

HYDROMORPHONE HYDROCHLORIDE

NESHER PHARMS
2MG
4MG
8MG
HYDROXOCOBALAMIN

INJECTABLE;INJECTION

ALPHAREDISOL

MERCK
CYANOKIT

SERB SAS
HYDROXOCOBALAMIN

ABRAXIS PHARM
WATSON LABS
HYDROXOMIN

BEL MAR

A088195 001 Oct 26, 1983

A088127 001 Mar 22, 1983

A088110 001 Mar 22, 1983

A088932 001 Jan 11, 1985

A088907 001 Sep 20, 1985

N012359 003

N012359 004

N021044
N021044
N021044
N021044

001
002
003
004

Sep
Sep
Sep
Sep

24,
24,
24,
24,

2004

2004

2004

2004

N019034 002 Aug 04, 1994

A074317 001 Aug 23, 1995

A077311 001 Nov 09, 2005

A077311 002 Nov 09, 2005

A077311 003 Nov 09, 2005

1MG/ML

A080778 001

2.5GM/VIAL (5GM/KIT)

N022041 002 Dec 15, 2006

1MG/ML
1MG/ML

A084921 001

A085528 001

1MG/ML

A084629 001

HYDROXYAMPHETAMINE HYDROBROMIDE

SOLUTION/DROPS;OPHTHALMIC

PAREDRINE

PHARMICS
1%

N000004 004

HYDROXYCHLOROQUINE SULFATE

TABLET;ORAL

HYDROXYCHLOROQUINE SULFATE

SANDOZ
200MG
WATSON LABS
200MG

A040150 001 Jan 27, 1996

A040133 001 Nov 30, 1995

HYDROXYPROGESTERONE CAPROATE

INJECTABLE;INJECTION

DELALUTIN

BRISTOL MYERS SQUIBB

N010347 004

125MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

125MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

250MG/ML **Federal Register

N016911 001

N010347 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-183(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROXYPROGESTERONE CAPROATE

INJECTABLE;INJECTION

DELALUTIN

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

250MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

HYDROXYPROGESTERONE CAPROATE

ACTAVIS LABS UT INC
125MG/ML
250MG/ML
AKORN
125MG/ML
HYDROXYSTILBAMIDINE ISETHIONATE

INJECTABLE;INJECTION

HYDROXYSTILBAMIDINE ISETHIONATE

SANOFI AVENTIS US
225MG/AMP
HYDROXYUREA

CAPSULE;ORAL

HYDROXYUREA

BARR
BARR LABS INC
ROXANE
TABLET;ORAL

HYDROXYUREA

BARR
HYDROXYZINE HYDROCHLORIDE

INJECTABLE;INJECTION

HYDROXYZINE

BAXTER HLTHCARE
HYDROXYZINE HYDROCHLORIDE

ALTANA
BAXTER HLTHCARE
FRESENIUS KABI USA
HOSPIRA

PHARMAFAIR

SMITH AND NEPHEW

SOLOPAK

WATSON LABS

WYETH AYERST
ORGATRAX

ORGANON USA INC
VISTARIL

PFIZER
SYRUP;ORAL

ATARAX

ROERIG
HYDROXYZINE HYDROCHLORIDE

ALPHARMA US PHARMS
KV PHARM
STI PHARMA LLC

N016911 002

N017439 001

N017439 002

N018004 001

N009166 001

250MG
250MG
500MG
500MG

A075143
A075020
A075020
A074476

002
002
001
001

1GM

A075734 001 Aug 29, 2000

50MG/ML

A085551 002

25MG/ML
50MG/ML
25MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
50MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML
25MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML
25MG/ML
50MG/ML

A087273
A087273
A085551
A088184
A088185
A087416
A086821
A087546
A088862
A089106
A088881
A089107
A087592
A086822
A087591
A087310
A087593
A087595
A087596
A085778
A087274
A085779
A087274
A086258
A086258

25MG/ML
50MG/ML

A087014 001

A087014 002

25MG/ML
50MG/ML

N011111 001

N011111 002

10MG/5ML

N010485 001

10MG/5ML
10MG/5ML
10MG/5ML

A088785 001 Feb 03, 1988

A087730 001 Jul 01, 1982

A086880 001

001
002
001

001
001
001

001

001

001
001
001
001
001

001

001

001

001

001

001

001

001

001

002

001

002

Sep
Jun
Jul
Aug

21,
26,
30,
18,

2000

2000

1998

1995

Apr 20, 1982

Apr 20, 1982

Mar 31, 1983

Mar 31, 1983

Feb
Feb
Feb
Feb

14,
14,
14,
14,

1986

1986

1986

1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-184(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROXYZINE HYDROCHLORIDE

TABLET;ORAL

ATARAX

PFIZER

HYDROXYZINE HYDROCHLORIDE

ABLE

ACTAVIS ELIZABETH

HALSEY

IVAX PHARMS

KV PHARM

MUTUAL PHARM

PLIVA

PUREPAC PHARM

QUANTUM PHARMICS

SANDOZ

SUPERPHARM

USL PHARMA

VINTAGE

WATSON LABS

HYDROXYZINE PAMOATE

CAPSULE;ORAL

HY-PAM "25"

TEVA

HYDROXYZINE PAMOATE

DURAMED PHARMS BARR

IVAX SUB TEVA PHARMS

10MG

25MG

50MG

100MG

N010392
N010392
N010392
N010392

001

004

006

005

10MG

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

100MG

10MG

10MG

25MG

25MG

50MG

50MG

100MG

100MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

10MG

25MG

25MG

50MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

10MG

10MG

25MG

25MG

25MG

50MG

50MG

50MG

A040559
A040562
A040563
A089071
A089072
A089073
A089366
A089117
A089396
A087216
A087410
A087411
A087819
A087820
A087821
A087822
A088409
A089381
A087857
A089382
A087860
A089383
A087862
A081054
A088120
A088121
A088122
A088540
A088551
A088529
A087246
A087869
A085247
A087870
A087245
A087871
A088794
A088795
A088796
A089121
A089122
A089123
A087602
A087603
A087604
A081149
A086827
A088348
A081150
A086829
A088349
A081151
A086836
A088350

001
001
001
001
001
001
001
001
001
001

001

001

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002

001
001

001
001

001
001
001
001
001
001
001
001
001
001
001
001

001
001
001

001
001
001

001

EQ 25MG HCL

A088713 001 Mar 04, 1985

EQ
EQ
EQ
EQ
EQ

A088593
A088594
A088595
A087761
A087760

25MG HCL

50MG HCL

100MG HCL

25MG HCL

50MG HCL

001
001
001
001
001

Jul
Jul
Jul
Jul
Jul
Jul
May
May
May

22,
22,
22,
22,
22,
22,
02,
02,
02,

2004

2004

2004

1986

1986

1986

1988

1988

1988

Jun
Jun
Jun
Jun
Nov
May
Apr
May
Apr
May
Apr
Sep
Sep
Sep
Sep
Oct
Oct
Oct

23,
23,
23,
23,
15,
19,
18,
19,
18,
19,
18,
25,
25,
25,
25,
22,
22,
22,

1982

1982

1982

1982

1983

1986

1983

1986

1983

1986

1983

1995

1984

1984

1984

1985

1985

1985

Dec 20, 1982

Dec 20, 1982

Dec
Dec
Dec
Dec
Mar
Mar
Mar
Jan
Jan
Jan
Mar

20,
05,
05,
05,
20,
20,
20,
22,
22,
22,
18,

1982

1984

1984

1984

1986

1986

1986

1982

1982

1982

1994

Sep 15, 1983

Mar 18, 1994

Sep 15, 1983

Mar 18, 1994

Sep 15, 1983

Feb
Feb
Feb
Mar
Mar

29,
29,
29,
05,
05,

1984

1984

1984

1982

1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-185(of 347)

DISCONTINUED DRUG PRODUCT LIST

HYDROXYZINE PAMOATE

CAPSULE;ORAL

HYDROXYZINE PAMOATE

PAR PHARM

SANDOZ

SUPERPHARM

VANGARD

WATSON LABS

VISTARIL

PFIZER

SUSPENSION;ORAL

VISTARIL

PFIZER

IBANDRONATE SODIUM

TABLET;ORAL

BONIVA

HOFFMANN LA ROCHE

IBUPROFEN

CAPSULE;ORAL

MIDOL

BAYER

SOLUTION;INTRAVENOUS

CALDOLOR

CUMBERLAND PHARMS

SUSPENSION;ORAL

CHILDREN'S ADVIL

WYETH CONS

IBU

ABBOTT

MOTRIN

MCNEIL CONSUMER

SUSPENSION/DROPS;ORAL

MOTRIN

MCNEIL

TABLET;ORAL

ACHES-N-PAIN

LEDERLE

CAP-PROFEN

PERRIGO

IBU

BASF

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

25MG HCL

25MG HCL

50MG HCL

50MG HCL

100MG HCL

25MG HCL

50MG HCL

100MG HCL

25MG HCL

50MG HCL

100MG HCL

25MG HCL

50MG HCL

25MG HYDROCHLORIDE

25MG HCL

25MG HCL

50MG HCL

50MG HCL

50MG HCL

100MG HCL

100MG HCL

100MG HCL

A087656
A089145
A087657
A089146
A087658
A081127
A081128
A081129
A089031
A089032
A089033
A088392
A088393
A081165
A086698
A086840
A086695
A086705
A087767
A086697
A086728
A087790

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

Jun
Mar
Jun
Mar
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Sep
Sep
Jul

11,
17,
11,
17,
11,
28,
28,
28,
02,
02,
02,
19,
19,
31,

1982

1986

1982

1986

1982

1991

1991

1991

1987

1987

1987

1983

1983

1991

Jul 01, 1982

Jul 01, 1982

Aug 16, 1982

Oct 05, 1982

Aug 16, 1982

EQ 100MG HCL

N011459 006

EQ 25MG HCL/5ML

N011795 001

EQ 2.5MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N021455 001
May 16, 2003

200MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

200MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

A070626 001
Sep 02, 1987

400MG/4ML (100MG/ML)

N022348 001
Jun 11, 2009

100MG/5ML

N019833 002
Sep 19, 1989

100MG/5ML

N019784 001
Dec 18, 1989

100MG/5ML

N019842 001
Sep 19, 1989

40MG/ML

N020476 001
May 25, 1995

200MG

A071065 001
May 28, 1987

200MG

A072097 001
Dec 08, 1987

400MG

400MG

600MG

600MG

800MG

A070083
N018197
A070088
A070099
A070745

A071002 001
Sep 02, 1987

001

001

001

001

001

Feb 22, 1985

Feb 08, 1985

Mar 29, 1985

Jul 23, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-186(of 347)

DISCONTINUED DRUG PRODUCT LIST

IBUPROFEN

TABLET;ORAL

IBU-TAB

ALRA

IBUPRIN

PLIVA

IBUPROFEN

ABBOTT

ANI PHARMS INC

CONTRACT PHARMACAL

HALSEY

IVAX SUB TEVA PHARMS

LEDERLE

LEINER

MCNEIL

MUTUAL PHARM

MYLAN

NORTHSTAR HLTHCARE

OHM LABS

PAR PHARM

PERRIGO

PLIVA

PUREPAC PHARM

SANDOZ

SUPERPHARM

TEVA

800MG

A071965 001 Aug 11, 1988

200MG

A071773 001 Jul 16, 1987

600MG
800MG
200MG
200MG
200MG
200MG
200MG
300MG
400MG
600MG
800MG
200MG
200MG
400MG
600MG
800MG
400MG
600MG
300MG
400MG
600MG
200MG
200MG
200MG
400MG
600MG
800MG
200MG
400MG
600MG
800MG
400MG
600MG
800MG
400MG
200MG
300MG
400MG
600MG
800MG
200MG
400MG
600MG
800MG
200MG
200MG
300MG
400MG
600MG
800MG
200MG
200MG
200MG
200MG
300MG
400MG
400MG
600MG
600MG
800MG
800MG
600MG
200MG
400MG
600MG

A070556
A071264
A071144
A072901
A072903
A073691
A071027
A071028
A071029
A071030
A072137
A071154
A072040
A071145
A071146
A071769
A070629
A070630
A071266
A070081
A070476
A070493
A070908
A071462
A070079
A070080
A071448
A071870
A070045
A070057
A071999
A078132
A078132
A078132
A070818
A071575
A070328
A070329
A070330
A070986
A072098
A071666
A071667
A071668
A071122
A071664
A071123
A071124
A071125
A071964
A070733
A071807
A074525
A074533
A070734
A070735
A072064
A070736
A072065
A071938
A072169
A070709
A073141
A073343
A073344

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
003
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jul
Jan
Dec
Dec
Feb
Sep
Mar
Mar
Mar
Feb
Oct
Apr
Sep
Sep
May
Sep
Sep
Oct
Jun
Jun
Dec
Sep
Oct
Jul
Jul
Feb
May
Sep
Sep
Dec
Sep
Sep
Sep
Dec
May
Aug
Aug
Aug
Jul
Dec
Jun
Jun
Jun
Oct
Feb
Sep
Sep
Sep
Feb
Sep
Feb
Dec
Dec
Jun
Jun
Jan
Jun
Jan
Jan
Dec
Apr
May
Jun
Jun

14,
25,
20,
19,
19,
25,
29,
23,
23,
23,
05,
27,
29,
23,
23,
08,
19,
19,
15,
16,
16,
24,
26,
02,
24,
24,
18,
05,
24,
24,
03,
10,
10,
10,
26,
08,
06,
06,
06,
25,
08,
18,
18,
18,
03,
03,
19,
19,
19,
01,
19,
25,
15,
15,
12,
12,
14,
12,
14,
14,
11,
25,
29,
30,
30,

1985
1986
1987
1991
1991
1994
1987
1987
1987
1987
1988
1987
1988
1986
1986
1987
1986
1986
1986
1986
1986
1985
1986
1986
1985
1985
1987
1988
1985
1985
1987
2007
2007
2007
1985
1987
1985
1985
1985
1986
1987
1987
1987
1987
1986
1987
1986
1986
1986
1988
1986
1988
1995
1995
1986
1986
1988
1986
1988
1988
1987
1986
1992
1992
1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-187(of 347)

DISCONTINUED DRUG PRODUCT LIST

IBUPROFEN

TABLET;ORAL

IBUPROFEN

VINTAGE PHARMS

WATSON LABS

IBUPROHM

OHM LABS
MEDIPREN

MCNEIL
MIDOL

BAYER
MOTRIN

MCNEIL CONSUMER

MCNEIL PED
MOTRIN MIGRAINE PAIN

J AND J CONSUMER INC
NUPRIN

BRISTOL MYERS
J AND J CONSUMER INC
RUFEN

BASF
TABLET, CHEWABLE;ORAL

MOTRIN

MCNEIL PED

800MG
200MG
300MG
400MG
600MG
800MG
200MG
200MG
200MG
300MG
400MG
400MG
600MG
600MG
800MG
800MG

A073345
A072249
A071230
A071231
A071232
A072004
A070435
A071765
A071905
A071338
A070038
A070436
A070041
A070437
A071547
A071911

400MG

A070469 001 Aug 29, 1985

200MG
200MG

A070475 001 Feb 06, 1986

A071215 001 Jun 26, 1986

200MG
200MG

A070591 001 Sep 02, 1987

A071001 001 Sep 02, 1987

300MG
400MG
600MG
800MG
100MG

N017463
N017463
N017463
N017463
N020418

200MG

N019012 004 Feb 25, 2000

200MG
200MG
200MG
200MG

A072035
A072036
N019012
N019012

600MG

N018197 002 Mar 05, 1984

50MG
100MG

N020135 001 Nov 16, 1994

N020135 002 Nov 16, 1994

IBUPROFEN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

COMBUNOX

FOREST LABS
400MG;5MG
IDARUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

IDAMYCIN

PHARMACIA AND UPJOHN

IDARUBICIN HYDROCHLORIDE

SANDOZ
TEVA PARENTERAL

IDOXURIDINE

OINTMENT;OPHTHALMIC

STOXIL

GLAXOSMITHKLINE
SOLUTION/DROPS;OPHTHALMIC

STOXIL

GLAXOSMITHKLINE

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jan
Oct
Oct
Oct
Nov
Mar
Sep
Mar
Dec
Sep
Aug
Sep
Aug
Jul
Oct

30,
10,
22,
22,
22,
18,
05,
04,
08,
01,
06,
21,
06,
21,
02,
13,

1992

1989

1986

1986

1986

1987

1986

1987

1988

1986

1985

1985

1985

1985

1987

1987

003

002

004

005 May 22, 1985

001 Nov 16, 1994

001
001
001
002

Feb
Feb
May
Jul

16,
16,
18,
29,

1988

1988

1984

1987

N021378 001 Nov 26, 2004

5MG/VIAL
10MG/VIAL
20MG/VIAL

N050661 002 Sep 27, 1990

N050661 001 Sep 27, 1990

N050661 003 Apr 25, 1995

1MG/ML
5MG/VIAL
10MG/VIAL
20MG/VIAL

A091293
A065037
A065037
A065037

0.5%

N015868 001

0.1%

N013934 001

001
003
002
001

Mar
May
May
May

29,
01,
01,
01,

2011

2002

2002

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-188(of 347)

DISCONTINUED DRUG PRODUCT LIST

IFOSFAMIDE; MESNA

INJECTABLE;INJECTION

IFEX/MESNEX KIT

BAXTER HLTHCARE

ILOPROST

SOLUTION;INHALATION

VENTAVIS

ACTELION PHARMS LTD

IMATINIB MESYLATE

CAPSULE;ORAL

GLEEVEC

NOVARTIS

IMIPRAMINE HYDROCHLORIDE

CONCENTRATE;ORAL

IMIPRAMINE HYDROCHLORIDE

NOVARTIS

INJECTABLE;INJECTION

TOFRANIL

NOVARTIS

TABLET;ORAL

IMIPRAMINE HYDROCHLORIDE

LEDERLE

PAR PHARM

PROSAM LABS

ROXANE

SANDOZ

TEVA

USL PHARMA

VANGARD

WATSON LABS

WEST WARD

JANIMINE

ABBOTT

PRAMINE

ALRA

PRESAMINE

SANOFI AVENTIS US

INAMRINONE LACTATE

INJECTABLE;INJECTION

AMRINONE LACTATE

BAXTER HLTHCARE CORP

HOSPIRA

INOCOR

SANOFI AVENTIS US

1GM/VIAL;100MG/ML

3GM/VIAL;100MG/ML

N019763 003 Oct 10, 1992

N019763 004 Oct 10, 1992

20MCG/2ML (10MCG/ML)

N021779 001 Dec 29, 2004

EQ 50MG BASE

EQ 100MG BASE

N021335 001 May 10, 2001

N021335 002 May 10, 2001

25MG/ML

A086765 001

12.5MG/ML

N011838 002

10MG

25MG

50MG

25MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

10MG

25MG

50MG

25MG

10MG

25MG

50MG

10MG

10MG

25MG

25MG

50MG

50MG

25MG

50MG

A086269
A086267
A086268
A089497
A040753
A040752
A040751
A083799
A083799
A083799
A085200
A084869
A085133
A083729
A083729
A083729
A087776
A088036
A087619
A087631
A085220
A085875
A084252
A085878
A085221
A085877
A088222
A088223

10MG

25MG

50MG

N017895 001

N017895 002

N017895 003

10MG

25MG

50MG

A083827 001

A083827 002

A083827 003

10MG

25MG

50MG

N011836 006

N011836 003

N011836 007

EQ 5MG BASE/ML

EQ 5MG BASE/ML

A075542 001 May 10, 2000

A074616 001 Aug 03, 1998

EQ 5MG BASE/ML

N018700 001 Jul 31, 1984

001

001

001

001
001
001
001
001

002

003

001

002

001

001

004

003

001
001
001
001
001

001

002

001

001

001

001
001

Jul
Feb
Feb
Feb

14,
28,
28,
28,

1987

2008

2008

2008

Feb
Nov
Feb
Jan

10,
03,
09,
04,

1982

1982

1982

1982

May 26, 1983

May 26, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-189(of 347)

DISCONTINUED DRUG PRODUCT LIST

INDAPAMIDE

TABLET;ORAL

INDAPAMIDE

AMERIGEN PHARMS LTD
ANI PHARMS INC
SANDOZ
TEVA
WATSON LABS
LOZOL

SANOFI AVENTIS US

1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG

A075201
A075201
A074498
A074498
A074594
A074594
A074665
A074665
A074585
A074585

1.25MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

2.5MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N018538 002 Apr 29, 1993

INDECAINIDE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

DECABID

LILLY
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
INDINAVIR SULFATE

CAPSULE;ORAL

CRIXIVAN

MERCK SHARP DOHME
INDOCYANINE GREEN

INJECTABLE;INJECTION

IC-GREEN

AKORN

INDOMETHACIN

CAPSULE;ORAL

INDO-LEMMON

TEVA
INDOCIN

IROKO PHARMS LLC
INDOMETHACIN

ABLE
CYCLE PHARMS LTD
DURAMED PHARMS BARR
HALSEY
IVAX SUB TEVA PHARMS
MUTUAL PHARM

MYLAN
PARKE DAVIS
PIONEER PHARMS
PLIVA
SUPERPHARM

001
002
002
001
001
002
001
002
001
002

Dec
Dec
Feb
Oct
May
May
Apr
Apr
Sep
Sep

04,
04,
12,
31,
23,
23,
04,
04,
26,
26,

1998

1998

1998

1996

1996

1996

1997

1997

1996

1996

N018538 001 Jul 06, 1983

N019693 001 Dec 29, 1989

N019693 002 Dec 29, 1989

N019693 003 Dec 29, 1989

EQ 100MG BASE
EQ 333MG BASE

N020685 006 Apr 19, 2000

N020685 005 Dec 17, 1998

10MG/VIAL
40MG/VIAL
50MG/VIAL

N011525 003

N011525 004

N011525 002

25MG
50MG

A070266 001 Nov 07, 1985

A070267 001 Nov 07, 1985

25MG
50MG

N016059 001

N016059 002

25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
50MG
50MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG

A076666
A076666
A070353
A070354
A070326
A070327
A070782
A070635
N018730
N018730
A070067
A070899
A070068
A070900
N018858
N018806
N018806
A070813
A070592
A071148
A071149
A070487
A070488

001
002
001
001
001
001
001
001
001
002
001
001
001
001
002
001
002
001
001
001
001
001
001

Dec
Dec
Jun
Jun
Oct
Oct
Jun
Jun
May
May
Oct
Feb
Oct
Feb
Apr
Nov
Nov
Aug
Aug
Mar
Mar
Oct
Oct

17,
17,
18,
18,
18,
18,
03,
03,
04,
04,
03,
09,
03,
09,
20,
23,
23,
11,
11,
18,
18,
10,
10,

2003

2003

1985

1985

1985

1985

1987

1987

1984

1984

1986

1987

1986

1987

1984

1984

1984

1986

1986

1987

1987

1986

1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-190(of 347)

DISCONTINUED DRUG PRODUCT LIST

INDOMETHACIN

CAPSULE;ORAL

INDOMETHACIN

TEVA

25MG
50MG
VINTAGE
25MG
50MG
50MG
WATSON LABS
25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
50MG
CAPSULE, EXTENDED RELEASE;ORAL

INDOCIN SR

IROKO PHARMS
75MG
INDOMETHACIN

ABLE
75MG
INWOOD LABS
75MG
SUPPOSITORY;RECTAL

INDOCIN

IROKO PHARMS
50MG
SUSPENSION;ORAL

INDOMETHACIN

CYCLE PHARMS LTD
25MG/5ML

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE;SUBCUTANEOUS

NOVOLOG MIX 50/50

NOVO NORDISK INC

50 UNITS/ML;50 UNITS/ML
NOVOLOG MIX 70/30 PENFILL

NOVO NORDISK INC

210 UNITS/3ML;90 UNITS/3ML (70
UNITS/ML; 30 UNITS/ML)

210 UNITS/3ML;90 UNITS/3ML (70

UNITS/ML; 30 UNITS/ML)

INSULIN ASPART RECOMBINANT

INJECTABLE;SUBCUTANEOUS

NOVOLOG INNOLET

NOVO NORDISK INC
INSULIN DETEMIR RECOMBINANT

INJECTABLE;SUBCUTANEOUS

LEVEMIR INNOLET

NOVO NORDISK INC
LEVEMIR PENFILL

NOVO NORDISK INC

INSULIN PORK

INJECTABLE;INJECTION

ILETIN I

LILLY
INSULIN

NOVO NORDISK INC
REGULAR INSULIN

NOVO NORDISK INC

001
001
002
001
001
001
001
001
001
001
001
001
001
002

Apr
Apr
Aug
Mar
Aug
Oct
Aug
Jul
Jul
Oct
Aug
May
Jul
Jul

18,
18,
06,
05,
06,
18,
20,
31,
31,
18,
20,
18,
31,
31,

1988

1988

1984

1986

1984

1985

1986

1991

1984

1985

1986

1987

1991

1984

N018185 001 Feb 23, 1982

A076114 001 Feb 06, 2002

A072410 001 Mar 15, 1989

N017814 001 Aug 13, 1984

A071412 001 Mar 18, 1987

N021810 001 Aug 26, 2008

N021172 002 Nov 01, 2001

N021172 003 Nov 01, 2001

300 UNITS/3ML (100 UNITS/ML)

N020986 004 Apr 23, 2004

300 UNITS/3ML (100 UNITS/ML)

N021536 003 Jun 16, 2005

300 UNITS/3ML (100 UNITS/ML)

N021536 004 Jun 16, 2005

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

INJECTABLE;INJECTION

HUMALOG MIX 50/50 PEN

LILLY
50 UNITS/ML;50 UNITS/ML
HUMALOG MIX 75/25 PEN

LILLY
75 UNITS/ML;25 UNITS/ML
INSULIN LISPRO RECOMBINANT

INJECTABLE;INJECTION

HUMALOG PEN

LILLY

A071342
A071343
N018829
A070651
N018829
A070529
A070784
A072996
N018690
A070530
A070785
A071635
A072997
N018690

N021018 003 Dec 22, 1999

N021017 003 Dec 22, 1999

100 UNITS/ML

N020563 002 Aug 06, 1998

500 UNITS/ML

N017931 001

40 UNITS/ML

N017926 001

100 UNITS/ML

N017926 003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

INSULIN PURIFIED BEEF

INJECTABLE;INJECTION

REGULAR ILETIN II

LILLY

100 UNITS/ML

INSULIN PURIFIED PORK

INJECTABLE;INJECTION

ILETIN II

LILLY

500
REGULAR ILETIN II (PORK)

LILLY
100
REGULAR PURIFIED PORK INSULIN

NOVO NORDISK INC
100
VELOSULIN

NOVO NORDISK INC
100

N018478 001

UNITS/ML

N018344 002

UNITS/ML

N018344 001

UNITS/ML

N018381 001

UNITS/ML

N018193 001

INSULIN PURIFIED PORK; INSULIN SUSP ISOPHANE PURIFIED PORK

INJECTABLE;INJECTION

INSULIN NORDISK MIXTARD (PORK)

NOVO NORDISK INC

30 UNITS/ML;70 UNITS/ML

INSULIN RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN BR

LILLY

VELOSULIN BR

NOVO NORDISK INC

POWDER;INHALATION

EXUBERA

PFIZER

6-191(of 347)

N018195 001

100 UNITS/ML

N019529 001 Apr 28, 1986

100 UNITS/ML

N021028 001 Jul 19, 1999

1MG/INH

3MG/INH

N021868 001 Jan 27, 2006

N021868 002 Jan 27, 2006

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN 50/50

LILLY
50 UNITS/ML;50 UNITS/ML

INSULIN RECOMBINANT PURIFIED HUMAN

INJECTABLE;INJECTION

NOVOLIN R
NOVO NORDISK INC
100 UNITS/ML
VELOSULIN BR HUMAN
NOVO NORDISK INC
100 UNITS/ML

N020100 001 Apr 29, 1992

N018778 001 Aug 30, 1983

N019450 001 May 30, 1986

INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE;INJECTION

MIXTARD HUMAN 70/30

BAYER PHARMS

30 UNITS/ML;70 UNITS/ML

N019585 001 Mar 11, 1988

NOVOLIN 70/30

NOVO NORDISK INC

30 UNITS/ML;70 UNITS/ML

N019441 001 Jul 11, 1986

INSULIN SUSP ISOPHANE BEEF

INJECTABLE;INJECTION

NPH INSULIN

NOVO NORDISK INC

40 UNITS/ML

100 UNITS/ML

N017929 001

N017929 003

INSULIN SUSP ISOPHANE BEEF/PORK

INJECTABLE;INJECTION

NPH ILETIN I (BEEF-PORK)

LILLY

40 UNITS/ML

100 UNITS/ML

N017936 001

N017936 002

INSULIN SUSP ISOPHANE PURIFIED BEEF

INJECTABLE;INJECTION

NPH ILETIN II

LILLY
100 UNITS/ML

N018479 001

INSULIN SUSP ISOPHANE PURIFIED PORK

INJECTABLE;INJECTION

INSULIN INSULATARD NPH NORDISK

NOVO NORDISK INC
100 UNITS/ML

NPH ILETIN II (PORK)

LILLY
100 UNITS/ML

NPH PURIFIED PORK ISOPHANE INSULIN

NOVO NORDISK INC
100 UNITS/ML

N018194 001

N018345 001

N018623 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE;INJECTION

INSULATARD NPH HUMAN
NOVO NORDISK INC
100 UNITS/ML
NOVOLIN N
NOVO NORDISK INC
100 UNITS/ML
INSULIN SUSP PROTAMINE ZINC BEEF/PORK

INJECTABLE;INJECTION

PROTAMINE ZINC & ILETIN I (BEEF-PORK)

LILLY
40 UNITS/ML

100 UNITS/ML

INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF

INJECTABLE;INJECTION

PROTAMINE ZINC AND ILETIN II

LILLY
100 UNITS/ML

PROTAMINE ZINC INSULIN

BRISTOL MYERS SQUIBB
40 UNITS/ML

100 UNITS/ML

INSULIN SUSP PROTAMINE ZINC PURIFIED PORK

INJECTABLE;INJECTION

PROTAMINE ZINC AND ILETIN II (PORK)

LILLY
100 UNITS/ML

INSULIN ZINC SUSP BEEF

INJECTABLE;INJECTION

LENTE INSULIN

NOVO NORDISK INC

6-192(of 347)

N019449 001 May 30, 1986

N019065 001 Jan 23, 1985

N017932 001

N017932 002

N018476 001

N017928 001

N017928 003

N018346 001

40 UNITS/ML

100 UNITS/ML

N017998 001

N017998 003

INSULIN ZINC SUSP EXTENDED BEEF

INJECTABLE;INJECTION

ULTRALENTE INSULIN

NOVO NORDISK INC
100 UNITS/ML

N017997 003

INSULIN ZINC SUSP EXTENDED PURIFIED BEEF

INJECTABLE;INJECTION

ULTRALENTE

NOVO NORDISK INC
100 UNITS/ML

N018385 001

INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN U

LILLY
40 UNITS/ML

100 UNITS/ML

N019571 001 Jun 10, 1987

N019571 002 Jun 10, 1987

INSULIN ZINC SUSP PROMPT BEEF

INJECTABLE;INJECTION

SEMILENTE INSULIN

NOVO NORDISK INC

100 UNITS/ML

N017996 003

INSULIN ZINC SUSP PROMPT PURIFIED PORK

INJECTABLE;INJECTION

SEMILENTE

NOVO NORDISK INC
100 UNITS/ML

N018382 001

INSULIN ZINC SUSP PURIFIED BEEF

INJECTABLE;INJECTION

LENTE ILETIN II

LILLY
100 UNITS/ML

N018477 001

INSULIN ZINC SUSP PURIFIED BEEF/PORK

INJECTABLE;INJECTION

LENTARD

NOVO NORDISK INC
100 UNITS/ML

N018384 001

INSULIN ZINC SUSP PURIFIED PORK

INJECTABLE;INJECTION

LENTE

NOVO NORDISK INC
100 UNITS/ML

LENTE ILETIN II (PORK)

LILLY
100 UNITS/ML

N018383 001

N018347 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

INSULIN ZINC SUSP RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN L
LILLY
100 UNITS/ML
NOVOLIN L
NOVO NORDISK INC
100 UNITS/ML

6-193(of 347)

N019377 002 Sep 30, 1985

N019965 001 Jun 25, 1991

INSULIN ZINC SUSP SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE;INJECTION

NOVOLIN L

NOVO NORDISK INC
100 UNITS/ML

N018777 001 Aug 30, 1983

INULIN

INJECTABLE;INJECTION

INULIN AND SODIUM CHLORIDE

ISO TEX
100MG/ML

N002282 001

INVERT SUGAR

INJECTABLE;INJECTION

TRAVERT 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
10GM/100ML

N016717 001

IOBENGUANE SULFATE I-131

INJECTABLE;INJECTION

IOBENGUANE SULFATE I 131

PHARMALUCENCE

2.3mCi/ML

N020084 001 Mar 25, 1994

IOCETAMIC ACID

TABLET;ORAL

CHOLEBRINE

MALLINCKRODT

750MG

N017129 001

65%

N017902 001

IODAMIDE MEGLUMINE

INJECTABLE;INJECTION

RENOVUE-65

BRACCO
RENOVUE-DIP

BRACCO

24%

N017903 001

IODIPAMIDE MEGLUMINE

INJECTABLE;INJECTION

CHOLOGRAFIN MEGLUMINE

BRACCO

10.3%

N009321 007

IODIPAMIDE SODIUM

INJECTABLE;INJECTION

CHOLOGRAFIN SODIUM

BRACCO

20%

N009321 001

IODOHIPPURATE SODIUM I-123

INJECTABLE;INJECTION

NEPHROFLOW

GE HEALTHCARE

1mCi/ML

N018289 001 Dec 28, 1984

IODOHIPPURATE SODIUM I-131

INJECTABLE;INJECTION

HIPPURAN I 131

MALLINCKRODT
0.25mCi/ML

HIPPUTOPE

BRACCO
1-2mCi/VIAL

IODOHIPPURATE SODIUM I 131

PHARMALUCENCE
0.2mCi/ML

IODOXAMATE MEGLUMINE

INJECTABLE;INJECTION

CHOLOVUE

BRACCO

9.9%

40.3%

IOFETAMINE HYDROCHLORIDE I-123

INJECTABLE;INJECTION

SPECTAMINE

IMP
1mCi/ML

N016666 001

N015419 002

N017313 001

N018077 001

N018076 001

N019432 001 Dec 24, 1987

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6-194(of 347)

DISCONTINUED DRUG PRODUCT LIST

IOHEXOL

INJECTABLE;INJECTION

OMNIPAQUE 210

GE HEALTHCARE
SOLUTION;URETHRAL

OMNIPAQUE 70

GE HEALTHCARE
IOPAMIDOL

INJECTABLE;INJECTION

IOPAMIDOL

BAXTER HLTHCARE

HOSPIRA

45.3%

N018956 006 Jun 30, 1989

15.1%

N018956 007 Jun 01, 1994

41%
51%
61%
76%
61%
76%

A074629
A074629
A074629
A074629
A074734
A074734

IOPAMIDOL-200

COOK IMAGING
41%
HOSPIRA
41%
IOPAMIDOL-200 IN PLASTIC CONTAINER

HOSPIRA
41%
IOPAMIDOL-250

COOK IMAGING
51%
FRESENIUS KABI USA
51%
HOSPIRA
51%
51%
IOPAMIDOL-250 IN PLASTIC CONTAINER

HOSPIRA
51%
IOPAMIDOL-300

ABBVIE
61%
COOK IMAGING
61%
FRESENIUS KABI USA
61%
HOSPIRA
61%
61%
IOPAMIDOL-300 IN PLASTIC CONTAINER

HOSPIRA
61%
61%
IOPAMIDOL-370

COOK IMAGING
76%
FRESENIUS KABI USA
76%
HOSPIRA
76%
76%
IOPAMIDOL-370 IN PLASTIC CONTAINER

HOSPIRA
76%
ISOVUE-128

BRACCO
26%
ISOVUE-200

BRACCO
41%

001
004
002
003
001
002

1996

1998

1996

1996

1996

1996

A074636 001 Dec 30, 1997

A074881
A074679
A074898
A075005

002
001
002
001

Jul
Apr
Dec
Feb

28,
02,
30,
24,

2000

1997

1997

1998

A074636 002 Dec 30, 1997

A074638
A074881
A074679
A074898
A075005

001
003
002
003
002

Apr
Jul
Apr
Dec
Feb

30,
28,
02,
30,
24,

1997

2000

1997

1997

1998

A074636 003 Dec 30, 1997

A074637 001 Apr 03, 1997

A074881
A074679
A074898
A075005

004
003
004
003

Jul
Apr
Dec
Feb

28,
02,
30,
24,

2000

1997

1997

1998

A074636 004 Dec 30, 1997

N018735 005 Oct 21, 1986

N020327 001 Oct 12, 1994

500MG

N008032 001

IOPHENDYLATE

INJECTABLE;INJECTION

PANTOPAQUE

ALCON

100%

N005319 001

IOTHALAMATE SODIUM

INJECTABLE;INJECTION

ANGIO-CONRAY

MALLINCKRODT
CONRAY 325

MALLINCKRODT
CONRAY 400

MALLINCKRODT

06,
31,
06,
06,
10,
10,

A074881 001 Jul 28, 2000

A074898 001 Dec 30, 1997

IOPANOIC ACID

TABLET;ORAL

TELEPAQUE

GE HEALTHCARE

IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM

INJECTABLE;INJECTION

VASCORAY

MALLINCKRODT
52%;26%

Nov
Mar
Nov
Nov
Dec
Dec

N016783 001

80%

N013319 001

54.3%

N017685 001

66.8%

N014295 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-195(of 347)

DISCONTINUED DRUG PRODUCT LIST

IOTROLAN

INJECTABLE;INTRATHECAL

OSMOVIST 190

BAYER HLTHCARE
OSMOVIST 240

BAYER HLTHCARE
IOVERSOL

INJECTABLE;INJECTION

OPTIRAY 160

LIEBEL-FLARSHEIM
OPTIRAY 240

LIEBEL-FLARSHEIM

40.6%

N019580 001 Dec 07, 1989

51.3%

N019580 002 Dec 07, 1989

34%

N019710 003 Dec 30, 1988

51%

N020923 001 May 28, 1998

IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

INJECTABLE;INJECTION

HEXABRIX

GUERBET

39.3%;19.6%

N018905 002 Jul 26, 1985

IPODATE CALCIUM

GRANULE;ORAL

ORAGRAFIN CALCIUM

BRACCO

3GM/PACKET

N012968 001

500MG

A087768 001 Aug 11, 1982

500MG

N012967 001

0.018MG/INH

N019085 001 Dec 29, 1986

0.02%

N020228 001 Sep 29, 1993

0.02%

0.02%

0.02%

0.02%

0.02%

A075111
A075441
A075507
A075867
A075313

0.021MG/SPRAY

0.042MG/SPRAY

A076156 001 Apr 18, 2003

A076155 001 Apr 18, 2003

40MG/2ML (20MG/ML)

100MG/5ML (20MG/ML)

A077994 001 Feb 27, 2008

A077994 002 Feb 27, 2008

EQ 50MG IRON/ML

N010787 002

EQ 65MG BASE/3.25ML (EQ 20MG BASE/ML)

EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)

N021135 005 Mar 29, 2013

N021135 003 Mar 29, 2005

1%

A086711 001

0.25%

1%

N012339 009

N012339 008

1%

0.062%

0.062%

A087101 001

A087937 001 Nov 15, 1982

A089614 001 Jun 13, 1991

IPODATE SODIUM

CAPSULE;ORAL

BILIVIST

BAYER HLTHCARE

ORAGRAFIN SODIUM

BRACCO

IPRATROPIUM BROMIDE

AEROSOL, METERED;INHALATION

ATROVENT

BOEHRINGER INGELHEIM

SOLUTION;INHALATION

ATROVENT

BOEHRINGER INGELHEIM

IPRATROPIUM BROMIDE

ACTAVIS MID ATLANTIC

APOTEX INC

PHARMASCIENCE INC

ROXANE

TEVA PHARMS USA

SPRAY, METERED;NASAL

IPRATROPIUM BROMIDE

APOTEX INC

IRINOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

IRINOTECAN HYDROCHLORIDE

SANDOZ

IRON DEXTRAN

INJECTABLE;INJECTION

IRON DEXTRAN

SANOFI AVENTIS US

IRON SUCROSE

INJECTABLE;INTRAVENOUS

VENOFER

LUITPOLD

ISOETHARINE HYDROCHLORIDE

SOLUTION;INHALATION

BETA-2

NEPHRON

BRONKOSOL

SANOFI AVENTIS US

ISOETHARINE HYDROCHLORIDE

ALPHARMA US PHARMS

ASTRAZENECA

001
001
001
001
001

Apr
Mar
Jan
Jul
Feb

22,
28,
19,
22,
07,

1999

2001

2001

2002

2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-196(of 347)

DISCONTINUED DRUG PRODUCT LIST

ISOETHARINE HYDROCHLORIDE

SOLUTION;INHALATION

ISOETHARINE HYDROCHLORIDE

0.125%
0.125%
0.167%
0.167%
0.2%
0.2%
0.25%
0.25%
BAXTER HLTHCARE
0.08%
0.14%
0.25%
DEY
0.08%
0.1%
0.17%
0.25%
1%
INTL MEDICATION
0.077%
0.08%
0.1%
0.143%
0.167%
0.2%
0.25%
1%
PARKE DAVIS
0.5%
1%
ROXANE
0.1%
0.125%
0.167%
0.2%
0.25%
1%
ISOETHARINE HYDROCHLORIDE S/F

DEY
0.08%
0.1%
0.17%
0.25%
1%
ISOETHARINE MESYLATE

AEROSOL, METERED;INHALATION

BRONKOMETER

SANOFI AVENTIS US
ISOETHARINE MESYLATE

ALPHARMA US PHARMS

A087938
A089615
A088470
A089616
A088471
A089617
A088472
A089618
A088144
A088145
A088146
A088187
A087389
A087390
A088188
A086763
A086651
A086651
A086651
A086651
A086651
A086651
A086651
A086651
A085997
A085889
A087396
A087025
A088226
A087324
A088275
A086899

001
001
001
001
001
001
001
001
001
001
001
001
001

001

001
001

001

002

003

004

005

006

007

008

001

001

001

001

001
001

001
001

Nov
Jun
Mar
Jun
Mar
Jun
Mar
Jun
Jul
Mar
Aug
Dec

A089817
A089818
A089819
A089820
A089252

001
001
001
001
001

Nov
Nov
Nov
Nov
Sep

0.34MG/INH

N012339 007

15,
13,
14,
13,
14,
13,
14,
13,
29,
26,
01,
03,

1982

1991

1984

1991

1984

1991

1984

1991

1983

1984

1983

1982

Dec 03, 1982

Sep 16, 1983

Jun 03, 1983

22,
22,
22,
22,
15,

1988

1988

1988

1988

1986

0.34MG/INH

A087858 001 Aug 21, 1984

ISOFLURANE

LIQUID;INHALATION

ISOFLURANE

WATSON LABS INC

99.9%

A074393 001 May 12, 1995

ISOFLUROPHATE

OINTMENT;OPHTHALMIC

FLOROPRYL

MERCK

0.025%

N010656 001

100MG/ML

N008662 001

25MG/ML
100MG/ML

N008420 002

N008420 003

50MG/5ML

A081118 001 Jul 21, 1997

50MG/5ML

A089243 001 Feb 03, 1986

50MG/5ML

N008420 001

ISONIAZID

INJECTABLE;INJECTION

NYDRAZID

SANDOZ
RIMIFON

ROCHE
SYRUP;ORAL

ISONIAZID

MIKART
LANIAZID

LANNETT
RIMIFON

ROCHE

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6-197(of 347)

DISCONTINUED DRUG PRODUCT LIST

ISONIAZID

TABLET;ORAL

DOW-ISONIAZID

DOW PHARM
HYZYD

MEDPOINTE PHARM HLC

300MG

A080330 002

100MG
300MG

A080134 003

A080134 004

300MG

A080935 001

100MG

300MG

50MG

100MG

300MG

100MG

100MG

300MG

100MG

300MG

100MG

300MG

100MG

100MG

300MG

100MG

50MG

100MG

300MG

100MG

100MG

50MG

100MG

50MG

100MG

50MG

100MG

100MG

100MG

300MG

300MG

300MG

100MG

A088231
A088119
A083632
A080212
A087425
A080153
A080270
A083610
N008499
N008499
A040090
A040090
A080941
A080136
A083633
A084050
N008428
N008428
N008428
A083060
A085091
A080368
A080368
A080132
A080132
A080522
A080401
A080523
A085790
A080521
A083178
A085784
A080120

50MG

100MG

A080140 001

A080140 002

100MG

N008392 003

100MG

300MG

A080126 001

A080126 002

ISONIAZID; RIFAMPIN

CAPSULE;ORAL

RIFAMPIN AND ISONIAZID

HIKMA INTL PHARMS

150MG;300MG

A065221 001 Jul 29, 2005

ISOPROPAMIDE IODIDE

TABLET;ORAL

DARBID

GLAXOSMITHKLINE

EQ 5MG BASE

N010744 001

INH
NOVARTIS
ISONIAZID

DURAMED PHARMS BARR
HALSEY
HIKMA INTL PHARMS
IMPAX LABS
IVAX SUB TEVA PHARMS
LILLY
MIKART
MK LABS
MUTUAL PHARM
NEXGEN PHARMA INC
PANRAY

PERRIGO
PHARMAVITE
PHOENIX LABS NY
PUREPAC PHARM
WATSON LABS

WHITEWORTH TOWN PLSN

LANIAZID

LANNETT
NYDRAZID

BRISTOL MYERS SQUIBB
STANOZIDE

EVERYLIFE

ISOPROTERENOL HYDROCHLORIDE

AEROSOL, METERED;INHALATION

ISOPROTERENOL HYDROCHLORIDE

3M
0.12MG/INH

ALPHARMA US PHARMS
0.12MG/INH

ISUPREL

SANOFI AVENTIS US
0.103MG/INH

DISC;INHALATION

NORISODRINE AEROTROL

ABBOTT
0.25%

001
001
001

001

001

001

001

001

002

003

001
002
001

001

001

001

001

002

003

001

001

001

002

003
004
001

001

001

001

001

001

001

002

N010375 004

A085904 001

N011178 001

N016814 001

Mar 17, 1983

Mar 17, 1983

Jun 26, 1997

Jun 26, 1997

Jul 14, 1982

Jul 14, 1982

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6-198(of 347)

DISCONTINUED DRUG PRODUCT LIST

ISOPROTERENOL HYDROCHLORIDE

INJECTABLE;INJECTION

ISOPROTERENOL HYDROCHLORIDE

ABRAXIS PHARM
0.2MG/ML
BAXTER HLTHCARE
0.2MG/ML
HOSPIRA
0.02MG/ML
0.2MG/ML
INTL MEDICATION
0.2MG/ML
SOLUTION;INHALATION

AEROLONE

LILLY
0.25%
ISOPROTERENOL HYDROCHLORIDE

ARMOUR PHARM
0.031%
0.062%
DEY
0.5%
PARKE DAVIS
0.25%
0.5%
ISUPREL

SANOFI AVENTIS US
0.5%
1%
VAPO-ISO

FISONS
0.5%
TABLET;RECTAL, SUBLINGUAL

ISUPREL

SANOFI AVENTIS US
10MG
15MG

N006328 001

N006328 002

ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE

AEROSOL, METERED;INHALATION

DUO-MEDIHALER

3M
0.16MG/INH;0.24MG/INH

N013296 001

ISOPROTERENOL SULFATE

AEROSOL, METERED;INHALATION

MEDIHALER-ISO

3M
POWDER;INHALATION

NORISODRINE

ABBVIE
ISOSORBIDE

SOLUTION;ORAL

ISMOTIC

ALCON

A083431
A083486
A083283
A083346
A083724

001

001

001

001

001

N007245 001

A087935
A087936
A086764
A085994
A085540

001 Nov 18, 1982

001 Nov 18, 1982

001 Jan 04, 1982

001

001

N006327 002

N006327 003

N016813 001

0.08MG/INH

N010375 003

10%
25%

N006905 003

N006905 002

100GM/220ML

N017063 001

ISOSORBIDE DINITRATE

CAPSULE, EXTENDED RELEASE;ORAL

ISORDIL

WYETH AYERST
40MG
TABLET;ORAL

ISORDIL

VALEANT PHARMS NORTH
10MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

20MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

30MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

ISOSORBIDE DINITRATE

MUTUAL PHARM
5MG
10MG
20MG
30MG
SUPERPHARM
5MG
10MG
20MG
WATSON LABS
5MG
10MG

N012882 002 Jul 29, 1988

N012093 002 Jul 29, 1988

N012093 006 Jul 29, 1988

N012093 005 Jul 29, 1988

A086166
A086169
A086167
A087564
A089190
A089191
A089192
A086034
A086032

002
001
001
001
001
001
001
001
001

Sep
Sep
Sep
Sep
Feb
Feb
Feb
Jan
Jan

19,
19,
19,
18,
17,
17,
17,
06,
07,

1986

1986

1986

1986

1987

1987

1987

1988

1988

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6-199(of 347)

DISCONTINUED DRUG PRODUCT LIST

ISOSORBIDE DINITRATE

TABLET;ORAL

SORBITRATE

ASTRAZENECA

TABLET;SUBLINGUAL

ISORDIL

BIOVAIL

ISOSORBIDE DINITRATE

HIKMA INTL PHARMS
MUTUAL PHARM

SANDOZ
WATSON LABS

SORBITRATE

ASTRAZENECA

5MG
10MG
20MG
30MG
40MG

N016192
N016192
A086405
A088124
A088125

2.5MG
5MG
10MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N012940 004 Jul 29, 1988

N012940 003 Jul 29, 1988

N012940 005 Jul 29, 1988

2.5MG
5MG
2.5MG
5MG
10MG
2.5MG
5MG
2.5MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

5MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

A086054
A086055
A084204
A086168
A087545
A086225
A086222
A086033

2.5MG
5MG

N016191 002 Apr 01, 1996

N016191 001 Apr 01, 1996

TABLET, CHEWABLE;ORAL

SORBITRATE

ASTRAZENECA

5MG
10MG
TABLET, EXTENDED RELEASE;ORAL

ISORDIL

WYETH AYERST
40MG
ISOSORBIDE MONONITRATE

TABLET;ORAL

ISMO

PROMIUS PHARMA
20MG
TABLET, EXTENDED RELEASE;ORAL

IMDUR

SCHERING PLOUGH
30MG
60MG
120MG
ISOSORBIDE MONONITRATE

ACTAVIS ELIZABETH
30MG
60MG
ALKERMES GAINESVILLE
60MG
IVAX SUB TEVA PHARMS
30MG
60MG
120MG
SKYEPHARMA AG
60MG
ISOSULFAN BLUE

INJECTABLE;INJECTION

LYMPHAZURIN

COVIDIEN

1% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

001
002
002
001
001

001
001
001
001
001
001
001
001

Apr
Apr
Aug
Aug
Aug

Oct
Nov
Sep
Sep
Sep
Feb
Feb
Feb

01,
01,
21,
21,
21,

29,
02,
18,
18,
18,
19,
19,
26,

1996

1996

1990

1990

1990

1987

1987

1986

1986

1986

1988

1988

1988

A086031 001 Sep 29, 1987

N016776 002 Apr 01, 1996

N016776 003 Apr 01, 1996

N012882 001 Jul 29, 1988

N019091 001 Dec 30, 1991

N020225 001 Aug 12, 1993

N020225 002 Aug 12, 1993

N020225 003 Mar 30, 1995

A075306
A075306
A075041
A075448
A075448
A075448
A075166

001
002
001
002
001
003
001

N018310 001

Dec
Dec
Sep
Aug
Jun
Aug
Oct

31,
31,
22,
07,
19,
07,
07,

1998

1998

1998

2001

2000

2001

1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-200(of 347)

DISCONTINUED DRUG PRODUCT LIST

ISOTRETINOIN

CAPSULE;ORAL

ACCUTANE

HOFFMANN LA ROCHE

10MG
20MG
40MG

ISRADIPINE

CAPSULE;ORAL

DYNACIRC

SMITHKLINE BEECHAM

2.5MG
5MG
TABLET, EXTENDED RELEASE;ORAL

DYNACIRC CR

GLAXOSMITHKLINE LLC
5MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

10MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N018662 002 May 07, 1982

N018662 004 Mar 28, 1983

N018662 003 May 07, 1982

N019546 001 Dec 20, 1990

N019546 002 Dec 20, 1990

N020336 001 Jun 01, 1994

N020336 002 Jun 01, 1994

ITRACONAZOLE

INJECTABLE;INJECTION

SPORANOX

JANSSEN PHARMS

10MG/ML

N020966 001 Mar 30, 1999

IVERMECTIN

TABLET;ORAL

STROMECTOL

MERCK SHARP DOHME

6MG

N050742 001 Nov 22, 1996

EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE

A060516 001

A061911 001

A062726 001 Mar 06, 1987

EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
EQ 1GM BASE/3ML

A062324 001

A062324 002

A062324 003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

75MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
500MG BASE/2ML
1GM BASE/3ML
75MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
75MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
75MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
1GM BASE/3ML
1GM BASE/3ML

A062504
A062504
A062504
A062466
A062466
A063021
A063022
A063025
A062668
A062672
A062669
A062605
A062605
A062605
A063092
A062520

001
002
003
001
002
001
001
001
001
001
001
003
001
002
001
003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

75MG BASE/2ML
75MG BASE/2ML
75MG BASE/2ML
500MG BASE/2ML
500MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
1GM BASE/3ML
1GM BASE/3ML

A061655
A061901
A062564
A061655
A061901
A062564
A061655
A061901
A062564

003

003

001 Sep 21, 1984

001

001

002 Sep 21, 1984

002

002

003 Sep 21, 1984

KANAMYCIN SULFATE

CAPSULE;ORAL

KANTREX

APOTHECON

INJECTABLE;INJECTION

KANAMYCIN

EUROHLTH INTL SARL

KANAMYCIN SULFATE

ABRAXIS PHARM

INTL MEDICATION
LOCH

PHARMAFAIR

SOLOPAK

WARNER CHILCOTT
WATSON LABS
KANTREX

APOTHECON

KLEBCIL

KING PHARMS

EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
EQ 1GM BASE/3ML

A062170 001

A062170 002

A062170 003

Apr
Apr
Apr
Sep
Sep
Jul
Jul
Jul
May
May
May
Feb
Feb
Feb
Oct
May

05,
05,
05,
30,
30,
31,
31,
31,
07,
07,
07,
26,
26,
26,
11,
09,

1984

1984

1984

1983

1983

1992

1992

1992

1987

1987

1987

1986

1986

1986

1989

1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-201(of 347)

DISCONTINUED DRUG PRODUCT LIST

KETOCONAZOLE

CREAM;TOPICAL

NIZORAL

JANSSEN PHARMA
SUSPENSION;ORAL

NIZORAL

JANSSEN PHARMA
TABLET;ORAL

KETOCONAZOLE

AAIPHARMA LLC
APOTEX
MUTUAL PHARMA
PLIVA
TEVA
NIZORAL

JANSSEN PHARMS
KETOPROFEN

CAPSULE;ORAL

KETOPROFEN

SANDOZ
TEVA
ORUDIS

WYETH AYERST

2%

N019084 001 Dec 31, 1985

100MG/5ML

A070767 001 Nov 07, 1986

200MG
200MG
200MG
200MG
200MG

A075341
A075912
A075314
A075362
A074971

200MG

N018533 001

50MG
75MG
25MG

A074024 001 Dec 29, 1995

A074024 002 Dec 29, 1995

A073515 001 Dec 22, 1992

25MG
50MG
75MG
CAPSULE, EXTENDED RELEASE;ORAL

KETOPROFEN

ALKERMES GAINESVILLE
200MG
ORUVAIL

WYETH PHARMS INC
100MG
150MG
200MG
FILM;ORAL

NEXCEDE

NOVARTIS
12.5MG
TABLET;ORAL

ACTRON

BAYER
12.5MG
KETOPROFEN

PERRIGO
12.5MG
ORUDIS KT

WYETH CONS
12.5MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

KETOROLAC TROMETHAMINE

INJECTABLE;INJECTION

KETOROLAC TROMETHAMINE

APOTEX INC
APOTHECON
BEDFORD

CLARIS PHARMASERVICE
EUROHLTH INTL SARL
GLAND PHARMA LTD

30MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

15MG/ML
30MG/ML **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

30MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML

001
001
001
001
001

Jul
Jan
Jun
Jun
Jun

27,
10,
15,
15,
15,

1999

2002

1999

1999

1999

N018754 001 Jul 31, 1987

N018754 002 Jan 09, 1986

N018754 003 Jan 09, 1986

A074879 001 Dec 10, 1997

N019816 003 Feb 08, 1995

N019816 002 Feb 08, 1995

N019816 001 Sep 24, 1993

N022470 001 Nov 25, 2009

N020499 001 Oct 06, 1995

A075364 001 Feb 07, 2002

N020429 001 Oct 06, 1995

A075626
A077201
A075348
A075348
A075222

001
001
001
002
001

Jul
Oct
Nov
Nov
Apr

24,
14,
28,
28,
26,

2001

2005

2000

2000

1999

A075230 002 Oct 25, 1999

A075222 002 Apr 26, 1999

A075228 001 Apr 26, 1999

A075230
A075631
A075631
A075772
A075772
A076722
A076722

001
002
001
001
002
001
002

Oct
Jun
Jun
Jul
Jul
Jul
Jul

25,
29,
29,
21,
21,
27,
27,

1999

2001

2001

2004

2004

2004

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-202(of 347)

DISCONTINUED DRUG PRODUCT LIST

KETOROLAC TROMETHAMINE

INJECTABLE;INJECTION

KETOROLAC TROMETHAMINE

HIKMA MAPLE
HOSPIRA
LUITPOLD
SANDOZ
SUN PHARMA GLOBAL
WOCKHARDT
TORADOL

ROCHE PALO
SOLUTION/DROPS;OPHTHALMIC

ACULAR PRESERVATIVE FREE

ALLERGAN
KETOROLAC TROMETHAMINE

AKORN
TABLET;ORAL

KETOROLAC TROMETHAMINE

CYCLE PHARMS LTD
WATSON LABS
TORADOL

ROCHE PALO

15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
15MG/ML
30MG/ML
30MG/ML

A075299
A075299
A074801
A074801
A078145
A078145
A076271
A078737
A078737
A077943

001
002
001
002
001
002
001
001
002
001

Nov
Nov
Jun
Jun
Jan
Jan
Oct
Oct
Oct
Mar

03,
03,
05,
05,
14,
14,
06,
06,
06,
27,

1999

1999

1997

1997

2008

2008

2004

2008

2008

2007

15MG/ML
30MG/ML

N019698 001 Nov 30, 1989

N019698 002 Nov 30, 1989

0.5%

N020811 001 Nov 03, 1997

0.45%

A203376 001 Feb 10, 2014

10MG
10MG

A074790 001 Jun 26, 1997

A074955 001 Sep 19, 1997

10MG

N019645 001 Dec 20, 1991

KETOTIFEN FUMARATE

SOLUTION/DROPS;OPHTHALMIC

KETOTIFEN FUMARATE

APOTEX INC

EQ 0.025% BASE

A077354 001 May 09, 2006

KRYPTON, KR-81M

GAS;INHALATION

MPI KRYPTON 81M GENERATOR

GE HEALTHCARE

N/A

N018088 001

5MG/ML
5MG/ML
5MG/ML

A075355 001 Nov 29, 1999

A076051 001 Jul 05, 2002

A075242 001 Sep 30, 1999

5MG/ML

N018686 001 Aug 01, 1984

5MG/ML

N019425 001 Dec 31, 1985

100MG
200MG
300MG
100MG
200MG
300MG

A075223
A075223
A075223
A074989
A074989
A074989

001
002
003
001
002
003

Nov
Nov
Nov
Sep
Sep
Sep

20,
20,
20,
30,
30,
30,

1998

1998

1998

1998

1998

1998

100MG
200MG
300MG
400MG

N018687
N018687
N018687
N018687

001
002
003
004

Aug
Aug
Aug
Aug

31,
01,
01,
01,

1987

1984

1984

1984

400MG

N018716 004 Aug 01, 1984

10GM/15ML

N017884 001

10GM/15ML

A072372 001 Mar 22, 1989

10GM/15ML

A073497 001 May 28, 1993

10GM/15ML

A075911 001 Feb 21, 2002

LABETALOL HYDROCHLORIDE

INJECTABLE;INJECTION

LABETALOL HYDROCHLORIDE

APOTHECON
CLARIS PHARMASERVICE
HOSPIRA
NORMODYNE

SCHERING
TRANDATE

PROMETHEUS LABS
TABLET;ORAL

LABETALOL HYDROCHLORIDE

APOTHECON

TEVA

NORMODYNE

SCHERING

TRANDATE

CNTY LINE PHARMS
LACTULOSE

SOLUTION;ORAL

CHRONULAC

SANOFI AVENTIS US
DUPHALAC

SOLVAY
EVALOSE

TEVA PHARMS
LACTULOSE

APOTEX INC

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-203(of 347)

DISCONTINUED DRUG PRODUCT LIST

LACTULOSE

SOLUTION;ORAL

LACTULOSE

MORTON GROVE
PACO
LAXILOSE

NOSTRUM LABS
SOLUTION;ORAL, RECTAL

ACILAC

NOSTRUM LABS
CEPHULAC

SANOFI AVENTIS US
GENERLAC

MORTON GROVE
HEPTALAC

TEVA PHARMS
LACTULOSE

APOTEX INC
PACO
ROXANE
SOLVAY
PORTALAC

SOLVAY

10GM/15ML

10GM/15ML

A071841 001 Sep 22, 1988

A073160 001 Aug 25, 1992

10GM/15ML

A073686 001 May 28, 1993

10GM/15ML

A073685 001 May 28, 1993

10GM/15ML

N017657 001

10GM/15ML

A071842 001 Sep 27, 1988

10GM/15ML

A073504 001 May 28, 1993

10GM/15ML

10GM/15ML

10GM/15ML

10GM/15ML

A076645
A072029
A073590
N017906

10GM/15ML

A072374 001 Mar 22, 1989

LAMIVUDINE; RALTEGRAVIR POTASSIUM

TABLET;ORAL

DUTREBIS

MERCK SHARP DOHME
150MG;EQ 300MG BASE

LAMOTRIGINE

TABLET;ORAL

LAMICTAL

GLAXOSMITHKLINE LLC
LAMOTRIGINE

ACTAVIS TOTOWA

HIKMA PHARMS

MATRIX LABS LTD

MYLAN

PHARMASCIENCE INC

ROXANE

SANDOZ

WOCKHARDT

TABLET, CHEWABLE;ORAL

LAMICTAL CD

GLAXOSMITHKLINE LLC
LAMOTRIGINE

SANDOZ

001 Jul 28, 2003

001 Aug 25, 1992

001 May 29, 1992

001

N206510 001 Feb 06, 2015

50MG

250MG

N020241 006 Dec 27, 1994

N020241 004 Dec 27, 1994

25MG

100MG

150MG

200MG

25MG

100MG

150MG

200MG

25MG

100MG

150MG

200MG

25MG

100MG

150MG

200MG

25MG

100MG

150MG

200MG

25MG

100MG

150MG

200MG

25MG

100MG

150MG

200MG

25MG

100MG

150MG

200MG

A078669
A078669
A078669
A078669
A078134
A078134
A078134
A078134
A078443
A078443
A078443
A078443
A077428
A077428
A077428
A077428
A078310
A078310
A078310
A078310
A077392
A077392
A077392
A077392
A078645
A078645
A078645
A078645
A078982
A078982
A078982
A078982

100MG

N020764 003 Aug 24, 1998

5MG

25MG

A078409 002 Jan 22, 2009

A078409 003 Jan 22, 2009

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

08,
08,
08,
08,
19,
19,
19,
19,
11,
11,
11,
11,
27,
27,
27,
27,
04,
04,
04,
04,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2011

2011

2011

2011

2011

2011

2011

2011

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-204(of 347)

DISCONTINUED DRUG PRODUCT LIST

LANSOPRAZOLE

FOR SUSPENSION, DELAYED RELEASE;ORAL

PREVACID
TAKEDA PHARMS NA
15MG/PACKET
30MG/PACKET
INJECTABLE;INTRAVENOUS
PREVACID IV
TAKEDA PHARMS NA
30MG/VIAL
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL
LANSOPRAZOLE
ANI PHARMS INC
15MG
30MG
LANSOPRAZOLE; NAPROXEN
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
PREVACID NAPRAPAC 250 (COPACKAGED)
TAKEDA PHARMS NA
15MG,N/A;N/A,250MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PREVACID NAPRAPAC 375 (COPACKAGED)
TAKEDA PHARMS NA
15MG,N/A;N/A,375MG
PREVACID NAPRAPAC 500 (COPACKAGED)
TAKEDA PHARMS NA
15MG,N/A;N/A,500MG
LANTHANUM CARBONATE
TABLET, CHEWABLE;ORAL
FOSRENOL
SHIRE LLC

EQ 250MG BASE

N021281 001 May 03, 2001

N021281 002 May 03, 2001

N021566 001 May 27, 2004

A078730 001 Oct 15, 2010

A078730 002 Oct 15, 2010

N021507 002 Nov 14, 2003

N021507 003 Nov 14, 2003

N021507 004 Nov 14, 2003

N021468 001 Oct 26, 2004

LAPYRIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX

SOLUTION;TOPICAL
VIRAC REX
CHESEBROUGH PONDS
0.5%;1.8%

N011914 001

LATANOPROST
SOLUTION/DROPS;OPHTHALMIC
LATANOPROST
APOTEX INC

0.005%

A077697 001 Mar 22, 2011

10MG
10MG
20MG
20MG

A077085
A077087
A077085
A077087

LEPIRUDIN RECOMBINANT
INJECTABLE;INJECTION
REFLUDAN
BAYER HLTHCARE

50MG/VIAL

N020807 001 Mar 06, 1998

LETROZOLE
TABLET;ORAL
LETROZOLE
ACTAVIS TOTOWA
IMPAX LABS
SYNTHON PHARMS

2.5MG
2.5MG
2.5MG

A090292 001 Jul 13, 2011

A091638 001 Jun 03, 2011
A090196 001 Jun 03, 2011

EQ 60MG BASE/VIAL

N008107 003 Jan 30, 1987

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A089352
A089353
A088939
A070480
A081224
N008107
N008107
N008107
N008107
A040262
A089628

LEFLUNOMIDE
TABLET;ORAL
LEFLUNOMIDE
SANDOZ

LEUCOVORIN CALCIUM
FOR SOLUTION;ORAL
LEUCOVORIN CALCIUM
HOSPIRA
INJECTABLE;INJECTION
LEUCOVORIN CALCIUM
ABIC
ABRAXIS PHARM
ELKINS SINN
HOSPIRA

PHARMACHEMIE
PHARMACHEMIE USA

3MG BASE/ML
50MG BASE/VIAL
50MG BASE/VIAL
50MG BASE/VIAL
100MG BASE/VIAL
3MG BASE/ML
50MG BASE/VIAL
100MG BASE/VIAL
350MG BASE/VIAL
350MG BASE/VIAL
50MG BASE/VIAL

001
001
002
002

001
001
001
001
001
001
002
004
005
001
001

Sep
Sep
Sep
Sep

13,
13,
13,
13,

2005
2005
2005
2005

Jun
Jun
Dec
Jan
Jun

01,
01,
01,
02,
03,

1988
1988
1986
1987
1994

May
Apr
Dec
Apr

23,
05,
15,
17,

1988
1989
1999
1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-205(of 347)

DISCONTINUED DRUG PRODUCT LIST

LEUCOVORIN CALCIUM

INJECTABLE;INJECTION

LEUCOVORIN CALCIUM

EQ 100MG BASE/VIAL
TEVA PARENTERAL
EQ 50MG BASE/VIAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE

HOSPIRA
EQ 10MG BASE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
LUITPOLD
EQ 50MG BASE/VIAL
TEVA PARENTERAL
EQ 10MG BASE/ML
WELLCOVORIN
GLAXOSMITHKLINE
EQ 5MG BASE/ML
EQ 25MG BASE/VIAL
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
TABLET;ORAL
LEUCOVORIN CALCIUM
COREPHARMA
EQ 5MG BASE
EQ 25MG BASE
PAR PHARM
EQ 5MG BASE
EQ 25MG BASE
PHARMACHEMIE
EQ 5MG BASE
EQ 25MG BASE
SANDOZ
EQ 15MG BASE
XANODYNE PHARM
EQ 5MG BASE
EQ 10MG BASE
EQ 15MG BASE
WELLCOVORIN
GLAXOSMITHKLINE
EQ 5MG BASE
EQ 25MG BASE
LEUPROLIDE ACETATE
IMPLANT;IMPLANTATION
VIADUR
ORTHO MCNEIL JANSSEN
INJECTABLE;INJECTION
LEUPROLIDE ACETATE
GENZYME
LUPRON
ABBVIE ENDOCRINE INC
LUPRON DEPOT
ABBVIE ENDOCRINE INC

A089915 001 Apr 17, 1997

A081278 001 Sep 28, 1993

A040147 001 Jun 25, 1997

A040338 001 Jan 31, 2001

A040332 001 Jun 28, 1999
A087439
A089833
A089465
A089834

001
001
001
001

Oct
Jan
Jan
Jan

19,
23,
23,
23,

1982
1989
1989
1989

A074544
A074544
A071600
A071598
A073099
A073101
A075327
N018459
A071962
A071104

001
002
001
001
001
001
001
001
001
001

Aug
Aug
Oct
Oct
Mar
Mar
Mar
Jan
Nov
Mar

28,
28,
14,
14,
28,
28,
24,
30,
19,
04,

1997
1997
1987
1987
1997
1997
1999
1986
1987
1987

N018342 001 Jul 08, 1983

N018342 002 Jul 08, 1983

EQ 65MG BASE

N021088 001 Mar 03, 2000

1MG/0.2ML

A075721 001 Nov 29, 2001

1MG/0.2ML

N019010 001 Apr 09, 1985

3.75MG/VIAL **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**

N020011 001 Oct 22, 1990

3.75MG/VIAL,7.5MG/VIAL;3.75MG/VIAL,7.5M
G/VIAL **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
7.5MG/VIAL,7.5MG/VIAL;7.5MG/VIAL,7.5MG/
VIAL **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N020263 003 Apr 16, 1993

LEVALLORPHAN TARTRATE
INJECTABLE;INJECTION
LORFAN
ROCHE

1MG/ML

N010423 001

LEVAMISOLE HYDROCHLORIDE
TABLET;ORAL
ERGAMISOL
JANSSEN PHARMA

EQ 50MG BASE

N020035 001 Jun 18, 1990

100MG/ML

A090187 001 Aug 05, 2011

250MG

A077408 001 Mar 02, 2009

LUPRON DEPOT-PED
ABBVIE ENDOCRINE INC

LEVETIRACETAM
SOLUTION;ORAL
LEVETIRACETAM
APOTEX INC
TABLET;ORAL
LEVETIRACETAM
ACTAVIS LABS FL INC

N020263 004 Apr 16, 1993

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6-206(of 347)

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LEVETIRACETAM

TABLET;ORAL

LEVETIRACETAM

500MG
750MG
MYLAN
250MG
500MG
750MG
1GM
SANDOZ
250MG
500MG
750MG
1GM
WATSON LABS INC
250MG
500MG
750MG
1GM
TABLET, EXTENDED RELEASE;ORAL

LEVETIRACETAM

SANDOZ
500MG
750MG
LEVOBETAXOLOL HYDROCHLORIDE

SUSPENSION/DROPS;OPHTHALMIC

BETAXON

ALCON PHARMS LTD
LEVOBUNOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

LEVOBUNOLOL HYDROCHLORIDE

APOTEX INC
LEVOBUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CHIROCAINE

PURDUE PHARMA LP

LEVOCABASTINE HYDROCHLORIDE

SUSPENSION/DROPS;OPHTHALMIC

LIVOSTIN

NOVARTIS
LEVOCARNITINE

INJECTABLE;INJECTION

LEVOCARNITINE

TEVA PHARMS USA
SOLUTION;ORAL

CARNITOR

SIGMA TAU

DOPAR

SHIRE

LARODOPA

ROCHE

TABLET;ORAL

DOPAR

SHIRE

002
003
001
002
003
004
001
002
003
004
002
003
004
001

Mar
Mar
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

02,
02,
10,
10,
10,
10,
15,
15,
15,
15,
15,
15,
15,
15,

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

A091668 001 Nov 01, 2012

A091668 002 Nov 01, 2012

EQ 0.5% BASE

N021114 001 Feb 23, 2000

0.25%
0.5%

A075473 001 Aug 03, 2000

A075475 001 Aug 03, 2000

EQ 2.5MG BASE/ML
EQ 5MG BASE/ML
EQ 7.5MG BASE/ML

N020997 001 Aug 05, 1999

N020997 002 Aug 05, 1999

N020997 003 Aug 05, 1999

EQ 0.05% BASE

N020219 001 Nov 10, 1993

200MG/ML

A075881 001 Mar 29, 2001

1GM/10ML

N018948 002 Apr 27, 1988

LEVOCETIRIZINE DIHYDROCHLORIDE

TABLET;ORAL

LEVOCETIRIZINE DIHYDROCHLORIDE

SANDOZ
5MG
LEVODOPA

CAPSULE;ORAL

BENDOPA

VALEANT PHARM INTL

A077408
A077408
A078731
A078731
A078731
A078731
A077324
A077324
A077324
A077324
A078797
A078797
A078797
A078797

A090486 001 Mar 26, 2013

100MG
250MG
500MG

N016948 003

N016948 001

N016948 002

100MG
250MG
500MG

N016913 003

N016913 001

N016913 002

100MG
250MG
500MG

N016912 002

N016912 001

N016912 006

250MG
500MG

N016913 004

N016913 005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

LEVODOPA

TABLET;ORAL

LARODOPA

ROCHE

LEVOFLOXACIN

INJECTABLE;INJECTION

LEVOFLOXACIN

AKORN

SOLUTION/DROPS;OPHTHALMIC

IQUIX

SANTEN

LEVOFLOXACIN

APOTEX INC

QUIXIN

SANTEN

TABLET;ORAL

LEVOFLOXACIN

WATSON LABS INC

LEVOLEUCOVORIN CALCIUM

SOLUTION;IV (INFUSION)

FUSILEV

SPECTRUM PHARMS

LEVOMEPROMAZINE

INJECTABLE;INJECTION

LEVOPROME

IMMUNEX

6-207(of 347)

100MG

250MG

500MG

N016912 005

N016912 003

N016912 004

EQ 500MG/20ML (EQ 25MG/ML)

EQ 750MG/30ML (EQ 25MG/ML)

A091644 001
Jun 20, 2011

A091644 002
Jun 20, 2011

1.5% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N021571 001
Mar 01, 2004

0.5%

A078282 001
Dec 20, 2010

0.5% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N021199 001
Aug 18, 2000

250MG

500MG

750MG

A201484 001
Nov 22, 2013

A201484 002
Nov 22, 2013

A201484 003
Nov 22, 2013

EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

N020140 002
Apr 29, 2011

20MG/ML

N015865 001

LEVOMETHADYL ACETATE HYDROCHLORIDE

CONCENTRATE;ORAL

ORLAAM

ROXANE
10MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

SOLVAY
0.05MG/ML;2%

CARBOCAINE W/ NEO-COBEFRIN

EASTMAN KODAK
0.05MG/ML;2%

ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

NOVOCOL
0.05MG/ML;2%

MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN

GRAHAM CHEM
0.05MG/ML;2%

POLOCAINE W/ LEVONORDEFRIN

DENTSPLY PHARM
0.05MG/ML;2%

LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN

EASTMAN KODAK
0.05MG/ML;2%;0.4%

N020140 003
Apr 29, 2011

N020315 001
Jul 09, 1993

A085010 001

N012125 002

A084697 001

A084850 002
Oct 21, 1983

A089517 001
Apr 14, 1988

N008592 007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-208(of 347)

DISCONTINUED DRUG PRODUCT LIST

LEVONORGESTREL

IMPLANT;IMPLANTATION

JADELLE

POPULATION COUNCIL

75MG/IMPLANT **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

LEVONORGESTREL

WYETH PHARMS INC
75MG/IMPLANT
NORPLANT

POPULATION COUNCIL
36MG/IMPLANT
NORPLANT SYSTEM IN PLASTIC CONTAINER

WYETH PHARMS INC
36MG/IMPLANT
TABLET;ORAL

LEVONORGESTREL

LUPIN LTD
0.75MG
WATSON LABS
0.75MG
PLAN B

TEVA BRANDED PHARM
0.75MG
LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS

CAPSULE;ORAL

NOVRAD

LILLY
EQ 50MG BASE
EQ 100MG BASE
SUSPENSION;ORAL

NOVRAD

LILLY
EQ 50MG BASE/5ML
LEVORPHANOL TARTRATE

INJECTABLE;INJECTION

LEVO-DROMORAN

VALEANT PHARM INTL
TABLET;ORAL

LEVO-DROMORAN

VALEANT PHARM INTL
LEVOTHYROXINE SODIUM

TABLET;ORAL

LEVOLET

VINTAGE

LEVOTHYROXINE SODIUM

MERCK KGAA

LEVOXYL

KING PHARMS R AND D
NOVOTHYROX

MERCK KGAA

N020544 001 Nov 01, 1996

N020627 001 Aug 15, 1996

N019897 001 Dec 10, 1990

N020088 001 Dec 10, 1990

A091328 001 Jan 23, 2013

A078666 001 Jun 24, 2009

N021045 001 Jul 28, 1999

N012928 006

N012928 004

N012928 002

2MG/ML

N008719 001 Dec 19, 1991

2MG

N008720 001 Dec 19, 1991

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG

N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137

001
002
003
004
005
006
007
008
009
010
011
012

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.15MG
0.175MG
0.2MG
0.3MG

A076752
A076752
A076752
A076752
A076752
A076752
A076752
A076752
A076752
A076752
A076752

001
002
003
004
005
006
007
008
009
010
011

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,

2005

2005

2005

2005

2005

2005

2005

2005

2005

2005

2005

0.3MG

N021301 012 May 25, 2001

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG

N021292
N021292
N021292
N021292
N021292
N021292
N021292

001
002
003
004
005
006
007

May
May
May
May
May
May
May

31,
31,
31,
31,
31,
31,
31,

2002

2002

2002

2002

2002

2002

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-209(of 347)

DISCONTINUED DRUG PRODUCT LIST

LEVOTHYROXINE SODIUM

TABLET;ORAL

NOVOTHYROX

0.137MG

0.15MG

0.175MG

0.2MG

0.3MG

LIDOCAINE

AEROSOL;ORAL

XYLOCAINE

ASTRAZENECA

10%

FILM, EXTENDED RELEASE;BUCCAL

DENTIPATCH

NOVEN

23MG/PATCH

OINTMENT;TOPICAL

ALPHACAINE

CARLISLE

5%

5%

5%

LIDOCAINE

BELMORA LLC

5%

XYLOCAINE

ASTRAZENECA

5%

PATCH;TOPICAL

DENTIPATCH

NOVEN

46.1MG/PATCH

SOLUTION;TOPICAL

XYLOCAINE

ASTRAZENECA

5%

SUPPOSITORY;RECTAL

XYLOCAINE

ASTRAZENECA

100MG

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

ALPHACAINE HYDROCHLORIDE

CARLISLE

LIDOCAINE HYDROCHLORIDE

ABBOTT

ABRAXIS PHARM

AKORN

BEL MAR

DELL LABS

ELKINS SINN

EUROHLTH INTL SARL

GD SEARLE LLC

GRAHAM CHEM

HOSPIRA

INTL MEDICATION

LUITPOLD

LYPHOMED

N021292
N021292
N021292
N021292
N021292

008
009
010
011
012

May
May
May
May
May

31,
31,
31,
31,
31,

2002

2002

2002

2002

2002

N014394 001

N020575 001 May 21, 1996

A084944 001

A084946 001

A084947 001

A080210 001

N008048 001

N020575 002 May 21, 1996

N014127 001

N013077 001

2%

A084721 001

10%

20%

1%

1%

1.5%

2%

2%

2%

2%

4%

20%

1%

2%

1%

2%

1%

2%

0.5%

4%

1%

2%

1%

2%

2%

1%

1.5%

2%

1%

2%

1GM/VIAL

2GM/VIAL

2%

1%

A087980
A089362
A080420
A086761
A080420
A080420
A080420
A086761
N017508
N017508
N017508
A085037
A085037
A080710
A080760
A083387
A083388
A085131
A084626
A080407
A080407
A083135
A083135
A080504
A040013
A088330
A088331
N017701
N017701
N018543
N018543
A083198
A080390

001
001
001

001

005

002

004

002

001

002

004

001

002

001

001

001

001

001

001

001

002

001

002

001

001
001
001
002

001

001

002

001

001

Feb 02, 1983

May 25, 1988

Jun 23, 1995

May 17, 1984

May 17, 1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-210(of 347)

DISCONTINUED DRUG PRODUCT LIST

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE

2%

1%

2%

WATSON LABS
1%

1%

2%

2%

WYETH AYERST
1%

2%

LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
100MG/100ML

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
200MG/100ML

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%

HOSPIRA
200MG/100ML

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT
200MG/100ML

HOSPIRA
200MG/100ML

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
400MG/100ML

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

HOSPIRA
400MG/100ML

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
800MG/100ML

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

HOSPIRA
1.5%

10%

20%

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

EUROHLTH INTL SARL

1%

2%

INTL MEDICATION

4%

LIDOCATON

PHARMATON

2%

LIDOPEN

MERIDIAN MEDCL TECHN
10%

XYLOCAINE

ASTRAZENECA

1%

1.5%

2%

XYLOCAINE DENTAL

DENTSPLY PHARM

2%

XYLOCAINE PRESERVATIVE FREE

FRESENIUS KABI USA

10%

INJECTABLE;SPINAL

XYLOCAINE 1.5% W/ DEXTROSE 7.5%

FRESENIUS KABI USA

1.5%

XYLOCAINE 5% W/ GLUCOSE 7.5%

ASTRAZENECA
5%

JELLY;TOPICAL

ANESTACON

BANNER LIFE SCIENCES
2%

LIDOCAINE HYDROCHLORIDE

G AND W LABS INC
2%

SOLUTION;ORAL

LIDOCAINE HYDROCHLORIDE VISCOUS

ACTAVIS MID ATLANTIC
2%

INTL MEDICATION
2%

SOLUTION;TOPICAL

LARYNGOTRACHEAL ANESTHESIA KIT

KENDALL IL
4%

LIDOCAINE HYDROCHLORIDE

PACO
4%

LTA II KIT

HOSPIRA
4%

PEDIATRIC LTA KIT

ABBOTT
2%

HOSPIRA
2%

MILES

A080390
A080414
A080414
A080377
A083627
A080377
A083627
A083083
A083083

002

001

002

001

001

002

002

001

002

N018461 001

N018967 001 Mar 30, 1984

A083158 005

N018954 001 Jul 09, 1985

N018388 001

N018967 002 Mar 30, 1984

A083158 006

N018967 003 Mar 30, 1984

A088326 001 Jul 31, 1984

A088367 001 Jul 31, 1984

A088368 001 Jul 31, 1984

A084625 001

A084625 002

N017702 002

A084727 001 Aug 17, 1983

N017549 001

N010418 005

N010418 009

N010418 007

N021380 001

N016801 003

N016297 001

N010496 002 Jul 07, 1982

A080429 001

A081318 001 Apr 29, 1993

A086578 001

A086389 001 Feb 02, 1982

A087931 001 Jun 10, 1983

A089688 001 Jun 30, 1989

A088542 001 Jul 31, 1984

A088572 001 Jul 31, 1984

A085995 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-211(of 347)

DISCONTINUED DRUG PRODUCT LIST

LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE

INJECTABLE;INJECTION

TERRAMYCIN

PFIZER
2%;50MG/ML

2%;125MG/ML

A060567 001

A060567 002

LIDOCAINE; PRILOCAINE

DISC;TOPICAL

EMLA

ASTRAZENECA

2.5%;2.5%

N020962 001 Feb 04, 1998

EQ 250MG BASE

EQ 500MG BASE

N050316 001

N050316 002

EQ 300MG BASE/ML

A063180 001 Apr 16, 1991

1%

1%

A084218 001

N006309 001

1%

A084989 001

1%

1%

A084218 002

N006309 003

1%

A086769 001

1%

A084988 001

1%

1%

A084219 001

N010718 001

1%

A087940 001 Apr 08, 1983

400MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N021130 001 Apr 18, 2000

EQ 0.025MG BASE

EQ 0.05MG BASE

A085755 001 Jan 25, 1982

A085753 001 Feb 03, 1982

0.0075MG;0.0075MG

N016680 001

0.015MG;0.015MG

N016680 002

0.03MG;0.03MG

N016680 003

0.045MG;0.045MG

N016680 004

0.0625MG;0.25MG

N016807 006

2.5MG

2.5MG

5MG

5MG

A075903
A075999
A075903
A075999

LINCOMYCIN HYDROCHLORIDE

CAPSULE;ORAL

LINCOCIN

PHARMACIA AND UPJOHN
INJECTABLE;INJECTION

LINCOMYCIN HYDROCHLORIDE

WATSON LABS
LINDANE

CREAM;TOPICAL

KWELL

REED AND CARNRICK
LOTION;TOPICAL

GAMENE

SOLA BARNES HIND
KWELL

REED AND CARNRICK
SCABENE

STIEFEL
SHAMPOO;TOPICAL

GAMENE

SOLA BARNES HIND
KWELL

REED AND CARNRICK
SCABENE

STIEFEL
LINEZOLID

TABLET;ORAL

ZYVOX

PHARMACIA AND UPJOHN

LIOTHYRONINE SODIUM

TABLET;ORAL

LIOTHYRONINE SODIUM

WATSON LABS
LIOTRIX (T4;T3)

TABLET;ORAL

EUTHROID-0.5

PARKE DAVIS
EUTHROID-1

PARKE DAVIS
EUTHROID-2

PARKE DAVIS
EUTHROID-3

PARKE DAVIS
THYROLAR-5

FOREST LABS
LISINOPRIL

TABLET;ORAL

LISINOPRIL

SANDOZ

001
001
002
002

Jul
Jul
Jul
Jul

01,
01,
01,
01,

2002

2002

2002

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-212(of 347)

DISCONTINUED DRUG PRODUCT LIST

LISINOPRIL

TABLET;ORAL

LISINOPRIL

TEVA

PRINIVIL

MERCK
LITHIUM CARBONATE

CAPSULE;ORAL

ESKALITH

NOVEN THERAP
LITHIUM CARBONATE

ABLE

10MG
10MG
20MG
20MG
30MG
30MG
40MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG

A075903
A075999
A075903
A075999
A075903
A075999
A075903
A075999
A075783
A075783
A075783
A075783
A075783
A075783

2.5MG

N019558 006 Jan 28, 1994

300MG

N016860 001

150MG
300MG
300MG
600MG
300MG
600MG
300MG
300MG

A076823
A076121
A076823
A076823
A076795
A078763
A072542
A070407

APOTEX INC
HIKMA PHARMS LLC
USL PHARMA
WATSON LABS
LITHONATE

SOLVAY
300MG
TABLET;ORAL

ESKALITH

JDS PHARMS
300MG
LITHANE

BAYER PHARMS
300MG
LITHIUM CARBONATE

HIKMA INTL PHARMS
300MG
PFIZER
300MG
LITHOTABS

SOLVAY
300MG
TABLET, EXTENDED RELEASE;ORAL

ESKALITH CR

JDS PHARMS
450MG
LITHIUM CARBONATE

ABLE
300MG
BARR
300MG
450MG
HIKMA INTL PHARMS
450MG

003
003
004
004
005
005
006
006
001
002
003
004
005
006

001
001
002
003
001
001
001
001

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

Jun
Sep
Jun
Jun
Nov
Apr
Feb
Mar

01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

29,
27,
29,
29,
22,
15,
01,
19,

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

2004

2001

2004

2004

2004

2008

1989

1987

N016782 001

N017971 001

N018833 001 Jul 18, 1985

A078715 001 Dec 28, 2010

N016834 001

N016980 001

N018152 001 Mar 29, 1982

A076382
A076170
A076366
A076490

001
001
001
001

Apr
Jun
Aug
Jun

21,
10,
21,
17,

2003

2002

2003

2003

LITHIUM CITRATE

SYRUP;ORAL

LITHONATE

SOLVAY

EQ 300MG CARBONATE/5ML

N017672 001

LOMEFLOXACIN HYDROCHLORIDE

TABLET;ORAL

MAXAQUIN

PHARMACIA

EQ 400MG BASE

N020013 001 Feb 21, 1992

2MG

N017690 001

2MG
2MG
2MG

A073080 001 Nov 27, 1991

A072993 001 Aug 28, 1992

A073122 001 Aug 30, 1991

LOPERAMIDE HYDROCHLORIDE

CAPSULE;ORAL

IMODIUM

J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE

ROXANE
SANDOZ
TEVA

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-213(of 347)

DISCONTINUED DRUG PRODUCT LIST

LOPERAMIDE HYDROCHLORIDE

SOLUTION;ORAL

IMODIUM

JANSSEN PHARMS
LOPERAMIDE HYDROCHLORIDE

ALPHARMA US PHARMS
DURAMED PHARMS BARR
TEVA
WATSON LABS
TABLET;ORAL

LOPERAMIDE HYDROCHLORIDE

ABLE
PERRIGO
LOPINAVIR; RITONAVIR

CAPSULE;ORAL

KALETRA

ABBVIE
LORACARBEF

CAPSULE;ORAL

LORABID

KING PHARMS
FOR SUSPENSION;ORAL

LORABID

KING PHARMS
LORATADINE

SYRUP;ORAL

CLARITIN HIVES RELIEF

BAYER HEALTHCARE LLC

LORATADINE

APOTEX INC
RANBAXY LABS LTD
TABLET;ORAL

LORATADINE

PERRIGO

1MG/5ML

N019037 001 Jul 31, 1984

1MG/5ML
1MG/5ML
1MG/5ML
1MG/5ML

A073187
A074991
A073478
A073062

2MG
2MG

A073528 001 Nov 30, 1993

A074194 001 Oct 30, 1992

133.3MG;33.3MG

N021226 001 Sep 15, 2000

200MG
400MG

N050668 001 Dec 31, 1991

N050668 002 Apr 05, 1996

100MG/5ML
200MG/5ML

N050667 001 Dec 31, 1991

N050667 002 Dec 31, 1991

1MG/ML **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N020641 003 Nov 19, 2003

1MG/ML
1MG/ML

A075565 001 Oct 05, 2004

A076529 001 Aug 20, 2004

10MG

N021512 001 Jun 24, 2004

LORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

LORATADINE AND PSEUDOEPHEDRINE SULFATE

ACTAVIS LABS FL INC
5MG;120MG
LORAZEPAM

INJECTABLE;INJECTION

LORAZEPAM

AKORN
BEDFORD
DAVA PHARMS INC
HIKMA MAPLE
HOSPIRA

WATSON LABS
WATSON LABS INC

SOLUTION;ORAL

LORAZEPAM

ROXANE
TABLET;ORAL

LORAZ

QUANTUM PHARMICS

001
001
001
001

Sep
Dec
Jun
May

15,
29,
23,
28,

1992

1997

1995

1993

A076208 001 Jan 28, 2004

2MG/ML
2MG/ML
4MG/ML
2MG/ML
4MG/ML
2MG/ML
4MG/ML
2MG/ML
2MG/ML
4MG/ML
4MG/ML
2MG/ML
4MG/ML
1MG/0.5ML
2MG/ML
2MG/ML
4MG/ML
4MG/ML

A074974
A077076
A077076
A074793
A074793
A074496
A074496
A074280
A074300
A074280
A074300
A074276
A074276
A074551
A074535
A074551
A074535
A074551

001
001
002
001
002
001
002
001
001
002
003
001
002
003
001
001
002
002

Jul
Jul
Jul
Mar
Mar
Sep
Sep
May
Apr
May
Mar
Apr
Apr
Sep
Sep
Sep
Sep
Sep

23,
13,
13,
16,
16,
28,
28,
27,
12,
27,
19,
15,
15,
12,
12,
12,
12,
12,

1998

2005

2005

2000

2000

1998

1998

1994

1994

1994

1997

1994

1994

1996

1996

1996

1996

1996

0.5MG/5ML

A074648 001 Mar 18, 1997

0.5MG

A070200 001 Aug 09, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-214(of 347)

DISCONTINUED DRUG PRODUCT LIST

LORAZEPAM

TABLET;ORAL

LORAZ

1MG
2MG

A070201 001 Aug 09, 1985

A070202 001 Aug 09, 1985

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
0.5MG
1MG
1MG
2MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
1MG
2MG
1MG
2MG
0.5MG
0.5MG
1MG
1MG
2MG
2MG

A070727
A070728
A070729
A071434
A071435
A071436
A070472
A072553
A070473
A072554
A070474
A072555
A070675
A070676
A070677
A071193
A071194
A071195
A071245
A071246
A071247
A070539
A070540
A071038
A071039
A071086
A071117
A071087
A071118
A071088
A071110

0.5%

N020841 001 Mar 09, 1998

10MG
20MG
40MG
TABLET, EXTENDED RELEASE;ORAL

ALTOPREV

COVIS PHARMA SARL
10MG

N019643 002 Mar 28, 1991

N019643 003 Aug 31, 1987

N019643 004 Dec 14, 1988

LORAZEPAM

AM THERAP

HALSEY

MUTUAL PHARM

PAR PHARM

SANDOZ

SUPERPHARM

USL PHARMA
WARNER CHILCOTT
WATSON LABS

LOTEPREDNOL ETABONATE

SUSPENSION/DROPS;OPHTHALMIC

LOTEMAX

PHARMOS
LOVASTATIN

TABLET;ORAL

MEVACOR

MERCK

LOXAPINE HYDROCHLORIDE

CONCENTRATE;ORAL

LOXITANE C

ACTAVIS LABS UT INC
INJECTABLE;INJECTION

LOXITANE IM

ACTAVIS LABS UT INC
LOXAPINE SUCCINATE

CAPSULE;ORAL

LOXITANE

ACTAVIS LABS UT INC

TABLET;ORAL

LOXITANE

ACTAVIS LABS UT INC

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

N017658 001

EQ 50MG BASE/ML

N018039 001

EQ
EQ
EQ
EQ

N017525
N017525
N017525
N017525

EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE

07,
07,
07,
01,
01,
01,
10,
29,
10,
29,
10,
29,
01,
01,
01,
15,
15,
15,
09,
09,
09,
22,
22,
12,
12,
23,
24,
23,
24,
23,
24,

1986

1986

1986

1987

1987

1987

1985

1991

1985

1991

1985

1991

1986

1986

1986

1988

1988

1988

1987

1987

1987

1986

1986

1988

1988

1987

1986

1987

1986

1987

1986

N021316 001 Jun 26, 2002

EQ 25MG BASE/ML

5MG BASE
10MG BASE
25MG BASE
50MG BASE

Mar
Mar
Mar
Sep
Sep
Sep
Dec
Mar
Dec
Mar
Dec
Mar
Dec
Dec
Dec
Apr
Apr
Apr
Feb
Feb
Feb
Dec
Dec
Jan
Jan
Mar
Jul
Mar
Jul
Mar
Jul

001

002

003

004

N017525 006

N017525 007

N017525 008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-215(of 347)

DISCONTINUED DRUG PRODUCT LIST

LUCINACTANT
SUSPENSION;INTRATRACHEAL
SURFAXIN
DISCOVERY LABS

8.5ML

N021746 001 Mar 06, 2012

LUTROPIN ALFA
INJECTABLE;SUBCUTANEOUS
LUVERIS
EMD SERONO

75 IU/VIAL

N021322 001 Oct 08, 2004

LYPRESSIN
SOLUTION;NASAL
DIAPID
NOVARTIS

0.185MG/ML

N016755 001

MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

PLASMA-LYTE 56 IN PLASTIC CONTAINER

BAXTER HLTHCARE
32MG/100ML;128MG/100ML;234MG/100ML

N019047 001 Jun 15, 1984

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

INJECTABLE;INJECTION

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER

B BRAUN
30MG/100ML;37MG/100ML;0.82MG/100ML;370M
N019006 001 Apr 04, 1984

G/100ML;530MG/100ML;500MG/100ML;12MG/10

0ML

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

INJECTABLE;INJECTION
ISOLYTE S IN PLASTIC CONTAINER
B BRAUN
30MG/100ML;37MG/100ML;370MG/100ML;530MG
N018252 001
/100ML;500MG/100ML
SOLUTION;IRRIGATION
PHYSIOSOL IN PLASTIC CONTAINER
HOSPIRA INC
14MG/100ML;37MG/100ML;222MG/100ML;526MG
N018406 001
/100ML;502MG/100ML
PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER
HOSPIRA INC
30MG/100ML;37MG/100ML;222MG/100ML;526MG
N018406 002 Jul 08, 1982
/100ML;502MG/100ML
SYNOVALYTE IN PLASTIC CONTAINER
BAXTER HLTHCARE
30MG/100ML;37MG/100ML;368MG/100ML;526MG
N019326 001 Jan 25, 1985
/100ML;502MG/100ML
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE
TABLET;ORAL
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
SANTARUS
343MG;20MG;750MG
343MG;40MG;750MG
TABLET, CHEWABLE;ORAL
ZEGERID
SANTARUS
700MG;20MG;600MG
700MG;40MG;600MG

N022456 001 Dec 04, 2009

N022456 002 Dec 04, 2009

N021850 001 Mar 24, 2006

N021850 002 Mar 24, 2006

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM

BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE

SOLUTION;ORAL
SUCLEAR
BRAINTREE LABS
1.6GM;210GM;0.74GM;3.13GM;2.86GM;5.6GM;
N203595 001 Jan 18, 2013
17.5GM
MALATHION
LOTION;TOPICAL
MALATHION
MYLAN PHARMS INC

0.5%

A078743 001 Mar 06, 2009

MANGAFODIPIR TRISODIUM
INJECTABLE;INJECTION
TESLASCAN
GE HEALTHCARE

37.9MG/ML

N020652 001 Nov 26, 1997

MANGANESE CHLORIDE TETRAHYDRATE

FOR SOLUTION;ORAL
LUMENHANCE
BRACCO
3.49MG/GM

N020686 001 Dec 19, 1997

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6-216(of 347)

DISCONTINUED DRUG PRODUCT LIST

MANGANESE SULFATE

INJECTABLE;INJECTION

MANGANESE SULFATE

ABRAXIS PHARM

EQ 0.1MG MANGANESE/ML

MANNITOL

INJECTABLE;INJECTION

MANNITOL 10%

B BRAUN
10GM/100ML

HOSPIRA
10GM/100ML

MILES
10GM/100ML

MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER

B BRAUN
10GM/100ML

MANNITOL 15%

B BRAUN
15GM/100ML

HOSPIRA
15GM/100ML

MILES
15GM/100ML

MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%

B BRAUN

15GM/100ML

MANNITOL 20%

B BRAUN

20GM/100ML

20GM/100ML

HOSPIRA

20GM/100ML

MILES

20GM/100ML

MANNITOL 25%

ABRAXIS PHARM

12.5GM/50ML

HOSPIRA

12.5GM/50ML

IGI LABS INC

12.5GM/50ML

12.5GM/50ML

MERCK

12.5GM/50ML

WATSON LABS

12.5GM/50ML

MANNITOL 5%

B BRAUN

5GM/100ML

HOSPIRA

5GM/100ML

MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

B BRAUN

5GM/100ML

POWDER;INHALATION

ARIDOL KIT

PHARMAXIS LTD

N/A,5MG,10MG,20MG,40MG

SOLUTION;IRRIGATION

RESECTISOL

B BRAUN

5GM/100ML

MANNITOL; SORBITOL

SOLUTION;IRRIGATION

SORBITOL-MANNITOL

HOSPIRA

540MG/100ML;2.7GM/100ML

SORBITOL-MANNITOL IN PLASTIC CONTAINER

HOSPIRA

540MG/100ML;2.7GM/100ML

MAPROTILINE HYDROCHLORIDE

TABLET;ORAL

LUDIOMIL

NOVARTIS

MAPROTILINE HYDROCHLORIDE

AM THERAP

WATSON LABS

MASOPROCOL

CREAM;TOPICAL

ACTINEX

UNIV AZ CANCER CTR

N019228 001 May 05, 1987

N016080 002

N016269 002

N016472 002

N016080 006

N016080 003

N016269 003

N016472 005

N016080 005

N014738
N016080
N016269
N016472

001

004

004

004

A086754
N016269
A089239
A089240
N005620
A087460

001

005

001 May 06, 1987

001 May 06, 1987

001

001 Jun 27, 1983

N016080 001

N016269 001

N016080 007

N022368 001 Oct 05, 2010

N016704 002

A080224 001

N017636 001

25MG

50MG

75MG

N017543 001

N017543 002

N017543 003 Sep 30, 1982

25MG

50MG

75MG

25MG

25MG

50MG

50MG

75MG

75MG

A072129
A072130
A072131
A071943
A072162
A071944
A072163
A071945
A072164

10%

N019940 001 Sep 04, 1992

001
001
001
001
001
001
001
001
001

Jan
Jan
Jan
Dec
Jun
Dec
Jun
Dec
Jun

14,
14,
14,
30,
01,
30,
01,
30,
01,

1988

1988

1988

1987

1988

1987

1988

1987

1988

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6-217(of 347)

DISCONTINUED DRUG PRODUCT LIST

MAZINDOL

TABLET;ORAL

MAZANOR

WYETH AYERST

1MG
2MG

N017980 002

N017980 001

1MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

2MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N017247 001

MEBENDAZOLE

TABLET, CHEWABLE;ORAL

VERMOX

JANSSEN PHARMS

100MG

N017481 001

MEBUTAMATE

TABLET;ORAL

DORMATE

MEDPOINTE PHARM HLC

600MG

N017374 001

MECAMYLAMINE HYDROCHLORIDE

TABLET;ORAL

INVERSINE

TARGACEPT

2.5MG

N010251 001

SANOREX

NOVARTIS

MECASERMIN RINFABATE RECOMBINANT

INJECTABLE;SUBCUTANEOUS

IPLEX
INSMED
36MG/0.6ML
MECLIZINE HYDROCHLORIDE
TABLET;ORAL
ANTIVERT
CITRON PHARMA LLC

MECLIZINE HYDROCHLORIDE
ABC HOLDING
AMNEAL PHARMS
ANABOLIC
ANI PHARMS INC
BUNDY
IVAX SUB TEVA PHARMS
KV PHARM
MYLAN PHARMS INC
PAR PHARM
PLIVA
SUPERPHARM
UDL
VANGARD
VINTAGE PHARMS
WATSON LABS

TABLET, CHEWABLE;ORAL
ANTIVERT
CITRON PHARMA LLC
MECLIZINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS
NEXGEN PHARMA INC
PLIVA

N017247 002

N021884 001 Dec 12, 2005

12.5MG
25MG
50MG

N010721 006
N010721 004
N010721 001 Jan 20, 1982

12.5MG
25MG
50MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
12.5MG
25MG
50MG
50MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
12.5MG
25MG

A085253
A085252
A201451
A085891
A084975
A084657
A084382
A084872
A083784
A085524
A085523
A202640
A089674
A088732
A088734
A089113
A089114
A088256
A088257
A087877
A087620
A040179
A040179
A085195
A085269
A085740

25MG

N010721 005

25MG
25MG
25MG

A084976 001
A086392 001
A088733 001 Dec 11, 1985

001
001
003
001
001
001
001
001
001
001
001
003
001
001
001
001
001
001
001
001
001
001
002
001
001
001

Feb 23, 2011

Sep
Mar
Dec
Dec
Aug
Aug
Jun
Jun
Apr
Jan
Jan
Jan

17,
31,
11,
11,
20,
20,
13,
13,
20,
04,
30,
30,

2012
1988
1985
1985
1985
1985
1983
1983
1982
1982
1997
1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-218(of 347)

DISCONTINUED DRUG PRODUCT LIST

MECLOCYCLINE SULFOSALICYLATE

CREAM;TOPICAL

MECLAN

JOHNSON AND JOHNSON
MECLOFENAMATE SODIUM

CAPSULE;ORAL

MECLODIUM

QUANTUM PHARMICS
MECLOFENAMATE SODIUM

AM THERAP
BARR
PAR PHARM
SANDOZ
USL PHARMA
VITARINE
WATSON LABS

MECLOMEN

PARKE DAVIS
MEDROXYPROGESTERONE ACETATE

INJECTABLE;INJECTION

DEPO-PROVERA

PHARMACIA AND UPJOHN

1%

N050518 001

EQ 50MG BASE
EQ 100MG BASE

A071380 001 Jul 14, 1987

A071381 001 Jul 14, 1987

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A071362
A071363
A072848
A072809
A072077
A072078
A072262
A072263
A071007
A071008
A071710
A071684
A070400
A071468
A071640
A070401
A071469
A071641

50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
50MG BASE
50MG BASE
100MG BASE
100MG BASE
100MG BASE

EQ 50MG BASE
EQ 100MG BASE

N018006 001

N018006 002

100MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N012541 002

MEDROXYPROGESTERONE ACETATE

TEVA PHARMS USA
150MG/ML
TABLET;ORAL

AMEN

AMARIN PHARMS
10MG
CURRETAB

SOLVAY
10MG
CYCRIN

ESI
2.5MG
5MG
10MG
MEDROXYPROGESTERONE ACETATE

DURAMED PHARMS BARR
2.5MG
5MG
10MG
USL PHARMA
10MG
MEDRYSONE

SUSPENSION;OPHTHALMIC

HMS

ALLERGAN
MEFLOQUINE HYDROCHLORIDE

TABLET;ORAL

LARIAM

ROCHE
MEFLOQUINE HYDROCHLORIDE

HIKMA PHARMS LLC
US ARMY WALTER REED

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Feb
Feb
Mar
Mar
Mar
Mar
Nov
Nov
Mar
Mar
Jun
Jun
Nov
Apr
Aug
Nov
Apr
Aug

10,
10,
20,
20,
10,
10,
29,
29,
25,
25,
15,
15,
25,
15,
11,
25,
15,
11,

1987

1987

1989

1989

1988

1988

1988

1988

1988

1988

1988

1988

1986

1987

1987

1986

1987

1987

A076552 001 Oct 27, 2004

A083242 001

A085686 001

A081239 001 Oct 30, 1992

A081240 001 Oct 30, 1992

A089386 001 Sep 09, 1987

A040311
A040311
A040311
A088484

001
002
003
001

Dec
Dec
Dec
Jul

01,
01,
01,
26,

1999

1999

1999

1984

1%

N016624 003

250MG

N019591 001 May 02, 1989

250MG
250MG

A077699 001 Apr 21, 2010

N019578 001 May 02, 1989

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6-219(of 347)

DISCONTINUED DRUG PRODUCT LIST

MEGESTROL ACETATE

SUSPENSION;ORAL

MEGESTROL ACETATE

APOTEX INC
TABLET;ORAL

MEGACE

BRISTOL MYERS SQUIBB
MEGESTROL ACETATE

TEVA
USL PHARMA
MELOXICAM

TABLET;ORAL

MELOXICAM

COREPHARMA
CR DOUBLE CRANE
MUTUAL PHARM
MYLAN
ROXANE
YABAO PHARM
MELPHALAN HYDROCHLORIDE

INJECTABLE;INJECTION

MELPHALAN HYDROCHLORIDE

MYLAN INSTITUTIONAL
MEMANTINE HYDROCHLORIDE

TABLET;ORAL

MEMANTINE HYDROCHLORIDE

ORCHID HLTHCARE
MENADIOL SODIUM DIPHOSPHATE

INJECTABLE;INJECTION

KAPPADIONE

LILLY
SYNKAYVITE

ROCHE

TABLET;ORAL

SYNKAYVITE

ROCHE
MENADIONE

TABLET;ORAL

MENADIONE

LILLY
MENOTROPINS (FSH;LH)

INJECTABLE;INJECTION

HUMEGON

ORGANON USA INC
MENOTROPINS

FERRING
PERGONAL

SERONO

40MG/ML

A077404 001 Feb 16, 2006

20MG
40MG

N016979 001

N016979 002

40MG
20MG
40MG

A074745 001 Feb 27, 1998

A070646 001 Oct 02, 1987

A070647 001 Oct 02, 1987

7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG

A077930
A077930
A078039
A078039
A077935
A077935
A077934
A077934
A077925
A077925
A077933
A077933

EQ 50MG BASE/VIAL

A090299 001 Oct 27, 2009

5MG
10MG

A090044 001 Mar 12, 2012

A090044 002 Mar 12, 2012

10MG/ML

N005725 001

5MG/ML
10MG/ML
37.5MG/ML

N003718 004

N003718 006

N003718 008

5MG

N003718 010

5MG

N002139 003

75 IU/VIAL;75 IU/VIAL
150 IU/VIAL;150 IU/VIAL

N020328 001 Sep 01, 1994

N020328 002 Sep 01, 1994

75 IU/VIAL;75 IU/VIAL
150 IU/VIAL;150 IU/VIAL

A073598 001 Jan 30, 1997

A073599 001 Jan 30, 1997

75 IU/AMP;75 IU/AMP
150 IU/AMP;150 IU/AMP

N017646 001

N017646 002 May 20, 1985

REPRONEX

FERRING
150 IU/VIAL;150 IU/VIAL
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
REPRONEX
FERRING
75 IU/VIAL;75 IU/VIAL

001
002
001
002
001
002
001
002
001
002
001
002

Jul
Jul
Dec
Dec
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

19,
19,
14,
14,
19,
19,
20,
20,
19,
19,
19,
19,

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

2006

N021047 002 Aug 27, 1999

N021047 001 Aug 27, 1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-220(of 347)

DISCONTINUED DRUG PRODUCT LIST

MEPENZOLATE BROMIDE

SOLUTION;ORAL

CANTIL

SANOFI AVENTIS US

MEPERIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

DEMEROL

SANOFI AVENTIS US

25MG/5ML

N010679 004

25MG/ML

50MG/ML

75MG/ML

100MG/ML

N005010
N005010
N005010
N005010

007

002

009

003

A080388
A080385
A080387
A080389
A080386
A088279
A088280
A088281
A088282
A089781
A089782
A089783
A089784
A089785
A089786
A089787
A089788
A086332
A080364
A080364
A080364
A073444
A073445

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

002

003

001

001

001

A040305
A081309
A040163
A073443

001

001

001

001

MEPERIDINE HYDROCHLORIDE

ABBOTT

25MG/ML

50MG/ML

50MG/ML

75MG/ML

100MG/ML

BAXTER HLTHCARE

25MG/ML

50MG/ML

75MG/ML

100MG/ML

IGI LABS INC

25MG/ML

50MG/ML

50MG/ML

50MG/ML

75MG/ML

100MG/ML

100MG/ML

100MG/ML

10MG/ML

INTL MEDICATION

50MG/ML

PARKE DAVIS

75MG/ML

100MG/ML

50MG/ML

WATSON LABS

100MG/ML

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

HOSPIRA

10MG/ML

INTL MEDICATION

10MG/ML

MALLINCKRODT

10MG/ML

WATSON LABS

10MG/ML

SYRUP;ORAL

DEMEROL

SANOFI AVENTIS US

50MG/5ML

TABLET;ORAL

MEPERIDINE HYDROCHLORIDE

DURAMED PHARMS BARR

50MG

100MG

MUTUAL PHARM

50MG

100MG

WATSON LABS

50MG

100MG

WYETH AYERST

50MG

MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

MEPERGAN

EUROHLTH INTL SARL

25MG/ML;25MG/ML

MEPHENTERMINE SULFATE

INJECTABLE;INJECTION

WYAMINE SULFATE

BAXTER HLTHCARE CORP

MEPHENYTOIN

TABLET;ORAL

MESANTOIN

NOVARTIS

Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

15,
15,
15,
15,
31,
31,
31,
31,
31,
31,
31,
31,

1984

1984

1984

1984

1989

1989

1989

1989

1989

1989

1989

1989

Mar 17, 1992

Mar 17, 1992

Mar
Aug
May
Mar

10,
30,
12,
17,

1999

1993

1997

1992

N005010 005

A040318
A040318
A080448
A080448
A040186
A040186
A080454

001

002

001

002

001

002

001

N011730 001

EQ 15MG BASE/ML

EQ 30MG BASE/ML

N008248 002

N008248 001

100MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N006008 001

Oct 05, 1999

Oct 05, 1999

Jun 30, 1997

Jun 30, 1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-221(of 347)

DISCONTINUED DRUG PRODUCT LIST

MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

ARESTOCAINE HYDROCHLORIDE

SOLVAY
CARBOCAINE

EASTMAN KODAK
MEPIVACAINE HYDROCHLORIDE

GRAHAM CHEM
INTL MEDICATION
WATSON LABS
POLOCAINE

DENTSPLY PHARM
MEPREDNISONE

TABLET;ORAL

BETAPAR

SCHERING

3%

A084777 002 Apr 18, 1982

3%

N012125 003

3%

1%

1%

2%

A083559
A087509
A088769
A088770

3%

A088653 001 Aug 21, 1984

4MG

N016053 002

MEPROBAMATE

CAPSULE;ORAL

EQUANIL

WYETH AYERST
400MG

CAPSULE, EXTENDED RELEASE;ORAL

MEPROSPAN

MEDPOINTE PHARM HLC
200MG

400MG

TABLET;ORAL

AMOSENE

FERNDALE LABS
400MG

BAMATE

ALRA
200MG

400MG

EQUANIL

WYETH AYERST
200MG

400MG

MEPRIAM

TEVA
400MG

MEPROBAMATE

BARR
600MG

ELKINS SINN
200MG

400MG

HEATHER
400MG

600MG

IMPAX LABS
200MG

400MG

IVAX SUB TEVA PHARMS
200MG

400MG

600MG

IVC INDS
400MG

LANNETT
200MG

400MG

LEDERLE
400MG

LEE KM
400MG

MALLARD
400MG

MK LABS
200MG

400MG

MUTUAL PHARM
200MG

400MG

MYLAN
400MG

NEXGEN PHARMA INC
200MG

400MG

PARKE DAVIS
200MG

400MG

PERRIGO
200MG

400MG

PHARMAVITE
400MG

PUREPAC PHARM
200MG

400MG

PVT FORM
400MG

ROXANE
600MG

SANDOZ
200MG

400MG

001

001 Oct 05, 1982

001 Nov 20, 1984

001 Nov 20, 1984

N012455 002

N011284 001

N011284 002

A084030 001

A080380 001

A080380 002

N010028 005

N010028 004

N016069 001

A084230
N015426
N015426
N016928
A084329
N014322
N014322
N015438
N015438
A084181
A084153
N014882
N014882
A086299
A089538
N015072
N014368
N014368
A080699
A080699
A083618
A084220
A084589
A084744
A084744
A084546
A084547
A084438
A084804
A084804
N014601
A084332
N014547
A080655

001

002

001

003

001

002

001

001

002

001

001

002

001

001

001 Nov 25, 1987

002

004

002

001

002

001

001

001

001

002

001

001

001

001

002

001

001

002

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-222(of 347)

DISCONTINUED DRUG PRODUCT LIST

MEPROBAMATE

TABLET;ORAL

MEPROBAMATE

SCHERER LABS
SOLVAY
STANLABS PHARM
TABLICAPS
TARO
USL PHARMA
VALEANT PHARM INTL
VANGARD
WATSON LABS

WEST WARD
WHITEWORTH TOWN PLSN
MILTOWN

MEDPOINTE PHARM HLC

NEURAMATE

HALSEY
TRANMEP

SOLVAY
MEQUINOL; TRETINOIN

SOLUTION;TOPICAL

SOLAGE

AQUA PHARMS
MERCAPTOPURINE

TABLET;ORAL

PURINETHOL

TEVA

MERSALYL SODIUM; THEOPHYLLINE

INJECTABLE;INJECTION

MERSALYL-THEOPHYLLINE

WATSON LABS

400MG
400MG
200MG
200MG
400MG
400MG
200MG
400MG
200MG
400MG
200MG
400MG
400MG
200MG
400MG
600MG
600MG
200MG
400MG
200MG
400MG

N014547
A083343
A084435
N014474
N014474
A083494
A200998
A200998
A087825
A087826
N015139
N015139
A088011
A085720
A085721
A084274
A085719
N015417
N015417
A083830
A083442

200MG
400MG
600MG

N009698 004

N009698 002

A083919 001

200MG
400MG

N014359 002

N014359 001

400MG
400MG

A084369 001

N016249 001

2%;0.01%

N020922 001 Dec 10, 1999

50MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N009053 002

100MG/ML;50MG/ML

A084875 001

MESALAMINE

SUPPOSITORY;RECTAL

CANASA

FOREST LABS LLC
500MG
ROWASA

MEDA PHARMS
500MG
TABLET, DELAYED RELEASE;ORAL

ASACOL

WARNER CHILCOTT LLC
400MG
MESORIDAZINE BESYLATE

CONCENTRATE;ORAL

SERENTIL

NOVARTIS
INJECTABLE;INJECTION

SERENTIL

NOVARTIS
TABLET;ORAL

SERENTIL

NOVARTIS

001

001

001

002

004

001

001
002
001
001
006

005

001
001

001

001

001

003

002

001

001

May
May
Mar
Mar

23,
23,
18,
18,

2011

2011

1982

1982

Jul 14, 1982

N021252 001 Jan 05, 2001

N019919 001 Dec 18, 1990

N019651 001 Jan 31, 1992

EQ 25MG BASE/ML

N016997 001

EQ 25MG BASE/ML

N016775 001

EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE

N016774 001

N016774 002

N016774 003

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6-223(of 347)

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MESORIDAZINE BESYLATE

TABLET;ORAL

SERENTIL

EQ 100MG BASE

MESTRANOL; NORETHINDRONE

TABLET;ORAL-20

NORINYL

ACTAVIS LABS UT INC

0.1MG;2MG

TABLET;ORAL-21

NORETHIN 1/50M-21

WATSON LABS

0.05MG;1MG

NORETHINDRONE AND MESTRANOL

WATSON LABS

0.05MG;1MG

NORINYL 1+50 21-DAY

ACTAVIS LABS UT INC

0.05MG;1MG

NORINYL 1+80 21-DAY

GD SEARLE LLC

0.08MG;1MG

ORTHO-NOVUM 1/50 21

ORTHO MCNEIL PHARM

0.05MG;1MG

ORTHO-NOVUM 1/80 21

ORTHO MCNEIL PHARM

0.08MG;1MG

ORTHO-NOVUM 10-21

ORTHO MCNEIL PHARM

0.06MG;10MG

ORTHO-NOVUM 2-21

ORTHO MCNEIL PHARM

0.1MG;2MG

TABLET;ORAL-28

NORETHIN 1/50M-28

WATSON LABS

0.05MG;1MG

NORETHINDRONE AND MESTRANOL

WATSON LABS

0.05MG;1MG

NORINYL 1+80 28-DAY

GD SEARLE LLC

0.08MG;1MG

ORTHO-NOVUM 1/50 28

ORTHO MCNEIL JANSSEN

0.05MG;1MG

ORTHO-NOVUM 1/80 28

ORTHO MCNEIL PHARM

0.08MG;1MG

MESTRANOL; NORETHYNODREL

TABLET;ORAL

ENOVID

GD SEARLE LLC

TABLET;ORAL-20

ENOVID

GD SEARLE LLC

ENOVID-E

GD SEARLE LLC

TABLET;ORAL-21

ENOVID-E 21

GD SEARLE LLC

METAPROTERENOL SULFATE

AEROSOL, METERED;INHALATION

ALUPENT

BOEHRINGER INGELHEIM

SOLUTION;INHALATION

ALUPENT

BOEHRINGER INGELHEIM

METAPROTERENOL SULFATE

APOTEX INC

ASTRAZENECA

DEY

MYLAN SPECLT

NEPHRON

WOCKHARDT

N016774 004

N013625 004

A071539 001 Apr 12, 1988

A070758 001 Jul 01, 1988

N013625 002

N016724 001

N012728 004

N016715 001

N012728 001

N012728 005

A071540 001 Apr 12, 1988

A070759 001 Jul 01, 1988

N016725 001

N016709 001

N016715 002

0.075MG;5MG

0.15MG;9.85MG

N010976 008

N010976 005

0.075MG;5MG

N010976 004

0.1MG;2.5MG

N010976 006

0.1MG;2.5MG

N010976 007

0.65MG/INH

N016402 001

0.4%

0.6%

5%

N018761 002 Oct 10, 1986

N018761 001 Jun 30, 1983

N017659 001

0.4%

0.6%

0.4%

0.6%

0.33%

0.5%

5%

0.4%

0.6%

0.4%

0.6%

0.4%

A075402
A075403
A071275
A071018
A071806
A071805
A070805
A071786
A070804
A071855
A071726
A075586

001
001
001
001
001
001
001
001
001
001
001
001

Feb
Feb
Jul
Jul
Aug
Aug
Aug
Aug
Aug
Jul
Jul
May

28,
28,
27,
27,
05,
05,
17,
05,
17,
14,
14,
30,

2001

2001

1988

1988

1988

1988

1987

1988

1987

1988

1988

2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-224(of 347)

DISCONTINUED DRUG PRODUCT LIST

METAPROTERENOL SULFATE

SOLUTION;INHALATION

METAPROTERENOL SULFATE

PROMETA

MURO
SYRUP;ORAL

ALUPENT

BOEHRINGER INGELHEIM
METAPROTERENOL SULFATE

APOTEX INC
G AND W LABS INC
MORTON GROVE
WOCKHARDT
PROMETA

MURO
TABLET;ORAL

ALUPENT

BOEHRINGER INGELHEIM
METAPROTERENOL SULFATE

AM THERAP
TEVA
USL PHARMA
WATSON LABS
METARAMINOL BITARTRATE

INJECTABLE;INJECTION

ARAMINE

MERCK
METARAMINOL BITARTRATE

ABRAXIS PHARM
ELKINS SINN
GD SEARLE LLC
METAXALONE

TABLET;ORAL

METAXALONE

COREPHARMA
SKELAXIN

KING PHARMS

METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLUCOPHAGE

BRISTOL MYERS SQUIBB
METFORMIN HYDROCHLORIDE

BARR

IPCA LABS LTD

IVAX SUB TEVA PHARMS

TEVA

WATSON LABS

0.6%
5%

A075586 002 May 30, 2002

A072190 001 Jun 07, 1988

5%

A073340 001 Mar 30, 1992

10MG/5ML

N017571 001

10MG/5ML
10MG/5ML
10MG/5ML
10MG/5ML
10MG/5ML

A075235
A072761
A073034
A071656
A074702

10MG/5ML

A072023 001 Sep 15, 1988

10MG
20MG

N015874 002

N015874 001

10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG

A072054
A072055
A072519
A072520
A071013
A071014
A073013
A072795

EQ 10MG BASE/ML

N009509 002 Dec 22, 1987

EQ
EQ
EQ
EQ

A080431
A083363
A086418
A086418

10MG
10MG
10MG
20MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML

001
001
001
001
001

001
001
001
001
001
001
001
001

Jan
Feb
Aug
Oct
Mar

Jun
Jun
Mar
Mar
Jan
Jan
Jan
Jan

27,
27,
30,
13,
24,

23,
23,
30,
30,
25,
25,
31,
31,

2000

1992

1991

1987

1997

1988

1988

1990

1990

1988

1988

1991

1991

001

001

001

002

640MG

N022503 001 Jun 01, 2015

400MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N013217 001

625MG
750MG

N020357 003 Nov 05, 1998

N020357 004 Nov 05, 1998

500MG
850MG
1GM
500MG
850MG
1GM
500MG
625MG
750MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG

A075971
A075971
A075971
A078422
A078422
A078422
A075975
A075975
A075975
A075975
A075975
A076328
A076328
A076328
A075979
A075979

001
002
003
001
002
003
001
004
005
002
003
001
002
003
001
002

Jan
Jan
Jan
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Jan
Dec
Dec
Dec
Jan
Jan

25,
25,
25,
06,
06,
06,
24,
24,
24,
24,
24,
16,
16,
16,
24,
24,

2002

2002

2002

2007

2007

2007

2002

2002

2002

2002

2002

2002

2002

2002

2002

2002

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6-225(of 347)

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METFORMIN HYDROCHLORIDE

TABLET;ORAL

METFORMIN HYDROCHLORIDE

1GM
TABLET, EXTENDED RELEASE;ORAL

METFORMIN HYDROCHLORIDE

ACTAVIS ELIZABETH
500MG
750MG
BARR
500MG
IVAX SUB TEVA PHARMS
500MG
MUTUAL PHARM
500MG
RANBAXY LABS LTD
500MG
750MG
SANDOZ
500MG
TORRENT PHARMS LTD
750MG
WATSON LABS INC
500MG
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDAMET

SB PHARMCO
500MG;EQ 1MG BASE **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

500MG;EQ 2MG BASE

500MG;EQ 4MG BASE
1GM;EQ 2MG BASE
1GM;EQ 4MG BASE
METHACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

RONDOMYCIN

MEDPOINTE PHARM HLC
SYRUP;ORAL

RONDOMYCIN

MEDPOINTE PHARM HLC
METHADONE HYDROCHLORIDE

SYRUP;ORAL

DOLOPHINE HYDROCHLORIDE

ROXANE
TABLET;ORAL

METHADONE HYDROCHLORIDE

ROXANE

SANDOZ
TABLET, DISPERSIBLE;ORAL

WESTADONE

SANDOZ
TABLET, EFFERVESCENT;ORAL

WESTADONE

SANDOZ

A075979 003 Jan 24, 2002

A076450
A076878
A076496
A076545
A077124
A076413
A077211
A076223
A079226
A076818

001
001
001
001
001
001
001
001
001
001

01,
13,
25,
01,
21,
18,
29,
14,
18,
14,

2004

2005

2005

2003

2005

2004

2005

2004

2010

2004

N021410 001 Oct 10, 2002

N021410
N021410
N021410
N021410

002
003
004
005

EQ 140MG BASE
EQ 280MG BASE

A060641 001

A060641 002

EQ 70MG BASE/5ML

A060641 003

10MG/30ML

N006134 004

5MG
10MG
40MG
5MG

A088108
A088109
A074081
A040241

2.5MG

N017108 001

5MG
10MG
40MG

N017108 002

N017108 003

N017108 004

METHAMPHETAMINE HYDROCHLORIDE

TABLET;ORAL

METHAMPEX

TEVA
10MG
METHAMPHETAMINE HYDROCHLORIDE

ABLE
5MG
REXAR
5MG
10MG
TEVA
5MG
TABLET, EXTENDED RELEASE;ORAL

DESOXYN

RECORDATI RARE
5MG
10MG
15MG

Oct
Apr
Nov
Dec
Dec
Jun
Jun
Dec
Feb
Dec

001
001
001
001

Oct
Oct
Aug
Aug

10,
10,
25,
25,

2002

2002

2003

2003

Mar
Mar
Apr
May

08,
08,
28,
29,

1983

1983

1995

1998

A083889 001

A040529
A084931
A084931
A086359

001 Feb 25, 2004

001

002

001

N005378 004

N005378 003

N005378 005

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6-226(of 347)

DISCONTINUED DRUG PRODUCT LIST

METHANTHELINE BROMIDE

TABLET;ORAL

BANTHINE

SHIRE

50MG

N007390 001

METHARBITAL

TABLET;ORAL

GEMONIL

ABBVIE

100MG

N008322 001

25MG

50MG

25MG

50MG

A040011
A040011
A040102
A040102

25MG

50MG

N011721 002 Nov 25, 1991

N011721 001

3.6MG

N011950 009

METHAZOLAMIDE

TABLET;ORAL

METHAZOLAMIDE

APPLIED ANAL
SANDOZ
NEPTAZANE

LEDERLE
METHDILAZINE

TABLET, CHEWABLE;ORAL

TACARYL

WESTWOOD SQUIBB

METHDILAZINE HYDROCHLORIDE

SYRUP;ORAL

METHDILAZINE HYDROCHLORIDE

ALPHARMA US PHARMS
4MG/5ML

TACARYL

WESTWOOD SQUIBB
4MG/5ML

TABLET;ORAL

TACARYL

WESTWOOD SQUIBB
8MG

METHICILLIN SODIUM

INJECTABLE;INJECTION

STAPHCILLIN

APOTHECON

METHIMAZOLE

TABLET;ORAL

METHIMAZOLE

CEDAR PHARMS
MYLAN
TAPAZOLE

KING PHARMS
METHIXENE HYDROCHLORIDE

TABLET;ORAL

TREST

NOVARTIS
METHOCARBAMOL

INJECTABLE;INJECTION

METHOCARBAMOL

MARSAM PHARMS LLC
WATSON LABS
TABLET;ORAL

DELAXIN

FERNDALE LABS
FORBAXIN

FOREST LABS
METHOCARBAMOL

ABLE
AM THERAP

EQ
EQ
EQ
EQ
EQ
EQ

900MG
900MG
3.6GM
3.6GM
5.4GM
5.4GM

001
002
001
002

Jul
Jul
Aug
Aug

17,
17,
28,
28,

1997

1997

1996

1996

A087122 001

N011950 007

N011950 006

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

BASE/VIAL

A061449
N050117
A061449
N050117
A061449
N050117

001

001

002

002

003

003

15MG

20MG

20MG

A040619 003 Jul 12, 2005

A040547 004 Feb 18, 2005

A040350 003 Jun 07, 2001

5MG

10MG

N007517 002

N007517 004

1MG

N013420 001

100MG/ML

100MG/ML

A089849 001 Dec 27, 1991

A086459 001

500MG

A085454 001

750MG

A085136 001

500MG

750MG

500MG

750MG

A040413
A040413
A089417
A089418

001
002
001
001

Mar
Mar
Feb
Feb

17,
17,
11,
11,

2003

2003

1987

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-227(of 347)

DISCONTINUED DRUG PRODUCT LIST

METHOCARBAMOL

TABLET;ORAL

METHOCARBAMOL

ASCOT

CLONMEL HLTHCARE

HEATHER

IMPAX LABS

INWOOD LABS

IVAX SUB TEVA PHARMS

KV PHARM

MUTUAL PHARM

MYLAN

NYLOS

PIONEER PHARMS

PURACAP PHARM

PUREPAC PHARM

ROXANE

SANDOZ

SOLVAY

SUPERPHARM

TABLICAPS

UPSHER SMITH

WATSON LABS

METHOHEXITAL SODIUM

INJECTABLE;INJECTION

BREVITAL SODIUM

PAR STERILE PRODUCTS

METHOTREXATE SODIUM

INJECTABLE;INJECTION

ABITREXATE

ABIC

FOLEX

PHARMACIA AND UPJOHN

FOLEX PFS

PHARMACIA AND UPJOHN

A087660
A087661
A085961
A085963
A084675
A084924
A084927
A084928
A085137
A084648
A084649
A085660
A085658
A084488
A084486
A084259
A084323
A085033
A088731
A089082
A084231
A084471
A085718
A085718
A088646
A088647
A087283
A087282
A084448
A084449
A087589
A087590
A084846
A087453
A087454
A083605
A085180
A083605
A085192

5GM/VIAL

N011559 003

EQ
EQ
EQ
EQ

25MG BASE/ML

50MG BASE/VIAL

100MG BASE/VIAL

250MG BASE/VIAL

A089161
A089354
A089355
A089356

001

001

001

001

Mar
Jul
Jul
Jul

10,
17,
17,
17,

1987

1987

1987

1987

EQ
EQ
EQ
EQ

25MG BASE/VIAL

50MG BASE/VIAL

100MG BASE/VIAL

250MG BASE/VIAL

A087695
A087695
A087695
A088954

001

002

003

001

Apr
Apr
Apr
Oct

08,
08,
08,
24,

1983

1983

1983

1985

EQ 25MG BASE/ML

EQ 25MG BASE/ML

METHOTREXATE LPF

HOSPIRA

EQ 25MG BASE/ML

METHOTREXATE PRESERVATIVE FREE

HOSPIRA
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

EQ 500MG BASE/20ML (EQ 25MG BASE/ML)

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

002

001

001

002

001

001

001

001

001

001

001

001

001

001

001

001

001

002

001

Oct 27, 1982

Oct 27, 1982

500MG

750MG

500MG

750MG

500MG

750MG

500MG

750MG

500MG

500MG

750MG

500MG

750MG

500MG

750MG

500MG

750MG

750MG

500MG

750MG

500MG

750MG

500MG

750MG

500MG

750MG

500MG

750MG

500MG

750MG

500MG

750MG

500MG

500MG

750MG

500MG

500MG

750MG

750MG

Dec 13, 1985

Dec 13, 1985

Feb 29, 1984

Feb 29, 1984

Jan 22, 1982

Jan 22, 1982

A081242 001
Aug 23, 1991

A089180 001
Jan 03, 1986

N011719 007
Mar 31, 1982

N011719 014
Apr 13, 2005

N011719 013
Apr 13, 2005

N011719 011
Apr 13, 2005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-228(of 347)

DISCONTINUED DRUG PRODUCT LIST

METHOTREXATE SODIUM

INJECTABLE;INJECTION

METHOTREXATE SODIUM

ABRAXIS PHARM

EQ 2.5MG BASE/ML
EQ 20MG BASE/VIAL
EQ 25MG BASE/ML
EQ 25MG BASE/ML
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
HOSPIRA
EQ 2.5MG BASE/ML
EQ 20MG BASE/VIAL
EQ 25MG BASE/ML
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
NORBROOK
EQ 25MG BASE/ML
PHARMACHEMIE USA
EQ 25MG BASE/ML
METHOTREXATE SODIUM PRESERVATIVE FREE

HOSPIRA
EQ 1GM BASE/VIAL
MEXATE

BRISTOL
EQ 20MG BASE/VIAL
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
MEXATE-AQ

BRISTOL MYERS
EQ 25MG BASE/ML
MEXATE-AQ PRESERVED

BRISTOL MYERS SQUIBB
EQ 25MG BASE/ML
TABLET;ORAL

METHOTREXATE SODIUM

DURAMED PHARMS BARR
EQ 2.5MG BASE

METHOXAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

VASOXYL

GLAXOSMITHKLINE
METHOXSALEN

CAPSULE;ORAL

METHOXSALEN

SANDOZ
METHSCOPOLAMINE BROMIDE

TABLET;ORAL

METHSCOPOLAMINE BROMIDE

PVT FORM
PAMINE

FOUGERA PHARMS
PAMINE FORTE

FOUGERA PHARMS
METHYCLOTHIAZIDE

TABLET;ORAL

AQUATENSEN

MEDPOINTE PHARM HLC
ENDURON

ABBVIE

METHYCLOTHIAZIDE

IVAX PHARMS
MYLAN
PAR PHARM
SANDOZ
USL PHARMA
WATSON LABS

A089323
A088935
A089263
A089322
A088936
A088937
N011719
N011719
N011719
N011719
N011719
A088648
A089158

001
001
001
001
001
001
004

001

005

003

006

001
001

Jun
Oct
Jun
Jun
Oct
Oct

13,
11,
13,
13,
11,
11,

1986

1985

1986

1986

1985

1985

May 09, 1986

Jul 08, 1988

N011719 009 Apr 07, 1988

A086358
A086358
A086358
A086358

001

002

003

004

A088760 001 Feb 14, 1985

A089887 001 Apr 14, 1989

A040233 001 Jun 17, 1999

10MG/ML
20MG/ML

N006772 002

N006772 001

10MG

A087781 001 Jun 08, 1982

2.5MG

A080970 001

2.5MG

N008848 001

5MG

N008848 002 Mar 25, 2003

5MG

N017364 001

2.5MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

5MG

N012524 001

N012524 004

2.5MG
5MG
2.5MG
2.5MG
5MG
2.5MG
5MG
5MG
2.5MG
2.5MG
5MG
5MG

A087913
A087786
A087671
A089135
A089136
A089835
A089837
A088745
A085487
A088750
A085476
A088724

001
001
001
001
001
001
001
001
001
001
001
001

Jun
May
Aug
Feb
Feb
Aug
Aug
Mar
Mar
Sep
Mar
Sep

03,
18,
17,
12,
12,
18,
18,
21,
11,
06,
11,
06,

1982

1982

1982

1986

1986

1988

1988

1985

1982

1984

1982

1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-229(of 347)

DISCONTINUED DRUG PRODUCT LIST

METHYCLOTHIAZIDE; PARGYLINE HYDROCHLORIDE

TABLET;ORAL

EUTRON

ABBOTT
5MG;25MG

N016047 001

METHYCLOTHIAZIDE; RESERPINE

TABLET;ORAL

DIUTENSEN-R

MEDPOINTE PHARM HLC

N012708 005

2.5MG;0.1MG

METHYL AMINOLEVULINATE HYDROCHLORIDE

CREAM;TOPICAL

METVIXIA
GALDERMA LABS LP
EQ 16.8% BASE
METHYLDOPA
SUSPENSION;ORAL
ALDOMET
MERCK
TABLET;ORAL
ALDOMET
MERCK

METHYLDOPA
ACCORD HLTHCARE
DURAMED PHARMS BARR
HALSEY

MUTUAL PHARM

PAR PHARM

PARKE DAVIS

PLIVA

PUREPAC PHARM

ROXANE

SANDOZ

SUPERPHARM
TEVA

WATSON LABS

METHYLDOPATE HYDROCHLORIDE
INJECTABLE;INJECTION
ALDOMET
MERCK
METHYLDOPATE HYDROCHLORIDE
ABRAXIS PHARM
BAXTER HLTHCARE
HOSPIRA

N021415 001 Jul 27, 2004

250MG/5ML

N018389 001

125MG
250MG
500MG

N013400 003
N013400 001
N013400 002

125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
250MG
500MG
125MG
250MG
500MG
125MG
125MG
250MG
250MG
250MG
500MG
500MG

A070070
A071006
A071009
A071751
A071752
A071753
A070073
A070060
A070074
A070535
A070536
A070537
A070331
A070332
A070333
A072126
A072127
A072128
A070749
A070750
A070452
A070192
A070193
A070194
A071700
N018934
N018934
A070669
A070670
A071105
A071106
A071067
A070245
A070260
A070246
A070261
A070703
A070247
A070262

50MG/ML

N013401 001

50MG/ML
50MG/ML
50MG/ML
50MG/ML

A070652
A070291
A070691
A070698

003
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
001
001

001
001
001
001

Oct
Dec
Dec
Mar
Mar
Mar
Oct
Oct
Oct
Jan
Jan
Jan
Apr
Apr
Apr
Jul
Jul
Jul
Feb
Feb
Feb
Apr
Apr
Apr
Mar
Jun
Jun
Jun
Jun
Dec
Dec
Dec
Feb
Jun
Feb
Jun
Jun
Feb
Jun

15,
16,
16,
28,
28,
28,
09,
09,
09,
02,
02,
02,
15,
15,
15,
07,
07,
07,
07,
07,
07,
25,
25,
25,
02,
29,
29,
23,
23,
05,
05,
05,
25,
24,
25,
24,
06,
25,
24,

1985
1986
1986
1988
1988
1988
1986
1986
1986
1987
1987
1987
1986
1986
1986
1988
1988
1988
1986
1986
1986
1986
1986
1986
1988
1984
1984
1989
1989
1986
1986
1986
1986
1985
1986
1985
1986
1986
1985

Jun
Jul
Jun
Jun

03,
01,
19,
15,

1986
1986
1987
1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-230(of 347)

DISCONTINUED DRUG PRODUCT LIST

METHYLDOPATE HYDROCHLORIDE

INJECTABLE;INJECTION

METHYLDOPATE HYDROCHLORIDE

MARSAM PHARMS LLC

SMITH AND NEPHEW
TEVA PARENTERAL

50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML

METHYLPHENIDATE HYDROCHLORIDE

TABLET;ORAL

METHYLPHENIDATE HYDROCHLORIDE

ABLE
5MG
10MG
20MG
ACTAVIS ELIZABETH
5MG
10MG
20MG
TABLET, CHEWABLE;ORAL

METHYLIN

MALLINCKRODT
2.5MG
5MG
10MG
TABLET, EXTENDED RELEASE;ORAL

METADATE ER

UCB INC
10MG
METHYLPHENIDATE HYDROCHLORIDE

ABLE
20MG
ACTAVIS ELIZABETH
20MG
WATSON LABS
20MG
METHYLPREDNISOLONE

TABLET;ORAL

MEDROL

PHARMACIA AND UPJOHN
METHYLPREDNISOLONE

HEATHER
PAR PHARM

SANDOZ
WATSON LABS
METHYLPREDNISOLONE ACETATE

ENEMA;RECTAL

MEDROL

PHARMACIA AND UPJOHN
INJECTABLE;INJECTION

M-PREDROL

BEL MAR

A070699
A070849
A071812
A070841
A072974

001
001
001
001
001

Jun
Jun
Dec
Jan
Nov

15,
19,
22,
02,
22,

1987

1987

1987

1987

1991

A040404
A040404
A040404
A040321
A040321
A040321

001
002
003
001
002
003

Mar
Mar
Mar
Feb
Feb
Feb

29,
29,
29,
05,
05,
05,

2001

2001

2001

2002

2002

2002

N021475 001 Apr 15, 2003

N021475 002 Apr 15, 2003

N021475 003 Apr 15, 2003

A040306 001 Oct 20, 1999

A076032 001 May 09, 2001

A075450 001 Dec 21, 2001

A040410 001 Feb 09, 2001

24MG

N011153 005

4MG
16MG
24MG
32MG
4MG
4MG
16MG

A085650
A089207
A089208
A089209
A087341
A086161
A086159

40MG/BOT

N018102 001

40MG/ML
80MG/ML

A086666 001

A087135 001

METHYLPREDNISOLONE ACETATE

AKORN
40MG/ML
80MG/ML
WATSON LABS
20MG/ML
20MG/ML
40MG/ML
40MG/ML
80MG/ML
80MG/ML
OINTMENT;TOPICAL

MEDROL ACETATE

PHARMACIA AND UPJOHN
0.25%
1%
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE

CREAM;TOPICAL

NEO-MEDROL ACETATE

PHARMACIA AND UPJOHN
0.25%;EQ 3.5MG BASE/GM
1%;EQ 3.5MG BASE/GM

A086903
A086903
A085597
A087248
A085374
A085600
A085595
A086507

001

001
001
001
001

001
001

Apr 25, 1988

Apr 25, 1988

Apr 25, 1988

Feb 09, 1982

Feb 09, 1982

001 Oct 20, 1982

002 Oct 20, 1982

001

001

001

001

001

001

N012421 001

N012421 002

A060611 002

A060611 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-231(of 347)

DISCONTINUED DRUG PRODUCT LIST

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE;INJECTION

A-METHAPRED

ABBOTT
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
HOSPIRA
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
METHYLPREDNISOLONE

ELKINS SINN
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
ORGANON USA INC
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
METHYLPREDNISOLONE SODIUM SUCCINATE

ABRAXIS PHARM
EQ 40MG BASE/VIAL
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
BEDFORD LABS
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
ELKINS SINN
EQ 40MG BASE/VIAL
INTL MEDICATION
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
TEVA PARENTERAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
WATSON LABS
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
METHYLPREDNISOLONE; NEOMYCIN SULFATE

OINTMENT;OPHTHALMIC

NEO-MEDROL

PHARMACIA AND UPJOHN
0.1%;EQ 3.5MG BASE/GM
METHYLTESTOSTERONE

CAPSULE;ORAL

METHYLTESTOSTERONE

HEATHER
VIRILON

STAR PHARMS FL
TABLET;BUCCAL

ANDROID 5

VALEANT PHARM INTL
ORETON

SCHERING
TABLET;BUCCAL, SUBLINGUAL

METANDREN

NOVARTIS

METHYLTESTOSTERONE

IMPAX LABS

A089573
A089574
A089575
A089576
A085853
A085855
A085854
A089173
A085852
A089174

001
001
001
001
001

001

001

001
001

001

Feb
Feb
Feb
Feb

22,
22,
22,
22,

1991

1991

1991

1991

A086906
A086906
A086906
A087535
A087535

002

003

004

001 Jun 25, 1982

002 Jun 25, 1982

A088676
A089143
A088677
A089144
A088678
A089186
A089187
A088679
A089188
A089189
A040662
A040641
A040641
A040709
A040641
A040709
A086906
A087812
A087813
A087851
A087852
A081266
A081267
A081268
A086953
A087030
A088523
A088524

001
001
001
001
001
001
001
001
001
001
001
002
003
001
004
002
001

001
001
001
001
001
001
001
001
001
001
001

Aug 18, 1987

Aug 18, 1987

Jun
Mar
Jun
Mar
Jun
Mar
Mar
Jun
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb

08,
28,
08,
28,
08,
28,
28,
08,
28,
28,
21,
21,
21,
21,
21,
21,

1984

1986

1984

1986

1984

1986

1986

1984

1986

1986

2007

2007

2007

2007

2007

2007

Feb
Feb
Feb
Feb
Nov
Nov
Nov
Jul
Jul
Jul
Jul

09,
09,
09,
09,
30,
30,
30,
22,
22,
24,
24,

1983

1983

1983

1983

1992

1992

1992

1982

1982

1984

1984

A060645 001

10MG

A084967 001

10MG

A087750 001 Nov 24, 1982

5MG

A087222 001

10MG

A080281 001

5MG
10MG
10MG
25MG

N003240
N003240
N003240
N003240

10MG

A084287 001

004

001

005

003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-232(of 347)

DISCONTINUED DRUG PRODUCT LIST

METHYLTESTOSTERONE

TABLET;BUCCAL, SUBLINGUAL

METHYLTESTOSTERONE

LILLY

PUREPAC PHARM

PVT FORM

TABLICAPS

USL PHARMA

TABLET;ORAL

METHYLTESTOSTERONE

INWOOD LABS

KV PHARM

LANNETT

PARKE DAVIS

PUREPAC PHARM

PVT FORM

TABLICAPS

WATSON LABS

WEST WARD

ORETON METHYL

SCHERING

METHYPRYLON

CAPSULE;ORAL

NOLUDAR

ROCHE

ELIXIR;ORAL

NOLUDAR

ROCHE

TABLET;ORAL

NOLUDAR

ROCHE

METHYSERGIDE MALEATE

TABLET;ORAL

SANSERT

NOVARTIS

10MG

25MG

10MG

10MG

10MG

25MG

5MG

10MG

10MG

A080256
A080256
A080308
A080475
A080475
A080475
A083836
A085125
A080271

001

002

001

001

002

003

001

001

001

10MG

25MG

10MG

10MG

25MG

10MG

25MG

10MG

25MG

5MG

10MG

25MG

10MG

25MG

10MG

25MG

10MG

25MG

25MG

A080839
A080973
A084312
A087092
A087111
A084244
A084241
A080309
A080310
A080214
A080214
A080214
A080313
A085270
A080933
A080931
A084331
A084331
A084642

001

001

001

001 Nov 05, 1982

001 Jan 27, 1983

001

001

001

001

001

002

003

001

001

001

001

001

002

001

10MG

25MG

N003158 001

N003158 002

300MG

N009660 008

50MG/5ML

N009660 007

50MG

200MG

N009660 002

N009660 004

2MG

N012516 001

METOCLOPRAMIDE HYDROCHLORIDE

CONCENTRATE;ORAL

METOCLOPRAMIDE INTENSOL

ROXANE

EQ
INJECTABLE;INJECTION

METOCLOPRAMIDE HYDROCHLORIDE

BEDFORD

EQ
EQ
EQ
HOSPIRA

EQ
EQ
EQ
EQ
EQ
EQ
EQ
LYPHOMED

EQ
NORBROOK

EQ
SMITH AND NEPHEW

EQ
EQ

10MG BASE/ML

A072995 001 Jan 30, 1992

5MG BASE/ML

5MG BASE/ML

5MG BASE/ML

5MG BASE/ML

5MG BASE/ML

5MG BASE/ML

5MG BASE/ML

5MG BASE/ML

5MG BASE/ML

5MG BASE/ML

10MG BASE/2ML

10MG BASE/2ML

5MG BASE/ML

10MG BASE/2ML

A072155
A072244
A072247
A070505
A070506
A070847
A071291
A071990
A073117
A074147
A070293
A070892
A070623
A070622

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Mar
Mar
May
Jun
Jun
Nov
Mar
Jan
Jan
Aug
Jan
Aug
Mar
Mar

30,
30,
18,
23,
22,
07,
03,
18,
17,
02,
24,
26,
02,
02,

1992

1992

1992

1989

1989

1988

1989

1989

1991

1996

1986

1988

1987

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-233(of 347)

DISCONTINUED DRUG PRODUCT LIST

METOCLOPRAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

REGLAN

EUROHLTH INTL SARL

EQ 5MG BASE/ML
EQ 10MG BASE/ML

SOLUTION;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

ACTAVIS MID ATLANTIC
EQ 5MG BASE/5ML
MORTON GROVE
EQ 5MG BASE/5ML
PACO
EQ 5MG BASE/5ML
ROXANE
EQ 5MG BASE/5ML
TEVA
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
REGLAN

ROBINS AH
EQ 5MG BASE/5ML **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

TABLET;ORAL

CLOPRA

QUANTUM PHARMICS
EQ 5MG BASE
EQ 10MG BASE
CLOPRA-"YELLOW"

QUANTUM PHARMICS
EQ 10MG BASE
MAXOLON

KING PHARMS
EQ 10MG BASE
METOCLOPRAMIDE HYDROCHLORIDE

CLONMEL
EQ 10MG BASE
HALSEY
EQ 10MG BASE
INTERPHARM
EQ 10MG BASE
MUTUAL PHARM
EQ 10MG BASE
EQ 10MG BASE
PAR PHARM
EQ 10MG BASE
SANDOZ
EQ 5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
SCHERING
EQ 10MG BASE
SUPERPHARM
EQ 10MG BASE
USL PHARMA
EQ 10MG BASE
WATSON LABS
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
TABLET, ORALLY DISINTEGRATING;ORAL

METOZOLV ODT

SALIX PHARMS
EQ 10MG BASE **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

REGLAN ODT

MEDA PHARMS
EQ 5MG BASE
EQ 10MG BASE
METOCURINE IODIDE

INJECTABLE;INJECTION

METUBINE IODIDE

LILLY
METOLAZONE

TABLET;ORAL

DIULO

GD SEARLE LLC

METOLAZONE

ROXANE
TEVA

WATSON LABS
MYKROX

UCB INC

N017862 001

N017862 004 May 28, 1987

A071340
A070949
A071665
A072038
A070819
A071315

001
001
001
001
001
001

Aug
Mar
Dec
Dec
Jul
Jun

18,
06,
05,
05,
10,
30,

1988

1987

1988

1988

1987

1993

N018821 001 Mar 25, 1983

A072384 001 Jun 02, 1988

A070294 001 Jul 29, 1985

A070632 001 Oct 28, 1985

A070106 001 Mar 04, 1986

A072639
A070906
A071213
A070660
A071536
A070342
A072436
A074478
A070850
A072215
A074478
A070598
A070926
A070339
A070363
A070453
A070511
A070645

001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001

May
Oct
Sep
Feb
Apr
Mar
Jun
Oct
Feb
Jan
Oct
Feb
Jun
Jul
Mar
Jun
Jan
May

09,
28,
24,
10,
28,
25,
22,
05,
03,
30,
05,
02,
26,
29,
02,
06,
22,
11,

1991

1986

1986

1987

1993

1986

1989

1995

1987

1990

1995

1987

1987

1985

1987

1986

1986

1987

N022246 002 Sep 04, 2009

N021793 001 Jun 10, 2005

N021793 002 Jun 10, 2005

2MG/ML

N006632 003

2.5MG
5MG
10MG

N018535 001

N018535 002

N018535 003

10MG
2.5MG
5MG
10MG
10MG

A076482
A076600
A076833
A075543
A076891

0.5MG

N019532 001 Oct 30, 1987

002
001
001
003
001

Apr
Jan
Mar
Dec
Jul

29,
06,
01,
24,
21,

2004

2004

2004

2003

2004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-234(of 347)

DISCONTINUED DRUG PRODUCT LIST

METOPROLOL FUMARATE

TABLET, EXTENDED RELEASE;ORAL

LOPRESSOR

NOVARTIS
EQ
EQ
EQ
EQ

100MG
200MG
300MG
400MG

TARTRATE
TARTRATE
TARTRATE
TARTRATE

N019786
N019786
N019786
N019786

001
002
003
004

Dec
Dec
Dec
Dec

27,
27,
27,
27,

1989

1989

1989

1989

METOPROLOL SUCCINATE

TABLET, EXTENDED RELEASE;ORAL

METOPROLOL SUCCINATE

NESHER PHARMS
EQ
EQ
EQ
EQ
SANDOZ
EQ
EQ
EQ
EQ

25MG TARTRATE
50MG TARTRATE
100MG TARTRATE
200MG TARTRATE
25MG TARTRATE
50MG TARTRATE
100MG TARTRATE
200MG TARTRATE

A077779
A077176
A076640
A076640
A076969
A076969
A076969
A076969

001
001
002
001
001
002
003
004

Mar
May
May
May
Jul
May
Mar
Mar

20,
14,
18,
18,
31,
18,
20,
20,

2008

2008

2007

2007

2006

2007

2008

2008

METOPROLOL TARTRATE

INJECTABLE;INJECTION

METOPROLOL TARTRATE

WATSON LABS
TABLET;ORAL

METOPROLOL TARTRATE

APOTHECON
MYLAN
PRINSTON INC
PUREPAC PHARM
TEVA
TEVA PHARMS
METRIZAMIDE

INJECTABLE;INJECTION

AMIPAQUE

GE HEALTHCARE

1MG/ML

A074032 001 Dec 21, 1993

50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG

A074258
A074258
A073666
A073666
A074453
A074453
A074380
A074380
A074143
A074143
A074333
A074333

001
002
001
002
001
002
001
002
001
002
001
002

2.5GM/VIAL
3.75GM/VIAL
6.75GM/VIAL
13.5GM/VIAL

N017982
N017982
N017982
N017982

003 Sep 12, 1983

001

002

004 Sep 12, 1983

METRONIDAZOLE

CAPSULE;ORAL

METRONIDAZOLE

ABLE
375MG
INJECTABLE;INJECTION

FLAGYL I.V. RTU IN PLASTIC CONTAINER

PFIZER
500MG/100ML
METRO I.V.

B BRAUN
500MG/100ML
METRONIDAZOLE

ABBOTT
500MG/100ML
ABRAXIS PHARM
500MG/100ML
EUROHLTH INTL SARL
500MG/100ML
INTL MEDICATION
500MG/100ML
WATSON LABS
500MG/100ML
500MG/100ML
TABLET;ORAL

METROMIDOL

LABS AF
250MG
500MG
METRONIDAZOLE

ABLE
250MG
500MG
HALSEY
250MG
500MG
IVAX SUB TEVA PHARMS 250MG
500MG

Jan
Jan
Dec
Dec
Apr
Apr
Jul
Jul
Sep
Sep
Jan
Jan

27,
27,
21,
21,
27,
27,
29,
29,
30,
30,
27,
27,

1994

1994

1993

1993

1995

1995

1994

1994

1994

1994

1994

1994

A076505 001 Nov 13, 2003

N018353 002

N018674 001 Aug 31, 1982

N018889
A070071
N018907
A070004
A070042
A070170

001
001
001
001
001
001

Nov
Dec
Mar
May
Dec
Apr

18,
03,
30,
08,
20,
01,

1983

1984

1984

1985

1984

1986

A074523 001 Oct 24, 1996

A074523 002 Oct 24, 1996

A076519
A076519
A070021
A070593
N018517
N018517

001
002
001
001
001

002

Jun
Jun
Apr
Feb

27,
27,
02,
27,

2003

2003

1985

1986

May 05, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-235(of 347)

DISCONTINUED DRUG PRODUCT LIST

METRONIDAZOLE

TABLET;ORAL

METRONIDAZOLE

LNK
MUTUAL PHARM

250MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG

N019029
N018818
N018818
N018845
N018930
N018620
N018740
N018620
N018740
A070008
A070009
A070040
A070039
N018599
N018764
N018599
N018764

250MG
500MG

N018871 001 Mar 02, 1983

N018871 002 Mar 02, 1983

250MG
500MG
TABLET, EXTENDED RELEASE;ORAL

METRONIDAZOLE

ABLE
750MG

A070029 001 Mar 19, 1985

A070731 001 Jun 08, 1987

PAR PHARM
SANDOZ

SUPERPHARM
VIVIMED LABS
WATSON LABS

PROTOSTAT

ORTHO MCNEIL PHARM
SATRIC

SAVAGE LABS

MEXILETINE HYDROCHLORIDE

CAPSULE;ORAL

MEXILETINE HYDROCHLORIDE

IDT AUSTRALIA LTD

WATSON LABS

MEXITIL

BOEHRINGER INGELHEIM

Apr
Feb
Feb
Aug
Aug
Mar
Oct
Jun
Oct
Dec
Dec
Jan
Jan
Sep
Sep
Feb
Dec

10,
16,
16,
18,
18,
04,
22,
02,
22,
11,
11,
29,
29,
17,
17,
13,
20,

1984

1983

1983

1983

1983

1982

1982

1983

1982

1984

1984

1985

1985

1982

1982

1984

1982

A076462 001 Jun 25, 2003

METRONIDAZOLE HYDROCHLORIDE

INJECTABLE;INJECTION

FLAGYL I.V.

PFIZER
EQ 500MG BASE/VIAL
METRONIDAZOLE HYDROCHLORIDE

ABRAXIS PHARM
EQ 500MG BASE/VIAL
METYRAPONE

TABLET;ORAL

METOPIRONE

HRA PHARMA

001
001
002
001
001
001
001
002
002
001
001
001
001
001
001
002
002

N018353 001

A070295 001 Oct 15, 1985

250MG

N012911 001

150MG
200MG
250MG
150MG
150MG
200MG
200MG
250MG
250MG

A074450
A074450
A074450
A074711
A074865
A074711
A074865
A074711
A074865

150MG
200MG
250MG

N018873 002 Dec 30, 1985

N018873 003 Dec 30, 1985

N018873 004 Dec 30, 1985

MEZLOCILLIN SODIUM MONOHYDRATE

INJECTABLE;INJECTION

MEZLIN

BAYER PHARMS
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1GM
1GM
1GM
2GM
2GM
2GM
3GM
3GM
3GM
3GM
4GM
4GM

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

A062333
A062372
N050549
A062333
A062372
N050549
A062333
A062372
A062697
N050549
A062333
A062372

001
002
003
001
001
002
002
003
003

001

005
001

002

001
002

003

002
001
003

004

003

May
May
May
Feb
Apr
Feb
Apr
Feb
Apr

16,
16,
16,
26,
13,
26,
13,
26,
13,

1996

1996

1996

1997

1998

1997

1998

1997

1998

Jan 13, 1983

May 13, 1982

May 13, 1982

Jan 22, 1987

May 13, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-236(of 347)

DISCONTINUED DRUG PRODUCT LIST

MEZLOCILLIN SODIUM MONOHYDRATE

INJECTABLE;INJECTION

MEZLIN

EQ
EQ
EQ
EQ
MICONAZOLE

INJECTABLE;INJECTION

MONISTAT

JANSSEN PHARMA

4GM BASE/VIAL
4GM BASE/VIAL
20GM BASE/VIAL
20GM BASE/VIAL

10MG/ML

MICONAZOLE NITRATE

CREAM;TOPICAL

MONISTAT-DERM

INSIGHT PHARMS
2%
CREAM;VAGINAL

MICONAZOLE NITRATE

TEVA
2%
TEVA PHARMS
2%
CREAM, SUPPOSITORY;TOPICAL, VAGINAL

M-ZOLE 7 DUAL PACK

ACTAVIS MID ATLANTIC
2%,100MG
LOTION;TOPICAL

MONISTAT-DERM

INSIGHT PHARMS
2%
TAMPON;VAGINAL

MONISTAT 5

PERSONAL PRODS
100MG
MIDAZOLAM HYDROCHLORIDE

INJECTABLE;INJECTION

MIDAZOLAM HYDROCHLORIDE

APOTHECON

BEDFORD
BEN VENUE
CLARIS PHARMASERVICE
HOSPIRA

HOSPIRA INC
IGI LABS INC
INTL MEDICATED
INTL MEDICATION
WOCKHARDT

VERSED

HLR
SYRUP;ORAL

MIDAZOLAM HYDROCHLORIDE

APOTEX INC
VERSED

ROCHE
MIDODRINE HYDROCHLORIDE

TABLET;ORAL

PROAMATINE

SHIRE LLC

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1MG
5MG
5MG
5MG
5MG
1MG
5MG
1MG
5MG
5MG
1MG
5MG
5MG
1MG
5MG
1MG
5MG
1MG
1MG
5MG
5MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

A062697
N050549
A062372
N050549

002 Jan 22, 1987

004

004 Mar 02, 1988

005 Mar 02, 1988

N018040 001

N017494 001

A074136 001 Jan 04, 1995

A074030 001 Oct 30, 1992

A074586 001 Jul 17, 1997

N017739 001

N018592 001 Oct 27, 1989

A075620
A075620
A075641
A075249
A075455
A075637
A075637
A075396
A075396
A075484
A075409
A075409
A075263
A076144
A076144
A076020
A076020
A078141
A078511
A078141
A078511

001
002
001
001
001
001
002
001
002
001
002
001
001
001
002
001
002
001
001
002
002

Nov
Nov
Oct
Jun
Jun
Oct
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Jan
Jan
Jul
Jul
May
Nov
May
Nov

01,
01,
19,
23,
20,
31,
31,
20,
20,
20,
20,
20,
26,
26,
26,
16,
16,
30,
10,
30,
10,

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2000

2005

2005

2004

2004

2008

2008

2008

2008

EQ 1MG BASE/ML
EQ 5MG BASE/ML

N018654 002 May 26, 1987

N018654 001 Dec 20, 1985

EQ 2MG BASE/ML

A077115 001 Sep 09, 2005

EQ 2MG BASE/ML

N020942 001 Oct 15, 1998

2.5MG
5MG
10MG

N019815 001 Sep 06, 1996

N019815 002 Sep 06, 1996

N019815 003 Mar 20, 2002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-237(of 347)

DISCONTINUED DRUG PRODUCT LIST

MILRINONE LACTATE

INJECTABLE;INJECTION

MILRINONE LACTATE

APOTEX INC
EUROHLTH INTL SARL
HOSPIRA

EQ 1MG BASE/ML
EQ 1MG BASE/ML
EQ 1MG BASE/ML
EQ 1MG BASE/ML
MYLAN INSTITUTIONAL
EQ 1MG BASE/ML
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

APOTEX INC
EQ 20MG BASE/100ML (EQ 0.2MG
BAXTER HLTHCARE
EQ 20MG BASE/100ML (EQ 0.2MG
HIKMA MAPLE
EQ 20MG BASE/100ML (EQ 0.2MG
PRIMACOR

SANOFI AVENTIS US
EQ 1MG BASE/ML
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER

SANOFI AVENTIS US
EQ 10MG BASE/100ML
EQ 15MG BASE/100ML
EQ 20MG BASE/100ML (EQ 0.2MG
EQ 40MG BASE/200ML (EQ 0.2MG

MINOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL

DYNACIN

CNTY LINE PHARMS
MINOCIN

PRECISION DERMAT
TRIAX PHARMS

EQ 50MG BASE

EQ 75MG BASE
EQ 50MG BASE
EQ 100MG BASE
CAPSULE, EXTENDED RELEASE;ORAL

XIMINO

SUN PHARM INDS LTD
EQ 45MG BASE
EQ 67.5MG BASE
EQ 90MG BASE
EQ 112.5MG BASE
EQ 135MG BASE
INJECTABLE;INJECTION

MINOCIN

LEDERLE
EQ 100MG BASE/VIAL
SUSPENSION;ORAL

MINOCIN

PRECISION DERMAT
EQ 50MG BASE/5ML
TABLET;ORAL

MINOCYCLINE HYDROCHLORIDE

TRIAX PHARMS
EQ 50MG BASE
EQ 100MG BASE
TABLET, EXTENDED RELEASE;ORAL

MINOCYCLINE HYDROCHLORIDE

LUPIN LTD
EQ 55MG BASE
SOLODYN

MEDICIS
EQ 45MG BASE
EQ 90MG BASE
EQ 135MG BASE

MINOXIDIL

SOLUTION;TOPICAL

MINOXIDIL (FOR MEN)

APOTEX INC
2%
BAUSCH AND LOMB
2%
COPLEY PHARM
2%
SIGHT PHARMS
2%
TEVA
2%
MINOXIDIL (FOR WOMEN)

APOTEX INC
2%
SIGHT PHARMS
2%
MINOXIDIL EXTRA STRENGTH (FOR MEN)

APOTEX INC
5%
TABLET;ORAL

LONITEN

PHARMACIA AND UPJOHN
2.5MG
10MG
MINODYL

QUANTUM PHARMICS
2.5MG
10MG

A076427
A075852
A075830
A075884
A076428
BASE/ML)
BASE/ML)
BASE/ML)

001
001
001
001
001

Sep
May
May
May
Jun

21,
28,
28,
28,
16,

2004

2002

2002

2002

2003

A077151 001 Jul 20, 2005

A076259 001 Aug 08, 2002

A075510 001 May 28, 2002

N019436 001 Dec 31, 1987

BASE/ML)
BASE/ML)

N020343
N020343
N020343
N020343

001
002
003
004

Aug
Aug
Aug
Aug

09,
09,
09,
09,

1994

1994

1994

1994

A063066 001 Aug 14, 1990

N050649 003 Feb 12, 2001

N050315 002

N050315 001

N201922
N201922
N201922
N201922
N201922

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

11,
11,
11,
11,
11,

2012

2012

2012

2012

2012

A062139 001

N050445 001

N050451 003 Aug 10, 1982

N050451 002 Aug 10, 1982

A091424 002 Nov 30, 2011

N050808 001 May 08, 2006

N050808 002 May 08, 2006

N050808 003 May 08, 2006

A074924
A074643
A074500
A074743
A074589

001
001
001
002
001

Apr
Apr
May
Oct
Apr

29,
09,
23,
18,
05,

1998

1996

1996

1996

1996

A074924 002 Apr 29, 1998

A074743 001 Oct 18, 1996

A075839 001 Oct 01, 2001

N018154 001

N018154 003

A072153 001 Jul 13, 1988

A071534 001 Mar 19, 1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-238(of 347)

DISCONTINUED DRUG PRODUCT LIST

MINOXIDIL

TABLET;ORAL

MINOXIDIL

ROYCE LABS
USL PHARMA

2.5MG
10MG
2.5MG

MIRTAZAPINE

TABLET;ORAL

MIRTAZAPINE

ACTAVIS ELIZABETH

15MG
15MG
30MG
30MG
45MG
45MG
IVAX SUB TEVA PHARMS 15MG
30MG
45MG
ROXANE
15MG
30MG
45MG
SANDOZ
15MG
30MG
45MG
TABLET, ORALLY DISINTEGRATING;ORAL

MIRTAZAPINE

ACTAVIS ELIZABETH
15MG
15MG
30MG
30MG
45MG
45MG

MITOMYCIN

INJECTABLE;INJECTION

MITOMYCIN

HOSPIRA
MITOZYTREX

SUPERGEN
MUTAMYCIN

BRISTOL
BRISTOL MYERS

A071799 001 Nov 10, 1987

A071796 001 Nov 10, 1987

A071537 001 Dec 16, 1988

A076241
A076308
A076241
A076308
A076241
A076308
A076244
A076244
A076244
A076270
A076270
A076270
A076189
A076189
A076189

001
001
002
002
003
003
001
002
003
001
002
003
001
002
003

Jun
Jun
Jun
Jun
Jun
Jun
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun

25,
20,
25,
20,
25,
20,
22,
22,
22,
19,
19,
19,
19,
19,
19,

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

A076689
A077959
A076689
A077959
A076689
A077959

001
001
002
002
003
003

Aug
Feb
Aug
Feb
Aug
Feb

31,
14,
31,
14,
31,
14,

2005

2011

2005

2011

2005

2011

20MG/VIAL

A064106 001 Nov 29, 1995

5MG/VIAL

N050763 001 Nov 14, 2002

5MG/VIAL
20MG/VIAL
5MG/VIAL
20MG/VIAL
40MG/VIAL

N050450
N050450
A062336
A062336
A062336

MITOXANTRONE HYDROCHLORIDE

INJECTABLE;INJECTION

MITOXANTRONE HYDROCHLORIDE

FRESENIUS KABI ONCOL EQ
EQ
EQ
NOVANTRONE

EMD SERONO
EQ
EQ
EQ

001

002

001

002

003 Mar 10, 1988

20MG BASE/10ML (EQ 2MG BASE/ML)

25MG BASE/12.5ML (EQ 2MG BASE/ML)
30MG BASE/15ML (EQ 2MG BASE/ML)

A078606 001 May 14, 2008

A078606 002 May 14, 2008

A078606 003 May 14, 2008

20MG BASE/10ML (EQ 2MG BASE/ML)

25MG BASE/12.5ML (EQ 2MG BASE/ML)
30MG BASE/15ML (EQ 2MG BASE/ML)

N019297 001 Dec 23, 1987

N019297 002 Dec 23, 1987

N019297 003 Dec 23, 1987

MIVACURIUM CHLORIDE

INJECTABLE;INJECTION

MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBVIE
EQ 0.5MG BASE/ML
EQ 50MG BASE/100ML
MIVACURIUM CHLORIDE

MYLAN LABS LTD
EQ 2MG BASE/ML
SOLUTION;INTRAVENOUS

MIVACRON

ABBVIE
EQ 2MG BASE/ML (EQ 2MG BASE/ML)

N020098 002 Jan 22, 1992

N020098 003 Jan 22, 1992

A078562 001 Apr 30, 2009

N020098 001 Jan 22, 1992

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-239(of 347)

DISCONTINUED DRUG PRODUCT LIST

MOLINDONE HYDROCHLORIDE

CAPSULE;ORAL

MOBAN

ENDO PHARMS

5MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

10MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

25MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N017111 001

20MG/ML

N017938 001

5MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

10MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

25MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

50MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

100MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N017111 004

MOMETASONE FUROATE

OINTMENT;TOPICAL

MOMETASONE FUROATE

TARO

0.1%

A076624 001 Dec 03, 2004

MONOBENZONE

CREAM;TOPICAL

BENOQUIN

VALEANT PHARM INTL

20%

N008173 003

MONOCTANOIN

LIQUID;PERFUSION, BILIARY

MOCTANIN

ETHITEK

100%

N019368 001 Oct 29, 1985

200MG
250MG
300MG

N019753 001 Jun 19, 1990

N019753 002 Jun 19, 1990

N019753 003 Jun 19, 1990

CONCENTRATE;ORAL

MOBAN

ENDO PHARMS
TABLET;ORAL

MOBAN

ENDO PHARMS

MORICIZINE HYDROCHLORIDE

TABLET;ORAL

ETHMOZINE

SHIRE

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

AVINZA

KING PHARMS LLC
30MG
45MG
60MG
75MG
90MG
120MG
INJECTABLE;INJECTION

MORPHINE SULFATE

HOSPIRA
0.5MG/ML
MALLINCKRODT
1MG/ML
2MG/ML
WATSON LABS
0.5MG/ML

N017111 002

N017111 003

N017111 005

N017111 006

N017111 007

N017111 008

N021260
N021260
N021260
N021260
N021260
N021260

001
005
002
006
003
004

Mar
Dec
Mar
Dec
Mar
Mar

20,
18,
20,
18,
20,
20,

2002

2008

2002

2008

2002

2002

N019917
N020631
N020631
A073373

001
001
002
001

Oct
Jul
Jul
Sep

30,
03,
03,
30,

1992

1996

1996

1991

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-240(of 347)

DISCONTINUED DRUG PRODUCT LIST

MORPHINE SULFATE

INJECTABLE;INJECTION

MORPHINE SULFATE

0.5MG/ML
1MG/ML
1MG/ML
INJECTABLE, LIPOSOMAL;EPIDURAL

DEPODUR

PACIRA PHARMS INC
10MG/ML (10MG/ML)
15MG/1.5ML (10MG/ML)
20MG/2ML (10MG/ML)
TABLET, EXTENDED RELEASE;ORAL

MORPHINE SULFATE

WATSON LABS
100MG
ORAMORPH SR

XANODYNE PHARMS INC
15MG
30MG
60MG
100MG
MOXALACTAM DISODIUM

INJECTABLE;INJECTION

MOXAM

LILLY

MYCOPHENOLATE MOFETIL

CAPSULE;ORAL

MYCOPHENOLATE MOFETIL

DR REDDYS LABS LTD
ZYDUS PHARMS USA INC
TABLET;ORAL

MYCOPHENOLATE MOFETIL

DR REDDYS LABS LTD
ZYDUS PHARMS USA INC
NABUMETONE

TABLET;ORAL

NABUMETONE

COPLEY PHARM
DR REDDYS LABS LTD
PROSAM LABS
SANDOZ
RELAFEN

SMITHKLINE BEECHAM
NADOLOL
TABLET;ORAL
CORGARD
US WORLD MEDS LLC
NADOLOL
IVAX SUB TEVA PHARMS
TEVA PHARMS

NAFCILLIN SODIUM
CAPSULE;ORAL
UNIPEN
WYETH AYERST
FOR SOLUTION;ORAL
UNIPEN
WYETH AYERST

EQ
EQ
EQ
EQ
EQ

250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

A073375 001 Sep 30, 1991

A073374 001 Sep 30, 1991

A073376 001 Sep 30, 1991

N021671 001 May 18, 2004

N021671 002 May 18, 2004

N021671 003 May 18, 2004

A075656 001 Jan 30, 2001

N019977
N019977
N019977
N019977

004
001
002
003

N050550
N050550
N050550
N050550
N050550

001

002

003

004

008

Nov
Aug
Aug
Aug

23,
15,
15,
15,

1994

1991

1991

1991

250MG
250MG

A091315 001 Oct 27, 2011

A065433 001 May 04, 2009

500MG
500MG

A090464 001 Sep 13, 2010

A065477 001 May 04, 2009

750MG
500MG
750MG
500MG
750MG
500MG
750MG

A075179
A078420
A078420
A079093
A079093
A075590
A075590

500MG
750MG

N019583 001 Dec 24, 1991

N019583 002 Dec 24, 1991

120MG
160MG

N018063 003
N018063 004

120MG
160MG
80MG
120MG
160MG

A074255
A074255
A074368
A074368
A074368

EQ 250MG BASE

N050111 001

EQ 250MG BASE/5ML

N050199 001

001
001
002
001
002
001
002

002
003
001
002
003

Jun
Sep
Sep
Feb
Feb
Feb
Feb

Jan
Jan
Aug
Aug
Aug

06,
24,
24,
27,
27,
25,
25,

24,
24,
31,
31,
31,

2000

2008

2008

2009

2009

2002

2002

1996
1996
1994
1994
1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-241(of 347)

DISCONTINUED DRUG PRODUCT LIST

NAFCILLIN SODIUM

INJECTABLE;INJECTION

NAFCILLIN SODIUM

APOTHECON

SANDOZ
WATSON LABS INC

NALLPEN

GLAXOSMITHKLINE

UNIPEN

WYETH AYERST

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

500MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

1.5GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

10GM BASE/VIAL

A061984
A061984
A061984
A061984
A062527
A062844
A062844
A062844
A062844
A062844
A063008

001

002

003

005

001
001
002
003
004
005
001

EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL

1GM BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

2GM BASE/VIAL

10GM BASE/VIAL

A061999
A061999
A062755
A061999
A062755
A061999

001

002

001 Dec 19, 1986

003

002 Dec 19, 1986

004

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

10GM BASE/VIAL

20GM BASE/VIAL

A062717
N050320
A062717
A062717
N050320
N050320
N050320
N050320

001 Dec 16, 1986

001

002 Dec 16, 1986

004 Dec 16, 1986

003

004

005

006

UNIPEN IN PLASTIC CONTAINER

WYETH AYERST
EQ 1GM BASE/VIAL

TABLET;ORAL

UNIPEN

WYETH AYERST
EQ 500MG BASE

NALBUPHINE HYDROCHLORIDE

INJECTABLE;INJECTION

NALBUPHINE

ABRAXIS PHARM
NALBUPHINE HYDROCHLORIDE

ABBOTT
ABBVIE
BARR
IGI LABS INC

NUBAIN

ENDO PHARMS
NALIDIXIC ACID

SUSPENSION;ORAL

NEGGRAM

SANOFI AVENTIS US
TABLET;ORAL

NALIDIXIC ACID

MUTUAL PHARM

WATSON LABS

NEGGRAM

SANOFI AVENTIS US

Aug
Oct
Oct
Oct
Oct
Oct
Sep

02,
26,
26,
26,
26,
26,
29,

1984

1988

1988

1988

1988

1988

1988

N050320 002

N050462 001

10MG/ML

20MG/ML

A070751 001 Jul 02, 1986

A070752 001 Sep 24, 1986

20MG/ML

1.5MG/ML

10MG/ML

20MG/ML

10MG/ML

10MG/ML

10MG/ML

20MG/ML

20MG/ML

20MG/ML

A070917
N020200
A074471
A074471
A072070
A072071
A072072
A072073
A072074
A072075

10MG/ML

20MG/ML

N018024 001

N018024 002 May 27, 1982

250MG/5ML

N017430 001

250MG

500MG

1GM

250MG

500MG

1GM

A070270
A070271
A070272
A071936
A072061
A071919

250MG

500MG

1GM

N014214 002

N014214 004

N014214 005

001
001
001
002
001
001
001
001
001
001

001
001
001
001
001
001

Feb
Mar
Mar
Mar
Apr
Apr
Apr
Apr
Apr
Apr

Jun
Jun
Jun
Jun
Jun
Jun

03,
12,
19,
19,
10,
10,
10,
10,
10,
10,

29,
29,
29,
29,
29,
29,

1989

1993

1998

1998

1989

1989

1989

1989

1989

1989

1988

1988

1988

1988

1988

1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-242(of 347)

DISCONTINUED DRUG PRODUCT LIST

NALMEFENE HYDROCHLORIDE

INJECTABLE;INJECTION

REVEX

EUROHLTH INTL SARL
NALOXONE HYDROCHLORIDE

INJECTABLE;INJECTION

NALOXONE

HIKMA MAPLE
WYETH AYERST

NALOXONE HYDROCHLORIDE

ABRAXIS PHARM

ASTRAZENECA
HIKMA MAPLE

HOSPIRA

IGI LABS INC

INTL MEDICATION
MARSAM PHARMS LLC
SMITH AND NEPHEW

SOLOPAK
WATSON LABS
NARCAN

ADAPT

BRISTOL MYERS SQUIBB

EQ 0.1MG BASE/ML
EQ 1MG BASE/ML

N020459 001 Apr 17, 1995

N020459 002 Apr 17, 1995

0.4MG/ML
0.4MG/ML
0.02MG/ML
0.02MG/ML
0.4MG/ML
0.4MG/ML

A070298
A070496
A070188
A070189
A070190
A070191

001
001
001
001
001
001

Sep
Sep
Sep
Sep
Sep
Sep

24,
24,
24,
24,
24,
24,

1986

1986

1986

1986

1986

1986

0.02MG/ML
0.02MG/ML
0.4MG/ML
1MG/ML
0.02MG/ML
0.02MG/ML
1MG/ML
1MG/ML
1MG/ML
0.02MG/ML
0.02MG/ML
0.02MG/ML
0.4MG/ML
0.02MG/ML
0.02MG/ML
0.02MG/ML
0.02MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
1MG/ML
1MG/ML
1MG/ML
0.4MG/ML
1MG/ML
0.4MG/ML
0.02MG/ML
0.4MG/ML
0.4MG/ML
0.02MG/ML
0.4MG/ML
0.4MG/ML

A070648
A070661
A070649
A071604
A072081
A071272
A071273
A071274
A071287
A070171
A070252
A070253
A070255
A072082
A072083
A072084
A072085
A072086
A072087
A072088
A072089
A072090
A072091
A072092
A072093
A070417
A072115
A071811
A071671
A071681
A071682
A071672
A071683
A071339

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Nov
Nov
Nov
Dec
Apr
May
May
May
May
Sep
Jan
Jan
Jan
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Sep
Apr
Jul
Nov
Nov
Nov
Nov
Nov
Nov

17,
17,
17,
16,
11,
24,
24,
24,
24,
24,
16,
16,
07,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
24,
27,
19,
17,
17,
17,
17,
17,
18,

1986

1986

1986

1988

1989

1988

1988

1988

1988

1986

1987

1987

1987

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

1986

1988

1988

1987

1987

1987

1987

1987

1987

0.02MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

0.4MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

1MG/ML **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

0.4MG/ML
1MG/ML
1MG/ML

N016636 002

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

TARGINIQ

PURDUE PHARMA LP
5MG;10MG
10MG;20MG
20MG;40MG

N016636 001

N016636 003 Jun 14, 1982

A071083 001 Jul 28, 1988

A071084 001 Jul 28, 1988

A071311 001 Jul 28, 1988

N205777 001 Jul 23, 2014

N205777 002 Jul 23, 2014

N205777 003 Jul 23, 2014

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-243(of 347)

DISCONTINUED DRUG PRODUCT LIST

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

TALWIN NX
SANOFI AVENTIS US
EQ 0.5MG BASE;EQ 50MG BASE

N018733 001 Dec 16, 1982

NALTREXONE HYDROCHLORIDE
TABLET;ORAL
NALTREXONE HYDROCHLORIDE
SANDOZ

50MG

A075434 001 Mar 08, 2000

50MG/ML
100MG/ML
200MG/ML

N013132 001 Jun 12, 1986

N013132 002 Jun 12, 1986
N013132 003 Jun 12, 1986

100MG/ML
200MG/ML
100MG/ML
50MG/ML
50MG/ML
50MG/ML
100MG/ML
100MG/ML
200MG/ML

A088290
A088317
A087519
A086385
A087598
A088554
A086598
A087599
A088128

25MG/ML
50MG/ML

N011891 001
N011891 002

25MG/ML
50MG/ML

A086386 001 Jun 17, 1983

A087488 001 Jun 17, 1983

0.1% **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

A080248 001

0.1%
0.1%

A040073 001 May 25, 1994

A088101 001 Apr 15, 1983

0.1%

A080229 001

0.1%

A087506 001

0.1%

A080235 002 Mar 24, 1983

250MG
250MG
375MG
375MG
500MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG

A074105
A074410
A074105
A074410
A074105
A074410
A074110
A074110
A074110
A074111
A074111
A074111
A074182
A074182
A074182
A074263
A074263
A074263
A074211

NANDROLONE DECANOATE
INJECTABLE;INJECTION
DECA-DURABOLIN
ASPEN GLOBAL INC

NANDROLONE DECANOATE
ABRAXIS PHARM
AKORN
WATSON LABS

NANDROLONE PHENPROPIONATE
INJECTABLE;INJECTION
DURABOLIN
ORGANON USA INC
NANDROLONE PHENPROPIONATE
WATSON LABS
NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
ALBALON
ALLERGAN

NAFAZAIR
BAUSCH AND LOMB
PHARMAFAIR
NAPHCON FORTE
ALCON
OPCON
BAUSCH AND LOMB
VASOCON
NOVARTIS
NAPROXEN
TABLET;ORAL
NAPROXEN
DAVA PHARMS INC

HAMILTON PHARMS

IVAX SUB TEVA PHARMS

PLIVA

PUREPAC PHARM

ROXANE

001
001
001
001
001
001
001
001
001

001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003
001

Oct
Oct
Sep
Jan
Oct
Feb
Jan
Oct
Dec

Dec
Apr
Dec
Apr
Dec
Apr
Oct
Oct
Oct
Feb
Feb
Feb
Jun
Jun
Jun
Dec
Dec
Dec
Feb

03,
14,
28,
13,
06,
10,
13,
06,
05,

21,
28,
21,
28,
21,
28,
30,
30,
30,
28,
28,
28,
27,
27,
27,
21,
21,
21,
28,

1983
1983
1983
1984
1983
1986
1984
1983
1983

1993
1995
1993
1995
1993
1995
1992
1992
1992
1995
1995
1995
1996
1996
1996
1993
1993
1993
1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-244(of 347)

DISCONTINUED DRUG PRODUCT LIST

NAPROXEN

TABLET;ORAL

NAPROXEN

TEVA

TEVA PHARMS

WATSON LABS

375MG
500MG
250MG
250MG
375MG
375MG
500MG
500MG
250MG
375MG
500MG
250MG
250MG
375MG
375MG
500MG
500MG

A074211
A074211
A074129
A074216
A074129
A074216
A074129
A074216
A074207
A074207
A074207
A074163
A074457
A074163
A074457
A074163
A074457

TABLET, DELAYED RELEASE;ORAL

NAPROXEN

ACTAVIS ELIZABETH
375MG
500MG
NAPROXEN SODIUM

TABLET;ORAL

NAPROXEN SODIUM

ABLE
HAMILTON PHARMS
IVAX SUB TEVA PHARMS
MYLAN
PLIVA
PUREPAC PHARM
ROXANE
SANDOZ

TEVA
TEVA PHARMS
WATSON LABS

NATEGLINIDE

TABLET;ORAL

NATEGLINIDE

TEVA PHARMS
NEBIVOLOL HYDROCHLORIDE

TABLET;ORAL

NEBIVOLOL HYDROCHLORIDE

ALKEM LABS LTD

AMERIGEN PHARMS LTD

INDCHEMIE HEALTH

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
200MG
250MG
250MG
500MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG

002
003
001
001
002
002
003
003
001
002
003
001
001
002
002
003
003

Feb
Feb
Dec
Apr
Dec
Apr
Dec
Apr
Dec
Dec
Dec
Feb
May
Feb
May
Feb
May

28,
28,
21,
11,
21,
11,
21,
11,
21,
21,
21,
10,
31,
10,
31,
10,
31,

1994

1994

1993

1996

1993

1996

1993

1996

1993

1993

1993

1995

1995

1995

1995

1995

1995

A074936 001 Feb 24, 1998

A074936 002 Feb 24, 1998

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A076544
A076544
A074106
A074106
A074230
A074230
A074367
A074367
A074242
A074242
A074319
A074319
A074257
A074257
A074646
A074162
A074495
A074162
A074495
A074142
A074142
A074289
A074289
A074195
A074455
A074195
A074455

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
001
002
002
001
002
001
002
001
001
002
002

Aug
Aug
Aug
Aug
Mar
Mar
Aug
Aug
Jun
Jun
Mar
Mar
Dec
Dec
Jan
Dec
Dec
Dec
Dec
Dec
Dec
Jan
Jan
Dec
May
Dec
May

22,
22,
31,
31,
14,
14,
31,
31,
20,
20,
20,
20,
21,
21,
13,
21,
05,
21,
05,
21,
21,
27,
27,
21,
31,
21,
31,

2003

2003

1993

1993

1995

1995

1994

1994

1996

1996

1995

1995

1993

1993

1997

1993

1994

1993

1994

1993

1993

1994

1994

1993

1995

1993

1995

60MG
120MG

A077467 001 Sep 09, 2009

A077467 002 Sep 09, 2009

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A203741
A203741
A203741
A203741
A203659
A203659
A203659
A203659
A203828

2.5MG BASE
5MG BASE
10MG BASE
20MG BASE
2.5MG BASE
5MG BASE
10MG BASE
20MG BASE
2.5MG BASE

001
002
003
004
001
002
003
004
001

Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Jul

24,
24,
24,
24,
16,
16,
16,
16,
29,

2015

2015

2015

2015

2015

2015

2015

2015

2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-245(of 347)

DISCONTINUED DRUG PRODUCT LIST

NEBIVOLOL HYDROCHLORIDE

TABLET;ORAL

NEBIVOLOL HYDROCHLORIDE

WATSON LABS INC

NEDOCROMIL SODIUM

AEROSOL, METERED;INHALATION

TILADE

KING PHARMS
SOLUTION;INHALATION

TILADE

SANOFI AVENTIS US
NEFAZODONE HYDROCHLORIDE

TABLET;ORAL

NEFAZODONE HYDROCHLORIDE

IDT AUSTRALIA LTD

IVAX SUB TEVA PHARMS

MYLAN

ROXANE

SANDOZ

WATSON LABS

SERZONE

BRISTOL MYERS SQUIBB

NELFINAVIR MESYLATE

POWDER;ORAL

VIRACEPT

AGOURON
NEOMYCIN SULFATE

POWDER;FOR RX COMPOUNDING

NEO-RX

X GEN PHARMS
SOLUTION;ORAL

MYCIFRADIN

PHARMACIA AND UPJOHN
TABLET;ORAL

MYCIFRADIN

PHARMACIA AND UPJOHN

EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
20MG BASE
2.5MG BASE
5MG BASE
10MG BASE
20MG BASE

A203828
A203828
A203828
A203683
A203683
A203683
A203683

002
003
004
001
002
003
004

Jul
Jul
Jul
Nov
Nov
Nov
Nov

29,
29,
29,
27,
27,
27,
27,

2015

2015

2015

2015

2015

2015

2015

1.75MG/INH

N019660 001 Dec 30, 1992

0.5%

N020750 001 Oct 01, 1997

50MG
100MG
150MG
200MG
250MG
50MG
100MG
150MG
200MG
250MG
100MG
150MG
200MG
250MG
50MG
100MG
150MG
200MG
250MG
50MG
100MG
150MG
200MG
250MG
100MG
150MG
200MG
250MG

A076072
A076072
A076072
A076072
A076072
A075763
A075763
A075763
A075763
A075763
A076129
A076129
A076129
A076129
A076196
A076196
A076196
A076196
A076196
A076302
A076302
A076302
A076302
A076302
A076073
A076073
A076073
A076073

001
002
003
004
005
001
002
003
004
005
002
003
004
005
001
002
003
004
005
001
002
003
004
005
002
003
004
005

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

2003

50MG
100MG
150MG
200MG
250MG
300MG

N020152
N020152
N020152
N020152
N020152
N020152

001
002
003
004
005
006

Dec
Dec
Dec
Dec
Dec
Dec

22,
22,
22,
22,
22,
22,

1994

1994

1994

1994

1994

1994

EQ 50MG BASE/SCOOPFUL

N020778 001 Mar 14, 1997

100%

A061579 001

EQ 87.5MG BASE/5ML

N050285 001

EQ 350MG BASE

A060520 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-246(of 347)

DISCONTINUED DRUG PRODUCT LIST

NEOMYCIN SULFATE

TABLET;ORAL

NEOBIOTIC

PFIZER

NEOMYCIN SULFATE

BRISTOL MYERS SQUIBB

LANNETT

LILLY

ROXANE

SANDOZ

EQ 350MG BASE

A060475 001

500MG

500MG

500MG

500MG

500MG

A060365
A060607
A060385
A062173
A061586

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CREAM;TOPICAL

NEOSPORIN

GLAXOSMITHKLINE

EQ 3.5MG
OINTMENT;OPHTHALMIC

STATROL

ALCON

EQ 3.5MG
SOLUTION/DROPS;OPHTHALMIC

STATROL

ALCON

EQ 3.5MG
EQ 3.5MG

BASE/GM;10,000 UNITS/GM

N050176 002 Jan 14, 1985

BASE/GM;10,000 UNITS/GM

N050344 002

BASE/ML;16,250 UNITS/ML

BASE/ML;16,250 UNITS/ML

A062339 001 Nov 30, 1984

N050456 001

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC

POLY-PRED

ALLERGAN
EQ 0.35% BASE;10,000 UNITS/ML;0.5%

NEOMYCIN SULFATE; PREDNISOLONE ACETATE

OINTMENT;OPHTHALMIC

NEO-DELTA-CORTEF
PHARMACIA AND UPJOHN
EQ 3.5MG BASE/GM;0.25%
EQ 3.5MG BASE/GM;0.5%
SUSPENSION/DROPS;OPHTHALMIC
NEO-DELTA-CORTEF
PHARMACIA AND UPJOHN
EQ 3.5MG BASE/ML;0.25%
NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

OINTMENT;OPHTHALMIC

NEO-HYDELTRASOL

MERCK
EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE

NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

MYTREX A

SAVAGE LABS
EQ 3.5MG BASE/GM;0.1%

NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE

FOUGERA
EQ 3.5MG BASE/GM;0.1%

PHARMADERM
EQ 3.5MG BASE/GM;0.1%

OINTMENT;TOPICAL

MYTREX A

SAVAGE LABS
EQ 3.5MG BASE/GM;0.1%

NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE

FOUGERA

EQ 3.5MG BASE/GM;0.1%

PHARMADERM

EQ 3.5MG BASE/GM;0.1%

NETILMICIN SULFATE

INJECTABLE;INJECTION

NETROMYCIN

SCHERING

NIACIN

CAPSULE;ORAL

WAMPOCAP

MEDPOINTE PHARM HLC

TABLET;ORAL

NIACIN

EVERYLIFE

HALSEY

HIKMA PHARMS LLC

IMPAX LABS

IVAX SUB TEVA PHARMS

MK LABS

PUREPAC PHARM

001

001

001

001

001

N050081 002

A061039 002

A061039 001

A061037 001

N050378 001

A062598 001 Jul 21, 1986

A062600 001 Jul 21, 1986

A062595 001 Jul 21, 1986

A062609 001 May 23, 1986

A062608 001 May 23, 1986

A062607 001 May 23, 1986

EQ 10MG BASE/ML

EQ 25MG BASE/ML

EQ 100MG BASE/ML

N050544 001 Feb 28, 1983

N050544 002 Feb 28, 1983

N050544 003 Feb 28, 1983

500MG

N011073 003

500MG

500MG

500MG

500MG

500MG

500MG

500MG

A083203
A083453
A083718
A083115
A083180
A083525
A083271

001

001

001

001

001

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-247(of 347)

DISCONTINUED DRUG PRODUCT LIST

NIACIN

TABLET;ORAL

NIACIN

SANDOZ
TABLICAPS
WATSON LABS

500MG
500MG
500MG
500MG
500MG

A083306
A084237
A083136
A083305
A085172

NICOLAR

SANOFI AVENTIS US
500MG
TABLET, EXTENDED RELEASE;ORAL

NIASPAN

ABBVIE
375MG
NIASPAN TITRATION STARTER PACK

ABBVIE
375MG

A083823 001

N020381 001 Jul 28, 1997

N020381 005 Jul 28, 1997

NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; TYROSINE

SUSPENSION;ORAL

TPN

INTL MINERALS
15MG/5ML;3.75MG/5ML;600MG/5ML
NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL

NICARDIPINE HYDROCHLORIDE

WATSON LABS

20MG
30MG
CAPSULE, EXTENDED RELEASE;ORAL

CARDENE SR
CHIESI USA INC
30MG
45MG
60MG

NICLOSAMIDE
TABLET, CHEWABLE;ORAL
NICLOCIDE
BAYER PHARMS

N020005 001 Feb 21, 1992

N020005 002 Feb 21, 1992
N020005 003 Feb 21, 1992

500MG

IVAX SUB TEVA PHARMS

NIFEDIPINE
CAPSULE;ORAL
ADALAT
BAYER PHARMS
NIFEDIPINE
CATALENT
CHASE LABS NJ

EQ
EQ
EQ
EQ

2MG
4MG
2MG
4MG

N008378 003

A074670 001 Oct 28, 1996

A074670 002 Oct 28, 1996

N018669 001 May 14, 1982

NICOTINE
FILM, EXTENDED RELEASE;TRANSDERMAL
NICOTROL
MCNEIL CONS
15MG/16HR
PROSTEP
AVEVA
11MG/24HR
22MG/24HR
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICOTINE POLACRILEX
ACTAVIS LABS NY INC

001

001

001

001

001

BASE
BASE
BASE
BASE

N020536 001 Jul 03, 1996

N019983 003 Dec 23, 1998
N019983 004 Dec 23, 1998

A076568
A076569
A076880
A077850

001
002
001
001

Jul
Jul
Feb
Feb

29,
29,
18,
18,

2004
2004
2009
2009

10MG
20MG

N019478 001 Nov 27, 1985

N019478 002 Sep 17, 1986

10MG
20MG
10MG
20MG
10MG

A073250
A074045
A072409
A073421
A072651

TEVA
PROCARDIA
PFIZER
20MG
TABLET, EXTENDED RELEASE;ORAL
NIFEDIPINE
MARTEC USA LLC
90MG
MYLAN
30MG

001
001
001
001
001

Oct
Apr
Jul
Jun
Feb

08,
30,
04,
19,
19,

1991
1992
1990
1991
1992

N018482 002 Jul 24, 1986

A075414 003 Mar 23, 2004

A075108 001 Dec 17, 1999

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6-248(of 347)

DISCONTINUED DRUG PRODUCT LIST

NILUTAMIDE

TABLET;ORAL

NILANDRON

CONCORDIA PHARMS INC
NIMODIPINE

CAPSULE;ORAL

NIMOTOP

BAYER PHARMS

50MG

N020169 001 Sep 19, 1996

30MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N018869 001 Dec 28, 1988

NISOLDIPINE

TABLET, EXTENDED RELEASE;ORAL

SULAR

SHIONOGI INC
10MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

20MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

25.5MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

30MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

40MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

NITRIC OXIDE

GAS;INHALATION

INOMAX

INO
NITROFURANTOIN

CAPSULE;ORAL

NITROFURANTOIN

WATSON LABS
TABLET;ORAL

FURADANTIN

PROCTER AND GAMBLE
FURALAN

LANNETT
NITROFURANTOIN

ELKINS SINN
IVAX SUB TEVA PHARMS
SANDOZ
WATSON LABS

WHITEWORTH TOWN PLSN

NITROFURANTOIN SODIUM

INJECTABLE;INJECTION

IVADANTIN

PROCTER AND GAMBLE

N020356 001 Feb 02, 1995

N020356 002 Feb 02, 1995

N020356 006 Jan 02, 2008

N020356 003 Feb 02, 1995

N020356 004 Feb 02, 1995

100PPM

N020845 002 Dec 23, 1999

50MG
100MG

A084326 001

A084326 002

50MG
100MG

N008693 001

N008693 002

50MG
100MG

A080017 001

A080017 002

50MG
100MG
50MG
100MG
50MG
100MG
50MG
50MG
100MG
100MG
100MG

A080003
A080003
A080078
A080078
A080043
A080043
A080447
A085797
A080447
A085796
A084085

EQ 180MG BASE/VIAL

N012402 001

001

002

002

001

001

002

001

001

002

001

002

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6-249(of 347)

DISCONTINUED DRUG PRODUCT LIST

NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

NITROFURANTOIN
MYLAN
100MG
SANDOZ
25MG
50MG
100MG
WATSON LABS
25MG
50MG
100MG
NITROFURANTOIN MACROCRYSTALLINE
WATSON LABS
50MG
100MG

A070248 001 Jun 24, 1988

A070249 001 Jun 24, 1988

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
RANBAXY LABS LTD
75MG;25MG

A076951 001 Mar 30, 2005

NITROFURAZONE
CREAM;TOPICAL
FURACIN
SHIRE
DRESSING;TOPICAL
ACTIN-N
SHERWOOD MEDCL
OINTMENT;TOPICAL
FURACIN
SHIRE
NITROFURAZONE
AMBIX
LANNETT
PERRIGO NEW YORK
TARO
WENDT
POWDER;TOPICAL
FURACIN
SHIRE
SOLUTION;TOPICAL
NITROFURAZONE
PERRIGO NEW YORK
WENDT

A074967
A074336
A074336
A074336
A073696
A073696
A073696

002
001
002
003
001
002
003

0.2%

A083789 001

0.2%

N017343 001

0.2%

N005795 001

0.2%
0.2%
0.2%
0.2%
0.2%

A086077
A084393
A084968
A086156
A086766

0.2%

A083791 001

0.2%
0.2%

A085130 001
A087081 001

NITROGLYCERIN
AEROSOL;SUBLINGUAL
NITROLINGUAL
POHL BOSKAMP
0.4MG/SPRAY
FILM, EXTENDED RELEASE;TRANSDERMAL
NITROGLYCERIN
KREMERS URBAN PHARMS
0.2MG/HR
0.4MG/HR
MYLAN TECHNOLOGIES
0.1MG/HR
0.2MG/HR
0.4MG/HR
0.6MG/HR
TRANSDERM-NITRO
NOVARTIS
0.1MG/HR
0.2MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
INJECTABLE;INJECTION
NITRO IV
POHL BOSKAMP
5MG/ML
NITRO-BID
SANOFI AVENTIS US
5MG/ML
10MG/ML
NITROGLYCERIN
ABRAXIS PHARM
5MG/ML
5MG/ML
HOSPIRA
5MG/ML
INTL MEDICATION
5MG/ML
LUITPOLD
5MG/ML
SMITH AND NEPHEW
5MG/ML

Jul
Jan
Jan
Jan
Dec
Dec
Dec

09,
25,
25,
25,
31,
31,
31,

1997
1995
1995
1995
1992
1992
1992

001
001
001
001
001

N018705 001 Oct 31, 1985

A075115
A075115
A074992
A074992
A074992
A074992

001
002
004
003
002
001

Aug
Aug
Nov
Nov
Nov
Nov

10,
10,
12,
12,
12,
12,

2004
2004
1999
1999
1999
1999

N020144
N020144
N020144
N020144
N020144

001
002
003
004
005

Feb
Feb
Feb
Feb
Feb

27,
27,
27,
27,
27,

1996
1996
1996
1996
1996

N018672 002 Aug 30, 1983

N018621 001 Jan 05, 1982
A071159 001 Feb 28, 1990
A070077
A071203
N018531
A070026
A071492
A070633

001
001
001
001
001
001

Dec 13, 1985

May 08, 1987
Sep 10, 1985
May 24, 1988
Jun 19, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-250(of 347)

DISCONTINUED DRUG PRODUCT LIST

NITROGLYCERIN

INJECTABLE;INJECTION

NITROGLYCERIN

5MG/ML

NITROGLYCERIN IN DEXTROSE 5%

HOSPIRA

0.1MG/ML

NITROL

RORER

0.8MG/ML

NITRONAL

POHL BOSKAMP

1MG/ML

NITROSTAT

PARKE DAVIS

0.8MG/ML

5MG/ML

5MG/ML

10MG/ML

10MG/ML

TRIDIL

HOSPIRA

0.5MG/ML

5MG/ML

NIZATIDINE

CAPSULE;ORAL

AXID

SMITHKLINE BEECHAM

A070634 001 Jun 19, 1986

A074083 001 Oct 26, 1994

N018774 001 Jan 19, 1983

N018672 001 Aug 30, 1983

N018588
A070863
N018588
A070871
A070872

001

001
002
001
001

Jan
Dec
Jan
Jan

08,
23,
08,
08,

1987

1983

1987

1987

N018537 002 Jun 16, 1983

N018537 001

150MG

300MG

N019508 001 Apr 12, 1988

N019508 002 Apr 12, 1988

150MG

300MG

150MG

300MG

150MG

300MG

A075461
A075461
A076383
A076383
A075934
A075934

NONOXYNOL-9

AEROSOL;VAGINAL

DELFEN

PERSONAL PRODS

12.5%

N014349 002

NOREPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

NOREPINEPHRINE BITARTRATE

METRICS PHARM

EQ 1MG BASE/ML

A040522 001 Sep 30, 2004

NIZATIDINE

ANI PHARMS INC

APOTEX INC

MYLAN PHARMS INC

001
002
001
002
001
002

Jul
Jul
Jan
Jan
Jul
Jul

08,
08,
23,
23,
09,
09,

2002

2002

2003

2003

2002

2002

NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

RAVOCAINE AND NOVOCAIN W/ LEVOPHED

EASTMAN KODAK

EQ 0.033MG BASE/ML;2%;0.4%
N008592 003

NORETHINDRONE

TABLET;ORAL

NORLUTIN

PARKE DAVIS

5MG

N010895 002

NORETHINDRONE ACETATE

TABLET;ORAL

NORLUTATE

PARKE DAVIS

5MG

N012184 002

0.3%

N019757 001 Jun 17, 1991

400MG

N019384 002 Oct 31, 1986

0.075MG

N017031 001

NORFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

CHIBROXIN

MERCK

TABLET;ORAL

NOROXIN

MERCK

NORGESTREL

TABLET;ORAL

OVRETTE

LABORATOIRE HRA

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6-251(of 347)

DISCONTINUED DRUG PRODUCT LIST

NORTRIPTYLINE HYDROCHLORIDE

CAPSULE;ORAL

AVENTYL HYDROCHLORIDE

LILLY

EQ 10MG BASE

EQ 25MG BASE

NORTRIPTYLINE HYDROCHLORIDE

SANDOZ

EQ 10MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 50MG BASE

EQ 75MG BASE

EQ 75MG BASE

TEVA

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 75MG BASE

SOLUTION;ORAL

AVENTYL

RANBAXY

EQ 10MG BASE/5ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

PAMELOR

MALLINCKRODT INC

EQ 10MG BASE/5ML

NYSTATIN

CREAM;TOPICAL

CANDEX

BAYER PHARMS

MYCOSTATIN

DELCOR ASSET CORP

MYKINAC

ALPHARMA US PHARMS

NILSTAT

LEDERLE

NYSTATIN

TARO

LOTION;TOPICAL

CANDEX

BAYER PHARMS

OINTMENT;TOPICAL

MYCOSTATIN

DELCOR ASSET CORP

MYKINAC

ALPHARMA US PHARMS

NILSTAT

LEDERLE

PASTILLE;ORAL

MYCOSTATIN

BRISTOL MYERS SQUIBB

POWDER;ORAL

BARSTATIN 100

BARLAN

NILSTAT

DAVA PHARMS INC

NYSTATIN

PADDOCK LLC

POWDER;TOPICAL

MYCOSTATIN

DELCOR ASSET CORP

NYSTATIN

NESHER PHARMS

N014684 001

N014684 002

A074054
A074835
A074054
A074835
A074054
A074835
A074054
A074835
A073667
A073667
A073667
A073667

001

001

002

002

003

003

004

004

001

002

003

004

Dec
Jun
Dec
Jun
Dec
Jun
Dec
Jun
Apr
Apr
Apr
Apr

31,
30,
31,
30,
31,
30,
31,
30,
11,
11,
11,
11,

1992

1997

1992

1997

1992

1997

1992

1997

1996

1996

1996

1996

N014685 001

N018012 001

100,000 UNITS/GM

A061810 001

100,000 UNITS/GM **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

A060575 001

100,000 UNITS/GM

A062387 001
Jul 29, 1982

100,000 UNITS/GM

A061445 001

100,000 UNITS/GM

A062457 001
Jul 28, 1983

100,000 UNITS/ML

N050233 001

100,000 UNITS/GM **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

A060571 001

100,000 UNITS/GM

A062731 001
Sep 22, 1986

100,000 UNITS/GM

A061444 001

200,000 UNITS

N050619 001
Apr 09, 1987

100%

A062489 001
Apr 27, 1988

100%

N050576 001
Dec 22, 1983

100%

A062613 001
Nov 26, 1985

100,000 UNITS/GM **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

A060578 001

100,000 UNITS/GM

A065321 001
Aug 18, 2006

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6-252(of 347)

DISCONTINUED DRUG PRODUCT LIST

NYSTATIN

SUPPOSITORY;VAGINAL

NYSERT

WARNER CHILCOTT

SUSPENSION;ORAL

MYCOSTATIN

DELCOR ASSET CORP

NILSTAT

GLENMARK GENERICS

NYSTATIN

ALPHARMA US PHARMS

G AND W LABS INC

MORTON GROVE

PHARMADERM

PHARMAFAIR

ROXANE

TEVA

NYSTEX

SAVAGE LABS

TABLET;ORAL

MYCOSTATIN

DELCOR ASSET CORP

NILSTAT

LEDERLE

NYSTATIN

QUANTUM PHARMICS

SANDOZ

USL PHARMA

WATSON LABS

TABLET;VAGINAL

KOROSTATIN

HOLLAND RANTOS

MYCOSTATIN

DELCOR ASSET CORP

NILSTAT

LEDERLE

NYSTATIN

FOUGERA

PHARMADERM

QUANTUM PHARMICS

SANDOZ

TEVA

WATSON LABS

100,000 UNITS

N050478 001

100,000 UNITS/ML

A061533 001

100,000 UNITS/ML

N050299 001

100,000
100,000
100,000
100,000
100,000
100,000
100,000

A062571
A062776
A062835
A062518
A062541
A062832
A062670

UNITS/ML

UNITS/ML

UNITS/ML

UNITS/ML

UNITS/ML

UNITS/ML

UNITS/ML

001
001
001
001
001
001
001

Oct
Dec
Nov
Jul
Jan
Dec
Jun

29,
17,
19,
06,
16,
27,
18,

1985

1987

1987

1984

1985

1991

1987

100,000 UNITS/ML

A062519 001 Jul 06, 1984

500,000 UNITS

A060574 001

500,000 UNITS

A061151 001

500,000
500,000
500,000
500,000

A062525
A062065
A062524
A062402

UNITS

UNITS

UNITS

UNITS

001 Oct 29, 1984

001

001 Nov 26, 1985

001 Dec 16, 1982

100,000 UNITS

A061718 001

100,000 UNITS

A060577 001

100,000 UNITS

A061325 001

100,000
100,000
100,000
100,000
100,000
100,000

A062459
A062460
A062509
A061965
A062502
A062176

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

MYCO-TRIACET II

TEVA
100,000 UNITS/GM;0.1%

MYCOLOG-II

DELCOR ASSET CORP
100,000 UNITS/GM;0.1%

100,000 UNITS/GM;0.1%

MYTREX F

SAVAGE LABS
100,000 UNITS/GM;0.1%

NYSTATIN AND TRIAMCINOLONE ACETONIDE

ALPHARMA US PHARMS
100,000 UNITS/GM;0.1%

PERRIGO NEW YORK

100,000 UNITS/GM;0.1%

PHARMAFAIR
100,000 UNITS/GM;0.1%

TARO
100,000 UNITS/GM;0.1%

NYSTATIN-TRIAMCINOLONE ACETONIDE

PHARMADERM

100,000 UNITS/GM;0.1%

OINTMENT;TOPICAL

MYCO-TRIACET II

TEVA

100,000 UNITS/GM;0.1%

MYCOLOG-II

DELCOR ASSET CORP

100,000 UNITS/GM;0.1%

MYTREX F

SAVAGE LABS

100,000 UNITS/GM;0.1%

NYSTATIN AND TRIAMCINOLONE ACETONIDE

PERRIGO NEW YORK
100,000 UNITS/GM;0.1%

PHARMAFAIR
100,000 UNITS/GM;0.1%

NYSTATIN-TRIAMCINOLONE ACETONIDE

PHARMADERM
100,000 UNITS/GM;0.1%

001
001
001
001

001
001

Nov 09, 1983

Nov 09, 1983

Apr 03, 1984

Dec 23, 1983

A061954 002 Sep 20, 1985

A060576 002 May 01, 1985

A062606 001 May 15, 1985

A062597 001 Oct 08, 1985

A063010
A062186
A062657
A062347

001
002
001
001

Dec
Jun
Jul
Mar

20,
06,
30,
30,

1988

1985

1986

1987

A062596 001 Oct 08, 1985

A062045 002 Nov 26, 1985

A060572 001 Jun 28, 1985

A062601 001 Oct 09, 1985

A062280 002 Oct 10, 1985

A062656 001 Jul 30, 1986

A062603 001 Oct 09, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-253(of 347)

DISCONTINUED DRUG PRODUCT LIST

OFLOXACIN

INJECTABLE;INJECTION

FLOXIN

ORTHO MCNEIL PHARM

20MG/ML
40MG/ML

FLOXIN IN DEXTROSE 5%

ORTHO MCNEIL PHARM
400MG/100ML
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER

ORTHO MCNEIL PHARM
4MG/ML
400MG/100ML
OFLOXACIN

BEDFORD
40MG/ML
SOLUTION/DROPS;OPHTHALMIC

OFLOXACIN

APOTEX INC
0.3%
SANDOZ
0.3%
TABLET;ORAL

FLOXIN

JANSSEN PHARMS
200MG
300MG
400MG
OFLOXACIN

LARKEN LABS
200MG
300MG
RANBAXY LABS LTD
200MG
300MG
400MG

N020087 002 Mar 31, 1992

N020087 003 Mar 31, 1992

N020087 001 Mar 31, 1992

N020087 004 Mar 31, 1992

N020087 005 Mar 31, 1992

A075762 001 Jan 16, 2002

A076513 001 May 14, 2004

A076848 001 Nov 25, 2008

N019735 001 Dec 28, 1990

N019735 002 Dec 28, 1990

N019735 003 Dec 28, 1990

A076093
A076093
A076220
A076220
A076220

001
002
001
002
003

Sep
Sep
Sep
Sep
Sep

02,
02,
02,
02,
02,

2003

2003

2003

2003

2003

OMEPRAZOLE; SODIUM BICARBONATE

FOR SUSPENSION;ORAL

OMEPRAZOLE AND SODIUM BICARBONATE

PAR PHARM
20MG/PACKET;1.68GM/PACKET
40MG/PACKET;1.68GM/PACKET

A079182 001 Apr 19, 2013

A079182 002 Apr 19, 2013

ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL

ONDANSETRON

NESHER PHARMS
4MG
8MG
PAR PHARM
4MG
8MG
16MG
24MG

A077717
A077717
A076506
A076506
A077406
A077406

001
002
001
002
001
002

Jun
Jun
Dec
Dec
Dec
Dec

25,
25,
26,
26,
26,
26,

2007

2007

2006

2006

2006

2006

A077368
A076695
A090116
A077582
A077544
A078180

001
001
001
001
001
001

Dec
Dec
Apr
Dec
Dec
Mar

26,
26,
14,
26,
26,
26,

2006

2006

2010

2006

2006

2007

ONDANSETRON HYDROCHLORIDE

INJECTABLE;INJECTION

ONDANSETRON HYDROCHLORIDE

APOTEX INC
EQ 2MG BASE/ML
HOSPIRA
EQ 2MG BASE/ML
LANNETT
EQ 2MG BASE/ML
LUITPOLD
EQ 2MG BASE/ML
PLIVA HRVATSKA DOO
EQ 2MG BASE/ML
SAGENT PHARMS
EQ 2MG BASE/ML
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

HOSPIRA
EQ 0.64MG BASE/ML
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

APOTEX INC
EQ 2MG BASE/ML
HOSPIRA
EQ 2MG BASE/ML
LUITPOLD
EQ 2MG BASE/ML
TARO PHARMS IRELAND
EQ 2MG BASE/ML
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

GLAXOSMITHKLINE
EQ 0.64MG BASE/ML
TABLET;ORAL

ONDANSETRON HYDROCHLORIDE

HIKMA PHARMS LLC
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
PAR PHARM
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
TARO
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE

A076978 001 Feb 26, 2007

A077343
A076696
A077387
A078014

001
001
001
001

Dec
Dec
Dec
Mar

26,
26,
26,
21,

2006

2006

2006

2008

N020403 001 Jan 31, 1995

A077545
A077545
A077545
A077303
A077303
A077303
A077729
A077729
A077729

001
002
003
001
002
004
001
002
003

Sep
Sep
Sep
Jun
Jun
Jun
Mar
Mar
Mar

06,
06,
06,
25,
25,
25,
28,
28,
28,

2007

2007

2007

2007

2007

2007

2011

2011

2011

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6-254(of 347)

DISCONTINUED DRUG PRODUCT LIST

ORPHENADRINE CITRATE

INJECTABLE;INJECTION

NORFLEX

IGI LABS INC
30MG/ML

ORPHENADRINE CITRATE

WATSON LABS
30MG/ML

TABLET, EXTENDED RELEASE;ORAL

NORFLEX

MEDICIS
100MG

ORPHENADRINE CITRATE

ASCOT
100MG

SANDOZ
100MG

WATSON LABS
100MG

N013055 001

A087062 001

N012157 001

A088067 001 Apr 06, 1983

A085046 001

A084303 001

ORPHENADRINE HYDROCHLORIDE

TABLET;ORAL

DISIPAL

3M

50MG

N010653 001

OSELTAMIVIR PHOSPHATE

FOR SUSPENSION;ORAL

TAMIFLU

ROCHE

EQ 12MG BASE/ML

N021246 001 Dec 14, 2000

EQ
EQ
EQ
EQ

250MG
250MG
500MG
500MG

BASE

BASE

BASE

BASE

A061336
A062241
A061336
A062241

001

001

002

002

EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG

BASE

BASE

BASE

BASE

A062222
A062222
A061450
A061450

001

002

002

001

OXACILLIN SODIUM

CAPSULE;ORAL

BACTOCILL

GLAXOSMITHKLINE

OXACILLIN SODIUM

ANI PHARMS INC
APOTHECON
PROSTAPHLIN

APOTHECON
FOR SOLUTION;ORAL

BACTOCILL

GLAXOSMITHKLINE
OXACILLIN SODIUM

APOTHECON
TEVA
PROSTAPHLIN

APOTHECON
INJECTABLE;INJECTION

BACTOCILL

GLAXOSMITHKLINE

OXACILLIN SODIUM

APOTHECON

ELKINS SINN

ISTITUTO BIO ITA SPA

SANDOZ

EQ 500MG BASE

N050118 002

EQ 250MG BASE/5ML

A062321 001

EQ 250MG BASE/5ML

EQ 250MG BASE/5ML

A061457 001

A062252 001

EQ 250MG BASE/5ML

N050194 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL

1GM BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

10GM BASE/VIAL

A061334
A061334
A062736
A061334
A062736
A061334
A061334

009
006
001
007
002
008
010

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

10GM BASE/VIAL

125MG BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

250MG BASE/VIAL

500MG BASE/VIAL

N050195
N050195
N050195
N050195
N050195
A062711
A062711
A062711
A062711
A062711
A062711
A062798
A062798
A062798
A062798
A062798
A061490
A061490

001

002

003

004

005

001
002
003
004
005
006
003
004
005
001
002
001

002

Mar
Mar
Dec
Mar
Dec
Mar

26,
26,
19,
26,
19,
26,

1982

1982

1986

1982

1986

1982

Feb
Feb
Feb
Feb
Feb
Feb
Dec
Dec
Dec
Dec
Dec

03,
03,
03,
03,
03,
03,
11,
11,
11,
11,
11,

1989

1989

1989

1989

1989

1989

1995

1995

1995

1995

1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-255(of 347)

DISCONTINUED DRUG PRODUCT LIST

OXACILLIN SODIUM

INJECTABLE;INJECTION

OXACILLIN SODIUM

WATSON LABS INC

OXALIPLATIN

INJECTABLE;IV (INFUSION)

ELOXATIN

SANOFI AVENTIS US

EQ
EQ
EQ
EQ
EQ
EQ

250MG BASE/VIAL

500MG BASE/VIAL

1GM BASE/VIAL

2GM BASE/VIAL

4GM BASE/VIAL

10GM BASE/VIAL

A062856
A062856
A062856
A062856
A062856
A062984

001
002
003
004
005
001

Oct
Oct
Oct
Oct
Oct
Sep

26,
26,
26,
26,
26,
29,

1988

1988

1988

1988

1988

1988

50MG/VIAL

100MG/VIAL

N021492 001 Aug 09, 2002

N021492 002 Aug 09, 2002

50MG/VIAL

100MG/VIAL

A090849 001 Apr 28, 2011

A090849 002 Apr 28, 2011

250MG

N018069 001

2.5MG

10MG

2.5MG

10MG

A077249
A077249
A076897
A076897

001
002
001
002

Jul
Jul
Dec
Dec

10,
10,
01,
01,

2007

2007

2006

2006

WATSON LABS

600MG

600MG

600MG

600MG

600MG

600MG

A075843
A075851
A075847
A075842
A075850
A075848

001
001
001
001
001
001

Oct
Aug
Feb
Apr
Apr
Feb

03,
17,
28,
12,
27,
09,

2001

2001

2001

2001

2001

2001

OXAPROZIN POTASSIUM

TABLET;ORAL

DAYPRO ALTA

GD SEARLE

600MG

N020776 001 Oct 17, 2002

10MG

15MG

30MG

10MG

15MG

30MG

10MG

15MG

30MG

10MG

15MG

30MG

10MG

15MG

30MG

A071955
A071956
A071957
A070943
A070944
A070945
A071026
A071026
A071026
A071713
A071714
A071715
A072952
A072953
A072954

10MG

15MG

30MG

N015539 002

N015539 004

N015539 006

10MG

15MG

30MG

A070650 001 Mar 01, 1988

A070640 001 Mar 01, 1988

A070641 001 Mar 01, 1988

OXALIPLATIN

SANDOZ
OXAMNIQUINE

CAPSULE;ORAL

VANSIL

PFIZER
OXANDROLONE

TABLET;ORAL

OXANDROLONE

ROXANE
SANDOZ
OXAPROZIN

TABLET;ORAL

OXAPROZIN

ACTAVIS ELIZABETH
MYLAN
MYLAN PHARMS INC
SANDOZ

OXAZEPAM

CAPSULE;ORAL

OXAZEPAM

AM THERAP

IVAX SUB TEVA PHARMS

MUTUAL PHARM

MYLAN

WATSON LABS

SERAX

ALPHARMA US PHARMS

ZAXOPAM

QUANTUM PHARMICS

001
001
001
001
001
001
002
003
001
001
001
001
001
001
001

Mar
Mar
Mar
Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Oct
Sep
Sep
Sep

03,
03,
03,
03,
03,
03,
10,
10,
10,
20,
20,
20,
28,
28,
28,

1988

1988

1988

1987

1987

1987

1987

1987

1987

1987

1987

1987

1990

1990

1990

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-256(of 347)

DISCONTINUED DRUG PRODUCT LIST

OXAZEPAM

TABLET;ORAL

OXAZEPAM

MUTUAL PHARM

PARKE DAVIS

WATSON LABS

SERAX

ALPHARMA US PHARMS

OXCARBAZEPINE

TABLET;ORAL

OXCARBAZEPINE

ANI PHARMS INC

OXPRENOLOL HYDROCHLORIDE

CAPSULE;ORAL

TRASICOR

NOVARTIS

OXTRIPHYLLINE

SOLUTION;ORAL

CHOLEDYL

PARKE DAVIS

OXTRIPHYLLINE

MORTON GROVE

SYRUP;ORAL

CHOLEDYL

PARKE DAVIS

OXTRIPHYLLINE PEDIATRIC

MORTON GROVE

TABLET, DELAYED RELEASE;ORAL

CHOLEDYL

PARKE DAVIS

OXTRIPHYLLINE

WATSON LABS

OXYBUTYNIN CHLORIDE

SYRUP;ORAL

DITROPAN

ORTHO MCNEIL JANSSEN

OXYBUTYNIN CHLORIDE

APOTEX INC

MIKART

TABLET;ORAL

DITROPAN

JANSSEN PHARMS

OXYBUTYNIN CHLORIDE

QUANTUM PHARMICS

USL PHARMA

WATSON LABS

15MG

15MG

15MG

A070683 001 Jan 16, 1987

A071508 001 Feb 02, 1987

A071494 001 Apr 21, 1987

15MG

N015539 008

150MG

300MG

600MG

A078005 001 Dec 11, 2007

A078005 002 Dec 11, 2007

A078005 003 Dec 11, 2007

20MG

40MG

80MG

160MG

N018166
N018166
N018166
N018166

100MG/5ML

N009268 012 Nov 27, 1984

100MG/5ML

A088243 001 Dec 05, 1983

50MG/5ML

N009268 011

50MG/5ML

A088242 001 Dec 05, 1983

100MG

200MG

N009268 003

N009268 007

100MG

200MG

A087866 001 Aug 25, 1983

A087835 001 Aug 25, 1983

5MG/5ML

N018211 001

5MG/5ML

5MG/5ML

A074997 001 Oct 15, 1997

A075039 001 Jan 29, 1999

5MG

N017577 001

5MG

5MG

5MG

A072296 001 Dec 08, 1988

A070746 001 Mar 10, 1988

A072485 001 Apr 19, 1989

OXYCODONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ROXICODONE

ROXANE

10MG

30MG

OXYMORPHONE HYDROCHLORIDE

INJECTABLE;INJECTION

OPANA

ENDO PHARMS

1.5MG/ML

SUPPOSITORY;RECTAL

NUMORPHAN

ENDO PHARMS

5MG

TABLET, EXTENDED RELEASE;ORAL

OPANA ER

ENDO PHARMS

5MG

7.5MG

001
002
003
004

Dec
Dec
Dec
Dec

28,
28,
28,
28,

1983

1983

1983

1983

N020932 001 Oct 26, 1998

N020932 002 Oct 26, 1998

N011707 001

N011738 004

N021610 001 Jun 22, 2006

N021610 005 Feb 29, 2008

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6-257(of 347)

DISCONTINUED DRUG PRODUCT LIST

OXYMORPHONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

OPANA ER

10MG
15MG
20MG
30MG
40MG
OXYPHENBUTAZONE

TABLET;ORAL

OXYPHENBUTAZONE

WATSON LABS
TANDEARIL

NOVARTIS

N021610
N021610
N021610
N021610
N021610

002
006
003
007
004

22,
29,
22,
29,
22,

2006

2008

2006

2008

2006

100MG

A088399 001 Sep 17, 1984

100MG

N012542 004 Sep 03, 1982

OXYPHENCYCLIMINE HYDROCHLORIDE

TABLET;ORAL

DARICON

PFIZER
10MG

N011612 001

OXYPHENONIUM BROMIDE

TABLET;ORAL

ANTRENYL

NOVARTIS

5MG

N008492 002

OXYTETRACYCLINE

TABLET;ORAL

TERRAMYCIN

PFIZER

250MG

N050287 001

OXYTETRACYCLINE CALCIUM

SYRUP;ORAL

TERRAMYCIN

PFIZER

EQ 125MG BASE/5ML

A060595 001

OXYTETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

OXY-KESSO-TETRA

FERRANTE
EQ
OXYTETRACYCLINE HYDROCHLORIDE

HIKMA PHARMS LLC
EQ
IMPAX LABS
EQ
PROTER
EQ
PUREPAC PHARM
EQ
TERRAMYCIN

PFIZER
EQ
EQ
INJECTABLE;INJECTION

TERRAMYCIN

PFIZER
EQ
EQ

250MG BASE

A060179 001

250MG
250MG
250MG
250MG

A060770
A060760
A060869
A060634

BASE
BASE
BASE
BASE

001

001

001

001

125MG BASE
250MG BASE

N050286 001

N050286 002

250MG BASE/VIAL
500MG BASE/VIAL

A060586 001

A060586 002

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE

OINTMENT;OTIC

TERRAMYCIN W/ POLYMYXIN

PFIZER
EQ 5MG BASE/GM;10,000 UNITS/GM
TABLET;VAGINAL

TERRAMYCIN-POLYMYXIN

PFIZER
EQ 100MG BASE;100,000 UNITS
OXYTOCIN

INJECTABLE;INJECTION

OXYTOCIN

TEVA PHARMS USA

Jun
Feb
Jun
Feb
Jun

10USP UNITS/ML (10USP UNITS/ML)

100USP UNITS/10ML (10USP UNITS/ML)
OXYTOCIN 10 USP UNITS IN DEXTROSE 5%

ABBOTT
1USP UNITS/100ML **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

2USP UNITS/100ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

ABBOTT
2USP UNITS/100ML **Federal Register

A061841 001

A061009 001

A077453 001 Jan 24, 2008

A077453 002 Jan 24, 2008

N019185 004 Mar 29, 1985

N019185 003 Mar 29, 1985

N019185 002 Mar 29, 1985

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6-258(of 347)

DISCONTINUED DRUG PRODUCT LIST

OXYTOCIN

INJECTABLE;INJECTION

OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

OXYTOCIN 5 USP UNITS IN DEXTROSE 5%

ABBOTT
1USP UNITS/100ML **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

SYNTOCINON

NOVARTIS
10USP UNITS/ML
SOLUTION;NASAL

SYNTOCINON

RTRX
40USP UNITS/ML

N012285 001

PACLITAXEL

INJECTABLE;INJECTION

PACLITAXEL

ACCORD HLTHCARE
HOSPIRA
MYLAN
PLIVA LACHEMA
TEVA PHARMS USA

A075436
A076233
A075278
A077413
A075297

6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML

PALIPERIDONE

TABLET, EXTENDED RELEASE;ORAL

INVEGA

JANSSEN PHARMS
12MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

PALONOSETRON HYDROCHLORIDE

CAPSULE;ORAL

ALOXI

HELSINN HLTHCARE

PAMIDRONATE DISODIUM

INJECTABLE;INJECTION

AREDIA

NOVARTIS

PAMIDRONATE DISODIUM

AESGEN
MN PHARMS

HOSPIRA
IGI LABS INC

PAVULON

ORGANON USA INC

N018245 001

001
001
001
001
001

Nov
Aug
Jan
Mar
Jan

12,
01,
25,
12,
25,

2004

2002

2002

2008

2002

N021999 004 Dec 19, 2006

EQ 0.5MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N022233 001 Aug 22, 2008

30MG/VIAL
60MG/VIAL
90MG/VIAL

N020036 001 Oct 31, 1991

N020036 003 May 06, 1993

N020036 004 May 06, 1993

30MG/VIAL
90MG/VIAL
30MG/VIAL
90MG/VIAL

A075594
A075594
A078300
A078300

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

CAPSULE;ORAL

COTAZYM

ORGANON USA INC
30000USPU;30000USPU;8000USPU
PANCURONIUM BROMIDE

INJECTABLE;INJECTION

PANCURONIUM BROMIDE

ELKINS SINN

N019185 001 Mar 29, 1985

001
002
001
002

May
May
Mar
Mar

06,
06,
10,
10,

2002

2002

2009

2009

N020580 001 Dec 09, 1996

1MG/ML
2MG/ML
2MG/ML
2MG/ML
1MG/ML
2MG/ML
2MG/ML
2MG/ML

A072058
A072059
A072060
A072321
A072210
A072211
A072212
A072213

001
001
001
001
001
001
001
001

1MG/ML
2MG/ML

N017015 002

N017015 001

Mar
Mar
Mar
Jan
Mar
Mar
Mar
Mar

23,
23,
23,
19,
31,
31,
31,
31,

1988

1988

1988

1989

1988

1988

1988

1988

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6-259(of 347)

DISCONTINUED DRUG PRODUCT LIST

PARAMETHADIONE

CAPSULE;ORAL

PARADIONE

ABBVIE
SOLUTION;ORAL

PARADIONE

ABBVIE
PARAMETHASONE ACETATE

TABLET;ORAL

HALDRONE

LILLY
PARGYLINE HYDROCHLORIDE

TABLET;ORAL

EUTONYL

ABBOTT

PAROMOMYCIN SULFATE

CAPSULE;ORAL

HUMATIN

KING PFIZER
PARKEDALE
SYRUP;ORAL

HUMATIN

PARKE DAVIS
PAROXETINE HYDROCHLORIDE

CAPSULE;ORAL

PAXIL

APOTEX TECHNOLOGIES

SUSPENSION;ORAL

PAROXETINE HYDROCHLORIDE

APOTEX INC
TABLET;ORAL

PAROXETINE HYDROCHLORIDE

ROXANE

SANDOZ

TEVA PHARMS

PAXIL

APOTEX TECHNOLOGIES

150MG
300MG

N006800 003

N006800 001

300MG/ML

N006800 002

1MG
2MG

N012772 005

N012772 006

10MG
25MG
50MG

N013448 002

N013448 003

N013448 004

EQ 250MG BASE
EQ 250MG BASE

A062310 001

A060521 001

EQ 125MG BASE/5ML

A060522 001

EQ 10MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

EQ 20MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

EQ 30MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

EQ 40MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

N020885 001 Oct 09, 1998

or

N020885 002 Oct 09, 1998

or

N020885 003 Oct 09, 1998

or

N020885 004 Oct 09, 1998

or

EQ 10MG BASE/5ML

A077395 001 Dec 05, 2006

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A078026
A078026
A078026
A078026
A075566
A075566
A075566
A075566
A077082
A077082
A077082
A077082

10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

EQ 50MG BASE

001
002
003
004
001
002
003
004
001
002
003
004

Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Jun
Jun
Jun
Jun

29,
29,
29,
29,
08,
08,
08,
08,
29,
29,
29,
29,

2007

2007

2007

2007

2004

2004

2004

2004

2007

2007

2007

2007

N020031 004 Dec 29, 1992

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6-260(of 347)

DISCONTINUED DRUG PRODUCT LIST

PAZOPANIB HYDROCHLORIDE

TABLET;ORAL

VOTRIENT

NOVARTIS PHARMS CORP

EQ 400MG BASE

N022465 002 Oct 19, 2009

PEGINESATIDE ACETATE

SOLUTION;INTRAVENOUS, SUBCUTANEOUS

OMONTYS
TAKEDA PHARMS USA
EQ 10MG BASE/ML (EQ 10MG BASE/ML)
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
OMONTYS PRESERVATIVE FREE
TAKEDA PHARMS USA
EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)
EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)
EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)
EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)
EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)

N202799
N202799
N202799
N202799
N202799
N202799

PEMIROLAST POTASSIUM
SOLUTION/DROPS;OPHTHALMIC
ALAMAST
SANTEN

0.1%

N021079 001 Sep 24, 1999

18.75MG
37.5MG
75MG

N016832 001
N016832 002
N016832 003

18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG

A075595
A075595
A075595
A075726
A075726
A075726
A075286
A075286
A075286
A075030
A075030
A075030
A075328
A075328
A075328
A075287
A075287
A075287

37.5MG

N017703 001

37.5MG
37.5MG

A075678 001 Jul 26, 2000

A075555 001 Feb 18, 2000

10MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**
20MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N018976 001 Dec 30, 1987

125MG

N019853 002

PEMOLINE
TABLET;ORAL
CYLERT
ABBOTT

PEMOLINE
ACTAVIS ELIZABETH

MALLINCKRODT

SANDOZ

TEVA PHARMS

VINTAGE PHARMS

WATSON LABS

TABLET, CHEWABLE;ORAL
CYLERT
ABBOTT
PEMOLINE
ACTAVIS ELIZABETH
TEVA PHARMS
PENBUTOLOL SULFATE
TABLET;ORAL
LEVATOL
AUXILIUM PHARMS LLC

PENICILLAMINE
CAPSULE;ORAL
CUPRIMINE
ATON

N202799 007 Mar 27, 2012

N202799 008 Mar 27, 2012
001
002
003
004
005
006

001
002
003
003
002
001
001
002
003
003
001
002
001
002
003
001
002
003

Mar
Mar
Mar
Mar
Mar
Mar

Feb
Feb
Feb
Mar
Mar
Mar
Dec
Jun
Jun
Feb
Jan
Jan
Apr
Apr
Apr
Jun
Sep
Sep

27,
27,
27,
27,
27,
27,

28,
28,
28,
30,
30,
30,
27,
30,
30,
22,
29,
29,
19,
19,
19,
13,
18,
18,

2012
2012
2012
2012
2012
2012

2000
2000
2000
2001
2001
2001
1999
1999
1999
2000
1999
1999
2000
2000
2000
2001
2000
2000

N018976 004 Jan 05, 1989

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6-261(of 347)

DISCONTINUED DRUG PRODUCT LIST

PENICILLIN G BENZATHINE

INJECTABLE;INJECTION

BICILLIN L-A

WYETH AYERST
SUSPENSION;ORAL

BICILLIN

WYETH AYERST
TABLET;ORAL

BICILLIN

WYETH AYERST
PENICILLIN G POTASSIUM

FOR SOLUTION;ORAL

PENICILLIN

TEVA
PENICILLIN G POTASSIUM

MYLAN

PUREPAC PHARM
PENICILLIN-2

TEVA
PENTIDS '200'

APOTHECON
PENTIDS '400'

APOTHECON
PFIZERPEN G

PFIZER
INJECTABLE;INJECTION

PENICILLIN G POTASSIUM

APOTHECON

CONSOLIDATED PHARM

LILLY

PARKE DAVIS
PFIZER
SANDOZ

WATSON LABS INC

PFIZERPEN

PFIZER

TABLET;ORAL

PENICILLIN G POTASSIUM

APOTHECON
IVAX SUB TEVA PHARMS
LILLY
MYLAN

PUREPAC PHARM

300,000 UNITS/ML

N050131 001

300,000 UNITS/5ML

N050126 002

200,000 UNITS

N050128 001

200,000 UNITS/5ML

400,000 UNITS/5ML

A060307 002

A060307 004

200,000
250,000
400,000
250,000
400,000

A060752
A060752
A060752
A061740
A061740

UNITS/5ML

UNITS/5ML

UNITS/5ML

UNITS/5ML

UNITS/5ML

003

002

001

001

002

250,000 UNITS/5ML

A060307 003

200,000 UNITS/5ML

A062149 001

400,000 UNITS/5ML

A062149 002

400,000 UNITS/5ML

A060587 001

1,000,000 UNITS/VIAL

5,000,000 UNITS/VIAL

10,000,000 UNITS/VIAL

20,000,000 UNITS/VIAL

500,000 UNITS/VIAL

1,000,000 UNITS/VIAL

5,000,000 UNITS/VIAL

10,000,000 UNITS/VIAL

200,000 UNITS/VIAL

500,000 UNITS/VIAL

1,000,000 UNITS/VIAL

5,000,000 UNITS/VIAL

20,000,000 UNITS/VIAL

20,000,000 UNITS/VIAL

1,000,000 UNITS/VIAL

5,000,000 UNITS/VIAL

20,000,000 UNITS/VIAL

1,000,000 UNITS/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

1,000,000 UNITS/VIAL

5,000,000 UNITS/VIAL

10,000,000 UNITS/VIAL

20,000,000 UNITS/VIAL

A060362
A060362
A060362
A060362
A060806
A060806
A060806
A060806
A060384
A060384
A060384
A060384
A060384
A060601
A062003
A062003
A060074
A065079

001

003

004

002

001

002

003

004

004

003

002

001

005

001

001

002

003

001
Aug 30, 2002

A062991
A062991
A062991
A062991

001

002

003

004

1,000,000 UNITS/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

A060657 001

250,000
400,000
250,000
200,000
250,000
400,000
500,000
800,000
200,000
250,000

A060392
A060073
A060403
A060781
A060781
A060781
A060781
A060781
A061588
A061588

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

003

004

001

001

002

003

005

004

001

002

Sep
Sep
Sep
Sep

13,
13,
13,
13,

1988

1988

1988

1988

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6-262(of 347)

DISCONTINUED DRUG PRODUCT LIST

PENICILLIN G POTASSIUM

TABLET;ORAL

PENICILLIN G POTASSIUM

TEVA

WYETH AYERST

PENTIDS '200'

APOTHECON

PENTIDS '250'

APOTHECON

PENTIDS '400'

APOTHECON

PENTIDS '800'

APOTHECON

PFIZERPEN G

PFIZER

PENICILLIN G PROCAINE

INJECTABLE;INJECTION

DURACILLIN A.S.

