Products

Ingredient~DF;Route~Trade_Name~Applicant~Strength~Appl_Type~Appl_No~Product_No~T
E_Code~Approval_Date~RLD~Type~Applicant_Full_Name
BUDESONIDE~AEROSOL, FOAM;RECTAL~UCERIS~SALIX PHARMS INC~2MG/ACTUATION~N~205613~0
01~~Oct 7, 2014~Yes~RX~SALIX PHARMACEUTICALS INC
BETAMETHASONE VALERATE~AEROSOL, FOAM;TOPICAL~BETAMETHASONE VALERATE~PERRIGO~0.12
%~A~078337~001~AB~Nov 26, 2012~No~RX~PERRIGO CO
CLINDAMYCIN PHOSPHATE~AEROSOL, FOAM;TOPICAL~CLINDAMYCIN PHOSPHATE~PERRIGO UK FIN
CO~1%~A~090785~001~AT~Mar 31, 2010~No~RX~PERRIGO UK FINCO LTD PARTNERSHIP
CLOBETASOL PROPIONATE~AEROSOL, FOAM;TOPICAL~CLOBETASOL PROPIONATE~PERRIGO ISRAEL
~0.05%~A~077763~001~AB1~Mar 10, 2008~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
CLOBETASOL PROPIONATE~AEROSOL, FOAM;TOPICAL~CLOBETASOL PROPIONATE~PERRIGO ISRAEL
~0.05%~A~201402~001~AB2~Aug 14, 2012~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
ECONAZOLE NITRATE~AEROSOL, FOAM;TOPICAL~ECOZA~VELDANA MEDICAL SA~1%~N~205175~001
~~Oct 24, 2013~Yes~RX~VELDANA MEDICAL SA
CLINDAMYCIN PHOSPHATE~AEROSOL, FOAM;TOPICAL~EVOCLIN~DELCOR ASSET~1%~N~050801~001
~AT~Oct 22, 2004~Yes~RX~DELCOR ASSET CORP
KETOCONAZOLE~AEROSOL, FOAM;TOPICAL~EXTINA~DELCOR ASSET CORP~2%~N~021738~001~AT~J
un 12, 2007~Yes~RX~DELCOR ASSET CORP
TAZAROTENE~AEROSOL, FOAM;TOPICAL~FABIOR~STIEFEL LABS INC~0.1%~N~202428~001~~May
11, 2012~Yes~RX~STIEFEL LABORATORIES INC
KETOCONAZOLE~AEROSOL, FOAM;TOPICAL~KETOCONAZOLE~PERRIGO ISRAEL~2%~A~091550~001~A
T~Aug 25, 2011~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
BETAMETHASONE VALERATE~AEROSOL, FOAM;TOPICAL~LUXIQ~DELCOR ASSET~0.12%~N~020934~0
01~AB~Feb 28, 1999~Yes~RX~DELCOR ASSET CORP
MINOXIDIL~AEROSOL, FOAM;TOPICAL~MEN'S ROGAINE~JOHNSON AND JOHNSON~5%~N~021812~00
1~~Jan 20, 2006~Yes~OTC~JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
MINOXIDIL~AEROSOL, FOAM;TOPICAL~MINOXIDIL~PERRIGO ISRAEL~5%~A~091344~001~~Apr 28
, 2011~No~OTC~PERRIGO ISRAEL PHARMACEUTICALS LTD
CLOBETASOL PROPIONATE~AEROSOL, FOAM;TOPICAL~OLUX~DELCOR ASSET~0.05%~N~021142~001
~AB1~May 26, 2000~Yes~RX~DELCOR ASSET CORP
CLOBETASOL PROPIONATE~AEROSOL, FOAM;TOPICAL~OLUX E~DELCOR ASSET~0.05%~N~022013~0
01~AB2~Jan 12, 2007~Yes~RX~DELCOR ASSET CORP
CALCIPOTRIENE~AEROSOL, FOAM;TOPICAL~SORILUX~STIEFEL LABS INC~0.005%~N~022563~001
~~Oct 6, 2010~Yes~RX~STIEFEL LABORATORIES INC
DESONIDE~AEROSOL, FOAM;TOPICAL~VERDESO~AQUA PHARMS~0.05%~N~021978~001~~Sep 19, 2
006~Yes~RX~AQUA PHARMACEUTICALS
MINOXIDIL~AEROSOL, FOAM;TOPICAL~WOMEN'S ROGAINE~JOHNSON AND JOHNSON~5%~N~021812~
002~~Feb 28, 2014~Yes~OTC~JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE~AEROSOL, METERED;INHALATION~ADVAIR
HFA~GLAXO GRP LTD~0.045MG/INH;EQ 0.021MG BASE/INH~N~021254~001~~Jun 8, 2006~Yes~
RX~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
HFA~GLAXO GRP LTD~0.115MG/INH;EQ 0.021MG BASE/INH~N~021254~002~~Jun 8, 2006~Yes~
RX~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
HFA~GLAXO GRP LTD~0.23MG/INH;EQ 0.021MG BASE/INH~N~021254~003~~Jun 8, 2006~Yes~R
X~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
FLUNISOLIDE~AEROSOL, METERED;INHALATION~AEROBID~ROCHE PALO~0.25MG/INH~N~018340~0
01~~Aug 17, 1984~No~DISCN~ROCHE PALO ALTO LLC
FLUNISOLIDE~AEROSOL, METERED;INHALATION~AEROSPAN HFA~MEDA PHARMS INC~0.078MG/INH
~N~021247~001~~Jan 27, 2006~Yes~RX~MEDA PHARMACEUTICALS INC
ALBUTEROL~AEROSOL, METERED;INHALATION~ALBUTEROL~ARMSTRONG PHARMS~0.09MG/INH~A~07
2273~001~~Aug 14, 1996~No~DISCN~ARMSTRONG PHARMACEUTICALS INC
ALBUTEROL~AEROSOL, METERED;INHALATION~ALBUTEROL~GENPHARM~0.09MG/INH~A~073045~001
~~Aug 19, 1997~No~DISCN~GENPHARM INC
ALBUTEROL~AEROSOL, METERED;INHALATION~ALBUTEROL~IVAX SUB TEVA PHARMS~0.09MG/INH~
A~073272~001~~Dec 28, 1995~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUT
ICALS USA
ALBUTEROL~AEROSOL, METERED;INHALATION~ALBUTEROL~PLIVA~0.09MG/INH~A~074072~001~~A
ug 1, 1996~No~DISCN~PLIVA INC
METAPROTERENOL SULFATE~AEROSOL, METERED;INHALATION~ALUPENT~BOEHRINGER INGELHEIM~

0.65MG/INH~N~016402~001~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER INGEL
HEIM PHARMACEUTICALS INC
CICLESONIDE~AEROSOL, METERED;INHALATION~ALVESCO~TAKEDA GMBH~0.08MG/INH~N~021658~
002~~Jan 10, 2008~No~RX~TAKEDA GMBH
CICLESONIDE~AEROSOL, METERED;INHALATION~ALVESCO~TAKEDA GMBH~0.16MG/INH~N~021658~
003~~Jan 10, 2008~Yes~RX~TAKEDA GMBH
MOMETASONE FUROATE~AEROSOL, METERED;INHALATION~ASMANEX HFA~MERCK SHARP DOHME~0.1
0MG/INH~N~205641~001~~Apr 25, 2014~No~RX~MERCK SHARP AND DOHME CORP
MOMETASONE FUROATE~AEROSOL, METERED;INHALATION~ASMANEX HFA~MERCK SHARP DOHME~0.2
0MG/INH~N~205641~002~~Apr 25, 2014~Yes~RX~MERCK SHARP AND DOHME CORP
ATROPINE SULFATE~AEROSOL, METERED;INHALATION~ATROPINE SULFATE~US ARMY~EQ 0.36MG
BASE/INH~N~020056~001~~Sep 19, 1990~No~DISCN~UNITED STATES ARMY OFFICE SURGEON G
ENERAL
IPRATROPIUM BROMIDE~AEROSOL, METERED;INHALATION~ATROVENT~BOEHRINGER INGELHEIM~0.
018MG/INH~N~019085~001~~Dec 29, 1986~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTICA
LS INC
IPRATROPIUM BROMIDE~AEROSOL, METERED;INHALATION~ATROVENT HFA~BOEHRINGER INGELHEI
M~0.021MG/INH~N~021527~001~~Nov 27, 2004~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTI
CALS INC
TRIAMCINOLONE ACETONIDE~AEROSOL, METERED;INHALATION~AZMACORT~ABBVIE~0.1MG/INH~N~
018117~001~~Apr 23, 1982~No~DISCN~ABBVIE INC
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;INHALATION~BECLOVENT~GLAXOSMITHKLIN
E~0.042MG/INH~N~018153~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLI
NE
TERBUTALINE SULFATE~AEROSOL, METERED;INHALATION~BRETHAIRE~NOVARTIS~0.2MG/INH~N~0
18762~001~~Aug 17, 1984~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
TERBUTALINE SULFATE~AEROSOL, METERED;INHALATION~BRICANYL~SANOFI AVENTIS US~0.2MG
/INH~N~018000~001~~Mar 19, 1985~No~DISCN~SANOFI AVENTIS US LLC
SODIUM CHLORIDE~AEROSOL, METERED;INHALATION~BRONCHO SALINE~BLAIREX~0.9%~N~019912
~001~~Sep 3, 1992~Yes~OTC~BLAIREX LABORATORIES INC
EPINEPHRINE BITARTRATE~AEROSOL, METERED;INHALATION~BRONITIN MIST~WYETH CONS~0.3M
G/INH~N~016126~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH CONSUMER HEALTH
CARE
EPINEPHRINE~AEROSOL, METERED;INHALATION~BRONKAID MIST~STERLING~0.25MG/INH~N~0168
03~001~~Approved Prior to Jan 1, 1982~No~DISCN~STERLING HEALTH DIV STERLING WINT
HROP INC
ISOETHARINE MESYLATE~AEROSOL, METERED;INHALATION~BRONKOMETER~SANOFI AVENTIS US~0
.34MG/INH~N~012339~007~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US
LLC
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE~AEROSOL, METERED;INHALATION~COMBIVENT~BOE
HRINGER INGELHEIM~EQ 0.09MG BASE/INH;0.018MG/INH~N~020291~001~~Oct 24, 1996~Yes~
RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
DEXAMETHASONE SODIUM PHOSPHATE~AEROSOL, METERED;INHALATION~DEXACORT~UCB INC~EQ 0
.1MG PHOSPHATE/INH~N~013413~001~~Approved Prior to Jan 1, 1982~No~DISCN~UCB INC
FORMOTEROL FUMARATE; MOMETASONE FUROATE~AEROSOL, METERED;INHALATION~DULERA~MERCK
SHARP DOHME~0.005MG/INH;0.1MG/INH~N~022518~001~~Jun 22, 2010~Yes~RX~MERCK SHARP
AND DOHME CORP
FORMOTEROL FUMARATE; MOMETASONE FUROATE~AEROSOL, METERED;INHALATION~DULERA~MERCK
SHARP DOHME~0.005MG/INH;0.2MG/INH~N~022518~002~~Jun 22, 2010~Yes~RX~MERCK SHARP
AND DOHME CORP
ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE~AEROSOL, METERED;INHALATIO
N~DUO-MEDIHALER~3M~0.16MG/INH;0.24MG/INH~N~013296~001~~Approved Prior to Jan 1,
1982~No~DISCN~3M PHARMACEUTICALS INC
EPINEPHRINE~AEROSOL, METERED;INHALATION~EPINEPHRINE~ARMSTRONG PHARMS~0.2MG/INH~A
~087907~001~~May 23, 1984~No~DISCN~ARMSTRONG PHARMACEUTICALS INC
FLUTICASONE PROPIONATE~AEROSOL, METERED;INHALATION~FLOVENT~GLAXOSMITHKLINE~0.044
MG/INH~N~020548~001~~Mar 27, 1996~No~DISCN~GLAXOSMITHKLINE
FLUTICASONE PROPIONATE~AEROSOL, METERED;INHALATION~FLOVENT~GLAXOSMITHKLINE~0.11M
G/INH~N~020548~002~~Mar 27, 1996~No~DISCN~GLAXOSMITHKLINE
FLUTICASONE PROPIONATE~AEROSOL, METERED;INHALATION~FLOVENT~GLAXOSMITHKLINE~0.22M

G/INH~N~020548~003~~Mar 27, 1996~No~DISCN~GLAXOSMITHKLINE
FLUTICASONE PROPIONATE~AEROSOL, METERED;INHALATION~FLOVENT HFA~GLAXO GRP LTD~0.0
44MG/INH~N~021433~003~~May 14, 2004~Yes~RX~GLAXO GROUP LTD DBA GLAXOSMITHKLINE
CROMOLYN SODIUM~AEROSOL, METERED;INHALATION~INTAL~KING PFIZER~0.8MG/INH~N~018887
~001~~Dec 5, 1985~No~DISCN~KING PHARMACEUTICALS INC SUB PFIZER INC
ISOETHARINE MESYLATE~AEROSOL, METERED;INHALATION~ISOETHARINE MESYLATE~ALPHARMA U
S PHARMS~0.34MG/INH~A~087858~001~~Aug 21, 1984~No~DISCN~ALPHARMA US PHARMACEUTIC
ALS DIVISION
ISOPROTERENOL HYDROCHLORIDE~AEROSOL, METERED;INHALATION~ISOPROTERENOL HYDROCHLOR
IDE~3M~0.12MG/INH~N~010375~004~~Approved Prior to Jan 1, 1982~No~DISCN~3M PHARMA
CEUTICALS INC
ISOPROTERENOL HYDROCHLORIDE~AEROSOL, METERED;INHALATION~ISOPROTERENOL HYDROCHLOR
IDE~ALPHARMA US PHARMS~0.12MG/INH~A~085904~001~~Approved Prior to Jan 1, 1982~No
~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
ISOPROTERENOL HYDROCHLORIDE~AEROSOL, METERED;INHALATION~ISUPREL~SANOFI AVENTIS U
S~0.103MG/INH~N~011178~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTI
S US LLC
PIRBUTEROL ACETATE~AEROSOL, METERED;INHALATION~MAXAIR~MEDICIS~EQ 0.2MG BASE/INH~
N~020014~001~~Nov 30, 1992~No~DISCN~MEDICIS PHARMACEUTICAL CORP
PIRBUTEROL ACETATE~AEROSOL, METERED;INHALATION~MAXAIR~VALEANT PHARMS~EQ 0.2MG BA
SE/INH~N~019009~001~~Dec 30, 1986~No~DISCN~VALEANT PHARMACEUTICALS NORTH AMERICA
LLC
ERGOTAMINE TARTRATE~AEROSOL, METERED;INHALATION~MEDIHALER ERGOTAMINE~3M~0.36MG/I
NH~N~012102~001~~Approved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
EPINEPHRINE BITARTRATE~AEROSOL, METERED;INHALATION~MEDIHALER-EPI~3M~0.3MG/INH~N~
010374~003~~Approved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
ISOPROTERENOL SULFATE~AEROSOL, METERED;INHALATION~MEDIHALER-ISO~3M~0.08MG/INH~N~
010375~003~~Approved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
EPINEPHRINE~AEROSOL, METERED;INHALATION~PRIMATENE MIST~WYETH CONS~0.2MG/INH~N~01
6126~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH CONSUMER HEALTHCARE
ALBUTEROL SULFATE~AEROSOL, METERED;INHALATION~PROAIR HFA~TEVA BRANDED PHARM~EQ 0
.09MG BASE/INH~N~021457~001~BX~Oct 29, 2004~Yes~RX~TEVA BRANDED PHARMACEUTICAL P
RODUCTS R AND D INC
ALBUTEROL~AEROSOL, METERED;INHALATION~PROVENTIL~SCHERING~0.09MG/INH~N~017559~001
~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
ALBUTEROL SULFATE~AEROSOL, METERED;INHALATION~PROVENTIL-HFA~3M~EQ 0.09MG BASE/IN
H~N~020503~001~BX~Aug 15, 1996~Yes~RX~3M PHARMACEUTICALS INC
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;INHALATION~QVAR 40~TEVA BRANDED PHA
RM~0.04MG/INH~N~020911~002~~Sep 15, 2000~Yes~RX~TEVA BRANDED PHARMACEUTICAL PROD
UCTS R AND D INC
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;INHALATION~QVAR 80~TEVA BRANDED PHA
RM~0.08MG/INH~N~020911~001~~Sep 15, 2000~Yes~RX~TEVA BRANDED PHARMACEUTICAL PROD
UCTS R AND D INC
SALMETEROL XINAFOATE~AEROSOL, METERED;INHALATION~SEREVENT~GLAXOSMITHKLINE~EQ 0.0
21MG BASE/INH~N~020236~001~~Feb 4, 1994~No~DISCN~GLAXOSMITHKLINE
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE~AEROSOL, METERED;INHALATION~SYMBICORT~
ASTRAZENECA~0.08MG/INH;0.0045MG/INH~N~021929~001~~Jul 21, 2006~Yes~RX~ASTRAZENEC
A LP
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE~AEROSOL, METERED;INHALATION~SYMBICORT~
ASTRAZENECA~0.16MG/INH;0.0045MG/INH~N~021929~002~~Jul 21, 2006~Yes~RX~ASTRAZENEC
A LP
NEDOCROMIL SODIUM~AEROSOL, METERED;INHALATION~TILADE~KING PHARMS~1.75MG/INH~N~01
9660~001~~Dec 30, 1992~No~DISCN~KING PHARMACEUTICALS INC
BITOLTEROL MESYLATE~AEROSOL, METERED;INHALATION~TORNALATE~SANOFI AVENTIS US~0.37
MG/INH~N~018770~001~~Dec 28, 1984~No~DISCN~SANOFI AVENTIS US LLC
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;INHALATION~VANCERIL~SCHERING~0.042M

G/INH~N~017573~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCH
ERING PLOUGH CORP
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;INHALATION~VANCERIL DOUBLE STRENGTH
~SCHERING~0.084MG/INH~N~020486~001~~Dec 24, 1996~No~DISCN~SCHERING CORP
ALBUTEROL~AEROSOL, METERED;INHALATION~VENTOLIN~GLAXOSMITHKLINE~0.09MG/INH~N~0184
73~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
ALBUTEROL SULFATE~AEROSOL, METERED;INHALATION~VENTOLIN HFA~GLAXOSMITHKLINE~EQ 0.
09MG BASE/INH~N~020983~001~BX~Apr 19, 2001~Yes~RX~GLAXOSMITHKLINE INTELLECTUAL P
ROPERTY LTD ENGLAND
LEVALBUTEROL TARTRATE~AEROSOL, METERED;INHALATION~XOPENEX HFA~SUNOVION~EQ 0.045M
G BASE/INH~N~021730~001~~Mar 11, 2005~Yes~RX~SUNOVION PHARMACEUTICALS INC
TALC~AEROSOL, METERED;INTRAPLEURAL~SCLEROSOL~BRYAN~400MG/SPRAY~N~020587~001~~Dec
24, 1997~Yes~RX~BRYAN CORP
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;NASAL~BECONASE~GLAXOSMITHKLINE~0.04
2MG/INH~N~018584~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
TRIAMCINOLONE ACETONIDE~AEROSOL, METERED;NASAL~NASACORT~SANOFI AVENTIS US~0.055M
G/INH~N~019798~001~~Jul 11, 1991~No~DISCN~SANOFI AVENTIS US LLC
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;NASAL~QNASL~TEVA BRANDED PHARM~0.04
MG/ACTUATION~N~202813~002~~Dec 17, 2014~No~RX~TEVA BRANDED PHARMACEUTICAL PRODUC
TS R AND D INC
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;NASAL~QNASL~TEVA BRANDED PHARM~0.08
MG/ACTUATION~N~202813~001~~Mar 23, 2012~Yes~RX~TEVA BRANDED PHARMACEUTICAL PRODU
CTS R AND D INC
BUDESONIDE~AEROSOL, METERED;NASAL~RHINOCORT~ASTRAZENECA~0.032MG/INH~N~020233~001
~~Feb 14, 1994~No~DISCN~ASTRAZENECA LP
BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;NASAL~VANCENASE~SCHERING~0.042MG/IN
H~N~018521~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERIN
G PLOUGH CORP
CICLESONIDE~AEROSOL, METERED;NASAL~ZETONNA~TAKEDA GMBH~0.037MG/INH~N~202129~001~
~Jan 20, 2012~Yes~RX~TAKEDA GMBH
HYDROCORTISONE ACETATE~AEROSOL, METERED;RECTAL~CORTIFOAM~MEDA PHARMS~10%~N~01735
1~001~~Feb 10, 1982~Yes~RX~MEDA PHARMACEUTICALS INC
NITROGLYCERIN~AEROSOL, METERED;SUBLINGUAL~NITROMIST~MIST PHARMS LLC~0.4MG/SPRAY~
N~021780~001~~Nov 2, 2006~Yes~RX~MIST PHARMACEUTICALS LLC
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE~AEROSOL, METERED;TOPICAL~EPIFOAM
~MEDA PHARMS~1%;1%~A~086457~001~BX~Approved Prior to Jan 1, 1982~No~RX~MEDA PHAR
MACEUTICALS INC
CHLORHEXIDINE GLUCONATE~AEROSOL, METERED;TOPICAL~EXIDINE~XTTRIUM~4%~N~019127~001
~~Dec 24, 1984~Yes~OTC~XTTRIUM LABORATORIES INC
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE~AEROSOL, METERED;TOPICAL~HYDROCO
RTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%~VINTAGE PHARMS~1%;1%~A~089440~
001~~May 17, 1988~No~DISCN~VINTAGE PHARMACEUTICALS
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE~AEROSOL, METERED;TOPICAL~PROCTOF
OAM HC~MEDA PHARMS~1%;1%~A~086195~001~BX~Approved Prior to Jan 1, 1982~No~RX~MED
A PHARMACEUTICALS INC
DEXAMETHASONE SODIUM PHOSPHATE~AEROSOL;NASAL~DEXACORT~UCB INC~EQ 0.1MG PHOSPHATE
/INH~N~014242~001~~Approved Prior to Jan 1, 1982~No~DISCN~UCB INC
LIDOCAINE~AEROSOL;ORAL~XYLOCAINE~ASTRAZENECA~10%~N~014394~001~~Approved Prior to
Jan 1, 1982~No~DISCN~ASTRAZENECA LP
NITROGLYCERIN~AEROSOL;SUBLINGUAL~NITROLINGUAL~POHL BOSKAMP~0.4MG/SPRAY~N~018705~
001~~Oct 31, 1985~No~DISCN~POHL BOSKAMP
DEXAMETHASONE~AEROSOL;TOPICAL~AEROSEB-DEX~ALLERGAN HERBERT~0.01% **Federal Regis
ter determination that product was not discontinued or withdrawn for safety or e
fficacy reasons**~A~083296~002~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN
HERBERT DIV ALLERGAN INC
HYDROCORTISONE~AEROSOL;TOPICAL~AEROSEB-HC~ALLERGAN HERBERT~0.5%~A~085805~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~ALLERGAN HERBERT DIV ALLERGAN INC
DEXAMETHASONE~AEROSOL;TOPICAL~DECASPRAY~MERCK~0.04% **Federal Register determina
tion that product was not discontinued or withdrawn for safety or efficacy reaso
ns**~N~012731~002~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC

BACITRACIN ZINC; POLYMYXIN B SULFATE~AEROSOL;TOPICAL~POLYSPORIN~GLAXOSMITHKLINE~
10,000 UNITS/GM;2,000,000 UNITS/GM~N~050167~002~~Mar 1, 1985~No~DISCN~GLAXOSMITH
KLINE
PIPERONYL BUTOXIDE; PYRETHRINS~AEROSOL;TOPICAL~RID MOUSSE~BAYER HEALTHCARE LLC~4
%;EQ 0.33% BASE~N~021043~001~~Mar 7, 2000~No~DISCN~BAYER HEALTHCARE LLC
HEXACHLOROPHENE~AEROSOL;TOPICAL~SEPTISOL~VESTAL LABS~0.23%~N~017424~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~VESTAL LABORATORIES DIV CHEMED CORP
HEXACHLOROPHENE~AEROSOL;TOPICAL~TURGEX~XTTRIUM~3%~N~018375~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~XTTRIUM LABORATORIES INC
NONOXYNOL-9~AEROSOL;VAGINAL~DELFEN~PERSONAL PRODS~12.5%~N~014349~002~~Approved P
rior to Jan 1, 1982~No~DISCN~PERSONAL PRODUCTS CO
CHOLESTYRAMINE~BAR, CHEWABLE;ORAL~CHOLYBAR~PARKE DAVIS~EQ 4GM RESIN/BAR~A~071621
~001~~May 26, 1988~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
CHOLESTYRAMINE~BAR, CHEWABLE;ORAL~CHOLYBAR~PARKE DAVIS~EQ 4GM RESIN/BAR~A~071739
~001~~May 26, 1988~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE~CAPSULE, CAPSULE, DELAYED REL PELLETS,
TABLET;ORAL~LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN~SANDOZ~500MG,N/A,N/A;N
/A,500MG,N/A;N/A,N/A,30MG~A~202588~001~AB~Mar 4, 2014~No~RX~SANDOZ INC
TABLET;ORAL~LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN~TEVA PHARMS USA~500MG,
N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG~A~200218~001~AB~Aug 30, 2013~No~RX~TEVA PHARM
ACEUTICALS USA
TABLET;ORAL~PREVPAC~TAKEDA PHARMS USA~500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG~
N~050757~001~AB~Dec 2, 1997~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
DOXYCYCLINE HYCLATE~CAPSULE, COATED PELLETS;ORAL~DOXYCYCLINE HYCLATE~PLIVA~EQ 10
0MG BASE~A~063187~001~~Jun 30, 1992~No~DISCN~PLIVA INC
LANSOPRAZOLE; NAPROXEN~CAPSULE, DELAYED REL PELLETS, TABLET;ORAL~PREVACID NAPRAP
AC 250 (COPACKAGED)~TAKEDA PHARMS NA~15MG,N/A;N/A,250MG **Federal Register deter
mination that product was not discontinued or withdrawn for safety or efficacy r
easons**~N~021507~002~~Nov 14, 2003~No~DISCN~TAKEDA PHARMACEUTICALS NORTH AMERIC
A INC
AC 375 (COPACKAGED)~TAKEDA PHARMS NA~15MG,N/A;N/A,375MG~N~021507~003~~Nov 14, 20
03~No~DISCN~TAKEDA PHARMACEUTICALS NORTH AMERICA INC
AC 500 (COPACKAGED)~TAKEDA PHARMS NA~15MG,N/A;N/A,500MG~N~021507~004~~Nov 14, 20
03~No~DISCN~TAKEDA PHARMACEUTICALS NORTH AMERICA INC
DULOXETINE HYDROCHLORIDE~CAPSULE, DELAYED REL PELLETS;ORAL~CYMBALTA~LILLY~EQ 20M
G BASE~N~021427~001~AB~Aug 3, 2004~No~RX~ELI LILLY AND CO
G BASE~N~021427~002~AB~Aug 3, 2004~No~RX~ELI LILLY AND CO
G BASE~N~021427~004~AB~Aug 3, 2004~Yes~RX~ELI LILLY AND CO
DIVALPROEX SODIUM~CAPSULE, DELAYED REL PELLETS;ORAL~DEPAKOTE~ABBVIE~EQ 125MG VAL
PROIC ACID~N~019680~001~AB~Sep 12, 1989~Yes~RX~ABBVIE INC
DIDANOSINE~CAPSULE, DELAYED REL PELLETS;ORAL~DIDANOSINE~AUROBINDO PHARMA~125MG~A
~090094~001~AB~Sep 24, 2008~No~RX~AUROBINDO PHARMA LTD
DIDANOSINE~CAPSULE, DELAYED REL PELLETS;ORAL~DIDANOSINE~BARR~200MG~A~077167~001~
AB~Dec 3, 2004~No~RX~BARR LABORATORIES INC

DIDANOSINE~CAPSULE, DELAYED REL PELLETS;ORAL~DIDANOSINE~MYLAN PHARMS INC~125MG~A
~090788~001~AB~Apr 8, 2010~No~RX~MYLAN PHARMACEUTICALS INC
DIVALPROEX SODIUM~CAPSULE, DELAYED REL PELLETS;ORAL~DIVALPROEX SODIUM~DR REDDYS
LABS LTD~EQ 125MG VALPROIC ACID~A~078979~001~AB~Jan 23, 2009~No~RX~DR REDDYS LAB
ORATORIES LTD
DIVALPROEX SODIUM~CAPSULE, DELAYED REL PELLETS;ORAL~DIVALPROEX SODIUM~MYLAN~EQ 1
25MG VALPROIC ACID~A~090407~001~AB~Mar 28, 2011~No~RX~MYLAN PHARMACEUTICALS INC
DIVALPROEX SODIUM~CAPSULE, DELAYED REL PELLETS;ORAL~DIVALPROEX SODIUM~ZYDUS PHAR
MS USA INC~EQ 125MG VALPROIC ACID~A~078919~001~AB~Jan 27, 2009~No~RX~ZYDUS PHARM
ACEUTICALS USA INC
DULOXETINE HYDROCHLORIDE~CAPSULE, DELAYED REL PELLETS;ORAL~DULOXETINE HYDROCHLOR
IDE~ACTAVIS ELIZABETH~EQ 20MG BASE~A~090776~001~AB~Dec 17, 2013~No~RX~ACTAVIS EL
IZABETH LLC
IZABETH LLC
IZABETH LLC
IDE~ALEMBIC PHARMS LTD~EQ 20MG BASE~A~202949~001~AB~Jun 9, 2014~No~RX~ALEMBIC PH
ARMACEUTICALS LTD
ARMACEUTICALS LTD
ARMACEUTICALS LTD
IDE~APOTEX INC~EQ 20MG BASE~A~202045~001~AB~Jun 11, 2014~No~RX~APOTEX INC
IDE~AUROBINDO PHARMA LTD~EQ 20MG BASE~A~090778~001~AB~Dec 11, 2013~No~RX~AUROBIN
DO PHARMA LTD
DO PHARMA LTD
DO PHARMA LTD
IDE~BRECKENRIDGE PHARM~EQ 20MG BASE~A~203088~001~AB~Jun 11, 2014~No~RX~BRECKENRI
DGE PHARMACEUTICAL INC
IDE~DR REDDYS LABS LTD~EQ 20MG BASE~A~090723~001~AB~Dec 11, 2013~No~RX~DR REDDYS

LABORATORIES LTD
LABORATORIES LTD
LABORATORIES LTD
IDE~LUPIN LTD~EQ 20MG BASE~A~090694~001~AB~Dec 11, 2013~No~RX~LUPIN LTD
IDE~LUPIN LTD~EQ 40MG BASE~A~090694~003~~Dec 11, 2013~No~RX~LUPIN LTD
IDE~SUN PHARMA GLOBAL~EQ 20MG BASE~A~090745~001~AB~Dec 11, 2013~No~RX~SUN PHARMA
GLOBAL FZE
GLOBAL FZE
GLOBAL FZE
IDE~TEVA PHARMS USA~EQ 20MG BASE~A~090783~001~AB~Dec 11, 2013~No~RX~TEVA PHARMAC
EUTICALS USA
EUTICALS USA
EUTICALS USA
IDE~TORRENT PHARMS LTD~EQ 20MG BASE~A~090774~001~AB~Dec 11, 2013~No~RX~TORRENT P
HARMACEUTICALS LTD
HARMACEUTICALS LTD
HARMACEUTICALS LTD
IDE~ZYDUS PHARMS USA INC~EQ 20MG BASE~A~090728~001~AB~Jan 8, 2014~No~RX~ZYDUS PH
ARMACEUTICALS USA INC

ERYTHROMYCIN~CAPSULE, DELAYED REL PELLETS;ORAL~ERYC~MAYNE PHARMA~250MG~N~050536~
001~AB~Approved Prior to Jan 1, 1982~Yes~RX~MAYNE PHARMA INTERNATIONAL PTY LTD
ERYTHROMYCIN~CAPSULE, DELAYED REL PELLETS;ORAL~ERYC~PARKE DAVIS~250MG~A~062546~0
01~~Jul 25, 1985~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
ERYTHROMYCIN~CAPSULE, DELAYED REL PELLETS;ORAL~ERYC~PARKE DAVIS~250MG~A~062618~0
01~~Sep 25, 1985~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
ERYTHROMYCIN~CAPSULE, DELAYED REL PELLETS;ORAL~ERYC~WARNER CHILCOTT LLC~250MG~A~
062338~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT CO LLC
ERYTHROMYCIN~CAPSULE, DELAYED REL PELLETS;ORAL~ERYC 125~PARKE DAVIS~125MG~A~0626
48~001~~Oct 24, 1985~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
ERYTHROMYCIN~CAPSULE, DELAYED REL PELLETS;ORAL~ERYC SPRINKLES~HOSPIRA~125MG~N~05
0593~001~~Jul 22, 1985~No~DISCN~HOSPIRA INC
ERYTHROMYCIN~CAPSULE, DELAYED REL PELLETS;ORAL~ERYTHROMYCIN~ARBOR PHARMS LLC~250
MG~A~062746~001~AB~Dec 22, 1986~No~RX~ARBOR PHARMACEUTICALS LLC
ERYTHROMYCIN~CAPSULE, DELAYED REL PELLETS;ORAL~ERYTHROMYCIN~BARR~250MG~A~063098~
001~~May 4, 1989~No~DISCN~BARR LABORATORIES INC
ESOMEPRAZOLE MAGNESIUM~CAPSULE, DELAYED REL PELLETS;ORAL~ESOMEPRAZOLE MAGNESIUM~
IVAX SUB TEVA PHARMS~EQ 20MG BASE~A~078003~001~AB~Jan 26, 2015~No~RX~IVAX PHARMA
CEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ESOMEPRAZOLE MAGNESIUM~CAPSULE, DELAYED REL PELLETS;ORAL~ESOMEPRAZOLE MAGNESIUM~
IVAX SUB TEVA PHARMS~EQ 40MG BASE~A~078003~002~AB~Jan 26, 2015~No~RX~IVAX PHARMA
FLUOXETINE HYDROCHLORIDE~CAPSULE, DELAYED REL PELLETS;ORAL~FLUOXETINE HYDROCHLOR
IDE~BARR~EQ 90MG BASE~A~076237~001~AB~Mar 24, 2010~No~RX~BARR LABORATORIES INC
FLUOXETINE HYDROCHLORIDE~CAPSULE, DELAYED REL PELLETS;ORAL~FLUOXETINE HYDROCHLOR
IDE~DR REDDYS LABS LTD~EQ 90MG BASE~A~078572~001~AB~Mar 22, 2010~No~RX~DR REDDYS
LABORATORIES LTD
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~DR REDDYS LABS LTD~1
5MG~A~091269~001~AB~Oct 15, 2010~No~RX~DR REDDYS LABORATORIES LTD
5MG~A~202194~001~~May 18, 2012~No~OTC~DR REDDYS LABORATORIES LTD
0MG~A~091269~002~AB~Oct 15, 2010~No~RX~DR REDDYS LABORATORIES LTD
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~MYLAN PHARMS INC~15M
G~A~090763~001~AB~Nov 10, 2009~No~RX~MYLAN PHARMACEUTICALS INC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~MYLAN PHARMS INC~30M
G~A~090763~002~AB~Nov 10, 2009~No~RX~MYLAN PHARMACEUTICALS INC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~NATCO PHARMA LTD~15M
G~A~201921~001~AB~Dec 18, 2012~No~RX~NATCO PHARMA LTD
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~NATCO PHARMA LTD~30M
G~A~201921~002~AB~Dec 18, 2012~No~RX~NATCO PHARMA LTD
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~PERRIGO R AND D~15MG
~A~202319~001~~May 18, 2012~No~OTC~PERRIGO R AND D CO
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~SANDOZ~15MG~A~090331
~001~AB~Apr 23, 2010~No~RX~SANDOZ INC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~SANDOZ~30MG~A~090331
~002~AB~Apr 23, 2010~No~RX~SANDOZ INC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~SUN PHARMA GLOBAL~15
MG~A~202637~001~AB~Sep 13, 2013~No~RX~SUN PHARMA GLOBAL FZE
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~SUN PHARMA GLOBAL~30
MG~A~091509~001~AB~Sep 13, 2013~No~RX~SUN PHARMA GLOBAL FZE
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~TEVA PHARMS~15MG~A~0
77255~001~AB~Nov 10, 2009~No~RX~TEVA PHARMACEUTICALS USA
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~TEVA PHARMS~30MG~A~0
77255~002~AB~Nov 10, 2009~No~RX~TEVA PHARMACEUTICALS USA
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~WOCKHARDT LTD~15MG~A
~202727~001~~May 18, 2012~No~OTC~WOCKHARDT LTD
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~WOCKHARDT USA~15MG~A
~202176~001~AB~Sep 14, 2012~No~RX~WOCKHARDT USA LLC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~WOCKHARDT USA~30MG~A

~202176~002~AB~Sep 14, 2012~No~RX~WOCKHARDT USA LLC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~ZYDUS HLTHCARE~15MG~
A~202366~001~AB~Aug 19, 2013~No~RX~ZYDUS HEALTHCARE USA LLC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~ZYDUS HLTHCARE~30MG~
A~202366~002~AB~Aug 19, 2013~No~RX~ZYDUS HEALTHCARE USA LLC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE ~KRKA TOVARNA ZDRAVI
L~15MG~A~091212~001~AB~Sep 16, 2013~No~RX~KRKA TOVARNA ZDRAVIL DD NOVO MESTO
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE ~KRKA TOVARNA ZDRAVI
L~30MG~A~091212~002~AB~Sep 16, 2013~No~RX~KRKA TOVARNA ZDRAVIL DD NOVO MESTO
ESOMEPRAZOLE MAGNESIUM~CAPSULE, DELAYED REL PELLETS;ORAL~NEXIUM~ASTRAZENECA PHAR
MS~EQ 20MG BASE~N~021153~001~AB~Feb 20, 2001~No~RX~ASTRAZENECA PHARMACEUTICALS L
P
ESOMEPRAZOLE MAGNESIUM~CAPSULE, DELAYED REL PELLETS;ORAL~NEXIUM~ASTRAZENECA PHAR
MS~EQ 40MG BASE~N~021153~002~AB~Feb 20, 2001~Yes~RX~ASTRAZENECA PHARMACEUTICALS
LP
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~ACTAVIS LABS FL INC~10MG
~A~075347~001~AB~May 30, 2008~No~RX~ACTAVIS LABORATORIES FL INC
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~APOTEX~10MG~A~076048~001
~AB~Oct 22, 2007~No~RX~APOTEX INC
~AB~Oct 22, 2007~No~RX~APOTEX INC
~AB~Jan 21, 2009~No~RX~APOTEX INC
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~DR REDDYS LABS LTD~10MG~
A~075576~003~AB~Oct 22, 2007~No~RX~DR REDDYS LABORATORIES LTD
A~078490~002~AB~Mar 16, 2009~No~RX~DR REDDYS LABORATORIES LTD
A~078490~003~AB~Mar 16, 2009~No~RX~DR REDDYS LABORATORIES LTD
A~075576~001~AB~Jan 21, 2009~No~RX~DR REDDYS LABORATORIES LTD
A~078490~001~AB~Apr 17, 2009~No~RX~DR REDDYS LABORATORIES LTD
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~GLENMARK GENERICS~10MG~A
~091672~001~AB~Oct 31, 2014~No~RX~GLENMARK GENERICS LTD
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~IMPAX LABS~10MG~A~075785
~001~AB~Oct 22, 2007~No~RX~IMPAX LABORATORIES INC
~002~AB~Oct 22, 2007~No~RX~IMPAX LABORATORIES INC
~003~AB~Jan 21, 2009~No~RX~IMPAX LABORATORIES INC
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~KREMERS URBAN PHARMS~10M
G~A~075410~001~AB~Nov 1, 2002~No~RX~KREMERS URBAN PHARMACEUTICALS INC
G~A~075410~002~AB~Nov 1, 2002~No~RX~KREMERS URBAN PHARMACEUTICALS INC
G~A~075410~003~AB~Jan 23, 2009~No~RX~KREMERS URBAN PHARMACEUTICALS INC
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~MYLAN~10MG~A~075876~001~
AB~May 29, 2003~No~RX~MYLAN PHARMACEUTICALS INC

AB~May 29, 2003~No~RX~MYLAN PHARMACEUTICALS INC
AB~Jan 21, 2009~No~RX~MYLAN PHARMACEUTICALS INC
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~SANDOZ~10MG~A~075757~001
~AB~Jan 28, 2003~No~RX~SANDOZ INC
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~ZYDUS PHARMS USA INC~10M
G~A~091352~001~AB~Nov 19, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~PREVACID~TAKEDA PHARMS USA~15MG~N
~020406~001~AB~May 10, 1995~No~RX~TAKEDA PHARMACEUTICALS USA INC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~PREVACID~TAKEDA PHARMS USA~30MG~N
~020406~002~AB~May 10, 1995~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~PREVACID 24 HR~NOVARTIS~15MG~N~02
2327~001~~May 18, 2009~Yes~OTC~NOVARTIS CONSUMER HEALTH INC
OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~PRILOSEC~ASTRAZENECA PHARMS~10MG~N~
019810~003~AB~Oct 5, 1995~No~RX~ASTRAZENECA PHARMACEUTICALS LP
019810~001~AB~Sep 14, 1989~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
019810~002~AB~Jan 15, 1998~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
FLUOXETINE HYDROCHLORIDE~CAPSULE, DELAYED REL PELLETS;ORAL~PROZAC WEEKLY~LILLY~E
Q 90MG BASE~N~021235~001~AB~Feb 26, 2001~Yes~RX~ELI LILLY AND CO
DIDANOSINE~CAPSULE, DELAYED REL PELLETS;ORAL~VIDEX EC~BRISTOL MYERS SQUIBB~125MG
~N~021183~001~AB~Oct 31, 2000~No~RX~BRISTOL MYERS SQUIBB CO
~N~021183~004~AB~Oct 31, 2000~Yes~RX~BRISTOL MYERS SQUIBB CO
RABEPRAZOLE SODIUM~CAPSULE, DELAYED RELEASE;ORAL~ACIPHEX SPRINKLE~EISAI INC~5MG~
N~204736~001~~Mar 26, 2013~No~RX~EISAI INC
RABEPRAZOLE SODIUM~CAPSULE, DELAYED RELEASE;ORAL~ACIPHEX SPRINKLE~EISAI INC~10MG
~N~204736~002~~Mar 26, 2013~Yes~RX~EISAI INC
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~CAPSULE, DELAYED RELEASE;ORAL~CREON~ABBVI
E~60,000USP UNITS;12,000USP UNITS;38,000USP UNITS~N~020725~002~~Apr 30, 2009~No~
RX~ABBVIE INC
E~15,000USP UNITS;3,000USP UNITS;9,500USP UNITS~N~020725~004~~Jul 12, 2011~No~RX
~ABBVIE INC
E~30,000USP UNITS;6,000USP UNITS;19,000USP UNITS~N~020725~001~~Apr 30, 2009~No~R
X~ABBVIE INC
E~180,000USP UNITS;36,000USP UNITS;114,000USP UNITS~N~020725~005~~Mar 14, 2013~N
o~RX~ABBVIE INC
E~120,000USP UNITS;24,000USP UNITS;76,000USP UNITS~N~020725~003~~Apr 30, 2009~Ye
s~RX~ABBVIE INC
MESALAMINE~CAPSULE, DELAYED RELEASE;ORAL~DELZICOL~WARNER CHILCOTT LLC~400MG~N~20
4412~001~~Feb 1, 2013~Yes~RX~WARNER CHILCOTT CO LLC
DEXLANSOPRAZOLE~CAPSULE, DELAYED RELEASE;ORAL~DEXILANT~TAKEDA PHARMS USA~30MG~N~
022287~001~~Jan 30, 2009~No~RX~TAKEDA PHARMACEUTICALS USA INC

DEXLANSOPRAZOLE~CAPSULE, DELAYED RELEASE;ORAL~DEXILANT~TAKEDA PHARMS USA~60MG~N~
022287~002~~Jan 30, 2009~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
DOXYCYCLINE HYCLATE~CAPSULE, DELAYED RELEASE;ORAL~DORYX~MAYNE PHARMA INTL~EQ 75M
G BASE~N~050582~002~~Aug 13, 2001~No~DISCN~MAYNE PHARMA INTERNATIONAL FAULDING P
HARM
DOXYCYCLINE HYCLATE~CAPSULE, DELAYED RELEASE;ORAL~DORYX~MAYNE PHARMA INTL~EQ 100
MG BASE~N~050582~001~~Jul 22, 1985~No~DISCN~MAYNE PHARMA INTERNATIONAL FAULDING
PHARM
DOXYCYCLINE HYCLATE~CAPSULE, DELAYED RELEASE;ORAL~DORYX~WARNER CHILCOTT~EQ 100MG
BASE~A~062653~001~~Oct 30, 1985~No~DISCN~WARNER CHILCOTT BERMUDA LTD
DOXYCYCLINE HYCLATE~CAPSULE, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~MEDICIS~EQ
75MG BASE~A~065281~001~~Dec 21, 2005~No~RX~MEDICIS PHARMACEUTICAL CORP
DOXYCYCLINE HYCLATE~CAPSULE, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~MEDICIS~EQ
100MG BASE~A~065281~002~~Dec 21, 2005~Yes~RX~MEDICIS PHARMACEUTICAL CORP
ESOMEPRAZOLE STRONTIUM~CAPSULE, DELAYED RELEASE;ORAL~ESOMEPRAZOLE STRONTIUM~HANM
I PHARM CO LTD~EQ 20MG BASE~N~202342~001~~Aug 6, 2013~No~RX~HANMI PHARMACEUTICAL
CO LTD
ESOMEPRAZOLE STRONTIUM~CAPSULE, DELAYED RELEASE;ORAL~ESOMEPRAZOLE STRONTIUM~HANM
I PHARM CO LTD~EQ 40MG BASE~N~202342~002~~Aug 6, 2013~Yes~RX~HANMI PHARMACEUTICA
L CO LTD
CHOLINE FENOFIBRATE~CAPSULE, DELAYED RELEASE;ORAL~FENOFIBRIC ACID~ANCHEN PHARMS~
EQ 45MG FENOFIBRIC ACID~A~201573~002~AB~Jul 18, 2013~No~RX~ANCHEN PHARMACEUTICAL
S INC
CHOLINE FENOFIBRATE~CAPSULE, DELAYED RELEASE;ORAL~FENOFIBRIC ACID~ANCHEN PHARMS~
EQ 135MG FENOFIBRIC ACID~A~201573~001~AB~Jul 18, 2013~No~RX~ANCHEN PHARMACEUTICA
LS INC
CHOLINE FENOFIBRATE~CAPSULE, DELAYED RELEASE;ORAL~FENOFIBRIC ACID~LUPIN LTD~EQ 4
5MG FENOFIBRIC ACID~A~200750~001~AB~Dec 4, 2013~No~RX~LUPIN LTD
CHOLINE FENOFIBRATE~CAPSULE, DELAYED RELEASE;ORAL~FENOFIBRIC ACID~LUPIN LTD~EQ 1
35MG FENOFIBRIC ACID~A~200750~002~AB~Dec 4, 2013~No~RX~LUPIN LTD
CHOLINE FENOFIBRATE~CAPSULE, DELAYED RELEASE;ORAL~FENOFIBRIC ACID~MYLAN PHARMS I
NC~EQ 45MG FENOFIBRIC ACID~A~200913~001~AB~Mar 25, 2013~No~RX~MYLAN PHARMACEUTIC
ALS INC
CHOLINE FENOFIBRATE~CAPSULE, DELAYED RELEASE;ORAL~FENOFIBRIC ACID~MYLAN PHARMS I
NC~EQ 135MG FENOFIBRIC ACID~A~200913~002~AB~Mar 25, 2013~No~RX~MYLAN PHARMACEUTI
CALS INC
ESOMEPRAZOLE MAGNESIUM~CAPSULE, DELAYED RELEASE;ORAL~NEXIUM 24HR~ASTRAZENECA LP~
EQ 20MG BASE~N~204655~001~~Mar 28, 2014~Yes~OTC~ASTRAZENECA LP
OMEPRAZOLE MAGNESIUM~CAPSULE, DELAYED RELEASE;ORAL~OMEPRAZOLE MAGNESIUM~DR REDDY
S LABS LTD~EQ 20MG BASE~A~078878~001~~Jun 5, 2009~Yes~OTC~DR REDDYS LABORATORIES
LTD
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~CAPSULE, DELAYED RELEASE;ORAL~PANCREAZE~J
ANSSEN PHARMS~10,850USP UNITS;2,600USP UNITS;6,200USP UNITS~N~022523~005~~Mar 7,
2014~No~RX~JANSSEN PHARMACEUTICALS INC
ANSSEN PHARMS~17,500USP/ UNITS;4,200USP/ UNITS;10,000USP/ UNITS~N~022523~001~~Ap
r 12, 2010~No~RX~JANSSEN PHARMACEUTICALS INC
ANSSEN PHARMS~43,750USP/ UNITS;10,500USP/ UNITS;25,000USP/ UNITS~N~022523~002~~A
pr 12, 2010~No~RX~JANSSEN PHARMACEUTICALS INC
pr 12, 2010~Yes~RX~JANSSEN PHARMACEUTICALS INC
pr 12, 2010~No~RX~JANSSEN PHARMACEUTICALS INC
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~CAPSULE, DELAYED RELEASE;ORAL~PERTZYE~DIG
ESTIVE CARE INC~30,250USP UNITS;8,000USP UNITS;28,750USP UNITS~N~022175~001~~May
17, 2012~No~RX~DIGESTIVE CARE INC
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~CAPSULE, DELAYED RELEASE;ORAL~PERTZYE~DIG

ESTIVE CARE INC~60,500USP UNITS;16,000USP UNITS;57,500USP UNITS~N~022175~002~~Ma
y 17, 2012~Yes~RX~DIGESTIVE CARE INC
CYSTEAMINE BITARTRATE~CAPSULE, DELAYED RELEASE;ORAL~PROCYSBI~RAPTOR INC~EQ 25MG
BASE~N~203389~001~~Apr 30, 2013~No~RX~RAPTOR PHARMACEUTICALS INC
CYSTEAMINE BITARTRATE~CAPSULE, DELAYED RELEASE;ORAL~PROCYSBI~RAPTOR INC~EQ 75MG
BASE~N~203389~002~~Apr 30, 2013~Yes~RX~RAPTOR PHARMACEUTICALS INC
VALPROIC ACID~CAPSULE, DELAYED RELEASE;ORAL~STAVZOR~BANNER LIFE SCIENCES~125MG~N
~022152~001~~Jul 29, 2008~No~DISCN~BANNER LIFE SCIENCES LLC
DIMETHYL FUMARATE~CAPSULE, DELAYED RELEASE;ORAL~TECFIDERA~BIOGEN IDEC INC~120MG~
N~204063~001~~Mar 27, 2013~No~RX~BIOGEN IDEC INC
DIMETHYL FUMARATE~CAPSULE, DELAYED RELEASE;ORAL~TECFIDERA~BIOGEN IDEC INC~240MG~
N~204063~002~~Mar 27, 2013~Yes~RX~BIOGEN IDEC INC
CHOLINE FENOFIBRATE~CAPSULE, DELAYED RELEASE;ORAL~TRILIPIX~ABBVIE~EQ 45MG FENOFI
BRIC ACID~N~022224~001~AB~Dec 15, 2008~No~RX~ABBVIE INC
CHOLINE FENOFIBRATE~CAPSULE, DELAYED RELEASE;ORAL~TRILIPIX~ABBVIE~EQ 135MG FENOF
IBRIC ACID~N~022224~002~AB~Dec 15, 2008~Yes~RX~ABBVIE INC
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~CAPSULE, DELAYED RELEASE;ORAL~ULTRESA~FOR
EST LABS INC~27,600USP UNITS;13,800USP UNITS;27,600USP UNITS~N~022222~001~~Mar 1
, 2012~No~RX~FOREST LABORATORIES INC
, 2012~Yes~RX~FOREST LABORATORIES INC
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~CAPSULE, DELAYED RELEASE;ORAL~ZENPEP~FORE
ST LABS INC~218,000USP UNITS; 40,00USP UNITS; 136,000 USP UNITS~N~022210~007~~Ma
r 25, 2014~No~RX~FOREST LABORATORIES INC
ST LABS INC~16,000USP UNITS;3,000USP UNITS;10,000USP UNITS~N~022210~005~~Jun 15,
2011~No~RX~FOREST LABORATORIES INC
ST LABS INC~55,000USP UNITS;10,000USP UNITS;34,000USP UNITS~N~022210~002~~Aug 27
ST LABS INC~27,000USP UNITS;5,000USP UNITS;17,000USP UNITS~N~022210~001~~Aug 27,
7, 2009~No~RX~FOREST LABORATORIES INC
ST LABS INC~136,000USP UNITS;25,000USP UNITS;85,000USP UNITS~N~022210~006~~Jul 1
3, 2011~Yes~RX~FOREST LABORATORIES INC
ACETAZOLAMIDE~CAPSULE, EXTENDED RELEASE;ORAL~ACETAZOLAMIDE~HERITAGE PHARMS INC~5
00MG~A~090779~001~AB~Jul 14, 2011~No~RX~HERITAGE PHARMACEUTICALS INC
ACETAZOLAMIDE~CAPSULE, EXTENDED RELEASE;ORAL~ACETAZOLAMIDE~ZYDUS PHARMS USA INC~
500MG~A~040904~001~AB~Dec 10, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~CAPSULE, EXTENDED RELE
ASE;ORAL~ACTIFED~GLAXOSMITHKLINE~120MG;5MG~N~018996~001~~Jun 17, 1985~No~DISCN~G
LAXOSMITHKLINE
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTRO
AMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~ADDERALL XR 10~SHIRE~2.5MG;2.
5MG;2.5MG;2.5MG~N~021303~001~AB~Oct 11, 2001~No~RX~SHIRE DEVELOPMENT INC

AMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~ADDERALL XR 15~SHIRE~3.75MG;3
.75MG;3.75MG;3.75MG~N~021303~006~AB~May 22, 2002~No~RX~SHIRE DEVELOPMENT INC
AMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~ADDERALL XR 20~SHIRE~5MG;5MG;
5MG;5MG~N~021303~002~AB~Oct 11, 2001~No~RX~SHIRE DEVELOPMENT INC
AMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~ADDERALL XR 25~SHIRE~6.25MG;6
.25MG;6.25MG;6.25MG~N~021303~004~AB~May 22, 2002~No~RX~SHIRE DEVELOPMENT INC
5MG;7.5MG;7.5MG~N~021303~003~AB~Oct 11, 2001~Yes~RX~SHIRE DEVELOPMENT INC
25MG;1.25MG;1.25MG~N~021303~005~AB~May 22, 2002~No~RX~SHIRE DEVELOPMENT INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~AEROLATE III~FLEMING PHARMS~65MG~A~0
85075~003~~Nov 24, 1986~No~DISCN~FLEMING AND CO PHARMACEUTICALS INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~AEROLATE JR~FLEMING PHARMS~130MG~A~0
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~AEROLATE SR~FLEMING PHARMS~260MG~A~0
ASPIRIN; DIPYRIDAMOLE~CAPSULE, EXTENDED RELEASE;ORAL~AGGRENOX~BOEHRINGER INGELHE
IM~25MG;200MG~N~020884~001~AB~Nov 22, 1999~Yes~RX~BOEHRINGER INGELHEIM PHARMACEU
TICALS INC
AMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~AMPHETAMINE ASP AMPHETAMINE S
ULF DEXTROAMPHET SACCHARATE & DEXTR SULF~TEVA~1.25MG;1.25MG;1.25MG;1.25MG~A~0774
88~001~AB~Apr 29, 2013~No~RX~TEVA PHARMACEUTICALS USA INC
ULF DEXTROAMPHET SACCHARATE & DEXTR SULF~TEVA~2.5MG;2.5MG;2.5MG;2.5MG~A~077488~0
02~AB~Apr 29, 2013~No~RX~TEVA PHARMACEUTICALS USA INC
ULF DEXTROAMPHET SACCHARATE & DEXTR SULF~TEVA~5MG;5MG;5MG;5MG~A~077488~004~AB~Ap
r 29, 2013~No~RX~TEVA PHARMACEUTICALS USA INC
ULF DEXTROAMPHET SACCHARATE & DEXTR SULF~TEVA~7.5MG;7.5MG;7.5MG;7.5MG~A~077488~0
06~AB~Apr 29, 2013~No~RX~TEVA PHARMACEUTICALS USA INC
CYCLOBENZAPRINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~AMRIX~IVAX INTL~15M
G~N~021777~001~AB~Feb 1, 2007~No~RX~IVAX INTERNATIONAL GMBH
CYCLOBENZAPRINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~AMRIX~IVAX INTL~30M
G~N~021777~002~AB~Feb 1, 2007~Yes~RX~IVAX INTERNATIONAL GMBH
MESALAMINE~CAPSULE, EXTENDED RELEASE;ORAL~APRISO~SALIX PHARMS~375MG~N~022301~001
~~Oct 31, 2008~Yes~RX~SALIX PHARMACEUTICALS INC
TRIHEXYPHENIDYL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~ARTANE~LEDERLE~5MG~
N~006773~010~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AM
ERICAN CYANAMID CO
TRIHEXYPHENIDYL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~ARTANE~LEDERLE~5MG~
N~012947~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AM
ERICAN CYANAMID CO
ASPIRIN; DIPYRIDAMOLE~CAPSULE, EXTENDED RELEASE;ORAL~ASPIRIN AND DIPYRIDAMOLE~BA
RR~25MG;200MG~A~078804~001~AB~Aug 14, 2009~No~RX~BARR LABORATORIES INC
TACROLIMUS~CAPSULE, EXTENDED RELEASE;ORAL~ASTAGRAF XL~ASTELLAS~EQ 0.5MG BASE~N~2
04096~001~~Jul 19, 2013~No~RX~ASTELLAS PHARMA US INC
TACROLIMUS~CAPSULE, EXTENDED RELEASE;ORAL~ASTAGRAF XL~ASTELLAS~EQ 1MG BASE~N~204
096~002~~Jul 19, 2013~No~RX~ASTELLAS PHARMA US INC
TACROLIMUS~CAPSULE, EXTENDED RELEASE;ORAL~ASTAGRAF XL~ASTELLAS~EQ 5MG BASE~N~204
096~003~~Jul 19, 2013~Yes~RX~ASTELLAS PHARMA US INC
MORPHINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~AVINZA~KING PHARMS LLC~30MG~N~02
1260~001~AB2~Mar 20, 2002~No~RX~KING PHARMACEUTICALS LLC
1260~005~AB2~Dec 18, 2008~No~RX~KING PHARMACEUTICALS LLC
1260~006~AB2~Dec 18, 2008~No~RX~KING PHARMACEUTICALS LLC
21260~004~AB2~Mar 20, 2002~Yes~RX~KING PHARMACEUTICALS LLC
AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX~CAPSULE, EXTENDED REL
EASE;ORAL~BIPHETAMINE 12.5~UCB INC~EQ 6.25MG BASE;EQ 6.25MG BASE~N~010093~007~~A
pproved Prior to Jan 1, 1982~No~DISCN~UCB INC
EASE;ORAL~BIPHETAMINE 20~UCB INC~EQ 10MG BASE;EQ 10MG BASE~N~010093~003~~Approve
d Prior to Jan 1, 1982~No~DISCN~UCB INC
EASE;ORAL~BIPHETAMINE 7.5~UCB INC~EQ 3.75MG BASE;EQ 3.75MG BASE~N~010093~009~~Ap
proved Prior to Jan 1, 1982~No~DISCN~UCB INC
PHENDIMETRAZINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~BONTRIL~VALEANT~105MG~A~
088021~001~~Sep 21, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
CARBAMAZEPINE~CAPSULE, EXTENDED RELEASE;ORAL~CARBAMAZEPINE~APOTEX INC~100MG~A~07
8986~001~AB~Nov 25, 2011~No~RX~APOTEX INC
CARBAMAZEPINE~CAPSULE, EXTENDED RELEASE;ORAL~CARBAMAZEPINE~NOSTRUM~100MG~A~07669
7~001~AB~May 20, 2011~No~RX~NOSTRUM PHARMACEUTICALS INC
CARBAMAZEPINE~CAPSULE, EXTENDED RELEASE;ORAL~CARBAMAZEPINE~TARO~100MG~A~201106~0
01~AB~Jun 21, 2013~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
CARBAMAZEPINE~CAPSULE, EXTENDED RELEASE;ORAL~CARBAMAZEPINE~TEVA PHARMS~100MG~A~0
78592~001~AB~Sep 20, 2012~No~RX~TEVA PHARMACEUTICALS USA
CARBAMAZEPINE~CAPSULE, EXTENDED RELEASE;ORAL~CARBATROL~SHIRE~100MG~N~020712~003~
AB~Sep 30, 1997~No~RX~SHIRE DEVELOPMENT INC
AB~Sep 30, 1997~No~RX~SHIRE DEVELOPMENT INC

AB~Sep 30, 1997~Yes~RX~SHIRE DEVELOPMENT INC
NICARDIPINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CARDENE SR~CHIESI USA I
NC~30MG~N~020005~001~~Feb 21, 1992~No~DISCN~CHIESI USA INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CARDIZEM CD~VALEANT INTL~
120MG~N~020062~001~AB3~Aug 10, 1992~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
180MG~N~020062~002~AB3~Dec 27, 1991~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
360MG~N~020062~005~AB3~Aug 24, 1999~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CARDIZEM SR~BIOVAIL~60MG~
N~019471~001~~Jan 23, 1989~No~DISCN~BIOVAIL LABORATORIES INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CARDIZEM SR~BIOVAIL~90MG~
N~019471~002~~Jan 23, 1989~No~DISCN~BIOVAIL LABORATORIES INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CARDIZEM SR~BIOVAIL~120MG
~N~019471~003~~Jan 23, 1989~No~DISCN~BIOVAIL LABORATORIES INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CARDIZEM SR~BIOVAIL~180MG
~N~019471~004~~Jan 23, 1989~No~DISCN~BIOVAIL LABORATORIES INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CARTIA XT~ACTAVIS LABS FL
INC~120MG~A~074752~002~AB3~Jul 9, 1998~No~RX~ACTAVIS LABORATORIES FL INC
CHLORPHENIRAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~CHLORPHENIRAMINE MALEATE
~SANDOZ~12MG~A~070797~001~~Aug 12, 1988~No~DISCN~SANDOZ INC
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEAS
E;ORAL~CODIMAL-L.A. 12~SCHWARZ PHARMA~12MG;120MG~N~018935~001~~Apr 15, 1985~No~D
ISCN~SCHWARZ PHARMA INC
CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE~CAPSULE, EXTENDED RE
LEASE;ORAL~COLD CAPSULE IV~GRAHAM DM~12MG;75MG~N~018793~001~~Apr 25, 1985~No~DIS
CN~DM GRAHAM LABORATORIES INC
CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE~CAPSULE, EXTENDED RE
LEASE;ORAL~COLD CAPSULE V~GRAHAM DM~8MG;75MG~N~018794~001~~Apr 23, 1985~No~DISCN
~DM GRAHAM LABORATORIES INC
PROCHLORPERAZINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~COMPAZINE~GLAXOSMITHKLIN
E~EQ 10MG BASE~N~011000~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKL
INE
E~EQ 10MG BASE~N~021019~001~~Oct 6, 1999~No~DISCN~GLAXOSMITHKLINE
INE
E~EQ 15MG BASE~N~021019~002~~Oct 6, 1999~No~DISCN~GLAXOSMITHKLINE
INE
INE
TRAMADOL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CONZIP~CIPHER PHARMS INC~1
00MG~N~022370~001~~May 7, 2010~Yes~RX~CIPHER PHARMACEUTICALS INC
50MG~N~022370~004~~Aug 1, 2011~No~RX~CIPHER PHARMACEUTICALS INC
00MG~N~022370~002~~May 7, 2010~No~RX~CIPHER PHARMACEUTICALS INC
00MG~N~022370~003~~May 7, 2010~No~RX~CIPHER PHARMACEUTICALS INC
CARVEDILOL PHOSPHATE~CAPSULE, EXTENDED RELEASE;ORAL~COREG CR~SB PHARMCO~10MG~N~0
22012~001~~Oct 20, 2006~No~RX~SB PHARMCO PUERTO RICO INC
22012~003~~Oct 20, 2006~Yes~RX~SB PHARMCO PUERTO RICO INC
CYCLOBENZAPRINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CYCLOBENZAPRINE HYD
ROCHLORIDE~TWI PHARMS INC~15MG~A~091281~001~AB~Jan 31, 2013~No~RX~TWI PHARMACEUT
ICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~CYCLOBENZAPRINE HYD
ROCHLORIDE~TWI PHARMS INC~30MG~A~091281~002~AB~Jan 31, 2013~No~RX~TWI PHARMACEUT
ICALS INC
TOLTERODINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~DETROL LA~PHARMACIA AND UPJO
HN~2MG~N~021228~001~AB~Dec 22, 2000~No~RX~PHARMACIA AND UPJOHN CO
TOLTERODINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~DETROL LA~PHARMACIA AND UPJO
HN~4MG~N~021228~002~AB~Dec 22, 2000~Yes~RX~PHARMACIA AND UPJOHN CO
DEXTROAMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~DEXEDRINE~AMEDRA PHARMS
~5MG~N~017078~001~AB~Approved Prior to Jan 1, 1982~No~RX~AMEDRA PHARMACEUTICALS
LLC
~10MG~N~017078~002~AB~Approved Prior to Jan 1, 1982~No~RX~AMEDRA PHARMACEUTICALS
LLC
~15MG~N~017078~003~AB~Approved Prior to Jan 1, 1982~Yes~RX~AMEDRA PHARMACEUTICAL
S LLC
DEXMETHYLPHENIDATE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DEXMETHYLPHENIDA
TE HYDROCHLORIDE~INTELLIPHARMACEUTICS~15MG~A~078992~003~AB~Nov 18, 2013~No~RX~IN
TELLIPHARMACEUTICS CORP
TE HYDROCHLORIDE~INTELLIPHARMACEUTICS~30MG~A~078992~004~AB~Nov 18, 2013~No~RX~IN
TELLIPHARMACEUTICS CORP
TE HYDROCHLORIDE~MYLAN PHARMS INC~30MG~A~202580~001~AB~Aug 28, 2013~No~RX~MYLAN
PHARMACEUTICALS INC
TE HYDROCHLORIDE~TEVA PHARMS USA~5MG~A~078908~001~AB~Nov 19, 2013~No~RX~TEVA PHA
RMACEUTICALS USA
TE HYDROCHLORIDE~TEVA PHARMS USA~10MG~A~078908~002~AB~Nov 19, 2013~No~RX~TEVA PH
ARMACEUTICALS USA
TE HYDROCHLORIDE~TEVA PHARMS USA~15MG~A~078908~004~AB~May 19, 2014~No~RX~TEVA PH
ARMACEUTICALS USA
ARMACEUTICALS USA
TE HYDROCHLORIDE~TEVA PHARMS USA~30MG~A~202731~003~AB~May 19, 2014~No~RX~TEVA PH
ARMACEUTICALS USA

ARMACEUTICALS USA
TE HYDROCHLORIDE~WATSON LABS INC~15MG~A~079108~003~AB~May 19, 2014~No~RX~WATSON
LABORATORIES INC
TE HYDROCHLORIDE~WATSON LABS INC~30MG~A~079108~005~AB~Nov 21, 2013~No~RX~WATSON
LABORATORIES INC
AMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~DEXTROAMP SACCHARATE, AMP ASP
ARTATE, DEXTROAMP SULFATE AND AMP SULFATE~ACTAVIS ELIZABETH~1.25MG;1.25MG;1.25MG
;1.25MG~A~077302~001~AB~Jun 22, 2012~No~RX~ACTAVIS ELIZABETH LLC
ARTATE, DEXTROAMP SULFATE AND AMP SULFATE~ACTAVIS ELIZABETH~2.5MG;2.5MG;2.5MG;2.
5MG~A~077302~002~AB~Jun 22, 2012~No~RX~ACTAVIS ELIZABETH LLC
ARTATE, DEXTROAMP SULFATE AND AMP SULFATE~ACTAVIS ELIZABETH~5MG;5MG;5MG;5MG~A~07
7302~004~AB~Jun 22, 2012~No~RX~ACTAVIS ELIZABETH LLC
ARTATE, DEXTROAMP SULFATE AND AMP SULFATE~ACTAVIS ELIZABETH~7.5MG;7.5MG;7.5MG;7.
5MG~A~077302~006~AB~Jun 22, 2012~No~RX~ACTAVIS ELIZABETH LLC
AMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~DEXTROAMP SACCHARATE,AMP ASPA
RTATE,DEXTROAMP SULFATE AND AMP SULFATE~BARR LABS INC~1.25MG;1.25MG;1.25MG;1.25M
G~A~076536~001~AB~Feb 12, 2013~No~RX~BARR LABORATORIES INC
RTATE,DEXTROAMP SULFATE AND AMP SULFATE~BARR LABS INC~2.5MG;2.5MG;2.5MG;2.5MG~A~
076536~002~AB~Feb 12, 2013~No~RX~BARR LABORATORIES INC
RTATE,DEXTROAMP SULFATE AND AMP SULFATE~BARR LABS INC~5MG;5MG;5MG;5MG~A~076536~0
04~AB~Feb 12, 2013~No~RX~BARR LABORATORIES INC
RTATE,DEXTROAMP SULFATE AND AMP SULFATE~BARR LABS INC~7.5MG;7.5MG;7.5MG;7.5MG~A~
DEXTROAMPHETAMINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~DEXTROAMPHETAMINE SULFA
TE~ABLE~5MG~A~076814~001~~Aug 25, 2004~No~DISCN~ABLE LABORATORIES INC

TE~ACTAVIS ELIZABETH~5MG~A~203901~001~AB~Nov 30, 2012~No~RX~ACTAVIS ELIZABETH LL
C
TE~ACTAVIS ELIZABETH~10MG~A~203901~002~AB~Nov 30, 2012~No~RX~ACTAVIS ELIZABETH L
LC
TE~ACTAVIS ELIZABETH~15MG~A~203901~003~AB~Nov 30, 2012~No~RX~ACTAVIS ELIZABETH L
LC
TE~BARR~5MG~A~076137~001~AB~Jan 18, 2002~No~RX~BARR LABORATORIES INC
TE~MALLINCKRODT~5MG~A~076353~001~AB~May 6, 2003~No~RX~MALLINCKRODT INC
ACETAZOLAMIDE~CAPSULE, EXTENDED RELEASE;ORAL~DIAMOX~DURAMED PHARMS BARR~500MG~N~
012945~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~DURAMED PHARMACEUTICALS INC S
UB BARR LABORATORIES INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILACOR XR~WATSON LABS~12
0MG~N~020092~001~~May 29, 1992~No~DISCN~WATSON LABORATORIES INC
ISOSORBIDE DINITRATE~CAPSULE, EXTENDED RELEASE;ORAL~DILATRATE-SR~AUXILIUM PHARMS
LLC~40MG~N~019790~001~~Sep 2, 1988~Yes~RX~AUXILIUM PHARMACEUTICALS LLC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILT-CD~APOTEX~120MG~A~07
6151~001~AB3~May 20, 2004~No~RX~APOTEX INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~A
CTAVIS ELIZABETH~360MG~A~202463~001~AB3~Dec 7, 2012~No~RX~ACTAVIS ELIZABETH LLC
CTAVIS LABS FL INC~120MG~A~074852~001~AB2~Oct 10, 1997~No~RX~ACTAVIS LABORATORIE
S FL INC
S FL INC
S FL INC
POTEX~120MG~A~074943~003~AB2~Dec 19, 2000~No~RX~APOTEX INC
POTEX~180MG~A~074943~002~AB2~Dec 19, 2000~No~RX~APOTEX INC
POTEX~240MG~A~074943~001~AB2~Aug 6, 1998~No~RX~APOTEX INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~B

IOVAIL~60MG~A~074845~001~~Sep 15, 1999~No~DISCN~BIOVAIL LABORATORIES INC
IOVAIL~120MG~N~020939~001~~Jan 28, 2000~No~DISCN~BIOVAIL LABORATORIES INC
IOVAIL~360MG~N~020939~005~~Sep 14, 2001~No~DISCN~BIOVAIL LABORATORIES INC
IOVAIL~420MG~N~020939~006~~Sep 14, 2001~No~DISCN~BIOVAIL LABORATORIES INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~M
YLAN~60MG~A~074910~001~~May 2, 1997~No~RX~MYLAN PHARMACEUTICALS INC
YLAN~90MG~A~074910~002~~May 2, 1997~No~RX~MYLAN PHARMACEUTICALS INC
YLAN~120MG~A~074910~003~BC~May 2, 1997~Yes~RX~MYLAN PHARMACEUTICALS INC
YLAN~120MG~A~075124~002~AB2~Mar 18, 1998~No~RX~MYLAN PHARMACEUTICALS INC
YLAN~180MG~A~075124~003~AB2~Mar 18, 1998~No~RX~MYLAN PHARMACEUTICALS INC
YLAN~240MG~A~075124~001~AB2~Mar 18, 1998~Yes~RX~MYLAN PHARMACEUTICALS INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~N
ESHER PHARMS~120MG~A~076563~002~~Sep 12, 2006~No~DISCN~NESHER PHARMACEUTICALS US
A LLC
A LLC
A LLC
A LLC
A LLC
A LLC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~P
AR PHARM~120MG~A~074984~001~AB3~Dec 20, 1999~No~RX~PAR PHARMACEUTICAL INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~S
ANDOZ~120MG~A~091022~001~AB4~Sep 28, 2012~No~RX~SANDOZ INC

UN PHARMA GLOBAL~120MG~A~090421~001~AB4~Nov 15, 2010~No~RX~SUN PHARMA GLOBAL FZE
UN PHARMA GLOBAL~120MG~A~090492~001~AB3~Oct 28, 2011~No~RX~SUN PHARMA GLOBAL FZE
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~T
EVA~60MG~A~074079~001~~Nov 30, 1993~No~DISCN~TEVA PHARMACEUTICALS USA INC
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~V
ALEANT INTL~120MG~A~075116~001~AB3~Dec 23, 1999~No~RX~VALEANT INTERNATIONAL BARB
ADOS SRL
ADOS SRL
ADOS SRL
ADOS SRL
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTZAC~APOTEX INC~120MG~
A~076395~001~AB4~Feb 1, 2006~No~RX~APOTEX INC ETOBICOKE SITE
DISOPYRAMIDE PHOSPHATE~CAPSULE, EXTENDED RELEASE;ORAL~DISOPYRAMIDE PHOSPHATE~NES
HER PHARMS~EQ 150MG BASE~A~071200~001~~Dec 15, 1987~No~DISCN~NESHER PHARMACEUTIC
ALS USA LLC
VENLAFAXINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~EFFEXOR XR~WYETH PHARMS
INC~EQ 37.5MG BASE~N~020699~001~AB~Oct 20, 1997~No~RX~WYETH PHARMACEUTICALS INC

INC~EQ 75MG BASE~N~020699~002~AB~Oct 20, 1997~No~RX~WYETH PHARMACEUTICALS INC
INC~EQ 100MG BASE~N~020699~003~~Oct 20, 1997~No~DISCN~WYETH PHARMACEUTICALS INC
INC~EQ 150MG BASE~N~020699~004~AB~Oct 20, 1997~Yes~RX~WYETH PHARMACEUTICALS INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~ELIXOPHYLLIN SR~FOREST LABS~125MG~A~
086826~001~~Jan 29, 1985~No~DISCN~FOREST LABORATORIES INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~ELIXOPHYLLIN SR~FOREST LABS~250MG~A~
086826~002~~Jan 29, 1985~No~DISCN~FOREST LABORATORIES INC
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~EMBEDA
~ALPHARMA PHARMS~20MG;0.8MG~N~022321~001~~Aug 13, 2009~No~RX~ALPHARMA PHARMACEUT
ICALS LLC
ICALS LLC
~ALPHARMA PHARMS~50MG;2MG~N~022321~003~~Aug 13, 2009~No~RX~ALPHARMA PHARMACEUTIC
ALS LLC
~ALPHARMA PHARMS~60MG;2.4MG~N~022321~004~~Aug 13, 2009~Yes~RX~ALPHARMA PHARMACEU
TICALS LLC
ICALS LLC
~ALPHARMA PHARMS~100MG;4MG~N~022321~006~~Aug 13, 2009~No~RX~ALPHARMA PHARMACEUTI
CALS LLC
CARBAMAZEPINE~CAPSULE, EXTENDED RELEASE;ORAL~EQUETRO~VALIDUS PHARMS INC~100MG~N~
021710~001~~Dec 10, 2004~No~RX~VALIDUS PHARMACEUTICALS INC
021710~002~~Dec 10, 2004~No~RX~VALIDUS PHARMACEUTICALS INC
021710~003~~Dec 10, 2004~Yes~RX~VALIDUS PHARMACEUTICALS INC
LEVOMILNACIPRAN HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~FETZIMA~FOREST LABS
INC~EQ 20MG BASE~N~204168~001~~Jul 25, 2013~No~RX~FOREST LABORATORIES INC
INC~EQ 120MG BASE~N~204168~004~~Jul 25, 2013~Yes~RX~FOREST LABORATORIES INC
FLUVOXAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~FLUVOXAMINE MALEATE~ACTAVIS E
LIZABETH~100MG~A~091482~001~AB~Apr 23, 2013~No~RX~ACTAVIS ELIZABETH LLC
FLUVOXAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~FLUVOXAMINE MALEATE~ACTAVIS E
LIZABETH~150MG~A~091482~002~AB~Nov 18, 2013~No~RX~ACTAVIS ELIZABETH LLC
FLUVOXAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~FLUVOXAMINE MALEATE~ANCHEN PH
ARMS~100MG~A~091476~001~AB~Mar 13, 2013~No~RX~ANCHEN PHARMACEUTICALS INC
FLUVOXAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~FLUVOXAMINE MALEATE~ANCHEN PH
ARMS~150MG~A~091476~002~AB~Mar 13, 2013~No~RX~ANCHEN PHARMACEUTICALS INC
FLUVOXAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~FLUVOXAMINE MALEATE~TORRENT P
HARMS LTD~100MG~A~203240~001~AB~Oct 31, 2014~No~RX~TORRENT PHARMACEUTICALS LTD
FLUVOXAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~FLUVOXAMINE MALEATE~TORRENT P
HARMS LTD~150MG~A~203240~002~AB~Oct 31, 2014~No~RX~TORRENT PHARMACEUTICALS LTD
DEXMETHYLPHENIDATE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~FOCALIN XR~NOVAR
TIS~5MG~N~021802~001~AB~May 26, 2005~No~RX~NOVARTIS PHARMACEUTICALS CORP
TIS~15MG~N~021802~004~AB~Aug 1, 2006~No~RX~NOVARTIS PHARMACEUTICALS CORP

TIS~25MG~N~021802~008~~Apr 21, 2011~No~RX~NOVARTIS PHARMACEUTICALS CORP
TIS~30MG~N~021802~005~AB~Oct 23, 2009~No~RX~NOVARTIS PHARMACEUTICALS CORP
TIS~35MG~N~021802~007~~Apr 21, 2011~No~RX~NOVARTIS PHARMACEUTICALS CORP
TIS~40MG~N~021802~006~AB~Aug 11, 2010~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
GALANTAMINE HYDROBROMIDE~CAPSULE, EXTENDED RELEASE;ORAL~GALANTAMINE HYDROBROMIDE
~BARR~EQ 8MG BASE~A~078189~001~AB~Sep 15, 2008~No~RX~BARR LABORATORIES INC
~IMPAX LABS~EQ 8MG BASE~A~078484~001~AB~May 27, 2009~No~RX~IMPAX LABORATORIES IN
C
~IMPAX LABS~EQ 16MG BASE~A~078484~002~AB~May 27, 2009~No~RX~IMPAX LABORATORIES I
NC
~IMPAX LABS~EQ 24MG BASE~A~078484~003~AB~May 27, 2009~No~RX~IMPAX LABORATORIES I
NC
~MYLAN~EQ 8MG BASE~A~090900~001~AB~Jan 24, 2011~No~RX~MYLAN PHARMACEUTICALS INC
~SUN PHARMA GLOBAL~EQ 8MG BASE~A~090178~001~AB~Feb 2, 2011~No~RX~SUN PHARMA GLOB
AL FZE
~SUN PHARMA GLOBAL~EQ 16MG BASE~A~090178~002~AB~Feb 2, 2011~No~RX~SUN PHARMA GLO
BAL FZE
~SUN PHARMA GLOBAL~EQ 24MG BASE~A~090178~003~AB~Feb 2, 2011~No~RX~SUN PHARMA GLO
BAL FZE
~WATSON LABS~EQ 8MG BASE~A~079028~001~AB~Dec 15, 2008~No~RX~WATSON LABORATORIES
INC
INC
INC
DIPHENYLPYRALINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~HISPRIL~GLAXOSMITH
KLINE~5MG~N~011945~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
PROPRANOLOL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~INDERAL LA~CRANFORD PHA
RMS LLC~60MG~N~018553~004~AB~Mar 18, 1987~No~RX~CRANFORD PHARMACEUTICALS LLC
RMS LLC~80MG~N~018553~002~AB~Apr 19, 1983~No~RX~CRANFORD PHARMACEUTICALS LLC
RMS LLC~120MG~N~018553~003~AB~Apr 19, 1983~No~RX~CRANFORD PHARMACEUTICALS LLC
RMS LLC~160MG~N~018553~001~AB~Apr 19, 1983~Yes~RX~CRANFORD PHARMACEUTICALS LLC
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~IN

DERIDE LA 120/50~WYETH AYERST~50MG;120MG~N~019059~002~~Jul 3, 1985~No~DISCN~WYET
H AYERST LABORATORIES
DERIDE LA 160/50~WYETH AYERST~50MG;160MG~N~019059~003~~Jul 3, 1985~No~DISCN~WYET
DERIDE LA 80/50~WYETH AYERST~50MG;80MG~N~019059~001~~Jul 3, 1985~No~DISCN~WYETH
AYERST LABORATORIES
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOCIN SR~IROKO PHARMS~75MG~N~01818
5~001~~Feb 23, 1982~No~DISCN~IROKO PHARMACEUTICALS LLC
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~ABLE~75MG~A~076114~001~
~Feb 6, 2002~No~DISCN~ABLE LABORATORIES INC
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~AMNEAL PHARMS~75MG~A~09
1549~001~AB~Dec 1, 2010~No~RX~AMNEAL PHARMACEUTICALS
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~AVANTHI INC~75MG~A~0791
75~001~AB~Mar 6, 2009~No~RX~AVANTHI INC
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~HETERO LABS LTD III~75M
G~A~201807~001~AB~Sep 28, 2012~No~RX~HETERO LABS LTD UNIT III
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~INWOOD LABS~75MG~A~0724
10~001~~Mar 15, 1989~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES IN
C
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~MYLAN PHARMS INC~75MG~A
~202139~001~AB~Mar 20, 2014~No~RX~MYLAN PHARMACEUTICALS INC
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~PADDOCK LLC~75MG~A~2005
29~001~AB~Nov 30, 2010~No~RX~PADDOCK LABORATORIES LLC
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~SANDOZ~75MG~A~074464~00
1~AB~May 28, 1998~Yes~RX~SANDOZ INC
INDOMETHACIN~CAPSULE, EXTENDED RELEASE;ORAL~INDOMETHACIN~WATSON LABS INC~75MG~A~
202572~001~AB~Dec 9, 2013~No~RX~WATSON LABORATORIES INC
PROPRANOLOL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~INNOPRAN XL~GLAXOSMITHK
LINE LLC~80MG~N~021438~001~BX~Mar 12, 2003~No~RX~GLAXOSMITHKLINE LLC
PROPRANOLOL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~INNOPRAN XL~GLAXOSMITHK
LINE LLC~120MG~N~021438~002~BX~Mar 12, 2003~No~RX~GLAXOSMITHKLINE LLC
PHENTERMINE RESIN COMPLEX~CAPSULE, EXTENDED RELEASE;ORAL~IONAMIN~UCB INC~EQ 15MG
BASE~N~011613~004~~Approved Prior to Jan 1, 1982~No~DISCN~UCB INC
PHENTERMINE RESIN COMPLEX~CAPSULE, EXTENDED RELEASE;ORAL~IONAMIN~UCB INC~EQ 30MG
BASE~N~011613~002~~Approved Prior to Jan 1, 1982~No~DISCN~UCB INC
E;ORAL~ISOCLOR~FISONS~8MG;120MG~N~018747~001~~Mar 6, 1986~No~DISCN~FISONS CORP
ISOSORBIDE DINITRATE~CAPSULE, EXTENDED RELEASE;ORAL~ISORDIL~WYETH AYERST~40MG~N~
012882~002~~Jul 29, 1988~No~DISCN~WYETH AYERST LABORATORIES
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~K-LEASE~SAVAGE LABS~8MEQ~A~073
398~001~~Jan 28, 1992~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~K-LEASE~SAVAGE LABS~10MEQ~A~07
2427~001~~Mar 28, 1990~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
MORPHINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~KADIAN~WATSON LABS INC~10MG~N~02
0616~008~AB1~Apr 20, 2007~Yes~RX~WATSON LABORATORIES INC
0616~001~AB1~Jul 3, 1996~No~RX~WATSON LABORATORIES INC
0616~004~AB1~Mar 9, 2001~No~RX~WATSON LABORATORIES INC
0616~009~~Jul 9, 2012~No~RX~WATSON LABORATORIES INC
0616~002~AB1~Jul 3, 1996~No~RX~WATSON LABORATORIES INC
0616~005~AB1~Mar 9, 2001~No~RX~WATSON LABORATORIES INC

0616~006~AB1~Oct 27, 2006~No~RX~WATSON LABORATORIES INC
20616~003~AB1~Jul 3, 1996~Yes~RX~WATSON LABORATORIES INC
20616~007~AB1~Feb 27, 2007~Yes~RX~WATSON LABORATORIES INC
KETOPROFEN~CAPSULE, EXTENDED RELEASE;ORAL~KETOPROFEN~ACTAVIS LABS FL INC~100MG~A
~075270~002~AB~Mar 24, 1999~No~RX~ACTAVIS LABORATORIES FL INC
KETOPROFEN~CAPSULE, EXTENDED RELEASE;ORAL~KETOPROFEN~ALKERMES GAINESVILLE~200MG~
A~074879~001~~Dec 10, 1997~No~DISCN~ALKERMES GAINESVILLE LLC
KETOPROFEN~CAPSULE, EXTENDED RELEASE;ORAL~KETOPROFEN~MYLAN~100MG~A~075679~003~AB
~Feb 20, 2002~No~RX~MYLAN PHARMACEUTICALS INC
~Feb 20, 2002~No~RX~MYLAN PHARMACEUTICALS INC
~Feb 20, 2002~Yes~RX~MYLAN PHARMACEUTICALS INC
CHLORDIAZEPOXIDE~CAPSULE, EXTENDED RELEASE;ORAL~LIBRELEASE~VALEANT PHARM INTL~30
MG~N~017813~001~~Sep 12, 1983~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
FLUVOXAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~LUVOX CR~JAZZ PHARMS~100MG~N~
022033~001~AB~Feb 28, 2008~No~RX~JAZZ PHARMACEUTICALS INC
FLUVOXAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~LUVOX CR~JAZZ PHARMS~150MG~N~
022033~002~AB~Feb 28, 2008~Yes~RX~JAZZ PHARMACEUTICALS INC
PHENDIMETRAZINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~MELFIAT-105~NUMARK~105MG
~A~087487~001~~Oct 13, 1982~No~DISCN~NUMARK LABORATORIES INC
MEPROBAMATE~CAPSULE, EXTENDED RELEASE;ORAL~MEPROSPAN~MEDPOINTE PHARM HLC~200MG~N
~011284~001~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS ME
DPOINTE HEALTHCARE INC
MEPROBAMATE~CAPSULE, EXTENDED RELEASE;ORAL~MEPROSPAN~MEDPOINTE PHARM HLC~400MG~N
~011284~002~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS ME
DPOINTE HEALTHCARE INC
METHYLPHENIDATE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~METADATE CD~UCB INC
~10MG~N~021259~003~AB2~May 27, 2003~No~RX~UCB INC
~20MG~N~021259~001~AB2~Apr 3, 2001~No~RX~UCB INC
~30MG~N~021259~002~AB2~Jun 19, 2003~No~RX~UCB INC
~40MG~N~021259~004~AB2~Feb 19, 2006~No~RX~UCB INC
~50MG~N~021259~005~AB2~Feb 19, 2006~No~RX~UCB INC
~60MG~N~021259~006~AB2~Feb 19, 2006~Yes~RX~UCB INC
METHYLPHENIDATE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~METHYLPHENIDATE HYD
ROCHLORIDE~BARR LABS INC~10MG~A~079031~004~AB1~Oct 15, 2014~No~RX~BARR LABORATOR
IES INC
ROCHLORIDE~BARR LABS INC~20MG~A~079031~001~AB1~Jul 13, 2012~No~RX~BARR LABORATOR
IES INC
IES INC

IES INC
ROCHLORIDE~TEVA PHARMS~10MG~A~077707~001~AB2~Jul 19, 2012~No~RX~TEVA PHARMACEUTI
CALS USA
CALS USA
CALS USA
CALS USA
CALS USA
CALS USA
ROCHLORIDE~WATSON LABS INC~20MG~A~078458~001~AB1~Dec 1, 2011~No~RX~WATSON LABORA
TORIES INC
TORIES INC
TORIES INC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~MICRO-K~NESHER PHARMS~8MEQ~N~0
18238~001~AB~Approved Prior to Jan 1, 1982~No~RX~NESHER PHARMACEUTICALS USA LLC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~MICRO-K 10~NESHER PHARMS~10MEQ
~N~018238~002~AB~May 14, 1984~No~RX~NESHER PHARMACEUTICALS USA LLC
MORPHINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~ACTAVIS ELIZABE
TH~30MG~A~079040~001~AB2~Jan 16, 2013~No~RX~ACTAVIS ELIZABETH LLC
MORPHINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~PAR PHARM INC~2
0MG~A~200812~001~AB1~Nov 10, 2011~No~RX~PAR PHARMACEUTICAL INC
MORPHINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~TEVA PHARMS USA
~20MG~A~202718~001~AB1~Dec 29, 2014~No~RX~TEVA PHARMACEUTICALS USA

MORPHINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~UPSHER SMITH~10
MG~A~202104~001~AB1~Jun 3, 2013~No~RX~UPSHER SMITH LABORATORIES INC
0MG~A~202104~007~AB1~Jun 3, 2013~No~RX~UPSHER SMITH LABORATORIES INC
MEMANTINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~NAMENDA XR~FOREST LABS~7M
G~N~022525~001~~Jun 21, 2010~No~RX~FOREST LABORATORIES INC
MEMANTINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~NAMENDA XR~FOREST LABS~14
MG~N~022525~002~~Jun 21, 2010~No~RX~FOREST LABORATORIES INC
MG~N~022525~003~~Jun 21, 2010~No~RX~FOREST LABORATORIES INC
MG~N~022525~004~~Jun 21, 2010~Yes~RX~FOREST LABORATORIES INC
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~
NAMZARIC~FOREST LABS INC~10MG;14MG~N~206439~001~~Dec 23, 2014~No~RX~FOREST LABOR
ATORIES INC
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~
NAMZARIC~FOREST LABS INC~10MG;28MG~N~206439~002~~Dec 23, 2014~Yes~RX~FOREST LABO
RATORIES INC
DISOPYRAMIDE PHOSPHATE~CAPSULE, EXTENDED RELEASE;ORAL~NORPACE CR~GD SEARLE LLC~E
Q 100MG BASE~N~018655~001~~Jul 20, 1982~No~RX~GD SEARLE LLC
DISOPYRAMIDE PHOSPHATE~CAPSULE, EXTENDED RELEASE;ORAL~NORPACE CR~GD SEARLE LLC~E
Q 150MG BASE~N~018655~002~AB~Jul 20, 1982~Yes~RX~GD SEARLE LLC
PSEUDOEPHEDRINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~NOVAFED~SANOFI AVEN
TIS US~120MG~N~017603~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS
US LLC
KETOPROFEN~CAPSULE, EXTENDED RELEASE;ORAL~ORUVAIL~WYETH PHARMS INC~100MG~N~01981
6~003~~Feb 8, 1995~No~DISCN~WYETH PHARMACEUTICALS INC
6~002~~Feb 8, 1995~No~DISCN~WYETH PHARMACEUTICALS INC
6~001~~Sep 24, 1993~No~DISCN~WYETH PHARMACEUTICALS INC
HYDROMORPHONE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~PALLADONE~PURDUE PHAR
MA LP~12MG~N~021044~001~~Sep 24, 2004~No~DISCN~PURDUE PHARMA LP
MESALAMINE~CAPSULE, EXTENDED RELEASE;ORAL~PENTASA~SHIRE~250MG~N~020049~001~~May
10, 1993~No~RX~SHIRE DEVELOPMENT INC
MESALAMINE~CAPSULE, EXTENDED RELEASE;ORAL~PENTASA~SHIRE~500MG~N~020049~002~~Jul

8, 2004~Yes~RX~SHIRE DEVELOPMENT INC
PHENDIMETRAZINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~PHENDIMETRAZINE TARTRATE
~GRAHAM DM~105MG~A~087214~001~~May 26, 1982~No~DISCN~DM GRAHAM LABORATORIES INC
~GRAHAM DM~105MG~A~088020~001~~Aug 16, 1982~No~DISCN~DM GRAHAM LABORATORIES INC
~GRAHAM DM~105MG~A~088028~001~~Aug 16, 1982~No~DISCN~DM GRAHAM LABORATORIES INC
~GRAHAM DM~105MG~A~088062~001~~Sep 13, 1982~No~DISCN~DM GRAHAM LABORATORIES INC
~GRAHAM DM~105MG~A~088063~001~~Sep 10, 1982~No~DISCN~DM GRAHAM LABORATORIES INC
~GRAHAM DM~105MG~A~088111~001~~Oct 18, 1982~No~DISCN~DM GRAHAM LABORATORIES INC
~SANDOZ~105MG~A~087378~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
~SANDOZ~105MG~N~018074~001~~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
PHENTERMINE RESIN COMPLEX~CAPSULE, EXTENDED RELEASE;ORAL~PHENTERMINE RESIN 30~QU
ANTUM PHARMICS~EQ 30MG BASE~A~089120~001~~Feb 4, 1988~No~DISCN~QUANTUM PHARMICS
LTD
PHENTERMINE RESIN COMPLEX~CAPSULE, EXTENDED RELEASE;ORAL~PHENTERMINE RESIN COMPL
EX~LANNETT HOLDINGS INC~EQ 15MG BASE~A~040872~001~~Jul 28, 2011~Yes~RX~LANNETT H
OLDINGS INC
PHENTERMINE RESIN COMPLEX~CAPSULE, EXTENDED RELEASE;ORAL~PHENTERMINE RESIN COMPL
EX~LANNETT HOLDINGS INC~EQ 30MG BASE~A~040872~002~~Jul 28, 2011~Yes~RX~LANNETT H
OLDINGS INC
PINACIDIL~CAPSULE, EXTENDED RELEASE;ORAL~PINDAC~LEO PHARM~12.5MG~N~019456~001~~D
ec 28, 1989~No~DISCN~LEO PHARMACEUTICAL PRODUCTS LTD
PINACIDIL~CAPSULE, EXTENDED RELEASE;ORAL~PINDAC~LEO PHARM~25MG~N~019456~002~~Dec
28, 1989~No~DISCN~LEO PHARMACEUTICAL PRODUCTS LTD
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~ACTAVIS LAB
S FL INC~8MEQ~A~077419~001~AB~Jun 2, 2008~No~RX~ACTAVIS LABORATORIES FL INC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~ACTAVIS LAB
S FL INC~10MEQ~A~077419~002~AB~Jun 2, 2008~Yes~RX~ACTAVIS LABORATORIES FL INC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~AMNEAL PHAR
MS~10MEQ~A~202128~001~AB~Feb 22, 2013~No~RX~AMNEAL PHARMACEUTICALS
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~ANCHEN PHAR
MS~8MEQ~A~202886~001~AB~Dec 26, 2013~No~RX~ANCHEN PHARMACEUTICALS INC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~ANCHEN PHAR
MS~10MEQ~A~202886~002~AB~Dec 26, 2013~No~RX~ANCHEN PHARMACEUTICALS INC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~NESHER PHAR
MS~10MEQ~A~070980~001~~Feb 17, 1987~No~DISCN~NESHER PHARMACEUTICALS USA LLC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~PADDOCK LLC
~8MEQ~A~200185~001~AB~May 18, 2011~No~RX~PADDOCK LABORATORIES LLC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~PADDOCK LLC
~10MEQ~A~200185~002~AB~May 18, 2011~No~RX~PADDOCK LABORATORIES LLC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~TEVA~8MEQ~A
~073531~001~~Apr 26, 1996~No~DISCN~TEVA PHARMACEUTICALS USA INC
POTASSIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~TEVA~10MEQ~
A~073532~001~~Apr 26, 1996~No~DISCN~TEVA PHARMACEUTICALS USA INC
PROPAFENONE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~PROPAFENONE HYDROCHLORI
DE~PAR PHARM~225MG~A~078540~001~AB~Oct 18, 2010~No~RX~PAR PHARMACEUTICAL
PROPRANOLOL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~PROPRANOLOL HYDROCHLORI
DE~ACTAVIS ELIZABETH~60MG~A~078494~001~AB~Aug 10, 2007~No~RX~ACTAVIS ELIZABETH L
LC

DE~ACTAVIS ELIZABETH~80MG~A~078494~002~AB~Aug 10, 2007~No~RX~ACTAVIS ELIZABETH L
LC
DE~ACTAVIS ELIZABETH~120MG~A~078494~003~AB~Aug 10, 2007~No~RX~ACTAVIS ELIZABETH
LLC
DE~ACTAVIS ELIZABETH~160MG~A~078494~004~AB~Aug 10, 2007~No~RX~ACTAVIS ELIZABETH
LLC
DE~APTALIS PHARMATECH~60MG~A~078703~001~AB~Jul 15, 2011~No~RX~APTALIS PHARMATECH
INC
DE~APTALIS PHARMATECH~80MG~A~078703~002~AB~Jul 15, 2011~No~RX~APTALIS PHARMATECH
INC
DE~APTALIS PHARMATECH~120MG~A~078703~003~AB~Jul 15, 2011~No~RX~APTALIS PHARMATEC
H INC
DE~APTALIS PHARMATECH~160MG~A~078703~004~AB~Jul 15, 2011~No~RX~APTALIS PHARMATEC
H INC
DE~INWOOD LABS~60MG~A~072499~001~~Apr 11, 1989~No~DISCN~INWOOD LABORATORIES INC
SUB FOREST LABORATORIES INC
DE~MYLAN~60MG~A~078022~001~AB~Feb 15, 2007~No~RX~MYLAN PHARMACEUTICALS INC
DE~NORTEC DEV ASSOC~60MG~A~078065~001~AB~Jan 26, 2007~No~RX~NORTEC DEVELOPMENT A
SSOC INC
DE~NORTEC DEV ASSOC~80MG~A~078065~002~AB~Jan 26, 2007~No~RX~NORTEC DEVELOPMENT A
SSOC INC
DE~NORTEC DEV ASSOC~120MG~A~078065~003~AB~Jan 26, 2007~No~RX~NORTEC DEVELOPMENT
ASSOC INC
DE~NORTEC DEV ASSOC~160MG~A~078065~004~AB~Jan 26, 2007~No~RX~NORTEC DEVELOPMENT
ASSOC INC
DE~UPSHER SMITH~60MG~A~078311~001~AB~Mar 6, 2009~No~RX~UPSHER SMITH LABORATORIES
INC
DE~UPSHER SMITH~80MG~A~078311~002~AB~Mar 6, 2009~No~RX~UPSHER SMITH LABORATORIES
INC
DE~UPSHER SMITH~120MG~A~078311~003~AB~Mar 6, 2009~No~RX~UPSHER SMITH LABORATORIE

S INC
DE~UPSHER SMITH~160MG~A~078311~004~AB~Mar 6, 2009~No~RX~UPSHER SMITH LABORATORIE
S INC
DE~ZYDUS PHARMS USA INC~60MG~A~090321~001~AB~Mar 25, 2011~No~RX~ZYDUS PHARMACEUT
ICALS USA INC
DE~ZYDUS PHARMS USA INC~80MG~A~090321~002~AB~Mar 25, 2011~No~RX~ZYDUS PHARMACEUT
ICALS USA INC
DE~ZYDUS PHARMS USA INC~120MG~A~090321~003~AB~Mar 25, 2011~No~RX~ZYDUS PHARMACEU
TICALS USA INC
DE~ZYDUS PHARMS USA INC~160MG~A~090321~004~AB~Mar 25, 2011~No~RX~ZYDUS PHARMACEU
TICALS USA INC
E;ORAL~PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE~CENT PHARMS~8M
G;120MG~N~019428~001~~Aug 2, 1988~No~DISCN~CENTRAL PHARMACEUTICALS INC
E;ORAL~PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE~GRAHAM DM~8MG;
120MG~N~018844~001~~Mar 20, 1985~No~DISCN~DM GRAHAM LABORATORIES INC
E;ORAL~PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE~GRAHAM DM~12MG
;120MG~N~018843~001~~Mar 18, 1985~No~DISCN~DM GRAHAM LABORATORIES INC
E;ORAL~PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE~KV PHARM~12MG;
120MG~A~071455~001~~Mar 1, 1989~No~DISCN~KV PHARMACEUTICAL CO
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE~CAPSULE, EXTENDED RELEASE;ORAL~QSYMIA~VIVU
S~EQ 3.75MG BASE;23MG~N~022580~001~~Jul 17, 2012~No~RX~VIVUS INC
S~EQ 15MG BASE;92MG~N~022580~004~~Jul 17, 2012~Yes~RX~VIVUS INC
TOPIRAMATE~CAPSULE, EXTENDED RELEASE;ORAL~QUDEXY XR~UPSHER SMITH~25MG~N~205122~0
01~~Mar 11, 2014~No~RX~UPSHER SMITH LABORATORIES INC
TOPIRAMATE~CAPSULE, EXTENDED RELEASE;ORAL~QUDEXY XR~UPSHER SMITH~50MG~N~205122~0
TOPIRAMATE~CAPSULE, EXTENDED RELEASE;ORAL~QUDEXY XR~UPSHER SMITH~100MG~N~205122~
005~~Mar 11, 2014~Yes~RX~UPSHER SMITH LABORATORIES INC
GALANTAMINE HYDROBROMIDE~CAPSULE, EXTENDED RELEASE;ORAL~RAZADYNE ER~JANSSEN PHAR
MS~EQ 8MG BASE~N~021615~001~AB~Apr 1, 2005~Yes~RX~JANSSEN PHARMACEUTICALS INC
MS~EQ 16MG BASE~N~021615~002~AB~Apr 1, 2005~No~RX~JANSSEN PHARMACEUTICALS INC
MS~EQ 24MG BASE~N~021615~003~AB~Apr 1, 2005~No~RX~JANSSEN PHARMACEUTICALS INC
METHYLPHENIDATE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~RITALIN LA~NOVARTIS
~10MG~N~021284~004~AB1~Apr 10, 2004~No~RX~NOVARTIS PHARMACEUTICALS CORP
~20MG~N~021284~001~AB1~Jun 5, 2002~No~RX~NOVARTIS PHARMACEUTICALS CORP

~60MG~N~021284~005~~Oct 27, 2014~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
CARBIDOPA; LEVODOPA~CAPSULE, EXTENDED RELEASE;ORAL~RYTARY~IMPAX LABS INC~23.75MG
;95MG~N~203312~001~~Jan 7, 2015~No~RX~IMPAX LABORATORIES INC
;245MG~N~203312~004~~Jan 7, 2015~Yes~RX~IMPAX LABORATORIES INC
PROPAFENONE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~RYTHMOL SR~GLAXOSMITHKL
INE LLC~225MG~N~021416~001~AB~Sep 4, 2003~No~RX~GLAXOSMITHKLINE LLC
INE LLC~325MG~N~021416~002~AB~Sep 4, 2003~No~RX~GLAXOSMITHKLINE LLC
INE LLC~425MG~N~021416~003~AB~Sep 4, 2003~Yes~RX~GLAXOSMITHKLINE LLC
TROSPIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~SANCTURA XR~ALLERGAN~60MG~N~022
103~001~AB~Aug 3, 2007~Yes~RX~ALLERGAN INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~SLO-BID~SANOFI AVENTIS US~50MG~A~088
269~001~~Jan 31, 1985~No~DISCN~SANOFI AVENTIS US LLC
539~001~~May 10, 1989~No~DISCN~SANOFI AVENTIS US LLC
9540~001~~May 10, 1989~No~DISCN~SANOFI AVENTIS US LLC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~SLO-PHYLLIN~SANOFI AVENTIS US~60MG~A
~085206~001~~May 24, 1982~No~DISCN~SANOFI AVENTIS US LLC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~SLO-PHYLLIN~SANOFI AVENTIS US~125MG~
A~085203~001~~May 24, 1982~No~DISCN~SANOFI AVENTIS US LLC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~SLO-PHYLLIN~SANOFI AVENTIS US~250MG~
A~085205~001~~May 24, 1982~No~DISCN~SANOFI AVENTIS US LLC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~SOMOPHYLLIN-CRT~GRAHAM DM~50MG~A~087
763~001~~Feb 27, 1985~No~DISCN~DM GRAHAM LABORATORIES INC
7194~001~~Approved Prior to Jan 1, 1982~No~DISCN~DM GRAHAM LABORATORIES INC
7193~001~~Approved Prior to Jan 1, 1982~No~DISCN~DM GRAHAM LABORATORIES INC
PHENDIMETRAZINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~SPRX-105~NUMARK~105MG~A~
088024~001~~Dec 22, 1982~No~DISCN~NUMARK LABORATORIES INC
PSEUDOEPHEDRINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~SUDAFED 12 HOUR~GLA
XOSMITHKLINE~120MG **Federal Register determination that product was not discont
inued or withdrawn for safety or efficacy reasons**~N~017941~002~~Approved Prior
to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~TAZTIA XT~ACTAVIS LABS FL
INC~120MG~A~075401~001~AB4~Apr 10, 2003~No~RX~ACTAVIS LABORATORIES FL INC

CHLORPHENIRAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~TELDRIN~GLAXOSMITHKLINE~
8MG~N~017369~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CHLORPHENIRAMINE MALEATE~CAPSULE, EXTENDED RELEASE;ORAL~TELDRIN~GLAXOSMITHKLINE~
12MG~N~017369~002~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
TRIMEPRAZINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~TEMARIL~ALLERGAN HERBERT~EQ
5MG BASE~N~011316~004~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN HERBERT
SKIN CARE DIV ALLERGAN INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEO-24~ACTIENT PHARMS~100MG~A~08794
2~001~~Aug 22, 1983~No~RX~ACTIENT PHARMACEUTICALS LLC
4~001~~Feb 28, 1992~Yes~RX~ACTIENT PHARMACEUTICALS LLC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEO-DUR~SCHERING~50MG~A~088022~001~
~Sep 10, 1985~No~DISCN~SCHERING CORP
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEO-DUR~SCHERING~75MG~A~088015~001~
~Sep 10, 1985~No~DISCN~SCHERING CORP
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEO-DUR~SCHERING~125MG~A~088016~001
~~Sep 10, 1985~No~DISCN~SCHERING CORP
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEO-DUR~SCHERING~200MG~A~087995~001
~~Sep 10, 1985~No~DISCN~SCHERING CORP
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOBID~WHITBY~260MG~A~085983~001~~M
ar 20, 1985~No~DISCN~WHITBY PHARMACEUTICALS INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOBID JR.~WHITBY~130MG~A~087854~00
1~~Mar 20, 1985~No~DISCN~WHITBY PHARMACEUTICALS INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOCLEAR L.A.-130~SCHWARZ PHARMA~13
0MG~A~086569~001~~May 27, 1982~No~DISCN~SCHWARZ PHARMA INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOCLEAR L.A.-260~SCHWARZ PHARMA~26
0MG~A~086569~002~~May 27, 1982~No~DISCN~SCHWARZ PHARMA INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYL-SR~ORTHO MCNEIL PHARM~125MG
~A~086480~001~~Feb 8, 1985~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYL-SR~ORTHO MCNEIL PHARM~250MG
~A~086471~001~~Feb 8, 1985~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYLLINE~CENT PHARMS~125MG~A~088
654~001~~Feb 12, 1985~No~DISCN~CENTRAL PHARMACEUTICALS INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYLLINE~CENT PHARMS~250MG~A~088
689~001~~Feb 12, 1985~No~DISCN~CENTRAL PHARMACEUTICALS INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYLLINE~HOSPIRA~100MG~A~089976~
001~~Jan 4, 1995~No~DISCN~HOSPIRA INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYLLINE~INWOOD LABS~100MG~A~040
052~001~~Feb 14, 1994~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES I
NC
NC
NC
NC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYLLINE~SANDOZ~260MG~A~087462~0

01~~May 11, 1982~No~DISCN~SANDOZ INC
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYLLINE-SR~SCHERER RP~300MG~A~0
88255~001~~Jun 12, 1986~No~DISCN~RP SCHERER NORTH AMERICA DIV RP SCHERER CORP
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOVENT~SCHERING~125MG~A~087010~001
~~Jan 31, 1985~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOVENT~SCHERING~250MG~A~087910~001
~~Jan 31, 1985~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
CHLORPROMAZINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~THORAZINE~GLAXOSMITH
DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~TIAZAC~VALEANT PHARMS NOR
TH~120MG~N~020401~001~AB4~Sep 11, 1995~No~RX~VALEANT PHARMACEUTICALS NORTH AMERI
CA LLC
CA LLC
CA LLC
CA LLC
CA LLC
TH~420MG~N~020401~006~AB4~Oct 16, 1998~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMER
ICA LLC
TOLTERODINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~TOLTERODINE TARTRATE~MYLAN P
HARMS INC~2MG~A~201486~001~AB~Oct 31, 2013~No~RX~MYLAN PHARMACEUTICALS INC
TOLTERODINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~TOLTERODINE TARTRATE~MYLAN P
HARMS INC~4MG~A~201486~002~AB~Oct 31, 2013~No~RX~MYLAN PHARMACEUTICALS INC
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~CAPSULE, EXTENDED RELE
ASE;ORAL~TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES~KV PHARM~120MG;5MG~A~07
1798~001~~Mar 16, 1989~No~DISCN~KV PHARMACEUTICAL CO
TOPIRAMATE~CAPSULE, EXTENDED RELEASE;ORAL~TROKENDI XR~SUPERNUS PHARMS~25MG~N~201
635~001~~Aug 16, 2013~No~RX~SUPERNUS PHARMACEUTICALS INC
1635~004~~Aug 16, 2013~Yes~RX~SUPERNUS PHARMACEUTICALS INC
TROSPIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~TROSPIUM CHLORIDE~ACTAVIS LABS
FL INC~60MG~A~091289~001~AB~Oct 12, 2012~No~RX~ACTAVIS LABORATORIES FL INC
TROSPIUM CHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~TROSPIUM CHLORIDE~PADDOCK LLC~6
0MG~A~201291~001~AB~May 24, 2013~No~RX~PADDOCK LABORATORIES LLC
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX~CAPSULE, EXTENDED RELEASE;OR
AL~TUSSICAPS~ECR PHARMA~EQ 4MG MALEATE;EQ 5MG BITARTRATE~A~077273~002~~Sep 24, 2
007~No~RX~ECR PHARMA
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX~CAPSULE, EXTENDED RELEASE;OR
AL~TUSSICAPS~ECR PHARMA~EQ 8MG MALEATE;EQ 10MG BITARTRATE~A~077273~001~~Sep 24,
2007~Yes~RX~ECR PHARMA
DIAZEPAM~CAPSULE, EXTENDED RELEASE;ORAL~VALRELEASE~ROCHE~15MG~N~018179~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
VENLAFAXINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~VENLAFAXINE HYDROCHLORI
DE~ANCHEN PHARMS~EQ 37.5MG BASE~A~078087~001~AB~Mar 16, 2012~No~RX~ANCHEN PHARMA
CEUTICALS, INC
DE~ANCHEN PHARMS~EQ 75MG BASE~A~078087~002~AB~Mar 16, 2012~No~RX~ANCHEN PHARMACE
UTICALS, INC
DE~ANCHEN PHARMS~EQ 150MG BASE~A~078087~003~AB~Mar 16, 2012~No~RX~ANCHEN PHARMAC
EUTICALS, INC
DE~AUROBINDO PHARMA LTD~EQ 37.5MG BASE~A~200834~001~AB~Apr 14, 2011~No~RX~AUROBI
NDO PHARMA LIMITED
DE~AUROBINDO PHARMA LTD~EQ 75MG BASE~A~200834~002~AB~Apr 14, 2011~No~RX~AUROBIND
O PHARMA LIMITED
DE~AUROBINDO PHARMA LTD~EQ 150MG BASE~A~200834~003~AB~Apr 14, 2011~No~RX~AUROBIN
DO PHARMA LIMITED
DE~DR REDDYS LABS LTD~EQ 37.5MG BASE~A~078421~001~AB~May 6, 2011~No~RX~DR REDDYS
LABORATORIES LTD
DE~DR REDDYS LABS LTD~EQ 75MG BASE~A~078421~002~AB~May 6, 2011~No~RX~DR REDDYS L
ABORATORIES LTD
DE~DR REDDYS LABS LTD~EQ 150MG BASE~A~078421~003~AB~May 6, 2011~No~RX~DR REDDYS
LABORATORIES LTD
DE~MYLAN~EQ 37.5MG BASE~A~078789~001~AB~Jun 1, 2011~No~RX~MYLAN PHARMACEUTICALS
INC
DE~MYLAN~EQ 75MG BASE~A~078789~002~AB~Jun 1, 2011~No~RX~MYLAN PHARMACEUTICALS IN
C
DE~MYLAN~EQ 150MG BASE~A~078789~003~AB~Jun 1, 2011~No~RX~MYLAN PHARMACEUTICALS I
NC
DE~ORCHID HLTHCARE~EQ 37.5MG BASE~A~091123~001~AB~Jul 11, 2011~No~RX~ORCHID HEAL
THCARE
DE~ORCHID HLTHCARE~EQ 75MG BASE~A~091123~002~AB~Jul 11, 2011~No~RX~ORCHID HEALTH
CARE
DE~ORCHID HLTHCARE~EQ 150MG BASE~A~091123~003~AB~Jul 11, 2011~No~RX~ORCHID HEALT
HCARE
DE~TEVA~EQ 37.5MG BASE~A~076565~001~AB~Jun 28, 2010~No~RX~TEVA PHARMACEUTICALS U
SA INC
DE~TEVA~EQ 75MG BASE~A~076565~002~AB~Jun 28, 2010~No~RX~TEVA PHARMACEUTICALS USA
INC
DE~TEVA~EQ 150MG BASE~A~076565~003~AB~Jun 28, 2010~No~RX~TEVA PHARMACEUTICALS US
A INC
DE~TORRENT PHARMS LLC~EQ 37.5MG BASE~A~090899~001~AB~Jun 1, 2011~No~RX~TORRENT P
HARMACEUTICALS LLC

DE~TORRENT PHARMS LLC~EQ 75MG BASE~A~090899~002~AB~Jun 1, 2011~No~RX~TORRENT PHA
RMACEUTICALS LLC
DE~TORRENT PHARMS LLC~EQ 150MG BASE~A~090899~003~AB~Jun 1, 2011~No~RX~TORRENT PH
ARMACEUTICALS LLC
DE~VALEANT PHARMS NORTH~EQ 37.5MG BASE~A~090071~001~AB~Apr 15, 2011~No~RX~VALEAN
T PHARMACEUTICALS NORTH AMERICA LLC
DE~VALEANT PHARMS NORTH~EQ 75MG BASE~A~090071~002~AB~Apr 15, 2011~No~RX~VALEANT
PHARMACEUTICALS NORTH AMERICA LLC
DE~VALEANT PHARMS NORTH~EQ 150MG BASE~A~090071~003~AB~Apr 15, 2011~No~RX~VALEANT
PHARMACEUTICALS NORTH AMERICA LLC
DE~WOCKHARDT~EQ 37.5MG BASE~A~078865~001~AB~Apr 14, 2011~No~RX~WOCKHARDT LTD
DE~WOCKHARDT~EQ 75MG BASE~A~078865~002~AB~Apr 14, 2011~No~RX~WOCKHARDT LTD
DE~WOCKHARDT~EQ 150MG BASE~A~078865~003~AB~Apr 14, 2011~No~RX~WOCKHARDT LTD
DE~ZYDUS PHARMS USA INC~EQ 37.5MG BASE~A~090174~001~AB~Apr 14, 2011~No~RX~ZYDUS
PHARMACEUTICALS USA INC
DE~ZYDUS PHARMS USA INC~EQ 75MG BASE~A~090174~002~AB~Apr 14, 2011~No~RX~ZYDUS PH
DE~ZYDUS PHARMS USA INC~EQ 150MG BASE~A~090174~003~AB~Apr 14, 2011~No~RX~ZYDUS P
HARMACEUTICALS USA INC
VERAPAMIL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~M
YLAN~100MG~A~078306~001~AB~Aug 9, 2007~No~RX~MYLAN PHARMACEUTICALS INC
YLAN~120MG~A~075138~001~AB~Apr 20, 1999~No~RX~MYLAN PHARMACEUTICALS INC
VERAPAMIL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~VERELAN~ALKERMES GAINESVI
LLE~120MG~N~019614~001~AB~May 29, 1990~No~RX~ALKERMES GAINESVILLE LLC
LLE~180MG~N~019614~003~AB~Jan 9, 1992~No~RX~ALKERMES GAINESVILLE LLC
LLE~240MG~N~019614~002~AB~May 29, 1990~No~RX~ALKERMES GAINESVILLE LLC
LLE~360MG~N~019614~004~~May 10, 1996~Yes~RX~ALKERMES GAINESVILLE LLC
VERAPAMIL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~VERELAN PM~ALKERMES GAINE
SVILLE~100MG~N~020943~001~AB~Nov 25, 1998~No~RX~ALKERMES GAINESVILLE LLC
SVILLE~200MG~N~020943~002~AB~Nov 25, 1998~No~RX~ALKERMES GAINESVILLE LLC
SVILLE~300MG~N~020943~003~AB~Nov 25, 1998~Yes~RX~ALKERMES GAINESVILLE LLC
PHENDIMETRAZINE TARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~X-TROZINE L.A.~SHIRE RIC
HWOOD~105MG~A~087371~001~~Aug 24, 1982~No~DISCN~SHIRE RICHWOOD INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~XIMINO~RANBAXY LABS LTD
~EQ 45MG BASE~N~201922~001~~Jul 11, 2012~No~DISCN~RANBAXY LABORATORIES LTD

~EQ 67.5MG BASE~N~201922~002~~Jul 11, 2012~No~DISCN~RANBAXY LABORATORIES LTD
~EQ 112.5MG BASE~N~201922~004~~Jul 11, 2012~No~DISCN~RANBAXY LABORATORIES LTD
STAVUDINE~CAPSULE, EXTENDED RELEASE;ORAL~ZERIT XR~BRISTOL MYERS SQUIBB~37.5MG~N~
021453~001~~Dec 31, 2002~No~DISCN~BRISTOL MYERS SQUIBB CO
STAVUDINE~CAPSULE, EXTENDED RELEASE;ORAL~ZERIT XR~BRISTOL MYERS SQUIBB~50MG~N~02
HYDROCODONE BITARTRATE~CAPSULE, EXTENDED RELEASE;ORAL~ZOHYDRO ER~ZOGENIX INC~10M
G ~N~202880~001~~Oct 25, 2013~Yes~RX~ZOGENIX INC
G ~N~202880~002~~Oct 25, 2013~No~RX~ZOGENIX INC
G~N~202880~003~~Oct 25, 2013~No~RX~ZOGENIX INC
G~N~202880~005~~Oct 25, 2013~No~RX~ZOGENIX INC
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE~CAPSULE, TABLET, CAPSULE, DELAYED RELEAS
E;ORAL~OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN~GASTROENTERO~500MG,N/A,N/A;
N/A,500MG,N/A;N/A,N/A,20MG~N~050824~001~~Feb 8, 2011~Yes~RX~GASTROENTERO LOGIC L
LC
CROMOLYN SODIUM~CAPSULE;INHALATION~INTAL~SANOFI AVENTIS US~20MG **Federal Regist
er determination that product was not discontinued or withdrawn for safety or ef
ficacy reasons**~N~016990~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVE
NTIS US LLC
ALBUTEROL SULFATE~CAPSULE;INHALATION~VENTOLIN ROTACAPS~GLAXOSMITHKLINE~EQ 0.2MG
BASE~N~019489~001~~May 4, 1988~No~DISCN~GLAXOSMITHKLINE
METHOXSALEN~CAPSULE;ORAL~8-MOP~VALEANT PHARM INTL~10MG~N~009048~001~~Approved Pr
ior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~A-POXIDE~ABBOTT~5MG~A~085447~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS
DIV
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~A-POXIDE~ABBOTT~5MG~A~085517~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS
DIV
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~A-POXIDE~ABBOTT~10MG~A~085447~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCT
S DIV
S DIV
S DIV
S DIV
ISOTRETINOIN~CAPSULE;ORAL~ABSORICA~RANBAXY~10MG~N~021951~001~BX~May 25, 2012~No~
RX~RANBAXY INC

RX~RANBAXY INC
ISOTRETINOIN~CAPSULE;ORAL~ABSORICA~RANBAXY~25MG~N~021951~005~~Aug 15, 2014~No~RX
~RANBAXY INC
RX~RANBAXY INC
ISOTRETINOIN~CAPSULE;ORAL~ABSORICA~RANBAXY~35MG~N~021951~006~~Aug 15, 2014~No~RX
~RANBAXY INC
ISOTRETINOIN~CAPSULE;ORAL~ABSORICA~RANBAXY~40MG~N~021951~004~BX~May 25, 2012~Yes
~RX~RANBAXY INC
ISOTRETINOIN~CAPSULE;ORAL~ACCUTANE~HOFFMANN LA ROCHE~10MG~N~018662~002~~May 7, 1
982~No~DISCN~HOFFMANN LA ROCHE INC
ISOTRETINOIN~CAPSULE;ORAL~ACCUTANE~HOFFMANN LA ROCHE~20MG~N~018662~004~~Mar 28,
ISOTRETINOIN~CAPSULE;ORAL~ACCUTANE~HOFFMANN LA ROCHE~40MG~N~018662~003~~May 7, 1
ACEBUTOLOL HYDROCHLORIDE~CAPSULE;ORAL~ACEBUTOLOL HYDROCHLORIDE~AMNEAL PHARM~EQ 2
00MG BASE~A~075047~001~AB~Dec 30, 1999~No~RX~AMNEAL PHARMACEUTICAL
ACEBUTOLOL HYDROCHLORIDE~CAPSULE;ORAL~ACEBUTOLOL HYDROCHLORIDE~AMNEAL PHARM~EQ 4
00MG BASE~A~075047~002~AB~Dec 30, 1999~No~RX~AMNEAL PHARMACEUTICAL
ACEBUTOLOL HYDROCHLORIDE~CAPSULE;ORAL~ACEBUTOLOL HYDROCHLORIDE~MYLAN~EQ 200MG BA
SE~A~074288~001~AB~Apr 24, 1995~No~RX~MYLAN PHARMACEUTICALS INC
ACEBUTOLOL HYDROCHLORIDE~CAPSULE;ORAL~ACEBUTOLOL HYDROCHLORIDE~MYLAN~EQ 400MG BA
SE~A~074288~002~AB~Apr 24, 1995~No~RX~MYLAN PHARMACEUTICALS INC
ACEBUTOLOL HYDROCHLORIDE~CAPSULE;ORAL~ACEBUTOLOL HYDROCHLORIDE~WATSON LABS~EQ 20
0MG BASE~A~074007~001~~Oct 18, 1995~No~DISCN~WATSON LABORATORIES INC
ACEBUTOLOL HYDROCHLORIDE~CAPSULE;ORAL~ACEBUTOLOL HYDROCHLORIDE~WATSON LABS~EQ 40
0MG BASE~A~074007~002~~Oct 18, 1995~No~DISCN~WATSON LABORATORIES INC
ACETAMINOPHEN; CODEINE PHOSPHATE~CAPSULE;ORAL~ACETAMINOPHEN AND CODEINE PHOSPHAT
E~TEVA~300MG;15MG~A~088537~001~~Jun 4, 1984~No~DISCN~TEVA PHARMACEUTICALS USA IN
C
E~TEVA~300MG;30MG~A~088324~001~~Dec 29, 1983~No~DISCN~TEVA PHARMACEUTICALS USA I
NC
E~TEVA~300MG;60MG~A~088599~001~~Jun 1, 1984~No~DISCN~TEVA PHARMACEUTICALS USA IN
C
ACETAMINOPHEN; HYDROCODONE BITARTRATE~CAPSULE;ORAL~ACETAMINOPHEN AND HYDROCODONE
BITARTRATE~CENT PHARMS~500MG;5MG~A~088898~001~~Mar 27, 1985~No~DISCN~CENTRAL PH
ARMACEUTICALS INC
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE~CAPSULE;ORAL~ACETAMINOPHEN, ASPIRIN, A
ND CODEINE PHOSPHATE~MIKART~150MG;180MG;15MG~A~081095~001~~Oct 26, 1990~No~DISCN
~MIKART INC
~MIKART INC
~MIKART INC
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE~CAPSULE;ORAL~ACETAMINOPHEN, C
AFFEINE, AND DIHYDROCODEINE BITARTRATE~MIKART~356.4MG;30MG;16MG~A~040109~001~~Au
g 26, 1997~No~DISCN~MIKART INC
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE~CAPSULE;ORAL~ACETAMINOPHEN, C
AFFEINE, AND DIHYDROCODEINE BITARTRATE~WRASER PHARMS LLC~356.4MG;30MG;16MG~A~040
688~001~~Apr 3, 2007~No~DISCN~WRASER PHARMACEUTICALS LLC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~ACHROMYCIN V~HERITAGE PHARMS INC~250MG~N
~050278~003~AB~Approved Prior to Jan 1, 1982~No~RX~HERITAGE PHARMACEUTICALS INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~ACHROMYCIN V~HERITAGE PHARMS INC~500MG~N
~050278~001~AB~Approved Prior to Jan 1, 1982~No~RX~HERITAGE PHARMACEUTICALS INC
ACITRETIN~CAPSULE;ORAL~ACITRETIN~BARR LABS INC~10MG~A~091455~001~AB~Apr 4, 2013~
No~RX~BARR LABORATORIES INC

ACITRETIN~CAPSULE;ORAL~ACITRETIN~BARR LABS INC~25MG~A~091455~002~AB~Apr 4, 2013~
No~RX~BARR LABORATORIES INC
ACITRETIN~CAPSULE;ORAL~ACITRETIN~TEVA PHARMS USA~17.5MG~A~202897~001~AB~Apr 4, 2
013~No~RX~TEVA PHARMACEUTICALS USA
ACITRETIN~CAPSULE;ORAL~ACITRETIN~TEVA PHARMS USA~22.5MG~A~202897~002~AB~Apr 4, 2
URSODIOL~CAPSULE;ORAL~ACTIGALL~WATSON PHARMS~150MG~N~019594~001~~Dec 31, 1987~No
~DISCN~WATSON PHARMACEUTICALS INC
URSODIOL~CAPSULE;ORAL~ACTIGALL~WATSON PHARMS~300MG~N~019594~002~AB~Dec 31, 1987~
Yes~RX~WATSON PHARMACEUTICALS INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~ACTAVIS ELIZABETH~200MG~A~074906~001~~Aug 26, 1
997~No~DISCN~ACTAVIS ELIZABETH LLC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~APOTEX INC~200MG~A~075677~001~AB~Sep 28, 2005~N
o~RX~APOTEX INC ETOBICOKE SITE
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~CADILA PHARMS LTD~200MG~A~201445~001~AB~Mar 6,
2014~No~RX~CADILA PHARMACEUTICALS LTD
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~DAVA PHARMS INC~200MG~A~074833~001~AB~Apr 22, 1
997~No~RX~DAVA PHARMACEUTICALS INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~DAVA PHARMS INC~200MG~A~074872~001~~Apr 22, 199
7~No~DISCN~DAVA PHARMACEUTICALS INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~HERITAGE PHARMS INC~200MG~A~074889~001~~Oct 31,
1997~No~DISCN~HERITAGE PHARMACEUTICALS INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~IVAX SUB TEVA PHARMS~200MG~A~074674~001~~Apr 22
, 1997~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~LEK PHARM~200MG~A~074750~001~~Apr 22, 1997~No~D
ISCN~LEK PHARMACEUTICAL AND CHEMICAL CO DD
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~MYLAN~200MG~A~074727~001~AB~Apr 22, 1997~No~RX~
MYLAN PHARMACEUTICALS INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~MYLAN~200MG~A~074977~001~~Apr 13, 1998~No~DISCN
~MYLAN PHARMACEUTICALS INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~RANBAXY~200MG~A~074975~001~AB~Sep 30, 1998~No~R
X~RANBAXY LABORATORIES LTD
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~ROXANE~200MG~A~074570~002~~Apr 22, 1997~No~DISC
N~ROXANE LABORATORIES INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~STASON~200MG~A~075090~001~AB~Jan 26, 1999~No~RX
~STASON INDUSTRIAL CORP
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~TEVA~200MG~A~074578~001~AB~Apr 22, 1997~No~RX~T
EVA PHARMACEUTICALS USA INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~TEVA~200MG~A~074828~001~~Apr 22, 1997~No~DISCN~
TEVA PHARMACEUTICALS USA INC
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~TEVA PHARMS~200MG~A~074914~001~~Nov 26, 1997~No
~DISCN~TEVA PHARMACEUTICALS USA
ACYCLOVIR~CAPSULE;ORAL~ACYCLOVIR~WATSON LABS~200MG~A~075101~001~~Apr 15, 1998~No
~DISCN~WATSON LABORATORIES INC
NIFEDIPINE~CAPSULE;ORAL~ADALAT~BAYER PHARMS~10MG~N~019478~001~~Nov 27, 1985~No~D
ISCN~BAYER PHARMACEUTICALS CORP
NIFEDIPINE~CAPSULE;ORAL~ADALAT~BAYER PHARMS~20MG~N~019478~002~~Sep 17, 1986~No~D
ISCN~BAYER PHARMACEUTICALS CORP
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~ADIPEX-P~TEVA~37.5MG~A~088023~001~AA~Aug
2, 1983~Yes~RX~TEVA PHARMACEUTICALS USA INC
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~CAPSULE;ORAL~ADVIL COLD AND SINUS~PFIZE
R~EQ 200MG FREE ACID AND POTASSIUM SALT;30MG~N~021374~001~~May 30, 2002~Yes~OTC~
PFIZER INC
IBUPROFEN~CAPSULE;ORAL~ADVIL LIQUI-GELS~PFIZER~EQ 200MG FREE ACID AND POTASSIUM
SALT~N~020402~001~~Apr 20, 1995~Yes~OTC~PFIZER INC
IBUPROFEN~CAPSULE;ORAL~ADVIL MIGRAINE LIQUI-GELS~PFIZER~EQ 200MG FREE ACID AND P
OTASSIUM SALT~N~020402~002~~Mar 16, 2000~Yes~OTC~PFIZER INC
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN~CAPSULE;ORAL~ADVIL PM~PFIZER~25MG;EQ 20
0MG FREE ACID AND POTASSIUM SALT~N~021393~001~~Dec 21, 2005~Yes~OTC~PFIZER INC
VITAMIN A PALMITATE~CAPSULE;ORAL~AFAXIN~STERLING WINTHROP~EQ 50,000 UNITS BASE~A