LILLY

PENICILLIN G PROCAINE

CONSOLIDATED PHARM

PARKE DAVIS

PFIZER

PFIZERPEN-AS

PFIZER

400,000
200,000
250,000
400,000
500,000
200,000
250,000
400,000

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

UNITS

PENICILLIN V POTASSIUM

FOR SOLUTION;ORAL

BEEPEN-VK

GLAXOSMITHKLINE

BETAPEN-VK

APOTHECON

LEDERCILLIN VK

LEDERLE

PEN-VEE K

WYETH AYERST

PENAPAR-VK

PARKE DAVIS

003

001

002

003

004

001

002

003

200,000 UNITS

A062155 001

250,000 UNITS

A062155 002

400,000 UNITS

400,000 UNITS

A060392 004

A062155 003

800,000 UNITS

800,000 UNITS

A060392 005

A062155 004

50,000 UNITS

100,000 UNITS

200,000 UNITS

250,000 UNITS

400,000 UNITS

800,000 UNITS

A060075
A060075
A060075
A060075
A060075
A060075

300,000 UNITS/ML

A060093 001

300,000 UNITS/ML

600,000 UNITS/1.2ML

300,000 UNITS/ML

300,000 UNITS/VIAL

1,500,000 UNITS/VIAL

A060800
A060800
A062029
A060099
A060099

300,000 UNITS/ML

600,000 UNITS/ML

A060286 001

A060286 002

PENICILLIN G SODIUM

INJECTABLE;INJECTION

PENICILLIN G SODIUM

BRISTOL MYERS SQUIBB
5,000,000
COPANOS

5,000,000
PHARMACIA AND UPJOHN
1,000,000
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

PENICILLIN G SODIUM

WATSON LABS INC

5,000,000
PENICILLIN V

FOR SUSPENSION;ORAL

V-CILLIN

LILLY

A061588
A060306
A060306
A060306
A060306
A060413
A060413
A060413

001

002

003

004

005

006

001

002

001

001

002

UNITS/VIAL

UNITS/VIAL

UNITS/VIAL

A061935 001

A061051 001

A061046 001

UNITS/VIAL

A063014 001 Sep 13, 1988

125MG/0.6ML

A060002 001

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

A062270 001

A062270 002

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

A061149 001

A061149 002

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

A060136 001

A060136 002

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

A060007 001

A060007 002

EQ 125MG BASE/5ML

A062002 001

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6-263(of 347)

DISCONTINUED DRUG PRODUCT LIST

PENICILLIN V POTASSIUM

FOR SOLUTION;ORAL

PENAPAR-VK

PENICILLIN V POTASSIUM

AM ANTIBIOTICS
MYLAN
PUREPAC PHARM
PFIZERPEN VK

PFIZER
V-CILLIN K

LILLY
VEETIDS

APOTHECON
VEETIDS '125'

APOTHECON
VEETIDS '250'

APOTHECON
TABLET;ORAL

BEEPEN-VK

GLAXOSMITHKLINE
BETAPEN-VK

BRISTOL
LEDERCILLIN VK

LEDERLE
PEN-VEE K

WYETH AYERST

PENAPAR-VK

PARKE DAVIS
PENICILLIN V POTASSIUM

AM ANTIBIOTICS
IVAX SUB TEVA PHARMS

MYLAN
PUREPAC PHARM

PFIZERPEN VK

PFIZER
UTICILLIN VK

PHARMACIA AND UPJOHN
V-CILLIN K

LILLY

VEETIDS

APOTHECON
VEETIDS '250'

APOTHECON
VEETIDS '500'

APOTHECON

EQ 250MG BASE/5ML

A062002 002

EQ
EQ
EQ
EQ
EQ
EQ

A061529
A061529
A061624
A061624
A061758
A061758

125MG
250MG
125MG
250MG
125MG
250MG

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

BASE/5ML

001

002

002

001

001

002

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

A061815 001

A061815 002

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

A060004 001

A060004 002

EQ 125MG BASE/5ML

EQ 250MG BASE/5ML

A061410 001

A061410 002

EQ 125MG BASE/5ML

EQ 125MG BASE/5ML

A061206 001

A062153 001

EQ 250MG BASE/5ML

EQ 250MG BASE/5ML

A061206 002

A062153 002

EQ 250MG BASE

EQ 500MG BASE

A062273 001

A062273 002

EQ 250MG BASE

EQ 500MG BASE

A061150 001

A061150 002

EQ 250MG BASE

EQ 500MG BASE

A060134 001

A060134 002

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A060006 001

A060006 002

A060006 003

EQ 250MG BASE

EQ 500MG BASE

A062001 001

A062001 002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A061528
A061528
A060518
A060518
A060518
A061530
A061530
A061571
A061571
A061571

250MG
500MG
125MG
250MG
500MG
250MG
500MG
125MG
250MG
500MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

001

002

001

002

003

001

002

001

002

003

EQ 250MG BASE

EQ 500MG BASE

A061836 001

A061836 002

EQ 250MG BASE

EQ 500MG BASE

A061651 001

A061651 002

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A060003 001

A060003 002

A060003 003

EQ 250MG BASE

EQ 500MG BASE

A061411 001

A061411 002

EQ 250MG BASE

EQ 250MG BASE

A061164 001

A062156 002

EQ 500MG BASE

A061164 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-264(of 347)

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PENICILLIN V POTASSIUM

TABLET;ORAL

VEETIDS '500'

PENTAGASTRIN

INJECTABLE;INJECTION

PEPTAVLON

WYETH AYERST

PENTAMIDINE ISETHIONATE

FOR SOLUTION;INHALATION

NEBUPENT

FRESENIUS KABI USA

INJECTABLE;INJECTION

PENTACARINAT

ARMOUR PHARM

PENTAMIDINE ISETHIONATE

BAXTER HLTHCARE

HOSPIRA

WATSON LABS

PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

TALWIN 50

SANOFI AVENTIS US

EQ 500MG BASE

A062156 001

0.25MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N017048 001

600MG/VIAL

N019887 002 Mar 22, 1996

300MG/VIAL

A073447 001 Apr 28, 1994

300MG/VIAL

300MG/VIAL

300MG/VIAL

A073617 001 Dec 18, 1995

A073479 001 Jun 30, 1992

A074303 001 Aug 17, 1995

EQ 50MG BASE

N016732 001

PENTETATE CALCIUM TRISODIUM

SOLUTION;INHALATION, INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMS
EQ 1GM BASE/5ML (EQ 200MG BASE/ML)

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

PENTETATE CALCIUM TRISODIUM YB-169

INJECTABLE;INJECTION

YTTERBIUM YB 169 DTPA

3M
2mCi/ML

PENTETATE ZINC TRISODIUM

SOLUTION;INHALATION, INTRAVENOUS

PENTETATE ZINC TRISODIUM

EQ 1GM BASE/5ML (EQ 200MG BASE/ML)

HAMELN PHARMS

**Federal Register determination that

product was not discontinued or

withdrawn for safety or efficacy

reasons**

PENTOBARBITAL

ELIXIR;ORAL

NEMBUTAL

OAK PHARMS

PENTOBARBITAL SODIUM

CAPSULE;ORAL

NEMBUTAL SODIUM

OAK PHARMS

PENTOBARBITAL SODIUM

LANNETT

VITARINE

WHITEWORTH TOWN PLSN

SODIUM PENTOBARBITAL

ANABOLIC

ELKINS SINN

EVERYLIFE

HALSEY

IVAX SUB TEVA PHARMS

PARKE DAVIS

PERRIGO

N021749 001 Aug 11, 2004

N017518 001

N021751 001 Aug 11, 2004

18.2MG/5ML

A083244 001

30MG

50MG

100MG

A084095 001

A084093 001

A083245 001

50MG

100MG

100MG

100MG

A085937
A085915
A083284
A083338

001

001

001

001

100MG

100MG

100MG

100MG

50MG

100MG

100MG

100MG

A084590
A083368
A083259
A084677
A083461
A083461
A084156
A084560

001

001

001

001

001

002

001

001

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6-265(of 347)

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PENTOBARBITAL SODIUM

CAPSULE;ORAL

SODIUM PENTOBARBITAL

PUREPAC PHARM

VALEANT PHARM INTL

WATSON LABS

WYETH AYERST

INJECTABLE;INJECTION

PENTOBARBITAL SODIUM

ELKINS SINN

SODIUM PENTOBARBITAL

WYETH AYERST

SUPPOSITORY;RECTAL

NEMBUTAL

OAK PHARMS

TABLET;ORAL

PENTOBARBITAL SODIUM

VITARINE

SODIUM PENTOBARBITAL

NEXGEN PHARMA INC

PENTOLINIUM TARTRATE

INJECTABLE;INJECTION

ANSOLYSEN

WYETH AYERST

100MG

100MG

100MG

100MG

A083301
A083264
A085791
A083239

50MG/ML

A083270 001

50MG/ML

A083261 001

30MG

60MG

120MG

200MG

A083247
A083247
A083247
A083247

100MG

A083285 001

100MG

A084238 001

10MG/ML

N009372 001

PENTOXIFYLLINE

TABLET, EXTENDED RELEASE;ORAL

PENTOXIFYLLINE

ACTAVIS ELIZABETH

400MG

HERITAGE PHARMS INC

400MG

TEVA

400MG

WATSON LABS

400MG

TRENTAL

SANOFI AVENTIS US

400MG

PERFLUBRON

LIQUID;ORAL

IMAGENT

ALLIANCE PHARM

100%

PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE

PASTE;TOPICAL

SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS

US ARMY

50%;50%

PERGOLIDE MESYLATE

TABLET;ORAL

PERGOLIDE MESYLATE

IVAX SUB TEVA PHARMS

PAR PHARM

PERMAX

VALEANT PHARM INTL

PERMETHRIN

LOTION;TOPICAL

NIX

GLAXOSMITHKLINE

PERPHENAZINE

CONCENTRATE;ORAL

PERPHENAZINE

PHARM ASSOC

TRILAFON

SCHERING

EQ
EQ
EQ
EQ
EQ
EQ

0.05MG BASE

0.25MG BASE

1MG BASE

0.05MG BASE

0.25MG BASE

1MG BASE

A074878
A074877
A075199
A075107

001

001

001

001

001
002
003
004

001
001
001
001

Jan
Jan
Jan
Jan

25,
25,
25,
25,

1982

1982

1982

1982

Jul
Jul
Sep
Sep

09,
08,
03,
04,

1997

1997

1999

1998

N018631 001 Aug 30, 1984

N020091 001 Aug 13, 1993

N021084 001 Feb 17, 2000

A076094
A076094
A076094
A076061
A076061
A076061

001
002
003
001
002
003

Sep
Sep
Sep
Nov
Nov
Nov

04,
04,
04,
27,
27,
27,

2003

2003

2003

2002

2002

2002

EQ 0.05MG BASE

EQ 0.25MG BASE

EQ 1MG BASE

N019385 001 Dec 30, 1988

N019385 002 Dec 30, 1988

N019385 003 Dec 30, 1988

1%

N019435 001 Mar 31, 1986

16MG/5ML

A040360 001 May 25, 2001

16MG/5ML

N011557 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-266(of 347)

DISCONTINUED DRUG PRODUCT LIST

PERPHENAZINE

INJECTABLE;INJECTION

TRILAFON

SCHERING
SYRUP;ORAL

TRILAFON

SCHERING
TABLET;ORAL

PERPHENAZINE

ANI PHARMS INC
TEVA PHARMS USA

5MG/ML

N011213 002

2MG/5ML

N011294 002

8MG

2MG

4MG

16MG

A089456
A089707
A089708
A089457

001

001

001

001

2MG

4MG

8MG

16MG

TABLET, EXTENDED RELEASE;ORAL

TRILAFON

SCHERING
8MG

N010775
N010775
N010775
N010775

001

002

003

004

TRILAFON

SCHERING

PHENACEMIDE

TABLET;ORAL

PHENURONE

ABBVIE

500MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE

TABLET;ORAL

AZO GANTANOL

ROCHE
100MG;500MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM

TABLET;ORAL

SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PENAZOPYRIDINE HYDROCHLORIDE

ABLE
200MG;800MG;160MG

PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE

TABLET;ORAL

AZO GANTRISIN

ROCHE
50MG;500MG **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

PHENDIMETRAZINE TARTRATE

CAPSULE;ORAL

PHENAZINE

MAST MM

PHENDIMETRAZINE TARTRATE

SANDOZ

VITARINE

SPRX-3

SOLVAY
STATOBEX

TEVA
X-TROZINE

SHIRE RICHWOOD

Sep
Sep
Sep
Sep

10,
10,
10,
10,

1987

1987

1987

1987

N011361 002

N007707 001

N013294 001
Sep 10, 1987

N021105 001
Jun 26, 2001

N019358 001
Aug 31, 1990

35MG

35MG

35MG

A086523 001

A086524 001

A086525 001

35MG

35MG

35MG

35MG

35MG

35MG

35MG

35MG

35MG

35MG

35MG

A085633
A085694
A085695
A085702
A085634
A085645
A085670
A086403
A086408
A086410
A087424

35MG

A085897 001

35MG

A085507 001

35MG

A087394 001
Sep 22, 1982

001

001

001

001

001

001

001

001

001

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-267(of 347)

DISCONTINUED DRUG PRODUCT LIST

PHENDIMETRAZINE TARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

BONTRIL

VALEANT

105MG

MELFIAT-105

NUMARK

105MG

PHENDIMETRAZINE TARTRATE

GRAHAM DM

105MG

105MG

105MG

105MG

105MG

105MG

SANDOZ

105MG

SPRX-105

NUMARK

105MG

X-TROZINE L.A.

SHIRE RICHWOOD

105MG

TABLET;ORAL

ADPHEN

FERNDALE LABS

35MG

ALPHAZINE

SANDOZ

35MG

CAM-METRAZINE

ABC HOLDING

35MG

CAMALL

35MG

TG UNITED LABS

35MG

35MG

35MG

35MG

DI-METREX

PVT FORM

35MG

MELFIAT

NUMARK

35MG

METRA

FOREST PHARMS

35MG

PHENAZINE

MAST MM

35MG

PHENAZINE-35

ABC HOLDING

35MG

PHENDIMETRAZINE TARTRATE

BARR

35MG

35MG

35MG

35MG

35MG

35MG

35MG

FERNDALE LABS

35MG

INWOOD LABS

35MG

35MG

35MG

35MG

IVAX PHARMS

35MG

35MG

IVAX SUB TEVA PHARMS
35MG

KV PHARM

35MG

35MG

35MG

MFG CHEMISTS

35MG

NEXGEN PHARMA INC

35MG

NUMARK

35MG

PVT FORM

35MG

35MG

SANDOZ

35MG

35MG

35MG

35MG

35MG

SOLVAY

35MG

TG UNITED LABS

35MG

35MG

A088021 001 Sep 21, 1982

A087487 001 Oct 13, 1982

A087214
A088020
A088028
A088062
A088063
A088111
A087378

001
001
001
001
001
001
001

May
Aug
Aug
Sep
Sep
Oct

26,
16,
16,
13,
10,
18,

1982

1982

1982

1982

1982

1982

A088024 001 Dec 22, 1982

A087371 001 Aug 24, 1982

A083655 001

A085034 001

A085511
A085756
A083922
A085318
A085320
A085321

001

001

001

001

001

001

A085698 001

A083790 002

A083754 001

A087305 001

A085512 001

A083644
A083684
A083686
A083687
A084831
A084834
A084835
A086834
A084740
A084741
A084742
A084743
A085611
A085612
A083682
A084138
A084141
A085525
A085914
A086020
A083790
A085199
A085697
A085402
A085497
A085830
A086365
A086370
A083993
A085761
A085941

001

001

001

001

001

001

001

001 Sep 15, 1983

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001 Jun 27, 1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-268(of 347)

DISCONTINUED DRUG PRODUCT LIST

PHENDIMETRAZINE TARTRATE

TABLET;ORAL

PHENDIMETRAZINE TARTRATE

USL PHARMA

VITARINE

WATSON LABS

PLEGINE

WYETH AYERST
STATOBEX

TEVA
STATOBEX-G

TEVA
X-TROZINE

SHIRE RICHWOOD

PHENINDIONE

TABLET;ORAL

HEDULIN

SANOFI AVENTIS US

35MG

35MG

35MG

35MG

35MG

35MG

35MG

35MG

35MG

35MG

A083805
A084398
A084399
A085519
A086005
A086106
A085767
A085768
A085770
A085773

35MG

N012248 001

35MG

A086013 001

35MG

A085095 001

35MG

35MG

35MG

35MG

35MG

A086550
A086551
A086552
A086553
A086554

50MG

N008767 002

PHENMETRAZINE HYDROCHLORIDE

TABLET;ORAL

PRELUDIN

BOEHRINGER INGELHEIM
25MG

TABLET, EXTENDED RELEASE;ORAL

PRELUDIN

BOEHRINGER INGELHEIM
50MG

75MG

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

N010460 005

N011752 004

N011752 003

PHENPROCOUMON

TABLET;ORAL

LIQUAMAR

ORGANON USA INC

3MG

N011228 001

PHENSUXIMIDE

CAPSULE;ORAL

MILONTIN

PARKE DAVIS

500MG

N008855 004

30MG

N017352 001

30MG

A087144 001

30MG

A087764 001 Mar 18, 1982

30MG

30MG

A086511 001

A086516 001

30MG

15MG

30MG

30MG

15MG

30MG

30MG

30MG

15MG

30MG

30MG

37.5MG

30MG

A085411
A040497
A040403
A040427
A086735
A087226
A088948
A086329
A040460
A040227
A040448
A040527
A087208

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL

FASTIN

GLAXOSMITHKLINE
OBESTIN-30

FERNDALE LABS
OBY-TRIM

SHIRE RICHWOOD
ONA-MAST

MAST MM
PHENTERMINE HYDROCHLORIDE

ABC HOLDING
ABLE

CAMALL
DURAMED PHARMS BARR
IVAX PHARMS
MIKAH PHARMA

MUTUAL PHARM
SANDOZ

001

001
001
001
001

001

001
001

001
001
001
001
001

Mar 13, 2003

Aug 30, 2001

Aug 30, 2001

Apr 25, 1986

Jan
Jun
Jan
Oct

14,
18,
22,
23,

2003

1997

2003

2003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-269(of 347)

DISCONTINUED DRUG PRODUCT LIST

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL

PHENTERMINE HYDROCHLORIDE

TEVA

TG UNITED INC
TG UNITED LABS

USL PHARMA

VITARINE
WATSON LABS
TABLET;ORAL

ONA-MAST

MAST MM
PHENTERMINE HYDROCHLORIDE

ABLE
ACTAVIS ELIZABETH
IVAX PHARMS
SANDOZ
SANDOZ INC
TG UNITED LABS

USL PHARMA

VITARINE
WATSON LABS

30MG
37.5MG
30MG
30MG
30MG
30MG
30MG
30MG
30MG
18.75MG
30MG
30MG
30MG
37.5MG
37.5MG
37.5MG
37.5MG
37.5MG
37.5MG
30MG
30MG
30MG
30MG
30MG
30MG

A087223
A088414
A086911
A087126
A087777
A088612
A088613
A088614
A040083
A088576
A085417
A086732
A087215
A087915
A087918
A087930
A088610
A088611
A088625
A084487
A088430
A088797
A087202
A087235
A086740

001

001
001

001

001
001
001
001
001
001
001

002

001

001
001
001
001
001
001
001
001
001
001

001

001

8MG

A086260 001

37.5MG
37.5MG
8MG
8MG
8MG
30MG
8MG
8MG
37.5MG
37.5MG
8MG
37.5MG
37.5MG
8MG
8MG
8MG

A040402
A040276
A085553
A085671
A085689
A088605
A083923
A085319
A087805
A088596
A083804
A088910
A088917
A086453
A086456
A085739

8MG

A084035 001

8MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N012737 001

001
001
001

001

001

001
001

001

001
001
001

001
001
001

001

001

Oct 19, 1983

Nov
Apr
Apr
Apr
Mar
May

01,
04,
09,
09,
07,
23,

1985

1984

1984

1984

1997

1984

Dec
Dec
Oct
Jun
Jun
Aug
Apr
Mar
Dec

22,
22,
14,
04,
04,
23,
09,
27,
10,

1983

1983

1983

1984

1984

1984

1982

1984

1984

Mar 21, 1985

Aug 30, 2001

Nov 25, 1998

Sep 28, 1987

Dec 06, 1982

Apr 04, 1984

Jul 17, 1985

Jul 17, 1985

TORA

SOLVAY
WILPO

SANDOZ

PHENTERMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE;ORAL

IONAMIN

UCB INC
EQ 15MG BASE
EQ 30MG BASE
PHENTERMINE RESIN 30

QUANTUM PHARMICS
EQ 30MG BASE
PHENYL AMINOSALICYLATE

POWDER;ORAL

PHENY-PAS-TEBAMIN

PHARM RES ASSOC
TABLET;ORAL

PHENY-PAS-TEBAMIN

PHARM RES ASSOC

N011613 004

N011613 002

A089120 001 Feb 04, 1988

50%

N011695 002

500MG

N011695 003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-270(of 347)

DISCONTINUED DRUG PRODUCT LIST

PHENYLBUTAZONE

CAPSULE;ORAL

AZOLID

SANOFI AVENTIS US

BUTAZOLIDIN

NOVARTIS

PHENYLBUTAZONE

IVAX PHARMS

MUTUAL PHARM

SANDOZ

WATSON LABS

TABLET;ORAL

AZOLID

SANOFI AVENTIS US

BUTAZOLIDIN

NOVARTIS

PHENYLBUTAZONE

MUTUAL PHARM

SANDOZ

WATSON LABS

100MG

A087260 001

100MG

N008319 009

100MG

100MG

100MG

100MG

A088218
A088994
A087774
A087756

100MG

A087091 001

100MG

N008319 008

100MG

100MG

100MG

100MG

A088863
A084339
A086151
A087674

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENERGAN VC

ANI PHARMS
5MG/5ML;6.25MG/5ML

PHERAZINE VC

HALSEY
5MG/5ML;6.25MG/5ML

PROMETHAZINE VC PLAIN

CENCI
5MG/5ML;6.25MG/5ML

WOCKHARDT
5MG/5ML;6.25MG/5ML

PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE

SOLUTION/DROPS;OPHTHALMIC

PREFRIN-A

ALLERGAN

0.12%;0.1%

PHENYTOIN

SUSPENSION;ORAL

DILANTIN-30

PARKE DAVIS

PHENYTOIN

ACTAVIS MID ATLANTIC

PHENYTOIN SODIUM

CAPSULE;ORAL

DIPHENYLAN SODIUM

LANNETT

EXTENDED PHENYTOIN SODIUM

ANI PHARMS INC

WOCKHARDT

WOCKHARDT USA

PHENYTEX

WATSON LABS

PHENYTOIN SODIUM

PHARMERAL

WATSON LABS

PROMPT PHENYTOIN SODIUM

ANI PHARMS INC

WATSON LABS

INJECTABLE;INJECTION

DILANTIN

PARKE DAVIS

PHENYTOIN SODIUM

FRESENIUS KABI USA

HOSPIRA

MARSAM PHARMS LLC

SMITH AND NEPHEW

SOLOPAK

WARNER CHILCOTT

001
001
001
001

Jun
Dec
Jun
Dec

24,
04,
16,
17,

1983

1985

1982

1982

001 Dec 04, 1985

001

001

001 Apr 21, 1982

N008604 003 Apr 02, 1984

A088868 001 Mar 02, 1987

A088815 001 Nov 22, 1985

A088897 001 Jan 04, 1985

N007953 001

30MG/5ML

N008762 002

125MG/5ML

A089892 001 Sep 25, 1992

30MG PROMPT

100MG PROMPT

A080857 001

A080857 002

100MG EXTENDED

100MG EXTENDED

30MG EXTENDED

100MG EXTENDED

A040435
A089441
A040759
A040732

100MG EXTENDED

A088711 001 Dec 21, 1984

100MG PROMPT

100MG PROMPT

A085435 001

A085894 001

100MG PROMPT

100MG PROMPT

A080259 001

A080905 001

50MG/ML

N010151 001

50MG/ML

50MG/ML

50MG/ML

50MG/ML

50MG/ML

50MG/ML

50MG/ML

50MG/ML

A089003
A089744
A089501
A089779
A088519
A088521
A088520
A089900

001
001
001
001

001
001
001
001
001
001
001
001

Jun
Dec
Dec
Jan

May
Dec
Oct
Nov
Dec
Dec
Dec
Mar

20,
18,
18,
30,

31,
18,
13,
27,
19,
18,
17,
30,

2003

1986

2007

2008

1985

1987

1987

1992

1984

1984

1984

1990

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-271(of 347)

DISCONTINUED DRUG PRODUCT LIST

PHENYTOIN SODIUM

INJECTABLE;INJECTION

PHENYTOIN SODIUM

WATSON LABS
PHYTONADIONE

INJECTABLE;INJECTION

AQUAMEPHYTON

IGI LABS INC
KONAKION

ROCHE
PHYTONADIONE

GLAXOSMITHKLINE
VITAMIN K1

HOSPIRA

50MG/ML

A085434 001

1MG/0.5ML
10MG/ML

N012223 002

N012223 001

1MG/0.5ML
10MG/ML

N011745 001

N011745 003

1MG/0.5ML
10MG/ML

A084060 001

A084060 002

10MG/ML

A087956 001 Jul 25, 1983

PILOCARPINE

INSERT, EXTENDED RELEASE;OPHTHALMIC

OCUSERT PILO-20

AKORN
5MG
OCUSERT PILO-40

AKORN
11MG
PILOCARPINE HYDROCHLORIDE

GEL;OPHTHALMIC

PILOPINE HS

ALCON

4%

PINACIDIL

CAPSULE, EXTENDED RELEASE;ORAL

PINDAC

LEO PHARM
12.5MG
25MG
PINDOLOL

TABLET;ORAL

PINDOLOL

G AND W LABS INC

MYLAN PHARMS INC

NOSTRUM LABS
PUREPAC PHARM
SANDOZ
WATSON LABS
VISKEN

NOVARTIS
PIPECURONIUM BROMIDE

INJECTABLE;INJECTION

ARDUAN

ORGANON USA INC
PIPERACETAZINE

TABLET;ORAL

QUIDE

DOW PHARM

N017431 001

N017548 001

N018796 001 Oct 01, 1984

N019456 001 Dec 28, 1989

N019456 002 Dec 28, 1989

5MG
5MG
5MG
10MG
10MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A073661
A073687
A074123
A073661
A073687
A074123
A074013
A074018
A074474
A074474
A074125
A074125
A073608
A073609
A074437
A074437

001
001
001
002
002
002
001
001
001
002
001
002
001
001
001
002

Oct
Feb
Apr
Oct
Feb
Apr
Sep
Sep
Oct
Oct
Apr
Apr
Mar
Mar
Feb
Feb

31,
26,
17,
31,
26,
17,
24,
24,
28,
28,
28,
28,
29,
29,
27,
27,

1993

1993

1997

1993

1993

1997

1992

1992

1996

1996

1993

1993

1993

1993

1995

1995

5MG
10MG

N018285 001 Sep 03, 1982

N018285 002 Sep 03, 1982

10MG/VIAL

N019638 001 Jun 26, 1990

10MG
25MG

N013615 001

N013615 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-272(of 347)

DISCONTINUED DRUG PRODUCT LIST

PIPERACILLIN SODIUM

INJECTABLE;INJECTION

PIPRACIL

WYETH PHARMS INC

PIPERAZINE CITRATE

SYRUP;ORAL

ANTEPAR

GLAXOSMITHKLINE
BRYREL

SANOFI AVENTIS US
MULTIFUGE

BLULINE
PIPERAZINE CITRATE

ALPHARMA US PHARMS
LANNETT
LUITPOLD
VERMIDOL

SOLVAY
TABLET;ORAL

ANTEPAR

GLAXOSMITHKLINE
PIPERAZINE CITRATE

IMPAX LABS

EQ
EQ
EQ
EQ
EQ
EQ
EQ

2GM BASE/VIAL
2GM BASE/VIAL
3GM BASE/VIAL
3GM BASE/VIAL
4GM BASE/VIAL
4GM BASE/VIAL
40GM BASE/VIAL

PIRBUTEROL ACETATE

AEROSOL, METERED;INHALATION

MAXAIR

MEDICIS
VALEANT PHARMS
PIROXICAM

CAPSULE;ORAL

PIROXICAM

CYCLE PHARMS LTD
EGIS
IVAX SUB TEVA PHARMS
MUTUAL PHARM
MYLAN
SCS
TEVA
TEVA PHARMS
WATSON LABS

001
002

002
003

003
004

006

EQ 500MG BASE/5ML

N009102 001

EQ 500MG BASE/5ML

N017796 001

EQ 500MG BASE/5ML

N009452 001

EQ 500MG BASE/5ML
EQ 500MG BASE/5ML
EQ 500MG BASE/5ML

A080774 001

A080963 001

A080671 001

EQ 500MG BASE/5ML

A080992 001

EQ 500MG BASE

N009102 003

EQ 250MG BASE

A080874 001

PIPERONYL BUTOXIDE; PYRETHRINS

AEROSOL;TOPICAL

RID MOUSSE

BAYER HEALTHCARE LLC
4%;EQ 0.33% BASE
PIPOBROMAN

TABLET;ORAL

VERCYTE

ABBOTT

A062750
N050545
A062750
N050545
A062750
N050545
N050545

Oct 13, 1987

Oct 13, 1987

Oct 13, 1987

Sep 30, 1985

N021043 001 Mar 07, 2000

10MG
25MG

N016245 001

N016245 002

EQ 0.2MG BASE/INH
EQ 0.2MG BASE/INH

N020014 001 Nov 30, 1992

N019009 001 Dec 30, 1986

10MG
20MG
10MG
20MG
10MG
20MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
10MG
20MG
20MG

A073651
A073651
A074808
A074808
A074148
A074148
A073536
A074043
A074043
A074036
A074036
A073637
A073638
A074103
A074103
A074287
A074460
A074287
A074460

001
002
001
002
001
002
001
001
002
001
002
001
001
001
002
001
001
002
002

Feb
Feb
Jul
Jul
Jun
Jun
Mar
Sep
Sep
May
May
Jan
Jan
Aug
Aug
May
Sep
May
Sep

26,
26,
08,
08,
03,
03,
12,
22,
22,
29,
29,
28,
28,
28,
28,
16,
29,
16,
29,

1993

1993

1997

1997

1996

1996

1993

1992

1992

1992

1992

1994

1994

1992

1992

1996

1995

1996

1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-273(of 347)

DISCONTINUED DRUG PRODUCT LIST

PLICAMYCIN

INJECTABLE;INJECTION

MITHRACIN

PFIZER

2.5MG/VIAL

N050109 001

POLYESTRADIOL PHOSPHATE

INJECTABLE;INJECTION

ESTRADURIN

WYETH AYERST

40MG/AMP

N010753 001

POLYETHYLENE GLYCOL 3350

FOR SOLUTION;ORAL

POLYETHYLENE GLYCOL 3350

PADDOCK LLC

TEVA PHARMS

17GM/SCOOPFUL
17GM/SCOOPFUL

A090567 001 Oct 15, 2009

A077445 001 May 04, 2006

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE

FOR SOLUTION;ORAL

CLENZ-LYTE
PADDOCK LLC
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
A090769 001 Jun 07, 2010
BOT;22.74GM/BOT
SOLUTION;ORAL
OCL
HOSPIRA
6GM/100ML;75MG/100ML;168MG/100ML;146MG/
N019284 001 Apr 30, 1986
100ML;1.29GM/100ML

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM
ANHYDROUS

FOR SOLUTION;ORAL

COLYTE

MEDA PHARMS

120GM/PACKET;1.49GM/PACKET;3.36GM/PACKE

N018983 005 Oct

T;2.92GM/PACKET;11.36GM/PACKET

227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC

N018983 004 Oct

KET;5.53GM/PACKET;21.5GM/PACKET

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/

N018983 007 Jun

BOT;22.72GM/BOT

360GM/PACKET;4.47GM/PACKET;10.08GM/PACK

N018983 006 Oct

ET;8.76GM/PACKET;34.08GM/PACKET

COLYTE-FLAVORED

MEDA PHARMS

227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G

N018983 008 Nov

M/BOT;21.5GM/BOT

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/

N018983 009 Nov

BOT;22.72GM/BOT

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/

PADDOCK LLC

A090712 001 Feb
BOT;22.72GM/BOT

FOR SUSPENSION;ORAL

CO-LAV

VINTAGE PHARMS

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/

A073428 001 Jan

BOT;22.72GM/BOT

COLOVAGE

DYNAPHARM

227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC

A071320 001 Apr

KET;5.53GM/PACKET;21.5GM/PACKET

E-Z-EM PREP LYTE

E Z EM

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/

A071278 001 Nov

BOT;22.74GM/BOT

GLYCOPREP

GOLDLINE

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/

A072319 001 Dec

BOT;22.74GM/BOT

GO-EVAC

VINTAGE PHARMS

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/

A073433 001 Apr

BOT;22.74GM/BOT

PEG-LYTE

SANDOZ

A073098 001 Aug
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/

BOT;22.74GM/BOT

POLYMYXIN B SULFATE

INJECTABLE;INJECTION

AEROSPORIN

GLAXOSMITHKLINE

POWDER;FOR RX COMPOUNDING

POLY-RX

X GEN PHARMS

POLYMYXIN B SULFATE

PADDOCK LLC

SULFATE

26, 1984

26, 1984

12, 1987

26, 1984

14, 1991

14, 1991

25, 2010

28, 1992

20, 1988

21, 1988

23, 1988

28, 1992

31, 1993

EQ 500,000 U BASE/VIAL

A062036 001

100,000,000 UNITS/BOT

A061578 001

100,000,000 UNITS/BOT

A062455 001 Jul 27, 1983

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6-274(of 347)

DISCONTINUED DRUG PRODUCT LIST

POLYTHIAZIDE

TABLET;ORAL

RENESE

PFIZER

1MG

2MG

4MG

N012845 001

N012845 002

N012845 003

POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

MINIZIDE

PFIZER

0.5MG;EQ 1MG BASE

0.5MG;EQ 2MG BASE

0.5MG;EQ 5MG BASE

N017986 001

N017986 002

N017986 003

POLYTHIAZIDE; RESERPINE

TABLET;ORAL

RENESE-R

PFIZER

2MG;0.25MG

N013636 001

500MG

N009395 004

100%

A080098 001

1GM

N009395 003

POTASSIUM AMINOSALICYLATE

CAPSULE;ORAL

PASKALIUM

GLENWOOD

POWDER;ORAL

POTASSIUM AMINOSALICYLATE

HEXCEL

TABLET;ORAL

PASKALIUM

GLENWOOD

POTASSIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

K-LEASE

SAVAGE LABS
8MEQ

10MEQ

POTASSIUM CHLORIDE

NESHER PHARMS
10MEQ

TEVA
8MEQ

10MEQ

FOR SUSPENSION, EXTENDED RELEASE;ORAL

MICRO-K LS

KV PHARM

20MEQ/PACKET

INJECTABLE;INJECTION

POTASSIUM CHLORIDE

ABRAXIS PHARM

2MEQ/ML

2MEQ/ML

2MEQ/ML

2MEQ/ML

2MEQ/ML

2MEQ/ML

AKORN

2MEQ/ML

BAXTER HLTHCARE

2MEQ/ML

FRESENIUS KABI USA

2MEQ/ML

GD SEARLE LLC

1MEQ/ML

2MEQ/ML

2MEQ/ML

3MEQ/ML

3MEQ/ML

4MEQ/ML

HOSPIRA

1MEQ/ML

1MEQ/ML

1.5MEQ/ML

2MEQ/ML

2.4MEQ/ML

3.2MEQ/ML

INTL MEDICATION

2MEQ/ML

LILLY

2MEQ/ML

LUITPOLD

2MEQ/ML

2MEQ/ML

2MEQ/ML

2MEQ/ML

MILES

1MEQ/ML

2MEQ/ML

3MEQ/ML

A073398 001 Jan 28, 1992

A072427 001 Mar 28, 1990

A070980 001 Feb 17, 1987

A073531 001 Apr 26, 1996

A073532 001 Apr 26, 1996

N019561 003 Aug 26, 1988

A080204
A084290
A086713
A086714
A087787
A087885
A088286
A080203
A087817
A086219
A086219
A086220
A086219
A086220
A086219
A080205
A083345
A083345
A083345
A080205
A080205
A083163
N007865
A080221
A080736
A087584
A087585
A080195
A080195
A080195

001

001

001

001

001
001
001
001

001
001

002

002

003

001

004

003

003

001

002

004

005

001

002

001

001

001

001

002

001

003

Apr 20, 1982

Feb 03, 1983

Sep 05, 1985

Oct 20, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-275(of 347)

DISCONTINUED DRUG PRODUCT LIST

POTASSIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE

4MEQ/ML
2MEQ/ML
2MEQ/ML
WATSON LABS
2MEQ/ML
2MEQ/ML
2MEQ/ML
3MEQ/ML
TABLET, EXTENDED RELEASE;ORAL

K+10

FUTURE PAK
10MEQ
K+8

FUTURE PAK
8MEQ
KAON CL

SAVAGE LABS
6.7MEQ
KAON CL-10

SAVAGE LABS
10MEQ
KLOTRIX

APOTHECON
10MEQ
POTASSIUM CHLORIDE

COPLEY PHARM
8MEQ
NESHER PHARMS
20MEQ
SCHERING
10MEQ
20MEQ
SLOW-K

NOVARTIS
8MEQ
TEN-K

NOVARTIS
10MEQ
PHARMA SERVE NY

A080195
A086297
A087362
A086208
A089163
A089421
A086210

004

001

001 Mar 08, 1983

001

001 Mar 10, 1988

001 Jan 02, 1987

001

A070999 001 Oct 22, 1987

A070998 001 Jan 25, 1993

N017046 001

N017046 002

N017850 001

A070618
A076044
N019439
N019439

001
001
002
001

Sep
Apr
Jun
Jun

09,
05,
13,
13,

1987

2002

1986

1986

N017476 002

N019381 001 Apr 16, 1986

POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
37MG/100ML;900MG/100ML
N019708
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
75MG/100ML;900MG/100ML
N019708
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
110MG/100ML;900MG/100ML
N019708
POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
220MG/100ML;900MG/100ML
N019708
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
300MG/100ML;900MG/100ML
N019708
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

B BRAUN
75MG/100ML;900MG/100ML
N018722
BAXTER HLTHCARE
75MG/100ML;900MG/100ML
N017648
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN
150MG/100ML;900MG/100ML
N018722
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

B BRAUN
220MG/100ML;900MG/100ML
N018722
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN
300MG/100ML;900MG/100ML
N018722

001 Sep 29, 1989

002 Sep 29, 1989

003 Sep 29, 1989

005 Sep 29, 1989

006 Sep 29, 1989

001 Nov 09, 1982

004

002 Nov 09, 1982

003 Nov 09, 1982

004 Nov 09, 1982

POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

INJECTABLE;INJECTION

THAM-E

HOSPIRA
370MG/VIAL;1.75GM/VIAL;36GM/VIAL

N013025 001

POTASSIUM CITRATE

FOR SOLUTION;ORAL

POTASSIUM CITRATE

UT SW MEDCTR

N019647 002 Oct 13, 1988

10MEQ/PACKET **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

20MEQ/PACKET **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N019647 001 Oct 13, 1988

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6-276(of 347)

DISCONTINUED DRUG PRODUCT LIST

POTASSIUM IODIDE

SOLUTION;ORAL

POTASSIUM IODIDE

ROXANE
TABLET;ORAL

THYRO-BLOCK

MEDPOINTE PHARM HLC
POTASSIUM PERCHLORATE

CAPSULE;ORAL

PERCHLORACAP

MALLINCKRODT
POVIDONE-IODINE

SOLUTION;TOPICAL

E-Z PREP

CLINIPAD
SPONGE;TOPICAL

E-Z PREP

CLINIPAD
E-Z PREP 220

CLINIPAD
PRALIDOXIME CHLORIDE

INJECTABLE;INJECTION

PRALIDOXIME CHLORIDE

BAXTER HLTHCARE CORP
TABLET;ORAL

PROTOPAM CHLORIDE

WYETH AYERST

1GM/ML

N018551 001 Feb 19, 1982

130MG

N018307 001

200MG

N017551 001

10%

N019382 001 Jul 25, 1989

5%

N019382 002 Jul 25, 1989

5%

N019382 003 Jul 25, 1989

300MG/ML

N018799 001 Dec 13, 1982

500MG

N014122 002

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET;ORAL

MIRAPEX

BOEHRINGER INGELHEIM
1.25MG
PRAMIPEXOLE DIHYDROCHLORIDE

WATSON LABS
0.125MG
0.25MG
0.5MG
1MG
1.5MG
PRAMLINTIDE ACETATE

INJECTABLE;SUBCUTANEOUS

SYMLIN

ASTRAZENECA AB
PRAVASTATIN SODIUM

TABLET;ORAL

PRAVACHOL

BRISTOL MYERS SQUIBB

PRAVASTATIN SODIUM

PLIVA HRVATSKA DOO

RANBAXY LABS LTD

PRAZEPAM

CAPSULE;ORAL

CENTRAX

PARKE DAVIS

PRAZEPAM

USL PHARMA
TABLET;ORAL

CENTRAX

PARKE DAVIS

N020667 004 Jul 01, 1997

A078551
A078551
A078551
A078551
A078551

001
002
003
004
005

Oct
Oct
Oct
Oct
Oct

08,
08,
08,
08,
08,

2010

2010

2010

2010

2010

EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)

N021332 001 Mar 16, 2005

10MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N019898 002 Oct 31, 1991

10MG
20MG
30MG
40MG
10MG
20MG
40MG
80MG

A077730
A077730
A077730
A077730
A076445
A076445
A076445
A076445

5MG
10MG
20MG

N018144 001

N018144 002

N018144 003 May 10, 1982

5MG
10MG

A070427 001 Nov 06, 1987

A070428 001 Nov 06, 1987

10MG

N017415 001

001
002
003
005
001
002
003
004

Nov
Nov
Nov
Nov
Apr
Apr
Apr
Apr

21,
21,
21,
21,
23,
23,
23,
23,

2006

2006

2006

2006

2007

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-277(of 347)

DISCONTINUED DRUG PRODUCT LIST

PRAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

PRAZOSIN HYDROCHLORIDE

AM THERAP

EQ 1MG
EQ 2MG
EQ 5MG
DAVA PHARMS INC

EQ 1MG
EQ 2MG
EQ 5MG
PUREPAC PHARM

EQ 1MG
EQ 2MG
EQ 5MG
SANDOZ

EQ 1MG
EQ 2MG
EQ 5MG
WATSON LABS

EQ 1MG
EQ 2MG
EQ 5MG
TABLET, EXTENDED RELEASE;ORAL

MINIPRESS XL

PFIZER

2.5MG

5MG

PREDNISOLONE

CREAM;TOPICAL

METI-DERM

SCHERING

SYRUP;ORAL

PREDNISOLONE

APOTEX INC

IVAX SUB TEVA PHARMS

NESHER PHARMS

TEVA PHARMS

WE PHARMS

PRELONE

MURO

TABLET;ORAL

CORTALONE

HALSEY

DELTA-CORTEF

PHARMACIA AND UPJOHN

FERNISOLONE-P

FERNDALE LABS

PREDNISOLONE

BARR

BUNDY

ELKINS SINN

EVERYLIFE

FERRANTE

HEATHER

IMPAX LABS

INWOOD LABS

IVAX SUB TEVA PHARMS

LANNETT

MARSHALL PHARMA

PANRAY

PERRIGO

PHOENIX LABS NY

PUREPAC PHARM

PVT FORM

ROXANE

SANDOZ

SPERTI

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

A072782
A072783
A072784
A072705
A072706
A072707
A072991
A072921
A072992
A072576
A072577
A072578
A072352
A072333
A072609

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

May
May
May
May
May
May
May
May
May
May
May
May
May
May
May

16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

1989

N019775 001 Jan 29, 1992

N019775 002 Jan 29, 1992

0.5%

N010209 002

5MG/5ML

15MG/5ML

15MG/5ML

5MG/5ML

15MG/5ML

15MG/5ML

15MG/5ML

A040570
A040571
A040287
A040423
A040364
A040322
A040192

5MG/5ML

A089654 001 Jan 17, 1989

1MG

2.5MG

5MG

A080304 003

A080304 002

A080304 001

5MG

N009987 004

5MG

A083941 001

5MG

5MG

5MG

1MG

2.5MG

5MG

2.5MG

5MG

5MG

5MG

5MG

5MG

5MG

5MG

1MG

5MG

5MG

5MG

5MG

5MG

5MG

5MG

5MG

1MG

2.5MG

A084426
A083675
A080625
A084439
A084439
A084439
A080562
A080562
A080326
A080780
A080748
A080378
A080531
A080307
A080351
A080351
A084542
A080322
A080325
A080211
A080327
A080339
A084773
A080358
A080358

001
001
001
001
001
001
001

002

001

001

001

002

003

001

002

001

001

001

001

002

001

001

002

001

001

001

001

002

001

001

001

002

Aug
Aug
May
Oct
Apr
Jan
May

25,
25,
28,
22,
10,
19,
28,

2005

2005

1999

2001

2002

2000

1998

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-278(of 347)

DISCONTINUED DRUG PRODUCT LIST

PREDNISOLONE

TABLET;ORAL

PREDNISOLONE

SUPERPHARM

TABLICAPS

TEVA

UDL

VALEANT PHARM INTL

VITARINE

WATSON LABS

WEST WARD

WHITEWORTH TOWN PLSN

STERANE

PFIZER

PREDNISOLONE ACETATE

INJECTABLE;INJECTION

METICORTELONE

SCHERING

PREDNISOLONE ACETATE

AKORN

BEL MAR

CENT PHARMS

WATSON LABS

STERANE

PFIZER

SUSPENSION;ORAL

FLO-PRED

TARO

SUSPENSION/DROPS;OPHTHALMIC

ECONOPRED

ALCON

5MG

5MG

5MG

5MG

5MG

5MG

5MG

5MG

5MG

5MG

5MG

5MG

A080358
A088892
A085170
A080398
A087987
A080236
A080534
A085085
A085415
A085416
A080324
A080342

5MG

N009996 001

25MG/ML

N010255 002

25MG/ML

50MG/ML

25MG/ML

50MG/ML

25MG/ML

50MG/ML

25MG/ML

25MG/ML

40MG/ML

50MG/ML

50MG/ML

A083032
A084492
A083738
A083738
A084717
A084717
A083398
A083654
A083767
A083764
A085781

25MG/ML

N011446 001

EQ 5MG BASE/5ML

EQ 15MG BASE/5ML

N022067 001 Jan 17, 2008

N022067 002 Jan 17, 2008

0.125%

N017468 001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

OINTMENT;OPHTHALMIC

CETAPRED

ALCON

0.25%;10%

METIMYD

SCHERING

0.5%;10%

PREDSULFAIR

PHARMAFAIR

0.5%;10%

VASOCIDIN

NOVARTIS

0.5%;10%

SUSPENSION;OPHTHALMIC

ISOPTO CETAPRED

ALCON

0.25%;10%

SUSPENSION/DROPS;OPHTHALMIC

METIMYD

SCHERING

0.5%;10%

PREDAMIDE

AKORN

0.5%;10%

PREDSULFAIR

PHARMAFAIR

0.5%;10%

PREDSULFAIR II

PHARMAFAIR

0.2%;10%

SULPHRIN

BAUSCH AND LOMB

0.5%;10%

003

001 Feb 26, 1985

001

001

001 Jan 18, 1983

001

001

002

001

001

001

001

001

001

001

002

001

002

001

001

001

001

001

A087771 001 Aug 06, 1993

N010210 002 Sep 09, 1984

A088032 001 Apr 15, 1983

A088791 001 Oct 05, 1984

A087547 001

N010210 001

A088059 001 Jul 29, 1983

A088007 001 Apr 19, 1983

A088837 001 Dec 24, 1985

A088089 001 Dec 28, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-279(of 347)

DISCONTINUED DRUG PRODUCT LIST

PREDNISOLONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

HYDELTRASOL

MERCK
EQ
PREDNISOLONE SODIUM PHOSPHATE

WATSON LABS
EQ
OINTMENT;OPHTHALMIC, OTIC

HYDELTRASOL

MERCK
EQ
SOLUTION;ORAL

PREDNISOLONE SODIUM PHOSPHATE

MEDICIS PHARMS

EQ
NESHER PHARMS

EQ
EQ
PHARM ASSOC

EQ
VINTAGE PHARMS

EQ
WE PHARMS

EQ
SOLUTION/DROPS;OPHTHALMIC

INFLAMASE FORTE

NOVARTIS

EQ
INFLAMASE MILD

NOVARTIS

EQ
METRETON

SCHERING

EQ
PREDAIR

PHARMAFAIR

EQ
PREDAIR FORTE

PHARMAFAIR

EQ
PREDNISOLONE SODIUM PHOSPHATE

AKORN

EQ
EQ
ALCON PHARMS LTD

EQ
EQ
BAUSCH AND LOMB

EQ
SOLA BARNES HIND

EQ
EQ
EQ
EQ

20MG PHOSPHATE/ML

N011583 002

20MG PHOSPHATE/ML

A080517 001

0.25% PHOSPHATE

N011028 001

15MG BASE/5ML

5MG BASE/5ML

15MG BASE/5ML

5MG BASE/5ML

5MG BASE/5ML

5MG BASE/5ML

A075250
A076982
A076988
A076123
A078416
A075181

0.9% PHOSPHATE

A080751 002

0.11% PHOSPHATE

A080751 001

0.5% PHOSPHATE

A083834 001

0.11% PHOSPHATE

A088415 001
Feb 29, 1984

0.9% PHOSPHATE

A088165 001
Mar 28, 1983

0.11% PHOSPHATE

0.9% PHOSPHATE

0.11% PHOSPHATE

0.9% PHOSPHATE

0.11% PHOSPHATE

0.11% PHOSPHATE

0.9% PHOSPHATE

0.9% PHOSPHATE

0.9% PHOSPHATE

A083358
A083358
A081043
A081044
A040065
A084171
A084168
A084169
A084172

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC

SULSTER

AKORN

EQ 0.23% PHOSPHATE;10%

VASOCIDIN

NOVARTIS

EQ 0.23% PHOSPHATE;10% **Federal

Register determination that product was

not discontinued or withdrawn for

safety or efficacy reasons**

PREDNISOLONE TEBUTATE

INJECTABLE;INJECTION

HYDELTRA-TBA

MERCK

PREDNISOLONE TEBUTATE

WATSON LABS

PREDNISONE

SOLUTION;ORAL

PREDNISONE

WOCKHARDT

SYRUP;ORAL

LIQUID PRED

MURO

TABLET;ORAL

CORTAN

HALSEY

DELTA-DOME

BAYER PHARMS

DELTASONE

PHARMACIA AND UPJOHN

001

001

001

001

001

001

Jul
May
May
Dec
Oct
Dec

12,
24,
24,
23,
31,
23,

2002

2005

2005

2002

2007

2002

001

002

001
Oct 24, 1991

001
Oct 24, 1991

001
Jul 29, 1994

001

001

001

001

A074511 001
Jul 30, 1996

N018988 001
Aug 26, 1988

20MG/ML

N010562 001

20MG/ML

A083362 001
Feb 17, 1984

5MG/5ML

A089726 001
Aug 02, 1988

5MG/5ML

A087611 002
Sep 07, 1982

20MG

A087480 001

5MG

A080293 001

2.5MG

5MG

10MG

20MG

50MG

N009986
N009986
N009986
N009986
N009986

005

002

006

007

008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-280(of 347)

DISCONTINUED DRUG PRODUCT LIST

PREDNISONE

TABLET;ORAL

FERNISONE

FERNDALE LABS
METICORTEN

SCHERING
ORASONE

SOLVAY

PARACORT

PARKE DAVIS
PREDNICEN-M

SCHWARZ PHARMA
PREDNISONE

AM THERAP

AMNEAL PHARMS NY

BUNDY
DURAMED PHARMS BARR

ELKINS SINN
EVERYLIFE

FERRANTE
HALSEY
HEATHER

HIKMA PHARMS
IMPAX LABS
INWOOD LABS

IVAX SUB TEVA PHARMS

KV PHARM
LANNETT
LEDERLE
MARSHALL PHARMA
MUTUAL PHARM

NYLOS
PANRAY

PERRIGO
PHARMAVITE
PHOENIX LABS NY
PUREPAC PHARM

PVT FORM
REXALL
ROXANE

5MG

A083364 001

1MG

5MG

N009766 002

N009766 001

1MG

5MG

10MG

20MG

50MG

A083009
A083009
A083009
A083009
A085999

5MG

N010962 002

5MG

A084655 001

5MG

10MG

20MG

5MG

10MG

20MG

5MG

5MG

10MG

20MG

5MG

20MG

1MG

2.5MG

5MG

2.5MG

5MG

5MG

5MG

10MG

20MG

20MG

50MG

1MG

5MG

1MG

2.5MG

5MG

5MG

10MG

20MG

5MG

5MG

20MG

5MG

5MG

5MG

10MG

20MG

50MG

5MG

1MG

2.5MG

5MG

5MG

5MG

5MG

20MG

5MG

10MG

20MG

20MG

5MG

20MG

A089387
A089388
A089389
A089597
A089598
A089599
A083676
A088394
A088395
A088396
A080491
A085811
A084440
A084440
A084440
A080563
A080563
A080300
A080320
A084341
A084417
A085543
A086946
A040890
A080782
A080328
A080306
A080279
A080283
A084133
A084134
A084236
A080514
A084275
A086968
A080301
A080701
A086595
A084634
A086596
A085115
A080350
A080350
A080350
A083059
A084662
A080321
A083807
A080353
A086062
A086061
A085151
A080232
N017109

001

002

003

004

001

001
001
001
001
001
001
001

001
001
001
001

001

001

002

003

001

002

001

001

001

001

001

001

001
001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

002

003

001

002

001

001

001

001

001

001

001

001

Nov
Nov
Nov
Oct
Oct
Oct

06,
06,
06,
05,
05,
05,

1986

1986

1986

1987

1987

1987

Oct 04, 1983

Oct 04, 1983

Oct 04, 1983

Nov 01, 2010

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-281(of 347)

DISCONTINUED DRUG PRODUCT LIST

PREDNISONE

TABLET;ORAL

PREDNISONE

SANDOZ

SCHERER LABS

SPERTI

SUPERPHARM

TEVA

UDL

UPSHER SMITH

VALEANT PHARM INTL

VANGARD

VITARINE

WATSON LABS

WHITEWORTH TOWN PLSN

SERVISONE

LEDERLE

PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CITANEST

ASTRAZENECA

CITANEST PLAIN

ASTRAZENECA

CITANEST PLAIN DENTAL

DENTSPLY PHARM

PRIMIDONE

SUSPENSION;ORAL

MYSOLINE

NURO PHARMA

TABLET;ORAL

PRIMIDONE

DR REDDYS LABS LTD

HIKMA PHARMS LLC

WATSON LABS

PROBENECID

TABLET;ORAL

BENEMID

MERCK

PROBENECID

IVAX SUB TEVA PHARMS

LEDERLE

WATSON LABS

25MG

5MG

5MG

10MG

20MG

50MG

5MG

1MG

2.5MG

5MG

5MG

10MG

20MG

5MG

5MG

10MG

20MG

5MG

20MG

5MG

5MG

20MG

5MG

5MG

5MG

10MG

20MG

50MG

50MG

2.5MG

5MG

10MG

20MG

A087833
A080336
A084774
A089983
A085813
A089984
A080371
A080359
A080359
A080359
A088865
A088866
A088867
A080397
A087984
A087985
A087986
A087471
A087470
A080237
A087682
A087701
A080334
A080506
A085084
A087773
A086813
A086867
A087772
A084913
A080343
A089028
A084913

001
002

001

001
001

001
001

001

002

003

001
001
001
001

001
001
001
001

001

001

001
001
001

001

002

001
001

001

001
001

001

001
002

May 04, 1982

5MG

A080223 001

1%

2%

3%

N014763 004

N014763 005

N014763 003

4%

N014763 007

4%

N021382 001

250MG/5ML

N010401 001

50MG

250MG

50MG

250MG

A040862
A040862
A040667
A085052

500MG

N007898 004

500MG

500MG

500MG

A083740 001 May 09, 1984

A086917 001

A086150 002 Apr 23, 1982

Jan 12, 1989

Jan 12, 1989

Oct 25, 1984

Oct 25, 1984

Oct 25, 1984

Jan 18, 1983

Jan 18, 1983

Jan 18, 1983

Jan 15, 1982

Jan 15, 1982

Jul 13, 1982

Jul 13, 1982

Jul 24, 1986

001 Oct 03, 2008

002 Oct 03, 2008

001 Jul 27, 2006

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-282(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROBUCOL

TABLET;ORAL

LORELCO

SANOFI AVENTIS US

250MG

500MG

PROCAINAMIDE HYDROCHLORIDE

CAPSULE;ORAL

PROCAINAMIDE HYDROCHLORIDE

ASCOT

250MG

375MG

500MG

IDT AUSTRALIA LTD

250MG

500MG

IVAX SUB TEVA PHARMS
250MG

375MG

500MG

LANNETT

250MG

500MG

LEDERLE

250MG

375MG

500MG

ROXANE

250MG

500MG

SANDOZ

375MG

VANGARD

250MG

500MG

WATSON LABS

250MG

250MG

250MG

375MG

375MG

500MG

500MG

500MG

PROCAN

PARKE DAVIS

250MG

375MG

500MG

PROCAPAN

PANRAY

250MG

PRONESTYL

APOTHECON

250MG

375MG

500MG

INJECTABLE;INJECTION

PROCAINAMIDE HYDROCHLORIDE

ABRAXIS PHARM

100MG/ML

500MG/ML

HIKMA MAPLE

100MG/ML

500MG/ML

HOSPIRA

500MG/ML

INTL MEDICATION

100MG/ML

500MG/ML

PHARMAFAIR

100MG/ML

500MG/ML

SMITH AND NEPHEW

100MG/ML

500MG/ML

SOLOPAK

500MG/ML

WARNER CHILCOTT

100MG/ML

500MG/ML

WATSON LABS

100MG/ML

500MG/ML

PRONESTYL

APOTHECON

100MG/ML

500MG/ML

TABLET;ORAL

PRONESTYL

APOTHECON

250MG

375MG

500MG

N017535 001

N017535 002 Jul 06, 1988

A087542
A087697
A087543
A089219
A089221
A084604
A084595
A084606
A083693
A084696
A086942
A086952
A086943
A088989
A088990
A089220
A087643
A087875
A083287
A083795
A085167
A084403
A087020
A084280
A084357
A087021

001
001
001
001
001
001

001

001

001

001

001

001

001

001
001
001
001
001
001

001

001

001

001

001

001

001

Jan
Mar
Jan
Jul
Jul

08,
01,
08,
01,
01,

1982

1983

1982

1986

1986

Apr
Apr
Jul
Jun
Jun

26,
26,
01,
01,
01,

1985

1985

1986

1982

1982

Nov
Nov
Apr
Apr
Aug
Jul
Jul
Nov
Nov
Mar
Mar
Mar
May
May

17,
17,
17,
17,
25,
31,
31,
20,
20,
04,
04,
04,
03,
03,

1986

1986

1986

1986

1987

1984

1984

1985

1985

1985

1985

1985

1988

1988

A085804 001

A087502 001

A085079 001

A083553 002

N007335 001

N007335 004

N007335 003

A089415
A089416
A089029
A089030
A089537
A088636
A088637
A088824
A088830
A088530
A088531
A088532
A089528
A089529
A087079
A087080

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

001

N007335 002

N007335 005

N017371 001

N017371 002

N017371 003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-283(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROCAINAMIDE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

PROCAINAMIDE HYDROCHLORIDE

ANI PHARMS INC

250MG

500MG

500MG

750MG

1GM

IDT AUSTRALIA LTD

250MG

500MG

750MG

INWOOD LABS

500MG

SANDOZ

500MG

WATSON LABS

250MG

250MG

500MG

500MG

750MG

750MG

1GM

PROCAN SR

PARKE DAVIS

250MG

PARKEDALE

500MG

750MG

1GM

PROCANBID

500MG

KING PHARMS

1GM

PRONESTYL-SR

500MG

APOTHECON

PROCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

NOVOCAIN

HOSPIRA

PROCAINE HYDROCHLORIDE

ABRAXIS PHARM

BEL MAR

ELKINS SINN

GD SEARLE LLC

HOSPIRA

MILES

WATSON LABS

A088958
A088959
A088974
A089438
A040111
A089369
A089370
A089371
A089840
A089284
A088533
A089026
A088534
A089027
A088535
A089042
A089520

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

A086468
A086065
A087510
A088489

001

001

001 Apr 01, 1982

001 Jan 16, 1985

A087361 001

A085362 003

A085362 004

A086797 001

1%

1%

2%

2%

1%

2%

1%

2%

1%

2%

1%

2%

1%

2%

1%

1%

2%

2%

A080384
A080421
A080384
A080421
A080711
A080756
A083315
A083315
A086202
A086202
A080416
A080416
A080415
A080415
A080658
A083535
A080658
A083535

PROCAINE MERETHOXYLLINE; THEOPHYLLINE

INJECTABLE;INJECTION

DICURIN PROCAINE

LILLY
100MG/ML;50MG/ML

02,
02,
22,
23,
13,
14,
09,
14,
06,
23,
03,
22,
03,
22,
03,
22,
15,

1985

1985

1985

1987

1996

1987

1987

1987

1989

1986

1984

1985

1984

1985

1984

1985

1987

N020545 001 Jan 31, 1996

N020545 002 Jan 31, 1996

1%

2%

10%

PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE

INJECTABLE;INJECTION

ACHROMYCIN

LEDERLE

40MG/VIAL;100MG/VIAL

40MG/VIAL;250MG/VIAL

TETRACYN

PFIZER

40MG/VIAL;100MG/VIAL

40MG/VIAL;250MG/VIAL

Dec
Dec
Jul
Mar
Dec
Aug
Jan
Aug
Mar
Jun
Dec
Oct
Dec
Oct
Nov
Oct
Jan

002

001

003

002

001

001

001

002

001

002

001

002

001

002

001

001

002

002

N050276 001

N050276 003

A060285 002

A060285 003

N008869 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-284(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROCHLORPERAZINE

SUPPOSITORY;RECTAL

COMPAZINE

GLAXOSMITHKLINE

PROCHLORPERAZINE

ABLE

PROCHLORPERAZINE EDISYLATE

CONCENTRATE;ORAL

COMPAZINE

GLAXOSMITHKLINE
PROCHLORPERAZINE

ALPHARMA US PHARMS
PROCHLORPERAZINE EDISYLATE

MORTON GROVE
INJECTABLE;INJECTION

COMPAZINE

GLAXOSMITHKLINE
PROCHLORPERAZINE

BAXTER HLTHCARE
PROCHLORPERAZINE EDISYLATE

HIKMA MAPLE
HOSPIRA
MARSAM PHARMS LLC
SMITH AND NEPHEW
TEVA PARENTERAL
WATSON LABS

2.5MG
5MG
25MG

N011127 003

N011127 001

N011127 002

2.5MG
5MG
25MG

A040407 001 Jul 11, 2001

A040407 002 Jul 11, 2001

A040407 003 Jul 11, 2001

EQ 10MG BASE/ML

N011276 001

EQ 10MG BASE/ML

A087153 001 Jun 08, 1982

EQ 10MG BASE/ML

A088598 001 Oct 25, 1984

EQ 5MG BASE/ML

N010742 002

EQ 5MG BASE/ML

A087759 001 Oct 01, 1982

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A089523
A089703
A089675
A089251
A040505
A089530
A089605
A089606
A086348

5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

WYETH AYERST
SYRUP;ORAL

COMPAZINE

GLAXOSMITHKLINE
EQ 5MG BASE/5ML
PROCHLORPERAZINE EDISYLATE

ALPHARMA US PHARMS
EQ 5MG BASE/5ML
MORTON GROVE
EQ 5MG BASE/5ML
PROCHLORPERAZINE MALEATE

CAPSULE, EXTENDED RELEASE;ORAL

COMPAZINE

GLAXOSMITHKLINE
EQ
EQ
EQ
EQ
EQ
EQ
TABLET;ORAL

COMPAZINE

GLAXOSMITHKLINE
EQ
EQ
EQ
PROCHLORPERAZINE

WATSON LABS
EQ
EQ
EQ
PROCHLORPERAZINE MALEATE

DURAMED PHARMS BARR
EQ
EQ
EQ
EQ
EQ
IVAX SUB TEVA PHARMS
EQ
EQ
SANDOZ
EQ

10MG
10MG
15MG
15MG
30MG
75MG

BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001
001
001

May
Apr
Dec
Dec
May
Jul
Jul
Jul

03,
07,
05,
04,
30,
08,
08,
08,

1988

1988

1988

1986

2003

1987

1987

1987

N011188 001

A087154 001 Sep 01, 1982

A088597 001 Oct 25, 1984

N011000
N021019
N011000
N021019
N011000
N011000

001

001 Oct 06, 1999

002

002 Oct 06, 1999

003

004

5MG BASE
10MG BASE
25MG BASE

N010571 001

N010571 002

N010571 003

5MG BASE
10MG BASE
25MG BASE

A085580 001

A085178 001

A085579 001

5MG BASE
5MG BASE
10MG BASE
10MG BASE
25MG BASE
5MG BASE
10MG BASE
25MG BASE

A040207
A089484
A040207
A089485
A089486
A040162
A040162
A040101

001
001
002
001
001
001
002
003

May
Jan
May
Jan
Jan
Jan
Jan
Jul

01,
20,
01,
20,
20,
20,
20,
19,

1997

1987

1997

1987

1987

1998

1998

1996

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6-285(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROCYCLIDINE HYDROCHLORIDE

TABLET;ORAL

KEMADRIN

MONARCH PHARMS
PROGESTERONE

CAPSULE;ORAL

PROMETRIUM

ABBVIE INC
INJECTABLE;INJECTION

PROGESTERONE

LILLY

2MG

5MG

N009818 005

N009818 003

300MG

N019781 003 Oct 15, 1999

25MG/ML

50MG/ML

INSERT, EXTENDED RELEASE;INTRAUTERINE

PROGESTASERT

ALZA

38MG

PROMAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

SPARINE

WYETH AYERST

INJECTABLE;INJECTION

PROMAZINE HYDROCHLORIDE

WATSON LABS

SPARINE

BAXTER HLTHCARE CORP

SYRUP;ORAL

SPARINE

WYETH AYERST

TABLET;ORAL

SPARINE

WYETH AYERST

PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

PHENERGAN

WYETH AYERST

N009238 002

N009238 001

N017553 001

30MG/ML

100MG/ML

N010942 001

N010942 004

25MG/ML

50MG/ML

A084510 001

A084517 001

25MG/ML

50MG/ML

N010349 008

N010349 006

10MG/5ML

N010942 003

10MG

25MG

50MG

100MG

200MG

N010348
N010348
N010348
N010348
N010348

25MG/ML

50MG/ML

N008857 002

N008857 003

PROMETHAZINE HYDROCHLORIDE

ABBOTT

25MG/ML

50MG/ML

AKORN

25MG/ML

50MG/ML

BEDFORD LABS

25MG/ML

50MG/ML

HOSPIRA

25MG/ML

50MG/ML

50MG/ML

LUITPOLD

25MG/ML

MARSAM PHARMS LLC

25MG/ML

50MG/ML

MYLAN INSTITUTIONAL

25MG/ML

SANDOZ

25MG/ML

50MG/ML

TEVA PHARMS USA

25MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

50MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

WATSON LABS

25MG/ML

25MG/ML

50MG/ML

50MG/ML

WOCKHARDT

25MG/ML

A084223
A084222
A083955
A083955
A040524
A040524
A040372
A040372
A083838
A040515
A089463
A089477
A040471
A040593
A040593
A040454

006

001

002

003

004

001

001

002

001

001
002
001
002
002

001
001
001
001
001
002
001

Mar
Mar
Jun
Jun

17,
17,
08,
08,

2004

2004

2000

2000

Mar
May
May
Nov
Nov
Nov
Aug

19,
02,
02,
21,
08,
08,
22,

2003

1988

1988

2002

2006

2006

2002

A040454 002 Aug 22, 2002

A083532
A084591
A080629
A083532
A040785

001

001

002

002

001 Sep 26, 2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-286(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

PROMETHAZINE HYDROCHLORIDE

ZIPAN-25

ALTANA
ZIPAN-50

ALTANA
SUPPOSITORY;RECTAL

PHENERGAN

DELCOR ASSET CORP

PROMETHACON

POLYMEDICA

50MG/ML

A040785 002 Sep 26, 2008

25MG/ML

A083997 001

50MG/ML

A083997 002

12.5MG
25MG
50MG

N010926 002

N010926 001

N011689 001

25MG
50MG

A084901 001

A084902 001

PROMETHAZINE HYDROCHLORIDE

ABLE
12.5MG
25MG
50MG
SYRUP;ORAL

MYMETHAZINE FORTIS

USL PHARMA
25MG/5ML
PROMETH FORTIS

ALPHARMA US PHARMS
25MG/5ML
PROMETH PLAIN

ACTAVIS MID ATLANTIC
6.25MG/5ML
PROMETHAZINE

CENCI
6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE

KV PHARM
6.25MG/5ML
25MG/5ML
PHARM ASSOC
6.25MG/5ML
WHITEWORTH TOWN PLSN
6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE PLAIN

ANI PHARMS
6.25MG/5ML
25MG/5ML **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

TABLET;ORAL

PHENERGAN

DELCOR ASSET CORP
12.5MG
25MG
50MG
PROMETHAZINE HYDROCHLORIDE

ABBOTT
12.5MG
25MG
50MG
ABLE
12.5MG
25MG
50MG
IMPAX LABS
25MG
IVAX SUB TEVA PHARMS 12.5MG
25MG
50MG
LANNETT
12.5MG
25MG
50MG
MUTUAL PHARM
12.5MG
25MG
50MG
PVT FORM
12.5MG
25MG
SANDOZ
12.5MG
12.5MG
25MG
50MG
TABLICAPS
12.5MG
25MG
TEVA
25MG
WATSON LABS
12.5MG
12.5MG

A040504 001 Apr 11, 2003

A040504 002 Apr 11, 2003

A040449 001 Feb 27, 2003

A087996 001 Jan 18, 1983

A084772 001

A085953 001

A089013 001 Sep 20, 1985

A085388
A085385
A087518
A086395

001

001

001

001

N008381 004 Apr 18, 1984

N008381 003

N007935 002

N007935 003

N007935 004

A084160
A084166
A084539
A040558
A040558
A040558
A084214
A083604
A083603
A083613
A080949
A080949
A080949
A084555
A084554
A084557
A083214
A083658
A084176
A084233
A085146
A085146
A084080
A084027
A089109
A083401
A083712

001

001

001

001
002
003
002
001

001

001

001

002

003

001

001

001

001

001

002
001

001

002

001

001

001
001

001

Jul
Jul
Jul
Jul

01,
01,
01,
07,

2004

2004

2004

1982

May 22, 2009

Sep 10, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-287(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROMETHAZINE HYDROCHLORIDE

TABLET;ORAL

PROMETHAZINE HYDROCHLORIDE

REMSED

BRISTOL MYERS SQUIBB
PROPAFENONE HYDROCHLORIDE

TABLET;ORAL

PROPAFENONE HYDROCHLORIDE

NESHER PHARMS

PROPANTHELINE BROMIDE

INJECTABLE;INJECTION

PRO-BANTHINE

GD SEARLE LLC
TABLET;ORAL

PRO-BANTHINE

SHIRE

PROPANTHELINE BROMIDE

ASCOT
HEATHER
IMPAX LABS
MYLAN
PAR PHARM
PVT FORM
ROXANE
SANDOZ
TABLICAPS
WATSON LABS
PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

KAINAIR

PHARMAFAIR
OPHTHAINE

APOTHECON

OPHTHETIC

ALLERGAN

12.5MG
25MG
25MG
50MG
50MG

A085986
A083204
A085684
A083403
A085664

25MG
50MG

A083176 002

A083176 001

150MG
225MG
300MG

A076193 001 Feb 07, 2002

A076193 002 Feb 07, 2002

A076193 003 Feb 07, 2002

30MG/VIAL

N008843 001

7.5MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

15MG

N008732 003

N008732 002

15MG
15MG
15MG
15MG
15MG
15MG
7.5MG
15MG
15MG
15MG
15MG

A087663
A085780
A084541
A083706
A088377
A080977
A080927
A080928
A084428
A083029
A083151

0.5%

A088087 001 Jun 07, 1983

0.5% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N008883 001

0.5% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N012583 001

PARACAINE

OPTOPICS
0.5%
PROPARACAINE HYDROCHLORIDE

SOLA BARNES HIND
0.5%
0.5%

001

001

001

001

001

001 Oct 25, 1982

001

002

001

001 Dec 08, 1983

001

001

001

001

002

001

A087681 001 Aug 05, 1982

A084144 001

A084151 001

PROPIOLACTONE

SOLUTION;IRRIGATION

BETAPRONE

FOREST LABS

N/A

N011657 001

PROPIOMAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

LARGON

HIKMA MAPLE

20MG/ML

N012382 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-288(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROPOFOL

INJECTABLE;INJECTION

DIPRIVAN

FRESENIUS KABI USA

PROPOFOL

EUROHLTH INTL SARL

TEVA PARENTERAL

PROPOXYPHENE HYDROCHLORIDE

CAPSULE;ORAL

DARVON

XANODYNE PHARM

DOLENE

HERITAGE PHARMS INC

KESSO-GESIC

MK LABS

PROPHENE 65

HALSEY

PROPOXYPHENE HYDROCHLORIDE

ALRA

IMPAX LABS

IVAX SUB TEVA PHARMS

MUTUAL PHARM

MYLAN

10MG/ML

N019627 001 Oct 02, 1989

10MG/ML

10MG/ML

A074848 001 Apr 19, 2005

A075392 001 Sep 19, 2000

32MG

65MG

N010997 001

N010997 003

65MG

A080530 001

65MG

A083544 001

65MG

A083538 002

65MG

65MG

32MG

65MG

32MG

65MG

65MG

NEXGEN PHARMA INC

65MG

PAR PHARM

65MG

PUREPAC PHARM

65MG

PVT FORM

32MG

65MG

ROXANE

32MG

65MG

SANDOZ

32MG

65MG

65MG

65MG

65MG

TEVA

65MG

VALEANT PHARM INTL

65MG

VINTAGE PHARMS

65MG

WATSON LABS

65MG

65MG

WEST WARD

65MG

WHITEWORTH TOWN PLSN
65MG

PROPOXYPHENE HYDROCHLORIDE 65

WARNER CHILCOTT
65MG

PROPOXYPHENE NAPSYLATE

SUSPENSION;ORAL

DARVON-N

AAIPHARMA LLC
TABLET;ORAL

DARVON-N

XANODYNE PHARM

A083184
A083317
A083597
A083186
A083528
A040569
A083299
A083185
A080269
A083278
A083464
A083113
A083089
A083089
A084014
A083125
A083688
A083870
A086495
A088615
A080783
A040908
A080908
A085190
A083501
A084551

001

001

001

001

001

001 Dec 16, 2004

001

001

001

001

001

001

001

002

001

002

001

002

001

001 Oct 22, 1984

001

001 Jul 17, 2009

002

001

001

001

A083786 001

50MG/5ML

N016861 001

100MG

N016862 002

PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PROPRANOLOL HYDROCHLORIDE

INWOOD LABS
60MG

80MG

120MG

160MG

CONCENTRATE;ORAL

PROPRANOLOL HYDROCHLORIDE INTENSOL

ROXANE

80MG/ML

INJECTABLE;INJECTION

PROPRANOLOL HYDROCHLORIDE

SMITH AND NEPHEW

1MG/ML

1MG/ML

SOLOPAK

1MG/ML

A072499
A072500
A072501
A072502

001
001
001
001

Apr
Apr
Apr
Apr

11,
11,
11,
11,

1989

1989

1989

1989

A071388 001 May 15, 1987

A070135 001 Apr 15, 1986

A070137 001 Apr 15, 1986

A070136 001 Apr 15, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-289(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROPRANOLOL HYDROCHLORIDE

SOLUTION;ORAL

PROPRANOLOL HYDROCHLORIDE

MORTON GROVE
SUSPENSION;ORAL

INDERAL

WYETH AYERST
TABLET;ORAL

INDERAL

WYETH PHARMS INC

PROPRANOLOL HYDROCHLORIDE

ANI PHARMS INC
DAVA PHARMS INC

DURAMED PHARMS BARR

INTERPHARM

IVAX SUB TEVA PHARMS

LEDERLE

MUTUAL PHARM

MYLAN
PAR PHARM
PUREPAC PHARM

ROXANE

SANDOZ

20MG/5ML
40MG/5ML

A071984 001 Mar 03, 1989

A071985 001 Mar 03, 1989

10MG/ML

N019536 001 Dec 12, 1986

10MG
20MG
40MG
60MG
80MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

90MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N016418
N016418
N016418
N016418
N016418

90MG
10MG
20MG
40MG
60MG
80MG
90MG
10MG
20MG
40MG
60MG
80MG
90MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
60MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
60MG
80MG
60MG
90MG
10MG
20MG
40MG
60MG
80MG
10MG
20MG
40MG
60MG
80MG
90MG
10MG
10MG
20MG
20MG
40MG
40MG

A071977
A070125
A070126
A070127
A071495
A070128
A071496
A070306
A070307
A070308
A070309
A070310
A071327
A071368
A071369
A071370
A071371
A072063
A072066
A072067
A072068
A072069
A072117
A072118
A072119
A072120
A070319
A070320
A070103
A070321
A070322
A072275
A071288
A070814
A070815
A070816
A070817
A070757
A070516
A070517
A070518
A070519
A070520
A070521
A070663
A071658
A070664
A071687
A070665
A071688

001

003

002

009 Oct 18, 1982

004

N016418 010 Oct 18, 1982

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Apr
Jul
Jul
Jul
Dec
Jul
Dec
Sep
Sep
Sep
Oct
Sep
Oct
May
May
May
May
Jul
Jul
Jul
Jul
Jul
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Sep
Aug
Jun
Oct
Nov
Nov
Nov
Nov
Nov
Jul
Jul
Jul
Sep
Jul
Sep
Jun
Jul
Jun
Jul
Jun
Jul

06,
30,
30,
30,
31,
30,
31,
09,
09,
09,
01,
09,
01,
05,
05,
05,
05,
29,
29,
29,
29,
29,
23,
23,
23,
23,
22,
22,
22,
24,
04,
09,
22,
03,
03,
03,
03,
03,
07,
07,
07,
24,
07,
24,
13,
05,
13,
05,
13,
05,

1988

1985

1985

1985

1987

1985

1987

1985

1985

1985

1986

1985

1986

1987

1987

1987

1987

1988

1988

1988

1988

1988

1988

1988

1988

1988

1985

1985

1985

1986

1986

1989

1986

1986

1986

1986

1986

1986

1986

1986

1986

1986

1986

1986

1986

1988

1986

1988

1986

1988

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-290(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL

PROPRANOLOL HYDROCHLORIDE

SCHERING

SUPERPHARM

TEVA

WARNER CHILCOTT

WATSON LABS

PROPYLIODONE

SUSPENSION;INTRATRACHEAL

DIONOSIL AQUEOUS

GLAXOSMITHKLINE
DIONOSIL OILY

GLAXOSMITHKLINE
PROPYLTHIOURACIL

TABLET;ORAL

PROPYLTHIOURACIL

ABBOTT
ANABOLIC
ANI PHARMS INC
HALSEY
HIKMA PHARMS LLC
IMPAX LABS
LANNETT
LILLY
MUTUAL PHARM
PERRIGO
TABLICAPS
WATSON LABS

60MG

60MG

80MG

80MG

90MG

10MG

20MG

40MG

60MG

80MG

10MG

20MG

40MG

80MG

10MG

20MG

40MG

10MG

20MG

40MG

60MG

80MG

10MG

10MG

10MG

20MG

20MG

20MG

40MG

40MG

40MG

60MG

60MG

60MG

60MG

80MG

80MG

80MG

90MG

90MG

A070666
A072197
A070667
A071689
A072198
A070120
A070121
A070122
A070123
A070124
A071515
A071516
A071517
A071518
A070232
A070233
A070234
A070438
A070439
A070440
A070441
A070442
A070140
A070378
A070548
A070141
A070379
A070549
A070142
A070380
A070550
A070143
A070381
A071098
A071791
A070144
A070382
A070551
A071183
A071792

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

50%

N009309 001

60%

N009309 002

50MG

50MG

50MG

50MG

50MG

50MG

50MG

50MG

50MG

50MG

50MG

50MG

50MG

A084075
A080285
A080215
A080015
A080154
A080159
A080016
N006213
A083982
A084543
A080840
A080932
A085201

001

001

001

001

001

001

001

001

001

001

001

001

001

Oct
Jul
Jun
Jul
Jul
Aug
Aug
Aug
Oct
Aug
Jun
Jun
Jun
Jun
Oct
Jun
Jun
Sep
Sep
Sep
Sep
Sep
Jul
Mar
Jul
Jul
Mar
Apr
Jul
Mar
Apr
Jan
Mar
Oct
Jul
Jul
Mar
Jul
Oct
Jul

10,
05,
13,
05,
05,
06,
06,
06,
29,
06,
08,
08,
08,
08,
07,
23,
23,
15,
15,
15,
24,
15,
30,
19,
10,
30,
19,
11,
30,
19,
11,
15,
19,
06,
15,
30,
19,
10,
06,
15,

1986

1988

1986

1988

1988

1985

1985

1985

1986

1985

1988

1988

1988

1988

1987

1986

1986

1986

1986

1986

1986

1986

1985

1987

1986

1985

1987

1986

1985

1987

1986

1987

1987

1986

1987

1985

1987

1986

1986

1987

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-291(of 347)

DISCONTINUED DRUG PRODUCT LIST

PROTAMINE SULFATE

INJECTABLE;INJECTION

PROTAMINE SULFATE

HIKMA MAPLE
LILLY
PHARMACIA AND UPJOHN
PROTEIN HYDROLYSATE

INJECTABLE;INJECTION

AMINOSOL 5%

ABBVIE
HYPROTIGEN 5%

B BRAUN
PROTIRELIN

INJECTABLE;INJECTION

THYPINONE

ABBOTT
THYREL TRH

FERRING
PROTOKYLOL HYDROCHLORIDE

TABLET;ORAL

VENTAIRE

SANOFI AVENTIS US
PROTRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

VIVACTIL

TEVA WOMENS

10MG/ML
10MG/ML
10MG/ML
50MG/VIAL
250MG/VIAL

A089474
A089475
N006460
N007413
N007413

5%

N005932 012 Jan 31, 1985

5%

N006170 003 Jan 10, 1984

0.5MG/ML

N017638 001

0.5MG/ML

N018087 001

2MG

A083459 001

5MG
10MG

N016012 001

N016012 002

PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

NOVAFED

SANOFI AVENTIS US
120MG
SUDAFED 12 HOUR

GLAXOSMITHKLINE
120MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

ACTIFED

GLAXOSMITHKLINE
120MG;5MG
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES

KV PHARM
120MG;5MG
SYRUP;ORAL

ACTAHIST

CENCI
30MG/5ML;1.25MG/5ML
HISTAFED

CENCI
30MG/5ML;1.25MG/5ML
MYFED

USL PHARMA
30MG/5ML;1.25MG/5ML
TRILITRON

NEWTRON PHARMS
30MG/5ML;1.25MG/5ML
TABLET;ORAL

ALLERFED

PVT FORM
60MG;2.5MG
CORPHED

SANDOZ
60MG;2.5MG
PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE

SANDOZ
60MG;2.5MG
TRILITRON

NEWTRON PHARMS
60MG;2.5MG
TRIPHED

TEVA
60MG;2.5MG
TRIPROLIDINE AND PSEUDOEPHEDRINE

WATSON LABS
60MG;2.5MG
WEST WARD
60MG;2.5MG
TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

IVAX SUB TEVA PHARMS
60MG;2.5MG
SUPERPHARM
60MG;2.5MG

001 Nov 05, 1986

001 Nov 05, 1986

002

001

002 Aug 02, 1984

N017603 001

N017941 002

N018996 001 Jun 17, 1985

A071798 001 Mar 16, 1989

A088344 001 Feb 09, 1984

A088283 001 Apr 20, 1984

A088116 001 Mar 04, 1983

A088474 001 Feb 12, 1985

A088860 001 Jan 31, 1985

A088602 001 Apr 11, 1985

A088193 001 May 17, 1983

A088515 001 Jan 09, 1985

A088630 001 May 17, 1984

A088318 002 Jan 13, 1984

A088117 001 Apr 19, 1983

A085273 001 Dec 12, 1984

A088578 001 Feb 21, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-292(of 347)

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PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES

KV PHARM
120MG;5MG

A072758 001 Nov 25, 1991

PSEUDOEPHEDRINE POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

PSEUDO-12

UCB INC

EQ 60MG HCL/5ML

N019401 001 Jun 19, 1987

PYRIDOSTIGMINE BROMIDE

TABLET;ORAL

PYRIDOSTIGMINE BROMIDE

ANI PHARMS INC

30MG

60MG

60MG

30MG

30MG

A040512
A040512
A040457
A089572
N020414

100MG/ML

A080854 001

100MG/ML

100MG/ML

50MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

A087967
A080761
A083771
A083772
A080581
A080669
A080572
A083760

PYRILAMINE MALEATE

TABLET;ORAL

PYRILAMINE MALEATE

IMPAX LABS

WATSON LABS

25MG

25MG

A080808 001

A085231 001

PYRIMETHAMINE; SULFADOXINE

TABLET;ORAL

FANSIDAR

ROCHE

25MG;500MG

N018557 001

COREPHARMA

SOLVAY

US ARMY

PYRIDOXINE HYDROCHLORIDE

INJECTABLE;INJECTION

HEXA-BETALIN

LILLY

PYRIDOXINE HYDROCHLORIDE

AKORN

BEL MAR

DELL LABS

ELKINS SINN

LUITPOLD

WATSON LABS

PYRITHIONE ZINC

LOTION;TOPICAL

HEAD & SHOULDERS CONDITIONER

WARNER CHILCOTT

0.3%

PYRVINIUM PAMOATE

SUSPENSION;ORAL

POVAN

PARKE DAVIS

TABLET;ORAL

POVAN

PARKE DAVIS

QUAZEPAM

TABLET;ORAL

DORAL

SCIECURE PHARMA INC

QUETIAPINE FUMARATE

TABLET;ORAL

SEROQUEL

ASTRAZENECA PHARMS

QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

QUINAPRIL HYDROCHLORIDE

ACTAVIS ELIZABETH

APOTEX INC

002
001
001
001
001

Jul
Oct
Dec
Nov
Feb

20,
08,
26,
27,
05,

2005

2003

2002

1990

2003

001 Oct 01, 1982

001

001

001

001

001

001

001

N019412 002 Mar 10, 1986

EQ 50MG BASE/5ML

N011964 001

EQ 50MG BASE

N012485 002

7.5MG

15MG

N018708 003 Feb 26, 1987

N018708 001 Dec 27, 1985

EQ 150MG BASE

N020639 004 Dec 20, 1998

EQ
EQ
EQ
EQ
EQ
EQ

A076459
A076459
A076459
A076459
A076240
A076240

5MG BASE

10MG BASE

20MG BASE

40MG BASE

5MG BASE

10MG BASE

001
002
003
004
001
002

Dec
Dec
Dec
Dec
Jan
Jan

22,
22,
22,
22,
26,
26,

2004

2004

2004

2004

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-293(of 347)

DISCONTINUED DRUG PRODUCT LIST

QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

QUINAPRIL HYDROCHLORIDE

MYLAN

SANDOZ

QUINESTROL

TABLET;ORAL

ESTROVIS

PARKE DAVIS

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

20MG BASE

40MG BASE

5MG BASE

10MG BASE

20MG BASE

40MG BASE

5MG BASE

10MG BASE

20MG BASE

40MG BASE

A076240
A076240
A076036
A076036
A076036
A076036
A076803
A076803
A076803
A076803

003
004
001
002
003
004
001
002
003
004

0.1MG

0.2MG

N016768 002

N016768 003

QUINETHAZONE

TABLET;ORAL

HYDROMOX

LEDERLE

50MG

N013264 001

QUINETHAZONE; RESERPINE

TABLET;ORAL

HYDROMOX R

LEDERLE

50MG;0.125MG

N013927 001

QUINIDINE GLUCONATE

TABLET;ORAL

QUINACT

BAYER HLTHCARE

266MG

400MG

TABLET, EXTENDED RELEASE;ORAL

DURAQUIN

WARNER CHILCOTT

330MG

QUINAGLUTE

BAYER HLTHCARE

324MG

QUINALAN

LANNETT

324MG

QUINATIME

WATSON LABS

324MG

QUINIDINE GLUCONATE

ASCOT

324MG

CYCLE PHARMS LTD

324MG

HALSEY

324MG

SANDOZ

324MG

SUPERPHARM

324MG

WATSON LABS

324MG

324MG

QUINIDINE POLYGALACTURONATE

TABLET;ORAL

CARDIOQUIN

PHARM RES ASSOC

QUINIDINE SULFATE

CAPSULE;ORAL

CIN-QUIN

SOLVAY

QUINIDINE SULFATE

LILLY

TABLET;ORAL

CIN-QUIN

SOLVAY

QUINIDINE SULFATE

BARR

CONTRACT PHARMACAL

CYCLE PHARMS LTD

Jan
Jan
Jan
Jan
Jan
Jan
Mar
Mar
Mar
Mar

26,
26,
28,
28,
28,
28,
02,
02,
02,
02,

2006

2006

2005

2005

2005

2005

2005

2005

2005

2005

A085978 001

A086099 001

N017917 001

N016647 001

A088081 001 Feb 10, 1986

A087448 001

A088582
A088431
A089476
A089894
A089164
A087785
A087810

001
001
001
001
001
001
001

275MG

N011642 002

200MG

300MG

A085296 001

A085297 001

200MG

A085103 001

100MG

200MG

300MG

A085299 001

A084932 001

A085298 001

200MG

200MG

200MG

300MG

A084177
A083808
A083640
A085632

001

001

001

001

Jun
Jan
Apr
Dec
Nov
Jan
Sep

17,
06,
10,
15,
21,
24,
29,

1985

1984

1987

1988

1985

1983

1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-294(of 347)

DISCONTINUED DRUG PRODUCT LIST

QUINIDINE SULFATE

TABLET;ORAL

QUINIDINE SULFATE

DAVA PHARMS INC

ELKINS SINN

EVERYLIFE

HALSEY

HIKMA PHARMS LLC

IMPAX LABS

IVAX SUB TEVA PHARMS

KING PHARMS

KV PHARM

LANNETT

LEDERLE

LILLY

MUTUAL PHARM

PERRIGO

PHARMAVITE

PUREPAC PHARM

SANDOZ

SCHERER LABS

SUPERPHARM

USL PHARMA

VALEANT PHARM INTL

VANGARD

VINTAGE PHARMS

WARNER CHILCOTT

WATSON LABS

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

100MG

200MG

200MG

200MG

200MG

200MG

300MG

200MG

200MG

200MG

200MG

200MG

200MG

200MG

100MG

200MG

200MG

WHITEWORTH TOWN PLSN

QUINORA

KEY PHARMS

200MG

SCHERING

300MG

TABLET, EXTENDED RELEASE;ORAL

QUINIDEX

WYETH PHARMS INC

300MG

RABEPRAZOLE SODIUM

TABLET, DELAYED RELEASE;ORAL

ACIPHEX

EISAI INC

10MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

RAMIPRIL

CAPSULE;ORAL

RAMIPRIL

ACTAVIS ELIZABETH

CIPLA

RANBAXY LABS LTD

TABLET;ORAL

ALTACE

KING PFIZER

RAMIPRIL

MYLAN PHARMS INC

ZYDUS PHARMS USA INC

A087011
A083622
A083439
A083583
A083862
A083347
A084549
A085175
A085276
A083743
A086176
A085038
A081029
A085322
A084627
A084003
A084631
A084914
A089839
A085068
A088973
A087837
A083393
A087909
A083963
A083879
A085584
A085140
A085444

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

002

001

Apr 14, 1989

Sep 29, 1988

Apr 10, 1985

Apr 14, 1982

Jul 13, 1982

A083576 001

A085222 001

N012796 002

N020973 001
May 29, 2002

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

10MG

5MG

10MG

A077513
A077513
A077513
A077513
A077004
A077004
A077004
A077004
A078849
A078849

001

002

003

004

001

002

003

004

001

002

Jun
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Mar
Mar

18,
18,
18,
18,
07,
07,
07,
07,
06,
06,

2008

2008

2008

2008

2008

2008

2008

2008

2009

2009

1.25MG

2.5MG

5MG

10MG

N022021
N022021
N022021
N022021

001

002

003

004

Feb
Feb
Feb
Feb

27,
27,
27,
27,

2007

2007

2007

2007

1.25MG

2.5MG

5MG

10MG

1.25MG

2.5MG

5MG

A090650
A090650
A090650
A090650
A090697
A090697
A090697

001

002

003

004

001

002

003

Jun
Jun
Jun
Jun
Sep
Sep
Sep

30,
30,
30,
30,
24,
24,
24,

2011

2011

2011

2011

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-295(of 347)

DISCONTINUED DRUG PRODUCT LIST

RAMIPRIL

TABLET;ORAL

RAMIPRIL

RANITIDINE BISMUTH CITRATE

TABLET;ORAL

TRITEC

GLAXOSMITHKLINE
RANITIDINE HYDROCHLORIDE

CAPSULE;ORAL

RANITIDINE HYDROCHLORIDE

MYLAN
TEVA

10MG

A090697 004 Sep 24, 2009

400MG

N020559 001 Aug 08, 1996

EQ
EQ
EQ
EQ

150MG
300MG
150MG
300MG

BASE
BASE
BASE
BASE

ZANTAC 150

GLAXOSMITHKLINE
EQ 150MG BASE
ZANTAC 300

GLAXOSMITHKLINE
EQ 300MG BASE
GRANULE, EFFERVESCENT;ORAL

ZANTAC 150

GLAXO GRP LTD
EQ 150MG BASE/PACKET
INJECTABLE;INJECTION

RANITIDINE HYDROCHLORIDE

BEDFORD
EQ 25MG BASE/ML
ZANTAC IN PLASTIC CONTAINER

COVIS INJECTABLES
EQ 1MG BASE/ML
EQ 50MG BASE/100ML
SYRUP;ORAL

RANITIDINE HYDROCHLORIDE

APOTEX INC
EQ 15MG BASE/ML
RANBAXY
EQ 15MG BASE/ML
TABLET;ORAL

RANITIDINE HYDROCHLORIDE

BOEHRINGER INGELHEIM
EQ 150MG BASE
EQ 300MG BASE
MYLAN
EQ 150MG BASE
EQ 300MG BASE
RANBAXY
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
SANDOZ
EQ 75MG BASE
SUN PHARM INDS LTD
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
WATSON LABS
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
WATSON LABS INC
EQ 150MG BASE
EQ 300MG BASE
WOCKHARDT
EQ 75MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 300MG BASE
TABLET, EFFERVESCENT;ORAL

ZANTAC 150

GLAXO GRP LTD
EQ 150MG BASE
ZANTAC 25

GLAXO GRP LTD
EQ 25MG BASE
ZANTAC 75

BOEHRINGER INGELHEIM
EQ 75MG BASE **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

RAPACURONIUM BROMIDE

INJECTABLE;INJECTION

RAPLON

ORGANON USA INC

100MG/VIAL
200MG/VIAL

A075564
A075564
A075557
A075557

001
002
001
002

Oct
Oct
Oct
Oct

27,
27,
31,
31,

2000

2000

2003

2003

N020095 001 Mar 08, 1994

N020095 002 Mar 08, 1994

N020251 002 Mar 31, 1994

A074764 001 Nov 19, 2004

N019593 002 Sep 27, 1991

N019593 001 Dec 17, 1986

A077602 001 Sep 17, 2007

A078448 001 Dec 13, 2007

A074662
A074662
A074552
A074552
A075254
A075000
A075000
A075519
A075132
A075439
A075439
A075212
A074864
A074864
A077426
A077426
A078884
A078653
A078701
A078701

001
002
001
002
001
001
002
001
001
001
002
001
001
002
001
002
001
001
001
002

Aug
Aug
Jul
Jul
Jan
Jan
Jan
Sep
Jan
Apr
Apr
Jan
Oct
Oct
Dec
Dec
Jul
Nov
Nov
Dec

29,
29,
30,
30,
14,
30,
30,
26,
14,
19,
19,
14,
20,
20,
19,
19,
31,
26,
12,
11,

1997

1997

1998

1998

2000

1998

1998

2002

2000

2000

2000

2000

1997

1997

2005

2005

2008

2007

2009

2009

N020251 001 Mar 31, 1994

N020251 003 Apr 01, 2004

N020745 001 Feb 26, 1998

N020984 001 Aug 18, 1999

N020984 002 Aug 18, 1999

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-296(of 347)

DISCONTINUED DRUG PRODUCT LIST

RASAGILINE MESYLATE

TABLET;ORAL

RASAGILINE MESYLATE

WATSON LABS INC
RAUWOLFIA SERPENTINA ROOT

TABLET;ORAL

HIWOLFIA

BOWMAN PHARMS

HYSERPIN

PHYS PRODS VA
KOGLUCOID

PANRAY
RAUDIXIN

APOTHECON
RAUSERPIN

FERNDALE LABS
RAUVAL

PAL PAK
RAUWOLFIA SERPENTINA

BUNDY
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
PUREPAC PHARM
PVT FORM
SOLVAY
TABLICAPS
VALEANT PHARM INTL
WATSON LABS
WOLFINA

FOREST PHARMS
RESCINNAMINE

CAPSULE;ORAL

CINNASIL

PANRAY
TABLET;ORAL

MODERIL

PFIZER
RESERPINE

ELIXIR;ORAL

SERPASIL

NOVARTIS
INJECTABLE;INJECTION

SANDRIL

LILLY
SERPASIL

NOVARTIS
TABLET;ORAL

HISERPIA

BOWMAN PHARMS

EQ 0.5MG BASE

EQ 1MG BASE

A201823 001 Jul 01, 2013

A201823 002 Jul 01, 2013

50MG

50MG

100MG

N009276 003

N009276 005

N009276 004

50MG

N010581 001

50MG

100MG

N009278 001

N009278 002

50MG

100MG

N008842 001

N008842 002

50MG

100MG

N009926 002

N009926 004

50MG

100MG

N009108 002

N009108 004

50MG

100MG

50MG

100MG

50MG

100MG

50MG

100MG

50MG

100MG

50MG

100MG

50MG

100MG

50MG

100MG

50MG

100MG

50MG

100MG

N009477
N009477
A080498
A080498
N009273
N009273
N011521
N011521
A080842
A080842
A080583
A080583
A080500
A080500
A083867
A083444
N009668
N009668
A080907
A080914

50MG

100MG

N009255 008

N009255 006

0.5MG

A084736 001

0.25MG

0.5MG

N010686 003

N010686 006

0.2MG/4ML

N009115 005

2.5MG/ML

N010012 001

2.5MG/ML

N009434 002

0.1MG

0.25MG

N009631 002

N009631 004

001

002

001

002

001

002

001

002

001

002

001

002

001

002

001

001

001

002

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-297(of 347)

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RESERPINE

TABLET;ORAL

RAU-SED

BRISTOL MYERS SQUIBB

RESERPINE

BARR
BELL PHARMA
BUNDY
CYCLE PHARMS LTD
ELKINS SINN
EVERYLIFE

HALSEY

HIKMA PHARMS LLC

IMPAX LABS
IVAX SUB TEVA PHARMS
MARSHALL PHARMA
MK LABS
MYLAN
PHARMAVITE
PUREPAC PHARM
PVT FORM

REXALL
SOLVAY
TABLICAPS
TEVA
VALEANT PHARM INTL
WATSON LABS

WHITEWORTH TOWN PLSN

SANDRIL

LILLY
SERPALAN

LANNETT
SERPANRAY

PANRAY

SERPASIL

NOVARTIS

0.1MG

0.25MG

0.5MG

1MG

N009357
N009357
N009357
N009357

001

004

006

008

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

0.5MG

1MG

0.1MG

0.25MG

1MG

0.1MG

0.25MG

1MG

0.1MG

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

1MG

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

0.25MG

1MG

0.25MG

0.25MG

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

0.1MG

0.25MG

0.25MG

1MG

0.1MG

0.25MG

1MG

A080721
A083058
A083058
N009663
N009663
N009859
N009859
A083145
A083145
N010441
N010441
N010441
N010441
A080457
A080457
A080457
A080975
A080975
A080975
N009627
N009627
N011185
N011185
A080492
A080492
A080525
A080525
A084974
A084663
A080753
A080753
A086117
A080582
A085775
A080582
A080637
A080446
A085207
A089020
A089019
N009667
N009667
A080679
A080393
A085401
A080749
A080723
A080723
A080723

002

001

002

001

003

001

002

001

002

001

002

003

004

002

001

003

001

002

003

001

002

001

002

001

002

002

001

001

001

002

001

001

001

001

002

001

001

001

001 Mar 07, 1985

001 Mar 07, 1985

001

002

001

001

001

001

001

002

003

0.1MG

0.25MG

N009376 004

N009376 001

0.1MG

0.25MG

N010124 001

N010124 002

0.1MG

0.25MG

1MG

N009391 001

N009391 002

N009391 004

0.1MG

0.25MG

1MG

N009115 001

N009115 003

N009115 004

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-298(of 347)

DISCONTINUED DRUG PRODUCT LIST

RESERPINE

TABLET;ORAL

SERPATE

VALE
SERPIVITE

VITARINE

0.1MG
0.25MG

N009453 001

N009453 002

0.25MG

N009645 002

RESERPINE; TRICHLORMETHIAZIDE

TABLET;ORAL

METATENSIN #2

SANOFI AVENTIS US
0.1MG;2MG
METATENSIN #4

SANOFI AVENTIS US
0.1MG;4MG
NAQUIVAL

SCHERING
0.1MG;4MG
TRICHLORMETHIAZIDE W/ RESERPINE

WATSON LABS
0.1MG;4MG
RIBAVIRIN
CAPSULE;ORAL
REBETOL
MERCK SHARP DOHME

TABLET;ORAL
COPEGUS
ROCHE
RIMANTADINE HYDROCHLORIDE
SYRUP;ORAL
FLUMADINE
FOREST LABS
TABLET;ORAL
RIMANTADINE HYDROCHLORIDE
ACTAVIS ELIZABETH
COREPHARMA
RISEDRONATE SODIUM
TABLET;ORAL
ACTONEL
WARNER CHILCOTT LLC

RISPERIDONE
TABLET;ORAL
RISPERDAL
JANSSEN PHARMS
RISPERIDONE
CADISTA PHARMS

RATIOPHARM

SYNTHON PHARMS

WATSON LABS

N012972 001

N012972 002

N012265 003

A085248 001

200MG**Indicated for use and comarketed

with Interferon ALFA-2B, Recombinant
(INTRON A), as Rebetron Combination
Therapy**

N020903 001 Jun 03, 1998

400MG

N021511 002 Jun 21, 2005

50MG/5ML

N019650 001 Sep 17, 1993

100MG
100MG

A076375 001 Jan 14, 2003

A075916 001 Nov 02, 2001

75MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N020835 004 Apr 16, 2007

5MG

N020272 005 Dec 29, 1993

0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG

A078828
A078828
A078828
A078828
A078828
A078828
A077784
A077784
A077784
A077784
A077784
A077784
A078187
A078187
A078187
A078187
A078187
A078187
A077860
A077860
A077860
A077860
A077860
A077860

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006

Mar
Mar
Mar
Mar
Mar
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Oct
Dec
Dec
Dec
Dec
Dec
Dec

23,
23,
23,
23,
23,
23,
08,
08,
08,
08,
08,
08,
22,
22,
22,
22,
22,
22,
05,
05,
05,
05,
05,
05,

2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2010
2010
2009
2009
2009
2009
2009
2009
2008
2008
2008
2008
2008
2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-299(of 347)

DISCONTINUED DRUG PRODUCT LIST

RISPERIDONE

TABLET;ORAL

RISPERIDONE

WEST WARD PHARMS

0.25MG
0.5MG
1MG
2MG
3MG
4MG

RITODRINE HYDROCHLORIDE

INJECTABLE;INJECTION

RITODRINE HYDROCHLORIDE

ABRAXIS PHARM

10MG/ML
15MG/ML
HOSPIRA
10MG/ML
15MG/ML
RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA
30MG/100ML
YUTOPAR

ASTRAZENECA
10MG/ML
15MG/ML
TABLET;ORAL

YUTOPAR

ASTRAZENECA
10MG

A078740
A078740
A078740
A078740
A078740
A078740

001
002
003
004
005
006

May
May
May
May
May
May

29,
29,
29,
29,
29,
29,

2009

2009

2009

2009

2009

2009

A071188
A071189
A071618
A071619

001
001
001
001

Jul
Jul
Feb
Feb

23,
23,
28,
28,

1987

1987

1991

1991

A071438 001 Jan 22, 1991

N018580 001

N018580 002

N018555 001

RITONAVIR

CAPSULE;ORAL

NORVIR

ABBOTT

100MG

N020680 001 Mar 01, 1996

RIVASTIGMINE TARTRATE

SOLUTION;ORAL

EXELON

NOVARTIS

EQ 2MG BASE/ML

N021025 001 Apr 21, 2000

50MG/5ML (10MG/ML) **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

10MG/ML (10MG/ML) **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

100MG/10ML (10MG/ML) **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N020214 001 Mar 17, 1994

ROCURONIUM BROMIDE

INJECTABLE;INJECTION

ZEMURON

ORGANON USA INC

ROFECOXIB

SUSPENSION;ORAL

VIOXX

MERCK
TABLET;ORAL

VIOXX

MERCK

ROPINIROLE HYDROCHLORIDE

TABLET;ORAL

ROPINIROLE HYDROCHLORIDE

COREPHARMA

N020214 002 Mar 17, 1994

N020214 003 Mar 17, 1994

12.5MG/5ML
25MG/5ML

N021052 001 May 20, 1999

N021052 002 May 20, 1999

12.5MG
25MG
50MG

N021042 001 May 20, 1999

N021042 002 May 20, 1999

N021042 003 Feb 25, 2000

EQ
EQ
EQ
EQ
EQ
EQ
EQ
TABLET, EXTENDED RELEASE;ORAL

REQUIP XL

GLAXOSMITHKLINE LLC
EQ

0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE

A078230
A078230
A078230
A078230
A078230
A078230
A078230

001
002
003
004
005
006
007

May
May
May
May
May
May
May

20,
20,
20,
20,
20,
20,
20,

2008

2008

2008

2008

2008

2008

2008

3MG BASE

N022008 002 Jun 13, 2008

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-300(of 347)

DISCONTINUED DRUG PRODUCT LIST

ROSE BENGAL SODIUM I-131

INJECTABLE;INJECTION

ROBENGATOPE

BRACCO

0.5mCi/VIAL
1mCi/VIAL
2mCi/VIAL

N016224 001

N016224 002

N016224 003

0.5mCi/ML

N017318 001

100MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N021911 001 Nov 14, 2008

10% (10GM/100ML)

N018203 001

20% (20GM/100ML)

N018614 001

5%;5% (5GM/100ML)

N018997 001 Aug 27, 1984

10%;10% (10GM/100ML)

N018991 001 Aug 27, 1984

SALMETEROL XINAFOATE

AEROSOL, METERED;INHALATION

SEREVENT

GLAXOSMITHKLINE

EQ 0.021MG BASE/INH

N020236 001 Feb 04, 1994

SAQUINAVIR

CAPSULE;ORAL

FORTOVASE

HOFFMANN LA ROCHE

200MG

N020828 001 Nov 07, 1997

SARALASIN ACETATE

INJECTABLE;INJECTION

SARENIN

PROCTER AND GAMBLE

EQ 0.6MG BASE/ML

N018009 001

100MG
100MG
100MG
100MG
100MG
100MG
50MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG

A084422
A084225
A085895
A084676
A085869
A085285
A085909
A085903
A084762
A084561
A085867
A085477
A085898
A086273
A085792
A084926
A085798
A086390

100MG/VIAL
50MG/ML

A083281 001

A083262 001

50MG/ML

N007392 002

30MG

A086530 001

SODIUM ROSE BENGAL I 131

SORIN
RUFINAMIDE

TABLET;ORAL

BANZEL

EISAI INC

SAFFLOWER OIL

INJECTABLE;INJECTION

LIPOSYN 10%

ABBOTT
LIPOSYN 20%

ABBOTT
SAFFLOWER OIL; SOYBEAN OIL

INJECTABLE;INJECTION

LIPOSYN II 10%

HOSPIRA
LIPOSYN II 20%

HOSPIRA

SECOBARBITAL SODIUM

CAPSULE;ORAL

SECOBARBITAL SODIUM

ANABOLIC
BARR
EVERYLIFE
HALSEY
IVAX PHARMS
KV PHARM
LANNETT
PARKE DAVIS
PERRIGO
PUREPAC PHARM
VALEANT PHARM INTL
VITARINE
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
WYETH AYERST
INJECTABLE;INJECTION

SECOBARBITAL SODIUM

ELKINS SINN
WYETH AYERST
SECONAL SODIUM

LILLY
SUPPOSITORY;RECTAL

SECONAL SODIUM

LILLY

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-301(of 347)

DISCONTINUED DRUG PRODUCT LIST

SECOBARBITAL SODIUM

SUPPOSITORY;RECTAL

SECONAL SODIUM

60MG

120MG

200MG

A086530 002

A086530 003

A086530 004

SECRETIN

INJECTABLE;INJECTION

SECRETIN-FERRING

FERRING

75CU/VIAL

N018290 001

SECRETIN SYNTHETIC PORCINE

FOR SOLUTION;INTRAVENOUS

SECREFLO

CHIRHOCLIN

16MCG/VIAL

N021136 001
Apr 04, 2002

5MG

A075145 001
Sep 15, 2003

5MG

5MG

5MG

5MG

5MG

5MG

5MG

A074641
A074537
A074744
A074756
A074672
N019334
A074565

2.5%

A083892 001

2.5%

2.5%

2.5%

A084394 001

A086209 001

A085777 001

250uCi/ML

100uCi/ML

500uCi/ML

N017257 001

N017098 001

N017322 001

85-550uCi/ML

N017047 001

40 UNITS/ML

80 UNITS/ML

N017861 001

N017861 002

EQ 0.05MG BASE/AMP **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 0.5MG BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 1MG BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N019863 001
Dec 28, 1990

EQ 20MG BASE/ML

EQ 20MG BASE/ML

A078053 001
Feb 05, 2007

A076934 001
Jun 30, 2006

SELEGILINE HYDROCHLORIDE

CAPSULE;ORAL

SELEGILINE HYDROCHLORIDE

LANNETT HOLDINGS INC

TABLET;ORAL

SELEGILINE HYDROCHLORIDE

DAVA PHARMS INC

G AND W LABS INC

SIEGFRIED

SOMERSET

VINTAGE PHARMS LLC

SELENIUM SULFIDE

LOTION/SHAMPOO;TOPICAL

EXSEL

ALLERGAN HERBERT

SELENIUM SULFIDE

ACTAVIS MID ATLANTIC

G AND W LABS INC

IVAX PHARMS

SELENOMETHIONINE SE-75

INJECTABLE;INJECTION

SELENOMETHIONINE SE 75

GE HEALTHCARE

MALLINCKRODT

PHARMALUCENCE

SETHOTOPE

BRACCO

SERACTIDE ACETATE

INJECTABLE;INJECTION

ACTHAR GEL-SYNTHETIC

ARMOUR PHARM

SERMORELIN ACETATE

INJECTABLE;INJECTION

GEREF

EMD SERONO

EMD SERONO INC

SERTRALINE HYDROCHLORIDE

CONCENTRATE;ORAL

SERTRALINE HYDROCHLORIDE

RANBAXY LABS LTD

ROXANE

001

001

001

001

001

001

001

Aug
Aug
Jan
Nov
Apr
Jun
Aug

02,
02,
27,
25,
01,
05,
02,

1996

1996

1997

1998

1997

1989

1996

N020443 001
Sep 26, 1997

N020443 002
Sep 26, 1997

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-302(of 347)

DISCONTINUED DRUG PRODUCT LIST

SERTRALINE HYDROCHLORIDE

TABLET;ORAL

SERTRALINE HYDROCHLORIDE

ACTAVIS ELIZABETH

CIPLA LTD

DR REDDYS LABS LTD

HIKMA PHARMS

IVAX SUB TEVA PHARMS

MUTUAL PHARM

MYLAN PHARMS INC

PLIVA HRVATSKA DOO

ROXANE

SANDOZ

WATSON LABS

ZOLOFT

PFIZER

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE

A077345
A077345
A077345
A077162
A077162
A077162
A076442
A076442
A076442
A077864
A077864
A077864
A075719
A075719
A075719
A077818
A077818
A077818
A076540
A076540
A076540
A077299
A077299
A077299
A076881
A076881
A076881
A077713
A077713
A077713
A077663
A077663
A077663

001
002
003
001
002
003
001
002
003
001
002
003
003
001
002
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Feb
Feb
Feb
Feb
Feb
Feb
Apr
Apr
Apr
Aug
Aug
Aug
Jun
Jun
Jun
Feb
Feb
Feb
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

06,
06,
06,
06,
06,
06,
30,
30,
30,
10,
10,
10,
30,
30,
30,
06,
06,
06,
20,
20,
20,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,

2007

2007

2007

2007

2007

2007

2007

2007

2007

2009

2009

2009

2006

2006

2006

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

EQ 150MG BASE
EQ 200MG BASE

N019839 003 Dec 30, 1991

N019839 004 Dec 30, 1991

403MG

N020926 001 Oct 30, 1998

5MG
10MG
15MG

N020632 001 Nov 22, 1997

N020632 002 Nov 22, 1997

N020632 003 Nov 22, 1997

SILVER SULFADIAZINE

DRESSING;TOPICAL

SILDAFLO

FRANKLIN PHARMS

1%

N019608 001 Nov 30, 1989

SIMETHICONE-CELLULOSE

SUSPENSION;ORAL

SONORX

BRACCO

7.5MG/ML

N020773 001 Oct 29, 1998

SEVELAMER HYDROCHLORIDE

CAPSULE;ORAL

RENAGEL

GENZYME
SIBUTRAMINE HYDROCHLORIDE

CAPSULE;ORAL

MERIDIA

ABBOTT

SIMVASTATIN

TABLET;ORAL

SIMVASTATIN

SANDOZ INC

5MG
10MG
20MG
40MG
80MG
TABLET, ORALLY DISINTEGRATING;ORAL

SIMVASTATIN

SYNTHON PHARMS
10MG
20MG
40MG

A077766
A077766
A077766
A077766
A077766

001
002
003
004
005

Dec
Dec
Dec
Dec
Dec

20,
20,
20,
20,
20,

2006

2006

2006

2006

2006

N021961 001 Oct 09, 2007

N021961 002 Oct 09, 2007

N021961 003 Oct 09, 2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-303(of 347)

DISCONTINUED DRUG PRODUCT LIST

SIMVASTATIN

TABLET, ORALLY DISINTEGRATING;ORAL

SIMVASTATIN

80MG
SIMVASTATIN; SITAGLIPTIN PHOSPHATE

TABLET;ORAL

JUVISYNC
MERCK SHARP DOHME
10MG;EQ
10MG;EQ
20MG;EQ
20MG;EQ
40MG;EQ
40MG;EQ
SIROLIMUS
TABLET;ORAL
RAPAMUNE
PF PRISM CV

N021961 004 Oct 09, 2007

50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE

5MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N202343
N202343
N202343
N202343
N202343
N202343

004
001
005
002
006
003

Sep
Oct
Sep
Oct
Sep
Oct

18,
07,
18,
07,
18,
07,

2012
2011
2012
2011
2012
2011

N021110 003 Feb 23, 2004

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION;ORAL

UCEPHAN

B BRAUN
100MG/ML;100MG/ML

N019530 001 Dec 23, 1987

SODIUM BICARBONATE

INJECTABLE;INJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

ABBOTT
0.9MEQ/ML
1MEQ/ML

N019443 001 Jun 03, 1986

N019443 002 Jun 03, 1986

SODIUM BICARBONATE; TARTARIC ACID

GRANULE, EFFERVESCENT;ORAL

BAROS

MALLINCKRODT INC
460MG/GM;420MG/GM

N018509 001 Aug 07, 1985

SODIUM CHLORIDE

INJECTABLE;INJECTION

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

ABRAXIS PHARM
9MG/ML
SODIUM CHLORIDE

ABBOTT
20GM/100ML
B BRAUN
20GM/100ML
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
450MG/100ML
MILES
450MG/100ML
SODIUM CHLORIDE 0.9%

MEDEFIL INC
18MG/2ML (9MG/ML)
22.5MG/2.5ML (9MG/ML)
27MG/3ML (9MG/ML)
45MG/5ML (9MG/ML)
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

ABBOTT
9MG/ML
MEDEFIL INC
9MG/ML (9MG/ML)
MILES
900MG/100ML
SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER

ABRAXIS PHARM
234MG/ML
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

B BRAUN
3GM/100ML
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER

B BRAUN
5GM/100ML
SOLUTION;IRRIGATION

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

BAXTER HLTHCARE
450MG/100ML
450MG/100ML
HOSPIRA
450MG/100ML
450MG/100ML
SODIUM CHLORIDE IN PLASTIC CONTAINER

MILES
900MG/100ML

A088909 001 Feb 07, 1985

N017013 001

N017038 001

N018184 001

N018503 001

N202832
N202832
N202832
N202832

002
003
004
005

Jan
Jan
Jan
Jan

06,
06,
06,
06,

2012

2012

2012

2012

N019218 001 Jul 13, 1984

N202832 001 Jan 06, 2012

N018502 001

N019329 001 Apr 22, 1987

N019635 003 Mar 09, 1988

N019635 004 Mar 09, 1988

N017864
N018497
N017670
N018380

001

001 Feb 19, 1982

001

001

N018247 001

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6-304(of 347)

DISCONTINUED DRUG PRODUCT LIST

SODIUM CHROMATE CR-51

INJECTABLE;INJECTION

CHROMITOPE SODIUM

BRACCO
SODIUM CHROMATE CR 51

MALLINKRODT NUCLEAR
SODIUM FLUORIDE F-18

INJECTABLE;INTRAVENOUS

FLUORINE F-18

GE HEALTHCARE

SODIUM FLUORIDE F 18

NIH NCI DCTD
SODIUM IODIDE I-123

CAPSULE;ORAL

SODIUM IODIDE I 123

CARDINAL HEALTH 418
GE HEALTHCARE
SOLUTION;ORAL

SODIUM IODIDE I 123

GE HEALTHCARE
SODIUM IODIDE I-131

CAPSULE;ORAL

IODOTOPE

BRACCO
SODIUM IODIDE I 131

CIS
MALLINKRODT NUCLEAR
SODIUM IODIDE I-131

JUBILANT DRAXIMAGE
SOLUTION;ORAL

HICON

JUBILANT DRAXIMAGE

IODOTOPE

BRACCO
SODIUM IODIDE I 131

CIS

2mCi/VIAL
200uCi/ML

N013993 002

N013993 001

100uCi/ML

N016708 001

2mCi/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N017042 001

10-200mCi/ML

N022494 001 Jan 26, 2011

400uCi
100uCi

N018671 003 May 27, 1982

N017630 001

2mCi/ML

N017630 002

1-130mCi
1-150mCi

N010929 001

N010929 003

50uCi
100uCi
0.8-100mCi
15-100uCi

N017316
N017316
N016515
N016517

2-200mCi

N021305 004 Nov 18, 2004

1-250mCi/0.25ML
1-500mCi/0.5ML
1-1000mCi/ML

N021305 002 Jan 24, 2003

N021305 003 Jan 24, 2003

N021305 005 Apr 04, 2006

7-106mCi/BOT

N010929 002

50mCi/ML

N017315 001

SODIUM LACTATE

INJECTABLE;INJECTION

SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

B BRAUN
1.87GM/100ML
BAXTER HLTHCARE
1.87GM/100ML
HOSPIRA
1.87GM/100ML
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER

B BRAUN
1.87GM/100ML
SODIUM MONOFLUOROPHOSPHATE

GEL;DENTAL

EXTRA-STRENGTH AIM

CHESEBROUGH PONDS
PASTE;DENTAL

EXTRA-STRENGTH AIM

CHESEBROUGH PONDS
SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION

NIPRIDE

ROCHE
NITROPRESS

ABBOTT
ABBVIE
HOSPIRA

001

002

002

002

N018186 001

N016692 001

N018249 001

N020004 001 Apr 21, 1992

1.2%

N019518 002 Aug 06, 1986

1.2%

N019518 001 Jun 03, 1987

50MG/VIAL

N017546 001

50MG/VIAL
50MG/VIAL
50MG/VIAL

A071555 001 Nov 16, 1987

N018450 001

A070566 001 Jun 09, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION

SODIUM NITROPRUSSIDE

ABRAXIS PHARM
BAXTER HLTHCARE
TEVA PARENTERAL
SODIUM PHOSPHATE P-32

SOLUTION;INJECTION, ORAL

PHOSPHOTOPE

BRACCO
SODIUM PHOSPHATE P 32

MALLINCKRODT

6-305(of 347)

50MG/VIAL
50MG/VIAL
25MG/ML

A070031 001 Jan 17, 1985

N018581 001 Jul 28, 1982

A073465 001 Mar 30, 1992

1-8mCi/VIAL

N010927 001

0.67mCi/ML
1.5mCi/VIAL

N011777 001

N011777 002

SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET;ORAL

VISICOL

SALIX PHARMS
0.398GM;1.102GM
N021097 001 Sep 21, 2000

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET;ORAL

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE

NOVEL LABS INC
0.398GM;1.102GM
A079247 001 Dec 30, 2011

SODIUM POLYSTYRENE SULFONATE

POWDER;ORAL, RECTAL

SODIUM POLYSTYRENE SULFONATE

CITRUSPHRMA
454GM/BOT
WOCKHARDT
453.6GM/BOT
SUSPENSION;ORAL, RECTAL

SODIUM POLYSTYRENE SULFONATE

MORTON GROVE
15GM/60ML
ROXANE
15GM/60ML

A088717 001 Sep 11, 1984

A088453 001 Nov 17, 1983

SODIUM SUCCINATE

INJECTABLE;INJECTION

SODIUM SUCCINATE

ELKINS SINN

30%

A080516 001

1% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

3% **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N005970 004

250MG/ML

N020166 001 Feb 14, 1992

5MG/VIAL
10MG/VIAL

N019107 001 Oct 17, 1985

N019107 002 Oct 24, 1989

10 IU/VIAL

N017726 001

2 IU/VIAL

N017726 002 Jul 21, 1983

4 IU/VIAL

N017992 001

SODIUM TETRADECYL SULFATE

INJECTABLE;INJECTION

SOTRADECOL

ELKINS SINN

SODIUM THIOSULFATE

INJECTABLE;INJECTION

SODIUM THIOSULFATE

US ARMY
SOMATREM

INJECTABLE;INJECTION

PROTROPIN

GENENTECH
SOMATROPIN

INJECTABLE;INJECTION

ASELLACRIN 10

SERONO
ASELLACRIN 2

SERONO
CRESCORMON

GENENTECH

A040909 001 Dec 03, 2008

A088786 001 Sep 11, 1984

N005970 005

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6-306(of 347)

DISCONTINUED DRUG PRODUCT LIST

SOMATROPIN RECOMBINANT

INJECTABLE;INJECTION

ACCRETROPIN

EMERGENT
BIO-TROPIN

FERRING
HUMATROPE

LILLY
NORDITROPIN

NOVO NORDISK INC

NORDITROPIN NORDIFLEX

NOVO NORDISK INC

NUTROPIN

GENENTECH
NUTROPIN AQ

GENENTECH
NUTROPIN DEPOT

GENENTECH

SAIZEN

EMD SERONO
SEROSTIM

EMD SERONO
ZORBTIVE

EMD SERONO

INJECTABLE;SUBCUTANEOUS

SEROSTIM LQ

EMD SERONO

5MG/ML (5MG/ML)

N021538 001 Jan 23, 2008

4.8MG/VIAL

N019774 001 May 25, 1995

2MG/VIAL

N019640 001 Jun 23, 1987

4MG/VIAL
5MG/1.5ML
8MG/VIAL
10MG/1.5ML
15MG/1.5ML

N019721
N021148
N019721
N021148
N021148

001
001
002
002
003

May
Jun
May
Jun
Jun

08,
20,
08,
20,
20,

1995

2000

1995

2000

2000

5MG/1.5ML
10MG/1.5ML
15MG/1.5ML
30MG/3ML

N021148
N021148
N021148
N021148

004
005
006
007

Oct
Oct
Oct
Mar

01,
01,
01,
10,

2004

2004

2004

2009

5MG/VIAL
10MG/VIAL

N020168 001 Nov 17, 1993

N020168 002 Nov 17, 1993

10MG/2ML (5MG/ML)

N020522 001 Dec 29, 1995

13.5MG/VIAL
18MG/VIAL
22.5MG/VIAL

N021075 001 Dec 22, 1999

N021075 002 Dec 22, 1999

N021075 003 Dec 22, 1999

4MG/VIAL
6MG/VIAL

N019764 005 Jan 16, 2007

N019764 001 Oct 08, 1996

8.8MG/VIAL

N020604 004 Sep 06, 2001

4MG/VIAL
5MG/VIAL
6MG/VIAL

N021597 001 Dec 01, 2003

N021597 002 Dec 01, 2003

N021597 003 Dec 01, 2003

6MG/0.5ML (6MG/0.5ML)

N020604 005 Feb 11, 2005

SORBITOL

SOLUTION;IRRIGATION

SORBITOL 3% IN PLASTIC CONTAINER

BAXTER HLTHCARE
3GM/100ML
SOTALOL HYDROCHLORIDE

TABLET;ORAL

BETAPACE

COVIS PHARMA SARL
BETAPACE AF

COVIS PHARMA SARL

SOTALOL HYDROCHLORIDE

MUTUAL PHARM

WATSON LABS

SOYBEAN OIL

INJECTABLE;INJECTION

LIPOSYN III 10%

HOSPIRA
LIPOSYN III 20%

HOSPIRA

N018512 001 May 27, 1982

320MG

N019865 004 Oct 30, 1992

40MG
60MG
100MG

N021151 006 Apr 02, 2003

N021151 007 Apr 02, 2003

N021151 005 Mar 14, 2003

80MG
80MG
120MG
120MG
160MG
160MG
240MG
80MG
120MG
160MG
240MG

A075515
A076576
A075515
A076576
A075515
A076576
A075515
A075238
A075238
A075238
A075238

10%

N018969 001 Sep 24, 1984

20%

N018970 001 Sep 25, 1984

001
001
004
002
002
003
003
001
002
003
004

Oct
Apr
Oct
Apr
Oct
Apr
Oct
Jul
Jul
Jul
Jul

15,
08,
15,
08,
15,
08,
15,
13,
13,
13,
13,

2001

2004

2001

2004

2001

2004

2001

2000

2000

2000

2000

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-307(of 347)

DISCONTINUED DRUG PRODUCT LIST

SOYBEAN OIL

INJECTABLE;INJECTION

LIPOSYN III 30%

HOSPIRA
SOYACAL 10%

ALPHA THERA
SOYACAL 20%

ALPHA THERA
TRAVAMULSION 10%

BAXTER HLTHCARE
TRAVAMULSION 20%

BAXTER HLTHCARE
SPARFLOXACIN

TABLET;ORAL

ZAGAM

MYLAN
SPECTINOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

TROBICIN

PFIZER
SPIRAPRIL HYDROCHLORIDE

TABLET;ORAL

RENORMAX

SCHERING

SPIRONOLACTONE

TABLET;ORAL

SPIRONOLACTONE

ASCOT
IVAX PHARMS
LEDERLE
MUTUAL PHARM
MYLAN
PUREPAC PHARM
SUPERPHARM
UPSHER SMITH
VANGARD
WARNER CHILCOTT
WATSON LABS
STANOZOLOL

TABLET;ORAL

WINSTROL

LUNDBECK INC

30%

N020181 001 Jan 13, 1998

10%

N018465 001 Jun 29, 1983

20%

N018786 001 Jun 29, 1983

10%

N018660 001 Feb 26, 1982

20%

N018758 001 Feb 15, 1983

200MG

N020677 001 Dec 19, 1996

EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL

N050347 001

N050347 002

3MG
6MG
12MG
24MG

N020240
N020240
N020240
N020240

001
002
003
004

Dec
Dec
Dec
Dec

25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG

A087687
A087108
A087634
A087265
A087086
A087998
A088053
A089364
A087554
A087648
A087952
A086898
A087078

001
001

001

001

001

001
001
001
001

001
001
002
001

Oct 20, 1982

2MG

N012885 001 May 14, 1984

STAVUDINE

CAPSULE;ORAL

ZERIT

BRISTOL MYERS SQUIBB
5MG
CAPSULE, EXTENDED RELEASE;ORAL

ZERIT XR

BRISTOL MYERS SQUIBB 37.5MG
50MG
75MG
100MG
STERILE WATER FOR INJECTION

LIQUID;N/A

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

ABRAXIS PHARM
100%
100%
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

B BRAUN
100%

29,
29,
29,
29,

1994

1994

1994

1994

Oct 14, 1983

Aug 25, 1983

Nov 07, 1986

Feb 01, 1982

Nov 18, 1982

Mar 02, 1982

N020412 001 Jun 24, 1994

N021453
N021453
N021453
N021453

001
002
003
004

Dec
Dec
Dec
Dec

31,
31,
31,
31,

2002

2002

2002

2002

A089099 001 Dec 29, 1987

A089100 001 Dec 29, 1987

N019077 001 Mar 02, 1984

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6-308(of 347)

DISCONTINUED DRUG PRODUCT LIST

STERILE WATER FOR IRRIGATION

LIQUID;IRRIGATION

STERILE WATER IN PLASTIC CONTAINER

MILES
100%
STREPTOMYCIN SULFATE

INJECTABLE;INJECTION

STREPTOMYCIN SULFATE

COPANOS
LILLY

PFIZER

SUCCINYLCHOLINE CHLORIDE

INJECTABLE;INJECTION

ANECTINE

SANDOZ

EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/ML
1GM BASE/VIAL
1GM BASE/2ML
5GM BASE/VIAL
1GM BASE/VIAL
1GM BASE/2.5ML
5GM BASE/VIAL

50MG/ML
500MG/VIAL
1GM/VIAL

QUELICIN PRESERVATIVE FREE

HOSPIRA
50MG/ML
100MG/ML
SUCCINYLCHOLINE CHLORIDE

INTL MEDICATION
100MG/VIAL
ORGANON USA INC
20MG/ML
SUCOSTRIN

APOTHECON
20MG/ML
100MG/ML
SUFENTANIL CITRATE

INJECTABLE;INJECTION

SUFENTANIL CITRATE

WATSON LABS
SULFACETAMIDE SODIUM

OINTMENT;OPHTHALMIC

BLEPH-10

ALLERGAN
CETAMIDE

ALCON
SODIUM SULAMYD

SCHERING

SULFAIR 10

PHARMAFAIR
SOLUTION/DROPS;OPHTHALMIC

BLEPH-30

ALLERGAN
ISOPTO CETAMIDE

ALCON
OCUSULF-10

MIZA PHARMS USA
OCUSULF-30

MIZA PHARMS USA
SODIUM SULAMYD

SCHERING

SODIUM SULFACETAMIDE

AKORN

SOLA BARNES HIND

N018246 001

A060684
A060107
A060404
A060107
A060076
A060111
A060076

001

001

001

002

001

001

002

N008453 003

N008453 001

N008453 004

N008845 002

N008845 004

A085400 001 Feb 04, 1982

A080997 001

N008847 001

N008847 003

EQ 0.05MG BASE/ML

A074406 001 Dec 15, 1995

10%

A084015 001

10%

A080021 001

10% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N005963 002

10%

A088000 001 Dec 22, 1982

30%

A080028 002

15%

A080020 002

10%

A080660 001

30%

A080660 002

10% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

30% **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

N005963 001

10%
15%
30%
10%
10%
30%
30%

A083021
A083021
A083021
A084143
A084145
A084146
A084147

N005963 003

001

002

003

001

001

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-309(of 347)

DISCONTINUED DRUG PRODUCT LIST

SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC

SULF-10

NOVARTIS
SULF-15

NOVARTIS
SULFACEL-15

OPTOPICS
SULFACETAMIDE SODIUM

AKORN
ALCON PHARMS LTD
PHARMAFAIR
SULFAIR 10

PHARMAFAIR
SULFAIR FORTE

PHARMAFAIR
SULFAIR-15

PHARMAFAIR
SULTEN-10

BAUSCH AND LOMB

10%

A080025 001

15%

A089047 001 Oct 31, 1995

15%

A080024 001

30%

30%

10%

A040216 001 May 25, 1999

A089068 001 May 05, 1987

A088947 001 May 17, 1985

10%

A087949 001 Dec 13, 1982

30%

A088385 001 Oct 13, 1983

15%

A088186 001 May 25, 1983

10%

A087818 001 Feb 03, 1983

SULFACYTINE

TABLET;ORAL

RENOQUID

GLENWOOD

250MG

N017569 001

SULFADIAZINE

TABLET;ORAL

SULFADIAZINE

ABBVIE
EVERYLIFE
IMPAX LABS
LANNETT
LEDERLE
LILLY

300MG

500MG

500MG

500MG

500MG

500MG

N004125
A080088
A080081
A080084
N004054
N004122

SULFADIAZINE SODIUM

INJECTABLE;INJECTION

SULFADIAZINE SODIUM

LEDERLE

250MG/ML

N004054 002

SULFADIAZINE; SULFAMERAZINE

SUSPENSION;ORAL

SULFONAMIDES DUPLEX

LILLY

250MG/5ML;250MG/5ML

N006317 007

SULFAMETER

TABLET;ORAL

SULLA

BAYER HLTHCARE

500MG

N016000 002

1GM

A086012 001

500MG

A080273 001

250MG

500MG

N008565 001

N008565 004

500MG/5ML

N013664 002

500MG

N012715 002

1GM

N012715 003

500MG

500MG

500MG

500MG

500MG

A087662
A087189
A086163
A085844
A085053

SULFAMETHIZOLE

TABLET;ORAL

MICROSUL

FOREST PHARMS
PROKLAR

FOREST PHARMS
THIOSULFIL

WYETH AYERST
SULFAMETHOXAZOLE

SUSPENSION;ORAL

GANTANOL

ROCHE
TABLET;ORAL

GANTANOL

ROCHE
GANTANOL-DS

ROCHE
SULFAMETHOXAZOLE

ASCOT
BARR
HEATHER
SANDOZ
WATSON LABS

005

001

001

001

001

002

001 Oct 20, 1982

001 Jul 25, 1983

001

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-310(of 347)

DISCONTINUED DRUG PRODUCT LIST

SULFAMETHOXAZOLE

TABLET;ORAL

SULFAMETHOXAZOLE

UROBAK

SHIONOGI

1GM

A086000 001

500MG

A087307 001

SULFAMETHOXAZOLE; TRIMETHOPRIM

INJECTABLE;INJECTION

BACTRIM

MUTUAL PHARM
80MG/ML;16MG/ML
SEPTRA

MONARCH PHARMS
80MG/ML;16MG/ML
SULFAMETHOXAZOLE AND TRIMETHOPRIM

ABRAXIS PHARM
80MG/ML;16MG/ML
BEDFORD
80MG/ML;16MG/ML
HIKMA MAPLE
80MG/ML;16MG/ML
80MG/ML;16MG/ML
HOSPIRA
80MG/ML;16MG/ML
WATSON LABS
80MG/ML;16MG/ML
SUSPENSION;ORAL
BACTRIM
MUTUAL PHARM
200MG/5ML;40MG/5ML
BACTRIM PEDIATRIC
MUTUAL PHARM
200MG/5ML;40MG/5ML
SEPTRA
MONARCH PHARMS
200MG/5ML;40MG/5ML
SEPTRA GRAPE
MONARCH PHARMS
200MG/5ML;40MG/5ML
SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANI PHARMS INC
200MG/5ML;40MG/5ML
TEVA
200MG/5ML;40MG/5ML
200MG/5ML;40MG/5ML
TEVA PHARMS
200MG/5ML;40MG/5ML
SULFATRIM
STI PHARMA LLC
200MG/5ML;40MG/5ML
SULMEPRIM
USL PHARMA
200MG/5ML;40MG/5ML
SULMEPRIM PEDIATRIC
USL PHARMA
200MG/5ML;40MG/5ML
TRIMETH/SULFA
ALPHARMA US PHARMS
200MG/5ML;40MG/5ML
200MG/5ML;40MG/5ML
NASKA
200MG/5ML;40MG/5ML
TABLET;ORAL
COTRIM
TEVA
400MG;80MG
COTRIM D.S.
TEVA
800MG;160MG
SULFAMETHOPRIM
NOVEL LABS INC
400MG;80MG
SULFAMETHOPRIM-DS
NOVEL LABS INC
800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM
HEATHER
400MG;80MG
800MG;160MG
INTERPHARM
400MG;80MG
800MG;160MG
MARTEC USA LLC
400MG;80MG
MUTUAL PHARM
400MG;80MG
400MG;80MG
PLIVA
400MG;80MG
800MG;160MG
ROXANE
400MG;80MG
SANDOZ
400MG;80MG
400MG;80MG
800MG;160MG
TEVA
400MG;80MG
800MG;160MG
USL PHARMA
400MG;80MG
800MG;160MG
WATSON LABS
400MG;80MG
400MG;80MG

N018374 001

N018452 001

A070223
A072383
A070627
A070628
A073199
A071556

001
001
001
001
001
001

Dec
Apr
Dec
Dec
Sep
Dec

29,
29,
29,
29,
11,
29,

1987
1992
1987
1987
1992
1987

N017560 001
N017560 002
N017598 001
N017598 002 Feb 12, 1986
A070028
N018812
N018812
A077612

001
001
002
001

Jun
Jan
Jun
Nov

02,
28,
10,
13,

1987
1983
1983
2006

N018615 002 Jan 07, 1983

A070063 001 Aug 01, 1986
A070064 001 Aug 01, 1986
A072289 001 May 23, 1988
A072398 001 May 23, 1988
A072399 001 May 23, 1988

A070034 001 May 16, 1985

A070048 001 Mar 18, 1985
A070022 001 Feb 15, 1985
A070032 001 Feb 15, 1985
N018946
N018946
A071299
A071300
A072408
A070006
A071016
A070215
A070216
A072768
A070889
N018598
A070890
N018242
N018242
A070203
A070204
A070002
N018852

001
002
001
001
001
001
001
001
001
001
001
003
001
001
002
001
001
001
001

Aug
Aug
Oct
Oct
Dec
Nov
Aug
Sep
Sep
Aug
Nov
May
Nov

10,
10,
27,
27,
07,
14,
25,
10,
10,
30,
13,
19,
13,

1984
1984
1987
1987
1988
1984
1986
1985
1985
1991
1986
1982
1986

Nov
Nov
Nov
May

08,
08,
07,
09,

1985
1985
1984
1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-311(of 347)

DISCONTINUED DRUG PRODUCT LIST

SULFAMETHOXAZOLE; TRIMETHOPRIM

TABLET;ORAL

SULFAMETHOXAZOLE AND TRIMETHOPRIM

800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

MARTEC USA LLC
800MG;160MG
MUTUAL PHARM
800MG;160MG
ROXANE
800MG;160MG
SANDOZ
800MG;160MG
WATSON LABS
800MG;160MG
SULFATRIM-DS
SUPERPHARM
800MG;160MG
SULFATRIM-SS
SUPERPHARM
400MG;80MG
UROPLUS DS
SHIONOGI
800MG;160MG
UROPLUS SS
SHIONOGI
400MG;80MG
SULFANILAMIDE
CREAM;VAGINAL
SULFANILAMIDE
G AND W LABS INC
SUPPOSITORY;VAGINAL
AVC
MEDA PHARMS
SULFAPHENAZOLE
SUSPENSION;ORAL
SULFABID
PHARM RES ASSOC
TABLET;ORAL
SULFABID
PURDUE FREDERICK
SULFAPYRIDINE
TABLET;ORAL
SULFAPYRIDINE
LILLY
SULFASALAZINE
SUSPENSION;ORAL
AZULFIDINE
PHARMACIA AND UPJOHN
TABLET;ORAL
S.A.S.-500
SOLVAY
SULFASALAZINE
HERITAGE PHARMS INC
MUTUAL PHARM
SANDOZ
SUPERPHARM
WATSON LABS
TABLET, DELAYED RELEASE;ORAL
SULFASALAZINE
WATSON LABS
SULFINPYRAZONE
CAPSULE;ORAL
ANTURANE
NOVARTIS

SULFINPYRAZONE
BARR
IVAX PHARMS
PAR PHARM
VANGARD
TABLET;ORAL
ANTURANE
NOVARTIS

A070000 001 Nov 07, 1984

A072417
A070007
A072769
N018598
N018854

001
001
001
004
001

Dec
Nov
Aug
May
May

07,
14,
30,
19,
09,

1988
1984
1991
1982
1983

A070066 001 Jun 24, 1985

A070065 002 Jun 24, 1985
A071816 001 Sep 28, 1987
A071815 001 Sep 28, 1987

15%

A088718 001 Sep 19, 1985

1.05GM

N006530 004 Jan 27, 1987

500MG/5ML

N013093 001

500MG

N013092 002

500MG

N000159 001

250MG/5ML

N018605 001

500MG

A083450 001

500MG
500MG
500MG
500MG
500MG
500MG

A080197
A089590
A086184
A089339
A084964
A087197

500MG

A088052 001 May 24, 1983

200MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N011556 004

200MG
200MG
200MG
200MG

A087666
A087770
A088934
A088666

100MG **Federal Register determination

that product was not discontinued or
withdrawn for safety or efficacy
reasons**

N011556 003

001
001 Oct 19, 1987
001
001 Oct 26, 1987
001
001

001
001
001
001

Sep
Nov
Sep
Feb

17,
19,
06,
17,

1982
1982
1985
1984

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-312(of 347)

DISCONTINUED DRUG PRODUCT LIST

SULFINPYRAZONE

TABLET;ORAL

SULFINPYRAZONE

BARR

IVAX PHARMS

PAR PHARM

WATSON LABS

SULFISOXAZOLE

TABLET;ORAL

GANTRISIN

ROCHE

SOSOL

MK LABS

SOXAZOLE

ALRA

SULFALAR

PARKE DAVIS

SULFISOXAZOLE

ANI PHARMS INC

BARR

HEATHER

IMPAX LABS

LANNETT

LEDERLE

PHARMERAL

PUREPAC PHARM

ROXANE

SANDOZ

VALEANT PHARM INTL

VITARINE

WATSON LABS

WEST WARD

SULSOXIN

SOLVAY

SULFISOXAZOLE ACETYL

EMULSION;ORAL

LIPO GANTRISIN

ROCHE

SUSPENSION;ORAL

GANTRISIN PEDIATRIC

ROCHE

SYRUP;ORAL

GANTRISIN

ROCHE

SULFISOXAZOLE DIOLAMINE

INJECTABLE;INJECTION

GANTRISIN

ROCHE

OINTMENT;OPHTHALMIC

GANTRISIN

ROCHE

SOLUTION/DROPS;OPHTHALMIC

GANTRISIN

ROCHE

SULFISOXAZOLE DIOLAMINE

SOLA BARNES HIND

100MG

100MG

100MG

100MG

A087665
A087769
A088933
A087667

001
001
001
001

500MG

N006525 001

500MG

A080036 001

500MG

A080366 001

500MG

A084955 001

500MG

500MG

500MG

500MG

500MG

500MG

500MG

500MG

500MG

500MG

500MG

500MG

500MG

500MG

A080142
A084031
A080189
A080109
A080085
A087649
A084385
A080087
A080082
A085628
A080268
A087332
A085534
A080379

500MG

A080040 001

EQ 1GM BASE/5ML

N009182 009

EQ 500MG BASE/5ML

N009182 004

EQ 500MG BASE/5ML

N009182 002

EQ 400MG BASE/ML

N006917 001

EQ 4% BASE

N008414 002

EQ 4% BASE

N007757 002

EQ 4% BASE

A084148 001

001

001

001

001

001

001

001

001

001

001

002

001

001

001

SULFOXONE SODIUM

TABLET, DELAYED RELEASE;ORAL

DIASONE SODIUM

ABBVIE

165MG

N006044 003

SULFUR

POWDER;TOPICAL

BENSULFOID

POYTHRESS

N002918 001

33.32%

Sep
Jun
Sep
May

17,
01,
06,
26,

1982

1982

1985

1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-313(of 347)

DISCONTINUED DRUG PRODUCT LIST

SULINDAC

TABLET;ORAL

CLINORIL

MERCK

SULINDAC

ANI PHARMS INC
SANDOZ
SUMATRIPTAN

SPRAY;NASAL

IMITREX

GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS

SUMATRIPTAN SUCCINATE

FRESENIUS KABI USA
SANDOZ
TEVA PARENTERAL
TABLET;ORAL

SUMATRIPTAN SUCCINATE

MYLAN

ROXANE

SANDOZ

TEVA

SUPROFEN

SOLUTION/DROPS;OPHTHALMIC

PROFENAL

ALCON
SUTILAINS

OINTMENT;TOPICAL

TRAVASE

ABBOTT

TACRINE HYDROCHLORIDE

CAPSULE;ORAL

COGNEX

SHIONOGI INC

150MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

200MG

N017911 002

150MG
200MG
150MG
200MG

A072972
A072973
A072712
A072713

10MG/SPRAY

N020626 002 Aug 26, 1997

EQ
EQ
EQ
EQ
EQ
EQ

6MG
4MG
4MG
6MG
4MG
6MG

BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE

(EQ
(EQ
(EQ
(EQ
(EQ
(EQ

12MG BASE/ML)
8MG BASE/ML)
8MG BASE/ML)
12MG BASE/ML)
8MG BASE/ML)
12MG BASE/ML)

N017911 001

001
001
001
001

Feb
Feb
Aug
Aug

28,
28,
30,
30,

1992

1992

1991

1991

A079240
A079240
A078067
A078067
A078318
A078318

002
001
002
001
001
002

Sep
Sep
Feb
Feb
Feb
Feb

18,
18,
06,
06,
06,
06,

2009

2009

2009

2009

2009

2009

A077163
A077163
A077163
A078241
A078241
A078241
A076976
A076976
A076976
A076840
A076840
A076840

001
002
003
001
002
003
001
002
003
001
002
003

Nov
Nov
Nov
Aug
Aug
Aug
Aug
Aug
Aug
Feb
Feb
Feb

02,
02,
02,
10,
10,
10,
10,
10,
10,
09,
09,
09,

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

1%

N019387 001 Dec 23, 1988

82,000 UNITS/GM **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N012828 001

EQ
EQ
EQ
EQ

N020070
N020070
N020070
N020070

10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE

001
002
003
004

Sep
Sep
Sep
Sep

09,
09,
09,
09,

1993

1993

1993

1993

TACROLIMUS

CAPSULE;ORAL

TACROLIMUS

WATSON LABS

EQ 5MG BASE

A090402 001 Jul 01, 2010

TALBUTAL

TABLET;ORAL

LOTUSATE

SANOFI AVENTIS US

120MG

N009410 005

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-314(of 347)

DISCONTINUED DRUG PRODUCT LIST

TAMOXIFEN CITRATE

TABLET;ORAL

NOLVADEX

ASTRAZENECA

TAMOXIFEN CITRATE

AEGIS PHARMS

IVAX SUB TEVA PHARMS

PHARMACHEMIE

ROXANE

TEVA

EQ 10MG BASE

EQ 20MG BASE

N017970 001

N017970 002 Mar 21, 1994

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A076398
A076398
A075740
A075740
A074539
A076027
A076027
A074504
A074504

10MG
20MG
10MG
20MG
10MG
10MG
20MG
10MG
20MG

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

TECHNETIUM TC-99M ALBUMIN AGGREGATED

INJECTABLE;INJECTION

TC 99M-LUNGAGGREGATE

GE HEALTHCARE
5mCi/ML

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE;INJECTION

A-N STANNOUS AGGREGATED ALBUMIN

SYNCOR PHARMS

N/A

AN-MAA

PHARMALUCENCE

N/A

LUNGAGGREGATE REAGENT

GE HEALTHCARE

N/A

MACROTEC

BRACCO

N/A

TECHNESCAN MAA

MALLINCKRODT

N/A

TECHNETIUM TC 99M MAA

GE HEALTHCARE

N/A

001
002
001
002
001
001
002
001
002

Mar
Mar
Feb
Feb
Mar
Feb
Feb
Apr
Apr

31,
31,
20,
20,
31,
20,
20,
28,
28,

2003

2003

2003

2003

2003

2003

2003

2003

2003

N017848 001

N017916 001

N017792 001

N017838 001

N017833 001

N017842 001

N017773 001

TECHNETIUM TC-99M ALBUMIN COLLOID KIT

INJECTABLE;INJECTION

MICROLITE

PHARMALUCENCE
N/A

N018263 001 Mar 25, 1983

TECHNETIUM TC-99M ALBUMIN KIT

INJECTABLE;INJECTION

TECHNETIUM TC 99M HSA

GE HEALTHCARE

N017775 001

N/A

TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT

INJECTABLE;INJECTION

INSTANT MICROSPHERES

3M
N/A

N017832 001

TECHNETIUM TC-99M APCITIDE

INJECTABLE;INJECTION

ACUTECT

CIS BIO INTL SA

N/A

N020887 001 Sep 14, 1998

TECHNETIUM TC-99M DEPREOTIDE

INJECTABLE;INJECTION

NEO TECT KIT

CIS BIO INTL SA

N/A

N021012 001 Aug 03, 1999

TECHNETIUM TC-99M ETIDRONATE KIT

INJECTABLE;INJECTION

CINTICHEM TECHNETIUM 99M HEDSPA

GE HEALTHCARE
N/A

MPI STANNOUS DIPHOSPHONATE

GE HEALTHCARE
N/A

OSTEOSCAN

MALLINCKRODT
N/A

TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT

GE HEALTHCARE
N/A

N017653 001

N017667 001

N017454 001

N017562 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

TECHNETIUM TC-99M FERPENTETATE KIT

INJECTABLE;INJECTION

RENOTEC

BRACCO
N/A

TECHNETIUM TC-99M GLUCEPTATE KIT

INJECTABLE;INJECTION

GLUCOSCAN
BRISTOL MYERS SQUIBB
N/A
TECHNESCAN GLUCEPTATE
DRAXIMAGE
N/A

6-315(of 347)

N017045 001

N017907 001

N018272 001 Jan 27, 1982

TECHNETIUM TC-99M LIDOFENIN KIT

INJECTABLE;INJECTION

TECHNESCAN HIDA

DRAXIMAGE
N/A

N018489 001 Oct 31, 1986

TECHNETIUM TC-99M MEDRONATE

INJECTABLE;INJECTION

DRAXIMAGE MDP-10

JUBILANT DRAXIMAGE

N018035 001

N/A

TECHNETIUM TC-99M MEDRONATE KIT

INJECTABLE;INJECTION

AMERSCAN MDP KIT

GE HEALTHCARE
N/A

OSTEOLITE

PHARMALUCENCE
N/A

TECHNETIUM TC 99M MPI MDP

GE HEALTHCARE
N/A

N/A

TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE;INJECTION

MPI DTPA KIT - CHELATE

GE HEALTHCARE
N/A

TECHNETIUM TC-99M PENTETATE KIT

GE HEALTHCARE
N/A

N018335 001 Aug 05, 1982

N017972 001

N018141 001

N018141 002 Jun 12, 1989

N017255 001

N017264 002

TECHNETIUM TC-99M POLYPHOSPHATE KIT

INJECTABLE;INJECTION

SODIUM POLYPHOSPHATE-TIN KIT

GE HEALTHCARE
N/A

N017664 001

TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT

INJECTABLE;INJECTION

PYROLITE

PHARMALUCENCE
N/A

N017684 001

TECHNETIUM TC-99M PYROPHOSPHATE KIT

INJECTABLE;INJECTION

PHOSPHOTEC

BRACCO
N/A

N017680 001

TECHNETIUM TC-99M RED BLOOD CELL KIT

INJECTABLE;INJECTION

RBC-SCAN

CADEMA
N/A

N020063 001 Jun 11, 1992

TECHNETIUM TC-99M SESTAMIBI KIT

INJECTABLE;INJECTION

MIRALUMA

LANTHEUS MEDCL
N/A

N019785 003 May 23, 1997

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTION;INJECTION, ORAL

SODIUM PERTECHNETATE TC 99M

GE HEALTHCARE
2-100mCi/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

MALLINCKRODT
10-60mCi/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

PHARMALUCENCE
12mCi/ML

24mCi/ML

48mCi/ML

N017471 001

N017725 001

N017321 001

N017321 002

N017321 003

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-316(of 347)

DISCONTINUED DRUG PRODUCT LIST

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION;INJECTION, ORAL

MINITEC

BRACCO
0.22-2.22 CI/GENERATOR
SOLUTION;INTRAVENOUS

TECHNELITE

LANTHEUS MEDCL
0.0083-2.7 CI/GENERATOR
ULTRA-TECHNEKOW FM

MALLINCKRODT
0.25-3 CI/GENERATOR
SOLUTION;INTRAVENOUS, ORAL

TECHNETIUM TC 99M GENERATOR

GE HEALTHCARE
830-16600mCi/GENERATOR
TECHNETIUM TC-99M SULFUR COLLOID

SOLUTION;INJECTION, ORAL

TECHNETIUM TC 99M SULFUR COLLOID

GE HEALTHCARE
4mCi/ML
SOLUTION;ORAL

TECHNETIUM TC 99M SULFUR COLLOID

MALLINCKRODT
3mCi/ML
TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION;INJECTION, ORAL

TECHNECOLL

MALLINCKRODT
N/A
TECHNETIUM TC 99M TSC

GE HEALTHCARE
N/A
TESULOID

BRACCO
N/A
TECHNETIUM TC-99M TEBOROXIME KIT

INJECTABLE;INJECTION

CARDIOTEC
BRACCO
N/A
TEGASEROD MALEATE
TABLET;ORAL
ZELNORM
NOVARTIS

N017339 001

N017771 001

N017243 002

N017693 001

N017456 001

N017724 001

N017059 001

N017784 001

N016923 001

N019928 001 Dec 19, 1990

EQ 2MG BASE
EQ 6MG BASE

N021200 001 Jul 24, 2002

N021200 002 Jul 24, 2002

TELAPREVIR
TABLET;ORAL
INCIVEK
VERTEX PHARMS

375MG

N201917 001 May 23, 2011

TELBIVUDINE
SOLUTION;ORAL
TYZEKA
NOVARTIS

100MG/5ML

N022154 001 Apr 28, 2009

15MG
30MG

A070564 001 Oct 15, 1985

A070547 001 Oct 15, 1985

15MG
30MG
15MG
30MG
15MG
30MG
15MG
15MG
30MG
30MG

A071708
A071709
A071174
A071175
A070489
A070490
A070383
A071446
A070384
A071447

EQ 1MG BASE **Federal Register

determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 2MG BASE **Federal Register
determination that product was not

N020347 001 Dec 14, 1994

TEMAZEPAM
CAPSULE;ORAL
TEMAZ
QUANTUM PHARMICS
TEMAZEPAM
DURAMED PHARMS BARR
MUTUAL PHARM
USL PHARMA
WATSON LABS

TERAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
HYTRIN
ABBOTT

001
001
001
001
001
001
001
001
001
001

Sep
Sep
Jul
Jul
Jul
Jul
Mar
May
Mar
May

29,
29,
10,
10,
07,
07,
23,
21,
23,
21,

1988
1988
1986
1986
1986
1986
1987
1993
1987
1993

N020347 002 Dec 14, 1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-317(of 347)

DISCONTINUED DRUG PRODUCT LIST

TERAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

HYTRIN

discontinued or withdrawn for safety or

efficacy reasons**

EQ 5MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 10MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

TERAZOSIN HYDROCHLORIDE

MYLAN TECHNOLOGIES

RANBAXY LABS LTD

SANDOZ

TABLET;ORAL

HYTRIN

ABBOTT

TERAZOSIN HYDROCHLORIDE

IVAX SUB TEVA PHARMS

SANDOZ

TEVA

TERBINAFINE

GEL;TOPICAL

LAMISIL

GLAXOSMITHKLINE CONS
TERBINAFINE HYDROCHLORIDE

CREAM;TOPICAL

LAMISIL

NOVARTIS
SOLUTION;TOPICAL

LAMISIL

GLAXOSMITHKLINE CONS
TABLET;ORAL

TERBINAFINE HYDROCHLORIDE

GEDEON RICHTER USA
MYLAN
ROXANE
WOCKHARDT

N020347 003 Dec 14, 1994

N020347 004 Dec 14, 1994

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1MG BASE
2MG BASE
5MG BASE
10MG BASE
1MG BASE
2MG BASE
5MG BASE
10MG BASE
1MG BASE
2MG BASE
5MG BASE
10MG BASE

A075384
A075384
A075384
A075384
A076021
A076021
A076021
A076021
A075667
A075667
A075667
A075667

001
002
003
004
001
002
003
004
001
002
003
004

Dec
Dec
Dec
Dec
Aug
Aug
Aug
Aug
Jul
Jul
Jul
Jul

01,
01,
01,
01,
22,
22,
22,
22,
28,
28,
28,
28,

2000

2000

2000

2000

2002

2002

2002

2002

2000

2000

2000

2000

EQ
EQ
EQ
EQ

1MG BASE
2MG BASE
5MG BASE
10MG BASE

N019057
N019057
N019057
N019057

001
002
003
004

Aug
Aug
Aug
Aug

07,
07,
07,
07,

1987

1987

1987

1987

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1MG BASE
2MG BASE
5MG BASE
10MG BASE
1MG BASE
1MG BASE
2MG BASE
2MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
1MG BASE
2MG BASE
5MG BASE
10MG BASE

A074530
A074530
A074530
A074530
A074315
A074657
A074315
A074657
A074315
A074657
A074315
A074657
A074446
A074446
A074446
A074446

001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004

Apr
Apr
Apr
Apr
Dec
Apr
Dec
Apr
Dec
Apr
Dec
Apr
May
May
May
May

21,
21,
21,
21,
31,
28,
31,
28,
31,
28,
31,
28,
18,
18,
18,
18,

2000

2000

2000

2000

1998

2000

1998

2000

1998

2000

1998

2000

2000

2000

2000

2000

1%

N020846 001 Apr 29, 1998

1%

N020192 001 Dec 30, 1992

1%

N020749 001 Oct 17, 1997

EQ
EQ
EQ
EQ

250MG
250MG
250MG
250MG

BASE
BASE
BASE
BASE

A077065
A077136
A077223
A078229

001
001
001
001

Jul
Jul
Jul
Jul

02,
02,
02,
02,

2007

2007

2007

2007

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

TERBUTALINE SULFATE

AEROSOL, METERED;INHALATION

BRETHAIRE

NOVARTIS

BRICANYL

SANOFI AVENTIS US

INJECTABLE;INJECTION

BRETHINE

AAIPHARMA LLC

BRICANYL

SANOFI AVENTIS US

TERBUTALINE SULFATE

TEVA PHARMS USA

TABLET;ORAL

BRETHINE

LEHIGH VALLEY

6-318(of 347)

0.2MG/INH

N018762 001 Aug 17, 1984

0.2MG/INH

N018000 001 Mar 19, 1985

1MG/ML

N018571 001

1MG/ML

N017466 001

1MG/ML

A076853 001 Jul 20, 2004

2.5MG

5MG

N017849 001

N017849 002

2.5MG

5MG

N017618 001

N017618 002

TERCONAZOLE

SUPPOSITORY;VAGINAL

TERCONAZOLE

FOUGERA PHARMS

80MG

A076850 001 Jul 12, 2006

TERIPARATIDE ACETATE

INJECTABLE;INJECTION

PARATHAR

SANOFI AVENTIS US

200 UNITS/VIAL

N019498 001 Dec 23, 1987

BRICANYL

SANOFI AVENTIS US

TERIPARATIDE RECOMBINANT HUMAN

INJECTABLE;SUBCUTANEOUS

FORTEO

LILLY

0.75MG/3ML (0.25MG/ML)

N021318 001 Nov 26, 2002

TESAMORELIN ACETATE

POWDER;SUBCUTANEOUS

EGRIFTA

THERATECHNOLOGIES

EQ 2MG BASE/VIAL

N022505 002 Nov 29, 2011

100MG/ML

N016119 001

50MG

250MG

N016118 001

N016118 002

TESTOLACTONE

INJECTABLE;INJECTION

TESLAC

BRISTOL MYERS SQUIBB

TABLET;ORAL

TESLAC

BRISTOL MYERS SQUIBB

TESTOSTERONE

FILM, EXTENDED RELEASE;TRANSDERMAL

ANDRODERM

ACTAVIS LABS UT INC

2.5MG/24HR

5MG/24HR

TESTODERM

ALZA

4MG/24HR

6MG/24HR

TESTODERM TTS

ALZA

5MG/24HR

INJECTABLE;INJECTION

TESTOSTERONE

WATSON LABS

25MG/ML

50MG/ML

100MG/ML

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION

DEPO-TESTOSTERONE

PHARMACIA AND UPJOHN

TESTOSTERONE CYPIONATE

WATSON LABS

N020489 001 Sep 29, 1995

N020489 002 May 02, 1997

N019762 001 Oct 12, 1993

N019762 002 Oct 12, 1993

N020791 001 Dec 18, 1997

A086420 001 May 10, 1983

A086419 001 Aug 23, 1983

A086417 001 Jul 07, 1983

50MG/ML

A085635 001

100MG/ML

100MG/ML

200MG/ML

A084401 001

A086029 001

A084401 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-319(of 347)

DISCONTINUED DRUG PRODUCT LIST

TESTOSTERONE ENANTHATE

INJECTABLE;INJECTION

DELATESTRYL

ENDO PHARMS

TESTOSTERONE ENANTHATE

WATSON LABS

TESTOSTERONE PROPIONATE

INJECTABLE;INJECTION

TESTOSTERONE PROPIONATE

BEL MAR

ELKINS SINN

LILLY

WATSON LABS

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

BRISTACYCLINE

BRISTOL

CYCLOPAR

WARNER CHILCOTT

PANMYCIN

PHARMACIA AND UPJOHN

RETET

SOLVAY

ROBITET

WYETH AYERST

SUMYCIN

APOTHECON

TETRACHEL

ANGUS

200MG/ML

N009165 001

100MG/ML

100MG/ML

200MG/ML

A083667 001

A085599 001

A083667 002

25MG/ML

50MG/ML

100MG/ML

25MG/ML

50MG/ML

25MG/ML

25MG/ML

50MG/ML

50MG/ML

100MG/ML

100MG/ML

A080741
A080742
A080743
A080276
A080254
A080188
A085490
A080188
A085490
A080188
A083595

001

001

001

001

002

001

001

002

002

003

003

250MG

250MG

500MG

500MG

A061658
A061888
A061658
A061888

001

001

002

002

250MG

250MG

250MG

500MG

500MG

A061725
A062175
A062332
A061725
A062332

001

001

001

002

002

250MG

A060347 001

250MG

500MG

A061443 001

A061443 002

250MG

500MG

A061734 001

A061734 002

100MG

125MG

250MG

500MG

A060429
A060429
A060429
A060429

250MG

500MG

A060343 001

A060343 003

TETRACYCLINE HYDROCHLORIDE

ABBOTT

250MG

500MG

CHARTWELL CIENCA

250MG

500MG

ELKINS SINN

250MG

FERRANTE

125MG

250MG

HEATHER

250MG

500MG

HIKMA PHARMS LLC

250MG

500MG

IVAX SUB TEVA PHARMS
250MG

500MG

MAST MM

250MG

MUTUAL PHARM

250MG

500MG

MYLAN

250MG

500MG

PUREPAC PHARM

250MG

A061802
A061802
A062752
A062752
A060059
A060173
A060173
A061148
A061148
A060768
A060768
A060704
A060704
A062085
A060736
A060736
A060783
A060783
A060290

002

004

001

003

001

002

001 Aug 12, 1988

002 Aug 12, 1988

001

001

002

001

002

001

002

001

002

001

001

002

001

002

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-320(of 347)

DISCONTINUED DRUG PRODUCT LIST

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

TETRACYCLINE HYDROCHLORIDE

PVT FORM

ROXANE

SANDOZ

SUPERPHARM

VALEANT PHARM INTL

WARNER CHILCOTT

WATSON LABS

WYETH AYERST

500MG

250MG

500MG

500MG

250MG

250MG

500MG

250MG

500MG

250MG

500MG

250MG

250MG

500MG

500MG

250MG

500MG

A060290
A062686
A062686
A061214
A061471
A062540
A062540
A060471
A060471
A062300
A062300
A062103
A062343
A062103
A062343
A061685
A061685

TETRACYN

PFIPHARMECS

250MG

500MG

FIBER, EXTENDED RELEASE;PERIODONTAL

ACTISITE

SCHIFF AND CO

12.7MG/FIBER

FOR SOLUTION;TOPICAL

TOPICYCLINE

SHIRE

2.2MG/ML

INJECTABLE;INJECTION

ACHROMYCIN

LEDERLE

250MG/VIAL

500MG/VIAL

TETRACYN

PFIZER

250MG/VIAL

500MG/VIAL

OINTMENT;OPHTHALMIC

ACHROMYCIN

STORZ

10MG/GM

SUSPENSION;ORAL

ACHROMYCIN V

LEDERLE

125MG/5ML

SUMYCIN

PAR PHARM

125MG/5ML

TETRACYCLINE HYDROCHLORIDE

ALPHARMA US PHARMS

125MG/5ML

FERRANTE

125MG/5ML

PROTER

125MG/5ML

PUREPAC PHARM

125MG/5ML

TETRACYN

PFIPHARMECS

125MG/5ML

TETRAMED

IVAX SUB TEVA PHARMS
125MG/5ML

SUSPENSION/DROPS;OPHTHALMIC

ACHROMYCIN

STORZ

1%

TABLET;ORAL

PANMYCIN

PHARMACIA AND UPJOHN
250MG

500MG

SUMYCIN

PAR PHARM

50MG

100MG

250MG

500MG

TETRACYCLINE PHOSPHATE COMPLEX

CAPSULE;ORAL

TETREX

BRISTOL

EQ
EQ
EQ
EQ

100MG
250MG
250MG
250MG

HCL

HCL

HCL

HCL

002

001
002
002

001

001
002
001

002

001

002

001

001

002

002

001

002

Jul 24, 1986

Jul 24, 1986

Mar 21, 1985

Mar 21, 1985

A060082 003

A060082 004

N050653 001 Mar 25, 1994

N050493 001

N050273 002

N050273 003

A060096 001

A060096 002

N050266 001

N050263 002

A060400 001

A060633
A060174
A060446
A060291

001

001

001

001

A060095 001

A061468 001

N050268 001

A061705 001

A061705 002

A061147
A061147
A061147
A061147

003

002

001

004

A061653
A061653
A061889
N050212

001

002

002

002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-321(of 347)

DISCONTINUED DRUG PRODUCT LIST

TETRACYCLINE PHOSPHATE COMPLEX

CAPSULE;ORAL

TETREX

THALLOUS CHLORIDE TL-201

INJECTABLE;INJECTION

THALLOUS CHLORIDE TL 201

BRACCO
TRACE LIFE
INJECTABLE;INTRAVENOUS

THALLOUS CHLORIDE TL 201

MALLINKRODT NUCLEAR
THEOPHYLLINE

CAPSULE;ORAL

BRONKODYL

SANOFI AVENTIS US
ELIXOPHYLLIN

FOREST LABS
SOMOPHYLLIN-T

FISONS

THEOPHYLLINE

KV PHARM

EQ 500MG HCL
EQ 500MG HCL
EQ 500MG HCL

A061653 003

A061889 001

N050212 003

1mCi/ML
1mCi/ML

N018548 001 Dec 30, 1982

A075569 001 Nov 21, 2001

2mCi/ML

A077698 001 Nov 09, 2006

100MG
200MG

A085264 001

A085264 002

100MG
200MG

A085545 001 Jul 31, 1984

A083921 001 Jul 31, 1984

100MG
200MG
250MG

A087155 001 Feb 25, 1985

A087155 002 Feb 25, 1985

A087155 003 Feb 25, 1985

100MG
200MG
SCHERER RP
100MG
200MG
250MG
CAPSULE, EXTENDED RELEASE;ORAL

AEROLATE III

FLEMING PHARMS
65MG
AEROLATE JR

FLEMING PHARMS
130MG
AEROLATE SR

FLEMING PHARMS
260MG
ELIXOPHYLLIN SR

FOREST LABS
125MG
250MG
SLO-BID

SANOFI AVENTIS US
50MG
75MG
100MG
125MG
200MG
300MG
SLO-PHYLLIN

SANOFI AVENTIS US
60MG
125MG
250MG
SOMOPHYLLIN-CRT

GRAHAM DM
50MG
100MG
200MG
250MG
300MG
THEO-DUR

SCHERING
50MG
75MG
125MG
200MG
THEOBID

WHITBY
260MG
THEOBID JR.

WHITBY
130MG
THEOCLEAR L.A.-130

SCHWARZ PHARMA
130MG

A085263
A085263
A084731
A084731
A084731

001

002

002 Nov 07, 1986

001 Nov 07, 1986

003 Nov 07, 1986

A085075 003 Nov 24, 1986

A085075 002 Nov 24, 1986

A085075 001 Nov 24, 1986

A086826 001 Jan 29, 1985

A086826 002 Jan 29, 1985

A088269
A089539
A087892
A089540
A087893
A087894

001
001
001
001
001
001

Jan
May
Jan
May
Jan
Jan

31,
10,
31,
10,
31,
31,

1985

1989

1985

1989

1985

1985

A085206 001 May 24, 1982

A085203 001 May 24, 1982

A085205 001 May 24, 1982

A087763
A087194
A088382
A087193
A088383

001 Feb 27, 1985

001

001 Feb 27, 1985

001

001 Feb 27, 1985

A088022
A088015
A088016
A087995

001
001
001
001

Sep
Sep
Sep
Sep

10,
10,
10,
10,

1985

1985

1985

1985

A085983 001 Mar 20, 1985

A087854 001 Mar 20, 1985

A086569 001 May 27, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-322(of 347)

DISCONTINUED DRUG PRODUCT LIST

THEOPHYLLINE

CAPSULE, EXTENDED RELEASE;ORAL

THEOCLEAR L.A.-260

SCHWARZ PHARMA
260MG
THEOPHYL-SR

ORTHO MCNEIL PHARM
125MG
250MG
THEOPHYLLINE

CENT PHARMS
125MG
250MG
HOSPIRA
100MG
200MG
300MG
INWOOD LABS
100MG
125MG
200MG
300MG
SANDOZ
260MG
THEOPHYLLINE-SR

SCHERER RP
300MG
THEOVENT

SCHERING
125MG
250MG
ELIXIR;ORAL

ELIXOMIN

CENCI
80MG/15ML
LANOPHYLLIN

LANNETT
80MG/15ML
THEOLIXIR

PANRAY
80MG/15ML
THEOPHYL-225

ORTHO MCNEIL PHARM
112.5MG/15ML
THEOPHYLLINE

ALPHARMA US PHARMS
80MG/15ML
CENCI
80MG/15ML
HALSEY
80MG/15ML
PERRIGO
80MG/15ML
PHARM ASSOC
80MG/15ML
PRECISION DOSE
80MG/15ML
ROXANE
80MG/15ML
TARO
80MG/15ML
WOCKHARDT
80MG/15ML
INJECTABLE;INJECTION

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
40MG/100ML
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
80MG/100ML
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
160MG/100ML
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
200MG/100ML
200MG/100ML
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN
4MG/ML
400MG/100ML
400MG/100ML
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE
4MG/ML
40MG/100ML
80MG/100ML
160MG/100ML
200MG/100ML
320MG/100ML
400MG/100ML
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA INC
80MG/100ML
200MG/100ML
400MG/100ML
SOLUTION;ORAL

AEROLATE

FLEMING PHARMS
150MG/15ML

A086569 002 May 27, 1982

A086480 001 Feb 08, 1985

A086471 001 Feb 08, 1985

A088654
A088689
A089976
A089977
A089932
A040052
A040052
A040052
A040052
A087462

001
001
001
001
001
001
002
003
004
001

Feb
Feb
Jan
Jan
Jan
Feb
Feb
Feb
Feb
May

12,
12,
04,
04,
04,
14,
14,
14,
14,
11,

1985

1985

1995

1995

1995

1994

1994

1994

1994

1982

A088255 001 Jun 12, 1986

A087010 001 Jan 31, 1985

A087910 001 Jan 31, 1985

A088303 001 Jan 25, 1984

A084578 001

A084559 001

A086485 001

A089223
A087679
A085169
A085952
A086720
A085863
A084739
A089626
A086748

001 May 27, 1988

001 Apr 15, 1982

001

001

001

001

001

001 Oct 28, 1988

001

N019083 001 Nov 07, 1984

N019083 002 Nov 07, 1984

N019083 003 Nov 07, 1984

N019212 001 Nov 07, 1984

N019826 004 Aug 14, 1992

N019212 003 Nov 07, 1984

N019212 002 Nov 07, 1984

N019826 005 Aug 14, 1992

N018649
N018649
N018649
N018649
N018649
N018649
N018649

007
001
002
003
004
006
005

Jul
Jul
Jul
Jul
Jul
Nov
Jul

26,
26,
26,
26,
26,
13,
26,

1982

1982

1982

1982

1982

1985

1982

N019211 002 Dec 14, 1984

N019211 004 Dec 14, 1984

N019211 005 Dec 14, 1984

A089141 001 Dec 03, 1986

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-323(of 347)

DISCONTINUED DRUG PRODUCT LIST

THEOPHYLLINE

SOLUTION;ORAL

THEOLAIR

3M

THEOPHYLLINE

ROXANE

SUSPENSION;ORAL

ELIXICON

FOREST LABS

SYRUP;ORAL

ACCURBRON

SANOFI AVENTIS US

AQUAPHYLLIN

FERNDALE LABS

SLO-PHYLLIN

SANOFI AVENTIS US

THEOCLEAR-80

CENT PHARMS

THEOPHYLLINE

ALPHARMA US PHARMS

TABLET;ORAL

QUIBRON-T

MONARCH PHARMS

SLO-PHYLLIN

SANOFI AVENTIS US

THEOCLEAR-100

CENT PHARMS

THEOCLEAR-200

CENT PHARMS

THEOLAIR

MEDICIS

80MG/15ML

A086107 001

80MG/15ML

A087449 001 Sep 15, 1983

100MG/5ML

A085502 001

150MG/15ML

A088746 001 Nov 22, 1985

80MG/15ML

A087917 001 Jan 18, 1983

80MG/15ML

A085187 001

80MG/15ML

A087095 001 Mar 01, 1982

80MG/15ML

150MG/15ML

A086001 001

A086545 001

300MG

A088656 001 Aug 22, 1985

100MG

200MG

A085202 001

A085204 001

100MG

A085353 002

200MG

A085353 001

125MG

250MG

A086399 001

A086399 002

THEOPHYL-225

ORTHO MCNEIL PHARM

225MG

TABLET, CHEWABLE;ORAL

THEOPHYL

ORTHO MCNEIL PHARM

100MG

TABLET, EXTENDED RELEASE;ORAL

DURAPHYL

FOREST LABS

100MG

200MG

300MG

LABID

WARNER CHILCOTT

250MG

QUIBRON-T/SR

MONARCH PHARMS

300MG

SUSTAIRE

ROERIG

100MG

300MG

T-PHYL

PHARM RES ASSOC

200MG

THEO-DUR

SCHERING

100MG

200MG

300MG

450MG

THEOCHRON

SUN PHARM INDS INC

300MG

THEOLAIR-SR

3M

200MG

250MG

300MG

500MG

THEOPHYLLINE

ABLE

300MG

400MG

450MG

600MG

INWOOD LABS

450MG

A084726 001

A086506 001 Sep 12, 1985

A088503 001 Apr 03, 1985

A088504 001 Apr 03, 1985

A088505 001 Apr 03, 1985

A087225 001

A087563 001 Jun 21, 1983

A085665 001

A085665 002

A088253 001 Aug 17, 1983

A085328
A086998
A085328
A089131

001

001

002

001 Jun 25, 1986

A087400 002 Jan 11, 1983

A088369
A086363
A088364
A089132

001
002
001
001

Jul
Jul
Jul
Jul

16,
16,
16,
16,

1987

1987

1987

1987

A040548
A040543
A040546
A040539
A040034

001
001
001
001
001

Apr
Apr
Apr
Apr
Apr

30,
27,
30,
27,
28,

2004

2004

2004

2004

1995

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-324(of 347)

DISCONTINUED DRUG PRODUCT LIST

THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL

UNI-DUR

SCHERING
400MG

600MG

A089822 001 Jan 04, 1995

A089823 001 Jan 04, 1995

THEOPHYLLINE SODIUM GLYCINATE

ELIXIR;ORAL

SYNOPHYLATE

CENT PHARMS
TABLET;ORAL

ASBRON

NOVARTIS

EQ 165MG BASE/15ML

N006333 008

EQ 150MG BASE

A085148 001

THIABENDAZOLE

SUSPENSION;ORAL

MINTEZOL

MERCK SHARP DOHME
TABLET, CHEWABLE;ORAL

MINTEZOL

MERCK SHARP DOHME

500MG/5ML

N016097 001

500MG

N016096 001

100MG/ML

A080853 001

100MG/ML

100MG/ML

100MG/ML

200MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

200MG/ML

200MG/ML

100MG/ML

A080509
A087968
A080718
A080712
A083775
A080575
A040079
A080667
A080770
A080571
A083534
A080571
A083534
A080553

1GM/VIAL

5GM/VIAL

10GM/VIAL

N007600 003

N007600 005

N007600 009

5MG/ML

N012754 002

10MG

N013247 001

10MG

N012753 001

400MG/GM

N011679 001

EQ 25MG HCL/5ML

EQ 100MG HCL/5ML

N017923 001

N017923 002

THIAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

BETALIN S

LILLY
THIAMINE HYDROCHLORIDE

ABRAXIS PHARM
AKORN
BEL MAR
DELL LABS
HIKMA MAPLE
HOSPIRA
LUITPOLD
PARKE DAVIS
WATSON LABS

WYETH AYERST
THIAMYLAL SODIUM

INJECTABLE;INJECTION

SURITAL

PARKEDALE

THIETHYLPERAZINE MALATE

INJECTABLE;INJECTION

TORECAN

NOVARTIS
THIETHYLPERAZINE MALEATE

SUPPOSITORY;RECTAL

TORECAN

NOVARTIS
TABLET;ORAL

TORECAN

NOVARTIS
THIOPENTAL SODIUM

SUSPENSION;RECTAL

PENTOTHAL

ABBOTT
THIORIDAZINE

SUSPENSION;ORAL

MELLARIL-S

NOVARTIS

001

001 Oct 01, 1982

001

001

001

001

001 May 03, 1996

001

001

001

001

002

002

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-325(of 347)

DISCONTINUED DRUG PRODUCT LIST

THIORIDAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

MELLARIL

NOVARTIS

THIORIDAZINE HYDROCHLORIDE

ACTAVIS MID ATLANTIC

ALPHARMA US PHARMS

ANI PHARMS INC

HI TECH PHARMA

30MG/ML

100MG/ML

100MG/ML

30MG/ML

100MG/ML

30MG/ML

100MG/ML

PHARM ASSOC

30MG/ML

100MG/ML

SANDOZ

30MG/ML

100MG/ML

TEVA PHARMS

30MG/ML

WOCKHARDT

30MG/ML

100MG/ML

THIORIDAZINE HYDROCHLORIDE INTENSOL

ROXANE

30MG/ML

100MG/ML

TABLET;ORAL

MELLARIL

NOVARTIS

10MG

15MG

25MG

50MG

100MG

150MG

200MG

THIORIDAZINE HYDROCHLORIDE

ANI PHARMS INC

10MG

10MG

15MG

25MG

50MG

100MG

100MG

MUTUAL PHARM

10MG

15MG

25MG

50MG

100MG

150MG

200MG

MYLAN

10MG

25MG

50MG

100MG

PAR PHARM

10MG

15MG

25MG

50MG

100MG

150MG

200MG

ROXANE

10MG

25MG

50MG

100MG

SANDOZ

10MG

15MG

25MG

50MG

100MG

150MG

200MG

SUPERPHARM

10MG

25MG

50MG

WATSON LABS

10MG

10MG

N011808 012

N011808 018

A088229
A087766
A089603
A040125
A040126
A040187
A040213
A088307
A088308
A089602
A088258
A088227

001
001
001
001
001
001
001
001
001
001
001
001

Aug
Apr
Nov
Aug
Aug
Aug
May
Nov
Nov
Nov
Jul
Jul

23,
26,
09,
16,
16,
28,
29,
23,
23,
09,
25,
05,

1983

1983

1987

1996

1996

1997

1998

1983

1983

1987

1983

1983

A088941 001 Dec 16, 1985

A088942 001 Dec 16, 1985

N011808
N011808
N011808
N011808
N011808
N011808
N011808

003

016

006

011

009

017

015

A088270
A088493
A088271
A088272
A088194
A088273
A088456
A088375
A088461
A087264
A088370
A088379
A088737
A088738
A088332
A088333
A088334
A088335
A088351
A088352
A088336
A088322
A088480
A089764
A089765
A088663
A088664
A088665
A089048
A088131
A088132
A088133
A088134
A088135
A088136
A088137
A089103
A089104
A089105
A088412
A088476

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Apr
May
Apr
Apr
Apr
Oct
May
Nov
Nov
Nov
Nov
Nov
Sep
Oct
Jun
Jun
Jun
Nov
Dec
Dec
Dec
Dec
Dec
Feb
Feb
Mar
Mar
Mar
Feb
Aug
Aug
Aug
Aug
Nov
Sep
Sep
Jul
Jul
Jul
Sep
Nov

14,
17,
14,
14,
14,
03,
17,
18,
18,
18,
18,
16,
26,
16,
27,
27,
27,
18,
05,
05,
05,
05,
29,
09,
09,
15,
15,
15,
26,
30,
30,
30,
30,
20,
17,
17,
02,
02,
02,
12,
08,

1983

1985

1983

1983

1983

1983

1985

1983

1983

1983

1983

1983

1984

1984

1983

1983

1983

1983

1983

1983

1983

1983

1983

1988

1988

1984

1984

1984

1985

1983

1983

1983

1983

1984

1986

1986

1985

1985

1985

1983

1983

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-326(of 347)

DISCONTINUED DRUG PRODUCT LIST

THIORIDAZINE HYDROCHLORIDE

TABLET;ORAL

THIORIDAZINE HYDROCHLORIDE

WEST WARD

THIOTEPA

INJECTABLE;INJECTION

THIOPLEX

IMMUNEX

THIOTEPA

FRESENIUS KABI USA
IMMUNEX
TEVA PARENTERAL
THIOTHIXENE

CAPSULE;ORAL

NAVANE

PFIZER
THIOTHIXENE

AM THERAP

WATSON LABS

THIOTHIXENE HYDROCHLORIDE

CONCENTRATE;ORAL

NAVANE

PFIZER
THIOTHIXENE HYDROCHLORIDE

ALPHARMA US PHARMS
PACO

10MG
15MG
15MG
15MG
25MG
25MG
25MG
25MG
50MG
50MG
50MG
100MG
100MG
100MG
150MG
150MG
200MG
200MG
10MG
15MG
25MG
50MG

A088561
A088345
A088477
A088562
A088296
A088478
A088567
A088755
A088323
A088479
A088563
A088284
A088564
A088736
A088410
A088869
A088381
A088872
A088658
A088659
A088660
A088661

15MG/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N020058 001 Dec 22, 1994

15MG/VIAL
15MG/VIAL
15MG/VIAL
30MG/VIAL

A075698
N011683
A075730
A075730

20MG

N016584 005

1MG
2MG
5MG
10MG
20MG
1MG
2MG
2MG
5MG
5MG
10MG
10MG

A071884
A071885
A071886
A071887
A072200
A070600
A070601
A071626
A070602
A071627
A070603
A071628

EQ 5MG BASE/ML

N016758 001

EQ 5MG BASE/ML
EQ 1MG BASE/ML
EQ 5MG BASE/ML
TEVA
EQ 5MG BASE/ML
TEVA PHARMS
EQ 5MG BASE/ML
THIOTHIXENE HYDROCHLORIDE INTENSOL

CYCLE PHARMS LTD
EQ 5MG BASE/ML
INJECTABLE;INJECTION
NAVANE
PFIZER
EQ 2MG BASE/ML
EQ 10MG BASE/VIAL

A070969
A071917
A071939
A071184
A071554

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

May
Jul
Nov
May
Jul
Nov
May
Jul
Jul
Nov
May
Aug
May
Jul
Mar
Jun
Mar
Apr
Mar
Mar
Mar
Mar

11,
28,
08,
11,
28,
08,
11,
24,
28,
08,
11,
25,
11,
24,
05,
28,
14,
26,
26,
26,
26,
26,

1984

1983

1983

1984

1983

1983

1984

1984

1983

1983

1984

1983

1984

1984

1984

1985

1984

1985

1984

1984

1984

1984

001 Sep 20, 2001

001

001 Apr 20, 2001

002 Apr 20, 2001

001
001
001
001
001
001
001
001
001
001
001
001

001
001
001
001
001

Aug
Aug
Aug
Aug
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun

12,
12,
12,
12,
17,
05,
05,
25,
05,
25,
05,
25,

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

1987

Oct
Sep
Dec
Jun
Oct

16,
20,
16,
22,
16,

1987

1989

1988

1987

1987

A073494 001 Jun 30, 1992

N016904 001
N016904 002

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-327(of 347)

DISCONTINUED DRUG PRODUCT LIST

THYROGLOBULIN

TABLET;ORAL

PROLOID

PARKE DAVIS

THYROGLOBULIN

IMPAX LABS
THYROTROPIN

INJECTABLE;INJECTION

THYTROPAR

SANOFI AVENTIS US
TIAGABINE HYDROCHLORIDE

TABLET;ORAL

GABITRIL

CEPHALON

TICARCILLIN DISODIUM

INJECTABLE;INJECTION

TICAR

GLAXOSMITHKLINE

TICLOPIDINE HYDROCHLORIDE

TABLET;ORAL

TICLID

ROCHE PALO
TICLOPIDINE HYDROCHLORIDE

ACTAVIS ELIZABETH
MYLAN
SANDOZ
WATSON LABS
TILUDRONATE DISODIUM

TABLET;ORAL

SKELID

SANOFI AVENTIS US
TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AKORN
APOTEX INC
FOUGERA
TABLET;ORAL

BLOCADREN

MERCK

TIMOLOL MALEATE

QUANTUM PHARMICS

SANDOZ

16MG

32MG

65MG

100MG

130MG

200MG

325MG

N002245
N002245
N002245
N002245
N002245
N002245
N002245

64.8MG

A080151 001

10 IU/VIAL

N008682 001

6MG

8MG

10MG

20MG

N020646
N020646
N020646
N020646

006
007
008
004

EQ
EQ
EQ
EQ
EQ
EQ

N050497
A062690
N050497
N050497
N050497
N050497

001

001 Dec 19, 1986

002

003

004

005 Apr 04, 1984

1GM BASE/VIAL

3GM BASE/VIAL

3GM BASE/VIAL

6GM BASE/VIAL

20GM BASE/VIAL

30GM BASE/VIAL

009

005

002

008

010

007

004

Nov
Nov
Nov
Sep

29,
29,
29,
30,

2005

2005

2005

1997

125MG

250MG

N019979 001 Mar 24, 1993

N019979 002 Oct 31, 1991

250MG

250MG

250MG

250MG

250MG

250MG

A075253
A075161
A075316
A075318
A075326
A075309

EQ 200MG BASE

N020707 001 Mar 07, 1997

EQ
EQ
EQ
EQ
EQ
EQ

A074465
A074515
A075411
A075412
A074667
A074668

0.25% BASE

0.25% BASE

0.25% BASE

0.5% BASE

0.25% BASE

0.5% BASE

001
001
001
001
001
001

001
001
001
001
001
001

5MG

10MG

20MG

N018017 001

N018017 002

N018017 004

5MG

10MG

20MG

5MG

10MG

20MG

A072466
A072467
A072468
A072550
A072551
A072552

001
001
001
001
001
001

Aug
Sep
Nov
Aug
Aug
Apr

20,
13,
02,
20,
20,
26,

1999

1999

1999

1999

1999

2000

Mar
Mar
Sep
Sep
Mar
Mar

25,
25,
08,
08,
25,
25,

1997

1997

2000

2000

1997

1997

May
May
May
Apr
Apr
Apr

19,
19,
19,
13,
13,
13,

1989

1989

1989

1989

1989

1989

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-328(of 347)

DISCONTINUED DRUG PRODUCT LIST

TIMOLOL MALEATE

TABLET;ORAL

TIMOLOL MALEATE

TEVA

5MG
10MG
20MG
5MG
10MG
20MG
5MG
5MG
10MG
10MG
20MG
20MG

A072648
A072649
A072650
A072001
A072002
A072003
A072269
A072917
A072270
A072918
A072271
A072919

TINZAPARIN SODIUM

INJECTABLE;INJECTION

INNOHEP

LEO PHARMA AS

20,000 IU/ML

N020484 001 Jul 14, 2000

TIOCONAZOLE

CREAM;TOPICAL

TZ-3

PFIZER

1%

N018682 001 Feb 18, 1983

EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)

EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)

N020912 001 May 14, 1998

N020913 001 May 14, 1998

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A076283
A076283
A076371
A076371
A076321
A076321
A076282
A076282

USL PHARMA

WATSON LABS

TIROFIBAN HYDROCHLORIDE

INJECTABLE;INJECTION

AGGRASTAT

MEDICURE
TIZANIDINE HYDROCHLORIDE

TABLET;ORAL

TIZANIDINE HYDROCHLORIDE

ACTAVIS ELIZABETH
BARR
IVAX SUB TEVA PHARMS
MYLAN PHARMS INC
ZANAFLEX

ACORDA

TOBRAMYCIN

SOLUTION/DROPS;OPHTHALMIC

TOBRAMYCIN

ALCON PHARMS LTD
APOTEX INC
TOBRAMYCIN SULFATE

INJECTABLE;INJECTION

NEBCIN

LILLY

TOBRAMYCIN SULFATE

APOTHECON

HIKMA MAPLE

HOSPIRA
IGI LABS INC

2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001
001
001
001
001
001

001
002
001
002
001
002
001
002

Jun
Jun
Jun
Apr
Apr
Apr
Apr
Jul
Apr
Jul
Apr
Jul

Jul
Jul
Apr
Apr
Sep
Sep
Dec
Dec

16,
16,
16,
11,
11,
11,
11,
31,
11,
31,
11,
31,

12,
12,
09,
09,
30,
30,
16,
16,

1993

1993

1993

1989

1989

1989

1989

1991

1989

1991

1989

1991

2002

2002

2003

2003

2004

2004

2003

2003

EQ 2MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N020397 002 Feb 04, 2000

0.3%
0.3%

A063176 001 May 25, 1994

A065087 001 Feb 25, 2002

EQ
EQ
EQ
EQ
EQ

10MG BASE/ML
10MG BASE/ML
10MG BASE/ML
40MG BASE/ML
1.2GM BASE/VIAL

A062008
A062707
N050477
A062008
N050519

004

001 Apr 29, 1987

005

001

001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

10MG
40MG
40MG
10MG
10MG
40MG
40MG
10MG
40MG
10MG
40MG
40MG

A064021
A064021
A064026
A063113
A063128
A063118
A063127
A063080
A063161
A063119
A063120
A063121

001
002
001
001
001
001
001
001
001
001
001
001

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

May
May
May
Apr
Nov
Jul
Nov
Apr
May
Oct
Oct
Oct

31,
31,
31,
26,
27,
29,
27,
30,
29,
31,
31,
31,

1994

1994

1994

1991

1991

1991

1991

1991

1991

1994

1994

1994

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-329(of 347)

DISCONTINUED DRUG PRODUCT LIST

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION

TOBRAMYCIN SULFATE

EQ 40MG BASE/ML
EQ 10MG BASE/ML
EQ 40MG BASE/ML
TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA
EQ 40MG BASE/ML **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

WATSON LABS INC

TOCAINIDE HYDROCHLORIDE

TABLET;ORAL

TONOCARD

ASTRAZENECA
TOLAZAMIDE

TABLET;ORAL

TOLAZAMIDE

BARR

DURAMED PHARMS BARR

G AND W LABS INC

INTERPHARM
MUTUAL PHARM

PAR PHARM

SANDOZ

SUPERPHARM
USL PHARMA

WATSON LABS

TOLINASE

PHARMACIA AND UPJOHN

TOLAZOLINE HYDROCHLORIDE

INJECTABLE;INJECTION

PRISCOLINE

NOVARTIS
TOLBUTAMIDE

TABLET;ORAL

ORINASE

PHARMACIA AND UPJOHN
TOLBUTAMIDE

ALRA
ASCOT
BARR
DAVA PHARMS INC

A063122 001 Oct 31, 1994

A062945 001 Aug 09, 1989

A062945 002 Aug 09, 1989

A063116 001 May 18, 1992

400MG
600MG

N018257 001 Nov 09, 1984

N018257 002 Nov 09, 1984

100MG
250MG
500MG
100MG
250MG
500MG
100MG
250MG
500MG
250MG
500MG
100MG
250MG
500MG
100MG
250MG
500MG
100MG
250MG
500MG
250MG
500MG
100MG
250MG
500MG
100MG
100MG
250MG
250MG
500MG
500MG

A070162
A070163
A070164
A070165
A070166
A070167
N018894
N018894
N018894
A071270
A071271
A071357
A071358
A071359
A070159
A070160
A070161
A071633
A070289
A070290
A070763
A070764
A071355
A070168
A070169
A070242
A070513
A070243
A070514
A070244
A070515

100MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

250MG
500MG

N015500 002

N015500 004

N015500 005

25MG/ML

N006403 005 Feb 22, 1985

250MG
500MG

N010670 002

N010670 001

500MG
500MG
500MG
500MG

A086141
A087541
A087121
A086926

001
001
001
001
001
001
001
002
003
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jan
Jan
Jan
Jan
Jan
Jan
Nov
Nov
Nov
Sep
Sep
Jul
Jul
Jul
Jan
Jan
Jan
Dec
Mar
Mar
Jun
Jun
Jan
Apr
Apr
Aug
Jan
Aug
Jan
Aug
Jan

14,
14,
14,
10,
10,
10,
02,
02,
02,
23,
23,
16,
16,
16,
06,
06,
06,
09,
13,
13,
16,
16,
11,
02,
02,
01,
09,
01,
09,
01,
09,

1986

1986

1986

1986

1986

1986

1984

1984

1984

1986

1986

1987

1987

1987

1986

1986

1986

1987

1986

1986

1986

1986

1988

1986

1986

1986

1986

1986

1986

1986

1986

001

001 Mar 01, 1983

001

001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-330(of 347)

DISCONTINUED DRUG PRODUCT LIST

TOLBUTAMIDE

TABLET;ORAL

TOLBUTAMIDE

IVAX PHARMS
PARKE DAVIS
PUREPAC PHARM
SANDOZ

500MG
500MG
500MG
500MG
500MG
500MG
500MG
250MG
500MG
500MG
500MG

A087093
A086047
A088950
A086574
N012678
A088893
A087876
A089110
A086109
A087318
A089111

TOLBUTAMIDE SODIUM

INJECTABLE;INJECTION

ORINASE DIAGNOSTIC

PHARMACIA AND UPJOHN

EQ 1GM BASE/VIAL

N012095 001

TOLCAPONE

TABLET;ORAL

TASMAR

VALEANT PHARMS LLC

200MG

N020697 002 Jan 29, 1998

EQ 400MG BASE

N018084 001

EQ
EQ
EQ
EQ
EQ

A073308
A073392
A073311
A073462
A073519

SUPERPHARM
VANGARD
WATSON LABS

TOLMETIN SODIUM

CAPSULE;ORAL

TOLECTIN DS

ORTHO MCNEIL JANSSEN
TOLMETIN SODIUM

ACTAVIS ELIZABETH
IVAX SUB TEVA PHARMS
MUTUAL PHARM
SANDOZ
TEVA
TABLET;ORAL

TOLECTIN

ORTHO MCNEIL JANSSEN
TOLECTIN 600

ORTHO MCNEIL JANSSEN
TOLMETIN SODIUM

ACTAVIS ELIZABETH
G AND W LABS INC
SANDOZ
TOLVAPTAN

TABLET;ORAL

SAMSCA

OTSUKA AMERICA PHARM
TOPIRAMATE

CAPSULE;ORAL

TOPAMAX SPRINKLE

JANSSEN PHARMS
TOPIRAMATE

BARR
SANDOZ
TABLET;ORAL

TOPAMAX

JANSSEN PHARMS
TOPIRAMATE

BARR

PLIVA HRVATSKA DOO

ROXANE

400MG
400MG
400MG
400MG
400MG

BASE
BASE
BASE
BASE
BASE

001

001

001
001

001

001
001
001
001

001

001

001
001
001
001
001

Jun 17, 1985

Nov 19, 1984

Apr 20, 1982

May 29, 1987

May 29, 1987

Jan
Jan
Nov
Apr
May

24,
24,
27,
30,
29,

1992

1992

1991

1992

1992

EQ 200MG BASE

N017628 001

EQ 600MG BASE

N017628 002 Mar 08, 1989

EQ
EQ
EQ
EQ
EQ

A073527
A074399
A074729
A073588
A074002

600MG
600MG
600MG
200MG
600MG

BASE
BASE
BASE
BASE
BASE

001
001
001
001
001

Jun
Mar
Feb
Jul
Sep

30,
28,
27,
31,
27,

1992

1996

1997

1992

1993

60MG

N022275 003 May 19, 2009

50MG

N020844 003 Oct 26, 1998

15MG
25MG
15MG
25MG

A076448
A076448
A079206
A079206

300MG
400MG

N020505 003 Dec 24, 1996

N020505 006 Dec 24, 1996

25MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG

A076315
A076315
A076315
A077905
A077905
A077905
A077905
A076306
A076306

001
002
001
002

001
002
003
001
002
003
004
001
002

Apr
Apr
Oct
Oct

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

15,
15,
14,
14,

27,
27,
27,
30,
30,
30,
30,
27,
27,

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

2009

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-331(of 347)

DISCONTINUED DRUG PRODUCT LIST

TOPIRAMATE

TABLET;ORAL

TOPIRAMATE

WATSON LABS

WOCKHARDT USA

TOPIRAMATE

HIKMA PHARMS

TOPOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

TOPOTECAN HYDROCHLORIDE

FRESENIUS KABI ONCOL
SOLUTION;INTRAVENOUS

TOPOTECAN

SANDOZ INC

TORSEMIDE

INJECTABLE;INJECTION

DEMADEX

ROCHE
TORSEMIDE

EUROHLTH INTL SARL
LUITPOLD

100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG

A076306
A076306
A077643
A077643
A077643
A077643
A090353
A090353
A090353
A090353

003
004
001
002
003
004
001
002
003
004

Mar
Mar
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep

27,
27,
27,
27,
27,
27,
01,
01,
01,
01,

2009

2009

2009

2009

2009

2009

2010

2010

2010

2010

25MG
50MG
100MG
200MG

A091185
A091185
A091185
A091185

001
002
003
004

Nov
Nov
Nov
Nov

25,
25,
25,
25,

2013

2013

2013

2013

EQ 4MG BASE/VIAL

A091376 001 Nov 29, 2010

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

EQ 3MG BASE/3ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

N200199 001 Feb 25, 2011

N200199 002 Feb 25, 2011

N200199 003 Feb 25, 2011

50MG/5ML (10MG/ML)
20MG/2ML (10MG/ML)

N020137 002 Aug 23, 1993

N020137 001 Aug 23, 1993

20MG/2ML
50MG/5ML
20MG/2ML
50MG/5ML

A078007
A078007
A090656
A090656

001
002
001
002

Jun
Jun
Apr
Apr

11,
11,
21,
21,

2008

2008

2010

2010

A075960
A075974
A075963
A075968
A075962

001
001
001
001
001

Jun
Jul
Jul
Jun
Jun

19,
12,
03,
25,
24,

2002

2002

2002

2002

2002

TRAMADOL HYDROCHLORIDE

TABLET;ORAL

TRAMADOL HYDROCHLORIDE

ACTAVIS ELIZABETH
50MG
ASTA
50MG
IVAX SUB TEVA PHARMS
50MG
SANDOZ
50MG
WATSON LABS
50MG
ULTRAM

JANSSEN PHARMS
100MG
TABLET, EXTENDED RELEASE;ORAL

RYZOLT

PURDUE PHARMA
100MG
200MG
300MG
TABLET, ORALLY DISINTEGRATING;ORAL

RYBIX ODT

SHIONOGI INC
50MG
TRANDOLAPRIL

TABLET;ORAL

TRANDOLAPRIL

CIPLA

COREPHARMA

DR REDDYS LABS LTD

1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG

(10MG/ML)
(10MG/ML)
(10MG/ML)
(10MG/ML)

N020281 001 Mar 03, 1995

N021745 001 Dec 30, 2008

N021745 002 Dec 30, 2008

N021745 003 Dec 30, 2008

N021693 001 May 05, 2005

A077307
A077307
A077307
A077256
A077256
A077256
A078493
A078493
A078493

002
001
003
001
002
003
001
002
003

Jun
Jun
Jun
Jun
Jun
Jun
Aug
Aug
Aug

12,
12,
12,
12,
12,
12,
25,
25,
25,

2007

2007

2007

2007

2007

2007

2008

2008

2008

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6-332(of 347)

DISCONTINUED DRUG PRODUCT LIST

TRANEXAMIC ACID

TABLET;ORAL

CYKLOKAPRON

PHARMACIA AND UPJOHN
TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC

IZBA

ALCON LABS INC
TRAVATAN

ALCON PHARMS LTD
TRAZODONE HYDROCHLORIDE

TABLET;ORAL

DESYREL

PRAGMA PHARMS LLC

TRAZODONE HYDROCHLORIDE

AM THERAP
MYLAN
QUANTUM PHARMICS
SANDOZ
TEVA
USL PHARMA
WATSON LABS

500MG

N019280 001 Dec 30, 1986

0.003%

N204822 001 May 15, 2014

0.004%

N021257 001 Mar 16, 2001

50MG
100MG
150MG
300MG

N018207
N018207
N018207
N018207

001

002

003 Mar 25, 1985

004 Nov 07, 1988

50MG
100MG
50MG
100MG
100MG
50MG
100MG
150MG
50MG
100MG
50MG
50MG
100MG
100MG

A071139
A071140
A071405
A071406
A070921
A072484
A072483
A074357
A070491
A070492
A070857
A071112
A070858
A071113

001
001
001
001
001
001
001
001
001
001
001
001
001
001

TRIALODINE

QUANTUM PHARMICS
50MG
TABLET, EXTENDED RELEASE;ORAL

OLEPTRO

ANGELINI PHARMA
150MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

300MG **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

TRETINOIN

CAPSULE;ORAL

VESANOID

ROCHE
SOLUTION;TOPICAL

TRETINOIN

TEVA PHARMS
WOCKHARDT
SWAB;TOPICAL

RETIN-A

VALEANT INTL
TRIAMCINOLONE

TABLET;ORAL

ARISTOCORT

ASTELLAS

KENACORT

DELCOR ASSET CORP

TRIAMCINOLONE

BARR

Oct
Oct
Feb
Feb
Dec
Apr
Apr
Apr
Apr
Apr
Oct
Nov
Oct
Nov

29,
29,
27,
27,
01,
30,
30,
30,
29,
29,
10,
17,
10,
17,

1986

1986

1991

1991

1986

1990

1990

1997

1987

1987

1986

1986

1986

1986

A070942 001 Dec 01, 1986

N022411 001 Feb 02, 2010

N022411 002 Feb 02, 2010

10MG

N020438 001 Nov 22, 1995

0.05%
0.05%

A074873 001 Jun 19, 1998

A075260 001 Jan 25, 1999

0.05%

N016921 002

1MG
2MG
4MG
8MG
16MG

N011161
N011161
N011161
N011161
N011161

009

004

007

011

010

1MG
2MG
4MG
8MG

N011283
N011283
N011283
N011283

003

008

006

010

2MG
2MG

A084286 001

A084318 001

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6-333(of 347)

DISCONTINUED DRUG PRODUCT LIST

TRIAMCINOLONE

TABLET;ORAL

TRIAMCINOLONE

IMPAX LABS
IVAX SUB TEVA PHARMS
MYLAN
PUREPAC PHARM
ROXANE

SANDOZ
TEVA
WATSON LABS
TRIAMCINOLONE ACETONIDE

AEROSOL, METERED;INHALATION

AZMACORT

ABBVIE
AEROSOL, METERED;NASAL

NASACORT

SANOFI AVENTIS US
CREAM;TOPICAL

ARISTOCORT

ASTELLAS

ARISTOCORT A

ASTELLAS

FLUTEX

IVAX PHARMS

KENALOG

DELCOR ASSET CORP

KENALOG-H

DELCOR ASSET CORP
TRIACET

TEVA

TRIACORT

SOLVAY
TRIAMCINOLONE ACETONIDE

ACTAVIS MID ATLANTIC
ALPHARMA US PHARMS
AMBIX
MORTON GROVE

PHARMADERM

PHARMAFAIR

4MG
4MG
8MG
8MG
4MG
4MG
2MG
2MG
4MG
2MG
4MG
8MG
4MG
4MG
4MG
4MG

A084267
A084319
A084268
A084320
A084340
A083750
A084406
A084020
A084020
A084708
A084709
A084707
A085601
A084775
A084270
A085834

001

001

001

001

001

001

001

002

003

001

001

001

001

001

001

001

0.1MG/INH

N018117 001 Apr 23, 1982

0.055MG/INH

N019798 001 Jul 11, 1991

0.025%
0.1%
0.5%

A083017 003

A083016 004

A083015 002

0.025%
0.025%
0.1%
0.1%
0.5%
0.5%

A083017
A088818
A083016
A088819
A083015
A088820

0.025%
0.1%
0.5%

A085539 001

A085539 002

A085539 003

0.025% **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

0.1% **Federal Register determination
that product was not discontinued or

withdrawn for safety or efficacy

reasons**

0.5%

N011601 003

A083943 001

0.1%

A086240 001

0.025%
0.1%
0.5%

A084908 001

A084908 002

A084908 003

0.1%

A087113 001

0.1%
0.025%
0.025%
0.025%
0.1%
0.5%
0.025%
0.1%
0.5%
0.025%
0.1%
0.5%

A087798
A087797
A087932
A088094
A088095
A088096
A087990
A087991
A087992
A087921
A087912
A087922

004

001 Oct 16, 1984

005

001 Oct 16, 1984

003

001 Oct 16, 1984

N011601 006

001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jun
May
Sep
Sep
Sep
Jul
Jul
Jul
Aug
Aug
Aug

04,
07,
09,
01,
01,
01,
07,
07,
07,
10,
10,
10,

1982

1982

1983

1983

1983

1983

1983

1983

1983

1982

1982

1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-334(of 347)

DISCONTINUED DRUG PRODUCT LIST

TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

TRIAMCINOLONE ACETONIDE

TARO

TOPIDERM

TRIATEX

IVAX PHARMS

TRYMEX

SAVAGE LABS

0.025%
0.025%
0.1%
0.5%
0.025%
0.1%
0.5%

A040038
A086277
A086276
A086275
A089274
A089275
A089276

0.025%
0.1%
0.5%

A087430 001 Nov 01, 1988

A087429 001 Nov 01, 1988

A087428 001 Nov 01, 1988

0.025%
0.1%
0.5%

A088196 001 Mar 25, 1983

A088197 001 Mar 25, 1983

A088198 001 Mar 25, 1983

GEL;TOPICAL

ARISTOGEL

ASTELLAS
0.1%
INJECTABLE;INJECTION

TRIAMCINOLONE ACETONIDE

PARNELL
3MG/ML
SANDOZ
10MG/ML
SANDOZ CANADA INC
40MG/ML
WATSON LABS
40MG/ML
INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL

TRIVARIS

ALLERGAN
8MG/0.1ML (8MG/0.1ML)
LOTION;TOPICAL

KENALOG

DELCOR ASSET CORP
0.025%
0.025%
0.1%
0.1%
TRIAMCINOLONE ACETONIDE

ALPHARMA US PHARMS
0.025%
0.1%
OINTMENT;TOPICAL

ARISTOCORT

ASTELLAS
0.1%
0.5%
ARISTOCORT A

ASTELLAS
0.1%
0.1%
0.5%
0.5%
FLUTEX

IVAX PHARMS
0.025%
0.1%
0.5%
KENALOG

DELCOR ASSET CORP
0.5%
TRIAMCINOLONE ACETONIDE

ACTAVIS MID ATLANTIC
0.1%
ALPHARMA US PHARMS
0.5%
MORTON GROVE
0.025%
0.1%
0.5%
PHARMADERM
0.025%
0.1%
TARO
0.025%
0.025%
0.1%
0.5%
TRYMEX

SAVAGE LABS
0.025%
0.1%
PASTE;DENTAL

KENALOG IN ORABASE

DELCOR ASSET CORP
0.1%

001
001

001

001

001
001
001

Oct 26, 1994

Feb 21, 1989

Feb 21, 1989

Feb 21, 1989

A083380 001

N019503
A090166
A090164
A085825

001 Oct 16, 1987

001 May 27, 2009

001 Jun 01, 2009

001

N022220 001 Jun 16, 2008

A084343
N011602
A084343
N011602

001

003

002

001

A087191 001 Sep 08, 1982

A087192 001 Sep 08, 1982

A080750 004

A080745 002

A080750
A088780
A080745
A088781

003

001 Oct 01, 1984

003

001 Oct 05, 1984

A087375 001 Nov 01, 1988

A087377 001 Nov 01, 1988

A087376 001 Nov 01, 1988

A083944 001

A087799
A089913
A088090
A088091
A088092
A088692
A088690
A040040
A040374
A087902
A040386

001
001
001
001
001
001
001
001
001
001
001

Jun
Dec
Sep
Sep
Sep
Aug
Aug
Sep
Jun
Dec
Jun

07,
23,
01,
01,
01,
02,
02,
30,
05,
27,
05,

1982

1988

1983

1983

1983

1984

1984

1994

2001

1982

2001

A088693 001 Aug 02, 1984

A088691 001 Aug 02, 1984

N012097 001

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6-335(of 347)

DISCONTINUED DRUG PRODUCT LIST

TRIAMCINOLONE ACETONIDE

PASTE;DENTAL

ORALONE

TARO
SPRAY, METERED;NASAL

ALLERNAZE

LUPIN ATLANTIS
NASACORT HFA

SANOFI AVENTIS US
TRIAMCINOLONE DIACETATE

INJECTABLE;INJECTION

ARISTOCORT

SANDOZ

TRIAMCINOLONE DIACETATE

AKORN
WATSON LABS
SYRUP;ORAL

ARISTOCORT

ASTELLAS
KENACORT

DELCOR ASSET CORP
TRIAZOLAM

TABLET;ORAL

HALCION

PHARMACIA AND UPJOHN
TRIAZOLAM

WATSON LABS
TRICHLORMETHIAZIDE

TABLET;ORAL

METAHYDRIN

SANOFI AVENTIS US
NAQUA

SCHERING
TRICHLOREX

LANNETT
TRICHLORMAS

MAST MM
TRICHLORMETHIAZIDE

IMPAX LABS
PAR PHARM
SANDOZ
TG UNITED LABS
WATSON LABS

TRICLOFOS SODIUM

SOLUTION;ORAL

TRICLOS

SANOFI AVENTIS US
TABLET;ORAL

TRICLOS

SANOFI AVENTIS US

0.1%

A071383 001
Jul 06, 1987

0.05MG/SPRAY

N020120 001
Feb 04, 2000

0.055MG/SPRAY

N020784 001
Apr 07, 2004

25MG/ML

40MG/ML **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N011685 003

N012802 001

25MG/ML

40MG/ML

40MG/ML

40MG/ML

A085122
A086394
A084072
A085529

2MG/5ML

N011960 004

EQ 4MG BASE/5ML

N012515 001

0.5MG

N017892 002
Nov 15, 1982

0.125MG

0.25MG

A074445 001
Oct 20, 1995

A074445 002
Oct 20, 1995

2MG

4MG

N012594 001
Jun 16, 1988

N012594 002
Jun 16, 1988

2MG

4MG

N012265 001

N012265 002

4MG

4MG

A083436 001

A085630 001

4MG

A086259 001

4MG

2MG

4MG

4MG

4MG

2MG

2MG

4MG

4MG

4MG

A083967
A087007
A087005
A086171
A085568
A083847
A086458
A083462
A083855
A085962

1.5GM/15ML

N016830 001

750MG

N016809 002

001

001

001

001

001

001

001

001

001

001

001

001

001

001

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DISCONTINUED DRUG PRODUCT LIST

TRIDIHEXETHYL CHLORIDE

INJECTABLE;INJECTION

PATHILON

LEDERLE

TABLET;ORAL

PATHILON

LEDERLE

10MG/ML

N009729 001

25MG

N009489 005

TRIFLUOPERAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

STELAZINE

GLAXOSMITHKLINE

EQ
TRIFLUOPERAZINE HYDROCHLORIDE

SANDOZ

EQ
WOCKHARDT

EQ
INJECTABLE;INJECTION

STELAZINE

GLAXOSMITHKLINE

EQ
TABLET;ORAL

STELAZINE

GLAXOSMITHKLINE

EQ
EQ
EQ
EQ
TRIFLUOPERAZINE HYDROCHLORIDE

DURAMED PHARMS BARR

EQ
EQ
EQ
EQ
IVAX PHARMS

EQ
EQ
EQ
EQ
SANDOZ

EQ
EQ
EQ
EQ
WATSON LABS

EQ
EQ
EQ
EQ
TRIFLUPROMAZINE

SUSPENSION;ORAL

VESPRIN

APOTHECON

TRIFLUPROMAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

VESPRIN

APOTHECON

TABLET;ORAL

VESPRIN

BRISTOL MYERS SQUIBB

10MG BASE/ML

N011552 006

10MG BASE/ML

10MG BASE/ML

A085787 001 Apr 15, 1982

A088143 001 Jul 26, 1983

2MG BASE/ML

N011552 005

1MG BASE

2MG BASE

5MG BASE

10MG BASE

N011552
N011552
N011552
N011552

001

002

003

004

1MG BASE

2MG BASE

5MG BASE

10MG BASE

1MG BASE

2MG BASE

5MG BASE

10MG BASE

1MG BASE

2MG BASE

5MG BASE

10MG BASE

1MG BASE

2MG BASE

5MG BASE

10MG BASE

A088967
A088968
A088969
A088970
A087612
A087613
A087328
A087614
A040153
A040153
A040153
A040153
A085975
A085976
A085973
A088710

001
001
001
001
001
001
001
001
001
002
003
004
001
001
001
001

EQ 50MG HCL/5ML

N011491 004

3MG/ML

10MG/ML

20MG/ML

N011325 005

N011325 004

N011325 001

10MG

25MG

50MG

N011123 001

N011123 002

N011123 003

TRIHEXYPHENIDYL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

ARTANE

LEDERLE
5MG

5MG

ELIXIR;ORAL

ARTANE

LEDERLE
2MG/5ML

TRIHEXYPHENIDYL HYDROCHLORIDE

PHARM VENTURES
2MG/5ML

TABLET;ORAL

ARTANE

LEDERLE
2MG

5MG

Apr
Apr
Apr
Apr
Nov
Nov
Nov
Nov
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun

23,
23,
23,
23,
19,
19,
19,
19,
25,
25,
25,
25,
23,
23,
23,
23,

1985

1985

1985

1985

1982

1982

1982

1982

1996

1996

1996

1996

1988

1988

1988

1988

N006773 010

N012947 001

N006773 009

A089514 001 Apr 07, 1989

N006773 005

N006773 003

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6-337(of 347)

DISCONTINUED DRUG PRODUCT LIST

TRIHEXYPHENIDYL HYDROCHLORIDE

TABLET;ORAL

TREMIN

SCHERING

2MG

5MG

TRIHEXYPHENIDYL HYDROCHLORIDE

HIKMA PHARMS LLC
2MG

5MG

NYLOS
5MG

VANGARD
2MG

WATSON LABS
2MG

2MG

5MG

5MG

TRILOSTANE

CAPSULE;ORAL

MODRASTANE

BIOENVISION

30MG

60MG

TRIMEPRAZINE TARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

TEMARIL

ALLERGAN HERBERT

EQ
SYRUP;ORAL

TEMARIL

ALLERGAN HERBERT

EQ
TRIMEPRAZINE TARTRATE

ALPHARMA US PHARMS

EQ
MORTON GROVE

EQ
TABLET;ORAL

TEMARIL

ALLERGAN HERBERT

EQ
TRIMETHADIONE

CAPSULE;ORAL

TRIDIONE

ABBVIE

SOLUTION;ORAL

TRIDIONE

ABBVIE

TRIMETHAPHAN CAMSYLATE

INJECTABLE;INJECTION

ARFONAD

ROCHE

TRIMETHOPRIM

MUTUAL PHARM

TEVA

TRIMPEX

ROCHE

TRIMPEX 200

ROCHE

A040337
A040337
A085622
A088035
A040184
A085117
A040184
A085105

002
001
001

001
001
001

002
001

Feb 16, 2000

Feb 16, 2000

Jul 30, 1982

Feb 06, 1998

Feb 06, 1998

N018719 002 Dec 31, 1984

N018719 001 Dec 31, 1984

5MG BASE

N011316 004

2.5MG BASE/5ML

N011316 003

2.5MG BASE/5ML

2.5MG BASE/5ML

A085015 001 Feb 18, 1982

A088285 001 Apr 11, 1985

2.5MG BASE

N011316 001

300MG

N005856 005

200MG/5ML

N005856 002

50MG/ML

N008983 001

TRIMETHOBENZAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

TRIMETHOBENZAMIDE HYDROCHLORIDE

HOSPIRA

100MG/ML

SMITH AND NEPHEW

100MG/ML

100MG/ML

SOLOPAK

100MG/ML

WATSON LABS

100MG/ML

100MG/ML

TRIMETHOPRIM

TABLET;ORAL

PROLOPRIM

MONARCH PHARMS

A080381 001

A080381 003

A088804
A088960
A089043
A089094
A086577
A087939

001
001
001
001
001
001

Apr
Apr
Apr
Apr
Oct
Dec

03,
04,
04,
04,
19,
28,

1987

1986

1986

1986

1982

1982

100MG

200MG

N017943 001

N017943 003 Jul 14, 1982

100MG

200MG

200MG

A070494 001 Jan 22, 1986

A070495 001 Sep 24, 1986

A071259 001 Jun 18, 1987

100MG

N017952 001

200MG

N017952 002 Nov 09, 1982

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6-338(of 347)

DISCONTINUED DRUG PRODUCT LIST

TRIMETHOPRIM HYDROCHLORIDE

SOLUTION;ORAL

PRIMSOL

FSC

EQ 25MG BASE/5ML

A074374 001 Jun 23, 1995

EQ 25MG BASE/VIAL

EQ 200MG BASE/VIAL

N020326 001 Dec 17, 1993

N020326 002 Jul 31, 1998

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

A071283 001 Dec 08, 1987

A071284 001 Dec 08, 1987

A071285 001 Dec 08, 1987

TRIOXSALEN

TABLET;ORAL

TRISORALEN

VALEANT PHARM INTL

5MG

N012697 001

TRIPELENNAMINE CITRATE

ELIXIR;ORAL

PBZ

NOVARTIS

EQ 25MG HCL/5ML

N005914 004

TRIMETREXATE GLUCURONATE

INJECTABLE;INJECTION

NEUTREXIN

MEDIMMUNE ONCOLOGY

TRIMIPRAMINE MALEATE

CAPSULE;ORAL

TRIMIPRAMINE MALEATE

USL PHARMA

TRIPELENNAMINE HYDROCHLORIDE

TABLET;ORAL

PBZ

NOVARTIS

25MG

50MG

TRIPELENNAMINE HYDROCHLORIDE

ANABOLIC

50MG

BARR

50MG

HEATHER

50MG

IMPAX LABS

50MG

LANNETT

50MG

NYLOS

50MG

PARKE DAVIS

25MG

50MG

WATSON LABS

50MG

50MG

50MG

TABLET, EXTENDED RELEASE;ORAL

PBZ-SR

NOVARTIS

50MG

100MG

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)

CREAM;VAGINAL

GYNE-SULF

G AND W LABS

2.86%;3.42%;3.7%

SULTRIN

ORTHO MCNEIL PHARM

2.86%;3.42%;3.7%

TRIPLE SULFA

ALPHARMA US PHARMS

2.86%;3.42%;3.7%

FOUGERA

2.86%;3.42%;3.7%

PERRIGO NEW YORK

2.86%;3.42%;3.7%

TRYSUL

SAVAGE LABS

2.86%;3.42%;3.7%

VAGILIA

G AND W LABS INC

3.42%;3.42%;3.42%

TABLET;VAGINAL

SULTRIN

ORTHO MCNEIL PHARM

143.75MG;172.5MG;184MG

TRIPLE SULFA

FOUGERA

172.5MG;172.5MG;172.5MG

PHARMADERM

172.5MG;172.5MG;172.5MG

A083149 001

N005914 002

A083037
A080744
A083989
A080785
A083557
A085412
A083625
A083626
A080713
A080790
A085188

001

001

001

001

001

001

001

001

001

001

001

N010533 002

N010533 001

A088607 001 Jun 09, 1986

N005794 001

A087864 001 Sep 01, 1982

A086424 001

A087285 001 Nov 15, 1982

A087887 001 Jul 23, 1982

A088821 001 Nov 09, 1987

N005794 002

A088463 001 Jan 03, 1985

A088462 001 Jan 03, 1985

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

TRIPROLIDINE HYDROCHLORIDE

SYRUP;ORAL

ACTIDIL

GLAXOSMITHKLINE

MYIDYL

USL PHARMA

TRIPROLIDINE HYDROCHLORIDE

ALPHARMA US PHARMS

HALSEY

PHARM ASSOC

TABLET;ORAL

ACTIDIL

GLAXOSMITHKLINE

TRIPROLIDINE HYDROCHLORIDE

VITARINE

WATSON LABS

1.25MG/5ML

N011496 002 Jul 01, 1983

1.25MG/5ML

A087963 001 Jan 18, 1983

1.25MG/5ML

1.25MG/5ML

1.25MG/5ML

A085940 001

A088735 001 Jan 17, 1985

A087514 001 Feb 10, 1982

2.5MG

N011110 002 Jul 01, 1983

2.5MG

2.5MG

A085610 001

A085094 001

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

SUSPENSION;ORAL

LANTRISUL

LANNETT

167MG/5ML;167MG/5ML;167MG/5ML

NEOTRIZINE

LILLY

167MG/5ML;167MG/5ML;167MG/5ML

SULFALOID

FOREST PHARMS

167MG/5ML;167MG/5ML;167MG/5ML

SULFOSE

WYETH AYERST

167MG/5ML;167MG/5ML;167MG/5ML

TERFONYL

BRISTOL MYERS SQUIBB
167MG/5ML;167MG/5ML;167MG/5ML

TRIPLE SULFA

ALPHARMA US PHARMS

167MG/ML;167MG/ML;167MG/ML

TRIPLE SULFAS

LEDERLE

167MG/5ML;167MG/5ML;167MG/5ML

TABLET;ORAL

NEOTRIZINE

LILLY

167MG;167MG;167MG

SULFA-TRIPLE #2

IMPAX LABS

167MG;167MG;167MG

SULFALOID

FOREST PHARMS

167MG;167MG;167MG

SULFOSE

WYETH AYERST

167MG;167MG;167MG

TERFONYL

BRISTOL MYERS SQUIBB
167MG;167MG;167MG

TRIPLE SULFA

PUREPAC PHARM

167MG;167MG;167MG

TRIPLE SULFAS

LEDERLE

167MG;167MG;167MG

TRIPLE SULFOID

PAL PAK

167MG;167MG;167MG

TROGLITAZONE

TABLET;ORAL

PRELAY

SANKYO

REZULIN

PFIZER PHARMS

A080123 002

N006317 012

A080100 001

A080013 002

N006904 002

A080280 001

N006920 003

N006317 011

A080079 001

A080099 001

A080013 001

N006904 001

A080086 001

N006920 002

A080094 001

200MG

300MG

400MG

N020719 001 Jan 29, 1997

N020719 003 Aug 04, 1997

N020719 002 Jan 29, 1997

200MG

300MG

400MG

N020720 001 Jan 29, 1997

N020720 003 Aug 04, 1997

N020720 002 Jan 29, 1997

TROLAMINE POLYPEPTIDE OLEATE CONDENSATE

SOLUTION/DROPS;OTIC

CERUMENEX

PHARM RES ASSOC
10%

TROLEANDOMYCIN

CAPSULE;ORAL

TAO

PFIZER
SUSPENSION;ORAL

TAO

PFIZER

6-339(of 347)

N011340 002

EQ 250MG BASE

N050336 002

EQ 125MG BASE/5ML

N050332 001

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-340(of 347)

DISCONTINUED DRUG PRODUCT LIST

TROPICAMIDE

SOLUTION/DROPS;OPHTHALMIC

MYDRIACYL

ALCON

MYDRIAFAIR

PHARMAFAIR

TROPICAMIDE

AKORN

ALCON PHARMS LTD

MIZA PHARMS USA

WATSON LABS

0.5%

1%

N012111 002

N012111 004

0.5%

1%

A088274 001
Sep 16, 1983

A088230 001
Sep 16, 1983

1%

1%

0.5%

1%

0.5%

A088447
A089172
A087636
A087637
A089171

TROSPIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

SANCTURA XR

ALLERGAN

60MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

TABLET;ORAL

SANCTURA

ALLERGAN

20MG **Federal Register determination

that product was not discontinued or

withdrawn for safety or efficacy

reasons**

TROVAFLOXACIN MESYLATE

TABLET;ORAL

TROVAN

PFIZER

001

001

001

001

001

Aug
Dec
Jul
Aug
Dec

28,
28,
30,
09,
28,

1985

1990

1982

1982

1990

N022103 001
Aug 03, 2007

N021595 001
May 28, 2004

EQ 100MG BASE

EQ 200MG BASE

N020759 001
Dec 18, 1997

N020759 002
Dec 18, 1997

TUBOCURARINE CHLORIDE

INJECTABLE;INJECTION

TUBOCURARINE CHLORIDE

BRISTOL MYERS SQUIBB

HOSPIRA

LILLY

3MG/ML

3MG/ML

3MG/ML

N005657 001

N006095 001

N006325 001

TYROPANOATE SODIUM

CAPSULE;ORAL

BILOPAQUE

GE HEALTHCARE

750MG

N013731 001

URACIL MUSTARD

CAPSULE;ORAL

URACIL MUSTARD

SHIRE

1MG

N012892 001

40GM/VIAL

N017698 001

40GM/VIAL

N012154 001

UREA

INJECTABLE;INJECTION

STERILE UREA

HOSPIRA

UREAPHIL

HOSPIRA

UREA C-13

FOR SOLUTION;ORAL

BREATHTEK UBT FOR H-PYLORI

OTSUKA AMERICA

EQ 75MG/POUCH

HELICOSOL

METABOLIC SOLUTIONS

125MG/VIAL

MERETEK UBT KIT (W/ PRANACTIN)

OTSUKA AMERICA
125MG/VIAL

PYLORI-CHEK BREATH TEST

DXS DEVICES
100MG/VIAL

UROFOLLITROPIN

INJECTABLE;INTRAMUSCULAR

METRODIN

SERONO

75 IU/AMP

150 IU/AMP

N020586 002
May 10, 2001

N021092 001
Dec 17, 1999

N020586 001
Sep 17, 1996

N020900 001
Feb 04, 1999

N019415 002
Sep 18, 1986

N019415 003
Sep 18, 1986

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6-341(of 347)

DISCONTINUED DRUG PRODUCT LIST

UROFOLLITROPIN

INJECTABLE;SUBCUTANEOUS

FERTINEX

SERONO
UROKINASE

INJECTABLE;INJECTION

KINLYTIC

MICROBIX BIOSYSTEMS

URSODIOL

CAPSULE;ORAL

ACTIGALL

ACTAVIS LABS UT INC
TABLET;ORAL

URSODIOL

TEVA PHARMS USA
VALDECOXIB

TABLET;ORAL

BEXTRA

GD SEARLE

75 IU/AMP
150 IU/AMP

N019415 005 Aug 23, 1996

N019415 004 Aug 23, 1996

5,000 IU/VIAL
9,000 IU/VIAL
250,000 IU/VIAL

N021846 003

N021846 002

N021846 001

150MG

N019594 001 Dec 31, 1987

250MG
500MG

A079184 001 May 13, 2009

A079184 002 May 13, 2009

10MG
20MG

N021341 002 Nov 16, 2001

N021341 003 Nov 16, 2001

VALPROIC ACID

CAPSULE;ORAL

VALPROIC ACID

PAR PHARM
250MG
SCHERER RP
250MG
USL PHARMA
250MG
CAPSULE, DELAYED RELEASE;ORAL

STAVZOR

BANNER LIFE SCIENCES 125MG
250MG
500MG
SYRUP;ORAL

VALPROIC ACID

APOTEX INC
250MG/5ML
VALSARTAN

CAPSULE;ORAL

DIOVAN

NOVARTIS
VANCOMYCIN HYDROCHLORIDE

FOR SOLUTION;ORAL

VANCOCIN HYDROCHLORIDE

ANI PHARMS INC
VANCOLED

LEDERLE
INJECTABLE;INJECTION

VANCOCIN HYDROCHLORIDE

ANI PHARMS INC

A070431 001 Feb 28, 1986

A070195 001 Jul 02, 1987

A070631 001 Jun 11, 1987

N022152 001 Jul 29, 2008

N022152 002 Jul 29, 2008

N022152 003 Jul 29, 2008

A077105 001 Jul 29, 2005

80MG
160MG

N020665 001 Dec 23, 1996

N020665 002 Dec 23, 1996

EQ 250MG BASE/5ML
EQ 500MG BASE/6ML

A061667 002 Jul 13, 1983

A061667 001

EQ 250MG BASE/5ML
EQ 500MG BASE/6ML

A063321 002 Oct 15, 1993

A063321 003 Oct 15, 1993

EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL **Federal Register
determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

EQ 10GM BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

A060180
A062476
A062716
A062812

001

001 Mar 15, 1984

001 Mar 13, 1987

001 Nov 17, 1987

A060180
A062476
A062716
A062812

002
002
002
002

Mar
Mar
Mar
Nov

21,
21,
13,
17,

1986

1986

1987

1987

A062812 003 Nov 17, 1987

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6-342(of 347)

DISCONTINUED DRUG PRODUCT LIST

VANCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

VANCOCIN HYDROCHLORIDE

efficacy reasons**

VANCOLED

EUROHLTH INTL SARL

VANCOMYCIN HYDROCHLORIDE

HIKMA MAPLE
VANCOR

PHARMACIA AND UPJOHN
VASOPRESSIN TANNATE

INJECTABLE;INJECTION

PITRESSIN TANNATE

PARKE DAVIS
VECURONIUM BROMIDE

INJECTABLE;INJECTION

NORCURON

ORGANON USA INC
VECURONIUM BROMIDE

HIKMA MAPLE
HOSPIRA
WATSON LABS
VELAGLUCERASE ALFA

POWDER;IV (INFUSION)

VPRIV

SHIRE HUMAN GENETIC

EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
5GM BASE/VIAL
10GM BASE/VIAL

A062682
A062682
A062682
A062682
A062682

001
002
003
004
005

Jul
Mar
May
May
May

22,
30,
11,
11,
11,

1986

1988

1988

1988

1988

EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL

A062879 001 Aug 02, 1988

A062879 002 Aug 02, 1988

EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL

A062956 001 Aug 01, 1988

A062956 002 Aug 01, 1988

5PRESSOR UNITS/ML

N003402 001

10MG/VIAL
20MG/VIAL

N018776 002 Apr 30, 1984

N018776 003 Jan 03, 1992

10MG/VIAL
20MG/VIAL
4MG/VIAL
10MG/VIAL
20MG/VIAL

A075218
A075218
A075558
A074334
A074334

200 UNITS/VIAL

N022575 002 Feb 26, 2010

VENLAFAXINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

EFFEXOR XR

WYETH PHARMS INC
EQ 100MG BASE
TABLET;ORAL

EFFEXOR

WYETH PHARMS INC
EQ 12.5MG BASE **Federal Register
determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

EQ 25MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

EQ 37.5MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

EQ 50MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

EQ 75MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

EQ 100MG BASE **Federal Register

determination that product was not

discontinued or withdrawn for safety

efficacy reasons**

VENLAFAXINE HYDROCHLORIDE

PLIVA HRVATSKA DOO
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
SANDOZ
EQ 25MG BASE
EQ 37.5MG BASE

001
002
001
001
002

Aug
Aug
Sep
Aug
Aug

23,
23,
11,
31,
31,

1999

1999

2001

1995

1995

N020699 003 Oct 20, 1997

N020151 001 Dec 28, 1993

or

N020151 002 Dec 28, 1993

or

N020151 006 Dec 28, 1993

or

N020151 003 Dec 28, 1993

or

N020151 004 Dec 28, 1993

or

N020151 005 Dec 28, 1993

or

A078517
A078517
A078517
A078517
A078517
A077515
A077515

001
002
003
004
005
001
002

Jun
Jun
Jun
Jun
Jun
Jun
Jun

13,
13,
13,
13,
13,
13,
13,

2008

2008

2008

2008

2008

2008

2008

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6-343(of 347)

DISCONTINUED DRUG PRODUCT LIST

VENLAFAXINE HYDROCHLORIDE

TABLET;ORAL

VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE

INJECTABLE;INJECTION

CALAN

EXELA PHARMA SCS LLC
GD SEARLE LLC
ISOPTIN

MT ADAMS
VERAPAMIL HYDROCHLORIDE

ABRAXIS PHARM
BEDFORD
HOSPIRA

INTL MEDICATION
LUITPOLD
MARSAM PHARMS LLC
SMITH AND NEPHEW
SOLOPAK
TABLET;ORAL

CALAN

GD SEARLE LLC
ISOPTIN

MT ADAMS

EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE

A077515 003 Jun 13, 2008

A077515 004 Jun 13, 2008

A077515 005 Jun 13, 2008

2.5MG/ML
2.5MG/ML

N018925 001 Mar 30, 1984

N019038 001 Mar 30, 1984

2.5MG/ML

N018485 001

2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML

A070348
A072888
A070577
A070739
A070740
A070451
A070225
A070617
A072233
A073485
A070696
A070697
A070695

160MG

N018817 004 Feb 23, 1988

40MG
80MG
120MG

N018593 003 Nov 23, 1987

N018593 001 Mar 08, 1982

N018593 002 Mar 08, 1982

VERAPAMIL HYDROCHLORIDE

ACTAVIS ELIZABETH

80MG
120MG
MUTUAL PHARM
80MG
80MG
120MG
120MG
PLIVA
40MG
80MG
120MG
SANDOZ
40MG
80MG
120MG
WARNER CHILCOTT
80MG
120MG
WATSON LABS
40MG
40MG
80MG
80MG
120MG
120MG
TABLET, EXTENDED RELEASE;ORAL

VERAPAMIL HYDROCHLORIDE

PLIVA
240MG
VERATRUM VIRIDE ROOT

TABLET;ORAL

VERTAVIS

MEDPOINTE PHARM HLC
VIDARABINE

INJECTABLE;INJECTION

VIRA-A

PARKEDALE
OINTMENT;OPHTHALMIC

VIRA-A

PARKEDALE

A071019
A070468
A070482
A071489
A070483
A071489
A072751
A072124
A072125
A073168
A071423
A071424
A070340
A070341
A072799
A072923
A070855
A071366
A070856
A071367

001
001
001
001
001
001
001
001
001
001
001
001
001

001
001
001
002
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

May
Jul
Feb
May
May
Dec
Nov
Nov
Feb
Sep
Jul
Jul
Jul

Sep
Sep
Sep
Jan
Sep
Jan
Feb
Jan
Jan
Jul
May
May
Sep
Sep
Apr
Jun
Sep
Oct
Sep
Oct

01,
28,
02,
06,
06,
16,
12,
12,
26,
27,
31,
31,
31,

24,
24,
24,
13,
24,
13,
23,
26,
26,
31,
24,
25,
24,
24,
28,
29,
24,
01,
24,
01,

1986

1995

1987

1987

1987

1985

1985

1985

1993

1993

1987

1987

1987

1986

1986

1986

1988

1986

1988

1996

1989

1989

1992

1988

1988

1986

1986

1989

1993

1986

1986

1986

1986

A072922 001 Mar 01, 1996

130CSR UNIT

N005691 002

EQ 187.4MG BASE/ML

N050523 001

3%

N050486 001

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6-344(of 347)

DISCONTINUED DRUG PRODUCT LIST

VINBLASTINE SULFATE

INJECTABLE;INJECTION

VELBAN

LILLY

VINBLASTINE SULFATE

ABRAXIS PHARM

HOSPIRA

VINCRISTINE SULFATE

INJECTABLE;INJECTION

ONCOVIN

LILLY

VINCASAR PFS

TEVA PARENTERAL

VINCREX

BRISTOL MYERS SQUIBB

VINCRISTINE SULFATE

ABIC

ABRAXIS PHARM

FRESENIUS KABI USA

HOSPIRA

VINORELBINE TARTRATE

INJECTABLE;INJECTION

VINORELBINE TARTRATE

EBEWE PHARMA

VIOMYCIN SULFATE

INJECTABLE;INJECTION

VIOCIN SULFATE

PFIZER

VITAMIN A

CAPSULE;ORAL

AQUASOL A

ASTRAZENECA

VITAMIN A

BANNER PHARMACAPS

CHASE CHEM

EVERYLIFE

IMPAX LABS

WEST WARD

VITAMIN A PALMITATE

CAPSULE;ORAL

AFAXIN

STERLING WINTHROP

ALPHALIN

LILLY

DEL-VI-A

DEL RAY LABS

VI-DOM-A

BAYER PHARMS

VITAMIN A

BANNER PHARMACAPS

BRISTOL MYERS SQUIBB

CHASE CHEM

ELKINS SINN

EVERYLIFE

IMPAX LABS

IVAX SUB TEVA PHARMS

MK LABS

WEST WARD

10MG/VIAL

N012665 001

10MG/VIAL

10MG/VIAL

A089011 001 Nov 18, 1985

A089565 001 Aug 18, 1987

1MG/VIAL

1MG/ML

5MG/VIAL

N014103 001

N014103 003 Mar 07, 1984

N014103 002

1MG/ML

A071426 001 Jul 17, 1987

5MG/VIAL

A070867 001 Jul 12, 1988

1MG/ML

1MG/ML

1MG/ML

1MG/ML

1MG/VIAL

2MG/VIAL

5MG/VIAL

A070873
A070411
A076296
A076401
A071559
A071560
A071561

EQ 10MG BASE/ML

A078408 001 Feb 13, 2008

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

A061086 001

A061086 002

25,000USP UNITS

50,000USP UNITS

A083080 002

A083080 001

50,000USP UNITS

50,000 IU

50,000 IU

50,000USP UNITS

50,000USP UNITS

A083973
A083351
A083134
A080952
A080985

EQ 50,000 UNITS BASE

A083187 001

EQ 50,000 UNITS BASE

A080883 001

EQ 50,000 UNITS BASE

A080830 001

EQ 50,000 UNITS BASE

A080972 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A080702
A080860
A080746
A083207
A085479
A080943
A083114
A080953
A080955
A083035
A083190
A083457
A083457
A080967

50,000
50,000
50,000
50,000
50,000
50,000
50,000
50,000
50,000
50,000
50,000
25,000
50,000
50,000

UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

BASE

001
001
001
001
001
001
001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

002

001

001

Feb
Sep
Dec
Oct
Apr
Apr
Apr

19,
10,
20,
28,
11,
11,
11,

1987

1986

2002

2003

1988

1988

1988

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6-345(of 347)

DISCONTINUED DRUG PRODUCT LIST

VITAMIN A PALMITATE

CAPSULE;ORAL

VITAMIN A

WHARTON LABS
VITAMIN A PALMITATE

ARCUM
BANNER PHARMACAPS
VITAMIN A SOLUBILIZED

TEVA
INJECTABLE;INJECTION

VITAMIN A PALMITATE

BEL MAR
WARFARIN POTASSIUM

TABLET;ORAL

ATHROMBIN-K

PHARM RES ASSOC

WARFARIN SODIUM

INJECTABLE;INJECTION

COUMADIN

BRISTOL MYERS SQUIBB

TABLET;ORAL

ATHROMBIN

PHARM RES ASSOC

PANWARFIN

ABBOTT

WARFARIN SODIUM

SANDOZ

USL PHARMA

WATSON LABS

XENON XE-127

GAS;INHALATION

XENON XE 127

MALLINCKRODT
XENON XE-133

GAS;INHALATION

XENON XE 133

GE HEALTHCARE

GEN ELECTRIC
MALLINKRODT NUCLEAR

EQ 50,000 UNITS BASE

A083665 001

EQ
EQ
EQ
EQ

A083311
A083321
A083948
A083981

50,000
50,000
50,000
50,000

UNITS
UNITS
UNITS
UNITS

BASE

BASE

BASE

BASE

001

001

001

001

EQ 50,000 UNITS BASE

A080921 001

EQ 50,000 UNITS BASE/ML

A080819 001

2MG

5MG

10MG

25MG

N011771
N011771
N011771
N011771

5MG/VIAL

50MG/VIAL

75MG/VIAL

N009218 024 Feb 07, 1995

N009218 020

N009218 012

5MG

10MG

25MG

N011771 003

N011771 002

N011771 001

2MG

2.5MG

5MG

7.5MG

10MG

N017020
N017020
N017020
N017020
N017020

001

002

003

004

005

1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

2MG

2.5MG

5MG

2MG

2.5MG

5MG

7.5MG

10MG

A040196
A040196
A040196
A040196
A040196
A040196
A040196
A040196
A040196
A088719
A088720
A088721
A086123
A086120
A086119
A086118
A086122

001
002
003
008
004
005
009
006
007
001
001
001
001
001
001
001
001

5mCi/VIAL

10mCi/VIAL

N018536 001 Oct 01, 1982

N018536 002 Oct 01, 1982

1 CI/AMP

10mCi/VIAL

20mCi/VIAL

5-100 CI/CYLINDER

0.25-5 CI/AMP

10mCi/VIAL

N017256
N017687
N017687
N017550
N017550
N018327

007

004

005

006

Sep
Sep
Sep
Jul
Sep
Sep
Jul
Sep
Sep
Jun
Aug
Jul
Aug
Aug
Aug
Aug
Aug

30,
30,
30,
26,
30,
30,
26,
30,
30,
27,
06,
02,
17,
17,
17,
17,
17,

1997

1997

1997

2000

1997

1997

2000

1997

1997

1985

1985

1985

1982

1982

1982

1982

1982

002

002

003

001

003

001 Mar 09, 1982

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST

6-346(of 347)

XENON XE-133

GAS;INHALATION

XENON XE 133

20mCi/VIAL
XENON XE 133-V.S.S.

GE HEALTHCARE
10mCi/VIAL
INJECTABLE;INJECTION

XENON XE 133

GE HEALTHCARE
1.3-1.7 CI/AMP
LANTHEUS MEDCL
6.3mCi/ML
SOLUTION;INHALATION, INJECTION

XENEISOL

MALLINCKRODT
18-25mCi/AMP
XYLOSE

POWDER;ORAL

XYLO-PFAN

SAVAGE LABS
XYLOSE

LYNE

N018327 002 Mar 09, 1982

N017687 001

N017256 001

N017283 001

N017262 002

25GM/BOT

N017605 001

25GM/BOT

N018856 001 Mar 26, 1987

0.375MG
0.75MG

N020199 001 Jun 19, 1992

N020199 002 Jun 19, 1992

5MG
10MG

A078095 001 Jun 06, 2008

A078095 002 Jun 06, 2008

200MCG/2ML (100MCG/ML)

N021060 003 Dec 28, 2004

10MG/ML

A204538 001 Nov 26, 2013

200MG
300MG

N020518 001 Dec 19, 1995

N020518 002 Oct 04, 1996

60MG
100MG
300MG

N022294 001 Jul 23, 2009

N200732 001 Feb 23, 2011

A077327 001 Sep 19, 2005

ZILEUTON

TABLET;ORAL

ZYFLO

CHIESI USA INC

300MG

N020471 001 Dec 09, 1996

ZINC SULFATE

INJECTABLE;INJECTION

ZINC SULFATE

ABRAXIS PHARM

EQ 1MG ZINC/ML

N019229 002 May 05, 1987

ZIPRASIDONE HYDROCHLORIDE

SUSPENSION;ORAL

GEODON

PFIZER INC

EQ 10MG BASE/ML

N021483 001 Mar 29, 2006

EQ 4MG BASE/VIAL **Federal Register

determination that product was not

discontinued or withdrawn for safety or

efficacy reasons**

N021223 001 Aug 20, 2001

ZALCITABINE

TABLET;ORAL

HIVID

ROCHE
ZALEPLON

CAPSULE;ORAL

ZALEPLON

SANDOZ
ZICONOTIDE ACETATE

INJECTABLE;INTRATHECAL

PRIALT

JAZZ PHARMS INTL
ZIDOVUDINE

INJECTABLE;INJECTION

ZIDOVUDINE

LIAONING CHENGDA
TABLET;ORAL

RETROVIR

VIIV HLTHCARE
ZIDOVUDINE

AUROBINDO PHARMA
MATRIX LABS LTD
RANBAXY LABS LTD

ZOLEDRONIC ACID

INJECTABLE;IV (INFUSION)

ZOMETA

NOVARTIS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

6-347(of 347)

DISCONTINUED DRUG PRODUCT LIST

ZOLPIDEM TARTRATE

TABLET;ORAL

ZOLPIDEM TARTRATE

DR REDDYS LABS LTD

5MG

10MG

HIKMA
5MG

10MG

MUTUAL PHARMA
5MG

10MG

MYLAN PHARMS INC
5MG

10MG

SYNTHON PHARMS
5MG

10MG

VIVIMED LABS
5MG

10MG

WATSON LABS
5MG

10MG

TABLET, ORALLY DISINTEGRATING;ORAL

TOVALT ODT

BIOVAIL LABS INTL
5MG

10MG

ZONISAMIDE

CAPSULE;ORAL

ZONISAMIDE

ANI PHARMS INC

COREPHARMA

DR REDDYS LABS LTD

MUTUAL PHARM

ROXANE

SANDOZ

WATSON LABS

25MG

25MG

50MG

50MG

100MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

25MG

50MG

100MG

A077985
A077985
A078129
A078129
A077288
A077288
A078016
A078016
A077540
A077540
A076062
A076062
A077773
A077773

001
002
001
002
001
002
001
002
001
002
001
002
001
002

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

23,
23,
30,
30,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,

2007

2007

2008

2008

2007

2007

2007

2007

2007

2007

2007

2007

2007

2007

N021412 001 Apr 25, 2007

N021412 002 Apr 25, 2007

A077639
A077641
A077639
A077641
A077639
A077641
A077876
A077876
A077876
A077645
A077645
A077645
A077635
A077635
A077635
A077648
A077648
A077648
A077644
A077644
A077644
A077650
A077650
A077650

001
003
002
002
003
001
001
002
003
002
003
001
001
002
003
001
002
003
001
002
003
001
002
003

Dec
Dec
Dec
Dec
Dec
Dec
Feb
Feb
Feb
Sep
Sep
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Apr
Apr
Apr

22,
22,
22,
22,
22,
22,
21,
21,
21,
29,
29,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
20,
20,
20,

2005

2005

2005

2005

2005

2005

2007

2007

2007

2006

2006

2005

2005

2005

2005

2005

2005

2005

2005

2005

2005

2006

2006

2006

36TH EDITION - 2016 - APPROVED DRUG PRODUCTS LIST

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of List of Orphan Designations and Approvals is available at:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm

7-1

36TH EDITION - 2016 - APPROVED DRUG PRODUCTS LIST

8-1

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY

ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION
ACETAMINOPHEN;ASPIRIN;BUTALBITAL
CAPSULE OR TABLET; ORAL
160-165MG;160-165MG;50MG
325MG;325MG;50MG

ASPIRIN;CAFFEINE;CARISOPRODOL;
CODEINE PHOSPHATE
TABLET; ORAL
160MG;32MG;200MG;16MG

ACETAMINOPHEN;ASPIRIN;BUTALBITAL;
CAFFEINE
CAPSULE OR TABLET; ORAL
160-165MG;160-165MG;50MG;40MG
325MG;325MG;50MG;40MG

ASPIRIN;CARISOPRODOL
TABLET; ORAL
325MG;200MG

ACETAMINOPHEN;BUTALBITAL
CAPSULE OR TABLET; ORAL
325MG;50MG
ACETAMINOPHEN;BUTALBITAL;CAFFEINE
CAPSULE OR TABLET; ORAL
325MG;50MG;40MG
AMINOPHYLLINE
TABLET; ORAL
100MG;200MG
ASPIRIN;BUTALBITAL
CAPSULE OR TABLET; ORAL
325MG;50MG
650MG;50MG
ASPIRIN;BUTALBITAL;CAFFEINE
CAPSULE OR TABLET; ORAL
325MG;50MG;40MG
650MG;50MG;40MG
ASPIRIN;CAFFEINE;CARISOPRODOL
TABLET; ORAL
160MG;32MG;200MG

ASPIRIN;CARISOPRODOL;
CODEINE PHOSPHATE
TABLET; ORAL
325MG;200MG;16MG
ASPIRIN;MEPROBAMATE
TABLET; ORAL
325MG;200MG
ASPIRIN;METHOCARBAMOL
TABLET; ORAL
325MG;400MG
CHLOROTHIAZIDE
TABLET; ORAL
250MG
HYDROXYZINE HYDROCHLORIDE
TABLET; ORAL
10MG;25MG;
50MG;100MG
PREDNISONE
TABLET; ORAL
1MG;2.5MG;5MG;10MG;
20MG;25MG;50MG

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

8-MOP,

PRODUCT NAME INDEX

**

**

**

**

METHOXSALEN

A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE

A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE

ABACAVIR SULFATE, ABACAVIR SULFATE

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE

ABELCET, AMPHOTERICIN B

ABILIFY, ARIPIPRAZOLE

ABILIFY MAINTENA KIT, ARIPIPRAZOLE

ABLAVAR, GADOFOSVESET TRISODIUM

ABRAXANE, PACLITAXEL

ABREVA, DOCOSANOL
(OTC)

ABSORICA, ISOTRETINOIN

ABSTRAL, FENTANYL CITRATE

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ACANYA, BENZOYL PEROXIDE

ACARBOSE, ACARBOSE

ACCOLATE, ZAFIRLUKAST

ACCUNEB, ALBUTEROL SULFATE

ACCUPRIL, QUINAPRIL HYDROCHLORIDE

ACCURETIC, HYDROCHLOROTHIAZIDE

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

ACEON, PERINDOPRIL ERBUMINE

ACEPHEN, ACETAMINOPHEN
(OTC)

ACETADOTE, ACETYLCYSTEINE

ACETAMINOPHEN, ACETAMINOPHEN
(OTC)

ACETAMINOPHEN, ACETAMINOPHEN

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN

(OTC)

ACETASOL HC, ACETIC ACID, GLACIAL

ACETAZOLAMIDE, ACETAZOLAMIDE

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ACETAZOLAMIDE SODIUM , ACETAZOLAMIDE SODIUM

ACETIC ACID, ACETIC ACID, GLACIAL

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL

ACETYLCYSTEINE, ACETYLCYSTEINE

ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE

ACIPHEX, RABEPRAZOLE SODIUM

ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM

ACITRETIN, ACITRETIN

ACTHREL, CORTICORELIN OVINE TRIFLUTATE

ACTICLATE, DOXYCYCLINE HYCLATE

ACTIGALL, URSODIOL

ACTIQ, FENTANYL CITRATE

ACTIVELLA, ESTRADIOL

ACTONEL, RISEDRONATE SODIUM

ACTOPLUS MET, METFORMIN HYDROCHLORIDE

ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE

ACTOS, PIOGLITAZONE HYDROCHLORIDE

ACULAR, KETOROLAC TROMETHAMINE

ACULAR LS, KETOROLAC TROMETHAMINE

ACUVAIL, KETOROLAC TROMETHAMINE

ACYCLOVIR, ACYCLOVIR

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ACZONE, DAPSONE

ADAGEN, PEGADEMASE BOVINE

ADALAT CC, NIFEDIPINE

ADAPALENE, ADAPALENE

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

ADASUVE, LOXAPINE

ADCIRCA, TADALAFIL

ADDERALL XR 10, AMPHETAMINE ASPARTATE

A - 1

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ADDERALL XR 15, AMPHETAMINE ASPARTATE

ADDERALL XR 20, AMPHETAMINE ASPARTATE

ADDERALL XR 25, AMPHETAMINE ASPARTATE

ADDERALL XR 30, AMPHETAMINE ASPARTATE

ADDERALL XR 5, AMPHETAMINE ASPARTATE

ADDYI, FLIBANSERIN

ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL

ADEMPAS, RIOCIGUAT

ADENOCARD, ADENOSINE

ADENOSCAN, ADENOSINE

ADENOSINE, ADENOSINE

ADIPEX-P, PHENTERMINE HYDROCHLORIDE

ADRENACLICK, EPINEPHRINE

ADRENALIN, EPINEPHRINE

ADREVIEW, IOBENGUANE SULFATE I-123

ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE

ADVAIR HFA, FLUTICASONE PROPIONATE

ADVICOR, LOVASTATIN

ADVIL, IBUPROFEN
(OTC)

ADVIL, IBUPROFEN SODIUM

(OTC)

ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE

ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE
(OTC)

ADVIL COLD AND SINUS, IBUPROFEN

(OTC)

ADVIL CONGESTION RELIEF, IBUPROFEN

(OTC)

ADVIL LIQUI-GELS, IBUPROFEN

(OTC)

ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN

(OTC)

ADVIL PM, DIPHENHYDRAMINE CITRATE

(OTC)

ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE

(OTC)

AEROSPAN HFA, FLUNISOLIDE

AFEDITAB CR, NIFEDIPINE

AFINITOR, EVEROLIMUS

AFINITOR DISPERZ, EVEROLIMUS

AFREZZA, INSULIN RECOMBINANT HUMAN

AFRINOL, PSEUDOEPHEDRINE SULFATE

(OTC)

AGGRASTAT, TIROFIBAN HYDROCHLORIDE

AGGRENOX, ASPIRIN

AGRYLIN, ANAGRELIDE HYDROCHLORIDE

AK-FLUOR 10%, FLUORESCEIN SODIUM

AK-FLUOR 25%, FLUORESCEIN SODIUM

AKBETA, LEVOBUNOLOL HYDROCHLORIDE

AKNE-MYCIN, ERYTHROMYCIN

AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE

AKTEN, LIDOCAINE HYDROCHLORIDE

AKTOB, TOBRAMYCIN

AKYNZEO, NETUPITANT

ALA-CORT, HYDROCORTISONE

ALA-SCALP, HYDROCORTISONE

ALAVERT, LORATADINE
(OTC)

ALAWAY, KETOTIFEN FUMARATE

(OTC)

ALBENZA, ALBENDAZOLE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALCAINE, PROPARACAINE HYDROCHLORIDE

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

ALDACTAZIDE, HYDROCHLOROTHIAZIDE

ALDACTONE, SPIRONOLACTONE

ALDARA, IMIQUIMOD

ALECENSA, ALECTINIB HYDROCHLORIDE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALEVE, NAPROXEN SODIUM

(OTC)

ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE

(OTC)

ALEVE-D SINUS & COLD, NAPROXEN SODIUM

(OTC)

ALFENTA, ALFENTANIL HYDROCHLORIDE

(OTC)

A - 2

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ALFENTANIL, ALFENTANIL HYDROCHLORIDE

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALIMTA, PEMETREXED DISODIUM

ALINIA, NITAZOXANIDE

ALKERAN, MELPHALAN

ALKERAN, MELPHALAN HYDROCHLORIDE

ALLEGRA, FEXOFENADINE HYDROCHLORIDE

ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE

(OTC)

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE

(OTC)

ALLI, ORLISTAT
(OTC)

ALLOPURINOL, ALLOPURINOL

ALLOPURINOL SODIUM, ALLOPURINOL SODIUM

ALLZITAL, ACETAMINOPHEN

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

ALOCRIL, NEDOCROMIL SODIUM

ALOMIDE, LODOXAMIDE TROMETHAMINE

ALOPRIM, ALLOPURINOL SODIUM

ALORA, ESTRADIOL

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

ALOXI, PALONOSETRON HYDROCHLORIDE

ALPHAGAN P, BRIMONIDINE TARTRATE

ALPRAZOLAM, ALPRAZOLAM

ALPROSTADIL, ALPROSTADIL

ALREX, LOTEPREDNOL ETABONATE

ALSUMA, SUMATRIPTAN SUCCINATE

ALTABAX, RETAPAMULIN

ALTACE, RAMIPRIL

ALTAVERA, ETHINYL ESTRADIOL

ALTOPREV, LOVASTATIN

ALVESCO, CICLESONIDE

ALYACEN 1/35, ETHINYL ESTRADIOL

ALYACEN 7/7/7, ETHINYL ESTRADIOL

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMARYL, GLIMEPIRIDE

AMBIEN, ZOLPIDEM TARTRATE

AMBIEN CR, ZOLPIDEM TARTRATE

AMBISOME, AMPHOTERICIN B

AMCINONIDE, AMCINONIDE

AMERGE, NARATRIPTAN HYDROCHLORIDE

AMICAR, AMINOCAPROIC ACID

AMIDATE, ETOMIDATE

AMIFOSTINE, AMIFOSTINE

AMIKACIN SULFATE, AMIKACIN SULFATE

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

AMINO ACIDS, AMINO ACIDS

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE

AMINOCAPROIC, AMINOCAPROIC ACID

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID

AMINOPHYLLINE, AMINOPHYLLINE

AMINOSYN 10%, AMINO ACIDS

AMINOSYN 10% (PH6), AMINO ACIDS

AMINOSYN 3.5%, AMINO ACIDS

AMINOSYN 3.5% M, AMINO ACIDS

AMINOSYN 5%, AMINO ACIDS

AMINOSYN 7%, AMINO ACIDS

AMINOSYN 7% (PH6), AMINO ACIDS

AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN 8.5%, AMINO ACIDS

AMINOSYN 8.5% (PH6), AMINO ACIDS

AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN II 10%, AMINO ACIDS

A - 3

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 7%, AMINO ACIDS

AMINOSYN II 8.5%, AMINO ACIDS

AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN-HBC 7%, AMINO ACIDS

AMINOSYN-HF 8%, AMINO ACIDS

AMINOSYN-PF 10%, AMINO ACIDS

AMINOSYN-PF 7%, AMINO ACIDS

AMINOSYN-RF 5.2%, AMINO ACIDS

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMITIZA, LUBIPROSTONE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

AMMONIA N 13, AMMONIA N-13

AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE

AMMONIUM LACTATE, AMMONIUM LACTATE

AMMONUL, SODIUM BENZOATE

AMNESTEEM, ISOTRETINOIN

AMOXAPINE, AMOXAPINE

AMOXICILLIN, AMOXICILLIN

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN PEDIATRIC, AMOXICILLIN

AMOXIL, AMOXICILLIN

AMPHADASE, HYALURONIDASE

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF, AMPHETAMINE

AMPHOTEC, AMPHOTERICIN B

AMPHOTERICIN B, AMPHOTERICIN B

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

AMPYRA, DALFAMPRIDINE

AMRINONE LACTATE, INAMRINONE LACTATE

AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE

AMYVID, FLORBETAPIR F-18

AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT

AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT

ANADROL-50, OXYMETHOLONE

ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ANAPROX, NAPROXEN SODIUM

ANAPROX DS, NAPROXEN SODIUM

ANASTROZOLE, ANASTROZOLE

ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

ANCOBON, FLUCYTOSINE

ANDRODERM, TESTOSTERONE

ANDROGEL, TESTOSTERONE

ANDROID 10, METHYLTESTOSTERONE

ANDROID 25, METHYLTESTOSTERONE

ANECTINE, SUCCINYLCHOLINE CHLORIDE

ANEXSIA 5/325, ACETAMINOPHEN

ANEXSIA 7.5/325, ACETAMINOPHEN

ANGELIQ, DROSPIRENONE

ANGIOMAX, BIVALIRUDIN

ANORO ELLIPTA, UMECLIDINIUM BROMIDE

ANTABUSE, DISULFIRAM

ANTARA (MICRONIZED), FENOFIBRATE

ANTHELIOS 20, AVOBENZONE

(OTC)

ANTHELIOS 40, AVOBENZONE

(OTC)

ANTHELIOS SX, AVOBENZONE

(OTC)

A - 4

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ANTIZOL, FOMEPIZOLE

ANUSOL HC, HYDROCORTISONE

ANZEMET, DOLASETRON MESYLATE

APIDRA, INSULIN GLULISINE RECOMBINANT

APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT

APLENZIN, BUPROPION HYDROBROMIDE

APOKYN, APOMORPHINE HYDROCHLORIDE

APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE

APREPITANT, APREPITANT

APRISO, MESALAMINE

APTENSIO XR, METHYLPHENIDATE HYDROCHLORIDE

APTIOM, ESLICARBAZEPINE ACETATE

APTIVUS, TIPRANAVIR

AQUASOL A, VITAMIN A PALMITATE

ARALEN, CHLOROQUINE PHOSPHATE

ARANELLE, ETHINYL ESTRADIOL

ARAVA, LEFLUNOMIDE

ARCAPTA NEOHALER, INDACATEROL MALEATE

ARESTIN, MINOCYCLINE HYDROCHLORIDE

ARGATROBAN, ARGATROBAN

ARGATROBAN IN 0.9% SODIUM CHLORIDE, ARGATROBAN

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

ARICEPT, DONEPEZIL HYDROCHLORIDE

ARICEPT ODT, DONEPEZIL HYDROCHLORIDE

ARIMIDEX, ANASTROZOLE

ARIPIPRAZOLE, ARIPIPRAZOLE

ARISTADA, ARIPIPRAZOLE LAUROXIL

ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE

ARIXTRA, FONDAPARINUX SODIUM

ARNUITY ELLIPTA, FLUTICASONE FUROATE

AROMASIN, EXEMESTANE

ARRANON, NELARABINE

ARTHROTEC, DICLOFENAC SODIUM

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE

ASACOL HD, MESALAMINE

ASCLERA, POLIDOCANOL

ASHLYNA, ETHINYL ESTRADIOL

ASMANEX HFA, MOMETASONE FUROATE

ASMANEX TWISTHALER, MOMETASONE FUROATE

ASPIRIN, ASPIRIN
(OTC)

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

ASTAGRAF XL, TACROLIMUS

ASTELIN, AZELASTINE HYDROCHLORIDE

ASTEPRO, AZELASTINE HYDROCHLORIDE

ASTRAMORPH PF, MORPHINE SULFATE

ATACAND, CANDESARTAN CILEXETIL

ATACAND HCT, CANDESARTAN CILEXETIL

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

ATELVIA, RISEDRONATE SODIUM

ATENOLOL, ATENOLOL

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATHENTIA NEXT, LEVONORGESTREL

(OTC)

ATIVAN, LORAZEPAM

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ATOVAQUONE, ATOVAQUONE

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRALIN, TRETINOIN

ATRIDOX, DOXYCYCLINE HYCLATE

ATRIPLA, EFAVIRENZ

ATROPEN, ATROPINE

ATROPINE SULFATE, ATROPINE SULFATE

ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE

ATROVENT, IPRATROPIUM BROMIDE

A - 5

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ATROVENT HFA, IPRATROPIUM BROMIDE

AUBAGIO, TERIFLUNOMIDE

AUGMENTIN '125', AMOXICILLIN

AUGMENTIN '200', AMOXICILLIN

AUGMENTIN '250', AMOXICILLIN

AUGMENTIN '400', AMOXICILLIN

AUGMENTIN '500', AMOXICILLIN

AUGMENTIN '875', AMOXICILLIN

AUGMENTIN ES-600, AMOXICILLIN

AUGMENTIN XR, AMOXICILLIN

AURYXIA, FERRIC CITRATE

AUVI-Q, EPINEPHRINE

AVAGARD, ALCOHOL
(OTC)

AVAGE, TAZAROTENE

AVALIDE, HYDROCHLOROTHIAZIDE

AVANDIA, ROSIGLITAZONE MALEATE

AVAPRO, IRBESARTAN

AVC, SULFANILAMIDE

AVEED, TESTOSTERONE UNDECANOATE

AVELOX, MOXIFLOXACIN HYDROCHLORIDE

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER,

AVIANE-28, ETHINYL ESTRADIOL

AVITA, TRETINOIN

AVODART, DUTASTERIDE

AVYCAZ, AVIBACTAM SODIUM

AXERT, ALMOTRIPTAN MALATE

AXID, NIZATIDINE

AXID AR, NIZATIDINE

(OTC)

AXIRON, TESTOSTERONE

AYGESTIN, NORETHINDRONE ACETATE

AZACITIDINE, AZACITIDINE

AZACTAM, AZTREONAM

AZACTAM IN PLASTIC CONTAINER, AZTREONAM

AZASAN, AZATHIOPRINE

AZASITE, AZITHROMYCIN

AZATHIOPRINE, AZATHIOPRINE

AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZELEX, AZELAIC ACID

AZILECT, RASAGILINE MESYLATE

AZITHROMYCIN, AZITHROMYCIN

AZOPT, BRINZOLAMIDE

AZOR, AMLODIPINE BESYLATE

AZTREONAM, AZTREONAM

AZULFIDINE, SULFASALAZINE

AZULFIDINE EN-TABS, SULFASALAZINE

**

MOXIFLOXACIN HYDROCHLORIDE

**

BACIIM, BACITRACIN

BACITRACIN, BACITRACIN

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN

BACLOFEN, BACLOFEN

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM

BACTRIM, SULFAMETHOXAZOLE

BACTRIM DS, SULFAMETHOXAZOLE

BACTROBAN, MUPIROCIN

BACTROBAN, MUPIROCIN CALCIUM

BAL, DIMERCAPROL

BALANCED SALT, CALCIUM CHLORIDE

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BALZIVA-28, ETHINYL ESTRADIOL

BANZEL, RUFINAMIDE

A - 6

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

BARACLUDE, ENTECAVIR

BASAGLAR, INSULIN GLARGINE

BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE

BEKYREE, DESOGESTREL

BELBUCA, BUPRENORPHINE HYDROCHLORIDE

BELEODAQ, BELINOSTAT

BELSOMRA, SUVOREXANT

BELVIQ, LORCASERIN HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENDEKA, BENDAMUSTINE HYDROCHLORIDE

BENICAR, OLMESARTAN MEDOXOMIL

BENICAR HCT, HYDROCHLOROTHIAZIDE

BENTYL, DICYCLOMINE HYDROCHLORIDE

BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE

BENZACLIN, BENZOYL PEROXIDE

BENZAMYCIN, BENZOYL PEROXIDE

BENZAMYCIN PAK, BENZOYL PEROXIDE

BENZONATATE, BENZONATATE

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BEPREVE, BEPOTASTINE BESILATE

BESIVANCE, BESIFLOXACIN HYDROCHLORIDE

BETA-VAL, BETAMETHASONE VALERATE

BETADINE, POVIDONE-IODINE

BETAGAN, LEVOBUNOLOL HYDROCHLORIDE

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

BETAPACE, SOTALOL HYDROCHLORIDE

BETAPACE AF, SOTALOL HYDROCHLORIDE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

BETHKIS, TOBRAMYCIN

BETIMOL, TIMOLOL

BETOPTIC, BETAXOLOL HYDROCHLORIDE

BETOPTIC S, BETAXOLOL HYDROCHLORIDE

BEXAROTENE, BEXAROTENE

BEYAZ, DROSPIRENONE

BIAXIN, CLARITHROMYCIN

BICALUTAMIDE, BICALUTAMIDE

BICILLIN C-R, PENICILLIN G BENZATHINE

BICILLIN C-R 900/300, PENICILLIN G BENZATHINE

BICILLIN L-A, PENICILLIN G BENZATHINE

BICNU, CARMUSTINE

BIDIL, HYDRALAZINE HYDROCHLORIDE

BILTRICIDE, PRAZIQUANTEL

BIMATOPROST, BIMATOPROST

BINOSTO, ALENDRONATE SODIUM

BIOSCRUB, CHLORHEXIDINE GLUCONATE

(OTC)

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BIVALIRUDIN, BIVALIRUDIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BLEPH-10, SULFACETAMIDE SODIUM

BLEPHAMIDE, PREDNISOLONE ACETATE

BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE

BLISOVI 24 FE, ETHINYL ESTRADIOL

BLISOVI FE 1.5/30, ETHINYL ESTRADIOL

BLISOVI FE 1/20, ETHINYL ESTRADIOL

BLOXIVERZ, NEOSTIGMINE METHYLSULFATE

BONIVA, IBANDRONATE SODIUM

BONTRIL PDM, PHENDIMETRAZINE TARTRATE

BOSULIF, BOSUTINIB MONOHYDRATE

BRAVELLE, UROFOLLITROPIN

A - 7

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 8

PRODUCT NAME INDEX

**

**

BREO ELLIPTA, FLUTICASONE FUROATE

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE

BREVIBLOC, ESMOLOL HYDROCHLORIDE

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVICON 28-DAY, ETHINYL ESTRADIOL

BREVITAL SODIUM, METHOHEXITAL SODIUM

BRIAN CARE, CHLORHEXIDINE GLUCONATE

(OTC)

BRIDION, SUGAMMADEX SODIUM

BRIELLYN, ETHINYL ESTRADIOL

BRILINTA, TICAGRELOR

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BRINTELLIX, VORTIOXETINE HYDROBROMIDE

BRISDELLE, PAROXETINE MESYLATE

BROMFED-DM, BROMPHENIRAMINE MALEATE

BROMFENAC SODIUM, BROMFENAC SODIUM

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE,

BRONCHO SALINE, SODIUM CHLORIDE

(OTC)

BROVANA, ARFORMOTEROL TARTRATE

BSS, CALCIUM CHLORIDE

BSS PLUS, CALCIUM CHLORIDE

BUDESONIDE, BUDESONIDE

BUMETANIDE, BUMETANIDE

BUMEX, BUMETANIDE

BUNAVAIL, BUPRENORPHINE HYDROCHLORIDE

BUPHENYL, SODIUM PHENYLBUTYRATE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPRENEX, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE , BUPRENORPHINE HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUSULFAN, BUSULFAN

BUSULFEX, BUSULFAN

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE, ASPIRIN

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

BUTAPAP, ACETAMINOPHEN

BUTISOL SODIUM, BUTABARBITAL SODIUM

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

BUTRANS, BUPRENORPHINE
BYDUREON, EXENATIDE SYNTHETIC
BYETTA, EXENATIDE SYNTHETIC
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
**
C-SOLVE-2, ERYTHROMYCIN
CABERGOLINE, CABERGOLINE
CADUET, AMLODIPINE BESYLATE
CAFCIT, CAFFEINE CITRATE
CAFERGOT, CAFFEINE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALAN, VERAPAMIL HYDROCHLORIDE
CALAN SR, VERAPAMIL HYDROCHLORIDE
CALCIPOTRIENE, CALCIPOTRIENE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE,

**

BETAMETHASONE DIPROPIONATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

CALCITONIN-SALMON, CALCITONIN SALMON

CALCITRIOL, CALCITRIOL

CALCIUM ACETATE, CALCIUM ACETATE

CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE

(OTC)

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM

CALDOLOR, IBUPROFEN

CAMBIA, DICLOFENAC POTASSIUM

CAMILA, NORETHINDRONE

CAMPRAL, ACAMPROSATE CALCIUM

CAMPTOSAR, IRINOTECAN HYDROCHLORIDE

CANASA, MESALAMINE

CANCIDAS, CASPOFUNGIN ACETATE

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CANTIL, MEPENZOLATE BROMIDE

CAPASTAT SULFATE, CAPREOMYCIN SULFATE

CAPECITABINE, CAPECITABINE

CAPEX, FLUOCINOLONE ACETONIDE

CAPITAL AND CODEINE, ACETAMINOPHEN

CAPITAL SOLEIL 15, AVOBENZONE

(OTC)

CAPRELSA, VANDETANIB

CAPTOPRIL, CAPTOPRIL

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

CARAC, FLUOROURACIL

CARAFATE, SUCRALFATE

CARBAGLU, CARGLUMIC ACID

CARBAMAZEPINE, CARBAMAZEPINE

CARBATROL, CARBAMAZEPINE

CARBIDOPA, CARBIDOPA

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CARBOCAINE, MEPIVACAINE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CARDENE, NICARDIPINE HYDROCHLORIDE

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82

CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT

CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CARDIZEM, DILTIAZEM HYDROCHLORIDE

CARDIZEM CD, DILTIAZEM HYDROCHLORIDE

CARDIZEM LA, DILTIAZEM HYDROCHLORIDE

CARDURA, DOXAZOSIN MESYLATE

CARDURA XL, DOXAZOSIN MESYLATE

CARISOPRODOL, CARISOPRODOL

CARISOPRODOL AND ASPIRIN, ASPIRIN

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

CARNITOR, LEVOCARNITINE

CARNITOR SF, LEVOCARNITINE

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

CARTIA XT, DILTIAZEM HYDROCHLORIDE

CARVEDILOL, CARVEDILOL

CASODEX, BICALUTAMIDE

CATAFLAM, DICLOFENAC POTASSIUM

CATAPRES, CLONIDINE HYDROCHLORIDE

CATAPRES-TTS-1, CLONIDINE

CATAPRES-TTS-2, CLONIDINE

CATAPRES-TTS-3, CLONIDINE

CAVERJECT, ALPROSTADIL

CAVERJECT IMPULSE, ALPROSTADIL

CAYSTON, AZTREONAM

A - 9

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

CEDAX, CEFTIBUTEN DIHYDRATE

CEFACLOR, CEFACLOR

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM

CEFAZOLIN IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFDINIR, CEFDINIR

CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

CEFIXIME, CEFIXIME

CEFOTAXIME, CEFOTAXIME SODIUM

CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFOTETAN, CEFOTETAN DISODIUM

CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM

CEFOXITIN, CEFOXITIN SODIUM

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM

CEFOXITIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFTAZIDIME, CEFTAZIDIME

CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME

CEFTIN, CEFUROXIME AXETIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM

CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEFUROXIME SODIUM, CEFUROXIME SODIUM

CELEBREX, CELECOXIB

CELECOXIB, CELECOXIB

CELESTONE SOLUSPAN, BETAMETHASONE ACETATE

CELEXA, CITALOPRAM HYDROBROMIDE

CELLCEPT, MYCOPHENOLATE MOFETIL

CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

CELONTIN, METHSUXIMIDE

CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A

CENTANY, MUPIROCIN

CEPHALEXIN, CEPHALEXIN

CERDELGA, ELIGLUSTAT TARTRATE

CEREBYX, FOSPHENYTOIN SODIUM

CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT

CEREZYME, IMIGLUCERASE

CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE

CERVIDIL, DINOPROSTONE

CESAMET, NABILONE

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE

CETROTIDE, CETRORELIX

CEVIMELINE, CEVIMELINE HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CHANTIX, VARENICLINE TARTRATE

CHEMET, SUCCIMER

CHENODIOL, CHENODIOL

CHG SCRUB, CHLORHEXIDINE GLUCONATE

(OTC)

CHILDREN'S ADVIL, IBUPROFEN

(OTC)

CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE

(OTC)

CHILDREN'S ADVIL COLD, IBUPROFEN

(OTC)

CHILDREN'S ADVIL-FLAVORED, IBUPROFEN

(OTC)

CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

A - 10

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CLARITIN, LORATADINE

(OTC)

CHILDREN'S ELIXSURE, IBUPROFEN

(OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

CHILDREN'S IBUPROFEN, IBUPROFEN

(OTC)

CHILDREN'S MOTRIN, IBUPROFEN

(OTC)

CHILDREN'S MOTRIN COLD, IBUPROFEN

(OTC)

CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN

CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE

(OTC)

CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE

CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

CHLOROTHIAZIDE, CHLOROTHIAZIDE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE

(OTC)

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CHLORPROPAMIDE, CHLORPROPAMIDE

CHLORTHALIDONE, CHLORTHALIDONE

CHLORZOXAZONE, CHLORZOXAZONE

CHOLAC, LACTULOSE

CHOLBAM, CHOLIC ACID

CHOLEDYL SA, OXTRIPHYLLINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT

CHOLINE C-11, CHOLINE C-11

CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE

CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC

CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE

CIALIS, TADALAFIL

CICLOPIROX, CICLOPIROX

CIDA-STAT, CHLORHEXIDINE GLUCONATE

(OTC)

CIDOFOVIR, CIDOFOVIR

CILOSTAZOL, CILOSTAZOL

CILOXAN, CIPROFLOXACIN HYDROCHLORIDE

CIMETIDINE, CIMETIDINE
(OTC)

CIMETIDINE, CIMETIDINE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CIPRO, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN HYDROCHLORIDE

CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPRODEX, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT

CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

A - 11

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 12

PRODUCT NAME INDEX

**

**

CISPLATIN, CISPLATIN

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE

CLADRIBINE, CLADRIBINE

CLAFORAN, CEFOTAXIME SODIUM

CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM

CLARAVIS, ISOTRETINOIN

CLARINEX, DESLORATADINE

CLARINEX D 24 HOUR, DESLORATADINE

CLARINEX-D 12 HOUR, DESLORATADINE

CLARITHROMYCIN, CLARITHROMYCIN

CLARITIN, LORATADINE
(OTC)

CLARITIN HIVES RELIEF, LORATADINE

(OTC)

CLARITIN HIVES RELIEF REDITAB, LORATADINE

(OTC)

CLARITIN REDITABS, LORATADINE

(OTC)

CLARITIN-D, LORATADINE
(OTC)

CLARITIN-D 24 HOUR, LORATADINE

(OTC)

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

(OTC)

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLEOCIN, CLINDAMYCIN PHOSPHATE

CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLEOCIN T, CLINDAMYCIN PHOSPHATE

CLEVIPREX, CLEVIDIPINE

CLIMARA, ESTRADIOL

CLIMARA PRO, ESTRADIOL

CLINDA-DERM, CLINDAMYCIN PHOSPHATE

CLINDAGEL, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLINDAMYCIN PHOSPHATE AND TRETINOIN, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE

CLINDESSE, CLINDAMYCIN PHOSPHATE

CLINDETS, CLINDAMYCIN PHOSPHATE

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

CLINOLIPID 20%, OLIVE OIL

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBEX, CLOBETASOL PROPIONATE

CLODERM, CLOCORTOLONE PIVALATE

CLOLAR, CLOFARABINE

CLOMID, CLOMIPHENE CITRATE

CLOMIPHENE CITRATE, CLOMIPHENE CITRATE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLONIDINE, CLONIDINE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE , CLONIDINE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CLORPRES, CHLORTHALIDONE

CLOTRIMAZOLE, CLOTRIMAZOLE
(OTC)

CLOTRIMAZOLE, CLOTRIMAZOLE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOZAPINE, CLOZAPINE

CLOZARIL, CLOZAPINE

COARTEM, ARTEMETHER

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE

CODEINE SULFATE, CODEINE SULFATE

COGENTIN, BENZTROPINE MESYLATE

COL-PROBENECID, COLCHICINE

COLAZAL, BALSALAZIDE DISODIUM

COLCRYS, COLCHICINE

COLESTID, COLESTIPOL HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE

COLGATE TOTAL, SODIUM FLUORIDE

(OTC)

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

COLOCORT, HYDROCORTISONE

COLY-MYCIN M, COLISTIMETHATE SODIUM

COLY-MYCIN S, COLISTIN SULFATE

COLYTE, POLYETHYLENE GLYCOL 3350

COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

COMBIGAN, BRIMONIDINE TARTRATE

COMBIPATCH, ESTRADIOL

COMBIVENT RESPIMAT, ALBUTEROL SULFATE

COMBIVIR, LAMIVUDINE

COMETRIQ, CABOZANTINIB S-MALATE

COMMIT, NICOTINE POLACRILEX

(OTC)

COMPLERA, EMTRICITABINE

COMPRO, PROCHLORPERAZINE

COMTAN, ENTACAPONE

CONCERTA, METHYLPHENIDATE HYDROCHLORIDE

CONDYLOX, PODOFILOX

CONRAY, IOTHALAMATE MEGLUMINE

CONRAY 30, IOTHALAMATE MEGLUMINE

CONRAY 43, IOTHALAMATE MEGLUMINE

CONSTILAC, LACTULOSE

CONSTULOSE, LACTULOSE

CONTRAVE, BUPROPION HYDROCHLORIDE

CONZIP, TRAMADOL HYDROCHLORIDE

COPAXONE, GLATIRAMER ACETATE

COPEGUS, RIBAVIRIN

CORDARONE, AMIODARONE HYDROCHLORIDE

CORDRAN, FLURANDRENOLIDE

CORDRAN SP, FLURANDRENOLIDE

COREG, CARVEDILOL

COREG CR, CARVEDILOL PHOSPHATE

CORGARD, NADOLOL

CORLANOR, IVABRADINE HYDROCHLORIDE

CORLOPAM, FENOLDOPAM MESYLATE

CORMAX, CLOBETASOL PROPIONATE

A - 13

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

CORTEF, HYDROCORTISONE

CORTENEMA, HYDROCORTISONE

CORTIFOAM, HYDROCORTISONE ACETATE

CORTISONE ACETATE, CORTISONE ACETATE

CORTISPORIN, BACITRACIN ZINC

CORTISPORIN, HYDROCORTISONE

CORTISPORIN, HYDROCORTISONE ACETATE

CORTROSYN, COSYNTROPIN

CORVERT, IBUTILIDE FUMARATE

CORZIDE, BENDROFLUMETHIAZIDE

COSMEGEN, DACTINOMYCIN

COSOPT, DORZOLAMIDE HYDROCHLORIDE

COSOPT PF, DORZOLAMIDE HYDROCHLORIDE

COSYNTROPIN, COSYNTROPIN

COTELLIC, COBIMETINIB FUMARATE

COUMADIN, WARFARIN SODIUM

COVERA-HS, VERAPAMIL HYDROCHLORIDE

COZAAR, LOSARTAN POTASSIUM

CREON, PANCRELIPASE (AMYLASE

CRESEMBA, ISAVUCONAZONIUM SULFATE

CRESTOR, ROSUVASTATIN CALCIUM

CRINONE, PROGESTERONE

CRIXIVAN, INDINAVIR SULFATE

CROLOM, CROMOLYN SODIUM

CROMOLYN SODIUM, CROMOLYN SODIUM

(OTC)

CROMOLYN SODIUM, CROMOLYN SODIUM

CROTAN, CROTAMITON

CRYSELLE, ETHINYL ESTRADIOL

CUBICIN, DAPTOMYCIN

CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE

CUPRIMINE, PENICILLAMINE

CUROSURF, PORACTANT ALFA

CUTIVATE, FLUTICASONE PROPIONATE

CUVPOSA, GLYCOPYRROLATE

CYANOCOBALAMIN, CYANOCOBALAMIN

CYANOKIT, HYDROXOCOBALAMIN

CYCLAFEM 0.5/35, ETHINYL ESTRADIOL

CYCLAFEM 1/35, ETHINYL ESTRADIOL

CYCLAFEM 7/7/7, ETHINYL ESTRADIOL

CYCLESSA, DESOGESTREL

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOPENTOLATE HYDROCHLORIDE, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

CYCLOSET, BROMOCRIPTINE MESYLATE

CYCLOSPORINE, CYCLOSPORINE

CYKLOKAPRON, TRANEXAMIC ACID

CYMBALTA, DULOXETINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

CYSTADANE, BETAINE HYDROCHLORIDE

CYSTAGON, CYSTEAMINE BITARTRATE

CYSTARAN, CYSTEAMINE HYDROCHLORIDE

CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE

CYSTOGRAFIN, DIATRIZOATE MEGLUMINE

CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE

CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE

CYTARABINE, CYTARABINE

CYTOMEL, LIOTHYRONINE SODIUM

CYTOSAR-U, CYTARABINE

CYTOTEC, MISOPROSTOL

CYTOVENE, GANCICLOVIR SODIUM

CYTOXAN (LYOPHILIZED), CYCLOPHOSPHAMIDE

**

**

A - 14

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 15

PRODUCT NAME INDEX

**

**

D.H.E. 45, DIHYDROERGOTAMINE MESYLATE

DACARBAZINE, DACARBAZINE

DACOGEN, DECITABINE

DACTINOMYCIN, DACTINOMYCIN

DAKLINZA, DACLATASVIR DIHYDROCHLORIDE

DALIRESP, ROFLUMILAST

DALVANCE, DALBAVANCIN HYDROCHLORIDE

DANAZOL, DANAZOL

DANTRIUM, DANTROLENE SODIUM

DANTROLENE SODIUM, DANTROLENE SODIUM

DAPSONE, DAPSONE

DAPTOMYCIN, DAPTOMYCIN

DARAPRIM, PYRIMETHAMINE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DASETTA 1/35, ETHINYL ESTRADIOL

DASETTA 7/7/7, ETHINYL ESTRADIOL

DATSCAN, IOFLUPANE I-123

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DAUNOXOME, DAUNORUBICIN CITRATE

DAYPRO, OXAPROZIN

DAYSEE, ETHINYL ESTRADIOL

DAYTRANA, METHYLPHENIDATE

DDAVP, DESMOPRESSIN ACETATE

DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DECITABINE, DECITABINE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEFINITY, PERFLUTREN

DELATESTRYL, TESTOSTERONE ENANTHATE

DELESTROGEN, ESTRADIOL VALERATE

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELSYM, DEXTROMETHORPHAN POLISTIREX

(OTC)

DELZICOL, MESALAMINE

DEMADEX, TORSEMIDE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DEMEROL, MEPERIDINE HYDROCHLORIDE

DEMSER, METYROSINE

DENAVIR, PENCICLOVIR SODIUM

DENDRID, IDOXURIDINE

DEPACON, VALPROATE SODIUM

DEPAKENE, VALPROIC ACID

DEPAKOTE, DIVALPROEX SODIUM

DEPAKOTE ER, DIVALPROEX SODIUM

DEPEN, PENICILLAMINE

DEPO-ESTRADIOL, ESTRADIOL CYPIONATE

DEPO-MEDROL, METHYLPREDNISOLONE ACETATE

DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE

DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE

DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE

DEPOCYT, CYTARABINE

DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

DERMABET, BETAMETHASONE VALERATE

DERMATOP, PREDNICARBATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 16

PRODUCT NAME INDEX

**

**

DERMATOP E EMOLLIENT, PREDNICARBATE

DERMOTIC, FLUOCINOLONE ACETONIDE

DESFERAL, DEFEROXAMINE MESYLATE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DESLORATADINE, DESLORATADINE

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DESOGEN, DESOGESTREL

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DESONATE, DESONIDE

DESONIDE, DESONIDE

DESOWEN, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

DESOXYN, METHAMPHETAMINE HYDROCHLORIDE

DESVENLAFAXINE, DESVENLAFAXINE

DESVENLAFAXINE, DESVENLAFAXINE FUMARATE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DETROL, TOLTERODINE TARTRATE

DETROL LA, TOLTERODINE TARTRATE

DEXAMETHASONE, DEXAMETHASONE

DEXAMETHASONE INTENSOL, DEXAMETHASONE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXASPORIN, DEXAMETHASONE

DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, DEXBROMPHENIRAMINE MALEATE

(OTC)

DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE

DEXEDRINE, DEXTROAMPHETAMINE SULFATE

DEXFERRUM, IRON DEXTRAN

DEXILANT, DEXLANSOPRAZOLE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX

(OTC)

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 25%, DEXTROSE

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 17

PRODUCT NAME INDEX

**

**

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER,

DEXTROSE 50% , DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DIABETA, GLYBURIDE

DIABINESE, CHLORPROPAMIDE

DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIAMOX, ACETAZOLAMIDE

DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIASTAT, DIAZEPAM

DIASTAT ACUDIAL, DIAZEPAM

DIAZEPAM, DIAZEPAM

DIAZEPAM INTENSOL, DIAZEPAM

DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE

DICLEGIS, DOXYLAMINE SUCCINATE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICLOFENAC SODIUM , DICLOFENAC SODIUM

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE

DIDANOSINE, DIDANOSINE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

DIDRONEL, ETIDRONATE DISODIUM

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DIFFERIN, ADAPALENE

DIFICID, FIDAXOMICIN

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

DIFLUCAN, FLUCONAZOLE

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUNISAL, DIFLUNISAL

DIGOXIN, DIGOXIN

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

DILANTIN, PHENYTOIN

DILANTIN, PHENYTOIN SODIUM

DILANTIN-125, PHENYTOIN

DILATRATE-SR, ISOSORBIDE DINITRATE

DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DILTZAC, DILTIAZEM HYDROCHLORIDE

DIMENHYDRINATE, DIMENHYDRINATE

DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE

DIOVAN, VALSARTAN

DIOVAN HCT, HYDROCHLOROTHIAZIDE

DIPENTUM, OLSALAZINE SODIUM

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DIPRIVAN, PROPOFOL

DIPROLENE, BETAMETHASONE DIPROPIONATE

DIPROLENE AF, BETAMETHASONE DIPROPIONATE

DIPYRIDAMOLE, DIPYRIDAMOLE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DISULFIRAM, DISULFIRAM

DISULFIRAM , DISULFIRAM

DITROPAN XL, OXYBUTYNIN CHLORIDE

DIURIL, CHLOROTHIAZIDE

DIURIL, CHLOROTHIAZIDE SODIUM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DIVIGEL, ESTRADIOL

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOCEFREZ, DOCETAXEL

DOCETAXEL, DOCETAXEL

DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPRAM, DOXAPRAM HYDROCHLORIDE

DORIBAX, DORIPENEM

DORYX, DOXYCYCLINE HYCLATE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOTAREM, GADOTERATE MEGLUMINE

DOVONEX, CALCIPOTRIENE

DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

DOXTERIC, DOXYCYCLINE HYCLATE

A - 18

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

DOXY 100, DOXYCYCLINE HYCLATE

DOXY 200, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

DOXYCYCLINE, DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE

(OTC)

DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE

DRISDOL, ERGOCALCIFEROL

DRONABINOL, DRONABINOL

DROPERIDOL, DROPERIDOL

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

DROXIA, HYDROXYUREA

DTIC-DOME, DACARBAZINE

DTPA, TECHNETIUM TC-99M PENTETATE KIT

DUAC, BENZOYL PEROXIDE

DUAVEE, BAZEDOXIFENE ACETATE

DUETACT, GLIMEPIRIDE

DUEXIS, FAMOTIDINE

DULERA, FORMOTEROL FUMARATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUODOTE, ATROPINE

DUONEB, ALBUTEROL SULFATE

DUOPA, CARBIDOPA

DURACLON, CLONIDINE HYDROCHLORIDE

DURAGESIC-100, FENTANYL

DURAGESIC-12, FENTANYL

DURAGESIC-25, FENTANYL

DURAGESIC-50, FENTANYL

DURAGESIC-75, FENTANYL

DURAMORPH PF, MORPHINE SULFATE

DURAPREP, IODINE POVACRYLEX

(OTC)

DUREZOL, DIFLUPREDNATE

DURLAZA, ASPIRIN

DUTASTERIDE, DUTASTERIDE

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE

DUTOPROL, HYDROCHLOROTHIAZIDE

DUVOID, BETHANECHOL CHLORIDE

DYANAVEL XR, AMPHETAMINE

DYAZIDE, HYDROCHLOROTHIAZIDE

DYLOJECT, DICLOFENAC SODIUM

DYMISTA, AZELASTINE HYDROCHLORIDE

DYNA-HEX, CHLORHEXIDINE GLUCONATE

(OTC)

DYNACIN, MINOCYCLINE HYDROCHLORIDE

DYRENIUM, TRIAMTERENE

**
E-Z SCRUB 201, POVIDONE-IODINE
(OTC)

E-Z SCRUB 241, POVIDONE-IODINE

(OTC)

E.E.S., ERYTHROMYCIN ETHYLSUCCINATE

E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE

EC-NAPROSYN, NAPROXEN

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ECOZA, ECONAZOLE NITRATE

EDARBI, AZILSARTAN KAMEDOXOMIL

EDARBYCLOR, AZILSARTAN KAMEDOXOMIL

EDECRIN, ETHACRYNATE SODIUM

EDECRIN, ETHACRYNIC ACID

EDEX, ALPROSTADIL

EDLUAR, ZOLPIDEM TARTRATE

EDURANT, RILPIVIRINE HYDROCHLORIDE

EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE

EFFIENT, PRASUGREL HYDROCHLORIDE

EFUDEX, FLUOROURACIL

EGRIFTA, TESAMORELIN ACETATE

ELDEPRYL, SELEGILINE HYDROCHLORIDE

**

A - 19

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ELELYSO, TALIGLUCERASE ALFA

ELESTAT, EPINASTINE HYDROCHLORIDE

ELESTRIN, ESTRADIOL

ELIDEL, PIMECROLIMUS

ELIFEMME, ETHINYL ESTRADIOL

ELIGARD, LEUPROLIDE ACETATE

ELIMITE, PERMETHRIN

ELINEST, ETHINYL ESTRADIOL

ELIPHOS, CALCIUM ACETATE

ELIQUIS, APIXABAN

ELIXOPHYLLIN, THEOPHYLLINE

ELLA, ULIPRISTAL ACETATE

ELLENCE, EPIRUBICIN HYDROCHLORIDE

ELLIOTTS B SOLUTION, CALCIUM CHLORIDE

ELMIRON, PENTOSAN POLYSULFATE SODIUM

ELOCON, MOMETASONE FUROATE

ELOXATIN, OXALIPLATIN

EMADINE, EMEDASTINE DIFUMARATE

EMBEDA, MORPHINE SULFATE

EMBELINE, CLOBETASOL PROPIONATE

EMBELINE E, CLOBETASOL PROPIONATE

EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM

EMEND, APREPITANT

EMEND, FOSAPREPITANT DIMEGLUMINE

EMLA, LIDOCAINE

EMOQUETTE, DESOGESTREL

EMSAM, SELEGILINE

EMTRIVA, EMTRICITABINE

ENABLEX, DARIFENACIN HYDROBROMIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ENALAPRILAT, ENALAPRILAT

ENDOMETRIN, PROGESTERONE

ENDOSOL EXTRA, CALCIUM CHLORIDE

ENFLURANE, ENFLURANE

ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B

ENLON, EDROPHONIUM CHLORIDE

ENLON-PLUS, ATROPINE SULFATE

ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

ENPRESSE-28, ETHINYL ESTRADIOL

ENSKYCE, DESOGESTREL

ENSTILAR, BETAMETHASONE DIPROPIONATE

ENTACAPONE, ENTACAPONE

ENTECAVIR, ENTECAVIR

ENTEREG, ALVIMOPAN

ENTOCORT EC, BUDESONIDE

ENTRESTO, SACUBITRIL

ENULOSE, LACTULOSE

ENVARSUS XR, TACROLIMUS

EOVIST, GADOXETATE DISODIUM

EPANED KIT, ENALAPRIL MALEATE

EPANOVA, OMEGA-3-CARBOXYLIC ACIDS

EPIDUO, ADAPALENE

EPIDUO FORTE, ADAPALENE

EPIFOAM, HYDROCORTISONE ACETATE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

EPINEPHRINE, EPINEPHRINE HYDROCHLORIDE

EPIPEN, EPINEPHRINE

EPIPEN JR., EPINEPHRINE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

EPITOL, CARBAMAZEPINE

EPIVIR, LAMIVUDINE

EPIVIR-HBV, LAMIVUDINE

EPLERENONE, EPLERENONE

A - 20

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM

EPROSARTAN MESYLATE, EPROSARTAN MESYLATE

EPTIFIBATIDE, EPTIFIBATIDE

EPZICOM, ABACAVIR SULFATE

EQUETRO, CARBAMAZEPINE

ERAXIS, ANIDULAFUNGIN

ERGOCALCIFEROL, ERGOCALCIFEROL

ERGOLOID MESYLATES, ERGOLOID MESYLATES

ERGOMAR, ERGOTAMINE TARTRATE

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ERIVEDGE, VISMODEGIB

ERRIN, NORETHINDRONE

ERTACZO, SERTACONAZOLE NITRATE

ERY-TAB, ERYTHROMYCIN

ERYC, ERYTHROMYCIN

ERYGEL, ERYTHROMYCIN

ERYPED, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHRO-STATIN, ERYTHROMYCIN

ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE

ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE

ERYTHROMYCIN, ERYTHROMYCIN

ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE

ESBRIET, PIRFENIDONE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ESOMEPRAZOLE STRONTIUM, ESOMEPRAZOLE STRONTIUM

ESTARYLLA, ETHINYL ESTRADIOL

ESTAZOLAM, ESTAZOLAM

ESTRACE, ESTRADIOL

ESTRADERM, ESTRADIOL

ESTRADIOL, ESTRADIOL

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

ESTRADIOL AND NORGESTIMATE, ESTRADIOL

ESTRADIOL VALERATE, ESTRADIOL VALERATE

ESTRASORB, ESTRADIOL HEMIHYDRATE

ESTRING, ESTRADIOL

ESTROGEL, ESTRADIOL

ESTROPIPATE, ESTROPIPATE

ESTROSTEP FE, ETHINYL ESTRADIOL

ESZOPICLONE, ESZOPICLONE

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

ETHAMOLIN, ETHANOLAMINE OLEATE

ETHOSUXIMIDE, ETHOSUXIMIDE

ETHRANE, ENFLURANE

ETHYOL, AMIFOSTINE

ETIDRONATE DISODIUM, ETIDRONATE DISODIUM

ETODOLAC, ETODOLAC

ETOMIDATE, ETOMIDATE

ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE

ETOPOSIDE, ETOPOSIDE

EURAX, CROTAMITON

EVAMIST, ESTRADIOL

EVEKEO, AMPHETAMINE SULFATE

EVISTA, RALOXIFENE HYDROCHLORIDE

EVOCLIN, CLINDAMYCIN PHOSPHATE

EVOTAZ, ATAZANAVIR SULFATE

EVOXAC, CEVIMELINE HYDROCHLORIDE

EVZIO, NALOXONE HYDROCHLORIDE

EXALGO, HYDROMORPHONE HYDROCHLORIDE

EXCEDRIN (MIGRAINE), ACETAMINOPHEN

(OTC)

A - 21

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 22

PRODUCT NAME INDEX

**

**

**

EXELDERM, SULCONAZOLE NITRATE

EXELON, RIVASTIGMINE

EXELON, RIVASTIGMINE TARTRATE

EXEMESTANE, EXEMESTANE

EXFORGE, AMLODIPINE BESYLATE

EXFORGE HCT, AMLODIPINE BESYLATE

EXIDINE, CHLORHEXIDINE GLUCONATE

(OTC)

EXJADE, DEFERASIROX

EXPAREL, BUPIVACAINE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

EXTINA, KETOCONAZOLE

EXTRANEAL, ICODEXTRIN

**

FABIOR, TAZAROTENE

FACTIVE, GEMIFLOXACIN MESYLATE

FALLBACK SOLO, LEVONORGESTREL

(OTC)

FALMINA, ETHINYL ESTRADIOL

FAMCICLOVIR, FAMCICLOVIR

FAMOTIDINE, FAMOTIDINE
(OTC)

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

FAMVIR, FAMCICLOVIR

FANAPT, ILOPERIDONE

FARESTON, TOREMIFENE CITRATE

FARXIGA, DAPAGLIFLOZIN PROPANEDIOL

FARYDAK, PANOBINOSTAT LACTATE

FASLODEX, FULVESTRANT

FAZACLO ODT, CLOZAPINE

FELBAMATE, FELBAMATE

FELBATOL, FELBAMATE

FELDENE, PIROXICAM

FELODIPINE, FELODIPINE

FEMARA, LETROZOLE

FEMCON FE, ETHINYL ESTRADIOL

FEMHRT, ETHINYL ESTRADIOL

FEMRING, ESTRADIOL ACETATE

FEMSTAT 3, BUTOCONAZOLE NITRATE

(OTC)

FEMTRACE, ESTRADIOL ACETATE

FENOFIBRATE, FENOFIBRATE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FENOGLIDE, FENOFIBRATE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

FENTANYL CITRATE, FENTANYL CITRATE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-37, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-62, FENTANYL

FENTANYL-75, FENTANYL

FENTANYL-87, FENTANYL

FENTORA, FENTANYL CITRATE

FERAHEME, FERUMOXYTOL

FERRIPROX, DEFERIPRONE

FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 23

PRODUCT NAME INDEX

**

**

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

FIBRICOR, FENOFIBRIC ACID

FINACEA, AZELAIC ACID

FINACEA , AZELAIC ACID

FINASTERIDE, FINASTERIDE

FIORICET W/ CODEINE, ACETAMINOPHEN

FIORINAL, ASPIRIN

FIORINAL W/CODEINE, ASPIRIN

FIRAZYR, ICATIBANT ACETATE

FIRMAGON, DEGARELIX ACETATE

FLAGYL, METRONIDAZOLE

FLAGYL ER, METRONIDAZOLE

FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

FLAREX, FLUOROMETHOLONE ACETATE

FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLECTOR, DICLOFENAC EPOLAMINE

FLOLAN, EPOPROSTENOL SODIUM

FLOMAX, TAMSULOSIN HYDROCHLORIDE

FLONASE, FLUTICASONE PROPIONATE

FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE

(OTC)

FLOVENT DISKUS 100, FLUTICASONE PROPIONATE

FLOVENT DISKUS 250, FLUTICASONE PROPIONATE

FLOVENT DISKUS 50, FLUTICASONE PROPIONATE

FLOVENT HFA, FLUTICASONE PROPIONATE

FLOWTUSS, GUAIFENESIN

FLOXIN OTIC, OFLOXACIN

FLOXURIDINE, FLOXURIDINE

FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE, FLUCONAZOLE

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCYTOSINE, FLUCYTOSINE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

FLUMADINE, RIMANTADINE HYDROCHLORIDE

FLUMAZENIL, FLUMAZENIL

FLUNISOLIDE, FLUNISOLIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUORESCITE, FLUORESCEIN SODIUM

FLUOROPLEX, FLUOROURACIL

FLUOROURACIL, FLUOROURACIL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUOXYMESTERONE, FLUOXYMESTERONE

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM

FLUTAMIDE, FLUTAMIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FML, FLUOROMETHOLONE

FML FORTE, FLUOROMETHOLONE

FOAMCOAT, ALUMINUM HYDROXIDE

(OTC)

FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

FOLLISTIM AQ, FOLLITROPIN ALFA/BETA

FOLOTYN, PRALATREXATE

FOMEPIZOLE, FOMEPIZOLE

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

FORADIL, FORMOTEROL FUMARATE

FORANE, ISOFLURANE

FORFIVO XL, BUPROPION HYDROCHLORIDE

FORTAMET, METFORMIN HYDROCHLORIDE

FORTAZ, CEFTAZIDIME

FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM

FORTEO, TERIPARATIDE RECOMBINANT HUMAN

FORTESTA, TESTOSTERONE

FORTICAL, CALCITONIN SALMON RECOMBINANT

FOSAMAX, ALENDRONATE SODIUM

FOSAMAX PLUS D, ALENDRONATE SODIUM

FOSCARNET SODIUM, FOSCARNET SODIUM

FOSCAVIR, FOSCARNET SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FOSRENOL, LANTHANUM CARBONATE

FRAGMIN, DALTEPARIN SODIUM

FREAMINE HBC 6.9%, AMINO ACIDS

FREAMINE III 10%, AMINO ACIDS

FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS

FREAMINE III 8.5%, AMINO ACIDS

FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS

FROVA, FROVATRIPTAN SUCCINATE

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

FULYZAQ, CROFELEMER

FURADANTIN, NITROFURANTOIN

FUROSEMIDE, FUROSEMIDE

FUSILEV, LEVOLEUCOVORIN CALCIUM

FUZEON, ENFUVIRTIDE

FYAVOLV, ETHINYL ESTRADIOL

FYCOMPA, PERAMPANEL

**

**

GABAPENTIN, GABAPENTIN

GABITRIL, TIAGABINE HYDROCHLORIDE

GABLOFEN, BACLOFEN

GADAVIST, GADOBUTROL

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67

GALZIN, ZINC ACETATE

GANCICLOVIR, GANCICLOVIR SODIUM

GANIRELIX ACETATE, GANIRELIX ACETATE

GASTROCROM, CROMOLYN SODIUM

GASTROGRAFIN, DIATRIZOATE MEGLUMINE

GATIFLOXACIN, GATIFLOXACIN

GATTEX KIT, TEDUGLUTIDE RECOMBINANT

GAVISCON, ALUMINUM HYDROXIDE

(OTC)

GELNIQUE, OXYBUTYNIN CHLORIDE

GELNIQUE 3%, OXYBUTYNIN

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GEMFIBROZIL, GEMFIBROZIL

GEMIFLOXACIN MESYLATE, GEMIFLOXACIN MESYLATE

GEMZAR, GEMCITABINE HYDROCHLORIDE

GEN-XENE, CLORAZEPATE DIPOTASSIUM

GENERLAC, LACTULOSE

GENGRAF, CYCLOSPORINE

GENOPTIC, GENTAMICIN SULFATE

GENOTROPIN, SOMATROPIN RECOMBINANT

GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT

GENTAK, GENTAMICIN SULFATE

A - 24

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

GENVOYA, COBICISTAT

GEODON, ZIPRASIDONE HYDROCHLORIDE

GEODON, ZIPRASIDONE MESYLATE

GIAZO, BALSALAZIDE DISODIUM

GILDAGIA, ETHINYL ESTRADIOL

GILDESS 1.5/30, ETHINYL ESTRADIOL

GILDESS 1/20, ETHINYL ESTRADIOL

GILDESS 24 FE, ETHINYL ESTRADIOL

GILDESS FE 1.5/30, ETHINYL ESTRADIOL

GILDESS FE 1/20, ETHINYL ESTRADIOL

GILENYA, FINGOLIMOD

GILOTRIF, AFATINIB DIMALEATE

GLATOPA, GLATIRAMER ACETATE

GLEEVEC, IMATINIB MESYLATE

GLEOSTINE, LOMUSTINE

GLIADEL, CARMUSTINE

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE, GLIPIZIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLOFIL-125, IOTHALAMATE SODIUM I-125

GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT

GLUCAGON, GLUCAGON HYDROCHLORIDE

GLUCAGON, GLUCAGON RECOMBINANT

GLUCOPHAGE, METFORMIN HYDROCHLORIDE

GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE

GLUCOTROL, GLIPIZIDE

GLUCOTROL XL, GLIPIZIDE

GLUCOVANCE, GLYBURIDE

GLUMETZA, METFORMIN HYDROCHLORIDE

GLYBURIDE, GLYBURIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

GLYCOLAX, POLYETHYLENE GLYCOL 3350

(OTC)

GLYCOLAX, POLYETHYLENE GLYCOL 3350

GLYCOPYRROLATE, GLYCOPYRROLATE

GLYDO, LIDOCAINE HYDROCHLORIDE

GLYNASE, GLYBURIDE

GLYSET, MIGLITOL

GLYXAMBI, EMPAGLIFLOZIN

GOLYTELY, POLYETHYLENE GLYCOL 3350

GONAL-F, FOLLITROPIN ALFA/BETA

GONAL-F RFF, FOLLITROPIN ALFA/BETA

GONAL-F RFF REDI-JECT, FOLLITROPIN ALFA/BETA

GRALISE, GABAPENTIN

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

GUAIFENESIN, GUAIFENESIN
(OTC)

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE

(OTC)

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN

(OTC)

GUANABENZ ACETATE, GUANABENZ ACETATE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE

GYNAZOLE-1, BUTOCONAZOLE NITRATE

GYNE-LOTRIMIN, CLOTRIMAZOLE
(OTC)

GYNE-LOTRIMIN 3, CLOTRIMAZOLE
(OTC)

GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE

(OTC)

GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE

(OTC)

A - 25

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 26

PRODUCT NAME INDEX

**

**

H.P. ACTHAR GEL, CORTICOTROPIN

HABITROL, NICOTINE
(OTC)

HALAVEN, ERIBULIN MESYLATE

HALCION, TRIAZOLAM

HALDOL, HALOPERIDOL DECANOATE

HALDOL, HALOPERIDOL LACTATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HALOG, HALCINONIDE

HALOPERIDOL, HALOPERIDOL

HALOPERIDOL, HALOPERIDOL LACTATE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HARVONI, LEDIPASVIR

HEATHER, NORETHINDRONE

HECTOROL, DOXERCALCIFEROL

HEMABATE, CARBOPROST TROMETHAMINE

HEMANGEOL, PROPRANOLOL HYDROCHLORIDE

HEPARIN SODIUM, HEPARIN SODIUM

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPATAMINE 8%, AMINO ACIDS

HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT

HEPSERA, ADEFOVIR DIPIVOXIL

HERPLEX, IDOXURIDINE

HETLIOZ, TASIMELTEON

HEXALEN, ALTRETAMINE

HIBICLENS, CHLORHEXIDINE GLUCONATE

(OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE

(OTC)

HICON, SODIUM IODIDE I-131

HIPREX, METHENAMINE HIPPURATE

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE

HORIZANT, GABAPENTIN ENACARBIL

HUMALOG, INSULIN LISPRO RECOMBINANT

HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT

HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMATROPE, SOMATROPIN RECOMBINANT

HUMULIN 70/30, INSULIN RECOMBINANT HUMAN

(OTC)

HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN

(OTC)

HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

(OTC)

HUMULIN R, INSULIN RECOMBINANT HUMAN

(OTC)

HUMULIN R, INSULIN RECOMBINANT HUMAN

HUMULIN R PEN, INSULIN RECOMBINANT HUMAN

(OTC)

HYCAMTIN, TOPOTECAN HYDROCHLORIDE

HYCOFENIX, GUAIFENESIN

HYDERGINE, ERGOLOID MESYLATES

HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDREA, HYDROXYUREA

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

A - 27

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE ,

HYDROCODONE BITARTRATE,CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX

HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX

HYDROCORTISONE, HYDROCORTISONE

HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

HYDROXOCOBALAMIN, HYDROXOCOBALAMIN

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE

HYDROXYUREA, HYDROXYUREA

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN

HYSINGLA, HYDROCODONE BITARTRATE

HYZAAR, HYDROCHLOROTHIAZIDE

**

**

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IBRANCE, PALBOCICLIB

IBU-TAB, IBUPROFEN

IBU-TAB 200, IBUPROFEN

(OTC)

IBUPROFEN, IBUPROFEN
(OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE

(OTC)

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, IBUPROFEN
(OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN

(OTC)

IBUPROFEN SODIUM, IBUPROFEN SODIUM

(OTC)

IBUPROHM, IBUPROFEN
(OTC)

IBUPROHM COLD AND SINUS, IBUPROFEN

(OTC)

IBUTILIDE FUMARATE, IBUTILIDE FUMARATE

IC-GREEN, INDOCYANINE GREEN

ICLUSIG, PONATINIB HYDROCHLORIDE

IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE

IDKIT:HP, CITRIC ACID

IFEX, IFOSFAMIDE

IFOSFAMIDE, IFOSFAMIDE

IFOSFAMIDE/MESNA KIT, IFOSFAMIDE

ILEVRO, NEPAFENAC

ILUVIEN, FLUOCINOLONE ACETONIDE

IMATINIB MESYLATE, IMATINIB MESYLATE

IMBRUVICA, IBRUTINIB

IMIPENEM AND CILASTATIN, CILASTATIN SODIUM

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE

IMIQUIMOD, IMIQUIMOD

IMITREX, SUMATRIPTAN

IMITREX, SUMATRIPTAN SUCCINATE

IMITREX STATDOSE, SUMATRIPTAN SUCCINATE

IMODIUM, LOPERAMIDE HYDROCHLORIDE

IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE

(OTC)

IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE

(OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE

(OTC)

IMPAVIDO, MILTEFOSINE

IMURAN, AZATHIOPRINE

INAPSINE, DROPERIDOL

(OTC)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

INCRELEX, MECASERMIN RECOMBINANT

INCRUSE ELLIPTA , UMECLIDINIUM BROMIDE

INDAPAMIDE, INDAPAMIDE

INDERAL LA, PROPRANOLOL HYDROCHLORIDE

INDICLOR, INDIUM IN-111 CHLORIDE

INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE

INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE

INDOCIN, INDOMETHACIN

INDOCIN, INDOMETHACIN SODIUM

INDOCYANINE GREEN, INDOCYANINE GREEN

INDOMETHACIN, INDOMETHACIN

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

INFANTS' FEVERALL, ACETAMINOPHEN

(OTC)

INFASURF PRESERVATIVE FREE, CALFACTANT

INFED, IRON DEXTRAN

INFUMORPH, MORPHINE SULFATE

INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE

INFUVITE PEDIATRIC, ASCORBIC ACID

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID

INJECTAFER, FERRIC CARBOXYMALTOSE

INLYTA, AXITINIB

INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE

INOMAX, NITRIC OXIDE

INSPRA, EPLERENONE

INTEGRILIN, EPTIFIBATIDE

INTELENCE, ETRAVIRINE

INTERMEZZO, ZOLPIDEM TARTRATE

INTRALIPID 10%, SOYBEAN OIL

INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL

INTROVALE, ETHINYL ESTRADIOL

INTUNIV, GUANFACINE HYDROCHLORIDE

INVANZ, ERTAPENEM SODIUM

INVEGA, PALIPERIDONE

INVEGA SUSTENNA, PALIPERIDONE PALMITATE

INVEGA TRINZA, PALIPERIDONE PALMITATE

INVIRASE, SAQUINAVIR MESYLATE

INVOKAMET, CANAGLIFLOZIN

INVOKANA, CANAGLIFLOZIN

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

IONSYS, FENTANYL HYDROCHLORIDE

IOPIDINE, APRACLONIDINE HYDROCHLORIDE

IOSAT, POTASSIUM IODIDE

(OTC)

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

IPRIVASK, DESIRUDIN RECOMBINANT

IRBESARTAN, IRBESARTAN

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRESSA, GEFITINIB

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISENTRESS, RALTEGRAVIR POTASSIUM

ISIBLOOM, DESOGESTREL

ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

ISOFLURANE, ISOFLURANE

ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ISONIAZID, ISONIAZID

ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE

ISORDIL, ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

ISOSULFAN BLUE, ISOSULFAN BLUE

A - 28

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

**

ISOVUE-200, IOPAMIDOL

ISOVUE-250, IOPAMIDOL

ISOVUE-300, IOPAMIDOL

ISOVUE-370, IOPAMIDOL

ISOVUE-M 200, IOPAMIDOL

ISOVUE-M 300, IOPAMIDOL

ISRADIPINE, ISRADIPINE

ISTALOL, TIMOLOL MALEATE

ISTODAX, ROMIDEPSIN

ISUPREL, ISOPROTERENOL HYDROCHLORIDE

ITRACONAZOLE, ITRACONAZOLE

IVERMECTIN, IVERMECTIN

IVY BLOCK, BENTOQUATAM

(OTC)

IXEMPRA KIT, IXABEPILONE

JADENU, DEFERASIROX

JAKAFI, RUXOLITINIB PHOSPHATE

JALYN, DUTASTERIDE

JANTOVEN, WARFARIN SODIUM

JANUMET, METFORMIN HYDROCHLORIDE

JANUMET XR, METFORMIN HYDROCHLORIDE

JANUVIA, SITAGLIPTIN PHOSPHATE

JARDIANCE, EMPAGLIFLOZIN

JEANATOPE, ALBUMIN IODINATED I-125 SERUM

JENCYCLA, NORETHINDRONE

JENTADUETO, LINAGLIPTIN

JEVTANA KIT, CABAZITAXEL

JUBLIA, EFINACONAZOLE

JUNEL 1.5/30, ETHINYL ESTRADIOL

JUNEL 1/20, ETHINYL ESTRADIOL

JUNEL FE 1.5/30, ETHINYL ESTRADIOL

JUNEL FE 1/20, ETHINYL ESTRADIOL

JUNIOR STRENGTH ADVIL, IBUPROFEN

(OTC)

JUNIOR STRENGTH IBUPROFEN, IBUPROFEN

(OTC)

JUNIOR STRENGTH MOTRIN, IBUPROFEN

(OTC)

JUXTAPID, LOMITAPIDE MESYLATE

**

K-TAB, POTASSIUM CHLORIDE

KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

KADIAN, MORPHINE SULFATE

KAITLIB FE, ETHINYL ESTRADIOL

KALETRA, LOPINAVIR

KALEXATE, SODIUM POLYSTYRENE SULFONATE

KALYDECO, IVACAFTOR

KANAMYCIN SULFATE, KANAMYCIN SULFATE

KAPVAY, CLONIDINE HYDROCHLORIDE

KARBINAL ER, CARBINOXAMINE MALEATE

KARIVA, DESOGESTREL

KAYEXALATE, SODIUM POLYSTYRENE SULFONATE

KAZANO, ALOGLIPTIN BENZOATE

KEFLEX, CEPHALEXIN

KEFZOL, CEFAZOLIN SODIUM

KELNOR, ETHINYL ESTRADIOL

KENALOG, TRIAMCINOLONE ACETONIDE

KENALOG-10, TRIAMCINOLONE ACETONIDE

KENALOG-40, TRIAMCINOLONE ACETONIDE

KENGREAL, CANGRELOR

KEPPRA, LEVETIRACETAM

KEPPRA XR, LEVETIRACETAM

KERYDIN, TAVABOROLE

KETALAR, KETAMINE HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

KETEK, TELITHROMYCIN

**

A - 29

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

KETOCONAZOLE, KETOCONAZOLE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE

(OTC)

KETOZOLE, KETOCONAZOLE

KEVEYIS, DICHLORPHENAMIDE

KHEDEZLA, DESVENLAFAXINE

KIMIDESS, DESOGESTREL

KINEVAC, SINCALIDE

KIONEX, SODIUM POLYSTYRENE SULFONATE

KITABIS PAK, TOBRAMYCIN

KLARON, SULFACETAMIDE SODIUM

KLONOPIN, CLONAZEPAM

KLOR-CON, POTASSIUM CHLORIDE

KLOR-CON M10, POTASSIUM CHLORIDE

KLOR-CON M15, POTASSIUM CHLORIDE

KLOR-CON M20, POTASSIUM CHLORIDE

KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE

KORLYM, MIFEPRISTONE

KURVELO, ETHINYL ESTRADIOL

KUVAN, SAPROPTERIN DIHYDROCHLORIDE

KYBELLA, DEOXYCHOLIC ACID

KYNAMRO, MIPOMERSEN SODIUM

KYPROLIS, CARFILZOMIB

**

**

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE

LAC-HYDRIN, AMMONIUM LACTATE

LACRISERT, HYDROXYPROPYL CELLULOSE

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LACTULOSE, LACTULOSE

LAMICTAL, LAMOTRIGINE

LAMICTAL CD, LAMOTRIGINE

LAMICTAL ODT, LAMOTRIGINE

LAMICTAL XR, LAMOTRIGINE

LAMISIL, TERBINAFINE HYDROCHLORIDE

(OTC)

LAMISIL, TERBINAFINE HYDROCHLORIDE

LAMISIL AT, TERBINAFINE

(OTC)

LAMISIL AT, TERBINAFINE HYDROCHLORIDE

(OTC)

LAMIVUDINE, LAMIVUDINE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LAMPRENE, CLOFAZIMINE

LANIAZID, ISONIAZID

LANORINAL, ASPIRIN

LANOXIN, DIGOXIN

LANOXIN PEDIATRIC, DIGOXIN

LANSOPRAZOLE, LANSOPRAZOLE
(OTC)

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE , LANSOPRAZOLE

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN

LANTUS, INSULIN GLARGINE RECOMBINANT

LANTUS SOLOSTAR, INSULIN GLARGINE RECOMBINANT

LARIN 1.5/30, ETHINYL ESTRADIOL

LARIN 1/20, ETHINYL ESTRADIOL

LARIN 24 FE, ETHINYL ESTRADIOL

LARIN FE 1.5/30, ETHINYL ESTRADIOL

LARIN FE 1/20, ETHINYL ESTRADIOL

LAROTID, AMOXICILLIN

LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE

LASIX, FUROSEMIDE

LASTACAFT, ALCAFTADINE

LATANOPROST, LATANOPROST

A - 30

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 31

PRODUCT NAME INDEX

**

**

LATISSE, BIMATOPROST

LATUDA, LURASIDONE HYDROCHLORIDE

LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

LAZANDA, FENTANYL CITRATE

LEFLUNOMIDE, LEFLUNOMIDE

LENVIMA, LENVATINIB MESYLATE

LESCOL, FLUVASTATIN SODIUM

LESCOL XL, FLUVASTATIN SODIUM

LESSINA-28, ETHINYL ESTRADIOL

LETAIRIS, AMBRISENTAN

LETROZOLE, LETROZOLE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEUKERAN, CHLORAMBUCIL

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LEVAQUIN, LEVOFLOXACIN

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVEMIR, INSULIN DETEMIR RECOMBINANT

LEVEMIR FLEXPEN, INSULIN DETEMIR RECOMBINANT

LEVEMIR FLEXTOUCH, INSULIN DETEMIR RECOMBINANT

LEVETIRACETAM, LEVETIRACETAM

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

LEVITRA, VARDENAFIL HYDROCHLORIDE

LEVO-T, LEVOTHYROXINE SODIUM **

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

LEVOCARNITINE, LEVOCARNITINE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

LEVONEST, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL
(OTC)

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVOPHED, NOREPINEPHRINE BITARTRATE

LEVORA 0.15/30-28, ETHINYL ESTRADIOL

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

LEVOTHROID, LEVOTHYROXINE SODIUM **

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

LEVOXYL, LEVOTHYROXINE SODIUM **

LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE

LEXAPRO, ESCITALOPRAM OXALATE

LEXISCAN, REGADENOSON

LEXIVA, FOSAMPRENAVIR CALCIUM

LIALDA, MESALAMINE

LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE

LIDEX, FLUOCINONIDE

LIDOCAINE, LIDOCAINE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE

LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

LIDODERM, LIDOCAINE

LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE

LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE

LILETTA, LEVONORGESTREL

LINCOCIN, LINCOMYCIN HYDROCHLORIDE

LINCOMYCIN, LINCOMYCIN HYDROCHLORIDE

LINDANE, LINDANE

LINEZOLID, LINEZOLID

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, LINEZOLID

LINZESS, LINACLOTIDE

LIORESAL, BACLOFEN

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

LIPIODOL, ETHIODIZED OIL

LIPITOR, ATORVASTATIN CALCIUM

LIPOFEN, FENOFIBRATE

LISINOPRIL, LISINOPRIL

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

LITHIUM CITRATE, LITHIUM CITRATE

LITHOBID, LITHIUM CARBONATE

LITHOSTAT, ACETOHYDROXAMIC ACID

LIVALO, PITAVASTATIN CALCIUM

LO LOESTRIN FE, ETHINYL ESTRADIOL

LO MINASTRIN FE, ETHINYL ESTRADIOL

LO/OVRAL-28, ETHINYL ESTRADIOL

LOCOID, HYDROCORTISONE BUTYRATE

LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE

LODOSYN, CARBIDOPA

LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL

LOESTRIN 21 1/20, ETHINYL ESTRADIOL

LOESTRIN 24 FE, ETHINYL ESTRADIOL

LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL

LOESTRIN FE 1/20, ETHINYL ESTRADIOL

LOMOTIL, ATROPINE SULFATE

LONOX, ATROPINE SULFATE

LONSURF, TIPIRACIL HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE

LOPID, GEMFIBROZIL

LOPRESSOR, METOPROLOL TARTRATE

LOPRESSOR HCT, HYDROCHLOROTHIAZIDE

LOPROX, CICLOPIROX

LOPURIN, ALLOPURINOL

LORATADINE, LORATADINE
(OTC)

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE

(OTC)

LORATADINE REDIDOSE, LORATADINE

(OTC)

LORAZEPAM, LORAZEPAM

LORAZEPAM INTENSOL, LORAZEPAM

LORAZEPAM PRESERVATIVE FREE, LORAZEPAM

LORYNA, DROSPIRENONE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSEASONIQUE, ETHINYL ESTRADIOL

LOTEMAX, LOTEPREDNOL ETABONATE

LOTENSIN, BENAZEPRIL HYDROCHLORIDE

LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE

LOTREL, AMLODIPINE BESYLATE

LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE

(OTC)

LOTRISONE, BETAMETHASONE DIPROPIONATE

LOTRONEX, ALOSETRON HYDROCHLORIDE

LOVASTATIN, LOVASTATIN

LOVAZA, OMEGA-3-ACID ETHYL ESTERS

LOVENOX, ENOXAPARIN SODIUM

LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM

(OTC)

A - 32

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

LOW-OGESTREL-28, ETHINYL ESTRADIOL

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

LTA II KIT, LIDOCAINE HYDROCHLORIDE

LUFYLLIN, DYPHYLLINE

LUMASON, SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

LUMIGAN, BIMATOPROST

LUNESTA, ESZOPICLONE

LUPANETA PACK, LEUPROLIDE ACETATE

LUPRON DEPOT, LEUPROLIDE ACETATE

LUPRON DEPOT-PED, LEUPROLIDE ACETATE

LUVOX, FLUVOXAMINE MALEATE

LUVOX CR, FLUVOXAMINE MALEATE

LUXIQ, BETAMETHASONE VALERATE

LUZU, LULICONAZOLE

LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT

LYNPARZA, OLAPARIB

LYRICA, PREGABALIN

LYSODREN, MITOTANE

LYSTEDA, TRANEXAMIC ACID

**

**

M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

M.V.I. ADULT, ASCORBIC ACID

M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID

M.V.I. PEDIATRIC, ASCORBIC ACID

M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID

MACROBID, NITROFURANTOIN

MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE

MACUGEN, PEGAPTANIB SODIUM

MAFENIDE ACETATE, MAFENIDE ACETATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNEVIST, GADOPENTETATE DIMEGLUMINE

MAKENA, HYDROXYPROGESTERONE CAPROATE

MALARONE, ATOVAQUONE

MALARONE PEDIATRIC, ATOVAQUONE

MALATHION, MALATHION

MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE

MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 25%, MANNITOL

MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL

MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE

MARCAINE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARINOL, DRONABINOL

MARLISSA, ETHINYL ESTRADIOL

MARPLAN, ISOCARBOXAZID

MARQIBO KIT, VINCRISTINE SULFATE

MATULANE, PROCARBAZINE HYDROCHLORIDE

MAVIK, TRANDOLAPRIL

MAXALT, RIZATRIPTAN BENZOATE

MAXALT-MLT, RIZATRIPTAN BENZOATE

MAXIDEX, DEXAMETHASONE

MAXIPIME, CEFEPIME HYDROCHLORIDE

MAXITROL, DEXAMETHASONE

MAXZIDE, HYDROCHLOROTHIAZIDE

MAXZIDE-25, HYDROCHLOROTHIAZIDE

MD-76R, DIATRIZOATE MEGLUMINE

A - 33

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

MD-GASTROVIEW, DIATRIZOATE MEGLUMINE

MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT

MEBENDAZOLE, MEBENDAZOLE

MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

MEDROL, METHYLPREDNISOLONE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MEFENAMIC ACID, MEFENAMIC ACID

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

MEGACE, MEGESTROL ACETATE

MEGACE ES, MEGESTROL ACETATE

MEGATOPE, ALBUMIN IODINATED I-131 SERUM

MEGESTROL ACETATE, MEGESTROL ACETATE

MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE

MELOXICAM, MELOXICAM

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MEMBRANEBLUE, TRYPAN BLUE

MEN'S ROGAINE, MINOXIDIL

(OTC)

MENEST, ESTROGENS, ESTERIFIED

MENOPUR, MENOTROPINS (FSH

MENOSTAR, ESTRADIOL

MENTAX, BUTENAFINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

MEPHYTON, PHYTONADIONE

MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

MEPROBAMATE, MEPROBAMATE

MEPRON, ATOVAQUONE

MERCAPTOPURINE, MERCAPTOPURINE

MEROPENEM, MEROPENEM

MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER, MEROPENEM

MERREM, MEROPENEM

MESALAMINE, MESALAMINE

MESNA, MESNA

MESNEX, MESNA

MESTINON, PYRIDOSTIGMINE BROMIDE

METADATE CD, METHYLPHENIDATE HYDROCHLORIDE

METADATE ER, METHYLPHENIDATE HYDROCHLORIDE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METARAMINOL BITARTRATE, METARAMINOL BITARTRATE

METASTRON, STRONTIUM CHLORIDE SR-89

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE

METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

METHERGINE, METHYLERGONOVINE MALEATE

METHIMAZOLE, METHIMAZOLE

METHOCARBAMOL, METHOCARBAMOL

METHOCARBAMOL AND ASPIRIN, ASPIRIN

METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOXSALEN, METHOXSALEN

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

METHYCLOTHIAZIDE, METHYCLOTHIAZIDE

METHYLDOPA, METHYLDOPA

METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE

A - 34

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLIN, METHYLPHENIDATE HYDROCHLORIDE

METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOLAZONE, METOLAZONE

METOPIRONE, METYRAPONE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE

METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE

METROCREAM, METRONIDAZOLE

METROGEL, METRONIDAZOLE

METROGEL-VAGINAL, METRONIDAZOLE

METROLOTION, METRONIDAZOLE

METRONIDAZOLE, METRONIDAZOLE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

MIACALCIN, CALCITONIN SALMON

MICARDIS, TELMISARTAN

MICARDIS HCT, HYDROCHLOROTHIAZIDE

MICONAZOLE 3, MICONAZOLE NITRATE

(OTC)

MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MICONAZOLE 7, MICONAZOLE NITRATE

(OTC)

MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE

(OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE

MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MICORT-HC, HYDROCORTISONE ACETATE

MICRO-K, POTASSIUM CHLORIDE

MICRO-K 10, POTASSIUM CHLORIDE

MICROGESTIN 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN 1/20, ETHINYL ESTRADIOL

MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN FE 1/20, ETHINYL ESTRADIOL

MICRONOR, NORETHINDRONE

MICROZIDE, HYDROCHLOROTHIAZIDE

MIDAMOR, AMILORIDE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MIDOL LIQUID GELS, IBUPROFEN

(OTC)

MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MIFEPREX, MIFEPRISTONE

MIGERGOT, CAFFEINE

MIGLITOL, MIGLITOL

MIGRANAL, DIHYDROERGOTAMINE MESYLATE

MILRINONE LACTATE, MILRINONE LACTATE

MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE

MINASTRIN 24 FE, ETHINYL ESTRADIOL

MINIPRESS, PRAZOSIN HYDROCHLORIDE

MINIRIN, DESMOPRESSIN ACETATE

MINITRAN, NITROGLYCERIN

MINIVELLE, ESTRADIOL

MINOCIN, MINOCYCLINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

A - 35

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

MINOXIDIL, MINOXIDIL
(OTC)

MINOXIDIL, MINOXIDIL

MINOXIDIL (FOR MEN), MINOXIDIL

(OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL

(OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL

(OTC)

MIOCHOL-E, ACETYLCHOLINE CHLORIDE

MIOSTAT, CARBACHOL

MIRALAX, POLYETHYLENE GLYCOL 3350

(OTC)

MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE

MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE

MIRENA, LEVONORGESTREL

MIRTAZAPINE, MIRTAZAPINE

MIRVASO, BRIMONIDINE TARTRATE

MISOPROSTOL, MISOPROSTOL

MITIGARE, COLCHICINE

MITOMYCIN, MITOMYCIN

MITOSOL, MITOMYCIN

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MIVACRON, MIVACURIUM CHLORIDE

MOBIC, MELOXICAM

MODAFINIL, MODAFINIL

MODICON 28, ETHINYL ESTRADIOL

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MOEXIPRIL HYDROCHLORIDE AND HYDROCHOLROTHIAZIDE, HYDROCHLOROTHIAZIDE

MOLINDONE HYDROCHLORIDE, MOLINDONE HYDROCHLORIDE

MOMETASONE FUROATE, MOMETASONE FUROATE

MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MONISTAT 3, MICONAZOLE NITRATE

(OTC)

MONISTAT 3, MICONAZOLE NITRATE

MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE

(OTC)

MONISTAT 7, MICONAZOLE NITRATE

(OTC)

MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MONO-LINYAH, ETHINYL ESTRADIOL

MONODOX, DOXYCYCLINE

MONOKET, ISOSORBIDE MONONITRATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MONUROL, FOSFOMYCIN TROMETHAMINE

MORPHABOND, MORPHINE SULFATE

MORPHINE SULFATE, MORPHINE SULFATE

MOTOFEN, ATROPINE SULFATE

MOTRIN IB, IBUPROFEN

(OTC)

MOVANTIK, NALOXEGOL OXALATE

MOVIPREP, ASCORBIC ACID

MOXATAG, AMOXICILLIN

MOXEZA, MOXIFLOXACIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MOZOBIL, PLERIXAFOR

MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT

MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM

MS CONTIN, MORPHINE SULFATE

MUCINEX, GUAIFENESIN
(OTC)

MUCINEX D, GUAIFENESIN
(OTC)

MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE

(OTC)

MULTAQ, DRONEDARONE HYDROCHLORIDE

MULTIHANCE, GADOBENATE DIMEGLUMINE

MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE

MUPIROCIN, MUPIROCIN

MUPIROCIN, MUPIROCIN CALCIUM

MUSE, ALPROSTADIL

MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE

MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE

MYCAMINE, MICAFUNGIN SODIUM

A - 36

A - 37

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

MYCELEX-7, CLOTRIMAZOLE
(OTC)

MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE

(OTC)

MYCOBUTIN, RIFABUTIN

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

MYCOPHENOLIC ACID, MYCOPHENOLIC ACID

MYDRIACYL, TROPICAMIDE

MYFORTIC, MYCOPHENOLIC ACID

MYKACET, NYSTATIN

MYLERAN, BUSULFAN

MYORISAN, ISOTRETINOIN

MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT

MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT

MYRBETRIQ, MIRABEGRON

MYSOLINE, PRIMIDONE

MYZILRA, ETHINYL ESTRADIOL

**

**

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE

NAFCILLIN SODIUM, NAFCILLIN SODIUM

NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE

NAFTIN, NAFTIFINE HYDROCHLORIDE

NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE

NALFON, FENOPROFEN CALCIUM

NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM

NALOXONE, NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NAMENDA, MEMANTINE HYDROCHLORIDE

NAMENDA XR, MEMANTINE HYDROCHLORIDE

NAMZARIC, DONEPEZIL HYDROCHLORIDE

NANDROLONE DECANOATE, NANDROLONE DECANOATE

NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE

NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE
(OTC)

NAPRELAN, NAPROXEN SODIUM

NAPROSYN, NAPROXEN

NAPROXEN, NAPROXEN

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM

(OTC)

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NARCAN, NALOXONE HYDROCHLORIDE

NARDIL, PHENELZINE SULFATE

NAROPIN, ROPIVACAINE HYDROCHLORIDE

NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE

(OTC)

NASCOBAL, CYANOCOBALAMIN

NASONEX, MOMETASONE FUROATE MONOHYDRATE

NATACYN, NATAMYCIN

NATAZIA, DIENOGEST

NATEGLINIDE, NATEGLINIDE

NATESTO, TESTOSTERONE

NATRECOR, NESIRITIDE RECOMBINANT

NATROBA, SPINOSAD

NAVANE, THIOTHIXENE

NAVELBINE, VINORELBINE TARTRATE

NEBUPENT, PENTAMIDINE ISETHIONATE

NEDOCROMIL SODIUM, NEDOCROMIL SODIUM

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

NEMBUTAL SODIUM, PENTOBARBITAL SODIUM

NEO-FRADIN, NEOMYCIN SULFATE

NEO-SYNALAR, FLUOCINOLONE ACETONIDE

(OTC)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NEOPAP, ACETAMINOPHEN
(OTC)

NEOPROFEN, IBUPROFEN LYSINE

NEORAL, CYCLOSPORINE

NEOSPORIN, GRAMICIDIN

NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NEPHRAMINE 5.4%, AMINO ACIDS

NESACAINE, CHLOROPROCAINE HYDROCHLORIDE

NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE

NESINA, ALOGLIPTIN BENZOATE

NEUPRO, ROTIGOTINE

NEURACEQ, FLORBETABEN F-18

NEUROLITE, TECHNETIUM TC-99M BICISATE KIT

NEURONTIN, GABAPENTIN

NEVANAC, NEPAFENAC

NEVIRAPINE, NEVIRAPINE

NEXAVAR, SORAFENIB TOSYLATE

NEXIUM, ESOMEPRAZOLE MAGNESIUM

NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM

(OTC)

NEXIUM IV, ESOMEPRAZOLE SODIUM

NEXPLANON, ETONOGESTREL

NEXTERONE, AMIODARONE HYDROCHLORIDE

NIACIN, NIACIN

NIACOR, NIACIN

NIASPAN, NIACIN

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NICODERM CQ, NICOTINE

(OTC)

NICORETTE, NICOTINE POLACRILEX

(OTC)

NICORETTE (MINT), NICOTINE POLACRILEX

(OTC)

NICOTINE, NICOTINE
(OTC)

NICOTINE POLACRILEX, NICOTINE POLACRILEX

(OTC)

NICOTROL, NICOTINE

NIFEDIPINE, NIFEDIPINE

NIKKI, DROSPIRENONE

NILANDRON, NILUTAMIDE

NIMBEX, CISATRACURIUM BESYLATE

NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE

NIMODIPINE, NIMODIPINE

NINLARO, IXAZOMIB CITRATE

NIPENT, PENTOSTATIN

NISOLDIPINE, NISOLDIPINE

NITHIODOTE, SODIUM NITRITE

NITRO-DUR, NITROGLYCERIN

NITROFURANTOIN, NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROGLYCERIN, NITROGLYCERIN

NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN

NITROLINGUAL PUMPSPRAY, NITROGLYCERIN

NITROMIST, NITROGLYCERIN

NITROPRESS, SODIUM NITROPRUSSIDE

NITROSTAT, NITROGLYCERIN

NIX, PERMETHRIN
(OTC)

NIZATIDINE, NIZATIDINE

NIZORAL, KETOCONAZOLE

NIZORAL A-D, KETOCONAZOLE

(OTC)

NOR-QD, NORETHINDRONE

NORCO, ACETAMINOPHEN

A - 38

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

NORETHINDRONE, NORETHINDRONE

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL

NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL

NORINYL 1+50 28-DAY, MESTRANOL

NORITATE, METRONIDAZOLE

NORMOCARB HF 25, MAGNESIUM CHLORIDE

NORMOCARB HF 35, MAGNESIUM CHLORIDE

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

NORPACE, DISOPYRAMIDE PHOSPHATE

NORPACE CR, DISOPYRAMIDE PHOSPHATE

NORPRAMIN, DESIPRAMINE HYDROCHLORIDE

NORTHERA, DROXIDOPA

NORTREL 0.5/35-28, ETHINYL ESTRADIOL

NORTREL 1/35-21, ETHINYL ESTRADIOL

NORTREL 1/35-28, ETHINYL ESTRADIOL

NORTREL 7/7/7, ETHINYL ESTRADIOL

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NORVASC, AMLODIPINE BESYLATE

NORVIR, RITONAVIR

NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN

(OTC)

NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

(OTC)

NOVOLIN R, INSULIN RECOMBINANT HUMAN

(OTC)

NOVOLOG, INSULIN ASPART RECOMBINANT

NOVOLOG FLEXPEN, INSULIN ASPART RECOMBINANT

NOVOLOG FLEXTOUCH, INSULIN ASPART RECOMBINANT

NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG MIX 70/30 FLEXPEN, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG PENFILL, INSULIN ASPART RECOMBINANT

NOXAFIL, POSACONAZOLE

NUCYNTA, TAPENTADOL HYDROCHLORIDE

NUCYNTA ER, TAPENTADOL HYDROCHLORIDE

NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE

NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350

NUTRACORT, HYDROCORTISONE

NUTRESTORE, GLUTAMINE

NUTRILIPID 10%, SOYBEAN OIL

NUTRILIPID 20%, SOYBEAN OIL

NUTROPIN AQ NUSPIN, SOMATROPIN RECOMBINANT

NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT

NUVARING, ETHINYL ESTRADIOL

NUVESSA, METRONIDAZOLE

NUVIGIL, ARMODAFINIL

NYMALIZE, NIMODIPINE

NYSTATIN, NYSTATIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTOP, NYSTATIN

**

**

OBREDON, GUAIFENESIN

OCTOCAINE, EPINEPHRINE

OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

A - 39

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE

(OTC)

OCUFEN, FLURBIPROFEN SODIUM

OCUFLOX, OFLOXACIN

OCUPRESS, CARTEOLOL HYDROCHLORIDE

ODOMZO, SONIDEGIB PHOSPHATE

OFEV, NINTEDANIB ESYLATE

OFIRMEV, ACETAMINOPHEN

OFLOXACIN, OFLOXACIN

OGEN .625, ESTROPIPATE

OGEN 1.25, ESTROPIPATE

OGEN 2.5, ESTROPIPATE

OGEN 5, ESTROPIPATE

OGESTREL 0.5/50-28, ETHINYL ESTRADIOL

OLANZAPINE, OLANZAPINE

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OLUX, CLOBETASOL PROPIONATE

OLUX E, CLOBETASOL PROPIONATE

OLYSIO, SIMEPREVIR SODIUM

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OMEPRAZOLE, OMEPRAZOLE
(OTC)

OMEPRAZOLE, OMEPRAZOLE

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM

(OTC)

OMIDRIA, KETOROLAC TROMETHAMINE

OMNARIS, CICLESONIDE

OMNIPAQUE 140, IOHEXOL

OMNIPAQUE 180, IOHEXOL

OMNIPAQUE 240, IOHEXOL

OMNIPAQUE 300, IOHEXOL

OMNIPAQUE 350, IOHEXOL

OMNIPRED, PREDNISOLONE ACETATE

OMNISCAN, GADODIAMIDE

OMNITROPE, SOMATROPIN RECOMBINANT

OMTRYG, OMEGA-3-ACID ETHYL ESTERS

ONDANSETRON, ONDANSETRON

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONEXTON, BENZOYL PEROXIDE

ONFI, CLOBAZAM

ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE

ONIVYDE, IRINOTECAN HYDROCHLORIDE

ONMEL, ITRACONAZOLE

OPANA, OXYMORPHONE HYDROCHLORIDE

OPANA ER, OXYMORPHONE HYDROCHLORIDE

OPCICON ONE-STEP, LEVONORGESTREL

(OTC)

OPCON-A, NAPHAZOLINE HYDROCHLORIDE

(OTC)

OPSUMIT, MACITENTAN

OPTIMARK, GADOVERSETAMIDE

OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE

OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

OPTIRAY 240, IOVERSOL

OPTIRAY 300, IOVERSOL

OPTIRAY 320, IOVERSOL

OPTIRAY 350, IOVERSOL

OPTISON, ALBUMIN HUMAN

OPTIVAR, AZELASTINE HYDROCHLORIDE

ORABLOC, ARTICAINE HYDROCHLORIDE

ORACEA, DOXYCYCLINE

ORALTAG, IOHEXOL

ORAP, PIMOZIDE

ORAPRED, PREDNISOLONE SODIUM PHOSPHATE

ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE

ORAQIX, LIDOCAINE

A - 40

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ORAVERSE, PHENTOLAMINE MESYLATE

ORAVIG, MICONAZOLE

ORBACTIV, ORITAVANCIN DIPHOSPHATE

ORENITRAM, TREPROSTINIL DIOLAMINE

ORETIC, HYDROCHLOROTHIAZIDE

ORFADIN, NITISINONE

ORKAMBI, IVACAFTOR

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

ORSYTHIA, ETHINYL ESTRADIOL

ORTHO CYCLEN-28, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL

ORTHO-CEPT, DESOGESTREL

ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL

ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL

ORVATEN, MIDODRINE HYDROCHLORIDE

OSENI, ALOGLIPTIN BENZOATE

OSMITROL 10% IN WATER, MANNITOL

OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 15% IN WATER, MANNITOL

OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 20% IN WATER, MANNITOL

OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 5% IN WATER, MANNITOL

OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

OSPHENA, OSPEMIFENE

OTEZLA, APREMILAST

OTICAIR, HYDROCORTISONE

OTIPRIO, CIPROFLOXACIN

OTREXUP, METHOTREXATE

OVIDE, MALATHION

OVIDREL, CHORIOGONADOTROPIN ALFA

OXACILLIN SODIUM, OXACILLIN SODIUM

OXALIPLATIN, OXALIPLATIN

OXANDRIN, OXANDROLONE

OXANDROLONE, OXANDROLONE

OXAPROZIN, OXAPROZIN

OXAYDO, OXYCODONE HYDROCHLORIDE

OXAZEPAM, OXAZEPAM

OXCARBAZEPINE, OXCARBAZEPINE

OXILAN-300, IOXILAN

OXILAN-350, IOXILAN

OXISTAT, OXICONAZOLE NITRATE

OXSORALEN, METHOXSALEN

OXSORALEN-ULTRA, METHOXSALEN

OXTELLAR XR, OXCARBAZEPINE

OXYBUTYNIN, OXYBUTYNIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCET, ACETAMINOPHEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE AND ASPIRIN, ASPIRIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

OXYCONTIN, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

OXYTOCIN, OXYTOCIN

OXYTROL, OXYBUTYNIN

OXYTROL FOR WOMEN, OXYBUTYNIN

(OTC)

OZURDEX, DEXAMETHASONE

**
PACERONE,

AMIODARONE HYDROCHLORIDE

**

A - 41

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 42

PRODUCT NAME INDEX

**

**

PACLITAXEL, PACLITAXEL

PALIPERIDONE, PALIPERIDONE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAMELOR, NORTRIPTYLINE HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCREAZE, PANCRELIPASE (AMYLASE

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PANDEL, HYDROCORTISONE PROBUTATE

PANRETIN, ALITRETINOIN

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARAGARD T 380A, COPPER

PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE

PARICALCITOL, PARICALCITOL

PARLODEL, BROMOCRIPTINE MESYLATE

PARNATE, TRANYLCYPROMINE SULFATE

PAROEX, CHLORHEXIDINE GLUCONATE

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

PAROXETINE, PAROXETINE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PASER, AMINOSALICYLIC ACID

PATADAY, OLOPATADINE HYDROCHLORIDE

PATANASE, OLOPATADINE HYDROCHLORIDE

PATANOL, OLOPATADINE HYDROCHLORIDE

PAXIL, PAROXETINE HYDROCHLORIDE

PAXIL CR, PAROXETINE HYDROCHLORIDE

PAZEO, OLOPATADINE HYDROCHLORIDE

PCE, ERYTHROMYCIN

PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE

PEDIATRIC ADVIL, IBUPROFEN

(OTC)

PEDIOTIC, HYDROCORTISONE

PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL, BISACODYL

PEGANONE, ETHOTOIN

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM

PENICILLIN G PROCAINE, PENICILLIN G PROCAINE

PENICILLIN G SODIUM, PENICILLIN G SODIUM

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PENICILLIN-VK, PENICILLIN V POTASSIUM

PENLAC, CICLOPIROX

PENNSAID, DICLOFENAC SODIUM

PENTAM, PENTAMIDINE ISETHIONATE

PENTASA, MESALAMINE

PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE

PENTOSTATIN, PENTOSTATIN

PENTOXIFYLLINE, PENTOXIFYLLINE

PENTOXIL, PENTOXIFYLLINE

PEPCID, FAMOTIDINE

PEPCID AC, FAMOTIDINE

(OTC)

PEPCID AC , FAMOTIDINE
(OTC)

PEPCID COMPLETE, CALCIUM CARBONATE

(OTC)

PERCOCET, ACETAMINOPHEN

PERCODAN, ASPIRIN

PERFOROMIST, FORMOTEROL FUMARATE

PERIDEX, CHLORHEXIDINE GLUCONATE

PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

PERIOCHIP, CHLORHEXIDINE GLUCONATE

PERIOGARD, CHLORHEXIDINE GLUCONATE

PERMAPEN, PENICILLIN G BENZATHINE

PERMETHRIN, PERMETHRIN
(OTC)

PERMETHRIN, PERMETHRIN

PERPHENAZINE, PERPHENAZINE

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 43

PRODUCT NAME INDEX

**

**

PERSANTINE, DIPYRIDAMOLE

PERTZYE, PANCRELIPASE (AMYLASE

PEXEVA, PAROXETINE MESYLATE

PFIZERPEN, PENICILLIN G POTASSIUM

PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE

(OTC)

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENELZINE SULFATE, PHENELZINE SULFATE

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX

PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PHENYTEK, PHENYTOIN SODIUM

PHENYTOIN, PHENYTOIN

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PHILITH, ETHINYL ESTRADIOL

PHISOHEX, HEXACHLOROPHENE

PHOSLO GELCAPS, CALCIUM ACETATE

PHOSLYRA, CALCIUM ACETATE

PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE

PHOTOFRIN, PORFIMER SODIUM

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PHYTONADIONE, PHYTONADIONE

PICATO, INGENOL MEBUTATE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PIMOZIDE, PIMOZIDE

PIMTREA, DESOGESTREL

PINDOLOL, PINDOLOL

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIPERACILLIN, PIPERACILLIN SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PIRMELLA 1/35, ETHINYL ESTRADIOL

PIRMELLA 7/7/7, ETHINYL ESTRADIOL

PIROXICAM, PIROXICAM

PITOCIN, OXYTOCIN

PLAN B, LEVONORGESTREL
(OTC)

PLAN B, LEVONORGESTREL

PLAN B ONE-STEP, LEVONORGESTREL

(OTC)

PLAQUENIL, HYDROXYCHLOROQUINE SULFATE

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLAVIX, CLOPIDOGREL BISULFATE

PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PLETAL, CILOSTAZOL

PLIAGLIS, LIDOCAINE

PODOFILOX, PODOFILOX

POLOCAINE, MEPIVACAINE HYDROCHLORIDE

POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

(OTC)

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

POLYMYCIN B SULFATE, POLYMYXIN B SULFATE

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

POLYTRIM, POLYMYXIN B SULFATE

POMALYST, POMALIDOMIDE

PONSTEL, MEFENAMIC ACID

PORTIA-28, ETHINYL ESTRADIOL

POTASSIUM ACETATE, POTASSIUM ACETATE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM

CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE

A - 44

**

0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE

0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 45

PRODUCT NAME INDEX

**

**

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

POTIGA, EZOGABINE

POVIDONE IODINE, POVIDONE-IODINE

(OTC)

PRADAXA, DABIGATRAN ETEXILATE MESYLATE

PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAMOSONE, HYDROCORTISONE ACETATE

PRANDIMET, METFORMIN HYDROCHLORIDE

PRANDIN, REPAGLINIDE

PRAVACHOL, PRAVASTATIN SODIUM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PRE-OP, HEXACHLOROPHENE

PRE-OP II, HEXACHLOROPHENE

PRE-PEN, BENZYLPENICILLOYL POLYLYSINE

PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE

PRECOSE, ACARBOSE

PRED FORTE, PREDNISOLONE ACETATE

PRED MILD, PREDNISOLONE ACETATE

PRED-G, GENTAMICIN SULFATE

PREDNICARBATE, PREDNICARBATE

PREDNISOLONE, PREDNISOLONE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISONE, PREDNISONE

PREDNISONE INTENSOL, PREDNISONE

PREGNYL, GONADOTROPIN, CHORIONIC

PRELONE, PREDNISOLONE

PREMARIN, ESTROGENS, CONJUGATED

PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 46

PRODUCT NAME INDEX

**

**

PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS

PREMPHASE 14/14, ESTROGENS, CONJUGATED

PREMPRO, ESTROGENS, CONJUGATED

PREPIDIL, DINOPROSTONE

PREPOPIK, CITRIC ACID

PRESTALIA, AMLODIPINE BESYLATE

PREVACID, LANSOPRAZOLE

PREVACID 24 HR, LANSOPRAZOLE

(OTC)

PREVALITE, CHOLESTYRAMINE

PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE

(OTC)

PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE

(OTC)

PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE

(OTC)

PREVIFEM, ETHINYL ESTRADIOL

PREVPAC, AMOXICILLIN

PREZCOBIX, COBICISTAT

PREZISTA, DARUNAVIR ETHANOLATE

PRIALT, ZICONOTIDE ACETATE

PRIFTIN, RIFAPENTINE

PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE

PRILOSEC, OMEPRAZOLE

PRILOSEC, OMEPRAZOLE MAGNESIUM

PRILOSEC OTC, OMEPRAZOLE MAGNESIUM

(OTC)

PRIMAQUINE, PRIMAQUINE PHOSPHATE

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

PRIMAXIN, CILASTATIN SODIUM

PRIMIDONE, PRIMIDONE

PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE

PRINIVIL, LISINOPRIL

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISTIQ, DESVENLAFAXINE SUCCINATE

PROAIR HFA, ALBUTEROL SULFATE

PROAIR RESPICLICK, ALBUTEROL SULFATE

PROBALAN, PROBENECID

PROBENECID, PROBENECID

PROBENECID AND COLCHICINE, COLCHICINE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

PROCALAMINE, AMINO ACIDS

PROCARDIA, NIFEDIPINE

PROCARDIA XL, NIFEDIPINE

PROCHLORPERAZINE, PROCHLORPERAZINE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROCOMP, PROCHLORPERAZINE MALEATE

PROCTOFOAM HC, HYDROCORTISONE ACETATE

PROCYSBI, CYSTEAMINE BITARTRATE

PROFEN, IBUPROFEN
(OTC)

PROFERDEX, IRON DEXTRAN

PROGESTERONE, PROGESTERONE

PROGLYCEM, DIAZOXIDE

PROGRAF, TACROLIMUS

PROHANCE, GADOTERIDOL

PROHANCE MULTIPACK, GADOTERIDOL

PROLENSA, BROMFENAC SODIUM

PROMACTA, ELTROMBOPAG OLAMINE

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

A - 47

PRODUCT NAME INDEX

**

**

PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE

PROMETH VC W/ CODEINE, CODEINE PHOSPHATE

PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE

PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE

PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE

PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE

PROMETRIUM, PROGESTERONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

PROPECIA, FINASTERIDE

PROPOFOL, PROPOFOL

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

PROSCAR, FINASTERIDE

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

PROSTIN E2, DINOPROSTONE

PROSTIN VR PEDIATRIC, ALPROSTADIL

PROTAMINE SULFATE, PROTAMINE SULFATE

PROTONIX, PANTOPRAZOLE SODIUM

PROTONIX IV, PANTOPRAZOLE SODIUM

PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE

PROTOPIC, TACROLIMUS

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

PROVENTIL-HFA, ALBUTEROL SULFATE

PROVERA, MEDROXYPROGESTERONE ACETATE

PROVIGIL, MODAFINIL

PROVOCHOLINE, METHACHOLINE CHLORIDE

PROZAC, FLUOXETINE HYDROCHLORIDE

PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

(OTC)

PULMICORT FLEXHALER, BUDESONIDE

PULMICORT RESPULES, BUDESONIDE

PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

PUR-WASH, PURIFIED WATER

(OTC)

PURIXAN, MERCAPTOPURINE

PYLERA, BISMUTH SUBCITRATE POTASSIUM

PYRAZINAMIDE, PYRAZINAMIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE

PYTEST, UREA, C-14

PYTEST KIT, UREA, C-14

**

**

QNASL, BECLOMETHASONE DIPROPIONATE

QOLIANA, BRIMONIDINE TARTRATE

QSYMIA, PHENTERMINE HYDROCHLORIDE

QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

QUALAQUIN, QUININE SULFATE

QUARTETTE, ETHINYL ESTRADIOL

QUASENSE, ETHINYL ESTRADIOL

QUDEXY XR, TOPIRAMATE

QUELICIN, SUCCINYLCHOLINE CHLORIDE

QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUILLICHEW ER, METHYLPHENIDATE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINARETIC, HYDROCHLOROTHIAZIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

QUINIDINE SULFATE, QUINIDINE SULFATE

QUININE SULFATE, QUININE SULFATE

QUTENZA, CAPSAICIN

QVAR 40, BECLOMETHASONE DIPROPIONATE

QVAR 80, BECLOMETHASONE DIPROPIONATE

**

**

R-GENE 10, ARGININE HYDROCHLORIDE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RAMELTEON, RAMELTEON

RAMIPRIL, RAMIPRIL

RANEXA, RANOLAZINE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANOLAZINE, RANOLAZINE

RAPAFLO, SILODOSIN

RAPAMUNE, SIROLIMUS

RAPIVAB, PERAMIVIR

RASAGILINE MESYLATE, RASAGILINE MESYLATE

RASUVO, METHOTREXATE

RAVICTI, GLYCEROL PHENYLBUTYRATE

RAYOS, PREDNISONE

RAZADYNE, GALANTAMINE HYDROBROMIDE

RAZADYNE ER, GALANTAMINE HYDROBROMIDE

REBETOL, RIBAVIRIN

RECLAST, ZOLEDRONIC ACID

RECTIV, NITROGLYCERIN

REGITINE, PHENTOLAMINE MESYLATE

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE

REGONOL, PYRIDOSTIGMINE BROMIDE

RELENZA, ZANAMIVIR

RELISTOR, METHYLNALTREXONE BROMIDE

RELPAX, ELETRIPTAN HYDROBROMIDE

REMERON, MIRTAZAPINE

REMERON SOLTAB, MIRTAZAPINE

REMODULIN, TREPROSTINIL

RENACIDIN, CITRIC ACID

RENAGEL, SEVELAMER HYDROCHLORIDE

RENOGRAFIN-76, DIATRIZOATE MEGLUMINE

RENOVA, TRETINOIN

RENVELA, SEVELAMER CARBONATE

REPAGLINIDE, REPAGLINIDE

REPAGLINIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

REPREXAIN, HYDROCODONE BITARTRATE

REQUIP, ROPINIROLE HYDROCHLORIDE

REQUIP XL, ROPINIROLE HYDROCHLORIDE

RESCRIPTOR, DELAVIRDINE MESYLATE

RESCULA, UNOPROSTONE ISOPROPYL

RESECTISOL IN PLASTIC CONTAINER, MANNITOL

RESERPINE, RESERPINE

RESTASIS, CYCLOSPORINE

RESTORIL, TEMAZEPAM

RETIN-A, TRETINOIN

RETIN-A MICRO, TRETINOIN

RETIN-A-MICRO, TRETINOIN

RETISERT, FLUOCINOLONE ACETONIDE

RETROVIR, ZIDOVUDINE

REVATIO, SILDENAFIL CITRATE

A - 48

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

REVIA, NALTREXONE HYDROCHLORIDE

REVLIMID, LENALIDOMIDE

REVONTO, DANTROLENE SODIUM

REXULTI, BREXPIPRAZOLE

REYATAZ, ATAZANAVIR SULFATE

REZIRA, HYDROCODONE BITARTRATE

RHINOCORT ALLERGY, BUDESONIDE

(OTC)

RIBASPHERE, RIBAVIRIN

RIBAVARIN, RIBAVIRIN

RIBAVIRIN, RIBAVIRIN

RIDAURA, AURANOFIN

RIFABUTIN, RIFABUTIN

RIFADIN, RIFAMPIN

RIFAMATE, ISONIAZID

RIFAMPIN, RIFAMPIN

RIFATER, ISONIAZID

RILUTEK, RILUZOLE

RILUZOLE, RILUZOLE

RIMACTANE, RIFAMPIN

RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE

RIMSO-50, DIMETHYL SULFOXIDE

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

RIOMET, METFORMIN HYDROCHLORIDE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RISPERDAL, RISPERIDONE

RISPERDAL CONSTA, RISPERIDONE

RISPERIDONE, RISPERIDONE

RITALIN, METHYLPHENIDATE HYDROCHLORIDE

RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE

RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE

RITONAVIR, RITONAVIR

RIVASTIGMINE, RIVASTIGMINE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROBAXIN, METHOCARBAMOL

ROBAXIN-750, METHOCARBAMOL

ROBINUL, GLYCOPYRROLATE

ROBINUL FORTE, GLYCOPYRROLATE

ROCALTROL, CALCITRIOL

ROCEPHIN, CEFTRIAXONE SODIUM

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROGAINE (FOR MEN), MINOXIDIL

(OTC)

ROGAINE (FOR WOMEN), MINOXIDIL

(OTC)

ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL

(OTC)

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

ROSIGLITAZONE MALEATE, ROSIGLITAZONE MALEATE

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ROWASA, MESALAMINE

ROXICET, ACETAMINOPHEN

ROXICODONE, OXYCODONE HYDROCHLORIDE

ROZEREM, RAMELTEON

RYANODEX, DANTROLENE SODIUM

RYTARY, CARBIDOPA

RYTHMOL, PROPAFENONE HYDROCHLORIDE

RYTHMOL SR, PROPAFENONE HYDROCHLORIDE

RYZODEG 70/30, INSULIN ASPART

**
SABRIL, VIGABATRIN

SAFYRAL, DROSPIRENONE

SAIZEN, SOMATROPIN RECOMBINANT

SALAGEN, PILOCARPINE HYDROCHLORIDE

SALONPAS, MENTHOL
(OTC)

SALURON, HYDROFLUMETHIAZIDE

**

A - 49

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

SAMSCA, TOLVAPTAN

SANCUSO, GRANISETRON

SANDIMMUNE, CYCLOSPORINE

SANDOSTATIN, OCTREOTIDE ACETATE

SANDOSTATIN LAR, OCTREOTIDE ACETATE

SAPHRIS, ASENAPINE MALEATE

SARAFEM, FLUOXETINE HYDROCHLORIDE

SAVAYSA, EDOXABAN TOSYLATE

SAVELLA, MILNACIPRAN HYDROCHLORIDE

SAXENDA, LIRAGLUTIDE RECOMBINANT

SCANDONEST L, LEVONORDEFRIN

SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE

SCANLUX-300, IOPAMIDOL

SCANLUX-370, IOPAMIDOL

SCLEROSOL, TALC

SCOPOLAMINE, SCOPOLAMINE

SEASONALE, ETHINYL ESTRADIOL

SEASONIQUE, ETHINYL ESTRADIOL

SECONAL SODIUM, SECOBARBITAL SODIUM

SECTRAL, ACEBUTOLOL HYDROCHLORIDE

SEEBRI, GLYCOPYRROLATE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SELENIUM SULFIDE, SELENIUM SULFIDE

SELFEMRA, FLUOXETINE HYDROCHLORIDE

SELSUN, SELENIUM SULFIDE

SELZENTRY, MARAVIROC

SEMPREX-D, ACRIVASTINE

SENSIPAR, CINACALCET HYDROCHLORIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

SEPTOCAINE, ARTICAINE HYDROCHLORIDE

SEPTRA, SULFAMETHOXAZOLE

SEPTRA DS, SULFAMETHOXAZOLE

SEREVENT, SALMETEROL XINAFOATE

SEROMYCIN, CYCLOSERINE

SEROQUEL, QUETIAPINE FUMARATE

SEROQUEL XR, QUETIAPINE FUMARATE

SEROSTIM, SOMATROPIN RECOMBINANT

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SETLAKIN, ETHINYL ESTRADIOL

SEVOFLURANE, SEVOFLURANE

SFROWASA, MESALAMINE

SHADE UVAGUARD, AVOBENZONE

(OTC)

SIGNIFOR, PASIREOTIDE DIASPARTATE

SIGNIFOR LAR, PASIREOTIDE PAMOATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILENOR, DOXEPIN HYDROCHLORIDE

SILVADENE, SILVER SULFADIAZINE

SIMBRINZA, BRIMONIDINE TARTRATE

SIMCOR, NIACIN

SIMVASTATIN, SIMVASTATIN

SINE-AID IB, IBUPROFEN

(OTC)

SINEMET, CARBIDOPA

SINEMET CR, CARBIDOPA

SINGULAIR, MONTELUKAST SODIUM

SINOGRAFIN, DIATRIZOATE MEGLUMINE

SIROLIMUS, SIROLIMUS

SIRTURO, BEDAQUILINE FUMARATE

SITAVIG, ACYCLOVIR

SIVEXTRO, TEDIZOLID PHOSPHATE

SKELAXIN, METAXALONE

SKLICE, IVERMECTIN

SKYLA, LEVONORGESTREL

SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS

SODIUM BICARBONATE, SODIUM BICARBONATE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

A - 50

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% , SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

SODIUM IODIDE I 123, SODIUM IODIDE I-123

SODIUM IODIDE I 131, SODIUM IODIDE I-131

SODIUM IODIDE I-131, SODIUM IODIDE I-131

SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE

SODIUM NITRITE, SODIUM NITRITE

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

SODIUM THIOSULFATE, SODIUM THIOSULFATE

SOJOURN, SEVOFLURANE

SOLARAZE, DICLOFENAC SODIUM

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

SOLODYN, MINOCYCLINE HYDROCHLORIDE

SOLTAMOX, TAMOXIFEN CITRATE

SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE

SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE

SOMA, CARISOPRODOL

SOMA COMPOUND, ASPIRIN

SOMA COMPOUND W/ CODEINE, ASPIRIN

SOMATULINE DEPOT, LANREOTIDE ACETATE

SOMAVERT, PEGVISOMANT

SONATA, ZALEPLON

SOOLANTRA, IVERMECTIN

SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL

SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL

SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL

SORIATANE, ACITRETIN

SORILUX, CALCIPOTRIENE

SORINE, SOTALOL HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SOTRADECOL, SODIUM TETRADECYL SULFATE

SOTRET, ISOTRETINOIN

SOTYLIZE, SOTALOL HYDROCHLORIDE

SOVALDI, SOFOSBUVIR

SPECTRACEF, CEFDITOREN PIVOXIL

SPIRIVA, TIOTROPIUM BROMIDE

SPIRIVA RESPIMAT, TIOTROPIUM BROMIDE

SPIRONOLACTONE, SPIRONOLACTONE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPORANOX, ITRACONAZOLE

SPRINTEC, ETHINYL ESTRADIOL

SPRITAM, LEVETIRACETAM

SPRIX, KETOROLAC TROMETHAMINE

SPRYCEL, DASATINIB

SPS, SODIUM POLYSTYRENE SULFONATE

SSD, SILVER SULFADIAZINE

SSD AF, SILVER SULFADIAZINE

STALEVO 100, CARBIDOPA

STALEVO 125, CARBIDOPA

STALEVO 150, CARBIDOPA

STALEVO 200, CARBIDOPA

STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA

STARLIX, NATEGLINIDE

STAVUDINE, STAVUDINE

STAXYN, VARDENAFIL HYDROCHLORIDE

A - 51

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

STENDRA, AVANAFIL

STERILE WATER, STERILE WATER FOR IRRIGATION

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

STIE-CORT, HYDROCORTISONE

STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

STIOLTO RESPIMAT, OLODATEROL HYDROCHLORIDE

STIVARGA, REGORAFENIB

STRATTERA, ATOMOXETINE HYDROCHLORIDE

STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE

STRIANT, TESTOSTERONE

STRIBILD, COBICISTAT

STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE

STROMECTOL, IVERMECTIN

STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89

SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE

SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

SUBSYS, FENTANYL

SUCRAID, SACROSIDASE

SUCRALFATE, SUCRALFATE

SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE

(OTC)

SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE

(OTC)

SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE

SUFENTANIL CITRATE, SUFENTANIL CITRATE

SULAR, NISOLDIPINE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

SULFADIAZINE, SULFADIAZINE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE

SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE

SULFAMYLON, MAFENIDE ACETATE

SULFASALAZINE, SULFASALAZINE

SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

SULINDAC, SULINDAC

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE

SUNITINIB MALATE, SUNITINIB MALATE

SUPPRELIN LA, HISTRELIN ACETATE

SUPRANE, DESFLURANE

SUPRAX, CEFIXIME

SUPRENZA, PHENTERMINE HYDROCHLORIDE

SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS

SURMONTIL, TRIMIPRAMINE MALEATE

SURVANTA, BERACTANT

SUSTIVA, EFAVIRENZ

SUTENT, SUNITINIB MALATE

SYEDA, DROSPIRENONE

SYMBICORT, BUDESONIDE

SYMBYAX, FLUOXETINE HYDROCHLORIDE

SYMLIN, PRAMLINTIDE ACETATE

SYNACORT, HYDROCORTISONE

SYNALAR, FLUOCINOLONE ACETONIDE

SYNALGOS-DC, ASPIRIN

SYNAREL, NAFARELIN ACETATE

SYNERA, LIDOCAINE

SYNERCID, DALFOPRISTIN

SYNJARDY, EMPAGLIFLOZIN

SYNRIBO, OMACETAXINE MEPESUCCINATE

SYNTHROID, LEVOTHYROXINE SODIUM **

SYPRINE, TRIENTINE HYDROCHLORIDE

**
TAB-PROFEN,

IBUPROFEN

(OTC)

**

A - 52

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

TACLONEX, BETAMETHASONE DIPROPIONATE

TACROLIMUS, TACROLIMUS

TAFINLAR, DABRAFENIB MESYLATE

TAGAMET HB, CIMETIDINE

(OTC)

TAGRISSO, OSIMERTINIB MESYLATE

TALC, TALC

TALWIN, PENTAZOCINE LACTATE

TAMIFLU, OSELTAMIVIR PHOSPHATE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TAPAZOLE, METHIMAZOLE

TARCEVA, ERLOTINIB HYDROCHLORIDE

TARGRETIN, BEXAROTENE

TARKA, TRANDOLAPRIL

TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE

TASMAR, TOLCAPONE

TAVIST-1, CLEMASTINE FUMARATE

(OTC)

TAXOL, PACLITAXEL

TAXOTERE, DOCETAXEL

TAZICEF, CEFTAZIDIME

TAZORAC, TAZAROTENE

TAZTIA XT, DILTIAZEM HYDROCHLORIDE

TECFIDERA, DIMETHYL FUMARATE

TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT

TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT

TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

TECHNETIUM TC 99M GENERATOR, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

TECHNETIUM TC-99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNIVIE, OMBITASVIR

TEFLARO, CEFTAROLINE FOSAMIL

TEGRETOL, CARBAMAZEPINE

TEGRETOL-XR, CARBAMAZEPINE

TEKTURNA, ALISKIREN HEMIFUMARATE

TEKTURNA HCT, ALISKIREN HEMIFUMARATE

TELMISARTAN, TELMISARTAN

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TEMAZEPAM, TEMAZEPAM

TEMODAR, TEMOZOLOMIDE

TEMOVATE, CLOBETASOL PROPIONATE

TEMOZOLOMIDE, TEMOZOLOMIDE

TENEX, GUANFACINE HYDROCHLORIDE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TENORETIC 100, ATENOLOL

TENORETIC 50, ATENOLOL

TENORMIN, ATENOLOL

TENUATE, DIETHYLPROPION HYDROCHLORIDE

TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE

TERAZOL 3, TERCONAZOLE

TERAZOL 7, TERCONAZOLE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

(OTC)

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TERCONAZOLE, TERCONAZOLE

TERIL, CARBAMAZEPINE

TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE

TESSALON, BENZONATATE

TESTIM, TESTOSTERONE

TESTOPEL, TESTOSTERONE

TESTOSTERONE, TESTOSTERONE

A - 53

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

TESTRED, METHYLTESTOSTERONE

TETRABENAZINE, TETRABENAZINE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

TEVETEN, EPROSARTAN MESYLATE

TEXACORT, HYDROCORTISONE

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

THALOMID, THALIDOMIDE

THAM, TROMETHAMINE

THEO-24, THEOPHYLLINE

THEOCHRON, THEOPHYLLINE

THEOPHYLLINE, THEOPHYLLINE

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THERMAZENE, SILVER SULFADIAZINE

THEROXIDIL, MINOXIDIL
(OTC)

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

THIOGUANINE, THIOGUANINE

THIOLA, TIOPRONIN

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

THIOTEPA, THIOTEPA

THIOTHIXENE, THIOTHIXENE

THRIVE, NICOTINE POLACRILEX

(OTC)

THYROGEN, THYROTROPIN ALFA

THYROLAR-0.25, LIOTRIX (T4

THYROLAR-0.5, LIOTRIX (T4

THYROLAR-1, LIOTRIX (T4

THYROLAR-2, LIOTRIX (T4

THYROLAR-3, LIOTRIX (T4

THYROSAFE, POTASSIUM IODIDE

(OTC)

THYROSHIELD, POTASSIUM IODIDE

(OTC)

TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

TIAZAC, DILTIAZEM HYDROCHLORIDE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TIGECYCLINE, TIGECYCLINE

TIKOSYN, DOFETILIDE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIMOPTIC, TIMOLOL MALEATE

TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE

TIMOPTIC-XE, TIMOLOL MALEATE

TINDAMAX, TINIDAZOLE

TINIDAZOLE, TINIDAZOLE

TIOCONAZOLE, TIOCONAZOLE
(OTC)

TIROSINT, LEVOTHYROXINE SODIUM

TIS-U-SOL, MAGNESIUM SULFATE

TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE

TIVICAY, DOLUTEGRAVIR SODIUM

TIVORBEX, INDOMETHACIN

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOBI, TOBRAMYCIN

TOBI PODHALER, TOBRAMYCIN

TOBRADEX, DEXAMETHASONE

TOBRADEX ST, DEXAMETHASONE

TOBRAMYCIN, TOBRAMYCIN

TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE

TOBREX, TOBRAMYCIN

TODAY, NONOXYNOL-9
(OTC)

A - 54

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

TOFRANIL, IMIPRAMINE HYDROCHLORIDE

TOFRANIL-PM, IMIPRAMINE PAMOATE

TOLAK, FLUOROURACIL

TOLAZAMIDE, TOLAZAMIDE

TOLBUTAMIDE, TOLBUTAMIDE

TOLCAPONE, TOLCAPONE

TOLMETIN SODIUM, TOLMETIN SODIUM

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TOPAMAX, TOPIRAMATE

TOPICORT, DESOXIMETASONE

TOPIRAMATE, TOPIRAMATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TOPROL-XL, METOPROLOL SUCCINATE

TORISEL, TEMSIROLIMUS

TORSEMIDE, TORSEMIDE

TOTECT, DEXRAZOXANE HYDROCHLORIDE

TOUJEO SOLOSTAR, INSULIN GLARGINE RECOMBINANT

TOVIAZ, FESOTERODINE FUMARATE

TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE

TRACLEER, BOSENTAN

TRADJENTA, LINAGLIPTIN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRANDATE, LABETALOL HYDROCHLORIDE

TRANDOLAPRIL, TRANDOLAPRIL

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL

TRANEXAMIC ACID, TRANEXAMIC ACID

TRANSDERM SCOP, SCOPOLAMINE

TRANXENE, CLORAZEPATE DIPOTASSIUM

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVATAN Z, TRAVOPROST

TRAVOPROST, TRAVOPROST

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRECATOR, ETHIONAMIDE

TRELSTAR, TRIPTORELIN PAMOATE

TRESIBA, INSULIN DEGLUDEC

TRETINOIN, TRETINOIN

TREXALL, METHOTREXATE SODIUM

TREXIMET, NAPROXEN SODIUM

TREZIX, ACETAMINOPHEN

TRI LO SPRINTEC, ETHINYL ESTRADIOL

TRI-ESTARYLLA, ETHINYL ESTRADIOL

TRI-LEGEST 21, ETHINYL ESTRADIOL

TRI-LEGEST FE, ETHINYL ESTRADIOL

TRI-LINYAH, ETHINYL ESTRADIOL

TRI-LO-ESTARYLLA, ETHINYL ESTRADIOL

TRI-LUMA, FLUOCINOLONE ACETONIDE

TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL

TRI-PREVIFEM, ETHINYL ESTRADIOL

TRI-SPRINTEC, ETHINYL ESTRADIOL

TRIACIN-C, CODEINE PHOSPHATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIAZOLAM, TRIAZOLAM

TRIBENZOR, AMLODIPINE BESYLATE

TRICOR, FENOFIBRATE

TRIDERM, TRIAMCINOLONE ACETONIDE

TRIDIONE, TRIMETHADIONE

TRIESENCE, TRIAMCINOLONE ACETONIDE

TRIFERIC, FERRIC PYROPHOSPHATE CITRATE

A - 55

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

TRIFLURIDINE, TRIFLURIDINE

TRIGLIDE, FENOFIBRATE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

TRILEPTAL, OXCARBAZEPINE

TRILIPIX, CHOLINE FENOFIBRATE

TRILYTE, POLYETHYLENE GLYCOL 3350

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOPRIM, TRIMETHOPRIM

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

TRIOSTAT, LIOTHYRONINE SODIUM

TRISENOX, ARSENIC TRIOXIDE

TRIUMEQ, ABACAVIR SULFATE

TRIVAGIZOLE 3, CLOTRIMAZOLE
(OTC)

TRIVORA-28, ETHINYL ESTRADIOL

TRIZIVIR, ABACAVIR SULFATE

TROKENDI XR, TOPIRAMATE

TROPHAMINE, AMINO ACIDS

TROPHAMINE 10%, AMINO ACIDS

TROPICACYL, TROPICAMIDE

TROPICAMIDE, TROPICAMIDE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

TRUVADA, EMTRICITABINE

TUDORZA PRESSAIR, ACLIDINIUM BROMIDE

TUSSICAPS, CHLORPHENIRAMINE POLISTIREX

TUSSIGON, HOMATROPINE METHYLBROMIDE

TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX

TUZISTRA XR, CHLORPHENIRAMINE POLISTIREX

TWINJECT 0.15, EPINEPHRINE

TWINJECT 0.3, EPINEPHRINE

TWYNSTA, AMLODIPINE BESYLATE

TYBOST, COBICISTAT

TYGACIL, TIGECYCLINE

TYKERB, LAPATINIB DITOSYLATE

TYLENOL , ACETAMINOPHEN
(OTC)

TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN

TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN

TYVASO, TREPROSTINIL

TYZEKA, TELBIVUDINE

TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

**

**

U-CORT, HYDROCORTISONE ACETATE

UCERIS, BUDESONIDE

ULESFIA, BENZYL ALCOHOL

ULORIC, FEBUXOSTAT

ULTANE, SEVOFLURANE

ULTIVA, REMIFENTANIL HYDROCHLORIDE

ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

ULTRACET, ACETAMINOPHEN

ULTRAM, TRAMADOL HYDROCHLORIDE

ULTRAM ER, TRAMADOL HYDROCHLORIDE

ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT

ULTRAVATE, HALOBETASOL PROPIONATE

ULTRAVIST (PHARMACY BULK), IOPROMIDE

ULTRAVIST 150, IOPROMIDE

ULTRAVIST 240, IOPROMIDE

ULTRAVIST 300, IOPROMIDE

ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE

ULTRAVIST 370, IOPROMIDE

ULTRESA, PANCRELIPASE (AMYLASE

UNASYN, AMPICILLIN SODIUM

A - 56

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

**

UNIPHYL, THEOPHYLLINE

UNIRETIC, HYDROCHLOROTHIAZIDE

UNISOM, DOXYLAMINE SUCCINATE

(OTC)

UNITHROID, LEVOTHYROXINE SODIUM **

UNIVASC, MOEXIPRIL HYDROCHLORIDE

UPTRAVI, SELEXIPAG

URECHOLINE, BETHANECHOL CHLORIDE

UREX, METHENAMINE HIPPURATE

UROCIT-K, POTASSIUM CITRATE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE

URSO 250, URSODIOL

URSO FORTE, URSODIOL

URSODIOL, URSODIOL

UTIBRON, GLYCOPYRROLATE

UVADEX, METHOXSALEN

VAGIFEM, ESTRADIOL

VAGISTAT-1, TIOCONAZOLE
(OTC)

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VALIUM, DIAZEPAM

VALNAC, BETAMETHASONE VALERATE

VALPROATE SODIUM, VALPROATE SODIUM

VALPROIC ACID, VALPROIC ACID

VALSARTAN, VALSARTAN

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSTAR PRESERVATIVE FREE, VALRUBICIN

VALTREX, VALACYCLOVIR HYDROCHLORIDE

VALTROPIN, SOMATROPIN RECOMBINANT

VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

VANDAZOLE, METRONIDAZOLE

VANIQA, EFLORNITHINE HYDROCHLORIDE

VANOS, FLUOCINONIDE

VANTAS, HISTRELIN ACETATE

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

VARITHENA, POLIDOCANOL

VARUBI, ROLAPITANT HYDROCHLORIDE

VASCEPA, ICOSAPENT ETHYL

VASERETIC, ENALAPRIL MALEATE

VASOSTRICT, VASOPRESSIN

VASOTEC, ENALAPRIL MALEATE

VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE

VECTICAL, CALCITRIOL

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VELCADE, BORTEZOMIB

VELETRI, EPOPROSTENOL SODIUM

VELIVET, DESOGESTREL

VELPHORO, SUCROFERRIC OXYHYDROXIDE

VELTASSA, PATIROMER SORBITEX CALCIUM

VELTIN, CLINDAMYCIN PHOSPHATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VENOFER, IRON SUCROSE

VENTAVIS, ILOPROST

VENTOLIN HFA, ALBUTEROL SULFATE

VERAMYST, FLUTICASONE FUROATE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VERDESO, DESONIDE

VEREGEN, SINECATECHINS

A - 57

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

VERELAN, VERAPAMIL HYDROCHLORIDE

VERELAN PM, VERAPAMIL HYDROCHLORIDE

VERSACLOZ, CLOZAPINE

VESICARE, SOLIFENACIN SUCCINATE

VEXOL, RIMEXOLONE

VFEND, VORICONAZOLE

VIAGRA, SILDENAFIL CITRATE

VIBATIV, TELAVANCIN HYDROCHLORIDE

VIBERZI, ELUXADOLINE

VIBISONE, CYANOCOBALAMIN

VIBRAMYCIN, DOXYCYCLINE

VIBRAMYCIN, DOXYCYCLINE CALCIUM

VIBRAMYCIN, DOXYCYCLINE HYCLATE

VICOPROFEN, HYDROCODONE BITARTRATE

VICTOZA, LIRAGLUTIDE RECOMBINANT

VICTRELIS, BOCEPREVIR

VIDAZA, AZACITIDINE

VIDEX, DIDANOSINE

VIDEX EC, DIDANOSINE

VIEKIRA PAK (COPACKAGED), DASABUVIR SODIUM

VIENVA, ETHINYL ESTRADIOL

VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE

VIIBRYD, VILAZODONE HYDROCHLORIDE

VIMOVO, ESOMEPRAZOLE MAGNESIUM

VIMPAT, LACOSAMIDE

VINBLASTINE SULFATE, VINBLASTINE SULFATE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

VIOKACE, PANCRELIPASE (AMYLASE

VIORELE, DESOGESTREL

VIRACEPT, NELFINAVIR MESYLATE

VIRAMUNE, NEVIRAPINE

VIRAMUNE XR, NEVIRAPINE

VIRAZOLE, RIBAVIRIN

VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VIROPTIC, TRIFLURIDINE

VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE

(OTC)

VISINE-A, NAPHAZOLINE HYDROCHLORIDE

(OTC)

VISIONBLUE, TRYPAN BLUE

VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL

VISTARIL, HYDROXYZINE PAMOATE

VISTOGARD, URIDINE TRIACETATE

VISUDYNE, VERTEPORFIN

VITAMIN D, ERGOCALCIFEROL

VITAMIN K1, PHYTONADIONE

VITEKTA, ELVITEGRAVIR

VITRASE, HYALURONIDASE

VITUZ, CHLORPHENIRAMINE MALEATE

VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE

VIVELLE, ESTRADIOL

VIVELLE-DOT, ESTRADIOL

VIVITROL, NALTREXONE

VIVLODEX, MELOXICAM

VIZAMYL, FLUTEMETAMOL F-18

VOGELXO, TESTOSTERONE

VOLTAREN, DICLOFENAC SODIUM

VOLTAREN-XR, DICLOFENAC SODIUM

VORICONAZOLE, VORICONAZOLE

VOSOL, ACETIC ACID, GLACIAL

VOSOL HC, ACETIC ACID, GLACIAL

VOSPIRE ER, ALBUTEROL SULFATE

VOTRIENT, PAZOPANIB HYDROCHLORIDE

VPRIV, VELAGLUCERASE ALFA

VRAYLAR, CARIPRAZINE HYDROCHLORIDE

A - 58

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

**

**

**

VUMON, TENIPOSIDE

VUSION, MICONAZOLE NITRATE

VYFEMLA, ETHINYL ESTRADIOL

VYTORIN, EZETIMIBE

VYVANSE, LISDEXAMFETAMINE DIMESYLATE

WARFARIN SODIUM, WARFARIN SODIUM

WELCHOL, COLESEVELAM HYDROCHLORIDE

WELLBUTRIN, BUPROPION HYDROCHLORIDE

WELLBUTRIN SR, BUPROPION HYDROCHLORIDE

WELLBUTRIN XL, BUPROPION HYDROCHLORIDE

WERA, ETHINYL ESTRADIOL

WOMEN'S ROGAINE, MINOXIDIL

(OTC)

XALATAN, LATANOPROST

XALKORI, CRIZOTINIB

XANAX, ALPRAZOLAM

XANAX XR, ALPRAZOLAM

XARELTO, RIVAROXABAN

XARTEMIS XR, ACETAMINOPHEN

XELJANZ, TOFACITINIB CITRATE

XELODA, CAPECITABINE

XENAZINE, TETRABENAZINE

XENICAL, ORLISTAT

XENON XE 133, XENON XE-133

XERESE, ACYCLOVIR

XIFAXAN, RIFAXIMIN

XIGDUO XR, DAPAGLIFLOZIN PROPANEDIOL

XOFIGO, RADIUM RA-223 DICHLORIDE

XOLEGEL, KETOCONAZOLE

XOPENEX, LEVALBUTEROL HYDROCHLORIDE

XOPENEX HFA, LEVALBUTEROL TARTRATE

XTANDI, ENZALUTAMIDE

XTORO, FINAFLOXACIN

XULANE, ETHINYL ESTRADIOL

XURIDEN, URIDINE TRIACETATE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE

XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYREM, SODIUM OXYBATE

XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

**

**

**

**

YAELA, DROSPIRENONE

YASMIN, DROSPIRENONE

YAZ, DROSPIRENONE

YONDELIS, TRABECTEDIN

ZADITOR, KETOTIFEN FUMARATE

(OTC)

ZAFIRLUKAST, ZAFIRLUKAST

ZALEPLON, ZALEPLON

ZANAFLEX, TIZANIDINE HYDROCHLORIDE

ZANOSAR, STREPTOZOCIN

ZANTAC, RANITIDINE HYDROCHLORIDE

ZANTAC 150, RANITIDINE HYDROCHLORIDE

(OTC)

ZANTAC 150, RANITIDINE HYDROCHLORIDE

ZANTAC 300, RANITIDINE HYDROCHLORIDE

ZANTAC 75, RANITIDINE HYDROCHLORIDE

(OTC)

ZARONTIN, ETHOSUXIMIDE

ZAROXOLYN, METOLAZONE

A - 59

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ZAVESCA, MIGLUSTAT

ZEBETA, BISOPROLOL FUMARATE

ZECUITY, SUMATRIPTAN SUCCINATE

ZEGERID, OMEPRAZOLE

ZEGERID OTC, OMEPRAZOLE

(OTC)

ZELAPAR, SELEGILINE HYDROCHLORIDE

ZELBORAF, VEMURAFENIB

ZEMPLAR, PARICALCITOL

ZENATANE, ISOTRETINOIN

ZENPEP, PANCRELIPASE (AMYLASE

ZERBAXA, CEFTOLOZANE SULFATE

ZERIT, STAVUDINE

ZESTORETIC, HYDROCHLOROTHIAZIDE

ZESTRIL, LISINOPRIL

ZETIA, EZETIMIBE

ZETONNA, CICLESONIDE

ZIAC, BISOPROLOL FUMARATE

ZIAGEN, ABACAVIR SULFATE

ZIANA, CLINDAMYCIN PHOSPHATE

ZIDOVUDINE, ZIDOVUDINE

ZINACEF, CEFUROXIME SODIUM

ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE

ZINECARD, DEXRAZOXANE HYDROCHLORIDE

ZINGO, LIDOCAINE HYDROCHLORIDE

ZIOPTAN, TAFLUPROST

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZIPSOR, DICLOFENAC POTASSIUM

ZIRGAN, GANCICLOVIR

ZITHROMAX, AZITHROMYCIN

ZMAX, AZITHROMYCIN

ZOCOR, SIMVASTATIN

ZOFRAN, ONDANSETRON HYDROCHLORIDE

ZOFRAN ODT, ONDANSETRON

ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ZOHYDRO ER, HYDROCODONE BITARTRATE

ZOLADEX, GOSERELIN ACETATE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ZOLINZA, VORINOSTAT

ZOLMITRIPTAN, ZOLMITRIPTAN

ZOLOFT, SERTRALINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZOLPIMIST, ZOLPIDEM TARTRATE

ZOMACTON, SOMATROPIN RECOMBINANT

ZOMETA, ZOLEDRONIC ACID

ZOMIG, ZOLMITRIPTAN

ZOMIG-ZMT, ZOLMITRIPTAN

ZONALON, DOXEPIN HYDROCHLORIDE

ZONEGRAN, ZONISAMIDE

ZONISAMIDE, ZONISAMIDE

ZONTIVITY, VORAPAXAR SULFATE

ZORBTIVE, SOMATROPIN RECOMBINANT

ZORTRESS, EVEROLIMUS

ZORVOLEX, DICLOFENAC

ZOSYN, PIPERACILLIN SODIUM

ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

ZOVIA 1/35E-28, ETHINYL ESTRADIOL

ZOVIA 1/50E-28, ETHINYL ESTRADIOL

ZOVIRAX, ACYCLOVIR

ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE

ZUPLENZ, ONDANSETRON

ZURAMPIC, LESINURAD

ZUTRIPRO, CHLORPHENIRAMINE MALEATE

ZYBAN, BUPROPION HYDROCHLORIDE

ZYCLARA, IMIQUIMOD

A - 60

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ZYDELIG, IDELALISIB

ZYFLO, ZILEUTON

ZYFLO CR, ZILEUTON

ZYKADIA, CERITINIB

ZYLET, LOTEPREDNOL ETABONATE

ZYLOPRIM, ALLOPURINOL

ZYMAR, GATIFLOXACIN

ZYMAXID, GATIFLOXACIN

ZYPREXA, OLANZAPINE

ZYPREXA RELPREVV, OLANZAPINE PAMOATE

ZYPREXA ZYDIS, OLANZAPINE

ZYRTEC, CETIRIZINE HYDROCHLORIDE

ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE

(OTC)

ZYTIGA, ABIRATERONE ACETATE

ZYVOX, LINEZOLID

A - 61

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

3D IMAGING DRUG

* 3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

3M

* 3M CO

PERIDEX, CHLORHEXIDINE GLUCONATE

* 3M HEALTH CARE INC

AVAGARD, ALCOHOL
(OTC)

DURAPREP, IODINE POVACRYLEX

(OTC)

* 3M PHARMACEUTICALS INC

PROVENTIL-HFA, ALBUTEROL SULFATE

**

**

AAIPHARMA LLC

* AAIPHARMA LLC

AZASAN, AZATHIOPRINE

ABBVIE

* ABBVIE INC

ADVICOR, LOVASTATIN

ANDROGEL, TESTOSTERONE

BIAXIN, CLARITHROMYCIN

CREON, PANCRELIPASE (AMYLASE

CYCLOSPORINE, CYCLOSPORINE

DEPACON, VALPROATE SODIUM

DEPAKENE, VALPROIC ACID

DEPAKOTE ER, DIVALPROEX SODIUM

DEPAKOTE, DIVALPROEX SODIUM

GENGRAF, CYCLOSPORINE

K-TAB, POTASSIUM CHLORIDE

KALETRA, LOPINAVIR

MARINOL, DRONABINOL

MAVIK, TRANDOLAPRIL

MIVACRON, MIVACURIUM CHLORIDE

NIASPAN, NIACIN

NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE

NIMBEX, CISATRACURIUM BESYLATE

NORVIR, RITONAVIR

ORETIC, HYDROCHLOROTHIAZIDE

SIMCOR, NIACIN

SURVANTA, BERACTANT

SYNTHROID, LEVOTHYROXINE SODIUM **

TARKA, TRANDOLAPRIL

TEVETEN, EPROSARTAN MESYLATE

TRICOR, FENOFIBRATE

TRIDIONE, TRIMETHADIONE

TRILIPIX, CHOLINE FENOFIBRATE

ULTANE, SEVOFLURANE

VICOPROFEN, HYDROCODONE BITARTRATE

ZEMPLAR, PARICALCITOL

ABBVIE ENDOCRINE

* ABBVIE ENDOCRINE INC

LUPANETA PACK, LEUPROLIDE ACETATE

ABBVIE ENDOCRINE INC

* ABBVIE ENDOCRINE INC

LUPRON DEPOT, LEUPROLIDE ACETATE

LUPRON DEPOT-PED, LEUPROLIDE ACETATE

ABBVIE INC

* ABBVIE INC

DUOPA, CARBIDOPA

PROMETRIUM, PROGESTERONE

TECHNIVIE, OMBITASVIR

VIEKIRA PAK (COPACKAGED), DASABUVIR SODIUM

ABHAI

B - 1

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ABHAI LLC

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

ABHAI INC

* ABHAI INC

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

ABRAXIS BIOSCIENCE

* ABRAXIS BIOSCIENCE LLC

ABRAXANE, PACLITAXEL

ABRAXIS PHARM

* ABRAXIS PHARMACEUTICAL PRODUCTS

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE

ACCELRX LABS

* ACCELRX LABS LLC

CARISOPRODOL, CARISOPRODOL

ACCORD HLTHCARE

* ACCORD HEALTHCARE INC

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

BICALUTAMIDE, BICALUTAMIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CAPECITABINE, CAPECITABINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CISPLATIN, CISPLATIN

CLONAZEPAM, CLONAZEPAM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOZAPINE, CLOZAPINE

DOCETAXEL, DOCETAXEL

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ETOPOSIDE, ETOPOSIDE

FINASTERIDE, FINASTERIDE

FLUOROURACIL, FLUOROURACIL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE, GLIPIZIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL, LISINOPRIL

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHYLDOPA, METHYLDOPA

MITOMYCIN, MITOMYCIN

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

TACROLIMUS, TACROLIMUS

TOPIRAMATE, TOPIRAMATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

ACCORD HLTHCARE INC

* ACCORD HEALTHCARE INC USA

FINASTERIDE, FINASTERIDE

RAMIPRIL, RAMIPRIL

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

ACELLA PHARMS LLC

* ACELLA PHARMACEUTICALS LLC

GABAPENTIN, GABAPENTIN

B - 2

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 3

PRODUCT NAME SORTED BY APPLICANT

**

**

ACI HEALTHCARE LTD

* ACI HEALTHCARE LTD

GABAPENTIN, GABAPENTIN

ACIC FINE CHEMS

* ACIC FINE CHEMICALS INC

TRANEXAMIC ACID, TRANEXAMIC ACID

ACORDA

* ACORDA THERAPEUTICS INC

AMPYRA, DALFAMPRIDINE

QUTENZA, CAPSAICIN

ZANAFLEX, TIZANIDINE HYDROCHLORIDE

ACS DOBFAR

* ACS DOBFAR SPA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFOXITIN, CEFOXITIN SODIUM

CEFTAZIDIME, CEFTAZIDIME

CEFTRIAXONE, CEFTRIAXONE SODIUM

IMIPENEM AND CILASTATIN, CILASTATIN SODIUM

KEFZOL, CEFAZOLIN SODIUM

MEROPENEM, MEROPENEM

ACS DOBFAR INFO SA

* ACS DOBFAR INFO SA

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ACS DOBFAR SPA

* ACS DOBFAR SPA

AMPICILLIN SODIUM, AMPICILLIN SODIUM

ACTAVIS ELIZABETH

* ACTAVIS ELIZABETH LLC

ALPRAZOLAM, ALPRAZOLAM

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GABAPENTIN, GABAPENTIN

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

INDAPAMIDE, INDAPAMIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LOVASTATIN, LOVASTATIN

MORPHINE SULFATE, MORPHINE SULFATE

NIFEDIPINE, NIFEDIPINE

OXAZEPAM, OXAZEPAM

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 4

PRODUCT NAME SORTED BY APPLICANT

**

**

* ACTAVIS ELIZABETH LLC

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROPYLTHIOURACIL, PROPYLTHIOURACIL
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SPIRONOLACTONE, SPIRONOLACTONE
TEMAZEPAM, TEMAZEPAM
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ACTAVIS GRP PTC
* ACTAVIS GROUP PTC EHF
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
ACTAVIS INC
* ACTAVIS INC
DOCETAXEL, DOCETAXEL
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
METHOXSALEN, METHOXSALEN
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ACTAVIS LABS FL INC
* ACTAVIS LABORATORIES FL INC
ALPRAZOLAM, ALPRAZOLAM
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CABERGOLINE, CABERGOLINE
CARTIA XT, DILTIAZEM HYDROCHLORIDE
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CLARITHROMYCIN, CLARITHROMYCIN
CLOZAPINE, CLOZAPINE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE
DUTASTERIDE, DUTASTERIDE
FLUTAMIDE, FLUTAMIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GLIMEPIRIDE, GLIMEPIRIDE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN
(OTC)
GUAIFENESIN, GUAIFENESIN
(OTC)
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
KETOPROFEN, KETOPROFEN
LEVETIRACETAM, LEVETIRACETAM
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE
(OTC)
LORATADINE, LORATADINE
(OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MIRTAZAPINE, MIRTAZAPINE
NAPROXEN SODIUM, NAPROXEN SODIUM
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
NORCO, ACETAMINOPHEN
OMEPRAZOLE, OMEPRAZOLE
OXYCODONE AND ASPIRIN, ASPIRIN
PALIPERIDONE, PALIPERIDONE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMELTEON, RAMELTEON

(OTC)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ACTAVIS LABORATORIES FL INC

RISPERIDONE, RISPERIDONE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAZTIA XT, DILTIAZEM HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ACTAVIS LABS NY INC
* ACTAVIS LABORATORIES NY INC
NICOTINE POLACRILEX, NICOTINE POLACRILEX
(OTC)
ACTAVIS LABS UT INC
* ACTAVIS LABORATORIES UT INC
ACTIGALL, URSODIOL
ALORA, ESTRADIOL
ANDRODERM, TESTOSTERONE
BREVICON 28-DAY, ETHINYL ESTRADIOL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLONIDINE, CLONIDINE
CONDYLOX, PODOFILOX
CORDRAN, FLURANDRENOLIDE
CRINONE, PROGESTERONE
EMLA, LIDOCAINE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
FIORICET W/ CODEINE, ACETAMINOPHEN
FIORINAL W/CODEINE, ASPIRIN
FIORINAL, ASPIRIN
GELNIQUE 3%, OXYBUTYNIN
GELNIQUE, OXYBUTYNIN CHLORIDE
INFED, IRON DEXTRAN
KADIAN, MORPHINE SULFATE
LIDOCAINE, LIDOCAINE
MICROZIDE, HYDROCHLOROTHIAZIDE
NOR-QD, NORETHINDRONE
NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL
NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL
NORINYL 1+50 28-DAY, MESTRANOL
NUVESSA, METRONIDAZOLE
OXYTROL, OXYBUTYNIN
PROGESTERONE, PROGESTERONE
RAPAFLO, SILODOSIN
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE
TENUATE, DIETHYLPROPION HYDROCHLORIDE
TESTOSTERONE, TESTOSTERONE
TRELSTAR, TRIPTORELIN PAMOATE
TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL
ACTAVIS MID ATLANTIC
* ACTAVIS MID ATLANTIC LLC
ACETASOL HC, ACETIC ACID, GLACIAL
ACYCLOVIR, ACYCLOVIR
ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE
ADAPALENE, ADAPALENE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE AND TRETINOIN, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
(OTC)
CONSTULOSE, LACTULOSE
DESOXIMETASONE, DESOXIMETASONE

B - 5

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ACTAVIS MID ATLANTIC LLC

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ENULOSE, LACTULOSE

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROCORTISONE, HYDROCORTISONE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN
(OTC)

LEVETIRACETAM, LEVETIRACETAM

M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MICONAZOLE 7, MICONAZOLE NITRATE

(OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE

MICONAZOLE NITRATE, MICONAZOLE NITRATE

(OTC)

MINOXIDIL (FOR MEN), MINOXIDIL

(OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL

(OTC)

NYSTATIN, NYSTATIN

PERMETHRIN, PERMETHRIN

PERMETHRIN, PERMETHRIN
(OTC)

PROMETH VC W/ CODEINE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

VALNAC, BETAMETHASONE VALERATE

ACTAVIS TOTOWA

* ACTAVIS TOTOWA LLC

BICALUTAMIDE, BICALUTAMIDE

CARBOPLATIN, CARBOPLATIN

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

REPAGLINIDE, REPAGLINIDE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ACTELION PHARMS LTD

* ACTELION PHARMACEUTICALS LTD

OPSUMIT, MACITENTAN

TRACLEER, BOSENTAN

UPTRAVI, SELEXIPAG

VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE

VELETRI, EPOPROSTENOL SODIUM

VENTAVIS, ILOPROST

ZAVESCA, MIGLUSTAT

ACTIENT PHARMS

* ACTIENT PHARMACEUTICALS LLC

TESTOPEL, TESTOSTERONE

THEO-24, THEOPHYLLINE

ACTIVIS TOTOWA LLC

* ACTIVIS TOTOWA LLC

TOPIRAMATE, TOPIRAMATE

ADAPT PHARMA

* ADAPT PHARMA INC

NARCAN, NALOXONE HYDROCHLORIDE

ADARE PHARMS INC

* ADARE PHARMACEUTICALS INC

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

AEGERION

* AEGERION PHARMACEUTICALS INC

JUXTAPID, LOMITAPIDE MESYLATE

B - 6

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 7

PRODUCT NAME SORTED BY APPLICANT

**

**

AGOURON

* AGOURON PHARMACEUTICALS INC

VIRACEPT, NELFINAVIR MESYLATE

AIPING PHARM INC

* AIPING PHARMACEUTICAL INC

FOLIC ACID, FOLIC ACID

AJANTA PHARMA

* AJANTA PHARMA LTD

LEVETIRACETAM, LEVETIRACETAM

AJANTA PHARMA LTD

* AJANTA PHARMA LTD

IRBESARTAN, IRBESARTAN

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

RISPERIDONE, RISPERIDONE

AKORN

* AKORN INC

ADENOSINE, ADENOSINE

AK-FLUOR 10%, FLUORESCEIN SODIUM

AK-FLUOR 25%, FLUORESCEIN SODIUM

AKBETA, LEVOBUNOLOL HYDROCHLORIDE

AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE

AKTEN, LIDOCAINE HYDROCHLORIDE

AKTOB, TOBRAMYCIN

ALFENTA, ALFENTANIL HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ATROPINE SULFATE, ATROPINE SULFATE

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BAL, DIMERCAPROL

BALANCED SALT, CALCIUM CHLORIDE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CALCITRIOL, CALCITRIOL

CAPASTAT SULFATE, CAPREOMYCIN SULFATE

CARBOPLATIN, CARBOPLATIN

CROMOLYN SODIUM, CROMOLYN SODIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ENDOSOL EXTRA, CALCIUM CHLORIDE

ERYTHROMYCIN, ERYTHROMYCIN

GENTAK, GENTAMICIN SULFATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IC-GREEN, INDOCYANINE GREEN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE

(OTC)

LATANOPROST, LATANOPROST

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

NEDOCROMIL SODIUM, NEDOCROMIL SODIUM

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

OFLOXACIN, OFLOXACIN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE

SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE

SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TROPICACYL, TROPICAMIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 8

PRODUCT NAME SORTED BY APPLICANT

**

**

* AKORN INC

ZOLEDRONIC ACID, ZOLEDRONIC ACID

AKORN INC

* AKORN INC

ACETYLCYSTEINE, ACETYLCYSTEINE

APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE

CEFTRIAXONE, CEFTRIAXONE SODIUM

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CYCLOPENTOLATE HYDROCHLORIDE, CYCLOPENTOLATE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DRONABINOL, DRONABINOL

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

INAPSINE, DROPERIDOL

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE

(OTC)

NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

TOBRAMYCIN, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ALARA PHARM

* ALARA PHARMACEUTICAL CORPORATION

LEVO-T, LEVOTHYROXINE SODIUM **

ALCON

* ALCON INC

TRIESENCE, TRIAMCINOLONE ACETONIDE

* ALCON LABORATORIES INC

ALCAINE, PROPARACAINE HYDROCHLORIDE

ALOMIDE, LODOXAMIDE TROMETHAMINE

BETOPTIC S, BETAXOLOL HYDROCHLORIDE

BETOPTIC, BETAXOLOL HYDROCHLORIDE

BSS PLUS, CALCIUM CHLORIDE

BSS, CALCIUM CHLORIDE

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

CROMOLYN SODIUM, CROMOLYN SODIUM

CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE

DENDRID, IDOXURIDINE

EMADINE, EMEDASTINE DIFUMARATE

FLAREX, FLUOROMETHOLONE ACETATE

IOPIDINE, APRACLONIDINE HYDROCHLORIDE

MAXIDEX, DEXAMETHASONE

MAXITROL, DEXAMETHASONE

MIOSTAT, CARBACHOL

MYDRIACYL, TROPICAMIDE

NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE

(OTC)

NATACYN, NATAMYCIN

OMNIPRED, PREDNISOLONE ACETATE

PATANOL, OLOPATADINE HYDROCHLORIDE

TOBRADEX, DEXAMETHASONE

TOBREX, TOBRAMYCIN

VEXOL, RIMEXOLONE

ALCON LABS INC

* ALCON LABORATORIES INC

CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE

MAXITROL, DEXAMETHASONE

TOBREX, TOBRAMYCIN

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 9

PRODUCT NAME SORTED BY APPLICANT

**

**

ALCON PHARMA
* ALCON RESEARCH LTD
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
ZADITOR, KETOTIFEN FUMARATE
(OTC)

ALCON PHARMS LTD

* ALCON PHARMACEUTICALS LTD

AZOPT, BRINZOLAMIDE

BETADINE, POVIDONE-IODINE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CILOXAN, CIPROFLOXACIN HYDROCHLORIDE

CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE

CIPRODEX, CIPROFLOXACIN

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DUREZOL, DIFLUPREDNATE

FLUORESCITE, FLUORESCEIN SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE

(OTC)

MOXEZA, MOXIFLOXACIN HYDROCHLORIDE

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEVANAC, NEPAFENAC

OFLOXACIN, OFLOXACIN

PATADAY, OLOPATADINE HYDROCHLORIDE

PATANASE, OLOPATADINE HYDROCHLORIDE

QOLIANA, BRIMONIDINE TARTRATE

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TOBRADEX ST, DEXAMETHASONE

TRAVATAN Z, TRAVOPROST

TRIFLURIDINE, TRIFLURIDINE

VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE

ALCON RES

* ALCON RESEARCH LTD

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE

LATANOPROST, LATANOPROST

ALCON RES LTD

* ALCON RESEARCH LTD

BIMATOPROST, BIMATOPROST

GENTAMICIN SULFATE, GENTAMICIN SULFATE

ILEVRO, NEPAFENAC

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

PAZEO, OLOPATADINE HYDROCHLORIDE

SIMBRINZA, BRIMONIDINE TARTRATE

TIMOLOL MALEATE, TIMOLOL MALEATE

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

XTORO, FINAFLOXACIN

ALEMBIC LTD

* ALEMBIC LTD

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

METRONIDAZOLE, METRONIDAZOLE

MODAFINIL, MODAFINIL

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ALEMBIC PHARMS LTD

* ALEMBIC PHARMACEUTICALS LTD

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

CELECOXIB, CELECOXIB

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ALEMBIC PHARMACEUTICALS LTD

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DESVENLAFAXINE, DESVENLAFAXINE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FAMOTIDINE, FAMOTIDINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LAMOTRIGINE, LAMOTRIGINE

LEFLUNOMIDE, LEFLUNOMIDE

LINEZOLID, LINEZOLID

LITHIUM CARBONATE, LITHIUM CARBONATE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MEPROBAMATE, MEPROBAMATE

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

VALSARTAN, VALSARTAN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

ALIMERA SCIENCES INC

* ALIMERA SCIENCES INC

ILUVIEN, FLUOCINOLONE ACETONIDE

ALKEM

* ALKEM LABORATORIES LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

GABAPENTIN, GABAPENTIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ALKEM LABS LTD

* ALKEM LABORATORIES LTD

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

GABAPENTIN, GABAPENTIN

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LINEZOLID, LINEZOLID

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

OLANZAPINE, OLANZAPINE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

ALKERMES

* ALKERMES INC

VIVITROL, NALTREXONE

ALKERMES INC

* ALKERMES INC

ARISTADA, ARIPIPRAZOLE LAUROXIL

ALKOPHARMA USA

* ALKOPHARMA USA INC

AMPHOTEC, AMPHOTERICIN B

ALLEGIANCE HLTHCARE

* ALLEGIANCE HEALTHCARE CORP

POVIDONE IODINE, POVIDONE-IODINE

(OTC)

ALLERGAN

* ALLERGAN

ACULAR LS, KETOROLAC TROMETHAMINE

ALPHAGAN P, BRIMONIDINE TARTRATE

BLEPH-10, SULFACETAMIDE SODIUM

B - 10

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 11

PRODUCT NAME SORTED BY APPLICANT

**

**

* ALLERGAN

GENOPTIC, GENTAMICIN SULFATE

ZYMAXID, GATIFLOXACIN

* ALLERGAN INC

ACULAR, KETOROLAC TROMETHAMINE

ACUVAIL, KETOROLAC TROMETHAMINE

ACZONE, DAPSONE

ALOCRIL, NEDOCROMIL SODIUM

ALPHAGAN P, BRIMONIDINE TARTRATE

AVAGE, TAZAROTENE

AZELEX, AZELAIC ACID

COMBIGAN, BRIMONIDINE TARTRATE

ELESTAT, EPINASTINE HYDROCHLORIDE

LASTACAFT, ALCAFTADINE

LATISSE, BIMATOPROST

LUMIGAN, BIMATOPROST

OCUFLOX, OFLOXACIN

OZURDEX, DEXAMETHASONE

POLYTRIM, POLYMYXIN B SULFATE

RESTASIS, CYCLOSPORINE

TAZORAC, TAZAROTENE

ZYMAR, GATIFLOXACIN

* ALLERGAN PHARMACEUTICAL

BETAGAN, LEVOBUNOLOL HYDROCHLORIDE

BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE

BLEPHAMIDE, PREDNISOLONE ACETATE

FML FORTE, FLUOROMETHOLONE

FML, FLUOROMETHOLONE

HERPLEX, IDOXURIDINE

OCUFEN, FLURBIPROFEN SODIUM

PRED FORTE, PREDNISOLONE ACETATE

PRED MILD, PREDNISOLONE ACETATE

PRED-G, GENTAMICIN SULFATE

ALLERQUEST

* ALLERQUEST LLC

PRE-PEN, BENZYLPENICILLOYL POLYLYSINE

ALLIED PHARMA INC

* ALLIED PHARMA INC

CLARITHROMYCIN, CLARITHROMYCIN

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

ALLOS

* ALLOS THERAPEUTICS INC

FOLOTYN, PRALATREXATE

ALPHARMA

* ALPHARMA USPD INC

PREDNISOLONE, PREDNISOLONE

VALPROIC ACID, VALPROIC ACID

ALPHARMA PHARMS

* ALPHARMA PHARMACEUTICALS LLC

EMBEDA, MORPHINE SULFATE

ALRA

* ALRA LABORATORIES INC

CHOLAC, LACTULOSE

CONSTILAC, LACTULOSE

GEN-XENE, CLORAZEPATE DIPOTASSIUM

IBU-TAB 200, IBUPROFEN

(OTC)

IBU-TAB, IBUPROFEN

ALTAIRE PHARMS INC

* ALTAIRE PHARMACEUTICALS INC

DICLOFENAC SODIUM, DICLOFENAC SODIUM

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE

OFLOXACIN, OFLOXACIN

ALTATHERA PHARMS LLC

* ALTATHERA PHARMACEUTICALS LLC

(OTC)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ALTATHERA PHARMACEUTICALS LLC

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

ALVOGEN

* ALVOGEN INC

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

ALVOGEN INC

* ALVOGEN INC

ACETYLCYSTEINE, ACETYLCYSTEINE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

EXEMESTANE, EXEMESTANE

MACROBID, NITROFURANTOIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

ALVOGEN IPCO SARL

* ALVOGEN IPCO SARL

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

TENORETIC 100, ATENOLOL

TENORETIC 50, ATENOLOL

TENORMIN, ATENOLOL

ZESTORETIC, HYDROCHLOROTHIAZIDE

ZESTRIL, LISINOPRIL

ALVOGEN MALTA

* ALVOGEN MALTA OPERATIONS LTD

CARBIDOPA, CARBIDOPA

MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE

NAPRELAN, NAPROXEN SODIUM

NATEGLINIDE, NATEGLINIDE

NEVIRAPINE, NEVIRAPINE

ALVOGEN PINE BROOK

* ALVOGEN PINE BROOK INC

DISULFIRAM , DISULFIRAM

RIVASTIGMINE, RIVASTIGMINE

AM ANTIBIOTICS

* AMERICAN ANTIBIOTICS INC

AMOXICILLIN, AMOXICILLIN

AMAG PHARMS INC

* AMAG PHARMACEUTICALS INC

FERAHEME, FERUMOXYTOL

AMARIN PHARMS

* AMARIN PHARMACEUTICALS IRELAND LTD

VASCEPA, ICOSAPENT ETHYL

AMEDRA PHARMS

* AMEDRA PHARMACEUTICALS LLC

ADRENACLICK, EPINEPHRINE

DEXEDRINE, DEXTROAMPHETAMINE SULFATE

HYDROCORTISONE, HYDROCORTISONE

TWINJECT 0.15, EPINEPHRINE

TWINJECT 0.3, EPINEPHRINE

AMEDRA PHARMS LLC

* AMEDRA PHARMACEUTICALS LLC

ALBENZA, ALBENDAZOLE

MEBENDAZOLE, MEBENDAZOLE

AMERIGEN PHARMS LTD

* AMERIGEN PHARMACEUTICALS LTD

CARBIDOPA, CARBIDOPA

AMGEN

* AMGEN INC

SENSIPAR, CINACALCET HYDROCHLORIDE

AMGEN INC

* AMGEN INC

B - 12

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 13

PRODUCT NAME SORTED BY APPLICANT

**

**

* AMGEN INC

CORLANOR, IVABRADINE HYDROCHLORIDE

AMHERST PHARMS LLC

* AMHERST PHARMACEUTICALS LLC

ZOLPIMIST, ZOLPIDEM TARTRATE

AMNEAL PHARM

* AMNEAL PHARMACEUTICAL

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FOLIC ACID, FOLIC ACID

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

AMNEAL PHARMS

* AMNEAL PHARMACEUTICALS

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATOVAQUONE, ATOVAQUONE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE , BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CALCIUM ACETATE, CALCIUM ACETATE

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DUTASTERIDE, DUTASTERIDE

ENTECAVIR, ENTECAVIR

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FELBAMATE, FELBAMATE

GABAPENTIN, GABAPENTIN

IBUPROFEN, IBUPROFEN
(OTC)

INDOMETHACIN, INDOMETHACIN

ITRACONAZOLE, ITRACONAZOLE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE, LIDOCAINE

LINEZOLID, LINEZOLID

LORAZEPAM, LORAZEPAM

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METAXALONE, METAXALONE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NIACIN, NIACIN

NITROFURANTOIN, NITROFURANTOIN

NIZATIDINE, NIZATIDINE

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PARICALCITOL, PARICALCITOL

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

QUININE SULFATE, QUININE SULFATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 14

PRODUCT NAME SORTED BY APPLICANT

**

**

* AMNEAL PHARMACEUTICALS

RISPERIDONE, RISPERIDONE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SPIRONOLACTONE, SPIRONOLACTONE

TELMISARTAN, TELMISARTAN

TEMOZOLOMIDE, TEMOZOLOMIDE

TOBRAMYCIN, TOBRAMYCIN

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

VALSARTAN, VALSARTAN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

* AMNEAL PHARMACEUTICALS LLC

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

* AMNEAL PHARMACEUTICALS OF NEW YORK LLC

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

AMNEAL PHARMS CO

* AMNEAL PHARMACEUTICALS CO GMBH

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

AMNEAL PHARMS LLC

* AMNEAL PHARMACEUTICALS LLC

ACTIVELLA, ESTRADIOL

AZATHIOPRINE, AZATHIOPRINE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

AMNEAL PHARMS NY

* AMNEAL PHARMACEUTICALS NY LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ALPRAZOLAM, ALPRAZOLAM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

GABAPENTIN, GABAPENTIN

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN
(OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

NAPROXEN, NAPROXEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

REPREXAIN, HYDROCODONE BITARTRATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

AMPHASTAR PHARM

* AMPHASTAR PHARMACEUTICAL INC

AMPHADASE, HYALURONIDASE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

AMPHASTAR PHARMS INC

* AMPHASTAR PHARMACEUTICALS INC

CORTROSYN, COSYNTROPIN

AMPOLGEN

* AMPOLGEN PHARMACEUTICALS LLC

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

ANACOR PHARMS INC

* ANACOR PHARMACEUTICALS INC

KERYDIN, TAVABOROLE

ANBEX

* ANBEX INC

IOSAT, POTASSIUM IODIDE

(OTC)

ANBISON LAB CO LTD

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ANBISON LABORATORY CO LTD

MONTELUKAST SODIUM, MONTELUKAST SODIUM

ANCHEN PHARMS

* ANCHEN PHARMACEUTICALS INC

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE , CLONIDINE HYDROCHLORIDE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRETINOIN, TRETINOIN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* ANCHEN PHARMACEUTICALS TAIWAN INC

DIVALPROEX SODIUM, DIVALPROEX SODIUM

* ANCHEN PHARMACEUTICALS, INC

ALPRAZOLAM, ALPRAZOLAM

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ANDRX LABS LLC

* ANDRX LABS LLC

FORTAMET, METFORMIN HYDROCHLORIDE

ANI PHARMS

* ANI PHARMACEUTICALS INC

CORTENEMA, HYDROCORTISONE

LACTULOSE, LACTULOSE

LUVOX, FLUVOXAMINE MALEATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE

ANI PHARMS INC

* ANI PHARMACEUTICALS INC

ALPRAZOLAM, ALPRAZOLAM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CHLORPROPAMIDE, CHLORPROPAMIDE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

ETODOLAC, ETODOLAC

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GLIPIZIDE, GLIPIZIDE

GUANABENZ ACETATE, GUANABENZ ACETATE

INDAPAMIDE, INDAPAMIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LITHOBID, LITHIUM CARBONATE

LORAZEPAM, LORAZEPAM

METHAZOLAMIDE, METHAZOLAMIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NIZATIDINE, NIZATIDINE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

(OTC)

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RISPERIDONE, RISPERIDONE

TESTOSTERONE, TESTOSTERONE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALPROIC ACID, VALPROIC ACID

VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ANTARES PHARMA INC

B - 15

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ANTARES PHARMA INC

OTREXUP, METHOTREXATE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

ANTIBIOTICE

* ANTIBIOTICE SA

AMPICILLIN SODIUM, AMPICILLIN SODIUM

NAFCILLIN SODIUM, NAFCILLIN SODIUM

ANTIBIOTICOS BRASIL

* ANTIBIOTICOS DO BRASIL LTDA

CEFOXITIN, CEFOXITIN SODIUM

ANTIBIOTICS SA

* ANTIBIOTICS SA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

ANTRIM PHARMS LLC

* ANTRIM PHARMACEUTICALS LLC

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

APGDI

* ASTELLAS PHARMA GLOBAL DEVELOPMENT INC

MYRBETRIQ, MIRABEGRON

APOPHARMA INC

* APOPHARMA INC

FERRIPROX, DEFERIPRONE

APOTEX

* APOTEX CORP

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

* APOTEX INC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CAPTOPRIL, CAPTOPRIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CIMETIDINE, CIMETIDINE

CIMETIDINE, CIMETIDINE
(OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CYCLOSPORINE, CYCLOSPORINE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

EPLERENONE, EPLERENONE

ETODOLAC, ETODOLAC

FAMCICLOVIR, FAMCICLOVIR

FAMOTIDINE, FAMOTIDINE

FLUCONAZOLE, FLUCONAZOLE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GEMFIBROZIL, GEMFIBROZIL

GLIPIZIDE, GLIPIZIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LAMIVUDINE, LAMIVUDINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENTOXIFYLLINE, PENTOXIFYLLINE

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

B - 16

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* APOTEX INC

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

APOTEX CORP

* APOTEX CORP

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

CABERGOLINE, CABERGOLINE

CLARITHROMYCIN, CLARITHROMYCIN

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RILUZOLE, RILUZOLE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

APOTEX INC

* APOTEX INC

ABACAVIR SULFATE, ABACAVIR SULFATE

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BENZONATATE, BENZONATATE

BICALUTAMIDE, BICALUTAMIDE

BIMATOPROST, BIMATOPROST

BROMFENAC SODIUM, BROMFENAC SODIUM

CALCITONIN-SALMON, CALCITONIN SALMON

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CARBAMAZEPINE, CARBAMAZEPINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CEFPROZIL, CEFPROZIL

CELECOXIB, CELECOXIB

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CEVIMELINE, CEVIMELINE HYDROCHLORIDE

CICLOPIROX, CICLOPIROX

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IMIQUIMOD, IMIQUIMOD

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LAMIVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

B - 17

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* APOTEX INC
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
LOVASTATIN, LOVASTATIN
MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE
MODAFINIL, MODAFINIL
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
NABUMETONE, NABUMETONE
NEVIRAPINE, NEVIRAPINE
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
OXCARBAZEPINE, OXCARBAZEPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
RASAGILINE MESYLATE, RASAGILINE MESYLATE
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RISPERIDONE, RISPERIDONE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIMOLOL MALEATE, TIMOLOL MALEATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRANEXAMIC ACID, TRANEXAMIC ACID
TRAVOPROST, TRAVOPROST
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ZOLMITRIPTAN, ZOLMITRIPTAN
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* APOTEX INC ETOBICOKE SITE
ACYCLOVIR, ACYCLOVIR
ALLOPURINOL, ALLOPURINOL
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBAMAZEPINE, CARBAMAZEPINE
CARVEDILOL, CARVEDILOL
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DILTZAC, DILTIAZEM HYDROCHLORIDE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
LEFLUNOMIDE, LEFLUNOMIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LORATADINE, LORATADINE
(OTC)
MELOXICAM, MELOXICAM
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
OXAPROZIN, OXAPROZIN
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

B - 18

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* APOTEX INC ETOBICOKE SITE

TOPIRAMATE, TOPIRAMATE

TORSEMIDE, TORSEMIDE

ZONISAMIDE, ZONISAMIDE

* APOTEX INC RICHMOND HILL

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BUDESONIDE, BUDESONIDE

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

FLUNISOLIDE, FLUNISOLIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

RISPERIDONE, RISPERIDONE

* APOTEX INC.

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

APOTEX TECHNOLOGIES

* APOTEX TECHNOLOGIES INC

PAXIL CR, PAROXETINE HYDROCHLORIDE

PAXIL, PAROXETINE HYDROCHLORIDE

APOTHECON

* APOTHECON INC DIV BRISTOL MYERS SQUIBB

KENALOG-10, TRIAMCINOLONE ACETONIDE

KENALOG-40, TRIAMCINOLONE ACETONIDE

APP PHARMS

* APP PHARMACEUTICALS LLC

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

APPCO PHARMA LLC

* APPCO PHARMA LLC

METRONIDAZOLE, METRONIDAZOLE

APRECIA PHARMS CO

* APRECIA PHARMACEUTICALS CO

SPRITAM, LEVETIRACETAM

APTALIS PHARMA US

* APTALIS PHARMA US INC

BENTYL, DICYCLOMINE HYDROCHLORIDE

AQUA PHARMS

* AQUA PHARMACEUTICALS

CORDRAN SP, FLURANDRENOLIDE

CORDRAN, FLURANDRENOLIDE

MONODOX, DOXYCYCLINE

VERDESO, DESONIDE

* AQUA PHARMACEUTICALS LLC

FLUOROPLEX, FLUOROURACIL

XOLEGEL, KETOCONAZOLE

AQUA PHARMS LLC

* AQUA PHARMACEUTICALS LLC

ACTICLATE, DOXYCYCLINE HYCLATE

ARBOR PHARMS IRELAND

* ARBOR PHARMACEUTICALS IRELAND LTD

EDARBI, AZILSARTAN KAMEDOXOMIL

EDARBYCLOR, AZILSARTAN KAMEDOXOMIL

ARBOR PHARMS LLC

* ARBOR PHARMACEUTICALS LLC

BIDIL, HYDRALAZINE HYDROCHLORIDE

E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE

E.E.S., ERYTHROMYCIN ETHYLSUCCINATE

ERY-TAB, ERYTHROMYCIN

ERYPED, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROMYCIN, ERYTHROMYCIN

EVEKEO, AMPHETAMINE SULFATE

GLIADEL, CARMUSTINE

NYMALIZE, NIMODIPINE

PCE, ERYTHROMYCIN

B - 19

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ARBOR PHARMACEUTICALS LLC

SOTYLIZE, SOTALOL HYDROCHLORIDE

ARCO PHARMS LLC

* ARCO PHARMACEUTICALS LLC

THYROSHIELD, POTASSIUM IODIDE

(OTC)

ARDEA BIOSCIENCES

* ARDEA BIOSCIENCES INC

ZURAMPIC, LESINURAD

AREVA PHARMS

* AREVA PHARMACEUTICALS INC

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

ARIAD

* ARIAD PHARMACEUTICALS INC

ICLUSIG, PONATINIB HYDROCHLORIDE

ASCEND THERAPS US

* ASCEND THERAPEUTICS US LLC

ESTROGEL, ESTRADIOL

ASCENT PHARMS INC

* ASCENT PHARMACEUTICALS INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

ASPEN GLOBAL

* ASPEN GLOBAL INC

MYLERAN, BUSULFAN

ASPEN GLOBAL INC

* ASPEN GLOBAL INC

CYCLESSA, DESOGESTREL

LEUKERAN, CHLORAMBUCIL

THIOGUANINE, THIOGUANINE

ASTELLAS

* ASTELLAS PHARMA US INC

ADENOCARD, ADENOSINE

ADENOSCAN, ADENOSINE

AMBISOME, AMPHOTERICIN B

ASTAGRAF XL, TACROLIMUS

CRESEMBA, ISAVUCONAZONIUM SULFATE

LEXISCAN, REGADENOSON

MYCAMINE, MICAFUNGIN SODIUM

PROGRAF, TACROLIMUS

PROTOPIC, TACROLIMUS

VESICARE, SOLIFENACIN SUCCINATE

XTANDI, ENZALUTAMIDE

ASTRAZENECA

* ASTRAZENECA LP

ENTOCORT EC, BUDESONIDE

PULMICORT FLEXHALER, BUDESONIDE

SYMBICORT, BUDESONIDE

* ASTRAZENECA PHARMACEUTICALS LP

ATACAND HCT, CANDESARTAN CILEXETIL

ATACAND, CANDESARTAN CILEXETIL

FASLODEX, FULVESTRANT

SEROQUEL XR, QUETIAPINE FUMARATE

ZOMIG, ZOLMITRIPTAN

ZOMIG-ZMT, ZOLMITRIPTAN

* ASTRAZENECA UK LTD

ARIMIDEX, ANASTROZOLE

CASODEX, BICALUTAMIDE

MERREM, MEROPENEM

ZOLADEX, GOSERELIN ACETATE

ASTRAZENECA AB

* ASTRAZENECA AB

BYDUREON, EXENATIDE SYNTHETIC

BYETTA, EXENATIDE SYNTHETIC

FARXIGA, DAPAGLIFLOZIN PROPANEDIOL

B - 20

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ASTRAZENECA AB

KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE

ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE

SYMLIN, PRAMLINTIDE ACETATE

XIGDUO XR, DAPAGLIFLOZIN PROPANEDIOL

ASTRAZENECA LP

* ASTRAZENECA LP

BRILINTA, TICAGRELOR

NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM

(OTC)

ASTRAZENECA PHARMS

* ASTRAZENECA PHARMACEUTICALS LP

DALIRESP, ROFLUMILAST

EPANOVA, OMEGA-3-CARBOXYLIC ACIDS

IRESSA, GEFITINIB

LYNPARZA, OLAPARIB

MOVANTIK, NALOXEGOL OXALATE

NEXIUM IV, ESOMEPRAZOLE SODIUM

NEXIUM, ESOMEPRAZOLE MAGNESIUM

PRILOSEC OTC, OMEPRAZOLE MAGNESIUM

(OTC)

PRILOSEC, OMEPRAZOLE

PRILOSEC, OMEPRAZOLE MAGNESIUM

PULMICORT RESPULES, BUDESONIDE

RHINOCORT ALLERGY, BUDESONIDE

(OTC)

SEROQUEL, QUETIAPINE FUMARATE

TAGRISSO, OSIMERTINIB MESYLATE

TOPROL-XL, METOPROLOL SUCCINATE

TUDORZA PRESSAIR, ACLIDINIUM BROMIDE

ATLAS PHARMS LLC

* ATLAS PHARMACEUTICALS LLC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ATON

* ATON PHARMA INC

CUPRIMINE, PENICILLAMINE

EDECRIN, ETHACRYNATE SODIUM

EDECRIN, ETHACRYNIC ACID

LACRISERT, HYDROXYPROPYL CELLULOSE

LODOSYN, CARBIDOPA

SYPRINE, TRIENTINE HYDROCHLORIDE

TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE

TIMOPTIC, TIMOLOL MALEATE

ATON PHARMA VPNA

* ATON PHARMA DIV VALEANT PHARMACEUTICALS NORTH AMERICA LLC

DEMSER, METYROSINE

AUROBINDO

* AUROBINDO PHARMA LTD

AMOXICILLIN, AMOXICILLIN

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLARITHROMYCIN, CLARITHROMYCIN

DIDANOSINE, DIDANOSINE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NEVIRAPINE, NEVIRAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARM

* AUROBINDO PHARMA USA INC

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

LEVETIRACETAM, LEVETIRACETAM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

AUROBINDO PHARMA

B - 21

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* AUROBINDO PHARMA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

* AUROBINDO PHARMA LTD

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMPICILLIN SODIUM, AMPICILLIN SODIUM

ATENOLOL, ATENOLOL

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

CARISOPRODOL, CARISOPRODOL

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIDANOSINE, DIDANOSINE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MELOXICAM, MELOXICAM

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RIBAVARIN, RIBAVIRIN

RIBAVIRIN, RIBAVIRIN

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

STAVUDINE, STAVUDINE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TORSEMIDE, TORSEMIDE

TRANDOLAPRIL, TRANDOLAPRIL

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZALEPLON, ZALEPLON

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

AUROBINDO PHARMA LTD

* AUROBINDO PHARMA LIMITED

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

LEVOFLOXACIN, LEVOFLOXACIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

* AUROBINDO PHARMA LTD

B - 22

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* AUROBINDO PHARMA LTD

ABACAVIR SULFATE, ABACAVIR SULFATE

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

ARIPIPRAZOLE, ARIPIPRAZOLE

ATHENTIA NEXT, LEVONORGESTREL

(OTC)

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

AZITHROMYCIN, AZITHROMYCIN

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CEFIXIME, CEFIXIME

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTACAPONE, ENTACAPONE

ENTECAVIR, ENTECAVIR

EPTIFIBATIDE, EPTIFIBATIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

FAMCICLOVIR, FAMCICLOVIR

FAMOTIDINE, FAMOTIDINE

FELODIPINE, FELODIPINE

FINASTERIDE, FINASTERIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

GABAPENTIN, GABAPENTIN

GEMFIBROZIL, GEMFIBROZIL

GLIMEPIRIDE, GLIMEPIRIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METRONIDAZOLE, METRONIDAZOLE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MODAFINIL, MODAFINIL

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NAFCILLIN SODIUM, NAFCILLIN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

OLANZAPINE, OLANZAPINE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXACILLIN SODIUM, OXACILLIN SODIUM

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

B - 23

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 24

PRODUCT NAME SORTED BY APPLICANT

**

**

* AUROBINDO PHARMA LTD

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

REPAGLINIDE, REPAGLINIDE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TELMISARTAN, TELMISARTAN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

* AUROBINDO PHARMA LTD INC

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

MIRTAZAPINE, MIRTAZAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARMA USA

* AUROBINDO PHARMA USA INC

ALPRAZOLAM, ALPRAZOLAM

NAPROXEN, NAPROXEN

OMEPRAZOLE, OMEPRAZOLE

AUROLIFE PHARMA LLC

* AUROLIFE PHARMA LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

AUSTARPHARMA LLC

* AUSTARPHARMA LLC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

METHOCARBAMOL, METHOCARBAMOL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

AUXILIUM PHARMS

* AUXILIUM PHARMACEUTICALS INC

TESTIM, TESTOSTERONE

AUXILIUM PHARMS LLC

* AUXILIUM PHARMACEUTICALS LLC

DILATRATE-SR, ISOSORBIDE DINITRATE

EDEX, ALPROSTADIL

ROBAXIN, METHOCARBAMOL

ROBAXIN-750, METHOCARBAMOL

SEMPREX-D, ACRIVASTINE

STRIANT, TESTOSTERONE

AVACOR PRODS

* AVACOR PRODUCTS LLC

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL

(OTC)

AVANIR PHARMS

* AVANIR PHARMACEUTICALS INC

NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

AVANTHI INC

* AVANTHI INC

CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE

(OTC)

DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, DEXBROMPHENIRAMINE MALEATE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

AVEMA PHARMA

* AVEMA PHARMA SOLUTIONS

IBUPROFEN, IBUPROFEN
(OTC)

AVENT

* AVENT INC

PYTEST KIT, UREA, C-14

PYTEST, UREA, C-14

AVEVA

* AVEVA DRUG DELIVERY SYSTEMS INC

CLONIDINE, CLONIDINE

FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

NICOTINE, NICOTINE
(OTC)

AVID RADIOPHARMS INC

* AVID RADIOPHARMACEUTICALS INC

AMYVID, FLORBETAPIR F-18

**

**

B BRAUN

* B BRAUN MEDICAL INC

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

AMINO ACIDS, AMINO ACIDS

BALANCED SALT, CALCIUM CHLORIDE

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE

CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM

CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE

CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM

CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

B - 25

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 26

PRODUCT NAME SORTED BY APPLICANT

**

**

* B BRAUN MEDICAL INC

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE

FREAMINE HBC 6.9%, AMINO ACIDS

FREAMINE III 10%, AMINO ACIDS

FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS

FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS

FREAMINE III 8.5%, AMINO ACIDS

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPATAMINE 8%, AMINO ACIDS

ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL

METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

NEPHRAMINE 5.4%, AMINO ACIDS

NUTRILIPID 10%, SOYBEAN OIL

NUTRILIPID 20%, SOYBEAN OIL

PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 27

PRODUCT NAME SORTED BY APPLICANT

**

**

* B BRAUN MEDICAL INC

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROCALAMINE, AMINO ACIDS

RESECTISOL IN PLASTIC CONTAINER, MANNITOL

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

TROPHAMINE 10%, AMINO ACIDS

TROPHAMINE, AMINO ACIDS

B BRAUN MEDICAL INC

* B BRAUN MEDICAL INC

MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER, MEROPENEM

BAJAJ MEDICAL LLC

* BAJAJ MECICAL LLC

DYNA-HEX, CHLORHEXIDINE GLUCONATE

(OTC)

BANNER LIFE SCIENCES

* BANNER LIFE SCIENCES LLC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BENZONATATE, BENZONATATE

CALCITRIOL, CALCITRIOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

ETHOSUXIMIDE, ETHOSUXIMIDE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

(OTC)

IBUPROFEN, IBUPROFEN
(OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

MIDOL LIQUID GELS, IBUPROFEN

(OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

NIMODIPINE, NIMODIPINE

PARICALCITOL, PARICALCITOL

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 28

PRODUCT NAME SORTED BY APPLICANT

**

**

* BANNER LIFE SCIENCES LLC

PROGESTERONE, PROGESTERONE

VALPROIC ACID, VALPROIC ACID

VITAMIN D, ERGOCALCIFEROL

ZONISAMIDE, ZONISAMIDE

BANNER PHARMACAPS

* BANNER PHARMACAPS INC

DUTASTERIDE, DUTASTERIDE

BARR

* BARR LABORATORIES INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ARANELLE, ETHINYL ESTRADIOL

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

BALZIVA-28, ETHINYL ESTRADIOL

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CAMILA, NORETHINDRONE

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORZOXAZONE, CHLORZOXAZONE

CLONAZEPAM, CLONAZEPAM

CLONIDINE, CLONIDINE

DANAZOL, DANAZOL

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIAZEPAM, DIAZEPAM

DIDANOSINE, DIDANOSINE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

DUTASTERIDE, DUTASTERIDE

ERRIN, NORETHINDRONE

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

ESTRADIOL AND NORGESTIMATE, ESTRADIOL

ESTROPIPATE, ESTROPIPATE

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

HYDROXYUREA, HYDROXYUREA

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

ISONIAZID, ISONIAZID

JUNEL 1.5/30, ETHINYL ESTRADIOL

JUNEL 1/20, ETHINYL ESTRADIOL

JUNEL FE 1.5/30, ETHINYL ESTRADIOL

JUNEL FE 1/20, ETHINYL ESTRADIOL

KARIVA, DESOGESTREL

KELNOR, ETHINYL ESTRADIOL

LEFLUNOMIDE, LEFLUNOMIDE

LESSINA-28, ETHINYL ESTRADIOL

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NIACIN, NIACIN

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 29

PRODUCT NAME SORTED BY APPLICANT

**

**

* BARR LABORATORIES INC

NORTREL 0.5/35-28, ETHINYL ESTRADIOL

NORTREL 1/35-21, ETHINYL ESTRADIOL

NORTREL 1/35-28, ETHINYL ESTRADIOL

NORTREL 7/7/7, ETHINYL ESTRADIOL

ONDANSETRON, ONDANSETRON

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PORTIA-28, ETHINYL ESTRADIOL

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

SPRINTEC, ETHINYL ESTRADIOL

TEMOZOLOMIDE, TEMOZOLOMIDE

TREXALL, METHOTREXATE SODIUM

TRI-LEGEST 21, ETHINYL ESTRADIOL

TRI-LEGEST FE, ETHINYL ESTRADIOL

TRI-SPRINTEC, ETHINYL ESTRADIOL

WARFARIN SODIUM, WARFARIN SODIUM

* BARR PHARMACEUTICALS

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

BARR LABS DIV TEVA

* BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

BUDESONIDE, BUDESONIDE

OXYBUTYNIN, OXYBUTYNIN

BARR LABS INC

* BARR LABORATORIES INC

ACITRETIN, ACITRETIN

CLOZAPINE, CLOZAPINE

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ESTRADIOL, ESTRADIOL

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NIMODIPINE, NIMODIPINE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OLANZAPINE, OLANZAPINE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

TRETINOIN, TRETINOIN

TRI LO SPRINTEC, ETHINYL ESTRADIOL

BAUSCH AND LOMB

* BAUSCH AND LOMB INC

ALAWAY, KETOTIFEN FUMARATE

(OTC)

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALREX, LOTEPREDNOL ETABONATE

BESIVANCE, BESIFLOXACIN HYDROCHLORIDE

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

ISTALOL, TIMOLOL MALEATE

LATANOPROST, LATANOPROST

LOTEMAX, LOTEPREDNOL ETABONATE

MIOCHOL-E, ACETYLCHOLINE CHLORIDE

OFLOXACIN, OFLOXACIN

OPCON-A, NAPHAZOLINE HYDROCHLORIDE

(OTC)

PROLENSA, BROMFENAC SODIUM

RETISERT, FLUOCINOLONE ACETONIDE

TIMOLOL MALEATE, TIMOLOL MALEATE

VITRASE, HYALURONIDASE

ZIRGAN, GANCICLOVIR

ZYLET, LOTEPREDNOL ETABONATE

* BAUSCH AND LOMB PHARMACEUTICALS INC

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 30

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAUSCH AND LOMB PHARMACEUTICALS INC

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CROLOM, CROMOLYN SODIUM

CROMOLYN SODIUM, CROMOLYN SODIUM

CROMOLYN SODIUM, CROMOLYN SODIUM

(OTC)

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXASPORIN, DEXAMETHASONE

ERYTHROMYCIN, ERYTHROMYCIN

FLUNISOLIDE, FLUNISOLIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

OFLOXACIN, OFLOXACIN

OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

OTICAIR, HYDROCORTISONE

PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE

TOBRAMYCIN, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TROPICAMIDE, TROPICAMIDE

BAUSCH AND LOMB INC

* BAUSCH AND LOMB INC

BEPREVE, BEPOTASTINE BESILATE

LOTEMAX, LOTEPREDNOL ETABONATE

PODOFILOX, PODOFILOX

BAXTER HLTHCARE

* BAXTER HEALTHCARE CORP

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE

ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC, ESMOLOL HYDROCHLORIDE

CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CEFAZOLIN IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC

CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC

CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 31

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAXTER HEALTHCARE CORP

CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

CLINOLIPID 20%, OLIVE OIL

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

CYTOXAN (LYOPHILIZED), CYCLOPHOSPHAMIDE

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 32

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAXTER HEALTHCARE CORP

ETHRANE, ENFLURANE

EXTRANEAL, ICODEXTRIN

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FORANE, ISOFLURANE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

IFEX, IFOSFAMIDE

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

MESNEX, MESNA

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM

NEXTERONE, AMIODARONE HYDROCHLORIDE

NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN

OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 10% IN WATER, MANNITOL

OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 15% IN WATER, MANNITOL

OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 20% IN WATER, MANNITOL

OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 5% IN WATER, MANNITOL

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAXTER HEALTHCARE CORP

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SEVOFLURANE, SEVOFLURANE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

STERILE WATER, STERILE WATER FOR IRRIGATION

SUPRANE, DESFLURANE

TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE

TIS-U-SOL, MAGNESIUM SULFATE

TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

BAXTER HLTHCARE CORP

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE

* BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

BAYER

* BAYER HEALTHCARE LLC

ALEVE, NAPROXEN SODIUM

(OTC)

ALEVE-D SINUS & COLD, NAPROXEN SODIUM

(OTC)

FEMSTAT 3, BUTOCONAZOLE NITRATE

(OTC)

BAYER HEALTHCARE LLC

* BAYER HEALTHCARE LLC

CHILDREN'S CLARITIN, LORATADINE

(OTC)

CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE

(OTC)

CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE

(OTC)

CLARITIN HIVES RELIEF REDITAB, LORATADINE

(OTC)

CLARITIN HIVES RELIEF, LORATADINE

(OTC)

CLARITIN REDITABS, LORATADINE

(OTC)

CLARITIN, LORATADINE
(OTC)

CLARITIN-D 24 HOUR, LORATADINE

(OTC)

CLARITIN-D, LORATADINE
(OTC)

GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE

(OTC)

GYNE-LOTRIMIN 3, CLOTRIMAZOLE
(OTC)

GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE

(OTC)

GYNE-LOTRIMIN, CLOTRIMAZOLE
(OTC)

LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE

(OTC)

MIRALAX, POLYETHYLENE GLYCOL 3350

(OTC)

MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE

(OTC)

MYCELEX-7, CLOTRIMAZOLE
(OTC)

OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE

(OTC)

OXYTROL FOR WOMEN, OXYBUTYNIN

(OTC)

SHADE UVAGUARD, AVOBENZONE

(OTC)

ZEGERID OTC, OMEPRAZOLE

(OTC)

BAYER HLTHCARE

* BAYER HEALTHCARE CONSUMER CARE

ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE

(OTC)

* BAYER HEALTHCARE PHARMACEUTICALS INC

B - 33

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAYER HEALTHCARE PHARMACEUTICALS INC

ADALAT CC, NIFEDIPINE

ADEMPAS, RIOCIGUAT

ANGELIQ, DROSPIRENONE

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE

AVELOX, MOXIFLOXACIN HYDROCHLORIDE

BEYAZ, DROSPIRENONE

BILTRICIDE, PRAZIQUANTEL

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN HYDROCHLORIDE

CLIMARA PRO, ESTRADIOL

CLIMARA, ESTRADIOL

DESONATE, DESONIDE

DTIC-DOME, DACARBAZINE

EOVIST, GADOXETATE DISODIUM

FINACEA , AZELAIC ACID

FINACEA, AZELAIC ACID

GADAVIST, GADOBUTROL

LEVITRA, VARDENAFIL HYDROCHLORIDE

MAGNEVIST, GADOPENTETATE DIMEGLUMINE

MENOSTAR, ESTRADIOL

MIRENA, LEVONORGESTREL

NATAZIA, DIENOGEST

NEXAVAR, SORAFENIB TOSYLATE

PRECOSE, ACARBOSE

SAFYRAL, DROSPIRENONE

SKYLA, LEVONORGESTREL

STAXYN, VARDENAFIL HYDROCHLORIDE

STIVARGA, REGORAFENIB

ULTRAVIST (PHARMACY BULK), IOPROMIDE

ULTRAVIST 150, IOPROMIDE

ULTRAVIST 240, IOPROMIDE

ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE

ULTRAVIST 300, IOPROMIDE

ULTRAVIST 370, IOPROMIDE

XOFIGO, RADIUM RA-223 DICHLORIDE

YASMIN, DROSPIRENONE

YAZ, DROSPIRENONE

BAYSHORE PHARMS LLC

* BAYSHORE PHARMACEUTICALS LLC

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

BD RX

* BD RX INC

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

BECTON DICKINSON

* BECTON DICKINSON AND CO

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

(OTC)

E-Z SCRUB 201, POVIDONE-IODINE

(OTC)

E-Z SCRUB 241, POVIDONE-IODINE

(OTC)

BEDFORD

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

BUMETANIDE, BUMETANIDE

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CEFTRIAXONE, CEFTRIAXONE SODIUM

B - 34

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

ETOMIDATE, ETOMIDATE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MITOMYCIN, MITOMYCIN

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

VALPROATE SODIUM, VALPROATE SODIUM

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

BEDFORD LABS

* BEDFORD LABORATORIES

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUMAZENIL, FLUMAZENIL

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LORAZEPAM PRESERVATIVE FREE, LORAZEPAM

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

BELCHER PHARMS

* BELCHER PHARMACEUTICALS LLC

CEPHALEXIN, CEPHALEXIN

DESLORATADINE, DESLORATADINE

BELCHER PHARMS LLC

* BELCHER PHARMACEUTICALS LLC

EPINEPHRINE, EPINEPHRINE HYDROCHLORIDE

BEXIMCO USA

* BEXIMCO PHARMACEUTICALS USA INC

CARVEDILOL, CARVEDILOL

BIO NUCLEONICS

* BIO NUCLEONICS INC

STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89

BIO PHARM INC

* BIO PHARM INC

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

BIO-PHARM INC

* BIO-PHARM INC

LACTULOSE, LACTULOSE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

BIOCODEX INC

* BIOCODEX INC

B - 35

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BIOCODEX INC

TOTECT, DEXRAZOXANE HYDROCHLORIDE

BIOCON LIMITED

* BIOCON LIMITED

SIMVASTATIN, SIMVASTATIN

BIOCRYST

* BIOCRYST PHARMACEUTICALS INC

RAPIVAB, PERAMIVIR

BIODELIVERY SCI INTL

* BIODELIVERY SCIENCES INTERNATIONAL INC

BUNAVAIL, BUPRENORPHINE HYDROCHLORIDE

BIOGEN IDEC INC

* BIOGEN IDEC INC

TECFIDERA, DIMETHYL FUMARATE

BIOKEY

* BIOKEY INC

CILOSTAZOL, CILOSTAZOL

BIOMARIN PHARM

* BIOMARIN PHARMACEUTICAL INC

KUVAN, SAPROPTERIN DIHYDROCHLORIDE

BIOMEDCL RES FDN

* BIOMEDICAL RESEARCH FOUNDATION NORTHWEST LOUISANA

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

BIONPHARMA INC

* BIONPHARMA INC

BEXAROTENE, BEXAROTENE

BLAIREX

* BLAIREX LABORATORIES INC

BRONCHO SALINE, SODIUM CHLORIDE

(OTC)

BLU CARIBE

* BLU CARIBE INC

GEMFIBROZIL, GEMFIBROZIL

BLU CARIBE INC

* BLU CARIBE INC

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

BOEHRINGER INGELHEIM

* BOEHRINGER INGELHEIM

CATAPRES, CLONIDINE HYDROCHLORIDE

CATAPRES-TTS-1, CLONIDINE

CATAPRES-TTS-2, CLONIDINE

CATAPRES-TTS-3, CLONIDINE

GILOTRIF, AFATINIB DIMALEATE

GLYXAMBI, EMPAGLIFLOZIN

MICARDIS HCT, HYDROCHLOROTHIAZIDE

MICARDIS, TELMISARTAN

MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE

ZANTAC 150, RANITIDINE HYDROCHLORIDE

(OTC)

ZANTAC 75, RANITIDINE HYDROCHLORIDE

(OTC)

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC

AGGRENOX, ASPIRIN

APTIVUS, TIPRANAVIR

ATROVENT HFA, IPRATROPIUM BROMIDE

ATROVENT, IPRATROPIUM BROMIDE

COMBIVENT RESPIMAT, ALBUTEROL SULFATE

FLOMAX, TAMSULOSIN HYDROCHLORIDE

JARDIANCE, EMPAGLIFLOZIN

JENTADUETO, LINAGLIPTIN

MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE

MOBIC, MELOXICAM

OFEV, NINTEDANIB ESYLATE

PERSANTINE, DIPYRIDAMOLE

PRADAXA, DABIGATRAN ETEXILATE MESYLATE

B - 36

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC

SPIRIVA RESPIMAT, TIOTROPIUM BROMIDE

SPIRIVA, TIOTROPIUM BROMIDE

STIOLTO RESPIMAT, OLODATEROL HYDROCHLORIDE

STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE

SYNJARDY, EMPAGLIFLOZIN

TRADJENTA, LINAGLIPTIN

TWYNSTA, AMLODIPINE BESYLATE

VIRAMUNE XR, NEVIRAPINE

VIRAMUNE, NEVIRAPINE

BRACCO

* BRACCO DIAGNOSTICS INC

CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82

CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT

CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE

CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE

CYSTOGRAFIN, DIATRIZOATE MEGLUMINE

GASTROGRAFIN, DIATRIZOATE MEGLUMINE

ISOVUE-200, IOPAMIDOL

ISOVUE-250, IOPAMIDOL

ISOVUE-300, IOPAMIDOL

ISOVUE-370, IOPAMIDOL

ISOVUE-M 200, IOPAMIDOL

ISOVUE-M 300, IOPAMIDOL

KINEVAC, SINCALIDE

LUMASON, SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT

MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE

MULTIHANCE, GADOBENATE DIMEGLUMINE

PROHANCE MULTIPACK, GADOTERIDOL

PROHANCE, GADOTERIDOL

RENOGRAFIN-76, DIATRIZOATE MEGLUMINE

SINOGRAFIN, DIATRIZOATE MEGLUMINE

BRAINTREE

* BRAINTREE LABORATORIES INC

AXID, NIZATIDINE

GOLYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350

BRAINTREE LABS

* BRAINTREE LABORATORIES INC

SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS

BRECKENRIDGE PHARM

* BRECKENRIDGE PHARMACEUTICAL INC

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CILOSTAZOL, CILOSTAZOL

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

LEVETIRACETAM, LEVETIRACETAM

MEFENAMIC ACID, MEFENAMIC ACID

MELOXICAM, MELOXICAM

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

OXCARBAZEPINE, OXCARBAZEPINE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

BRECKENRIDGE PHARMS

* BRECKENRIDGE PHARMACEUTICALS INC

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BRIGHAM WOMENS

B - 37

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BRIGHAM AND WOMENS HOSP

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

BRIGHAM WOMENS HOSP

* BRIGHAM AND WOMENS HOSP INC

AMMONIA N 13, AMMONIA N-13

BRISTOL MYERS SQUIBB

* BRISTOL MYERS SQUIBB

AZACTAM, AZTREONAM

BARACLUDE, ENTECAVIR

EVOTAZ, ATAZANAVIR SULFATE

GLUCOVANCE, GLYBURIDE

LYSODREN, MITOTANE

MEGACE, MEGESTROL ACETATE

PRAVACHOL, PRAVASTATIN SODIUM

* BRISTOL MYERS SQUIBB CO

AZACTAM IN PLASTIC CONTAINER, AZTREONAM

DROXIA, HYDROXYUREA

GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE

HYDREA, HYDROXYUREA

REYATAZ, ATAZANAVIR SULFATE

SPRYCEL, DASATINIB

SUSTIVA, EFAVIRENZ

VIDEX EC, DIDANOSINE

* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

ELIQUIS, APIXABAN

ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE

GLUCOPHAGE, METFORMIN HYDROCHLORIDE

VIDEX, DIDANOSINE

ZERIT, STAVUDINE

* BRISTOL MYERS SQUIBB PHARMA CO

COUMADIN, WARFARIN SODIUM

BRISTOL-MYERS SQUIBB

* BRISTOL-MYERS SQUIBB CO

DAKLINZA, DACLATASVIR DIHYDROCHLORIDE

BRYAN

* BRYAN CORP

SCLEROSOL, TALC

TALC, TALC

**

**

CADILA PHARMS LTD

* CADILA PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

FOLIC ACID, FOLIC ACID

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

OFLOXACIN, OFLOXACIN

CADISTA PHARMS

* CADISTA PHARMACEUTICALS INC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

LAMOTRIGINE, LAMOTRIGINE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

OXCARBAZEPINE, OXCARBAZEPINE

CALL INC

* CALL INC DBA ROCHESTER PHARMACEUTICALS

ADAPALENE, ADAPALENE

CARACO

* CARACO PHARMACEUTICAL LABORATORIES LTD

BACLOFEN, BACLOFEN

FLUMADINE, RIMANTADINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

CARDINAL HEALTH 414

B - 38

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* CARDINAL HEALTH 414 LLC

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

* CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

CARDINAL HEALTH 418

* CARDINAL HEALTH 418 INC

SODIUM IODIDE I 123, SODIUM IODIDE I-123

CAREFUSION

* CAREFUSION 213 LLC

CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE

(OTC)

CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE

(OTC)

PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE

(OTC)

CARLSBAD

* CARLSBAD TECHNOLOGY INC

ACYCLOVIR, ACYCLOVIR

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FAMOTIDINE, FAMOTIDINE

GLIMEPIRIDE, GLIMEPIRIDE

LOVASTATIN, LOVASTATIN

MELOXICAM, MELOXICAM

MODAFINIL, MODAFINIL

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

CAROLINA MEDCL

* CAROLINA MEDICAL PRODUCTS CO

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE

ISONIAZID, ISONIAZID

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

SPS, SODIUM POLYSTYRENE SULFONATE

TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE

CATALENT

* CATALENT PHARMA SOLUTIONS LLC

VALPROIC ACID, VALPROIC ACID

CEDAR PHARMS

* CEDAR PHARMACEUTICALS LLC

METHIMAZOLE, METHIMAZOLE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

CELGENE

* CELGENE CORP

ISTODAX, ROMIDEPSIN

POMALYST, POMALIDOMIDE

REVLIMID, LENALIDOMIDE

THALOMID, THALIDOMIDE

VIDAZA, AZACITIDINE

CELGENE CORP

* CELGENE CORP

OTEZLA, APREMILAST

CEPHALON

* CEPHALON INC

ACTIQ, FENTANYL CITRATE

FENTORA, FENTANYL CITRATE

GABITRIL, TIAGABINE HYDROCHLORIDE

NUVIGIL, ARMODAFINIL

PROVIGIL, MODAFINIL

TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRISENOX, ARSENIC TRIOXIDE

B - 39

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

CEREXA

* CEREXA INC

TEFLARO, CEFTAROLINE FOSAMIL

CEREXA INC

* CEREXA INC

AVYCAZ, AVIBACTAM SODIUM

CHARTWELL LIFE SCI

* CHARTWELL LIFE SCIENCE LLC

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

CHATTEM

* CHATTEM INC

SELSUN, SELENIUM SULFIDE

UNISOM, DOXYLAMINE SUCCINATE

(OTC)

CHEM WERTH INC

* CHEM WERTH INC

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

CHEMISCH FBRK KRSSLR

* CHEMISCHE FABRIK KREUSSLER & CO. GMBH

ASCLERA, POLIDOCANOL

CHIESI USA INC

* CHIESI USA INC

BETHKIS, TOBRAMYCIN

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE, NICARDIPINE HYDROCHLORIDE

CUROSURF, PORACTANT ALFA

ZYFLO CR, ZILEUTON

ZYFLO, ZILEUTON

CHILDRENS HOSP MI

* CHILDRENS HOSP MICHIGAN

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

CHINA RESOURCES

* CHINA RESOURCES SAIKE PHARMACEUTICAL CO LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CHIRHOCLIN

* CHIRHOCLIN INC

CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN

CIPHER PHARMS INC

* CIPHER PHARMACEUTICALS INC

CONZIP, TRAMADOL HYDROCHLORIDE

LIPOFEN, FENOFIBRATE

CIPLA

* CIPLA LTD

NEVIRAPINE, NEVIRAPINE

RISPERIDONE, RISPERIDONE

ZIDOVUDINE, ZIDOVUDINE

CIPLA LTD

* CIPLA LTD

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

CARBOPLATIN, CARBOPLATIN

CARVEDILOL, CARVEDILOL

CELECOXIB, CELECOXIB

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CICLOPIROX, CICLOPIROX

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

B - 40

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* CIPLA LTD

FAMCICLOVIR, FAMCICLOVIR

FINASTERIDE, FINASTERIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IRBESARTAN, IRBESARTAN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

MELOXICAM, MELOXICAM

NEVIRAPINE, NEVIRAPINE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

STAVUDINE, STAVUDINE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

ZALEPLON, ZALEPLON

ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

CITIUS PHARMS

* CITIUS PHARMACEUTICALS LLC

SUPRENZA, PHENTERMINE HYDROCHLORIDE

CITRON PHARMA LLC

* CITRON PHARMA LLC

CORTISPORIN, HYDROCORTISONE

CLARIS LIFESCIENCES

* CLARIS LIFESCIENCES LTD

FUROSEMIDE, FUROSEMIDE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

CLARIS PHARMASERVICE

* CLARIS PHARMASERVICES

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOFLOXACIN, LEVOFLOXACIN

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

CLINIGEN HLTHCARE

* CLINIGEN HEALTHCARE LTD

ETHYOL, AMIFOSTINE

FOSCAVIR, FOSCARNET SODIUM

CLOVER PHARMS

* CLOVER PHARMACEUTICALS CORP

AMICAR, AMINOCAPROIC ACID

CNTY LINE PHARMS

* COUNTY LINE PHARMACEUTICALS LLC

DYNACIN, MINOCYCLINE HYDROCHLORIDE

LIDEX, FLUOCINONIDE

LOPROX, CICLOPIROX

TRANDATE, LABETALOL HYDROCHLORIDE

UREX, METHENAMINE HIPPURATE

COASTAL PHARMS

* COASTAL PHARMACEUTICALS

BROMFENAC SODIUM, BROMFENAC SODIUM

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE, ASPIRIN

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE,CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

B - 41

B - 42

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* COASTAL PHARMACEUTICALS

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE

NYSTATIN, NYSTATIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE AND ASPIRIN, ASPIRIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

COLGATE

* COLGATE ORAL PHARMACEUTICALS INC

PERIOGARD, CHLORHEXIDINE GLUCONATE

COLGATE PALMOLIVE

* COLGATE PALMOLIVE

COLGATE TOTAL, SODIUM FLUORIDE

(OTC)

CONCORDIA LABS INC

* CONCORDIA LABORATORIES INC

PHOTOFRIN, PORFIMER SODIUM

CONCORDIA PHARMS INC

* CONCORDIA PHARMACEUTICALS INC

DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE

DUTOPROL, HYDROCHLOROTHIAZIDE

DYRENIUM, TRIAMTERENE

KAPVAY, CLONIDINE HYDROCHLORIDE

KAYEXALATE, SODIUM POLYSTYRENE SULFONATE

LANOXIN, DIGOXIN

NILANDRON, NILUTAMIDE

ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE

ORAPRED, PREDNISOLONE SODIUM PHOSPHATE

PARNATE, TRANYLCYPROMINE SULFATE

PLAQUENIL, HYDROXYCHLOROQUINE SULFATE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE

ZANTAC, RANITIDINE HYDROCHLORIDE

ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM

ZINACEF, CEFUROXIME SODIUM

CONTRACT PHARMACAL

* CONTRACT PHARMACAL CORP

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CIMETIDINE, CIMETIDINE
(OTC)

FOLIC ACID, FOLIC ACID

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN

(OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN
(OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

PREDNISONE, PREDNISONE

PROFEN, IBUPROFEN
(OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

CORCEPT THERAP

* CORCEPT THERAPEUTICS INC

KORLYM, MIFEPRISTONE

CORDEN PHARMA

* CORDEN PHARMA LATINA SPA

GLEOSTINE, LOMUSTINE

COREPHARMA

* COREPHARMA LLC

ALPRAZOLAM, ALPRAZOLAM

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE,

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

FELBAMATE, FELBAMATE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

AMPHETAMINE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* COREPHARMA LLC

GLYBURIDE, GLYBURIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LEVOCARNITINE, LEVOCARNITINE

METAXALONE, METAXALONE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MOLINDONE HYDROCHLORIDE, MOLINDONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PHENYTOIN, PHENYTOIN

POTASSIUM CITRATE, POTASSIUM CITRATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

URSODIOL, URSODIOL

COVIS INJECTABLES

* COVIS INJECTABLES SARL

LANOXIN PEDIATRIC, DIGOXIN

LANOXIN, DIGOXIN

COVIS PHARMA SARL

* COVIS PHARMA SARL

ALTOPREV, LOVASTATIN

BETAPACE AF, SOTALOL HYDROCHLORIDE

BETAPACE, SOTALOL HYDROCHLORIDE

RILUTEK, RILUZOLE

CPDC

* CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

CPPI CV

* CP PHARMACEUTICALS INTERNATIONAL CV

SUTENT, SUNITINIB MALATE

CRANFORD PHARMS LLC

* CRANFORD PHARMACEUTICALS LLC

INDERAL LA, PROPRANOLOL HYDROCHLORIDE

CREALTA PHARMS LLC

* CREALTA PHARMACEUTICALS LLC

MIGERGOT, CAFFEINE

CROWN LABS

* CROWN LABORATORIES INC

ALA-CORT, HYDROCORTISONE

ALA-SCALP, HYDROCORTISONE

TRIDERM, TRIAMCINOLONE ACETONIDE

CSL BEHRING

* CSL BEHRING LLC

STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

CSPC NBP PHARM CO

* CSPC NBP PHARMACEUTICAL CO LTD

BENZONATATE, BENZONATATE

CSPC OUYI PHARM CO

* CSPC OUYI PHARMACEUTICAL CO LTD

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

CUBIST

* CUBIST PHARMACEUTICALS INC

CUBICIN, DAPTOMYCIN

CUBIST PHARMS

* CUBIST PHARMACEUTICALS INC

ENTEREG, ALVIMOPAN

CUBIST PHARMS LLC

* CUBIST PHARMACEUTICALS LLC

DIFICID, FIDAXOMICIN

SIVEXTRO, TEDIZOLID PHOSPHATE

B - 43

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* CUBIST PHARMACEUTICALS LLC

ZERBAXA, CEFTOLOZANE SULFATE

CUMBERLAND PHARMS

* CUMBERLAND PHARMACEUTICALS INC

ACETADOTE, ACETYLCYSTEINE

CALDOLOR, IBUPROFEN

LACTULOSE, LACTULOSE

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE

CUSTOPHARM INC

* CUSTOPHARM INC

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

CYPRESS BIOSCIENCE

* CYPRESS BIOSCIENCE INC

SAVELLA, MILNACIPRAN HYDROCHLORIDE

CYPRESS PHARM

* CYPRESS PHARMACEUTICAL INC

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

ELIPHOS, CALCIUM ACETATE

REZIRA, HYDROCODONE BITARTRATE

VITUZ, CHLORPHENIRAMINE MALEATE

ZUTRIPRO, CHLORPHENIRAMINE MALEATE

**

**

DAEWOONG PHARM CO

* DAEWOONG PHARMACEUTICAL CO LTD

MEROPENEM, MEROPENEM

DAIICHI

* DAIICHI PHARMACEUTICAL CORP

FLOXIN OTIC, OFLOXACIN

DAIICHI SANKYO

* DAIICHI SANKYO INC

AZOR, AMLODIPINE BESYLATE

BENICAR HCT, HYDROCHLOROTHIAZIDE

BENICAR, OLMESARTAN MEDOXOMIL

EVOXAC, CEVIMELINE HYDROCHLORIDE

SAVAYSA, EDOXABAN TOSYLATE

TRIBENZOR, AMLODIPINE BESYLATE

WELCHOL, COLESEVELAM HYDROCHLORIDE

DANCO LABS LLC

* DANCO LABORATORIES LLC

MIFEPREX, MIFEPRISTONE

DARA BIOSCIENCES

* DARA BIOSCIENCES INC

ORAVIG, MICONAZOLE

SOLTAMOX, TAMOXIFEN CITRATE

DAVA INTL INC

* DAVA INTERNATIONAL INC

ALPRAZOLAM, ALPRAZOLAM

DAVA PHARMS INC

* DAVA PHARMACEUTICALS INC

ACYCLOVIR, ACYCLOVIR

AMOXICILLIN, AMOXICILLIN

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

ATENOLOL, ATENOLOL

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

GEMFIBROZIL, GEMFIBROZIL

GLYBURIDE (MICRONIZED), GLYBURIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

MORPHINE SULFATE, MORPHINE SULFATE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

B - 44

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* DAVA PHARMACEUTICALS INC

PROPYLTHIOURACIL, PROPYLTHIOURACIL

PYRAZINAMIDE, PYRAZINAMIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

VOSPIRE ER, ALBUTEROL SULFATE

DAVIS AND GECK

* DAVIS AND GECK DIV AMERICAN CYANAMID CO

PRE-OP II, HEXACHLOROPHENE

PRE-OP, HEXACHLOROPHENE

DELCOR ASSET

* DELCOR ASSET CORP

EVOCLIN, CLINDAMYCIN PHOSPHATE

LUXIQ, BETAMETHASONE VALERATE

OLUX E, CLOBETASOL PROPIONATE

OLUX, CLOBETASOL PROPIONATE

VUSION, MICONAZOLE NITRATE

ZOVIRAX, ACYCLOVIR

DELCOR ASSET CORP

* DELCOR ASSET CORP

ERYGEL, ERYTHROMYCIN

EXTINA, KETOCONAZOLE

KENALOG, TRIAMCINOLONE ACETONIDE

ZONALON, DOXEPIN HYDROCHLORIDE

DENCO ASSET

* DENCO ASSET LLC

DENAVIR, PENCICLOVIR SODIUM

DENTSPLY PHARM

* DENTSPLY PHARMACEUTICAL INC

CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE

ORAQIX, LIDOCAINE

DEPOMED INC

* DEPOMED INC

CAMBIA, DICLOFENAC POTASSIUM

GRALISE, GABAPENTIN

LAZANDA, FENTANYL CITRATE

NUCYNTA ER, TAPENTADOL HYDROCHLORIDE

NUCYNTA, TAPENTADOL HYDROCHLORIDE

ZIPSOR, DICLOFENAC POTASSIUM

DEPROCO

* DEPROCO INC

LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE

LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE

SCANDONEST L, LEVONORDEFRIN

SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE

SEPTOCAINE, ARTICAINE HYDROCHLORIDE

DEXCEL LTD

* DEXCEL LTD

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

DEXCEL PHARMA

* DEXCEL PHARMA TECHNOLOGIES LTD

LEVETIRACETAM, LEVETIRACETAM

OMEPRAZOLE, OMEPRAZOLE
(OTC)

PERIOCHIP, CHLORHEXIDINE GLUCONATE

DIALYSIS SUPS

* DIALYSIS SUPPLIES INC

NORMOCARB HF 25, MAGNESIUM CHLORIDE

NORMOCARB HF 35, MAGNESIUM CHLORIDE

DIGESTIVE CARE INC

* DIGESTIVE CARE INC

PERTZYE, PANCRELIPASE (AMYLASE

DORADO PHARMA

* DORADO PHARMA LLC

KETOPROFEN, KETOPROFEN

B - 45

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

DORC

* DORC INTERNATIONAL BV

MEMBRANEBLUE, TRYPAN BLUE

VISIONBLUE, TRYPAN BLUE

DOUGLAS PHARMS

* DOUGLAS PHARMACEUTICALS AMERICA LTD

MYORISAN, ISOTRETINOIN

DOW PHARM

* DOW PHARMACEUTICAL SCIENCES

ACANYA, BENZOYL PEROXIDE

AKNE-MYCIN, ERYTHROMYCIN

ATRALIN, TRETINOIN

JUBLIA, EFINACONAZOLE

NUTRACORT, HYDROCORTISONE

ONEXTON, BENZOYL PEROXIDE

OXSORALEN-ULTRA, METHOXSALEN

DR REDDYS LA

* DR REDDYS LABORATORIES LOUISIANA LLC

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN
(OTC)

LOPURIN, ALLOPURINOL

SSD AF, SILVER SULFADIAZINE

SSD, SILVER SULFADIAZINE

DR REDDYS LABS INC

* DR REDDYS LABORATORIES INC

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMOXIL, AMOXICILLIN

AUGMENTIN '125', AMOXICILLIN

AUGMENTIN '200', AMOXICILLIN

AUGMENTIN '250', AMOXICILLIN

AUGMENTIN '400', AMOXICILLIN

AUGMENTIN '500', AMOXICILLIN

AUGMENTIN '875', AMOXICILLIN

AUGMENTIN ES-600, AMOXICILLIN

AUGMENTIN XR, AMOXICILLIN

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HABITROL, NICOTINE
(OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN
(OTC)