~083187~001~~Approved Prior to Jan 1, 1982~No~DISCN~STERLING WINTHROP INC
AMPRENAVIR~CAPSULE;ORAL~AGENERASE~GLAXOSMITHKLINE~50MG~N~021007~001~~Apr 15, 199
9~No~DISCN~GLAXOSMITHKLINE
AMPRENAVIR~CAPSULE;ORAL~AGENERASE~GLAXOSMITHKLINE~150MG~N~021007~002~~Apr 15, 19
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~AGRYLIN~SHIRE LLC~EQ 0.5MG BASE~N~020333~0
01~AB~Mar 14, 1997~No~RX~SHIRE DEVELOPMENT LLC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~AGRYLIN~SHIRE LLC~EQ 1MG BASE~N~020333~002
~~Mar 14, 1997~No~DISCN~SHIRE DEVELOPMENT LLC
NETUPITANT; PALONOSETRON HYDROCHLORIDE~CAPSULE;ORAL~AKYNZEO~HELSINN HLTHCARE~300
MG;EQ 0.5MG BASE~N~205718~001~~Oct 10, 2014~Yes~RX~HELSINN HEALTHCARE SA
ACETAMINOPHEN; HYDROCODONE BITARTRATE~CAPSULE;ORAL~ALLAY~IVAX PHARMS~500MG;5MG~A
~089907~001~~Jan 13, 1989~No~DISCN~IVAX PHARMACEUTICALS INC
FEXOFENADINE HYDROCHLORIDE~CAPSULE;ORAL~ALLEGRA~SANOFI AVENTIS US~60MG~N~020625~
001~~Jul 25, 1996~No~DISCN~SANOFI AVENTIS US LLC
ORLISTAT~CAPSULE;ORAL~ALLI~GLAXOSMITHKLINE CONS~60MG~N~021887~001~~Feb 7, 2007~Y
es~OTC~GLAXOSMITHKLINE CONSUMER HEALTHCARE
PALONOSETRON HYDROCHLORIDE~CAPSULE;ORAL~ALOXI~HELSINN HLTHCARE~EQ 0.5MG BASE **F
ederal Register determination that product was not discontinued or withdrawn for
safety or efficacy reasons**~N~022233~001~~Aug 22, 2008~No~DISCN~HELSINN HEALTH
CARE SA
VITAMIN A PALMITATE~CAPSULE;ORAL~ALPHALIN~LILLY~EQ 50,000 UNITS BASE~A~080883~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
RAMIPRIL~CAPSULE;ORAL~ALTACE~KING PHARMS~1.25MG~N~019901~001~AB~Jan 28, 1991~No~
RX~KING PHARMACEUTICALS INC
RAMIPRIL~CAPSULE;ORAL~ALTACE~KING PHARMS~2.5MG~N~019901~002~AB~Jan 28, 1991~No~R
X~KING PHARMACEUTICALS INC
RAMIPRIL~CAPSULE;ORAL~ALTACE~KING PHARMS~5MG~N~019901~003~AB~Jan 28, 1991~No~RX~
KING PHARMACEUTICALS INC
RAMIPRIL~CAPSULE;ORAL~ALTACE~KING PHARMS~10MG~N~019901~004~AB~Jan 28, 1991~Yes~R
X~KING PHARMACEUTICALS INC
AMANTADINE HYDROCHLORIDE~CAPSULE;ORAL~AMANTADINE HYDROCHLORIDE~ACTAVIS ELIZABETH
~100MG~A~077659~001~~Feb 23, 2006~No~DISCN~ACTAVIS ELIZABETH LLC
AMANTADINE HYDROCHLORIDE~CAPSULE;ORAL~AMANTADINE HYDROCHLORIDE~BANNER LIFE SCIEN
CES~100MG~A~078720~001~AB~May 29, 2008~No~RX~BANNER LIFE SCIENCES LLC
AMANTADINE HYDROCHLORIDE~CAPSULE;ORAL~AMANTADINE HYDROCHLORIDE~SANDOZ~100MG~A~07
1293~001~AB~Feb 18, 1987~Yes~RX~SANDOZ INC
AMANTADINE HYDROCHLORIDE~CAPSULE;ORAL~AMANTADINE HYDROCHLORIDE~USL PHARMA~100MG~
A~070589~001~AB~Aug 5, 1986~No~RX~USL PHARMA INC
AMANTADINE HYDROCHLORIDE~CAPSULE;ORAL~AMANTADINE HYDROCHLORIDE~WATSON LABS~100MG
~A~071382~001~~Jan 21, 1987~No~DISCN~WATSON LABORATORIES INC
BROMODIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~AMBODRYL~PARKE DAVIS~25MG~N~0079
84~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMCILL~PARKE DAVIS~EQ 250MG BASE~A
~062041~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBE
RT CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMCILL~PARKE DAVIS~EQ 500MG BASE~A
RT CO
LUBIPROSTONE~CAPSULE;ORAL~AMITIZA~SUCAMPO PHARMA LLC~8MCG~N~021908~002~~Apr 29,
2008~No~RX~SUCAMPO PHARMA AMERICAS LLC
LUBIPROSTONE~CAPSULE;ORAL~AMITIZA~SUCAMPO PHARMA LLC~24MCG~N~021908~001~~Jan 31,
2006~Yes~RX~SUCAMPO PHARMA AMERICAS LLC
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE~CAPSULE;ORAL~AMLODIPINE BESYLATE A
ND BENAZEPRIL HYDROCHLORIDE~APOTEX INC~EQ 2.5MG BASE;10MG~A~091431~001~AB~Dec 30
, 2013~No~RX~APOTEX INC
ND BENAZEPRIL HYDROCHLORIDE~APOTEX INC~EQ 5MG BASE;10MG~A~091431~002~AB~Dec 30,
2013~No~RX~APOTEX INC

ND BENAZEPRIL HYDROCHLORIDE~AUROBINDO PHARMA LTD~EQ 2.5MG BASE;10MG~A~202239~001
~AB~Sep 5, 2012~No~RX~AUROBINDO PHARMA LTD
ND BENAZEPRIL HYDROCHLORIDE~AUROBINDO PHARMA LTD~EQ 5MG BASE;10MG~A~202239~002~A
B~Sep 5, 2012~No~RX~AUROBINDO PHARMA LTD
ND BENAZEPRIL HYDROCHLORIDE~AUROBINDO PHARMA LTD~EQ 10MG BASE;20MG~A~202239~005~
AB~Sep 5, 2012~No~RX~AUROBINDO PHARMA LTD
ND BENAZEPRIL HYDROCHLORIDE~AUROBINDO PHARMA LTD~EQ 10MG BASE;40MG~A~202239~006~
AB~Sep 5, 2012~No~RX~AUROBINDO PHARMA LTD
ND BENAZEPRIL HYDROCHLORIDE~DR REDDYS LABS INC~EQ 2.5MG BASE;10MG~A~077183~001~A
B~Apr 15, 2010~No~RX~DR REDDYS LABORATORIES INC
ND BENAZEPRIL HYDROCHLORIDE~DR REDDYS LABS INC~EQ 5MG BASE;10MG~A~077183~002~AB~
Apr 15, 2010~No~RX~DR REDDYS LABORATORIES INC
Apr 15, 2010~No~RX~DR REDDYS LABORATORIES INC
Jul 5, 2011~No~RX~DR REDDYS LABORATORIES INC
ND BENAZEPRIL HYDROCHLORIDE~DR REDDYS LABS INC~EQ 10MG BASE;20MG~A~077183~004~AB
~Apr 15, 2010~No~RX~DR REDDYS LABORATORIES INC
ND BENAZEPRIL HYDROCHLORIDE~DR REDDYS LABS INC~EQ 10MG BASE;40MG~A~090149~002~AB
~Jul 5, 2011~No~RX~DR REDDYS LABORATORIES INC
ND BENAZEPRIL HYDROCHLORIDE~LUPIN PHARMS~EQ 2.5MG BASE;10MG~A~078466~001~AB~Feb
5, 2010~No~RX~LUPIN PHARMACEUTICALS INC
ND BENAZEPRIL HYDROCHLORIDE~LUPIN PHARMS~EQ 5MG BASE;10MG~A~078466~002~AB~Feb 5,
2010~No~RX~LUPIN PHARMACEUTICALS INC
ND BENAZEPRIL HYDROCHLORIDE~LUPIN PHARMS~EQ 5MG BASE;20MG~A~078466~003~AB~Feb 5,
ND BENAZEPRIL HYDROCHLORIDE~LUPIN PHARMS~EQ 5MG BASE;40MG~A~078466~005~AB~Jul 5,

ND BENAZEPRIL HYDROCHLORIDE~LUPIN PHARMS~EQ 10MG BASE;20MG~A~078466~004~AB~Feb 5
, 2010~No~RX~LUPIN PHARMACEUTICALS INC
ND BENAZEPRIL HYDROCHLORIDE~LUPIN PHARMS~EQ 10MG BASE;40MG~A~078466~006~AB~Jul 5
, 2011~No~RX~LUPIN PHARMACEUTICALS INC
ND BENAZEPRIL HYDROCHLORIDE~MYLAN~EQ 2.5MG BASE;10MG~A~077375~001~AB~May 21, 201
0~No~RX~MYLAN PHARMACEUTICALS INC
ND BENAZEPRIL HYDROCHLORIDE~MYLAN~EQ 5MG BASE;10MG~A~077375~002~AB~May 21, 2010~
No~RX~MYLAN PHARMACEUTICALS INC
ND BENAZEPRIL HYDROCHLORIDE~MYLAN~EQ 5MG BASE;20MG~A~077375~003~AB~May 21, 2010~
ND BENAZEPRIL HYDROCHLORIDE~MYLAN~EQ 5MG BASE;40MG~A~079047~001~AB~Jul 5, 2011~N
o~RX~MYLAN PHARMACEUTICALS INC
ND BENAZEPRIL HYDROCHLORIDE~MYLAN~EQ 10MG BASE;20MG~A~077375~004~AB~May 21, 2010
~No~RX~MYLAN PHARMACEUTICALS INC
ND BENAZEPRIL HYDROCHLORIDE~MYLAN~EQ 10MG BASE;40MG~A~079047~002~AB~Jul 5, 2011~
ND BENAZEPRIL HYDROCHLORIDE~PAR PHARM~EQ 2.5MG BASE;10MG~A~078381~001~AB~Jul 29,
2010~No~RX~PAR PHARMACEUTICAL INC
ND BENAZEPRIL HYDROCHLORIDE~PAR PHARM~EQ 5MG BASE;10MG~A~078381~002~AB~Jul 29, 2
ND BENAZEPRIL HYDROCHLORIDE~PAR PHARM~EQ 10MG BASE;20MG~A~078381~004~AB~Jul 29,
ND BENAZEPRIL HYDROCHLORIDE~PAR PHARM~EQ 10MG BASE;40MG~A~078381~006~AB~Jul 29,
ND BENAZEPRIL HYDROCHLORIDE~TEVA PHARMS~EQ 2.5MG BASE;10MG~A~077179~001~AB~May 1
8, 2007~No~RX~TEVA PHARMACEUTICALS USA
ND BENAZEPRIL HYDROCHLORIDE~TEVA PHARMS~EQ 5MG BASE;10MG~A~077179~002~AB~May 18,
ND BENAZEPRIL HYDROCHLORIDE~TEVA PHARMS~EQ 5MG BASE;20MG~A~077179~003~AB~May 18,
ND BENAZEPRIL HYDROCHLORIDE~TEVA PHARMS~EQ 5MG BASE;40MG~A~077179~005~AB~Jul 5,
ND BENAZEPRIL HYDROCHLORIDE~TEVA PHARMS~EQ 10MG BASE;20MG~A~077179~004~AB~May 18
, 2007~No~RX~TEVA PHARMACEUTICALS USA
ND BENAZEPRIL HYDROCHLORIDE~TEVA PHARMS~EQ 10MG BASE;40MG~A~077179~006~AB~Jul 5,

ND BENAZEPRIL HYDROCHLORIDE~WATSON LABS~EQ 2.5MG BASE;10MG~A~077890~001~AB~Oct 1
4, 2010~No~RX~WATSON LABORATORIES INC
ND BENAZEPRIL HYDROCHLORIDE~WATSON LABS~EQ 5MG BASE;10MG~A~077890~002~AB~Oct 14,
2010~No~RX~WATSON LABORATORIES INC
ND BENAZEPRIL HYDROCHLORIDE~WATSON LABS~EQ 5MG BASE;20MG~A~077890~003~AB~Oct 14,
ND BENAZEPRIL HYDROCHLORIDE~WATSON LABS~EQ 10MG BASE;20MG~A~077890~004~AB~Oct 14
, 2010~No~RX~WATSON LABORATORIES INC
ND BENAZEPRIL HYDROCHLORIDE~WATSON LABS INC~EQ 5MG BASE;40MG~A~090364~001~AB~Jul
ND BENAZEPRIL HYDROCHLORIDE~WATSON LABS INC~EQ 10MG BASE;40MG~A~090364~002~AB~Ju
l 5, 2011~No~RX~WATSON LABORATORIES INC
ISOTRETINOIN~CAPSULE;ORAL~AMNESTEEM~MYLAN PHARMS INC~10MG~A~075945~001~AB~Nov 8,
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~AM ANTIBIOTICS~250MG~A~062058~001~AB~Approv
ed Prior to Jan 1, 1982~No~RX~AMERICAN ANTIBIOTICS INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~AM ANTIBIOTICS~500MG~A~062058~002~AB~Approv
ed Prior to Jan 1, 1982~No~RX~AMERICAN ANTIBIOTICS INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~AUROBINDO~250MG~A~065271~001~AB~Nov 9, 2005
~No~RX~AUROBINDO PHARMA LTD
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~AUROBINDO~500MG~A~065271~002~AB~Nov 9, 2005
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~DAVA PHARMS INC~250MG~A~062884~001~AB~Feb 2
5, 1988~No~RX~DAVA PHARMACEUTICALS INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~DAVA PHARMS INC~500MG~A~062881~001~AB~Feb 2
5, 1988~No~RX~DAVA PHARMACEUTICALS INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~HIKMA PHARMS~250MG~A~065291~001~AB~Feb 5, 2
007~No~RX~HIKMA PHARMACEUTICALS
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~HIKMA PHARMS~500MG~A~065291~002~AB~Feb 5, 2
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~LABS ATRAL~250MG~A~062528~001~~Aug 7, 1985~
No~DISCN~LABORATORIOS ATRAL SARL
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~LABS ATRAL~500MG~A~062528~002~~Aug 7, 1985~
No~DISCN~LABORATORIOS ATRAL SARL
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~MYLAN~250MG~A~062067~001~~Approved Prior to
Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~MYLAN~500MG~A~062067~002~~Approved Prior to
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~RANBAXY~250MG~A~065016~001~AB~Apr 8, 1999~N
o~RX~RANBAXY PHARMACEUTICALS INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~RANBAXY~500MG~A~065016~002~AB~Apr 8, 1999~N
o~RX~RANBAXY PHARMACEUTICALS INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~SANDOZ~250MG~A~064076~001~AB~Sep 30, 1994~N
o~RX~SANDOZ INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~SANDOZ~500MG~A~064076~002~AB~Sep 30, 1994~N
o~RX~SANDOZ INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~TEVA~250MG~A~061926~001~AB~Approved Prior t
o Jan 1, 1982~No~RX~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~TEVA~250MG~A~062853~001~~Dec 22, 1987~No~DI
SCN~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~TEVA~250MG~A~063030~001~~Feb 28, 1989~No~DI

AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~TEVA~500MG~A~061926~003~AB~Approved Prior t
o Jan 1, 1982~Yes~RX~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~TEVA~500MG~A~062854~001~~Dec 22, 1987~No~DI
AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~TEVA~500MG~A~063031~001~~Feb 28, 1989~No~DI
AMOXICILLIN~CAPSULE;ORAL~AMOXIL~DR REDDYS LABS INC~250MG~A~062216~001~AB~Approve
d Prior to Jan 1, 1982~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~CAPSULE;ORAL~AMOXIL~DR REDDYS LABS INC~500MG~A~062216~004~AB~Approve
d Prior to Jan 1, 1982~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~CAPSULE;ORAL~AMOXIL~GLAXOSMITHKLINE~250MG~N~050459~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
AMOXICILLIN~CAPSULE;ORAL~AMOXIL~GLAXOSMITHKLINE~500MG~N~050459~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CHLORAMPHENICOL~CAPSULE;ORAL~AMPHICOL~FERRANTE~100MG~A~060058~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~AM ANTIBIOTI
CS~EQ 250MG BASE~A~061602~001~~Approved Prior to Jan 1, 1982~No~DISCN~AMERICAN A
NTIBIOTICS LLC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~AM ANTIBIOTI
CS~EQ 500MG BASE~A~061602~002~~Approved Prior to Jan 1, 1982~No~DISCN~AMERICAN A
NTIBIOTICS LLC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~DAVA PHARMS
INC~EQ 250MG BASE~A~062883~001~AB~Feb 25, 1988~No~RX~DAVA PHARMACEUTICALS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~DAVA PHARMS
INC~EQ 500MG BASE~A~062882~001~AB~Feb 25, 1988~Yes~RX~DAVA PHARMACEUTICALS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~IVAX SUB TEV
A PHARMS~EQ 250MG BASE~A~060765~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX
PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~IVAX SUB TEV
A PHARMS~EQ 500MG BASE~A~060765~002~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX
PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~LEDERLE~EQ 2
50MG BASE~A~062208~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATOR
IES DIV AMERICAN CYANAMID CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~LEDERLE~EQ 5
00MG BASE~A~062208~002~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATOR
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~MYLAN~EQ 250
MG BASE~A~061755~001~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICA
LS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~MYLAN~EQ 500
MG BASE~A~061755~002~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICA
LS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~PUREPAC PHAR
M~EQ 250MG BASE~A~061853~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHA
RMACEUTICAL CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~PUREPAC PHAR
M~EQ 500MG BASE~A~061853~002~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHA
RMACEUTICAL CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~SANDOZ~EQ 25
0MG BASE~A~064082~001~AB~Aug 29, 1995~No~RX~SANDOZ INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~SANDOZ~EQ 50
0MG BASE~A~064082~002~AB~Aug 29, 1995~No~RX~SANDOZ INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~TEVA~EQ 250M
G BASE~A~061502~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS
USA INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~TEVA~EQ 500M
G BASE~A~061502~002~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS

USA INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~VITARINE~EQ
250MG BASE~A~061387~001~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMAC
EUTICALS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~AMPICILLIN TRIHYDRATE~VITARINE~EQ
500MG BASE~A~061387~003~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMAC
EUTICALS INC
CLOMIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~ANAFRANIL~MALLINCKRODT LLC~25MG~N~019906
~001~AB~Dec 29, 1989~No~RX~MALLINCKRODT LLC
~002~AB~Dec 29, 1989~Yes~RX~MALLINCKRODT LLC
~003~AB~Dec 29, 1989~No~RX~MALLINCKRODT LLC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~BARR~EQ 0.5MG BAS
E~A~076530~001~AB~Apr 18, 2005~No~RX~BARR LABORATORIES INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~BARR~EQ 1MG BASE~
A~076530~002~AB~Apr 18, 2005~No~RX~BARR LABORATORIES INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~IMPAX LABS~EQ 0.5
MG BASE~A~076910~001~AB~Apr 18, 2005~No~RX~IMPAX LABORATORIES INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~IMPAX LABS~EQ 1MG
BASE~A~076910~002~AB~Apr 18, 2005~No~RX~IMPAX LABORATORIES INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~IVAX SUB TEVA PHA
RMS~EQ 0.5MG BASE~A~076468~001~AB~Apr 18, 2005~No~RX~IVAX PHARMACEUTICALS INC SU
B TEVA PHARMACEUTICALS USA
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~IVAX SUB TEVA PHA
RMS~EQ 1MG BASE~A~076468~002~AB~Apr 18, 2005~Yes~RX~IVAX PHARMACEUTICALS INC SUB
TEVA PHARMACEUTICALS USA
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~MYLAN~EQ 0.5MG BA
SE~A~076811~001~AB~Apr 18, 2005~No~RX~MYLAN LABORATORIES INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~MYLAN~EQ 1MG BASE
~A~076811~002~AB~Apr 18, 2005~No~RX~MYLAN LABORATORIES INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~MYLAN PHARMS INC~
EQ 0.5MG BASE~A~077613~001~AB~Jun 27, 2006~No~RX~MYLAN PHARMACEUTICALS INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~MYLAN PHARMS INC~
EQ 1MG BASE~A~077613~002~AB~Jun 27, 2006~No~RX~MYLAN PHARMACEUTICALS INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~ROXANE~EQ 0.5MG B
ASE~A~076489~001~~Apr 18, 2005~No~DISCN~ROXANE LABORATORIES INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~ROXANE~EQ 1MG BAS
E~A~076489~002~~Apr 18, 2005~No~DISCN~ROXANE LABORATORIES INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~SANDOZ INC~EQ 0.5
MG BASE~A~076683~001~~Apr 18, 2005~No~DISCN~SANDOZ INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~SANDOZ INC~EQ 1MG
BASE~A~076683~002~~Apr 18, 2005~No~DISCN~SANDOZ INC
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~WATSON LABS~EQ 0.
5MG BASE~A~076417~001~~Apr 18, 2005~No~DISCN~WATSON LABORATORIES
ANAGRELIDE HYDROCHLORIDE~CAPSULE;ORAL~ANAGRELIDE HYDROCHLORIDE~WATSON LABS~EQ 1M
G BASE~A~076417~002~~Apr 18, 2005~No~DISCN~WATSON LABORATORIES
FLUCYTOSINE~CAPSULE;ORAL~ANCOBON~VALEANT~250MG~N~017001~001~AB~Approved Prior to
Jan 1, 1982~No~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
FLUCYTOSINE~CAPSULE;ORAL~ANCOBON~VALEANT~500MG~N~017001~002~AB~Approved Prior to
Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~ANOQUAN~SHIRE~325MG;50MG;40MG~A
~087628~001~~Oct 1, 1986~No~DISCN~SHIRE DEVELOPMENT INC
CEPHRADINE~CAPSULE;ORAL~ANSPOR~GLAXOSMITHKLINE~250MG~A~061859~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CEPHRADINE~CAPSULE;ORAL~ANSPOR~GLAXOSMITHKLINE~500MG~A~061859~002~~Approved Prio
FENOFIBRATE~CAPSULE;ORAL~ANTARA (MICRONIZED)~LUPIN ATLANTIS~30MG~N~021695~004~~O
ct 18, 2013~No~RX~LUPIN ATLANTIS HOLDINGS SA
FENOFIBRATE~CAPSULE;ORAL~ANTARA (MICRONIZED)~LUPIN ATLANTIS~43MG~N~021695~001~AB

~Nov 30, 2004~No~RX~LUPIN ATLANTIS HOLDINGS SA
FENOFIBRATE~CAPSULE;ORAL~ANTARA (MICRONIZED)~LUPIN ATLANTIS~87MG~N~021695~002~~N
ov 30, 2004~No~DISCN~LUPIN ATLANTIS HOLDINGS SA
FENOFIBRATE~CAPSULE;ORAL~ANTARA (MICRONIZED)~LUPIN ATLANTIS~90MG~N~021695~005~~O
ct 18, 2013~No~RX~LUPIN ATLANTIS HOLDINGS SA
FENOFIBRATE~CAPSULE;ORAL~ANTARA (MICRONIZED)~LUPIN ATLANTIS~130MG~N~021695~003~A
B~Nov 30, 2004~Yes~RX~LUPIN ATLANTIS HOLDINGS SA
SULFINPYRAZONE~CAPSULE;ORAL~ANTURANE~NOVARTIS~200MG **Federal Register determina
ns**~N~011556~004~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICA
LS CORP
APREPITANT~CAPSULE;ORAL~APREPITANT~SANDOZ~40MG~A~090999~001~AB~Sep 24, 2012~No~R
X~SANDOZ INC
APREPITANT~CAPSULE;ORAL~APREPITANT~SANDOZ~80MG~A~090999~002~AB~Sep 24, 2012~No~R
X~SANDOZ INC
APREPITANT~CAPSULE;ORAL~APREPITANT~SANDOZ~125MG~A~090999~003~AB~Sep 24, 2012~No~
RX~SANDOZ INC
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~APRESAZIDE~NOVARTIS~
25MG;25MG~A~084735~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACE
UTICALS CORP
50MG;50MG~A~084810~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACE
UTICALS CORP
100MG;50MG~A~084811~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMAC
EUTICALS CORP
TIPRANAVIR~CAPSULE;ORAL~APTIVUS~BOEHRINGER INGELHEIM~250MG~N~021814~001~~Jun 22,
2005~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
VITAMIN A~CAPSULE;ORAL~AQUASOL A~ASTRAZENECA~25,000USP UNITS~A~083080~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA LP
VITAMIN A~CAPSULE;ORAL~AQUASOL A~ASTRAZENECA~50,000USP UNITS~A~083080~001~~Appro
ASPIRIN~CAPSULE;ORAL~ASPIRIN~PLX PHARMA~325MG~N~203697~001~~Jan 14, 2013~Yes~OTC
~PLX PHARMA INC
ATAZANAVIR SULFATE~CAPSULE;ORAL~ATAZANAVIR SULFATE~TEVA PHARMS USA~EQ 100MG BASE
~A~091673~001~~Apr 22, 2014~No~RX~TEVA PHARMACEUTICALS USA
~A~091673~002~AB~Apr 22, 2014~No~RX~TEVA PHARMACEUTICALS USA
ATOMOXETINE HYDROCHLORIDE~CAPSULE;ORAL~ATOMOXETINE HYDROCHLORIDE~ZYDUS PHARMS US
A INC~18MG~A~079017~001~~Sep 17, 2010~No~DISCN~ZYDUS PHARMACEUTICALS USA INC
CLOFIBRATE~CAPSULE;ORAL~ATROMID-S~WYETH AYERST~500MG~N~016099~002~~Approved Prio
r to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
NORTRIPTYLINE HYDROCHLORIDE~CAPSULE;ORAL~AVENTYL HYDROCHLORIDE~LILLY~EQ 10MG BAS
E~N~014684~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
NORTRIPTYLINE HYDROCHLORIDE~CAPSULE;ORAL~AVENTYL HYDROCHLORIDE~LILLY~EQ 25MG BAS
E~N~014684~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO

DUTASTERIDE~CAPSULE;ORAL~AVODART~GLAXOSMITHKLINE~0.5MG~N~021319~001~AB~Nov 20, 2
001~Yes~RX~GLAXOSMITHKLINE
NIZATIDINE~CAPSULE;ORAL~AXID~SMITHKLINE BEECHAM~150MG~N~019508~001~~Apr 12, 1988
~No~DISCN~SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
NIZATIDINE~CAPSULE;ORAL~AXID~SMITHKLINE BEECHAM~300MG~N~019508~002~~Apr 12, 1988
~No~DISCN~SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
PHENYLBUTAZONE~CAPSULE;ORAL~AZOLID~SANOFI AVENTIS US~100MG~A~087260~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
OXACILLIN SODIUM~CAPSULE;ORAL~BACTOCILL~GLAXOSMITHKLINE~EQ 250MG BASE~A~061336~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
BALSALAZIDE DISODIUM~CAPSULE;ORAL~BALSALAZIDE DISODIUM~APOTEX INC~750MG~A~077883
~001~AB~Dec 28, 2007~No~RX~APOTEX INC ETOBICOKE SITE
BALSALAZIDE DISODIUM~CAPSULE;ORAL~BALSALAZIDE DISODIUM~MYLAN~750MG~A~077807~001~
AB~Dec 28, 2007~No~RX~MYLAN PHARMACEUTICALS INC
BALSALAZIDE DISODIUM~CAPSULE;ORAL~BALSALAZIDE DISODIUM~ROXANE~750MG~A~077806~001
~AB~Dec 28, 2007~No~RX~ROXANE LABORATORIES INC
ACETAMINOPHEN; BUTALBITAL~CAPSULE;ORAL~BANCAP~FOREST PHARMS~325MG;50MG~A~088889~
001~~Jan 16, 1986~No~DISCN~FOREST PHARMACEUTICALS INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~CAPSULE;ORAL~BANCAP HC~FOREST PHARMS~500MG
;5MG~A~087961~001~~Mar 17, 1983~No~DISCN~FOREST PHARMACEUTICALS INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~BENADRYL~MCNEIL CONS~25MG~N~005845~00
7~~Approved Prior to Jan 1, 1982~No~DISCN~MCNEIL CONSUMER HEALTHCARE
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~BENADRYL~MCNEIL CONS~50MG~N~005845~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~MCNEIL CONSUMER HEALTHCARE
LEVODOPA~CAPSULE;ORAL~BENDOPA~VALEANT PHARM INTL~100MG~N~016948~003~~Approved Pr
ior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
DICYCLOMINE HYDROCHLORIDE~CAPSULE;ORAL~BENTYL~FOREST LABS INC~10MG~N~007409~003~
AB~Oct 15, 1984~Yes~RX~FOREST LABORATORIES INC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~APOTEX INC~100MG~A~091310~001~AA~Jan 16, 20
15~No~RX~APOTEX INC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~APOTEX INC~200MG~A~091310~002~AA~Jan 16, 20
15~No~RX~APOTEX INC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~BANNER LIFE SCIENCES~100MG~A~081297~001~AA~
Jan 29, 1993~No~RX~BANNER LIFE SCIENCES LLC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~BANNER LIFE SCIENCES~200MG~A~081297~002~AA~
Oct 30, 2007~No~RX~BANNER LIFE SCIENCES LLC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~MIKART~100MG~A~040851~001~AA~Nov 9, 2009~No
~RX~MIKART INC
~RX~MIKART INC
~RX~MIKART INC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~NESHER PHARMS~100MG~A~040795~001~~Oct 31, 2
007~No~DISCN~NESHER PHARMACEUTICALS USA LLC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~NESHER PHARMS~200MG~A~040795~002~~Oct 31, 2
BENZONATATE~CAPSULE;ORAL~BENZONATATE~ORIT LABS LLC~100MG~A~040682~001~AA~Jul 30,
2007~No~RX~ORIT LABORATORIES LLC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~ORIT LABS LLC~200MG~A~040682~002~AA~Jul 30,
2007~No~RX~ORIT LABORATORIES LLC

BENZONATATE~CAPSULE;ORAL~BENZONATATE~SUN PHARM INDS INC~100MG~A~040587~001~AA~Ma
r 19, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~SUN PHARM INDS INC~200MG~A~040587~002~AA~Ma
BENZONATATE~CAPSULE;ORAL~BENZONATATE~THE PHARMA NETWORK~100MG~A~040627~001~AA~Ma
r 30, 2007~Yes~RX~THE PHARMA NETWORK LLC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~THE PHARMA NETWORK~200MG~A~040749~001~AA~Ju
l 25, 2007~Yes~RX~THE PHARMA NETWORK LLC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~THEPHARMANETWORK LLC~150MG~A~201209~001~AA~
Sep 24, 2014~Yes~RX~THEPHARMANETWORK LLC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~ZYDUS PHARMS USA~100MG~A~040597~001~AA~Jun
8, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
BENZONATATE~CAPSULE;ORAL~BENZONATATE~ZYDUS PHARMS USA~200MG~A~040597~002~AA~Jun
BEXAROTENE~CAPSULE;ORAL~BEXAROTENE~BANNER LIFE SCIENCES~75MG~A~203174~001~~Aug 1
2, 2014~No~DISCN~BANNER LIFE SCIENCES LLC
IPODATE SODIUM~CAPSULE;ORAL~BILIVIST~BAYER HLTHCARE~500MG~A~087768~001~~Aug 11,
1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
TYROPANOATE SODIUM~CAPSULE;ORAL~BILOPAQUE~GE HEALTHCARE~750MG~N~013731~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
PAROXETINE MESYLATE~CAPSULE;ORAL~BRISDELLE~NOVEN THERAP~EQ 7.5MG BASE~N~204516~0
01~~Jun 28, 2013~Yes~RX~NOVEN THERAPEUTICS LLC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~BRISTACYCLINE~BRISTOL~250MG~A~061658~001
~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL MY
ERS CO
ERS CO
ERS CO
ERS CO
BROMOCRIPTINE MESYLATE~CAPSULE;ORAL~BROMOCRIPTINE MESYLATE~LEK PHARM~EQ 5MG BASE
~A~075100~001~~Dec 10, 1998~No~DISCN~LEK PHARMACEUTICAL AND CHEMICAL CO DD
BROMOCRIPTINE MESYLATE~CAPSULE;ORAL~BROMOCRIPTINE MESYLATE~MYLAN~EQ 5MG BASE~A~0
77226~001~AB~Apr 4, 2005~No~RX~MYLAN PHARMACEUTICALS INC
BROMOCRIPTINE MESYLATE~CAPSULE;ORAL~BROMOCRIPTINE MESYLATE~ZYDUS PHARMS USA INC~
EQ 5MG BASE~A~078899~001~AB~Jul 30, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
THEOPHYLLINE~CAPSULE;ORAL~BRONKODYL~SANOFI AVENTIS US~100MG~A~085264~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
THEOPHYLLINE~CAPSULE;ORAL~BRONKODYL~SANOFI AVENTIS US~200MG~A~085264~002~~Approv
ACETAMINOPHEN; BUTALBITAL~CAPSULE;ORAL~BUCET~MALLINCKRODT~650MG;50MG~A~088991~00
1~~Jun 28, 1985~No~DISCN~MALLINCKRODT CHEMICAL INC
BUDESONIDE~CAPSULE;ORAL~BUDESONIDE~BARR LABS DIV TEVA~3MG~A~090379~001~AB~Apr 2,
2014~No~RX~BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA
BUDESONIDE~CAPSULE;ORAL~BUDESONIDE~MYLAN~3MG~A~090410~001~AB~May 16, 2011~No~RX~
BUSPIRONE HYDROCHLORIDE~CAPSULE;ORAL~BUSPAR~BRISTOL MYERS SQUIBB~5MG~N~021190~00
1~~Dec 20, 2000~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITU
TE
BUSPIRONE HYDROCHLORIDE~CAPSULE;ORAL~BUSPAR~BRISTOL MYERS SQUIBB~7.5MG~N~021190~
002~~Dec 20, 2000~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTI
TUTE
03~~Dec 20, 2000~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTIT
UTE

04~~Dec 20, 2000~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTIT
UTE
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~BUTALBITAL, ACETAMINOPHEN AND C
AFFEINE~GRAHAM DM~325MG;50MG;40MG~A~088743~001~~Jul 18, 1985~No~DISCN~DM GRAHAM
LABORATORIES INC
AFFEINE~GRAHAM DM~325MG;50MG;40MG~A~088765~001~~Mar 27, 1985~No~DISCN~DM GRAHAM
LABORATORIES INC
AFFEINE~GRAHAM DM~325MG;50MG;40MG~A~089067~001~~Apr 19, 1985~No~DISCN~DM GRAHAM
LABORATORIES INC
AFFEINE~HIKMA PHARMS LLC~500MG;50MG;40MG~A~040261~001~~Oct 28, 1998~No~DISCN~HIK
MA PHARMACEUTICALS LLC
AFFEINE~MALLINCKRODT~325MG;50MG;40MG~A~088758~001~~Mar 27, 1985~No~DISCN~MALLINC
KRODT CHEMICAL INC
AFFEINE~MIKART~325MG;50MG;40MG~A~089007~001~~Mar 17, 1986~Yes~RX~MIKART INC
AFFEINE~NEXGEN PHARMA~300MG;50MG;40MG~A~040885~001~~Nov 16, 2009~Yes~RX~NEXGEN P
HARMA INC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE~CAPSULE;ORAL~BUTALBITAL,
ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE~ABLE~325MG;50MG;40MG;30MG~A~076528
~001~~Aug 21, 2003~No~DISCN~ABLE LABORATORIES INC
ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE~HIKMA INTL PHARMS~325MG;50MG;40MG;
30MG~A~075618~001~AB~Mar 23, 2001~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE~NEXGEN PHARMA INC~300MG;50MG;40MG;
30MG~A~076560~002~~Jul 19, 2012~No~RX~NEXGEN PHARMA INC
ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE~NEXGEN PHARMA INC~325MG;50MG;40MG;
30MG~A~076560~001~AB~Jun 10, 2004~No~RX~NEXGEN PHARMA INC
ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE~VINTAGE PHARMS~325MG;50MG;40MG;30M
G~A~075929~001~AB~Apr 22, 2002~No~RX~VINTAGE PHARMACEUTICALS INC
ASPIRIN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~MUTU
AL PHARM~325MG;50MG;40MG~A~078149~001~~Jun 13, 2007~No~DISCN~MUTUAL PHARMACEUTIC
AL CO INC
ASPIRIN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~WATS
ON LABS~325MG;50MG;40MG~A~086231~002~~Feb 12, 1985~No~DISCN~WATSON LABORATORIES
INC
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE~CAPSULE;ORAL~BUTALBITAL, ASPIRI
N, CAFFEINE, AND CODEINE PHOSPHATE~NEXGEN PHARMA INC~325MG;50MG;40MG;30MG~A~0752
31~001~AB~Nov 30, 2001~No~RX~NEXGEN PHARMA INC
N, CAFFEINE, AND CODEINE PHOSPHATE~STEVENS J~325MG;50MG;40MG;30MG~A~074951~001~A
B~Aug 31, 1998~No~RX~JEROME STEVENS PHARMACEUTICALS INC
N, CAFFEINE, AND CODEINE PHOSPHATE~VINTAGE PHARMS LLC~325MG;50MG;40MG;30MG~A~075
351~001~~Mar 5, 1999~No~DISCN~VINTAGE PHARMACEUTICALS LLC
N, CAFFEINE, AND CODEINE PHOSPHATE~WATSON LABS~325MG;50MG;40MG;30MG~A~074359~001
~~Aug 31, 1995~No~DISCN~WATSON LABORATORIES INC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~BUTALIBITAL, ACETAMINOPHEN AND
CAFFEINE~GILBERT LABS~325MG;50MG;40MG~A~088825~001~~Dec 5, 1984~No~DISCN~GILBERT
LABORATORIES
PHENYLBUTAZONE~CAPSULE;ORAL~BUTAZOLIDIN~NOVARTIS~100MG~N~008319~009~~Approved Pr
ior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP

BUTABARBITAL SODIUM~CAPSULE;ORAL~BUTICAPS~MEDPOINTE PHARM HLC~15MG~A~085381~001~
~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEAL
THCARE INC
THCARE INC
THCARE INC
BUTABARBITAL SODIUM~CAPSULE;ORAL~BUTICAPS~MEDPOINTE PHARM HLC~100MG~A~085381~004
~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEA
LTHCARE INC
CALCITRIOL~CAPSULE;ORAL~CALCITRIOL~BANNER LIFE SCIENCES~0.25MCG~A~091174~001~AB~
May 24, 2013~No~RX~BANNER LIFE SCIENCES LLC
CALCITRIOL~CAPSULE;ORAL~CALCITRIOL~BANNER LIFE SCIENCES~0.5MCG~A~091174~002~AB~M
ay 24, 2013~No~RX~BANNER LIFE SCIENCES LLC
CALCITRIOL~CAPSULE;ORAL~CALCITRIOL~ROXANE~0.25MCG~A~076917~001~AB~Mar 27, 2006~N
o~RX~ROXANE LABORATORIES INC
CALCITRIOL~CAPSULE;ORAL~CALCITRIOL~STRIDES PHARMA~0.25MCG~A~091356~001~AB~Dec 12
, 2014~No~RX~STRIDES PHARMA GLOBAL PTE LTD
CALCITRIOL~CAPSULE;ORAL~CALCITRIOL~STRIDES PHARMA~0.5MCG~A~091356~002~AB~Dec 12,
2014~No~RX~STRIDES PHARMA GLOBAL PTE LTD
CALCITRIOL~CAPSULE;ORAL~CALCITRIOL~TEVA~0.25MCG~A~075765~001~AB~Oct 12, 2001~No~
RX~TEVA PHARMACEUTICALS USA INC
CALCITRIOL~CAPSULE;ORAL~CALCITRIOL~TEVA~0.5MCG~A~075765~002~AB~Oct 12, 2001~No~R
X~TEVA PHARMACEUTICALS USA INC
CALCIUM ACETATE~CAPSULE;ORAL~CALCIUM ACETATE~AMNEAL PHARMS~EQ 169MG CALCIUM~A~20
1658~001~AB~Oct 6, 2014~No~RX~AMNEAL PHARMACEUTICALS
CALCIUM ACETATE~CAPSULE;ORAL~CALCIUM ACETATE~INVAGEN PHARMS~EQ 169MG CALCIUM~A~2
03135~001~AB~Feb 7, 2013~No~RX~INVAGEN PHARMACEUTICALS INC
CALCIUM ACETATE~CAPSULE;ORAL~CALCIUM ACETATE~PADDOCK LLC~EQ 169MG CALCIUM~A~0913
12~001~AB~Jun 1, 2012~No~RX~PADDOCK LABORATORIES LLC
CALCIUM ACETATE~CAPSULE;ORAL~CALCIUM ACETATE~ROXANE~EQ 169MG CALCIUM~A~077728~00
1~AB~Feb 26, 2008~No~RX~ROXANE LABORATORIES INC
CALCIFEDIOL~CAPSULE;ORAL~CALDEROL~ORGANON USA INC~0.02MG~N~018312~001~~Approved
Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
CALCIFEDIOL~CAPSULE;ORAL~CALDEROL~ORGANON USA INC~0.05MG~N~018312~002~~Approved
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~CARDENE~CHIESI USA INC~20MG~N~019488~001~
AB~Dec 21, 1988~No~RX~CHIESI USA INC
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~CARDENE~CHIESI USA INC~30MG~N~019488~002~
AB~Dec 21, 1988~Yes~RX~CHIESI USA INC
CEFACLOR~CAPSULE;ORAL~CECLOR~LILLY~EQ 250MG BASE~N~050521~001~~Approved Prior to
Jan 1, 1982~No~DISCN~ELI LILLY AND CO
CEFACLOR~CAPSULE;ORAL~CECLOR~LILLY~EQ 500MG BASE~N~050521~002~~Approved Prior to
CEFTIBUTEN DIHYDRATE~CAPSULE;ORAL~CEDAX~PERNIX THERAP~EQ 400MG BASE~N~050685~002
~~Dec 20, 1995~Yes~RX~PERNIX THERAPEUTICS LLC
CEFACLOR~CAPSULE;ORAL~CEFACLOR~CEPH INTL~EQ 250MG BASE~A~062205~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~CEPH INTERNATIONAL CORP
CEFACLOR~CAPSULE;ORAL~CEFACLOR~CEPH INTL~EQ 500MG BASE~A~062205~002~~Approved Pr
ior to Jan 1, 1982~No~DISCN~CEPH INTERNATIONAL CORP
CEFACLOR~CAPSULE;ORAL~CEFACLOR~DAVA PHARMS INC~EQ 250MG BASE~A~064107~001~~Apr 2
7, 1995~No~DISCN~DAVA PHARMACEUTICALS INC
CEFACLOR~CAPSULE;ORAL~CEFACLOR~DAVA PHARMS INC~EQ 500MG BASE~A~064107~002~~Apr 2
7, 1995~No~DISCN~DAVA PHARMACEUTICALS INC
CEFACLOR~CAPSULE;ORAL~CEFACLOR~HIKMA~EQ 250MG BASE~A~065350~001~AB~Apr 3, 2007~N
o~RX~HIKMA PHARMACEUTICALS
CEFACLOR~CAPSULE;ORAL~CEFACLOR~HIKMA~EQ 500MG BASE~A~065350~002~AB~Apr 3, 2007~Y
es~RX~HIKMA PHARMACEUTICALS
CEFACLOR~CAPSULE;ORAL~CEFACLOR~IVAX SUB TEVA PHARMS~EQ 250MG BASE~A~064061~001~~
Apr 27, 1995~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CEFACLOR~CAPSULE;ORAL~CEFACLOR~IVAX SUB TEVA PHARMS~EQ 500MG BASE~A~064061~002~~
Apr 27, 1995~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CEFACLOR~CAPSULE;ORAL~CEFACLOR~RANBAXY~EQ 250MG BASE~A~064156~001~~Aug 28, 1997~
No~DISCN~RANBAXY PHARMACEUTICALS INC
CEFACLOR~CAPSULE;ORAL~CEFACLOR~RANBAXY~EQ 500MG BASE~A~064156~002~~Aug 28, 1997~
No~DISCN~RANBAXY PHARMACEUTICALS INC
CEFACLOR~CAPSULE;ORAL~CEFACLOR~TEVA~EQ 250MG BASE~A~064081~001~~Sep 16, 1996~No~
DISCN~TEVA PHARMACEUTICALS USA INC
CEFACLOR~CAPSULE;ORAL~CEFACLOR~TEVA~EQ 250MG BASE~A~064145~001~~Jun 24, 1996~No~
CEFACLOR~CAPSULE;ORAL~CEFACLOR~TEVA~EQ 500MG BASE~A~064081~002~~Sep 16, 1996~No~
CEFACLOR~CAPSULE;ORAL~CEFACLOR~TEVA~EQ 500MG BASE~A~064145~002~~Jun 24, 1996~No~
CEFACLOR~CAPSULE;ORAL~CEFACLOR~WATSON LABS INC~EQ 250MG BASE~A~064148~001~~May 2
3, 1996~No~DISCN~WATSON LABORATORIES INC
CEFACLOR~CAPSULE;ORAL~CEFACLOR~WATSON LABS INC~EQ 500MG BASE~A~064148~002~~May 2
CEFACLOR~CAPSULE;ORAL~CEFACLOR~YUNG SHIN PHARM~EQ 250MG BASE~A~065146~001~AB~Jan
22, 2004~No~RX~YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEFACLOR~CAPSULE;ORAL~CEFACLOR~YUNG SHIN PHARM~EQ 500MG BASE~A~065146~002~AB~Jan
22, 2004~No~RX~YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~AUROBINDO PHARMA~EQ 50
0MG BASE~A~065352~001~AB~Jan 25, 2007~No~RX~AUROBINDO PHARMA LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~HIKMA~EQ 500MG BASE~A~
065311~001~AB~Feb 7, 2006~No~RX~HIKMA PHARMACEUTICALS
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~IVAX SUB TEVA PHARMS~E
Q 500MG BASE~A~062766~001~~Mar 3, 1987~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEV
A PHARMACEUTICALS USA
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~LUPIN~EQ 500MG BASE~A~
065392~001~AB~May 29, 2007~No~RX~LUPIN LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~ORCHID HLTHCARE~EQ 500
MG BASE~A~065309~001~AB~Sep 18, 2006~No~RX~ORCHID HEALTHCARE
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~PUREPAC PHARM~EQ 500MG
BASE~A~063017~001~~Jan 5, 1989~No~DISCN~PUREPAC PHARMACEUTICAL CO
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~RANBAXY LABS LTD~EQ 50
0MG BASE~A~065015~001~~Jun 22, 1999~No~DISCN~RANBAXY LABORATORIES LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~SANDOZ~EQ 500MG BASE~A
~062291~001~AB~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~TEVA~EQ 500MG BASE~A~0
62695~001~~Feb 10, 1989~No~DISCN~TEVA PHARMACEUTICALS USA INC
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~CEFADROXIL~TEVA PHARMS~EQ 500MG B
ASE~A~065282~001~AB~Jan 20, 2006~Yes~RX~TEVA PHARMACEUTICALS USA
CEFDINIR~CAPSULE;ORAL~CEFDINIR~AUROBINDO PHARMA~300MG~A~065434~001~AB~Jan 7, 200
8~No~RX~AUROBINDO PHARMA LTD
CEFDINIR~CAPSULE;ORAL~CEFDINIR~LUPIN~300MG~A~065264~001~AB~May 19, 2006~No~RX~LU
PIN LTD
CEFDINIR~CAPSULE;ORAL~CEFDINIR~ORCHID HLTHCARE~300MG~A~065418~001~AB~Jul 18, 200
7~No~RX~ORCHID HEALTHCARE
CEFDINIR~CAPSULE;ORAL~CEFDINIR~SANDOZ~300MG~A~065330~001~AB~Apr 6, 2007~Yes~RX~S
ANDOZ INC
CEFDINIR~CAPSULE;ORAL~CEFDINIR~TEVA PHARMS~300MG~A~065368~001~AB~May 9, 2007~No~
RX~TEVA PHARMACEUTICALS USA
CELECOXIB~CAPSULE;ORAL~CELEBREX~GD SEARLE~50MG~N~020998~004~AB~Dec 15, 2006~No~R
X~GD SEARLE LLC
CELECOXIB~CAPSULE;ORAL~CELEBREX~GD SEARLE~100MG~N~020998~001~AB~Dec 31, 1998~No~
RX~GD SEARLE LLC
CELECOXIB~CAPSULE;ORAL~CELEBREX~GD SEARLE~200MG~N~020998~002~AB~Dec 31, 1998~No~

RX~GD SEARLE LLC
CELECOXIB~CAPSULE;ORAL~CELEBREX~GD SEARLE~400MG~N~020998~003~AB~Aug 29, 2002~Yes
~RX~GD SEARLE LLC
CELECOXIB~CAPSULE;ORAL~CELECOXIB~LUPIN LTD~50MG~A~202240~001~AB~Oct 29, 2014~No~
RX~LUPIN LTD
CELECOXIB~CAPSULE;ORAL~CELECOXIB~MYLAN PHARMS INC~50MG~A~078857~001~AB~May 30, 2
CELECOXIB~CAPSULE;ORAL~CELECOXIB~MYLAN PHARMS INC~100MG~A~078857~002~AB~Feb 11,
CELECOXIB~CAPSULE;ORAL~CELECOXIB~TEVA~50MG~A~076898~001~AB~May 30, 2014~No~RX~TE
VA PHARMACEUTICALS USA INC
CELECOXIB~CAPSULE;ORAL~CELECOXIB~TEVA~100MG~A~076898~002~AB~May 30, 2014~No~RX~T
CELECOXIB~CAPSULE;ORAL~CELECOXIB~WATSON LABS INC~50MG~A~200562~001~AB~Feb 11, 20
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~CELLCEPT~ROCHE PALO~250MG~N~050722~001~AB~May
3, 1995~Yes~RX~ROCHE PALO ALTO LLC
METHSUXIMIDE~CAPSULE;ORAL~CELONTIN~PARKE DAVIS~150MG~N~010596~007~~Approved Prio
r to Jan 1, 1982~No~RX~PARKE DAVIS DIV WARNER LAMBERT CO
METHSUXIMIDE~CAPSULE;ORAL~CELONTIN~PARKE DAVIS~300MG~N~010596~008~~Approved Prio
r to Jan 1, 1982~Yes~RX~PARKE DAVIS DIV WARNER LAMBERT CO
PRAZEPAM~CAPSULE;ORAL~CENTRAX~PARKE DAVIS~5MG~N~018144~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
PRAZEPAM~CAPSULE;ORAL~CENTRAX~PARKE DAVIS~10MG~N~018144~002~~Approved Prior to J
an 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
PRAZEPAM~CAPSULE;ORAL~CENTRAX~PARKE DAVIS~20MG~N~018144~003~~May 10, 1982~No~DIS
CN~PARKE DAVIS DIV WARNER LAMBERT CO
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~ALKEM LABS LTD~EQ 250MG BASE~A~090836~001~AB~
Dec 20, 2010~No~RX~ALKEM LABORATORIES LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~ALKEM LABS LTD~EQ 333MG BASE~A~090836~003~~Ma
r 29, 2013~No~RX~ALKEM LABORATORIES LTD
Dec 20, 2010~No~RX~ALKEM LABORATORIES LTD
Mar 29, 2013~No~RX~ALKEM LABORATORIES LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~APOTHECON~EQ 250MG BASE~A~062973~001~~Nov 8,
1988~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~APOTHECON~EQ 250MG BASE~A~063063~001~~Sep 29,
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~APOTHECON~EQ 250MG BASE~A~063186~001~~Dec 30,
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~APOTHECON~EQ 500MG BASE~A~062974~001~~Nov 23,
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~APOTHECON~EQ 500MG BASE~A~063063~002~~Sep 29,
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~APOTHECON~EQ 500MG BASE~A~063186~002~~Dec 30,

CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~AUROBINDO PHARMA LTD~EQ 250MG BASE~A~065253~0
01~AB~Nov 16, 2005~No~RX~AUROBINDO PHARMA LTD INC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~AUROBINDO PHARMA LTD~EQ 500MG BASE~A~065253~0
02~AB~Nov 16, 2005~No~RX~AUROBINDO PHARMA LTD INC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~BARR~EQ 250MG BASE~A~062773~001~~Jun 26, 1987
~No~DISCN~BARR LABORATORIES INC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~BARR~EQ 500MG BASE~A~062775~001~~Apr 22, 1987
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~BELCHER PHARMS~EQ 250MG BASE~A~062713~001~AB~
Jul 15, 1988~No~RX~BELCHER PHARMACEUTICALS LLC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~BELCHER PHARMS~EQ 500MG BASE~A~062713~002~AB~
Jul 15, 1988~No~RX~BELCHER PHARMACEUTICALS LLC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~FACTA FARMA~EQ 250MG BASE~A~062118~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~FACTA FARMACEUTICI SPA
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~FACTA FARMA~EQ 500MG BASE~A~062118~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~FACTA FARMACEUTICI SPA
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~HIKMA~EQ 250MG BASE~A~065215~001~AB~Jan 24, 2
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~HIKMA~EQ 500MG BASE~A~065215~002~AB~Jan 24, 2
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~IVAX SUB TEVA PHARMS~EQ 250MG BASE~A~061969~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHA
RMACEUTICALS USA
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~IVAX SUB TEVA PHARMS~EQ 500MG BASE~A~061969~0
02~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHA
RMACEUTICALS USA
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~LUPIN~EQ 250MG BASE~A~065229~001~AB~Nov 25, 2
005~No~RX~LUPIN LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~LUPIN~EQ 500MG BASE~A~065229~002~AB~Nov 25, 2
005~No~RX~LUPIN LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~ORCHID HLTHCARE~EQ 250MG BASE~A~065248~001~AB
~Jun 28, 2005~No~RX~ORCHID HEALTHCARE
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~ORCHID HLTHCARE~EQ 500MG BASE~A~065248~002~AB
~Jun 28, 2005~No~RX~ORCHID HEALTHCARE
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~PUREPAC PHARM~EQ 250MG BASE~A~062809~001~~Apr
22, 1987~No~DISCN~PUREPAC PHARMACEUTICAL CO
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~PUREPAC PHARM~EQ 500MG BASE~A~062809~002~~Apr
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~RANBAXY~EQ 250MG BASE~A~065007~001~AB~Sep 16,
1999~No~RX~RANBAXY LABORATORIES LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~RANBAXY~EQ 500MG BASE~A~065007~002~AB~Sep 16,
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~STEVENS J~EQ 250MG BASE~A~062870~001~~Mar 17,
1988~No~DISCN~JEROME STEVENS PHARMACEUTICALS INC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~STEVENS J~EQ 500MG BASE~A~062869~001~~Mar 17,
1988~No~DISCN~JEROME STEVENS PHARMACEUTICALS INC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~SUN PHARM INDS (IN)~EQ 250MG BASE~A~062791~00
1~AB~Jun 11, 1987~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~SUN PHARM INDS (IN)~EQ 500MG BASE~A~062791~00
2~AB~Jun 11, 1987~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~TEVA~EQ 250MG BASE~A~062702~001~AB~Feb 13, 19
87~No~RX~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~TEVA~EQ 250MG BASE~A~062760~001~~Apr 24, 1987
~No~DISCN~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~TEVA~EQ 250MG BASE~A~062821~001~~Feb 5, 1988~
No~DISCN~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~TEVA~EQ 500MG BASE~A~062702~002~AB~Feb 13, 19
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~TEVA~EQ 500MG BASE~A~062761~001~~Apr 24, 1987

CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~TEVA~EQ 500MG BASE~A~062823~001~~Feb 5, 1988~
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~YOSHITOMI~EQ 250MG BASE~A~062872~001~~Jun 20,
1988~No~DISCN~YOSHITOMI PHARMACEUTICAL INDUSTRIES LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~YOSHITOMI~EQ 500MG BASE~A~062871~001~~Jul 5,
1988~No~DISCN~YOSHITOMI PHARMACEUTICAL INDUSTRIES LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~YUNG SHIN PHARM~EQ 250MG BASE~A~065152~001~AB
~Feb 24, 2005~No~RX~YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~YUNG SHIN PHARM~EQ 500MG BASE~A~065152~002~AB
~Feb 24, 2005~No~RX~YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEPHRADINE~CAPSULE;ORAL~CEPHRADINE~BARR~250MG~A~062850~001~~Apr 22, 1988~No~DISC
N~BARR LABORATORIES INC
CEPHRADINE~CAPSULE;ORAL~CEPHRADINE~BARR~500MG~A~062851~001~~Apr 22, 1988~No~DISC
N~BARR LABORATORIES INC
CEPHRADINE~CAPSULE;ORAL~CEPHRADINE~IVAX SUB TEVA PHARMS~250MG~A~062762~001~~Mar
6, 1987~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CEPHRADINE~CAPSULE;ORAL~CEPHRADINE~IVAX SUB TEVA PHARMS~500MG~A~062762~002~~Mar
CEPHRADINE~CAPSULE;ORAL~CEPHRADINE~TEVA~250MG~A~062683~001~~Jan 9, 1987~No~DISCN
~TEVA PHARMACEUTICALS USA INC
CEPHRADINE~CAPSULE;ORAL~CEPHRADINE~TEVA~500MG~A~062683~002~~Jan 9, 1987~No~DISCN
CEPHRADINE~CAPSULE;ORAL~CEPHRADINE~VITARINE~250MG~A~062813~001~~Feb 25, 1988~No~
DISCN~VITARINE PHARMACEUTICALS INC
CEPHRADINE~CAPSULE;ORAL~CEPHRADINE~VITARINE~500MG~A~062813~002~~Feb 25, 1988~No~
DISCN~VITARINE PHARMACEUTICALS INC
ELIGLUSTAT TARTRATE~CAPSULE;ORAL~CERDELGA~GENZYME CORP~EQ 84MG BASE~N~205494~001
~~Aug 19, 2014~Yes~RX~GENZYME CORP
NABILONE~CAPSULE;ORAL~CESAMET~MEDA PHARMS~1MG~N~018677~001~~Dec 26, 1985~Yes~RX~
MEDA PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~CAPSULE;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~BANNER LI
FE SCIENCES~5MG~N~022429~001~~Jul 23, 2009~No~OTC~BANNER LIFE SCIENCES LLC
CETIRIZINE HYDROCHLORIDE~CAPSULE;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~BANNER LI
FE SCIENCES~10MG~N~022429~004~~Jul 23, 2009~Yes~OTC~BANNER LIFE SCIENCES LLC
CETIRIZINE HYDROCHLORIDE~CAPSULE;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RELIEF~BANN
ER LIFE SCIENCES~5MG~N~022429~003~~Jul 23, 2009~No~OTC~BANNER LIFE SCIENCES LLC
CETIRIZINE HYDROCHLORIDE~CAPSULE;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RELIEF~BANN
ER LIFE SCIENCES~10MG~N~022429~002~~Jul 23, 2009~Yes~OTC~BANNER LIFE SCIENCES LL
C
CEVIMELINE HYDROCHLORIDE~CAPSULE;ORAL~CEVIMELINE~APOTEX INC~30MG~A~091260~001~AB
~Aug 25, 2011~No~RX~APOTEX INC
CEVIMELINE HYDROCHLORIDE~CAPSULE;ORAL~CEVIMELINE HYDROCHLORIDE~PACK PHARMS LLC~3
0MG~A~203775~001~AB~Jun 4, 2014~No~RX~PACK PHARMACEUTICALS LLC
CEVIMELINE HYDROCHLORIDE~CAPSULE;ORAL~CEVIMELINE HYDROCHLORIDE~ROXANE~30MG~A~091
591~001~AB~Jul 8, 2013~No~RX~ROXANE LABORATORIES INC
SUCCIMER~CAPSULE;ORAL~CHEMET~RECORDATI RARE~100MG~N~019998~002~~Jan 30, 1991~Yes
~RX~RECORDATI RARE DISEASES INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZACHEL~RACHELLE~5MG~A~085086
~001~~Approved Prior to Jan 1, 1982~No~DISCN~RACHELLE LABORATORIES INC
9~001~~Approved Prior to Jan 1, 1982~No~DISCN~RACHELLE LABORATORIES INC
7~001~~Approved Prior to Jan 1, 1982~No~DISCN~RACHELLE LABORATORIES INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~ASCOT
~5MG~A~087525~001~~Jan 7, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVE
NOL LABORATORIES INC
~10MG~A~087524~001~~Jan 7, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAV
ENOL LABORATORIES INC

~25MG~A~087512~001~~Jan 7, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAV
ENOL LABORATORIES INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~BARR~
5MG~A~084768~001~AB~Approved Prior to Jan 1, 1982~No~RX~BARR LABORATORIES INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~FERRA
NTE~5MG~A~085118~001~~Approved Prior to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~HALSE
Y~5MG~A~085340~001~~Approved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~HIKMA
PHARMS LLC~5MG~A~085014~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHARM
ACEUTICALS LLC
PHARMS LLC~10MG~A~085000~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHAR
MACEUTICALS LLC
PHARMS LLC~25MG~A~085294~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHAR
MACEUTICALS LLC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~IMPAX
LABS~5MG~A~086213~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIE
S INC
LABS~10MG~A~085113~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORI
ES INC
LABS~25MG~A~086212~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORI
ES INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~IVAX
SUB TEVA PHARMS~5MG~A~083741~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PH
ARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
SUB TEVA PHARMS~10MG~A~083742~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX P
HARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
SUB TEVA PHARMS~25MG~A~083570~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX P
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~LEDER
LE~5MG~A~086892~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES
DIV AMERICAN CYANAMID CO
LE~5MG~A~087234~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES
LE~10MG~A~086876~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIE
S DIV AMERICAN CYANAMID CO

CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~MAST
MM~10MG~A~086217~001~~Approved Prior to Jan 1, 1982~No~DISCN~MM MAST AND CO
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~MYLAN
~5MG~A~084886~001~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS
INC
INC
INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~PARKE
DAVIS~5MG~A~085163~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV
WARNER LAMBERT CO
WARNER LAMBERT CO
WARNER LAMBERT CO
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~PIONE
ER PHARMS~10MG~A~089533~001~~Jul 15, 1988~No~DISCN~PIONEER PHARMACEUTICALS INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~PIONE
ER PHARMS~25MG~A~089558~001~~Jul 15, 1988~No~DISCN~PIONEER PHARMACEUTICALS INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~PUREP
AC PHARM~5MG~A~085155~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMA
CEUTICAL CO
AC PHARM~10MG~A~084939~002~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARM
ACEUTICAL CO
AC PHARM~25MG~A~085144~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARM
ACEUTICAL CO
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~ROXAN
E~5MG~A~084706~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES I
NC
E~10MG~A~084700~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES
INC
E~25MG~A~084705~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES
INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~SANDO
Z~5MG~A~084678~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC

CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~SUPER
PHARM~5MG~A~088987~001~~Apr 25, 1985~No~DISCN~SUPERPHARM CORP
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~TEVA~
5MG~A~088705~001~~Jan 18, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
25MG~A~086494~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS U
SA INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~USL P
HARMA~5MG~A~084644~001~~Approved Prior to Jan 1, 1982~No~DISCN~USL PHARMA INC
HARMA~10MG~A~084623~001~AB~Approved Prior to Jan 1, 1982~No~RX~USL PHARMA INC
HARMA~25MG~A~084645~001~~Approved Prior to Jan 1, 1982~No~DISCN~USL PHARMA INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~VANGA
RD~5MG~A~088129~001~~Mar 28, 1983~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY M
EDICAL CO
RD~10MG~A~088010~001~~Mar 28, 1983~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY
MEDICAL CO
RD~25MG~A~088130~001~~Mar 28, 1983~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY
MEDICAL CO
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~CHLORDIAZEPOXIDE HYDROCHLORIDE~WATSO
N LABS~5MG~A~086383~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATOR
IES INC
N LABS~10MG~A~086294~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATO
RIES INC
N LABS~25MG~A~086382~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATO
RIES INC
CHLORAMPHENICOL~CAPSULE;ORAL~CHLOROMYCETIN~PARKEDALE~50MG~A~060591~001~~Approved
Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
CHLORAMPHENICOL~CAPSULE;ORAL~CHLOROMYCETIN~PARKEDALE~100MG~A~060591~003~~Approve
d Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
CHLOROTRIANISENE~CAPSULE;ORAL~CHLOROTRIANISENE~BANNER PHARMACAPS~12MG~A~084652~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~BANNER PHARMACAPS INC
QUINIDINE SULFATE~CAPSULE;ORAL~CIN-QUIN~SOLVAY~200MG~A~085296~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
QUINIDINE SULFATE~CAPSULE;ORAL~CIN-QUIN~SOLVAY~300MG~A~085297~001~~Approved Prio
RESCINNAMINE~CAPSULE;ORAL~CINNASIL~PANRAY~0.5MG~A~084736~001~~Approved Prior to
Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
CINOXACIN~CAPSULE;ORAL~CINOBAC~LILLY~250MG~N~018067~001~~Approved Prior to Jan 1
, 1982~No~DISCN~ELI LILLY AND CO
CINOXACIN~CAPSULE;ORAL~CINOBAC~LILLY~500MG~N~018067~002~~Approved Prior to Jan 1
CINOXACIN~CAPSULE;ORAL~CINOXACIN~TEVA~250MG~A~073005~001~~Feb 28, 1992~No~DISCN~
CINOXACIN~CAPSULE;ORAL~CINOXACIN~TEVA~500MG~A~073006~001~~Feb 28, 1992~No~DISCN~
CITALOPRAM HYDROBROMIDE~CAPSULE;ORAL~CITALOPRAM HYDROBROMIDE~MYLAN PHARMS INC~EQ

10MG BASE~A~077668~001~~Feb 28, 2007~No~RX~MYLAN PHARMACEUTICALS INC
20MG BASE~A~077668~002~~Feb 28, 2007~No~RX~MYLAN PHARMACEUTICALS INC
40MG BASE~A~077668~003~~Feb 28, 2007~Yes~RX~MYLAN PHARMACEUTICALS INC
ISOTRETINOIN~CAPSULE;ORAL~CLARAVIS~TEVA PHARMS USA~10MG~A~076356~001~AB~Apr 11,
ISOTRETINOIN~CAPSULE;ORAL~CLARAVIS~TEVA PHARMS USA~30MG~A~076135~003~AB~May 11,
2003~Yes~RX~TEVA PHARMACEUTICALS USA
LORATADINE~CAPSULE;ORAL~CLARITIN~SCHERING PLOUGH~10MG~N~021952~001~~Jun 16, 2008
~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLEOCIN~PHARMACIA AND UPJOHN~EQ 75MG BASE
~A~061809~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLEOCIN~PHARMACIA AND UPJOHN~EQ 150MG BAS
E~A~061809~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLEOCIN HYDROCHLORIDE~PHARMACIA AND UPJOH
N~EQ 75MG BASE~N~050162~001~AB~Approved Prior to Jan 1, 1982~No~RX~PHARMACIA AND
UPJOHN CO
N~EQ 150MG BASE~N~050162~002~AB~Approved Prior to Jan 1, 1982~No~RX~PHARMACIA AN
D UPJOHN CO
N~EQ 300MG BASE~N~050162~003~AB~Apr 14, 1988~Yes~RX~PHARMACIA AND UPJOHN CO
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~AUROBINDO PHARM
A~EQ 150MG BASE~A~065442~001~AB~Aug 26, 2009~No~RX~AUROBINDO PHARMA LTD
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~AUROBINDO PHARM
A~EQ 300MG BASE~A~065442~002~AB~Aug 26, 2009~No~RX~AUROBINDO PHARMA LTD
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~COREPHARMA~EQ 1
50MG BASE~A~065194~001~AB~Mar 22, 2004~No~RX~COREPHARMA LLC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~COREPHARMA~EQ 3
00MG BASE~A~065194~002~AB~Mar 22, 2004~No~RX~COREPHARMA LLC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~LANNETT~EQ 75MG
BASE~A~065242~001~AB~Aug 12, 2005~No~RX~LANNETT HOLDINGS INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~LANNETT~EQ 150M
G BASE~A~065242~002~AB~Aug 12, 2005~No~RX~LANNETT HOLDINGS INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~LANNETT~EQ 300M
G BASE~A~065243~001~AB~Aug 12, 2005~No~RX~LANNETT HOLDINGS INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~MYLAN PHARMS IN
C~EQ 75MG BASE~A~091225~001~AB~May 31, 2011~No~RX~MYLAN PHARMACEUTICALS INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~RANBAXY~EQ 150M
G BASE~A~065061~001~AB~Feb 2, 2001~No~RX~RANBAXY LABORATORIES LTD
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~RANBAXY~EQ 300M
G BASE~A~065061~002~AB~Feb 2, 2001~No~RX~RANBAXY LABORATORIES LTD
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~TEVA~EQ 75MG BA
SE~A~063027~001~~Sep 20, 1989~No~DISCN~TEVA PHARMACEUTICALS USA INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~TEVA~EQ 150MG B
ASE~A~063029~001~AB~Sep 20, 1989~No~RX~TEVA PHARMACEUTICALS USA INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~TEVA~EQ 300MG B
ASE~A~063029~002~AB~Aug 5, 2005~No~RX~TEVA PHARMACEUTICALS USA INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~WATSON LABS~EQ
75MG BASE~A~063082~001~~Jul 31, 1991~No~DISCN~WATSON LABORATORIES INC

150MG BASE~A~063083~001~AB~Jul 31, 1991~No~RX~WATSON LABORATORIES INC
300MG BASE~A~063083~002~AB~Mar 18, 2003~No~RX~WATSON LABORATORIES INC
CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~ZYDUS PHARMS US
A~EQ 75MG BASE~A~065217~001~AB~Jan 31, 2005~No~RX~ZYDUS PHARMACEUTICALS USA INC
CLOFIBRATE~CAPSULE;ORAL~CLOFIBRATE~BANNER PHARMACAPS~500MG~A~073396~001~~Mar 20,
1992~No~DISCN~BANNER PHARMACAPS INC
CLOFIBRATE~CAPSULE;ORAL~CLOFIBRATE~SANDOZ~500MG~A~072191~001~~May 2, 1988~No~DIS
CN~SANDOZ INC
CLOFIBRATE~CAPSULE;ORAL~CLOFIBRATE~TEVA~500MG~A~072600~001~~Jul 25, 1991~No~DISC
N~TEVA PHARMACEUTICALS USA INC
CLOFIBRATE~CAPSULE;ORAL~CLOFIBRATE~USL PHARMA~500MG~A~070531~001~~Jun 16, 1986~N
o~DISCN~USL PHARMA INC
CLOFIBRATE~CAPSULE;ORAL~CLOFIBRATE~WATSON LABS~500MG~A~071603~001~~Sep 18, 1987~
No~DISCN~WATSON LABORATORIES INC
CLOMIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~CLOMIPRAMINE HYDROCHLORIDE~MYLAN~25MG~A~
CLOMIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~CLOMIPRAMINE HYDROCHLORIDE~SANDOZ~25MG~A
~074364~001~AB~Mar 29, 1996~No~RX~SANDOZ INC
~074953~001~~Jun 25, 1997~No~DISCN~SANDOZ INC
CLOMIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~CLOMIPRAMINE HYDROCHLORIDE~TARO~25MG~A~0
74694~001~AB~Dec 31, 1996~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
CLOMIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~CLOMIPRAMINE HYDROCHLORIDE~TEVA~25MG~A~0
74849~001~~Apr 4, 1997~No~DISCN~TEVA PHARMACEUTICALS USA INC
74958~001~AB~Aug 26, 1997~No~RX~TEVA PHARMACEUTICALS USA INC
CLOMIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~CLOMIPRAMINE HYDROCHLORIDE~WATSON LABS~2
5MG~A~074600~001~~Nov 27, 1996~No~DISCN~WATSON LABORATORIES INC
5MG~A~074751~001~~Sep 30, 1998~No~DISCN~WATSON LABORATORIES INC

CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~ABLE~3.75MG~A~07177
7~001~~Jul 14, 1987~No~DISCN~ABLE LABORATORIES INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~ABLE~7.5MG~A~071778
~001~~Jul 14, 1987~No~DISCN~ABLE LABORATORIES INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~ABLE~15MG~A~071779~
001~~Jul 14, 1987~No~DISCN~ABLE LABORATORIES INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~AM THERAP~3.75MG~A~
071429~001~~Jun 23, 1987~No~DISCN~AMERICAN THERAPEUTICS INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~AM THERAP~7.5MG~A~0
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~AM THERAP~15MG~A~07
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~DAVA PHARMS INC~3.7
5MG~A~071742~001~~Dec 14, 1987~No~DISCN~DAVA PHARMACEUTICALS INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~DAVA PHARMS INC~7.5
MG~A~071743~001~~Dec 14, 1987~No~DISCN~DAVA PHARMACEUTICALS INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~DAVA PHARMS INC~15M
G~A~071744~001~~Dec 14, 1987~No~DISCN~DAVA PHARMACEUTICALS INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~GD SEARLE LLC~3.75M
G~A~071727~001~~Dec 18, 1987~No~DISCN~GD SEARLE LLC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~GD SEARLE LLC~7.5MG
~A~071728~001~~Dec 18, 1987~No~DISCN~GD SEARLE LLC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~GD SEARLE LLC~15MG~
A~071729~001~~Dec 18, 1987~No~DISCN~GD SEARLE LLC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~MYLAN~3.75MG~A~0715
09~001~~Oct 19, 1987~No~DISCN~MYLAN PHARMACEUTICALS INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~MYLAN~7.5MG~A~07151
0~001~~Oct 19, 1987~No~DISCN~MYLAN PHARMACEUTICALS INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~MYLAN~15MG~A~071511
~001~~Oct 19, 1987~No~DISCN~MYLAN PHARMACEUTICALS INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~PUREPAC PHARM~3.75M
G~A~071924~001~~Apr 25, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~PUREPAC PHARM~7.5MG
~A~071925~001~~Apr 25, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~PUREPAC PHARM~15MG~
A~071926~001~~Apr 25, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~QUANTUM PHARMICS~3.
75MG~A~071549~001~~Sep 12, 1988~No~DISCN~QUANTUM PHARMICS LTD
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~QUANTUM PHARMICS~7.
5MG~A~071550~001~~Sep 12, 1988~No~DISCN~QUANTUM PHARMICS LTD
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~QUANTUM PHARMICS~15
MG~A~071522~001~~Sep 12, 1988~No~DISCN~QUANTUM PHARMICS LTD
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~SANDOZ~3.75MG~A~072
219~001~~Aug 26, 1988~No~DISCN~SANDOZ INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~SANDOZ~7.5MG~A~0722
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~SANDOZ~15MG~A~07211
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~USL PHARMA~3.75MG~A
~071242~001~~Jun 23, 1987~No~DISCN~USL PHARMA INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~USL PHARMA~7.5MG~A~
071243~001~~Jun 23, 1987~No~DISCN~USL PHARMA INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~USL PHARMA~15MG~A~0

71244~001~~Jun 23, 1987~No~DISCN~USL PHARMA INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~WARNER CHILCOTT~3.7
5MG~A~071774~001~~Mar 1, 1988~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~WARNER CHILCOTT~7.5
MG~A~071775~001~~Mar 1, 1988~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~WARNER CHILCOTT~15M
G~A~071776~001~~Mar 1, 1988~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~WATSON LABS~3.75MG~
A~071878~001~~Mar 15, 1988~No~DISCN~WATSON LABORATORIES INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~WATSON LABS~7.5MG~A
~071879~001~~Mar 15, 1988~No~DISCN~WATSON LABORATORIES INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~WATSON LABS~15MG~A~
071860~001~~Mar 15, 1988~No~DISCN~WATSON LABORATORIES INC
CLOXACILLIN SODIUM~CAPSULE;ORAL~CLOXACILLIN SODIUM~APOTHECON~EQ 250MG BASE~A~061
452~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS
SQUIBB
CLOXACILLIN SODIUM~CAPSULE;ORAL~CLOXACILLIN SODIUM~APOTHECON~EQ 500MG BASE~A~061
SQUIBB
CLOXACILLIN SODIUM~CAPSULE;ORAL~CLOXACILLIN SODIUM~TEVA~EQ 250MG BASE~A~062240~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
CLOXACILLIN SODIUM~CAPSULE;ORAL~CLOXACILLIN SODIUM~TEVA~EQ 500MG BASE~A~062240~0
CLOXACILLIN SODIUM~CAPSULE;ORAL~CLOXAPEN~GLAXOSMITHKLINE~EQ 250MG BASE~A~061806~
ACETAMINOPHEN; HYDROCODONE BITARTRATE~CAPSULE;ORAL~CO-GESIC~CENT PHARMS~500MG;5M
G~A~089360~001~~Mar 2, 1988~No~DISCN~CENTRAL PHARMACEUTICALS INC
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE~CAPSULE;ORAL~CODEINE, ASPIRIN, APAP FO
RMULA NO. 2~SCHERER LABS~150MG;180MG;15MG~A~085640~001~~Approved Prior to Jan 1,
1982~No~DISCN~SCHERER LABORATORIES INC
TACRINE HYDROCHLORIDE~CAPSULE;ORAL~COGNEX~SHIONOGI INC~EQ 10MG BASE~N~020070~001
~~Sep 9, 1993~No~DISCN~SHIONOGI INC
BALSALAZIDE DISODIUM~CAPSULE;ORAL~COLAZAL~SALIX PHARMS~750MG~N~020610~001~AB~Jul
18, 2000~Yes~RX~SALIX PHARMACEUTICALS INC
CABOZANTINIB S-MALATE~CAPSULE;ORAL~COMETRIQ~EXELIXIS~EQ 20MG BASE~N~203756~001~~
Nov 29, 2012~No~RX~EXELIXIS INC
CABOZANTINIB S-MALATE~CAPSULE;ORAL~COMETRIQ~EXELIXIS~EQ 80MG BASE~N~203756~002~~
Nov 29, 2012~Yes~RX~EXELIXIS INC
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~COMPOUND 65~ALRA~389M
G;32.4MG;65MG~A~084553~002~~Aug 17, 1983~No~DISCN~ALRA LABORATORIES INC
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~CAPSULE;ORAL~COTAZYM~ORGANON USA INC~30,0
00USP UNITS;8,000USP UNITS;30,000USP UNITS~N~020580~001~~Dec 9, 1996~No~DISCN~OR

GANON USA INC
INDINAVIR SULFATE~CAPSULE;ORAL~CRIXIVAN~MERCK SHARP DOHME~EQ 100MG BASE~N~020685
~006~~Apr 19, 2000~No~DISCN~MERCK SHARP AND DOHME CORP
~003~~Mar 13, 1996~No~RX~MERCK SHARP AND DOHME CORP
~005~~Dec 17, 1998~No~DISCN~MERCK SHARP AND DOHME CORP
~001~~Mar 13, 1996~Yes~RX~MERCK SHARP AND DOHME CORP
PENICILLAMINE~CAPSULE;ORAL~CUPRIMINE~ATON~125MG~N~019853~002~~Approved Prior to
Jan 1, 1982~No~DISCN~ATON PHARMA INC
PENICILLAMINE~CAPSULE;ORAL~CUPRIMINE~ATON~250MG~N~019853~001~~Approved Prior to
Jan 1, 1982~Yes~RX~ATON PHARMA INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~CYCLOPAR~WARNER CHILCOTT~250MG~A~061725~
001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT C
O
O
O
O
O
CYCLOPHOSPHAMIDE~CAPSULE;ORAL~CYCLOPHOSPHAMIDE~ROXANE~25MG~N~203856~001~~Sep 16,
2013~No~RX~ROXANE LABORATORIES INC
CYCLOPHOSPHAMIDE~CAPSULE;ORAL~CYCLOPHOSPHAMIDE~ROXANE~50MG~N~203856~002~~Sep 16,
2013~Yes~RX~ROXANE LABORATORIES INC
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~APOTEX~25MG~A~065040~001~AB2~May 9, 2002~
No~RX~APOTEX INC
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~APOTEX~100MG~A~065040~002~AB2~May 9, 2002
~No~RX~APOTEX INC
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~IVAX SUB TEVA PHARMS~25MG~A~065110~003~AB
1~Mar 29, 2005~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~IVAX SUB TEVA PHARMS~50MG~A~065110~001~AB
1~Mar 29, 2005~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~IVAX SUB TEVA PHARMS~100MG~A~065110~002~A
B1~Mar 29, 2005~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~SANDOZ~25MG~A~065017~002~AB1~Jan 13, 2000
~No~RX~SANDOZ INC
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~SANDOZ~100MG~A~065017~001~AB1~Jan 13, 200
0~No~RX~SANDOZ INC
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~WATSON LABS INC~25MG~A~065044~002~AB1~Dec
CYCLOSPORINE~CAPSULE;ORAL~CYCLOSPORINE~WATSON LABS INC~100MG~A~065044~001~AB1~De
c 20, 2000~No~RX~WATSON LABORATORIES INC
CYSTEAMINE BITARTRATE~CAPSULE;ORAL~CYSTAGON~MYLAN~EQ 50MG BASE~N~020392~001~~Aug
15, 1994~No~RX~MYLAN PHARMACEUTICALS INC
CYSTEAMINE BITARTRATE~CAPSULE;ORAL~CYSTAGON~MYLAN~EQ 150MG BASE~N~020392~002~~Au
g 15, 1994~Yes~RX~MYLAN PHARMACEUTICALS INC
GANCICLOVIR~CAPSULE;ORAL~CYTOVENE~ROCHE PALO~250MG **Federal Register determinat
ion that product was not discontinued or withdrawn for safety or efficacy reason
s**~N~020460~001~~Dec 22, 1994~No~DISCN~ROCHE PALO ALTO LLC
GANCICLOVIR~CAPSULE;ORAL~CYTOVENE~ROCHE PALO~500MG **Federal Register determinat
s**~N~020460~002~~Dec 12, 1997~No~DISCN~ROCHE PALO ALTO LLC

FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~DALMANE~VALEANT PHARM INTL~15MG~N~016721~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~DALMANE~VALEANT PHARM INTL~30MG~N~016721~0
02~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
DANAZOL~CAPSULE;ORAL~DANAZOL~AM THERAP~200MG~A~071569~001~~Dec 30, 1987~No~DISCN
~AMERICAN THERAPEUTICS INC
DANAZOL~CAPSULE;ORAL~DANAZOL~BARR~50MG~A~074582~003~AB~May 29, 1998~No~RX~BARR L
ABORATORIES INC
DANAZOL~CAPSULE;ORAL~DANAZOL~BARR~100MG~A~074582~002~AB~May 29, 1998~No~RX~BARR
LABORATORIES INC
DANAZOL~CAPSULE;ORAL~DANAZOL~BARR~200MG~A~074582~001~AB~Aug 9, 1996~Yes~RX~BARR
LABORATORIES INC
DANAZOL~CAPSULE;ORAL~DANAZOL~LANNETT~50MG~A~078214~001~AB~Apr 19, 2007~No~RX~LAN
NETT HOLDINGS INC
DANAZOL~CAPSULE;ORAL~DANAZOL~LANNETT~100MG~A~078214~002~AB~Apr 19, 2007~No~RX~LA
NNETT HOLDINGS INC
DANAZOL~CAPSULE;ORAL~DANAZOL~LANNETT~200MG~A~077246~001~AB~Sep 28, 2005~No~RX~LA
NNETT HOLDINGS INC
DANAZOL~CAPSULE;ORAL~DANOCRINE~SANOFI AVENTIS US~50MG~N~017557~003~~Approved Pri
or to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
DANAZOL~CAPSULE;ORAL~DANOCRINE~SANOFI AVENTIS US~100MG~N~017557~004~~Approved Pr
ior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
DANAZOL~CAPSULE;ORAL~DANOCRINE~SANOFI AVENTIS US~200MG~N~017557~002~~Approved Pr
DANTROLENE SODIUM~CAPSULE;ORAL~DANTRIUM~PAR STERILE PRODUCTS~25MG~N~017443~001~A
B~Approved Prior to Jan 1, 1982~No~RX~PAR STERILE PRODUCTS LLC
DANTROLENE SODIUM~CAPSULE;ORAL~DANTRIUM~PAR STERILE PRODUCTS~50MG~N~017443~003~A
B~Approved Prior to Jan 1, 1982~No~RX~PAR STERILE PRODUCTS LLC
DANTROLENE SODIUM~CAPSULE;ORAL~DANTRIUM~PAR STERILE PRODUCTS~100MG~N~017443~002~
AB~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUCTS LLC
DANTROLENE SODIUM~CAPSULE;ORAL~DANTROLENE SODIUM~IMPAX LABS~25MG~A~076856~001~AB
~Mar 1, 2005~No~RX~IMPAX LABORATORIES INC
DANTROLENE SODIUM~CAPSULE;ORAL~DANTROLENE SODIUM~IMPAX LABS~50MG~A~076856~002~AB
~Mar 1, 2005~No~RX~IMPAX LABORATORIES INC
DANTROLENE SODIUM~CAPSULE;ORAL~DANTROLENE SODIUM~IMPAX LABS~100MG~A~076856~003~A
B~Mar 1, 2005~No~RX~IMPAX LABORATORIES INC
DANTROLENE SODIUM~CAPSULE;ORAL~DANTROLENE SODIUM~MIKAH PHARMA~25MG~A~076686~001~
AB~Oct 24, 2005~No~RX~MIKAH PHARMA LLC
DANTROLENE SODIUM~CAPSULE;ORAL~DANTROLENE SODIUM~MIKAH PHARMA~50MG~A~076686~002~
AB~Oct 24, 2005~No~RX~MIKAH PHARMA LLC
DANTROLENE SODIUM~CAPSULE;ORAL~DANTROLENE SODIUM~MIKAH PHARMA~100MG~A~076686~003
~AB~Oct 24, 2005~No~RX~MIKAH PHARMA LLC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~DARVON~XANODYNE PHARM~32MG~N~010997~001~
~Approved Prior to Jan 1, 1982~No~DISCN~XANODYNE PHARMACEUTICS INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~DARVON~XANODYNE PHARM~65MG~N~010997~003~
~Approved Prior to Jan 1, 1982~No~DISCN~XANODYNE PHARMACEUTICS INC
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~DARVON COMPOUND~XANOD
YNE PHARM~389MG;32.4MG;32MG~N~010996~006~~Mar 8, 1983~No~DISCN~XANODYNE PHARMACE
UTICS INC
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~DARVON COMPOUND-65~XA
NODYNE PHARM~389MG;32.4MG;65MG~N~010996~007~~Mar 8, 1983~No~DISCN~XANODYNE PHARM
ACEUTICS INC
ASPIRIN; PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~DARVON W/ ASA~XANODYNE PHARM~32
5MG;65MG~N~010996~005~~Approved Prior to Jan 1, 1982~No~DISCN~XANODYNE PHARMACEU
TICS INC
ASPIRIN; PROPOXYPHENE NAPSYLATE~CAPSULE;ORAL~DARVON-N W/ ASA~AAIPHARMA LLC~325MG
;100MG~N~016829~001~~Approved Prior to Jan 1, 1982~No~DISCN~AAIPHARMA LLC
DEMECLOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~DECLOMYCIN~LEDERLE~150MG~N~050262~001~
~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAM
ID CO
VITAMIN A PALMITATE~CAPSULE;ORAL~DEL-VI-A~DEL RAY LABS~EQ 50,000 UNITS BASE~A~08
0830~001~~Approved Prior to Jan 1, 1982~No~DISCN~DEL RAY LABORATORIES INC
AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHE
TAMINE SULFATE~CAPSULE;ORAL~DELCOBESE~TEVA~1.25MG;1.25MG;1.25MG;1.25MG **Federal
Register determination that product was not discontinued or withdrawn for safet
y or efficacy reasons**~A~083564~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEV
A PHARMACEUTICALS USA INC
TAMINE SULFATE~CAPSULE;ORAL~DELCOBESE~TEVA~2.5MG;2.5MG;2.5MG;2.5MG **Federal Reg
ister determination that product was not discontinued or withdrawn for safety or
efficacy reasons**~A~083564~002~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PH
TAMINE SULFATE~CAPSULE;ORAL~DELCOBESE~TEVA~3.75MG;3.75MG;3.75MG;3.75MG **Federal
y or efficacy reasons**~A~083564~003~~Approved Prior to Jan 1, 1982~No~DISCN~TEV
TAMINE SULFATE~CAPSULE;ORAL~DELCOBESE~TEVA~5MG;5MG;5MG;5MG **Federal Register de
termination that product was not discontinued or withdrawn for safety or efficac
y reasons**~A~083564~004~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUT
ICALS USA INC
ERGOCALCIFEROL~CAPSULE;ORAL~DELTALIN~LILLY~50,000 IU~A~080884~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
METYROSINE~CAPSULE;ORAL~DEMSER~ATON PHARMA VPNA~250MG~N~017871~001~~Approved Pri
or to Jan 1, 1982~Yes~RX~ATON PHARMA DIV VALEANT PHARMACEUTICALS NORTH AMERICA L
LC
VALPROIC ACID~CAPSULE;ORAL~DEPAKENE~ABBVIE~250MG~N~018081~001~AB~Approved Prior
to Jan 1, 1982~Yes~RX~ABBVIE INC
DEXTROAMPHETAMINE SULFATE~CAPSULE;ORAL~DEXAMPEX~TEVA~15MG~A~085355~001~~Approved
Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE~CAPSULE;ORAL~DHC PLUS~PHARM R
ES ASSOC~356.4MG;30MG;16MG~A~088584~001~~Mar 4, 1986~No~DISCN~PHARMACEUTICAL RES
EARCH ASSOC INC
PHENOXYBENZAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIBENZYLINE~COVIS PHARMA SARL~10MG~N
~008708~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~COVIS PHARMA SARL
DICLOXACILLIN SODIUM~CAPSULE;ORAL~DICLOXACILLIN SODIUM~SANDOZ~EQ 125MG BASE~A~06
1454~002~~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
1454~001~AB~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
1454~003~AB~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
DICLOXACILLIN SODIUM~CAPSULE;ORAL~DICLOXACILLIN SODIUM~TEVA~EQ 250MG BASE~A~0622
86~001~AB~Jun 3, 1982~No~RX~TEVA PHARMACEUTICALS USA INC
DICLOXACILLIN SODIUM~CAPSULE;ORAL~DICLOXACILLIN SODIUM~TEVA~EQ 500MG BASE~A~0622
86~002~AB~Jun 3, 1982~No~RX~TEVA PHARMACEUTICALS USA INC
DICUMAROL~CAPSULE;ORAL~DICUMAROL~LILLY~25MG~N~005509~003~~Approved Prior to Jan
1, 1982~No~DISCN~ELI LILLY AND CO
DICUMAROL~CAPSULE;ORAL~DICUMAROL~LILLY~50MG~N~005509~001~~Approved Prior to Jan
DICYCLOMINE HYDROCHLORIDE~CAPSULE;ORAL~DICYCLOMINE HYDROCHLORIDE~HIKMA PHARMS LL
C~10MG~A~040204~001~~Feb 28, 1997~No~DISCN~HIKMA PHARMACEUTICALS LLC
DICYCLOMINE HYDROCHLORIDE~CAPSULE;ORAL~DICYCLOMINE HYDROCHLORIDE~LANNETT~10MG~A~
084285~001~AB~Approved Prior to Jan 1, 1982~No~RX~LANNETT CO INC
DICYCLOMINE HYDROCHLORIDE~CAPSULE;ORAL~DICYCLOMINE HYDROCHLORIDE~MUTUAL PHARM~10
MG~A~084505~001~~Oct 21, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DICYCLOMINE HYDROCHLORIDE~CAPSULE;ORAL~DICYCLOMINE HYDROCHLORIDE~MYLAN~10MG~A~04
0319~001~AB~Sep 7, 1999~No~RX~MYLAN PHARMACEUTICALS INC
DICYCLOMINE HYDROCHLORIDE~CAPSULE;ORAL~DICYCLOMINE HYDROCHLORIDE~PIONEER PHARMS~
10MG~A~089361~001~~Jan 10, 1989~No~DISCN~PIONEER PHARMACEUTICALS INC

DICYCLOMINE HYDROCHLORIDE~CAPSULE;ORAL~DICYCLOMINE HYDROCHLORIDE~WATSON LABS~10M
G~A~083179~001~~Feb 12, 1986~No~DISCN~WATSON LABORATORIES INC
DICYCLOMINE HYDROCHLORIDE~CAPSULE;ORAL~DICYCLOMINE HYDROCHLORIDE~WATSON LABS~10M
G~A~085082~001~AB~Jun 19, 1986~No~RX~WATSON LABORATORIES INC
PHENYTOIN SODIUM~CAPSULE;ORAL~DILANTIN~PARKE DAVIS~30MG EXTENDED~A~084349~001~AB
~Approved Prior to Jan 1, 1982~Yes~RX~PARKE DAVIS DIV WARNER LAMBERT CO
PHENYTOIN SODIUM~CAPSULE;ORAL~DILANTIN~PARKE DAVIS~100MG EXTENDED~A~084349~002~A
B~Approved Prior to Jan 1, 1982~Yes~RX~PARKE DAVIS DIV WARNER LAMBERT CO
VALSARTAN~CAPSULE;ORAL~DIOVAN~NOVARTIS~80MG~N~020665~001~~Dec 23, 1996~No~DISCN~
NOVARTIS PHARMACEUTICALS CORP
VALSARTAN~CAPSULE;ORAL~DIOVAN~NOVARTIS~160MG~N~020665~002~~Dec 23, 1996~No~DISCN
~NOVARTIS PHARMACEUTICALS CORP
OLSALAZINE SODIUM~CAPSULE;ORAL~DIPENTUM~MEDA PHARMS~250MG~N~019715~001~~Jul 31,
1990~Yes~RX~MEDA PHARMACEUTICALS INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~ALRA~25
MG~A~080519~004~~Approved Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~ALRA~50
MG~A~080519~003~~Approved Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~ANABOLI
C~50MG~A~083275~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANABOLIC INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~BARR~50
MG~A~080738~001~~Approved Prior to Jan 1, 1982~Yes~RX~BARR LABORATORIES INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~ELKINS
SINN~25MG~A~085701~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV A
H ROBINS CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~ELKINS
SINN~50MG~A~085701~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV A
H ROBINS CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~HALSEY~
50MG~A~087914~001~~Jun 4, 1984~No~DISCN~HALSEY DRUG CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~HEATHER
~25MG~A~084524~001~~Approved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~HEATHER
~50MG~A~083953~001~~Approved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~HIKMA P
HARMS LLC~50MG~A~083567~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHARMA
CEUTICALS LLC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~IMPAX L
ABS~25MG~A~080807~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES
INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~IMPAX L
ABS~50MG~A~080807~002~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES
INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~IVAX SU
B TEVA PHARMS~25MG~A~080762~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHA
RMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~IVAX SU
B TEVA PHARMS~50MG~A~080762~002~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHA
RMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LANNETT
~25MG~A~080868~001~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LANNETT
~50MG~A~080868~002~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LEDERLE
~25MG~A~086874~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LEDERLE
~50MG~A~086875~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LNK~25M

G~A~087977~001~~Jan 27, 1983~No~DISCN~LNK INTERNATIONAL INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LNK~50M
G~A~087978~001~~Jan 27, 1983~No~DISCN~LNK INTERNATIONAL INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~MK LABS
~25MG~A~083087~001~~Approved Prior to Jan 1, 1982~No~DISCN~MK LABORATORIES INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~MK LABS
~50MG~A~083087~002~~Approved Prior to Jan 1, 1982~No~DISCN~MK LABORATORIES INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~MUTUAL
PHARM~25MG~A~084506~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEU
TICAL CO INC
PHARM~25MG~A~089488~001~~Jan 2, 1987~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
PHARM~50MG~A~089489~001~~Jan 2, 1987~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~NEWTRON
PHARMS~25MG~A~086543~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEWTRON PHARMA
CEUTICALS INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~NEWTRON
PHARMS~50MG~A~086544~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEWTRON PHARMA
CEUTICALS INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~NEXGEN
PHARMA INC~25MG~A~083634~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEXGEN PHAR
MA INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PERRIGO
~25MG~A~083061~001~~Approved Prior to Jan 1, 1982~No~DISCN~L PERRIGO CO
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PERRIGO
~50MG~A~083061~002~~Approved Prior to Jan 1, 1982~No~DISCN~L PERRIGO CO
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PIONEER
PHARMS~25MG~A~089101~001~~Dec 20, 1985~No~DISCN~PIONEER PHARMACEUTICALS INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PIONEER
PHARMS~50MG~A~088880~001~~Dec 20, 1985~No~DISCN~PIONEER PHARMACEUTICALS INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PUREPAC
PHARM~25MG~A~085156~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMAC
EUTICAL CO
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PUREPAC
PHARM~50MG~A~085150~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMAC
EUTICAL CO
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PVT FOR
M~25MG~A~083027~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS
INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PVT FOR
M~50MG~A~083027~002~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS
INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~ROXANE~
50MG~A~080635~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES IN
C
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~SANDOZ~
25MG~A~080832~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~SUPERPH
ARM~25MG~A~089040~001~~May 15, 1985~No~DISCN~SUPERPHARM CORP
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~SUPERPH
ARM~50MG~A~089041~001~~May 15, 1985~No~DISCN~SUPERPHARM CORP
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~TEVA~25
MG~A~085874~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA

INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~TEVA~50
MG~A~085874~002~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA
INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~VALEANT
PHARM INTL~25MG~A~080596~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PH
ARMACEUTICALS INTERNATIONAL
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~VALEANT
PHARM INTL~50MG~A~080592~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PH
ARMACEUTICALS INTERNATIONAL
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~VANGARD
~25MG~A~088034~001~~Oct 27, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY ME
DICAL CO
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~VANGARD
~50MG~A~087630~001~~Approved Prior to Jan 1, 1982~No~DISCN~VANGARD LABORATORIES
INC DIV MIDWAY MEDICAL CO
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~WATSON
LABS~25MG~A~080728~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORI
ES INC
ES INC
ES INC
ES INC
ES INC
ES INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~WHITEWO
RTH TOWN PLSN~25MG~A~083441~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWOR
TH TOWNE PAULSEN INC
DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~WHITEWO
RTH TOWN PLSN~50MG~A~080800~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWOR
TH TOWNE PAULSEN INC
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENOXYLATE HYDROCH
LORIDE W/ ATROPINE SULFATE~SCHERER RP~0.025MG;2.5MG~A~086440~001~~Approved Prior
to Jan 1, 1982~No~DISCN~RP SCHERER NORTH AMERICA DIV RP SCHERER CORP
PHENYTOIN SODIUM~CAPSULE;ORAL~DIPHENYLAN SODIUM~LANNETT~30MG PROMPT~A~080857~001
~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
PHENYTOIN SODIUM~CAPSULE;ORAL~DIPHENYLAN SODIUM~LANNETT~100MG PROMPT~A~080857~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~INTERPHARM~EQ 100MG B
ASE~A~071190~001~~Jan 15, 1987~No~DISCN~INTERPHARM INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~INTERPHARM~EQ 150MG B
ASE~A~071191~001~~Jan 15, 1987~No~DISCN~INTERPHARM INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~IVAX SUB TEVA PHARMS~
EQ 100MG BASE~A~070186~001~~Nov 18, 1985~No~DISCN~IVAX PHARMACEUTICALS INC SUB T
EVA PHARMACEUTICALS USA
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~IVAX SUB TEVA PHARMS~
EQ 150MG BASE~A~070187~001~~Nov 18, 1985~No~DISCN~IVAX PHARMACEUTICALS INC SUB T
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~MUTUAL PHARM~EQ 100MG
BASE~A~070351~001~~Dec 17, 1985~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~MUTUAL PHARM~EQ 150MG

BASE~A~070352~001~~Dec 17, 1985~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~MYLAN~EQ 100MG BASE~A
~070138~001~~Jun 14, 1985~No~DISCN~MYLAN PHARMACEUTICALS INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~MYLAN~EQ 150MG BASE~A
~070139~001~~Jun 14, 1985~No~DISCN~MYLAN PHARMACEUTICALS INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~SANDOZ~EQ 100MG BASE~
A~070470~001~~Dec 10, 1985~No~DISCN~SANDOZ INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~SANDOZ~EQ 150MG BASE~
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~SUPERPHARM~EQ 100MG B
ASE~A~070940~001~~Feb 9, 1987~No~DISCN~SUPERPHARM CORP
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~SUPERPHARM~EQ 150MG B
ASE~A~070941~001~~Feb 9, 1987~No~DISCN~SUPERPHARM CORP
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~TEVA~EQ 100MG BASE~A~
070101~001~AB~Feb 22, 1985~No~RX~TEVA PHARMACEUTICALS USA INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~TEVA~EQ 150MG BASE~A~
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~WATSON LABS~EQ 100MG
BASE~A~070173~001~AB~May 31, 1985~No~RX~WATSON LABORATORIES INC
BASE~A~070240~001~~Feb 2, 1986~No~DISCN~WATSON LABORATORIES INC
BASE~A~070174~001~AB~May 31, 1985~No~RX~WATSON LABORATORIES INC
BASE~A~070241~001~~Feb 2, 1986~No~DISCN~WATSON LABORATORIES INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~DOLENE~HERITAGE PHARMS INC~65MG~A~080530
~001~~Approved Prior to Jan 1, 1982~No~DISCN~HERITAGE PHARMACEUTICALS INC
LEVODOPA~CAPSULE;ORAL~DOPAR~SHIRE~100MG~N~016913~003~~Approved Prior to Jan 1, 1
982~No~DISCN~SHIRE DEVELOPMENT INC
GLUTETHIMIDE~CAPSULE;ORAL~DORIDEN~SANOFI AVENTIS US~500MG~N~009519~008~~Approved
Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~DAVA PHARMS INC~EQ 10MG
BASE~A~071685~001~~Jan 5, 1988~No~DISCN~DAVA PHARMACEUTICALS INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~DAVA PHARMS INC~EQ 100M
G BASE~A~071675~001~~Jan 5, 1988~No~DISCN~DAVA PHARMACEUTICALS INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~DAVA PHARMS INC~EQ 150M
G BASE~A~071676~001~~Jan 5, 1988~No~DISCN~DAVA PHARMACEUTICALS INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~MUTUAL PHARM~EQ 25MG BA
SE~A~071502~001~~Feb 18, 1988~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~MUTUAL PHARM~EQ 100MG B
ASE~A~071521~001~~Feb 18, 1988~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~MYLAN PHARMS INC~EQ 10M
G BASE~A~070791~002~AB~May 13, 1986~No~RX~MYLAN PHARMACEUTICALS INC
G BASE~A~070791~003~AB~May 13, 1986~Yes~RX~MYLAN PHARMACEUTICALS INC

DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~MYLAN PHARMS INC~EQ 100
MG BASE~A~070791~005~AB~May 13, 1986~Yes~RX~MYLAN PHARMACEUTICALS INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~NEW RIVER~EQ 10MG BASE~
N~016987~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEW RIVER PHARMACEUTICALS I
NC
NC
NC
NC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~NEW RIVER~EQ 100MG BASE
~N~016987~004~~Approved Prior to Jan 1, 1982~No~DISCN~NEW RIVER PHARMACEUTICALS
INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~NEW RIVER~EQ 150MG BASE
~N~016987~007~~Apr 13, 1987~No~DISCN~NEW RIVER PHARMACEUTICALS INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~PAR PHARM~EQ 10MG BASE~
A~071697~001~~Nov 9, 1987~No~DISCN~PAR PHARMACEUTICAL INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~PAR PHARM~EQ 100MG BASE
~A~071422~001~~Nov 9, 1987~No~DISCN~PAR PHARMACEUTICAL INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~PAR PHARM~EQ 150MG BASE
~A~071669~001~~Nov 9, 1987~Yes~RX~PAR PHARMACEUTICAL INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~PUREPAC PHARM~EQ 10MG B
ASE~A~073054~001~~Dec 28, 1990~No~DISCN~PUREPAC PHARMACEUTICAL CO
ASE~A~072386~001~~Sep 8, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~PUREPAC PHARM~EQ 100MG
BASE~A~072110~001~~Sep 8, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~PUREPAC PHARM~EQ 150MG
BASE~A~072387~001~~Sep 8, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~QUANTUM PHARMICS~EQ 10M
G BASE~A~070972~001~~Sep 29, 1987~No~DISCN~QUANTUM PHARMICS LTD
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~QUANTUM PHARMICS~EQ 100
MG BASE~A~072375~001~~Mar 15, 1989~No~DISCN~QUANTUM PHARMICS LTD
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~QUANTUM PHARMICS~EQ 150
MG BASE~A~072376~001~~Mar 15, 1989~No~DISCN~QUANTUM PHARMICS LTD
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~SANDOZ~EQ 10MG BASE~A~0
71487~001~~Mar 2, 1987~No~DISCN~SANDOZ INC

70827~001~~May 15, 1986~No~DISCN~SANDOZ INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~SANDOZ~EQ 100MG BASE~A~
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~WATSON LABS~EQ 10MG BAS
E~A~070952~001~~Mar 4, 1987~No~DISCN~WATSON LABORATORIES INC
E~A~071485~001~~Apr 30, 1987~No~DISCN~WATSON LABORATORIES INC
E~A~070953~001~~May 15, 1986~No~DISCN~WATSON LABORATORIES INC
E~A~070954~001~~May 15, 1986~No~DISCN~WATSON LABORATORIES INC
E~A~071763~001~~Feb 9, 1988~No~DISCN~WATSON LABORATORIES INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~WATSON LABS~EQ 100MG BA
SE~A~070955~001~~May 15, 1986~No~DISCN~WATSON LABORATORIES INC
SE~A~071239~001~~Apr 30, 1987~No~DISCN~WATSON LABORATORIES INC
SE~A~071764~001~~Feb 9, 1988~No~DISCN~WATSON LABORATORIES INC
DOXERCALCIFEROL~CAPSULE;ORAL~DOXERCALCIFEROL~ROXANE~0.5MCG~A~091433~001~AB~Sep 2
3, 2011~No~RX~ROXANE LABORATORIES INC
DOXERCALCIFEROL~CAPSULE;ORAL~DOXERCALCIFEROL~ROXANE~1MCG~A~091433~002~AB~Jan 14,
DOXERCALCIFEROL~CAPSULE;ORAL~DOXERCALCIFEROL~ROXANE~2.5MCG~A~091433~003~AB~Jan 1
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXY-LEMMON~TEVA~EQ 50MG BASE~A~062497~001~~Aug
23, 1984~No~DISCN~TEVA PHARMACEUTICALS USA INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXY-LEMMON~TEVA~EQ 100MG BASE~A~062497~002~~Ju
n 15, 1984~No~DISCN~TEVA PHARMACEUTICALS USA INC
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~IMPAX LABS INC~EQ 150MG BASE~A~200065~001~A
B~Feb 17, 2011~No~RX~IMPAX LABORATORIES INC
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~LUPIN LTD~EQ 50MG BASE~A~204234~001~AB~Mar
5, 2014~No~RX~LUPIN LTD
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~MYLAN PHARMS INC~EQ 150MG BASE~A~202778~001
~AB~Jun 8, 2012~No~RX~MYLAN PHARMACEUTICALS INC
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~PAR PHARM~EQ 50MG BASE~A~065055~001~AB~Dec
1, 2000~No~RX~PAR PHARMACEUTICAL INC
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~PAR PHARM~EQ 75MG BASE~A~065055~004~~Apr 18
, 2005~No~DISCN~PAR PHARMACEUTICAL INC

DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~PAR PHARM~EQ 100MG BASE~A~065055~002~AB~Dec
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~PAR PHARM~EQ 150MG BASE~A~065055~003~AB~Jul
15, 2005~Yes~RX~PAR PHARMACEUTICAL INC
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~RANBAXY~EQ 50MG BASE~A~065053~001~AB~Nov 22
, 2000~No~RX~RANBAXY LABORATORIES LTD
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~RANBAXY~EQ 75MG BASE~A~065053~003~AB~Sep 10
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~RANBAXY~EQ 100MG BASE~A~065053~002~AB~Nov 2
2, 2000~No~RX~RANBAXY LABORATORIES LTD
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~SANDOZ INC~EQ 50MG BASE~A~065032~001~~Jun 3
0, 2000~No~DISCN~SANDOZ INC
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~SANDOZ INC~EQ 100MG BASE~A~065032~002~~Jun
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~WATSON LABS~EQ 50MG BASE~A~065041~001~~Apr
DOXYCYCLINE~CAPSULE;ORAL~DOXYCYCLINE~WATSON LABS~EQ 100MG BASE~A~065041~002~~Apr
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~ACTAVIS LABS FL INC~EQ 50MG
BASE~A~062031~002~AB~Oct 13, 1982~No~RX~ACTAVIS LABORATORIES FL INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~ACTAVIS LABS FL INC~EQ 100M
G BASE~A~062031~001~AB~Approved Prior to Jan 1, 1982~No~RX~ACTAVIS LABORATORIES
FL INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~CHARTWELL LIFE SCI~EQ 50MG
BASE~A~062500~001~AB~Sep 11, 1984~No~RX~CHARTWELL LIFE SCIENCE LLC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~CHARTWELL LIFE SCI~EQ 100MG
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~HALSEY~EQ 50MG BASE~A~06211
9~002~~May 24, 1985~No~DISCN~HALSEY DRUG CO INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~HALSEY~EQ 100MG BASE~A~0621
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~HEATHER~EQ 50MG BASE~A~0624
63~001~~Dec 7, 1983~No~DISCN~HEATHER DRUG CO INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~HEATHER~EQ 100MG BASE~A~062
463~002~~Dec 7, 1983~No~DISCN~HEATHER DRUG CO INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~HIKMA INTL PHARMS~EQ 20MG B
ASE~A~065103~001~~May 13, 2005~Yes~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~HIKMA INTL PHARMS~EQ 50MG B
ASE~A~062396~002~AB~Nov 7, 1984~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~HIKMA INTL PHARMS~EQ 100MG
BASE~A~062396~001~AB~May 7, 1984~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~INTERPHARM~EQ 50MG BASE~A~0
62763~001~~Sep 2, 1988~No~DISCN~INTERPHARM INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~INTERPHARM~EQ 100MG BASE~A~
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~MUTUAL PHARM~EQ 50MG BASE~A
~062418~001~~Jan 28, 1983~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~MUTUAL PHARM~EQ 50MG BASE~A
~062675~001~AB~Jul 10, 1986~No~RX~MUTUAL PHARMACEUTICAL CO INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~MUTUAL PHARM~EQ 100MG BASE~
A~062418~002~~Jan 28, 1983~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~MUTUAL PHARM~EQ 100MG BASE~
A~062676~001~AB~Jul 10, 1986~No~RX~MUTUAL PHARMACEUTICAL CO INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~MYLAN~EQ 50MG BASE~A~062337
~001~AB~Mar 29, 1982~No~RX~MYLAN PHARMACEUTICALS INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~MYLAN~EQ 100MG BASE~A~06233
7~002~AB~Mar 29, 1982~No~RX~MYLAN PHARMACEUTICALS INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~PAR PHARM~EQ 50MG BASE~A~06
2434~001~~Oct 19, 1984~No~DISCN~PAR PHARMACEUTICAL INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~PAR PHARM~EQ 100MG BASE~A~0

62442~001~~Dec 22, 1983~No~DISCN~PAR PHARMACEUTICAL INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~PVT FORM~EQ 50MG BASE~A~062
631~001~~Jul 24, 1986~No~DISCN~PRIVATE FORMULATIONS INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~PVT FORM~EQ 100MG BASE~A~06
2631~002~~Jul 24, 1986~No~DISCN~PRIVATE FORMULATIONS INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~RANBAXY~EQ 50MG BASE~A~0624
79~001~~Dec 23, 1983~No~DISCN~RANBAXY PHARMACEUTICALS INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~RANBAXY~EQ 100MG BASE~A~062
479~002~~Dec 23, 1983~No~DISCN~RANBAXY PHARMACEUTICALS INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~SUPERPHARM~EQ 50MG BASE~A~0
62469~001~~Oct 31, 1984~No~DISCN~SUPERPHARM CORP
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~SUPERPHARM~EQ 100MG BASE~A~
062469~002~~Oct 31, 1984~No~DISCN~SUPERPHARM CORP
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~WARNER CHILCOTT~EQ 50MG BAS
E~A~062594~001~~Dec 5, 1985~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~WARNER CHILCOTT~EQ 100MG BA
SE~A~062594~002~~Dec 5, 1985~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~WATSON LABS~EQ 50MG BASE~A~
061717~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~WATSON LABS~EQ 50MG BASE~A~
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~WATSON LABS~EQ 100MG BASE~A
~061717~002~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~DOXYCYCLINE HYCLATE~WATSON LABS~EQ 100MG BASE~A
ERGOCALCIFEROL~CAPSULE;ORAL~DRISDOL~SANOFI AVENTIS US~50,000 IU~N~003444~001~AA~
Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
DRONABINOL~CAPSULE;ORAL~DRONABINOL~AKORN INC~2.5MG~A~079217~001~AB~Jun 20, 2014~
No~RX~AKORN INC
DRONABINOL~CAPSULE;ORAL~DRONABINOL~AKORN INC~5MG~A~079217~002~AB~Jun 20, 2014~No
~RX~AKORN INC
DRONABINOL~CAPSULE;ORAL~DRONABINOL~AKORN INC~10MG~A~079217~003~AB~Jun 20, 2014~N
o~RX~AKORN INC
DRONABINOL~CAPSULE;ORAL~DRONABINOL~INSYS THERAP~2.5MG~A~078501~001~AB~Aug 19, 20
11~No~RX~INSYS THERAPEUTICS INC
DRONABINOL~CAPSULE;ORAL~DRONABINOL~INSYS THERAP~5MG~A~078501~002~AB~Aug 19, 2011
~No~RX~INSYS THERAPEUTICS INC
DRONABINOL~CAPSULE;ORAL~DRONABINOL~INSYS THERAP~10MG~A~078501~003~AB~Aug 19, 201
1~No~RX~INSYS THERAPEUTICS INC
DRONABINOL~CAPSULE;ORAL~DRONABINOL~SVC PHARMA~2.5MG~A~078292~001~AB~Jun 27, 2008
~No~RX~SVC PHARMA LP
DRONABINOL~CAPSULE;ORAL~DRONABINOL~SVC PHARMA~5MG~A~078292~002~AB~Jun 27, 2008~N
o~RX~SVC PHARMA LP
DRONABINOL~CAPSULE;ORAL~DRONABINOL~SVC PHARMA~10MG~A~078292~003~AB~Jun 27, 2008~
No~RX~SVC PHARMA LP
HYDROXYUREA~CAPSULE;ORAL~DROXIA~BRISTOL MYERS SQUIBB~200MG~N~016295~002~~Feb 25,
1998~No~RX~BRISTOL MYERS SQUIBB CO
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~DURICEF~WARNER CHILCOTT~EQ 250MG
BASE~N~050512~002~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT INC
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~DURICEF~WARNER CHILCOTT~EQ 500MG
BASE~N~050512~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT INC
DUTASTERIDE~CAPSULE;ORAL~DUTASTERIDE~BARR~0.5MG~A~090095~001~AB~Dec 21, 2010~No~
RX~BARR LABORATORIES INC
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~DUTASTERIDE AND TAMSULOSIN HY
DROCHLORIDE~ANCHEN PHARMS~0.5MG;0.4MG~A~202509~001~AB~Feb 26, 2014~No~RX~ANCHEN
PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; TRIAMTERENE~CAPSULE;ORAL~DYAZIDE~GLAXOSMITHKLINE LLC~25MG;3
7.5MG~N~016042~003~AB~Mar 3, 1994~Yes~RX~GLAXOSMITHKLINE LLC
HYDROCHLOROTHIAZIDE; TRIAMTERENE~CAPSULE;ORAL~DYAZIDE~GLAXOSMITHKLINE LLC~25MG;5
0MG~N~016042~002~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE LLC
DICLOXACILLIN SODIUM~CAPSULE;ORAL~DYCILL~GLAXOSMITHKLINE~EQ 250MG BASE~A~060254~
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~DYNACIN~CNTY LINE PHARMS~EQ 50MG BASE~A~0
63066~001~~Aug 14, 1990~No~DISCN~COUNTY LINE PHARMACEUTICALS LLC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~DYNACIN~CNTY LINE PHARMS~EQ 75MG BASE~A~0
63067~002~AB~Sep 15, 1999~No~RX~COUNTY LINE PHARMACEUTICALS LLC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~DYNACIN~CNTY LINE PHARMS~EQ 100MG BASE~A~
063067~001~AB~Jul 31, 1990~No~RX~COUNTY LINE PHARMACEUTICALS LLC
ISRADIPINE~CAPSULE;ORAL~DYNACIRC~SMITHKLINE BEECHAM~2.5MG~N~019546~001~~Dec 20,
1990~No~DISCN~SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
ISRADIPINE~CAPSULE;ORAL~DYNACIRC~SMITHKLINE BEECHAM~5MG~N~019546~002~~Dec 20, 19
TRIAMTERENE~CAPSULE;ORAL~DYRENIUM~COVIS PHARMA SARL~50MG~N~013174~001~~Approved
Prior to Jan 1, 1982~No~RX~COVIS PHARMA SARL
TRIAMTERENE~CAPSULE;ORAL~DYRENIUM~COVIS PHARMA SARL~100MG~N~013174~002~~Approved
Prior to Jan 1, 1982~Yes~RX~COVIS PHARMA SARL
SELEGILINE HYDROCHLORIDE~CAPSULE;ORAL~ELDEPRYL~SOMERSET~5MG~N~020647~001~AB~May
15, 1996~Yes~RX~SOMERSET PHARMACEUTICALS INC
THEOPHYLLINE~CAPSULE;ORAL~ELIXOPHYLLIN~FOREST LABS~100MG~A~085545~001~~Jul 31, 1
984~No~DISCN~FOREST LABORATORIES INC
THEOPHYLLINE~CAPSULE;ORAL~ELIXOPHYLLIN~FOREST LABS~200MG~A~083921~001~~Jul 31, 1
PENTOSAN POLYSULFATE SODIUM~CAPSULE;ORAL~ELMIRON~JANSSEN PHARMS~100MG~N~020193~0
01~~Sep 26, 1996~Yes~RX~JANSSEN PHARMACEUTICALS INC
ESTRAMUSTINE PHOSPHATE SODIUM~CAPSULE;ORAL~EMCYT~PHARMACIA AND UPJOHN~EQ 140MG P
HOSPHATE~N~018045~001~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN
CO
APREPITANT~CAPSULE;ORAL~EMEND~MERCK~40MG~N~021549~003~AB~Jun 30, 2006~No~RX~MERC
K AND CO INC
APREPITANT~CAPSULE;ORAL~EMEND~MERCK~80MG~N~021549~001~AB~Mar 26, 2003~No~RX~MERC
K AND CO INC
APREPITANT~CAPSULE;ORAL~EMEND~MERCK~125MG~N~021549~002~AB~Mar 26, 2003~Yes~RX~ME
RCK AND CO INC
EMTRICITABINE~CAPSULE;ORAL~EMTRIVA~GILEAD~200MG~N~021500~001~~Jul 2, 2003~Yes~RX
~GILEAD SCIENCES INC
ALVIMOPAN~CAPSULE;ORAL~ENTEREG~CUBIST PHARMS~12MG~N~021775~001~~May 20, 2008~Yes
~RX~CUBIST PHARMACEUTICALS INC
BUDESONIDE~CAPSULE;ORAL~ENTOCORT EC~ASTRAZENECA~3MG~N~021324~001~AB~Oct 2, 2001~
Yes~RX~ASTRAZENECA LP
OMEGA-3-CARBOXYLIC ACIDS~CAPSULE;ORAL~EPANOVA~ASTRAZENECA PHARMS~1GM CONTAINS AT
LEAST 850MG OF POLYUNSATURATED FATTY ACIDS~N~205060~001~~May 5, 2014~Yes~RX~AST
RAZENECA PHARMACEUTICALS LP
MEPROBAMATE~CAPSULE;ORAL~EQUANIL~WYETH AYERST~400MG~N~012455~002~~Approved Prior
to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
ERGOCALCIFEROL~CAPSULE;ORAL~ERGOCALCIFEROL~ORIT LABS LLC~50,000 IU~A~040833~001~
AA~May 20, 2009~No~RX~ORIT LABORATORIES LLC
ERGOCALCIFEROL~CAPSULE;ORAL~ERGOCALCIFEROL~SIGMAPHARM LABS LLC~50,000 IU~A~09100
4~001~AA~Jul 14, 2010~No~RX~SIGMAPHARM LABORATORIES LLC
ERGOCALCIFEROL~CAPSULE;ORAL~ERGOCALCIFEROL~STRIDES PHARMA~50,000 IU~A~090455~001
~AA~Aug 3, 2010~No~RX~STRIDES PHARMA GLOBAL PTE LTD

ERGOCALCIFEROL~CAPSULE;ORAL~ERGOCALCIFEROL~SUN PHARM INDS INC~50,000 IU~A~040865
~001~AA~Dec 29, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
VISMODEGIB~CAPSULE;ORAL~ERIVEDGE~GENENTECH~150MG~N~203388~001~~Jan 30, 2012~Yes~
RX~GENENTECH INC
ERYTHROMYCIN ESTOLATE~CAPSULE;ORAL~ERYTHROMYCIN ESTOLATE~BARR~EQ 125MG BASE~A~06
2162~001~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
ERYTHROMYCIN ESTOLATE~CAPSULE;ORAL~ERYTHROMYCIN ESTOLATE~BARR~EQ 250MG BASE~A~06
2162~002~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
ERYTHROMYCIN ESTOLATE~CAPSULE;ORAL~ERYTHROMYCIN ESTOLATE~IVAX SUB TEVA PHARMS~EQ
250MG BASE~A~062237~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUT
ICALS INC SUB TEVA PHARMACEUTICALS USA
ERYTHROMYCIN ESTOLATE~CAPSULE;ORAL~ERYTHROMYCIN ESTOLATE~WATSON LABS~EQ 250MG BA
SE~A~062087~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
PIRFENIDONE~CAPSULE;ORAL~ESBRIET~GENENTECH INC~267MG~N~022535~001~~Oct 15, 2014~
Yes~RX~GENENTECH INC
ESCITALOPRAM OXALATE~CAPSULE;ORAL~ESCITALOPRAM OXALATE~MYLAN PHARMS INC~EQ 5MG B
ASE~A~077660~001~~Jul 31, 2007~No~DISCN~MYLAN PHARMACEUTICALS INC
ESCITALOPRAM OXALATE~CAPSULE;ORAL~ESCITALOPRAM OXALATE~MYLAN PHARMS INC~EQ 10MG
BASE~A~077660~002~~Jul 31, 2007~No~DISCN~MYLAN PHARMACEUTICALS INC
ESCITALOPRAM OXALATE~CAPSULE;ORAL~ESCITALOPRAM OXALATE~MYLAN PHARMS INC~EQ 20MG
BASE~A~077660~003~~Jul 31, 2007~No~DISCN~MYLAN PHARMACEUTICALS INC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~ESGIC-PLUS~MIKART~500MG;50MG;40
MG~A~040085~001~~Mar 28, 1996~No~DISCN~MIKART INC
LITHIUM CARBONATE~CAPSULE;ORAL~ESKALITH~NOVEN THERAP~300MG~N~016860~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~NOVEN THERAPEUTICS LLC
ETHCHLORVYNOL~CAPSULE;ORAL~ETHCHLORVYNOL~BANNER PHARMACAPS~100MG~A~084463~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~BANNER PHARMACAPS INC
ETHOSUXIMIDE~CAPSULE;ORAL~ETHOSUXIMIDE~BANNER LIFE SCIENCES~250MG~A~040430~001~A
B~Oct 28, 2002~No~RX~BANNER LIFE SCIENCES LLC
ETHOSUXIMIDE~CAPSULE;ORAL~ETHOSUXIMIDE~VERSAPHARM~250MG~A~040686~001~AB~May 28,
2008~No~RX~VERSAPHARM INC
ETHOSUXIMIDE~CAPSULE;ORAL~ETHOSUXIMIDE~ZYDUS PHARMS USA INC~250MG~A~200892~001~A
B~Sep 25, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~AAIPHARMA LLC~300MG~A~074929~001~~Jan 30, 1998~No
~DISCN~AAIPHARMA LLC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~ANI PHARMS INC~200MG~A~074899~001~~Jul 8, 1997~No
~DISCN~ANI PHARMACEUTICALS INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~ANI PHARMS INC~200MG~A~075126~001~AB~Sep 16, 1999
~No~RX~ANI PHARMACEUTICALS INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~ANI PHARMS INC~300MG~A~074899~002~~Jul 8, 1997~No
~DISCN~ANI PHARMACEUTICALS INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~ANI PHARMS INC~300MG~A~075126~002~AB~Sep 16, 1999
~No~RX~ANI PHARMACEUTICALS INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~APOTEX~200MG~A~075419~001~AB~Jul 28, 2000~No~RX~A
POTEX INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~APOTEX~300MG~A~075419~002~AB~Jul 28, 2000~No~RX~A
POTEX INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~MYLAN~200MG~A~074932~001~~May 16, 1997~No~DISCN~M
YLAN PHARMACEUTICALS INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~MYLAN~200MG~A~075071~001~~Sep 30, 1998~No~DISCN~M
ETODOLAC~CAPSULE;ORAL~ETODOLAC~MYLAN~300MG~A~074932~002~~May 16, 1997~No~DISCN~M
ETODOLAC~CAPSULE;ORAL~ETODOLAC~MYLAN~300MG~A~075071~002~~Sep 30, 1998~No~DISCN~M

ETODOLAC~CAPSULE;ORAL~ETODOLAC~SANDOZ~200MG~A~074840~001~~Aug 29, 1997~No~DISCN~
SANDOZ INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~SANDOZ~200MG~A~074942~001~~Sep 30, 1997~No~DISCN~
SANDOZ INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~SANDOZ~300MG~A~074840~002~~Aug 29, 1997~No~DISCN~
SANDOZ INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~SANDOZ~300MG~A~074942~002~~Sep 30, 1997~No~DISCN~
SANDOZ INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~TARO~200MG~A~075078~001~AB~Apr 30, 1998~No~RX~TAR
O PHARMACEUTICAL INDUSTRIES LTD
ETODOLAC~CAPSULE;ORAL~ETODOLAC~TARO~300MG~A~075078~002~AB~Apr 30, 1998~Yes~RX~TA
RO PHARMACEUTICAL INDUSTRIES LTD
ETODOLAC~CAPSULE;ORAL~ETODOLAC~VINTAGE PHARMS LLC~200MG~A~074842~001~~Jul 17, 19
97~No~DISCN~VINTAGE PHARMACEUTICALS LLC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~VINTAGE PHARMS LLC~300MG~A~074842~002~~Jul 17, 19
ETODOLAC~CAPSULE;ORAL~ETODOLAC~WATSON LABS~200MG~A~074844~001~~Dec 23, 1997~No~D
ISCN~WATSON LABORATORIES INC
ETODOLAC~CAPSULE;ORAL~ETODOLAC~WATSON LABS~300MG~A~074844~002~~Dec 23, 1997~No~D
ETOPOSIDE~CAPSULE;ORAL~ETOPOSIDE~MYLAN~50MG~A~075635~001~~Sep 19, 2001~Yes~RX~MY
LAN PHARMACEUTICALS INC
FLUTAMIDE~CAPSULE;ORAL~EULEXIN~SCHERING~125MG~N~018554~001~~Jan 27, 1989~No~DISC
N~SCHERING CORP SUB SCHERING PLOUGH CORP
CEVIMELINE HYDROCHLORIDE~CAPSULE;ORAL~EVOXAC~DAIICHI SANKYO~30MG~N~020989~002~AB
~Jan 11, 2000~Yes~RX~DAIICHI SANKYO INC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~EXELON~NOVARTIS~EQ 1.5MG BASE~N~020823~003~AB
~Apr 21, 2000~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~EXELON~NOVARTIS~EQ 3MG BASE~N~020823~004~AB~A
pr 21, 2000~No~RX~NOVARTIS PHARMACEUTICALS CORP
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~EXELON~NOVARTIS~EQ 4.5MG BASE~N~020823~005~AB
~Apr 21, 2000~No~RX~NOVARTIS PHARMACEUTICALS CORP
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~EXELON~NOVARTIS~EQ 6MG BASE~N~020823~006~AB~A
pr 21, 2000~No~RX~NOVARTIS PHARMACEUTICALS CORP
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~AMNEAL PHARMS NY~100MG E
XTENDED~A~040765~001~AB~Nov 12, 2008~No~RX~AMNEAL PHARMACEUTICALS NY LLC
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~ANI PHARMS INC~100MG EXT
ENDED~A~040435~001~~Jun 20, 2003~No~DISCN~ANI PHARMACEUTICALS INC
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~ANI PHARMS INC~100MG EXT
ENDED~A~089441~001~~Dec 18, 1986~No~DISCN~ANI PHARMACEUTICALS INC
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~MYLAN~100MG EXTENDED~A~0
40298~001~AB~Dec 28, 1998~No~RX~MYLAN PHARMACEUTICALS INC
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~SUN PHARM INDS~200MG EXT
ENDED~A~040731~001~AB~Jun 30, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~SUN PHARM INDS~300MG EXT
ENDED~A~040731~002~AB~Jun 30, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~SUN PHARM INDS (IN)~100M
G EXTENDED~A~040621~001~AB~Dec 11, 2006~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~TARO~100MG EXTENDED~A~04
0684~001~AB~Sep 5, 2006~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~WOCKHARDT~30MG EXTENDED~
A~040759~001~AB~Dec 18, 2007~No~RX~WOCKHARDT LTD
PHENYTOIN SODIUM~CAPSULE;ORAL~EXTENDED PHENYTOIN SODIUM~WOCKHARDT USA~100MG EXTE
NDED~A~040732~001~AB~Jan 30, 2008~No~RX~WOCKHARDT USA INC
PANOBINOSTAT~CAPSULE;ORAL~FARYDAK~NOVARTIS PHARMS CORP~10MG~N~205353~001~~Feb 23
, 2015~No~RX~NOVARTIS PHARMACEUTICALS CORP
, 2015~No~RX~NOVARTIS PHARMACEUTICALS CORP