LAROTID, AMOXICILLIN

LEVOFLOXACIN, LEVOFLOXACIN

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM

(OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SIMVASTATIN, SIMVASTATIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

DR REDDYS LABS LTD

* DR REDDYS LABORATORIES LIMITED

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

* DR REDDYS LABORATORIES LTD

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

B - 46

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* DR REDDYS LABORATORIES LTD

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZACITIDINE, AZACITIDINE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DECITABINE, DECITABINE

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOCETAXEL, DOCETAXEL

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESZOPICLONE, ESZOPICLONE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE
(OTC)

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE

(OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN

(OTC)

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE, LANSOPRAZOLE
(OTC)

LATANOPROST, LATANOPROST

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

NAPROXEN SODIUM, NAPROXEN SODIUM

NATEGLINIDE, NATEGLINIDE

NIZATIDINE, NIZATIDINE

OFLOXACIN, OFLOXACIN

OLANZAPINE, OLANZAPINE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM

(OTC)

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXAPROZIN, OXAPROZIN

B - 47

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* DR REDDYS LABORATORIES LTD

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SIROLIMUS, SIROLIMUS

TACROLIMUS, TACROLIMUS

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ZAFIRLUKAST, ZAFIRLUKAST

ZENATANE, ISOTRETINOIN

ZOLEDRONIC ACID, ZOLEDRONIC ACID

DR REDDYS LABS SA

* DR REDDYS LABORATORIES SA

FENOFIBRATE (MICRONIZED), FENOFIBRATE

DRAXIMAGE

* DRAXIMAGE INC

DTPA, TECHNETIUM TC-99M PENTETATE KIT

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

DUCHESNAY

* DUCHESNAY INC

DICLEGIS, DOXYLAMINE SUCCINATE

DURAMED PHARMS BARR

* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

AVIANE-28, ETHINYL ESTRADIOL

CRYSELLE, ETHINYL ESTRADIOL

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

ENPRESSE-28, ETHINYL ESTRADIOL

METHYLPREDNISOLONE, METHYLPREDNISOLONE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VELIVET, DESOGESTREL

DURAMED RES

* DURAMED RESEARCH INC

AYGESTIN, NORETHINDRONE ACETATE

DURATA THERAPS INTL

* DURATA THERAPEUTICS INTERNATIONAL BV

DALVANCE, DALBAVANCIN HYDROCHLORIDE

DUSA

* DUSA PHARMACEUTICALS INC

LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE

REDDYS

* DOCTOR REDDYS LABORATORIES LTD

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

**

**

EAGLE PHARMS

* EAGLE PHARMACEUTICALS INC

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

BENDEKA, BENDAMUSTINE HYDROCHLORIDE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

RYANODEX, DANTROLENE SODIUM

B - 48

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

EASTMAN KODAK

* EASTMAN KODAK CO

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

EBEWE PHARMA

* EBEWE PHARMA GES MBH NFG KG

CARBOPLATIN, CARBOPLATIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

ECLAT PHARMS LLC

* ECLAT PHARMACEUTICALS LLC

BLOXIVERZ, NEOSTIGMINE METHYLSULFATE

VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE

ECOLAB

* ECOLAB INC

CHG SCRUB, CHLORHEXIDINE GLUCONATE

(OTC)

CIDA-STAT, CHLORHEXIDINE GLUCONATE

(OTC)

ECR

* ECR PHARMACEUTICALS

DEXAMETHASONE, DEXAMETHASONE

ECR PHARMA

* ECR PHARMA

TUSSICAPS, CHLORPHENIRAMINE POLISTIREX

EDENBRIDGE PHARMS

* EDENBRIDGE PHARMACEUTICALS LLC

IVERMECTIN, IVERMECTIN

TINIDAZOLE, TINIDAZOLE

EDGEMONT PHARMS LLC

* EDGEMONT PHARMACEUTICALS LLC

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FORFIVO XL, BUPROPION HYDROCHLORIDE

EDISON THERAPS LLC

* EDISON THERAPEUTICS LLC

METHERGINE, METHYLERGONOVINE MALEATE

EGALET US INC

* EGALET US INC

OXAYDO, OXYCODONE HYDROCHLORIDE

SPRIX, KETOROLAC TROMETHAMINE

EI INC

* EI INC

THEROXIDIL, MINOXIDIL
(OTC)

EISAI INC

* EISAI INC

ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM

ACIPHEX, RABEPRAZOLE SODIUM

ARICEPT ODT, DONEPEZIL HYDROCHLORIDE

ARICEPT, DONEPEZIL HYDROCHLORIDE

BANZEL, RUFINAMIDE

BELVIQ, LORCASERIN HYDROCHLORIDE

FYCOMPA, PERAMPANEL

HALAVEN, ERIBULIN MESYLATE

HEXALEN, ALTRETAMINE

LENVIMA, LENVATINIB MESYLATE

PANRETIN, ALITRETINOIN

SALAGEN, PILOCARPINE HYDROCHLORIDE

ZONEGRAN, ZONISAMIDE

ELAN PHARMA INTL LTD

* ELAN PHARMA INTERNATIONAL LTD

CLINDESSE, CLINDAMYCIN PHOSPHATE

EVAMIST, ESTRADIOL

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

ELI LILLY AND CO

* ELI LILLY AND CO

B - 49

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ELI LILLY AND CO

AXIRON, TESTOSTERONE

BASAGLAR, INSULIN GLARGINE

EFFIENT, PRASUGREL HYDROCHLORIDE

HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT

PROZAC, FLUOXETINE HYDROCHLORIDE

ELI LILLY CO

* ELI LILLY CO

ADCIRCA, TADALAFIL

ZYPREXA RELPREVV, OLANZAPINE PAMOATE

ELITE LABS

* ELITE LABORATORIES INC

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

ELITE LABS INC

* ELITE LABORATORIES INC

DANTROLENE SODIUM, DANTROLENE SODIUM

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

ISRADIPINE, ISRADIPINE

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

EMCURE PHARMS

* EMCURE PHARMACEUTICALS LTD

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

EMCURE PHARMS INDIA

* EMCURE PHARMACEUTICALS LTD INDIA

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

EMCURE PHARMS LTD

* EMCURE PHARMACEUTICALS LTD

ACARBOSE, ACARBOSE

ACETAZOLAMIDE SODIUM , ACETAZOLAMIDE SODIUM

ADENOSINE, ADENOSINE

AMIKACIN SULFATE, AMIKACIN SULFATE

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BICNU, CARMUSTINE

CIDOFOVIR, CIDOFOVIR

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

ETOMIDATE, ETOMIDATE

FUROSEMIDE, FUROSEMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

RIFAMPIN, RIFAMPIN

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

TRANEXAMIC ACID, TRANEXAMIC ACID

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

EMCURE PHARMS USA

* EMCURE PHARMACEUTICALS USA INC

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

EMD SERONO

* EMD SERONO INC

GONAL-F RFF REDI-JECT, FOLLITROPIN ALFA/BETA

GONAL-F RFF, FOLLITROPIN ALFA/BETA

GONAL-F, FOLLITROPIN ALFA/BETA

OVIDREL, CHORIOGONADOTROPIN ALFA

SAIZEN, SOMATROPIN RECOMBINANT

SEROSTIM, SOMATROPIN RECOMBINANT

ZORBTIVE, SOMATROPIN RECOMBINANT

EMD SERONO INC

B - 50

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* EMD SERONO INC

CETROTIDE, CETRORELIX

EMMAUS MEDCL

* EMMAUS MEDICAL INC

NUTRESTORE, GLUTAMINE

ENDO PHARM

* ENDO PHARMACEUTICAL SOLUTIONS INC

SUPPRELIN LA, HISTRELIN ACETATE

VALSTAR PRESERVATIVE FREE, VALRUBICIN

VANTAS, HISTRELIN ACETATE

ENDO PHARMS

* ENDO PHARMACEUTICALS INC

DELATESTRYL, TESTOSTERONE ENANTHATE

FORTESTA, TESTOSTERONE

FROVA, FROVATRIPTAN SUCCINATE

OPANA ER, OXYMORPHONE HYDROCHLORIDE

OPANA, OXYMORPHONE HYDROCHLORIDE

PERCODAN, ASPIRIN

ENDO PHARMS INC

* ENDO PHARMACEUTICALS INC

AVEED, TESTOSTERONE UNDECANOATE

BELBUCA, BUPRENORPHINE HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

ENDO VENTURES LTD

* ENDO VENTURES LTD

NATESTO, TESTOSTERONE

* ENDO VENTURES LTD IRELAND

SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE

EPIC PHARMA

* EPIC PHARMA INC

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

* EPIC PHARMA LLC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

SULINDAC, SULINDAC

TRANDOLAPRIL, TRANDOLAPRIL

URSODIOL, URSODIOL

EPIC PHARMA INC

* EPIC PHARMA INC

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

EPIC PHARMA LLC

* EPIC PHARMA LLC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

ERGOJECT

* ERGOJECT LLC

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

ESSENTIAL ISOTOPES

* ESSENTIAL ISOTOPES LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

ETHYPHARM

* ETHYPHARM

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

ETHYPHARM USA CORP

B - 51

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 52

PRODUCT NAME SORTED BY APPLICANT

**

**

* ETHYPHARM USA CORP

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

EUROHLTH INTL SARL

* EUROHEALTH INTERNATIONAL SARL

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ADENOSINE, ADENOSINE

ALLOPURINOL SODIUM, ALLOPURINOL SODIUM

ALPROSTADIL, ALPROSTADIL

AMIKACIN SULFATE, AMIKACIN SULFATE

AMRINONE LACTATE, INAMRINONE LACTATE

ATIVAN, LORAZEPAM

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM

AZTREONAM, AZTREONAM

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BUMETANIDE, BUMETANIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CAFCIT, CAFFEINE CITRATE

CARBOPLATIN, CARBOPLATIN

CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CISPLATIN, CISPLATIN

CLADRIBINE, CLADRIBINE

CYCLOSPORINE, CYCLOSPORINE

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DACTINOMYCIN, DACTINOMYCIN

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE

DIGOXIN, DIGOXIN

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOPRAM, DOXAPRAM HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE HYCLATE

DURAMORPH PF, MORPHINE SULFATE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ETOPOSIDE, ETOPOSIDE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FLOXURIDINE, FLOXURIDINE

FLUMAZENIL, FLUMAZENIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM, HEPARIN SODIUM

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

INFUMORPH, MORPHINE SULFATE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* EUROHEALTH INTERNATIONAL SARL

LEVOCARNITINE, LEVOCARNITINE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MESNA, MESNA

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALOXONE, NALOXONE HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXYTOCIN, OXYTOCIN

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PENTOSTATIN, PENTOSTATIN

PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE

PHENYTOIN SODIUM, PHENYTOIN SODIUM

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ROBAXIN, METHOCARBAMOL

ROBINUL, GLYCOPYRROLATE

SODIUM CHLORIDE 0.9% , SODIUM CHLORIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

SUFENTANIL CITRATE, SUFENTANIL CITRATE

THIOTEPA, THIOTEPA

VINBLASTINE SULFATE, VINBLASTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

EXALENZ BIOSCIENCE

* EXALENZ BIOSCIENCE LTD

IDKIT:HP, CITRIC ACID

EXELA PHARMA SCIENCE

* EXELA PHARMA SCIENCES

CAFFEINE CITRATE, CAFFEINE CITRATE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

EXELA PHARMA SCS LLC

* EXELA PHARMA SCIENCES LLC

CAFFEINE CITRATE, CAFFEINE CITRATE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

POTASSIUM ACETATE, POTASSIUM ACETATE

EXELIXIS

* EXELIXIS INC

COMETRIQ, CABOZANTINIB S-MALATE

FOUGERA

* E FOUGERA DIV ALTANA INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDROCORTISONE, HYDROCORTISONE

LIDOCAINE, LIDOCAINE

B - 53

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* E FOUGERA DIV ALTANA INC

NITROGLYCERIN, NITROGLYCERIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

LILLY

* ELI LILLY AND CO

ALIMTA, PEMETREXED DISODIUM

CIALIS, TADALAFIL

CYMBALTA, DULOXETINE HYDROCHLORIDE

EVISTA, RALOXIFENE HYDROCHLORIDE

FORTEO, TERIPARATIDE RECOMBINANT HUMAN

GEMZAR, GEMCITABINE HYDROCHLORIDE

GLUCAGON, GLUCAGON RECOMBINANT

HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT

HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG, INSULIN LISPRO RECOMBINANT

HUMATROPE, SOMATROPIN RECOMBINANT

HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN

(OTC)

HUMULIN 70/30, INSULIN RECOMBINANT HUMAN

(OTC)

HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

(OTC)

HUMULIN R PEN, INSULIN RECOMBINANT HUMAN

(OTC)

HUMULIN R, INSULIN RECOMBINANT HUMAN

HUMULIN R, INSULIN RECOMBINANT HUMAN

(OTC)

PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

STRATTERA, ATOMOXETINE HYDROCHLORIDE

SYMBYAX, FLUOXETINE HYDROCHLORIDE

ZYPREXA ZYDIS, OLANZAPINE

ZYPREXA, OLANZAPINE

**

**

FACTA FARMA

* FACTA FARMACEUTICI SPA

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

FALCON PHARMS

* FALCON PHARMACEUTICALS LTD

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

FDC LTD

* FDC LTD

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

OFLOXACIN, OFLOXACIN

TIMOLOL MALEATE, TIMOLOL MALEATE

FEINSTEIN

* FEINSTEIN INSTITUTE MEDICAL RESEARCH

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

FERA PHARMS

* FERA PHARMACEUTICALS LLC

OFLOXACIN, OFLOXACIN

TOBRAMYCIN, TOBRAMYCIN

FERA PHARMS LLC

* FERA PHARMACEUTICALS LLC

DAPSONE, DAPSONE

FERNDALE LABS

* FERNDALE LABORATORIES INC

HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE

FERNDALE LABS INC

* FERNDALE LABORATORIES INC

ULTRAVATE, HALOBETASOL PROPIONATE

B - 54

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

FERRING

* FERRING PHARMACEUTICALS INC

ACTHREL, CORTICORELIN OVINE TRIFLUTATE

BRAVELLE, UROFOLLITROPIN

CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

ENDOMETRIN, PROGESTERONE

FIRMAGON, DEGARELIX ACETATE

MENOPUR, MENOTROPINS (FSH

MINIRIN, DESMOPRESSIN ACETATE

ZOMACTON, SOMATROPIN RECOMBINANT

FERRING CONTROLLED

* FERRING CONTROLLED THERAPEUTICS LTD

CERVIDIL, DINOPROSTONE

FERRING PHARMS AS

* FERRING PHARMACEUTICALS AS

LYSTEDA, TRANEXAMIC ACID

PREPOPIK, CITRIC ACID

FERRING PHARMS INC

* FERRING PHARMACEUTICALS INC

DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DDAVP, DESMOPRESSIN ACETATE

FOREST LABS

* FOREST LABORATORIES INC

BYSTOLIC, NEBIVOLOL HYDROCHLORIDE

CAMPRAL, ACAMPROSATE CALCIUM

CELEXA, CITALOPRAM HYDROBROMIDE

LEXAPRO, ESCITALOPRAM OXALATE

THYROLAR-0.25, LIOTRIX (T4

THYROLAR-0.5, LIOTRIX (T4

THYROLAR-1, LIOTRIX (T4

THYROLAR-2, LIOTRIX (T4

THYROLAR-3, LIOTRIX (T4

FOREST LABS INC

* FOREST LABORATORIES INC

BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE

BENTYL, DICYCLOMINE HYDROCHLORIDE

CARAFATE, SUCRALFATE

FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE

RECTIV, NITROGLYCERIN

ULTRESA, PANCRELIPASE (AMYLASE

URSO 250, URSODIOL

URSO FORTE, URSODIOL

VIOKACE, PANCRELIPASE (AMYLASE

ZENPEP, PANCRELIPASE (AMYLASE

FOREST LABS LLC

* FOREST LABORATORIES LLC

CANASA, MESALAMINE

LINZESS, LINACLOTIDE

NAMENDA XR, MEMANTINE HYDROCHLORIDE

NAMENDA, MEMANTINE HYDROCHLORIDE

NAMZARIC, DONEPEZIL HYDROCHLORIDE

PYLERA, BISMUTH SUBCITRATE POTASSIUM

SAPHRIS, ASENAPINE MALEATE

VIIBRYD, VILAZODONE HYDROCHLORIDE

FOREST RES INST INC

* FOREST RESEARCH INSTITUTE INC

VRAYLAR, CARIPRAZINE HYDROCHLORIDE

FOREST TOSARA LTD

* FOREST TOSARA LTD

VIBERZI, ELUXADOLINE

FOUGERA PHARMS

* FOUGERA PHARMACEUTICALS INC

ADAPALENE, ADAPALENE

B - 55

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* FOUGERA PHARMACEUTICALS INC

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

AMCINONIDE, AMCINONIDE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

C-SOLVE-2, ERYTHROMYCIN

CALCIPOTRIENE, CALCIPOTRIENE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

CUTIVATE, FLUTICASONE PROPIONATE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE, HYDROCORTISONE

IMIQUIMOD, IMIQUIMOD

KETOCONAZOLE, KETOCONAZOLE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

METRONIDAZOLE, METRONIDAZOLE

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN, NYSTATIN

OXISTAT, OXICONAZOLE NITRATE

PANDEL, HYDROCORTISONE PROBUTATE

PREDNICARBATE, PREDNICARBATE

SOLARAZE, DICLOFENAC SODIUM

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TEMOVATE, CLOBETASOL PROPIONATE

TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

FOUGERA PHARMS INC

* FOUGERA PHARMACEUTICALS INC

FLUOCINONIDE, FLUOCINONIDE

TACROLIMUS, TACROLIMUS

FRESENIUS

* FRESENIUS KABI DEUTSCHLAND GMBH

INTRALIPID 10%, SOYBEAN OIL

INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL

FRESENIUS KABI

* FRESENIUS KABI AUSTRIA GMBH

LACTULOSE, LACTULOSE

FRESENIUS KABI ONCOL

* FRESENIUS KABI ONCOLOGY PLC

ANASTROZOLE, ANASTROZOLE

BICALUTAMIDE, BICALUTAMIDE

CARBOPLATIN, CARBOPLATIN

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LETROZOLE, LETROZOLE

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

FRESENIUS KABI USA

* FRESENIUS KABI USA LLC

ACETAMINOPHEN, ACETAMINOPHEN

B - 56

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* FRESENIUS KABI USA LLC

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

AMIKACIN SULFATE, AMIKACIN SULFATE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ARGATROBAN, ARGATROBAN

ASTRAMORPH PF, MORPHINE SULFATE

AZITHROMYCIN, AZITHROMYCIN

AZTREONAM, AZTREONAM

BACITRACIN, BACITRACIN

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

CAFFEINE CITRATE, CAFFEINE CITRATE

CARBOPLATIN, CARBOPLATIN

CEFOTETAN, CEFOTETAN DISODIUM

CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CISPLATIN, CISPLATIN

CLADRIBINE, CLADRIBINE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DIMENHYDRINATE, DIMENHYDRINATE

DIPRIVAN, PROPOFOL

DIPYRIDAMOLE, DIPYRIDAMOLE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXY 100, DOXYCYCLINE HYCLATE

DOXY 200, DOXYCYCLINE HYCLATE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ETOPOSIDE, ETOPOSIDE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLOXURIDINE, FLOXURIDINE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUMAZENIL, FLUMAZENIL

FLUOROURACIL, FLUOROURACIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GANCICLOVIR, GANCICLOVIR SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GLUCAGON, GLUCAGON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

B - 57

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* FRESENIUS KABI USA LLC

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

INDOMETHACIN, INDOMETHACIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

KANAMYCIN SULFATE, KANAMYCIN SULFATE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MANNITOL 25%, MANNITOL

MESNA, MESNA

METARAMINOL BITARTRATE, METARAMINOL BITARTRATE

METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NAROPIN, ROPIVACAINE HYDROCHLORIDE

NEBUPENT, PENTAMIDINE ISETHIONATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NESACAINE, CHLOROPROCAINE HYDROCHLORIDE

NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

OXYTOCIN, OXYTOCIN

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PENTAM, PENTAMIDINE ISETHIONATE

PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

POLOCAINE, MEPIVACAINE HYDROCHLORIDE

POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROGESTERONE, PROGESTERONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROTAMINE SULFATE, PROTAMINE SULFATE

PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

VALPROATE SODIUM, VALPROATE SODIUM

B - 58

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* FRESENIUS KABI USA LLC

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VIBISONE, CYANOCOBALAMIN

VINBLASTINE SULFATE, VINBLASTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE

XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

FRESENIUS MEDCL

* FRESENIUS MEDICAL CARE NORTH AMERICA

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOSLO GELCAPS, CALCIUM ACETATE

PHOSLYRA, CALCIUM ACETATE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

FSC

* FSC LABORATORIES INC

PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE

**

**

G AND W LABS

* G AND W LABORATORIES INC

ACEPHEN, ACETAMINOPHEN
(OTC)

CICLOPIROX, CICLOPIROX

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

INDOMETHACIN, INDOMETHACIN

METRONIDAZOLE, METRONIDAZOLE

MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE

(OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

PROCHLORPERAZINE, PROCHLORPERAZINE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

G AND W LABS INC

* G AND W LABORATORIES INC

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BETA-VAL, BETAMETHASONE VALERATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE, CALCIPOTRIENE

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

CICLOPIROX, CICLOPIROX

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

FLUOCINONIDE, FLUOCINONIDE

B - 59

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* G AND W LABORATORIES INC

IMIQUIMOD, IMIQUIMOD

MESALAMINE, MESALAMINE

METRONIDAZOLE, METRONIDAZOLE

MICONAZOLE NITRATE, MICONAZOLE NITRATE

(OTC)

MYKACET, NYSTATIN

NYSTATIN, NYSTATIN

PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE

PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE

QUINIDINE SULFATE, QUINIDINE SULFATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

GALDERMA LABS

* GALDERMA LABORATORIES INC

CLOBEX, CLOBETASOL PROPIONATE

EPIDUO FORTE, ADAPALENE

GALDERMA LABS LP

* GALDERMA LABORATORIES L P

CLOBEX, CLOBETASOL PROPIONATE

* GALDERMA LABORATORIES LP

CAPEX, FLUOCINOLONE ACETONIDE

CLOBEX, CLOBETASOL PROPIONATE

DESOWEN, DESONIDE

DIFFERIN, ADAPALENE

EPIDUO, ADAPALENE

METROCREAM, METRONIDAZOLE

METROGEL, METRONIDAZOLE

METROLOTION, METRONIDAZOLE

MIRVASO, BRIMONIDINE TARTRATE

ORACEA, DOXYCYCLINE

PLIAGLIS, LIDOCAINE

SOOLANTRA, IVERMECTIN

TRI-LUMA, FLUOCINOLONE ACETONIDE

VECTICAL, CALCITRIOL

GALEN (UK)

* GALEN LTD

DAUNOXOME, DAUNORUBICIN CITRATE

GALEN SPECIALTY

* GALEN SPECIALTY PHARMA US LLC

SYNERA, LIDOCAINE

GALENA BIOPHARMA INC

* GALENA BIOPHARMA INC

ZUPLENZ, ONDANSETRON

GASTROENTERO

* GASTROENTERO LOGIC LLC

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN

GATE PHARMS

* GATE PHARMACEUTICALS

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

GAVIS PHARMS

* GAVIS PHARMACEUTICALS LLC

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NYSTATIN, NYSTATIN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

QUINARETIC, HYDROCHLOROTHIAZIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

GAVIS PHARMS LLC

* GAVIS PHARMACEUTICALS LLC

CYANOCOBALAMIN, CYANOCOBALAMIN

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

GD SEARLE

* GD SEARLE LLC

CELEBREX, CELECOXIB

B - 60

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* GD SEARLE LLC

DAYPRO, OXAPROZIN

GD SEARLE LLC

* GD SEARLE LLC

ALDACTAZIDE, HYDROCHLOROTHIAZIDE

ALDACTONE, SPIRONOLACTONE

ARTHROTEC, DICLOFENAC SODIUM

CALAN, VERAPAMIL HYDROCHLORIDE

COVERA-HS, VERAPAMIL HYDROCHLORIDE

CYTOTEC, MISOPROSTOL

FLAGYL ER, METRONIDAZOLE

FLAGYL, METRONIDAZOLE

INSPRA, EPLERENONE

LOMOTIL, ATROPINE SULFATE

NORPACE CR, DISOPYRAMIDE PHOSPHATE

NORPACE, DISOPYRAMIDE PHOSPHATE

SYNAREL, NAFARELIN ACETATE

GE HEALTHCARE

* GE HEALTHCARE

ADREVIEW, IOBENGUANE SULFATE I-123

CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT

INDICLOR, INDIUM IN-111 CHLORIDE

INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE

METASTRON, STRONTIUM CHLORIDE SR-89

MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT

MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM

MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT

MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT

OMNIPAQUE 140, IOHEXOL

OMNIPAQUE 180, IOHEXOL

OMNIPAQUE 240, IOHEXOL

OMNIPAQUE 300, IOHEXOL

OMNIPAQUE 350, IOHEXOL

OMNISCAN, GADODIAMIDE

OPTISON, ALBUMIN HUMAN

TECHNETIUM TC 99M GENERATOR, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL

VIZAMYL, FLUTEMETAMOL F-18

GE HLTHCARE INC

* GE HEALTHCARE INC

DATSCAN, IOFLUPANE I-123

GEDEON RICHTER USA

* GEDEON RICHTER USA INC

FINASTERIDE, FINASTERIDE

GEMINI LABS LLC

* GEMINI LABORATORIES LLC

OXANDRIN, OXANDROLONE

GENENTECH

* GENENTECH INC

ERIVEDGE, VISMODEGIB

NUTROPIN AQ NUSPIN, SOMATROPIN RECOMBINANT

NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT

GENENTECH INC

* GENENTECH INC

COTELLIC, COBIMETINIB FUMARATE

ESBRIET, PIRFENIDONE

GENZYME

* GENZYME CORP

CEREZYME, IMIGLUCERASE

CLOLAR, CLOFARABINE

MOZOBIL, PLERIXAFOR

RENAGEL, SEVELAMER HYDROCHLORIDE

RENVELA, SEVELAMER CARBONATE

B - 61

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* GENZYME CORP

THYROGEN, THYROTROPIN ALFA

GENZYME CORP

* GENZYME CORP

CERDELGA, ELIGLUSTAT TARTRATE

HECTOROL, DOXERCALCIFEROL

KYNAMRO, MIPOMERSEN SODIUM

GILEAD

* GILEAD SCIENCES INC

ATRIPLA, EFAVIRENZ

CAYSTON, AZTREONAM

EMTRIVA, EMTRICITABINE

HEPSERA, ADEFOVIR DIPIVOXIL

LETAIRIS, AMBRISENTAN

RANEXA, RANOLAZINE

TRUVADA, EMTRICITABINE

GILEAD SCIENCES INC

* GILEAD SCIENCES INC

COMPLERA, EMTRICITABINE

GENVOYA, COBICISTAT

HARVONI, LEDIPASVIR

SOVALDI, SOFOSBUVIR

STRIBILD, COBICISTAT

TYBOST, COBICISTAT

VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VITEKTA, ELVITEGRAVIR

ZYDELIG, IDELALISIB

GLAND PHARMA LTD

* GLAND PHARMA LTD

ADENOSINE, ADENOSINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

GLAXO GRP ENGLAND

* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

INCRUSE ELLIPTA , UMECLIDINIUM BROMIDE

GLAXO GRP LTD

* GLAXO GROUP LTD DBA GLAXOSMITHKLINE

ALTABAX, RETAPAMULIN

FLOVENT HFA, FLUTICASONE PROPIONATE

* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE

ADVAIR HFA, FLUTICASONE PROPIONATE

BREO ELLIPTA, FLUTICASONE FUROATE

FLOVENT DISKUS 100, FLUTICASONE PROPIONATE

FLOVENT DISKUS 250, FLUTICASONE PROPIONATE

FLOVENT DISKUS 50, FLUTICASONE PROPIONATE

ZANTAC 150, RANITIDINE HYDROCHLORIDE

ZANTAC 300, RANITIDINE HYDROCHLORIDE

ZANTAC, RANITIDINE HYDROCHLORIDE

GLAXOSMITHKLINE

* GLAXOSMITHKLINE

ABREVA, DOCOSANOL
(OTC)

ALKERAN, MELPHALAN

ALKERAN, MELPHALAN HYDROCHLORIDE

AVODART, DUTASTERIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* GLAXOSMITHKLINE

BACTROBAN, MUPIROCIN

BACTROBAN, MUPIROCIN CALCIUM

BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE

CEFTIN, CEFUROXIME AXETIL

EPIVIR-HBV, LAMIVUDINE

FLONASE, FLUTICASONE PROPIONATE

IMITREX STATDOSE, SUMATRIPTAN SUCCINATE

IMITREX, SUMATRIPTAN

IMITREX, SUMATRIPTAN SUCCINATE

JALYN, DUTASTERIDE

MALARONE PEDIATRIC, ATOVAQUONE

MALARONE, ATOVAQUONE

NICORETTE (MINT), NICOTINE POLACRILEX

(OTC)

NICORETTE, NICOTINE POLACRILEX

(OTC)

POTIGA, EZOGABINE

RELENZA, ZANAMIVIR

VALTREX, VALACYCLOVIR HYDROCHLORIDE

VERAMYST, FLUTICASONE FUROATE

WELLBUTRIN SR, BUPROPION HYDROCHLORIDE

WELLBUTRIN, BUPROPION HYDROCHLORIDE

ZYBAN, BUPROPION HYDROCHLORIDE

* GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND

ANORO ELLIPTA, UMECLIDINIUM BROMIDE

ARNUITY ELLIPTA, FLUTICASONE FUROATE

* GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND

SEREVENT, SALMETEROL XINAFOATE

VENTOLIN HFA, ALBUTEROL SULFATE

GLAXOSMITHKLINE CONS

* GLAXOSMITHKLINE CONSUMER HEALTHCARE

ALLI, ORLISTAT
(OTC)

COMMIT, NICOTINE POLACRILEX

(OTC)

FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE

(OTC)

NICORETTE, NICOTINE POLACRILEX

(OTC)

VOLTAREN, DICLOFENAC SODIUM

GLAXOSMITHKLINE LLC

* GLAXOSMITHKLINE LLC

AMERGE, NARATRIPTAN HYDROCHLORIDE

DYAZIDE, HYDROCHLOROTHIAZIDE

FLOLAN, EPOPROSTENOL SODIUM

INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE

LAMICTAL CD, LAMOTRIGINE

LAMICTAL ODT, LAMOTRIGINE

LAMICTAL XR, LAMOTRIGINE

LAMICTAL, LAMOTRIGINE

MEPRON, ATOVAQUONE

REQUIP XL, ROPINIROLE HYDROCHLORIDE

REQUIP, ROPINIROLE HYDROCHLORIDE

RYTHMOL SR, PROPAFENONE HYDROCHLORIDE

RYTHMOL, PROPAFENONE HYDROCHLORIDE

GLENMARK GENERICS

* GLENMARK GENERICS INC USA

ADAPALENE, ADAPALENE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE, CALCIPOTRIENE

IMIQUIMOD, IMIQUIMOD

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN CALCIUM

NIZATIDINE, NIZATIDINE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

* GLENMARK GENERICS LIMITED

BRIELLYN, ETHINYL ESTRADIOL

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

B - 63

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* GLENMARK GENERICS LTD

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

ALYACEN 1/35, ETHINYL ESTRADIOL

ALYACEN 7/7/7, ETHINYL ESTRADIOL

ASHLYNA, ETHINYL ESTRADIOL

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE

CARVEDILOL, CARVEDILOL

CICLOPIROX, CICLOPIROX

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DESOXIMETASONE, DESOXIMETASONE

ESZOPICLONE, ESZOPICLONE

FELODIPINE, FELODIPINE

FLUCONAZOLE, FLUCONAZOLE

FLUOCINONIDE, FLUOCINONIDE

GABAPENTIN, GABAPENTIN

HEATHER, NORETHINDRONE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

LAMOTRIGINE, LAMOTRIGINE

LEVOFLOXACIN, LEVOFLOXACIN

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LITHIUM CARBONATE, LITHIUM CARBONATE

MARLISSA, ETHINYL ESTRADIOL

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MOMETASONE FUROATE, MOMETASONE FUROATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN, NAPROXEN

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RILUZOLE, RILUZOLE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TELMISARTAN, TELMISARTAN

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

TOPIRAMATE, TOPIRAMATE

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

URSODIOL, URSODIOL

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VIORELE, DESOGESTREL

ZOLMITRIPTAN, ZOLMITRIPTAN

* GLENMARK GENERICS LTD INDIA

INDOMETHACIN, INDOMETHACIN

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

GLENMARK PHARMS

* GLENMARK PHARMACEUTICALS INC USA

CICLOPIROX, CICLOPIROX

CLOTRIMAZOLE, CLOTRIMAZOLE

MUPIROCIN, MUPIROCIN

* GLENMARK PHARMACEUTICALS LTD

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

GLENMARK PHARMS INC

* GLENMARK PHARMACEUTICALS INC USA

B - 64

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* GLENMARK PHARMACEUTICALS INC USA

LITHIUM CARBONATE, LITHIUM CARBONATE

GLENMARK PHARMS LTD

* GLENMARK PHARMACEUTICALS LTD

CALCIPOTRIENE, CALCIPOTRIENE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LINEZOLID, LINEZOLID

VORICONAZOLE, VORICONAZOLE

GLOBAL ISOTOPES LLC

* GLOBAL ISOTOPES LLC DBA ZEVACOR MOLECULAR

AMMONIA N 13, AMMONIA N-13

CHOLINE C-11, CHOLINE C-11

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

GRANULES INDIA

* GRANULES INDIA LTD

IBUPROFEN, IBUPROFEN
(OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

GRANULES INDIA LTD

* GRANULES INDIA LTD

IBUPROFEN, IBUPROFEN

GUARDIAN DRUG

* GUARDIAN DRUG CO INC

FOAMCOAT, ALUMINUM HYDROXIDE

(OTC)

GUERBET

* GUERBET LLC

DOTAREM, GADOTERATE MEGLUMINE

LIPIODOL, ETHIODIZED OIL

OXILAN-300, IOXILAN

OXILAN-350, IOXILAN

HANFORD GC

* GC HANFORD MANUFACTURING CO

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

**

**

HAEMONETICS

* HAEMONETICS CORP

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

HALOCARBON PRODS

* HALOCARBON PRODUCTS CORP

ISOFLURANE, ISOFLURANE

SEVOFLURANE, SEVOFLURANE

HALOZYME THERAP

* HALOZYME THERAPEUTICS INC

HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN

HAMELN RDS GMBH

* HAMELN RDS GMBH

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HANMI PHARM CO LTD

* HANMI PHARMACEUTICAL CO LTD

ESOMEPRAZOLE STRONTIUM, ESOMEPRAZOLE STRONTIUM

HARRIS PHARM

* HARRIS PHARMACEUTICAL INC

FLUCONAZOLE, FLUCONAZOLE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

HAUPT PHARMA

* HAUPT PHARMA INC

B - 65

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* HAUPT PHARMA INC

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

HEC PHARM USA INC

* HEC PHARM USA INC

CLARITHROMYCIN, CLARITHROMYCIN

HELSINN HLTHCARE

* HELSINN HEALTHCARE SA

AKYNZEO, NETUPITANT

ALOXI, PALONOSETRON HYDROCHLORIDE

HERCON PHARM

* HERCON PHARMACEUTICAL LLC

NITROGLYCERIN, NITROGLYCERIN

HERITAGE LIFE

* HERITAGE LIFE SCIENCES BARBADOS INC

CLOZARIL, CLOZAPINE

HERITAGE PHARMA

* HERITAGE PHARMA LABS INC

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

DIFLUNISAL, DIFLUNISAL

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

METHIMAZOLE, METHIMAZOLE

NIFEDIPINE, NIFEDIPINE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

HERITAGE PHARMS INC

* HERITAGE PHARMACEUTICALS INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

CALCIUM ACETATE, CALCIUM ACETATE

CARISOPRODOL AND ASPIRIN, ASPIRIN

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

ETHOSUXIMIDE, ETHOSUXIMIDE

FELODIPINE, FELODIPINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

LEFLUNOMIDE, LEFLUNOMIDE

MOEXIPRIL HYDROCHLORIDE AND HYDROCHOLROTHIAZIDE, HYDROCHLOROTHIAZIDE

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NYSTATIN, NYSTATIN

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

SULINDAC, SULINDAC

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

HETERO LABS LTD III

* HETERO LABS LTD UNIT III

ABACAVIR SULFATE, ABACAVIR SULFATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FINASTERIDE, FINASTERIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LEVETIRACETAM, LEVETIRACETAM

B - 66

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* HETERO LABS LTD UNIT III

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

METHOCARBAMOL, METHOCARBAMOL

NEVIRAPINE, NEVIRAPINE

SIMVASTATIN, SIMVASTATIN

STAVUDINE, STAVUDINE

TORSEMIDE, TORSEMIDE

ZIDOVUDINE, ZIDOVUDINE

HETERO LABS LTD V

* HETERO LABS LTD UNIT V

ACYCLOVIR, ACYCLOVIR

ARIPIPRAZOLE, ARIPIPRAZOLE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ENTECAVIR, ENTECAVIR

FAMCICLOVIR, FAMCICLOVIR

IRBESARTAN, IRBESARTAN

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LEVOFLOXACIN, LEVOFLOXACIN

LINEZOLID, LINEZOLID

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MONTELUKAST SODIUM, MONTELUKAST SODIUM

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALSARTAN, VALSARTAN

HEYL CHEMISCH

* HEYL CHEMISCH PHARMAZEUTISHE FABRIK

RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)

HI TECH PHARMA

* HI TECH PHARMACAL CO INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

CALCIPOTRIENE, CALCIPOTRIENE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CICLOPIROX, CICLOPIROX

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CORMAX, CLOBETASOL PROPIONATE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

EMBELINE E, CLOBETASOL PROPIONATE

EMBELINE, CLOBETASOL PROPIONATE

ERYTHRO-STATIN, ERYTHROMYCIN

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GABAPENTIN, GABAPENTIN

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LACTULOSE, LACTULOSE

LEVOCARNITINE, LEVOCARNITINE

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE AND PRILOCAINE, LIDOCAINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL

(OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL

(OTC)

NYSTATIN, NYSTATIN

OFLOXACIN, OFLOXACIN

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

B - 67

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 68

PRODUCT NAME SORTED BY APPLICANT

**

**

* HI TECH PHARMACAL CO INC

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TIMOLOL MALEATE, TIMOLOL MALEATE

VOSOL HC, ACETIC ACID, GLACIAL

VOSOL, ACETIC ACID, GLACIAL

HI TECH PHARMA CO

* HI TECH PHARMACAL CO INC

FLUNISOLIDE, FLUNISOLIDE

PREDNISOLONE, PREDNISOLONE

HI-TECH PHARMA CO

* HI-TECH PHARMACAL CO INC

FAMOTIDINE, FAMOTIDINE

GATIFLOXACIN, GATIFLOXACIN

LORAZEPAM, LORAZEPAM

PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE,

HI-TECH PHARMACAL

* HI-TECH PHARMACAL CO INC

BROMFENAC SODIUM, BROMFENAC SODIUM

LEVETIRACETAM, LEVETIRACETAM

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE

HIGH TECH PHARMA

* HIGH TECHNOLOGY PHARMACAL CO INC

VALPROIC ACID, VALPROIC ACID

HIKMA

* HIKMA FARMACEUTICA LDA

CEFOTAXIME, CEFOTAXIME SODIUM

* HIKMA PHARMACEUTICALS

AMOXICILLIN, AMOXICILLIN

CEFACLOR, CEFACLOR

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEPHALEXIN, CEPHALEXIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GLYBURIDE (MICRONIZED), GLYBURIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

HIKMA FARMACEUTICA

* HIKMA FARMACEUTICA (PORTUGAL) SA

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CEFOXITIN, CEFOXITIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUMAZENIL, FLUMAZENIL

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE

MILRINONE LACTATE, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROGESTERONE, PROGESTERONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

CODEINE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* HIKMA FARMACEUTICA (PORTUGAL) SA

VALPROATE SODIUM, VALPROATE SODIUM

* HIKMA FARMACEUTICA PORTUGAL LDA

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

* HIKMA FARMACEUTICA PORTUGAL SA

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

OXYTOCIN, OXYTOCIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

* HIKMA FARMACEUTICA SA

ZOLEDRONIC ACID, ZOLEDRONIC ACID

HIKMA INTL PHARMS

* HIKMA INTERNATIONAL PHARMACEUTICALS LLC

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CORTISONE ACETATE, CORTISONE ACETATE

DIGOXIN, DIGOXIN

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

HYDROCORTISONE, HYDROCORTISONE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LITHIUM CARBONATE, LITHIUM CARBONATE

METHOCARBAMOL, METHOCARBAMOL

MITIGARE, COLCHICINE

NAPROXEN, NAPROXEN

HIKMA MAPLE

* HIKMA MAPLE LTD

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

CEFOXITIN, CEFOXITIN SODIUM

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MITOMYCIN, MITOMYCIN

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

HIKMA PHARM CO LTD

* HIKMA PHARM CO LTD

ARGATROBAN, ARGATROBAN

HIKMA PHARMS

* HIKMA PHARMACEUTICALS

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

GEMFIBROZIL, GEMFIBROZIL

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

MODAFINIL, MODAFINIL

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

* HIKMA PHARMACEUTICALS CO LTD

PARICALCITOL, PARICALCITOL

* HIKMA PHARMACEUTICALS LLC

PREDNISONE, PREDNISONE

HIKMA PHARMS LLC

* HIKMA PHARMACEUTICALS LLC

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

B - 69

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* HIKMA PHARMACEUTICALS LLC

CAPTOPRIL, CAPTOPRIL

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

DOXERCALCIFEROL, DOXERCALCIFEROL

FOLIC ACID, FOLIC ACID

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

PRIMIDONE, PRIMIDONE

ZALEPLON, ZALEPLON

HILL DERMAC

* HILL DERMACEUTICALS INC

DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

DERMOTIC, FLUOCINOLONE ACETONIDE

HILL DERMACEUTICALS

* HILL DERMACEUTICALS INC

TOLAK, FLUOROURACIL

HISAMITSU PHARM CO

* HISAMITSU PHARMACEUTICAL CO INC

SALONPAS, MENTHOL
(OTC)

HISUN PHARM HANGZHOU

* HISUN PHARMACEUTICAL (HANGZHOU) CO LTD

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

HOFFMANN LA ROCHE

* HOFFMANN LA ROCHE INC

ANAPROX DS, NAPROXEN SODIUM

ANAPROX, NAPROXEN SODIUM

BONIVA, IBANDRONATE SODIUM

INVIRASE, SAQUINAVIR MESYLATE

ROCEPHIN, CEFTRIAXONE SODIUM

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE

XELODA, CAPECITABINE

XENICAL, ORLISTAT

ZELBORAF, VEMURAFENIB

HOFFMANN-LA ROCHE

* HOFFMANN-LA ROCHE INC

ALECENSA, ALECTINIB HYDROCHLORIDE

INVIRASE, SAQUINAVIR MESYLATE

HOPE PHARMS

* HOPE PHARMACEUTICALS

NITHIODOTE, SODIUM NITRITE

SODIUM NITRITE, SODIUM NITRITE

SODIUM THIOSULFATE, SODIUM THIOSULFATE

HORIZON PHARMA

* HORIZON PHARMA INC

DUEXIS, FAMOTIDINE

RAYOS, PREDNISONE

VIMOVO, ESOMEPRAZOLE MAGNESIUM

* HORIZON PHARMA IRELAND LTD

PENNSAID, DICLOFENAC SODIUM

HORIZON THERAPS INC

* HORIZON THERAPEUTICS INC

RAVICTI, GLYCEROL PHENYLBUTYRATE

HOSPIRA

* HOSPIRA INC

A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE

A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

ACETYLCYSTEINE, ACETYLCYSTEINE

ALFENTANIL, ALFENTANIL HYDROCHLORIDE

AMIDATE, ETOMIDATE

AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID

AMINOPHYLLINE, AMINOPHYLLINE

B - 70

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 71

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC

AMINOSYN 10% (PH6), AMINO ACIDS

AMINOSYN 10%, AMINO ACIDS

AMINOSYN 3.5% M, AMINO ACIDS

AMINOSYN 3.5%, AMINO ACIDS

AMINOSYN 5%, AMINO ACIDS

AMINOSYN 7% (PH6), AMINO ACIDS

AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN 7%, AMINO ACIDS

AMINOSYN 8.5% (PH6), AMINO ACIDS

AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN 8.5%, AMINO ACIDS

AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN II 10%, AMINO ACIDS

AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 7%, AMINO ACIDS

AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN II 8.5%, AMINO ACIDS

AMINOSYN-HBC 7%, AMINO ACIDS

AMINOSYN-HF 8%, AMINO ACIDS

AMINOSYN-PF 10%, AMINO ACIDS

AMINOSYN-PF 7%, AMINO ACIDS

AMINOSYN-RF 5.2%, AMINO ACIDS

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE

AQUASOL A, VITAMIN A PALMITATE

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE

ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE

AZITHROMYCIN, AZITHROMYCIN

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BUMETANIDE, BUMETANIDE

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CARBOCAINE, MEPIVACAINE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CORLOPAM, FENOLDOPAM MESYLATE

CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEMEROL, MEPERIDINE HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 25%, DEXTROSE

DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 72

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC

DEXTROSE 50% , DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DIAZEPAM, DIAZEPAM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DROPERIDOL, DROPERIDOL

ENALAPRILAT, ENALAPRILAT

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FENTANYL CITRATE, FENTANYL CITRATE

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FOSCARNET SODIUM, FOSCARNET SODIUM

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISOFLURANE, ISOFLURANE

ISUPREL, ISOPROTERENOL HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LEVOPHED, NOREPINEPHRINE BITARTRATE

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

LTA II KIT, LIDOCAINE HYDROCHLORIDE

M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID

M.V.I. ADULT, ASCORBIC ACID

M.V.I. PEDIATRIC, ASCORBIC ACID

M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE

MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 73

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC

MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 25%, MANNITOL

MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

MARCAINE, BUPIVACAINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

MORPHINE SULFATE, MORPHINE SULFATE

NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE

POTASSIUM ACETATE, POTASSIUM ACETATE

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 74

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

PROPOFOL, PROPOFOL

QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE

QUELICIN, SUCCINYLCHOLINE CHLORIDE

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS

SODIUM BICARBONATE, SODIUM BICARBONATE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE

SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

SUFENTANIL CITRATE, SUFENTANIL CITRATE

TALWIN, PENTAZOCINE LACTATE

TAZICEF, CEFTAZIDIME

THAM, TROMETHAMINE

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

VITAMIN K1, PHYTONADIONE

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE

* HOSPIRA WORLDWIDE, INC

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

NITROPRESS, SODIUM NITROPRUSSIDE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

HOSPIRA INC

* HOSPIRA INC

A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE

ADENOSINE, ADENOSINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

BIVALIRUDIN, BIVALIRUDIN

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFOXITIN, CEFOXITIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

DAPTOMYCIN, DAPTOMYCIN

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC

DOCETAXEL, DOCETAXEL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HEPARIN SODIUM, HEPARIN SODIUM

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IMIPENEM AND CILASTATIN, CILASTATIN SODIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOFLOXACIN, LEVOFLOXACIN

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, LINEZOLID

LINEZOLID, LINEZOLID

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MAXIPIME, CEFEPIME HYDROCHLORIDE

MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

MEROPENEM, MEROPENEM

MILRINONE LACTATE, MILRINONE LACTATE

MORPHINE SULFATE, MORPHINE SULFATE

NIPENT, PENTOSTATIN

OXACILLIN SODIUM, OXACILLIN SODIUM

OXALIPLATIN, OXALIPLATIN

PARICALCITOL, PARICALCITOL

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

HOSPIRA WORLDWIDE

* HOSPIRA WORLDWIDE PTY

OXALIPLATIN, OXALIPLATIN

HOT SHOTS NM LLC

* HOT SHOTS NUCLEAR MEDICINE LLC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

HOUSTON CYCLOTRON

* HOUSTON CYCLOTRON PARTNERS LP

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

HQ SPCLT PHARMA

* HQ SPECIALTY PHARMA CORP

CISPLATIN, CISPLATIN

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

TAXOL, PACLITAXEL

HQ SPECIALITY PHARMA

* HQ SPECIALITY PHARMA LLC

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

HQ SPECLT PHARMA

* HQ SPECIALTY PHARMA

VUMON, TENIPOSIDE

HRA PHARMA

* HRA PHARMA LLC

METOPIRONE, METYRAPONE

HYPERION THERAPS INC

* HYPERION THERAPEUTICS INC

BUPHENYL, SODIUM PHENYLBUTYRATE

ROCHE

* HOFFMANN LA ROCHE INC

BONIVA, IBANDRONATE SODIUM

COPEGUS, RIBAVIRIN

FUZEON, ENFUVIRTIDE

KLONOPIN, CLONAZEPAM

TAMIFLU, OSELTAMIVIR PHOSPHATE

VALIUM, DIAZEPAM

**

**

B - 75

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

IBA MOLECULAR N AM

* IBA MOLECULAR NORTH AMERICA INC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

IDENTI PHARMS INC

* IDENTI PHARMACEUTICALS INC

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

IDT

* INSPIRION DELIVERY TECHNOLOGIES LLC

MORPHABOND, MORPHINE SULFATE

IGI LABS INC

* IGI LABORATORIES INC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ECONAZOLE NITRATE, ECONAZOLE NITRATE

FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM

FORTAZ, CEFTAZIDIME

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

IMPAX LABS

* IMPAX LABORATORIES INC

ACARBOSE, ACARBOSE

ALPRAZOLAM, ALPRAZOLAM

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE

DANTROLENE SODIUM, DANTROLENE SODIUM

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DIGOXIN, DIGOXIN

DIPYRIDAMOLE, DIPYRIDAMOLE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE

(OTC)

LORATADINE, LORATADINE
(OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE

OMEPRAZOLE, OMEPRAZOLE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PENTOXIFYLLINE, PENTOXIFYLLINE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RILUZOLE, RILUZOLE

RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

IMPAX LABS INC

* IMPAX LABORATORIES INC

CABERGOLINE, CABERGOLINE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

B - 76

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* IMPAX LABORATORIES INC

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RYTARY, CARBIDOPA

URSODIOL, URSODIOL

IMPAX PHARMS

* IMPAX PHARMACEUTICALS

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

GEMFIBROZIL, GEMFIBROZIL

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

INCYTE CORP

* INCYTE CORP

JAKAFI, RUXOLITINIB PHOSPHATE

INDICUS PHARMA

* INDICUS PHARMA LLC

CARISOPRODOL, CARISOPRODOL

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LETROZOLE, LETROZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PERPHENAZINE, PERPHENAZINE

INDIVIOR INC

* INDIVIOR INC

BUPRENEX, BUPRENORPHINE HYDROCHLORIDE

SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

INDOCO REMEDIES

* INDOCO REMEDIES LTD

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

GLIMEPIRIDE, GLIMEPIRIDE

INJECTALIA

* INJECTALIA SRL

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

INNOCUTIS HOLDINGS

* INNOCUTIS HOLDINGS LLC

SITAVIG, ACYCLOVIR

INNOPHARMA LICENSING

* INNOPHARMA LICENSING LLC

ACETYLCYSTEINE, ACETYLCYSTEINE

INO

* INO THERAPEUTICS INC

INOMAX, NITRIC OXIDE

INST BIOCHEM

* INSTITUT BIOCHEMIQUE SA

FLECTOR, DICLOFENAC EPOLAMINE

INST BIOCHIMIQUE

* INSTITUTE BIOCHIMIQUE SA (IBSA)

TIROSINT, LEVOTHYROXINE SODIUM

INSTITUT BIOCHIMIQUE

* INSTITUT BIOCHIMIQUE SA IBSA

TIROSINT, LEVOTHYROXINE SODIUM

INSYS THERAP

* INSYS THERAPEUTICS INC

SUBSYS, FENTANYL

INTELLIPHARMACEUTICS

* INTELLIPHARMACEUTICS CORP

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

INTERGEL PHARM

* INTERGEL PHARMACEUTICAL INC

B - 77

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* INTERGEL PHARMACEUTICAL INC

NIFEDIPINE, NIFEDIPINE

INTERPHARMA PRAHA AS

* INTERPHARMA PRAHA AS

ORALTAG, IOHEXOL

INTL MEDICATED

* INTERNATIONAL MEDICATED SYSTEMS LTD

MILRINONE LACTATE, MILRINONE LACTATE

INTL MEDICATION

* INTERNATIONAL MEDICATION SYSTEM

LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MANNITOL 25%, MANNITOL

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

PHYTONADIONE, PHYTONADIONE

* INTERNATIONAL MEDICATION SYSTEMS LTD

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

INTL MEDICATION SYS

* INTERNATIONAL MEDICATION SYSTEMS LTD

LORAZEPAM, LORAZEPAM

INVAGEN PHARMS

* INVAGEN PHARMACEUTICALS INC

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CALCIUM ACETATE, CALCIUM ACETATE

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FOLIC ACID, FOLIC ACID

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

GEMFIBROZIL, GEMFIBROZIL

GLIMEPIRIDE, GLIMEPIRIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL, LISINOPRIL

MEPROBAMATE, MEPROBAMATE

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

NAPROXEN, NAPROXEN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TRANDOLAPRIL, TRANDOLAPRIL

WARFARIN SODIUM, WARFARIN SODIUM

ZOLMITRIPTAN, ZOLMITRIPTAN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

INVENTIA HLTHCARE

* INVENTIA HEALTHCARE PRIVATE LTD

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

TELMISARTAN, TELMISARTAN

B - 78

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

IPCA LABS LTD

* IPCA LABORATORIES LTD

ALLOPURINOL, ALLOPURINOL

ATENOLOL, ATENOLOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

FUROSEMIDE, FUROSEMIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

IPR

* IPR PHARMACEUTICALS INC

CRESTOR, ROSUVASTATIN CALCIUM

ZOMIG, ZOLMITRIPTAN

IPR PHARMS INC

* IPR PHARMACEUTICALS INC

CAPRELSA, VANDETANIB

IPSEN INC

* IPSEN BIOPHARMACEUTICALS INC

INCRELEX, MECASERMIN RECOMBINANT

IPSEN PHARMA

* IPSEN PHARMA BIOTECH SAS

SOMATULINE DEPOT, LANREOTIDE ACETATE

IROKO PHARMS

* IROKO PHARMACEUTICALS LLC

INDOCIN, INDOMETHACIN

IROKO PHARMS LLC

* IROKO PHARMACEUTICALS LLC

TIVORBEX, INDOMETHACIN

VIVLODEX, MELOXICAM

ZORVOLEX, DICLOFENAC

ISO TEX

* ISO TEX DIAGNOSTICS INC

JEANATOPE, ALBUMIN IODINATED I-125 SERUM

MEGATOPE, ALBUMIN IODINATED I-131 SERUM

ISOTEX

* ISOTEX DIAGNOSTICS

GLOFIL-125, IOTHALAMATE SODIUM I-125

ISTITUTO BIO ITA SPA

* ISTITUTO BIOCHIMICO ITALIANO SPA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

NAFCILLIN SODIUM, NAFCILLIN SODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PIPERACILLIN, PIPERACILLIN SODIUM

IVAX INTL

* IVAX INTERNATIONAL GMBH

AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE

SYNRIBO, OMACETAXINE MEPESUCCINATE

IVAX PHARMS

* IVAX PHARMACEUTICALS INC

VALSARTAN, VALSARTAN

IVAX PHARMS INC

* IVAX PHARMACEUTICALS INC

OLANZAPINE, OLANZAPINE

B - 79

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 80

PRODUCT NAME SORTED BY APPLICANT

**

**

IVAX SUB TEVA PHARMS

* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUMETANIDE, BUMETANIDE

CABERGOLINE, CABERGOLINE

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CIMETIDINE, CIMETIDINE
(OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLOZAPINE, CLOZAPINE

CYCLOSPORINE, CYCLOSPORINE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE
(OTC)

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUTAMIDE, FLUTAMIDE

FUROSEMIDE, FUROSEMIDE

GABAPENTIN, GABAPENTIN

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

INDOMETHACIN, INDOMETHACIN

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

METHYLDOPA, METHYLDOPA

MISOPROSTOL, MISOPROSTOL

NADOLOL, NADOLOL

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

OXAPROZIN, OXAPROZIN

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

SIMVASTATIN, SIMVASTATIN

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

**

**

J AND J CONSUMER INC

* JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION

CHILDREN'S MOTRIN COLD, IBUPROFEN

(OTC)

CHILDREN'S MOTRIN, IBUPROFEN

(OTC)

CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE

(OTC)

IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE

(OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE

(OTC)

IMODIUM, LOPERAMIDE HYDROCHLORIDE

JUNIOR STRENGTH MOTRIN, IBUPROFEN

(OTC)

MOTRIN IB, IBUPROFEN

(OTC)

PEPCID AC , FAMOTIDINE
(OTC)

PEPCID AC, FAMOTIDINE

(OTC)

PEPCID COMPLETE, CALCIUM CARBONATE

(OTC)

SINE-AID IB, IBUPROFEN

(OTC)

SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE

(OTC)

TYLENOL , ACETAMINOPHEN
(OTC)

ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 81

PRODUCT NAME SORTED BY APPLICANT

**

**

* JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION

ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

ZYRTEC, CETIRIZINE HYDROCHLORIDE

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE

(OTC)

JACOBUS

* JACOBUS PHARMACEUTICAL CO

DAPSONE, DAPSONE

PASER, AMINOSALICYLIC ACID

JAI PHARMA LTD

* JAI PHARMA LTD

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL
(OTC)

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

JANSSEN BIOTECH

* JANSSEN BIOTECH INC

ZYTIGA, ABIRATERONE ACETATE

JANSSEN PHARMS

* JANSSEN PHARMACEUTICALS INC

AXERT, ALMOTRIPTAN MALATE

CONCERTA, METHYLPHENIDATE HYDROCHLORIDE

DITROPAN XL, OXYBUTYNIN CHLORIDE

DURAGESIC-100, FENTANYL

DURAGESIC-12, FENTANYL

DURAGESIC-25, FENTANYL

DURAGESIC-50, FENTANYL

DURAGESIC-75, FENTANYL

ELMIRON, PENTOSAN POLYSULFATE SODIUM

HALDOL, HALOPERIDOL DECANOATE

HALDOL, HALOPERIDOL LACTATE

INVEGA SUSTENNA, PALIPERIDONE PALMITATE

INVEGA TRINZA, PALIPERIDONE PALMITATE

INVEGA, PALIPERIDONE

INVOKAMET, CANAGLIFLOZIN

INVOKANA, CANAGLIFLOZIN

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVAQUIN, LEVOFLOXACIN

MICRONOR, NORETHINDRONE

MODICON 28, ETHINYL ESTRADIOL

NIZORAL, KETOCONAZOLE

ORTHO CYCLEN-28, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL

ORTHO-CEPT, DESOGESTREL

ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL

ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL

PANCREAZE, PANCRELIPASE (AMYLASE

RAZADYNE ER, GALANTAMINE HYDROBROMIDE

RAZADYNE, GALANTAMINE HYDROBROMIDE

RISPERDAL CONSTA, RISPERIDONE

RISPERDAL, RISPERIDONE

SPORANOX, ITRACONAZOLE

TERAZOL 3, TERCONAZOLE

TERAZOL 7, TERCONAZOLE

TOPAMAX, TOPIRAMATE

TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN

TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN

ULTRACET, ACETAMINOPHEN

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* JANSSEN PHARMACEUTICALS INC

ULTRAM, TRAMADOL HYDROCHLORIDE

XARELTO, RIVAROXABAN

JANSSEN PRODS

* JANSSEN PRODUCTS LP

EDURANT, RILPIVIRINE HYDROCHLORIDE

OLYSIO, SIMEPREVIR SODIUM

PREZCOBIX, COBICISTAT

PREZISTA, DARUNAVIR ETHANOLATE

YONDELIS, TRABECTEDIN

JANSSEN R AND D

* JANSSEN RESEARCH AND DEVELOPMENT LLC

INTELENCE, ETRAVIRINE

JANSSEN RES AND DEV

* JANSSEN RESEARCH AND DEVELOPMENT LLC

DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

JANSSEN THERAP

* JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP

SIRTURO, BEDAQUILINE FUMARATE

JAVELIN PHARMS INC

* JAVELIN PHARMACEUTICALS INC A WHOLLY OWNED SUDSIDIARY OF HOSPIRA INC

DYLOJECT, DICLOFENAC SODIUM

JAZZ PHARMS

* JAZZ PHARMACEUTICALS INC

LUVOX CR, FLUVOXAMINE MALEATE

XYREM, SODIUM OXYBATE

JAZZ PHARMS III

* JAZZ PHARMACEUTICALS III INTERNATIONAL LTD

FAZACLO ODT, CLOZAPINE

* JAZZ PHARMACEUTICALS INTERNATIONAL III

VERSACLOZ, CLOZAPINE

JAZZ PHARMS INTL

* JAZZ PHARMACEUTICALS INTERNATIONAL LTD

PRIALT, ZICONOTIDE ACETATE

JIANGSU HANSOH PHARM

* JIANGSU HANSOH PHARMACEUTICAL CO LTD

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

JIANGSU HENGRUI MED

* JIANGSU HENGRUI MEDICINE CO LTD

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LETROZOLE, LETROZOLE

OXALIPLATIN, OXALIPLATIN

JOHNS HOPKINS UNIV

* JOHNS HOPKINS UNIV

AMMONIA N 13, AMMONIA N-13

JOHNSON AND JOHNSON

* JOHNSON AND JOHNSON CONSUMER INC

VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE

(OTC)

VISINE-A, NAPHAZOLINE HYDROCHLORIDE

(OTC)

* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES

MEN'S ROGAINE, MINOXIDIL

(OTC)

ROGAINE (FOR MEN), MINOXIDIL

(OTC)

ROGAINE (FOR WOMEN), MINOXIDIL

(OTC)

ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL

(OTC)

WOMEN'S ROGAINE, MINOXIDIL

(OTC)

* JOHNSON AND JOHNSON HEALTHCARE PRODUCTS DIV MCNEIL-PPC INC

NIZORAL A-D, KETOCONAZOLE

(OTC)

JUBILANT CADISTA

* JUBILANT CADISTA PHARMACEUTICALS INC

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

B - 82

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** J

**

* JUBILANT CADISTA PHARMACEUTICALS INC

METHYLPREDNISOLONE, METHYLPREDNISOLONE

PREDNISONE, PREDNISONE

PROCOMP, PROCHLORPERAZINE MALEATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

JUBILANT DRAXIMAGE

* JUBILANT DRAXIMAGE INC

AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT

DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE

HICON, SODIUM IODIDE I-131

PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

SODIUM IODIDE I-131, SODIUM IODIDE I-131

JUBILANT GENERICS

* JUBILANT GENERICS LTD

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

INDOMETHACIN, INDOMETHACIN

IRBESARTAN, IRBESARTAN

LAMOTRIGINE, LAMOTRIGINE

LEVOFLOXACIN, LEVOFLOXACIN

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

OLANZAPINE, OLANZAPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RISPERIDONE, RISPERIDONE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SPIRONOLACTONE, SPIRONOLACTONE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALSARTAN, VALSARTAN

ZOLMITRIPTAN, ZOLMITRIPTAN

STEVENS J

* JEROME STEVENS PHARMACEUTICALS INC

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

DIGOXIN, DIGOXIN

METHOCARBAMOL AND ASPIRIN, ASPIRIN

UNITHROID, LEVOTHYROXINE SODIUM **

**

**

GRIFFEN
* KW GRIFFEN CO
BIOSCRUB, CHLORHEXIDINE GLUCONATE
(OTC)
KALEO INC
* KALEO INC
EVZIO, NALOXONE HYDROCHLORIDE
KEN LIFESCIENCE
* KEN LIFESCIENCE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

KERYX BIOPHARMS

* KERYX BIOPHARMACEUTICALS INC

AURYXIA, FERRIC CITRATE

KETTERING MEDCTR

* KETTERING MEDCTR

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

KING PHARMS

* KING PHARMACEUTICALS INC

ALTACE, RAMIPRIL

BICILLIN C-R 900/300, PENICILLIN G BENZATHINE

BICILLIN C-R, PENICILLIN G BENZATHINE

BICILLIN L-A, PENICILLIN G BENZATHINE

B - 83

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* KING PHARMACEUTICALS INC

CORZIDE, BENDROFLUMETHIAZIDE

PENICILLIN G PROCAINE, PENICILLIN G PROCAINE

SILVADENE, SILVER SULFADIAZINE

SKELAXIN, METAXALONE

SYNERCID, DALFOPRISTIN

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC

TAPAZOLE, METHIMAZOLE

TUSSIGON, HOMATROPINE METHYLBROMIDE

KING PHARMS R AND D

* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC

CYTOMEL, LIOTHYRONINE SODIUM

LEVOXYL, LEVOTHYROXINE SODIUM **

KNIGHT THERAPS

* KNIGHT THERAPEUTICS USA INC

IMPAVIDO, MILTEFOSINE

KOWA CO

* KOWA CO LTD

LIVALO, PITAVASTATIN CALCIUM

KREITCHMAN PET CTR

* KREITCHMAN PET CENTER

AMMONIA N 13, AMMONIA N-13

KREMERS URBAN DEV

* KREMERS URBAN DEVELOPMENT CO

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

KREMERS URBAN PHARMS

* KREMERS URBAN PHARMACEUTICALS INC

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

GLYCOLAX, POLYETHYLENE GLYCOL 3350

GLYCOLAX, POLYETHYLENE GLYCOL 3350

(OTC)

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MONOKET, ISOSORBIDE MONONITRATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

OMEPRAZOLE, OMEPRAZOLE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

KRKA TOVARNA ZDRAVIL

* KRKA TOVARNA ZDRAVIL DD NOVO MESTO

LANSOPRAZOLE , LANSOPRAZOLE

KUDCO IRELAND

* KUDCO IRELAND LTD

LETROZOLE, LETROZOLE

KVK TECH

* KVK TECH INC

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

KALEXATE, SODIUM POLYSTYRENE SULFONATE

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

KYTHERA BIOPHARMS

* KYTHERA BIOPHARMACEUTICALS INC

KYBELLA, DEOXYCHOLIC ACID

**
L PERRIGO CO

* L PERRIGO CO

LEVOCETIRIZINE DIHYDROCHLORIDE,
LAB HRA PHARMA

* LABORATOIRE HRA PHARMA

ELLA, ULIPRISTAL ACETATE

**

LEVOCETIRIZINE DIHYDROCHLORIDE

B - 84

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

LANDELA PHARM

* LANDELA PHARMACEUTICAL

ALBUTEROL SULFATE, ALBUTEROL SULFATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LANNETT

* LANNETT CO INC

ACETAZOLAMIDE, ACETAZOLAMIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

LANIAZID, ISONIAZID

LANORINAL, ASPIRIN

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

PROBALAN, PROBENECID

* LANNETT HOLDINGS INC

BACLOFEN, BACLOFEN

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

DANAZOL, DANAZOL

DIPYRIDAMOLE, DIPYRIDAMOLE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

TERBUTALINE SULFATE, TERBUTALINE SULFATE

URSODIOL, URSODIOL

LANNETT HOLDINGS INC

* LANNETT HOLDINGS INC

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CODEINE SULFATE, CODEINE SULFATE

DIAZEPAM, DIAZEPAM

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LETROZOLE, LETROZOLE

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

METHOCARBAMOL, METHOCARBAMOL

MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LANTHEUS MEDCL

* LANTHEUS MEDICAL IMAGING INC

ABLAVAR, GADOFOSVESET TRISODIUM

CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT

DEFINITY, PERFLUTREN

GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67

NEUROLITE, TECHNETIUM TC-99M BICISATE KIT

TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

XENON XE 133, XENON XE-133

LANTHEUS MEDICAL

* LANTHEUS MEDICAL IMAGING INC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

LARKEN LABS

B - 85

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* LARKEN LABORATORIES INC

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

OFLOXACIN, OFLOXACIN

LARKEN LABS INC

* LARKEN LABORATORIES INC

ALLZITAL, ACETAMINOPHEN

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

LAVIPHARM LABS

* LAVIPHARM LABORATORIES INC

FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

LEADING PHARMA LLC

* LEADING PHARMA LLC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

FOLIC ACID, FOLIC ACID

FUROSEMIDE, FUROSEMIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

LEHIGH VALLEY

* LEHIGH VALLEY TECHNOLOGIES INC

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

LEK PHARMS

* LEK PHARMACEUTICALS D D

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

LEK PHARMS DD

* LEK PHARMACEUTICALS DD

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

LEO PHARMA AS

* LEO PHARMA AS

DOVONEX, CALCIPOTRIENE

ENSTILAR, BETAMETHASONE DIPROPIONATE

PICATO, INGENOL MEBUTATE

TACLONEX, BETAMETHASONE DIPROPIONATE

LG LIFE

* LG LIFE SCIENCES LTD

VALTROPIN, SOMATROPIN RECOMBINANT

LG LIFE SCIENCES

* LG LIFE SCIENCES LTD

FACTIVE, GEMIFLOXACIN MESYLATE

LIEBEL-FLARSHEIM

* LIEBEL-FLARSHEIM CO LLC

CONRAY 30, IOTHALAMATE MEGLUMINE

CONRAY 43, IOTHALAMATE MEGLUMINE

CONRAY, IOTHALAMATE MEGLUMINE

CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE

MD-76R, DIATRIZOATE MEGLUMINE

MD-GASTROVIEW, DIATRIZOATE MEGLUMINE

OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE

OPTIMARK, GADOVERSETAMIDE

OPTIRAY 240, IOVERSOL

OPTIRAY 300, IOVERSOL

OPTIRAY 320, IOVERSOL

OPTIRAY 350, IOVERSOL

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

LLOYD

* LLOYD INC

LEVOTHROID, LEVOTHYROXINE SODIUM **

LNK

* LNK INTERNATIONAL INC

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE

(OTC)

B - 86

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* LNK INTERNATIONAL INC

IBUPROFEN, IBUPROFEN
(OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

LOREAL USA

* LOREAL USA PRODUCTS INC

ANTHELIOS 20, AVOBENZONE

(OTC)

ANTHELIOS 40, AVOBENZONE

(OTC)

ANTHELIOS SX, AVOBENZONE

(OTC)

CAPITAL SOLEIL 15, AVOBENZONE

(OTC)

LOTUS PHARM CO LTD

* LOTUS PHARMACEUTICAL CO LTD

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL, LEVONORGESTREL
(OTC)

LUITPOLD

* LUITPOLD PHARMACEUTICALS INC

ACETYLCYSTEINE, ACETYLCYSTEINE

ADENOSINE, ADENOSINE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMINOPHYLLINE, AMINOPHYLLINE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE

BROMFENAC SODIUM, BROMFENAC SODIUM

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CYANOCOBALAMIN, CYANOCOBALAMIN

CYCLOSPORINE, CYCLOSPORINE

DACTINOMYCIN, DACTINOMYCIN

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXFERRUM, IRON DEXTRAN

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DROPERIDOL, DROPERIDOL

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ESTRADIOL VALERATE, ESTRADIOL VALERATE

ETOMIDATE, ETOMIDATE

FOMEPIZOLE, FOMEPIZOLE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GANCICLOVIR, GANCICLOVIR SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IBUTILIDE FUMARATE, IBUTILIDE FUMARATE

INJECTAFER, FERRIC CARBOXYMALTOSE

LATANOPROST, LATANOPROST

LEVETIRACETAM, LEVETIRACETAM

LEVOCARNITINE, LEVOCARNITINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MANNITOL 25%, MANNITOL

METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NITROGLYCERIN, NITROGLYCERIN

OLANZAPINE, OLANZAPINE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PHENYTOIN SODIUM, PHENYTOIN SODIUM

B - 87

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* LUITPOLD PHARMACEUTICALS INC

PROGESTERONE, PROGESTERONE

TRANEXAMIC ACID, TRANEXAMIC ACID

TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

VENOFER, IRON SUCROSE

ZIDOVUDINE, ZIDOVUDINE

LUKARE MEDICAL LLC

* LUKARE MEDICAL LLC

ELLIOTTS B SOLUTION, CALCIUM CHLORIDE

LUMARA HEALTH INC

* LUMARA HEALTH INC

MAKENA, HYDROXYPROGESTERONE CAPROATE

LUNDBECK LLC

* LUNDBECK LLC

ONFI, CLOBAZAM

SABRIL, VIGABATRIN

LUNDBECK NA LTD

* LUNDBECK NA LTD

NORTHERA, DROXIDOPA

LUPIN

* LUPIN LTD

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOVASTATIN, LOVASTATIN

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

TOPIRAMATE, TOPIRAMATE

TRANDOLAPRIL, TRANDOLAPRIL

LUPIN ATLANTIS

* LUPIN ATLANTIS HOLDINGS SA

ANTARA (MICRONIZED), FENOFIBRATE

LUPIN LTD

* LUPIN LIMITED

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

* LUPIN LTD

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

AZITHROMYCIN, AZITHROMYCIN

BEKYREE, DESOGESTREL

BIMATOPROST, BIMATOPROST

BLISOVI 24 FE, ETHINYL ESTRADIOL

BLISOVI FE 1.5/30, ETHINYL ESTRADIOL

BLISOVI FE 1/20, ETHINYL ESTRADIOL

CALCIUM ACETATE, CALCIUM ACETATE

CELECOXIB, CELECOXIB

CIPROFLOXACIN, CIPROFLOXACIN

CLARITHROMYCIN, CLARITHROMYCIN

B - 88

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* LUPIN LTD

DAYSEE, ETHINYL ESTRADIOL

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENSKYCE, DESOGESTREL

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESZOPICLONE, ESZOPICLONE

FALLBACK SOLO, LEVONORGESTREL

(OTC)

FAMOTIDINE, FAMOTIDINE

FENOFIBRATE, FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FYAVOLV, ETHINYL ESTRADIOL

GATIFLOXACIN, GATIFLOXACIN

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

JENCYCLA, NORETHINDRONE

KAITLIB FE, ETHINYL ESTRADIOL

KURVELO, ETHINYL ESTRADIOL

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEFENAMIC ACID, MEFENAMIC ACID

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NABUMETONE, NABUMETONE

NIACIN, NIACIN

NIKKI, DROSPIRENONE

NORETHINDRONE, NORETHINDRONE

OMEPRAZOLE, OMEPRAZOLE

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIRMELLA 1/35, ETHINYL ESTRADIOL

PIRMELLA 7/7/7, ETHINYL ESTRADIOL

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUININE SULFATE, QUININE SULFATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RANOLAZINE, RANOLAZINE

REPAGLINIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

RIFABUTIN, RIFABUTIN

SUPRAX, CEFIXIME

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VYFEMLA, ETHINYL ESTRADIOL

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

LUPIN PHARMS

* LUPIN PHARMACEUTICALS INC

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

B - 89

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* LUPIN PHARMACEUTICALS INC

DESLORATADINE, DESLORATADINE

MELOXICAM, MELOXICAM

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RIFAMPIN, RIFAMPIN

SUPRAX, CEFIXIME

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

LYNE

* LYNE LABORATORIES INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DEXAMETHASONE, DEXAMETHASONE

ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

LEVOCARNITINE, LEVOCARNITINE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PERRIGO

* L PERRIGO CO

ACETAMINOPHEN, ACETAMINOPHEN
(OTC)

ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN

(OTC)

CHILDREN'S IBUPROFEN, IBUPROFEN

(OTC)

CROMOLYN SODIUM, CROMOLYN SODIUM

(OTC)

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE

(OTC)

FAMOTIDINE, FAMOTIDINE
(OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN

(OTC)

IBUPROFEN, IBUPROFEN
(OTC)

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE

(OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

LORATADINE, LORATADINE
(OTC)

MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE

(OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL

(OTC)

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM

(OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

TAB-PROFEN, IBUPROFEN
(OTC)

TIOCONAZOLE, TIOCONAZOLE
(OTC)

**

**

MA GENERAL HOSP

* MASSACHUSETTS GENERAL HOSP

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

MACLEODS PHARMS LTD

* MACLEODS PHARMACEUTICALS LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESZOPICLONE, ESZOPICLONE

FAMCICLOVIR, FAMCICLOVIR

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

OLANZAPINE, OLANZAPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

B - 90

B - 91

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MACLEODS PHARMACEUTICALS LTD

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

MALLINCKRODT

* MALLINCKRODT CHEMICAL INC

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE

* MALLINCKRODT INC

ANEXSIA 5/325, ACETAMINOPHEN

ANEXSIA 7.5/325, ACETAMINOPHEN

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

FENTANYL CITRATE, FENTANYL CITRATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHYLIN, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

OXYCET, ACETAMINOPHEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

* MALLINCKRODT MEDICAL INC

INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE

OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT

ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

MALLINCKRODT ARD

* MALLINCKRODT ARD INC

H.P. ACTHAR GEL, CORTICOTROPIN

MALLINCKRODT INC

* MALLINCKRODT INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE,

EXALGO, HYDROMORPHONE HYDROCHLORIDE

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

GABLOFEN, BACLOFEN

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

RESTORIL, TEMAZEPAM

ROXICODONE, OXYCODONE HYDROCHLORIDE

TOFRANIL, IMIPRAMINE HYDROCHLORIDE

TOFRANIL-PM, IMIPRAMINE PAMOATE

XARTEMIS XR, ACETAMINOPHEN

MALLINCKRODT IP

* MALLINCKRODT IP

AMPHETAMINE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MALLINCKRODT IP

OFIRMEV, ACETAMINOPHEN

MALLINCKRODT LLC

* MALLINCKRODT LLC

ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE

PAMELOR, NORTRIPTYLINE HYDROCHLORIDE

MALLINKRODT NUCLEAR

* MALLINCKRODT NUCLEAR MEDICINE LLC

GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67

SODIUM IODIDE I 123, SODIUM IODIDE I-123

SODIUM IODIDE I 131, SODIUM IODIDE I-131

TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT

TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT

TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT

TECHNETIUM TC-99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT

MARATHON PHARMS

* MARATHON PHARMACEUTICALS LLC

SECONAL SODIUM, SECOBARBITAL SODIUM

MARKSANS PHARMA

* MARKSANS PHARMA LTD

GABAPENTIN, GABAPENTIN

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN
(OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

NAPROXEN, NAPROXEN

MATAWAN PHARMS

* MATAWAN PHARMACEUTICALS LLC

TRETINOIN, TRETINOIN

MATRIX LABS LTD

* MATRIX LABORATORIES LTD

NIFEDIPINE, NIFEDIPINE

STAVUDINE, STAVUDINE

MAYER LABS INC

* MAYER LABORATORIES INC

TODAY, NONOXYNOL-9
(OTC)

MAYNE PHARMA

* MAYNE PHARMA INTERNATIONAL PTY LTD

DORYX, DOXYCYCLINE HYCLATE

DOXTERIC, DOXYCYCLINE HYCLATE

ERYC, ERYTHROMYCIN

MCGUFF

* MCGUFF PHARMACEUTICALS INC

HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE

MCNEIL

* MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC

IBUPROFEN, IBUPROFEN
(OTC)

MCNEIL CONS

* MCNEIL CONSUMER HEALTHCARE

SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE

(OTC)

MCPRF

* MAYO CLINIC PET RADIOCHEMISTRY FACILITY

AMMONIA N 13, AMMONIA N-13

CHOLINE C-11, CHOLINE C-11

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MEDA PHARMS

* MEDA PHARMACEUTICALS

DYMISTA, AZELASTINE HYDROCHLORIDE

EDLUAR, ZOLPIDEM TARTRATE

* MEDA PHARMACEUTICALS INC

ANADROL-50, OXYMETHOLONE

B - 92

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MEDA PHARMACEUTICALS INC

ASTELIN, AZELASTINE HYDROCHLORIDE

AVC, SULFANILAMIDE

BUTISOL SODIUM, BUTABARBITAL SODIUM

CESAMET, NABILONE

COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

COLYTE, POLYETHYLENE GLYCOL 3350

CORTIFOAM, HYDROCORTISONE ACETATE

DEMADEX, TORSEMIDE

DEPEN, PENICILLAMINE

DIPENTUM, OLSALAZINE SODIUM

ELESTRIN, ESTRADIOL

EPIFOAM, HYDROCORTISONE ACETATE

FELBATOL, FELBAMATE

GASTROCROM, CROMOLYN SODIUM

LUFYLLIN, DYPHYLLINE

MUSE, ALPROSTADIL

OPTIVAR, AZELASTINE HYDROCHLORIDE

PROCTOFOAM HC, HYDROCORTISONE ACETATE

ROWASA, MESALAMINE

SFROWASA, MESALAMINE

TRILYTE, POLYETHYLENE GLYCOL 3350

* MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC

ASTEPRO, AZELASTINE HYDROCHLORIDE

SOMA COMPOUND W/ CODEINE, ASPIRIN

SOMA COMPOUND, ASPIRIN

SOMA, CARISOPRODOL

MEDA PHARMS INC

* MEDA PHARMACEUTICALS INC

AEROSPAN HFA, FLUNISOLIDE

MEDAC PHARMA INC

* MEDAC PHARMA INC

RASUVO, METHOTREXATE

MEDEFIL INC

* MEDEFIL INC

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

MEDICINES360

* MEDICINES360

LILETTA, LEVONORGESTREL

MEDICIS

* MEDICIS PHARMACEUTICAL CORP

ALDARA, IMIQUIMOD

AMMONUL, SODIUM BENZOATE

CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ESTRASORB, ESTRADIOL HEMIHYDRATE

LOPROX, CICLOPIROX

LUZU, LULICONAZOLE

METROGEL-VAGINAL, METRONIDAZOLE

MINITRAN, NITROGLYCERIN

SOLODYN, MINOCYCLINE HYDROCHLORIDE

SYNACORT, HYDROCORTISONE

VANOS, FLUOCINONIDE

ZIANA, CLINDAMYCIN PHOSPHATE

ZYCLARA, IMIQUIMOD

MEDICURE

* MEDICURE INTERNATIONAL INC

AGGRASTAT, TIROFIBAN HYDROCHLORIDE

MEDIGENE AG

* MEDIGENE AG

VEREGEN, SINECATECHINS

MEDIMETRIKS PHARMS

* MEDIMETRIKS PHARMACEUTICALS INC

LOPROX, CICLOPIROX

NEO-SYNALAR, FLUOCINOLONE ACETONIDE

B - 93

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MEDIMETRIKS PHARMACEUTICALS INC

SYNALAR, FLUOCINOLONE ACETONIDE

MEDTECH PRODUCTS

* MEDTECH PRODUCTS INC

MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE

MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE
(OTC)

MONISTAT 3, MICONAZOLE NITRATE

MONISTAT 3, MICONAZOLE NITRATE

(OTC)

MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MONISTAT 7, MICONAZOLE NITRATE

(OTC)

MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

NIX, PERMETHRIN
(OTC)

TAGAMET HB, CIMETIDINE

(OTC)

MEDTRONIC NEURO

* MEDTRONIC NEUROMODULATION

LIORESAL, BACLOFEN

MERCK

* MERCK AND CO INC

CANCIDAS, CASPOFUNGIN ACETATE

EMEND, APREPITANT

FOSAMAX PLUS D, ALENDRONATE SODIUM

FOSAMAX, ALENDRONATE SODIUM

MAXALT, RIZATRIPTAN BENZOATE

MAXALT-MLT, RIZATRIPTAN BENZOATE

PRIMAXIN, CILASTATIN SODIUM

PROSCAR, FINASTERIDE

SINGULAIR, MONTELUKAST SODIUM

ZOLINZA, VORINOSTAT

* MERCK RESEARCH LABORATORIES DIV MERCK CO INC

PRINIVIL, LISINOPRIL

PROPECIA, FINASTERIDE

SINGULAIR, MONTELUKAST SODIUM

TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

ZOCOR, SIMVASTATIN

MERCK AND CO INC

* MERCK AND CO INC

EMEND, FOSAPREPITANT DIMEGLUMINE

FOSAMAX, ALENDRONATE SODIUM

MERCK SHARP DOHME

* MERCK SHARP AND DOHME CORP

ASMANEX HFA, MOMETASONE FUROATE

ASMANEX TWISTHALER, MOMETASONE FUROATE

BELSOMRA, SUVOREXANT

CELESTONE SOLUSPAN, BETAMETHASONE ACETATE

CLARINEX D 24 HOUR, DESLORATADINE

CLARINEX, DESLORATADINE

CLARINEX-D 12 HOUR, DESLORATADINE

COZAAR, LOSARTAN POTASSIUM

CRIXIVAN, INDINAVIR SULFATE

DIPROLENE AF, BETAMETHASONE DIPROPIONATE

DIPROLENE, BETAMETHASONE DIPROPIONATE

DULERA, FORMOTEROL FUMARATE

ELOCON, MOMETASONE FUROATE

GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE

HYZAAR, HYDROCHLOROTHIAZIDE

INVANZ, ERTAPENEM SODIUM

ISENTRESS, RALTEGRAVIR POTASSIUM

JANUMET XR, METFORMIN HYDROCHLORIDE

JANUMET, METFORMIN HYDROCHLORIDE

JANUVIA, SITAGLIPTIN PHOSPHATE

LOTRISONE, BETAMETHASONE DIPROPIONATE

NASONEX, MOMETASONE FUROATE MONOHYDRATE

NITRO-DUR, NITROGLYCERIN

NOXAFIL, POSACONAZOLE

(OTC)

B - 94

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MERCK SHARP AND DOHME CORP

REBETOL, RIBAVIRIN

SINEMET CR, CARBIDOPA

SINEMET, CARBIDOPA

STROMECTOL, IVERMECTIN

TEMODAR, TEMOZOLOMIDE

VICTRELIS, BOCEPREVIR

ZONTIVITY, VORAPAXAR SULFATE

MERIDIAN MEDCL

* MERIDIAN MEDICAL TECHNOLOGIES INC

DUODOTE, ATROPINE

* MERIDIAN MEDICAL TECHNOLOGIES INC SUB KING PHARMACEUTICALS INC

ALSUMA, SUMATRIPTAN SUCCINATE

MERIDIAN MEDCL TECHN

* MERIDIAN MEDICAL TECHNOLOGIES INC

ATROPEN, ATROPINE

MORPHINE SULFATE, MORPHINE SULFATE

PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE

MERRIMACK PHARMS

* MERRIMACK PHARMACEUTICALS INC

ONIVYDE, IRINOTECAN HYDROCHLORIDE

MERRO PHARM

* MERRO PHARMACEUTICAL CO LTD

IBUPROFEN, IBUPROFEN
(OTC)

MERZ PHARMS

* MERZ PHARMACEUTICALS LLC

CUVPOSA, GLYCOPYRROLATE

NAFTIN, NAFTIFINE HYDROCHLORIDE

ONMEL, ITRACONAZOLE

METHAPHARM

* METHAPHARM INC

LEVETIRACETAM, LEVETIRACETAM

PROVOCHOLINE, METHACHOLINE CHLORIDE

MICRO LABS LTD

* MICRO LABS LTD

MEFENAMIC ACID, MEFENAMIC ACID

NEVIRAPINE, NEVIRAPINE

SIMVASTATIN, SIMVASTATIN

MICRO LABS LTD INDIA

* MICRO LABS LTD INDIA

CROMOLYN SODIUM, CROMOLYN SODIUM

GLIMEPIRIDE, GLIMEPIRIDE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

MIDWEST MEDCL

* MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MIKAH PHARMA

* MIKAH PHARMA LLC

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

MIKAH PHARMA LLC

* MIKAH PHARMA LLC

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

MIKART

* MIKART INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BENZONATATE, BENZONATATE

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTAPAP, ACETAMINOPHEN

B - 95

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MIKART INC

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CHLORZOXAZONE, CHLORZOXAZONE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ETHOSUXIMIDE, ETHOSUXIMIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PYRAZINAMIDE, PYRAZINAMIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

MIKART INC

* MIKART INC

HYCOFENIX, GUAIFENESIN

MILLENNIUM PHARMS

* MILLENNIUM PHARMACEUTICALS INC

NINLARO, IXAZOMIB CITRATE

VELCADE, BORTEZOMIB

MIPS CRF

* MIPS CYCLOTRON AND RADIOCHEMISTRY FACILITY

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MIRROR PHARMS

* MIRROR PHARMACEUTICALS LLC

CARISOPRODOL AND ASPIRIN, ASPIRIN

CARISOPRODOL, CARISOPRODOL

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PROBENECID AND COLCHICINE, COLCHICINE

MIRROR PHARMS LLC

* MIRROR PHARMACEUTICALS LLC

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

MISSION PHARMA

* MISSION PHARMACAL CO

BINOSTO, ALENDRONATE SODIUM

LITHOSTAT, ACETOHYDROXAMIC ACID

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

TEXACORT, HYDROCORTISONE

THIOLA, TIOPRONIN

TINDAMAX, TINIDAZOLE

UROCIT-K, POTASSIUM CITRATE

MISSION PHARMACAL CO

* MISSION PHARMACAL CO

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

FLOWTUSS, GUAIFENESIN

MIST PHARMS LLC

* MIST PHARMACEUTICALS LLC

NITROMIST, NITROGLYCERIN

MOBERG PHARMA NORTH

* MOBERG PHARMA NORTH AMERICA LLC

CHILDREN'S ELIXSURE, IBUPROFEN

(OTC)

MOBIUS THERAP

* MOBIUS THERAPEUTICS LLC

MITOSOL, MITOMYCIN

MOLNLYCKE HLTH

* MOLNLYCKE HEALTH CARE

HIBICLENS, CHLORHEXIDINE GLUCONATE

(OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE

(OTC)

MONARCH PHARMS

* MONARCH PHARMACEUTICALS INC

CORTISPORIN, BACITRACIN ZINC

B - 96

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MONARCH PHARMACEUTICALS INC

CORTISPORIN, HYDROCORTISONE ACETATE

CORTISPORIN, HYDROCORTISONE

MENEST, ESTROGENS, ESTERIFIED

NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE

NEOSPORIN, GRAMICIDIN

PEDIOTIC, HYDROCORTISONE

SEPTRA DS, SULFAMETHOXAZOLE

SEPTRA, SULFAMETHOXAZOLE

VIROPTIC, TRIFLURIDINE

MORTON GROVE

* MORTON GROVE PHARMACEUTICALS INC

LACTULOSE, LACTULOSE

MORTON GROVE PHARMS

* MORTON GROVE PHARMACEUTICALS INC

GENERLAC, LACTULOSE

MSD INTL

* MSD INTERNATIONAL GMBH

VYTORIN, EZETIMIBE

MSD INTL GMBH

* MSD INTERNATIONAL GMBH

ZETIA, EZETIMIBE

MSD MERCK CO

* MERCK SHARP AND DOHME CORP A SUBSIDIARY OF MERCK AND CO INC

EMEND, APREPITANT

MURTY PHARMS

* MURTY PHARMACEUTICALS INC

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

MUSTAFA NEVSAT

* MUSTAFA NEVSAT ILAC SANAYII AS

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

MUSTAFA NEVZAT

* MUSTAFA NEVZAT ILAC SANAYII AS

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

VECURONIUM BROMIDE, VECURONIUM BROMIDE

MUSTAFA NEVZAT ILAC

* MUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

MUTUAL PHARM

* MUTUAL PHARMACEUTICAL CO INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

BACTRIM DS, SULFAMETHOXAZOLE

BACTRIM, SULFAMETHOXAZOLE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ERGOLOID MESYLATES, ERGOLOID MESYLATES

FELODIPINE, FELODIPINE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LOVASTATIN, LOVASTATIN

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

MINOXIDIL, MINOXIDIL

NYSTATIN, NYSTATIN

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

B - 97

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MUTUAL PHARMACEUTICAL CO INC

PINDOLOL, PINDOLOL

PIROXICAM, PIROXICAM

PREDNISONE, PREDNISONE

PRIMIDONE, PRIMIDONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

QUINIDINE SULFATE, QUINIDINE SULFATE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULINDAC, SULINDAC

TEMAZEPAM, TEMAZEPAM

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

MUTUAL PHARM CO INC

* MUTUAL PHARMACEUTICAL CO INC

IBANDRONATE SODIUM, IBANDRONATE SODIUM

LEVETIRACETAM, LEVETIRACETAM

QUALAQUIN, QUININE SULFATE

MUTUAL PHARMA

* MUTUAL PHARMACAL CO

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

MYLAN

* MYLAN LABORATORIES INC

ACYCLOVIR, ACYCLOVIR

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

CAPTOPRIL, CAPTOPRIL

ETODOLAC, ETODOLAC

OLANZAPINE, OLANZAPINE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

* MYLAN PHARMACEUTICALS

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

* MYLAN PHARMACEUTICALS INC

ACARBOSE, ACARBOSE

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALLOPURINOL, ALLOPURINOL

ALPRAZOLAM, ALPRAZOLAM

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

AVITA, TRETINOIN

AZATHIOPRINE, AZATHIOPRINE

AZITHROMYCIN, AZITHROMYCIN

BACLOFEN, BACLOFEN

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

B - 98

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN PHARMACEUTICALS INC

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
BUDESONIDE, BUDESONIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
CHLOROTHIAZIDE, CHLOROTHIAZIDE
CHLORPROPAMIDE, CHLORPROPAMIDE
CHLORTHALIDONE, CHLORTHALIDONE
CILOSTAZOL, CILOSTAZOL
CIMETIDINE, CIMETIDINE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CLORPRES, CHLORTHALIDONE
CLOZAPINE, CLOZAPINE
CYSTAGON, CYSTEAMINE BITARTRATE
DIAZEPAM, DIAZEPAM
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ESTRADIOL, ESTRADIOL
ESTROPIPATE, ESTROPIPATE
ETIDRONATE DISODIUM, ETIDRONATE DISODIUM
ETOPOSIDE, ETOPOSIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
(OTC)
FELODIPINE, FELODIPINE
FENOFIBRATE, FENOFIBRATE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FLURBIPROFEN, FLURBIPROFEN
FLUTAMIDE, FLUTAMIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FUROSEMIDE, FUROSEMIDE
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

B - 99

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 100

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN PHARMACEUTICALS INC

GLIPIZIDE, GLIPIZIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDAPAMIDE, INDAPAMIDE

INDOMETHACIN, INDOMETHACIN

KETOCONAZOLE, KETOCONAZOLE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LAMOTRIGINE, LAMOTRIGINE

LATANOPROST, LATANOPROST

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE
(OTC)

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOVASTATIN, LOVASTATIN

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

MELOXICAM, MELOXICAM

MENTAX, BUTENAFINE HYDROCHLORIDE

MERCAPTOPURINE, MERCAPTOPURINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METHYLDOPA, METHYLDOPA

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIRTAZAPINE, MIRTAZAPINE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE

NADOLOL, NADOLOL

NAPROXEN, NAPROXEN

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NIFEDIPINE, NIFEDIPINE

NISOLDIPINE, NISOLDIPINE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

PENTOXIFYLLINE, PENTOXIFYLLINE

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

PHENYTEK, PHENYTOIN SODIUM

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN PHARMACEUTICALS INC

PIROXICAM, PIROXICAM

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

(OTC)

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PROBENECID, PROBENECID

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

STAVUDINE, STAVUDINE

SULINDAC, SULINDAC

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TACROLIMUS, TACROLIMUS

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TEMAZEPAM, TEMAZEPAM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

THIOTHIXENE, THIOTHIXENE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRANDOLAPRIL, TRANDOLAPRIL

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

URSODIOL, URSODIOL

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

ZALEPLON, ZALEPLON

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

MYLAN INSTITUTIONAL

* MYLAN INSTITUTIONAL INC

SULFAMYLON, MAFENIDE ACETATE

* MYLAN INSTITUTIONAL LLC

ACETYLCYSTEINE, ACETYLCYSTEINE

ALOPRIM, ALLOPURINOL SODIUM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ARGATROBAN, ARGATROBAN

CARBOPLATIN, CARBOPLATIN

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CIDOFOVIR, CIDOFOVIR

COSYNTROPIN, COSYNTROPIN

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

B - 101

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN INSTITUTIONAL LLC

DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

DURACLON, CLONIDINE HYDROCHLORIDE

ENLON, EDROPHONIUM CHLORIDE

ENLON-PLUS, ATROPINE SULFATE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

FOMEPIZOLE, FOMEPIZOLE

IBUTILIDE FUMARATE, IBUTILIDE FUMARATE

ISOSULFAN BLUE, ISOSULFAN BLUE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MESNA, MESNA

METHOCARBAMOL, METHOCARBAMOL

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

PENTOSTATIN, PENTOSTATIN

RIMSO-50, DIMETHYL SULFOXIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SCANLUX-300, IOPAMIDOL

SCANLUX-370, IOPAMIDOL

SOTRADECOL, SODIUM TETRADECYL SULFATE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

ULTIVA, REMIFENTANIL HYDROCHLORIDE

MYLAN IRELAND LTD

* MYLAN IRELAND LTD

ARIXTRA, FONDAPARINUX SODIUM

MIACALCIN, CALCITONIN SALMON

MYLAN LABS

* MYLAN LABORATORIES LTD

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

NEVIRAPINE, NEVIRAPINE

MYLAN LABS LTD

* MYLAN LABORATORIES LTD

ADENOSINE, ADENOSINE

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

CARBOPLATIN, CARBOPLATIN

CISPLATIN, CISPLATIN

CLADRIBINE, CLADRIBINE

CYTARABINE, CYTARABINE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE HYCLATE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ETOMIDATE, ETOMIDATE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUMAZENIL, FLUMAZENIL

FLUOROURACIL, FLUOROURACIL

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

B - 102

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 103

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN LABORATORIES LTD

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MESNA, MESNA

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

NAFCILLIN SODIUM, NAFCILLIN SODIUM

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXACILLIN SODIUM, OXACILLIN SODIUM

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

RIFAMPIN, RIFAMPIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VALSARTAN, VALSARTAN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

MYLAN PHARMS INC

* MYLAN PHARMACEUTICALS INC

ABACAVIR SULFATE, ABACAVIR SULFATE

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ACITRETIN, ACITRETIN

ACYCLOVIR, ACYCLOVIR

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

ALPRAZOLAM, ALPRAZOLAM

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMNESTEEM, ISOTRETINOIN

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE

AVITA, TRETINOIN

BACLOFEN, BACLOFEN

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CABERGOLINE, CABERGOLINE

CAPECITABINE, CAPECITABINE

CARBAMAZEPINE, CARBAMAZEPINE

CELECOXIB, CELECOXIB

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

CILOSTAZOL, CILOSTAZOL

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLONAZEPAM, CLONAZEPAM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOZAPINE, CLOZAPINE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DESLORATADINE, DESLORATADINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIDANOSINE, DIDANOSINE

DIGOXIN, DIGOXIN

DISULFIRAM, DISULFIRAM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN PHARMACEUTICALS INC

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

ENTACAPONE, ENTACAPONE

EPROSARTAN MESYLATE, EPROSARTAN MESYLATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESZOPICLONE, ESZOPICLONE

FELBAMATE, FELBAMATE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

FINASTERIDE, FINASTERIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

GABAPENTIN, GABAPENTIN

GLIPIZIDE, GLIPIZIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE

INDAPAMIDE, INDAPAMIDE

INDOMETHACIN, INDOMETHACIN

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

ISRADIPINE, ISRADIPINE

ITRACONAZOLE, ITRACONAZOLE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LANSOPRAZOLE, LANSOPRAZOLE

LEVETIRACETAM, LEVETIRACETAM

LINEZOLID, LINEZOLID

LITHIUM CARBONATE, LITHIUM CARBONATE

MAXZIDE, HYDROCHLOROTHIAZIDE

MAXZIDE-25, HYDROCHLOROTHIAZIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MESALAMINE, MESALAMINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHYCLOTHIAZIDE, METHYCLOTHIAZIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MODAFINIL, MODAFINIL

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MORPHINE SULFATE, MORPHINE SULFATE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MYCOPHENOLIC ACID, MYCOPHENOLIC ACID

NABUMETONE, NABUMETONE

NAPROXEN, NAPROXEN

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NEVIRAPINE, NEVIRAPINE

OLANZAPINE, OLANZAPINE

PALIPERIDONE, PALIPERIDONE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PHENYTOIN, PHENYTOIN

PINDOLOL, PINDOLOL

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIROXICAM, PIROXICAM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

B - 104

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN PHARMACEUTICALS INC

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUININE SULFATE, QUININE SULFATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

REPAGLINIDE, REPAGLINIDE

RILUZOLE, RILUZOLE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RISPERIDONE, RISPERIDONE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SIMVASTATIN, SIMVASTATIN

SUCRALFATE, SUCRALFATE

SUNITINIB MALATE, SUNITINIB MALATE

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

THEOPHYLLINE, THEOPHYLLINE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLAZAMIDE, TOLAZAMIDE

TOLBUTAMIDE, TOLBUTAMIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAZOLAM, TRIAZOLAM

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VORICONAZOLE, VORICONAZOLE

ZIDOVUDINE, ZIDOVUDINE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

ZONISAMIDE, ZONISAMIDE

* MYLAN PHARMACEUTICALS INC.

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

NIZATIDINE, NIZATIDINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

MYLAN SPECLT

* MYLAN SPECIALTY LP

ACCUNEB, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

CROMOLYN SODIUM, CROMOLYN SODIUM

DUONEB, ALBUTEROL SULFATE

EPIPEN JR., EPINEPHRINE

EPIPEN, EPINEPHRINE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

PERFOROMIST, FORMOTEROL FUMARATE

MYLAN TECHNOLOGIES

* MYLAN TECHNOLOGIES

XULANE, ETHINYL ESTRADIOL

* MYLAN TECHNOLOGIES INC

CLONIDINE, CLONIDINE

ESTRADIOL, ESTRADIOL

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-37, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-62, FENTANYL

FENTANYL-75, FENTANYL

FENTANYL-87, FENTANYL

LIDOCAINE, LIDOCAINE

B - 105

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN TECHNOLOGIES INC

NITROGLYCERIN, NITROGLYCERIN

MYLAN TEORANTA

* MYLAN TEORANTA

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

**

**

NATCO PHARMA

* NATCO PHARMA LTD

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

NATCO PHARMA LTD

* NATCO PHARMA LIMITED

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

* NATCO PHARMA LTD

ALPRAZOLAM, ALPRAZOLAM

ANASTROZOLE, ANASTROZOLE

CARISOPRODOL, CARISOPRODOL

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE, LANSOPRAZOLE
(OTC)

LETROZOLE, LETROZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

NAVIDEA BIOPHARMS

* NAVIDEA BIOPHARMACEUTICALS INC

LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT

NAVINTA LLC

* NAVINTA LLC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

FAMOTIDINE, FAMOTIDINE

FOMEPIZOLE, FOMEPIZOLE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

NCM USA BRONX LLC

* NCM USA BRONX LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

NEOS THERAP INC

* NEOS THERAPEUTICS INC

HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX

NEPHRON

* NEPHRON CORP

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

* NEPHRON PHARMACEUTICALS CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

NESHER PHARMS

* NESHER PHARMACEUTICALS USA LLC

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

MICRO-K 10, POTASSIUM CHLORIDE

MICRO-K, POTASSIUM CHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

NEW HAVEN PHARMS

* NEW HAVEN PHARMACEUTICALS INC

DURLAZA, ASPIRIN

NEW RIVER

* NEW RIVER PHARMACEUTICALS INC

PROFERDEX, IRON DEXTRAN

NEXGEN PHARMA

B - 106

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* NEXGEN PHARMA INC

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CHENODIOL, CHENODIOL

GLYCOPYRROLATE, GLYCOPYRROLATE

MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

(OTC)

NEXGEN PHARMA INC

* NEXGEN PHARMA INC

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

NEXTWAVE PHARMS

* NEXTWAVE PHARMACEUTICALS INC

QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE

NEXUS PHARMS

* NEXUS PHARMACEUTICALS INC

DICLOFENAC SODIUM, DICLOFENAC SODIUM

LEVOFLOXACIN, LEVOFLOXACIN

NIAGARA PHARMS

* NIAGARA PHARMACEUTICALS INC

PUR-WASH, PURIFIED WATER

(OTC)

NORTEC DEV ASSOC

* NORTEC DEVELOPMENT ASSOC INC

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

NORTHSTAR HLTHCARE

* NORTHSTAR HEALTHCARE HOLDINGS LTD

ALLOPURINOL, ALLOPURINOL

ATENOLOL, ATENOLOL

BACLOFEN, BACLOFEN

GEMFIBROZIL, GEMFIBROZIL

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

NOSTRUM LABS INC

* NOSTRUM LABORATORIES INC

CALCIUM ACETATE, CALCIUM ACETATE

PINDOLOL, PINDOLOL

NOSTRUM PHARMS LLC

* NOSTRUM PHARMACEUTICALS LLC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NOVA LABS LTD

* NOVA LABORATORIES LTD

PURIXAN, MERCAPTOPURINE

NOVARTIS

* NOVARTIS CONSUMER HEALTH INC

EXCEDRIN (MIGRAINE), ACETAMINOPHEN

(OTC)

LAMISIL AT, TERBINAFINE

(OTC)

LAMISIL AT, TERBINAFINE HYDROCHLORIDE

(OTC)

LAMISIL, TERBINAFINE HYDROCHLORIDE

(OTC)

PREVACID 24 HR, LANSOPRAZOLE

(OTC)

THRIVE, NICOTINE POLACRILEX

(OTC)

TRANSDERM SCOP, SCOPOLAMINE

VAGISTAT-1, TIOCONAZOLE
(OTC)

* NOVARTIS PHARMACEUTICALS CORP

AFINITOR, EVEROLIMUS

ARCAPTA NEOHALER, INDACATEROL MALEATE

CATAFLAM, DICLOFENAC POTASSIUM

COARTEM, ARTEMETHER

DESFERAL, DEFEROXAMINE MESYLATE

DIOVAN HCT, HYDROCHLOROTHIAZIDE

DIOVAN, VALSARTAN

ESTRADERM, ESTRADIOL

B - 107

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* NOVARTIS PHARMACEUTICALS CORP

EXELON, RIVASTIGMINE

EXELON, RIVASTIGMINE TARTRATE

EXFORGE HCT, AMLODIPINE BESYLATE

EXFORGE, AMLODIPINE BESYLATE

EXJADE, DEFERASIROX

FAMVIR, FAMCICLOVIR

FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE

FORADIL, FORMOTEROL FUMARATE

GILENYA, FINGOLIMOD

GLEEVEC, IMATINIB MESYLATE

HYDERGINE, ERGOLOID MESYLATES

LAMISIL, TERBINAFINE HYDROCHLORIDE

LAMPRENE, CLOFAZIMINE

LESCOL XL, FLUVASTATIN SODIUM

LESCOL, FLUVASTATIN SODIUM

LOPRESSOR, METOPROLOL TARTRATE

LOTREL, AMLODIPINE BESYLATE

MYFORTIC, MYCOPHENOLIC ACID

NEORAL, CYCLOSPORINE

OCUPRESS, CARTEOLOL HYDROCHLORIDE

RECLAST, ZOLEDRONIC ACID

REGITINE, PHENTOLAMINE MESYLATE

RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE

RITALIN, METHYLPHENIDATE HYDROCHLORIDE

RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE

SANDIMMUNE, CYCLOSPORINE

SANDOSTATIN LAR, OCTREOTIDE ACETATE

SANDOSTATIN, OCTREOTIDE ACETATE

SIGNIFOR, PASIREOTIDE DIASPARTATE

STARLIX, NATEGLINIDE

TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE

TAVIST-1, CLEMASTINE FUMARATE

(OTC)

TEGRETOL, CARBAMAZEPINE

TEGRETOL-XR, CARBAMAZEPINE

TEKTURNA HCT, ALISKIREN HEMIFUMARATE

TEKTURNA, ALISKIREN HEMIFUMARATE

TOBI PODHALER, TOBRAMYCIN

TRILEPTAL, OXCARBAZEPINE

TYZEKA, TELBIVUDINE

VIVELLE, ESTRADIOL

VIVELLE-DOT, ESTRADIOL

VOLTAREN, DICLOFENAC SODIUM

VOLTAREN-XR, DICLOFENAC SODIUM

ZOMETA, ZOLEDRONIC ACID

ZORTRESS, EVEROLIMUS

NOVARTIS PHARM

* NOVARTIS PHARMACEUTICAL CORP

AFINITOR DISPERZ, EVEROLIMUS

NOVARTIS PHARMS

* NOVARTIS PHARMACEUTICALS CORP

FEMARA, LETROZOLE

TOBI, TOBRAMYCIN

NOVARTIS PHARMS CORP

* NOVARTIS PHARMACEUTICALS CORP

ARRANON, NELARABINE

ENTRESTO, SACUBITRIL

FARYDAK, PANOBINOSTAT LACTATE

HYCAMTIN, TOPOTECAN HYDROCHLORIDE

JADENU, DEFERASIROX

MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE

ODOMZO, SONIDEGIB PHOSPHATE

PROMACTA, ELTROMBOPAG OLAMINE

SEEBRI, GLYCOPYRROLATE

B - 108

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 109

PRODUCT NAME SORTED BY APPLICANT

**

**

* NOVARTIS PHARMACEUTICALS CORP

SIGNIFOR LAR, PASIREOTIDE PAMOATE

TAFINLAR, DABRAFENIB MESYLATE

TYKERB, LAPATINIB DITOSYLATE

UTIBRON, GLYCOPYRROLATE

VOTRIENT, PAZOPANIB HYDROCHLORIDE

ZOFRAN ODT, ONDANSETRON

ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ZOFRAN, ONDANSETRON HYDROCHLORIDE

ZYKADIA, CERITINIB

NOVAST LABS

* NOVAST LABORATORIES CHINA LTD

NORETHINDRONE, NORETHINDRONE

NOVAST LABS LTD

* NOVAST LABORATORIES LTD

DASETTA 1/35, ETHINYL ESTRADIOL

DASETTA 7/7/7, ETHINYL ESTRADIOL

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

ELINEST, ETHINYL ESTRADIOL

FALMINA, ETHINYL ESTRADIOL

LARIN 1.5/30, ETHINYL ESTRADIOL

LARIN 1/20, ETHINYL ESTRADIOL

LARIN 24 FE, ETHINYL ESTRADIOL

LARIN FE 1.5/30, ETHINYL ESTRADIOL

LARIN FE 1/20, ETHINYL ESTRADIOL

LEVONEST, ETHINYL ESTRADIOL

MONO-LINYAH, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

PHILITH, ETHINYL ESTRADIOL

PIMTREA, DESOGESTREL

SETLAKIN, ETHINYL ESTRADIOL

TRI-LINYAH, ETHINYL ESTRADIOL

WERA, ETHINYL ESTRADIOL

YAELA, DROSPIRENONE

NOVEL LABS INC

* NOVEL LABORATORIES INC

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DOXYCYCLINE, DOXYCYCLINE

FAMOTIDINE, FAMOTIDINE

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL, LEVONORGESTREL
(OTC)

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MISOPROSTOL, MISOPROSTOL

MORPHINE SULFATE, MORPHINE SULFATE

NITROFURANTOIN, NITROFURANTOIN

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL,

PHENELZINE SULFATE, PHENELZINE SULFATE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

(OTC)

TEMAZEPAM, TEMAZEPAM

TINIDAZOLE, TINIDAZOLE

TRIMETHOPRIM, TRIMETHOPRIM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

NOVEN

* NOVEN PHARMACEUTICALS INC

MINIVELLE, ESTRADIOL

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

NOVEN PHARMS INC

* NOVEN PHARMACEUTICALS INC

COMBIPATCH, ESTRADIOL

DAYTRANA, METHYLPHENIDATE

NOVEN THERAP

* NOVEN THERAPEUTICS LLC

BRISDELLE, PAROXETINE MESYLATE

PEXEVA, PAROXETINE MESYLATE

NOVEX

* NOVEX PHARMA

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

NOVO NORDISK

* NOVO NORDISK PHARMACEUTICALS INC

GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT

NOVO NORDISK INC

* NOVO NORDISK INC

LEVEMIR FLEXPEN, INSULIN DETEMIR RECOMBINANT

LEVEMIR FLEXTOUCH, INSULIN DETEMIR RECOMBINANT

LEVEMIR, INSULIN DETEMIR RECOMBINANT

NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT

NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN

(OTC)

NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

(OTC)

NOVOLIN R, INSULIN RECOMBINANT HUMAN

(OTC)

NOVOLOG FLEXPEN, INSULIN ASPART RECOMBINANT

NOVOLOG FLEXTOUCH, INSULIN ASPART RECOMBINANT

NOVOLOG MIX 70/30 FLEXPEN, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG PENFILL, INSULIN ASPART RECOMBINANT

NOVOLOG, INSULIN ASPART RECOMBINANT

PRANDIMET, METFORMIN HYDROCHLORIDE

PRANDIN, REPAGLINIDE

RYZODEG 70/30, INSULIN ASPART

SAXENDA, LIRAGLUTIDE RECOMBINANT

TRESIBA, INSULIN DEGLUDEC

VAGIFEM, ESTRADIOL

VICTOZA, LIRAGLUTIDE RECOMBINANT

NOVOCOL

* NOVOCOL PHARMACEUTICAL INC

ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

NOVOCOL INC

* NOVOCOL INC

LIDOCAINE, LIDOCAINE

NPS PHARMS INC

* NPS PHARMACEUTICALS INC

GATTEX KIT, TEDUGLUTIDE RECOMBINANT

NU PHARM

* NU PHARM INC

DIVALPROEX SODIUM, DIVALPROEX SODIUM

NUVO PHARM INC

* NUVO PHARMACEUTICAL INC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

FOLIC ACID, FOLIC ACID

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

NUVO RES INC

* NUVO RESEARCH INC

PENNSAID, DICLOFENAC SODIUM

NYCOMED US

* NYCOMED US INC

TERCONAZOLE, TERCONAZOLE

**
OAK PHARMS

* OAK PHARMACEUTICALS INC

NEMBUTAL SODIUM, PENTOBARBITAL SODIUM

**

B - 110

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* OAK PHARMACEUTICALS INC

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

OAK PHARMS AKORN

* OAK PHARMACEUTICALS INC SUB AKORN INC

COGENTIN, BENZTROPINE MESYLATE

DIURIL, CHLOROTHIAZIDE SODIUM

OAK PHARMS INC

* OAK PHARMACEUTICALS INC

ZIOPTAN, TAFLUPROST

* OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC

AZASITE, AZITHROMYCIN

BETIMOL, TIMOLOL

COSOPT PF, DORZOLAMIDE HYDROCHLORIDE

COSOPT, DORZOLAMIDE HYDROCHLORIDE

XOPENEX, LEVALBUTEROL HYDROCHLORIDE

OC PHARMA

* OC PHARMA LLC

LEVONORGESTREL, LEVONORGESTREL
(OTC)

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

ODYSSEY PHARMS

* ODYSSEY PHARMACEUTICALS INC

ANTABUSE, DISULFIRAM

NYSTATIN, NYSTATIN

SURMONTIL, TRIMIPRAMINE MALEATE

URECHOLINE, BETHANECHOL CHLORIDE

VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE

OHM

* OHM CORP

IBUPROFEN, IBUPROFEN
(OTC)

OHM LABS

* OHM LABORATORIES INC

ACETAMINOPHEN, ACETAMINOPHEN
(OTC)

IBUPROHM COLD AND SINUS, IBUPROFEN

(OTC)

IBUPROHM, IBUPROFEN
(OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

OHM LABS INC

* OHM LABORATORIES INC

VALSARTAN, VALSARTAN

OLTA PHARMS

* OLTA PHARMACEUTICALS CORP

LINDANE, LINDANE

OMAN PHARM PRODUCTS

* OMAN PHARMACEUTICAL PRODUCTS CO LLC

NEOMYCIN SULFATE, NEOMYCIN SULFATE

OMEROS

* OMEROS CORP

OMIDRIA, KETOROLAC TROMETHAMINE

ONY

* ONY INC

INFASURF PRESERVATIVE FREE, CALFACTANT

ONYX PHARMS

* ONYX PHARMACEUTICALS INC

KYPROLIS, CARFILZOMIB

ORAPHARMA

* ORAPHARMA INC

ARESTIN, MINOCYCLINE HYDROCHLORIDE

ORCHID HLTHCARE

* ORCHID HEALTHCARE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

B - 111

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ORCHID HEALTHCARE

CEPHALEXIN, CEPHALEXIN

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ESZOPICLONE, ESZOPICLONE

FELODIPINE, FELODIPINE

GEMIFLOXACIN MESYLATE, GEMIFLOXACIN MESYLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

MODAFINIL, MODAFINIL

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZALEPLON, ZALEPLON

OREXO AB

* OREXO AB

ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE

ORGANON SUB MERCK

* ORGANON USA INC A SUBSIDIARY OF MERCK AND CO INC

BRIDION, SUGAMMADEX SODIUM

ORGANON USA INC

* ORGANON USA INC

DESOGEN, DESOGESTREL

FOLLISTIM AQ, FOLLITROPIN ALFA/BETA

GANIRELIX ACETATE, GANIRELIX ACETATE

NEXPLANON, ETONOGESTREL

NUVARING, ETHINYL ESTRADIOL

PREGNYL, GONADOTROPIN, CHORIONIC

REMERON SOLTAB, MIRTAZAPINE

REMERON, MIRTAZAPINE

ORIENT PHARMA CO LTD

* ORIENT PHARMA CO LTD

CARISOPRODOL, CARISOPRODOL

MIGLITOL, MIGLITOL

ORION CORP ORION

* ORION CORP ORION PHARMA

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

NADOLOL, NADOLOL

SPIRONOLACTONE, SPIRONOLACTONE

ORION PHARMA

* ORION PHARMA

COMTAN, ENTACAPONE

STALEVO 100, CARBIDOPA

STALEVO 125, CARBIDOPA

STALEVO 150, CARBIDOPA

STALEVO 200, CARBIDOPA

STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA

ORIT LABS LLC

* ORIT LABORATORIES LLC

BENZONATATE, BENZONATATE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

ERGOCALCIFEROL, ERGOCALCIFEROL

LEVETIRACETAM, LEVETIRACETAM

ORPHAN EUROPE

B - 112

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ORPHAN EUROPE

CARBAGLU, CARGLUMIC ACID

OSI PHARMS

* OSI PHARMACEUTICALS INC

TARCEVA, ERLOTINIB HYDROCHLORIDE

OSMOTICA PHARM

* OSMOTICA PHARMACEUTICAL CORP

NIFEDIPINE, NIFEDIPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

OSMOTICA PHARM CORP

* OSMOTICA PHARMACEUTICAL CORP

KHEDEZLA, DESVENLAFAXINE

OTONOMY INC

* OTONOMY INC

OTIPRIO, CIPROFLOXACIN

OTSUKA

* OTSUKA PHARMACEUTICAL CO LTD

ABILIFY, ARIPIPRAZOLE

PLETAL, CILOSTAZOL

OTSUKA AMERICA PHARM

* OTSUKA AMERICA PHARMACEUTICAL INC

SAMSCA, TOLVAPTAN

OTSUKA PHARM

* OTSUKA PHARMACEUTICAL CO LTD

BUSULFEX, BUSULFAN

OTSUKA PHARM CO LTD

* OTSUKA PHARMACEUTICAL CO LTD

ABILIFY MAINTENA KIT, ARIPIPRAZOLE

DACOGEN, DECITABINE

REXULTI, BREXPIPRAZOLE

OUTLOOK PHARMS

* OUTLOOK PHARMACEUTICALS INC

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

**

**

P AND L DEV LLC

* P AND L DEVELOPMENT LLC DBA PLD DEVELOPMENTS LLC

IBUPROFEN, IBUPROFEN
(OTC)

PACIFIC PHARMA

* PACIFIC PHARMA

TIMOLOL MALEATE, TIMOLOL MALEATE

* PACIFIC PHARMA INC

TIMOLOL MALEATE, TIMOLOL MALEATE

PACIRA PHARMS INC

* PACIRA PHARMACEUTICALS INC

DEPOCYT, CYTARABINE

EXPAREL, BUPIVACAINE

PACK PHARMS LLC

* PACK PHARMACEUTICALS LLC

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CROMOLYN SODIUM, CROMOLYN SODIUM

PADDOCK

* PADDOCK LABORATORIES INC

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

PADDOCK LABS

* PADDOCK LABORATORIES INC

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

PADDOCK LLC

* PADDOCK LABORATORIES LLC

BROMFENAC SODIUM, BROMFENAC SODIUM

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

CALCIUM ACETATE, CALCIUM ACETATE

B - 113

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 114

PRODUCT NAME SORTED BY APPLICANT

**

**

* PADDOCK LABORATORIES LLC

CICLOPIROX, CICLOPIROX

CLINDA-DERM, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

COLOCORT, HYDROCORTISONE

COMPRO, PROCHLORPERAZINE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE ,

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

KIONEX, SODIUM POLYSTYRENE SULFONATE

LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

LORAZEPAM, LORAZEPAM

MIDAMOR, AMILORIDE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NYSTOP, NYSTATIN

PODOFILOX, PODOFILOX

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

REPAGLINIDE, REPAGLINIDE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

PALADIN LABS

* PALADIN LABS USA INC

ANTIZOL, FOMEPIZOLE

PANACEA BIOTEC LTD

* PANACEA BIOTEC LTD

TACROLIMUS, TACROLIMUS

PAR FORM

* PAR FORMULATIONS PRIVATE LTD

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

MAFENIDE ACETATE, MAFENIDE ACETATE

PAR PHARM

* PAR PHARMACEUTICAL

NABUMETONE, NABUMETONE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

TESTOSTERONE, TESTOSTERONE

* PAR PHARMACEUTICAL INC

ALPRAZOLAM, ALPRAZOLAM

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

CABERGOLINE, CABERGOLINE

CALCITONIN-SALMON, CALCITONIN SALMON

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CLOMIPHENE CITRATE, CLOMIPHENE CITRATE

CLONAZEPAM, CLONAZEPAM

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DEXAMETHASONE, DEXAMETHASONE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PAR PHARMACEUTICAL INC

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

ESTAZOLAM, ESTAZOLAM

FENTANYL CITRATE, FENTANYL CITRATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUTAMIDE, FLUTAMIDE

GLIPIZIDE, GLIPIZIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYUREA, HYDROXYUREA

IBUPROFEN, IBUPROFEN
(OTC)

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEGACE ES, MEGESTROL ACETATE

MEGESTROL ACETATE, MEGESTROL ACETATE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METRONIDAZOLE, METRONIDAZOLE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL, MINOXIDIL

NASCOBAL, CYANOCOBALAMIN

NATEGLINIDE, NATEGLINIDE

NIFEDIPINE, NIFEDIPINE

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

OXANDROLONE, OXANDROLONE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PIMOZIDE, PIMOZIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

(OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TORSEMIDE, TORSEMIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

TRAVOPROST, TRAVOPROST

URSODIOL, URSODIOL

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

PAR PHARM INC

* PAR PHARMACEUTICAL INC

ACCOLATE, ZAFIRLUKAST

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

TOLCAPONE, TOLCAPONE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

PAR STERILE PRODUCTS

* PAR STERILE PRODUCTS LLC

ADRENALIN, EPINEPHRINE

ARGATROBAN, ARGATROBAN

BREVITAL SODIUM, METHOHEXITAL SODIUM

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

COLY-MYCIN M, COLISTIMETHATE SODIUM

COLY-MYCIN S, COLISTIN SULFATE

B - 115

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PAR STERILE PRODUCTS LLC

DANTRIUM, DANTROLENE SODIUM

DELESTROGEN, ESTRADIOL VALERATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

ETOMIDATE, ETOMIDATE

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

KETALAR, KETAMINE HYDROCHLORIDE

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

PITOCIN, OXYTOCIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIOSTAT, LIOTHYRONINE SODIUM

VASOSTRICT, VASOPRESSIN

PARAGON BIOTECK

* PARAGON BIOTECK INC

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PARAPRO LLC

* PARAPRO LLC

NATROBA, SPINOSAD

PARKE DAVIS

* PARKE DAVIS DIV WARNER LAMBERT CO

CELONTIN, METHSUXIMIDE

CEREBYX, FOSPHENYTOIN SODIUM

DILANTIN, PHENYTOIN SODIUM

DILANTIN-125, PHENYTOIN

NARDIL, PHENELZINE SULFATE

NEURONTIN, GABAPENTIN

ZARONTIN, ETHOSUXIMIDE

* PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO

ZARONTIN, ETHOSUXIMIDE

PEDIAPHARM INC

* PEDIAPHARM INC

NAPROSYN, NAPROXEN

PERNIX IRELAND LTD

* PERNIX IRELAND LTD

TREXIMET, NAPROXEN SODIUM

PERNIX IRELAND PAIN

* PERNIX IRELAND PAIN LIMITED

ZOHYDRO ER, HYDROCODONE BITARTRATE

PERNIX THERAP

* PERNIX THERAPEUTICS LLC

CEDAX, CEFTIBUTEN DIHYDRATE

PERNIX THERAPS LLC

* PERNIX THERAPEUTICS LLC

SILENOR, DOXEPIN HYDROCHLORIDE

PERRIGO

* PERRIGO CO

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CICLOPIROX, CICLOPIROX

CIMETIDINE, CIMETIDINE
(OTC)

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

(OTC)

CLINDETS, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

ERYTHROMYCIN, ERYTHROMYCIN

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE
(OTC)

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

IBUPROFEN, IBUPROFEN
(OTC)

JUNIOR STRENGTH IBUPROFEN, IBUPROFEN

(OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE

(OTC)

MINOXIDIL (FOR MEN), MINOXIDIL

(OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL

(OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

B - 116

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PERRIGO CO

NICOTINE POLACRILEX, NICOTINE POLACRILEX

(OTC)

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

(OTC)

STIE-CORT, HYDROCORTISONE

PERRIGO CO TENNESSEE

* PERRIGO CO TENNESSEE INC

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BACITRACIN, BACITRACIN

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN

ERYTHROMYCIN, ERYTHROMYCIN

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

PERRIGO ISRAEL

* PERRIGO ISRAEL PHARMACEUTICALS

FLUOCINONIDE, FLUOCINONIDE

* PERRIGO ISRAEL PHARMACEUTICALS LTD

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GYNAZOLE-1, BUTOCONAZOLE NITRATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

IMIQUIMOD, IMIQUIMOD

KETOCONAZOLE, KETOCONAZOLE

MESALAMINE, MESALAMINE

MINOXIDIL, MINOXIDIL
(OTC)

NITROGLYCERIN, NITROGLYCERIN

TESTOSTERONE, TESTOSTERONE

PERRIGO NEW YORK

* PERRIGO NEW YORK INC

ACETAMINOPHEN, ACETAMINOPHEN
(OTC)

AMMONIUM LACTATE, AMMONIUM LACTATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CENTANY, MUPIROCIN

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

HYDROCORTISONE, HYDROCORTISONE

KETOCONAZOLE, KETOCONAZOLE

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL

(OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN, NYSTATIN

PERMETHRIN, PERMETHRIN

PERMETHRIN, PERMETHRIN
(OTC)

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SELENIUM SULFIDE, SELENIUM SULFIDE

TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PERRIGO PHARMS CO

* PERRIGO PHARMACEUTICALS CO

SCOPOLAMINE, SCOPOLAMINE

PERRIGO R AND D

* PERRIGO R AND D CO

B - 117

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PERRIGO R AND D CO

CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE

(OTC)

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

DESLORATADINE, DESLORATADINE

GUAIFENESIN, GUAIFENESIN
(OTC)

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE

(OTC)

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, IBUPROFEN

(OTC)

IBUPROFEN SODIUM, IBUPROFEN SODIUM

(OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN
(OTC)

LANSOPRAZOLE, LANSOPRAZOLE
(OTC)

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL, LEVONORGESTREL
(OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE

(OTC)

NAPROXEN, NAPROXEN

NICOTINE POLACRILEX, NICOTINE POLACRILEX

(OTC)

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM

(OTC)

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

(OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

PERRIGO UK FINCO

* PERRIGO UK FINCO LTD PARTNERSHIP

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PETNET

* PETNET SOLUTIONS INC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

PF PRISM CV

* PF PRISM CV

LYRICA, PREGABALIN

RAPAMUNE, SIROLIMUS

TORISEL, TEMSIROLIMUS

TYGACIL, TIGECYCLINE

VFEND, VORICONAZOLE

XALKORI, CRIZOTINIB

XELJANZ, TOFACITINIB CITRATE

ZMAX, AZITHROMYCIN

PFIZER

* PFIZER CENTRAL RESEARCH

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER CHEMICALS DIV PFIZER INC

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER INC

ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE

(OTC)

ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE

(OTC)

ADVIL COLD AND SINUS, IBUPROFEN

(OTC)

ADVIL CONGESTION RELIEF, IBUPROFEN

(OTC)

ADVIL LIQUI-GELS, IBUPROFEN

(OTC)

ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN

(OTC)

ADVIL PM, DIPHENHYDRAMINE CITRATE

(OTC)

ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE

(OTC)

ADVIL, IBUPROFEN
(OTC)

ALAVERT, LORATADINE
(OTC)

ARGATROBAN, ARGATROBAN

AXID AR, NIZATIDINE

(OTC)

CADUET, AMLODIPINE BESYLATE

B - 118

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PFIZER INC

CALAN SR, VERAPAMIL HYDROCHLORIDE

CARDURA XL, DOXAZOSIN MESYLATE

CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE

(OTC)

CHILDREN'S ADVIL COLD, IBUPROFEN

(OTC)

CHILDREN'S ADVIL, IBUPROFEN

(OTC)

CHILDREN'S ADVIL-FLAVORED, IBUPROFEN

(OTC)

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

ELELYSO, TALIGLUCERASE ALFA

GEODON, ZIPRASIDONE HYDROCHLORIDE

GEODON, ZIPRASIDONE MESYLATE

GLUCOTROL XL, GLIPIZIDE

GLUCOTROL, GLIPIZIDE

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

INLYTA, AXITINIB

JUNIOR STRENGTH ADVIL, IBUPROFEN

(OTC)

LIPITOR, ATORVASTATIN CALCIUM

LORATADINE, LORATADINE
(OTC)

NAVANE, THIOTHIXENE

NORVASC, AMLODIPINE BESYLATE

PEDIATRIC ADVIL, IBUPROFEN

(OTC)

PROCARDIA, NIFEDIPINE

REVATIO, SILDENAFIL CITRATE

SONATA, ZALEPLON

TESSALON, BENZONATATE

TOVIAZ, FESOTERODINE FUMARATE

UNASYN, AMPICILLIN SODIUM

ZITHROMAX, AZITHROMYCIN

* PFIZER LABORATORIES DIV PFIZER INC

CARDURA, DOXAZOSIN MESYLATE

DIABINESE, CHLORPROPAMIDE

FELDENE, PIROXICAM

MINIPRESS, PRAZOSIN HYDROCHLORIDE

PERMAPEN, PENICILLIN G BENZATHINE

PFIZERPEN, PENICILLIN G POTASSIUM

PROCARDIA XL, NIFEDIPINE

TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE

UNASYN, AMPICILLIN SODIUM

VIBRAMYCIN, DOXYCYCLINE

VIBRAMYCIN, DOXYCYCLINE CALCIUM

VIBRAMYCIN, DOXYCYCLINE HYCLATE

VISTARIL, HYDROXYZINE PAMOATE

* PFIZER PHARMACEUTICALS INC

ZOLOFT, SERTRALINE HYDROCHLORIDE

* PFIZER PHARMACEUTICALS PRODUCTION CORP LTD

TIKOSYN, DOFETILIDE

PFIZER CONS HLTHCARE

* PFIZER CONSUMER HEALTHCARE

ADVIL, IBUPROFEN SODIUM

(OTC)

PFIZER INC

* PFIZER INC

CAMPTOSAR, IRINOTECAN HYDROCHLORIDE

CHANTIX, VARENICLINE TARTRATE

ELLENCE, EPIRUBICIN HYDROCHLORIDE

FRAGMIN, DALTEPARIN SODIUM

IBRANCE, PALBOCICLIB

NICOTROL, NICOTINE

QUILLICHEW ER, METHYLPHENIDATE HYDROCHLORIDE

PFIZER IRELAND

* PFIZER IRELAND PHARMACEUTICALS

RELPAX, ELETRIPTAN HYDROBROMIDE

VIAGRA, SILDENAFIL CITRATE

B - 119

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

PFIZER LABS

* PFIZER LABS

DOCETAXEL, DOCETAXEL

PFIZER PHARMS

* PFIZER PHARMACEUTICALS LTD

ACCUPRIL, QUINAPRIL HYDROCHLORIDE

ACCURETIC, HYDROCHLOROTHIAZIDE

DILANTIN, PHENYTOIN

LOPID, GEMFIBROZIL

NEURONTIN, GABAPENTIN

NITROSTAT, NITROGLYCERIN

PHARM ASSOC

* PHARMACEUTICAL ASSOC INC

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LORAZEPAM, LORAZEPAM

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

* PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

LACTULOSE, LACTULOSE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

NYSTATIN, NYSTATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PREDNISOLONE, PREDNISOLONE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

* PHARMACEUTICAL ASSOCIATES INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LEVETIRACETAM, LEVETIRACETAM

PHARMA RES SOFTWARE

* PHARMA RESEARCH SOFTWARE SOLUTION LLC

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PHARMA-MED INC

* PHARMA-MED INC

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PHARMACEUTICS

* PHARMACEUTICS INTERNATIONAL INC

ZOLEDRONIC ACID, ZOLEDRONIC ACID

PHARMACEUTICS INTL

* PHARMACEUTICS INTERNATIONAL INC

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PHARMACHEMIE BV

* PHARMACHEMIE BV

CARBOPLATIN, CARBOPLATIN

CISPLATIN, CISPLATIN

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

PHARMACIA AND UPJOHN

* PHARMACIA AND UPJOHN

XANAX XR, ALPRAZOLAM

* PHARMACIA AND UPJOHN CO

AROMASIN, EXEMESTANE

AZULFIDINE EN-TABS, SULFASALAZINE

AZULFIDINE, SULFASALAZINE

BACITRACIN, BACITRACIN

B - 120

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PHARMACIA AND UPJOHN CO

CAVERJECT IMPULSE, ALPROSTADIL

CAVERJECT, ALPROSTADIL

CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLEOCIN T, CLINDAMYCIN PHOSPHATE

CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLEOCIN, CLINDAMYCIN PHOSPHATE

COLESTID, COLESTIPOL HYDROCHLORIDE

CORTEF, HYDROCORTISONE

CORVERT, IBUTILIDE FUMARATE

CYKLOKAPRON, TRANEXAMIC ACID

DEPO-ESTRADIOL, ESTRADIOL CYPIONATE

DEPO-MEDROL, METHYLPREDNISOLONE ACETATE

DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE

DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE

DETROL LA, TOLTERODINE TARTRATE

DETROL, TOLTERODINE TARTRATE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM

ESTRING, ESTRADIOL

FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE

GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT

GENOTROPIN, SOMATROPIN RECOMBINANT

GLYNASE, GLYBURIDE

GLYSET, MIGLITOL

HALCION, TRIAZOLAM

HEMABATE, CARBOPROST TROMETHAMINE

IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE

LINCOCIN, LINCOMYCIN HYDROCHLORIDE

MEDROL, METHYLPREDNISOLONE

MYCOBUTIN, RIFABUTIN

NICOTROL, NICOTINE

OGEN .625, ESTROPIPATE

OGEN 1.25, ESTROPIPATE

OGEN 2.5, ESTROPIPATE

OGEN 5, ESTROPIPATE

PREPIDIL, DINOPROSTONE

PROSTIN E2, DINOPROSTONE

PROSTIN VR PEDIATRIC, ALPROSTADIL

PROVERA, MEDROXYPROGESTERONE ACETATE

R-GENE 10, ARGININE HYDROCHLORIDE

SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE

SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE

SOMAVERT, PEGVISOMANT

XALATAN, LATANOPROST

XANAX, ALPRAZOLAM

ZINECARD, DEXRAZOXANE HYDROCHLORIDE

ZYVOX, LINEZOLID

* PHARMACIA AND UPJOHN SUB PFIZER INC

DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE

PHARMACYCLICS INC

* PHARMACYCLICS INC

IMBRUVICA, IBRUTINIB

PHARMADAX INC

* PHARMADAX INC

LEVETIRACETAM, LEVETIRACETAM

PHARMAFORCE

* PHARMAFORCE INC

BUSULFAN, BUSULFAN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

NANDROLONE DECANOATE, NANDROLONE DECANOATE

PHARMALUCENCE

* PHARMALUCENCE INC

B - 121

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PHARMALUCENCE INC

AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT

CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT

CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT

HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

PHARMAX

* PHARMAX GROUP INC

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

PHARMS

* PHARMACEUTICALS INTERNATIONAL

ZOLEDRONIC ACID, ZOLEDRONIC ACID

PHOTOCURE ASA

* PHOTOCURE ASA

CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE

PIERRE FABRE

* PIERRE FABRE MEDICAMENT

NAVELBINE, VINORELBINE TARTRATE

PIERRE FABRE DERMA

* PIERRE FABRE DERMATOLOGIE

HEMANGEOL, PROPRANOLOL HYDROCHLORIDE

PIERREL

* PIERREL S.P.A.

ORABLOC, ARTICAINE HYDROCHLORIDE

PIRAMAL CRITICAL

* PIRAMAL CRITICAL CARE INC

ENFLURANE, ENFLURANE

ISOFLURANE, ISOFLURANE

SOJOURN, SEVOFLURANE

PIRAMAL ENT

* PIRAMAL ENTERPRISES LTD

ISOFLURANE, ISOFLURANE

PIRAMAL IMAGING

* PIRAMAL IMAGING SA

NEURACEQ, FLORBETABEN F-18

PLIVA

* PLIVA INC

AZITHROMYCIN, AZITHROMYCIN

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CIMETIDINE, CIMETIDINE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

METRONIDAZOLE, METRONIDAZOLE

NAPROXEN, NAPROXEN

PENTOXIFYLLINE, PENTOXIFYLLINE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

WARFARIN SODIUM, WARFARIN SODIUM

PLIVA HRVATSKA DOO

* PLIVA HRVATSKA DOO

ADAPALENE, ADAPALENE

CARVEDILOL, CARVEDILOL

CILOSTAZOL, CILOSTAZOL

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

B - 122

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

PLIVA LACHEMA

* PLIVA LACHEMA AS

CARBOPLATIN, CARBOPLATIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PLIVA PHARM IND

* PLIVA PHARMACEUTICAL INDUSTRY INC

TORSEMIDE, TORSEMIDE

PLX PHARMA

* PLX PHARMA INC

ASPIRIN, ASPIRIN
(OTC)

POHL BOSKAMP

* POHL BOSKAMP

NITROLINGUAL PUMPSPRAY, NITROGLYCERIN

POLYMEDICA

* POLYMEDICA INDUSTRIES INC

NEOPAP, ACETAMINOPHEN
(OTC)

POWDER PHARMS

* POWDER PHARMACEUTICALS INC

ZINGO, LIDOCAINE HYDROCHLORIDE

PRAGMA PHARMS LLC

* PRAGMA PHARMACEUTICALS LLC

MOXATAG, AMOXICILLIN

PRECISION DERMAT

* PRECISION DERMATOLOGY INC

CLINDAGEL, CLINDAMYCIN PHOSPHATE

LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE

LOCOID, HYDROCORTISONE BUTYRATE

MINOCIN, MINOCYCLINE HYDROCHLORIDE

PRECISION DOSE

* PRECISION DOSE INC

RISPERIDONE, RISPERIDONE

PRECISION NUCLEAR

* PRECISION NUCLEAR LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

PRINSTON INC

* PRINSTON PHARMACEUTICAL INC

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METHOCARBAMOL, METHOCARBAMOL

NEVIRAPINE, NEVIRAPINE

PAROXETINE, PAROXETINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

VALSARTAN, VALSARTAN

PROCTER AND GAMBLE

* PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO

DIDRONEL, ETIDRONATE DISODIUM

PROF DSPLS

* PROFESSIONAL DISPOSABLES INC

PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE

(OTC)

PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE

(OTC)

PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE

(OTC)

PROMETHEUS LABS

B - 123

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PROMETHEUS LABORATORIES INC

IMURAN, AZATHIOPRINE

LOTRONEX, ALOSETRON HYDROCHLORIDE

MERCAPTOPURINE, MERCAPTOPURINE

RIDAURA, AURANOFIN

ZYLOPRIM, ALLOPURINOL

PROMIUS PHARMA

* PROMIUS PHARMA LLC

SECTRAL, ACEBUTOLOL HYDROCHLORIDE

TENEX, GUANFACINE HYDROCHLORIDE

PROMIUS PHARMA LLC

* PROMIUS PHARMA LLC

CLODERM, CLOCORTOLONE PIVALATE

PROSAM LABS

* PROSAM LABS LLC

BACLOFEN, BACLOFEN

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARISOPRODOL AND ASPIRIN, ASPIRIN

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

RIMACTANE, RIFAMPIN

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

PROSTRAKAN INC

* PROSTRAKAN INC

FARESTON, TOREMIFENE CITRATE

SANCUSO, GRANISETRON

PROVENSIS

* PROVENSIS LTD

VARITHENA, POLIDOCANOL

PROVIDENT PHARM

* PROVIDENT PHARMACEUTICAL INC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PULMOFLOW INC

* PULMOFLOW INC

KITABIS PAK, TOBRAMYCIN

PULSION MEDCL

* PULSION MEDICAL SYSTEMS AG

INDOCYANINE GREEN, INDOCYANINE GREEN

PURACAP PHARM

* PURACAP PHARMACEUTICAL LLC

MELOXICAM, MELOXICAM

PURACAP PHARM LLC

* PURACAP PHARMACEUTICAL LLC

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

PURDUE GMP

* PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY

SEROMYCIN, CYCLOSERINE

PURDUE PHARM PRODS

* PURDUE PHARMACEUTICAL PRODUCTS LP

DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE

PURDUE PHARMA

* PURDUE PHARMA PRODUCTS LP

INTERMEZZO, ZOLPIDEM TARTRATE

PURDUE PHARMA LP

* PURDUE PHARMA LP

BUTRANS, BUPRENORPHINE

HYSINGLA, HYDROCODONE BITARTRATE

MS CONTIN, MORPHINE SULFATE

OXYCONTIN, OXYCODONE HYDROCHLORIDE

PUREPAC PHARM

B - 124

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

**

**

* PUREPAC PHARMACEUTICAL CO

DIPYRIDAMOLE, DIPYRIDAMOLE

QILU PHARM CO LTD

* QILU PHARMACEUTICAL CO LTD

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

QOL MEDCL

* QOL MEDICAL LLC

ETHAMOLIN, ETHANOLAMINE OLEATE

SUCRAID, SACROSIDASE

QUEEN HAMAMATSU PET

* QUEEN HAMAMATSU PET IMAGING CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

**

**

R-PHARM US LLC

* R-PHARM US LLC

IXEMPRA KIT, IXABEPILONE

R-TECH UENO LTD

* R-TECH UENO LTD

RESCULA, UNOPROSTONE ISOPROPYL

RANBAXY

* RANBAXY INC

ABSORICA, ISOTRETINOIN

* RANBAXY LABORATORIES INC

EURAX, CROTAMITON

EXELDERM, SULCONAZOLE NITRATE

HALOG, HALCINONIDE

LAC-HYDRIN, AMMONIUM LACTATE

ULTRAVATE, HALOBETASOL PROPIONATE

* RANBAXY LABORATORIES LTD

ACYCLOVIR, ACYCLOVIR

RAPTOR INC

* RAPTOR PHARMACEUTICALS INC

PROCYSBI, CYSTEAMINE BITARTRATE

RARE DIS THERAP

* RARE DISEASE THERAPEUTICS INC

CYSTADANE, BETAINE HYDROCHLORIDE

RARITAN PHARMS INC

* RARITAN PHARMACEUTICALS INC

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

RECIP

* RECIP AB

THYROSAFE, POTASSIUM IODIDE

(OTC)

RECKITT BENCKISER

* RECKITT BENCKISER LLC

DELSYM, DEXTROMETHORPHAN POLISTIREX

(OTC)

MUCINEX D, GUAIFENESIN
(OTC)

MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE

(OTC)

MUCINEX, GUAIFENESIN
(OTC)

RECORDATI RARE

* RECORDATI RARE DISEASES INC

CHEMET, SUCCIMER

COSMEGEN, DACTINOMYCIN

DESOXYN, METHAMPHETAMINE HYDROCHLORIDE

INDOCIN, INDOMETHACIN SODIUM

MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE

NEOPROFEN, IBUPROFEN LYSINE

PEGANONE, ETHOTOIN

TRANXENE, CLORAZEPATE DIPOTASSIUM

RECRO GAINESVILLE

* RECRO GAINESVILLE LLC

(OTC)

B - 125

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APPENDIX B

B - 126

PRODUCT NAME SORTED BY APPLICANT

**

**

* RECRO GAINESVILLE LLC

VERELAN PM, VERAPAMIL HYDROCHLORIDE

VERELAN, VERAPAMIL HYDROCHLORIDE

RELYPSA INC

* RELYPSA INC

VELTASSA, PATIROMER SORBITEX CALCIUM

REMPEX PHARMS INC

* REMPEX PHARMACEUTICALS INC

MINOCIN, MINOCYCLINE HYDROCHLORIDE

RENAISSANCE PHARMA

* RENAISSANCE PHARMA US HOLDINGS INC

ELIMITE, PERMETHRIN

RHODES PHARMS

* RHODES PHARMACEUTICALS LP

APTENSIO XR, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

UNIPHYL, THEOPHYLLINE

RICONPHARMA LLC

* RICONPHARMA LLC

GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

QUININE SULFATE, QUININE SULFATE

RISING PHARMS INC

* RISING PHARMACEUTICALS INC

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

HYDROCORTISONE, HYDROCORTISONE

PARICALCITOL, PARICALCITOL

ROCHE PALO

* ROCHE PALO ALTO LLC

CELLCEPT, MYCOPHENOLATE MOFETIL

CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

CYTOVENE, GANCICLOVIR SODIUM

EC-NAPROSYN, NAPROXEN

NAPROSYN, NAPROXEN

ROCKWELL MEDCL

* ROCKWELL MEDICAL TECHNOLOGIES INC

CALCITRIOL, CALCITRIOL

ROCKWELL MEDICAL INC

* ROCKWELL MEDICAL INC

TRIFERIC, FERRIC PYROPHOSPHATE CITRATE

ROMARK

* ROMARK LABORATORIES

ALINIA, NITAZOXANIDE

ROSEDALE THERAPEUTIC

* ROSEDALE THERAPEUTICS

ERGOMAR, ERGOTAMINE TARTRATE

ROUSES POINT PHARMS

* ROUSES POINT PHARMACEUTICALS LLC

LEVETIRACETAM, LEVETIRACETAM

ROXANE

* ROXANE LABORATORIES INC

ACARBOSE, ACARBOSE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ROXANE LABORATORIES INC

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CALCITRIOL, CALCITRIOL

CALCIUM ACETATE, CALCIUM ACETATE

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CILOSTAZOL, CILOSTAZOL

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLARITHROMYCIN, CLARITHROMYCIN

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOTRIMAZOLE, CLOTRIMAZOLE

CODEINE SULFATE, CODEINE SULFATE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DEXAMETHASONE INTENSOL, DEXAMETHASONE

DEXAMETHASONE, DEXAMETHASONE

DIAZEPAM INTENSOL, DIAZEPAM

DIAZEPAM, DIAZEPAM

DIGOXIN, DIGOXIN

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DISULFIRAM, DISULFIRAM

DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DUTASTERIDE, DUTASTERIDE

ESZOPICLONE, ESZOPICLONE

EXEMESTANE, EXEMESTANE

FAMCICLOVIR, FAMCICLOVIR

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUCONAZOLE, FLUCONAZOLE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

FUROSEMIDE, FUROSEMIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LACTULOSE, LACTULOSE

LETROZOLE, LETROZOLE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE

LINEZOLID, LINEZOLID

LITHIUM CARBONATE, LITHIUM CARBONATE

LITHIUM CITRATE, LITHIUM CITRATE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

LORAZEPAM INTENSOL, LORAZEPAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MERCAPTOPURINE, MERCAPTOPURINE

METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MORPHINE SULFATE, MORPHINE SULFATE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NAPROXEN, NAPROXEN

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

B - 127

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ROXANE LABORATORIES INC

OXCARBAZEPINE, OXCARBAZEPINE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PREDNISONE INTENSOL, PREDNISONE

PREDNISONE, PREDNISONE

PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RAMIPRIL, RAMIPRIL

RISPERIDONE, RISPERIDONE

RITONAVIR, RITONAVIR

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ROXICET, ACETAMINOPHEN

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

TINIDAZOLE, TINIDAZOLE

TORSEMIDE, TORSEMIDE

TRIAZOLAM, TRIAZOLAM

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

ZALEPLON, ZALEPLON

ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

RP SCHERER

* RP SCHERER TECHNOLOGIES LLC

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

RTRX

* RETROPHIN INC

CHOLBAM, CHOLIC ACID

RUBICON RES PVT LTD

* RUBICON RESEARCH PVT LTD

METOPROLOL TARTRATE, METOPROLOL TARTRATE

**

**

SAGE PRODS

* SAGE PRODUCTS INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

(OTC)

SAGENT AGILA

* SAGENT AGILA LLC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SAGENT PHARMS

* SAGENT PHARMACEUTICALS INC

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

CAFFEINE CITRATE, CAFFEINE CITRATE

CARBOPLATIN, CARBOPLATIN

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

FLUMAZENIL, FLUMAZENIL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLYDO, LIDOCAINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

B - 128

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SAGENT PHARMACEUTICALS INC

IBANDRONATE SODIUM, IBANDRONATE SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

MESNA, MESNA

NAFCILLIN SODIUM, NAFCILLIN SODIUM

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXACILLIN SODIUM, OXACILLIN SODIUM

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

SAGENT STRIDES

* SAGENT STRIDES LLC

ADENOSINE, ADENOSINE

AZITHROMYCIN, AZITHROMYCIN

BACITRACIN, BACITRACIN

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

POLYMYCIN B SULFATE, POLYMYXIN B SULFATE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SALIX PHARMS

* SALIX PHARMACEUTICALS INC

ANUSOL HC, HYDROCORTISONE

DIURIL, CHLOROTHIAZIDE

FULYZAQ, CROFELEMER

METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE

MOVIPREP, ASCORBIC ACID

OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

PEPCID, FAMOTIDINE

RELISTOR, METHYLNALTREXONE BROMIDE

XIFAXAN, RIFAXIMIN

SAMSON MEDCL

* SAMSON MEDICAL TECHNOLOGIES LLC

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFOXITIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

SANDOZ

* SANDOZ

DOCETAXEL, DOCETAXEL

* SANDOZ CANADA INC

ANECTINE, SUCCINYLCHOLINE CHLORIDE

ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

DIGOXIN, DIGOXIN

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FLUMAZENIL, FLUMAZENIL

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID

INFUVITE PEDIATRIC, ASCORBIC ACID

ISONIAZID, ISONIAZID

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

B - 129

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 130

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANDOZ CANADA INC

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

REGONOL, PYRIDOSTIGMINE BROMIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

* SANDOZ INC

ALPRAZOLAM, ALPRAZOLAM

ALTAVERA, ETHINYL ESTRADIOL

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

ANASTROZOLE, ANASTROZOLE

APREPITANT, APREPITANT

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

ATENOLOL, ATENOLOL

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BUMETANIDE, BUMETANIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CAFERGOT, CAFFEINE

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CAPTOPRIL, CAPTOPRIL

CARISOPRODOL AND ASPIRIN, ASPIRIN

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CILOSTAZOL, CILOSTAZOL

CLARITHROMYCIN, CLARITHROMYCIN

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

(OTC)

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

COSYNTROPIN, COSYNTROPIN

CYCLOSPORINE, CYCLOSPORINE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DESLORATADINE, DESLORATADINE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANDOZ INC

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

EPLERENONE, EPLERENONE

ESTARYLLA, ETHINYL ESTRADIOL

ETODOLAC, ETODOLAC

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUOROURACIL, FLUOROURACIL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE, GLIPIZIDE

HALOPERIDOL, HALOPERIDOL

HEPARIN SODIUM, HEPARIN SODIUM

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

INTROVALE, ETHINYL ESTRADIOL

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

ISONIAZID, ISONIAZID

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ITRACONAZOLE, ITRACONAZOLE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LANSOPRAZOLE, LANSOPRAZOLE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVOFLOXACIN, LEVOFLOXACIN

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LONOX, ATROPINE SULFATE

LORATADINE, LORATADINE
(OTC)

LORAZEPAM, LORAZEPAM

LORYNA, DROSPIRENONE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOVASTATIN, LOVASTATIN

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEROPENEM, MEROPENEM

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

METHIMAZOLE, METHIMAZOLE

METHOCARBAMOL, METHOCARBAMOL

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

NAFCILLIN SODIUM, NAFCILLIN SODIUM

NAPROXEN, NAPROXEN

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

B - 131

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANDOZ INC

NIZATIDINE, NIZATIDINE

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OMEPRAZOLE, OMEPRAZOLE

OMNITROPE, SOMATROPIN RECOMBINANT

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXACILLIN SODIUM, OXACILLIN SODIUM

OXALIPLATIN, OXALIPLATIN

OXAPROZIN, OXAPROZIN

OXAZEPAM, OXAZEPAM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PENICILLIN G SODIUM, PENICILLIN G SODIUM

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PERPHENAZINE, PERPHENAZINE

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUINIDINE SULFATE, QUINIDINE SULFATE

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RESERPINE, RESERPINE

RIBAVIRIN, RIBAVIRIN

RIFAMPIN, RIFAMPIN

RISPERIDONE, RISPERIDONE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SPIRONOLACTONE, SPIRONOLACTONE

SULFADIAZINE, SULFADIAZINE

SYEDA, DROSPIRENONE

TACROLIMUS, TACROLIMUS

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TEMAZEPAM, TEMAZEPAM

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

THIOTHIXENE, THIOTHIXENE

TRI-ESTARYLLA, ETHINYL ESTRADIOL

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SANDOZ CANADA INC

* SANDOZ CANADA INC

PARICALCITOL, PARICALCITOL

SANDOZ INC

* SANDOZ INC

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BUDESONIDE, BUDESONIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CEFTRIAXONE, CEFTRIAXONE SODIUM

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

B - 132

B - 133

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANDOZ INC

DECITABINE, DECITABINE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

ELIFEMME, ETHINYL ESTRADIOL

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

GLATOPA, GLATIRAMER ACETATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

ISIBLOOM, DESOGESTREL

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

LINEZOLID, LINEZOLID

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NEVIRAPINE, NEVIRAPINE

OLANZAPINE, OLANZAPINE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

REPAGLINIDE, REPAGLINIDE

RIBAVIRIN, RIBAVIRIN

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

TELMISARTAN, TELMISARTAN

TIGECYCLINE, TIGECYCLINE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRI-LO-ESTARYLLA, ETHINYL ESTRADIOL

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VIENVA, ETHINYL ESTRADIOL

VORICONAZOLE, VORICONAZOLE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

SANOFI AVENTIS

* SANOFI AVENTIS

AFREZZA, INSULIN RECOMBINANT HUMAN

SANOFI AVENTIS US

* SANOFI AVENTIS US INC

JEVTANA KIT, CABAZITAXEL

* SANOFI AVENTIS US LLC

ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

ALLEGRA, FEXOFENADINE HYDROCHLORIDE

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE
AMARYL, GLIMEPIRIDE

AMBIEN CR, ZOLPIDEM TARTRATE

AMBIEN, ZOLPIDEM TARTRATE

ANZEMET, DOLASETRON MESYLATE

APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT

APIDRA, INSULIN GLULISINE RECOMBINANT

ARALEN, CHLOROQUINE PHOSPHATE

ARAVA, LEFLUNOMIDE

AUBAGIO, TERIFLUNOMIDE

AUVI-Q, EPINEPHRINE

AVALIDE, HYDROCHLOROTHIAZIDE

AVAPRO, IRBESARTAN

CANTIL, MEPENZOLATE BROMIDE

CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM

CLAFORAN, CEFOTAXIME SODIUM

(OTC)

(OTC)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANOFI AVENTIS US LLC

CLOMID, CLOMIPHENE CITRATE

DEMEROL, MEPERIDINE HYDROCHLORIDE

DIABETA, GLYBURIDE

DRISDOL, ERGOCALCIFEROL

ELOXATIN, OXALIPLATIN

FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX

GAVISCON, ALUMINUM HYDROXIDE

(OTC)

HIPREX, METHENAMINE HIPPURATE

KETEK, TELITHROMYCIN

LANTUS SOLOSTAR, INSULIN GLARGINE RECOMBINANT

LANTUS, INSULIN GLARGINE RECOMBINANT

LASIX, FUROSEMIDE

LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM

LOVENOX, ENOXAPARIN SODIUM

MULTAQ, DRONEDARONE HYDROCHLORIDE

NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE

(OTC)

NICODERM CQ, NICOTINE

(OTC)

NORPRAMIN, DESIPRAMINE HYDROCHLORIDE

PHISOHEX, HEXACHLOROPHENE

PLAVIX, CLOPIDOGREL BISULFATE

PRIFTIN, RIFAPENTINE

PRIMAQUINE, PRIMAQUINE PHOSPHATE

RIFADIN, RIFAMPIN

RIFAMATE, ISONIAZID

RIFATER, ISONIAZID

TAXOTERE, DOCETAXEL

SANOFI PASTEUR INC

* SANOFI PASTEUR INC

SKLICE, IVERMECTIN

SANOFI US SERVICES

* SANOFI US SERVICES INC

TOUJEO SOLOSTAR, INSULIN GLARGINE RECOMBINANT

SANTARUS INC

* SANTARUS INC

FENOGLIDE, FENOFIBRATE

GLUMETZA, METFORMIN HYDROCHLORIDE

ZEGERID, OMEPRAZOLE

SANTOS BIOTECH

* SANTOS BIOTECH INDUSTRIES INC

ANASTROZOLE, ANASTROZOLE

SB PHARMCO

* SB PHARMCO PUERTO RICO INC

AVANDIA, ROSIGLITAZONE MALEATE

COREG CR, CARVEDILOL PHOSPHATE

SCHERING

* SCHERING CORP

INTEGRILIN, EPTIFIBATIDE

NOXAFIL, POSACONAZOLE

REBETOL, RIBAVIRIN

SCHERING PLOUGH

* SCHERING PLOUGH HEALTHCARE PRODUCTS INC

AFRINOL, PSEUDOEPHEDRINE SULFATE

(OTC)

SCIEGEN PHARMS INC

* SCIEGEN PHARMACEUTICALS INC

CARISOPRODOL, CARISOPRODOL

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

B - 134

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SCIEGEN PHARMACEUTICALS INC

NEVIRAPINE, NEVIRAPINE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

SCIOS LLC

* SCIOS LLC

NATRECOR, NESIRITIDE RECOMBINANT

SEBELA IRELAND LTD

* SEBELA IRELAND LTD

MICORT-HC, HYDROCORTISONE ACETATE

MOTOFEN, ATROPINE SULFATE

PRAMOSONE, HYDROCORTISONE ACETATE

SECAN PHARMS

* SECAN PHARMACEUTICALS INC

LEVETIRACETAM, LEVETIRACETAM

SENTYNL THERAPS INC

* SENTYNL THERAPEUTICS INC

ABSTRAL, FENTANYL CITRATE

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

SEPTODONT

* SEPTODONT INC

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

OCTOCAINE, EPINEPHRINE

SEPTODONT HOLDING

* SEPTODONT HOLDING SAS

ORAVERSE, PHENTOLAMINE MESYLATE

SEPTODONT INC

* SEPTODONT INC

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE

PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE

SERB SAS

* SERB SAS

CYANOKIT, HYDROXOCOBALAMIN

SETON PHARM

* SETON PHARMACEUTICAL LLC

PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE

SHANGHAI HENGRUI

* SHANGHAI HENGRUI PHARMACEUTICAL CO LTD

SEVOFLURANE, SEVOFLURANE

SHASUN CHEMS

* SHASUN CHEMICALS AND DRUGS LTD

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

SHASUN PHARMS LTD

* SHASUN PHARMACEUTICALS LTD

CARISOPRODOL, CARISOPRODOL

SHASUN USA

* SHASUN USA INC

IBUPROFEN, IBUPROFEN

SHENZHEN TECHDOW

* SHENZHEN TECHDOW PHARMACEUTICAL CO LTD

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

SHERTECH LABS LLC

* SHERTECH LABORATORIES LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

SHIONOGI INC

* SHIONOGI INC

DORIBAX, DORIPENEM

FURADANTIN, NITROFURANTOIN

KEFLEX, CEPHALEXIN

OSPHENA, OSPEMIFENE

PONSTEL, MEFENAMIC ACID

ROBINUL FORTE, GLYCOPYRROLATE

B - 135

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SHIONOGI INC

ROBINUL, GLYCOPYRROLATE

SULAR, NISOLDIPINE

ULESFIA, BENZYL ALCOHOL

SHIRE

* SHIRE DEVELOPMENT INC

ADDERALL XR 10, AMPHETAMINE ASPARTATE

ADDERALL XR 15, AMPHETAMINE ASPARTATE

ADDERALL XR 20, AMPHETAMINE ASPARTATE

ADDERALL XR 25, AMPHETAMINE ASPARTATE

ADDERALL XR 30, AMPHETAMINE ASPARTATE

ADDERALL XR 5, AMPHETAMINE ASPARTATE

CARBATROL, CARBAMAZEPINE

INTUNIV, GUANFACINE HYDROCHLORIDE

LIALDA, MESALAMINE

PENTASA, MESALAMINE

SHIRE DEV LLC

* SHIRE DEVELOPMENT LLC

FOSRENOL, LANTHANUM CARBONATE

SHIRE DEVELOPMENT

* SHIRE DEVELOPMENT INC

VYVANSE, LISDEXAMFETAMINE DIMESYLATE

SHIRE HUMAN GENETIC

* SHIRE HUMAN GENETIC THERAPIES INC

VPRIV, VELAGLUCERASE ALFA

SHIRE LLC

* SHIRE DEVELOPMENT LLC

AGRYLIN, ANAGRELIDE HYDROCHLORIDE

FOSRENOL, LANTHANUM CARBONATE

SALURON, HYDROFLUMETHIAZIDE

SHIRE ORPHAN THERAP

* SHIRE ORPHAN THERAPIES INC

FIRAZYR, ICATIBANT ACETATE

SIDMAK LABS INDIA

* SIDMAK LABORATORIES INDIA PVT LTD

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

SIGMA TAU

* SIGMA TAU PHARMACEUTICALS INC

ABELCET, AMPHOTERICIN B

ADAGEN, PEGADEMASE BOVINE

CARNITOR SF, LEVOCARNITINE

CARNITOR, LEVOCARNITINE

CYSTARAN, CYSTEAMINE HYDROCHLORIDE

MATULANE, PROCARBAZINE HYDROCHLORIDE

SIGMAPHARM LABS LLC

* SIGMAPHARM LABORATORIES LLC

ACITRETIN, ACITRETIN

ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

DISULFIRAM, DISULFIRAM

ERGOCALCIFEROL, ERGOCALCIFEROL

FLUCYTOSINE, FLUCYTOSINE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

SILARX

* SILARX PHARMACEUTICALS INC

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

B - 136

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SILARX PHARMACEUTICALS INC

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

LEVETIRACETAM, LEVETIRACETAM

LORATADINE, LORATADINE
(OTC)

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

SILARX PHARMS INC

* SILARX PHARMACEUTICALS INC

ARIPIPRAZOLE, ARIPIPRAZOLE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LAMIVUDINE, LAMIVUDINE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SILVERGATE PHARMS

* SILVERGATE PHARMACEUTICALS INC

EPANED KIT, ENALAPRIL MALEATE

SKINMEDICA

* SKINMEDICA INC

VANIQA, EFLORNITHINE HYDROCHLORIDE

SKYEPHARMA AG

* SKYEPHARMA AG

TRIGLIDE, FENOFIBRATE

SMITHKLINE BEECHAM

* SMITHKLINE BEECHAM

LOVAZA, OMEGA-3-ACID ETHYL ESTERS

* SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE

COREG, CARVEDILOL

SOAPCO

* SOAPCO INC

BRIAN CARE, CHLORHEXIDINE GLUCONATE

(OTC)

SOFGEN PHARMS

* SOFGEN PHARMACEUTICALS

NIMODIPINE, NIMODIPINE

* SOFGEN PHARMACEUTICALS LLC

PROGESTERONE, PROGESTERONE

SOMERSET

* SOMERSET PHARMACEUTICALS INC

ELDEPRYL, SELEGILINE HYDROCHLORIDE

EMSAM, SELEGILINE

SOVEREIGN PHARMS

* SOVEREIGN PHARMACEUTICALS LLC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

OBREDON, GUAIFENESIN

SPEAR PHARMS

* SPEAR PHARMACEUTICALS INC

FLUOROURACIL, FLUOROURACIL

SPEAR PHARMS INC

* SPEAR PHARMACEUTICALS INC

FLUOROURACIL, FLUOROURACIL

TRETINOIN, TRETINOIN

SPECTRON MRC LLC

* SPECTRON MRC LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

SPECTRUM PHARMS

* SPECTRUM PHARMACEUTICALS INC

BELEODAQ, BELINOSTAT

B - 137

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 138

PRODUCT NAME SORTED BY APPLICANT

**

**

* SPECTRUM PHARMACEUTICALS INC

FUSILEV, LEVOLEUCOVORIN CALCIUM

SPRIASO LLC

* SPRIASO LLC

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE

SPROUT PHARMS

* SPROUT PHARMACEUTICALS INC

ADDYI, FLIBANSERIN

STAND HOMEOPATH

* STANDARD HOMEOPATHIC CO

IVY BLOCK, BENTOQUATAM

(OTC)

STANDARD CHEM PHARM

* STANDARD CHEM AND PHARM CO LTD

REPAGLINIDE, REPAGLINIDE

STASON

* STASON INDUSTRIAL CORP

ACYCLOVIR, ACYCLOVIR

CAPTOPRIL, CAPTOPRIL

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

STASON PHARMS

* STASON PHARMACEUTICALS INC

BICALUTAMIDE, BICALUTAMIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

STI PHARMA LLC

* STI PHARMA LLC

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

DEXAMETHASONE, DEXAMETHASONE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE

SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

TRIACIN-C, CODEINE PHOSPHATE

STIEFEL

* STIEFEL LABORATORIES INC

DUAC, BENZOYL PEROXIDE

STIEFEL GSK

* STIEFEL A GSK CO

VELTIN, CLINDAMYCIN PHOSPHATE

STIEFEL LABS INC

* STIEFEL LABORATORIES INC

FABIOR, TAZAROTENE

SORIATANE, ACITRETIN

SORILUX, CALCIPOTRIENE

STRIDES ARCOLAB LTD

* STRIDES ARCOLAB LTD

AMPICILLIN SODIUM, AMPICILLIN SODIUM

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

STRIDES PHARMA

* STRIDES PHARMA GLOBAL PTE LTD

ACARBOSE, ACARBOSE

BENZONATATE, BENZONATATE

CALCITRIOL, CALCITRIOL

ERGOCALCIFEROL, ERGOCALCIFEROL

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

(OTC)

IMIQUIMOD, IMIQUIMOD

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

MELOXICAM, MELOXICAM

METHOXSALEN, METHOXSALEN

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NEVIRAPINE, NEVIRAPINE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 139

PRODUCT NAME SORTED BY APPLICANT

**

**

* STRIDES PHARMA GLOBAL PTE LTD

TACROLIMUS, TACROLIMUS

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

SUCAMPO PHARMA LLC

* SUCAMPO PHARMA AMERICAS LLC

AMITIZA, LUBIPROSTONE

SUMMERS

* SUMMERS LABORATORIES INC

CROTAN, CROTAMITON

SUN PHARM INDS

* SUN PHARMACEUTICAL INDUSTRIES INC

ATENOLOL, ATENOLOL

CARISOPRODOL, CARISOPRODOL

CHLORTHALIDONE, CHLORTHALIDONE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SYNALGOS-DC, ASPIRIN

* SUN PHARMACEUTICAL INDUSTRIES LTD

CARBIDOPA AND LEVODOPA, CARBIDOPA

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

DESLORATADINE, DESLORATADINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OLANZAPINE, OLANZAPINE

ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

TORSEMIDE, TORSEMIDE

SUN PHARM INDS (IN)

* SUN PHARMACEUTICAL INDUSTRIES LTD

CEPHALEXIN, CEPHALEXIN

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

SUN PHARM INDS INC

* SUN PHARMACEUTICAL INDUSTRIES INC

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATENOLOL, ATENOLOL

BACLOFEN, BACLOFEN

BENZONATATE, BENZONATATE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLONAZEPAM, CLONAZEPAM

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SUN PHARMACEUTICAL INDUSTRIES INC

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLOZAPINE, CLOZAPINE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DIGOXIN, DIGOXIN

ELIXOPHYLLIN, THEOPHYLLINE

ERGOCALCIFEROL, ERGOCALCIFEROL

FLURBIPROFEN, FLURBIPROFEN

FUROSEMIDE, FUROSEMIDE

GEMFIBROZIL, GEMFIBROZIL

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLIPIZIDE, GLIPIZIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LITHIUM CARBONATE, LITHIUM CARBONATE

MELOXICAM, MELOXICAM

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MORPHINE SULFATE, MORPHINE SULFATE

NIMODIPINE, NIMODIPINE

NITROFURANTOIN, NITROFURANTOIN

OXAPROZIN, OXAPROZIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

REPAGLINIDE, REPAGLINIDE

RISPERIDONE, RISPERIDONE

THEOCHRON, THEOPHYLLINE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SUN PHARM INDS LTD

* SUN PHARMACEUTICAL INDUSTRIES LTD

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAMINOPHEN, ACETAMINOPHEN
(OTC)

ACYCLOVIR, ACYCLOVIR

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

CARISOPRODOL, CARISOPRODOL

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

B - 140

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

B - 141

PRODUCT NAME SORTED BY APPLICANT

**

**

* SUN PHARMACEUTICAL INDUSTRIES LTD

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLARITHROMYCIN, CLARITHROMYCIN

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

FAMOTIDINE, FAMOTIDINE
(OTC)

FELODIPINE, FELODIPINE

FENOFIBRATE, FENOFIBRATE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

GLYCOPYRROLATE, GLYCOPYRROLATE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

KENALOG, TRIAMCINOLONE ACETONIDE

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE

(OTC)

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE

(OTC)

LORATADINE REDIDOSE, LORATADINE

(OTC)

LORATADINE, LORATADINE
(OTC)

LORAZEPAM, LORAZEPAM

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

(OTC)

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

OPCICON ONE-STEP, LEVONORGESTREL

(OTC)

OXCARBAZEPINE, OXCARBAZEPINE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

(OTC)

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RILUZOLE, RILUZOLE

RIOMET, METFORMIN HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SOTRET, ISOTRETINOIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TOPIRAMATE, TOPIRAMATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SUN PHARMACEUTICAL INDUSTRIES LTD

VALPROIC ACID, VALPROIC ACID

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* SUN PHARMACEUTICAL INDUSTRIES LTD.

ANASTROZOLE, ANASTROZOLE

SUN PHARMA GLOBAL

* SUN PHARMA GLOBAL FZE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DECITABINE, DECITABINE

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DESVENLAFAXINE, DESVENLAFAXINE FUMARATE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOCEFREZ, DOCETAXEL

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTACAPONE, ENTACAPONE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ESZOPICLONE, ESZOPICLONE

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FINASTERIDE, FINASTERIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

IMATINIB MESYLATE, IMATINIB MESYLATE

LANSOPRAZOLE, LANSOPRAZOLE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NIACIN, NIACIN

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TEMOZOLOMIDE, TEMOZOLOMIDE

TETRABENAZINE, TETRABENAZINE

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ZOLMITRIPTAN, ZOLMITRIPTAN

* SUN PHARMA GLOBAL INC

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

AMIFOSTINE, AMIFOSTINE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

CARBOPLATIN, CARBOPLATIN

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

B - 142

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

SUNEVA MEDCL

* SUNEVA MEDICAL INC

TRETINOIN, TRETINOIN

SUNOVION

* SUNOVION PHARMACEUTICALS INC

BROVANA, ARFORMOTEROL TARTRATE

XOPENEX HFA, LEVALBUTEROL TARTRATE

SUNOVION PHARMS INC

* SUNOVION PHARMACEUTICALS INC

APTIOM, ESLICARBAZEPINE ACETATE

LATUDA, LURASIDONE HYDROCHLORIDE

LUNESTA, ESZOPICLONE

SUNSHINE LAKE

* SUNSHINE LAKE PHARMA CO LTD

ZIDOVUDINE, ZIDOVUDINE

SUNSTAR AMERICAS

* SUNSTAR AMERICAS INC

PAROEX, CHLORHEXIDINE GLUCONATE

SUPERNUS PHARMS

* SUPERNUS PHARMACEUTICALS INC

OXTELLAR XR, OXCARBAZEPINE

TROKENDI XR, TOPIRAMATE

SUVEN LIFE

* SUVEN LIFE SCIENCES LTD

MALATHION, MALATHION

SVADS HOLDINGS SA

* SVADS HOLDINGS SA

IBUPROFEN, IBUPROFEN
(OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

SVC PHARMA

* SVC PHARMA LP

DRONABINOL, DRONABINOL

SWAN PHARMS LLC

* SWAN PHARMACEUTICALS LLC

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

SWEDISH ORPHAN

* SWEDISH ORPHAN BIOVITRUM AB PUBL

ORFADIN, NITISINONE

SYMPLMED PHARMS LLC

* SYMPLMED PHARMACEUTICALS LLC

ACEON, PERINDOPRIL ERBUMINE

PRESTALIA, AMLODIPINE BESYLATE

SYNTHON PHARMS

* SYNTHON PHARMACEUTICALS INC

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

**

**

METHODIST HOSP RES

* THE METHODIST HOSP RESEARCH INSTITUTE

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

RITEDOSE CORP

* THE RITEDOSE CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

TAIHO ONCOLOGY

* TAIHO ONCOLOGY INC

LONSURF, TIPIRACIL HYDROCHLORIDE

TAKEDA GMBH

* TAKEDA GMBH

ALVESCO, CICLESONIDE

OMNARIS, CICLESONIDE

B - 143

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TAKEDA GMBH

ZETONNA, CICLESONIDE

TAKEDA PHARMS USA

* TAKEDA PHARMACEUTICALS USA INC

ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE

ACTOPLUS MET, METFORMIN HYDROCHLORIDE

ACTOS, PIOGLITAZONE HYDROCHLORIDE

BRINTELLIX, VORTIOXETINE HYDROBROMIDE

COLCRYS, COLCHICINE

CONTRAVE, BUPROPION HYDROCHLORIDE

DEXILANT, DEXLANSOPRAZOLE

DUETACT, GLIMEPIRIDE

KAZANO, ALOGLIPTIN BENZOATE

NESINA, ALOGLIPTIN BENZOATE

OSENI, ALOGLIPTIN BENZOATE

PREVACID, LANSOPRAZOLE

PREVPAC, AMOXICILLIN

ROZEREM, RAMELTEON

ULORIC, FEBUXOSTAT

TALON THERAP

* TALON THERAPEUTICS INC

MARQIBO KIT, VINCRISTINE SULFATE

TAMARANG

* TAMARANG SA

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

TARO

* TARO PHARMACEUTICAL INDUSTRIES LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

CARBAMAZEPINE, CARBAMAZEPINE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

DESONIDE, DESONIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FLUCONAZOLE, FLUCONAZOLE

FLUOROURACIL, FLUOROURACIL

GABAPENTIN, GABAPENTIN

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

IMIQUIMOD, IMIQUIMOD

KETOCONAZOLE, KETOCONAZOLE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LORATADINE, LORATADINE
(OTC)

MELOXICAM, MELOXICAM

METRONIDAZOLE, METRONIDAZOLE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

PHENYTOIN, PHENYTOIN

* TARO PHARMACEUTICALS INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

CLOTRIMAZOLE, CLOTRIMAZOLE
(OTC)

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

MICONAZOLE NITRATE, MICONAZOLE NITRATE

(OTC)

B - 144

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TARO PHARMACEUTICALS INC

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

TOPICORT, DESOXIMETASONE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

WARFARIN SODIUM, WARFARIN SODIUM

* TARO PHARMACEUTICALS USA INC

ACETIC ACID, ACETIC ACID, GLACIAL

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMMONIUM LACTATE, AMMONIUM LACTATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CICLOPIROX, CICLOPIROX

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

DERMABET, BETAMETHASONE VALERATE

DESONIDE, DESONIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUOROURACIL, FLUOROURACIL

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE, HYDROCORTISONE

KETOZOLE, KETOCONAZOLE

KEVEYIS, DICHLORPHENAMIDE

LIDOCAINE, LIDOCAINE

LORATADINE, LORATADINE
(OTC)

MICONAZOLE 3, MICONAZOLE NITRATE

(OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

PHENYTOIN, PHENYTOIN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

(OTC)

TERCONAZOLE, TERCONAZOLE

TERIL, CARBAMAZEPINE

TOPICORT, DESOXIMETASONE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIVAGIZOLE 3, CLOTRIMAZOLE
(OTC)

U-CORT, HYDROCORTISONE ACETATE

* TARO PHARMACEUTICALS, INC.

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

TOPICORT, DESOXIMETASONE

TARO PHARM INDS

* TARO PHARMACEUTICAL INDUSTRIES LTD

AMCINONIDE, AMCINONIDE

CARBAMAZEPINE, CARBAMAZEPINE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DESLORATADINE, DESLORATADINE

B - 145

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TARO PHARMACEUTICAL INDUSTRIES LTD

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

LAMOTRIGINE, LAMOTRIGINE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

TARO PHARMS IRELAND

* TARO PHARMACEUTICALS IRELAND LTD

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

TARO PHARMS NORTH

* TARO PHARMACEUTICALS NORTH AMERICA INC

ACETAMINOPHEN, ACETAMINOPHEN
(OTC)

INFANTS' FEVERALL, ACETAMINOPHEN

(OTC)

OVIDE, MALATHION

TOPICORT, DESOXIMETASONE

TEDOR PHARM

* TEDOR PHARMA INC

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

TEDOR PHARMA INC

* TEDOR PHARMA INC

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

TEIKOKU PHARMA

* TEIKOKU PHARMA USA INC

DOCETAXEL, DOCETAXEL

TEIKOKU PHARMA USA

* TEIKOKU PHARMA USA INC

LIDODERM, LIDOCAINE

TESARO INC

* TESARO INC

VARUBI, ROLAPITANT HYDROCHLORIDE

TEVA

* TEVA NEUROSCIENCE INC

AZILECT, RASAGILINE MESYLATE

* TEVA PHARMACEUTICALS USA INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACYCLOVIR, ACYCLOVIR

ADIPEX-P, PHENTERMINE HYDROCHLORIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN PEDIATRIC, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF, AMPHETAMINE

ATENOLOL, ATENOLOL

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CALCITRIOL, CALCITRIOL

CAPTOPRIL, CAPTOPRIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARVEDILOL, CARVEDILOL

CEFACLOR, CEFACLOR

CEFPROZIL, CEFPROZIL

CELECOXIB, CELECOXIB

CEPHALEXIN, CEPHALEXIN

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CILOSTAZOL, CILOSTAZOL

CIMETIDINE, CIMETIDINE

CLARITHROMYCIN, CLARITHROMYCIN

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

B - 146

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TEVA PHARMACEUTICALS USA INC

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOTRIMAZOLE, CLOTRIMAZOLE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DIFLUNISAL, DIFLUNISAL

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

EPITOL, CARBAMAZEPINE

ESTAZOLAM, ESTAZOLAM

ESZOPICLONE, ESZOPICLONE

ETODOLAC, ETODOLAC

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE
(OTC)

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE

(OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE

(OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GALZIN, ZINC ACETATE

GEMFIBROZIL, GEMFIBROZIL

GLIMEPIRIDE, GLIMEPIRIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

GLYBURIDE, GLYBURIDE

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

KETOCONAZOLE, KETOCONAZOLE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LAMOTRIGINE, LAMOTRIGINE

LEVOFLOXACIN, LEVOFLOXACIN

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE
(OTC)

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOVASTATIN, LOVASTATIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MUPIROCIN, MUPIROCIN

NABUMETONE, NABUMETONE

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN, NAPROXEN

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

B - 147

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TEVA PHARMACEUTICALS USA INC

NYSTATIN, NYSTATIN

OFLOXACIN, OFLOXACIN

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

ORAP, PIMOZIDE

OXAPROZIN, OXAPROZIN

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENICILLIN-VK, PENICILLIN V POTASSIUM

PIROXICAM, PIROXICAM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRELONE, PREDNISOLONE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIBAVIRIN, RIBAVIRIN

RISPERIDONE, RISPERIDONE

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ROSIGLITAZONE MALEATE, ROSIGLITAZONE MALEATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SUCRALFATE, SUCRALFATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

TOPIRAMATE, TOPIRAMATE

TORSEMIDE, TORSEMIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRIMETHOPRIM, TRIMETHOPRIM

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

TEVA BRANDED PHARM

* TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A

DIAMOX, ACETAZOLAMIDE

LOSEASONIQUE, ETHINYL ESTRADIOL

PLAN B ONE-STEP, LEVONORGESTREL

(OTC)

PLAN B, LEVONORGESTREL

PLAN B, LEVONORGESTREL
(OTC)

PROAIR HFA, ALBUTEROL SULFATE

PROAIR RESPICLICK, ALBUTEROL SULFATE

PROGLYCEM, DIAZOXIDE

QNASL, BECLOMETHASONE DIPROPIONATE

QUARTETTE, ETHINYL ESTRADIOL

QVAR 40, BECLOMETHASONE DIPROPIONATE

QVAR 80, BECLOMETHASONE DIPROPIONATE

SEASONALE, ETHINYL ESTRADIOL

SEASONIQUE, ETHINYL ESTRADIOL

ZECUITY, SUMATRIPTAN SUCCINATE

TEVA PARENTERAL

* TEVA PARENTERAL MEDICINES INC

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

TEVA PHARMS

* TEVA PHARMACEUTICALS USA

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

B - 148

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TEVA PHARMACEUTICALS USA

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

AZITHROMYCIN, AZITHROMYCIN

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BUDESONIDE, BUDESONIDE

CARBAMAZEPINE, CARBAMAZEPINE

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPROZIL, CEFPROZIL

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CROMOLYN SODIUM, CROMOLYN SODIUM

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DESONIDE, DESONIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

FAMCICLOVIR, FAMCICLOVIR

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

GABAPENTIN, GABAPENTIN

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HYDROCORTISONE, HYDROCORTISONE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

IRBESARTAN, IRBESARTAN

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LANSOPRAZOLE, LANSOPRAZOLE

LEFLUNOMIDE, LEFLUNOMIDE

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LINEZOLID, LINEZOLID

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

MELOXICAM, MELOXICAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROGESTERONE, PROGESTERONE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUININE SULFATE, QUININE SULFATE

RAMIPRIL, RAMIPRIL

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

B - 149

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APPENDIX B

B - 150

PRODUCT NAME SORTED BY APPLICANT

**

**

* TEVA PHARMACEUTICALS USA

TRANDOLAPRIL, TRANDOLAPRIL

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

URSODIOL, URSODIOL

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VANDAZOLE, METRONIDAZOLE

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ZALEPLON, ZALEPLON

TEVA PHARMS USA

* TEVA PHARMACEUTICALS USA

ACITRETIN, ACITRETIN

ADENOSINE, ADENOSINE

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

ALPROSTADIL, ALPROSTADIL

AMIKACIN SULFATE, AMIKACIN SULFATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

ARGATROBAN IN 0.9% SODIUM CHLORIDE, ARGATROBAN

ARIPIPRAZOLE, ARIPIPRAZOLE

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CLARAVIS, ISOTRETINOIN

CLOZAPINE, CLOZAPINE

COPAXONE, GLATIRAMER ACETATE

CYTOSAR-U, CYTARABINE

DACARBAZINE, DACARBAZINE

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

ENTECAVIR, ENTECAVIR

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM

EPTIFIBATIDE, EPTIFIBATIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ETOPOSIDE, ETOPOSIDE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUOROURACIL, FLUOROURACIL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

IFOSFAMIDE/MESNA KIT, IFOSFAMIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LINEZOLID, LINEZOLID

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MESNA, MESNA

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TEVA PHARMACEUTICALS USA

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MYCOPHENOLIC ACID, MYCOPHENOLIC ACID

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PARICALCITOL, PARICALCITOL

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PROPOFOL, PROPOFOL

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RAMELTEON, RAMELTEON

RISEDRONATE SODIUM, RISEDRONATE SODIUM

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOBRAMYCIN, TOBRAMYCIN

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ZANOSAR, STREPTOZOCIN

ZOLMITRIPTAN, ZOLMITRIPTAN

* TEVA PHARMACEUTICALS USA INC

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

CAPECITABINE, CAPECITABINE

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

METRONIDAZOLE, METRONIDAZOLE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

SELFEMRA, FLUOXETINE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TEVA PHARMS USA INC

* TEVA PHARMACEUTICALS USA INC

ADASUVE, LOXAPINE

TEVA WOMENS

* TEVA WOMENS HEALTH INC

ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B

PARAGARD T 380A, COPPER

REVIA, NALTREXONE HYDROCHLORIDE

ZEBETA, BISOPROLOL FUMARATE

ZIAC, BISOPROLOL FUMARATE

THE FEINSTEIN INST

* THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

THE MEDICINES CO

* THE MEDICINES CO

ANGIOMAX, BIVALIRUDIN

CLEVIPREX, CLEVIDIPINE

IONSYS, FENTANYL HYDROCHLORIDE

KENGREAL, CANGRELOR

ORBACTIV, ORITAVANCIN DIPHOSPHATE

THE PHARMA NETWORK

* THE PHARMA NETWORK LLC

BENZONATATE, BENZONATATE

THE PHARMANETWORK

* THE PHARMANETWORK LLC

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

THEPHARMANETWORK LLC

B - 151

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* THEPHARMANETWORK LLC

BENZONATATE, BENZONATATE

ISONIAZID, ISONIAZID

NIMODIPINE, NIMODIPINE

THERMAZENE, SILVER SULFADIAZINE

THERAKOS

* THERAKOS INC

UVADEX, METHOXSALEN

THERATECHNOLOGIES

* THERATECHNOLOGIES INC

EGRIFTA, TESAMORELIN ACETATE

THERAVANCE BIOPHARMA

* THERAVANCE BIOPHARMA ANTIBIOTICS INC

VIBATIV, TELAVANCIN HYDROCHLORIDE

THREE RIVERS PHARMS

* THREE RIVERS PHARMACEUTICALS LLC

RIBASPHERE, RIBAVIRIN

RIBAVIRIN, RIBAVIRIN

TOLMAR

* TOLMAR INC

ADAPALENE, ADAPALENE

ATRIDOX, DOXYCYCLINE HYCLATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE, CALCIPOTRIENE

CICLOPIROX, CICLOPIROX

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DICLOFENAC SODIUM , DICLOFENAC SODIUM

ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

IMIQUIMOD, IMIQUIMOD

KETOCONAZOLE, KETOCONAZOLE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE AND PRILOCAINE, LIDOCAINE

METRONIDAZOLE, METRONIDAZOLE

MOMETASONE FUROATE, MOMETASONE FUROATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

TOLMAR THERAP

* TOLMAR THERAPEUTICS INC

ELIGARD, LEUPROLIDE ACETATE

TORPHARM

* TORPHARM INC

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

(OTC)

TORRENT PHARM

* TORRENT PHARMA INC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

TORRENT PHARMA INC

* TORRENT PHARMA INC

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

TORRENT PHARMS

* TORRENT PHARMACEUTICALS LIMITED

LEVOFLOXACIN, LEVOFLOXACIN

* TORRENT PHARMACEUTICALS LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CARBAMAZEPINE, CARBAMAZEPINE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

B - 152

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APPENDIX B

B - 153

PRODUCT NAME SORTED BY APPLICANT

**

**

* TORRENT PHARMACEUTICALS LTD

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* TORRENT PHARMACEUTICALS LTD.

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

TORRENT PHARMS LLC

* TORRENT PHARMACEUTICALS LLC

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

OLANZAPINE, OLANZAPINE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

TORRENT PHARMS LTD

* TORRENT PHARMACEUTICALS LTD

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CELECOXIB, CELECOXIB

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FELODIPINE, FELODIPINE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

VALSARTAN, VALSARTAN

TRIAD ISOTOPES INC

* TRIAD ISOTOPES INC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

TRIBUTE PHARMS INTL

* TRIBUTE PHARMACEUTICALS INTERNATIONAL INC

FIBRICOR, FENOFIBRIC ACID

TRIS PHARMA INC

* TRIS PHARMA INC

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE

(OTC)

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX

(OTC)

DYANAVEL XR, AMPHETAMINE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX

IBUPROFEN, IBUPROFEN
(OTC)

KARBINAL ER, CARBINOXAMINE MALEATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TRIS PHARMA INC

LEVETIRACETAM, LEVETIRACETAM

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

THEOPHYLLINE, THEOPHYLLINE

TRUSTEES UNIV PA

* TRUSTEES OF THE UNIV OF PENNSYLVANIA

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

TRYGG

* TRYGG PHARMA INC

OMTRYG, OMEGA-3-ACID ETHYL ESTERS

TURING PHARMS AG

* TURING PHARMACEUTICALS AG

DARAPRIM, PYRIMETHAMINE

TWI PHARMS INC

* TWI PHARMACEUTICALS INC

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

NIFEDIPINE, NIFEDIPINE

**

**

UCB INC

* UCB INC

KEPPRA XR, LEVETIRACETAM

KEPPRA, LEVETIRACETAM

METADATE CD, METHYLPHENIDATE HYDROCHLORIDE

METADATE ER, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

NEUPRO, ROTIGOTINE

TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX

UNIRETIC, HYDROCHLOROTHIAZIDE

UNIVASC, MOEXIPRIL HYDROCHLORIDE

VIMPAT, LACOSAMIDE

XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

ZAROXOLYN, METOLAZONE

UCLA BIOMEDICAL

* UCLA BIOMEDICAL CYCLOTRON

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

UCSF RODIOPHARM

* UCSF RADIOPHARMACEUTICAL FACILITY

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

UIHC PET IMAGING

* UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

UNICHEM

* UNICHEM LABORATORIES LTD

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MELOXICAM, MELOXICAM

ZALEPLON, ZALEPLON

UNICHEM LABS LTD

* UNICHEM LABORATORIES LIMITED

B - 154

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* UNICHEM LABORATORIES LIMITED

DIVALPROEX SODIUM, DIVALPROEX SODIUM

* UNICHEM LABORATORIES LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

IRBESARTAN, IRBESARTAN

LAMOTRIGINE, LAMOTRIGINE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

UNICHEM PHARMS (USA)

* UNICHEM PHARMACEUTICALS (USA) INC

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

UNIMARK REMEDIES LTD

* UNIMARK REMEDIES LTD

MONTELUKAST SODIUM, MONTELUKAST SODIUM

UNIQUE PHARM LABS

* UNIQUE PHARMACEUTICAL LABORATORIES

ATENOLOL, ATENOLOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE

(OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FLUCONAZOLE, FLUCONAZOLE

LITHIUM CARBONATE, LITHIUM CARBONATE

TINIDAZOLE, TINIDAZOLE

UNITED BIOMEDCL

* UNITED BIOMEDICAL INC

TERBUTALINE SULFATE, TERBUTALINE SULFATE

UNITED GUARDIAN

* UNITED GUARDIAN INC

RENACIDIN, CITRIC ACID

UNITED THERAP

* UNITED THERAPEUTICS CORP

ORENITRAM, TREPROSTINIL DIOLAMINE

REMODULIN, TREPROSTINIL

TYVASO, TREPROSTINIL

UNIV MICHIGAN

* UNIV MICHIGAN PET RADIOPHARMACEUTICAL PRODUCTION PROGRAM

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

UNIV NORTH DAKOTA

* UNIV NORTH DAKOTA

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

UNIV TX MD ANDERSON

* UNIV TEXAS MD ANDERSON CANCER CENTER

AMMONIA N 13, AMMONIA N-13

CHOLINE C-11, CHOLINE C-11

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

UNIV UTAH CYCLOTRON

* UNIV UTAH CYCLOTRON RADIOCHEMISTRY LAB

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

UPSHER SMITH

* UPSHER SMITH LABORATORIES INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FORTICAL, CALCITONIN SALMON RECOMBINANT

KLOR-CON, POTASSIUM CHLORIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

B - 155

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* UPSHER SMITH LABORATORIES INC

MORPHINE SULFATE, MORPHINE SULFATE

NIACOR, NIACIN

NYSTATIN, NYSTATIN

ORVATEN, MIDODRINE HYDROCHLORIDE

OXANDROLONE, OXANDROLONE

PACERONE, AMIODARONE HYDROCHLORIDE

PENTOXIL, PENTOXIFYLLINE

PREVALITE, CHOLESTYRAMINE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUDEXY XR, TOPIRAMATE

SORINE, SOTALOL HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

VOGELXO, TESTOSTERONE

ZALEPLON, ZALEPLON

UPSHER SMITH LABS

* UPSHER SMITH LABORATORIES INC

KLOR-CON M10, POTASSIUM CHLORIDE

KLOR-CON M15, POTASSIUM CHLORIDE

KLOR-CON M20, POTASSIUM CHLORIDE

UPSHER-SMITH LABS

* UPSHER-SMITH LABORATORIES INC

KLOR-CON, POTASSIUM CHLORIDE

US PHARMS HOLDINGS I

* US PHARMACEUTICALS HOLDINGS I LLC

LOPRESSOR HCT, HYDROCHLOROTHIAZIDE

LOPRESSOR, METOPROLOL TARTRATE

LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE

LOTENSIN, BENAZEPRIL HYDROCHLORIDE

PARLODEL, BROMOCRIPTINE MESYLATE

US WORLD MEDS LLC

* US WORLD MEDS LLC

CORGARD, NADOLOL

US WORLDMEDS

* US WORLDMEDS LLC

APOKYN, APOMORPHINE HYDROCHLORIDE

REVONTO, DANTROLENE SODIUM

USL PHARMA

* USL PHARMA INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

ESTRADIOL, ESTRADIOL

FLUOXYMESTERONE, FLUOXYMESTERONE

JANTOVEN, WARFARIN SODIUM

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

USV NORTH AMERICA

* USV NORTH AMERICA INC

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

**
VALEANT

* VALEANT PHARMACEUTICALS INTERNATIONAL

ANCOBON, FLUCYTOSINE

BONTRIL PDM, PHENDIMETRAZINE TARTRATE

D.H.E. 45, DIHYDROERGOTAMINE MESYLATE

MIGRANAL, DIHYDROERGOTAMINE MESYLATE

MYSOLINE, PRIMIDONE

VALEANT BERMUDA

* VALEANT INTERNATIONAL BERMUDA

BENZACLIN, BENZOYL PEROXIDE

DERMATOP E EMOLLIENT, PREDNICARBATE

**

B - 156

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* VALEANT INTERNATIONAL BERMUDA

ELIDEL, PIMECROLIMUS

PENLAC, CICLOPIROX

RETIN-A, TRETINOIN

XERESE, ACYCLOVIR

ZOVIRAX, ACYCLOVIR

VALEANT INTL

* VALEANT INTERNATIONAL BARBADOS SRL

ATIVAN, LORAZEPAM

CARDIZEM CD, DILTIAZEM HYDROCHLORIDE

CARDIZEM LA, DILTIAZEM HYDROCHLORIDE

CARDIZEM, DILTIAZEM HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

NIFEDIPINE, NIFEDIPINE

RETIN-A MICRO, TRETINOIN

RETIN-A, TRETINOIN

RETIN-A-MICRO, TRETINOIN

ULTRAM ER, TRAMADOL HYDROCHLORIDE

VASERETIC, ENALAPRIL MALEATE

WELLBUTRIN XL, BUPROPION HYDROCHLORIDE

* VALEANT INTERNATIONAL SRL

BENZAMYCIN, BENZOYL PEROXIDE

VALEANT LUXEMBOURG

* VALEANT PHARMACEUTICALS LUXEMBOURG SARL

BENZAMYCIN PAK, BENZOYL PEROXIDE

ERTACZO, SERTACONAZOLE NITRATE

TARGRETIN, BEXAROTENE

VISUDYNE, VERTEPORFIN

VALEANT PHARM INTL

* VALEANT PHARMACEUTICALS INTERNATIONAL

8-MOP, METHOXSALEN

ANDROID 10, METHYLTESTOSTERONE

ANDROID 25, METHYLTESTOSTERONE

EFUDEX, FLUOROURACIL

LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE

MESTINON, PYRIDOSTIGMINE BROMIDE

OXSORALEN, METHOXSALEN

TESTRED, METHYLTESTOSTERONE

VIRAZOLE, RIBAVIRIN

ZELAPAR, SELEGILINE HYDROCHLORIDE

VALEANT PHARMS

* VALEANT PHARMACEUTICALS NORTH AMERICA

MEPHYTON, PHYTONADIONE

* VALEANT PHARMACEUTICALS NORTH AMERICA LLC

MESTINON, PYRIDOSTIGMINE BROMIDE

MINITRAN, NITROGLYCERIN

PENTOXIFYLLINE, PENTOXIFYLLINE

VALEANT PHARMS INC

* VALEANT PHARMACEUTICALS INTERNATIONAL INC

GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE

VALEANT PHARMS INTL

* VALEANT PHARMACEUTICALS INTERNATIONAL

APRISO, MESALAMINE

COLAZAL, BALSALAZIDE DISODIUM

GIAZO, BALSALAZIDE DISODIUM

UCERIS, BUDESONIDE

VALEANT PHARMS LLC

* VALEANT PHARMACEUTICALS NORTH AMERICA LLC

CAPITAL AND CODEINE, ACETAMINOPHEN

MACUGEN, PEGAPTANIB SODIUM

MESTINON, PYRIDOSTIGMINE BROMIDE

TASMAR, TOLCAPONE

TIMOPTIC-XE, TIMOLOL MALEATE

VALEANT PHARMS NORTH

* VALEANT PHARMACEUTICALS NORTH AMERICA LLC

B - 157

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* VALEANT PHARMACEUTICALS NORTH AMERICA LLC

APLENZIN, BUPROPION HYDROBROMIDE

CARAC, FLUOROURACIL

DERMATOP, PREDNICARBATE

DIASTAT ACUDIAL, DIAZEPAM

DIASTAT, DIAZEPAM

FENOFIBRATE, FENOFIBRATE

IPRIVASK, DESIRUDIN RECOMBINANT

ISORDIL, ISOSORBIDE DINITRATE

KLARON, SULFACETAMIDE SODIUM

NIFEDIPINE, NIFEDIPINE

NORITATE, METRONIDAZOLE

PEPCID, FAMOTIDINE

RENOVA, TRETINOIN

RETIN-A, TRETINOIN

TIAZAC, DILTIAZEM HYDROCHLORIDE

VASOTEC, ENALAPRIL MALEATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

XENAZINE, TETRABENAZINE

VALIDUS PHARMS

* VALIDUS PHARMACEUTICALS LLC

ROCALTROL, CALCITRIOL

VALIDUS PHARMS INC

* VALIDUS PHARMACEUTICALS INC

BUMEX, BUMETANIDE

EQUETRO, CARBAMAZEPINE

MARPLAN, ISOCARBOXAZID

VANDA PHARMS INC

* VANDA PHARMACEUTICALS INC

FANAPT, ILOPERIDONE

HETLIOZ, TASIMELTEON

VANSEN PHARMA

* VANSEN PHARMA

SPECTRACEF, CEFDITOREN PIVOXIL

VELDANA MEDICAL SA

* VELDANA MEDICAL SA

ECOZA, ECONAZOLE NITRATE

VELOXIS PHARMS INC

* VELOXIS PHARMACEUTICALS INC

ENVARSUS XR, TACROLIMUS

VERNALIS R AND D LTD

* VERNALIS R AND D LTD

TUZISTRA XR, CHLORPHENIRAMINE POLISTIREX

VEROSCIENCE

* VEROSCIENCE LLC

CYCLOSET, BROMOCRIPTINE MESYLATE

VERSAPHARM

* VERSAPHARM INC

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DESOXIMETASONE, DESOXIMETASONE

ERYTHROMYCIN, ERYTHROMYCIN

ETHOSUXIMIDE, ETHOSUXIMIDE

RIFAMPIN, RIFAMPIN

VERSAPHARM INC

* VERSAPHARM INC

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMINOCAPROIC, AMINOCAPROIC ACID

DESOXIMETASONE, DESOXIMETASONE

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

RIFAMPIN, RIFAMPIN

B - 158

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* VERSAPHARM INC

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

* VERSAPHARM INCORPORATED

TRANEXAMIC ACID, TRANEXAMIC ACID

VERTEX PHARMS

* VERTEX PHARMACEUTICALS INC

KALYDECO, IVACAFTOR

VERTEX PHARMS INC

* VERTEX PHARMACEUTICALS INC

KALYDECO, IVACAFTOR

ORKAMBI, IVACAFTOR

VERTICAL PHARMS LLC

* VERTICAL PHARMACEUTICALS LLC

DIVIGEL, ESTRADIOL

VIB

* VALEANT INTERNATIONAL BERMUDA

ZOVIRAX, ACYCLOVIR

VICURON

* VICURON PHARMACEUTICALS INC

ERAXIS, ANIDULAFUNGIN

VIFOR FRESENIUS

* VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE

VELPHORO, SUCROFERRIC OXYHYDROXIDE

VIIV HLTHCARE

* VIIV HEALTHCARE CO

COMBIVIR, LAMIVUDINE

EPIVIR, LAMIVUDINE

EPZICOM, ABACAVIR SULFATE

LEXIVA, FOSAMPRENAVIR CALCIUM

RESCRIPTOR, DELAVIRDINE MESYLATE

RETROVIR, ZIDOVUDINE

SELZENTRY, MARAVIROC

TIVICAY, DOLUTEGRAVIR SODIUM

TRIUMEQ, ABACAVIR SULFATE

TRIZIVIR, ABACAVIR SULFATE

ZIAGEN, ABACAVIR SULFATE

VINTAGE

* VINTAGE PHARMACEUTICALS LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETIC ACID, ACETIC ACID, GLACIAL

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALPRAZOLAM, ALPRAZOLAM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FOLIC ACID, FOLIC ACID

GLIMEPIRIDE, GLIMEPIRIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE, HYDROCORTISONE

LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LISINOPRIL, LISINOPRIL

NYSTATIN, NYSTATIN

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE

RISPERIDONE, RISPERIDONE

SPIRONOLACTONE, SPIRONOLACTONE

B - 159

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* VINTAGE PHARMACEUTICALS LLC

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALPROIC ACID, VALPROIC ACID

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

VINTAGE PHARMS

* VINTAGE PHARMACEUTICALS

ALPRAZOLAM, ALPRAZOLAM

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CYCLAFEM 0.5/35, ETHINYL ESTRADIOL

DISULFIRAM, DISULFIRAM

GILDAGIA, ETHINYL ESTRADIOL

GILDESS 24 FE, ETHINYL ESTRADIOL

GLYCOPYRROLATE, GLYCOPYRROLATE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

KIMIDESS, DESOGESTREL

LEVETIRACETAM, LEVETIRACETAM

METHIMAZOLE, METHIMAZOLE

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

* VINTAGE PHARMACEUTICALS INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

CARISOPRODOL, CARISOPRODOL

CLONAZEPAM, CLONAZEPAM

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DEXAMETHASONE, DEXAMETHASONE

DIAZEPAM, DIAZEPAM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

FUROSEMIDE, FUROSEMIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

HYDROCORTISONE, HYDROCORTISONE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN
(OTC)

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LACTULOSE, LACTULOSE

LEVETIRACETAM, LEVETIRACETAM

LORAZEPAM, LORAZEPAM

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

NYSTATIN, NYSTATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PERPHENAZINE, PERPHENAZINE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PREDNISONE, PREDNISONE

PRIMIDONE, PRIMIDONE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

B - 160

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* VINTAGE PHARMACEUTICALS INC

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SULFASALAZINE, SULFASALAZINE

TEMAZEPAM, TEMAZEPAM

TORSEMIDE, TORSEMIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VINTAGE PHARMS LLC

* VINTAGE PHARMACEUTICALS LLC

CYCLAFEM 1/35, ETHINYL ESTRADIOL

CYCLAFEM 7/7/7, ETHINYL ESTRADIOL

DUTASTERIDE, DUTASTERIDE

EMOQUETTE, DESOGESTREL

FELODIPINE, FELODIPINE

GILDESS 1.5/30, ETHINYL ESTRADIOL

GILDESS 1/20, ETHINYL ESTRADIOL

GILDESS FE 1.5/30, ETHINYL ESTRADIOL

GILDESS FE 1/20, ETHINYL ESTRADIOL

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

MEFENAMIC ACID, MEFENAMIC ACID

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MORPHINE SULFATE, MORPHINE SULFATE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

MYZILRA, ETHINYL ESTRADIOL

ORSYTHIA, ETHINYL ESTRADIOL

PERCOCET, ACETAMINOPHEN

PREVIFEM, ETHINYL ESTRADIOL

TRI-PREVIFEM, ETHINYL ESTRADIOL

VIRTUS PHARM

* VIRTUS PHARMACEUTICAL INC

ACARBOSE, ACARBOSE

VISTA PHARMS

* VISTA PHARMACEUTICALS INC

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

VISTAPHARM

* VISTAPHARM INC

ALBUTEROL SULFATE, ALBUTEROL SULFATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LACTULOSE, LACTULOSE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NYSTATIN, NYSTATIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PHENYTOIN, PHENYTOIN

VIVIMED LABS

* VIVIMED LABS ALATHUR PRIVATE LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

VIVUS

* VIVUS INC

QSYMIA, PHENTERMINE HYDROCHLORIDE

STENDRA, AVANAFIL

VPNA

* VALEANT PHARMACEUTICALS NORTH AMERICA

DICLOFENAC SODIUM, DICLOFENAC SODIUM

**
WA UNIV SCH MED

* WASHINGTON UNIV SCHOOL MEDICINE

AMMONIA N 13, AMMONIA N-13

WARNER CHILCOTT

**

B - 161

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WARNER CHILCOTT CO LLC

LO MINASTRIN FE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

* WARNER CHILCOTT INC

LOESTRIN 24 FE, ETHINYL ESTRADIOL

LOESTRIN FE 1/20, ETHINYL ESTRADIOL

WARNER CHILCOTT LLC

* WARNER CHILCOTT CO LLC

ACTONEL, RISEDRONATE SODIUM

ASACOL HD, MESALAMINE

ATELVIA, RISEDRONATE SODIUM

CHOLEDYL SA, OXTRIPHYLLINE

DELZICOL, MESALAMINE

ENABLEX, DARIFENACIN HYDROBROMIDE

ESTROSTEP FE, ETHINYL ESTRADIOL

FEMCON FE, ETHINYL ESTRADIOL

FEMHRT, ETHINYL ESTRADIOL

FEMTRACE, ESTRADIOL ACETATE

LO LOESTRIN FE, ETHINYL ESTRADIOL

LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL

LOESTRIN 21 1/20, ETHINYL ESTRADIOL

LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL

MINASTRIN 24 FE, ETHINYL ESTRADIOL

SARAFEM, FLUOXETINE HYDROCHLORIDE

WARNER CHILCOTT US

* WARNER CHILCOTT US LLC

ESTRACE, ESTRADIOL

WARNER IRELAND

* WARNER CHILCOTT IRELAND LTD

FEMRING, ESTRADIOL ACETATE

WATSON LABS

* WATSON LABORATORIES

FOLIC ACID, FOLIC ACID

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

MICROGESTIN 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN 1/20, ETHINYL ESTRADIOL

MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN FE 1/20, ETHINYL ESTRADIOL

NORCO, ACETAMINOPHEN

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

* WATSON LABORATORIES INC

ACARBOSE, ACARBOSE

AFEDITAB CR, NIFEDIPINE

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALLOPURINOL, ALLOPURINOL

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXAPINE, AMOXAPINE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

BACLOFEN, BACLOFEN

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CAPTOPRIL, CAPTOPRIL

CARISOPRODOL, CARISOPRODOL

CHLORZOXAZONE, CHLORZOXAZONE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

COL-PROBENECID, COLCHICINE

CYCLOSPORINE, CYCLOSPORINE

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DIAZEPAM, DIAZEPAM

B - 162

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WATSON LABORATORIES INC

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

ESTAZOLAM, ESTAZOLAM

ESTRADIOL, ESTRADIOL

ESTROPIPATE, ESTROPIPATE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE, GLIPIZIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROXOCOBALAMIN, HYDROXOCOBALAMIN

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

ISRADIPINE, ISRADIPINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL, LEVONORGESTREL
(OTC)

LEVORA 0.15/30-28, ETHINYL ESTRADIOL

LISINOPRIL, LISINOPRIL

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOW-OGESTREL-28, ETHINYL ESTRADIOL

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

MEPROBAMATE, MEPROBAMATE

METHOCARBAMOL, METHOCARBAMOL

METHYLDOPA, METHYLDOPA

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL, MINOXIDIL

MIRTAZAPINE, MIRTAZAPINE

NABUMETONE, NABUMETONE

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NATEGLINIDE, NATEGLINIDE

NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE

NICOTINE POLACRILEX, NICOTINE POLACRILEX

(OTC)

NIZATIDINE, NIZATIDINE

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

OGESTREL 0.5/50-28, ETHINYL ESTRADIOL

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREDNISOLONE, PREDNISOLONE

PREDNISONE, PREDNISONE

PRIMIDONE, PRIMIDONE

PROBENECID, PROBENECID

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUASENSE, ETHINYL ESTRADIOL

QUINIDINE SULFATE, QUINIDINE SULFATE

RAMIPRIL, RAMIPRIL

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SIMVASTATIN, SIMVASTATIN

SULFASALAZINE, SULFASALAZINE

SULINDAC, SULINDAC

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TELMISARTAN, TELMISARTAN

B - 163

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WATSON LABORATORIES INC

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TRANDOLAPRIL, TRANDOLAPRIL

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

TRIMETHOPRIM, TRIMETHOPRIM

TRIVORA-28, ETHINYL ESTRADIOL

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZOVIA 1/35E-28, ETHINYL ESTRADIOL

ZOVIA 1/50E-28, ETHINYL ESTRADIOL

* WATSON LABS INC

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

WATSON LABS FLORIDA

* WATSON LABORATORIES INC FLORIDA

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

WATSON LABS INC

* WATSON LABORATORIES INC

ACITRETIN, ACITRETIN

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMMONIUM LACTATE, AMMONIUM LACTATE

BUDESONIDE, BUDESONIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CELECOXIB, CELECOXIB

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CYCLOSPORINE, CYCLOSPORINE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

INDOMETHACIN, INDOMETHACIN

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL, LEVONORGESTREL
(OTC)

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PROPOFOL, PROPOFOL

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TRETINOIN, TRETINOIN

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

WELLSPRING PHARM

* WELLSPRING PHARMACEUTICAL CORP

DUVOID, BETHANECHOL CHLORIDE

WELLSTAT THERAP

* WELLSTAT THERAPEUTICS CORP

VISTOGARD, URIDINE TRIACETATE

XURIDEN, URIDINE TRIACETATE

B - 164

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

WEST WARD PHARM CORP

* WEST WARD PHARMACEUTICAL CORP

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

WEST-WARD PHARM CORP

* WEST-WARD PHARMACEUTICAL CORP

CEFOTETAN, CEFOTETAN DISODIUM

WI MEDCL CYCLOTRON

* WISCONSIN MEDICAL CYCLOTRON LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

WILSHIRE PHARMS INC

* WILSHIRE PHARMACEUTICALS INC

LAMOTRIGINE, LAMOTRIGINE

WOCKHARDT

* WOCKHARDT AMERICAS INC

CAPTOPRIL, CAPTOPRIL

FAMOTIDINE, FAMOTIDINE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

* WOCKHARDT EU OPERATIONS (SWISS) AG

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETIC ACID, ACETIC ACID, GLACIAL

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

BROMFED-DM, BROMPHENIRAMINE MALEATE

CARBAMAZEPINE, CARBAMAZEPINE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CROMOLYN SODIUM, CROMOLYN SODIUM

CYCLOSPORINE, CYCLOSPORINE

DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ERYTHROMYCIN, ERYTHROMYCIN

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

FUROSEMIDE, FUROSEMIDE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LINDANE, LINDANE

LITHIUM CITRATE, LITHIUM CITRATE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

LORATADINE, LORATADINE
(OTC)

MEGESTROL ACETATE, MEGESTROL ACETATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL

(OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL

(OTC)

NYSTATIN, NYSTATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PHENYTOIN, PHENYTOIN

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE

SELENIUM SULFIDE, SELENIUM SULFIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALPROIC ACID, VALPROIC ACID

* WOCKHARDT LTD

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

B - 165

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WOCKHARDT LTD
AZITHROMYCIN, AZITHROMYCIN
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOTAXIME, CEFOTAXIME SODIUM
CEFPROZIL, CEFPROZIL
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CLARITHROMYCIN, CLARITHROMYCIN
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
FAMOTIDINE, FAMOTIDINE
(OTC)
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LISINOPRIL, LISINOPRIL
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
NIACIN, NIACIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
WOCKHARDT BIO AG
* WOCKHARDT BIO AG
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
WOCKHARDT EU OPERATN
* WOCKHARDT EU OPERATIONS SWISS AG
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
DEXAMETHASONE, DEXAMETHASONE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
WOCKHARDT LTD
* WOCKHARDT LTD
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
ENTACAPONE, ENTACAPONE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
LAMOTRIGINE, LAMOTRIGINE
LANSOPRAZOLE, LANSOPRAZOLE
(OTC)
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
WOCKHARDT USA
* WOCKHARDT USA INC

B - 166

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WOCKHARDT USA INC

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

* WOCKHARDT USA LLC

ENALAPRIL MALEATE, ENALAPRIL MALEATE

LANSOPRAZOLE, LANSOPRAZOLE

WRASER PHARMS

* WRASER PHARMACEUTICALS LLC

CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE

WRASER PHARMS LLC

* WRASER PHARMACEUTICALS LLC

TREZIX, ACETAMINOPHEN

WUSM CYCLOTRON

* WASHINGTON UNIV SCH MEDICINE CYCLOTRON FACILITY

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

WYETH PHARMS

* WYETH PHARMACEUTICALS INC SUB PFIZER INC

LO/OVRAL-28, ETHINYL ESTRADIOL

WYETH PHARMS INC

* WYETH PHARMACEUTICALS INC

BOSULIF, BOSUTINIB MONOHYDRATE

CORDARONE, AMIODARONE HYDROCHLORIDE

EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE

PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE

PREMARIN, ESTROGENS, CONJUGATED

PREMPHASE 14/14, ESTROGENS, CONJUGATED

PREMPRO, ESTROGENS, CONJUGATED

PRISTIQ, DESVENLAFAXINE SUCCINATE

PROTONIX IV, PANTOPRAZOLE SODIUM

PROTONIX, PANTOPRAZOLE SODIUM

TRECATOR, ETHIONAMIDE

ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

ZOSYN, PIPERACILLIN SODIUM

WYETH PHARMS PFIZER

* WYETH PHARMACEUTICALS INC WHOLLY OWNED SUB PFIZER INC

DUAVEE, BAZEDOXIFENE ACETATE

**

**

X GEN PHARMS

* X GEN PHARMACEUTICALS INC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

AMPHOTERICIN B, AMPHOTERICIN B

BACIIM, BACITRACIN

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

LEVETIRACETAM, LEVETIRACETAM

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

NEO-FRADIN, NEOMYCIN SULFATE

NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NYSTATIN, NYSTATIN

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

X-GEN PHARMS

* X-GEN PHARMACEUTICALS INC

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

X-GEN PHARMS INC

* X-GEN PHARMACEUTICALS INC

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

LINCOMYCIN, LINCOMYCIN HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

XELLIA PHARMS APS

B - 167

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* XELLIA PHARMACEUTICALS APS

BACITRACIN, BACITRACIN

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

XENOPORT INC

* XENOPORT INC

HORIZANT, GABAPENTIN ENACARBIL

XSPIRE

* XSPIRE LLC

NALFON, FENOPROFEN CALCIUM

XTTRIUM

* XTTRIUM LABORATORIES INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

EXIDINE, CHLORHEXIDINE GLUCONATE

(OTC)

**

**

YAOPHARMA CO LTD

* YAOPHARMA CO LTD

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

YUNG SHIN PHARM

* YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD

CEFACLOR, CEFACLOR

CEPHALEXIN, CEPHALEXIN

**

**

ZACH SYSTEM SPA

* ZACH SYSTEM SPA

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

ZACH SYSTEMS

* ZACH SYSTEMS SPA

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

ZAMBON SPA

* ZAMBON SPA ITALY

MONUROL, FOSFOMYCIN TROMETHAMINE

ZYDUS HLTHCARE

* ZYDUS HEALTHCARE USA LLC

LANSOPRAZOLE, LANSOPRAZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ZYDUS PHARMS USA

* ZYDUS PHARMACEUTICALS USA INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATENOLOL, ATENOLOL

AZATHIOPRINE, AZATHIOPRINE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BENZONATATE, BENZONATATE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL

LAMOTRIGINE, LAMOTRIGINE

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN, NAPROXEN

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

RIBAVIRIN, RIBAVIRIN

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

B - 168

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ZYDUS PHARMACEUTICALS USA INC

ZONISAMIDE, ZONISAMIDE

ZYDUS PHARMS USA INC

* ZYDUS PHARMACEUTICALS USA INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ACYCLOVIR, ACYCLOVIR

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ANASTROZOLE, ANASTROZOLE

BICALUTAMIDE, BICALUTAMIDE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARVEDILOL, CARVEDILOL

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DIPYRIDAMOLE, DIPYRIDAMOLE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ETODOLAC, ETODOLAC

ETOMIDATE, ETOMIDATE

FINASTERIDE, FINASTERIDE

GABAPENTIN, GABAPENTIN

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

INDOMETHACIN, INDOMETHACIN

IRBESARTAN, IRBESARTAN

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

OMEPRAZOLE, OMEPRAZOLE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SIROLIMUS, SIROLIMUS

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TELMISARTAN, TELMISARTAN

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

B - 169

36TH EDITION - 2016 - APPROVED DRUG PRODUCTS LIST

APPENDIX C

UNIFORM TERMS
DOSAGE FORMS
AEROSOL, FOAM
AEROSOL, METERED
CAPSULE
CAPSULE, DELAYED REL PELLETS
CAPSULE, DELAYED RELEASE
CAPSULE, EXTENDED RELEASE
CLOTH
CONCENTRATE
CREAM
CREAM, AUGMENTED
ELIXIR
EMULSION
ENEMA
FILM
FILM, EXTENDED RELEASE
FOR SOLUTION
FOR SUSPENSION
FOR SUSPENSION, DELAYED RELEASE
FOR SUSPENSION, EXTENDED RELEASE
GAS
GEL
GEL, AUGMENTED
GEL, METERED
GRANULE
GRANULE, DELAYED RELEASE
GUM, CHEWING
IMPLANT
INHALANT
INJECTABLE
INJECTABLE, LIPID COMPLEX
INJECTABLE, LIPOSOMAL
INSERT
INSERT, EXTENDED RELEASE
INTRAUTERINE DEVICE
JELLY
LIQUID
LOTION
LOTION, AUGMENTED
LOTION/SHAMPOOOIL
OIL

Note: Terms comprise currently marketed products

OIL/DROPS
OINTMENT
OINTMENT, AUGMENTED
PASTE
PATCH
PELLET
POWDER
POWDER, EXTENDED RELEASE
POWDER, METERED
RING
SHAMPOO
SOLUTION
SOLUTION FOR SLUSH
SOLUTION, GEL FORMING/DROPS
SOLUTION, METERED
SOLUTION/DROPS
SPONGE
SPRAY
SPRAY, METERED
SUPPOSITORY
SUSPENSION
SUSPENSION, EXTENDED RELEASE
SUSPENSION/DROPS
SWAB
SYRUP
SYSTEM
SYSTEM, EXTENDED RELEASE
TABLET
TABLET, CHEWABLE
TABLET, COATED PARTICLES
TABLET, DELAYED RELEASE
TABLET, DELAYED RELEASE, ORALLY
DISINTEGRATING
TABLET, EFFERVESCENT
TABLET, EXTENDED RELEASE
TABLET, FOR SUSPENSION
TABLET, ORALLY DISINTEGRATING
TAPE
TROCHE/LOZENGE

C-1

36TH EDITION - 2016 - APPROVED DRUG PRODUCTS LIST

APPENDIX C

UNIFORM TERMS

ROUTES OF ADMINISTRATION
BUCCAL
DENTAL
ENDOCERVICAL
ENTERAL
FOR RX COMPOUNDING
IMPLANTATION
INHALATION
INJECTION
INTRA-ANAL
INTRACRANIAL
INTRADERMAL
INTRAMUSCULAR
INTRAOCULAR
INTRAPERITONEAL
INTRAPLEURAL
INTRATHECAL
INTRATRACHEAL
INTRAUTERINE
INTRAVENOUS
INTRAVESICAL
INTRAVITREAL

Note: Terms comprise currently marketed products

IONTOPHORESIS
IRRIGATION
IV (INFUSION)
N/A
NASAL
OPHTHALMIC
ORAL
ORAL-21
ORAL-28
OTIC
PERFUSION, CARDIAC
PERIODONTAL
RECTAL
SPINAL
SUBCUTANEOUS
SUBLINGUAL
TOPICAL
TRANSDERMAL
TRANSMUCOSAL
URETHRAL
VAGINAL

C-2

7+(',7,212015 - APPROVED DRUG PRODUCTS LIST

APPENDIX C

UNIFORM TERMS

ABBREVIATIONS

AMP
AMPICIL
APPROX
BOT
CI
CSR
CU
DIPROP
ELECT
EQ
ER
GM
HBR
HCL
HR
IM
INH
IU
IV
KIU
MCG
MCI
MEQ
MG
ML
N/A
PPM
REL
SC
SQ CM
U
UCI
UMOLAR
USP

AMPULE
AMPICILLIN
APPROXIMATELY
BOTTLE
CURIE
CAROTID SINUS REFLEX
CLINICAL UNITS
DIPROPIONATE
ELECTROLYTE
EQUIVALENT TO
EXTENDED RELEASE
GRAM
HYDROBROMIDE
HYDROCHLORIDE
HOUR
INTRAMUSCULAR
INHALATION
INTERNATIONAL UNITS
INTRAVENOUS
KALLIKREIN INHIBITOR UNITS
MICROGRAM
MILLICURIE
MILLIEQUIVALENT
MILLIGRAM
MILLILITER
NOT APPLICABLE
PARTS PER MILLION
RELEASE
SUBCUTANEOUS
SQUARE CENTIMETER
UNITS
MICROCURIE
MICROMOLAR
UNITED STATES PHARMACOPEIA

C-3

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM

This Addendum identifies drugs that qualify under the Drug Price
Competition and Patent Term Restoration Act (1984 Amendments) for periods of
exclusivity, during which abbreviated new drug applications (ANDAs) and
applications described in Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) for those drug products may, in some instances,
not be submitted or made effective as described below, and provides patent
information concerning the listed drug products. Those drugs that have
qualified for Orphan Drug Exclusivity pursuant to Section 527 of the FD&C
Act, those drugs that have qualified for Pediatric Exclusivity pursuant to
Section 505A of the FD&C Act, and those drugs that have qualified for
Generating Antibiotics Incentives Now (GAIN) exclusivity pursuant to Section
505E of the FD&C Act are also included in this Addendum. This section is
arranged in alphabetical order by active ingredient name followed by the
trade name. Active ingredient headings for multiple ingredient (combination)
drug products are arranged alphabetically. For an explanation of the codes
used in the Addendum, see the Patent and Exclusivity Terms Section. The
exclusivity codes are general shorthand descriptions and do not necessarily
identify, with specificity, the actual scope of exclusivity. Exclusivity
prevents the submission or effective approval of ANDAs or applications
described in Section 505(b)(2) of the FD&C Act. It does not prevent the
submission or approval of a second 505(b)(1) application except in the case
of Orphan Drug exclusivity. Applications qualifying for periods of
exclusivity include:
(1)

(2)

A new drug application approved after September 24, 1984, for a drug
product (including an ester or salt of the active ingredient) of which
has never been approved in any other new drug application under Section
505 (b) of the FD&C Act. No subsequent ANDA or application described in
Section 505(b)(2) of the FD&C Act for the same drug may be submitted for
a period of five years from the date of approval of the original
application, except that such an application may be submitted after four
years if it contains a certification that a patent claiming the drug is
invalid or will not be infringed by the product for which approval is
sought.
A new drug application approved after September 24, 1984, for a drug
product containing an active ingredient (including any ester or salt of
that active ingredient) that has been approved in an earlier new drug
application and that includes reports of new clinical investigations
(other than bioavailability studies). Such investigations must have
been conducted or sponsored by the applicant and must have been
essential to approval of the application. If these requirements are
met, the approval of a subsequent ANDA or an application described in
Section 505(b)(2) of the FD&C Act may not be made effective for the same
drug or use, if for a new indication, before the expiration of three
years from the date of approval of the original application. If an
applicant has exclusivity for a new application or 505(b)(2) application
for the drug product with indications or use, this does not preclude the
approval of an ANDA or 505(b)(2) application not covered by the
exclusivity.

(3) A supplement to a new drug application for a drug containing a

previously approved active ingredient including (any ester or salt of
the active ingredient) approved after September 24, 1984, that contains
AD 1

reports of new clinical investigations (other than bioavailability

studies) essential to the approval of the supplement and conducted or
sponsored by the applicant. The approval of a subsequent ANDA or
505(b)(2) application for a change approved in the supplement may not be
made effective for three years from the date of approval of the original
supplement.
The FD&C Act requires that patent information be filed with all newly
submitted Section 505(b) drug applications. No NDA may be approved after
September 24, 1984, without the submission of patent information to the
Agency. Effective August 18, 2003, this information must be filed using FDA
Form 3524a Patent Information Submitted with the Filing of an NDA, Amendment
or Supplement.
Effective August 18, 2003, upon approval of an application, patent
information for purposes of listing in the Orange Book must be submitted to
the Agency within 30 days of approval on FDA Form 3542 Patent Information
Submitted Upon and After Approval of an NDA or Supplement. Patent
information on unapproved applications or on patents beyond the scope of the
FD&C Act (i.e., process or manufacturing patents) will not be published. FDA
Form 3542 will be the only form used for the purposes of this publication.
The patents that FDA regards as covered by the statutory provisions for
submission of patent information are: patents that claim the active
ingredient(s); drug product patents which include formulation/composition
patents; use patents for a particular approved indication or method of using
the product; and certain other patents as detailed on FDA Form 3542. This
information, as provided by the sponsor on FDA Form 3542, will be published
as described above.
A requirement for submission of patent information to FDA for certain
old antibiotics became effective October 7, 2008 under section 4(b)(1) of the
QI Program Supplemental Funding Act (Public Law 110-379) (QI Act). A
guidance for industry on this subject is available at
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/gu
idances/ucm080566.pdf.
Upon approval, patent numbers and expiration dates, in addition to
certain other information on appropriate patents claiming drug products that
are the subject of approved applications, will be published daily in the
Electronic Orange Book Query. The Addendum lists patent and exclusivity
information up to January of the Edition year. The monthly Cumulative
Supplements to the annual edition list patent and exclusivity information
changes since the Annual Edition Addendum. Since all parts of this
publication are subject to changes, additions, or deletions, the Electronic
Orange Book, updated daily, should be consulted for the most recent patent
and exclusivity information.

AD 2

ADA 1 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ABACAVIR SULFATE - ZIAGEN

N 020977 001 6294540

May 14, 2018

DS DP U-65

D-147

Mar 23, 2018

ABACAVIR SULFATE - ZIAGEN

N 020978 001 6294540
6641843

May 14, 2018

Feb 04, 2019

DS DP U-65
DP

D-147

Mar 23, 2018

NCE

Aug 12, 2018

I-663
NCE

Dec 10, 2015

Apr 28, 2016

NP

Mar 11, 2017

NCE

Jul 23, 2017

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE N 205551 001 5905082

May 18, 2016
DS
5905082*PED
Nov 18, 2016
6294540
May 14, 2018
DS
6294540*PED
Nov 14, 2018
6417191
Mar 28, 2016
6417191*PED
Sep 28, 2016
8129385
Oct 05, 2027
DS
ABACAVIR SULFATE; LAMIVUDINE - EPZICOM
N 021652 001 5905082
May 18,
6294540
May 14,
6417191
Mar 28,
6417191*PED
Sep 28,

2016
2018
2016
2016

TRIUMEQ
DP
DP U-1572
DP U-1572
DP

DS DP
DS DP U-257
DP U-257

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - TRIZIVIR

N 021205 001 5905082
May 18, 2016
DS DP U-248
6294540
May 14, 2018
DS DP U-65
6417191
Mar 28, 2016
DP U-248
ABARELIX - PLENAXIS
N 021320 001 5843901
5968895
6180608
6699833

Dec
Dec
Dec
Dec

01,
11,
11,
11,

2015
2016
2016
2016

DS DP
DP
DP U-549
DP

ABIRATERONE ACETATE - ZYTIGA

N 202379 001 5604213
5604213
8822438
8822438

Dec
Dec
Aug
Aug

13,
13,
24,
24,

2016
2016
2027
2027

DS DP U-1126
DS DP U-1314
U-1579
U-1580

ACETAMINOPHEN - OFIRMEV
N 022450 001 6028222
6992218

Aug 05, 2017

Jun 06, 2021

DP
DP

ACETAMINOPHEN; ASPIRIN; CAFFEINE - EXCEDRIN (MIGRAINE)

N 020802 001 5972916
Jul 14, 2017
U-296
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE N 204031 001 6488962
Jun 20,
7976870
Jun 01,
8372432
Mar 11,
8377453
Nov 19,
8394408
Mar 11,
8597681
Dec 21,
8658631
May 16,
8668929
Mar 11,
8741885
May 16,
8980319
Dec 21,
8992975
May 16,
9050335
May 16,

XARTEMIS XR
2020
DP
2027
U-1498
2029
DP U-1499
2029
DP U-1499
2029
DP
2030
DP
2032
DP
2029
U-1499
2032
DP U-1499
2030
DP
2032
DP
2032
DP

ACETYLCYSTEINE - ACETADOTE
N 021539 001 8148356
8399445
8653061
8722738

2026
2025
2025
2032

May
Aug
Aug
Apr

21,
24,
24,
06,

ACLIDINIUM BROMIDE - TUDORZA PRESSAIR

N 202450 001 5840279
Jun 21, 2016
6071498
Jun 21, 2016
6681768
Aug 07, 2022

DP
U-1373
U-1373
U-1373

DP
DP
DP

ADA 2 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
ACLIDINIUM BROMIDE - TUDORZA PRESSAIR

N 202450 001 6750226
Sep 05, 2020
7078412
Jul 16, 2020
8051851
Apr 22, 2027
9056100
Jul 07, 2020
PATENT NO

ACYCLOVIR - SITAVIG

N 203791 001 8592434
8747896
8791127

Jun 16, 2030

Jun 03, 2027
Mar 23, 2027

ACYCLOVIR; HYDROCORTISONE - XERESE

N 022436 001 6514980
Jan
6514980
Jan
7223387
Jul
7223387
Jul
RE39264
Aug
RE39264
Aug

24,
24,
24,
24,
02,
02,

2019
2019
2021
2021
2016
2016

ADAPALENE - DIFFERIN

N 021753 001 7579377
7737181
7834060
7838558
7868044
8703820

Feb
Aug
Mar
Mar
Mar
Mar

23,
29,
12,
12,
12,
12,

2025
2024
2023
2023
2023
2023

ADAPALENE - DIFFERIN

N 022502 001 7998467
8435502
8709392

May 31, 2028

Sep 15, 2026
Sep 15, 2026

ADAPALENE; BENZOYL PEROXIDE - EPIDUO

N 022320 001 7820186
Nov 23,
7964202
Sep 01,
8071644
Jul 18,
8080537
Jul 18,
8105618
Dec 23,
8129362
Jul 18,
8241649
Dec 23,
8445543
Jul 12,
8809305
Dec 23,
8936800
Dec 23,

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DS DP U-1264

DS DP U-1263

DP

DP U-1263

DP U-1460
DP U-1460

DP U-1460

NP

Apr 12, 2016

DP
DP
DP
DP
DP
DP

NPP

Jan 22, 2017

U-1006
U-1484

U-1006

U-1484

U-1006

U-1484

U-818

DP

U-1078

DP

U-1078

U-1078

DP U-1078

DP U-1078

DP U-1078

2025
2024
2027
2027
2022
2027
2022
2027
2022
2022

DP
DP U-1078

DP U-1078

U-1078

U-1078

U-1078

DP

U-1078

U-1078

DP U-1078

NPP

Feb 01, 2016

ADAPALENE; BENZOYL PEROXIDE - EPIDUO FORTE

N 207917 001 8445543
Jul 12, 2027
8703820
Mar 12, 2023
8729127
Mar 12, 2023
8785420
Dec 23, 2022
8909305
Dec 23, 2022
8936800
Dec 23, 2022

U-1078
U-1078

U-1078

U-1078

U-1078

DP U-1078

NP

Jul 15, 2018

ADEFOVIR DIPIVOXIL - HEPSERA

N 021449 001 6451340

Jul 23, 2018

DS DP U-470

AFATINIB DIMALEATE - GILOTRIF

N 201292 001 6251912
8426586
8545884
RE43431

Jul
Oct
Dec
Jan

29,
10,
19,
22,

2018
2029
2029
2022

DS DP U-1067
DS DP
DP

DS DP

NCE
ODE

Jul 12, 2018

Jul 12, 2020

AFATINIB DIMALEATE - GILOTRIF

N 201292 002 6251912
8426586
8545884
RE43431

Jul
Oct
Dec
Jan

29,
10,
19,
22,

2018
2029
2029
2022

DS DP U-1067
DS DP
DP

DS DP

NCE
ODE

Jul 12, 2018

Jul 12, 2020

AFATINIB DIMALEATE - GILOTRIF

N 201292 003 6251912
8426586

Jul 29, 2018

Oct 10, 2029

DS DP U-1067
DS DP

NCE
ODE

Jul 12, 2018

Jul 12, 2020

ADA 3 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

AFATINIB DIMALEATE - GILOTRIF

N 201292 003 8545884
RE43431

PATENT
EXPIRATION
DATE
Dec 19, 2029
Jan 22, 2022

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP
DS DP

ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE

N 020760 001 6080756
Jul 05, 2016
6194429
Jul 23, 2018
ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE
N 020760 002 6080756
Jul 05, 2016
6194429
Jul 23, 2018
ALBUMIN HUMAN - OPTISON
N 020899 001 6723303

Apr 20, 2021

DP

ALBUTEROL SULFATE - PROVENTIL-HFA

N 020503 001 5775321
Jul 07, 2015
6006745
Dec 28, 2016

DP
DP

ALBUTEROL SULFATE - ACCUNEB

N 020949 001 6702997

Dec 28, 2021

U-558

ALBUTEROL SULFATE - ACCUNEB

N 020949 002 6702997

Dec 28, 2021

U-558

ALBUTEROL SULFATE - VENTOLIN HFA

N 020983 001 6161724
Jan 16, 2018
6170717
Dec 23, 2017
6315173
Dec 23, 2017
6431168
Jun 08, 2018
6435372
Jan 16, 2018
6510969
Dec 23, 2017
6558651
Dec 19, 2016
6743413
Jun 01, 2021
6938796
Jan 16, 2018
6966467
Dec 23, 2017
6997349
Jan 16, 2018
7107986
Jun 08, 2018
7143908
Jan 16, 2018
7350676
Aug 24, 2018
7500444
Feb 26, 2026
7500444*PED
Aug 26, 2026
7832351
Jun 19, 2023
ALBUTEROL SULFATE - PROAIR HFA
N 021457 001 6446627
7105152
7566445
8132712
8834849

Dec
Sep
Jun
Sep
Jun

NP

Mar 12, 2018

DP

2017
2023
2017
2028
2017

DP
DP
DP
DP
DP

ALBUTEROL SULFATE - PROAIR RESPICLICK

N 205636 001 6446627
Dec 18,
6701917
Jun 23,
6718972
Jun 23,
6748947
Jun 23,
6871646
Jun 23,
7540282
May 06,
8006690
Jun 23,
8651103
Mar 26,

2017
2021
2021
2021
2021
2023
2021
2028

DP
DP
DP
DP
DP
DP
DP
DP

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE N 021747 001 5964416

Oct 04,
6149054
Dec 19,
6176442
Oct 04,
6453795
Dec 05,
6726124
Oct 04,

Aug 17, 2015

DP
DP
DP
DP
DP
DP
DP U-716
U-716
DP
DP
DP
DP
DP
DP
DP

18,
12,
04,
07,
04,

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - DUONEB

N 020950 001 6632842
Dec 28, 2021

M-120

U-532

COMBIVENT RESPIMAT
2016
DP
2016
DP
2016
DP
2016
DP
2016
DP

ADA 4 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
PATENT
DATE
CODES
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT RESPIMAT
N 021747 001 6846413
Aug 28, 2018
DP
6977042
Aug 28, 2018
DP
6988496
Feb 23, 2020
DP
7104470
Oct 04, 2016
DP
7246615
May 31, 2016
DP
7284474
Aug 26, 2024
DP
7396341
Oct 10, 2026
DP
7802568
Feb 26, 2019
DP
7837235
Mar 13, 2028
DP
7896264
May 26, 2025
DP
7988001
Aug 04, 2021
DP
8733341
Dec 16, 2029
DP
9027967
Mar 31, 2027
DP
APPL/PROD
NO

PATENT NO

ALCAFTADINE - LASTACAFT
N 022134 001 5468743
8664215

Apr 20, 2016

Dec 23, 2027

DS DP

ALENDRONATE SODIUM - FOSAMAX

N 021575 001 5994329
6015801
6225294

Jul 17, 2018

Jul 17, 2018
Jul 17, 2018

ALENDRONATE SODIUM - BINOSTO

N 202344 001 7488496
7964212

Aug 11, 2023

Mar 06, 2023

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Jul 28, 2015

NCE

Dec 11, 2020

U-1493

ALCOHOL; CHLORHEXIDINE GLUCONATE - AVAGARD

N 021074 001 5897031
Jun 21, 2016
7081246
Aug 03, 2016
ALECTINIB HYDROCHLORIDE - ALECENSA
N 208434 001 9126931
May 29, 2031

PATENT
DELIST
REQUESTED

DP

DS

Y
Y
Y

DS DP
DS DP

ALENDRONATE SODIUM; CHOLECALCIFEROL - FOSAMAX PLUS D

N 021762 001 5994329
Jul 17, 2018

U-647

ALFUZOSIN HYDROCHLORIDE - UROXATRAL

N 021287 001 6149940
Aug 22, 2017
ALISKIREN HEMIFUMARATE - TEKTURNA
N 021985 001 5559111
Jul 21, 2018
8617595
Feb 19, 2026

DS DP U-3
DP

ALISKIREN HEMIFUMARATE - TEKTURNA

N 021985 002 5559111
Jul 21, 2018
8617595
Feb 19, 2026

DS DP U-3
DP

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO

N 022545 001 5559111
Jul 21, 2018
DS DP U-3
8613949
Dec 21, 2029
DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 002 5559111
Jul 21, 2018
DS DP U-3
8613949
Dec 21, 2029
DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 003 5559111
Jul 21, 2018
DS DP U-3
8613949
Dec 21, 2029
DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 004 5559111
Jul 21, 2018
DS DP U-3
8613949
Dec 21, 2029
DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 001 5559111
Jul 21, 2018
DS DP U-3
8183295
May 16, 2023
DP
8618174
Nov 15, 2021
DP

ADA 5 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
PATENT
EXPIRATION
DELIST
PATENT
DATE
REQUESTED
CODES
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
Jul 21, 2018
DS DP U-3
May 16, 2023
DP
Nov 15, 2021
DP

PATENT NO

ALISKIREN HEMIFUMARATE;
N 200045 002 5559111
8183295
8618174

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE

N 200045 003 5559111
Jul 21, 2018
DS DP U-3
8183295
May 16, 2023
DP
8618174
Nov 15, 2021
DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 004 5559111
Jul 21, 2018
DS DP U-3
8183295
May 16, 2023
DP
8618174
Nov 15, 2021
DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 005 5559111
Jul 21, 2018
DS DP U-3
8183295
May 16, 2023
DP
8618174
Nov 15, 2021
DP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 001 5559111
Jul 21, 2018
DS DP U-3
8618172
Jul 13, 2028
DP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 002 5559111
Jul 21, 2018
DS DP U-3
8618172
Jul 13, 2028
DP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 003 5559111
Jul 21, 2018
DS DP U-3
8618172
Jul 13, 2028
DP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 004 5559111
Jul 21, 2018
DS DP U-3
8618172
Jul 13, 2028
DP
ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
N 022217 001 5559111
Jul 21, 2018
8168616
Jul 03, 2026

DS DP U-3
DP

ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA

N 022217 002 5559111
Jul 21, 2018
8168616
Jul 03, 2026

DS DP U-3
DP

ALITRETINOIN - PANRETIN
N 020886 001 5932622

Aug 03, 2016

ALOGLIPTIN BENZOATE - NESINA

N 022271 001 6150383
6211205
6303640
6303661
6329404
6890898
7078381
7459428
7807689
8173663
8288539
8697125

Jun
Jun
Aug
Apr
Jun
Feb
Feb
Feb
Jun
Mar
Mar
Jan

19,
19,
09,
24,
19,
02,
02,
02,
27,
15,
15,
22,

2016
2016
2016
2017
2016
2019
2019
2019
2028
2025
2025
2029

U-1330
U-1331
U-1332
U-1333
DP U-1334
U-1335
U-1335
U-1336
DS DP U-1337
U-1338
DS
DP

NCE

Jan 25, 2018

ALOGLIPTIN BENZOATE - NESINA

N 022271 002 6150383
6211205
6303640
6303661
6329404
6890898
7078381
7459428

Jun
Jun
Aug
Apr
Jun
Feb
Feb
Feb

19,
19,
09,
24,
19,
02,
02,
02,

2016
2016
2016
2017
2016
2019
2019
2019

U-1330
U-1331
U-1332
U-1333
DP U-1334
U-1335
U-1335
U-1336

NCE

Jan 25, 2018

U-562

ADA 6 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ALOGLIPTIN BENZOATE - NESINA

N 022271 002 7807689
8173663
8288539
8697125

Jun
Mar
Mar
Jan

27,
15,
15,
22,

2028
2025
2025
2029

DS DP U-1337

U-1338

DS

DP

ALOGLIPTIN BENZOATE - NESINA

N 022271 003 6150383
6211205
6303640
6303661
6329404
6890898
7078381
7459428
7807689
8173663
8288539
8697125

Jun
Jun
Aug
Apr
Jun
Feb
Feb
Feb
Jun
Mar
Mar
Jan

19,
19,
09,
24,
19,
02,
02,
02,
27,
15,
15,
22,

2016
2016
2016
2017
2016
2019
2019
2019
2028
2025
2025
2029

U-1330
U-1331

U-1332

U-1333

DP U-1334

U-1335

U-1335

U-1336

DS DP U-1337

U-1338

DS

DP

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO

N 203414 001 5965584
Jun 19, 2016
U-1339
6150383
Jun 19, 2016
U-1330
6150384
Jun 19, 2016
U-1340

6166042
Jun 19, 2016
U-1341

6166043
Jun 19, 2016
U-1342

6172090
Jun 19, 2016
U-1343

6211205
Jun 19, 2016
U-1331

6303640
Aug 09, 2016
U-1332

6303661
Apr 24, 2017
U-1333

6329404
Jun 19, 2016
U-1334

6890898
Feb 02, 2019
U-1335

7078381
Feb 02, 2019
U-1335

7459428
Feb 02, 2019
U-1336

7807689
Jun 27, 2028
DS DP U-1337

8173663
Mar 15, 2025
U-1338

8288539
Mar 15, 2025
DS

8900638
May 24, 2029
DP

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO

N 203414 002 5965584
Jun 19, 2016
U-1339
6150383
Jun 19, 2016
U-1330
6150384
Jun 19, 2016
U-1340

6166042
Jun 19, 2016
U-1341

6166043
Jun 19, 2016
U-1342

6172090
Jun 19, 2016
U-1343

6211205
Jun 19, 2016
U-1331

6303640
Aug 09, 2016
U-1332

6303661
Apr 24, 2017
U-1333

6329404
Jun 19, 2016
U-1334

6890898
Feb 02, 2019
U-1335

7078381
Feb 02, 2019
U-1335

7459428
Feb 02, 2019
U-1336

7807689
Jun 27, 2028
DS DP U-1337

8173663
Mar 15, 2025
U-1338

8288539
Mar 15, 2025
DS

8900638
May 24, 2029
DP

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI

N 022426 001 5965584
Jun 19, 2016
DP U-1339
6150383
Jun 19, 2016
U-1330
6150384
Jun 19, 2016
U-1340

6166042
Jun 19, 2016
U-1341

6166043
Jun 19, 2016
U-1342

6172090
Jun 19, 2016
U-1343

6211205
Jun 19, 2016
U-1331

6271243
Jun 19, 2016
U-1344

6303640
Aug 09, 2016
U-1332

6303661
Apr 24, 2017
U-1333

6329404
Jun 19, 2016
DP U-1334

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NCE

Jan 25, 2018

NC
NCE

Jan 25, 2016

Jan 25, 2018

NC
NCE

Jan 25, 2016

Jan 25, 2018

NC
NCE

Jan 25, 2016

Jan 25, 2018

ADA 7 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
PATENT
DATE
CODES
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI

N 022426 001 6890898
Feb 02, 2019
U-1335

7078381
Feb 02, 2019
U-1335

7459428
Feb 02, 2019
U-1336

7807689
Jun 27, 2028
DS DP U-1337

8173663
Mar 15, 2025
U-1338

8288539
Mar 15, 2025
DS

8637079
Jun 04, 2029
DP

PATENT NO

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI

N 022426 002 5965584
Jun 19, 2016
DP U-1339
6150383
Jun 19, 2016
U-1330
6150384
Jun 19, 2016
U-1340

6166042
Jun 19, 2016
U-1341

6166043
Jun 19, 2016
U-1342

6172090
Jun 19, 2016
U-1343

6211205
Jun 19, 2016
U-1331

6271243
Jun 19, 2016
U-1344

6303640
Aug 09, 2016
U-1332

6303661
Apr 24, 2017
U-1333

6329404
Jun 19, 2016
DP U-1334

6890898
Feb 02, 2019
U-1335

7078381
Feb 02, 2019
U-1335

7459428
Feb 02, 2019
U-1336

7807689
Jun 27, 2028
DS DP U-1337

8173663
Mar 15, 2025
U-1338

8288539
Mar 15, 2025
DS

8637079
Jun 04, 2029
DP

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI

N 022426 003 5965584
Jun 19, 2016
DP U-1339
6150383
Jun 19, 2016
U-1330
6150384
Jun 19, 2016
U-1340

6166042
Jun 19, 2016
U-1341

6166043
Jun 19, 2016
U-1342

6172090
Jun 19, 2016
U-1343

6211205
Jun 19, 2016
U-1331

6271243
Jun 19, 2016
U-1344

6303640
Aug 09, 2016
U-1332

6303661
Apr 24, 2017
U-1333

6329404
Jun 19, 2016
DP U-1334

6890898
Feb 02, 2019
U-1335

7078381
Feb 02, 2019
U-1335

7459428
Feb 02, 2019
U-1336

7807689
Jun 27, 2028
DS DP U-1337

8173663
Mar 15, 2025
U-1338

8288539
Mar 15, 2025
DS

8637079
Jun 04, 2029
DP

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI

N 022426 004 5965584
Jun 19, 2016
DP U-1339
6150383
Jun 19, 2016
U-1330
6150384
Jun 19, 2016
U-1340

6166042
Jun 19, 2016
U-1341

6166043
Jun 19, 2016
U-1342

6172090
Jun 19, 2016
U-1343

6211205
Jun 19, 2016
U-1331

6271243
Jun 19, 2016
U-1344

6303640
Aug 09, 2016
U-1332

6303661
Apr 24, 2017
U-1333

6329404
Jun 19, 2016
DP U-1334

6890898
Feb 02, 2019
U-1335

7078381
Feb 02, 2019
U-1335

7459428
Feb 02, 2019
U-1336

7807689
Jun 27, 2028
DS DP U-1337

8173663
Mar 15, 2025
U-1338

8288539
Mar 15, 2025
DS

8637079
Jun 04, 2029
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NC
NCE

Jan 25, 2016

Jan 25, 2018

NC
NCE

Jan 25, 2016

Jan 25, 2018

NC
NCE

Jan 25, 2016

Jan 25, 2018

ADA 8 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
PATENT
DATE
CODES
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI

N 022426 005 5965584
Jun 19, 2016
DP U-1339
6150383
Jun 19, 2016
U-1330
6150384
Jun 19, 2016
U-1340

6166042
Jun 19, 2016
U-1341

6166043
Jun 19, 2016
U-1342

6172090
Jun 19, 2016
U-1343

6211205
Jun 19, 2016
U-1331

6271243
Jun 19, 2016
U-1344

6303640
Aug 09, 2016
U-1332

6303661
Apr 24, 2017
U-1333

6329404
Jun 19, 2016
DP U-1334

6890898
Feb 02, 2019
U-1335

7078381
Feb 02, 2019
U-1335

7459428
Feb 02, 2019
U-1336

7807689
Jun 27, 2028
DS DP U-1337

8173663
Mar 15, 2025
U-1338

8288539
Mar 15, 2025
DS

8637079
Jun 04, 2029
DP

PATENT NO

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI

N 022426 006 5965584
Jun 19, 2016
DP U-1339
6150383
Jun 19, 2016
U-1330
6150384
Jun 19, 2016
U-1340

6166042
Jun 19, 2016
U-1341

6166043
Jun 19, 2016
U-1342

6172090
Jun 19, 2016
U-1343

6211205
Jun 19, 2016
U-1331

6271243
Jun 19, 2016
U-1344

6303640
Aug 09, 2016
U-1332

6303661
Apr 24, 2017
U-1333

6329404
Jun 19, 2016
DP U-1334

6890898
Feb 02, 2019
U-1335

7078381
Feb 02, 2019
U-1335

7459428
Feb 02, 2019
U-1336

7807689
Jun 27, 2028
DS DP U-1337

8173663
Mar 15, 2025
U-1338

8288539
Mar 15, 2025
DS

8637079
Jun 04, 2029
DP

ALOSETRON HYDROCHLORIDE - LOTRONEX

N 021107 001 6284770
Oct 05, 2018

U-405

ALOSETRON HYDROCHLORIDE - LOTRONEX

N 021107 002 6284770
Oct 05, 2018

U-405

ALPRAZOLAM - NIRAVAM

N 021726 001 6024981
6221392

Apr 09, 2018

Apr 09, 2018

DP

DP

ALPRAZOLAM - NIRAVAM

N 021726 002 6024981
6221392

Apr 09, 2018

Apr 09, 2018

DP

DP

ALPRAZOLAM - NIRAVAM

N 021726 003 6024981
6221392

Apr 09, 2018

Apr 09, 2018

DP

DP

ALPRAZOLAM - NIRAVAM

N 021726 004 6024981
6221392

Apr 09, 2018

Apr 09, 2018

DP

DP

ALPROSTADIL - MUSE

N 020700 001 5886039

Mar 23, 2016

DP U-155

ALPROSTADIL - MUSE

N 020700 002 5886039

Mar 23, 2016

DP U-155

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NC
NCE

Jan 25, 2016

Jan 25, 2018

NC
NCE

Jan 25, 2016

Jan 25, 2018

ADA 9 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ALPROSTADIL - MUSE
N 020700 003 5886039

Mar 23, 2016

DP U-155

ALPROSTADIL - MUSE
N 020700 004 5886039

Mar 23, 2016

DP U-155

ALVIMOPAN - ENTEREG
N 021775 001 5250542
6469030
8112290
8645160
8946262

Mar
Nov
Jul
Jun
Feb

29,
29,
31,
18,
12,

2016
2020
2030
2029
2030

DS DP U-878
U-879
U-1443
U-1485
U-1655

M-128

Oct 18, 2016

AMBRISENTAN - LETAIRIS
N 022081 001 5840722
5840722
7109205
7601730
8349843
8377933
RE42462

Nov
Nov
Oct
Oct
Oct
Dec
Jul

24,
24,
07,
07,
07,
11,
29,

2015
2015
2015
2015
2015
2027
2018

U-821
U-1297

I-716

Oct 02, 2018

AMBRISENTAN - LETAIRIS
N 022081 002 5840722
5840722
7109205
7601730
8349843
8377933
RE42462

Nov
Nov
Oct
Oct
Oct
Dec
Jul

24,
24,
07,
07,
07,
11,
29,

2015
2015
2015
2015
2015
2027
2018

I-716

Oct 02, 2018

AMIFOSTINE - ETHYOL
N 020221 001 5994409

Dec 08, 2017

U-305

AMIFOSTINE - ETHYOL
N 020221 002 5994409

Dec 08, 2017

U-305

AMINOLEVULINIC ACID HYDROCHLORIDE - LEVULAN

N 020965 001 5954703
Oct 31, 2017
6709446
May 01, 2018
7723910
Jun 17, 2019
8216289
May 01, 2018
8758418
May 01, 2018

U-289
U-289
U-289
U-289
U-289

PATENT NO

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS DP
U-1080
DS DP
U-1754
DS

U-821
U-1297
DS DP
U-1080
DS DP
U-1754
DS

AMIODARONE HYDROCHLORIDE - NEXTERONE

N 022325 001 6869939
May 04, 2022
7635773
Mar 13, 2029

DP
DP

AMIODARONE HYDROCHLORIDE - NEXTERONE

N 022325 002 6869939
May 04, 2022
7635773
Mar 13, 2029

DP
DP

AMIODARONE HYDROCHLORIDE - NEXTERONE

N 022325 003 6869939
May 04, 2022
7635773
Mar 13, 2029

DP
DP

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE

N 022026 001 6828339
Nov 20, 2022

DS

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE

N 022026 002 6828339
Nov 20, 2022

DS

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE

N 022026 003 6828339
Nov 20, 2022

DS

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 001 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 10 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
PATENT
DATE
CODES
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 002 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018
U-552
APPL/PROD
NO

PATENT NO

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 003 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 004 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 005 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 006 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 007 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 008 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 009 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 010 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N 021540 011 5969156
Jul 08, 2016
DS
6455574
Aug 11, 2018

U-552

PATENT
DELIST
REQUESTED

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL

N 020364 002 6162802
Dec 19, 2017
U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 003 6162802
Dec 19, 2017
U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 004 6162802
Dec 19, 2017
U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 005 6162802
Dec 19, 2017
U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 006 6162802
Dec 19, 2017
DS DP U-185
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 007 6162802
Dec 19, 2017
DS DP U-185
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 001 5616599
Apr 25, 2016
DS DP U-3
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 002 5616599
Apr 25, 2016
DS DP U-3
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 003 5616599
Apr 25, 2016
DS DP U-3
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 004 5616599
Apr 25, 2016
DS DP U-3

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 11 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
PATENT
EXPIRATION
DELIST
PATENT
DATE
REQUESTED
CODES
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 005 5616599
Apr 25, 2016
DS DP U-3
APPL/PROD
NO

PATENT NO

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

N 022314 001 6294197
Jun 18, 2017
8101599
May 16, 2023
8475839
May 16, 2023
8475839*PED
Nov 16, 2023

- EXFORGE HCT
DP U-3
DP
DP

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

N 022314 002 6294197
Jun 18, 2017
8101599
May 16, 2023
8475839
May 16, 2023
8475839*PED
Nov 16, 2023

- EXFORGE HCT
DP U-3
DP
DP

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

N 022314 003 6294197
Jun 18, 2017
8101599
May 16, 2023
8475839
May 16, 2023
8475839*PED
Nov 16, 2023

- EXFORGE HCT
DP U-3
DP
DP

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

N 022314 004 6294197
Jun 18, 2017
8101599
May 16, 2023
8475839
May 16, 2023
8475839*PED
Nov 16, 2023

- EXFORGE HCT
DP U-3
DP
DP

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

N 022314 005 6294197
Jun 18, 2017
8101599
May 16, 2023
8475839
May 16, 2023
8475839*PED
Nov 16, 2023

- EXFORGE HCT
DP U-3
DP
DP

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR

N 022100 001 5616599
Apr 25, 2016
DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 002 5616599
Apr 25, 2016
DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 003 5616599
Apr 25, 2016
DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 004 5616599
Apr 25, 2016
DS DP U-3
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE - PRESTALIA
N 205003 001 6696481
Apr 15, 2023
DS DP U-3
7846961
Oct 05, 2029
DS DP U-3
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE - PRESTALIA
N 205003 002 6696481
Apr 15, 2023
DS DP U-3
7846961
Oct 05, 2029
DS DP U-3
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE - PRESTALIA
N 205003 003 6696481
Apr 15, 2023
DS DP U-3
7846961
Oct 05, 2029
DS DP U-3
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 002 6294197
Jun 18, 2017
6395728
Jul 08, 2019

DP U-3
DP

AMLODIPINE BESYLATE; VALSARTAN - EXFORGE

N 021990 003 6294197
Jun 18, 2017
6395728
Jul 08, 2019

DP U-3
DP

AMLODIPINE BESYLATE; VALSARTAN - EXFORGE

N 021990 004 6294197
Jun 18, 2017
6395728
Jul 08, 2019

DP U-3
DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 12 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 005 6294197
Jun 18, 2017
6395728
Jul 08, 2019
PATENT NO

AMOXICILLIN - MOXATAG
N 050813 001 6544555
6669948
6723341
8299052
8357394
8778924

Oct
Oct
Oct
May
Dec
Dec

13,
13,
13,
07,
08,
08,

2020
2020
2020
2027
2026
2026

AMOXICILLIN; CLAVULANATE POTASSIUM N 050785 001 6746692

Apr
6783773
Apr
6878386
Apr
7217430
Apr
7250176
Apr

AUGMENTIN XR
04, 2020
04, 2020
04, 2020
04, 2020
04, 2020

AMPHETAMINE - DYANAVEL XR
N 208147 001 8062667
8597684
8747902
8883217

29,
15,
15,
15,

Mar
Mar
Mar
Mar

2029
2027
2027
2027

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-3
DP

DS DP U-897
DS DP U-897
DS DP U-897
U-1304
DP
DS DP U-897

DP
DP
U-926
DP U-926
U-926

DP
DP
DP
DP

NP

Oct 19, 2018

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 10

N 011522 007 6384020
Jul 06, 2020

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 20

N 011522 008 6384020
Jul 06, 2020

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 5

N 011522 009 6384020
Jul 06, 2020

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 30

N 011522 010 6384020
Jul 06, 2020

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 7.5

N 011522 011 6384020
Jul 06, 2020

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 12.5

N 011522 012 6384020
Jul 06, 2020

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 15

N 011522 013 6384020
Jul 06, 2020

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 10

N 021303 001 6322819
Oct 21, 2018

6605300
Oct 21, 2018

RE41148
Oct 21, 2018
DP

RE42096
Oct 21, 2018
DP

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 20

N 021303 002 6322819
Oct 21, 2018

6605300
Oct 21, 2018

RE41148
Oct 21, 2018
DP

RE42096
Oct 21, 2018
DP

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 30

N 021303 003 6322819
Oct 21, 2018
6605300
Oct 21, 2018
RE41148
Oct 21, 2018
DP
RE42096
Oct 21, 2018
DP

ADA 13 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
PATENT
EXCLUSIVITY

EXPIRATION
DELIST
EXPIRATION

PATENT
EXCLUSIVITY
DATE
REQUESTED
DATE

CODES
CODE(S)
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 30

N 021303 003 6322819
Oct 21, 2018

6605300
Oct 21, 2018

RE41148
Oct 21, 2018
DP

RE42096
Oct 21, 2018
DP

PATENT NO

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 25

N 021303 004 6322819
Oct 21, 2018

6605300
Oct 21, 2018

RE41148
Oct 21, 2018
DP

RE42096
Oct 21, 2018
DP

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 5

N 021303 005 6322819
Oct 21, 2018

6605300
Oct 21, 2018

RE41148
Oct 21, 2018
DP

RE42096
Oct 21, 2018
DP

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 15

N 021303 006 6322819
Oct 21, 2018

6605300
Oct 21, 2018

RE41148
Oct 21, 2018
DP

RE42096
Oct 21, 2018
DP

AMPHOTERICIN B - ABELCET

N 050724 001 6406713

Jun 18, 2019

AMPHOTERICIN B - AMBISOME

N 050740 001 5874104
5965156

Feb 23, 2016

Oct 12, 2016

DP U-922

DP U-922

AMPRENAVIR - AGENERASE

N 021007 001 6730679

Nov 11, 2017

DP

AMPRENAVIR - AGENERASE

N 021007 002 6730679

Nov 11, 2017

DP

ANIDULAFUNGIN - ERAXIS

N 021632 001 5965525
6960564
7709444

Feb 17, 2020

Apr 12, 2021
Apr 12, 2021

DS DP U-540

DP U-540

DP U-540

ANIDULAFUNGIN - ERAXIS

N 021632 002 5965525
6960564
7709444

Feb 17, 2020

Apr 12, 2021
Apr 12, 2021

DS DP U-540

DP U-540

DP U-540

APIXABAN - ELIQUIS

N 202155 001 6413980
6413980
6413980
6413980
6967208
6967208
6967208
6967208
6967208
6967208
6967208
6967208
6967208

Dec
Dec
Dec
Dec
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

22,
22,
22,
22,
03,
03,
03,
03,
03,
03,
03,
03,
03,

2019
2019
2019
2019
2023
2023
2023
2023
2023
2023
2023
2023
2023

DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-1200
U-1301
U-1302
U-1501
U-1167
U-1200
U-1301
U-1302
U-1323
U-1501
U-1502
U-1729
U-1730

I-661
I-681
I-690
I-691
NCE

Aug
Mar
Aug
Aug
Dec

21,
03,
21,
21,
28,

2017
2017
2017
2017
2017

APIXABAN - ELIQUIS

N 202155 002 6413980
6413980
6413980
6967208

Dec
Dec
Dec
Feb

22,
22,
22,
03,

2019
2019
2019
2023

DS
DS
DS
DS

DP
DP
DP
DP

U-1200
U-1301
U-1302
U-1200

I-661
I-690
I-691
NCE

Aug
Aug
Aug
Dec

21,
21,
21,
28,

2017

2017

2017

2017

DS

ADA 14 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

APIXABAN - ELIQUIS

N 202155 002 6967208
6967208
6967208

Feb 03, 2023

Feb 03, 2023
Feb 03, 2023

DS DP U-1301

DS DP U-1302

DS DP U-1323

APREMILAST - OTEZLA

N 205437 001 6020358
6962940
7208516
7427638
7659302
7659302
7893101
8455536
8455536
8802717
9018243
9018243

Oct
Mar
Mar
Nov
Mar
Mar
Dec
Mar
Mar
Mar
Mar
Mar

30,
19,
19,
17,
19,
19,
09,
19,
19,
19,
19,
19,

2018
2023
2023
2024
2023
2023
2023
2023
2023
2023
2023
2023

DS DP U-1504
U-1504
U-1505

DS DP

U-1505

U-1595

DS DP

U-1505

U-1595

U-1561

U-1505

U-1595

I-694
NCE

Sep 23, 2017

Mar 21, 2019

APREMILAST - OTEZLA

N 205437 002 6020358
6962940
7208516
7427638
7659302
7659302
7893101
8455536
8455536
8802717
9018243
9018243

Oct
Mar
Mar
Nov
Mar
Mar
Dec
Mar
Mar
Mar
Mar
Mar

30,
19,
19,
17,
19,
19,
09,
19,
19,
19,
19,
19,

2018
2023
2023
2024
2023
2023
2023
2023
2023
2023
2023
2023

DS DP U-1504
U-1504
U-1505

DS DP

U-1505

U-1595

DS DP

U-1505

U-1595

U-1561

U-1505

U-1595

I-694
NCE

Sep 23, 2017

Mar 21, 2019

APREMILAST - OTEZLA

N 205437 003 6020358
6962940
7208516
7427638
7659302
7659302
7893101
8455536
8455536
8802717
9018243
9018243

Oct
Mar
Mar
Nov
Mar
Mar
Dec
Mar
Mar
Mar
Mar
Mar

30,
19,
19,
17,
19,
19,
09,
19,
19,
19,
19,
19,

2018
2023
2023
2024
2023
2023
2023
2023
2023
2023
2023
2023

DS DP U-1504
U-1504
U-1505

DS DP

U-1505

U-1595

DS DP

U-1505

U-1595

U-1561

U-1505

U-1595

I-694
NCE

Sep 23, 2017

Mar 21, 2019

APREPITANT - EMEND

N 021549 001 6096742
6096742
6096742
8258132
8258132

Jul
Jul
Jul
Sep
Sep

01,
01,
01,
26,
26,

2018
2018
2018
2027
2027

DS DP U-745
DS DP U-1743

DS DP U-1744

DP U-901

DP U-1743

NPP

Aug 28, 2018

APREPITANT - EMEND

N 021549 002 6096742
6096742
6096742
8258132
8258132

Jul
Jul
Jul
Sep
Sep

01,
01,
01,
26,
26,

2018
2018
2018
2027
2027

DS DP U-745
DS DP U-1743

DS DP U-1744

DP U-901

DP U-1743

NPP

Aug 28, 2018

APREPITANT - EMEND
N 021549 003 6096742
6096742
6096742
8258132
8258132

Jul
Jul
Jul
Sep
Sep

01,
01,
01,
26,
26,

2018
2018
2018
2027
2027

DS DP U-745
DS DP U-1743
DS DP U-1744
DP U-901
DP U-1743

NPP

Aug 28, 2018

ADA 15 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

APREPITANT - EMEND
N 207865 001
ARFORMOTEROL TARTRATE - BROVANA
N 021912 001 6040344
6472563
6667344
6720453
6814953
7145036
7348362
7462645
7465756
7473710
7541385
8110706

Nov
Nov
Jun
Nov
Jun
Nov
Jun
Jun
Jun
Jun
Jun
Nov

12,
09,
22,
09,
22,
09,
22,
22,
22,
22,
22,
09,

2016
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021
2021

Jan
Jun
Dec
Sep
Mar
Jan
Jul
Sep
Mar
Mar
Jan
Jul

28,
16,
16,
25,
25,
28,
28,
25,
25,
02,
28,
28,

2022
2024
2024
2022
2023
2022
2022
2022
2023
2027
2022
2026

ARIPIPRAZOLE - ABILIFY
N 021436 002 7053092
8017615
8017615*PED
8580796
8580796*PED
8642600
8642600*PED
8642760
8642760*PED
8759350
9089567
9125939

Jan
Jun
Dec
Sep
Mar
Jan
Jul
Sep
Mar
Mar
Jan
Jul

28,
16,
16,
25,
25,
28,
28,
25,
25,
02,
28,
28,

2022
2024
2024
2022
2023
2022
2022
2022
2023
2027
2022
2026

ARIPIPRAZOLE - ABILIFY
N 021436 003 7053092
8017615
8017615*PED
8580796
8580796*PED
8642600
8642600*PED
8642760
8642760*PED
8759350
9089567
9125939

Jan
Jun
Dec
Sep
Mar
Jan
Jul
Sep
Mar
Mar
Jan
Jul

28,
16,
16,
25,
25,
28,
28,
25,
25,
02,
28,
28,

2022
2024
2024
2022
2023
2022
2022
2022
2023
2027
2022
2026

ARIPIPRAZOLE - ABILIFY
N 021436 004 7053092
8017615
8017615*PED
8580796
8580796*PED
8642600

Jan
Jun
Dec
Sep
Mar
Jan

28,
16,
16,
25,
25,
28,

2022
2024
2024
2022
2023
2022

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NPP

Aug 28, 2018

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

DS
DS
DP
DS
U-793
DS
DP U-793
U-793
DP
U-793
U-793
DP

ARGATROBAN - ARGATROBAN IN SODIUM CHLORIDE

N 022434 001 7589106
Sep 26, 2027
7687516
Sep 26, 2027
ARIPIPRAZOLE - ABILIFY
N 021436 001 7053092
8017615
8017615*PED
8580796
8580796*PED
8642600
8642600*PED
8642760
8642760*PED
8759350
9089567
9125939

PATENT
DELIST
REQUESTED

DP U-1163
DP U-1164

U-839
DP
DS
U-1492
DS
U-1529
U-543
U-1749

U-839
DP
DS
U-1492
DS
U-1529
U-543
U-1749

U-839
DP
DS
U-1492
DS
U-1529
U-543
U-1749

U-839
DP
DS
U-1492

ADA 16 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD

NO

PATENT NO

PATENT

EXPIRATION

DATE

ARIPIPRAZOLE - ABILIFY

N 021436 004 8642600*PED

8642760

8642760*PED

8759350

9089567

9125939

Jul
Sep
Mar
Mar
Jan
Jul

28,
25,
25,
02,
28,
28,

2022

2022

2023

2027

2022

2026

ARIPIPRAZOLE - ABILIFY

N 021436 005 7053092

8017615

8017615*PED

8580796

8580796*PED

8642600

8642600*PED

8642760

8642760*PED

8759350

9089567

9125939

Jan
Jun
Dec
Sep
Mar
Jan
Jul
Sep
Mar
Mar
Jan
Jul

28,
16,
16,
25,
25,
28,
28,
25,
25,
02,
28,
28,

2022

2024

2024

2022

2023

2022

2022

2022

2023

2027

2022

2026

ARIPIPRAZOLE - ABILIFY

N 021436 006 7053092

8017615

8017615*PED

8580796

8580796*PED

8642600

8642600*PED

8642760

8642760*PED

8759350

9089567

9125939

Jan
Jun
Dec
Sep
Mar
Jan
Jul
Sep
Mar
Mar
Jan
Jul

28,
16,
16,
25,
25,
28,
28,
25,
25,
02,
28,
28,

2022

2024

2024

2022

2023

2022

2022

2022

2023

2027

2022

2026

ARIPIPRAZOLE - ABILIFY

N 021713 001 6977257

6977257*PED

7053092

8642600

8642600*PED

8759350

Apr
Oct
Jan
Jan
Jul
Mar

24,
24,
28,
28,
28,
02,

2022

2022

2022

2022

2022

2027

ARIPIPRAZOLE - ABILIFY

N 021729 002 7053092

8017615

8017615*PED

8518421

8518421*PED

8580796

8580796*PED

8642600

8642600*PED

8642760

8642760*PED

8759350

9089567

9125939

Jan
Jun
Dec
Jan
Jul
Sep
Mar
Jan
Jul
Sep
Mar
Mar
Jan
Jul

28,
16,
16,
24,
24,
25,
25,
28,
28,
25,
25,
02,
28,
28,

2022

2024

2024

2021

2021

2022

2023

2022

2022

2022

2023

2027

2022

2026

ARIPIPRAZOLE - ABILIFY

N 021729 003 7053092

8017615

8017615*PED

8518421

8518421*PED

8580796

8580796*PED

8642600

8642600*PED

Jan
Jun
Dec
Jan
Jul
Sep
Mar
Jan
Jul

28,
16,
16,
24,
24,
25,
25,
28,
28,

2022

2024

2024

2021

2021

2022

2023

2022

2022

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS
U-1529
U-543
U-1749

U-839
DP

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017
Dec 12, 2021

DS
U-1492
DS
U-1529
U-543
U-1749

U-839
DP
DS
U-1492
DS
U-1529
U-543
U-1749

DP
U-839
U-1492
U-1529

U-839
DP
DP
DS
U-1492
DS
U-1529
U-543
U-1749

U-839
DP
DP
DS
U-1492

ADA 17 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD

NO

PATENT NO

PATENT

EXPIRATION

DATE

ARIPIPRAZOLE - ABILIFY

N 021729 003 8642760

8642760*PED

8759350

9089567

9125939

Sep
Mar
Mar
Jan
Jul

25,
25,
02,
28,
28,

2022

2023

2027

2022

2026

ARIPIPRAZOLE - ABILIFY

N 021729 004 7053092

8017615

8017615*PED

8518421

8518421*PED

8580796

8580796*PED

8642600

8642600*PED

8642760

8642760*PED

Jan
Jun
Dec
Jan
Jul
Sep
Mar
Jan
Jul
Sep
Mar

28,
16,
16,
24,
24,
25,
25,
28,
28,
25,
25,

2022

2024

2024

2021

2021

2022

2023

2022

2022

2022

2023

ARIPIPRAZOLE - ABILIFY

N 021729 005 7053092

8017615

8017615*PED

8518421

8518421*PED

8580796

8580796*PED

8642600

8642600*PED

8642760

8642760*PED

Jan
Jun
Dec
Jan
Jul
Sep
Mar
Jan
Jul
Sep
Mar

28,
16,
16,
24,
24,
25,
25,
28,
28,
25,
25,

2022

2024

2024

2021

2021

2022

2023

2022

2022

2022

2023

ARIPIPRAZOLE - ABILIFY

N 021866 001 7115587

7115587*PED

7550445

Jul 21, 2024

Jan 21, 2025

Jul 21, 2024

ARIPIPRAZOLE - ABILIFY MAINTENA KIT

N 202971 001 7807680
Oct 19, 2024

8030313
Oct 19, 2024

8030313
Oct 19, 2024

8338427
Mar 15, 2025

8338427
Mar 15, 2025

8338428
Aug 06, 2023

8338428
Aug 06, 2023

8399469
Jun 29, 2025

8722679
Oct 19, 2024

8759351
Aug 06, 2023

8759351
Aug 06, 2023

8993761
Sep 25, 2022

9089567
Jan 28, 2022

ARIPIPRAZOLE - ABILIFY MAINTENA KIT

N 202971 002 7807680
Oct 19, 2024

8030313
Oct 19, 2024

8030313
Oct 19, 2024

8338427
Mar 15, 2025

8338427
Mar 15, 2025

8338428
Aug 06, 2023

8338428
Aug 06, 2023

8399469
Jun 29, 2025

8722679
Oct 19, 2024

8759351
Aug 06, 2023

8759351
Aug 06, 2023

8993761
Sep 25, 2022

9089567
Jan 28, 2022

PATENT
CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DS

U-1529

U-543

U-1749

U-839

DP

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017

Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017

Dec 12, 2021

I-700
M-137
ODE

Dec 12, 2017

Jun 09, 2017

Dec 12, 2021

M-150
NDF

Dec 05, 2017

Feb 28, 2016

M-150
NDF

Dec 05, 2017

Feb 28, 2016

DP

DS

U-1492

DS

U-839

DP

DP

DS

U-1492

DS

DP U-764

DP

DP

DP
DP
DP
DP

U-543
U-1632
U-543
U-1633
U-543
U-1633

DS
DP
DP U-1530
DP U-1633
DS
U-543

DP

DP
DP
DP
DP

U-543
U-1632
U-543
U-1633
U-543
U-1633

DS
DP
DP U-1530
DP U-1633
DS
U-543

ADA 18 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 003 7807680
Oct 19, 2024
8030313
Oct 19, 2024
8030313
Oct 19, 2024
8338427
Mar 15, 2025
8338427
Mar 15, 2025
8338428
Aug 06, 2023
8338428
Aug 06, 2023
8399469
Jun 29, 2025
8722679
Oct 19, 2024
8759351
Aug 06, 2023
8759351
Aug 06, 2023
8993761
Sep 25, 2022
9089567
Jan 28, 2022
APPL/PROD
NO

PATENT NO

ARIPIPRAZOLE - ABILIFY MAINTENA KIT

N 202971 004 7807680
Oct
8030313
Oct
8030313
Oct
8338427
Mar
8338427
Mar
8338428
Aug
8338428
Aug
8399469
Jun
8722679
Oct
8759351
Aug
8759351
Aug
8993761
Sep
9089567
Jan

19,
19,
19,
15,
15,
06,
06,
29,
19,
06,
06,
25,
28,

2024
2024
2024
2025
2025
2023
2023
2025
2024
2023
2023
2022
2022

ARIPIPRAZOLE LAUROXIL - ARISTADA

N 207533 001 8431576
Oct 26, 2030
8796276
Jun 24, 2030
9034867
Nov 07, 2032
9193685
Oct 24, 2033
ARIPIPRAZOLE LAUROXIL - ARISTADA
N 207533 002 8431576
Oct 26, 2030
8796276
Jun 24, 2030
9034867
Nov 07, 2032
9193685
Oct 24, 2033
ARIPIPRAZOLE LAUROXIL - ARISTADA
N 207533 003 8431576
Oct 26, 2030
8796276
Jun 24, 2030
9034867
Nov 07, 2032
9193685
Oct 24, 2033

PATENT
CODES
DP

DP
DP
DP
DP

U-543
U-1632
U-543
U-1633
U-543
U-1633

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-150
NDF

Dec 05, 2017

Feb 28, 2016

M-150
NDF

Dec 05, 2017

Feb 28, 2016

NCE

Oct 05, 2020

NCE

Oct 05, 2020

NCE

Oct 05, 2020

DS
DP
DP U-1530
DP U-1633
DS
U-543

DP

DP
DP
DP
DP

U-543
U-1632
U-543
U-1633
U-543
U-1633

DS
DP
DP U-1530
DP U-1633
DS
U-543

DS
U-543
DP U-543
DP U-543

DS
U-543
DP U-543
DP U-543

DS
U-543
DP U-543
DP U-543

ARMODAFINIL - NUVIGIL
N 021875 001 7132570
7297346

Dec 18, 2023

Nov 29, 2023

DS DP
DP

ARMODAFINIL - NUVIGIL
N 021875 002 7132570
7297346

Dec 18, 2023

Nov 29, 2023

DS DP
DP

ARMODAFINIL - NUVIGIL
N 021875 003 7132570
7297346

Dec 18, 2023

Nov 29, 2023

DS DP
DP

ARMODAFINIL - NUVIGIL
N 021875 004 7132570
7297346

Dec 18, 2023

Nov 29, 2023

DS DP
DP

ARMODAFINIL - NUVIGIL
N 021875 005 7132570
7297346

Dec 18, 2023

Nov 29, 2023

DS DP
DP

ADA 19 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

ARSENIC TRIOXIDE - TRISENOX

N 021248 001 6723351
6855339
6861076
6884439
6982096
8273379

PATENT
EXPIRATION
DATE
Nov
Nov
Nov
Nov
Nov
Nov

10,
10,
10,
10,
10,
10,

PATENT
CODES

2018
2018
2018
2018
2018
2018

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-573

U-617

U-617

U-651

U-651

U-1291

ARTEMETHER; LUMEFANTRINE - COARTEM

N 022268 001

ODE

Apr 07, 2016

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM

SULFATE - MOVIPREP

N 021881 001 7169381
Sep 01, 2024
DS DP

7658914
Sep 01, 2024
DS DP

ASENAPINE MALEATE - SAPHRIS

N 022117 001 5763476
5763476*PED
7741358
7741358*PED
8022228
8022228*PED

Jun
Dec
Apr
Oct
Apr
Oct

09,
09,
06,
06,
06,
06,

2020
2020
2026
2026
2026
2026

ASENAPINE MALEATE - SAPHRIS

N 022117 002 5763476
5763476*PED
7741358
7741358*PED
8022228
8022228*PED

Jun
Dec
Apr
Oct
Apr
Oct

09,
09,
06,
06,
06,
06,

2020
2020
2026
2026
2026
2026

ASPIRIN - ASPIRIN

N 203697 001 8865187
9101637
9101637
9101637

Mar
Mar
Mar
Mar

23,
23,
23,
23,

2022
2022
2022
2022

DP U-326
DS DP U-1064

M-158
NPP
PED
PED

Mar
Mar
Sep
Sep

17,
17,
17,
17,

2018

2018

2018

2018

M-158
NPP
PED
PED

Mar
Mar
Sep
Sep

17,
17,
17,
17,

2018

2018

2018

2018

NP
NPP
PED
PED

Jun
Sep
Dec
Mar

02,
24,
02,
24,

2017

2018

2017

2019

DS DP

DP U-326
DS DP U-1064
DS DP

DP

U-1731

U-1732

U-1733

ASPIRIN; DIPYRIDAMOLE - AGGRENOX

N 020884 001 6015577
Jan 18, 2017

U-302

ATAZANAVIR SULFATE - REYATAZ

N 021567 001 5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017

2018
2019

DS DP U-167

ATAZANAVIR SULFATE - REYATAZ

N 021567 002 5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017

2018
2019

DS DP U-167

ATAZANAVIR SULFATE - REYATAZ

N 021567 003 5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017

2018
2019

DS DP U-167

ATAZANAVIR SULFATE - REYATAZ

N 021567 004 5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017

2018
2019

DS DP U-167

ATAZANAVIR SULFATE - REYATAZ

N 206352 001 5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017
2018
2019

DS DP U-167

DS DP

DS DP

DS DP

DS DP

DS DP

ADA 20 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
ATAZANAVIR SULFATE; COBICISTAT - EVOTAZ
N 206353 001 5849911
Jun 20, 2017
5849911*PED
Dec 20, 2017
6087383
Dec 21, 2018
6087383*PED
Jun 21, 2019
8148374
Sep 03, 2029
APPL/PROD
NO

PATENT NO

PATENT
CODES

DS DP U-1279

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N 021411 002 5658590
Nov 26, 2016

U-494

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N 021411 003 5658590
Nov 26, 2016

U-494

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N 021411 004 5658590
Nov 26, 2016

U-494

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N 021411 005 5658590
Nov 26, 2016

U-494

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N 021411 006 5658590
Nov 26, 2016

U-494

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N 021411 007 5658590
Nov 26, 2016

U-494

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N 021411 008 5658590
Nov 26, 2016

U-494

ATORVASTATIN CALCIUM - LIPITOR

N 020702 001 5969156

Jul 08, 2016

DS

ATORVASTATIN CALCIUM - LIPITOR

N 020702 002 5969156

Jul 08, 2016

DS

ATORVASTATIN CALCIUM - LIPITOR

N 020702 003 5969156

Jul 08, 2016

DS

ATORVASTATIN CALCIUM - LIPITOR

N 020702 004 5969156

Jul 08, 2016

DS

ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET

N 200153 003 5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
RE42461
Oct 25, 2016
RE42461*PED
Apr 25, 2017
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 004 5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
RE42461
Oct 25, 2016
RE42461*PED
Apr 25, 2017
ATOVAQUONE - MEPRON
N 020500 001 6649659

Jul 10, 2016

EXCLUSIVITY
EXPIRATION
DATE

DS DP

U-494

ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET

N 200153 002 5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
RE42461
Oct 25, 2016
RE42461*PED
Apr 25, 2017

EXCLUSIVITY
CODE(S)

DS DP U-167

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N 021411 001 5658590
Nov 26, 2016

ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET

N 200153 001 5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
RE42461
Oct 25, 2016
RE42461*PED
Apr 25, 2017

PATENT
DELIST
REQUESTED

DS

NC

May 03, 2016

NC

May 03, 2016

NC

May 03, 2016

NC

May 03, 2016

DS DP U-1400

DS
DS DP U-1400

DS
DS DP U-1400

DS
DS DP U-1400

DS DP U-69

ADA 21 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

AVANAFIL - STENDRA
N 202276 001 6656935
7501409

Sep 13, 2020

May 05, 2023

DS DP U-155
DP

D-140
NCE

Sep 17, 2017

Apr 27, 2017

AVANAFIL - STENDRA
N 202276 002 6656935
7501409

Sep 13, 2020

May 05, 2023

DS DP U-155
DP

D-140
NCE

Sep 17, 2017

Apr 27, 2017

AVANAFIL - STENDRA
N 202276 003 6656935
7501409

Sep 13, 2020

May 05, 2023

DS DP U-155
DP

D-140
NCE

Sep 17, 2017

Apr 27, 2017

NCE

Jan 27, 2017

NCE

Jan 27, 2017

NP

Jul 29, 2018

M-129
NPP
NPP
NPP

Aug
Aug
Feb
Feb

M-129
NPP

Aug 30, 2016

Aug 30, 2016

NPP

Feb 20, 2018

NCE

Feb 25, 2016

NCE

Feb 25, 2016

AVIBACTAM SODIUM; CEFTAZIDIME - AVYCAZ

N 206494 001 7112592
Feb 24,
7612087
Nov 12,
8178554
Jul 24,
8471025
Aug 12,
8835455
Oct 08,
8969566
Jun 15,

2022
2026
2021
2031
2030
2032

DS DP U-282
DP
DS DP U-282
DS
DP
DS

AXITINIB - INLYTA
N 202324 001 6534524
7141581
8791140

Jun 30, 2020

Jun 30, 2020
Aug 05, 2030

DS DP

AXITINIB - INLYTA
N 202324 002 6534524
7141581
8791140

Jun 30, 2020

Jun 30, 2020
Aug 05, 2030

DS DP

AZELAIC ACID - FINACEA

N 021470 001 6534070

Nov 18, 2018

AZELAIC ACID - FINACEA

N 207071 001 6730288
7700076
8435498
8722021
8900554
9211259

Sep
Sep
Mar
Oct
Oct
Jan

08,
18,
01,
24,
24,
26,

U-1220
DS

U-1220
DS

2019
2027
2024
2023
2023
2029

DP
DP
U-1727
DP
DP
U-1796

AZELASTINE HYDROCHLORIDE - ASTEPRO

N 022203 001 8071073
Jun 04, 2028
8518919
Nov 22, 2025

DP

AZELASTINE HYDROCHLORIDE - ASTEPRO

N 022203 002 8071073
Jun 04, 2028
8518919
Nov 22, 2025

DP

U-1430

U-1430

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE - DYMISTA

N 202236 001 8163723
Aug 29, 2023
U-77
8163723
Aug 29, 2023
U-81
8163723
Aug 29, 2023
U-644
8163723
Aug 29, 2023
U-707
8163723
Aug 29, 2023
U-1667
8168620
Feb 24, 2026
DP
AZILSARTAN KAMEDOXOMIL - EDARBI
N 200796 001 7157584
7572920
9066936

May 22, 2025

Jan 07, 2025
Mar 26, 2028

DS

AZILSARTAN KAMEDOXOMIL - EDARBI

N 200796 002 7157584
7572920
9066936

May 22, 2025

Jan 07, 2025
Mar 26, 2028

DS

30,
30,
20,
20,

2016
2016
2018
2018

DP U-3
DP

DP U-3
DP

ADA 22 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
CHLORTHALIDONE - EDARBYCLOR
May 22, 2025
DS
Jan 07, 2025
Mar 26, 2028
Feb 25, 2030

PATENT NO

AZILSARTAN KAMEDOXOMIL;
N 202331 001 7157584
7572920
9066936
9169238

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE N 202331 002 7157584

May 22,
7572920
Jan 07,
9066936
Mar 26,
9169238
Feb 25,

PATENT
CODES

EDARBYCLOR
2025
DS
2025
DP U-3
2028
DP
2030
DP

Jul 31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N 050710 001 6268489

Jul 31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N 050710 002 6268489

Jul 31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N 050711 001 6268489

Jul 31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N 050730 001 6268489

Jul 31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N 050733 001 6268489

Jul 31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N 050784 001 6268489

Jul 31, 2018

DS

AZITHROMYCIN - ZMAX
N 050797 001 6068859
6268489
6984403
7887844

May
Jul
Feb
Feb

30,
31,
14,
14,

2017
2018
2024
2024

AZITHROMYCIN - AZASITE
N 050810 001 6159458
6239113
6569443
6861411
7056893

Nov
Mar
Mar
Nov
Mar

04,
31,
31,
25,
31,

2017
2019
2019
2018
2019

DP U-709
U-709
DP U-709
U-709
DP U-709

AZTREONAM - CAYSTON
N 050814 001 7208141
7214364
7427633
8399496

Dec
Dec
Dec
Dec

20,
20,
20,
20,

2021
2021
2021
2021

DP U-1031
DP
DP U-1031
DP U-1377

BACLOFEN - KEMSTRO
N 021589 001 6024981
6221392

Apr 09, 2018

Apr 09, 2018

DP
DP

BACLOFEN - KEMSTRO
N 021589 002 6024981
6221392

Apr 09, 2018

Apr 09, 2018

DP
DP

BALSALAZIDE DISODIUM - COLAZAL

N 020610 001 7452872
7625884

Aug 24, 2026

Aug 24, 2026

BALSALAZIDE DISODIUM - GIAZO

N 022205 001 6197341
7452872
7625884
8497256

Mar
Aug
Aug
Jun

2018
2026
2026
2031

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Feb 25, 2016

NCE

Feb 25, 2016

ODE

Feb 22, 2017

DP U-3
DP
DP

AZITHROMYCIN - ZITHROMAX
N 050693 001 6268489

13,
24,
24,
23,

PATENT
DELIST
REQUESTED

DP
DS
DP U-282
DP

U-141
U-141

DP U-1229
U-1229
U-1229
U-1229

ADA 23 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
PATENT
DATE
CODES
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED - DUAVEE
N 022247 001 5998402
Apr 04, 2017
DS DP U-594
6479535
May 06, 2019
DP U-594
6479535
May 06, 2019
DP U-904
7138392
Apr 04, 2017
DS DP U-594
7683051
Mar 10, 2027
DS DP U-594
7683051
Mar 10, 2027
DS DP U-904
8815934
May 06, 2019
DP
PATENT NO

BECLOMETHASONE DIPROPIONATE - QVAR 80

N 020911 001 5776432
Jul 07, 2015
6446627
Dec 18, 2017

DP U-645
DP

BECLOMETHASONE DIPROPIONATE - QVAR 40

N 020911 002 5776432
Jul 07, 2015
6446627
Dec 18, 2017

DP U-645
DP

BECLOMETHASONE DIPROPIONATE - QNASL

N 202813 001 5776432
Jul 07, 2015
7780038
Jan 24, 2027

DP
DP

BECLOMETHASONE DIPROPIONATE - QNASL

N 202813 002 5776432
Jul 07, 2015
7780038
Jan 24, 2027

DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NP

Oct 03, 2016

NS

Dec 17, 2017

BEDAQUILINE FUMARATE - SIRTURO

N 204384 001 7498343
8546428

Oct 02, 2024

Mar 19, 2029

DS DP U-1321
DS DP U-1321

NCE
ODE

Dec 28, 2017

Dec 28, 2019

BELINOSTAT - BELEODAQ
N 206256 001 6888027
8835501

Sep 27, 2021

Oct 27, 2027

DS DP U-1544
DP

NCE
ODE

Jul 03, 2019

Jul 03, 2021

ODE
PED
PED

Oct 31, 2015

Sep 20, 2015
May 01, 2016

ODE
PED
PED

Oct 31, 2015

Sep 20, 2015
May 01, 2016

ODE
PED

Oct 31, 2015

May 01, 2016

BENDAMUSTINE HYDROCHLORIDE - TREANDA

N 022249 001 8436190
Oct 26, 2030
8436190*PED
Apr 26, 2031
8445524
Mar 26, 2029
8445524*PED
Sep 26, 2029
8609863
Jan 12, 2026
8609863*PED
Jul 12, 2026
8669279
Mar 26, 2029
8669279*PED
Sep 26, 2029
8791270
Jan 12, 2026
8791270*PED
Jul 12, 2026
8883836
Mar 26, 2029
8883836*PED
Sep 26, 2029
8895756
Jan 12, 2026
8895756*PED
Jul 12, 2026
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 002 8436190
Oct 26, 2030
8436190*PED
Apr 26, 2031
8445524
Mar 26, 2029
8445524*PED
Sep 26, 2029
8609863
Jan 12, 2026
8609863*PED
Jul 12, 2026
8669279
Mar 26, 2029
8669279*PED
Sep 26, 2029
8791270
Jan 12, 2026
8791270*PED
Jul 12, 2026
8883836
Mar 26, 2029
8883836*PED
Sep 26, 2029
8895756
Jan 12, 2026
8895756*PED
Jul 12, 2026
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 003 8344006
Sep 23, 2029
8344006*PED
Mar 23, 2030
8445524
Mar 26, 2029
8445524*PED
Sep 26, 2029

DP
DS DP U-1402
DP
DP U-1402
DP U-1542
DP U-1402
DP

DP
DS DP U-1402
DP
DP U-1402
DP U-1542
DP U-1402
DP

DP U-1402
DS

ADA 24 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
BENDAMUSTINE HYDROCHLORIDE - TREANDA

N 022249 003 8791270
Jan 12, 2026
8791270*PED
Jul 12, 2026

PATENT NO

BENDAMUSTINE HYDROCHLORIDE - TREANDA

N 022249 004 8344006
Sep 23,
8344006*PED
Mar 23,
8445524
Mar 26,
8445524*PED
Sep 26,
8791270
Jan 12,
8791270*PED
Jul 12,

2029
2030
2029
2029

2026
2026

BENDAMUSTINE HYDROCHLORIDE - BENDEKA

N 208194 001 8609707
Aug 11,
8791270
Jan 12,
8791270*PED
Jul 12,
9000021
Mar 15,
9034908
Mar 15,
9144568
Mar 15,

2031
2026
2026

2033
2033
2033

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP U-1542

DP U-1402

ODE
PED

Oct 31, 2015

May 01, 2016

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - ENSTILAR

N 207589 001 6753013
Jan 27, 2020
DP U-1761
9119781
Jun 10, 2031
DP U-1761

NP

Oct 16, 2018

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX

N 021852 001 6753013
Jan 27, 2020
DP U-88
6753013
Jan 27, 2020
DP U-193

NPP

Dec 23, 2017

I-659
NPP

Oct 17, 2015

Aug 29, 2017

DS

DP U-1542

DP U-1542

DP U-1790

U-1542

U-1542

U-1542

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA

N 050819 001 8288434
Aug 05, 2029
8663699
Jun 03, 2029
8895070
Jun 03, 2029
9078870
Jun 03, 2029

DP U-124

U-124

U-124

DP

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ONEXTON

N 050819 002 8288434
Aug 05, 2029
8288434
Aug 05, 2029
8288434
Aug 05, 2029
8288434
Aug 05, 2029
8288434
Aug 05, 2029
8288434
Aug 05, 2029

DP
DP
DP
DP
DP
DP

BENZYL ALCOHOL - ULESFIA

N 022129 001 5858383
6139859
6793931
7294342

Aug
Aug
Jul
May

U-970

U-970

DP U-970

U-970

BEPOTASTINE BESILATE - BEPREVE

N 022288 001 6780877
8784789
8877168

Sep 19, 2019

Sep 05, 2024
Jul 30, 2023

11,
11,
11,
19,

BESIFLOXACIN HYDROCHLORIDE - BESIVANCE

N 022308 001 5447926
Apr 13,
6685958
Jun 29,
6699492
Mar 31,
8415342
Nov 07,
8481526
Jan 09,
8604020
Mar 12,
8937062
Nov 13,

2017
2017
2022
2024

2016
2021
2019
2030
2031
2030
2029

U-124

U-134

U-818

U-916

U-921

U-1033

DS DP

DP

DP

DS DP U-80

DP U-80

DP U-80

U-80

DS

DP

U-80

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX

N 022185 001 6753013
Jan 27, 2020
DP U-88
6753013
Jan 27, 2020
DP U-193
6753013
Jan 27, 2020
DP U-1761

6787529
Jan 27, 2020
DP U-88

6787529
Jan 27, 2020
DP U-193

6787529
Jan 27, 2020
DP U-1761

ADA 25 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
PATENT
DATE
CODES
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX

N 022185 002 6753013
Jan 27, 2020
DP U-1761

6787529
Jan 27, 2020
DP U-1761

PATENT NO

BETAMETHASONE VALERATE - LUXIQ

N 020934 001 6126920
7078058

Mar 01, 2016

May 24, 2017

BEXAROTENE - TARGRETIN

N 021055 001 5780676
5962731

Jul 14, 2015

Oct 05, 2016

U-509
U-475

BEXAROTENE - TARGRETIN

N 021056 001 5780676
5962731

Jul 14, 2015

Oct 05, 2016

U-510

BIMATOPROST - LUMIGAN

N 022184 001 7851504
8278353
8299118
8309605
8309605
8338479
8524777
8586630
8772338
8933120
8933127
9155716

Jun
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

13,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,

2027
2025
2025
2025
2025
2025
2025
2025
2025
2025
2025
2025

DS DP

DP

BIMATOPROST - LATISSE

N 022369 001 7351404
7388029
8038988
8101161
8101161
8263054
8541466
8632760
8758733
8906962
8926953
8986715

May
Jan
Aug
May
May
Jan
Jan
Jan
Jan
Jan
Jan
Jan

25,
21,
25,
25,
25,
15,
31,
15,
15,
31,
15,
15,

2024
2022
2023
2024
2024
2023
2021
2023
2023
2021
2023
2023

U-939
U-938
DS DP U-1208

U-1217

U-1218

U-1277

U-1217

U-1487

U-1487

U-1217

U-1217

U-1217

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-484

DP

M-164

Jul 29, 2018

M-140

Sep 04, 2017

U-1295

U-1293

U-1294

DP U-1295

U-1235

U-1458

DP U-1528

DP

DP

DP U-1528

Y
Y

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - HALFLYTELY

N 021551 003 7291324
Oct 22, 2022
U-837

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE - PYLERA

N 050786 001 6350468
Dec 14, 2018
U-932

6350468
Dec 14, 2018
U-956

BIVALIRUDIN - ANGIOMAX

N 020873 001 7582727
7598343

Jul 27, 2028

Jul 27, 2028

BOCEPREVIR - VICTRELIS

N 202258 001 7772178
8119602
RE43298

Nov 11, 2027

Mar 17, 2027
Feb 22, 2022

DP U-1128
U-1233
DS DP U-1128

M-126
NCE
NPP

Feb 27, 2016

May 13, 2016

Feb 13, 2016

BORTEZOMIB - VELCADE

N 021602 001 5780454
5780454*PED
6713446
6713446*PED
6958319
6958319*PED

May
Nov
Jan
Jul
Jan
Jul

DS DP

D-141
D-142
I-695
M-139
M-165
ODE
PED
PED
PED

Oct
Oct
Oct
Aug
Sep
Oct
Feb
Apr
Apr

03,
03,
25,
25,
25,
25,

2017
2017
2022
2022
2022
2022

DP

DP

DS DP
DS DP

08,
08,
08,
08,
14,
08,
08,
08,
08,

2017

2017

2017

2017

2018

2021

2018

2018

2018

ADA 26 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

BORTEZOMIB - VELCADE
N 021602 001

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

PED
PED
PED

Apr 08, 2018

Mar 14, 2019
Apr 08, 2022

BOSENTAN - TRACLEER
N 021290 001 5292740

Nov 20, 2015

BOSENTAN - TRACLEER
N 021290 002 5292740

Nov 20, 2015

BOSUTINIB MONOHYDRATE - BOSULIF

N 203341 001 6002008
7417148
7767678
7919625
RE42376

Mar
Jan
Nov
Dec
Sep

27,
23,
23,
11,
24,

2018
2026
2026
2025
2019

DS DP U-1284
U-1283
DS DP
DP
DS

NCE
ODE

Sep 04, 2017

Sep 04, 2019

BOSUTINIB MONOHYDRATE - BOSULIF

N 203341 002 6002008
7417148
7767678
7919625
RE42376

Mar
Jan
Nov
Dec
Sep

27,
23,
23,
11,
24,

2018
2026
2026
2025
2019

DS DP U-1284
U-1283
DS DP
DP
DS

NCE
ODE

Sep 04, 2017

Sep 04, 2019

BREXPIPRAZOLE - REXULTI
N 205422 001 7888362
8349840
8618109

Feb 23, 2027

Apr 12, 2026
Apr 12, 2026

DS

NCE

Jul 10, 2020

BREXPIPRAZOLE - REXULTI
N 205422 002 7888362
8349840
8618109

Feb 23, 2027

Apr 12, 2026
Apr 12, 2026

DS

NCE

Jul 10, 2020

BREXPIPRAZOLE - REXULTI
N 205422 003 7888362
8349840
8618109

Feb 23, 2027

Apr 12, 2026
Apr 12, 2026

DS

NCE

Jul 10, 2020

BREXPIPRAZOLE - REXULTI
N 205422 004 7888362
8349840
8618109

Feb 23, 2027

Apr 12, 2026
Apr 12, 2026

DS

NCE

Jul 10, 2020

BREXPIPRAZOLE - REXULTI
N 205422 005 7888362
8349840
8618109

Feb 23, 2027

Apr 12, 2026
Apr 12, 2026

DS

NCE

Jul 10, 2020

BREXPIPRAZOLE - REXULTI
N 205422 006 7888362
8349840
8618109

Feb 23, 2027

Apr 12, 2026
Apr 12, 2026

DS

NCE

Jul 10, 2020

BRIMONIDINE TARTRATE - ALPHAGAN P

N 021262 001 6562873
Jul
6627210
Jul
6641834
Jul
6673337
Jul
BRIMONIDINE TARTRATE - QOLIANA
N 021764 001 7265117

DP U-1529
U-543

DP U-1529
U-543

DP U-1529
U-543

DP U-1529
U-543

DP U-1529
U-543

2021
2021
2021
2021

DP
DP
DP

Aug 19, 2025

DP

BRIMONIDINE TARTRATE - ALPHAGAN P

N 021770 001 6562873
Jul
6627210
Jul
6641834
Jul
6673337
Jul
8858961
Sep
8858961*PED
Mar

10,
18,
28,
26,

DP U-1529
U-543

10,
18,
28,
26,
02,
02,

2021
2021
2021
2021
2023
2024

DP
DP
DP
DP
DP

ADA 27 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

BRIMONIDINE TARTRATE - ALPHAGAN P

N 021770 001 6562873
Jul
6627210
Jul
6641834
Jul
6673337
Jul
8858961
Sep
8858961*PED
Mar

10,
18,
28,
26,
02,
02,

2021
2021
2021
2021
2023
2024

DP
DP
DP
DP
DP

BRIMONIDINE TARTRATE - MIRVASO

N 204708 001 7439241
8053427
8163725
8231885
8410102
8426410
8513247
8513249
8859551

25,
13,
13,
24,
24,
24,
25,
25,
25,

2025
2031
2031
2025
2025
2025
2031
2031
2024

U-1428
DP U-1428
DP
DP
U-1428
U-1428
DP U-1428
DP U-1428
U-1428

Aug
Jun
Jun
May
May
May
Mar
Mar
May

BRIMONIDINE TARTRATE; BRINZOLAMIDE - SIMBRINZA

N 204251 001 6316441
Dec 07, 2019
9044484
Oct 30, 2030

U-778

Sep
Jan
Jan
Jan
Jan
Jan
Jan
Jan

11,
16,
16,
16,
16,
16,
16,
16,

2025
2024
2024
2024
2024
2024
2024
2024

BROMOCRIPTINE MESYLATE - CYCLOSET

N 020866 001 7888310
Jul
8137992
Jul
8137993
Jul
8137994
Jul
8431155
Apr
8613947
Apr
8877708
Jun

25,
25,
25,
25,
30,
30,
07,

2023
2023
2023
2023
2032
2032
2030

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NDF

Aug 23, 2016

NC

Apr 19, 2016

NP

Apr 05, 2016

PC

Jan 23, 2016

DP

BRIMONIDINE TARTRATE; TIMOLOL MALEATE - COMBIGAN

N 021398 001 7030149
Apr 19, 2022
U-849
7320976
Apr 19, 2022
U-849
7323463
Jan 19, 2023
DP
7642258
Apr 19, 2022
DS DP U-1024
8133890
Apr 19, 2022
U-1235
8354409
Apr 19, 2022
DP U-1371
8748425
Apr 19, 2022
DP U-1524
BROMFENAC SODIUM - PROLENSA
N 203168 001 8129431
8669290
8754131
8871813
8927606
8927606
8927606
9144609

PATENT
DELIST
REQUESTED

DS DP
DP
DP
DP

U-100
U-810
U-1095
DP

U-1433
U-1433
U-1433
U-1433
DP U-976
DP U-976
DP U-1706

BUDESONIDE - BUDESONIDE
A 201966 001
BUDESONIDE - PULMICORT RESPULES
N 020929 001 6598603
6899099
7524834

Dec 23, 2018

Dec 23, 2018
Nov 11, 2018

U-529
U-529
DP U-966

BUDESONIDE - PULMICORT RESPULES

N 020929 002 6598603
6899099
7524834

Dec 23, 2018

Dec 23, 2018
Nov 11, 2018

U-529
U-529
DP U-966

BUDESONIDE - PULMICORT RESPULES

N 020929 003 6598603
6899099
7524834

Dec 23, 2018

Dec 23, 2018
Nov 11, 2018

U-529
U-529
DP U-966

ADA 28 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE

PATENT
CODES

BUDESONIDE - PULMICORT FLEXHALER

N 021949 001 6027714
6142145
6287540
7143764

Jan
May
Jan
Mar

09,
08,
09,
13,

2018
2018
2018
2018

DP U-787
DP
DP
DP

BUDESONIDE - PULMICORT FLEXHALER

N 021949 002 6027714
6142145
6287540
7143764

Jan
May
Jan
Mar

09,
08,
09,
13,

2018
2018
2018
2018

DP U-787
DP
DP
DP

BUDESONIDE - UCERIS
N 203634 001 7410651
7431943
8293273
8784888
8895064
9132093
9192581
RE43799

Jun
Jun
Jun
Jun
Sep
Sep
Sep
Jun

09,
09,
09,
09,
07,
07,
07,
09,

2020
2020
2020
2020
2031
2031
2031
2020

DP U-1325
DP
DP
DP
DP
DP
DP U-1325
DP U-1325

NDF

Jan 14, 2016

BUDESONIDE - UCERIS
N 205613 001 5914122

Dec 19, 2015

DP

NP

Oct 07, 2017

APPL/PROD
NO

PATENT NO

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT

N 021929 001 6123924
Sep 26, 2017
DP
7367333
Nov 11, 2018
DP
7587988
Apr 10, 2026
DP
7759328
Jan 29, 2023
DP U-1073
7967011
Aug 11, 2021
DP
8143239
Jan 29, 2023
DP U-1073
8387615
Nov 10, 2024
DP
8528545
Oct 16, 2028
DP
8575137
Jan 29, 2023
DP U-1073
8616196
Apr 07, 2029
DP
8875699
Nov 10, 2024
DP
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT
N 021929 002 6123924
Sep 26, 2017
DP
7367333
Nov 11, 2018
DP
7587988
Apr 10, 2026
DP
7759328
Jan 29, 2023
DP
7897646
Sep 09, 2018
7967011
Aug 11, 2021
DP
8143239
Jan 29, 2023
DP
8387615
Nov 10, 2024
DP
8461211
Sep 09, 2018
8528545
Oct 16, 2028
DP
8575137
Jan 29, 2023
DP
8616196
Apr 07, 2029
DP
8875699
Nov 10, 2024
DP

U-1073
U-1118
U-1073
U-1118
U-1073

BUPIVACAINE - EXPAREL
N 022496 001 8182835
8834921

Sep 18, 2018

Sep 18, 2018

DP U-1246
DP U-1587

BUPIVACAINE - EXPAREL
N 022496 002 8182835
8834921
9205052

Sep 18, 2018

Sep 18, 2018
Sep 18, 2018

DP U-1246
DP U-1587
U-1246

BUPRENORPHINE - BUTRANS
N 021306 001 6264980
6344211
6344211
RE41408
RE41408
RE41489
RE41489

Dec
Dec
Dec
Sep
Sep
Sep
Sep

DP

18,
18,
18,
29,
29,
29,
29,

2015
2015
2015
2017
2017
2017
2017

U-1072
U-1556
U-1072
U-1556
U-1072
U-1556

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 29 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

BUPRENORPHINE - BUTRANS
N 021306 001 RE41571
RE41571

Sep 29, 2017

Sep 29, 2017

BUPRENORPHINE - BUTRANS
N 021306 002 6264980
6344211
6344211
RE41408
RE41408
RE41489
RE41489
RE41571
RE41571

Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep

18,
18,
18,
29,
29,
29,
29,
29,
29,

2015
2015
2015
2017
2017
2017
2017
2017
2017

DP

BUPRENORPHINE - BUTRANS
N 021306 003 6264980
6344211
6344211
RE41408
RE41408
RE41489
RE41489
RE41571
RE41571

Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep

18,
18,
18,
29,
29,
29,
29,
29,
29,

2015
2015
2015
2017
2017
2017
2017
2017
2017

DP

BUPRENORPHINE - BUTRANS
N 021306 004 6264980
6344211
6344211
RE41408
RE41408
RE41489
RE41489
RE41571
RE41571

Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep

18,
18,
18,
29,
29,
29,
29,
29,
29,

2015
2015
2015
2017
2017
2017
2017
2017
2017

DP

BUPRENORPHINE - BUTRANS
N 021306 005 6264980
6344211
6344211
RE41408
RE41408
RE41489
RE41489
RE41571
RE41571

Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep

18,
18,
18,
29,
29,
29,
29,
29,
29,

2015
2015
2015
2017
2017
2017
2017
2017
2017

DP

BUPRENORPHINE HYDROCHLORIDE - BELBUCA

N 207932 001 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027
BUPRENORPHINE HYDROCHLORIDE - BELBUCA
N 207932 002 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027
BUPRENORPHINE HYDROCHLORIDE - BELBUCA
N 207932 003 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027
BUPRENORPHINE HYDROCHLORIDE - BELBUCA
N 207932 004 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1072
U-1556

U-1072
U-1556
U-1072
U-1556
U-1072
U-1556
U-1072
U-1556

U-1072
U-1556
U-1072
U-1556
U-1072
U-1556
U-1072
U-1556

U-1072
U-1556
U-1072
U-1556
U-1072
U-1556
U-1072
U-1556

U-1072
U-1556
U-1072
U-1556
U-1072
U-1556
U-1072
U-1556

DP

NP

Oct 23, 2018

NP

Oct 23, 2018

NP

Oct 23, 2018

NP

Oct 23, 2018

U-1769
DP U-1769

DP
U-1769
DP U-1769

DP
U-1769
DP U-1769

DP
U-1769
DP U-1769

ADA 30 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
BUPRENORPHINE HYDROCHLORIDE - BELBUCA

N 207932 005 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027
PATENT NO

BUPRENORPHINE HYDROCHLORIDE - BELBUCA

N 207932 006 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027
BUPRENORPHINE HYDROCHLORIDE - BELBUCA

N 207932 007 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027

PATENT
CODES
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NP

Oct 23, 2018

NP

Oct 23, 2018

NP

Oct 23, 2018

I-713

Aug 10, 2018

I-713

Aug 10, 2018

I-713

Aug 10, 2018

I-713

Aug 10, 2018

I-713

Aug 10, 2018

NP

Jun 06, 2017

U-1769

DP U-1769

DP
U-1769

DP U-1769

DP
U-1769

DP U-1769

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 022410 001 8017150
Feb 13, 2023
8475832
Mar 26, 2030
8603514
Apr 03, 2024

- SUBOXONE

DP

DP U-1411

DP U-1464

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 022410 002 8017150
Feb 13, 2023
8475832
Mar 26, 2030
8603514
Apr 03, 2024

- SUBOXONE

DP

DP U-1411

DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 022410 003 8017150
Feb 13, 2023
8475832
Mar 26, 2030
8603514
Apr 03, 2024

- SUBOXONE

DP

DP U-1411

DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 022410 004 8017150
Feb 13, 2023
8475832
Mar 26, 2030
8603514
Apr 03, 2024

- SUBOXONE

DP

DP U-1411

DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 204242 001 8454996
Sep 24, 2019
8470361
May 22, 2030
8658198
Dec 03, 2027
8940330
Sep 18, 2032

- ZUBSOLV

U-1421
DP U-1425

DP U-1494

DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 204242 002 8454996
Sep 24, 2019
8470361
May 22, 2030
8658198
Dec 03, 2027
8940330
Sep 18, 2032

- ZUBSOLV

U-1421
DP U-1425

DP U-1494

DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 204242 003 8454996
Sep 24, 2019
8470361
May 22, 2030
8658198
Dec 03, 2027
8940330
Sep 18, 2032

- ZUBSOLV

U-1421
DP U-1425

DP U-1494

DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 204242 004 8454996
Sep 24, 2019
8470361
May 22, 2030
8658198
Dec 03, 2027
8940330
Sep 18, 2032

- ZUBSOLV

U-1421
DP U-1425

DP U-1494

DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 204242 005 8454996
Sep 24, 2019
8470361
May 22, 2030
8658198
Dec 03, 2027
8940330
Sep 18, 2032

- ZUBSOLV

U-1421
DP U-1425

DP U-1494

DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 205637 001 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027
8703177
Aug 20, 2032

- BUNAVAIL

DP
U-1521

DP U-1521

DP

ADA 31 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
N 205637 002 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027
8703177
Aug 20, 2032

PATENT
CODES
- BUNAVAIL
DP
U-1521
DP U-1521
DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

N 205637 003 6159498
Oct 18, 2016
7579019
Jan 22, 2020
8147866
Jul 23, 2027
8703177
Aug 20, 2032

- BUNAVAIL
DP
U-1521
DP U-1521
DP

APPL/PROD
NO

PATENT NO

BUPROPION HYDROBROMIDE - APLENZIN

N 022108 001 7241805
Jun
7569610
Jun
7572935
Jun
7585897
Jun
7645802
Jun
7649019
Jun
7662407
Jun
7671094
Jun

27,
27,
27,
27,
27,
27,
27,
27,

2026
2026
2026
2026
2026
2026
2026
2026

DP

BUPROPION HYDROBROMIDE - APLENZIN

N 022108 002 7241805
Jun
7569610
Jun
7572935
Jun
7585897
Jun
7645802
Jun
7649019
Jun
7662407
Jun
7671094
Jun

27,
27,
27,
27,
27,
27,
27,
27,

2026
2026
2026
2026
2026
2026
2026
2026

DP

BUPROPION HYDROBROMIDE - APLENZIN

N 022108 003 7241805
Jun
7569610
Jun
7572935
Jun
7585897
Jun
7645802
Jun
7649019
Jun
7662407
Jun
7671094
Jun

27,
27,
27,
27,
27,
27,
27,
27,

2026
2026
2026
2026
2026
2026
2026
2026

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NP

Jun 06, 2017

NP

Jun 06, 2017

NC

Sep 10, 2017

U-997
DP
DP
DP
DP
DP
DP

U-997
DP
DP
DP
DP
DP
DP

U-997
DP
DP
DP
DP
DP
DP

BUPROPION HYDROCHLORIDE - WELLBUTRIN XL

N 021515 001 6096341
Oct 30, 2018
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N 021515 002 6096341
Oct 30, 2018
BUPROPION HYDROCHLORIDE - FORFIVO XL
N 022497 001 7674479
Jun 25, 2027

DP

BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE - CONTRAVE

N 200063 001 7375111
Mar 26, 2025
DP
7462626
Jul 20, 2024
U-1583
8088786
Feb 03, 2029
DP
8318788
Nov 08, 2027
U-1584
8722085
Nov 08, 2027
U-1585
8815889
Jul 20, 2024
U-1586
8916195
Feb 02, 2030
U-1639
9107837
Jun 04, 2027
U-1639
9125868
Nov 08, 2027
U-1585
BUTOCONAZOLE NITRATE - BUTOCONAZOLE NITRATE
N 019881 001 5993856
Nov 17, 2017
CABAZITAXEL - JEVTANA KIT
N 201023 001 5847170
6331635
6372780
6387946

Mar
Mar
Mar
Mar

26,
26,
26,
26,

2021
2016
2016
2016

DP U-457

DS DP
DS DP
U-1067
U-1067

ADA 32 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

CABAZITAXEL - JEVTANA KIT

N 201023 001 7241907
8927592

PATENT
EXPIRATION
DATE
Dec 10, 2025
Oct 27, 2030

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DS

U-1630

CABOZANTINIB S-MALATE - COMETRIQ

N 203756 001 7579473
Sep 24, 2024
8877776
Oct 08, 2030

DS DP
DS DP U-1617

NCE
ODE

Nov 29, 2017

Nov 29, 2019

CABOZANTINIB S-MALATE - COMETRIQ

N 203756 002 7579473
Sep 24, 2024
8877776
Oct 08, 2030

DS DP
DS DP U-1617

NCE
ODE

Nov 29, 2017

Nov 29, 2019

I-657

Sep 27, 2015

CALCIPOTRIENE - SORILUX

N 022563 001 8263580
8629128
8629128

Sep 27, 2028

May 26, 2026
May 26, 2026

CALCITONIN SALMON RECOMBINANT - FORTICAL

N 021406 001 6440392
Feb 02, 2021
RE40812
Feb 02, 2021
RE43580
Feb 02, 2021
CALCITRIOL - CALCIJEX

N 018874 001 6051567
6265392
6274169

Aug 02, 2019

Aug 02, 2019

Aug 02, 2019

CALCITRIOL - CALCIJEX

N 018874 002 6051567
6265392
6274169

Aug 02, 2019

Aug 02, 2019

Aug 02, 2019

CALCIUM ACETATE - PHOSLO

N 021160 002 6576665

Apr 03, 2021

DP U-1280
DP U-1280

DP U-1767

DP U-227

DP

DP U-227

CALCIUM ACETATE - PHOSLO GELCAPS

N 021160 003 6576665
Apr 03, 2021

6875445
Jul 30, 2021

DP

CALCIUM ACETATE - PHOSLYRA

N 022581 001 8591938
8592480
9089528

DP U-1469

U-1469

U-1469

Feb 23, 2030

Jul 20, 2027
Jul 20, 2027

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE - PEPCID COMPLETE

N 020958 001 5989588
Sep 30, 2017
DP U-349

5989588*PED
Mar 30, 2018

6814978
Aug 26, 2021
DP

CALCIUM CARBONATE; RISEDRONATE SODIUM - ACTONEL WITH CALCIUM (COPACKAGED)

N 021823 001 5994329

Jul 17, 2018
U-353

6015801
Jul 17, 2018
U-353

6165513
Jun 10, 2018
DP

6432932
Jul 17, 2018
U-595

6465443
Aug 14, 2018
DP

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;

SODIUM CHLORIDE; SODIUM PHOSPHATE - NAVSTEL

N 022193 001 7084130
Nov 29, 2021
DP U-891

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM

PHOSPHATE - PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER

N 207026 001
ODE
Jan 13, 2022

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM

PHOSPHATE - PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER

N 207026 002
ODE
Jan 13, 2022

CANAGLIFLOZIN - INVOKANA

N 204042 001 7943582
7943788

Feb 26, 2029

Jul 14, 2027

DS DP U-493
DS DP

NCE

Mar 29, 2018

ADA 33 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CANAGLIFLOZIN - INVOKANA

N 204042 001 8222219
8513202

Jul 30, 2024

Dec 03, 2027

U-493

DS DP U-493

CANAGLIFLOZIN - INVOKANA

N 204042 002 7943582
7943788
8222219
8513202

Feb
Jul
Jul
Dec

DS DP U-493
DS DP

U-493

DS DP U-493

26,
14,
30,
03,

2029
2027
2024
2027

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NCE

Mar 29, 2018

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE N 204353 001 7943582

Feb 26,
7943788
Jul 14,
8222219
Jul 30,
8513202
Dec 03,
8785403
Jul 30,

INVOKAMET

2029
DS
2027
DS
2024
2027
DS
2024

DP U-493
DP
U-493

DP U-493

DP

NC
NCE

Aug 08, 2017

Mar 29, 2018

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE N 204353 002 7943582

Feb 26,
7943788
Jul 14,
8222219
Jul 30,
8513202
Dec 03,
8785403
Jul 30,

INVOKAMET

2029
DS
2027
DS
2024
2027
DS
2024

DP U-493
DP
U-493

DP U-493

DP

NC
NCE

Aug 08, 2017

Mar 29, 2018

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE N 204353 003 7943582

Feb 26,
7943788
Jul 14,
8222219
Jul 30,
8513202
Dec 03,
8785403
Jul 30,

INVOKAMET

2029
DS
2027
DS
2024
2027
DS
2024

DP U-493
DP
U-493

DP U-493

DP

NC
NCE

Aug 08, 2017

Mar 29, 2018

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE N 204353 004 7943582

Feb 26,
7943788
Jul 14,
8222219
Jul 30,
8513202
Dec 03,
8785403
Jul 30,

INVOKAMET

2029
DS
2027
DS
2024
2027
DS
2024

DP U-493
DP
U-493

DP U-493

DP

NC
NCE

Aug 08, 2017

Mar 29, 2018

CANGRELOR - KENGREAL

N 204958 001 6114313
6130208
8680052
8759316

2017
2018
2033
2029

DP U-1715
DP U-1715

U-1715

U-1715

NCE

Jun 22, 2020

M-131
PED

Dec 10, 2016

Jun 10, 2017

M-131
PED

Dec 10, 2016

Jun 10, 2017

ODE

Nov 16, 2016

Dec
Jun
Mar
May

11,
29,
09,
13,

CAPECITABINE - XELODA

N 020896 001

CAPECITABINE - XELODA

N 020896 002

CAPSAICIN - QUTENZA

N 022395 001 6239180

Nov 06, 2016

CARBAMAZEPINE - CARBATROL

N 020712 001 5912013

Jun 15, 2016

U-277

CARBAMAZEPINE - CARBATROL

N 020712 002 5912013

Jun 15, 2016

U-277

CARBAMAZEPINE - CARBATROL

N 020712 003 5912013

Jun 15, 2016

U-277

CARBAMAZEPINE - EQUETRO

N 021710 001 5912013
6977253

Jun 15, 2016

May 19, 2024

DP

DP

U-693

ADA 34 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CARBAMAZEPINE - EQUETRO
N 021710 002 5912013
6977253

Jun 15, 2016

May 19, 2024

DP

CARBAMAZEPINE - EQUETRO
N 021710 003 5912013
6977253

Jun 15, 2016

May 19, 2024

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-693

U-693

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 50

N 021485 001 6500867
Jun 29, 2020
6797732
Jun 29, 2020

DP U-219
DP

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 100

N 021485 002 6500867
Jun 29, 2020
6797732
Jun 29, 2020

DP U-219
DP

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 150

N 021485 003 6500867
Jun 29, 2020
6797732
Jun 29, 2020

DP U-219
DP

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 200

N 021485 004 6500867
Jun 29, 2020
6797732
Jun 29, 2020

DP U-219
DP

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 75

N 021485 005 6500867
Jun 29, 2020
6797732
Jun 29, 2020

DP U-219
DP

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 125

N 021485 006 6500867
Jun 29, 2020
6797732
Jun 29, 2020

DP U-219
DP

CARBIDOPA; LEVODOPA - RYTARY

N 203312 001 7094427
8377474
8377474
8454998
8454998
8454998
8454998
8454998
8557283
8557283
9089607
9089607
9089608

May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,

2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-1645
U-219
U-1645
U-219
U-1645
U-1646
U-1647
U-1649
U-219
U-1645
U-1645
U-1720

NDF

Jan 07, 2018

CARBIDOPA; LEVODOPA - RYTARY

N 203312 002 7094427
8377474
8377474
8454998
8454998
8454998
8454998
8454998
8557283
8557283
9089607
9089607
9089608

May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,

2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-1645
U-219
U-1645
U-219
U-1645
U-1646
U-1647
U-1649
U-219
U-1645
U-1645
U-1720

NDF

Jan 07, 2018

CARBIDOPA; LEVODOPA - RYTARY

N 203312 003 7094427
8377474
8377474
8454998
8454998
8454998
8454998

May
Dec
Dec
Dec
Dec
Dec
Dec

29,
26,
26,
26,
26,
26,
26,

2022
2028
2028
2028
2028
2028
2028

DP
DP
DP
DP
DP
DP
DP

U-1645
U-219
U-1645
U-219
U-1645
U-1646
U-1647

NDF

Jan 07, 2018

ADA 35 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CARBIDOPA; LEVODOPA - RYTARY

N 203312 003 8454998
8557283
8557283
9089607
9089607
9089608

Dec
Dec
Dec
Dec
Dec
Dec

26,
26,
26,
26,
26,
26,

2028
2028
2028
2028
2028
2028

DP
DP
DP
DP
DP
DP

U-1649
U-219
U-1645
U-1645
U-1720

CARBIDOPA; LEVODOPA - RYTARY

N 203312 004 7094427
8377474
8377474
8454998
8454998
8454998
8454998
8454998
8557283
8557283
9089607
9089607
9089608

May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,

2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-1645
U-219
U-1645
U-219
U-1645
U-1646
U-1647
U-1649
U-219
U-1645
U-1645
U-1720

PATENT NO

PATENT
DELIST
REQUESTED

CARBIDOPA; LEVODOPA - DUOPA

N 203952 001

CARBINOXAMINE MALEATE - KARBINAL ER

N 022556 001 8062667
Mar 29, 2029
CARFILZOMIB - KYPROLIS
N 202714 001 7232818
7417042
7491704
7737112
8129346
8207125
8207126
8207127
8207297

Apr
Jun
Apr
Dec
Dec
Apr
Apr
Apr
Apr

14,
07,
14,
07,
25,
14,
14,
14,
14,

2025
2026
2025
2027
2026
2025
2025
2025
2025

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NDF

Jan 07, 2018

NP
ODE

Jan 09, 2018

Jan 09, 2022

I-712
NCE
ODE

Jul 24, 2018

Jul 20, 2017
Jul 20, 2019

ODE

Mar 18, 2017

DP

DS DP
DS DP
U-1260
DP
U-1260
DS DP
DP
U-1260
DS DP

CARGLUMIC ACID - CARBAGLU

N 022562 001
CARIPRAZINE HYDROCHLORIDE - VRAYLAR
N 204370 001 7737142
Mar 27, 2027
7943621
Dec 16, 2028

DS DP U-1750
DS DP

NCE

Sep 17, 2020

CARIPRAZINE HYDROCHLORIDE - VRAYLAR

N 204370 002 7737142
Mar 27, 2027
7943621
Dec 16, 2028

DS DP U-1750
DS DP

NCE

Sep 17, 2020

CARIPRAZINE HYDROCHLORIDE - VRAYLAR

N 204370 003 7737142
Mar 27, 2027
7943621
Dec 16, 2028

DS DP U-1750
DS DP

NCE

Sep 17, 2020

CARIPRAZINE HYDROCHLORIDE - VRAYLAR

N 204370 004 7737142
Mar 27, 2027
7943621
Dec 16, 2028

DS DP U-1750
DS DP

NCE

Sep 17, 2020

CARVEDILOL PHOSPHATE - COREG CR

N 022012 001 6022562
7268156
7268156
8101209

Oct
Jun
Jun
Sep

2015
2023
2023
2025

DP
DS DP U-3
DS DP U-313
DP

CARVEDILOL PHOSPHATE - COREG CR

N 022012 002 6022562
7268156
7268156

Oct 17, 2015

Jun 27, 2023
Jun 27, 2023

DP
DS DP U-3
DS DP U-313

17,
27,
27,
11,

ADA 36 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CARVEDILOL PHOSPHATE - COREG CR

N 022012 002 8101209

Sep 11, 2025

DP

CARVEDILOL PHOSPHATE - COREG CR

N 022012 003 6022562
7268156
7268156
8101209

Oct
Jun
Jun
Sep

17,
27,
27,
11,

2015
2023
2023
2025

DP
DS DP U-3
DS DP U-313
DP

CARVEDILOL PHOSPHATE - COREG CR

N 022012 004 6022562
7268156
7268156
8101209

Oct
Jun
Jun
Sep

17,
27,
27,
11,

2015
2023
2023
2025

DP
DS DP U-3
DS DP U-313
DP

CASPOFUNGIN ACETATE - CANCIDAS

N 021227 001 5952300
6136783

Mar 28, 2017

Mar 28, 2017

DP

CASPOFUNGIN ACETATE - CANCIDAS

N 021227 002 5952300
6136783

Mar 28, 2017

Mar 28, 2017

DP

CEFDITOREN PIVOXIL - SPECTRACEF

N 021222 001 5958915

Oct 14, 2016

CEFDITOREN PIVOXIL - SPECTRACEF

N 021222 002 5958915

Oct 14, 2016

CEFTAROLINE FOSAMIL - TEFLARO

N 200327 001 6417175
6906055
7419973
8247400

Apr
Dec
Dec
Feb

11,
15,
15,
10,

2022
2021
2021
2031

DS DP U-1676
DS DP
DP
DP U-282

NCE

Oct 29, 2015

CEFTAROLINE FOSAMIL - TEFLARO

N 200327 002 6417175
6906055
7419973
8247400

Apr
Dec
Dec
Feb

11,
15,
15,
10,

2022
2021
2021
2031

DS DP U-1676
DS DP
DP
DP U-282

NCE

Oct 29, 2015

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM N 206829 001 7129232

Oct 21,
8476425
Sep 27,
8685957
Sep 27,
8906898
May 28,
8968753
Mar 14,
8968753
Mar 14,

ZERBAXA
2024
2032
2032
2034
2034
2034

DS DP U-36
DS
DS
U-36
DS DP
U-1672
U-1673

NCE
GAIN

Dec 19, 2019

Dec 19, 2024

CERITINIB - ZYKADIA
N 205755 001 7153964
7893074
7964592
8039474
8039479
8377921
8703787

2021
2026
2027
2030
2030
2027
2032

DS
DS
DS
DS
DS

NCE
ODE

Apr 29, 2019

Apr 29, 2021

PATENT NO

Feb
Apr
Jan
Jun
Jun
Nov
Feb

26,
25,
13,
29,
29,
20,
02,

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-607

U-607

DP

DP
DP
DP
DP
DP
U-1179
U-1179

CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY

N 021621 003 6455533
Jul 02, 2018
DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY
N 021621 004 6455533
Jul 02, 2018
DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
N 021621 005 6455533
Jul 02, 2018
DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
N 021621 006 6455533
Jul 02, 2018
DP U-295

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 37 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
PATENT
EXPIRATION
DELIST
PATENT
DATE
REQUESTED
CODES
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ZYRTEC-D 12 HOUR

N 021150 002 6469009
Jul 13, 2019
DP U-295

6489329
Apr 08, 2016
DP

7014867
Jun 10, 2022
DP

7226614
Jun 10, 2022
U-295

PATENT NO

CETRORELIX - CETROTIDE

N 021197 001 6319192

Apr 23, 2019

U-426

CETRORELIX - CETROTIDE

N 021197 002 6319192

Apr 23, 2019

U-426

CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE

N 021669 001 7066916
Feb 17, 2024
7427574
Apr 25, 2026
7595021
May 12, 2023
7717889
Feb 27, 2025
7935093
Oct 02, 2027

EXCLUSIVITY
CODE(S)

U-737

DP

DP U-1022

DP U-1022

DP U-1022

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP

N 020832 001 5690958
Sep 30, 2016
DP

6536975
Nov 10, 2020
DP

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT

N 020832 002 5690958
Sep 30, 2016
DP

6729786
Mar 14, 2023
DP

6991394
Jan 31, 2024
DP

7182536
Dec 30, 2023
DP

7241065
Mar 14, 2023
DP

7422388
Apr 25, 2027
DP U-1397

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP FREPP

N 020832 003 5538353
Aug 25, 2015
DP

5690958
Sep 30, 2016
DP

5772346
Apr 22, 2017
DP

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP

N 020832 004 5690958
Sep 30, 2016
DP

6536975
Nov 10, 2020
DP

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT

N 020832 005 5690958
Sep 30, 2016
DP

6536975
Nov 10, 2020
DP

6729786
Mar 14, 2023
DP

7241065
Mar 14, 2023
DP

7422388
Apr 25, 2027
DP U-1397

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP

N 020832 006 5690958
Sep 30, 2016
DP

6991394
Jan 31, 2024
DP

7182536
Dec 30, 2023
DP

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT

N 020832 007 5690958
Sep 30, 2016
DP

6536975
Nov 10, 2020
DP

6729786
Mar 14, 2023
DP

7241065
Mar 14, 2023
DP

7422388
Apr 25, 2027
DP U-1397

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - PREVANTICS MAXI SWABSTICK

N 021524 003 D468424
Jan 07, 2017

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP SEPP

N 021555 001 5690958
Sep 30, 2016
DP

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE - CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE

N 206323 001 6248363
Nov 23, 2019
DP U-1716

6383471
Apr 06, 2019
DP U-1716

9066942
Jan 03, 2032
U-1716

9107921
Jan 03, 2032
DP

EXCLUSIVITY

EXPIRATION

DATE

ADA 38 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
PATENT
EXPIRATION
DELIST
PATENT
EXCLUSIVITY
DATE
REQUESTED
CODES
CODE(S)
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - ADVIL ALLERGY SINUS

N 021441 001 7863287
Feb 28, 2027
DP

PATENT NO

EXCLUSIVITY

EXPIRATION

DATE

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX - TUZISTRA XR

N 207768 001 8062667
Mar 29, 2029
DP

8790700
Mar 15, 2027
DP

CHOLIC ACID - CHOLBAM

N 205750 001

ODE

Mar 17, 2022

CHOLIC ACID - CHOLBAM

N 205750 002

ODE

Mar 17, 2022

NCE
W

Sep 12, 2017

Sep 12, 2017

CHOLINE C-11 - CHOLINE C-11

N 203155 001

CHOLINE FENOFIBRATE - TRILIPIX

N 022224 001 7259186

Jan 07, 2025

DS

CHOLINE FENOFIBRATE - TRILIPIX

N 022224 002 7259186

Jan 07, 2025

DS

CHORIOGONADOTROPIN ALFA - OVIDREL

N 021149 002 6706681
Mar 16, 2021

DP

CICLESONIDE - ALVESCO

N 021658 002 5482934
5775321
6006745
6120752
6264923
8371292

Oct
Jul
Dec
May
May
Feb

24,
07,
28,
13,
13,
01,

2017
2015
2016
2018
2018
2028

DS DP U-1002
DP

DP

DP

DP

U-1355

M-125

Dec 17, 2015

CICLESONIDE - ALVESCO

N 021658 003 5482934
5775321
6006745
6120752
6264923
8371292

Oct
Jul
Dec
May
May
Feb

24,
07,
28,
13,
13,
01,

2017
2015
2016
2018
2018
2028

DS DP U-1002
DP

DP

DP

DP

U-1355

M-125

Dec 17, 2015

CICLESONIDE - OMNARIS

N 022004 001 5482934
6767901
6939559
7235247
8371292
8383611

Oct
Oct
Apr
Apr
Feb
Oct

24,
21,
21,
21,
01,
20,

2017
2020
2019
2019
2028
2020

DS DP U-557

DP

DP

DP

U-1356

DP

CICLESONIDE - ZETONNA

N 202129 001 5482934
5775321
6006745
6120752
6264923
8371292

Oct
Jul
Dec
May
May
Feb

24,
07,
28,
13,
13,
01,

2017
2015
2016
2018
2018
2028

DS DP U-1002

DP

DP

DP

DP

U-1357

CICLOPIROX - LOPROX

N 020519 001 7018656
7026337

Sep 05, 2018

Nov 21, 2016

CICLOPIROX - LOPROX

N 021159 001 7981909
8227490

Sep 16, 2017

Sep 16, 2017

ODE
ODE

Feb 25, 2018

Nov 21, 2021

CINACALCET HYDROCHLORIDE - SENSIPAR

N 021688 001 6011068
Mar
6031003
Dec
6211244
Oct
6313146
Dec

08,
14,
23,
14,

2018
2016
2015
2016

DP

U-714

U-1162

U-1256

DS DP
U-559
DS DP U-560
DS DP

ADA 39 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
CINACALCET HYDROCHLORIDE - SENSIPAR
N 021688 001 7829595
Sep 22, 2026
APPL/PROD
NO

PATENT NO

PATENT
CODES

08,
14,
23,
14,
22,

2018
2016
2015
2016
2026

DS DP

CINACALCET HYDROCHLORIDE - SENSIPAR

N 021688 003 6011068
Mar
6031003
Dec
6211244
Oct
6313146
Dec
7829595
Sep

08,
14,
23,
14,
22,

2018
2016
2015
2016
2026

DS DP

Apr 27, 2030

Apr 21, 2029
Jul 01, 2035

CIPROFLOXACIN HYDROCHLORIDE - PROQUIN XR

N 021744 001 5972389
Sep 19,
6340475
Sep 19,
6488962
Jun 20,
6635280
Sep 19,

2016
2016
2020
2016

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-1098

CINACALCET HYDROCHLORIDE - SENSIPAR

N 021688 002 6011068
Mar
6031003
Dec
6211244
Oct
6313146
Dec
7829595
Sep

CIPROFLOXACIN - OTIPRIO
N 207986 001 8318817
9205048
9220796

PATENT
DELIST
REQUESTED

ODE
ODE

Feb 25, 2018

Nov 21, 2021

ODE
ODE

Feb 25, 2018

Nov 21, 2021

NP

Jul 16, 2015

DS DP U-560
DS DP
DP U-1098

U-559
DS DP U-560
DS DP
DP U-1098

U-1792
U-1793
DP

DP U-663
DP U-663
DP
DP U-663

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR

N 021473 001 7709022
Jun 23, 2021
DP
8187632
Jun 23, 2021
DP
8187632*PED
Dec 23, 2021
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR
N 021473 002 7709022
Jun 23, 2021
DP
8187632
Jun 23, 2021
DP
8187632*PED
Dec 23, 2021
CIPROFLOXACIN; DEXAMETHASONE - CIPRODEX
N 021537 001 6284804
Aug 10,
6359016
Aug 10,
8846650
Jun 04,
9149486
Sep 13,

2020
2020
2025
2022

DP U-1578
DP U-1578

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE - PREPOPIK

N 202535 001 8450338
Oct 10, 2028
DP
8481083
Oct 10, 2028
DP
CLARITHROMYCIN - BIAXIN XL
N 050775 001 6010718
6551616

Apr 11, 2017

Jun 15, 2017

DP U-924
U-924

CLEVIDIPINE - CLEVIPREX
N 022156 001 5856346
8658676

Jan 05, 2021

Oct 10, 2031

DS DP U-893
DP

CLEVIDIPINE - CLEVIPREX
N 022156 002 5856346
8658676

Jan 05, 2021

Oct 10, 2031

DS DP U-893
DP

CLEVIDIPINE - CLEVIPREX
N 022156 003 5856346
8658676

Jan 05, 2021

Oct 10, 2031

DS DP U-893
DP

CLINDAMYCIN PHOSPHATE - CLEOCIN

N 050767 001 6495157

Jul 20, 2020

CLINDAMYCIN PHOSPHATE - CLINDAGEL

N 050782 001 6387383
Aug 03, 2020

DP

DP U-818

ADA 40 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

CLINDAMYCIN PHOSPHATE - CLINDESSE

N 050793 001 5993856
Nov 17, 2017
6899890
Apr 27, 2023
CLINDAMYCIN PHOSPHATE - EVOCLIN
N 050801 001 7141237
7374747

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-137
DP U-137

Jan 23, 2024

Aug 09, 2026

DS DP
DS DP U-921

CLINDAMYCIN PHOSPHATE; TRETINOIN - ZIANA

N 050802 001 6387383
Aug 03, 2020

DP U-916

CLOBAZAM - ONFI
N 202067 001

NCE
ODE

Oct 21, 2016

Oct 21, 2018

NCE
ODE

Oct 21, 2016

Oct 21, 2018

NCE
ODE

Oct 21, 2016

Oct 21, 2018

NCE
ODE

Oct 21, 2016

Oct 21, 2018

PC

Jul 01, 2015

CLONIDINE HYDROCHLORIDE - KAPVAY

N 022331 003

M-149

Nov 20, 2017

CLONIDINE HYDROCHLORIDE - KAPVAY

N 022331 004

M-149

Nov 20, 2017

CLOBAZAM - ONFI
N 202067 002

CLOBAZAM - ONFI
N 202067 003

CLOBAZAM - ONFI
N 203993 001

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE

A 090898 001
CLOBETASOL PROPIONATE - OLUX
N 021142 001 6126920

Mar 01, 2016

CLOBETASOL PROPIONATE - CLOBEX

N 021535 001 6106848

Sep 22, 2017

CLOBETASOL PROPIONATE - CLOBEX

N 021644 001 7316810
7700081
8066975
8066976

Jun
Jan
Jun
Jun

CLOBETASOL PROPIONATE - CLOBEX

N 021835 001 5972920
5990100

Feb 12, 2018

Mar 24, 2018

DP
DP U-742

CLOBETASOL PROPIONATE - OLUX E

N 022013 001 6730288
7029659
8460641
8962000

Sep
Sep
Nov
Aug

DP
DP
DP U-1410
DP U-1410

CLOFARABINE - CLOLAR
N 021673 001 5661136

Jan 14, 2018

17,
03,
17,
17,

08,
08,
05,
31,

2019
2022
2019
2019

2019
2019
2028
2025

U-484

DP
U-1044
DP
DP

U-626

CLOPIDOGREL BISULFATE - PLAVIX

N 020839 001 6429210
6504030

Jun 10, 2019

Jun 10, 2019

DS DP
DS

CLOPIDOGREL BISULFATE - PLAVIX

N 020839 002 6429210
6504030

Jun 10, 2019

Jun 10, 2019

DS DP
DS

ADA 41 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CLOZAPINE - FAZACLO ODT

N 021590 001 6024981
6106861
6221392

Apr 09, 2018

Dec 05, 2017
Apr 09, 2018

DP

DP

DP

CLOZAPINE - FAZACLO ODT

N 021590 002 6024981
6106861
6221392

Apr 09, 2018

Dec 05, 2017
Apr 09, 2018

DP

DP

DP

CLOZAPINE - FAZACLO ODT

N 021590 003 6024981
6106861
6221392

Apr 09, 2018

Dec 05, 2017
Apr 09, 2018

DP

DP

DP

CLOZAPINE - FAZACLO ODT

N 021590 004 6024981
6106861
6221392

Apr 09, 2018

Dec 05, 2017
Apr 09, 2018

DP

DP

DP

CLOZAPINE - FAZACLO ODT

N 021590 005 6024981
6106861
6221392

Apr 09, 2018

Dec 05, 2017
Apr 09, 2018

DP

DP

DP

CLOZAPINE - FAZACLO ODT

N 021590 006 6024981
6106861
6221392

Apr 09, 2018

Dec 05, 2017
Apr 09, 2018

DP

DP

DP

COBICISTAT - TYBOST

N 203094 001 8148374

Sep 03, 2029

COBICISTAT; DARUNAVIR ETHANOLATE

N 205395 001 5843946
5843946*PED
7470506
7470506*PED
7700645
7700645*PED
8148374
8518987
8518987*PED
8597876
8597876*PED
RE42889
RE42889*PED
RE43596
RE43596*PED
RE43802
RE43802*PED

- PREZCOBIX

Dec 01, 2015
Jun 01, 2016

Jun 23, 2019
Dec 23, 2019

Dec 26, 2026
Jun 26, 2027

Sep 03, 2029
Feb 16, 2024
Aug 16, 2024

Jun 23, 2019

Dec 23, 2019

Oct 19, 2016
Apr 19, 2017

May 09, 2017

Nov 09, 2017

Oct 19, 2016
Apr 19, 2017

PATENT NO

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE;

N 207561 001 5814639
Sep 29,
5814639*PED
Mar 29,
5914331
Jul 02,
5914331*PED
Jan 02,
6642245
Nov 04,
6642245*PED
May 04,
6703396
Mar 09,
7176220
Nov 20,
7390791
May 07,
7635704
Oct 26,
7800788
Feb 02,
8148374
Sep 03,
8633219
Apr 24,
8754065
Aug 15,
8981103
Oct 26,

DS DP U-1279

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

NP

EXCLUSIVITY

EXPIRATION

DATE

Sep 24, 2017

DP U-1660

U-1660

DS DP

DS DP U-1660

DS DP

U-1660

DP

DS DP

U-1660

TENOFOVIR ALAFENAMIDE FUMARATE - GENVOYA

2015
DS DP
NCE
2017

2017
DS

2018

2020
U-257

2021

2021
DS DP

2023
DS DP U-257

2022
DS DP

2026
DS DP U-257

2022
U-257

2029
DS DP U-1279

2030
DP U-257

2032
DS DP U-257

2026
DS DP

Nov 05, 2020

ADA 42 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
PATENT
EXPIRATION
DELIST
PATENT
EXCLUSIVITY
DATE
REQUESTED
CODES
CODE(S)
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - STRIBILD

N 203100 001 5814639
Sep 29, 2015
DS DP

I-704
5914331
Jul 02, 2017
DS

NP
5922695
Jul 25, 2017
DS
U-257

5935946
Jul 25, 2017
DS DP U-257

5977089
Jul 25, 2017
DS DP U-257

6043230
Jul 25, 2017
U-257

6642245
Nov 04, 2020
U-257

6703396
Mar 09, 2021
DS DP

7176220
Nov 20, 2023
DS DP U-257

7635704
Oct 26, 2026
DS DP U-257

8148374
Sep 03, 2029
DS DP U-1279

8592397
Jan 13, 2024
DP U-257

8633219
Apr 24, 2030
DP U-257

8716264
Jan 13, 2024
DP U-257

8981103
Oct 26, 2026
DS DP

PATENT NO

COBIMETINIB FUMARATE - COTELLIC

N 206192 001 7803839
Feb 01, 2027
8362002
Oct 05, 2026

DS DP

Dec 17, 2017

Aug 27, 2015

NCE

Nov 10, 2020

ODE

Jul 29, 2016

ODE

Oct 15, 2017

M-163
NCE
ODE

Sep 14, 2018

Aug 26, 2016

Aug 26, 2018

U-1776

COLCHICINE - COLCRYS

N 022352 001 7601758
7619004
7820681
7906519
7915269
7935731
7964647
7964648
7981938
8093296
8093297
8093298
8097655
8415395
8415396
8440721
8440722

Feb
Dec
Feb
Feb
Feb
Dec
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Feb
Feb

2029
2028
2029
2029
2029
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2029
2029

U-1007

U-1020

U-1020

U-1116

U-1007

U-1116

U-1007

U-1161

U-1166

U-1007

U-1161

U-1116

U-1020

U-1007

U-1007

U-1007

U-1020

COLCHICINE - MITIGARE

N 204820 001 8927607

Aug 22, 2033

U-1020

10,
03,
17,
17,
17,
03,
06,
06,
06,
06,
06,
06,
06,
06,
06,
17,
17,

EXCLUSIVITY

EXPIRATION

DATE

COLESEVELAM HYDROCHLORIDE - WELCHOL

N 021176 001 7229613
Apr 17, 2022

U-851

COLESEVELAM HYDROCHLORIDE - WELCHOL

N 022362 001 7229613
Apr 17, 2022

U-493

COLESEVELAM HYDROCHLORIDE - WELCHOL

N 022362 002 7229613
Apr 17, 2022

U-493

CONIVAPTAN HYDROCHLORIDE - VAPRISOL

N 021697 001 5723606
Dec 15, 2019
5723606
Dec 15, 2019

DS DP U-698

DS DP U-868

CONIVAPTAN HYDROCHLORIDE - VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER

N 021697 002 5723606
Dec 15, 2019
DS DP U-698

5723606
Dec 15, 2019
DS DP U-868

CORTICOTROPIN - H.P. ACTHAR GEL

N 008372 008

CRIZOTINIB - XALKORI

N 202570 001 7230098
7825137
7858643
8217057
8785632

Aug
May
Oct
Nov
Mar

26,
12,
08,
06,
01,

2025
2027
2029
2029
2025

DS

U-1179

DS DP

DS DP

DS

ADA 43 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CRIZOTINIB - XALKORI
N 202570 002 7230098
7825137
7858643
8217057
8785632

Aug
May
Oct
Nov
Mar

26,
12,
08,
06,
01,

2025
2027
2029
2029
2025

CROFELEMER - FULYZAQ
N 202292 001 7323195
7341744
8574634
8962680

Jun
Jun
Jan
Oct

07,
16,
11,
31,

2018
2018
2018
2031

DP

CYANOCOBALAMIN - NASCOBAL
N 021642 001 7229636
7404489
7879349
8003353
8940714

Aug
Mar
Aug
Aug
Feb

01,
12,
01,
01,
26,

2024
2024
2024
2024
2024

DP U-817
DP
DP U-1152
U-817
U-1152

CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX

N 021777 001 7387793
Feb 26,
7544372
Nov 14,
7790199
Nov 14,
7820203
Nov 14,
7829121
Nov 14,

2025
2023
2023
2023
2023

DP

CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX

N 021777 002 7387793
Feb 26,
7544372
Nov 14,
7790199
Nov 14,
7820203
Nov 14,
7829121
Nov 14,

2025
2023
2023
2023
2023

DP

CYCLOSPORINE - RESTASIS
N 050790 001 8629111
8633162
8642556
8648048
8685930

2024
2024
2024
2024
2024

DP

Aug
Aug
Aug
Aug
Aug

27,
27,
27,
27,
27,

DS
U-1179
DS DP
DS DP
DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-163
NCE
ODE

Sep 14, 2018

Aug 26, 2016
Aug 26, 2018

NCE

Dec 31, 2017

NDF
NPP
ODE
ODE

Apr
Aug
Apr
Aug

30,
14,
30,
14,

2016
2018
2020
2022

NDF
NPP
ODE
ODE

Apr
Aug
Apr
Aug

30,
14,
30,
14,

2016
2018
2020
2022

NP
ODE

Oct 02, 2015

Oct 02, 2019

U-1319
U-1319
U-1319

U-979
DP
DP
U-1088

U-979
DP
DP
U-1088

U-1479
DP
U-1483
DP

CYSTEAMINE BITARTRATE - PROCYSBI

N 203389 001 8026284
Sep 22, 2027
9173851
Jun 17, 2034
9192590
Jan 26, 2027
9198882
Jan 26, 2027

DP

CYSTEAMINE BITARTRATE - PROCYSBI

N 203389 002 8026284
Sep 22, 2027
9173851
Jun 17, 2034
9192590
Jan 26, 2027
9198882
Jan 26, 2027

DP

U-1399
U-1399
U-1399

U-1399
U-1399
U-1399

CYSTEAMINE HYDROCHLORIDE - CYSTARAN

N 200740 001

DABIGATRAN ETEXILATE MESYLATE - PRADAXA

N 022512 001 6087380
Feb 18,
7866474
Aug 31,
7932273
Sep 07,
9034822
Jan 20,

2018
2027
2025
2031

DS DP U-1089
DP
DS DP
U-1759

I-682
I-683
M-168
NCE

Apr
Apr
Nov
Oct

04,
04,
20,
19,

2017
2017
2018
2015

DABIGATRAN ETEXILATE MESYLATE - PRADAXA

N 022512 002 6087380
Feb 18,
7866474
Aug 31,
7932273
Sep 07,
9034822
Jan 20,

2018
2027
2025
2031

DS DP U-1089
DP
DS DP
U-1759

I-682
I-683
M-168
NCE

Apr
Apr
Nov
Oct

04,
04,
20,
19,

2017
2017
2018
2015

ADA 44 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
DABIGATRAN ETEXILATE MESYLATE - PRADAXA
N 022512 003 6087380
Feb 18, 2018
7866474
Aug 31, 2027
7932273
Sep 07, 2025
9034822
Jan 20, 2031

DS DP U-1089
DP
DS DP
U-1759

NS

Nov 20, 2018

DABRAFENIB MESYLATE - TAFINLAR

N 202806 001 7994185
8415345
8703781

Jan 20, 2030

Jan 20, 2030
Oct 15, 2030

DS DP U-1406
DS DP U-1406
DS DP U-1713

I-678
NCE
ODE
ODE

Jan
May
May
Jan

08,
29,
29,
09,

2017
2018
2020
2021

DABRAFENIB MESYLATE - TAFINLAR

N 202806 002 7994185
8415345
8703781

Jan 20, 2030

Jan 20, 2030
Oct 15, 2030

DS DP U-1406
DS DP U-1406
DS DP U-1713

I-678
NCE
ODE
ODE

Jan
May
May
Jan

08,
29,
29,
09,

2017
2018
2020
2021

APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DACLATASVIR DIHYDROCHLORIDE - DAKLINZA

N 206843 001 8329159
Apr 13,
8629171
Jun 13,
8642025
Aug 11,
8642025
Aug 11,
8900566
Aug 08,
8900566
Aug 08,

2028
2031
2027
2027
2027
2027

DS
DS DP U-1724
DS DP U-1724
DS DP U-1725
U-1724
U-1725

NCE

Jul 24, 2020

DACLATASVIR DIHYDROCHLORIDE - DAKLINZA

N 206843 002 8329159
Apr 13,
8629171
Jun 13,
8642025
Aug 11,
8642025
Aug 11,
8900566
Aug 08,
8900566
Aug 08,

2028
2031
2027
2027
2027
2027

DS
DS DP U-1724
DS DP U-1724
DS DP U-1725
U-1724
U-1725

NCE

Jul 24, 2020

NCE
GAIN

May 23, 2019

May 23, 2024

ODE

Jan 22, 2017

ODE

Jul 22, 2021

DS DP U-493
DS DP U-493
U-493
DP
DS
DP
U-493
DP U-493
U-1522
DP
U-493

M-157
NCE

Mar 11, 2018

Jan 08, 2019

DS DP U-493
DS DP U-493
U-493

M-157
NCE

Mar 11, 2018

Jan 08, 2019

DALBAVANCIN HYDROCHLORIDE - DALVANCE

N 021883 001 6900175
Dec 25, 2023
7115564
Nov 14, 2023
7119061
Nov 14, 2023
8143212
Nov 14, 2023
DALFAMPRIDINE - AMPYRA
N 022250 001 5540938
8007826
8354437
8440703
8663685

Jul
May
Dec
Apr
Jan

30,
26,
22,
08,
18,

2018
2027
2026
2025
2025

DANTROLENE SODIUM - RYANODEX

N 205579 001 7758890
8110225
8604072
8685460

Jul
Dec
Dec
Feb

01,
24,
24,
15,

2025
2022
2022
2023

DAPAGLIFLOZIN PROPANEDIOL - FARXIGA

N 202293 001 6414126
Oct
6515117
Oct
6936590
Oct
7851502
Aug
7919598
Dec
8221786
Mar
8361972
Mar
8501698
Jun
8685934
May
8716251
Mar
9198925
Oct

04,
04,
04,
19,
16,
21,
21,
20,
26,
21,
04,

2020
2020
2020
2028
2029
2028
2028
2027
2030
2028
2020

DAPAGLIFLOZIN PROPANEDIOL - FARXIGA

N 202293 002 6414126
Oct 04, 2020
6515117
Oct 04, 2020
6936590
Oct 04, 2020

U-1517
DP
DP
U-1517

U-1030
U-1030
U-1030
U-1030
U-1030

DP
DP
DP
U-1546

ADA 45 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
DAPAGLIFLOZIN PROPANEDIOL - FARXIGA

N 202293 002 7851502
Aug 19, 2028
7919598
Dec 16, 2029
8221786
Mar 21, 2028
8361972
Mar 21, 2028
8501698
Jun 20, 2027
8685934
May 26, 2030
8716251
Mar 21, 2028
9198925
Oct 04, 2020
PATENT NO

PATENT
CODES

DP

U-493

DP U-493

U-1522

DP

U-493

DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE - XIGDUO XR

N 205649 003 6414126
Oct 04, 2020
DS DP U-493
6515117
Oct 04, 2020
DS DP U-493

6936590
Oct 04, 2020
U-493

7919598
Dec 16, 2029
DS

8501698
Jun 20, 2027
DP U-493

8685934
May 26, 2030
U-1522

9198925
Oct 04, 2020
U-493

DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE - XIGDUO XR

N 205649 004 6414126
Oct 04, 2020
DS DP U-493
6515117
Oct 04, 2020
DS DP U-493

6936590
Oct 04, 2020
U-493

7919598
Dec 16, 2029
DS

8501698
Jun 20, 2027
DP U-493

8685934
May 26, 2030
U-1522

9198925
Oct 04, 2020
U-493

DAPTOMYCIN - CUBICIN

N 021572 001 6468967
6852689
8058238

Sep 24, 2019

Sep 24, 2019
Nov 28, 2020

DAPTOMYCIN - CUBICIN

N 021572 002 6468967
6852689
8003673
8058238
8129342
RE39071

Sep
Sep
Sep
Nov
Nov
Jun

24,
24,
04,
28,
28,
15,

EXCLUSIVITY

EXPIRATION

DATE

DP

DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE - XIGDUO XR

N 205649 002 6414126
Oct 04, 2020
DS DP U-493
6515117
Oct 04, 2020
DS DP U-493

6936590
Oct 04, 2020
U-493

7919598
Dec 16, 2029
DS

8501698
Jun 20, 2027
DP U-493

8685934
May 26, 2030
U-1522

9198925
Oct 04, 2020
U-493

Sep 11, 2016

Sep 11, 2016
Sep 11, 2016

EXCLUSIVITY
CODE(S)

DS

DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE - XIGDUO XR

N 205649 001 6414126
Oct 04, 2020
DS DP U-493
6515117
Oct 04, 2020
DS DP U-493

6936590
Oct 04, 2020
U-493

7919598
Dec 16, 2029
DS

8501698
Jun 20, 2027
DP U-493

8685934
May 26, 2030
U-1522

9198925
Oct 04, 2020
U-493

DAPSONE - ACZONE

N 021794 001 5863560
6060085
6620435

PATENT
DELIST
REQUESTED

DP

U-124

DP

U-282

U-282

DS DP

2019
2019
2028
2020
2020
2016

U-282

U-282

U-1180

DS DP

DS DP

DS DP U-728

DARIFENACIN HYDROBROMIDE - ENABLEX

N 021513 001 6106864
Aug 21, 2016

DP U-630

DARIFENACIN HYDROBROMIDE - ENABLEX

N 021513 002 6106864
Aug 21, 2016

DP U-630

NCE

Jan 08, 2019

NCE

Jan 08, 2019

NCE

Jan 08, 2019

NCE

Jan 08, 2019

ADA 46 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DARUNAVIR ETHANOLATE - PREZISTA

N 021976 001 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
8597876*PED
RE42889
RE43596
RE43802

Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Feb
Aug
Jun
Dec
Oct
May
Oct

01,
01,
01,
01,
01,
26,
26,
26,
26,
26,
26,
23,
23,
23,
26,
16,
16,
23,
23,
19,
09,
19,

2015
2015
2015
2015
2015
2016
2016
2016
2016
2016
2016
2019
2019
2019
2026
2024
2024
2019
2019
2016
2017
2016

DARUNAVIR ETHANOLATE - PREZISTA

N 021976 002 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
8597876*PED
RE42889
RE43596
RE43802

Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Feb
Aug
Jun
Dec
Oct
May
Oct

01,
01,
01,
01,
01,
26,
26,
26,
26,
26,
26,
23,
23,
23,
26,
16,
16,
23,
23,
19,
09,
19,

2015
2015
2015
2015
2015
2016
2016
2016
2016
2016
2016
2019
2019
2019
2026
2024
2024
2019
2019
2016
2017
2016

DARUNAVIR ETHANOLATE - PREZISTA

N 021976 003 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
8597876*PED
RE42889

Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Feb
Aug
Jun
Dec
Oct

01,
01,
01,
01,
01,
26,
26,
26,
26,
26,
26,
23,
23,
23,
26,
16,
16,
23,
23,
19,

2015
2015
2015
2015
2015
2016
2016
2016
2016
2016
2016
2019
2019
2019
2026
2024
2024
2019
2019
2016

PATENT
CODES
DP
DP
DP
DP
DP

U-744
U-903
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

D-135
PED

Feb 01, 2016

Aug 01, 2016

D-135
PED

Feb 01, 2016

Aug 01, 2016

D-135
PED

Feb 01, 2016

Aug 01, 2016

DS DP
DS DP
U-1305
DP
DS DP
U-1305

DP
DP
DP
DP
DP

U-744
U-903
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305

DS DP
DS DP
U-1305
DP
DS DP
U-1305

DP
DP
DP
DP
DP

U-744
U-903
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305

DS DP
DS DP
U-1305
DP

ADA 47 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DARUNAVIR ETHANOLATE - PREZISTA

N 021976 003 RE43596
RE43802

May 09, 2017

Oct 19, 2016

DARUNAVIR ETHANOLATE - PREZISTA

N 021976 004 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
8597876*PED
RE42889
RE43596
RE43802

Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Feb
Aug
Jun
Dec
Oct
May
Oct

01,
01,
01,
01,
01,
26,
26,
26,
26,
26,
26,
23,
23,
23,
26,
16,
16,
23,
23,
19,
09,
19,

2015
2015
2015
2015
2015
2016
2016
2016
2016
2016
2016
2019
2019
2019
2026
2024
2024
2019
2019
2016
2017
2016

DARUNAVIR ETHANOLATE - PREZISTA

N 021976 005 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
8597876*PED
RE42889
RE43596
RE43802

Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Feb
Aug
Jun
Dec
Oct
May
Oct

01,
01,
01,
01,
01,
26,
26,
26,
26,
26,
26,
23,
23,
23,
26,
16,
16,
23,
23,
19,
09,
19,

2015
2015
2015
2015
2015
2016
2016
2016
2016
2016
2016
2019
2019
2019
2026
2024
2024
2019
2019
2016
2017
2016

DARUNAVIR ETHANOLATE - PREZISTA

N 021976 006 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED

Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Feb
Aug

01,
01,
01,
01,
01,
26,
26,
26,
26,
26,
26,
23,
23,
23,
26,
16,
16,

2015
2015
2015
2015
2015
2016
2016
2016
2016
2016
2016
2019
2019
2019
2026
2024
2024

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS DP
U-1305

DP
DP
DP
DP
DP

U-744
U-903
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305

D-135
PED

Feb 01, 2016

Aug 01, 2016

D-135
PED

Feb 01, 2016

Aug 01, 2016

D-135
PED

Feb 01, 2016

Aug 01, 2016

DS DP
DS DP
U-1305
DP
DS DP
U-1305

DP
DP
DP
DP
DP

U-744
U-903
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305

DS DP
DS DP
U-1305
DP
DS DP
U-1305

DP
DP
DP
DP
DP

DS DP
DS DP

U-744
U-903
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305
U-935
U-1209
U-1305

ADA 48 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DARUNAVIR ETHANOLATE - PREZISTA

N 021976 006 8597876
8597876*PED
RE42889
RE43596
RE43802

Jun
Dec
Oct
May
Oct

23,
23,
19,
09,
19,

2019
2019

2016
2017
2016

DARUNAVIR ETHANOLATE - PREZISTA

N 202895 001 5843946
5843946
6037157
6037157
6703403
6703403
7470506
7470506
7700645
8518987
8518987*PED
8597876
8597876*PED
RE42889
RE43596
RE43802

Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Feb
Aug
Jun
Dec
Oct
May
Oct

01,
01,
26,
26,
26,
26,
23,
23,
26,
16,
16,
23,
23,
19,
09,
19,

2015
2015
2016
2016
2016
2016
2019
2019
2026
2024
2024

2019
2019

2016
2017
2016

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-1305

DP

DS DP

U-1305

DP U-1209
DP U-1305
U-1209

U-1305

U-1209

U-1305

U-1209

U-1305

DS DP

DS DP

D-135
PED

Feb 01, 2016

Aug 01, 2016

U-1305

DP

DS DP

U-1305

DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR - VIEKIRA PAK (COPACKAGED)

N 206619 001 6037157

Jun 26, 2016
U-1635
NCE
6703403
Jun 26, 2016
U-1635

7148359
Jul 19, 2019
DP

7364752
Nov 10, 2020
DP

8188104
May 17, 2029
DS DP U-1636

8268349
Aug 25, 2024
DP

8399015
Aug 25, 2024
DP

8420596
Apr 10, 2031
DS DP

8466159
Sep 04, 2032
U-1637

8492386
Sep 04, 2032
U-1637

8501238
Sep 17, 2028
DS DP U-1636

8642538
Sep 10, 2029
DS DP U-1638

8680106
Sep 04, 2032
U-1637

8685984
Sep 04, 2032
U-1637

8686026
Jun 09, 2031
DP

8691938
Apr 13, 2032
DS DP

9006387
Jun 10, 2030
U-1687

9044480
Apr 10, 2031
U-1638

9139536
Nov 09, 2028
U-1753

DASATINIB - SPRYCEL

N 021986 001 6596746
6596746
7125875
7125875
7153856
7491725
8680103

Jun
Jun
Apr
Apr
Apr
Mar
Feb

28,
28,
13,
13,
28,
28,
04,

2020
2020
2020
2020
2020
2026
2025

DS DP U-748

DS DP U-780

U-779

U-780

U-780

DS DP

DP

DASATINIB - SPRYCEL

N 021986 002 6596746
6596746
7125875
7125875
7153856
7491725
8680103

Jun
Jun
Apr
Apr
Apr
Mar
Feb

28,
28,
13,
13,
28,
28,
04,

2020
2020
2020
2020
2020
2026
2025

DS DP U-748

DS DP U-780

U-779

U-780

U-780

DS DP

DP

DASATINIB - SPRYCEL

N 021986 003 6596746
6596746
7125875
7125875
7153856

Jun
Jun
Apr
Apr
Apr

28,
28,
13,
13,
28,

2020
2020
2020
2020
2020

DS DP U-748

DS DP U-780

U-779

U-780

U-780

Dec 19, 2019

ADA 49 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DASATINIB - SPRYCEL
N 021986 003 7491725
8680103

Mar 28, 2026

Feb 04, 2025

DS DP
DP

DASATINIB - SPRYCEL
N 021986 004 6596746
6596746
7125875
7125875
7153856
7491725
8680103

Jun
Jun
Apr
Apr
Apr
Mar
Feb

28,
28,
13,
13,
28,
28,
04,

2020
2020
2020
2020
2020
2026
2025

DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
DP

DASATINIB - SPRYCEL
N 021986 005 6596746
6596746
7125875
7125875
7153856
7491725
8680103

Jun
Jun
Apr
Apr
Apr
Mar
Feb

28,
28,
13,
13,
28,
28,
04,

2020
2020
2020
2020
2020
2026
2025

DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
DP

DASATINIB - SPRYCEL
N 021986 006 6596746
6596746
7125875
7125875
7153856
7491725
8680103

Jun
Jun
Apr
Apr
Apr
Mar
Feb

28,
28,
13,
13,
28,
28,
04,

2020
2020
2020
2020
2020
2026
2025

DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
DP

DEFERASIROX - EXJADE
N 021882 001 6465504
6596750

Apr 05, 2019

Jun 24, 2017

DS DP
DS
U-735

I-665
ODE

Jan 23, 2016

Jan 23, 2020

DEFERASIROX - EXJADE
N 021882 002 6465504
6596750

Apr 05, 2019

Jun 24, 2017

DS DP
DS
U-735

I-665
ODE

Jan 23, 2016

Jan 23, 2020

DEFERASIROX - EXJADE
N 021882 003 6465504
6596750

Apr 05, 2019

Jun 24, 2017

DS DP
DS
U-735

I-665
ODE

Jan 23, 2016

Jan 23, 2020

DEFERASIROX - JADENU
N 206910 001 6465504
6596750

Apr 05, 2019

Jun 24, 2017

DS DP
DS
U-735

DEFERASIROX - JADENU
N 206910 002 6465504
6596750

Apr 05, 2019

Jun 24, 2017

DS DP
DS
U-735

DEFERASIROX - JADENU
N 206910 003 6465504
6596750

Apr 05, 2019

Jun 24, 2017

DS DP
DS
U-735

DEFERIPRONE - FERRIPROX
N 021825 001 7049328

Jun 28, 2021

U-735

NCE
ODE

Oct 14, 2016

Oct 14, 2018

DEFERIPRONE - FERRIPROX
N 208030 001 7049328
8703156

Jun 28, 2021

Oct 29, 2029

U-735
DP U-735

NCE
ODE

Oct 14, 2016

Oct 14, 2016

DEGARELIX ACETATE - FIRMAGON

N 022201 001 5925730

May 18, 2021

DS DP U-943

DEGARELIX ACETATE - FIRMAGON

N 022201 002 5925730

May 18, 2021

DS DP U-943

ADA 50 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
DELAVIRDINE MESYLATE - RESCRIPTOR

N 020705 002 6177101
Jun 07, 2019

PATENT NO

PATENT
CODES

DEOXYCHOLIC ACID - KYBELLA

N 206333 001 7622130
7754230
8101593
8242294
8298556
8367649
8461140
8546367
8653058
8846066
8883770

Dec
Dec
Mar
May
Aug
Mar
Feb
Feb
Mar
Feb
Feb

DESLORATADINE - CLARINEX
N 021165 001 6100274
7405223

Jul 07, 2019

Jul 07, 2019

DESLORATADINE - CLARINEX
N 021300 001 6514520

Jun 01, 2018

DP

DESLORATADINE - CLARINEX
N 021312 001 6100274
7618649

Jul 07, 2019

Dec 19, 2020

DP
DP U-1017

DESLORATADINE - CLARINEX
N 021312 002 6100274
7618649

Jul 07, 2019

Dec 19, 2020

DP
DP U-1017

10,
10,
02,
16,
03,
02,
21,
21,
02,
08,
21,

2027
2027
2030
2028
2025
2030
2028
2028
2030
2025
2028

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-1690
U-1690
DP
DS
U-1690
DP
DP
DP U-1690
DP
U-1690
DP

U-886

DESLORATADINE; PSEUDOEPHEDRINE SULFATE N 021313 001 6100274

Jul 07,
6709676
Feb 18,
7618649
Dec 19,
8187630
Dec 19,

CLARINEX-D
2019
2021
2020
2020

DESLORATADINE; PSEUDOEPHEDRINE SULFATE N 021605 001 6100274

Jul 07,
6979463
Mar 28,
7618649
Dec 19,
7820199
Mar 28,

CLARINEX D 24 HOUR

2019
DP

2022
DP

2020
DP U-1017

2022
DP

12 HOUR

DP

DP U-707

DP U-1017

DP U-1017

DESONIDE - DESONATE

N 021844 001 6387383

Aug 03, 2020

DESONIDE - VERDESO

N 021978 001 6730288
7029659
8460641
8962000

Sep
Sep
Nov
Aug

2019
2019
2028
2025

DP

DP

DP U-1412

DP U-1412

DESOXIMETASONE - TOPICORT

N 204141 001 5990100
8277780
8715624

Mar 24, 2018

Sep 01, 2028
May 26, 2026

DP U-1408

DP U-1408

DP U-1408

08,
08,
05,
31,

PATENT
DELIST
REQUESTED

DS DP U-783

NDF

Apr 11, 2016

DESVENLAFAXINE SUCCINATE - PRISTIQ

N 021992 001 6673838
Mar 01, 2022
6673838
Mar 01, 2022
8269040
Jul 05, 2027

DS
DS
DS

U-860

U-1364

I-675

Feb 14, 2016

DESVENLAFAXINE SUCCINATE - PRISTIQ

N 021992 002 6673838
Mar 01, 2022
6673838
Mar 01, 2022
8269040
Jul 05, 2027

DS
DS
DS

U-860

U-1364

I-675

Feb 14, 2016

DESVENLAFAXINE SUCCINATE - PRISTIQ

N 021992 003 6673838
Mar 01, 2022
6673838
Mar 01, 2022
8269040
Jul 05, 2027

DS
DS
DS

U-860
U-1364

ADA 51 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
DESVENLAFAXINE SUCCINATE - PRISTIQ

N 021992 003 6673838
Mar 01, 2022
6673838
Mar 01, 2022
8269040
Jul 05, 2027
PATENT NO

DEXAMETHASONE - OZURDEX

N 022315 001 6726918
6726918
6899717
7033605
7767223
8034366
8034366
8034370
8043628
8063031
8088407
8506987
8506987
9012437
9192511

Oct
Oct
Nov
Oct
Nov
Jan
Jan
Jan
Oct
Oct
Oct
Jan
Jan
Oct
Jan

20,
20,
01,
20,
28,
09,
09,
09,
20,
20,
20,
09,
09,
20,
09,

PATENT
CODES
DS
DS
DS

DP U-1204
DP U-1205
U-1206

DP

DP

DP U-1204

DP U-1205

DP

U-1205

DP

U-1205

U-1204

U-1205

U-1205

DP

DEXAMETHASONE; TOBRAMYCIN - TOBRADEX ST

N 050818 001 7795316
Aug 03, 2028
8101582
Dec 19, 2027

DP U-1082

DP U-1082

Jun
Jun
Jun
Jan
Jan
Jan
Jan
Jul
Jun
Jun
Jun
Jun
Aug
Sep
Mar
Mar
Mar
Jan
Jul
Oct
Apr
Oct
Oct
Oct
Apr
Jan
Feb
Jun

15,
15,
15,
30,
30,
30,
30,
30,
15,
15,
15,
15,
02,
27,
17,
17,
17,
17,
17,
15,
15,
15,
15,
15,
15,
11,
24,
15,

2020
2020
2020
2023
2023
2023
2023
2023

2020
2020
2020
2020
2026
2026
2030
2030
2030
2026
2026

2023
2024

2023
2023
2023
2024

2028
2026
2020

DS
DS
DS
DS
DS
DS
DS

DEXLANSOPRAZOLE - DEXILANT

N 022287 002 6462058
6462058
6462058
6664276
6664276
6664276
6664276
6664276*PED
6939971
6939971
6939971
7285668
7790755

Jun
Jun
Jun
Jan
Jan
Jan
Jan
Jul
Jun
Jun
Jun
Jun
Aug

15,
15,
15,
30,
30,
30,
30,
30,
15,
15,
15,
15,
02,

2020
2020
2020
2023
2023
2023
2023
2023

2020
2020
2020
2020
2026

DS
DS
DS
DS
DS
DS
DS

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-860

U-1364

2020
2020
2023
2020
2021
2023
2023
2023
2020
2020
2020
2023
2023
2020
2023

DEXLANSOPRAZOLE - DEXILANT

N 022287 001 6462058
6462058
6462058
6664276
6664276
6664276
6664276
6664276*PED
6939971
6939971
6939971
7285668
7790755
8105626
8173158
8173158
8173158
8461187
8461187*PED
8722084
8722084*PED
8784885
8784885
8784885
8784885*PED
8871273
9011926
9145389

PATENT
DELIST
REQUESTED

DP
DP
DP
DP
DP
DP
DP

U-949

U-950

U-951

U-949

U-950

U-951

U-1507

U-949

U-950

U-951

DS

DP

DP

U-949

U-950

U-951

DP

DP

DP U-1552

DP U-1553

DP U-1554

DP

DP

DS DP

DP
DP
DP
DP
DP
DP
DP

U-949

U-950

U-951

U-949

U-950

U-951

U-1507

U-949

U-950

U-951

DS

DP

I-686
ODE

Jun 29, 2017

Sep 24, 2017

ADA 52 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

DEXLANSOPRAZOLE - DEXILANT
N 022287 002 8105626
8173158
8173158
8173158
8461187
8461187*PED
8722084
8722084*PED
8784885
8784885
8784885
8784885*PED
8871273
9011926
9145389

PATENT
EXPIRATION
DATE
Sep
Mar
Mar
Mar
Jan
Jul
Oct
Apr
Oct
Oct
Oct
Apr
Jan
Feb
Jun

27,
17,
17,
17,
17,
17,
15,
15,
15,
15,
15,
15,
11,
24,
15,

2026
2030
2030
2030
2026
2026
2023
2024
2023
2023
2023
2024
2028
2026
2020

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
U-949
U-950
U-951
DP
DP
DP U-1552
DP U-1553
DP U-1554
DP
DP
DS DP

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX

N 021038 001 6716867
Mar 31, 2019
6716867*PED
Oct 01, 2019

U-1472

M-61
PED

Jun 17, 2016

Dec 17, 2016

U-1472

M-61
PED

Jun 17, 2016

Dec 17, 2016

M-61
PED

Jun 17, 2016

Dec 17, 2016

DEXMETHYLPHENIDATE HYDROCHLORIDE - DEXMETHYLPHENIDATE HYDROCHLORIDE

A 078908 002

PC

Aug 01, 2015

DEXMETHYLPHENIDATE HYDROCHLORIDE - DEXMETHYLPHENIDATE HYDROCHLORIDE

A 078908 003

PC

Dec 19, 2015

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX

N 021038 002 6716867
Mar 31, 2019
6716867*PED
Oct 01, 2019
8242158
Jan 04, 2032
8242158*PED
Jul 04, 2032
8338470
Jan 04, 2032
8338470*PED
Jul 04, 2032
8455527
Jan 04, 2032
8455527*PED
Jul 04, 2032
8648106
Jan 04, 2032
8648106*PED
Jul 04, 2032
DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX
N 021038 003 6716867
Mar 31, 2019
6716867*PED
Oct 01, 2019
8242158
Jan 04, 2032
8242158*PED
Jul 04, 2032
8338470
Jan 04, 2032
8338470*PED
Jul 04, 2032
8455527
Jan 04, 2032
8455527*PED
Jul 04, 2032
8648106
Jan 04, 2032
8648106*PED
Jul 04, 2032
DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX
N 021038 004 6716867
Mar 31, 2019
6716867*PED
Oct 01, 2019
8242158
Jan 04, 2032
8242158*PED
Jul 04, 2032
8338470
Jan 04, 2032
8338470*PED
Jul 04, 2032
8455527
Jan 04, 2032
8455527*PED
Jul 04, 2032
8648106
Jan 04, 2032
8648106*PED
Jul 04, 2032

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021278 001 5908850
6355656
6528530

- FOCALIN
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015

DP
DP
U-421
DP

U-1472
DP
DP
U-421
DP

U-1472
DP
DP
U-421
DP

U-422
DS DP

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 53 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N 021278 002 5908850
Dec 04, 2015
6355656
Dec 04, 2015
6528530
Dec 04, 2015
PATENT NO

PATENT
CODES
U-422
DS DP

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021278 003 5908850
6355656
6528530

- FOCALIN
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021802 001 5837284
5908850
6228398
6355656
6528530
6635284
6730325
7431944

- FOCALIN XR
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021802 002 5837284
5908850
6228398
6355656
6528530
6635284
6730325
7431944

- FOCALIN XR
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021802 003 5837284
5908850
6228398
6355656
6528530
6635284
6730325
7431944

- FOCALIN XR
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021802 004 5837284
5908850
6228398
6355656
6528530
6635284
6730325
7431944

- FOCALIN XR
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021802 005 5837284
5908850
6228398
6355656
6528530
6635284
6730325
7431944

- FOCALIN XR
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015

DP
DP
DP
DP
DP
DP
DP
DP

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021802 006 5837284
5908850
6228398
6355656
6528530
6635284
6730325
7431944

- FOCALIN XR
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015

DP
DP
DP
DP
DP
DP
DP
DP

U-422
DS DP

DP
U-678
DP U-676
DP
DP
DP U-677
DP U-676
DP

DP
U-678
DP U-676
DP
DP
DP U-677
DP U-676
DP

DP
U-678
DP U-676
DP
DP
DP U-677
DP U-676
DP

DP
U-678
DP U-676
DP
DP
DP U-677
DP U-676
DP

U-678
U-676

U-677
U-676

U-677
U-678
U-676

U-677
U-676

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 54 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 007 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015
APPL/PROD
NO

PATENT NO

DEXMETHYLPHENIDATE HYDROCHLORIDE
N 021802 008 5837284
5908850
6228398
6355656
6528530
6635284
6730325
7431944

- FOCALIN XR
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015

PATENT
CODES
DP
DP
DP
DP
DP
DP
DP
DP

DP
DP
DP
DP
DP
DP
DP
DP

DEXRAZOXANE HYDROCHLORIDE - TOTECT

N 022025 001 6727253
Mar 13, 2020

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-678
U-676

U-677
U-676

U-678
U-676

U-677
U-676

U-829

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - MUCINEX DM

N 021620 001 6372252
Apr 28, 2020
DP
6955821
Apr 28, 2020
DP U-685
7838032
Apr 28, 2020
DP
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - MUCINEX DM
N 021620 002 6372252
Apr 28, 2020
DP
6955821
Apr 28, 2020
DP U-685
7838032
Apr 28, 2020
DP
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE - NUEDEXTA
N 021879 001 7659282
Aug 13, 2026
U-1093
8227484
Jul 17, 2023
U-1093
RE38115
Jan 26, 2016
DP
DEXTROMETHORPHAN POLISTIREX - DELSYM
N 018658 001 5980882
Apr 16, 2017

DP

DICHLORPHENAMIDE - KEVEYIS
N 011366 002
DICLOFENAC - ZORVOLEX
N 204592 001 8679544
8999387
9017721
9173854
9180095
9180096
9186328

Apr
Apr
Apr
Apr
Apr
Apr
Apr

23,
23,
23,
23,
23,
23,
23,

2030
2030
2030
2030
2030
2030
2030

DP

DICLOFENAC - ZORVOLEX
N 204592 002 8679544
8999387
9017721
9173854
9180095
9180096
9186328

Apr
Apr
Apr
Apr
Apr
Apr
Apr

23,
23,
23,
23,
23,
23,
23,

2030
2030
2030
2030
2030
2030
2030

DP

DICLOFENAC EPOLAMINE - FLECTOR

N 021234 001 5607690

Apr 13, 2019

DP

DICLOFENAC POTASSIUM - CAMBIA

N 022165 001 6974595
7482377
7759394
8097651

May
May
Jun
Jun

15,
15,
16,
16,

2017
2017
2026
2026

U-55

ODE

Aug 07, 2022

I-692
NP

Aug 22, 2017

Oct 18, 2016

I-692
NP

Aug 22, 2017

Oct 18, 2016

DP
DP
U-55
DP
U-55

U-55
DP
DP
U-55
DP
U-55

U-436
DS DP U-436
DS DP U-436
DS DP U-436

ADA 55 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DICLOFENAC POTASSIUM - CAMBIA

N 022165 001 8927604

Jun 16, 2026

DICLOFENAC POTASSIUM - ZIPSOR

N 022202 001 6287594
6365180
7662858
7884095
7939518
8110606
8623920

Jan
Jul
Feb
Feb
Feb
Feb
Feb

15,
15,
24,
24,
24,
24,
24,

2019
2019
2029
2029
2029
2029
2029

DP

DP U-980

U-1035

U-1111

U-980

U-980

U-1482

DICLOFENAC SODIUM - PENNSAID

N 020947 001 8217078
8546450
8546450
8618164
8741956

Jul
Aug
Aug
Jul
Jul

10,
09,
09,
10,
10,

2029
2030
2030
2029
2029

U-1248

U-1435

U-1436

U-1477

U-1435

DICLOFENAC SODIUM - SOLARAZE

N 021005 001 5792753
5914322
5985850

Aug 11, 2015

Aug 11, 2015

Aug 11, 2015

DICLOFENAC SODIUM - DYLOJECT

N 022396 001 6407079
8946292

Jun 18, 2019

Mar 22, 2027

DP

DICLOFENAC SODIUM - PENNSAID

N 204623 001 8217078
8252838
8546450
8546450
8563613
8618164
8741956
8871809
9066913
9101591
9132110
9168304
9168305

Jul
Apr
Aug
Aug
Oct
Jul
Jul
Oct
Oct
Oct
Oct
Oct
Oct

U-1477
DP U-1489

U-1435

U-1436

DP U-1488

U-1477

U-1435

U-1614

DP U-1488

DP U-1488

U-1488

DP

U-1488

10,
21,
09,
09,
17,
10,
10,
17,
17,
17,
17,
17,
17,

2029
2028
2030
2030
2027
2029
2029
2027
2027
2027
2027
2027
2027

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-436

DP

NP

Dec 23, 2017

NP

Jan 16, 2017

U-1659

DIENOGEST; DIENOGEST; DIENOGEST; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL

VALERATE; ESTRADIOL VALERATE - NATAZIA

N 022252 001 6133251
Oct 25, 2016
DP U-1
Y

6133251
Oct 25, 2016
DP U-112
Y

6133251
Oct 25, 2016
DP U-828
Y

6884793
Oct 25, 2016
DP
Y

8071577
May 13, 2026
DP U-1

8153616
Jan 30, 2028
U-1240

DIFLUPREDNATE - DUREZOL

N 022212 001 6114319
6114319*PED

May 18, 2019

Nov 18, 2019

DP

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N 021392 001 6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP

DP U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N 021392 002 6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP

DP U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N 021392 003 6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP

DP U-107

M-127
ODE
PED
PED
PED

Mar
Jun
Dec
Sep
Dec

22,
13,
13,
22,
13,

2016

2019

2015

2016

2019

ADA 56 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 004 6923984
Feb 25, 2021
7108866
Dec 17, 2019
APPL/PROD
NO

PATENT NO

PATENT
CODES

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N 021392 005 6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP
DP U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N 021392 006 6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP
DP U-107

DIMETHYL FUMARATE - TECFIDERA

N 204063 001 6509376
7320999
7619001
7803840
8399514
8524773
8759393

Oct
May
Apr
Apr
Feb
Apr
Oct

29,
18,
01,
01,
07,
01,
29,

2019
2020
2018
2018
2028
2018
2019

DP

DIMETHYL FUMARATE - TECFIDERA

N 204063 002 6509376
7320999
7619001
7803840
8399514
8524773
8759393

Oct
May
Apr
Apr
Feb
Apr
Oct

29,
18,
01,
01,
07,
01,
29,

2019
2020
2018
2018
2028
2018
2019

DP

NCE

Mar 27, 2018

NCE

Mar 27, 2018

NC

Jan 17, 2017

U-1384
U-1384
U-1385
U-1384
U-1384
DP

U-1384
U-1384
U-1385
U-1384
U-1384
DP

DIMYRISTOYL LECITHIN; PERFLEXANE - IMAGENT

N 021191 001 5798091
Aug 25, 2015
DIPHENHYDRAMINE CITRATE; IBUPROFEN - ADVIL PM
N 021394 001 8263647
May 30, 2022

PATENT
DELIST
REQUESTED

U-458

DP

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN - ADVIL PM

N 021393 001 8883849
Jan 17, 2022
U-1618
9155718
Jan 17, 2022
DP
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM - ALEVE PM
N 205352 001
DIVALPROEX SODIUM - DEPAKOTE ER
N 021168 001 6419953
6511678
6528090
6528091
6713086
6720004

Dec
Dec
Dec
Dec
Dec
Dec

18,
18,
18,
18,
18,
18,

2018
2018
2018
2018
2018
2018

DIVALPROEX SODIUM - DEPAKOTE ER

N 021168 002 6511678
6528090
6713086
6720004

Dec
Dec
Dec
Dec

18,
18,
18,
18,

2018
2018
2018
2018

DOCETAXEL - DOCETAXEL
N 205934 001 8940786

Sep 30, 2033

DP U-1789

DOCETAXEL - DOCETAXEL
N 205934 002 8940786

Sep 30, 2033

DP U-1789

DOCETAXEL - DOCETAXEL
N 205934 003 8940786

Sep 30, 2033

DP U-1789

DOFETILIDE - TIKOSYN
N 020931 001 6124363

Oct 09, 2018

DP
U-106
DP U-579
DP

DP
DP U-579
DP

ADA 57 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DOFETILIDE - TIKOSYN
N 020931 002 6124363

Oct 09, 2018

DOFETILIDE - TIKOSYN
N 020931 003 6124363

Oct 09, 2018

DOLUTEGRAVIR SODIUM - TIVICAY

N 204790 001 8129385

Oct 05, 2027

PATENT
CODES

DS DP

EXCLUSIVITY
CODE(S)

M-166
NCE

DONEPEZIL HYDROCHLORIDE - ARICEPT ODT

N 021720 001 7727548
Jun 23, 2022
7727552
Mar 26, 2018

DP U-1062
DP

DONEPEZIL HYDROCHLORIDE - ARICEPT ODT

N 021720 002 7727548
Jun 23, 2022
7727552
Mar 26, 2018

DP U-1062
DP

DONEPEZIL HYDROCHLORIDE - ARICEPT

N 022568 001 8481565
Oct 04, 2026

DP

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - NAMZARIC

N 206439 001 5061703*PED
Oct 11, 2015
8058291
Dec 05, 2029
U-1641
8168209
Nov 22, 2025
DP
8168209*PED
May 22, 2026
8173708
Nov 22, 2025
U-1641
8173708*PED
May 22, 2026
8283379
Nov 22, 2025
U-1641
8283379*PED
May 22, 2026
8293794
Nov 22, 2025
DP
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - NAMZARIC
N 206439 002 5061703*PED
Oct 11, 2015
8039009
Mar 24, 2029
U-1641
8039009*PED
Sep 24, 2029
8058291
Dec 05, 2029
U-1641
8168209
Nov 22, 2025
DP
8168209*PED
May 22, 2026
8173708
Nov 22, 2025
U-1641
8173708*PED
May 22, 2026
8283379
Nov 22, 2025
U-1641
8283379*PED
May 22, 2026
8293794
Nov 22, 2025
DP
8329752
Nov 22, 2025
DP
8329752*PED
May 22, 2026
8338485
Nov 22, 2025
DP
8338486
Nov 22, 2025
U-1641
8362085
Nov 22, 2025
U-1641
8362085*PED
May 22, 2026
8580858
Nov 22, 2025
U-1641
8598233
Nov 22, 2025
DP
8598233*PED
May 22, 2026
DORIPENEM - DORIBAX
N 022106 001 8247402

Mar 30, 2021

DS DP

DORIPENEM - DORIBAX
N 022106 002 8247402

Mar 30, 2021

DS DP

DOXEPIN HYDROCHLORIDE - SILENOR

N 022036 001 6211229
7915307
8513299
9107898

Feb
Aug
Apr
May

2020
2027
2030
2028

U-620
U-620
U-620
DP U-620

DOXEPIN HYDROCHLORIDE - SILENOR

N 022036 002 6211229
7915307
8513299

Feb 17, 2020

Aug 24, 2027
Apr 14, 2030

U-620
U-620
U-620

17,
24,
14,
01,

PATENT
DELIST
REQUESTED

EXCLUSIVITY
EXPIRATION
DATE

Jul 30, 2018

Aug 12, 2018

ADA 58 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DOXEPIN HYDROCHLORIDE - SILENOR

N 022036 002 9107898

May 01, 2028

DP U-620

DOXERCALCIFEROL - HECTOROL
N 020862 001 6903083

Jul 18, 2021

DS DP

DOXERCALCIFEROL - HECTOROL
N 020862 002 6903083

Jul 18, 2021

DS DP

DOXYCYCLINE - ORACEA
N 050805 001 5789395
5919775
7211267
7232572
7749532
8206740
8394405
8394406
8470364
8603506
8709478

Aug
Aug
Apr
Apr
Dec
Dec
Apr
Apr
Apr
Apr
Apr

DOXYCYCLINE HYCLATE - DORYX

N 050795 001 6958161
8715724

Dec 15, 2022

Feb 03, 2028

DP U-918
DP

DOXYCYCLINE HYCLATE - DORYX

N 050795 002 6958161
8715724

Dec 15, 2022

Feb 03, 2028

DP U-918
DP

DOXYCYCLINE HYCLATE - DORYX

N 050795 003 6958161
8715724

Dec 15, 2022

Feb 03, 2028

DP U-918
DP

DOXYCYCLINE HYCLATE - DORYX

N 050795 004 6958161
8715724

Dec 15, 2022

Feb 03, 2028

DP U-918
DP

DOXYCYCLINE HYCLATE - DORYX

N 050795 005 6958161
8715724

Dec 15, 2022

Feb 03, 2028

DP U-918
DP

DOXYCYCLINE HYCLATE - DOXTERIC

N 050795 006 6958161
8715724

Dec 15, 2022

Feb 03, 2028

DP U-918
DP

PATENT NO

30,
30,
05,
05,
19,
24,
07,
07,
07,
05,
07,

2016
2016
2022
2022
2027
2025
2024
2024
2024
2022
2024

DP
DP
DP
DP
DP

U-925
U-925
U-925
U-925
U-1063
U-925
U-925
U-925
U-925
U-1063
U-1063

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE - DICLEGIS

N 021876 001 6340695
Jun 21, 2021
DP U-1382
7560122
Jan 25, 2019
DP
DRONEDARONE HYDROCHLORIDE - MULTAQ
N 022425 001 5223510
Jul
5223510
Jul
7323493
Jun
8318800
Jun
8410167
Apr
8410167
Apr
8602215
Jun
9107900
Apr
9107900
Apr

26,
26,
19,
19,
16,
16,
30,
16,
16,

2016
2016
2018
2018
2029
2029
2031
2029
2029

DS DP U-992
DS DP U-1261
DP
DP
U-1387
U-1388
U-1473
U-1726
U-1728

DROSPIRENONE; ESTRADIOL - ANGELIQ

N 021355 001 8906890
Oct 22, 2031

DP

DROSPIRENONE; ESTRADIOL - ANGELIQ

N 021355 002 6933395
Aug 11, 2017

DS

DROSPIRENONE; ETHINYL ESTRADIOL - YASMIN

N 021098 001 6787531
Aug 31, 2020
6933395
Aug 11, 2017

DS

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

Y
Y

D-136
NS

Apr 11, 2016

Apr 11, 2016

NP

Apr 08, 2016

ADA 59 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
DROSPIRENONE; ETHINYL ESTRADIOL - YAZ
N 021676 001 5798338
Jul 10, 2015
6787531
Aug 31, 2020
6933395
Aug 11, 2017
6958326
Dec 20, 2021
6987101
Dec 22, 2017
7163931
Dec 20, 2021
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP
DP
DP
U-758
U-1

DROSPIRENONE; ETHINYL ESTRADIOL;

N 022532 001 5798338
6441168
6958326
7163931
8617597

LEVOMEFOLATE CALCIUM - BEYAZ

Jul 10, 2015
DP
Jul 30, 2022
DS
Dec 20, 2021
DP
Mar 03, 2022
U-1
Feb 08, 2030
DP

DROSPIRENONE; ETHINYL ESTRADIOL;

N 022574 001 5798338
6441168
6958326
7163931
8617597

LEVOMEFOLATE CALCIUM - SAFYRAL

Jul 10, 2015
DP
Apr 17, 2020
DS
Dec 20, 2021
DP
Mar 03, 2022
U-1
Feb 08, 2030
DP

DROXIDOPA - NORTHERA
N 203202 001

DROXIDOPA - NORTHERA
N 203202 002

DROXIDOPA - NORTHERA
N 203202 003

DULOXETINE HYDROCHLORIDE - DULOXETINE HYDROCHLORIDE

A 090694 003

NCE
ODE

Feb 18, 2019

Feb 18, 2021

NCE
ODE

Feb 18, 2019

Feb 18, 2021

NCE
ODE

Feb 18, 2019

Feb 18, 2021

PC

Jan 11, 2016

DULOXETINE HYDROCHLORIDE - CYMBALTA

N 021427 001 6596756
Sep 10, 2019

U-882

M-61
NPP
NPP
PED

Oct
Oct
Oct
Apr

18,
16,
16,
18,

2015
2017
2017
2016

DULOXETINE HYDROCHLORIDE - CYMBALTA

N 021427 002 6596756
Sep 10, 2019

U-882

M-61
NPP
NPP
PED

Oct
Oct
Oct
Apr

18,
16,
16,
18,

2015
2017
2017
2016

DULOXETINE HYDROCHLORIDE - CYMBALTA

N 021427 004 6596756
Sep 10, 2019

U-882

M-61
NPP
NPP
PED

Oct
Oct
Oct
Apr

18,
16,
16,
18,

2015
2017
2017
2016

NDF

Oct 24, 2016

NCE

Jan 08, 2020

DUTASTERIDE - AVODART
N 021319 001 5565467

Nov 20, 2015

DS DP

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE - JALYN

N 022460 001 5565467
Nov 20, 2015

DS DP

ECONAZOLE NITRATE - ECOZA

N 205175 001 5993830

Jan 16, 2018

EDOXABAN TOSYLATE - SAVAYSA

N 206316 001 7365205
9149532

Jun 12, 2023

Mar 28, 2028

DP U-1449

DS
DP

ADA 60 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

EDOXABAN TOSYLATE - SAVAYSA

N 206316 002 7365205
9149532

Jun 12, 2023

Mar 28, 2028

DS

EDOXABAN TOSYLATE - SAVAYSA

N 206316 003 7365205
9149532

Jun 12, 2023

Mar 28, 2028

DS

EFAVIRENZ - SUSTIVA

N 020972 001 6238695
6238695*PED
6555133
6555133*PED
6639071
6639071*PED
6939964
6939964*PED

Apr
Oct
Apr
Oct
Feb
Aug
Jan
Jul

06,
06,
06,
06,
14,
14,
20,
20,

2019
2019
2019
2019

2018
2018

2018
2018

EFAVIRENZ - SUSTIVA

N 020972 002 6238695
6238695*PED
6555133
6555133*PED
6639071
6639071*PED
6939964
6939964*PED

Apr
Oct
Apr
Oct
Feb
Aug
Jan
Jul

06,
06,
06,
06,
14,
14,
20,
20,

2019
2019

2019
2019

2018
2018

2018
2018

EFAVIRENZ - SUSTIVA

N 020972 003 6238695
6238695*PED
6555133
6555133*PED
6639071
6639071*PED
6939964
6939964*PED

Apr
Oct
Apr
Oct
Feb
Aug
Jan
Jul

06,
06,
06,
06,
14,
14,
20,
20,

2019
2019
2019
2019

2018
2018

2018
2018

EFAVIRENZ - SUSTIVA

N 021360 001 6639071
6639071*PED
6939964
6939964*PED

Feb
Aug
Jan
Jul

14,
14,
20,
20,

2018
2018

2018
2018

DS

EFAVIRENZ - SUSTIVA

N 021360 002 6639071
6639071*PED
6939964
6939964*PED

Feb
Aug
Jan
Jul

14,
14,
20,
20,

2018
2018
2018
2018

DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NCE

Jan 08, 2020

NCE

Jan 08, 2020

NPP
PED

May 02, 2016

Nov 02, 2016

NPP
PED

May 02, 2016

Nov 02, 2016

NPP
PED

May 02, 2016

Nov 02, 2016

DP

DP

DP
U-248

DS

DS

DP

U-248

DS

DS

DP
U-248

DS

DS

DS

DS

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - ATRIPLA

N 021937 001 5814639
Sep 29, 2015
DS DP

5914331
Jul 02, 2017
DS

5922695
Jul 25, 2017
DS
U-750

5922695
Jul 25, 2017
DS
U-1170

5935946
Jul 25, 2017
DS DP U-750

5935946
Jul 25, 2017
DS DP U-1170

5977089
Jul 25, 2017
DS DP U-750

5977089
Jul 25, 2017
DS DP U-1170

6043230
Jul 25, 2017
U-750

6043230
Jul 25, 2017
U-1170

6639071
Feb 14, 2018
DS

6639071*PED
Aug 14, 2018

6642245
Nov 04, 2020
U-750

6642245
Nov 04, 2020
U-1170

6703396
Mar 09, 2021
DS DP

6939964
Jan 20, 2018
DS

6939964*PED
Jul 20, 2018

8592397
Jan 13, 2024
DP U-750

8592397
Jan 13, 2024
DP U-1170

ADA 61 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
PATENT

EXPIRATION
DELIST

PATENT
DATE
REQUESTED

CODES
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - ATRIPLA

N 021937 001 8598185
May 01, 2028
DP

8716264
Jan 13, 2024
DP U-257

9018192
Jun 13, 2026
U-750

9018192
Jun 13, 2026
U-1170

PATENT NO

EFINACONAZOLE - JUBLIA

N 203567 001 7214506
8039494
8486978

Oct 05, 2021

Jul 08, 2030
Oct 24, 2030

U-281

U-281

DS DP U-876

ELETRIPTAN HYDROBROMIDE - RELPAX

N 021016 002 5545644
Dec 26, 2016
6110940
Aug 29, 2017

DS DP U-876

Apr 29, 2022

Apr 29, 2022
Apr 29, 2022

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 001 6280959
6280959
6280959
6280959
6280959*PED
7160870
7160870
7160870
7160870
7160870*PED
7332481
7332481
7332481
7332481
7332481*PED
7452874
7452874*PED
7473686
7473686
7473686
7473686
7473686*PED
7547719
7547719
7547719
7547719
7547719*PED
7790704
7790704
7790704
7790704
7790704*PED
7795293
7795293
7795293
7795293
7795293*PED
8052993
8052993
8052993
8052993
8052993*PED
8052994
8052994*PED
8062665

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,

2018
2018
2018
2018
2019

2022
2022
2022
2022
2023

2021
2021
2021
2021
2021

2021
2021

2021
2021
2021
2021
2021

2025
2025
2025
2025
2026

2021
2021
2021
2021
2021

2023
2023
2023
2023
2023

2027
2027
2027
2027
2028

2027
2028

2027

EXCLUSIVITY

EXPIRATION

DATE

NCE

Jun 06, 2019

NCE
ODE

Aug 19, 2019

Aug 19, 2021

D-149
I-664
I-711
ODE
ODE
PED
PED
PED

Jun
Nov
Jun
Nov
Aug
Dec
Dec
Feb

DP

ELETRIPTAN HYDROBROMIDE - RELPAX

N 021016 001 5545644
Dec 26, 2016
6110940
Aug 29, 2017

ELIGLUSTAT TARTRATE - CERDELGA

N 205494 001 6916802
7196205
7615573

EXCLUSIVITY
CODE(S)

U-1571

DS

U-1571

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DP U-1714

DP U-1714

11,
16,
11,
20,
26,
11,
11,
26,

2018

2015

2018

2015

2021

2018

2018

2022

ADA 62 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD

NO

PATENT NO

PATENT

EXPIRATION

DATE

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 001 8062665*PED

8071129

8071129*PED

8828430

8828430

8828430

8828430*PED

Feb
Aug
Feb
Aug
Aug
Aug
Feb

01,
01,
01,
01,
01,
01,
01,

2028

2027

2028

2027

2027

2027

2028

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 002 6280959

6280959

6280959

6280959

6280959*PED

7160870

7160870

7160870

7160870

7160870*PED

7332481

7332481

7332481

7332481

7332481*PED

7452874

7452874*PED

7473686

7473686

7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719

7547719*PED

7790704

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

7795293

7795293*PED

8052993

8052993*PED

8052994

8052994

8052994

8052994

8052994*PED

8062665

8062665*PED

8071129

8071129*PED

8828430

8828430

8828430

8828430*PED

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Feb

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2018

2018

2018

2018

2019

2022

2022

2022

2022

2023

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2025

2025

2025

2025

2026

2021

2021

2021

2021

2021

2023

2023

2023

2023

2023

2027

2028

2027

2027

2027

2027

2028

2027

2028

2027

2028

2027

2027

2027

2028

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 003 6280959

6280959

6280959

6280959

6280959*PED

Oct
Oct
Oct
Oct
Apr

30,
30,
30,
30,
30,

2018

2018

2018

2018

2019

PATENT
CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP U-1714

DP U-1306

DP U-1619

DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

D-149
I-664
I-711
ODE
ODE
PED
PED
PED

Jun
Nov
Jun
Nov
Aug
Dec
Dec
Feb

11,
16,
11,
20,
26,
11,
11,
26,

2018

2015

2018

2015

2021

2018

2018

2022

D-149
I-664
I-711
ODE
ODE

Jun
Nov
Jun
Nov
Aug

11,
16,
11,
20,
26,

2018

2015

2018

2015

2021

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DP U-1714

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DP U-1714

DP U-1714

DP U-1306

DP U-1619

DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

ADA 63 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD

NO

PATENT NO

PATENT

EXPIRATION

DATE

PATENT
CODES

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 003 7160870

7160870

7160870

7160870

7160870*PED

7332481

7332481

7332481

7332481

7332481*PED

7452874

7452874*PED

7473686

7473686

7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719

7547719*PED

7790704

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

7795293

7795293*PED

8052993

8052993*PED

8052994

8052994*PED

8062665

8062665

8062665

8062665

8062665*PED

8071129

8071129*PED

8828430

8828430

8828430

8828430*PED

Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Feb

20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2022

2022

2022

2022

2023

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2025

2025

2025

2025

2026

2021

2021

2021

2021

2021

2023

2023

2023

2023

2023

2027

2028

2027

2028

2027

2027

2027

2027

2028

2027

2028

2027

2027

2027

2028

DS
DS
DS
DS

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 004 6280959

6280959

6280959

6280959

6280959*PED

7160870

7160870

7160870

7160870

7160870*PED

7332481

7332481

7332481

7332481

7332481*PED

7452874

7452874*PED

7473686

7473686

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,

2018

2018

2018

2018

2019

2022

2022

2022

2022

2023

2021

2021

2021

2021

2021

2021

2021

2021

2021

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

PATENT

DELIST

REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PED
PED
PED

Dec 11, 2018

Dec 11, 2018

Feb 26, 2022

D-149
I-664
I-711
ODE
ODE
PED
PED
PED

Jun
Nov
Jun
Aug
Aug
Dec
Dec
Feb

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DP U-1714

DP U-1714

DP
DP
DP
DP

U-714

U-930

U-1306

U-1575

DP U-1714

DP U-1306

DP U-1619

DP U-1714

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS DP U-930

DS DP U-1306

11,
16,
11,
26,
26,
11,
11,
26,

2018

2015

2018

2021

2021

2018

2018

2022

ADA 64 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD

NO

PATENT NO

PATENT

EXPIRATION

DATE

PATENT
CODES

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 004 7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719

7547719*PED

7790704

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

7795293

7795293*PED

8052993

8052993*PED

8052994

8052994*PED

8062665

8062665*PED

8071129

8071129

8071129

8071129

8071129*PED

8828430

8828430

8828430

8828430*PED

May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Aug
Aug
Feb

24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2021

2021

2021

2025

2025

2025

2025

2026

2021

2021

2021

2021

2021

2023

2023

2023

2023

2023

2027

2028

2027

2028

2027

2028

2027

2027

2027

2027

2028

2027

2027

2027

2028

DS DP U-1575

DS DP U-1714

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 005 6280959

6280959

6280959

6280959

6280959*PED

7160870

7160870

7160870

7160870

7160870*PED

7332481

7332481

7332481

7332481

7332481*PED

7452874

7452874*PED

7473686

7473686

7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719*PED

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jan
May
May
May
Nov
May
May
May

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
24,
24,
24,
24,
21,
21,
21,

2018

2018

2018

2018

2019

2022

2022

2022

2022

2023

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2025

2025

2025

2026

2021

2021

2021

2021

2023

2023

2023

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306
U-1575
U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306
U-1575
U-1714

DS
DS
DS
DS

DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DP U-1714

DP U-1714

DP U-1714

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DP U-1306

DP U-1619

DP U-1714

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS DP U-930

DS DP U-1306

DS DP U-1575

U-930

U-1306

U-1575

U-930

U-1306

U-1575

D-149
I-664
I-711
ODE
ODE
PED
PED
PED

Jun
Nov
Jun
Aug
Aug
Dec
Dec
Feb

11,
16,
11,
26,
26,
11,
11,
26,

2018

2015

2018

2021

2021

2018

2018

2022

ADA 65 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ELTROMBOPAG OLAMINE - PROMACTA

N 022291 005 7795293*PED
8052995
8052995
8052995*PED

Nov
Aug
Aug
Feb

21,
01,
01,
01,

2023
2027
2027
2028

DP U-1306
DP U-1575

ELTROMBOPAG OLAMINE - PROMACTA

N 207027 001 6280959
7160870
7332481
7452874
7473686
7547719
7790704
7795293

Oct
Nov
May
May
May
Jul
May
May

30,
20,
24,
24,
24,
13,
24,
24,

2018
2022
2021
2021
2021
2025
2021
2023

DS DP U-1736
DS DP U-1736
U-1736
DS DP
DS DP U-1736
DS DP U-1736
U-1736
U-1736

D-149
I-711
ODE
PED
PED

Jun
Jun
Nov
Dec
Dec

ELUXADOLINE - VIBERZI
N 206940 001 7741356
7786158
8344011
8609709
8691860
9115091
9205076

Mar
Mar
Mar
Mar
Jul
Jul
Mar

25,
14,
14,
14,
07,
07,
14,

2028
2025
2025
2025
2028
2028
2025

DS DP
DS

NCE

May 27, 2020

ELUXADOLINE - VIBERZI
N 206940 002 7741356
7786158
8344011
8609709
8691860
9115091
9205076

Mar
Mar
Mar
Mar
Jul
Jul
Mar

25,
14,
14,
14,
07,
07,
14,

2028
2025
2025
2025
2028
2028
2025

DS DP
DS

NCE

May 27, 2020

ELVITEGRAVIR - VITEKTA
N 203093 001 7176220
7635704
8981103

Nov 20, 2023

Oct 26, 2026
Oct 26, 2026

DS DP U-257
DS DP U-257
DS DP

NP

Sep 24, 2017

ELVITEGRAVIR - VITEKTA
N 203093 002 7176220
7635704
8981103

Nov 20, 2023

Oct 26, 2026
Oct 26, 2026

DS DP U-257
DS DP U-257
DS DP

NP

Sep 24, 2017

EMPAGLIFLOZIN - JARDIANCE
N 204629 001 7579449
7713938

Nov 05, 2025

Apr 15, 2027

DS
DS DP

M-160
M-161
NCE

Jun 26, 2018

Jun 26, 2018
Aug 01, 2019

EMPAGLIFLOZIN - JARDIANCE
N 204629 002 7579449
7713938

Nov 05, 2025

Apr 15, 2027

DS
DS DP

M-160
M-161
NCE

Jun 26, 2018

Jun 26, 2018
Aug 01, 2019

NC
NCE
NCE

Jan 30, 2018

May 02, 2016
Aug 01, 2019

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI

N 206073 001 6303661
Apr 24,
6890898
Feb 02,
7078381
Feb 02,
7407955
Aug 12,
7459428
Feb 02,
7579449
Nov 05,
7713938
Apr 15,
8119648
Aug 12,
8178541
Aug 12,
8178541
Aug 12,
8551957
Oct 19,
8673927
May 04,
8846695
Jun 04,
8883805
Nov 26,
9173859
May 04,

2017
2019
2019
2023
2019
2025
2027
2023
2023
2023
2029
2027
2030
2025
2027

11,
11,
20,
11,
11,

2018
2018
2015
2018
2018

U-1709
DS
DS
U-1709
DS DP U-1738
U-1709

U-1709
DS
DS
U-1709
DS DP U-1738
U-1709

U-1651
U-1652
U-1651
DS DP
U-1651
DS
DS DP
DP
DP
DP
DP

U-1651
U-1653
U-1654
U-1651
U-1652
U-1652

DP
DP U-1772

ADA 66 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI

N 206073 001 6303661
Apr 24, 2017
6890898
Feb 02, 2019
7078381
Feb 02, 2019
7407955
Aug 12, 2023
7459428
Feb 02, 2019
7579449
Nov 05, 2025
7713938
Apr 15, 2027
8119648
Aug 12, 2023
8178541
Aug 12, 2023
8178541
Aug 12, 2023
8551957
Oct 19, 2029
8673927
May 04, 2027
8846695
Jun 04, 2030
8883805
Nov 26, 2025
9173859
May 04, 2027
PATENT NO

PATENT
CODES

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NC
NCE
NCE

Jan 30, 2018

May 02, 2016

Aug 01, 2019

NC
NCE
NCE

Jan 30, 2018

May 02, 2016

Aug 01, 2019

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 001 7579449
Nov 05, 2025
DS
7713938
Apr 15, 2027
DS DP

NCE
NP

Aug 01, 2019

Aug 26, 2018

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 002 7579449
Nov 05, 2025
DS
7713938
Apr 15, 2027
DS DP

NCE
NP

Aug 01, 2019

Aug 26, 2018

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 003 7579449
Nov 05, 2025
DS
7713938
Apr 15, 2027
DS DP

NCE
NP

Aug 01, 2019

Aug 26, 2018

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 004 7579449
Nov 05, 2025
DS
7713938
Apr 15, 2027
DS DP

NCE
NP

Aug 01, 2019

Aug 26, 2018

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI

N 206073 002 6303661
Apr 24,
6890898
Feb 02,
7078381
Feb 02,
7407955
Aug 12,
7459428
Feb 02,
7579449
Nov 05,
7713938
Apr 15,
8119648
Aug 12,
8178541
Aug 12,
8178541
Aug 12,
8551957
Oct 19,
8673927
May 04,
8846695
Jun 04,
8883805
Nov 26,
9173859
May 04,

2017
2019
2019
2023
2019
2025
2027
2023
2023
2023
2029
2024
2030
2025
2027

U-1651
U-1652
U-1651

PATENT
DELIST
REQUESTED

DS DP

U-1651

DS

DS DP

DP
DP
DP
DP

U-1651

U-1653

U-1654

U-1651

U-1652

U-1652

DP

DP U-1772

U-1651
U-1652
U-1651
DS DP

U-1651

DS

DS DP

DP
DP
DP
DP

U-1651

U-1653

U-1654

U-1651

U-1652

U-1652

DP

DP U-1772

EMTRICITABINE - EMTRIVA

N 021500 001 5814639
5914331
6642245
6642245
6703396

Sep
Jul
Nov
Nov
Mar

29,
02,
04,
04,
09,

2015
2017
2020
2020
2021

DS DP

DS

EMTRICITABINE - EMTRIVA

N 021896 001 5814639
5914331
6642245
6703396

Sep
Jul
Nov
Mar

29,
02,
04,
09,

2015
2017
2020
2021

DS DP

DS

U-257

U-541

DS DP

U-257

DS DP

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR

N 202123 001 5814639
Sep 29, 2015
DS
5914331
Jul 02, 2017
DS
5922695
Jul 25, 2017
DS
5935946
Jul 25, 2017
DS
5977089
Jul 25, 2017
DS
6043230
Jul 25, 2017

DISOPROXIL FUMARATE - COMPLERA

DP
NCE
NPP
U-257

DP U-257

DP U-257

U-257

May 20, 2016

Dec 13, 2016

ADA 67 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR
N 202123 001 6642245
Nov 04, 2020
6703396
Mar 09, 2021
DS
6838464
Feb 26, 2021
DS
7067522
Dec 20, 2019
DS
7125879
Aug 09, 2022
DS
8080551
Apr 11, 2023
DS
8101629
Aug 09, 2022
8592397
Jan 13, 2024
8716264
Jan 13, 2024
8841310
Dec 09, 2025
PATENT NO

PATENT
DELIST
PATENT
EXCLUSIVITY
REQUESTED
CODES
CODE(S)
DISOPROXIL FUMARATE - COMPLERA

U-257

DP

DP

DP

DP U-257

DP

DP

DP U-257

DP U-257

DP U-257

EXCLUSIVITY

EXPIRATION

DATE

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - TRUVADA

N 021752 001 5814639
Sep 29, 2015
DS DP

5914331
Jul 02, 2017
DS DP U-248

5922695
Jul 25, 2017
DS
U-248

5922695
Jul 25, 2017
DS
U-541

5922695
Jul 25, 2017
DS
U-1170

5922695
Jul 25, 2017
DS
U-1259

5935946
Jul 25, 2017
DS DP U-248

5935946
Jul 25, 2017
DS DP U-541

5935946
Jul 25, 2017
DS DP U-1170

5935946
Jul 25, 2017
DS DP U-1259

5977089
Jul 25, 2017
DS DP U-248

5977089
Jul 25, 2017
DS DP U-541

5977089
Jul 25, 2017
DS DP U-1170

5977089
Jul 25, 2017
DS DP U-1259

6043230
Jul 25, 2017
DP U-248

6043230
Jul 25, 2017
DP U-541

6043230
Jul 25, 2017
DP U-1170

6043230
Jul 25, 2017
DP U-1259

6642245
Nov 04, 2020
U-248

6642245
Nov 04, 2020
U-541

6642245
Nov 04, 2020
U-1170

6703396
Mar 09, 2021
DS DP

8592397
Jan 13, 2024
DP U-248

8592397
Jan 13, 2024
DP U-541

8592397
Jan 13, 2024
DP U-1170

8716264
Jan 13, 2024
DP U-257

ENALAPRIL MALEATE - EPANED KIT

N 204308 001 8568747
8778366
8778366

Nov 06, 2032

Nov 06, 2032
Nov 06, 2032

DP

ENTACAPONE - COMTAN

N 020796 001 6599530

Sep 14, 2018

DP U-219

ENTECAVIR - BARACLUDE

N 021797 001 5206244*PED

Aug 21, 2015

NPP
NPP
PED
PED

Oct
Mar
Apr
Sep

12,
20,
12,
20,

2015

2017

2016

2017

ENTECAVIR - BARACLUDE

N 021797 002 5206244*PED

Aug 21, 2015

NPP
NPP
PED
PED

Oct
Mar
Apr
Sep

12,
20,
12,
20,

2015

2017

2016

2017

ENTECAVIR - BARACLUDE

N 021798 001 5206244*PED

Aug 21, 2015

NPP
NPP
PED
PED

Oct
Mar
Apr
Sep

12,
20,
12,
20,

2015

2017

2016

2017

ENZALUTAMIDE - XTANDI

N 203415 001 7709517
8183274
8183274

Aug 13, 2027

May 15, 2026
May 15, 2026

I-693
NCE

Sep 10, 2017

Aug 31, 2017

U-3

U-185

DS DP
U-1281
U-1588

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 68 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ENZALUTAMIDE - XTANDI
N 203415 001 9126941

May 15, 2026

EPINEPHRINE - EPIPEN
N 019430 001 7449012
7794432
8048035
8870827

Sep
Sep
Sep
Sep

11,
11,
11,
11,

2025
2025
2025
2025

DP
DP
DP
DP

EPINEPHRINE - EPIPEN JR.

N 019430 002 7449012
7794432
8048035
8870827

Sep
Sep
Sep
Sep

11,
11,
11,
11,

2025
2025
2025
2025

DP
DP
DP
DP

EPINEPHRINE - TWINJECT 0.3

N 020800 001 7297136
7621891

Jan 18, 2025

Feb 04, 2025

DP
DP

EPINEPHRINE - TWINJECT 0.15

N 020800 002 7297136
7621891

Jan 18, 2025

Feb 04, 2025

DP
DP

EPINEPHRINE - AUVI-Q
N 201739 001 7731686
7731690
7749194
7918823
7947017
8016788
8021344
8206360
8226610
8231573
8313466
8361029
8425462
8608698
8920377
8926594
9056170
9149579

Jun
Jan
Oct
Nov
Mar
Mar
Nov
Feb
Apr
Nov
Nov
Nov
Nov
Nov
Nov
Mar
Nov
Jul

01,
15,
30,
23,
12,
21,
02,
27,
10,
25,
23,
23,
23,
23,
23,
31,
23,
19,

2026
2025
2028
2024
2028
2025
2029
2027
2029
2028
2024
2024
2024
2024
2024
2026
2024
2025

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

EPINEPHRINE - AUVI-Q
N 201739 002 7731686
7731690
7749194
7918823
7947017
8016788
8021344
8206360
8226610
8231573
8313466
8361029
8425462
8608698
8920377
8926594
9056170
9149579

Jun
Jan
Oct
Nov
Mar
Mar
Nov
Feb
Apr
Nov
Nov
Nov
Nov
Nov
Nov
Mar
Nov
Jul

01,
15,
30,
23,
12,
21,
02,
27,
10,
25,
23,
23,
23,
23,
23,
31,
23,
19,

2026
2025
2028
2024
2028
2025
2029
2027
2029
2028
2024
2024
2024
2024
2024
2026
2024
2025

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

EPINEPHRINE - ADRENALIN
N 204640 001 9119876

Mar 13, 2035

DP

PATENT
DELIST
REQUESTED

U-1588

U-1758

U-1758

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - LIDOSITE TOPICAL SYSTEM KIT

N 021504 001 6629968
Jun 30, 2020
DS DP

6635045
Jun 29, 2021
DS DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 69 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

EPLERENONE - INSPRA
N 021437 001 6410054
6410054
6410524
6495165
6495165
6534093
6534093
6558707
6747020
7157101

Dec
Dec
Nov
Dec
Dec
Dec
Dec
Dec
Nov
Dec

08,
08,
05,
08,
08,
08,
08,
08,
05,
08,

2019
2019
2019
2019
2019
2019
2019
2019
2019
2019

U-3
U-537
U-467
U-3
U-537
U-3
U-537
DP U-537
U-587
DP U-664

EPLERENONE - INSPRA
N 021437 002 6410054
6410054
6410524
6495165
6495165
6534093
6534093
6558707
6747020
7157101

Dec
Dec
Nov
Dec
Dec
Dec
Dec
Dec
Nov
Dec

08,
08,
05,
08,
08,
08,
08,
08,
05,
08,

2019
2019
2019
2019
2019
2019
2019
2019
2019
2019

U-3
U-537
U-467
U-3
U-537
U-3
U-537
DP U-537
U-587
DP U-664

EPLERENONE - INSPRA
N 021437 003 6410054
6410054
6410524
6495165
6495165
6534093
6534093
6558707
6747020
7157101

Dec
Dec
Nov
Dec
Dec
Dec
Dec
Dec
Nov
Dec

08,
08,
05,
08,
08,
08,
08,
08,
05,
08,

2019
2019
2019
2019
2019
2019
2019
2019
2019
2019

U-3
U-537
U-467
U-3
U-537
U-3
U-537
DP U-537
U-587
DP U-664

EPOPROSTENOL SODIUM - VELETRI

N 022260 001 8318802
8598227

Mar 15, 2027

Feb 02, 2027

DP

EPOPROSTENOL SODIUM - VELETRI

N 022260 002 8318802
8598227

Mar 15, 2027

Feb 02, 2027

DP

EPTIFIBATIDE - INTEGRILIN
N 020718 001 5807825

Sep 15, 2015

U-244

EPTIFIBATIDE - INTEGRILIN
N 020718 002 5807825

Sep 15, 2015

U-244

ERIBULIN MESYLATE - HALAVEN

N 201532 001 6214865
6469182
7470720
8097648

Jul
Jun
Jun
Jan

20,
16,
16,
22,

2023
2019
2019
2021

DS

ERLOTINIB HYDROCHLORIDE - TARCEVA

N 021743 001 5747498
Nov
5747498*PED
May
6900221
Nov
6900221
Nov
6900221
Nov
6900221
Nov
6900221*PED
May
7087613
Nov
7087613
Nov
7087613
Nov
7087613*PED
May
RE41065
Nov
RE41065*PED
May

08,
08,
09,
09,
09,
09,
09,
09,
09,
09,
09,
08,
08,

2018
2019
2020
2020
2020
2020
2021
2020
2020
2020
2021
2018
2019

DS DP U-659

PATENT NO

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Nov 15, 2015

I-671
PED

May 14, 2016

Nov 14, 2016

U-1096
DP
U-1096

DS
DS
DS
DS

DP
DP
DP
DP

U-659
U-875
U-1046
U-1403
U-659
U-1045
U-1403

DS DP

ADA 70 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ERLOTINIB HYDROCHLORIDE - TARCEVA

N 021743 001 5747498
Nov
5747498*PED
May
6900221
Nov
6900221
Nov
6900221
Nov
6900221
Nov
6900221*PED
May
7087613
Nov
7087613
Nov
7087613
Nov
7087613*PED
May
RE41065
Nov
RE41065*PED
May

08,
08,
09,
09,
09,
09,
09,
09,
09,
09,
09,
08,
08,

2018
2019
2020
2020
2020
2020
2021
2020
2020
2020
2021
2018
2019

DS DP U-659

ERLOTINIB HYDROCHLORIDE - TARCEVA

N 021743 002 5747498
Nov
5747498*PED
May
6900221
Nov
6900221
Nov
6900221
Nov
6900221
Nov
6900221*PED
May
7087613
Nov
7087613
Nov
7087613
Nov
7087613*PED
May
RE41065
Nov
RE41065*PED
May

08,
08,
09,
09,
09,
09,
09,
09,
09,
09,
09,
08,
08,

2018
2019
2020
2020
2020
2020
2021
2020
2020
2020
2021
2018
2019

DS DP U-659

ERLOTINIB HYDROCHLORIDE - TARCEVA

N 021743 003 5747498
Nov
5747498*PED
May
6900221
Nov
6900221
Nov
6900221
Nov
6900221
Nov
6900221*PED
May
7087613
Nov
7087613
Nov
7087613
Nov
7087613*PED
May
RE41065
Nov
RE41065*PED
May

08,
08,
09,
09,
09,
09,
09,
09,
09,
09,
09,
08,
08,

2018
2019
2020
2020
2020
2020
2021
2020
2020
2020
2021
2018
2019

DS DP U-659

ERTAPENEM SODIUM - INVANZ

N 021337 001 5478820
5952323

Nov 21, 2015

May 15, 2017

DS DP U-160
DP

ESCITALOPRAM OXALATE - LEXAPRO

N 021323 001 6916941
7420069

Aug 12, 2022

Aug 12, 2022

DS DP
DP

ESCITALOPRAM OXALATE - LEXAPRO

N 021323 002 6916941
7420069

Aug 12, 2022

Aug 12, 2022

DS DP
DP

ESCITALOPRAM OXALATE - LEXAPRO

N 021323 003 6916941
7420069

Aug 12, 2022

Aug 12, 2022

DS DP
DP

DS
DS
DS
DS

DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-671
PED

May 14, 2016

Nov 14, 2016

I-671
PED

May 14, 2016

Nov 14, 2016

I-671
PED

May 14, 2016

Nov 14, 2016

U-659
U-875
U-1046
U-1403
U-659
U-1045
U-1403

DS DP

DS
DS
DS
DS

DP
DP
DP
DP

U-659
U-875
U-1046
U-1403
U-659
U-1045
U-1403

DS DP

DS
DS
DS
DS

DP
DP
DP
DP

U-659
U-875
U-1046
U-1403
U-659
U-1045
U-1403

DS DP

ESLICARBAZEPINE ACETATE - APTIOM

N 022416 001 5753646
Jun 27, 2016
5753646
Jun 27, 2016
8372431
Apr 17, 2030

DS DP U-1451
DS DP U-1746
DP

D-150
I-715
NCE

Aug 27, 2018

Aug 27, 2018
Nov 08, 2018

ESLICARBAZEPINE ACETATE - APTIOM

N 022416 002 5753646
Jun 27, 2016
5753646
Jun 27, 2016
8372431
Apr 17, 2030

DS DP U-1451
DS DP U-1746
DP

D-150
I-715
NCE

Aug 27, 2018

Aug 27, 2018
Nov 08, 2018

ADA 71 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ESLICARBAZEPINE ACETATE - APTIOM

N 022416 002 5753646
Jun 27, 2016
5753646
Jun 27, 2016
8372431
Apr 17, 2030

DS DP U-1451
DS DP U-1746
DP

D-150
I-715
NCE

Aug 27, 2018

Aug 27, 2018

Nov 08, 2018

ESLICARBAZEPINE ACETATE - APTIOM

N 022416 003 5753646
Jun 27, 2016
5753646
Jun 27, 2016
8372431
Apr 17, 2030

DS DP U-1451
DS DP U-1746
DP

D-150
I-715
NCE

Aug 27, 2018

Aug 27, 2018

Nov 08, 2018

ESLICARBAZEPINE ACETATE - APTIOM

N 022416 004 5753646
Jun 27, 2016
5753646
Jun 27, 2016
8372431
Apr 17, 2030

DS DP U-1451
DS DP U-1746
DP

D-150
I-715
NCE

Aug 27, 2018

Aug 27, 2018

Nov 08, 2018

ESMOLOL HYDROCHLORIDE - BREVIBLOC IN PLASTIC CONTAINER

N 019386 004 6310094
Jan 12, 2021

6528540
Jan 12, 2021

ESMOLOL HYDROCHLORIDE - BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

N 019386 005 6310094
Jan 12, 2021

6528540
Jan 12, 2021

ESMOLOL HYDROCHLORIDE - BREVIBLOC

N 019386 006 6310094
Jan 12, 2021

6528540
Jan 12, 2021

ESMOLOL HYDROCHLORIDE - BREVIBLOC

N 019386 007 6310094
Jan 12, 2021

6528540
Jan 12, 2021

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N 021153 001 5900424
5900424
5900424
6147103
6166213
6191148
6369085
6369085
6428810
6428810
6428810
7411070
8466175
8466175*PED

May
May
May
Oct
Oct
Oct
May
May
Nov
Nov
Nov
May
May
Nov

04,
04,
04,
09,
09,
09,
25,
25,
03,
03,
03,
25,
25,
25,

2016
2016
2016
2018

2018

2018

2018
2018
2019
2019
2019
2018
2018
2018

DS
DS
DS

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N 021153 002 5900424
5900424
5900424
6147103
6166213
6191148
6369085
6369085
6428810
6428810
6428810
7411070
8466175
8466175*PED

May
May
May
Oct
Oct
Oct
May
May
Nov
Nov
Nov
May
May
Nov

04,
04,
04,
09,
09,
09,
25,
25,
03,
03,
03,
25,
25,
25,

2016
2016
2016
2018

2018

2018

2018
2018
2019
2019
2019
2018
2018
2018

DS
DS
DS

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N 021957 001 5900424
May 04, 2016
5900424
May 04, 2016
5900424
May 04, 2016
6369085
May 25, 2018
6369085
May 25, 2018
6369085
May 25, 2018

U-373

U-729

U-770

DS DP U-729

DS DP U-770

DP U-469

DP U-729

DP U-770

DS

U-1417

U-373

U-729

U-770

DS DP U-729

DS DP U-770

DP U-469

DP U-729

DP U-770

DS

U-1417

DS
U-729

DS
U-773

DS
U-1207

DS DP U-729

DS DP U-773

DS DP U-1207

ADA 72 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N 021957 001 6428810
6428810
6428810
7411070
8466175
8466175*PED

Nov
Nov
Nov
May
May
Nov

03,
03,
03,
25,
25,
25,

2019
2019
2019
2018
2018
2018

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N 021957 002 5900424
5900424
5900424
6369085
6369085
6369085
6428810
6428810
6428810
7411070
8466175
8466175*PED

May
May
May
May
May
May
Nov
Nov
Nov
May
May
Nov

04,
04,
04,
25,
25,
25,
03,
03,
03,
25,
25,
25,

2016
2016
2016
2018
2018
2018
2019
2019
2019
2018
2018
2018

DS
U-729
DS
U-773
DS
U-1207
DS DP U-729
DS DP U-773
DS DP U-1207
DP U-729
DP U-773
DP U-1207
DS
U-1417

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N 021957 003 5900424
6369085
6428810
7411070

May
May
Nov
May

04,
25,
03,
25,

2016
2018
2019
2018

DS
U-1207
DS DP U-1207
DP U-1207
DS

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N 021957 004 5900424
6369085
6428810
7411070

May
May
Nov
May

04,
25,
03,
25,

2016
2018
2019
2018

DS
U-1207
DS DP U-1207
DP U-1207
DS

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N 022101 001 5900424
6369085
6428810
7411070

May
May
Nov
May

04,
25,
03,
25,

2016
2018
2019
2018

DS
U-858
DS DP U-858
DP U-858
DS

ESOMEPRAZOLE MAGNESIUM - NEXIUM 24HR

N 204655 001 5714504*PED
Aug 03, 2015
5900424
May 04, 2016
5900424*PED
Nov 04, 2016
6369085
May 25, 2018
6369085*PED
Nov 25, 2018
6428810
Nov 03, 2019
6428810*PED
May 03, 2020
7411070
May 25, 2018
7411070*PED
Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM 24HR
N 207920 01
5900424
May 04, 2016
5900424*PED
Nov 04, 2016
6369085
May 25, 2018
6369085*PED
Nov 25, 2018
6428810
Nov 03, 2019
6428810*PED
May 03, 2020
7411070
May 18, 2018
7411070*PED
Nov 18, 2018
ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO
N 022511 001 5900424
May 04, 2016
6369085
May 25, 2018
6926907
Feb 28, 2023
7411070
May 25, 2018
7745466
Oct 13, 2018
8557285
May 31, 2022
8852636
May 31, 2022
8858996
May 31, 2022

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-729
DP U-773
DP U-1207
DS
U-1417

RTO
DS

U-1509

DS DP U-1509
DP U-1509
DS

DS

U-1783

DS DP U-1784
DP U-1785
DS

DS
DS DP
DP
DS
DP
DP
DP
DP

U-1053
U-1053
U-1052
U-1053
U-1053
U-1052
U-1052

Mar 28, 2017

ADA 73 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO
N 022511 001 8945621
Oct 17, 2031
9161920
May 31, 2022
9198888
May 31, 2022
APPL/PROD
NO

PATENT NO

ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO

N 022511 002 5900424
May 04, 2016
6369085
May 25, 2018
6926907
Feb 28, 2023
7411070
May 25, 2018
7745466
Oct 13, 2018
8557285
May 31, 2022
8852636
May 31, 2022
8858996
May 31, 2022
8945621
Oct 17, 2031
9161920
May 31, 2022
9198888
May 31, 2022

PATENT
CODES

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1661
U-1760
U-1781

DS
DS DP
DP
DS
DP
DP
DP
DP

U-1053
U-1053
U-1052
U-1053
U-1053
U-1052
U-1052
U-1661
U-1760
U-1781

ESOMEPRAZOLE SODIUM - NEXIUM IV

N 021689 001

ESOMEPRAZOLE SODIUM - NEXIUM IV

N 021689 002

ESTRADIOL - VAGIFEM
N 020908 002 5860946
7018992

Jul 01, 2017

Sep 17, 2022

DP

ESTRADIOL - MENOSTAR
N 021674 001 5891868
6692763

Nov 21, 2017

Nov 21, 2017

DP U-594
DP U-594

ESTRADIOL - ELESTRIN
N 021813 001 7198801
7470433

Jun 25, 2022

Aug 03, 2021

DP
DP

ESTRADIOL - EVAMIST
N 022014 001 6299900
6299900
6818226
6818226
6923983
6923983
6978945

Feb
Feb
Feb
Feb
Feb
Feb
Jul

2017
2017
2017
2017
2017
2017
2022

DP
DP
DP
DP
DP
DP
DP

ESTRADIOL - MINIVELLE
N 203752 001 6841716
8231906

Apr 27, 2020

Jul 04, 2030

DP
DS DP

ESTRADIOL - MINIVELLE
N 203752 002 6841716
8231906

Apr 27, 2020

Jul 04, 2030

DP
DS DP

ESTRADIOL - MINIVELLE
N 203752 003 6841716
8231906

Apr 27, 2020

Jul 04, 2030

DP
DS DP

ESTRADIOL - MINIVELLE
N 203752 004 6841716
8231906

Apr 27, 2020

Jul 04, 2030

DP
DS DP

ESTRADIOL - MINIVELLE
N 203752 005 6841716
8231906

Apr 27, 2020

Jul 04, 2030

DP
DS DP

ESTRADIOL ACETATE - FEMRING

N 021367 001 5855906

Dec 19, 2015

19,
19,
19,
19,
19,
19,
31,

PATENT
DELIST
REQUESTED

U-1023

U-888
U-889
U-888
U-889
U-888
U-889

U-508

D-138
I-679

Mar 04, 2017

Mar 04, 2017

D-138
I-679

Mar 04, 2017

Mar 04, 2017

ADA 74 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT

EXPIRATION

DATE

PATENT
CODES

ESTRADIOL ACETATE - FEMRING

N 021367 002 5855906

Dec 19, 2015

ESTRADIOL ACETATE - FEMTRACE

N 021633 001 6962908
7572779
7799771

Dec 21, 2021

Oct 02, 2025

Dec 21, 2021

DP

ESTRADIOL ACETATE - FEMTRACE

N 021633 002 6962908
7572779
7799771

Dec 21, 2021

Oct 02, 2025

Dec 21, 2021

DP

ESTRADIOL ACETATE - FEMTRACE

N 021633 003 6962908
7572779
7799771

Dec 21, 2021

Oct 02, 2025

Dec 21, 2021

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-508

U-904
DP

U-904
DP

U-904
DP

ESTRADIOL; ESTRADIOL; NORGESTIMATE - PREFEST

N 021040 001 6747019
Mar 20, 2020

7320970
Mar 30, 2020

U-311
DP U-844

ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN

N 020992 001 5908638
Jul 26, 2015

DP

ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN

N 020992 002 5908638
Jul 26, 2015

ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN

N 020992 003 5908638
Jul 26, 2015

ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN

N 020992 004 5908638
Jul 26, 2015

ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN

N 020992 005 5908638
Jul 26, 2015

ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA

N 021443 001 6660726
Mar 08, 2021

6660726
Mar 08, 2021

6855703
Feb 12, 2021

6855703
Feb 12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-904
U-905
U-904
U-905

ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA

N 021443 002 6660726
Mar 08, 2021

6660726
Mar 08, 2021

6855703
Feb 12, 2021

6855703
Feb 12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-904
U-905
U-904
U-905

ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA

N 021443 003 6660726
Mar 08, 2021

6660726
Mar 08, 2021

6855703
Feb 12, 2021

6855703
Feb 12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-904
U-905
U-904
U-905

ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA

N 021443 004 6660726
Mar 08, 2021

6660726
Mar 08, 2021

6855703
Feb 12, 2021

6855703
Feb 12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-904
U-905
U-904
U-905

ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA

N 021443 005 6660726
Mar 08, 2021

6660726
Mar 08, 2021

6855703
Feb 12, 2021

6855703
Feb 12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-904
U-905
U-904
U-905

ESZOPICLONE - LUNESTA

N 021476 001

M-61
PED

Oct 10, 2015

Apr 10, 2016

ADA 75 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

ESZOPICLONE - LUNESTA

N 021476 002

ESZOPICLONE - LUNESTA

N 021476 003

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

M-61
PED

Oct 10, 2015

Apr 10, 2016

M-61
PED

Oct 10, 2015

Apr 10, 2016

ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; NORGESTIMATE; NORGESTIMATE; NORGESTIMATE - ORTHO

TRI-CYCLEN LO

N 021241 001 6214815
Jun 09, 2019
U-112

ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONIQUE

N 021840 001 7320969
Jan 30, 2024
U-828

7615545
Jun 15, 2023
U-1

7855190
Dec 05, 2028
U-1

7858605
Jun 23, 2023
DP

ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; LEVONORGESTREL - LOSEASONIQUE

N 022262 001 7615545
Jun 15, 2023
U-1

7855190
Dec 05, 2028
U-1

7858605
Jun 23, 2023
DP

ETHINYL ESTRADIOL; ETONOGESTREL - NUVARING

N 021187 001 5989581
Apr 08, 2018

ETHINYL ESTRADIOL; LEVONORGESTREL - PREVEN EMERGENCY CONTRACEPTIVE KIT

N 020946 001 6156742
Dec 05, 2020
U-374

ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONALE

N 021544 001 5898032
Jun 23, 2017
RE39861
Jun 23, 2017

U-1

U-828

ETHINYL ESTRADIOL; LEVONORGESTREL - LYBREL

N 021864 001 6500814
Sep 03, 2018

U-1

ETHINYL ESTRADIOL; LEVONORGESTREL - QUARTETTE

N 204061 001 8415332
Mar 11, 2029
8450299
Oct 07, 2025

DP

NP

Mar 28, 2016

U-1

ETHINYL ESTRADIOL; NORELGESTROMIN - ORTHO EVRA

N 021180 001 5876746
Nov 20, 2015

DP U-514

ETHINYL ESTRADIOL; NORETHINDRONE - FEMCON FE

N 021490 001 6667050
Apr 06, 2019

DP U-1

ETHINYL ESTRADIOL; NORETHINDRONE - NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

N 022573 001 6667050
Apr 06, 2019
DP U-828

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LO LOESTRIN FE

N 022501 001 7704984
Feb 02, 2029
U-1090

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - MINASTRIN 24 FE

N 203667 001 6667050
Apr 06, 2019
DP U-1

NDF

May 08, 2016

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

N 204426 001 6652880
Mar 29, 2020
DP

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LO MINASTRIN FE

N 204654 001 6667050
Apr 06, 2019
DP U-1

7704984
Feb 02, 2029
U-1

ETHIODIZED OIL - LIPIODOL

N 009190 001
ETONOGESTREL - NEXPLANON

N 021529 002 8722037
8888745

ODE

Sep 28, 2027

Aug 28, 2026

DP

DP

Apr 04, 2021

ADA 76 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ETRAVIRINE - INTELENCE
N 022187 001 6878717
6878717
6878717
7037917
7037917
7037917
7887845
8003789

Nov
Nov
Nov
Dec
Dec
Dec
Mar
Nov

05,
05,
05,
13,
13,
13,
25,
01,

2019
2019
2019
2020
2020
2020
2019
2019

U-256
U-1016
U-1237
DS DP U-256
DS DP U-1016
DS DP U-1237
DP
DS DP

ETRAVIRINE - INTELENCE
N 022187 002 6878717
6878717
6878717
7037917
7037917
7037917
7887845
8003789

Nov
Nov
Nov
Dec
Dec
Dec
Mar
Nov

05,
05,
05,
13,
13,
13,
25,
01,

2019
2019
2019
2020
2020
2020
2019
2019

U-256
U-1016
U-1237
DS DP U-256
DS DP U-1016
DS DP U-1237
DP
DS DP

ETRAVIRINE - INTELENCE
N 022187 003 6878717
6878717
6878717
7037917
7887845
8003789

Nov
Nov
Nov
Dec
Mar
Nov

05,
05,
05,
13,
25,
01,

2019
2019
2019
2020
2019
2019

U-256
U-1016
U-1237
DS DP U-1237
DP
DS DP

EVEROLIMUS - ZORTRESS
N 021560 001 5665772
5665772
5665772*PED
6004973
6004973
6004973*PED
6239124
6455518
6455518
6455518*PED

Sep
Sep
Mar
Jul
Jul
Jan
Aug
Jul
Jul
Jan

09,
09,
09,
12,
12,
12,
11,
29,
29,
29,

2019
2019
2020
2016
2016
2017
2017
2017
2017
2018

DS DP U-1049
DS DP U-1365

EVEROLIMUS - ZORTRESS
N 021560 002 5665772
5665772
5665772*PED
6004973
6004973
6004973*PED
6239124
6455518
6455518
6455518*PED

Sep
Sep
Mar
Jul
Jul
Jan
Aug
Jul
Jul
Jan

09,
09,
09,
12,
12,
12,
11,
29,
29,
29,

2019
2019
2020
2016
2016
2017
2017
2017
2017
2018

DS DP U-1049
DS DP U-1365

EVEROLIMUS - ZORTRESS
N 021560 003 5665772
5665772
5665772*PED
6004973
6004973
6004973*PED
6239124
6455518
6455518
6455518*PED

Sep
Sep
Mar
Jul
Jul
Jan
Aug
Jul
Jul
Jan

09,
09,
09,
12,
12,
12,
11,
29,
29,
29,

2019
2019
2020
2016
2016
2017
2017
2017
2017
2018

DS DP U-1049
DS DP U-1365

EVEROLIMUS - AFINITOR
N 022334 001 5665772
6004973
7297703
7741338
8410131

Sep
Jul
Dec
Dec
Nov

09,
12,
06,
06,
01,

2019
2016
2019
2019
2025

DS DP
DP
DP
DP
DS DP U-1368

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-668

Feb 15, 2016

I-668

Feb 15, 2016

I-668

Feb 15, 2016

I-655
ODE
ODE
ODE
PED

Jul
Oct
May
Apr
Oct

DP U-1049
DP U-1365
U-1049
U-1049
U-1365

DP U-1049
DP U-1365
U-1049
U-1049
U-1365

DP U-1049
DP U-1365
U-1049
U-1049
U-1365

20,
29,
05,
26,
26,

2015
2017
2018
2019
2015

ADA 77 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

EVEROLIMUS - AFINITOR

N 022334 001 8410131*PED
8436010
8436010*PED
8778962
8778962*PED
9006224

May
Feb
Aug
Feb
Aug
Jul

01,
22,
22,
18,
18,
01,

2026
2022
2022
2022
2022

2028

EVEROLIMUS - AFINITOR

N 022334 002 5665772
6004973
7297703
7741338
8410131
8410131*PED
8436010
8436010*PED
8778962
8778962*PED
9006224

Sep
Jul
Dec
Dec
Nov
May
Feb
Aug
Feb
Aug
Jul

09,
12,
06,
06,
01,
01,
22,
22,
18,
18,
01,

2019
2016
2019
2019
2025
2026
2022
2022
2022
2022

2028

DS DP
DP
DP
DP
DS DP U-1368

EVEROLIMUS - AFINITOR

N 022334 003 5665772
6004973
7297703
7741338
8410131
8410131*PED
8436010
8436010*PED
8778962
8778962*PED
9006224

Sep
Jul
Dec
Dec
Nov
May
Feb
Aug
Feb
Aug
Jul

09,
12,
06,
06,
01,
01,
22,
22,
18,
18,
01,

2019
2016
2019
2019
2025
2026
2022
2022
2022
2022

2028

DS DP
DP
DP
DP
DS DP U-1368

EVEROLIMUS - AFINITOR

N 022334 004 5665772
6004973
7297703
7741338
8410131
8410131*PED
8436010
8436010*PED
8778962
8778962*PED
9006224

Sep
Jul
Dec
Dec
Nov
May
Feb
Aug
Feb
Aug
Jul

09,
12,
06,
06,
01,
01,
22,
22,
18,
18,
01,

2019
2016
2019
2019
2025
2026
2022
2022
2022
2022

2028

DS DP
DP
DP
DP
DS DP U-1368

EVEROLIMUS - AFINITOR DISPERZ

N 203985 001 5665772
6004973
7297703
8617598
8617598*PED
8778962
8778962*PED

Sep
Jul
Dec
Sep
Mar
Feb
Aug

09,
12,
06,
27,
27,
18,
18,

2019
2016
2019
2022
2023

2022
2022

DS DP
DP
DP

DP

EVEROLIMUS - AFINITOR DISPERZ

N 203985 002 5665772
6004973
7297703
8617598
8617598*PED
8778962
8778962*PED

Sep
Jul
Dec
Sep
Mar
Feb
Aug

09,
12,
06,
27,
27,
18,
18,

2019
2016
2019
2022
2023

2022
2022

DS DP
DP
DP

DP

EVEROLIMUS - AFINITOR DISPERZ

N 203985 003 5665772
6004973
7297703
8617598

Sep
Jul
Dec
Sep

09,
12,
06,
27,

2019
2016
2019
2022

DS DP
DP
DP
DP

DS DP U-1396

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PED
PED
PED

Apr 29, 2018

Nov 05, 2018

Oct 26, 2019

I-655
ODE
ODE
ODE
PED
PED
PED
PED

Jul
Oct
May
Apr
Oct
Apr
Nov
Oct

20,
29,
05,
26,
26,
29,
05,
26,

2015

2017

2018

2019

2015

2018

2018

2019

I-655
ODE
ODE
ODE
PED
PED
PED
PED

Jul
Oct
May
Apr
Oct
Apr
Nov
Oct

20,
29,
05,
26,
26,
29,
05,
26,

2015

2017

2018

2019

2015

2018

2018

2019

I-655
ODE
ODE
ODE
PED
PED
PED
PED

Jul
Oct
May
Apr
Oct
Apr
Nov
Oct

20,
29,
05,
26,
26,
29,
05,
26,

2015

2017

2018

2019

2015

2018

2018

2019

ODE
PED

Oct 29, 2017

Apr 29, 2018

ODE
PED

Oct 29, 2017

Apr 29, 2018

ODE
PED

Oct 29, 2017

Apr 29, 2018

U-1541

U-1681

DS DP U-1396
U-1541

U-1681

DS DP U-1396
U-1541

U-1681

DS DP U-1396
U-1541

U-1681

U-1541

U-1541

ADA 78 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

EVEROLIMUS - AFINITOR DISPERZ

N 203985 003 8617598*PED
8778962
8778962*PED

Mar 27, 2023

Feb 18, 2022
Aug 18, 2022

EXENATIDE SYNTHETIC - BYETTA

N 021773 001 5424286
5424286
6858576
6858576
6872700
6902744
6956026
6956026
6956026
7297761
7521423
7741269
7741269
7741269

Dec
Dec
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Oct
Oct
Jan
Jan
Jan

01,
01,
06,
06,
14,
14,
07,
07,
07,
15,
15,
07,
07,
07,

2016
2016
2017
2017
2020
2020
2018
2018
2018
2017
2017
2018
2018
2018

EXENATIDE SYNTHETIC - BYETTA

N 021773 002 5424286
5424286
6858576
6858576
6872700
6902744
6956026
6956026
6956026
7297761
7521423
7741269
7741269
7741269

Dec
Dec
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Oct
Oct
Jan
Jan
Jan

01,
01,
06,
06,
14,
14,
07,
07,
07,
15,
15,
07,
07,
07,

2016
2016
2017
2017
2020
2020
2018
2018
2018
2017
2017
2018
2018
2018

EXENATIDE SYNTHETIC - BYDUREON

N 022200 001 5424286
6479065
6495164
6667061
6824822
6858576
6872700
6956026
7223440
7456254
7563871
7612176
7741269
8216180
8329648
8431685
8439864
8461105
8906851

Dec
Aug
May
May
Oct
Jan
Jan
Jan
Aug
Jun
Apr
Apr
Jan
Jan
Aug
Apr
Mar
Apr
Aug

01,
10,
25,
25,
09,
06,
14,
07,
31,
30,
15,
13,
07,
12,
18,
13,
25,
13,
18,

2016
2020
2020
2020
2022
2017
2020
2018
2021
2025
2024
2025
2018
2028
2026
2025
2028
2025
2026

EZETIMIBE - ZETIA
N 021445 001 7030106
7612058
7612058
7612058*PED
RE37721
RE42461
RE42461

Jan
Oct
Oct
Apr
Oct
Oct
Oct

25,
30,
30,
30,
25,
25,
25,

2022
2025
2025
2026
2016
2016
2016

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1541

U-653
U-1108
U-656
U-1108
U-654

M-148

Nov 24, 2017

M-148

Nov 24, 2017

M-162

Sep 24, 2018

DP
U-687
U-1074
U-1623
DP
DP
U-653
U-1074
U-1108

U-653
U-1108
U-656
U-1108
U-654
DP
U-687
U-1074
U-1623
DP
DP
U-653
U-1074
U-1108

U-1108
DP
DP
DP
DP
U-656
U-654
U-687
DP
DP U-1223
DP
DP U-1223
U-1224
DP
U-1313
DP U-412
DP
DP U-412
U-1313

DP
U-1027
U-1173
DS DP U-473
DS DP U-473
DS DP U-1173

ADA 79 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

EZETIMIBE; SIMVASTATIN - VYTORIN

N 021687 001 RE37721
Oct 25, 2016
RE42461
Oct 25, 2016

DS DP U-473
DS DP U-473

EZETIMIBE; SIMVASTATIN - VYTORIN

N 021687 002 RE37721
Oct 25, 2016
RE42461
Oct 25, 2016

DS DP U-473
DS DP U-473

EZETIMIBE; SIMVASTATIN - VYTORIN

N 021687 003 RE37721
Oct 25, 2016
RE42461
Oct 25, 2016

DS DP U-473
DS DP U-473

EZETIMIBE; SIMVASTATIN - VYTORIN

N 021687 004 RE37721
Oct 25, 2016
RE42461
Oct 25, 2016

DS DP U-473
DS DP U-473

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

EZOGABINE - POTIGA
N 022345 001

NCE

Jun 10, 2016

EZOGABINE - POTIGA
N 022345 002

NCE

Jun 10, 2016

EZOGABINE - POTIGA
N 022345 003

NCE

Jun 10, 2016

EZOGABINE - POTIGA
N 022345 004

NCE

Jun 10, 2016

FAMCICLOVIR - FAMVIR
N 020363 001 5840763
5916893

Sep 01, 2015

Sep 01, 2015

U-96
U-96

FAMCICLOVIR - FAMVIR
N 020363 002 5840763
5916893

Sep 01, 2015

Sep 01, 2015

U-96
U-96

FAMCICLOVIR - FAMVIR
N 020363 003 5840763
5916893

Sep 01, 2015

Sep 01, 2015

U-96
U-96

FAMOTIDINE - PEPCID AC
N 020325 001 5854267

Dec 29, 2015

U-267

FAMOTIDINE - PEPCID AC
N 020801 001 5854267

Dec 29, 2015

U-267

FAMOTIDINE - PEPCID AC
N 020801 002 6814978

Aug 26, 2021

FAMOTIDINE - PEPCID AC
N 020902 001 5854267

Dec 29, 2015

FAMOTIDINE - FLUXID
N 021712 001 6024981
6221392

Apr 09, 2018

Apr 09, 2018

DP
DP

FAMOTIDINE - FLUXID
N 021712 002 6024981
6221392

Apr 09, 2018

Apr 09, 2018

DP
DP

FAMOTIDINE; IBUPROFEN - DUEXIS

N 022519 001 8067033
8067451
8309127
8318202
8449910
8501228

Jul
Jul
Jul
Jul
Jul
Jul

DP
DP U-1196
DP
DP
DP
U-1196

FEBUXOSTAT - ULORIC
N 021856 001 5614520
6225474

Mar 25, 2019

Jun 18, 2019

18,
18,
18,
18,
18,
18,

2026
2026
2026
2026
2026
2026

DP

U-368

DS DP U-954
DS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 80 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FEBUXOSTAT - ULORIC
N 021856 001 7361676
8372872
9107912

Mar 08, 2024

Sep 08, 2031
Sep 08, 2031

FEBUXOSTAT - ULORIC
N 021856 002 5614520
6225474
7361676
8372872
9107912

Mar
Jun
Mar
Sep
Sep

25,
18,
08,
08,
08,

2019
2019
2024
2031
2031

FENOFIBRATE - TRICOR
N 021203 001 6074670
6277405
6589552
6652881
7037529
7041319

Jan
Jan
Jan
Jan
Jan
Jan

09,
09,
09,
09,
09,
09,

2018
2018
2018
2018
2018
2018

DP
DP
DP

FENOFIBRATE - TRICOR
N 021203 003 6074670
6277405
6589552
6652881
7037529
7041319

Jan
Jan
Jan
Jan
Jan
Jan

09,
09,
09,
09,
09,
09,

2018
2018
2018
2018
2018
2018

DP
DP
DP

FENOFIBRATE - TRIGLIDE
N 021350 001 6696084

Sep 11, 2021

DS DP U-680

FENOFIBRATE - TRIGLIDE
N 021350 002 6696084

Sep 11, 2021

DS DP U-680

FENOFIBRATE - TRICOR
N 021656 001 6277405
6375986
6652881
7037529
7041319
7276249
7320802

Jan
Sep
Jan
Jan
Jan
Feb
Feb

09,
21,
09,
09,
09,
21,
21,

2018
2020
2018
2018
2018
2023
2023

DS

FENOFIBRATE - TRICOR
N 021656 002 6277405
6375986
6652881
7037529
7041319
7276249
7320802

Jan
Sep
Jan
Jan
Jan
Feb
Feb

09,
21,
09,
09,
09,
21,
21,

2018
2020
2018
2018
2018
2023
2023

DS

FENOFIBRATE - ANTARA (MICRONIZED)

N 021695 001 7101574
Aug 20, 2020
7863331
Aug 08, 2020
7863331
Aug 08, 2020
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 003 7101574
Aug 20, 2020
7863331
Aug 08, 2020
7863331
Aug 08, 2020

DP
U-1346
U-1346

DS DP U-954
DS
DP
U-1346
U-1346

DP U-615
DS
DP
DP
DP
U-847

DP U-615
DS
DP
DP
DP
U-847

DS DP
U-1106
U-1107

DS DP
U-1106
U-1107

FENOFIBRATE - ANTARA (MICRONIZED)

N 021695 004 8026281
Apr 22, 2025
8026281
Apr 22, 2025

U-1447
U-1448

FENOFIBRATE - ANTARA (MICRONIZED)

N 021695 005 8026281
Apr 22, 2025
8026281
Apr 22, 2025

U-1447
U-1448

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 81 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FENOFIBRATE - FENOGLIDE

N 022118 001 7658944
8124125
8481078
9173847

Dec
Oct
Oct
Oct

09,
01,
01,
01,

2024
2024
2024
2024

DP

DP U-1234

DP U-1416

DP

FENOFIBRATE - FENOGLIDE

N 022118 002 7658944
8124125
8481078
9173847

Dec
Oct
Oct
Oct

09,
01,
01,
01,

2024
2024
2024
2024

DP

DP U-1234

DP U-1416

DP

FENOFIBRIC ACID - FIBRICOR

N 022418 001 7569612
7741373
7741374
7741374
7915247
7915247
7915247

Aug
Aug
Aug
Aug
Aug
Aug
Aug

20,
20,
20,
20,
20,
20,
20,

2027
2027
2027
2027
2027
2027
2027

U-1000

U-1059

U-1060

U-1061

U-1000

U-1059

U-1061

FENOFIBRIC ACID - FIBRICOR

N 022418 002 7569612
7741373
7741374
7741374
7915247
7915247
7915247

Aug
Aug
Aug
Aug
Aug
Aug
Aug

20,
20,
20,
20,
20,
20,
20,

2027
2027
2027
2027
2027
2027
2027

U-1000

U-1059

U-1060

U-1061

U-1000

U-1059

U-1061

FENTANYL - SUBSYS

N 202788 001 8486972
8486973
8835459
8835460

Apr
Apr
Jan
Jan

27,
27,
25,
25,

2030
2030
2027
2027

DP

FENTANYL - SUBSYS

N 202788 002 8486972
8486973
8835460

Apr 27, 2030

Apr 27, 2030
Jan 25, 2027

DP

FENTANYL - SUBSYS

N 202788 003 8486972
8486973
8835459
8835460

Apr
Apr
Jan
Jan

27,
27,
25,
25,

2030
2030
2027
2027

DP

FENTANYL - SUBSYS

N 202788 004 8486972
8486973
8835459
8835460

Apr
Apr
Jan
Jan

27,
27,
25,
25,

2030
2030
2027
2027

DP

FENTANYL - SUBSYS

N 202788 005 8486972
8486973
8835460

Apr 27, 2030

Apr 27, 2030
Jan 25, 2027

DP

FENTANYL - SUBSYS

N 202788 006 8486972
8486973
8835459
8835460

Apr
Apr
Jan
Jan

27,
27,
25,
25,

2030
2030
2027
2027

DP

FENTANYL - SUBSYS

N 202788 007 8486972
8486973
8835459
8835460

Apr
Apr
Jan
Jan

27,
27,
25,
25,

2030
2030
2027
2027

DP

PATENT NO

U-55

DP

DP U-55

U-55

DP U-55

U-55

DP

DP U-55

U-55

DP

DP U-55

U-55

DP U-55

U-55

DP

DP U-55

U-55

DP

DP U-55

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 82 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FENTANYL CITRATE - FENTORA

N 021947 001 6200604
6974590
7862832
7862833
8092832
8728441
8753611
8765100

Mar
Mar
Jun
Jun
Dec
Mar
Mar
Mar

26,
26,
15,
15,
30,
26,
26,
26,

2019
2019
2028
2028
2024
2019
2019
2019

FENTANYL CITRATE - FENTORA

N 021947 002 6200604
6974590
7862832
7862833
8092832
8119158
8728441
8753611
8765100

Mar
Mar
Jun
Jun
Dec
Dec
Mar
Mar
Mar

26,
26,
15,
15,
30,
30,
26,
26,
26,

2019
2019
2028
2028
2024
2024
2019
2019
2019

FENTANYL CITRATE - FENTORA

N 021947 003 6200604
6974590
7862832
7862833
8092832
8119158
8728441
8753611
8765100

Mar
Mar
Jun
Jun
Dec
Dec
Mar
Mar
Mar

26,
26,
15,
15,
30,
30,
26,
26,
26,

2019
2019
2028
2028
2024
2024
2019
2019
2019

FENTANYL CITRATE - FENTORA

N 021947 004 6200604
6974590
7862832
7862833
8092832
8119158
8728441
8753611
8765100

Mar
Mar
Jun
Jun
Dec
Dec
Mar
Mar
Mar

26,
26,
15,
15,
30,
30,
26,
26,
26,

2019
2019
2028
2028
2024
2024
2019
2019
2019

FENTANYL CITRATE - FENTORA

N 021947 005 6200604
6974590
7862832
7862833
8092832
8119158
8728441
8753611
8765100

Mar
Mar
Jun
Jun
Dec
Dec
Mar
Mar
Mar

26,
26,
15,
15,
30,
30,
26,
26,
26,

2019
2019
2028
2028
2024
2024
2019
2019
2019

FENTANYL CITRATE - FENTORA

N 021947 006 6200604
6974590

Mar 26, 2019

Mar 26, 2019

FENTANYL CITRATE - ONSOLIS

N 022266 001 6159498
7579019

Oct 18, 2016

Jan 22, 2020

DP

FENTANYL CITRATE - ONSOLIS

N 022266 002 6159498
7579019

Oct 18, 2016

Jan 22, 2020

DP

FENTANYL CITRATE - ONSOLIS

N 022266 003 6159498
7579019

Oct 18, 2016

Jan 22, 2020

DP

U-767
U-767
DP
DP
DP
U-1514
U-1514
DP

U-767
U-767
DP
DP
DP
DP
U-1514
U-1514
DP

U-767
U-767
DP
DP
DP
DP
U-1514
U-1514
DP

U-767
U-767
DP
DP
DP
DP
U-1514
U-1514
DP

U-767
U-767
DP
DP
DP
DP
U-1514
U-1514
DP

U-767
U-767

U-767

U-767

U-767

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 83 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FENTANYL CITRATE - ONSOLIS

N 022266 004 6159498
7579019

Oct 18, 2016

Jan 22, 2020

DP

FENTANYL CITRATE - ONSOLIS

N 022266 005 6159498
7579019

Oct 18, 2016

Jan 22, 2020

DP

FENTANYL CITRATE - ABSTRAL

N 022510 001 6759059
6761910
7910132

Sep 24, 2019

Sep 24, 2019
Sep 24, 2019

DP U-767

DP U-767

DP U-767

FENTANYL CITRATE - ABSTRAL

N 022510 002 6759059
6761910
7910132

Sep 24, 2019

Sep 24, 2019
Sep 24, 2019

DP U-767

DP U-767

DP U-767

FENTANYL CITRATE - ABSTRAL

N 022510 003 6759059
6761910
7910132

Sep 24, 2019

Sep 24, 2019
Sep 24, 2019

DP U-767

DP U-767

DP U-767

FENTANYL CITRATE - ABSTRAL

N 022510 004 6759059
6761910
7910132

Sep 24, 2019

Sep 24, 2019
Sep 24, 2019

DP U-767

DP U-767

DP U-767

FENTANYL CITRATE - ABSTRAL

N 022510 005 6759059
6761910
7910132

Sep 24, 2019

Sep 24, 2019
Sep 24, 2019

DP U-767

DP U-767

DP U-767

FENTANYL CITRATE - ABSTRAL

N 022510 006 6759059
6761910
7910132

Sep 24, 2019

Sep 24, 2019
Sep 24, 2019

DP U-767

DP U-767

DP U-767

FENTANYL CITRATE - LAZANDA

N 022569 001 6432440
8216604
8889176
9078814

Apr
Oct
Jan
Jan

20,
03,
16,
08,

2018
2024
2024
2024

DP U-1169

U-767

U-767

DP

FENTANYL CITRATE - LAZANDA

N 022569 002 6432440
8216604
8889176
9078814

Apr
Oct
Jan
Jan

20,
03,
16,
08,

2018
2024
2024
2024

DP U-1169

U-767

U-767

DP

FENTANYL HYDROCHLORIDE - IONSYS

N 021338 001 5697896
Dec 16, 2016
5843014
Dec 01, 2015
6169920
Jan 02, 2018
6181963
Nov 02, 2019
6195582
Jan 28, 2019
6881208
Apr 19, 2022
6975902
Apr 01, 2024
8301238
Sep 30, 2031
8428708
May 21, 2032
8428709
Jun 11, 2032
8781571
Mar 31, 2032
9095706
Feb 03, 2033
FERRIC CARBOXYMALTOSE - INJECTAFER

N 203565 001 7612109
Feb 05, 2024
7754702
Feb 13, 2027
8895612
Jan 08, 2027

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-767

U-767

DP

DP

DP U-736

DP

DP U-736

U-736

DP

DP

U-736

DP U-736

DP U-736

DP

DS DP
DP U-1432

DP U-1620

NP

Jul 25, 2016

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 84 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

FERRIC CITRATE - AURYXIA

N 205874 001 5753706
7767851
8093423
8299298
8338642
8609896
8754257
8754258
8846976
8901349
9050316

PATENT
EXPIRATION
DATE
Feb
Feb
Apr
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

03,
18,
21,
18,
18,
18,
18,
18,
18,
18,
18,

PATENT
CODES

2017
2024
2026
2024
2024
2024
2024
2024
2024
2024
2024

DP U-1577

DS DP

U-1577

DP

DS DP U-1577

DP

DP

DP

U-1577

U-1577

U-1577

FERRIC PYROPHOSPHATE CITRATE - TRIFERIC

N 206317 001 6689275
Dec 31, 2016
6779468
Dec 31, 2016
7816404
Apr 17, 2029

U-1656

U-1656

DP U-1656

FERUMOXYTOL - FERAHEME

N 022180 001 6599498
7553479
7871597
8501158
8591864
8926947

Jun
Mar
Mar
Mar
Mar
Mar

30,
08,
08,
08,
08,
08,

2023
2020
2020
2020
2020
2020

DS DP

DS DP

DS DP

FESOTERODINE FUMARATE - TOVIAZ

N 022030 001 6858650
7384980
7807715
7855230
7985772
8088398
8338478
8501723

Jul
May
Jun
May
May
Jun
May
Jun

03,
11,
07,
11,
11,
07,
11,
07,

2022
2019
2027
2019
2019
2027
2019
2027

DS
U-913

DS DP U-913

DP U-913

U-913

DS DP U-913

DP U-913

DS DP U-913

DP

FESOTERODINE FUMARATE - TOVIAZ

N 022030 002 6858650
7384980
7807715
7855230
7985772
8088398
8338478
8501723

Jul
May
Jun
May
May
Jun
May
Jun

03,
11,
07,
11,
11,
07,
11,
07,

2022
2019
2027
2019
2019
2027
2019
2027

DS
U-913

DS DP U-913

DP U-913

U-913

DS DP U-913

DP U-913

DS DP U-913

DP

FEXOFENADINE HYDROCHLORIDE - ALLEGRA

N 020625 001 6037353
Mar 14, 2017

U-138

U-1422

DP

DS DP

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY

N 020872 005 6037353
Mar 14, 2017
U-1160

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES

N 020872 006 6037353
Mar 14, 2017

U-1160

FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY

N 020872 007 6037353
Mar 14, 2017

U-1160

FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES

N 020872 008 6037353
Mar 14, 2017

U-1160

FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES

N 020872 009 6037353
Mar 14, 2017

U-1160

FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY

N 020872 010 6037353
Mar 14, 2017

U-1160

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY

N 021909 002 6037353
Mar 14, 2017
U-1158

6037353
Mar 14, 2017
U-1466

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ADA 85 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
PATENT
DATE
CODES
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY

N 021909 002 6723348
Nov 26, 2021
DP U-1466

PATENT NO

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES

N 021909 003 6037353
Mar 14, 2017

6723348
Nov 26, 2021
DP

FEXOFENADINE HYDROCHLORIDE - ALLEGRA

N 021963 001 6037353
Mar 14, 2017

U-772

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY

N 201373 001 6037353
Mar 14, 2017
U-1157

8933097
Aug 16, 2032
DP

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES

N 201373 002 6037353
Mar 14, 2017
U-1157

8933097
Aug 16, 2032
DP

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

N 020786 002 6037353
Mar 14, 2017
U-1159

6039974
Jul 31, 2018
DP

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

N 021704 002 6037353
Mar 14, 2017
U-1159

6613357
Dec 25, 2020
DP U-1159

RE39069
May 29, 2018
DP

FIDAXOMICIN - DIFICID

N 201699 001 7378508
7863249
7906489
8586551
8859510

Jul
Jul
Mar
Apr
Jul

31,
31,
04,
12,
31,

2027
2027
2027
2024
2027

DS DP
DS DP

FINAFLOXACIN - XTORO
N 206307 001 6133260
6432948
8536167
9119859

Apr
Apr
Aug
Jul

12,
12,
08,
02,

2017
2017
2031
2030

DS DP
DS DP

FINASTERIDE - PROSCAR
N 020180 001 5942519

Oct 23, 2018

FINGOLIMOD - GILENYA
N 022527 001 5604229
6004565
8324283
9187405

Feb
Sep
Mar
Jun

FLIBANSERIN - ADDYI
N 022526 001 7151103
7420057
8227471

May 09, 2023

Aug 01, 2022
May 09, 2023

DS DP

FLORBETABEN F-18 - NEURACEQ

N 204677 001 7807135

Mar 18, 2029

FLORBETAPIR F-18 - AMYVID

N 202008 001 7687052
8506929

NCE

May 27, 2016

NCE
PED

Dec 17, 2019

Jun 17, 2020

NCE

Sep 21, 2015

NCE

Aug 18, 2020

DS DP U-1497

NCE

Mar 21, 2019

Apr 30, 2027

Apr 30, 2027

DS DP
DS DP U-1423

NCE

Apr 06, 2017

FLORBETAPIR F-18 - AMYVID

N 202008 002 7687052
8506929

Apr 30, 2027

Apr 30, 2027

DS DP
DS DP U-1423

NCE

Apr 06, 2017

FLORBETAPIR F-18 - AMYVID

N 202008 003 7687052
8506929

Apr 30, 2027

Apr 30, 2027

DS DP
DS DP U-1423

NCE

Apr 06, 2017

18,
23,
29,
25,

2019
2017
2026
2027

U-319
DS DP
U-319

U-1679
U-1679

U-280

DS

U-1086
U-1086
U-1086

U-1734
U-1734

ADA 86 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT NO

FLUDARABINE PHOSPHATE - OFORTA

N 022273 001 7148207
7547776

Dec 20, 2022

Dec 10, 2018

FLUNISOLIDE - AEROSPAN HFA

N 021247 001 5776433

Jul 07, 2015

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-944

ODE

Dec 18, 2015

DP

M-128

Aug 28, 2016

NP

Sep 26, 2017

NP

Sep 18, 2018

DS

FLUOCINOLONE ACETONIDE - RETISERT

N 021737 001 6217895
Mar 22, 2019
6548078
Mar 22, 2019

DP U-708
DP U-708

FLUOCINOLONE ACETONIDE - ILUVIEN

N 201923 001 6217895
Mar 22, 2019
6375972
Apr 26, 2020
6548078
Mar 22, 2019
8252307
Jun 27, 2019
8871241
Aug 12, 2027

DP U-1597
DP U-1597
DP U-1597
DP
DP

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN - TRI-LUMA

N 021112 001 7915243
Mar 22, 2026
DP
7939516
May 04, 2025
DP
8247395
Oct 22, 2022
DP
8653053
Oct 25, 2022
DP
FLUOCINONIDE - VANOS
N 021758 001 6765001
7220424
7794738
8232264

Dec
Jan
Sep
Mar

FLUOROURACIL - CARAC
N 020985 001 6670335

Jun 02, 2021

DP U-68

FLUOROURACIL - TOLAK
N 022259 001 7169401

Jul 18, 2023

DP

21,
07,
11,
09,

2021
2023
2022
2023

DP
U-861
U-1084
DP

FLUOXETINE HYDROCHLORIDE - PROZAC

N 018936 001 6960577
Nov 01, 2017

U-963

NPP

Jul 26, 2016

FLUOXETINE HYDROCHLORIDE - PROZAC

N 018936 003 6960577
Nov 01, 2017

U-963

NPP

Jul 26, 2016

NPP

Jul 26, 2016

NPP

Jul 26, 2016

M-142
NPP

Oct 10, 2017

Jul 26, 2016

M-142
NPP

Oct 10, 2017

Jul 26, 2016

M-142
NPP

Oct 10, 2017

Jul 26, 2016

M-142
NPP

Oct 10, 2017

Jul 26, 2016

FLUOXETINE HYDROCHLORIDE - PROZAC

N 018936 004
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 006 6960577
Nov 01, 2017
FLUOXETINE HYDROCHLORIDE - PROZAC WEEKLY
N 021235 001 5910319
May 29,
5985322
May 29,
RE39030
May 29,
RE39030
May 29,

2017
2017
2017
2017

U-963

U-396
U-397
DP U-396
DP U-397

FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX

N 021520 001 6960577
Nov 01, 2017

U-962

FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX

N 021520 002 5945416
Mar 24, 2017
6960577
Nov 01, 2017

DS DP

FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX

N 021520 003 5945416
Mar 24, 2017
6960577
Nov 01, 2017

DS DP

FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX

N 021520 004 5945416
Mar 24, 2017
6960577
Nov 01, 2017

DS DP

U-962

U-962

U-962

ADA 87 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 005 5945416
Mar 24, 2017
6960577
Nov 01, 2017
APPL/PROD
NO