, 2015~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~FASTIN~GLAXOSMITHKLINE~30MG~N~017352~001~
~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
PIROXICAM~CAPSULE;ORAL~FELDENE~PFIZER~10MG~N~018147~002~AB~Apr 6, 1982~No~RX~PFI
ZER LABORATORIES DIV PFIZER INC
PIROXICAM~CAPSULE;ORAL~FELDENE~PFIZER~20MG~N~018147~003~AB~Apr 6, 1982~Yes~RX~PF
IZER LABORATORIES DIV PFIZER INC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~FEMCET~MALLINCKRODT~325MG;50MG;
40MG~A~089102~001~~Jun 19, 1985~No~DISCN~MALLINCKRODT CHEMICAL INC
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE~RANBAXY LABS LTD~43MG~A~201748~001~AB~Oct 3
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE~RANBAXY LABS LTD~130MG~A~201748~002~AB~Oct
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~APOTEX INC~43MG~A~202252~001~A
B~Jul 26, 2013~No~RX~APOTEX INC
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~APOTEX INC~130MG~A~202252~002~
AB~Jul 26, 2013~No~RX~APOTEX INC
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~DR REDDYS LABS SA~43MG~A~09085
9~001~AB~Mar 1, 2012~No~RX~DR REDDYS LABORATORIES SA
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~DR REDDYS LABS SA~130MG~A~0908
59~002~AB~Mar 1, 2012~No~RX~DR REDDYS LABORATORIES SA
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~IMPAX LABS~67MG~A~075868~001~A
B~Oct 27, 2003~No~RX~IMPAX LABORATORIES INC
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~IMPAX LABS~134MG~A~075868~002~
AB~Oct 27, 2003~No~RX~IMPAX LABORATORIES INC
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~IMPAX LABS~200MG~A~075868~003~
AB~Oct 27, 2003~No~RX~IMPAX LABORATORIES INC
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~MYLAN PHARMS INC~43MG~A~202579
~001~AB~Jan 10, 2013~No~RX~MYLAN PHARMACEUTICALS INC
~001~AB~Oct 23, 2012~No~RX~MYLAN PHARMACEUTICALS INC
9~002~AB~Jan 10, 2013~No~RX~MYLAN PHARMACEUTICALS INC
6~002~AB~Oct 23, 2012~No~RX~MYLAN PHARMACEUTICALS INC
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~TEVA~67MG~A~075753~001~AB~Sep
3, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~TEVA~134MG~A~075753~002~AB~Apr
FENOFIBRATE~CAPSULE;ORAL~FENOFIBRATE (MICRONIZED)~TEVA~200MG~A~075753~003~AB~Apr
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~AM THERAP~EQ 200MG BASE~A~072
307~001~~Aug 22, 1988~No~DISCN~AMERICAN THERAPEUTICS INC
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~AM THERAP~EQ 300MG BASE~A~072
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~HALSEY~EQ 200MG BASE~A~072355
~001~~Aug 17, 1988~No~DISCN~HALSEY DRUG CO INC
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~HALSEY~EQ 300MG BASE~A~072356
~001~~Aug 17, 1988~No~DISCN~HALSEY DRUG CO INC
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~PAR PHARM~EQ 200MG BASE~A~072
437~001~~Aug 22, 1988~No~DISCN~PAR PHARMACEUTICAL INC
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~PAR PHARM~EQ 300MG BASE~A~072
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~QUANTUM PHARMICS~EQ 200MG BAS
E~A~072214~001~~Aug 17, 1988~No~DISCN~QUANTUM PHARMICS LTD
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~QUANTUM PHARMICS~EQ 300MG BAS
E~A~071738~001~~Aug 17, 1988~No~DISCN~QUANTUM PHARMICS LTD
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~SANDOZ~EQ 200MG BASE~A~072394

~001~~Oct 17, 1988~No~DISCN~SANDOZ INC
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~SANDOZ~EQ 300MG BASE~A~072395
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~WARNER CHILCOTT~EQ 200MG BASE
~A~072946~001~~Apr 30, 1991~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~WARNER CHILCOTT~EQ 300MG BASE
~A~072472~001~~Apr 30, 1991~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
FENOPROFEN CALCIUM~CAPSULE;ORAL~FENOPROFEN CALCIUM~WATSON LABS~EQ 200MG BASE~A~0
72294~001~~Aug 17, 1988~No~DISCN~WATSON LABORATORIES INC
FEXOFENADINE HYDROCHLORIDE~CAPSULE;ORAL~FEXOFENADINE HYDROCHLORIDE~BARR~60MG~A~0
76169~001~~Jul 13, 2005~No~DISCN~BARR LABORATORIES INC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE~CAPSULE;ORAL~FIORICET W/
CODEINE~ACTAVIS LABS UT INC~325MG;50MG;40MG;30MG~N~020232~001~AB~Jul 30, 1992~Ye
s~RX~ACTAVIS LABORATORIES UT INC
ASPIRIN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~FIORINAL~ACTAVIS LABS UT INC~325MG;50
MG;40MG~N~017534~005~AA~Apr 16, 1986~Yes~RX~ACTAVIS LABORATORIES UT INC
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE~CAPSULE;ORAL~FIORINAL W/CODEINE
~ACTAVIS LABS UT INC~325MG;50MG;40MG;30MG~N~019429~003~AB~Oct 26, 1990~Yes~RX~AC
TAVIS LABORATORIES UT INC
METRONIDAZOLE~CAPSULE;ORAL~FLAGYL~GD SEARLE LLC~375MG~N~020334~001~AB~May 3, 199
5~Yes~RX~GD SEARLE LLC
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~FLOMAX~BOEHRINGER INGELHEIM~0.4MG~N~020579
~001~AB~Apr 15, 1997~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
FLUCYTOSINE~CAPSULE;ORAL~FLUCYTOSINE~SIGMAPHARM LABS LLC~250MG~A~201566~001~AB~J
un 28, 2011~No~RX~SIGMAPHARM LABORATORIES LLC
FLUCYTOSINE~CAPSULE;ORAL~FLUCYTOSINE~SIGMAPHARM LABS LLC~500MG~A~201566~002~AB~J
un 28, 2011~No~RX~SIGMAPHARM LABORATORIES LLC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE~MUTUAL PHARMA~EQ 10MG BASE~A~07
5787~001~~Jan 29, 2002~No~DISCN~MUTUAL PHARMACAL CO
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE~MUTUAL PHARMA~EQ 20MG BASE~A~07
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE~WATSON LABS~EQ 10MG BASE~A~0756
62~001~~Jan 29, 2002~No~DISCN~WATSON LABORATORIES INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE~WATSON LABS~EQ 20MG BASE~A~0756
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~ALEMBIC PHARMS LT
D~EQ 10MG BASE~A~090223~001~AB1~Mar 19, 2009~No~RX~ALEMBIC PHARMACEUTICALS LTD
D~EQ 20MG BASE~A~090223~002~AB1~Mar 19, 2009~No~RX~ALEMBIC PHARMACEUTICALS LTD
D~EQ 40MG BASE~A~090223~003~AB~Mar 19, 2009~No~RX~ALEMBIC PHARMACEUTICALS LTD
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~ANI PHARMS INC~EQ
10MG BASE~A~076287~001~AB2~May 20, 2008~No~RX~ANI PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~ANI PHARMS INC~EQ
20MG BASE~A~076287~002~AB2~May 20, 2008~No~RX~ANI PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~AUROBINDO PHARMA~
EQ 10MG BASE~A~078619~001~AB1~Jan 31, 2008~No~RX~AUROBINDO PHARMA LTD
EQ 20MG BASE~A~078619~002~AB1~Jan 31, 2008~No~RX~AUROBINDO PHARMA LTD
EQ 40MG BASE~A~078619~003~AB~Jan 31, 2008~No~RX~AUROBINDO PHARMA LTD
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~BARR~EQ 10MG BASE
~A~074803~002~AB1~Jan 30, 2002~No~RX~BARR LABORATORIES INC

~A~074803~001~AB1~Aug 2, 2001~No~RX~BARR LABORATORIES INC
~A~076251~001~~May 18, 2005~No~DISCN~BARR LABORATORIES INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~CARLSBAD~EQ 10MG
BASE~A~076022~001~~Jan 30, 2002~No~DISCN~CARLSBAD TECHNOLOGY INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~CARLSBAD~EQ 20MG
BASE~A~076022~002~~Jan 30, 2002~No~DISCN~CARLSBAD TECHNOLOGY INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~CR DOUBLE CRANE~E
Q 10MG BASE~A~076165~001~~Feb 1, 2002~No~DISCN~CHINA RESOURCES DOUBLE CRANE PHAR
MACEUTICAL CO LTD
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~CR DOUBLE CRANE~E
Q 20MG BASE~A~076165~002~~Feb 1, 2002~No~DISCN~CHINA RESOURCES DOUBLE CRANE PHAR
MACEUTICAL CO LTD
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~DR REDDYS LABS LT
D~EQ 10MG BASE~A~075465~001~AB1~Jan 29, 2002~No~RX~DR REDDYS LABORATORIES LTD
D~EQ 20MG BASE~A~075465~002~AB1~Jan 29, 2002~No~RX~DR REDDYS LABORATORIES LTD
D~EQ 40MG BASE~A~075465~003~AB~Aug 2, 2001~No~RX~DR REDDYS LABORATORIES LTD
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~HERITAGE PHARMS I
NC~EQ 10MG BASE~A~201336~001~AB1~Oct 1, 2012~No~RX~HERITAGE PHARMACEUTICALS INC
NC~EQ 20MG BASE~A~201336~002~AB1~Oct 1, 2012~No~RX~HERITAGE PHARMACEUTICALS INC
NC~EQ 40MG BASE~A~201336~003~AB~Oct 1, 2012~No~RX~HERITAGE PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~IVAX SUB TEVA PHA
RMS~EQ 10MG BASE~A~075245~002~AB1~Jan 31, 2002~No~RX~IVAX PHARMACEUTICALS INC SU
RMS~EQ 20MG BASE~A~075245~001~AB1~Jan 31, 2002~No~RX~IVAX PHARMACEUTICALS INC SU
RMS~EQ 40MG BASE~A~075245~003~AB~Sep 28, 2004~No~RX~IVAX PHARMACEUTICALS INC SUB
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~LANDELA PHARM~EQ
10MG BASE~A~075464~001~AB1~Jan 30, 2002~No~RX~LANDELA PHARMACEUTICAL
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~LANDELA PHARM~EQ
20MG BASE~A~075464~002~AB1~Jan 30, 2002~No~RX~LANDELA PHARMACEUTICAL
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~MALLINCKRODT~EQ 1
0MG BASE~A~075658~001~AB1~Jan 29, 2002~No~RX~MALLINCKRODT INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~MALLINCKRODT~EQ 2
0MG BASE~A~075658~002~AB1~Jan 29, 2002~No~RX~MALLINCKRODT INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~MYLAN~EQ 10MG BAS
E~A~075207~001~AB1~Jan 30, 2002~No~RX~MYLAN PHARMACEUTICALS INC
E~A~078045~001~AB2~Nov 17, 2008~No~RX~MYLAN PHARMACEUTICALS INC
E~A~075207~002~AB1~Jan 30, 2002~No~RX~MYLAN PHARMACEUTICALS INC
E~A~078045~002~AB2~Nov 17, 2008~No~RX~MYLAN PHARMACEUTICALS INC
E~A~075207~003~AB~May 25, 2007~No~RX~MYLAN PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~MYLAN PHARMS INC~
EQ 10MG BASE~A~075577~001~AB1~Jan 29, 2002~No~RX~MYLAN PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~MYLAN PHARMS INC~
EQ 20MG BASE~A~075577~002~AB1~Jan 29, 2002~No~RX~MYLAN PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~PAR PHARM~EQ 10MG
BASE~A~076922~001~~Dec 16, 2004~No~DISCN~PAR PHARMACEUTICAL INC
BASE~A~076922~002~~Dec 16, 2004~No~DISCN~PAR PHARMACEUTICAL INC

BASE~A~076922~003~AB~Dec 16, 2004~No~RX~PAR PHARMACEUTICAL INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~RANBAXY~EQ 40MG B
ASE~A~076990~001~AB~Dec 13, 2004~No~RX~RANBAXY LABORATORIES LTD
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~SANDOZ~EQ 10MG BA
SE~A~075049~001~AB1~Aug 2, 2001~No~RX~SANDOZ INC
SE~A~075807~001~~Jan 29, 2002~No~DISCN~SANDOZ INC
SE~A~077469~001~AB2~Nov 17, 2008~No~RX~SANDOZ INC
SE~A~075049~002~AB1~Jan 29, 2002~No~RX~SANDOZ INC
SE~A~075807~002~~Jan 29, 2002~No~DISCN~SANDOZ INC
SE~A~077469~002~AB2~Nov 17, 2008~No~RX~SANDOZ INC
SE~A~075049~003~AB~Jan 29, 2002~No~RX~SANDOZ INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~TEVA~EQ 10MG BASE
~A~075452~001~AB1~Jan 29, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
~A~075452~002~AB1~Jan 29, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
~A~075452~003~AB~Jan 29, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~TEVA PHARMS USA~E
Q 10MG BASE~A~076001~001~AB1~Jan 29, 2002~No~RX~TEVA PHARMACEUTICALS USA
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~TEVA PHARMS USA~E
Q 20MG BASE~A~076001~002~AB1~Jan 29, 2002~No~RX~TEVA PHARMACEUTICALS USA
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~FLUOXETINE HYDROCHLORIDE~WOCKHARDT LTD~EQ
10MG BASE~A~078143~001~~Jan 16, 2008~No~DISCN~WOCKHARDT LTD
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~HALSEY~15MG~A~071
808~001~~Jan 7, 1988~No~DISCN~HALSEY DRUG CO INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~HALSEY~30MG~A~071
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~HIKMA PHARMS LLC~
15MG~A~071107~001~~Dec 8, 1986~No~DISCN~HIKMA PHARMACEUTICALS LLC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~HIKMA PHARMS LLC~
30MG~A~071108~001~~Dec 8, 1986~No~DISCN~HIKMA PHARMACEUTICALS LLC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~MUTUAL PHARM~15MG
~A~070454~001~~Aug 4, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~MUTUAL PHARM~30MG
~A~070455~001~~Aug 4, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~MYLAN PHARMS INC~
15MG~A~070345~002~~Nov 27, 1985~No~RX~MYLAN PHARMACEUTICALS INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~MYLAN PHARMS INC~
30MG~A~070345~001~~Nov 27, 1985~Yes~RX~MYLAN PHARMACEUTICALS INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~PAR PHARM~15MG~A~
070444~001~~Mar 20, 1986~No~DISCN~PAR PHARMACEUTICAL INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~PAR PHARM~30MG~A~
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~PUREPAC PHARM~15M
G~A~071927~001~~Sep 9, 1987~No~DISCN~PUREPAC PHARMACEUTICAL CO
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~PUREPAC PHARM~30M
G~A~071551~001~~Sep 9, 1987~No~DISCN~PUREPAC PHARMACEUTICAL CO
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~SANDOZ~15MG~A~071
716~001~~Jul 31, 1991~No~DISCN~SANDOZ INC

FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~SANDOZ~30MG~A~071
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~SUPERPHARM~15MG~A
~071659~001~~Aug 4, 1988~No~DISCN~SUPERPHARM CORP
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~SUPERPHARM~30MG~A
~071660~001~~Aug 4, 1988~No~DISCN~SUPERPHARM CORP
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~USL PHARMA~15MG~A
~070562~001~~Jul 9, 1987~No~DISCN~USL PHARMA INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~USL PHARMA~30MG~A
~070563~001~~Jul 9, 1987~No~DISCN~USL PHARMA INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~WARNER CHILCOTT~1
5MG~A~071767~001~~Dec 4, 1987~No~DISCN~WARNER CHILCOTT INC
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~WARNER CHILCOTT~3
0MG~A~071768~001~~Dec 4, 1987~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
FLURAZEPAM HYDROCHLORIDE~CAPSULE;ORAL~FLURAZEPAM HYDROCHLORIDE~WATSON LABS~15MG~
A~071205~001~~Nov 25, 1986~No~DISCN~WATSON LABORATORIES INC
FLUTAMIDE~CAPSULE;ORAL~FLUTAMIDE~ACTAVIS LABS FL INC~125MG~A~075820~001~AB~Sep 1
8, 2001~No~RX~ACTAVIS LABORATORIES FL INC
FLUTAMIDE~CAPSULE;ORAL~FLUTAMIDE~IVAX SUB TEVA PHARMS~125MG~A~075780~001~AB~Sep
19, 2001~Yes~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
FLUTAMIDE~CAPSULE;ORAL~FLUTAMIDE~MYLAN~125MG~A~076224~001~AB~May 9, 2003~No~RX~M
FLUTAMIDE~CAPSULE;ORAL~FLUTAMIDE~PAR PHARM~125MG~A~075298~001~AB~Sep 18, 2001~No
~RX~PAR PHARMACEUTICAL INC
FLUTAMIDE~CAPSULE;ORAL~FLUTAMIDE~SANDOZ~125MG~A~075818~001~~Sep 18, 2001~No~DISC
N~SANDOZ INC
FLUVASTATIN SODIUM~CAPSULE;ORAL~FLUVASTATIN SODIUM~MYLAN PHARMS INC~EQ 20MG BASE
~A~090595~001~AB~Apr 11, 2012~No~RX~MYLAN PHARMACEUTICALS INC.
FLUVASTATIN SODIUM~CAPSULE;ORAL~FLUVASTATIN SODIUM~MYLAN PHARMS INC~EQ 40MG BASE
~A~090595~002~AB~Apr 11, 2012~No~RX~MYLAN PHARMACEUTICALS INC.
FLUVASTATIN SODIUM~CAPSULE;ORAL~FLUVASTATIN SODIUM~TEVA PHARMS~EQ 20MG BASE~A~07
8407~001~AB~Jun 12, 2012~No~RX~TEVA PHARMACEUTICALS USA
FLUVASTATIN SODIUM~CAPSULE;ORAL~FLUVASTATIN SODIUM~TEVA PHARMS~EQ 40MG BASE~A~07
FERROUS SULFATE; FOLIC ACID~CAPSULE;ORAL~FOLVRON~LEDERLE~182MG;0.33MG~N~006012~0
03~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYA
NAMID CO
SAQUINAVIR~CAPSULE;ORAL~FORTOVASE~HOFFMANN LA ROCHE~200MG~N~020828~001~~Nov 7, 1
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~ACTAVIS ELIZABETH~100MG~A~075350~001~AB~Sep 1
2, 2003~No~RX~ACTAVIS ELIZABETH LLC
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~ALKEM~100MG~A~090858~001~AB~Dec 17, 2010~No~R
X~ALKEM LABORATORIES LTD
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~AMNEAL PHARMS NY~100MG~A~078428~001~AB~Jul 25
, 2007~No~RX~AMNEAL PHARMACEUTICALS NY LLC

GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~APOTEX INC~100MG~A~075360~001~AB~Apr 6, 2005~
No~RX~APOTEX INC ETOBICOKE SITE
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~AUROBINDO PHARM~100MG~A~078787~001~AB~Jan 31,
2008~No~RX~AUROBINDO PHARMA USA INC
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~HIKMA~100MG~A~078150~001~AB~Sep 25, 2007~No~R
X~HIKMA PHARMACEUTICALS
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~INVAGEN PHARMS~100MG~A~090705~001~AB~Dec 30,
2009~No~RX~INVAGEN PHARMACEUTICALS INC
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~IVAX SUB TEVA PHARMS~100MG~A~075477~001~~Mar
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~MARKSANS PHARMA~100MG~A~090007~001~AB~Jul 21,
2011~No~RX~MARKSANS PHARMA LTD
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~MUTUAL PHARM~100MG~A~076537~001~~Jun 30, 2005
~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~MYLAN~100MG~A~090158~001~AB~Feb 14, 2011~No~R
X~MYLAN PHARMACEUTICALS INC
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~RANBAXY~100MG~A~076606~001~AB~Oct 7, 2005~No~
RX~RANBAXY LABORATORIES LTD
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~SANDOZ~100MG~A~075428~001~~Jan 24, 2006~No~DI
SCN~SANDOZ INC
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~SANDOZ~100MG~A~075539~001~~Apr 6, 2005~No~DIS
CN~SANDOZ INC
SCN~SANDOZ INC
CN~SANDOZ INC
SCN~SANDOZ INC
CN~SANDOZ INC
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~SUN PHARM INDS LTD~100MG~A~077242~001~AB~Aug
24, 2006~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~TARO~100MG~A~077261~001~AB~Aug 2, 2013~No~RX~
TARO PHARMACEUTICAL INDUSTRIES LTD
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~TEVA PHARMS~100MG~A~075435~001~AB~Oct 8, 2004
~No~RX~TEVA PHARMACEUTICALS USA
GABAPENTIN~CAPSULE;ORAL~GABAPENTIN~WATSON LABS~100MG~A~075485~003~~May 11, 2007~
ZINC ACETATE~CAPSULE;ORAL~GALZIN~TEVA~EQ 25MG ZINC~N~020458~001~~Jan 28, 1997~No
~RX~TEVA PHARMACEUTICALS USA INC
ZINC ACETATE~CAPSULE;ORAL~GALZIN~TEVA~EQ 50MG ZINC~N~020458~002~~Jan 28, 1997~Ye
s~RX~TEVA PHARMACEUTICALS USA INC
GANCICLOVIR~CAPSULE;ORAL~GANCICLOVIR~RANBAXY LABS LTD~250MG~A~076457~001~~Jun 27
, 2003~No~DISCN~RANBAXY LABORATORIES LTD
GANCICLOVIR~CAPSULE;ORAL~GANCICLOVIR~RANBAXY LABS LTD~500MG~A~076457~002~~Jun 27
CROMOLYN SODIUM~CAPSULE;ORAL~GASTROCROM~UCB INC~100MG~N~019188~001~~Dec 22, 1989
~No~DISCN~UCB INC
GEMFIBROZIL~CAPSULE;ORAL~GEMFIBROZIL~MYLAN~300MG~A~073466~001~~Jan 25, 1993~No~D
ISCN~MYLAN PHARMACEUTICALS INC
GEMFIBROZIL~CAPSULE;ORAL~GEMFIBROZIL~PUREPAC PHARM~300MG~A~072929~001~~Jan 29, 1
993~No~DISCN~PUREPAC PHARMACEUTICAL CO
CYCLOSPORINE~CAPSULE;ORAL~GENGRAF~ABBVIE~25MG~A~065003~001~AB1~May 12, 2000~No~R
X~ABBVIE INC
CYCLOSPORINE~CAPSULE;ORAL~GENGRAF~ABBVIE~50MG~A~065003~002~AB1~May 12, 2000~No~R
X~ABBVIE INC
CYCLOSPORINE~CAPSULE;ORAL~GENGRAF~ABBVIE~100MG~A~065003~003~AB1~May 12, 2000~No~
RX~ABBVIE INC
ZIPRASIDONE HYDROCHLORIDE~CAPSULE;ORAL~GEODON~PFIZER~EQ 20MG BASE~N~020825~001~A
B~Feb 5, 2001~Yes~RX~PFIZER INC
B~Feb 5, 2001~No~RX~PFIZER INC

FINGOLIMOD~CAPSULE;ORAL~GILENYA~NOVARTIS~0.5MG~N~022527~001~~Sep 21, 2010~Yes~RX
IMATINIB MESYLATE~CAPSULE;ORAL~GLEEVEC~NOVARTIS~EQ 50MG BASE~N~021335~001~~May 1
0, 2001~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
IMATINIB MESYLATE~CAPSULE;ORAL~GLEEVEC~NOVARTIS~EQ 100MG BASE~N~021335~002~~May
LOMUSTINE~CAPSULE;ORAL~GLEOSTINE~CORDEN PHARMA~5MG~N~017588~004~~Dec 19, 2014~No
~RX~CORDEN PHARMA LATINA SPA
LOMUSTINE~CAPSULE;ORAL~GLEOSTINE~CORDEN PHARMA~10MG~N~017588~001~~Approved Prior
to Jan 1, 1982~No~RX~CORDEN PHARMA LATINA SPA
LOMUSTINE~CAPSULE;ORAL~GLEOSTINE~CORDEN PHARMA~40MG~N~017588~002~~Approved Prior
to Jan 1, 1982~No~RX~CORDEN PHARMA LATINA SPA
LOMUSTINE~CAPSULE;ORAL~GLEOSTINE~CORDEN PHARMA~100MG~N~017588~003~~Approved Prio
r to Jan 1, 1982~Yes~RX~CORDEN PHARMA LATINA SPA
GRISEOFULVIN, MICROCRYSTALLINE~CAPSULE;ORAL~GRISACTIN~WYETH AYERST~125MG~N~05005
1~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
GRISEOFULVIN, MICROCRYSTALLINE~CAPSULE;ORAL~GRISACTIN~WYETH AYERST~250MG~N~05005
DOXERCALCIFEROL~CAPSULE;ORAL~HECTOROL~GENZYME CORP~0.5MCG~N~020862~002~AB~Apr 23
, 2004~No~RX~GENZYME CORP
DOXERCALCIFEROL~CAPSULE;ORAL~HECTOROL~GENZYME CORP~1MCG~N~020862~003~AB~Jul 13,
2009~No~RX~GENZYME CORP
DOXERCALCIFEROL~CAPSULE;ORAL~HECTOROL~GENZYME CORP~2.5MCG~N~020862~001~AB~Jun 9,
1999~Yes~RX~GENZYME CORP
TASIMELTEON~CAPSULE;ORAL~HETLIOZ~VANDA PHARMS INC~20MG~N~205677~001~~Jan 31, 201
4~Yes~RX~VANDA PHARMACEUTICALS INC
ALTRETAMINE~CAPSULE;ORAL~HEXALEN~EISAI INC~50MG~N~019926~001~~Dec 26, 1990~Yes~R
X~EISAI INC
PAROMOMYCIN SULFATE~CAPSULE;ORAL~HUMATIN~KING PFIZER~EQ 250MG BASE~A~062310~001~
~Approved Prior to Jan 1, 1982~No~DISCN~KING PHARMACEUTICALS INC SUB PFIZER INC
PAROMOMYCIN SULFATE~CAPSULE;ORAL~HUMATIN~PARKEDALE~EQ 250MG BASE~A~060521~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~"HY-PAM ""25"""~TEVA~EQ 25MG HCL~A~088713~001~~
Mar 4, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
TOPOTECAN HYDROCHLORIDE~CAPSULE;ORAL~HYCAMTIN~GLAXO WELLCOME~EQ 0.25MG BASE~N~02
0981~001~~Oct 11, 2007~No~RX~GLAXOSMITHKLINE
TOPOTECAN HYDROCHLORIDE~CAPSULE;ORAL~HYCAMTIN~GLAXO WELLCOME~EQ 1MG BASE~N~02098
1~002~~Oct 11, 2007~Yes~RX~GLAXOSMITHKLINE
ERGOLOID MESYLATES~CAPSULE;ORAL~HYDERGINE LC~NOVARTIS~1MG~N~018706~001~~Jan 18,
1983~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDRA-ZIDE~PAR PHARM
~25MG;25MG~A~088957~001~~Oct 21, 1985~No~RX~PAR PHARMACEUTICAL INC
~50MG;50MG~A~088946~001~~Oct 21, 1985~Yes~RX~PAR PHARMACEUTICAL INC
~100MG;50MG~A~088961~001~~Oct 21, 1985~No~DISCN~PAR PHARMACEUTICAL INC
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDRALAZINE HYDROCHL
ORIDE AND HYDROCHLOROTHIAZIDE~SOLVAY~25MG;25MG~A~087608~001~~Feb 8, 1982~No~DISC
N~SOLVAY PHARMACEUTICALS
ORIDE AND HYDROCHLOROTHIAZIDE~SOLVAY~50MG;50MG~A~087213~001~~Feb 8, 1982~No~DISC
N~SOLVAY PHARMACEUTICALS
ORIDE AND HYDROCHLOROTHIAZIDE~SOLVAY~100MG;50MG~A~087609~001~~Feb 8, 1982~No~DIS
CN~SOLVAY PHARMACEUTICALS
ORIDE AND HYDROCHLOROTHIAZIDE~SUPERPHARM~25MG;25MG~A~089200~001~~Feb 9, 1987~No~
DISCN~SUPERPHARM CORP

ORIDE AND HYDROCHLOROTHIAZIDE~SUPERPHARM~50MG;50MG~A~089201~001~~Feb 9, 1987~No~
ORIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~25MG;25MG~A~085457~001~~Mar 4, 1982~No
ORIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~50MG;50MG~A~085446~001~~Mar 4, 1982~No
ORIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~100MG;50MG~A~085440~001~~Mar 4, 1982~N
o~DISCN~WATSON LABORATORIES INC
ORIDE W/ HYDROCHLOROTHIAZIDE 100/50~IVAX PHARMS~100MG;50MG~A~088358~001~~Apr 10,
1984~No~DISCN~IVAX PHARMACEUTICALS INC
ORIDE W/ HYDROCHLOROTHIAZIDE 25/25~IVAX PHARMS~25MG;25MG~A~088356~001~~Apr 10, 1
ORIDE W/ HYDROCHLOROTHIAZIDE 50/50~IVAX PHARMS~50MG;50MG~A~088357~001~~Apr 10, 1
HYDROXYUREA~CAPSULE;ORAL~HYDREA~BRISTOL MYERS SQUIBB~500MG~N~016295~001~AB~Appro
ved Prior to Jan 1, 1982~Yes~RX~BRISTOL MYERS SQUIBB CO
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~ALEMBIC PHARMS LTD~12.5MG~A
~200645~001~AB~Nov 30, 2010~No~RX~ALEMBIC PHARMACEUTICALS LTD
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~APOTEX~12.5MG~A~078389~001~
AB~May 16, 2008~No~RX~APOTEX INC
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~AUROBINDO PHARMA~12.5MG~A~0
78164~001~AB~Sep 18, 2007~No~RX~AUROBINDO PHARMA LTD
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~HIKMA INTL PHARMS~12.5MG~A~
077885~001~~Nov 26, 2007~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~IPCA LABS LTD~12.5MG~A~0792
37~001~AB~Apr 2, 2009~No~RX~IPCA LABORATORIES LTD
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~12.5MG
~A~077005~001~AB~Jul 13, 2005~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUT
ICALS USA
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~JUBILANT CADISTA~12.5MG~A~0
78391~001~AB~Feb 11, 2008~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~LANNETT HOLDINGS INC~12.5MG
~A~091662~001~AB~Jan 27, 2012~No~RX~LANNETT HOLDINGS INC
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~MYLAN~12.5MG~A~075640~001~A
B~Jan 28, 2000~No~RX~MYLAN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~SUN PHARM INDS INC~12.5MG~A
~090651~001~AB~Apr 7, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~UNICHEM~12.5MG~A~090510~001
~AB~Jan 19, 2010~No~RX~UNICHEM LABORATORIES LTD
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~HYDROCHLOROTHIAZIDE~VINTAGE PHARMS~12.5MG~A~075
907~001~AB~Sep 17, 2002~No~RX~VINTAGE PHARMACEUTICALS INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~CAPSULE;ORAL~HYDROCODONE BITARTRATE AND AC
ETAMINOPHEN~MALLINCKRODT~500MG;5MG~A~088956~001~~Jul 19, 1985~No~DISCN~MALLINCKR
ODT CHEMICAL INC
ETAMINOPHEN~MALLINCKRODT~500MG;5MG~A~089006~001~~Aug 9, 1985~No~DISCN~MALLINCKRO
DT CHEMICAL INC
ETAMINOPHEN~MIKART~500MG;5MG~A~081067~001~~Nov 30, 1989~No~DISCN~MIKART INC

ETAMINOPHEN~MIKART~500MG;5MG~A~089008~001~~Feb 21, 1986~No~DISCN~MIKART INC
HYDROXYUREA~CAPSULE;ORAL~HYDROXYUREA~BARR~250MG~A~075143~002~~Sep 21, 2000~No~DI
SCN~BARR LABORATORIES INC
HYDROXYUREA~CAPSULE;ORAL~HYDROXYUREA~BARR~500MG~A~075143~001~AB~Oct 16, 1998~No~
HYDROXYUREA~CAPSULE;ORAL~HYDROXYUREA~BARR LABS INC~250MG~A~075020~002~~Jun 26, 2
000~No~DISCN~BARR LABORATORIES INC
HYDROXYUREA~CAPSULE;ORAL~HYDROXYUREA~BARR LABS INC~500MG~A~075020~001~~Jul 30, 1
HYDROXYUREA~CAPSULE;ORAL~HYDROXYUREA~PAR PHARM~500MG~A~075340~001~AB~Feb 24, 199
HYDROXYUREA~CAPSULE;ORAL~HYDROXYUREA~ROXANE~500MG~A~074476~001~~Aug 18, 1995~No~
DISCN~ROXANE LABORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~BARR~EQ 25MG HCL~A~088496~0
01~AB~Jun 15, 1984~No~RX~BARR LABORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~BARR~EQ 50MG HCL~A~088487~0
01~AB~Jun 15, 1984~No~RX~BARR LABORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~BARR~EQ 100MG HCL~A~088488~
001~~Jun 15, 1984~No~RX~BARR LABORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~DURAMED PHARMS BARR~EQ 25MG
HCL~A~088593~001~~Feb 29, 1984~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LA
BORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~DURAMED PHARMS BARR~EQ 50MG
HCL~A~088594~001~~Feb 29, 1984~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LA
BORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~DURAMED PHARMS BARR~EQ 100M
G HCL~A~088595~001~~Feb 29, 1984~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR L
ABORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~EMCURE PHARMS USA~EQ 25MG H
YDROCHLORIDE~A~201507~001~AB~Jun 3, 2013~No~RX~EMCURE PHARMACEUTICALS USA INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~EMCURE PHARMS USA~EQ 50MG H
YDROCHLORIDE~A~201507~002~AB~Jun 3, 2013~No~RX~EMCURE PHARMACEUTICALS USA INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~IVAX SUB TEVA PHARMS~EQ 25M
G HCL~A~087761~001~~Mar 5, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~IVAX SUB TEVA PHARMS~EQ 50M
G HCL~A~087760~001~~Mar 5, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~PAR PHARM~EQ 25MG HCL~A~087
656~001~~Jun 11, 1982~No~DISCN~PAR PHARMACEUTICAL INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~SANDOZ~EQ 25MG HCL~A~081127
~001~~Jun 28, 1991~No~DISCN~SANDOZ INC
~001~AB~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
~001~~Jun 28, 1991~No~DISCN~SANDOZ INC
~001~AB~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
9~001~~Jun 28, 1991~No~DISCN~SANDOZ INC

HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~SUPERPHARM~EQ 25MG HCL~A~08
9031~001~~Jan 2, 1987~No~DISCN~SUPERPHARM CORP
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~VANGARD~EQ 25MG HCL~A~08839
2~001~~Sep 19, 1983~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~VANGARD~EQ 50MG HCL~A~08839
3~001~~Sep 19, 1983~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~WATSON LABS~EQ 25MG HCL~A~0
40156~001~AB~Jul 15, 1996~No~RX~WATSON LABORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~WATSON LABS~EQ 25MG HYDROCH
LORIDE~A~081165~001~~Jul 31, 1991~No~DISCN~WATSON LABORATORIES INC
86840~001~~Jul 1, 1982~No~DISCN~WATSON LABORATORIES INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~HYDROXYZINE PAMOATE~WATSON LABS~EQ 100MG HCL~A~
086728~001~~Oct 5, 1982~No~DISCN~WATSON LABORATORIES INC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~HYTRIN~ABBOTT~EQ 1MG BASE **Federal Registe
r determination that product was not discontinued or withdrawn for safety or eff
icacy reasons**~N~020347~001~~Dec 14, 1994~No~DISCN~ABBOTT LABORATORIES PHARMACE
UTICAL PRODUCTS DIV
UTICAL PRODUCTS DIV
UTICAL PRODUCTS DIV
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~HYTRIN~ABBOTT~EQ 10MG BASE **Federal Regist
ficacy reasons**~N~020347~004~~Dec 14, 1994~No~DISCN~ABBOTT LABORATORIES PHARMAC
EUTICAL PRODUCTS DIV
PALBOCICLIB~CAPSULE;ORAL~IBRANCE~PFIZER INC~75MG~N~207103~001~~Feb 3, 2015~No~RX
~PFIZER INC
PALBOCICLIB~CAPSULE;ORAL~IBRANCE~PFIZER INC~100MG~N~207103~002~~Feb 3, 2015~No~R
X~PFIZER INC
PALBOCICLIB~CAPSULE;ORAL~IBRANCE~PFIZER INC~125MG~N~207103~003~~Feb 3, 2015~Yes~
RX~PFIZER INC
IBUPROFEN~CAPSULE;ORAL~IBUPROFEN~AMNEAL PHARMS~EQ 200MG FREE ACID AND POTASSIUM
SALT~A~202300~001~~Dec 23, 2011~No~OTC~AMNEAL PHARMACEUTICALS
IBUPROFEN~CAPSULE;ORAL~IBUPROFEN~BANNER LIFE SCIENCES~EQ 200MG FREE ACID AND POT
ASSIUM SALT~A~078682~001~~Mar 24, 2009~No~OTC~BANNER LIFE SCIENCES LLC
IBUPROFEN~CAPSULE;ORAL~IBUPROFEN~CONTRACT PHARMACAL~200MG~A~074782~001~~Jul 6, 1
998~Yes~OTC~CONTRACT PHARMACAL CORP

IBUPROFEN~CAPSULE;ORAL~IBUPROFEN~MARKSANS PHARMA~EQ 200MG FREE ACID AND POTASSIU
M SALT~A~079205~001~~Jun 26, 2009~No~OTC~MARKSANS PHARMA LTD
IBUPROFEN~CAPSULE;ORAL~IBUPROFEN~P AND L DEV LLC~EQ 200MG FREE ACID AND POTASSIU
M SALT~A~077338~001~~Jul 10, 2009~No~OTC~P AND L DEVELOPMENT LLC DBA PLD DEVELOP
MENTS LLC
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN~CAPSULE;ORAL~IBUPROFEN AND DIPHENHYDRAM
INE HYDROCHLORIDE~BANNER LIFE SCIENCES~25MG;EQ 200MG FREE ACID AND POTASSIUM SAL
T~A~090397~001~~Nov 22, 2010~No~OTC~BANNER LIFE SCIENCES LLC
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN~CAPSULE;ORAL~IBUPROFEN AND DIPHENHYDRAM
INE HYDROCHLORIDE~STRIDES PHARMA~25MG;EQ 200MG FREE ACID AND POTASSIUM SALT~A~20
0888~001~~Mar 5, 2012~No~OTC~STRIDES PHARMA GLOBAL PTE LTD
ERYTHROMYCIN ESTOLATE~CAPSULE;ORAL~ILOSONE~LILLY~EQ 125MG BASE~A~061897~001~~App
roved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
ERYTHROMYCIN ESTOLATE~CAPSULE;ORAL~ILOSONE~LILLY~EQ 250MG BASE~A~061897~002~~App
roved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
IBRUTINIB~CAPSULE;ORAL~IMBRUVICA~PHARMACYCLICS INC~140MG~N~205552~001~~Nov 13, 2
013~Yes~RX~PHARMACYCLICS INC
IMIPRAMINE PAMOATE~CAPSULE;ORAL~IMIPRAMINE PAMOATE~LUPIN LTD~EQ 75MG HCL~A~09044
4~001~AB~Apr 16, 2010~No~RX~LUPIN LTD
IMIPRAMINE PAMOATE~CAPSULE;ORAL~IMIPRAMINE PAMOATE~MYLAN PHARMS INC~EQ 75MG HCL~
A~202338~001~AB~Jun 28, 2013~No~RX~MYLAN PHARMACEUTICALS INC
IMIPRAMINE PAMOATE~CAPSULE;ORAL~IMIPRAMINE PAMOATE~MYLAN PHARMS INC~EQ 100MG HCL
~A~202338~002~AB~Jun 28, 2013~No~RX~MYLAN PHARMACEUTICALS INC
IMIPRAMINE PAMOATE~CAPSULE;ORAL~IMIPRAMINE PAMOATE~ROXANE~EQ 75MG HCL~A~091099~0
01~AB~Apr 16, 2010~No~RX~ROXANE LABORATORIES INC
IMIPRAMINE PAMOATE~CAPSULE;ORAL~IMIPRAMINE PAMOATE~ROXANE~EQ 100MG HCL~A~091099~
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~IMODIUM~MCNEIL CONS~2MG~N~017694~001~AB~Ap
proved Prior to Jan 1, 1982~Yes~RX~MCNEIL CONSUMER HEALTHCARE
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~IMODIUM~MCNEIL PED~2MG~N~017690~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~MCNEIL PEDIATRICS
MILTEFOSINE~CAPSULE;ORAL~IMPAVIDO~KNIGHT THERAPS~50MG~N~204684~001~~Mar 19, 2014
~Yes~RX~KNIGHT THERAPEUTICS USA INC
INDOMETHACIN~CAPSULE;ORAL~INDO-LEMMON~TEVA~25MG~A~070266~001~~Nov 7, 1985~No~DIS
CN~TEVA PHARMACEUTICALS USA INC
INDOMETHACIN~CAPSULE;ORAL~INDO-LEMMON~TEVA~50MG~A~070267~001~~Nov 7, 1985~No~DIS
CN~TEVA PHARMACEUTICALS USA INC
INDOMETHACIN~CAPSULE;ORAL~INDOCIN~IROKO PHARMS LLC~25MG~N~016059~001~~Approved P
rior to Jan 1, 1982~No~DISCN~IROKO PHARMACEUTICALS LLC
INDOMETHACIN~CAPSULE;ORAL~INDOCIN~IROKO PHARMS LLC~50MG~N~016059~002~~Approved P
rior to Jan 1, 1982~No~DISCN~IROKO PHARMACEUTICALS LLC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~ABLE~25MG~A~076666~001~~Dec 17, 2003~No~D
ISCN~ABLE LABORATORIES INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~ABLE~50MG~A~076666~002~~Dec 17, 2003~No~D
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~CYCLE PHARMS LTD~25MG~A~070353~001~~Jun 1

8, 1985~No~DISCN~CYCLE PHARMACEUTICALS LTD
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~CYCLE PHARMS LTD~50MG~A~070354~001~~Jun 1
8, 1985~No~DISCN~CYCLE PHARMACEUTICALS LTD
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~DURAMED PHARMS BARR~25MG~A~070326~001~~Oc
t 18, 1985~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~DURAMED PHARMS BARR~50MG~A~070327~001~~Oc
t 18, 1985~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~GLENMARK GENERICS~25MG~A~091276~001~AB~De
c 22, 2010~No~RX~GLENMARK GENERICS LTD INDIA
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~GLENMARK GENERICS~50MG~A~091276~002~AB~De
c 22, 2010~No~RX~GLENMARK GENERICS LTD INDIA
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~HALSEY~25MG~A~070782~001~~Jun 3, 1987~No~
DISCN~HALSEY DRUG CO INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~HALSEY~50MG~A~070635~001~~Jun 3, 1987~No~
DISCN~HALSEY DRUG CO INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~HERITAGE PHARMS INC~25MG~N~018851~001~AB~
May 18, 1984~No~RX~HERITAGE PHARMACEUTICALS INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~HERITAGE PHARMS INC~50MG~N~018851~002~AB~
May 18, 1984~No~RX~HERITAGE PHARMACEUTICALS INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~HETERO LABS LTD III~25MG~A~091240~001~AB~
Apr 12, 2011~No~RX~HETERO LABS LTD UNIT III
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~HETERO LABS LTD III~50MG~A~091240~002~AB~
Apr 12, 2011~No~RX~HETERO LABS LTD UNIT III
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~IVAX SUB TEVA PHARMS~25MG~A~070719~001~AB
~Feb 12, 1986~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~IVAX SUB TEVA PHARMS~25MG~N~018730~001~~M
ay 4, 1984~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~IVAX SUB TEVA PHARMS~50MG~A~070756~001~AB
~Feb 12, 1986~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~IVAX SUB TEVA PHARMS~50MG~N~018730~002~~M
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~MUTUAL PHARM~25MG~A~070067~001~~Oct 3, 19
86~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~MUTUAL PHARM~25MG~A~070899~001~~Feb 9, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~MUTUAL PHARM~50MG~A~070068~001~~Oct 3, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~MUTUAL PHARM~50MG~A~070900~001~~Feb 9, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~MYLAN~25MG~N~018858~001~AB~Apr 20, 1984~N
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~MYLAN~50MG~A~070624~001~AB~Sep 4, 1985~Ye
s~RX~MYLAN PHARMACEUTICALS INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~MYLAN~50MG~N~018858~002~~Apr 20, 1984~No~
DISCN~MYLAN PHARMACEUTICALS INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~PARKE DAVIS~25MG~N~018806~001~~Nov 23, 19
84~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~PARKE DAVIS~50MG~N~018806~002~~Nov 23, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~PIONEER PHARMS~25MG~A~070813~001~~Aug 11,
1986~No~DISCN~PIONEER PHARMACEUTICALS INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~PIONEER PHARMS~50MG~A~070592~001~~Aug 11,
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~PLIVA~25MG~A~071148~001~~Mar 18, 1987~No~
DISCN~PLIVA INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~PLIVA~50MG~A~071149~001~~Mar 18, 1987~No~
DISCN~PLIVA INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~SANDOZ~25MG~A~070673~001~AB~Apr 29, 1987~
No~RX~SANDOZ INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~SANDOZ~50MG~A~070674~001~AB~Apr 29, 1987~

No~RX~SANDOZ INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~SUN PHARM INDS INC~25MG~A~091401~001~AB~M
ar 28, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~SUN PHARM INDS INC~50MG~A~091401~002~AB~M
ar 28, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~SUPERPHARM~25MG~A~070487~001~~Oct 10, 198
6~No~DISCN~SUPERPHARM CORP
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~SUPERPHARM~50MG~A~070488~001~~Oct 10, 198
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~TEVA~25MG~A~071342~001~~Apr 18, 1988~No~D
ISCN~TEVA PHARMACEUTICALS USA INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~TEVA~50MG~A~071343~001~~Apr 18, 1988~No~D
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~VINTAGE~25MG~N~018829~002~~Aug 6, 1984~No
~DISCN~VINTAGE PHARMACEUTICALS LLC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~VINTAGE~50MG~A~070651~001~~Mar 5, 1986~No
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~VINTAGE~50MG~N~018829~001~~Aug 6, 1984~No
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~25MG~A~070529~001~~Oct 18, 19
85~No~DISCN~WATSON LABORATORIES INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~25MG~A~070784~001~~Aug 20, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~25MG~A~072996~001~~Jul 31, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~25MG~N~018690~001~~Jul 31, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~50MG~A~070530~001~~Oct 18, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~50MG~A~070785~001~~Aug 20, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~50MG~A~071635~001~~May 18, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~50MG~A~072997~001~~Jul 31, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~WATSON LABS~50MG~N~018690~002~~Jul 31, 19
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~ZYDUS PHARMS USA INC~25MG~A~090403~001~AB
~Nov 15, 2010~No~RX~ZYDUS PHARMACEUTICALS USA INC
INDOMETHACIN~CAPSULE;ORAL~INDOMETHACIN~ZYDUS PHARMS USA INC~50MG~A~090403~002~AB
~Nov 15, 2010~No~RX~ZYDUS PHARMACEUTICALS USA INC
SAQUINAVIR MESYLATE~CAPSULE;ORAL~INVIRASE~HOFFMANN LA ROCHE~EQ 200MG BASE~N~0206
28~001~~Dec 6, 1995~Yes~RX~HOFFMANN LA ROCHE INC
SODIUM IODIDE I-131~CAPSULE;ORAL~IODOTOPE~BRACCO~1-130mCi~N~010929~001~~Approved
Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
SODIUM IODIDE I-131~CAPSULE;ORAL~IODOTOPE~BRACCO~1-150mCi~N~010929~003~~Approved
ISRADIPINE~CAPSULE;ORAL~ISRADIPINE~MIKAH PHARMA~2.5MG~A~077169~001~AB~Apr 24, 20
06~No~RX~MIKAH PHARMA LLC
ISRADIPINE~CAPSULE;ORAL~ISRADIPINE~MIKAH PHARMA~5MG~A~077169~002~AB~Apr 24, 2006
~No~RX~MIKAH PHARMA LLC
ISRADIPINE~CAPSULE;ORAL~ISRADIPINE~WATSON LABS~2.5MG~A~077317~001~AB~Jan 5, 2006
~No~RX~WATSON LABORATORIES INC
ISRADIPINE~CAPSULE;ORAL~ISRADIPINE~WATSON LABS~5MG~A~077317~002~AB~Jan 5, 2006~Y
es~RX~WATSON LABORATORIES INC
ITRACONAZOLE~CAPSULE;ORAL~ITRACONAZOLE~MYLAN PHARMS INC~100MG~A~200463~001~AB~Ju
l 20, 2012~No~RX~MYLAN PHARMACEUTICALS INC
ITRACONAZOLE~CAPSULE;ORAL~ITRACONAZOLE~SANDOZ~100MG~A~076104~001~AB~May 28, 2004
~No~RX~SANDOZ INC
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~JALYN~GLAXOSMITHKLINE~0.5MG;0

.4MG~N~022460~001~AB~Jun 14, 2010~Yes~RX~GLAXOSMITHKLINE
LOMITAPIDE MESYLATE~CAPSULE;ORAL~JUXTAPID~AEGERION~EQ 5MG BASE~N~203858~001~~Dec
21, 2012~No~RX~AEGERION PHARMACEUTICALS INC
LOMITAPIDE MESYLATE~CAPSULE;ORAL~JUXTAPID~AEGERION~EQ 10MG BASE~N~203858~002~~De
c 21, 2012~No~RX~AEGERION PHARMACEUTICALS INC
LOMITAPIDE MESYLATE~CAPSULE;ORAL~JUXTAPID~AEGERION~EQ 20MG BASE~N~203858~003~~De
c 21, 2012~Yes~RX~AEGERION PHARMACEUTICALS INC
CEPHALOGLYCIN~CAPSULE;ORAL~KAFOCIN~LILLY~250MG~N~050219~001~~Approved Prior to J
an 1, 1982~No~DISCN~ELI LILLY AND CO
LOPINAVIR; RITONAVIR~CAPSULE;ORAL~KALETRA~ABBVIE~133.3MG;33.3MG~N~021226~001~~Se
p 15, 2000~Yes~RX~ABBVIE INC
KANAMYCIN SULFATE~CAPSULE;ORAL~KANTREX~APOTHECON~EQ 500MG BASE~A~060516~001~~App
roved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
KANAMYCIN SULFATE~CAPSULE;ORAL~KANTREX~APOTHECON~EQ 500MG BASE~A~061911~001~~App
KANAMYCIN SULFATE~CAPSULE;ORAL~KANTREX~APOTHECON~EQ 500MG BASE~A~062726~001~~Mar
6, 1987~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CEPHALEXIN~CAPSULE;ORAL~KEFLEX~SHIONOGI INC~EQ 250MG BASE~N~050405~002~AB~Approv
ed Prior to Jan 1, 1982~No~RX~SHIONOGI INC
CEPHALEXIN~CAPSULE;ORAL~KEFLEX~SHIONOGI INC~EQ 333MG BASE~N~050405~004~~May 12,
2006~No~DISCN~SHIONOGI INC
CEPHALEXIN~CAPSULE;ORAL~KEFLEX~SHIONOGI INC~EQ 500MG BASE~N~050405~003~AB~Approv
ed Prior to Jan 1, 1982~No~RX~SHIONOGI INC
CEPHALEXIN~CAPSULE;ORAL~KEFLEX~SHIONOGI INC~EQ 750MG BASE~N~050405~005~AB~May 12
, 2006~Yes~RX~SHIONOGI INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~KESSO-GESIC~MK LABS~65MG~A~083544~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~MK LABORATORIES INC
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~DORADO PHARMA~25MG~A~074014~001~~Jan 29, 1993
~No~RX~DORADO PHARMA LLC
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~DORADO PHARMA~50MG~A~074014~002~AB~Jan 29, 19
93~No~RX~DORADO PHARMA LLC
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~DORADO PHARMA~75MG~A~074014~003~AB~Jan 29, 19
93~No~RX~DORADO PHARMA LLC
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~MYLAN~50MG~A~074035~002~AB~Dec 31, 1996~No~RX
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~MYLAN~75MG~A~074035~003~AB~Dec 31, 1996~No~RX
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~SANDOZ~50MG~A~074024~001~~Dec 29, 1995~No~DIS
CN~SANDOZ INC
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~SANDOZ~75MG~A~074024~002~~Dec 29, 1995~No~DIS
CN~SANDOZ INC
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~TEVA~25MG~A~073515~001~~Dec 22, 1992~No~DISCN
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~TEVA~50MG~A~073516~001~AB~Dec 22, 1992~No~RX~
KETOPROFEN~CAPSULE;ORAL~KETOPROFEN~TEVA~75MG~A~073517~001~AB~Dec 22, 1992~Yes~RX
CLOFAZIMINE~CAPSULE;ORAL~LAMPRENE~NOVARTIS~50MG~N~019500~002~~Dec 15, 1986~Yes~R
X~NOVARTIS PHARMACEUTICALS CORP
CLOFAZIMINE~CAPSULE;ORAL~LAMPRENE~NOVARTIS~100MG~N~019500~001~~Dec 15, 1986~No~D
ISCN~NOVARTIS PHARMACEUTICALS CORP
ASPIRIN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~LANORINAL~LANNETT~325MG;50MG;40MG~A~0
86996~002~AA~Oct 11, 1985~No~RX~LANNETT CO INC
DIGOXIN~CAPSULE;ORAL~LANOXICAPS~GLAXOSMITHKLINE LLC~0.05MG~N~018118~002~~Jul 26,
1982~No~DISCN~GLAXOSMITHKLINE LLC
DIGOXIN~CAPSULE;ORAL~LANOXICAPS~GLAXOSMITHKLINE LLC~0.15MG~N~018118~004~~Sep 24,

LEVODOPA~CAPSULE;ORAL~LARODOPA~ROCHE~100MG~N~016912~002~~Approved Prior to Jan 1
, 1982~No~DISCN~HOFFMANN LA ROCHE INC
LENVATINIB MESYLATE~CAPSULE;ORAL~LENVIMA~EISAI INC~EQ 4MG BASE~N~206947~001~~Feb
13, 2015~No~RX~EISAI INC
LENVATINIB MESYLATE~CAPSULE;ORAL~LENVIMA~EISAI INC~EQ 10MG BASE~N~206947~002~~Fe
b 13, 2015~Yes~RX~EISAI INC
FLUVASTATIN SODIUM~CAPSULE;ORAL~LESCOL~NOVARTIS~EQ 20MG BASE~N~020261~001~AB~Dec
31, 1993~No~RX~NOVARTIS PHARMACEUTICALS CORP
FLUVASTATIN SODIUM~CAPSULE;ORAL~LESCOL~NOVARTIS~EQ 40MG BASE~N~020261~002~AB~Dec
31, 1993~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~LIBRIUM~VALEANT PHARM INTL~5MG~A~085
461~001~AB~Approved Prior to Jan 1, 1982~No~RX~VALEANT PHARMACEUTICALS INTERNATI
ONAL
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~LIBRIUM~VALEANT PHARM INTL~5MG~N~012
249~002~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNAT
IONAL
5472~001~AB~Approved Prior to Jan 1, 1982~No~RX~VALEANT PHARMACEUTICALS INTERNAT
IONAL
2249~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNA
TIONAL
5475~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNA
TIONAL
TIONAL
LINCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~LINCOCIN~PHARMACIA AND UPJOHN~EQ 250MG BAS
E~N~050316~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
LINCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~LINCOCIN~PHARMACIA AND UPJOHN~EQ 500MG BAS
E~N~050316~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
LINACLOTIDE~CAPSULE;ORAL~LINZESS~FOREST LABS INC~145MCG~N~202811~001~~Aug 30, 20
LINACLOTIDE~CAPSULE;ORAL~LINZESS~FOREST LABS INC~290MCG~N~202811~002~~Aug 30, 20
12~Yes~RX~FOREST LABORATORIES INC
FENOFIBRATE~CAPSULE;ORAL~LIPIDIL~ABBVIE~100MG~N~019304~001~~Dec 31, 1993~No~DISC
N~ABBVIE INC
FENOFIBRATE~CAPSULE;ORAL~LIPOFEN~CIPHER PHARMS INC~50MG~N~021612~001~~Jan 11, 20
06~No~RX~CIPHER PHARMACEUTICALS INC
006~No~DISCN~CIPHER PHARMACEUTICALS INC
006~Yes~RX~CIPHER PHARMACEUTICALS INC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~ABLE~150MG~A~076823~001~~Jun 29
, 2004~No~DISCN~ABLE LABORATORIES INC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~ABLE~300MG~A~076121~001~~Sep 27
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~ALEMBIC LTD~150MG~A~079159~001~
AB~Jan 12, 2009~No~RX~ALEMBIC LTD

LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~APOTEX INC~300MG~A~076795~001~~
Nov 22, 2004~No~DISCN~APOTEX INC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~GLENMARK GENERICS~150MG~A~07913
9~001~AB~Feb 3, 2009~No~RX~GLENMARK GENERICS LTD
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~HETERO LABS LTD III~150MG~A~090
702~001~AB~Sep 25, 2009~No~RX~HETERO LABS LTD UNIT III
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~HIKMA INTL PHARMS~150MG~A~07624
3~002~AB~Feb 24, 2003~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~HIKMA INTL PHARMS~300MG~A~07624
3~001~AB~Jun 27, 2002~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~HIKMA PHARMS LLC~600MG~A~078763
~001~~Apr 15, 2008~No~DISCN~HIKMA PHARMACEUTICALS LLC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~ROXANE~150MG~N~017812~002~AB~Ja
n 28, 1987~No~RX~ROXANE LABORATORIES INC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~ROXANE~300MG~N~017812~001~AB~Ap
proved Prior to Jan 1, 1982~No~RX~ROXANE LABORATORIES INC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~ROXANE~600MG~N~017812~003~AB~Ja
n 28, 1987~Yes~RX~ROXANE LABORATORIES INC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~USL PHARMA~300MG~A~072542~001~~
Feb 1, 1989~No~DISCN~USL PHARMA INC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHIUM CARBONATE~WATSON LABS~300MG~A~070407~001~
~Mar 19, 1987~No~DISCN~WATSON LABORATORIES INC
LITHIUM CARBONATE~CAPSULE;ORAL~LITHONATE~SOLVAY~300MG~N~016782~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
ETODOLAC~CAPSULE;ORAL~LODINE~WYETH PHARMS INC~200MG~N~018922~002~~Jan 31, 1991~N
o~DISCN~WYETH PHARMACEUTICALS INC
ETODOLAC~CAPSULE;ORAL~LODINE~WYETH PHARMS INC~300MG~N~018922~003~~Jan 31, 1991~N
o~DISCN~WYETH PHARMACEUTICALS INC
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~LOPERAMIDE HYDROCHLORIDE~BANNER LIFE SCIEN
CES~1MG~N~021855~001~~Aug 4, 2005~No~OTC~BANNER LIFE SCIENCES LLC
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~LOPERAMIDE HYDROCHLORIDE~BANNER LIFE SCIEN
CES~2MG~N~021855~002~~Aug 4, 2005~Yes~OTC~BANNER LIFE SCIENCES LLC
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~LOPERAMIDE HYDROCHLORIDE~MYLAN~2MG~A~07274
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~LOPERAMIDE HYDROCHLORIDE~ROXANE~2MG~A~0730
80~001~~Nov 27, 1991~No~DISCN~ROXANE LABORATORIES INC
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~LOPERAMIDE HYDROCHLORIDE~SANDOZ~2MG~A~0729
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~LOPERAMIDE HYDROCHLORIDE~TEVA~2MG~A~073122
~001~~Aug 30, 1991~No~DISCN~TEVA PHARMACEUTICALS USA INC
LOPERAMIDE HYDROCHLORIDE~CAPSULE;ORAL~LOPERAMIDE HYDROCHLORIDE~TEVA~2MG~A~073192
~001~AB~Apr 30, 1992~No~RX~TEVA PHARMACEUTICALS USA INC
GEMFIBROZIL~CAPSULE;ORAL~LOPID~PFIZER PHARMS~200MG~N~018422~001~~Approved Prior
to Jan 1, 1982~No~DISCN~PFIZER PHARMACEUTICALS LTD
GEMFIBROZIL~CAPSULE;ORAL~LOPID~PFIZER PHARMS~300MG~N~018422~002~~Approved Prior
to Jan 1, 1982~No~DISCN~PFIZER PHARMACEUTICALS LTD
CHLORTHALIDONE; METOPROLOL TARTRATE~CAPSULE;ORAL~LOPRESSIDONE~NOVARTIS~25MG;100M
G~N~019451~001~~Dec 31, 1987~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
CHLORTHALIDONE; METOPROLOL TARTRATE~CAPSULE;ORAL~LOPRESSIDONE~NOVARTIS~25MG;200M

G~N~019451~002~~Dec 31, 1987~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
LORACARBEF~CAPSULE;ORAL~LORABID~KING PHARMS~200MG~N~050668~001~~Dec 31, 1991~No~
DISCN~KING PHARMACEUTICALS INC
LORACARBEF~CAPSULE;ORAL~LORABID~KING PHARMS~400MG~N~050668~002~~Apr 5, 1996~No~D
ISCN~KING PHARMACEUTICALS INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~CAPSULE;ORAL~LORCET-HD~MALLINCKRODT~500MG;
5MG~A~087336~001~~Jul 8, 1982~No~DISCN~MALLINCKRODT CHEMICAL INC
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE~CAPSULE;ORAL~LOTREL~NOVARTIS~EQ 2.
5MG BASE;10MG~N~020364~002~AB~Mar 3, 1995~No~RX~NOVARTIS PHARMACEUTICALS CORP
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE~CAPSULE;ORAL~LOTREL~NOVARTIS~EQ 5M
G BASE;10MG~N~020364~003~AB~Mar 3, 1995~No~RX~NOVARTIS PHARMACEUTICALS CORP
G BASE;20MG~N~020364~004~AB~Mar 3, 1995~No~RX~NOVARTIS PHARMACEUTICALS CORP
G BASE;40MG~N~020364~007~AB~Apr 11, 2006~No~RX~NOVARTIS PHARMACEUTICALS CORP
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE~CAPSULE;ORAL~LOTREL~NOVARTIS~EQ 10
MG BASE;20MG~N~020364~005~AB~Jun 20, 2002~No~RX~NOVARTIS PHARMACEUTICALS CORP
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE~CAPSULE;ORAL~LOTREL~NOVARTIS~EQ 10
MG BASE;40MG~N~020364~006~AB~Apr 11, 2006~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
OMEGA-3-ACID ETHYL ESTERS~CAPSULE;ORAL~LOVAZA~SMITHKLINE BEECHAM~1GM CONTAINS AT
LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS~N~021654~001~AB~Nov 10,
2004~Yes~RX~SMITHKLINE BEECHAM
LOXAPINE SUCCINATE~CAPSULE;ORAL~LOXAPINE SUCCINATE~LANNETT HOLDINGS INC~EQ 5MG B
ASE~A~090695~001~AB~Sep 26, 2011~No~RX~LANNETT HOLDINGS INC
LOXAPINE SUCCINATE~CAPSULE;ORAL~LOXAPINE SUCCINATE~LANNETT HOLDINGS INC~EQ 10MG
BASE~A~090695~002~AB~Sep 26, 2011~No~RX~LANNETT HOLDINGS INC
LOXAPINE SUCCINATE~CAPSULE;ORAL~LOXAPINE SUCCINATE~MIKAH PHARMA~EQ 5MG BASE~A~07
6868~001~AB~Aug 4, 2005~No~RX~MIKAH PHARMA LLC
LOXAPINE SUCCINATE~CAPSULE;ORAL~LOXAPINE SUCCINATE~MYLAN~EQ 5MG BASE~A~076762~00
1~AB~Nov 1, 2004~No~RX~MYLAN PHARMACEUTICALS INC
LOXAPINE SUCCINATE~CAPSULE;ORAL~LOXAPINE SUCCINATE~WATSON LABS~EQ 5MG BASE~A~072
204~001~AB~Jun 15, 1988~No~RX~WATSON LABORATORIES INC
2206~001~AB~Jun 15, 1988~Yes~RX~WATSON LABORATORIES INC
LOXAPINE SUCCINATE~CAPSULE;ORAL~LOXITANE~WATSON LABS~EQ 5MG BASE~N~017525~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
LOXAPINE SUCCINATE~CAPSULE;ORAL~LOXITANE~WATSON LABS~EQ 10MG BASE~N~017525~002~~
Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC

CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~LYGEN~ALRA~5MG~A~085107~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~LYGEN~ALRA~10MG~A~085009~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
CHLORDIAZEPOXIDE HYDROCHLORIDE~CAPSULE;ORAL~LYGEN~ALRA~25MG~A~085108~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
OLAPARIB~CAPSULE;ORAL~LYNPARZA~ASTRAZENECA PHARMS~50MG~N~206162~001~~Dec 19, 201
4~No~RX~ASTRAZENECA PHARMACEUTICALS LP
PREGABALIN~CAPSULE;ORAL~LYRICA~PF PRISM CV~25MG~N~021446~001~AB~Dec 30, 2004~No~
RX~PF PRISM CV
RX~PF PRISM CV
RX~PF PRISM CV
PREGABALIN~CAPSULE;ORAL~LYRICA~PF PRISM CV~100MG~N~021446~004~AB~Dec 30, 2004~No
~RX~PF PRISM CV
~RX~PF PRISM CV
~RX~PF PRISM CV
~RX~PF PRISM CV
PREGABALIN~CAPSULE;ORAL~LYRICA~PF PRISM CV~300MG~N~021446~008~AB~Dec 30, 2004~Ye
s~RX~PF PRISM CV
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~MACROBID~ALVOGEN I
NC~75MG;25MG~N~020064~001~AB~Dec 24, 1991~Yes~RX~ALVOGEN INC
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~MACRODANTIN~ALVOGEN INC~25MG~N~016
620~003~~Approved Prior to Jan 1, 1982~No~RX~ALVOGEN INC
620~001~AB~Approved Prior to Jan 1, 1982~No~RX~ALVOGEN INC
6620~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~ALVOGEN INC
DRONABINOL~CAPSULE;ORAL~MARINOL~ABBVIE~2.5MG~N~018651~001~AB~May 31, 1985~No~RX~
ABBVIE INC
DRONABINOL~CAPSULE;ORAL~MARINOL~ABBVIE~5MG~N~018651~002~AB~May 31, 1985~Yes~RX~A
BBVIE INC
DRONABINOL~CAPSULE;ORAL~MARINOL~ABBVIE~10MG~N~018651~003~AB~May 31, 1985~No~RX~A
BBVIE INC
PROCARBAZINE HYDROCHLORIDE~CAPSULE;ORAL~MATULANE~SIGMA TAU~EQ 50MG BASE~N~016785
~001~~Approved Prior to Jan 1, 1982~Yes~RX~SIGMA TAU PHARMACEUTICALS INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLODIUM~QUANTUM PHARMICS~EQ 50MG BASE~A~0713
80~001~~Jul 14, 1987~No~DISCN~QUANTUM PHARMICS LTD
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLODIUM~QUANTUM PHARMICS~EQ 100MG BASE~A~071
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~AM THERAP~EQ 50MG BASE~A~
071362~001~~Feb 10, 1987~No~DISCN~AMERICAN THERAPEUTICS INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~AM THERAP~EQ 100MG BASE~A
~071363~001~~Feb 10, 1987~No~DISCN~AMERICAN THERAPEUTICS INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~BARR~EQ 50MG BASE~A~07284
8~001~~Mar 20, 1989~No~DISCN~BARR LABORATORIES INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~BARR~EQ 100MG BASE~A~0728
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~MYLAN~EQ 50MG BASE~A~0710
81~002~~Sep 3, 1986~No~RX~MYLAN PHARMACEUTICALS INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~MYLAN~EQ 100MG BASE~A~071
081~001~~Sep 3, 1986~Yes~RX~MYLAN PHARMACEUTICALS INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~PAR PHARM~EQ 50MG BASE~A~

MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~PAR PHARM~EQ 100MG BASE~A
~072078~001~~Mar 10, 1988~No~DISCN~PAR PHARMACEUTICAL INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~SANDOZ~EQ 50MG BASE~A~072
262~001~~Nov 29, 1988~No~DISCN~SANDOZ INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~SANDOZ~EQ 100MG BASE~A~07
2263~001~~Nov 29, 1988~No~DISCN~SANDOZ INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~USL PHARMA~EQ 50MG BASE~A
~071007~001~~Mar 25, 1988~No~DISCN~USL PHARMA INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~USL PHARMA~EQ 100MG BASE~
A~071008~001~~Mar 25, 1988~No~DISCN~USL PHARMA INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~VITARINE~EQ 50MG BASE~A~0
71710~001~~Jun 15, 1988~No~DISCN~VITARINE PHARMACEUTICALS INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~VITARINE~EQ 100MG BASE~A~
071684~001~~Jun 15, 1988~No~DISCN~VITARINE PHARMACEUTICALS INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~WATSON LABS~EQ 50MG BASE~
A~071468~001~~Apr 15, 1987~No~DISCN~WATSON LABORATORIES INC
A~071640~001~~Aug 11, 1987~No~DISCN~WATSON LABORATORIES INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOFENAMATE SODIUM~WATSON LABS~EQ 100MG BASE
~A~070401~001~~Nov 25, 1986~No~DISCN~WATSON LABORATORIES INC
~A~071469~001~~Apr 15, 1987~No~DISCN~WATSON LABORATORIES INC
~A~071641~001~~Aug 11, 1987~No~DISCN~WATSON LABORATORIES INC
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOMEN~PARKE DAVIS~EQ 50MG BASE~N~018006~001
~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
MECLOFENAMATE SODIUM~CAPSULE;ORAL~MECLOMEN~PARKE DAVIS~EQ 100MG BASE~N~018006~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~MEDIGESIC PLUS~US CHEM~325MG;50
MG;40MG~A~089115~001~~Jan 14, 1986~No~DISCN~US CHEMICAL MARKETING GROUP INC
MEFENAMIC ACID~CAPSULE;ORAL~MEFENAMIC ACID~BRECKENRIDGE PHARM~250MG~A~090359~001
~AB~Feb 5, 2013~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
MEFENAMIC ACID~CAPSULE;ORAL~MEFENAMIC ACID~LUPIN LTD~250MG~A~091322~001~AB~Jul 2
MEFENAMIC ACID~CAPSULE;ORAL~MEFENAMIC ACID~MICRO LABS LTD~250MG~A~090562~001~AB~
Nov 19, 2010~No~RX~MICRO LABS LTD
MEFENAMIC ACID~CAPSULE;ORAL~MEFENAMIC ACID~VINTAGE PHARMS LLC~250MG~A~091608~001
~AB~Jun 2, 2014~No~RX~VINTAGE PHARMACEUTICALS LLC
SIBUTRAMINE HYDROCHLORIDE~CAPSULE;ORAL~MERIDIA~ABBOTT~5MG~N~020632~001~~Nov 22,
1997~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
METHOXSALEN~CAPSULE;ORAL~METHOXSALEN~SANDOZ~10MG~A~087781~001~~Jun 8, 1982~No~DI
SCN~SANDOZ INC
METHOXSALEN~CAPSULE;ORAL~METHOXSALEN~STRIDES PHARMA~10MG~A~202687~001~AB~Jun 5,
METHYLTESTOSTERONE~CAPSULE;ORAL~METHYLTESTOSTERONE~HEATHER~10MG~A~084967~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
METYRAPONE~CAPSULE;ORAL~METOPIRONE~HRA PHARMA~250MG~N~012911~002~~Aug 9, 1996~Ye
s~RX~HRA PHARMA LLC
METRONIDAZOLE~CAPSULE;ORAL~METRONIDAZOLE~ABLE~375MG~A~076505~001~~Nov 13, 2003~N
o~DISCN~ABLE LABORATORIES INC
METRONIDAZOLE~CAPSULE;ORAL~METRONIDAZOLE~ALEMBIC LTD~375MG~A~079065~001~AB~Jun 2
3, 2009~No~RX~ALEMBIC LTD
METRONIDAZOLE~CAPSULE;ORAL~METRONIDAZOLE~PAR PHARM~375MG~A~076522~001~AB~Jan 29,

MEXILETINE HYDROCHLORIDE~CAPSULE;ORAL~MEXILETINE HYDROCHLORIDE~SANDOZ~150MG~A~07
MEXILETINE HYDROCHLORIDE~CAPSULE;ORAL~MEXILETINE HYDROCHLORIDE~TEVA~150MG~A~0743
77~001~~May 16, 1995~No~RX~TEVA PHARMACEUTICALS USA INC
77~002~~May 16, 1995~No~RX~TEVA PHARMACEUTICALS USA INC
77~003~~May 16, 1995~Yes~RX~TEVA PHARMACEUTICALS USA INC
MEXILETINE HYDROCHLORIDE~CAPSULE;ORAL~MEXILETINE HYDROCHLORIDE~WATSON LABS~150MG
~A~074711~001~~Feb 26, 1997~No~DISCN~WATSON LABORATORIES INC
MEXILETINE HYDROCHLORIDE~CAPSULE;ORAL~MEXITIL~BOEHRINGER INGELHEIM~150MG~N~01887
3~002~~Dec 30, 1985~No~DISCN~BOEHRINGER INGELHEIM
HYDROCHLOROTHIAZIDE~CAPSULE;ORAL~MICROZIDE~ACTAVIS LABS UT INC~12.5MG~N~020504~0
01~AB~Dec 27, 1996~Yes~RX~ACTAVIS LABORATORIES UT INC
IBUPROFEN~CAPSULE;ORAL~MIDOL~BAYER~200MG **Federal Register determination that p
roduct was not discontinued or withdrawn for safety or efficacy reasons**~A~0706
26~001~~Sep 2, 1987~No~DISCN~BAYER HEALTHCARE LLC
IBUPROFEN~CAPSULE;ORAL~MIDOL~BAYER~200MG **Federal Register determination that p
roduct was not discontinued or withdrawn for safety or efficacy reasons**~A~0710
02~001~~Sep 2, 1987~No~DISCN~BAYER HEALTHCARE LLC
IBUPROFEN~CAPSULE;ORAL~MIDOL LIQUID GELS~BANNER LIFE SCIENCES~200MG~N~021472~001
~~Oct 18, 2002~Yes~OTC~BANNER LIFE SCIENCES LLC
PHENSUXIMIDE~CAPSULE;ORAL~MILONTIN~PARKE DAVIS~500MG~N~008855~004~~Approved Prio
r to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~MINIPRESS~PFIZER~EQ 1MG BASE~N~017442~002~AB
~Approved Prior to Jan 1, 1982~No~RX~PFIZER LABORATORIES DIV PFIZER INC
~Approved Prior to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC
~Approved Prior to Jan 1, 1982~No~RX~PFIZER LABORATORIES DIV PFIZER INC
POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~MINIZIDE~PFIZER~0.5MG;EQ 1MG B
ASE~N~017986~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCIN~PRECISION DERMAT~EQ 50MG BASE~N~0
50649~001~AB~May 31, 1990~No~RX~PRECISION DERMATOLOGY INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCIN~PRECISION DERMAT~EQ 75MG BASE~N~0
50649~003~~Feb 12, 2001~No~DISCN~PRECISION DERMATOLOGY INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCIN~PRECISION DERMAT~EQ 100MG BASE~N~
050649~002~AB~May 31, 1990~No~RX~PRECISION DERMATOLOGY INC

MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCIN~TRIAX PHARMS~EQ 50MG BASE~N~05031
5~002~~Approved Prior to Jan 1, 1982~No~DISCN~TRIAX PHARMACEUTICALS LLC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCIN~TRIAX PHARMS~EQ 100MG BASE~N~0503
15~001~~Approved Prior to Jan 1, 1982~No~DISCN~TRIAX PHARMACEUTICALS LLC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~AUROBINDO PHARM
A~EQ 50MG BASE~A~065470~001~AB~Mar 11, 2008~No~RX~AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~IMPAX LABS~EQ 5
0MG BASE~A~065005~001~AB~Mar 23, 1999~No~RX~IMPAX LABORATORIES INC
5MG BASE~A~065005~003~AB~Apr 18, 2001~No~RX~IMPAX LABORATORIES INC
00MG BASE~A~065005~002~AB~Mar 23, 1999~No~RX~IMPAX LABORATORIES INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~RANBAXY~EQ 50MG
BASE~A~065062~001~AB~Nov 30, 2000~No~RX~RANBAXY LABORATORIES LTD
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~RANBAXY~EQ 75MG
BASE~A~065062~002~AB~Nov 30, 2000~No~RX~RANBAXY LABORATORIES LTD
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~RANBAXY~EQ 100M
G BASE~A~065062~003~AB~Nov 30, 2000~No~RX~RANBAXY LABORATORIES LTD
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~SUN PHARM INDS
INC~EQ 50MG BASE~A~090867~001~AB~May 13, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIE
S INC
INC~EQ 75MG BASE~A~090867~002~AB~May 13, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIE
S INC
INC~EQ 100MG BASE~A~090867~003~AB~May 13, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRI
ES INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~TEVA~EQ 50MG BA
SE~A~063011~001~AB~Mar 2, 1992~No~RX~TEVA PHARMACEUTICALS USA INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~TEVA~EQ 75MG BA
SE~A~063009~002~AB~Aug 12, 2003~No~RX~TEVA PHARMACEUTICALS USA INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~TEVA~EQ 100MG B
ASE~A~063009~001~AB~Mar 2, 1992~Yes~RX~TEVA PHARMACEUTICALS USA INC
MINOCYCLINE HYDROCHLORIDE~CAPSULE;ORAL~MINOCYCLINE HYDROCHLORIDE~WATSON LABS~EQ
50MG BASE~A~063181~001~AB~Dec 30, 1991~No~RX~WATSON LABORATORIES INC
75MG BASE~A~063065~002~AB~Jun 10, 1999~No~RX~WATSON LABORATORIES INC
100MG BASE~A~063065~001~AB~Dec 30, 1991~No~RX~WATSON LABORATORIES INC
COLCHICINE~CAPSULE;ORAL~MITIGARE~HIKMA INTL PHARMS~0.6MG~N~204820~001~~Sep 26, 2
014~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
MOLINDONE HYDROCHLORIDE~CAPSULE;ORAL~MOBAN~ENDO PHARMS~5MG **Federal Register de
y reasons**~N~017111~001~~Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUT
ICALS INC
MOLINDONE HYDROCHLORIDE~CAPSULE;ORAL~MOBAN~ENDO PHARMS~10MG **Federal Register d
etermination that product was not discontinued or withdrawn for safety or effica
cy reasons**~N~017111~002~~Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEU
TICALS INC
MOLINDONE HYDROCHLORIDE~CAPSULE;ORAL~MOBAN~ENDO PHARMS~25MG **Federal Register d
TICALS INC
TRILOSTANE~CAPSULE;ORAL~MODRASTANE~BIOENVISION~30MG~N~018719~002~~Dec 31, 1984~N
o~DISCN~BIOENVISION INC
TRILOSTANE~CAPSULE;ORAL~MODRASTANE~BIOENVISION~60MG~N~018719~001~~Dec 31, 1984~N

o~DISCN~BIOENVISION INC
DOXYCYCLINE~CAPSULE;ORAL~MONODOX~AQUA PHARMS~EQ 50MG BASE~N~050641~002~AB~Feb 10
, 1992~No~RX~AQUA PHARMACEUTICALS
DOXYCYCLINE~CAPSULE;ORAL~MONODOX~AQUA PHARMS~EQ 75MG BASE~N~050641~003~AB~Oct 18
, 2006~No~RX~AQUA PHARMACEUTICALS
DOXYCYCLINE~CAPSULE;ORAL~MONODOX~AQUA PHARMS~EQ 100MG BASE~N~050641~001~AB~Dec 2
9, 1989~Yes~RX~AQUA PHARMACEUTICALS
RIFABUTIN~CAPSULE;ORAL~MYCOBUTIN~PHARMACIA AND UPJOHN~150MG~N~050689~001~AB~Dec
23, 1992~Yes~RX~PHARMACIA AND UPJOHN CO
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~ACCORD HLTHCARE~250MG~A
~090253~001~AB~May 4, 2009~No~RX~ACCORD HEALTHCARE INC
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~ALKEM LABS LTD~250MG~A~
200197~001~AB~Jun 13, 2013~No~RX~ALKEM LABORATORIES LTD
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~APOTEX CORP~250MG~A~090
419~001~AB~Apr 22, 2009~No~RX~APOTEX CORP
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~CADISTA PHARMS~250MG~A~
090762~001~AB~Dec 15, 2014~No~RX~CADISTA PHARMACEUTICALS INC
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~DR REDDYS LABS LTD~250M
G~A~091315~001~AB~Oct 27, 2011~No~RX~DR REDDYS LABORATORIES LTD
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~MYLAN~250MG~A~065520~00
1~AB~May 4, 2009~No~RX~MYLAN PHARMACEUTICALS INC
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~ROXANE~250MG~A~065410~0
01~AB~Jul 29, 2008~No~RX~ROXANE LABORATORIES INC
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~SANDOZ~250MG~A~065379~0
01~AB~Oct 15, 2008~No~RX~SANDOZ INC
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~STRIDES PHARMA~250MG~A~
090055~001~AB~Jun 10, 2010~No~RX~STRIDES PHARMA GLOBAL PTE LTD
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~TEVA PHARMS~250MG~A~065
491~001~AB~May 6, 2009~No~RX~TEVA PHARMACEUTICALS USA
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~VINTAGE PHARMS LLC~250M
G~A~090111~001~AB~Dec 22, 2009~No~RX~VINTAGE PHARMACEUTICALS LLC
MYCOPHENOLATE MOFETIL~CAPSULE;ORAL~MYCOPHENOLATE MOFETIL~ZYDUS PHARMS USA INC~25
0MG~A~065433~001~~May 4, 2009~No~DISCN~ZYDUS PHARMACEUTICALS USA INC
ISOTRETINOIN~CAPSULE;ORAL~MYORISAN~DOUGLAS PHARMS~10MG~A~076485~001~AB~Jan 19, 2
012~No~RX~DOUGLAS PHARMACEUTICALS AMERICA LTD
FENOPROFEN CALCIUM~CAPSULE;ORAL~NALFON~XSPIRE~EQ 200MG BASE~N~017604~003~~Approv
ed Prior to Jan 1, 1982~Yes~RX~XSPIRE LLC
FENOPROFEN CALCIUM~CAPSULE;ORAL~NALFON~XSPIRE~EQ 300MG BASE~N~017604~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~XSPIRE LLC
FENOPROFEN CALCIUM~CAPSULE;ORAL~NALFON~XSPIRE~EQ 400MG BASE~N~017604~004~~Jul 21
, 2009~No~RX~XSPIRE LLC
NAPROXEN SODIUM~CAPSULE;ORAL~NAPROXEN SODIUM~BANNER LIFE SCIENCES~EQ 200MG BASE~
N~021920~001~~Feb 17, 2006~Yes~OTC~BANNER LIFE SCIENCES LLC
NAPROXEN SODIUM~CAPSULE;ORAL~NAPROXEN SODIUM~CATALENT~EQ 200MG BASE~A~202807~001
~~Feb 13, 2015~No~OTC~CATALENT PHARMA SOLUTIONS LLC
THIOTHIXENE~CAPSULE;ORAL~NAVANE~PFIZER~1MG~N~016584~001~AB~Approved Prior to Jan
1, 1982~No~RX~PFIZER INC
1, 1982~Yes~RX~PFIZER INC
THIOTHIXENE~CAPSULE;ORAL~NAVANE~PFIZER~10MG~N~016584~004~AB~Approved Prior to Ja
n 1, 1982~No~RX~PFIZER INC
THIOTHIXENE~CAPSULE;ORAL~NAVANE~PFIZER~20MG~N~016584~005~~Approved Prior to Jan
1, 1982~No~DISCN~PFIZER INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~NEMBUTAL SODIUM~OAK PHARMS~30MG~A~084095~001~~

Approved Prior to Jan 1, 1982~No~DISCN~OAK PHARMACEUTICALS INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~NEMBUTAL SODIUM~OAK PHARMS~50MG~A~084093~001~~
Approved Prior to Jan 1, 1982~No~DISCN~OAK PHARMACEUTICALS INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~NEMBUTAL SODIUM~OAK PHARMS~100MG~A~083245~001~
~Approved Prior to Jan 1, 1982~No~DISCN~OAK PHARMACEUTICALS INC
CYCLOSPORINE~CAPSULE;ORAL~NEORAL~NOVARTIS~25MG~N~050715~001~AB1~Jul 14, 1995~No~
RX~NOVARTIS PHARMACEUTICALS CORP
CYCLOSPORINE~CAPSULE;ORAL~NEORAL~NOVARTIS~50MG~N~050715~003~~Jul 14, 1995~No~DIS
CN~NOVARTIS PHARMACEUTICALS CORP
CYCLOSPORINE~CAPSULE;ORAL~NEORAL~NOVARTIS~100MG~N~050715~002~AB1~Jul 14, 1995~Ye
s~RX~NOVARTIS PHARMACEUTICALS CORP
GABAPENTIN~CAPSULE;ORAL~NEURONTIN~PFIZER PHARMS~100MG~N~020235~001~AB~Dec 30, 19
93~No~RX~PFIZER PHARMACEUTICALS LTD
93~No~RX~PFIZER PHARMACEUTICALS LTD
93~Yes~RX~PFIZER PHARMACEUTICALS LTD
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~NICARDIPINE HYDROCHLORIDE~ANI PHARMS INC~
20MG~A~074439~001~AB~Dec 10, 1996~No~RX~ANI PHARMACEUTICALS INC
20MG~A~074540~001~AB~Oct 28, 1996~No~RX~ANI PHARMACEUTICALS INC
30MG~A~074439~002~AB~Dec 10, 1996~No~RX~ANI PHARMACEUTICALS INC
30MG~A~074540~002~AB~Oct 28, 1996~No~RX~ANI PHARMACEUTICALS INC
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~NICARDIPINE HYDROCHLORIDE~EPIC PHARMA~20M
G~A~074928~001~AB~Mar 19, 1998~No~RX~EPIC PHARMA INC
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~NICARDIPINE HYDROCHLORIDE~EPIC PHARMA~30M
G~A~074928~002~AB~Mar 19, 1998~No~RX~EPIC PHARMA INC
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~NICARDIPINE HYDROCHLORIDE~MYLAN~20MG~A~07
4642~001~AB~Jul 18, 1996~No~RX~MYLAN PHARMACEUTICALS INC
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~NICARDIPINE HYDROCHLORIDE~MYLAN~30MG~A~07
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~NICARDIPINE HYDROCHLORIDE~WATSON LABS~20M
G~A~074670~001~~Oct 28, 1996~No~DISCN~WATSON LABORATORIES INC
NICARDIPINE HYDROCHLORIDE~CAPSULE;ORAL~NICARDIPINE HYDROCHLORIDE~WATSON LABS~30M
G~A~074670~002~~Oct 28, 1996~No~DISCN~WATSON LABORATORIES INC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~ACTAVIS ELIZABETH~10MG~A~072579~001~AB~Jan 8,
1991~No~RX~ACTAVIS ELIZABETH LLC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~ACTAVIS ELIZABETH~20MG~A~072556~001~AB~Sep 20
, 1990~No~RX~ACTAVIS ELIZABETH LLC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~CATALENT~10MG~A~073250~001~~Oct 8, 1991~No~DI
SCN~CATALENT PHARMA SOLUTIONS LLC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~CATALENT~20MG~A~074045~001~~Apr 30, 1992~No~D
ISCN~CATALENT PHARMA SOLUTIONS LLC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~CHASE LABS NJ~10MG~A~072409~001~~Jul 4, 1990~
No~DISCN~CHASE LABORATORIES INC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~CHASE LABS NJ~20MG~A~073421~001~~Jun 19, 1991
~No~DISCN~CHASE LABORATORIES INC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~EMCURE PHARMS USA~10MG~A~202644~001~AB~Apr 25
, 2013~No~RX~EMCURE PHARMACEUTICALS USA INC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~EMCURE PHARMS USA~20MG~A~202644~002~AB~Apr 25
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~INTERGEL PHARM~10MG~A~072781~001~AB~Jul 30, 1
993~No~RX~INTERGEL PHARMACEUTICAL INC
NIFEDIPINE~CAPSULE;ORAL~NIFEDIPINE~TEVA~10MG~A~072651~001~~Feb 19, 1992~No~DISCN
NIMODIPINE~CAPSULE;ORAL~NIMODIPINE~BANNER LIFE SCIENCES~30MG~A~076740~001~AB~Jan
17, 2008~Yes~RX~BANNER LIFE SCIENCES LLC
NIMODIPINE~CAPSULE;ORAL~NIMODIPINE~BARR LABS INC~30MG~A~077811~001~AB~May 2, 200

7~No~RX~BARR LABORATORIES INC
NIMODIPINE~CAPSULE;ORAL~NIMODIPINE~SUN PHARM INDS INC~30MG~A~077067~001~AB~Apr 1
7, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
NIMODIPINE~CAPSULE;ORAL~NIMODIPINE~THEPHARMANETWORK LLC~30MG~A~090103~001~AB~Apr
7, 2014~No~RX~THEPHARMANETWORK LLC
NIMODIPINE~CAPSULE;ORAL~NIMOTOP~BAYER PHARMS~30MG **Federal Register determinati
on that product was not discontinued or withdrawn for safety or efficacy reasons
**~N~018869~001~~Dec 28, 1988~No~DISCN~BAYER PHARMACEUTICALS CORP
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN~IVAX SUB TEVA PHARM
S~50MG~A~073671~001~AB~Jan 28, 1993~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHAR
MACEUTICALS USA
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN~IVAX SUB TEVA PHARM
S~100MG~A~073652~001~AB~Jan 28, 1993~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHA
RMACEUTICALS USA
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN~MYLAN~50MG~A~074967
~001~AB~Jul 9, 1997~No~RX~MYLAN PHARMACEUTICALS INC
7~002~~Jul 9, 1997~No~DISCN~MYLAN PHARMACEUTICALS INC
5~001~AB~Aug 18, 2004~No~RX~MYLAN PHARMACEUTICALS INC
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN~SANDOZ~25MG~A~07433
6~001~~Jan 25, 1995~No~DISCN~SANDOZ INC
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN~WATSON LABS~25MG~A~
073696~001~~Dec 31, 1992~No~DISCN~WATSON LABORATORIES INC
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN~WATSON LABS~50MG~A~
NITROFURANTOIN~CAPSULE;ORAL~NITROFURANTOIN~WATSON LABS~50MG~A~084326~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN~WATSON LABS~100MG~A
~073696~003~~Dec 31, 1992~No~DISCN~WATSON LABORATORIES INC
NITROFURANTOIN~CAPSULE;ORAL~NITROFURANTOIN~WATSON LABS~100MG~A~084326~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN (MO
NOHYDRATE/MACROCRYSTALS)~MYLAN~75MG;25MG~A~076648~001~AB~Mar 22, 2004~No~RX~MYLA
N PHARMACEUTICALS INC
NOHYDRATE/MACROCRYSTALS)~RANBAXY LABS LTD~75MG;25MG~A~076951~001~~Mar 30, 2005~N
o~DISCN~RANBAXY LABORATORIES LTD
NOHYDRATE/MACROCRYSTALS)~SANDOZ~75MG;25MG~A~077066~001~AB~Apr 5, 2005~No~RX~SAND
OZ INC
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN MACROCRYSTALLINE~WA
TSON LABS~50MG~A~070248~001~~Jun 24, 1988~No~DISCN~WATSON LABORATORIES INC
NITROFURANTOIN, MACROCRYSTALLINE~CAPSULE;ORAL~NITROFURANTOIN MACROCRYSTALLINE~WA
TSON LABS~100MG~A~070249~001~~Jun 24, 1988~No~DISCN~WATSON LABORATORIES INC
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~ANI PHARMS INC~150MG~A~075461~001~~Jul 8, 200
2~No~DISCN~ANI PHARMACEUTICALS INC
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~ANI PHARMS INC~150MG~A~075668~001~AB~Sep 12,
2002~No~RX~ANI PHARMACEUTICALS INC
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~ANI PHARMS INC~300MG~A~075461~002~~Jul 8, 200
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~ANI PHARMS INC~300MG~A~075668~002~AB~Sep 12,
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~APOTEX INC~150MG~A~076383~001~~Jan 23, 2003~N
o~DISCN~APOTEX INC
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~APOTEX INC~300MG~A~076383~002~~Jan 23, 2003~N

o~DISCN~APOTEX INC
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~DR REDDYS LABS LTD~150MG~A~077314~001~AB~Sep
15, 2005~No~RX~DR REDDYS LABORATORIES LTD
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~DR REDDYS LABS LTD~300MG~A~077314~002~AB~Sep
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~GLENMARK GENERICS~150MG~A~090618~001~AB~Jul 1
5, 2011~No~RX~GLENMARK GENERICS INC USA
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~GLENMARK GENERICS~300MG~A~090618~002~AB~Jul 1
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~MYLAN PHARMS INC~150MG~A~075806~001~AB~Jul 5,
2002~No~RX~MYLAN PHARMACEUTICALS INC.
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~MYLAN PHARMS INC~150MG~A~075934~001~~Jul 9, 2
002~No~DISCN~MYLAN PHARMACEUTICALS INC.
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~MYLAN PHARMS INC~300MG~A~075806~002~AB~Jul 5,
2002~Yes~RX~MYLAN PHARMACEUTICALS INC.
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~MYLAN PHARMS INC~300MG~A~075934~002~~Jul 9, 2
002~No~DISCN~MYLAN PHARMACEUTICALS INC.
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~SANDOZ~150MG~A~076178~001~AB~Jul 5, 2002~No~R
X~SANDOZ INC
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~SANDOZ~300MG~A~076178~002~AB~Jul 5, 2002~No~R
X~SANDOZ INC
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~WATSON LABS~150MG~A~075616~001~AB~Jul 9, 2002
NIZATIDINE~CAPSULE;ORAL~NIZATIDINE~WATSON LABS~300MG~A~075616~002~AB~Jul 9, 2002
METHYPRYLON~CAPSULE;ORAL~NOLUDAR~ROCHE~300MG~N~009660~008~~Approved Prior to Jan
1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~CAPSULE;ORAL~NORETHINDRONE ACETATE AND
ETHINYL ESTRADIOL AND FERROUS FUMARATE~WARNER CHILCOTT~0.02MG;1MG~N~204426~001~~
Apr 19, 2013~No~DISCN~WARNER CHILCOTT CO INC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~NORPACE~GD SEARLE LLC~EQ 100MG BASE~N~017447
~001~AB~Approved Prior to Jan 1, 1982~No~RX~GD SEARLE LLC
DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~NORPACE~GD SEARLE LLC~EQ 150MG BASE~N~017447
~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~GD SEARLE LLC
DROXIDOPA~CAPSULE;ORAL~NORTHERA~LUNDBECK NA LTD~100MG~N~203202~001~~Feb 18, 2014
~No~RX~LUNDBECK NA LTD
~No~RX~LUNDBECK NA LTD
~Yes~RX~LUNDBECK NA LTD
NORTRIPTYLINE HYDROCHLORIDE~CAPSULE;ORAL~NORTRIPTYLINE HYDROCHLORIDE~MYLAN~EQ 10
MG BASE~A~074234~001~AB~Jul 26, 1993~No~RX~MYLAN PHARMACEUTICALS INC
NORTRIPTYLINE HYDROCHLORIDE~CAPSULE;ORAL~NORTRIPTYLINE HYDROCHLORIDE~SANDOZ~EQ 1
0MG BASE~A~074054~001~~Dec 31, 1992~No~DISCN~SANDOZ INC
0MG BASE~A~074835~001~~Jun 30, 1997~No~DISCN~SANDOZ INC

NORTRIPTYLINE HYDROCHLORIDE~CAPSULE;ORAL~NORTRIPTYLINE HYDROCHLORIDE~TARO~EQ 10M
G BASE~A~075520~004~AB~May 8, 2000~No~RX~TARO PHARMACEUTICALS INC
NORTRIPTYLINE HYDROCHLORIDE~CAPSULE;ORAL~NORTRIPTYLINE HYDROCHLORIDE~TEVA~EQ 10M
G BASE~A~073667~001~~Apr 11, 1996~No~DISCN~TEVA PHARMACEUTICALS USA INC
G BASE~A~074132~001~AB~Mar 27, 1995~No~RX~TEVA PHARMACEUTICALS USA INC
NORTRIPTYLINE HYDROCHLORIDE~CAPSULE;ORAL~NORTRIPTYLINE HYDROCHLORIDE~WATSON LABS
~EQ 10MG BASE~A~073553~001~AB~Mar 30, 1992~No~RX~WATSON LABORATORIES INC
RITONAVIR~CAPSULE;ORAL~NORVIR~ABBOTT~100MG~N~020680~001~~Mar 1, 1996~No~DISCN~AB
BOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
RITONAVIR~CAPSULE;ORAL~NORVIR~ABBVIE~100MG~N~020945~001~~Jun 29, 1999~Yes~RX~ABB
VIE INC
LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS~CAPSULE;ORAL~NOVRAD~LILLY~EQ 50MG BASE~N~01
2928~006~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY INDUSTRIES INC
LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS~CAPSULE;ORAL~NOVRAD~LILLY~EQ 100MG BASE~N~0
12928~004~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY INDUSTRIES INC
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE~CAPSULE;ORAL~NUEDEXTA~AVANIR PH
ARMS~20MG;10MG~N~021879~001~~Oct 29, 2010~Yes~RX~AVANIR PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~OBESTIN-30~FERNDALE LABS~30MG~A~087144~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~OBY-TRIM~SHIRE RICHWOOD~30MG~A~087764~001
~~Mar 18, 1982~No~DISCN~SHIRE RICHWOOD INC
NINTEDANIB~CAPSULE;ORAL~OFEV~BOEHRINGER INGELHEIM~100MG~N~205832~001~~Oct 15, 20
14~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
NINTEDANIB~CAPSULE;ORAL~OFEV~BOEHRINGER INGELHEIM~150MG~N~205832~002~~Oct 15, 20
FLUOXETINE HYDROCHLORIDE; OLANZAPINE~CAPSULE;ORAL~OLANZAPINE AND FLUOXETINE HYDR
OCHLORIDE~PAR PHARM~EQ 25MG BASE;EQ 3MG BASE~A~077742~001~AB~Nov 2, 2012~No~RX~P
AR PHARMACEUTICAL INC
OCHLORIDE~PAR PHARM~EQ 25MG BASE;EQ 12MG BASE~A~077742~003~AB~Nov 2, 2012~No~RX~
PAR PHARMACEUTICAL INC
OCHLORIDE~PAR PHARM~EQ 50MG BASE;EQ 12MG BASE~A~077742~005~AB~Nov 2, 2012~No~RX~
OCHLORIDE~SANDOZ~EQ 25MG BASE;EQ 3MG BASE~A~078901~005~AB~Nov 16, 2012~No~RX~SAN
DOZ INC
DOZ INC
OCHLORIDE~SANDOZ~EQ 25MG BASE;EQ 12MG BASE~A~078901~003~AB~Nov 16, 2012~No~RX~SA
NDOZ INC
DOZ INC
OCHLORIDE~SANDOZ~EQ 50MG BASE;EQ 12MG BASE~A~078901~004~AB~Nov 16, 2012~No~RX~SA
NDOZ INC
OCHLORIDE~TEVA PHARMS~EQ 25MG BASE;EQ 3MG BASE~A~202074~001~AB~Mar 25, 2013~No~R
X~TEVA PHARMACEUTICALS USA
OCHLORIDE~TEVA PHARMS~EQ 25MG BASE;EQ 6MG BASE~A~077528~001~AB~Jun 19, 2012~No~R
OCHLORIDE~TEVA PHARMS~EQ 25MG BASE;EQ 12MG BASE~A~077528~002~AB~Jun 19, 2012~No~
OCHLORIDE~TEVA PHARMS~EQ 50MG BASE;EQ 6MG BASE~A~077528~003~AB~Jun 19, 2012~No~R
OCHLORIDE~TEVA PHARMS~EQ 50MG BASE;EQ 12MG BASE~A~077528~004~AB~Jun 19, 2012~No~
SIMEPREVIR SODIUM~CAPSULE;ORAL~OLYSIO~JANSSEN PRODS~EQ 150MG BASE~N~205123~001~~
Nov 22, 2013~Yes~RX~JANSSEN PRODUCTS LP
OMEGA-3-ACID ETHYL ESTERS~CAPSULE;ORAL~OMEGA-3-ACID ETHYL ESTERS~APOTEX INC~1GM
CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS~A~090973~001~
AB~Sep 30, 2014~No~RX~APOTEX INC
OMEGA-3-ACID ETHYL ESTERS~CAPSULE;ORAL~OMEGA-3-ACID ETHYL ESTERS~PAR PHARM INC~1
GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS~A~091018~0
01~AB~Jun 24, 2014~No~RX~PAR PHARMACEUTICAL INC
OMEGA-3-ACID ETHYL ESTERS~CAPSULE;ORAL~OMEGA-3-ACID ETHYL ESTERS~TEVA PHARMS USA
~1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS~A~091028
~001~AB~Apr 7, 2014~No~RX~TEVA PHARMACEUTICALS USA
OMEPRAZOLE; SODIUM BICARBONATE~CAPSULE;ORAL~OMEPRAZOLE AND SODIUM BICARBONATE~PA
R PHARM~20MG;1.1GM~A~078966~001~AB~May 25, 2010~No~RX~PAR PHARMACEUTICAL
OMEPRAZOLE; SODIUM BICARBONATE~CAPSULE;ORAL~OMEPRAZOLE AND SODIUM BICARBONATE~PA
R PHARM~40MG;1.1GM~A~078966~002~AB~May 25, 2010~No~RX~PAR PHARMACEUTICAL
CEFDINIR~CAPSULE;ORAL~OMNICEF~ABBVIE~300MG~N~050739~001~~Dec 4, 1997~No~DISCN~AB
BVIE INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~OMNIPEN (AMPICILLIN)~WYETH AYERST~
250MG~A~060624~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATO
RIES
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~OMNIPEN (AMPICILLIN)~WYETH AYERST~

RIES
OMEGA-3-ACID ETHYL ESTERS~CAPSULE;ORAL~OMTRYG~TRYGG~1.2GM CONTAINS AT LEAST 900M
G OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS~N~204977~001~~Apr 23, 2014~Yes~RX~T
RYGG PHARMA INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~ONA-MAST~MAST MM~30MG~A~086511~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~MM MAST AND CO
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~ONA-MAST~MAST MM~30MG~A~086516~001~~Appro
DOXYCYCLINE~CAPSULE;ORAL~ORACEA~GALDERMA LABS LP~40MG~N~050805~001~~May 26, 2006
~Yes~RX~GALDERMA LABORATORIES LP
IPODATE SODIUM~CAPSULE;ORAL~ORAGRAFIN SODIUM~BRACCO~500MG~N~012967~001~~Approved
NITISINONE~CAPSULE;ORAL~ORFADIN~SWEDISH ORPHAN~2MG~N~021232~001~~Jan 18, 2002~No
~RX~SWEDISH ORPHAN BIOVITRUM AB PUBL
NITISINONE~CAPSULE;ORAL~ORFADIN~SWEDISH ORPHAN~5MG~N~021232~002~~Jan 18, 2002~No
~RX~SWEDISH ORPHAN BIOVITRUM AB PUBL
NITISINONE~CAPSULE;ORAL~ORFADIN~SWEDISH ORPHAN~10MG~N~021232~003~~Jan 18, 2002~Y
es~RX~SWEDISH ORPHAN BIOVITRUM AB PUBL
KETOPROFEN~CAPSULE;ORAL~ORUDIS~WYETH AYERST~25MG~N~018754~001~~Jul 31, 1987~No~D
ISCN~WYETH AYERST LABORATORIES
KETOPROFEN~CAPSULE;ORAL~ORUDIS~WYETH AYERST~50MG~N~018754~002~~Jan 9, 1986~No~DI
SCN~WYETH AYERST LABORATORIES
KETOPROFEN~CAPSULE;ORAL~ORUDIS~WYETH AYERST~75MG~N~018754~003~~Jan 9, 1986~No~DI
SCN~WYETH AYERST LABORATORIES
OXACILLIN SODIUM~CAPSULE;ORAL~OXACILLIN SODIUM~APOTHECON~EQ 250MG BASE~A~061450~
002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUI
BB
OXACILLIN SODIUM~CAPSULE;ORAL~OXACILLIN SODIUM~APOTHECON~EQ 500MG BASE~A~061450~
BB
OXACILLIN SODIUM~CAPSULE;ORAL~OXACILLIN SODIUM~TEVA~EQ 250MG BASE~A~062222~001~~
Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
OXACILLIN SODIUM~CAPSULE;ORAL~OXACILLIN SODIUM~TEVA~EQ 500MG BASE~A~062222~002~~
OXAZEPAM~CAPSULE;ORAL~OXAZEPAM~ACTAVIS ELIZABETH~10MG~A~072251~001~AB~Apr 14, 19
88~Yes~RX~ACTAVIS ELIZABETH LLC
OXAZEPAM~CAPSULE;ORAL~OXAZEPAM~AM THERAP~10MG~A~071955~001~~Mar 3, 1988~No~DISCN
OXAZEPAM~CAPSULE;ORAL~OXAZEPAM~IVAX SUB TEVA PHARMS~10MG~A~070943~001~~Aug 3, 19
87~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
OXAZEPAM~CAPSULE;ORAL~OXAZEPAM~MUTUAL PHARM~10MG~A~071026~002~~Aug 10, 1987~No~D
ISCN~MUTUAL PHARMACEUTICAL CO INC
OXAZEPAM~CAPSULE;ORAL~OXAZEPAM~MYLAN~10MG~A~071713~001~~Oct 20, 1987~No~DISCN~MY

OXAZEPAM~CAPSULE;ORAL~OXAZEPAM~SANDOZ~10MG~A~071813~001~AB~Apr 19, 1988~No~RX~SA
NDOZ INC
NDOZ INC
NDOZ INC
OXAZEPAM~CAPSULE;ORAL~OXAZEPAM~WATSON LABS~10MG~A~072952~001~~Sep 28, 1990~No~DI
SCN~WATSON LABORATORIES INC
METHOXSALEN~CAPSULE;ORAL~OXSORALEN-ULTRA~DOW PHARM~10MG~N~019600~001~AB~Oct 30,
1986~Yes~RX~DOW PHARMACEUTICAL SCIENCES
OXYTETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~OXY-KESSO-TETRA~FERRANTE~EQ 250MG BAS
E~A~060179~001~~Approved Prior to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~CAPSULE;ORAL~OXYCODONE AND ACETAMINOPHEN~
ACTAVIS ELIZABETH~500MG;5MG~A~040199~001~~Dec 30, 1998~No~DISCN~ACTAVIS ELIZABET
H LLC
BARR~500MG;5MG~A~040304~001~~Oct 2, 2000~No~DISCN~BARR LABORATORIES INC
DURAMED PHARMS BARR~500MG;5MG~A~040289~001~~Mar 16, 1999~No~DISCN~DURAMED PHARMA
CEUTICALS INC SUB BARR LABORATORIES INC
HALSEY~500MG;5MG~A~089994~001~~May 4, 1989~No~DISCN~HALSEY DRUG CO INC
MALLINCKRODT~500MG;5MG~A~040257~001~~Aug 4, 1998~No~DISCN~MALLINCKRODT CHEMICAL
INC
MUTUAL PHARM~500MG;5MG~A~040219~001~~Jan 22, 1998~No~DISCN~MUTUAL PHARMACEUTICAL
CO INC
VINTAGE PHARMS~500MG;5MG~A~040106~001~~Jul 30, 1996~No~DISCN~VINTAGE PHARMACEUTI
CALS INC
VINTAGE PHARMS LLC~500MG;5MG~A~040303~001~~Dec 30, 1999~No~DISCN~VINTAGE PHARMAC
EUTICALS LLC
WATSON LABS~500MG;5MG~A~040234~001~~Oct 30, 1997~No~DISCN~WATSON LABORATORIES IN
C
OXYCODONE HYDROCHLORIDE~CAPSULE;ORAL~OXYCODONE HYDROCHLORIDE~COASTAL PHARMS~5MG~
A~203107~001~AB~Jul 26, 2012~No~RX~COASTAL PHARMACEUTICALS
OXYCODONE HYDROCHLORIDE~CAPSULE;ORAL~OXYCODONE HYDROCHLORIDE~LANNETT HOLDINGS IN
C~5MG~A~203823~001~AB~Aug 1, 2014~No~RX~LANNETT HOLDINGS INC
OXYCODONE HYDROCHLORIDE~CAPSULE;ORAL~OXYCODONE HYDROCHLORIDE~LEHIGH VALLEY~5MG~N
~200534~001~AB~Oct 20, 2010~Yes~RX~LEHIGH VALLEY TECHNOLOGIES INC
OXYTETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~OXYTETRACYCLINE HYDROCHLORIDE~HIKMA P
HARMS LLC~EQ 250MG BASE~A~060770~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIK
MA PHARMACEUTICALS LLC
OXYTETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~OXYTETRACYCLINE HYDROCHLORIDE~IMPAX L
ABS~EQ 250MG BASE~A~060760~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LAB
ORATORIES INC
OXYTETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~OXYTETRACYCLINE HYDROCHLORIDE~PROTER~
EQ 250MG BASE~A~060869~001~~Approved Prior to Jan 1, 1982~No~DISCN~PROTER LABORA

TORY SPA
OXYTETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~OXYTETRACYCLINE HYDROCHLORIDE~PUREPAC
PHARM~EQ 250MG BASE~A~060634~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPA
C PHARMACEUTICAL CO
NORTRIPTYLINE HYDROCHLORIDE~CAPSULE;ORAL~PAMELOR~MALLINCKRODT LLC~EQ 10MG BASE~N
~018013~001~AB~Approved Prior to Jan 1, 1982~No~RX~MALLINCKRODT LLC
~018013~003~AB~Approved Prior to Jan 1, 1982~Yes~RX~MALLINCKRODT LLC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~PANMYCIN~PHARMACIA AND UPJOHN~250MG~A~06
0347~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
PARAMETHADIONE~CAPSULE;ORAL~PARADIONE~ABBVIE~150MG~N~006800~003~~Approved Prior
to Jan 1, 1982~No~DISCN~ABBVIE INC
PARAMETHADIONE~CAPSULE;ORAL~PARADIONE~ABBVIE~300MG~N~006800~001~~Approved Prior
PARICALCITOL~CAPSULE;ORAL~PARICALCITOL~BANNER LIFE SCIENCES~1MCG~A~202539~001~AB
~Mar 27, 2014~No~RX~BANNER LIFE SCIENCES LLC
PARICALCITOL~CAPSULE;ORAL~PARICALCITOL~DR REDDYS LABS LTD~1MCG~A~091412~001~AB~J
un 24, 2014~No~RX~DR REDDYS LABORATORIES LTD
PARICALCITOL~CAPSULE;ORAL~PARICALCITOL~RISING PHARMS INC~1MCG~A~202124~001~AB~Ju
n 24, 2014~No~RX~RISING PHARMACEUTICALS INC
PARICALCITOL~CAPSULE;ORAL~PARICALCITOL~TEVA PHARMS USA~1MCG~A~090829~001~AB~Sep
BROMOCRIPTINE MESYLATE~CAPSULE;ORAL~PARLODEL~US PHARMS HOLDINGS I~EQ 5MG BASE~N~
017962~002~AB~Mar 1, 1982~Yes~RX~US PHARMACEUTICALS HOLDINGS I LLC
PAROMOMYCIN SULFATE~CAPSULE;ORAL~PAROMOMYCIN SULFATE~HERITAGE PHARMS INC~EQ 250M
G BASE~A~065173~001~AA~Dec 14, 2007~No~RX~HERITAGE PHARMACEUTICALS INC
PAROMOMYCIN SULFATE~CAPSULE;ORAL~PAROMOMYCIN SULFATE~SUN PHARM INDS INC~EQ 250MG
BASE~A~064171~001~AA~Jun 30, 1997~Yes~RX~SUN PHARMACEUTICAL INDUSTRIES INC
POTASSIUM AMINOSALICYLATE~CAPSULE;ORAL~PASKALIUM~GLENWOOD~500MG~N~009395~004~~Ap
proved Prior to Jan 1, 1982~No~DISCN~GLENWOOD INC
DICLOXACILLIN SODIUM~CAPSULE;ORAL~PATHOCIL~WYETH AYERST~EQ 250MG BASE~N~050011~0
02~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
DICLOXACILLIN SODIUM~CAPSULE;ORAL~PATHOCIL~WYETH AYERST~EQ 500MG BASE~N~050011~0
03~~Mar 28, 1983~No~DISCN~WYETH AYERST LABORATORIES
PAROXETINE HYDROCHLORIDE~CAPSULE;ORAL~PAXIL~APOTEX TECHNOLOGIES~EQ 10MG BASE **F
safety or efficacy reasons**~N~020885~001~~Oct 9, 1998~No~DISCN~APOTEX TECHNOLO
GIES INC
GIES INC
GIES INC
GIES INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PENBRITIN~WYETH AYERST~EQ 250MG BA
SE~A~060908~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIE
S
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PENBRITIN~WYETH AYERST~EQ 500MG BA
SE~A~060908~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIE
S
PENTOBARBITAL SODIUM~CAPSULE;ORAL~PENTOBARBITAL SODIUM~LANNETT~50MG~A~085937~001
~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~PENTOBARBITAL SODIUM~LANNETT~100MG~A~085915~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~PENTOBARBITAL SODIUM~VITARINE~100MG~A~083284~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~PENTOBARBITAL SODIUM~WHITEWORTH TOWN PLSN~100M
G~A~083338~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN
INC
POTASSIUM PERCHLORATE~CAPSULE;ORAL~PERCHLORACAP~MALLINCKRODT~200MG~N~017551~001~
~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~PERIOSTAT~COLLAGENEX~EQ 20MG BASE~N~050744~001~
~Sep 30, 1998~No~DISCN~COLLAGENEX INC
DESIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~PERTOFRANE~SANOFI AVENTIS US~25MG~N~01362
1~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
DESIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~PERTOFRANE~SANOFI AVENTIS US~50MG~N~01362
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PFIZERPEN-A~PFIZER~EQ 250MG BASE~A
~062050~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZ
ER INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PFIZERPEN-A~PFIZER~EQ 500MG BASE~A
ER INC
ACETAMINOPHEN; CODEINE PHOSPHATE~CAPSULE;ORAL~PHENAPHEN W/ CODEINE NO. 2~ROBINS
AH~325MG;15MG~A~084444~001~~Approved Prior to Jan 1, 1982~No~DISCN~AH ROBINS CO
PHENDIMETRAZINE TARTRATE~CAPSULE;ORAL~PHENAZINE~MAST MM~35MG~A~086523~001~~Appro
PHENDIMETRAZINE TARTRATE~CAPSULE;ORAL~PHENDIMETRAZINE TARTRATE~SANDOZ~35MG~A~085
633~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
PHENDIMETRAZINE TARTRATE~CAPSULE;ORAL~PHENDIMETRAZINE TARTRATE~VITARINE~35MG~A~0

85634~001~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
PHENOXYBENZAMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENOXYBENZAMINE HYDROCHLORIDE~ROXAN
E~10MG~A~201050~001~AB~Jul 16, 2012~No~RX~ROXANE LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~ABC HOLDING~30M
G~A~085411~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABC HOLDING CORP
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~ABLE~15MG~A~040
497~001~~Mar 13, 2003~No~DISCN~ABLE LABORATORIES INC
403~001~~Aug 30, 2001~No~DISCN~ABLE LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~BARR~15MG~A~090
591~001~AA~Mar 18, 2010~No~RX~BARR LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~BARR~30MG~A~090
591~002~AA~Mar 18, 2010~No~RX~BARR LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~CAMALL~15MG~A~0
86735~001~~Approved Prior to Jan 1, 1982~No~DISCN~CAMALL CO INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~CAMALL~30MG~A~0
87226~001~~Approved Prior to Jan 1, 1982~No~DISCN~CAMALL CO INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~DURAMED PHARMS
BARR~30MG~A~088948~001~~Apr 25, 1986~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BA
RR LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~ELITE LABS~15MG
~A~202248~001~AA~Sep 28, 2012~No~RX~ELITE LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~ELITE LABS~30MG
~A~202248~002~AA~Sep 28, 2012~No~RX~ELITE LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~INVAGEN PHARMS~
15MG~A~202858~001~AA~Feb 14, 2014~No~RX~INVAGEN PHARMACEUTICALS INC
30MG~A~202858~002~AA~Feb 14, 2014~No~RX~INVAGEN PHARMACEUTICALS INC
30MG~A~204414~001~AA~May 5, 2014~No~RX~INVAGEN PHARMACEUTICALS INC
37.5MG~A~202846~001~AA~Feb 5, 2014~No~RX~INVAGEN PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~IVAX PHARMS~30M
G~A~086329~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~KEN LIFESCIENCE
~15MG~A~205019~001~AA~Dec 5, 2014~No~RX~KEN LIFESCIENCE
~30MG~A~205019~002~AA~Dec 5, 2014~No~RX~KEN LIFESCIENCE
~37.5MG~A~205017~001~AA~Sep 25, 2014~No~RX~KEN LIFESCIENCE
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~KVK TECH~15MG~A
~040886~002~AA~Mar 31, 2008~No~RX~KVK TECH INC

PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~KVK TECH~37.5MG
~A~040887~001~AA~Apr 24, 2008~No~RX~KVK TECH INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~LANNETT~15MG~A~
087022~002~AA~Jan 20, 2012~No~RX~LANNETT CO INC
087022~001~AA~Feb 3, 1983~No~RX~LANNETT CO INC
091359~001~AA~Jul 16, 2010~No~RX~LANNETT HOLDINGS INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~LANNETT HOLDING
S INC~37.5MG~A~201961~001~AA~Jul 20, 2011~No~RX~LANNETT HOLDINGS INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~MIKAH PHARMA~15
MG~A~040460~001~~Jan 14, 2003~No~DISCN~MIKAH PHARMA LLC
MG~A~040227~001~~Jun 18, 1997~No~DISCN~MIKAH PHARMA LLC
MG~A~040448~001~~Jan 22, 2003~No~DISCN~MIKAH PHARMA LLC
.5MG~A~040228~001~~Jun 19, 1997~No~DISCN~MIKAH PHARMA LLC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~MUTUAL PHARM~30
MG~A~040525~001~AA~Oct 23, 2003~No~RX~MUTUAL PHARMACEUTICAL CO INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~MUTUAL PHARM~37
.5MG~A~040527~001~~Oct 23, 2003~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~SANDOZ~15MG~A~0
87190~002~AA~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
86945~001~AA~Jul 20, 1983~Yes~RX~SANDOZ INC
87190~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~SANDOZ~37.5MG~A
~088414~001~~Oct 19, 1983~No~DISCN~SANDOZ INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~TEVA~30MG~A~086
911~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
777~001~~Nov 1, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~TG UNITED INC~3
0MG~A~040083~001~~Mar 7, 1997~No~DISCN~TG UNITED INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~TG UNITED LABS~
18.75MG~A~088576~001~~May 23, 1984~No~DISCN~TG UNITED LABS LLC
30MG~A~085417~001~~Approved Prior to Jan 1, 1982~No~DISCN~TG UNITED LABS LLC
37.5MG~A~087915~001~~Dec 22, 1983~No~DISCN~TG UNITED LABS LLC

37.5MG~A~087930~001~~Oct 14, 1983~No~DISCN~TG UNITED LABS LLC
37.5MG~A~088610~001~~Jun 4, 1984~No~DISCN~TG UNITED LABS LLC
37.5MG~A~088611~001~~Jun 4, 1984~No~DISCN~TG UNITED LABS LLC
37.5MG~A~088625~001~~Aug 23, 1984~No~DISCN~TG UNITED LABS LLC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~USL PHARMA~30MG
~A~084487~001~~Apr 9, 1982~No~DISCN~USL PHARMA INC
~A~088430~001~~Mar 27, 1984~No~DISCN~USL PHARMA INC
~A~088797~001~~Dec 10, 1984~No~DISCN~USL PHARMA INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~VITARINE~30MG~A
~087202~001~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~VITARINE~30MG~A
~087235~001~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~CAPSULE;ORAL~PHENTERMINE HYDROCHLORIDE~WATSON LABS~30M
G~A~086740~001~~Mar 21, 1985~No~DISCN~WATSON LABORATORIES INC
PHENYLBUTAZONE~CAPSULE;ORAL~PHENYLBUTAZONE~IVAX PHARMS~100MG~A~088218~001~~Jun 2
4, 1983~No~DISCN~IVAX PHARMACEUTICALS INC
PHENYLBUTAZONE~CAPSULE;ORAL~PHENYLBUTAZONE~MUTUAL PHARM~100MG~A~088994~001~~Dec
4, 1985~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
PHENYLBUTAZONE~CAPSULE;ORAL~PHENYLBUTAZONE~SANDOZ~100MG~A~087774~001~~Jun 16, 19
82~No~DISCN~SANDOZ INC
PHENYLBUTAZONE~CAPSULE;ORAL~PHENYLBUTAZONE~WATSON LABS~100MG~A~087756~001~~Dec 1
PHENYTOIN SODIUM~CAPSULE;ORAL~PHENYTEK~MYLAN~200MG EXTENDED~A~040298~002~AB~Dec
PHENYTOIN SODIUM~CAPSULE;ORAL~PHENYTEK~MYLAN~300MG EXTENDED~A~040298~003~AB~Dec
6, 2001~Yes~RX~MYLAN PHARMACEUTICALS INC
PHENYTOIN SODIUM~CAPSULE;ORAL~PHENYTEX~WATSON LABS~100MG EXTENDED~A~088711~001~~
Dec 21, 1984~No~DISCN~WATSON LABORATORIES INC
PHENYTOIN SODIUM~CAPSULE;ORAL~PHENYTOIN SODIUM~PHARMERAL~100MG PROMPT~A~085435~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMERAL INC
PHENYTOIN SODIUM~CAPSULE;ORAL~PHENYTOIN SODIUM~WATSON LABS~100MG PROMPT~A~085894
~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
CALCIUM ACETATE~CAPSULE;ORAL~PHOSLO~FRESENIUS MEDCL~EQ 84.5MG CALCIUM~N~021160~0
01~~Apr 2, 2001~No~DISCN~FRESENIUS MEDICAL CARE NORTH AMERICA
CALCIUM ACETATE~CAPSULE;ORAL~PHOSLO~FRESENIUS MEDCL~EQ 169MG CALCIUM~N~021160~00
2~~Apr 2, 2001~No~DISCN~FRESENIUS MEDICAL CARE NORTH AMERICA
CALCIUM ACETATE~CAPSULE;ORAL~PHOSLO GELCAPS~FRESENIUS MEDCL~EQ 169MG CALCIUM~N~0
21160~003~AB~Apr 2, 2001~Yes~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
ACETAMINOPHEN; BUTALBITAL~CAPSULE;ORAL~PHRENILIN FORTE~VALEANT~650MG;50MG~A~0888
31~001~~Jun 19, 1985~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE~CAPSULE;ORAL~PHRENILIN WI
TH CAFFEINE AND CODEINE~VALEANT~325MG;50MG;40MG;30MG~A~074911~001~~Aug 22, 2001~
No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
PIROXICAM~CAPSULE;ORAL~PIROXICAM~CYCLE PHARMS LTD~10MG~A~073651~001~~Feb 26, 199
3~No~DISCN~CYCLE PHARMACEUTICALS LTD
PIROXICAM~CAPSULE;ORAL~PIROXICAM~CYCLE PHARMS LTD~20MG~A~073651~002~~Feb 26, 199
PIROXICAM~CAPSULE;ORAL~PIROXICAM~EGIS~10MG~A~074808~001~~Jul 8, 1997~No~DISCN~EG
IS PHARMACEUTICALS
PIROXICAM~CAPSULE;ORAL~PIROXICAM~EGIS~20MG~A~074808~002~~Jul 8, 1997~No~DISCN~EG
IS PHARMACEUTICALS
PIROXICAM~CAPSULE;ORAL~PIROXICAM~IVAX SUB TEVA PHARMS~10MG~A~074148~001~~Jun 3,
PIROXICAM~CAPSULE;ORAL~PIROXICAM~IVAX SUB TEVA PHARMS~20MG~A~074148~002~~Jun 3,