PATENT NO

PATENT
CODES
DS DP

PATENT
DELIST
REQUESTED
Y

U-962

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-142
NPP

Oct 10, 2017

Jul 26, 2016

FLUTEMETAMOL F-18 - VIZAMYL

N 203137 001 7270800
7351401
8236282
8691185
8916131

Apr
Jan
May
Jan
Sep

14,
24,
21,
24,
16,

2027
2023
2024
2023
2028

DS DP U-336
DS DP U-336
DS DP
U-336
DP

NCE

Oct 25, 2018

FLUTEMETAMOL F-18 - VIZAMYL

N 203137 002 7270800
7351401
8236282
8691185
8916131

Apr
Jan
May
Jan
Sep

14,
24,
21,
24,
16,

2027
2023
2024
2023
2028

DS DP U-336
DS DP U-336
DS DP
U-336
DP

NCE

Oct 25, 2018

FLUTICASONE FUROATE - VERAMYST

N 022051 001 6858596
7101866
7541350
8062264
8147461
8347879
8752543

Aug
Aug
Aug
Apr
Oct
Jul
Apr

03,
03,
03,
05,
15,
15,
05,

2021
2021
2021
2026
2028
2028
2026

DP U-808
DS DP U-808
DP U-988
DP
DP
DP
DP

FLUTICASONE FUROATE - ARNUITY ELLIPTA

N 205625 001 5873360
Feb 23,
7101866
Aug 03,
7629335
Aug 03,
8113199
Oct 23,
8161968
Feb 05,
8201556
Feb 05,
8534281
Aug 10,
8746242
Oct 11,

2016
2021
2021
2027
2028
2029
2029
2030

DP
DS DP U-1559
DP
DP
DP
DP
DP
DP

NP

Aug 20, 2017

FLUTICASONE FUROATE - ARNUITY ELLIPTA

N 205625 002 5873360
Feb 23,
7101866
Aug 03,
7629335
Aug 03,
8113199
Oct 23,
8161968
Feb 05,
8201556
Feb 05,
8534281
Aug 10,
8746242
Oct 11,

2016
2021
2021
2027
2028
2029
2029
2030

DP
DS DP U-1559
DP
DP
DP
DP
DP
DP

NP

Aug 20, 2017

I-708
NP

Apr 30, 2018

May 10, 2016

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA

N 204275 001 5873360
Feb 23, 2016
DP
6537983
Aug 03, 2021
DP U-1401
6537983
Aug 03, 2021
DP U-1691
6759398
Aug 03, 2021
DP U-1401
6759398
Aug 03, 2021
DP U-1691
6878698
Aug 03, 2021
U-1401
7101866
Aug 03, 2021
DS DP U-1401
7101866
Aug 03, 2021
DS DP U-1691
7439393
Sep 11, 2022
DS DP U-1401
7439393
Sep 11, 2022
DS DP U-1691
7629335
Aug 03, 2021
DP
7776895
Sep 11, 2022
DP
8113199
Oct 23, 2027
DP
8161968
Feb 05, 2028
DP
8511304
Jun 14, 2027
DP U-1424
8511304
Jun 14, 2027
DP U-1691
8534281
Aug 10, 2029
DP
8746242
Oct 11, 2030
DP
RE44874
Mar 23, 2023
DS DP U-1548
RE44874
Mar 23, 2023
DS DP U-1691

ADA 88 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
PATENT
DATE
CODES
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA

N 204275 002 5873360
Feb 23, 2016
DP
6537983
Aug 03, 2021
DP U-1691
6759398
Aug 03, 2021
DP U-1691
7101866
Aug 03, 2021
DS DP U-1691
7439393
Sep 11, 2022
DS DP U-1691
7629335
Aug 03, 2021
DP
7776895
Sep 11, 2022
DP
8113199
Oct 23, 2027
DP
8161968
Feb 05, 2028
DP
8511304
Jun 14, 2027
DP U-1691
8534281
Aug 10, 2029
DP
8746242
Oct 11, 2030
DP
RE44874
Mar 23, 2023
DS DP U-1691
PATENT NO

FLUTICASONE PROPIONATE - FLOVENT DISKUS 50

N 020833 001 5873360
Feb 23, 2016

DP

FLUTICASONE PROPIONATE - FLOVENT DISKUS 100

N 020833 002 5873360
Feb 23, 2016

DP

FLUTICASONE PROPIONATE - FLOVENT DISKUS 250

N 020833 003 5873360
Feb 23, 2016

DP

FLUTICASONE PROPIONATE - CUTIVATE

N 021152 001 7300669
Oct 20, 2019

DP U-835

FLUTICASONE PROPIONATE - FLOVENT

N 021433 001 6161724
6170717
6315173
6431168
6435372
6510969
6743413
6938796
6966467
6997349
7107986
7107986*PED
7143908
7350676
7500444
7500444*PED
7832351

HFA
Jan
Dec
Dec
Jun
Jan
Dec
Jun
Jan
Dec
Jan
Jun
Dec
Jan
Aug
Feb
Aug
Jun

16,
23,
23,
08,
16,
23,
01,
16,
23,
16,
08,
08,
16,
24,
26,
26,
19,

2018
2017
2017
2018
2018
2017
2021
2018
2017
2018
2018
2018
2018
2018
2026
2026
2023

DP
DP
DP
DP
DP
DP

FLUTICASONE PROPIONATE - FLOVENT

N 021433 002 6161724
6170717
6315173
6431168
6435372
6510969
6743413
6938796
6966467
6997349
7107986
7107986*PED
7143908
7350676
7500444
7500444*PED
7832351

HFA
Jan
Dec
Dec
Jun
Jan
Dec
Jun
Jan
Dec
Jan
Jun
Dec
Jan
Aug
Feb
Aug
Jun

16,
23,
23,
08,
16,
23,
01,
16,
23,
16,
08,
08,
16,
24,
26,
26,
19,

2018
2017
2017
2018
2018
2017
2021
2018
2017
2018
2018
2018
2018
2018
2026
2026
2023

DP
DP
DP
DP
DP
DP

FLUTICASONE PROPIONATE - FLOVENT HFA

N 021433 003 6161724
Jan 16, 2018
6170717
Dec 23, 2017
6315173
Dec 23, 2017
6431168
Jun 08, 2018

U-581
DP
DP
DP
DP
DP
DP
DP
DP

U-581
DP
DP
DP
DP
DP
DP
DP
DP

DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NP

Apr 30, 2018

NPP

Jan 16, 2018

ADA 89 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
FLUTICASONE PROPIONATE - FLOVENT HFA

N 021433 003 6435372
Jan 16, 2018
6510969
Dec 23, 2017
6743413
Jun 01, 2021
6938796
Jan 16, 2018
6966467
Dec 23, 2017
6997349
Jan 16, 2018
7107986
Jun 08, 2018
7107986*PED
Dec 08, 2018

7143908
Jan 16, 2018
7350676
Aug 24, 2018
7500444
Feb 26, 2026
7500444*PED
Aug 26, 2026

7832351
Jun 19, 2023
PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

DP

U-581

DP

DP

DP

DP

DP

DP

DP

DP

FLUTICASONE PROPIONATE - FLONASE ALLERGY RELIEF

N 205434 001
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 100/50

N 021077 001 5873360

Feb 23, 2016
DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 250/50

N 021077 002 5873360

Feb 23, 2016
DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 500/50

N 021077 003 5873360

Feb 23, 2016
DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA

N 021254 001 6161724
Jan 16, 2018
DP

6170717
Dec 23, 2017
DP

6315173
Dec 23, 2017
DP

6431168
Jun 08, 2018
DP

6435372
Jan 16, 2018
DP

6510969
Dec 23, 2017

6743413
Jun 01, 2021
U-1591

6743413*PED
Dec 01, 2021

6938796
Jan 16, 2018
DP

6966467
Dec 23, 2017
DP

6997349
Jan 16, 2018
DP

7107986
Jun 08, 2018
DP

7143908
Jan 16, 2018
DP

7350676
Aug 24, 2018
DP

7500444
Feb 26, 2026
DP

7500444*PED
Aug 26, 2026

7832351
Jun 19, 2023
DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA

N 021254 002 6161724
Jan 16, 2018
DP

6170717
Dec 23, 2017
DP

6315173
Dec 23, 2017
DP

6431168
Jun 08, 2018
DP

6435372
Jan 16, 2018
DP

6510969
Dec 23, 2017
DP

6743413
Jun 01, 2021
U-1591

6743413*PED
Dec 01, 2021

6938796
Jan 16, 2018
DP

6966467
Dec 23, 2017
DP

6997349
Jan 16, 2018
DP

7107986
Jun 08, 2018
DP

7143908
Jan 16, 2018
DP

7350676
Aug 24, 2018
DP

7500444
Feb 26, 2026
DP

7500444*PED
Aug 26, 2026

7832351
Jun 19, 2023
DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA

N 021254 003 6161724
Jan 16, 2018
DP
6170717
Dec 23, 2017
DP
6315173
Dec 23, 2017
DP
6431168
Jun 08, 2018
DP

M-147

Jul 23, 2017

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 90 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
PATENT
DATE
CODES
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N 021254 003 6435372
Jan 16, 2018
DP
6510969
Dec 23, 2017
DP
6743413
Jun 01, 2021
U-1591
6743413*PED
Dec 01, 2021
6938796
Jan 16, 2018
DP
6966467
Dec 23, 2017
DP
6997349
Jan 16, 2018
DP
7107986
Jun 08, 2018
DP
7143908
Jan 16, 2018
DP
7350676
Aug 24, 2018
DP
7500444
Feb 26, 2026
DP
7500444*PED
Aug 26, 2026
7832351
Jun 19, 2023
DP
APPL/PROD
NO

PATENT NO

FLUVASTATIN SODIUM - LESCOL XL

N 021192 001 6242003

Apr 13, 2020

FLUVOXAMINE MALEATE - LUVOX CR

N 022033 001 7465462

May 10, 2020

DP U-929

FLUVOXAMINE MALEATE - LUVOX CR

N 022033 002 7465462

May 10, 2020

DP U-929

FOLLITROPIN ALFA/BETA - GONAL-F

N 020378 004 7563763

Aug 23, 2019

DP

FOLLITROPIN ALFA/BETA - GONAL-F

N 020378 005 7563763

Aug 23, 2019

DP

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N 021211 001 5929028
Jan
5929028
Jan
7446090
Aug
7563763
Aug
7563763
Aug
7563763
Aug

14,
14,
23,
23,
23,
23,

2018
2018
2019
2019
2019
2019

DP U-567
DP U-1366
DP
U-993
U-1183
U-1367

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N 021211 002 5929028
Jan
5929028
Jan
7446090
Aug
7563763
Aug
7563763
Aug
7563763
Aug

14,
14,
23,
23,
23,
23,

2018
2018
2019
2019
2019
2019

DP U-567
DP U-1366
DP
U-993
U-1183
U-1367

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N 021211 003 5929028
Jan
5929028
Jan
7446090
Aug
7563763
Aug
7563763
Aug
7563763
Aug

14,
14,
23,
23,
23,
23,

2018
2018
2019
2019
2019
2019

DP U-567
DP U-1366
DP
U-993
U-1183
U-1367

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N 021211 004 5929028
Jan
5929028
Jan
7446090
Aug
7563763
Aug
7563763
Aug
7563763
Aug

14,
14,
23,
23,
23,
23,

2018
2018
2019
2019
2019
2019

DP U-567
DP U-1366
DP
U-993
U-1183
U-1367

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N 021273 001 5929028
Jan 14, 2018

DP U-1366

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N 021273 002 5929028
Jan 14, 2018

DP U-1366

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 91 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
FOLLITROPIN ALFA/BETA - GONAL-F RFF REDI-JECT
N 021684 001 7446090
Aug 23, 2019
7741268
Apr 02, 2024
APPL/PROD
NO

PATENT NO

PATENT
CODES

DP
DP

FOLLITROPIN ALFA/BETA - GONAL-F RFF REDI-JECT

N 021684 003 7446090
Aug 23, 2019
7741268
Apr 02, 2024

DP
DP

Jun 30, 2027

FORMOTEROL FUMARATE - FORADIL

N 020831 001 6488027
6887459

Mar 08, 2019

Nov 28, 2020

FORMOTEROL FUMARATE - PERFOROMIST

N 022007 001 6667344
Jun
6814953
Jun
7348362
Jun
7462645
Jun
8623922
Jun

22,
22,
22,
22,
22,

2021
2021
2021
2021
2021

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP

FOLLITROPIN ALFA/BETA - GONAL-F RFF REDI-JECT

N 021684 002 7446090
Aug 23, 2019
7741268
Apr 02, 2024

FOMEPIZOLE - ANTIZOL
N 020696 001 7553863

PATENT
DELIST
REQUESTED

DS DP

U-762

DP
DP U-813
DP
DP U-813
DP

FORMOTEROL FUMARATE; MOMETASONE FUROATE - DULERA

N 022518 001 6068832
Aug 27, 2017
7067502
May 21, 2020
7566705
May 21, 2020

DP U-1068
DP U-1068
DP U-1068

FORMOTEROL FUMARATE; MOMETASONE FUROATE - DULERA

N 022518 002 6068832
Aug 27, 2017
7067502
May 21, 2020
7566705
May 21, 2020

DP U-1068
DP U-1068
DP U-1068

FOSAMPRENAVIR CALCIUM - LEXIVA

N 021548 001 6436989
6514953

Dec 24, 2017

Jul 15, 2019

DS DP U-257
DS DP U-257

PED

Oct 27, 2015

FOSAMPRENAVIR CALCIUM - LEXIVA

N 022116 001 6436989

Dec 24, 2017

DS DP U-257

PED

Oct 27, 2015

M-123

Nov 09, 2015

FOSAPREPITANT DIMEGLUMINE - EMEND

N 022023 001 5691336
Mar 04, 2019

DS DP

FOSAPREPITANT DIMEGLUMINE - EMEND

N 022023 002 5691336
Mar 04, 2019

DS DP

FOSPROPOFOL DISODIUM - LUSEDRA

N 022244 001 6204257
6872838

Jul 01, 2022

Aug 07, 2018

DS DP U-945
DS

FROVATRIPTAN SUCCINATE - FROVA

N 021006 001 5464864
5827871

Nov 07, 2015

Oct 27, 2015

U-436
U-436

FULVESTRANT - FASLODEX
N 021344 001 6774122
7456160
8329680
8466139
8466139*PED

Jan
Jan
Jan
Jan
Jul

U-596
U-596
U-596
U-596

GABAPENTIN - NEURONTIN

N 020235 001 6054482

Apr 25, 2017

GABAPENTIN - NEURONTIN

N 020235 002 6054482

Apr 25, 2017

09,
09,
09,
09,
09,

2021
2021
2021
2021
2021

ADA 92 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

GABAPENTIN - NEURONTIN
N 020235 003 6054482

Apr 25, 2017

GABAPENTIN - NEURONTIN
N 020882 001 6054482

Apr 25, 2017

GABAPENTIN - NEURONTIN
N 020882 002 6054482

Apr 25, 2017

GABAPENTIN - NEURONTIN
N 021129 001 6054482
7256216

Apr 25, 2017

May 28, 2022

GABAPENTIN - GRALISE
N 022544 001 6340475
6488962
6635280
6723340
7438927
7731989
8192756
8252332
8333992

Sep
Jun
Sep
Oct
Feb
Oct
Oct
Oct
Oct

19,
20,
19,
25,
26,
25,
25,
25,
25,

2016
2020
2016
2021
2024
2022
2022
2022
2022

DP
DP
DP
DP

GABAPENTIN - GRALISE
N 022544 002 6340475
6488962
6635280
6723340
7438927
7731989
8192756
8252332
8333992

Sep
Jun
Sep
Oct
Feb
Oct
Oct
Oct
Oct

19,
20,
19,
25,
26,
25,
25,
25,
25,

2016
2020
2016
2021
2024
2022
2022
2022
2022

DP
DP
DP
DP

GABAPENTIN ENACARBIL - HORIZANT

N 022399 001 6818787
8026279
8048917
8114909
8686034
8686034
8795725
8795725

Nov
Nov
Nov
Apr
Jan
Jan
Jun
Jun

06,
10,
06,
11,
24,
24,
10,
10,

2022
2026
2022
2026
2025
2025
2029
2029

GABAPENTIN ENACARBIL - HORIZANT

N 022399 002 6818787
8026279
8048917
8114909
8686034
8686034
8795725
8795725

Nov
Nov
Nov
Apr
Jan
Jan
Jun
Jun

06,
10,
06,
11,
24,
24,
10,
10,

2022
2026
2022
2026
2025
2025
2029
2029

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP

ODE

Jan 28, 2018

ODE

Jan 28, 2018

DS DP
DS DP
DS DP U-1247
U-1231
U-1231
U-1247
DP U-1231
DP U-1247

NCE
ODE

Apr 06, 2016

Jun 06, 2019

DS DP
DS DP
DS DP U-1247
U-1231
U-1231
U-1247
DP U-1231
DP U-1247

NCE
ODE

Apr 06, 2016

Jun 06, 2019

GADOBENATE DIMEGLUMINE - MULTIHANCE

N 021357 001

I-654

Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE

N 021357 002

I-654

Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE

N 021357 003

I-654

Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE

N 021357 004

I-654

Jul 06, 2015

GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK

N 021358 001

I-654

Jul 06, 2015

U-1114
DP
DP U-1114
DP U-1114
DP U-1114

U-1114
DP
DP U-1114
DP U-1114
DP U-1114

ADA 93 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK
N 021358 002
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-654

Jul 06, 2015

GADOBUTROL - GADAVIST
N 201277 001 5980864

Nov 09, 2016

DS DP U-1119

I-688
NCE

Jun 11, 2017

Mar 14, 2016

GADOBUTROL - GADAVIST
N 201277 002 5980864

Nov 09, 2016

DS DP U-1119

I-688
NCE

Jun 11, 2017

Mar 14, 2016

GADOBUTROL - GADAVIST
N 201277 003 5980864

Nov 09, 2016

DS DP U-1119

I-688
NCE

Jun 11, 2017

Mar 14, 2016

GADOBUTROL - GADAVIST
N 201277 004 5980864

Nov 09, 2016

DS DP U-1119

I-688
NCE

Jun 11, 2017

Mar 14, 2016

GADOBUTROL - GADAVIST
N 201277 005 5980864

Nov 09, 2016

DS DP U-1119

I-688
NCE

Jun 11, 2017

Mar 14, 2016

I-688
NCE

Jun 11, 2017

Mar 14, 2016

GADOTERATE MEGLUMINE - DOTAREM

N 204781 001

NCE

Mar 20, 2018

GADOTERATE MEGLUMINE - DOTAREM

N 204781 002

NCE

Mar 20, 2018

GADOTERATE MEGLUMINE - DOTAREM

N 204781 003

NCE

Mar 20, 2018

GADOTERATE MEGLUMINE - DOTAREM

N 204781 004

NCE

Mar 20, 2018

M-155

Mar 27, 2018

M-155

Mar 27, 2018

GADOBUTROL - GADAVIST
N 201277 006

GADOFOSVESET TRISODIUM - ABLAVAR

N 021711 001 6676929
May 04, 2020

DP

GADOFOSVESET TRISODIUM - ABLAVAR

N 021711 002 6676929
May 04, 2020

DP

GADOTERIDOL - PROHANCE
N 020131 001 5846519

Dec 08, 2015

GADOTERIDOL - PROHANCE MULTIPACK

N 021489 001 5846519
Dec 08, 2015
GADOXETATE DISODIUM - EOVIST
N 022090 001 5798092
6039931

Aug 25, 2015

Nov 13, 2021

DS DP
U-1239

GADOXETATE DISODIUM - EOVIST

N 022090 002
GALANTAMINE HYDROBROMIDE - RAZADYNE
N 021169 001 6099863
Jun 06, 2017
6358527
Jun 06, 2017

DP U-322

GALANTAMINE HYDROBROMIDE - RAZADYNE

N 021169 002 6099863
Jun 06, 2017
6358527
Jun 06, 2017

DP U-322

GALANTAMINE HYDROBROMIDE - RAZADYNE

N 021169 003 6099863
Jun 06, 2017
6358527
Jun 06, 2017

DP U-322

ADA 94 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N 021615 001 7160559
Dec 20, 2019
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP

GALANTAMINE HYDROBROMIDE - RAZADYNE ER

N 021615 002 7160559
Dec 20, 2019

DP

GALANTAMINE HYDROBROMIDE - RAZADYNE ER

N 021615 003 7160559
Dec 20, 2019

DP

GANCICLOVIR - ZIRGAN
N 022211 001
GANIRELIX ACETATE - GANIRELIX ACETATE
N 021057 001 6653286
Jun 16, 2018

ODE

Sep 15, 2016

NP
ODE

Jul 13, 2018

Jul 13, 2022

NP

Jan 28, 2017

U-1354

GATIFLOXACIN - ZYMAR
N 021493 001 5880283
6333045
6333045*PED

Dec 05, 2015

Aug 20, 2019
Feb 20, 2020

GATIFLOXACIN - ZYMAXID
N 022548 001 5880283

Dec 05, 2015

DS

GEFITINIB - IRESSA
N 021399 001 5770599

May 05, 2017

DS DP U-881

GEFITINIB - IRESSA
N 206995 001 5770599

May 05, 2017

DS DP U-1755

GEMIFLOXACIN MESYLATE - FACTIVE

N 021158 001 5776944
6262071
6331550
6340689
6455540
6723734
6803376
6803376

Apr
Sep
Sep
Sep
Sep
Mar
Sep
Sep

04,
21,
21,
14,
21,
20,
21,
21,

2017
2019
2019
2019
2019
2018
2019
2019

DS DP

GLATIRAMER ACETATE - COPAXONE

N 020622 003 8232250
8399413
8969302
9155776

Aug
Aug
Aug
Aug

19,
19,
19,
19,

2030
2030
2030
2030

DP

U-513
U-511
U-512
U-511
DS DP
DS DP U-608
DS DP U-609

U-441
U-441
U-441
U-441

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT

N 021925 001 6150383
Jun 19, 2016
6211205
Jun 19, 2016
6303640
Aug 09, 2016
6329404
Jun 19, 2016
7538125
Jun 19, 2016
7700128
Jan 30, 2027
8071130
Jun 08, 2028

U-753
U-753
U-753
DP U-753
DP
DP
DP

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT

N 021925 002 6150383
Jun 19, 2016
6211205
Jun 19, 2016
6303640
Aug 09, 2016
6329404
Jun 19, 2016
7538125
Jun 19, 2016
7700128
Jan 30, 2027
8071130
Jun 08, 2028

U-753
U-753
U-753
DP U-753
DP
DP
DP

GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL

N 021700 001 7358366
Apr 19, 2020

DS

GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL

N 021700 002 7358366
Apr 19, 2020

DS

ADA 95 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 003 7358366
Apr 19, 2020

DS

GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL

N 021700 004 7358366
Apr 19, 2020

DS

GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL

N 021700 005 7358366
Apr 19, 2020

DS

APPL/PROD
NO

PATENT NO

PATENT
CODES

GLIPIZIDE - GLUCOTROL XL
N 020329 001 RE44459

Mar 26, 2019

U-1431

GLIPIZIDE - GLUCOTROL XL
N 020329 002 RE44459

Mar 26, 2019

U-1431

GLIPIZIDE - GLUCOTROL XL
N 020329 003 RE44459

Mar 26, 2019

U-1431

GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE

N 021178 001 6303146
Jul 14, 2019

U-412

GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE

N 021178 002 6303146
Jul 14, 2019

U-412

GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE

N 021178 003 6303146
Jul 14, 2019

U-412

GLYCEROL PHENYLBUTYRATE - RAVICTI

N 203284 001 8404215
Mar 09, 2032
8642012
Sep 22, 2030
9095559
Mar 09, 2032

U-1383
U-1383
U-1383

PATENT
DELIST
REQUESTED

GLYCOPYRROLATE - GLYCOPYRROLATE
A 091182 002
GLYCOPYRROLATE - ROBINUL
N 012827 001 7091236

Apr 24, 2024

U-877

GLYCOPYRROLATE - ROBINUL FORTE

N 012827 002 7091236

Apr 24, 2024

U-877

GLYCOPYRROLATE - CUVPOSA
N 022571 001 7638552
7816396

Aug 20, 2023

Aug 20, 2023

U-1076
U-1076

GLYCOPYRROLATE - SEEBRI
N 207923 001 6521260
6528678
7229607
7736670
8029768
8048451
8182838
8303991
8435567
8479730
8580306
8956661

Jan
Apr
Apr
Jun
Apr
Jun
Oct
Jun
Jun
Oct
Jun
Jun

31,
24,
09,
27,
09,
27,
20,
27,
27,
11,
27,
27,

2016
2018
2021
2021
2021
2021
2028
2021
2021
2028
2021
2021

GLYCOPYRROLATE ; INDACATEROL MALEATE - UTIBRON

N 207930 001 6521260
Jan 31, 2016
6582678
Apr 24, 2018
6878721
Oct 10, 2020
7229607
Apr 09, 2021
7736670
Jun 27, 2021
7820694
Jun 02, 2020
8029768
Apr 09, 2021
8048451
Jun 27, 2021
8067437
Jun 02, 2020
8182838
Oct 20, 2028
8283362
Jun 02, 2020

DP
DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NE
ODE

Feb 01, 2016

Feb 01, 2020

PC

Jun 18, 2016

ODE

Jul 28, 2017

NP

Oct 29, 2018

NP

Oct 29, 2018

U-1773
DP
U-1773
DP
DP
DP
DP
DP
DP
DP

DP
DP
DS DP U-1773
U-1773
DP
DP U-1773
U-1773
DP
U-1773
DP
DP U-1773

ADA 96 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
GLYCOPYRROLATE ; INDACATEROL MALEATE - UTIBRON
N 207930 001 8303991
Jun 27, 2021
8435567
Jun 27, 2021
8479730
Oct 11, 2028
8580306
Jun 27, 2021
8658673
Jun 02, 2020
8796307
Jun 02, 2020
8956661
Jun 27, 2021
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP
DP
DP
DP U-1773
DP
DP

GOSERELIN ACETATE - ZOLADEX

N 019726 001 7118552
7220247
7500964

Apr 13, 2022

Apr 09, 2022
Feb 26, 2021

DP
DP
DP

GOSERELIN ACETATE - ZOLADEX

N 020578 001 7118552
7220247
7500964

Apr 13, 2022

Apr 09, 2022
Feb 26, 2021

DP
DP
DP

GRANISETRON - SANCUSO
N 022198 001 7608282

Oct 22, 2024

DP U-1011

GRANISETRON HYDROCHLORIDE - KYTRIL

N 020239 001 5952340
Sep 14, 2016

U-519

GRANISETRON HYDROCHLORIDE - KYTRIL

N 020239 002 5952340
Sep 14, 2016

U-519

GRANISETRON HYDROCHLORIDE - KYTRIL

N 020239 004 5952340
Sep 14, 2016

U-519

GUAIFENESIN - MUCINEX
N 021282 001 6372252
6955821
7838032

Apr 28, 2020

Apr 28, 2020
Apr 28, 2020

U-489
DP U-489
DP

GUAIFENESIN - MUCINEX
N 021282 002 6372252
6955821
7838032

Apr 28, 2020

Apr 28, 2020
Apr 28, 2020

U-489
DP U-489
DP

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D

N 021585 001 6372252
Apr 28, 2020
DP
6955821
Apr 28, 2020
DP U-686
7838032
Apr 28, 2020
DP
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D
N 021585 002 6372252
Apr 28, 2020
DP
6955821
Apr 28, 2020
DP U-686
7838032
Apr 28, 2020
DP
GUANFACINE HYDROCHLORIDE - INTUNIV
N 022037 001 5854290
Sep
5854290*PED
Mar
6287599
Dec
6287599*PED
Jun
6811794
Jul
6811794*PED
Jan

21,
21,
20,
20,
04,
04,

2015
2016
2020
2021
2022
2023

GUANFACINE HYDROCHLORIDE - INTUNIV

N 022037 002 5854290
Sep
5854290*PED
Mar
6287599
Dec
6287599*PED
Jun
6811794
Jul
6811794*PED
Jan

21,
21,
20,
20,
04,
04,

2015
2016
2020
2021
2022
2023

GUANFACINE HYDROCHLORIDE - INTUNIV

N 022037 003 5854290
Sep 21, 2015
5854290*PED
Mar 21, 2016
6287599
Dec 20, 2020

U-494

D-145
M-154
PED

Nov 19, 2017

Mar 18, 2018
May 19, 2018

D-145
M-154
PED

Nov 19, 2017

Mar 18, 2018
May 19, 2018

D-145
M-154
PED

Nov 19, 2017

Mar 18, 2018
May 19, 2018

DP
DP U-494

U-494
DP
DP U-494

U-494
DP

ADA 97 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
GUANFACINE HYDROCHLORIDE - INTUNIV
N 022037 003 6287599*PED
Jun 20, 2021
6811794
Jul 04, 2022
6811794*PED
Jan 04, 2023
APPL/PROD
NO

PATENT NO

GUANFACINE HYDROCHLORIDE - INTUNIV

N 022037 004 5854290
Sep
5854290*PED
Mar
6287599
Dec
6287599*PED
Jun
6811794
Jul
6811794*PED
Jan

21,
21,
20,
20,
04,
04,

2015
2016
2020
2021
2022
2023

PATENT
CODES

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-494

U-494

DP

D-145
M-154
PED

Nov 19, 2017

Mar 18, 2018
May 19, 2018

NP

Oct 25, 2016

DP U-494

HALOBETASOL PROPIONATE - ULTRAVATE

N 208183 001 8962028
Jun 19, 2033

DP U-1775

HEXAMINOLEVULINATE HYDROCHLORIDE
N 022555 001 6034267
7247655
7348361
7530461

U-1087
DP U-1087
DP U-1087
DP U-1087

- CYSVIEW KIT
Mar 08, 2016
Mar 08, 2016
Nov 06, 2020
Jan 11, 2017

PATENT
DELIST
REQUESTED

HISTRELIN ACETATE - SUPPRELIN LA

N 022058 001 8062652
Jun 16, 2026

U-1197

HYALURONIDASE RECOMBINANT HUMAN - HYLENEX RECOMBINANT

N 021859 001 7767429
Sep 23, 2027
DS DP
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - BIDIL
N 020727 001 6465463
Sep 08, 2020
U-71
6784177
Sep 08, 2020
U-71
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N 021532 002 5616599
Apr 25, 2016
DS DP U-500
6878703
Nov 19, 2021
U-3

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT

N 021532 003 5616599
Apr 25, 2016
DS DP U-500
6878703
Nov 19, 2021
U-3

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT

N 021532 005 5616599
Apr 25, 2016
DS DP U-500
6878703
Nov 19, 2021
U-3

HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT

N 021162 001 6358986
Jan 10, 2020
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N 021162 002 6358986
Jan 10, 2020
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 001 6294197
Jun 18, 2017

U-3

HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT

N 020818 002 6294197
Jun 18, 2017

U-3

HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT

N 020818 003 6294197
Jun 18, 2017

U-3

HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT

N 020818 004 6294197
Jun 18, 2017

U-3

HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT

N 020818 005 6294197
Jun 18, 2017

U-3

HYDROCODONE BITARTRATE - ZOHYDRO ER

N 202880 001 6228398
Nov 01, 2019
6902742
Nov 01, 2019
9132096
Sep 12, 2034

DP
DP
DP

ADA 98 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 002 6228398
Nov 01, 2019
6902742
Nov 01, 2019
9132096
Sep 12, 2034
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP
DP

NP

Oct 25, 2016

HYDROCODONE BITARTRATE - ZOHYDRO ER

N 202880 003 6228398
Nov 01, 2019
6902742
Nov 01, 2019
9132096
Sep 12, 2034

DP
DP
DP

NP

Oct 25, 2016

HYDROCODONE BITARTRATE - ZOHYDRO ER

N 202880 004 6228398
Nov 01, 2019
6902742
Nov 01, 2019
9132096
Sep 12, 2034

DP
DP
DP

NP

Oct 25, 2016

HYDROCODONE BITARTRATE - ZOHYDRO ER

N 202880 005 6228398
Nov 01, 2019
6902742
Nov 01, 2019
9132096
Sep 12, 2034

DP
DP
DP

NP

Oct 25, 2016

HYDROCODONE BITARTRATE - ZOHYDRO ER

N 202880 006 6228398
Nov 01, 2019
6902742
Nov 01, 2019
9132096
Sep 12, 2034

DP
DP
DP

NP

Oct 25, 2016

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 001 6488963
Jun
6733783
Oct
8309060
Nov
8361499
Oct
8529948
Aug
8551520
Oct
8647667
Oct
8808740
Dec
9023401
Oct
9056052
Oct
9060940
Oct
9084816
Aug
9095614
Aug
9095615
Aug
9198863
Oct
9205056
Oct

24,
30,
20,
30,
06,
30,
30,
21,
30,
30,
30,
24,
24,
24,
30,
30,

2017
2021
2023
2021
2022
2021
2021
2031
2021
2021
2021
2027
2027
2027
2021
2021

DP
DP U-1556
DP U-1556
DP
DP
DP
DP
DP U-1556
DP
DP
U-1556
DP
U-1556
DP
DP
DP

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 002 6488963
Jun
6733783
Oct
8309060
Nov
8361499
Oct
8529948
Aug
8551520
Oct
8647667
Oct
8808740
Dec
9023401
Oct
9056052
Oct
9060940
Oct
9084816
Aug
9095614
Aug
9095615
Aug
9198863
Oct
9205056
Oct

24,
30,
20,
30,
06,
30,
30,
21,
30,
30,
30,
24,
24,
24,
30,
30,

2017
2021
2023
2021
2022
2021
2021
2031
2021
2021
2021
2027
2027
2027
2021
2021

DP
DP U-1556
DP U-1556
DP
DP
DP
DP
DP U-1556
DP
DP
U-1556
DP
U-1556
DP
DP
DP

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 003 6488963
Jun
6733783
Oct
8309060
Nov
8361499
Oct
8529948
Aug
8551520
Oct
8647667
Oct
8808740
Dec

24,
30,
20,
30,
06,
30,
30,
21,

2017
2021
2023
2021
2022
2021
2021
2031

DP
DP U-1556
DP U-1556
DP
DP
DP
DP
DP U-1556

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 99 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 003 9023401
Oct
9056052
Oct
9060940
Oct
9084816
Aug
9095614
Aug
9095615
Aug
9198863
Oct
9205056
Oct

30,
30,
30,
24,
24,
24,
30,
30,

2021
2021
2021
2027
2027
2027
2021
2021

DP
DP

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 004 6488963
Jun
6733783
Oct
8309060
Nov
8361499
Oct
8529948
Aug
8551520
Oct
8647667
Oct
8808740
Dec
9023401
Oct
9056052
Oct
9060940
Oct
9084816
Aug
9095614
Aug
9095615
Aug
9198863
Oct
9205056
Oct

24,
30,
20,
30,
06,
30,
30,
21,
30,
30,
30,
24,
24,
24,
30,
30,

2017
2021
2023
2021
2022
2021
2021
2031
2021
2021
2021
2027
2027
2027
2021
2021

DP
DP U-1556
DP U-1556
DP
DP
DP
DP
DP U-1556
DP
DP
U-1556
DP
U-1556
DP
DP
DP

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 005 6488963
Jun
6733783
Oct
8309060
Nov
8361499
Oct
8529948
Aug
8551520
Oct
8647667
Oct
8808740
Dec
9056052
Oct
9060940
Oct
9084816
Aug
9095614
Aug
9095615
Aug
9198863
Oct
9205056
Oct

24,
30,
20,
30,
06,
30,
30,
21,
30,
30,
24,
24,
24,
30,
30,

2017
2021
2023
2021
2022
2021
2021
2031
2021
2021
2027
2027
2027
2021
2021

DP
DP U-1556
DP U-1556
DP
DP
DP
DP
DP U-1556
DP
U-1556
DP
U-1556
DP
DP
DP

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 006 6488963
Jun
6733783
Oct
8309060
Nov
8361499
Oct
8529948
Aug
8551520
Oct
8647667
Oct
8808740
Dec
9056052
Oct
9060940
Oct
9084816
Aug
9095614
Aug
9095615
Aug
9198863
Oct
9205056
Oct

24,
30,
20,
30,
06,
30,
30,
21,
30,
30,
24,
24,
24,
30,
30,

2017
2021
2023
2021
2022
2021
2021
2031
2021
2021
2027
2027
2027
2021
2021

DP
DP U-1556
DP U-1556
DP
DP
DP
DP
DP U-1556
DP
U-1556
DP
U-1556
DP
DP
DP

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 007 6488963
Jun
6733783
Oct
8309060
Nov
8361499
Oct
8529948
Aug
8551520
Oct
8647667
Oct

24,
30,
20,
30,
06,
30,
30,

2017
2021
2023
2021
2022
2021
2021

DP
DP U-1556
DP U-1556
DP
DP
DP
DP

U-1556
DP
U-1556
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 100 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

HYDROCODONE BITARTRATE - HYSINGLA

N 206627 007 8808740
Dec
9056052
Oct
9060940
Oct
9084816
Aug
9095614
Aug
9095615
Aug
9198863
Oct
9205056
Oct

21,
30,
30,
24,
24,
24,
30,
30,

2031
2021
2021
2027
2027
2027
2021
2021

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-1556
DP
U-1556
DP
U-1556
DP
DP
DP

HYDROCODONE BITARTRATE; IBUPROFEN - VICOPROFEN

N 020716 001 6348216
Jun 10, 2017
6599531
Jun 10, 2017
HYDROCORTISONE BUTYRATE - LOCOID
N 022076 001 7378405
Dec 19, 2026
7981877
Jan 23, 2025

DP
DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP

N 019034 001 6589960
Nov 09, 2020

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP

N 019034 002 6589960
Nov 09, 2020

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019034 003 6589960
Nov 09, 2020

DS DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019034 004 6589960
Nov 09, 2020

DS DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019034 005 6589960
Nov 09, 2020

DS DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019891 001 6589960
Nov 09, 2020

DS DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019892 001 6589960
Nov 09, 2020

DS DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019892 002 6589960
Nov 09, 2020

DS DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019892 003 6589960
Nov 09, 2020

DS DP

HYDROMORPHONE HYDROCHLORIDE - PALLADONE

N 021044 001 6589960
Nov 09, 2020

DP

HYDROMORPHONE HYDROCHLORIDE - PALLADONE

N 021044 002 6589960
Nov 09, 2020

DP

HYDROMORPHONE HYDROCHLORIDE - PALLADONE

N 021044 003 6589960
Nov 09, 2020

DP

HYDROMORPHONE HYDROCHLORIDE - PALLADONE

N 021044 004 6589960
Nov 09, 2020

DP

HYDROXOCOBALAMIN - CYANOKIT
N 022041 001 5834448

Nov 14, 2016

DP

HYDROXOCOBALAMIN - CYANOKIT
N 022041 002 5834448

Nov 14, 2016

DP U-789

HYDROXYPROGESTERONE CAPROATE - MAKENA

N 021945 001
IBANDRONATE SODIUM - BONIVA
N 021455 001 6143326
6294196

Apr 21, 2017

Oct 07, 2019

ODE

U-642
DP

Feb 03, 2018

ADA 101 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

IBANDRONATE SODIUM - BONIVA

N 021455 002 6294196
7192938
7410957
7718634

Oct
May
May
May

07,
06,
06,
06,

2019
2023
2023
2023

IBRUTINIB - IMBRUVICA

N 205552 001 7514444
8008309
8476284
8476284
8497277
8497277
8497277
8697711
8703780
8735403
8754090
8754091
8957079
8999999
8999999
9125889
9181257

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jun
Dec
Dec
Jun
Jun
Jun
Dec

28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
03,
28,
28,
03,
03,
03,
28,

2026
2026
2026
2026
2026
2026
2026
2026
2026
2026
2031
2026
2026
2031
2031
2031
2026

IBUPROFEN - MIDOL LIQUID GELS

N 021472 001 6251426

Jun 25, 2018

IBUPROFEN - CALDOLOR

N 022348 001 6727286

Nov 27, 2021

DP U-981

IBUPROFEN - CALDOLOR

N 022348 002 6727286
8735452
8871810
9012508
9114068
9138404

Nov
Sep
Sep
Sep
Sep
Sep

27,
30,
30,
14,
30,
30,

2021
2029
2029
2030
2029
2029

DP U-981
U-981
U-1599

U-981

U-1735

U-1756

IBUPROFEN LYSINE - NEOPROFEN

N 021903 001 6342530
6342530
6344479
8415337

Nov
Nov
Mar
Mar

14,
14,
20,
02,

2020
2020
2021
2032

DP U-794

DP U-1127

DS DP U-794
DS DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

U-798

U-887

U-642

DS DP
DS DP
U-1456
U-1491
U-1456
U-1491
U-1650
DS DP

I-680
I-689
I-702
NCE
ODE
ODE
ODE
ODE

Feb
Jul
Jan
Nov
Nov
Feb
Jul
Jan

12,
28,
29,
13,
13,
12,
28,
29,

2017

2017

2018

2018

2020

2021

2021

2022

D-152
NPP

Nov 20, 2018

Nov 20, 2018

NCE
ODE

Aug 25, 2016

Aug 25, 2018

U-1491

DS DP

U-1456

DP

DS DP

U-1683

U-1684

U-1745

DS DP

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - CHILDREN'S MOTRIN COLD

N 021128 001 6211246
Jun 10, 2019

ICATIBANT ACETATE - FIRAZYR

N 022150 001 5648333

Jul 15, 2019

DS DP U-1187

ICODEXTRIN - EXTRANEAL

N 021321 001 6077836
6248726

Jun 20, 2017

Jun 19, 2018

U-495

U-495

ICOSAPENT ETHYL - VASCEPA

N 202057 001 8188146
8293727
8293728
8298554
8314086
8318715
8357677
8367652
8377920
8399446
8415335
8426399
8431560

Jan
Feb
Feb
Apr
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

27,
09,
09,
29,
09,
09,
09,
09,
09,
09,
09,
09,
09,

2020
2030
2030
2030
2030
2030
2030
2030
2030
2030
2030
2030
2030

DS DP

U-1287

U-1287

DP

U-1287

U-1287

U-1287

U-1287

U-1287

U-1287

U-1287

U-1287

U-1287

ADA 102 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ICOSAPENT ETHYL - VASCEPA

N 202057 001 8440650
8445003
8445013
8501225
8518929
8524698
8546372
8551521
8563608
8617593
8617594
8623406

Feb
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

09,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,

2030
2030
2030
2030
2030
2030
2030
2030
2030
2030
2030
2030

IDELALISIB - ZYDELIG

N 205858 001 6800620
6949535
8138195
8492389
8637533
8865730
8980901
9149477
RE44599
RE44599
RE44638

Apr
Apr
Apr
Apr
Apr
Mar
May
May
Jul
Jul
Aug

24,
24,
24,
24,
24,
05,
12,
12,
21,
21,
05,

2021
2021
2021
2021
2021
2033
2025
2025
2025
2025
2025

DS
DS
DS
DS
DS
DS

U-1560
U-1560

DP U-1549

DP

DP

DP U-1615

U-1678

U-1757

U-1558

U-1615

DS DP

NCE

Jul 23, 2019

IDELALISIB - ZYDELIG

N 205858 002 6800620
6949535
8138195
8492389
8637533
8865730
8980901
9149477
RE44599
RE44599
RE44638

Apr
Apr
Apr
Apr
Apr
Mar
May
May
Jul
Jul
Aug

24,
24,
24,
24,
24,
05,
12,
12,
21,
21,
05,

2021
2021
2021
2021
2021
2033
2025
2025
2025
2025
2025

DS
DS
DS
DS
DS
DS

NCE

Jul 23, 2019

ILOPERIDONE - FANAPT

N 022192 001 8586610
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
RE39198

Nov
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
Nov

02,
31,
28,
16,
28,
17,
10,
30,
05,
15,

2027
2030
2030
2031
2031
2030
2031
2025
2030
2016

U-1625

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

DS DP U-971

ILOPERIDONE - FANAPT

N 022192 002 8586610
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
RE39198

Nov
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
Nov

02,
31,
28,
16,
28,
17,
10,
30,
05,
15,

2027
2030
2030
2031
2031
2030
2031
2025
2030
2016

U-1625

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

DS DP U-971

ILOPERIDONE - FANAPT
N 022192 003 8586610
8652776
8999638
9072742
9074254

Nov
Aug
Oct
Jan
Dec

02,
31,
28,
16,
28,

2027
2030
2030
2031
2031

U-1287

U-1287

U-1287

U-1287

U-1287

U-1287

U-1287

U-1287

U-1287

U-1478

U-1287

U-1478

U-1560
U-1560

DP U-1549

DP

DP

DP U-1615

U-1678

U-1757

U-1558

U-1615

DS DP

U-1625
U-1685
U-1674
U-1674
U-1674

ADA 103 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ILOPERIDONE - FANAPT

N 022192 003 9074255
9074256
9138432
9157121
RE39198

Dec
Feb
Sep
Apr
Nov

17,
10,
30,
05,
15,

2030
2031
2025
2030
2016

U-1674

U-1674

U-1737

U-1674

DS DP U-971

ILOPERIDONE - FANAPT

N 022192 004 8586610
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
RE39198

Nov
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
Nov

02,
31,
28,
16,
28,
17,
10,
30,
05,
15,

2027
2030
2030
2031
2031
2030
2031
2025
2030
2016

U-1625

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

DS DP U-971

ILOPERIDONE - FANAPT

N 022192 005 8586610
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
RE39198

Nov
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
Nov

02,
31,
28,
16,
28,
17,
10,
30,
05,
15,

2027
2030
2030
2031
2031
2030
2031
2025
2030
2016

U-1625

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

DS DP U-971

ILOPERIDONE - FANAPT

N 022192 006 8586610
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
RE39198

Nov
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
Nov

02,
31,
28,
16,
28,
17,
10,
30,
05,
15,

2027
2030
2030
2031
2031
2030
2031
2025
2030
2016

U-1625

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

DS DP U-971

ILOPERIDONE - FANAPT

N 022192 007 8586610
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121
RE39198

Nov
Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr
Nov

02,
31,
28,
16,
28,
17,
10,
30,
05,
15,

2027
2030
2030
2031
2031
2030
2031
2025
2030
2016

U-1625

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

DS DP U-971

IMATINIB MESYLATE - GLEEVEC

N 021335 001 6894051
6958335
RE43932
RE43932*PED

May
Dec
Jan
Jul

23,
19,
16,
16,

2019
2021
2019
2019

DS DP U-649

U-791

DS DP

IMATINIB MESYLATE - GLEEVEC

N 021335 002 6894051
6958335
RE43932
RE43932*PED

May
Dec
Jan
Jul

23,
19,
16,
16,

2019
2021
2019
2019

DS DP U-649

U-791

DS DP

IMATINIB MESYLATE - GLEEVEC

N 021588 001 6894051
6958335

May 23, 2019

Dec 19, 2021

DS DP U-649
U-791

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

I-666
ODE

EXCLUSIVITY

EXPIRATION

DATE

Jan 25, 2016

Dec 19, 2015

ADA 104 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

IMATINIB MESYLATE - GLEEVEC

N 021588 001 7544799
7544799*PED
RE43932
RE43932*PED

Jan
Jul
Jan
Jul

16,
16,
16,
16,

2019
2019
2019
2019

DS DP

IMATINIB MESYLATE - GLEEVEC

N 021588 002 6894051
6958335
7544799
7544799*PED
RE43932
RE43932*PED

May
Dec
Jan
Jul
Jan
Jul

23,
19,
16,
16,
16,
16,

2019
2021
2019
2019
2019
2019

DS DP U-649
U-791
DS DP

IMIQUIMOD - ALDARA
N 020723 001 7696159
7696159

Apr 01, 2024

Apr 01, 2024

IMIQUIMOD - ZYCLARA
N 022483 001 8236816
8299109
8598196
8598196

Dec
Dec
Aug
Aug

IMIQUIMOD - ZYCLARA
N 022483 002 8222270

Dec 11, 2029

11,
11,
18,
18,

INDACATEROL MALEATE - ARCAPTA NEOHALER

N 022383 001 6878721
Oct 10,
8067437
Jun 02,
8479730
Oct 11,
8658673
Jun 02,
8796307
Jun 02,

DS
DS

ODE

Jan 25, 2020

I-666
ODE
ODE

Jan 25, 2016

Dec 19, 2015
Jan 25, 2020

NCE

Jul 01, 2016

NP

Feb 24, 2017

NP

Feb 24, 2017

M-169
NCE

Nov 19, 2018

Jan 23, 2017

U-68
U-68
U-172
U-1455

U-68

DS DP U-1168
U-1168
DP
DS DP U-1168
DS DP

DP

INDINAVIR SULFATE - CRIXIVAN

N 020685 003 6645961
6689761

Mar 04, 2018

Feb 10, 2021

DP

INDINAVIR SULFATE - CRIXIVAN

N 020685 005 6645961
6689761

Mar 04, 2018

Feb 10, 2021

DP

INDINAVIR SULFATE - CRIXIVAN

N 020685 006 6645961
6689761

Mar 04, 2018

Feb 10, 2021

DP

U-554

U-554

U-554

U-554

DS DP
U-1125

INDOMETHACIN - TIVORBEX
N 204768 001 8734847
8992982
9089471

Apr 23, 2030

Apr 23, 2030
Apr 23, 2030

DP
DP

INDOMETHACIN - TIVORBEX
N 204768 002 8734847
8992982
9089471

Apr 23, 2030

Apr 23, 2030
Apr 23, 2030

DP
DP

INGENOL MEBUTATE - PICATO

N 202833 001 6432452
6787161
6844013
7410656
8278292
8372827

Aug
Aug
Dec
Aug
Jul
Dec

2018
2018
2018
2018
2027
2026

U-1047
U-1048

Mar 04, 2018

Feb 10, 2021

19,
19,
13,
19,
06,
18,

EXCLUSIVITY
EXPIRATION
DATE

DS DP

INDINAVIR SULFATE - CRIXIVAN

N 020685 001 6645961
6689761

INDIUM IN-111 PENTETREOTIDE KIT - OCTREOSCAN

N 020314 001 5776894
Jul 07, 2015
6123916
Sep 26, 2017

EXCLUSIVITY
CODE(S)

DS DP

2029
2029
2029
2029

2020
2020
2028
2020
2020

PATENT
DELIST
REQUESTED

U-55

U-55

U-68
U-68
U-1221
U-1222

DP

DP

ADA 105 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

INGENOL MEBUTATE - PICATO

N 202833 001 8372828
8377919
8536163
8716271
8735375

Dec
Dec
Dec
Dec
Dec

18,
18,
18,
18,
18,

2026
2026
2026
2026
2026

INGENOL MEBUTATE - PICATO

N 202833 002 6432452
6787161
6844013
7410656
8278292
8372827
8372828
8377919
8536163
8716271
8735375

Aug
Aug
Dec
Aug
Jul
Dec
Dec
Dec
Dec
Dec
Dec

19,
19,
13,
19,
06,
18,
18,
18,
18,
18,
18,

2018
2018
2018
2018
2027
2026
2026
2026
2026
2026
2026

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

DP

U-1440

U-1440

U-1440

U-68
U-68
U-1221

U-1222

M-169
NCE

Nov 19, 2018

Jan 23, 2017

DP

DP

DP

DP

U-1440

U-1440

U-1440

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30

N 021172 001 5866538

Jun 20, 2017
DP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 PENFILL

N 021172 002 5866538

Jun 19, 2017
DP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 PENFILL

N 021172 003 5866538

Jun 19, 2017
DP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 FLEXPEN

N 021172 004 5866538

Jun 20, 2017
DP

6004297
Jan 28, 2019
DP

RE41956
Jan 21, 2021
DP

RE43834
Jan 28, 2019
DP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 50/50

N 021810 001 5866538

Jun 20, 2017
DP

INSULIN ASPART RECOMBINANT - NOVOLOG

N 020986 001 5866538
Jun 20, 2017

DP

INSULIN ASPART RECOMBINANT - NOVOLOG PENFILL

N 020986 002 5866538
Jun 20, 2017

DP

INSULIN ASPART RECOMBINANT - NOVOLOG FLEXPEN

N 020986 003 5866538
Jun 20, 2017
6004297
Jan 28, 2019
RE41956
Jan 21, 2021
RE43834
Jan 28, 2019

DP

DP

DP

DP

INSULIN ASPART RECOMBINANT - NOVOLOG INNOLET

N 020986 004 5866538
Jun 20, 2017
RE41956
Jan 21, 2021

DP

DP

INSULIN ASPART RECOMBINANT - NOVOLOG FLEXTOUCH

N 020986 005 5866538
Jun 20, 2017
5866538*PED
Dec 20, 2017

6899699
Jan 02, 2022
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

DP

DP

DP

DP

DP

DP

DP

DP

INSULIN ASPART; INSULIN DEGLUDEC - RYZODEG 70/30

N 203313 001 5866538

Jun 20, 2017
DP
6899699
Jan 02, 2022
DP

7615532
May 25, 2025
DS DP

7686786
Aug 03, 2026
DP

NCE

Sep 25, 2020

ADA 106 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
INSULIN ASPART; INSULIN DEGLUDEC - RYZODEG 70/30
N 203313 001 8672898
Jan 02, 2022
8684969
Oct 20, 2025
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP
DP
DP
DP

INSULIN DEGLUDEC - TRESIBA

N 203314 001 6899699
7615532
7686786
8672898
8684969
8920383
9108002
9132239

Jan
May
Aug
Jan
Oct
Jul
Jan
Feb

02,
25,
03,
02,
20,
17,
20,
01,

2022
2025
2026
2022
2025
2026
2026
2032

DP
DS DP
DP
DP
DP
DP
DP
DP

NCE

Sep 25, 2020

INSULIN DEGLUDEC - TRESIBA

N 203314 002 6899699
7615532
7686786
8672898
8684969
8920383
9108002
9132239

Jan
May
Aug
Jan
Oct
Jul
Jan
Feb

02,
25,
03,
02,
20,
17,
20,
01,

2022
2025
2026
2022
2025
2026
2026
2032

DP
DS DP
DP
DP
DP
DP
DP
DP

NCE

Sep 25, 2020

NP

Dec 16, 2018

INSULIN DETEMIR RECOMBINANT - LEVEMIR

N 021536 001 5750497
Jun 16, 2019
5866538
Jun 20, 2017

DS DP U-668
DS DP

INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXPEN

N 021536 002 5750497
Jun 16, 2019
5866538
Jun 20, 2017
6004297
Jan 28, 2019
RE41956
Jan 21, 2021
RE43834
Jan 28, 2019

DS DP U-668
DS DP
DP
DP
DP

INSULIN DETEMIR RECOMBINANT - LEVEMIR INNOLET

N 021536 003 5750497
Jun 16, 2019
5866538
Jun 20, 2017

DS DP U-668
DS DP

INSULIN DETEMIR RECOMBINANT - LEVEMIR PENFILL

N 021536 004 5750497
Jun 16, 2019
5866538
Jun 20, 2017

DS DP U-668
DS DP

INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXTOUCH

N 021536 005 5750497
Jun 16, 2019
5866538
Jun 20, 2017
6899699
Jan 02, 2022
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

DS DP U-668
DP
DP
DP
DP
DP
DP
DP
DP

INSULIN GLARGINE - BASAGLAR

N 205692 001
INSULIN GLARGINE RECOMBINANT - LANTUS
N 021081 001 7476652
Jul 23, 2023
7713930
Jun 13, 2023
7918833
Sep 23, 2027

DP
DP
DP

INSULIN GLARGINE RECOMBINANT - LANTUS SOLOSTAR

N 021081 002 8512297
Sep 15, 2024
8556864
Mar 03, 2024
8603044
Mar 02, 2024
8679069
Apr 12, 2025

DP
DP
DP
DP

ADA 107 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
INSULIN GLARGINE RECOMBINANT - LANTUS SOLOSTAR

N 021081 002 8992486
Jun 05, 2024
9011391
Mar 26, 2024
PATENT NO

INSULIN GLARGINE RECOMBINANT - TOUJEO SOLOSTAR

N 206538 001 7918833
Sep 23, 2027
7918833*PED
Mar 23, 2028

8512297
Sep 15, 2024
8556864
Mar 03, 2024
8603044
Mar 02, 2024
8679069
Apr 12, 2025
8992486
Jun 05, 2024
9011391
Mar 26, 2024

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

DP

DP

NP

Feb 25, 2018

DP

DP

DP

DP

DP

DP

INSULIN GLULISINE RECOMBINANT - APIDRA

N 021629 001 6221633
Jun 18,
6960561
Jan 25,
7452860
Mar 22,
7696162
Mar 22,

2018
2023
2022
2022

DS DP U-471

DP U-471

DP

DP U-471

INSULIN GLULISINE RECOMBINANT - APIDRA

N 021629 002 6221633
Jun 18,
6960561
Jan 25,
7452860
Mar 22,
7696162
Mar 22,

2018
2023
2022
2022

DS DP U-471

DP U-471

DP

DP U-471

INSULIN GLULISINE RECOMBINANT - APIDRA SOLOSTAR

N 021629 003 6221633
Jun 18, 2018
DS DP U-471

6960561
Jan 25, 2023
DP U-471

7452860
Mar 22, 2022
DP

7696162
Mar 22, 2022
DP U-471

7918833
Sep 23, 2027
DP

8512297
Sep 15, 2024
DP

8556864
Mar 03, 2024
DP

8603044
Mar 02, 2024
DP

8679069
Apr 12, 2025
DP

8992486
Jun 05, 2024
DP

9011391
Mar 26, 2024
DP

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 75/25 KWIKPEN

N 021017 002 7291132

Aug 09, 2024
DP

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 50/50 KWIKPEN

N 021018 002 7291132

Aug 09, 2024
DP

INSULIN LISPRO RECOMBINANT - HUMALOG

N 020563 001

NR

Oct 12, 2015

INSULIN LISPRO RECOMBINANT - HUMALOG PEN

N 020563 002

NR

Oct 12, 2015

INSULIN LISPRO RECOMBINANT - HUMALOG KWIKPEN

N 020563 003 7291132
Aug 09, 2024

DP

INSULIN LISPRO RECOMBINANT - HUMALOG KWIKPEN

N 205747 001 6034054
Jun 11, 2018
6034054
Jun 11, 2018
6551992
Jun 11, 2018
6551992
Jun 11, 2018
7291132
Aug 09, 2024

DP U-1707

DP U-1708

DP U-1707

DP U-1708

DP

INSULIN RECOMBINANT HUMAN - EXUBERA

N 021868 001 6257233
May 14, 2019
6546929
May 14, 2019
6582728
Jun 24, 2020
6685967
Sep 11, 2018
INSULIN RECOMBINANT HUMAN - EXUBERA

N 021868 002 6257233
May 14, 2019
6546929
May 14, 2019

U-704

U-704

DP

DP

U-704

U-704

ADA 108 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
INSULIN RECOMBINANT HUMAN - EXUBERA
N 021868 002 6582728
Jun 24, 2020
6685967
Sep 11, 2018
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP

INSULIN RECOMBINANT HUMAN - AFREZZA

N 022472 001 6444226
Jun
6652885
Jun
7305986
Jan
7464706
Mar
7648960
Jun
7943178
Jun
7943572
Aug
8119593
Aug
8146588
Apr
8156936
Jan
8215300
Nov
8227409
Mar
8258095
Aug
8389470
Jun
8424518
Oct
8485180
Mar
8499757
Feb
8551528
Jun
8623817
Sep
8636001
Jul
8729019
Dec
8734845
Jun
8778403
Jun
8889099
Jun
8912193
Jun
9192675
Jun

29,
29,
16,
02,
29,
29,
10,
11,
24,
16,
24,
08,
11,
29,
17,
25,
19,
11,
18,
12,
26,
11,
11,
29,
12,
12,

2020
2020
2023
2023
2020
2020
2026
2029
2023
2023
2022
2031
2029
2020
2031
2030
2032
2030
2029
2032
2028
2030
2030
2020
2029
2029

DP U-1534
U-1535
DP
DP
U-1535
DP U-1535
U-1539
U-1537
DP
DP
DP
DP U-1538
U-1537
DP
DP
DP
DP
DP
U-1537
DP
DP
DP
DP U-1538
DP U-1621
DP U-1538
DP U-1788

NP

Jun 27, 2017

INSULIN RECOMBINANT HUMAN - AFREZZA

N 022472 002 6444226
Jun
6652885
Jun
7305986
Jan
7464706
Mar
7648960
Jun
7943178
Jun
7943572
Aug
8119593
Aug
8146588
Apr
8156936
Jan
8215300
Nov
8227409
Mar
8258095
Aug
8389470
Jun
8424518
Oct
8485180
Mar
8499757
Feb
8551528
Jun
8623817
Sep
8636001
Jul
8729019
Dec
8734845
Jun
8778403
Jun
8889099
Jun
8912193
Jun
9192675
Jun

29,
29,
16,
02,
29,
29,
10,
11,
24,
16,
24,
08,
11,
29,
17,
25,
19,
11,
18,
12,
26,
11,
11,
29,
12,
12,

2020
2020
2023
2023
2020
2020
2026
2029
2023
2023
2022
2031
2029
2020
2031
2030
2032
2030
2029
2032
2028
2030
2030
2020
2029
2029

DP U-1534
U-1535
DP
DP
U-1535
DP U-1535
U-1539
U-1537
DP
DP
DP
DP U-1538
U-1537
DP
DP
DP
DP
DP
U-1537
DP
DP
DP
DP U-1538
DP U-1621
DP U-1538
DP U-1788

NP

Jun 27, 2017

INSULIN RECOMBINANT HUMAN - AFREZZA

N 022472 003 6444226
Jun
6652885
Jun
7305986
Jan
7464706
Mar
7648960
Jun
7943178
Jun
7943572
Aug
8119593
Aug
8146588
Apr

29,
29,
16,
02,
29,
29,
10,
11,
24,

2020
2020
2023
2023
2020
2020
2026
2029
2023

DP U-1534
U-1535
DP
DP
U-1535
DP U-1535
U-1539
U-1537
DP

NP

Jun 27, 2017

ADA 109 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
INSULIN RECOMBINANT HUMAN - AFREZZA

N 022472 003 8156936
Jan 16, 2023
8215300
Nov 24, 2022
8258095
Aug 11, 2029
8389470
Jun 29, 2020
8424518
Oct 17, 2031
8485180
Mar 25, 2030
8499757
Feb 19, 2032
8551528
Jun 11, 2030
8623817
Sep 18, 2029
8636001
Jul 12, 2032
8729019
Dec 26, 2028
8734845
Jun 11, 2030
8778403
Jun 11, 2030
8889099
Jun 29, 2020
8912193
Jun 12, 2029
9192675
Jun 12, 2029
PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

DP

U-1537

DP U-1697

DP

DP

DP

DP

U-1537

DP

DP

DP

DP U-1538

DP U-1621

DP U-1538

DP U-1788

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN 70/30

N 019717 001 7291132

Aug 09, 2024
DP

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN 70/30 PEN

N 019717 002 7291132

Aug 09, 2024
DP

INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN N

N 018781 001 7291132
Aug 09, 2024
DP

IOBENGUANE SULFATE I-123 - ADREVIEW

N 022290 001

I-669
ODE

Mar 20, 2016

Sep 19, 2015

NCE

Jan 14, 2016

NP

Oct 22, 2018

IRON SUCROSE - VENOFER

N 021135 001

NPP

Sep 21, 2015

IRON SUCROSE - VENOFER

N 021135 002

NPP

Sep 21, 2015

IRON SUCROSE - VENOFER

N 021135 005

NPP

Sep 21, 2015

NCE
ODE
GAIN
GAIN

Mar
Mar
Mar
Mar

IOFLUPANE I-123 - DATSCAN

N 022454 001
IPRATROPIUM BROMIDE - ATROVENT HFA

N 021527 001 6739333
May 26, 2020
6983743
May 26, 2020
8474447
Jan 17, 2030

DP

DP

DP

IRINOTECAN HYDROCHLORIDE - CAMPTOSAR

N 020571 001 6403569
Apr 28, 2020
6794370
May 01, 2020

U-449

U-606

IRINOTECAN HYDROCHLORIDE - CAMPTOSAR

N 020571 002 6403569
Apr 28, 2020
6794370
May 01, 2020

U-449

U-606

IRINOTECAN HYDROCHLORIDE - ONIVYDE

N 207793 001 8147867
Aug
8329213
May
8703181
May
8992970
May
IRON DEXTRAN - DEXFERRUM

N 040024 001 5624668

29,
02,
02,
02,

2028
2025
2025
2025

DS DP
DS DP

U-1434

DS DP

Sep 29, 2015

ISAVUCONAZONIUM SULFATE - CRESEMBA

N 207500 001 6812238
Oct 31, 2020
7459561
Oct 31, 2020

DS
DS

06,
06,
06,
06,

2020

2022

2025

2027

ADA 110 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
ISAVUCONAZONIUM SULFATE - CRESEMBA
N 207501 001 6812238
Oct 31, 2020
7459561
Oct 31, 2020
PATENT NO

PATENT
CODES
DS
DS

ISOTRETINOIN - ABSORICA
N 021951 001 7435427
8367102
8952064
9078925
9089534

Sep
Sep
Sep
Sep
Sep

21,
21,
21,
21,
21,

2021
2021
2021
2021
2021

DP

ISOTRETINOIN - ABSORICA
N 021951 002 7435427
8367102
8952064
9078925
9089534

Sep
Sep
Sep
Sep
Sep

21,
21,
21,
21,
21,

2021
2021
2021
2021
2021

DP

ISOTRETINOIN - ABSORICA
N 021951 003 7435427
8367102
8952064
9078925
9089534

Sep
Sep
Sep
Sep
Sep

21,
21,
21,
21,
21,

2021
2021
2021
2021
2021

DP

ISOTRETINOIN - ABSORICA
N 021951 004 7435427
8367102
8952064
9078925
9089534

Sep
Sep
Sep
Sep
Sep

21,
21,
21,
21,
21,

2021
2021
2021
2021
2021

DP

ISOTRETINOIN - ABSORICA
N 021951 005 7435427
8367102
8952064
9078925
9089534

Sep
Sep
Sep
Sep
Sep

21,
21,
21,
21,
21,

2021
2021
2021
2021
2021

DP

ISOTRETINOIN - ABSORICA
N 021951 006 7435427
8367102
8952064
9078925
9089534

Sep
Sep
Sep
Sep
Sep

21,
21,
21,
21,
21,

2021
2021
2021
2021
2021

DP

ITRACONAZOLE - SPORANOX
N 020657 001 6407079

Jun 18, 2019

ITRACONAZOLE - SPORANOX
N 020966 001 6407079

Jun 18, 2019

ITRACONAZOLE - ONMEL
N 022484 001 6509038
7081255
8486456
8591948

May
May
Oct
May

12,
12,
03,
12,

2017
2017
2028
2017

IVABRADINE HYDROCHLORIDE - CORLANOR

N 206143 001 7361649
Apr
7361650
Apr
7867996
Feb
7879842
Feb

17,
14,
22,
22,

2026
2026
2026
2026

IVABRADINE HYDROCHLORIDE - CORLANOR

N 206143 002 7361649
Apr 17, 2026
7361650
Apr 14, 2026
7867996
Feb 22, 2026

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE
ODE
GAIN
GAIN

Mar
Mar
Mar
Mar

06,
06,
06,
06,

2020
2022
2025
2027

U-1347
DP
DP
DP

U-1347
DP
DP
DP

U-1347
DP
DP
DP

U-1347
DP
DP
DP

U-1347
DP
DP
DP

U-1347
DP
DP
DP

DP
DP
DP
DP

U-1054
U-1054
U-1054
U-1054

DP
DP
DP
DP

U-1694
U-1694
U-1694
U-1694

NCE

Apr 15, 2020

DS DP U-1694
DS DP U-1694
DS DP U-1694

NCE

Apr 15, 2020

DS
DS
DS
DS

ADA 111 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
IVABRADINE HYDROCHLORIDE - CORLANOR
N 206143 002 7879842
Feb 22, 2026
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS DP U-1694

IVACAFTOR - KALYDECO
N 203188 001 7495103
8324242
8354427
8410274
8754224

May
Apr
Jul
Dec
Dec

20,
18,
06,
28,
28,

2027
2027
2026
2026
2026

DS DP

IVACAFTOR - KALYDECO
N 207925 001 7495103
8324242
8354427
8410274
8754224
8883206

May
Apr
Jul
Dec
Dec
Feb

20,
18,
06,
28,
28,
27,

2027
2027
2026
2026
2026
2033

DS DP

IVACAFTOR - KALYDECO
N 207925 002 7495103
8324242
8354427
8410274
8754224
8883206

May
Apr
Jul
Dec
Dec
Feb

20,
18,
06,
28,
28,
27,

2027
2027
2026
2026
2026
2033

DS DP

IVACAFTOR; LUMACAFTOR - ORKAMBI

N 206038 001 7495103
8324242
8410274
8507534
8653103
8716338
8741933
8754224
8846718
8993600

May
Apr
Dec
Sep
Dec
Nov
Nov
Dec
Dec
Dec

20,
18,
28,
20,
04,
08,
08,
28,
04,
11,

2027
2027
2026
2030
2028
2026
2026
2026
2028
2030

DS DP

IVERMECTIN - SKLICE
N 202736 001 6103248
8791153
8927595

May 22, 2018

Oct 12, 2027
Oct 12, 2027

DP
DP

IVERMECTIN - SOOLANTRA
N 206255 001 5952372
6133310
7550440
8080530
8093219
8415311
8470788
8815816
9089587

Sep
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Mar

18,
26,
22,
22,
22,
22,
22,
22,
13,

2018
2019
2024
2024
2024
2024
2024
2024
2034

IXABEPILONE - IXEMPRA KIT

N 022065 001 6670384
6670384
7022330
7125899
7312237
RE41393
RE41911

Jan
Jan
Jan
May
Aug
Feb
Sep

23,
23,
23,
26,
21,
08,
28,

2022
2022
2022
2018
2024
2022
2020

DP
DP
DP
DS DP

IXABEPILONE - IXEMPRA KIT

N 022065 002 6670384
6670384
7022330
7125899
7312237
RE41393

Jan
Jan
Jan
May
Aug
Feb

23,
23,
23,
26,
21,
08,

2022
2022
2022
2018
2024
2022

DP
DP
DP
DS DP

U-1311
U-1311

I-705
NCE
ODE

Dec 30, 2017

Jan 31, 2017
Jan 31, 2019

NCE
ODE

Jul 02, 2020

Jul 02, 2022

NP

Dec 19, 2017

DP
DS DP

U-1311
U-1311
DP
DS DP
DP

U-1311
U-1311
DP
DS DP
DP

U-1311
DP
DS DP
DP
DP U-1718
U-1717
DS DP
U-1717
DP

U-1782

DP
DP
DP
DP
DP
DP

U-1631
U-1631
U-1631
U-1631
U-1631
U-1631
U-1631
U-1631
U-1631

U-959
U-960
U-958
U-957
U-965
U-961
DS DP U-961

U-959
U-960
U-958
U-957
U-965
U-961

ADA 112 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

IXABEPILONE - IXEMPRA KIT

N 022065 002 RE41911

Sep 28, 2020

DS DP U-961

IXAZOMIB CITRATE - NINLARO

N 208462 001 7442830
7687662
8003819
8530694
8546608
8859504
8871745
9175017

Aug
Aug
Aug
Aug
Aug
Jun
Aug
Jun

06,
06,
06,
06,
12,
16,
06,
16,

2027
2027
2027
2027
2024
2029
2027
2029

DS
DS
DS
DS
DS
DS

IXAZOMIB CITRATE - NINLARO

N 208462 002 7442830
7687662
8003819
8530694
8546608
8859504
8871745
9175017

Aug
Aug
Aug
Aug
Aug
Jun
Aug
Jun

06,
06,
06,
06,
12,
16,
06,
16,

2027
2027
2027
2027
2024
2029
2027
2029

DS
DS
DS
DS
DS
DS

IXAZOMIB CITRATE - NINLARO

N 208462 003 7442830
7687662
8003819
8530694
8546608
8859504
8871745
9175017

Aug
Aug
Aug
Aug
Aug
Jun
Aug
Jun

06,
06,
06,
06,
12,
16,
06,
16,

2027
2027
2027
2027
2024
2029
2027
2029

DS
DS
DS
DS
DS
DS

KETOCONAZOLE - EXTINA
N 021738 001 7553835
8026238

Oct 19, 2018

Oct 19, 2018

DP U-245
DP U-1213

KETOCONAZOLE - XOLEGEL
N 021946 001 7179475
8232276
8735393

Dec 04, 2018

Nov 24, 2020
Dec 04, 2018

DP U-792
DP
DP

KETOROLAC TROMETHAMINE - ACULAR LS

N 021528 001 8008338
May
8207215
May
8377982
May
8377982*PED
Nov
8541463
May
8541463*PED
Nov
8648107
May
8906950
May
8946281
May
KETOROLAC TROMETHAMINE - SPRIX
N 022382 001 6333044

24,
28,
28,
28,
28,
28,
28,
28,
28,

DP U-1780
DP
DP U-1780
DP U-1780

DP U-1780
DP
DP U-1780
DP U-1780

NCE

Nov 20, 2020

NCE

Nov 20, 2020

NCE

Nov 20, 2020

NP

May 30, 2017

D-143
D-144

Aug 29, 2017

Aug 29, 2017

DP
U-1779
U-1778

DP U-1780
DP
DP U-1780
DP U-1780
DP
U-1779
U-1778

DS DP U-1181
U-1251
U-1363

Dec 25, 2018

DP U-1057

Mar 17, 2022

Mar 17, 2022

EXCLUSIVITY
EXPIRATION
DATE

U-1779
U-1778

U-1441
DP
U-1626
U-1662

DS DP
DP
DP
DP

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE - OMIDRIA

N 205388 001 8173707
Jul 30, 2023
U-1518
8586633
Jul 30, 2023
DP
9066856
Oct 23, 2033
DP
LACOSAMIDE - VIMPAT
N 022253 001 RE38551
RE38551

EXCLUSIVITY
CODE(S)

DP

2027
2024
2024
2024
2024
2024
2024
2024
2024

KETOROLAC TROMETHAMINE - ACUVAIL

N 022427 001 7842714
Aug 15, 2029
8512717
Mar 07, 2028
8992952
Aug 05, 2024
9192571
Mar 07, 2028

PATENT
DELIST
REQUESTED

DS DP U-1566
DS DP U-1567

ADA 113 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LACOSAMIDE - VIMPAT
N 022253 001

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-696

Aug 29, 2017

LACOSAMIDE - VIMPAT
N 022253 002 RE38551
RE38551

Mar 17, 2022

Mar 17, 2022

DS DP U-1566
DS DP U-1567

D-143
D-144
I-696

Aug 29, 2017

Aug 29, 2017
Aug 29, 2017

LACOSAMIDE - VIMPAT
N 022253 003 RE38551
RE38551

Mar 17, 2022

Mar 17, 2022

DS DP U-1566
DS DP U-1567

D-143
D-144
I-696

Aug 29, 2017

Aug 29, 2017
Aug 29, 2017

LACOSAMIDE - VIMPAT
N 022253 004 RE38551
RE38551

Mar 17, 2022

Mar 17, 2022

DS DP U-1566
DS DP U-1567

D-143
D-144
I-696

Aug 29, 2017

Aug 29, 2017
Aug 29, 2017

LACOSAMIDE - VIMPAT
N 022254 001 RE38551
RE38551

Mar 17, 2022

Mar 17, 2022

DS DP U-1565
DS DP U-1568

D-143
D-144
I-696

Aug 29, 2017

Aug 29, 2017
Aug 29, 2017

LACOSAMIDE - VIMPAT
N 022255 001 RE38551
RE38551

Mar 17, 2022

Mar 17, 2022

DS DP U-1566
DS DP U-1567

D-143
D-144
I-696

Aug 29, 2017

Aug 29, 2017
Aug 29, 2017

PC

Sep 01, 2015

LAMIVUDINE - LAMIVUDINE
A 203564 001
LAMIVUDINE - EPIVIR
N 020564 001 5905082
5905082*PED

May 18, 2016

Nov 18, 2016

DS DP

D-147

Mar 23, 2018

LAMIVUDINE - EPIVIR
N 020564 003 5905082
5905082*PED

May 18, 2016

Nov 18, 2016

DS DP

D-147

Mar 23, 2018

LAMIVUDINE - EPIVIR
N 020596 001 5905082
5905082*PED
6004968
6004968*PED

May
Nov
Mar
Sep

DS DP

D-147

Mar 23, 2018

LAMIVUDINE - EPIVIR-HBV
N 021003 001 5905082

May 18, 2016

LAMIVUDINE - EPIVIR-HBV
N 021004 001 6004968

Mar 20, 2018

LAMOTRIGINE - LAMOTRIGINE
A 200828 001

PC

Sep 28, 2015

LAMOTRIGINE - LAMOTRIGINE
A 200828 002

PC

Sep 28, 2015

LAMOTRIGINE - LAMOTRIGINE
A 200828 003

PC

Sep 28, 2015

18,
18,
20,
20,

2016
2016
2018
2018

LAMIVUDINE; RALTEGRAVIR POTASSIUM - DUTREBIS

N 206510 001 7169780
Oct 03, 2023
7217713
Oct 21, 2022
7435734
Oct 21, 2022
7754731
Mar 11, 2029
7820660
Apr 25, 2023
LAMIVUDINE; ZIDOVUDINE - COMBIVIR
N 020857 001 5905082
May 18, 2016

DP U-248

DS DP
U-1663
U-1663
DS DP U-1663
DS

DS DP U-248

ADA 114 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

LAMOTRIGINE - LAMOTRIGINE
A 200828 004

PC

Sep 28, 2015

LAMOTRIGINE - LAMICTAL
N 020241 001

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 002

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 003

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 004

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 005

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 006

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL CD
N 020764 001

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL CD
N 020764 002

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL CD
N 020764 003

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL CD
N 020764 004

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL XR
N 022115 001 8637512
9144547

Jun 14, 2028

Sep 22, 2023

DP
DP

LAMOTRIGINE - LAMICTAL XR
N 022115 002 8637512
9144547

Jun 14, 2028

Sep 22, 2023

DP
DP

LAMOTRIGINE - LAMICTAL XR
N 022115 003 8637512
9144547

Jun 14, 2028

Sep 22, 2023

DP
DP

LAMOTRIGINE - LAMICTAL XR
N 022115 004 8637512
9144547

Jun 14, 2028

Sep 22, 2023

DP
DP

LAMOTRIGINE - LAMICTAL XR
N 022115 005 8637512
9144547

Jun 14, 2028

Sep 22, 2023

DP
DP

LAMOTRIGINE - LAMICTAL XR
N 022115 006 8637512
9144547

Jun 14, 2028

Sep 22, 2023

DP
DP

LAMOTRIGINE - LAMICTAL ODT

N 022251 001 7919115
8840925

Jan 04, 2029

Jul 02, 2028

DS DP
DP U-1596

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL ODT

N 022251 002 7919115
8840925

Jan 04, 2029

Jul 02, 2028

DS DP
DP U-1596

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL ODT

N 022251 003 7919115
8840925

Jan 04, 2029

Jul 02, 2028

DS DP
DP U-1596

M-159

May 18, 2018

ADA 115 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

LAMOTRIGINE - LAMICTAL ODT

N 022251 004 7919115
8840925

PATENT
EXPIRATION
DATE
Jan 04, 2029
Jul 02, 2028

PATENT
CODES
DS DP
DP U-1596

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-159

May 18, 2018

LANREOTIDE ACETATE - SOMATULINE DEPOT

N 022074 001 5595760
Mar 08, 2020

DP U-831

I-701
ODE

Dec 19, 2017

Dec 16, 2021

LANREOTIDE ACETATE - SOMATULINE DEPOT

N 022074 002 5595760
Mar 08, 2020

DP U-831

I-701
ODE

Dec 19, 2017

Dec 16, 2021

LANREOTIDE ACETATE - SOMATULINE DEPOT

N 022074 003 5595760
Mar 08, 2020

DP U-831

I-701
ODE

Dec 19, 2017

Dec 16, 2021

LANSOPRAZOLE - PREVACID
N 021428 001 6328994
7399485
7431942
7875292

May
May
May
May

17,
26,
17,
17,

2019
2018
2019
2019

DP
DP
DP

LANSOPRAZOLE - PREVACID
N 021428 002 6328994
7399485
7431942
7875292

May
May
May
May

17,
26,
17,
17,

2019
2018
2019
2019

DP
DP
DP

LANSOPRAZOLE - PREVACID IV
N 021566 001 7396841

Aug 17, 2021

DP U-947

LANTHANUM CARBONATE - FOSRENOL

N 021468 001 5968976
7381428
7465465

Oct 26, 2018

Aug 26, 2024
Aug 26, 2024

DP U-613
U-890
DP

LANTHANUM CARBONATE - FOSRENOL

N 021468 002 5968976
7381428
7465465

Oct 26, 2018

Aug 26, 2024
Aug 26, 2024

DP U-613
U-890
DP

LANTHANUM CARBONATE - FOSRENOL

N 021468 003 5968976
7381428
7465465

Oct 26, 2018

Aug 26, 2024
Aug 26, 2024

DP U-613
U-890
DP

LANTHANUM CARBONATE - FOSRENOL

N 021468 004 5968976
7381428
7465465

Oct 26, 2018

Aug 26, 2024
Aug 26, 2024

DP U-613
U-890
DP

LANTHANUM CARBONATE - FOSRENOL

N 204734 001 5968976
7465465
8980327
9023397

Oct
Aug
Dec
Dec

26,
26,
01,
01,

2018
2024
2030
2030

DP U-1592
DP
DP
DP

LANTHANUM CARBONATE - FOSRENOL

N 204734 002 5968976
7465465
8980327
9023397

Oct
Aug
Dec
Dec

26,
26,
01,
01,

2018
2024
2030
2030

DP U-1592
DP
DP
DP

LAPATINIB DITOSYLATE - TYKERB

N 022059 001 6391874
6391874
6713485
6713485
6727256
6727256
6828320

Jul
Jul
Sep
Sep
Jan
Jan
Jul

11,
11,
29,
29,
08,
08,
11,

2017
2017
2020
2020
2019
2019
2017

DS
DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP

U-800
U-1429
U-800
U-1429
U-800
U-1429
U-800

ADA 116 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

LAPATINIB DITOSYLATE - TYKERB

N 022059 001 6828320
7157466
8513262
8821927

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

Jul
Nov
Jan
Sep

11,
19,
08,
18,

2017
2021
2019
2029

DS DP

DS DP

DS DP

U-1429

LEDIPASVIR; SOFOSBUVIR - HARVONI

N 205834 001 7964580
Mar
8088368
May
8273341
May
8334270
Mar
8580765
Mar
8618076
Dec
8633309
Mar
8735372
Mar
8822430
May
8841278
May
8889159
Mar
9085573
Mar

26,
12,
12,
21,
21,
11,
26,
21,
12,
12,
26,
21,

2029
2030
2030
2028
2028
2030
2029
2028
2030
2030
2029
2028

DS DP U-1470
DS DP
U-1470
DS DP U-1470
DS DP U-1470
DS DP U-1470
DS DP U-1470

U-1470

DS DP U-1470

DP U-1470

DP U-1470

DS DP U-1470

D-153
I-718
I-719
I-720
NCE
NPP

Nov
Nov
Nov
Nov
Oct
Nov

12,
12,
12,
12,
10,
12,

2018

2018

2018

2018

2019

2018

LENALIDOMIDE - REVLIMID

N 021880 001 5635517
6045501
6281230
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7468363
7855217
7968569
8204763
8288415
8315886
8404717
8530498
8589188
8626531
8648095
8741929
9056120
9101621
9101622

Oct
Aug
Jul
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Oct
Nov
Oct
Aug
Jul
Oct
Apr
May
Aug
Oct
May
Mar
Apr
May
May

04,
28,
24,
24,
23,
24,
28,
23,
23,
28,
24,
11,
27,
07,
24,
07,
28,
24,
23,
11,
15,
28,
23,
15,
08,
11,
15,
15,

2019
2018
2016
2016
2020
2016
2018
2020
2020
2018
2016
2023
2027
2023
2024
2023
2018
2016
2020
2023
2023
2018
2020
2023
2028
2023
2023
2023

DS

U-1211
U-1210
U-1212
U-1414
U-1210

DP U-1211

U-1210

U-1210

U-1210

U-1210

DP

U-1215

DS DP

U-1414

DS DP

U-1216

U-1249

DS DP

U-1249

U-1215

U-1216

U-1210

U-1210

U-1216

U-1414

U-1215

U-1216

U-1216

I-672
I-706
ODE
ODE

Jun
Feb
Jun
Feb

05,
17,
05,
17,

2016

2018

2020

2022

LENALIDOMIDE - REVLIMID

N 021880 002 5635517
6045501
6281230
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7468363
7855217
7968569
8204763
8288415
8315886

Oct
Aug
Jul
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Oct
Nov
Oct
Aug
Jul
Oct

04,
28,
24,
24,
23,
24,
28,
23,
23,
28,
24,
11,
27,
07,
24,
07,
28,
24,
23,

2019
2018
2016
2016
2020
2016
2018
2020
2020
2018
2016
2023
2027
2023
2024
2023
2018
2016
2020

DS

I-672
I-706
ODE
ODE

Jun
Feb
Jun
Feb

05,
17,
05,
17,

2016

2018

2020

2022

U-1211
U-1210
U-1212
U-1414
U-1210

DP U-1211

U-1210

U-1210

U-1210

U-1210

DP

U-1215

DS DP

U-1414

DS DP

U-1216

U-1249

DS DP

U-1249

ADA 117 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

LENALIDOMIDE - REVLIMID

N 021880 002 8404717
8530498
8589188
8626531
8648095
8741929
9056120
9101621
9101622

Apr
May
Aug
Oct
May
Mar
Apr
May
May

11,
15,
28,
23,
15,
08,
11,
15,
15,

2023
2023
2018
2020
2023
2028
2023
2023
2023

LENALIDOMIDE - REVLIMID

N 021880 003 5635517
6045501
6281230
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7468363
7855217
7968569
8204763
8288415
8315886
8404717
8530498
8589188
8626531
8648095
8741929
9056120
9101621
9101622

Oct
Aug
Jul
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Oct
Nov
Oct
Aug
Jul
Oct
Apr
May
Aug
Oct
May
Mar
Apr
May
May

04,
28,
24,
24,
23,
24,
28,
23,
23,
28,
24,
11,
27,
07,
24,
07,
28,
24,
23,
11,
15,
28,
23,
15,
08,
11,
15,
15,

2019
2018
2016
2016
2020
2016
2018
2020
2020
2018
2016
2023
2027
2023
2024
2023
2018
2016
2020
2023
2023
2018
2020
2023
2028
2023
2023
2023

DS

U-1211
U-1210
U-1212
U-1414
U-1210

DP U-1211

U-1210

U-1210

U-1210

U-1210

DP

U-1215

DS DP

U-1414

DS DP

U-1216

U-1249

DS DP

U-1249

U-1215

U-1216

U-1210

U-1210

U-1216

U-1414

U-1215

U-1216

U-1216

I-672
I-706
ODE
ODE

Jun
Feb
Jun
Feb

05,
17,
05,
17,

2016

2018

2020

2022

LENALIDOMIDE - REVLIMID

N 021880 004 5635517
6045501
6281230
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7468363
7855217
7968569
8204763
8288415
8315886
8404717
8530498
8589188
8626531
8648095
8741929
9056120
9101621

Oct
Aug
Jul
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Oct
Nov
Oct
Aug
Jul
Oct
Apr
May
Aug
Oct
May
Mar
Apr
May

04,
28,
24,
24,
23,
24,
28,
23,
23,
28,
24,
11,
27,
07,
24,
07,
28,
24,
23,
11,
15,
28,
23,
15,
08,
11,
15,

2019
2018
2016
2016
2020
2016
2018
2020
2020
2018
2016
2023
2027
2023
2024
2023
2018
2016
2020
2023
2023
2018
2020
2023
2028
2023
2023

DS

I-672
I-706
ODE
ODE

Jun
Feb
Jun
Feb

05,
17,
05,
17,

2016

2018

2020

2022

U-1215

U-1216

U-1210

U-1210

U-1216

U-1414

U-1215

U-1216

U-1216

U-1211
U-1210
U-1212
U-1414
U-1210

DP U-1211

U-1210

U-1210

U-1210

U-1210

DP

U-1215

DS DP

U-1414

DS DP

U-1216

U-1249

DS DP

U-1249

U-1215

U-1216

U-1210

U-1210

U-1216

U-1414

U-1215

U-1216

ADA 118 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

LENALIDOMIDE - REVLIMID

N 021880 004 9101622

May 15, 2023

LENALIDOMIDE - REVLIMID

N 021880 005 5635517
6045501
6281230
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7468363
7855217
7968569
8204763
8288415
8315886
8404717
8530498
8589188
8626531
8648095
8741929
9056120
9101621
9101622

Oct
Aug
Jul
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Oct
Nov
Oct
Aug
Jul
Oct
Apr
May
Aug
Oct
May
Mar
Apr
May
May

04,
28,
24,
24,
23,
24,
28,
23,
23,
28,
24,
11,
27,
07,
24,
07,
28,
24,
23,
11,
15,
28,
23,
15,
08,
11,
15,
15,

2019
2018
2016
2016
2020
2016
2018
2020
2020
2018
2016
2023
2027
2023
2024
2023
2018
2016
2020
2023
2023
2018
2020
2023
2028
2023
2023
2023

DS

U-1211
U-1210
U-1212
U-1414
U-1210

DP U-1211

U-1210

U-1210

U-1210

U-1210

DP

U-1215

DS DP

U-1414

DS DP

U-1216

U-1249

DS DP

U-1249

U-1215

U-1216

U-1210

U-1210

U-1216

U-1414

U-1215

U-1216

U-1216

I-672
I-706
ODE
ODE

Jun
Feb
Jun
Feb

05,
17,
05,
17,

2016

2018

2020

2022

LENALIDOMIDE - REVLIMID

N 021880 006 5635517
6045501
6281230
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7468363
7855217
7968569
8204763
8288415
8315886
8404717
8530498
8589188
8626531
8648095
8741929
9056120
9101621
9101622

Oct
Aug
Jul
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Oct
Nov
Oct
Aug
Jul
Oct
Apr
May
Aug
Oct
May
Mar
Apr
May
May

04,
28,
24,
24,
23,
24,
28,
23,
23,
28,
24,
11,
27,
07,
24,
07,
28,
24,
23,
11,
15,
28,
23,
15,
08,
11,
15,
15,

2019
2018
2016
2016
2020
2016
2018
2020
2020
2018
2016
2023
2027
2023
2024
2023
2018
2016
2020
2023
2023
2018
2020
2023
2028
2023
2023
2023

DS

U-1211
U-1210
U-1212
U-1414
U-1210
DP U-1211

U-1210

U-1210

U-1210

U-1210

DP

U-1215

DS DP

U-1414

DS DP

U-1216

U-1249

DS DP

U-1249

U-1215

U-1216

U-1210

U-1210

U-1216

U-1414

U-1215

U-1216

U-1216

I-672
I-706
NS
ODE
ODE

Jun
Feb
Jun
Jun
Feb

05,
17,
05,
05,
17,

2016

2018

2016

2020

2022

LENVATINIB MESYLATE - LENVIMA

N 206947 001 7253286
7612208
9006256

Oct 19, 2021

Sep 19, 2026
Jul 27, 2027

DS DP
DS DP

NCE
ODE

Feb 13, 2020

Feb 13, 2022

U-1216

U-1695

ADA 119 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

LENVATINIB MESYLATE - LENVIMA

N 206947 002 7253286
7612208
9006256

PATENT
EXPIRATION
DATE
Oct 19, 2021
Sep 19, 2026
Jul 27, 2027

PATENT
CODES
DS DP
DS DP

LEUPROLIDE ACETATE - LUPRON DEPOT

N 019732 001 6036976
Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 002 6036976
Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 005 6036976
Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 006 6036976
Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 007 6036976
Dec 13, 2016

DP

LEUPROLIDE ACETATE - LUPRON DEPOT-PED

N 020263 008 6036976
Dec 13, 2016

DP

LEUPROLIDE ACETATE - LUPRON DEPOT

N 020517 001 6036976
Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
N 020517 002 6036976
Dec 13, 2016

13,
13,
28,
05,

2016
2019
2022
2031

DP
DP
DP
DP U-1666

LEUPROLIDE ACETATE - LUPRON DEPOT

N 020708 001 6036976
Dec 13, 2016
LEUPROLIDE ACETATE - VIADUR
N 021088 001 5728396
5932547
5985305
6113938
6124261
6132420
6156331
6235712
6375978
6395292

Jan
Jun
Jan
Jul
Jun
Jan
Jan
Jun
Dec
Jan

2017
2017
2017
2018
2017
2017
2017
2017
2018
2017

U-316

LEUPROLIDE ACETATE - ELIGARD

N 021343 001 6565874
6626870
6773714

Oct 28, 2018

Mar 27, 2020
Oct 28, 2018

DP U-801
DP
DP U-801

LEUPROLIDE ACETATE - ELIGARD

N 021379 001 6565874
6626870
6773714

Oct 28, 2018

Mar 27, 2020
Oct 28, 2018

DP U-801
DP
DP U-801

LEUPROLIDE ACETATE - ELIGARD

N 021488 001 6565874
6626870
6773714

Oct 28, 2018

Mar 27, 2020
Oct 28, 2018

DP U-801
DP
DP U-801

30,
13,
30,
24,
13,
30,
30,
13,
17,
30,

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE
ODE

Feb 13, 2020

Feb 13, 2022

NCE

Dec 22, 2020

U-1695

LESINURAD - ZURAMPIC
N 207988 001

LEUPROLIDE ACETATE - LUPRON DEPOT

N 020517 003 6036976
Dec
7429559
Jan
8815801
Jun
8921326
Feb

PATENT
DELIST
REQUESTED

ADA 120 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

LEUPROLIDE ACETATE - ELIGARD

N 021731 001 6565874
6626870
6773714

PATENT
EXPIRATION
DATE

PATENT
CODES

Oct 28, 2018

Mar 27, 2020
Oct 28, 2018

DP U-621
DP
U-621

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE - LUPANETA PACK

N 203696 001 6036976
Dec 13, 2016
DP
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE - LUPANETA PACK
N 203696 002 6036976
Dec 13, 2016
DP
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 001 6451289
Mar 21, 2021

M-151

Jan 22, 2018

LEVALBUTEROL HYDROCHLORIDE - XOPENEX

N 020837 002 6451289
Mar 21, 2021

M-151

Jan 22, 2018

LEVALBUTEROL HYDROCHLORIDE - XOPENEX

N 020837 003 6451289
Mar 21, 2021

M-151

Jan 22, 2018

M-151

Jan 22, 2018

M-156

Mar 12, 2018

LEVALBUTEROL HYDROCHLORIDE - XOPENEX

N 020837 004 6451289
Mar 21, 2021
LEVALBUTEROL TARTRATE - XOPENEX HFA
N 021730 001 5836299
Nov 17, 2015
7256310
Oct 08, 2024
8765153
Dec 08, 2023

DP

DP
DS DP U-636
DP

LEVETIRACETAM - KEPPRA
N 021035 001 8802142
8802142*PED

Jun 07, 2031

Dec 07, 2031

DP

LEVETIRACETAM - KEPPRA
N 021035 002 8802142
8802142*PED

Jun 07, 2031

Dec 07, 2031

DP

LEVETIRACETAM - KEPPRA
N 021035 003 8802142
8802142*PED

Jun 07, 2031

Dec 07, 2031

DP

LEVETIRACETAM - KEPPRA
N 021035 004 8802142
8802142*PED

Jun 07, 2031

Dec 07, 2031

DP

LEVETIRACETAM - KEPPRA XR
N 022285 001 7858122

Sep 17, 2028

DP

LEVETIRACETAM - KEPPRA XR
N 022285 002 7858122

Sep 17, 2028

DP

LEVETIRACETAM - SPRITAM
N 207958 001 6471992

Feb 20, 2018

DP

LEVETIRACETAM - SPRITAM
N 207958 002 6471992

Feb 20, 2018

DP

LEVETIRACETAM - SPRITAM
N 207958 003 6471992

Feb 20, 2018

DP

LEVETIRACETAM - SPRITAM
N 207958 004 6471992

Feb 20, 2018

DP

LEVOCARNITINE - CARNITOR
N 020182 001 6335369
6429230
6696493

Jan 18, 2021

Jan 18, 2021
Jan 18, 2021

LEVOFLOXACIN - LEVAQUIN
N 021721 001 6806256

Feb 26, 2022

U-433
U-433
U-433

DP

ADA 121 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
LEVOLEUCOVORIN CALCIUM - LEVOLEUCOVORIN CALCIUM
A 203563 001
APPL/PROD
NO

PATENT NO

PATENT
CODES

LEVOLEUCOVORIN CALCIUM - LEVOLEUCOVORIN CALCIUM

A 203563 002

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

PC

Oct 20, 2015

PC

Oct 20, 2015

LEVOLEUCOVORIN CALCIUM - FUSILEV

N 020140 001 6500829
Mar 07, 2022

DS DP

ODE

Apr 29, 2018

LEVOLEUCOVORIN CALCIUM - FUSILEV

N 020140 002 6500829
Mar 07, 2022

DS DP

ODE

Apr 29, 2018

LEVOLEUCOVORIN CALCIUM - FUSILEV

N 020140 003 6500829
Mar 07, 2022

DS DP

ODE

Apr 29, 2018

NCE*

Jul 25, 2018

NCE*

Jul 25, 2018

NCE*

Jul 25, 2018

NCE*

Jul 25, 2018

RTO*
RTO**

Apr 30, 2016

Apr 30, 2016

NP

Jan 09, 2016

NP

Feb 26, 2018

LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA

N 204168 001 8481598
Mar 02, 2031
8865937
May 23, 2032
RE43879
Jun 03, 2023
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
N 204168 002 8481598
Mar 02, 2031
8865937
May 23, 2032
RE43879
Jun 03, 2023
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
N 204168 003 8481598
Mar 02, 2031
8865937
May 23, 2032
RE43879
Jun 03, 2023
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
N 204168 004 8481598
Mar 02, 2031
8865937
May 23, 2032
RE43879
Jun 03, 2023
LEVONORGESTREL - MIRENA
N 021225 001 5785053

Dec 05, 2015

U-839
DS DP
U-839

U-839
DS DP
U-839

U-839
DS DP
U-839

U-839
DS DP
U-839

DP

LEVONORGESTREL - PLAN B ONE-STEP

N 021998 001

LEVONORGESTREL - SKYLA
N 203159 001 5785053
7252839

Dec 05, 2015

Nov 13, 2023

DP
DP

LEVONORGESTREL - LILETTA
N 206229 001
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 001 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 002 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 003 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 004 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

U-759

U-759

U-759

U-759

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 122 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 005 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 006 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 007 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 008 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 009 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 010 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 011 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N 021301 012 6555581
7067148
7101569

Feb 15, 2022

Feb 15, 2022
Oct 02, 2023

DP

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 001 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 002 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 003 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 004 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 005 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 006 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 007 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 008 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 009 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 010 6399101

Mar 30, 2020

U-759

U-759

U-759

U-759

U-759

U-759

U-759

U-759

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 123 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LEVOTHYROXINE SODIUM - LEVO-T

N 021342 011 6399101

Mar 30, 2020

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 002 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 003 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 004 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 005 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 006 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 007 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 008 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 009 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 021924 010 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N 022121 001 7723390

Mar 14, 2024

DP

LEVOTHYROXINE SODIUM - LEVOTHYROXINE

N 202231 001 9006289
Oct
9168238
Aug
9168239
Aug

SODIUM
03, 2032
29, 2032
29, 2032

DP
DP
DP

LEVOTHYROXINE SODIUM - LEVOTHYROXINE

N 202231 002 9006289
Oct
9168238
Aug
9168239
Aug

SODIUM
03, 2032
29, 2032
29, 2032

DP
DP
DP

LEVOTHYROXINE SODIUM - LEVOTHYROXINE

N 202231 003 9006289
Oct
9168238
Aug
9168239
Aug

SODIUM
03, 2032
29, 2032
29, 2032

DP
DP
DP

LIDOCAINE - LIDODERM
N 020612 001 5827529

Oct 27, 2015

LIDOCAINE HYDROCHLORIDE - ZINGO

N 022114 001 5899880
6004286
6881200
8540665

May
Mar
Jun
Oct

LIDOCAINE HYDROCHLORIDE - AKTEN

N 022221 001 8759401

Jul 24, 2026

DP U-1523

LIDOCAINE; PRILOCAINE - ORAQIX

N 021451 001 6031007

Apr 01, 2017

DP U-553

LIDOCAINE; TETRACAINE - SYNERA

N 021623 001 5658583
5919479
6306431
6465006
6465709
6546281
6780426

Jul
Jul
Jul
Jul
Jul
Jul
Jul

DP
DP
DP
DP
DP
DP
DP

04,
17,
11,
22,

28,
28,
28,
28,
07,
28,
28,

2016
2017
2016
2029

2015
2015
2015
2015
2020
2015
2015

U-486

DP
DP
DP
U-1438

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 124 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

Jul
Jul
Jul
Jul
Jul
Jul
Jul

2015
2015
2015
2015
2020
2015
2015

DP
DP
DP
DP
DP
DP
DP

LIDOCAINE; TETRACAINE - PLIAGLIS

N 021717 001 5919479
Jul 28, 2015
6528086
Sep 28, 2019

DP
DP

PATENT NO

LIDOCAINE; TETRACAINE - SYNERA

N 021623 001 5658583
5919479
6306431
6465006
6465709
6546281
6780426

28,
28,
28,
28,
07,
28,
28,

LINACLOTIDE - LINZESS
N 202811 001 7304036
7304036
7371727
7704947
7745409
8080526
8110553
8748573
8748573
8802628
8933030

Aug
Aug
Jan
Jan
Jan
Jan
Jan
Jun
Jun
Jul
Feb

30,
30,
28,
28,
28,
28,
28,
20,
20,
24,
17,

2026
2026
2024
2024
2024
2024
2024
2031
2031
2031
2031

DS
DS
DS
DS
DS
DS

LINACLOTIDE - LINZESS
N 202811 002 7304036
7304036
7371727
7704947
7745409
8080526
8110553
8748573
8748573
8802628
8933030

Aug
Aug
Jan
Jan
Jan
Jan
Jan
Jun
Jun
Jul
Feb

30,
30,
28,
28,
28,
28,
28,
20,
20,
24,
17,

2026
2026
2024
2024
2024
2024
2024
2031
2031
2031
2031

DS
DS
DS
DS
DS
DS

LINAGLIPTIN - TRADJENTA
N 201280 001 6303661
6303661
6890898
6890898
7078381
7078381
7407955
7459428
7459428
8119648
8119648
8178541
8178541
8178541
8178541
8673927
8846695
8853156
8883805
9173859
9173859

Apr
Apr
Feb
Feb
Feb
Feb
Aug
Feb
Feb
Aug
Aug
Aug
Aug
Aug
Aug
May
Jun
Mar
Nov
May
May

24,
24,
02,
02,
02,
02,
12,
02,
02,
12,
12,
12,
12,
12,
12,
04,
04,
05,
26,
04,
04,

2017
2017
2019
2019
2019
2019
2023
2019
2019
2023
2023
2023
2023
2023
2023
2027
2030
2031
2025
2027
2027

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

N 201281 001 6303661
Apr
6890898
Feb
7078381
Feb
7407955
Aug
7459428
Feb
8119648
Aug
8178541
Aug

DP U-1278
DP U-1516

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Aug 30, 2017

NCE

Aug 30, 2017

M-118
M-121
NCE

Aug 13, 2015

Aug 13, 2015
May 02, 2016

M-146
NCE

Jul 30, 2017

May 02, 2016

DP
DP
DP
U-1278
U-1515
U-1516
DP
DP

DP U-1278
DP U-1516
DP
DP
DP
U-1278
U-1515
U-1516
DP
DP

U-774
U-1270
U-493
U-1270
U-493
U-1270
DS DP
U-493
U-1270
U-774
U-1270
U-775
U-1244
U-1245
U-1270
U-1503
U-1503
U-1642
DP
DP U-1503
DP U-1768

- JENTADUETO
24, 2017
U-802
02, 2019
U-1039
02, 2019
U-1039
12, 2023
DS DP

02, 2019
U-1039

12, 2023
U-802

12, 2023
DP U-775

ADA 125 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO
N 201281 001 8673927
May 04, 2027
8846695
Jun 04, 2030
8883805
Nov 26, 2025
9155705
May 21, 2030
9173859
May 04, 2027
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1503
U-1503
DP
DP
DP U-1503

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

N 201281 002 6303661
Apr
6890898
Feb
7078381
Feb
7407955
Aug
7459428
Feb
8119648
Aug
8178541
Aug
8673927
May
8846695
Jun
8883805
Nov
9155705
May
9173859
May

- JENTADUETO
24, 2017
02, 2019
02, 2019
12, 2023
DS
02, 2019
12, 2023
12, 2023
04, 2027
04, 2030
26, 2025
21, 2030
04, 2027

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

N 201281 003 6303661
Apr
6890898
Feb
7078381
Feb
7407955
Aug
7459428
Feb
8119648
Aug
8178541
Aug
8673927
May
8846695
Jun
8883805
Nov
9155705
May
9173859
May

- JENTADUETO
24, 2017
02, 2019
02, 2019
12, 2023
DS
02, 2019
12, 2023
12, 2023
04, 2027
04, 2030
26, 2025
21, 2030
04, 2027

M-146
NCE

Jul 30, 2017

May 02, 2016

M-146
NCE

Jul 30, 2017

May 02, 2016

LINEZOLID - LINEZOLID
A 078061 001

PC

Dec 19, 2015

LINEZOLID - LINEZOLID
A 200222 001

PC

Jul 04, 2015

LINEZOLID - ZYVOX
N 021130 001 6514529
6559305

Mar 15, 2021

Jan 29, 2021

DS

LINEZOLID - ZYVOX
N 021130 002 6514529
6559305

Mar 15, 2021

Jan 29, 2021

DS

LINEZOLID - ZYVOX
N 021131 001 6559305

Jan 29, 2021

DS

LINEZOLID - ZYVOX
N 021131 002 6559305
6559305*PED

Jan 29, 2021

Jul 29, 2021

DS

LINEZOLID - ZYVOX
N 021131 003 6559305
6559305*PED

Jan 29, 2021

Jul 29, 2021

DS

LINEZOLID - ZYVOX
N 021132 001 6559305

Jan 29, 2021

DS

LIRAGLUTIDE RECOMBINANT - VICTOZA

N 022341 001 6004297
Jan
6268343
Aug
6458924
Aug
7235627
Aug
8114833
Aug
8846618
Jun

28,
22,
22,
22,
13,
27,

2019
2022
2017
2017
2025
2022

U-802
U-1039
U-1039
DP
U-1039
U-802
DP U-775
U-1503
U-1503
DP
DP
DP U-1503

U-802
U-1039
U-1039
DP
U-1039
U-802
DP U-775
U-1503
U-1503
DP
DP
DP U-1503

DP

DP

DP

DS DP U-968

DS DP U-968

DS DP

DP

DP

ADA 126 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

LIRAGLUTIDE RECOMBINANT - VICTOZA

N 022341 001 RE41956
Jan 21, 2021
RE43834
Jan 28, 2019
LIRAGLUTIDE RECOMBINANT - SAXENDA
N 206321 001 6268343
Aug
6458924
Aug
6899699
Jan
7235627
Aug
7686786
Aug
8114833
Aug
8672898
Jan
8684969
Oct
8846618
Jun
8920383
Jul
9108002
Jan
9132239
Feb

22,
22,
01,
22,
03,
13,
02,
20,
27,
17,
26,
01,

2022
2017
2022
2017
2026
2025
2022
2025
2022
2026
2026
2032

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 001 7105486
Feb 24,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7662788
Feb 24,
7671030
Feb 24,
7671031
Feb 24,
7674774
Feb 24,
7678770
Feb 24,
7678771
Feb 24,
7687466
Feb 24,
7687467
Feb 24,
7700561
Feb 24,
7713936
Feb 24,
7718619
Feb 24,
7723305
Feb 24,

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 002 7105486
Feb 24,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7662788
Feb 24,
7671030
Feb 24,
7671031
Feb 24,
7674774
Feb 24,
7678770
Feb 24,
7678771
Feb 24,
7687466
Feb 24,
7687467
Feb 24,
7700561
Feb 24,
7713936
Feb 24,
7718619
Feb 24,
7723305
Feb 24,

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 003 7105486
Feb 24,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7662788
Feb 24,
7671030
Feb 24,
7671031
Feb 24,
7674774
Feb 24,
7678770
Feb 24,

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP

DS DP U-1255
DS DP U-1255
DP
DS DP
DP
DP
DP
DP
DP
DP
DP
DP

U-727

NP

Jan 25, 2017

I-703

Jan 30, 2018

I-703

Jan 30, 2018

I-703

Jan 30, 2018

DP
DS
DS DP U-727
U-1034
DS
U-727
DP U-727
U-727
DP U-842
U-842
DP U-842
DP
DP U-842
DP
U-727
DP U-842
DP U-842

U-727
DP
DS
DS DP U-727
U-1034
DS
U-727
DP U-727
U-727
DP U-842
U-842
DP U-842
DP
DP U-842
DP
U-727
DP U-842
DP U-842

U-727
DP
DS
DS DP U-727
U-1034
DS
U-727
DP U-727
U-727
DP U-842
U-842

ADA 127 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 003 7678771
Feb 24, 2023
7687466
Feb 24, 2023
7687467
Feb 24, 2023
7700561
Feb 24, 2023
7713936
Feb 24, 2023
7718619
Feb 24, 2023
7723305
Feb 24, 2023
PATENT NO

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 004 7105486
Feb 24,
7105486
Feb 24,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7662788
Feb 24,
7671030
Feb 24,
7671031
Feb 24,
7674774
Feb 24,
7678770
Feb 24,
7678771
Feb 24,
7687466
Feb 24,
7687467
Feb 24,
7700561
Feb 24,
7713936
Feb 24,
7718619
Feb 24,
7723305
Feb 24,

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 005 7105486
Feb 24,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7662788
Feb 24,
7671030
Feb 24,
7671031
Feb 24,
7674774
Feb 24,
7678770
Feb 24,
7678771
Feb 24,
7687466
Feb 24,
7687467
Feb 24,
7700561
Feb 24,
7713936
Feb 24,
7718619
Feb 24,
7723305
Feb 24,

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 006 7105486
Feb 24,
7105486
Feb 24,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7662788
Feb 24,
7671030
Feb 24,
7671031
Feb 24,
7674774
Feb 24,
7678770
Feb 24,
7678771
Feb 24,
7687466
Feb 24,
7687467
Feb 24,
7700561
Feb 24,
7713936
Feb 24,
7718619
Feb 24,
7723305
Feb 24,

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP U-842

DP

DP U-842

DP

U-727

DP U-842

DP U-842

U-727
U-842

I-703

Jan 30, 2018

I-703

Jan 30, 2018

I-703

Jan 30, 2018

DP

DS

DS DP U-727

U-1034

DS

U-727

DP U-727

U-727

DP U-842

U-842

DP U-842

DP

DP U-842

DP

U-727

DP U-842

DP U-842

U-842
DP

DS

DS DP U-727

U-1034

DS

U-727

DP U-727

U-727

DP U-842

U-842

DP U-842

DP

DP U-842

DP

U-727

DP U-842

DP U-842

U-727
U-842

DP

DS

DS DP U-727

U-1034

DS

U-727

DP U-727

U-727

DP U-842

U-842

DP U-842

DP

DP U-842

DP

U-727

DP U-842

DP U-842

ADA 128 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT

EXPIRATION

DATE

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 006 7105486
Feb 24, 2023

7105486
Feb 24, 2023

7223735
Feb 24, 2023

7655630
Feb 24, 2023

7659253
Feb 24, 2023

7659254
Feb 24, 2023

7662787
Feb 24, 2023

7662788
Feb 24, 2023

7671030
Feb 24, 2023

7671031
Feb 24, 2023

7674774
Feb 24, 2023

7678770
Feb 24, 2023

7678771
Feb 24, 2023

7687466
Feb 24, 2023

7687467
Feb 24, 2023

7700561
Feb 24, 2023

7713936
Feb 24, 2023

7718619
Feb 24, 2023

7723305
Feb 24, 2023

DP

DS

DS DP U-727

U-1034

DS

U-727

DP U-727

U-727

DP U-842

U-842

DP U-842

DP

DP U-842

DP

U-727

DP U-842

DP U-842

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N 021977 007 7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7662788
Feb 24,
7671030
Feb 24,
7671031
Feb 24,
7674774
Feb 24,
7678770
Feb 24,
7678771
Feb 24,
7687466
Feb 24,
7687467
Feb 24,
7700561
Feb 24,
7713936
Feb 24,
7718619
Feb 24,

2023

2023

2023

2023

2023

2023

2023

2023

2023

2023

2023

2023

2023

2023

2023

2023

LOMITAPIDE MESYLATE - JUXTAPID

N 203858 001 5712279
6492365
7932268
8618135

Feb
Dec
Aug
Mar

21,
10,
19,
07,

LOMITAPIDE MESYLATE - JUXTAPID

N 203858 002 5712279
6492365
7932268
8618135

Feb
Dec
Aug
Mar

LOMITAPIDE MESYLATE - JUXTAPID

N 203858 003 5712279
6492365
7932268
8618135

PATENT NO

PATENT
CODES
U-727

U-842

PATENT

DELIST

REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

I-703

Jan 30, 2018

DP

DS

DS DP U-727

U-1034

DS

U-727

DP U-727

U-727

DP U-842

U-842

DP

DP

DP U-842

DP

U-727

DP U-842

I-703

Jan 30, 2018

2016

2019

2027

2025

DS

U-1317

U-1318

U-1316

U-1316

NCE
ODE

Dec 21, 2017

Dec 21, 2019

21,
10,
19,
07,

2016

2019

2027

2025

DS

U-1317

U-1318

U-1316

U-1316

NCE
ODE

Dec 21, 2017

Dec 21, 2019

Feb
Dec
Aug
Mar

21,
10,
19,
07,

2016

2019

2027

2025

DS

U-1317

U-1318

U-1316

U-1316

NCE
ODE

Dec 21, 2017

Dec 21, 2019

LOMITAPIDE MESYLATE - JUXTAPID

N 203858 004 5712279
6492365
7932268
8618135

Feb
Dec
Aug
Mar

21,
10,
19,
07,

2016

2019

2027

2025

DS

U-1317

U-1318

U-1316

U-1316

NCE
ODE

Dec 21, 2017

Dec 21, 2019

LOMITAPIDE MESYLATE - JUXTAPID

N 203858 005 5712279
6492365
7932268
8618135

Feb
Dec
Aug
Mar

21,
10,
19,
07,

2016
2019
2027
2025

DS

U-1317
U-1318
U-1316
U-1316

NCE
ODE

Dec 21, 2017

Dec 21, 2019

ADA 129 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

LOMITAPIDE MESYLATE - JUXTAPID

N 203858 006 5712279
6492365
7932268
8618135

PATENT
EXPIRATION
DATE
Feb
Dec
Aug
Mar

21,
10,
19,
07,

2016
2019
2027
2025

LOPERAMIDE HYDROCHLORIDE - IMODIUM A-D EZ CHEWS

N 020448 001 6814978
Aug 26, 2021

PATENT
CODES
DS

PATENT
DELIST
REQUESTED

U-1317
U-1318
U-1316

U-1316

DP

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF

N 021140 001 6103260
Jul 17, 2017
DP

LOPINAVIR; RITONAVIR - KALETRA

N 021226 001 5914332
6037157
6232333
6284767
6284767
6458818
6521651
6703403
7141593
7432294

Dec
Jun
Nov
Feb
Feb
Nov
Nov
Jun
May
May

13,
26,
07,
15,
15,
07,
07,
26,
22,
22,

2015
2016
2017

2016
2016
2017

2017
2016
2020
2020

LOPINAVIR; RITONAVIR - KALETRA

N 021251 001 5914332
5914332
6037157
6037157
6284767
6284767
6703403
6703403
6911214
8501219

Dec
Dec
Jun
Jun
Feb
Feb
Jun
Jun
Nov
Nov

13,
13,
26,
26,
15,
15,
26,
26,
28,
28,

2015
2015
2016
2016
2016
2016
2016
2016
2021
2021

DS DP U-351

DS DP U-895

U-346

U-895

DP U-401

DP U-895

U-257

U-895

DP U-895

DP

LOPINAVIR; RITONAVIR - KALETRA

N 021906 001 5914332
6037157
6284767
6703403
7148359
7364752
8025899
8025899*PED
8268349
8309613
8377952
8377952*PED
8399015
8399015*PED
8470347
8470347*PED
8691878
8691878*PED

Dec
Jun
Feb
Jun
Jul
Nov
Dec
Jun
Aug
Dec
Oct
Apr
Aug
Feb
Sep
Mar
Aug
Feb

13,
26,
15,
26,
19,
10,
14,
14,
25,
24,
22,
22,
25,
25,
17,
17,
25,
25,

2015
2016
2016
2016
2019
2020
2027
2028

2024
2024
2027
2028

2024
2025

2026
2027

2024
2025

DS DP U-688

U-688

DP U-688

U-688

DP

DP U-688

DP

LOPINAVIR; RITONAVIR - KALETRA

N 021906 002 5914332
6037157
6284767
6703403
7148359
7364752
8025899
8025899*PED
8268349
8309613
8377952
8377952*PED
8399015

Dec
Jun
Feb
Jun
Jul
Nov
Dec
Jun
Aug
Dec
Oct
Apr
Aug

13,
26,
15,
26,
19,
10,
14,
14,
25,
24,
22,
22,
25,

2015
2016
2016
2016
2019
2020
2027
2028

2024
2024
2027
2028

2024

DS DP U-688

U-688

DP U-688

U-688

DP

DP U-688

DP

U-351

U-346

DP U-401

DP U-688

DP

U-257

DP

DP

DP

U-688

U-1372

DP

DP

U-1513

DP

U-688

U-1372

DP

EXCLUSIVITY
CODE(S)
NCE
ODE

EXCLUSIVITY

EXPIRATION

DATE

Dec 21, 2017

Dec 21, 2019

ADA 130 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

LOPINAVIR; RITONAVIR - KALETRA

N 021906 002 8399015*PED
8470347
8470347*PED
8691878
8691878*PED

Feb
Sep
Mar
Aug
Feb

LORATADINE - CLARITIN

N 020641 002 6132758

Jun 01, 2018

LORCASERIN HYDROCHLORIDE - BELVIQ

N 022529 001 6953787
Apr
6953787
Apr
6953787
Apr
6953787
Apr
7514422
Apr
7514422
Apr
7514422
Apr
7514422
Apr
7977329
Apr
7977329
Apr
7977329
Apr
7977329
Apr
8168624
Apr
8207158
Apr
8207158
Apr
8207158
Apr
8207158
Apr
8273734
Apr
8273734
Apr
8367657
Apr
8367657
Apr
8367657
Apr
8367657
Apr
8546379
Apr
8546379
Apr
8546379
Apr
8546379
Apr
8575149
Apr
8697686
Dec
8946207
Jun
8980881
Dec
8980881
Dec
8980881
Dec
8980881
Dec
8999970
Feb
8999970
Feb
8999970
Feb
9169213
Dec
9169213
Dec
9169213
Dec
9169213
Dec

25,
17,
17,
25,
25,

10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
18,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
10,
20,
16,
20,
20,
20,
20,
07,
07,
07,
06,
06,
06,
06,

PATENT
CODES

2025

2026
2027

2024
2025

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2029
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2025
2024
2025
2025
2025
2025
2033
2033
2033
2032
2032
2032
2032

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

U-1513

DP

DS
DS
DS
DS

DP
DP
DP
DP

DS
DS
DS
DS
DS

DP
DP
DP
DP
DP

DS
DS
DS
DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP
DP

U-1252
U-1253

U-1254

U-1255

U-1252

U-1253

U-1254

U-1255

U-1252

U-1253

U-1254

U-1255

NCE

Jun 27, 2017

NDF

Sep 28, 2015

U-1252

U-1253

U-1254

U-1255

U-1254

U-1255

U-1252

U-1253

U-1254

U-1255

U-1252

U-1253

U-1254

U-1255

U-1452

DS DP

DP

U-1252

U-1253

U-1254

U-1255

U-1688

U-1689

U-1692

U-1762

U-1763

U-1764

U-1765

LOTEPREDNOL ETABONATE - LOTEMAX

N 202872 001 5800807
Jan 29, 2017

DP

LOVASTATIN - ALTOPREV

N 021316 001 5916595
6080778
6485748

Dec 12, 2017

Mar 23, 2018
Dec 12, 2017

DP

LOVASTATIN - ALTOPREV

N 021316 002 5916595
6080778
6485748

Dec 12, 2017

Mar 23, 2018
Dec 12, 2017

DP

LOVASTATIN - ALTOPREV
N 021316 003 5916595
6080778
6485748

Dec 12, 2017

Mar 23, 2018
Dec 12, 2017

DP

U-456

U-456

U-456

ADA 131 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LOVASTATIN - ALTOPREV
N 021316 003 5916595
6080778
6485748

Dec 12, 2017

Mar 23, 2018
Dec 12, 2017

DP

LOVASTATIN - ALTOPREV
N 021316 004 5916595
6080778
6485748

Dec 12, 2017

Mar 23, 2018
Dec 12, 2017

DP

LOVASTATIN; NIACIN - ADVICOR

N 021249 001 6080428
6080428
6080428
6080428
6469035
6469035
6469035
6469035

May
May
May
May
Mar
Mar
Mar
Mar

27,
27,
27,
27,
15,
15,
15,
15,

2017
2017
2017
2017
2018
2018
2018
2018

U-447
U-1132
U-1133
U-1134
U-768
U-1129
U-1130
U-1131

LOVASTATIN; NIACIN - ADVICOR

N 021249 002 6080428
6080428
6080428
6080428
6469035
6469035
6469035
6469035

May
May
May
May
Mar
Mar
Mar
Mar

27,
27,
27,
27,
15,
15,
15,
15,

2017
2017
2017
2017
2018
2018
2018
2018

U-447
U-1132
U-1133
U-1134
U-768
U-1129
U-1130
U-1131

LOVASTATIN; NIACIN - ADVICOR

N 021249 003 6080428
6080428
6080428
6080428
6469035
6469035
6469035
6469035

May
May
May
May
Mar
Mar
Mar
Mar

27,
27,
27,
27,
15,
15,
15,
15,

2017
2017
2017
2017
2018
2018
2018
2018

U-447
U-1132
U-1133
U-1134
U-768
U-1129
U-1130
U-1131

LOVASTATIN; NIACIN - ADVICOR

N 021249 004 6080428
6080428
6080428
6080428
6469035
6469035
6469035
6469035

May
May
May
May
Mar
Mar
Mar
Mar

27,
27,
27,
27,
15,
15,
15,
15,

2017
2017
2017
2017
2018
2018
2018
2018

U-447
U-1132
U-1133
U-1134
U-768
U-1129
U-1130
U-1131

LOXAPINE - ADASUVE
N 022549 001 6716416
7052679
7078020
7090830
7458374
7537009
7585493
7601337
8074644
8173107
8235037
8387612
8955512
8991387

May
Oct
Oct
Oct
Aug
Oct
Oct
Oct
Jul
Oct
Oct
Oct
Oct
May

20,
26,
26,
26,
18,
28,
26,
26,
25,
26,
26,
23,
26,
21,

2022
2021
2021
2021
2024
2024
2021
2021
2022
2021
2021
2026
2021
2024

DP
DP
DP U-1375
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

LUBIPROSTONE - AMITIZA

N 021908 001 6414016
6414016
6583174

Sep 05, 2020

Sep 05, 2020
Oct 16, 2020

PATENT NO

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-456

U-456

U-717
U-1392

DP

NDF

Dec 21, 2015

I-670

Apr 19, 2016

ADA 132 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

LUBIPROSTONE - AMITIZA
N 021908 001 6982283
7064148
7064148
7417067
8026393
8071613
8071613
8088934
8097649
8097653
8097653
8114890
8338639
8389542
8389542
8748481
8779187

Dec
Aug
Aug
Oct
Oct
Sep
Sep
May
Oct
Nov
Nov
Sep
Jan
Nov
Nov
Sep
Jul

04,
30,
30,
16,
25,
05,
05,
18,
16,
14,
14,
05,
23,
14,
14,
01,
23,

2022
2022
2022
2020
2027
2020
2020
2021
2020
2022
2022
2020
2027
2022
2022
2025
2027

LUBIPROSTONE - AMITIZA
N 021908 002 6414016
6583174
7064148
7064148
7417067
7795312
8026393
8071613
8088934
8097649
8114890
8338639
8748481
8779187

Sep
Oct
Aug
Aug
Oct
Sep
Oct
Sep
May
Oct
Sep
Jan
Sep
Jan

05,
16,
30,
30,
16,
17,
25,
05,
18,
16,
05,
23,
01,
23,

2020
2020
2022
2022
2020
2024
2027
2020
2021
2020
2020
2027
2025
2027

LULICONAZOLE - LUZU
N 204153 001 5900488
8980931
9012484

Jul 05, 2016

Apr 28, 2034
Sep 06, 2033

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1391
U-739
U-1404
DP
DP
U-1203
U-1393
DS
DP
U-1214
U-1394
DP
DP
DP U-1345
DP U-1395
U-1520
DP

U-874
DP
U-739
U-873
DP
U-1085
DP
U-1202
DS
DP
DP
DP
U-1519
DP

DS DP U-540
DP
DS DP U-540

NCE

Nov 14, 2018

I-674
NCE

Jun 28, 2016

Oct 28, 2015

I-674
NCE

Jun 28, 2016

Oct 28, 2015

I-674
NCE

Jun 28, 2016

Oct 28, 2015

I-674
NCE

Jun 28, 2016

Oct 28, 2015

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 001 5532372
Jul
8729085
May
8883794
May
9174975
Jun
RE45573
Jun

02,
26,
26,
25,
23,

2018
2026
2026
2026
2025

DS

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 002 5532372
Jul
8729085
May
8883794
May
9174975
Jun
RE45573
Jun

02,
26,
26,
25,
23,

2018
2026
2026
2026
2025

DS

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 003 5532372
Jul
8729085
May
8883794
May
9174975
Jun
RE45573
Jun

02,
26,
26,
25,
23,

2018
2026
2026
2026
2025

DS

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 004 5532372
Jul
8729085
May
8883794
May
9174975
Jun
RE45573
Jun

02,
26,
26,
25,
23,

2018
2026
2026
2026
2025

DS

DP
DP
U-1770
DS

DP
DP
U-1770
DS

DP
DP
U-1770
DS

DP
DP
U-1770
DS

ADA 133 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 005 5532372
Jul 02, 2018
8729085
May 26, 2026
8883794
May 26, 2026
9174975
Jun 25, 2026
RE45573
Jun 23, 2025
PATENT NO

MACITENTAN - OPSUMIT

N 204410 001 7094781
8268847
8367685

Oct 12, 2022

Apr 18, 2029
Oct 04, 2028

PATENT
CODES

PATENT
DELIST
REQUESTED

DS
DP
DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

I-674
NCE

Jun 28, 2016

Oct 28, 2015

NCE
ODE

Oct 18, 2018

Oct 18, 2020

U-1770

DS

DS DP
U-1446
DP U-1445

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 25

N 021910 001 5945449
Oct 31, 2017
DP U-785

7300674
Mar 04, 2023
DP U-785

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 35

N 021910 002 5945449
Oct 31, 2017
DP U-785

MAGNESIUM HYDROXIDE; OMEPRAZOLE;
N 021850 001 6489346
6645988
6699885
7399772

SODIUM BICARBONATE - ZEGERID

Jul 16, 2016
DS DP U-588

Jul 16, 2016
DS DP U-588

Jul 16, 2016
U-588

Jul 16, 2016
U-588

MAGNESIUM HYDROXIDE; OMEPRAZOLE;

N 021850 002 6489346
6645988
6699885
7399772

SODIUM BICARBONATE - ZEGERID

Jul 16, 2016
DS DP U-623

Jul 16, 2016
DS DP U-623

Jul 16, 2016
U-623

Jul 16, 2016
U-623

MAGNESIUM HYDROXIDE; OMEPRAZOLE;

BICARBONATE

N 022456 001 6489346
6489346
6645988
6699885
6699885
7399772
7399772

SODIUM BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM

MAGNESIUM HYDROXIDE; OMEPRAZOLE;

BICARBONATE

N 022456 002 6489346
6489346
6645988
6699885
6699885
7399772
7399772

Jul
Jul
Jul
Jul
Jul
Jul
Jul

16,
16,
16,
16,
16,
16,
16,

2016
2016
2016
2016
2016
2016
2016

DP U-588

DP U-1021

DP

DP U-588

DP U-1021

DP U-588

DP U-1021

SODIUM BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM

Jul
Jul
Jul
Jul
Jul
Jul
Jul

16,
16,
16,
16,
16,
16,
16,

2016
2016
2016
2016
2016
2016
2016

DP U-588

DP U-1021

DP

DP U-588

DP U-1021

DP U-588

DP U-1021

MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE - SUPREP BOWEL PREP KIT

N 022372 001 6946149
Mar 07, 2023
DP U-837

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE;

SODIUM CHLORIDE; SODIUM SULFATE - SUCLEAR

N 203595 001
NC
Jan 18, 2016

MALATHION - OVIDE

N 018613 001 7560445
7977324

Feb 01, 2027

Aug 14, 2026

DS DP U-986

DP

MARAVIROC - SELZENTRY

N 022128 001 6586430
6667314
7368460
7576097

Dec
Aug
Nov
May

2019
2021
2022
2021

DS DP U-824

DS DP U-824

U-824

DS

MARAVIROC - SELZENTRY

N 022128 002 6586430
6667314

Dec 01, 2019

Aug 06, 2021

DS DP U-824

DS DP U-824

01,
06,
25,
25,

ADA 134 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

MARAVIROC - SELZENTRY
N 022128 002 7368460
7576097

PATENT
EXPIRATION
DATE
Nov 25, 2022
May 25, 2021

MECASERMIN RECOMBINANT - INCRELEX

N 021839 001 5681814
Sep 18, 2017
MECHLORETHAMINE HYDROCHLORIDE - VALCHLOR
N 202317 001 7838564
Mar 07, 2026
7872050
Jul 08, 2029
8450375
Mar 07, 2026
8501818
Mar 07, 2026
8501819
Mar 07, 2026

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-824
DS

DP

DP

NDF
ODE

Aug 23, 2016

Aug 23, 2020

MELOXICAM - VIVLODEX
N 207233 001

NP

Oct 22, 2018

MELOXICAM - VIVLODEX
N 207233 002

NP

Oct 22, 2018

M-138
PED

Jul 03, 2017

Jan 03, 2018

M-138
PED

Jul 03, 2017

Jan 03, 2018

U-1427
DP
DP
U-1427

MEDROXYPROGESTERONE ACETATE - DEPO-SUBQ PROVERA 104

N 021583 001 6495534
May 15, 2020
DP
MEGESTROL ACETATE - MEGACE ES
N 021778 001 6592903
7101576
9040088
9101540
9101549
9107827

Sep
Apr
Apr
Apr
Apr
Apr

2020
2024
2024
2024
2024
2024

DP

MELOXICAM - MOBIC
N 021530 001 6184220

Mar 25, 2019

DP

21,
22,
22,
22,
22,
22,

U-755
U-755
DP U-755
U-755
U-755

MEMANTINE HYDROCHLORIDE - NAMENDA

N 021487 001 5061703*PED
Oct 11, 2015
MEMANTINE HYDROCHLORIDE - NAMENDA
N 021487 002 5061703*PED
Oct 11, 2015
MEMANTINE HYDROCHLORIDE - NAMENDA
N 021627 001 5061703*PED
Oct 11, 2015
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 001 5061703*PED
Oct
8039009
Mar
8039009*PED
Sep
8168209
Nov
8168209*PED
May
8173708
Nov
8173708*PED
May
8283379
Nov
8283379*PED
May
8329752
Nov
8329752*PED
May
8362085
Nov
8362085*PED
May

11,
24,
24,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,

2015
2029
2029
2025
2026
2025
2026
2025
2026
2025
2026
2025
2026

MEMANTINE HYDROCHLORIDE - NAMENDA XR

N 022525 002 5061703*PED
Oct
8039009
Mar
8039009*PED
Sep
8168209
Nov
8168209*PED
May
8173708
Nov
8173708*PED
May
8283379
Nov
8283379*PED
May
8329752
Nov
8329752*PED
May

11,
24,
24,
22,
22,
22,
22,
22,
22,
22,
22,

2015
2029
2029
2025
2026
2025
2026
2025
2026
2025
2026

U-539
DP
U-539
U-539
DP
U-539

U-539
DP
U-539
U-539
DP

ADA 135 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 002 8362085
Nov 22, 2025
8362085*PED
May 22, 2026
APPL/PROD
NO

PATENT NO

MEMANTINE HYDROCHLORIDE - NAMENDA XR

N 022525 003 5061703*PED
Oct
8039009
Mar
8039009*PED
Sep
8168209
Nov
8168209*PED
May
8173708
Nov
8173708*PED
May
8283379
Nov
8283379*PED
May
8329752
Nov
8329752*PED
May
8362085
Nov
8362085*PED
May

11,
24,
24,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,

2015
2029
2029
2025
2026
2025
2026
2025
2026
2025
2026
2025
2026

MEMANTINE HYDROCHLORIDE - NAMENDA XR

N 022525 004 5061703*PED
Oct
8039009
Mar
8039009*PED
Sep
8168209
Nov
8168209*PED
May
8173708
Nov
8173708*PED
May
8283379
Nov
8283379*PED
May
8329752
Nov
8329752*PED
May
8362085
Nov
8362085*PED
May
8598233
Nov
8598233*PED
May

11,
24,
24,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,

2015
2029
2029
2025
2026
2025
2026
2025
2026
2025
2026
2025
2026
2025
2026

PATENT
CODES

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-539

U-539

M-138
PED

Jul 03, 2017

Jan 03, 2018

M-138
PED

Jul 03, 2017

Jan 03, 2018

D-139

Feb 19, 2017

ODE

Apr 28, 2021

DP
U-539
U-539
DP
U-539

U-539
DP
U-539
U-539
DP
U-539
DP

MENOTROPINS (FSH;LH); MENOTROPINS (FSH;LH) - MENOPUR

N 021663 001
MENTHOL; METHYL SALICYLATE - SALONPAS
N 022029 001 8809615
Jan 03, 2030

DP

MENTHOL; METHYL SALICYLATE - SALONPAS

N 022029 002 8809615
Jan 03, 2030

DP

MEQUINOL; TRETINOIN - SOLAGE

N 020922 001 6353029

PATENT
DELIST
REQUESTED

Aug 24, 2020

MERCAPTOPURINE - PURIXAN
N 205919 001
MESALAMINE - SFROWASA
N 019618 002 7645801

Jul 24, 2027

DS DP

MESALAMINE - CANASA
N 021252 002 8217083
8436051

Jun 06, 2028

Jun 06, 2028

DP
DP

MESALAMINE - ASACOL HD
N 021830 001 6893662
8580302
9089492

Nov 15, 2021

Nov 15, 2021
Nov 15, 2021

DP U-141
DP
DP

MESALAMINE - LIALDA
N 022000 001 6773720

Jun 08, 2020

DP

MESALAMINE - APRISO
N 022301 001 6551620
8337886
8496965

Apr 20, 2018

Apr 20, 2018
Apr 20, 2018

DS DP U-907
DP U-1310
DP

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 136 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MESALAMINE - APRISO
N 022301 001 8865688
8911778
8940328
8956647

May
Apr
Apr
Apr

U-1310
DP U-1310
DP
DP

MESALAMINE - DELZICOL
N 204412 001 6649180

Apr 13, 2020

METAXALONE - SKELAXIN
N 013217 003 7122566
7714006

Feb 06, 2026

Dec 03, 2021

PATENT NO

01,
20,
20,
20,

2030
2018
2018
2018

DP

U-915
U-1050

METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR

N 021202 001 6475521
Mar 19, 2018
6660300
Mar 19, 2018

U-542

METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR

N 021202 004 6475521
Mar 19, 2018
6660300
Mar 19, 2018

U-542

METFORMIN HYDROCHLORIDE - FORTAMET

N 021574 001 6099859
Mar
6495162
Mar
6790459
Mar
6866866
Mar
7919116
Mar
8475841
Mar

20,
20,
17,
17,
20,
20,

2018
2018
2021
2021
2018
2018

DP
DP

METFORMIN HYDROCHLORIDE - FORTAMET

N 021574 002 6099859
Mar
6495162
Mar
6790459
Mar
6866866
Mar
7919116
Mar
8475841
Mar

20,
20,
17,
17,
20,
20,

2018
2018
2021
2021
2018
2018

DP
DP

U-604
DP
DP
U-604

U-604
DP
DP
U-604

METFORMIN HYDROCHLORIDE - RIOMET

N 021591 001 6890957
Sep 14, 2023
METFORMIN HYDROCHLORIDE - GLUMETZA
N 021748 001 6340475
Sep
6488962
Jun
6635280
Sep
6723340
Oct

19,
20,
19,
25,

2016
2020
2016
2021

METFORMIN HYDROCHLORIDE - GLUMETZA

N 021748 002 6488962
Jun 20, 2020
7780987
Mar 23, 2025
8323692
Mar 23, 2025

PATENT
DELIST
REQUESTED

DP

DS
DS
DS
DS

DP U-669
DP
DP
DP

DS DP
DS DP
DP

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET

N 021842 001 5965584
Jun 19, 2016
DP U-1055
6166042
Jun 19, 2016
U-679
6166043
Jun 19, 2016
U-679
6172090
Jun 19, 2016
U-679
9101660
Jan 22, 2027
DP
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET
N 021842 002 5965584
Jun 19, 2016
DP U-1055
6166042
Jun 19, 2016
U-679
6166043
Jun 19, 2016
U-679
6172090
Jun 19, 2016
U-679
9101660
Jan 22, 2027
DP
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR
N 022024 001 5965584
Jun 19, 2016
DP U-973
6099859
Mar 20, 2018
DP
6166042
Jun 19, 2016
U-973
6166043
Jun 19, 2016
U-973

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 137 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
N 022024 001 6172090
Jun 19, 2016
6495162
Mar 20, 2018
6790459
Mar 17, 2021
6866866
Mar 17, 2021
7785627
Jul 31, 2026
7919116
Mar 20, 2018
7919116
Mar 20, 2018
7959946
Jul 31, 2026
8470368
Sep 19, 2023
8475841
Mar 20, 2018
8668931
Sep 19, 2023
9060941
Sep 19, 2023

PATENT
DELIST
PATENT
REQUESTED
CODES
- ACTOPLUS MET XR
U-973
DP
U-974
DP
DP
U-973
U-1120
DP
DP
U-973
DP
DP

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

N 022024 002 5965584
Jun 19, 2016
6099859
Mar 20, 2018
6166042
Jun 19, 2016
6166043
Jun 19, 2016
6172090
Jun 19, 2016
6495162
Mar 20, 2018
6790459
Mar 17, 2021
6866866
Mar 17, 2021
7785627
Jul 31, 2026
7919116
Mar 20, 2018
7919116
Mar 20, 2018
7959946
Jul 31, 2026
8470368
Sep 19, 2023
8475841
Mar 20, 2018
8668931
Sep 19, 2023
9060941
Sep 19, 2023

- ACTOPLUS MET XR
DP U-973
DP
U-973
U-973
U-973
DP
U-974
DP
DP
U-973
U-1120
DP
DP
U-973
DP
DP

PATENT NO

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

N 021410 001 5965584
Jun 19, 2016
U-493
6166042
Jun 19, 2016
U-493
6288095
Feb 11, 2017
U-493
7358366
Apr 19, 2020
DS
8236345
Oct 07, 2022
DP
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 002 5965584
Jun 19, 2016
U-493
6166042
Jun 19, 2016
U-493
6288095
Feb 11, 2017
U-493
7358366
Apr 19, 2020
DS
8236345
Oct 07, 2022
DP
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 003 5965584
Jun 19, 2016
U-493
6166042
Jun 19, 2016
U-493
6288095
Feb 11, 2017
U-493
7358366
Apr 19, 2020
DS
8236345
Oct 07, 2022
DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

Y
Y
Y

Y
Y
Y

Y
Y
Y

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

N 021410 004 7358366
Apr 19, 2020
DS
8236345
Oct 07, 2022
DP
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 005 7358366
Apr 19, 2020
DS
8236345
Oct 07, 2022
DP
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR
N 200678 001 8628799
Jul 13, 2025
DP
RE44186
Jul 31, 2023
DS DP U-1097
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR
N 200678 002 RE44186
Jul 31, 2023
DS DP U-1097

M-134

May 24, 2016

M-134

May 24, 2016

ADA 138 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
PATENT

EXPIRATION
DELIST

PATENT
DATE
REQUESTED

CODES
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR

N 200678 003 RE44186
Jul 31, 2023
DS DP U-1097

PATENT NO

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET

N 022044 001 6699871
Jul 26, 2022
DS DP U-802

7125873
Jul 26, 2022
DP U-803

7125873
Jul 26, 2022
DP U-1036

7125873
Jul 26, 2022
DP U-1038

7326708
Apr 11, 2026
DS DP U-802

8414921
Jul 21, 2028
DP U-1036

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET

N 022044 002 6699871
Jul 26, 2022
DS DP U-802

7125873
Jul 26, 2022
DP U-803

7125873
Jul 26, 2022
DP U-1036

7125873
Jul 26, 2022
DP U-1038

7326708
Apr 11, 2026
DS DP U-802

8414921
Jul 21, 2028
DP U-1036

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR

N 202270 001 6340475
Sep 19, 2016
DP

6635280
Sep 19, 2016
DP

6699871
Jul 26, 2022
DS DP U-1227

7125873
Jul 26, 2022
DP U-1227

7326708
Apr 11, 2026
DS DP U-1227

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR

N 202270 002 6340475
Sep 19, 2016
DP

6635280
Sep 19, 2016
DP

6699871
Jul 26, 2022
DS DP U-1227

7125873
Jul 26, 2022
DP U-1227

7326708
Apr 11, 2026
DS DP U-1227

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR

N 202270 003 6340475

Sep 19, 2016
DP

6635280

Sep 19, 2016
DP

6699871

Jul 26, 2022
DS DP U-1227

7125873

Jul 26, 2022
DP U-1227

7326708

Apr 11, 2026
DS DP U-1227

METHOTREXATE - OTREXUP

N 204824 001 6746429

7744582

7776015

8021335

8480631

8562564

8579865

8945063

RE44846

RE44847

Apr
Aug
Aug
Oct
Mar
Jan
Mar
Mar
Aug
Aug

12,
10,
10,
04,
19,
24,
19,
19,
10,
10,

2020
2019
2019
2026
2030
2026
2030
2030
2019
2019

DP

DP U-1442

DP

DP

DP U-1442

DP

DP U-1442

DP U-1442

DP

DP U-1442

METHOTREXATE - OTREXUP

N 204824 002 6746429

7744582

7776015

8021335

8480631

8562564

8579865

8945063

RE44846

RE44847

Apr
Aug
Aug
Oct
Mar
Jan
Mar
Mar
Aug
Aug

12,
10,
10,
04,
19,
24,
19,
19,
10,
10,

2020
2019
2019
2026
2030
2026
2030
2030
2019
2019

DP

DP U-1442

DP

DP

DP U-1442

DP

DP U-1442

DP U-1442

DP

DP U-1442

METHOTREXATE - OTREXUP

N 204824 003 6746429

7744582

7776015

8021335

8480631

Apr
Aug
Aug
Oct
Mar

12,
10,
10,
04,
19,

2020
2019
2019
2026
2030

DP

DP U-1442

DP

DP

DP U-1442

EXCLUSIVITY
CODE(S)
M-134

EXCLUSIVITY

EXPIRATION

DATE

May 24, 2016

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 139 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

METHOTREXATE - OTREXUP
N 204824 003 8562564
8579865
8945063
RE44846
RE44847

Jan
Mar
Mar
Aug
Aug

24,
19,
19,
10,
10,

2026
2030
2030
2019
2019

DP
DP U-1442
DP U-1442
DP
DP U-1442

METHOTREXATE - OTREXUP
N 204824 004 6746429
7744582
7776015
8021335
8480631
8562564
8579865
8945063
RE44846
RE44847

Apr
Aug
Aug
Oct
Mar
Jan
Mar
Mar
Aug
Aug

12,
10,
10,
04,
19,
24,
19,
19,
10,
10,

2020
2019
2019
2026
2030
2026
2030
2030
2019
2019

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

METHOTREXATE - OTREXUP
N 204824 005 6746429
8021335
8480631
8562564
8579865
8945063
RE44846
RE44847

Apr
Oct
Mar
Jan
Mar
Mar
Aug
Aug

12,
04,
19,
24,
19,
19,
10,
10,

2020
2026
2030
2026
2030
2030
2019
2019

DP
DP
DP
DP
DP
DP
DP
DP

METHOTREXATE - RASUVO
N 205776 001 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 002 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 003 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 004 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 005 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 006 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 007 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 008 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 009 8664231

Jun 01, 2029

U-1442

METHOTREXATE - RASUVO
N 205776 010 8664231

Jun 01, 2029

U-1442

PATENT NO

METHYL AMINOLEVULINATE HYDROCHLORIDE - METVIXIA

N 021415 001 6034267
Mar 08, 2016
METHYLNALTREXONE BROMIDE - RELISTOR
N 021964 001 6559158
Nov
8247425
Dec
8420663
Sep
8552025
Apr
8822490
Sep
9180125
Sep

03,
31,
30,
08,
30,
30,

2017
2030
2029
2024
2029
2029

U-1442

U-1442
U-1442
U-1442
U-1442

U-1442
U-1442
U-1442
U-1442

U-804

U-1185
U-1185
U-1185
DP
DP U-1185
DP U-1185

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 140 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
METHYLNALTREXONE BROMIDE - RELISTOR
N 021964 002 6559158
Nov 03, 2017
8247425
Dec 31, 2030
8420663
Sep 30, 2029
8552025
Apr 08, 2024
8822490
Sep 30, 2029
9180125
Sep 30, 2029
APPL/PROD
NO

PATENT NO

PATENT
CODES
U-1185
U-1185
U-1185
DP
DP U-1185
DP U-1185

METHYLNALTREXONE BROMIDE - RELISTOR

N 021964 003 8247425
Dec
8420663
Sep
8552025
Apr
8822490
Sep
9180125
Sep

31,
30,
08,
30,
30,

2030
2029
2024
2029
2029

DP
DP U-1185
DP U-1185

METHYLPHENIDATE - DAYTRANA
N 021514 001 6210705
6348211
8632802
9034370

Sep
Sep
Oct
Oct

30,
30,
07,
07,

2018
2018
2025
2025

DP U-727
DP U-727
DP
DP

METHYLPHENIDATE - DAYTRANA
N 021514 002 6210705
6348211
8632802
9034370

Sep
Sep
Oct
Oct

30,
30,
07,
07,

2018
2018
2025
2025

DP U-727
DP U-727
DP
DP

METHYLPHENIDATE - DAYTRANA
N 021514 003 6210705
6348211
8632802
9034370

Sep
Sep
Oct
Oct

30,
30,
07,
07,

2018
2018
2025
2025

DP U-727
DP U-727
DP
DP

METHYLPHENIDATE - DAYTRANA
N 021514 004 6210705
6348211
8632802
9034370

Sep
Sep
Oct
Oct

30,
30,
07,
07,

2018
2018
2025
2025

DP U-727
DP U-727
DP
DP

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N 021121 001 6919373
Jul 31, 2017
6930129
Jul 31, 2017
8163798
Jul 31, 2017
8629179
Jul 31, 2017
8629179*PED
Jan 31, 2018
9000038
Jul 31, 2017
9000038
Jul 31, 2017
9000038*PED
Jan 31, 2018
9029416
Jul 31, 2017
9144549
Jul 31, 2017
9144549
Jul 31, 2017
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 002 6919373
Jul 31, 2017
6930129
Jul 31, 2017
8163798
Jul 31, 2017
8629179
Jul 31, 2017
8629179*PED
Jan 31, 2018
9000038
Jul 31, 2017
9000038
Jul 31, 2017
9000038*PED
Jan 31, 2018
9029416
Jul 31, 2017
9144549
Jul 31, 2017
9144549
Jul 31, 2017
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 003 6919373
Jul 31, 2017
6930129
Jul 31, 2017
8163798
Jul 31, 2017
8629179
Jul 31, 2017

U-1185
U-1185

U-666
U-666
DP
DP
U-666
U-1693
DP U-666
U-1747
U-1748

U-666
U-666
DP
DP
U-666
U-1693
DP U-666
U-1747
U-1748

U-666
U-666
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 141 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 003 8629179*PED
Jan 31, 2018
9000038
Jul 31, 2017
9000038
Jul 31, 2017
9000038*PED
Jan 31, 2018
9029416
Jul 31, 2017
9144549
Jul 31, 2017
9144549
Jul 31, 2017
APPL/PROD
NO

PATENT NO

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N 021121 004 6919373
Jul 31, 2017
6930129
Jul 31, 2017
8163798
Jul 31, 2017
8629179
Jul 31, 2017
8629179*PED
Jan 31, 2018
9000038
Jul 31, 2017
9000038
Jul 31, 2017
9000038*PED
Jan 31, 2018
9029416
Jul 31, 2017
9144549
Jul 31, 2017
9144549
Jul 31, 2017

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-666
U-1693
DP U-666
U-1747
U-1748

U-666
U-666
DP
DP
U-666
U-1693
DP U-666
U-1747
U-1748

METHYLPHENIDATE HYDROCHLORIDE - METADATE CD

N 021259 001 6344215
Oct 27, 2020

DP

METHYLPHENIDATE HYDROCHLORIDE - METADATE CD

N 021259 002 6344215
Oct 27, 2020

DP

METHYLPHENIDATE HYDROCHLORIDE - METADATE CD

N 021259 003 6344215
Oct 27, 2020

DP

METHYLPHENIDATE HYDROCHLORIDE - METADATE CD

N 021259 004 6344215
Oct 27, 2020

DP

METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA

N 021284 001 5837284
Dec 04, 2015
6228398
Nov 01, 2019
6635284
Dec 04, 2015
7431944
Dec 04, 2015

DP
DP U-472
DP U-591
DP

METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA

N 021284 002 5837284
Dec 04, 2015
6228398
Nov 01, 2019
6635284
Dec 04, 2015
7431944
Dec 04, 2015

DP
DP U-472
DP U-591
DP

METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA

N 021284 003 5837284
Dec 04, 2015
6228398
Nov 01, 2019
6635284
Dec 04, 2015
7431944
Dec 04, 2015

DP
DP U-472
DP U-591
DP

METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA

N 021284 004 5837284
Dec 04, 2015
6228398
Nov 01, 2019
6635284
Dec 04, 2015
7431944
Dec 04, 2015

DP
DP U-472
DP U-591
DP

METHYLPHENIDATE HYDROCHLORIDE - METHYLIN

N 021419 001 7691880
Oct 07, 2024

DP

METHYLPHENIDATE HYDROCHLORIDE - METHYLIN

N 021419 002 7691880
Oct 07, 2024

DP

METHYLPHENIDATE HYDROCHLORIDE - QUILLIVANT XR

N 202100 001 8062667
Mar 29, 2029
8287903
Feb 15, 2031
8465765
Feb 15, 2031
8563033
Feb 15, 2031
8778390
Feb 15, 2031

DP
DP
DP U-1415
DP U-1415
DP U-1543

NDF

Sep 27, 2015

ADA 142 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT

EXPIRATION

DATE

METHYLPHENIDATE HYDROCHLORIDE - QUILLIVANT XR

N 202100 001 8956649
Feb 15, 2031

9040083
Feb 15, 2031

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-1665
DP

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR

N 205831 001 6419960
Dec 16, 2019

7083808
Dec 16, 2019

7247318
Dec 16, 2019

7438930
Dec 16, 2019

8580310
Dec 16, 2019

9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR

N 205831 002 6419960
Dec 16, 2019

7083808
Dec 16, 2019

7247318
Dec 16, 2019

7438930
Dec 16, 2019

8580310
Dec 16, 2019

9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR

N 205831 003 6419960
Dec 16, 2019

7083808
Dec 16, 2019

7247318
Dec 16, 2019

7438930
Dec 16, 2019

8580310
Dec 16, 2019

9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR

N 205831 004 6419960
Dec 16, 2019

7083808
Dec 16, 2019

7247318
Dec 16, 2019

7438930
Dec 16, 2019

8580310
Dec 16, 2019

9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR

N 205831 005 6419960
Dec 16, 2019

7083808
Dec 16, 2019

7247318
Dec 16, 2019

7438930
Dec 16, 2019

8580310
Dec 16, 2019

9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR

N 205831 006 6419960
Dec 16, 2019

7083808
Dec 16, 2019

7247318
Dec 16, 2019

7438930
Dec 16, 2019

8580310
Dec 16, 2019

9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR

N 205831 007 6419960
Dec 16, 2019

7083808
Dec 16, 2019

7247318
Dec 16, 2019

7438930
Dec 16, 2019

8580310
Dec 16, 2019

9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - QUILLICHEW ER

N 207960 001 8202537
Mar 15, 2027

8287903
Feb 15, 2031

8999386
Apr 14, 2033

DP
DP
DP

METHYLPHENIDATE HYDROCHLORIDE - QUILLICHEW ER

N 207960 002 8202537
Mar 15, 2027

8287903
Feb 15, 2031

8999386
Apr 14, 2033

DP
DP
DP

ADA 143 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
METHYLPHENIDATE HYDROCHLORIDE - QUILLICHEW ER
N 207960 003 8202537
Mar 15, 2027
8287903
Feb 15, 2031
8999386
Apr 14, 2033
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP
DP

METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT

N 021793 001 6024981
Apr 09, 2018
6221392
Apr 09, 2018

DP
DP

METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT

N 021793 002 6024981
Apr 09, 2018
6221392
Apr 09, 2018

DP
DP

METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT

N 022246 001 6413549
Jul 11, 2017

DP

METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT

N 022246 002 6413549
Jul 11, 2017

DP

METRONIDAZOLE - METROGEL
N 021789 001 6881726
7348317

Feb 21, 2022

Feb 21, 2022

DP U-743
DP U-743

METRONIDAZOLE - VANDAZOLE
N 021806 001 7456207

Sep 22, 2024

DP

METRONIDAZOLE - NUVESSA
N 205223 001 7893097
8658678
8877792
8946276
9198858

Feb
Jun
Feb
Jun
Jun

19,
27,
02,
28,
28,

2028
2028
2028
2032
2032

DP

MICAFUNGIN SODIUM - MYCAMINE

N 021506 002 6107458
6107458
6265536
6265536
6774104
6774104

Mar
Mar
Sep
Sep
Jan
Jan

16,
16,
29,
29,
08,
08,

2019
2019
2015
2015
2021
2021

DS
DS
DS
DS

DP
DP
DP
DP
DP
DP

U-650
U-845
U-650
U-845
U-650
U-845

MICAFUNGIN SODIUM - MYCAMINE

N 021506 003 6107458
6107458
6265536
6265536
6774104
6774104

Mar
Mar
Sep
Sep
Jan
Jan

16,
16,
29,
29,
08,
08,

2019
2019
2015
2015
2021
2021

DS
DS
DS
DS

DP
DP
DP
DP
DP
DP

U-650
U-845
U-650
U-845
U-650
U-845

MICONAZOLE - ORAVIG
N 022404 001 6916485
7651698
8518442

Sep 11, 2022

Sep 11, 2022
Sep 11, 2022

NP

Mar 24, 2017

ODE

Feb 17, 2019

U-1682
DP
U-1664
U-1664

DP U-1051
U-1051
DP

MICONAZOLE NITRATE; MICONAZOLE NITRATE - MONISTAT 1 COMBINATION PACK

N 021308 001 6153635
Nov 28, 2020

MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE - VUSION

N 021026 001 8147852
Mar 30, 2028
U-1426
MIFEPRISTONE - KORLYM
N 202107 001 8921348

Aug 27, 2028

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N 022256 001 6602911
Jan
6992110
Nov
7888342
Nov
7994220
Sep

14,
05,
05,
19,

2023
2021
2021
2029

U-1643

U-882
U-882
U-882
U-819

ADA 144 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N 022256 002 6602911
Jan 14, 2023
6992110
Nov 05, 2021
7888342
Nov 05, 2021
7994220
Sep 19, 2029
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

U-882
U-882
U-882
U-819

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N 022256 003 6602911
Jan
6992110
Nov
7888342
Nov
7994220
Sep

14,
05,
05,
19,

2023
2021
2021
2029

U-882
U-882
U-882
U-819

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N 022256 004 6602911
Jan
6992110
Nov
7888342
Nov
7994220
Sep

14,
05,
05,
19,

2023
2021
2021
2029

U-882
U-882
U-882
U-819

MILTEFOSINE - IMPAVIDO
N 204684 001

NCE
ODE

MINOCYCLINE HYDROCHLORIDE - MINOCIN

N 050444 001 9084802
May 12, 2031
MINOCYCLINE HYDROCHLORIDE - ARESTIN
N 050781 001 6682348
Mar 29, 2022
7699609
Mar 29, 2022

EXCLUSIVITY
EXPIRATION
DATE

U-282

DP
DP

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N 050808 001 5908838
Feb
7790705
Jun
7919483
Mar
8252776
Jun
8268804
Jun

19,
24,
07,
24,
24,

2018
2025
2027
2025
2025

U-917
U-1078
U-1078
U-124
U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N 050808 002 5908838
Feb
7541347
Apr
7544373
Apr
7790705
Jun
7919483
Mar
8252776
Jun
8268804
Jun

19,
02,
02,
24,
07,
24,
24,

2018
2027
2027
2025
2027
2025
2025

U-917
U-917

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N 050808 003 5908838
Feb
7790705
Jun
7919483
Mar
8252776
Jun
8268804
Jun

19,
24,
07,
24,
24,

2018
2025
2027
2025
2025

U-917
U-1078
U-1078
U-124
U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N 050808 004 5908838
Feb
7790705
Jun
7919483
Mar
8252776
Jun
8268804
Jun
9192615
Nov

19,
24,
07,
24,
24,
17,

2018
2025
2027
2025
2025
2031

U-917
U-1078
U-1078
U-124
U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N 050808 005 5908838
Feb
7790705
Jun
7919483
Mar
8252776
Jun
8268804
Jun
9192615
Nov

19,
24,
07,
24,
24,
17,

2018
2025
2027
2025
2025
2031

DP
U-1078
U-1078
U-124
U-1078

DP

U-917
U-1078
U-1078
U-124
U-1078
DP

Mar 19, 2019

Mar 19, 2021

ADA 145 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
MINOCYCLINE HYDROCHLORIDE - SOLODYN

N 050808 006 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027
8252776
Jun 24, 2025
8268804
Jun 24, 2025
8722650
Jun 24, 2025
PATENT NO

PATENT
CODES

U-917

U-1078

U-1078

U-124

U-1078

U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N 050808 008 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027
8252776
Jun 24, 2025
8268804
Jun 24, 2025
8722650
Jun 24, 2025

U-917

U-1078

U-1078

U-124

U-1078

U-1078

19,
02,
02,
24,
07,
24,
24,

2018
2027
2027
2025
2027
2025
2025

MINOCYCLINE HYDROCHLORIDE - XIMINO

N 201922 003 5908838
Feb
7541347
Apr
7544373
Apr
7790705
Jun
7919483
Mar
8252776
Jun
8268804
Jun

19,
02,
02,
24,
07,
24,
24,

2018
2027
2027
2025
2027
2025
2025

MINOCYCLINE HYDROCHLORIDE - XIMINO

N 201922 005 5908838
Feb
7541347
Apr
7544373
Apr
7790705
Jun
7919483
Mar
8252776
Jun
8268804
Jun

19,
02,
02,
24,
07,
24,
24,

2018
2027
2027
2025
2027
2025
2025

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-917

U-1078

U-1078

U-124

U-1078

U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N 050808 007 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027
8252776
Jun 24, 2025
8268804
Jun 24, 2025
8722650
Jun 24, 2025

MINOCYCLINE HYDROCHLORIDE - XIMINO

N 201922 001 5908838
Feb
7541347
Apr
7544373
Apr
7790705
Jun
7919483
Mar
8252776
Jun
8268804
Jun

PATENT
DELIST
REQUESTED

U-1376

U-917

DP

U-124

U-124

U-124

U-124

U-1376

U-917

DP

U-124

U-124

U-124

U-124

U-1376

U-917

DP

U-124

U-124

U-124

U-124

MINOXIDIL - MEN'S ROGAINE

N 021812 001 6946120

Apr 20, 2019

DP U-702

MINOXIDIL - WOMEN'S ROGAINE

N 021812 002 6946120

Apr 20, 2019

DP U-702

MIPOMERSEN SODIUM - KYNAMRO

N 203568 001 6166197
6451991
7015315
7101993
7407943
7511131

Dec
Feb
Mar
Sep
Aug
Dec

26,
11,
21,
05,
01,
13,

2017
2017
2023
2023
2021
2025

DS
DS
DS

DS

MIRABEGRON - MYRBETRIQ

N 202611 001 6346532
6562375
7342117
7750029

Oct
Aug
Nov
Dec

15,
01,
04,
18,

2018
2020
2023
2023

DS DP
DP

DS

NP

Feb 28, 2017

NCE
ODE

Jan 29, 2018

Jan 29, 2020

NCE

Jun 28, 2017

U-1353

DS

U-913

ADA 146 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MIRABEGRON - MYRBETRIQ
N 202611 001 7982049
8835474
RE44872

Nov 04, 2023

Nov 04, 2023
Dec 18, 2023

MIRABEGRON - MYRBETRIQ
N 202611 002 6346532
6562375
7342117
7750029
7982049
8835474
RE44872

Oct
Aug
Nov
Dec
Nov
Nov
Dec

2018
2020
2023
2023
2023
2023
2023

DS DP
DP
DS

MITOMYCIN - MITOSOL
N 022572 001 7806265
8186511
9205075

Feb 01, 2029

Jul 19, 2026
Jul 19, 2026

DP
DP
DP

MODAFINIL - PROVIGIL
N 020717 001 7297346

Nov 29, 2023

DP

MODAFINIL - PROVIGIL
N 020717 002 7297346

Nov 29, 2023

DP

15,
01,
04,
18,
04,
04,
18,

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
U-1527
U-1527

NCE

Jun 28, 2017

ODE

Feb 07, 2019

NP

Apr 19, 2016

U-913
DP
U-1527
U-1527

MOMETASONE FUROATE - ELOCON

N 019625 002
MOMETASONE FUROATE - ASMANEX TWISTHALER
N 021067 001 5829434
Nov 03,
6240918
Feb 20,
6503537
Mar 17,
8173172
Mar 17,

2015
2017
2018
2018

DP
DP
DP
DP

MOMETASONE FUROATE - ASMANEX TWISTHALER

N 021067 002 5829434
Nov 03,
6240918
Feb 20,
6503537
Mar 17,
8173172
Mar 17,

2015
2017
2018
2018

DP
DP
DP
DP

MOMETASONE FUROATE - ASMANEX HFA

N 205641 001 6068832
Aug 27, 2017

DP U-645

MOMETASONE FUROATE - ASMANEX HFA

N 205641 002 6068832
Aug 27, 2017

DP U-645

MOMETASONE FUROATE MONOHYDRATE - NASONEX

N 020762 001 6127353
Oct 03, 2017

PATENT
DELIST
REQUESTED

DS DP

MONTELUKAST SODIUM - SINGULAIR

N 021409 001 8007830

Oct 24, 2022

DP

MORPHINE SULFATE - AVINZA

N 021260 001 6066339

Nov 25, 2017

DP

MORPHINE SULFATE - AVINZA

N 021260 002 6066339

Nov 25, 2017

DP

MORPHINE SULFATE - AVINZA

N 021260 003 6066339

Nov 25, 2017

DP

MORPHINE SULFATE - AVINZA

N 021260 004 6066339

Nov 25, 2017

DP

MORPHINE SULFATE - AVINZA

N 021260 005 6066339

Nov 25, 2017

DP

MORPHINE SULFATE - AVINZA

N 021260 006 6066339

Nov 25, 2017

DP

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 147 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MORPHINE SULFATE - DEPODUR

N 021671 001 5807572
5891467
5931809
5962016
5997899
6171613
6193998
6241999

Sep
Jan
Jul
Jan
Sep
Oct
Sep
Sep

15,
31,
14,
31,
01,
01,
01,
01,

2015
2017
2015
2017
2016
2016
2016
2016

DP
DP

MORPHINE SULFATE - DEPODUR

N 021671 002 5807572
5891467
5931809
5962016
5997899
6171613
6193998
6241999

Sep
Jan
Jul
Jan
Sep
Oct
Sep
Sep

15,
31,
14,
31,
01,
01,
01,
01,

2015
2017
2015
2017
2016
2016
2016
2016

DP
DP

MORPHINE SULFATE - DEPODUR

N 021671 003 5807572
5891467
5931809
5962016
5997899
6171613
6193998
6241999

Sep
Jan
Jul
Jan
Sep
Oct
Sep
Sep

15,
31,
14,
31,
01,
01,
01,
01,

2015
2017
2015
2017
2016
2016
2016
2016

DP
DP

MORPHINE SULFATE - MORPHINE SULFATE

N 204223 001 9072781
Mar 12, 2034
9192608
Mar 12, 2034
9192608
Mar 12, 2034
MORPHINE SULFATE - MORPHINE SULFATE
N 204223 002 9072781
Mar 12, 2034
9192608
Mar 12, 2034
9192608
Mar 12, 2034
MORPHINE SULFATE - MORPHINE SULFATE
N 204223 003 9072781
Mar 12, 2034
9192608
Mar 12, 2034
9192608
Mar 12, 2034
MORPHINE SULFATE - MORPHINE SULFATE
N 204223 004 9072781
Mar 12, 2034
9192608
Mar 12, 2034
9192608
Mar 12, 2034
MORPHINE SULFATE - MORPHINE SULFATE
N 204223 005 9072781
Mar 12, 2034
9192608
Mar 12, 2034
9192608
Mar 12, 2034
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 001 7682633
Jun 19, 2027
7682634
Jun 19, 2027
7815934
Dec 12, 2027
8158156
Jun 19, 2027
8623418
Nov 07, 2029
8685443
Jul 03, 2025
8685444
Jul 03, 2025
8846104
Jun 19, 2027
8877247
Jun 19, 2027

U-584
DP U-584
DP
DP
DP
DP

U-584
DP U-584
DP
DP
DP
DP

U-584
DP U-584
DP
DP
DP
DP

DP
U-43
U-55

DP
U-43
U-55

DP
U-43
U-55

DP
U-43
U-55

DP
U-43
U-55

U-1510
DP
DP
U-1510
U-1640
U-1508
DP
DP
DP

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N 022321 002 7682633
Jun 19, 2027
U-1510

7682634
Jun 19, 2027
DP

7815934
Dec 12, 2027
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 148 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
PATENT
DATE
CODES
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N 022321 002 8158156
Jun 19, 2027
U-1510

8623418
Nov 07, 2029
U-1640

8685443
Jul 03, 2025
U-1508

8685444
Jul 03, 2025
DP

8846104
Jun 19, 2027
DP

8877247
Jun 19, 2027
DP

PATENT NO

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N 022321 003 7682633
Jun 19, 2027
7682634
Jun 19, 2027
7815934
Dec 12, 2027
8158156
Jun 19, 2027
8623418
Nov 07, 2029
8685443
Jul 03, 2025
8685444
Jul 03, 2025
8846104
Jun 19, 2027
8877247
Jun 19, 2027
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N 022321 004 7682633
Jun 19, 2027
7682634
Jun 19, 2027
7815934
Dec 12, 2027
8158156
Jun 19, 2027
8623418
Nov 07, 2029
8685443
Jul 03, 2025
8685444
Jul 03, 2025
8846104
Jun 19, 2027
8877247
Jun 19, 2027
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N 022321 005 7682633
Jun 19, 2027
7682634
Jun 19, 2027
7815934
Dec 12, 2027
8158156
Jun 19, 2027
8623418
Nov 07, 2029
8685443
Jul 03, 2025
8685444
Jul 03, 2025
8846104
Jun 19, 2027
8877247
Jun 19, 2027
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N 022321 006 7682633
Jun 19, 2027
7682634
Jun 19, 2027
7815934
Dec 12, 2027
8158156
Jun 19, 2027
8623418
Nov 07, 2029
8685443
Jul 03, 2025
8685444
Jul 03, 2025
8846104
Jun 19, 2027
8877247
Jun 19, 2027
MOXIFLOXACIN HYDROCHLORIDE - AVELOX

N 021085 001 5849752
Dec 05, 2016
6610327
Oct 29, 2019

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

U-1510

DP

DP

U-1510

U-1640

U-1508

DP

DP

DP

U-1510

DP

DP

U-1510

U-1640

U-1508

DP

DP

DP

U-1510

DP

DP

U-1510

U-1640

U-1508

DP

DP

DP

U-1510

DP

DP

U-1510

U-1640

U-1508

DP

DP

DP

U-298

DP U-298

MOXIFLOXACIN HYDROCHLORIDE - AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

N 021277 001 5849752
Dec 05, 2016
U-298

6548079
Jul 25, 2020
DP U-298

MOXIFLOXACIN HYDROCHLORIDE - VIGAMOX

N 021598 001 6716830
Sep 29, 2019
7671070
Sep 29, 2019
MOXIFLOXACIN HYDROCHLORIDE - MOXEZA

N 022428 001 6716830
Sep 29, 2019
7671070
Sep 29, 2019
8450311
May 29, 2029
9114168
May 29, 2029

DP

U-709

DP

DP U-709

DP

DP

EXCLUSIVITY

EXPIRATION

DATE

ADA 149 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MUPIROCIN - CENTANY
N 050788 001 6013657

Jul 08, 2018

DP

MYCOPHENOLIC ACID - MYFORTIC

N 050791 001 6025391
6172107
6306900

Apr 10, 2017

Apr 10, 2017
Feb 27, 2018

DP U-908
DP U-908
DP

MYCOPHENOLIC ACID - MYFORTIC

N 050791 002 6025391
6172107
6306900

Apr 10, 2017

Apr 10, 2017
Feb 27, 2018

DP U-908
DP U-908
DP

PATENT NO

NAFTIFINE HYDROCHLORIDE - NAFTIN

N 204286 001 8778365
Jan 31, 2033
9161914
Jan 31, 2033

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NP

Jun 27, 2016

U-540

NALOXEGOL OXALATE - MOVANTIK

N 204760 001 7056500
7662365
7786133
8067431
8617530
9012469

Jun
Oct
Dec
Dec
Oct
Apr

29,
18,
19,
16,
18,
02,

2024
2022
2027
2024
2022
2032

DP U-1185
DS DP
DP
U-1185
U-1185
DS DP

NCE

Sep 16, 2019

NALOXEGOL OXALATE - MOVANTIK

N 204760 002 7056500
7662365
7786133
8067431
8617530
9012469

Jun
Oct
Dec
Dec
Oct
Apr

29,
18,
19,
16,
18,
02,

2024
2022
2027
2024
2022
2032

DP U-1185
DS DP
DP
U-1185
U-1185
DS DP

NCE

Sep 16, 2019

NALOXONE HYDROCHLORIDE - EVZIO

N 205787 001 7731686
7731690
7749194
7918823
7947017
8016788
8021344
8206360
8226610
8231573
8313466
8361029
8425462
8608698
8627816
8926594
8939943
9022022
9056170

Jun
Jan
Oct
Nov
Mar
Mar
Nov
Feb
Apr
Nov
Nov
Nov
Nov
Nov
Feb
Mar
Feb
Feb
Nov

10,
15,
30,
23,
12,
21,
02,
27,
10,
25,
23,
23,
23,
23,
04,
31,
28,
28,
23,

2026
2025
2028
2024
2028
2025
2029
2027
2029
2028
2024
2024
2024
2024
2032
2026
2031
2031
2024

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

NALOXONE HYDROCHLORIDE - NARCAN

N 208411 001 9211253

Mar 16, 2035

DP

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ

N 205777 001 6277384
Dec 22, 2018
DP
6696066
Dec 22, 2018
DP
7674799
Mar 30, 2025
DP
7674800
Mar 30, 2025
DS
7683072
Mar 30, 2025
DS
8673355
Dec 22, 2018
DP
8822487
Dec 22, 2018
DP
8846090
Apr 04, 2023
DP
8846091
Apr 04, 2023
DP
8969369
May 10, 2022
DP U-1556
9056051
May 10, 2022
DP U-1556
9073933
Mar 30, 2025
DS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 150 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
PATENT
DATE
CODES
OXYCODONE HYDROCHLORIDE - TARGINIQ
May 10, 2022
DP U-1556
May 10, 2022
DP U-1556
May 10, 2022
DP U-1556
May 10, 2022
DP U-1556

PATENT NO

NALOXONE HYDROCHLORIDE;
N 205777 001 9084729
9161937
9168252
9205082

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ

N 205777 002 6277384
Dec 22, 2018
DP
6696066
Dec 22, 2018
DP
7674799
Mar 30, 2025
DP
7674800
Mar 30, 2025
DS
7683072
Mar 30, 2025
DS
8673355
Dec 22, 2018
DP
8822487
Dec 22, 2018
DP
8846090
Apr 04, 2023
DP
8846091
Apr 04, 2023
DP
8969369
May 10, 2022
DP U-1556
9056051
May 10, 2022
DP U-1556
9073933
Mar 30, 2025
DS
9084729
May 10, 2022
DP U-1556
9161937
May 10, 2022
DP U-1556
9168252
May 10, 2022
DP U-1556
9205082
May 10, 2022
DP U-1556
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ
N 205777 003 6277384
Dec 22, 2018
DP
6696066
Dec 22, 2018
DP
7674799
Mar 30, 2025
DP
7674800
Mar 30, 2025
DS
7683072
Mar 30, 2025
DS
8673355
Dec 22, 2018
DP
8822487
Dec 22, 2018
DP
8846090
Apr 04, 2023
DP
8846091
Apr 04, 2023
DP
8969369
May 10, 2022
DP U-1556
9056051
May 10, 2022
DP U-1556
9073933
Mar 30, 2025
DS
9084729
May 10, 2022
DP U-1556
9161937
May 10, 2022
DP U-1556
9168252
May 10, 2022
DP U-1556
9205082
May 10, 2022
DP U-1556
NALTREXONE - VIVITROL
N 021897 001 5792477
5916598
6194006
6264987
6331317
6379703
6379704
6395304
6403114
6495164
6495166
6534092
6537586
6596316
6667061
6713090
6939033
7799345
7919499
7919499

May
May
Dec
May
Nov
Dec
May
Nov
May
May
Nov
May
Nov
Dec
May
Nov
Nov
May
Oct
Oct

02,
02,
30,
19,
12,
30,
19,
12,
02,
25,
12,
19,
12,
30,
25,
12,
12,
25,
15,
15,

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE N 021926 001 6060499

Aug 14,
6060499*PED
Feb 14,
6586458
Aug 14,
6586458*PED
Feb 14,
7332183
Oct 02,

2017
2017
2018
2020
2019
2018
2020
2019
2017
2020
2019
2020
2019
2018
2020
2019
2019
2020
2029
2029
TREXIMET

2017
2018

2017
2018

2025

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
U-1123
U-1124

DP U-867

DP U-867

DP U-867

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 151 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET
N 021926 001 7332183*PED
Apr 02, 2026
8022095
Aug 14, 2017
8022095*PED
Feb 14, 2018
APPL/PROD
NO

PATENT NO

PATENT
CODES

TREXIMET
2017
2018
2017
2018
2017
2018
2025
2026

NATEGLINIDE - STARLIX
N 021204 001 6559188
6641841
6844008
6878749

Sep
Nov
Nov
Sep

15,
14,
14,
15,

2020
2017
2017
2020

DP U-827
DP U-214
DP U-214
DP

NATEGLINIDE - STARLIX
N 021204 002 6559188
6641841
6844008
6878749

Sep
Nov
Nov
Sep

15,
14,
14,
15,

2020
2017
2017
2020

DP U-827
DP U-214
DP U-214
DP

DP U-1719

NP
PED

May 14, 2018

Nov 14, 2018

NP

Oct 16, 2015

NCE

Oct 10, 2019

NPP

Nov 08, 2015

NPP

Nov 08, 2015

DP U-1719
DP U-1719

DP U-3

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC

N 021742 003 6545040
Dec 17, 2021

DP U-3

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC

N 021742 004 6545040
Dec 17, 2021

DP U-3

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC

N 021742 005 6545040
Dec 17, 2021

DP U-3

NELARABINE - ARRANON
N 021877 001 5424295

Jun 13, 2017

DS DP

NEPAFENAC - NEVANAC
N 021862 001 7834059
8071648
8324281

Jan 31, 2027

Dec 02, 2025
Dec 02, 2025

DP
DP

NEPAFENAC - ILEVRO
N 203491 001 6403609
7947295
8921337

Jul 17, 2018

Jun 08, 2024
Mar 31, 2032

DP
DP
DP

U-1095

AKYNZEO
2020
DS
2030
U-528
2030
DP
2030
U-528

Mar 12, 2029

EXCLUSIVITY
EXPIRATION
DATE

DP U-1719

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC

N 021742 002 6545040
Dec 17, 2021

NEVIRAPINE - VIRAMUNE XR
N 201152 001 8460704

EXCLUSIVITY
CODE(S)

DP U-867

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE N 021926 002 5872145

Aug 14,
5872145*PED
Feb 14,
6060499
Aug 14,
6060499*PED
Feb 14,
6586458
Aug 14,
6586458*PED
Feb 14,
7332183
Oct 02,
7332183*PED
Apr 02,

NETUPITANT; PALONOSETRON HYDROCHLORIDE N 205718 001 6297375

Feb 22,
8623826
Nov 18,
8951969
Nov 18,
9186357
Nov 18,

PATENT
DELIST
REQUESTED

U-1409

NEVIRAPINE - VIRAMUNE XR
N 201152 002
NIACIN - NIASPAN
N 020381 001 6080428

May 27, 2017

U-331

NIACIN - NIASPAN
N 020381 002 6080428
6080428
6080428

May 27, 2017

May 27, 2017
May 27, 2017

U-331
U-1138
U-1139

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 152 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

NIACIN - NIASPAN

N 020381 002 6080428
6080428
6469035
6469035
6469035
6469035
6469035

May
May
Mar
Mar
Mar
Mar
Mar

27,
27,
15,
15,
15,
15,
15,

2017
2017
2018
2018
2018
2018
2018

U-1140

U-1141

U-768

U-1142

U-1143

U-1144

U-1145

NIACIN - NIASPAN

N 020381 003 6080428
6080428
6080428
6080428
6080428
6469035
6469035
6469035
6469035
6469035

May
May
May
May
May
Mar
Mar
Mar
Mar
Mar

27,
27,
27,
27,
27,
15,
15,
15,
15,
15,

2017
2017
2017
2017
2017
2018
2018
2018
2018
2018

U-331

U-1138

U-1139

U-1140

U-1141

U-768

U-1142

U-1143

U-1144

U-1145

NIACIN - NIASPAN

N 020381 004 6080428
6080428
6080428
6080428
6080428
6469035
6469035
6469035
6469035
6469035

May
May
May
May
May
Mar
Mar
Mar
Mar
Mar

27,
27,
27,
27,
27,
15,
15,
15,
15,
15,

2017
2017
2017
2017
2017
2018
2018
2018
2018
2018

U-331

U-1138

U-1139

U-1140

U-1141

U-768

U-1142

U-1143

U-1144

U-1145

NIACIN - NIASPAN TITRATION STARTER PACK

N 020381 005 6080428
May 27, 2017

U-331

NIACIN; SIMVASTATIN - SIMCOR

N 022078 001 6080428
6080428
6080428
6469035
6469035
6469035

May
May
May
Mar
Mar
Mar

27,
27,
27,
15,
15,
15,

2017
2017
2017
2018
2018
2018

U-862

U-1132

U-1134

U-863

U-1129

U-1149

NIACIN; SIMVASTATIN - SIMCOR

N 022078 002 6080428
6080428
6080428
6469035
6469035
6469035

May
May
May
Mar
Mar
Mar

27,
27,
27,
15,
15,
15,

2017
2017
2017
2018
2018
2018

U-862

U-1132

U-1134

U-863

U-1129

U-1149

NIACIN; SIMVASTATIN - SIMCOR

N 022078 003 6080428
6080428
6080428
6469035
6469035
6469035

May
May
May
Mar
Mar
Mar

27,
27,
27,
15,
15,
15,

2017
2017
2017
2018
2018
2018

U-862

U-1132

U-1134

U-863

U-1129

U-1149

NIACIN; SIMVASTATIN - SIMCOR

N 022078 004 6080428
6080428
6080428
6469035
6469035
6469035

May
May
May
Mar
Mar
Mar

27,
27,
27,
15,
15,
15,

2017
2017
2017
2018
2018
2018

U-862

U-1132

U-1134

U-863

U-1129

U-1149

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 153 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

NIACIN; SIMVASTATIN - SIMCOR

N 022078 005 6080428
6080428
6080428
6469035
6469035
6469035

PATENT
EXPIRATION
DATE
May
May
May
Mar
Mar
Mar

27,
27,
27,
15,
15,
15,

PATENT
CODES

2017
2017
2017
2018
2018
2018

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

U-862

U-1132

U-1134

U-863

U-1129

U-1149

NICARDIPINE HYDROCHLORIDE - CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

N 019734 002 7612102
Dec 26, 2027
DP

7659291
Apr 18, 2027
U-1029

8455524
Apr 18, 2027
U-1029

NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

N 019734 003 7612102
Dec 26, 2027
DP

7659291
Apr 18, 2027
U-1029

8455524
Apr 18, 2027
U-1029

NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

N 019734 004 7612102
Dec 26, 2027
DP

7659291
Apr 18, 2027
U-1029

8455524
Apr 18, 2027
U-1029

NICARDIPINE HYDROCHLORIDE - CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

N 019734 005 7612102
Dec 26, 2027
DP

7659291
Apr 18, 2027
U-1029

8455524
Apr 18, 2027
U-1029

NICOTINE - NICODERM CQ

N 020165 004 8075911
8663680
8999379
9205059

May
Feb
Feb
Dec

22,
13,
13,
15,

2021
2020
2020
2019

DP

DP

NICOTINE - NICODERM CQ

N 020165 005 8075911
8663680
8999379
9205059

May
Feb
Feb
Dec

22,
13,
13,
15,

2021
2020
2020
2019

DP

DP

NICOTINE - NICODERM CQ

N 020165 006 8075911
8663680
8999379
9205059

May
Feb
Feb
Dec

22,
13,
13,
15,

2021
2020
2020
2019

DP

DP

U-1686

DP

U-1686

DP

U-1686

DP

NICOTINE POLACRILEX - NICORETTE

N 018612 002 8323683
Apr 30, 2028

NICOTINE POLACRILEX - NICORETTE

N 020066 002 8323683
Apr 30, 2028

DP

NICOTINE POLACRILEX - NICORETTE

N 022360 001 8501164
Jun 14, 2029
8940772
Apr 30, 2029

DP

DP

NICOTINE POLACRILEX - NICORETTE

N 022360 002 8501164
Jun 14, 2029
8940772
Apr 30, 2029

DP

DP

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA

N 022068 001 7169791
Jul 04, 2023
8163904
Aug 23, 2028
8293756
Sep 25, 2027
8389537
Jul 18, 2026
8415363
Jul 18, 2026
8501760
Jul 18, 2026

DS DP U-836

DS DP

DP

DS DP U-1374

DS DP U-1407

DS DP

EXCLUSIVITY

EXPIRATION

DATE

ADA 154 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
MONOHYDRATE - TASIGNA
Jul 04, 2023
Aug 23, 2028
Sep 25, 2027
Jul 18, 2026
Jul 18, 2026
Jul 18, 2026

PATENT NO

NILOTINIB HYDROCHLORIDE
N 022068 002 7169791
8163904
8293756
8389537
8415363
8501760

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS DP U-836
DS DP
DP
DS DP U-1374
DS DP U-1407
DS DP

NIMODIPINE - NYMALIZE
N 203340 001
NINTEDANIB ESYLATE - OFEV
N 205832 001 6762180
7119093
7989474

Dec 10, 2020

Feb 21, 2024
Apr 06, 2024

DS DP
DS DP

NINTEDANIB ESYLATE - OFEV

N 205832 002 6762180
7119093
7989474

Dec 10, 2020

Feb 21, 2024
Apr 06, 2024

DS DP
DS DP

NITAZOXANIDE - ALINIA
N 021497 001 5968961

May 07, 2017

DP

NITAZOXANIDE - ALINIA
N 021498 001 5965590
5968961
6117894

Jul 03, 2017

May 07, 2017
May 07, 2017

NITRIC OXIDE - INOMAX

N 020845 002 5732693
5752504
6125846
6125846*PED
8282966
8291904
8293284
8431163
8431163*PED
8573209
8573209*PED
8573210
8573210*PED
8776794
8776794*PED
8776795
8776795*PED
8795741
8795741*PED
8846112
8846112*PED

Dec
Dec
May
Nov
Jun
Jan
Jun
Jun
Dec
Jan
Jul
Jan
Jul
Jan
Jul
Jan
Jul
Jun
Dec
Jun
Dec

13,
13,
16,
16,
30,
06,
30,
30,
30,
06,
06,
06,
06,
06,
06,
06,
06,
30,
30,
30,
30,

2016
2016
2017
2017
2029
2031
2029
2029
2029
2031
2031
2031
2031
2031
2031
2031
2031
2029
2029
2029
2029

DP U-1230
DP U-1230
DP U-1457

NITRIC OXIDE - INOMAX

N 020845 003 5732693
5752504
6125846
6125846*PED
8282966
8291904
8293284
8431163
8431163*PED
8573209
8573209*PED
8573210
8573210*PED
8776794
8776794*PED
8776795
8776795*PED

Dec
Dec
May
Nov
Jun
Jan
Jun
Jun
Dec
Jan
Jul
Jan
Jul
Jan
Jul
Jan
Jul

13,
13,
16,
16,
30,
06,
30,
30,
30,
06,
06,
06,
06,
06,
06,
06,
06,

2016
2016
2017
2017
2029
2031
2029
2029
2029
2031
2031
2031
2031
2031
2031
2031
2031

DP U-1230
DP U-1230
DP U-1457

ODE

May 10, 2020

NCE
ODE

Oct 15, 2019

Oct 15, 2021

NCE
ODE

Oct 15, 2019

Oct 15, 2021

M-167

Oct 09, 2018

U-1677

U-1677

U-523

U-1286
DP U-1226
U-1286
U-1286
DP
DP U-1453
DP U-1226
DP U-1226
U-1286
U-1286

U-1286
DP U-1226
U-1286
U-1286
DP
DP U-1453
DP U-1226
DP U-1226

ADA 155 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

NITRIC OXIDE - INOMAX

N 020845 003 8795741
8795741*PED
8846112
8846112*PED

PATENT
EXPIRATION
DATE
Jun
Dec
Jun
Dec

30,
30,
30,
30,

PATENT
CODES

2029
2029
2029
2029

NITROGLYCERIN - NITROLINGUAL PUMPSPRAY

N 018705 002 7872049
Mar 14, 2028

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1286
U-1286

DP U-39

NITROGLYCERIN - NITROSTAT
N 021134 001 6500456

Sep 16, 2018

NITROGLYCERIN - NITROSTAT
N 021134 002 6500456

Sep 16, 2018

NITROGLYCERIN - NITROSTAT
N 021134 003 6500456

Sep 16, 2018

NITROGLYCERIN - NITROMIST
N 021780 001 5869082

Apr 16, 2016

DP

NIZATIDINE - AXID
N 021494 001 6930119

Jul 17, 2022

DP

OCTREOTIDE ACETATE - SANDOSTATIN LAR

N 021008 001 5922338
Jul 13, 2016
5922682
Jul 13, 2016

DP
DP

OCTREOTIDE ACETATE - SANDOSTATIN LAR

N 021008 002 5922338
Jul 13, 2016
5922682
Jul 13, 2016

DP
DP

OCTREOTIDE ACETATE - SANDOSTATIN LAR

N 021008 003 5922338
Jul 13, 2016
5922682
Jul 13, 2016

DP
DP

OLANZAPINE - ZYPREXA
N 020592 001 6960577

Nov 01, 2017

U-963

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA
N 020592 002 6960577

Nov 01, 2017

U-963

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA
N 020592 003 6960577

Nov 01, 2017

U-963

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA
N 020592 004 6960577

Nov 01, 2017

U-963

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA
N 020592 005 6960577

Nov 01, 2017

U-963

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA
N 020592 006 6960577

Nov 01, 2017

U-963

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA ZYDIS

N 021086 001 6960577

Nov 01, 2017

U-964

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA ZYDIS

N 021086 002 6960577

Nov 01, 2017

U-964

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA ZYDIS

N 021086 003 6960577

Nov 01, 2017

U-964

NPP

Jul 26, 2016

OLANZAPINE - ZYPREXA ZYDIS

N 021086 004 6960577

Nov 01, 2017

U-964

NPP

Jul 26, 2016

OLANZAPINE PAMOATE - ZYPREXA RELPREVV

N 022173 001 6169084
Sep 30, 2018

DS DP U-1026

ADA 156 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N 022173 002 6169084
Sep 30, 2018

DS DP U-1026

OLANZAPINE PAMOATE - ZYPREXA RELPREVV

N 022173 003 6169084
Sep 30, 2018

DS DP U-1026

APPL/PROD
NO

PATENT NO

OLAPARIB - LYNPARZA
N 206162 001 7151102
7449464
7981889
8143241
8247416
8859562
8912187

Apr
Oct
Oct
Aug
Sep
Aug
Mar

29,
11,
11,
12,
24,
04,
12,

2022
2024
2024
2027
2028
2031
2024

OLIVE OIL; SOYBEAN OIL - CLINOLIPID 20%

N 204508 001 5840757
Nov 24, 2015

PATENT
CODES

PATENT
DELIST
REQUESTED

DS DP
DS DP
DS DP

EXCLUSIVITY
EXPIRATION
DATE

NCE
ODE

Dec 19, 2019

Dec 19, 2021

NP

Oct 03, 2016

NCE

Jul 31, 2019

NC
NCE

May 21, 2018

Jul 31, 2019

U-1634
DS
U-1634
U-1634

DP

OLMESARTAN MEDOXOMIL - BENICAR

N 021286 001 5616599
6878703

Apr 25, 2016

Nov 19, 2021

DS DP U-500
U-3

OLMESARTAN MEDOXOMIL - BENICAR

N 021286 003 5616599
6878703

Apr 25, 2016

Nov 19, 2021

DS DP U-500
U-3

OLMESARTAN MEDOXOMIL - BENICAR

N 021286 004 5616599
6878703

Apr 25, 2016

Nov 19, 2021

DS DP U-500
U-3

OLODATEROL HYDROCHLORIDE - STRIVERDI RESPIMAT

N 203108 001 5964416
Oct 04, 2016
6149054
Dec 19, 2016
6176442
Oct 04, 2016
6453795
Dec 05, 2016
6726124
Oct 04, 2016
6846413
Aug 28, 2018
6977042
Aug 28, 2018
6988496
Feb 23, 2020
7056916
Dec 07, 2023
7104470
Oct 04, 2016
7220742
May 12, 2025
7246615
May 31, 2016
7284474
Aug 26, 2024
7396341
Oct 10, 2026
7491719
Nov 10, 2023
7727984
Nov 10, 2023
7786111
Nov 10, 2023
7802568
Feb 26, 2019
7837235
Mar 13, 2028
7896264
May 26, 2025
7988001
Aug 04, 2021
8034809
May 12, 2025
8044046
Nov 10, 2023
8733341
Dec 16, 2029
9027967
Mar 31, 2027

EXCLUSIVITY
CODE(S)

DP
DP
DP
DP
DP
DP
DP
DP U-1547
DS DP
DP
DS DP U-1547
DP
DP
DP U-1547
DS DP
DS
DP
DP
DP
DP
DP
U-1547
U-1547
DP
DP

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - STIOLTO RESPIMAT

N 206756 001 5964416
Oct 04, 2016
DP
6149054
Dec 19, 2016
DP
6176442
Oct 04, 2016
DP
6453795
Dec 05, 2016
DP
6726124
Oct 04, 2016
DP
6846413
Aug 28, 2018
DP
6977042
Aug 28, 2018
DP
6988496
Feb 23, 2020
DP
7056916
Dec 07, 2023
DS DP
7104470
Oct 04, 2016
DP
7220742
May 12, 2025
DS DP U-1703
7246615
May 31, 2016
DP

ADA 157 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
PATENT
DATE
CODES
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - STIOLTO RESPIMAT
N 206756 001 7284474
Aug 26, 2024
DP
7396341
Oct 10, 2026
DP
7491719
Nov 10, 2023
DS DP
7727984
Nov 10, 2023
DS
7786111
Nov 10, 2023
DP
7802568
Feb 26, 2019
DP
7837235
Mar 13, 2028
DP
7896264
May 26, 2025
DP
7988001
Aug 04, 2021
DP
8034809
May 12, 2025
U-1702
8044046
Nov 10, 2023
U-1702
8733341
Dec 16, 2029
DP
9027967
Mar 31, 2027
DP
RE39820
Jan 30, 2018
DS DP U-1702
APPL/PROD
NO

PATENT NO

OLOPATADINE HYDROCHLORIDE - PATADAY

N 021545 001 6995186
Nov 12, 2023
7402609
Jun 19, 2022

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-765
DP

OLOPATADINE HYDROCHLORIDE - PATANASE

N 021861 001 7977376
Feb 02, 2023
8399508
Sep 17, 2022
8399508*PED
Mar 17, 2023

DP
U-726

OLOPATADINE HYDROCHLORIDE - PAZEO

N 206276 001 8791154
May 19, 2032

DP U-1680

NP
PED

Jan 30, 2018

Jul 30, 2018

OMACETAXINE MEPESUCCINATE - SYNRIBO

N 203585 001 6987103
Jun 28, 2023
RE45128
Mar 16, 2019

U-1300
DS DP U-1576

NCE
ODE

Oct 26, 2017

Oct 26, 2019

U-1635

NCE
NP

Dec 19, 2019

Jul 24, 2018

OMBITASVIR; PARITAPREVIR; RITONAVIR - TECHNIVIE

N 207931 001 6037157
Jun 26, 2016
6037157*PED
Dec 26, 2016
6703403
Jun 26, 2016
6703403*PED
Dec 26, 2016
7148359
Jul 19, 2019
7148359*PED
Jan 19, 2020
7364752
Nov 10, 2020
7364752*PED
May 10, 2021
8268349
Aug 25, 2024
8268349*PED
Feb 25, 2025
8399015
Aug 25, 2024
8399015*PED
Feb 25, 2025
8420596
Apr 10, 2031
8420596*PED
Oct 10, 2031
8642538
Sep 10, 2029
8686026
Jun 09, 2031
8691938
Apr 13, 2032
9006387
Jun 10, 2030
9044480
Apr 10, 2031
OMEGA-3-CARBOXYLIC ACIDS - EPANOVA
N 205060 001 5792795
May
5948818
May
7960370
Feb
8383678
Feb
9012501
Feb
9050308
Jan
9050309
Jan
9132112
Feb

13,
13,
07,
07,
07,
04,
04,
07,

2016
2016
2025
2025
2025
2033
2033
2025

OMEPRAZOLE - PRILOSEC
N 019810 001 6147103
6150380
6166213
6191148

09,
10,
09,
09,

2018
2018
2018
2018

Oct
Nov
Oct
Oct

U-1635
DP
DP
DP
DP
DS DP
DS DP U-1638
DP
DS DP
U-1687
U-1638

DP
DP
DP
DP U-1511
DP U-1511
U-1511
DS
DP U-1511

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 158 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT

EXPIRATION
DATE

OMEPRAZOLE - PRILOSEC

N 019810 002 6147103
6150380
6166213
6191148

Oct
Nov
Oct
Oct

09,
10,
09,
09,

2018

2018

2018

2018

OMEPRAZOLE - PRILOSEC

N 019810 003 6147103
6150380
6166213
6191148

Oct
Nov
Oct
Oct

09,
10,
09,
09,

2018

2018

2018

2018

OMEPRAZOLE - OMEPRAZOLE

N 022032 001 9023391

Aug 16, 2025

PATENT

CODES

PATENT
DELIST
REQUESTED

DP

OMEPRAZOLE MAGNESIUM - PRILOSEC OTC

N 021229 001 5817338
Oct 06, 2015

5900424
May 04, 2016

6403616
Nov 15, 2019

6428810
Nov 03, 2019

OMEPRAZOLE MAGNESIUM - PRILOSEC

N 022056 001 5900424
May 04, 2016
6428810
Nov 03, 2019

DS

U-864

DP U-864

OMEPRAZOLE MAGNESIUM - PRILOSEC

N 022056 002 5900424
May 04, 2016
6428810
Nov 03, 2019

DS

U-864

DP U-864

OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID

N 021636 001 5840737
Jul 16, 2016
6489346
Jul 16, 2016
6645988
Jul 16, 2016
6699885
Jul 16, 2016
6780882
Jul 16, 2016
7399772
Jul 16, 2016
RE45198
Jul 16, 2016

U-588

DS DP U-588

DS DP

U-588

DS DP

U-588

U-588

OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID

N 021636 002 5840737
Jul 16, 2016
5840737
Jul 16, 2016
6489346
Jul 16, 2016
6489346
Jul 16, 2016
6645988
Jul 16, 2016
6699885
Jul 16, 2016
6699885
Jul 16, 2016
6780882
Jul 16, 2016
7399772
Jul 16, 2016
7399772
Jul 16, 2016
RE45198
Jul 16, 2016

U-623

U-624

DS DP U-623

DS DP U-624

DS DP

U-623

U-624

DS DP

U-623

U-624

U-588

OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID

N 021849 001 7399772
Jul 16, 2016

U-588

OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID

N 021849 002 7399772
Jul 16, 2016

U-623

OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID OTC

N 022281 001 6489346
Jul 15, 2016
6645988
Jul 15, 2016
6699885
Jul 15, 2016
7399772
Jul 15, 2016
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID OTC

N 022283 001 5840737
Jul 15, 2016
6780882
Jul 15, 2016
7399772
Jul 15, 2016

DP U-1025

DP

DP

U-1025

U-1025

DP

U-1025

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ADA 159 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ONDANSETRON - ZOFRAN ODT

N 020781 001 5955488
6063802

Nov 14, 2015

Nov 14, 2015

ONDANSETRON - ZOFRAN ODT

N 020781 002 5955488
6063802

Nov 14, 2015

Nov 14, 2015

ONDANSETRON - ZUPLENZ
N 022524 001 8580830
9095577

Nov 23, 2029

Jul 13, 2030

DP
DP

ONDANSETRON - ZUPLENZ
N 022524 002 8580830
9095577

Nov 23, 2029

Jul 13, 2030

DP
DP

ONDANSETRON HYDROCHLORIDE - ZOFRAN

N 020605 001 5854270
Nov 20, 2015
ORITAVANCIN DIPHOSPHATE - ORBACTIV
N 206334 001 5840684
Nov 24, 2016
5998581
Nov 12, 2017
8420592
Aug 29, 2029

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-44

DS DP U-1569
DS
U-1570

NCE
GAIN

Aug 06, 2019

Aug 06, 2024

ORLISTAT - XENICAL
N 020766 001 6004996

Jan 06, 2018

ORLISTAT - ALLI
N 021887 001 6004996

Jan 06, 2018

OSELTAMIVIR PHOSPHATE - TAMIFLU

N 021087 001 5763483
5866601

Aug 23, 2016

Feb 02, 2016

DS DP U-1113
DS DP

NPP

Dec 21, 2015

OSELTAMIVIR PHOSPHATE - TAMIFLU

N 021087 002 5763483
5866601

Aug 23, 2016

Feb 02, 2016

DS DP U-1113
DS DP

NPP

Dec 21, 2015

OSELTAMIVIR PHOSPHATE - TAMIFLU

N 021087 003 5763483
5866601

Aug 23, 2016

Feb 02, 2016

DS DP U-1113
DS DP

NPP

Dec 21, 2015

OSELTAMIVIR PHOSPHATE - TAMIFLU

N 021246 001 5763483
5763483
5866601

Dec 27, 2016

Dec 27, 2016
Feb 02, 2016

DS
U-376
DS
U-1113
DS DP

NPP

Dec 21, 2015

OSELTAMIVIR PHOSPHATE - TAMIFLU

N 021246 002 5763483
5763483*PED
5866601

Aug 23, 2016

Feb 23, 2017
Feb 02, 2016

DS DP U-1113

NPP

Dec 21, 2015

OSIMERTINIB MESYLATE - TAGRISSO

N 208065 001 8946235

Aug 08, 2032

DS DP U-1777

NCE

Nov 13, 2020

OSIMERTINIB MESYLATE - TAGRISSO

N 208065 002 8946235

Aug 08, 2032

DS DP U-1777

NCE

Nov 13, 2020

OSPEMIFENE - OSPHENA
N 203505 001 6245819
8236861
8236861
8470890
8470890
8642079
8772353
8772353

Jul
Aug
Aug
Feb
Feb
Jul
Feb
Feb

U-1369
U-1369
U-1370
U-1369
U-1370

NCE

Feb 26, 2018

21,
11,
11,
13,
13,
09,
13,
13,

2020
2026
2026
2024
2024
2028
2024
2024

DP

DS DP

DP
U-1369
U-1370

ADA 160 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OXALIPLATIN - ELOXATIN
N 021492 001 5420319

Aug 09, 2016

DS

OXALIPLATIN - ELOXATIN
N 021492 002 5420319

Aug 09, 2016

DS

OXALIPLATIN - ELOXATIN
N 021759 001 5420319
5716988

Aug 09, 2016

Aug 07, 2015

DS

OXALIPLATIN - ELOXATIN
N 021759 002 5420319
5716988

Aug 09, 2016

Aug 07, 2015

DS

OXALIPLATIN - ELOXATIN
N 021759 003 5420319
5716988

Aug 09, 2016

Aug 07, 2015

DS

OXANDROLONE - OXANDRIN
N 013718 001 5872147
6090799
6576659
6828313

Dec
Jul
Dec
Dec

05,
18,
05,
05,

2017
2017
2017
2017

U-585
U-585
U-585
U-585

OXANDROLONE - OXANDRIN
N 013718 002 5872147
6090799
6576659
6828313

Dec
Jul
Dec
Dec

05,
18,
05,
05,

2017
2017
2017
2017

U-585
U-585
U-585
U-585

OXCARBAZEPINE - TRILEPTAL
N 021014 001 7037525

Feb 12, 2018

U-724

OXCARBAZEPINE - TRILEPTAL
N 021014 002 7037525

Feb 12, 2018

U-724

OXCARBAZEPINE - TRILEPTAL
N 021014 003 7037525

Feb 12, 2018

U-724

OXCARBAZEPINE - TRILEPTAL
N 021285 001 7037525
8119148

Feb 12, 2018

Dec 19, 2020

U-724
DP U-724

OXCARBAZEPINE - OXTELLAR XR
N 202810 001 7722898
7910131
8617600
8821930
9119791

Apr
Apr
Apr
Apr
Apr

13,
13,
13,
13,
13,

2027
2027
2027
2027
2027

DP

OXCARBAZEPINE - OXTELLAR XR
N 202810 002 7722898
7910131
8617600
8821930
9119791

Apr
Apr
Apr
Apr
Apr

13,
13,
13,
13,
13,

2027
2027
2027
2027
2027

DP

OXCARBAZEPINE - OXTELLAR XR
N 202810 003 7722898
7910131
8617600
8821930
9119791

Apr
Apr
Apr
Apr
Apr

13,
13,
13,
13,
13,

2027
2027
2027
2027
2027

DP

OXYBUTYNIN - OXYTROL
N 021351 002 6743441
7081249
7081250
7081251
7081252
7179483

Apr
Apr
Apr
Apr
Apr
Apr

26,
26,
26,
26,
26,
26,

2020
2020
2020
2020
2020
2020

DP
DP
DP
DP
DP
DS DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP

DP

DP

NDF

Oct 19, 2015

NDF

Oct 19, 2015

NDF

Oct 19, 2015

U-1298
DP
DP
U-1298

U-1298
DP
DP
U-1298

U-1298
DP
DP
U-1298

U-318
U-318
U-318
U-318
U-318
U-318

ADA 161 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OXYBUTYNIN - OXYTROL
N 021351 002 6743441
7081249
7081250
7081251
7081252
7179483

Apr
Apr
Apr
Apr
Apr
Apr

26,
26,
26,
26,
26,
26,

2020
2020
2020
2020
2020
2020

DP
DP
DP
DP
DP
DS DP

OXYBUTYNIN - OXYTROL FOR WOMEN

N 202211 001 6743441
7081249
7081250
7081251
7081252
7179483

Apr
Apr
Apr
Apr
Apr
Apr

26,
26,
26,
26,
26,
26,

2020
2020
2020
2020
2020
2020

DP
DP
DP
DP
DP

OXYBUTYNIN - GELNIQUE 3%
N 202513 001 7029694
7179483
7198801
8241662

Apr
Apr
Jun
Apr

26,
26,
25,
26,

2020
2020
2022
2020

DP U-318
U-318
DP
U-318

OXYBUTYNIN CHLORIDE - GELNIQUE

N 022204 001 7029694
7179483
8241662
8920392

Apr
Apr
Apr
Mar

26,
26,
26,
26,

2020
2020
2020
2031

DP U-318
U-318
U-318
U-1644

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N 022272 001 6488963
Jun
7674799
Mar
7674800
Mar
7683072
Mar
7776314
Apr
8114383
Oct
8309060
Nov
8337888
Aug
8808741
Aug
8894987
Mar
8894988
Aug
9060976
Aug
9073933
Mar

24,
30,
30,
30,
19,
10,
20,
06,
24,
29,
24,
06,
30,

2017
2025
2025
2025
2025
2024
2023
2022
2027
2030
2027
2022
2025

DP
DP

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N 022272 002 6488963
Jun
7674799
Mar
7674800
Mar
7683072
Mar
7776314
Apr
8114383
Oct
8309060
Nov
8337888
Aug
8808741
Aug
8894987
Mar
8894988
Aug
9060976
Aug
9073933
Mar

24,
30,
30,
30,
19,
10,
20,
06,
24,
29,
24,
06,
30,

2017
2025
2025
2025
2025
2024
2023
2022
2027
2030
2027
2022
2025

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N 022272 003 6488963
Jun
7674799
Mar
7674800
Mar
7683072
Mar
7776314
Apr
8114383
Oct
8309060
Nov
8337888
Aug
8808741
Aug
8894987
Mar
8894988
Aug

24,
30,
30,
30,
19,
10,
20,
06,
24,
29,
24,

2017
2025
2025
2025
2025
2024
2023
2022
2027
2030
2027

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-318
U-318
U-318
U-318
U-318
U-318

U-1329
U-1329
U-1329
U-1329
U-1329
U-1329

NP

Jan 25, 2016

M-153
NPP

Apr 16, 2016

Aug 13, 2018

M-153
NPP

Apr 16, 2016

Aug 13, 2018

M-153
NPP

Apr 16, 2016

Aug 13, 2018

DS
DS
DP
DP
DP U-1556
DP
U-1556
DP
DP
DP

DS

DP
DP
DS
DS
DP
DP
DP U-1556
DP
U-1556
DP
DP
DP

DS

DP
DP
DS
DS
DP
DP
DP U-1556
DP
U-1556
DP
DP

ADA 162 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 003 9060976
Aug 06, 2022
9073933
Mar 30, 2025
APPL/PROD
NO

PATENT NO

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N 022272 004 6488963
Jun
7674799
Mar
7674800
Mar
7683072
Mar
7776314
Apr
8114383
Oct
8309060
Nov
8337888
Aug
8808741
Aug
8894987
Mar
8894988
Aug
9060976
Aug
9073933
Mar

24,
30,
30,
30,
19,
10,
20,
06,
24,
29,
24,
06,
30,

2017
2025
2025
2025
2025
2024
2023
2022
2027
2030
2027
2022
2025

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N 022272 005 6488963
Jun
7674799
Mar
7674800
Mar
7683072
Mar
7776314
Apr
8114383
Oct
8309060
Nov
8337888
Aug
8808741
Aug
8894988
Aug
9060976
Aug
9073933
Mar

24,
30,
30,
30,
19,
10,
20,
06,
24,
24,
06,
30,

2017
2025
2025
2025
2025
2024
2023
2022
2027
2027
2022
2025

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N 022272 006 6488963
Jun
7674799
Mar
7674800
Mar
7683072
Mar
7776314
Apr
8114383
Oct
8309060
Nov
8337888
Aug
8808741
Aug
8894988
Aug
9060976
Aug
9073933
Mar

24,
30,
30,
30,
19,
10,
20,
06,
24,
24,
06,
30,

2017
2025
2025
2025
2025
2024
2023
2022
2027
2027
2022
2025

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N 022272 007 6488963
Jun
7674799
Mar
7674800
Mar
7683072
Mar
7776314
Apr
8114383
Oct
8309060
Nov
8337888
Aug
8808741
Aug
8894988
Aug
9060976
Aug
9073933
Mar

24,
30,
30,
30,
19,
10,
20,
06,
24,
24,
06,
30,

2017
2025
2025
2025
2025
2024
2023
2022
2027
2027
2022
2025

OXYCODONE HYDROCHLORIDE - OXAYDO

N 202080 001 7201920
Mar 16, 2025
7510726
Nov 26, 2023
7981439
Nov 26, 2023
8409616
Nov 26, 2023
8637540
Nov 26, 2023

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DS

DP
DP

M-153
NPP

Apr 16, 2016

Aug 13, 2018

M-153
NPP

Apr 16, 2016

Aug 13, 2018

M-153
NPP

Apr 16, 2016

Aug 13, 2018

M-153
NPP

Apr 16, 2016

Aug 13, 2018

DS
DS
DP
DP
DP U-1556
DP
U-1556
DP
DP
DP

DS

DP
DP
DS
DS
DP
DP
DP U-1556
DP
U-1556
DP
DP

DS

DP
DP
DS
DS
DP
DP
DP U-1556
DP
U-1556
DP
DP

DS

DP
DP
DS
DS
DP
DP
DP U-1556
DP
U-1556
DP
DP
DS

DP
DP
DP
DP
DP

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 163 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OXYCODONE HYDROCHLORIDE - OXAYDO

N 202080 002 7201920
Mar 16, 2025
7510726
Nov 26, 2023
7981439
Nov 26, 2023
8409616
Nov 26, 2023
8637540
Nov 26, 2023

DP
DP
DP
DP
DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 021610 001 7276250
Feb 04, 2023

DP U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 021610 002 7276250
Feb 04, 2023

DP U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 021610 003 7276250
Feb 04, 2023

DP U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 021610 004 7276250
Feb 04, 2023

DP U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 021610 005 7276250
Feb 04, 2023

DP U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 021610 006 7276250
Feb 04, 2023

DP U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 021610 007 7276250
Feb 04, 2023

DP U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 201655 001 7851482
Jul
8075872
Nov
8114383
Aug
8192722
Sep
8309060
Nov
8309122
Feb
8329216
Feb
8808737
Jun
8871779
Nov

10,
20,
08,
15,
20,
04,
04,
21,
22,

2029
2023
2024
2025
2023
2023
2023
2027
2029

DS

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 201655 002 7851482
Jul
8075872
Nov
8114383
Aug
8192722
Sep
8309060
Nov
8309122
Feb
8329216
Feb
8808737
Jun
8871779
Nov

10,
20,
08,
15,
20,
04,
04,
21,
22,

2029
2023
2024
2025
2023
2023
2023
2027
2029

DS

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 201655 003 7851482
Jul
8075872
Nov
8114383
Aug
8192722
Sep
8309060
Nov
8309122
Feb
8329216
Feb
8808737
Jun
8871779
Nov

10,
20,
08,
15,
20,
04,
04,
21,
22,

2029
2023
2024
2025
2023
2023
2023
2027
2029

DS

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 201655 004 7851482
Jul
8075872
Nov
8114383
Aug
8192722
Sep
8309060
Nov
8309122
Feb
8329216
Feb
8808737
Jun

10,
20,
08,
15,
20,
04,
04,
21,

2029
2023
2024
2025
2023
2023
2023
2027

DS

DP
DP
DP
DP
DP
DP
U-1598
DS

DP
DP
DP
DP
DP
DP
U-1598
DS

DP
DP
DP
DP
DP
DP
U-1598
DS

DP
DP
DP
DP
DP
DP
U-1598

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 164 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 004 8871779
Nov 22, 2029
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 201655 005 7851482
Jul
8075872
Nov
8114383
Aug
8192722
Sep
8309060
Nov
8309122
Feb
8329216
Feb
8808737
Jun
8871779
Nov

10,
20,
08,
15,
20,
04,
04,
21,
22,

2029
2023
2024
2025
2023
2023
2023
2027
2029

DS

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 201655 006 7851482
Jul
8075872
Nov
8114383
Aug
8192722
Sep
8309060
Nov
8309122
Feb
8329216
Feb
8808737
Jun
8871779
Nov

10,
20,
08,
15,
20,
04,
04,
21,
22,

2029
2023
2024
2025
2023
2023
2023
2027
2029

DS

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N 201655 007 7851482
Jul
8075872
Nov
8114383
Aug
8192722
Sep
8309060
Nov
8309122
Feb
8329216
Feb
8808737
Jun
8871779
Nov

10,
20,
08,
15,
20,
04,
04,
21,
22,

2029
2023
2024
2025
2023
2023
2023
2027
2029

DS

PACLITAXEL - ABRAXANE
N 021660 001 7758891
7820788
7820788
7820788
7923536
7923536
7923536
8034375
8138229
8138229
8138229
8268348
8314156
8314156
8853260
8853260
8853260
9101543
RE41884
RE41884
RE41884

Feb
Oct
Oct
Oct
Dec
Dec
Dec
Aug
Dec
Dec
Dec
Feb
Dec
Dec
Oct
Oct
Oct
Feb
Aug
Aug
Aug

21,
27,
27,
27,
09,
09,
09,
13,
09,
09,
09,
21,
09,
09,
10,
10,
10,
21,
14,
14,
14,

2026
2024
2024
2024
2023
2023
2023
2026
2023
2023
2023
2026
2023
2023
2020
2020
2020
2026
2016
2016
2016

PALBOCICLIB - IBRANCE
N 207103 001 6936612
7208489
7456168

Jan 22, 2023

Jan 16, 2023
Jan 16, 2023

DS DP
DS DP

PALBOCICLIB - IBRANCE
N 207103 002 6936612
7208489
7456168

Jan 22, 2023

Jan 16, 2023
Jan 16, 2023

DS DP
DS DP

DP
DP
DP
DP
DP
DP
U-1598
DS

DP
DP
DP
DP
DP
DP
U-1598
DS

DP
DP
DP
DP
DP
DP
U-1598
DS

U-1434
DP U-1092
DP U-1290
DP U-1434
U-1117
U-1290
U-1434
U-1290
DP U-1092
DP U-1290
DP U-1434
U-1290
U-1290
U-1434
DP U-1092
DP U-1290
DP U-1434
U-1434
U-1117
U-1290
U-1434

I-658
I-676
ODE

Oct 11, 2015

Sep 06, 2016
Sep 06, 2020

NCE

Feb 03, 2020

NCE

Feb 03, 2020

U-1658

U-1658

ADA 165 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PALBOCICLIB - IBRANCE
N 207103 003 6936612
7208489
7456168

PATENT
EXPIRATION
DATE
Jan 22, 2023
Jan 16, 2023
Jan 16, 2023

PATENT
CODES
DS DP
DS DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Feb 03, 2020

U-1658

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N 022264 001 6077843
May 12, 2017
6555544
Nov 10, 2018

DP U-543
DP U-543

I-698
M-119

Nov 12, 2017

Aug 29, 2015

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N 022264 002 6077843
May 12, 2017
6555544
Nov 10, 2018

DP U-543
DP U-543

I-698
M-119

Nov 12, 2017

Aug 29, 2015

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N 022264 003 6077843
May 12, 2017
6555544
Nov 10, 2018

DP U-543
DP U-543

I-698
M-119

Nov 12, 2017

Aug 29, 2015

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N 022264 004 6077843
May 12, 2017
6555544
Nov 10, 2018

DP U-543
DP U-543

I-698
M-119

Nov 12, 2017

Aug 29, 2015

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

N 022264 005 6077843
May 12, 2017
6555544
Nov 10, 2018

DP U-543
DP U-543

I-698
M-119

Nov 12, 2017

Aug 29, 2015

PALIPERIDONE PALMITATE - INVEGA TRINZA

N 207946 001 6077843
May 12, 2017
6077843*PED
Nov 12, 2017

DP U-543

NP

May 18, 2018

PALIPERIDONE PALMITATE - INVEGA TRINZA

N 207946 002 6077843
May 12, 2017
6077843*PED
Nov 12, 2017

DP U-543

NP

May 18, 2018

PALIPERIDONE PALMITATE - INVEGA TRINZA

N 207946 003 6077843
May 12, 2017
6077843*PED
Nov 12, 2017

DP U-543

NP

May 18, 2018

PALIPERIDONE PALMITATE - INVEGA TRINZA

N 207946 004 6077843
May 12, 2017
6077843*PED
Nov 12, 2017

DP U-543

NP

May 18, 2018

I-684
M-136
PED
PED

May
May
Nov
Nov

27,
27,
27,
27,

2017
2017
2017
2017

I-684
M-136
PED
PED

May
May
Nov
Nov

27,
27,
27,
27,

2017
2017
2017
2017

PALONOSETRON HYDROCHLORIDE - ALOXI

N 021372 001 5202333*PED
Oct
7947724
Jan
7947724*PED
Jul
7947725
Jan
7947725*PED
Jul
7960424
Jan
7960424*PED
Jul
8518981
Jan
8518981*PED
Jul
8598218
Jan
8598218*PED
Jul
8598219
Jan
8598219*PED
Jul
8729094
Jan
8729094*PED
Jul
9066980
Jan
9125905
Jan
9173942
Jan

13,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

2015
2024
2024
2024
2024
2024
2024
2024
2024
2024
2024
2024
2024
2024
2024
2024
2024
2024

PALONOSETRON HYDROCHLORIDE - ALOXI

N 021372 002 5202333*PED
Oct
7947724
Jan
7947724*PED
Jul
7947725
Jan
7947725*PED
Jul
7960424
Jan
7960424*PED
Jul
8518981
Jan

13,
30,
30,
30,
30,
30,
30,
30,

2015
2024
2024
2024
2024
2024
2024
2024

DP
DP
DP
DP
DP
DP
DP U-528
DP U-528
DP
DP

DP
DP
DP
DP

ADA 166 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
PALONOSETRON HYDROCHLORIDE - ALOXI

N 021372 002 8518981*PED
Jul 30, 2024

8598218
Jan 30, 2024
8598218*PED
Jul 30, 2024

8598219
Jan 30, 2024
8598219*PED
Jul 30, 2024

9125905
Jan 30, 2024
9173942
Jan 30, 2024
PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

DP

DP

DP

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PERTZYE

N 022175 001

NCE

May 17, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PERTZYE

N 022175 002

NCE

May 17, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) N 022210 007 8221747

Feb 20,
8562978
Feb 20,
8562979
Feb 20,
8562980
Feb 20,
8562981
Feb 20,

ZENPEP

2028
2028
2028
2028
2028

DP

DP

DP U-1274

DP U-1274

U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - CREON

N 020725 001 9198871

Feb 07, 2030
DP U-1787

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - CREON

N 020725 002 9198871

Feb 07, 2030
DP U-1787

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - CREON

N 020725 003 9198871

Feb 07, 2030
DP U-1787

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - CREON

N 020725 004 9198871

Feb 07, 2030
DP U-1787
M-93
Jul 29, 2019

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - CREON

N 020725 005 9198871

Feb 07, 2030
DP U-1787
M-93
Jul 29, 2019

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ZENPEP

N 022210 001 7658918

Feb 20, 2028
DP

8221747
Feb 20, 2028
DP

8246950
Feb 20, 2028
U-1274

8562978
Feb 20, 2028
DP

8562979
Feb 20, 2028
DP U-1274

8562980
Feb 20, 2028
DP U-1274

8562981
Feb 20, 2028
U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ZENPEP

N 022210 002 7658918

Feb 20, 2028
DP

8221747
Feb 20, 2028
DP

8246950
Feb 20, 2028
U-1274

8562978
Feb 20, 2028
DP

8562979
Feb 20, 2028
DP U-1274

8562980
Feb 20, 2028
DP U-1274

8562981
Feb 20, 2028
U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ZENPEP

N 022210 003 7658918

Feb 20, 2028
DP

8221747
Feb 20, 2028
DP

8246950
Feb 20, 2028
U-1274

8562978
Feb 20, 2028
DP

8562979
Feb 20, 2028
DP U-1274

8562980
Feb 20, 2028
DP U-1274

8562981
Feb 20, 2028

ADA 167 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
PATENT
EXCLUSIVITY

EXPIRATION
DELIST
EXPIRATION

PATENT
EXCLUSIVITY
DATE
REQUESTED
DATE

CODES
CODE(S)
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ZENPEP

N 022210 004 7658918

Feb 20, 2028
DP

8221747
Feb 20, 2028
DP

8246950
Feb 20, 2028
U-1274

8562978
Feb 20, 2028
DP

8562979
Feb 20, 2028
DP U-1274

8562980
Feb 20, 2028
DP U-1274

8562981
Feb 20, 2028
U-1274

PATENT NO

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ZENPEP

N 022210 005 8221747

Feb 20, 2028
DP

8562978
Feb 20, 2028
DP

8562979
Feb 20, 2028
DP U-1274

8562980
Feb 20, 2028
DP U-1274

8562981
Feb 20, 2028
U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ZENPEP

N 022210 006 8221747

Feb 20, 2028
DP

8562978
Feb 20, 2028
DP

8562979
Feb 20, 2028
DP U-1274

8562980
Feb 20, 2028
DP U-1274

8562981
Feb 20, 2028
U-1274

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ULTRESA

N 022222 001
NCE
Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ULTRESA

N 022222 002
NCE
Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - ULTRESA

N 022222 003
NCE
Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - VIOKACE

N 022542 001
NCE
Mar 01, 2017

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE

(AMYLASE;LIPASE;PROTEASE) - VIOKACE

N 022542 002
NCE
Mar 01, 2017

PANOBINOSTAT LACTATE - FARYDAK

N 205353 001 6552065
6833384
7067551
7989494
8883842

Aug
Sep
Aug
Jan
Jun

31,
30,
31,
17,
13,

2021
2021
2021
2028
2028

DS DP
DS DP U-1669
U-1669

DS DP

U-1669

NCE
ODE

Feb 23, 2020

Feb 23, 2022

PANOBINOSTAT LACTATE - FARYDAK

N 205353 002 6552065
6833384
7067551
7989494
8883842

Aug
Sep
Aug
Jan
Jun

31,
30,
31,
17,
13,

2021
2021
2021
2028
2028

DS DP
DS DP U-1669
U-1669

DS DP

U-1669

NCE
ODE

Feb 23, 2020

Feb 23, 2022

PANOBINOSTAT LACTATE - FARYDAK

N 205353 003 6552065
6833384
7067551
7989494
8883842

Aug
Sep
Aug
Jan
Jun

31,
30,
31,
17,
13,

2021
2021
2021
2028
2028

DS DP
DS DP U-1669
U-1669

DS DP

U-1669

NCE
ODE

Feb 23, 2020

Feb 23, 2022

PANTOPRAZOLE SODIUM - PROTONIX

N 020987 001 5997903

Dec 07, 2016

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 168 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PANTOPRAZOLE SODIUM - PROTONIX

N 020987 002 5997903

PATENT
EXPIRATION
DATE

PATENT
CODES

Dec 07, 2016

PANTOPRAZOLE SODIUM - PROTONIX IV

N 020988 001 6780881
Nov
7351723
Nov
8754108
Nov
8754108*PED
May

17,
17,
17,
17,

2021
2021
2021
2022

DP

DP

DP

PANTOPRAZOLE SODIUM - PROTONIX

N 022020 001 7544370
7550153
7553498
7838027

Jun
Sep
Sep
Sep

07,
30,
30,
30,

2026
2024
2024
2024

DP

PARICALCITOL - ZEMPLAR

N 020819 001 5597815
6136799
6361758

Jul 13, 2015

Apr 08, 2018

Apr 08, 2018

PARICALCITOL - ZEMPLAR

N 020819 002 5597815
6136799
6361758

Jul 13, 2015

Apr 08, 2018

Apr 08, 2018

PARICALCITOL - ZEMPLAR

N 020819 003 5597815
5597815*PED
6136799
6136799*PED
6361758
6361758*PED

Jul
Jan
Apr
Oct
Apr
Oct

PARICALCITOL - ZEMPLAR

N 021606 001 5597815

Jul 13, 2015

U-1195

PARICALCITOL - ZEMPLAR

N 021606 002 5597815

Jul 13, 2015

U-1195

PARICALCITOL - ZEMPLAR

N 021606 003 5597815

Jul 13, 2015

U-1195

13,
13,
08,
08,
08,
08,

2015
2016

2018

2018

2018
2018

U-859

U-859

DP U-859

U-1195

DP

U-1195

DP

U-1195

DP

PAROXETINE HYDROCHLORIDE - PAXIL

N 020031 001 6121291
Mar 17, 2017
6121291
Mar 17, 2017

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL

N 020031 002 6121291
Mar 17, 2017
6121291
Mar 17, 2017

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL

N 020031 003 6121291
Mar 17, 2017
6121291
Mar 17, 2017

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL

N 020031 004 6121291
Mar 17, 2017
6121291
Mar 17, 2017

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL

N 020031 005 6121291
Mar 17, 2017
6121291
Mar 17, 2017

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL

N 020710 001 5811436
Sep 22, 2015

6121291
Mar 17, 2017
6121291
Mar 17, 2017

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL

N 020885 001 6063927
Apr 23, 2019

6121291
Mar 17, 2017
6121291
Mar 17, 2017

U-286

U-431

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ADA 169 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PAROXETINE HYDROCHLORIDE - PAXIL

N 020885 001 6172233
Jan 15, 2018

PAROXETINE HYDROCHLORIDE - PAXIL

N 020885 002 6063927
Apr
6121291
Mar
6121291
Mar
6172233
Jan

23,
17,
17,
15,

2019

2017
2017
2018

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL

N 020885 003 6063927
Apr
6121291
Mar
6121291
Mar
6172233
Jan

23,
17,
17,
15,

2019

2017
2017
2018

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL

N 020885 004 6063927
Apr
6121291
Mar
6121291
Mar
6172233
Jan

23,
17,
17,
15,

2019

2017
2017
2018

U-286

U-431

PAROXETINE HYDROCHLORIDE - PAXIL CR

N 020936 001 6121291
Mar 17, 2017
6548084
Jul 19, 2016

7229640
Jul 19, 2016
PAROXETINE HYDROCHLORIDE - PAXIL CR

N 020936 002 6121291
Mar 17, 2017
6548084
Jul 19, 2016

7229640
Jul 19, 2016
PAROXETINE HYDROCHLORIDE - PAXIL CR

N 020936 003 6121291
Mar 17, 2017
6548084
Jul 19, 2016

7229640
Jul 19, 2016

U-286

DP U-816

U-286

DP U-816

U-286

DP U-816

PAROXETINE MESYLATE - PEXEVA

N 021299 001 5874447
5874447
5874447
7598271

Jun
Jun
Jun
Feb

10,
10,
10,
12,

2017
2017
2017
2023

PAROXETINE MESYLATE - PEXEVA

N 021299 002 5874447
5874447
5874447
7598271

Jun
Jun
Jun
Feb

10,
10,
10,
12,

2017
2017
2017
2023

PAROXETINE MESYLATE - PEXEVA

N 021299 003 5874447
5874447
5874447
7598271

Jun
Jun
Jun
Feb

10,
10,
10,
12,

2017
2017
2017
2023

PAROXETINE MESYLATE - PEXEVA

N 021299 004 5874447
5874447
5874447
7598271

Jun
Jun
Jun
Feb

10,
10,
10,
12,

2017
2017
2017
2023

DS DP

PAROXETINE MESYLATE - BRISDELLE

N 204516 001 5874447
7598271
8658663
8946251

Jun
Feb
Apr
Aug

10,
12,
06,
04,

2017
2023
2029
2026

DS
DS

DS DP U-904

DS DP U-904

NP

Jun 28, 2016

DS DP
DS DP
DS DP

NCE
ODE

Dec 14, 2017

Dec 14, 2019

PASIREOTIDE DIASPARTATE - SIGNIFOR

N 200677 001 6225284
Jun 28, 2016
7473761
Jul 29, 2025
8299209
Dec 27, 2025

U-46

U-286

U-518

DS DP

U-46

U-286

U-518

DS DP

U-46

U-286

U-518

DS DP

U-46

U-286

U-518

ADA 170 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
PASIREOTIDE DIASPARTATE - SIGNIFOR
N 200677 002 6225284
Jun 28, 2016
7473761
Jul 29, 2025
8299209
Dec 27, 2025

DS DP
DS DP
DS DP

NCE
ODE

Dec 14, 2017

Dec 14, 2019

PASIREOTIDE DIASPARTATE - SIGNIFOR

N 200677 003 6225284
Jun 28, 2016
7473761
Jul 29, 2025
8299209
Dec 27, 2025

DS DP
DS DP
DS DP

NCE
ODE

Dec 14, 2017

Dec 14, 2019

PASIREOTIDE PAMOATE - SIGNIFOR LAR

N 203255 001 6225284
Jun
7473761
Jul
7759308
Oct
8822637
Aug

28,
29,
25,
06,

2016
2025
2026
2023

DS DP U-1628
DS DP
DP
U-1629

NCE
NP
ODE

Dec 14, 2017

Dec 15, 2017
Dec 15, 2021

PASIREOTIDE PAMOATE - SIGNIFOR LAR

N 203255 002 6225284
Jun
7473761
Jul
7759308
Oct
8822637
Aug

28,
29,
25,
06,

2016
2025
2026
2023

DS DP U-1628
DS DP
DP
U-1629

NCE
NP
ODE

Dec 14, 2017

Dec 15, 2017
Dec 15, 2021

PASIREOTIDE PAMOATE - SIGNIFOR LAR

N 203255 003 6225284
Jun
7473761
Jul
7759308
Oct
8822637
Aug

28,
29,
25,
06,

2016
2025
2026
2023

DS DP U-1628
DS DP
DP
U-1629

NCE
NP
ODE

Dec 14, 2017

Dec 15, 2017
Dec 15, 2021

PATIROMER SORBITEX CALCIUM - VELTASSA

N 205739 001 7556799
Feb 27,
8147873
Mar 11,
8216560
Mar 14,
8282913
Mar 11,
8287847
Mar 30,
8337824
May 29,
8475780
Mar 30,
8778324
Mar 30,
8889115
Mar 30,

2025
2026
2027
2026
2024
2030
2024
2024
2024

U-1766

NCE

Oct 21, 2020

PATIROMER SORBITEX CALCIUM - VELTASSA

N 205739 002 7556799
Feb 27,
8147873
Mar 11,
8216560
Mar 14,
8282913
Mar 11,
8287847
Mar 30,
8337824
May 29,
8475780
Mar 30,
8778324
Mar 30,
8889115
Mar 30,

2025
2026
2027
2026
2024
2030
2024
2024
2024

NCE

Oct 21, 2020

PATIROMER SORBITEX CALCIUM - VELTASSA

N 205739 003 7556799
Feb 27,
8147873
Mar 11,
8216560
Mar 14,
8282913
Mar 11,
8287847
Mar 30,
8337824
May 29,
8475780
Mar 30,
8778324
Mar 30,
8889115
Mar 30,

2025
2026
2027
2026
2024
2030
2024
2024
2024

NCE

Oct 21, 2020

APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
U-1766
DP
U-1766
U-1766
U-1766
U-1766
U-1766

DS

U-1766
DP
U-1766
DP
U-1766
U-1766
U-1766
U-1766
U-1766

DS

U-1766
DP
U-1766
DP
DS

U-1766
U-1766
U-1766
U-1766
U-1766

PAZOPANIB HYDROCHLORIDE - VOTRIENT

N 022465 001 7105530
Oct 19, 2023
7262203
Dec 19, 2021
8114885
Dec 19, 2021

DS DP
DS DP
DS DP

ODE

Apr 26, 2019

PAZOPANIB HYDROCHLORIDE - VOTRIENT

N 022465 002 7105530
Oct 19, 2023
7262203
Dec 19, 2021
8114885
Dec 19, 2021

DS DP
DS DP
DS DP

ODE

Apr 26, 2019

ADA 171 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
PAZOPANIB HYDROCHLORIDE - VOTRIENT
N 022465 002 7105530
Oct 19, 2023
7262203
Dec 19, 2021
8114885
Dec 19, 2021

DS DP
DS DP
DS DP

PEGAPTANIB SODIUM - MACUGEN

N 021756 001 5932462
6011020

DS
DS

APPL/PROD
NO

PATENT NO

Aug 03, 2016

Jan 04, 2017

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ODE

Apr 26, 2019

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N 202799 001 7084245
May 12, 2024
7414105
May 12, 2024
7528104
May 12, 2024
7550433
Jun 02, 2026
7919118
May 12, 2024
7919461
Jun 02, 2026

DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238

NCE

Mar 27, 2017

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N 202799 002 7084245
May 12, 2024
7414105
May 12, 2024
7528104
May 12, 2024
7550433
Jun 02, 2026
7919118
May 12, 2024
7919461
Jun 02, 2026

DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238

NCE

Mar 27, 2017

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N 202799 003 7084245
May 12, 2024
7414105
May 12, 2024
7528104
May 12, 2024
7550433
Jun 02, 2026
7919118
May 12, 2024
7919461
Jun 02, 2026

DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238

NCE

Mar 27, 2017

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N 202799 004 7084245
May 12, 2024
7414105
May 12, 2024
7528104
May 12, 2024
7550433
Jun 02, 2026
7919118
May 12, 2024
7919461
Jun 02, 2026

DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238

NCE

Mar 27, 2017

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N 202799 005 7084245
May 12, 2024
7414105
May 12, 2024
7528104
May 12, 2024
7550433
Jun 02, 2026
7919118
May 12, 2024
7919461
Jun 02, 2026

DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238

NCE

Mar 27, 2017

PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE

N 202799 006 7084245
May 12, 2024
7414105
May 12, 2024
7528104
May 12, 2024
7550433
Jun 02, 2026
7919118
May 12, 2024
7919461
Jun 02, 2026

DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238

NCE

Mar 27, 2017

PEGINESATIDE ACETATE - OMONTYS

N 202799 007 7084245
7414105
7528104
7550433
7919118
7919461

May
May
May
Jun
May
Jun

12,
12,
12,
02,
12,
02,

2024
2024
2024
2026
2024
2026

DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238

PEGINESATIDE ACETATE - OMONTYS

N 202799 008 7084245
7414105
7528104
7550433

May
May
May
Jun

12,
12,
12,
02,

2024
2024
2024
2026

DS DP U-1238
DS DP U-1238
DS DP
U-1238

ADA 172 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PEGINESATIDE ACETATE - OMONTYS