PIROXICAM~CAPSULE;ORAL~PIROXICAM~MUTUAL PHARM~10MG~A~073535~001~AB~Mar 12, 1993~
No~RX~MUTUAL PHARMACEUTICAL CO INC
PIROXICAM~CAPSULE;ORAL~PIROXICAM~MUTUAL PHARM~20MG~A~073536~001~~Mar 12, 1993~No
~DISCN~MUTUAL PHARMACEUTICAL CO INC
PIROXICAM~CAPSULE;ORAL~PIROXICAM~MYLAN~10MG~A~074043~001~~Sep 22, 1992~No~DISCN~
PIROXICAM~CAPSULE;ORAL~PIROXICAM~MYLAN~10MG~A~074102~001~AB~Jul 31, 1992~No~RX~M
PIROXICAM~CAPSULE;ORAL~PIROXICAM~MYLAN~20MG~A~074043~002~~Sep 22, 1992~No~DISCN~
PIROXICAM~CAPSULE;ORAL~PIROXICAM~MYLAN~20MG~A~074102~002~AB~Jul 31, 1992~No~RX~M
PIROXICAM~CAPSULE;ORAL~PIROXICAM~NOSTRUM LABS~10MG~A~074116~001~AB~Jun 15, 1993~
No~RX~NOSTRUM LABORATORIES INC
PIROXICAM~CAPSULE;ORAL~PIROXICAM~NOSTRUM LABS~20MG~A~074118~001~AB~Jun 15, 1993~
No~RX~NOSTRUM LABORATORIES INC
PIROXICAM~CAPSULE;ORAL~PIROXICAM~SCS~10MG~A~074036~001~~May 29, 1992~No~DISCN~SC
S PHARMACEUTICALS
PIROXICAM~CAPSULE;ORAL~PIROXICAM~SCS~20MG~A~074036~002~~May 29, 1992~No~DISCN~SC
S PHARMACEUTICALS
PIROXICAM~CAPSULE;ORAL~PIROXICAM~TEVA~10MG~A~073637~001~~Jan 28, 1994~No~DISCN~T
PIROXICAM~CAPSULE;ORAL~PIROXICAM~TEVA~10MG~A~074131~001~AB~Dec 11, 1992~No~RX~TE
PIROXICAM~CAPSULE;ORAL~PIROXICAM~TEVA~20MG~A~073638~001~~Jan 28, 1994~No~DISCN~T
PIROXICAM~CAPSULE;ORAL~PIROXICAM~TEVA~20MG~A~074131~002~AB~Dec 11, 1992~No~RX~TE
PIROXICAM~CAPSULE;ORAL~PIROXICAM~TEVA PHARMS~10MG~A~074103~001~~Aug 28, 1992~No~
DISCN~TEVA PHARMACEUTICALS USA
PIROXICAM~CAPSULE;ORAL~PIROXICAM~TEVA PHARMS~20MG~A~074103~002~~Aug 28, 1992~No~
PIROXICAM~CAPSULE;ORAL~PIROXICAM~WATSON LABS~10MG~A~074287~001~~May 16, 1996~No~
DISCN~WATSON LABORATORIES INC
PIROXICAM~CAPSULE;ORAL~PIROXICAM~WATSON LABS~10MG~A~074460~001~~Sep 29, 1995~No~
PIROXICAM~CAPSULE;ORAL~PIROXICAM~WATSON LABS~20MG~A~074287~002~~May 16, 1996~No~
PIROXICAM~CAPSULE;ORAL~PIROXICAM~WATSON LABS~20MG~A~074460~002~~Sep 29, 1995~No~
ETHCHLORVYNOL~CAPSULE;ORAL~PLACIDYL~ABBVIE~100MG~N~010021~004~~Approved Prior to
Jan 1, 1982~No~DISCN~ABBVIE INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~POLYCILLIN~BRISTOL~EQ 250MG BASE~N
~050310~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV
BRISTOL MYERS CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~POLYCILLIN~BRISTOL~EQ 500MG BASE~N
BRISTOL MYERS CO
POMALIDOMIDE~CAPSULE;ORAL~POMALYST~CELGENE~1MG~N~204026~001~~Feb 8, 2013~No~RX~C
ELGENE CORP
ELGENE CORP
ELGENE CORP
POMALIDOMIDE~CAPSULE;ORAL~POMALYST~CELGENE~4MG~N~204026~004~~Feb 8, 2013~Yes~RX~
CELGENE CORP
MEFENAMIC ACID~CAPSULE;ORAL~PONSTEL~SHIONOGI INC~250MG~N~015034~003~AB~Approved
Prior to Jan 1, 1982~Yes~RX~SHIONOGI INC
DABIGATRAN ETEXILATE MESYLATE~CAPSULE;ORAL~PRADAXA~BOEHRINGER INGELHEIM~EQ 75MG
BASE~N~022512~001~~Oct 19, 2010~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
DABIGATRAN ETEXILATE MESYLATE~CAPSULE;ORAL~PRADAXA~BOEHRINGER INGELHEIM~EQ 150MG
BASE~N~022512~002~~Oct 19, 2010~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
PRAZEPAM~CAPSULE;ORAL~PRAZEPAM~USL PHARMA~5MG~A~070427~001~~Nov 6, 1987~No~DISCN
~USL PHARMA INC
PRAZEPAM~CAPSULE;ORAL~PRAZEPAM~USL PHARMA~10MG~A~070428~001~~Nov 6, 1987~No~DISC
N~USL PHARMA INC
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~AM THERAP~EQ 1MG BASE
~A~072782~001~~May 16, 1989~No~DISCN~AMERICAN THERAPEUTICS INC
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~DAVA PHARMS INC~EQ 1M
G BASE~A~072705~001~~May 16, 1989~No~DISCN~DAVA PHARMACEUTICALS INC
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~IVAX SUB TEVA PHARMS~
EQ 1MG BASE~A~071994~001~AB~Sep 12, 1988~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA
PHARMACEUTICALS USA
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~MYLAN~EQ 1MG BASE~A~0
72575~003~AB~May 16, 1989~No~RX~MYLAN PHARMACEUTICALS INC
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~PUREPAC PHARM~EQ 1MG
BASE~A~072991~001~~May 16, 1989~No~DISCN~PUREPAC PHARMACEUTICAL CO
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~SANDOZ~EQ 1MG BASE~A~
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~TEVA PHARMS~EQ 2MG BA
SE~A~071995~001~AB~Sep 12, 1988~No~RX~TEVA PHARMACEUTICALS USA
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~TEVA PHARMS~EQ 5MG BA
SE~A~071745~001~AB~Sep 12, 1988~No~RX~TEVA PHARMACEUTICALS USA
PRAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~PRAZOSIN HYDROCHLORIDE~WATSON LABS~EQ 1MG BA
PREGABALIN~CAPSULE;ORAL~PREGABALIN~LUPIN LTD~25MG~A~091040~001~AB~Jul 3, 2012~No
~RX~LUPIN LTD
~RX~LUPIN LTD
~RX~LUPIN LTD
PREGABALIN~CAPSULE;ORAL~PREGABALIN~LUPIN LTD~100MG~A~091040~004~AB~Jul 3, 2012~N
o~RX~LUPIN LTD
o~RX~LUPIN LTD
o~RX~LUPIN LTD
o~RX~LUPIN LTD
o~RX~LUPIN LTD
PREGABALIN~CAPSULE;ORAL~PREGABALIN~TEVA PHARMS~25MG~A~091219~001~AB~Jul 3, 2012~
No~RX~TEVA PHARMACEUTICALS USA
PREGABALIN~CAPSULE;ORAL~PREGABALIN~TEVA PHARMS~100MG~A~091224~002~AB~Jul 3, 2012
PREGABALIN~CAPSULE;ORAL~PREGABALIN~WATSON LABS INC~25MG~A~091221~001~AB~Jul 3, 2
PREGABALIN~CAPSULE;ORAL~PREGABALIN~WATSON LABS INC~100MG~A~091221~004~AB~Jul 3,
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PRINCIPEN~APOTHECON~EQ 250MG BASE~
A~062888~001~~Mar 4, 1988~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PRINCIPEN~APOTHECON~EQ 500MG BASE~
A~062888~002~~Mar 4, 1988~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PRINCIPEN~BRISTOL MYERS SQUIBB~EQ
250MG BASE~A~061392~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQ
UIBB CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PRINCIPEN~BRISTOL MYERS SQUIBB~EQ
500MG BASE~A~061392~002~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQ
UIBB CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~PRINCIPEN '250'~APOTHECON~EQ 250MG
BASE~A~062157~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL
MYERS SQUIBB CO
BASE~N~050056~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL
MYERS SQUIBB CO
BASE~A~062157~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL
MYERS SQUIBB CO
BASE~N~050056~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL
MYERS SQUIBB CO
AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID~CAPSULE;ORAL~PRINCIPEN W/ PROBENECI
D~APOTHECON~EQ 389MG BASE;111MG~A~062150~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~APOTHECON SUB BRISTOL MYERS SQUIBB CO
AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID~CAPSULE;ORAL~PRINCIPEN W/ PROBENECI
D~APOTHECON~EQ 389MG BASE;111MG~N~050488~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~APOTHECON SUB BRISTOL MYERS SQUIBB CO
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~ASCOT~250MG~A
~087542~001~~Jan 8, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LA
BORATORIES INC
~087697~001~~Mar 1, 1983~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LA
BORATORIES INC
~087543~001~~Jan 8, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LA
BORATORIES INC
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~IVAX SUB TEVA
PHARMS~250MG~A~084604~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACE
UTICALS INC SUB TEVA PHARMACEUTICALS USA
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~LANNETT~250MG
~A~083693~001~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~LANNETT~500MG
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~LEDERLE~250MG
~A~086942~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV A
MERICAN CYANAMID CO
MERICAN CYANAMID CO
MERICAN CYANAMID CO
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~ROXANE~250MG~
A~088989~001~~Apr 26, 1985~No~DISCN~ROXANE LABORATORIES INC
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~ROXANE~500MG~
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~SANDOZ~250MG~
A~089219~001~~Jul 1, 1986~No~DISCN~SANDOZ INC
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~VANGARD~250MG
~A~087643~001~~Jun 1, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL
CO
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~VANGARD~500MG
~A~087875~001~~Jun 1, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL
CO
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAINAMIDE HYDROCHLORIDE~WATSON LABS~2

50MG~A~083287~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES IN
C
C
C
C
C
C
C
C
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAN~PARKE DAVIS~250MG~A~085804~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PROCAPAN~PANRAY~250MG~A~083553~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO I
NC
NIFEDIPINE~CAPSULE;ORAL~PROCARDIA~PFIZER~10MG~N~018482~001~AB~Approved Prior to
Jan 1, 1982~Yes~RX~PFIZER INC
NIFEDIPINE~CAPSULE;ORAL~PROCARDIA~PFIZER~20MG~N~018482~002~~Jul 24, 1986~No~DISC
N~PFIZER INC
PROGESTERONE~CAPSULE;ORAL~PROGESTERONE~BANNER LIFE SCIENCES~100MG~A~200900~001~A
B~Aug 16, 2013~No~RX~BANNER LIFE SCIENCES LLC
PROGESTERONE~CAPSULE;ORAL~PROGESTERONE~BANNER LIFE SCIENCES~200MG~A~200900~002~A
B~Aug 16, 2013~No~RX~BANNER LIFE SCIENCES LLC
PROGESTERONE~CAPSULE;ORAL~PROGESTERONE~SOFGEN PHARMS~100MG~A~200456~001~AB~Sep 2
8, 2012~No~RX~SOFGEN PHARMACEUTICALS LLC
PROGESTERONE~CAPSULE;ORAL~PROGESTERONE~SOFGEN PHARMS~200MG~A~200456~002~AB~Sep 2
8, 2012~No~RX~SOFGEN PHARMACEUTICALS LLC
PROGESTERONE~CAPSULE;ORAL~PROGESTERONE~TEVA PHARMS~100MG~A~202121~001~AB~Feb 29,
PROGESTERONE~CAPSULE;ORAL~PROGESTERONE~TEVA PHARMS~200MG~A~202121~002~AB~Feb 29,
DIAZOXIDE~CAPSULE;ORAL~PROGLYCEM~TEVA BRANDED PHARM~50MG~N~017425~001~~Approved
Prior to Jan 1, 1982~No~DISCN~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
DIAZOXIDE~CAPSULE;ORAL~PROGLYCEM~TEVA BRANDED PHARM~100MG~N~017425~002~~Approved
Prior to Jan 1, 1982~No~DISCN~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
TACROLIMUS~CAPSULE;ORAL~PROGRAF~ASTELLAS~EQ 0.5MG BASE~N~050708~003~AB~Aug 24, 1
998~No~RX~ASTELLAS PHARMA US INC
TACROLIMUS~CAPSULE;ORAL~PROGRAF~ASTELLAS~EQ 1MG BASE~N~050708~001~AB~Apr 8, 1994
~No~RX~ASTELLAS PHARMA US INC
TACROLIMUS~CAPSULE;ORAL~PROGRAF~ASTELLAS~EQ 5MG BASE~N~050708~002~AB~Apr 8, 1994
~Yes~RX~ASTELLAS PHARMA US INC
PROGESTERONE~CAPSULE;ORAL~PROMETRIUM~ABBVIE INC~100MG~N~019781~001~AB~May 14, 19
98~No~RX~ABBVIE INC
PROGESTERONE~CAPSULE;ORAL~PROMETRIUM~ABBVIE INC~200MG~N~019781~002~AB~Oct 15, 19
99~Yes~RX~ABBVIE INC
PROGESTERONE~CAPSULE;ORAL~PROMETRIUM~ABBVIE INC~300MG~N~019781~003~~Oct 15, 1999
~No~DISCN~ABBVIE INC
PHENYTOIN SODIUM~CAPSULE;ORAL~PROMPT PHENYTOIN SODIUM~ANI PHARMS INC~100MG PROMP
T~A~080259~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANI PHARMACEUTICALS INC
PHENYTOIN SODIUM~CAPSULE;ORAL~PROMPT PHENYTOIN SODIUM~WATSON LABS~100MG PROMPT~A
PROCAINAMIDE HYDROCHLORIDE~CAPSULE;ORAL~PRONESTYL~APOTHECON~250MG~N~007335~001~~
Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPHENE 65~HALSEY~65MG~A~083538~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE COMPOUND
65~IVAX SUB TEVA PHARMS~389MG;32.4MG;65MG~A~083077~002~~Dec 7, 1984~No~DISCN~IV
AX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
65~SANDOZ~389MG;32.4MG;65MG~A~080044~002~~Sep 16, 1983~No~DISCN~SANDOZ INC
65~TEVA~389MG;32.4MG;65MG~A~089025~001~~Mar 29, 1985~No~DISCN~TEVA PHARMACEUTIC
ALS USA INC
-65~SANDOZ~389MG;32.4MG;65MG~A~083101~002~~Jun 24, 1985~No~DISCN~SANDOZ INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~ALRA~65MG~A~0
83184~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~IMPAX LABS~65
MG~A~083317~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~IVAX SUB TEVA
PHARMS~32MG~A~083597~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEU
TICALS INC SUB TEVA PHARMACEUTICALS USA
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~MUTUAL PHARM~
65MG~A~083186~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL
CO INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~MYLAN~32MG~A~
083528~001~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
040569~001~~Dec 16, 2004~No~DISCN~MYLAN PHARMACEUTICALS INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~NEXGEN PHARMA
INC~65MG~A~083185~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~PAR PHARM~65M
G~A~080269~001~~Approved Prior to Jan 1, 1982~No~DISCN~PAR PHARMACEUTICAL INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~PUREPAC PHARM
~65MG~A~083278~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICA
L CO
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~PVT FORM~32MG
~A~083464~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~PVT FORM~65MG
~A~083113~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~ROXANE~32MG~A
~083089~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~ROXANE~65MG~A
~083089~002~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~SANDOZ~32MG~A
~084014~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC

PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~TEVA~65MG~A~0
88615~001~~Oct 22, 1984~No~DISCN~TEVA PHARMACEUTICALS USA INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~VALEANT PHARM
INTL~65MG~A~080783~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACE
UTICALS INTERNATIONAL
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~VINTAGE PHARM
S~65MG~A~040908~001~~Jul 17, 2009~No~DISCN~VINTAGE PHARMACEUTICALS INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~WATSON LABS~6
5MG~A~080908~002~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~WATSON LABS~6
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~WEST WARD~65M
G~A~083501~001~~Approved Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL
CORP
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE~WHITEWORTH TO
WN PLSN~65MG~A~084551~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOW
NE PAULSEN INC
PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHLORIDE 65~WARNER CHI
LCOTT~65MG~A~083786~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT
DIV WARNER LAMBERT CO
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE~CAPSULE;ORAL~PROPOXYPHENE HYDROCHL
ORIDE W/ ASPIRIN AND CAFFEINE~WATSON LABS~389MG;32.4MG;65MG~A~085732~002~~Sep 3,
OXACILLIN SODIUM~CAPSULE;ORAL~PROSTAPHLIN~APOTHECON~EQ 500MG BASE~N~050118~002~~
ACETAMINOPHEN; CODEINE PHOSPHATE~CAPSULE;ORAL~PROVAL #3~SOLVAY~325MG;30MG~A~0856
85~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~PROZAC~ELI LILLY AND CO~EQ 10MG BASE~N~018
936~006~AB1~Dec 23, 1992~No~RX~ELI LILLY AND CO
936~001~AB1~Dec 29, 1987~No~RX~ELI LILLY AND CO
936~003~AB~Jun 15, 1999~Yes~RX~ELI LILLY AND CO
936~004~~Jun 15, 1999~No~DISCN~ELI LILLY AND CO
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE~CAPSULE;ORAL~PYLERA~FO
REST LABS INC~140MG;125MG;125MG~N~050786~001~~Sep 28, 2006~Yes~RX~FOREST LABORAT
ORIES INC
UREA, C-14~CAPSULE;ORAL~PYTEST~AVENT~1uCi~N~020617~001~~May 9, 1997~Yes~RX~AVENT
INC
UREA, C-14~CAPSULE;ORAL~PYTEST KIT~AVENT~1uCi~N~020617~002~~May 9, 1997~Yes~RX~A
VENT INC
QUININE SULFATE~CAPSULE;ORAL~QUALAQUIN~MUTUAL PHARM CO INC~324MG~N~021799~001~AB
~Aug 12, 2005~Yes~RX~MUTUAL PHARMACEUTICAL CO INC
CLIDINIUM BROMIDE~CAPSULE;ORAL~QUARZAN~ROCHE~2.5MG~N~010355~001~~Approved Prior
to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
CLIDINIUM BROMIDE~CAPSULE;ORAL~QUARZAN~ROCHE~5MG~N~010355~002~~Approved Prior to
Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
QUINIDINE SULFATE~CAPSULE;ORAL~QUINIDINE SULFATE~LILLY~200MG~A~085103~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
QUININE SULFATE~CAPSULE;ORAL~QUININE SULFATE~MYLAN PHARMS INC~324MG~A~202581~001
~AB~Dec 14, 2012~No~RX~MYLAN PHARMACEUTICALS INC
QUININE SULFATE~CAPSULE;ORAL~QUININE SULFATE~TEVA PHARMS~324MG~A~091661~001~AB~S

ep 28, 2012~No~RX~TEVA PHARMACEUTICALS USA
FERRIC HEXACYANOFERRATE(II)~CAPSULE;ORAL~RADIOGARDASE (PRUSSIAN BLUE)~HEYL CHEMI
SCH~500MG~N~021626~001~~Oct 2, 2003~Yes~RX~HEYL CHEMISCH PHARMAZEUTISHE FABRIK
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ACCORD HLTHCARE INC~1.25MG~A~202392~001~AB~Apr 15
, 2014~No~RX~ACCORD HEALTHCARE INC USA
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ACCORD HLTHCARE INC~2.5MG~A~202392~002~AB~Apr 15,
2014~No~RX~ACCORD HEALTHCARE INC USA
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ACCORD HLTHCARE INC~5MG~A~202392~003~AB~Apr 15, 2
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ACCORD HLTHCARE INC~10MG~A~202392~004~AB~Apr 15,
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ACTAVIS ELIZABETH~1.25MG~A~077513~001~~Jun 18, 20
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ACTAVIS ELIZABETH~2.5MG~A~077513~002~~Jun 18, 200
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ACTAVIS ELIZABETH~5MG~A~077513~003~~Jun 18, 2008~
No~DISCN~ACTAVIS ELIZABETH LLC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ACTAVIS ELIZABETH~10MG~A~077513~004~~Jun 18, 2008
~No~DISCN~ACTAVIS ELIZABETH LLC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~APOTEX~1.25MG~A~079116~001~AB~Jun 20, 2008~No~RX~
APOTEX INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~APOTEX~2.5MG~A~079116~002~AB~Jun 20, 2008~No~RX~A
POTEX INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~APOTEX~5MG~A~079116~003~AB~Jun 20, 2008~No~RX~APO
TEX INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~APOTEX~10MG~A~079116~004~AB~Jun 20, 2008~No~RX~AP
OTEX INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~AUROBINDO PHARMA LTD~1.25MG~A~091604~001~AB~Jun 8
, 2011~No~RX~AUROBINDO PHARMA LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~AUROBINDO PHARMA LTD~2.5MG~A~091604~002~AB~Jun 8,
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~AUROBINDO PHARMA LTD~5MG~A~091604~003~AB~Jun 8, 2
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~AUROBINDO PHARMA LTD~10MG~A~091604~004~AB~Jun 8,
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~CIPLA~1.25MG~A~077004~001~~Aug 7, 2008~No~DISCN~C
IPLA LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~CIPLA~2.5MG~A~077004~002~~Aug 7, 2008~No~DISCN~CI
PLA LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~CIPLA~5MG~A~077004~003~~Aug 7, 2008~No~DISCN~CIPL
A LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~CIPLA~10MG~A~077004~004~~Aug 7, 2008~No~DISCN~CIP
LA LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~DR REDDYS LABS LTD~1.25MG~A~078191~001~AB~Jun 18,
2008~No~RX~DR REDDYS LABORATORIES LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~DR REDDYS LABS LTD~2.5MG~A~078191~002~AB~Jun 18,
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~DR REDDYS LABS LTD~5MG~A~078191~003~AB~Jun 18, 20
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~DR REDDYS LABS LTD~10MG~A~078191~004~AB~Jun 18, 2
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~INVAGEN PHARMS~1.25MG~A~078745~001~AB~Jun 18, 200
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~INVAGEN PHARMS~2.5MG~A~078745~002~AB~Jun 18, 2008
~No~RX~INVAGEN PHARMACEUTICALS INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~INVAGEN PHARMS~5MG~A~078745~003~AB~Jun 18, 2008~N
o~RX~INVAGEN PHARMACEUTICALS INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~INVAGEN PHARMS~10MG~A~078745~004~AB~Jun 18, 2008~
No~RX~INVAGEN PHARMACEUTICALS INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~LUPIN~1.25MG~A~077626~001~AB~Jun 9, 2008~No~RX~LU
PIN LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~LUPIN~2.5MG~A~077626~002~AB~Jun 9, 2008~No~RX~LUP
IN LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~LUPIN~5MG~A~077626~003~AB~Jun 9, 2008~No~RX~LUPIN
LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~LUPIN~10MG~A~077626~004~AB~Jun 9, 2008~No~RX~LUPI
N LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~RANBAXY LABS LTD~5MG~A~078849~001~~Mar 6, 2009~No
~DISCN~RANBAXY LABORATORIES LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~RANBAXY LABS LTD~10MG~A~078849~002~~Mar 6, 2009~N
o~DISCN~RANBAXY LABORATORIES LTD
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ROXANE~1.25MG~A~077900~001~AB~Jun 18, 2008~No~RX~
ROXANE LABORATORIES INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ROXANE~2.5MG~A~077900~002~AB~Jun 18, 2008~No~RX~R
OXANE LABORATORIES INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ROXANE~5MG~A~077900~003~AB~Jun 18, 2008~No~RX~ROX
ANE LABORATORIES INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ROXANE~10MG~A~077900~004~AB~Jun 18, 2008~No~RX~RO
XANE LABORATORIES INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~SANDOZ~1.25MG~A~077514~001~AB~Jun 18, 2008~No~RX~
SANDOZ INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~SANDOZ~2.5MG~A~077514~002~AB~Jun 18, 2008~No~RX~S
ANDOZ INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~SANDOZ~5MG~A~077514~003~AB~Jun 18, 2008~No~RX~SAN
DOZ INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~SANDOZ~10MG~A~077514~004~AB~Jun 18, 2008~No~RX~SA
NDOZ INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~TEVA PHARMS~1.25MG~A~077470~001~AB~Jun 18, 2008~N
o~RX~TEVA PHARMACEUTICALS USA
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~TEVA PHARMS~2.5MG~A~077470~002~AB~Jun 18, 2008~No
~RX~TEVA PHARMACEUTICALS USA
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~TEVA PHARMS~5MG~A~077470~003~AB~Jun 18, 2008~No~R
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~TEVA PHARMS~10MG~A~077470~004~AB~Jun 18, 2008~No~
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~WATSON LABS~1.25MG~A~076549~001~AB~Oct 24, 2005~N
o~RX~WATSON LABORATORIES INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~WATSON LABS~2.5MG~A~076549~002~AB~Oct 24, 2005~No
~RX~WATSON LABORATORIES INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~WATSON LABS~5MG~A~076549~003~AB~Oct 24, 2005~No~R
X~WATSON LABORATORIES INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~WATSON LABS~10MG~A~076549~004~AB~Oct 24, 2005~No~
RX~WATSON LABORATORIES INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ZYDUS PHARMS USA~1.25MG~A~078832~001~AB~Sep 2, 20
08~No~RX~ZYDUS PHARMACEUTICALS USA INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ZYDUS PHARMS USA~2.5MG~A~078832~002~AB~Sep 2, 200
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ZYDUS PHARMS USA~5MG~A~078832~003~AB~Sep 2, 2008~
No~RX~ZYDUS PHARMACEUTICALS USA INC
RAMIPRIL~CAPSULE;ORAL~RAMIPRIL~ZYDUS PHARMS USA~10MG~A~078832~004~AB~Sep 2, 2008
~No~RX~ZYDUS PHARMACEUTICALS USA INC
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~RANITIDINE HYDROCHLORIDE~DR REDDYS LABS LT
D~EQ 150MG BASE~A~075742~001~AB~Nov 29, 2000~No~RX~DR REDDYS LABORATORIES LTD
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~RANITIDINE HYDROCHLORIDE~DR REDDYS LABS LT
D~EQ 300MG BASE~A~075742~002~AB~Nov 29, 2000~No~RX~DR REDDYS LABORATORIES LTD
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~RANITIDINE HYDROCHLORIDE~MYLAN~EQ 150MG BA
SE~A~075564~001~~Oct 27, 2000~No~DISCN~MYLAN PHARMACEUTICALS INC
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~RANITIDINE HYDROCHLORIDE~MYLAN~EQ 300MG BA
SE~A~075564~002~~Oct 27, 2000~No~DISCN~MYLAN PHARMACEUTICALS INC
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~RANITIDINE HYDROCHLORIDE~SANDOZ~EQ 150MG B

ASE~A~074655~001~AB~Oct 22, 1997~No~RX~SANDOZ INC
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~RANITIDINE HYDROCHLORIDE~SANDOZ~EQ 300MG B
ASE~A~074655~002~AB~Oct 22, 1997~Yes~RX~SANDOZ INC
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~RANITIDINE HYDROCHLORIDE~TEVA~EQ 150MG BAS
E~A~075557~001~~Oct 31, 2003~No~DISCN~TEVA PHARMACEUTICALS USA INC
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~RANITIDINE HYDROCHLORIDE~TEVA~EQ 300MG BAS
E~A~075557~002~~Oct 31, 2003~No~DISCN~TEVA PHARMACEUTICALS USA INC
SILODOSIN~CAPSULE;ORAL~RAPAFLO~WATSON LABS~4MG~N~022206~001~~Oct 8, 2008~Yes~RX~
WATSON LABORATORIES INC
SILODOSIN~CAPSULE;ORAL~RAPAFLO~WATSON LABS~8MG~N~022206~002~~Oct 8, 2008~No~RX~W
ATSON LABORATORIES INC
RIBAVIRIN~CAPSULE;ORAL~REBETOL~MERCK SHARP DOHME~200MG **Indicated for use and c
omarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combinati
on Therapy**~N~020903~001~~Jun 3, 1998~Yes~RX~MERCK SHARP AND DOHME CORP
RIBAVIRIN~CAPSULE;ORAL~REBETOL~MERCK SHARP DOHME~200MG~N~020903~002~AB~Jul 25, 2
001~Yes~RX~MERCK SHARP AND DOHME CORP
SEVELAMER HYDROCHLORIDE~CAPSULE;ORAL~RENAGEL~GENZYME~403MG~N~020926~001~~Oct 30,
1998~No~DISCN~GENZYME CORP
TEMAZEPAM~CAPSULE;ORAL~RESTORIL~MALLINCKRODT INC~7.5MG~N~018163~003~AB~Oct 25, 1
991~No~RX~MALLINCKRODT INC
TEMAZEPAM~CAPSULE;ORAL~RESTORIL~MALLINCKRODT INC~15MG~N~018163~001~AB~Approved P
rior to Jan 1, 1982~No~RX~MALLINCKRODT INC
TEMAZEPAM~CAPSULE;ORAL~RESTORIL~MALLINCKRODT INC~22.5MG~N~018163~004~AB~Nov 2, 2
TEMAZEPAM~CAPSULE;ORAL~RESTORIL~MALLINCKRODT INC~30MG~N~018163~002~AB~Approved P
rior to Jan 1, 1982~Yes~RX~MALLINCKRODT INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~RETET~SOLVAY~250MG~A~061443~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~RETET~SOLVAY~500MG~A~061443~002~~Approve
ZIDOVUDINE~CAPSULE;ORAL~RETROVIR~VIIV HLTHCARE~100MG~N~019655~001~AB~Mar 19, 198
7~Yes~RX~VIIV HEALTHCARE CO
LENALIDOMIDE~CAPSULE;ORAL~REVLIMID~CELGENE~2.5MG~N~021880~005~~Dec 21, 2011~No~R
X~CELGENE CORP
LENALIDOMIDE~CAPSULE;ORAL~REVLIMID~CELGENE~5MG~N~021880~001~~Dec 27, 2005~No~RX~
CELGENE CORP
LENALIDOMIDE~CAPSULE;ORAL~REVLIMID~CELGENE~10MG~N~021880~002~~Dec 27, 2005~No~RX
~CELGENE CORP
LENALIDOMIDE~CAPSULE;ORAL~REVLIMID~CELGENE~15MG~N~021880~003~~Jun 29, 2006~No~RX
~CELGENE CORP
LENALIDOMIDE~CAPSULE;ORAL~REVLIMID~CELGENE~20MG~N~021880~006~~Jun 5, 2013~No~RX~
CELGENE CORP
LENALIDOMIDE~CAPSULE;ORAL~REVLIMID~CELGENE~25MG~N~021880~004~~Jun 29, 2006~Yes~R
X~CELGENE CORP
ATAZANAVIR SULFATE~CAPSULE;ORAL~REYATAZ~BRISTOL MYERS SQUIBB~EQ 100MG BASE **Fed
eral Register determination that product was not discontinued or withdrawn for s
afety or efficacy reasons**~N~021567~001~~Jun 20, 2003~No~DISCN~BRISTOL MYERS SQ
UIBB CO
ATAZANAVIR SULFATE~CAPSULE;ORAL~REYATAZ~BRISTOL MYERS SQUIBB~EQ 150MG BASE~N~021
567~002~AB~Jun 20, 2003~No~RX~BRISTOL MYERS SQUIBB CO
567~003~AB~Jun 20, 2003~No~RX~BRISTOL MYERS SQUIBB CO
567~004~AB~Oct 16, 2006~Yes~RX~BRISTOL MYERS SQUIBB CO
RIBAVIRIN~CAPSULE;ORAL~RIBASPHERE~THREE RIVERS PHARMS~200MG~A~076203~001~AB~Apr
6, 2004~No~RX~THREE RIVERS PHARMACEUTICALS LLC
RIBAVIRIN~CAPSULE;ORAL~RIBAVARIN~AUROBINDO PHARMA~200MG~A~079117~001~AB~Sep 17,
RIBAVIRIN~CAPSULE;ORAL~RIBAVIRIN~SANDOZ~200MG~A~076192~001~AB~Apr 6, 2004~No~RX~
SANDOZ INC
RIBAVIRIN~CAPSULE;ORAL~RIBAVIRIN~TEVA~200MG~A~076277~001~AB~Oct 4, 2004~No~RX~TE
RIBAVIRIN~CAPSULE;ORAL~RIBAVIRIN~ZYDUS PHARMS USA~200MG~A~077224~001~AB~Oct 28,
AURANOFIN~CAPSULE;ORAL~RIDAURA~PROMETHEUS LABS~3MG~N~018689~001~~May 24, 1985~Ye
s~RX~PROMETHEUS LABORATORIES INC
RIFABUTIN~CAPSULE;ORAL~RIFABUTIN~LUPIN LTD~150MG~A~090033~001~AB~Feb 24, 2014~No
~RX~LUPIN LTD
RIFAMPIN~CAPSULE;ORAL~RIFADIN~SANOFI AVENTIS US~150MG~A~062303~001~AB~Approved P
rior to Jan 1, 1982~No~RX~SANOFI AVENTIS US LLC
RIFAMPIN~CAPSULE;ORAL~RIFADIN~SANOFI AVENTIS US~300MG~N~050420~001~AB~Approved P
rior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
ISONIAZID; RIFAMPIN~CAPSULE;ORAL~RIFAMATE~SANOFI AVENTIS US~150MG;300MG~A~061884
~001~~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
RIFAMPIN~CAPSULE;ORAL~RIFAMPIN~LANNETT~150MG~A~065390~001~AB~Mar 28, 2008~No~RX~
LANNETT HOLDINGS INC
RIFAMPIN~CAPSULE;ORAL~RIFAMPIN~LANNETT~300MG~A~065390~002~AB~Mar 28, 2008~No~RX~
RIFAMPIN~CAPSULE;ORAL~RIFAMPIN~LUPIN PHARMS~150MG~A~090034~001~AB~Aug 21, 2013~N
o~RX~LUPIN PHARMACEUTICALS INC
RIFAMPIN~CAPSULE;ORAL~RIFAMPIN~LUPIN PHARMS~300MG~A~090034~002~AB~Aug 21, 2013~N
RIFAMPIN~CAPSULE;ORAL~RIFAMPIN~SANDOZ~150MG~A~064150~002~AB~Jan 2, 1998~No~RX~SA
NDOZ INC
RIFAMPIN~CAPSULE;ORAL~RIFAMPIN~SANDOZ~300MG~A~064150~001~AB~May 28, 1997~No~RX~S
ANDOZ INC
RIFAMPIN~CAPSULE;ORAL~RIFAMPIN~VERSAPHARM~150MG~A~065028~001~AB~Mar 14, 2001~No~
RX~VERSAPHARM INC
RIFAMPIN~CAPSULE;ORAL~RIFAMPIN~VERSAPHARM~300MG~A~065028~002~AB~Mar 14, 2001~No~
RX~VERSAPHARM INC
ISONIAZID; RIFAMPIN~CAPSULE;ORAL~RIFAMPIN AND ISONIAZID~HIKMA INTL PHARMS~150MG;
300MG~A~065221~001~~Jul 29, 2005~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LL
C
RIFAMPIN~CAPSULE;ORAL~RIMACTANE~PROSAM LABS~300MG~N~050429~001~AB~Approved Prior
to Jan 1, 1982~No~RX~PROSAM LABS LLC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~ALEMBIC PHARMS LTD~EQ 1
.5MG BASE~A~091689~001~AB~Jun 12, 2012~No~RX~ALEMBIC PHARMACEUTICALS LTD
MG BASE~A~091689~002~AB~Jun 12, 2012~No~RX~ALEMBIC PHARMACEUTICALS LTD
.5MG BASE~A~091689~003~AB~Jun 12, 2012~No~RX~ALEMBIC PHARMACEUTICALS LTD
MG BASE~A~091689~004~AB~Jun 12, 2012~No~RX~ALEMBIC PHARMACEUTICALS LTD
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~APOTEX INC~EQ 1.5MG BAS
E~A~091072~001~AB~May 16, 2013~No~RX~APOTEX INC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~APOTEX INC~EQ 3MG BASE~
A~091072~002~AB~May 16, 2013~No~RX~APOTEX INC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~APOTEX INC~EQ 4.5MG BAS
E~A~091072~003~AB~May 16, 2013~No~RX~APOTEX INC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~APOTEX INC~EQ 6MG BASE~
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~DR REDDYS LABS INC~EQ 1
.5MG BASE~A~077130~001~AB~Oct 31, 2007~No~RX~DR REDDYS LABORATORIES INC
MG BASE~A~077130~002~AB~Oct 31, 2007~No~RX~DR REDDYS LABORATORIES INC
.5MG BASE~A~077130~003~AB~Oct 31, 2007~No~RX~DR REDDYS LABORATORIES INC
MG BASE~A~077130~004~AB~Oct 31, 2007~No~RX~DR REDDYS LABORATORIES INC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~MACLEODS PHARMS LTD~EQ

1.5MG BASE~A~203148~001~AB~Aug 22, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
3MG BASE~A~203148~002~AB~Aug 22, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
4.5MG BASE~A~203148~003~AB~Aug 22, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
6MG BASE~A~203148~004~AB~Aug 22, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~SUN PHARM INDS~EQ 1.5MG
BASE~A~077131~001~AB~Oct 22, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~SUN PHARM INDS~EQ 3MG B
ASE~A~077131~002~AB~Oct 22, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~SUN PHARM INDS~EQ 4.5MG
BASE~A~077131~003~AB~Oct 22, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~SUN PHARM INDS~EQ 6MG B
ASE~A~077131~004~AB~Oct 22, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~WATSON LABS~EQ 1.5MG BA
SE~A~077129~001~AB~Jan 8, 2008~No~RX~WATSON LABORATORIES INC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~WATSON LABS~EQ 3MG BASE
~A~077129~002~AB~Jan 8, 2008~No~RX~WATSON LABORATORIES INC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~WATSON LABS~EQ 4.5MG BA
SE~A~077129~003~AB~Jan 8, 2008~No~RX~WATSON LABORATORIES INC
RIVASTIGMINE TARTRATE~CAPSULE;ORAL~RIVASTIGMINE TARTRATE~WATSON LABS~EQ 6MG BASE
~A~077129~004~AB~Jan 8, 2008~No~RX~WATSON LABORATORIES INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~ROBITET~WYETH AYERST~250MG~A~061734~001~
~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~ROBITET~WYETH AYERST~500MG~A~061734~002~
~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
CALCITRIOL~CAPSULE;ORAL~ROCALTROL~VALIDUS PHARMS~0.25MCG~N~018044~001~AB~Approve
d Prior to Jan 1, 1982~No~RX~VALIDUS PHARMACEUTICALS LLC
CALCITRIOL~CAPSULE;ORAL~ROCALTROL~VALIDUS PHARMS~0.5MCG~N~018044~002~AB~Approved
Prior to Jan 1, 1982~Yes~RX~VALIDUS PHARMACEUTICALS LLC
METHACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~RONDOMYCIN~MEDPOINTE PHARM HLC~EQ 140MG
BASE~A~060641~001~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTIC
ALS MEDPOINTE HEALTHCARE INC
METHACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~RONDOMYCIN~MEDPOINTE PHARM HLC~EQ 280MG
BASE~A~060641~002~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTIC
ALS MEDPOINTE HEALTHCARE INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~CAPSULE;ORAL~ROXILOX~ROXANE~500MG;5MG~A~0
40061~001~~Jul 3, 1995~No~DISCN~ROXANE LABORATORIES INC
CYANOCOBALAMIN CO-57~CAPSULE;ORAL~RUBRATOPE-57~BRACCO~0.5-1uCi~N~016089~002~~App
roved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
CYANOCOBALAMIN CO-60~CAPSULE;ORAL~RUBRATOPE-60~BRACCO~0.5-1uCi~N~016090~002~~App
CYCLOSPORINE~CAPSULE;ORAL~SANDIMMUNE~NOVARTIS~25MG~N~050625~001~AB2~Mar 2, 1990~
No~RX~NOVARTIS PHARMACEUTICALS CORP
CYCLOSPORINE~CAPSULE;ORAL~SANDIMMUNE~NOVARTIS~50MG~N~050625~003~BX~Nov 23, 1992~
CYCLOSPORINE~CAPSULE;ORAL~SANDIMMUNE~NOVARTIS~100MG~N~050625~002~AB2~Mar 2, 1990
~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~SARAFEM~ELI LILLY AND CO~EQ 10MG BASE~N~01
8936~007~AB2~Jul 6, 2000~No~RX~ELI LILLY AND CO
FLUOXETINE HYDROCHLORIDE~CAPSULE;ORAL~SARAFEM~ELI LILLY AND CO~EQ 20MG BASE~N~01
8936~008~AB2~Jul 6, 2000~Yes~RX~ELI LILLY AND CO
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~ANABOLIC~100MG~A~084422~001
~~Approved Prior to Jan 1, 1982~No~DISCN~ANABOLIC INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~BARR~100MG~A~084225~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~EVERYLIFE~100MG~A~085895~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~HALSEY~100MG~A~084676~001~~

Approved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~IVAX PHARMS~100MG~A~085869~
001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~KV PHARM~100MG~A~085285~001
~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~LANNETT~50MG~A~085909~001~~
Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~LANNETT~100MG~A~085903~001~
~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~PARKE DAVIS~100MG~A~084762~
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~PERRIGO~100MG~A~084561~001~
~Approved Prior to Jan 1, 1982~No~DISCN~L PERRIGO CO
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~PUREPAC PHARM~100MG~A~08586
7~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~VALEANT PHARM INTL~100MG~A~
085477~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTER
NATIONAL
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~VITARINE~100MG~A~085898~001
~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~VITARINE~100MG~A~086273~001
~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~WATSON LABS~100MG~A~085792~
001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~WEST WARD~100MG~A~084926~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~WHITEWORTH TOWN PLSN~100MG~
A~085798~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN IN
C
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECOBARBITAL SODIUM~WYETH AYERST~100MG~A~086390
~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECONAL SODIUM~MARATHON PHARMS~50MG~A~086101~00
1~~Oct 3, 1983~Yes~RX~MARATHON PHARMACEUTICALS LLC
SECOBARBITAL SODIUM~CAPSULE;ORAL~SECONAL SODIUM~MARATHON PHARMS~100MG~A~086101~0
02~~Oct 3, 1983~Yes~RX~MARATHON PHARMACEUTICALS LLC
ACEBUTOLOL HYDROCHLORIDE~CAPSULE;ORAL~SECTRAL~PROMIUS PHARMA~EQ 200MG BASE~N~018
917~001~AB~Dec 28, 1984~No~RX~PROMIUS PHARMA LLC
ACEBUTOLOL HYDROCHLORIDE~CAPSULE;ORAL~SECTRAL~PROMIUS PHARMA~EQ 400MG BASE~N~018
917~003~AB~Dec 28, 1984~Yes~RX~PROMIUS PHARMA LLC
SELEGILINE HYDROCHLORIDE~CAPSULE;ORAL~SELEGILINE HYDROCHLORIDE~APOTEX~5MG~A~0753
21~001~AB~Dec 4, 1998~No~RX~APOTEX INC
SELEGILINE HYDROCHLORIDE~CAPSULE;ORAL~SELEGILINE HYDROCHLORIDE~DAVA PHARMS INC~5
MG~A~075352~001~AB~Nov 30, 1998~No~RX~DAVA PHARMACEUTICALS INC
SELEGILINE HYDROCHLORIDE~CAPSULE;ORAL~SELEGILINE HYDROCHLORIDE~LANNETT HOLDINGS
INC~5MG~A~075145~001~~Sep 15, 2003~No~DISCN~LANNETT HOLDINGS INC
ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE~CAPSULE;ORAL~SEMPREX-D~AUXILIUM PHARM
S LLC~8MG;60MG~N~019806~001~~Mar 25, 1994~Yes~RX~AUXILIUM PHARMACEUTICALS LLC
OXAZEPAM~CAPSULE;ORAL~SERAX~ALPHARMA US PHARMS~10MG~N~015539~002~~Approved Prior
to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
CYCLOSERINE~CAPSULE;ORAL~SEROMYCIN~PURDUE GMP~250MG~A~060593~001~~Approved Prior
to Jan 1, 1982~Yes~RX~PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHAR
MACY
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~SINEQUAN~PFIZER~EQ 10MG BASE~N~016798~003~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC

DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~SINEQUAN~PFIZER~EQ 100MG BASE~N~016798~005~~A
pproved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~SINEQUAN~PFIZER~EQ 150MG BASE~N~016798~007~~A
SODIUM IODIDE I-123~CAPSULE;ORAL~SODIUM IODIDE I 123~CARDINAL HLTH 414~100uCi~N~
018671~001~AA~May 27, 1982~Yes~RX~CARDINAL HEALTH 414
018671~002~AA~May 27, 1982~Yes~RX~CARDINAL HEALTH 414
018671~003~~May 27, 1982~No~DISCN~CARDINAL HEALTH 414
SODIUM IODIDE I-123~CAPSULE;ORAL~SODIUM IODIDE I 123~GE HEALTHCARE~100uCi~N~0176
30~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
SODIUM IODIDE I-123~CAPSULE;ORAL~SODIUM IODIDE I 123~MALLINCKRODT~100uCi~A~07190
9~001~AA~Feb 28, 1989~No~RX~MALLINCKRODT MEDICAL INC
SODIUM IODIDE I-123~CAPSULE;ORAL~SODIUM IODIDE I 123~MALLINCKRODT~200uCi~A~07191
0~001~AA~Feb 28, 1989~No~RX~MALLINCKRODT MEDICAL INC
SODIUM IODIDE I-131~CAPSULE;ORAL~SODIUM IODIDE I 131~CIS~50uCi~N~017316~001~~App
roved Prior to Jan 1, 1982~No~DISCN~CIS BIOINDUSTRIES COMPAGNIE
SODIUM IODIDE I-131~CAPSULE;ORAL~SODIUM IODIDE I 131~CIS~100uCi~N~017316~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~CIS BIOINDUSTRIES COMPAGNIE
SODIUM IODIDE I-131~CAPSULE;ORAL~SODIUM IODIDE I 131~MALLINCKRODT~0.8-100mCi~N~0
16515~002~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
SODIUM IODIDE I-131~CAPSULE;ORAL~SODIUM IODIDE I 131~MALLINCKRODT~0.8-100mCi~N~0
16517~001~~Approved Prior to Jan 1, 1982~Yes~RX~MALLINCKRODT MEDICAL INC
SODIUM IODIDE I-131~CAPSULE;ORAL~SODIUM IODIDE I 131~MALLINCKRODT~15-100uCi~N~01
6517~002~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
SODIUM IODIDE I-131~CAPSULE;ORAL~SODIUM IODIDE I-131~JUBILANT DRAXIMAGE~0.009-0.
1mCi~N~021305~006~~May 19, 2005~No~RX~JUBILANT DRAXIMAGE INC
SODIUM IODIDE I-131~CAPSULE;ORAL~SODIUM IODIDE I-131~JUBILANT DRAXIMAGE~2-200mCi
~N~021305~004~~Nov 18, 2004~No~DISCN~JUBILANT DRAXIMAGE INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~ANABOLIC~100MG~A~084590~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~ANABOLIC INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~ELKINS SINN~100MG~A~08336
8~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~EVERYLIFE~100MG~A~083259~
001~~Approved Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~HALSEY~100MG~A~084677~001
~~Approved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~IVAX SUB TEVA PHARMS~50MG
~A~083461~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC S
UB TEVA PHARMACEUTICALS USA
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~IVAX SUB TEVA PHARMS~100M
SUB TEVA PHARMACEUTICALS USA
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~PARKE DAVIS~100MG~A~08415
6~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~PERRIGO~100MG~A~084560~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~L PERRIGO CO
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~PUREPAC PHARM~100MG~A~083
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~VALEANT PHARM INTL~100MG~
A~083264~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INT
ERNATIONAL
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~WATSON LABS~100MG~A~08579
PENTOBARBITAL SODIUM~CAPSULE;ORAL~SODIUM PENTOBARBITAL~WYETH AYERST~100MG~A~0832

BETA CAROTENE~CAPSULE;ORAL~SOLATENE~ROCHE~30MG~N~017589~001~~Approved Prior to J
an 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
CARISOPRODOL~CAPSULE;ORAL~SOMA~MEDA PHARMS~250MG~N~011792~003~~Approved Prior to
Jan 1, 1982~No~DISCN~MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC
THEOPHYLLINE~CAPSULE;ORAL~SOMOPHYLLIN-T~FISONS~100MG~A~087155~001~~Feb 25, 1985~
No~DISCN~FISONS CORP
ZALEPLON~CAPSULE;ORAL~SONATA~PFIZER~5MG~N~020859~001~AB~Aug 13, 1999~No~RX~PFIZE
R INC
ZALEPLON~CAPSULE;ORAL~SONATA~PFIZER~10MG~N~020859~002~AB~Aug 13, 1999~Yes~RX~PFI
ZER INC
ACITRETIN~CAPSULE;ORAL~SORIATANE~STIEFEL LABS INC~10MG~N~019821~001~AB~Oct 28, 1
996~No~RX~STIEFEL LABORATORIES INC
ACITRETIN~CAPSULE;ORAL~SORIATANE~STIEFEL LABS INC~17.5MG~N~019821~003~AB~Aug 6,
ACITRETIN~CAPSULE;ORAL~SORIATANE~STIEFEL LABS INC~22.5MG~N~019821~004~AB~Aug 6,
ACITRETIN~CAPSULE;ORAL~SORIATANE~STIEFEL LABS INC~25MG~N~019821~002~AB~Oct 28, 1
996~Yes~RX~STIEFEL LABORATORIES INC
ISOTRETINOIN~CAPSULE;ORAL~SOTRET~RANBAXY~10MG~A~076041~001~AB~Dec 24, 2002~No~RX
~RANBAXY PHARMACEUTICALS INC
ISOTRETINOIN~CAPSULE;ORAL~SOTRET~RANBAXY~30MG~A~076503~001~AB~Jun 20, 2003~No~RX
~RANBAXY LABORATORIES LTD
ITRACONAZOLE~CAPSULE;ORAL~SPORANOX~JANSSEN PHARMS~100MG~N~020083~001~AB~Sep 11,
1992~Yes~RX~JANSSEN PHARMACEUTICALS INC
PHENDIMETRAZINE TARTRATE~CAPSULE;ORAL~SPRX-3~SOLVAY~35MG~A~085897~001~~Approved
Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
PHENDIMETRAZINE TARTRATE~CAPSULE;ORAL~STATOBEX~TEVA~35MG~A~085507~001~~Approved
STAVUDINE~CAPSULE;ORAL~STAVUDINE~AUROBINDO PHARMA~15MG~A~077672~003~AB~Dec 29, 2
STAVUDINE~CAPSULE;ORAL~STAVUDINE~HETERO LABS LTD III~15MG~A~078957~001~AB~Dec 29
, 2008~No~RX~HETERO LABS LTD UNIT III
STAVUDINE~CAPSULE;ORAL~STAVUDINE~MATRIX LABS LTD~30MG~A~078775~001~AB~Jan 5, 200
9~No~RX~MATRIX LABORATORIES LTD
STAVUDINE~CAPSULE;ORAL~STAVUDINE~MATRIX LABS LTD~40MG~A~078775~002~AB~Jan 5, 200
9~No~RX~MATRIX LABORATORIES LTD
STAVUDINE~CAPSULE;ORAL~STAVUDINE~MYLAN~15MG~A~079069~001~AB~Dec 29, 2008~No~RX~M

ATOMOXETINE HYDROCHLORIDE~CAPSULE;ORAL~STRATTERA~LILLY~5MG~N~021411~001~~Nov 26,
2002~No~DISCN~ELI LILLY AND CO
ATOMOXETINE HYDROCHLORIDE~CAPSULE;ORAL~STRATTERA~LILLY~10MG~N~021411~002~~Nov 26
, 2002~No~RX~ELI LILLY AND CO
, 2002~Yes~RX~ELI LILLY AND CO
ATOMOXETINE HYDROCHLORIDE~CAPSULE;ORAL~STRATTERA~LILLY~80MG~N~021411~007~~Feb 14
ATOMOXETINE HYDROCHLORIDE~CAPSULE;ORAL~STRATTERA~LILLY~100MG~N~021411~008~~Feb 1
4, 2005~No~RX~ELI LILLY AND CO
SULFINPYRAZONE~CAPSULE;ORAL~SULFINPYRAZONE~BARR~200MG~A~087666~001~~Sep 17, 1982
SULFINPYRAZONE~CAPSULE;ORAL~SULFINPYRAZONE~IVAX PHARMS~200MG~A~087770~001~~Nov 1
SULFINPYRAZONE~CAPSULE;ORAL~SULFINPYRAZONE~PAR PHARM~200MG~A~088934~001~~Sep 6,
1985~No~DISCN~PAR PHARMACEUTICAL INC
SULFINPYRAZONE~CAPSULE;ORAL~SULFINPYRAZONE~VANGARD~200MG~A~088666~001~~Feb 17, 1
984~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~SUMYCIN~APOTHECON~100MG~A~060429~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
SUNITINIB MALATE~CAPSULE;ORAL~SUNITINIB MALATE~MYLAN PHARMS INC~EQ 12.5MG BASE~A
~201275~001~AB~Jan 30, 2014~No~RX~MYLAN PHARMACEUTICALS INC
SUNITINIB MALATE~CAPSULE;ORAL~SUNITINIB MALATE~MYLAN PHARMS INC~EQ 25MG BASE~A~2
SUNITINIB MALATE~CAPSULE;ORAL~SUNITINIB MALATE~MYLAN PHARMS INC~EQ 37.5MG BASE~A
~201275~003~AB~Jan 30, 2014~No~RX~MYLAN PHARMACEUTICALS INC
SUNITINIB MALATE~CAPSULE;ORAL~SUNITINIB MALATE~MYLAN PHARMS INC~EQ 50MG BASE~A~2
CEFIXIME~CAPSULE;ORAL~SUPRAX~LUPIN LTD~400MG~N~203195~001~~Jun 1, 2012~Yes~RX~LU
PIN LTD
TRIMIPRAMINE MALEATE~CAPSULE;ORAL~SURMONTIL~ODYSSEY PHARMS~EQ 25MG BASE~N~016792
~001~AB~Approved Prior to Jan 1, 1982~No~RX~ODYSSEY PHARMACEUTICALS INC
~002~AB~Approved Prior to Jan 1, 1982~No~RX~ODYSSEY PHARMACEUTICALS INC
2~003~AB~Sep 15, 1982~Yes~RX~ODYSSEY PHARMACEUTICALS INC
EFAVIRENZ~CAPSULE;ORAL~SUSTIVA~BRISTOL MYERS SQUIBB~50MG~N~020972~001~~Sep 17, 1
EFAVIRENZ~CAPSULE;ORAL~SUSTIVA~BRISTOL MYERS SQUIBB~100MG **Federal Register det
ermination that product was not discontinued or withdrawn for safety or efficacy
reasons**~N~020972~002~~Sep 17, 1998~No~DISCN~BRISTOL MYERS SQUIBB CO
EFAVIRENZ~CAPSULE;ORAL~SUSTIVA~BRISTOL MYERS SQUIBB~200MG~N~020972~003~~Sep 17,
1998~Yes~RX~BRISTOL MYERS SQUIBB CO

SUNITINIB MALATE~CAPSULE;ORAL~SUTENT~CPPI CV~EQ 12.5MG BASE~N~021938~001~AB~Jan
26, 2006~No~RX~CP PHARMACEUTICALS INTERNATIONAL CV
SUNITINIB MALATE~CAPSULE;ORAL~SUTENT~CPPI CV~EQ 25MG BASE~N~021938~002~AB~Jan 26
, 2006~No~RX~CP PHARMACEUTICALS INTERNATIONAL CV
SUNITINIB MALATE~CAPSULE;ORAL~SUTENT~CPPI CV~EQ 37.5MG BASE~N~021938~004~AB~Mar
31, 2009~No~RX~CP PHARMACEUTICALS INTERNATIONAL CV
SUNITINIB MALATE~CAPSULE;ORAL~SUTENT~CPPI CV~EQ 50MG BASE~N~021938~003~AB~Jan 26
, 2006~Yes~RX~CP PHARMACEUTICALS INTERNATIONAL CV
AMANTADINE HYDROCHLORIDE~CAPSULE;ORAL~SYMADINE~SOLVAY~100MG~A~071000~001~~Sep 4,
1986~No~DISCN~SOLVAY PHARMACEUTICALS
FLUOXETINE HYDROCHLORIDE; OLANZAPINE~CAPSULE;ORAL~SYMBYAX~LILLY~EQ 25MG BASE;EQ
3MG BASE~N~021520~001~AB~Apr 9, 2007~No~RX~ELI LILLY AND CO
6MG BASE~N~021520~002~AB~Dec 24, 2003~No~RX~ELI LILLY AND CO
6MG BASE~N~021520~003~AB~Dec 24, 2003~Yes~RX~ELI LILLY AND CO
AMANTADINE HYDROCHLORIDE~CAPSULE;ORAL~SYMMETREL~ENDO PHARMS~100MG~N~016020~001~~
Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUTICALS INC
ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE~CAPSULE;ORAL~SYNALGOS-DC~CARACO~356
.4MG;30MG;16MG~N~011483~004~~Sep 6, 1983~Yes~RX~CARACO PHARMACEUTICAL LABORATORI
ES LTD
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE~CAPSULE;ORAL~SYNALGOS-DC-A~LE
ITNER PHARMS~356.4MG;30MG;16MG~A~089166~001~~May 14, 1986~No~DISCN~LEITNER PHARM
ACEUTICALS LLC
TRIENTINE HYDROCHLORIDE~CAPSULE;ORAL~SYPRINE~ATON~250MG~N~019194~001~~Nov 8, 198
5~Yes~RX~ATON PHARMA INC
CHLOROTRIANISENE~CAPSULE;ORAL~TACE~SANOFI AVENTIS US~12MG~N~008102~004~~Approved
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~ACCORD HLTHCARE~EQ 0.5MG BASE~A~091195~001~AB
~Aug 31, 2011~No~RX~ACCORD HEALTHCARE INC
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~ACCORD HLTHCARE~EQ 1MG BASE~A~091195~002~AB~A
ug 31, 2011~No~RX~ACCORD HEALTHCARE INC
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~ACCORD HLTHCARE~EQ 5MG BASE~A~091195~003~AB~A
ug 31, 2011~No~RX~ACCORD HEALTHCARE INC
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~DR REDDYS LABS LTD~EQ 0.5MG BASE~A~090509~001
~AB~May 12, 2010~No~RX~DR REDDYS LABORATORIES LTD
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~DR REDDYS LABS LTD~EQ 1MG BASE~A~090509~002~A
B~May 12, 2010~No~RX~DR REDDYS LABORATORIES LTD
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~DR REDDYS LABS LTD~EQ 5MG BASE~A~090509~003~A
B~May 12, 2010~No~RX~DR REDDYS LABORATORIES LTD
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~MYLAN~EQ 0.5MG BASE~A~090596~001~AB~Sep 17, 2
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~MYLAN~EQ 1MG BASE~A~090596~002~AB~Sep 17, 201
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~MYLAN~EQ 5MG BASE~A~090596~003~AB~Sep 17, 201
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~PANACEA BIOTEC LTD~EQ 0.5MG BASE~A~090802~001
~AB~Sep 28, 2012~No~RX~PANACEA BIOTEC LTD
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~PANACEA BIOTEC LTD~EQ 1MG BASE~A~090802~002~A
B~Sep 28, 2012~No~RX~PANACEA BIOTEC LTD
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~PANACEA BIOTEC LTD~EQ 5MG BASE~A~090802~003~A
B~Sep 28, 2012~No~RX~PANACEA BIOTEC LTD

TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~SANDOZ~EQ 0.5MG BASE~A~065461~001~AB~Aug 10,
2009~No~RX~SANDOZ INC
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~SANDOZ~EQ 1MG BASE~A~065461~002~AB~Aug 10, 20
09~No~RX~SANDOZ INC
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~SANDOZ~EQ 5MG BASE~A~065461~003~AB~Aug 10, 20
09~No~RX~SANDOZ INC
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~STRIDES PHARMA~EQ 0.5MG BASE~A~090687~001~AB~
Jul 22, 2014~No~RX~STRIDES PHARMA GLOBAL PTE LTD
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~STRIDES PHARMA~EQ 1MG BASE~A~090687~002~AB~Ju
l 22, 2014~No~RX~STRIDES PHARMA GLOBAL PTE LTD
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~STRIDES PHARMA~EQ 5MG BASE~A~090687~003~AB~Ju
l 22, 2014~No~RX~STRIDES PHARMA GLOBAL PTE LTD
TACROLIMUS~CAPSULE;ORAL~TACROLIMUS~WATSON LABS~EQ 5MG BASE~A~090402~001~~Jul 1,
DABRAFENIB MESYLATE~CAPSULE;ORAL~TAFINLAR~GLAXOSMITHKLINE~EQ 50MG BASE~N~202806~
001~~May 29, 2013~No~RX~GLAXOSMITHKLINE
DABRAFENIB MESYLATE~CAPSULE;ORAL~TAFINLAR~GLAXOSMITHKLINE~EQ 75MG BASE~N~202806~
002~~May 29, 2013~Yes~RX~GLAXOSMITHKLINE
OSELTAMIVIR PHOSPHATE~CAPSULE;ORAL~TAMIFLU~ROCHE~EQ 30MG BASE~N~021087~003~~Jul
2, 2007~No~RX~HOFFMANN LA ROCHE INC
OSELTAMIVIR PHOSPHATE~CAPSULE;ORAL~TAMIFLU~ROCHE~EQ 45MG BASE~N~021087~002~~Jul
OSELTAMIVIR PHOSPHATE~CAPSULE;ORAL~TAMIFLU~ROCHE~EQ 75MG BASE~N~021087~001~~Oct
27, 1999~Yes~RX~HOFFMANN LA ROCHE INC
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~ANCHEN PHARMS~0.4
MG~A~202010~001~AB~Jan 4, 2013~No~RX~ANCHEN PHARMACEUTICALS INC
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~AUROBINDO PHARMA
LTD~0.4MG~A~202433~001~AB~Apr 30, 2013~No~RX~AUROBINDO PHARMA LTD
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~IMPAX LABS~0.4MG~
A~090377~001~AB~Mar 2, 2010~No~RX~IMPAX LABORATORIES INC
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~MYLAN~0.4MG~A~090
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~SANDOZ~0.4MG~A~07
8015~001~AB~Apr 27, 2010~No~RX~SANDOZ INC
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~SUN PHARM INDS LT
D~0.4MG~A~090931~001~AB~Jul 15, 2010~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~SYNTHON PHARMS~0.
4MG~A~078801~001~AB~Apr 27, 2010~No~RX~SYNTHON PHARMACEUTICALS INC
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~TEVA PHARMS~0.4MG
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~WOCKHARDT~0.4MG~A
~078938~001~AB~Apr 27, 2010~No~RX~WOCKHARDT LTD
TAMSULOSIN HYDROCHLORIDE~CAPSULE;ORAL~TAMSULOSIN HYDROCHLORIDE~ZYDUS PHARMS USA
INC~0.4MG~A~078225~001~AB~Apr 27, 2010~No~RX~ZYDUS PHARMACEUTICALS USA INC
TROLEANDOMYCIN~CAPSULE;ORAL~TAO~PFIZER~EQ 250MG BASE~N~050336~002~~Approved Prio
r to Jan 1, 1982~No~DISCN~PFIZER PHARMACEUTICALS INC
BEXAROTENE~CAPSULE;ORAL~TARGRETIN~VALEANT LUXEMBOURG~75MG~N~021055~001~~Dec 29,
1999~Yes~RX~VALEANT PHARMACEUTICALS LUXEMBOURG SARL
NILOTINIB HYDROCHLORIDE MONOHYDRATE~CAPSULE;ORAL~TASIGNA~NOVARTIS~EQ 150MG BASE~
N~022068~002~~Jun 17, 2010~No~RX~NOVARTIS PHARMACEUTICALS CORP
NILOTINIB HYDROCHLORIDE MONOHYDRATE~CAPSULE;ORAL~TASIGNA~NOVARTIS~EQ 200MG BASE~
N~022068~001~~Oct 29, 2007~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
ETRETINATE~CAPSULE;ORAL~TEGISON~ROCHE~10MG~N~019369~001~~Sep 30, 1986~No~DISCN~H
OFFMANN LA ROCHE INC
ETRETINATE~CAPSULE;ORAL~TEGISON~ROCHE~25MG~N~019369~002~~Sep 30, 1986~No~DISCN~H
TEMAZEPAM~CAPSULE;ORAL~TEMAZ~QUANTUM PHARMICS~15MG~A~070564~001~~Oct 15, 1985~No
~DISCN~QUANTUM PHARMICS LTD
TEMAZEPAM~CAPSULE;ORAL~TEMAZ~QUANTUM PHARMICS~30MG~A~070547~001~~Oct 15, 1985~No

TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~ACTAVIS ELIZABETH~15MG~A~071638~001~AB~Aug 7, 1
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~ACTAVIS ELIZABETH~30MG~A~071620~001~AB~Aug 7, 1
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~DURAMED PHARMS BARR~15MG~A~071708~001~~Sep 29,
1988~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~DURAMED PHARMS BARR~30MG~A~071709~001~~Sep 29,
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~MUTUAL PHARM~7.5MG~A~078581~001~AB~Sep 8, 2009~
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~MUTUAL PHARM~15MG~A~071174~001~~Jul 10, 1986~No
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~MUTUAL PHARM~22.5MG~A~071175~002~AB~Sep 14, 200
9~No~RX~MUTUAL PHARMACEUTICAL CO INC
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~MUTUAL PHARM~30MG~A~071175~001~~Jul 10, 1986~No
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~MYLAN~7.5MG~A~070920~002~AB~May 21, 2010~No~RX~
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~MYLAN~15MG~A~070920~004~AB~Jul 7, 1986~No~RX~MY
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~MYLAN~22.5MG~A~070920~003~AB~Jun 12, 2009~No~RX
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~MYLAN~30MG~A~070920~001~AB~Jul 10, 1986~No~RX~M
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~NOVEL LABS INC~7.5MG~A~071457~002~AB~Jun 22, 20
12~No~RX~NOVEL LABORATORIES INC
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~NOVEL LABS INC~15MG~A~071456~001~AB~Apr 21, 198
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~NOVEL LABS INC~22.5MG~A~071457~003~AB~Jun 22, 2
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~NOVEL LABS INC~30MG~A~071457~001~AB~Apr 21, 198
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~SANDOZ~15MG~A~071427~001~AB~Jan 12, 1988~No~RX~
SANDOZ INC
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~SANDOZ~30MG~A~071428~001~AB~Jan 12, 1988~No~RX~
SANDOZ INC
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~USL PHARMA~15MG~A~070489~001~~Jul 7, 1986~No~DI
SCN~USL PHARMA INC
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~USL PHARMA~30MG~A~070490~001~~Jul 7, 1986~No~DI
SCN~USL PHARMA INC
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~WATSON LABS~15MG~A~070383~001~~Mar 23, 1987~No~
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~WATSON LABS~15MG~A~071446~001~~May 21, 1993~No~
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~WATSON LABS~30MG~A~070384~001~~Mar 23, 1987~No~
TEMAZEPAM~CAPSULE;ORAL~TEMAZEPAM~WATSON LABS~30MG~A~071447~001~~May 21, 1993~No~
TEMOZOLOMIDE~CAPSULE;ORAL~TEMODAR~MERCK SHARP DOHME~5MG~N~021029~001~AB~Aug 11,
1999~No~RX~MERCK SHARP AND DOHME CORP
TEMOZOLOMIDE~CAPSULE;ORAL~TEMODAR~MERCK SHARP DOHME~20MG~N~021029~002~AB~Aug 11,
TEMOZOLOMIDE~CAPSULE;ORAL~TEMODAR~MERCK SHARP DOHME~100MG~N~021029~003~AB~Aug 11
, 1999~No~RX~MERCK SHARP AND DOHME CORP
TEMOZOLOMIDE~CAPSULE;ORAL~TEMODAR~MERCK SHARP DOHME~140MG~N~021029~005~AB~Oct 19
TEMOZOLOMIDE~CAPSULE;ORAL~TEMODAR~MERCK SHARP DOHME~180MG~N~021029~006~AB~Oct 19
TEMOZOLOMIDE~CAPSULE;ORAL~TEMODAR~MERCK SHARP DOHME~250MG~N~021029~004~AB~Aug 11
, 1999~Yes~RX~MERCK SHARP AND DOHME CORP

TEMOZOLOMIDE~CAPSULE;ORAL~TEMOZOLOMIDE~BARR~5MG~A~078879~001~AB~Mar 1, 2010~No~R
X~BARR LABORATORIES INC
TEMOZOLOMIDE~CAPSULE;ORAL~TEMOZOLOMIDE~BARR~20MG~A~078879~002~AB~Mar 1, 2010~No~
TEMOZOLOMIDE~CAPSULE;ORAL~TEMOZOLOMIDE~BARR~100MG~A~078879~003~AB~Mar 1, 2010~No
~RX~BARR LABORATORIES INC
TEMOZOLOMIDE~CAPSULE;ORAL~TEMOZOLOMIDE~SUN PHARMA GLOBAL~5MG~A~201742~001~AB~Feb
12, 2014~No~RX~SUN PHARMA GLOBAL FZE
TEMOZOLOMIDE~CAPSULE;ORAL~TEMOZOLOMIDE~SUN PHARMA GLOBAL~20MG~A~201742~002~AB~Fe
b 12, 2014~No~RX~SUN PHARMA GLOBAL FZE
TEMOZOLOMIDE~CAPSULE;ORAL~TEMOZOLOMIDE~SUN PHARMA GLOBAL~100MG~A~201742~003~AB~F
eb 12, 2014~No~RX~SUN PHARMA GLOBAL FZE
ACETAMINOPHEN; BUTALBITAL~CAPSULE;ORAL~TENCON~MALLINCKRODT~650MG;50MG~A~089405~0
01~~May 15, 1990~No~DISCN~MALLINCKRODT CHEMICAL INC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~APOTEX~EQ 1MG BASE~
A~075498~001~AB~Apr 12, 2001~No~RX~APOTEX INC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~APOTEX~EQ 10MG BASE
~A~075498~004~AB~Apr 12, 2001~No~RX~APOTEX INC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~IVAX SUB TEVA PHARM
S~EQ 1MG BASE~A~075614~002~AB~Jan 30, 2001~No~RX~IVAX PHARMACEUTICALS INC SUB TE
VA PHARMACEUTICALS USA
S~EQ 10MG BASE~A~075614~004~AB~Jan 30, 2001~No~RX~IVAX PHARMACEUTICALS INC SUB T
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~JUBILANT CADISTA~EQ
1MG BASE~A~075317~001~AB~Dec 20, 2004~No~RX~JUBILANT CADISTA PHARMACEUTICALS IN
C
C
C
10MG BASE~A~075317~004~AB~Dec 20, 2004~No~RX~JUBILANT CADISTA PHARMACEUTICALS I
NC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~MYLAN~EQ 1MG BASE~A
~075140~002~AB~Feb 11, 2000~No~RX~MYLAN LABORATORIES INC

TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~MYLAN~EQ 10MG BASE~
A~075140~004~AB~Feb 11, 2000~No~RX~MYLAN LABORATORIES INC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~MYLAN TECHNOLOGIES~
EQ 1MG BASE~A~075384~001~~Dec 1, 2000~No~DISCN~MYLAN TECHNOLOGIES INC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~RANBAXY LABS LTD~EQ
1MG BASE~A~076021~001~~Aug 22, 2002~No~DISCN~RANBAXY LABORATORIES LTD
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~SANDOZ~EQ 1MG BASE~
A~074823~001~AB~Mar 30, 1998~No~RX~SANDOZ INC
A~074823~002~AB~Mar 30, 1998~Yes~RX~SANDOZ INC
A~074823~003~AB~Mar 30, 1998~No~RX~SANDOZ INC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~SANDOZ~EQ 10MG BASE
~A~074823~004~AB~Mar 30, 1998~No~RX~SANDOZ INC
TERAZOSIN HYDROCHLORIDE~CAPSULE;ORAL~TERAZOSIN HYDROCHLORIDE~SANDOZ~EQ 10MG BASE
~A~075667~004~~Jul 28, 2000~No~DISCN~SANDOZ INC
OXYTETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TERRAMYCIN~PFIZER~EQ 125MG BASE~N~050
286~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER I
NC
OXYTETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TERRAMYCIN~PFIZER~EQ 250MG BASE~N~050
NC
BENZONATATE~CAPSULE;ORAL~TESSALON~PFIZER~100MG~N~011210~001~AA~Approved Prior to
Jan 1, 1982~No~RX~PFIZER INC
BENZONATATE~CAPSULE;ORAL~TESSALON~PFIZER~200MG~N~011210~003~~Jun 25, 1999~No~DIS
CN~PFIZER INC
METHYLTESTOSTERONE~CAPSULE;ORAL~TESTRED~VALEANT PHARM INTL~10MG~A~083976~001~~Ap
proved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACHEL~ANGUS~250MG~A~060343~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ANGUS CHEMICAL CO
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACHEL~ANGUS~500MG~A~060343~003~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ANGUS CHEMICAL CO
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~ABBOTT~250MG~
A~061802~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMAC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~ABBOTT~500MG~

TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~ELKINS SINN~2
50MG~A~060059~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROB
INS CO INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~FERRANTE~125M
G~A~060173~001~~Approved Prior to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~FERRANTE~250M
G~A~060173~002~~Approved Prior to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~HEATHER~250MG
~A~061148~001~~Approved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~HEATHER~500MG
~A~061148~002~~Approved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~HIKMA PHARMS
LLC~250MG~A~060768~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTI
CALS LLC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~HIKMA PHARMS
LLC~500MG~A~060768~002~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTI
CALS LLC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~IMPAX LABS~10
0MG~A~060469~002~~Approved Prior to Jan 1, 1982~No~RX~IMPAX LABORATORIES INC
0MG~A~060469~001~AB~Approved Prior to Jan 1, 1982~No~RX~IMPAX LABORATORIES INC
0MG~A~060469~003~AB~Approved Prior to Jan 1, 1982~No~RX~IMPAX LABORATORIES INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~IVAX SUB TEVA
PHARMS~250MG~A~060704~001~AB~Approved Prior to Jan 1, 1982~No~RX~IVAX PHARMACEU
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~IVAX SUB TEVA
PHARMS~500MG~A~060704~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~IVAX PHARMACE
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~LABS ATRAL~25
0MG~A~062752~001~~Aug 12, 1988~No~DISCN~LABORATORIOS ATRAL SARL
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~LABS ATRAL~50
0MG~A~062752~002~~Aug 12, 1988~No~DISCN~LABORATORIOS ATRAL SARL
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~MAST MM~250MG
~A~062085~001~~Approved Prior to Jan 1, 1982~No~DISCN~MM MAST AND CO
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~MUTUAL PHARM~
CO INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~MUTUAL PHARM~
CO INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~MYLAN~250MG~A
~060783~001~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~MYLAN~500MG~A
~060783~002~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~PUREPAC PHARM
~250MG~A~060290~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTIC
AL CO
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~PUREPAC PHARM
~500MG~A~060290~002~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTIC
AL CO
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~PVT FORM~250M
G~A~062686~001~~Jul 24, 1986~No~DISCN~PRIVATE FORMULATIONS INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~PVT FORM~500M
G~A~062686~002~~Jul 24, 1986~No~DISCN~PRIVATE FORMULATIONS INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~ROXANE~500MG~
A~061214~002~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~SANDOZ~250MG~
A~061471~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~SUPERPHARM~25

0MG~A~062540~001~~Mar 21, 1985~No~DISCN~SUPERPHARM CORP
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~SUPERPHARM~50
0MG~A~062540~002~~Mar 21, 1985~No~DISCN~SUPERPHARM CORP
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~VALEANT PHARM
INTL~250MG~A~060471~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMAC
EUTICALS INTERNATIONAL
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~VALEANT PHARM
INTL~500MG~A~060471~002~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMAC
EUTICALS INTERNATIONAL
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~WARNER CHILCO
TT~250MG~A~062300~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT IN
C
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~WARNER CHILCO
TT~500MG~A~062300~002~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT IN
C
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~WATSON LABS~2
50MG~A~061837~001~AB~Approved Prior to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
C
C
00MG~A~061837~002~AB~Approved Prior to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
C
C
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~WYETH AYERST~
RIES
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYCLINE HYDROCHLORIDE~WYETH AYERST~
RIES
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYN~PFIPHARMECS~250MG~A~060082~003~
~Approved Prior to Jan 1, 1982~No~DISCN~PFIPHARMECS DIV PFIZER INC
TETRACYCLINE HYDROCHLORIDE~CAPSULE;ORAL~TETRACYN~PFIPHARMECS~500MG~A~060082~004~
~Approved Prior to Jan 1, 1982~No~DISCN~PFIPHARMECS DIV PFIZER INC
TETRACYCLINE PHOSPHATE COMPLEX~CAPSULE;ORAL~TETREX~BRISTOL~EQ 100MG HCL~A~061653
~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTO
L MYERS CO
L MYERS CO
L MYERS CO
TETRACYCLINE PHOSPHATE COMPLEX~CAPSULE;ORAL~TETREX~BRISTOL~EQ 250MG HCL~N~050212
L MYERS CO
L MYERS CO
L MYERS CO
TETRACYCLINE PHOSPHATE COMPLEX~CAPSULE;ORAL~TETREX~BRISTOL~EQ 500MG HCL~N~050212

L MYERS CO
THALIDOMIDE~CAPSULE;ORAL~THALOMID~CELGENE~50MG~N~020785~001~~Jul 16, 1998~No~RX~
CELGENE CORP
THALIDOMIDE~CAPSULE;ORAL~THALOMID~CELGENE~100MG~N~020785~002~~Jan 17, 2003~No~RX
~CELGENE CORP
THALIDOMIDE~CAPSULE;ORAL~THALOMID~CELGENE~150MG~N~020785~004~~Jan 10, 2007~No~RX
~CELGENE CORP
THALIDOMIDE~CAPSULE;ORAL~THALOMID~CELGENE~200MG~N~020785~003~~Jan 17, 2003~Yes~R
X~CELGENE CORP
THEOPHYLLINE~CAPSULE;ORAL~THEOPHYLLINE~KV PHARM~100MG~A~085263~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
THEOPHYLLINE~CAPSULE;ORAL~THEOPHYLLINE~KV PHARM~200MG~A~085263~002~~Approved Pri
THEOPHYLLINE~CAPSULE;ORAL~THEOPHYLLINE~SCHERER RP~100MG~A~084731~002~~Nov 7, 198
6~No~DISCN~RP SCHERER NORTH AMERICA
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~AM THERAP~1MG~A~071884~001~~Aug 12, 1987~No
~DISCN~AMERICAN THERAPEUTICS INC
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~AM THERAP~10MG~A~071887~001~~Aug 12, 1987~N
o~DISCN~AMERICAN THERAPEUTICS INC
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~AM THERAP~20MG~A~072200~001~~Dec 17, 1987~N
o~DISCN~AMERICAN THERAPEUTICS INC
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~MYLAN~1MG~A~071093~002~AB~Jun 23, 1987~No~R
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~MYLAN~10MG~A~071093~001~AB~Jun 23, 1987~No~
RX~MYLAN PHARMACEUTICALS INC
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~SANDOZ~1MG~A~071610~001~AB~Jun 24, 1987~No~
RX~SANDOZ INC
RX~SANDOZ INC
RX~SANDOZ INC
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~SANDOZ~10MG~A~071530~001~AB~Jun 24, 1987~No
~RX~SANDOZ INC
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~WATSON LABS~1MG~A~070600~001~~Jun 5, 1987~N
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~WATSON LABS~2MG~A~071626~001~~Jun 25, 1987~
THIOTHIXENE~CAPSULE;ORAL~THIOTHIXENE~WATSON LABS~10MG~A~071628~001~~Jun 25, 1987
~No~DISCN~WATSON LABORATORIES INC

TRIMETHOBENZAMIDE HYDROCHLORIDE~CAPSULE;ORAL~TIGAN~KING PHARMS~300MG~N~017531~00
6~AB~Dec 13, 2001~Yes~RX~KING PHARMACEUTICALS INC
DOFETILIDE~CAPSULE;ORAL~TIKOSYN~PFIZER~0.125MG~N~020931~001~~Oct 1, 1999~No~RX~P
FIZER PHARMACEUTICALS PRODUCTION CORP LTD
DOFETILIDE~CAPSULE;ORAL~TIKOSYN~PFIZER~0.25MG~N~020931~002~~Oct 1, 1999~No~RX~PF
IZER PHARMACEUTICALS PRODUCTION CORP LTD
DOFETILIDE~CAPSULE;ORAL~TIKOSYN~PFIZER~0.5MG~N~020931~003~~Oct 1, 1999~Yes~RX~PF
IZER PHARMACEUTICALS PRODUCTION CORP LTD
LEVOTHYROXINE SODIUM~CAPSULE;ORAL~TIROSINT~INST BIOCHIMIQUE~0.013MG~N~022121~001
~~Aug 1, 2007~No~RX~INSTITUTE BIOCHIMIQUE SA (IBSA)
LEVOTHYROXINE SODIUM~CAPSULE;ORAL~TIROSINT~INSTITUT BIOCHIMIQUE~0.025MG~N~021924
~002~~Oct 13, 2006~No~RX~INSTITUT BIOCHIMIQUE SA IBSA
LEVOTHYROXINE SODIUM~CAPSULE;ORAL~TIROSINT~INSTITUT BIOCHIMIQUE~0.05MG~N~021924~
003~~Oct 13, 2006~No~RX~INSTITUT BIOCHIMIQUE SA IBSA
LEVOTHYROXINE SODIUM~CAPSULE;ORAL~TIROSINT~INSTITUT BIOCHIMIQUE~0.1MG~N~021924~0
05~~Oct 13, 2006~No~RX~INSTITUT BIOCHIMIQUE SA IBSA
LEVOTHYROXINE SODIUM~CAPSULE;ORAL~TIROSINT~INSTITUT BIOCHIMIQUE~0.15MG~N~021924~
007~~Oct 13, 2006~Yes~RX~INSTITUT BIOCHIMIQUE SA IBSA
INDOMETHACIN~CAPSULE;ORAL~TIVORBEX~IROKO PHARMS LLC~20MG~N~204768~001~~Feb 24, 2
014~No~RX~IROKO PHARMACEUTICALS LLC
INDOMETHACIN~CAPSULE;ORAL~TIVORBEX~IROKO PHARMS LLC~40MG~N~204768~002~~Feb 24, 2
014~Yes~RX~IROKO PHARMACEUTICALS LLC
TIZANIDINE HYDROCHLORIDE~CAPSULE;ORAL~TIZANIDINE HYDROCHLORIDE~APOTEX INC~EQ 2MG
BASE~A~078868~001~AB~Feb 3, 2012~No~RX~APOTEX INC
TIZANIDINE HYDROCHLORIDE~CAPSULE;ORAL~TIZANIDINE HYDROCHLORIDE~MYLAN PHARMS INC~
EQ 2MG BASE~A~091502~001~AB~Nov 9, 2012~No~RX~MYLAN PHARMACEUTICALS INC
IMIPRAMINE PAMOATE~CAPSULE;ORAL~TOFRANIL-PM~MALLINCKRODT INC~EQ 75MG HCL~N~01709
0~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~MALLINCKRODT INC
90~004~AB~Approved Prior to Jan 1, 1982~No~RX~MALLINCKRODT INC
TOLMETIN SODIUM~CAPSULE;ORAL~TOLECTIN DS~ORTHO MCNEIL JANSSEN~EQ 400MG BASE~N~01
8084~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL JANSSEN PHARMACEUT
ICALS INC
TOLMETIN SODIUM~CAPSULE;ORAL~TOLMETIN SODIUM~ACTAVIS ELIZABETH~EQ 400MG BASE~A~0
73308~001~~Jan 24, 1992~No~DISCN~ACTAVIS ELIZABETH LLC
TOLMETIN SODIUM~CAPSULE;ORAL~TOLMETIN SODIUM~IVAX SUB TEVA PHARMS~EQ 400MG BASE~
A~073392~001~~Jan 24, 1992~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUT
ICALS USA
TOLMETIN SODIUM~CAPSULE;ORAL~TOLMETIN SODIUM~MUTUAL PHARM~EQ 400MG BASE~A~073311
~001~~Nov 27, 1991~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
TOLMETIN SODIUM~CAPSULE;ORAL~TOLMETIN SODIUM~MYLAN~EQ 400MG BASE~A~073393~001~AB
~May 27, 1993~No~RX~MYLAN PHARMACEUTICALS INC
TOLMETIN SODIUM~CAPSULE;ORAL~TOLMETIN SODIUM~SANDOZ~EQ 400MG BASE~A~073462~001~~
Apr 30, 1992~No~DISCN~SANDOZ INC
TOLMETIN SODIUM~CAPSULE;ORAL~TOLMETIN SODIUM~TEVA~EQ 400MG BASE~A~073290~001~AB~
Nov 27, 1991~Yes~RX~TEVA PHARMACEUTICALS USA INC
TOLMETIN SODIUM~CAPSULE;ORAL~TOLMETIN SODIUM~TEVA~EQ 400MG BASE~A~073519~001~~Ma
y 29, 1992~No~DISCN~TEVA PHARMACEUTICALS USA INC
TOPIRAMATE~CAPSULE;ORAL~TOPAMAX~JANSSEN PHARMS~15MG~N~020844~001~AB~Oct 26, 1998
~No~RX~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~CAPSULE;ORAL~TOPAMAX~JANSSEN PHARMS~25MG~N~020844~002~AB~Oct 26, 1998
~Yes~RX~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~CAPSULE;ORAL~TOPAMAX SPRINKLE~JANSSEN PHARMS~50MG~N~020844~003~~Oct 2
6, 1998~No~DISCN~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~BARR~15MG~A~076448~001~~Apr 15, 2009~No~DISCN
~BARR LABORATORIES INC
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~BARR~25MG~A~076448~002~~Apr 15, 2009~No~DISCN
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~MYLAN~15MG~A~078418~001~AB~Oct 14, 2009~No~RX
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~MYLAN~25MG~A~078418~002~AB~Oct 14, 2009~No~RX
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~SANDOZ~15MG~A~079206~001~~Oct 14, 2009~No~DIS
CN~SANDOZ INC
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~SANDOZ~25MG~A~079206~002~~Oct 14, 2009~No~DIS
CN~SANDOZ INC
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~TEVA~15MG~A~076575~001~AB~Apr 17, 2009~No~RX~
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~TEVA~25MG~A~076575~002~AB~Apr 17, 2009~No~RX~
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~WATSON LABS~15MG~A~077868~001~AB~Apr 15, 2009
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~WATSON LABS~25MG~A~077868~002~AB~Apr 15, 2009
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~ZYDUS PHARMS USA INC~15MG~A~078877~001~AB~Oct
TOPIRAMATE~CAPSULE;ORAL~TOPIRAMATE~ZYDUS PHARMS USA INC~25MG~A~078877~002~AB~Oct
AMPICILLIN/AMPICILLIN TRIHYDRATE~CAPSULE;ORAL~TOTACILLIN~GLAXOSMITHKLINE~EQ 250M
G BASE~A~060060~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~TRANXENE~RECORDATI RARE~3.75MG~N~017105~001
~~Approved Prior to Jan 1, 1982~No~DISCN~RECORDATI RARE DISEASES INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~TRANXENE~RECORDATI RARE~7.5MG~N~017105~002~
~Approved Prior to Jan 1, 1982~No~DISCN~RECORDATI RARE DISEASES INC
CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~TRANXENE~RECORDATI RARE~15MG~N~017105~003~~
Approved Prior to Jan 1, 1982~No~DISCN~RECORDATI RARE DISEASES INC
OXPRENOLOL HYDROCHLORIDE~CAPSULE;ORAL~TRASICOR~NOVARTIS~20MG~N~018166~001~~Dec 2

OXPRENOLOL HYDROCHLORIDE~CAPSULE;ORAL~TRASICOR~NOVARTIS~160MG~N~018166~004~~Dec
TRETINOIN~CAPSULE;ORAL~TRETINOIN~ANCHEN PHARMS~10MG~A~201687~001~AB~Oct 24, 2012
~No~RX~ANCHEN PHARMACEUTICALS INC
TRETINOIN~CAPSULE;ORAL~TRETINOIN~BARR LABS INC~10MG~A~077684~001~AB~Jun 22, 2007
~Yes~RX~BARR LABORATORIES INC
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE~CAPSULE;ORAL~TREZIX~WRASER PH
ARMS LLC~320.5MG;30MG;16MG~A~204785~001~~Nov 26, 2014~No~RX~WRASER PHARMACEUTICA
LS LLC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~CAPSULE;ORAL~TRIAD~MALLINCKRODT~325MG;50MG;4
0MG~A~089023~001~~Jun 19, 1985~No~DISCN~MALLINCKRODT CHEMICAL INC
HYDROCHLOROTHIAZIDE; TRIAMTERENE~CAPSULE;ORAL~TRIAMTERENE AND HYDROCHLOROTHIAZID
E~BARR~25MG;37.5MG~A~074970~001~~Jan 6, 1998~No~DISCN~BARR LABORATORIES INC
E~DURAMED PHARMS BARR~25MG;37.5MG~A~075052~001~AB~Jun 18, 1999~No~RX~DURAMED PHA
RMACEUTICALS INC SUB BARR LABORATORIES INC
E~IVAX SUB TEVA PHARMS~25MG;50MG~A~074259~001~AB~Mar 30, 1995~No~RX~IVAX PHARMAC
EUTICALS INC SUB TEVA PHARMACEUTICALS USA
E~LANNETT HOLDINGS INC~25MG;37.5MG~A~201407~001~AB~Dec 9, 2011~No~RX~LANNETT HOL
DINGS INC
E~MYLAN~25MG;37.5MG~A~074701~001~AB~Jun 7, 1996~No~RX~MYLAN PHARMACEUTICALS INC
E~NOVARTIS~25MG;37.5MG~A~074857~001~~Sep 9, 1997~No~DISCN~NOVARTIS PHARMACEUTICA
LS CORP
E~SANDOZ~25MG;37.5MG~A~074821~001~AB~Jun 5, 1997~No~RX~SANDOZ INC
E~SANDOZ~25MG;50MG~A~073191~001~AB~Jul 31, 1991~Yes~RX~SANDOZ INC
E~VITARINE~25MG;50MG~A~071737~001~~Feb 12, 1988~No~DISCN~VITARINE PHARMACEUTICAL
S INC
ACETAMINOPHEN; BUTALBITAL~CAPSULE;ORAL~TRIAPRIN~DUNHALL~325MG;50MG~A~089268~001~
~Jul 2, 1987~No~DISCN~DUNHALL PHARMACEUTICALS INC
FENOFIBRATE~CAPSULE;ORAL~TRICOR (MICRONIZED)~ABBVIE~67MG~N~019304~002~~Feb 9, 19
98~No~DISCN~ABBVIE INC
FENOFIBRATE~CAPSULE;ORAL~TRICOR (MICRONIZED)~ABBVIE~134MG~N~019304~003~~Jun 30,
FENOFIBRATE~CAPSULE;ORAL~TRICOR (MICRONIZED)~ABBVIE~200MG~N~019304~004~~Jun 30,
TRIMETHADIONE~CAPSULE;ORAL~TRIDIONE~ABBVIE~300MG~N~005856~005~~Approved Prior to
TRIMETHOBENZAMIDE HYDROCHLORIDE~CAPSULE;ORAL~TRIMETHOBENZAMIDE HYDROCHLORIDE~GAV
IS PHARMS~300MG~A~076546~001~AB~Aug 20, 2003~No~RX~GAVIS PHARMACEUTICALS LLC
TRIMETHOBENZAMIDE HYDROCHLORIDE~CAPSULE;ORAL~TRIMETHOBENZAMIDE HYDROCHLORIDE~MUT
UAL PHARMA~300MG~A~076570~001~AB~Aug 28, 2003~No~RX~MUTUAL PHARMACAL CO
TRIMIPRAMINE MALEATE~CAPSULE;ORAL~TRIMIPRAMINE MALEATE~MIKAH PHARMA~EQ 25MG BASE
~A~077361~001~AB~Aug 2, 2006~No~RX~MIKAH PHARMA LLC
TRIMIPRAMINE MALEATE~CAPSULE;ORAL~TRIMIPRAMINE MALEATE~MIKAH PHARMA~EQ 50MG BASE
~A~077361~002~AB~Aug 2, 2006~No~RX~MIKAH PHARMA LLC
TRIMIPRAMINE MALEATE~CAPSULE;ORAL~TRIMIPRAMINE MALEATE~MIKAH PHARMA~EQ 100MG BAS
E~A~077361~003~AB~Aug 2, 2006~No~RX~MIKAH PHARMA LLC
TRIMIPRAMINE MALEATE~CAPSULE;ORAL~TRIMIPRAMINE MALEATE~USL PHARMA~EQ 25MG BASE~A
~071283~001~~Dec 8, 1987~No~DISCN~USL PHARMA INC
TRIMIPRAMINE MALEATE~CAPSULE;ORAL~TRIMIPRAMINE MALEATE~USL PHARMA~EQ 50MG BASE~A
~071284~001~~Dec 8, 1987~No~DISCN~USL PHARMA INC
TRIMIPRAMINE MALEATE~CAPSULE;ORAL~TRIMIPRAMINE MALEATE~USL PHARMA~EQ 100MG BASE~
A~071285~001~~Dec 8, 1987~No~DISCN~USL PHARMA INC

AMOXICILLIN~CAPSULE;ORAL~TRIMOX~APOTHECON~250MG~A~061885~001~~Approved Prior to
Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL MYERS SQUIBB CO
AMOXICILLIN~CAPSULE;ORAL~TRIMOX~APOTHECON~250MG~A~063099~001~~Mar 20, 1992~No~DI
SCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
AMOXICILLIN~CAPSULE;ORAL~TRIMOX~APOTHECON~500MG~A~063099~002~~Mar 20, 1992~No~DI
ACETAMINOPHEN; CODEINE PHOSPHATE~CAPSULE;ORAL~TYLENOL W/ CODEINE NO. 3~ORTHO MCN
EIL PHARM~300MG;30MG~A~087422~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO
MCNEIL PHARMACEUTICAL INC
ACETAMINOPHEN; CODEINE PHOSPHATE~CAPSULE;ORAL~TYLENOL W/ CODEINE NO. 4~ORTHO MCN
EIL PHARM~300MG;60MG~A~087421~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO
MCNEIL PHARMACEUTICAL INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~CAPSULE;ORAL~TYLOX~JANSSEN PHARMS~500MG;5
MG~A~088790~001~~Dec 12, 1984~No~DISCN~JANSSEN PHARMACEUTICALS INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE~CAPSULE;ORAL~TYL
OX~ORTHO MCNEIL PHARM~500MG;4.5MG;0.38MG~A~085375~001~~Approved Prior to Jan 1,
1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~CAPSULE;ORAL~TYLOX-325~ORTHO MCNEIL PHARM
~325MG;5MG~A~088246~001~~Nov 8, 1984~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
CEFADROXIL/CEFADROXIL HEMIHYDRATE~CAPSULE;ORAL~ULTRACEF~BRISTOL~EQ 500MG BASE~A~
062378~001~~Mar 16, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
NAFCILLIN SODIUM~CAPSULE;ORAL~UNIPEN~WYETH AYERST~EQ 250MG BASE~N~050111~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
DOXYLAMINE SUCCINATE~CAPSULE;ORAL~UNISOM~PFIZER~25MG~N~019440~001~~Feb 5, 1986~N
o~DISCN~PFIZER LABORATORIES DIV PFIZER INC
URACIL MUSTARD~CAPSULE;ORAL~URACIL MUSTARD~SHIRE~1MG~N~012892~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
URSODIOL~CAPSULE;ORAL~URSODIOL~COREPHARMA~300MG~A~077895~001~AB~Jul 27, 2006~No~
RX~COREPHARMA LLC
URSODIOL~CAPSULE;ORAL~URSODIOL~EPIC PHARMA~300MG~A~075517~001~AB~Mar 14, 2000~No
~RX~EPIC PHARMA LLC
URSODIOL~CAPSULE;ORAL~URSODIOL~LANNETT~300MG~A~079082~001~AB~Dec 15, 2008~No~RX~
URSODIOL~CAPSULE;ORAL~URSODIOL~MYLAN~300MG~A~090530~001~AB~Feb 17, 2010~No~RX~MY
URSODIOL~CAPSULE;ORAL~URSODIOL~TEVA PHARMS~300MG~A~075592~001~AB~May 25, 2000~No
AMOXICILLIN~CAPSULE;ORAL~UTIMOX~PARKE DAVIS~250MG~A~062107~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
AMOXICILLIN~CAPSULE;ORAL~UTIMOX~PARKE DAVIS~500MG~A~062107~002~~Approved Prior t
ETHINAMATE~CAPSULE;ORAL~VALMID~DISTA~500MG~N~009750~001~~Approved Prior to Jan 1
, 1982~No~DISCN~DISTA PRODUCTS CO DIV ELI LILLY AND CO
VALPROIC ACID~CAPSULE;ORAL~VALPROIC ACID~BANNER LIFE SCIENCES~250MG~A~073484~001
~AB~Jun 29, 1993~No~RX~BANNER LIFE SCIENCES LLC
VALPROIC ACID~CAPSULE;ORAL~VALPROIC ACID~CATALENT~250MG~A~073229~001~AB~Oct 29,
1991~No~RX~CATALENT PHARMA SOLUTIONS LLC
VALPROIC ACID~CAPSULE;ORAL~VALPROIC ACID~PAR PHARM~250MG~A~070431~001~~Feb 28, 1
VALPROIC ACID~CAPSULE;ORAL~VALPROIC ACID~SCHERER RP~250MG~A~070195~001~~Jul 2, 1

987~No~DISCN~RP SCHERER NORTH AMERICA DIV RP SCHERER CORP
VALPROIC ACID~CAPSULE;ORAL~VALPROIC ACID~SUN PHARM INDS LTD~250MG~A~091037~001~A
B~Feb 22, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
VALPROIC ACID~CAPSULE;ORAL~VALPROIC ACID~USL PHARMA~250MG~A~070631~001~~Jun 11,
1987~No~DISCN~USL PHARMA INC
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOCIN HYDROCHLORIDE~ANI PHARMS INC~EQ 1
25MG BASE~N~050606~001~AB~Apr 15, 1986~No~RX~ANI PHARMACEUTICALS INC
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOCIN HYDROCHLORIDE~ANI PHARMS INC~EQ 2
50MG BASE~N~050606~002~AB~Apr 15, 1986~Yes~RX~ANI PHARMACEUTICALS INC
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~AKORN~EQ 125MG BA
SE~A~065478~001~AB~Apr 9, 2012~No~RX~AKORN INC
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~AKORN~EQ 250MG BA
SE~A~065478~002~AB~Apr 9, 2012~No~RX~AKORN INC
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~FRESENIUS KABI US
A~EQ 125MG BASE~A~065453~001~AB~Jun 18, 2012~No~RX~FRESENIUS KABI USA LLC
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~FRESENIUS KABI US
A~EQ 250MG BASE~A~065453~002~AB~Jun 18, 2012~No~RX~FRESENIUS KABI USA LLC
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~LUPIN LTD~EQ 125M
G BASE~A~090439~001~AB~Jan 28, 2015~No~RX~LUPIN LTD
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~LUPIN LTD~EQ 250M
G BASE~A~090439~002~AB~Jan 28, 2015~No~RX~LUPIN LTD
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~STRIDES PHARMA~EQ
125MG BASE~A~065490~001~AB~Apr 9, 2012~No~RX~STRIDES PHARMA GLOBAL PTE LTD
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~STRIDES PHARMA~EQ
250MG BASE~A~065490~002~AB~Apr 9, 2012~No~RX~STRIDES PHARMA GLOBAL PTE LTD
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~WATSON LABS~EQ 12
5MG BASE~A~065510~001~AB~Apr 9, 2012~No~RX~WATSON LABORATORIES INC
VANCOMYCIN HYDROCHLORIDE~CAPSULE;ORAL~VANCOMYCIN HYDROCHLORIDE~WATSON LABS~EQ 25
0MG BASE~A~065510~002~AB~Apr 9, 2012~No~RX~WATSON LABORATORIES INC
OXAMNIQUINE~CAPSULE;ORAL~VANSIL~PFIZER~250MG~N~018069~001~~Approved Prior to Jan
1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
ICOSAPENT ETHYL~CAPSULE;ORAL~VASCEPA~AMARIN PHARMS~1GM~N~202057~001~~Jul 26, 201
2~Yes~RX~AMARIN PHARMACEUTICALS IRELAND LTD
CEPHRADINE~CAPSULE;ORAL~VELOSEF~APOTHECON~250MG~A~061764~001~~Approved Prior to
CEPHRADINE~CAPSULE;ORAL~VELOSEF~APOTHECON~500MG~A~061764~002~~Approved Prior to
CEPHRADINE~CAPSULE;ORAL~VELOSEF '250'~ERSANA~250MG~N~050548~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ERSANA INC SUB ER SQUIBB AND SONS
CEPHRADINE~CAPSULE;ORAL~VELOSEF '500'~ERSANA~500MG~N~050548~002~~Approved Prior
to Jan 1, 1982~No~DISCN~ERSANA INC SUB ER SQUIBB AND SONS
ETOPOSIDE~CAPSULE;ORAL~VEPESID~DAVA PHARMS INC~50MG~N~019557~001~~Dec 30, 1986~N
o~DISCN~DAVA PHARMACEUTICALS INC
ETOPOSIDE~CAPSULE;ORAL~VEPESID~DAVA PHARMS INC~100MG~N~019557~002~~Dec 30, 1986~
No~DISCN~DAVA PHARMACEUTICALS INC
HETACILLIN POTASSIUM~CAPSULE;ORAL~VERSAPEN-K~BRISTOL~EQ 225MG AMPICIL~A~061396~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL
MYERS CO
HETACILLIN POTASSIUM~CAPSULE;ORAL~VERSAPEN-K~BRISTOL~EQ 450MG AMPICIL~A~061396~0
MYERS CO
TRETINOIN~CAPSULE;ORAL~VESANOID~ROCHE~10MG~N~020438~001~~Nov 22, 1995~No~DISCN~H
VITAMIN A PALMITATE~CAPSULE;ORAL~VI-DOM-A~BAYER PHARMS~EQ 50,000 UNITS BASE~A~08
0972~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~VIBRAMYCIN~PFIZER~EQ 50MG BASE~N~050007~001~AB~
Approved Prior to Jan 1, 1982~No~RX~PFIZER LABORATORIES DIV PFIZER INC
DOXYCYCLINE HYCLATE~CAPSULE;ORAL~VIBRAMYCIN~PFIZER~EQ 100MG BASE~N~050007~002~AB
~Approved Prior to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC
BOCEPREVIR~CAPSULE;ORAL~VICTRELIS~MERCK SHARP DOHME~200MG~N~202258~001~~May 13,

METHYLTESTOSTERONE~CAPSULE;ORAL~VIRILON~STAR PHARMS FL~10MG~A~087750~001~~Nov 24
, 1982~No~DISCN~STAR PHARMACEUTICALS INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~VISTARIL~PFIZER~EQ 25MG HCL~N~011459~002~AB~App
roved Prior to Jan 1, 1982~No~RX~PFIZER LABORATORIES DIV PFIZER INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~VISTARIL~PFIZER~EQ 50MG HCL~N~011459~004~AB~App
roved Prior to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC
HYDROXYZINE PAMOATE~CAPSULE;ORAL~VISTARIL~PFIZER~EQ 100MG HCL~N~011459~006~~Appr
oved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~BANNER PHARMACAPS~EQ 50,000 UNITS BAS
E~A~080702~001~~Approved Prior to Jan 1, 1982~No~DISCN~BANNER PHARMACAPS INC
VITAMIN A~CAPSULE;ORAL~VITAMIN A~BANNER PHARMACAPS~50,000USP UNITS~A~083973~001~
~Approved Prior to Jan 1, 1982~No~DISCN~BANNER PHARMACAPS INC
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~BRISTOL MYERS SQUIBB~EQ 50,000 UNITS
BASE~A~080860~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB C
O
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~CHASE CHEM~EQ 50,000 UNITS BASE~A~080
746~001~~Approved Prior to Jan 1, 1982~No~DISCN~CHASE CHEMICAL CO LP
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~CHASE CHEM~EQ 50,000 UNITS BASE~A~083
207~001~~Approved Prior to Jan 1, 1982~No~DISCN~CHASE CHEMICAL CO LP
VITAMIN A~CAPSULE;ORAL~VITAMIN A~CHASE CHEM~50,000 IU~A~083351~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~CHASE CHEMICAL CO LP
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~ELKINS SINN~EQ 50,000 UNITS BASE~A~08
5479~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO IN
C
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~EVERYLIFE~EQ 50,000 UNITS BASE~A~0809
43~001~~Approved Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~EVERYLIFE~EQ 50,000 UNITS BASE~A~0831
14~001~~Approved Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
VITAMIN A~CAPSULE;ORAL~VITAMIN A~EVERYLIFE~50,000 IU~A~083134~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~EVERYLIFE
VITAMIN A~CAPSULE;ORAL~VITAMIN A~IMPAX LABS~50,000USP UNITS~A~080952~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~IMPAX LABS~EQ 50,000 UNITS BASE~A~080
953~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~IMPAX LABS~EQ 50,000 UNITS BASE~A~080
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~IVAX SUB TEVA PHARMS~EQ 50,000 UNITS
BASE~A~083035~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS I
NC SUB TEVA PHARMACEUTICALS USA
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~IVAX SUB TEVA PHARMS~EQ 50,000 UNITS
BASE~A~083190~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS I
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~MK LABS~EQ 25,000 UNITS BASE~A~083457
~002~~Approved Prior to Jan 1, 1982~No~DISCN~MK LABORATORIES INC
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~MK LABS~EQ 50,000 UNITS BASE~A~083457
~001~~Approved Prior to Jan 1, 1982~No~DISCN~MK LABORATORIES INC
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~WEST WARD~EQ 50,000 UNITS BASE~A~0809
67~001~~Approved Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
VITAMIN A~CAPSULE;ORAL~VITAMIN A~WEST WARD~50,000USP UNITS~A~080985~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A~WHARTON LABS~EQ 50,000 UNITS BASE~A~0
83665~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHARTON LABORATORIES INC DIV U
S ETHICALS
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A PALMITATE~ARCUM~EQ 50,000 UNITS BASE~
A~083311~001~~Approved Prior to Jan 1, 1982~No~DISCN~ARCUM PHARMACEUTICAL CORP
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A PALMITATE~ARCUM~EQ 50,000 UNITS BASE~
A~083321~001~~Approved Prior to Jan 1, 1982~No~DISCN~ARCUM PHARMACEUTICAL CORP
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A PALMITATE~BANNER PHARMACAPS~EQ 50,000
UNITS BASE~A~083948~001~~Approved Prior to Jan 1, 1982~No~DISCN~BANNER PHARMACA

PS INC
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A PALMITATE~BANNER PHARMACAPS~EQ 50,000
UNITS BASE~A~083981~001~~Approved Prior to Jan 1, 1982~No~DISCN~BANNER PHARMACA
PS INC
VITAMIN A PALMITATE~CAPSULE;ORAL~VITAMIN A SOLUBILIZED~TEVA~EQ 50,000 UNITS BASE
~A~080921~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA I
NC
ERGOCALCIFEROL~CAPSULE;ORAL~VITAMIN D~BANNER LIFE SCIENCES~50,000 IU~A~080704~00
1~AA~Approved Prior to Jan 1, 1982~No~RX~BANNER LIFE SCIENCES LLC
ERGOCALCIFEROL~CAPSULE;ORAL~VITAMIN D~CHASE CHEM~50,000 IU~A~080747~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~CHASE CHEMICAL CO LP
ERGOCALCIFEROL~CAPSULE;ORAL~VITAMIN D~EVERYLIFE~50,000 IU~A~080956~001~~Approved
Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
ERGOCALCIFEROL~CAPSULE;ORAL~VITAMIN D~IMPAX LABS~50,000 IU~A~080951~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
ERGOCALCIFEROL~CAPSULE;ORAL~VITAMIN D~LANNETT~50,000 IU~A~080825~001~~Approved P
rior to Jan 1, 1982~No~DISCN~LANNETT CO INC
ERGOCALCIFEROL~CAPSULE;ORAL~VITAMIN D~VITARINE~50,000 IU~A~084053~001~~Approved
Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
ERGOCALCIFEROL~CAPSULE;ORAL~VITAMIN D~WEST WARD~50,000 IU~A~083102~001~~Approved
Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
LISDEXAMFETAMINE DIMESYLATE~CAPSULE;ORAL~VYVANSE~SHIRE DEVELOPMENT~10MG~N~021977
~007~~Oct 30, 2014~No~RX~SHIRE DEVELOPMENT INC
~004~~Dec 10, 2007~No~RX~SHIRE DEVELOPMENT INC
~001~~Feb 23, 2007~No~RX~SHIRE DEVELOPMENT INC
~002~~Feb 23, 2007~No~RX~SHIRE DEVELOPMENT INC
~003~~Feb 23, 2007~Yes~RX~SHIRE DEVELOPMENT INC
NIACIN~CAPSULE;ORAL~WAMPOCAP~MEDPOINTE PHARM HLC~500MG~N~011073~003~~Approved Pr
ior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
COLESEVELAM HYDROCHLORIDE~CAPSULE;ORAL~WELCHOL~DAIICHI SANKYO~375MG~N~021141~001
~~May 26, 2000~No~DISCN~DAIICHI SANKYO INC
AMOXICILLIN~CAPSULE;ORAL~WYMOX~WYETH AYERST~250MG~A~062120~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
AMOXICILLIN~CAPSULE;ORAL~WYMOX~WYETH AYERST~500MG~A~062120~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
PHENDIMETRAZINE TARTRATE~CAPSULE;ORAL~X-TROZINE~SHIRE RICHWOOD~35MG~A~087394~001
~~Sep 22, 1982~No~DISCN~SHIRE RICHWOOD INC
CRIZOTINIB~CAPSULE;ORAL~XALKORI~PF PRISM CV~200MG~N~202570~001~~Aug 26, 2011~No~
RX~PF PRISM CV
CRIZOTINIB~CAPSULE;ORAL~XALKORI~PF PRISM CV~250MG~N~202570~002~~Aug 26, 2011~Yes
~RX~PF PRISM CV
ORLISTAT~CAPSULE;ORAL~XENICAL~HOFFMANN LA ROCHE~120MG~N~020766~001~~Apr 23, 1999
~Yes~RX~HOFFMANN LA ROCHE INC
ENZALUTAMIDE~CAPSULE;ORAL~XTANDI~ASTELLAS~40MG~N~203415~001~~Aug 31, 2012~Yes~RX
~ASTELLAS PHARMA US INC
ZALEPLON~CAPSULE;ORAL~ZALEPLON~AUROBINDO PHARMA~5MG~A~078829~001~AB~Jun 6, 2008~
No~RX~AUROBINDO PHARMA LTD
ZALEPLON~CAPSULE;ORAL~ZALEPLON~AUROBINDO PHARMA~10MG~A~078829~002~AB~Jun 6, 2008
ZALEPLON~CAPSULE;ORAL~ZALEPLON~CIPLA LTD~5MG~A~077505~001~AB~Jun 20, 2008~No~RX~
CIPLA LTD
ZALEPLON~CAPSULE;ORAL~ZALEPLON~CIPLA LTD~10MG~A~077505~002~AB~Jun 20, 2008~No~RX

~CIPLA LTD
ZALEPLON~CAPSULE;ORAL~ZALEPLON~HIKMA PHARMS LLC~5MG~A~078147~001~AB~Nov 25, 2008
~No~RX~HIKMA PHARMACEUTICALS LLC
ZALEPLON~CAPSULE;ORAL~ZALEPLON~HIKMA PHARMS LLC~10MG~A~078147~002~AB~Nov 25, 200
8~No~RX~HIKMA PHARMACEUTICALS LLC
ZALEPLON~CAPSULE;ORAL~ZALEPLON~MYLAN~5MG~A~077238~001~AB~Jun 6, 2008~No~RX~MYLAN
PHARMACEUTICALS INC
ZALEPLON~CAPSULE;ORAL~ZALEPLON~MYLAN~10MG~A~077238~002~AB~Jun 6, 2008~No~RX~MYLA
ZALEPLON~CAPSULE;ORAL~ZALEPLON~ORCHID HLTHCARE~5MG~A~090374~001~AB~Sep 17, 2009~
No~RX~ORCHID HEALTHCARE
ZALEPLON~CAPSULE;ORAL~ZALEPLON~ORCHID HLTHCARE~10MG~A~090374~002~AB~Sep 17, 2009
~No~RX~ORCHID HEALTHCARE
ZALEPLON~CAPSULE;ORAL~ZALEPLON~ROXANE~5MG~A~077237~001~AB~Jun 6, 2008~No~RX~ROXA
NE LABORATORIES INC
ZALEPLON~CAPSULE;ORAL~ZALEPLON~ROXANE~10MG~A~077237~002~AB~Jun 6, 2008~No~RX~ROX
ZALEPLON~CAPSULE;ORAL~ZALEPLON~SANDOZ~5MG~A~078095~001~~Jun 6, 2008~No~DISCN~SAN
DOZ INC
ZALEPLON~CAPSULE;ORAL~ZALEPLON~SANDOZ~10MG~A~078095~002~~Jun 6, 2008~No~DISCN~SA
NDOZ INC
ZALEPLON~CAPSULE;ORAL~ZALEPLON~TEVA PHARMS~5MG~A~077239~001~AB~Jun 6, 2008~No~RX
~TEVA PHARMACEUTICALS USA
ZALEPLON~CAPSULE;ORAL~ZALEPLON~TEVA PHARMS~10MG~A~077239~002~AB~Jun 6, 2008~No~R
ZALEPLON~CAPSULE;ORAL~ZALEPLON~UNICHEM~5MG~A~078989~001~AB~Jun 6, 2008~No~RX~UNI
CHEM LABORATORIES LTD
ZALEPLON~CAPSULE;ORAL~ZALEPLON~UNICHEM~10MG~A~078989~002~AB~Jun 6, 2008~No~RX~UN
ICHEM LABORATORIES LTD
ZALEPLON~CAPSULE;ORAL~ZALEPLON~UPSHER SMITH~5MG~A~078706~001~AB~Jun 6, 2008~No~R
X~UPSHER SMITH LABORATORIES INC
ZALEPLON~CAPSULE;ORAL~ZALEPLON~UPSHER SMITH~10MG~A~078706~002~AB~Jun 6, 2008~No~
RX~UPSHER SMITH LABORATORIES INC
TIZANIDINE HYDROCHLORIDE~CAPSULE;ORAL~ZANAFLEX~ACORDA~EQ 2MG BASE~N~021447~001~A
B~Aug 29, 2002~No~RX~ACORDA THERAPEUTICS INC
B~Aug 29, 2002~No~RX~ACORDA THERAPEUTICS INC
B~Aug 29, 2002~Yes~RX~ACORDA THERAPEUTICS INC
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~ZANTAC 150~GLAXOSMITHKLINE~EQ 150MG BASE~N
~020095~001~~Mar 8, 1994~No~DISCN~GLAXOSMITHKLINE
RANITIDINE HYDROCHLORIDE~CAPSULE;ORAL~ZANTAC 300~GLAXOSMITHKLINE~EQ 300MG BASE~N
~020095~002~~Mar 8, 1994~No~DISCN~GLAXOSMITHKLINE
ETHOSUXIMIDE~CAPSULE;ORAL~ZARONTIN~PARKE DAVIS~250MG~N~012380~001~AB~Approved Pr
ior to Jan 1, 1982~Yes~RX~PARKE DAVIS DIV WARNER LAMBERT CO
MIGLUSTAT~CAPSULE;ORAL~ZAVESCA~ACTELION PHARMS LTD~100MG~N~021348~001~~Jul 31, 2
003~Yes~RX~ACTELION PHARMACEUTICALS LTD
OXAZEPAM~CAPSULE;ORAL~ZAXOPAM~QUANTUM PHARMICS~10MG~A~070650~001~~Mar 1, 1988~No
OMEPRAZOLE; SODIUM BICARBONATE~CAPSULE;ORAL~ZEGERID~SANTARUS INC~20MG;1.1GM~N~02
1849~001~AB~Feb 27, 2006~No~RX~SANTARUS INC
OMEPRAZOLE; SODIUM BICARBONATE~CAPSULE;ORAL~ZEGERID~SANTARUS INC~40MG;1.1GM~N~02
1849~002~AB~Feb 27, 2006~Yes~RX~SANTARUS INC
OMEPRAZOLE; SODIUM BICARBONATE~CAPSULE;ORAL~ZEGERID OTC~MSD CONSUMER~20MG;1.1GM~
N~022281~001~~Dec 1, 2009~Yes~OTC~MSD CONSUMER CARE INC
PARICALCITOL~CAPSULE;ORAL~ZEMPLAR~ABBVIE~1MCG~N~021606~001~AB~May 26, 2005~No~RX

~ABBVIE INC
PARICALCITOL~CAPSULE;ORAL~ZEMPLAR~ABBVIE~2MCG~N~021606~002~AB~May 26, 2005~No~RX
~ABBVIE INC
PARICALCITOL~CAPSULE;ORAL~ZEMPLAR~ABBVIE~4MCG~N~021606~003~AB~May 26, 2005~Yes~R
X~ABBVIE INC
ISOTRETINOIN~CAPSULE;ORAL~ZENATANE~DR REDDYS LABS LTD~10MG~A~202099~001~AB~Mar 2
ISOTRETINOIN~CAPSULE;ORAL~ZENATANE~DR REDDYS LABS LTD~30MG~A~202099~004~AB~Feb 2
STAVUDINE~CAPSULE;ORAL~ZERIT~BRISTOL MYERS SQUIBB~5MG~N~020412~001~~Jun 24, 1994
~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
STAVUDINE~CAPSULE;ORAL~ZERIT~BRISTOL MYERS SQUIBB~15MG~N~020412~002~AB~Jun 24, 1
994~No~RX~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
994~Yes~RX~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
ZIDOVUDINE~CAPSULE;ORAL~ZIDOVUDINE~AUROBINDO PHARMA LTD~100MG~A~078128~001~AB~Ma
r 27, 2006~No~RX~AUROBINDO PHARMA LTD INC
ZIDOVUDINE~CAPSULE;ORAL~ZIDOVUDINE~CIPLA LTD~100MG~A~078349~001~AB~May 23, 2007~
No~RX~CIPLA LTD
ZIPRASIDONE HYDROCHLORIDE~CAPSULE;ORAL~ZIPRASIDONE HYDROCHLORIDE~APOTEX CORP~EQ
20MG BASE~A~077561~001~AB~Mar 2, 2012~No~RX~APOTEX CORP
ZIPRASIDONE HYDROCHLORIDE~CAPSULE;ORAL~ZIPRASIDONE HYDROCHLORIDE~DR REDDYS LABS
INC~EQ 20MG BASE~A~077565~001~AB~Mar 2, 2012~No~RX~DR REDDYS LABORATORIES INC
ZIPRASIDONE HYDROCHLORIDE~CAPSULE;ORAL~ZIPRASIDONE HYDROCHLORIDE~LUPIN PHARMS~EQ
20MG BASE~A~077560~001~AB~Mar 2, 2012~No~RX~LUPIN PHARMACEUTICALS INC
ZIPRASIDONE HYDROCHLORIDE~CAPSULE;ORAL~ZIPRASIDONE HYDROCHLORIDE~MYLAN PHARMS IN
C~EQ 20MG BASE~A~202395~001~AB~Oct 10, 2013~No~RX~MYLAN PHARMACEUTICALS INC
ZIPRASIDONE HYDROCHLORIDE~CAPSULE;ORAL~ZIPRASIDONE HYDROCHLORIDE~SANDOZ INC~EQ 2

0MG BASE~A~077562~001~AB~Jun 1, 2012~No~RX~SANDOZ INC
ZIPRASIDONE HYDROCHLORIDE~CAPSULE;ORAL~ZIPRASIDONE HYDROCHLORIDE~WOCKHARDT LTD~E
Q 20MG BASE~A~090348~001~AB~Sep 5, 2012~No~RX~WOCKHARDT LTD
DICLOFENAC POTASSIUM~CAPSULE;ORAL~ZIPSOR~DEPOMED INC~25MG~N~022202~001~~Jun 16,
2009~Yes~RX~DEPOMED INC
AZITHROMYCIN~CAPSULE;ORAL~ZITHROMAX~PFIZER~EQ 250MG BASE **Federal Register dete
rmination that product was not discontinued or withdrawn for safety or efficacy
reasons**~N~050670~001~~Nov 1, 1991~No~DISCN~PFIZER CHEMICALS DIV PFIZER INC
VORINOSTAT~CAPSULE;ORAL~ZOLINZA~MERCK~100MG~N~021991~001~~Oct 6, 2006~Yes~RX~MER
CK AND CO INC
ZONISAMIDE~CAPSULE;ORAL~ZONEGRAN~EISAI INC~25MG~N~020789~003~AB~Aug 22, 2003~No~
RX~EISAI INC
ZONISAMIDE~CAPSULE;ORAL~ZONEGRAN~EISAI INC~50MG~N~020789~002~AB~Aug 22, 2003~No~
RX~EISAI INC
ZONISAMIDE~CAPSULE;ORAL~ZONEGRAN~EISAI INC~100MG~N~020789~001~AB~Mar 27, 2000~Ye
s~RX~EISAI INC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~ANI PHARMS INC~25MG~A~077639~001~~Dec 22, 200
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~APOTEX INC~25MG~A~077642~001~AB~Dec 22, 2005~
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~APOTEX INC~50MG~A~077642~002~AB~Dec 22, 2005~
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~APOTEX INC~100MG~A~077642~003~AB~Dec 22, 2005
~No~RX~APOTEX INC ETOBICOKE SITE
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~BANNER LIFE SCIENCES~25MG~A~077813~001~AB~Aug
16, 2006~No~RX~BANNER LIFE SCIENCES LLC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~BANNER LIFE SCIENCES~50MG~A~077813~002~AB~Aug
16, 2006~No~RX~BANNER LIFE SCIENCES LLC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~BANNER LIFE SCIENCES~100MG~A~077813~003~AB~Au
g 16, 2006~No~RX~BANNER LIFE SCIENCES LLC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~COREPHARMA~25MG~A~077876~001~~Feb 21, 2007~No
~DISCN~COREPHARMA LLC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~COREPHARMA~50MG~A~077876~002~~Feb 21, 2007~No
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~COREPHARMA~100MG~A~077876~003~~Feb 21, 2007~N
o~DISCN~COREPHARMA LLC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~DR REDDYS LABS LTD~25MG~A~077645~002~~Sep 29,
2006~No~DISCN~DR REDDYS LABORATORIES LTD

ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~DR REDDYS LABS LTD~50MG~A~077645~003~~Sep 29,
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~DR REDDYS LABS LTD~100MG~A~077645~001~~Dec 22
, 2005~No~DISCN~DR REDDYS LABORATORIES LTD
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~GLENMARK GENERICS~25MG~A~077651~001~AB~Jan 30
, 2006~No~RX~GLENMARK GENERICS INC USA
, 2006~No~RX~GLENMARK GENERICS INC USA
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~INVAGEN PHARMS~25MG~A~077869~001~AB~May 31, 2
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~INVAGEN PHARMS~50MG~A~077869~002~AB~May 31, 2
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~INVAGEN PHARMS~100MG~A~077869~003~AB~May 31,
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MUTUAL PHARM~25MG~A~077635~001~~Dec 22, 2005~
No~DISCN~MUTUAL PHARMACEUTICAL CO INC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MUTUAL PHARM~50MG~A~077635~002~~Dec 22, 2005~
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MUTUAL PHARM~100MG~A~077635~003~~Dec 22, 2005
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MYLAN~25MG~A~077637~001~AB~Dec 22, 2005~No~RX
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MYLAN~50MG~A~077637~002~AB~Dec 22, 2005~No~RX
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MYLAN~100MG~A~077637~003~AB~Dec 22, 2005~No~R
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MYLAN PHARMS INC~25MG~A~077647~001~AB~Dec 22,
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MYLAN PHARMS INC~50MG~A~077647~002~AB~Dec 22,
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~MYLAN PHARMS INC~100MG~A~077647~003~AB~Dec 22
, 2005~No~RX~MYLAN PHARMACEUTICALS INC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~ROXANE~25MG~A~077648~001~~Dec 22, 2005~No~DIS
CN~ROXANE LABORATORIES INC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~ROXANE~50MG~A~077648~002~~Dec 22, 2005~No~DIS
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~ROXANE~100MG~A~077648~003~~Dec 22, 2005~No~DI
SCN~ROXANE LABORATORIES INC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~SANDOZ~25MG~A~077644~001~~Dec 22, 2005~No~DIS
CN~SANDOZ INC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~SANDOZ~50MG~A~077644~002~~Dec 22, 2005~No~DIS
CN~SANDOZ INC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~SANDOZ~100MG~A~077644~003~~Dec 22, 2005~No~DI
SCN~SANDOZ INC
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~SUN PHARM INDS (IN)~25MG~A~077634~001~AB~Mar
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~WATSON LABS~25MG~A~077650~001~~Apr 20, 2006~N
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~WATSON LABS~50MG~A~077650~002~~Apr 20, 2006~N
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~WATSON LABS~100MG~A~077650~003~~Apr 20, 2006~
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~WOCKHARDT~25MG~A~077636~003~AB~Jul 27, 2006~N
o~RX~WOCKHARDT LTD
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~WOCKHARDT~50MG~A~077636~002~AB~Jul 27, 2006~N
o~RX~WOCKHARDT LTD
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~WOCKHARDT~100MG~A~077636~001~AB~Dec 22, 2005~
No~RX~WOCKHARDT LTD
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~ZYDUS PHARMS USA~25MG~A~077625~001~AB~Oct 16,
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~ZYDUS PHARMS USA~50MG~A~077625~002~AB~Oct 16,
ZONISAMIDE~CAPSULE;ORAL~ZONISAMIDE~ZYDUS PHARMS USA~100MG~A~077625~003~AB~Oct 16
, 2006~No~RX~ZYDUS PHARMACEUTICALS USA INC
DICLOFENAC~CAPSULE;ORAL~ZORVOLEX~IROKO PHARMS LLC~18MG~N~204592~001~~Oct 18, 201
3~No~RX~IROKO PHARMACEUTICALS LLC
DICLOFENAC~CAPSULE;ORAL~ZORVOLEX~IROKO PHARMS LLC~35MG~N~204592~002~~Oct 18, 201
ACYCLOVIR~CAPSULE;ORAL~ZOVIRAX~DELCOR ASSET~200MG~N~018828~001~AB~Jan 25, 1985~Y
es~RX~DELCOR ASSET CORP
CERITINIB~CAPSULE;ORAL~ZYKADIA~NOVARTIS PHARMS CORP~150MG~N~205755~001~~Apr 29,
2014~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
CHLORHEXIDINE GLUCONATE~CLOTH;TOPICAL~CHLORHEXIDINE GLUCONATE~SAGE PRODS~2%~N~02
1669~001~~Apr 25, 2005~Yes~OTC~SAGE PRODUCTS INC
ALPRAZOLAM~CONCENTRATE;ORAL~ALPRAZOLAM~ROXANE~1MG/ML~A~074312~001~~Oct 31, 1993~
Yes~RX~ROXANE LABORATORIES INC
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~CHLORPROMAZINE HYDROCHLORIDE~ACTAV
IS MID ATLANTIC~100MG/ML~A~086863~001~~Approved Prior to Jan 1, 1982~No~DISCN~AC
TAVIS MID ATLANTIC LLC
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~CHLORPROMAZINE HYDROCHLORIDE~PHARM
ASSOC~30MG/ML~A~040231~001~~Dec 30, 1999~No~DISCN~PHARMACEUTICAL ASSOC INC DIV
BEACH PRODUCTS
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~CHLORPROMAZINE HYDROCHLORIDE~PHARM
ASSOC~100MG/ML~A~040224~001~~Jan 26, 1999~No~DISCN~PHARMACEUTICAL ASSOC INC DIV
BEACH PRODUCTS
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~CHLORPROMAZINE HYDROCHLORIDE~WOCKH
ARDT~30MG/ML~A~087032~001~~Jul 8, 1982~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS)
AG
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~CHLORPROMAZINE HYDROCHLORIDE~WOCKH
ARDT~100MG/ML~A~087053~001~~Approved Prior to Jan 1, 1982~No~DISCN~WOCKHARDT EU
OPERATIONS (SWISS) AG
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~CHLORPROMAZINE HYDROCHLORIDE INTEN
SOL~ROXANE~30MG/ML~A~088157~001~~Apr 27, 1983~No~DISCN~ROXANE LABORATORIES INC
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~CHLORPROMAZINE HYDROCHLORIDE INTEN
SOL~ROXANE~100MG/ML~A~088158~001~~Apr 27, 1983~No~DISCN~ROXANE LABORATORIES INC
PROCHLORPERAZINE EDISYLATE~CONCENTRATE;ORAL~COMPAZINE~GLAXOSMITHKLINE~EQ 10MG BA
SE/ML~N~011276~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CROMOLYN SODIUM~CONCENTRATE;ORAL~CROMOLYN SODIUM~GENERA PHARMS~100MG/5ML~A~09095
4~001~~Dec 18, 2009~No~DISCN~GENERA PHARMACEUTICALS LLC
CROMOLYN SODIUM~CONCENTRATE;ORAL~CROMOLYN SODIUM~MICRO LABS LTD INDIA~100MG/5ML~
A~202745~001~AA~Apr 4, 2013~No~RX~MICRO LABS LTD INDIA
CROMOLYN SODIUM~CONCENTRATE;ORAL~CROMOLYN SODIUM~PACK PHARMS LLC~100MG/5ML~A~202
583~001~AA~Oct 27, 2011~No~RX~PACK PHARMACEUTICALS LLC
DEXAMETHASONE~CONCENTRATE;ORAL~DEXAMETHASONE INTENSOL~ROXANE~1MG/ML~A~088252~001
~~Sep 1, 1983~Yes~RX~ROXANE LABORATORIES INC
DIAZEPAM~CONCENTRATE;ORAL~DIAZEPAM~LANNETT HOLDINGS INC~5MG/ML~A~204433~001~AA~A
pr 14, 2014~No~RX~LANNETT HOLDINGS INC
DIAZEPAM~CONCENTRATE;ORAL~DIAZEPAM INTENSOL~ROXANE~5MG/ML~A~071415~001~AA~Apr 3,
DOXEPIN HYDROCHLORIDE~CONCENTRATE;ORAL~DOXEPIN HYDROCHLORIDE~PHARM ASSOC~EQ 10MG
BASE/ML~A~075924~001~~Jan 15, 2004~No~DISCN~PHARMACEUTICAL ASSOC INC
DOXEPIN HYDROCHLORIDE~CONCENTRATE;ORAL~DOXEPIN HYDROCHLORIDE~SILARX~EQ 10MG BASE
/ML~A~074721~001~AA~Dec 29, 1998~No~RX~SILARX PHARMACEUTICALS INC
DOXEPIN HYDROCHLORIDE~CONCENTRATE;ORAL~DOXEPIN HYDROCHLORIDE~TEVA PHARMS~EQ 10MG

BASE/ML~A~071609~001~AA~Nov 9, 1987~Yes~RX~TEVA PHARMACEUTICALS USA
DOXEPIN HYDROCHLORIDE~CONCENTRATE;ORAL~DOXEPIN HYDROCHLORIDE~WOCKHARDT~EQ 10MG B
ASE/ML~A~071918~001~AA~Jul 20, 1988~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
AMITRIPTYLINE HYDROCHLORIDE~CONCENTRATE;ORAL~ENDEP~ROCHE~40MG/ML~A~085749~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
FLUPHENAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~FLUPHENAZINE HYDROCHLORIDE~PHARM ASS
OC~5MG/ML~A~074725~001~~Sep 16, 1996~Yes~RX~PHARMACEUTICAL ASSOC INC DIV BEACH P
RODUCTS
FLUPHENAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~FLUPHENAZINE HYDROCHLORIDE~TEVA PHAR
MS~5MG/ML~A~073058~001~~Aug 30, 1991~No~DISCN~TEVA PHARMACEUTICALS USA
CROMOLYN SODIUM~CONCENTRATE;ORAL~GASTROCROM~MEDA PHARMS~100MG/5ML~N~020479~001~A
A~Feb 29, 1996~Yes~RX~MEDA PHARMACEUTICALS INC
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALDOL~ORTHO MCNEIL~EQ 2MG BASE/ML~N~015922
~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALOPERIDOL~ALPHARMA~EQ 2MG BASE/ML~A~07031
8~001~~Apr 11, 1986~No~DISCN~ALPHARMA USPD INC
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALOPERIDOL~MORTON GROVE~EQ 2MG BASE/ML~A~0
70710~001~~Mar 7, 1986~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALOPERIDOL~PHARM ASSOC~EQ 2MG BASE/ML~A~07
3037~001~AA~Feb 26, 1993~No~RX~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALOPERIDOL~SCS~EQ 2MG BASE/ML~A~070726~001
~~Jun 10, 1986~No~DISCN~SCS PHARMACEUTICALS
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALOPERIDOL~SILARX~EQ 2MG BASE/ML~A~073364~
001~AA~Sep 28, 1993~No~RX~SILARX PHARMACEUTICALS INC
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALOPERIDOL~TEVA~EQ 2MG BASE/ML~A~071015~00
1~~Aug 25, 1987~No~DISCN~TEVA PHARMACEUTICALS USA INC
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALOPERIDOL~TEVA PHARMS~EQ 2MG BASE/ML~A~07
1617~001~AA~Dec 1, 1988~Yes~RX~TEVA PHARMACEUTICALS USA
HALOPERIDOL LACTATE~CONCENTRATE;ORAL~HALOPERIDOL INTENSOL~ROXANE~EQ 2MG BASE/ML~
IMIPRAMINE HYDROCHLORIDE~CONCENTRATE;ORAL~IMIPRAMINE HYDROCHLORIDE~NOVARTIS~25MG
/ML~A~086765~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICAL
S CORP
LORAZEPAM~CONCENTRATE;ORAL~LORAZEPAM~AMNEAL PHARMS~2MG/ML~A~091383~001~AA~Dec 23
, 2009~No~RX~AMNEAL PHARMACEUTICALS
LORAZEPAM~CONCENTRATE;ORAL~LORAZEPAM~HI-TECH PHARMA CO~2MG/ML~A~200169~001~AA~Ja
n 30, 2012~No~RX~HI-TECH PHARMACAL CO INC
LORAZEPAM~CONCENTRATE;ORAL~LORAZEPAM~LUPIN LTD~2MG/ML~A~091407~001~AA~Feb 19, 20
13~No~RX~LUPIN LTD
LORAZEPAM~CONCENTRATE;ORAL~LORAZEPAM~PADDOCK LLC~2MG/ML~A~079244~001~AA~Apr 28,
2009~No~RX~PADDOCK LABORATORIES LLC
LORAZEPAM~CONCENTRATE;ORAL~LORAZEPAM~PHARM ASSOC~2MG/ML~A~090260~001~AA~Jun 15,
2010~No~RX~PHARMACEUTICAL ASSOC INC
LORAZEPAM~CONCENTRATE;ORAL~LORAZEPAM INTENSOL~ROXANE~2MG/ML~A~072755~001~AA~Jun
28, 1991~Yes~RX~ROXANE LABORATORIES INC
LOXAPINE HYDROCHLORIDE~CONCENTRATE;ORAL~LOXITANE C~WATSON LABS~EQ 25MG BASE/ML~N
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~MELLARIL~NOVARTIS~30MG/ML~N~011808~0
12~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~MELLARIL~NOVARTIS~100MG/ML~N~011808~
METHADONE HYDROCHLORIDE~CONCENTRATE;ORAL~METHADONE HYDROCHLORIDE~ROXANE~10MG/ML~
A~040180~001~AA~Apr 30, 1998~No~RX~ROXANE LABORATORIES INC
METHADONE HYDROCHLORIDE~CONCENTRATE;ORAL~METHADONE HYDROCHLORIDE~VISTAPHARM~10MG
/ML~A~040088~001~AA~Nov 30, 1994~No~RX~VISTAPHARM INC
METHADONE HYDROCHLORIDE~CONCENTRATE;ORAL~METHADONE HYDROCHLORIDE INTENSOL~ROXANE
~10MG/ML~A~089897~001~AA~Sep 6, 1988~No~RX~ROXANE LABORATORIES INC
METHADONE HYDROCHLORIDE~CONCENTRATE;ORAL~METHADOSE~MALLINCKRODT~10MG/ML~N~017116
~002~AA~Approved Prior to Jan 1, 1982~Yes~RX~MALLINCKRODT CHEMICAL INC
METOCLOPRAMIDE HYDROCHLORIDE~CONCENTRATE;ORAL~METOCLOPRAMIDE INTENSOL~ROXANE~EQ

10MG BASE/ML~A~072995~001~~Jan 30, 1992~No~DISCN~ROXANE LABORATORIES INC
MOLINDONE HYDROCHLORIDE~CONCENTRATE;ORAL~MOBAN~ENDO PHARMS~20MG/ML~N~017938~001~
~Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUTICALS INC
THIOTHIXENE HYDROCHLORIDE~CONCENTRATE;ORAL~NAVANE~PFIZER~EQ 5MG BASE/ML~N~016758
~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER INC
LEVOMETHADYL ACETATE HYDROCHLORIDE~CONCENTRATE;ORAL~ORLAAM~ROXANE~10MG/ML **Fede
ral Register determination that product was not discontinued or withdrawn for sa
fety or efficacy reasons**~N~020315~001~~Jul 9, 1993~No~DISCN~ROXANE LABORATORIE
S INC
FLUPHENAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~PERMITIL~SCHERING~5MG/ML~N~016008~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
PERPHENAZINE~CONCENTRATE;ORAL~PERPHENAZINE~PHARM ASSOC~16MG/5ML~A~040360~001~~Ma
y 25, 2001~No~DISCN~PHARMACEUTICAL ASSOC INC
PROCHLORPERAZINE EDISYLATE~CONCENTRATE;ORAL~PROCHLORPERAZINE~ALPHARMA US PHARMS~
EQ 10MG BASE/ML~A~087153~001~~Jun 8, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS D
IVISION
PROCHLORPERAZINE EDISYLATE~CONCENTRATE;ORAL~PROCHLORPERAZINE EDISYLATE~MORTON GR
OVE~EQ 10MG BASE/ML~A~088598~001~~Oct 25, 1984~No~DISCN~MORTON GROVE PHARMACEUTI
CALS INC
CARPHENAZINE MALEATE~CONCENTRATE;ORAL~PROKETAZINE~WYETH AYERST~50MG/ML~N~014173~
FLUPHENAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~PROLIXIN~APOTHECON~5MG/ML~A~070533~0
01~~Nov 7, 1985~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
PROPRANOLOL HYDROCHLORIDE~CONCENTRATE;ORAL~PROPRANOLOL HYDROCHLORIDE INTENSOL~RO
XANE~80MG/ML~A~071388~001~~May 15, 1987~No~DISCN~ROXANE LABORATORIES INC
MESORIDAZINE BESYLATE~CONCENTRATE;ORAL~SERENTIL~NOVARTIS~EQ 25MG BASE/ML~N~01699
7~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
SERTRALINE HYDROCHLORIDE~CONCENTRATE;ORAL~SERTRALINE HYDROCHLORIDE~AUROBINDO PHA
RMA~EQ 20MG BASE/ML~A~078861~001~AA~Oct 31, 2008~No~RX~AUROBINDO PHARMA LTD
SERTRALINE HYDROCHLORIDE~CONCENTRATE;ORAL~SERTRALINE HYDROCHLORIDE~RANBAXY LABS
LTD~EQ 20MG BASE/ML~A~078053~001~~Feb 5, 2007~No~DISCN~RANBAXY LABORATORIES LTD
SERTRALINE HYDROCHLORIDE~CONCENTRATE;ORAL~SERTRALINE HYDROCHLORIDE~ROXANE~EQ 20M
G BASE/ML~A~076934~001~~Jun 30, 2006~No~DISCN~ROXANE LABORATORIES INC
DOXEPIN HYDROCHLORIDE~CONCENTRATE;ORAL~SINEQUAN~PFIZER~EQ 10MG BASE/ML~N~017516~
001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~SONAZINE~SANDOZ~30MG/ML~A~080983~0
04~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~SONAZINE~SANDOZ~100MG/ML~A~080983~
PROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~SPARINE~WYETH AYERST~30MG/ML~N~010942~0
PROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~SPARINE~WYETH AYERST~100MG/ML~N~010942~
TRIFLUOPERAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~STELAZINE~GLAXOSMITHKLINE~EQ 10MG
BASE/ML~N~011552~006~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CHLORPROTHIXENE~CONCENTRATE;ORAL~TARACTAN~ROCHE~100MG/5ML~N~016149~002~~Approved
Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~ACTAVIS M
ID ATLANTIC~100MG/ML~A~088229~001~~Aug 23, 1983~No~DISCN~ACTAVIS MID ATLANTIC LL
C
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~ALPHARMA
US PHARMS~30MG/ML~A~087766~001~~Apr 26, 1983~No~DISCN~ALPHARMA US PHARMACEUTICAL
S DIVISION
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~ANI PHARM
S INC~100MG/ML~A~089603~001~~Nov 9, 1987~No~DISCN~ANI PHARMACEUTICALS INC
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~HI TECH P
HARMA~30MG/ML~A~040125~001~~Aug 16, 1996~No~DISCN~HI TECH PHARMACAL CO INC
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~HI TECH P
HARMA~100MG/ML~A~040126~001~~Aug 16, 1996~No~DISCN~HI TECH PHARMACAL CO INC
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~PHARM ASS

OC~30MG/ML~A~040187~001~~Aug 28, 1997~No~DISCN~PHARMACEUTICAL ASSOC INC DIV BEAC
H PRODUCTS
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~PHARM ASS
OC~100MG/ML~A~040213~001~~May 29, 1998~No~DISCN~PHARMACEUTICAL ASSOC INC DIV BEA
CH PRODUCTS
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~SANDOZ~30
MG/ML~A~088307~001~~Nov 23, 1983~No~DISCN~SANDOZ INC
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~SANDOZ~10
0MG/ML~A~088308~001~~Nov 23, 1983~No~DISCN~SANDOZ INC
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~TEVA PHAR
MS~30MG/ML~A~089602~001~~Nov 9, 1987~No~DISCN~TEVA PHARMACEUTICALS USA
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~WOCKHARDT
~30MG/ML~A~088258~001~~Jul 25, 1983~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE~WOCKHARDT
~100MG/ML~A~088227~001~~Jul 5, 1983~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE INTENSOL~
ROXANE~30MG/ML~A~088941~001~~Dec 16, 1985~No~DISCN~ROXANE LABORATORIES INC
THIORIDAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THIORIDAZINE HYDROCHLORIDE INTENSOL~
ROXANE~100MG/ML~A~088942~001~~Dec 16, 1985~No~DISCN~ROXANE LABORATORIES INC
THIOTHIXENE HYDROCHLORIDE~CONCENTRATE;ORAL~THIOTHIXENE HYDROCHLORIDE~ALPHARMA US
PHARMS~EQ 5MG BASE/ML~A~070969~001~~Oct 16, 1987~No~DISCN~ALPHARMA US PHARMACEU
TICALS DIVISION
THIOTHIXENE HYDROCHLORIDE~CONCENTRATE;ORAL~THIOTHIXENE HYDROCHLORIDE~PACO~EQ 1MG
BASE/ML~A~071917~001~~Sep 20, 1989~No~DISCN~PACO RESEARCH CORP
THIOTHIXENE HYDROCHLORIDE~CONCENTRATE;ORAL~THIOTHIXENE HYDROCHLORIDE~PACO~EQ 5MG
BASE/ML~A~071939~001~~Dec 16, 1988~No~DISCN~PACO RESEARCH CORP
THIOTHIXENE HYDROCHLORIDE~CONCENTRATE;ORAL~THIOTHIXENE HYDROCHLORIDE~TEVA~EQ 5MG
BASE/ML~A~071184~001~~Jun 22, 1987~No~DISCN~TEVA PHARMACEUTICALS USA INC
THIOTHIXENE HYDROCHLORIDE~CONCENTRATE;ORAL~THIOTHIXENE HYDROCHLORIDE~TEVA PHARMS
~EQ 5MG BASE/ML~A~071554~001~~Oct 16, 1987~No~DISCN~TEVA PHARMACEUTICALS USA
THIOTHIXENE HYDROCHLORIDE~CONCENTRATE;ORAL~THIOTHIXENE HYDROCHLORIDE INTENSOL~CY
CLE PHARMS LTD~EQ 5MG BASE/ML~A~073494~001~~Jun 30, 1992~No~DISCN~CYCLE PHARMACE
UTICALS LTD
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THORAZINE~GLAXOSMITHKLINE~30MG/ML
**Federal Register determination that product was not discontinued or withdrawn
for safety or efficacy reasons**~N~009149~032~~Approved Prior to Jan 1, 1982~No~
DISCN~GLAXOSMITHKLINE
CHLORPROMAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~THORAZINE~GLAXOSMITHKLINE~100MG/ML
for safety or efficacy reasons**~N~009149~043~~Approved Prior to Jan 1, 1982~No
~DISCN~GLAXOSMITHKLINE
TRIFLUOPERAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~TRIFLUOPERAZINE HYDROCHLORIDE~SAN
DOZ~EQ 10MG BASE/ML~A~085787~001~~Apr 15, 1982~No~DISCN~SANDOZ INC
TRIFLUOPERAZINE HYDROCHLORIDE~CONCENTRATE;ORAL~TRIFLUOPERAZINE HYDROCHLORIDE~WOC
KHARDT~EQ 10MG BASE/ML~A~088143~001~~Jul 26, 1983~No~DISCN~WOCKHARDT EU OPERATIO
NS (SWISS) AG
PERPHENAZINE~CONCENTRATE;ORAL~TRILAFON~SCHERING~16MG/5ML~N~011557~001~~Approved
Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
SERTRALINE HYDROCHLORIDE~CONCENTRATE;ORAL~ZOLOFT~PFIZER~EQ 20MG BASE/ML~N~020990
~001~AA~Dec 7, 1999~Yes~RX~PFIZER PHARMACEUTICALS INC
BETAMETHASONE DIPROPIONATE~CREAM, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~F
OUGERA PHARMS~EQ 0.05% BASE~A~076215~001~AB~Dec 9, 2003~No~RX~FOUGERA PHARMACEUT
ICALS INC
BETAMETHASONE DIPROPIONATE~CREAM, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~G
LENMARK GENERICS~EQ 0.05% BASE~A~078930~001~AB~Sep 23, 2008~No~RX~GLENMARK GENER
ICS INC USA
BETAMETHASONE DIPROPIONATE~CREAM, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~P
ERRIGO NEW YORK~EQ 0.05% BASE~A~076592~001~AB~Dec 9, 2003~No~RX~PERRIGO NEW YORK
INC
BETAMETHASONE DIPROPIONATE~CREAM, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~T

ARO~EQ 0.05% BASE~A~076543~001~AB~Dec 9, 2003~No~RX~TARO PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~CREAM, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~T
OLMAR~EQ 0.05% BASE~A~076603~001~AB~Jan 23, 2004~No~RX~TOLMAR INC
BETAMETHASONE DIPROPIONATE~CREAM, AUGMENTED;TOPICAL~DIPROLENE~SCHERING~EQ 0.05%
BASE~N~019408~001~~Jan 31, 1986~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
BETAMETHASONE DIPROPIONATE~CREAM, AUGMENTED;TOPICAL~DIPROLENE AF~MERCK SHARP DOH
ME~EQ 0.05% BASE~N~019555~001~AB~Apr 27, 1987~Yes~RX~MERCK SHARP AND DOHME CORP
MICONAZOLE NITRATE~CREAM, SUPPOSITORY;TOPICAL, VAGINAL~M-ZOLE 3 COMBINATION PACK
~ACTAVIS MID ATLANTIC~2%,200MG~A~074926~001~~Apr 16, 1999~No~OTC~ACTAVIS MID ATL
ANTIC LLC
MICONAZOLE NITRATE~CREAM, SUPPOSITORY;TOPICAL, VAGINAL~M-ZOLE 7 DUAL PACK~ACTAVI
S MID ATLANTIC~2%,100MG~A~074586~001~~Jul 17, 1997~No~DISCN~ACTAVIS MID ATLANTIC
LLC
MICONAZOLE NITRATE~CREAM, SUPPOSITORY;TOPICAL, VAGINAL~MICONAZOLE 7 COMBINATION
PACK~G AND W LABS~2%,100MG~A~076585~001~~Mar 26, 2004~No~OTC~G AND W LABORATORIE
S INC
MICONAZOLE NITRATE~CREAM, SUPPOSITORY;TOPICAL, VAGINAL~MICONAZOLE NITRATE~PERRIG
O R AND D~2%,1.2GM~A~079114~001~~Jun 2, 2010~No~OTC~PERRIGO R AND D CO
MICONAZOLE NITRATE~CREAM, SUPPOSITORY;TOPICAL, VAGINAL~MICONAZOLE NITRATE COMBIN
ATION PACK~PERRIGO~2%,200MG~A~075329~001~~Apr 20, 1999~No~OTC~PERRIGO CO
MICONAZOLE NITRATE~CREAM, SUPPOSITORY;TOPICAL, VAGINAL~MONISTAT 1 COMBINATION PA
CK~MEDTECH PRODUCTS~2%,1.2GM~N~021308~001~~Jun 29, 2001~Yes~OTC~MEDTECH PRODUCTS
INC
MICONAZOLE NITRATE~CREAM, SUPPOSITORY;TOPICAL, VAGINAL~MONISTAT 7 COMBINATION PA
CK~MEDTECH PRODUCTS~2%,100MG~N~020288~002~~Apr 26, 1993~Yes~OTC~MEDTECH PRODUCTS
INC
MICONAZOLE NITRATE~CREAM, SUPPOSITORY;TOPICAL, VAGINAL~MONISTAT-3 COMBINATION PA
CK~MEDTECH PRODUCTS~2%,200MG~N~020670~002~~Apr 16, 1996~Yes~OTC~MEDTECH PRODUCTS
INC
CLOTRIMAZOLE~CREAM, TABLET;TOPICAL, VAGINAL~GYNE-LOTRIMIN 3 COMBINATION PACK~BAY
ER HEALTHCARE LLC~1%,200MG~N~020526~002~~Jul 29, 1996~Yes~OTC~BAYER HEALTHCARE L
LC
CLOTRIMAZOLE~CREAM, TABLET;TOPICAL, VAGINAL~GYNE-LOTRIMIN COMBINATION PACK~SCHER
ING PLOUGH~1%,100MG~N~020289~002~~Apr 26, 1993~Yes~OTC~SCHERING PLOUGH HEALTHCAR
E PRODUCTS INC
CLOTRIMAZOLE~CREAM, TABLET;TOPICAL, VAGINAL~MYCELEX-7 COMBINATION PACK~BAYER HEA
LTHCARE LLC~1%,100MG~N~020389~002~~Jun 23, 1994~No~OTC~BAYER HEALTHCARE LLC
DOCOSANOL~CREAM;TOPICAL~ABREVA~GLAXOSMITHKLINE~10%~N~020941~001~~Jul 25, 2000~Ye
s~OTC~GLAXOSMITHKLINE
ALCLOMETASONE DIPROPIONATE~CREAM;TOPICAL~ACLOVATE~FOUGERA PHARMS~0.05%~N~018707~
001~~Dec 14, 1982~No~DISCN~FOUGERA PHARMACEUTICALS INC
MASOPROCOL~CREAM;TOPICAL~ACTINEX~UNIV AZ CANCER CTR~10%~N~019940~001~~Sep 4, 199
2~No~DISCN~UNIV ARIZONA CANCER CENTER
ADAPALENE~CREAM;TOPICAL~ADAPALENE~FOUGERA PHARMS~0.1%~A~090824~001~AB~Jun 30, 20
10~No~RX~FOUGERA PHARMACEUTICALS INC
ACRISORCIN~CREAM;TOPICAL~AKRINOL~SCHERING~2MG/GM~N~012470~001~~Approved Prior to
Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
HYDROCORTISONE~CREAM;TOPICAL~ALA-CORT~CROWN LABS~1%~A~080706~006~AT~Approved Pri
or to Jan 1, 1982~No~RX~CROWN LABORATORIES INC
ALCLOMETASONE DIPROPIONATE~CREAM;TOPICAL~ALCLOMETASONE DIPROPIONATE~FOUGERA PHAR
MS~0.05%~A~076973~001~AB~Jul 12, 2005~Yes~RX~FOUGERA PHARMACEUTICALS INC
ALCLOMETASONE DIPROPIONATE~CREAM;TOPICAL~ALCLOMETASONE DIPROPIONATE~GLENMARK GEN
ERICS~0.05%~A~079061~001~AB~Jun 23, 2009~No~RX~GLENMARK GENERICS LTD
ALCLOMETASONE DIPROPIONATE~CREAM;TOPICAL~ALCLOMETASONE DIPROPIONATE~TARO~0.05%~A
~076587~001~AB~Sep 15, 2005~No~RX~TARO PHARMACEUTICALS USA INC
IMIQUIMOD~CREAM;TOPICAL~ALDARA~MEDICIS~5%~N~020723~001~AB~Feb 27, 1997~Yes~RX~ME
DICIS PHARMACEUTICAL CORP
HYDROCORTISONE; UREA~CREAM;TOPICAL~ALPHADERM~BIOGLAN~1%;10%~A~086008~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~BIOGLAN LABORATORIES LTD
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~ALPHATREX~SAVAGE LABS~EQ 0.05% BASE~N~0

19138~001~~Jun 26, 1984~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
AMCINONIDE~CREAM;TOPICAL~AMCINONIDE~FOUGERA PHARMS~0.1%~A~076065~001~AB~May 15,
2003~Yes~RX~FOUGERA PHARMACEUTICALS INC
AMCINONIDE~CREAM;TOPICAL~AMCINONIDE~TARO PHARM INDS~0.1%~A~076229~001~AB~May 31,
2002~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
AMMONIUM LACTATE~CREAM;TOPICAL~AMMONIUM LACTATE~PERRIGO NEW YORK~EQ 12% BASE~A~0
75774~001~AB~May 1, 2002~No~RX~PERRIGO NEW YORK INC
AMMONIUM LACTATE~CREAM;TOPICAL~AMMONIUM LACTATE~TARO~EQ 12% BASE~A~075883~001~AB
~Apr 10, 2003~No~RX~TARO PHARMACEUTICALS USA INC
AMMONIUM LACTATE~CREAM;TOPICAL~AMMONIUM LACTATE~WATSON LABS INC~EQ 12% BASE~A~07
6829~001~AB~Feb 7, 2006~No~RX~WATSON LABORATORIES INC
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE~CREAM;TOPICAL~ANTHELIOS 20~L
OREAL USA~2%;2%;10%;2%~N~021471~001~~Oct 5, 2006~Yes~OTC~LOREAL USA PRODUCTS INC
OREAL USA~2%;3%;10%;5%~N~022009~001~~Mar 31, 2008~Yes~OTC~LOREAL USA PRODUCTS IN
C
OREAL USA~2%;3%;10%;5%~N~022009~002~~Oct 29, 2009~Yes~OTC~LOREAL USA PRODUCTS IN
C
AVOBENZONE; ECAMSULE; OCTOCRYLENE~CREAM;TOPICAL~ANTHELIOS SX~LOREAL USA~2%;2%;10
%~N~021502~001~~Jul 21, 2006~Yes~OTC~LOREAL USA PRODUCTS INC
HYDROCORTISONE~CREAM;TOPICAL~ANUSOL HC~SALIX PHARMS~2.5%~A~088250~001~AT~Jun 6,
1984~No~RX~SALIX PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT~ASTELLAS~0.025%~A~083017~003~~A
pproved Prior to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT~ASTELLAS~0.1%~A~083016~004~~App
roved Prior to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT~ASTELLAS~0.5%~A~083015~002~~App
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT A~ASTELLAS~0.025%~A~083017~004~
~Approved Prior to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT A~ASTELLAS~0.025%~A~088818~001~
~Oct 16, 1984~No~DISCN~ASTELLAS PHARMA US INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT A~ASTELLAS~0.1%~A~083016~005~~A
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT A~ASTELLAS~0.1%~A~088819~001~~O
ct 16, 1984~No~DISCN~ASTELLAS PHARMA US INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT A~ASTELLAS~0.5%~A~083015~003~~A
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~ARISTOCORT A~ASTELLAS~0.5%~A~088820~001~~O
ct 16, 1984~No~DISCN~ASTELLAS PHARMA US INC
TAZAROTENE~CREAM;TOPICAL~AVAGE~ALLERGAN~0.1%~N~021184~003~~Sep 30, 2002~Yes~RX~A
LLERGAN INC
TRETINOIN~CREAM;TOPICAL~AVITA~MYLAN PHARMS INC~0.025%~N~020404~003~AB~Jan 14, 19
AZELAIC ACID~CREAM;TOPICAL~AZELEX~ALLERGAN~20%~N~020428~001~~Sep 13, 1995~Yes~RX
~ALLERGAN INC
MUPIROCIN CALCIUM~CREAM;TOPICAL~BACTROBAN~GLAXOSMITHKLINE~EQ 2% BASE~N~050746~00
1~AB~Dec 11, 1997~Yes~RX~GLAXOSMITHKLINE
MONOBENZONE~CREAM;TOPICAL~BENOQUIN~VALEANT PHARM INTL~20%~N~008173~003~~Approved
Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
BETAMETHASONE VALERATE~CREAM;TOPICAL~BETA-VAL~TEVA~EQ 0.1% BASE~N~018642~001~AB~
Mar 24, 1983~No~RX~TEVA PHARMACEUTICALS USA INC
BETAMETHASONE VALERATE~CREAM;TOPICAL~BETADERM~ROACO~EQ 0.1% BASE~N~018839~001~~J
un 30, 1983~No~DISCN~TJ ROACO LTD
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~BETAMETHASONE DIPROPIONATE~ACTAVIS MID
ATLANTIC~EQ 0.05% BASE~A~070885~001~AB~Feb 3, 1987~No~RX~ACTAVIS MID ATLANTIC LL
C
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~BETAMETHASONE DIPROPIONATE~FOUGERA PHAR
MS~EQ 0.05% BASE~N~019137~001~AB~Jun 26, 1984~Yes~RX~FOUGERA PHARMACEUTICALS INC

BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~BETAMETHASONE DIPROPIONATE~PERRIGO NEW
YORK~EQ 0.05% BASE~A~072536~001~~Jan 31, 1990~No~DISCN~PERRIGO NEW YORK INC
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~BETAMETHASONE DIPROPIONATE~PERRIGO NEW
YORK~EQ 0.05% BASE~A~074579~001~~Nov 26, 1997~No~DISCN~PERRIGO NEW YORK INC
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~BETAMETHASONE DIPROPIONATE~PHARMADERM~E
Q 0.05% BASE~N~019136~001~~Jun 26, 1984~No~DISCN~PHARMADERM DIV ALTANA INC
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~BETAMETHASONE DIPROPIONATE~TARO~EQ 0.05
% BASE~A~071143~001~~Jun 17, 1987~No~DISCN~TARO PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~BETAMETHASONE DIPROPIONATE~TARO~EQ 0.05
% BASE~A~073552~001~AB~Apr 30, 1992~No~RX~TARO PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~BETAMETHASONE DIPROPIONATE~TEVA~EQ 0.05
% BASE~A~071476~001~~Aug 10, 1987~No~DISCN~TEVA PHARMACEUTICALS USA INC
BETAMETHASONE VALERATE~CREAM;TOPICAL~BETAMETHASONE VALERATE~FOUGERA~EQ 0.1% BASE
~N~018861~001~AB~Aug 31, 1983~Yes~RX~E FOUGERA DIV ALTANA INC
BETAMETHASONE VALERATE~CREAM;TOPICAL~BETAMETHASONE VALERATE~PERRIGO NEW YORK~EQ
0.1% BASE~A~070053~001~~Jun 10, 1986~No~DISCN~PERRIGO NEW YORK INC
BETAMETHASONE VALERATE~CREAM;TOPICAL~BETAMETHASONE VALERATE~PHARMADERM~EQ 0.1% B
ASE~N~018860~002~~Aug 31, 1983~No~DISCN~PHARMADERM DIV ALTANA INC
BETAMETHASONE VALERATE~CREAM;TOPICAL~BETAMETHASONE VALERATE~PHARMAFAIR~EQ 0.1% B
ASE~A~070485~001~~May 29, 1987~No~DISCN~PHARMAFAIR INC
BETAMETHASONE VALERATE~CREAM;TOPICAL~BETAMETHASONE VALERATE~TARO~EQ 0.1% BASE~A~
070062~001~~May 14, 1985~No~DISCN~TARO PHARMACEUTICALS USA INC
BETAMETHASONE VALERATE~CREAM;TOPICAL~BETATREX~SAVAGE LABS~EQ 0.1% BASE~N~018862~
001~~Aug 31, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
CALCIPOTRIENE~CREAM;TOPICAL~CALCIPOTRIENE~TOLMAR~0.005%~A~200935~001~AB~May 30,
2012~No~RX~TOLMAR INC
HYDROCORTISONE; UREA~CREAM;TOPICAL~CALMURID HC~PHARMACIA AND UPJOHN~1%;10%~A~083
NYSTATIN~CREAM;TOPICAL~CANDEX~BAYER PHARMS~100,000 UNITS/GM~A~061810~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
AVOBENZONE; ECAMSULE; OCTOCRYLENE~CREAM;TOPICAL~CAPITAL SOLEIL 15~LOREAL USA~2%;
3%;10%~N~021501~001~~Oct 2, 2006~Yes~OTC~LOREAL USA PRODUCTS INC
FLUOROURACIL~CREAM;TOPICAL~CARAC~VALEANT PHARMS NORTH~0.5%~N~020985~001~~Oct 27,
2000~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
HYDROCORTISONE ACETATE; UREA~CREAM;TOPICAL~CARMOL HC~FOUGERA PHARMS~1%;10%~A~080
505~001~~Approved Prior to Jan 1, 1982~No~DISCN~FOUGERA PHARMACEUTICALS INC
BETAMETHASONE~CREAM;TOPICAL~CELESTONE~SCHERING~0.2%~N~014762~001~~Approved Prior
to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
CHLORAMPHENICOL~CREAM;TOPICAL~CHLOROMYCETIN~PARKE DAVIS~1%~N~050183~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER L
AMBERT CO
CICLOPIROX~CREAM;TOPICAL~CICLOPIROX~FOUGERA PHARMS~0.77%~A~076435~001~AB~Dec 29,
CICLOPIROX~CREAM;TOPICAL~CICLOPIROX~G AND W LABS INC~0.77%~A~078463~001~AB~Dec 2
0, 2010~No~RX~G AND W LABORATORIES INC
CICLOPIROX~CREAM;TOPICAL~CICLOPIROX~GLENMARK PHARMS~0.77%~A~090273~001~AB~Nov 10
, 2009~No~RX~GLENMARK PHARMACEUTICALS INC USA
CICLOPIROX~CREAM;TOPICAL~CICLOPIROX~PERRIGO~0.77%~A~077364~001~AB~Mar 3, 2006~No
~RX~PERRIGO CO
CICLOPIROX~CREAM;TOPICAL~CICLOPIROX~TARO~0.77%~A~076790~001~AB~Apr 12, 2005~No~R
X~TARO PHARMACEUTICALS USA INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CLOBETASOL PROPIONATE~FOUGERA~0.05%~A~074392
~001~AB1~Sep 30, 1996~No~RX~E FOUGERA DIV ALTANA INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CLOBETASOL PROPIONATE~G AND W LABS INC~0.05%
~A~074139~001~AB1~Aug 3, 1994~No~RX~G AND W LABORATORIES INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CLOBETASOL PROPIONATE~RENAISSANCE PHARMA~0.0
5%~A~075338~001~~Feb 9, 2001~No~DISCN~RENAISSANCE PHARMA US HOLDINGS INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CLOBETASOL PROPIONATE~TARO~0.05%~A~074249~00
1~AB1~Jul 8, 1996~No~RX~TARO PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CLOBETASOL PROPIONATE~TEVA PHARMS USA~0.05%~

A~074087~001~~Feb 16, 1994~No~DISCN~TEVA PHARMACEUTICALS USA
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CLOBETASOL PROPIONATE (EMOLLIENT)~FOUGERA PH
ARMS~0.05%~A~075430~001~AB2~May 26, 1999~No~RX~FOUGERA PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CLOBETASOL PROPIONATE (EMOLLIENT)~RENAISSANC
E PHARMA~0.05%~A~075733~001~~Aug 22, 2001~No~DISCN~RENAISSANCE PHARMA US HOLDING
S INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CLOBETASOL PROPIONATE (EMOLLIENT)~TARO~0.05%
~A~075633~001~AB2~May 17, 2000~No~RX~TARO PHARMACEUTICALS USA INC
CLOCORTOLONE PIVALATE~CREAM;TOPICAL~CLODERM~PROMIUS PHARMA LLC~0.1%~N~017765~001
~~Approved Prior to Jan 1, 1982~Yes~RX~PROMIUS PHARMA LLC
CLOTRIMAZOLE~CREAM;TOPICAL~CLOTRIMAZOLE~FOUGERA PHARMS~1%~A~078338~001~AB~Sep 2,
CLOTRIMAZOLE~CREAM;TOPICAL~CLOTRIMAZOLE~GLENMARK PHARMS~1%~A~090219~001~AB~Aug 3
, 2010~No~RX~GLENMARK PHARMACEUTICALS INC USA
CLOTRIMAZOLE~CREAM;TOPICAL~CLOTRIMAZOLE~TARO~1%~A~072640~001~AB~Aug 31, 1993~Yes
~RX~TARO PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE~CREAM;TOPICAL~CLOTRIMAZOLE AND BETAMETH
ASONE DIPROPIONATE~ACTAVIS MID ATLANTIC~EQ 0.05% BASE;1%~A~076002~001~AB~Aug 2,
2002~No~RX~ACTAVIS MID ATLANTIC LLC
ASONE DIPROPIONATE~FOUGERA PHARMS~EQ 0.05% BASE;1%~A~075502~001~AB~Jun 5, 2001~N
o~RX~FOUGERA PHARMACEUTICALS INC
ASONE DIPROPIONATE~TARO~EQ 0.05% BASE;1%~A~075673~001~AB~May 29, 2001~No~RX~TARO
FLURANDRENOLIDE~CREAM;TOPICAL~CORDRAN SP~AQUA PHARMS~0.025%~N~012806~003~~Approv
ed Prior to Jan 1, 1982~Yes~RX~AQUA PHARMACEUTICALS
FLURANDRENOLIDE~CREAM;TOPICAL~CORDRAN SP~AQUA PHARMS~0.05%~N~012806~002~~Approve
d Prior to Jan 1, 1982~Yes~RX~AQUA PHARMACEUTICALS
FLURANDRENOLIDE; NEOMYCIN SULFATE~CREAM;TOPICAL~CORDRAN-N~LILLY~0.05%;EQ 3.5MG B
ASE/GM~N~050346~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
CLOBETASOL PROPIONATE~CREAM;TOPICAL~CORMAX~HI TECH PHARMA~0.05%~A~074220~001~AB1
~May 16, 1997~No~RX~HI TECH PHARMACAL CO INC
HYDROCORTISONE~CREAM;TOPICAL~CORT-DOME~BAYER PHARMS~0.5%~N~009585~003~~Approved
Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
HYDROCORTISONE~CREAM;TOPICAL~CORT-DOME~BAYER PHARMS~1%~N~009585~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~CREAM;TOPICAL~CORT
ISPORIN~MONARCH PHARMS~0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~N~050218~001~~Aug 9
, 1985~Yes~RX~MONARCH PHARMACEUTICALS INC
FLUTICASONE PROPIONATE~CREAM;TOPICAL~CUTIVATE~FOUGERA PHARMS~0.05% **Federal Reg
efficacy reasons**~N~019958~001~~Dec 18, 1990~No~DISCN~FOUGERA PHARMACEUTICALS
INC
AMCINONIDE~CREAM;TOPICAL~CYCLOCORT~ASTELLAS~0.025%~N~018116~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
AMCINONIDE~CREAM;TOPICAL~CYCLOCORT~ASTELLAS~0.1%~N~018116~002~~Approved Prior to
Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
DEXAMETHASONE SODIUM PHOSPHATE~CREAM;TOPICAL~DECADRON~MERCK~EQ 0.1% PHOSPHATE~N~
011983~002~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
PENCICLOVIR SODIUM~CREAM;TOPICAL~DENAVIR~DENCO ASSET~1%~N~020629~001~~Sep 24, 19
96~Yes~RX~DENCO ASSET LLC
BETAMETHASONE VALERATE~CREAM;TOPICAL~DERMABET~TARO~EQ 0.1% BASE~A~072041~001~AB~
Jan 6, 1988~No~RX~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE~CREAM;TOPICAL~DERMACORT~MONARCH PHARMS~1%~A~083011~002~~Approved
Prior to Jan 1, 1982~No~DISCN~MONARCH PHARMACEUTICALS INC
PREDNICARBATE~CREAM;TOPICAL~DERMATOP E EMOLLIENT~VALEANT BERMUDA~0.1%~N~020279~0
01~AB~Oct 29, 1993~Yes~RX~VALEANT INTERNATIONAL BERMUDA
DESONIDE~CREAM;TOPICAL~DESONIDE~PERRIGO NEW YORK~0.05%~N~017010~001~AB~Approved
Prior to Jan 1, 1982~Yes~RX~PERRIGO NEW YORK INC

DESONIDE~CREAM;TOPICAL~DESONIDE~TARO~0.05%~A~073548~001~AB~Jun 30, 1992~No~RX~TA
RO PHARMACEUTICALS USA INC
DESONIDE~CREAM;TOPICAL~DESONIDE~TEVA PHARMS~0.05%~A~074027~001~~Sep 28, 1992~No~
DESONIDE~CREAM;TOPICAL~DESOWEN~GALDERMA LABS LP~0.05%~N~019048~001~AB~Dec 14, 19
84~No~RX~GALDERMA LABORATORIES LP
DESOXIMETASONE~CREAM;TOPICAL~DESOXIMETASONE~FOUGERA PHARMS~0.25%~A~078369~001~AB
~Jun 29, 2010~No~RX~FOUGERA PHARMACEUTICALS INC
DESOXIMETASONE~CREAM;TOPICAL~DESOXIMETASONE~PERRIGO NEW YORK~0.25%~A~076510~001~
AB~Jul 1, 2003~No~RX~PERRIGO NEW YORK INC
ADAPALENE~CREAM;TOPICAL~DIFFERIN~GALDERMA LABS LP~0.1%~N~020748~001~AB~May 26, 2
000~Yes~RX~GALDERMA LABORATORIES LP
DIFLORASONE DIACETATE~CREAM;TOPICAL~DIFLORASONE DIACETATE~FOUGERA PHARMS~0.05%~A
~075187~001~~Mar 30, 1998~No~DISCN~FOUGERA PHARMACEUTICALS INC
DIFLORASONE DIACETATE~CREAM;TOPICAL~DIFLORASONE DIACETATE~FOUGERA PHARMS~0.05%~A
~076263~001~BX~Dec 20, 2002~Yes~RX~FOUGERA PHARMACEUTICALS INC
DIFLORASONE DIACETATE~CREAM;TOPICAL~DIFLORASONE DIACETATE~TARO~0.05%~A~075508~00
1~BX~Apr 24, 2000~Yes~RX~TARO PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~CREAM;TOPICAL~DIPROSONE~SCHERING~EQ 0.05% BASE~N~0175
36~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH
CORP
CALCIPOTRIENE~CREAM;TOPICAL~DOVONEX~LEO PHARMA AS~0.005%~N~020554~001~AB~Jul 22,
1996~Yes~RX~LEO PHARMA AS
ECONAZOLE NITRATE~CREAM;TOPICAL~ECONAZOLE NITRATE~FOUGERA PHARMS~1%~A~076075~001
~AB~Nov 26, 2002~Yes~RX~FOUGERA PHARMACEUTICALS INC
ECONAZOLE NITRATE~CREAM;TOPICAL~ECONAZOLE NITRATE~IGI LABS INC~1%~A~076574~001~A
B~Dec 17, 2004~No~RX~IGI LABORATORIES INC
ECONAZOLE NITRATE~CREAM;TOPICAL~ECONAZOLE NITRATE~PERRIGO NEW YORK~1%~A~076479~0
01~AB~Jun 23, 2004~No~RX~PERRIGO NEW YORK INC
ECONAZOLE NITRATE~CREAM;TOPICAL~ECONAZOLE NITRATE~TARO~1%~A~076005~001~AB~Nov 26
, 2002~No~RX~TARO PHARMACEUTICALS USA INC
FLUOROURACIL~CREAM;TOPICAL~EFUDEX~VALEANT PHARM INTL~5%~N~016831~003~AB~Approved
Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
HYDROCORTISONE~CREAM;TOPICAL~ELDECORT~VALEANT PHARM INTL~1%~A~080459~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
HYDROCORTISONE~CREAM;TOPICAL~ELDECORT~VALEANT PHARM INTL~2.5%~A~084055~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
PIMECROLIMUS~CREAM;TOPICAL~ELIDEL~VALEANT BERMUDA~1%~N~021302~001~~Dec 13, 2001~
Yes~RX~VALEANT INTERNATIONAL BERMUDA
PERMETHRIN~CREAM;TOPICAL~ELIMITE~RENAISSANCE PHARMA~5%~N~019855~001~AB~Aug 25, 1
989~Yes~RX~RENAISSANCE PHARMA US HOLDINGS INC
MOMETASONE FUROATE~CREAM;TOPICAL~ELOCON~MERCK SHARP DOHME~0.1%~N~019625~001~AB~M
ay 6, 1987~Yes~RX~MERCK SHARP AND DOHME CORP
MOMETASONE FUROATE~CREAM;TOPICAL~ELOCON~MERCK SHARP DOHME~0.1%~N~019625~002~AB~A
pr 19, 2013~No~RX~MERCK SHARP AND DOHME CORP
CLOBETASOL PROPIONATE~CREAM;TOPICAL~EMBELINE E~HI TECH PHARMA~0.05%~A~075325~001
~AB2~Dec 24, 1998~No~RX~HI TECH PHARMACAL CO INC
LIDOCAINE; PRILOCAINE~CREAM;TOPICAL~EMLA~ACTAVIS LABS UT INC~2.5%;2.5%~N~019941~
001~AB~Dec 30, 1992~Yes~RX~ACTAVIS LABORATORIES UT INC
SERTACONAZOLE NITRATE~CREAM;TOPICAL~ERTACZO~VALEANT LUXEMBOURG~2%~N~021385~001~~
Dec 10, 2003~Yes~RX~VALEANT PHARMACEUTICALS LUXEMBOURG SARL
CROTAMITON~CREAM;TOPICAL~EURAX~RANBAXY~10%~N~006927~001~~Approved Prior to Jan 1
, 1982~Yes~RX~RANBAXY LABORATORIES INC
SULCONAZOLE NITRATE~CREAM;TOPICAL~EXELDERM~RANBAXY~1%~N~018737~001~~Feb 28, 1989
~Yes~RX~RANBAXY LABORATORIES INC
HYDROCORTISONE~CREAM;TOPICAL~FLEXICORT~WESTWOOD SQUIBB~0.5%~A~087136~003~~Apr 8,
1982~No~DISCN~WESTWOOD SQUIBB PHARMACEUTICALS INC
HYDROCORTISONE~CREAM;TOPICAL~FLEXICORT~WESTWOOD SQUIBB~1%~A~087136~002~~Apr 8, 1
HYDROCORTISONE~CREAM;TOPICAL~FLEXICORT~WESTWOOD SQUIBB~2.5%~A~087136~001~~Apr 8,
DIFLORASONE DIACETATE~CREAM;TOPICAL~FLORONE~PHARMACIA AND UPJOHN~0.05%~N~017741~
001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
DIFLORASONE DIACETATE~CREAM;TOPICAL~FLORONE E~PHARMACIA AND UPJOHN~0.05%~N~01925
9~001~~Aug 28, 1985~No~DISCN~PHARMACIA AND UPJOHN CO
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCET~ALPHARMA US PHARMS~0.025%~A~088360~
001~~Jan 16, 1984~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~ALPHARMA US PHARMS~0
.01%~A~088361~001~~Jan 16, 1984~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~FOUGERA~0.01%~A~0881
70~001~AT~Dec 16, 1982~No~RX~E FOUGERA DIV ALTANA INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~FOUGERA~0.025%~A~088
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~G AND W LABS~0.01%~A
~089526~001~AT~Jul 26, 1988~No~RX~G AND W LABORATORIES INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~G AND W LABS~0.025%~
A~089525~001~AT~Jul 26, 1988~No~RX~G AND W LABORATORIES INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~PERRIGO NEW YORK~0.0
1%~A~086810~001~~Mar 4, 1982~No~DISCN~PERRIGO NEW YORK INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~PERRIGO NEW YORK~0.0
25%~A~086811~001~~Mar 4, 1982~No~DISCN~PERRIGO NEW YORK INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~PHARMADERM~0.01%~A~0
88047~001~~Dec 16, 1982~No~DISCN~PHARMADERM DIV ALTANA INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~PHARMADERM~0.025%~A~
088045~001~~Dec 16, 1982~No~DISCN~PHARMADERM DIV ALTANA INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~PHARMAFAIR~0.01%~A~0
88499~001~~Aug 2, 1984~No~DISCN~PHARMAFAIR INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~PHARMAFAIR~0.025%~A~
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~TARO~0.01%~A~040035~
001~~Oct 31, 1994~No~DISCN~TARO PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~TARO~0.01%~A~087102~
001~~Apr 27, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~TARO~0.025%~A~040042
~001~~Oct 31, 1994~No~DISCN~TARO PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~TARO~0.025%~A~087104
~001~AT~Apr 27, 1982~No~RX~TARO PHARMACEUTICALS USA INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~USL PHARMA~0.01%~A~0
88757~001~~Feb 11, 1985~No~DISCN~USL PHARMA INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOCINOLONE ACETONIDE~USL PHARMA~0.025%~A~
088756~001~~Mar 28, 1985~No~DISCN~USL PHARMA INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~FOUGERA~0.05%~A~073030~001~AB1~Oct 17, 1
994~No~RX~E FOUGERA DIV ALTANA INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~FOUGERA PHARMS INC~0.1%~A~200735~001~AB~
Jul 14, 2014~No~RX~FOUGERA PHARMACEUTICALS INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~G AND W LABS INC~0.05%~A~073085~001~AB1~
Feb 14, 1992~No~RX~G AND W LABORATORIES INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~GLENMARK GENERICS~0.1%~A~091282~001~AB~J
ul 14, 2014~No~RX~GLENMARK GENERICS LTD
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~PERRIGO ISRAEL~0.1%~A~090256~001~AB~Jan
14, 2014~No~RX~PERRIGO ISRAEL PHARMACEUTICALS
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~PERRIGO NEW YORK~0.05%~A~071790~001~~Jul
13, 1988~No~DISCN~PERRIGO NEW YORK INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~TARO~0.05%~A~071500~001~~Jun 10, 1987~No
~DISCN~TARO PHARMACEUTICALS USA INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~TARO~0.05%~N~019117~001~AB1~Jun 26, 1984
~Yes~RX~TARO PHARMACEUTICALS USA INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~TARO~0.1%~A~200734~001~AB~Jul 14, 2014~N
o~RX~TARO PHARMACEUTICALS USA INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE~TEVA~0.05%~A~072488~001~AB1~Feb 6, 1989~
No~RX~TEVA PHARMACEUTICALS USA INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE EMULSIFIED BASE~FOUGERA PHARMS~0.05%~A~0
76586~001~AB2~Jun 23, 2004~No~RX~FOUGERA PHARMACEUTICALS INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE EMULSIFIED BASE~G AND W LABS INC~0.05%~A
~074204~001~~Jun 13, 1995~No~DISCN~G AND W LABORATORIES INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE EMULSIFIED BASE~TARO~0.05%~A~072494~001~
AB2~Jan 19, 1989~Yes~RX~TARO PHARMACEUTICALS USA INC
FLUOCINONIDE~CREAM;TOPICAL~FLUOCINONIDE EMULSIFIED BASE~TEVA~0.05%~A~072490~001~
AB2~Feb 7, 1989~No~RX~TEVA PHARMACEUTICALS USA INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUONID~ALLERGAN HERBERT~0.025%~A~087156~00
2~~Sep 6, 1984~No~DISCN~ALLERGAN HERBERT DIV ALLERGAN INC
FLUOROURACIL~CREAM;TOPICAL~FLUOROPLEX~AQUA PHARMS~1%~N~016988~001~~Approved Prio
r to Jan 1, 1982~Yes~RX~AQUA PHARMACEUTICALS LLC
FLUOROURACIL~CREAM;TOPICAL~FLUOROURACIL~SPEAR PHARMS~5%~A~077524~001~AB~Apr 11,
2008~No~RX~SPEAR PHARMACEUTICALS INC
FLUOROURACIL~CREAM;TOPICAL~FLUOROURACIL~TARO~5%~A~090368~001~AB~Mar 5, 2010~No~R
X~TARO PHARMACEUTICAL INDUSTRIES LTD
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOTREX~SAVAGE LABS~0.01%~A~088174~001~~Ma
y 6, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~FLUOTREX~SAVAGE LABS~0.025%~A~088173~001~~M
ar 9, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~FLUTEX~IVAX PHARMS~0.025%~A~085539~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~FLUTEX~IVAX PHARMS~0.1%~A~085539~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~FLUTEX~IVAX PHARMS~0.5%~A~085539~003~~Appr
oved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
FLUTICASONE PROPIONATE~CREAM;TOPICAL~FLUTICASONE PROPIONATE~FOUGERA PHARMS~0.05%
~A~076451~001~AB~May 14, 2004~No~RX~FOUGERA PHARMACEUTICALS INC
FLUTICASONE PROPIONATE~CREAM;TOPICAL~FLUTICASONE PROPIONATE~G AND W LABS~0.05%~A
~077055~001~AB~Jun 30, 2006~No~RX~G AND W LABORATORIES INC
FLUTICASONE PROPIONATE~CREAM;TOPICAL~FLUTICASONE PROPIONATE~NESHER PHARMS~0.05%~
A~076865~001~~Sep 10, 2004~No~DISCN~NESHER PHARMACEUTICALS USA LLC
FLUTICASONE PROPIONATE~CREAM;TOPICAL~FLUTICASONE PROPIONATE~PERRIGO NEW YORK~0.0
5%~A~076793~001~AB~May 14, 2004~No~RX~PERRIGO NEW YORK INC
FLUTICASONE PROPIONATE~CREAM;TOPICAL~FLUTICASONE PROPIONATE~TOLMAR~0.05%~A~07663
3~001~AB~May 14, 2004~No~RX~TOLMAR INC
AMPHOTERICIN B~CREAM;TOPICAL~FUNGIZONE~APOTHECON~3%~N~050314~001~~Approved Prior
to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
NITROFURAZONE~CREAM;TOPICAL~FURACIN~SHIRE~0.2%~A~083789~001~~Approved Prior to J
an 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
GENTAMICIN SULFATE~CREAM;TOPICAL~GARAMYCIN~SCHERING~EQ 0.1% BASE~A~060462~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
GENTAMICIN SULFATE~CREAM;TOPICAL~GENTAFAIR~PHARMAFAIR~EQ 0.1% BASE~A~062458~001~
~Sep 1, 1983~No~DISCN~PHARMAFAIR INC
GENTAMICIN SULFATE~CREAM;TOPICAL~GENTAMICIN SULFATE~ALPHARMA US PHARMS~EQ 0.1% B
ASE~A~062471~001~~Sep 27, 1983~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
GENTAMICIN SULFATE~CREAM;TOPICAL~GENTAMICIN SULFATE~FOUGERA~EQ 0.1% BASE~A~06253
1~001~AT~Jul 5, 1984~Yes~RX~E FOUGERA DIV ALTANA INC
GENTAMICIN SULFATE~CREAM;TOPICAL~GENTAMICIN SULFATE~G AND W LABS INC~EQ 0.1% BAS
E~A~064056~001~~Apr 29, 1994~No~DISCN~G AND W LABORATORIES INC
GENTAMICIN SULFATE~CREAM;TOPICAL~GENTAMICIN SULFATE~PERRIGO NEW YORK~EQ 0.1% BAS
E~A~062307~001~AT~Approved Prior to Jan 1, 1982~No~RX~PERRIGO NEW YORK INC
GENTAMICIN SULFATE~CREAM;TOPICAL~GENTAMICIN SULFATE~PHARMADERM~EQ 1MG BASE/GM~A~
062530~001~~Jul 5, 1984~No~DISCN~PHARMADERM DIV ALTANA INC
GENTAMICIN SULFATE~CREAM;TOPICAL~GENTAMICIN SULFATE~TARO~EQ 0.1% BASE~A~062427~0
01~AT~May 26, 1983~No~RX~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE~CREAM;TOPICAL~H-CORT~PHARM ASSOC~0.5%~A~086823~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
HALOBETASOL PROPIONATE~CREAM;TOPICAL~HALOBETASOL PROPIONATE~FOUGERA PHARMS~0.05%

~A~077001~001~AB~Dec 16, 2004~No~RX~FOUGERA PHARMACEUTICALS INC
HALOBETASOL PROPIONATE~CREAM;TOPICAL~HALOBETASOL PROPIONATE~G AND W LABS~0.05%~A
~078162~001~AB~Apr 24, 2007~No~RX~G AND W LABORATORIES INC
HALOBETASOL PROPIONATE~CREAM;TOPICAL~HALOBETASOL PROPIONATE~PERRIGO ISRAEL~0.05%
~A~077123~001~AB~Dec 16, 2004~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
HALOBETASOL PROPIONATE~CREAM;TOPICAL~HALOBETASOL PROPIONATE~TARO~0.05%~A~077227~
001~AB~Aug 4, 2005~No~RX~TARO PHARMACEUTICALS USA INC
HALCINONIDE~CREAM;TOPICAL~HALOG~RANBAXY~0.1%~N~017556~001~~Approved Prior to Jan
1, 1982~Yes~RX~RANBAXY LABORATORIES INC
HALCINONIDE~CREAM;TOPICAL~HALOG~WESTWOOD SQUIBB~0.025%~N~017818~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~WESTWOOD SQUIBB PHARMACEUTICALS INC
HALCINONIDE~CREAM;TOPICAL~HALOG-E~RANBAXY~0.1%~N~018234~001~~Approved Prior to J
an 1, 1982~No~DISCN~RANBAXY LABORATORIES INC
HALOPROGIN~CREAM;TOPICAL~HALOTEX~WESTWOOD SQUIBB~1%~N~016942~001~~Approved Prior
to Jan 1, 1982~No~DISCN~WESTWOOD SQUIBB PHARMACEUTICALS INC
HYDROCORTISONE~CREAM;TOPICAL~HC #1~BAYER PHARMS~0.5%~A~080438~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
HYDROCORTISONE~CREAM;TOPICAL~HC #4~BAYER PHARMS~1%~A~080438~002~~Approved Prior
to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
HYDROCORTISONE~CREAM;TOPICAL~HC (HYDROCORTISONE)~C AND M PHARMA~0.5%~A~080482~00
3~~Approved Prior to Jan 1, 1982~No~DISCN~C AND M PHARMACAL INC
HYDROCORTISONE~CREAM;TOPICAL~HC (HYDROCORTISONE)~C AND M PHARMA~1%~A~080482~004~
~Approved Prior to Jan 1, 1982~No~DISCN~C AND M PHARMACAL INC
HYDROCORTISONE ACETATE~CREAM;TOPICAL~HEMSOL-HC~ABLE~1%~A~081274~001~~Jun 19, 199
2~No~DISCN~ABLE LABORATORIES INC
HYDROCORTISONE~CREAM;TOPICAL~HI-COR~C AND M PHARMA~2.5%~A~080483~001~~Approved P
rior to Jan 1, 1982~No~DISCN~C AND M PHARMACAL INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~ACTAVIS MID ATLANTIC~1%~A~087795~001
~AT~May 3, 1983~No~RX~ACTAVIS MID ATLANTIC LLC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~ACTAVIS MID ATLANTIC~2.5%~A~089682~0
01~AT~Mar 10, 1988~No~RX~ACTAVIS MID ATLANTIC LLC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~ALPHARMA US PHARMS~2.5%~A~089754~001
~~Feb 1, 1989~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~ALTANA~0.5%~A~080848~002~~Approved P
rior to Jan 1, 1982~No~DISCN~ALTANA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~ALTANA~1%~A~080848~003~~Approved Pri
or to Jan 1, 1982~No~DISCN~ALTANA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~AMBIX~1%~A~086080~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~AMBIX LABORATORIES DIV ORGANICS CORP AMERICA
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~AMBIX~2.5%~A~086271~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~AMBIX LABORATORIES DIV ORGANICS CORP AMERICA
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~EVERYLIFE~0.5%~A~080452~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~EVERYLIFE~1%~A~080452~002~~Approved
Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~FOUGERA~1%~A~080693~003~AT~Approved
Prior to Jan 1, 1982~Yes~RX~E FOUGERA DIV ALTANA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~FOUGERA~2.5%~A~089414~001~AT~Dec 16,
1986~Yes~RX~E FOUGERA DIV ALTANA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~G AND W LABS~1%~A~084059~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~G AND W LABORATORIES INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~INGRAM PHARM~0.5%~A~080456~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~INGRAM PHARMACEUTICAL CO
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~INGRAM PHARM~1%~A~080456~003~~Approv
ed Prior to Jan 1, 1982~No~DISCN~INGRAM PHARMACEUTICAL CO
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~IVAX PHARMS~1%~A~085733~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~LYNE~2.5%~A~040879~001~AT~Aug 20, 20
10~No~RX~LYNE LABORATORIES INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~NASKA~1%~A~089706~001~~Mar 10, 1988~

No~DISCN~NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~PERRIGO NEW YORK~0.5%~A~084970~002~~
Approved Prior to Jan 1, 1982~No~DISCN~PERRIGO NEW YORK INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~PERRIGO NEW YORK~1%~A~085026~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PERRIGO NEW YORK INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~PERRIGO NEW YORK~2.5%~A~085025~001~A
T~Approved Prior to Jan 1, 1982~No~RX~PERRIGO NEW YORK INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~PHARMADERM~1%~A~088845~001~~Feb 27,
1986~No~DISCN~PHARMADERM DIV ALTANA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~PHARMADERM~2.5%~A~089413~001~~Dec 16
, 1986~No~DISCN~PHARMADERM DIV ALTANA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~PHARMAFAIR~1%~A~087838~001~~Jul 28,
1982~No~DISCN~PHARMAFAIR INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~STIEFEL~1%~A~086170~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~STIEFEL LABORATORIES INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~SYOSSET~0.5%~A~085527~001~~Approved
Prior to Jan 1, 1982~No~DISCN~SYOSSET LABORATORIES INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~TARO~0.5%~A~086154~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~TARO~1%~A~086155~001~~Approved Prior
to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~TARO~2.5%~A~088799~001~AT~Nov 9, 198
4~No~RX~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~TEVA~0.5%~A~080400~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~TEVA~1%~A~080400~003~~Approved Prior
to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~TEVA~1%~A~085191~001~~Approved Prior
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~TEVA~2.5%~A~080400~004~~Approved Pri
or to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~TOPIDERM~1%~A~089273~001~~Feb 17, 19
89~No~DISCN~TOPIDERM INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~USL PHARMA~1%~A~088027~001~~Sep 27,
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~USL PHARMA~2.5%~A~088029~001~~Sep 27
, 1983~No~DISCN~USL PHARMA INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~VINTAGE PHARMS~2.5%~A~040503~001~AT~
Mar 12, 2004~No~RX~VINTAGE PHARMACEUTICALS INC
HYDROCORTISONE~CREAM;TOPICAL~HYDROCORTISONE~WHITEWORTH TOWN PLSN~1%~A~080496~002
~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
HYDROCORTISONE ACETATE~CREAM;TOPICAL~HYDROCORTISONE ACETATE~CENCI~1%~A~080419~00
1~~Jan 25, 1982~No~DISCN~HR CENCI LABORATORIES INC
HYDROCORTISONE ACETATE~CREAM;TOPICAL~HYDROCORTISONE ACETATE~FERNDALE LABS~2.5%~A
~040259~001~~Jul 29, 1999~Yes~RX~FERNDALE LABORATORIES INC
HYDROCORTISONE ACETATE~CREAM;TOPICAL~HYDROCORTISONE ACETATE~PARKE DAVIS~1%~A~089
914~001~~Jan 3, 1989~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
HYDROCORTISONE ACETATE~CREAM;TOPICAL~HYDROCORTISONE ACETATE~PUREPAC PHARM~0.5%~A
~086050~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
HYDROCORTISONE ACETATE~CREAM;TOPICAL~HYDROCORTISONE ACETATE~PUREPAC PHARM~1%~A~0
HYDROCORTISONE BUTYRATE~CREAM;TOPICAL~HYDROCORTISONE BUTYRATE~GLENMARK GENERICS~
0.1%~A~202145~001~AB2~Sep 27, 2013~No~RX~GLENMARK GENERICS LTD
HYDROCORTISONE BUTYRATE~CREAM;TOPICAL~HYDROCORTISONE BUTYRATE~TARO PHARM INDS~0.
1%~A~076654~001~AB1~Aug 3, 2005~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
HYDROCORTISONE VALERATE~CREAM;TOPICAL~HYDROCORTISONE VALERATE~PERRIGO NEW YORK~0
.2%~A~075666~001~AB~May 24, 2000~No~RX~PERRIGO NEW YORK INC
HYDROCORTISONE VALERATE~CREAM;TOPICAL~HYDROCORTISONE VALERATE~TARO~0.2%~A~075042
~001~AB~Aug 25, 1998~Yes~RX~TARO PHARMACEUTICALS, INC.
HYDROCORTISONE VALERATE~CREAM;TOPICAL~HYDROCORTISONE VALERATE~TEVA PHARMS~0.2%~A

~074489~001~~Aug 12, 1998~No~DISCN~TEVA PHARMACEUTICALS USA
HYDROCORTISONE~CREAM;TOPICAL~HYTONE~VALEANT INTL~1%~A~080472~003~~Approved Prior
to Jan 1, 1982~No~DISCN~VALEANT INTERNATIONAL BARBADOS SRL
HYDROCORTISONE~CREAM;TOPICAL~HYTONE~VALEANT INTL~2.5%~A~080472~004~~Approved Pri
or to Jan 1, 1982~No~DISCN~VALEANT INTERNATIONAL BARBADOS SRL
IMIQUIMOD~CREAM;TOPICAL~IMIQUIMOD~APOTEX INC~5%~A~091308~001~AB~Apr 6, 2012~No~R
X~APOTEX INC
IMIQUIMOD~CREAM;TOPICAL~IMIQUIMOD~FOUGERA PHARMS~5%~A~078548~001~AB~Feb 25, 2010
~No~RX~FOUGERA PHARMACEUTICALS INC
IMIQUIMOD~CREAM;TOPICAL~IMIQUIMOD~GLENMARK GENERICS~5%~A~201994~001~AB~Mar 6, 20
12~No~RX~GLENMARK GENERICS INC USA
IMIQUIMOD~CREAM;TOPICAL~IMIQUIMOD~PERRIGO ISRAEL~5%~A~078837~001~AB~Sep 7, 2010~
No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
IMIQUIMOD~CREAM;TOPICAL~IMIQUIMOD~STRIDES PHARMA~5%~A~202002~001~AB~Jun 24, 2014
~No~RX~STRIDES PHARMA GLOBAL PTE LTD
IMIQUIMOD~CREAM;TOPICAL~IMIQUIMOD~TARO~5%~A~200173~001~AB~Apr 15, 2011~No~RX~TAR
IMIQUIMOD~CREAM;TOPICAL~IMIQUIMOD~TEVA PHARMS USA~5%~A~200481~001~AB~Apr 18, 201
IMIQUIMOD~CREAM;TOPICAL~IMIQUIMOD~TOLMAR~5%~A~091044~001~AB~Feb 28, 2011~No~RX~T
OLMAR INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~KENALOG~DELCOR ASSET CORP~0.025%~N~011601~
003~~Approved Prior to Jan 1, 1982~No~DISCN~DELCOR ASSET CORP
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~KENALOG~DELCOR ASSET CORP~0.1%~N~011601~00
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~KENALOG~DELCOR ASSET CORP~0.5%~A~083943~00
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~KENALOG-H~DELCOR ASSET CORP~0.1%~A~086240~
KETOCONAZOLE~CREAM;TOPICAL~KETOCONAZOLE~FOUGERA PHARMS~2%~A~076294~001~AB~Apr 28
, 2004~No~RX~FOUGERA PHARMACEUTICALS INC
KETOCONAZOLE~CREAM;TOPICAL~KETOCONAZOLE~TEVA~2%~A~075581~001~AB~Apr 25, 2000~Yes
KETOCONAZOLE~CREAM;TOPICAL~KETOZOLE~TARO~2%~A~075638~001~AB~Dec 18, 2002~No~RX~T
ARO PHARMACEUTICALS USA INC
LINDANE~CREAM;TOPICAL~KWELL~REED AND CARNRICK~1%~A~084218~001~~Approved Prior to
Jan 1, 1982~No~DISCN~REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
LINDANE~CREAM;TOPICAL~KWELL~REED AND CARNRICK~1%~N~006309~001~~Approved Prior to
Jan 1, 1982~No~DISCN~REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
AMMONIUM LACTATE~CREAM;TOPICAL~LAC-HYDRIN~RANBAXY~EQ 12% BASE~N~020508~001~AB~Au
g 29, 1996~Yes~RX~RANBAXY LABORATORIES INC
TERBINAFINE HYDROCHLORIDE~CREAM;TOPICAL~LAMISIL~NOVARTIS~1%~N~020192~001~~Dec 30
, 1992~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
TERBINAFINE HYDROCHLORIDE~CREAM;TOPICAL~LAMISIL~NOVARTIS~1%~N~020980~001~~Mar 9,
1999~Yes~OTC~NOVARTIS CONSUMER HEALTH INC
FLUOCINONIDE~CREAM;TOPICAL~LIDEX~CNTY LINE PHARMS~0.05%~N~016908~002~~Approved P
rior to Jan 1, 1982~No~DISCN~COUNTY LINE PHARMACEUTICALS LLC
FLUOCINONIDE~CREAM;TOPICAL~LIDEX-E~CNTY LINE PHARMS~0.05%~N~016908~003~~Approved
Prior to Jan 1, 1982~No~DISCN~COUNTY LINE PHARMACEUTICALS LLC
LIDOCAINE; PRILOCAINE~CREAM;TOPICAL~LIDOCAINE AND PRILOCAINE~FOUGERA PHARMS~2.5%
;2.5%~A~076453~001~AB~Aug 18, 2003~No~RX~FOUGERA PHARMACEUTICALS INC
LIDOCAINE; PRILOCAINE~CREAM;TOPICAL~LIDOCAINE AND PRILOCAINE~HI TECH PHARMA~2.5%
;2.5%~A~076290~001~AB~Sep 25, 2003~No~RX~HI TECH PHARMACAL CO INC
LIDOCAINE; PRILOCAINE~CREAM;TOPICAL~LIDOCAINE AND PRILOCAINE~TOLMAR~2.5%;2.5%~A~
076320~001~AB~Aug 27, 2003~No~RX~TOLMAR INC
HYDROCORTISONE BUTYRATE~CREAM;TOPICAL~LOCOID~PRECISION DERMAT~0.1%~N~018514~001~
AB1~Mar 31, 1982~Yes~RX~PRECISION DERMATOLOGY INC
HYDROCORTISONE BUTYRATE~CREAM;TOPICAL~LOCOID~YAMANOUCHI~0.1%~N~018795~001~~Jan 7
, 1983~No~DISCN~YAMANOUCHI EUROPE BV
HYDROCORTISONE BUTYRATE~CREAM;TOPICAL~LOCOID LIPOCREAM~PRECISION DERMAT~0.1%~N~0

20769~001~AB2~Sep 8, 1997~Yes~RX~PRECISION DERMATOLOGY INC
FLUMETHASONE PIVALATE~CREAM;TOPICAL~LOCORTEN~NOVARTIS~0.03%~N~016379~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
CICLOPIROX~CREAM;TOPICAL~LOPROX~MEDIMETRIKS PHARMS~0.77%~N~018748~001~AB~Dec 30,
1982~Yes~RX~MEDIMETRIKS PHARMACEUTICALS INC
CLOTRIMAZOLE~CREAM;TOPICAL~LOTRIMIN~SCHERING PLOUGH~1%~N~017619~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
BUTENAFINE HYDROCHLORIDE~CREAM;TOPICAL~LOTRIMIN ULTRA~SCHERING PLOUGH~1%~N~02130
7~001~~Dec 7, 2001~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE~CREAM;TOPICAL~LOTRISONE~MERCK SHARP DOH
ME~EQ 0.05% BASE;1%~N~018827~001~AB~Jul 10, 1984~Yes~RX~MERCK SHARP AND DOHME CO
RP
LULICONAZOLE~CREAM;TOPICAL~LUZU~MEDICIS~1%~N~204153~001~~Nov 14, 2013~Yes~RX~MED
ICIS PHARMACEUTICAL CORP
MECLOCYCLINE SULFOSALICYLATE~CREAM;TOPICAL~MECLAN~JOHNSON AND JOHNSON~1%~N~05051
8~001~~Approved Prior to Jan 1, 1982~No~DISCN~JOHNSON AND JOHNSON CONSUMER COMPA
NIES INC
BUTENAFINE HYDROCHLORIDE~CREAM;TOPICAL~MENTAX~MYLAN~1%~N~020524~001~~Oct 18, 199
6~Yes~RX~MYLAN PHARMACEUTICALS INC
BUTENAFINE HYDROCHLORIDE~CREAM;TOPICAL~MENTAX-TC~MYLAN~1%~N~021408~001~~Oct 17,
2002~No~DISCN~MYLAN PHARMACEUTICALS INC
PREDNISOLONE~CREAM;TOPICAL~METI-DERM~SCHERING~0.5%~N~010209~002~~Approved Prior
METRONIDAZOLE~CREAM;TOPICAL~METROCREAM~GALDERMA LABS LP~0.75%~N~020531~001~AB~Se
p 20, 1995~Yes~RX~GALDERMA LABORATORIES LP
METRONIDAZOLE~CREAM;TOPICAL~METRONIDAZOLE~FOUGERA PHARMS~0.75%~A~076408~001~AB~M
ay 28, 2004~No~RX~FOUGERA PHARMACEUTICALS INC
METRONIDAZOLE~CREAM;TOPICAL~METRONIDAZOLE~G AND W LABS~0.75%~A~077549~001~AB~Dec
19, 2007~No~RX~G AND W LABORATORIES INC
METHYL AMINOLEVULINATE HYDROCHLORIDE~CREAM;TOPICAL~METVIXIA~GALDERMA LABS LP~EQ
16.8% BASE~N~021415~001~~Jul 27, 2004~No~DISCN~GALDERMA LABORATORIES LP
HYDROCORTISONE ACETATE~CREAM;TOPICAL~MICORT-HC~SEBELA IRELAND LTD~2%~A~040398~00
1~~Mar 29, 2002~No~RX~SEBELA IRELAND LTD
HYDROCORTISONE ACETATE~CREAM;TOPICAL~MICORT-HC~SEBELA IRELAND LTD~2.5%~A~040396~
001~~Feb 27, 2001~No~RX~SEBELA IRELAND LTD
MOMETASONE FUROATE~CREAM;TOPICAL~MOMETASONE FUROATE~FOUGERA PHARMS~0.1%~A~076171
~001~AB~Apr 8, 2005~No~RX~FOUGERA PHARMACEUTICALS INC
MOMETASONE FUROATE~CREAM;TOPICAL~MOMETASONE FUROATE~G AND W LABS~0.1%~A~077447~0
01~AB~May 22, 2006~No~RX~G AND W LABORATORIES INC
MOMETASONE FUROATE~CREAM;TOPICAL~MOMETASONE FUROATE~GLENMARK GENERICS~0.1%~A~078
541~001~AB~May 28, 2008~No~RX~GLENMARK GENERICS INC USA
MOMETASONE FUROATE~CREAM;TOPICAL~MOMETASONE FUROATE~TARO~0.1%~A~076679~001~AB~De
c 21, 2004~No~RX~TARO PHARMACEUTICALS USA INC
MOMETASONE FUROATE~CREAM;TOPICAL~MOMETASONE FUROATE~TOLMAR~0.1%~A~076591~001~AB~
Apr 18, 2007~No~RX~TOLMAR INC
MICONAZOLE NITRATE~CREAM;TOPICAL~MONISTAT-DERM~INSIGHT PHARMS~2%~N~017494~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~INSIGHT PHARMACEUTICALS CORP
MUPIROCIN CALCIUM~CREAM;TOPICAL~MUPIROCIN~GLENMARK GENERICS~EQ 2% BASE~A~201587~
001~AB~Jan 24, 2013~No~RX~GLENMARK GENERICS INC USA
CLOTRIMAZOLE~CREAM;TOPICAL~MYCELEX~BAYER HEALTHCARE LLC~1%~N~018183~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~BAYER HEALTHCARE LLC
NYSTATIN; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~MYCO-TRIACET II~TEVA~100,000 UNI
TS/GM;0.1%~A~061954~002~~Sep 20, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
NYSTATIN; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~MYCOLOG-II~DELCOR ASSET CORP~100
,000 UNITS/GM;0.1%~A~060576~002~~May 1, 1985~No~DISCN~DELCOR ASSET CORP
NYSTATIN; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~MYCOLOG-II~DELCOR ASSET CORP~100
,000 UNITS/GM;0.1%~A~062606~001~~May 15, 1985~No~DISCN~DELCOR ASSET CORP
NYSTATIN~CREAM;TOPICAL~MYCOSTATIN~DELCOR ASSET CORP~100,000 UNITS/GM~A~060575~00
NYSTATIN; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~MYKACET~G AND W LABS INC~100,000

UNITS/GM;0.1%~A~062367~001~~May 28, 1985~No~DISCN~G AND W LABORATORIES INC
NYSTATIN~CREAM;TOPICAL~MYKINAC~ALPHARMA US PHARMS~100,000 UNITS/GM~A~062387~001~
~Jul 29, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~MYTREX A~SAVAGE LABS~EQ
3.5MG BASE/GM;0.1%~A~062598~001~~Jul 21, 1986~No~DISCN~SAVAGE LABORATORIES INC D
IV ALTANA INC
NYSTATIN; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~MYTREX F~SAVAGE LABS~100,000 UNI
TS/GM;0.1%~A~062597~001~~Oct 8, 1985~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA
INC
NAFTIFINE HYDROCHLORIDE~CREAM;TOPICAL~NAFTIN~MERZ PHARMS~1%~N~019599~001~~Feb 29
, 1988~Yes~RX~MERZ PHARMACEUTICALS LLC
NAFTIFINE HYDROCHLORIDE~CREAM;TOPICAL~NAFTIN~MERZ PHARMS~2%~N~019599~002~~Jan 13
, 2012~Yes~RX~MERZ PHARMACEUTICALS LLC
HYDROCORTISONE; NEOMYCIN SULFATE~CREAM;TOPICAL~NEO-CORT-DOME~BAYER PHARMS~0.5%;E
Q 3.5MG BASE/GM~N~050237~006~~Jun 5, 1984~No~DISCN~BAYER PHARMACEUTICALS CORP
HYDROCORTISONE; NEOMYCIN SULFATE~CREAM;TOPICAL~NEO-CORT-DOME~BAYER PHARMS~1%;EQ
3.5MG BASE/GM~N~050237~005~~Jun 5, 1984~No~DISCN~BAYER PHARMACEUTICALS CORP
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE~CREAM;TOPICAL~NEO-CORTEF~PHARMACIA AND
UPJOHN~1%;EQ 3.5MG BASE/GM~A~061049~001~~Approved Prior to Jan 1, 1982~No~DISCN~
PHARMACIA AND UPJOHN CO
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE~CREAM;TOPICAL~NEO-CORTEF~PHARMACIA AND
UPJOHN~2.5%;EQ 3.5MG BASE/GM~A~061049~002~~Approved Prior to Jan 1, 1982~No~DISC
N~PHARMACIA AND UPJOHN CO
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE~CREAM;TOPICAL~NEO-MEDROL ACETATE~PH
ARMACIA AND UPJOHN~0.25%;EQ 3.5MG BASE/GM~A~060611~002~~Approved Prior to Jan 1,
1982~No~DISCN~PHARMACIA AND UPJOHN CO
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE~CREAM;TOPICAL~NEO-MEDROL ACETATE~PH
ARMACIA AND UPJOHN~1%;EQ 3.5MG BASE/GM~A~060611~001~~Approved Prior to Jan 1, 19
FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE~CREAM;TOPICAL~NEO-SYNALAR~MEDIMETRIKS P
HARMS~0.025%;EQ 3.5MG BASE/GM~A~060700~001~~Approved Prior to Jan 1, 1982~Yes~RX
~MEDIMETRIKS PHARMACEUTICALS INC
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~NEOMYCIN SULFATE-TRIAMCI
NOLONE ACETONIDE~FOUGERA~EQ 3.5MG BASE/GM;0.1%~A~062600~001~~Jul 21, 1986~No~DIS
CN~E FOUGERA DIV ALTANA INC
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~NEOMYCIN SULFATE-TRIAMCI
NOLONE ACETONIDE~PHARMADERM~EQ 3.5MG BASE/GM;0.1%~A~062595~001~~Jul 21, 1986~No~
DISCN~PHARMADERM DIV ALTANA INC
NEOMYCIN SULFATE; POLYMYXIN B SULFATE~CREAM;TOPICAL~NEOSPORIN~GLAXOSMITHKLINE~EQ
3.5MG BASE/GM;10,000 UNITS/GM~N~050176~002~~Jan 14, 1985~No~DISCN~GLAXOSMITHKLI
NE
NYSTATIN~CREAM;TOPICAL~NILSTAT~LEDERLE~100,000 UNITS/GM~A~061445~001~~Approved P
rior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
KETOCONAZOLE~CREAM;TOPICAL~NIZORAL~JANSSEN PHARMA~2%~N~019084~001~~Dec 31, 1985~
No~DISCN~JANSSEN PHARMACEUTICA PRODUCTS LP
HYDROCORTISONE~CREAM;TOPICAL~NOGENIC HC~IVAX PHARMS~1%~A~087427~001~~Apr 4, 1988
~No~DISCN~IVAX PHARMACEUTICALS INC
METRONIDAZOLE~CREAM;TOPICAL~NORITATE~VALEANT PHARMS NORTH~1%~N~020743~001~~Sep 2
6, 1997~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
HYDROCORTISONE~CREAM;TOPICAL~NUTRACORT~DOW PHARM~0.5%~A~080442~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL SCIENCES
HYDROCORTISONE~CREAM;TOPICAL~NUTRACORT~DOW PHARM~1%~A~080442~003~~Approved Prior
to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL SCIENCES
NYSTATIN~CREAM;TOPICAL~NYSTATIN~ACTAVIS MID ATLANTIC~100,000 UNITS/GM~A~062949~0
01~AT~Jun 13, 1988~No~RX~ACTAVIS MID ATLANTIC LLC
NYSTATIN~CREAM;TOPICAL~NYSTATIN~FOUGERA PHARMS~100,000 UNITS/GM~A~062129~001~AT~
Approved Prior to Jan 1, 1982~No~RX~FOUGERA PHARMACEUTICALS INC
NYSTATIN~CREAM;TOPICAL~NYSTATIN~G AND W LABS INC~100,000 UNITS/GM~A~061966~001~~
Approved Prior to Jan 1, 1982~No~DISCN~G AND W LABORATORIES INC
NYSTATIN~CREAM;TOPICAL~NYSTATIN~PERRIGO NEW YORK~100,000 UNITS/GM~A~062225~001~A

T~Approved Prior to Jan 1, 1982~No~RX~PERRIGO NEW YORK INC
NYSTATIN~CREAM;TOPICAL~NYSTATIN~TARO~100,000 UNITS/GM~A~062457~001~~Jul 28, 1983
~No~DISCN~TARO PHARMACEUTICALS USA INC
NYSTATIN~CREAM;TOPICAL~NYSTATIN~TARO~100,000 UNITS/GM~A~064022~001~AT~Jan 29, 19
93~Yes~RX~TARO PHARMACEUTICALS USA INC
NYSTATIN~CREAM;TOPICAL~NYSTATIN~VINTAGE~100,000 UNITS/GM~A~065315~001~AT~May 31,
2006~No~RX~VINTAGE PHARMACEUTICALS LLC
NYSTATIN; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~NYSTATIN AND TRIAMCINOLONE ACETO
NIDE~ALPHARMA US PHARMS~100,000 UNITS/GM;0.1%~A~063010~001~~Dec 20, 1988~No~DISC
N~ALPHARMA US PHARMACEUTICALS DIVISION
NIDE~FOUGERA~100,000 UNITS/GM;0.1%~A~062599~001~AT~Oct 8, 1985~No~RX~E FOUGERA D
IV ALTANA INC
NIDE~PERRIGO NEW YORK~100,000 UNITS/GM;0.1%~A~062186~002~~Jun 6, 1985~No~DISCN~P
ERRIGO NEW YORK INC
NIDE~PHARMAFAIR~100,000 UNITS/GM;0.1%~A~062657~001~~Jul 30, 1986~No~DISCN~PHARMA
FAIR INC
NIDE~TARO~100,000 UNITS/GM;0.1%~A~062347~001~~Mar 30, 1987~No~DISCN~TARO PHARMAC
EUTICALS USA INC
NIDE~TARO~100,000 UNITS/GM;0.1%~A~062364~001~AT~Dec 22, 1987~Yes~RX~TARO PHARMAC
EUTICALS USA INC
NYSTATIN; TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~NYSTATIN-TRIAMCINOLONE ACETONIDE
~PHARMADERM~100,000 UNITS/GM;0.1%~A~062596~001~~Oct 8, 1985~No~DISCN~PHARMADERM
DIV ALTANA INC
OXICONAZOLE NITRATE~CREAM;TOPICAL~OXISTAT~FOUGERA PHARMS~EQ 1% BASE~N~019828~001
~~Dec 30, 1988~Yes~RX~FOUGERA PHARMACEUTICALS INC
FLUOROMETHOLONE~CREAM;TOPICAL~OXYLONE~PHARMACIA AND UPJOHN~0.025%~N~011748~001~~
Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
HYDROCORTISONE PROBUTATE~CREAM;TOPICAL~PANDEL~FOUGERA PHARMS~0.1%~N~020453~001~~
Feb 28, 1997~Yes~RX~FOUGERA PHARMACEUTICALS INC
HYDROCORTISONE~CREAM;TOPICAL~PENECORT~ALLERGAN HERBERT~1%~A~088216~001~~Jun 6, 1
984~No~DISCN~ALLERGAN HERBERT DIV ALLERGAN INC
PERMETHRIN~CREAM;TOPICAL~PERMETHRIN~ACTAVIS MID ATLANTIC~5%~A~074806~001~AB~Jan
23, 1998~No~RX~ACTAVIS MID ATLANTIC LLC
PERMETHRIN~CREAM;TOPICAL~PERMETHRIN~PERRIGO NEW YORK~5%~A~076369~001~AB~Apr 21,
2003~No~RX~PERRIGO NEW YORK INC
LIDOCAINE; TETRACAINE~CREAM;TOPICAL~PLIAGLIS~GALDERMA LABS LP~7%;7%~N~021717~001
~~Jun 29, 2006~Yes~RX~GALDERMA LABORATORIES LP
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE~CREAM;TOPICAL~PRAMOSONE~SEBELA I
RELAND LTD~0.5%;1%~A~083778~001~~Approved Prior to Jan 1, 1982~No~RX~SEBELA IREL
AND LTD
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE~CREAM;TOPICAL~PRAMOSONE~SEBELA I
RELAND LTD~1%;1%~A~085368~001~~Approved Prior to Jan 1, 1982~No~RX~SEBELA IRELAN
D LTD
PREDNICARBATE~CREAM;TOPICAL~PREDNICARBATE~FOUGERA PHARMS~0.1%~A~077287~001~AB~Se
p 19, 2006~No~RX~FOUGERA PHARMACEUTICALS INC
HYDROCORTISONE~CREAM;TOPICAL~PROCTOCORT~MONARCH PHARMS~1%~A~083011~001~~Approved
Prior to Jan 1, 1982~No~DISCN~MONARCH PHARMACEUTICALS INC
DIFLORASONE DIACETATE~CREAM;TOPICAL~PSORCON~TARO PHARMS NORTH~0.05%~N~020205~001
~~Nov 20, 1992~No~DISCN~TARO PHARMACEUTICALS NORTH AMERICA INC
TRETINOIN~CREAM;TOPICAL~RENOVA~VALEANT INTL~0.02%~N~021108~001~~Aug 31, 2000~Yes
~RX~VALEANT INTERNATIONAL BARBADOS SRL
TRETINOIN~CREAM;TOPICAL~RENOVA~VALEANT INTL~0.05%~N~019963~001~AB2~Dec 29, 1995~
Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
TRETINOIN~CREAM;TOPICAL~RETIN-A~VALEANT BERMUDA~0.025%~N~019049~001~AB~Sep 16, 1
988~Yes~RX~VALEANT INTERNATIONAL BERMUDA

TRETINOIN~CREAM;TOPICAL~RETIN-A~VALEANT BERMUDA~0.05%~N~017522~001~AB1~Approved
Prior to Jan 1, 1982~Yes~RX~VALEANT INTERNATIONAL BERMUDA
TRETINOIN~CREAM;TOPICAL~RETIN-A~VALEANT BERMUDA~0.1%~N~017340~001~AB~Approved Pr
ior to Jan 1, 1982~Yes~RX~VALEANT INTERNATIONAL BERMUDA
SILVER SULFADIAZINE~CREAM;TOPICAL~SILVADENE~KING PHARMS~1%~N~017381~001~AB~Appro
ved Prior to Jan 1, 1982~Yes~RX~KING PHARMACEUTICALS INC
IVERMECTIN~CREAM;TOPICAL~SOOLANTRA~GALDERMA LABS LP~1%~N~206255~001~~Dec 19, 201
ECONAZOLE NITRATE~CREAM;TOPICAL~SPECTAZOLE~MERZ PHARMS LLC~1%~N~018751~001~~Dec
23, 1982~No~DISCN~MERZ PHARMACEUTICALS LLC
SILVER SULFADIAZINE~CREAM;TOPICAL~SSD~DR REDDYS LA~1%~N~018578~001~AB~Feb 25, 19
82~No~RX~DR REDDYS LABORATORIES LOUISIANA LLC
SILVER SULFADIAZINE~CREAM;TOPICAL~SSD AF~DR REDDYS LA~1%~N~018578~003~BX~Jul 11,
1990~No~RX~DR REDDYS LABORATORIES LOUISIANA LLC
MAFENIDE ACETATE~CREAM;TOPICAL~SULFAMYLON~MYLAN INSTITUTIONAL~EQ 85MG BASE/GM~N~
016763~001~~Approved Prior to Jan 1, 1982~Yes~RX~MYLAN INSTITUTIONAL INC
HYDROCORTISONE~CREAM;TOPICAL~SYNACORT~MEDICIS~0.5%~A~087459~001~~Approved Prior
to Jan 1, 1982~No~DISCN~MEDICIS PHARMACEUTICAL CORP
HYDROCORTISONE~CREAM;TOPICAL~SYNACORT~MEDICIS~1%~A~087458~001~AT~Approved Prior
to Jan 1, 1982~No~RX~MEDICIS PHARMACEUTICAL CORP
HYDROCORTISONE~CREAM;TOPICAL~SYNACORT~MEDICIS~2.5%~A~087457~001~AT~Approved Prio
r to Jan 1, 1982~No~RX~MEDICIS PHARMACEUTICAL CORP
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~SYNALAR~MEDIMETRIKS PHARMS~0.01%~N~012787~0
04~AT~Approved Prior to Jan 1, 1982~Yes~RX~MEDIMETRIKS PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~SYNALAR~MEDIMETRIKS PHARMS~0.025%~N~012787~
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~SYNALAR~MEDIMETRIKS PHARMS~0.025%~N~012787~
FLUOCINOLONE ACETONIDE~CREAM;TOPICAL~SYNALAR-HP~MEDIMETRIKS PHARMS~0.2%~N~016161
~002~~Approved Prior to Jan 1, 1982~No~DISCN~MEDIMETRIKS PHARMACEUTICALS INC
TAZAROTENE~CREAM;TOPICAL~TAZORAC~ALLERGAN~0.05%~N~021184~001~~Sep 29, 2000~Yes~R
X~ALLERGAN INC
TAZAROTENE~CREAM;TOPICAL~TAZORAC~ALLERGAN~0.1%~N~021184~002~~Sep 29, 2000~Yes~RX
~ALLERGAN INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~TEMOVATE~FOUGERA PHARMS~0.05%~N~019322~001~A
B1~Dec 27, 1985~Yes~RX~FOUGERA PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~CREAM;TOPICAL~TEMOVATE E~FOUGERA PHARMS~0.05%~N~020340~001
~AB2~Jun 17, 1994~Yes~RX~FOUGERA PHARMACEUTICALS INC
TERBINAFINE HYDROCHLORIDE~CREAM;TOPICAL~TERBINAFINE HYDROCHLORIDE~TARO~1%~A~0775
11~001~~Jul 2, 2007~No~OTC~TARO PHARMACEUTICALS USA INC
SILVER SULFADIAZINE~CREAM;TOPICAL~THERMAZENE~THEPHARMANETWORK LLC~1%~N~018810~00
1~AB~Dec 23, 1985~No~RX~THEPHARMANETWORK LLC
DESOXIMETASONE~CREAM;TOPICAL~TOPICORT~TARO~0.05%~A~073210~001~~Nov 30, 1990~Yes~
RX~TARO PHARMACEUTICALS INC
DESOXIMETASONE~CREAM;TOPICAL~TOPICORT~TARO~0.25%~A~073193~001~AB~Nov 30, 1990~Ye
s~RX~TARO PHARMACEUTICALS INC
DESOXIMETASONE~CREAM;TOPICAL~TOPICORT~TARO PHARMS NORTH~0.25% **Federal Register
determination that product was not discontinued or withdrawn for safety or effi
cacy reasons**~N~017856~001~~Approved Prior to Jan 1, 1982~No~DISCN~TARO PHARMAC
EUTICALS NORTH AMERICA INC
DESOXIMETASONE~CREAM;TOPICAL~TOPICORT LP~TARO PHARMS NORTH~0.05%~N~018309~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS NORTH AMERICA INC
TRETINOIN~CREAM;TOPICAL~TRETINOIN~MATAWAN PHARMS~0.025%~A~075264~001~AB~Dec 24,
1998~No~RX~MATAWAN PHARMACEUTICALS LLC
TRETINOIN~CREAM;TOPICAL~TRETINOIN~MATAWAN PHARMS~0.05%~A~075265~001~AB1~Dec 24,
TRETINOIN~CREAM;TOPICAL~TRETINOIN~MATAWAN PHARMS~0.1%~A~075213~001~AB~Dec 24, 19
TRETINOIN~CREAM;TOPICAL~TRETINOIN~SUNEVA MEDCL~0.05%~A~076498~001~AB2~Sep 15, 20
05~No~RX~SUNEVA MEDICAL INC

TRETINOIN~CREAM;TOPICAL~TRETINOIN~WATSON LABS INC~0.0375%~A~090098~001~~Mar 22,
2010~Yes~RX~WATSON LABORATORIES INC
TRETINOIN~CREAM;TOPICAL~TRETINOIN~WATSON LABS INC~0.075%~A~202209~001~~Oct 11, 2
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN~CREAM;TOPICAL~TRI-LUMA~GALDERMA
LABS LP~0.01%;4%;0.05%~N~021112~001~~Jan 18, 2002~Yes~RX~GALDERMA LABORATORIES L
P
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIACET~TEVA~0.025%~A~084908~001~~Approved
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIACET~TEVA~0.1%~A~084908~002~~Approved P
rior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIACET~TEVA~0.5%~A~084908~003~~Approved P
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIACORT~SOLVAY~0.1%~A~087113~001~~Approve
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~ACTAVIS MID ATLANT
IC~0.1%~A~087798~001~~Jun 4, 1982~No~DISCN~ACTAVIS MID ATLANTIC LLC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~ALPHARMA US PHARMS
~0.025%~A~087797~001~~Jun 7, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~AMBIX~0.025%~A~087
932~001~~May 9, 1983~No~DISCN~AMBIX LABORATORIES DIV ORGANICS CORP AMERICA
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~FOUGERA PHARMS~0.0
25%~A~085692~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~FOUGERA PHARMACEUTICALS
INC
%~A~085692~003~AT~Approved Prior to Jan 1, 1982~Yes~RX~FOUGERA PHARMACEUTICALS I
NC
%~A~085692~002~AT~Approved Prior to Jan 1, 1982~Yes~RX~FOUGERA PHARMACEUTICALS I
NC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~G AND W LABS~0.025
%~A~089797~001~~May 31, 1991~No~DISCN~G AND W LABORATORIES INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~G AND W LABS~0.1%~
A~089798~001~~May 31, 1991~No~DISCN~G AND W LABORATORIES INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~MORTON GROVE~0.025
%~A~088094~001~~Sep 1, 1983~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~MORTON GROVE~0.1%~
A~088095~001~~Sep 1, 1983~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~MORTON GROVE~0.5%~
A~088096~001~~Sep 1, 1983~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~PERRIGO NEW YORK~0
.025%~A~086415~001~AT~Approved Prior to Jan 1, 1982~No~RX~PERRIGO NEW YORK INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~PHARMADERM~0.025%~
A~087990~001~~Jul 7, 1983~No~DISCN~PHARMADERM DIV ALTANA INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~PHARMADERM~0.1%~A~
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~PHARMADERM~0.5%~A~
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~PHARMAFAIR~0.025%~
A~087921~001~~Aug 10, 1982~No~DISCN~PHARMAFAIR INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~PHARMAFAIR~0.1%~A~
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~PHARMAFAIR~0.5%~A~
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~TARO~0.025%~A~0400
38~001~~Oct 26, 1994~No~DISCN~TARO PHARMACEUTICALS INC

77~001~~Approved Prior to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
~001~AT~Nov 26, 1997~No~RX~TARO PHARMACEUTICALS INC
~001~~Approved Prior to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
~001~~Approved Prior to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~TOPIDERM~0.025%~A~
089274~001~~Feb 21, 1989~No~DISCN~TOPIDERM INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~TOPIDERM~0.1%~A~08
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~TOPIDERM~0.5%~A~08
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~VINTAGE~0.025%~A~0
40671~001~AT~Jun 9, 2006~No~RX~VINTAGE PHARMACEUTICALS LLC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIAMCINOLONE ACETONIDE~VINTAGE~0.1%~A~040
671~002~AT~Jun 9, 2006~No~RX~VINTAGE PHARMACEUTICALS LLC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIATEX~IVAX PHARMS~0.025%~A~087430~001~~N
ov 1, 1988~No~DISCN~IVAX PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIATEX~IVAX PHARMS~0.1%~A~087429~001~~Nov
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIATEX~IVAX PHARMS~0.5%~A~087428~001~~Nov
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRIDERM~CROWN LABS~0.1%~A~088042~001~AT~Ma
r 19, 1984~No~RX~CROWN LABORATORIES INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRYMEX~SAVAGE LABS~0.025%~A~088196~001~~Ma
r 25, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRYMEX~SAVAGE LABS~0.1%~A~088197~001~~Mar
25, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
TRIAMCINOLONE ACETONIDE~CREAM;TOPICAL~TRYMEX~SAVAGE LABS~0.5%~A~088198~001~~Mar
TIOCONAZOLE~CREAM;TOPICAL~TZ-3~PFIZER~1%~N~018682~001~~Feb 18, 1983~No~DISCN~PFI
ZER LABORATORIES DIV PFIZER INC
HYDROCORTISONE ACETATE; UREA~CREAM;TOPICAL~U-CORT~TARO~1%;10%~A~089472~001~~Jun
13, 1988~No~RX~TARO PHARMACEUTICALS USA INC
HALOBETASOL PROPIONATE~CREAM;TOPICAL~ULTRAVATE~RANBAXY~0.05%~N~019967~001~AB~Dec
27, 1990~Yes~RX~RANBAXY LABORATORIES INC
BETAMETHASONE BENZOATE~CREAM;TOPICAL~UTICORT~PARKE DAVIS~0.025%~N~016998~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
BETAMETHASONE VALERATE~CREAM;TOPICAL~VALISONE~SCHERING~EQ 0.01% BASE~N~016322~00
BETAMETHASONE VALERATE~CREAM;TOPICAL~VALISONE~SCHERING~EQ 0.1% BASE~N~016322~001
BETAMETHASONE VALERATE~CREAM;TOPICAL~VALNAC~ACTAVIS MID ATLANTIC~EQ 0.1% BASE~A~
070050~001~AB~Oct 10, 1984~No~RX~ACTAVIS MID ATLANTIC LLC
EFLORNITHINE HYDROCHLORIDE~CREAM;TOPICAL~VANIQA~SKINMEDICA~13.9%~N~021145~001~~J
ul 27, 2000~Yes~RX~SKINMEDICA INC
FLUOCINONIDE~CREAM;TOPICAL~VANOS~MEDICIS~0.1%~N~021758~001~AB~Feb 11, 2005~Yes~R
X~MEDICIS PHARMACEUTICAL CORP
HYDROCORTISONE VALERATE~CREAM;TOPICAL~WESTCORT~RANBAXY~0.2%~N~017950~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~RANBAXY LABORATORIES INC
ACYCLOVIR; HYDROCORTISONE~CREAM;TOPICAL~XERESE~VALEANT BERMUDA~5%;1%~N~022436~00
1~~Jul 31, 2009~Yes~RX~VALEANT INTERNATIONAL BERMUDA
DOXEPIN HYDROCHLORIDE~CREAM;TOPICAL~ZONALON~FOUGERA PHARMS~5%~N~020126~001~~Apr
1, 1994~Yes~RX~FOUGERA PHARMACEUTICALS INC
ACYCLOVIR~CREAM;TOPICAL~ZOVIRAX~VALEANT BERMUDA~5%~N~021478~001~~Dec 30, 2002~Ye
s~RX~VALEANT INTERNATIONAL BERMUDA
IMIQUIMOD~CREAM;TOPICAL~ZYCLARA~MEDICIS~2.5%~N~022483~002~~Jul 15, 2011~Yes~RX~M
EDICIS PHARMACEUTICAL CORP

IMIQUIMOD~CREAM;TOPICAL~ZYCLARA~MEDICIS~3.75%~N~022483~001~~Mar 25, 2010~Yes~RX~
MEDICIS PHARMACEUTICAL CORP
MICONAZOLE NITRATE~CREAM;TOPICAL, VAGINAL~MICONAZOLE 3 COMBINATION PACK~PERRIGO~
2%,4%~A~076357~001~~Mar 30, 2004~No~OTC~L PERRIGO CO
MICONAZOLE NITRATE~CREAM;TOPICAL, VAGINAL~MONISTAT 3 COMBINATION PACK~MEDTECH PR
ODUCTS~2%,4%~N~021261~003~~Jun 17, 2003~No~OTC~MEDTECH PRODUCTS INC
MICONAZOLE NITRATE~CREAM;TOPICAL, VAGINAL~MONISTAT 3 COMBINATION PACK (PREFILLED
)~MEDTECH PRODUCTS~2%,4%~N~021261~001~~Feb 2, 2001~Yes~OTC~MEDTECH PRODUCTS INC
ESTROGENS, CONJUGATED~CREAM;TOPICAL, VAGINAL~PREMARIN~WYETH PHARMS INC~0.625MG/G
M~N~020216~001~~Approved Prior to Jan 1, 1982~Yes~RX~WYETH PHARMACEUTICALS INC
SULFANILAMIDE~CREAM;VAGINAL~AVC~MEDA PHARMS~15%~N~006530~003~~Jan 27, 1987~Yes~R
X~MEDA PHARMACEUTICALS INC
BUTOCONAZOLE NITRATE~CREAM;VAGINAL~BUTOCONAZOLE NITRATE~PERRIGO ISRAEL~2%~A~2009
23~001~~May 18, 2012~Yes~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
CLINDAMYCIN PHOSPHATE~CREAM;VAGINAL~CLEOCIN~PHARMACIA AND UPJOHN~EQ 2% BASE~N~05
CLINDAMYCIN PHOSPHATE~CREAM;VAGINAL~CLEOCIN~PHARMACIA AND UPJOHN~EQ 2% BASE~N~05
0680~002~AB~Mar 2, 1998~Yes~RX~PHARMACIA AND UPJOHN CO
CLINDAMYCIN PHOSPHATE~CREAM;VAGINAL~CLINDAMYCIN PHOSPHATE~FOUGERA PHARMS~EQ 2% B
ASE~A~065139~001~AB~Dec 27, 2004~No~RX~FOUGERA PHARMACEUTICALS INC
CLINDAMYCIN PHOSPHATE~CREAM;VAGINAL~CLINDESSE~ELAN PHARMA INTL LTD~EQ 2% BASE~N~
050793~001~~Nov 30, 2004~Yes~RX~ELAN PHARMA INTERNATIONAL LTD
CLOTRIMAZOLE~CREAM;VAGINAL~CLOTRIMAZOLE~ACTAVIS MID ATLANTIC~1%~A~074165~001~~Ju
l 16, 1993~No~OTC~ACTAVIS MID ATLANTIC LLC
CLOTRIMAZOLE~CREAM;VAGINAL~CLOTRIMAZOLE~TARO~1%~A~072641~001~~Dec 4, 1995~No~OTC
~TARO PHARMACEUTICALS INC
DIENESTROL~CREAM;VAGINAL~DIENESTROL~ORTHO MCNEIL PHARM~0.01%~N~006110~005~~Appro
ved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
DIENESTROL~CREAM;VAGINAL~DV~SANOFI AVENTIS US~0.01%~A~083518~001~~Approved Prior
to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
ESTRADIOL~CREAM;VAGINAL~ESTRACE~WARNER CHILCOTT US~0.01%~A~086069~001~~Jan 31, 1
984~Yes~RX~WARNER CHILCOTT US LLC
DIENESTROL~CREAM;VAGINAL~ESTRAGUARD~SOLVAY~0.01%~A~084436~001~~Approved Prior to
Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
BUTOCONAZOLE NITRATE~CREAM;VAGINAL~FEMSTAT~ROCHE PALO~2%~N~019215~001~~Nov 25, 1
985~No~DISCN~ROCHE PALO ALTO LLC
BUTOCONAZOLE NITRATE~CREAM;VAGINAL~FEMSTAT 3~BAYER~2%~N~020421~001~~Dec 21, 1995
~Yes~OTC~BAYER HEALTHCARE LLC
BUTOCONAZOLE NITRATE~CREAM;VAGINAL~GYNAZOLE-1~ELAN PHARMA INTL LTD~2%~N~019881~0
01~~Feb 7, 1997~No~DISCN~ELAN PHARMA INTERNATIONAL LTD
CLOTRIMAZOLE~CREAM;VAGINAL~GYNE-LOTRIMIN~SCHERING PLOUGH~1%~N~018052~002~~Nov 30
, 1990~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
CLOTRIMAZOLE~CREAM;VAGINAL~GYNE-LOTRIMIN 3~SCHERING PLOUGH~2%~N~020574~001~~Nov
24, 1998~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)~CREAM;VAGINAL~GYNE-SUL
F~G AND W LABS~3.7%;2.86%;3.42%~A~088607~001~~Jun 9, 1986~No~DISCN~G AND W LABOR
ATORIES INC
MICONAZOLE NITRATE~CREAM;VAGINAL~MICONAZOLE 3~TARO~4%~A~076773~001~~Mar 2, 2005~
No~OTC~TARO PHARMACEUTICALS USA INC
MICONAZOLE NITRATE~CREAM;VAGINAL~MICONAZOLE 7~ACTAVIS MID ATLANTIC~2%~A~074164~0
01~~Mar 29, 1996~No~OTC~ACTAVIS MID ATLANTIC LLC
MICONAZOLE NITRATE~CREAM;VAGINAL~MICONAZOLE NITRATE~G AND W LABS INC~2%~A~074366
~001~~Feb 22, 1996~No~OTC~G AND W LABORATORIES INC
MICONAZOLE NITRATE~CREAM;VAGINAL~MICONAZOLE NITRATE~PERRIGO~2%~A~074760~001~~May
15, 1997~No~OTC~L PERRIGO CO
MICONAZOLE NITRATE~CREAM;VAGINAL~MICONAZOLE NITRATE~PERRIGO R AND D~4%~A~091366~
001~~Jan 15, 2010~No~OTC~PERRIGO R AND D CO
MICONAZOLE NITRATE~CREAM;VAGINAL~MICONAZOLE NITRATE~TARO~2%~A~074444~001~~Jan 13
, 1997~No~OTC~TARO PHARMACEUTICALS INC
MICONAZOLE NITRATE~CREAM;VAGINAL~MICONAZOLE NITRATE~TEVA~2%~A~074136~001~~Jan 4,

1995~No~DISCN~TEVA PHARMACEUTICALS USA INC
MICONAZOLE NITRATE~CREAM;VAGINAL~MICONAZOLE NITRATE~TEVA PHARMS~2%~A~074030~001~
~Oct 30, 1992~No~DISCN~TEVA PHARMACEUTICALS USA
MICONAZOLE NITRATE~CREAM;VAGINAL~MONISTAT 3~MEDTECH PRODUCTS~4%~N~020827~001~~Ma
r 30, 1998~Yes~OTC~MEDTECH PRODUCTS INC
MICONAZOLE NITRATE~CREAM;VAGINAL~MONISTAT 7~MEDTECH PRODUCTS~2%~N~017450~002~~Fe
b 15, 1991~Yes~OTC~MEDTECH PRODUCTS INC
CLOTRIMAZOLE~CREAM;VAGINAL~MYCELEX-7~BAYER HEALTHCARE LLC~1%~N~018230~002~~Dec 2
6, 1991~No~OTC~BAYER HEALTHCARE LLC
ESTROPIPATE~CREAM;VAGINAL~OGEN~PHARMACIA AND UPJOHN~1.5MG/GM~A~084710~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
SULFANILAMIDE~CREAM;VAGINAL~SULFANILAMIDE~TEVA~15%~A~088718~001~~Sep 19, 1985~No
~DISCN~TEVA PHARMACEUTICALS USA INC
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)~CREAM;VAGINAL~SULTRIN~
ORTHO MCNEIL PHARM~3.7%;2.86%;3.42%~N~005794~001~~Approved Prior to Jan 1, 1982~
No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
ESTROGENS, CONJUGATED SYNTHETIC A~CREAM;VAGINAL~SYNTHETIC CONJUGATED ESTROGENS A
~TEVA WOMENS~0.625MG/GM~N~021788~001~~Nov 28, 2008~No~DISCN~TEVA WOMENS HEALTH I
NC
TERCONAZOLE~CREAM;VAGINAL~TERAZOL 3~JANSSEN PHARMS~0.8%~N~019964~001~AB~Feb 21,
TERCONAZOLE~CREAM;VAGINAL~TERAZOL 7~JANSSEN PHARMS~0.4%~N~019579~001~AB~Dec 31,
TERCONAZOLE~CREAM;VAGINAL~TERCONAZOLE~FOUGERA PHARMS~0.4%~A~076712~001~AB~Feb 18
, 2005~No~RX~FOUGERA PHARMACEUTICALS INC
TERCONAZOLE~CREAM;VAGINAL~TERCONAZOLE~NYCOMED US~0.8%~N~021735~001~BX~Oct 1, 200
4~Yes~RX~NYCOMED US INC
TERCONAZOLE~CREAM;VAGINAL~TERCONAZOLE~TARO~0.4%~A~076043~001~AB~Jan 19, 2005~No~
RX~TARO PHARMACEUTICALS USA INC
TERCONAZOLE~CREAM;VAGINAL~TERCONAZOLE~TARO~0.8%~A~075953~001~AB~Apr 6, 2004~No~R
X~TARO PHARMACEUTICALS USA INC
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)~CREAM;VAGINAL~TRIPLE S
ULFA~ALPHARMA US PHARMS~3.7%;2.86%;3.42%~A~087864~001~~Sep 1, 1982~No~DISCN~ALPH
ARMA US PHARMACEUTICALS DIVISION
ULFA~FOUGERA~3.7%;2.86%;3.42%~A~086424~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~E FOUGERA DIV ALTANA INC
ULFA~PERRIGO NEW YORK~3.7%;2.86%;3.42%~A~087285~001~~Nov 15, 1982~No~DISCN~PERRI
GO NEW YORK INC
CLOTRIMAZOLE~CREAM;VAGINAL~TRIVAGIZOLE 3~TARO~2%~N~021143~001~~Apr 12, 2000~No~O
TC~TARO PHARMACEUTICALS USA INC
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)~CREAM;VAGINAL~TRYSUL~S
AVAGE LABS~3.7%;2.86%;3.42%~A~087887~001~~Jul 23, 1982~No~DISCN~SAVAGE LABORATOR
IES INC DIV ALTANA INC
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)~CREAM;VAGINAL~VAGILIA~
TEVA~3.7%;2.86%;3.42%~A~088821~001~~Nov 9, 1987~No~DISCN~TEVA PHARMACEUTICALS US
A INC
ISOPROTERENOL HYDROCHLORIDE~DISC;INHALATION~NORISODRINE AEROTROL~ABBOTT~0.25%~N~
016814~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEU
TICAL PRODUCTS DIV
BETAMETHASONE DIPROPIONATE~DISC;TOPICAL~DIPROSONE~SCHERING~EQ 0.1% BASE~N~017829
~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH C
ORP
LIDOCAINE; PRILOCAINE~DISC;TOPICAL~EMLA~ASTRAZENECA~2.5%;2.5%~N~020962~001~~Feb
4, 1998~No~DISCN~ASTRAZENECA LP
BACITRACIN; POLYMYXIN B SULFATE~DISC;TOPICAL~LANABIOTIC~COMBE~500 UNITS/GM;5,000
UNITS/GM~N~050598~001~~Sep 22, 1986~No~DISCN~COMBE INC
NITROFURAZONE~DRESSING;TOPICAL~ACTIN-N~SHERWOOD MEDCL~0.2%~N~017343~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~SHERWOOD MEDICAL CO

SILVER SULFADIAZINE~DRESSING;TOPICAL~SILDAFLO~FRANKLIN PHARMS~1%~N~019608~001~~N
ov 30, 1989~No~DISCN~FRANKLIN PHARMACEUTICALS INC
TRIHEXYPHENIDYL HYDROCHLORIDE~ELIXIR;ORAL~ARTANE~LEDERLE~2MG/5ML~N~006773~009~~A
pproved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID
CO
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~BELIX~HALSEY~12.5MG/5ML~A~086586~001~~
Oct 3, 1983~No~DISCN~HALSEY DRUG CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~BENADRYL~MCNEIL CONS~12.5MG/5ML~N~0058
45~004~~Approved Prior to Jan 1, 1982~No~DISCN~MCNEIL CONSUMER HEALTHCARE
BROMPHENIRAMINE MALEATE~ELIXIR;ORAL~BROMPHENIRAMINE MALEATE~ALPHARMA US PHARMS~2
MG/5ML~A~086936~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACE
UTICALS DIVISION
BROMPHENIRAMINE MALEATE~ELIXIR;ORAL~BROMPHENIRAMINE MALEATE~KV PHARM~2MG/5ML~A~0
85466~001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
BROMPHENIRAMINE MALEATE~ELIXIR;ORAL~BROMPHENIRAMINE MALEATE~PHARM ASSOC~2MG/5ML~
A~087517~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL ASSOC INC DI
V BEACH PRODUCTS
BROMPHENIRAMINE MALEATE~ELIXIR;ORAL~BROMPHENIRAMINE MALEATE~USL PHARMA~2MG/5ML~A
~087964~001~~Jan 25, 1983~No~DISCN~USL PHARMA INC
BUTABARBITAL SODIUM~ELIXIR;ORAL~BUTABARB~ALPHARMA US PHARMS~30MG/5ML~A~085873~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
BUTABARBITAL SODIUM~ELIXIR;ORAL~BUTABARBITAL SODIUM~WOCKHARDT~30MG/5ML~A~085383~
001~~Approved Prior to Jan 1, 1982~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
BUTABARBITAL SODIUM~ELIXIR;ORAL~BUTALAN~LANNETT~33.3MG/5ML~A~085880~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
BUTABARBITAL SODIUM~ELIXIR;ORAL~BUTISOL SODIUM~MEDA PHARMS~30MG/5ML~A~085380~001
~~Approved Prior to Jan 1, 1982~Yes~RX~MEDA PHARMACEUTICALS INC
CARBINOXAMINE MALEATE~ELIXIR;ORAL~CLISTIN~MCNEIL~4MG/5ML **Federal Register dete
reasons**~N~008955~001~~Approved Prior to Jan 1, 1982~No~DISCN~MCNEIL PHARMACEUT
ICAL CO DIV MCNEILAB INC
DEXAMETHASONE~ELIXIR;ORAL~DECADRON~MERCK~0.5MG/5ML~N~012376~002~~Approved Prior
to Jan 1, 1982~No~DISCN~MERCK AND CO INC
DEXAMETHASONE~ELIXIR;ORAL~DEXAMETHASONE~ALPHARMA US PHARMS~0.5MG/5ML~A~088997~00
1~~Oct 10, 1986~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
DEXAMETHASONE~ELIXIR;ORAL~DEXAMETHASONE~LYNE~0.5MG/5ML~A~090891~001~AA~Jul 12, 2
DEXAMETHASONE~ELIXIR;ORAL~DEXAMETHASONE~STI PHARMA LLC~0.5MG/5ML~A~084754~001~AA
~Approved Prior to Jan 1, 1982~Yes~RX~STI PHARMA LLC
DEXAMETHASONE~ELIXIR;ORAL~DEXAMETHASONE~VINTAGE PHARMS~0.5MG/5ML~A~091188~001~AA
~May 11, 2011~No~RX~VINTAGE PHARMACEUTICALS INC
DEXAMETHASONE~ELIXIR;ORAL~DEXAMETHASONE~WOCKHARDT EU OPERATN~0.5MG/5ML~A~088254~
001~AA~Jul 27, 1983~No~RX~WOCKHARDT EU OPERATIONS SWISS AG
DEXTROAMPHETAMINE SULFATE~ELIXIR;ORAL~DEXEDRINE~GLAXOSMITHKLINE~5MG/5ML **Federa
l Register determination that product was not discontinued or withdrawn for safe
ty or efficacy reasons**~A~083902~001~~Approved Prior to Jan 1, 1982~No~DISCN~GL
AXOSMITHKLINE
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIBENIL~CENCI~12.5MG/5ML~A~088304~001~
~Dec 16, 1983~No~DISCN~HR CENCI LABORATORIES INC
DIGOXIN~ELIXIR;ORAL~DIGOXIN~ROXANE~0.05MG/ML~N~021648~001~~Aug 26, 2004~Yes~RX~R
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHEN~USL PHARMA~12.5MG/5ML~A~084640~
001~~Approved Prior to Jan 1, 1982~No~DISCN~USL PHARMA INC
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~BUNDY~12
.5MG/5ML~A~083674~001~~Approved Prior to Jan 1, 1982~No~DISCN~CM BUNDY CO
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~CENCI~12
.5MG/5ML~A~087941~001~~Dec 17, 1982~No~DISCN~HR CENCI LABORATORIES INC
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~KV PHARM
~12.5MG/5ML~A~085621~001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTIC
AL CO
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LANNETT~
12.5MG/5ML~A~080939~002~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LEDERLE~
12.5MG/5ML~A~086937~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATO
RIES DIV AMERICAN CYANAMID CO
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~MK LABS~
12.5MG/5ML~A~083088~002~~Approved Prior to Jan 1, 1982~No~DISCN~MK LABORATORIES
INC
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~NASKA~12
.5MG/5ML~A~088680~001~~May 31, 1985~No~DISCN~NASKA PHARMACAL CO INC DIV RUGBY DA
RBY GROUP COSMETICS
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PERRIGO~
12.5MG/5ML~A~083063~001~~Approved Prior to Jan 1, 1982~No~DISCN~L PERRIGO CO
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PHARM AS
SOC~12.5MG/5ML~A~087513~001~~Feb 10, 1982~Yes~RX~PHARMACEUTICAL ASSOC INC DIV BE
ACH PRODUCTS
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PUREPAC
PHARM~12.5MG/5ML~A~083237~001~~Jan 25, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~PVT FORM
~12.5MG/5ML~A~085287~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULA
TIONS INC
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~ROXANE~1
2.5MG/5ML~A~080643~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORI
ES INC
THEOPHYLLINE~ELIXIR;ORAL~ELIXOMIN~CENCI~80MG/15ML~A~088303~001~~Jan 25, 1984~No~
DISCN~HR CENCI LABORATORIES INC
FLUPHENAZINE HYDROCHLORIDE~ELIXIR;ORAL~FLUPHENAZINE HYDROCHLORIDE~ANI PHARMS INC
~2.5MG/5ML~A~081310~001~~Apr 29, 1993~No~DISCN~ANI PHARMACEUTICALS INC
FLUPHENAZINE HYDROCHLORIDE~ELIXIR;ORAL~FLUPHENAZINE HYDROCHLORIDE~PHARM ASSOC~2.
5MG/5ML~A~040146~001~~Aug 21, 1996~Yes~RX~PHARMACEUTICAL ASSOC INC DIV BEACH PRO
DUCTS
DEXAMETHASONE~ELIXIR;ORAL~HEXADROL~ORGANON USA INC~0.5MG/5ML~N~012674~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
DIPHENHYDRAMINE HYDROCHLORIDE~ELIXIR;ORAL~HYDRAMINE~ALPHARMA US PHARMS~12.5MG/5M
L~A~080763~002~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACEUTICA
LS DIVISION
THEOPHYLLINE~ELIXIR;ORAL~LANOPHYLLIN~LANNETT~80MG/15ML~A~084578~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~LANNETT CO INC
ETHYLESTRENOL~ELIXIR;ORAL~MAXIBOLIN~ORGANON USA INC~2MG/5ML~N~014006~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
PENTOBARBITAL~ELIXIR;ORAL~NEMBUTAL~OAK PHARMS~18.2MG/5ML~A~083244~001~~Approved
Prior to Jan 1, 1982~No~DISCN~OAK PHARMACEUTICALS INC
DYPHYLLINE~ELIXIR;ORAL~NEOTHYLLINE~TEVA~160MG/15ML~N~007794~003~~Approved Prior
METHYPRYLON~ELIXIR;ORAL~NOLUDAR~ROCHE~50MG/5ML~N~009660~007~~Approved Prior to J
an 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
TRIPELENNAMINE CITRATE~ELIXIR;ORAL~PBZ~NOVARTIS~EQ 25MG HCL/5ML~N~005914~004~~Ap
proved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
FLUPHENAZINE HYDROCHLORIDE~ELIXIR;ORAL~PROLIXIN~APOTHECON~2.5MG/5ML~N~012145~003
~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
BUTABARBITAL SODIUM~ELIXIR;ORAL~SARISOL~HALSEY~30MG/5ML~A~084723~001~~Approved P
rior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
RESERPINE~ELIXIR;ORAL~SERPASIL~NOVARTIS~0.2MG/4ML~N~009115~005~~Approved Prior t
o Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
THEOPHYLLINE SODIUM GLYCINATE~ELIXIR;ORAL~SYNOPHYLATE~CENT PHARMS~EQ 165MG BASE/
15ML~N~006333~008~~Approved Prior to Jan 1, 1982~No~DISCN~CENTRAL PHARMACEUTICAL
S INC
THEOPHYLLINE~ELIXIR;ORAL~THEOLIXIR~PANRAY~80MG/15ML~A~084559~001~~Approved Prior
to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYL-225~ORTHO MCNEIL PHARM~112.5MG/15ML~A~086485~0

01~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~ALPHARMA US PHARMS~80MG/15ML~A~089223~001~
~May 27, 1988~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~CENCI~80MG/15ML~A~087679~001~~Apr 15, 1982
~No~DISCN~CENCI POWDER PRODUCTS INC
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~HALSEY~80MG/15ML~A~085169~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~PERRIGO~80MG/15ML~A~085952~001~~Approved P
rior to Jan 1, 1982~No~DISCN~L PERRIGO CO
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~PHARM ASSOC~80MG/15ML~A~086720~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~PRECISION DOSE~80MG/15ML~A~085863~001~~App
roved Prior to Jan 1, 1982~No~DISCN~PRECISION DOSE INC
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~ROXANE~80MG/15ML~A~084739~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~TARO~80MG/15ML~A~089626~001~~Oct 28, 1988~
No~DISCN~TARO PHARMACEUTICALS USA INC
THEOPHYLLINE~ELIXIR;ORAL~THEOPHYLLINE~WOCKHARDT~80MG/15ML~A~086748~001~~Approved
Prior to Jan 1, 1982~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
TRIHEXYPHENIDYL HYDROCHLORIDE~ELIXIR;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~MIKART~2
MG/5ML~A~040251~001~AA~Sep 27, 1999~No~RX~MIKART INC
TRIHEXYPHENIDYL HYDROCHLORIDE~ELIXIR;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~PHARM AS
SOC~2MG/5ML~A~040177~001~AA~Apr 17, 1997~Yes~RX~PHARMACEUTICAL ASSOC INC DIV BEA
CH PRODUCTS
TRIHEXYPHENIDYL HYDROCHLORIDE~ELIXIR;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~PHARM VE
NTURES~2MG/5ML~A~089514~001~~Apr 7, 1989~No~DISCN~PHARMACEUTICAL VENTURES LTD
CLEVIDIPINE~EMULSION;INTRAVENOUS~CLEVIPREX~MEDICINES CO~25MG/50ML (0.5MG/ML)~N~0
22156~001~~Aug 1, 2008~Yes~RX~THE MEDICINES CO
CLEVIDIPINE~EMULSION;INTRAVENOUS~CLEVIPREX~MEDICINES CO~50MG/100ML (0.5MG/ML)~N~
022156~002~~Aug 1, 2008~Yes~RX~THE MEDICINES CO
CLEVIDIPINE~EMULSION;INTRAVENOUS~CLEVIPREX~MEDICINES CO~125MG/250ML (0.5MG/ML)~N
~022156~003~~Nov 8, 2013~Yes~RX~THE MEDICINES CO
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE;
SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL~EMULSION;IV (INFUSION)~KABI
VEN IN PLASTIC CONTAINER~FRESENIUS KABI USA~3.3%;29MG/100ML;9.8GM/100ML;96MG/100
ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)~N~200656~004~~Aug 2
5, 2014~No~RX~FRESENIUS KABI USA LLC
ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)~N~200656~005~~Aug 25
, 2014~No~RX~FRESENIUS KABI USA LLC
, 2014~No~RX~FRESENIUS KABI USA LLC
, 2014~Yes~RX~FRESENIUS KABI USA LLC
SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL~EMULSION;IV (INFUSION)~PERI
KABIVEN IN PLASTIC CONTAINER~FRESENIUS KABI USA~2.4%;20MG/100ML;6.8GM/100ML;68MG
/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)~N~200656~001~~Au
g 25, 2014~No~RX~FRESENIUS KABI USA LLC

/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)~N~200656~002~~Au
g 25, 2014~No~RX~FRESENIUS KABI USA LLC
/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)~N~200656~003~~A
ug 25, 2014~No~RX~FRESENIUS KABI USA LLC
DIFLUPREDNATE~EMULSION;OPHTHALMIC~DUREZOL~ALCON PHARMS LTD~0.05%~N~022212~001~~J
un 23, 2008~Yes~RX~ALCON PHARMACEUTICALS LTD
CYCLOSPORINE~EMULSION;OPHTHALMIC~RESTASIS~ALLERGAN~0.05%~N~050790~001~~Dec 23, 2
002~Yes~RX~ALLERGAN INC
SULFISOXAZOLE ACETYL~EMULSION;ORAL~LIPO GANTRISIN~ROCHE~EQ 1GM BASE/5ML~N~009182
~009~~Approved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
BENZYL BENZOATE~EMULSION;TOPICAL~BENZYL BENZOATE~LANNETT~50%~A~084535~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
ESTRADIOL HEMIHYDRATE~EMULSION;TOPICAL~ESTRASORB~MEDICIS~0.25%~N~021371~001~~Oct
9, 2003~Yes~RX~MEDICIS PHARMACEUTICAL CORP
HEXACHLOROPHENE~EMULSION;TOPICAL~HEXA-GERM~HUNTINGTON LABS~3%~N~017411~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~HUNTINGTON LABORATORIES INC
HEXACHLOROPHENE~EMULSION;TOPICAL~PHISOHEX~SANOFI AVENTIS US~3%~N~006882~001~~App
roved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
HEXACHLOROPHENE~EMULSION;TOPICAL~PHISOHEX~SANOFI AVENTIS US~3%~N~008402~001~~App
roved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
HEXACHLOROPHENE~EMULSION;TOPICAL~SOY-DOME~BAYER PHARMS~3%~N~017405~001~~Approved
HEXACHLOROPHENE~EMULSION;TOPICAL~TURGEX~XTTRIUM~3%~N~019055~001~~Nov 30, 1984~No
~DISCN~XTTRIUM LABORATORIES INC
HYDROCORTISONE~ENEMA;RECTAL~COLOCORT~PADDOCK LLC~100MG/60ML~A~075172~001~AB~Dec
3, 1999~No~RX~PADDOCK LABORATORIES LLC
HYDROCORTISONE~ENEMA;RECTAL~CORTENEMA~ANI PHARMS~100MG/60ML~N~016199~001~AB~Appr
oved Prior to Jan 1, 1982~Yes~RX~ANI PHARMACEUTICALS INC
HYDROCORTISONE~ENEMA;RECTAL~HYDROCORTISONE~TEVA PHARMS~100MG/60ML~A~074171~001~A
B~May 27, 1994~No~RX~TEVA PHARMACEUTICALS USA
METHYLPREDNISOLONE ACETATE~ENEMA;RECTAL~MEDROL~PHARMACIA AND UPJOHN~40MG/BOT~N~0
MESALAMINE~ENEMA;RECTAL~MESALAMINE~PERRIGO ISRAEL~4GM/60ML~A~076751~001~AB~Sep 1
7, 2004~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
MESALAMINE~ENEMA;RECTAL~MESALAMINE~TEVA~4GM/60ML~A~076841~001~AB~Sep 30, 2004~No
MESALAMINE~ENEMA;RECTAL~ROWASA~MEDA PHARMS~4GM/60ML~N~019618~001~AB~Dec 24, 1987
~Yes~RX~MEDA PHARMACEUTICALS INC
MESALAMINE~ENEMA;RECTAL~SFROWASA~MEDA PHARMS~4GM/60ML~N~019618~002~AB~Jun 20, 20
08~No~RX~MEDA PHARMACEUTICALS INC
AMINOPHYLLINE~ENEMA;RECTAL~SOMOPHYLLIN~FISONS~300MG/5ML~N~018232~001~~Apr 2, 198
2~No~DISCN~FISONS CORP
TETRACYCLINE HYDROCHLORIDE~FIBER, EXTENDED RELEASE;PERIODONTAL~ACTISITE~SCHIFF A
ND CO~12.7MG/FIBER~N~050653~001~~Mar 25, 1994~No~DISCN~SCHIFF AND CO
LIDOCAINE~FILM, EXTENDED RELEASE;BUCCAL~DENTIPATCH~NOVEN~23MG/PATCH~N~020575~001
~~May 21, 1996~No~DISCN~NOVEN PHARMACEUTICALS INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ALORA~WATSON LABS~0.025MG/24HR~N~02
0655~004~BX~Apr 5, 2002~No~RX~WATSON LABORATORIES INC
655~001~BX~Dec 20, 1996~No~RX~WATSON LABORATORIES INC
TESTOSTERONE~FILM, EXTENDED RELEASE;TRANSDERMAL~ANDRODERM~ACTAVIS LABS UT INC~2M
G/24HR~N~020489~003~~Oct 20, 2011~Yes~RX~ACTAVIS LABORATORIES UT INC
TESTOSTERONE~FILM, EXTENDED RELEASE;TRANSDERMAL~ANDRODERM~ACTAVIS LABS UT INC~2.