N 202799 008 7919118
7919461

May 12, 2024

Jun 02, 2026

DS DP

PEGVISOMANT - SOMAVERT
N 021106 001 5849535
6057292

Mar 25, 2017

Sep 21, 2015

DS

PEGVISOMANT - SOMAVERT
N 021106 002 5849535
6057292

Mar 25, 2017

Sep 21, 2015

DS

PEGVISOMANT - SOMAVERT
N 021106 003 5849535
6057292

Mar 25, 2017

Sep 21, 2015

DS

PEGVISOMANT - SOMAVERT
N 021106 004 5849535
6057292

Mar 25, 2017

Sep 21, 2015

DS

PEGVISOMANT - SOMAVERT
N 021106 005 5849535
6057292

Mar 25, 2017

Sep 21, 2015

DS

PEMETREXED DISODIUM - ALIMTA

N 021462 001 5344932
7772209
7772209

Jul 24, 2016

Nov 24, 2021
Nov 24, 2021

DS DP

PEMETREXED DISODIUM - ALIMTA

N 021462 002 5344932
7772209

Jul 24, 2016

Nov 24, 2021

DS DP

PENCICLOVIR SODIUM - DENAVIR

N 020629 001 5840763
5916893
6469015
6579981

Sep
Sep
Oct
Jun

PERAMIVIR - RAPIVAB
N 206426 001 6503745
6562861
8778997

Nov 05, 2019

Dec 17, 2018
May 07, 2027

DS
DS

PERAMPANEL - FYCOMPA
N 202834 001 6949571
8772497

Jun 08, 2021

May 16, 2026

PERAMPANEL - FYCOMPA
N 202834 002 6949571
8772497

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1238

U-507

U-507

U-507

U-507

U-507

M-122

Oct 17, 2015

M-122

Oct 17, 2015

NCE

Dec 19, 2019

DS DP U-106
DS

I-710
NCE

Jun 19, 2018

Oct 22, 2017

Jun 08, 2021

May 16, 2026

DS DP U-106
DS

I-710
NCE

Jun 19, 2018

Oct 22, 2017

PERAMPANEL - FYCOMPA
N 202834 003 6949571
8772497

Jun 08, 2021

May 16, 2026

DS DP U-106
DS

I-710
NCE

Jun 19, 2018

Oct 22, 2017

PERAMPANEL - FYCOMPA
N 202834 004 6949571
8772497

Jun 08, 2021

May 16, 2026

DS DP U-106
DS

I-710
NCE

Jun 19, 2018

Oct 22, 2017

PERAMPANEL - FYCOMPA
N 202834 005 6949571
8772497

Jun 08, 2021

May 16, 2026

DS DP U-106
DS

I-710
NCE

Jun 19, 2018

Oct 22, 2017

PERAMPANEL - FYCOMPA
N 202834 006 6949571
8772497

Jun 08, 2021

May 16, 2026

DS DP U-106
DS

I-710
NCE

Jun 19, 2018

Oct 22, 2017

01,
01,
22,
17,

U-1077
U-1296

U-1296

2015
2015
2019
2020

U-501
U-501
U-501
U-501

U-1627

ADA 173 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PERFLUTREN - DEFINITY
N 021064 001 6033645
8658205
8685441

PATENT
EXPIRATION
DATE
Jun 19, 2016
Apr 20, 2019
Jan 13, 2019

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-665
DP
U-665

PHENTERMINE HYDROCHLORIDE - SUPRENZA

N 202088 001 6149938
Jul 23, 2018
8440170
Mar 14, 2029

DP
DP

PHENTERMINE HYDROCHLORIDE - SUPRENZA

N 202088 002 6149938
Jul 23, 2018
8440170
Mar 14, 2029

DP
DP

PHENTERMINE HYDROCHLORIDE - SUPRENZA

N 202088 003 6149938
Jul 23, 2018
8440170
Mar 14, 2029

DP U-1243
DP

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA

N 022580 001 6071537
Jun 23, 2017
7056890
Jun 14, 2020
7553818
Jun 14, 2020
7659256
Jun 14, 2020
7674776
Jun 14, 2020
8580298
May 15, 2029
8580299
Jun 14, 2029
8895057
Jun 09, 2028
8895058
Jun 09, 2028
9011905
Jun 09, 2028
9011906
Jun 09, 2028

U-1262
DP U-1262
U-1262
DP U-1262
DP U-1262
DP
U-1262
U-1262
DP
DP
U-1262

NC

Jul 17, 2015

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA

N 022580 002 6071537
Jun 23, 2017
7056890
Jun 14, 2020
7553818
Jun 14, 2020
7659256
Jun 14, 2020
7674776
Jun 14, 2020
8580298
May 15, 2029
8580299
Jun 14, 2029
8895057
Jun 09, 2028
8895058
Jun 09, 2028
9011905
Jun 09, 2028
9011906
Jun 09, 2028

U-1262
DP U-1262
U-1262
DP U-1262
DP U-1262
DP
U-1262
U-1262
DP
DP
U-1262

NC

Jul 17, 2015

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA

N 022580 003 6071537
Jun 23, 2017
7056890
Jun 14, 2020
7553818
Jun 14, 2020
7659256
Jun 14, 2020
7674776
Jun 14, 2020
8580298
May 15, 2029
8580299
Jun 14, 2029
8895057
Jun 09, 2028
8895058
Jun 09, 2028
9011905
Jun 09, 2028
9011906
Jun 09, 2028

U-1262
DP U-1262
U-1262
DP U-1262
DP U-1262
DP
U-1262
U-1262
DP
DP
U-1262

NC

Jul 17, 2015

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA

N 022580 004 6071537
Jun 23, 2017
7056890
Jun 14, 2020
7553818
Jun 14, 2020
7659256
Jun 14, 2020
7674776
Jun 14, 2020
8580298
May 15, 2029
8580299
Jun 14, 2029
8895057
Jun 09, 2028
8895058
Jun 09, 2028
9011905
Jun 09, 2028
9011906
Jun 09, 2028

U-1262
DP U-1262
U-1262
DP U-1262
DP U-1262
DP
U-1262
U-1262
DP
DP
U-1262

NC

Jul 17, 2015

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 174 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PHENTOLAMINE MESYLATE - ORAVERSE

N 022159 001 6764678
May
6872390
May
7229630
Jun
7569230
Oct
7575757
Apr

11,
11,
20,
17,
21,

2021
2021
2023
2023
2025

PATENT
CODES
U-967

DP

DP

U-967

DP

PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE

N 203510 001 8859623
Nov 14, 2033
U-1594

PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE

N 203510 002 8859623
Nov 14, 2033
U-1594

PIMECROLIMUS - ELIDEL

N 021302 001 5912238
6352998
6423722

Jun 15, 2016

Oct 26, 2015

Jun 26, 2018

PIOGLITAZONE HYDROCHLORIDE - ACTOS

N 021073 001 5965584
Jun
6150383
Jun
6150384
Jun
6166042
Jun
6166043
Jun
6172090
Jun
6211205
Jun
6271243
Jun
6303640
Aug
6329404
Jun

19,
19,
19,
19,
19,
19,
19,
19,
09,
19,

2016
2016
2016
2016
2016
2016
2016
2016
2016
2016

U-753

U-418

U-419

U-414

U-415

U-416

U-410

U-411

U-425

U-753

PIOGLITAZONE HYDROCHLORIDE - ACTOS

N 021073 002 5965584
Jun
6150383
Jun
6150384
Jun
6166042
Jun
6166043
Jun
6172090
Jun
6211205
Jun
6271243
Jun
6303640
Aug
6329404
Jun

19,
19,
19,
19,
19,
19,
19,
19,
09,
19,

2016
2016
2016
2016
2016
2016
2016
2016
2016
2016

U-753

U-418

U-419

U-414

U-415

U-416

U-410

U-411

U-425

U-753

PIOGLITAZONE HYDROCHLORIDE - ACTOS

N 021073 003 5965584
Jun
6150383
Jun
6150384
Jun
6166042
Jun
6166043
Jun
6172090
Jun
6211205
Jun
6271243
Jun
6303640
Aug
6329404
Jun

19,
19,
19,
19,
19,
19,
19,
19,
09,
19,

2016
2016
2016
2016
2016
2016
2016
2016
2016
2016

U-753

U-418

U-419

U-414

U-415

U-416

U-410

U-411

U-425

U-753

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM N 050684 001 6900184

Apr 14,
7915229
Apr 14,
8133883
Apr 14,

ZOSYN

2023
2023
2023

DP U-282

DP

DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM N 050684 002 6900184

Apr 14,
7915229
Apr 14,
8133883
Apr 14,

ZOSYN

2023
2023
2023

DP U-282

DP

DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM N 050684 003 6900184

Apr 14,
7915229
Apr 14,
8133883
Apr 14,

ZOSYN

2023
2023
2023

DP U-282

DP

DP U-282

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ADA 175 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N 050684 004 6900184
Apr 14, 2023
7915229
Apr 14, 2023
8133883
Apr 14, 2023
PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP U-282

DP

DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM N 050750 001 6207661

Feb 22,
6900184
Apr 14,
7915229
Apr 14,
8133883
Apr 14,

ZOSYN IN PLASTIC CONTAINER

2019
DP

2023
DP U-282

2023
DP

2023
DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM N 050750 002 6207661

Feb 22,
6900184
Apr 14,
7915229
Apr 14,
8133883
Apr 14,

ZOSYN IN PLASTIC CONTAINER

2019
DP

2023
DP U-282

2023
DP

2023
DP U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM N 050750 003 6207661

Feb 22,
6900184
Apr 14,
7915229
Apr 14,
8133883
Apr 14,

ZOSYN IN PLASTIC CONTAINER

2019
DP

2023
DP U-282

2023
DP

2023
DP U-282

PIRFENIDONE - ESBRIET

N 022535 001 7566729
7635707
7696236
7767225
7767700
7816383
7910610
7988994
8013002
8084475
8318780
8383150
8420674
8592462
8609701
8648098
8753679
8754109
8778947

Apr
Apr
Dec
Sep
Dec
Jan
Jan
Sep
Jan
Jan
Jan
Sep
Dec
Apr
Apr
Jan
Sep
Jan
Aug

22,
22,
18,
22,
18,
08,
08,
22,
08,
08,
08,
22,
18,
22,
22,
08,
22,
08,
30,

2029
2029
2027
2026
2027
2030
2030
2026
2030
2030
2030
2026
2027
2029
2029
2030
2026
2030
2033

PITAVASTATIN CALCIUM - LIVALO

N 022363 001 5854259
5856336
6465477
7022713
8557993

Dec
Dec
Dec
Feb
Feb

29,
25,
20,
19,
02,

2015
2020
2016
2024
2024

PITAVASTATIN CALCIUM - LIVALO

N 022363 002 5854259
5856336
6465477
7022713
8557993

Dec
Dec
Dec
Feb
Feb

29,
25,
20,
19,
02,

2015
2020
2016
2024
2024

PITAVASTATIN CALCIUM - LIVALO

N 022363 003 5854259
5856336
6465477
7022713
8557993

Dec
Dec
Dec
Feb
Feb

29,
25,
20,
19,
02,

2015
2020
2016
2024
2024

PLERIXAFOR - MOZOBIL

N 022311 001 6987102
7897590
RE42152

Jul 22, 2023

Jul 22, 2023
Dec 10, 2018

DP

DP

DP
DP

DP

U-1600
U-1609
U-1601

U-1602

U-1601

U-1603

U-1604

U-1602

U-1603

U-1605

U-1606

U-1607

U-1608

U-1609

U-1610

U-1611

U-1602

U-1612

U-1613

NCE
ODE

Oct 16, 2019

Oct 15, 2021

ODE

Dec 15, 2015

DP

DS

U-998

DP

U-998

DP

DP

DS

U-998

DP

U-998

DP

DP

DS

U-998

DP

U-998

DS DP

U-936
U-936

DP

ADA 176 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

POLIDOCANOL - VARITHENA

N 205098 001 6572873
6846412
6942165
7025290
7357336
7604185
7731986
7814943
7842282
7842283
8122917
8323677
8734833
RE40640

May
Jul
May
May
May
May
Nov
Nov
May
May
Sep
May
May
Oct

26,
19,
26,
26,
26,
26,
17,
19,
26,
26,
09,
26,
26,
14,

2020
2022
2020
2020
2020
2020
2024
2027
2020
2020
2024
2020
2020
2016

U-1461

DP

DP

DP U-1461

U-1461

DS DP U-1462

DS DP U-1463

DP U-1461

U-1461

DP

DP

DS

DS DP

DS DP U-1462

POMALIDOMIDE - POMALYST

N 204026 001 5635517
6045501
6315720
6316471
6476052
6561976
6561977
6755784
6908432
8158653
8198262
8204763
8315886
8589188
8626531
8673939
8735428
8828427

Jul
Aug
Oct
Aug
Jul
Aug
Oct
Oct
Aug
Aug
Oct
Aug
Oct
Aug
Oct
May
May
Jun

24,
28,
23,
10,
24,
28,
23,
23,
28,
10,
19,
28,
23,
28,
23,
15,
15,
21,

2016
2018
2020
2016
2016
2018
2020
2020
2018
2016
2024
2018
2020
2018
2020
2023
2023
2031

U-1359
U-1361
U-1361
DP U-1360

DP U-1360

U-1361

U-1361

U-1361

U-1361

DP

U-1360

U-1361

U-1361

U-1361

U-1361

U-1360

U-1360

DS DP

I-707
NCE
ODE

Apr 23, 2018

Feb 08, 2018

Feb 08, 2020

POMALIDOMIDE - POMALYST

N 204026 002 5635517
6045501
6315720
6316471
6476052
6561976
6561977
6755784
6908432
8158653
8198262
8204763
8315886
8589188
8626531
8673939
8735428
8828427

Jul
Aug
Oct
Aug
Jul
Aug
Oct
Oct
Aug
Aug
Oct
Aug
Oct
Aug
Oct
May
May
Jun

24,
28,
23,
10,
24,
28,
23,
23,
28,
10,
19,
28,
23,
28,
23,
15,
15,
21,

2016
2018
2020
2016
2016
2018
2020
2020
2018
2016
2024
2018
2020
2018
2020
2023
2023
2031

U-1359
U-1361
U-1361
DP U-1360

DP U-1360

U-1361

U-1361

U-1361

U-1361

DP

U-1360

U-1361

U-1361

U-1361

U-1361

U-1360

U-1360

DS DP

I-707
NCE
ODE

Apr 23, 2018

Feb 08, 2018

Feb 08, 2020

POMALIDOMIDE - POMALYST

N 204026 003 5635517
6045501
6315720
6316471
6476052
6561976
6561977
6755784
6908432
8158653
8198262
8204763
8315886

Jul
Aug
Oct
Aug
Jul
Aug
Oct
Oct
Aug
Aug
Oct
Aug
Oct

24,
28,
23,
10,
24,
28,
23,
23,
28,
10,
19,
28,
23,

2016
2018
2020
2016
2016
2018
2020
2020
2018
2016
2024
2018
2020

U-1359
U-1361
U-1361
DP U-1360

DP U-1360

U-1361

U-1361

U-1361

U-1361

DP

U-1360

U-1361

U-1361

I-707
NCE
ODE

Apr 23, 2018

Feb 08, 2018

Feb 08, 2020

ADA 177 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

POMALIDOMIDE - POMALYST

N 204026 003 8589188
8626531
8673939
8735428
8828427

Aug
Oct
May
May
Jun

28,
23,
15,
15,
21,

2018
2020
2023
2023
2031

DS DP

POMALIDOMIDE - POMALYST

N 204026 004 5635517
6045501
6315720
6316471
6476052
6561976
6561977
6755784
6908432
8158653
8198262
8204763
8315886
8589188
8626531
8673939
8735428
8828427

Jul
Aug
Oct
Aug
Jul
Aug
Oct
Oct
Aug
Aug
Oct
Aug
Oct
Aug
Oct
May
May
Jun

24,
28,
23,
10,
24,
28,
23,
23,
28,
10,
19,
28,
23,
28,
23,
15,
15,
21,

2016
2018
2020
2016
2016
2018
2020
2020
2018
2016
2024
2018
2020
2018
2020
2023
2023
2031

U-1359
U-1361
U-1361
DP U-1360

DP U-1360

U-1361

U-1361

U-1361

U-1361

DP

U-1360

U-1361

U-1361

U-1361

U-1361

U-1360

U-1360

DS DP

I-707
NCE
ODE

Apr 23, 2018

Feb 08, 2018

Feb 08, 2020

PONATINIB HYDROCHLORIDE - ICLUSIG

N 203469 001 8114874
Dec
9029533
Dec
9029533
Dec
9029533
Dec
9029533
Dec
9029533
Dec

22,
22,
22,
22,
22,
22,

2026
2026
2026
2026
2026
2026

DS DP

NCE
ODE

Dec 14, 2017

Dec 14, 2019

PONATINIB HYDROCHLORIDE - ICLUSIG

N 203469 002 8114874
Dec
9029533
Dec
9029533
Dec
9029533
Dec
9029533
Dec
9029533
Dec

22,
22,
22,
22,
22,
22,

2026
2026
2026
2026
2026
2026

DS DP

NCE
ODE

Dec 14, 2017

Dec 14, 2019

PONATINIB HYDROCHLORIDE - ICLUSIG

N 203469 003 9029533
Dec
9029533
Dec
9029533
Dec
9029533
Dec
9029533
Dec

22,
22,
22,
22,
22,

2026
2026
2026
2026
2026

ODE

Sep 24, 2016

U-1361

U-1361

U-1360

U-1360

U-836
U-1283

U-1699

U-1700

U-1701

U-836
U-1283

U-1699

U-1700

U-1701

U-836

U-1283

U-1699

U-1700

U-1701

POSACONAZOLE - NOXAFIL

N 022003 001 5661151
6958337
8263600

Jul 19, 2019

Oct 05, 2018
Apr 01, 2022

DS DP U-760

DS DP U-760

DP

POSACONAZOLE - NOXAFIL

N 205053 001 5661151

Jul 19, 2019

DS DP U-1454

POSACONAZOLE - NOXAFIL

N 205596 001 5661151
8410077
9023790

Jul 19, 2019

Mar 13, 2029
Jul 04, 2031

DS DP U-1454

DP

DP U-1698

PRALATREXATE - FOLOTYN

N 022468 001 6028071
7622470
8299078

Jul 16, 2022

May 31, 2025
May 31, 2025

DS DP U-1004
U-1015

U-1004

ADA 178 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PRALATREXATE - FOLOTYN

N 022468 002 6028071
7622470
8299078

PATENT
EXPIRATION
DATE
Jul 16, 2022
May 31, 2025
May 31, 2025

PATENT
CODES
DS DP U-1004
U-1015

U-1004

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N 020667 001 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784

U-784

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N 020667 002 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784

U-784

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N 020667 003 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784

U-784

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N 020667 005 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784

U-784

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N 020667 006 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784

U-784

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N 020667 007 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784

U-784

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N 022421 001 7695734
Apr 26, 2028
8679533
Sep 08, 2029

DP

DP U-219

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N 022421 002 7695734
Apr 26, 2028
8679533
Sep 08, 2029

DP

DP U-219

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N 022421 003 7695734
Apr 26, 2028
8679533
Sep 08, 2029

DP

DP U-219

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N 022421 004 7695734
Apr 26, 2028
8679533
Sep 08, 2029

DP

DP U-219

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N 022421 005 7695734
Apr 26, 2028
8679533
Sep 08, 2029

DP

DP U-219

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N 022421 006 7695734
Apr 26, 2028
8679533
Sep 08, 2029

DP

DP U-219

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N 022421 007 7695734
Apr 26, 2028
8679533
Sep 08, 2029

DP

DP U-219

PRAMLINTIDE ACETATE - SYMLIN

N 021332 001 5686411
5814600
6114304

Mar 16, 2019

Sep 29, 2015
Sep 05, 2017

DS DP U-638

U-639

U-640

PRAMLINTIDE ACETATE - SYMLIN

N 021332 002 5686411
5814600
5814600
5814600
6114304
6114304

Mar
Sep
Sep
Sep
Sep
Sep

DS DP U-638

U-637

U-638

U-639

U-637

U-640

16,
29,
29,
29,
05,
05,

2019
2015
2015
2015
2017
2017

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)
ODE

EXCLUSIVITY

EXPIRATION

DATE

Sep 24, 2016

ADA 179 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PRAMLINTIDE ACETATE - SYMLIN

N 021332 003 5686411
5814600
5814600
5814600
6114304
6114304

PATENT
EXPIRATION
DATE
Mar
Sep
Sep
Sep
Sep
Sep

16,
29,
29,
29,
05,
05,

2019
2015
2015
2015
2017
2017

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS DP U-638
U-637
U-638
U-639
U-637
U-640

PRASUGREL HYDROCHLORIDE - EFFIENT

N 022307 001 5288726
Apr 14, 2017
8404703
Jan 02, 2023
8569325
Jan 02, 2023

DS DP U-991
U-1381
U-1381

PRASUGREL HYDROCHLORIDE - EFFIENT

N 022307 002 5288726
Apr 14, 2017
8404703
Jan 02, 2023
8569325
Jan 02, 2023

DS DP U-991
U-1381
U-1381

PREDNISOLONE ACETATE - FLO-PRED

N 022067 001 5881926
6071523
6399079
6656482
7799331
7799331

Mar
Jun
Jun
Jun
Oct
Oct

16,
03,
03,
03,
11,
11,

2016
2018
2018
2018
2028
2028

DP
DP
DP
DP
DP U-139
DP U-1068

PREDNISOLONE ACETATE - FLO-PRED

N 022067 002 5881926
6071523
6399079
6656482
7799331
7799331

Mar
Jun
Jun
Jun
Oct
Oct

16,
03,
03,
03,
11,
11,

2016
2018
2018
2018
2028
2028

DP
DP
DP
DP
DP U-139
DP U-1068

PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT

N 021959 001 6024981
Apr 09, 2018
6221392
Apr 09, 2018
6740341
Nov 24, 2019

DP
DP
DP

Y
Y

PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT

N 021959 002 6024981
Apr 09, 2018
6221392
Apr 09, 2018
6740341
Nov 24, 2019

DP
DP
DP

Y
Y

PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT

N 021959 003 6024981
Apr 09, 2018
6221392
Apr 09, 2018
6740341
Nov 24, 2019

DP
DP
DP

Y
Y

PREDNISONE - RAYOS
N 202020 001 6488960
6677326
8309124
8394407
9040085
9186332

Mar
Mar
Apr
Apr
Apr
Apr

14,
14,
23,
23,
23,
23,

2020
2020
2024
2024
2024
2024

DP U-1267
DP U-1268
U-1292
DP U-1362
U-1362
U-1362

M-128

Jul 26, 2015

PREDNISONE - RAYOS
N 202020 002 6488960
6677326
8309124
8394407
9040085
9186332

Mar
Mar
Apr
Apr
Apr
Apr

14,
14,
23,
23,
23,
23,

2020
2020
2024
2024
2024
2024

DP U-1267
DP U-1268

M-128

Jul 26, 2015

PREDNISONE - RAYOS

N 202020 003 8168218
8309124
8394407
9040085

Jan
Apr
Apr
Apr

07,
23,
23,
23,

2028
2024
2024
2024

DP U-1269
U-1292

DP U-1362

U-1362

M-128

Jul 26, 2015

DP U-1362
U-1362
U-1362

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 180 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PREDNISONE - RAYOS
N 202020 003 9186332

Apr 23, 2024

U-1362

PREGABALIN - LYRICA
N 021446 001 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

U-55
U-819

PREGABALIN - LYRICA
N 021446 002 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

PREGABALIN - LYRICA
N 021446 003 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

PREGABALIN - LYRICA
N 021446 004 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

PREGABALIN - LYRICA
N 021446 005 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

PREGABALIN - LYRICA
N 021446 006 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

PREGABALIN - LYRICA
N 021446 007 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

PREGABALIN - LYRICA
N 021446 008 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

PREGABALIN - LYRICA
N 022488 001 6001876
6001876
6197819
RE41920

Dec
Dec
Dec
Dec

30,
30,
30,
30,

2018
2018
2018
2018

PROGESTERONE - ENDOMETRIN
N 022057 001 7300664
7320800
7393543

Nov 17, 2019

Nov 17, 2019
Nov 17, 2019

PROPOFOL - DIPRIVAN
N 019627 002 8476010
8476010*PED

Dec 01, 2024

Jun 01, 2025

PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL

N 021438 001 6500454
Oct 04, 2021

PATENT
DELIST
REQUESTED

Y
Y

DS DP
U-1250

U-55
U-819

Y
Y

DS DP
U-1250

U-55
U-819

Y
Y

DS DP
U-1250

U-55
U-819

Y
Y

DS DP
U-1250

U-55
U-819

Y
Y

DS DP
U-1250

U-55
U-819

Y
Y

DS DP
U-1250

U-55
U-819

Y
Y

DS DP
U-1250

U-55
U-819

Y
Y

DS DP
U-1250

U-55
U-819
DS DP
U-1250

U-856
U-856
DP U-880

DS DP

DP

Y
Y

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 181 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL
N 021438 002 6500454
Oct 04, 2021
APPL/PROD
NO

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP

PROPRANOLOL HYDROCHLORIDE - HEMANGEOL

N 205410 001 8338489
Oct 16, 2028

U-1496

QUAZEPAM - DORAL
N 018708 001 7608616

Jun 03, 2028

U-1012

QUAZEPAM - DORAL
N 018708 003 7608616

Jun 03, 2028

U-1012

QUETIAPINE FUMARATE - SEROQUEL XR

N 022047 001 5948437
May 28, 2017
5948437
May 28, 2017
5948437
May 28, 2017

DP U-601
DP U-814
DP U-839

QUETIAPINE FUMARATE - SEROQUEL XR

N 022047 002 5948437
May 28, 2017
5948437
May 28, 2017
5948437
May 28, 2017

DP U-601
DP U-814
DP U-839

QUETIAPINE FUMARATE - SEROQUEL XR

N 022047 003 5948437
May 28, 2017
5948437
May 28, 2017
5948437
May 28, 2017

DP U-601
DP U-814
DP U-839

QUETIAPINE FUMARATE - SEROQUEL XR

N 022047 004 5948437
May 28, 2017
5948437
May 28, 2017
5948437
May 28, 2017

DP U-601
DP U-814
DP U-839

QUETIAPINE FUMARATE - SEROQUEL XR

N 022047 005 5948437
May 28, 2017
5948437
May 28, 2017
5948437
May 28, 2017

DP U-601
DP U-814
DP U-839

RABEPRAZOLE SODIUM - ACIPHEX SPRINKLE

N 204736 001

RABEPRAZOLE SODIUM - ACIPHEX SPRINKLE

N 204736 002

RADIUM RA-223 DICHLORIDE - XOFIGO

N 203971 001 6635234
Jan 03, 2020

U-1405

RALOXIFENE HYDROCHLORIDE - EVISTA

N 020815 001 6458811
Mar
6797719
Mar
6894064
Mar
8030330
Mar

10,
10,
10,
10,

2017
2017
2017
2017

DS DP U-825
DP
DP U-657
DP

RALTEGRAVIR POTASSIUM - ISENTRESS

N 022145 001 7169780
Oct
7217713
Oct
7435734
Oct
7435734
Oct
7754731
Mar

03,
21,
21,
21,
11,

2023
2022
2022
2022
2029

DS DP

RALTEGRAVIR POTASSIUM - ISENTRESS

N 203045 001 7169780
Oct
7217713
Oct
7435734
Oct
7754731
Mar

03,
21,
21,
11,

2023
2022
2022
2029

DS DP

U-257
U-257
U-900
DS DP U-257

U-257
U-257
DS DP U-257

NP
ODE

Mar 14, 2017

Mar 14, 2021

NDF
PED

Mar 26, 2016

Sep 26, 2016

NDF
PED

Mar 26, 2016

Sep 26, 2016

NCE

May 15, 2018

ADA 182 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

RALTEGRAVIR POTASSIUM - ISENTRESS

N 203045 002 7169780
Oct
7217713
Oct
7435734
Oct
7754731
Mar

03,
21,
21,
11,

2023
2022
2022
2029

DS DP

RALTEGRAVIR POTASSIUM - ISENTRESS

N 205786 001 7169780
Oct
7217713
Oct
7435734
Oct
7754731
Mar

03,
21,
21,
11,

2023
2022
2022
2029

DS DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-257
U-257
DS DP U-257

NDF

Dec 20, 2016

I-685

May 29, 2017

U-257
U-257
DS DP U-257

RAMELTEON - ROZEREM
N 021782 001 6034239

Jul 22, 2019

DS DP U-674

RAMIPRIL - ALTACE
N 019901 001 7368469

Aug 30, 2020

U-871

RAMIPRIL - ALTACE
N 019901 002 7368469

Aug 30, 2020

U-871

RAMIPRIL - ALTACE
N 019901 003 7368469

Aug 30, 2020

U-871

RAMIPRIL - ALTACE
N 019901 004 7368469

Aug 30, 2020

U-871

RAMIPRIL - ALTACE
N 022021 001 7368469

Aug 30, 2020

U-871

RAMIPRIL - ALTACE
N 022021 002 7368469

Aug 30, 2020

U-871

RAMIPRIL - ALTACE
N 022021 003 7368469

Aug 30, 2020

U-871

RAMIPRIL - ALTACE
N 022021 004 7368469

Aug 30, 2020

U-871

RANOLAZINE - RANEXA
N 021526 001 6303607
6369062
6479496
6503911
6525057
6562826
6617328
6620814
6852724
6864258

May
May
May
May
May
May
May
May
May
May

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2019
2019
2019
2019
2019
2019
2019
2019
2019
2019

RANOLAZINE - RANEXA
N 021526 002 6303607
6369062
6479496
6503911
6525057
6562826
6617328
6620814
6852724
6864258

May
May
May
May
May
May
May
May
May
May

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2019
2019
2019
2019
2019
2019
2019
2019
2019
2019

RASAGILINE MESYLATE - AZILECT

N 021641 001 5453446
6126968
7572834
7815942

Feb
Sep
Dec
Aug

07,
18,
05,
27,

2017
2016
2026
2027

U-705
DP

Y
U-705

DP
U-705
U-705
DP
U-705
U-705
U-705

U-705
DP
U-705
DP
U-705
U-705
DP
U-705
U-705
U-705

U-219
DP
DP
DS DP U-219

ADA 183 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

RASAGILINE MESYLATE - AZILECT

N 021641 002 5453446
6126968
7572834
7815942

Feb
Sep
Dec
Aug

07,
18,
05,
27,

2017
2016
2026
2027

U-219
DP
DP
DS DP U-219

REGADENOSON - LEXISCAN
N 022161 001 6403567
6642210
7144872
7144872
7144872
7183264
7183264
7183264
7582617
7655636
7655637
7683037
8106029
8106183
8133879
8183226
8470801
8536150
9045519
9085601

Apr
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Feb
Jun
Jun
Jun
Jun
Jun
Feb

10,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
02,
22,
22,
22,
22,
22,
02,

2022
2019
2019
2019
2019
2019
2019
2019
2019
2019
2019
2019
2019
2027
2019
2019
2019
2019
2019
2027

DS
DS
DS
DS
DS

REGORAFENIB - STIVARGA
N 203085 001 7351834
8637553
8680124

Jan 12, 2020

Feb 16, 2031
Jun 02, 2030

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-685

May 29, 2017

I-667
NCE
ODE

Feb 25, 2016

Sep 27, 2017
Feb 25, 2020

DP
DP
DP
DP
DP
DP
DP
DP

U-869
U-869
U-116
U-869
U-870
U-116
U-869
U-870
U-1003
U-869
DS DP U-869
U-1042
U-1042
DS
DP
U-116
U-116
U-116
DP
DP

DS
DS DP
U-1506

REMIFENTANIL HYDROCHLORIDE - ULTIVA

N 020630 001 5866591
Sep 10, 2017

DP

REMIFENTANIL HYDROCHLORIDE - ULTIVA

N 020630 002 5866591
Sep 10, 2017

DP

REMIFENTANIL HYDROCHLORIDE - ULTIVA

N 020630 003 5866591
Sep 10, 2017

DP

RETAPAMULIN - ALTABAX
N 022055 001 7875630
RE39128
RE43390

Feb 14, 2027

Apr 12, 2021
Apr 12, 2021

DS
DS DP U-805
DS DP U-805

RIBAVIRIN - VIRAZOLE
N 018859 001 6150337

Nov 21, 2017

U-400

RIBAVIRIN - REBETOL
N 020903 001 6172046
6172046
6177074
6177074
6461605
6461605
6472373
6472373
6524570
6524570

Sep
Sep
Nov
Nov
Nov
Nov
Sep
Sep
Nov
Nov

21,
21,
01,
01,
01,
01,
21,
21,
01,
01,

2017
2017
2016
2016
2016
2016
2017
2017
2016
2016

U-377
U-1014
U-454
U-1013
U-478
U-1013
U-479
U-1014
U-499
U-1013

RIBAVIRIN - REBETOL
N 020903 002 6172046
6172046
6177074
6177074
6461605
6461605
6472373

Sep
Sep
Nov
Nov
Nov
Nov
Sep

21,
21,
01,
01,
01,
01,
21,

2017
2017
2016
2016
2016
2016
2017

U-377
U-1014
U-454
U-1013
U-478
U-1013
U-479

ADA 184 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

RIBAVIRIN - REBETOL
N 020903 002 6472373
6524570
6524570

Sep 21, 2017

Nov 01, 2016
Nov 01, 2016

U-1014
U-499
U-1013

RIBAVIRIN - REBETOL
N 021546 001 6172046
6172046
6177074
6461605
6461605
6472373
6524570
6790837

Sep
Sep
Nov
Nov
Nov
Sep
Nov
Apr

21,
21,
01,
01,
01,
21,
01,
05,

2017
2017
2016
2016
2016
2017
2016
2023

U-521
U-1014
U-1013
U-521
U-1013
U-521
U-1013

RIFAXIMIN - XIFAXAN
N 021361 001 7045620
7612199
7902206
7906542
7928115
8158644
8158781
8193196
8518949
8741904
8835452
8853231

Jun
Jun
Jun
Jun
Jul
Jun
Jun
Sep
Feb
Feb
Jun
Jun

19,
19,
19,
01,
24,
19,
19,
02,
27,
27,
19,
19,

2024
2024
2024
2025
2029
2024
2024
2027
2026
2026
2024
2024

RIFAXIMIN - XIFAXAN
N 022554 001 6861053
6861053
7045620
7452857
7452857
7605240
7605240
7612199
7718608
7718608
7902206
7906542
7915275
7915275
7935799
7935799
8158644
8158781
8193196
8193196
8309569
8309569
8518949
8642573
8741904
8741904
8741904
8829017
8835452
8853231
8946252
8969398

Aug
Aug
Jun
Aug
Aug
Aug
Aug
Jun
Aug
Aug
Jun
Jun
Feb
Feb
Aug
Aug
Jun
Jun
Sep
Sep
Jul
Jul
Feb
Oct
Feb
Feb
Feb
Jul
Jun
Jun
Jul
Oct

11,
11,
19,
11,
11,
11,
11,
19,
11,
11,
19,
01,
23,
23,
11,
11,
19,
19,
02,
02,
18,
18,
27,
02,
27,
27,
27,
24,
19,
19,
24,
02,

2019
2019
2024
2019
2019
2019
2019
2024
2019
2019
2024
2025
2025
2025
2019
2019
2024
2024
2027
2027
2029
2029
2026
2029
2026
2026
2026
2029
2024
2024
2029
2029

RILPIVIRINE HYDROCHLORIDE - EDURANT

N 202022 001 6838464
Feb
7067522
Dec
7125879
Aug
7125879
Aug
7125879
Aug
7638522
Apr

26,
20,
09,
09,
09,
14,

2021
2019
2022
2022
2022
2023

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP

DS
DS
DS
DS

DP
DP
DP
DP
U-1121
DP

DS
DS DP
DP
DS
U-1526
DS DP
DP

U-1707
U-1708

I-709
ODE

May 27, 2018

Mar 24, 2017

NCE
NPP

May 20, 2016

Aug 26, 2018

DS
U-1707
U-1708
U-1707
U-1708
DS DP
U-1707
U-1708
DS DP
DS DP
U-1707
U-1708
U-1707
U-1708
DP
DS
DS DP U-1707
DS DP U-1708
U-1707
U-1708
DP
U-1481
DS
U-1526
DS
U-1707
DS
U-1708
U-1562
DS DP
DP
U-1481
U-1481

DS
DS
DS
DS
DS

DP
DP
DP U-1153
DP U-1307
DP U-1740
DP

ADA 185 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
RILPIVIRINE HYDROCHLORIDE - EDURANT
N 202022 001 8080551
Apr 11, 2023
8101629
Aug 09, 2022

DS DP
DP

RIOCIGUAT - ADEMPAS
N 204819 001 6743798
7173037

Jul 16, 2019

Apr 25, 2023

DS DP
DS DP

NCE
ODE

Oct 08, 2018

Oct 08, 2020

RIOCIGUAT - ADEMPAS
N 204819 002 6743798
7173037

Jul 16, 2019

Apr 25, 2023

DS DP
DS DP

NCE
ODE

Oct 08, 2018

Oct 08, 2020

RIOCIGUAT - ADEMPAS
N 204819 003 6743798
7173037

Jul 16, 2019

Apr 25, 2023

DS DP
DS DP

NCE
ODE

Oct 08, 2018

Oct 08, 2020

RIOCIGUAT - ADEMPAS
N 204819 004 6743798
7173037

Jul 16, 2019

Apr 25, 2023

DS DP
DS DP

NCE
ODE

Oct 08, 2018

Oct 08, 2020

RIOCIGUAT - ADEMPAS
N 204819 005 6743798
7173037

Jul 16, 2019

Apr 25, 2023

DS DP
DS DP

NCE
ODE

Oct 08, 2018

Oct 08, 2020

RISEDRONATE SODIUM - RISEDRONATE SODIUM

A 077132 001

PC

Nov 28, 2015

RISEDRONATE SODIUM - RISEDRONATE SODIUM

A 077132 002

PC

Nov 28, 2015

RISEDRONATE SODIUM - RISEDRONATE SODIUM

A 077132 003

PC

Nov 28, 2015

APPL/PROD
NO

PATENT NO

PATENT
CODES

RISEDRONATE SODIUM - ACTONEL

N 020835 001 6165513

Jun 10, 2018

RISEDRONATE SODIUM - ACTONEL

N 020835 002 6165513

Jun 10, 2018

RISEDRONATE SODIUM - ACTONEL

N 020835 003 5994329
6015801
6165513
6432932
6465443

Jul
Jul
Jun
Jul
Aug

2018
2018
2018
2018
2018

DP

RISEDRONATE SODIUM - ACTONEL

N 020835 004 6165513

Jun 10, 2018

DP

RISEDRONATE SODIUM - ACTONEL

N 020835 005 6165513
7192938
7718634

Jun 10, 2018

May 06, 2023
May 06, 2023

DP

RISEDRONATE SODIUM - ATELVIA

N 022560 001 7645459
7645460
8246989

Jan 09, 2028

Jan 09, 2028
Jan 16, 2026

DP U-662
DP U-662
DP

RISPERIDONE - RISPERDAL CONSTA

N 021346 001 5792477
5916598
6194006
6379703
6403114
6596316
6667061

May
May
Dec
Dec
May
Dec
May

DP
DP
DP
DP
DP
DP
DP

17,
17,
10,
17,
14,

02,
02,
30,
30,
02,
30,
25,

2017
2017
2018
2018
2017
2018
2020

U-353
U-353
U-595
DP

U-353
U-662

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 186 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

RISPERIDONE - RISPERDAL CONSTA

N 021346 002 5792477
5916598
6194006
6379703
6403114
6596316
6667061

May
May
Dec
Dec
May
Dec
May

02,
02,
30,
30,
02,
30,
25,

2017
2017
2018
2018
2017
2018
2020

DP
DP
DP
DP
DP
DP
DP

RISPERIDONE - RISPERDAL CONSTA

N 021346 003 5792477
5916598
6194006
6379703
6403114
6596316
6667061

May
May
Dec
Dec
May
Dec
May

02,
02,
30,
30,
02,
30,
25,

2017
2017
2018
2018
2017
2018
2020

DP
DP
DP
DP
DP
DP
DP

RISPERIDONE - RISPERDAL CONSTA

N 021346 004 5792477
5916598
6194006
6379703
6403114
6596316

May
May
Dec
Dec
May
Dec

02,
02,
30,
30,
02,
30,

2017
2017
2018
2018
2017
2018

DP
DP
DP
DP
DP
DP

RISPERIDONE - RISPERDAL
N 021444 001 6224905

Jun 10, 2017

DP

RISPERIDONE - RISPERDAL
N 021444 002 6224905

Jun 10, 2017

DP

RISPERIDONE - RISPERDAL
N 021444 003 6224905

Jun 10, 2017

DP

RISPERIDONE - RISPERDAL
N 021444 004 6224905

Jun 10, 2017

DP

RISPERIDONE - RISPERDAL
N 021444 005 6224905

Jun 10, 2017

DP

RITONAVIR - NORVIR
N 020659 001 6037157
6703403

Jun 26, 2016

Jun 26, 2016

RITONAVIR - NORVIR
N 020945 001 6037157
6232333
6703403
7141593
7432294

Jun
Nov
Jun
May
May

26,
07,
26,
22,
22,

2016
2017
2016
2020
2020

RITONAVIR - NORVIR
N 022417 001 6037157
6703403
7148359
7364752
8268349
8399015
8399015*PED
8470347
8470347*PED
8691878
8691878*PED

Jun
Jun
Jul
Nov
Aug
Aug
Feb
Sep
Mar
Aug
Feb

26,
26,
19,
10,
25,
25,
25,
17,
17,
25,
25,

2016
2016
2019
2020
2024
2024
2025
2026
2027
2024
2025

RIVAROXABAN - XARELTO
N 022406 001 7157456
7157456
7585860
7592339

Feb
Feb
Dec
Dec

08,
08,
11,
11,

2021
2021
2020
2020

PATENT NO

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-564

U-895
U-564
DP
DP

U-688
U-688
DP
DP U-688
DP
DP
DP
U-688

DS DP U-1301
DS DP U-1302
DS
U-1303
U-1167

I-660
I-661
I-662
NCE

Nov
Nov
Nov
Jul

02,
02,
02,
01,

2015
2015
2015
2016

ADA 187 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

RIVAROXABAN - XARELTO
N 022406 001 7592339
7592339
7592339
7592339

Dec
Dec
Dec
Dec

11,
11,
11,
11,

2020
2020
2020
2020

U-1200
U-1301
U-1302
U-1303

RIVAROXABAN - XARELTO
N 022406 002 7157456
7157456
7585860
7592339
7592339
7592339
7592339
7592339

Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec

08,
08,
11,
11,
11,
11,
11,
11,

2021
2021
2020
2020
2020
2020
2020
2020

DS DP U-1301
DS DP U-1302
DS
U-1303
U-1167
U-1200
U-1301
U-1302
U-1303

I-660
I-661
I-662
NCE

Nov
Nov
Nov
Jul

02,
02,
02,
01,

2015
2015
2015
2016

RIVAROXABAN - XARELTO
N 022406 003 7157456
7157456
7585860
7592339
7592339
7592339
7592339
7592339

Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec

08,
08,
11,
11,
11,
11,
11,
11,

2021
2021
2020
2020
2020
2020
2020
2020

DS DP U-1301
DS DP U-1302
DS
U-1303
U-1167
U-1200
U-1301
U-1302
U-1303

I-660
I-661
I-662
NCE

Nov
Nov
Nov
Jul

02,
02,
02,
01,

2015
2015
2015
2016

PC

Feb 29, 2016

NPP
NS

Jun 27, 2016

Aug 31, 2015

RIVASTIGMINE - RIVASTIGMINE
A 204403 003
RIVASTIGMINE - EXELON
N 022083 001 6316023
6335031

Jan 08, 2019

Jan 08, 2019

DP
DP

RIVASTIGMINE - EXELON
N 022083 002 6316023
6335031

Jan 08, 2019

Jan 08, 2019

DP
DP

RIVASTIGMINE - EXELON
N 022083 005 6316023
6335031

Jan 08, 2019

Jan 08, 2019

DP
DP

ROFECOXIB - VIOXX
N 021042 001 6063811

May 06, 2017

U-602

ROFECOXIB - VIOXX
N 021042 002 6063811

May 06, 2017

U-602

ROFECOXIB - VIOXX
N 021042 003 6063811

May 06, 2017

U-602

ROFECOXIB - VIOXX
N 021052 001 6063811

May 06, 2017

U-266

ROFECOXIB - VIOXX
N 021052 002 6063811

May 06, 2017

U-266

ROFLUMILAST - DALIRESP
N 022522 001 5712298
8431154
8536206
8604064
8618142

Jan
Feb
Mar
Mar
Mar

27,
19,
08,
08,
08,

2020
2023
2024
2024
2024

DS DP U-1115
DP
U-1115
U-1115
DP

NCE

Feb 28, 2016

ROLAPITANT HYDROCHLORIDE - VARUBI

N 206500 001 7049320
Dec
7563801
Apr
7981905
Apr
8178550
Apr
8361500
Oct
8404702
Oct
8470842
Jan

08,
04,
04,
04,
09,
09,
18,

2023
2027
2027
2027
2029
2029
2029

DS DP U-1741
DP
U-1741
DS DP
DP
U-1741
U-1741

NCE

Sep 01, 2020

ADA 188 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ROLAPITANT HYDROCHLORIDE - VARUBI

N 206500 001 8796299
Dec 17, 2022
ROMIDEPSIN - ISTODAX
N 022393 001 7608280
7611724

Aug 22, 2021

Aug 22, 2021

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1741

DS
DS

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N 022008 001 7927624
Dec 02, 2021
8303986
Apr 12, 2021

DP U-20
DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N 022008 002 7927624
Dec 02, 2021
8303986
Apr 12, 2021

DP U-20
DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N 022008 003 7927624
Dec 02, 2021
8303986
Apr 12, 2021

DP U-20
DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N 022008 004 7927624
Dec 02, 2021
8303986
Apr 12, 2021

DP U-20
DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N 022008 005 7927624
Dec 02, 2021
8303986
Apr 12, 2021

DP U-20
DP

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N 022008 006 7927624
Dec 02, 2021
8303986
Apr 12, 2021

DP U-20
DP

ROPIVACAINE HYDROCHLORIDE - NAROPIN

N 020533 001 7828787
Oct
7857802
Nov
8118802
May
8162915
May

DP
DP
DP
DP

18,
28,
18,
23,

PATENT
DELIST
REQUESTED

2025
2026
2023
2024

ROSIGLITAZONE MALEATE - AVANDIA

N 021071 002 6288095
7358366

Feb 11, 2017

Apr 19, 2020

DS

ROSIGLITAZONE MALEATE - AVANDIA

N 021071 003 6288095
7358366

Feb 11, 2017

Apr 19, 2020

DS

ROSIGLITAZONE MALEATE - AVANDIA

N 021071 004 6288095
7358366

Feb 11, 2017

Apr 19, 2020

DS

ROSUVASTATIN CALCIUM - CRESTOR

N 021366 002 6316460
6858618
6858618
6858618*PED
7030152
7964614
RE37314

Aug
Dec
Dec
Jun
Apr
Apr
Jan

04,
17,
17,
17,
02,
02,
08,

2020
2021
2021
2022
2018
2018
2016

ROSUVASTATIN CALCIUM - CRESTOR

N 021366 003 6316460
6858618
6858618
6858618*PED
7030152
7964614
RE37314

Aug
Dec
Dec
Jun
Apr
Apr
Jan

04,
17,
17,
17,
02,
02,
08,

2020
2021
2021
2022
2018
2018
2016

ROSUVASTATIN CALCIUM - CRESTOR

N 021366 004 6316460
6858618
6858618

Aug 04, 2020

Dec 17, 2021
Dec 17, 2021

U-420

U-420

U-420

DP

ODE
ODE

Nov 05, 2016

Jun 16, 2018

NPP

Nov 20, 2018

NPP

Nov 20, 2018

NPP

Nov 20, 2018

U-618
U-1032
U-1032
U-1032
DS

DP
U-618
U-1032
U-1032
U-1032
DS

DP
U-618
U-1032

ADA 189 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ROSUVASTATIN CALCIUM - CRESTOR

N 021366 004 6858618*PED
7030152
7964614
RE37314

Jun
Apr
Apr
Jan

17,
02,
02,
08,

2022
2018
2018
2016

ROSUVASTATIN CALCIUM - CRESTOR

N 021366 005 6316460
6858618
7030152
7964614
RE37314

Aug
Dec
Apr
Apr
Jan

04,
17,
02,
02,
08,

2020
2021
2018
2018
2016

ROTIGOTINE - NEUPRO
N 021829 001 6699498
6884434
7413747
8246979
8246979
8246980
8617591

Nov
Mar
Mar
Sep
Sep
Nov
Jul

27,
30,
18,
01,
01,
27,
22,

2020
2021
2019
2027
2027
2025
2023

DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474

ROTIGOTINE - NEUPRO
N 021829 002 6699498
6884434
7413747
8246979
8246979
8246980
8617591

Nov
Mar
Mar
Sep
Sep
Nov
Jul

27,
30,
18,
01,
01,
27,
22,

2020
2021
2019
2027
2027
2025
2023

DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474

ROTIGOTINE - NEUPRO
N 021829 003 6699498
6884434
7413747
8246979
8246979
8246980
8617591

Nov
Mar
Mar
Sep
Sep
Nov
Jul

27,
30,
18,
01,
01,
27,
22,

2020
2021
2019
2027
2027
2025
2023

DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474

ROTIGOTINE - NEUPRO
N 021829 004 6699498
6884434
7413747
8246979
8246979
8246980
8617591

Nov
Mar
Mar
Sep
Sep
Nov
Jul

27,
30,
18,
01,
01,
27,
22,

2020
2021
2019
2027
2027
2025
2023

DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474

ROTIGOTINE - NEUPRO
N 021829 005 6699498
6884434
7413747
8246979
8246979
8246980
8617591

Nov
Mar
Mar
Sep
Sep
Nov
Jul

27,
30,
18,
01,
01,
27,
22,

2020
2021
2019
2027
2027
2025
2023

DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474

ROTIGOTINE - NEUPRO
N 021829 006 6699498
6884434
7413747
8246979
8246979
8246980
8617591

Nov
Mar
Mar
Sep
Sep
Nov
Jul

27,
30,
18,
01,
01,
27,
22,

2020
2021
2019
2027
2027
2025
2023

DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474

RUFINAMIDE - BANZEL
N 021911 001 6740669
6740669*PED

Nov 14, 2022

May 14, 2023

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1032
U-1032
DS

DP
U-618
U-1032
U-1032
DS

DS DP

ODE
PED

Nov 14, 2015

May 14, 2016

ADA 190 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

RUFINAMIDE - BANZEL
N 021911 001 7750028
7750028*PED
8076362
8076362*PED

Oct
Apr
Jun
Dec

19,
19,
08,
08,

2018
2019
2018
2018

RUFINAMIDE - BANZEL
N 021911 002 6740669
6740669*PED
7750028
7750028*PED
8076362
8076362*PED

Nov
May
Oct
Apr
Jun
Dec

14,
14,
19,
19,
08,
08,

2022
2023
2018
2019
2018
2018

DS DP

RUFINAMIDE - BANZEL
N 021911 003 6740669
6740669*PED
7750028
7750028*PED
8076362
8076362*PED

Nov
May
Oct
Apr
Jun
Dec

14,
14,
19,
19,
08,
08,

2022
2023
2018
2019
2018
2018

DS DP

RUFINAMIDE - BANZEL
N 201367 001 6740669
6740669*PED
7750028
7750028*PED

Nov
May
Oct
Apr

14,
14,
19,
19,

2022
2023
2018
2019

DS DP

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 001 7598257
7598257
8415362
8722693
8822481
8829013
8829013
9079912
9079912

Dec
Dec
Dec
Jun
Jun
Jun
Jun
Dec
Dec

24,
24,
24,
12,
12,
12,
12,
12,
12,

2027
2027
2027
2028
2028
2028
2028
2026
2026

DS
DS
DS
DS

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 002 7598257
7598257
8415362
8722693
8822481
8829013
8829013
9079912
9079912

Dec
Dec
Dec
Jun
Jun
Jun
Jun
Dec
Dec

24,
24,
24,
12,
12,
12,
12,
12,
12,

2027
2027
2027
2028
2028
2028
2028
2026
2026

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 003 7598257
7598257
8415362
8722693
8822481
8829013
8829013
9079912
9079912

Dec
Dec
Dec
Jun
Jun
Jun
Jun
Dec
Dec

24,
24,
24,
12,
12,
12,
12,
12,
12,

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 004 7598257
7598257
8415362
8722693
8822481
8829013
8829013
9079912

Dec
Dec
Dec
Jun
Jun
Jun
Jun
Dec

24,
24,
24,
12,
12,
12,
12,
12,

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-106
DP

ODE
PED

Nov 14, 2015

May 14, 2016

ODE
PED

Nov 14, 2015

May 14, 2016

ODE
PED

Nov 14, 2015

May 14, 2016

DP U-1201
DP U-1622
DP
DP
U-1573
U-1201
U-1622
U-1573
U-1721

I-699
NCE
ODE
ODE

Dec
Nov
Nov
Dec

04,
16,
16,
04,

2017
2016
2018
2021

DS
DS
DS
DS

DP U-1201
DP U-1622
DP
DP
U-1573
U-1201
U-1622
U-1573
U-1721

I-699
NCE
ODE
ODE

Dec
Nov
Nov
Dec

04,
16,
16,
04,

2017
2016
2018
2021

2027
2027
2027
2028
2028
2028
2028
2026
2026

DS
DS
DS
DS

DP U-1201
DP U-1622
DP
DP
U-1573
U-1201
U-1622
U-1573
U-1721

I-699
NCE
ODE
ODE

Dec
Nov
Nov
Dec

04,
16,
16,
04,

2017
2016
2018
2021

2027
2027
2027
2028
2028
2028
2028
2026

DS
DS
DS
DS

DP U-1201
DP U-1622
DP
DP
U-1573
U-1201
U-1622
U-1573

I-699
NCE
ODE
ODE

Dec
Nov
Nov
Dec

04,
16,
16,
04,

2017
2016
2018
2021

U-106
DP

U-106
DP

U-106

ADA 191 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 004 9079912

Dec 12, 2026

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 005 7598257
7598257
8415362
8722693
8822481
8829013
8829013
9079912
9079912

Dec
Dec
Dec
Jun
Jun
Jun
Jun
Dec
Dec

24,
24,
24,
12,
12,
12,
12,
12,
12,

2027
2027
2027
2028
2028
2028
2028
2026
2026

SACUBITRIL; VALSARTAN - ENTRESTO

N 207620 001 7468390
Nov 27, 2023
8101659
Jan 14, 2023
8404744
Jan 14, 2023
8796331
Jan 14, 2023
8877938
May 27, 2027
SACUBITRIL; VALSARTAN - ENTRESTO
N 207620 002 7468390
Nov 27, 2023
8101659
Jan 14, 2023
8404744
Jan 14, 2023
8796331
Jan 14, 2023
8877938
May 27, 2027
SACUBITRIL; VALSARTAN - ENTRESTO
N 207620 003 7468390
Nov 27, 2023
8101659
Jan 14, 2023
8404744
Jan 14, 2023
8796331
Jan 14, 2023
8877938
May 27, 2027
SALMETEROL XINAFOATE - SEREVENT
N 020692 001 5873360

Feb 23, 2016

SAPROPTERIN DIHYDROCHLORIDE - KUVAN

N 022181 001 7566462
Nov
7566462*PED
May
7566714
Nov
7566714*PED
May
7612073
Nov
7612073*PED
May
7727987
Nov
7727987*PED
May
7947681
Nov
7947681*PED
May
8003126
Nov
8003126*PED
May
8067416
Nov
8067416*PED
May
8318745
Nov
8318745*PED
May
RE43797
Nov
RE43797*PED
May

16,
16,
17,
17,
17,
17,
17,
17,
17,
17,
16,
16,
17,
17,
17,
17,
17,
17,

2025
2026
2024
2025
2024
2025
2024
2025
2024
2025
2025
2026
2024
2025
2024
2025
2024
2025

SAPROPTERIN DIHYDROCHLORIDE - KUVAN

N 205065 001 7566714
Nov
7566714*PED
May
7612073
Nov
7612073*PED
May
8067416
Nov
8067416*PED
May
RE43797
Nov
RE43797*PED
May

17,
17,
17,
17,
17,
17,
17,
17,

2024
2025
2024
2025
2024
2025
2024
2025

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1721

DS
DS
DS
DS

DP U-1201
DP U-1622
DP
DP
U-1573
U-1201
U-1622
U-1573
U-1721

I-699
NCE
ODE
ODE

Dec
Nov
Nov
Dec

04,
16,
16,
04,

2017
2016
2018
2021

DP
DP
DP

NCE

Jul 07, 2020

NCE

Jul 07, 2020

NCE

Jul 07, 2020

NPP
PED

Apr 23, 2017

Oct 23, 2017

U-1723
DS DP

DP
DP
DP
U-1723
DS DP

DP
DP
DP
U-1723
DS DP

DP

DP
U-989
U-1010
DP
U-1156

U-989
DP
U-1156

U-1589
U-1010
U-1589
U-1590

ADA 192 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
SAPROPTERIN DIHYDROCHLORIDE - KUVAN
N 205065 002 7566714
Nov 17, 2024
7566714*PED
May 17, 2025
7612073
Nov 17, 2024
8067416
Nov 17, 2024
8067416*PED
May 17, 2025
RE43797
Nov 17, 2024
APPL/PROD
NO

PATENT NO

SAQUINAVIR - FORTOVASE
N 020828 001 6352717

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1589
U-1010
U-1589
U-1590

Nov 16, 2019

SAQUINAVIR MESYLATE - INVIRASE

N 020628 001

SAQUINAVIR MESYLATE - INVIRASE

N 021785 001

M-61
PED

Nov 30, 2015

May 30, 2016

M-61
PED

Nov 30, 2015

May 30, 2016

SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA

N 022350 001 7951400
Nov 30, 2028
RE44186
Jul 31, 2023

DP
DS DP U-995

M-134

May 24, 2016

SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA

N 022350 002 7951400
Nov 30, 2028
RE44186
Jul 31, 2023

DP
DS DP U-995

M-134

May 24, 2016

SELEGILINE - EMSAM
N 021336 001 7070808
7150881
7638140

May 10, 2018

Jun 12, 2018
May 10, 2018

DS DP
DS DP
DP

SELEGILINE - EMSAM
N 021336 002 7070808
7150881
7638140

May 10, 2018

Jun 12, 2018
May 10, 2018

DS DP
DS DP
DP

SELEGILINE - EMSAM
N 021336 003 7070808
7150881
7638140

May 10, 2018

Jun 12, 2018
May 10, 2018

DS DP
DS DP
DP

SELEGILINE HYDROCHLORIDE - ZELAPAR

N 021479 001 6423342
Mar 01, 2016

DP

SELEXIPAG - UPTRAVI
N 207947 001

NCE

Dec 21, 2020

SELEXIPAG - UPTRAVI
N 207947 002

NCE

Dec 21, 2020

SELEXIPAG - UPTRAVI
N 207947 003

NCE

Dec 21, 2020

SELEXIPAG - UPTRAVI
N 207947 004

NCE

Dec 21, 2020

SELEXIPAG - UPTRAVI
N 207947 005

NCE

Dec 21, 2020

SELEXIPAG - UPTRAVI
N 207947 006

NCE

Dec 21, 2020

SELEXIPAG - UPTRAVI
N 207947 007

NCE

Dec 21, 2020

SELEXIPAG - UPTRAVI
N 207947 008

NCE

Dec 21, 2020

ADA 193 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

SERTRALINE HYDROCHLORIDE - ZOLOFT

N 020990 001 6727283
Oct 11, 2019
7067555
Oct 11, 2019
7067555*PED
Apr 11, 2020
SEVELAMER CARBONATE - RENVELA
N 022127 001 7985418

DP

SEVELAMER HYDROCHLORIDE - RENAGEL

N 021179 001 6733780
Oct 18, 2020

DP

SEVELAMER HYDROCHLORIDE - RENAGEL

N 021179 002 6733780
Oct 18, 2020

DP

SEVOFLURANE - ULTANE
N 020478 001 5990176
6074668
6288127
6444859

Jan
Jan
Jan
Jan

SILDENAFIL CITRATE - VIAGRA

N 020895 001 6469012

Oct 22, 2019

U-155

SILDENAFIL CITRATE - VIAGRA

N 020895 002 6469012

Oct 22, 2019

U-155

SILDENAFIL CITRATE - VIAGRA

N 020895 003 6469012

Oct 22, 2019

U-155

SILDENAFIL CITRATE - REVATIO

N 022473 001

SILDENAFIL CITRATE - REVATIO

N 203109 001

SILODOSIN - RAPAFLO
N 022206 001 5387603

Dec 01, 2018

DS DP

SILODOSIN - RAPAFLO
N 022206 002 5387603

Dec 01, 2018

DS DP

SIMEPREVIR SODIUM - OLYSIO

N 205123 001 7671032
8148399
8349869
8741926
8754106
9040562

May
Sep
Jul
Jul
Jul
Jul

DS
DS
DS
DS
DS
DS

SIMVASTATIN; SITAGLIPTIN PHOSPHATE N 202343 001 6303661

Apr
6699871
Jul
6890898
Feb
6890898
Feb
6890898
Feb
7078381
Feb
7125873
Jul
7125873
Jul
7125873
Jul

EXCLUSIVITY
EXPIRATION
DATE

2017
2018
2017
2017

SILDENAFIL CITRATE - REVATIO

N 021845 001

19,
05,
28,
28,
28,
28,

EXCLUSIVITY
CODE(S)

DP U-580
DP

Oct 27, 2025

27,
09,
27,
27,

PATENT
DELIST
REQUESTED

2025
2029
2026
2026
2026
2026

JUVISYNC
24, 2017
26, 2022
02, 2019
02, 2019
02, 2019
02, 2019
26, 2022
26, 2022
26, 2022

DP
DP U-1467
DP U-1467
U-1467
U-1467
DP U-1467

U-1188
DS DP U-1188
U-1189
U-1190
U-1191
U-1188
DP U-1189
DP U-1190
DP U-1192

D-137
M-133
M-61
PED

Jan
Jan
Aug
Mar

31,
31,
30,
01,

2017
2017
2015
2016

D-137
M-133
M-61
PED

Jan
Jan
Aug
Mar

31,
31,
30,
01,

2017
2017
2015
2016

D-137
M-133
NDF
PED

Jan
Jan
Aug
Mar

31,
31,
30,
01,

2017
2017
2015
2016

D-151
I-697
I-717
NCE

Oct
Nov
Oct
Nov

05,
05,
05,
22,

2018
2017
2018
2018

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 194 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT

EXPIRATION

DATE

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

N 202343 001 7125873
Jul 26, 2022

7326708
Apr 11, 2026

7459428
Feb 02, 2019

8168637
Jun 26, 2022

DP U-1193

DS DP U-1188

U-1189

DP U-1188

SIMVASTATIN; SITAGLIPTIN PHOSPHATE N 202343 002 6303661

Apr
6699871
Jul
6890898
Feb
6890898
Feb
6890898
Feb
7078381
Feb
7125873
Jul
7125873
Jul
7125873
Jul
7125873
Jul
7326708
Apr
7459428
Feb
8168637
Jun

JUVISYNC

24, 2017

26, 2022

02, 2019

02, 2019

02, 2019

02, 2019

26, 2022

26, 2022

26, 2022

26, 2022

11, 2026

02, 2019

26, 2022

U-1188

DS DP U-1188

U-1189

U-1190

U-1191

U-1188

DP U-1189

DP U-1190

DP U-1192

DP U-1193

DS DP U-1188

U-1189

DP U-1188

SIMVASTATIN; SITAGLIPTIN PHOSPHATE N 202343 003 6303661

Apr
6699871
Jul
6890898
Feb
6890898
Feb
6890898
Feb
7078381
Feb
7125873
Jul
7125873
Jul
7125873
Jul
7125873
Jul
7326708
Apr
7459428
Feb
8168637
Jun

JUVISYNC

24, 2017

26, 2022

02, 2019

02, 2019

02, 2019

02, 2019

26, 2022

26, 2022

26, 2022

26, 2022

11, 2026

02, 2019

26, 2022

U-1188

DS DP U-1188

U-1189

U-1190

U-1191

U-1188

DP U-1189

DP U-1190

DP U-1192

DP U-1193

DS DP U-1188

U-1189

DP U-1188

SIMVASTATIN; SITAGLIPTIN PHOSPHATE N 202343 004 6303661

Apr
6699871
Jul
6890898
Feb
6890898
Feb
6890898
Feb
7078381
Feb
7125873
Jul
7125873
Jul
7125873
Jul
7125873
Jul
7326708
Apr
7459428
Feb
8168637
Jun

JUVISYNC

24, 2017

26, 2022

02, 2019

02, 2019

02, 2019

02, 2019

26, 2022

26, 2022

26, 2022

26, 2022

11, 2026

02, 2019

26, 2022

U-1188

DS DP U-1188

U-1189

U-1190

U-1191

U-1188

DP U-1189

DP U-1190

DP U-1192

DP U-1193

DS DP U-1188

U-1189

DP U-1188

SIMVASTATIN; SITAGLIPTIN PHOSPHATE N 202343 005 6303661

Apr
6699871
Jul
6890898
Feb
6890898
Feb
6890898
Feb
7078381
Feb
7125873
Jul
7125873
Jul
7125873
Jul
7125873
Jul
7326708
Apr
7459428
Feb
8168637
Jun

JUVISYNC

24, 2017

26, 2022

02, 2019

02, 2019

02, 2019

02, 2019

26, 2022

26, 2022

26, 2022

26, 2022

11, 2026

02, 2019

26, 2022

U-1188

DS DP U-1188

U-1189

U-1190

U-1191

U-1188

DP U-1189

DP U-1190

DP U-1192

DP U-1193

DS DP U-1188

U-1189

DP U-1188

SIMVASTATIN; SITAGLIPTIN PHOSPHATE N 202343 006 6303661

Apr
6699871
Jul
6890898
Feb

JUVISYNC

24, 2017

26, 2022

02, 2019

U-1188

DS DP U-1188

U-1189

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ADA 195 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 006 6890898
Feb 02, 2019
6890898
Feb 02, 2019
7078381
Feb 02, 2019
7125873
Jul 26, 2022
7125873
Jul 26, 2022
7125873
Jul 26, 2022
7125873
Jul 26, 2022
7326708
Apr 11, 2026
7459428
Feb 02, 2019
8168637
Jun 26, 2022
APPL/PROD
NO

PATENT NO

PATENT
CODES

DP
DP
DP
DP
DS DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1190
U-1191
U-1188
U-1189
U-1190
U-1192
U-1193
U-1188
U-1189
U-1188

SINCALIDE - KINEVAC
N 017697 001 6803046

Aug 16, 2022

DP

SINECATECHINS - VEREGEN
N 021902 001 5795911
5968973
7858662

Oct 31, 2020

Apr 10, 2017
Oct 02, 2026

U-172
U-172
DP U-172

SIROLIMUS - RAPAMUNE
N 021083 001

ODE

May 28, 2022

SIROLIMUS - RAPAMUNE
N 021110 001 5989591

Mar 11, 2018

DP

ODE

May 28, 2022

SIROLIMUS - RAPAMUNE
N 021110 002 5989591

Mar 11, 2018

DP

ODE

May 28, 2022

SIROLIMUS - RAPAMUNE
N 021110 003 5989591

Mar 11, 2018

DP

ODE

May 28, 2022

SIROLIMUS - RAPAMUNE
N 021110 004 5989591

Mar 11, 2018

DP

ODE

May 28, 2022

SITAGLIPTIN PHOSPHATE - JANUVIA

N 021995 001 6699871
7125873
7125873
7125873
7125873
7326708

Jul
Jul
Jul
Jul
Jul
Apr

26,
26,
26,
26,
26,
11,

2022
2022
2022
2022
2022
2026

DS DP U-774
U-775
U-1036
U-1037
U-1038
DS DP U-802

SITAGLIPTIN PHOSPHATE - JANUVIA

N 021995 002 6699871
7125873
7125873
7125873
7125873
7326708

Jul
Jul
Jul
Jul
Jul
Apr

26,
26,
26,
26,
26,
11,

2022
2022
2022
2022
2022
2026

DS DP U-774
U-775
U-1036
U-1037
U-1038
DS DP U-802

SITAGLIPTIN PHOSPHATE - JANUVIA

N 021995 003 6699871
7125873
7125873
7125873
7125873
7326708

Jul
Jul
Jul
Jul
Jul
Apr

26,
26,
26,
26,
26,
11,

2022
2022
2022
2022
2022
2026

DS DP U-774
U-775
U-1036
U-1037
U-1038
DS DP U-802

SODIUM NITRITE - SODIUM NITRITE

N 203922 001 8568793

Dec 24, 2031

DS DP

ODE

Jan 14, 2018

DS DP U-1419
DS DP

ODE

Jan 14, 2018

SODIUM NITRITE; SODIUM THIOSULFATE - NITHIODOTE

N 201444 001 8496973
Mar 29, 2031
8568793
Dec 24, 2031
SODIUM OXYBATE - XYREM
N 021196 001 6780889
7262219
7668730
7765106

Jul
Jul
Jun
Jun

04,
04,
16,
16,

2020
2020
2024
2024

DP
DP
U-1110
U-1069

ADA 196 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

SODIUM OXYBATE - XYREM

N 021196 001 7765107
7851506
7851506
7895059
8263650
8263650
8324275
8324275
8457988
8589182
8731963
8772306
8859619
8952062
8952062
9050302

PATENT
EXPIRATION
DATE

PATENT
CODES

Jun
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Mar
Dec
Dec
Dec
Mar

U-1070

U-1101

U-1102

U-1110

DP U-1101

DP U-1102

U-1101

U-1102

U-1110

U-1110

U-1110

U-1532

DP

U-1101

U-1102

U-1532

16,
22,
22,
17,
22,
22,
22,
22,
17,
17,
17,
15,
22,
22,
22,
15,

2024
2019
2019
2022
2019
2019
2019
2019
2022
2022
2022
2033
2019
2019
2019
2033

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - OSMOPREP

N 021892 001 7687075
Jun 22, 2028
DS DP

SODIUM THIOSULFATE - SODIUM THIOSULFATE

N 203923 001 8496973
Mar 29, 2031
SOFOSBUVIR - SOVALDI

N 204671 001 7964580
8334270
8580765
8618076
8633309
8889159
9085573

Mar
Mar
Mar
Dec
Mar
Mar
Mar

26,
21,
21,
11,
26,
26,
21,

2029
2028
2028
2030
2029
2029
2028

DS DP U-1419

ODE

Jan 14, 2018

DS
DS
DS
DS
DS

NCE

Dec 06, 2018

DP
DP
DP
DP
DP
DP
DS DP

SOLIFENACIN SUCCINATE - VESICARE

N 021518 001 6017927
Nov 19, 2018

DS DP

SOLIFENACIN SUCCINATE - VESICARE

N 021518 002 6017927
Nov 19, 2018

DS DP

SOMATROPIN RECOMBINANT - SAIZEN

N 019764 002 5898030
Apr 27, 2016

DP

SOMATROPIN RECOMBINANT - SAIZEN

N 019764 003 5898030
Apr 27, 2016

DP

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE

N 020280 001 6152897
Nov 20, 2018
DP

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE

N 020280 002 6152897
Nov 20, 2018
DP

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE

N 020280 003 6152897
Nov 20, 2018
DP

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE

N 020280 005 6152897
Nov 20, 2018
DP

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE

N 020280 008 6152897
Nov 20, 2018
DP

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE

N 020280 009 6152897
Nov 20, 2018
DP

SOMATROPIN RECOMBINANT - SEROSTIM

N 020604 001 5898030
Apr 27, 2016

DP

SOMATROPIN RECOMBINANT - SEROSTIM

N 020604 002 5898030
Apr 27, 2016

DP

U-1470
U-1470

U-1470

U-1470

U-1470

U-1470

U-1470

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 197 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

SOMATROPIN RECOMBINANT - SEROSTIM

N 020604 003 5898030
Apr 27, 2016

DP

SOMATROPIN RECOMBINANT - SEROSTIM

N 020604 004 5898030
Apr 27, 2016

DP

SOMATROPIN RECOMBINANT - NORDITROPIN

N 021148 001 5849700
Dec 15, 2015
5849704
Dec 15, 2015

U-340

SOMATROPIN RECOMBINANT - NORDITROPIN

N 021148 002 5849700
Dec 15, 2015
5849704
Dec 15, 2015

U-340

SOMATROPIN RECOMBINANT - NORDITROPIN

N 021148 003 5849700
Dec 15, 2015
5849704
Dec 15, 2015

U-340

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N 021148 004 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6004297
Jan 28, 2019
6235004
Jan 28, 2019
RE41956
Jan 21, 2021

U-340
DP U-340
DP
DP
DP

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N 021148 005 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6004297
Jan 28, 2019
6235004
Jan 28, 2019
RE41956
Jan 21, 2021

U-340
DP U-340
DP
DP
DP

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N 021148 006 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6004297
Jan 28, 2019
6235004
Jan 28, 2019
RE41956
Jan 21, 2021

U-340
DP U-340
DP
DP
DP

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N 021148 007 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6004297
Jan 28, 2019
8841252
Dec 26, 2017
RE41956
Jan 21, 2021
RE43834
Jan 28, 2019

U-340
DP U-340
DP
DP
DP
DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N 021148 008 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6899699
Jan 02, 2022
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8841252
Dec 26, 2017
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

U-1041
DP U-1041
DP
DP
DP
DP
DP
DP
DP
DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N 021148 009 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6899699
Jan 02, 2022
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8841252
Dec 26, 2017
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

U-1041
DP U-1041
DP
DP
DP
DP
DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 198 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO
N 021148 009 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6899699
Jan 02, 2022
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8841252
Dec 26, 2017
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032
APPL/PROD
NO

PATENT NO

PATENT
CODES

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1041
DP U-1041
DP
DP
DP
DP
DP
DP
DP
DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N 021148 010 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6899699
Jan 02, 2022
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8841252
Dec 26, 2017
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

U-1041
DP U-1041
DP
DP
DP
DP
DP
DP
DP
DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N 021148 011 5849700
Dec 15, 2015
5849704
Dec 15, 2015
6899699
Jan 02, 2022
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8841252
Dec 26, 2017
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

U-1041
DS DP U-1041
DP
DP
DP
DP
DP
DP
DP
DP

SOMATROPIN RECOMBINANT - ZORBTIVE

N 021597 004 5898030
Apr 27, 2016

PATENT
DELIST
REQUESTED

DP

SONIDEGIB PHOSPHATE - ODOMZO

N 205266 001 8063043
8178563

Sep 15, 2029

Feb 06, 2029

DS DP
DS
U-1722

NCE

Jul 24, 2020

SORAFENIB TOSYLATE - NEXAVAR

N 021923 001 7235576
7351834
7897623
8124630
8618141
8841330
8877933

Jan
Jan
Jan
Jan
Feb
Jan
Dec

DS DP
DS
DP

I-677
ODE

Nov 22, 2016

Nov 22, 2020

ODE

Jul 02, 2016

M-152
NCE

Nov 30, 2017

Jan 18, 2016

12,
12,
12,
12,
11,
12,
24,

2020
2020
2020
2020
2023
2020
2027

U-1459
U-1480
U-1696
DS DP U-1624

SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE

N 022306 001
SPINOSAD - NATROBA
N 022408 001 6063771
6342482
7030095

Jul 25, 2023

Jun 22, 2019
Jul 02, 2021

DP U-1670
DP U-1105
DP U-1105

STAVUDINE - ZERIT XR
N 021453 001 7135465

Feb 18, 2023

DP U-167

STAVUDINE - ZERIT XR
N 021453 002 7135465

Feb 18, 2023

DP U-167

STAVUDINE - ZERIT XR
N 021453 003 7135465

Feb 18, 2023

DP U-167

ADA 199 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

STAVUDINE - ZERIT XR
N 021453 004 7135465

PATENT
EXPIRATION
DATE

PATENT
CODES

Feb 18, 2023

DP U-167

SUCROFERRIC OXYHYDROXIDE - VELPHORO

N 205109 001 6174442
Dec 19, 2016

DS

SUGAMMADEX SODIUM - BRIDION

N 022225 001 6949527
7265009
RE44733

Jan 27, 2021

Aug 07, 2020
Jan 27, 2021

U-1795
U-1795
DS DP U-1794

SUGAMMADEX SODIUM - BRIDION

N 022225 002 6949527
7265009
RE44733

Jan 27, 2021

Aug 07, 2020
Jan 27, 2021

U-1795
U-1795
DS DP U-1794

U-1468

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES - LUMASON

N 203684 001
SUMATRIPTAN SUCCINATE - SUMAVEL DOSEPRO
N 022239 001 5957886
Mar 08,
6135979
Mar 21,
6174304
Dec 13,
6251091
Dec 09,
6280410
Mar 27,
6681810
Dec 13,
7776007
Nov 22,
7901385
Jul 31,
8118771
Aug 10,
8241243
Aug 10,
8241244
Nov 21,
8267903
Mar 18,
8287489
Dec 06,
8343130
Oct 18,
8491524
Nov 21,

2016
2017
2015
2016
2017
2015
2026
2026
2023
2023
2022
2023
2024
2022
2022

Aug 26, 2027

DP U-1083

SUMATRIPTAN SUCCINATE - ZECUITY

N 202278 001 6745071
7973058
8155737
8366600
8470853
8597272
8983594

Feb
Apr
Apr
Apr
Apr
Apr
Nov

DP

SUNITINIB MALATE - SUTENT

N 021938 001 6573293
7125905
7211600

Feb 15, 2021

Feb 15, 2021
Dec 22, 2020

DS DP U-1154
DS DP
U-883

SUNITINIB MALATE - SUTENT

N 021938 002 6573293
7125905
7211600

Feb 15, 2021

Feb 15, 2021
Dec 22, 2020

DS DP U-1154
DS DP
U-883

SUNITINIB MALATE - SUTENT

N 021938 003 6573293
7125905
7211600

Feb 15, 2021

Feb 15, 2021
Dec 22, 2020

DS DP U-1154
DS DP
U-883

SUNITINIB MALATE - SUTENT

N 021938 004 6573293
7125905
7211600

Feb 15, 2021

Feb 15, 2021
Dec 22, 2020

DS DP U-1154
DS DP
U-883

2023
2027
2027
2029
2027
2027
2030

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NP

Nov 27, 2016

NCE

Oct 10, 2019

NDF

Jan 17, 2016

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

SUMATRIPTAN SUCCINATE - ALSUMA

N 022377 001 7811254

21,
12,
12,
21,
12,
12,
19,

PATENT
DELIST
REQUESTED

U-1328
U-1328
U-1327
U-1328
DP
DP U-1328

ADA 200 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

SUVOREXANT - BELSOMRA

N 204569 001 7951797

Nov 20, 2029

DS DP U-620

NCE

Aug 13, 2019

SUVOREXANT - BELSOMRA

N 204569 002 7951797

Nov 20, 2029

DS DP U-620

NCE

Aug 13, 2019

SUVOREXANT - BELSOMRA

N 204569 003 7951797

Nov 20, 2029

DS DP U-620

NCE

Aug 13, 2019

SUVOREXANT - BELSOMRA

N 204569 004 7951797

Nov 20, 2029

DS DP U-620

NCE

Aug 13, 2019

TACROLIMUS - ASTAGRAF XL

N 204096 001 6440458
6576259
6884433
8551522

Mar
Mar
Mar
Mar

25,
25,
25,
25,

2019
2019
2019
2019

DP
DP U-1420

DP U-1420

DP

NDF

Jul 19, 2016

TACROLIMUS - ASTAGRAF XL

N 204096 002 6440458
6576259
6884433
8551522

Mar
Mar
Mar
Mar

25,
25,
25,
25,

2019
2019
2019
2019

DP
DP U-1420

DP U-1420

DP

NDF

Jul 19, 2016

TACROLIMUS - ASTAGRAF XL

N 204096 003 6440458
6576259
6884433
8551522

Mar
Mar
Mar
Mar

25,
25,
25,
25,

2019
2019
2019
2019

DP
DP U-1420

DP U-1420

DP

NDF

Jul 19, 2016

TACROLIMUS - ENVARSUS XR

N 206406 001 7994214
8486993
8586084
8591946
8617599
8623410
8623411
8664239
8685998
8889185
8889186
9161907

Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug
Aug

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024
2024

DP
DP U-1752

U-1752

DP

DP

DP

U-1752

U-1752

DP U-1752

U-1752

U-1752

DP U-1752

ODE

Jul 10, 2022

TACROLIMUS - ENVARSUS XR

N 206406 002 7994214
8486993
8586084
8591946
8617599
8623410
8623411
8664239
8685998
8889185
8889186
9161907

Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug
Aug

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024
2024

DP
DP U-1752

U-1752

DP

DP

DP

U-1752

U-1752

DP U-1752

U-1752

U-1752

DP U-1752

ODE

Jul 10, 2022

TACROLIMUS - ENVARSUS XR

N 206406 003 7994214
8486993
8586084
8591946
8617599
8623410
8623411
8664239
8685998
8889185
8889186

Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024

DP
DP U-1752

U-1752

DP

DP

DP

U-1752

U-1752

DP U-1752

U-1752

U-1752

ODE

Jul 10, 2022

ADA 201 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD

NO

PATENT

EXPIRATION

DATE

PATENT
CODES

TACROLIMUS - ENVARSUS XR

N 206406 003 9161907

Aug 30, 2024

DP U-1752

TADALAFIL - CIALIS

N 021368 001 5859006

6140329

6140329

6821975

6821975

6821975

6943166

6943166

6943166

7182958

7182958

Nov
Jul
Jul
Nov
Nov
Nov
Apr
Apr
Apr
Apr
Apr

21,
11,
11,
19,
19,
19,
26,
26,
26,
26,
26,

2017

2016

2016

2020

2020

2020

2020

2020

2020

2020

2020

DS DP

DP U-155

DP U-1184

DS DP U-533

DS DP U-614

DS DP U-1184

U-155

U-614

U-1184

DP U-155

DP U-1184

TADALAFIL - CIALIS

N 021368 002 5859006

6140329

6821975

6821975

6943166

6943166

7182958

Nov
Jul
Nov
Nov
Apr
Apr
Apr

21,
11,
19,
19,
26,
26,
26,

2017

2016

2020

2020

2020

2020

2020

DS DP

DP U-155

DS DP U-533

DS DP U-614

U-155

U-614

DP U-155

TADALAFIL - CIALIS

N 021368 003 5859006

6140329

6821975

6821975

6943166

7182958

Nov
Jul
Nov
Nov
Apr
Apr

21,
11,
19,
19,
26,
26,

2017

2016

2020

2020

2020

2020

DS DP

DP U-155

DS DP U-533

DS DP U-614

U-614

DP U-155

TADALAFIL - CIALIS

N 021368 004 5859006

6140329

6821975

6821975

6943166

7182958

Nov
Jul
Nov
Nov
Apr
Apr

21,
11,
19,
19,
26,
26,

2017

2016

2020

2020

2020

2020

DS DP

DP U-155

DS DP U-533

DS DP U-614

U-155

DP U-155

TADALAFIL - ADCIRCA

N 022332 001 5859006

6821975

7182958

Nov 21, 2017

Nov 19, 2020

Apr 26, 2020

DS DP U-975

DS DP

DP

ODE

May 22, 2016

TAFLUPROST - ZIOPTAN

N 202514 001 5886035

Dec 18, 2017

DS DP U-778

NCE

Feb 10, 2017

TALIGLUCERASE ALFA - ELELYSO

N 022458 001 8227230

8741620

8790641

8790641

Feb
Feb
Oct
Oct

2024

2024

2025

2025

DS DP

DS DP

NCE
NPP

May 01, 2017

Aug 27, 2017

TAMOXIFEN CITRATE - SOLTAMOX

N 021807 001 6127425

Jun 26, 2018

DP

PATENT NO

24,
24,
18,
18,

U-1564

U-1574

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N 022304 001 6071970
Jun 06, 2017
7994364
Jun 27, 2025
RE39593
Aug 05, 2022

U-931

DS DP U-931

DS DP U-931

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N 022304 002 6071970
Jun 06, 2017
7994364
Jun 27, 2025
RE39593
Aug 05, 2022

U-931

DS DP U-931

DS DP U-931

PATENT

DELIST

REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ADA 202 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT

EXPIRATION

DATE

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N 022304 003 6071970
Jun 06, 2017

7994364
Jun 27, 2025

RE39593
Aug 05, 2022

U-931
DS DP U-931
DS DP U-931

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N 200533 001 6071970
Jun 06,
6071970
Jun 06,
7994364
Jun 27,
7994364
Jun 27,
8075872
Nov 20,
8114383
Oct 10,
8309060
Nov 20,
8309060
Nov 20,
8420056
Nov 20,
8536130
Sep 22,
RE39593
Aug 05,
RE39593
Aug 05,

2017

2017

2025

2025

2023

2024

2023

2023

2023

2028

2022

2022

U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1739
DS DP U-1178
DS DP U-1276

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N 200533 002 6071970
Jun 06,
6071970
Jun 06,
7994364
Jun 27,
7994364
Jun 27,
8075872
Nov 20,
8114383
Oct 10,
8309060
Nov 20,
8309060
Nov 20,
8420056
Nov 20,
8536130
Sep 22,
RE39593
Aug 05,
RE39593
Aug 05,

2017

2017

2025

2025

2023

2024

2023

2023

2023

2028

2022

2022

U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1739
DS DP U-1178
DS DP U-1276

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N 200533 003 6071970
Jun 06,
6071970
Jun 06,
7994364
Jun 27,
7994364
Jun 27,
8075872
Nov 20,
8114383
Oct 10,
8309060
Nov 20,
8309060
Nov 20,
8420056
Nov 20,
8536130
Sep 22,
RE39593
Aug 05,
RE39593
Aug 05,

2017

2017

2025

2025

2023

2024

2023

2023

2023

2028

2022

2022

U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1739
DS DP U-1178
DS DP U-1276

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N 200533 004 6071970
Jun 06,
6071970
Jun 06,
7994364
Jun 27,
7994364
Jun 27,
8075872
Nov 20,
8114383
Oct 10,
8309060
Nov 20,
8309060
Nov 20,
8420056
Nov 20,
8536130
Sep 22,
RE39593
Aug 05,
RE39593
Aug 05,

2017

2017

2025

2025

2023

2024

2023

2023

2023

2028

2022

2022

U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1739
DS DP U-1178
DS DP U-1276

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N 200533 005 6071970
Jun 06,
6071970
Jun 06,
7994364
Jun 27,
7994364
Jun 27,
8075872
Nov 20,
8114383
Oct 10,
8309060
Nov 20,
8309060
Nov 20,

2017

2017

2025

2025

2023

2024

2023

2023

U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

I-656

Aug 28, 2015

I-656

Aug 28, 2015

I-656

Aug 28, 2015

I-656

Aug 28, 2015

I-656

Aug 28, 2015

ADA 203 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N 200533 005 8420056
Nov 20, 2023
8536130
Sep 22, 2028
RE39593
Aug 05, 2022
RE39593
Aug 05, 2022

U-1739

DS DP U-1178

DS DP U-1276

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N 203794 001 6071970
Jun 06, 2017
7994364
Jun 27, 2025
RE39593
Aug 05, 2022

U-1289

DS DP U-1289

DS DP U-1289

TASIMELTEON - HETLIOZ

N 205677 001 5856529
8785492
9060995

Dec 09, 2017

Jan 25, 2033
Jan 25, 2033

DS DP U-1486
U-1486
U-1710

TAVABOROLE - KERYDIN

N 204427 001 7582621
7767657

May 26, 2027

May 22, 2027

DP

TAZAROTENE - FABIOR

N 202428 001 8808716

Feb 24, 2030

DP

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

U-718

TECHNETIUM TC-99M SULFUR COLLOID KIT - AN-SULFUR COLLOID

N 017858 001
TECHNETIUM TC-99M TEBOROXIME KIT - CARDIOTEC

N 019928 001 6056941
Jul 28, 2019

NCE
ODE

Jan 31, 2019

Jan 31, 2021

NCE

Jul 07, 2019

ODE

Aug 13, 2019

DP

TECHNETIUM TC-99M TILMANOCEPT - LYMPHOSEEK KIT

N 202207 001 6409990
May 12, 2020

DS

I-687
NCE
ODE

Jun 13, 2017

Mar 13, 2018

Jun 13, 2021

TEDIZOLID PHOSPHATE - SIVEXTRO

N 205435 001 7816379
8420676
8426389

Feb 23, 2028

Feb 23, 2028
Dec 31, 2030

DS DP U-282
DS DP U-282
DS DP U-282

NCE
GAIN

Jun 20, 2019

Jun 20, 2024

TEDIZOLID PHOSPHATE - SIVEXTRO

N 205436 001 7816379
8420676
8426389

Feb 23, 2028

Feb 23, 2028
Dec 31, 2030

DS DP U-282
DS DP U-282
DS DP U-282

NCE
GAIN

Jun 20, 2019

Jun 20, 2024

DS DP U-1320
DP U-1320
U-1320

U-1320

NCE
ODE

Dec 21, 2017

Dec 21, 2019

DS DP

NCE

May 23, 2016

I-673

Jun 21, 2016

TEDUGLUTIDE RECOMBINANT - GATTEX KIT

N 203441 001 5789379
Apr 14, 2016
7056886
Sep 18, 2022
7847061
Nov 01, 2025
9060992
Nov 01, 2025
TELAPREVIR - INCIVEK

N 201917 001 7820671
8431615
8529882

Feb 25, 2025

May 30, 2028
Aug 31, 2021

TELAVANCIN HYDROCHLORIDE - VIBATIV

N 022110 001 6635618
Sep
6858584
Aug
6872701
Jun
7008923
May
7208471
May
7351691
May
7531623
Jan
7544364
May
7700550
May
8101575
May
8158580
May

11,
24,
05,
06,
01,
01,
01,
01,
01,
01,
01,

2023
2022
2021
2021
2021
2021
2027
2021
2021
2021
2021

U-1398

U-1398

DS DP U-728
DP

DP

U-1005

DS DP

DS DP U-728

DS

DP

U-282

DP

DP

ADA 204 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
TELAVANCIN HYDROCHLORIDE - VIBATIV
N 022110 002 6635618
Sep 11, 2023
6858584
Aug 24, 2022
6872701
Jun 05, 2021
7008923
May 06, 2021
7208471
May 01, 2021
7351691
May 01, 2021
7531623
Jan 01, 2027
7544364
May 01, 2021
7700550
May 01, 2021
8101575
May 01, 2021
8158580
May 01, 2021

DS DP U-728
DP
DP
U-1005
DS DP
DS DP U-728
DS
DP
U-282
DP
DP

I-673

Jun 21, 2016

TELBIVUDINE - TYZEKA
N 022011 001 6395716
6444652
6566344
6569837
6569837
7589079
7795238
7858594

Aug
Aug
Aug
Oct
Oct
Sep
Aug
Sep

10,
10,
10,
25,
25,
11,
10,
11,

2019
2019
2019
2020
2020
2023
2019
2023

U-782
U-782
U-782
U-782
U-999
DS DP U-999
U-999
DS DP U-999

M-124

Jan 28, 2016

TELBIVUDINE - TYZEKA
N 022154 001 6395716
6444652
6566344
6569837
7795238
7858594

Aug
Aug
Aug
Oct
Aug
Sep

10,
10,
10,
25,
10,
11,

2019
2019
2019
2020
2019
2023

U-999
U-999
U-999
U-999
U-999
DS DP U-999

M-124

Jan 28, 2016

TELITHROMYCIN - KETEK
N 021144 001 5635485
D459798

Apr 01, 2018

Sep 24, 2015

DS DP U-578
DP

TELITHROMYCIN - KETEK
N 021144 002 5635485
D459798

Apr 01, 2018

Sep 24, 2015

DS DP U-578
DP

TELMISARTAN - MICARDIS
N 020850 001 6358986

Jan 10, 2020

TELMISARTAN - MICARDIS
N 020850 002 6358986
7998953
8003679

Jan 10, 2020

Jun 06, 2020
Oct 06, 2022

TELMISARTAN - MICARDIS
N 020850 003 6358986

Jan 10, 2020

TEMOZOLOMIDE - TEMODAR
N 022277 001 6987108
7786118
8623868

Sep 08, 2023

Feb 21, 2023
Feb 21, 2023

TEMSIROLIMUS - TORISEL
N 022088 001 5362718
5362718*PED
8026276
8299116
8455539
8455539*PED
8722700
8722700*PED
8791097
8791097
8791097*PED
RE44768
RE44768*PED

Feb
Aug
Jan
Jul
Jul
Jan
Jul
Jan
May
May
Nov
Feb
Aug

PED

Nov 30, 2015

APPL/PROD
NO

PATENT NO

15,
15,
20,
25,
25,
25,
25,
25,
10,
10,
10,
15,
15,

2019
2019
2026
2023
2023
2024
2023
2024
2032
2032
2032
2019
2019

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1177
U-1176

DP
DP
DP

DS DP

DP
DP
DP
DP
U-1550
U-1551
DS DP

ADA 205 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N 021356 001 5922695
Jul 25, 2017
5922695
Jul 25, 2017
5922695
Jul 25, 2017
5922695
Jul 25, 2017
5922695
Jul 25, 2017
5935946
Jul 25, 2017
5935946
Jul 25, 2017
5935946
Jul 25, 2017
5935946
Jul 25, 2017
5935946
Jul 25, 2017
5977089
Jul 25, 2017
5977089
Jul 25, 2017
5977089
Jul 25, 2017
5977089
Jul 25, 2017
5977089
Jul 25, 2017
6043230
Jul 25, 2017
6043230
Jul 25, 2017
6043230
Jul 25, 2017
6043230
Jul 25, 2017
6043230
Jul 25, 2017
PATENT NO

PATENT
CODES
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N 021356 002 5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,

2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017

DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N 021356 003 5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,

2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017

DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N 021356 004 5922695
Jul 25, 2017
5922695
Jul 25, 2017
5922695
Jul 25, 2017

DS
DS
DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

M-128
NPP
ODE
PED
PED

Jul
Aug
Mar
Jul
Sep

24,
16,
24,
18,
24,

2016

2015

2017

2015

2017

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-248
U-250
U-256
U-999
U-1275
U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

M-128
NPP
ODE
PED
PED

Jul
Aug
Mar
Jul
Sep

24,
16,
24,
18,
24,

2016

2015

2017

2015

2017

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-248
U-250
U-256
U-999
U-1275
U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

M-128
NPP
ODE
PED
PED

Jul
Aug
Mar
Jul
Sep

24,
16,
24,
18,
24,

2016

2015

2017

2015

2017

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-248
U-250
U-256
U-999
U-1275
U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

U-248
U-250
U-256

M-128
NPP
ODE

Jul 24, 2016

Aug 16, 2015
Mar 24, 2017

ADA 206 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N 021356 004 5922695
Jul 25, 2017
5922695
Jul 25, 2017
5935946
Jul 25, 2017
5935946
Jul 25, 2017
5935946
Jul 25, 2017
5935946
Jul 25, 2017
5935946
Jul 25, 2017
5977089
Jul 25, 2017
5977089
Jul 25, 2017
5977089
Jul 25, 2017
5977089
Jul 25, 2017
5977089
Jul 25, 2017
6043230
Jul 25, 2017
6043230
Jul 25, 2017
6043230
Jul 25, 2017
6043230
Jul 25, 2017
6043230
Jul 25, 2017
PATENT NO

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N 022577 001 5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,

2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017
2017

PATENT
CODES
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS

DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

TERIFLUNOMIDE - AUBAGIO

N 202992 001 6794410
8802735
9186346

Apr 15, 2022

Sep 14, 2030
Feb 04, 2034

DP

TERIFLUNOMIDE - AUBAGIO

N 202992 002 6794410
8802735
9186346

Apr 15, 2022

Sep 14, 2030
Feb 04, 2034

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-999
U-1275
U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

PED
PED

Jul 18, 2015

Sep 24, 2017

U-248
U-250
U-256
U-999
U-1275
U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

U-248

U-250

U-256

U-999

U-1275

M-128
NPP
ODE
PED
PED

Jul
Aug
Mar
Jul
Sep

U-1285

NCE

Sep 12, 2017

NCE

Sep 12, 2017

24,
16,
24,
18,
24,

2016

2015

2017

2015

2017

U-1786

U-1285
U-1786

TERIPARATIDE RECOMBINANT HUMAN - FORTEO

N 021318 001 6770623
Dec 08, 2018
6977077
Aug 19, 2019
7144861
Dec 08, 2018
7163684
Aug 19, 2019
7351414
Aug 19, 2019
7517334
Mar 25, 2025
7550434
Dec 08, 2018

DP U-597

U-597

DP

U-790

U-865

DP

DP U-982

TERIPARATIDE RECOMBINANT HUMAN - FORTEO

N 021318 002 6770623
Dec 08, 2018
6977077
Aug 19, 2019
6977077
Aug 19, 2019
7144861
Dec 08, 2018
7163684
Aug 19, 2019
7163684
Aug 19, 2019
7351414
Aug 19, 2019
7351414
Aug 19, 2019
7517334
Mar 25, 2025

DP U-982

U-982

U-994

DP

U-983

U-994

U-984

U-994

DP

ADA 207 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
TERIPARATIDE RECOMBINANT HUMAN - FORTEO

N 021318 002 7550434

Dec 08, 2018

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP U-982

TESAMORELIN ACETATE - EGRIFTA

N 022505 001 5861379

7144577

7316997

May 26, 2020

Jul 14, 2020

Aug 14, 2023

DS DP U-1100
U-1100

U-1100

NCE

Nov 10, 2015

TESAMORELIN ACETATE - EGRIFTA

N 022505 002 7144577

7316997

Jul 14, 2020

Aug 14, 2023

U-1100
U-1100

NCE

Nov 10, 2015

TESTOSTERONE - TESTODERM

N 019762 001 5840327

Aug 15, 2016

TESTOSTERONE - TESTODERM

N 019762 002 5840327

Aug 15, 2016

TESTOSTERONE - TESTODERM TTS

N 020791 001 6348210

Nov 10, 2019

U-440

TESTOSTERONE - ANDROGEL

N 021015 001 6503894

9125816

9132089

Aug 30, 2020

Aug 30, 2020

Aug 30, 2020

U-490

U-490

U-490

TESTOSTERONE - ANDROGEL

N 021015 002 6503894

9125816

9132089

Aug 30, 2020

Aug 30, 2020

Aug 30, 2020

U-490

U-490

U-490

TESTOSTERONE - ANDROGEL

N 021015 003 6503894

9125816

9132089

Aug 30, 2020

Aug 30, 2020

Aug 30, 2020

U-490

U-490

U-490

TESTOSTERONE - TESTIM

N 021454 001 7320968

7608605

7608606

7608607

7608608

7608609

7608610

7935690

8063029

8178518

Jan
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

2025

2023

2023

2023

2023

2023

2023

2023

2023

2023

U-843

U-1009

U-1009

U-1009

U-1009

U-1009

U-1009

U-1009

U-843

DP

TESTOSTERONE - FORTESTA

N 021463 001 6319913

6579865

Nov 09, 2018

Nov 09, 2018

DP

TESTOSTERONE - STRIANT

N 021543 001 6248358

Aug 23, 2019

TESTOSTERONE - ANDROGEL

N 022309 001 6503894

8466136

8466137

8466138

8486925

8729057

8741881

8754070

8759329

9125816

9132089

Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug

18,
21,
21,
21,
21,
21,
21,
21,
21,
21,

30,
12,
12,
12,
12,
12,
12,
12,
12,
30,
30,

2020

2026

2026

2026

2026

2026

2026

2026

2026

2020

2020

U-490

U-527

U-1103

DP

U-1103

U-1103

DP

DP

U-1103

DP

DP

U-1103

U-1103

ADA 208 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

TESTOSTERONE - ANDROGEL
N 022309 002 6503894
8466136
8466137
8466138
8486925
8729057
8741881
8754070
8759329
9125816
9132089

Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug

30,
12,
12,
12,
12,
12,
12,
12,
12,
30,
30,

2020
2026
2026
2026
2026
2026
2026
2026
2026
2020
2020

TESTOSTERONE - ANDROGEL
N 022309 003 6503894
8466136
8466137
8466138
8486925
8729057
8741881
8754070
8759329
9125816
9132089

Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug

30,
12,
12,
12,
12,
12,
12,
12,
12,
30,
30,

2020
2026
2026
2026
2026
2026
2026
2026
2026
2020
2020

TESTOSTERONE - AXIRON
N 022504 001 6299900
6818226
6923983
8071075
8419307
8435944
8784878
8807861
8993520
9180194

Feb
Feb
Feb
Feb
Feb
Sep
Jul
Feb
Jun
Jun

19,
19,
19,
19,
26,
27,
13,
26,
02,
02,

2017
2017
2017
2017
2027
2027
2023
2027
2026
2026

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1103
DP
U-1103
U-1103
DP
DP
U-1103
DP
DP
U-1103
U-1103

U-1103
DP
U-1103
U-1103
DP
DP
U-1103
DP
DP
U-1103
U-1103

DP
DP
DP
DP

U-1103
U-1103
U-1103
U-1103
U-1386
U-1390
DP U-1545
DP U-1563
U-1390
U-1390

TESTOSTERONE - TESTOSTERONE
N 203098 001

NP

Jan 31, 2016

TESTOSTERONE - TESTOSTERONE
N 203098 002

NP

Jan 31, 2016

TESTOSTERONE - TESTOSTERONE
N 203098 003

NP

Jan 31, 2016

TESTOSTERONE - VOGELXO
N 204399 002 8785426

Feb 11, 2034

DP U-1531

NP

Jun 04, 2017

TESTOSTERONE - VOGELXO
N 204399 003 8785426

Feb 11, 2034

DP U-1531

NP

Jun 04, 2017

TESTOSTERONE - NATESTO
N 205488 001 8574622
8784869
8784882
8877230

Feb
Feb
Feb
Feb

DP
DP
DP U-1557
U-1616

NP

May 28, 2017

DP

NP

Mar 05, 2017

TETRABENAZINE - XENAZINE
N 021894 001

ODE

Aug 15, 2015

TETRABENAZINE - XENAZINE
N 021894 002

ODE

Aug 15, 2015

04,
04,
04,
04,

2024
2024
2024
2024

TESTOSTERONE UNDECANOATE - AVEED

N 022219 001 7718640
Mar 14, 2027
8338395
Feb 27, 2026

U-1500

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 209 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

THALIDOMIDE - THALOMID

N 020785 001 6045501
6045501
6315720
6315720
6561976
6561976
6561977
6561977
6755784
6755784
6869399
6869399
6869399
6869399
6908432
6908432
7141018
7141018
7141018
7141018
7230012
7435745
7874984
7874984
7874984
7874984
7874984
7959566
8204763
8315886
8589188
8626531

Aug
Aug
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Dec
Nov
Aug
Aug
Aug
Aug
Aug
Oct
Aug
Oct
Aug
Oct

28,
28,
23,
23,
28,
28,
23,
23,
23,
23,
23,
23,
23,
23,
28,
28,
23,
23,
23,
23,
09,
03,
28,
28,
28,
28,
28,
23,
28,
23,
28,
23,

2018
2018
2020
2020
2018
2018
2020
2020
2020
2020
2020
2020
2020
2020
2018
2018
2020
2020
2020
2020
2023
2017
2018
2018
2018
2018
2018
2020
2018
2020
2018
2020

THALIDOMIDE - THALOMID

N 020785 002 6045501
6045501
6315720
6315720
6561976
6561976
6561977
6561977
6755784
6755784
6869399
6869399
6869399
6869399
6908432
6908432
7141018
7141018
7141018
7141018
7230012
7435745
7874984
7874984
7874984
7874984
7874984
7959566
8204763
8315886
8589188
8626531

Aug
Aug
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Dec
Nov
Aug
Aug
Aug
Aug
Aug
Oct
Aug
Oct
Aug
Oct

28,
28,
23,
23,
28,
28,
23,
23,
23,
23,
23,
23,
23,
23,
28,
28,
23,
23,
23,
23,
09,
03,
28,
28,
28,
28,
28,
23,
28,
23,
28,
23,

2018
2018
2020
2020
2018
2018
2020
2020
2020
2020
2020
2020
2020
2020
2018
2018
2020
2020
2020
2020
2023
2017
2018
2018
2018
2018
2018
2020
2018
2020
2018
2020

PATENT
CODES
U-371

U-731

U-442

U-731

U-371

U-731

U-371

U-731

U-371

U-731

U-371

U-731

U-732

U-733

U-371

U-731

U-371

U-731

U-732

U-733

DP

U-899

U-371

U-442

U-732

U-733

U-1109

U-1155

U-1249

U-1249

U-1465

U-1465

U-371

U-731

U-442

U-731

U-371

U-731

U-371

U-731

U-371

U-731

U-371

U-731

U-732

U-733

U-371

U-731

U-371

U-731

U-732

U-733

DP

U-899

U-371

U-442

U-732

U-733

U-1109

U-1155

U-1249

U-1249

U-1465

U-1465

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

ADA 210 of 225

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

THALIDOMIDE - THALOMID

N 020785 003 6045501
6045501
6315720
6315720
6561976
6561976
6561977
6561977
6755784
6755784
6869399
6869399
6869399
6869399
6908432
6908432
7141018
7141018
7141018
7141018
7230012
7435745
7874984
7874984
7874984
7874984
7874984
7959566
8204763
8315886
8589188
8626531

Aug
Aug
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Dec
Nov
Aug
Aug
Aug
Aug
Aug
Oct
Aug
Oct
Aug
Oct

28,
28,
23,
23,
28,
28,
23,
23,
23,
23,
23,
23,
23,
23,
28,
28,
23,
23,
23,
23,
09,
03,
28,
28,
28,
28,
28,
23,
28,
23,
28,
23,

2018
2018
2020
2020
2018
2018
2020
2020
2020
2020
2020
2020
2020
2020
2018
2018
2020
2020
2020
2020
2023
2017
2018
2018
2018
2018
2018
2020
2018
2020
2018
2020

THALIDOMIDE - THALOMID

N 020785 004 6045501
6315720
6561976
6561977
6755784
6869399
6908432
7141018
7435745
7874984
7874984
7874984
7874984
7874984
7959566
8204763
8315886
8589188
8626531

Aug
Oct
Aug
Oct
Oct
Oct
Aug
Oct
Nov
Aug
Aug
Aug
Aug
Aug
Oct
Aug
Oct
Aug
Oct

28,
23,
28,
23,
23,
23,
28,
23,
03,
28,
28,
28,
28,
28,
23,
28,
23,
28,
23,

2018
2020
2018
2020
2020
2020
2018
2020
2017
2018
2018
2018
2018
2018
2020
2018
2020
2018
2020

THYROTROPIN ALFA - THYROGEN

N 020898 001 5840566

Nov 24, 2015

TIAGABINE HYDROCHLORIDE - GABITRIL

N 020646 001 5866590
Apr 29, 2016

5958951
Jun 10, 2017

TIAGABINE HYDROCHLORIDE - GABITRIL

N 020646 002 5866590
Apr 29, 2016

5958951
Jun 10, 2017

TIAGABINE HYDROCHLORIDE - GABITRIL

N 020646 003 5866590
Apr 29, 2016

5958951
Jun 10, 2017

PATENT
CODES
U-371

U-731

U-442

U-731

U-371

U-731

U-371

U-731

U-371

U-731

U-371

U-731

U-732

U-733

U-371

U-731

U-371

U-731

U-732

U-733

DP

U-899

U-371

U-442

U-732

U-733

U-1109

U-1155

U-1249

U-1249

U-1465

U-1465

U-731

U-731

U-731

U-731

U-731

U-731

U-731

U-731

U-899

U-371

U-442

U-732

U-733

U-1109

U-1155

U-1249

U-1249

U-1465

U-1465

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ADA 211 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT

EXPIRATION

DATE

TIAGABINE HYDROCHLORIDE - GABITRIL

N 020646 004 5866590
Apr 29, 2016

5958951
Jun 10, 2017

PATENT NO

PATENT
CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

TIAGABINE HYDROCHLORIDE - GABITRIL

N 020646 005 5866590

Apr 29, 2016

5958951

Jun 10, 2017

TICAGRELOR - BRILINTA

N 022433 001 6251910

6525060

7250419

7265124

8425934

Jul
Dec
Dec
Jul
Apr

15,
02,
02,
09,
17,

2018

2019

2019

2021

2030

DS

DS DP U-1171

DS DP U-1171

DS DP U-1171

DP

I-714
NCE

Sep 03, 2018

Jul 20, 2016

TICAGRELOR - BRILINTA

N 022433 002 6251910

6525060

7250419

7265124

8425934

Jul
Dec
Dec
Jul
Apr

15,
02,
02,
09,
17,

2018

2019

2019

2021

2030

DS

DS DP U-1171

DS DP U-1171

DS DP U-1171

DP

NCE
NS

Jul 20, 2016

Sep 03, 2018

TIGECYCLINE - TYGACIL

N 021821 001 7879828

8372995

8975242

RE40183

Feb
Oct
Oct
Apr

05,
08,
24,
09,

2029

2030

2028

2016

DP

DP

DP

DS DP

TIMOLOL MALEATE - TIMOLOL MALEATE

N 020963 001 6174524
Mar 26, 2019

DP

TIMOLOL MALEATE - TIMOLOL MALEATE

N 020963 002 6174524

Mar 26, 2019

DP

TIMOLOL MALEATE - ISTALOL

N 021516 001 6335335

6645963

Nov 02, 2018

Nov 16, 2018

DP

DP

TIOTROPIUM BROMIDE - SPIRIVA

N 021395 001 6777423

6908928

6908928

7070800

7309707

7642268

7694676

8022082

RE38912

RE39820

Sep
Sep
Sep
Jan
Sep
Sep
Mar
Jan
Oct
Jan

NP

Sep 24, 2017

24,
24,
24,
22,
24,
24,
12,
19,
11,
30,

TIOTROPIUM BROMIDE - SPIRIVA RESPIMAT

N 021936 001 5964416
Oct 04,
6149054
Dec 16,
6176442
May 31,
6453795
Dec 05,
6726124
Oct 04,
6846413
Aug 28,
6977042
Aug 28,
6988496
Feb 23,
7104470
Oct 04,
7246615
May 31,
7284474
Aug 26,
7396341
Oct 10,
7802568
Feb 26,
7837235
Mar 13,
7896264
May 26,
7988001
Aug 04,
8733341
Dec 16,
9027967
Mar 31,
RE39820
Jan 30,

2021

2021

2021

2022

2021

2021

2027

2026

2021

2018

DS DP

DS DP U-566

DS DP U-762

DP U-566

DS DP

DS DP

DP

DP U-1186

DP

DS DP U-566

2016
2016
2016
2016
2016
2018
2018
2020
2016
2016
2024
2026
2019
2028
2025
2021
2029
2027
2018

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DP

DS DP U-1593

ADA 212 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
TIOTROPIUM BROMIDE - SPIRIVA RESPIMAT
N 021936 001 5964416
Oct 04, 2016
6149054
Dec 16, 2016
6176442
May 31, 2016
6453795
Dec 05, 2016
6726124
Oct 04, 2016
6846413
Aug 28, 2018
6977042
Aug 28, 2018
6988496
Feb 23, 2020
7104470
Oct 04, 2016
7246615
May 31, 2016
7284474
Aug 26, 2024
7396341
Oct 10, 2026
7802568
Feb 26, 2019
7837235
Mar 13, 2028
7896264
May 26, 2025
7988001
Aug 04, 2021
8733341
Dec 16, 2029
9027967
Mar 31, 2027
RE39820
Jan 30, 2018

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DS DP U-1593

NP

Sep 24, 2017

TIOTROPIUM BROMIDE - SPIRIVA RESPIMAT

N 021936 002 5964416
Oct 04,
6149054
Dec 16,
6176442
May 31,
6453795
Dec 05,
6726124
Oct 04,
6846413
Aug 28,
6977042
Aug 28,
6988496
Feb 23,
7104470
Oct 04,
7246615
May 31,
7284474
Aug 26,
7396341
Oct 10,
7802568
Feb 26,
7837235
Mar 13,
7896264
May 26,
7988001
Aug 04,
8733341
Dec 16,
9027967
Mar 31,
RE39820
Jan 30,

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DS DP

NP

Sep 15, 2018

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - LONSURF

N 207981 001 5744475
Mar 28, 2016
6479500
Mar 16, 2020
7799783
Dec 16, 2026

DS DP U-1751
U-1751
U-1751

NCE

Sep 22, 2020

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - LONSURF

N 207981 002 5744475
Mar 28, 2016
6479500
Mar 16, 2020
7799783
Dec 16, 2026

DS DP U-1751
U-1751
U-1751

NCE

Sep 22, 2020

APPL/PROD
NO

PATENT NO

2016
2016
2016
2016
2016
2018
2018
2020
2016
2016
2024
2026
2019
2028
2025
2021
2029
2027
2018

PATENT
CODES

TIPRANAVIR - APTIVUS
N 021814 001 5852195
6147095
6231887

Jun 22, 2019

Oct 29, 2019
Jul 27, 2018

DS

TIPRANAVIR - APTIVUS
N 022292 001 5852195
6147095

Jun 22, 2019

Oct 29, 2019

DS

TIROFIBAN HYDROCHLORIDE - AGGRASTAT

N 020912 001 5733919
Oct
5965581
Oct
5972967
Oct
5978698
Oct
6136794
Jan
6770660
May

23,
23,
23,
08,
29,
01,

2016
2016
2016
2017
2019
2023

U-670
DP

U-670

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ADA 213 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020913 001 5733919
Oct 23, 2016
5965581
Oct 23, 2016
5972967
Oct 23, 2016
5978698
Oct 08, 2017
6136794
Jan 29, 2019
6770660
Jun 01, 2023
APPL/PROD
NO

PATENT NO

TIROFIBAN HYDROCHLORIDE - AGGRASTAT

N 020913 002 5733919
Oct
5965581
Oct
5972967
Oct
5978698
Oct
6136794
Jan
6770660
Jun

23,
23,
23,
08,
29,
01,

2016
2016
2016
2017
2019
2023

TIROFIBAN HYDROCHLORIDE - AGGRASTAT

N 020913 003 5733919
Oct
5965581
Oct
5972967
Oct
5978698
Oct
6136794
Jan
6770660
Jun

23,
23,
23,
08,
29,
01,

2016
2016
2016
2017
2019
2023

TOBRAMYCIN - TOBI PODHALER

N 201688 001 7097827
7368102
7442388
7516741
7559325
8069851
8349294
8715623

Apr
Dec
May
Jan
Oct
Sep
May
Dec

16,
19,
10,
11,
27,
24,
10,
19,

2016
2022
2020
2024
2025
2024
2020
2022

TOBRAMYCIN - BETHKIS
N 201820 001 6987094
7696178
7939502

Sep 22, 2022

Mar 17, 2023
Jun 14, 2022

TOFACITINIB CITRATE - XELJANZ

N 203214 001 6956041
6965027
7091208
7265221
7301023
RE41783

Dec
Mar
Dec
Dec
May
Dec

08,
25,
08,
08,
23,
08,

2020
2023
2020
2020
2022
2020

PATENT
CODES

DP
DP U-909
DP
DP
DP
DP
DP
DP U-909

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NP

Mar 22, 2016

M-135
NCE

Feb 21, 2017

Nov 06, 2017

DP
DP
U-1324

DP
DS
U-247
DS
DS
DS

TOLTERODINE TARTRATE - DETROL LA

N 021228 001 6630162
Nov 11, 2019
6770295
Aug 26, 2019
6911217
Nov 11, 2019
6911217*PED
May 11, 2020

DP U-544
DP U-544
DP U-544

TOLTERODINE TARTRATE - DETROL LA

N 021228 002 6630162
Nov 11, 2019
6770295
Aug 26, 2019
6911217
Nov 11, 2019
6911217*PED
May 11, 2020

DP U-544
DP U-544
DP U-544

TOLVAPTAN - SAMSCA
N 022275 001 5753677
8501730

May 19, 2020

Sep 01, 2026

DS

TOLVAPTAN - SAMSCA
N 022275 002 5753677
8501730

May 19, 2020

Sep 01, 2026

DS

TOLVAPTAN - SAMSCA
N 022275 003 5753677
8501730

May 19, 2020

Sep 01, 2026

DS

U-978

U-978

U-978

ADA 214 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD

NO

PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

TOLVAPTAN - SAMSCA

N 022275 003 5753677

8501730

May 19, 2020

Sep 01, 2026

TOPIRAMATE - TOPAMAX

N 020505 001 5998380

6503884

7018983

7498311

Oct
Oct
Oct
Oct

13,
13,
13,
13,

2015

2015

2015

2015

U-598

U-598

U-723

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TOPAMAX

N 020505 002 5998380

6503884

7018983

7498311

Oct
Oct
Oct
Oct

13,
13,
13,
13,

2015

2015

2015

2015

U-598

U-598

U-723

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TOPAMAX

N 020505 003 5998380

6503884

7018983

7498311

Oct
Oct
Oct
Oct

13,
13,
13,
13,

2015

2015

2015

2015

U-598

U-598

U-723

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TOPAMAX

N 020505 004 5998380

6503884

7018983

7498311

Oct
Oct
Oct
Oct

13,
13,
13,
13,

2015

2015

2015

2015

U-598

U-598

U-723

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TOPAMAX

N 020505 005 5998380

6503884

7018983

7498311

Oct
Oct
Oct
Oct

13,
13,
13,
13,

2015

2015

2015

2015

U-598

U-598

U-723

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TOPAMAX

N 020505 006 5998380

6503884

7018983

7498311

Oct
Oct
Oct
Oct

13,
13,
13,
13,

2015

2015

2015

2015

U-598

U-598

U-723

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TOPAMAX

N 020844 001 5998380

6503884

7018983

7125560

7498311

Oct
Oct
Oct
Mar
Oct

13,
13,
13,
01,
13,

2015

2015

2015

2019

2015

U-598

U-598

U-723

U-766

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TOPAMAX

N 020844 002 5998380

6503884

7018983

7125560

7498311

Oct
Oct
Oct
Mar
Oct

13,
13,
13,
01,
13,

2015

2015

2015

2019

2015

U-598

U-598

U-723

U-766

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TOPAMAX SPRINKLE

N 020844 003 5998380

6503884

7018983

7125560

7498311

Oct
Oct
Oct
Mar
Oct

13,
13,
13,
01,
13,

2015

2015

2015

2019

2015

U-598

U-598

U-723

U-766

U-955

NPP

Mar 28, 2017

TOPIRAMATE - TROKENDI XR

N 201635 001 8298576

8298580

8663683

8877248

8889191

8992989

Apr
Nov
Nov
Nov
Nov
Nov

04,
16,
16,
16,
16,
16,

2028

2027

2027

2027

2027

2027

U-978

DS

DP
DP
DP
DP

U-106

U-106

U-106

U-106

U-106

DP U-1675

ADA 215 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TOPIRAMATE - TROKENDI XR
N 201635 002 8298576
8298580
8663683
8877248
8889191
8992989

Apr
Nov
Nov
Nov
Nov
Nov

04,
16,
16,
16,
16,
16,

2028
2027
2027
2027
2027
2027

DP
DP
DP
DP

TOPIRAMATE - TROKENDI XR
N 201635 003 8298576
8298580
8663683
8877248
8889191
8992989

Apr
Nov
Nov
Nov
Nov
Nov

04,
16,
16,
16,
16,
16,

2028
2027
2027
2027
2027
2027

DP
DP
DP
DP

TOPIRAMATE - TROKENDI XR
N 201635 004 8298576
8298580
8663683
8877248
8889191
8992989

Apr
Nov
Nov
Nov
Nov
Nov

04,
16,
16,
16,
16,
16,

2028
2027
2027
2027
2027
2027

DP
DP
DP
DP

TOPIRAMATE - QUDEXY XR
N 205122 001 8652527
8889190
9101545

Mar 19, 2033

Mar 19, 2033
Mar 19, 2033

DP
DP
DP

TOPIRAMATE - QUDEXY XR
N 205122 002 8652527
8889190
9101545

Mar 19, 2033

Mar 19, 2033
Mar 19, 2033

DP
DP
DP

TOPIRAMATE - QUDEXY XR
N 205122 003 8652527
8889190
9101545

Mar 19, 2033

Mar 19, 2033
Mar 19, 2033

DP
DP
DP

TOPIRAMATE - QUDEXY XR
N 205122 004 8652527
8889190
9101545

Mar 19, 2033

Mar 19, 2033
Mar 19, 2033

DP
DP
DP

TOPIRAMATE - QUDEXY XR
N 205122 005 8652527
8889190
9101545

Mar 19, 2033

Mar 19, 2033
Mar 19, 2033

DP
DP
DP

TOPOTECAN HYDROCHLORIDE - HYCAMTIN

N 020981 001 8158645
Dec 10, 2024

DP

TOPOTECAN HYDROCHLORIDE - HYCAMTIN

N 020981 002 8158645
Dec 10, 2024

DP

TRABECTEDIN - YONDELIS
N 207953 001 8895557

Jan 07, 2028

DP

TRAMADOL HYDROCHLORIDE - ULTRAM

N 020281 001 6339105

Oct 12, 2019

U-435

TRAMADOL HYDROCHLORIDE - ULTRAM

N 020281 002 6339105

Oct 12, 2019

U-435

TRAMADOL HYDROCHLORIDE - RYBIX ODT

N 021693 001 6106861
Dec 05, 2017

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-106
U-106
U-106
U-106
U-106
DP U-1675

U-106
U-106
U-106
U-106
U-106
DP U-1675

U-106
U-106
U-106
U-106
U-106
DP U-1675

DP

NCE
ODE

Oct 23, 2020

Oct 23, 2022

ADA 216 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TRAMADOL HYDROCHLORIDE - RYZOLT

N 021745 001 6607748
7988998

Jun 29, 2020

Oct 27, 2023

DP
DP

TRAMADOL HYDROCHLORIDE - RYZOLT

N 021745 002 6607748
7988998

Jun 29, 2020

Oct 27, 2023

DP
DP

TRAMADOL HYDROCHLORIDE - RYZOLT

N 021745 003 6607748
7988998

Jun 29, 2020

Oct 27, 2023

DP
DP

TRAMADOL HYDROCHLORIDE - CONZIP

N 022370 001 7858118

Apr 11, 2022

DP U-1104

TRAMADOL HYDROCHLORIDE - CONZIP

N 022370 002 7858118

Apr 11, 2022

DP U-1104

TRAMADOL HYDROCHLORIDE - CONZIP

N 022370 003 7858118

Apr 11, 2022

DP U-1104

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST

N 204114 001 7378423
Sep 13, 2025
8580304
Jan 28, 2032
8703781
Oct 15, 2030
8835443
Sep 13, 2025
8835443
Sep 13, 2025
9155706
Jan 28, 2032

DS DP
DP
DS DP U-1712
U-1581
U-1582
DP

I-678
NCE
ODE
ODE

Jan
May
May
Jan

08,
29,
29,
08,

2017
2018
2020
2021

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST

N 204114 002 7378423
Sep 13, 2025
8580304
Jan 28, 2032
8703781
Oct 15, 2030
8835443
Sep 13, 2025
8835443
Sep 13, 2025

DS DP
DP
DS DP U-1712
U-1581
U-1582

I-678
NCE
ODE
ODE

Jan
May
May
Jan

08,
29,
29,
08,

2017
2018
2020
2021

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST

N 204114 003 7378423
Sep 13, 2025
8580304
Jan 28, 2032
8703781
Oct 15, 2030
8835443
Sep 13, 2025
8835443
Sep 13, 2025
9155706
Jan 28, 2032

DS DP
DP
DS DP U-1712
U-1581
U-1582
DP

I-678
NCE
ODE
ODE

Jan
May
May
Jan

08,
29,
29,
08,

2017
2018
2020
2021

NP

May 15, 2017

PATENT NO

TRANEXAMIC ACID - LYSTEDA

N 022430 001 7947739
8022106
8273795
8487005
8791160
8809394
8957113
9060939

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

2025
2025
2025
2025
2025
2025
2025
2025

DP

TRAVOPROST - TRAVATAN Z
N 021994 001 8268299
8323630
8388941

Oct 13, 2029

Sep 20, 2027
Sep 20, 2027

DP
DP
DP

TRAVOPROST - IZBA
N 204822 001 8178582
8722735
8754123
9144561

Oct
Oct
May
Mar

2029
2029
2029
2029

DP
DP
DP
DP

TRAZODONE HYDROCHLORIDE - DESYREL

N 018207 001 8133893
Mar 13, 2029

DS DP

04,
04,
04,
04,
04,
04,
04,
04,

10,
10,
19,
13,

DP
DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1182
U-1182
U-1182
U-1182
U-1182
U-1182

ADA 217 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TRAZODONE HYDROCHLORIDE - DESYREL

N 018207 002 8133893
Mar 13, 2029

DS DP

TRAZODONE HYDROCHLORIDE - DESYREL

N 018207 003 8133893
Mar 13, 2029

DS DP

TRAZODONE HYDROCHLORIDE - DESYREL

N 018207 004 8133893
Mar 13, 2029

DS DP

TRAZODONE HYDROCHLORIDE - OLEPTRO

N 022411 001 6607748
Jun 29, 2020
7829120
Mar 27, 2027
8133893
Mar 13, 2029

DP
DP U-796
DS DP

TRAZODONE HYDROCHLORIDE - OLEPTRO

N 022411 002 6607748
Jun 29, 2020
7829120
Mar 27, 2027
8133893
Mar 13, 2029

DP
DP U-796
DS DP

TREPROSTINIL - REMODULIN
N 021272 001 6765117
7999007
8497393
8653137
8658694
9199908

Oct
Mar
Dec
Sep
Sep
May

24,
29,
15,
05,
05,
24,

2017
2029
2028
2028
2028
2024

DS

TREPROSTINIL - REMODULIN
N 021272 002 6765117
7999007
8497393
8653137
8658694
9199908

Oct
Mar
Dec
Sep
Sep
May

24,
29,
15,
05,
05,
24,

2017
2029
2028
2028
2028
2024

DS

TREPROSTINIL - REMODULIN
N 021272 003 6765117
7999007
8497393
8653137
8658694
9199908

Oct
Mar
Dec
Sep
Sep
May

24,
29,
15,
05,
05,
24,

2017
2029
2028
2028
2028
2024

DS

TREPROSTINIL - REMODULIN
N 021272 004 6765117
7999007
8497393
8653137
8658694
9199908

Oct
Mar
Dec
Sep
Sep
May

24,
29,
15,
05,
05,
24,

2017
2029
2028
2028
2028
2024

DS

TREPROSTINIL - TYVASO
N 022387 001 6521212
6756033
6765117
8497393

Nov
Nov
Oct
Dec

13,
13,
24,
15,

2018
2018
2017
2028

TREPROSTINIL DIOLAMINE - ORENITRAM

N 203496 001 6765117
Oct
7417070
Jul
7544713
Jul
8252839
May
8349892
Jan
8410169
Feb
8497393
Dec
8747897
Oct
9050311
May

24,
30,
14,
24,
22,
13,
15,
08,
24,

2017
2026
2024
2024
2031
2030
2028
2029
2024

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP U-1437
DS
U-1437
U-1437
U-1771

DP U-1437
DS
U-1437
U-1437
U-1771

DP U-1437
DS
U-1437
U-1437
U-1771

DP U-1437
DS
U-1437
U-1437
U-1771

U-1018
U-1018

M-145
ODE

May 20, 2017

Jul 30, 2016

NDF

Dec 20, 2016

DS
DS

DS
DS
U-1475
DP
DP
DP
DS
DP
DS DP

ADA 218 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
TREPROSTINIL DIOLAMINE - ORENITRAM
N 203496 002 6765117
Oct 24, 2017
7417070
Jul 30, 2026
7544713
Jul 14, 2024
8252839
May 24, 2024
8349892
Jan 22, 2031
8410169
Feb 13, 2030
8497393
Dec 15, 2028
8747897
Oct 08, 2029
9050311
May 24, 2024
APPL/PROD
NO

PATENT NO

PATENT
CODES
DS
DS

TREPROSTINIL DIOLAMINE - ORENITRAM

N 203496 004 6765117
Oct
7417070
Jul
7544713
Jul
8252839
May
8349892
Jan
8410169
Feb
8497393
Dec
8747897
Oct
9050311
May

24,
30,
14,
24,
22,
13,
15,
08,
24,

2017
2026
2024
2024
2031
2030
2028
2029
2024

DS
DS

NDF

Dec 20, 2016

DS
DP
DS DP

U-1475
DP
DP
DP
DS
DP
DS DP

DP U-134

TRETINOIN - RETIN-A MICRO

N 020475 002 5955109

Sep 21, 2016

U-134

TRETINOIN - RETIN-A-MICRO
N 020475 003 5955109

Sep 21, 2016

DP U-134

TRETINOIN - RENOVA
N 021108 001 6531141

Mar 07, 2020

TRIAMCINOLONE ACETONIDE - NASACORT ALLERGY 24 HOUR

N 020468 002 5976573
Jul 03, 2016
6143329
Jul 03, 2016
7977045
Jul 03, 2016

DP
DP
DP

TRIAMCINOLONE ACETONIDE - TRIESENCE

N 022048 001 6395294
Jan
8128960
Dec
8211880
Mar
8211880
Mar

DP U-846
DP
U-1257
U-1258

Jul 07, 2015

Dec 20, 2016

U-1475

Sep 21, 2016

TRIPTORELIN PAMOATE - TRELSTAR

N 020715 001 5776885

NDF

DP
DP
DP

TRETINOIN - RETIN-A MICRO

N 020475 001 5955109

TRIMETREXATE GLUCURONATE - NEUTREXIN

N 020326 002 6017922
May 18, 2018

Dec 20, 2016

DP
DS DP

DS
DS

TRIMETREXATE GLUCURONATE - NEUTREXIN

N 020326 001 6017922
May 18, 2018

NDF

DS

2017
2026
2024
2024
2031
2030
2028
2029
2024

TRIMETHOPRIM HYDROCHLORIDE - PRIMSOL

N 074973 001 5763449
Aug 07, 2016
5962461
Aug 07, 2016

EXCLUSIVITY
EXPIRATION
DATE

U-1475

24,
30,
14,
24,
22,
13,
15,
08,
24,

2020
2029
2029
2029

EXCLUSIVITY
CODE(S)

DP
DP
DP

TREPROSTINIL DIOLAMINE - ORENITRAM

N 203496 003 6765117
Oct
7417070
Jul
7544713
Jul
8252839
May
8349892
Jan
8410169
Feb
8497393
Dec
8747897
Oct
9050311
May

13,
17,
10,
10,

PATENT
DELIST
REQUESTED

ADA 219 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TRIPTORELIN PAMOATE - TRELSTAR

N 021288 001 5776885

Jul 07, 2015

DP

TRIPTORELIN PAMOATE - TRELSTAR

N 022437 001 5776885

Jul 07, 2015

DP

TROGLITAZONE - PRELAY
N 020719 001 5859037
6011049

Nov 13, 2017

Nov 13, 2017

U-251
U-301

TROGLITAZONE - PRELAY
N 020719 002 5859037
6011049

Nov 13, 2017

Nov 13, 2017

U-251
U-301

TROGLITAZONE - PRELAY
N 020719 003 5859037
6011049

Nov 13, 2017

Nov 13, 2017

U-251
U-301

TROGLITAZONE - REZULIN
N 020720 001 5859037
6011049

Nov 13, 2017

Nov 13, 2017

U-251
U-301

TROGLITAZONE - REZULIN
N 020720 002 5859037
6011049

Nov 13, 2017

Nov 13, 2017

U-251
U-301

TROGLITAZONE - REZULIN
N 020720 003 5859037
6011049

Nov 13, 2017

Nov 13, 2017

U-251
U-301

TROSPIUM CHLORIDE - SANCTURA XR

N 022103 001 7410978
7759359
7763635
7781448
7781449

Feb
Nov
Nov
Nov
Nov

TROVAFLOXACIN MESYLATE - TROVAN

N 020759 001 6187341

Jan 20, 2019

TROVAFLOXACIN MESYLATE - TROVAN

N 020759 002 6187341

Jan 20, 2019

PATENT NO

01,
04,
04,
04,
04,

2025
2024
2024
2024
2024

12,
02,
20,
12,

2030
2030
2029
2030

UMECLIDINIUM BROMIDE - INCRUSE ELLIPTA

N 205382 001 5873360
Feb 23,
7488827
Apr 27,
7498440
Apr 27,
8113199
Oct 23,
8161968
Feb 05,
8183257
Jul 27,
8201556
Feb 05,
8309572
Apr 27,
8534281
Aug 10,
8746242
Oct 11,

2016
2025
2025
2027
2028
2025
2029
2025
2029
2030

UMECLIDINIUM BROMIDE; VILANTEROL

N 203975 001 5873360
7439393
7488827
7498440
7776895
8113199

Jun
Jun
Feb
Jun

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
U-1071
U-1071
U-1071
U-1071

TRYPAN BLUE - MEMBRANEBLUE

N 022278 001
ULIPRISTAL ACETATE - ELLA
N 022474 001 8426392
8512745
8735380
8962603

PATENT
DELIST
REQUESTED

U-1389

ODE

Feb 20, 2016

NCE

Aug 13, 2015

NP

Dec 18, 2016

DP
DP
U-1657

DP
DS DP
DS DP
DP
DP
U-1476
DP
U-1476
DP
DP

TRIFENATATE - ANORO ELLIPTA

Feb 23, 2016
DP
Sep 11, 2022
DS DP U-1476
Apr 27, 2025
DS DP
Apr 27, 2025
DS DP
Sep 11, 2022
DP
Oct 23, 2027
DP

ADA 220 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
PATENT
DATE
CODES
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - ANORO ELLIPTA
N 203975 001 8161968
Feb 05, 2028
DP
8183257
Jul 27, 2025
U-1476
8309572
Apr 27, 2025
U-1476
8511304
Jun 14, 2027
DP U-1476
8534281
Aug 10, 2029
DP
8746242
Oct 11, 2030
DP
RE44874
Mar 23, 2023
DS DP U-1476
APPL/PROD
NO

PATENT NO

UNOPROSTONE ISOPROPYL - RESCULA

N 021214 001 6458836
6458836
6770675

Jul 09, 2021

Jul 09, 2021
Nov 24, 2018

U-333
U-1315
DP U-1322

URIDINE TRIACETATE - VISTOGARD

N 208159 001 5968914
6258795
7776838

Oct 19, 2016

Jul 10, 2018
Aug 17, 2027

DP

URIDINE TRIACETATE - XURIDEN

N 208169 001 6258795

Jul 10, 2018

DP

U-1791

VALACYCLOVIR HYDROCHLORIDE - VALTREX

N 020487 001 5879706
Jan 19, 2016
5879706
Jan 19, 2016
6107302
Jan 19, 2016
6107302
Jan 19, 2016

DP U-530
DP U-894
DS
U-530
DS
U-894

VALACYCLOVIR HYDROCHLORIDE - VALTREX

N 020487 002 5879706
Jan 19, 2016
5879706
Jan 19, 2016
6107302
Jan 19, 2016
6107302
Jan 19, 2016

DP U-530
DP U-894
DS
U-530
DS
U-894

VALGANCICLOVIR HYDROCHLORIDE - VALCYTE

N 021304 001

VALGANCICLOVIR HYDROCHLORIDE - VALCYTE

N 022257 001 6083953*PED
Sep 29, 2015

VALSARTAN - DIOVAN
N 021283 001 5972990
6294197

Oct 26, 2016

Jun 18, 2017

U-692
U-3

VALSARTAN - DIOVAN
N 021283 002 5972990
6294197

Oct 26, 2016

Jun 18, 2017

U-692
U-3

VALSARTAN - DIOVAN
N 021283 003 5972990
6294197

Oct 26, 2016

Jun 18, 2017

U-692
U-3

VALSARTAN - DIOVAN
N 021283 004 5972990
6294197

Oct 26, 2016

Jun 18, 2017

U-692
U-3

VANDETANIB - CAPRELSA
N 022405 001 7173038
8067427
8642608
RE42353

Aug
Aug
Feb
Sep

2021
2028
2022
2017

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE
NP

Sep 04, 2020

Dec 11, 2018

NCE
ODE

Sep 04, 2020

Sep 04, 2022

D-139

Feb 19, 2017

D-148
NPP

Apr 23, 2018

Apr 23, 2018

D-148
NPP

Apr 23, 2018

Apr 23, 2018

NCE
ODE

Apr 06, 2016

Apr 06, 2018

U-1791

UROFOLLITROPIN - BRAVELLE
N 021289 001

14,
08,
06,
23,

PATENT
DELIST
REQUESTED

DS DP
DP
U-1490
DS DP

ADA 221 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

VANDETANIB - CAPRELSA
N 022405 002 7173038
8067427
8642608
RE42353

PATENT
EXPIRATION
DATE

PATENT
CODES

Aug
Aug
Feb
Sep

14,
08,
06,
23,

2021
2028
2022
2017

DS DP
DP

VARDENAFIL HYDROCHLORIDE - LEVITRA

N 021400 001 6362178
Oct
7696206
Oct
8273876
Jul
8841446
Jul

31,
31,
23,
03,

2018
2018
2027
2023

DS DP U-533
DS DP U-533
U-1288
DP

VARDENAFIL HYDROCHLORIDE - LEVITRA

N 021400 002 6362178
Oct
7696206
Oct
8273876
Jul
8841446
Jul

31,
31,
23,
03,

2018
2018
2027
2023

DS DP U-533
DS DP U-533
U-1288
DP

VARDENAFIL HYDROCHLORIDE - LEVITRA

N 021400 003 6362178
Oct
7696206
Oct
8273876
Jul
8841446
Jul

31,
31,
23,
03,

2018
2018
2027
2023

DS DP U-533
DS DP U-533
U-1288
DP

VARDENAFIL HYDROCHLORIDE - LEVITRA

N 021400 004 6362178
Oct
7696206
Oct
8273876
Jul
8841446
Jul

31,
31,
23,
03,

2018
2018
2027
2023

DS DP U-533
DS DP U-533
U-1288
DP

VARDENAFIL HYDROCHLORIDE - STAXYN

N 200179 001 6362178
Oct 31, 2018
7696206
Oct 31, 2018
8613950
Dec 23, 2028

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE
ODE

Apr 06, 2016

Apr 06, 2018

U-1490
DS DP

U-155
U-155
DP

VARENICLINE TARTRATE - CHANTIX

N 021928 001 6410550
6890927
7265119

May 10, 2020

May 06, 2022
Aug 03, 2022

DS DP U-56
DS DP U-56
DS DP U-56

M-143
M-144

Oct 15, 2017

Oct 15, 2017

VARENICLINE TARTRATE - CHANTIX

N 021928 002 6410550
6890927
7265119

May 10, 2020

May 06, 2022
Aug 03, 2022

DS DP U-56
DS DP U-56
DS DP U-56

M-143
M-144

Oct 15, 2017

Oct 15, 2017

VELAGLUCERASE ALFA - VPRIV

N 022575 001

M-130

Nov 21, 2016

VELAGLUCERASE ALFA - VPRIV

N 022575 002

M-130

Nov 21, 2016

NCE
ODE

Aug 17, 2016

Aug 17, 2018

VEMURAFENIB - ZELBORAF
N 202429 001 7504509
7863288
8143271
8470818
8741920

Oct
Jun
Jun
Aug
Jul

22,
20,
21,
02,
27,

2026
2029
2026
2026
2030

DS DP
DS DP
DS DP

VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR

N 020699 001 6274171
Mar 20,
6403120
Mar 20,
6403120
Mar 20,
6419958
Mar 20,
6419958
Mar 20,

2017
2017
2017
2017
2017

U-451
U-535
U-459
U-535

VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR

N 020699 002 6274171
Mar 20,
6403120
Mar 20,
6403120
Mar 20,
6419958
Mar 20,

2017
2017
2017
2017

U-451
U-535
U-459

U-1418
DS DP

ADA 222 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 002 6419958
Mar 20, 2017
APPL/PROD
NO

PATENT NO

PATENT
CODES

2017
2017
2017
2017
2017

U-451
U-535
U-459
U-535

VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR

N 020699 004 6274171
Mar 20,
6403120
Mar 20,
6403120
Mar 20,
6419958
Mar 20,
6419958
Mar 20,

2017
2017
2017
2017
2017

U-451
U-535
U-459
U-535

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE

N 022104 001 6403120
Mar 20, 2017
6403120
Mar 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017

U-535
U-839
U-535
U-839

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE

N 022104 002 6403120
Mar 20, 2017
6403120
Mar 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017

U-535
U-839
U-535
U-839

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE

N 022104 003 6403120
Mar 20, 2017
6403120
Mar 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017

U-535
U-839
U-535
U-839

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE

N 022104 004 6403120
Mar 20, 2017
6403120
Mar 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017

U-535
U-839
U-535
U-839

VERAPAMIL HYDROCHLORIDE - COVERA-HS

N 020552 001 6096339
Apr 04, 2017

U-365

VERAPAMIL HYDROCHLORIDE - COVERA-HS

N 020552 002 6096339
Apr 04, 2017

U-365

VERTEPORFIN - VISUDYNE
N 021119 001 5707608
5756541
5798349

U-357
U-357

VIGABATRIN - SABRIL
N 020427 001

VIGABATRIN - SABRIL
N 022006 001

VILAZODONE HYDROCHLORIDE - VIIBRYD

N 022567 001 5532241
Sep
7834020
Jun
8193195
Jun
8236804
Jun
8673921
Jun

29,
05,
05,
05,
05,

2019
2022
2022
2022
2022

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-535

VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR

N 020699 003 6274171
Mar 20,
6403120
Mar 20,
6403120
Mar 20,
6419958
Mar 20,
6419958
Mar 20,

Aug 02, 2015

Mar 11, 2016
Aug 25, 2015

PATENT
DELIST
REQUESTED

DS DP
DS DP U-839
U-839
U-839
DS DP

NPP
PED

Oct 26, 2016

Apr 26, 2017

NPP
ODE
PED
PED

Oct
Aug
Feb
Apr

D-146
NCE

Mar 16, 2018

Jan 21, 2016

26,
21,
21,
26,

2016
2016
2017
2017

ADA 223 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
VILAZODONE HYDROCHLORIDE - VIIBRYD
N 022567 002 5532241
Sep 29, 2019
7834020
Jun 05, 2022
8193195
Jun 05, 2022
8236804
Jun 05, 2022
8673921
Jun 05, 2022

DS DP
DS DP U-839
U-839
U-839
DS DP

D-146
NCE

Mar 16, 2018

Jan 21, 2016

VILAZODONE HYDROCHLORIDE - VIIBRYD

N 022567 003 5532241
Sep
7834020
Jun
8193195
Jun
8236804
Jun
8673921
Jun

DS DP
DS DP U-839
U-839
U-839
DS DP

D-146
NCE

Mar 16, 2018

Jan 21, 2016

NP
ODE

Aug 09, 2015

Aug 09, 2019

APPL/PROD
NO

PATENT NO

29,
05,
05,
05,
05,

2019
2022
2022
2022
2022

PATENT
CODES

VINCRISTINE SULFATE - MARQIBO KIT

N 202497 001 6723338
Mar 31, 2020
7247316
Sep 25, 2020
7887836
Mar 31, 2020

U-1271
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1271

VISMODEGIB - ERIVEDGE
N 203388 001 7888364

Nov 11, 2028

DS DP

NCE

Jan 30, 2017

VORAPAXAR SULFATE - ZONTIVITY

N 204886 001 7235567
7304078

Jun 13, 2021

Apr 06, 2024

DS DP
DS DP U-1512

NCE

May 08, 2019

VORICONAZOLE - VFEND
N 021266 001 5567817

May 24, 2016

DS DP U-540

VORICONAZOLE - VFEND
N 021266 002 5567817

May 24, 2016

DS DP U-540

VORICONAZOLE - VFEND
N 021267 001 5567817
6632803

May 24, 2016

Jun 02, 2018

DS DP U-540
DP

VORICONAZOLE - VFEND
N 021630 001 5567817

May 24, 2016

DS DP U-540

VORINOSTAT - ZOLINZA
N 021991 001 7399787
7456219
7652069
7732490
7851509
8067472
8093295
8101663
8450372
RE38506

Feb
Mar
Mar
Mar
Feb
Mar
May
Mar
Mar
Jul

09,
11,
04,
04,
21,
04,
16,
04,
18,
07,

2025
2027
2023
2023
2024
2023
2026
2023
2028
2015

U-892

VORTIOXETINE HYDROBROMIDE - BRINTELLIX

N 204447 001 7144884
Jan 09,
8476279
Oct 02,
8722684
Jun 30,
8969355
Jun 15,

2023
2022
2031
2027

DS DP U-1439
DP U-1439
DS DP
U-1668

NCE

Sep 30, 2018

VORTIOXETINE HYDROBROMIDE - BRINTELLIX

N 204447 002 7144884
Jan 09,
8476279
Oct 02,
8722684
Jun 30,
8969355
Jun 15,

2023
2022
2031
2027

DS DP U-1439
DP U-1439
DS DP
U-1668

NCE

Sep 30, 2018

VORTIOXETINE HYDROBROMIDE - BRINTELLIX

N 204447 003 7144884
Jan 09,
8476279
Oct 02,
8722684
Jun 30,
8969355
Jun 15,

2023
2022
2031
2027

DS DP U-1439
DP U-1439
DS DP
U-1668

NCE

Sep 30, 2018

DS
DP
U-892
DP U-892
U-892
DP
U-892
U-892
DS DP

ADA 224 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT
EXPIRATION
DATE
VORTIOXETINE HYDROBROMIDE - BRINTELLIX

N 204447 004 7144884
Jan 09, 2023

8476279
Oct 02, 2022

8722684
Jun 30, 2031

8969355
Jun 15, 2027

PATENT NO

PATENT
CODES
DS DP U-1439
DP U-1439

DS DP

U-1668

ZICONOTIDE ACETATE - PRIALT

N 021060 001 5364842
5364842
8653033
8653033
8765680
8765680

Dec
Dec
Oct
Oct
Oct
Oct

30,
30,
01,
01,
01,
01,

2016

2016

2024

2024

2024

2024

U-48

U-55

U-48

U-55

U-48

U-55

ZICONOTIDE ACETATE - PRIALT

N 021060 002 5364842
5364842
8653033
8653033
8765680
8765680

Dec
Dec
Oct
Oct
Oct
Oct

30,
30,
01,
01,
01,
01,

2016

2016

2024

2024

2024

2024

U-48

U-55

U-48

U-55

U-48

U-55

ZICONOTIDE ACETATE - PRIALT

N 021060 003 5364842
5364842
8653033
8653033
8765680
8765680

Dec
Dec
Oct
Oct
Oct
Oct

30,
30,
01,
01,
01,
01,

2016

2016

2024

2024

2024

2024

U-48

U-55

U-48

U-55

U-48

U-55

ZICONOTIDE ACETATE - PRIALT

N 021060 004 5364842
5364842
8653033
8653033
8765680
8765680

Dec
Dec
Oct
Oct
Oct
Oct

30,
30,
01,
01,
01,
01,

2016

2016

2024

2024

2024

2024

U-48

U-55

U-48

U-55

U-48

U-55

ZIPRASIDONE HYDROCHLORIDE - GEODON

N 020825 001 6150366
May 27, 2019

6245766
Dec 18, 2018

DP

ZIPRASIDONE HYDROCHLORIDE - GEODON

N 020825 002 6150366
May 27, 2019

6245766
Dec 18, 2018

DP

ZIPRASIDONE HYDROCHLORIDE - GEODON

N 020825 003 6150366
May 27, 2019

6245766
Dec 18, 2018

DP

ZIPRASIDONE HYDROCHLORIDE - GEODON

N 020825 004 6150366
May 27, 2019

6245766
Dec 18, 2018

DP

ZIPRASIDONE HYDROCHLORIDE - GEODON

N 021483 001 6150366
May 27, 2019

6245766
Dec 18, 2018

7175855
May 18, 2020

ZIPRASIDONE MESYLATE - GEODON

N 020919 001 6110918
6232304
6399777

Mar 26, 2017

Apr 01, 2017

Apr 01, 2017

ZOLEDRONIC ACID - ZOMETA

N 021223 002 8324189
8324189
8324189

May 29, 2025

May 29, 2025

May 29, 2025

U-601

U-601

U-601

U-601

DP U-719

U-601

DP

U-53

U-1308

U-1309

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)
NCE

EXCLUSIVITY

EXPIRATION

DATE

Sep 30, 2018

ADA 225 of 225

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ZOLEDRONIC ACID - ZOMETA

N 021223 003 7932241
8324189
8324189
8324189

Feb
May
May
May

2028
2025
2025
2025

DP

ZOLEDRONIC ACID - RECLAST

N 021817 001 7932241
8052987

Feb 05, 2028

Oct 27, 2023

DP

ZOLMITRIPTAN - ZOMIG
N 021450 003 6750237
6750237*PED
7220767
7220767*PED

Nov
May
Nov
May

2020
2021
2020
2021

DP

ZOLMITRIPTAN - ZOMIG
N 021450 004 6750237
7220767

Nov 28, 2020

Nov 28, 2020

DP
DP

ZOLPIDEM TARTRATE - AMBIEN CR

N 021774 001 6514531

Dec 01, 2019

DP

ZOLPIDEM TARTRATE - AMBIEN CR

N 021774 002 6514531

Dec 01, 2019

DP

ZOLPIDEM TARTRATE - EDLUAR

N 021997 001 6761910
8512747

Sep 24, 2019

Sep 24, 2019

DP U-674
U-674

ZOLPIDEM TARTRATE - EDLUAR

N 021997 002 6761910
8512747

Sep 24, 2019

Sep 24, 2019

DP U-674
U-674

ZOLPIDEM TARTRATE - ZOLPIMIST

N 022196 001 7632517

Oct 01, 2017

ZOLPIDEM TARTRATE - INTERMEZZO

N 022328 001 7658945
7682628
8242131
8252809

Apr
Feb
Aug
Feb

15,
16,
20,
16,

2027
2025
2029
2025

DP U-1194
U-1194
U-1266
DP

ZOLPIDEM TARTRATE - INTERMEZZO

N 022328 002 7658945
7682628
8242131
8252809

Apr
Feb
Aug
Feb

15,
16,
20,
16,

2027
2025
2029
2025

DP U-1194
U-1194
U-1266
DP

05,
29,
29,
29,

28,
28,
28,
28,

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-53
U-1308
U-1309

U-1199

NPP

Jun 12, 2018

NPP

Jun 12, 2018

DP

U-70

Footnote:
1. Patents are published upon receipt by the Orange book Staff and may not reflect the official receipt

date as described in 21 CFR 314.53(d)(5).

2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and

submitted by the sponsor. They may not be flagged with respect to other claims which may apply.

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 1 of 73

PATENT & EXCLUSIVITY ABBREVIATIONS

D
GAIN
I
M
NC
NCE
NCE*
NDF
NE
NP
NP*
NPP
NR
NS
ODE
PC
PED
RTO
RTO*
RTO**
U
W

NEW DOSING SCHEDULE (SEE INDIVIDUAL REFERENCES)

GAIN EXCLUSIVITY
NEW INDICATION (SEE INDIVIDUAL REFERENCES)
MISCELLANEOUS EXCLUSIVITY CODES (SEE INDIVIDUAL REFERENCES)
NEW COMBINATION
NEW CHEMICAL ENTITY
NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE
SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
NEW DOSAGE FORM
NEW ESTER OR SALT OF AN ACTIVE INGREDIENT
NEW PRODUCT
NEW PRODUCT (MINT FLAVORED)
NEW PATIENT POPULATION
NEW ROUTE
NEW STRENGTH
ORPHAN DRUG EXCLUSIVITY
PATENT CHALLENGE
PEDIATRIC EXCLUSIVITY
RX TO OTC SWITCH OR OTC USE
OTC USE FOR WOMEN AGES 15 AND 16
OTC USE FOR WOMEN 14 AND BELOW
PATENT USE CODE
EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR
- SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY

EXCLUSIVITY DOSING SCHEDULE

D-1
D-2
D-3
D-4
D-5
D-6
D-7
D-8
D-9
D-10
D-11
D-12
D-13
D-14
D-15
D-16
D-17
D-18
D-19
D-20
D-21
D-22
D-23
D-24
D-25
D-26
D-27
D-28
D-29
D-30
D-31
D-32
D-33

ONCE A DAY APPLICATION

ONCE DAILY DOSING
SEVEN DAYS/SEVEN DAYS/SEVEN DAYS DOSING SCHEDULE
SEVEN DAYS/FOURTEEN DAYS DOSING SCHEDULE
TEN DAYS/ELEVEN DAYS DOSING SCHEDULE
SEVEN DAYS/NINE DAYS/FIVE DAYS DOSING SCHEDULE
BID DOSING
INTRAVENOUS, EPIDURAL AND INTRATHECAL DOSING
NARCOTIC OVERDOSE IN ADULTS
NARCOTIC OVERDOSE IN CHILDREN
POSTOPERATIVE NARCOTIC DEPRESSION IN CHILDREN
BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE DUODENAL ULCER
INCREASED MAXIMUM DAILY DOSAGE RECOMMENDATION
BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
SINGLE DAILY DOSE OF 25MG/37.5MG
CONTINUOUS INTRAVENOUS INFUSION
400MG EVERY 12 HOURS FOR THREE DAYS FOR UNCOMPLICATED URINARY TRACT INFECTIONS
LOWER RECOMMENDED STARTING DOSE GUIDELINES
BOLUS DOSING GUIDELINES
SINGLE 32MG DOSE
ALTERNATIVE DOSAGE OF 300MG ONCE DAILY AFTER THE EVENING MEAL
REDUCTION IN INFUSION TIME FROM 24 TO 4 HOURS FOR THE 60MG DOSE
INCREASE MAXIMUM DOSE AND VARIATIONS IN THE DOSING REGIMEN
FOR OVARIAN CANCER THE RECOMMENDED REGIMEN IS 135MG/M2 OR 175MG/M2 INTRAVENOUSLY
OVER THREE HOURS EVERY THREE WEEKS
ADDITIONAL DOSAGE REGIMEN EQUAL TO HALF THE ORIGINAL DOSING REGIMEN
ONCE WEEKLY APPLICATION
BID DOSING IN PATIENTS 12 YEARS OF AGE AND OLDER FOR PREVENTION OF NAUSEA AND
VOMITING ASSOCIATED WITH MODERATE EMETOGENIC CANCER CHEMOTHERAPY
USE OF ISOVUE-370 IN EXCRETORY UROGRAPHY AT EQUIVALENT GRAMS OF IODINE TO THE
CURRENTLY APPROVED ISOVUE-250 AND ISOVUE-300
INCREASE OF CUMULATIVE DOSE TO 0.3MMOL/KG FOR MRI OF CNS IN ADULTS
5000 IU DOSE FOR PHOPHYLAXIX AGAINST DEEP VEIN THROMBOSIS
CHANGE IN RECOMMENDED TOTAL DAILY DOSE TO 80MG (40MG BID)
REMOVAL OF THE RESTRICTIONS LIMITING TREATMENT TO TWO CONSECUTIVE WEEKS AND TO
SMALL AREAS
ONCE DAILY DOSING FOR PLAQUE PSORIASIS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 2 of 73

EXCLUSIVITY DOSING SCHEDULE

D-34
D-35
D-36
D-37
D-38
D-39

D-40
D-41
D-42

D-43
D-44

D-45
D-46
D-47
D-48
D-49
D-50
D-51
D-52
D-53
D-54
D-55
D-56
D-57

D-58
D-59
D-60
D-61
D-62
D-63
D-64

D-65
D-66
D-67
D-68

D-69
D-70
D-71
D-72
D-73
D-74
D-75

EVERY FOUR MONTHS DOSAGE REGIMEN

FOR A ONE WEEK DOSING OF INTERDIGITAL TINEA PEDIS
FOR A SINGLE 2MG DOSE AS AN ALTERNATIVE TO THE 1MG DOSE GIVEN TWICE DAILY
DOSING REGIMEN FOR ADMINISTRATION EITHER ONCE DAILY (QD) OR TWICE DAILY (BID)
CONTINUOUS INFUSION AS AN ALTERNATE METHOD OF ADMINISTRATION
CHANGE IN TIME TO TAKE THE DRUG PRIOR TO A MEAL TO PREVENT MEAL-INDUCED HEARTBURN
SYMPTOMS FROM "..1/2 TO 1 HOUR BEFORE EATING" TO ".. RIGHT BEFORE EATING OR UP TO
60MIN BEFORE CONSUMING..."
ONCE-A-DAY DOSING REGIMEN
DRUG MAY BE DOSED RIGHT BEFORE A MEAL OR ANY TIME UP TO 30MIN BEFORE EATING OR
DRINKING FOOD AND BEVERAGES THAT WOULD BE EXPECTED TO CAUSE SYMPTOMS
TEN DAY DOSING REGIMEN FOR TRIPLE THERAPY, PREVACID IN COMBINATION WITH
CLARITHROMYCIN AND AMOXICILLIN, FOR THE ERADICATION OF H.PYLORI IN PATIENTS WITH
DUODENAL ULCER DISEASE
INITIATION OF TREATMENT WITH 900MG/DAY BY DELETION OF THE REQUIREMENT TO TITRATE
TO 900MG/DAY OVER A 3-DAY PERIOD
IN A CLINICAL TRIAL, FEWER DISCONTINUATIONS DUE TO ADVERSE EVENTS, ESPECIALLY
DIZZINESS AND VERTIGO, WERE OBSERVED WHEN TITRATING THE DOSE IN INCREMENTS OF
50MG/DAY EVERY 3 DAYS UNTIL AN EFFECTIVE DOSE (NOT EXCEEDING 400MG/DAY) WAS
REACHED
ONCE DAILY DOSING FOR MAINTENANCE ONLY
NEW DOSING REGIMEN OF 80MG DAILY
PREVENTION OF HEARTBURN SYMPTOMS WHEN ADMINISTERED FROM 15 MINUTES UP TO, BUT NOT
INCLUDING, 1 HOUR PRIOR TO A PROVOCATIVE MEAL
ADIMISTRATION OF CISATRICURIUM A NEUROMUSCULAR BLOCKING AGENT AT DOSES OF 3 AND 4X
THE ED95 OF CISATRICURIUM FOLLOWING INDUCTION WITH THIOPENTAL
PEDIATRIC DOSING GUIDELINES
INFORMATION FOR USE OF CORVERT IN POST-CARDIAC SURGERY PATIENTS
OPTIONAL STARTING DOSE OF 40MG/DAY
ALTERNATE DOSING REGIMEN OF 1250MG TWICE DAILY
USE IN PEDIATRIC PATIENTS FROM 1 MONTH TO 16 YEARS OF AGE
USE OF ZYBAN FOR MAINTENANCE THERAPY. TREATMENT UP TO 6 MONTHS WAS SHOWN
EFFICACIOUS
ADDITION OF A HIGHER DOSE OF NUTROPIN FOR PUBERTAL PATIENTS (PUBERTAL DOSE LESS
THAN OR EQUAL TO 0.7MG/KG/WEEK)
ADDITION OF POSTPRANDIAL DOSING
3-HOUR INFUSION OF TAXOL GIVEN EVERY THREE WEEKS AT A DOSE OF 175MG/M2 FOLLOWED BY
CISPLATIN AT A DOSE OF 75MG/M2 FOR THE FIRST-LINE TREATMENT OF ADVANCED OVARIAN
CANCER
CHANGE IN DOSING INTERVAL TO ONCE-DAILY ADMINISTRATION
REDUCTION OF ELEVATED LDL-C IN A NEW, HIGHER STRENGTH TABLET, 0.8MG, AND FOR
EXTENSION OF THE DOSAGE RANGE TO 0.8MG DAILY
ADDITION OF A POST-OPERATIVE DOSING REGIMEN
ONCE WEEKLY DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
ONCE WEEKLY DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
TO ALLOW A TITRATION DOSING REGIMEN USING A 25MG DOSE
INCREASING DOSAGE FOR NERVE BLOCK ANESTHESIA USING NAROPIN 7.5MG/ML AND FOR
EXTENDING THE DURATION OF TREATMENT FOR POSTOPERATIVE ANALGESIA USING NAROPIN
2MG/ML
CHANGE DOSING AND ADMINISTRATION TO INDICATE MAINTENANCE OF WEIGHT LOSS OVER AN 18
MONTH PERIOD THUS EXTENDING THE USE OF THIS DRUG FROM ONE TO TWO YEARS
DOSING RECOMMENDATIONS FOR PATIENTS UNDERGOING PCI
SHORTER TREATMENT COURSE OF THREE DAYS IN THE TREATMENT OF RECURRENT EPISODES OF
GENITAL HERPES
CHANGE OF ADMIN RATE FOR INFUSION OF AREDIA FOR TREATMENT OF MODERATE AND SEVERE
HYPERCALCEMIA OF MALIGNANCY FROM 24 HOURS TO 2 HOURS UP TO BUT NOT INCLUDING 24
HOURS
SHORTENED DOSING REGIMEN TO 5 DAYS FOR THE TREATMENT OF ACUTE EXACERBATION OF
CHRONIC BRONCHITIS
80MG ONCE DAILY DOSING REGIMEN
EIGHT WEEK DOSING REGIMEN
INFORMATION REGARDING INCREASED RATE OF INFUSION FOR DEPACON
ONCE A WEEK DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
ONCE A WEEK DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
INTERMITTENT DOSING REGIMEN, STARTING DAILY DOSE 14 DAYS PRIOR TO THE ANTICIPATED
ONSET OF MENSTRUATION THROUGH THE FIRST FULL DAY OF MENSES AND REPEATING WITH EACH

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 3 of 73

EXCLUSIVITY DOSING SCHEDULE

D-76
D-77
D-78
D-79

D-80
D-81
D-82
D-83
D-84

D-85
D-86
D-87
D-88
D-89
D-90
D-91
D-92
D-93
D-94
D-95
D-96
D-97

D-98
D-99
D-100
D-101
D-102
D-103

D-104
D-105
D-106

D-107

D-108
D-109

NEW CYCLE
FOR USE ON AN "AS NEEDED" OR PRN BASIS FOR THE MANAGEMENT OF NASAL SYMPTOMS IN
PATIENTS FOR WHOM THE DRUG IS INDICATED
ADDITION OF 20MG AND 40MG DAILY AS OPTIONAL STARTING DOSES WITH 40MG INTENDED FOR
PATIENTS WHO REQUIRE A LARGE REDUCTION IN LDL-C (MORE THAN 45%)
USE OF FLEXERIL 5MG FOR THE RELIEF OF MUSCLE SPASM ASSOCIATED WITH ACUTE, PAINFUL,
MUSCULOSKELETAL CONDITIONS
NEW LOWER STARTING DOSE FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS
AND/OR MODERATE TO SEVERE SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED W/ THE
MENOPAUSE
CHANGE OF DOSING SCHEDULE FOR LANTUS FROM ONCE DAILY AT BEDTIME TO FLEXIBLE DAILY
DOSING
NEW LOWER STARTING DOSE FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPORSIS
USE OF PREMARIN 0.3 MG AND 0.45 MG FOR THE PREVENTION OF POSTMENOPAUSAL
OSTEOPOROSIS
750 MG, ONCE DAILY FOR 5 DAYS FOR COMMUNITY ACQUIRED PNEUMONIA (CAP)
ONCE-A-DAY DOSING OF FLOXACIN OTIC FOR THE TREATMENT OF ADULTS AND PEDIATRIC
PATIENTS(AGES 6 MO & OLDER) W/ OTITIS EXTERNA CAUSED BY SUSCEPTIBLE STRAINS OF
E.COLI, P.AERUGINOSA AND S.AUREUS
LOWER RECOMMENDED STARTING DOSE GUIDELINES FOR TREATMENT OF MODERATE TO SEVERE
VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
FOR USE IN SELECT EXTERNAL INSULIN PUMPS
ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
NEW DOSING RANGE OF 200-400MG PER DAY IN TWO DIVIDED DOSES FOR ADULTS WITH PARTIAL
SEIZURES
USE OF REYATAZ 300 MG/RITONAVIR 100 MG ONCE DAILY FOR TREATMENT IN HIV-INFECTED
ANTIRETROVIRAL-EXPERIENCED PATIENTS
ADDITION OF DAYTIME ADMINISTRATION TO TREAT VULVOVAGINAL CANDIDIASIS
ALTERNATE INTERMITTENT DOSING REGIMEN
ALTERNATIVE DOSAGE OF 1000MG ONCE DAILY AT BEDTIME
ALTERNATE TWO OR THREE TIMES DAILY DOSING REGIMENS
NEW MAXIMUM DOSAGE OF 72 MG/DAY IN ADOLESCENTS 13-17 YEARS OF AGE WITH ATTENTION
DEFECIT HYPERACTIVITY DISORDER (ADHD)
BROADENED INITIAL STARTING DOSE FOR HYPERTENSION FROM 50 MG TO 100 MG TO 25 MG TO
100 MG DOSE RANGE
ONCE-MONTHLY TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS WITH BONIVA (IBANDRONATE
SODIUM) 150 MG TABLETS
PED CANCER PT POPULATION EXPANDED TO INCLUDE PTS 6 MOS UP TO BUT NOT INCLUDING 4
YRS AND DOSING INSTRUCTIONS TO ADMIN 30 MIN BEFPRE CHEMO WITH SECOND AND THIRD
DOSES 4 & 8 HOURS AFTER FIRST DOSE
DOSING FOR PED SURGICAL PTS EXPANDED TO INCLUDE PTS 1 MONTH UP TO BUT NOT
INCLUDING 2 YEARS OF AGE
ONCE DAILY ADMINISTRATION FOR THE TREATMENT OF HIV INFECTION IN THERAPY NAIVE
ADULT PATIENTS
750 MG ONCE DAILY FOR FIVE DAYS FOR THE TREATMENT OF ACUTE BACTERIAL SINUSITIS
ONCE DAILY IN CHRONIC IDIOPATHIC UTICARIA FOR ADULTS AND CHILDREN 12 YEARS OF AGE
AND OLDER
NEW DOSING REGIMEN OF ONE SPRAY TWICE DAILY FOR SEASONAL ALLERIC RHINITIS IN
PATIENTS 12 YRS OF AGE AND OLDER
NEW DOSING RECOMMENDATION FOR THE TREATMENT OF RECURRENT GENITAL HERPES IN
IMMUNOCOMPETENT PATIENTS, SPECIFICALLY A REDUCTION IN COURSE OF THERAPY FROM
FAMCICLOVIR 125 MG TWICE-A-DAY FOR 5 DAYS TO 1000 MG TWICE-A-DAY FOR 1 DAY.
0.5MG/0.1MG FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED
WITH MENOPAUSE IN WOMEN WHO HAVE A UTERUS
USE OF ACTONEL 75MG TWO CONSECUTIVE DAYS PER MONTH FOR THE PREVENTION AND
TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
FIVE DAY TREATMENT OF SELECTED SUSCEPTIBLE STRAINS OF STREPTOCOCCUS PNEUMONIAE,
HAEMOPHILUS INFLUENZA, MYCOPLASMA PNEUMONIAE, AND CHLAMYDIA PNEUMONIAE FOR
COMMUNITY-ACQUIRED PNEUMONIA
PROVIDES FOR THE COMBINATION TABLET OF 70MG ALENDRONATE AND 5600 IU OF VITAMIN D3
FOR THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND TO INCREASE BONE
MASS IN MEN WITH OSTEOPOROSIS
TREATMENT OF COMPLICATED URINARY TRACT INFECTION AND ACUTE PYELONEPHRITIS WITH
LEVAQUIN 750MG ONCE DAILY FOR FIVE DAYS
PROVIDE FOR THE USE OF A LOWER DOSE FOR THE TREATMENT OF ADULTS WITH CHRONIC PHASE
CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY
INCLUDING IMATINIB MESYLATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 4 of 73

EXCLUSIVITY DOSING SCHEDULE

D-110
D-111
D-112
D-113
D-114
D-115
D-116
D-117
D-118
D-119
D-120
D-121
D-122
D-123
D-124
D-125

D-126
D-127
D-128

D-129
D-130

D-131
D-132
D-133

D-134
D-135
D-136
D-137
D-138
D-139

D-140
D-141
D-142
D-143
D-144
D-145

D-146
D-147

TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGED 13-17

PROVIDES FOR ONCE DAILY USE OF CIALIS, 2.5 MG AND 5 MG, FOR THE TREAMTENT OF
ERECTILE DYSFUNCTION
PROVIDES FOR PEDIATRIC PUMP USE
ONCE DAILY DOSING REGIMEN FOR PATIENTS WHO BECOME CONSTIPATED ON TWICE DAILY
REGIMEN
NEW DOSING RECOMMENDATIONS FOR USE OF SIROLIMUS IN COMBINATION WITH CYCLOSPORINE
FOR THE PROPHYLAXIS OF REJECTION IN HIGH-RISK RENAL TRANSPLANT RECIPIENTS
STARTING DOSE OF 15MG/DAY FOR MONOTHERAPY IN ACUTE TREATMENT OF BIPOLAR DISORDER,
MANIC OR MIXED
ALTERNATIVE DOSING REGIMEN ATAZANAVIR SULATE CO-ADMINISTERED WITH RITONAVIR FOR
THE TREATMENT OF HIV-1 INFECTION IN TREATMENT NAIVE PATIENTS
50 MG TABLET FOR INITIATION OF DOSE TITRATION FOR BIPOLAR DISORDER
TWO 400MG TABLETS ONCE DAILY, CO-ADMINISTERED WITH 100MG RITONAVIR
DOSING RECOMMENDATIONS FOR HIV INFECTED PEDIATRIC PATIENTS 6 TO LESS THAN 18 YEARS
OF AGE
DOSING REGIMEN ADJUSTMENTS
CHANGE TO REMOVE 20 MG MAXIMUM DOSAGE RESTRICTION
USE OF VAGIFEM 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
ALTERNATIVE DOSING REGIMEN DOSE OF 20 MG/METER SQUARE BY CONTINUOUS INTRAVENOUS
INFUSION OVER 1 HOUR REPEATED DAILY FOR 5 DAYS
ONCE DAILY DOSING REGIMEN IN ADULT PATIENTS WITH LESS THAN THREE LOPINAVIR
RESISTANCE-ASSOCIATED SUBSTITUTIONS
EXTEND CURRENT DOSING REGIMEN TO 900MG (2-450MG TABLETS) ONCE A DAY WITHIN 10 DAYS
OF TRANSPLANTATION UNTIL 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF
CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT PATIENTS AT HIGH RISK.
CHANGE DOSAGE REGIMEN FROM 250MG TO 500MG
DOSING REGIMEN FOR ADULT PATIENTS WITH CHRONIC HEPATITIS B (CHB) AND DECOMPENSATED
LIVER DESEASE
SINGLE IV DOSE OF FOSAPREPITANT 150MG, DOSED CONCOMITANTLY WITH 5HT3 RECEPTOR
ANTAGONIST & CORTICOSTEROID, FOR PREVENTION OF ACUTE & DELAYED NAUSEA & VOMITING
ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMO
800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1
INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
DOSING RECOMMENDATIONS FOR TREATMENT OF HIV-1 INFECTION DURING PREGNANCY BASED ON
DATA FROM STUDY AI424-182, A STUDY OF ATAZANAVIR/RITONAVIR IN COMBINATION WITH
ZIDOVUDINE/LAMIVUDINE IN HIV INFECTED PREGNANT WOMEN
EVERY 6 TO 8 WEEKS FOR THE 120MG STRENGTH FOR PATIENTS WHO ARE CONTROLLED ON
SOMATULINE DEPOT 60MG OR 90MG
45MG FOR 6 MONTH ADMINISTRATION
NEW EFFICACY DATA AND DOSING REGIMEN FOR PREGNANCY IN NORMAL OVULATORY WOMEN
UNDERGOING CONTROLLED OVARIAN STIMULATION AS PART OF AN IVF OR INTRACYTOPLASMIC
SPERM INJECTION (ICSI) CYCLE
INCREASING MAXIMUM DOSING OF PATIENTS WITH SCHIZOPHRENIA TO 160 MG/DAY
UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE
PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE
ALTERNATE DOSING REGIMEN FOR UNCOMPLICATED URETHRAL OR ENDOCERVICAL INFECTION
CAUSED BY CHLAMYDIA TRACHOMATIS, ADMINISTER 200 MG BY MOUTH ONCE-A-DAY FOR 7 DAYS
NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL
HYPERTENSION (WHO GROUP 1) IN ADULTS
80 MG DOSING REGIMEN FOR THE RISK REDUCTION OF REBLEEDING OF GASTRIC AND DUODENAL
ULCERS IN THE FIRST 72 HOURS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS
ADDITIONAL INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE
LABELING REGARDING THE ADMINISTRATION OF BRAVELLE AND MENOPUR IN THE SAME SYRINGE
TO OVULATORY WOMEN AS PART OF AN ART CYCLE
REVISED DOSING SCHEDULE TO ADMINISTER AVANAFIL 15 MINUTES PRIOR TO SEXUAL ACTIVITY
DOSING INFORMATION IN PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA
DOSE MODIFICATION GUIDELINES FOR BORTEZOMIB WHEN GIVEN IN COMBINATION WITH
RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE
INITIATION OF VIMPAT THERAPY WITH A LOADING DOSE OF 200MG
LOWER LIMIT OF 15 MINUTES FOR THE INFUSION DURATION
UPDATES TO THE DOSAGE AND ADMINISTRATION SECTION OF THE LABELING TO REFLECT THE
RESULTS OF TWO SHORT TERM STUDIES EVALUATING THE SAFETY AND EFFICACY OF INTUNIV IN
CHILDREN AND ADOLESCENTS AGES 6 TO 17 WITH ADHD.
CHANGE IN TARGET DOSING TO 20MG TO 40MG ORALLY ONCE DAILY
ONCE DAILY DOSING IN PEDIATRIC PATIENTS 3 MONTHS OF AGE AND OLDER IN COMBINATION
WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 5 of 73

EXCLUSIVITY DOSING SCHEDULE

D-148
D-149
D-150
D-151
D-152
D-153

EXTENDED THE DURATION OF THE DOSING REGIMEN FROM 100 DAYS TO 200 DAYS POSTTRANSPLANTATION FOR THE PREVENTION OF CMV DISEASE IN PEDIATRIC KIDNEY TRANSPLANT
DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND
OLDER WITH ITP
1600MG DAILY FOR PATIENTS ON ADJUNCTIVE THERAPY WHO DID NOT ACHIEVE A SATISFACTORY
RESPONSE ON 1200MG DAILY DOSE
DOSING RECOMMENDATIONS FOR THE TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS COINFECTED WITH HIV-1
DOSING RECOMMENDATIONS AS NECESSARY FOR FEVER AND PAIN FOR AGES 6MO TO LESS THAN
12 YEARS AND 12 TO 17 YEARS.
IN COMBINATION WITH RIBAVIRIN FOR 12 WEEKS, FOR THE TREATMENT OF GENOTYPE 1,
CHRONIC HEPATITIS C TREATMENT EXPERIENCED PATIENTS WITH COMPENSATED CIRRHOSIS
BASED UPON THE RESULTS OF THE SIRIUS STUDY
EXCLUSIVITY INDICATION

I-1
I-2
I-3
I-4
I-5
I-6
I-7
I-8
I-9
I-10
I-11
I-12
I-13
I-14
I-15
I-16
I-17
I-18
I-19
I-20
I-21

I-22
I-23
I-24
I-25
I-26
I-27
I-28
I-29
I-30
I-31
I-32
I-33
I-34
I-35
I-36
I-37
I-38

DYSMENORRHEA
CHOLANGIOPANCREATOGRAPHY
INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY)
HYSTEROSALPINGOGRAPHY
TREATMENT OF JUVENILE ARTHRITIS
BIOPSY PROVEN MINIMAL CHANGE NEPHROTIC SYNDROME IN CHILDREN
ADULT INTRAVENOUS CONTRAST-ENHANCED COMPUTED TOMOGRAPHY OF THE HEAD AND BODY
PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
PREVENTION OF POSTOPERATIVE DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM IN TOTAL
HIP REPLACEMENT SURGERY
RELIEF OF MILD TO MODERATE PAIN
TREATMENT OF CUTANEOUS CANDIDIASIS
URINARY TRACT INFECTION (UTI) PREVENTION FOR PERIODS UP TO FIVE MONTHS IN WOMEN
WITH A HISTORY OF RECURRENT UTI
SEBORRHEIC DERMATITIS
PHOTOPHERESIS IN THE PALLIATIVE TREATMENT OF SKIN MANIFESTATIONS OF CUTANEOUS TCELL LYMPHOMA IN PERSONS NOT RESPONSIVE TO OTHER TREATMENT
STIMULATE THE DEVELOPMENT OF MULTIPLE FOLLICLES/OOCYTES IN OVULATORY PATIENTS
PARTICIPATING IN AN IN VITRO FERTILIZATION PROGRAM
MANAGEMENT OF CONGESTIVE HEART FAILURE
ENDOSCOPIC RETROGRADE PANCREATOGRAPHY
HERNIOGRAPHY
KNEE ARTHROGRAPHY
HIGH DOSE METHOTREXATE WITH LEUCOVORIN RESCUE IN COMBINATION WITH OTHER
CHEMOTHERAPEUTIC AGENTS TO DELAY RECURRENCE IN PATIENTS WITH NONMETASTATIC
OSTEOSARCOMA WHO HAVE UNDERGONE SURGICAL RESECTION OR AMPUTATION FOR THE PRIMARY
TUMOR
RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA
SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
TREATMENT OF RHEUMATOID ARTHRITIS
ADULT INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY OF THE HEAD, NECK, ABDOMINAL,
RENAL AND PERIPHERAL VESSELS
TREATMENT OF LIVER FLUKES
ADJUNCTIVE THERAPY TO DIET TO REDUCE THE RISK OF CORONARY ARTERY DISEASE
SELECTIVE ADULT VISCERAL ARTERIOGRAPHY
METASTATIC BREAST CANCER IN PREMENOPAUSAL WOMEN AS AN ALTERNATIVE TO OOPHORECTOMY
OR OVARIAN IRRADIATION
TREATMENT OF TINEA PEDIS
CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS IN THE SPINE AND
ASSOCIATED TISSUES
PEDIATRIC MYELOGRAPHY
ORAL USE OF DILUTED OMNIPAQUE INJECTION IN ADULTS FOR CONTRAST ENHANCED COMPUTED
TOMOGRAPHY OF THE ABDOMEN
ORAL USE IN ADULTS FOR PASS-THROUGH EXAMINATION OF THE GASTROINTESTINAL TRACT
PEDIATRIC CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING
ARTHROGRAPHY OF THE SHOULDER JOINTS IN ADULTS
RADIOGRAPHY OF THE TEMPOROMANDIBULAR JOINT IN ADULTS
CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS OF THE CENTRAL

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 6 of 73

EXCLUSIVITY INDICATION

I-39
I-40
I-41
I-42
I-43
I-44
I-45
I-46
I-47
I-48
I-49
I-50
I-51
I-52
I-53
I-54
I-55
I-56
I-57
I-58
I-59
I-60
I-61
I-62
I-63
I-64
I-65
I-66
I-67
I-68
I-69

I-70
I-71
I-72
I-73
I-74
I-75
I-76
I-77
I-78
I-79
I-80
I-81
I-82
I-83
I-84
I-85
I-86
I-87

NERVOUS SYSTEM IN CHILDREN (2 YEARS OF AGE AND OLDER)

TREATMENT OF ACUTE MYOCARDIAL INFARCTION
PRIMARY NOCTURNAL ENURESIS
MIGRAINE HEADACHE PROPHYLAXIS
HERPES ZOSTER
HERPES SIMPLEX ENCEPHALITIS
MAINTENANCE THERAPY IN HEALED DUODENAL ULCER PATIENTS AT DOSE OF 1 GRAM TWICE
DAILY
ACUTE TREATMENT OF VARICELLA ZOSTER VIRUS
USE IN PEDIATRIC COMPUTED TOMOGRAPHIC HEAD AND BODY IMAGING
TREATMENT OF PEDIATRIC PATIENTS WITH SYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS
(HIV) DISEASE
PEDIATRIC ANGIOCARDIOGRAPHY
TREATMENT OF TRAVELERS' DIARRHEA DUE TO SUSCEPTIBLE STRAINS OF ENTEROTOXIGENIC
ESCHERICHIA COLI
FOR USE IN WOMEN WITH AXILLARY NODE-NEGATIVE BREAST CANCER
TREATMENT OF PRIMARY DYSMENORRHEA AND FOR THE TREATMENT OF IDIOPATHIC HEAVY
MENSTRUAL BLOOD LOSS
PEDIATRIC EXCRETORY UROGRAPHY
TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
RENAL CONCENTRATION CAPACITY TEST
HYPERTENSION
EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER
INITIAL TREATMENT OF ADVANCED OVARIAN CARCINOMA IN COMBINATION WITH OTHER APPROVED
CHEMOTHERAPEUTIC AGENTS
ENDOSCOPICALLY DIAGNOSED ESOPHAGITIS, INCLUDING EROSIVE AND ULCERATIVE
ESOPHAGITIS, AND ASSOCIATED HEARTBURN DUE TO GASTROESOPHAGEAL REFLUX DISEASE
SINGLE APPLICATION TREATMENT OF HEAD LICE IN CHILDREN TWO MONTHS TO TWO YEARS IN
AGE
FEMALE ANDROGENETIC ALOPECIA
PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
ONCE DAILY TREATMENT AS INITIAL THERAPY IN THE TREATMENT OF HYPERTENSION
PREVENTION OF SUPRAVENTRICULAR TACHYCARDIAS
PREVENTION OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
UNCOMPLICATED GONORRHEA
TREATMENT OF ACUTE ASTHMATIC ATTACKS IN CHILDREN SIX YEARS OF AGE AND OLDER
CENTRAL PRECOCIOUS PUBERTY
SHORT TERM TREATMENT OF PATIENTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE
(GERD), AND FOR THE SHORT TERM TREATMENT OF ESOPHAGITIS DUE TO GERD INCLUDING
ULCERATIVE DISEASE DIAGNOSED BY ENDOSCOPY
USE IN COMBINATION WITH 5-FLUOROURACIL TO PROLONG SURVIVAL IN THE PALLIATIVE
TREATMENT OF PATIENTS WITH ADVANCED COLORECTAL CANCER
VARICELLA INFECTIONS (CHICKENPOX)
PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE
INITIATE AND MAINTAIN MONITORED ANESTHESIA CARE (MAC) SEDATION DURING DIAGNOSTIC
PROCEDURES
INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
TREATMENT OF ENDOSCOPICALLY DIAGNOSED EROSIVE ESOPHAGITIS
PREVENTION OF OSTEOPOROSIS
DERMAL INFECTIONS-TINEA PEDIS, TINEA CORPORIS, TINEA CRURIS DUE TO EPIDERMOPHYTON
FLOCCOSUM
CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY AND
INTRAVENOUS EXCRETORY UROGRAPHY
MANAGEMENT OF CHRONIC STABLE ANGINA AND ANGINA DUE TO CORONARY ARTERY SPASM
DIAGNOSIS AND LOCALIZATION OF ISCHEMIA AND CORONARY HEART DISEASE
PROPHYLAXIS IN DESIGNATED IMMUNOCOMPROMISED CONDITIONS TO REDUCE THE INCIDENCE OF
OROPHARYNGEAL CANDIDIASIS
TREATMENT OF TRAVELERS' DIARRHEA
ANGIOCARDIOGRAPHY, CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND
BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY IN CHILDREN
INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION
TREATMENT OF ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS
TREATMENT OF SECONDARY CARNITINE DEFICIENCY
RENAL IMAGING AGENT FOR USE IN CHILDREN

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 7 of 73

EXCLUSIVITY INDICATION
I-88
I-89
I-90
I-91
I-92
I-93
I-94
I-95
I-96
I-97
I-98
I-99
I-100
I-101
I-102
I-103

I-104
I-105
I-106
I-107
I-108
I-109
I-110
I-111
I-112
I-113
I-114
I-115
I-116
I-117
I-118
I-119
I-120
I-121
I-122
I-123
I-124
I-125
I-126
I-127
I-128

I-129
I-130
I-131
I-132
I-133
I-134

MANAGEMENT OF ENDOMETRIOSIS
EPIDURAL USE IN LABOR AND DELIVERY AS AN ANALGESIC ADJUNCT TO BUPIVACAINE
INTENSIVE CARE UNIT SEDATION
MONOTHERAPY USE FOR HYPERTENSION
ADJUNCTIVE THERAPY IN THE MANAGEMENT OF HEART FAILURE
PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN CHILDREN AGES 4-11 YEARS
USE WITH MRI IN ADULTS TO PROVIDE CONTRAST ENHANCEMENT AND FACILITATE
VISUALIZATION OF LESIONS IN THE BODY [EXCLUDING THE HEART]
TREATMENT OF LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
ORAL OR RECTAL USE IN CHILDREN FOR THE EXAMINATION OF THE GASTROINTESTINAL TRACT
TREATMENT OF CHILDREN WHO HAVE GROWTH FAILURE ASSOCIATED WITH CHRONIC RENAL
INSUFFICIENCY
PEDIATRIC ANESTHESIA IN CHILDREN 3 YEARS AND OLDER
TO DECREASE THE INCIDENCE OF CANDIDIASIS IN PATIENTS UNDERGOING BONE MARROW
TRANSPLANTATION WHO RECEIVE CYTOTOXIC CHEMOTHERAPY AND/OR RADIATION THERAPY
TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN-DEPENDENT
DIABETES MELLITUS AND RETINOPATHY
TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
PROPHYLAXIS AGAINST PNEUMOCYSTIS CARINII PNEUMONIA IN INDIVIDUALS WHO ARE
IMMUNOCOMPROMISED AND CONSIDERED TO BE AT RISK OF DEVELOPING PNEUMOCYSTIS CARINII
PNEUMONIA
TREATMENT OF PULMONARY AND EXTRAPULMONARY ASPERGILLOSIS IN PATENTS WHO ARE
INTOLERANT OF OR WHO ARE REFRACTORY TO AMPHOTERICIN B THERAPY
TREATMENT OF METASTATIC CARCINOMA OF THE BREAST AFTER FAILURE OF FIRST-LINE OR
SUBSEQUENT CHEMOTHERAPY
TREATMENT OF ACROMEGALY
VAGINAL CANDIDIASIS
EXPANDED USE-FOR ICU PATIENTS UNDERGOING LONG-TERM INFUSION DURING MECHANICAL
VENTILATION
TYPHOID FEVER
PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIOTHERAPY
TREATMENT OF PAGET'S DISEASE OF BONE
MANAGEMENT OF MODERATE TO SEVERE PAIN
TREATMENT OF PROSTATITIS
USE IN CHILDREN TO VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE BRAIN
(INTRACRANIAL LESIONS), SPINE, AND ASSOCIATED TISSUE
USE IN MRI IN ADULTS TO VISUALIZE LESIONS IN THE HEAD AND NECK
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
TO SLOW THE PROGRESSION FO CORONANY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY
HEART DISEASE
PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM FOLLOWING
KNEE REPLACEMENT SURGERY
TREATMENT OF ANEMIA CAUSED BY UTERINE LEIOMYOMATA IN WOMEN WHO FAIL IRON THERAPY
MAINTENANCE THERAPY FOR GASTRIC ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING
ACUTE ULCERS
EXPANDED PATIENT POPULATION -- USE IN ICU PATIENTS
PSORIASIS OF THE SCALP
RELIEF OF MILD TO MODERATE PAIN IN PATIENTS AGED 6 MONTHS AND OLDER
LEUCOCYTE LABELED SCINTIGRAPHY AS AN ADJUNCT IN THE LOCALIZATION OF INTRAABDOMINAL INFECTION AND INFLAMMATORY BOWEL DISEASE
EXPANSION OF CONSCIOUS SEDATION INDICATION TO INCLUDE SHORT THERAPEUTIC PROCEDURES
ADJUNCT TO THALLIUM- 201 MYOCARDIAL PERFUSION IN PATIENTS UNABLE TO EXERCISE
ADEQUATELY
TREATMENT OF ACYCLOVIR-RESISTANT HERPES IN IMMUNOCOMPROMISED PATIENTS
IN PT W/ CH DISEASE AND HYPERCHOLESTEROLEMIA: REDUCE RISK TOTAL MORTALITY BY
REDUCING CORONARY DEATH; REDUCE RISK NON-FATAL MI; REDUCE RISK UNDERGOING
MYOCARDIAL REVASCULARIZATION PROCEDURES; REDUCTION ELEVATED TOTAL AND LDL CHOL
LEVELS...
TREATMENT OF ALCOHOL DEPENDENCE
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
PERIPHERAL ARTERIOGRAPHY
TREATMENT OF MANIC PHASE OF BIPOLAR DISORDER
MANAGEMENT OF CHRONIC STABLE ANGINA
HEART FAILURE POST MYOCARDIAL INFARCTION

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 8 of 73

EXCLUSIVITY INDICATION
I-135
I-136
I-137
I-138
I-139
I-140
I-141
I-142
I-143
I-144
I-145
I-146
I-147
I-148
I-149
I-150
I-151
I-152
I-153
I-154
I-155
I-156
I-157
I-158
I-159

I-160
I-161
I-162
I-163
I-164
I-165

I-166
I-167
I-168
I-169
I-170
I-171
I-172
I-173
I-174
I-175
I-176
I-177

I-178
I-179

BONE METASTASES ASSOCIATED WITH MULTIPLE MYELOMA

IDIOPATHIC CHRONIC URTICARIA
PREVENTION OF METAL-INDUCED HEART BURN, ACID INDIGESTION, AND SOUR STOMACH WHEN
TAKEN 30 MINUTES PRIOR TO CONSUMING FOOD OR BEVERAGES
TREATMENT OF ACUTE RECURRENT GENITAL HERPES
PALLIATIVE TREATMENT OF ADVANCED BREAST CANCER IN PRE- AND PERIMENOPAUSAL WOMEN
PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN INDIVIDUALS WITH HIV INFECTION AT
RISK FOR DEVELOPING CMV DISEASE
TREATMENT OF HEMODYNAMICALLY STABLE PATIENTS WITHIN 24 HOURS OF ACUTE MYOCARDIAL
INFARCTION TO IMPROVE SURVIVAL
LOCALIZE MYOCARDIAL ISCHEMIA(REVERSIBLE DEFECT) AND INFARCTION (NON-REVERSIBLE
DEFECTS) IN EVALUATING MYOCARDIAL FUNCTION
EPISODIC TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
ENHANCEMENT OF MRI OF THE ADULT BODY INTERNAL ORGANS
0.1MMOL/KG AS A SINGLE INTRAVEOUS BOLUS FOR MRI OF THE CNS IN CHILDREN
CONTRAST ENHANCEMENT AND FACILITATION OF VISUALIZATION OF EXTRACRANIAL HEAD AND
NECK LESIONS
PREVENTION OF GALLSTONE FORMATION IN OBESE PATIENTS EXPERIENCING RAPID WEIGHT LOSS
TREATMENT OF ACUTE PNEUMOCYSTIC CARINI PNEUMONIA (PCP) IN HIV-INFECTED PATIENTS
WHOSE ALVEOLAR-ARTERIAL OXYGEN DIFFERENCE (AaDO2) IS LESS THAN OR EQUAL TO 55 TORR
TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER
TREATMENT OF OBSESSIVE COMPULSIVE DISORDER AND PANIC DISORDER
PREVENTION OF AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN
PEDIATRIC PATIENTS RECEIVING GENERAL ANESTHESIA
SLOWING THE PROGRESSION OF CORONARY ATHEROSCLEROSIS AND REDUCING THE RISK OF ACUTE
CORONARY EVENTS
MANAGEMENT OF SEVERE SPASTICITY [ENCOMPASES SPINAL AND CEREBRAL ORIGIN]
PATIENT POPULATION ALTERED TO INCLUDE PEDIATRIC USE
TREATMENT OF ONCHOMYCOSIS DUE TO DERMATOPHYTES (TINEA UNGUIUM) OF THE TOENAIL WITH
OR WITHOUT FINGERNAIL INVOLVEMENT
ADDITIONAL DATA REGARDING THE SAFE USE OF NORVASC IN PATIENTS WITH HEART FAILURE
TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS IN FEMALES
TREATMENT OF OSTEOLYTIC BONE METASTASES OF BREAST CANCER
FOR HYPERCHOLESTEROLEMIC PATIENTS WITHOUT CLINICALLY EVIDENT HEART DISEASE REDUCE
THE RISK OF MYOCARDIAL INFARCTION, REVASCULARIZATION, AND DEATH DUE TO
CARDIOVASCULAR CAUSES WITH NO INCREASE IN DEATH FROM NON-CARDIOVASCULAR CAUSES
TREATMENT OF BACTERIAL CORNEAL ULCERS
TREATMENT OF ADULT-ONSET OR CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENCY
FOR USE IN PATIENTS 6-11 YEARS OF AGE
TREATMENT OF PHOTOPHOBIA
CHRONIC BACTERIAL PROSTATITIS
MANAGEMENT OF ADULTS WITH ACTIVE, CLASSIC AND DEFINITIVE RHEUMATOID ARTHRITIS WHO
HAVE HAD INSUFFICIENT THERAPEUTIC RESPONSE TO OR ARE INTOLERANT OF AN ADEQUATE
TRIAL OF FULL DOSES OF ONE OR MORE NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
TREATMENT OF BULIMIA
COMPLICATED INTRA-ABDOMINAL INFECTIONS (USED IN COMBINATION WITH METRONIDAZOLE)
CAUSED BY MIXED AEROBIC/ANAEROBIC PATHOGENS
MANAGEMENT OF LOCALLY CONFINED STAGE B2-C METASTATIC CARCINOMA OF THE PROSTATE (IN
COMBINATION WITH LHRH AGONISTS)
USE IN COMBINATION WITH CORTICOSTEROIDS AS INITIAL CHEMOTHERAPY FOR THE TREATMENT
OF PATIENTS WITH PAIN RELATED TO ADVANCED HORMONE-REFRACTORY PROSTATE CANCER
PROPHYLACTIC USE DURING HEAD LICE EPIDEMICS
RELIEF OF SYMPTOMS OF THE COMMON COLD
TREATMENT OF INITIAL EPISODE OF GENITAL HERPES
PREOPERATIVELY FOR THE PREVENTION OF INFECTION IN TRANSRECTAL PROSTATE BIOPSY
PELVIC INFLAMMATORY DISEASE
TREATMENT OF TINEA CORPORIS AND TINEA CRURIS
TREATMENT OF POSTOPERATIVE INFLAMMATION IN PATIENTS WHO HAVE UNDERGONE CATARACT
EXTRACTION
TX OF MODERATE ACNE VULGARIS IN FEMALES,GREATER OR EQUAL TO 15YRS OF AGE,WHO HAVE
NO KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY,DESIRE CONTRACEPTION,HAVE
ACHIEVED MENARCHE AND ARE UNRESPONSIVE TO TOPICAL ANTI-ACNE MEDICATIONS
TREATMENT OF ONCHOMYCOSIS OF THE FINGERNAIL WITHOUT CONCOMITANT ONCHOMYCOSIS OF
THE TOENAIL WITH A PULSE DOSING REGIMEN
NOSOCOMIAL PNEUMONIA-MILD TO MODERATE AND SEVERE CAUSED BY HAEMOPHILUS INFLUENZAE
OR KLEBSIELLA PNEUMONIAE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 9 of 73

EXCLUSIVITY INDICATION
I-180
I-181
I-182
I-183
I-184
I-185
I-186
I-187
I-188
I-189
I-190

I-191
I-192

I-193
I-194
I-195

I-196
I-197
I-198

I-199
I-200
I-201
I-202
I-203
I-204
I-205
I-206
I-207
I-208
I-209
I-210

I-211
I-212
I-213
I-214
I-215
I-216

I-217
I-218
I-219
I-220

TREATMENT OF PLANTAR TINEA PEDIS (MOCCASIN TYPE)

TREATMENT OF PATIENTS WITH COMPLEX PARTIAL SEIZURES WITH AND WITHOUT SECONDARY
GENERALIZATION
TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME
MAINTENANCE THERAPY IN THE MANAGEMENT OF MILD TO MODERATE ASTHMA IN PEDIATRIC
PATIENTS AGES 6-11
TREATMENT OF PANIC DISORDER AT A RECOMMENDED DOSE RANGE OF 1 TO 2MG/DAY (MAXIMUM
OF 4MG)
PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR CAUSED BY OR PRESUMED TO BE CAUSED BY
PITYROSPORUM ORBICULARE (ALSO KNOWN AS MALASSEZIA FURFUR OR M. ORBICULARE)
PREVENTION OF FRACTURES IN THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
TREATMENT OF ACUTE SINUSITIS AND ACUTE EXACERBATION OF CHRONIC SINUSITIS
TREATMENT OF ACUTE OTITIS MEDIA IN PEDIATRIC PATIENTS
PLANAR IMAGING AS A SECOND LINE DIAGNOSTIC DRUG AFTER MAMMOGRAPHY TO ASSIST IN THE
EVALUATION OF BREAST LESIONS IN PATIENTS WITH AN ABNORMAL MAMMOGRAM OR A PALPABLE
BREAST MASS
ENDOMETRIAL THINNING AGENT PRIOR TO ENDOMETRIAL ABLATION FOR DYSFUNCTIONAL UTERINE
BLEEDING
THE PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN
PATIENTS UNDERGOING ABDOMINAL SURGERY WHO ARE AT RISK FOR THROMBOEMBOLIC
COMPLICATIONS AND A NEW DOSAGE REGIMEN, 40MG ONCE DAILY, FOR THIS INDICATION
TREATMENT OF PANIC DISORDER IN A RECOMMENDED DOSE RANGE OF 50 TO 200MG/DAY
CONGESTIVE HEART FAILURE
FOR USE OF LANSOPRAZOLE IN COMBINATION WITH CLARITHROMYCIN AND AMOXICILLIN FOR THE
ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE
OR A ONE-YEAR HISTORY OF DUODENAL ULCER
ACUTE TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
MAINTENANCE OF HEALING OF DUODENAL ULCER
FOR THE USE OF LANSOPRAZOLE IN COMBINATION WITH AMOXICILLIN FOR THE ERADICATION OF
HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A ONE-YEAR
HISTORY OF A DUODENAL ULCER
MONOTHERAPY AND COMBINATION THERAPY WITH SULFONYL UREAS IN THE TREATMENT OF TYPE
II DIABETES
TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR
EMPIRICAL THERAPY FOR FEBRILE NEUTROPENIC PATIENTS
SECOND-LINE TREAMENT OF AIDS-RELATED KAPOSI'S SARCOMA
MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
USE IN PEDIATRIC PATIENTS BETWEEN THE AGES OF 6 AND 11 FOR THE TREATMENT OF THE
NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
INITIAL ANTICONVULSANT TREATMENT OF STATUS EPILEPTICUS
TREATMENT OF EDEMA ASSOCIATED WITH CHRONIC RENAL FAILURE
FOR THE SUPPRESSION OF RECURRENT EPISODES OF GENITAL HERPES IN IMMUNOCOMPETENT
ADULTS
TREATMENT OF OBSESSIVE COMPULSIVE DISORDER IN THE PEDIATRIC POPULATION
PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT)
TO SLOW THE PROGRESSION OF CORONARY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY
HEART DISEASE AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL AND LDL CHOLESTEROL
TO TARGET LEVELS
FOR USE IN PEDIATRIC POPULATION
TREATMENT OF SYMPTOMS OF DRY MOUTH IN PATIENTS WITH SJOGREN'S SYNDROME
TEMPORARY RELIEF OF PAIN AND PHOTOPHOBIA IN PATIENTS UNDERGOING CORNEAL REFRACTIVE
SURGERY
TREATMENT OF OSTEOPOROSIS
PRE-PROCEDURAL APPLICATION TO ADULT MALE GENITAL SKIN PRIOR TO SITE-SPECIFIC
SUBCUTANEOUS INFILTRATION WITH LIDOCAINE FOR THE REMOVAL OF GENITAL WARTS
FOR THE LONG-TERM TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE
MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC
BRONCHITIS AND EMPHYSEMA
PREVENTION (DURING AND FOLLOWING HOSPITALIZATION) OF DEEP VEIN THROMBOSIS, WHICH
MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
USE OF LIPITOR AS AN ADJUNCTIVE THERAPY TO DIET FOR THE TREATMENT OF PATIENTS WITH
ELEVATED SERUM TRIGLYCERIDE LEVELS (FREDERICKSON TYPE IV)
USE OF LIPITOR BY PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDERICKSON TYPE
III) WHO DO NOT RESPOND ADEQUATELY TO DIET
TREATMENT OF EPISODIC- HEARTBURN, ACID INDIGESTION AND SOUR STOMACH

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 10 of 73

EXCLUSIVITY INDICATION
I-221

I-222
I-223
I-224
I-225
I-226
I-227
I-228
I-229
I-230

I-231
I-232
I-233

I-234

I-235
I-236
I-237
I-238
I-239
I-240

I-241

I-242
I-243
I-244
I-245
I-246
I-247
I-248

I-249
I-250

I-251
I-252
I-253
I-254
I-255
I-256

TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WITH AN ENLARGED PROSTATE

TO IMPROVE SYMPTOMS, REDUCE THE RISK OF ACUTE URINARY RETENTION AND REDUCE THE
RISK OF THE NEED OF SURGERY
PREVENTION OF ISCHEMIC COMPLICATIONS OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL
INFARCTION, WHEN CONCURRENTLY ADMINISTERED WITH ASPIRIN
USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH ALLERGIC AND
NONALLERGIC-PERENNIAL RHINITIS IN CHILDREN AGE 6-11 YEARS
FOR THE USE IN PEDIATRIC PATIENTS 4 TO 11 YEARS OF AGE FOR THE MANAGEMENT OF THE
NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
USE IN PATIENTS WITH PREVIOUS MI AND NORMAL CHOLESTEROL LEVELS, TO REDUCE RISK OF
RECURRENT MI, MYOCARDIAL REVASCULARIZATION, AND CEREBROVASCULAR DISEASE EVENTS
FIRST-LINE THERAPY FOR THE TREATMENT OF ADVANCED CARCINOMA OF THE OVARY IN
COMBINATION WITH CISPLATIN
SHORT-TERM TREATMENT OF SYMPTOMATIC GASTROESPHAGEAL REFLUX DISEASE (GERD)
PREVENTION OF MEAL INDUCED HEARTBURN AT A DOSE OF 75MG TAKEN 30-60MIN PRIOR TO A
MEAL
PRILOSEC (OMEPRAZOLE), AMOXICILLIN, AND CLARITHROMYCIN FOR THE ERADICATION OF H.
PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE
IN COMBINATION WITH CIS-PLATIN, FOR THE FIRST LINE TREATMENT OF NON-SMALL CELL
LUNG CANCER IN PATIENTS WHO ARE NOT CANDIDATES FOR POTENTIALLY CURATIVE SURGERY
AND/OR RADIATION
TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER
FAILURE OF PRIOR CHEMOTHERAPY
TREATMENT OF RECURRENT MUCOCUTANEOUS HERPES SIMPLEX INFECTIONS IN HIV-AFFECTED
PATIENTS AT A DOSE OF 500MG TWICE DAILY
PROPHYLACTIC USE TO REDUCE PERIOPERATIVE BLOOD LOSS AND THE NEED FOR BLOOD
TRANSUFSION IN PATIENTS UNDERGOING CARDIOPULMONARY BYPASS IN THE COURSE OF
CORONARY ARTERY BYPASS GRAFT SURGERY
FOR USE IN COMBINATION WITH CISPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS
WITH INOPERABLE LOCALLY ADVANCED (STAGE IIIA OR IIIB) OR METASTATIC (STAGE IV)
NON-SMALL CELL LUNG CANCER
PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 12 YEARS OF AGE AND OLDER
PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
MAINTENANCE TREATMENT OF ASTHMA AND PREVENTION OF BRONCHOSPASM IN PATIENTS 4 YEARS
OF AGE AND OLDER
ADJUNCTIVE TREATMENT OF LENNOX-GASTAUT SYNDROME IN PEDIATRIC AND ADULT PATIENTS
TREATMENT OF PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM AND RESULTANT METABOLIC BONE DISEASE
IN PATIENTS WITH MODERATE TO SEVERE CHRONIC RENAL FAILURE (CCR 15 TO 55ML/MIN) NOT
YET ON DIALYSIS
USE IN PHOTODYNAMIC THERAPY (PDT) FOR REDUCTION OF OBSTRUCTION AND PALLIATION OF
SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLY OBSTRUCTING ENDOBRONCHIAL
NONSMALL CELL LUNG CANCER
TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
AND IN THE TREATMENT OF VULVAR AND VAGINAL ATROPHY IN WOMEN WITH AN INTACT UTERUS
USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH THE COMMON COLD IN
CHILDREN AGE 5 TO 11 YEARS
REDUCE THE INCIDENCE OF BREAST CANCER IN WOMEN AT HIGH RISK FOR BREAST CANCER
TREATMENT OF ACUTE SINUSITIS
TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
USE IN CONVERSION TO MONOTHERAPY IN ADULTS WITH PARTIAL SEIZURES WHO ARE RECEIVING
TREATMENT WITH A SINGLE ENZYME-INDUCING ANTIEPILEPTIC DRUG
INPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITH/WITHOUT PULMONARY EMBOLISM
WHEN ADMIN WITH WARFARIN SODIM AND OUTPATIENT TREATMENT OF ACUTE DEEP VEIN
THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN ADMIN WITH WARFARIN SODIUM
TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS WITH COMPENSATED LIVER DISEASE
PREVIOUSLY UNTREATED WITH ALPHA INTERFERON THERAPY
PRIMARY PREVENTION OF CORONARY HEART DISEASE IN PATIENTS WITHOUT SYMPATOMATIC
CARDIOVASCULAR DISEASE WHO HAVE AVERAGE TO MODERATELY ELEVATED TOTAL-C AND LDL-C
AND BELOW AVERAGE HDL-C
TREATMENT OF GENERALIZED ANXIETY DISORDER
NEW COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET
PLUS METFORMIN
COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET
PLUS INSULIN
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS (LOSS OF BONE MASS)
PREVENTION OF PNEUMOCYSTIS CARINII PNEUMONIA (PCP)
USE IN TREATMENT OF SMALL CELL LUNG CANCER SENSITIVE DISEASE AFTER FAILURE OF

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 11 of 73

EXCLUSIVITY INDICATION

I-257
I-258
I-259
I-260
I-261
I-262
I-263
I-264
I-265
I-266
I-267
I-268
I-269
I-270
I-271
I-272

I-273

I-274
I-275
I-276
I-277
I-278
I-279
I-280
I-281
I-282
I-283

I-284
I-285
I-286
I-287
I-288

I-289

I-290
I-291
I-292
I-293

FIRST-LINE CHEMOTHERAPY
TREATMENT OF CHRONIC HEPATITIS B ASSOCIATED WITH EVIDENCE OF HEPATITIS B VIRAL
REPLICATION AND ACTIVE LIVER INFLAMATION
FOR PERENNIAL NONALLERGIC RHINITIS FOR AGES 4 AND ABOVE
PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM,
IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
EXPANDED PEDIATRIC USE IN CHILDREN YOUNGER THAN ONE MONTH OF AGE TO BIRTH (WITH A
GESTATIONAL AGE OF 37 WEEKS OR GREATER)
TREATMENT OF SOCIAL ANXIETY DISORDER
TREATMENT OR PREVENTION OF BRONCHOSPASM WITH REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE
AND FOR THE PREVENTION OF EXERCISE INDUCED BRONCHOSPASM IN CHILDREN AGES 4-12
TREATMENT OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION FOR THE
PREVENTION OF ISCHEMIC COMPLICATIONS IN PATIENTS ON CONCURRENT ASPIRIN THERAPY
PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIATION, INCLUDING TOTAL BODY
IRRADIATION (TBI) AND FRACTIONATED ABDOMINAL RADIATION
TREATMENT OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS 6 YEARS AND OLDER
USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS AGES 2-16 YEARS WITH
PARTIAL ONSET SEIZURES
USE IN PEDIATRIC PATIENTS 3 MONTHS OLD AND OLDER - FOR CORTICOSTEROID-RESPONSIVE
DERMATOSES
PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 7-11 YEARS OF AGE
PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH HIGHLY EMETOGENIC CANCER
CHEMOTHERAPY, INCLUDING CISPLATIN
ADJUVANT TREATMENT OF NODE-POSITIVE BREAST CANCER ADMINISTRERED SEQUENTIALLY TO
STANDARD DOXORUBICIN-CONTAINING COMBINATION CHEMOTHERAPY
TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
TREATMENT OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN MEN AND WOMEN RECEIVING
GLUCOCORTICOIDS IN A DAILY DOSE EQUIVALENT TO 7.5MG OR GREATER OF PREDNISONE AND
WHO HAVE LOW BONE MINERAL DENSITY
ADJUNCT TO DIET TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(HETEROZYGOUS FAMILIAL AND NON FAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON
TYPES IIA AND IIB)
USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED
TONIC-CLONIC SEIZURES
USE IN COMBINATION WITH METFORMIN AND SULFONYLUREA IN PATIENTS WITH TYPE 2
DIABETES
USE OF REZULIN IN COMBINATION WITH METFORMIN AND SULFONYLUREAS IN PATIENTS WITH
TYPE 2 DIABETES
TREATMENT OF TYPE III HYPERLIPOPROTEINEMIA
TREATMENT OF PATIENTS WITH ISOLATED HYPERTRIGLYCERIDEMIA (FREDERICKSON TYPE IV)
TREATMENT OF POST-TRAUMATIC STRESS DISORDER
USE OF CARNITOR INJECTION FOR THE PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY
IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
INCREASING HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (HETEROZYGOUS
FAMILIAL AND NONFAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON TYPES IIA AND IIB)
TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG
CANCER AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY
TO REDUCE THE INCIDENCE OF MODERATE TO SEVERE XEROSTOMIA IN PATIENTS UNDERGOING
POST-OPERATIVE RADIATION TREATMENT FOR HEAD AND NECK CANCER, WHERE THE RADIATION
PORT INCLUDES A SUBSTANTIAL PORTION OF THE PAROTID GLANDS
TO REDUCE THE NUMBER OF ADENOMATOUS COLORECTAL POLYPS IN FAMILIAL ADENOMATOUS
POLYPOSIS PATIENTS AS AN ADJUNCT TO USUAL CARE
TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN ADULTS AND
CHILDREN 3 YEARS OF AGE AND OLDER
TREATMENT OF PATIENTS WITH FREDERICKSON TYPE III
USE OF PRAVASTATIN IN PATIENTS WITH EVIDENT CORONARY HEART DISEASE TO REDUCE THE
RISK OF TOTAL MORTALITY BY REDUCING CORONARY DEATH
CHANGES IN SEVERAL SECTIONS OF THE INSERT TO INCORPORATE STATEMENTS CONCERNING THE
USE OF HIGH DOSES OF LISINOPRIL TO REDUCE THE RISK OF THE COMBINED OUTCOMES OF
MORTALITY AND HOSPITALIZATION IN PATIENTS WITH CONGESTIVE HEART FAILURE
USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES
MELLLITUS WHEN DIET AND EXERCISE WITH EITHER SINGLE AGENT DOES NOT ACHIEVE
ADEQUATE GLYCEMIC CONTROL
PREVENTION OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
TREATMENT OF CORTICOSTEROID-INDUCED OSTEOPOROSIS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 12 of 73

EXCLUSIVITY INDICATION
I-294
I-295
I-296

I-297
I-298
I-299

I-300
I-301
I-302
I-303
I-304
I-305
I-306

I-307
I-308
I-309
I-310
I-311
I-312
I-313
I-314
I-315

I-316

I-317
I-318
I-319
I-320
I-321
I-322
I-323
I-324

I-325
I-326
I-327
I-328
I-329
I-330
I-331
I-332
I-333
I-334

TREATMENT OF UNCOMPLICATED ACUTE ILLNESS DUE TO INFLUENZA A AND B IN PEDIATRIC

PATIENTS 7 YEARS AND OLDER WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 2 DAYS
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR WOMEN WITH AN INTACT UTERUS
LONG-TERM INTRAVENOUS TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH THE
SCLERODERMA SPECTRUM OF DISEASE IN NYHA CLASS III AND CLASS IV PATIENTS WHO DO NOT
RESPOND TO CONVENTIONAL THERAPY
SHORT-TERM TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IIA AND IIB HYPERLIPOPROTEINEMIA
USE OF CAMPTOSAR AS A COMPONENT OF FIRST-LINE THERAPY IN COMBINATION WITH 5FLUROURACIL AND LEUCOVARIN FOR PATIENTS WITH METASTATIC CARCINOMA OF THE COLON OR
RECTUM
PROPHYLAXIS FOR ASTHMA IN CHILDREN 2-5 YEARS OF AGE
TREATMENT OF SIGNS AND SYMPTOMS OF ALLERGIC CONJUNCTIVITIS
TREATMENT OF PEDIATRIC PATIENTS WITH PRADER-WILLI SYNDROME
INCREASING HDL-CHOLESTEROL IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA AND MIXED
DYSLIPIDEMIAS
TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IV
TREATMENT OF LEVOFLOXACIN SUSCEPTIBLE STRAINS OF PENICILLIN-RESISTANT
STREPTOCOCCUS PNEUMONIAE IN PATIENTS WITH COMMUNITY ACQUIRED PNEUMONIA
INDUCTION OF SPERMATOGENESIS IN MEN WITH PRIMARY AND SECONDARY HYPOGONADOTROPIC
HYPOGONADISM IN WHOM THE CAUSE OF INFERTILITY IS NOT DUE TO PRIMARY TESTICULAR
FAILURE
NEW COMBINATION USE OF METFORMIN AND INSULIN IN TYPE 2 DIABETES
TREATMENT OF PEDIATRIC PATIENTS WITH POLYARTICULAR COURSE JUVENILE RHEUMOTOID
ARTHRITIS WHO RESPONDED INADEQUATELY TO SALICYLATES OR OTHER NSAIDS
USE OF ACTONEL 35MG ONCE A WEEK TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
REDUCTION IN RISK OF MYOCARDIAL INFARCTION, STROKE, AND DEATH FROM CARDIOVASCULAR
CAUSES
ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS AGE
3 TO 12 YEARS
FIRST LINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR
HORMONE RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EXTENSION OF INDICATION TO PROVIDE FOR MAINTENANCE OF RESPONSE
TOPICAL ANESTHETIC FOR SUPERFICIAL MINOR SURGERY OF GENITAL MUCOUS MEMBRANES AND
AS AN ADJUNCT FOR LOCAL INFILTRATION ANESTHESIA IN GENITAL MUCOUS MEMBRANES
THROMBOPROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY
EMBOLISM,IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE
TO SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS
TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER PATIENTS WHO CONTINUE NSAID USE AND
REDUCING RISK OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS WITH HISTORY OF
DOCUMENTED GASTRIC ULCER WHO REQUIRE USE OF AN NSAID
PROPHYLAXIS OF INFLUENZA IN ADULTS AND ADOLESCENTS 13 YEARS AND OLDER
FIRSTLINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR
HORMONE RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
USE FOR SUSPECTED OR CONFIRMED METHANOL POISONING, EITHER ALONE OR IN COMBINATION
WITH HEMODIALYSIS
TREATMENT OF TYPE 2 DIABETES IN PEDIATRIC PATIENTS (AGES 10-16 YEARS)
JUVENILE RHEUMATOID ARTHRITIS
USE OF DIPRIVAN IN PATIENTS 3 MONTHS TO 16 YEARS
COLORECTAL CANCER
REDUCING NEUROLOGIC DISABILITY AND/OR FREQUENCY OF CLINICAL RELAPSES IN PATIENTS
WITH SECONDARY (CHRONIC) PROGRESSIVE, PROGRESSIVE RELAPSING, OR WORSENING
RELAPSING-REMITTING MULTIPLE SCLEROSIS
PREVENTION OF RELAPSE AND RECURRENCE OF DEPRESSION
GENERALIZED ANXIETY DISORDER
SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN
PATIENTS 5 YEARS AND OLDER
PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 5-6 YEARS OF AGE
UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND CONTROL OF DAYTIME AND NIGHTTIME
HEARTBURN SYSTOMS IN PATIENTS WITH GERD
TREATMENT OF MODERATE ACNE VULGARIS
EMPIRIC THERAPY IN FEBRILE NEUTROPENIC PATIENTS WITH SUSPECTED FUNGAL INFECTIONS
(EFTN)
TOPICAL TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR DUE TO MALASSEZIA FURFUR
(FORMERLY PITYROSPORUM ORBICULARE)
LONG-TERM TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 13 of 73

EXCLUSIVITY INDICATION

I-335
I-336

I-337
I-338
I-339
I-340
I-341
I-342

I-343
I-344
I-345
I-346
I-347
I-348

I-349
I-350

I-351
I-352
I-353
I-354
I-355
I-356
I-357
I-358
I-359
I-360
I-361

I-362
I-363
I-364
I-365
I-366
I-367

I-368
I-369
I-370

I-371
I-372
I-373
I-374
I-375

WHO FAIL TO MANIFEST CATCH-UP GROWTH BY TWO YEARS OF AGE

ADJUNCTIVE THERAPY IN PATIENTS TWO YEARS AND OLDER WITH SEIZURES ASSOCIATED WITH
LENNOX-GASTAUT SYNDROME
EXPANSION OF INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH PREDOMINATELY
CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO PATHOLOGIC MYOPIA OR
PRESUMED OCULAR HISTOPLASMOSIS
PATHOLOGICAL HYPERSECRETION ASSOCIATED WITH ZOLLINGER-ELLISON SNYDROME
MANAGEMENT OF ACUTE PAIN IN ADULTS AND TREATMENT OF PRIMARY DYSMENORRHEA
TREATMENT OF HEPATITIS B IN PEDIATRIC PATIENTS AGES 2-17 YEARS
ATOPIC DERMATITIS IN PEDIATRIC PATIENTS AGES 2-5
BREAST CANCER COMBINATION THERAPY
USE OF FORADIL FOR LONG-TERM, TWICE DAILY (MORNING AND EVENING) ADMINISTRATION IN
THE MAINTENANCE TREATMENT OF BRONCHO-CONSTRICTION IN PATIENTS WITH COPD INCLUDING
CHRONIC BRONCHITIS AND EMPHYSEMA
USE OF COREG FOR SEVERE HEART FAILURE
ACNE VULGARIS
TREATMENT OF POSTTRAUMATIC STRESS DISORDER
TREATMENT OF SYMPTOMATIC GASTRO ESOPHAGEAL REFLUX DISEASE (GERD)
TREATMENT OR PREVENTION OF BRONCHOSPASM IN CHILDREN 6 YEARS OF AGE AND OLDER WITH
OBSTRUCTIVE AIRWAY DISEASE
LONG-TERM, TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE
TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD (INCLUDING EMPHYSEMA AND CHRONIC
BRONCHITIS)
ACUTE CORONARY SYNDROME
TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND
GIRLS AT LEAST ONE YEAR POSTMENARCHAL, AGES 10 TO 17 YEARS, WITH A RECOMMENDED
DOSING RANGE OF 10 TO 40MG ONCE DAILY
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR ALL STRENGTHS
ANTICOAGULANT IN PATIENTS WITH OR AT RISK FOR HEPARIN-INDUCED THROMBOCYTOPENIA
UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS (PCI)
TREATMENT OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS
MANAGEMENT OF POST HERPETIC NEURALGIA
PREMENSTRUAL DYSPHORIC DISORDER
TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS, INCLUDING ZOLLINGER-ELLISON
SYNDROME
TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
TREATMENT OF PANIC DISORDER
TREATMENT OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH THE MENOPAUSE
TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN CHILDREN AGES
TWO UP TO AGE THREE
TREATMENT OF MULTIPLE MYELOMA AND DOCUMENTED BONE METASTASES FROM SOLID TUMORS, IN
CONJUNCTION WITH STANDARD ANTINEOPLASTIC THERAPY. PROSTATE CANCER SHOULD HAVE
PROGRESSED AFTER TREATMENT WITH AT LEAST ONE HORMONAL THERAPY
TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
ADJUVANT TREATMENT OF POST MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE EARLY
BREAST CANCER
TREATMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS
TREATMENT OF HEART FAILURE (NYHA CLASS II-IV) IN PATIENTS WHO ARE INTOLERANT TO AN
ACE INHIBITOR
PREVENTION OF RELAPSE FOLLOWING LONG-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
COMBINATION THERAPY WITH THIAZOLIDINEDIONE TO LOWER BLOOD GLUCOSE IN PTS WHOSE
HYPERGLYCEMIA CANNOT BE CONTROLLED BY DIET/EXERCISE PLUS MONOTHERAPY WITH ANY OF
THE FOLLOWING AGENTS:METFORMIN,SULFONYLUREAS,REPAGLINIDE,OR THIAZOLIDINEDIONES
USE OF GLUCOVANCE WITH A THIAZOLIDINEDIONE WHEN GLYCEMIC CONTROL IS NOT OBTAINED
WITH GLUCOVANCE ALONE
PREVENTION AND TREATMENT OF POSTOPERATIVE NAUSEA AND VOMITING
TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN CHILDREN, AGES 8-13
YEARS, WITH RECOMMENDED DOSE OF 20MG ONCE DAILY AND IN ADOLESCENTS, AGES 14-18
WITH A RECOMMENDED DOSE OF 40MG ONCE DAILY
HELICOBACTER PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
NOSOCOMIAL PNEUMONIA
TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
SHORT TERM TOPICAL TREATMENT OF MILD TO MODERATE PLAQUE-TYPE PSORIASIS OF NON
SCALP REGIONS
FIRST LINE THERAPY FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH
OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 14 of 73

EXCLUSIVITY INDICATION
I-376
I-377

I-378
I-379

I-380
I-381
I-382
I-383
I-384
I-385
I-386

I-387
I-388
I-389
I-390

I-391
I-392

I-393
I-394
I-395
I-396
I-397
I-398
I-399
I-400
I-401
I-402
I-403

I-404

I-405
I-406

I-407

I-408

TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE

CHRONIC MYELOID LEUKEMIA (CML)
USE OF BRAVELLE FOR MULTIPLE FOLLICULAR DEVELOPMENT (CONTROLLED OVARIAN
STIMULATION) DURING ASSISTED REPRODUCTIVE TECHNOLOGY CYCLES IN PATIENTS WHO HAVE
PREVIOUSLY RECEIVED PITUITARY SUPPRESSION
RELIEF OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS
2 YEARS OF AGE AND OLDER
USE TAXOTERE IN COMBINATION WITH CISPLATIN FOR THE TREATMENT OF PATIENTS WITH
UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHO HAVE
NOT PREVIOUSLY RECEIVED CHEMOTHERAPY FOR THIS CONDITION
TO TREAT PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER AT RISK FOR
EMERGENT SUICIDAL BEHAVIOR
TREATMENT OF COLD SORES (HERPES LABIALIS) IN ADULT AND ADOLESCENT PATIENTS 12
YEARS OF AGE AND OLDER
FOR NEWLY-DIAGNOSED HIGH GRADE MALIGNANT GLIOMA PATIENTS AS AN ADJUNCT TO SURGERY
AND RADIATION
TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
USE IN COMBINATION WITH INSULIN FOR THE TREATMENT OF PATIENTS WITH TYPE 2 DIABETES
MELLITUS
MODIFICATION OF THE INDICATION FOR COMMUNITY ACQUIRED PNEUMONIA TO ADD"INCLUDING
PENICILLIN-RESISTANT STRAINS, MIC PENICILLIN>=2MCG/ML TO STREPTOCOCCUS PNEUMONIAE
RAPAMUNE (SIROLIMUS) WITHIN AN IMMUNOSUPPRESSIVE REGIMEN THAT WOULD ALLOW FOR THE
WITHDRAWAL OF CYCLOSPORINE 2 TO 4 MONTHS AFTER RENAL TRANSPLANTATION IN PATIENTS
CONSIDERED AT LOW TO MODERATE IMMUNOLOGIC RISK FOR RENAL TRANSPLANT REJECTION
ADJUNCTIVE THERAPY OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS GREATER THAT OR EQUAL
TO 2 YEARS OF AGE
TREATMENT OF PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL
INFARCTION
SUPRESSION OF RECURRENT GENITAL HERPES IN HIV-INFECTED INDIVIDUALS
USE IN PTS AT HIGH RISK CORONARY EVENTS DUE TO EXISTING CORONARY HEART
DISEASE,DIABETES,PERIPHERAL VESSEL DISEASE,STROKE HISTORY,OTHER CV DISEASE TO
REDUCE RISK TOTAL MORTALITY BY REDUCING CORONARY DEATH,REDUCE NONFATAL MI &
ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT
UNDERGO ESOPHAGECTOMY
TX OF PED PATIENTS W/PH+ CHRONIC PHASE CML DISEASE RECUR AFTER STEM CELL TRNSPLT
OR RESIST TO INTERFERON ALPHA THERAPY.NO CONTROLLED TRIALS DEMONSTRATING A
CLINICAL BENEFIT SUCH AS IMPROVE IN DISEASE RELATED SX OR INCREASED SURVIVAL
CHRONIC BACTERIAL PROSTATITIS
USE IN PATIENTS WITH CORONARY HEART DISEASE TO REDUCE THE RISK OF UNDERGOING
CORONARY REVASCULARIZATION PROCEDURES
TO IMPROVE PHYSICAL FUNCTION
EXPANDED INDICATION TO INCLUDE THE ASSESSMENT OF VENTRICULAR FUNCTION IN SUBJECTS
BEING EVALUATED FOR HEART DISEASE AND/OR VENTRICULAR FUNCTION
EXTENDED PROPHYLAXIS IN PATIENTS UNDERGOING HIP FRACTURE SURGERY
IDIOPATHIC SHORT STATURE
TREATMENT OF CANDIDEMIA AND THE FOLLOWING CANDIDA INFECTIONS: INTRA-ABDOMINAL
ABSCESSES, PERITONITIS AND PLEURAL SPACE INFECTIONS
USE OF OLANZAPINE IN COMBINATION WITH LITHIUM OR VALPROATE FOR THE TREATMENT OF
ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER
LONGER-TERM EFFICACY OF ARIPIPRAZOLE IN THE TREATMENT OF SCHIZOPHRENIA
DIABETIC FOOT INFECTIONS WITHOUT CONCOMITANT OSTEOMYELITIS
USE OF VALTREX IN COMBINATION WITH SAFER SEX PRACTICES FOR THE REDUCTION OF THE
RISK OF TRANSMISSION OF GENITAL HERPES DURING SUPPRESIVE THERAPY OF THE SOURCE
PARTNER IN A HETEROSEXUAL COUPLE
MAINTENANCE TREATMENT OF BIPOLAR I DISORDER TO DELAY THE TIME TO OCCURRENCE OF
MOOD EPISODES (DEPRESSION, MANIA, HYPOMANIA, MIXED EPISODES) IN PATIENTS TREATED
FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
TREATMENT OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) USING AN INTERMITTENT DOSING
REGIMEN
PREVENTION OF CYTOMEGALOVIRUS DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS
TRANSPLANT PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV
SERONEGATIVE)
IMPROVE SURVIVAL OF STABLE PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
(EJECTION FRACTION<=40%) AND CLINICAL EVIDENCE OF CONGESTIVE HEART FAILURE AFTER
AN ACUTE MYOCARDIAL INFARCTION
STIMULATION OF PANCREATIC SECRETIONS TO FACILITATE THE INDENTIFICATION OF THE
AMPULLA OF VATER AND ACCESSORY PAPILLA DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 15 of 73

EXCLUSIVITY INDICATION
I-409
I-410
I-411
I-412
I-413
I-414

I-415
I-416
I-417
I-418
I-419
I-420
I-421
I-422
I-423
I-424
I-425
I-426
I-427
I-428

I-429
I-430
I-431
I-432
I-433

I-434

I-435
I-436
I-437
I-438
I-439
I-440
I-441

I-442

I-443

ESOPHAGEAL CANDIDIASIS
USE OF ADVAIR DISKUS 250/50 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
ASSOCIATED WITH CHRONIC BRONCHITIS
EXPANDED INDICATION FOR USE IN COMBINATION WITH ANTIDIABETIC DRUGS IN THE
THIAZOLIDINEDIONE CLASS
MONOTHERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES
ASSOCIATED WITH BIPOLAR I DISORDER
ADJUNCTIVE THERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES
ASSOCIATED WITH BIPOLAR I DISORDER
PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM
(PE) IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE TO
SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS
SEVERE HYPERTENSION WHEN THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL
EXCEEDS THE RISK OF INITIATING COMBINATION THERAPY
THE USE OF CIPRO XR FOR COMPLICATED URINARY TRACT INFECTIONS AND ACUTE
UNCOMPLICATED PYELONEPHRITIS
USE IN THE LONG TERM TREATMENT OF BIPOLAR I DISORDER
ADJUNCTIVE THERAPY W/ MOOD STABILIZERS (LITHIUM OR DIVALPROEX) IN THE TREATMENT OF
ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDERS
MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I
DISORDER
TOPICAL TREATMENT OF CLINICALLY TYPICAL, NONHYPERKERATOTIC, NONHYPERTROPHIC
ACTINIC KERATOSES ON THE FACE OR SCALP IN IMMUNOCOMPETENT ADULTS
TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND PYELONEPHRITIS DUE TO E.COLI
FOR PED PATIENTS (1-17) NOT AS FIRST CHOICE
INDICATED FOR THE IN-HOSPITAL SHORT-TERM (UP TO 4 HOURS) REDUCTION IN BLOOD
PRESSURE IN PEDIATRIC PATIENTS
ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH MODERATE TO SEVERE
CHRONIC RENAL INSUFFICIENCY NOT YET ON DIALYSIS
FLOXATIN IN COMBINATION WITH INFUSIONAL 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV)
FOR THE TREATMENT OF PATIENTS PREVIOUSLY UNTREATED FOR ADVANCED COLORECTAL CANCER
TREATMENT OF ACUTE PULMONARY EMBOLISM WHEN ADMINISTERED IN CONJUNCTION WITH
WARFARIN SODIUM
TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN
ADMINISTERED IN CONJUNCTION WITH WARFARIN SODIUM
FOR USE IN COMBINATION WITH PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS
WITH METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR ANTHRACYCLINE CONTAINING
ADJUVANT CHEMOTHERAPY UNLESS ANTHRACYCLINES WERE CLINICALLY CONTRAINDICATED
FOR USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH ANDROGEN
INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER
FOR USE IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS
NOSOCOMIAL PNEUMONIA AND COMMUNITY-ACQUIRED PNEUMONIA CAUSED BY STREPTOCOCCUS
PNEUMONIAE INDICATION EXPANDED TO INCLUDE MULTI-DRUG RESISTANT STRAINS
TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA CAUSED BY MULTI-DRUG RESISTANT
STREPTOCOCCUS PNEUMONIAE
TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA IN
IMMUNOCOMPETENT ADULTS, WITH A MAXIMUM TUMOR DIAMETER OF 2.0CM, LOCATED ON THE
TRUNK (EXCLUDING ANOGENITAL SKIN), NECK, OR EXTREMITIES (EXCLUDING HANDS AND FEET)
PREVENTION OF CARDIOVASCULAR DISEASE IN ADULT PATIENTS WITHOUT CLINICALLY EVIDENT
HEART DISEASE, BUT WITH MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE TO REDUCE
RISK OF MI AND RISK FOR REVASCULARIZATION PROCEDURES AND ANGINA
CHRONIC IDIOPATHIC CONSTIPATION
FOR USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR THE ADJUVANT
TREATMENT OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER
TREATMENT OF ACUTE MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER
EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, NEUTROPENIC PATIENTS
USED TO TREAT ADULTS WITH GROWTH HORMONE DEFICIENCY
FOR THE REPLACEMENT OF ENDOGENOUS GROWTH HORMONE IN ADULTS WITH GROWTH HORMONE
DEFICIENCY
USE COMBINATION WITH INFUSIONAL 5-FU/LV FOR ADJUVANT TREATMENT STAGE III COLON
CANCER PTS WHO HAVE UNDERGONE COMPLETE RESECTION PRIMARY TUMOR-BASED ON
IMPROVEMENT IN DISEASE FREE SURVIVAL, NO DEMONSTRATED BENEFIT OVERALL SURVIVAL
AFTER 4YRS
USED FOR CANDIDEMIA IN NONNEUTROPENIC PATIENTS AND THE FOLLOWING CANDIDA
INFECTIONS: DISSEMINATED INFECTIONS IN SKIN & INFECTIONS IN ABDOMEN, KIDNEY,
BLADDER WALL, AND WOUNDS
TREATMENT OF NASAL POLYPS IN PATIENTS 18 YEARS OF AGE AND OLDER

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 16 of 73

EXCLUSIVITY INDICATION
I-444

I-445

I-446

I-447
I-448

I-449

I-450
I-451
I-452
I-453
I-454
I-455

I-456

I-457
I-458

I-459
I-460
I-461

I-462
I-463
I-464
I-465
I-466
I-467
I-468
I-469
I-470
I-471

I-472
I-473
I-474
I-475
I-476

USE OF PROTONIX IV FOR INJECTION AS STAND ALONE THERAPY FOR THE SHORT-TERM
TREATMENT OF PATIENTS HAVING GASTROESOPHAGEAL REFLUX (GERD) WITH A HISTORY OF
EROSIVE ESOPHAGITIS
TO IMPROVE (COMPARED TO 4.25% DEXTROSE) LONG-DWELL ULTRAFILTRATION AND CLEARANCE
OF CREATININE AND UREA NITROGEN IN PATIENTS WITH HIGH AVERAGE OR GREATER TRANSPORT
CHARACTERISTICS, AS DEFINED USING THE PERITONEAL EQUILIBRATION TEST (PET)
EXTENDED ADJUVANT TREATMENT OF EARLY BREAST CANCER IN POSTMENOPAUSAL WOMEN WHO
HAVE RECEIVED 5 YRS ADJUVANT TAMOXIFEN THERAPY-EFFECTIVENESS BASED ON AN ANALYSIS
OF DISEASE FREE SURVIVAL IN PATIENTS TREATED FOR A MEDIAN 24 MONTHS
USE OF COPEGUS (RIBAVIRIN) FOR TREATMENT OF CHRONIC HEPATITIS C IN ADULT PATIENTS
COINFECTED WITH HIV IN COMBINATION WITH PEGASYS (PEGINTERFERON ALFA-2A)
TREATMENT OF HEART FAILURE (NYHA CLASS II-IV AND EJECTION FRACTION <=40%) TO
REDUCE THE RISK OF DEATH FROM CARDIOVASCULAR CAUSES AND TO REDUCE HOSPITALIZATIONS
FOR HEART FAILURE
TO IMPROVE WAKEFULNESS IN TWO NEW PATIENT POPULATIONS WITH EXCESSIVE SLEEPINESS:
THOSE WITH OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME AND THOSE WITH SHIFT WORK
SLEEP DISORDER
TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED HIGH GRADE GLIOMAS CONCOMITANTLY WITH
RADIOTHERAPY AND THEN AS ADJUVANT TREATMENT
MANAGEMENT OF ENDOMETRIOSIS ASSOCIATED PAIN
EXPANDED INDICATION TO INCLUDE TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE
RECEIVED AT LEAST 1 PRIOR THERAPY
USE IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN WHEN DIET, EXERCISE AND BOTH
AGENTS DO NOT RESULT IN ADEQUATE GLYCEMIC CONTROL (TRIPLE THERAPY)
MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CHRON'S DISEASE INVOLVING
THE ILEUM AND/OR THE ASCENDING COLON FOR UP TO 3 MONTHS
MODIFIED HEART FAILURE INDICATION TO INCLUDE TREATMENT OF HEART FAILURE IN
PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION (NYHA CLASS II-IV; EJECTION
FRACTION LESS THAN OR EQUAL TO 40%
TO REDUCE CARDIOVASCULAR DEATH AND TO REDUCE HEART FAILURE HOSPITALIZATIONS.
INCLUDES ADDITIONAL INFORMATION ON THE ADDED EFFECT ON THESE OUTCOMES WHEN USED
WITH AN ACE INHIBITOR
TREATMENT OF PATIENTS UNDERGOING ABDOMINAL SUREGERY WHO ARE AT RISK FOR
THROMBOEMBOLIC COMPLIATIONS
USE OF BIVALIRUDIN FOR INJECTION WITH PROVISIONAL USE OF GLYCOPROTEIN IIB/IIA
INHIBITOR (GPI) AS LISTED IN THE CLINICAL TRIALS REPLACE-2 SECTION FOR USE AS AN
ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)
NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE (NDD-CKD) PATIENTS RECEIVING OR NOT
RECEIVING AN ERYTHROPOIETIN
TREATMENT OF DIARRHEA CAUSED BY CRYPTOSPORIDIUM PARVUM IN NON-HIV INFECTED
PATIENTS 12 YEARS OF AGE AND OLDER
USE AS A SINGLE AGENT FOR ADJUVANT TREATMENT IN PATIENTS WITH DUKES' C COLON
CANCER WHO HAVE UNDERGONE COMPLETE RESECTION OF THE PRIMARY TUMOR WHEN TREATMENT
WITH FLUOROPYRIMIDINE THERAPY ALONE IS PREFERRED
LONG TERM TREATMENT OF IDIOPATHIC SHORT STATURE
TREATMENT OF PATIENTS POST MYOCARDIAL INFARCTION
TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME
PERENNIAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND
OLDER
FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS
USE OF TOPIRAMATE AS INITIAL MONOTHERAPY IN PATIENTS 10 YEARS OF AGE AND OLDER
WITH PARTIAL ONSET OR PRIMARY GENERALIZED TONIC CLONIC SEIZURES
USE IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE TO REDUSE THE RISK OF
CARDIOVASCULAR MORTALITY OR NON-FATAL MYOCARDIAL INFECTION
RELIEF OF THE SIGNS AND SYMPTOMS OF PAUCIARTICULAR OR POLYARTICULAR COURSE
JUVENILE RHEUMATOID ARTHRITIS IN PATIENTS 2 YEARS OF AGE AND OLDER
DIABETIC PERIPHERAL NEUROPATHIC PAIN
INDICATED TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS WITH
TYPE 2 DIABETES AND WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH
MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE
USE IN PATIENTS WITH ANGIOGRAPHICALLY DOCUMENTED CORONARY ARTERY DISEASE
USE IN COMBINATION WITH GEMCITABINE FOR THE FIRST LINE TREATMENT OF PATIENTS WITH
LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER
TREATMENT OF IRON DEFICIENCY ANEMIA IN PERITONEAL DIALYSIS DEPENDANT CHRONIC
KIDNEY DISEASE IN PATIENTS RECIEVING AN ERYTHROPOIETIN
PREVENTION OF NAUSEA AND VOMITTING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF
MODERATELY EMETOGENIC CANCER CHEMOTHERAPY
TREATMENT OF DIABETIC FOOT INFECTIONS WITHOUT OSTEOMYELITIS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 17 of 73

EXCLUSIVITY INDICATION
I-477

I-478
I-479

I-480
I-481
I-482
I-483
I-484
I-485
I-486
I-487
I-488
I-489
I-490

I-491
I-492
I-493

I-494

I-495

I-496
I-497
I-498
I-499

I-500
I-501
I-502

I-503
I-504
I-505

I-506
I-507

I-508
I-509
I-510

TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY METHICILLIN

SUSCEPTIBLE STAPHYLOCOCCUS AUREUS, ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR
ENTEROBACTER CLOACAE
FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN CHILDREN
WITH EPILEPSY AGED 2-4 YEARS
TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS CAUSED BY E.COLI, B. FRAGILIS,
S.ANGINOSUS, S.CONSTELLATUS, E. FAECALIS, P. MIRABILIS, C. PERFRINGENS, B.
THETAIOTAOMICRON OR PEPTOSTREPTOCOCCUS SPECIES
PROPHYLAXIS OF INFLUENZA FOR PATIENTS BETWEEN 1-12 YEARS OF AGE
INDICATED FOR THE ADJUVANT TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR
POSITIVE EARLY BREAST CANCER
TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH
OR WITHOUT PSYCHOTIC FEATURES
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
FOR THE RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS
TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS
WHO HAVE UNDERGONE CATARACT EXTRACTION
ANGIOMAX IS INDICATED FOR PATIENTS WITH, OR AT RISK OF, HIT/HITTS UNDERGOING PCI
INDICATED FOR THE RELIEF OF THE INFAMMATORY AND PRURITIC MANIFESTATIONS OF
CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YRS OF AGE OR OLDER
MAINTENANCE THERAPY IN BIPOLAR I DISORDER
FOR USE IN PEDIATRIC PATIENTS WITH TYPE I DIABETES
FOR USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE TREATMENT OF
PATIENTS WITH ADVANCED GASTRIC ADENOCARCINOMA, INCLUDING ADENOCARCINOMA OF
GASTROESOPHAGEAL JUNCTION, WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR ADVANCED
DISEASE
INFLUENZA PROPHYLAXIS
MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC OR MIXED EPISODES IN BIPOLAR I
DISORDER, WITH OR WITHOUT PSYCHOTIC FEATURES
ADMINISTERED IN COMBINATION WITH FENOFIBRATE, AS ADJUNCTIVE THERAPY TO DIET FOR
THE REDUCTION OF ELEVATED TOTAL-C, LDL-C, APO B, AND NON-HDL-C IN PATIENTS WITH
MIXED HYPERLIPIDEMIA
CLINICAL DATA IN SUPPORT OF AVANDAMET AS AN ADJUNCT TO DIET AND EXERCISE TO
IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT
WITH DUAL ROSIGLITAZONE AND METFORMIN THERAPY IS APPROPRIATE
ADJUVANT TX OF POSTMENOPAUSAL WOMEN WITH ESTROGEN-RECEPTOR POSITIVE EARLY BREAST
CANCER WHO HAVE RECEIVED 2 TO 3 YRS OF TAMOXIFEN AND ARE SWITCHED TO AROMASIN FOR
COMPLETION OF A TOTAL OF 5 CONSECUTIVE YRS OF ADJUVANT HORMONAL THERAPY
LONG TERM TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME IN PATIENTS
WHO HAVE OPEN EPIPHYSES
PREVENTION OF SEASONAL MAJOR DEPRESSIVE EPISODES IN PATIENTS WITH SEASONAL
AFFECTIVE DISORDER
PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
USE OF GEMZAR IN COMBINATION WITH CARBOPLATIN FOR THE TREATMENT OF PATIENTS WITH
ADVANCED OVARIAN CANCER THAT HAS RELAPSED AT LEAST 6 MONTHS AFTER COMPLETION OF
PLATINUM-BASED THERAPY
FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF MULTIPLE MYELOMA
PATIENTS WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN IMMUNOCOMPETANT PATIENTS
WITH A SINGLE DOSE OF FAMCICLOVIR 1500 MG.
FOR PTS WITH ST-SEGMENT ELEVATION ACUTE MYOCARDIAL INFARCTION, PLAVIX TO REDUCE
RATE OF DEATH FROM ANY CAUSE AND THE RATE OF A COMBINED ENDPOINT OF DEATH,
REINFARCTION OR STROKE. NOT KNOWN TO PERTAIN TO PTS WHO RECEIVE PRIMARY
ANGIOPLASTY
TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER
TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME
TREATMENT OF STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA), INCLUDING
THOSE WITH RIGHT SIDED INFECTIVE ENDOCARDITIS, CAUSED BY METHICILLIN-SUSCEPTIBLE
AND METHICILLIN-RESISTANT ISOLATES
ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 12 AND OVER
WITH JUVENILE MYOCLONIC EPILEPSY
ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND
GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
PREMENSTRUAL DYSPHONIC DISORDER
TREATMENT OF IRRATABILITY ASSOCIATED WITH AUTISTIC DISORDER
ADULT DERMAFIBROSARCOMA PROTUBERANS (DFSP)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 18 of 73

EXCLUSIVITY INDICATION
I-511
I-512
I-513
I-514
I-515
I-516
I-517
I-518
I-519

I-520

I-521
I-522

I-523

I-524
I-525
I-526
I-527

I-528
I-529
I-530
I-531
I-532
I-533
I-534
I-535
I-536
I-537
I-538
I-539
I-540
I-541
I-542
I-543

I-544
I-545
I-546
I-547

I-548
I-549
I-550
I-551

ADULT MYELODYSPLASTIC SYNDROME/MYELOPROLIFERATIVE DISEASES (MDS/MDP)

ADULT PH+ ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) MONOTHERAPY
ADULT AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM)
ADULT HYPEREOSINOPHILIC SYNDROME/CHRONIC EOSINOPHILIC LEUKEMIA (HES/CEL)
PROPHYLAXIS OF SURGICAL SITE INFECTION FOLLOWING ELECTIVE COLORECTAL SURGERY
PRIMARY GENERALIZED TONIC CLONIC SEIZURES IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS
OF AGE AND OLDER
TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEG SYNDROME (RLS)
TREATMENT OF SHORT STATURE OR GROWTH FAILURE IN CHILDREN WITH SHOX (SHORT STATURE
HOMEOBOX CONTAINING GENE) DEFICIENCY WHOSE EPIPHYSES ARE NOT CLOSED
USE OF TAXOTERE (DOCETAXEL) INJECTION CONCENTRATE IN COMBINATION WITH CISPLATIN
AND FLUOROURACIL FOR THE INDUCTION OF PATIENTS WITH INOPERABLE LOCALLY ADVANCED
SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)
USE OF EXENATIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE USING A
THIAZOLIDINEDIONE ALONE OR IN COMBINATION WITH METFORMIN BUT HAVE NOT ACHIEVED
ADEQUATE GLYCEMIC CONTROL
TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 YEAR
PRIOR THERAPY
TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YRS OF AGE, WHO HAVE NO
KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY, AND HAVE ACHIEVED MENARCHE,
IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL.
USE IN ADULT PATIENTS WITH CLINICALLY EVIDENT CORONARY HEART DISEASE TO REDUCE THE
RISK OF NONFATAL MYOCARDIAL INFARCTION, FATAL AND NONFATAL STROKE, ANGINA,
REVASCULARIZATION PROCEDURES AND HOSPITALIZATION FOR CONGESTIVE HEART FAILURE
GENERALIZED ANXIETY DISORDER (GAD)
USE OF 0.5MG/0.1MG FOR PREVENTION OF POST-MENOPAUSAL OSTEOPOROSIS
TREATMENT OF HYPONATREMIA IN HOSPITALIZED PATIENTS
ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED
EPILEPSY
TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE,
SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH MENOPAUSE
TREATMENT OF DEMENTIA OF THE ALZHEIMER'S TYPE IN PATIENTS WITH SEVERE ALZHEIMER'S
DISEASE
PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION IN PATIENTS 15 YEARS OF AGE AND
OLDER
MAINTENANCE TREATMENT OF SCHIZOPHRENIA
TREATMENT OF BACTERIAL VAGINOSIS IN NON-PREGNANT FEMALES
ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI)
EXTENDED TREATMENT OF SYMPTOMATIC VENOUS THROMBOEMBOLISM (VTE) AND/OR PULMONARY
EMBOLISM TO REDUCE THE RECCURENCE OF VTE IN PATIENTS WITH CANCER
MANAGEMENT OF FIBROMYALGIA
FOR THE TREATMENT OF SHORT STATURE IN CHILDREN WITH NOONAN SYNDROME
LONG TERM TREATMENT OF PANIC DISORDER
SHORT TERM TREATMENT OF PANIC DISORDER
REDUCTION IN RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH
OSTEOPOROSIS OR AT HIGH RISK FOR INVASIVE BREAST CANCER
TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGES 13-17
TREATMENT OF BIPOLAR I DISORDER IN CHILDREN AGES 10-12 AND ADOLESCENTS AGES 13-17
EXPANSION OF PATIENT POPULATION FOR HEAD AND NECK CANCER FROM "INOPERABLE"
PATIENTS TO ALL PATIENTS
USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE INDUCTION TREATMENT OF
PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
(SCCHN)
ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 16 AND OVER
WITH JUVENILE MYOCLONIC EPILEPSY
ADJUNCTIVE TREATMENT TO TREAT PATIENTS WITH MAJOR DEPRESSIVE DISORDER
TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA
ADJUNCTIVE THERAPY TO DIET TO SLOW THE PROGRESSION OF ARTHEROSCLEROSIS IN ADULT
PATIENTS AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL-C AND LDL-C TO TARGET
LEVELS
SEASONAL ALLERGIC RHINITIS IN PATIENTS 6 THROUGH LESS THAN 12 YEARS OF AGE
USE OF AVALIDE TABLETS AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED
MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS
TREATMENT OF HYPERTENSION IN PEDIATRIC PATIENTS 6-16 YEARS OF AGE
TREATMENT OF SHORT STATURE IN CHILDREN WITH TURNER'S SYNDROME

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 19 of 73

EXCLUSIVITY INDICATION
I-552

I-553
I-554
I-555
I-556
I-557
I-558

I-559
I-560
I-561
I-562
I-563

I-564
I-565
I-566
I-567
I-568

I-569
I-570
I-571
I-572
I-573
I-574
I-575
I-576
I-577
I-578
I-579
I-580
I-581
I-582
I-583
I-584
I-585
I-586
I-587
I-588
I-589

ADJUNCTIVE TREATMENT FOR RADIOIODINE ABLATION OF THYROID TISSUE REMNANTS IN

PATIENTS WHO HAVE UNDERGONE THYROIDECTOMY FOR WELL-DIFFERENTIATED THYROID CANCER
AND WHO DO NOT HAVE EVIDENCE OF METASTATIC THYROID CANCER
FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS
WITH TYPE 2 DIABETES MELLITUS
TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA
PERITONIS AND ABSCESSES
TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN
PEDIATRIC PATIENTS AGED 10-17 YEARS
PREVENTION OF POST OPERATIVE NAUSEA AND VOMITING FOR UP TO 24 HOURS FOLLOWING
SURGERY
USE OF AMITIZA (LUBIPROSTONE) 8 MCG TWICE DAILY FOR TREATMENT OF IRRITABLE BOWEL
SYNDROME WITH CONSTIPATION IN WOMEN GREATER THAN OR EQUAL TO 18 YEARS OLD
MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION AND REDUCING EXACERATIONS IN PATIENTS
WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND
EMPHYSEMA
ADJUNCTIVE THERAPY ADDED TO LITHIUM OR VALPROATE IN SHORT TERM TREATMENT OF
BIPOLAR DISORDER, MANIC OR MIXED
MAINTENANCE TREATMENT FOR BIPOLAR I DISORDER, AS ADJUNCTIVE THERAPY TO LITHIUM OR
DIVALPROEX
LONG-TERM TREATMENT OF SOCIAL ANXIETY DISORDER
MAINTENANCE TREATMENT OF ATTENTION-DEFICIT DISORDER (ADHD) IN CHILDREN AND
ADOLESCENTS
ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SIEZURES
IN ADULTS AND CHILDREN 16 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED
EPILEPSY
TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
USE OF DUTASTERIDE IN COMBINATION WITH TAMSULOSIN FOR THE TREATMENT OF SYMPTOMATIC
BENIGN PROSTATIC HYPERPLASIA (BPH)
MANAGEMENT OF FIBROMYALGIA
INITIAL THERAPY IN PATIENTS LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD
PRESSURE GOALS
USE OF APTIVUS, CO-ADMINISTERED W/RITONAVIR, FOR COMBINATION ANTIRETROVIRAL
TREATMENT OF HIV-1 INFECTED PED (AGE 2-18 YRS) PATIENTS WHO ARE TREATMENTEXPERIENCED AND INFECTED W/HIV-1 STRAINS RESISTANT TO MORE THAN ONE PROTEASE
INHIBITOR
TREATMENT OF CHRONIC HEPATITIS B
TREATMENT OF CHICKEN POX IN IMMUNOCOMPETENT PEDIATRIC PATIENTS 2 TO <18 YEARS OF
AGE
NON-SMALL CELL LUNG CANCER IN COMBINATION WITH CISPLATIN AND AS SINGLE AGENT FOR
NONSQAUMOUS NON-SMALL CELL LUNG CANCER
TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) WITH
NO CATCH-UP BY AGE 2-4 YRS.
TO TREAT PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDICKSON TYPE III
HYPERLIPOPROTEINEMIA) AS AN ADJUNCT TO DIET
MONOTHERAPY IN THE TREATMENT OF BIPOLAR DEPRESSION
MONOTHERAPY IN THE TREATMENT OF BIPOLAR MANIA
ADJUNCTIVE THERAPY IN THE TREATMENT OF BIPOLAR MANIA
SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER
PROCUDURES
EXPANSION OF INDICATION TO INCLUDE TREATMENT OF HIV IN TREATMENT NAIVE ADULTS
TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL
ATROPHY, DUE TO MENOPAUSE AND NEW TWICE WEEKLY DOSING REGIMEN FOR THIS INDICATION
INDOLENT B-CELL NON-HODGKINS LYMPHOMA (NHL) THAT HAS PROGRESSED DURING OR WITHIN
SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN
TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
ADJUVANT TREATMENT OF ADULT PATIENTS FOLLOWING COMPLETE GROSS RESECTION OF KIT
(CD117) POSITIVE GASTOINTESTINAL STROMAL TUMORS (GIST)
TREATMENT AND PREVENTION OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN PATIENTS
EXPECTED TO BE ON GLUCOCORTICOIDS FOR AT LEAST 12 MONTHS
TREATMENT OF SHORT STATURE IN PEDIATRIC PATIENTS SMALL FOR GESTATIONAL AGE WHO DO
NOT MANIFEST CATCH UP GROWTH BY AGE 2 TO 4 YEARS
COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
ADDITIONAL PATHOGENS TO COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS INDICATION
ADDITIONAL PATHOGENS TO COMPLICATED INTRA-ABDOMINAL INFECTIONS INDICATION
TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH OLANZAPINE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 20 of 73

EXCLUSIVITY INDICATION
I-590
I-591
I-592
I-593
I-594
I-595
I-596
I-597
I-598
I-599
I-600
I-601

I-602
I-603
I-604
I-605
I-606
I-607
I-608

I-610
I-611

I-612

I-613
I-614
I-615
I-616
I-617
I-618
I-619
I-620

I-621

I-622
I-623
I-624

I-625
I-626
I-627

ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN

COMBINATION WITH OLANZAPINE)
TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH FLUOXETINE
ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN
COMBINATION WITH FLUOXETINE)
TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD)
INDICATION EXPANDED TO INCLUDE PATIENTS WHO HAVE EXPERIENCED A FIRST CLINICAL
EPISODE AND HAVE MRI FEATURES CONSISTENT WITH MULTIPLE SCLEROSIS
PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT
OF BIPOLAR I DISORDER
MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION INDICATION EXPANDED TO INCLUDE DELAY
IN CLINICAL WORSENING
PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
KIDNEY DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
FOR USE AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO
ACHIEVE THEIR BLOOD PRESSURE GOALS
MAINTENANCE TREATMENT IN PATIENTS WITH ADVANCED OR METASTATIC NONSQUAMOUS NONSMALL CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF
PLATINUM-BASED FIRST LINE CHEMOTHERAPY
TREATMENT OF MEN AND WOMEN WITH OSTEOPOROSIS ASSOCIATED WITH SUSTAINED SYSTEMIC
GLUCOCORTICOID THERAPY AT HIGH RISK FOR FRACTURE
GOUT FLARES
PREVENTION OF CMV DISEASE IN KIDNEY AND HEART TRANSPLANT PATIENTS 4 MONTHS TO 16
YEARS AT HIGH RISK
ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS FOR SCHIZOAFFECTIVE DISORDER
TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY
INDICATION EXPANDED TO INCLUDE TREATMENT OF PULMONARY ARTENAL HYPERTENSION (WHO
GROUP I) IN PATIENTS WITH CLASS II SYMPTOMS
REDUCE LDL-C LEVELS IN BOYS AND POSTMENARCHAL GIRLS, 10 TO 17 YEARS OF AGE, WITH
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AS MONOTHERAPY OR IN COMBINATION WITH A
STATIN AFTER FAILING AN ADEQUATE TRIAL OF DIET THERAPY
TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR WOMEN WHO CHOOSE TO USE INTRAUTERINE
CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION
TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND
POSTMENARCHAL GIRLS, AGES 10 TO 17 YEARS, WITH A RECOMMENDATION DOSING RANGE OF 5
TO 20 MG ONCE DAILY
MICARDIS 80 MG FOR REDUCTION OF THE RISK OF MYOCARDIAL INFARCTION, STROKE, OR
DEATH FROM CARDIOVASCULAR CAUSES IN PATIENTS 55 YEARS OF AGE OR OLDER AT HIGH RISK
OF DEVELOPING MAJOR CARDIOVASCULAR EVENTS WHO ARE UNABLE TO TAKE ACE INHIBITORS
MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 18
YEARS OF AGE
SHORT TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC
PATIENTS AGES FIVE YEARS AND OLDER
MAINTENANCE TREATMENT OF BIPOLAR DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS
AGES 6-17 YEARS OF AGE
MAINTENANCE OF GENERALIZED ANXIETY DISORDER (GAD)
ADJUNCTIVE THERAPY IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
INTRAVENOUS CONTRAST ENHANCED COMPUTER TOMOGRAPHY OF THE HEAD AND BODY
FOR USE IN COMBINATION WITH LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN
WITH HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER THAT OVEREXPRESSES THE
HER2 RECEPTOR FOR WHOM HORMONAL THERAPY IS INDICATED
PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE, BASED ON THE RESULTS OF
JUSTIFICATION FOR THE USE OF STATINS IN PRIMARY PREVENTION; AN INTERVENTION TRIAL
EVALUATING ROSUVASTATIN (JUPITER)
ADJUNCTIVE THERAPY FOR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS
THIRTEEN YEARS OF AGE AND OLDER
TREATMENT OF SIGNS AND SYMPTOMS OF ADVANCED IDIOPATHIC PARKINSON'S DISEASE
MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL
CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF PLATINUMBASED FIRST-LINE CHEMOTHERAPY
PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY
RELIEF OF NASAL CONGESTION ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS
AND PEDIATRIC PATENTS 2 YEARS OF AGE AND OLDER
TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 21 of 73

EXCLUSIVITY INDICATION

I-628
I-629
I-630

I-631
I-632
I-633
I-634
I-635
I-636
I-637
I-638
I-639
I-640
I-641
I-642
I-643
I-644
I-645
I-646
I-647
I-648
I-649
I-650
I-651
I-652
I-653
I-654
I-655

I-656

I-657
I-658

I-659
I-660
I-661
I-662
I-663
I-664
I-665

I-666

CHRONIC MYELOID LEUKEMIA (PH & CML) IN CHRONIC PHASE.

MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS

ADJUNCTIVE THERAPY WITH EITHER LITHIUM OR VALPROATE FOR THE ACUTE TREATMENT OF

MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

TREATMENT OF PATIENTS WITH SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) ASSOCIATED

WITH TUBEROUS SCLEROSIS (TS) WHO REQUIRE THERAPEUTIC INTERVENTION BUT ARE NOT

CANDIDATES FOR CURATIVE SURGICAL RESECTION.

PREVENTION OF RELAPSE TO OPIOID DEPENDENCE FOLLOWING OPIOID DETOXIFICATION

MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN

MAINTENANCE TREATMENT OF BIPOLAR I DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE

TREATMENT OF SEVERE HYPERCALCEMIA IN PATIENTS WITH PRIMARY HYPERPARATHYROIDISM WHO

ARE UNABLE TO UNDERGO PARATHYROIDECTOMY

ADJUNCTIVE TREATMENT WITH LONG-ACTING ORAL PSYCHOSTIMULANTS FOR THE TREATMENT OF

ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

TREATMENT OF EXTERNAL GENITAL AND PERIANAL WARTS/CONDYLOMA ACUMINATA IN PATIENTS

12 YEARS OR OLDER

USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL IN THE PALLIATIVE TREATMENT OF

PATIENTS WITH ADVANCED METASTATIC COLORECTAL CANCER

FOR PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET)

THAT ARE UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC.

TREATMENT OF PROGRESSIVE, WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS IN

PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC DISEASE

MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS

TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA (BPH)

TREATMENT OF ERECTILE DYSFUNCTION (ED) AND THE SIGNS AND SYMPTOMS OF BENIGN

PROSTATIC HYPERPLASIA (BPH)

REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NONVALVULAR

ATRIAL FIBRILLATION.

MONOTHERAPY IN PATIENTS 13 YEARS OF AGE AND OLDER WITH PARTIAL SEIZURES WHO ARE

RECEIVING THERAPY WITH A SINGLE ANTIEPILEPTIC DRUG (AED)

MAINTENANCE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS

SIGNS AND SYMPTOMS OF ADVANCED PARKINSON'S DISEASE (APD)

SIGNS AND SYMPTOMS OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)

TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO

CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION

TREATMENT OF PATIENTS WITH ADVANCED SOFT TISSUE SARCOMA (STS) WHO HAVE RECEIVED

PRIOR CHEMOTHERAPY

TREATMENT OF ADULTS WITH RENAL ANGIOMYOLIPOMA AND TUBEROUS SCLEROSIS COMPLEX

(TSC), NOT REQUIRING IMMEDIATE SURGERY

MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH SPINAL CORD INJURY

MANAGEMENT OF POSTHERPETIC NEURALGIA

TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS

MAGNETIC RESONANCE ANGIOGRAPHY (MRA) TO EVALUATE ADULTS WITH KNOWN OR SUSPECTED

RENAL OR AORTO-ILIO-FEMORAL OCCLUSIVE VASCULAR DISEASE

TREATMENT OF POSTMENOPAUSAL WOMEN WITH ADVANCED HORMONE RECEPTOR-POSITIVE,HER2NEGATIVE BREAST CANCER (ADVANCED HR+BC) IN COMBINATION WITH EXEMESTANE, AFTER

FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE

MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY

(DPN) IN ADULTS WHEN A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC IS NEEDED FOR

AN EXTENDED PERIOD OF TIME

PLAQUE PSORIASIS OF THE SCALP

FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER,

IN COMBINATION WITH CARBOPLATIN, IN PATIENTS WHO ARE NOT CANDIDATES FOR CURATIVE

SURGERY OR RADIATION THERAPY

PLAQUE PSORIASIS OF THE BODY

TREATMENT OF DEEP VEIN THROMBOSIS

TREATMENT OF PULMONARY EMBOLISM

REDUCTION IN RISK FOR DEEP VEIN THROMBOSIS AND THE REDUCTION IN RISK FOR PULMONARY

EMBOLISM

IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC

CASTRATION-RESISTANT PROSTATE CANCER

TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE

INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY

TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS OF AGE AND OLDER WITH

(NTDT)SYNDROMES AND WITH A (LIC) OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY

WEIGHT (MG FE/G DW) AND SERUM FERRITIN GREATER THAN 300MCG/L

TREATMENT OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 22 of 73

EXCLUSIVITY INDICATION

I-667

I-668
I-669

I-670
I-671

I-672
I-673

I-674

I-675
I-676
I-677

I-678

I-679
I-680
I-681
I-682
I-683
I-684

I-685
I-686
I-687
I-688
I-689
I-690
I-691
I-692
I-693
I-694
I-695
I-696
I-697
I-698

POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL) IN COMBINATION WITH CHEMOTHERAPY

TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC

GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE BEEN PREVIOUSLY TREATED WITH

IMATINIB MESYLATE AND SUNITINIB MALATE

PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT

SCINTIGRAPIC ASSESSMENT OF SYMPATHETIC INNERVATION OF THE MYOCARDIUM BY

MEASUREMENT OF THE HEART TO MEDIASTINUM (H/M) RATIO OF RADIOACTIVITY UPTAKE IN

PATIENTS WITH NYHA CLASS II OR CLASS III HEART FAILURE AND LVEF LESS THAN 35%

TREATMENT OF OPIOID-INDUCED CONSTIPATION (OIC) IN ADULTS WITH CHRONIC, NON-CANCER

PAIN

FIRSTLINE TREATMENT OF PATIENTS WITH METASTATIC NON- SMALL CELL LUNG CANCER

(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19

DELETIONS OR EXON 21(L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA- APPROVED

TEST

USE IN PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED

AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB

TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA/VENTILATOR-ASSOCIATED BACTERIAL

PNEUMONIA (HABP/VABP) CAUSED BY SUSCEPTIBLE ISOLATES OF S. AUREUS (INCL.

METHICILLIN-SUSCEPTIBLE AND -RESISTANT ISOLATES) WHEN ALTERNATIVE TREATMENTS ARE

NOT SUITABLE

TREATMENT OF PATIENTS WITH DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

(BIPOLAR DEPRESSION) AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR

VALPROATE

MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER

FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARACINOMA OF THE PANCREAS,

IN COMBINATION WITH GEMCITABINE

TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE,

DIFFERENTIATED THYROID CARCINOMA (DTC) THAT IS REFRACTORY TO RADIOCACTIVE IODINE

TREATMENT

TRAMETINIB, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH

UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED

BY AN FDA-APPROVED TEST

RISK REDUCTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING THERAPEUTIC

ENDOSCOPY IN ADULTS

TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT

LEAST ONE PRIOR THERAPY

PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT) WHICH MAY LEAD TO PULMONARY EMBOLISM

(PE), IN ADULT PATIENTS WHO HAVE UNDERGONE HIP OR KNEE REPLACEMENT

TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) IN PATIENTS

WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR 5-10 DAYS

TO REDUCE THE RISK OF RECURRENCE OF DVT AND PE IN PATIENTS WHO HAVE BEEN

PREVIOUSLY TREATED

PREVENTION OF ACUTE NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES

OF EMETOGENIC CANCER CHEMOTHERAPY, INCLUDING HIGHLY EMETOGENIC CANCER CHEMOTHERAPY

IN PEDIATRIC PATIENTS AGED 1 MONTH TO LESS THAN 17 YEARS

EXPANDED INDICATION OF RASAGILINE AS AN ADD-ON THERAPY TO STABLE DOSES OF DOPAMINE

AGONISTS IN THE TREATMENT OF EARLY PARKINSON'S DISEASE

INDICATED FOR THE TREATMENT OF DIABETIC MACULAR EDEMA IN PATIENTS WHO ARE

PSEUDOPHAKIC OR ARE PHAKIC AND SCHEDULED FOR CATARACT SURGERY

GUIDING SENTINEL LYMPH NODE BIOPSY, USING A HAND-HELD GAMMA COUNTER IN PATIENTS

WITH CLINICALLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY

GADAVIST IS INDICATED WITH MRI TO DETECT THE PRESENCE AND EXTENT OF MALIGNANT

BREAST DISEASE

TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION

INDICATED FOR THE TREATMENT OF DEEP VEIN THROMBOSIS (DVT)

INDICATED TO REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY

EMBOLISM (PE) FOLLOWING INITIAL THERAPY

INDICATED FOR MANAGEMENT OF OSTEOARTHRITIS PAIN.

TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-REISISTANT PROSTATE CANCER (CRPC)

TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES

FOR PHOTOTHERAPY OR SYSTEMIC THERAPY

REVISED INDICATION FOR BORTEZOMIB IN THE TREATMENT OF PATIENTS WITH MANTLE CELL

LYMPHOMA

USE AS MONOTHERAPY IN THE TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH

EPILEPSY AGE 17 YEARS AND OLDER

FOR USE IN COMBINATION WITH SOFOSBUVIR FOR THE TREATMENT OF PATIENTS WITH CHRONIC

HEPATITIS C VIRUS GENOTYPE 1 INFECTION

SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 23 of 73

EXCLUSIVITY INDICATION

I-699
I-700
I-701

I-702
I-703
I-704

I-705
I-706
I-707

I-708
I-709
I-710
I-711

I-712

I-713
I-714
I-715
I-716

I-717
I-718
I-719
I-720

ANTIDEPRESSANTS

FOR TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA WHO HAVE HAD AN INADEQUATE

RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA

TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S DISORDER (6-18 YEARS)

FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE, WELL-OR MODERATELYDIFFERENTIATED, LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC

NEUROENDOCRINE TUMORS (GEP-NETS) TO IMPROVE PROGRESSIONFREE SURVIVAL.

FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM MACROGLOBULINEMIA

MODERATE TO SEVERE BINGE EATING DISORDER (BED)

EXPANDED INDICATION TO INCLUDE PATIENTS WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1

RNA <50 COPIES/ML) ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS WITH

NO HISTORY OF TREATMENT FAILURE IN ORDER TO REPLACE THEIR CURRENT REGIMEN

TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO HAVE AN R117H

MUTATION IN THE CFTR GENE

EXPANDED INDICATION FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA

POMALYST, IN COMBINATION WITH DEXAMETHASONE, IS INDICATED FOR PATIENTS WITH

MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR THERAPIES AND HAVE

DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST

THERAPY

DAILY TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER

TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS

ADJUNCTIVE THERAPY FOR THE TREATMENT OF PRIMARY GENERALIZED TONIC - CLONIC (PG TC)

SEIZURES IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE OR OLDER.

INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF

THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT

RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY.

EXPANDED INDICATION FOR USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR

THE TREATMENT OF PATIENTS WITH RELAPSED MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO

THREE PRIOR LINES OF THEREPY

REVISIONS TO THE LABELING TO PERMIT THE USE OF ZUBSOLV AS INITIAL ("INDUCTION")

TREATMENT OF OPIOID DEPENDENCE

EXTENDS THE 2011 APPROVAL OF BRILINTA FOR USE BEGINNING WITH ACS TO USE BEGINNING

MORE REMOTE FROM MYOCARDIAL INFRACTION

FOR THE ADDITION OF THE INDICATION FOR MONOTHERAPY TREATMENT IN PARTIAL-ONSET

SEIZURES IN ADULTS.

REVISED INDICATION TO INCLUDE LANGUAGE ABOUT THE BENEFITS OF USING LETAIRIS IN

COMBINATION WITH TADALAFIL TO REDUCE THE RISK OF DISEASE PROGRESSION AND

HOSPITALIZATION FOR WORSENING PAH AND TO IMPROVE EXERCISE ABILITY, BASED ON THE

AMBITION STUDY

EXPANDED INDICATION TO INCLUDE THE TREATMENT OF CHRONIC HEPATITIS C GENOTYPE 4

EXPANDED INDICATION TO INCLUDE SUBJECTS INFECTED WITH CHRONIC HEPATITIS C,

GENOTYPE 6 VIRUS INFECTION BASED UPON THE RESULTS OF THE ELECTRON- 2 STUDY

EXPANDED INDICATION TO INCLUDE THE TREATMENT OF SUBJECTS WITH GENOTYPE 5 CHRONIC

HEPATITIS C VIRUS INFECTION BASED ON THE RESULTS FROM STUDY GS-US-337-119.

EXPANDED INDICATION TO INCLUDE TREATMENT OF GENOTYPE 4, CHRONIC HEPATITIS C VIRUS

INFECTION BASED UPON THE RESULTS FROM STUDIES ION-4 AND GS-US-337-119.

EXCLUSIVITY MISCELLANEOUS

M-1
M-2

M-3
M-4
M-5
M-6
M-7
M-8
M-9

INFORMATION REGARDING SUPERIORITY CLAIM OVER RANITIDINE FOR DAY AND NIGHT

HEARTBURN ADDED TO CLINICAL STUDIES SECTION

APPROVAL FOR ADDTION TO CLINICAL PHARMACOLOGY SECTION OF THE LABEL REGARDING (1)

IMPROVEMENT IN BONE MINERAL DENSITY IN CHILDHOOD-ONSET ADULT GROWTH HORMONE

DEFICIENT PATIENTS AND (2) INCREASES IN SERUM ALKALINE PHOSPHATASE

ADDITION OF EFFICACY AND SAFETY INFORMATION IN WHICH FOSAMAX WAS USED

CONCOMITANTLY WITH ESTROGEN ALONE OR WITH ESTROGEN PLUS PROGESTIN

CHANGES TO PEDIATRIC USE SECTION TO PROVIDE INFORMATION REGARDING SAFETY AND

EFFICACY IN PEDIATRIC PATIENTS AS YOUNG AS 2 YEARS OLD

INFORMATION REGARDING EFFECTS IN PATIENTS WITH ASTHMA ON CONCOMITANT INHALED

CORTICOSTEROIDS IN CLINICAL PHARMACOLOGY SECTION

ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH GLUCOPHAGE/GLYBURIDE

COMBINATION ADDED TO CLINICAL PHARMACOLOGY AND DOSING AND ADMINISTRATION

CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS; DOSAGE AND ADMINISTRATION INFORMATION

ADDITIONAL INFORMATION FOR THE USE OF SONATA CAPSULES FOR UP TO 5 WEEKS (35

NIGHTS) OF TREATMENT IN A CONTROLLED TRIAL SETTING

ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING OF TEXT AND TWO TABLES

CONTAINING INFORMATION FOR THE PRESCRIBING PHYSICIAN ON BLOOD PRESSURE, HEART

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 24 of 73

EXCLUSIVITY MISCELLANEOUS

M-10
M-11
M-12
M-13
M-14
M-15
M-16
M-17
M-18
M-19
M-20
M-21
M-22
M-23
M-24
M-25
M-26

M-27
M-28
M-29
M-30

M-31
M-32
M-33
M-34
M-35
M-36
M-37

M-38

M-39
M-40
M-41

M-42
M-43

M-44
M-45

RATE, AND HEART RATE VARIABILITY

INFORMATION REGARDING MAINTENANCE OF AN ANTIDEPRESSANT EFFECT UP TO 1 YEAR OF
DOSING
USE FOR LONG-TERM TREATMENT OF POSTTRAUMATIC STRESS DISORDER
NEW LANGUAGE FOR PEDIATRIC USE
INFORMATION FROM PEDIATRIC STUDIES ADDED TO CLINICAL PHARMACOLOGY, PRECAUTIONS,
AND DOSAGE AND ADMINISTRATION
ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
LONGER TERM EFFICACY INFORMATION FOR RISPERIDONE IN THE TREATMENT OF SCHIZOPHRENIA
CHANGE IN WORDING OF THE PEDIATRIC SECTION OF THE PACKAGE INSERT
INFORMATION REGARDING USE OF ULTANE IN PEDIATRIC PATIENTS WITH CONGENITAL HEART
DISEASE
INFORMATION DENOTING THE EFFICACY OF REMERON IN MAINTAINING A RESPONSE IN PATIENTS
WITH MAJOR DEPRESSIVE DISORDER (MDD)
INFORMATION REGARDING USE IN PEDIATRIC PATIENTS TWO YEARS OF AGE AND OLDER
LABELING REVISIONS RELATED TO MCCUNE ALBRIGHT SYNDROME
COMPARISON DATA ON THE ANTIHYPERTENSIVE EFFECTS OF ATACAND AND COZAAR
CHANGE IN TIME TO ONSET OF ACTION
INFORMATION REGARDING ELIMINATION ADDED TO CLINICAL PHARMACOLOGY, STUDY RESULTS IN
PATIENTS WITH HEPATIC AND RENAL IMPAIRMENT
INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC
SAFETY INFORMATION
ADDITIONAL SAFETY & PK INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF
AGE ADDED TO PKG INSERT
INCORPORATION OF INFORMATION CONTAINED IN THE PEG-INTRON PACKAGE INSERT INTO THE
REBETOL PACKAGE INSERT AND MEDGUIDE-PEG-INTRON WAS APPROVED FOR USE IN COMBINATION
WITH REBETOL FOR TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION ON 8/7/01
INFORMATION DESCRIBING ASPIRIN ENDOSCOPY STUDY AND THE MAXIMUM RECOMMENDED DOSE
FOR PATIENTS WITH MODERATE HEPATIC INSUFFICIENCY
INFORMATION FROM A STUDY IN PEDIATRIC PATIENTS IN ASSOCIATION WITH A NEUROLOGICAL
CONDITION
LABELING CHANGES TO PROVIDE INFORMATION IN THE MANAGEMENT OF OBESITY IN
ADOLESCENTS AGED 12 TO 16 YEARS
CHANGES TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION
SECTIONS OF LABELING CONCERNING USE OF LOTENSIN IN PEDIATRIC PATIENTS WITH
HYPERTENSION
INFORMATION FOR USE IN PEDIATRIC PATIENTS WITH CHRONIC KIDNEY DISEASE STAGE 5
(END-STAGE RENAL DISEASE)
ADDITIONAL LANGUAGE TO CLINICAL PHARMACOLOGY AND CLINICAL STUDIES
INFORMATION FOR USE OF ADVAIR DISKUS 100/50 IN CHILDREN 4 TO 11 YEARS OF AGE WITH
ASTHMA
EXPANDED INFORMATION TO PEDIATRIC USE SUBSECTION OF LABELING IN RESPONSE TO
PEDIATRIC WRITTEN REQUEST
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH ACTOS IN COMBINATION
WITH METFORMIN, A SULFONYLUREA, OR INSULIN ADDED TO CLINICAL PHARMACOLOGY
ADDITION OF INFORMATION TO CLINICAL STUDIES REGARDING PREVENTION OF CARDIOVASCULAR
DISEASE
INFORMATION ADDED TO THE LABELING THAT DETAILS INFORMATION RELATIVE TO STUDIES
DONE IN PEDIATRIC POPULATIONS IN THE CLINICAL PHARMACOLOGY AND PEDIATRIC USE
SUBSECTIONS
SAFETY AND IOP-LOWERING EFFECTS OF TRUSOPT HAVE BEEN DEMONSTRATED IN PEDIATRIC
PATIENTS IN A 3 MONTH, MULTI-CENTER DOUBLE MASKED ACTIVE-TREATMENT-CONTROLLED
TRIAL
FOR LABELING CHANGES BASED ON RESULTS OF THE SPD422-202 CLINICAL STUDY REPORT
(CSR) SUBMITTED IN RESPONSE TO THE WRITTEN REQUEST
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED IN PEDIATRIC PATIENTS
WITH LEUKEMIA ADDED TO PRECAUTIONS
REVISION TO THE PEDIATRIC USE PRECAUTIONS OF THE PRESCRIBING INFORMATION TO
INCORPORATE THE RESULTS FROM THE CAPPS-169 STUDY ENTITLED "THE EFFECT OF ORTHO
TRICYCLEN ON BONE MINERAL DENISTY IN PEDIATRIC SUBJECTS WITH ANOREXIA NERVOSA"
ADDITION OF A GERIATRIC USE SUBSECTION TO THE PRECAUTIONS SECTION OF THE PACKAGE
INSERT AND GERIATRIC DOSING INFORMATION
INCLUSION OF RESULTS OF STUDY-"PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND
PILOT EFFICACY OF ILOPROST AS ADD ON THERAPY WITH BOSENTAN IN SUBJECTS WITH
PULMONARY ARTERIAL HYPERTENSION
CLINICAL INFORMATION ADDED TO THE PEDIATRIC USE SUBSECTION OF PRECAUTIONS
REGARDING THE USE OF NOVOLOG IN ADOLESCENTS WITH TYPE I DIABETES AGE 6 TO 18
INFORMATION ADDED TO CLINICAL TRIALS SECTION OF LABELING - EFFECTS OF HUMATROPE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 25 of 73

EXCLUSIVITY MISCELLANEOUS

M-46
M-47
M-48
M-49
M-50

M-51
M-52

M-53
M-54
M-55
M-56
M-57
M-58

M-59

M-60

M-61
M-62

M-63
M-64
M-65
M-66

M-67
M-68
M-69
M-70
M-71
M-72
M-73
M-74
M-75

M-76

M-77

TREATMENT IN ADULTS WITH GROWTH HORMONE DEFICIENCY

PROVISION OF RESULTS OF STUDY AND PROPOSED REVISIONS TO PACKAGE INSERT SEE SECTION
ON CARDIAC ELECTROPHYSIOLOGY
PROVIDES FOR USE OF ANTARA WITHOUT REGARD TO MEALS
CHANGES TO THE LABELING DESCRIBING THE RESULTS OF A STUDY OF THE USE OF NOVOLOG
MIX 70/30 WITH ORAL ANTIDIABETIC AGENTS IN PATIENTS WITH TYPE 2 DIABETES
CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING EFFECT OF
SINGULAIR ON GROWTH RATES IN PREPUBERTAL CHILDREN
NEW INFO TO THE CLINICAL STUDIES, ADULT GROWTH HORMONE DEFICIENCY (GHD) SUBSECTION
OF THE NUTROPIN AQ PACKAGE INSERT DESCRIBING THE EFFECTS OF SOMATROPIN ON VISCERAL
ADIPOSE TISSUE IN THE ADULT GROWTH HORMONE DEFICIENT PATIENT POPULATION
INFORMATION ADDED TO LABELING REGARDING OSTEOGENESIS IMPERFECTA STUDY
INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY/CLINICAL STUDIES SECTION REGARDING
THE USE OF RISEDRONATE ADMINISTERED ONCE A WEEK IN THE PREVENTION OF OSTEOPOROSIS
IN POSTMENOPAUSAL WOMEN
FOR LABELING CHANGES TO THE QUALITY OF LIFE (QOL) STATEMENT IN THE APPROVED
PACKAGE INSERT
INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
INFORMATION ON RESULTS OF A STUDY OF THE USE OF SANDOSTATIN LAR DEPOT IN PEDIATRIC
PATIENTS WITH HYPOTHALAMIC OBESITY.
INFORMATION ADDED TO CLINICAL TRIAL SECTION WITH INFORMATION ON "GEMINI" TRIAL
CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING THE
PHARMACOKINETICS OF EZETIMIBE IN ASIAN SUBJECTS
CHANGES TO THE CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, VYTORIN SUBSECTION
OF THE PACKAGE INSERT TO ADD EFFICACY DATA FOR THE EZETIMIBE/SIMVASTATIN
COMBINATION PRODUCT AND FOR AN ATORVASTATIN PRODUCT ON LDL-C AND OTHER LIPID
PRMTRS
RESULTS OF THE T20-310 STUDY WHICH EVALUATED THE PHARMACOKINETICS, SAFETY, AND
ANTIVIRAL ACTIVITY OF FUZEON IN TREATMENT EXPERIENCED PEDIATRIC SUBJECTS AND
ADOLSCENTS WAS ADDED TO THE PEDIATRIC SUBSECTION OF PRECAUTIONS
CHANGES TO CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, TO ADD EFFICACY DATA
FOR THE EZETIMIBE/SIMVASTATIN COMBINATION PRODUCT AND FOR A ROSUVASTATIN PRODUCT
ON LDL-C AND OTHER LIPID PARAMETERS IN PATIENTS WTH HYPERCHOLESTEROLEMIA
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN
REQUEST
CLINICAL INFORMATION FROM ONE CLINICAL STUDY INVESTIGATING THE USE OF AVANDAMET
PLUS INSULIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE NOT ACHIEVED
ADEQUATE GLYCEMIC CONTROL WITH PREVIOUS ANTI-DIABETIC THERAPIES
DETAILED INFORMATION ON AN INCONCLUSIVE PEDIATRIC STUDY
CHANGES TO CLINICAL PHARMACOLOGY DETAILING STUDY RESULTS
ADDITION OF INFORMATION TO LABEL TO INCLUDE INFORMATION REGARDING USE IN PATIENTS
WITH HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME (HARS)
USE IN SPECIFIC POPULATIONS - PATIENTS WITH CONCOMITANT ILLNESS SUBSECTION OF THE
LABELING REGARDING USE OF STRATTERA IN PATIENTS WITH ADHD WHO HAVE COMORBID TIC
DISORDER
INDICATION EXPANDED TO INCLUDE PATIENTS ON PERITONEAL DIALYSIS
DESCRIPTION OF RESULTS OF STUDY OF INITIAL THERAPY IN COMBINATION WITH METFORMIN
WHEN DIET AND EXERCISE DO NOT PROVIDE GLYCEMIC CONTROL
RESULTS OF STUDY OF COMBINATION THERAPY AND NON-INFERIORITY STUDY
PROVISION OF INFORMATION OF THE RESULTS OF A PHASE 2 RANDOMIZED TRIAL OF SPRYCEL
70MG TWICE DAILY OR IMATINIB 800MG DAILY
REVISIONS TO PROVIDE FOR RESULTS OF MAINTENANCE DATA IN ADULT PATIENTS WITH MAJOR
DEPRESSIVE DISORDER
INFORMATION ABOUT USE OF INSPRA (EPLERENONE) FOR HYPERTENSION IN PEDIATRIC
PATIENTS
NEW INFORMATION ADDED REGARDING THE TUMOR SHRINKING POTENTIAL OF SANDOSTATIN LAR
DEPOT INJECTION ON GH - SECRETING PITUITARY ADENOMAS
REVISIONS TO CLINICAL STUDIES - CHILDREN AND ADOLSCENTS BASED ON CLINICAL TRIAL
DATA TO SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS
PROVISION FOR USE OF ARGAGATROBAN IN CERTAIN PEDIATRIC PATIENTS WITH HEPARININDUCED THROMBOCYTOPENIA (HIT) OR HEPARIN-INDUCED THROMBOCYTOPENIA WITH THROMBOSIS
(HITTS)
REMOVAL OF SCREEN REQUIREMENT IN PTS WITH G6PD DEFICIENCY PRIOR TO INITIATING
ACZONE TREATMENT; REMOVAL OF BLOOD COUNT & RETICULOCYTE MONITORING DURING
TREATMENT IN G6PD DEFICIENT PTS AND IN PATIENTS WITH HISTORY OF ANEMIA
USE IN COMBINATION WITH THE NEW AKTILITE CL128 LAMP FOR THE TREATMENT OF THIN AND
MODERATELY THICK, NON-HYPERKERATOTIC, NON-PIGMENTED ACTINIC KERATOSES OF THE FACE
AND SCALP IN IMMUNOCOMPETENT PATIENTS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 26 of 73

EXCLUSIVITY MISCELLANEOUS
M-78

M-79
M-80
M-81

M-82
M-83
M-84
M-85
M-86

M-87
M-88
M-89

M-90

M-91

M-92

M-93

M-94
M-95
M-96

M-97
M-98

M-99

M-100
M-101
M-102

M-103

M-104
M-105

M-106

CLINICAL TRIAL INFO ON USE OF STRATTERA IN PATIENTS WITH ATTENTION DEFICIT

HYPERACTIVITY DISORDER (ADHD) AND COMORBID ANXIETY DISORDER WITHOUT CAUSING
WORSENING OF ANXIETY
LABELING REVISIONS RELATED TO SMOKING AND ERLOTIMB EXPOSURE
ADDITIONAL TIME POINT OF 30 MINUTES (0.5 HOUR) IN CHILDREN AGED 6-12 YEARS WITH A
DIAGNOSIS OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD)
ADDITIONAL INFO FOR PEDIATRIC USE FOR CASODEX (STUDIED IN COMBINATION WITH
ARIMIDEX) IN THE PEDIATRIC POPULATION, SPECIFICALLY BOYS WITH FAMILIAL MALELIMITED PRECOCIOUS PUBERTY (TESTOXICOSIS)
LABELING REVISIONS RELATED TO CLINICAL STUDIES
ADDITIONAL INFORMATION ADDED TO LABELING REGARDING ESTABLISHMENT OF EFFICACY IN
ADDITIONAL CLINICAL TRIALS AND ONE MAINTENANCE TRIAL
STUDY INFORMATION ADDED TO LABEL REGARDING BONE MINERAL DENSITY
INFORMATION ADDED TO LABELING REGARDING USE OF PREVACID IN PATIENTS LESS THAN 1
YEAR WITH SYMPTOMATIC GERD
LABELING CHANGES SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST FOR INFANTS
AGES BIRTH TO 11 MONTH INCLUSIVE REFLECTING LACK OF EFFICACY FOR GERD INDICATION
FOR THIS PATIENT POPULATION
INCLUSION OF RESULTS FROM TWO DRUG INTERACTION STUDIES WITH LIPITOR AND CRESTOR IN
CLINICAL PHARMACOLOGY SECTION
ADDITION OF INFORMATION REGARDING ABUSE POTENTIAL OF CONCERTA VERSUS IMMEDIATERELEASE METHYLPHENIDATE
PROVIDES FOR REVISIONS TO MULTIPLE SECTIONS OF THE PACKAGE INSERT TO REFLECT
RESULTS OF CLINICAL TRIALS 205.235 (UPLIFT) AND 205.266 (VA STUDY) IN SUPPORT OF
EXACERBATION CLAIM
LABELING CHANGES BASED ON DATA FROM CLINICAL STUDIES NV20235 AND NV20236 STUDIES
OF SEASONAL PROPHYLAXIS OF INFLUENZA IN IMMUNOCOMPROMISED PATIENTS AND CHILDREN
AGES 1-12
UPDATED LABELING BASED UPON STUDY: A SINGLE-DOSE, SINGLE-BLIND, PLACEBO-AND
MOXIFLOXACIN-CONTROLLED 2-PERIOD, RANDOMIZED, CROSSOVER, 3RD PERIOD SEQUENTIAL
STUDY OF SIDE EFFECTS OF TEMSIROLIMUS ON CARDIAC REPOLARIZATION IN HEALTHY
SUBJECTS
UPDATES TO THE PACKAGE INSERT BASED UPON THE TRIAL ENTITLED "A PHASE I
PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF TEMSIROLIMUS IN PATIENTS WITH
ADVANCED MALIGNANCIES AND NORMAL AND IMPAIRED LIVER FUNCTION
EXPANSION OF LABELING TO INCLUDE INFORMATION ON SAFETY AND EFFICACY OF CREON IN
PATIENTS AGES 7 YEARS THROUGH 11 YEARS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE
TO CYSTIC FIBROSIS
INFO ADDED TO LABEL RELATED TO NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE
(PH+) CHRONIC MYELOID LEUKEMIA IC CHRONIC PHASE
INFORMATION FOR TREATMENT OF CHRONIC HEPATITIS B (CHB) IN ADULT PATIENTS WITH
DECOMPENSATED LIVER DISEASE BASED ON DATA FROM CLINICAL TRIAL GS-US-174-0108
UPDATED INFORMATION IN THE CLINICAL STUDIES SECTION RELATED TO THE LOSS AND
RECOVERY OF BONE MINERAL DENSITY IN ADOLESCENT GIRLS DURING AND FOLLOWING THE USE
OF DEPO-PROVERA CONTRACEPTIVE INJECTION
LABELING CHANGES IN RESPONSE TO PEDIATRIC STUDIES - NOT INDICATED FOR USE IN
PEDIATRIC POPULATION
NEW INFORMATION FROM A STUDY WHICH EVALUATED THE SAFETY AND EFFICACY OF FAMVIR IN
TREATING RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT BLACK/AFRICAN AMERICAN
SUBJECTS.
ADDITION OF FINDINGS FROM A SINGLE PEDIATRIC CLINICAL TRIAL (P04292) OF NASONEX
NASAL SPRAY IN THE TREATMENT OF NASAL POLYPS IN PATENTS 6 TO <18 YEARS OF AGE TO
THE PACKAGE INSERT.
INFORMATION ADDED TO LABEL BASED UPON COMPLETED CLINICAL TRIAL REPORTS
INCLUSION OF DATA FROM AN ADDITIONAL 19 SUBJECTS WITH HYPERCALCEMIA FROM
PARATHYROID CARCINOMA TO THE INFORMATION CURRENTLY PRESENTED IN THE LABEL
INFORMATION FROM PEDIATRIC STUDY REPORT ML16633, "INTRAVENOUS GRANISETRON (KYTRIL)
IN THE PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING (PONV) IN PEDIATRIC
SUBJECTS UNDERGOING TONSILLECTOMY OR ADENOTONSILLECTOMY."
SAFETY, EFFICACY AND PHARMACOKINETIC INFO FOR FASLODEX IN THE PEDIATRIC
POPULATION, SPECIFICALLY FOR GIRLS WITH PROGRESSIVE PRECOCIOUS PUBERTY ASSOCIATED
WITH MCCUNE-ALBRIGHT SYNDROME ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING
INFORMATION ADDED TO DOSING AND ADMINISTRATION REGARDING A 26 WEEK STUDY
NEW LANGUAGE ADDED TO CLINICAL STUDIES REGARDING USE IN SMOKERS WITH
CARDIOVASCULAR DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND USE ACCORDING
TO AN ALTERNATIVE SET OF DIRECTIONS FOR SETTING A QUIT DATE
ADDITION OF THE T1-WEIGHTED GD-ENHANCED LESION EFFICACY VARIABLE IN THE CLINICAL
STUDIES SECTION 14 OF THE PACKAGE INSERT

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 27 of 73

EXCLUSIVITY MISCELLANEOUS
M-107

M-108
M-109
M-110
M-111

M-112

M-113

M-114
M-115

M-116
M-117
M-118
M-119
M-120
M-121
M-122
M-123
M-124

M-125
M-126
M-127
M-128
M-129
M-130
M-131
M-132
M-133
M-134
M-135
M-136

M-137
M-138
M-139
M-140

M-141

INFORMATION TO THE CLINICAL STUDIES SECTION OF THE LUPRON DEPOT-PED,1-MONTH,BASED

UPON THE PHASE 3/4 COMPLETED CLINICAL STUDY REPORT FOR STUDY M90-516, ENTITLED
"STUDY OF LUPRON DEPOT IN THE TREATMENT OF CENTRAL PRECOCIOUS PUBERTY".
CHANGES ARE BASED ON RESULTS FROM STUDY CV181057
CHANGES TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF THE STUDY OF HEART AND
RENAL PROTECTION (SHARP) TRIAL
CHANGES TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF THE STUDY OF HEART AND
RENAL PROTECTION (SHARP) TRIAL
LABELING CHANGES BASED ON STUDY HW80-EW-GWCI ENTITLED A PLACEBO AND POSITIVE
CONTROLLED STUDY OF THE ELECTROPHYSIOLOGICAL EFFECTS OF A SINGLE 10 MCG DOSE OF
EXENATIDE ON THE 12 LEAD ELECTROCARDIOGRAM QT INTERVAL IN HEALTHY SUBJECTS
REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO ADD INFORMATION
FROM A PEDIATRIC STUDY IN PATIENTS AGED 12 YEARS TO LESS THAN 18 YEARS OF AGE WITH
RECURRENT HERPES LABIALIS
LABELING CHANGES BASED ON STUDY H80-US-GWCO ENTITLED A RANDOMIZED TRIAL COMPARING
EXENATIDE WITH PLACEBO IN SUBJECTS WITH TYPE 2 DIABETES ON INSULIN GLARGINE WITH
OR WITHOUT ORAL ANTIHYPERGLYCEMIC MEDICATIONS
CHANGES IN SECTION 14 OF THE PACKAGE INSERT TO INCLUDE DATA FROM THE SWITCHMRK
STUDIES (SWITCH OF SUPPRESSED SUBJECTS FROM LOPINAVIR/RITONAVIR TO RALTEGRAVIR)
REVISIONS TO THE PI BASED ON RESULTS FROM STUDY NN2211-1842, ENTITLED THE EFFECT
OF INSULIN DETEMIR IN COMBINATION WITH LIRAGLUTIDE AND METFORMIN COMPARED TO
LIRAGLUTIDE AND METFORMIN IN SUBJECTS WITH TYPE 2 DIABETES
LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY 01-06-TL-OPIMET-008
ADDITION OF RESULTS OF PEDIATRIC TRIAL TO LABEL
LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.36
LABELING CHANGES REGARDING MISSED DOSES
CHANGES TO CLINICAL TRIALS DETAILING STUDY RESULTS
LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.43
LABELING CHANGES TO INCLUDE THE RESULTS OF THE PARAMOUNT TRIAL
UPDATED RESULTS OF OVERALL SURVIVAL FROM 'CONFIRM' STUDY
LONG TERM SAFETY AND EFFICACY DATA FROM STUDY CLDT600A2303 FOR SUBJECTS PREVIOUSLY
ENROLLED IN THE ORIGINAL TWO YEAR GLOBE (NV-02B-007/CLDT600A2302) AND NV02B-015
STUDIES WHO CONTINUED TELBIVUDINE TREATMENT FOR UP TO 208 WEEKS
LABELING CHANGES TO INCLUDE LACK OF EFFICACY IN CHILDREN 6 MONTHS TO 4 YEARS OF
AGE
UPDATES TO THE CLINICAL STUDIES SECTION 14, OF THE PACKAGE INSERT (PI), WITH THE
RESULTS OF CLINICAL TRIAL P06086
REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO REFLECT THE
RESULTS FROM CLINICAL STUDY C-10-004
CLINICAL TRIAL STUDY RESULTS
RESULTS OF A CLINICAL STUDY REPORT WHICH ASSESSES THE SAFETY AND EFFICACY IN
CHILDREN AGES 6 TO 12 YEARS OF AGE
ADDITION OF INFORMATION ON LONG-TERM TREATMENT WITH VPRIV IN THE CLINICAL TRIALS
SECTION OF THE PACKAGE INSERT
INFORMATION FROM STUDIES CONDUCTED IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED NONDISSEMINATED DIFFUSED INTRINSIC BRAINSTEM GLIOMAS
REVISIONS TO THE CLINICAL TRIALS SECTION IN THE INOMAX LABEL TO REFLECT RESULTS
FROM THE PEDIATRIC STUDY REPORTS
INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF SILDENAFIL TO BOSENTAN
THERAPY
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED WITH SAXAGLIPTIN IN
COMBINATION WITH METFORMIN AND A SULFONYLUREA ADDED TO THE LABELING
ADDITION OF INFORMATION TO THE CLINICAL STUDIES - RADIOGRAPHIC RESPONSE SECTION OF
THE PACKAGE INSERT
ADDITIONAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE
LABELING REGARDING POST-OPERATIVE NAUSEA AND VOMITING STUDIES IN PEDIATRIC
PATIENTS
LABELING REVISIONS RESULTING FROM A MAINTENANCE TRIAL IN PEDIATRIC PATIENTS WITH
IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
INFORMATION ADDED TO THE 8.4 PEDIATRIC USE SECTION ON THE USE OF MEMANTINE IN
CHILDREN AGES 6-12 YEARS WITH AUTISM SPECTRUM DISORDER
INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE PACKAGE INSERT
REGARDING RETREATMENT WITH VELCADE FOR PATIENTS WITH MULTIPLE MYELOMA
INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING USE OF
LATISSE IN PATIENTS WHO WERE POST-CHEMOTHERAPY OR HAD ALOPECIA AREATA, AND
ADOLESCENTS WHO HAD HYPERTRICHOSIS WITH NO ASSOCIATED MEDICAL CONDITION
REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING TO INCORPORATE STUDY

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 28 of 73

EXCLUSIVITY MISCELLANEOUS

M-142
M-143

M-144
M-145
M-146

M-147
M-148
M-149
M-150
M-151
M-152

M-153
M-154
M-155

M-156
M-157

M-158
M-159

M-160

M-161

M-162
M-163
M-164

M-165

M-166

M-167

M-168

RESULTS FOR TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADOLESCENTS (AGES 12-17)

ADDITIONS TO THE LABELING DESCRIBING RESULTS FROM STUDY H6P-MC-HDAY
INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF VARENICLINE
FOR SMOKING CESSATION IN PATIENTS WITH CURRENT OR PAST HISTORY OF MAJOR DEPRESSIVE
DISORDER
INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF VARENICLINE
FOR SMOKING CESSATION IN PATIENTS WHO HAD BEEN PREVIOUSLY TREATED WITH VARENICLINE
ADDITION OF INFORMATION ABOUT LONG-TERM TREATMENT OF PULMONARY ARTERIAL
HYPERTENSION TO THE CLINICAL STUDIES SECTION OF THE LABELING
INFORMATION ADDED TO THE CLINICAL STUDIES SECTION ON INITIAL COMBINATION THERAPY
WITH LINAGLIPTIN AND METFORMIN VS. LINAGLIPTIN MONOTHERAPY IN TREATMENT NAIVE
PATIENTS
OTC USE FOR TEMPORARY RELIEF OF OCULAR SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER
RESPIRATORY ALLERGIES
LABELING CHANGES BASED ON STUDY H80-EW-GWDM
INFORMATION ADDED TO THE LABELING REGARDING MAINTENANCE MONOTHERAPY FOR ADHD
ADDITION OF THE RESULTS OF A CONTROLLED CLINICAL STUDY TREATING ADULT PATIENTS
WITH SCHIZOPHRENIA EXPERIENCING AN ACUTE RELAPSE
REVISIONS TO THE LABELING BASED ON THE OUTCOMES OF PEDIATRIC STUDIES CONDUCTED TO
ASSESS THE SAFETY AND EFFICACY OF XOPENEX IN SUBJECTS LESS THAN 6 YEARS OF AGE
INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION OF THE LABELING REGARDING A
SAFETY STUDY IN PEDIATRIC SUBJECTS AGES 6 MONTHS TO 4 YEARS OF AGE WITH AN ACTIVE
HEAD LICE INFESTATION
ADDITION OF INFORMATION REGARDING THE INTRANASAL ABUSE POTENTIAL OF OXYCONTIN
UPDATE TO THE LABELING TO REFLECT THE RESULTS OF A LONG-TERM MAINTENANCE TREATMENT
STUDY OF ADHD IN CHILDREN AND ADOLESCENTS AGES 6-17.
ADDITION OF CLINICAL FINDINGS FROM AN OBSERVATIONAL STUDY IN A PEDIATRIC AGE GROUP
GREATER THAN 2 MONTHS TO 18 YEARS IN SECTION 8.4 PEDIATRIC USE OF THE PACKAGE
INSERT
UPDATE TO THE LABELING WITH INFORMATION REGARDING A CLINICAL TRIAL IN CHILDREN
LESS THAN 4 YEARS OF AGE.
INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF
DAPAGLITFLOZIN 10MG ONCE DAILY IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE
INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND
SULFONYLUREA
UPDATES TO THE LABELING TO REFLECT SAFETY RESULTS FROM CLINICAL TRIALS IN
SCHIZOPHRENIA ADOLESCENT PATIENTS AGED 12 TO 17 YEARS
ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF
BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (>
THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND ACTIVE-CONTROLLED STUDY
COMPARING EMPAGLIFLOZIN TO GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES AND
INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN TREATMENT
UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED
STUDY OF EMPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT
GLYCEMIC CONTROL ON A MULTIPLE DAILY INJECTION INSULIN REGIMEN ALONE OR WITH
METFORMIN
INCLUSION OF EFFICACY AND SAFETY DATA TO THE PRESCRIBING INFORMATION OF BYDUREON
BASED ON STUDY GWDE
INFORMATION ADDED TO THE LABELING REGARDING PREVIOUSLY UNTREATED ALK-POSITIVE
METASTATIC NON SMALL CELL LUNG CANCER (NSCLC)
REVISES THE CLINICAL TRIALS SECTION OF THE PRESCRIBING INFORMATION TO INCORPORATE
THE RESULTS FROM STUDY E7273-G000-401 ENTITLED "PHASE IV RANDOMIZED STUDY OF TWO
DOSE LEVELS OF TARGRETIN CAPSULES IN SUBJECTS WITH REFRACTORY CUTANEOUS T-CELL
LYMPHOMA"
PROVIDES FOR UPDATES TO THE PEDIATRIC USE SECTION BASED ON THE PEDIATRIC STUDY
REPORT ENTITLED, "A PHASE II PILOT TRIAL OF BORTEZOMIB IN COMBINATION WITH
INTENSIVE RE-INDUCTION THERAPY IN CHILDREN WITH RELAPSED ACUTE LYMPHOBLASTIC
LYMPHOMA (LL)"
UPDATE TO LABELING WITH WEEK 48 RESULTS FROM VIKING-4 IN ANTIRETROVIRAL THERAPY
(ART) - EXPERIENCED INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) - RESISTANT
SUBJECTS
APPROVED FOR REVISIONS TO THE LABELING BASED ON THE CLINICAL STUDY ENTITLED
"BRONCHOPULMONARY DYSPLASIA (BPD) IN PRETERM INFANTS REQUIRING MECHANICAL
VENTILATION OR POSITIVE PRESSURE SUPPORT ON DAYS 5 TO 14 AFTER BIRTH".
INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE
RE-NOVATE AND RE-NOVATE LL STUDIES (PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND
PULMONARY EMBOLISM FOLLOWING HIP REPLACEMENT SURGERY)

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 29 of 73

EXCLUSIVITY MISCELLANEOUS
M-169

UPDATES TO LABELING DESCRIBING RESPONSE TO A REPEAT COURSE OF PICATO GEL 0.015% ON

THE FACE OR SCALP IF AN INCOMPLETE RESPONSE IS OBSERVED AT A FOLLOW-UP
EXAMINATION.
PATENT USE

U-1
U-2
U-3
U-4
U-5
U-6
U-7
U-8
U-9
U-10
U-11
U-12
U-13
U-14
U-15
U-16
U-17
U-18
U-19
U-20
U-21
U-22

U-23
U-24
U-25
U-26
U-27
U-28
U-29
U-30
U-31
U-32
U-33
U-34
U-35
U-36
U-37
U-38
U-39
U-40
U-41
U-42
U-43
U-44
U-45
U-46
U-47
U-48

PREVENTION OF PREGNANCY
TREATMENT OR PROPHYLAXIS OF ANGINA PECTORIS AND ARRHYTHMIA
TREATMENT OF HYPERTENSION
PROVIDING PREVENTION AND TREATMENT OF EMESIS AND NAUSEA IN MAMMALS
METHOD OF PRODUCING BRONCHODILATION
METHOD OF PRODUCING SYMPATHOMIMETIC EFFECTS
INCREASING CARDIAC CONTRACTILITY
ACUTE MYOCARDIAL INFARCTION
CONTROL OF EMESIS ASSOCIATED WITH ANY CANCER CHEMOTHERAPY AGENT
DIAGNOSTIC METHOD FOR DISTINGUISHING BETWEEN HYPOTHALMIC MALFUNCTIONS OR LESIONS
IN HUMANS
TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS
METHOD OF TREATING [A] HUMAN SUFFERING FROM DEPRESSION
A METHOD FOR TREATING ANXIETY IN A HUMAN SUBJECT IN NEED OF SUCH TREATMENT
ADJUNCTIVE THERAPY FOR THE PREVENTION AND TREATMENT OF HYPERAMMONEMIA IN THE
CHRONIC MANAGEMENT OF PATIENTS WITH UREA CYCLE ENZYMOPATHIES
METHOD OF LOWERING INTRAOCULAR PRESSURE
USE IN LUNG SCANNING PROCEDURES
TREATMENT OF VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS
METHOD FOR INHIBITING GASTRIC SECRETION IN MAMMALS
TREATMENT OF INFLAMMATION
A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED
OF TREATMENT
TREATMENT OF HUMANS SUFFERING UNDESIRED UROTOXIC SIDE EFFECTS CAUSED BY
CYTOSTATICALLY ACTIVE ALKYLATING AGENTS
METHOD OF COMBATTING PATHOLOGICALLY REDUCED CEREBRAL FUNCTIONS AND PERFORMANCE
WEAKNESSES, CEREBRAL INSUFFICIENCY AND DISORDERS IN CEREBRAL CIRCULATION AND
METABOLISM IN WARM-BLOODED ANIMALS
METHOD FOR TREATING PROSTATIC CARCINOMA COMPRISING ADMINISTERING FLUTAMIDE
METHOD FOR TREATING PROSTATE ADENOCARCINOMA COMPRISING ADMINISTERING AN
ANTIANDROGEN INCLUDING FLUTAMIDE AND AN LHRH AGONIST
REDUCING CHOLESTEROL IN CHOLELITHIASIS PATIENTS
REDUCING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
DISSOLVING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
CEREBRAL, CORONARY, PERIPHERAL, VISCERAL AND RENAL ARTERIOGRAPHY, AORTOGRAPHY AND
LEFT VENTRICULOGRAPHY
CT IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY
CEREBRAL ANGIOGRAPHY, AND VENOGRAPHY
INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY
PALLIATIVE TREATMENT OF PATIENTS WITH OVARIAN CARCINOMA RECURRENT AFTER PRIOR
CHEMOTHERAPY, INCLUDING PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED WITH CISPLATIN
TREATING VIRAL INFECTIONS IN A MAMMAL
TREATING VIRAL INFECTIONS IN A WARM-BLOODED ANIMAL
TREATING CYTOMEGALOVIRUS IN A HUMAN WITH AN INJECTABLE COMPOSITION
METHODS OF TREATING BACTERIAL ILLNESSES
METHOD OF TREATING GASTROINTESTINAL DISEASE
TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA
ANGINA PECTORIS
METHOD OF TREATMENT OF BURNS
METHOD OF TREATING CARDIAC ARRHYTHMIAS
ADJUVANT TREATMENT IN COMBINATION WITH FLUOROURACIL AFTER SURGICAL RESECTION IN
PATIENTS WITH DUKES' STAGE C COLON CANCER
MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
RELIEF OF NAUSEA AND VOMITING
TREATMENT OF INFLAMMATION AND ANALGESIA
TREATMENT OF PANIC DISORDER
STIMULATION OF THE RELEASE OF GROWTH HORMONE
ANALGESIA

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 30 of 73

PATENT USE
U-49
U-50
U-51
U-52
U-53
U-54
U-55
U-56
U-57
U-58
U-59
U-60
U-61
U-62
U-63
U-64
U-65
U-66
U-67
U-68
U-69
U-70
U-71
U-72
U-73
U-74
U-75
U-76
U-77
U-78
U-79
U-80
U-81
U-82
U-83
U-84
U-85
U-86
U-87
U-88
U-89
U-90
U-91
U-92
U-93
U-94

U-95
U-96
U-97
U-98
U-99
U-100
U-101
U-102
U-103

SYMPTOMATIC CANCER-RELATED HYPERCALCEMIA

USE IN TREATING INFLAMMATORY DERMATOSES
BLOOD POOL IMAGING, INCLUDING CARDIAC FIRST PASS AND GATED EQUILIBRIUM IMAGING AND
FOR DETECTION OF SITES OF GASTROINTESTINAL BLEEDING
TREATMENT OF ADULT AND PEDIATRIC PATIENTS(OVER SIX MONTHS OF AGE) WITH ADVANCED
HIV INFECTION
HYPERCALCEMIA OF MALIGNANCY
REVERSAL AGENT OR ANTAGONIST OF NONDEPOLARIZING NEUROMUSCULAR BLOCKING AGENTS
TREATMENT OF PAIN
AID TO SMOKING CESSATION
OPHTHALMIC USE OF NORFLOXACIN
METHOD OF TREATING INFLAMMATORY INTESTINAL DISEASES
METHOD OF TREATING HYPERCHOLESTEROLEMIA
NASAL ADMINISTRATION OF BUTORPHANOL
CEREBRAL AND PERIPHERAL ARTERIOGRAPHY AND CT IMAGING OF THE HEAD
CORONARY ARTERIOGRAPHY, LEFT VENTRICULOGRAPHY, CT IMAGING OF THE BODY, INTRAVENOUS
EXCRETORY UROGRAPHY, INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY AND VENOGRAPHY
ISOPRENALINE ANTAGONISM ON THE HEART RATE OR BLOOD PRESSURE
TREATMENT OF VIRAL INFECTIONS
METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV
TRIPHASIC REGIMEN
METHOD OF INDUCING ANESTHESIA IN A WARM BLOODED ANIMAL
TREATMENT OF ACTINIC KERATOSIS
TREATMENT OF PNEUMOCYSTIS CARINII INFECTIONS
TREATMENT OF TRANSIENT INSOMNIA
METHOD OF TREATMENT OF HEART FAILURE
TREATMENT OF MIGRAINE
METHOD OF TREATING DISEASES OR INFECTIONS CAUSED BY MYCETES
METHOD OF PROVIDING HYPNOTIC EFFECT
RELIEF OF OCULAR ITCHING DUE TO SEASONAL ALLERGIC CONJUNCTIVITIS
USE TO IMAGE A SUBJECT WITH A MAGNETIC RESONANCE IMAGING SYSTEM
TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
ULCERATIVE COLITIS
SYMPTOMATIC TREATMENT OF PATIENTS WITH NOCTURNAL HEARTBURNDUE TO GERD
METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
TREATMENT FOR DEMENTIA IN PATIENTS WITH ALZHEIMER'S DISEASE
TREATMENT OF SEIZURES
A METHOD OF BLOCKING THE UPTAKE OF MONOAMINES BY BRAIN NEURONS IN ANIMALS
NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
METHOD OF TREATING CERTAIN FORMS OF EPILEPSY
METHOD FOR NONINVASIVE ADMINISTRATION OF SEDATIVES, ANALGESICS, AND ANESTHETICS
TREATMENT OF MODERATE PLAQUE PSORIASIS
TREATMENT OR PROPHYLAXIS OF EMESIS
TREATMENT OF PYSCHOTIC DISORDERS
ALTERNATIVE THERAPY TO TRIMETHOPRIM-SULFAMETHOXAZOLE FOR TREATMENT OF MODERATE-TOSEVERE PNEUMOCYSTIS CARINII PNEUMONIA IN IMMUNOCOMPROMISED AND AIDS PATIENTS
TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN DEPENDENT
DIABETES MELLITUS AND RETINOPATY
USE AS AN ANTIHISTAMINE/DECONGESTANT
TREATMENT-ADULTS W/ ADVANCED HIV,INTOLERANT OF APPROVED THERAPIES,INTOLERANT OF
APPROVED THERAPIES W/PROVEN BENEFIT OR HAVE EXPERIENCED CLINICAL/IMMUNOLOGICAL
DETERIORATION WHILE RECEIVING..OR FOR WHOM SUCH THERAPIES-CONTRAINDICATED
SHORT TERM MANAGEMENT OF MODERATE PRURITIS IN ADULTS WITH ATOPIC DERMATITIS AND
LICHEN SIMPLEX CHRONICUS
METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
A METHOD OF TREATING A PATIENT IN NEED OF MEMORY ENHANCEMENT
A METHOD OF INDUCING REGRESSION OF LEUKEMIA CELL GROWTH IN A MAMMAL
METHOD OF PROVIDING POTASSIUM TO A SUBJECT IN NEED OF POTASSIUM
METHOD OF TREATING OCULAR INFLAMMATION
ADJUNCT TO CONVENTIONAL CT OR MRI IMAGING IN THE LOCALIZATION OF STROKE IN
PATIENTS IN WHOM STROKE HAS ALREADY BEEN DIAGNOSED
METHOD OF HORMONALLY TREATING MENOPAUSAL OR POST-MENOPAUSAL DISORDERS IN WOMEN
TREATMENT OF OCULAR HYPERTENSION

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 31 of 73

PATENT USE
U-104
U-105
U-106
U-107
U-108

U-109

U-110
U-111
U-112
U-113
U-114
U-115
U-116
U-117
U-118
U-119
U-120
U-121
U-122
U-123
U-124
U-125
U-126
U-127
U-128
U-129
U-130
U-131
U-132
U-133
U-134
U-135
U-136
U-137
U-138
U-139
U-140
U-141
U-142
U-143
U-144
U-145
U-146
U-147
U-148
U-149
U-150
U-151
U-152

TREATMENT OF AQUEOUS HUMOR FORMATION AND INTRAOCULAR PRESSURE

EMESIS
TREATMENT OF EPILEPSY
TREATMENT OF HYPERTENSION AND ANGINA PECTORIS
SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER, GASTROESOPHAGEAL REFLUX DISEASE
(GERD), SEVERE EROSIVE ESOPHAGITIS, POORLY RESPONSIVE SYMPTOMATIC GERD AND
PATHOLOGIAL HYPERSECRETORY CONDITIONS AND MAINTENANCE HEALING OF EROSIVE
ESOPHAGITIS
ADJUNCT DIET IN THE TX OF ELEVATED TOTAL CHOLESTEROL AND LDL-C LEVELS IN PTS
W/PRIMARY HYPERCHOLESTEROLEMIA WHOSE RESPONSE TO DIETARY RESTRICTION OF SAT FAT
AND CHOLESTEROL AND OTHER NONPHARMACOLOGICAL MEASURES HAS NOT BEEN ADEQUATE
USE AS A RETRIEVABLE PERSSARY
DIABETES
CONTRACEPTION
METHOD OF CONDUCTING RADIOLOGICAL EXAMINATION OF A PATIENT BY ADMINISTERING TO
SAID PATIENT A RADIOPAQUE AMOUNT OF IOPROMIDE
USE FOR INHIBITING BONE RESORPTION
USE OF VASODILATORS TO EFFECT AND ENHANCE AN ERECTION (AND THUS TREAT ERECTILE
DYSFUNCTION), BY INJECTION INTO THE PENIS
METHOD OF MYOCARDIAL IMAGING
TREATMENT OF OCULAR ALLERGIC RESPONSE IN HUMAN EYES
METHOD OF LOWERING BLOOD SUGAR LEVEL
TREATMENT OF NASAL HYPERSECRETION
CONTROLLING OR PREVENTING POST-OPERATIVE INTRAOCULAR PRESSURE RISES ASSOCIATED
WITH OPHTHALMIC LASER SURGICAL PROCEDURES
METHOD OF TREATING CONDITIONS MEDIATED THROUGH HISTAMINE H2-RECEPTORS
A THERAPEUTIC METHOD FOR CONTROLLING THROMBOSIS
METHOD FOR CONTROLLING THROMBOSIS AND DECREASING BLOOD HYPERCOAGULATION AND
HEMORRHAGING RISKS
TREATMENT OF ACNE
TREATMENT NEUROGENERATIVE DISEASES
TREATMENT OF GASTRITIS
METHOD OF PRODUCING NEUROMUSCULAR BLOCKADE
METHOD FOR TREATMENT OF TUMORS
METHOD TO DESTROY OR IMPAIR TARGET CELLS
MANAGEMENT OF PATIENTS WITH MASTOCYTOSIS
PHOTODAMAGED SKIN
INHIBITING HIV PROTEASE
MANAGEMENT OF OBESITY INCLUDING WEIGHT LOSS AND MAINTENANCE IN PATIENTS ON A
REDUCED-CALORIE DIET
TREATMENT OF ACNE VULGARIS
ANTITUMOR AGENT
PROCESS FOR WASTE NITROGEN REMOVAL
METHOD OF TREATING BACTERIAL VAGINOSIS
TREATMENT OF ALLERGIC RHINITIS
TREATMENT OF ALLERGIC REACTIONS
USE OF NORVIR TO INHIBIT HIV PROTEASE OR TO INHIBIT AN HIV INFECTION
TREATMENT OF ULCERATIVE COLITIS
METHOD OF TREATING ALLERGIC REACTIONS IN A MAMMAL BY USING THIS ACTIVE METABOLITE
BIODEGRADABLE SUPERPARAMAGNETIC METAL OXIDES AS CONTRAST AGENTS FOR MR IMAGING
BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC MATERIALS FOR USE IN CLINICAL
APPLICATIONS
BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC PARTICLES FOR USE AS NUCLEAR MAGNETIC
RESONANCE IMAGING AGENTS
METHOD OF TREATING SUSCEPTIBLE NEOPLASMS IN MAMMALS
DETECTION OF GASTROINTESTINAL DISORDERS AND THE SUBSEQUENT BREATH COLLECTION AND
MEASUREMENT OF 13CO2
DEVICE FOR COLLECTING A BREATH SAMPLE
METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN SUFFERING FROM OR SUSCEPTIBLE TO
PSYCHOSIS, ACUTE MANIA OR MILD ANXIETY STATES
METHOD OF USE FOR CONTROLLING HYPERGLYCEMIA BY ADMINISTRATION OF THIS SUSTAINED
RELEASE DOSAGE FORM OF GLIPIZIDE
RELIEF OF SYMPTOMS OF THE COMMON COLD
METHOD OF TREATING ANXIETY RELATED DISORDERS INCLUDING OBSESSIVE COMPULSIVE
DISORDER

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 32 of 73

PATENT USE
U-153
U-154
U-155
U-156
U-157
U-158
U-159
U-160
U-161
U-162
U-163
U-164
U-165
U-166
U-167
U-168
U-169
U-170
U-171
U-172
U-173
U-174
U-175
U-176
U-177
U-178
U-179
U-180
U-181
U-182
U-183
U-184
U-185
U-186

U-187
U-188
U-189
U-190
U-191
U-192
U-193
U-194
U-195
U-196
U-197
U-198

U-199

TREATMENT OF INITIAL EPISODE GENITAL HERPES

METHOD OF TREATING ANIMALS SUFFERING FROM AN APPETITE DISORDER
TREATMENT OF ERECTILE DYSFUNCTION
METHOD OF PROVIDING ANESTHESIA
TREATMENT OF A HUMAN SUFFERING FROM VITAMIN B12 DEFICIENCY
ANGINA
TREATMENT OF INTERSTITIAL CYSTITIS
TREATMENT OF BACTERIAL INFECTIOUS DISEASE
METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS IN A PATIENT
METHOD OF USE TO INHIBIT CHOLESTEROL SYNTHESIS IN A HUMAN SUFFERING FROM
HYPERCHOLESTEROLEMIA
METHOD OF USING TROGLITAZONE TO TREAT IMPAIRED GLUCOSE TOLERANCE TO PREVENT OR
DELAY THE ONSET OF NONINSULIN-DEPENDENT DIABETES MELLITUS
METHOD OF USING TROGLITAZONE TO PREVENT OR DELAY THE ONSET OF NONINSULIN-DEPENDENT
DIABETES MELLITUS IN A DEFINED POPULATION OF PATIENTS
TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
TREATMENT OF H.PYLORI-ASSOCIATED DUODENAL ULCER
METHOD FOR TREATING HIV-1 INFECTION
METHOD OF INHIBITING LIPOXYGENASE ACTIVITY IN A MAMMAL WHICH IS THE MODE OF ACTION
IN THE TREATMENT OF ASTHMA
METHODS OF USING THE COMPOUND/DRUG PRODUCT AS A CONTRAST AGENT IN MAGNETIC
RESONANCE IMAGING
METHOD OF OBTAINING AN MR IMAGE USING THE COMPOSITION/DRUG PRODUCT AS A CONTRAST
AGENT
METHODS OF USING THE COMPOUND/DRUG PRODUCT AS AN ORAL CONTRAST AGENT IN MAGNETIC
RESONANCE IMAGING OF THE GASTROINTESTINAL TRACT
TREATMENT OF GENITAL WARTS
ADMINISTRATION TO A HOST SUFFERING FROM GESTATIONAL DIABETES
USE AS AN ANTIHISTAMINE AGENT
METHOD OF TREATING MALIGNANT TUMORS
METHOD OF TREATING A PATIENT SUFFERING FROM LISTED CONDITIONS, INCLUDING SPECIFIC
PSYCHOSES
FUNGICIDE
FACILITATED ADHERENCE OF AGENTS TO SKIN
ENHANCED CUTANEOUS PENETRATION OF A DERMALLY-APPLIED PHARMACOLOGICALLY ACTIVE
AGENT
TREATMENT OF ADULT AND PEDIATRIC PATIENTS (OVER 6 MONTHS OF AGE) WITH ADVANCED HIV
INFECTION
PRODUCING ALPHA ADRENERGIC ANTAGONISTIC ACTION IN A HOST
USE OF SALMETEROL IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
TREATMENT OF CONDITIONS CAUSED BY DISTURBANCE OF NEURONAL 5HT FUNCTION
TREATING ALLERGIC EYE DISEASES IN HUMANS
METHOD OF TREATING HYPERTENSION
METHOD FOR TREATING GI DISORDERS CAUSED BY H.RYLORI WHICH COMPRISES ADMINISTRATION
OF RANITIDINE BISMUTH CITRATE AND CLARITHROMYCIN FOR A GREATER THAN ADDITIVE
EFFECT
THERAPEUTIC TREATMENT OF CALCIFIC TUMORS
TREATMENT OF H.PYLORI ASSOCIATED DUODENAL ULCER
ENHANCEMENT OF THE BIOAVAILABILITY OF THE DRUG SUBSTANCE
USE OF RITONAVIR IN COMBINATION WITH ANY REVERSE TRANSCRIPTASE INHIBITOR
METHOD OF TREATMENT FOR CONTROLLING AND LOWERING INTRAOCULAR PRESSURE IN A HUMAN
USE IN TREATING ALLERGIC REACTIONS
PSORIASIS
TREATING ANGINA PECTORIS AND HIGH BLOOD PRESSURE
METHOD FOR THE DIAGNOSIS OF GASTROINTESTINAL DISORDERS BY UREA ISOTOAC OR NITROGEN
LABELED CARBON
TREATMENT OF METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH ESTROGEN
RECEPTOR POSITIVE TUMORS
USE IN COMBINATION WITH CERTAIN LHRH ANALOGUES FOR THE TREATMENT OF ADVANCED
PROSTATE CANCER
TREATMENT METASTATIC CARCINOMA OF OVARY AFTER 1ST LINE FAILURE OR SUBSQUENT
CHEMOTHERAPY, TREATMENT OF BREAST CANCER AFTER FAILURE OF COMBINATION CHEMOTHERAPY
FOR METASTATIC DISEASE AND 2ND LINE TREATMENT OF AIDS RELATED KAPOSI'S SARCOMA
METHOD OF TREATING INFECTIOUS UPPER GI TRACT DISORDERS CAUSED BY CAMPYLOBACTER
PYLORIDIS INFECTION COMPRISING ADMINISTRATION OF A BISMUTH AGENT AND AN
ANTIMICROBIAL AGENT

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PATENT AND EXCLUSIVITY TERMS

ADB 33 of 73

PATENT USE
U-200
U-201
U-202
U-203
U-204
U-205
U-206
U-207
U-208
U-209
U-210
U-211
U-212
U-213
U-214
U-215

U-216
U-217
U-218
U-219
U-220
U-221
U-222
U-223
U-224
U-225
U-226
U-227
U-228
U-229
U-230
U-231
U-232
U-233
U-234
U-235

U-236
U-237
U-238

U-239

U-240
U-241

U-242
U-243

METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF A BISMUTH-CONTAINING

AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF CAMPYLOBACTERINHIBITING ANTIMICROBIAL AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
METHOD OF TREATING PEPTIC ULCER DISEASE CAUSED BY CAMPYLOBACTER PYLORIDIS
COMPRISING ORAL ADMINISTRATION OF 50 TO 5,000MG BISMUTH DAILY FOR 3-56 DAYS
TREATMENT OF ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE
PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
USE OF TAXOL IN COMBINATION WITH G-CSF FOR TREATMENT OF PATIENTS WITH AIDS-RELATED
KAPOSI'S SARCOMA
METHOD FOR TREATING HEARTBURN
METHOD OF USING FSH ALONE, WITHOUT THE PRESENCE OF EXOGENEOUS LH, IN IN VITRO
FERTILIZATION
USE AS NASAL SPRAY
VAGINAL ADMINISTRATION USING SPECIFIED FORMULATION
VAGINAL ADMINISTRATION OF PROGESTERONE USING SPECIFIED FORMULATION
METHOD OF TREATING CONGESTIVE HEART FAILURE
USE IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
METHOD OF TREATMENT OF PARKINSON'S DISEASE
METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS AND TREATING HYPERCHOLESTEROLEMIA
AND METHOD FOR TREATING HYPERLIPIDEMIA
USE AS A BLOOD GLUCOSE-LOWERING AGENT
TREATMENT OF EPILEPSY TWICE DAILY. TREATING A PATIENT BY ADMINISTERING
CARBAMAZEPINE IN A DOSAGE FORM CAPABLE OF MAINTAINING BLOOD CONCENTRATION FROM 412MCG/ML OVER 12 HOURS
TREATMENT OF ADENOCARCINOMA, INCLUDING STAGE B2-C BY ADMINISTERING AN AGONIST OF
LH-RH AND FLUTAMIDE
METHOD OF PRODUCING ANESTHESIA
METHOD FOR LIMITING THE POTENTIAL FOR MICROBIAL GROWTH IN THE DRUG PRODUCT
TREATMENT OF PARKINSON'S DISEASE
METHOD OF DIAGNOSIS
SELECTIVE VASODILATION BY CONTINUOUS ADENOSINE INFUSION
METHOD OF TREATING PAGET'S DISEASE USING ACTONEL
TREATMENT OF BACTERIAL CONJUNCTIVITIS CAUSED BY SUSCEPTIBLE STRAINS OF
MICROORGANISMS
CONTROLLING INTRAOCULAR PRESSURE
METHOD FOR DELIVERY
METHOD OF ENHANCING THE DISSOLUTION PROFILE OF A PHARMACEUTICAL FROM A SOLID
DOSAGE FORM CONTAINING THE PHARMACEUTICAL AND SIMETHICONE
NASAL ADMINISTRATION
ASTHMA
CARDIAC INSUFFICIENCY (CONGESTIVE HEART FAILURE)
PREVENTION OF ACUTE CARDIAC ISCHEMIC EVENTS
USE IN PARKINSON'S DISEASE
METHOD OF TREATING MIGRAINE
DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
METHOD OF USING RIBAVIRIN TO TREAT VIRAL INFECTIONS IN MAMMALS
METHOD OF MODULATING TH1 AND TH2 RESPONSE IN ACTIVATED T CELLS OF A HUMAN
COMPRISING ADMINISTERING RIBAVIRIN TO THE T CELLS IN A DOSAGE WHICH PROMOTES THE
TH1 RESPONSE AND SUPPRESSES THE TH2 RESPONSE
TREATING MALE PATTERN BALDNESS WITH 0.05 TO 3.0MG/DAY
METHOD OF PERFORMING NMR IMAGING WITH A PATIENT COMPRISING ADMINISTERING TO THE
PATIENT AN EFFECTIVE AMOUNT OF CONTRAST AGENT DISCLOSED IN THE CLAIMS
IMAGING A BODY TISSUE AND SUBJECTING TO NMR TOMOGRAPHY, ADMINISTERING AN AMOUNT OF
PHARMACEUTICAL AGENT FOR AFFECTING THE RELAXATION TIMES OF ATOMS IN BODY TISSUES
UNDERGOING NMR DIAGNOSIS, WHEREBY THE IMAGE CONTRAST IN ENHANCED....
TREATING OR CONTROLLING OCULAR INFLAMATION WHICH COMPRISES TOPICALLY ADMINISTERING
TO AFFECTED EYE A COMPOSITION COMPRISING AN NSAID, A POLYMERIC QUATERNARY AMMONIUM
COMPOUND AND BORIC ACID
TREATMENT OF ACUTE MIGRAINE ATTACKS
FOR SHORT-TERM TREATMENT ACTIVE DUODENAL ULCER, MAINTENANCE THERAPY FOR DUODENAL
ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING OF ACTIVE ULCER, SHORT-TERM
TREATMENT ACTIVE BENIGN GASTRIC ULCER & GERD, PATHOLOGICAL HYPERSECRETORY
CONDITIONS
USE OF FOLLITROPIN ALPHA ALONE IN IN-VITRO FERTILIZATION
TOPICAL ADMINISTRATION

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PATENT AND EXCLUSIVITY TERMS

ADB 34 of 73

PATENT USE
U-244
U-245
U-246
U-247
U-248
U-249
U-250
U-251
U-252
U-253
U-254
U-255
U-256
U-257
U-258
U-259
U-260

U-261
U-262
U-263

U-264

U-265
U-266

U-267

U-268
U-269
U-270
U-271
U-272
U-273
U-274
U-275
U-276
U-277
U-278
U-279
U-280
U-281
U-282
U-283
U-284
U-285
U-286
U-287
U-288
U-289
U-290
U-291

PLATELET AGGREGATION INHIBITORS

TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
PHOSPHATE BINDING
TREATMENT OF RHEUMATOID ARTHRITIS
TREATMENT OF HIV
METHOD OF TREATING ALLERGIC OR NON-ALLERGIC RHINITIS IN PATIENTS BY ADMINISTERING
AEROSOLIZED PARTICLES OF MOMETASONE FUROATE
TREATMENT OF HEPATITIS B INFECTION
USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS IN THE TREATMENT OF TYPE II
DIABETES
METHOD OF TREATING A HUMAN SUBJECT HAVING GAUCHER'S DISEASE
ORAL TRANSMUCOSAL USE
USE OF AGGRASTAT IN COMBINATION WITH HEPARIN
IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH
NARCOLEPSY
TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV
ANTIVIRAL AGENTS
TREATMENT OF HIV INFECTION
TREATMENT OF NEURODEGENERATIVE DISEASES
TREATMENT OF ANDROGENIC ALOPECIA BY ORAL ADMINISTRATION DRUG SUBSTANCE
REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA AND OCULAR
HYPERTENSION WHO ARE INTOLERANT OF OTHER IOP LOWERING MEDICATIONS OR
INSUFFICIENTLY RESPONSIVE TO ANOTHER IOP LOWERING MEDICATION
TREATING BENIGN PROSTATIC HYPERPLASIA WITH A GENUS OF COMPOUNDS, INCLUDING
FINASTERIDE
TREATING BENIGN PROSTATIC HYPERTROPHY WITH FINASTERIDE
METHOD OF TREATING A MALIGNANT CONDITION THROUGH INTRAVASCULAR ADMINISTRATION OF
BUSULFAN. METHOD FOR TREATING LEUKEMIA OR LYMPHOMA IN A PATIENT UNDERGOING A BONE
MARROW TRANSPLANT THROUGH INTRAVENOUS ADMINISTRATION OF BUSULFAN
METHOD OF TREATING A MALIGNANT DISEASE THROUGH PARENTERAL ADMINISTRATION OF
BUSULFAN. METHOD FOR TREATING A PATIENT UNDERGOING A BONE MARROW TRANSPLANT
THROUGH INTRAVASCULAR ADMINISTRATION OF BUSULFAN
USE AS LAXATIVE
RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS; RELIEF OF THE SIGNS AND
SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS; MANAGEMENT OF ACUTE PAIN IN ADULTS;
TREATMENT OF PRIMARY DYSMENNORRHEA; ACUTE TREATMENT OF MIGRAINE ATTACKS IN ADULTS
PREVENTING HEARTBURN EPISODES FOLLOWING INGESTION OF HEARTBURN-INDUCING
FOOD/BEVERAGE, COMPRISING ADMIN TO PT, 30 MIN PRIOR TO CONSUMPTION BY THE PT THE
FOOD/BEVERAGE, A COMPOSITION COMPRISING 10MG FAMOTIDINE
ACROMEGALY
EXCESS GH-SECRETION OR GASTRO-INTESTINAL DISORDERS
METHOD OF IMPROVING THE TIME FOR ADMINISTRATION OR THE TIME BETWEEN CHANGES OF
GIVING SETS FOR THE DRUG PRODUCT
METHOD OF TREATING TUMORS
METHOD OF TREATING CARCINOMA
CUTANEOUS T-CELL LYMPHOMA
ZANAMIVIR FOR INHALATION
METHOD OF USE OF THE DRUG SUBSTANCE
METHOD OF USE OF LEVOBUPIVACAINE
NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING)
METHOD OF USE OF THE INDICATION OF THE DRUG PRODUCT
METHOD OF USE OF THE APPROVED PRODUCT
TREATING PRECIPITATED ACUTE URINARY RETENTION WITH FINASTERIDE
ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS
METHOD OF TREATING BACTERIAL INFECTIONS
METHOD FOR TREATING MENOPAUSAL SYMPTOMS IN A POSTMENOPAUSAL FEMALE
MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCIATED
WITH MENOPAUSE, AND VULVAR AND VAGINAL ATROPHY) AND OSTEOPOROSIS
DEPRESSION AND SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA
DEPRESSION
TREATMENT OR PREVENTION OF OSTEOPOROSIS
THERAPY OF INFLUENZA
TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS)
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 35 of 73

PATENT USE

U-292
U-293
U-294
U-295
U-296

U-297
U-298
U-299
U-300
U-301
U-302
U-303
U-304
U-305
U-306
U-307

U-308

U-309
U-310
U-311
U-312
U-313
U-314
U-315
U-316
U-317
U-318
U-319
U-320
U-321
U-322
U-323
U-324
U-325
U-326
U-327
U-328
U-329

U-330
U-331
U-332

CYCLOSPORIN
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
AZATHIOPRINE
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH A
CORTICOSTEROID
TREATMENT OF HYPERPIGMENTARY DISORDERS
TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
TREATING MIGRAINE PAIN AND ONE OR MORE OF A CLUSTER OF SYMPTOMS CHARACTERISTIC OF
A MIGRAINE ATTACK SYMPTOMS BEING SELECTED FROM PHOTOPHOBIA, PHONOPHOBIA NAUSEA AND
FUNCTIONAL DISABILITY
PREVENTION OR TREATMENT OF REVERSIBLE VASOCONSTRICTION BY THE INHALATION OF NITRIC
OXIDE WITH AN OXYGEN CONTAINING GAS
METHOD OF COMBATING BACTERIA IN A PATIENT
TREATMENT OF ADENOMATOUS POLYPS
INDICATED FOR THE REDUCTION OF ELEVATED TOTAL AND LDL CHOLESTEROL LEVELS IN
PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS AND BIGUANIDES IN THE
TREATMENT OF TYPE II DIABETES
TO REDUCE THE RISK OF STROKE IN PATIENTS WHO HAVE HAD TRANSIENT ISCHEMIA OF THE
BRAIN OR COMPLETED ISCHEMIC STROKE DUE TO THROMBOSIS
METHOD OF USE PATENT-PRODUCT APPROVED FOR TREATMENT OF OSTEOPOROSIS, PAGET'S
DISEASE, PREVENTION AND TREATMENT OF GLUCOCORTICOID INDUCED OSTEOPOROSIS
A METHOD OF TREATMENT OF A CONDITION INVOLVING AN ANTIBODY ANTIGEN REACTION
METHODS FOR USING THE DRUG PRODUCT
TREATMENT OF POST-MENOPAUSAL UROGENITAL SYMPTOMS ASSOCIATED WITH ESTROGEN
DEFICIENCY
CLAIMS AN OLANZAPINE POLYMORPH USEFUL FOR TREATING ANY NUMBER OF LISTED
CONDITIONS, INCLUDING SPECIFIC PSYCHOSES,EMPLOYING OLANZAPINE AS PER THE
INDICATION OF THIS NDA
CLAIMS A SOLID ORAL FORMULATION INCLUDING TABLETS AND GRANULES OF OLANZAPINE
USEFUL FOR TREATING ANY NUMBER OF LISTED CONDITIONS, INCLUDING SPECIFIC PSYCHOLES,
EMPLOYING OLANZAPINE AS PER THE INDICATIONS OF THIS NDA
TREATING SJOEGREN SYNDROME
TREATMENT OF XEROSTOMIA
HORMONE REPLACEMENT
PANIC DISORDER, OBSESSIVE-COMPULSIVE DISORDER, POSTTRAUMATIC STRESS DISORDER
TREATMENT OF CONGESTIVE HEART FAILURE
METHOD FOR TREATING HYPERPARATHYROIDISM WHICH COMPRISES SUPPRESSING PARATHYROID
ACTIVITY
METHOD FOR ADMINISTERING DRUG TO GASTROINTESTINAL TRACT
METHOD OF TREATING A SUBJECT SUFFERING FROM PROSTATE CANCER
METHOD OF USING TROGLITAZONE TO TREAT PATIENTS HAVING INSULIN RESISTANCE
TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY
FREQUENCY, URGENCY, OR URGE INCONTINENCE
TREATMENT OF MICROBIAL INFECTIONS
INHIBITING OR ELIMINATING ACUTE MYELOID LEUKEMIA
REDUCTION OF ELEVATED IPTH LEVELS IN THE MGT OF SECONDARY HYPERPARATHYROIDISM IN
PATIENTS UNDERGONG CHRONIC RENAL DIALYSIS
TREATMENT OF ALZHEIMER'S DEMENTIA
USE AS A BILE ACID SEQUESTRANT
METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN, SUFFERING FROM OR SUSCEPTIBLE TO
PSYCHOSIS OR ACUTE MANIA EMPLOYING OLANZAPINE
METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS,
INCLUDING "BIPOLAR DISORDER NOS" EMPLOYING OLANZAPINE
METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER
METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED PSYCHOTIC
CONDITONS EMPLOYING OLANZAPINE
METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS
INCLUDING "A PSYCHOTIC CONDITION" EMPLOYING AN OLANZAPINE POLYMORPH
USE OF AVANDIA AS MONOTHERAPY, IN COMBINATION WITH METFORMIN, AND IN COMBINATION
WITH SULFONYLUREAS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES
MELLITUS
TREATMENT OF NAUSEA AND VOMITING
METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN
THE EVENING OR AT NIGHT
TREATMENT OR PREVENTION OF BRONCHOSPASM

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PATENT AND EXCLUSIVITY TERMS

ADB 36 of 73

PATENT USE
U-333
U-334
U-335
U-336
U-337
U-338
U-339
U-340
U-341
U-342
U-343
U-344
U-345
U-346

U-347
U-348
U-349
U-350
U-351
U-352
U-353
U-354

U-355
U-356
U-357

U-358
U-359
U-360

U-361
U-362
U-363

U-364

U-365
U-366
U-367
U-368
U-369
U-370
U-371
U-372

METHOD OF TREATING OCULAR HYPERTENSION

TREATMENT OF EXCESSIVE FEMALE FACIAL HAIR
USE OF PRAVASTATIN SODIUM FOR SECONDARY PREVENTION OF CORONARY EVENTS IN MEN AND
WOMEN WHO HAVE HAD A MYOCARDIAL INFARCTION AND HAVE NORMAL CHOLESTEROL LEVELS
DIAGNOSTIC RADIOIMAGING
USE OF CARDIOLITE/MIRALUMA KIT FOR THE PREPARATION OF TC99M SESTAMIBI
METHODS FOR TREATING DISTURBANCES OF MOOD, DISTURBANCES OF APPETITE, DEPRESSED
MOOD, OR CARBOHYDRATE CRAVING ALL ASSOCIATED WITH PREMENSTRUAL SYNDROME
PREVENTION OF CARDIO-TOXICITY CAUSED BY THE ADMINISTRATION OF DOXORUBICIN
THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS
GROWTH HORMONE SECRETION IN CHILDREN
METHOD FOR ENHANCING THE TREATMENT OF ... LATE LUTEAL PHASE DYSPHORIC DISORDER
METHOD FOR TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER
REDUCTION OF INTESTINAL GAS, CRAMPING AND ANORECTAL IRRITATION
METHOD FOR INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH
ANOTHER HIV PROTEASE INHIBITOR
RITONAVIR AND ANOTHER HIV PROTEASE INHIBITOR FOR CONCOMITANT ADMINISTRATION FOR
THE TREATMENT OF AN HIV INFECTION
METHOD FOR INHIBITING CYTOCHROME P450 MONOOXYGENASE WITH RITONAVIR AND A METHOD
FOR IMPROVING THE PHARMCOKINETICS OF A DRUG THAT IS MTABOLIZED BY CYTOCHROME P450
MONOOXYGENASE BY ADMIN THE DRUG AND RITONAVIR
METHOD OF USE IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS
METHOD OF USE FOR INHIBITING HIV INFECTION
METHOD OF USE WHICH IS SUBJECT OF THE APPLICATION
PREPARATION OF A PHARMACEUTICAL COMPOSITION FOR CONCOMITANT ADMIN WITH A REVERSE
TRANSCRIPTASE INHIBITOR
INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR
INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH A REVERSE
TRANSCRIPTASE INHIBITOR
PREVENTION AND TREATMENT OF OSTEOPOROSIS
METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENTLIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY
DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
METHOD OF ASSISTING PERSON TO QUIT SMOKING...TRANSDERMALLY ADMIN NICOTINE
VIA..PATCH ADHERED TO SKIN AT DOSING RATE APPROX SAME AS ABSORBED FROM SMOKING
DELIVERING A MEDICINAL AEROSOL FORMULATION USING CFC-FREE PROPELLANT 134A.
USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF
AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED
NEOVASCULATURE IN THE EYE
DEPRESSION, OBSESSIVE COMPULSIVE DISORDER, PANIC DISORDER AND SOCIAL ANXIETY
DISORDER
METHOD OF USE OF VISICOL
METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL
PSYCHOLOGICAL CONDITIONS INCLUDING MENTAL DISORDERS EMPLOYING OLANZAPINE AS PER
THE INDICATION WHICH IS THE SUBJECT MATTER OF THIS SNDA-011
MANAGEMENT OF ANXIETY DISORDERS AND THE SHORT-TERM RELIEF OF THE SYMPTOMS OF
ANXIETY
USE OF APPROVED FORMULATIONS TO TREAT ALL APPROVED DISEASE INDICATIONS
METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL
PSYCHOLOGICAL CONDITIONS THAT RELATE TO THE USE OF A PSYCHOACTIVE SUBSTANCE
EMPLOYING OLANZAPINE AS PER THE INDICATION THE SUBJECT MATTER OF SUPPLEMENT 011
TREATING A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ANY NUMBER OF LISTED
CONDITIONS INCLUDING PSYCHOSIS, EMPLOYING OLANZAPINE AS PER THE INDICATION WHICH
IS THE SUBJECT MATTER OF THIS SNDA-011
METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
CALCIUM BLOCKING VASODILATOR IN OUR EXTENDED, CONTROLLED RELEASE FORMULATION
METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
CALCIUM BLOCKING VASODILATOR IN A DELAYED RELEASE FORMULATION
TREATMENT OF CARDIOVASCULAR DISORDERS
HEARTBURN
METHOD OF CONTROLLING AND LOWERING INTRAOCULAR PRESSURE
INTRAVAGINAL TREATMENT OF VAGINAL INFECTIONS WITH BUFFERED METRONIDAZOLE
COMPOSITIONS
APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA
CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)
METHOD FOR ADMINISTERING A BENEFICIAL DRUG TO THE GI TRACT OF AN ANIMAL, WHICH
METHOD COMPRISES ADMITTING AN OSMOTIC DEVICE ORALLY INTO THE ANIMAL...

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 37 of 73

PATENT USE
U-373

U-374

U-375
U-376
U-377

U-378
U-379
U-380
U-381
U-382
U-383
U-384
U-385
U-386
U-387
U-388
U-389
U-390
U-391
U-392
U-393

U-394
U-395
U-396
U-397
U-398
U-399
U-400

U-401
U-402
U-403
U-404
U-405
U-406
U-407
U-408
U-409
U-410

U-411

U-412
U-413
U-414

GENERAL USE CLAIM SUBMITTED FOR 12 NEXIUM PATIENTS STATING "PERTINENT TO THE
CAPSULE FORMULATION FOR NEXIUM AND ITS INDICATIONS FOR THE TREATMENT OF GERD AND
ERADICATION OF H.PYLORI TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
KIT ADAPTED AND DESIGNED TO PROVIDE BOTH DATA ON THE CURRENT REPRODUCTIVE STATUS
OF A PATIENT AND CONTRACEPTION FOR THOSE WHO ARE NOT PREGNANT, BUT RECENTLY
ENGAGED IN UNPROTECTED SEX
METHOD OF USING RIBAVIRIN FOR TREATING A DISEASE RESPONSIVE TO RIBAVIRIN, E.G.
HEPATITIS C
TREATMENT OF INFLUENZA
METHOD OF TREATING PT WITH CHRONIC HEPATITIS C HAVING HCV GENOTYPE 1 AND VIRAL
LOAD GREATER THAN 2 MILLION COPIES/ML TO ERADICATE DETECTABLE HCV-RNA BY ADMIN
COMBINATION OF RIBAVIRIN AND INTERFERON ALFA-2B FOR A LEAST 24 WEEKS
METHOD FOR TREATING INCONTINENCE
METHOD OF TREATING ONYCHROMYCOSIS
COMBINATIONS OF TAXOL (PACLITAXEL) AND CISPLATIN WHICH ARE SUITABLE FOR THE
TREATMENT OF OVARIAN AND NON-SMALL CELL LUNG CARCINOMAS
TREATMENT OF HYPERPHOSPHATEMIA
METHOD OF STABLIZING PROSTAGLANDIN
METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION
TREATMENT OF CMV RETINITIS
TREATMENT OF PEPTIC ULCERS
TREATMENT OF PATIENTS SUFFERING FROM A LATE ASTHMATIC REACTION OR LATE PHASE
ASTHMA
TREATMENT OF PATIENTS WITH RESPIRATORY DISORDERS
SMOKING CESSATION AID APPLIED TO THE SKIN
SMOKING CESSATION AID APPLIED TO THE SKIN ON WAKING AND REMOVED PRIOR TO SLEEP
AFTER ABOUT 16 HOURS
METHOD OF USING THE DRUG TO TREAT NEUROIMMUNOLOGIC DISEASES (INCLUDING MULTIPLE
SCLEROSIS)
USE OF CASODEX IN COMBINATION WITH LHRH AGONISTS FOR THE TREATMENT OF PROSTATE
CANCER
TREATMENT OF PATIENTS FOR INFLAMMATION
MANAGEMENT OF INCONTINENCE, MGT OF HORMONE REPLACEMENT THERAPY, TREATMENT OF
INVOLUNTARY INCONTINENCE, MGT OVERACTIVE BLADDER AND INCREASING COMPLIANCE IN SUCH
PT
METHOD OF USE OF ALPHAGAN
METHOD OF USE OF ALPHAGAN P
METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION
METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION WITHOUT AN INCREASE IN NAUSEA
TREATMENT OF GENERALIZED ANXIETY DISORDER
IN-THE-EYE USE OF CHLORINE DIOXIDE CONTAINING COMPOSITIONS
USE OF RIBAVIRIN TO INCREASE TYPE 1 CYTOKINE RESPONSE AND SUPPRESS TYPE 2 CYTOKINE
RESP0NSE TO LYMPHOCYTES, INCLUDING METHODS THAT TAKE ADVANTAGE OF SUCH MODULATION
TO TREAT INFECTIONS AND INFESTATIONS
USE OF LOPINAVIR IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS FOR TREATING
HIV INFECTION AND IN COMBO WITH OTHER HIV PROTEASE INHIBITORS
TREATMENT OF ACTINIC KERATOSES
ANTI-ALLERGIC FOR VARIOUS ALLERGIC DISEASES
TREATMENT OF ALLERGIC CONJUNCTIVITIS
FOR WOMEN WITH SEVERE DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS)
METHOD OF USE OF ATOVAQUONE AND PROGUANIL
METHOD OF TREATING OTOPATHY
FOR INDUCING OVULATION IN CONJUNCTION WITH A GONADOTROPIN RELEASING FACTOR
ANTAGONIST AND RECRUITING OOCYTES FOR IN-VITRO FERTILIZATION
METHOD OF TREATING INFLAMMATION USING DRUG SUBSTANCE
METHOD OF REDUCING AMOUNT OF RESPECTIVE ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA
(INCLUDING PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
METHOD OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA
(WHICH INCLUDES PIOGLITAZONE) IN COMBINATION WITH AN INSULIN PREPARATION
TREATMENT OF TYPE 2 DIABETES
USE OF THE ACTIVE INGREDIENT FOR INHIBITING THE BIOSYNTHESIS OF CHOLESTEROL AND
TREATMENT OF ATHEROSCLEROSIS
A METHOD OF TREATING GLYCOMETABOLISM DISORDERS BY ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 38 of 73

PATENT USE
U-415

U-416

U-417
U-418

U-419
U-420
U-421
U-422
U-423
U-424
U-425

U-426
U-427
U-428
U-429
U-430

U-431
U-432

U-433
U-434
U-435
U-436
U-437
U-438
U-439
U-440

U-441
U-442

U-443
U-444
U-445
U-446
U-447
U-448

U-449

U-450

A METHOD FOR REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC

PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE)
IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
A METHOD FOR REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE)
IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
COMBINATION USE OF AD-4833 WITH A BIGUANIDE
A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING A CHEMICAL
COMPOUND HAVING A PARTICULAR FORMULA (WHICH INCLUDES PIOGLITAZONE) IN COMBINATION
WITH AN INSULIN SECRETION ENHANCER
A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
METHOD OF TREATMENT OF TYPE II DIABETES
USE FOR SEDATION
METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER AND ATTENTION
DEFICIT HYPERACTIVITY DISORDER
METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER, ATTENTION DEFICIT
HYPERACTIVITY DISORDER, OR AIDS RELATED DEMENTIA
FOR ONCE DAILY, BOLUS ADMINISTRATION TO A PATIENT IN ORDER TO ENGENDER TREATMENT
FOR A NERVOUS DISORDER FOR SUBSTANTIALLY AN ENTIRE DAY ON A CHRONIC BASIS
METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN
A CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN
INSULIN SECRETION ENHANCER
PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN
STIMULATION
METHOD OF TREATING ALLERGIC REACTIONS IN MAMMALS
METHOD OF TREATING ALLERGY IN A MAMMAL USING THIS ACTIVE METABOLITE
METHOD OF USING DESLORATADINE TO TREAT ALLERGIC RHINITIS
METHOD OF TREATING A DIABETIC BY ADMINISTERING AN INSULIN SENSITIZER IN
COMBINATION WITH AN INSULIN SECRETION ENHANCER, AND A DRUG PRODUCT C0MPRISING AN
INSULIN SENSITIZER AND AN INSULIN SECRETION ENHANCER
POSTTRAUMATIC STRESS DISORDER
REDUCTION OF ATHEROSCLEROTIC EVENTS (MYOCARDIAL INFARCTION, STROKE, AND VASCULAR
DEATH) IN PATIENTS WITH ATHEROSCLEROSIS DOCUMENTED BY RECENT STROKE, RECENT
MYOCARDIAL INFARCTION OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE
USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN
PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
CONTROLLED SYMPTOMS OF DIARRHEA, BLOATING PRESSURE AND CRAMPS, COMMONLY REFERRED
TO AS GAS
A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF
ABOUT 25MG
ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
METHOD OF USE EQUAL TO PROCESS OF PREPARATION
TREATMENT/PREVENTION OF NEURODEGENERATIVE DISEASE
TREATMENT OF OBESITY
METHOD FOR TRANSDERMAL ADMINISTRATION OF A DRUG THROUGH NON-SCROTAL SKIN USING A
TRANSDERMAL DRUG DELIVERY DEVICE CONTAINING THE DRUG AND HAVING AN ADHESIVE
SURFACE
METHOD OF TREATING MS BY ADMINISTERING COPAXONE
METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE
OCCURENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID
DRUG
MANAGEMENT OF MODERATE TO SEVERE PAIN WHEN A CONTINUOUS, AROUND-THE-CLOCK
ANALGESIC IS NEEDED FOR AN EXTENDED PERIOD OF TIME
TREATMENT OF MIGRAINE
USE AS AN ANTIMYCOTIC AGENT
TOPICAL TREATMENT OF OCULAR HYPERTENSION AND GLAUCOMA
METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN
THE EVENING OR AT NIGHT
METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENTLIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY
DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF
METASTATIC COLORECTAL CANCER WHERE THE DOSE OF LEUCOVORIN IS AT LEAST 200MG PER
SQUARE METER
INTERMEDIATE REL NICOTINIC ACID FORMULATIONS HAVING UNIQUE URINARY METAB PROFILES
RESULTING FROM ABSORPTION PROFILES OF NICOTINIC ACID FROM THE INTERMEDIATE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 39 of 73

PATENT USE

U-451
U-452
U-453
U-454

U-455
U-456

U-457
U-458
U-459
U-460
U-461
U-462
U-463
U-464
U-465
U-466
U-467
U-468
U-469
U-470
U-471
U-472
U-473
U-474

U-475
U-476

U-477

U-478

U-479
U-480
U-481
U-482
U-483
U-484
U-485
U-486

U-487
U-488

NICOTINIC ACID FORMULATIONS,SUITABLE FOR TX HYPERLIPIDEMIA FOLLOWING QD DOSING

TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
USE OF LANSOPRAZOLE FOR COMBATTING DISEASES CAUSED BY THE GENUS CAMPYLOBACTER
(C.PYLORI=H.PYLORI)
TREATMENT OF PLATELET ASSOCIATED ISCHEMIC DISORDERS
METHOD OF TX A PT SUSPECTED OF HAVING HEPATITIS C BY ADMIN, IN COMBINATION, A
CONJUGATE COMPRISING PEG 12000 & INTERFERON ALFA-2B IN AN AMT OF FROM 0.5MCG/KG TO
2MCG/KG, ONCE WEEKLY, AND RIBAVIRIN
TREATMENT OF PULMONARY HYPERTENSION WITH UT-15
METHOD OF DECREASING THE PRODUCTION OF A-BETA USING A COMPOSITION WHICH DECREASES
BLOOD CHOLESTEROL IN PATIENTS AT RISK OF OR EXHIBITING SYMPTOMS OF ALZHEIMER'S
DISEASE
METHOD OF TREATING A VAGINAL FUNGAL INFECTION IN A FEMALE HUMAN
METHOD OF USE OF IMAGENT
TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS
USING SERTRALINE
METHOD OF TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER (PMDD) USING
SERTRALINE
SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND ADULT RHEUMATOID ARTHRITIS AND TREATMENT
OF PRIMARY DYSMENORRHEA
VENOGRAPHY
PERIPHERAL ARTERIOGRAPHY
CT IMAGING OF THE HEAD
TREATMENT OF IRRITABLE BOWEL SYNDROME
USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE)
INHIBITOR FOR TREATING HYPERTENSION
METHOD OF USING FEXOFENADINE HCL IN TREATING ALLERGIC RHINITIS
TREATMENT OF GASTROESOPHAGEAL REFLEX DISEASE (GERD) AND ERADICATION OF H.PYLORI TO
REDUCE RISK OF DUODENAL ULCER RECURRENCE
THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION
METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BIMODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES
TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
TO REDUCE PLASMA CHOLESTEROL LEVELS BY ADMIN EZETIMIBE IN COMBO WITH CHOLESTEROL
BIOSYNTHESIS INHIB SELECTED FROM GROUP CONSISTING OF HMG COA REDUCTASE INHIBITORS
INCL SIMVASTATIN
TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO
ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
METHOD OF TREATING ANDROGEN RESPONSIVE/MEDIATED CONDITION IN MAMMAL BY ADMIN A
SAFE, EFFECTIVE AMOUNT OF DUTASTERIDE OR PHARMACEUTICALLY ACCEPTABLE DERIVATIVE
THEREOF..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY
METHOD OF INHIBITING 5 ALPHA TESTOSTERONE REDUCTASE ENZYME WITH DUTASTERIDE OR ITS
DERIVATIVE AND TREATING ANDROGEN RESPONSIVE/MEDIATED DISEASE INCLUDING BENIGN
PROSTATIC HYPERPLASIA
METHOD OF TREATING HEPATITIS C VIRAL INFECTION BY CONTINUOUS PARENTERAL ADMIN
INTERFERON ALPHA 2-10 MILLION IU WEEKLY, SUBCUTANEOUSLY, INJECTION OF POLYMERINTERFERON ALPHA CONJUGATE-POLYMER IS PEG-INTERFERON IS ALPHA 2B
METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL
COMBINATION THERAPY
CONTRAST AGENT FOR MRI
DISUBSTITUTED ACETYLENES BEARING HETEROAROMATIC AND HETEROBICYCLIC GROUPS HAVING
RETINOID-LIKE ACTIVITY
METHOD OF IN VITRO FERTILIZATION THERAPY INCLUDING MEANS FOR INDUCING
OVULATION....
METHOD FOR THE ADMINISTRATION OF DRUGS USING THAT COMPOUND
METHOD OF TREATING A SKIN DISEASE WITH A CORTICOSTEROID-CONTAINING PHARMACEUTICAL
COMPOSITION
METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES
(HERPES ZOSTER AND POST-HERPETIC NEURALGIA)
EXTERNAL PREPARATION FOR APPLICATION TO THE SKIN CONTAINING LIDOCAINE-DRUG
RETAINING LAYER PLACED ON SUPPORT AND COMPRISES ADHESIVE GEL BASE 1-10% BY WEIGHT
OF LIDOCAINE
METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES
(HERPES ZOSTER AND POST-HERPETIC NEURALGIA)
METHOD FOR REDUCING THE PAIN ASSOCIATED WITH HERPES-ZOSTER AND POST-HERPETIC

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 40 of 73

PATENT USE

U-489
U-490
U-491
U-492

U-493
U-494
U-495
U-496
U-497
U-498
U-499

U-500
U-501
U-502
U-503
U-504
U-505
U-506

U-507
U-508
U-509
U-510

U-511
U-512
U-513
U-514
U-515
U-516
U-517
U-518
U-519
U-520
U-521
U-522
U-523
U-524
U-525
U-526
U-527
U-528
U-529
U-530

U-531

NEURALGIA
EXPECTORANT
TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A
DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
METHOD OF DELIVERING A DRUG TO THE LUNG
METHOD FOR THE TREATMENT OF SKIN, SUFFERING FROM A CONDITION SELECTED FROM A GROUP
CONSISTING OF NONACNE INFLAMMATORY DERMATOSES... COMPRISING APPLYING TO AFFECTED
AREA. A THERAPEUTICALLY EFFECTIVE AMT AZELAIC ACID
TREATMENT OF TYPE 2 DIABETES MELLITUS
TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER
PERITONEAL DIALYSIS SOLUTION
METHOD FOR TREATING CHRONIC RENAL FAILURE
RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS
INTRA-ARTERIAL AND INTRAVENOUS USES OF ULTRAVIST
METHOD OF USING REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING
POLYETHYLENE GLYCOL(PEG) AND AN ALPHA INTERFERON, INCLUDING, FOR EXAMPLE, PEGINTRON POWDER FOR INJECTION
USE AS AN ANTIHYPERTENSIVE AGENT
TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
PITYRIASIS VERSICOLOR
GENERATOR MUST BE USED WITH INFUSION SYSTEM SPECIFICALLY LABELED FOR USE WITH
GENERATOR
TINEA PEDIS, TINEA CRURIS, TINEA CORPORIS
ULTRASOUND CONTRAST AGENT
PHARM PRODUCT CONTAINER 1ST CHAMBER IS DISPOSED AQUEOUS DILUENT SOL 2ND CHAMBER
PHARM ACTIVE AGENT COMPRISING ACETYLCHOLINE,BUFFER IN 1ST CHAM IS SUFFICIENT TO
BUFFER PH OF MIXED SOL RESULTING MIXTURE OF AQUEOUS DILUENT SOL & PHARM ACTIVE..
ACROMEGALY IN PATIENTS W/INADEQUATE RESPONSE TO SURGERY AND/OR RADIATION THERAPY
AND/OR MEDICAL THERAPIES, OR FOR WHOM THESE THERAPIES ARE NOT APPROPRIATE
METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER
PATTERN FOR AT LEAST THREE WEEKS
TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO
ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA
(STAGE IA AND IB) WHO HAVE REFRACTORY OR PERSISTENT DISEASE AFTER OTHER THERAPIES
OR WHO HAVE NOT TOLERATED OTHER THERAPIES
USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA
USE OF QUINOLONE COMPOUNDS AGAINST ATYPICAL UPPER RESPIRATORY PATHOGENIC BACTERIA
METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA
PREVENTION OF OVULATION IN A WOMAN
TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR
THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON THE LAST THERAPY
METHOD OF TREATING A PSYCHOTIC DISEASE
STABLE GEL FORMULATION FOR TOPICAL TREATMENT OF SKIN CONDITIONS
OBSESSIVE COMPULSIVE DISORDER
POST OPERATIVE NAUSEA AND VOMITING
PREMENOPAUSAL OSTEOPOROSIS
METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B
RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
TREATMENT OF CMV RETINITIS BY INTRAVITREAL ADMIN OF A PHOSPHOROTHIOATE
OLIGONUCLEOTIDE CAPABLE OF HYBRIDIZING WITH CMV MRNA
METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED
MAMMAL
METHOD OF TREATING DIARRHEA
METHOD OF TREATING PARASITIC INFECTIONS
METHOD OF PROVIDING CONTROLLED RELEASE OF A TREATING AGENT USING A CONTROLLED
RELEASE COMPOSITION
METHOD OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION
BIOADHESIVE
PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES,
SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS,
REDUCTION OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES
TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION. MAY BE USED ALONE OR GIVEN
WITH OTHER CLASSES OF ANTIHYPERTENSIVES, ESPECIALLY THIAZIDE DERIVATIVES

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 41 of 73

PATENT USE
U-532
U-533
U-534
U-535
U-536
U-537
U-538

U-539
U-540
U-541
U-542
U-543
U-544
U-545

U-546
U-547
U-548
U-549
U-550
U-551
U-552
U-553

U-554
U-555
U-556
U-557
U-558
U-559

U-560
U-561

U-562
U-563
U-564
U-565
U-566

U-567
U-568
U-569
U-570
U-571
U-572

TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE
BRONCHO DILATOR
ERECTILE DYSFUNCTION
HUMALOG IS AN INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH
DIABETES MELLITUS FOR THE CONTROL OF HYPERGLYCEMIA
TREATMENT OF SOCIAL ANXIETY DISORDER
CONTRAST AGENT FOR MAGNETIC RESONACE IMAGING
TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND
CARDIAC INSUFFICIENCY, WITH EPLERENONE
FIRST LINE TREATMENT OF SEVERE HYPERTENSION, IN PATIENTS WITH HYPERTENSION SEVERE
ENOUGH THAT THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS THE RISK
OF INITIATING COMBINATION THERAPY IN THESE PATIENTS
TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
TREATMENT OF FUNGAL INFECTIONS
METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION
TREATMENT OF SCHIZOPHRENIA
TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE.
METHOD FOR THE PREVENTION AND/OR TREATMENT OF THROMBOTIC EPISODES, SUCH AS
MYOCARDIAL INFARCTION, IN A HUMAN PATIENT AND METHOD FOR THE PREVENTION OF VENOUS
THROMBOSIS IN A POSTOPERATIVE HUMAN PATIENT
USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE
MAINTENANCE MONOTHERAPY FOR BIPOLAR DISORDER
A METHOD OF REDUCING FLUSH IN AN INDIVIDUAL BEING TREATED FOR A LIPIDEMIC DISORDER
AND EFFECTIVELY TREATING THE LIPIDEMIC DISORDER
USE IN THE TREATMENT OF MEN WITH ADVANCED SYMPTOMATIC PROSTATE CANCER
TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
METHOD FOR REDUCING TOXICITY OF ALIMTA TREATED PATIENTS BY ADMINISTERING FOLIC
ACID
TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION
MANAGEMENT OF PAIN AND DISCOMFORT ASSOCIATED WITH PERIDONTAL SCALING AND ROOT
PLANNING PROCEDURES BY APPLICATION OF AN EUTECTIC MIXTURE OF LOCAL ANESTHETICS TO
PERIDONTAL POCKETS
TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL
AGENTS
TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED
PYELONEPHRITIS
USE AS ADJUNCT DIAGNOSTIC FOR SERUM THYROGLOBULIN (TG) TESTING
NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
INDICATED FOR THE RELIEF OF BRONCHOSPASM IN PATIENTS 2-12 YEARS OF AGE WITH ASTHMA
(REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE)
METHOD OF DECREASING OR REDUCING PARATHYROID HORMONE LEVEL; METHOD OF MODULATING
PARATHYROID HORMONE SECRETION;METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF
REDUCING SERUM IONIZED CALCIUM LEVEL
METHOD OF DECREASING PARATHYROID HORMONE LEVEL;METHOD OF TREATING
HYPERPARATHYROIDISM
COSOPT IS INDICATED FOR THE REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS
WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION WHO ARE INSUFFICIENTLY RESPONSIVE
TO BETA BLOCKERS
TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH AIDS-RELATED KAPOSI'S
SARCOMA
MARINOL IS INDICATED FOR, INTER ALIA, ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN
PATIENTS WITH AIDS
TREATMENT OF HIV IN CONCOMITANT THERAPY
TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS, AND CHRONIC
URTICARIA
FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED
WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS
AND EMPHYSEMA
METHOD OF TREATING INFERTILITY
METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION
METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND
WHEREIN THEREAFTER AN OVULATORY INDUCING AMOUNT OF HCG IS ADMINISTERED
METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND
WHEREIN THE DAILY AMOUNT OF FSH IS ABOUT 5-10 IU/KG
TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA
INTENSIVE CARE UNIT SEDATION

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 42 of 73

PATENT USE
U-573
U-574

U-575

U-576
U-577
U-578

U-579
U-580
U-581
U-582

U-583

U-584
U-585
U-586

U-587

U-588

U-589

U-590

U-591
U-592
U-593
U-594
U-595
U-596
U-597
U-598
U-599
U-600
U-601
U-602

U-603
U-604
U-605

TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)

PROPHYLAXIS AND TREATMENT OF THE NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS AND
TREATMENT OF THE NASAL SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS IN ADULTS AND
PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
LOTEMAX OPTHALMIC SUSPENSION IS INDICATED FOR THE TREATMENT OF STEROID RESPONSIVE
CONDITIONS OF THE PALPEBRAL BULBAR CONJUNCTIVA, CORNEA AND ANTERIOR SEGMENT OF THE
GLOBE.
ALREX OPTHALMIC SUSPENSION IS INDICATED FOR THE TEMPORARY RELIEF OF THE SIGNS AND
SYMPTOMS OF SEASONAL ALLERGIC CONJUNCTIVITIS.
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH FINASTERIDE IN COMBINATION WITH
DOXAZOSIN
TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA, ACUTE EXACERBATION OF CHRONIC
BRONCHITIS, AND ACUTE BACTERIAL SINUSITIS CAUSED BY SUSCEPTIBLE STRAINS OF
DESIGNATED MICROORGANISMS IN PATIENTS 18 YEARS AND OLDER.
TREATMENT OF EPILEPSY AND/OR MIGRAINE.
TREATMENT OF DISORDERS OF THE SEROTONERGIC SYSTEM SUCH AS DEPRESSION AND ANXIETYRELATED DISORDERS
METHOD OF TREATING A CONDITION CAPABLE OF TREATMENT BY INHALATION, E.G. ASTHMA,
COMPRISING ADMINISTRATION OF A FORMULATION CLAIMED IN US PATENT NO. 6743413
METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING
ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A
METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO. 6253762
METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING
ADMINISTERING TO A PATIENT BY INHALATION, A METERED AEROSOL DOSE OF A DRUG
FORMULATION FROM THE METERED DOSE INHALER SYSTEM CLAIMED IN US 6546928
SINGLE-DOSE ADMINISTRATION BY THE EPIDURAL ROUTE, AT THE LUMBAR LEVEL, FOR THE
TREATMENT OF PAIN FOLLOWING MAJOR SURGERY
TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
AN INTERMEDIATE RELEASE NICOTINIC ACID FORMULATION SUITABLE FOR ORAL
ADMINISTRATION ONCE-A-DAY AS A SINGLE DOSE FOR TREATING HYPERLIPIDEMIA WITHOUT
CAUSING DRUG-INDUCED HEPATOTOXICITY OR ELEVATIONS IN URIC ACID OR GLUCOSE OR BOTH
USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE)
INHIBITOR (AND OPTIONALLY A DIURETIC) FOR TREATING CONGESTIVE HEART FAILURE AND
HYPERTENSION
SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER
SYMPTOMS ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS;
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
METHOD FOR TREATMENT OF A RESPIRATORY DISORDER, E.G., BRONCHOSPASM, COMPRISING
ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A
METERED DOSE INHALER SYSTEM AS CLAIMED IN U.S. PATENT NO. 6131966
METHOD FOR TREATMENT OF A RESPIRATORY DISORDER,E.G.,BRONCHOSPASM,COMPRISING
ADMINISTERING TO A PATIENT BY ORAL OR NASAL INHALATION A DRUG FORMULATION BY USING
THE METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO.6532955
TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING A DOSAGE FORM WHICH
PROVIDES ONCE-DAILY ORAL ADMINISTRATION OF A PHENIDATE DRUG
TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
35 MG ORALLY ONCE A WEEK FOR PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN;
35 MG ORALLY ONCE A WEEK FOR TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL
WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS
WHO ARE AT HIGH RISK FOR FRACTURE
PROPHYLACTIC TREATMENT OF MIGRAINE
METHOD FOR TREATING ALLERGIC CONJUNCTIVITIS
A METHOD OF TREATING A PATIENT IN NEED OF OPHTHALMIC ANTIMICROBIAL THERAPY WITH
LEVOFLOXACIN
TREATMENT OF BIPOLAR DISORDER
SIGNS AND SYMPTOMS OF OSTEOARTHRITIS, RHEUMATOID ARTHRITIS IN ADULTS, AND/OR
PAUCIARTICULAR OR POLYARTICULAR COURSE JUVENILE RHEUMATOID ARTHRITIS, ACUTE PAIN
IN ADULTS; PRIMARY DYSMENORRHEA; AND/OR ACUTE MIGRAINE ATTACKS IN ADULTS
METHOD OF TREATING INFECTIONS COMPRISING ORALLY ADMINISTERING AN EFFECTIVE AMOUNT
OF THE FDA APPROVED ORAL SUSPENSION
METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
TREATMENT OF MAJOR DEPRESSIVE DISORDER(MDD);ALTHOUGH THE MEHCHANISM OF THE

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PATENT AND EXCLUSIVITY TERMS

ADB 43 of 73

PATENT USE

U-606
U-607
U-608
U-609
U-610

U-611
U-612
U-613
U-614
U-615

U-616

U-617
U-618

U-619
U-620
U-621
U-622
U-623
U-624
U-625
U-626

U-627
U-628

U-629
U-630
U-631
U-632
U-633

U-634

U-635
U-636
U-637
U-638
U-639
U-640
U-641

ANTIDEPRESSANT ACTION OF DULOXETINE IN HUMANS IS UNKNOWN, IT IS BELIEVED TO BE

RELATED TO ITS POTENTIATION OF SERATONERGIC AND NORADRENERGIC ACTIVITY IN THE CNS
USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE
TREATMENT OF METASTATIC COLRECTAL CANCER
CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN
FEBRILE, NEUTROPENIC PATIENTS.
USE OF QUINOLONE COMPOUNDS AGAINST PNEUMOCOCCAL PATHOGENIC BACTERIA
USE OF QUINOLONE COMPOUNDS AGAINST QUINOLONE-RESISTANT PNEUMOCOCCAL PATHOGENIC
BACTERIA
ATROVENT HFA (IPRATROPIUM BROMIDE HFA) INHALATION AEROSOL IS INDICATED AS A
BRONCHODILATOR FOR MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC
OBSTRUCTIVE PULMONARY DISEASE, INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA.
METHOD OF USING DESLORATADINE TO TREAT SEASONAL AND PERENNIAL ALLERGIC RHINITIS,
PRURITIS, AND CHRONIC IDIOPATHIC URTICARIA IN PATIENTS 2 YEARS OF AGE AND OLDER
TREATMENT OF SEASONAL ALLERGY SYMPTOMS WITH NASAL CONGESTION IN ADULTS AND
CHILDREN 12 YEARS OF AGE AND OLDER
REDUCTION OF SERUM PHOSPHATE
TREATMENT OF SEXUAL DYSFUNCTION
ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TOTAL-C, TRIGLYCERIDES AND
APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED
DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
MANAGEMENT OF PERSISTENT, MODERATE TO SEVERE PAIN IN PATIENTS REQUIRING
CONTINUOUS, AROUND-THE-CLOCK ANALGESIA WITH A HIGH POTENCY OPIOID FOR AN EXTENDED
PERIOD OF TIME GENERALLY WEEKS TO MONTHS OR LONGER
TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)
USE OF ROSUVASTATIN CALCIUM TO REDUCE ELEVATED TOTAL-C, LDL-C, APOB, NONHDL-C OR
TG LEVELS; TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR
MIXED DYSLIPIDEMIA; AND TO SLOW THE PROGRESSION OF ATHEROSCLEROSIS.
TREATMENT OF MALIGNANT NEOPLASM
TREATMENT OF INSOMNIA
METHOD OF TREATING CANCER
TREATMENT OF VEGF MEDIATED OCULAR DISEASE.
SHORT TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
REDUCTION OF RISK OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
ALLERGIC RHINITIS OR NASAL POLYPS
CLOLAR IS INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 TO 21 YEARS OLD WITH
RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA AFTER AT LEAST TWO PRIOR
REGIMENS
TREATMENT OF PATIENTS USING EXTENDED-RELEASE CARBAMAZEPINE
USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA, AND IN COMBINATION WITH
METFORMIN AND A SULFONYLUREA TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES MELLITUS
METHOD OF INDUCING A HYPNOTIC OR SEDATIVE EFFECT IN A HUMAN BY ADMINISTERING
ESZOPICLONE
TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF
DARIFENACIN
TREATING A DISEASE OF ALTERED MOTILITY OR TONE OF SMOOTH MUSCLE BY ADMINISTERING A
MUSCARINIC RECEPTOR ANTAGONIZING AMOUNT OF DARIFENACIN
METHOD OF TREATMENT OF CANCER BY ADMINISTERING PARTICLES OF PACLITAXEL THAT HAVE A
PROTEIN COATING
METHOD FOR TREATMENT OF TUMORS BY ADMINISTERING PACLITAXEL AT A DOSE IN THE RANGE
OF ABOUT 30MG/METER SQUARE TO ABOUT 100MG/METER SQUARE IN A PHARMACEUTICALLY
ACCEPTABLE FORMULATION THAT DOES NOT CONTAIN CREMOPHOR
METHOD FOR DELIVERY OF A BIOLOGIC (INCLUDING ANTINEOPLASTIC AGENTS) BY
ADMINISTERING TO A PATIENT AN EFFECTIVE AMOUNT OF A BIOLOGIC AS A SOLID OR LIQUID
WITH A POLYMERIC BIOCOMPATIBLE MATERIAL
TREATMENT OF GERD, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND RISK
REDUCTION OF NSAID ASSOCIATED GASTRIC ULCERS
TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS
TREATMENT OF DIABETES WITH AN AMYLIN AGONIST
TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN
TREATMENT OF A MAMMAL HAVING A NEED OF OR REDUCED ABILITY TO PRODUCE INSULIN WITH
AN INSULIN AND AN AMYLIN SUCH AS PRAMLINTIDE
USE OF AN AMYLIN AGONIST TO REDUCE GASTRIC MOTILITY AND TREAT POST PRANDIAL
HYPERGYLCEMIA
USE OF AN AMYLIN AGONIST HAVING SPECIFIED BINDING ACTIVITY TO REDUCE GASTRIC
MOTILITY, INCLUDING USE THROUGH PARENTERAL ADMINISTRATION

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PATENT AND EXCLUSIVITY TERMS

ADB 44 of 73

PATENT USE
U-642
U-643

U-644
U-645
U-646
U-647
U-648
U-649
U-650
U-651
U-652
U-653
U-654
U-655

U-656
U-657
U-658
U-659
U-660
U-661
U-662
U-663
U-664
U-665
U-666
U-667
U-668
U-669
U-670
U-671
U-672
U-673
U-674
U-675
U-676
U-677
U-678
U-679
U-680

U-681
U-682
U-683
U-684
U-685

TREATMENT AND PREVENTION OF OSTEOPOROSIS

THE SHORT TERM TREATMENT (UP TO 10 DAYS) IN PTS HAVING GASTROESOPHAGEAL REFLUX
DISEASE (GERD) AS AN ALTERNATIVE TO ORAL THERAPY IN PTS WHEN THERAPY WITH NEXIUM
CAPSULES IS NOT POSSIBLE OR APPROPRIATE
TREATMENT OF SEASONAL ALLERGIC RHINITIS
TREATMENT OF ASTHMA
METHOD OF TREATING OTITIS
TREATMENT OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN AND/OR THE TREATMENT TO
INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND/OR THE TREATMENT TO
INCREASE BONE MASS IN MEN
A METHOD FOR TREATING A TUMOR DISEASE
TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT
PATIENTS
TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL)
TREATMENT OF CARDIAC ARRHYTHMIA
STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2
DIABETES, BY ADMINISTERING AN EXEDIN OR ANALOG, SUCH AS EXENDIN-4
TREATMENT OF MILD TO MODERATE ACTIVE CHROHN'S DISEASE INVOLVING THE ILEUM AND/OR
THE ASCENDING COLON AND THE MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE
CROHN'S DISEASE INVOLVING THE ILEUM AND/OR ASCENDING COLON FOR UP TO 3 MONTHS
REDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN
EXENDIN, SUCH AS EXENDIN-4
PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
TREATMENT OF ADVANCED HORMONE-DEPENDENT BREAST CANCER
TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC)
AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
TREATMENT OF HYPERTENSION AND TREATMENT OF HEART FAILURE
TREATMENT OF SEIZURE DISORDER
TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED,
SUCH AS HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION
METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
METHOD OF TREATING ADHD
MANAGEMENT OF INCONTINENCE; METHOD FOR TREATING INCONTINENCE
LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT
OF PATIENTS WITH DIABETES MELLITUS
INDICATION OF TYPE II DIABETES
TREATMENT OF HIV-1 INFECTION BY THE CO-ADMINISTRATION OF TIPRANAVIR AND RITONAVIR.
PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
KIDNEY DISEASE (CKD) STAGE 3 AND 4
TREATMENT OF INFLAMMATION OR AN INFLAMMATION-ASSOCIATED DISORDER
METHOD OF TREATMENT WITH ONCE-DAILY DOSES OF 625MG/5ML
METHOD OF TREATING INSOMNIA CHARACHTERIZED BY DIFFICULTY WITH SLEEP ONSET
PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA; RELIEF OF SYMPTOMS OF ALLERGIC
RHINITIS
METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BIMODAL OR PULSATILE RELEASE COMPOSITION
A METHOD OF TREATING DISEASE AMENABLE TO TREATMENT WITH A PHENIDATE DRUG BY ONCE
DAILY ORAL ADMINISTRATION OF AN EXTENDED RELEASE DOSAGE FORM
METHOD OF TREATING ATTENTION DEFICIT DISORDER AND/OR ATTENTION DEFICIT
HYPERACTIVITY DISORDER
ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT
CAN PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE
WHICH IS AT LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM
TREATMENT OF PRIMARY IGF-1 DEFICIENCY
NON-BENZODIAZEPINE HYPNOTIC AGENT INDICATED FOR TREATMENT OF INSOMNIA,
CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
PREVENTION OR TREATMENT OF ISCHEMIC HEART DISEASE
TREATMENT OF UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN
ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER
EXPECTORANT AND COUGH SUPPRESSANT

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PATENT AND EXCLUSIVITY TERMS

ADB 45 of 73

PATENT USE
U-686
U-687
U-688
U-689

U-690
U-691

U-692

U-693

U-694

U-695

U-696

U-697
U-698
U-699
U-700
U-701
U-702
U-703
U-704
U-705
U-706
U-707
U-708
U-709
U-710

U-711
U-712
U-713
U-714
U-715
U-716

U-717
U-718
U-719
U-720
U-721
U-722
U-723
U-724
U-725

EXPECTORANT AND NASAL DECONGESTANT

REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN
EXENDIN, SUCH AS EXENDIN-4
TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA WHOSE DISEASE HAS
NOT RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO
CHEMOTHERAPY REGIMENS
TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
USE AS A MONOTHERAPY, IN COMBINATION WITH A SULFONYLUREA, METFORMIN OR INSULIN OR
IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN TO IMPROVE GLYCEMIC CONTROL IN
PATIENTS WITH TYPE 2 DIABETES MELLITUS
USE OF VALSARTAN TO REDUCE CARDIOVASCULAR MORTALITY IN CLINICALLY STABLE PATIENTS
WITH LEFT VENTRICULAR FAILURE OR LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL
INFARCTION
THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE
DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL
CLINICAL RESPONSE.
LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN
THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF LENALIDOMIDE IS TAKEN
DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY.
TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA AND T-CELL
LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT RESPONDED TO OR HAS RELAPSED
FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS
TREATMENT OF PATIENTS WITH T-CELL LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT
RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY
REGIMENS
A METHOD OF USING RINFABATE RECOMBINANT (RHIGFBP-3) WITH MECASERMIN RECOMBINANT
(RHIGF-1) TO PROMOTE LINEAR GROWTH IN THE TRATMENT OF PRIMARY IGF-1 DEFICIENCY
METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR
INTRAVENOUS TREATMENT OF PATEINTS WITH EUVOLEMIC HYPONATREMIA
NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
TREATMENT OF HYPERCHOLESTEROLEMIA AND/OR HYPERTRIGLYCERIDEMIA
TOPICAL AEROSOL HAIR REGROWTH TREATMENT
TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL
TUMOR AND RENAL CELL CARCINOMA WITH SUNITINIB
METHOD OF ADMINISTERING INSULIN VIA INHALATION
TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
ALLERGIC RHINITIS
TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE
EYE
METHOD OF COMBATING BACTERIA IN A PATIENT
A METHOD OF TREATING RESPIRATORY DISORDERS, E.G., ASTHMA, WHICH COMPRISES
ADMINISTRATION BY INHALATION OF AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL
FORMULATION AS CLAIMED IN US PATENT NO. 5658549
ACUTE AND LONGER-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
A METHOD OF USING A NICOTINIC ACID FORMULATION TO REDUCE ELEVATED TC, LDL-C AND TG
LEVELS, AND RAISE HDL-C LEVELS IN PATIENTS WITH HYPERLIPIDEMIA
TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE
TOPICAL TREATMENT OF INTERDIGITAL TINEA PEDIS AND TINEA CORPORIS DUE TO
TRICHOPHYTON RUBRUM, TRICHOPHYTON MENTAGROPHYTES OR EPIDERMOPHYTON FLOCCOSUM
FOR CLEANSING THE BOWEL IN PREPARATION FOR COLONOSCOPY, IN ADULTS 18 YEARS OF AGE
OR OLDER
THE TREATMENT OR PREVENTION OF BRONCHOSPASM IN ADULTS AND CHILDREN 4 YEARS OF AGE
AND OLDER WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE AND THE PREVENTION OF
EXERCISED-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
TREATMENT OF FUNGAL INFECTIONS
TREATENT OF PSYCHOSIS
TREATMENT OF NEUROLEPTIC DISEASES
TREATMENT OF INFLUENZA
PROPHYLAXIS OF INFLUENZA
PROPHYLACTIC TREATMENT OF MIGRAINE
METHOD OF TREATING SEIZURES
ALLERGIC RHINITIS AND URTICARIA

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PATENT AND EXCLUSIVITY TERMS

ADB 46 of 73

PATENT USE
U-726
U-727
U-728
U-729

U-730
U-731
U-732
U-733
U-734
U-735
U-736
U-737
U-738
U-739
U-740
U-741
U-742
U-743
U-744
U-745
U-746
U-747
U-748
U-749
U-750
U-751
U-752
U-753
U-754
U-755
U-756
U-757
U-758
U-759
U-760
U-761
U-762
U-763
U-764
U-765
U-766
U-767
U-768

U-769

U-770
U-771
U-772

ALLERGIC RHINITIS
FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
METHOD FOR TREATING BACTERIAL INFECTION
TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), RISK-REDUCTION OF NSAIDASSOCIATED GASTRIC ULCER, H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL
ULCER RECURRENCE
USE AS A NASAL SPRAY FOR TREATMENT OF THE SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
AND VASOMOTOR RHINITIS
USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA
NODOSUM LEPROSUM (ENL)
MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS
OF ENL RECURRENCE
FIRST LINE THERAPY FOR TYPE 2 DIABETES MELLITUS
METHOD OF TREATING CHRONIC IRON OVERLOAD
METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
INDICATED FOR THE LONG-TERM, TWICE-DAILY MAINTENANCE TREATMENT OF ASTHMA IN
PATIENTS 12 YEARS OF AGE OR OLDER
METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMALIAN SUBJECT
FOR THE TREATMENT OF PATIENTS WITH PRIMARY BILIARY CIRRHOSIS
COMBINATION THERAPY WITH CISPLATIN FOR THE TREATMENT OF LATE STAGE CERVICAL CANCER
TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.
ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
TREATMENT OF HIV INFECTION IN ANTIRETROVIRAL TREATMENT-EXPERIENCED ADULT PATIENTS
TREATMENT OR PREVENTION OF EMESIS
PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC
AGENT
PREVENTION OR TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER
METHOD OF CONTRACEPTION
TREATMENT OF HIV-1 INFECTION IN ADULTS
ONCE DAILY DOSING OF BUDESONIDE VIA NEBULIZER FOR THE TREATMENT OF ASTHMA
SUNSCREEN
AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH
TYPE 2 DIABETES
USE FOR THE LONG-TERM MAINTENANCE TREATMENT OF ASTHMA
TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN
PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
TREATMENT OF SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER
METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF
OROPHARYNGEAL CANDIDAIASIS
TREATMENT OF SCHIZOPHRENIA INCLUDING MAINTAINING STABILITY IN PATIENTS WITH
SCHIZOPHRENIA
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
ADMINISTRATION OF ARIPIPRAZOLE BY INJECTION
TREATMENT OF SCHIZOPHRENIA
METHOD OF TREATING ALLERGIC CONJUNCTIVITIS
TREATMENT OF SEIZURES
MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A
FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR
TO THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID
REVLIMID (LENALIDOMIDE) IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE
TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEASET ONE PRIOR
THERAPY
LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS
METHOD FOR THE TREATMENT OF DIABETES MELLITUS, SUCH AS TYPE 1 DIABETES MELLITUS OR
TYPE 2 DIABETES MELITUS, IN A HUMAN PATIENT
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN CHILDREN 2 TO 11
YEARS AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH UNCOMPLICATED SKIN

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 47 of 73

PATENT USE

U-773
U-774
U-775
U-776

U-777
U-778
U-779
U-780
U-781
U-782

U-783
U-784
U-785
U-786
U-787

U-788
U-789
U-790

U-791
U-792
U-793

U-794

U-795
U-796
U-797
U-798

U-799
U-800

U-801
U-802
U-803
U-804
U-805
U-806
U-807
U-808
U-809
U-810

MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN CHILDREN 6 MONTHS TO 11 YEARS

PATHOLOGICAL HYPERSECRETORY CONDITIONS
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASTE-IV INHIBITOR
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
TREATMENT OF CUTANEOUS MANIFESTATION IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA
(CTCL) WHO HAVE PROGRESSIVE, PERSISTENT OR RECURRENT DISEASE ON OR FOLLOWING TWO
SYSTEMIC THERAPIES.
DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATEINTS WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
A METHOD FOR TREATMENT OF A CANCER, WHEREIN THE CANCER IS CHRONIC MYELOGENOUS
LEUKEMIA
A METHOD FOR THE TREATMENT OF CANCER
FOR TREATMENT OF ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE NAIVE TO
PHARMACOLOGIC THERAPY
TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL
REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM
AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
DESONATE GEL IS INDICATED FOR THE TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS
IN PATIENTS 3 MONTHS OF AGE AND OLDER
TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION
IN CONTINUOUS RENAL REPLACEMENT THERAPY
PRODUCT IS APPROVED FOR THE TOPICAL TREATMENT OF TINEA PEDIS
MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND PEDIATRIC
PATIENTS SIX YEARS OF AGE OR OLDER, INCLUDING PATIENTS REQUIRING ORAL
CORTICOSTEROID THERAPY FOR ASTHMA
METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS
USING PAROXETINE
TREATMENT OF KNOWN OR SUSPECTED CYANIDE POISONING
FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS
WHO ARE AT RISK FOR FRACTURE. FORTEO CAN BE USED BY PEOPLE WHO HAVE HAD A FRACTURE
RELATED TO OSTEOPOROSIS
GLEEVEC IS ALSO INDICATED FOR THE TREATMENT OF PATIENTS WITH KIT (CD117) POSITIVE
UNRESECTABLE AND/OR METASTATIC MALIGNANT GASTROINTESTINAL STROMAL TUMORS (GIST)
TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
FOR THE LONG TERM TREATMENT, TWICE DAILY (MORNING AND EVENING) MAINTENANCE
TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY
DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS
WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN
USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
METHOD FOR INHIBITING NOREPINEPHRINE UPTAKE
METHOD OF TREATING DEPRESSION
METHOD OF TREATING ANXIETY
TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY
ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF
IBANDRONIC ACID
METHOD FOR INHIBITING SEROTONIN UPTAKE
TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS
OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A
TAXANE AND TRASTUZUMAB
METHOD OF TREATING CANCER
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY
TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
INTRATHECAL TREATMENT OF LYMPHOMATOUS MENINGITIS
PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION
THE TREATMENT OF THE SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN
PATIENTS 2 YEARS OF AGE AND OLDER
TREATMENT OF CHRONIC IDIOPATHIC URTICARIA
METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE

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PATENT AND EXCLUSIVITY TERMS

ADB 48 of 73

PATENT USE
U-811
U-812
U-813
U-814
U-815
U-816
U-817
U-818
U-819
U-820

U-821
U-822
U-823

U-824
U-825
U-826
U-827
U-828
U-829
U-830
U-831
U-832
U-833

U-834
U-835
U-836
U-837
U-838
U-839
U-840
U-841
U-842
U-843
U-844

U-845
U-846
U-847

U-848
U-849

U-850
U-851

RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS AND
TREATMENT OF THE UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE
PULMONARY DISEASE (COPD)
TREATMENT OF SCHIZOPHRENIA
TREATS COLD SORES/FEVER BLISTERS ON THE FACE OR LIPS. SHORTENS HEALING TIME AND
DURATION OF SYMPTOMS: TINGLING, PAIN, BURNING AND/OR ITCHING
DEPRESSION, PANIC DISORDER, PREMENSTRUAL DISORDERS AND SOCIAL ANXIETY DISORDER
NASAL ADMINISTRATION OF CYANOCOBALAMIN
TOPICAL TREATMENT OF ACNE VULGARIS
MANAGEMENT OF FIBROMYALGIA
IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE SLEEPINESS ASSOCIATED WITH
NARCOLEPSY, OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME, AND SHIFT WORK SLEEP
DISORDER
METHOD OF INHIBITING ENTHOTHELIN RECEPTORS BY ADMINISTERING AMBRISENTAN TO A
PATIENT TO TREAT PULMONARY ARTERIAL HYPERTENSION.
USE IN LIPID MANAGEMENT
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS AND FOR THE
TREATMENT OF UNCOMPLCATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN
CHILDREN 6 TO 11 YEARS OF AGE
METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
USE FOR PREVENTION OF BREAST CANCER
RELIEF OF MODERATE TO SEVERE PAIN
USE FOR TREATMENT OF DIABETES, PARTICULARLY TYPE 2 DIABETES
PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD
OF CONTRACEPTION
TREATMENT OF EXTRAVASATION RESULTING FROM IV ANTHRACYCLINE CHEMOTHERAPY
TREATMENT OF RELAPSED SMALL CELL LUNG CANCER
METHOD OF ADMINISTERING LANREOTIDE ACETATE
ZINGO IS INDICATED FOR THE USE ON INTACT SKIN TO PROVIDE LOCAL ANALGESIA PRIOR TO
VENIPUNCTURE OR INTRAVENOUS CANNULATION.
METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE
AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.25% BY WEIGHT OF
ROPIVACAINE
INVIRASE IN COMBINATION WITH RITONAVIR AND OTHER ANTIRETROVIRAL AGENTS IS
INDICATED FOR THE TREATMENT OF HIV INFECTION
RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF ATOPIC DERMATITIS IN
PATIENTS ONE YEAR OF AGE OR OLDER
A METHOD FOR THE TREATMENT OF LEUKEMIAS
GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A PREPARATION FOR
COLONOSCOPY IN ADULTS
METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE
AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.5% BY WEIGHT OF ROPIVACAINE
TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
TREATMENT FOR TYPE 2 DIABETES MELLITUS
INDICATED FOR THE LONG-TERM, MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS
OF AGE AND OLDER
INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
METHOD FOR ADMINISTRATION OF TESTOSTERONE
PREFEST IS INDICATED IN WOMEN WHO HAVE A UTERUS FOR THE TREATMENT OF MODERATE TO
SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE; TREATMENT OF VULVAR AND
VAGINAL ATROPHY; PREVENTION OF OSTEOPOROSIS
TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA
PERITONITIS AND ABCESSES
USE FOR DELINEATION (VISUALIZATION) DURING A VITRECTOMY SURGICAL PROCEDURE
ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TRIGLYCERIDES AND APO B, AND
INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA
(TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR
OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO
INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE
TWICE DAILY
PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC
AGENT
TREATMENT OF TYPE 2 DIABETES MELLITUS

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 49 of 73

PATENT USE

U-852
U-853
U-854
U-855
U-856

U-857
U-858
U-859

U-860
U-861
U-862

U-863

U-864
U-865
U-866
U-867
U-868
U-869
U-870
U-871
U-872

U-873
U-874
U-875
U-876
U-877
U-878
U-879
U-880

U-881
U-882
U-883
U-884
U-885
U-886
U-887
U-888
U-889
U-890
U-891
U-892
U-893

RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS

TREATMENT OR PREVENTION OF EMESIS

PREVENTION OF CMV DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT

PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)

METHOD TO INDUCE NATRIURESIS, DIURESIS AND/OR VASODILATION

SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS

LUTEAL FUNCTION AS PART OF AN ASSISTED REPORDUCTIVE TECHNOLOGY (ART) TREATMENT

PROGRAM FOR INFERTILE WOMEN

INHIBITION OF TRANSPLANT REJECTION

PEDIATRIC USE AGED 1-11 YEARS, GERD AND EROSIVE ESOPHAGITIS

EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON

SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS

IN PATIENTS WITH GERD

FOR THE APPROVED USES AND CONDITIONS OF USE, INCLUDING DEPRESSION

RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID

RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER

ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A)

LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED

DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA

TAKING ASPIRIN OR NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS APPROXIMATELY 30

MINUTES BEFORE DOSING CAN MINIMIZE FLUSHING, A COMMON SIDE EFFECT OF NIACIN

THERAPY

PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS

TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND A HIGH RISK FOR BONE FRACTURE BY

REDUCING THE RISK OF VERTEBRAL AND NONVERTEBRAL BONE FRACTURE

THE LABEL REFERENCES THE EFFECTS OF THE ACTIVE INGREDIENT OF REVLIMID UPON

CYTOKINES

TREATMENT OF MIGRAINE

METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR

INTRAVENOUS TREATMENT OF PATIENTS WITH HYPERVOLEMIC HYPONATREMIA

METHOD FOR STIMULATING CORONOARY VASODILATION FOR PURPOSES OF IMAGING THE HEART

METHOD OF PRODUCING CORONARY VASODILATION WITHOUT PERIPHERAL VASODILATION

METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH

TWICE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC

OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA.

TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS

METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY

OPENING CHLORIDE CHANNELS (CIC)

METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME

FIRST-LINE TREATMENT OF LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC

CANCER, IN COMBINATION WITH GEMCITABINE

TREATMENT OF MIGRAINE WITH OR WITHOUT AURA

FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PEPTIC ULCER

A METHOD FOR BINDING A PERIPHERAL OPIOID RECEPTOR

A METHOD OF TREATING OR PREVENTING ILEUS

ENDOMETRIN IS A PROGESTERONE INDICATED TO SUPPORT EMBRYO IMPLANTATION AND EARLY

PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED

REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN

TREATMENT OF NON-SMALL CELL LUNG CANCER

MANAGEMENT OF FIBROMYALGIA (FM)

TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB

TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA

TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR

THERAPY

ADMINISTERING DESLORATADINE TO TREAT THE SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS,

SEASONAL ALLERGIC RHINITIS, OR CHRONIC IDIOPATHIC URTICARIA

TREATMENT AND PREVENTION OF OSTEOPOROSIS

FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN

MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCCIATED

WITH MENOPAUSE)

REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE

USE AS AN INTRAOCULAR IRRIGATING SOLUTION DURING SURGICAL PROCEDURES INVOLVING

PERFUSION OF THE EYE

TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA

(CTCL)

CLEVIPREX IS A DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER INDICATED FOR THE REDUCTION

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 50 of 73

PATENT USE

U-894
U-895
U-896
U-897
U-898
U-899
U-900
U-901
U-902
U-903
U-904
U-905
U-906

U-907
U-908
U-909
U-910
U-911

U-912
U-913
U-914
U-915
U-916
U-917
U-918
U-919
U-920

U-921
U-922
U-923
U-924
U-925
U-926

U-927
U-928
U-929
U-930
U-931
U-932

U-933

U-934

OF BLOOD PRESSURE WHEN ORAL THERAPY IS NOT FEASIBLE OR NOT DESIRABLE

TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS
AND CHILDREN TWO YEARS OF AGE AND OLDER
METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS
PYOGENES IN A ONCE-A-DAY AMOXICILLIN PRODUCT
USE OF GLUTAMINE TOGETHER WITH GROWTH HORMONE FOR THE TREATMENT OF PATIENTS WITH
SHORT BOWEL SYNDROME
USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION
PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
USE IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA
(BPH)
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN ADULT PATIENTS
TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE,
SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY, LIVER AND HEART ALLOGENIC TRANSPLANTS;
TREATMENT OF PATIENTS WITH SEVERE ACTIVE, RHEUMATOID ARTHRITIS; TREATMENT OF
ADULT, NONIMMUNOCOMPROMISED PATIENTS WITH SEVERE, RECALCITRANT, PLAQUE PSORIASIS
FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS IN SUBJECTS 18 YEARS OF AGE
AND OLDER
PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING ALLOGENEIC RENAL TRANSPLANTS
TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR
SUBSEQUENT CHEMOTHERAPY
METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT
WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL TREATMENT IS TEMPORARILY NOT
FEASIBLE
SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER
PROCEDURES
TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE,
URGENCY, AND FREQUENCY
METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT
WITH EPILEPSY AGED 17 YEARS AND OLDER
TREATMENT OF MUSCULOSKELETAL CONDITIONS
TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYEDRELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
FOR THE TREATMENT OF DERMATITIS
STEROID-RESPONSIVE INFLAMMATORY OCULAR CONDITIONS FOR WHICH A CORTICOSTEROID IS
INDICATED AND WHERE SUPERFICIAL BACTERIAL OCULAR INFECTION OR A RISK OF BACTERIAL
OCULAR INFECTION EXISTS
TREATMENT OF ACNE VULGARIS
FOR THE TREATMENT OF FUNGAL INFECTIONS
METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS
TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA
OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING
PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)
METHOD FOR INCREASING TEAR PRODUCTION
TREATMENT OF BACTERIAL INFECTIOUS DISEASE
TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI
TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
RELIEF OF MODERATE TO SEVERE ACUTE PAIN
PYLERA CAPSULES, IN COMBINATION WITH OMEPRAZOLE ARE INDICATED FOR THE TREATMENT OF
PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO
ERADICATE H. PYLORI
FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL
ULCER DISEASE TO ERADICATE H. PYLORI. THE ERADICATION OF HELICOBACTER PYLORI HAS
BEEN SHOWN TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 51 of 73

PATENT USE

U-935

U-936

U-937
U-938
U-939
U-940
U-941
U-942
U-943
U-944
U-945
U-946
U-947

U-948
U-949
U-950
U-951
U-952
U-953
U-954
U-955
U-956
U-957
U-958

U-959

U-960
U-961

U-962
U-963
U-964
U-965
U-966
U-967

U-968
U-969
U-970
U-971
U-972

HEMATOPOIETIC STEM CELL TO THE PERIPHERAL BLOOD FOR COLLECTION AND SUBSEQUENT
AUTOLOGOUS TRANSPLANTATION WITH NON-HODGKINS LYMPHOMA AND MULTIPLE MYELOMA
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF
AGE AND OLDER
USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE
HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT
AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE
MYELOMA
TREATMENT OF PROSTATE CANCER
TREATMENT OF HAIR LOSS AND HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR
GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS
TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING AND STIMULATING THEIR
GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS
METHOD TO TREAT AIDS-RELATED KAPOSI'S SARCOMA
METHOD TO TREAT OVARIAN CANCER
METHOD TO TREAT MULTIPLE MYELOMA
GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER
TREATMENT OF PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
SEDATIVE-HYPNOTIC AGENT INDICATED FOR MONITORED ANESTHESIA CARE (MAC) SEDATION
TREATMENT OF BREAST CANCER
WHEN PATIENTS ARE UNABLE TO TAKE THE ORAL FORMULATIONS, PREVACID IV, FOR INJECTION
IS INDICATED AS AN ALTERNATIVE FOR THE SHORT-TERM TREATMENT (UP TO 7 DAYS) OF ALL
GRADES OF EROSIVE ESOPHAGITIS
TREATMENT OF DIABETES MELLITUS
HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
(GERD) FOR 4 WEEKS
USE AS AN ANALGESIC
METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE
TREATMENT OF ASYMPTOMATIC HYPERURICEMIA
PROPHYLACTIC TREATMENT OF MIGRAINE
TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE
A METHOD OF TREATING CANCER IN A PATIENT COMPRISING ADMINISTERING IXABEPILONE OR
PHARMACEUTICAL COMPOSITIONS COMPRISING IXABEPILONE
METHOD OF TREATING PATIENT COMPRISING MIXING FIRST AND SECOND VIALS OF PRODUCT
COMPRISING LYOPHILIZED IXABEPILONE TO PROVIDE AN EPOTHILONE ANALOG SOLUTION,
DILUTING SOLUTION WITH A SUITABLE DILUENT TO PREPARE INTRAVENOUS FORMULATION FOR
PT
METHOD OF TREATING CANCER, IV ADMIN, LYOPHYLIZED IXABEPILONE DILUTED, EVERY WEEK
OR 3 WEEKS; LYOPHILIZED IXABEPILONE WITH SOLVENT(DEHYDRATED ETHANOL) DILUTED TO
CONCENTRATION OF 0.1MG/ML TO 0.9MG/ML
METHOD OF TREATING CANCER IN A PATIENT COMPRISING INTRAVENOUSLY ADMINISTERING TO
THE PATIENT IXABEPILONE DILUTED IN A PARENTERAL DILUENT
METHOD OF TREATING BREAST CANCER BY ADMINISTERING IXABEPILONE; A METHOD OF
TREATING A CANCER RESPONSIBLE TO MICROTUBULE STABILIZATION BY ADMINISTERING
IXABEPILONE
SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN
ADULTS
PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT
RESISTANT DEPRESSION IN ADULTS
ZYPREXA ZYDIS AND FLUOXETINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT
RESISTANT DEPRESSION IN ADULTS
USE OF IXABEPILONE IN COMBINATION WITH CAPECITABINE IN TREATMENT OF METASTASIS
BREAST CANCER
TREATMENT OF ASTHMA (MAINTENANCE AND PROPHYLACTIC THERAPY)
A METHOD OF REVERSING SOFT-TISSUE ANESTHESIA I.E. ANESTHESIA OF THE LIP AND
TONGUE, AND THE ASSOCIATED FUNCTIONAL DEFICITS RESULTING FROM AN INTRAORAL
SUBMUCOSAL INJECTION OF A LOCAL ANESTHETIC
A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
TREATMENT OF MIGRAINE
TOPICAL TREATMENT OF LICE INFESTATIONS
INDICATED FOR THE ACUTE TREATMENT OF ADULTS WITH SCHIZOPHRENIA
MONOTHERAPY OR AS ADJUNCTIVE THERAPY TO LITHIUM OR VALPROATE FOR THE MAINTENANCE
TREATMENT OF BIPOLAR I DISORDER

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 52 of 73

PATENT USE
U-973

U-974
U-975
U-976
U-977
U-978
U-979
U-980
U-981

U-982
U-983
U-984
U-985
U-986
U-987
U-988
U-989
U-990
U-991
U-992
U-993
U-994
U-995
U-996

U-997
U-998

U-999
U-1000
U-1001

U-1002
U-1003
U-1004
U-1005
U-1006

U-1007
U-1008
U-1009
U-1010

U-1011
U-1012
U-1013

ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO
HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
TREATMENT OF PULMONARY HYPERTENSION
IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
TREATMENT OF ACUTE, UNCOMPLICATED MALARIA INFECTION DUE TO PLASMODIUM FALCIPARUM
IN PATIENTS OF 5KG BODYWEIGHT AND ABOVE
METHOD OF TREATING HYPONATREMIA
RELIEF OF MUSCLE SPASM
NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN
ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY,
ANALGESIC, AND ANTIPYRETIC ACTIVITY
A METHOD OF TREATING OSTEOPOROSIS
METHOD OF TREATING OSTEOPOROSIS IN A POST-MENOPAUSAL WOMAN AT RISK FOR FRACTURE
METHOD FOR THE TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND AT RISK FOR BONE
FRACTURE
TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR
CENTRAL RETINAL VEIN OCCLUSION (CRVO)
TREATMENT OF PATIENTS INFECTED WITH PEDICULUS HUMANUS CAPITIS (HEAD LICE AND THEIR
OVA) OF THE SCALP HAIR
TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH CHRONIC KIDNEY DISEASE
ON DIALYSIS
TREATMENT OF RHINITIS COMPRISING THE NASAL APPLICATION OF A PHARMACEUTICAL
FORMULATION AS CLAIMED IN US PATENT 7541350
FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM
HYPERPHENYLALANINEMIA
TREATMENT OF PROTOZOAL INFECTION
TREATMENT OR PROPHYLAXIS OF THROMBOSIS OR EMBOLISMS
REDUCTION OF THE RISK OF CARDIOVASCULAR HOSPITALIZATION
METHOD OF TREATING INFERTILITY
METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED
METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
AN ADJUNCTIVE THERAPY TO DIET TO REDUCT ELEVATED TOTAL CHLORESTEROL (TC), LOWDENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPROTEIN B, TRIGLYCERIDES, AND TO INCREASE
HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIX DYSLIPIDEMIA
TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY
LIPOPROTEIN CHOLESTEROL, APOLIPOPRTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN
ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
METHOD FOR DELIVERING DRUG TO LUNG OF MAMMAL, COMPRISING ADMINISTERING DRUG
PRODUCT BY INHALATION. TREATING A MAMMAL HAVING A CONDITION CAPABLE OF TREATMENT
BY INHALATION, COMPRISING ADMINISTERING TO THE LUNG THE DRUG PRODUCT BY INHALATION
METHOD OF TREATING INFLAMMATORY CONDITIONS
A METHOD OF MYOCARDIAL PERFUSION IMAGING AND INCREASING CORONARY BLOOD FLOW
TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
METHOD OF TREATING A STAPHYLOCOCCAL INFECTION
NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD
SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION
HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)
METHOD OF TREATING GOUT FLARES
APPLICATION OF ANTISEPTIC WITH MOISTURIZERS FOR SURGICAL AND HEALTHCARE PERSONNEL
SKIN DISINFECTION
METHOD FOR ADMINISTRATION OF TESTOSTERONE
TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO
TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH
FOOD TO INCREASE ABSORPTION
USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA
AND VOMITING
METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG
INTERACTION
METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 53 of 73

PATENT USE

U-1014
U-1015
U-1016

U-1017
U-1018
U-1019
U-1020
U-1021
U-1022
U-1023
U-1024

U-1025
U-1026
U-1027
U-1028
U-1029
U-1030
U-1031
U-1032

U-1033
U-1034
U-1035
U-1036
U-1037
U-1038
U-1039
U-1040
U-1041
U-1042
U-1043
U-1044
U-1045
U-1046
U-1047
U-1048
U-1049
U-1050
U-1051
U-1052
U-1053
U-1054
U-1055

TREAT PATIENTS WITH CHRONIC HEPATITIS C

METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND
NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1
INFECTION IN TREATMENT-EXPERIENCED ADULT PATIENTS, WHO HAVE EVIDENCE OF VIRAL
REPLICATION AND HIV-1 STRAINS RESISTANT TO AN NNRTI AND OTHER ANTIRETROVIRAL
AGENTS
A METHOD OF TREATING NASAL AND NON-NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
TREATMENT OF PULMONARY HYPERTENSION BY INHALATION
TREATMENT OF PULMONARY HYPERTENSION
METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
SHORT-TERM TREATMENT (4-8 WEEKS) OF ACTIVE BENIGN GASTRIC ULCER
FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN
POTENTIALLY CAUSE SKIN INFECTION
TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR
HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY
CONTROLLED IOP
TREATING FREQUENT HEARTBURN
A METHOD OF TREATING HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS.
REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
A METHOD OF DISTRIBUTING SODIUM OXYBATE UNDER CONTROL OF A CENTRAL PHARMACY
METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED
THEREOF
IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS
AERUGINOSA
USE OF ROSUVASTATIN CALCIUM FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE
IN INDIVIDUALS WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH
INCREASED RISK FACTORS
TOPICAL TREATMENT OF ACNE VULGARIS
TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS
NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN
INHIBITION OF THROMBIN IN A PATIENT
TREATMENT OF DISORDERS RESPONSIVE TO GROWTH HORMONE
METHOD FOR STIMULATING CORONARY VASODILATION FOR PURPOSES OF IMAGING THE HEART
MANAGEMENT OF MODERATE TO SEVERE PAIN
TOPICAL TREATMENT OF SCALP PSORIASIS
MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHO
HAVE NOT PROGRESSED ON 1ST-LINE TREATMENT WTH PLATINUM-BASED CHEMOTHERAPY
MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHOSE
DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES PLATINUM-BASED CHEMOTHERAPY
TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA (SBCC)
WORKS THROUGH THE INDUCTION OF INTERFERON AND OTHER CYTOKINES
PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS AT LOW-MODERATE IMMUNOLOGIC RISK
RECEIVING A RENAL TRANSPLANT
USE OF METAXALONE FOR TREATMENT OF MUSCULSKELETAL CONDITIONS
TREATMENT OF OROPHARYNGEAL CANDIDIASIS
RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED
GASTRIC ULCER
RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON
MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHO ARE ALREADY TREATED WITH A THIAZOLIDINEDIONE (TZD) AND
METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A TZD OR METFORMIN ALONE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 54 of 73

PATENT USE
U-1056
U-1057
U-1058
U-1059
U-1060
U-1061
U-1062
U-1063
U-1064
U-1065

U-1066

U-1067
U-1068
U-1069
U-1070

U-1071
U-1072
U-1073
U-1074
U-1075
U-1076
U-1077
U-1078
U-1079
U-1080
U-1081
U-1082
U-1083
U-1084
U-1085
U-1086
U-1087
U-1088
U-1089
U-1090
U-1091
U-1092
U-1093
U-1094
U-1095
U-1096
U-1097

U-1098

TREATMENT OF PAIN USING A NASAL SPRAY OF KETOROLAC TROMETHAMINE

TREATMENT OF INFLAMMATION AND PAIN USING A NASAL SPRAY OF KETOROLAC TROMETHAMINE
USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA
ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID
LEVELS
ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA
ADMINISTRATION OF APPROVED PRODUCT FOR TREATMENT OF ALZHEIMER'S DISEASE
TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
METHOD OF TREATING ANDROGEN RESPONSIVE OR MEDICATED CONDITION IN A MAMMAL BY
ADMINISTERING A SAFE & EFFECTIVE AMOUNT OF DUTASTERIDE OR A PHARMACEUTICALLY
ACCEPTABLE SOLVATE THEREOF.. CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY
METHOD OF TREATING AN ANDROGEN RESPONSE OR MEDIATED DISEASE IN A MAMMAL BY
ADMININSTERING AN EFFECTIVE ANDROGEN RESPONSIVE OR MEDICATED DISEASE AMOUNT OF
DUTASTERIDE..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERPLASIA
TREATMENT OF CANCER
TREATMENT OF ASTHMA
A METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING AN EXCLUSIVE
COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
A METHOD TO CONTROL ABUSE OF A SENSITIVE DRUG BY CONTROLLING WITH A COMPUTER
PROCESSOR THE DISTRIBUTION OF THE SENSITIVE DRUG VIA AN EXCLUSIVITY CENTRAL
PHARMACY THAT MAINTAINS A CENTRAL DATABASE
METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION
THE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A
CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME
USE FOR THE TREATMENT OF ASTHMA AND COPD
USE OF EXENATIDE MAY RESULT IN REDUCTION IN BODY WEIGHT
USE FOR THE TREATMENT OF ASTHMA
REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA) IN PATIENTS WITH NEUROLOGIC
CONDITIONS ASSOCIATED WITH PROBLEM DROOLING
PRETREATMENT OF PATIENTS WITH VITAMIN B12 AND FOLIC ACID PRIOR TO PEMETREXED
DISODIUM ADMINISTRATION
TREATMENT OF ACNE
REVLIMID (LENALIDOMIDE) IS INDICATED FOR THE TREATMENT OF PATIENTS WITH
TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
METHOD TO TREAT PULMONARY HYPERTENSION BY ADMINISTERING AMBRISENTAN TO A PATIENT
LUMIGAN IS A PROSTAGLANDIN ANALOG INDICATED FOR THE REDUCTION OF ELEVATED
INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION
WHERE AN INFECTION OR RISK OF INFECTION EXISTS
ACUTE TREATMENT OF MIGRAINE ATTACKS, WITH OR WITHOUT AURA, AND THE TREATMENT OF
CLUSTER HEADACHE EPISODES
RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID
RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER
METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL
DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME
TREATMENT OF AUTOIMMUNE DISEASE
DETECTION OF NON-MUSCLE INVASIVE PAPILLARY CANCER OF THE BLADDER BY PHOTODYNAMIC
CYSTOSCOPY
RELIEF OF MUSCLE SPASM
INHIBITION OF THROMBIN
LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO
USE ORAL CONTRACEPTIVES AS A METHOF OF CONTRACEPTION
ASSESSMENT OF BRONCHIAL HYPERRESPONSIVENESS IN PATIENTS 6 YEARS OF AGE OR OLDER
WHO DO NOT HAVE CLINICALLY APPARENT ASTHMA
TREATMENT OF BREAST CANCER
TREATMENT OF PSEUDOBULBAR AFFECT
MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN
METHOD OF TREATING OCULAR INFLAMMATION
TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER
ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS
APPROPRIATE
METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 55 of 73

PATENT USE
U-1099
U-1100
U-1101
U-1102
U-1103
U-1104
U-1105
U-1106
U-1107
U-1108
U-1109

U-1110
U-1111
U-1112
U-1113
U-1114
U-1115
U-1116
U-1117
U-1118
U-1119
U-1120
U-1121
U-1122
U-1123
U-1124
U-1125
U-1126

U-1127
U-1128

U-1129
U-1130
U-1131
U-1132
U-1133
U-1134
U-1135
U-1136

U-1137
U-1138

TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL

NEUROPATHY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA
REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY
METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A
DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN
TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND
OLDER
TREATING HYPERTRIGLYCERIDEMIAS WITH REDUCTION OF FOOD EFFECT
TREATING HYPERCHOLESTEROLEMIAS WITH REDUCTION OF FOOD EFFECT
TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE
TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL) IN
CONNECTION WITH A SPECIAL PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE
EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)
METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN
A COMPUTER SYSTEM FOR DISTRIBUTION
NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
METHOD OF MR IMAGING OF A MAMMAL
TREATMENT AND PROPHYLAXIS OF INFLUENZA
TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING
NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD
ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
TREATMENT OF BREAST CANCER
USE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING
CHRONIC BRONCHITIS AND EMPHYSEMA
CONTRAST AGENT FOR MAGNETIC RESONANCE IMAGING
TO REDUCE GASTROINTESTINAL SIDE EFFECTS ADMINISTER WITH A MEAL; AS STARTING DOSE
ADMINISTER ONCE DAILY WITH EVENING MEAL
METHOD OF TREATING TRAVELERS' DIARRHEA
TREATMENT OF SECONDARILY INFECTED TRAUMATIC SKIN LESIONS DUE TO S. AUREUS AND S.
PYOGENES
TREATMENT OF ALCOHOL DEPENDENCE
PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
METHOD FOR THE DETECTION OF NEUROENDOCRINE TUMORS
USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
CONTAINING DOCETAXEL
TREATMENT OF PATENT DUCTUS ARTERIOSUS
TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH
PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH
COMPENSATED LIVER DISEASE
TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR A NIGHT WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
TREATMENT OF HYPERTRIGLYDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT
TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A) AND INCREASE OF HDL-C
SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF
HDL-C
TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C
TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING
OR AT NIGHT

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 56 of 73

PATENT USE

U-1139
U-1140
U-1141
U-1142
U-1143

U-1144
U-1145
U-1146
U-1147
U-1148

U-1149
U-1150
U-1151
U-1152
U-1153

U-1154

U-1155
U-1156
U-1157

U-1158

U-1159

U-1160

U-1161
U-1162
U-1163
U-1164
U-1165
U-1166
U-1167
U-1168

U-1169

U-1170
U-1171
U-1172

REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER

DAY IN THE EVENING OR AT NIGHT

REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT

NIGHT

REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT

TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING

OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN

REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER

DAY IN THE EVENING OR A T NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT

SUCH AS ASPIRIN

REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT

NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN

REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH

PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN

REDUCTION IN TG WITH REDUCED FLUSHING BY DOSING ONCE PER DAY IN THE EVENING OR AT

NIGHT

TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING

OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C

REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER

DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTINO OF LDL-C, TC, TG, LP(A), AND

INCREASE OF HDL-C

TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT

NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN

TRETMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT

NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, TG, LP(A), AND INCREASE OF HDL-C

TREATMENT OF HYPERTRIGLYCDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT

NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, LP(A), AND INCREASE OF HDL-C

CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION

IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IS INDICATED FOR THE TREATMENT OF

HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN ANTIRETROVIRAL TREATMENTNAIVE ADULT PATIENTS, AS SET FORTH IN THE LABELING, INCLUDING I&U SECTION

TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL

TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH

SUNITINIB

USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM

LEPROSUM (ENL)

TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA

(HPA)

RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES IN ADULTS AND CHILDREN 2

YEARS OF AGE AND OLDER AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH HIVES

(URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER

RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES AND FOR THE RELIEF OF

SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE

AND OLDER

RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES, SWELLING OF THE NASAL

PASSAGES AND SINUS CONGESTION AND PRESSURE IN ADULTS AND CHILDREN 12 YEARS OF AGE

AND OLDER

RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES AND FOR THE RELIEF OF

SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE

AND OLDER AND 12 YEARS OF AGE AND OLDER

FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL

MEDITERRANEAN FEVER

TREATMENT OF SEBORRHEIC DERMATITIS OF THE SCALP

METHOD OF TREATING THROMBOSIS

METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION

USE FOR THE TREATMENT OF MULTIPLE MYELOMA

A METHOD FOR TREATMENT OF GOUT FLARES DURING PROPHYLAXIS

PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)

THE LONG TERM, ONCE-DAILY MAINTENANCE BROCHODILATOR TREATMENT OF AIRFLOW

OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD),

INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA

MANAGEMENT OF BREAKTHROUGH PAIN IN CANCER PATIENTS 18 YEARS OF AGE AND OLDER WHO

ARE RECEIVING AND TOLERANT TO OPIOID THERAPY FOR THEIR UNDERLYING PERSISTENT

CANCER PAIN

TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

REDUCTION OF THE RATE OF THROMBOTIC EVENTS IN PATIENTS WITH ACUTE CORONARY

SYNDROME

TO REDUCE ELEVATED TOTAL-C, APO B, AND NON-HDL-C IN PATIENTS WIHT PRIMARY

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 57 of 73

PATENT USE

U-1173

U-1174

U-1175
U-1176
U-1177
U-1178
U-1179
U-1180

U-1181
U-1182
U-1183
U-1184
U-1185
U-1186
U-1187
U-1188
U-1189
U-1190
U-1191

U-1192

U-1193

U-1194
U-1195

U-1196

U-1197
U-1198
U-1199
U-1200
U-1201
U-1202
U-1203
U-1204
U-1205
U-1206
U-1207
U-1208
U-1209

HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE IN COMBINATION WITH A STATIN

TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY
HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A
STATIN OR WITH FENOFIBRATE
ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER
FOR INJECTION, 0.9% SODIUM CHLORIDE INJECTION, OR FLOLAN STERIILE DILUENT FOR
INJECTION PRIOR TO ADMINISTRATION
REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION
TREATMENT OR PREVENTION OF STROKE
REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION
RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE
INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING
THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS
A METHOD OF TREATING OR PREVENTING OCULAR PAIN IN A PATIENT
TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
A METHOD FOR ADMINISTERING FOLLICLE STIMULATING HORMONE (FSH) FOR OVARIAN FOLLICLE
OR TESTICULAR STIMULATION IN THE HUMAN
TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC
HYPERPLASIA
TREATMENT OF OPIOID-INDUCED CONSTIPATION
ADMINISTRATION OF AN INHALABLE POWDER COMPRISING TIOTROPIUM VIA DEVICE
TREATMENT OF PATHOLOGICAL STATE BY ANTAGONIZING BRADYKININ RECEPTOR INCLUDING
TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE)
METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
METHOD OF TX TYPE 2 DM IN PTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND
SIMVASTATIN IS APPROPRIATE, IN COMBO WITH AN AGENT ACTING ON AN ATP-DEPENDENT
CHANNEL IN BETA CELLS SUCH AS A SULFYONYLUREA(INCL GLIPIZIDE, GLIMEPIRIIDE &
GLYBURIDE)
METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A
SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
METHOD OF TREATING TYPE 2 DIABETES MELITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA
AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
METHOD FOR TREATING INSOMNIA
PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
KIDNEY DISEASE (CKD) STAGE 5, WHICH MAY RESULT IN RENAL OSTEODYSTROPHY, WHILE
AVOIDING HYPERPHOSPHATEMIA
RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO
DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE
TAKING IBUPROFEN FOR THOSE INDICATIONS
METHOD OF TREATMENT OF CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY
RECTIV IS A NITRATE VASODILATOR INDICATED FOR THE TREATMENT OF MODERATE TO SEVERE
PAIN ASSOCIATED WITH CHRONIC ANAL FISSURE
TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS
AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL
SYNDROME
METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
TREATMENT OF UVEITIS
TREATMENT OF MACULAR EDEMA
DELIVERING AN OCULAR IMPLANT AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION
OF THE APPROVED LABELING OF OZURDEX
INFANT USE AGED 1 MONTH TO LESS THAN ONE YEAR, GERD AND EROSIVE ESOPHAGITIS
TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING
LENGTH, THICKNESS AND DARKNESS
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 58 of 73

PATENT USE

U-1210
U-1211
U-1212
U-1213
U-1214

U-1215
U-1216
U-1217
U-1218
U-1219
U-1220
U-1221
U-1222
U-1223
U-1224
U-1225
U-1226
U-1227
U-1228

U-1229
U-1230
U-1231
U-1232

U-1233
U-1234
U-1235
U-1236
U-1237

U-1238
U-1239
U-1240
U-1241
U-1242
U-1243

U-1244
U-1245
U-1246
U-1247
U-1248

YEARS OF AGE AND OLDER

USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER

CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)

USE OF REVLIMID (LENALIDOMIDE) TO INHIBIT THE SECRETION OF PRO-INFLAMMATORY

CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA

USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA AND

TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)

TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN IMMUNOCOMPETETENT PATIENTS 12 YEARS

OF AGE AND OLDER

METHOD FOR RELIEVING CONSTIPATION IN A HUMAN PATIENT THAT COMPRISES ADMINISTERING

TO THE PATIENT A DOSAGE UNIT COMPRISING (I) 24MCG+/- 10% OF A DRUG SUBSTANCE AND

(II) A PHARMACEUTICALLY SUITABLE EXCIPIENT

USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF TRANSFUSION-DEPENDENT ANEMIA

IN MYELODYSPLASTIC SYNDROMES (MDS)

USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA

METHOD OF INCREASING HAIR GROWTH

METHOD OF STIMULATING HAIR GROWTH

METHOD OF INCREASING THE NUMBER OF HAIRS

TREATMENT OF RENAL CELL CARCINOMA

TO STIMULATE THE IMMUNE SYSTEM TO INDUCE T CELL PROLIFERATION

TO INHIBIT THE PROLIFERATIVE ACTIVITY OF NEOPLASTIC CELLS

METHOD FOR TREATING TYPE 2 DIABETES USING A SUSTAINED-RELEASE COMPOSITION

CONTAINING EXENATIDE

REDUCTIONS IN BODY WEIGHT ARE OBSERVED WITH EXENATIDE

ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING

PARTIAL LARGE OR SMALL BOWEL RESECTION SURGERY WITH PRIMARY ANASTOMOSIS

A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT

METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH

BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE

METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH

BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE ALONE OR IN

COMBINATION WITH INSULIN

TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS

A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT

TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS

USE AS ANTICOAGULANT IN PTS W/ UNSTABLE ANGINA UNDERGOING PTCA; W/ PROVISIONAL USE

OF GLYCOPROTEIN IIB/IIIA INHIBITOR, AS ANTICOAGULANT IN PTS UNDERGOING PCI AND FOR

PTS W/, OR AT RISK OF, HIT/HITTS UNDERGOING PCI.INTENTED FOR USE W/ASPIRIN

TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION, ADMINISTERED WITH

FOOD

FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL

TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA

REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR

HYPERTENSION

USE OF THALOMID (THALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA

COMBO W/ OTHER ANTIRETROVIRALS FOR TX OF HIV-1 IN ANTIRETROVIRAL TX-EXPERIENCED PT

6 YEARS UP, WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1 STRAINS RESISTANT TO

NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR AND OTHER ANTIRETROVIRALS

TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE

MAGNETIC RESONANCE IMAGING OF THE LIVER

TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO

CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION

MANAGEMENT OF MODERATE TO SEVERE PAIN BY ORALLY ADMINISTERING AN INTACT

COMPOSITION AS CLAIMED

PREVENTION OF RESPIRATORY DISTRESS (RDS) IN PREMATURE INFANTS

WITH DRY HANDS, GENTLY REMOVE THE SUPRENZA (PHENTERMINE HYDROCHLORIDE ODT) TABLET

FROM THE BOTTLE. IMMEDIATELY PLACE THE SUPRENZA TABLET ON TOP OF THE TONGUE WHERE

IT WILL DISSOLVE, THEN SWALLOW WITH OR WITHOUT WATER

METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL

PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONLYUREA

METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL

PEPTIDASE-4 INHIBITOR IN COMBINATION WITH PIOGLITAZONE

SINGLE DOSE ADMINISTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL

ANALGESIA

MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS

USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME

KNEE

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 59 of 73

PATENT USE
U-1249
U-1250
U-1251
U-1252
U-1253
U-1254
U-1255
U-1256
U-1257
U-1258
U-1259
U-1260

U-1261
U-1262
U-1263
U-1264
U-1265
U-1266
U-1267
U-1268
U-1269
U-1270
U-1271

U-1272
U-1273
U-1274
U-1275
U-1276
U-1277
U-1278
U-1279
U-1280
U-1281
U-1282
U-1283
U-1284
U-1285
U-1286
U-1287
U-1288
U-1289
U-1290
U-1291

TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A

TERATOGENIC DRUG
TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL
NEUROPATHY OR SPINAL CORD INJURY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA
A METHOD OF CONTROLLING POSTOPERATIVE OCULAR PAIN AND BURNING/STINGING IN A
PATIENT
METHOD FOR CHRONIC WEIGHT MANAGEMENT BY DECREASING FOOD INTAKE
METHOD FOR CHRONIC WEIGHT MANAGEMENT BY INDUCING SATIETY
METHOD FOR CHRONIC WIEGHT MANAGEMENT BY CONTROLLING WEIGHT GAIN
METHOD FOR CHRONIC WEIGHT MANAGEMENT BY TREATING OBESITY
TREATMENT OF SEBORRHEIC DERMATITIS
TREATMENT OF OPHTHALMIC DISORDERS
VISUALIZATION DURING VITRECTOMY PROCEDURES
PROPHYLAXIS OF HIV-1 INFECTION
TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR
THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED
DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
REDUCTION OF THE RISK OF HOSPITALIZATION FOR ATRIAL FIBRILLATION
USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT
NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS
TREATMENT OF A RESPIRATORY DISEASE
PATENTED METHOD OF USING REPAGLINIDE IN COMBINATION WITH METFORMIN AS INDICATED
FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
TREATMENT OF RHEUMATOID ARTHRITIS BY DELAYED RELEASE FORMULATION OF 1MG OR 2MG OF
PREDNISONE
TREATMENT OF PULMONARY, GASTROINTESTINAL AND/OR RHEUMATOLOGICAL DISEASES OR
CONDITIONS BY USE OF DELAYED RELEASE FORMULATIONS OF 1MG OR 2MG PREDNISONE
TREATMENT OF RHEUMATOLOGIC, ALLERGIC, PULMONARY, GASTROINTESTINAL, DERMATOLOGIC
DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 5MG PREDNISONE TABLET
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE(PH-) ACUTE
LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS
PROGRESSED FOLLOWING TWO OR MOR ANTI-LEUKEMIA THERAPIES
TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSON'S DISEASE BY APPLICATION OF CLAIMED
TRANSDERMAL SYSTEM
TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY
SYSTEM
TREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER
CONDITIONS
TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE
AND OLDER
MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
METHOD OF INCREASING EYELASH GROWTH INCLUDING LENGTH, THICKNESS, DARKNESS AND/OR
NUMBER OF EYELASHES BY ADMINISTERING BIMATOPROST TO AN EYELID MARGIN
METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKNIETIC
ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO
HAVE PREVIOUSLY RECEIVED DOCETAXEL
PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING
A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
A METHOD OF TREATING A NEOPLASM
TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT
WITH INHALED NITRIC OXIDE
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET
MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
TREATMENT OF LUNG CANCER
TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL) IN PATIENTS WHOSE APL IS
CHARACTERIZED BY THE PRESENCE OF THE (15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE
EXPRESSION

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 60 of 73

PATENT USE
U-1292
U-1293
U-1294
U-1295
U-1296
U-1297
U-1298
U-1299
U-1300
U-1301
U-1302
U-1303
U-1304
U-1305

U-1306
U-1307

U-1308
U-1309
U-1310
U-1311
U-1312
U-1313
U-1314
U-1315
U-1316

U-1317
U-1318

U-1319
U-1320
U-1321
U-1322
U-1323
U-1324
U-1325
U-1326
U-1327

U-1328
U-1329
U-1330

TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1, 2, OR 5 MG

PREDNISONE TABLET
A METHOD OF LOWERING INTRAOCULAR PRESSURE IN A PATIENT WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
METHOD OF TREATING GLAUCOMA IN A PATIENT
A METHOD OF TREATING A PATIENT WITH GLAUCOMA OR OCULAR HYPERTENSION
USE OF PEMETREXED WITH PRIOR AND/OR REPEATED VITAMIN B12 AND FOLIC ACID
ADMINISTRATION
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION BY INHIBITING ENDOTHELIN RECEPTORS
ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES
TREATMENT OF PATIENTS WITH LEUKEMIA INCLUDING CHRONIC MYELOID/MYELOGENOUS LEUKEMIA
(CML)
TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT
CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)
TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
TREATMENT OF PULMONARY EMBOLISM (PE)
REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY
EMBOLISM
USE OF ONCE-A-DAY AMOXICILLIN PRODUCT TO TREAT TONSILLITIS AND/OR PHARYNGITIS
SECONDARY TO STREPTOCOCCUS PYOGENES
TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN
PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR
(PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE
INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1
INFECTION IN TREATMENT-NAIVE ADULT PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO
100,000 AT THE START OF THERAPY
MULTIPLE MYELOMA
BONE METASTASES
FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
METHOD OF TREATING CYSTIC FIBROSIS
USE FOR THE TREATMENT OF HYPERGLYCEMIA
AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE
2 DIABETES MELLITUS
USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER
THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND
GLAUCOMA
A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEPWISE INCREASING DOSES
TREATMENT OF HYPERCHOLESTEROLEMIA, HYPERLIPIDEMIA AND HYPERLIPOPROTEINEMIA IN
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
TREATMENT OF HYPERCHOLESTEROLEMIA BY DECREASING THE AMOUNT OR ACTIVITY OF
MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN IN PATIENTS WITH HOMOZYGOUS FAMILIAL
HYPERCHOLESTEROLEMIA
SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON
PARENTERAL SUPPORT
TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
METHOD OF REDUCING OCULAR HYPERTENSION
REDUCING THE RISK OF STROKE
MANAGEMENT OF CYSTIC FIBROSIS PATIENTS
INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE
COLITIS
METHOD OF INDUCING CONTRACEPTION IN A FEMALE OF REPRODUCTIVE AGE WHO HAS NOT YET
REACHED PREMENOPAUSE
METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING
IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF, USING A
FLOWABLE HYDROGEL FORMULATION
METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING
IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER
METHODS OF TREATING LIPID METABOLISM AND GLYCOMETABOLISM DISORDERS COMPRISING
ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION
WITH AN INSULIN SECRETION ENHANCER

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 61 of 73

PATENT USE
U-1331

U-1332

U-1333
U-1334
U-1335

U-1336
U-1337
U-1338
U-1339
U-1340

U-1341

U-1342

U-1343

U-1344

U-1345

U-1346

U-1347
U-1348
U-1349
U-1350
U-1351
U-1352
U-1353

U-1354
U-1355

U-1356

U-1357

U-1358
U-1359
U-1360
U-1361
U-1362

METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC

PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
METHODS OF LOWERING ELEVATED POST PRANDIAL BLOOD GLUCOSE LEVELS COMPRISING
ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR
METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING
ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC
AGENTS SUCH AS METFORMIN
METHODS OF TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE
INHIBITOR AND METFORMIN
METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
METHODS OF TREATING LIPID METABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS
METFORMIN
METHODS OF TREATING GLYCOMETABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS
METFORMIN
METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN PREPARATION
USE IN RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH A DOSAGE UNIT
COMPRISING 24MICROG+/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE
EXCIPIENT
USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM
GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF
THEOPHYLLINE
TREATMENT OF A SKIN DISORDER
TREATMENT OF OSTEOARTHRITIS
TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS
TREATMENT OF ANKYLOSING SPONDYLITIS
TREATMENT OF ACUTE PAIN
TREATMENT OF PRIMARY DYSMENORRHEA
ADJUNCTIVE THERAPY TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LOW DENSITY
LIPOPROTEIN-CHOLESTEROL, APOLIPOPROTEIN B, TOTAL CHOLESTEROL, AND NON-HIGH DENSITY
LIPOPROTEIN CHOLESTEROL IN PTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
INHIBITION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN
HYPERSTIMULATION WITH FSH
MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT
PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A
RESPIRATORY DISEASE IN A CHILD
TREATMENT OF NASAL SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS
AND CHILDREN 6 YEARS OF AGE AND OLDER. TREATMENT OF NASAL SYMPTOMS ASSOCIATED W
PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER
TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR
TREATING A RESPIRATORY DISEASE IN A CHILD
TREATMENT OF BACTERIAL INFECTIONS IN THE NASAL PASSAGE OF ADULT PATIENTS AND
HEALTH CARE WORKERS WITH METHICILLIN RESISTANT S. AUREUS
USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES,
INCLUDING TUMOR NECROSIS FACTOR ALPHA
USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER
CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 62 of 73

PATENT USE

U-1363
U-1364
U-1365
U-1366
U-1367
U-1368
U-1369
U-1370
U-1371
U-1372
U-1373
U-1374
U-1375
U-1376
U-1377
U-1378
U-1379
U-1380

U-1381
U-1382
U-1383
U-1384
U-1385
U-1386
U-1387

U-1388

U-1389

U-1390
U-1391
U-1392
U-1393
U-1394

U-1395

U-1396

U-1397
U-1398

PREDNISONE TABLET
A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING/STINGING FOLLOWING
CORNEAL SURGERY
MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO
ANOVULATORY INFERTILE WOMEN
METHOD OF ADMINISTERING FSH FOR THE TREATMENT OF INFERTILITY THROUGH INDUCTION OF
OVULATION AND PREGNANCY IN ANOVULATORY INFERTILE WOMEN
TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC),
AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING
OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH ELEVATED INTRAOCULAR PRESSURE
OR GLAUCOMA
ADMINISTRATION WITHOUT FOOD FOR TREATMENT OF HIV-1 INFECTION
METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
ADASUVE IS A TYPICAL ANTIPSYCHOTIC INDICATED FOR THE ACUTE TREATMENT OF AGITATION
ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I DISORDER IN ADULTS
TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS
AERUGINOSA
TREATMENT OF A NITROGEN METABOLISM DISORDER
IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE
ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE
ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS WHEREIN THE PATIENT HAS
CARDIOVASCULAR DISEASE
USE OF PRASUGREL AND ASPIRIN IN PATIENTS REQUIRING THE REDUCTION OF THROMBOTIC
CARDIOVASCULAR EVENTS
TREATMETN OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO
CONSERVATIVE MANAGEMENT
DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE
DISORDER
METHOD OF TREATING MULTIPLE SCLEROSIS
METHOD OF TREATING AN AUTOIMMUNE DISEASE SELECTED FROM AUTOIMMUNE POLYARTHRITIS
AND MULTIPLE SCLEROSIS BUT NOT TREATING PSORIATIC ARTHRITIS
A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH A HISTORY OF PAROXYSMAL OR
PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY
ADMINISTRATION TWICE A DAILY WITH MORNING AND EVENING MEALS
TREATMENT OF PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE
HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH
MORNING AND EVENING MEALS
ELLA IS AN PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR
THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR
SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD
A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN
NEED THEREOF
METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION
METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH OPIOIDINDUCED CONSTIPATION
METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED
CONSTIPATION
METHOD FOR RELIEVING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION
THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING(I)24MICROG+/10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
USE IN RELIEVING OR PREVENTING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED
CONSTIPATION WITH A DOSAGE UNIT COMPRISING 24MICROG +/- 10% OF A DRUG SUBSTANCE
AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN
COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR
ANASTROZOLE
USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY
METHOD OF TREATING CHRONIC HEPATITIS C

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 63 of 73

PATENT USE
U-1399
U-1400
U-1401

U-1402
U-1403

U-1404
U-1405
U-1406
U-1407
U-1408
U-1409
U-1410
U-1411
U-1412
U-1413
U-1414
U-1415

U-1416
U-1417
U-1418
U-1419
U-1420
U-1421
U-1422
U-1423

U-1424

U-1425
U-1426
U-1427

U-1428
U-1429
U-1430
U-1431

U-1432
U-1433
U-1434
U-1435
U-1436

MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO

DIVIDED DOSES
FOR THE TREATMENT OF PRIMARY HYPERLIPIDEMIA, MIXED HYPERLIPIDEMIA OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA
INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION
IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE
EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
FIRST-LINE TREATMENT OF METASTATIC NON SMAL-CELL LUNG CANCER (NSCLC) WITH EGFR
EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDAAPPROVED TEST
METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY
OPENING CIC CHANNELS
THERAPEUTIC TREATMENT OF BONE METASTASES
TREATMENT OF MELANOMA
TREATMENT OF NEWLY DIAGNOSED PHILADELPIA CHROMOSOME POSITIVE CHRONIC MYELOID
LEUKEMIA (PH + CML)
TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION
TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES
THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT
OF OPIOID DEPENDENCE
TREATMENT OF ATOPIC DERMATITIS
ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH FLOLAN STERILE
DILUENT FOR INJECTION PRIOR TO INFUSION
USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MANTLE CELL LYMPHOMA (MCL)
TREATMING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH
METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS
1 OR 2
USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APOLIPOPROTEIN B, OR TOTAL TRIGLYCERIDES
USE FOR TREATMENT OF HELICOBACTER INFECTIONS
TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAFV600E
MUTATION AS DETECTED BY AN FDA APPROVED TEST
TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
METHOD OF ONCE A DAY ADMINISTRATION
SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
METHOD OF TREATING PATIENTS NEEDING AN IRON SUPPLEMENT
AMYVID IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET)
IMAGING OF THE BRAIN TO ESTIMATE BETA-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT
PATIENTS WITH COGNITIVE IMPAIRMENT
LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH
COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSOTO REDUCE EXACERBATIONS
OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
AND NALOXONE
USE FOR TREATMENT OF DIAPER DERMATITIS COMPLICATED BY CANDIDIASIS
ALKYLATING DRUG INDICATED FOR THE TOPICAL TREATMENT OF STAGE IA AND IB MYCOSIS
FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN
DIRECTED THERAPY
TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
TREATMENT OF PATIENTS WITH BREAST CANCER WHOSE TUMORS OVEREXPRESS THE HER2
RECEPTOR
TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
METHOD OF TREATING HYPERGLYCEMIA TO IMPROVE GLYCEMIC CONTROL IN A PATIENT BY ORAL
ADMIN OF ONCE A DAY OSMOTIC DOSAGE FORM OF GLIPIZIDE WITH POLYETHYLENE OXIDE,
HYDROXYPROPYLMETHYLCELLULOSE, CELLULOSE ACETATE, AND SODIUM CHLORIDE
METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF
ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX
IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE
OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
TREATMENT OF PANCREATIC CANCER
COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AN DADMINISTRATION OF AN ORAL
NSAID.
USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM
SUNSCREEN AND INSECT REPELLANT

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 64 of 73

PATENT USE
U-1437
U-1438

U-1439
U-1440
U-1441
U-1442
U-1443
U-1444

U-1445

U-1446
U-1447
U-1448
U-1449
U-1450
U-1451

U-1452
U-1453
U-1454
U-1455
U-1456
U-1457
U-1458
U-1459
U-1460
U-1461
U-1462

U-1463

U-1464
U-1465
U-1466
U-1467
U-1468
U-1469
U-1470
U-1471

U-1472
U-1473
U-1474

U-1475
U-1476

ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT

FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
ZINGO INTRADERMAL INJECTION SYSTEM IS A DRUG DELIVERY SYSTEM THAT IS CAPABLE OF
DELIVERING FINE DRY POWDERED LIDOCAINE HYDROCHLORIDE MONOHYDRATE FOR LOCAL
ANESTHETIC ACTION
METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
A METHOD OF TREATING OR REDUCING OCULAR PAIN AND BURNING/STINGING
SUBCUTANEOUS INJECTION OF METHOTREXATE
ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING
SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY
0.15MCG/KG/MIN) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH
ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS
METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A
PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE
POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN
COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES
TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
TREATING SEVERE HYPERTRIGLYCERIDEMIA
METHOD OF ALLEVIATING A SKIN CONDITION
TREATMENT OF ALLERGIC RHINITIS SYMPTOMS
APPROVED INDICATIONS: APTIOM (ESLICARBAZEPINE ACETATE) IS INDICATED AS ADJUNCTIVE
TREATMENT OF PARTIAL-ONSET SEIZURES AND APPROVED IN PATIENTS WITH EPILEPSY.
PATENT CLAIMS: IN A METHOD OF TREATING A SUBJECT AFFLICTED WITH EPILEPSY
METHOD FOR CHRONIC WEIGHT MANAGEMENT
A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF
NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
TREATMENT OF PERIANAL WARTS
TREATMENT OF MANTLE CELL LYMPHOMA
A METHOD OF PURGING A NITRIC OXIDE DELIVERY SYSTEM
A METHOD OF REDUCING INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
TREATMENT OF CARCINOMA OF THE THYROID
TREATMENT OF HERPES LABIALIS
A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE
A METHOD OF USING A SCLEROSING AGENT FOR THE TREATMENT OF INCOMPETENT GREAT
SAPHENOUS VEINS, ACCESSORY SAPHENOUS VEINS AND VISIBLE VARICOSITIES OF THE GREAT
SAPHENOUS (GSV) SYSTEM ABOVE AND BELOW THE KNEE
A METHOD OF INTRAVENOUS INJECTION USING ULTRASOUND GUIDANCE, ADMINISTERED VIA A
SINGLE CANNULA INTO THE LUMEN OF THE TARGET INCOMPETENT TRUNK VEINS OR BY DIRECT
INJECTION INTO VARICOSITIES
TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER
CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE
RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES ADULTS AND CHILDREN 6
YEARS OF AGE AND OLDER
METHOD OF TREATING HEPATITIS C
CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS
USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
FOR THE TREATMENT OF HEPATITIS C
A METHOD FOR TREATING CARDIOVASCULAR DISEASE COMPRISING ADMINISTERING A
RECONSTITUTED LYOPHILIZED PHARMACEUTICAL COMPOSITION COMPRISING EPOPROSTENOL,
ARGININE AND SODIUM HYDROXIDE.
INTENSIVE CARE UNIT SEDATION, INCLUDING SEDATION OF NON-INTUBATED PATIENTS PRIOR
TO AND/OR DURING SURGICAL AND OTHER PROCEDURES
MANAGEMENT OF RISK OF DRONEDARONE/BETA-BLOCKER INTERACTION IN PATIENTS IN SINUS
RYTHM WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF
A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH
ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO
THE SKIN OF THE PATIENT
USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO
GROUP 1).
INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW
OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD),

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 65 of 73

PATENT USE

U-1477
U-1478
U-1479
U-1480
U-1481
U-1482
U-1483
U-1484

U-1485

U-1486
U-1487
U-1488
U-1489
U-1490
U-1491
U-1492
U-1493
U-1494
U-1495
U-1496
U-1497

U-1498
U-1499
U-1500

U-1501
U-1502
U-1503
U-1504
U-1505
U-1506

U-1507
U-1508

U-1509
U-1510
U-1511
U-1512
U-1513
U-1514
U-1515
U-1516
U-1517
U-1518
U-1519

INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.

USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION
ON THE SAME KNEE
METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE
HYPERTRIGLYCERIDEMIA
INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY
EYE).
TREATMENT OF ADVANCED RENAL CELL CARCINOMA
REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD
SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION
HEALING TIME IN ADULTS AND CHILDREN (6 YEARS OF AGE AND OLDER)
TREATING A SUBJECT UNDERGOING ABDOMINAL SURGERY BY ADMINISTERING ALVIMOPAN TO
ACCELERATE THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING
SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER
METHOD OF INCREASING EYELASH GROWTH
USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
FOR USE IN PATIENTS HAVING SYMPTOMATIC OR PROGRESSIVE MEDULLARY THYROID CANCER,
WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC DISEASE
TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
METHOD FOR PREVENTING ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING
BUPRENORPHINE AND NALOXONE
RISK REDUCTION OF REBLEEDING IN PTS FOLLOWING THERAPEUTIC ENDOSCOPY FOR ACUTE
BLEEDING GASTRIC OR DUODENAL ULCERS IN ADULTS.
METHOD TO TREAT HEMANGIOMA.
NEURACEQ IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET)
IMAGING OF THE BRAIN TO ESTIMATE P-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT
PATIENTS WITH COGNITIVE IMPAIRMENT
METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A
DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL
OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
PROPHYLAXIS OF PULMONARY EMBOLISM
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH METFORMIN
USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR (GIST), INCLUDING BUT
NOT LIMITED TO PATIENTS PREVIOUSLY TREATED WITH IMATINIB AND PATIENTS WITH GIST
HAVING RESISTANCE TO A KIT TYROSINE KINASE INHIBITOR
TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM
OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS
CLAIMED
TREATMENT OF FREQUENT HEARTBURN BY ADMINISTERING A GASTRIC ACID REDUCER
MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM
OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
TREATMENT OF HYPERTRIGLYCERIDEMIA
REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS
TREATMENT OF HIV-1 INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL
ADMINISTRATION OF FENTANYL
METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS.
METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.
MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING
POSTOPERATIVE OCULAR PAIN
METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT WITH

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 66 of 73

PATENT USE

U-1520
U-1521
U-1522

U-1523
U-1524
U-1525
U-1526
U-1527
U-1528
U-1529
U-1530
U-1531
U-1532
U-1533
U-1534
U-1535
U-1536
U-1537
U-1538
U-1539
U-1540

U-1541

U-1542
U-1543
U-1544
U-1545
U-1546

U-1547
U-1548

U-1549
U-1550
U-1551
U-1552
U-1553
U-1554
U-1555

U-1556
U-1557

IRRITABLE BOWEL SYNDROME

METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT

MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL

(HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN,

PIOGLITAZONE, OR ROSIGLITAZONE

METHOD OF INDUCING TOPICAL ANESTHESIA IN THE EYE

REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY

THE TREATMENT OF PATIENTS WITH TRAVELERS' DIARRHEA (TD) OR THE REDUCTION IN RISK

OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY

INCONTINENCE, URGENCY, AND URINARY FREQUENCY

A METHOD OF LOWERING INTRAOCULAR PRESSURE

ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION

METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE

METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY

PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.

PULMONARY ADMINISTRATION OF PARTICLES COMPRISING A DIKETOPIPERAZINE AND INSULIN.

ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH A

DIKETOPIPERAZINE.

ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES

OF A DIKETOPIPERAZINE.

ADMINISTRATION OF A COMPOSITION COMPRISING A DIKETOPIPERAZINE AND INSULIN.

TREATMENT OF A PATIENT HAVING DIABETES MELLITUS WITH A PRANDIAL RAPID ACTING

INSULIN.

ADMINISTRATION OF FDKP MICROPARTICLES COMPRISING INSULIN.

PULMONARY ADMINISTRATION OF AN INSULIN COMPOSITION COMPRISING FDKP AT THE

BEGINNING OF A MEAL TO A PATIENT ALSO BEING TREATED WITH A LONG-ACTING INSULIN.

BUTRANS IS A PARTIAL OPIOID AGONIST PRODUCT INDICATED FOR THE MANAGEMENT OF PAIN

SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT FOR

WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.

TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL

GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE

CURATIVELY RESECTED.

FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NONHODGKINS LYMPHOMA

TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR

CLAIM 23

TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA

(PTCL).

A METHOD OF TRANSDERMALLY DELIVERING TESTOSTERONE

FOR USE IN THE TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE

SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS

AT HIGH RISK.

TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC BRONCHITIS OR

EMPHYSEMA

FOR THE LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN

PATIENTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE

EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS

FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA

METHOD OF TREATING METASTATIC PAPILLARY RENAL CELL CARCINOMA WITH TEMSIROLIMUS.

METHOD OF TREATING PAPILLARY RENAL CELL CARCINOMA WITH TEMSIROLIMUS, IN THE

ABSENCE OF INTERFERON ALPHA.

FOR HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE)

TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN

FOR THE TREATMENT OF HEARTBURN ASSOCIATED WITH SYMPTOMATIC NON-EROSIVE

GASTROESOPHAGEAL DISEASE (GERD)

MANAGEMENT OF MODERATE TO SEVERE PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THECLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE

INADEQUATE.

MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM

OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.

A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY

ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF

TESTOSTERONE GEL FORMULATION.

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 67 of 73

PATENT USE
U-1558
U-1559
U-1560
U-1561
U-1562
U-1563
U-1564
U-1565

U-1566
U-1567
U-1568

U-1569
U-1570
U-1571
U-1572
U-1573
U-1574
U-1575
U-1576
U-1577
U-1578
U-1579
U-1580
U-1581
U-1582
U-1583
U-1584
U-1585
U-1586
U-1587
U-1588
U-1589
U-1590
U-1591
U-1592
U-1593
U-1594
U-1595
U-1596

U-1597
U-1598
U-1599

FOR THE TREATMENT OF PATIENTS WITH RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA
OR [RELAPSED] SMALL LYMPHOCYTIC LYMPHOMA
INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC
THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER
A METHOD OF DISRUPTING LEUKOCYTE FUNCTION, INCLUDING AS AN INHIBITOR OF PI3KDELTA
KINASE
USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
TREATMENT OF PATIENTS WITH HEPATIC ENCEPHALOPATHY (HE)
A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A
SUBJECT.
A METHOD OF TREATING GAUCHER'S DISEASE
METHOD OF TREATING, AS INTITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE
THERAPY, PARITAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE
METHOD OF TREATING, AS MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES
IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER
METHOD OF TREATING, AS INTITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE
THERAPY, PARITAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
METHOD OF TREATING, AS MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES
IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL ADMINISTRATION IS
TEMPORARILY NOT FEASIBLE
TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE
TREATMENT OF GAUCHER DISEASE TYPE 1
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION.
USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1
AND/OR JAK2.
A METHOD OF CATALYZING THE HYDROLYSIS OF GLUCOCEREBROSIDE TO GLUCOSE AND CERAMIDE.
PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO
IMMUNOSUPPRESSIVE THERAPY
TREATMENT OF LEUKEMIA
CONTROL OF SERUM PHOSPHOROUS LEVELS
TREATMENT OF ACUTE OTITIS MEDIA
USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER
USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER WHO HAD RECEIVED PRIOR DOCETAXEL CHEMOTHERAPY
IN COMBINATION WITH DABRAFENIB FOR THE TREATMENT OF UNRESECTABLE OR METASTATIC
MELANOMA.
TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA
FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT
MANAGEMENT FOR AFFECTING WEIGHT LOSS
USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
FOR EFFECT ON BLOOD GLUCOSE PARAMETERS IN PATIENTS WITH INSULIN RESISTANCE
SINGLE-DOSE INFILTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL ANALGESIA.
THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
(CRPC).
METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM
HYPERPHENYLALANINEMIA
KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH
HYPERPHENYLALANINEMIA
TREATMENT OF ASTHMA IN PATIENTS AGED 12 YEARS AND OLDER
TO REDUCE SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC
BRONCHITIS AND EMPHYSEMA, AND REDUCTION OF EXACERBATIONS IN COPD PATIENTS.
DILATION OF THE PUPIL
USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY
IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES
PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
TREATMENT OF DIABETIC MACULAR EDEMA
METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE
MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN
ADNUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI INFLAMMATORY,
ANALGESIC, AND ANTIPYRETIC ACTIVITY

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 68 of 73

PATENT USE
U-1600
U-1601
U-1602
U-1603
U-1604
U-1605
U-1606

U-1607
U-1608
U-1609
U-1610
U-1611
U-1612
U-1613
U-1614
U-1615
U-1616
U-1617
U-1618

U-1619
U-1620

U-1621
U-1622
U-1623
U-1624
U-1625
U-1626
U-1627
U-1628
U-1629
U-1630
U-1631
U-1632
U-1633
U-1634
U-1635
U-1636
U-1637
U-1638
U-1639
U-1640

DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC

PULMONARY FIBROSIS
DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG
INHIBITOR OF CYP1A2
METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING
SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER
METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT
USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME
INVOLVED IN PIRFENIDONE METABOLISM
METHOD OF ADMINISTERING A DOSAGE FORM THAT INCLUDES A GRANULATE FORMULATION OF
PIRFENIDONE TO TREAT A FIBROTIC CONDITION
DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION
CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN
TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELVATED LIVER ENZYMES IN USE OF
PIRFENIDONE
METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING
SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER
METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING
OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER
DOSAGE MODIFICATION IN TREATMENT WITH PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH
CIPROFLOXACIN
USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A
CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
METHOD OF TREATING MEDULLARY THYROID CANCER
A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE
COMPRISING ADMINISTERING A LIQUID COMPOSITION FONNULATED INSIDE A SOFT GEL
CAPSULE, AS CLAIMED, TO THE PATIENT
TREATMENT OF IMMUNE (IDIOPATIC) THROMBOCYTOPENIA (ITP)
METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF
ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, WITH A SUBSTANTIALLY NONIMMUNOGENIC CARBOHYDRATE COMPONENT, IN ABOUT 15 MINUTES OR LESS.
PULMONARY ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN BOUND TO A COMPLEXING
AGENT.
FOR THE TREATMENT OF POLYCYTHEMIA VERA
USE OF EXENATIDE MAY RESULT IN REDUCTION IN APPETITE.
TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA, ADVANCED RENAL CELL CARCINOMA,
OR DIFFERENTIATED THYROID CARCINOMA.
METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY
REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6
A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING
TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN ADULTS
METHOD OF TREATING DISORDERS WITH AN ETIOLOGY COMPRISING OR ASSOCIATED WITH EXCESS
GH-SECRETION
METHOD OF TREATING ACROMEGALY
TREATMENT IN COMBINATION WITH A CORTICOID SUCH AS PREDNISONE OF PROSTATE CANCER
PREVIOUSLY TREATED IWTH DOCETAXEL
TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF
SCHIZOPHRENIA
USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE
EPISODES OF SCHIZOPHRENIA
TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
USE OF RITONAVIR AS A POTENT CYP3A INHIBITOR TO INCREASE PLASMA DRUG CONCENTRATION
OF PARITAPREVIR AND OVERALL DRUG EXPOSURE FOR TREATMENT OF HCV INFECTION
USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND
DASABUVIR WITH RIBAVIRIN.
TREATMENT OF HCV INFECTION USING PARITAPREVIR
USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT
MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 69 of 73

PATENT USE

U-1641
U-1642

U-1643
U-1644
U-1645
U-1646
U-1647
U-1648

U-1649
U-1650
U-1651
U-1652
U-1653
U-1654
U-1655

U-1656
U-1657

U-1658

U-1659
U-1660
U-1661
U-1662
U-1663
U-1664
U-1665
U-1666
U-1667
U-1668
U-1669
U-1670
U-1671
U-1672
U-1673
U-1674
U-1675
U-1676
U-1677
U-1678
U-1679
U-1680
U-1681

COMPOSITION AS CLAIMED
MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE
DEMENTIA OF THE ALZHEIMER'S TYPE
METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL
IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING
LINAGLIPTIN
TREATING CUSHING'S SYNDROME
TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTININ CHLORIDE GEL TO SKIN
TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM
THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW
CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR
MANGANESE INTOXICATION
TREATMENT OF PATIENTS WITH PARKINSONS DISEASE, POST-ENCEPHALITIC PARKINSONISM,
AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE
INTOXICATION
TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH EMPAGLIFLOZIN
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
A METHOD TO ACCELERATE THE TIME TO GASTROINTESTINAL RECOVERY BY ADMINISTERING
ABOUT 12 MG OF ALVIMOPAN TO THE PATIENT FROM ABOUT 30 TO 60 MINUTES PRIOR TO
SURGERY
METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
METHOD FOR PROVIDING POST COITAL CONTRACEPTION TO A WOMAN BY ADMINISTERING ABOUT
30 MG OF ULIPRISTAL ACETATE WITHIN ABOUT 120 HOURS AFTER INTERCOURSE, WHEREIN THE
WOMAN IS OVERWEIGHT HAVING A BMI OF 25 TO 29.99
TREATMENT OF ER-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER IN COMBINATION WITH
LETROZOLE AS INITIAL ENDOCRINE-BASED THERAPY FOR METASTATIC DISEASE IN
POSTMENOPAUSAL WOMEN
MANAGEMENT OF PAIN
TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED
SUBSTITUTIONS
RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE
ASPIRIN
A METHOD OF TREATING OCULAR PAIN
TREATMENT OF HIV-1 INFECTION
TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL
METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING THE
COMPOSITION OF CLAIM 1
PALLIATIVE TREATMENT OF PROSTATE CANCER
TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL ALLERGIC RHINITIS
METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE
NATROBA TOPICAL SUSPENSION IS A PEDICULICIDE INDICATED FOR THE TOPICAL TREATMENT
OF HEAD LICE INFESTATION IN PATIENTS SIX (6) MONTHS OF AGE AND OLDER.
TREATMENT OF OCULAR ITCHING ASSOCIATED WITH CONJUNCTIVITIS
TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION
TREATMENT OF COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS
DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY
OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
METHODS FOR TREATING BACTERIAL INFECTIONS
TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF)
FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
TREATMENT OF ACUTE OTITIS EXTERNA
TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
TREATMENT OF PATIENTS WITH PROGESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN
(PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 70 of 73

PATENT USE
U-1682
U-1683
U-1684
U-1685
U-1686
U-1687
U-1688
U-1689
U-1690
U-1691
U-1692
U-1693
U-1694
U-1695
U-1696
U-1697
U-1698
U-1699
U-1700
U-1701
U-1702
U-1703
U-1704
U-1705
U-1706

U-1707
U-1708
U-1709
U-1710
U-1711
U-1712
U-1713
U-1714
U-1715

U-1716

U-1717
U-1718
U-1719
U-1720
U-1721
U-1722

TREATMENT OF BACTERIAL VAGINOSIS

TREATMENT FRO CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED
BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
A METHOD TO REDUCE WITHDRAWAL SYMPTOMS, INCLUDING NICOTINE CRAVING, ASSOCIATED
WITH SMOKING CESSATION
TREATMENT OF HCV INFECTION USING OMBITASVIR
METHOD FOR CHRONIC WEIGHT MANAGEMENT BY TREATING OBESITY IN AN INDIVIDUAL WHO DOES
NOT HAVE SEVERE RENAL IMPAIRMENT OR ESRD
METHOD FOR CHRONIC WEIGHT MANAGEMENT BY INDUCING SATIETY IN AN INDIVIDUAL WHO DOES
NOT HAVE SEVERE RENAL IMPAIRMENT OR ESRD
METHOD FOR REDUCTION OF SUBMENTAL FAT
INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS
AND OLDER
METHOD FOR CHRONIC WEIGHT MANAGEMENT BY DECREASING FOOD INTAKE IN AN INDIVIDUAL
WHO DOES NOT HAVE SEVERE RENAL IMPAIRMENT OR ESRD
METHOD OF TREATING ADHD IN CHILDREN 6 YEARS OF AGE AND OLDER AND ADOLESCENTS
A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF
IVABRADINE HYDROCHLORIDE
METHOD FOR TREATING THYROID CARCINOMA INCLUDING DIFFERENTIATED THYROID CANCER
TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA
PULMONARY ADMINISTRATION OF A COMPISITION COMPRISING INSULIN BOUND TO A
DIKETOPIPERAZINE.
PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC
LEUKEMIA
A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE
DOMAIN
TREATMENT OF COPD
TREATMENT OF RESPIRATORY COMPLAINTS
USE FOR TREATMENT IN PATIENTS WITH DIABETES
USE FOR TREATMENT IN PATIENTS WITH HYPERGLYCEMIA
TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRSTPHASE INSULIN SECRETAGOGUE WHEREIN THE COMBINED THERAPEUTIC EFFECT IS GREATER THAN
THE ADDITIVE EFFECT OF ADMINISTERING EACH AGENT ALONE
TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS
THEREOF.
TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.
TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI
(ELUXADOLINE).
TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN
COMBINATION WITH FLUVOXAMINE
FOR THE TREATMENT OF PATIENTS WITH CLL, FL OR SLL
MEKENIST IN COMBINATION WITH DABRAFENIB FOR THE TREATMENT OF PATIENTS WITH
UNRESECTABLE OR METASTATIC MELANOMA
TAFINLAR IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH
UNRESECTABLE OR METASTATIC MELANOMA
TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER
WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY
INTERVENTIONTO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED
WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR
TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A
COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY
ADMINISTERED EXTENDED RELEASE TABLETS
METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL
MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN
THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE.
ACUTE TREATMENT OF MIGRAINE
METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA
LEVEL OF LEVODOPA
USE OF RUXOLITINIB (JAKAFI) FOR BLOCKING SIGNAL TRANSDUCTION OF JANUS ASSOCIATED
KINASES (JAKS) JAK1 AND/OR JAK2
TREATMENT OF BASAL CELL CARCINOMA

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 71 of 73

PATENT USE

U-1723
U-1724
U-1725
U-1726

U-1727
U-1728

U-1729
U-1730
U-1731
U-1732
U-1733
U-1734
U-1735
U-1736
U-1737
U-1738
U-1739

U-1740

U-1741
U-1742
U-1743
U-1744
U-1745
U-1746
U-1747
U-1748
U-1749
U-1750
U-1751

U-1752
U-1753
U-1754
U-1755

U-1756
U-1757
U-1758
U-1759
U-1760
U-1761
U-1762

TREATMENT OF HEART FAILURE

METHOD OF INHIBITING HEPATITIS C VIRUS

METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL

COMPOUND HAVING ANTI-HCV ACTIVITY

REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH CORONARY HEART DISEASE AND A

HISTORY OF PAROXYSMAL OR PERSISTENT AF AND WITH ONE OR MORE RISK FACTORS BY

ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS

TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH STABLE NYHA CLASS III HEART

FAILURE AND A HISTORY OF PAROXYSMAL OR PERSISTENT AF AND WITH ONE OR MORE RISK

FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS

REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT)

REDUCE THE RISK OF RECURRENT PULMONARY EMBOLISM

TEMPORARY RELIEF OF MINOR ACHES AND PAINS

TEMPORARY REDUCTION OF FEVER

TREATMENT/PREVENTION OF CARDIOVASCULAR DISEASE

USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO

TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)

METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER WITH INTRAVENOUS IBUPROFEN

SUCH THAT MEAN ARTERIAL BLOOD PRESSURE DOES NOT INCREASE THE DOSAGE INTERVAL

TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER

WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)

METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY

REDUCING THE DOSE IN PATIENTS WHO ARE BEING TREATED WITH FLUOXETINE

TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI

(ELUXADOLINE)

MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND -THE-CLOCK, LONG-TERM

OPIOID TREATMENT, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL

NEUROPATHY

IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1

INFECTION IN TREATMENT-NAIVE PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000

AT THE START OF THEARPY

PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER

CHEMOTHERAPY

ROLAPITANT IS APPROVED FOR THE PREVENTION OF DELAYED NAUSEA AND VOMITING (I.E.,

EMESIS) ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY

FOR THE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY

PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING

FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA

MONOTHERAPY OR ADJUNCTIVE THERAPY FOR TREATMENT OF PARTIAL-ONSET SEIZURES AND

APPROVED IN PATIENTS WITH EPILEPSY

FOR CLAIMS 1-3,6-13,16-24 AND 26-32: METHOD OF TREATING ADHD

FOR CLAIMS 1-4,6-14,16-24 AND 26-32: METHOD OF TREATING ADHD IN CHILDREN 6 YEARS

OF AGE AND OLDER AND ADOLESCENTS

ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH

BIPOLAR I DISORDER WITH CARIPRAZINE

TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY

TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN

ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY

PROPHYLAXIS OF ORGAN REJECTION

TREATMENT OF HCV INFECTION USING DISABUVIR

FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL

FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER

(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19

DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS

METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT

WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF

INHIBITION ON PI3K KINASE

METHOD OF TREATING ALLERGIC REACTION VIA INJECTION

METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB

RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID

TREATMENT

PLAQUE PSORIASIS

USE OF BELVIQ (LORCASERIN HYDROCHLORIDE) FOR CHRONIC WEIGHT MANAGEMENT IN PATIENTS

ON A REDUCED-CALORIE DIET AND WHO HAVE ACHIEVED A GREATER THAN OR EQUAL TO 5%

WEIGHT LOSS BY WEEK 12 OF TREATMENT

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

ADB 72 of 73

PATENT USE
U-1763

U-1764

U-1765

U-1766
U-1767
U-1768
U-1769
U-1770
U-1771
U-1772
U-1773
U-1774
U-1775
U-1776
U-1777

U-1778
U-1779
U-1780
U-1781
U-1782
U-1783
U-1784
U-1785
U-1786

U-1787
U-1788
U-1789

U-1790
U-1791

U-1792
U-1793
U-1794
U-1795
U-1796

USE OF BELVIQ (LORCASERIN HYDROCHLORIDE) FOR CHRONIC WEIGHT MANAGEMENT BY

DECREASING FOOD INTAKE IN PATIENTS ON A REDUCED-CALORIE DIET AND WHO HAVE ACHIEVED
GREATER THAN OR EQUAL TO 5% WEIGHT LOSS BY WEEK 12 OF TREATMENT
USE OF BELVIQ (LORCASERIN HYDROCHLORIDE) FOR CHRONIC WEIGHT MANAGEMENT BY INDUCING
SATIETY IN PATIENTS ON A REDUCED-CALORIE DIET AND WHO HAVE ACHIEVED A GREATER THAN
OR EQUAL TO 5% WEIGHT LOSS BY WEEK 12 OF TREATMENT
USE OF BELVIQ (LORCASERIN HYDROCHLORIDE) FOR CHRONIC WEIGHT MANAGEMENT BY TREATING
OBESITY IN PATIENTS ON A REDUCED-CALORIE DIET AND WHO HAVE ACHIEVED A GREATER THAN
OR EQUAL TO 5% WEIGHT LOSS BY WEEK 12 OF TREATMENT
TREATMENT OF HYPERKALEMIA
USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN
PATIENTS AGED 18 YEARS AND OLDER
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN
TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE
DYSFUNCTION OF SCHIZOPHRENIA
ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER
FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH EMPAGLIFLOZIN
LONG - TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC
OBSTRUCTIVE PULMONARY DISEASE (COPD)
USE OF A LOTION CONTAINING HALOBETASOL PROPIONATE FOR THE TREATMENT OF
CORTICOSTEROID-RESPONSIVE
USE OF A LOTION CONTAINING HALOBETASOL PROPIONATE FOR THE TREATMENT OF
CORTICOSTEROID-RESPONSIVE DERMATOSES INCLUDING PSORIASIS
METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA
TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTORE RECEPTOR (EGFR)
T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON
OR AFTER EGFR TKI THERAPY
METHOD FOR TREATING MULTIPLE MYELOMA
METHOD FOR TREATING MULTIPLE MYELOMA WITH ONE OR MORE OTHER THERAPEUTIC AGENTS
METHOD FOR TREATING CANCER, INCLUDING MULTIPLE MYELOMA
RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID
TREATMENT
FOR HEAD LICE INFESTATIONS
METHOD OF TREATING FREQUENT HEARTBURN BY ADMINISTERING AN ESOMEPRAZOLE MAGNESIUM
AS CLAIMED
METHOD OF TREATING FREQUENT HEARTBURN BY ADMINISTERING AN ESOMEPRAZOLE MAGNESIUM
TRIHYDRATE AS CLAIMED
METHOD OF TREATING FREQUENT HEARTBURN BY ADMINISTERING AN ESOMEPRAZOLE MAGNESIUM
FORMULATION AS CLAIMED
TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING
THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE
ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL
DOSE
TREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY
TREATMENT OF PATIENT HAVING DIABETES MELLITUS VIA ORAL INHALATION OF FDKP
MICROPARTICLES COMPRISING INSULIN
METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION
TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN
ETHANOL-FREE TAXANE DILUTED SOLUTION
FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR
NON-HODGKIN'S LYMPHOMA
EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR
CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING
CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS
TREATMENT OF OTIC INFECTION OR INFLAMMATION
TREATMENT OF PEDIATRIC PATIENTS WITH OTITIS MEDIA WITH EFFUSION UNDERGOING
TYMPANOSTOMY TUBE PLACEMENT
REVERSAL OF DRUG-INDUCED NEUROMUSCLUAR BLOCK
REVERSAL OF NEUROMUSCLUAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM
BROMIDE
TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

36TH EDITION - 2016 - APPROVED DRUG PRODUCT LIST

PATENT AND EXCLUSIVITY TERMS

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