5MG/24HR~N~020489~001~~Sep 29, 1995~No~DISCN~ACTAVIS LABORATORIES UT INC
G/24HR~N~020489~004~~Oct 20, 2011~Yes~RX~ACTAVIS LABORATORIES UT INC
G/24HR~N~020489~002~~May 2, 1997~No~DISCN~ACTAVIS LABORATORIES UT INC
BUPRENORPHINE~FILM, EXTENDED RELEASE;TRANSDERMAL~BUTRANS~PURDUE PHARMA LP~5MCG/H
R~N~021306~001~~Jun 30, 2010~No~RX~PURDUE PHARMA LP
BUPRENORPHINE~FILM, EXTENDED RELEASE;TRANSDERMAL~BUTRANS~PURDUE PHARMA LP~7.5MCG
/HR~N~021306~005~~Jun 30, 2014~No~RX~PURDUE PHARMA LP
BUPRENORPHINE~FILM, EXTENDED RELEASE;TRANSDERMAL~BUTRANS~PURDUE PHARMA LP~10MCG/
HR~N~021306~002~~Jun 30, 2010~No~RX~PURDUE PHARMA LP
HR~N~021306~004~~Jul 25, 2013~No~RX~PURDUE PHARMA LP
HR~N~021306~003~~Jun 30, 2010~Yes~RX~PURDUE PHARMA LP
CLONIDINE~FILM, EXTENDED RELEASE;TRANSDERMAL~CATAPRES-TTS-1~BOEHRINGER INGELHEIM
~0.1MG/24HR~N~018891~001~AB~Oct 10, 1984~No~RX~BOEHRINGER INGELHEIM
~0.2MG/24HR~N~018891~002~AB~Oct 10, 1984~No~RX~BOEHRINGER INGELHEIM
~0.3MG/24HR~N~018891~003~AB~Oct 10, 1984~Yes~RX~BOEHRINGER INGELHEIM
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~CLIMARA~BAYER HLTHCARE~0.025MG/24HR
~N~020375~004~AB2~Mar 5, 1999~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~CLIMARA~BAYER HLTHCARE~0.0375MG/24H
R~N~020375~005~AB~May 27, 2003~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~CLIMARA~BAYER HLTHCARE~0.05MG/24HR~
N~020375~001~AB2~Dec 22, 1994~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~CLIMARA~BAYER HLTHCARE~0.06MG/24HR~
N~020375~006~AB~May 27, 2003~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~CLIMARA~BAYER HLTHCARE~0.075MG/24HR
~N~020375~003~AB2~Mar 23, 1998~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~CLIMARA~BAYER HLTHCARE~0.1MG/24HR~N
~020375~002~AB2~Dec 22, 1994~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ESTRADIOL; LEVONORGESTREL~FILM, EXTENDED RELEASE;TRANSDERMAL~CLIMARA PRO~BAYER H
LTHCARE~0.045MG/24HR;0.015MG/24HR~N~021258~001~~Nov 21, 2003~Yes~RX~BAYER HEALTH
CARE PHARMACEUTICALS INC
CLONIDINE~FILM, EXTENDED RELEASE;TRANSDERMAL~CLONIDINE~AVEVA~0.1MG/24HR~A~076157
~001~AB~Aug 18, 2009~No~RX~AVEVA DRUG DELIVERY SYSTEMS INC
CLONIDINE~FILM, EXTENDED RELEASE;TRANSDERMAL~CLONIDINE~BARR~0.1MG/24HR~A~079090~
001~AB~Aug 20, 2010~No~RX~BARR LABORATORIES INC
CLONIDINE~FILM, EXTENDED RELEASE;TRANSDERMAL~CLONIDINE~MYLAN TECHNOLOGIES~0.1MG/
24HR~A~076166~001~AB~Jul 16, 2010~No~RX~MYLAN TECHNOLOGIES INC
CLONIDINE~FILM, EXTENDED RELEASE;TRANSDERMAL~CLONIDINE~WATSON LABS INC~0.1MG/24H
R~A~090873~001~AB~May 6, 2014~No~RX~WATSON LABORATORIES INC

ESTRADIOL; NORETHINDRONE ACETATE~FILM, EXTENDED RELEASE;TRANSDERMAL~COMBIPATCH~N
OVEN PHARMS INC~0.05MG/24HR;0.14MG/24HR~N~020870~001~~Aug 7, 1998~No~RX~NOVEN PH
ARMACEUTICALS INC
ESTRADIOL; NORETHINDRONE ACETATE~FILM, EXTENDED RELEASE;TRANSDERMAL~COMBIPATCH~N
OVEN PHARMS INC~0.05MG/24HR;0.25MG/24HR~N~020870~002~~Aug 7, 1998~Yes~RX~NOVEN P
HARMACEUTICALS INC
METHYLPHENIDATE~FILM, EXTENDED RELEASE;TRANSDERMAL~DAYTRANA~NOVEN PHARMS INC~10M
G/9HR (1.1MG/HR)~N~021514~001~~Apr 6, 2006~No~RX~NOVEN PHARMACEUTICALS INC
G/9HR (3.3MG/HR)~N~021514~004~~Apr 6, 2006~Yes~RX~NOVEN PHARMACEUTICALS INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~DURAGESIC-100~JANSSEN PHARMS~100MCG/
HR~N~019813~001~AB~Aug 7, 1990~No~RX~JANSSEN PHARMACEUTICALS INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~DURAGESIC-12~JANSSEN PHARMS~12.5MCG/
HR~N~019813~005~AB~Feb 4, 2005~No~RX~JANSSEN PHARMACEUTICALS INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~DURAGESIC-25~JANSSEN PHARMS~25MCG/HR
~N~019813~004~AB~Aug 7, 1990~Yes~RX~JANSSEN PHARMACEUTICALS INC
~N~019813~003~AB~Aug 7, 1990~No~RX~JANSSEN PHARMACEUTICALS INC
~N~019813~002~AB~Aug 7, 1990~No~RX~JANSSEN PHARMACEUTICALS INC
SELEGILINE~FILM, EXTENDED RELEASE;TRANSDERMAL~EMSAM~SOMERSET~6MG/24HR~N~021336~0
01~~Feb 27, 2006~Yes~RX~SOMERSET PHARMACEUTICALS INC
SELEGILINE~FILM, EXTENDED RELEASE;TRANSDERMAL~EMSAM~SOMERSET~9MG/24HR~N~021336~0
02~~Feb 27, 2006~No~RX~SOMERSET PHARMACEUTICALS INC
SELEGILINE~FILM, EXTENDED RELEASE;TRANSDERMAL~EMSAM~SOMERSET~12MG/24HR~N~021336~
003~~Feb 27, 2006~No~RX~SOMERSET PHARMACEUTICALS INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESCLIM~WOMEN FIRST HLTHCARE~0.025MG
/24HR~N~020847~001~~Aug 4, 1998~No~DISCN~WOMEN FIRST HEALTHCARE INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESCLIM~WOMEN FIRST HLTHCARE~0.0375M
G/24HR~N~020847~002~~Aug 4, 1998~No~DISCN~WOMEN FIRST HEALTHCARE INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESCLIM~WOMEN FIRST HLTHCARE~0.05MG/
24HR~N~020847~003~~Aug 4, 1998~No~DISCN~WOMEN FIRST HEALTHCARE INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESCLIM~WOMEN FIRST HLTHCARE~0.075MG
/24HR~N~020847~004~~Aug 4, 1998~No~DISCN~WOMEN FIRST HEALTHCARE INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESCLIM~WOMEN FIRST HLTHCARE~0.1MG/2
4HR~N~020847~005~~Aug 4, 1998~No~DISCN~WOMEN FIRST HEALTHCARE INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADERM~NOVARTIS~0.05MG/24HR~N~01
9081~002~BX~Sep 10, 1986~No~RX~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADERM~NOVARTIS~0.1MG/24HR~N~019
081~003~BX~Sep 10, 1986~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~MYLAN TECHNOLOGIES~0.025M
G/24HR~A~075182~003~AB2~Jan 26, 2005~No~RX~MYLAN TECHNOLOGIES INC
G/24HR~A~201675~001~AB1~Dec 19, 2014~No~RX~MYLAN TECHNOLOGIES INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~MYLAN TECHNOLOGIES~0.0375
MG/24HR~A~075182~004~AB~Jul 20, 2006~No~RX~MYLAN TECHNOLOGIES INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~MYLAN TECHNOLOGIES~0.0375
MG/24HR~A~201675~002~AB1~Dec 19, 2014~No~RX~MYLAN TECHNOLOGIES INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~MYLAN TECHNOLOGIES~0.05MG
/24HR~A~075182~006~AB2~Feb 24, 2000~No~RX~MYLAN TECHNOLOGIES INC
/24HR~A~201675~003~AB1~Dec 19, 2014~No~RX~MYLAN TECHNOLOGIES INC
/24HR~A~075182~005~AB~Jul 20, 2006~No~RX~MYLAN TECHNOLOGIES INC
G/24HR~A~075182~002~AB2~Jan 26, 2005~No~RX~MYLAN TECHNOLOGIES INC

G/24HR~A~201675~004~AB1~Dec 19, 2014~No~RX~MYLAN TECHNOLOGIES INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~MYLAN TECHNOLOGIES~0.1MG/
24HR~A~075182~001~AB2~Feb 24, 2000~No~RX~MYLAN TECHNOLOGIES INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~MYLAN TECHNOLOGIES~0.1MG/
24HR~A~201675~005~AB1~Dec 19, 2014~No~RX~MYLAN TECHNOLOGIES INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~ORTHO MCNEIL PHARM~0.05MG
/24HR~N~021048~001~~Sep 20, 1999~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~ORTHO MCNEIL PHARM~0.075M
G/24HR~N~021048~002~~Sep 20, 1999~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~ESTRADIOL~ORTHO MCNEIL PHARM~0.1MG/
24HR~N~021048~003~~Sep 20, 1999~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
RIVASTIGMINE~FILM, EXTENDED RELEASE;TRANSDERMAL~EXELON~NOVARTIS~4.6MG/24HR~N~022
083~001~~Jul 6, 2007~No~RX~NOVARTIS PHARMACEUTICALS CORP
083~002~~Jul 6, 2007~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
2083~005~~Aug 31, 2012~No~RX~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~FEMPATCH~PARKE DAVIS~0.025MG/24HR~N
~020417~001~~Dec 3, 1996~No~DISCN~PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER
LAMBERT CO
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-100~AVEVA~100MCG/HR~A~07744
9~004~AB~Oct 20, 2008~No~RX~AVEVA DRUG DELIVERY SYSTEMS INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-100~LAVIPHARM LABS~100MCG/H
R~A~077051~004~AB~Aug 4, 2006~No~RX~LAVIPHARM LABORATORIES INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-100~MALLINCKRODT INC~100MCG
/HR~A~077154~004~AB~Feb 9, 2011~No~RX~MALLINCKRODT INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-100~MYLAN TECHNOLOGIES~100M
CG/HR~A~076258~004~AB~Jan 28, 2005~No~RX~MYLAN TECHNOLOGIES INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-100~NOVEN~100MCG/HR~A~07777
5~004~~Oct 16, 2009~No~DISCN~NOVEN PHARMACEUTICALS INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-100~PAR PHARM INC~100MCG/HR
~A~077062~004~AB~Aug 20, 2007~No~RX~PAR PHARMACEUTICAL INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-100~WATSON LABS~100MCG/HR~A
~076709~004~AB~Aug 20, 2007~No~RX~WATSON LABORATORIES INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-12~MYLAN TECHNOLOGIES~12.5M
CG/HR~A~076258~005~AB~Jan 23, 2007~No~RX~MYLAN TECHNOLOGIES INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-25~AVEVA~25MCG/HR~A~077449~
001~AB~Oct 20, 2008~No~RX~AVEVA DRUG DELIVERY SYSTEMS INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-25~LAVIPHARM LABS~25MCG/HR~
A~077051~001~AB~Aug 4, 2006~No~RX~LAVIPHARM LABORATORIES INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-25~MALLINCKRODT INC~25MCG/H
R~A~077154~001~AB~Feb 9, 2011~No~RX~MALLINCKRODT INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-25~MYLAN TECHNOLOGIES~25MCG
/HR~A~076258~001~AB~Jan 28, 2005~No~RX~MYLAN TECHNOLOGIES INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-25~NOVEN~25MCG/HR~A~077775~
001~~Oct 16, 2009~No~DISCN~NOVEN PHARMACEUTICALS INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-25~PAR PHARM INC~25MCG/HR~A
~077062~001~AB~Aug 20, 2007~No~RX~PAR PHARMACEUTICAL INC
FENTANYL~FILM, EXTENDED RELEASE;TRANSDERMAL~FENTANYL-25~WATSON LABS~25MCG/HR~A~0
76709~001~AB~Aug 20, 2007~No~RX~WATSON LABORATORIES INC
CG/HR~A~076258~006~~Dec 29, 2014~No~RX~MYLAN TECHNOLOGIES INC

NICOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~HABITROL~DR REDDYS LABS INC~7MG/24HR
~N~020076~004~~Nov 12, 1999~Yes~OTC~DR REDDYS LABORATORIES INC
NICOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~HABITROL~DR REDDYS LABS INC~14MG/24H
R~N~020076~005~~Nov 12, 1999~Yes~OTC~DR REDDYS LABORATORIES INC
NICOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~HABITROL~DR REDDYS LABS INC~21MG/24H
R~N~020076~006~~Nov 12, 1999~Yes~OTC~DR REDDYS LABORATORIES INC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~MENOSTAR~BAYER HLTHCARE~0.014MG/24H
R~N~021674~001~~Jun 8, 2004~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~MINITRAN~MEDICIS~0.2MG/HR~A~089
772~001~AB1~Aug 30, 1996~No~RX~MEDICIS PHARMACEUTICAL CORP
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~MINITRAN~MEDICIS~0.4MG/HR~A~089
773~001~AB1~Aug 30, 1996~No~RX~MEDICIS PHARMACEUTICAL CORP
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~MINITRAN~VALEANT PHARMS~0.1MG/H
R~A~089771~001~AB1~Aug 30, 1996~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~MINITRAN~VALEANT PHARMS~0.6MG/H
R~A~089774~001~AB1~Aug 30, 1996~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~MINIVELLE~NOVEN~0.025MG/24HR~N~2037
52~005~~Sep 23, 2014~No~RX~NOVEN PHARMACEUTICALS INC
752~001~~Oct 29, 2012~No~RX~NOVEN PHARMACEUTICALS INC
~004~~Oct 29, 2012~Yes~RX~NOVEN PHARMACEUTICALS INC
ROTIGOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~NEUPRO~UCB INC~1MG/24HR~N~021829~0
04~~Apr 2, 2012~No~RX~UCB INC
01~~May 9, 2007~Yes~RX~UCB INC
02~~May 9, 2007~No~RX~UCB INC

03~~May 9, 2007~No~RX~UCB INC
NICOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~NICODERM CQ~SANOFI AVENTIS US~7MG/24
HR~N~020165~006~~Aug 2, 1996~Yes~OTC~SANOFI AVENTIS US LLC
4HR~N~020165~005~~Aug 2, 1996~Yes~OTC~SANOFI AVENTIS US LLC
4HR~N~020165~004~~Aug 2, 1996~Yes~OTC~SANOFI AVENTIS US LLC
NICOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~NICOTINE~AVEVA~7MG/24HR~A~074612~002
~~Jul 28, 2003~No~OTC~AVEVA DRUG DELIVERY SYSTEMS INC
3~~Oct 20, 1997~No~OTC~AVEVA DRUG DELIVERY SYSTEMS INC
1~~Oct 20, 1997~No~OTC~AVEVA DRUG DELIVERY SYSTEMS INC
NICOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~NICOTROL~MCNEIL CONS~15MG/16HR~N~020
536~001~~Jul 3, 1996~No~DISCN~MCNEIL CONSUMER HEALTHCARE
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~NITRO-DUR~MERCK SHARP DOHME~0.1
MG/HR~N~020145~001~AB1~Apr 4, 1995~Yes~RX~MERCK SHARP AND DOHME CORP
MG/HR~N~020145~003~~Apr 4, 1995~Yes~RX~MERCK SHARP AND DOHME CORP
MG/HR~N~020145~006~~Apr 4, 1995~Yes~RX~MERCK SHARP AND DOHME CORP
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~NITROGLYCERIN~HERCON PHARM~0.2M
G/HR~A~089884~001~AB2~Oct 30, 1998~No~RX~HERCON PHARMACEUTICAL LLC
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~NITROGLYCERIN~KREMERS URBAN PHA
RMS~0.2MG/HR~A~075115~001~~Aug 10, 2004~No~DISCN~KREMERS URBAN PHARMACEUTICALS I
NC
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~NITROGLYCERIN~KREMERS URBAN PHA
RMS~0.4MG/HR~A~075115~002~~Aug 10, 2004~No~DISCN~KREMERS URBAN PHARMACEUTICALS I
NC
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~NITROGLYCERIN~MYLAN TECHNOLOGIE
S~0.1MG/HR~A~074559~004~~Feb 6, 1998~Yes~RX~MYLAN TECHNOLOGIES INC
S~0.1MG/HR~A~074992~004~~Nov 12, 1999~No~DISCN~MYLAN TECHNOLOGIES INC
S~0.2MG/HR~A~074559~003~AB2~Aug 30, 1996~Yes~RX~MYLAN TECHNOLOGIES INC
ETHINYL ESTRADIOL; NORELGESTROMIN~FILM, EXTENDED RELEASE;TRANSDERMAL~ORTHO EVRA~
JANSSEN PHARMS~0.035MG/24HR;0.15MG/24HR~N~021180~001~~Nov 20, 2001~No~DISCN~JANS
SEN PHARMACEUTICALS INC

OXYBUTYNIN~FILM, EXTENDED RELEASE;TRANSDERMAL~OXYBUTYNIN~BARR LABS DIV TEVA~3.9M
G/24HR~A~090526~001~AB~Mar 4, 2014~No~RX~BARR LABORATORIES INC SUB TEVA PHARMACE
UTICALS USA
OXYBUTYNIN~FILM, EXTENDED RELEASE;TRANSDERMAL~OXYTROL~WATSON LABS (UTAH)~3.9MG/2
4HR~N~021351~002~AB~Feb 26, 2003~Yes~RX~WATSON LABORATORIES INC
OXYBUTYNIN~FILM, EXTENDED RELEASE;TRANSDERMAL~OXYTROL FOR WOMEN~BAYER HEALTHCARE
LLC~3.9MG/24HR~N~202211~001~~Jan 25, 2013~Yes~OTC~BAYER HEALTHCARE LLC
NICOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~PROSTEP~AVEVA~11MG/24HR~N~019983~003
~~Dec 23, 1998~No~DISCN~AVEVA DRUG DELIVERY SYSTEMS INC
NICOTINE~FILM, EXTENDED RELEASE;TRANSDERMAL~PROSTEP~AVEVA~22MG/24HR~N~019983~004
~~Dec 23, 1998~No~DISCN~AVEVA DRUG DELIVERY SYSTEMS INC
GRANISETRON~FILM, EXTENDED RELEASE;TRANSDERMAL~SANCUSO~PROSTRAKAN INC~3.1MG/24HR
~N~022198~001~~Sep 12, 2008~Yes~RX~PROSTRAKAN INC
SCOPOLAMINE~FILM, EXTENDED RELEASE;TRANSDERMAL~SCOPOLAMINE~PERRIGO R AND D~1MG/7
2HR~A~078830~001~AB~Jan 30, 2015~No~RX~PERRIGO R AND D CO
TESTOSTERONE~FILM, EXTENDED RELEASE;TRANSDERMAL~TESTODERM~ALZA~4MG/24HR~N~019762
~001~~Oct 12, 1993~No~DISCN~ALZA CORP
TESTOSTERONE~FILM, EXTENDED RELEASE;TRANSDERMAL~TESTODERM~ALZA~6MG/24HR~N~019762
~002~~Oct 12, 1993~No~DISCN~ALZA CORP
TESTOSTERONE~FILM, EXTENDED RELEASE;TRANSDERMAL~TESTODERM TTS~ALZA~5MG/24HR~N~02
0791~001~~Dec 18, 1997~No~DISCN~ALZA CORP
SCOPOLAMINE~FILM, EXTENDED RELEASE;TRANSDERMAL~TRANSDERM SCOP~NOVARTIS~1MG/72HR~
N~017874~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~NOVARTIS CONSUMER HEALTH IN
C
NITROGLYCERIN~FILM, EXTENDED RELEASE;TRANSDERMAL~TRANSDERM-NITRO~NOVARTIS~0.1MG/
HR~N~020144~001~~Feb 27, 1996~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~VIVELLE~NOVARTIS~0.025MG/24HR~N~020
323~005~~Aug 16, 2000~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
0323~001~~Oct 28, 1994~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
23~002~AB1~Oct 28, 1994~No~RX~NOVARTIS PHARMACEUTICALS CORP
323~003~~Oct 28, 1994~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
3~004~AB1~Oct 28, 1994~No~RX~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~VIVELLE-DOT~NOVARTIS~0.025MG/24HR~N
~020538~009~AB1~May 3, 2002~No~RX~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~VIVELLE-DOT~NOVARTIS~0.0375MG/24HR~
N~020538~005~AB1~Jan 8, 1999~No~RX~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~VIVELLE-DOT~NOVARTIS~0.05MG/24HR~N~
020538~006~AB1~Jan 8, 1999~No~RX~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~VIVELLE-DOT~NOVARTIS~0.075MG/24HR~N
~020538~007~AB1~Jan 8, 1999~No~RX~NOVARTIS PHARMACEUTICALS CORP
ESTRADIOL~FILM, EXTENDED RELEASE;TRANSDERMAL~VIVELLE-DOT~NOVARTIS~0.1MG/24HR~N~0
20538~008~AB1~Jan 8, 1999~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
ETHINYL ESTRADIOL; NORELGESTROMIN~FILM, EXTENDED RELEASE;TRANSDERMAL~XULANE~MYLA
N TECHNOLOGIES~0.035MG/24HR;0.15MG/24HR~A~200910~001~AB~Apr 16, 2014~Yes~RX~MYLA
N TECHNOLOGIES
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE~FILM;BUCCAL~BUNAVAIL~BIODELI
VERY SCI INTL~EQ 2.1MG BASE;EQ 0.3MG BASE~N~205637~001~~Jun 6, 2014~No~RX~BIODEL
IVERY SCIENCES INTERNATIONAL INC

VERY SCI INTL~EQ 4.2MG BASE;EQ 0.7MG BASE~N~205637~002~~Jun 6, 2014~No~RX~BIODEL
IVERY SCIENCES INTERNATIONAL INC
VERY SCI INTL~EQ 6.3MG BASE;EQ 1MG BASE~N~205637~003~~Jun 6, 2014~Yes~RX~BIODELI
VERY SCIENCES INTERNATIONAL INC
FENTANYL CITRATE~FILM;BUCCAL~ONSOLIS~MEDA PHARMS~EQ 0.2MG BASE~N~022266~001~~Jul
16, 2009~No~DISCN~MEDA PHARMACEUTICALS INC
KETOPROFEN~FILM;ORAL~NEXCEDE~NOVARTIS~12.5MG~N~022470~001~~Nov 25, 2009~No~DISCN
~NOVARTIS CONSUMER HEALTH INC
ONDANSETRON~FILM;ORAL~ZUPLENZ~GALENA BIOPHARMA INC~4MG~N~022524~001~~Jul 2, 2010
~No~RX~GALENA BIOPHARMA INC
ONDANSETRON~FILM;ORAL~ZUPLENZ~GALENA BIOPHARMA INC~8MG~N~022524~002~~Jul 2, 2010
~Yes~RX~GALENA BIOPHARMA INC
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE~FILM;SUBLINGUAL~SUBOXONE~REC
KITT BENCKISER~EQ 2MG BASE;EQ 0.5MG BASE~N~022410~001~~Aug 30, 2010~No~RX~RECKIT
T BENCKISER PHARMACEUTICALS INC
KITT BENCKISER~EQ 4MG BASE;EQ 1MG BASE~N~022410~003~~Aug 10, 2012~No~RX~RECKITT
BENCKISER PHARMACEUTICALS INC
KITT BENCKISER~EQ 8MG BASE;EQ 2MG BASE~N~022410~002~~Aug 30, 2010~No~RX~RECKITT
BENCKISER PHARMACEUTICALS INC
KITT BENCKISER~EQ 12MG BASE;EQ 3MG BASE~N~022410~004~~Aug 10, 2012~Yes~RX~RECKIT
T BENCKISER PHARMACEUTICALS INC
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SOD
IUM CHLORIDE~FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL~HALFLYTELY~BRAINTREE~5MG
,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM~N~021551~003~~Jul 16, 2010~No~DIS
CN~BRAINTREE LABORATORIES INC
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SOD
IUM CHLORIDE~FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL~PEG-3350, SODIUM CHLORID
E, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL~NOVEL LABS INC~5MG,N/A;N
/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM~A~202217~001~~Aug 20, 2014~Yes~RX~NOVEL
LABORATORIES INC
CITRIC ACID; UREA C-13~FOR SOLUTION, TABLET, FOR SOLUTION;ORAL~IDKIT:HP~EXALENZ
BIOSCIENCE~N/A,4GM;75MG,N/A~N~021314~001~~Dec 17, 2002~Yes~RX~EXALENZ BIOSCIENCE
LTD
AZTREONAM~FOR SOLUTION;INHALATION~CAYSTON~GILEAD~75MG/VIAL~N~050814~001~~Feb 22,
2010~Yes~RX~GILEAD SCIENCES INC
PENTAMIDINE ISETHIONATE~FOR SOLUTION;INHALATION~NEBUPENT~FRESENIUS KABI USA~300M
G/VIAL~N~019887~001~~Jun 15, 1989~Yes~RX~FRESENIUS KABI USA LLC
PENTAMIDINE ISETHIONATE~FOR SOLUTION;INHALATION~NEBUPENT~FRESENIUS KABI USA~600M
G/VIAL~N~019887~002~~Mar 22, 1996~No~DISCN~FRESENIUS KABI USA LLC
METHACHOLINE CHLORIDE~FOR SOLUTION;INHALATION~PROVOCHOLINE~METHAPHARM~100MG/VIAL
~N~019193~001~~Oct 31, 1986~Yes~RX~METHAPHARM INC
RIBAVIRIN~FOR SOLUTION;INHALATION~VIRAZOLE~VALEANT PHARM INTL~6GM/VIAL~N~018859~
001~~Dec 31, 1985~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
SECRETIN SYNTHETIC HUMAN~FOR SOLUTION;INTRAVENOUS~CHIRHOSTIM~CHIRHOCLIN~16MCG/VI
AL~N~021256~001~~Apr 9, 2004~Yes~RX~CHIRHOCLIN INC
SECRETIN SYNTHETIC HUMAN~FOR SOLUTION;INTRAVENOUS~CHIRHOSTIM~CHIRHOCLIN~40MCG/VI
AL~N~021256~002~~Jun 21, 2007~No~RX~CHIRHOCLIN INC

NESIRITIDE RECOMBINANT~FOR SOLUTION;INTRAVENOUS~NATRECOR~SCIOS LLC~1.5MG/VIAL~N~
020920~001~~Aug 10, 2001~Yes~RX~SCIOS LLC
SECRETIN SYNTHETIC PORCINE~FOR SOLUTION;INTRAVENOUS~SECREFLO~CHIRHOCLIN~16MCG/VI
AL~N~021136~001~~Apr 4, 2002~No~DISCN~CHIRHOCLIN INC
HEXAMINOLEVULINATE HYDROCHLORIDE~FOR SOLUTION;INTRAVESICAL~CYSVIEW KIT~PHOTOCURE
ASA~100MG/VIAL~N~022555~001~~May 28, 2010~Yes~RX~PHOTOCURE ASA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID;
NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SO
DIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E~FOR SOLUTION;IV (INFUSION)~M.
V.I. PEDIATRIC~HOSPIRA~80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0
.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIA
L;7MG/VIAL~N~018920~001~~Sep 21, 2000~Yes~RX~HOSPIRA INC
CHYMOTRYPSIN~FOR SOLUTION;OPHTHALMIC~ALPHA CHYMAR~SOLA BARNES HIND~750 UNITS/VIA
L~N~011837~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLA BARNES HIND
CHYMOTRYPSIN~FOR SOLUTION;OPHTHALMIC~CATARASE~CIBA~300 UNITS/VIAL~N~016938~001~~
Approved Prior to Jan 1, 1982~No~DISCN~CIBA VISION CORP DIV NOVARTIS CO
CHYMOTRYPSIN~FOR SOLUTION;OPHTHALMIC~CATARASE~NOVARTIS~150 UNITS/VIAL~N~018121~0
CHLORAMPHENICOL~FOR SOLUTION;OPHTHALMIC~CHLOROMYCETIN~PARKEDALE~25MG/VIAL~N~0501
43~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
ACETYLCHOLINE CHLORIDE~FOR SOLUTION;OPHTHALMIC~MIOCHOL~NOVARTIS~20MG/VIAL~N~0162
ACETYLCHOLINE CHLORIDE~FOR SOLUTION;OPHTHALMIC~MIOCHOL-E~BAUSCH AND LOMB~20MG/VI
AL~N~020213~001~~Sep 22, 1993~Yes~RX~BAUSCH AND LOMB INC
ECHOTHIOPHATE IODIDE~FOR SOLUTION;OPHTHALMIC~PHOSPHOLINE IODIDE~WYETH PHARMS INC
~0.03%~N~011963~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICAL
S INC
S INC
~0.125%~N~011963~001~~Approved Prior to Jan 1, 1982~Yes~RX~WYETH PHARMACEUTICALS
INC
S INC
CHYMOTRYPSIN~FOR SOLUTION;OPHTHALMIC~ZOLYSE~ALCON~750 UNITS/VIAL~N~011903~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
OXACILLIN SODIUM~FOR SOLUTION;ORAL~BACTOCILL~GLAXOSMITHKLINE~EQ 250MG BASE/5ML~A
~062321~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~BEEPEN-VK~GLAXOSMITHKLINE~EQ 125MG BASE
/5ML~A~062270~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~BEEPEN-VK~GLAXOSMITHKLINE~EQ 250MG BASE
/5ML~A~062270~002~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~BETAPEN-VK~APOTHECON~EQ 125MG BASE/5ML~
A~061149~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL M
YERS SQUIBB
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~BETAPEN-VK~APOTHECON~EQ 250MG BASE/5ML~
YERS SQUIBB
UREA C-13~FOR SOLUTION;ORAL~BREATHTEK UBT FOR H-PYLORI~OTSUKA AMERICA~EQ 75MG/PO
UCH~N~020586~002~~May 10, 2001~No~DISCN~OTSUKA AMERICA PHARMACEUTICALS INC
DICLOFENAC POTASSIUM~FOR SOLUTION;ORAL~CAMBIA~DEPOMED INC~50MG~N~022165~001~~Jun
17, 2009~Yes~RX~DEPOMED INC
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORID
E; SODIUM SULFATE~FOR SOLUTION;ORAL~CLENZ-LYTE~PADDOCK LLC~236GM/BOT;2.97GM/BOT;
6.74GM/BOT;5.86GM/BOT;22.74GM/BOT~A~090769~001~~Jun 7, 2010~No~DISCN~PADDOCK LAB
ORATORIES LLC
CLINDAMYCIN PALMITATE HYDROCHLORIDE~FOR SOLUTION;ORAL~CLEOCIN~PHARMACIA AND UPJO
HN~EQ 75MG BASE/5ML~A~061827~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMAC

IA AND UPJOHN CO
CLINDAMYCIN PALMITATE HYDROCHLORIDE~FOR SOLUTION;ORAL~CLEOCIN~PHARMACIA AND UPJO
HN~EQ 75MG BASE/5ML~A~062644~001~AA~Apr 7, 1986~Yes~RX~PHARMACIA AND UPJOHN CO
CLINDAMYCIN PALMITATE HYDROCHLORIDE~FOR SOLUTION;ORAL~CLINDAMYCIN PALMITATE HYDR
OCHLORIDE~AMNEAL PHARMS~EQ 75MG BASE/5ML~A~203513~001~AA~Mar 13, 2014~No~RX~AMNE
AL PHARMACEUTICALS
OCHLORIDE~AUROBINDO PHARMA LTD~EQ 75MG BASE/5ML~A~202409~001~AA~Apr 30, 2013~No~
RX~AUROBINDO PHARMA LTD
OCHLORIDE~LYNE~EQ 75MG BASE/5ML~A~201821~001~AA~Aug 28, 2012~No~RX~LYNE LABORATO
RIES INC
OCHLORIDE~PADDOCK LABS~EQ 75MG BASE/5ML~A~090902~001~AA~Jul 7, 2010~No~RX~PADDOC
K LABORATORIES INC
CLOXACILLIN SODIUM~FOR SOLUTION;ORAL~CLOXACILLIN SODIUM~TEVA~EQ 125MG BASE/5ML~A
~062268~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
CLOXACILLIN SODIUM~FOR SOLUTION;ORAL~CLOXACILLIN SODIUM~TEVA~EQ 125MG BASE/5ML~A
~062978~001~~Apr 6, 1989~No~DISCN~TEVA PHARMACEUTICALS USA INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~COLYTE~MEDA PHARMS~120GM/PACKET;1.
49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET~N~018983~005~~Oct 26, 198
4~No~DISCN~MEDA PHARMACEUTICALS INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~COLYTE~MEDA PHARMS~227.1GM/PACKET;
2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET~N~018983~004~~Oct 26, 19
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~COLYTE~MEDA PHARMS~227.1GM/BOT;2.8
2GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT~N~018983~010~~Jan 31, 1989~No~RX~MEDA P
HARMACEUTICALS INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~COLYTE~MEDA PHARMS~240GM/BOT;2.98G
M/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT~N~018983~007~~Jun 12, 1987~No~DISCN~MEDA
PHARMACEUTICALS INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~COLYTE~MEDA PHARMS~360GM/PACKET;4.
47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET~N~018983~006~~Oct 26, 19
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~COLYTE WITH FLAVOR PACKS~MEDA PHAR
MS~240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT~N~018983~012~~Oct 8, 1
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~COLYTE-FLAVORED~MEDA PHARMS~227.1G
M/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT~N~018983~008~~Nov 14, 1991~No~
DISCN~MEDA PHARMACEUTICALS INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~COLYTE-FLAVORED~MEDA PHARMS~240GM/
BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT~N~018983~009~~Nov 14, 1991~No~D
ISCN~MEDA PHARMACEUTICALS INC
BETAINE HYDROCHLORIDE~FOR SOLUTION;ORAL~CYSTADANE~RARE DIS THERAP~1GM/SCOOPFUL~N
~020576~001~~Oct 25, 1996~Yes~RX~RARE DISEASE THERAPEUTICS INC
DIDANOSINE~FOR SOLUTION;ORAL~DIDANOSINE~AUROBINDO PHARMA~10MG/ML~A~078112~001~AA
~Mar 8, 2007~No~RX~AUROBINDO PHARMA LTD
ENALAPRIL MALEATE~FOR SOLUTION;ORAL~EPANED KIT~SILVERGATE PHARMS~1MG/ML~N~204308
~001~~Aug 13, 2013~Yes~RX~SILVERGATE PHARMACEUTICALS INC
FERRIC AMMONIUM CITRATE~FOR SOLUTION;ORAL~FERRISELTZ~OTSUKA~600MG/PACKET~N~02029
2~001~~Oct 14, 1997~No~DISCN~OTSUKA PHARMACEUTICAL CO LTD
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~GLYCOLAX~KREMERS URBAN PHARMS~17GM/SC

OOPFUL~A~076652~001~AA~Jul 2, 2004~No~RX~KREMERS URBAN PHARMACEUTICALS INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~GLYCOLAX~KREMERS URBAN PHARMS~17GM/PA
CKET~A~090600~001~~Oct 6, 2009~No~OTC~KREMERS URBAN PHARMACEUTICALS INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~GLYCOLAX~KREMERS URBAN PHARMS~17GM/SC
OOPFUL~A~090600~002~~Oct 6, 2009~No~OTC~KREMERS URBAN PHARMACEUTICALS INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~GOLYTELY~BRAINTREE~227.1GM/PACKET;
2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET~N~019011~002~~Jun 2, 199
2~Yes~RX~BRAINTREE LABORATORIES INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~GOLYTELY~BRAINTREE~236GM/BOT;2.97G
M/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT~N~019011~001~AA~Jul 13, 1984~Yes~RX~BRAI
NTREE LABORATORIES INC
UREA C-13~FOR SOLUTION;ORAL~HELICOSOL~METABOLIC SOLUTIONS~125MG/VIAL~N~021092~00
1~~Dec 17, 1999~No~DISCN~METABOLIC SOLUTIONS INC
LACTULOSE~FOR SOLUTION;ORAL~LACTULOSE~CUMBERLAND PHARMS~10GM/PACKET~A~074712~001
~~Dec 10, 1997~Yes~RX~CUMBERLAND PHARMACEUTICALS INC
LACTULOSE~FOR SOLUTION;ORAL~LACTULOSE~CUMBERLAND PHARMS~20GM/PACKET~A~074712~002
~~Dec 10, 1997~Yes~RX~CUMBERLAND PHARMACEUTICALS INC
E~FOR SOLUTION;ORAL~LAX-LYTE WITH FLAVOR PACKS~PADDOCK LLC~420GM/BOT;1.48GM/BOT;
5.72GM/BOT;11.2GM/BOT~A~079232~001~AA~Feb 25, 2010~No~RX~PADDOCK LABORATORIES LL
C
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~LEDERCILLIN VK~LEDERLE~EQ 125MG BASE/5M
L~A~060136~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV
AMERICAN CYANAMID CO
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~LEDERCILLIN VK~LEDERLE~EQ 250MG BASE/5M
LEUCOVORIN CALCIUM~FOR SOLUTION;ORAL~LEUCOVORIN CALCIUM~HOSPIRA~EQ 60MG BASE/VIA
L~N~008107~003~~Jan 30, 1987~No~DISCN~HOSPIRA INC
MANGANESE CHLORIDE TETRAHYDRATE~FOR SOLUTION;ORAL~LUMENHANCE~BRACCO~3.49MG/GM~N~
020686~001~~Dec 19, 1997~No~DISCN~BRACCO DIAGNOSTICS INC
UREA C-13~FOR SOLUTION;ORAL~MERETEK UBT KIT (W/ PRANACTIN)~OTSUKA AMERICA~125MG/
VIAL~N~020586~001~~Sep 17, 1996~No~DISCN~OTSUKA AMERICA PHARMACEUTICALS INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~MIRALAX~SCHERING PLOUGH~17GM/SCOOPFUL
~N~022015~001~~Oct 6, 2006~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; S
ODIUM CHLORIDE; SODIUM SULFATE~FOR SOLUTION;ORAL~MOVIPREP~NOVEL LABS INC~4.7GM;1
00GM;1.015GM;5.9GM;2.691GM;7.5GM~A~090145~001~~Jan 25, 2012~No~DISCN~NOVEL LABOR
ATORIES INC
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; S
ODIUM CHLORIDE; SODIUM SULFATE~FOR SOLUTION;ORAL~MOVIPREP~SALIX PHARMS~4.7GM;100
GM;1.015GM;5.9GM;2.691GM;7.5GM~N~021881~001~~Aug 2, 2006~Yes~RX~SALIX PHARMACEUT
ICALS INC
E~FOR SOLUTION;ORAL~NULYTELY~BRAINTREE~420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BO
T~N~019797~001~AA~Apr 22, 1991~Yes~RX~BRAINTREE LABORATORIES INC
E~FOR SOLUTION;ORAL~NULYTELY-FLAVORED~BRAINTREE~420GM/BOT;1.48GM/BOT;5.72GM/BOT;
11.2GM/BOT~N~019797~002~AA~Nov 18, 1994~Yes~RX~BRAINTREE LABORATORIES INC
GLUTAMINE~FOR SOLUTION;ORAL~NUTRESTORE~EMMAUS MEDCL~5GM/PACKET~N~021667~001~~Jun
10, 2004~Yes~RX~EMMAUS MEDICAL INC
OXACILLIN SODIUM~FOR SOLUTION;ORAL~OXACILLIN SODIUM~APOTHECON~EQ 250MG BASE/5ML~
YERS SQUIBB
OXACILLIN SODIUM~FOR SOLUTION;ORAL~OXACILLIN SODIUM~TEVA~EQ 250MG BASE/5ML~A~062
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~PEG 3350 AND ELECTROLYTES~MYLAN~23

6GM;2.97GM;6.74GM;5.86GM;22.74GM~A~090928~001~AA~Jan 28, 2010~No~RX~MYLAN PHARMA
CEUTICALS INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~PEG 3350 AND ELECTROLYTES~NOVEL LA
BS INC~236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT~A~090231~001~AA~Ju
n 1, 2009~No~RX~NOVEL LABORATORIES INC
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~PEG 3350 AND ELECTROLYTES~NOVEL LA
BS INC~240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT~A~090186~001~AA~Ju
n 1, 2009~No~RX~NOVEL LABORATORIES INC
E~FOR SOLUTION;ORAL~PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORI
DE~MYLAN~420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT~A~090409~001~AA~Apr 2, 2010~
E~FOR SOLUTION;ORAL~PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORI
DE~NOVEL LABS INC~420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT~A~090019~001~AA~May
27, 2009~No~RX~NOVEL LABORATORIES INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PEN-VEE K~WYETH AYERST~EQ 125MG BASE/5M
L~A~060007~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PEN-VEE K~WYETH AYERST~EQ 250MG BASE/5M
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENAPAR-VK~PARKE DAVIS~EQ 125MG BASE/5M
L~A~062002~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LA
MBERT CO
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENAPAR-VK~PARKE DAVIS~EQ 250MG BASE/5M
L~A~062002~002~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LA
MBERT CO
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN~TEVA~200,000 UNITS/5ML~A~060
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN~TEVA~400,000 UNITS/5ML~A~060
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN G POTASSIUM~MYLAN~200,000 UN
ITS/5ML~A~060752~003~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICA
LS INC
LS INC
LS INC
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN G POTASSIUM~PUREPAC PHARM~25
0,000 UNITS/5ML~A~061740~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHA
RMACEUTICAL CO
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN G POTASSIUM~PUREPAC PHARM~40
0,000 UNITS/5ML~A~061740~002~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHA
RMACEUTICAL CO
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN V POTASSIUM~AM ANTIBIOTICS~E
Q 125MG BASE/5ML~A~061529~001~~Approved Prior to Jan 1, 1982~No~DISCN~AMERICAN A
NTIBIOTICS LLC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN V POTASSIUM~AM ANTIBIOTICS~E
Q 250MG BASE/5ML~A~061529~002~~Approved Prior to Jan 1, 1982~No~DISCN~AMERICAN A
NTIBIOTICS LLC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN V POTASSIUM~DAVA PHARMS INC~
EQ 125MG BASE/5ML~A~062981~001~AA~Feb 10, 1989~No~RX~DAVA PHARMACEUTICALS INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN V POTASSIUM~DAVA PHARMS INC~
EQ 250MG BASE/5ML~A~062981~002~AA~Feb 10, 1989~No~RX~DAVA PHARMACEUTICALS INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN V POTASSIUM~MYLAN~EQ 125MG B
ASE/5ML~A~061624~002~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICA
LS INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN V POTASSIUM~MYLAN~EQ 250MG B
ASE/5ML~A~061624~001~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICA
LS INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN V POTASSIUM~PUREPAC PHARM~EQ
125MG BASE/5ML~A~061758~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHA
RMACEUTICAL CO
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN V POTASSIUM~PUREPAC PHARM~EQ
250MG BASE/5ML~A~061758~002~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHA
RMACEUTICAL CO
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN-2~TEVA~250,000 UNITS/5ML~A~0
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN-VK~TEVA~EQ 125MG BASE/5ML~A~
060456~001~AA~Approved Prior to Jan 1, 1982~No~RX~TEVA PHARMACEUTICALS USA INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PENICILLIN-VK~TEVA~EQ 250MG BASE/5ML~A~
060456~002~AA~Approved Prior to Jan 1, 1982~Yes~RX~TEVA PHARMACEUTICALS USA INC
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PENTIDS '200'~APOTHECON~200,000 UNITS/5
ML~A~062149~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL MY
ERS SQUIBB CO
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PENTIDS '400'~APOTHECON~400,000 UNITS/5
ERS SQUIBB CO
PENICILLIN G POTASSIUM~FOR SOLUTION;ORAL~PFIZERPEN G~PFIZER~400,000 UNITS/5ML~A~
060587~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZE
R INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PFIZERPEN VK~PFIZER~EQ 125MG BASE/5ML~A
ER INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~PFIZERPEN VK~PFIZER~EQ 250MG BASE/5ML~A
ER INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~BRECKENRIDGE
PHARM~17GM/SCOOPFUL~A~077736~001~AA~May 26, 2006~No~RX~BRECKENRIDGE PHARMACEUTI
CAL INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~MYLAN~17GM/P
ACKET~A~078915~001~~Oct 6, 2009~No~OTC~MYLAN PHARMACEUTICALS INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~MYLAN~17GM/S
COOPFUL~A~078915~002~~Oct 6, 2009~No~OTC~MYLAN PHARMACEUTICALS INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~NEXGEN PHARM
A~17GM/SCOOPFUL~A~090812~001~~Oct 7, 2009~No~OTC~NEXGEN PHARMA INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~NEXGEN PHARM
A INC~17GM/SCOOPFUL~A~077706~001~AA~Sep 27, 2006~No~RX~NEXGEN PHARMA INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~NOVEL LABS I
NC~17GM/SCOOPFUL~A~091077~001~~Oct 6, 2009~No~OTC~NOVEL LABORATORIES INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~PADDOCK LLC~
17GM/SCOOPFUL~A~077893~001~AA~May 26, 2006~No~RX~PADDOCK LABORATORIES LLC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~PADDOCK LLC~
17GM/SCOOPFUL~A~090567~001~~Oct 15, 2009~No~DISCN~PADDOCK LABORATORIES LLC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~PAR PHARM~17
GM/SCOOPFUL~A~079214~001~~Jan 31, 2013~No~OTC~PAR PHARMACEUTICAL INC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~PERRIGO R AN
D D~17GM/PACKET~A~090685~001~~Oct 6, 2009~No~OTC~PERRIGO R AND D CO
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~PERRIGO R AN
D D~17GM/SCOOPFUL~A~090685~002~~Oct 6, 2009~No~OTC~PERRIGO R AND D CO
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~RARITAN PHAR
MS INC~17GM/SCOOPFUL~A~202071~001~~Dec 28, 2012~No~OTC~RARITAN PHARMACEUTICALS I
NC
POLYETHYLENE GLYCOL 3350~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350~TEVA PHARMS~
17GM/SCOOPFUL~A~077445~001~~May 4, 2006~No~DISCN~TEVA PHARMACEUTICALS USA
E; SODIUM SULFATE ANHYDROUS~FOR SOLUTION;ORAL~POLYETHYLENE GLYCOL 3350 AND ELECT

ROLYTES~PADDOCK LLC~240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT~A~090
712~001~~Feb 25, 2010~No~DISCN~PADDOCK LABORATORIES LLC
POTASSIUM CITRATE~FOR SOLUTION;ORAL~POTASSIUM CITRATE~UT SW MEDCTR~10MEQ/PACKET
for safety or efficacy reasons**~N~019647~002~~Oct 13, 1988~No~DISCN~UT SOUTHWES
TERN MEDCTR
POTASSIUM CITRATE~FOR SOLUTION;ORAL~POTASSIUM CITRATE~UT SW MEDCTR~20MEQ/PACKET
for safety or efficacy reasons**~N~019647~001~~Oct 13, 1988~No~DISCN~UT SOUTHWES
TERN MEDCTR
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE~FOR SOLUTION;ORAL~PREPOPIK~FERR
ING PHARMS AS~12GM/PACKET;3.5GM/PACKET;10MG/PACKET~N~202535~001~~Jul 16, 2012~Ye
s~RX~FERRING PHARMACEUTICALS AS
OXACILLIN SODIUM~FOR SOLUTION;ORAL~PROSTAPHLIN~APOTHECON~EQ 250MG BASE/5ML~N~050
SQUIBB
UREA C-13~FOR SOLUTION;ORAL~PYLORI-CHEK BREATH TEST~DXS DEVICES~100MG/VIAL~N~020
900~001~~Feb 4, 1999~No~DISCN~DIAGNOSTICS AND DEVICES INC
VIGABATRIN~FOR SOLUTION;ORAL~SABRIL~LUNDBECK LLC~500MG/PACKET~N~022006~001~~Aug
21, 2009~Yes~RX~LUNDBECK LLC
STAVUDINE~FOR SOLUTION;ORAL~STAVUDINE~AUROBINDO PHARMA~1MG/ML~A~077774~001~AA~De
c 29, 2008~No~RX~AUROBINDO PHARMA LTD
STAVUDINE~FOR SOLUTION;ORAL~STAVUDINE~CIPLA LTD~1MG/ML~A~078030~001~AA~Mar 20, 2
009~No~RX~CIPLA LTD
CLOXACILLIN SODIUM~FOR SOLUTION;ORAL~TEGOPEN~APOTHECON~EQ 125MG BASE/5ML~A~06145
3~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQ
UIBB
CLOXACILLIN SODIUM~FOR SOLUTION;ORAL~TEGOPEN~APOTHECON~EQ 125MG BASE/5ML~N~05019
UIBB
E~FOR SOLUTION;ORAL~TRILYTE~MEDA PHARMS~420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/B
OT~A~076491~001~AA~Feb 5, 2004~No~RX~MEDA PHARMACEUTICALS INC
NAFCILLIN SODIUM~FOR SOLUTION;ORAL~UNIPEN~WYETH AYERST~EQ 250MG BASE/5ML~N~05019
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~V-CILLIN K~LILLY~EQ 125MG BASE/5ML~A~06
0004~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~V-CILLIN K~LILLY~EQ 250MG BASE/5ML~A~06
VALGANCICLOVIR HYDROCHLORIDE~FOR SOLUTION;ORAL~VALCYTE~HOFFMANN LA ROCHE~50MG/ML
~N~022257~001~~Aug 28, 2009~Yes~RX~HOFFMANN LA ROCHE INC
VANCOMYCIN HYDROCHLORIDE~FOR SOLUTION;ORAL~VANCOCIN HYDROCHLORIDE~ANI PHARMS INC
~EQ 250MG BASE/5ML~A~061667~002~~Jul 13, 1983~No~DISCN~ANI PHARMACEUTICALS INC
VANCOMYCIN HYDROCHLORIDE~FOR SOLUTION;ORAL~VANCOCIN HYDROCHLORIDE~ANI PHARMS INC
~EQ 500MG BASE/6ML~A~061667~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANI PHAR
MACEUTICALS INC
VANCOMYCIN HYDROCHLORIDE~FOR SOLUTION;ORAL~VANCOLED~LEDERLE~EQ 250MG BASE/5ML~A~
063321~002~~Oct 15, 1993~No~DISCN~LEDERLE PARENTERALS INC
VANCOMYCIN HYDROCHLORIDE~FOR SOLUTION;ORAL~VANCOLED~LEDERLE~EQ 500MG BASE/6ML~A~
063321~003~~Oct 15, 1993~No~DISCN~LEDERLE PARENTERALS INC
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~VEETIDS~APOTHECON~EQ 125MG BASE/5ML~A~0
61410~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYER
S SQUIBB
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~VEETIDS~APOTHECON~EQ 250MG BASE/5ML~A~0
S SQUIBB
PENICILLIN V POTASSIUM~FOR SOLUTION;ORAL~VEETIDS '125'~APOTHECON~EQ 125MG BASE/5
ERS SQUIBB CO

ERS SQUIBB CO
ERS SQUIBB CO
ERS SQUIBB CO
DIDANOSINE~FOR SOLUTION;ORAL~VIDEX~BRISTOL MYERS SQUIBB~10MG/ML~N~020156~001~AA~
Oct 9, 1991~Yes~RX~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
DIDANOSINE~FOR SOLUTION;ORAL~VIDEX~BRISTOL MYERS SQUIBB~100MG/PACKET~N~020155~00
3~~Oct 9, 1991~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUT
E
E
E
E
STAVUDINE~FOR SOLUTION;ORAL~ZERIT~BRISTOL MYERS SQUIBB~1MG/ML~N~020413~001~AA~Se
p 6, 1996~Yes~RX~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
DIATRIZOATE SODIUM~FOR SOLUTION;ORAL, RECTAL~HYPAQUE~GE HEALTHCARE~100%~N~011386
~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
GLATIRAMER ACETATE~FOR SOLUTION;SUBCUTANEOUS~COPAXONE~TEVA PHARMS USA~20MG/VIAL~
N~020622~001~~Dec 20, 1996~No~DISCN~TEVA PHARMACEUTICALS USA
MAFENIDE ACETATE~FOR SOLUTION;TOPICAL~MAFENIDE ACETATE~PAR FORM~5%~A~201511~001~
AT~Feb 12, 2013~No~RX~PAR FORMULATIONS PRIVATE LTD
MITOMYCIN~FOR SOLUTION;TOPICAL~MITOSOL~MOBIUS THERAP~0.2MG/VIAL~N~022572~001~~Fe
b 7, 2012~Yes~RX~MOBIUS THERAPEUTICS LLC
MAFENIDE ACETATE~FOR SOLUTION;TOPICAL~SULFAMYLON~MYLAN INSTITUTIONAL~5%~N~019832
~003~AT~Jun 5, 1998~Yes~RX~MYLAN INSTITUTIONAL INC
TETRACYCLINE HYDROCHLORIDE~FOR SOLUTION;TOPICAL~TOPICYCLINE~SHIRE~2.2MG/ML~N~050
493~001~~Approved Prior to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
ESOMEPRAZOLE MAGNESIUM~FOR SUSPENSION, DELAYED RELEASE;ORAL~NEXIUM~ASTRAZENECA P
HARMS~EQ 2.5MG BASE/PACKET~N~021957~003~~Dec 15, 2011~No~RX~ASTRAZENECA PHARMACE
UTICALS LP
HARMS~EQ 5MG BASE/PACKET~N~021957~004~~Dec 15, 2011~No~RX~ASTRAZENECA PHARMACEUT
ICALS LP
HARMS~EQ 10MG BASE/PACKET~N~022101~001~~Feb 27, 2008~No~RX~ASTRAZENECA PHARMACEU
TICALS LP
HARMS~EQ 20MG BASE/PACKET~N~021957~001~~Oct 20, 2006~No~RX~ASTRAZENECA PHARMACEU
TICALS LP
HARMS~EQ 40MG BASE/PACKET~N~021957~002~~Oct 20, 2006~Yes~RX~ASTRAZENECA PHARMACE
UTICALS LP
LANSOPRAZOLE~FOR SUSPENSION, DELAYED RELEASE;ORAL~PREVACID~TAKEDA PHARMS NA~15MG
/PACKET~N~021281~001~~May 3, 2001~No~DISCN~TAKEDA PHARMACEUTICALS NORTH AMERICA
INC
LANSOPRAZOLE~FOR SUSPENSION, DELAYED RELEASE;ORAL~PREVACID~TAKEDA PHARMS NA~30MG
/PACKET~N~021281~002~~May 3, 2001~No~DISCN~TAKEDA PHARMACEUTICALS NORTH AMERICA
INC
OMEPRAZOLE MAGNESIUM~FOR SUSPENSION, DELAYED RELEASE;ORAL~PRILOSEC~ASTRAZENECA P
HARMS~EQ 2.5MG BASE/PACKET~N~022056~001~~Mar 20, 2008~No~RX~ASTRAZENECA PHARMACE
UTICALS LP
OMEPRAZOLE MAGNESIUM~FOR SUSPENSION, DELAYED RELEASE;ORAL~PRILOSEC~ASTRAZENECA P
HARMS~EQ 10MG BASE/PACKET~N~022056~002~~Mar 20, 2008~Yes~RX~ASTRAZENECA PHARMACE
UTICALS LP
PANTOPRAZOLE SODIUM~FOR SUSPENSION, DELAYED RELEASE;ORAL~PROTONIX~WYETH PHARMS I
NC~EQ 40MG BASE~N~022020~001~~Nov 14, 2007~Yes~RX~WYETH PHARMACEUTICALS INC
ARIPIPRAZOLE~FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR~ABILIFY MAINTENA KIT
~OTSUKA PHARM CO LTD~300MG/VIAL~N~202971~001~~Feb 28, 2013~No~RX~OTSUKA PHARMACE
UTICAL CO LTD
~OTSUKA PHARM CO LTD~300MG~N~202971~003~~Sep 29, 2014~No~RX~OTSUKA PHARMACEUTICA
L CO LTD
~OTSUKA PHARM CO LTD~400MG/VIAL~N~202971~002~~Feb 28, 2013~Yes~RX~OTSUKA PHARMAC
EUTICAL CO LTD
~OTSUKA PHARM CO LTD~400MG~N~202971~004~~Sep 29, 2014~No~RX~OTSUKA PHARMACEUTICA
L CO LTD
NALTREXONE~FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR~VIVITROL~ALKERMES~380M
G/VIAL~N~021897~001~~Apr 13, 2006~Yes~RX~ALKERMES INC
POTASSIUM CHLORIDE~FOR SUSPENSION, EXTENDED RELEASE;ORAL~MICRO-K LS~KV PHARM~20M
EQ/PACKET~N~019561~003~~Aug 26, 1988~No~DISCN~KV PHARMACEUTICAL CO
METHYLPHENIDATE HYDROCHLORIDE~FOR SUSPENSION, EXTENDED RELEASE;ORAL~QUILLIVANT X
R~NEXTWAVE PHARMS~5MG/ML~N~202100~001~~Sep 27, 2012~Yes~RX~NEXTWAVE PHARMACEUTIC
ALS INC
AZITHROMYCIN~FOR SUSPENSION, EXTENDED RELEASE;ORAL~ZMAX~PF PRISM CV~EQ 2GM BASE/
BOT~N~050797~001~~Jun 10, 2005~Yes~RX~PF PRISM CV
EXENATIDE SYNTHETIC~FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS~BYDUREON~ASTRA
ZENECA AB~2MG/VIAL~N~022200~001~~Jan 27, 2012~Yes~RX~ASTRAZENECA AB
AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE~FOR SUSPENSION, TABLET;ORAL~TROVA
N/ZITHROMAX COMPLIANCE PAK~PFIZER~EQ 1GM BASE,N/A;N/A,EQ 100MG BASE~N~050762~001
~~Dec 18, 1998~No~DISCN~PFIZER PHARMACEUTICALS INC
CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL~FOR SUSPENSION;INTRATRACHEAL~EXO
SURF NEONATAL~GLAXOSMITHKLINE~12MG/VIAL;108MG/VIAL;8MG/VIAL~N~020044~001~~Aug 2,
SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES~FOR SUSPENSION;INTRAVENOUS~LUMASON
~BRACCO~60.7MG/25MG~N~203684~001~~Oct 15, 2014~Yes~RX~BRACCO DIAGNOSTICS INC
DANTROLENE SODIUM~FOR SUSPENSION;INTRAVENOUS~RYANODEX~EAGLE PHARMS~250MG/VIAL~N~
205579~001~~Jul 22, 2014~No~RX~EAGLE PHARMACEUTICALS INC
PACLITAXEL~FOR SUSPENSION;IV (INFUSION)~ABRAXANE~ABRAXIS BIOSCIENCE~100MG/VIAL~N
~021660~001~~Jan 7, 2005~Yes~RX~ABRAXIS BIOSCIENCE LLC
CHLORAMPHENICOL; HYDROCORTISONE ACETATE~FOR SUSPENSION;OPHTHALMIC~CHLOROMYCETIN
HYDROCORTISONE~PARKEDALE~12.5MG/VIAL;25MG/VIAL~N~050202~001~~Approved Prior to J
an 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
NITAZOXANIDE~FOR SUSPENSION;ORAL~ALINIA~ROMARK~100MG/5ML~N~021498~001~~Nov 22, 2
002~Yes~RX~ROMARK LABORATORIES
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMCILL~PARKE DAVIS~EQ 125MG
BASE/5ML~A~062030~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV W
ARNER LAMBERT CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMCILL~PARKE DAVIS~EQ 250MG
BASE/5ML~A~062030~002~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV W
ARNER LAMBERT CO
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~AM ANTIBIOTICS~125MG/5ML~A~062059~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~AMERICAN ANTIBIOTICS LLC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~AM ANTIBIOTICS~250MG/5ML~A~062059~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~AMERICAN ANTIBIOTICS LLC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~AUROBINDO~200MG/5ML~A~065334~001~AB~
Dec 28, 2006~No~RX~AUROBINDO PHARMA LTD
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~AUROBINDO~400MG/5ML~A~065334~002~AB~
Dec 28, 2006~No~RX~AUROBINDO PHARMA LTD
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~AUROBINDO PHARMA LTD~125MG/5ML~A~204

AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~AUROBINDO PHARMA LTD~250MG/5ML~A~204
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~DAVA PHARMS INC~125MG/5ML~A~062927~0
01~AB~Nov 25, 1988~No~RX~DAVA PHARMACEUTICALS INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~DAVA PHARMS INC~250MG/5ML~A~062927~0
02~AB~Nov 25, 1988~No~RX~DAVA PHARMACEUTICALS INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~HIKMA~125MG/5ML~A~065322~002~AB~Jun
19, 2006~No~RX~HIKMA PHARMACEUTICALS
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~MYLAN~125MG/5ML~A~062090~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~MYLAN~250MG/5ML~A~062090~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~RANBAXY~200MG/5ML~A~065113~001~~Nov
29, 2002~No~DISCN~RANBAXY PHARMACEUTICALS INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~RANBAXY~400MG/5ML~A~065113~002~~Nov
29, 2002~No~DISCN~RANBAXY PHARMACEUTICALS INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~SANDOZ~125MG/5ML~A~065387~001~AB~Mar
26, 2007~No~RX~SANDOZ INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~TEVA~125MG/5ML~A~061931~001~AB~Appro
ved Prior to Jan 1, 1982~No~RX~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~TEVA~125MG/5ML~A~062946~001~~Nov 1,
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~TEVA~200MG/5ML~A~065119~001~AB~Dec 4
, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~TEVA~250MG/5ML~A~061931~002~AB~Appro
ved Prior to Jan 1, 1982~Yes~RX~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~TEVA~250MG/5ML~A~063001~001~~Jan 6,
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~TEVA~400MG/5ML~A~065119~002~AB~Dec 4
, 2002~Yes~RX~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN~WOCKHARDT~400MG/5ML~A~065319~002~AB~
Jun 18, 2007~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
AMOXICILLIN; CLAVULANATE POTASSIUM~FOR SUSPENSION;ORAL~AMOXICILLIN AND CLAVULANA
TE POTASSIUM~HIKMA PHARMS~200MG/5ML;EQ 28.5MG BASE/5ML~A~065191~002~AB~Jan 25, 2
TE POTASSIUM~HIKMA PHARMS~400MG/5ML;EQ 57MG BASE/5ML~A~065191~001~AB~Jan 25, 200
TE POTASSIUM~HIKMA PHARMS~600MG/5ML;EQ 42.9MG BASE/5ML~A~065373~001~AB~Nov 9, 20
TE POTASSIUM~RANBAXY~200MG/5ML;EQ 28.5MG BASE/5ML~A~065132~001~AB~Mar 19, 2003~N
o~RX~RANBAXY LABORATORIES LTD
TE POTASSIUM~RANBAXY~400MG/5ML;EQ 57MG BASE/5ML~A~065132~002~AB~Mar 19, 2003~No~

TE POTASSIUM~RANBAXY~600MG/5ML;EQ 42.9MG BASE/5ML~A~065207~002~AB~Jan 30, 2007~N
TE POTASSIUM~SANDOZ~200MG/5ML;EQ 28.5MG BASE/5ML~A~065066~001~AB~Jun 5, 2002~No~
RX~SANDOZ INC
TE POTASSIUM~SANDOZ~400MG/5ML;EQ 57MG BASE/5ML~A~065066~002~AB~Jun 5, 2002~No~RX
~SANDOZ INC
TE POTASSIUM~SANDOZ INC~200MG/5ML;EQ 28.5MG BASE/5ML~A~065098~001~AB~Dec 16, 200
2~No~RX~SANDOZ INC
TE POTASSIUM~SANDOZ INC~400MG/5ML;EQ 57MG BASE/5ML~A~065098~002~AB~Dec 16, 2002~
No~RX~SANDOZ INC
TE POTASSIUM~SANDOZ INC~600MG/5ML;EQ 42.9MG BASE/5ML~A~065358~001~AB~Aug 13, 200
7~No~RX~SANDOZ INC
TE POTASSIUM~TEVA~200MG/5ML;EQ 28.5MG BASE/5ML~A~065089~001~AB~May 25, 2004~No~R
TE POTASSIUM~TEVA~400MG/5ML;EQ 57MG BASE/5ML~A~065089~002~AB~May 25, 2004~Yes~RX
TE POTASSIUM~TEVA~600MG/5ML;EQ 42.9MG BASE/5ML~A~065162~001~AB~Mar 12, 2004~Yes~
TE POTASSIUM~WOCKHARDT~250MG/5ML;EQ 62.5MG BASE/5ML~A~065431~001~AB~Nov 25, 2008
~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
TE POTASSIUM~WOCKHARDT EU OPERATN~600MG/5ML;EQ 42.9MG BASE/5ML~A~065420~001~AB~D
ec 2, 2013~No~RX~WOCKHARDT EU OPERATIONS SWISS AG
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXICILLIN PEDIATRIC~TEVA~50MG/ML~A~061931~003~
AB~Dec 1, 1982~No~RX~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXIL~DR REDDYS LABS INC~50MG/ML~A~062226~005~A
B~Approved Prior to Jan 1, 1982~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXIL~DR REDDYS LABS INC~125MG/5ML~A~062226~001
~AB~Approved Prior to Jan 1, 1982~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXIL~DR REDDYS LABS INC~200MG/5ML~N~050760~001
~AB~Apr 15, 1999~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXIL~DR REDDYS LABS INC~250MG/5ML~A~062226~002
~AB~Approved Prior to Jan 1, 1982~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXIL~DR REDDYS LABS INC~400MG/5ML~N~050760~002
~AB~Apr 15, 1999~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXIL~GLAXOSMITHKLINE~50MG/ML~N~050460~005~~App
roved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXIL~GLAXOSMITHKLINE~125MG/5ML~N~050460~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
AMOXICILLIN~FOR SUSPENSION;ORAL~AMOXIL~GLAXOSMITHKLINE~250MG/5ML~N~050460~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~AM AN
TIBIOTICS~EQ 125MG BASE/5ML~A~061601~001~~Approved Prior to Jan 1, 1982~No~DISCN
~AMERICAN ANTIBIOTICS LLC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~AM AN
TIBIOTICS~EQ 250MG BASE/5ML~A~061601~002~~Approved Prior to Jan 1, 1982~No~DISCN
~AMERICAN ANTIBIOTICS LLC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~DAVA
PHARMS INC~EQ 125MG BASE/5ML~A~062982~001~~Feb 10, 1989~No~RX~DAVA PHARMACEUTICA
LS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~DAVA
PHARMS INC~EQ 250MG BASE/5ML~A~062982~002~~Feb 10, 1989~Yes~RX~DAVA PHARMACEUTIC
ALS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~MYLAN
~EQ 125MG BASE/5ML~A~061829~002~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PH
ARMACEUTICALS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~MYLAN
~EQ 250MG BASE/5ML~A~061829~001~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PH
ARMACEUTICALS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~PUREP
AC PHARM~EQ 125MG BASE/5ML~A~061980~001~~Approved Prior to Jan 1, 1982~No~DISCN~
PUREPAC PHARMACEUTICAL CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~PUREP
AC PHARM~EQ 250MG BASE/5ML~A~061980~002~~Approved Prior to Jan 1, 1982~No~DISCN~
PUREPAC PHARMACEUTICAL CO
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~TEVA~
EQ 125MG BASE/5ML~A~061370~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHAR
MACEUTICALS USA INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~AMPICILLIN TRIHYDRATE~TEVA~
EQ 250MG BASE/5ML~A~061370~002~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHAR
MACEUTICALS USA INC
CEPHRADINE~FOR SUSPENSION;ORAL~ANSPOR~GLAXOSMITHKLINE~125MG/5ML~A~061866~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CEPHRADINE~FOR SUSPENSION;ORAL~ANSPOR~GLAXOSMITHKLINE~250MG/5ML~A~061866~002~~Ap
AMOXICILLIN; CLAVULANATE POTASSIUM~FOR SUSPENSION;ORAL~AUGMENTIN '125'~DR REDDYS
LABS INC~125MG/5ML;EQ 31.25MG BASE/5ML~N~050575~001~AB~Aug 6, 1984~No~RX~DR RED
DYS LABORATORIES INC
LABS INC~200MG/5ML;EQ 28.5MG BASE/5ML~N~050725~001~AB~May 31, 1996~No~RX~DR RED
LABS INC~250MG/5ML;EQ 62.5MG BASE/5ML~N~050575~002~AB~Aug 6, 1984~Yes~RX~DR RED
LABS INC~400MG/5ML;EQ 57MG BASE/5ML~N~050725~002~AB~May 31, 1996~No~RX~DR REDDY
S LABORATORIES INC
AMOXICILLIN; CLAVULANATE POTASSIUM~FOR SUSPENSION;ORAL~AUGMENTIN ES-600~DR REDDY
S LABS INC~600MG/5ML;EQ 42.9MG BASE/5ML~N~050755~001~AB~Jun 22, 2001~No~RX~DR RE
DDYS LABORATORIES INC
AZITHROMYCIN~FOR SUSPENSION;ORAL~AZITHROMYCIN~PLIVA~EQ 100MG BASE/5ML~A~065246~0
02~AB~Jul 5, 2006~No~RX~PLIVA INC
AZITHROMYCIN~FOR SUSPENSION;ORAL~AZITHROMYCIN~PLIVA~EQ 200MG BASE/5ML~A~065246~0
AZITHROMYCIN~FOR SUSPENSION;ORAL~AZITHROMYCIN~SANDOZ~EQ 100MG BASE/5ML~A~065297~
001~~Sep 18, 2006~No~DISCN~SANDOZ INC
AZITHROMYCIN~FOR SUSPENSION;ORAL~AZITHROMYCIN~SANDOZ~EQ 200MG BASE/5ML~A~065297~
AZITHROMYCIN~FOR SUSPENSION;ORAL~AZITHROMYCIN~TEVA PHARMS~EQ 100MG BASE/5ML~A~06
AZITHROMYCIN~FOR SUSPENSION;ORAL~AZITHROMYCIN~TEVA PHARMS~EQ 200MG BASE/5ML~A~06
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~BANAN~SANKYO~EQ 50MG BASE/5ML~N~050688~
002~~Aug 7, 1992~No~DISCN~SANKYO USA CORP
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~BANAN~SANKYO~EQ 100MG BASE/5ML~N~050688
~001~~Aug 7, 1992~No~DISCN~SANKYO USA CORP
CLARITHROMYCIN~FOR SUSPENSION;ORAL~BIAXIN~ABBVIE~125MG/5ML~N~050698~001~AB~Dec 2
3, 1993~No~RX~ABBVIE INC
CLARITHROMYCIN~FOR SUSPENSION;ORAL~BIAXIN~ABBVIE~187MG/5ML~N~050698~003~~Sep 30,
CLARITHROMYCIN~FOR SUSPENSION;ORAL~BIAXIN~ABBVIE~250MG/5ML~N~050698~002~AB~Dec 2
3, 1993~Yes~RX~ABBVIE INC
CEFACLOR~FOR SUSPENSION;ORAL~CECLOR~LILLY~EQ 125MG BASE/5ML~N~050522~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
CEFACLOR~FOR SUSPENSION;ORAL~CECLOR~LILLY~EQ 250MG BASE/5ML~N~050522~002~~Approv
CEFTIBUTEN DIHYDRATE~FOR SUSPENSION;ORAL~CEDAX~PERNIX THERAP~EQ 90MG BASE/5ML~N~
050686~001~~Dec 20, 1995~Yes~RX~PERNIX THERAPEUTICS LLC
CEFTIBUTEN DIHYDRATE~FOR SUSPENSION;ORAL~CEDAX~PERNIX THERAP~EQ 180MG BASE/5ML~N
~050686~002~~Dec 20, 1995~Yes~RX~PERNIX THERAPEUTICS LLC
CEFACLOR~FOR SUSPENSION;ORAL~CEFACLOR~DAVA PHARMS INC~EQ 125MG BASE/5ML~A~064114
~001~~Apr 28, 1995~No~DISCN~DAVA PHARMACEUTICALS INC
CEFACLOR~FOR SUSPENSION;ORAL~CEFACLOR~FACTA FARMA~EQ 125MG BASE/5ML~A~062206~001
~~Approved Prior to Jan 1, 1982~No~DISCN~FACTA FARMACEUTICI SPA
~~Apr 20, 1988~No~DISCN~FACTA FARMACEUTICI SPA
~~Approved Prior to Jan 1, 1982~No~DISCN~FACTA FARMACEUTICI SPA
~~Apr 20, 1988~No~DISCN~FACTA FARMACEUTICI SPA
CEFACLOR~FOR SUSPENSION;ORAL~CEFACLOR~IVAX SUB TEVA PHARMS~EQ 125MG BASE/5ML~A~0
64087~001~~Apr 28, 1995~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICA
LS USA
LS USA
LS USA
LS USA
CEFACLOR~FOR SUSPENSION;ORAL~CEFACLOR~RANBAXY~EQ 125MG BASE/5ML~A~064166~001~~Oc
t 2, 1997~No~DISCN~RANBAXY PHARMACEUTICALS INC
CEFACLOR~FOR SUSPENSION;ORAL~CEFACLOR~WATSON LABS INC~EQ 125MG BASE/5ML~A~064204
~001~~Feb 18, 1998~No~DISCN~WATSON LABORATORIES INC
CEFACLOR~FOR SUSPENSION;ORAL~CEFACLOR~YUNG SHIN PHARM~EQ 125MG BASE/5ML~A~065412
~001~AB~Feb 17, 2012~No~RX~YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD

~004~AB~Feb 17, 2012~Yes~RX~YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~ANI PHARMS INC~
EQ 125MG BASE/5ML~A~062698~001~~Mar 1, 1989~No~DISCN~ANI PHARMACEUTICALS INC
EQ 250MG BASE/5ML~A~065278~001~~Jan 20, 2006~No~DISCN~ANI PHARMACEUTICALS INC
EQ 500MG BASE/5ML~A~065278~002~~Jan 20, 2006~No~DISCN~ANI PHARMACEUTICALS INC
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~APOTHECON~EQ 12
5MG BASE/5ML~A~062334~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC
DIV BRISTOL MYERS SQUIBB
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~AUROBINDO~EQ 25
0MG BASE/5ML~A~065349~001~AB~Apr 25, 2013~No~RX~AUROBINDO PHARMA LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~AUROBINDO~EQ 50
0MG BASE/5ML~A~065349~002~AB~Apr 25, 2013~No~RX~AUROBINDO PHARMA LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~HIKMA PHARMS~EQ
250MG BASE/5ML~A~091036~001~AB~Nov 28, 2012~No~RX~HIKMA PHARMACEUTICALS
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~HIKMA PHARMS~EQ
500MG BASE/5ML~A~091036~002~AB~Nov 28, 2012~No~RX~HIKMA PHARMACEUTICALS
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~LUPIN~EQ 250MG
BASE/5ML~A~065396~001~AB~Feb 21, 2008~No~RX~LUPIN LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~LUPIN~EQ 500MG
BASE/5ML~A~065396~002~AB~Feb 21, 2008~Yes~RX~LUPIN LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~ORCHID HLTHCARE
~EQ 250MG BASE/5ML~A~065307~002~AB~Oct 16, 2006~No~RX~ORCHID HEALTHCARE
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~ORCHID HLTHCARE
~EQ 500MG BASE/5ML~A~065307~003~AB~Oct 16, 2006~No~RX~ORCHID HEALTHCARE
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~CEFADROXIL~RANBAXY~EQ 125M
G BASE/5ML~A~065115~001~~Mar 26, 2003~No~RX~RANBAXY LABORATORIES LTD
G BASE/5ML~A~065115~002~AB~Mar 26, 2003~No~RX~RANBAXY LABORATORIES LTD
G BASE/5ML~A~065115~003~AB~Mar 26, 2003~No~RX~RANBAXY LABORATORIES LTD
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~AUROBINDO PHARMA~125MG/5ML~A~065473~001~AB
~Dec 14, 2007~No~RX~AUROBINDO PHARMA LTD
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~AUROBINDO PHARMA~250MG/5ML~A~065473~002~AB
~Dec 14, 2007~No~RX~AUROBINDO PHARMA LTD
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~LUPIN~125MG/5ML~A~065259~001~AB~May 31, 20
06~No~RX~LUPIN LTD
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~LUPIN~250MG/5ML~A~065259~002~AB~May 7, 200
7~No~RX~LUPIN LTD
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~ORCHID HLTHCARE~125MG/5ML~A~065429~001~AB~
Jul 18, 2007~No~RX~ORCHID HEALTHCARE
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~ORCHID HLTHCARE~250MG/5ML~A~065429~002~AB~
Jul 18, 2007~No~RX~ORCHID HEALTHCARE
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~SANDOZ~125MG/5ML~A~065337~001~AB~Apr 6, 20
07~No~RX~SANDOZ INC
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~SANDOZ~250MG/5ML~A~065337~002~AB~Apr 6, 20
07~Yes~RX~SANDOZ INC
CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~TEVA PHARMS~125MG/5ML~A~065332~001~AB~May

CEFDINIR~FOR SUSPENSION;ORAL~CEFDINIR~TEVA PHARMS~250MG/5ML~A~065332~002~AB~May
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~CEFPODOXIME PROXETIL~AUROBINDO PHARMA L
TD~EQ 50MG BASE/5ML~A~065409~001~AB~Jun 8, 2007~No~RX~AUROBINDO PHARMA LTD
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~CEFPODOXIME PROXETIL~AUROBINDO PHARMA L
TD~EQ 100MG BASE/5ML~A~065409~002~AB~Jun 8, 2007~No~RX~AUROBINDO PHARMA LTD
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~CEFPODOXIME PROXETIL~RANBAXY~EQ 50MG BA
SE/5ML~A~065082~001~AB~May 31, 2002~No~RX~RANBAXY LABORATORIES LTD
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~CEFPODOXIME PROXETIL~RANBAXY~EQ 100MG B
ASE/5ML~A~065082~002~AB~May 31, 2002~No~RX~RANBAXY LABORATORIES LTD
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~CEFPODOXIME PROXETIL~SANDOZ~EQ 50MG BAS
E/5ML~A~090031~001~AB~Jan 14, 2009~No~RX~SANDOZ INC
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~CEFPODOXIME PROXETIL~SANDOZ~EQ 100MG BA
SE/5ML~A~090031~002~AB~Jan 14, 2009~Yes~RX~SANDOZ INC
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~APOTEX INC~125MG/5ML~A~065351~001~AB~Feb
29, 2012~No~RX~APOTEX INC
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~APOTEX INC~250MG/5ML~A~065351~002~AB~Feb
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~AUROBINDO PHARMA~125MG/5ML~A~065381~001~
AB~Jan 30, 2007~No~RX~AUROBINDO PHARMA LTD
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~AUROBINDO PHARMA~250MG/5ML~A~065381~002~
AB~Jan 30, 2007~No~RX~AUROBINDO PHARMA LTD
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~LUPIN~125MG/5ML~A~065261~001~AB~Dec 19,
2005~No~RX~LUPIN LTD
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~LUPIN~250MG/5ML~A~065261~002~AB~Dec 19,
2005~Yes~RX~LUPIN LTD
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~ORCHID HLTHCARE~125MG/5ML~A~065284~002~A
B~Dec 30, 2005~No~RX~ORCHID HEALTHCARE
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~ORCHID HLTHCARE~250MG/5ML~A~065284~001~A
B~Dec 30, 2005~No~RX~ORCHID HEALTHCARE
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~RANBAXY LABS LTD~125MG/5ML~A~065202~001~
~Jun 30, 2006~No~DISCN~RANBAXY LABORATORIES LTD
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~RANBAXY LABS LTD~250MG/5ML~A~065202~002~
~Jun 30, 2006~No~DISCN~RANBAXY LABORATORIES LTD
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~SANDOZ~125MG/5ML~A~065257~001~AB~Dec 8,
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~SANDOZ~250MG/5ML~A~065257~002~AB~Dec 8,
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~TEVA PHARMS~125MG/5ML~A~065236~001~AB~De
c 8, 2005~No~RX~TEVA PHARMACEUTICALS USA
CEFPROZIL~FOR SUSPENSION;ORAL~CEFPROZIL~TEVA PHARMS~250MG/5ML~A~065236~002~AB~De
c 8, 2005~No~RX~TEVA PHARMACEUTICALS USA
CEFUROXIME AXETIL~FOR SUSPENSION;ORAL~CEFTIN~GLAXOSMITHKLINE~EQ 125MG BASE/5ML~N
~050672~001~AB~Jun 30, 1994~No~RX~GLAXOSMITHKLINE
CEFUROXIME AXETIL~FOR SUSPENSION;ORAL~CEFTIN~GLAXOSMITHKLINE~EQ 250MG BASE/5ML~N
~050672~002~AB~Apr 29, 1997~Yes~RX~GLAXOSMITHKLINE
CEFUROXIME AXETIL~FOR SUSPENSION;ORAL~CEFUROXIME AXETIL~RANBAXY~EQ 125MG BASE/5M
L~A~065323~001~AB~Feb 5, 2008~No~RX~RANBAXY LABORATORIES LTD
CEFUROXIME AXETIL~FOR SUSPENSION;ORAL~CEFUROXIME AXETIL~RANBAXY~EQ 250MG BASE/5M
L~A~065323~002~AB~Feb 5, 2008~No~RX~RANBAXY LABORATORIES LTD
CEFPROZIL~FOR SUSPENSION;ORAL~CEFZIL~CORDEN PHARMA~125MG/5ML~N~050665~001~~Dec 2
3, 1991~No~DISCN~CORDEN PHARMA LATINA SPA
CEFPROZIL~FOR SUSPENSION;ORAL~CEFZIL~CORDEN PHARMA~250MG/5ML~N~050665~002~~Dec 2
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~APOTHECON~EQ 125MG BASE/5ML~A~062986~0
01~~Apr 18, 1991~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~APOTHECON~EQ 250MG BASE/5ML~A~062987~0
01~~Jul 25, 1989~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~BARR~EQ 125MG BASE/5ML~A~062778~001~~A

ug 6, 1987~No~DISCN~BARR LABORATORIES INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~BARR~EQ 250MG BASE/5ML~A~062777~001~~A
ug 6, 1987~No~DISCN~BARR LABORATORIES INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~FACTA FARMA~EQ 100MG BASE/ML~A~062117~
001~~Approved Prior to Jan 1, 1982~No~DISCN~FACTA FARMACEUTICI SPA
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~FACTA FARMA~EQ 125MG BASE/5ML~A~062117
~002~~Approved Prior to Jan 1, 1982~No~DISCN~FACTA FARMACEUTICI SPA
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~FACTA FARMA~EQ 250MG BASE/5ML~A~062117
~003~~Approved Prior to Jan 1, 1982~No~DISCN~FACTA FARMACEUTICI SPA
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~HIKMA PHARMS~EQ 125MG BASE/5ML~A~06544
4~001~~Aug 28, 2009~No~DISCN~HIKMA PHARMACEUTICALS
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~HIKMA PHARMS~EQ 250MG BASE/5ML~A~06544
4~002~~Aug 28, 2009~No~DISCN~HIKMA PHARMACEUTICALS
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~LUPIN~EQ 125MG BASE/5ML~A~065234~001~A
B~Aug 17, 2005~No~RX~LUPIN LTD
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~LUPIN~EQ 250MG BASE/5ML~A~065234~002~A
B~Aug 17, 2005~No~RX~LUPIN LTD
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~ORCHID HLTHCARE~EQ 125MG BASE/5ML~A~06
5326~001~AB~Jul 10, 2006~No~RX~ORCHID HEALTHCARE
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~ORCHID HLTHCARE~EQ 250MG BASE/5ML~A~06
5326~002~AB~Jul 10, 2006~No~RX~ORCHID HEALTHCARE
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~RANBAXY~EQ 125MG BASE/5ML~A~065081~001
~~Jul 27, 2001~No~DISCN~RANBAXY LABORATORIES LTD
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~RANBAXY~EQ 250MG BASE/5ML~A~065081~002
~~Jul 27, 2001~No~DISCN~RANBAXY LABORATORIES LTD
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~TEVA~EQ 125MG BASE/5ML~A~062703~001~AB
~Feb 13, 1987~No~RX~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~TEVA~EQ 125MG BASE/5ML~A~062767~001~~J
un 16, 1987~No~DISCN~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~TEVA~EQ 125MG BASE/5ML~A~062873~001~~M
ay 23, 1988~No~DISCN~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~TEVA~EQ 250MG BASE/5ML~A~062703~002~AB
~Feb 13, 1987~Yes~RX~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~TEVA~EQ 250MG BASE/5ML~A~062768~001~~J
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~TEVA~EQ 250MG BASE/5ML~A~062867~001~~A
pr 15, 1988~No~DISCN~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~VITARINE~EQ 125MG BASE/5ML~A~062779~00
1~~Dec 22, 1987~No~DISCN~VITARINE PHARMACEUTICALS INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~VITARINE~EQ 250MG BASE/5ML~A~062781~00
1~~Dec 22, 1987~No~DISCN~VITARINE PHARMACEUTICALS INC
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~YUNG SHIN PHARM~EQ 125MG BASE/5ML~A~06
5336~001~~Jul 25, 2007~No~DISCN~YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEPHALEXIN~FOR SUSPENSION;ORAL~CEPHALEXIN~YUNG SHIN PHARM~EQ 250MG BASE/5ML~A~06
5336~002~~Jul 25, 2007~No~DISCN~YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEPHRADINE~FOR SUSPENSION;ORAL~CEPHRADINE~BARR~125MG/5ML~A~062858~001~~May 19, 1
CEPHRADINE~FOR SUSPENSION;ORAL~CEPHRADINE~BARR~250MG/5ML~A~062859~001~~May 19, 1
CEPHRADINE~FOR SUSPENSION;ORAL~CEPHRADINE~TEVA~125MG/5ML~A~062693~001~~Jan 9, 19
CEPHRADINE~FOR SUSPENSION;ORAL~CEPHRADINE~TEVA~250MG/5ML~A~062693~002~~Jan 9, 19
CIPROFLOXACIN~FOR SUSPENSION;ORAL~CIPRO~BAYER HLTHCARE~250MG/5ML~N~020780~001~AB
~Sep 26, 1997~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
CIPROFLOXACIN~FOR SUSPENSION;ORAL~CIPRO~BAYER HLTHCARE~500MG/5ML~N~020780~002~AB
~Sep 26, 1997~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
CIPROFLOXACIN~FOR SUSPENSION;ORAL~CIPROFLOXACIN~LUPIN LTD~250MG/5ML~A~200563~001
~AB~Mar 5, 2014~No~RX~LUPIN LTD
CIPROFLOXACIN~FOR SUSPENSION;ORAL~CIPROFLOXACIN~LUPIN LTD~500MG/5ML~A~200563~002

~AB~Mar 5, 2014~No~RX~LUPIN LTD
CLARITHROMYCIN~FOR SUSPENSION;ORAL~CLARITHROMYCIN~RANBAXY~125MG/5ML~A~065382~001
~AB~Aug 30, 2007~No~RX~RANBAXY LABORATORIES LTD
CLARITHROMYCIN~FOR SUSPENSION;ORAL~CLARITHROMYCIN~RANBAXY~250MG/5ML~A~065382~002
~AB~Aug 30, 2007~No~RX~RANBAXY LABORATORIES LTD
CLARITHROMYCIN~FOR SUSPENSION;ORAL~CLARITHROMYCIN~SANDOZ~125MG/5ML~A~065283~002~
AB~Sep 4, 2007~No~RX~SANDOZ INC
CLARITHROMYCIN~FOR SUSPENSION;ORAL~CLARITHROMYCIN~SANDOZ~250MG/5ML~A~065283~003~
AB~Sep 4, 2007~No~RX~SANDOZ INC
E; SODIUM SULFATE ANHYDROUS~FOR SUSPENSION;ORAL~CO-LAV~VINTAGE PHARMS~240GM/BOT;
2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT~A~073428~001~~Jan 28, 1992~No~DISCN
~VINTAGE PHARMACEUTICALS
E; SODIUM SULFATE ANHYDROUS~FOR SUSPENSION;ORAL~COLOVAGE~DYNAPHARM~227.1GM/PACKE
T;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET~A~071320~001~~Apr 20,
1988~No~DISCN~DYNAPHARM INC
CYCLACILLIN~FOR SUSPENSION;ORAL~CYCLAPEN-W~WYETH AYERST~125MG/5ML~N~050508~001~~
Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
DICLOXACILLIN SODIUM~FOR SUSPENSION;ORAL~DICLOXACILLIN SODIUM~APOTHECON~EQ 62.5M
G BASE/5ML~A~061455~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DI
V BRISTOL MYERS SQUIBB
FLUCONAZOLE~FOR SUSPENSION;ORAL~DIFLUCAN~PFIZER~50MG/5ML~N~020090~001~AB~Dec 23,
1993~No~RX~PFIZER CHEMICALS DIV PFIZER INC
FLUCONAZOLE~FOR SUSPENSION;ORAL~DIFLUCAN~PFIZER~200MG/5ML~N~020090~002~AB~Dec 23
, 1993~Yes~RX~PFIZER CHEMICALS DIV PFIZER INC
DOXYCYCLINE~FOR SUSPENSION;ORAL~DOXYCHEL~RACHELLE~EQ 25MG BASE/5ML~A~061720~001~
~Approved Prior to Jan 1, 1982~No~DISCN~RACHELLE LABORATORIES INC
DOXYCYCLINE~FOR SUSPENSION;ORAL~DOXYCYCLINE~CHARTWELL LIFE SCI~EQ 25MG BASE/5ML~
A~065454~001~AB~Jul 16, 2008~No~RX~CHARTWELL LIFE SCIENCE LLC
DOXYCYCLINE~FOR SUSPENSION;ORAL~DOXYCYCLINE~LUPIN LTD~EQ 25MG BASE/5ML~A~201678~
001~AB~Mar 18, 2013~No~RX~LUPIN LTD
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~DURICEF~WARNER CHILCOTT~EQ
125MG BASE/5ML~N~050527~002~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHIL
COTT INC
COTT INC
COTT INC
DICLOXACILLIN SODIUM~FOR SUSPENSION;ORAL~DYNAPEN~APOTHECON~EQ 62.5MG BASE/5ML~N~
050337~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYE
RS SQUIBB
E; SODIUM SULFATE ANHYDROUS~FOR SUSPENSION;ORAL~E-Z-EM PREP LYTE~E Z EM~236GM/BO
T;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT~A~071278~001~~Nov 21, 1988~No~DIS
CN~E Z EM CO INC
FAMOTIDINE~FOR SUSPENSION;ORAL~FAMOTIDINE~HI-TECH PHARMA CO~40MG/5ML~A~201995~00
1~AB~May 30, 2014~No~RX~HI-TECH PHARMACAL CO INC
FAMOTIDINE~FOR SUSPENSION;ORAL~FAMOTIDINE~LUPIN LTD~40MG/5ML~A~090440~001~AB~Jun
FAMOTIDINE~FOR SUSPENSION;ORAL~FAMOTIDINE~NAVINTA LLC~40MG/5ML~A~091020~001~AB~M
ay 27, 2010~No~RX~NAVINTA LLC
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~AUROBINDO PHARM~50MG/5ML~A~079150~00
1~AB~Sep 18, 2009~No~RX~AUROBINDO PHARMA USA INC

FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~AUROBINDO PHARM~200MG/5ML~A~079150~0
02~AB~Sep 18, 2009~No~RX~AUROBINDO PHARMA USA INC
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~IVAX SUB TEVA PHARMS~50MG/5ML~A~0775
23~001~AB~Sep 12, 2007~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS U
SA
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~IVAX SUB TEVA PHARMS~200MG/5ML~A~077
523~002~AB~Sep 12, 2007~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS
USA
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~RANBAXY~50MG/5ML~A~076332~001~AB~Jul
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~RANBAXY~200MG/5ML~A~076332~002~AB~Ju
l 29, 2004~No~RX~RANBAXY LABORATORIES LTD
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~ROXANE~50MG/5ML~A~076246~001~AB~Jul
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~ROXANE~200MG/5ML~A~076246~002~AB~Jul
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~TARO PHARM INDS~50MG/5ML~A~076918~00
1~~Dec 18, 2006~No~DISCN~TARO PHARMACEUTICAL INDUSTRIES LTD
FLUCONAZOLE~FOR SUSPENSION;ORAL~FLUCONAZOLE~TARO PHARM INDS~200MG/5ML~A~076918~0
02~~Dec 18, 2006~No~DISCN~TARO PHARMACEUTICAL INDUSTRIES LTD
E; SODIUM SULFATE ANHYDROUS~FOR SUSPENSION;ORAL~GLYCOPREP~GOLDLINE~236GM/BOT;2.9
7GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT~A~072319~001~~Dec 23, 1988~No~DISCN~GO
LDLINE LABORATORIES INC
E; SODIUM SULFATE ANHYDROUS~FOR SUSPENSION;ORAL~GO-EVAC~VINTAGE PHARMS~236GM/BOT
;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT~A~073433~001~~Apr 28, 1992~No~DISC
N~VINTAGE PHARMACEUTICALS
ERYTHROMYCIN ESTOLATE~FOR SUSPENSION;ORAL~ILOSONE~DISTA~EQ 125MG BASE/5ML~A~0618
93~001~~Approved Prior to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO DIV ELI LILLY A
ND CO
CEPHALEXIN~FOR SUSPENSION;ORAL~KEFLEX~SHIONOGI INC~EQ 100MG BASE/ML~N~050406~003
~~Approved Prior to Jan 1, 1982~No~DISCN~SHIONOGI INC
CEPHALEXIN~FOR SUSPENSION;ORAL~KEFLEX~SHIONOGI INC~EQ 125MG BASE/5ML~N~050406~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~SHIONOGI INC
CEPHALEXIN~FOR SUSPENSION;ORAL~KEFLEX~SHIONOGI INC~EQ 250MG BASE/5ML~N~050406~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~SHIONOGI INC
AMOXICILLIN~FOR SUSPENSION;ORAL~LAROTID~DR REDDYS LABS INC~125MG/5ML~A~062226~00
3~AB~Approved Prior to Jan 1, 1982~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~FOR SUSPENSION;ORAL~LAROTID~DR REDDYS LABS INC~250MG/5ML~A~062226~00
4~AB~Approved Prior to Jan 1, 1982~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~FOR SUSPENSION;ORAL~LAROTID~GLAXOSMITHKLINE~50MG/ML~N~050460~006~~Ap
LORACARBEF~FOR SUSPENSION;ORAL~LORABID~KING PHARMS~100MG/5ML~N~050667~001~~Dec 3
1, 1991~No~DISCN~KING PHARMACEUTICALS INC
LORACARBEF~FOR SUSPENSION;ORAL~LORABID~KING PHARMS~200MG/5ML~N~050667~002~~Dec 3
FOSFOMYCIN TROMETHAMINE~FOR SUSPENSION;ORAL~MONUROL~ZAMBON SPA~EQ 3GM BASE/PACKE
T~N~050717~001~~Dec 19, 1996~Yes~RX~ZAMBON SPA ITALY
OMEPRAZOLE; SODIUM BICARBONATE~FOR SUSPENSION;ORAL~OMEPRAZOLE AND SODIUM BICARBO
NATE~PAR PHARM~20MG/PACKET;1.68GM/PACKET~A~079182~001~~Apr 19, 2013~No~DISCN~PAR
PHARMACEUTICAL INC
OMEPRAZOLE; SODIUM BICARBONATE~FOR SUSPENSION;ORAL~OMEPRAZOLE AND SODIUM BICARBO
NATE~PAR PHARM~40MG/PACKET;1.68GM/PACKET~A~079182~002~~Apr 19, 2013~No~DISCN~PAR
PHARMACEUTICAL INC
CEFDINIR~FOR SUSPENSION;ORAL~OMNICEF~ABBVIE~125MG/5ML~N~050749~001~~Dec 4, 1997~
No~DISCN~ABBVIE INC
CEFDINIR~FOR SUSPENSION;ORAL~OMNICEF~ABBVIE~250MG/5ML~N~050749~002~~Jul 29, 2004
~No~DISCN~ABBVIE INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~OMNIPEN (AMPICILLIN)~WYETH

AYERST~100MG/ML~A~060625~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERS
T LABORATORIES
AYERST~125MG/5ML~A~060625~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYER
ST LABORATORIES
ST LABORATORIES
ST LABORATORIES
DICLOXACILLIN SODIUM~FOR SUSPENSION;ORAL~PATHOCIL~WYETH AYERST~EQ 62.5MG BASE/5M
L~N~050092~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
E; SODIUM SULFATE ANHYDROUS~FOR SUSPENSION;ORAL~PEG-LYTE~SANDOZ~236GM/BOT;2.97GM
/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT~A~073098~001~~Aug 31, 1993~No~DISCN~SANDO
Z INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~PENBRITIN~WYETH AYERST~EQ 1
00MG BASE/ML~N~050019~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST L
ABORATORIES
25MG BASE/5ML~N~050019~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST
LABORATORIES
50MG BASE/5ML~N~050019~003~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST
LABORATORIES
FAMOTIDINE~FOR SUSPENSION;ORAL~PEPCID~SALIX PHARMS~40MG/5ML~N~019527~001~AB~Feb
2, 1987~Yes~RX~SALIX PHARMACEUTICALS INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~PFIZERPEN-A~PFIZER~EQ 125MG
BASE/5ML~A~062049~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORI
ES DIV PFIZER INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~PFIZERPEN-A~PFIZER~EQ 250MG
BASE/5ML~A~062049~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORI
ES DIV PFIZER INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~POLYCILLIN~APOTHECON~EQ 125
MG BASE/5ML~A~062297~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC D
IV BRISTOL MYERS SQUIBB
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~POLYCILLIN~APOTHECON~EQ 250
MG BASE/5ML~A~062297~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC D
IV BRISTOL MYERS SQUIBB
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~POLYCILLIN~BRISTOL~EQ 100MG
BASE/ML~N~050308~004~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORI
ES INC DIV BRISTOL MYERS CO
BASE/5ML~N~050308~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATOR
IES INC DIV BRISTOL MYERS CO
AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID~FOR SUSPENSION;ORAL~POLYCILLIN-PRB~
APOTHECON~EQ 3.5GM BASE/BOT;1GM/BOT~A~061898~001~~Approved Prior to Jan 1, 1982~
No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID~FOR SUSPENSION;ORAL~POLYCILLIN-PRB~
BRISTOL~EQ 3.5GM BASE/BOT;1GM/BOT~N~050457~001~~Approved Prior to Jan 1, 1982~No
~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
AMOXICILLIN~FOR SUSPENSION;ORAL~POLYMOX~APOTHECON~125MG/5ML~A~061851~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB

AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~PRINCIPEN~APOTHECON~EQ 100M
G BASE/ML~A~061394~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV
BRISTOL MYERS SQUIBB
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~PRINCIPEN '125'~APOTHECON~E
Q 125MG BASE/5ML~A~060127~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON
SUB BRISTOL MYERS SQUIBB CO
AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID~FOR SUSPENSION;ORAL~PROBAMPACIN~TEV
A~EQ 3.5GM BASE/BOT;1GM/BOT~A~061741~001~~Approved Prior to Jan 1, 1982~No~DISCN
SEVELAMER CARBONATE~FOR SUSPENSION;ORAL~RENVELA~GENZYME~2.4GM/PACKET~N~022318~00
2~~Feb 18, 2009~Yes~RX~GENZYME CORP
SEVELAMER CARBONATE~FOR SUSPENSION;ORAL~RENVELA~GENZYME~800MG/PACKET~N~022318~00
1~~Aug 12, 2009~No~RX~GENZYME CORP
SILDENAFIL CITRATE~FOR SUSPENSION;ORAL~REVATIO~PFIZER~EQ 10MG BASE/ML~N~203109~0
01~~Aug 30, 2012~Yes~RX~PFIZER INC
BACAMPICILLIN HYDROCHLORIDE~FOR SUSPENSION;ORAL~SPECTROBID~PFIZER~125MG/5ML~N~05
0556~001~~Mar 23, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
CEFIXIME~FOR SUSPENSION;ORAL~SUPRAX~LEDERLE~100MG/5ML~N~050622~001~~Apr 28, 1989
~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
CEFIXIME~FOR SUSPENSION;ORAL~SUPRAX~LUPIN LTD~500MG/5ML~N~202091~001~~Feb 20, 20
13~Yes~RX~LUPIN LTD
CEFIXIME~FOR SUSPENSION;ORAL~SUPRAX~LUPIN PHARMS~100MG/5ML~A~065129~001~~Feb 23,
CEFIXIME~FOR SUSPENSION;ORAL~SUPRAX~LUPIN PHARMS~200MG/5ML~A~065355~001~~Apr 10,
OSELTAMIVIR PHOSPHATE~FOR SUSPENSION;ORAL~TAMIFLU~ROCHE~EQ 6MG BASE/ML~N~021246~
002~~Mar 21, 2011~Yes~RX~HOFFMANN LA ROCHE INC
OSELTAMIVIR PHOSPHATE~FOR SUSPENSION;ORAL~TAMIFLU~ROCHE~EQ 12MG BASE/ML~N~021246
~001~~Dec 14, 2000~No~DISCN~HOFFMANN LA ROCHE INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~FOR SUSPENSION;ORAL~TOTACILLIN~GLAXOSMITHKLINE~
EQ 125MG BASE/5ML~A~060666~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMIT
HKLINE
HKLINE
HKLINE

HKLINE
AMOXICILLIN~FOR SUSPENSION;ORAL~TRIMOX~APOTHECON~50MG/ML~A~061886~001~~Approved
Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
AMOXICILLIN~FOR SUSPENSION;ORAL~TRIMOX~APOTHECON~125MG/5ML~A~061886~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
d Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL MYERS SQUIBB CO
AMOXICILLIN~FOR SUSPENSION;ORAL~TRIMOX~APOTHECON~125MG/5ML~A~062885~001~~Mar 8,
AMOXICILLIN~FOR SUSPENSION;ORAL~TRIMOX~APOTHECON~250MG/5ML~A~062885~002~~Mar 8,
CEFADROXIL/CEFADROXIL HEMIHYDRATE~FOR SUSPENSION;ORAL~ULTRACEF~BRISTOL~EQ 125MG
BASE/5ML~A~062376~001~~Mar 16, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTO
L MYERS CO
L MYERS CO
L MYERS CO
AMOXICILLIN~FOR SUSPENSION;ORAL~UTIMOX~PARKE DAVIS~125MG/5ML~A~062127~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
AMOXICILLIN~FOR SUSPENSION;ORAL~UTIMOX~PARKE DAVIS~250MG/5ML~A~062127~002~~Appro
PENICILLIN V~FOR SUSPENSION;ORAL~V-CILLIN~LILLY~125MG/0.6ML~A~060002~001~~Approv
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~VANTIN~PHARMACIA AND UPJOHN~EQ 50MG BAS
E/5ML~N~050675~001~~Aug 7, 1992~No~DISCN~PHARMACIA AND UPJOHN CO
CEFPODOXIME PROXETIL~FOR SUSPENSION;ORAL~VANTIN~PHARMACIA AND UPJOHN~EQ 100MG BA
SE/5ML~N~050675~002~~Aug 7, 1992~No~DISCN~PHARMACIA AND UPJOHN CO
CEPHRADINE~FOR SUSPENSION;ORAL~VELOSEF '125'~APOTHECON~125MG/5ML~A~061763~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CEPHRADINE~FOR SUSPENSION;ORAL~VELOSEF '250'~APOTHECON~250MG/5ML~A~061763~002~~A
HETACILLIN~FOR SUSPENSION;ORAL~VERSAPEN~BRISTOL~EQ 112.5MG AMPICIL/ML~A~061398~0
MYERS CO
HETACILLIN~FOR SUSPENSION;ORAL~VERSAPEN~BRISTOL~EQ 112.5MG AMPICIL/5ML~N~050060~
MYERS CO
HETACILLIN~FOR SUSPENSION;ORAL~VERSAPEN~BRISTOL~EQ 112.5MG AMPICIL/ML~N~050060~0
MYERS CO
HETACILLIN~FOR SUSPENSION;ORAL~VERSAPEN~BRISTOL~EQ 225MG AMPICIL/5ML~A~061398~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL M
YERS CO
VORICONAZOLE~FOR SUSPENSION;ORAL~VFEND~PF PRISM CV~200MG/5ML~N~021630~001~AB~Dec
19, 2003~Yes~RX~PF PRISM CV
DOXYCYCLINE~FOR SUSPENSION;ORAL~VIBRAMYCIN~PFIZER~EQ 25MG BASE/5ML~N~050006~001~
AB~Approved Prior to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC
VORICONAZOLE~FOR SUSPENSION;ORAL~VORICONAZOLE~MYLAN PHARMS INC~200MG/5ML~A~20236

COLESEVELAM HYDROCHLORIDE~FOR SUSPENSION;ORAL~WELCHOL~DAIICHI SANKYO~1.875GM/PAC
KET~N~022362~001~~Oct 2, 2009~No~RX~DAIICHI SANKYO INC
COLESEVELAM HYDROCHLORIDE~FOR SUSPENSION;ORAL~WELCHOL~DAIICHI SANKYO~3.75GM/PACK
ET~N~022362~002~~Oct 2, 2009~Yes~RX~DAIICHI SANKYO INC
AMOXICILLIN~FOR SUSPENSION;ORAL~WYMOX~WYETH AYERST~125MG/5ML~A~062131~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
AMOXICILLIN~FOR SUSPENSION;ORAL~WYMOX~WYETH AYERST~250MG/5ML~A~062131~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
OMEPRAZOLE; SODIUM BICARBONATE~FOR SUSPENSION;ORAL~ZEGERID~SANTARUS INC~20MG/PAC
KET;1.68GM/PACKET~N~021636~001~~Jun 15, 2004~No~RX~SANTARUS INC
OMEPRAZOLE; SODIUM BICARBONATE~FOR SUSPENSION;ORAL~ZEGERID~SANTARUS INC~40MG/PAC
KET;1.68GM/PACKET~N~021636~002~~Dec 21, 2004~Yes~RX~SANTARUS INC
OMEPRAZOLE; SODIUM BICARBONATE~FOR SUSPENSION;ORAL~ZEGERID OTC~MSD CONSUMER~20MG
/PACKET;1.68GM/PACKET~N~022283~001~~Jun 17, 2013~Yes~OTC~MSD CONSUMER CARE INC
AZITHROMYCIN~FOR SUSPENSION;ORAL~ZITHROMAX~PFIZER~EQ 1GM BASE/PACKET~N~050693~00
1~~Sep 28, 1994~Yes~RX~PFIZER CENTRAL RESEARCH
AZITHROMYCIN~FOR SUSPENSION;ORAL~ZITHROMAX~PFIZER~EQ 100MG BASE/5ML~N~050710~001
~AB~Oct 19, 1995~No~RX~PFIZER CHEMICALS DIV PFIZER INC
AZITHROMYCIN~FOR SUSPENSION;ORAL~ZITHROMAX~PFIZER~EQ 200MG BASE/5ML~N~050710~002
~AB~Oct 19, 1995~Yes~RX~PFIZER CHEMICALS DIV PFIZER INC
LINEZOLID~FOR SUSPENSION;ORAL~ZYVOX~PHARMACIA AND UPJOHN~100MG/5ML~N~021132~001~
~Apr 18, 2000~Yes~RX~PHARMACIA AND UPJOHN CO
NITRIC OXIDE~GAS;INHALATION~INOMAX~INO~100PPM~N~020845~002~~Dec 23, 1999~No~RX~I
NO THERAPEUTICS INC
NITRIC OXIDE~GAS;INHALATION~INOMAX~INO~800PPM~N~020845~003~~Dec 23, 1999~Yes~RX~
INO THERAPEUTICS INC
KRYPTON, KR-81M~GAS;INHALATION~MPI KRYPTON 81M GENERATOR~GE HEALTHCARE~N/A~N~018
XENON XE-127~GAS;INHALATION~XENON XE 127~MALLINCKRODT~5mCi/VIAL~N~018536~001~~Oc
t 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
XENON XE-127~GAS;INHALATION~XENON XE 127~MALLINCKRODT~10mCi/VIAL~N~018536~002~~O
ct 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
XENON XE-133~GAS;INHALATION~XENON XE 133~GE HEALTHCARE~1 CI/AMP~N~017256~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
XENON XE-133~GAS;INHALATION~XENON XE 133~GE HEALTHCARE~10mCi/VIAL~N~017687~002~~
Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
XENON XE-133~GAS;INHALATION~XENON XE 133~GE HEALTHCARE~20mCi/VIAL~N~017687~003~~
XENON XE-133~GAS;INHALATION~XENON XE 133~GEN ELECTRIC~5-100 CI/CYLINDER~N~017550
~001~~Approved Prior to Jan 1, 1982~No~DISCN~GENERAL ELECTRIC CO
XENON XE-133~GAS;INHALATION~XENON XE 133~GEN ELECTRIC~0.25-5 CI/AMP~N~017550~003
~~Approved Prior to Jan 1, 1982~No~DISCN~GENERAL ELECTRIC CO
XENON XE-133~GAS;INHALATION~XENON XE 133~LANTHEUS MEDCL~10mCi/VIAL~N~017284~001~
~Approved Prior to Jan 1, 1982~No~RX~LANTHEUS MEDICAL IMAGING INC
XENON XE-133~GAS;INHALATION~XENON XE 133~LANTHEUS MEDCL~20mCi/VIAL~N~017284~002~
AA~Approved Prior to Jan 1, 1982~No~RX~LANTHEUS MEDICAL IMAGING INC
XENON XE-133~GAS;INHALATION~XENON XE 133~MALLINCKRODT~10mCi/VIAL~N~018327~001~~M
ar 9, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
XENON XE-133~GAS;INHALATION~XENON XE 133~MALLINCKRODT~20mCi/VIAL~N~018327~002~~M
ar 9, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
XENON XE-133~GAS;INHALATION~XENON XE 133-V.S.S.~GE HEALTHCARE~10mCi/VIAL~N~01768
BETAMETHASONE DIPROPIONATE~GEL, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~FOU
GERA PHARMS~EQ 0.05% BASE~A~075276~001~AB~May 13, 2003~Yes~RX~FOUGERA PHARMACEUT
ICALS INC
BETAMETHASONE DIPROPIONATE~GEL, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~TAR
O~EQ 0.05% BASE~A~076508~001~AB~Dec 2, 2003~No~RX~TARO PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~GEL, AUGMENTED;TOPICAL~DIPROLENE~SCHERING~EQ 0.05% BA
SE~N~019408~002~~Nov 22, 1991~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP

CYANOCOBALAMIN~GEL, METERED;NASAL~NASCOBAL~PAR PHARM~0.5MG/INH~N~019722~001~~Nov
5, 1996~No~DISCN~PAR PHARMACEUTICAL INC
TESTOSTERONE~GEL, METERED;NASAL~NATESTO~ENDO VENTURES LTD~5.5MG/0.122GM ACTUATIO
N~N~205488~001~~May 28, 2014~No~RX~ENDO VENTURES LTD
TESTOSTERONE~GEL, METERED;TRANSDERMAL~ANDROGEL~ABBVIE~1.62% (20.25MG/1.25GM ACTU
ATION)~N~022309~001~~Apr 29, 2011~Yes~RX~ABBVIE INC
TESTOSTERONE~GEL, METERED;TRANSDERMAL~ANDROGEL~ABBVIE~12.5MG/1.25GM ACTUATION~N~
021015~003~AB~Sep 26, 2003~Yes~RX~ABBVIE INC
ESTRADIOL~GEL, METERED;TRANSDERMAL~ELESTRIN~MEDA PHARMS~0.06% (0.87GM/ACTIVATION
)~N~021813~001~~Dec 15, 2006~Yes~RX~MEDA PHARMACEUTICALS INC
ESTRADIOL~GEL, METERED;TRANSDERMAL~ESTROGEL~ASCEND THERAPS US~0.06% (1.25GM/ACTI
VATION)~N~021166~002~~Feb 9, 2004~Yes~RX~ASCEND THERAPEUTICS US LLC
TESTOSTERONE~GEL, METERED;TRANSDERMAL~FORTESTA~ENDO PHARMS~10MG/0.5GM ACTUATION~
N~021463~001~~Dec 29, 2010~Yes~RX~ENDO PHARMACEUTICALS INC
OXYBUTYNIN~GEL, METERED;TRANSDERMAL~GELNIQUE 3%~WATSON LABS INC~3%~N~202513~001~
~Dec 7, 2011~Yes~RX~WATSON LABORATORIES INC
TESTOSTERONE~GEL, METERED;TRANSDERMAL~TESTOSTERONE~PERRIGO ISRAEL~12.5MG/1.25GM
ACTUATION~N~203098~001~AB~Jan 31, 2013~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
TESTOSTERONE~GEL, METERED;TRANSDERMAL~VOGELXO~UPSHER SMITH~12.5MG/1.25GM ACTUATI
ON~N~204399~003~BX~Jun 4, 2014~No~RX~UPSHER SMITH LABORATORIES INC
SODIUM MONOFLUOROPHOSPHATE~GEL;DENTAL~EXTRA-STRENGTH AIM~CHESEBROUGH PONDS~1.2%~
N~019518~002~~Aug 6, 1986~No~DISCN~CHESEBROUGH PONDS INC
DINOPROSTONE~GEL;ENDOCERVICAL~PREPIDIL~PHARMACIA AND UPJOHN~0.5MG/3GM~N~019617~0
01~~Dec 9, 1992~Yes~RX~PHARMACIA AND UPJOHN CO
LIDOCAINE HYDROCHLORIDE~GEL;OPHTHALMIC~AKTEN~AKORN~3.5%~N~022221~001~~Oct 7, 200
8~Yes~RX~AKORN INC
LOTEPREDNOL ETABONATE~GEL;OPHTHALMIC~LOTEMAX~BAUSCH AND LOMB INC~0.5%~N~202872~0
01~~Sep 28, 2012~Yes~RX~BAUSCH AND LOMB INC
PILOCARPINE HYDROCHLORIDE~GEL;OPHTHALMIC~PILOPINE HS~ALCON~4%~N~018796~001~~Oct
1, 1984~Yes~RX~ALCON LABORATORIES INC
GANCICLOVIR~GEL;OPHTHALMIC~ZIRGAN~BAUSCH AND LOMB~0.15%~N~022211~001~~Sep 15, 20
09~Yes~RX~BAUSCH AND LOMB INC
LIDOCAINE; PRILOCAINE~GEL;PERIODONTAL~ORAQIX~DENTSPLY PHARM~2.5%;2.5%~N~021451~0
01~~Dec 19, 2003~Yes~RX~DENTSPLY PHARMACEUTICAL INC
DIAZEPAM~GEL;RECTAL~DIASTAT~VALEANT PHARMS NORTH~2.5MG/0.5ML (5MG/ML)~N~020648~0
01~~Jul 29, 1997~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
DIAZEPAM~GEL;RECTAL~DIASTAT~VALEANT PHARMS NORTH~5MG/ML (5MG/ML) **Federal Regis
fficacy reasons**~N~020648~002~~Jul 29, 1997~No~DISCN~VALEANT PHARMACEUTICALS NO
RTH AMERICA LLC
DIAZEPAM~GEL;RECTAL~DIASTAT~VALEANT PHARMS NORTH~10MG/2ML (5MG/ML)~N~020648~003~
~Jul 29, 1997~No~DISCN~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
DIAZEPAM~GEL;RECTAL~DIASTAT ACUDIAL~VALEANT PHARMS NORTH~10MG/2ML (5MG/ML)~N~020
648~007~~Sep 15, 2005~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
DIAZEPAM~GEL;RECTAL~DIASTAT ACUDIAL~VALEANT PHARMS NORTH~20MG/4ML (5MG/ML)~N~020
648~006~~Sep 15, 2005~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~ACANYA~DOW PHARM~2.5%;EQ 1.2
% BASE~N~050819~001~~Oct 23, 2008~Yes~RX~DOW PHARMACEUTICAL SCIENCES
DAPSONE~GEL;TOPICAL~ACZONE~ALLERGAN~5%~N~021794~001~~Jul 7, 2005~Yes~RX~ALLERGAN
INC
ADAPALENE~GEL;TOPICAL~ADAPALENE~ACTAVIS MID ATLANTIC~0.3%~A~201000~001~AB~Oct 27
, 2014~No~RX~ACTAVIS MID ATLANTIC LLC
ADAPALENE~GEL;TOPICAL~ADAPALENE~GLENMARK GENERICS~0.1%~A~091314~001~AB~Jul 1, 20
10~No~RX~GLENMARK GENERICS INC USA
ADAPALENE~GEL;TOPICAL~ADAPALENE~PLIVA HRVATSKA DOO~0.1%~A~090962~001~AB~Jun 2, 2
010~No~RX~PLIVA HRVATSKA DOO

ADAPALENE~GEL;TOPICAL~ADAPALENE~TOLMAR~0.3%~A~200298~001~AB~Jun 14, 2012~No~RX~T
OLMAR INC
TRIAMCINOLONE ACETONIDE~GEL;TOPICAL~ARISTOGEL~ASTELLAS~0.1%~A~083380~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
TRETINOIN~GEL;TOPICAL~ATRALIN~DOW PHARM~0.05%~N~022070~001~~Jul 26, 2007~Yes~RX~
DOW PHARMACEUTICAL SCIENCES
TRETINOIN~GEL;TOPICAL~AVITA~MYLAN~0.025%~N~020400~001~BT~Jan 29, 1998~No~RX~MYLA
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~BENZACLIN~VALEANT BERMUDA~5%
;EQ 1% BASE~N~050756~001~AB~Dec 21, 2000~Yes~RX~VALEANT INTERNATIONAL BERMUDA
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~BENZACLIN~VALEANT BERMUDA~5%
;EQ 1% BASE~N~050756~002~~Apr 20, 2007~No~DISCN~VALEANT INTERNATIONAL BERMUDA
BENZOYL PEROXIDE; ERYTHROMYCIN~GEL;TOPICAL~BENZAMYCIN~VALEANT INTL~5%;3%~N~05055
7~001~AB~Oct 26, 1984~Yes~RX~VALEANT INTERNATIONAL SRL
BENZOYL PEROXIDE; ERYTHROMYCIN~GEL;TOPICAL~BENZAMYCIN PAK~VALEANT LUXEMBOURG~5%;
3%~N~050769~001~~Nov 27, 2000~Yes~RX~VALEANT PHARMACEUTICALS LUXEMBOURG SARL
CICLOPIROX~GEL;TOPICAL~CICLOPIROX~FOUGERA PHARMS~0.77%~A~077896~001~AB~Jun 10, 2
CICLOPIROX~GEL;TOPICAL~CICLOPIROX~GLENMARK GENERICS~0.77%~A~091595~001~AB~Feb 29
, 2012~No~RX~GLENMARK GENERICS LTD
CICLOPIROX~GEL;TOPICAL~CICLOPIROX~PADDOCK LLC~0.77%~A~078266~001~AB~Jan 7, 2009~
No~RX~PADDOCK LABORATORIES LLC
CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~CLEOCIN T~PHARMACIA AND UPJOHN~EQ 1% BASE~N~05
0615~001~AB~Jan 7, 1987~Yes~RX~PHARMACIA AND UPJOHN CO
CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~CLINDAGEL~PRECISION DERMAT~EQ 1% BASE~N~050782
~001~BT~Nov 27, 2000~Yes~RX~PRECISION DERMATOLOGY INC
CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~CLINDAMYCIN PHOSPHATE~FOUGERA PHARMS~EQ 1% BAS
E~A~064160~001~AB~Jan 28, 2000~No~RX~FOUGERA PHARMACEUTICALS INC
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~CLINDAMYCIN PHOSPHATE AND BE
NZOYL PEROXIDE~MYLAN PHARMS INC~5%;EQ 1% BASE~A~065443~001~AB~Aug 11, 2009~No~RX
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~CLINDAMYCIN PHOSPHATE AND BE
NZOYL PEROXIDE~PERRIGO ISRAEL~5%;1.2%~A~090979~001~AB~Jun 26, 2012~No~RX~PERRIGO
ISRAEL PHARMACEUTICALS LTD
CLOBETASOL PROPIONATE~GEL;TOPICAL~CLOBETASOL PROPIONATE~FOUGERA PHARMS~0.05%~A~0
75368~001~AB~Feb 15, 2000~No~RX~FOUGERA PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~GEL;TOPICAL~CLOBETASOL PROPIONATE~PERRIGO~0.05%~A~075027~0
01~AB~Oct 31, 1997~No~RX~PERRIGO CO
CLOBETASOL PROPIONATE~GEL;TOPICAL~CLOBETASOL PROPIONATE~TARO~0.05%~A~075279~001~
AB~May 28, 1999~No~RX~TARO PHARMACEUTICALS INC
PODOFILOX~GEL;TOPICAL~CONDYLOX~ACTAVIS LABS UT INC~0.5%~N~020529~001~~Mar 13, 19
97~Yes~RX~ACTAVIS LABORATORIES UT INC
DEXAMETHASONE~GEL;TOPICAL~DECADERM~MERCK~0.1%~N~013538~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~MERCK AND CO INC
DESONIDE~GEL;TOPICAL~DESONATE~BAYER HLTHCARE~0.05%~N~021844~001~~Oct 20, 2006~Ye
s~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
DESOXIMETASONE~GEL;TOPICAL~DESOXIMETASONE~PERRIGO NEW YORK~0.05%~A~077552~001~AB
~Jan 9, 2006~No~RX~PERRIGO NEW YORK INC
DESOXIMETASONE~GEL;TOPICAL~DESOXIMETASONE~VERSAPHARM~0.05%~A~090727~001~AB~Mar 1
0, 2011~No~RX~VERSAPHARM INC
DICLOFENAC SODIUM~GEL;TOPICAL~DICLOFENAC SODIUM ~TOLMAR~3%~A~200936~001~AB~Oct 2
8, 2013~No~RX~TOLMAR INC
ADAPALENE~GEL;TOPICAL~DIFFERIN~GALDERMA LABS LP~0.1%~N~020380~001~AB~May 31, 199
ADAPALENE~GEL;TOPICAL~DIFFERIN~GALDERMA LABS LP~0.3%~N~021753~001~AB~Jun 19, 200
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~DUAC~STIEFEL~5%;1.2%~N~05074
1~001~AB~Aug 26, 2002~Yes~RX~STIEFEL LABORATORIES INC
ERYTHROMYCIN~GEL;TOPICAL~E-GLADES~RENAISSANCE PHARMA~2%~A~065009~001~~Mar 18, 20
02~No~DISCN~RENAISSANCE PHARMA US HOLDINGS INC

CLOBETASOL PROPIONATE~GEL;TOPICAL~EMBELINE~HI TECH PHARMA~0.05%~A~076141~001~AB~
Apr 12, 2002~No~RX~HI TECH PHARMACAL CO INC
ERYTHROMYCIN~GEL;TOPICAL~EMGEL~ALTANA~2%~A~063107~001~~Aug 23, 1991~No~DISCN~ALT
ANA INC
ADAPALENE; BENZOYL PEROXIDE~GEL;TOPICAL~EPIDUO~GALDERMA LABS LP~0.1%;2.5%~N~0223
20~001~~Dec 8, 2008~Yes~RX~GALDERMA LABORATORIES LP
ERYTHROMYCIN~GEL;TOPICAL~ERYGEL~DELCOR ASSET CORP~2%~N~050617~001~AT~Oct 21, 198
7~Yes~RX~DELCOR ASSET CORP
ERYTHROMYCIN~GEL;TOPICAL~ERYTHROMYCIN~FOUGERA PHARMS~2%~A~064184~001~AT~Sep 30,
ERYTHROMYCIN~GEL;TOPICAL~ERYTHROMYCIN~PERRIGO~2%~A~063211~001~AT~Jan 29, 1993~No
~RX~PERRIGO CO
BENZOYL PEROXIDE; ERYTHROMYCIN~GEL;TOPICAL~ERYTHROMYCIN AND BENZOYL PEROXIDE~TOL
MAR~5%;3%~A~065112~001~AB~Mar 29, 2004~No~RX~TOLMAR INC
ESTRADIOL~GEL;TOPICAL~ESTROGEL~ASCEND THERAPS US~0.06%~N~021166~001~~Feb 9, 2004
~No~DISCN~ASCEND THERAPEUTICS US LLC
AZELAIC ACID~GEL;TOPICAL~FINACEA~BAYER HLTHCARE~15%~N~021470~001~~Dec 24, 2002~Y
es~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
FLUOCINONIDE~GEL;TOPICAL~FLUOCINONIDE~FOUGERA~0.05%~A~072933~001~AB~Dec 30, 1994
~No~RX~E FOUGERA DIV ALTANA INC
FLUOCINONIDE~GEL;TOPICAL~FLUOCINONIDE~TARO~0.05%~A~074935~001~AB~Jul 29, 1997~Ye
s~RX~TARO PHARMACEUTICALS INC
FLUOCINONIDE~GEL;TOPICAL~FLUOCINONIDE~TEVA~0.05%~A~072537~001~AB~Feb 7, 1989~No~
FLUOCINOLONE ACETONIDE~GEL;TOPICAL~FLUONID~ALLERGAN HERBERT~0.025%~A~087300~001~
~May 27, 1982~No~DISCN~ALLERGAN HERBERT DIV ALLERGAN INC
TERBINAFINE~GEL;TOPICAL~LAMISIL~NOVARTIS~1%~N~020846~001~~Apr 29, 1998~No~DISCN~
NOVARTIS CONSUMER HEALTH INC
TERBINAFINE~GEL;TOPICAL~LAMISIL AT~NOVARTIS~1%~N~021958~001~~Jul 24, 2006~Yes~OT
C~NOVARTIS CONSUMER HEALTH INC
FLUOCINONIDE~GEL;TOPICAL~LIDEX~CNTY LINE PHARMS~0.05% **Federal Register determi
nation that product was not discontinued or withdrawn for safety or efficacy rea
sons**~N~017373~001~~Approved Prior to Jan 1, 1982~No~DISCN~COUNTY LINE PHARMACE
UTICALS LLC
CICLOPIROX~GEL;TOPICAL~LOPROX~CNTY LINE PHARMS~0.77%~N~020519~001~AB~Jul 21, 199
7~Yes~RX~COUNTY LINE PHARMACEUTICALS LLC
METRONIDAZOLE~GEL;TOPICAL~METROGEL~GALDERMA LABS LP~0.75%~N~019737~001~AB~Nov 22
, 1988~Yes~RX~GALDERMA LABORATORIES LP
METRONIDAZOLE~GEL;TOPICAL~METROGEL~GALDERMA LABS LP~1%~N~021789~001~AB~Jun 30, 2
METRONIDAZOLE~GEL;TOPICAL~METRONIDAZOLE~FOUGERA PHARMS~0.75%~A~077018~001~AB~Jun
6, 2006~No~RX~FOUGERA PHARMACEUTICALS INC
METRONIDAZOLE~GEL;TOPICAL~METRONIDAZOLE~G AND W LABS INC~0.75%~A~078178~001~AB~J
an 19, 2011~No~RX~G AND W LABORATORIES INC
METRONIDAZOLE~GEL;TOPICAL~METRONIDAZOLE~TARO~0.75%~A~077819~001~AB~Jul 18, 2006~
No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
METRONIDAZOLE~GEL;TOPICAL~METRONIDAZOLE~TOLMAR~0.75%~A~077547~001~AB~Jul 13, 200
6~No~RX~TOLMAR INC
METRONIDAZOLE~GEL;TOPICAL~METRONIDAZOLE~TOLMAR~1%~A~090903~001~AB~Jul 22, 2011~N
o~RX~TOLMAR INC
BRIMONIDINE TARTRATE~GEL;TOPICAL~MIRVASO~GALDERMA LABS LP~EQ 0.33% BASE~N~204708
~001~~Aug 23, 2013~Yes~RX~GALDERMA LABORATORIES LP
NAFTIFINE HYDROCHLORIDE~GEL;TOPICAL~NAFTIN~MERZ PHARMS~1%~N~019356~001~~Jun 18,
1990~Yes~RX~MERZ PHARMACEUTICALS LLC
NAFTIFINE HYDROCHLORIDE~GEL;TOPICAL~NAFTIN~MERZ PHARMS~2%~N~204286~001~~Jun 27,
HYDROCORTISONE~GEL;TOPICAL~NUTRACORT~HEALTHPOINT~1%~A~084698~001~~Approved Prior
to Jan 1, 1982~No~DISCN~HEALTHPOINT LTD
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE~GEL;TOPICAL~ONEXTON~DOW PHARM~3.75%;EQ 1
.2% BASE~N~050819~002~~Nov 24, 2014~Yes~RX~DOW PHARMACEUTICAL SCIENCES

ALITRETINOIN~GEL;TOPICAL~PANRETIN~EISAI INC~EQ 0.1% BASE~N~020886~001~~Feb 2, 19
99~Yes~RX~EISAI INC
HYDROCORTISONE~GEL;TOPICAL~PENECORT~ALLERGAN HERBERT~1%~A~088215~001~~Jun 6, 198
4~No~DISCN~ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC
INGENOL MEBUTATE~GEL;TOPICAL~PICATO~LEO PHARMA AS~0.015%~N~202833~001~~Jan 23, 2
012~No~RX~LEO PHARMA AS
INGENOL MEBUTATE~GEL;TOPICAL~PICATO~LEO PHARMA AS~0.05%~N~202833~002~~Jan 23, 20
12~Yes~RX~LEO PHARMA AS
TRETINOIN~GEL;TOPICAL~RETIN-A~VALEANT INTL~0.01%~N~017955~001~AB~Approved Prior
to Jan 1, 1982~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
TRETINOIN~GEL;TOPICAL~RETIN-A~VALEANT INTL~0.025%~N~017579~002~AB~Approved Prior
to Jan 1, 1982~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
TRETINOIN~GEL;TOPICAL~RETIN-A MICRO~VALEANT INTL~0.04%~N~020475~002~AB~May 10, 2
002~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
TRETINOIN~GEL;TOPICAL~RETIN-A MICRO~VALEANT INTL~0.1%~N~020475~001~AB~Feb 7, 199
TRETINOIN~GEL;TOPICAL~RETIN-A-MICRO~VALEANT INTL~0.08%~N~020475~003~~Jan 28, 201
DICLOFENAC SODIUM~GEL;TOPICAL~SOLARAZE~FOUGERA PHARMS~3%~N~021005~001~AB~Oct 16,
BEXAROTENE~GEL;TOPICAL~TARGRETIN~VALEANT LUXEMBOURG~1%~N~021056~001~~Jun 28, 200
0~Yes~RX~VALEANT PHARMACEUTICALS LUXEMBOURG SARL
TAZAROTENE~GEL;TOPICAL~TAZORAC~ALLERGAN~0.05%~N~020600~001~~Jun 13, 1997~Yes~RX~
ALLERGAN INC
TAZAROTENE~GEL;TOPICAL~TAZORAC~ALLERGAN~0.1%~N~020600~002~~Jun 13, 1997~Yes~RX~A
LLERGAN INC
CLOBETASOL PROPIONATE~GEL;TOPICAL~TEMOVATE~FOUGERA PHARMS~0.05%~N~020337~001~AB~
Apr 29, 1994~Yes~RX~FOUGERA PHARMACEUTICALS INC
DESOXIMETASONE~GEL;TOPICAL~TOPICORT~TARO~0.05%~A~074904~001~AB~Jul 14, 1998~Yes~
RX~TARO PHARMACEUTICALS, INC.
DESOXIMETASONE~GEL;TOPICAL~TOPICORT~TARO PHARMS NORTH~0.05%~N~018586~001~~Mar 29
, 1982~No~DISCN~TARO PHARMACEUTICALS NORTH AMERICA INC
TRETINOIN~GEL;TOPICAL~TRETINOIN~MATAWAN PHARMS~0.01%~A~075589~001~AB~Jun 11, 200
TRETINOIN~GEL;TOPICAL~TRETINOIN~MATAWAN PHARMS~0.025%~A~075529~001~AB~Feb 22, 20
TRETINOIN~GEL;TOPICAL~TRETINOIN~SPEAR PHARMS INC~0.04%~A~202567~001~AB~Jul 17, 2
TRETINOIN~GEL;TOPICAL~TRETINOIN~SPEAR PHARMS INC~0.1%~A~202026~001~AB~Jul 17, 20
BETAMETHASONE BENZOATE~GEL;TOPICAL~UTICORT~PARKE DAVIS~0.025%~N~017244~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
MECHLORETHAMINE HYDROCHLORIDE~GEL;TOPICAL~VALCHLOR~ACTELION PHARMS LTD~EQ 0.016%
BASE~N~202317~001~~Aug 23, 2013~Yes~RX~ACTELION PHARMACEUTICALS LTD
CLINDAMYCIN PHOSPHATE; TRETINOIN~GEL;TOPICAL~VELTIN~STIEFEL GSK~1.2%;0.025%~N~05
0803~001~BX~Jul 16, 2010~Yes~RX~STIEFEL A GSK CO
DICLOFENAC SODIUM~GEL;TOPICAL~VOLTAREN~NOVARTIS~1%~N~022122~001~~Oct 17, 2007~Ye
s~RX~NOVARTIS CONSUMER HEALTH INC
KETOCONAZOLE~GEL;TOPICAL~XOLEGEL~AQUA PHARMS~2%~N~021946~001~~Jul 28, 2006~Yes~R
X~AQUA PHARMACEUTICALS LLC
CLINDAMYCIN PHOSPHATE; TRETINOIN~GEL;TOPICAL~ZIANA~MEDICIS~1.2%;0.025%~N~050802~
001~BX~Nov 7, 2006~Yes~RX~MEDICIS PHARMACEUTICAL CORP
TESTOSTERONE~GEL;TRANSDERMAL~ANDROGEL~ABBVIE~1.62% (20.25MG/1.25GM PACKET)~N~022
309~002~~Sep 7, 2012~No~RX~ABBVIE INC
TESTOSTERONE~GEL;TRANSDERMAL~ANDROGEL~ABBVIE~1.62% (40.5MG/2.5GM PACKET)~N~02230
9~003~~Sep 7, 2012~Yes~RX~ABBVIE INC
TESTOSTERONE~GEL;TRANSDERMAL~ANDROGEL~ABBVIE~25MG/2.5GM PACKET~N~021015~001~AB1~
Feb 28, 2000~No~RX~ABBVIE INC
TESTOSTERONE~GEL;TRANSDERMAL~ANDROGEL~ABBVIE~50MG/5GM PACKET~N~021015~002~AB1~Fe
b 28, 2000~Yes~RX~ABBVIE INC

ESTRADIOL~GEL;TRANSDERMAL~DIVIGEL~VERTICAL PHARMS LLC~0.1% (0.25GM/PACKET)~N~022
038~001~~Jun 4, 2007~No~RX~VERTICAL PHARMACEUTICALS LLC
ESTRADIOL~GEL;TRANSDERMAL~DIVIGEL~VERTICAL PHARMS LLC~0.1% (0.5GM/PACKET)~N~0220
38~002~~Jun 4, 2007~No~RX~VERTICAL PHARMACEUTICALS LLC
ESTRADIOL~GEL;TRANSDERMAL~DIVIGEL~VERTICAL PHARMS LLC~0.1% (1GM/PACKET)~N~022038
~003~~Jun 4, 2007~Yes~RX~VERTICAL PHARMACEUTICALS LLC
OXYBUTYNIN CHLORIDE~GEL;TRANSDERMAL~GELNIQUE~WATSON LABS~10%(100MG/PACKET)~N~022
204~001~~Jan 27, 2009~Yes~RX~WATSON LABORATORIES INC
TESTOSTERONE~GEL;TRANSDERMAL~TESTIM~AUXILIUM PHARMS~50MG/5GM PACKET~N~021454~001
~AB2~Oct 31, 2002~Yes~RX~AUXILIUM PHARMACEUTICALS INC
TESTOSTERONE~GEL;TRANSDERMAL~TESTOSTERONE~PAR PHARM~1% (2.5GM/PACKET)~A~076744~0
01~~May 23, 2007~No~DISCN~PAR PHARMACEUTICAL
TESTOSTERONE~GEL;TRANSDERMAL~TESTOSTERONE~PAR PHARM~1% (5GM/PACKET)~A~076744~002
~~May 23, 2007~No~DISCN~PAR PHARMACEUTICAL
TESTOSTERONE~GEL;TRANSDERMAL~TESTOSTERONE~PERRIGO ISRAEL~25MG/2.5GM PACKET~N~203
098~002~AB1~Jan 31, 2013~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
TESTOSTERONE~GEL;TRANSDERMAL~TESTOSTERONE~PERRIGO ISRAEL~50MG/5GM PACKET~N~20309
8~003~AB1~Jan 31, 2013~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
TESTOSTERONE~GEL;TRANSDERMAL~TESTOSTERONE~TEVA PHARMS~25MG/2.5GM PACKET~N~202763
~001~BX~Feb 14, 2012~No~RX~TEVA PHARMACEUTICALS USA
TESTOSTERONE~GEL;TRANSDERMAL~TESTOSTERONE~TEVA PHARMS~50MG/5GM PACKET~N~202763~0
02~BX~Feb 14, 2012~No~RX~TEVA PHARMACEUTICALS USA
TESTOSTERONE~GEL;TRANSDERMAL~TESTOSTERONE~WATSON LABS~1% (2.5GM/PACKET)~A~076737
~001~~Jan 27, 2006~No~DISCN~WATSON LABORATORIES
TESTOSTERONE~GEL;TRANSDERMAL~TESTOSTERONE~WATSON LABS~1% (5GM/PACKET)~A~076737~0
02~~Jan 27, 2006~No~DISCN~WATSON LABORATORIES
TESTOSTERONE~GEL;TRANSDERMAL~VOGELXO~UPSHER SMITH~50MG/5GM PACKET~N~204399~002~A
B2~Jun 4, 2014~No~RX~UPSHER SMITH LABORATORIES INC
PROGESTERONE~GEL;VAGINAL~CRINONE~ACTAVIS LABS UT INC~4%~N~020701~001~~Jul 31, 19
97~No~RX~ACTAVIS LABORATORIES UT INC
PROGESTERONE~GEL;VAGINAL~CRINONE~ACTAVIS LABS UT INC~8%~N~020701~002~~Jul 31, 19
METRONIDAZOLE~GEL;VAGINAL~METROGEL-VAGINAL~MEDICIS~0.75%~N~020208~001~AB~Aug 17,
1992~Yes~RX~MEDICIS PHARMACEUTICAL CORP
METRONIDAZOLE~GEL;VAGINAL~METRONIDAZOLE~TOLMAR~0.75%~A~077264~001~AB~Oct 31, 200
6~No~RX~TOLMAR INC
METRONIDAZOLE~GEL;VAGINAL~NUVESSA~ACTAVIS LABS UT INC~1.3%~N~205223~001~~Mar 24,
METRONIDAZOLE~GEL;VAGINAL~VANDAZOLE~TEVA PHARMS~0.75%~N~021806~001~BX~May 20, 20
AMINOSALICYLIC ACID~GRANULE, DELAYED RELEASE;ORAL~PASER~JACOBUS~4GM/PACKET~A~074
346~001~~Jun 30, 1994~Yes~RX~JACOBUS PHARMACEUTICAL CO
SODIUM BICARBONATE; TARTARIC ACID~GRANULE, EFFERVESCENT;ORAL~BAROS~MALLINCKRODT
INC~460MG/GM;420MG/GM~N~018509~001~~Aug 7, 1985~No~DISCN~MALLINCKRODT INC
RANITIDINE HYDROCHLORIDE~GRANULE, EFFERVESCENT;ORAL~ZANTAC 150~GLAXO GRP LTD~EQ
150MG BASE/PACKET~N~020251~002~~Mar 31, 1994~No~DISCN~GLAXO GROUP LTD ENGLAND DB
A GLAXOSMITHKLINE
COLESTIPOL HYDROCHLORIDE~GRANULE;ORAL~COLESTID~PHARMACIA AND UPJOHN~5GM/SCOOPFUL
~N~017563~003~AB~Sep 22, 1995~No~RX~PHARMACIA AND UPJOHN CO
COLESTIPOL HYDROCHLORIDE~GRANULE;ORAL~COLESTID~PHARMACIA AND UPJOHN~5GM/PACKET~N
~017563~004~AB~Sep 22, 1995~Yes~RX~PHARMACIA AND UPJOHN CO
COLESTIPOL HYDROCHLORIDE~GRANULE;ORAL~COLESTIPOL HYDROCHLORIDE~IMPAX LABS~5GM/SC
OOPFUL~A~077277~001~AB~May 2, 2006~No~RX~IMPAX LABORATORIES INC
COLESTIPOL HYDROCHLORIDE~GRANULE;ORAL~COLESTIPOL HYDROCHLORIDE~IMPAX LABS~5GM/PA
CKET~A~077277~002~AB~May 2, 2006~No~RX~IMPAX LABORATORIES INC
ERYTHROMYCIN ETHYLSUCCINATE~GRANULE;ORAL~E.E.S.~ARBOR PHARMS LLC~EQ 200MG BASE/5
ML~N~050207~001~AB~Approved Prior to Jan 1, 1982~No~RX~ARBOR PHARMACEUTICALS LLC
ERYTHROMYCIN ETHYLSUCCINATE~GRANULE;ORAL~ERYPED~ARBOR PHARMS LLC~EQ 200MG BASE/5
ML~N~050207~003~AB~Mar 30, 1987~No~RX~ARBOR PHARMACEUTICALS LLC
ERYTHROMYCIN ETHYLSUCCINATE~GRANULE;ORAL~ERYPED~ARBOR PHARMS LLC~EQ 400MG BASE/5

ML~N~050207~002~~Approved Prior to Jan 1, 1982~Yes~RX~ARBOR PHARMACEUTICALS LLC
ERYTHROMYCIN ETHYLSUCCINATE~GRANULE;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~BARR~EQ 200
MG BASE/5ML~A~062055~001~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORI
ES INC
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL~GRANULE;ORAL~ERYTHROMYCIN ETHY
LSUCCINATE AND SULFISOXAZOLE ACETYL~BARR~EQ 200MG BASE/5ML;EQ 600MG BASE/5ML~A~0
62759~001~~May 20, 1988~Yes~RX~BARR LABORATORIES INC
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL~GRANULE;ORAL~ERYZOLE~ALRA~EQ 2
00MG BASE/5ML;EQ 600MG BASE/5ML~A~062758~001~~Jun 15, 1988~No~DISCN~ALRA LABORAT
ORIES INC
COLESTIPOL HYDROCHLORIDE~GRANULE;ORAL~FLAVORED COLESTID~PHARMACIA AND UPJOHN~5GM
/PACKET~N~017563~001~~Approved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN C
O
COLESTIPOL HYDROCHLORIDE~GRANULE;ORAL~FLAVORED COLESTID~PHARMACIA AND UPJOHN~5GM
/SCOOPFUL~N~017563~002~~Approved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN
CO
TERBINAFINE HYDROCHLORIDE~GRANULE;ORAL~LAMISIL~NOVARTIS~EQ 125MG BASE/PACKET~N~0
22071~001~~Sep 28, 2007~No~RX~NOVARTIS PHARMACEUTICALS CORP
TERBINAFINE HYDROCHLORIDE~GRANULE;ORAL~LAMISIL~NOVARTIS~EQ 187.5MG BASE/PACKET~N
~022071~002~~Sep 28, 2007~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
MONTELUKAST SODIUM~GRANULE;ORAL~MONTELUKAST SODIUM~DR REDDYS LABS LTD~EQ 4MG BAS
E/PACKET~A~202906~001~AB~Sep 17, 2012~No~RX~DR REDDYS LABORATORIES LTD
MONTELUKAST SODIUM~GRANULE;ORAL~MONTELUKAST SODIUM~MYLAN PHARMS INC~EQ 4MG BASE/
PACKET~A~202776~001~AB~Dec 18, 2012~No~RX~MYLAN PHARMACEUTICALS INC
MONTELUKAST SODIUM~GRANULE;ORAL~MONTELUKAST SODIUM~TEVA PHARMS~EQ 4MG BASE/PACKE
T~A~090955~001~AB~Aug 3, 2012~No~RX~TEVA PHARMACEUTICALS USA
IPODATE CALCIUM~GRANULE;ORAL~ORAGRAFIN CALCIUM~BRACCO~3GM/PACKET~N~012968~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
ERYTHROMYCIN ETHYLSUCCINATE~GRANULE;ORAL~PEDIAMYCIN~ROSS LABS~EQ 200MG BASE/5ML~
A~062305~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROSS LABORATORIES DIV ABBOT
T LABORATORIES INC
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL~GRANULE;ORAL~PEDIAZOLE~ROSS LA
BS~EQ 200MG BASE/5ML;EQ 600MG BASE/5ML~N~050529~001~~Approved Prior to Jan 1, 19
82~No~DISCN~ROSS LABORATORIES DIV ABBOTT LABORATORIES INC
MONTELUKAST SODIUM~GRANULE;ORAL~SINGULAIR~MERCK~EQ 4MG BASE/PACKET~N~021409~001~
AB~Jul 26, 2002~Yes~RX~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICORETTE~GLAXOSMITHKLINE~EQ 2MG BASE~N~
018612~002~~Feb 9, 1996~Yes~OTC~GLAXOSMITHKLINE
018612~004~~Sep 25, 2000~No~OTC~GLAXOSMITHKLINE
020066~002~~Feb 9, 1996~Yes~OTC~GLAXOSMITHKLINE
020066~004~~Sep 25, 2000~No~OTC~GLAXOSMITHKLINE
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICORETTE (MINT)~GLAXOSMITHKLINE~EQ 2MG
BASE~N~018612~003~~Dec 23, 1998~No~OTC~GLAXOSMITHKLINE
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICORETTE (MINT)~GLAXOSMITHKLINE~EQ 4MG
BASE~N~020066~003~~Dec 23, 1998~No~OTC~GLAXOSMITHKLINE
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICOTINE POLACRILEX~ACTAVIS LABS NY INC~
EQ 2MG BASE~A~074507~001~~Mar 15, 1999~No~OTC~ACTAVIS LABORATORIES NY INC
EQ 2MG BASE~A~076568~001~~Jul 29, 2004~No~DISCN~ACTAVIS LABORATORIES NY INC
EQ 2MG BASE~A~076569~001~~Jul 29, 2004~No~OTC~ACTAVIS LABORATORIES NY INC
EQ 2MG BASE~A~078699~001~~Dec 29, 2008~No~OTC~ACTAVIS LABORATORIES NY INC
EQ 4MG BASE~A~074707~001~~Mar 19, 1999~No~OTC~ACTAVIS LABORATORIES NY INC

EQ 4MG BASE~A~076569~002~~Jul 29, 2004~No~DISCN~ACTAVIS LABORATORIES NY INC
EQ 4MG BASE~A~078697~001~~Dec 29, 2008~No~OTC~ACTAVIS LABORATORIES NY INC
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICOTINE POLACRILEX~IVAX SUB TEVA PHARMS
~EQ 2MG BASE~A~076880~001~~Feb 18, 2009~No~OTC~IVAX PHARMACEUTICALS INC SUB TEVA
PHARMACEUTICALS USA
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICOTINE POLACRILEX~IVAX SUB TEVA PHARMS
~EQ 4MG BASE~A~077850~001~~Feb 18, 2009~No~OTC~IVAX PHARMACEUTICALS INC SUB TEVA
PHARMACEUTICALS USA
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICOTINE POLACRILEX~PERRIGO~EQ 2MG BASE~
A~076775~001~~Sep 16, 2004~No~OTC~PERRIGO CO
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICOTINE POLACRILEX~PERRIGO R AND D~EQ 2
MG BASE~A~078325~001~~Oct 30, 2006~No~OTC~PERRIGO R AND D CO
MG BASE~A~078547~001~~May 24, 2007~No~OTC~PERRIGO R AND D CO
MG BASE~A~078967~001~~Apr 23, 2008~No~OTC~PERRIGO R AND D CO
MG BASE~A~091349~001~~Jul 20, 2011~No~OTC~PERRIGO R AND D CO
MG BASE~A~078546~001~~May 24, 2007~No~OTC~PERRIGO R AND D CO
MG BASE~A~078968~001~~Apr 23, 2008~No~OTC~PERRIGO R AND D CO
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~NICOTINE POLACRILEX~WATSON LABS~EQ 2MG B
ASE~A~079044~001~~Jul 8, 2009~No~OTC~WATSON LABORATORIES INC
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~THRIVE~NOVARTIS~EQ 2MG BASE~A~077658~001
~~Jun 19, 2007~No~OTC~NOVARTIS CONSUMER HEALTH INC
NICOTINE POLACRILEX~GUM, CHEWING;BUCCAL~THRIVE~NOVARTIS~EQ 4MG BASE~A~077656~001
~~Jun 19, 2007~No~OTC~NOVARTIS CONSUMER HEALTH INC
ETONOGESTREL~IMPLANT;IMPLANTATION~IMPLANON~ORGANON USA INC~68MG/IMPLANT~N~021529
~001~~Jul 17, 2006~Yes~RX~ORGANON USA INC
LEVONORGESTREL~IMPLANT;IMPLANTATION~JADELLE~POPULATION COUNCIL~75MG/IMPLANT **Fe
deral Register determination that product was not discontinued or withdrawn for
safety or efficacy reasons**~N~020544~001~~Nov 1, 1996~No~DISCN~POPULATION COUNC
IL CENTER FOR BIOMEDICAL RESEARCH
LEVONORGESTREL~IMPLANT;IMPLANTATION~LEVONORGESTREL~WYETH PHARMS INC~75MG/IMPLANT
~N~020627~001~~Aug 15, 1996~No~DISCN~WYETH PHARMACEUTICALS INC
ETONOGESTREL~IMPLANT;IMPLANTATION~NEXPLANON~ORGANON USA INC~68MG/IMPLANT~N~02152
9~002~~May 31, 2011~Yes~RX~ORGANON USA INC

LEVONORGESTREL~IMPLANT;IMPLANTATION~NORPLANT~POPULATION COUNCIL~36MG/IMPLANT~N~0
19897~001~~Dec 10, 1990~No~DISCN~POPULATION COUNCIL
LEVONORGESTREL~IMPLANT;IMPLANTATION~NORPLANT SYSTEM IN PLASTIC CONTAINER~WYETH P
HARMS INC~36MG/IMPLANT~N~020088~001~~Dec 10, 1990~No~DISCN~WYETH PHARMACEUTICALS
INC
LEUPROLIDE ACETATE~IMPLANT;IMPLANTATION~VIADUR~ORTHO MCNEIL JANSSEN~EQ 65MG BASE
~N~021088~001~~Mar 3, 2000~No~DISCN~ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC
GANCICLOVIR~IMPLANT;IMPLANTATION~VITRASERT~BAUSCH AND LOMB~4.5MG~N~020569~001~~M
ar 4, 1996~No~DISCN~BAUSCH AND LOMB INC
GOSERELIN ACETATE~IMPLANT;IMPLANTATION~ZOLADEX~ASTRAZENECA~EQ 3.6MG BASE~N~01972
6~001~~Dec 29, 1989~Yes~RX~ASTRAZENECA UK LTD
GOSERELIN ACETATE~IMPLANT;IMPLANTATION~ZOLADEX~ASTRAZENECA~EQ 10.8MG BASE~N~0205
78~001~~Jan 11, 1996~Yes~RX~ASTRAZENECA UK LTD
CARMUSTINE~IMPLANT;INTRACRANIAL~GLIADEL~ARBOR PHARMS LLC~7.7MG~N~020637~001~~Sep
23, 1996~Yes~RX~ARBOR PHARMACEUTICALS LLC
FLUOCINOLONE ACETONIDE~IMPLANT;INTRAVITREAL~ILUVIEN~ALIMERA SCIENCES INC~0.19MG~
N~201923~001~~Sep 26, 2014~Yes~RX~ALIMERA SCIENCES INC
DEXAMETHASONE~IMPLANT;INTRAVITREAL~OZURDEX~ALLERGAN~0.7MG~N~022315~001~~Jun 17,
FLUOCINOLONE ACETONIDE~IMPLANT;INTRAVITREAL~RETISERT~BAUSCH AND LOMB~0.59MG~N~02
1737~001~~Apr 8, 2005~Yes~RX~BAUSCH AND LOMB INC
HISTRELIN ACETATE~IMPLANT;SUBCUTANEOUS~SUPPRELIN LA~ENDO PHARM~50MG~N~022058~001
~~May 3, 2007~Yes~RX~ENDO PHARMACEUTICAL SOLUTIONS INC
HISTRELIN ACETATE~IMPLANT;SUBCUTANEOUS~VANTAS~ENDO PHARM~50MG~N~021732~001~~Oct
12, 2004~Yes~RX~ENDO PHARMACEUTICAL SOLUTIONS INC
NICOTINE~INHALANT;ORAL~NICOTROL~PHARMACIA AND UPJOHN~4MG/CARTRIDGE~N~020714~001~
~May 2, 1997~Yes~RX~PHARMACIA AND UPJOHN CO
AMPHOTERICIN B~INJECTABLE, LIPID COMPLEX;INJECTION~ABELCET~SIGMA TAU~5MG/ML~N~05
0724~001~~Nov 20, 1995~Yes~RX~SIGMA TAU PHARMACEUTICALS INC
AMPHOTERICIN B~INJECTABLE, LIPID COMPLEX;INJECTION~AMPHOTEC~ALKOPHARMA USA~50MG/
VIAL~N~050729~001~~Nov 22, 1996~Yes~RX~ALKOPHARMA USA INC
AMPHOTERICIN B~INJECTABLE, LIPID COMPLEX;INJECTION~AMPHOTEC~ALKOPHARMA USA~100MG
/VIAL~N~050729~002~~Nov 22, 1996~Yes~RX~ALKOPHARMA USA INC
MORPHINE SULFATE~INJECTABLE, LIPOSOMAL;EPIDURAL~DEPODUR~PACIRA PHARMS INC~10MG/M
L (10MG/ML)~N~021671~001~~May 18, 2004~No~DISCN~PACIRA PHARMACEUTICALS INC
MORPHINE SULFATE~INJECTABLE, LIPOSOMAL;EPIDURAL~DEPODUR~PACIRA PHARMS INC~15MG/1
.5ML (10MG/ML)~N~021671~002~~May 18, 2004~No~DISCN~PACIRA PHARMACEUTICALS INC
MORPHINE SULFATE~INJECTABLE, LIPOSOMAL;EPIDURAL~DEPODUR~PACIRA PHARMS INC~20MG/2
ML (10MG/ML)~N~021671~003~~May 18, 2004~No~DISCN~PACIRA PHARMACEUTICALS INC
AMPHOTERICIN B~INJECTABLE, LIPOSOMAL;INJECTION~AMBISOME~ASTELLAS~50MG/VIAL~N~050
740~001~~Aug 11, 1997~Yes~RX~ASTELLAS PHARMA US INC
DAUNORUBICIN CITRATE~INJECTABLE, LIPOSOMAL;INJECTION~DAUNOXOME~GALEN (UK)~EQ 2MG
BASE/ML~N~050704~002~~Apr 8, 1996~Yes~RX~GALEN LTD
CYTARABINE~INJECTABLE, LIPOSOMAL;INJECTION~DEPOCYT~PACIRA PHARMS INC~10MG/ML~N~0
21041~001~~Apr 1, 1999~Yes~RX~PACIRA PHARMACEUTICALS INC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE, LIPOSOMAL;INJECTION~DOXIL (LIPOSOMAL)~JANS
SEN RES AND DEV~20MG/10ML (2MG/ML)~N~050718~001~AB~Nov 17, 1995~No~RX~JANSSEN RE
SEARCH AND DEVELOPMENT LLC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE, LIPOSOMAL;INJECTION~DOXIL (LIPOSOMAL)~JANS
SEN RES AND DEV~50MG/25ML (2MG/ML)~N~050718~002~AB~Jun 13, 2000~No~RX~JANSSEN RE
SEARCH AND DEVELOPMENT LLC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE, LIPOSOMAL;INJECTION~DOXORUBICIN HYDROCHLOR
IDE (LIPOSOMAL)~SUN PHARMA GLOBAL~20MG/10ML (2MG/ML)~A~203263~001~AB~Feb 4, 2013
~Yes~RX~SUN PHARMA GLOBAL FZE
DOXORUBICIN HYDROCHLORIDE~INJECTABLE, LIPOSOMAL;INJECTION~DOXORUBICIN HYDROCHLOR
IDE (LIPOSOMAL)~SUN PHARMA GLOBAL~50MG/25ML (2MG/ML)~A~203263~002~AB~Feb 4, 2013
~Yes~RX~SUN PHARMA GLOBAL FZE
BUPIVACAINE~INJECTABLE, LIPOSOMAL;INJECTION~EXPAREL~PACIRA PHARMS INC~133MG/10ML
(13.3MG/ML)~N~022496~001~~Oct 28, 2011~No~DISCN~PACIRA PHARMACEUTICALS INC
BUPIVACAINE~INJECTABLE, LIPOSOMAL;INJECTION~EXPAREL~PACIRA PHARMS INC~266MG/20ML

(13.3MG/ML)~N~022496~002~~Oct 28, 2011~Yes~RX~PACIRA PHARMACEUTICALS INC
VINCRISTINE SULFATE~INJECTABLE, LIPOSOMAL;INTRAVENOUS~MARQIBO KIT~TALON THERAP~5
MG/5ML (1MG/ML)~N~202497~001~~Aug 9, 2012~Yes~RX~TALON THERAPEUTICS INC
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE~INJECTABLE, TABLET;INTRAMUSCULAR, ORAL
~LUPANETA PACK~ABBVIE ENDOCRINE~3.75MG/VIAL,N/A;N/A,5MG~N~203696~001~~Dec 14, 20
12~No~RX~ABBVIE ENDOCRINE INC
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE~INJECTABLE, TABLET;INTRAMUSCULAR, ORAL
~LUPANETA PACK~ABBVIE ENDOCRINE~11.25MG/VIAL,N/A;N/A,5MG~N~203696~002~~Dec 14, 2
012~Yes~RX~ABBVIE ENDOCRINE INC
HYDROCORTISONE SODIUM SUCCINATE~INJECTABLE;INJECTION~A-HYDROCORT~ABBOTT~EQ 1GM B
ASE/VIAL~A~089580~001~~Apr 11, 1989~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS D
IV
HYDROCORTISONE SODIUM SUCCINATE~INJECTABLE;INJECTION~A-HYDROCORT~ABBOTT~EQ 100MG
BASE/VIAL~A~085928~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATOR
IES PHARMACEUTICAL PRODUCTS DIV
BASE/VIAL~A~089577~001~~Apr 11, 1989~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS
DIV
DIV
DIV
HYDROCORTISONE SODIUM SUCCINATE~INJECTABLE;INJECTION~A-HYDROCORT~HOSPIRA~EQ 1GM
BASE/VIAL~A~085932~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA WORLDWIDE
, INC
HYDROCORTISONE SODIUM SUCCINATE~INJECTABLE;INJECTION~A-HYDROCORT~HOSPIRA~EQ 100M
G BASE/VIAL~A~040666~001~AP~Apr 6, 2006~No~RX~HOSPIRA INC
G BASE/VIAL~A~085929~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
G BASE/VIAL~A~085930~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA WORLDWI
DE, INC
G BASE/VIAL~A~085931~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA WORLDWI
DE, INC
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~A-METHAPRED~ABBOTT~EQ 1
GM BASE/VIAL~A~089576~001~~Feb 22, 1991~No~DISCN~ABBOTT LABORATORIES HOSP PRODUC
TS DIV
0MG BASE/VIAL~A~089573~001~~Feb 22, 1991~No~DISCN~ABBOTT LABORATORIES HOSP PRODU
CTS DIV
25MG BASE/VIAL~A~089574~001~~Feb 22, 1991~No~DISCN~ABBOTT LABORATORIES HOSP PROD
UCTS DIV
00MG BASE/VIAL~A~089575~001~~Feb 22, 1991~No~DISCN~ABBOTT LABORATORIES HOSP PROD
UCTS DIV
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~A-METHAPRED~HOSPIRA~EQ
1GM BASE/VIAL~A~085852~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
1GM BASE/VIAL~A~089174~001~~Aug 18, 1987~No~DISCN~HOSPIRA WORLDWIDE, INC
40MG BASE/VIAL~A~040664~001~AP~Dec 20, 2005~No~RX~HOSPIRA INC
40MG BASE/VIAL~A~085853~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
125MG BASE/VIAL~A~040665~001~AP~Dec 20, 2005~No~RX~HOSPIRA INC

500MG BASE/VIAL~A~089173~001~~Aug 18, 1987~No~DISCN~HOSPIRA WORLDWIDE, INC
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~A-METHAPRED~HOSPIRA INC
~EQ 40MG BASE/VIAL~A~040793~001~AP~Nov 25, 2008~No~RX~HOSPIRA INC
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~A-METHAPRED~HOSPIRA INC
~EQ 125MG BASE/VIAL~A~040827~001~AP~Nov 25, 2008~No~RX~HOSPIRA INC
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT~INJECTABLE;INJECTION~A-N STANNOUS AGGRE
GATED ALBUMIN~SYNCOR PHARMS~N/A~N~017916~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~SYNCOR PHARMACEUTICALS INC
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~A.P.L.~FERRING~5,000 UNITS/VIAL~N~0
17055~001~~Approved Prior to Jan 1, 1982~No~DISCN~FERRING PHARMACEUTICALS INC
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~A.P.L.~FERRING~10,000 UNITS/VIAL~N~
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~A.P.L.~FERRING~20,000 UNITS/VIAL~N~
METHOTREXATE SODIUM~INJECTABLE;INJECTION~ABITREXATE~ABIC~EQ 25MG BASE/ML~A~08916
1~001~~Mar 10, 1987~No~DISCN~ABIC LTD
METHOTREXATE SODIUM~INJECTABLE;INJECTION~ABITREXATE~ABIC~EQ 50MG BASE/VIAL~A~089
354~001~~Jul 17, 1987~No~DISCN~ABIC LTD
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~ACCRETROPIN~EMERGENT~5MG/ML (5MG/ML)
~N~021538~001~~Jan 23, 2008~No~DISCN~EMERGENT BIOSOLUTIONS INC
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~N~018725~001~~Nov 29, 1982~No~DISCN~B BRAUN MEDICAL INC
ACETAZOLAMIDE SODIUM~INJECTABLE;INJECTION~ACETAZOLAMIDE SODIUM~EUROHLTH INTL SAR
L~EQ 500MG BASE/VIAL~A~040089~001~AP~Feb 28, 1995~No~RX~EUROHEALTH INTERNATIONAL
SARL
ACETAZOLAMIDE SODIUM~INJECTABLE;INJECTION~ACETAZOLAMIDE SODIUM~HOSPIRA~EQ 500MG
BASE/VIAL~A~040108~001~~Oct 30, 1995~No~DISCN~HOSPIRA INC
ACETAZOLAMIDE SODIUM~INJECTABLE;INJECTION~ACETAZOLAMIDE SODIUM~SAGENT AGILA~EQ 5
00MG BASE/VIAL~A~200880~001~AP~May 9, 2012~No~RX~SAGENT AGILA LLC
ACETAZOLAMIDE SODIUM~INJECTABLE;INJECTION~ACETAZOLAMIDE SODIUM~X GEN PHARMS~EQ 5
00MG BASE/VIAL~A~040784~001~AP~Dec 10, 2008~Yes~RX~X GEN PHARMACEUTICALS INC
ACETAZOLAMIDE SODIUM~INJECTABLE;INJECTION~ACETAZOLAMIDE SODIUM ~EMCURE PHARMS LT
D~EQ 500MG BASE/VIAL~A~202693~001~AP~Dec 19, 2014~No~RX~EMCURE PHARMACEUTICALS L
TD
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~ACHROMYC
IN~LEDERLE~40MG/VIAL;100MG/VIAL~N~050276~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~ACHROMYC
IN~LEDERLE~40MG/VIAL;250MG/VIAL~N~050276~003~~Approved Prior to Jan 1, 1982~No~D
TETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~ACHROMYCIN~LEDERLE~250MG/VIAL~N~
050273~002~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMER
ICAN CYANAMID CO
TETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~ACHROMYCIN~LEDERLE~500MG/VIAL~N~
ICAN CYANAMID CO
ARGATROBAN~INJECTABLE;INJECTION~ACOVA~PFIZER~250MG/2.5ML (100MG/ML)~N~020883~001
~AP~Jun 30, 2000~Yes~RX~PFIZER INC
CORTICOTROPIN~INJECTABLE;INJECTION~ACTH~PARKEDALE~25 UNITS/VIAL~N~008317~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
CORTICOTROPIN~INJECTABLE;INJECTION~ACTH~PARKEDALE~40 UNITS/VIAL~N~008317~004~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
CORTICOTROPIN~INJECTABLE;INJECTION~ACTHAR~SANOFI AVENTIS US~25 UNITS/VIAL~N~0075
CORTICOTROPIN~INJECTABLE;INJECTION~ACTHAR~SANOFI AVENTIS US~40 UNITS/VIAL~N~0075
SERACTIDE ACETATE~INJECTABLE;INJECTION~ACTHAR GEL-SYNTHETIC~ARMOUR PHARM~40 UNIT
S/ML~N~017861~001~~Approved Prior to Jan 1, 1982~No~DISCN~ARMOUR PHARMACEUTICAL
CO
SERACTIDE ACETATE~INJECTABLE;INJECTION~ACTHAR GEL-SYNTHETIC~ARMOUR PHARM~80 UNIT
S/ML~N~017861~002~~Approved Prior to Jan 1, 1982~No~DISCN~ARMOUR PHARMACEUTICAL
CO
CORTICORELIN OVINE TRIFLUTATE~INJECTABLE;INJECTION~ACTHREL~FERRING~EQ 0.1MG BASE
/VIAL~N~020162~001~~May 23, 1996~Yes~RX~FERRING PHARMACEUTICALS INC
TECHNETIUM TC-99M APCITIDE~INJECTABLE;INJECTION~ACUTECT~CIS BIO INTL SA~N/A~N~02
0887~001~~Sep 14, 1998~No~DISCN~CIS BIO INTERNATIONAL SA
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR~ABBVIE~EQ 50MG BASE/ML~A~075114~
001~~Jul 26, 1999~No~DISCN~ABBVIE INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVA
TIVE FREE~HIKMA MAPLE ~EQ 1GM BASE/VIAL~A~074885~002~~Dec 19, 1997~No~RX~HIKMA M
APLE LTD
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVA
TIVE FREE~HIKMA MAPLE ~EQ 500MG BASE/VIAL~A~074885~001~~Dec 19, 1997~Yes~RX~HIKM
A MAPLE LTD
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~APOTHECON~EQ 1GM BASE/VIA
L~A~074897~002~~Feb 27, 1998~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~APOTHECON~EQ 500MG BASE/V
IAL~A~074897~001~~Feb 27, 1998~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~AUROBINDO PHARMA LTD~EQ 5
0MG BASE/ML~A~203701~001~AP~Oct 11, 2013~No~RX~AUROBINDO PHARMA LTD
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~BEDFORD~EQ 1GM BASE/VIAL~
A~074596~001~~Apr 22, 1997~Yes~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIE
S INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~BEDFORD~EQ 500MG BASE/VIA
L~A~074596~002~AP~Apr 22, 1997~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATO
RIES INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~FRESENIUS KABI USA~EQ 50M
G BASE/ML~A~074930~001~AP~May 13, 1998~Yes~RX~FRESENIUS KABI USA LLC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~FRESENIUS KABI USA~EQ 500
MG BASE/VIAL~A~075015~001~AP~Apr 30, 1998~Yes~RX~FRESENIUS KABI USA LLC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~HIKMA MAPLE ~EQ 1GM BASE/
VIAL~A~074913~002~~Oct 15, 1997~No~DISCN~HIKMA MAPLE LTD
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~HIKMA MAPLE ~EQ 500MG BAS
E/VIAL~A~074913~001~~Oct 15, 1997~No~DISCN~HIKMA MAPLE LTD
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~HOSPIRA~EQ 1GM BASE/VIAL~
A~074663~002~~Apr 22, 1997~No~DISCN~HOSPIRA INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~HOSPIRA~EQ 1GM BASE/VIAL~
A~074758~002~~Apr 22, 1997~No~DISCN~HOSPIRA INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~HOSPIRA~EQ 25MG BASE/ML~A
~074720~001~~Apr 22, 1997~No~DISCN~HOSPIRA WORLDWIDE, INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~HOSPIRA~EQ 50MG BASE/ML~A
~075065~001~~Feb 25, 1999~No~DISCN~HOSPIRA WORLDWIDE, INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~HOSPIRA~EQ 500MG BASE/VIA
L~A~074663~001~~Apr 22, 1997~No~DISCN~HOSPIRA INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~HOSPIRA~EQ 500MG BASE/VIA
L~A~074758~001~~Apr 22, 1997~No~DISCN~HOSPIRA INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~TEVA PARENTERAL~EQ 1GM BA
SE/VIAL~A~074969~002~~Aug 26, 1997~No~DISCN~TEVA PARENTERAL MEDICINES INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~TEVA PARENTERAL~EQ 50MG B
ASE/ML~A~075627~001~~Mar 28, 2001~No~DISCN~TEVA PARENTERAL MEDICINES INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ACYCLOVIR SODIUM~TEVA PARENTERAL~EQ 500MG

BASE/VIAL~A~074969~001~~Aug 26, 1997~No~DISCN~TEVA PARENTERAL MEDICINES INC
PEGADEMASE BOVINE~INJECTABLE;INJECTION~ADAGEN~SIGMA TAU~250 UNITS/ML~N~019818~00
1~~Mar 21, 1990~Yes~RX~SIGMA TAU PHARMACEUTICALS INC
ADENOSINE~INJECTABLE;INJECTION~ADENOCARD~ASTELLAS~3MG/ML~N~019937~002~AP~Oct 30,
1989~Yes~RX~ASTELLAS PHARMA US INC
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~AGILA SPECLTS~3MG/ML~A~078640~001~AP~Ma
r 21, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~AGILA SPECLTS~3MG/ML~A~078686~001~AP~Ma
y 13, 2009~No~RX~AGILA SPECIALTIES PRIVATE LTD
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~AKORN~3MG/ML~A~078076~001~AP~Oct 31, 20
08~No~RX~AKORN INC
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~BEDFORD~3MG/ML~A~076404~001~AP~Jun 16,
2004~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~FRESENIUS KABI USA~3MG/ML~A~077133~001~
AP~Apr 27, 2005~No~RX~FRESENIUS KABI USA LLC
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~GLAND PHARMA LTD~3MG/ML~A~077283~001~AP
~Jun 14, 2007~No~RX~GLAND PHARMA LTD
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~HIKMA MAPLE ~3MG/ML~A~076500~001~AP~Jun
16, 2004~No~RX~HIKMA MAPLE LTD
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~HIKMA MAPLE ~3MG/ML~A~076501~001~~Jun 1
6, 2004~No~DISCN~HIKMA MAPLE LTD
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~LUITPOLD~3MG/ML~A~090010~001~AP~Apr 28,
2009~No~RX~LUITPOLD PHARMACEUTICALS INC
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~TEVA PHARMS USA~3MG/ML~A~076564~001~~Ju
n 16, 2004~No~DISCN~TEVA PHARMACEUTICALS USA
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~TEVA PHARMS USA~3MG/ML~A~078676~001~~Ju
l 31, 2008~No~DISCN~TEVA PHARMACEUTICALS USA
ADENOSINE~INJECTABLE;INJECTION~ADENOSINE~WOCKHARDT~3MG/ML~A~090220~001~AP~Jul 20
, 2009~No~RX~WOCKHARDT LTD
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~ADRIAMYCIN PFS~PHARMACIA AND UPJO
HN~2MG/ML~A~063165~001~~Jan 30, 1991~No~DISCN~PHARMACIA AND UPJOHN CO
HN~2MG/ML~N~050629~001~~Dec 23, 1987~No~DISCN~PHARMACIA AND UPJOHN CO
HN~200MG/100ML~A~063165~002~~Jan 30, 1991~No~DISCN~PHARMACIA AND UPJOHN CO
HN~200MG/100ML~N~050629~002~~May 3, 1988~No~DISCN~PHARMACIA AND UPJOHN CO
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~ADRIAMYCIN RDF~PHARMACIA AND UPJO
HN~10MG/VIAL~N~050467~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND
UPJOHN CO
HN~20MG/VIAL~N~050467~003~~May 20, 1985~No~DISCN~PHARMACIA AND UPJOHN CO
HN~50MG/VIAL~N~050467~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND
UPJOHN CO
HN~150MG/VIAL~N~050467~004~~Jul 22, 1987~No~DISCN~PHARMACIA AND UPJOHN CO
FLUOROURACIL~INJECTABLE;INJECTION~ADRUCIL~PHARMACIA AND UPJOHN~50MG/ML~A~081222~
001~~Jun 28, 1991~No~DISCN~PHARMACIA AND UPJOHN CO
FLUOROURACIL~INJECTABLE;INJECTION~ADRUCIL~PHARMACIA AND UPJOHN~50MG/ML~N~017959~
FLUOROURACIL~INJECTABLE;INJECTION~ADRUCIL~TEVA PARENTERAL~50MG/ML~A~040023~001~~
Oct 18, 1991~No~DISCN~TEVA PARENTERAL MEDICINES INC
FLUOROURACIL~INJECTABLE;INJECTION~ADRUCIL~TEVA PARENTERAL~50MG/ML~A~081225~001~~
Aug 28, 1991~No~DISCN~TEVA PARENTERAL MEDICINES INC
POLYMYXIN B SULFATE~INJECTABLE;INJECTION~AEROSPORIN~GLAXOSMITHKLINE~EQ 500,000 U
BASE/VIAL~A~062036~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
TIROFIBAN HYDROCHLORIDE~INJECTABLE;INJECTION~AGGRASTAT~MEDICURE~EQ 5MG BASE/100M
L (EQ 0.05MG BASE/ML)~N~020913~002~~May 17, 2002~No~RX~MEDICURE INTERNATIONAL IN
C
TIROFIBAN HYDROCHLORIDE~INJECTABLE;INJECTION~AGGRASTAT~MEDICURE~EQ 12.5MG BASE/5
0ML (EQ 0.25MG BASE/ML)~N~020912~001~~May 14, 1998~No~DISCN~MEDICURE INTERNATION
AL INC
TIROFIBAN HYDROCHLORIDE~INJECTABLE;INJECTION~AGGRASTAT~MEDICURE~EQ 12.5MG BASE/2
50ML (EQ 0.05MG BASE/ML)~N~020913~003~~Apr 20, 2000~Yes~RX~MEDICURE INTERNATIONA
L INC
TIROFIBAN HYDROCHLORIDE~INJECTABLE;INJECTION~AGGRASTAT~MEDICURE~EQ 25MG BASE/500
ML (EQ 0.05MG BASE/ML)~N~020913~001~~May 14, 1998~No~DISCN~MEDICURE INTERNATIONA
L INC
BIPERIDEN LACTATE~INJECTABLE;INJECTION~AKINETON~ABBVIE~5MG/ML~N~012418~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ABBVIE INC
ALCOHOL; DEXTROSE~INJECTABLE;INJECTION~ALCOHOL 10% AND DEXTROSE 5%~B BRAUN~10ML/
100ML;5GM/100ML~N~004589~006~~Approved Prior to Jan 1, 1982~Yes~RX~B BRAUN MEDIC
AL INC
ALCOHOL; DEXTROSE~INJECTABLE;INJECTION~ALCOHOL 5% AND DEXTROSE 5%~B BRAUN~5ML/10
0ML;5GM/100ML~N~004589~004~AP~Approved Prior to Jan 1, 1982~Yes~RX~B BRAUN MEDIC
AL INC
ALCOHOL; DEXTROSE~INJECTABLE;INJECTION~ALCOHOL 5% IN D5-W~HOSPIRA~5ML/100ML;5GM/
100ML~A~083263~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA WORLDWIDE, IN
C
ALCOHOL~INJECTABLE;INJECTION~ALCOHOL 5% IN DEXTROSE 5%~MILES~5ML/100ML~A~083483~
001~~Approved Prior to Jan 1, 1982~No~DISCN~MILES LABORATORIES INC
ALCOHOL; DEXTROSE~INJECTABLE;INJECTION~ALCOHOL 5% IN DEXTROSE 5% IN WATER~BAXTER
HLTHCARE~5ML/100ML;5GM/100ML~A~083256~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~BAXTER HEALTHCARE CORP
METHYLDOPATE HYDROCHLORIDE~INJECTABLE;INJECTION~ALDOMET~MERCK~50MG/ML~N~013401~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
ALFENTANIL HYDROCHLORIDE~INJECTABLE;INJECTION~ALFENTA~AKORN~EQ 0.5MG BASE/ML~N~0
19353~001~AP~Dec 29, 1986~Yes~RX~AKORN INC
ALFENTANIL HYDROCHLORIDE~INJECTABLE;INJECTION~ALFENTANIL~HOSPIRA~EQ 0.5MG BASE/M
L~A~075221~001~AP~Oct 28, 1999~No~RX~HOSPIRA INC
MELPHALAN HYDROCHLORIDE~INJECTABLE;INJECTION~ALKERAN~GLAXOSMITHKLINE~EQ 50MG BAS
E/VIAL~N~020207~001~AP~Nov 18, 1992~Yes~RX~GLAXOSMITHKLINE
ALLOPURINOL SODIUM~INJECTABLE;INJECTION~ALLOPURINOL SODIUM~EUROHLTH INTL SARL~EQ
500MG BASE/VIAL~A~076870~001~AP~Aug 26, 2004~No~RX~EUROHEALTH INTERNATIONAL SAR
L
ALLOPURINOL SODIUM~INJECTABLE;INJECTION~ALOPRIM~MYLAN INSTITUTIONAL~EQ 500MG BAS
E/VIAL~N~020298~001~AP~May 17, 1996~Yes~RX~MYLAN INSTITUTIONAL LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ALPHACAINE HYDROCHLORIDE~CARLISLE~2
%~A~084721~001~~Approved Prior to Jan 1, 1982~No~DISCN~CARLISLE LABORATORIES INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ALPHACAINE HYDROCHLORI
DE W/ EPINEPHRINE~CARLISLE~0.01MG/ML;2%~A~084720~001~~Approved Prior to Jan 1, 1
982~No~DISCN~CARLISLE LABORATORIES INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ALPHACAINE HYDROCHLORI
DE W/ EPINEPHRINE~CARLISLE~0.02MG/ML;2%~A~084732~001~~Approved Prior to Jan 1, 1
982~No~DISCN~CARLISLE LABORATORIES INC
HYDROXOCOBALAMIN~INJECTABLE;INJECTION~ALPHAREDISOL~MERCK~1MG/ML~A~080778~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
ALPROSTADIL~INJECTABLE;INJECTION~ALPROSTADIL~EUROHLTH INTL SARL~0.5MG/ML~A~07481
5~001~AP~Jan 20, 1998~No~RX~EUROHEALTH INTERNATIONAL SARL
ALPROSTADIL~INJECTABLE;INJECTION~ALPROSTADIL~TEVA PHARMS USA~0.5MG/ML~A~075196~0
01~AP~Apr 30, 1999~No~RX~TEVA PHARMACEUTICALS USA
TECHNETIUM TC-99M MEDRONATE KIT~INJECTABLE;INJECTION~AMERSCAN MDP KIT~GE HEALTHC
ARE~N/A~N~018335~001~~Aug 5, 1982~No~DISCN~GE HEALTHCARE
AMINOCAPROIC ACID~INJECTABLE;INJECTION~AMICAR~CLOVER PHARMS~250MG/ML **Federal R
egister determination that product was not discontinued or withdrawn for safety
or efficacy reasons**~N~015229~002~~Approved Prior to Jan 1, 1982~No~DISCN~CLOVE
R PHARMACEUTICALS CORP
ETOMIDATE~INJECTABLE;INJECTION~AMIDATE~HOSPIRA~2MG/ML~N~018227~001~AP~Sep 7, 198
2~Yes~RX~HOSPIRA INC
AMIFOSTINE~INJECTABLE;INJECTION~AMIFOSTINE~SUN PHARMA GLOBAL~500MG/VIAL~A~077126
~001~AP~Mar 14, 2008~No~RX~SUN PHARMA GLOBAL INC
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~ABBOTT~EQ 250MG BASE/ML~A
~063265~001~~Nov 30, 1994~No~DISCN~ABBOTT LABORATORIES
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~ABBOTT~EQ 250MG BASE/ML~A
~063266~001~~Oct 31, 1994~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~ASTRAZENECA~EQ 50MG BASE/
ML~A~063167~001~~Dec 14, 1995~No~DISCN~ASTRAZENECA LP
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~ASTRAZENECA~EQ 250MG BASE
/ML~A~063169~001~~Dec 14, 1995~No~DISCN~ASTRAZENECA LP
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~EMCURE PHARMS LTD~EQ 250M
G BASE/ML~A~204040~001~AP~Dec 12, 2013~No~RX~EMCURE PHARMACEUTICALS LTD
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~EUROHLTH INTL SARL~EQ 50M
G BASE/ML~A~063313~001~AP~Apr 11, 1994~Yes~RX~EUROHEALTH INTERNATIONAL SARL
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~EUROHLTH INTL SARL~EQ 250
MG BASE/ML~A~063315~001~AP~Apr 11, 1994~Yes~RX~EUROHEALTH INTERNATIONAL SARL
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~HIKMA MAPLE ~EQ 50MG BASE
/ML~A~063274~001~~May 18, 1992~No~DISCN~HIKMA MAPLE LTD
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~HIKMA MAPLE ~EQ 250MG BAS
E/ML~A~063275~001~~May 18, 1992~No~DISCN~HIKMA MAPLE LTD
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~HOSPIRA~EQ 50MG BASE/ML~A
~063263~001~~Nov 30, 1994~No~DISCN~HOSPIRA INC
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~HOSPIRA~EQ 50MG BASE/ML~A
~063350~001~~Jul 30, 1993~No~DISCN~HOSPIRA INC
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~HOSPIRA~EQ 62.5MG BASE/ML
~A~063283~001~~Oct 31, 1994~No~DISCN~HOSPIRA INC
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~HOSPIRA~EQ 250MG BASE/ML~
A~063264~001~~Nov 30, 1994~No~DISCN~HOSPIRA INC
A~063350~002~~Jul 30, 1993~No~DISCN~HOSPIRA INC
A~064098~001~~Jun 26, 1995~No~DISCN~HOSPIRA INC
A~064099~001~~Jun 20, 1995~No~DISCN~HOSPIRA INC
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~TEVA PHARMS USA~EQ 50MG B
ASE/ML~A~064045~001~~Sep 28, 1993~No~DISCN~TEVA PHARMACEUTICALS USA
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE~TEVA PHARMS USA~EQ 250MG
BASE/ML~A~064045~002~AP~Sep 28, 1993~No~RX~TEVA PHARMACEUTICALS USA
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% I
N PLASTIC CONTAINER~HOSPIRA~EQ 500MG BASE/100ML~A~064146~001~~Apr 2, 1997~No~DIS
CN~HOSPIRA WORLDWIDE, INC
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKIN~APOTHECON~EQ 50MG BASE/ML~A~062311~
BB
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKIN~APOTHECON~EQ 50MG BASE/ML~A~062562~
001~~Sep 20, 1984~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKIN~APOTHECON~EQ 50MG BASE/ML~N~050495~
BB
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKIN~APOTHECON~EQ 250MG BASE/ML~A~062311
~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQU
IBB
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKIN~APOTHECON~EQ 250MG BASE/ML~A~062562
~002~~Sep 20, 1984~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKIN~APOTHECON~EQ 250MG BASE/ML~N~050495
~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQU
IBB
AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC
CONTAINER~APOTHECON~EQ 5MG BASE/ML~N~050618~002~~Nov 30, 1987~No~DISCN~APOTHECON
INC DIV BRISTOL MYERS SQUIBB

AMIKACIN SULFATE~INJECTABLE;INJECTION~AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC
CONTAINER~APOTHECON~EQ 10MG BASE/ML~N~050618~001~~Nov 30, 1987~No~DISCN~APOTHECO
N INC DIV BRISTOL MYERS SQUIBB
AMINO ACIDS~INJECTABLE;INJECTION~AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
~HOSPIRA~5.2% (5.2GM/100ML)~N~018901~001~~Apr 6, 1984~No~DISCN~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINO ACIDS~B BRAUN~15%(150GM/1000ML)~A~091112~
001~~Apr 13, 2012~No~RX~B BRAUN MEDICAL INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINO ACIDS~B BRAUN~15%(300GM/2000ML)~A~091112~
002~~Apr 13, 2012~No~RX~B BRAUN MEDICAL INC
AMINOCAPROIC ACID~INJECTABLE;INJECTION~AMINOCAPROIC ACID~ABRAXIS PHARM~250MG/ML~
A~070522~001~~Jun 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
AMINOCAPROIC ACID~INJECTABLE;INJECTION~AMINOCAPROIC ACID~BAXTER HLTHCARE~250MG/M
L~N~018590~001~~Oct 29, 1982~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA AND CRIT
ICAL CARE
AMINOCAPROIC ACID~INJECTABLE;INJECTION~AMINOCAPROIC ACID~HOSPIRA~250MG/ML~A~0708
88~001~~Jun 16, 1988~No~DISCN~HOSPIRA INC
AMINOCAPROIC ACID~INJECTABLE;INJECTION~AMINOCAPROIC ACID~LUITPOLD~250MG/ML~A~071
192~001~AP~Dec 1, 1987~No~RX~LUITPOLD PHARMACEUTICALS INC
AMINOCAPROIC ACID~INJECTABLE;INJECTION~AMINOCAPROIC ACID IN PLASTIC CONTAINER~HO
SPIRA~250MG/ML~A~070010~001~AP~Mar 9, 1987~Yes~RX~HOSPIRA INC
AMINOHIPPURATE SODIUM~INJECTABLE;INJECTION~AMINOHIPPURATE SODIUM~MERCK~20%~N~005
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLIN~GD SEARLE LLC~25MG/ML~A~087243~0
01~~May 24, 1982~No~DISCN~GD SEARLE LLC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLIN~GD SEARLE LLC~25MG/ML~A~087621~0
01~~May 24, 1982~No~DISCN~GD SEARLE LLC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~ABRAXIS PHARM~25MG/ML~A~084568~
001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
001~~Jan 6, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
001~~Aug 30, 1983~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~ELKINS SINN~25MG/ML~A~087239~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~HOSPIRA~25MG/ML~A~087242~001~AP
~Oct 26, 1983~Yes~RX~HOSPIRA INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~HOSPIRA~25MG/ML~A~087601~001~~J
ul 23, 1982~No~DISCN~HOSPIRA INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~INTL MEDICATION~25MG/ML~A~08720
9~001~~Feb 1, 1982~No~DISCN~INTERNATIONAL MEDICATION SYSTEM
7~001~~Nov 10, 1983~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
8~001~~Nov 10, 1983~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~KING PHARMS~25MG/ML~A~086606~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~KING PHARMACEUTICALS INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~LUITPOLD~25MG/ML~A~087240~001~~
Approved Prior to Jan 1, 1982~No~DISCN~LUITPOLD PHARMACEUTICALS INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~LUITPOLD~25MG/ML~A~087600~001~A
P~Approved Prior to Jan 1, 1982~No~RX~LUITPOLD PHARMACEUTICALS INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~LYPHOMED~25MG/ML~A~087431~001~~
Approved Prior to Jan 1, 1982~No~DISCN~LYPHOMED DIV FUJISAWA USA INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~PHARMA SERVE NY~25MG/ML~A~08738
7~001~~Jun 3, 1983~No~DISCN~PHARMA SERVE INC SUB TORIGIAN LABORATORIES
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~PHARMA SERVE NY~25MG/ML~A~08739
2~001~~Dec 15, 1983~No~DISCN~PHARMA SERVE INC SUB TORIGIAN LABORATORIES

AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~SMITH AND NEPHEW~25MG/ML~A~0884
29~001~~May 30, 1985~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~SMITH AND NEPHEW~25MG/ML~A~0887
49~001~~May 30, 1985~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE~TEVA PARENTERAL~25MG/ML~A~08114
2~001~~Sep 25, 1991~No~DISCN~TEVA PARENTERAL MEDICINES INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%~HOSPIR
A~100MG/100ML~A~088147~002~~May 3, 1983~No~DISCN~HOSPIRA INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%~HOSPIR
A~200MG/100ML~A~088147~003~~May 3, 1983~No~DISCN~HOSPIRA INC
AMINOPHYLLINE~INJECTABLE;INJECTION~AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLA
STIC CONTAINER~HOSPIRA~100MG/100ML~N~018924~001~~Dec 12, 1984~No~DISCN~HOSPIRA I
NC
NC
NC
NC
PROTEIN HYDROLYSATE~INJECTABLE;INJECTION~AMINOSOL 5%~ABBVIE~5%~N~005932~012~~Jan
31, 1985~No~DISCN~ABBVIE INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 10%~HOSPIRA~10% (10GM/100ML)~N~017673~
003~~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 10% (PH6)~HOSPIRA~10% (10GM/100ML)~N~0
17673~008~~Nov 18, 1985~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 3.5%~HOSPIRA~3.5% (3.5GM/100ML)~N~0177
89~004~~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 3.5% IN PLASTIC CONTAINER~ABBOTT~3.5%
(3.5GM/100ML)~N~018804~001~~May 15, 1984~No~DISCN~ABBOTT LABORATORIES PHARMACEUT
ICAL PRODUCTS DIV
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 3.5% IN PLASTIC CONTAINER~ABBOTT~3.5%
(3.5GM/100ML)~N~018875~001~~Aug 8, 1984~No~DISCN~ABBOTT LABORATORIES PHARMACEUTI
CAL PRODUCTS DIV
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLOR
IDE~INJECTABLE;INJECTION~AMINOSYN 3.5% M~HOSPIRA~3.5%;21MG/100ML;40MG/100ML;128M
G/100ML;234MG/100ML~N~017789~003~~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA IN
C
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE~INJECTABLE;IN
JECTION~AMINOSYN 3.5% M~HOSPIRA~3.5%;21MG/100ML;128MG/100ML;234MG/100ML~N~017789
~005~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
IDE~INJECTABLE;INJECTION~AMINOSYN 3.5% M IN PLASTIC CONTAINER~ABBOTT~3.5%;21MG/1
00ML;40MG/100ML;128MG/100ML;234MG/100ML~N~018804~002~~May 15, 1984~No~DISCN~ABBO
TT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
IDE~INJECTABLE;INJECTION~AMINOSYN 3.5% M IN PLASTIC CONTAINER~ABBOTT~3.5%;21MG/1
00ML;40MG/100ML;128MG/100ML;234MG/100ML~N~018875~002~~Aug 8, 1984~No~DISCN~ABBOT
T LABORATORIES PHARMACEUTICAL PRODUCTS DIV
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~AMINOSYN 3.5% W/ DEXTROSE 25% IN PLAS
TIC CONTAINER~ABBOTT~3.5%;25GM/100ML~N~019118~001~~Oct 11, 1984~No~DISCN~ABBOTT
LABORATORIES PHARMACEUTICAL PRODUCTS DIV
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~AMINOSYN 3.5% W/ DEXTROSE 5% IN PLAST
IC CONTAINER~ABBOTT~3.5%;5GM/100ML~N~019120~001~~Oct 11, 1984~No~DISCN~ABBOTT LA
BORATORIES PHARMACEUTICAL PRODUCTS DIV
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~AMINOSYN 4.25% W/ DEXTROSE 25% IN PLA
STIC CONTAINER~ABBOTT~4.25%;25GM/100ML~N~019119~001~~Oct 11, 1984~No~DISCN~ABBOT

AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 5%~HOSPIRA~5% (5GM/100ML)~N~017673~001
~~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 7%~HOSPIRA~7% (7GM/100ML)~N~017673~002
~~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 7% (PH6)~HOSPIRA~7% (7GM/100ML)~N~0176
73~006~~Nov 18, 1985~No~RX~HOSPIRA INC
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE~I
NJECTABLE;INJECTION~AMINOSYN 7% W/ ELECTROLYTES~HOSPIRA~7%;102MG/100ML;522MG/100
ML;410MG/100ML~N~017789~002~~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 8.5%~HOSPIRA~8.5% (8.5GM/100ML)~N~0176
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN 8.5% (PH6)~HOSPIRA~8.5% (8.5GM/100ML)~
N~017673~007~~Nov 18, 1985~No~RX~HOSPIRA INC
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE~I
NJECTABLE;INJECTION~AMINOSYN 8.5% W/ ELECTROLYTES~HOSPIRA~8.5%;102MG/100ML;522MG
/100ML;410MG/100ML~N~017673~005~~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN II 10%~HOSPIRA~10% (10GM/100ML)~N~0194
38~005~~Apr 3, 1986~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN II 10% IN PLASTIC CONTAINER~HOSPIRA~10
% (10GM/100ML)~N~020015~001~~Dec 19, 1991~No~RX~HOSPIRA INC
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASI
C; SODIUM CHLORIDE~INJECTABLE;INJECTION~AMINOSYN II 10% W/ ELECTROLYTES~HOSPIRA~
10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML~N~019437~004~~Apr 3, 1986~No~
RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN II 15% IN PLASTIC CONTAINER~HOSPIRA~15
% (15GM/100ML)~N~020041~001~~Dec 19, 1991~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN II 3.5%~HOSPIRA~3.5% (3.5GM/100ML)~N~0
19438~001~~Apr 3, 1986~No~DISCN~HOSPIRA INC
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~AMINOSYN II 3.5% IN DEXTROSE 25% IN P
LASTIC CONTAINER~ABBOTT~3.5%;25GM/100ML~N~019505~002~~Nov 7, 1986~No~DISCN~ABBOT
LASTIC CONTAINER~ABBOTT~3.5%;25GM/100ML~N~019713~006~~Sep 9, 1988~No~DISCN~ABBOT
T LABORATORIES HOSP PRODUCTS DIV
LASTIC CONTAINER~HOSPIRA~3.5%;25GM/100ML~N~019681~001~~Nov 1, 1988~No~DISCN~HOSP
IRA WORLDWIDE, INC
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~AMINOSYN II 3.5% IN DEXTROSE 5% IN PL
ASTIC CONTAINER~ABBOTT~3.5%;5GM/100ML~N~019506~001~~Nov 7, 1986~No~DISCN~ABBOTT
LABORATORIES PHARMACEUTICAL PRODUCTS DIV
ASTIC CONTAINER~ABBOTT~3.5%;5GM/100ML~N~019713~002~~Sep 9, 1988~No~DISCN~ABBOTT
LABORATORIES HOSP PRODUCTS DIV
ASTIC CONTAINER~HOSPIRA~3.5%;5GM/100ML~N~019681~002~~Nov 1, 1988~No~DISCN~HOSPIR
A WORLDWIDE, INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN II 3.5% IN PLASTIC CONTAINER~ABBOTT~3.
5% (3.5GM/100ML)~N~019491~001~~Oct 10, 1986~No~DISCN~ABBOTT LABORATORIES PHARMAC
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHO
SPHATE, DIBASIC, HEPTAHYDRATE~INJECTABLE;INJECTION~AMINOSYN II 3.5% M~HOSPIRA~3.
5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML~N~019437~007~~Apr 3, 1986~No~DIS
CN~HOSPIRA INC
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;
120MG/100ML;49.3MG/100ML~N~019564~001~~Dec 16, 1986~No~DISCN~ABBOTT LABORATORIES
PHARMACEUTICAL PRODUCTS DIV

IN DEXTROSE 5% IN PLASTIC CONTAINER~ABBOTT~3.5%;5GM/100ML;30MG/100ML;97MG/100ML;
120MG/100ML;49.3MG/100ML~N~019712~001~~Sep 8, 1988~No~DISCN~ABBOTT LABORATORIES
HOSP PRODUCTS DIV
IN DEXTROSE 5% IN PLASTIC CONTAINER~HOSPIRA INC~3.5%;5GM/100ML;30MG/100ML;97MG/1
00ML;120MG/100ML;49.3MG/100ML~N~019682~001~~Nov 1, 1988~No~DISCN~HOSPIRA INC
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSP
HATE, DIBASIC, HEPTAHYDRATE~INJECTABLE;INJECTION~AMINOSYN II 3.5% M IN PLASTIC C
ONTAINER~ABBOTT~3.5%;32MG/100ML;128MG/100ML;222MG/100ML;49MG/100ML~N~019493~001~
~Oct 16, 1986~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHA
TE, DIBASIC; SODIUM CHLORIDE~INJECTABLE;INJECTION~AMINOSYN II 3.5% W/ ELECTROLYT
ES IN DEXTROSE 25% IN PLASTIC CONTAINER~ABBOTT~3.5%;25GM/100ML;51MG/100ML;22.4MG
/100ML;261MG/100ML;205MG/100ML~N~019564~002~~Dec 16, 1986~No~DISCN~ABBOTT LABORA
TORIES PHARMACEUTICAL PRODUCTS DIV
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;22.4MG/100ML;261MG/100ML;205MG/100ML~N~01971
4~001~~Sep 12, 1988~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER~HOSPIRA INC
~3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML~N~
019683~001~~Nov 7, 1988~No~DISCN~HOSPIRA INC
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~AMINOSYN II 4.25% IN DEXTROSE 10% IN
PLASTIC CONTAINER~ABBOTT~4.25%;10GM/100ML~N~019713~001~~Sep 9, 1988~No~DISCN~ABB
OTT LABORATORIES HOSP PRODUCTS DIV
PLASTIC CONTAINER~HOSPIRA~4.25%;10GM/100ML~N~019681~004~~Nov 1, 1988~No~DISCN~HO
SPIRA WORLDWIDE, INC
PLASTIC CONTAINER~ABBOTT~4.25%;25GM/100ML~N~019504~002~~Nov 7, 1986~No~DISCN~ABB
OTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
IN DEXTROSE 10% IN PLASTIC CONTAINER~ABBOTT~4.25%;10GM/100ML;30MG/100ML;97MG/10
0ML;120MG/100ML;49.3MG/100ML~N~019564~003~~Dec 16, 1986~No~DISCN~ABBOTT LABORATO
RIES PHARMACEUTICAL PRODUCTS DIV
IN DEXTROSE 10% IN PLASTIC CONTAINER~HOSPIRA INC~4.25%;5GM/100ML;30MG/100ML;97M
G/100ML;120MG/100ML;49.3MG/100ML~N~019682~002~~Nov 1, 1988~No~DISCN~HOSPIRA INC
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~ABBO
TT~4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/10
0ML~N~019712~002~~Sep 8, 1988~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
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~HOSP
IRA INC~4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205
MG/100ML~N~019682~003~~Nov 1, 1988~No~DISCN~HOSPIRA INC
4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER~ABBOTT~4.2
5%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML~N~019
4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER~HOSPIRA IN
C~4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML~
N~019683~002~~Nov 7, 1988~No~DISCN~HOSPIRA INC
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHA
TE, DIBASIC; SODIUM CHLORIDE~INJECTABLE;INJECTION~AMINOSYN II 4.25% W/ ELECTROLY
TES IN DEXTROSE 25% IN PLASTIC CONTAINER~ABBOTT~4.25%;25GM/100ML;51MG/100ML;22.4
MG/100ML;261MG/100ML;205MG/100ML~N~019564~004~~Dec 16, 1986~No~DISCN~ABBOTT LABO
RATORIES PHARMACEUTICAL PRODUCTS DIV
4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER~ABBOTT~4.2
5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML~N~019
4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER~HOSPIRA IN
C~4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML~
N~019683~003~~Nov 7, 1988~No~DISCN~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN II 5%~HOSPIRA~5% (5GM/100ML)~N~019438~
002~~Apr 3, 1986~No~DISCN~HOSPIRA INC
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~AMINOSYN II 5% IN DEXTROSE 25% IN PLA
STIC CONTAINER~ABBOTT~5%;25GM/100ML~N~019565~001~~Dec 17, 1986~No~DISCN~ABBOTT L
ABORATORIES PHARMACEUTICAL PRODUCTS DIV
STIC CONTAINER~ABBOTT~5%;25GM/100ML~N~019713~003~~Sep 9, 1988~No~DISCN~ABBOTT LA
BORATORIES HOSP PRODUCTS DIV
STIC CONTAINER~HOSPIRA~5%;25GM/100ML~N~019681~006~~Nov 1, 1988~No~DISCN~HOSPIRA
WORLDWIDE, INC
5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER~ABBOTT~5%;36.
8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML~N~019714~00
3~~Sep 12, 1988~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER~HOSPIRA INC~5
%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML~N~0196
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN II 7%~HOSPIRA~7% (7GM/100ML)~N~019438~
003~~Apr 3, 1986~No~RX~HOSPIRA INC
C; SODIUM CHLORIDE~INJECTABLE;INJECTION~AMINOSYN II 7% W/ ELECTROLYTES~HOSPIRA~7
%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML~N~019437~006~~Apr 3, 1986~No~DI
SCN~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN II 8.5%~HOSPIRA~8.5% (8.5GM/100ML)~N~0
19438~004~~Apr 3, 1986~No~RX~HOSPIRA INC

C; SODIUM CHLORIDE~INJECTABLE;INJECTION~AMINOSYN II 8.5% W/ ELECTROLYTES~HOSPIRA
~8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML~N~019437~005~~Apr 3, 1986~N
o~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN-HBC 7%~HOSPIRA~7% (7GM/100ML)~N~019374
~001~~Jul 12, 1985~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN-HBC 7% IN PLASTIC CONTAINER~ABBOTT~7%
(7GM/100ML)~N~019400~001~~Jul 23, 1986~No~DISCN~ABBOTT LABORATORIES PHARMACEUTIC
AL PRODUCTS DIV
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN-HF 8%~HOSPIRA~8% (8GM/100ML)~A~020345~
001~~Apr 4, 1996~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN-PF 10%~HOSPIRA~10% (10GM/100ML)~N~0194
92~002~~Oct 17, 1986~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN-PF 7%~HOSPIRA~7% (7GM/100ML)~N~019398~
001~~Sep 6, 1985~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~AMINOSYN-RF 5.2%~HOSPIRA~5.2% (5.2GM/100ML)~N~0
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~AKORN~50M
G/ML~A~076232~001~AP~Jul 5, 2006~Yes~RX~AKORN INC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~BEDFORD~5
0MG/ML~A~076018~001~~Oct 15, 2002~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LA
BORATORIES INC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~BEDFORD L
ABS~50MG/ML~A~076299~001~~Oct 24, 2002~No~DISCN~BEDFORD LABORATORIES
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~BEN VENUE
~50MG/ML~A~076088~001~~Oct 15, 2002~No~DISCN~BEN VENUE LABORATORIES INC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~FRESENIUS
KABI USA~50MG/ML~A~075761~001~AP~Oct 15, 2002~Yes~RX~FRESENIUS KABI USA LLC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~GLAND PHA
RMA LTD~50MG/ML~A~077161~001~AP~Apr 20, 2005~Yes~RX~GLAND PHARMA LTD
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~HIKMA FAR
MACEUTICA~50MG/ML~A~077234~001~AP~Feb 25, 2008~No~RX~HIKMA FARMACEUTICA (PORTUGA
L) SA
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~HOSPIRA~5
0MG/ML~A~075955~001~AP~Oct 18, 2002~Yes~RX~HOSPIRA INC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~HOSPIRA~5
0MG/ML~A~076108~001~~Oct 15, 2002~No~DISCN~HOSPIRA INC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~HOSPIRA I
NC~50MG/ML~A~203884~001~AP~Nov 25, 2013~No~RX~HOSPIRA INC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~HOSPIRA I
NC~50MG/ML~A~203885~001~AP~Nov 25, 2013~No~RX~HOSPIRA INC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~INTL MEDI
CATION SYS~50MG/ML~N~021594~001~~Feb 4, 2004~No~DISCN~INTERNATIONAL MEDICATION S
YSTEMS LTD
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~MYLAN INS
TITUTIONAL~50MG/ML~A~076217~001~AP~Oct 15, 2002~Yes~RX~MYLAN INSTITUTIONAL LLC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~PAR STERI
LE PRODUCTS~50MG/ML~A~076394~001~~Apr 25, 2003~No~DISCN~PAR STERILE PRODUCTS LLC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~TEVA PHAR
MS USA~50MG/ML~A~076163~001~~Sep 5, 2003~No~DISCN~TEVA PHARMACEUTICALS USA
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~WOCKHARDT
~50MG/ML~A~077610~001~AP~Oct 30, 2008~No~RX~WOCKHARDT LTD
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~AMIODARONE HYDROCHLORIDE~WOCKHARDT
~50MG/ML~A~077834~001~AP~Oct 30, 2008~No~RX~WOCKHARDT LTD
METRIZAMIDE~INJECTABLE;INJECTION~AMIPAQUE~GE HEALTHCARE~2.5GM/VIAL~N~017982~003~
~Sep 12, 1983~No~DISCN~GE HEALTHCARE
METRIZAMIDE~INJECTABLE;INJECTION~AMIPAQUE~GE HEALTHCARE~3.75GM/VIAL~N~017982~001
~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE

~~Sep 12, 1983~No~DISCN~GE HEALTHCARE
AMITRIPTYLINE HYDROCHLORIDE~INJECTABLE;INJECTION~AMITRIPTYLINE HYDROCHLORIDE~WAT
SON LABS~10MG/ML~A~085594~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LAB
ORATORIES INC
AMMONIUM CHLORIDE~INJECTABLE;INJECTION~AMMONIUM CHLORIDE~ABBOTT~5MEQ/ML~A~083130
~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL
PRODUCTS DIV
AMMONIUM CHLORIDE~INJECTABLE;INJECTION~AMMONIUM CHLORIDE~GD SEARLE LLC~3MEQ/ML~A
~086205~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
AMMONIUM CHLORIDE~INJECTABLE;INJECTION~AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE~M
CGAW~900MG/100ML~N~006580~001~~Approved Prior to Jan 1, 1982~No~DISCN~MCGAW INC
AMMONIUM CHLORIDE~INJECTABLE;INJECTION~AMMONIUM CHLORIDE 2.14%~B BRAUN~40MEQ/100
ML~A~085734~001~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
AMMONIUM CHLORIDE~INJECTABLE;INJECTION~AMMONIUM CHLORIDE IN PLASTIC CONTAINER~HO
SPIRA~5MEQ/ML~A~088366~001~~Jun 13, 1984~Yes~RX~HOSPIRA INC
HYALURONIDASE~INJECTABLE;INJECTION~AMPHADASE~AMPHASTAR PHARM~150 UNITS/ML~N~0216
65~001~~Oct 26, 2004~Yes~RX~AMPHASTAR PHARMACEUTICAL INC
AMPHOTERICIN B~INJECTABLE;INJECTION~AMPHOTERICIN B~ABBOTT~50MG/VIAL~A~064141~001
~~Dec 23, 1996~No~DISCN~ABBOTT LABORATORIES
AMPHOTERICIN B~INJECTABLE;INJECTION~AMPHOTERICIN B~ABRAXIS PHARM~50MG/VIAL~A~062
728~001~~Apr 13, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
AMPHOTERICIN B~INJECTABLE;INJECTION~AMPHOTERICIN B~TEVA PARENTERAL~50MG/VIAL~A~0
64062~001~~Mar 31, 1995~No~DISCN~TEVA PARENTERAL MEDICINES INC
AMPHOTERICIN B~INJECTABLE;INJECTION~AMPHOTERICIN B~X GEN PHARMS~50MG/VIAL~A~0632
06~001~~Apr 29, 1992~Yes~RX~X GEN PHARMACEUTICALS INC
AMPICILLIN SODIUM; SULBACTAM SODIUM~INJECTABLE;INJECTION~AMPICILLIN AND SULBACTA
M~ACS DOBFAR~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~065406~001~AP~Dec 22, 2009~No
~RX~ACS DOBFAR SPA
M~ACS DOBFAR~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~065406~002~AP~Dec 22, 2009~No~R
X~ACS DOBFAR SPA
M~ACS DOBFAR~EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL~A~065403~001~AP~Dec 23, 2009~No~
RX~ACS DOBFAR SPA
M~AGILA SPECLTS~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~201024~001~AP~Apr 7, 2014~
No~RX~AGILA SPECIALTIES PRIVATE LTD
M~AGILA SPECLTS~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~201024~002~AP~Apr 7, 2014~No
~RX~AGILA SPECIALTIES PRIVATE LTD
M~AGILA SPECLTS~EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL~A~202197~001~AP~Apr 7, 2014~N
o~RX~AGILA SPECIALTIES PRIVATE LTD
M~AUROBINDO PHARMA~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~090340~001~AP~Sep 20, 2
010~No~RX~AUROBINDO PHARMA
M~AUROBINDO PHARMA~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~090349~001~AP~Sep 20, 2
M~AUROBINDO PHARMA~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~090340~002~AP~Sep 20, 201

M~HANFORD GC~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~065176~001~AP~Nov 30, 2005~No
~RX~GC HANFORD MANUFACTURING CO
M~HANFORD GC~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~065176~002~AP~Nov 30, 2005~No~R
X~GC HANFORD MANUFACTURING CO
M~HANFORD GC~EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL~A~065188~001~AP~Nov 25, 2005~No~
RX~GC HANFORD MANUFACTURING CO
M~HIKMA MAPLE ~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~065074~001~AP~Mar 19, 2002~
No~RX~HIKMA MAPLE LTD
M~HIKMA MAPLE ~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~065074~002~AP~Mar 19, 2002~No
~RX~HIKMA MAPLE LTD
M~HIKMA MAPLE ~EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL~A~065076~001~AP~Mar 19, 2002~N
o~RX~HIKMA MAPLE LTD
M~HOSPIRA INC~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~090375~001~AP~Dec 21, 2011~N
o~RX~HOSPIRA INC
M~HOSPIRA INC~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~090653~001~AP~Dec 21, 2011~N
o~RX~HOSPIRA INC
M~HOSPIRA INC~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~090375~002~AP~Dec 21, 2011~No~
RX~HOSPIRA INC
M~HOSPIRA INC~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~090653~002~AP~Dec 21, 2011~No~
RX~HOSPIRA INC
M~HOSPIRA INC~EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL~A~090646~001~AP~Dec 21, 2011~No
~RX~HOSPIRA INC
M~ISTITUTO BIO ITA SPA~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~065222~001~AP~Nov 2
9, 2005~No~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
M~ISTITUTO BIO ITA SPA~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~065222~002~AP~Nov 29,
2005~No~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
M~ISTITUTO BIO ITA SPA~EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL~A~065314~001~AP~Nov 27
, 2006~No~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
M~MUSTAFA NEVZAT ILAC~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~065316~001~AP~Jun 29
, 2007~No~RX~MUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)
M~MUSTAFA NEVZAT ILAC~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~065316~002~AP~Jun 29,
2007~No~RX~MUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)
M~SANDOZ~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~065241~001~AP~Jul 25, 2006~No~RX~
SANDOZ INC
M~SANDOZ~EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL~A~065310~001~AP~Jul 25, 2006~No~RX~
SANDOZ INC
M~SANDOZ~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~065241~002~AP~Jul 25, 2006~No~RX~SA
NDOZ INC
M~SANDOZ~EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL~A~065310~002~AP~Jul 25, 2006~No~RX~SA
NDOZ INC

M~SANDOZ~EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL~A~065240~001~AP~Jul 25, 2006~No~RX~S
ANDOZ INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ACS DOBFAR SPA~EQ 1GM B
ASE/VIAL~A~090884~002~AP~Apr 3, 2013~No~RX~ACS DOBFAR SPA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ACS DOBFAR SPA~EQ 2GM B
ASE/VIAL~A~090884~003~AP~Apr 3, 2013~No~RX~ACS DOBFAR SPA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ACS DOBFAR SPA~EQ 10GM
BASE/VIAL~A~090889~001~AP~Apr 3, 2013~No~RX~ACS DOBFAR SPA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ACS DOBFAR SPA~EQ 500MG
BASE/VIAL~A~090884~001~AP~Apr 3, 2013~No~RX~ACS DOBFAR SPA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~AGILA SPECLTS~EQ 10GM B
ASE/VIAL~A~202198~001~AP~Apr 7, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ANTIBIOTICE~EQ 1GM BASE
/VIAL~A~090354~003~AP~Dec 28, 2009~No~RX~ANTIBIOTICE SA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ANTIBIOTICE~EQ 2GM BASE
/VIAL~A~090354~004~AP~Dec 28, 2009~No~RX~ANTIBIOTICE SA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ANTIBIOTICE~EQ 250MG BA
SE/VIAL~A~090354~001~AP~Dec 28, 2009~No~RX~ANTIBIOTICE SA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ANTIBIOTICE~EQ 500MG BA
SE/VIAL~A~090354~002~AP~Dec 28, 2009~No~RX~ANTIBIOTICE SA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~APOTHECON~EQ 1GM BASE/V
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~APOTHECON~EQ 2GM BASE/V
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~APOTHECON~EQ 125MG BASE
/VIAL~A~062860~001~~Feb 5, 1988~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~AUROBINDO PHARMA~EQ 1GM
BASE/VIAL~A~065499~004~AP~Aug 17, 2010~No~RX~AUROBINDO PHARMA LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~AUROBINDO PHARMA~EQ 2GM
BASE/VIAL~A~065499~005~AP~Aug 17, 2010~No~RX~AUROBINDO PHARMA LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~AUROBINDO PHARMA~EQ 10G
M BASE/VIAL~A~065493~001~AP~Aug 17, 2010~No~RX~AUROBINDO PHARMA LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~AUROBINDO PHARMA~EQ 125
MG BASE/VIAL~A~065499~001~AP~Aug 17, 2010~No~RX~AUROBINDO PHARMA LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~CONSOLIDATED PHARM~EQ 1
GM BASE/VIAL~A~061936~003~~Approved Prior to Jan 1, 1982~No~DISCN~CONSOLIDATED P
HARMACEUTICAL GROUP INC
GM BASE/VIAL~A~061936~004~~Approved Prior to Jan 1, 1982~No~DISCN~CONSOLIDATED P
HARMACEUTICAL GROUP INC
25MG BASE/VIAL~A~061936~005~~Approved Prior to Jan 1, 1982~No~DISCN~CONSOLIDATED
PHARMACEUTICAL GROUP INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~HANFORD GC~EQ 1GM BASE/
VIAL~A~062772~001~AP~Apr 15, 1993~No~RX~GC HANFORD MANUFACTURING CO

VIAL~A~063139~001~~Apr 15, 1993~No~DISCN~GC HANFORD MANUFACTURING CO
VIAL~A~063140~001~AP~Apr 15, 1993~No~RX~GC HANFORD MANUFACTURING CO
VIAL~A~063141~001~~Apr 15, 1993~No~DISCN~GC HANFORD MANUFACTURING CO
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~HANFORD GC~EQ 10GM BASE
/VIAL~A~063142~001~AP~Apr 15, 1993~No~RX~GC HANFORD MANUFACTURING CO
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~HANFORD GC~EQ 125MG BAS
E/VIAL~A~063143~001~~Apr 15, 1993~No~DISCN~GC HANFORD MANUFACTURING CO
E/VIAL~A~063145~001~AP~Apr 15, 1993~No~RX~GC HANFORD MANUFACTURING CO
E/VIAL~A~063146~001~AP~Apr 15, 1993~No~RX~GC HANFORD MANUFACTURING CO
E/VIAL~A~063147~001~~Apr 15, 1993~No~DISCN~GC HANFORD MANUFACTURING CO
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~HIKMA MAPLE ~EQ 1GM BAS
E/VIAL~A~062692~004~~Jun 24, 1986~No~DISCN~HIKMA MAPLE LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~HIKMA MAPLE ~EQ 2GM BAS
E/VIAL~A~062692~005~~Jun 24, 1986~No~DISCN~HIKMA MAPLE LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~HIKMA MAPLE ~EQ 10GM BA
SE/VIAL~A~062692~006~~Jun 24, 1986~No~DISCN~HIKMA MAPLE LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~HIKMA MAPLE ~EQ 125MG B
ASE/VIAL~A~062692~001~~Jun 24, 1986~No~DISCN~HIKMA MAPLE LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~INTL MEDICATION~EQ 1GM
BASE/VIAL~A~062634~002~~Jan 9, 1987~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LT
D
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~INTL MEDICATION~EQ 2GM
BASE/VIAL~A~062634~003~~Jan 9, 1987~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LT
D
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~ISTITUTO BIO ITA SPA~EQ
1GM BASE/VIAL~A~062719~002~AP~May 12, 1987~No~RX~ISTITUTO BIOCHIMICO ITALIANO S
PA
2GM BASE/VIAL~A~062797~002~AP~Jul 12, 1993~No~RX~ISTITUTO BIOCHIMICO ITALIANO S
PA
10GM BASE/VIAL~A~201404~001~AP~Dec 20, 2013~No~RX~ISTITUTO BIOCHIMICO ITALIANO
SPA
125MG BASE/VIAL~A~062797~001~AP~Jul 12, 1993~No~RX~ISTITUTO BIOCHIMICO ITALIANO
SPA
250MG BASE/VIAL~A~062719~001~AP~May 12, 1987~No~RX~ISTITUTO BIOCHIMICO ITALIANO
SPA
500MG BASE/VIAL~A~062719~003~AP~May 12, 1987~No~RX~ISTITUTO BIOCHIMICO ITALIANO
SPA
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~LILLY~EQ 1GM BASE/VIAL~
A~062565~002~~Apr 4, 1985~No~DISCN~ELI LILLY AND CO
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~LILLY~EQ 2GM BASE/VIAL~
A~062565~003~~Jun 24, 1986~No~DISCN~ELI LILLY AND CO
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~LILLY~EQ 500MG BASE/VIA
L~A~062565~001~~Apr 4, 1985~No~DISCN~ELI LILLY AND CO
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~SANDOZ~EQ 1GM BASE/VIAL
~A~061395~004~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~SANDOZ~EQ 2GM BASE/VIAL

~A~061395~005~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~SANDOZ~EQ 10GM BASE/VIA
L~A~061395~006~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~SANDOZ~EQ 125MG BASE/VI
AL~A~061395~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~STRIDES ARCOLAB LTD~EQ
1GM BASE/VIAL~A~201025~003~AP~Apr 9, 2014~No~RX~STRIDES ARCOLAB LTD
2GM BASE/VIAL~A~201025~004~AP~Apr 9, 2014~No~RX~STRIDES ARCOLAB LTD
250MG BASE/VIAL~A~201025~001~AP~Apr 9, 2014~No~RX~STRIDES ARCOLAB LTD
500MG BASE/VIAL~A~201025~002~AP~Apr 9, 2014~No~RX~STRIDES ARCOLAB LTD
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~WATSON LABS INC~EQ 1GM
BASE/VIAL~A~062816~004~~Oct 24, 1988~No~DISCN~WATSON LABORATORIES INC
BASE/VIAL~A~062994~001~~Sep 15, 1988~No~DISCN~WATSON LABORATORIES INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~AMPICILLIN SODIUM~WATSON LABS INC~EQ 125M
G BASE/VIAL~A~062816~001~~Oct 24, 1988~No~DISCN~WATSON LABORATORIES INC
INAMRINONE LACTATE~INJECTABLE;INJECTION~AMRINONE LACTATE~BAXTER HLTHCARE CORP~EQ
5MG BASE/ML~A~075542~001~~May 10, 2000~No~DISCN~BAXTER HEALTHCARE CORP ANESTHES
IA CRITICAL CARE
INAMRINONE LACTATE~INJECTABLE;INJECTION~AMRINONE LACTATE~EUROHLTH INTL SARL~EQ 5
MG BASE/ML~A~075513~001~~May 9, 2000~Yes~RX~EUROHEALTH INTERNATIONAL SARL
INAMRINONE LACTATE~INJECTABLE;INJECTION~AMRINONE LACTATE~HOSPIRA~EQ 5MG BASE/ML~
A~074616~001~~Aug 3, 1998~No~DISCN~HOSPIRA INC
TECHNETIUM TC-99M PENTETATE KIT~INJECTABLE;INJECTION~AN-DTPA~JUBILANT DRAXIMAGE~
N/A~N~017714~001~AP~Approved Prior to Jan 1, 1982~No~RX~JUBILANT DRAXIMAGE INC
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT~INJECTABLE;INJECTION~AN-MAA~PHARMALUCEN
CE~N/A~N~017792~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMALUCENCE INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF~GLAXOSMITHKLINE~EQ 1GM BASE/VIAL~N~0
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF~GLAXOSMITHKLINE~EQ 5GM BASE/VIAL **F
safety or efficacy reasons**~N~050461~004~~Approved Prior to Jan 1, 1982~No~DIS
CN~GLAXOSMITHKLINE
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF~GLAXOSMITHKLINE~EQ 10GM BASE/VIAL~N~
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF~GLAXOSMITHKLINE~EQ 250MG BASE/VIAL *
*Federal Register determination that product was not discontinued or withdrawn f
or safety or efficacy reasons**~N~050461~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~GLAXOSMITHKLINE
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF~GLAXOSMITHKLINE~EQ 500MG BASE/VIAL~N
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER~
BAXTER HLTHCARE~EQ 10MG BASE/ML~N~050566~003~~Jun 8, 1983~No~DISCN~BAXTER HEALTH
CARE CORP
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER~
BAXTER HLTHCARE~EQ 20MG BASE/ML~N~050566~004~~Jun 8, 1983~No~DISCN~BAXTER HEALTH
CARE CORP
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF IN PLASTIC CONTAINER~BAXTER HLTHCARE
~EQ 10MG BASE/ML~A~063002~001~~Mar 28, 1991~Yes~RX~BAXTER HEALTHCARE CORP
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF IN PLASTIC CONTAINER~BAXTER HLTHCARE
~EQ 20MG BASE/ML~A~063002~002~~Mar 28, 1991~Yes~RX~BAXTER HEALTHCARE CORP
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC C
ONTAINER~BAXTER HLTHCARE~EQ 10MG BASE/ML~N~050566~001~~Jun 8, 1983~No~DISCN~BAXT
ER HEALTHCARE CORP
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC C
ONTAINER~BAXTER HLTHCARE~EQ 20MG BASE/ML~N~050566~002~~Jun 8, 1983~No~DISCN~BAXT
ER HEALTHCARE CORP
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~ANECTINE~SANDOZ~1GM/VIAL~N~008453~
004~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ CANADA INC
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~ANECTINE~SANDOZ~20MG/ML~N~008453~0
02~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ CANADA INC
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~ANECTINE~SANDOZ~50MG/ML~N~008453~0
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~ANECTINE~SANDOZ~500MG/VIAL~N~00845
3~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ CANADA INC
IOTHALAMATE SODIUM~INJECTABLE;INJECTION~ANGIO-CONRAY~MALLINCKRODT~80%~N~013319~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
DIATRIZOATE MEGLUMINE~INJECTABLE;INJECTION~ANGIOVIST 282~BAYER HLTHCARE~60%~A~08
7726~001~~Sep 23, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~ANGIOVIST 292~BAY
ER HLTHCARE~52%;8%~A~087724~001~~Sep 23, 1982~No~DISCN~BAYER HEALTHCARE PHARMACE
UTICALS INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~ANGIOVIST 370~BAY
ER HLTHCARE~66%;10%~A~087723~001~~Sep 23, 1982~No~DISCN~BAYER HEALTHCARE PHARMAC
EUTICALS INC
PENTOLINIUM TARTRATE~INJECTABLE;INJECTION~ANSOLYSEN~WYETH AYERST~10MG/ML~N~00937
FOMEPIZOLE~INJECTABLE;INJECTION~ANTIZOL~PALADIN LABS~1.5GM/1.5ML (1GM/ML)~N~0206
96~001~AP~Dec 4, 1997~Yes~RX~PALADIN LABS USA INC
DOLASETRON MESYLATE~INJECTABLE;INJECTION~ANZEMET~SANOFI AVENTIS US~12.5MG/0.625M
L (20MG/ML)~N~020624~002~~Sep 11, 1997~Yes~RX~SANOFI AVENTIS US LLC
DOLASETRON MESYLATE~INJECTABLE;INJECTION~ANZEMET~SANOFI AVENTIS US~100MG/5ML (20
MG/ML)~N~020624~001~~Sep 11, 1997~Yes~RX~SANOFI AVENTIS US LLC
DOLASETRON MESYLATE~INJECTABLE;INJECTION~ANZEMET~SANOFI AVENTIS US~500MG/25ML (2
0MG/ML)~N~020624~003~~Dec 11, 2001~Yes~RX~SANOFI AVENTIS US LLC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~APOGEN~KING PHARMS~EQ 10MG BASE/ML~A~062
289~001~~Approved Prior to Jan 1, 1982~No~DISCN~KING PHARMACEUTICALS INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~APOGEN~KING PHARMS~EQ 40MG BASE/ML~A~062
HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~APRESOLINE~NOVARTIS~20MG/ML~N~008
PHYTONADIONE~INJECTABLE;INJECTION~AQUAMEPHYTON~BIOVAIL TECHNOLOGIES~1MG/0.5ML~N~
012223~002~~Approved Prior to Jan 1, 1982~No~DISCN~BIOVAIL TECHNOLOGIES LTD
PHYTONADIONE~INJECTABLE;INJECTION~AQUAMEPHYTON~BIOVAIL TECHNOLOGIES~10MG/ML~N~01
2223~001~~Approved Prior to Jan 1, 1982~No~DISCN~BIOVAIL TECHNOLOGIES LTD
VITAMIN A PALMITATE~INJECTABLE;INJECTION~AQUASOL A~HOSPIRA~EQ 50,000 UNITS BASE/
ML~N~006823~001~~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
CHLOROQUINE HYDROCHLORIDE~INJECTABLE;INJECTION~ARALEN HYDROCHLORIDE~SANOFI AVENT
IS US~EQ 40MG BASE/ML~N~006002~002~~Approved Prior to Jan 1, 1982~No~DISCN~SANOF
I AVENTIS US LLC
METARAMINOL BITARTRATE~INJECTABLE;INJECTION~ARAMINE~MERCK~EQ 10MG BASE/ML~N~0095
09~002~~Dec 22, 1987~No~DISCN~MERCK AND CO INC
PIPECURONIUM BROMIDE~INJECTABLE;INJECTION~ARDUAN~ORGANON USA INC~10MG/VIAL~N~019
638~001~~Jun 26, 1990~No~DISCN~ORGANON USA INC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~AREDIA~NOVARTIS~30MG/VIAL~N~020036~001
~~Oct 31, 1991~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
~~May 6, 1993~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
~~May 6, 1993~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ARESTOCAINE HYDROCHLORIDE~SOLVAY~
3%~A~084777~002~~Apr 18, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ARESTOCAINE HYDROC
HLORIDE W/ LEVONORDEFRIN~SOLVAY~0.05MG/ML;2%~A~085010~001~~Approved Prior to Jan
1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
TRIMETHAPHAN CAMSYLATE~INJECTABLE;INJECTION~ARFONAD~ROCHE~50MG/ML~N~008983~001~~
Approved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
ARGATROBAN~INJECTABLE;INJECTION~ARGATROBAN~HIKMA PHARM CO LTD~250MG/2.5ML (100MG
/ML)~N~203049~001~AP~Jan 5, 2012~No~RX~HIKMA PHARM CO LTD
ARGATROBAN~INJECTABLE;INJECTION~ARGATROBAN~MYLAN INSTITUTIONAL~250MG/2.5ML (100M
G/ML)~A~202626~001~AP~Jun 30, 2014~No~RX~MYLAN INSTITUTIONAL LLC
ARGATROBAN~INJECTABLE;INJECTION~ARGATROBAN~PAR STERILE PRODUCTS~250MG/2.5ML (100
MG/ML)~A~091665~001~AP~Jun 30, 2014~No~RX~PAR STERILE PRODUCTS LLC
TRIAMCINOLONE DIACETATE~INJECTABLE;INJECTION~ARISTOCORT~SANDOZ~25MG/ML~N~011685~
TRIAMCINOLONE DIACETATE~INJECTABLE;INJECTION~ARISTOCORT~SANDOZ~40MG/ML **Federal
y or efficacy reasons**~N~012802~001~~Approved Prior to Jan 1, 1982~No~DISCN~SAN
DOZ CANADA INC
TRIAMCINOLONE HEXACETONIDE~INJECTABLE;INJECTION~ARISTOSPAN~SANDOZ~5MG/ML~N~01646
6~001~~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ CANADA INC
TRIAMCINOLONE HEXACETONIDE~INJECTABLE;INJECTION~ARISTOSPAN~SANDOZ~20MG/ML~N~0164
66~002~~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ CANADA INC
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~ARTICAINE H
YDROCHLORIDE AND EPINEPHRINE BITARTRATE~HOSPIRA~4%;EQ 0.017MG BASE/1.7ML (4%;EQ
0.01MG BASE/ML)~A~079138~001~AP~Jun 18, 2010~No~RX~HOSPIRA INC
SOMATROPIN~INJECTABLE;INJECTION~ASELLACRIN 10~SERONO~10 IU/VIAL~N~017726~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~SERONO LABORATORIES INC
SOMATROPIN~INJECTABLE;INJECTION~ASELLACRIN 2~SERONO~2 IU/VIAL~N~017726~002~~Jul
21, 1983~No~DISCN~SERONO LABORATORIES INC
MORPHINE SULFATE~INJECTABLE;INJECTION~ASTRAMORPH PF~FRESENIUS KABI USA~0.5MG/ML~
A~071050~001~AP~Oct 7, 1986~No~RX~FRESENIUS KABI USA LLC
MORPHINE SULFATE~INJECTABLE;INJECTION~ASTRAMORPH PF~FRESENIUS KABI USA~0.5MG/ML~
A~071051~001~AP~Oct 7, 1986~No~RX~FRESENIUS KABI USA LLC
MORPHINE SULFATE~INJECTABLE;INJECTION~ASTRAMORPH PF~FRESENIUS KABI USA~1MG/ML~A~
071052~001~AP~Oct 7, 1986~No~RX~FRESENIUS KABI USA LLC
MORPHINE SULFATE~INJECTABLE;INJECTION~ASTRAMORPH PF~FRESENIUS KABI USA~1MG/ML~A~
071053~001~AP~Oct 7, 1986~No~RX~FRESENIUS KABI USA LLC
LORAZEPAM~INJECTABLE;INJECTION~ATIVAN~HIKMA MAPLE ~2MG/ML~N~018140~001~AP~Approv
ed Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE LTD
LORAZEPAM~INJECTABLE;INJECTION~ATIVAN~HIKMA MAPLE ~4MG/ML~N~018140~002~AP~Approv
ed Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE LTD
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~BAXTER HLTHCARE~10M
G/ML~A~074824~001~~Sep 30, 1997~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA AND C
RITICAL CARE
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~BAXTER HLTHCARE COR
P~10MG/ML~A~074753~001~~Jan 23, 1997~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA
CRITICAL CARE
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~EUROHLTH INTL SARL~
10MG/ML~A~074901~001~AP~Jul 18, 1997~Yes~RX~EUROHEALTH INTERNATIONAL SARL
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~HOSPIRA~10MG/ML~A~0
74632~001~~Dec 23, 1996~No~DISCN~HOSPIRA INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~HOSPIRA~10MG/ML~A~0
74740~001~~Mar 28, 1997~No~DISCN~HOSPIRA INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~HOSPIRA INC~10MG/ML
~A~090761~001~AP~Oct 18, 2012~No~RX~HOSPIRA INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~SAGENT PHARMS~10MG/

ML~A~091489~001~AP~Feb 17, 2012~No~RX~SAGENT PHARMACEUTICALS INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~TEVA PARENTERAL~10M
G/ML~A~074784~001~~Jun 11, 1997~No~DISCN~TEVA PARENTERAL MEDICINES INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE~WATSON LABS INC~10M
G/ML~A~074945~001~~Jul 28, 1998~No~DISCN~WATSON LABORATORIES INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE PRESERVATIVE FREE~B
AXTER HLTHCARE~10MG/ML~A~074825~001~~Sep 30, 1997~No~DISCN~BAXTER HEALTHCARE COR
P ANESTHESIA AND CRITICAL CARE
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE PRESERVATIVE FREE~B
AXTER HLTHCARE CORP~10MG/ML~A~074768~001~~Jan 23, 1997~No~DISCN~BAXTER HEALTHCAR
E CORP ANESTHESIA CRITICAL CARE
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE PRESERVATIVE FREE~E
UROHLTH INTL SARL~10MG/ML~A~074900~001~AP~Jul 18, 1997~Yes~RX~EUROHEALTH INTERNA
TIONAL SARL
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE PRESERVATIVE FREE~H
OSPIRA~10MG/ML~A~074633~001~~Dec 23, 1996~No~DISCN~HOSPIRA INC
OSPIRA~10MG/ML~A~074639~001~~Mar 25, 1997~No~DISCN~HOSPIRA INC
OSPIRA~10MG/ML~A~074741~001~~Mar 28, 1997~No~DISCN~HOSPIRA INC
OSPIRA INC~10MG/ML~A~090782~001~AP~Oct 18, 2012~No~RX~HOSPIRA INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE PRESERVATIVE FREE~S
AGENT PHARMS~10MG/ML~A~091488~001~AP~Feb 17, 2012~No~RX~SAGENT PHARMACEUTICALS I
NC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~ATRACURIUM BESYLATE PRESERVATIVE FREE~W
ATSON LABS INC~10MG/ML~A~074944~001~~Jul 28, 1998~No~DISCN~WATSON LABORATORIES I
NC
ATROPINE~INJECTABLE;INJECTION~ATROPEN~MERIDIAN MEDCL TECHN~EQ 0.25MG SULFATE/0.3
ML~N~017106~004~~Sep 17, 2004~Yes~RX~MERIDIAN MEDICAL TECHNOLOGIES INC
ATROPINE~INJECTABLE;INJECTION~ATROPEN~MERIDIAN MEDCL TECHN~EQ 0.5MG SULFATE/0.7M
L~N~017106~003~~Jun 19, 2003~Yes~RX~MERIDIAN MEDICAL TECHNOLOGIES INC
ATROPINE~INJECTABLE;INJECTION~ATROPEN~MERIDIAN MEDCL TECHN~EQ 1MG SULFATE/0.7ML~
N~017106~002~~Jun 19, 2003~Yes~RX~MERIDIAN MEDICAL TECHNOLOGIES INC
ATROPINE~INJECTABLE;INJECTION~ATROPEN~MERIDIAN MEDCL TECHN~EQ 2MG SULFATE/0.7ML~
N~017106~001~~Approved Prior to Jan 1, 1982~Yes~RX~MERIDIAN MEDICAL TECHNOLOGIES
INC
ATROPINE~INJECTABLE;INJECTION~ATROPINE~ABBVIE~EQ 2MG SULFATE/0.7ML~A~071295~001~
~Jan 30, 1987~No~DISCN~ABBVIE INC
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~ATROPINE AND DEM
EROL~ABBVIE~0.4MG/ML;50MG/ML~A~087853~001~~Nov 26, 1982~No~DISCN~ABBVIE INC
AZTREONAM~INJECTABLE;INJECTION~AZACTAM~BRISTOL MYERS SQUIBB~1GM/VIAL~N~050580~00
2~AP~Dec 31, 1986~Yes~RX~BRISTOL MYERS SQUIBB
AZTREONAM~INJECTABLE;INJECTION~AZACTAM~BRISTOL MYERS SQUIBB~2GM/VIAL~N~050580~00
3~AP~Dec 31, 1986~Yes~RX~BRISTOL MYERS SQUIBB
AZTREONAM~INJECTABLE;INJECTION~AZACTAM~BRISTOL MYERS SQUIBB~500MG/VIAL~N~050580~
001~~Dec 31, 1986~No~DISCN~BRISTOL MYERS SQUIBB
AZTREONAM~INJECTABLE;INJECTION~AZACTAM IN PLASTIC CONTAINER~BRISTOL MYERS SQUIBB
~10MG/ML~N~050632~003~~May 24, 1989~No~DISCN~BRISTOL MYERS SQUIBB CO
~20MG/ML~N~050632~002~~May 24, 1989~Yes~RX~BRISTOL MYERS SQUIBB CO
~40MG/ML~N~050632~001~~May 24, 1989~Yes~RX~BRISTOL MYERS SQUIBB CO
AZATHIOPRINE SODIUM~INJECTABLE;INJECTION~AZATHIOPRINE SODIUM~EUROHLTH INTL SARL~
EQ 100MG BASE/VIAL~A~074419~001~~Mar 31, 1995~Yes~RX~EUROHEALTH INTERNATIONAL SA
RL
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~FRESENIUS KABI USA~EQ 500MG BASE/
VIAL~A~065179~001~AP~Dec 13, 2005~No~RX~FRESENIUS KABI USA LLC
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~GLAND PHARMA LTD~EQ 500MG BASE/VI
AL~A~065501~001~AP~Nov 9, 2009~No~RX~GLAND PHARMA LTD
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~HOSPIRA~EQ 500MG BASE/VIAL~A~0655
00~001~AP~Jun 26, 2009~No~RX~HOSPIRA INC
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~HOSPIRA~EQ 500MG BASE/VIAL~A~0655
11~001~AP~Jun 26, 2009~No~RX~HOSPIRA INC
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~PLIVA HRVATSKA DOO~EQ 500MG BASE/
VIAL~A~065265~001~~Jan 18, 2007~No~DISCN~PLIVA HRVATSKA DOO
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~SAGENT STRIDES~EQ 500MG BASE/VIAL
~A~065506~001~AP~Mar 24, 2009~No~RX~SAGENT STRIDES LLC
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~SUN PHARM INDS LTD~EQ 500MG BASE/
VIAL~A~090923~001~AP~Apr 2, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~TEVA PARENTERAL~EQ 2.5GM BASE/VIA
L~N~050809~002~~Dec 19, 2006~No~DISCN~TEVA PARENTERAL MEDICINES INC
AZITHROMYCIN~INJECTABLE;INJECTION~AZITHROMYCIN~TEVA PARENTERAL~EQ 500MG BASE/VIA
L~N~050809~001~~Dec 19, 2006~No~DISCN~TEVA PARENTERAL MEDICINES INC
AZLOCILLIN SODIUM~INJECTABLE;INJECTION~AZLIN~BAYER PHARMS~EQ 2GM BASE/VIAL~A~062
388~001~~Sep 8, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
417~001~~Oct 12, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
AZLOCILLIN SODIUM~INJECTABLE;INJECTION~AZLIN~BAYER PHARMS~EQ 2GM BASE/VIAL~N~050
AZTREONAM~INJECTABLE;INJECTION~AZTREONAM~EUROHLTH INTL SARL~1GM/VIAL~A~065286~00
1~AP~Mar 23, 2011~No~RX~EUROHEALTH INTERNATIONAL SARL
AZTREONAM~INJECTABLE;INJECTION~AZTREONAM~EUROHLTH INTL SARL~2GM/VIAL~A~065286~00
2~AP~Mar 23, 2011~No~RX~EUROHEALTH INTERNATIONAL SARL
AZTREONAM~INJECTABLE;INJECTION~AZTREONAM~FRESENIUS KABI USA~1GM/VIAL~A~065439~00
2~AP~Jun 18, 2010~No~RX~FRESENIUS KABI USA LLC
AZTREONAM~INJECTABLE;INJECTION~AZTREONAM~FRESENIUS KABI USA~2GM/VIAL~A~065439~00
3~AP~Jun 18, 2010~No~RX~FRESENIUS KABI USA LLC
AZTREONAM~INJECTABLE;INJECTION~AZTREONAM~FRESENIUS KABI USA~500MG/VIAL~A~065439~
001~~Jun 18, 2010~No~RX~FRESENIUS KABI USA LLC
BACITRACIN~INJECTABLE;INJECTION~BACIIM~X GEN PHARMS~50,000 UNITS/VIAL~A~064153~0
01~AP~May 9, 1997~No~RX~X GEN PHARMACEUTICALS INC
BACITRACIN~INJECTABLE;INJECTION~BACITRACIN~FRESENIUS KABI USA~50,000 UNITS/VIAL~
A~065116~001~AP~Dec 3, 2002~No~RX~FRESENIUS KABI USA LLC
BACITRACIN~INJECTABLE;INJECTION~BACITRACIN~PFIZER~50,000 UNITS/VIAL~A~060282~001
~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
BACITRACIN~INJECTABLE;INJECTION~BACITRACIN~PHARMACIA AND UPJOHN~10,000 UNITS/VIA
L~A~060733~001~~Approved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
BACITRACIN~INJECTABLE;INJECTION~BACITRACIN~PHARMACIA AND UPJOHN~50,000 UNITS/VIA
L~A~060733~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
BACITRACIN~INJECTABLE;INJECTION~BACITRACIN~SAGENT STRIDES~50,000 UNITS/VIAL~A~09
0211~001~AP~May 11, 2010~No~RX~SAGENT STRIDES LLC
BACITRACIN~INJECTABLE;INJECTION~BACITRACIN~XELLIA PHARMS APS~50,000 UNITS/VIAL~A
~203177~001~AP~Aug 25, 2014~No~RX~XELLIA PHARMACEUTICALS APS

SODIUM CHLORIDE~INJECTABLE;INJECTION~BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLAS
TIC CONTAINER~ABRAXIS PHARM~9MG/ML~A~088909~001~~Feb 7, 1985~No~DISCN~ABRAXIS PH
ARMACEUTICAL PRODUCTS
TIC CONTAINER~FRESENIUS KABI USA~9MG/ML~A~088911~001~AP~Feb 7, 1985~No~RX~FRESEN
IUS KABI USA LLC
TIC CONTAINER~HOSPIRA~9MG/ML~N~018800~001~AP~Oct 29, 1982~Yes~RX~HOSPIRA INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~BACTOCILL~GLAXOSMITHKLINE~EQ 1GM BASE/VIAL
~A~061334~006~~Mar 26, 1982~No~DISCN~GLAXOSMITHKLINE
~A~062736~001~~Dec 19, 1986~No~DISCN~GLAXOSMITHKLINE
OXACILLIN SODIUM~INJECTABLE;INJECTION~BACTOCILL~GLAXOSMITHKLINE~EQ 10GM BASE/VIA
L~A~061334~010~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
OXACILLIN SODIUM~INJECTABLE;INJECTION~BACTOCILL~GLAXOSMITHKLINE~EQ 500MG BASE/VI
AL~A~061334~009~~Mar 26, 1982~No~DISCN~GLAXOSMITHKLINE
OXACILLIN SODIUM~INJECTABLE;INJECTION~BACTOCILL IN PLASTIC CONTAINER~BAXTER HLTH
CARE~EQ 20MG BASE/ML~N~050640~001~~Oct 26, 1989~Yes~RX~BAXTER HEALTHCARE CORP
OXACILLIN SODIUM~INJECTABLE;INJECTION~BACTOCILL IN PLASTIC CONTAINER~BAXTER HLTH
CARE~EQ 40MG BASE/ML~N~050640~002~~Oct 26, 1989~Yes~RX~BAXTER HEALTHCARE CORP
SULFAMETHOXAZOLE; TRIMETHOPRIM~INJECTABLE;INJECTION~BACTRIM~MUTUAL PHARM~80MG/ML
;16MG/ML~N~018374~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTI
CAL CO INC
DIMERCAPROL~INJECTABLE;INJECTION~BAL~AKORN~10%~N~005939~001~~Approved Prior to J
an 1, 1982~Yes~RX~AKORN INC
DIPHENHYDRAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~BENADRYL~MCNEIL CONS~10MG/ML~
N~006146~001~~Approved Prior to Jan 1, 1982~No~DISCN~MCNEIL CONSUMER HEALTHCARE
DIPHENHYDRAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~BENADRYL~MCNEIL CONS~50MG/ML~
N~006146~002~~Approved Prior to Jan 1, 1982~No~DISCN~MCNEIL CONSUMER HEALTHCARE
DIPHENHYDRAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~BENADRYL PRESERVATIVE FREE~MC
NEIL CONS~50MG/ML~N~009486~001~~Approved Prior to Jan 1, 1982~No~DISCN~MCNEIL CO
NSUMER HEALTHCARE
DICYCLOMINE HYDROCHLORIDE~INJECTABLE;INJECTION~BENTYL~FOREST LABS INC~10MG/ML~N~
008370~001~AP~Oct 15, 1984~Yes~RX~FOREST LABORATORIES INC
DICYCLOMINE HYDROCHLORIDE~INJECTABLE;INJECTION~BENTYL PRESERVATIVE FREE~FOREST L
ABS INC~10MG/ML~N~008370~002~AP~Oct 15, 1984~Yes~RX~FOREST LABORATORIES INC
BENZTROPINE MESYLATE~INJECTABLE;INJECTION~BENZTROPINE MESYLATE~FRESENIUS KABI US
A~1MG/ML~A~090233~001~AP~Jul 28, 2009~No~RX~FRESENIUS KABI USA LLC
BENZTROPINE MESYLATE~INJECTABLE;INJECTION~BENZTROPINE MESYLATE~HIKMA FARMACEUTIC
A~1MG/ML~A~090287~001~AP~Aug 31, 2009~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
BENZTROPINE MESYLATE~INJECTABLE;INJECTION~BENZTROPINE MESYLATE~LUITPOLD~1MG/ML~A
~091152~001~AP~Mar 29, 2010~No~RX~LUITPOLD PHARMACEUTICALS INC
BENZTROPINE MESYLATE~INJECTABLE;INJECTION~BENZTROPINE MESYLATE~NAVINTA LLC~1MG/M
L~A~091525~001~AP~Feb 5, 2013~No~RX~NAVINTA LLC
NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE
HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E~INJECTABLE;INJECTION~BEROCCA PN~R
OCHE~50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.
8MG/ML;1.5MG/ML;1,650 IU/ML;5 IU/ML~N~006071~003~~Oct 10, 1985~No~DISCN~HOFFMANN
LA ROCHE INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~BERUBIGEN~PHARMACIA AND UPJOHN~1MG/ML~N~0067
CYANOCOBALAMIN~INJECTABLE;INJECTION~BETALIN 12~LILLY~0.1MG/ML~A~080855~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO

CYANOCOBALAMIN~INJECTABLE;INJECTION~BETALIN 12~LILLY~1MG/ML~A~080855~002~~Approv
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~BETALIN S~LILLY~100MG/ML~A~080853~00
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~BETAM
ETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE~LUITPOLD~3MG/ML;EQ 3MG BASE/
ML~A~090747~001~AB~Jul 31, 2009~No~RX~LUITPOLD PHARMACEUTICALS INC
BETAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~BETAMETHASONE SODIUM PHOSPHA
TE~WATSON LABS~EQ 3MG BASE/ML~A~085738~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~WATSON LABORATORIES INC
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE~INJECTABLE;INJECTION~BICILLIN C-R
~KING PHARMS~150,000 UNITS/ML;150,000 UNITS/ML~N~050138~002~~Approved Prior to J
an 1, 1982~Yes~RX~KING PHARMACEUTICALS INC
~KING PHARMS~300,000 UNITS/ML;300,000 UNITS/ML~N~050138~001~~Approved Prior to J
900/300~KING PHARMS~900,000 UNITS/2ML;300,000 UNITS/2ML~N~050138~003~~Approved
Prior to Jan 1, 1982~Yes~RX~KING PHARMACEUTICALS INC
PENICILLIN G BENZATHINE~INJECTABLE;INJECTION~BICILLIN L-A~KING PHARMS~300,000 UN
ITS/ML~N~050141~003~~Approved Prior to Jan 1, 1982~Yes~RX~KING PHARMACEUTICALS I
NC
PENICILLIN G BENZATHINE~INJECTABLE;INJECTION~BICILLIN L-A~KING PHARMS~600,000 UN
ITS/ML~N~050141~001~BC~Approved Prior to Jan 1, 1982~Yes~RX~KING PHARMACEUTICALS
INC
PENICILLIN G BENZATHINE~INJECTABLE;INJECTION~BICILLIN L-A~WYETH AYERST~300,000 U
NITS/ML~N~050131~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORA
TORIES
CARMUSTINE~INJECTABLE;INJECTION~BICNU~EMCURE PHARMS LTD~100MG/VIAL~N~017422~001~
~Approved Prior to Jan 1, 1982~Yes~RX~EMCURE PHARMACEUTICALS LTD
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~BIO-TROPIN~FERRING~4.8MG/VIAL~N~0197
74~001~~May 25, 1995~No~DISCN~FERRING PHARMACEUTICALS INC
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLENOXANE~BRISTOL MYERS SQUIBB~EQ 15 UNIT
S BASE/VIAL~N~050443~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS S
QUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLENOXANE~BRISTOL MYERS SQUIBB~EQ 30 UNIT
S BASE/VIAL~N~050443~002~~Sep 7, 1995~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEU
TICAL RESEARCH INSTITUTE
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~EUROHLTH INTL SARL~EQ 1
5 UNITS BASE/VIAL~A~065042~002~AP~Oct 17, 2001~No~RX~EUROHEALTH INTERNATIONAL SA
RL
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~EUROHLTH INTL SARL~EQ 3
0 UNITS BASE/VIAL~A~065042~001~AP~Oct 17, 2001~No~RX~EUROHEALTH INTERNATIONAL SA
RL
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~FRESENIUS KABI USA~EQ 1
5 UNITS BASE/VIAL~A~065185~001~AP~Jan 28, 2008~Yes~RX~FRESENIUS KABI USA LLC
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~FRESENIUS KABI USA~EQ 3
0 UNITS BASE/VIAL~A~065185~002~AP~Jan 28, 2008~Yes~RX~FRESENIUS KABI USA LLC
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~HOSPIRA~EQ 15 UNITS BAS
E/VIAL~A~065031~001~AP~Mar 10, 2000~No~RX~HOSPIRA INC
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~HOSPIRA~EQ 30 UNITS BAS
E/VIAL~A~065031~002~AP~Mar 10, 2000~No~RX~HOSPIRA INC
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~PHARMACHEMIE BV~EQ 15 U
NITS BASE/VIAL~A~065201~001~~Dec 13, 2007~No~DISCN~PHARMACHEMIE BV
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~TEVA PARENTERAL~EQ 15 U
NITS BASE/VIAL~A~064084~001~~Jun 1, 1996~No~DISCN~TEVA PARENTERAL MEDICINES INC
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~TEVA PARENTERAL~EQ 30 U
NITS BASE/VIAL~A~064084~002~~Jun 1, 1996~No~DISCN~TEVA PARENTERAL MEDICINES INC
BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~TEVA PHARMS USA~EQ 15 U
NITS BASE/VIAL~A~065033~001~AP~Jun 27, 2000~No~RX~TEVA PHARMACEUTICALS USA

BLEOMYCIN SULFATE~INJECTABLE;INJECTION~BLEOMYCIN SULFATE~TEVA PHARMS USA~EQ 30 U
NITS BASE/VIAL~A~065033~002~AP~Jun 27, 2000~No~RX~TEVA PHARMACEUTICALS USA
AMINO ACIDS~INJECTABLE;INJECTION~BRANCHAMIN 4%~BAXTER HLTHCARE~4% (4GM/100ML)~N~
018678~001~~Sep 28, 1984~No~DISCN~BAXTER HEALTHCARE CORP
AMINO ACIDS~INJECTABLE;INJECTION~BRANCHAMIN 4% IN PLASTIC CONTAINER~BAXTER HLTHC
ARE~4% (4GM/100ML)~N~018684~001~~Sep 28, 1984~No~DISCN~BAXTER HEALTHCARE CORP
TERBUTALINE SULFATE~INJECTABLE;INJECTION~BRETHINE~AAIPHARMA LLC~1MG/ML~N~018571~
001~~Approved Prior to Jan 1, 1982~No~DISCN~AAIPHARMA LLC
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~ABRAXIS PHARM~50MG/ML
~A~070134~001~~Apr 29, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~ABRAXIS PHARM~100MG/M
L~A~071298~001~~Feb 13, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~ASTRAZENECA~50MG/ML~A
~071151~001~~Aug 10, 1987~No~DISCN~ASTRAZENECA LP
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~HIKMA MAPLE ~50MG/ML~
A~070545~001~~May 14, 1986~No~DISCN~HIKMA MAPLE LTD
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~HIKMA MAPLE ~50MG/ML~
A~070546~001~~May 14, 1986~No~DISCN~HIKMA MAPLE LTD
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~HOSPIRA~50MG/ML~N~019
030~001~~Apr 29, 1986~No~DISCN~HOSPIRA WORLDWIDE, INC
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~HOSPIRA~50MG/ML~N~019
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~INTL MEDICATION~50MG/
ML~A~070119~001~~Apr 29, 1986~No~DISCN~INTERNATIONAL MEDICATION SYSTEM
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE~LUITPOLD~50MG/ML~A~07
0891~001~~Jul 26, 1988~No~DISCN~LUITPOLD PHARMACEUTICALS INC
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE IN DEXTROSE 5%~ABBOTT
~200MG/100ML~N~019005~002~~Apr 29, 1986~No~DISCN~ABBOTT LABORATORIES PHARMACEUTI
CAL PRODUCTS DIV
CAL PRODUCTS DIV
CAL PRODUCTS DIV
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLA
STIC CONTAINER~B BRAUN~100MG/100ML~N~019121~001~~Apr 29, 1986~Yes~RX~B BRAUN MED
ICAL INC
ICAL INC
ICAL INC
STIC CONTAINER~BAXTER HLTHCARE~200MG/100ML~N~019837~002~~Apr 12, 1989~No~DISCN~B
AXTER HEALTHCARE CORP
STIC CONTAINER~BAXTER HLTHCARE~400MG/100ML~N~019837~001~~Apr 12, 1989~No~DISCN~B
STIC CONTAINER~HOSPIRA INC~200MG/100ML~N~019008~002~~Apr 29, 1986~No~DISCN~HOSPI
RA INC
RA INC
RA INC
BRETYLIUM TOSYLATE~INJECTABLE;INJECTION~BRETYLOL~HOSPIRA~50MG/ML~N~017954~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
ESMOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~BREVIBLOC~BAXTER HLTHCARE~10MG/ML~N~0
19386~003~~Aug 15, 1988~No~DISCN~BAXTER HEALTHCARE CORP
19386~006~AP~Feb 25, 2003~Yes~RX~BAXTER HEALTHCARE CORP
19386~007~~May 28, 2003~No~DISCN~BAXTER HEALTHCARE CORP
ESMOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~BREVIBLOC DOUBLE STRENGTH IN PLASTIC
CONTAINER~BAXTER HLTHCARE~2GM/100ML~N~019386~005~~Jan 27, 2003~Yes~RX~BAXTER HEA
LTHCARE CORP
ESMOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~BREVIBLOC IN PLASTIC CONTAINER~BAXTER
HLTHCARE~1GM/100ML~N~019386~004~~Feb 16, 2001~Yes~RX~BAXTER HEALTHCARE CORP
METHOHEXITAL SODIUM~INJECTABLE;INJECTION~BREVITAL SODIUM~PAR STERILE PRODUCTS~2.
5GM/VIAL~N~011559~002~~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUCTS
LLC
METHOHEXITAL SODIUM~INJECTABLE;INJECTION~BREVITAL SODIUM~PAR STERILE PRODUCTS~5G
M/VIAL~N~011559~003~~Approved Prior to Jan 1, 1982~No~DISCN~PAR STERILE PRODUCTS
LLC
METHOHEXITAL SODIUM~INJECTABLE;INJECTION~BREVITAL SODIUM~PAR STERILE PRODUCTS~20
0MG/VIAL~N~011559~004~~Dec 21, 2012~Yes~RX~PAR STERILE PRODUCTS LLC
METHOHEXITAL SODIUM~INJECTABLE;INJECTION~BREVITAL SODIUM~PAR STERILE PRODUCTS~50
0MG/VIAL~N~011559~001~~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUCTS
LLC
TERBUTALINE SULFATE~INJECTABLE;INJECTION~BRICANYL~SANOFI AVENTIS US~1MG/ML~N~017
GENTAMICIN SULFATE~INJECTABLE;INJECTION~BRISTAGEN~BRISTOL~EQ 40MG BASE/ML~A~0622
88~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRIS
TOL MYERS CO
BROMPHENIRAMINE MALEATE~INJECTABLE;INJECTION~BROMPHENIRAMINE MALEATE~WATSON LABS
~10MG/ML~A~083821~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIE
S INC
BROMPHENIRAMINE MALEATE~INJECTABLE;INJECTION~BROMPHENIRAMINE MALEATE~WATSON LABS
~100MG/ML~A~083820~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORI
ES INC
BUMETANIDE~INJECTABLE;INJECTION~BUMETANIDE~BEDFORD~0.25MG/ML~A~074441~001~AP~Jan
27, 1995~Yes~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
BUMETANIDE~INJECTABLE;INJECTION~BUMETANIDE~HIKMA MAPLE ~0.25MG/ML~A~079196~001~A
P~Apr 30, 2008~No~RX~HIKMA MAPLE LTD
BUMETANIDE~INJECTABLE;INJECTION~BUMETANIDE~HOSPIRA~0.25MG/ML~A~074160~001~~Oct 3
0, 1997~No~DISCN~HOSPIRA INC
BUMETANIDE~INJECTABLE;INJECTION~BUMETANIDE~HOSPIRA~0.25MG/ML~A~074332~001~AP~Oct
31, 1994~No~RX~HOSPIRA INC
BUMETANIDE~INJECTABLE;INJECTION~BUMETANIDE~TEVA PARENTERAL~0.25MG/ML~A~074613~00
1~~Nov 18, 1997~No~DISCN~TEVA PARENTERAL MEDICINES INC
BUMETANIDE~INJECTABLE;INJECTION~BUMEX~VALIDUS PHARMS INC~0.25MG/ML~N~018226~001~
~Feb 28, 1983~No~DISCN~VALIDUS PHARMACEUTICALS INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPIVACAINE HYDROCHLORIDE~HOSPIRA
~0.25%~A~070583~001~AP~Feb 17, 1987~No~RX~HOSPIRA INC
~0.25%~A~070586~001~AP~Mar 3, 1987~No~RX~HOSPIRA INC
~0.25%~N~018053~002~AP~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC

~0.75%~A~070587~001~~Mar 3, 1987~No~DISCN~HOSPIRA INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPIVACAINE HYDROCHLORIDE~SAGENT
AGILA~0.25%~A~091503~001~AP~Oct 18, 2011~No~RX~SAGENT AGILA LLC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPIVACAINE HYDROCHLORIDE~SAGENT
AGILA~0.5%~A~091503~002~AP~Oct 18, 2011~No~RX~SAGENT AGILA LLC
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE~INJECTABLE;INJECTION~BUPIVACAINE HYDROCHL
ORIDE AND EPINEPHRINE~HOSPIRA~0.25%;0.005MG/ML~A~071165~001~~Jun 16, 1988~Yes~RX
~HOSPIRA INC
ORIDE AND EPINEPHRINE~HOSPIRA~0.25%;0.005MG/ML~A~071166~001~~Jun 16, 1988~No~DIS
CN~HOSPIRA INC
ORIDE AND EPINEPHRINE~HOSPIRA~0.25%;0.005MG/ML~A~071167~001~~Jun 16, 1988~No~RX~
HOSPIRA INC
ORIDE AND EPINEPHRINE~HOSPIRA~0.5%;0.005MG/ML~A~071168~001~AP~Jun 16, 1988~Yes~R
X~HOSPIRA INC
ORIDE AND EPINEPHRINE~HOSPIRA~0.5%;0.005MG/ML~A~071169~001~~Jun 16, 1988~No~DISC
N~HOSPIRA INC
ORIDE AND EPINEPHRINE~HOSPIRA~0.5%;0.005MG/ML~A~071170~001~AP~Jun 16, 1988~No~RX
~HOSPIRA INC
ORIDE AND EPINEPHRINE~HOSPIRA~0.75%;0.005MG/ML~A~071171~001~~Jun 16, 1988~No~DIS
CN~HOSPIRA INC
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~BUPIVACAI
NE HYDROCHLORIDE AND EPINEPHRINE~SEPTODONT~0.5%;0.0091MG/ML~A~077250~001~AP~Sep
27, 2006~No~RX~SEPTODONT INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPIVACAINE HYDROCHLORIDE KIT~HOS
PIRA~0.075%~N~019978~001~~Sep 3, 1992~No~DISCN~HOSPIRA INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPIVACAINE HYDROCHLORIDE PRESERV
ATIVE FREE~AUROBINDO PHARMA LTD~0.25%~A~203895~001~AP~Nov 5, 2013~No~RX~AUROBIND
O PHARMA LTD
ATIVE FREE~AUROBINDO PHARMA LTD~0.5%~A~203895~002~AP~Nov 5, 2013~No~RX~AUROBINDO
PHARMA LTD
ATIVE FREE~AUROBINDO PHARMA LTD~0.75%~A~203895~003~AP~Nov 5, 2013~No~RX~AUROBIND
O PHARMA LTD
ATIVE FREE~INTL MEDICATED~0.25%~A~076012~001~~Jan 9, 2002~No~DISCN~INTERNATIONAL
MEDICATED SYSTEMS LTD

ATIVE FREE~SAGENT AGILA~0.25%~A~091487~002~AP~Oct 18, 2011~No~RX~SAGENT AGILA LL
C
ATIVE FREE~SAGENT AGILA~0.5%~A~091487~001~AP~Oct 18, 2011~No~RX~SAGENT AGILA LLC
ATIVE FREE~SAGENT AGILA~0.75%~A~091487~003~AP~Oct 18, 2011~No~RX~SAGENT AGILA LL
C
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~BUPIVACAI
NE HYDROCHLORIDE W/EPINEPHRINE~HOSPIRA~0.5%;0.0091MG/ML~N~022046~001~AP~Jul 13,
BUPRENORPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPRENEX~RECKITT BENCKISER~EQ 0
.3MG BASE/ML~N~018401~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~RECKITT BENCKI
SER PHARMACEUTICALS INC
BUPRENORPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPRENORPHINE HYDROCHLORIDE~EUR
OHLTH INTL SARL~EQ 0.3MG BASE/ML~A~076931~001~AP~Mar 2, 2005~No~RX~EUROHEALTH IN
TERNATIONAL SARL
BUPRENORPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPRENORPHINE HYDROCHLORIDE~HOS
PIRA~EQ 0.3MG BASE/ML~A~074137~001~AP~Jun 3, 1996~No~RX~HOSPIRA INC
BUPRENORPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~BUPRENORPHINE HYDROCHLORIDE~LUI
TPOLD~EQ 0.3MG BASE/ML~A~078331~001~AP~Mar 27, 2007~No~RX~LUITPOLD PHARMACEUTICA
LS INC
BUSULFAN~INJECTABLE;INJECTION~BUSULFEX~OTSUKA PHARM~6MG/ML~N~020954~001~~Feb 4,
1999~Yes~RX~OTSUKA PHARMACEUTICAL CO LTD
BUTORPHANOL TARTRATE~INJECTABLE;INJECTION~BUTORPHANOL TARTRATE~APOTEX INC~2MG/ML
~A~075697~001~~Oct 23, 2001~No~DISCN~APOTEX INC
BUTORPHANOL TARTRATE~INJECTABLE;INJECTION~BUTORPHANOL TARTRATE~BEDFORD~2MG/ML~A~
075046~001~AP~Aug 12, 1998~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES
INC
BUTORPHANOL TARTRATE~INJECTABLE;INJECTION~BUTORPHANOL TARTRATE~HIKMA FARMACEUTIC
A~1MG/ML~A~078400~001~AP~May 1, 2009~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
A~2MG/ML~A~078247~001~~Apr 29, 2009~No~DISCN~HIKMA FARMACEUTICA SA
A~2MG/ML~A~078400~002~AP~May 1, 2009~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
BUTORPHANOL TARTRATE~INJECTABLE;INJECTION~BUTORPHANOL TARTRATE~HOSPIRA~1MG/ML~A~
BUTORPHANOL TARTRATE~INJECTABLE;INJECTION~BUTORPHANOL TARTRATE PRESERVATIVE FREE
~APOTEX INC~1MG/ML~A~075695~001~~Oct 23, 2001~No~DISCN~APOTEX INC
~APOTEX INC~2MG/ML~A~075695~002~~Oct 23, 2001~No~DISCN~APOTEX INC
~BEDFORD~1MG/ML~A~075045~001~AP~Aug 12, 1998~No~RX~BEDFORD LABORATORIES DIV BEN
VENUE LABORATORIES INC
~BEDFORD~2MG/ML~A~075045~002~AP~Aug 12, 1998~No~RX~BEDFORD LABORATORIES DIV BEN
~HOSPIRA~1MG/ML~A~074620~001~~Jan 22, 1997~No~DISCN~HOSPIRA INC

~HOSPIRA~1MG/ML~A~074626~001~AP~Jan 23, 1997~No~RX~HOSPIRA INC
~HOSPIRA~1MG/ML~A~075170~001~~Sep 28, 1998~No~DISCN~HOSPIRA WORLDWIDE, INC
~HOSPIRA~2MG/ML~A~074620~002~~Jan 22, 1997~No~DISCN~HOSPIRA INC
~HOSPIRA~2MG/ML~A~074626~002~AP~Jan 23, 1997~No~RX~HOSPIRA INC
~HOSPIRA~2MG/ML~A~075170~002~~Sep 28, 1998~No~DISCN~HOSPIRA WORLDWIDE, INC
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~CALAN~GD SEARLE LLC~2.5MG/ML~N~0189
25~001~~Mar 30, 1984~No~DISCN~GD SEARLE LLC
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~CALAN~GD SEARLE LLC~2.5MG/ML~N~0190
38~001~~Mar 30, 1984~No~DISCN~GD SEARLE LLC
CALCITRIOL~INJECTABLE;INJECTION~CALCIJEX~ABBVIE~0.001MG/ML~N~018874~001~AP~Sep 2
CALCITRIOL~INJECTABLE;INJECTION~CALCIJEX~ABBVIE~0.002MG/ML~N~018874~002~AP~Sep 2
CALCITONIN SALMON~INJECTABLE;INJECTION~CALCIMAR~SANOFI AVENTIS US~200 IU/ML~N~01
CALCITONIN SALMON~INJECTABLE;INJECTION~CALCIMAR~SANOFI AVENTIS US~400 IU/VIAL~N~
HEPARIN CALCIUM~INJECTABLE;INJECTION~CALCIPARINE~SANOFI AVENTIS US~25,000 UNITS/
ML~N~018237~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
CALCITONIN SALMON~INJECTABLE;INJECTION~CALCITONIN-SALMON~ASTRAZENECA~200 IU/ML~A
~073690~001~~Apr 14, 1995~No~DISCN~ASTRAZENECA LP
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~AKORN~0.001MG/ML~A~078066~001~AP~Jan
29, 2008~No~RX~AKORN INC
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~AKORN~0.002MG/ML~A~078066~002~AP~Jan
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~FRESENIUS KABI USA~0.001MG/ML~A~07583
6~001~AP~Dec 31, 2002~No~RX~FRESENIUS KABI USA LLC
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~FRESENIUS KABI USA~0.002MG/ML~A~07583
6~002~AP~Dec 31, 2002~No~RX~FRESENIUS KABI USA LLC
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~FRESENIUS MEDCL~0.001MG/ML~A~075766~0
01~AP~Feb 20, 2003~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~FRESENIUS MEDCL~0.002MG/ML~A~075766~0
02~AP~Feb 20, 2003~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~HOSPIRA~0.001MG/ML~A~075816~001~~Jan
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~HOSPIRA~0.002MG/ML~A~075816~002~~Jan
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~LUITPOLD~0.001MG/ML~A~075746~001~AP~S
ep 26, 2003~No~RX~LUITPOLD PHARMACEUTICALS INC
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~LUITPOLD~0.002MG/ML~A~075746~002~AP~S
ep 26, 2003~No~RX~LUITPOLD PHARMACEUTICALS INC
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~ROCKWELL MEDCL~0.001MG/ML~A~076206~00
1~AP~Sep 17, 2003~No~RX~ROCKWELL MEDICAL TECHNOLOGIES INC
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~SAGENT PHARMS~0.001MG/ML~A~077102~001
~AP~Feb 8, 2006~No~RX~SAGENT PHARMACEUTICALS INC
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~TEVA PARENTERAL~0.001MG/ML~A~075823~0
01~~Mar 31, 2003~No~DISCN~TEVA PARENTERAL MEDICINES INC
CALCITRIOL~INJECTABLE;INJECTION~CALCITRIOL~TEVA PARENTERAL~0.002MG/ML~A~075823~0
02~~Mar 31, 2003~No~DISCN~TEVA PARENTERAL MEDICINES INC
CALCIUM CHLORIDE~INJECTABLE;INJECTION~CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER~
HOSPIRA~100MG/ML~N~021117~001~~Jan 28, 2000~Yes~RX~HOSPIRA INC
EDETATE CALCIUM DISODIUM~INJECTABLE;INJECTION~CALCIUM DISODIUM VERSENATE~MEDICIS
~200MG/ML~N~008922~001~~Approved Prior to Jan 1, 1982~Yes~RX~MEDICIS PHARMACEUTI
CAL CORP
CALCIUM GLUCEPTATE~INJECTABLE;INJECTION~CALCIUM GLUCEPTATE~ABBOTT~EQ 90MG CALCIU
M/5ML~A~080001~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES P

HARMACEUTICAL PRODUCTS DIV
CALCIUM GLUCEPTATE~INJECTABLE;INJECTION~CALCIUM GLUCEPTATE~ABBOTT~EQ 90MG CALCIU
M/5ML~A~083159~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES P
CALCIUM GLUCEPTATE~INJECTABLE;INJECTION~CALCIUM GLUCEPTATE~ABRAXIS PHARM~EQ 90MG
CALCIUM/5ML~A~089373~001~~Apr 30, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CALCIUM GLUCEPTATE~INJECTABLE;INJECTION~CALCIUM GLUCEPTATE~LILLY~EQ 90MG CALCIUM
/5ML~N~006470~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~CAMPTOSAR~PFIZER INC~40MG/2ML (20M
G/ML)~N~020571~001~AP~Jun 14, 1996~Yes~RX~PFIZER INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~CAMPTOSAR~PFIZER INC~100MG/5ML (20
MG/ML)~N~020571~002~AP~Jun 14, 1996~Yes~RX~PFIZER INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~CAMPTOSAR~PFIZER INC~300MG/15ML (2
0MG/ML)~N~020571~003~~Aug 5, 2010~Yes~RX~PFIZER INC
CAPREOMYCIN SULFATE~INJECTABLE;INJECTION~CAPASTAT SULFATE~AKORN~EQ 1GM BASE/VIAL
~N~050095~001~~Approved Prior to Jan 1, 1982~Yes~RX~AKORN INC
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CARBOCAINE~EASTMAN KODAK~3%~N~012
125~003~~Approved Prior to Jan 1, 1982~No~DISCN~EASTMAN KODAK CO
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CARBOCAINE~HOSPIRA~1%~N~012250~00
1~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CARBOCAINE~HOSPIRA~1.5%~N~012250~
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CARBOCAINE~HOSPIRA~2%~N~012250~00
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CARBOCAINE W/ NEOCOBEFRIN~EASTMAN KODAK~0.05MG/ML;2%~N~012125~002~~Approved Prior to Jan 1, 1982~
No~DISCN~EASTMAN KODAK CO
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~CIPLA LTD~50MG/VIAL~A~077383~001~~J
an 27, 2006~No~DISCN~CIPLA LTD
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~CIPLA LTD~150MG/VIAL~A~077383~002~~
Jan 27, 2006~No~DISCN~CIPLA LTD
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~CIPLA LTD~450MG/VIAL~A~077383~003~~
Jan 27, 2006~No~DISCN~CIPLA LTD
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~EUROHLTH INTL SARL~50MG/VIAL~A~0760
99~001~~Oct 14, 2004~No~DISCN~EUROHEALTH INTERNATIONAL SARL
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~FRESENIUS KABI USA~50MG/VIAL~A~0762
35~001~~Oct 14, 2004~No~DISCN~FRESENIUS KABI USA LLC
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~HOSPIRA~50MG/VIAL~A~076473~001~~Oct
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~HOSPIRA~150MG/VIAL~A~076473~002~~Oc
t 27, 2004~No~DISCN~HOSPIRA INC
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~HOSPIRA~450MG/VIAL~A~076473~003~~Oc
t 27, 2004~No~DISCN~HOSPIRA INC
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~ONCO THERAPIES LTD~50MG/VIAL~A~0915
10~001~~May 29, 2012~No~DISCN~ONCO THERAPIES LTD
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~PLIVA~50MG/VIAL~A~076602~001~~Nov 1
6, 2004~No~DISCN~PLIVA INC
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~PLIVA~150MG/VIAL~A~076602~002~~Nov
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~PLIVA~450MG/VIAL~A~076602~003~~Nov
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~SANDOZ~50MG/VIAL~A~076959~001~~Mar
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~WATSON LABS~50MG/VIAL~A~076162~001~
~Oct 14, 2004~No~DISCN~WATSON LABORATORIES INC
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~WATSON LABS~150MG/VIAL~A~076162~002
~~Oct 14, 2004~No~DISCN~WATSON LABORATORIES INC
CARBOPLATIN~INJECTABLE;INJECTION~CARBOPLATIN~WATSON LABS~450MG/VIAL~A~076162~003
~~Oct 14, 2004~No~DISCN~WATSON LABORATORIES INC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INJECTION~CARDENE~CHIESI USA INC~25MG/10ML
(2.5MG/ML)~N~019734~001~AP~Jan 30, 1992~Yes~RX~CHIESI USA INC
RUBIDIUM CHLORIDE RB-82~INJECTABLE;INJECTION~CARDIOGEN-82~BRACCO~N/A~N~019414~00
1~~Dec 29, 1989~No~RX~BRACCO DIAGNOSTICS INC
DIATRIZOATE MEGLUMINE~INJECTABLE;INJECTION~CARDIOGRAFIN~BRACCO~85%~N~011620~002~
~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
TECHNETIUM TC-99M SESTAMIBI KIT~INJECTABLE;INJECTION~CARDIOLITE~LANTHEUS MEDCL~N
/A~N~019785~001~AP~Dec 21, 1990~Yes~RX~LANTHEUS MEDICAL IMAGING INC
TECHNETIUM TC-99M TEBOROXIME KIT~INJECTABLE;INJECTION~CARDIOTEC~BRACCO~N/A~N~019
928~001~~Dec 19, 1990~No~DISCN~BRACCO DIAGNOSTICS INC
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~CARDIZEM~BIOVAIL~100MG/VIAL~N~02079
2~001~~Sep 5, 1997~No~DISCN~BIOVAIL LABORATORIES INC
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~CARDIZEM~BIOVAIL LABS INTL~5MG/ML~N
~020027~001~~Oct 24, 1991~No~DISCN~BIOVAIL LABORATORIES INTERNATIONAL SRL
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~CARDIZEM~BIOVAIL LABS INTL~25MG/VIA
L **Federal Register determination that product was not discontinued or withdraw
n for safety or efficacy reasons**~N~020027~003~~Aug 18, 1995~No~DISCN~BIOVAIL L
ABORATORIES INTERNATIONAL SRL
LEVOCARNITINE~INJECTABLE;INJECTION~CARNITOR~SIGMA TAU~200MG/ML~N~020182~001~AP~D
ec 16, 1992~Yes~RX~SIGMA TAU PHARMACEUTICALS INC
ALPROSTADIL~INJECTABLE;INJECTION~CAVERJECT~PFIZER~0.005MG/ML~N~020755~001~~Oct 3
1, 1997~No~DISCN~PFIZER INC
ALPROSTADIL~INJECTABLE;INJECTION~CAVERJECT~PFIZER~0.01MG/ML~N~020755~002~~Oct 1,
1997~No~DISCN~PFIZER INC
ALPROSTADIL~INJECTABLE;INJECTION~CAVERJECT~PFIZER~0.02MG/ML~N~020755~003~~Oct 1,
1997~No~DISCN~PFIZER INC
ALPROSTADIL~INJECTABLE;INJECTION~CAVERJECT~PHARMACIA AND UPJOHN~0.005MG/VIAL~N~0
20379~003~~Jun 27, 1996~No~RX~PHARMACIA AND UPJOHN CO
0379~001~AP~Jul 6, 1995~No~RX~PHARMACIA AND UPJOHN CO
0379~002~AP~Jul 6, 1995~Yes~RX~PHARMACIA AND UPJOHN CO
0379~004~AP~May 19, 1997~Yes~RX~PHARMACIA AND UPJOHN CO
ALPROSTADIL~INJECTABLE;INJECTION~CAVERJECT IMPULSE~PHARMACIA AND UPJOHN~0.01MG/V
IAL~N~021212~001~~Jun 11, 2002~No~RX~PHARMACIA AND UPJOHN CO
ALPROSTADIL~INJECTABLE;INJECTION~CAVERJECT IMPULSE~PHARMACIA AND UPJOHN~0.02MG/V
IAL~N~021212~002~~Jun 11, 2002~No~RX~PHARMACIA AND UPJOHN CO
DESLANOSIDE~INJECTABLE;INJECTION~CEDILANID-D~NOVARTIS~0.2MG/ML~N~009282~002~~App
roved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEFADYL~APOTHECON~EQ 1GM BASE/VIAL~A~0617
69~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS S
QUIBB
24~001~~Dec 23, 1986~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB

61~002~~Sep 20, 1988~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEFADYL~APOTHECON~EQ 1GM BASE/VIAL~N~0504
QUIBB
QUIBB
24~002~~Dec 23, 1986~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
QUIBB
QUIBB
QUIBB
SQUIBB
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEFADYL~APOTHECON~EQ 500MG BASE/VIAL~A~06
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEFADYL~APOTHECON~EQ 500MG BASE/VIAL~N~05
SQUIBB
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN AND DEXTROSE~B BRAUN~EQ 1GM BASE
/VIAL~N~050779~002~~Jul 27, 2000~Yes~RX~B BRAUN MEDICAL INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN AND DEXTROSE~B BRAUN~EQ 2GM BASE
/VIAL~N~050779~003~~Jan 13, 2012~No~RX~B BRAUN MEDICAL INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN AND DEXTROSE~B BRAUN~EQ 500MG BA
SE/VIAL~N~050779~001~~Jul 27, 2000~No~DISCN~B BRAUN MEDICAL INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~ABRAXIS PHARM~EQ 1GM BASE
/VIAL~A~062688~003~~Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~ABRAXIS PHARM~EQ 10GM BAS
E/VIAL~A~062688~004~~Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~ABRAXIS PHARM~EQ 20GM BAS
E/VIAL~A~062688~005~~Aug 3, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~ABRAXIS PHARM~EQ 500MG BA
SE/VIAL~A~062688~002~~Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~ACS DOBFAR~EQ 1GM BASE/VI
AL~A~065303~002~AP~Oct 22, 2008~No~RX~ACS DOBFAR SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~ACS DOBFAR~EQ 10GM BASE/V
IAL~A~065306~001~AP~Oct 22, 2008~No~RX~ACS DOBFAR SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~ACS DOBFAR~EQ 20GM BASE/V
IAL~A~065306~002~AP~Aug 18, 2014~No~RX~ACS DOBFAR SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~ACS DOBFAR~EQ 500MG BASE/
VIAL~A~065303~001~AP~Oct 22, 2008~No~RX~ACS DOBFAR SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~AUROBINDO PHARMA~EQ 1GM B
ASE/VIAL~A~065395~002~~Aug 8, 2008~No~DISCN~AUROBINDO PHARMA LTD
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~AUROBINDO PHARMA~EQ 500MG
BASE/VIAL~A~065395~001~~Aug 8, 2008~No~DISCN~AUROBINDO PHARMA LTD
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~BEDFORD~EQ 1GM BASE/VIAL~
A~062894~003~~Jul 21, 1988~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORATOR
IES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~BEDFORD~EQ 5GM BASE/VIAL~
A~062894~004~~Jul 21, 1988~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORATOR
IES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~BEDFORD~EQ 10GM BASE/VIAL
~A~062894~005~~Jul 21, 1988~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORATO
RIES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~BEDFORD~EQ 250MG BASE/VIA
L~A~062894~001~~Jul 21, 1988~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORAT
ORIES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~BEDFORD~EQ 500MG BASE/VIA
L~A~062894~002~~Jul 21, 1988~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORAT
ORIES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~CEPHAZONE PHARMA~EQ 1GM B
ASE/VIAL~A~065280~002~~Mar 18, 2009~No~DISCN~CEPHAZONE PHARMA LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~CEPHAZONE PHARMA~EQ 10GM
BASE/VIAL~A~065295~001~~Mar 18, 2009~No~DISCN~CEPHAZONE PHARMA LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~CEPHAZONE PHARMA~EQ 20GM
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~CEPHAZONE PHARMA~EQ 500MG
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~FACTA FARMA~EQ 1GM BASE/V
IAL~A~063207~001~AP~Dec 27, 1991~No~RX~FACTA FARMACEUTICI SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~FACTA FARMA~EQ 10GM BASE/
VIAL~A~063209~001~AP~Dec 27, 1991~No~RX~FACTA FARMACEUTICI SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~FACTA FARMA~EQ 20GM BASE/
VIAL~A~063209~002~AP~Apr 30, 1999~Yes~RX~FACTA FARMACEUTICI SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~FACTA FARMA~EQ 500MG BASE
/VIAL~A~063214~001~AP~Dec 27, 1991~No~RX~FACTA FARMACEUTICI SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~FRESENIUS KABI USA~EQ 1GM
BASE/VIAL~A~064169~002~~Aug 14, 1998~No~DISCN~FRESENIUS KABI USA LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~FRESENIUS KABI USA~EQ 10G
M BASE/VIAL~A~064170~001~~Mar 18, 1998~No~DISCN~FRESENIUS KABI USA LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~FRESENIUS KABI USA~EQ 20G
M BASE/VIAL~A~064170~002~~Mar 18, 1998~No~DISCN~FRESENIUS KABI USA LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~FRESENIUS KABI USA~EQ 500
MG BASE/VIAL~A~064169~001~~Aug 14, 1998~No~DISCN~FRESENIUS KABI USA LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~GLAXOSMITHKLINE~EQ 1GM BA
SE/VIAL~A~064033~001~~Oct 31, 1993~No~DISCN~GLAXOSMITHKLINE
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA FARMACEUTICA~EQ 1GM
BASE/VIAL~A~065047~002~AP~Sep 18, 2001~No~RX~HIKMA FARMACEUTICA PORTUGAL LDA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA FARMACEUTICA~EQ 10G
M BASE/VIAL~A~065143~001~AP~Oct 18, 2004~No~RX~HIKMA FARMACEUTICA PORTUGAL LDA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA FARMACEUTICA~EQ 500
MG BASE/VIAL~A~065047~001~AP~Sep 18, 2001~No~RX~HIKMA FARMACEUTICA PORTUGAL LDA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA MAPLE ~EQ 1GM BASE/
VIAL~A~062807~003~~Jan 12, 1988~No~DISCN~HIKMA MAPLE LTD
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA MAPLE ~EQ 5GM BASE/
VIAL~A~062807~004~~Jan 12, 1988~No~DISCN~HIKMA MAPLE LTD
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA MAPLE ~EQ 10GM BASE
/VIAL~A~062807~005~~Jan 12, 1988~No~DISCN~HIKMA MAPLE LTD
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA MAPLE ~EQ 20GM BASE
/VIAL~A~062807~006~~Jan 12, 1988~No~DISCN~HIKMA MAPLE LTD
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA MAPLE ~EQ 250MG BAS
E/VIAL~A~062807~001~~Jan 12, 1988~No~DISCN~HIKMA MAPLE LTD
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HIKMA MAPLE ~EQ 500MG BAS
E/VIAL~A~062807~002~~Jan 12, 1988~No~DISCN~HIKMA MAPLE LTD
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HOSPIRA INC~EQ 1GM BASE/V
IAL~A~065226~002~AP~Apr 21, 2005~Yes~RX~HOSPIRA INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HOSPIRA INC~EQ 1GM BASE/V
IAL~A~065244~001~AP~Aug 12, 2005~Yes~RX~HOSPIRA INC

CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HOSPIRA INC~EQ 10GM BASE/
VIAL~A~065247~001~AP~Aug 12, 2005~Yes~RX~HOSPIRA INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~HOSPIRA INC~EQ 500MG BASE
/VIAL~A~065226~001~AP~Apr 21, 2005~Yes~RX~HOSPIRA INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~SAMSON MEDCL~EQ 100GM BAS
E/VIAL~A~065141~001~~Nov 29, 2006~Yes~RX~SAMSON MEDICAL TECHNOLOGIES LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~SAMSON MEDCL~EQ 300GM BAS
E/VIAL~A~065141~002~~Nov 29, 2006~Yes~RX~SAMSON MEDICAL TECHNOLOGIES LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~SANDOZ~EQ 1GM BASE/VIAL~A
~062831~002~AP~Dec 9, 1988~No~RX~SANDOZ INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~SANDOZ~EQ 1GM BASE/VIAL~A
~065345~001~AP~May 9, 2007~No~RX~SANDOZ INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~SANDOZ~EQ 10GM BASE/VIAL~
A~062831~003~AP~Sep 25, 1992~No~RX~SANDOZ INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~SANDOZ~EQ 500MG BASE/VIAL
~A~062831~001~AP~Dec 9, 1988~No~RX~SANDOZ INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~STERI PHARMA~EQ 1GM BASE/
VIAL~A~063208~001~~Dec 27, 1991~No~DISCN~STERI PHARMA LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~STERI PHARMA~EQ 500MG BAS
E/VIAL~A~063216~001~~Dec 27, 1991~No~DISCN~STERI PHARMA LLC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~TEVA PHARMS~EQ 1GM BASE/V
IAL~A~063016~003~~Mar 14, 1989~No~DISCN~TEVA PHARMACEUTICALS USA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~TEVA PHARMS~EQ 5GM BASE/V
IAL~A~063018~001~~Mar 5, 1990~No~DISCN~TEVA PHARMACEUTICALS USA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~TEVA PHARMS~EQ 10GM BASE/
VIAL~A~063018~002~~Mar 5, 1990~No~DISCN~TEVA PHARMACEUTICALS USA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~TEVA PHARMS~EQ 250MG BASE
/VIAL~A~063016~001~~Mar 14, 1989~No~DISCN~TEVA PHARMACEUTICALS USA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~TEVA PHARMS~EQ 500MG BASE
/VIAL~A~063016~002~~Mar 14, 1989~No~DISCN~TEVA PHARMACEUTICALS USA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~WATSON LABS INC~EQ 1GM BA
SE/VIAL~A~062988~003~~Dec 29, 1989~No~DISCN~WATSON LABORATORIES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~WATSON LABS INC~EQ 5GM BA
SE/VIAL~A~062989~001~~Dec 29, 1989~No~DISCN~WATSON LABORATORIES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~WATSON LABS INC~EQ 10GM B
ASE/VIAL~A~062989~002~~Dec 29, 1989~No~DISCN~WATSON LABORATORIES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~WATSON LABS INC~EQ 20GM B
ASE/VIAL~A~062989~003~~Dec 29, 1989~No~DISCN~WATSON LABORATORIES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~WATSON LABS INC~EQ 250MG
BASE/VIAL~A~062988~001~~Dec 29, 1989~No~DISCN~WATSON LABORATORIES INC
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~CEFAZOLIN SODIUM~WATSON LABS INC~EQ 500MG
BASE/VIAL~A~062988~002~~Dec 29, 1989~No~DISCN~WATSON LABORATORIES INC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME AND DEXTROSE IN DUPLEX CONT
AINER~B BRAUN~EQ 1GM BASE/VIAL~N~050821~001~~May 6, 2010~No~RX~B BRAUN MEDICAL I
NC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME AND DEXTROSE IN DUPLEX CONT
AINER~B BRAUN~EQ 2GM BASE/VIAL~N~050821~002~~May 6, 2010~No~RX~B BRAUN MEDICAL I
NC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME HYDROCHLORIDE~ACS DOBFAR~EQ
1GM BASE/VIAL~A~065441~001~AP~Mar 20, 2008~No~RX~ACS DOBFAR SPA
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME HYDROCHLORIDE~ACS DOBFAR~EQ
2GM BASE/VIAL~A~065441~002~AP~Mar 20, 2008~No~RX~ACS DOBFAR SPA
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME HYDROCHLORIDE~HOSPIRA INC~E
Q 1GM BASE/VIAL~A~065369~002~AP~Jun 18, 2007~No~RX~HOSPIRA INC
Q 1GM BASE/VIAL~A~202268~001~AP~Jul 30, 2012~No~RX~HOSPIRA INC
Q 2GM BASE/VIAL~A~065369~003~AP~Jun 18, 2007~No~RX~HOSPIRA INC
Q 2GM BASE/VIAL~A~202268~002~AP~Jul 30, 2012~No~RX~HOSPIRA INC

Q 500MG BASE/VIAL~A~065369~001~AP~Jun 18, 2007~No~RX~HOSPIRA INC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME HYDROCHLORIDE~SANDOZ~EQ 1GM
BASE/VIAL~A~090291~002~~Dec 21, 2010~No~DISCN~SANDOZ INC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME HYDROCHLORIDE~SANDOZ~EQ 2GM
BASE/VIAL~A~090291~003~~Dec 21, 2010~No~DISCN~SANDOZ INC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME HYDROCHLORIDE~SANDOZ~EQ 500
MG BASE/VIAL~A~090291~001~~Dec 21, 2010~No~DISCN~SANDOZ INC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME IN PLASTIC CONTAINER~BAXTER
HLTHCARE~EQ 1GM BASE/50ML (EQ 20MG BASE/ML)~N~050817~001~~Aug 5, 2008~Yes~RX~BA
XTER HEALTHCARE CORP
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFEPIME IN PLASTIC CONTAINER~BAXTER
HLTHCARE~EQ 2GM BASE/100ML (EQ 20MG BASE/ML)~N~050817~002~~Aug 5, 2008~Yes~RX~B
CEFTIZOXIME SODIUM~INJECTABLE;INJECTION~CEFIZOX~ASTELLAS~EQ 1GM BASE/VIAL~A~0632
94~002~~Mar 31, 1994~No~DISCN~ASTELLAS PHARMA US INC
CEFTIZOXIME SODIUM~INJECTABLE;INJECTION~CEFIZOX~ASTELLAS~EQ 1GM BASE/VIAL~N~0505
60~002~~Sep 15, 1983~No~DISCN~ASTELLAS PHARMA US INC
CEFTIZOXIME SODIUM~INJECTABLE;INJECTION~CEFIZOX~ASTELLAS~EQ 2GM BASE/VIAL~A~0632
CEFTIZOXIME SODIUM~INJECTABLE;INJECTION~CEFIZOX~ASTELLAS~EQ 500MG BASE/VIAL~N~05
CEFTIZOXIME SODIUM~INJECTABLE;INJECTION~CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAI
NER~ASTELLAS~EQ 20MG BASE/ML~N~050589~001~~Oct 3, 1984~No~DISCN~ASTELLAS PHARMA
US INC
CEFTIZOXIME SODIUM~INJECTABLE;INJECTION~CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAI
NER~ASTELLAS~EQ 40MG BASE/ML~N~050589~002~~Oct 3, 1984~No~DISCN~ASTELLAS PHARMA
US INC
CEFTIZOXIME SODIUM~INJECTABLE;INJECTION~CEFIZOX IN PLASTIC CONTAINER~ASTELLAS~EQ
20MG BASE/ML~N~050589~003~~Apr 13, 1995~No~DISCN~ASTELLAS PHARMA US INC
CEFTIZOXIME SODIUM~INJECTABLE;INJECTION~CEFIZOX IN PLASTIC CONTAINER~ASTELLAS~EQ
40MG BASE/ML~N~050589~004~~Apr 13, 1995~No~DISCN~ASTELLAS PHARMA US INC
CEFMENOXIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFMAX~TAP PHARM~EQ 1GM BASE/VIAL
~N~050571~002~~Dec 30, 1987~No~DISCN~TAP PHARMACEUTICAL PRODUCTS INC
CEFMENOXIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFMAX~TAP PHARM~EQ 2GM BASE/VIAL
~N~050571~003~~Dec 30, 1987~No~DISCN~TAP PHARMACEUTICAL PRODUCTS INC
CEFMENOXIME HYDROCHLORIDE~INJECTABLE;INJECTION~CEFMAX~TAP PHARM~EQ 500MG BASE/VI
AL~N~050571~001~~Dec 30, 1987~No~DISCN~TAP PHARMACEUTICAL PRODUCTS INC
CEFOPERAZONE SODIUM~INJECTABLE;INJECTION~CEFOBID~PFIZER~EQ 1GM BASE/VIAL~A~06333
3~001~~Mar 31, 1995~No~DISCN~PFIZER INC
CEFOPERAZONE SODIUM~INJECTABLE;INJECTION~CEFOBID~PFIZER~EQ 1GM BASE/VIAL~N~05055
1~001~~Nov 18, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
CEFOPERAZONE SODIUM~INJECTABLE;INJECTION~CEFOBID~PFIZER~EQ 2GM BASE/VIAL~A~06333
3~002~~Mar 31, 1995~No~DISCN~PFIZER INC
1~002~~Nov 18, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
51~003~~Mar 5, 1990~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
CEFOPERAZONE SODIUM~INJECTABLE;INJECTION~CEFOBID IN PLASTIC CONTAINER~PFIZER~EQ
20MG BASE/ML~N~050613~002~~Jul 31, 1987~No~DISCN~PFIZER LABORATORIES DIV PFIZER
INC
CEFOPERAZONE SODIUM~INJECTABLE;INJECTION~CEFOBID IN PLASTIC CONTAINER~PFIZER~EQ
40MG BASE/ML~N~050613~001~~Jul 23, 1986~No~DISCN~PFIZER LABORATORIES DIV PFIZER
INC
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTAN~ASTRAZENECA~EQ 1GM BASE/VIAL~A~0
63293~001~~Apr 29, 1993~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP

CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTAN~ASTRAZENECA~EQ 1GM BASE/VIAL~N~0
50588~001~~Dec 27, 1985~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTAN~ASTRAZENECA~EQ 2GM BASE/VIAL~A~0
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTAN~ASTRAZENECA~EQ 2GM BASE/VIAL~N~0
50588~002~~Dec 27, 1985~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTAN~ASTRAZENECA~EQ 10GM BASE/VIAL~N~
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTAN IN PLASTIC CONTAINER~ASTRAZENECA
~EQ 20MG BASE/ML~N~050694~002~~Jul 30, 1993~No~DISCN~ASTRAZENECA PHARMACEUTICALS
LP
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTAN IN PLASTIC CONTAINER~ASTRAZENECA
~EQ 40MG BASE/ML~N~050694~001~~Jul 30, 1993~No~DISCN~ASTRAZENECA PHARMACEUTICALS
LP
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME~FRESENIUS KABI USA~EQ 1GM BASE
/VIAL~A~064200~002~~Mar 24, 2000~No~DISCN~FRESENIUS KABI USA LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME~FRESENIUS KABI USA~EQ 2GM BASE
/VIAL~A~064200~003~~Mar 24, 2000~No~DISCN~FRESENIUS KABI USA LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME~FRESENIUS KABI USA~EQ 10GM BAS
E/VIAL~A~064201~001~~Mar 24, 2000~No~DISCN~FRESENIUS KABI USA LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME~FRESENIUS KABI USA~EQ 20GM BAS
E/VIAL~A~064201~002~~Mar 24, 2000~No~DISCN~FRESENIUS KABI USA LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME~FRESENIUS KABI USA~EQ 500MG BA
SE/VIAL~A~064200~001~~Mar 24, 2000~No~DISCN~FRESENIUS KABI USA LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME~HIKMA~EQ 1GM BASE/VIAL~A~06507
2~002~AP~Nov 20, 2002~No~RX~HIKMA FARMACEUTICA LDA
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME~HIKMA~EQ 500MG BASE/VIAL~A~065
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME~WOCKHARDT~EQ 1GM BASE/VIAL~A~0
65197~001~AP~Aug 29, 2006~No~RX~WOCKHARDT LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC C
ONTAINER~B BRAUN~EQ 2GM BASE~N~050792~001~~Jul 29, 2004~No~DISCN~B BRAUN MEDICAL
INC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC C
ONTAINER~B BRAUN~EQ 1GM BASE~N~050792~002~~Jul 29, 2004~No~DISCN~B BRAUN MEDICAL
INC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~AUROBINDO PHARMA~EQ 1GM
BASE/VIAL~A~065517~002~~Nov 6, 2009~No~DISCN~AUROBINDO PHARMA LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~AUROBINDO PHARMA~EQ 2GM
BASE/VIAL~A~065517~003~~Nov 6, 2009~No~DISCN~AUROBINDO PHARMA LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~AUROBINDO PHARMA~EQ 500
MG BASE/VIAL~A~065517~001~~Nov 6, 2009~No~DISCN~AUROBINDO PHARMA LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~AUROBINDO PHARMA LTD~EQ
10GM BASE/VIAL~A~065516~001~~Nov 6, 2009~No~DISCN~AUROBINDO PHARMA LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~CEPHAZONE PHARMA~EQ 10G
M BASE/VIAL~A~065348~001~~Jan 25, 2010~No~DISCN~CEPHAZONE PHARMA LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~HOSPIRA INC~EQ 1GM BASE
/VIAL~A~065290~002~AP~Aug 11, 2006~No~RX~HOSPIRA INC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~HOSPIRA INC~EQ 10GM BAS
E/VIAL~A~065292~001~AP~Aug 10, 2006~No~RX~HOSPIRA INC

CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~HOSPIRA INC~EQ 500MG BA
SE/VIAL~A~065290~001~AP~Aug 11, 2006~No~RX~HOSPIRA INC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~LUPIN~EQ 1GM BASE/VIAL~
A~065124~002~AP~Sep 24, 2003~No~RX~LUPIN LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~LUPIN~EQ 2GM BASE/VIAL~
A~065124~003~AP~Sep 24, 2003~No~RX~LUPIN LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~LUPIN~EQ 500MG BASE/VIA
L~A~065124~001~AP~Sep 24, 2003~No~RX~LUPIN LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~WOCKHARDT~EQ 2GM BASE/V
IAL~A~065197~003~AP~Jun 20, 2008~No~RX~WOCKHARDT LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CEFOTAXIME SODIUM~WOCKHARDT~EQ 500MG BASE
/VIAL~A~065197~002~AP~Jun 20, 2008~No~RX~WOCKHARDT LTD
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTETAN~FRESENIUS KABI USA~EQ 1GM BASE
/VIAL~A~065374~001~AP~Aug 9, 2007~Yes~RX~FRESENIUS KABI USA LLC
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTETAN~FRESENIUS KABI USA~EQ 2GM BASE
/VIAL~A~065374~002~AP~Aug 9, 2007~Yes~RX~FRESENIUS KABI USA LLC
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTETAN~FRESENIUS KABI USA~EQ 10GM BAS
E/VIAL~A~065375~001~AP~Aug 9, 2007~Yes~RX~FRESENIUS KABI USA LLC
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTETAN~WEST-WARD PHARM CORP~EQ 1GM BA
SE/VIAL~A~091031~001~AP~Oct 26, 2011~No~RX~WEST-WARD PHARMACEUTICAL CORP
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTETAN~WEST-WARD PHARM CORP~EQ 2GM BA
SE/VIAL~A~091031~002~AP~Oct 26, 2011~No~RX~WEST-WARD PHARMACEUTICAL CORP
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTETAN~WEST-WARD PHARM CORP~EQ 10GM B
ASE/VIAL~A~091030~001~AP~Oct 26, 2011~No~RX~WEST-WARD PHARMACEUTICAL CORP
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTETAN AND DEXTROSE IN DUPLEX CONTAIN
ER~B BRAUN~EQ 1GM BASE/VIAL~A~065430~001~~Aug 9, 2007~Yes~RX~B BRAUN MEDICAL INC
CEFOTETAN DISODIUM~INJECTABLE;INJECTION~CEFOTETAN AND DEXTROSE IN DUPLEX CONTAIN
ER~B BRAUN~EQ 2GM BASE/VIAL~A~065430~002~~Aug 9, 2007~Yes~RX~B BRAUN MEDICAL INC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~ACS DOBFAR~EQ 1GM BASE/VIAL~A~06
5414~001~AP~Jun 12, 2009~Yes~RX~ACS DOBFAR SPA
5414~002~AP~Jun 12, 2009~Yes~RX~ACS DOBFAR SPA
65415~001~AP~May 19, 2010~Yes~RX~ACS DOBFAR SPA
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~ANTIBIOTICOS BRASIL~EQ 1GM BASE/
VIAL~A~065467~001~AP~Aug 31, 2011~No~RX~ANTIBIOTICOS DO BRASIL LTDA
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~ANTIBIOTICOS BRASIL~EQ 2GM BASE/
VIAL~A~065467~002~AP~Aug 31, 2011~No~RX~ANTIBIOTICOS DO BRASIL LTDA
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~ANTIBIOTICOS BRASIL~EQ 10GM BASE
/VIAL~A~065464~001~AP~Aug 31, 2011~No~RX~ANTIBIOTICOS DO BRASIL LTDA
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~FRESENIUS KABI USA~EQ 1GM BASE/V
IAL~A~065012~001~~Jul 3, 2000~No~DISCN~FRESENIUS KABI USA LLC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~FRESENIUS KABI USA~EQ 2GM BASE/V
IAL~A~065012~002~~Jul 3, 2000~No~DISCN~FRESENIUS KABI USA LLC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~FRESENIUS KABI USA~EQ 10GM BASE/
VIAL~A~065011~001~~Jul 3, 2000~No~DISCN~FRESENIUS KABI USA LLC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HIKMA FARMACEUTICA~EQ 1GM BASE/V
IAL~A~065238~001~AP~Mar 12, 2010~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HIKMA FARMACEUTICA~EQ 2GM BASE/V
IAL~A~065238~002~AP~Mar 12, 2010~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HIKMA FARMACEUTICA~EQ 10GM BASE/
VIAL~A~065239~001~AP~Mar 2, 2010~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HIKMA MAPLE ~EQ 1GM BASE/VIAL~A~
065051~001~AP~Sep 11, 2000~No~RX~HIKMA MAPLE LTD
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HIKMA MAPLE ~EQ 2GM BASE/VIAL~A~
065051~002~AP~Sep 11, 2000~No~RX~HIKMA MAPLE LTD
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HIKMA MAPLE ~EQ 10GM BASE/VIAL~A
~065050~001~AP~Sep 11, 2000~No~RX~HIKMA MAPLE LTD
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HOSPIRA INC~EQ 1GM BASE/VIAL~A~0
65313~001~AP~Jan 23, 2006~No~RX~HOSPIRA INC

CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HOSPIRA INC~EQ 2GM BASE/VIAL~A~0
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN~HOSPIRA INC~EQ 10GM BASE/VIAL~A~
065312~001~AP~Feb 13, 2006~No~RX~HOSPIRA INC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
~B BRAUN~EQ 1GM BASE/VIAL~A~065214~001~AP~Mar 10, 2006~No~RX~B BRAUN MEDICAL INC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
~B BRAUN~EQ 2GM BASE/VIAL~A~065214~002~AP~Mar 10, 2006~No~RX~B BRAUN MEDICAL INC
CEFPIRAMIDE SODIUM~INJECTABLE;INJECTION~CEFPIRAMIDE SODIUM~WYETH AYERST~EQ 1GM B
ASE/VIAL~N~050633~002~~Jan 31, 1989~No~DISCN~WYETH AYERST LABORATORIES
CEFPIRAMIDE SODIUM~INJECTABLE;INJECTION~CEFPIRAMIDE SODIUM~WYETH AYERST~EQ 2GM B
ASE/VIAL~N~050633~003~~Jan 31, 1989~No~DISCN~WYETH AYERST LABORATORIES
CEFPIRAMIDE SODIUM~INJECTABLE;INJECTION~CEFPIRAMIDE SODIUM~WYETH AYERST~EQ 10GM
BASE/VIAL~N~050633~005~~Jan 31, 1989~No~DISCN~WYETH AYERST LABORATORIES
CEFTAZIDIME~INJECTABLE;INJECTION~CEFTAZIDIME~ACS DOBFAR~1GM/VIAL~A~062640~002~AP
~Nov 20, 1985~No~RX~ACS DOBFAR SPA
~Nov 20, 1985~No~RX~ACS DOBFAR SPA
~Feb 3, 1992~No~RX~ACS DOBFAR SPA
CEFTAZIDIME~INJECTABLE;INJECTION~CEFTAZIDIME~ACS DOBFAR~500MG/VIAL~A~062640~001~
AP~Nov 20, 1985~No~RX~ACS DOBFAR SPA
CEFTAZIDIME~INJECTABLE;INJECTION~CEFTAZIDIME~AUROBINDO PHARMA LTD~1GM/VIAL~A~065
481~002~~May 28, 2010~No~DISCN~AUROBINDO PHARMA LTD
CEFTAZIDIME~INJECTABLE;INJECTION~CEFTAZIDIME~AUROBINDO PHARMA LTD~500MG/VIAL~A~0
CEFTAZIDIME~INJECTABLE;INJECTION~CEFTAZIDIME~WOCKHARDT~1GM/VIAL~A~065196~001~AP~
Oct 15, 2008~No~RX~WOCKHARDT LTD
CEFTAZIDIME~INJECTABLE;INJECTION~CEFTAZIDIME IN DEXTROSE CONTAINER~B BRAUN~EQ 1G
M BASE~N~050823~001~~Jun 13, 2011~No~RX~B BRAUN MEDICAL INC
CEFTAZIDIME~INJECTABLE;INJECTION~CEFTAZIDIME IN DEXTROSE CONTAINER~B BRAUN~EQ 2G
M BASE~N~050823~002~~Jun 13, 2011~Yes~RX~B BRAUN MEDICAL INC
CEFTAZIDIME SODIUM~INJECTABLE;INJECTION~CEFTAZIDIME SODIUM IN PLASTIC CONTAINER~
BAXTER HLTHCARE~EQ 10MG BASE/ML~A~063221~001~~Apr 29, 1993~No~DISCN~BAXTER HEALT
HCARE CORP
HCARE CORP
HCARE CORP
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~ACS DOBFAR~EQ 1GM BASE/VIAL~
A~065329~002~AP~Jul 24, 2008~No~RX~ACS DOBFAR SPA
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~ACS DOBFAR~EQ 2GM BASE/VIAL~
A~065329~003~AP~Jul 24, 2008~No~RX~ACS DOBFAR SPA
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~ACS DOBFAR~EQ 10GM BASE/VIAL
~A~065328~001~AP~Jul 24, 2008~No~RX~ACS DOBFAR SPA
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~ACS DOBFAR~EQ 500MG BASE/VIA
L~A~065329~001~AP~Jul 24, 2008~No~RX~ACS DOBFAR SPA
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~AGILA SPECLTS~EQ 10GM BASE/V
IAL~A~091068~001~~Jan 7, 2013~No~DISCN~AGILA SPECIALTIES PRIVATE LTD
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~AUROBINDO PHARMA LTD~EQ 10GM
BASE/VIAL~A~065504~001~~Jul 31, 2008~No~DISCN~AUROBINDO PHARMA LTD
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~BEDFORD~EQ 10GM BASE/VIAL~A~
065475~001~AP~Aug 18, 2008~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES
INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~FACTA FARMA~EQ 10GM BASE/VIA
L~A~065269~001~AP~Feb 28, 2007~No~RX~FACTA FARMACEUTICI SPA
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~FRESENIUS KABI USA~EQ 10GM B
ASE/VIAL~A~065252~001~~Feb 15, 2006~No~DISCN~FRESENIUS KABI USA LLC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~HOSPIRA INC~EQ 1GM BASE/VIAL
~A~065231~001~AP~Aug 2, 2005~No~RX~HOSPIRA INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~HOSPIRA INC~EQ 10GM BASE/VIA
L~A~065232~001~AP~Aug 2, 2005~No~RX~HOSPIRA INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~LUPIN~EQ 10GM BASE/VIAL~A~06
5263~001~AP~Sep 12, 2006~No~RX~LUPIN LTD
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~SAMSON MEDCL~EQ 100GM BASE/V
IAL~A~090057~001~~Apr 25, 2014~No~RX~SAMSON MEDICAL TECHNOLOGIES LLC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~SANDOZ~EQ 10GM BASE/VIAL~A~0
65168~001~AP~May 17, 2005~Yes~RX~SANDOZ INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~SANDOZ INC~EQ 1GM BASE/VIAL~
A~065204~001~AP~May 3, 2005~Yes~RX~SANDOZ INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~SANDOZ INC~EQ 2GM BASE/VIAL~
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~TEVA~EQ 10GM BASE/VIAL~A~065
274~001~~May 1, 2006~No~DISCN~TEVA PHARMACEUTICALS USA INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE~WOCKHARDT~EQ 1GM BASE/VIAL~A
~065180~001~AP~May 12, 2006~No~RX~WOCKHARDT LTD
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTA
INER~B BRAUN~EQ 1GM BASE/VIAL~N~050796~001~AP~Apr 20, 2005~Yes~RX~B BRAUN MEDICA
L INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTA
INER~B BRAUN~EQ 2GM BASE/VIAL~N~050796~002~AP~Apr 20, 2005~Yes~RX~B BRAUN MEDICA
L INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE IN PLASTIC CONTAINER~BAXTER
HLTHCARE~EQ 20MG BASE/ML~A~065224~001~~Aug 23, 2005~Yes~RX~BAXTER HEALTHCARE COR
P
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~CEFTRIAXONE IN PLASTIC CONTAINER~BAXTER
HLTHCARE~EQ 40MG BASE/ML~A~065224~002~~Aug 23, 2005~Yes~RX~BAXTER HEALTHCARE COR
P
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME AND DEXTROSE IN DUPLEX CONTAIN
ER~B BRAUN~EQ 1.5GM BASE/VIAL~N~050780~002~AP~Feb 21, 2001~Yes~RX~B BRAUN MEDICA
L INC
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME AND DEXTROSE IN DUPLEX CONTAIN
ER~B BRAUN~EQ 750MG BASE/VIAL~N~050780~001~AP~Feb 21, 2001~Yes~RX~B BRAUN MEDICA
L INC
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~FACTA FARMA~EQ 1.5GM BA
SE/VIAL~A~064125~002~AP~May 30, 1997~No~RX~FACTA FARMACEUTICI SPA
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~FACTA FARMA~EQ 7.5GM BA
SE/VIAL~A~064124~001~AP~May 30, 1997~No~RX~FACTA FARMACEUTICI SPA
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~FRESENIUS KABI USA~EQ 1
.5GM BASE/VIAL~A~065001~002~~May 30, 2001~No~DISCN~FRESENIUS KABI USA LLC
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~FRESENIUS KABI USA~EQ 7
.5GM BASE/VIAL~A~065002~001~~Sep 28, 1998~No~DISCN~FRESENIUS KABI USA LLC
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~HIKMA FARMACEUTICA~EQ 1
.5GM BASE/VIAL~A~065048~002~AP~Jan 9, 2004~No~RX~HIKMA FARMACEUTICA PORTUGAL LDA
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~HIKMA FARMACEUTICA~EQ 7
.5GM BASE/VIAL~A~065046~001~AP~Jan 9, 2004~No~RX~HIKMA FARMACEUTICA PORTUGAL LDA
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~HOSPIRA INC~EQ 1.5GM BA
SE/VIAL~A~065483~002~AP~Oct 15, 2008~No~RX~HOSPIRA INC

CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~TEVA PHARMS~EQ 7.5GM BA
SE/VIAL~A~064191~001~~Apr 16, 1998~No~DISCN~TEVA PHARMACEUTICALS USA
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~WATSON LABS INC~EQ 1.5G
M BASE/VIAL~A~064035~002~~Feb 26, 1993~No~DISCN~WATSON LABORATORIES INC
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM~WATSON LABS INC~EQ 7.5G
M BASE/VIAL~A~064036~001~~Feb 26, 1993~No~DISCN~WATSON LABORATORIES INC
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM IN PLASTIC CONTAINER~SA
MSON MEDCL~EQ 75GM BASE/VIAL~A~065251~001~~Dec 30, 2009~No~DISCN~SAMSON MEDICAL
TECHNOLOGIES LLC
CEFUROXIME SODIUM~INJECTABLE;INJECTION~CEFUROXIME SODIUM IN PLASTIC CONTAINER~SA
MSON MEDCL~EQ 225GM BASE/VIAL~A~065251~002~~Dec 30, 2009~No~DISCN~SAMSON MEDICAL
TECHNOLOGIES LLC
BETAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~CELESTONE~SCHERING~EQ 3MG BA
SE/ML **Federal Register determination that product was not discontinued or with
drawn for safety or efficacy reasons**~N~017561~001~~Approved Prior to Jan 1, 19
82~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~CELES
TONE SOLUSPAN~MERCK SHARP DOHME~3MG/ML;EQ 3MG BASE/ML~N~014602~001~AB~Approved P
rior to Jan 1, 1982~Yes~RX~MERCK SHARP AND DOHME CORP
MYCOPHENOLATE MOFETIL HYDROCHLORIDE~INJECTABLE;INJECTION~CELLCEPT~ROCHE PALO~500
MG/VIAL~N~050758~001~~Aug 12, 1998~Yes~RX~ROCHE PALO ALTO LLC
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN~INTL MEDICATION~EQ 1GM BASE/
VIAL~A~062426~002~~May 3, 1985~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN~INTL MEDICATION~EQ 500MG BAS
E/VIAL~A~062426~001~~May 3, 1985~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN SODIUM~ABBOTT~EQ 1GM BASE/VI
AL~A~062547~001~~Sep 11, 1985~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUC
TS DIV
TS DIV
TS DIV
TS DIV
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN SODIUM~ABRAXIS PHARM~EQ 1GM
BASE/VIAL~A~062666~002~~Jun 10, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN SODIUM~ABRAXIS PHARM~EQ 2GM
BASE/VIAL~A~062666~001~~Jun 10, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN SODIUM~BRISTOL~EQ 1GM BASE/V
IAL~A~062464~001~~May 7, 1984~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL MYER
S CO
S CO
S CO
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTI
C CONTAINER~BAXTER HLTHCARE~EQ 20MG BASE/ML~A~062422~003~~Jan 31, 1984~No~DISCN~

BAXTER HEALTHCARE CORP
C CONTAINER~BAXTER HLTHCARE~EQ 20MG BASE/ML~A~062422~005~~Jul 16, 1991~No~DISCN~
C CONTAINER~BAXTER HLTHCARE~EQ 20MG BASE/ML~A~062730~001~~Mar 5, 1987~No~DISCN~B
C CONTAINER~BAXTER HLTHCARE~EQ 40MG BASE/ML~A~062422~004~~Jan 31, 1984~No~DISCN~
C CONTAINER~BAXTER HLTHCARE~EQ 40MG BASE/ML~A~062422~006~~Jul 16, 1991~No~DISCN~
C CONTAINER~BAXTER HLTHCARE~EQ 40MG BASE/ML~A~062730~002~~Mar 5, 1987~No~DISCN~B
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN
PLASTIC CONTAINER~BAXTER HLTHCARE~EQ 20MG BASE/ML~A~062422~001~~Jan 31, 1984~No
~DISCN~BAXTER HEALTHCARE CORP
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN
PLASTIC CONTAINER~BAXTER HLTHCARE~EQ 40MG BASE/ML~A~062422~002~~Jan 31, 1984~No
~DISCN~BAXTER HEALTHCARE CORP
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEPHAPIRIN SODIUM~ABRAXIS PHARM~EQ 1GM BA
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEPHAPIRIN SODIUM~ABRAXIS PHARM~EQ 20GM B
ASE/VIAL~A~062723~005~~Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEPHAPIRIN SODIUM~ABRAXIS PHARM~EQ 500MG
BASE/VIAL~A~062723~001~~Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEPHAPIRIN SODIUM~HIKMA MAPLE ~EQ 1GM BAS
E/VIAL~A~062720~002~~Jul 2, 1987~No~DISCN~HIKMA MAPLE LTD
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEPHAPIRIN SODIUM~HIKMA MAPLE ~EQ 2GM BAS
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEPHAPIRIN SODIUM~HIKMA MAPLE ~EQ 20GM BA
SE/VIAL~A~062720~004~~Jul 2, 1987~No~DISCN~HIKMA MAPLE LTD
CEPHAPIRIN SODIUM~INJECTABLE;INJECTION~CEPHAPIRIN SODIUM~HIKMA MAPLE ~EQ 500MG B
ASE/VIAL~A~062720~001~~Jul 2, 1987~No~DISCN~HIKMA MAPLE LTD
CEFTAZIDIME~INJECTABLE;INJECTION~CEPTAZ~GLAXOSMITHKLINE~1GM/VIAL~N~050646~002~~S
ep 27, 1990~No~DISCN~GLAXOSMITHKLINE
CEFTAZIDIME~INJECTABLE;INJECTION~CEPTAZ~GLAXOSMITHKLINE~2GM/VIAL~N~050646~003~~S
ep 27, 1990~No~DISCN~GLAXOSMITHKLINE
CEFTAZIDIME~INJECTABLE;INJECTION~CEPTAZ~GLAXOSMITHKLINE~10GM/VIAL~N~050646~004~~
Sep 27, 1990~No~DISCN~GLAXOSMITHKLINE
CEFTAZIDIME~INJECTABLE;INJECTION~CEPTAZ~GLAXOSMITHKLINE~500MG/VIAL~N~050646~001~
~Sep 27, 1990~No~DISCN~GLAXOSMITHKLINE
CEFOTIAM HYDROCHLORIDE~INJECTABLE;INJECTION~CERADON~TAKEDA~EQ 1GM BASE/VIAL~N~05
0601~001~~Dec 30, 1988~No~DISCN~TAKEDA CHEMICAL INDUSTRIES LTD
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~CEREBYX~PARKE DAVIS~EQ 50MG PHENYTOIN N
A/ML~N~020450~001~AP~Aug 5, 1996~No~RX~PARKE DAVIS DIV WARNER LAMBERT CO
ALGLUCERASE~INJECTABLE;INJECTION~CEREDASE~GENZYME~10 UNITS/ML~N~020057~004~~May
8, 1992~No~DISCN~GENZYME CORPORATION
ALGLUCERASE~INJECTABLE;INJECTION~CEREDASE~GENZYME~80 UNITS/ML~N~020057~003~~Apr
5, 1991~No~DISCN~GENZYME CORPORATION
TECHNETIUM TC-99M EXAMETAZIME KIT~INJECTABLE;INJECTION~CERETEC~GE HEALTHCARE~N/A
~N~019829~001~~Dec 30, 1988~Yes~RX~GE HEALTHCARE
IMIGLUCERASE~INJECTABLE;INJECTION~CEREZYME~GENZYME~200 UNITS/VIAL~N~020367~001~~
May 23, 1994~No~RX~GENZYME CORP

IMIGLUCERASE~INJECTABLE;INJECTION~CEREZYME~GENZYME~400 UNITS/VIAL~N~020367~002~~
Sep 22, 1999~Yes~RX~GENZYME CORP
DAUNORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~CERUBIDINE~EUROHLTH INTL SARL~EQ
20MG BASE/VIAL~A~064103~001~AP~Feb 3, 1995~Yes~RX~EUROHEALTH INTERNATIONAL SARL
DAUNORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~CERUBIDINE~SANOFI AVENTIS US~EQ
20MG BASE/VIAL~A~061876~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENT
IS US LLC
DAUNORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~CERUBIDINE~WYETH AYERST~EQ 20MG
BASE/VIAL~N~050484~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST RESE
ARCH
CETRORELIX~INJECTABLE;INJECTION~CETROTIDE~EMD SERONO INC~EQ 0.25MG BASE/ML~N~021
197~001~~Aug 11, 2000~Yes~RX~EMD SERONO INC
CETRORELIX~INJECTABLE;INJECTION~CETROTIDE~EMD SERONO INC~EQ 3MG BASE/ML~N~021197
~002~~Aug 11, 2000~No~DISCN~EMD SERONO INC
LEVOBUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHIROCAINE~PURDUE PHARMA LP~E
Q 2.5MG BASE/ML~N~020997~001~~Aug 5, 1999~No~DISCN~PURDUE PHARMA LP
Q 5MG BASE/ML~N~020997~002~~Aug 5, 1999~No~DISCN~PURDUE PHARMA LP
Q 7.5MG BASE/ML~N~020997~003~~Aug 5, 1999~No~DISCN~PURDUE PHARMA LP
CHLORPHENIRAMINE MALEATE~INJECTABLE;INJECTION~CHLOR-TRIMETON~SCHERING PLOUGH~10M
G/ML~N~008826~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING PLOUGH HEALTH
CARE PRODUCTS INC
CHLORPHENIRAMINE MALEATE~INJECTABLE;INJECTION~CHLOR-TRIMETON~SCHERING PLOUGH~100
MG/ML~N~008794~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING PLOUGH HEALT
HCARE PRODUCTS INC
CHLORAMPHENICOL SODIUM SUCCINATE~INJECTABLE;INJECTION~CHLORAMPHENICOL~ELKINS SIN
N~EQ 1GM BASE/VIAL~A~062406~001~~Nov 9, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS
CO INC
CHLORAMPHENICOL SODIUM SUCCINATE~INJECTABLE;INJECTION~CHLORAMPHENICOL SODIUM SUC
CINATE~FRESENIUS KABI USA~EQ 1GM BASE/VIAL~A~062365~001~~Aug 25, 1982~Yes~RX~FRE
SENIUS KABI USA LLC
CHLORAMPHENICOL SODIUM SUCCINATE~INJECTABLE;INJECTION~CHLORAMPHENICOL SODIUM SUC
CINATE~GRUPPO LEPETIT~EQ 1GM BASE/VIAL~A~062278~001~~Approved Prior to Jan 1, 19
82~No~DISCN~GRUPPO LEPETIT SPA SUB MERRELL DOW PHARMACEUTICALS INC
CHLORMERODRIN HG-197~INJECTABLE;INJECTION~CHLORMERODRIN HG 197~BRACCO~0.6-1.4mCi
/ML~N~017269~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
CHLORAMPHENICOL~INJECTABLE;INJECTION~CHLOROMYCETIN~PARKE DAVIS~250MG/ML~N~050153
~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS PHARMACEUTICAL RESEARCH
CHLORAMPHENICOL SODIUM SUCCINATE~INJECTABLE;INJECTION~CHLOROMYCETIN~PARKEDALE~EQ
1GM BASE/VIAL~N~050155~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PH
ARMACEUTICALS INC
CHLOROPROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHLOROPROCAINE HYDROCHLORIDE~E
UROHLTH INTL SARL~2%~A~040273~001~AP~Sep 9, 1998~No~RX~EUROHEALTH INTERNATIONAL
SARL
CHLOROPROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHLOROPROCAINE HYDROCHLORIDE~E
UROHLTH INTL SARL~3%~A~040273~002~AP~Sep 9, 1998~No~RX~EUROHEALTH INTERNATIONAL
SARL
CHLOROPROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHLOROPROCAINE HYDROCHLORIDE~H
OSPIRA~2%~A~087447~001~AP~Apr 16, 1982~No~RX~HOSPIRA INC
CHLOROPROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHLOROPROCAINE HYDROCHLORIDE~H
OSPIRA~3%~A~087446~001~AP~Apr 16, 1982~No~RX~HOSPIRA INC
CHLOROTHIAZIDE SODIUM~INJECTABLE;INJECTION~CHLOROTHIAZIDE SODIUM~FRESENIUS KABI
USA~EQ 500MG BASE/VIAL~A~090896~001~AP~Oct 16, 2009~No~RX~FRESENIUS KABI USA LLC
CHLOROTHIAZIDE SODIUM~INJECTABLE;INJECTION~CHLOROTHIAZIDE SODIUM~LUITPOLD~EQ 500
MG BASE/VIAL~A~202561~001~AP~Apr 22, 2013~No~RX~LUITPOLD PHARMACEUTICALS INC
CHLOROTHIAZIDE SODIUM~INJECTABLE;INJECTION~CHLOROTHIAZIDE SODIUM~MYLAN INSTITUTI
ONAL~EQ 500MG BASE/VIAL~A~202493~001~AP~Jun 18, 2014~No~RX~MYLAN INSTITUTIONAL L
LC
CHLOROTHIAZIDE SODIUM~INJECTABLE;INJECTION~CHLOROTHIAZIDE SODIUM~SUN PHARMA GLOB
AL~EQ 500MG BASE/VIAL~A~091546~001~AP~Jul 26, 2011~No~RX~SUN PHARMA GLOBAL FZE
CHLORPHENIRAMINE MALEATE~INJECTABLE;INJECTION~CHLORPHENIRAMINE MALEATE~BEL MAR~1
0MG/ML~A~080821~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES
INC
CHLORPHENIRAMINE MALEATE~INJECTABLE;INJECTION~CHLORPHENIRAMINE MALEATE~ELKINS SI
NN~10MG/ML~A~080797~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV
AH ROBINS CO INC
CHLORPHENIRAMINE MALEATE~INJECTABLE;INJECTION~CHLORPHENIRAMINE MALEATE~WATSON LA
BS~10MG/ML~A~083593~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATOR
IES INC
BS~10MG/ML~A~086096~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATOR
IES INC
BS~100MG/ML~A~086095~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATO
RIES INC
CHLORPROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHLORPROMAZINE HYDROCHLORIDE~A
BRAXIS PHARM~25MG/ML~A~084911~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXI
S PHARMACEUTICAL PRODUCTS
CHLORPROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHLORPROMAZINE HYDROCHLORIDE~E
UROHLTH INTL SARL~25MG/ML~A~083329~001~~Approved Prior to Jan 1, 1982~Yes~RX~EUR
OHEALTH INTERNATIONAL SARL
CHLORPROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHLORPROMAZINE HYDROCHLORIDE~M
ARSAM PHARMS LLC~25MG/ML~A~089563~001~~Apr 15, 1988~No~DISCN~MARSAM PHARMACEUTIC
ALS LLC
CHLORPROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~CHLORPROMAZINE HYDROCHLORIDE~W
ATSON LABS~25MG/ML~A~080365~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON L
ABORATORIES INC
ATSON LABS~25MG/ML~A~085591~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON L
ABORATORIES INC
YETH AYERST~25MG/ML~A~080370~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH A
YERST LABORATORIES
TECHNETIUM TC-99M MEBROFENIN KIT~INJECTABLE;INJECTION~CHOLETEC~BRACCO~N/A~N~0189
63~001~AP~Jan 21, 1987~Yes~RX~BRACCO DIAGNOSTICS INC
IODIPAMIDE MEGLUMINE~INJECTABLE;INJECTION~CHOLOGRAFIN MEGLUMINE~BRACCO~10.3%~N~0
09321~007~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
IODIPAMIDE MEGLUMINE~INJECTABLE;INJECTION~CHOLOGRAFIN MEGLUMINE~BRACCO~52%~N~009
321~003~~Approved Prior to Jan 1, 1982~Yes~RX~BRACCO DIAGNOSTICS INC
IODIPAMIDE SODIUM~INJECTABLE;INJECTION~CHOLOGRAFIN SODIUM~BRACCO~20%~N~009321~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
IODOXAMATE MEGLUMINE~INJECTABLE;INJECTION~CHOLOVUE~BRACCO~9.9%~N~018077~001~~App
IODOXAMATE MEGLUMINE~INJECTABLE;INJECTION~CHOLOVUE~BRACCO~40.3%~N~018076~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~CHORIONIC GONADOTROPIN~BEL MAR~5,00
0 UNITS/VIAL~N~017054~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORA
TORIES INC
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~CHORIONIC GONADOTROPIN~BEL MAR~10,0
00 UNITS/VIAL~N~017054~002~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABOR
ATORIES INC
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~CHORIONIC GONADOTROPIN~FERRING~2,00
0 UNITS/VIAL~N~017016~009~~Dec 27, 1984~No~DISCN~FERRING PHARMACEUTICALS INC
0 UNITS/VIAL~N~017016~011~~Feb 16, 1990~No~DISCN~FERRING PHARMACEUTICALS INC
0 UNITS/VIAL~N~017016~006~~Approved Prior to Jan 1, 1982~No~DISCN~FERRING PHARMA
CEUTICALS INC
00 UNITS/VIAL~N~017016~007~AP~Approved Prior to Jan 1, 1982~Yes~RX~FERRING PHARM
ACEUTICALS INC
00 UNITS/VIAL~N~017016~010~~Feb 15, 1985~No~DISCN~FERRING PHARMACEUTICALS INC
00 UNITS/VIAL~N~017016~004~~Approved Prior to Jan 1, 1982~No~DISCN~FERRING PHARM
ACEUTICALS INC
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~CHORIONIC GONADOTROPIN~FRESENIUS KA
BI USA~5,000 UNITS/VIAL~N~017067~001~~Approved Prior to Jan 1, 1982~No~DISCN~FRE
SENIUS KABI USA LLC
BI USA~10,000 UNITS/VIAL~N~017067~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~FR
ESENIUS KABI USA LLC
BI USA~15,000 UNITS/VIAL~N~017067~004~~Approved Prior to Jan 1, 1982~No~DISCN~FR
BI USA~20,000 UNITS/VIAL~N~017067~003~~Approved Prior to Jan 1, 1982~No~DISCN~FR
ALBUMIN CHROMATED CR-51 SERUM~INJECTABLE;INJECTION~CHROMALBIN~ISO TEX~100uCi/VIA
L~N~017835~001~~Approved Prior to Jan 1, 1982~No~DISCN~ISO TEX DIAGNOSTICS INC
CHROMIC CHLORIDE~INJECTABLE;INJECTION~CHROMIC CHLORIDE~ABRAXIS PHARM~EQ 0.004MG
CHROMIUM/ML~N~019271~001~~May 5, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CHROMIC CHLORIDE~INJECTABLE;INJECTION~CHROMIC CHLORIDE IN PLASTIC CONTAINER~HOSP
IRA~EQ 0.004MG CHROMIUM/ML~N~018961~001~~Jun 26, 1986~Yes~RX~HOSPIRA INC
SODIUM CHROMATE CR-51~INJECTABLE;INJECTION~CHROMITOPE SODIUM~BRACCO~2mCi/VIAL~N~
SODIUM CHROMATE CR-51~INJECTABLE;INJECTION~CHROMITOPE SODIUM~BRACCO~200uCi/ML~N~
CHYMOPAPAIN~INJECTABLE;INJECTION~CHYMODIACTIN~CHART MEDCL~4,000 UNITS/VIAL~N~018
663~002~~Aug 21, 1984~No~DISCN~CHART MEDICAL INC
CHYMOPAPAIN~INJECTABLE;INJECTION~CHYMODIACTIN~CHART MEDCL~10,000 UNITS/VIAL **Fe
safety or efficacy reasons**~N~018663~001~~Nov 10, 1982~No~DISCN~CHART MEDICAL I
NC
CALCITONIN HUMAN~INJECTABLE;INJECTION~CIBACALCIN~NOVARTIS~0.5MG/VIAL~N~018470~00
1~~Oct 31, 1986~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
CIDOFOVIR~INJECTABLE;INJECTION~CIDOFOVIR~EMCURE PHARMS LTD~EQ 75MG BASE/ML~A~202
501~001~AP~Jul 26, 2012~No~RX~EMCURE PHARMACEUTICALS LTD
CIDOFOVIR~INJECTABLE;INJECTION~CIDOFOVIR~MYLAN INSTITUTIONAL~EQ 75MG BASE/ML~A~2
01276~001~AP~Jun 27, 2012~No~RX~MYLAN INSTITUTIONAL LLC
CIMETIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CIMETIDINE HYDROCHLORIDE~DAVA PHAR
MS INC~EQ 300MG BASE/2ML~A~074428~001~AP~Apr 25, 1996~No~RX~DAVA PHARMACEUTICALS
INC
CIMETIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CIMETIDINE HYDROCHLORIDE~HOSPIRA~E
Q 300MG BASE/2ML~A~074296~001~~Mar 28, 1997~No~DISCN~HOSPIRA INC
Q 300MG BASE/2ML~A~074344~001~~Jan 31, 1995~No~DISCN~HOSPIRA INC
Q 300MG BASE/2ML~A~074412~001~~Mar 28, 1997~No~DISCN~HOSPIRA INC
CIMETIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CIMETIDINE HYDROCHLORIDE~LUITPOLD~

EQ 300MG BASE/2ML~A~074353~001~~Dec 20, 1994~No~DISCN~LUITPOLD PHARMACEUTICALS I
NC
CIMETIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CIMETIDINE HYDROCHLORIDE~TEVA PARE
NTERAL~EQ 300MG BASE/2ML~A~074252~001~~Nov 26, 1997~No~DISCN~TEVA PARENTERAL MED
ICINES INC
CIMETIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CIMETIDINE HYDROCHLORIDE~VINTAGE P
HARMS LLC~EQ 300MG BASE/2ML~A~074005~001~~Aug 31, 1994~No~DISCN~VINTAGE PHARMACE
UTICALS LLC
CIMETIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CIMETIDINE HYDROCHLORIDE IN SODIUM
CHLORIDE 0.9% IN PLASTIC CONTAINER~HOSPIRA~EQ 6MG BASE/ML~A~074269~001~~Dec 27,
1994~No~DISCN~HOSPIRA WORLDWIDE, INC
CHLORIDE 0.9% IN PLASTIC CONTAINER~HOSPIRA~EQ 90MG BASE/100ML~A~074468~005~~Dec
CHLORIDE 0.9% IN PLASTIC CONTAINER~HOSPIRA~EQ 120MG BASE/100ML~A~074468~006~~De
c 29, 1994~No~DISCN~HOSPIRA INC
TECHNETIUM TC-99M ETIDRONATE KIT~INJECTABLE;INJECTION~CINTICHEM TECHNETIUM 99M H
EDSPA~GE HEALTHCARE~N/A~N~017653~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE
HEALTHCARE
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPRO~BAYER HLTHCARE~400MG/40ML (10MG/ML)~N~0
19847~001~AP~Dec 26, 1990~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPRO~BAYER HLTHCARE~200MG/20ML (10MG/ML)~N~0
19847~002~AP~Dec 26, 1990~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPRO~BAYER HLTHCARE~1200MG/120ML (10MG/ML)~N
~019847~003~~Dec 26, 1990~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER~BAY
ER HLTHCARE~200MG/100ML~N~019857~001~AP~Dec 26, 1990~Yes~RX~BAYER HEALTHCARE PHA
RMACEUTICALS INC
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER~BAY
ER HLTHCARE~400MG/200ML~N~019857~002~AP~Dec 26, 1990~Yes~RX~BAYER HEALTHCARE PHA
RMACEUTICALS INC
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONT
AINER~BAYER PHARMS~200MG/100ML~N~019858~001~~Dec 26, 1990~No~DISCN~BAYER PHARMAC
EUTICALS CORP
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~BEDFORD LABS~200MG/20ML (10MG/M
L)~A~076992~001~~Aug 28, 2006~No~DISCN~BEDFORD LABORATORIES
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~BEDFORD LABS~400MG/40ML (10MG/M
L)~A~076992~002~~Aug 28, 2006~No~DISCN~BEDFORD LABORATORIES
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~BEDFORD LABS~1200MG/120ML (10MG
/ML)~A~076993~001~~Aug 28, 2006~No~DISCN~BEDFORD LABORATORIES
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~CLARIS LIFESCIENCES~200MG/20ML
(10MG/ML)~A~078062~001~AP~Apr 29, 2008~No~RX~CLARIS LIFESCIENCES LTD
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~CLARIS LIFESCIENCES~400MG/40ML
(10MG/ML)~A~078062~002~AP~Apr 29, 2008~No~RX~CLARIS LIFESCIENCES LTD
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~FRESENIUS KABI USA~200MG/20ML (
10MG/ML)~A~076484~001~~Aug 28, 2006~No~DISCN~FRESENIUS KABI USA LLC
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~FRESENIUS KABI USA~400MG/40ML (

10MG/ML)~A~076484~002~~Aug 28, 2006~No~DISCN~FRESENIUS KABI USA LLC
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~HIKMA FARMACEUTICA~200MG/20ML (
10MG/ML)~A~076717~001~AP~Dec 22, 2009~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~HIKMA FARMACEUTICA~400MG/40ML (
10MG/ML)~A~076717~002~AP~Dec 22, 2009~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~HOSPIRA~200MG/20ML (10MG/ML)~A~
077245~001~AP~Aug 28, 2006~No~RX~HOSPIRA INC
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~HOSPIRA~400MG/40ML (10MG/ML)~A~
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~TEVA PHARMS USA~200MG/20ML (10M
G/ML)~A~077782~001~~Aug 28, 2006~No~DISCN~TEVA PHARMACEUTICALS USA
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN~TEVA PHARMS USA~400MG/40ML (10M
G/ML)~A~077782~002~~Aug 28, 2006~No~DISCN~TEVA PHARMACEUTICALS USA
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN IN DEXTROSE 5%~HIKMA FARMACEUTI
CA~200MG/100ML~A~076757~001~~Apr 21, 2008~No~DISCN~HIKMA FARMACEUTICA (PORTUGAL)
SA
CIPROFLOXACIN~INJECTABLE;INJECTION~CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTA
INER~ACS DOBFAR INFO SA~200MG/100ML~A~078252~001~AP~Mar 18, 2008~No~RX~ACS DOBFA
R INFO SA
INER~ACS DOBFAR INFO SA~400MG/200ML~A~078252~002~AP~Mar 18, 2008~No~RX~ACS DOBFA
R INFO SA
INER~BAXTER HLTHCARE~200MG/100ML~A~077888~001~~Mar 18, 2008~No~DISCN~BAXTER HEAL
THCARE CORP
INER~BAXTER HLTHCARE~400MG/200ML~A~077888~002~~Mar 18, 2008~No~DISCN~BAXTER HEAL
THCARE CORP
INER~BEDFORD~200MG/100ML~A~078114~001~~Mar 18, 2008~No~DISCN~BEDFORD LABORATORIE
S DIV BEN VENUE LABORATORIES INC
INER~BEDFORD~400MG/200ML~A~078114~002~~Mar 18, 2008~No~DISCN~BEDFORD LABORATORIE
S DIV BEN VENUE LABORATORIES INC
INER~CLARIS LIFESCIENCES~200MG/100ML~A~078024~001~AP~Mar 18, 2008~No~RX~CLARIS L
IFESCIENCES LTD
INER~CLARIS LIFESCIENCES~400MG/200ML~A~078024~002~AP~Mar 18, 2008~No~RX~CLARIS L
IFESCIENCES LTD
INER~HIKMA FARMACEUTICA~400MG/200ML~A~078431~001~AP~Nov 18, 2009~No~RX~HIKMA FAR
MACEUTICA (PORTUGAL) SA
INER~HOSPIRA~200MG/100ML~A~077753~001~AP~Mar 18, 2008~No~RX~HOSPIRA INC
INER~HOSPIRA~400MG/200ML~A~077753~002~AP~Mar 18, 2008~No~RX~HOSPIRA INC
INER~TEVA PHARMS~200MG/100ML~A~077138~001~~Mar 18, 2008~No~DISCN~TEVA PHARMACEUT
ICALS USA
INER~TEVA PHARMS~400MG/200ML~A~077138~002~~Mar 18, 2008~No~DISCN~TEVA PHARMACEUT
ICALS USA
TECHNETIUM TC-99M MEDRONATE KIT~INJECTABLE;INJECTION~CIS-MDP~PHARMALUCENCE~N/A~N
~018124~001~AP~Approved Prior to Jan 1, 1982~No~RX~PHARMALUCENCE INC
TECHNETIUM TC-99M PYROPHOSPHATE KIT~INJECTABLE;INJECTION~CIS-PYRO~PHARMALUCENCE~
N/A~N~019039~001~AP~Jun 30, 1987~No~RX~PHARMALUCENCE INC
CISATRACURIUM BESYLATE~INJECTABLE;INJECTION~CISATRACURIUM BESYLATE~FRESENIUS KAB
I USA~EQ 2MG BASE/ML~A~203183~001~AP~Feb 26, 2015~No~RX~FRESENIUS KABI USA LLC
CISATRACURIUM BESYLATE~INJECTABLE;INJECTION~CISATRACURIUM BESYLATE~SANDOZ INC~EQ

2MG BASE/ML~A~200159~001~AP~Feb 3, 2012~No~RX~SANDOZ INC
CISATRACURIUM BESYLATE~INJECTABLE;INJECTION~CISATRACURIUM BESYLATE PRESERVATIVE
FREE~FRESENIUS KABI USA~EQ 2MG BASE/ML~A~203182~001~AP~Feb 26, 2015~No~RX~FRESEN
IUS KABI USA LLC
FREE~FRESENIUS KABI USA~EQ 10MG BASE/ML~A~203182~002~AP~Feb 26, 2015~No~RX~FRESE
NIUS KABI USA LLC
FREE~SANDOZ INC~EQ 2MG BASE/ML~A~200154~001~AP~Feb 3, 2012~No~RX~SANDOZ INC
FREE~SANDOZ INC~EQ 10MG BASE/ML~A~200154~002~AP~Feb 3, 2012~No~RX~SANDOZ INC
CISPLATIN~INJECTABLE;INJECTION~CISPLATIN~BEDFORD~10MG/VIAL~A~074713~001~~Nov 14,
2000~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
CISPLATIN~INJECTABLE;INJECTION~CISPLATIN~BEDFORD~50MG/VIAL~A~074713~002~~Nov 14,
CISPLATIN~INJECTABLE;INJECTION~CISPLATIN~EUROHLTH INTL SARL~1MG/ML~A~075036~001~
AP~Nov 7, 2000~No~RX~EUROHEALTH INTERNATIONAL SARL
CISPLATIN~INJECTABLE;INJECTION~CISPLATIN~FRESENIUS KABI USA~1MG/ML~A~074735~001~
AP~Jul 16, 1999~Yes~RX~FRESENIUS KABI USA LLC
CISPLATIN~INJECTABLE;INJECTION~CISPLATIN~HQ SPCLT PHARMA~1MG/ML~N~018057~004~AP~
Nov 8, 1988~No~RX~HQ SPECIALTY PHARMA CORP
CISPLATIN~INJECTABLE;INJECTION~CISPLATIN~ONCO THERAPIES LTD~1MG/ML~A~091062~001~
AP~Apr 18, 2012~No~RX~ONCO THERAPIES LTD
CISPLATIN~INJECTABLE;INJECTION~CISPLATIN~PHARMACHEMIE BV~1MG/ML~A~074656~001~AP~
May 16, 2000~No~RX~PHARMACHEMIE BV
CISPLATIN~INJECTABLE;INJECTION~CISPLATIN~TEVA PHARMS USA~1MG/ML~A~074814~001~~Ma
y 16, 2000~No~DISCN~TEVA PHARMACEUTICALS USA
PRILOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CITANEST~ASTRAZENECA~1%~N~014763~0
04~~Approved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA LP
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CITANEST F
ORTE~ASTRAZENECA~0.005MG/ML;4%~N~014763~008~~Approved Prior to Jan 1, 1982~No~DI
SCN~ASTRAZENECA LP
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CITANEST F
ORTE DENTAL~DENTSPLY PHARM~0.005MG/ML;4%~N~021383~001~AP~Approved Prior to Jan 1
, 1982~Yes~RX~DENTSPLY PHARMACEUTICAL INC
PRILOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CITANEST PLAIN~ASTRAZENECA~4%~N~01
4763~007~~Approved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA LP
PRILOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~CITANEST PLAIN DENTAL~DENTSPLY PHA
RM~4%~N~021382~001~~Approved Prior to Jan 1, 1982~No~DISCN~DENTSPLY PHARMACEUTIC
AL INC
CLADRIBINE~INJECTABLE;INJECTION~CLADRIBINE~EUROHLTH INTL SARL~1MG/ML~A~075405~00
1~AP~Feb 28, 2000~No~RX~EUROHEALTH INTERNATIONAL SARL
CLADRIBINE~INJECTABLE;INJECTION~CLADRIBINE~FRESENIUS KABI USA~1MG/ML~A~076571~00
1~AP~Apr 22, 2004~Yes~RX~FRESENIUS KABI USA LLC
CLADRIBINE~INJECTABLE;INJECTION~CLADRIBINE~ONCO THERAPIES LTD~1MG/ML~A~200510~00
1~AP~Oct 6, 2011~No~RX~ONCO THERAPIES LTD
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CLAFORAN~SANOFI AVENTIS US~EQ 1GM BASE/VI
AL~A~062659~001~AP~Jan 13, 1987~Yes~RX~SANOFI AVENTIS US LLC
AL~N~050547~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
AL~A~062659~002~AP~Jan 13, 1987~Yes~RX~SANOFI AVENTIS US LLC
AL~N~050547~003~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CLAFORAN~SANOFI AVENTIS US~EQ 10GM BASE/V
IAL~N~050547~004~AP~Dec 29, 1983~Yes~RX~SANOFI AVENTIS US LLC

CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CLAFORAN~SANOFI AVENTIS US~EQ 500MG BASE/
VIAL~N~050547~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAI
NER~SANOFI AVENTIS US~EQ 20MG BASE/ML~N~050596~002~~May 20, 1985~Yes~RX~SANOFI A
VENTIS US LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAI
NER~SANOFI AVENTIS US~EQ 40MG BASE/ML~N~050596~004~~May 20, 1985~Yes~RX~SANOFI A
VENTIS US LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLAST
IC CONTAINER~SANOFI AVENTIS US~EQ 20MG BASE/ML~N~050596~001~~May 20, 1985~No~DIS
CN~SANOFI AVENTIS US LLC
CEFOTAXIME SODIUM~INJECTABLE;INJECTION~CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLAST
IC CONTAINER~SANOFI AVENTIS US~EQ 40MG BASE/ML~N~050596~003~~May 20, 1985~No~DIS
CN~SANOFI AVENTIS US LLC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLEOCIN PHOSPHATE~PHARMACIA AND UPJOH
N~EQ 150MG BASE/ML~A~061839~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACI
A AND UPJOHN CO
N~EQ 150MG BASE/ML~A~062803~001~AP~Oct 16, 1987~No~RX~PHARMACIA AND UPJOHN CO
N~EQ 150MG BASE/ML~N~050441~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACI
A AND UPJOHN CO
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLEOCIN PHOSPHATE IN DEXTROSE 5% IN P
LASTIC CONTAINER~PHARMACIA AND UPJOHN~EQ 6MG BASE/ML~N~050639~001~AP~Aug 30, 198
9~Yes~RX~PHARMACIA AND UPJOHN CO
LASTIC CONTAINER~PHARMACIA AND UPJOHN~EQ 12MG BASE/ML~N~050639~002~AP~Aug 30, 19
LASTIC CONTAINER~PHARMACIA AND UPJOHN~EQ 18MG BASE/ML~N~050639~003~AP~Apr 10, 19
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~ABRAXIS PHARM~E
Q 150MG BASE/ML~A~062747~001~~Jun 3, 1988~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUC
TS
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~ASTRAZENECA~EQ
150MG BASE/ML~A~062928~001~~Feb 13, 1989~No~DISCN~ASTRAZENECA LP
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~BEDFORD~EQ 150M
G BASE/ML~A~063163~001~~Jun 30, 1994~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE
LABORATORIES INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~BEDFORD~EQ 150M
G BASE/ML~A~065206~001~AP~Sep 24, 2004~No~RX~BEDFORD LABORATORIES DIV BEN VENUE
LABORATORIES INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~BRISTOL MYERS S
QUIBB~EQ 150MG BASE/ML~A~062908~001~~Feb 1, 1989~No~DISCN~BRISTOL MYERS SQUIBB P
HARMA CO
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~FRESENIUS KABI
USA~EQ 150MG BASE/ML~A~065346~001~AP~Mar 29, 2007~No~RX~FRESENIUS KABI USA LLC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~FRESENIUS KABI
USA~EQ 150MG BASE/ML~A~065347~001~AP~May 9, 2007~No~RX~FRESENIUS KABI USA LLC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~HIKMA MAPLE ~EQ
150MG BASE/ML~A~062806~001~~Oct 15, 1987~No~DISCN~HIKMA MAPLE LTD
150MG BASE/ML~A~062889~001~AP~Apr 25, 1988~No~RX~HIKMA MAPLE LTD
150MG BASE/ML~A~062953~001~~Apr 21, 1988~No~DISCN~HIKMA MAPLE LTD
150MG BASE/ML~A~063068~001~~Aug 28, 1989~No~DISCN~HIKMA MAPLE LTD
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~HOSPIRA~EQ 150M
G BASE/ML~A~062800~001~AP~Jul 24, 1987~No~RX~HOSPIRA INC

G BASE/ML~A~062801~001~AP~Jul 24, 1987~No~RX~HOSPIRA INC
G BASE/ML~A~062943~001~AP~Sep 29, 1988~No~RX~HOSPIRA INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~LOCH~EQ 150MG B
ASE/ML~A~062905~001~~May 9, 1988~No~DISCN~LOCH PHARMACEUTICALS INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~MARSAM PHARMS L
LC~EQ 150MG BASE/ML~A~062913~001~~Oct 20, 1988~No~DISCN~MARSAM PHARMACEUTICALS L
LC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~SAGENT PHARMS~E
Q 150MG BASE/ML~A~090108~001~AP~Sep 30, 2011~No~RX~SAGENT PHARMACEUTICALS INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~SAGENT STRIDES~
EQ 150MG BASE/ML~A~090109~001~AP~Sep 30, 2011~No~RX~SAGENT STRIDES LLC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~SOLOPAK~EQ 150M
G BASE/ML~A~062819~001~~Mar 15, 1988~No~DISCN~SOLOPAK LABORATORIES INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~SOLOPAK~EQ 150M
G BASE/ML~A~062852~001~~Mar 17, 1988~No~DISCN~SOLOPAK LABORATORIES INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~TEVA PARENTERAL
~EQ 150MG BASE/ML~A~063041~001~~Dec 29, 1989~No~DISCN~TEVA PARENTERAL MEDICINES
INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~TEVA PARENTERAL
~EQ 150MG BASE/ML~A~063282~001~~May 29, 1992~No~DISCN~TEVA PARENTERAL MEDICINES
INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~WATSON LABS~EQ
150MG BASE/ML~A~062900~001~~Jun 8, 1988~No~DISCN~WATSON LABORATORIES INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE~WATSON LABS~EQ
150MG BASE/ML~A~063079~001~~Mar 5, 1990~No~DISCN~WATSON LABORATORIES INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE
IN PLASTIC CONTAINER~AKORN INC~EQ 6MG BASE/ML~A~203048~001~AP~Apr 4, 2013~No~RX~
AKORN INC
IN PLASTIC CONTAINER~AKORN INC~EQ 12MG BASE/ML~A~203048~002~AP~Apr 4, 2013~No~RX
~AKORN INC
IN PLASTIC CONTAINER~AKORN INC~EQ 18MG BASE/ML~A~203048~003~AP~Apr 4, 2013~No~RX
~AKORN INC
IN PLASTIC CONTAINER~SANDOZ INC~EQ 6MG BASE/ML~A~201692~001~AP~May 31, 2012~No~R
X~SANDOZ INC
IN PLASTIC CONTAINER~SANDOZ INC~EQ 12MG BASE/ML~A~201692~002~AP~May 31, 2012~No~
RX~SANDOZ INC
IN PLASTIC CONTAINER~SANDOZ INC~EQ 18MG BASE/ML~A~201692~003~AP~May 31, 2012~No~
RX~SANDOZ INC
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%~
ABRAXIS PHARM~EQ 12MG BASE/ML~N~050636~001~~Dec 22, 1989~No~DISCN~ABRAXIS PHARMA
CEUTICAL PRODUCTS
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%~
ABRAXIS PHARM~EQ 900MG BASE/100ML~N~050635~001~~Dec 22, 1989~Yes~RX~ABRAXIS PHAR
MACEUTICAL PRODUCTS
CLINDAMYCIN PHOSPHATE~INJECTABLE;INJECTION~CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
IN PLASTIC CONTAINER~ABBVIE~EQ 6MG BASE/ML~A~065027~001~~Jun 29, 2001~No~DISCN~A
BBVIE INC
IN PLASTIC CONTAINER~ABBVIE~EQ 12MG BASE/ML~A~065027~002~~Jun 29, 2001~No~DISCN~
ABBVIE INC
IN PLASTIC CONTAINER~ABBVIE~EQ 18MG BASE/ML~A~065027~003~~Jun 29, 2001~No~DISCN~
ABBVIE INC

IN PLASTIC CONTAINER~BAXTER HLTHCARE~EQ 6MG BASE/ML~N~050648~001~~Dec 29, 1989~N
o~DISCN~BAXTER HEALTHCARE CORP
IN PLASTIC CONTAINER~BAXTER HLTHCARE~EQ 12MG BASE/ML~N~050648~002~~Dec 29, 1989~
No~DISCN~BAXTER HEALTHCARE CORP
IN PLASTIC CONTAINER~BAXTER HLTHCARE~EQ 900MG BASE/100ML~N~050648~003~~Dec 29, 1
989~No~DISCN~BAXTER HEALTHCARE CORP
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~CLINIMIX 2.75/10 SULFITE FREE IN DEXT
ROSE 10% IN PLASTIC CONTAINER~BAXTER HLTHCARE~2.75%;10GM/100ML~N~020734~002~~Sep
29, 1997~No~RX~BAXTER HEALTHCARE CORP
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~CLINIMIX 2.75/5 SULFITE FREE IN DEXTR
OSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~2.75%;5GM/100ML~N~020734~001~~Sep 29
, 1997~No~RX~BAXTER HEALTHCARE CORP
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~CLINIMIX 4.25/5 SULFITE FREE IN DEXTR
OSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~4.25%;5GM/100ML~N~020734~007~~Sep 29
, 1997~No~RX~BAXTER HEALTHCARE CORP
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~CLINIMIX 5/10 SULFITE FREE IN DEXTROS
E 10% IN PLASTIC CONTAINER~BAXTER HLTHCARE~5%;10GM/100ML~N~020734~014~~Sep 29, 1
997~No~RX~BAXTER HEALTHCARE CORP
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;261MG/100ML;217MG/100ML;112MG/10
0ML~N~020678~002~~Mar 26, 1997~Yes~RX~BAXTER HEALTHCARE CORP
0ML~N~020678~005~~Mar 26, 1997~Yes~RX~BAXTER HEALTHCARE CORP
5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER~BAXTER HL
THCARE~2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML
~N~020678~001~~Mar 26, 1997~Yes~RX~BAXTER HEALTHCARE CORP

ML~N~020678~009~~Mar 26, 1997~Yes~RX~BAXTER HEALTHCARE CORP
5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER~BAXTER HL
THCARE~4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML~
N~020678~008~~Mar 26, 1997~Yes~RX~BAXTER HEALTHCARE CORP
, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~CLINIMIX E 5/10
SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER~BAXTER HLT
HCARE~5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML~N~0
20678~016~~Mar 26, 1997~Yes~RX~BAXTER HEALTHCARE CORP
SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER~BAXTER HLT
AMINO ACIDS~INJECTABLE;INJECTION~CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER~
BAXTER HLTHCARE~15% (15GM/100ML)~A~020512~001~~Aug 30, 1996~No~RX~BAXTER HEALTHC
ARE CORP
OLIVE OIL; SOYBEAN OIL~INJECTABLE;INJECTION~CLINOLIPID 20%~BAXTER HLTHCARE~16%(1
60GM/1000ML);4% (40GM/1000ML)~N~204508~001~~Oct 3, 2013~Yes~RX~BAXTER HEALTHCAR
E CORP
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~EXELA PHARM
A SCS LLC~1MG/10ML (0.1MG/ML)~A~203167~001~AP~Oct 29, 2013~No~RX~EXELA PHARMA SC
IENCES LLC
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~EXELA PHARM
A SCS LLC~5MG/10ML (0.5MG/ML)~A~203167~002~AP~Oct 29, 2013~No~RX~EXELA PHARMA SC
IENCES LLC
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~FRESENIUS K
ABI USA~1MG/10ML (0.1MG/ML)~A~200673~001~AP~Jul 8, 2011~No~RX~FRESENIUS KABI USA
LLC
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~FRESENIUS K

ABI USA~5MG/10ML (0.5MG/ML)~A~200673~002~AP~Jul 8, 2011~No~RX~FRESENIUS KABI USA
LLC
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~HIKMA FARMA
CEUTICA~1MG/10ML (0.1MG/ML)~A~200300~001~AP~Jan 26, 2011~No~RX~HIKMA FARMACEUTIC
A (PORTUGAL) SA
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~HIKMA FARMA
CEUTICA~5MG/10ML (0.5MG/ML)~A~200300~002~AP~Jan 26, 2011~No~RX~HIKMA FARMACEUTIC
A (PORTUGAL) SA
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~LUITPOLD~1M
G/10ML (0.1MG/ML)~A~091104~001~AP~Oct 8, 2009~No~RX~LUITPOLD PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~LUITPOLD~5M
G/10ML (0.5MG/ML)~A~091104~002~AP~Oct 8, 2009~No~RX~LUITPOLD PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~ZYDUS PHARM
S USA INC~1MG/10ML (0.1MG/ML)~A~202601~001~AP~Feb 20, 2014~No~RX~ZYDUS PHARMACEU
TICALS USA INC
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~CLONIDINE HYDROCHLORIDE~ZYDUS PHARM
S USA INC~5MG/10ML (0.5MG/ML)~A~202601~002~AP~Feb 20, 2014~No~RX~ZYDUS PHARMACEU
TICALS USA INC
AMDINOCILLIN~INJECTABLE;INJECTION~COACTIN~ROCHE~1GM/VIAL~N~050565~003~~Dec 21, 1
AMDINOCILLIN~INJECTABLE;INJECTION~COACTIN~ROCHE~250MG/VIAL~N~050565~001~~Dec 21,
AMDINOCILLIN~INJECTABLE;INJECTION~COACTIN~ROCHE~500MG/VIAL~N~050565~002~~Dec 21,
CYANOCOBALAMIN~INJECTABLE;INJECTION~COBAVITE~WATSON LABS~0.1MG/ML~A~083013~001~~
CYANOCOBALAMIN~INJECTABLE;INJECTION~COBAVITE~WATSON LABS~1MG/ML~A~083064~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
BENZTROPINE MESYLATE~INJECTABLE;INJECTION~COGENTIN~OAK PHARMS AKORN~1MG/ML~N~012
015~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~OAK PHARMACEUTICALS INC SUB AKOR
N INC
COLISTIMETHATE SODIUM~INJECTABLE;INJECTION~COLISTIMETHATE SODIUM~EMCURE PHARMS L
TD~EQ 150MG BASE/VIAL~A~202359~001~AP~Sep 28, 2012~No~RX~EMCURE PHARMACEUTICALS
LTD
COLISTIMETHATE SODIUM~INJECTABLE;INJECTION~COLISTIMETHATE SODIUM~FRESENIUS KABI
USA~EQ 150MG BASE/VIAL~A~065364~001~AP~Apr 17, 2008~No~RX~FRESENIUS KABI USA LLC
COLISTIMETHATE SODIUM~INJECTABLE;INJECTION~COLISTIMETHATE SODIUM~PADDOCK LLC~EQ
150MG BASE/VIAL~A~065177~001~AP~Mar 19, 2004~No~RX~PADDOCK LABORATORIES LLC
COLISTIMETHATE SODIUM~INJECTABLE;INJECTION~COLISTIMETHATE SODIUM~SAGENT PHARMS~E
Q 150MG BASE/VIAL~A~201365~001~AP~Feb 19, 2014~No~RX~SAGENT PHARMACEUTICALS INC
COLISTIMETHATE SODIUM~INJECTABLE;INJECTION~COLISTIMETHATE SODIUM~X GEN PHARMS~EQ
150MG BASE/VIAL~A~064216~001~AP~Feb 26, 1999~No~RX~X GEN PHARMACEUTICALS INC
COLISTIMETHATE SODIUM~INJECTABLE;INJECTION~COLY-MYCIN M~PAR STERILE PRODUCTS~EQ
150MG BASE/VIAL~N~050108~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE
PRODUCTS LLC
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~COMPAZINE~GLAXOSMITHKLINE~EQ 5MG
BASE/ML~N~010742~002~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
IOTHALAMATE MEGLUMINE~INJECTABLE;INJECTION~CONRAY~LIEBEL-FLARSHEIM~60%~N~013295~
001~~Approved Prior to Jan 1, 1982~Yes~RX~LIEBEL-FLARSHEIM CO LLC
IOTHALAMATE MEGLUMINE~INJECTABLE;INJECTION~CONRAY 30~LIEBEL-FLARSHEIM~30%~N~0169
83~001~~Approved Prior to Jan 1, 1982~Yes~RX~LIEBEL-FLARSHEIM CO LLC
IOTHALAMATE SODIUM~INJECTABLE;INJECTION~CONRAY 325~MALLINCKRODT~54.3%~N~017685~0
IOTHALAMATE SODIUM~INJECTABLE;INJECTION~CONRAY 400~MALLINCKRODT~66.8%~N~014295~0
IOTHALAMATE MEGLUMINE~INJECTABLE;INJECTION~CONRAY 43~LIEBEL-FLARSHEIM~43%~N~0132
95~002~~Approved Prior to Jan 1, 1982~Yes~RX~LIEBEL-FLARSHEIM CO LLC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~CORDARONE~WYETH PHARMS INC~50MG/ML
~N~020377~001~~Aug 3, 1995~No~DISCN~WYETH PHARMACEUTICALS INC
FENOLDOPAM MESYLATE~INJECTABLE;INJECTION~CORLOPAM~HOSPIRA~EQ 10MG BASE/ML~N~0199

22~001~AP~Sep 23, 1997~Yes~RX~HOSPIRA INC
HYDROCORTISONE~INJECTABLE;INJECTION~CORTEF~PHARMACIA AND UPJOHN~50MG/ML~N~009864
~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~CORTEF ACETATE~PHARMACIA AND UPJOHN~
50MG/ML~N~009378~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOH
N CO
CORTICOTROPIN~INJECTABLE;INJECTION~CORTICOTROPIN~ORGANICS LAGRANGE~40 UNITS/ML~N
~010831~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANICS LAGRANGE INC
CORTICOTROPIN~INJECTABLE;INJECTION~CORTICOTROPIN~ORGANICS LAGRANGE~80 UNITS/ML~N
~010831~002~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANICS LAGRANGE INC
CORTICOTROPIN~INJECTABLE;INJECTION~CORTICOTROPIN~WATSON LABS~40 UNITS/VIAL~A~088
772~001~~Nov 21, 1984~No~DISCN~WATSON LABORATORIES INC
CORTISONE ACETATE~INJECTABLE;INJECTION~CORTISONE ACETATE~PHARMACIA AND UPJOHN~25
MG/ML~N~008126~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN
CO
CORTISONE ACETATE~INJECTABLE;INJECTION~CORTISONE ACETATE~WATSON LABS~25MG/ML~A~0
CORTISONE ACETATE~INJECTABLE;INJECTION~CORTONE~MERCK~25MG/ML~N~007110~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
CORTISONE ACETATE~INJECTABLE;INJECTION~CORTONE~MERCK~50MG/ML~N~007110~003~~Appro
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~CORTRIL~PFIZER~25MG/ML~N~009164~001~
~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
CORTICOTROPIN-ZINC HYDROXIDE~INJECTABLE;INJECTION~CORTROPHIN-ZINC~ORGANON USA IN
C~40 UNITS/ML~N~009854~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA I
NC
COSYNTROPIN~INJECTABLE;INJECTION~CORTROSYN~AMPHASTAR PHARMS INC~0.25MG/VIAL~N~01
6750~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~AMPHASTAR PHARMACEUTICALS INC
IBUTILIDE FUMARATE~INJECTABLE;INJECTION~CORVERT~PHARMACIA AND UPJOHN~0.1MG/ML~N~
020491~001~AP~Dec 28, 1995~Yes~RX~PHARMACIA AND UPJOHN CO
DACTINOMYCIN~INJECTABLE;INJECTION~COSMEGEN~RECORDATI RARE~0.5MG/VIAL~N~050682~00
1~AP~Approved Prior to Jan 1, 1982~Yes~RX~RECORDATI RARE DISEASES INC
COSYNTROPIN~INJECTABLE;INJECTION~COSYNTROPIN~MYLAN INSTITUTIONAL~0.25MG/VIAL~A~0
90574~001~AP~Dec 17, 2009~No~RX~MYLAN INSTITUTIONAL LLC
COSYNTROPIN~INJECTABLE;INJECTION~COSYNTROPIN~SANDOZ~0.25MG/VIAL~A~202147~001~AP~
Jun 29, 2012~No~RX~SANDOZ INC
WARFARIN SODIUM~INJECTABLE;INJECTION~COUMADIN~BRISTOL MYERS SQUIBB~5MG/VIAL~N~00
9218~024~~Feb 7, 1995~No~DISCN~BRISTOL MYERS SQUIBB PHARMA CO
09218~020~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB PHARMA CO
09218~012~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB PHARMA CO
SOMATROPIN~INJECTABLE;INJECTION~CRESCORMON~GENENTECH~4 IU/VIAL~N~017992~001~~App
roved Prior to Jan 1, 1982~No~DISCN~GENENTECH INC
DIGITOXIN~INJECTABLE;INJECTION~CRYSTODIGIN~LILLY~0.2MG/ML~A~084100~005~~Approved
Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
CUPRIC CHLORIDE~INJECTABLE;INJECTION~CUPRIC CHLORIDE IN PLASTIC CONTAINER~HOSPIR
A~EQ 0.4MG COPPER/ML~N~018960~001~~Jun 26, 1986~Yes~RX~HOSPIRA INC
CUPRIC SULFATE~INJECTABLE;INJECTION~CUPRIC SULFATE~ABRAXIS PHARM~EQ 0.4MG COPPER
/ML~N~019350~001~~May 5, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~ABRAXIS PHARM~0.03MG/ML~A~080
510~003~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~ABRAXIS PHARM~0.1MG/ML~A~0805

CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~ABRAXIS PHARM~1MG/ML~A~080510
~002~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~AKORN~1MG/ML~A~087969~001~~No
v 10, 1983~No~DISCN~AKORN INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~DELL LABS~0.03MG/ML~A~080689~
001~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~DELL LABS~0.1MG/ML~A~080689~0
02~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~DELL LABS~1MG/ML~A~080689~003
~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~EUROHLTH INTL SARL~1MG/ML~A~0
80515~002~~Approved Prior to Jan 1, 1982~No~DISCN~EUROHEALTH INTERNATIONAL SARL
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~FRESENIUS KABI USA~0.1MG/ML~A
~080557~002~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS KABI USA LLC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~LUITPOLD~0.03MG/ML~A~080668~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~LUITPOLD PHARMACEUTICALS INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~LUITPOLD~1MG/ML~A~080737~001~
AP~Approved Prior to Jan 1, 1982~Yes~RX~LUITPOLD PHARMACEUTICALS INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~LYPHOMED~1MG/ML~A~083075~001~
~Approved Prior to Jan 1, 1982~No~DISCN~LYPHOMED DIV FUJISAWA USA INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~MYLAN INSTITUTIONAL~1MG/ML~A~
040451~001~~Sep 23, 2003~No~DISCN~MYLAN INSTITUTIONAL LLC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~SANOFI AVENTIS US~1MG/ML~A~08
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~SOLOPAK~1MG/ML~A~087551~001~~
Feb 29, 1984~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~WARNER CHILCOTT~1MG/ML~N~0070
85~002~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~WATSON LABS~0.1MG/ML~A~080573
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~WATSON LABS~0.1MG/ML~A~083120
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~WATSON LABS~1MG/ML~A~080573~0
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~WATSON LABS~1MG/ML~A~083120~0
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~WYETH AYERST~0.1MG/ML~A~08055
CYANOCOBALAMIN~INJECTABLE;INJECTION~CYANOCOBALAMIN~WYETH AYERST~1MG/ML~A~080554~
HYDROXOCOBALAMIN~INJECTABLE;INJECTION~CYANOKIT~MERCK SANTE SAS~2.5GM/VIAL (5GM/K
IT)~N~022041~002~~Dec 15, 2006~No~DISCN~MERCK SANTE SAS
HYDROXOCOBALAMIN~INJECTABLE;INJECTION~CYANOKIT~MERCK SANTE SAS~5GM/VIAL (5GM/KIT
)~N~022041~001~~Apr 8, 2011~Yes~RX~MERCK SANTE SAS
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYCLOPHOSPHAMIDE~BAXTER HLTHCARE~1GM/VIAL~
A~040745~002~AP~May 21, 2008~Yes~RX~BAXTER HEALTHCARE CORP
A~088374~001~~Sep 24, 1986~No~DISCN~BAXTER HEALTHCARE CORP
A~040745~003~AP~May 21, 2008~Yes~RX~BAXTER HEALTHCARE CORP
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYCLOPHOSPHAMIDE~BAXTER HLTHCARE~100MG/VIA
L~A~088371~001~~Jul 3, 1986~No~DISCN~BAXTER HEALTHCARE CORP
L~A~040745~001~AP~May 21, 2008~Yes~RX~BAXTER HEALTHCARE CORP
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYCLOPHOSPHAMIDE~JIANGSU HENGRUI MED~1GM/V
IAL~A~204555~002~AP~Oct 31, 2014~No~RX~JIANGSU HENGRUI MEDICINE CO LTD

CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYCLOPHOSPHAMIDE~JIANGSU HENGRUI MED~2GM/V
IAL~A~204555~003~AP~Oct 31, 2014~No~RX~JIANGSU HENGRUI MEDICINE CO LTD
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYCLOPHOSPHAMIDE~JIANGSU HENGRUI MED~500MG
/VIAL~A~204555~001~AP~Oct 31, 2014~No~RX~JIANGSU HENGRUI MEDICINE CO LTD
CYCLOSPORINE~INJECTABLE;INJECTION~CYCLOSPORINE~EUROHLTH INTL SARL~50MG/ML~A~0650
04~001~AP~Oct 29, 1999~No~RX~EUROHEALTH INTERNATIONAL SARL
CYCLOSPORINE~INJECTABLE;INJECTION~CYCLOSPORINE~LUITPOLD~50MG/ML~A~065151~001~AP~
Oct 7, 2003~No~RX~LUITPOLD PHARMACEUTICALS INC
TRANEXAMIC ACID~INJECTABLE;INJECTION~CYKLOKAPRON~PHARMACIA AND UPJOHN~100MG/ML~N
~019281~001~AP~Dec 30, 1986~Yes~RX~PHARMACIA AND UPJOHN CO
CYSTEINE HYDROCHLORIDE~INJECTABLE;INJECTION~CYSTEINE HYDROCHLORIDE~HOSPIRA~7.25%
for safety or efficacy reasons**~N~019523~001~~Oct 22, 1986~No~DISCN~HOSPIRA IN
C
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~EUROHLTH INTL SARL~1GM/VIAL~A~074245~
001~AP~Aug 31, 1994~No~RX~EUROHEALTH INTERNATIONAL SARL
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~EUROHLTH INTL SARL~2GM/VIAL~A~074245~
002~AP~Aug 31, 1994~No~RX~EUROHEALTH INTERNATIONAL SARL
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~EUROHLTH INTL SARL~100MG/VIAL~A~07147
1~001~AP~Aug 2, 1989~No~RX~EUROHEALTH INTERNATIONAL SARL
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~EUROHLTH INTL SARL~500MG/VIAL~A~07147
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~FRESENIUS KABI USA~100MG/ML~A~076512~
001~AP~Jan 15, 2004~Yes~RX~FRESENIUS KABI USA LLC
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~HOSPIRA~20MG/ML~A~071868~001~AP~Jun 4
, 1990~Yes~RX~HOSPIRA INC
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~HOSPIRA~20MG/ML~A~072168~001~AP~Aug 3
1, 1990~Yes~RX~HOSPIRA INC
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~HOSPIRA~20MG/ML~A~072945~001~AP~Feb 2
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~HOSPIRA~100MG/ML~A~075383~001~AP~Nov
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~ONCO THERAPIES LTD~20MG/ML~A~200914~0
01~AP~Dec 13, 2011~No~RX~ONCO THERAPIES LTD
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~ONCO THERAPIES LTD~100MG/ML~A~201784~
001~AP~Jan 30, 2012~No~RX~ONCO THERAPIES LTD
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~TEVA PARENTERAL~1GM/VIAL~N~016793~003
~~Dec 21, 1987~No~DISCN~TEVA PARENTERAL MEDICINES INC
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~TEVA PARENTERAL~2GM/VIAL~N~016793~004
~~Dec 21, 1987~No~DISCN~TEVA PARENTERAL MEDICINES INC
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~TEVA PARENTERAL~100MG/VIAL~N~016793~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PARENTERAL MEDICINES INC
CYTARABINE~INJECTABLE;INJECTION~CYTARABINE~TEVA PARENTERAL~500MG/VIAL~N~016793~0
02~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PARENTERAL MEDICINES INC
CYTARABINE~INJECTABLE;INJECTION~CYTOSAR-U~TEVA PHARMS USA~1GM/VIAL~A~075206~004~
AP~Dec 30, 1998~Yes~RX~TEVA PHARMACEUTICALS USA
CYTARABINE~INJECTABLE;INJECTION~CYTOSAR-U~TEVA PHARMS USA~2GM/VIAL~A~075206~003~
AP~Dec 30, 1998~Yes~RX~TEVA PHARMACEUTICALS USA
CYTARABINE~INJECTABLE;INJECTION~CYTOSAR-U~TEVA PHARMS USA~100MG/VIAL~A~075206~00
1~AP~Dec 30, 1998~No~RX~TEVA PHARMACEUTICALS USA
CYTARABINE~INJECTABLE;INJECTION~CYTOSAR-U~TEVA PHARMS USA~500MG/VIAL~A~075206~00
2~AP~Dec 30, 1998~Yes~RX~TEVA PHARMACEUTICALS USA
GANCICLOVIR SODIUM~INJECTABLE;INJECTION~CYTOVENE~ROCHE PALO~EQ 500MG BASE/VIAL~N
~019661~001~AP~Jun 23, 1989~Yes~RX~ROCHE PALO ALTO LLC
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYTOXAN~BAXTER HLTHCARE~100MG/VIAL~N~01214
2~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP

CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYTOXAN~BAXTER HLTHCARE~200MG/VIAL~N~01214
2~002~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYTOXAN (LYOPHILIZED)~BAXTER HLTHCARE~1GM/
VIAL~N~012142~004~AP~Aug 30, 1982~Yes~RX~BAXTER HEALTHCARE CORP
VIAL~N~012142~010~~Sep 24, 1985~No~DISCN~BAXTER HEALTHCARE CORP
VIAL~N~012142~005~AP~Aug 30, 1982~Yes~RX~BAXTER HEALTHCARE CORP
VIAL~N~012142~009~~Dec 10, 1985~No~DISCN~BAXTER HEALTHCARE CORP
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYTOXAN (LYOPHILIZED)~BAXTER HLTHCARE~500M
G/VIAL~N~012142~003~AP~Approved Prior to Jan 1, 1982~Yes~RX~BAXTER HEALTHCARE CO
RP
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~CYTOXAN (LYOPHILIZED)~BAXTER HLTHCARE~500M
G/VIAL~N~012142~008~~Jan 4, 1984~No~DISCN~BAXTER HEALTHCARE CORP
DIHYDROERGOTAMINE MESYLATE~INJECTABLE;INJECTION~D.H.E. 45~VALEANT~1MG/ML~N~00592
9~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIO
NAL
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~ABRAXIS PHARM~100MG/VIAL~A~070962~0
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~ABRAXIS PHARM~200MG/VIAL~A~070990~0
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~EUROHLTH INTL SARL~200MG/VIAL~A~075
812~001~AP~Jun 15, 2001~No~RX~EUROHEALTH INTERNATIONAL SARL
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~EUROHLTH INTL SARL~500MG/VIAL~A~075
812~002~AP~Oct 31, 2002~No~RX~EUROHEALTH INTERNATIONAL SARL
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~FRESENIUS KABI USA~100MG/VIAL~A~075
371~001~AP~Aug 27, 1999~No~RX~FRESENIUS KABI USA LLC
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~FRESENIUS KABI USA~200MG/VIAL~A~075
371~002~AP~Aug 27, 1999~No~RX~FRESENIUS KABI USA LLC
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~HOSPIRA~200MG/VIAL~A~075940~001~AP~
Oct 18, 2001~No~RX~HOSPIRA INC
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~TEVA PHARMS USA~200MG/VIAL~A~075259
~002~AP~Aug 27, 1998~No~RX~TEVA PHARMACEUTICALS USA
DACARBAZINE~INJECTABLE;INJECTION~DACARBAZINE~TEVA PHARMS USA~500MG/VIAL~A~075259
~001~AP~Sep 22, 2000~Yes~RX~TEVA PHARMACEUTICALS USA
DACTINOMYCIN~INJECTABLE;INJECTION~DACTINOMYCIN~EUROHLTH INTL SARL~0.5MG/VIAL~A~0
90304~001~AP~Mar 16, 2010~No~RX~EUROHEALTH INTERNATIONAL SARL
DACTINOMYCIN~INJECTABLE;INJECTION~DACTINOMYCIN~LUITPOLD~0.5MG/VIAL~A~202562~001~
AP~Aug 23, 2013~No~RX~LUITPOLD PHARMACEUTICALS INC
DEZOCINE~INJECTABLE;INJECTION~DALGAN~ASTRAZENECA~5MG/ML~N~019082~001~~Dec 29, 19
89~No~DISCN~ASTRAZENECA LP
DANTROLENE SODIUM~INJECTABLE;INJECTION~DANTRIUM~PAR STERILE PRODUCTS~20MG/VIAL~N
~018264~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUCTS LLC
DAUNORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DAUNORUBICIN HYDROCHLORIDE~EUROH
LTH INTL SARL~EQ 5MG BASE/ML~N~050731~001~AP~Jan 30, 1998~Yes~RX~EUROHEALTH INTE
RNATIONAL SARL
DAUNORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DAUNORUBICIN HYDROCHLORIDE~FRESE
NIUS KABI USA~EQ 5MG BASE/VIAL~A~065034~001~~Nov 20, 2001~No~RX~FRESENIUS KABI U
SA LLC
DAUNORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DAUNORUBICIN HYDROCHLORIDE~FRESE
NIUS KABI USA~EQ 20MG BASE/VIAL~A~065000~001~AP~May 25, 1999~No~RX~FRESENIUS KAB
I USA LLC
DAUNORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DAUNORUBICIN HYDROCHLORIDE~TEVA
PARENTERAL~EQ 20MG BASE/VIAL~A~064212~001~~Jun 23, 1998~No~DISCN~TEVA PARENTERAL
MEDICINES INC
PARENTERAL~EQ 50MG BASE/VIAL~A~064212~002~~May 3, 1999~No~DISCN~TEVA PARENTERAL
MEDICINES INC
PHARMS USA~EQ 5MG BASE/ML~A~065035~001~AP~Jan 24, 2000~No~RX~TEVA PHARMACEUTICAL
S USA
DESMOPRESSIN ACETATE~INJECTABLE;INJECTION~DDAVP~FERRING PHARMS INC~0.004MG/ML~N~
018938~001~AP~Mar 30, 1984~Yes~RX~FERRING PHARMACEUTICALS INC
DESMOPRESSIN ACETATE~INJECTABLE;INJECTION~DDAVP~FERRING PHARMS INC~0.015MG/ML~N~
018938~002~~Apr 25, 1995~No~DISCN~FERRING PHARMACEUTICALS INC
NANDROLONE DECANOATE~INJECTABLE;INJECTION~DECA-DURABOLIN~AGI~50MG/ML~N~013132~00
1~~Jun 12, 1986~No~DISCN~ASPEN GLOBAL INC
DEXAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~DECADRON~MERCK~EQ 4MG PHOSPH
ATE/ML~N~012071~002~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
DEXAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~DECADRON~MERCK~EQ 24MG PHOSP
HATE/ML **Federal Register determination that product was not discontinued or wi
thdrawn for safety or efficacy reasons**~N~012071~004~~Approved Prior to Jan 1,
1982~No~DISCN~MERCK AND CO INC
DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~DEC
ADRON W/ XYLOCAINE~MERCK~EQ 4MG PHOSPHATE/ML;10MG/ML~N~013334~002~~Approved Prio
r to Jan 1, 1982~No~DISCN~MERCK AND CO INC
DEXAMETHASONE ACETATE~INJECTABLE;INJECTION~DECADRON-LA~MERCK~EQ 8MG BASE/ML **Fe
safety or efficacy reasons**~N~016675~001~~Approved Prior to Jan 1, 1982~No~DISC
N~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DEFEROXAMINE MESYLATE~EUROHLTH INTL S
ARL~2GM/VIAL~A~078086~002~AP~May 30, 2007~No~RX~EUROHEALTH INTERNATIONAL SARL
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DEFEROXAMINE MESYLATE~EUROHLTH INTL S
ARL~500MG/VIAL~A~078086~001~AP~May 30, 2007~No~RX~EUROHEALTH INTERNATIONAL SARL
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DEFEROXAMINE MESYLATE~FRESENIUS KABI
USA~2GM/VIAL~A~078718~002~AP~Sep 15, 2009~No~RX~FRESENIUS KABI USA LLC
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DEFEROXAMINE MESYLATE~FRESENIUS KABI
USA~500MG/VIAL~A~078718~001~AP~Sep 15, 2009~No~RX~FRESENIUS KABI USA LLC
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DEFEROXAMINE MESYLATE~HOSPIRA~2GM/VIA
L~A~076019~002~AP~Mar 17, 2004~No~RX~HOSPIRA INC
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DEFEROXAMINE MESYLATE~HOSPIRA~500MG/V
IAL~A~076019~001~AP~Mar 17, 2004~No~RX~HOSPIRA INC
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DEFEROXAMINE MESYLATE~WATSON LABS~2GM
/VIAL~A~076806~002~~Mar 31, 2006~No~DISCN~WATSON LABORATORIES INC
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DEFEROXAMINE MESYLATE~WATSON LABS~500
MG/VIAL~A~076806~001~~Mar 31, 2006~No~DISCN~WATSON LABORATORIES INC
HYDROXYPROGESTERONE CAPROATE~INJECTABLE;INJECTION~DELALUTIN~BRISTOL MYERS SQUIBB
~125MG/ML **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons**~N~010347~004~~Approved Prior to Jan 1
, 1982~No~DISCN~BRISTOL MYERS SQUIBB

TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~DELATESTRYL~ENDO PHARMS~200MG/ML~N~0
09165~001~~Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUTICALS INC
TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~DELATESTRYL~ENDO PHARMS~200MG/ML~N~0
09165~003~AO~Approved Prior to Jan 1, 1982~Yes~RX~ENDO PHARMACEUTICALS INC
ESTRADIOL VALERATE~INJECTABLE;INJECTION~DELESTROGEN~PAR STERILE PRODUCTS~10MG/ML
~N~009402~002~~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUCTS LLC
~N~009402~004~AO~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUCTS LLC
~N~009402~003~AO~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUCTS LLC
TORSEMIDE~INJECTABLE;INJECTION~DEMADEX~ROCHE~50MG/5ML (10MG/ML)~N~020137~002~~Au
g 23, 1993~No~DISCN~HOFFMANN LA ROCHE INC
TORSEMIDE~INJECTABLE;INJECTION~DEMADEX~ROCHE~20MG/2ML (10MG/ML)~N~020137~001~~Au
g 23, 1993~No~DISCN~HOFFMANN LA ROCHE INC
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~DEMEROL~HOSPIRA~25MG/ML~N~021171~0
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~DEMEROL~HOSPIRA~100MG/ML~N~021171~
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~DEMEROL~SANOFI AVENTIS US~25MG/ML~
N~005010~007~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~DEMEROL~SANOFI AVENTIS US~100MG/ML
~N~005010~003~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
VALPROATE SODIUM~INJECTABLE;INJECTION~DEPACON~ABBVIE~EQ 100MG BASE/ML~N~020593~0
01~AP~Dec 30, 1996~Yes~RX~ABBVIE INC
CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE~INJECTABLE;INJECTION~DEPINAR~ARMOUR PH
ARM~0.5MG/ML;2.3MG/ML;1MG/ML~N~011208~001~~Approved Prior to Jan 1, 1982~No~DISC
N~ARMOUR PHARMACEUTICAL CO
ESTRADIOL CYPIONATE~INJECTABLE;INJECTION~DEPO-ESTRADIOL~PHARMACIA AND UPJOHN~1MG
/ML~A~085470~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
/ML~A~085470~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
/ML~A~085470~003~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
METHYLPREDNISOLONE ACETATE~INJECTABLE;INJECTION~DEPO-MEDROL~PHARMACIA AND UPJOHN
~20MG/ML~N~011757~002~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN
CO
~40MG/ML~N~011757~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJO
HN CO
~80MG/ML~N~011757~004~AB~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJO
HN CO
MEDROXYPROGESTERONE ACETATE~INJECTABLE;INJECTION~DEPO-PROVERA~PHARMACIA AND UPJO
HN~100MG/ML **Federal Register determination that product was not discontinued o
r withdrawn for safety or efficacy reasons**~N~012541~002~~Approved Prior to Jan
1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
HN~150MG/ML~N~020246~001~AB~Oct 29, 1992~Yes~RX~PHARMACIA AND UPJOHN CO
HN~400MG/ML~N~012541~003~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJ
OHN CO
ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~DEPO-TESTADIOL~
PHARMACIA AND UPJOHN~2MG/ML;50MG/ML~N~017968~001~~Approved Prior to Jan 1, 1982~
No~DISCN~PHARMACIA AND UPJOHN CO
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~DEPO-TESTOSTERONE~PHARMACIA AND UPJO
HN~50MG/ML~A~085635~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UP
JOHN CO
HN~100MG/ML~A~085635~002~AO~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND U
PJOHN CO
HN~200MG/ML~A~085635~003~AO~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND U
PJOHN CO
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DESFERAL~NOVARTIS~2GM/VIAL~N~016267~0
02~AP~May 25, 2000~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
DEFEROXAMINE MESYLATE~INJECTABLE;INJECTION~DESFERAL~NOVARTIS~500MG/VIAL~N~016267
~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
DESMOPRESSIN ACETATE~INJECTABLE;INJECTION~DESMOPRESSIN ACETATE~BEDFORD~0.004MG/M
L~A~074575~001~~Feb 18, 2000~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORAT
ORIES INC
DESMOPRESSIN ACETATE~INJECTABLE;INJECTION~DESMOPRESSIN ACETATE~HOSPIRA~0.004MG/M
L~A~075220~001~AP~Aug 28, 2000~No~RX~HOSPIRA INC
DESMOPRESSIN ACETATE~INJECTABLE;INJECTION~DESMOPRESSIN ACETATE~SUN PHARM INDS LT
D~0.004MG/ML~A~091280~001~AP~Jan 25, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES LT
D
DESMOPRESSIN ACETATE~INJECTABLE;INJECTION~DESMOPRESSIN ACETATE~TEVA PHARMS USA~0
.004MG/ML~A~074888~001~AP~Oct 15, 1997~No~RX~TEVA PHARMACEUTICALS USA
DESMOPRESSIN ACETATE~INJECTABLE;INJECTION~DESMOPRESSIN ACETATE PRESERVATIVE FREE
~BEDFORD~0.004MG/ML~A~074574~001~~Feb 18, 2000~No~DISCN~BEDFORD LABORATORIES DIV
BEN VENUE LABORATORIES INC
DEXAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~DEXACEN-4~CENT PHARMS~EQ 4MG
PHOSPHATE/ML~A~084342~001~~Approved Prior to Jan 1, 1982~No~DISCN~CENTRAL PHARM
ACEUTICALS INC
DEXAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~DEXAMETHASONE~ABRAXIS PHARM~
EQ 4MG PHOSPHATE/ML~A~088448~001~~Jan 25, 1984~No~DISCN~ABRAXIS PHARMACEUTICAL P
RODUCTS
DEXAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~DEXAMETHASONE~FRESENIUS KABI
USA~EQ 10MG PHOSPHATE/ML~A~088469~001~~Jan 25, 1984~No~DISCN~FRESENIUS KABI USA
LLC
DEXAMETHASONE ACETATE~INJECTABLE;INJECTION~DEXAMETHASONE ACETATE~WATSON LABS~EQ
8MG BASE/ML~A~084315~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATO
RIES INC
DEXAMETHASONE ACETATE~INJECTABLE;INJECTION~DEXAMETHASONE ACETATE~WATSON LABS~EQ
16MG BASE/ML~A~087711~001~~May 24, 1982~No~DISCN~WATSON LABORATORIES INC
DEXAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~DEXAMETHASONE SODIUM PHOSPHA
TE~AGILA SPECLTS~EQ 4MG PHOSPHATE/ML~A~040803~001~AP~Aug 29, 2008~No~RX~AGILA SP
ECIALTIES PRIVATE LTD
TE~AGILA SPECLTS~EQ 10MG PHOSPHATE/ML~A~040802~001~AP~Aug 29, 2008~No~RX~AGILA S
PECIALTIES PRIVATE LTD
TE~AKORN~EQ 4MG PHOSPHATE/ML~A~084493~001~~Approved Prior to Jan 1, 1982~No~DISC
N~AKORN INC
TE~BEL MAR~EQ 4MG PHOSPHATE/ML~A~084752~001~~Approved Prior to Jan 1, 1982~No~DI
SCN~BEL MAR LABORATORIES INC
TE~DELL LABS~EQ 4MG PHOSPHATE/ML~A~083161~001~~Approved Prior to Jan 1, 1982~No~
DISCN~DELL LABORATORIES INC
TE~EUROHLTH INTL SARL~EQ 10MG PHOSPHATE/ML~A~087702~001~AP~Sep 7, 1982~Yes~RX~EU

ROHEALTH INTERNATIONAL SARL
TE~FRESENIUS KABI USA~EQ 4MG PHOSPHATE/ML~A~084916~001~AP~Approved Prior to Jan
1, 1982~No~RX~FRESENIUS KABI USA LLC
TE~FRESENIUS KABI USA~EQ 10MG PHOSPHATE/ML~A~040491~001~AP~Apr 11, 2003~Yes~RX~F
RESENIUS KABI USA LLC
TE~FRESENIUS KABI USA~EQ 10MG PHOSPHATE/ML~A~040572~001~AP~Apr 22, 2005~Yes~RX~F
TE~HIKMA MAPLE ~EQ 4MG PHOSPHATE/ML~A~084282~001~~Approved Prior to Jan 1, 1982~
No~DISCN~HIKMA MAPLE LTD
TE~INTL MEDICATION~EQ 20MG PHOSPHATE/ML~A~088522~001~~Feb 17, 1984~No~DISCN~INTE
RNATIONAL MEDICATION SYSTEMS LTD
TE~LUITPOLD~EQ 4MG PHOSPHATE/ML~A~087440~001~AP~Jul 21, 1982~Yes~RX~LUITPOLD PHA
RMACEUTICALS INC
TE~LYPHOMED~EQ 4MG PHOSPHATE/ML~A~087065~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~LYPHOMED DIV FUJISAWA USA INC
TE~TEVA PARENTERAL~EQ 4MG PHOSPHATE/ML~A~081125~001~~Aug 31, 1990~No~DISCN~TEVA
PARENTERAL MEDICINES INC
TE~TEVA PARENTERAL~EQ 10MG PHOSPHATE/ML~A~081126~001~~Aug 31, 1990~No~DISCN~TEVA
TE~WATSON LABS~EQ 4MG PHOSPHATE/ML~A~083702~001~~Approved Prior to Jan 1, 1982~N
TE~WATSON LABS~EQ 4MG PHOSPHATE/ML~A~084355~001~~Approved Prior to Jan 1, 1982~N
TE~WATSON LABS~EQ 4MG PHOSPHATE/ML~A~089169~001~~Apr 9, 1986~No~DISCN~WATSON LAB
ORATORIES INC
TE~WATSON LABS~EQ 10MG PHOSPHATE/ML~A~087668~001~~Jul 1, 1982~No~DISCN~WATSON LA
BORATORIES INC
TE~WATSON LABS~EQ 24MG PHOSPHATE/ML~A~085606~001~~Approved Prior to Jan 1, 1982~
TE~WYETH AYERST~EQ 4MG PHOSPHATE/ML~A~085641~001~~Approved Prior to Jan 1, 1982~
No~DISCN~WYETH AYERST LABORATORIES
IRON DEXTRAN~INJECTABLE;INJECTION~DEXFERRUM~LUITPOLD~EQ 50MG IRON/ML~N~040024~00
1~BP~Feb 23, 1996~No~RX~LUITPOLD PHARMACEUTICALS INC
DEXMEDETOMIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~DEXMEDETOMIDINE HYDROCHLORIDE
~AKORN INC~EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)~A~202585~001~AP~Nov 24, 2014~N
o~RX~AKORN INC
~MYLAN INSTITUTIONAL~EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)~A~202881~001~AP~Aug
18, 2014~No~RX~MYLAN INSTITUTIONAL LLC
~PAR STERILE PRODUCTS~EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)~A~203972~001~AP~Aug
18, 2014~No~RX~PAR STERILE PRODUCTS LLC
DEXRAZOXANE HYDROCHLORIDE~INJECTABLE;INJECTION~DEXRAZOXANE HYDROCHLORIDE~EUROHLT
H INTL SARL~EQ 250MG BASE/VIAL~A~076068~001~AP~Sep 28, 2004~No~RX~EUROHEALTH INT
ERNATIONAL SARL
DEXRAZOXANE HYDROCHLORIDE~INJECTABLE;INJECTION~DEXRAZOXANE HYDROCHLORIDE~EUROHLT
H INTL SARL~EQ 500MG BASE/VIAL~A~076068~002~AP~Sep 28, 2004~No~RX~EUROHEALTH INT
ERNATIONAL SARL
DEXRAZOXANE HYDROCHLORIDE~INJECTABLE;INJECTION~DEXRAZOXANE HYDROCHLORIDE~MYLAN I
NSTITUTIONAL~EQ 250MG BASE/VIAL~A~200752~001~AP~Oct 19, 2011~No~RX~MYLAN INSTITU
TIONAL LLC
DEXRAZOXANE HYDROCHLORIDE~INJECTABLE;INJECTION~DEXRAZOXANE HYDROCHLORIDE~MYLAN I
NSTITUTIONAL~EQ 500MG BASE/VIAL~A~200752~002~AP~Oct 19, 2011~No~RX~MYLAN INSTITU
TIONAL LLC
DEXTROSE; SODIUM CHLORIDE~INJECTABLE;INJECTION~DEXTROSE 10% AND SODIUM CHLORIDE
0.11% IN PLASTIC CONTAINER~B BRAUN~10GM/100ML;110MG/100ML~N~019631~011~~Feb 24,
1988~No~RX~B BRAUN MEDICAL INC
0.2% IN PLASTIC CONTAINER~B BRAUN~10GM/100ML;200MG/100ML~N~018386~001~~Approved
Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
0.2% IN PLASTIC CONTAINER~B BRAUN~10GM/100ML;200MG/100ML~N~019631~012~~Feb 24, 1
0.9% IN PLASTIC CONTAINER~B BRAUN~10GM/100ML;900MG/100ML~N~019631~015~AP~Feb 24,
0.9% IN PLASTIC CONTAINER~BAXTER HLTHCARE~10GM/100ML;900MG/100ML~N~016696~001~AP
~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 10% IN PLASTIC CONTAINER~B BRAUN~10GM/100
ML~N~018046~001~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
ML~N~019626~004~AP~Feb 2, 1988~Yes~RX~B BRAUN MEDICAL INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 10% IN PLASTIC CONTAINER~BAXTER HLTHCARE~
10GM/100ML~N~016694~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~BAXTER HEALTHCAR
E CORP
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 10% IN PLASTIC CONTAINER~HOSPIRA~10GM/100
ML~N~018080~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 10% IN PLASTIC CONTAINER~MILES~10GM/100ML
~N~018504~001~~Approved Prior to Jan 1, 1982~No~DISCN~MILES LABORATORIES INC
DEXTROSE; SODIUM CHLORIDE~INJECTABLE;INJECTION~DEXTROSE 2.5% AND SODIUM CHLORIDE
0.11% IN PLASTIC CONTAINER~B BRAUN~2.5GM/100ML;110MG/100ML~N~019631~001~~Feb 24
, 1988~No~RX~B BRAUN MEDICAL INC
0.2% IN PLASTIC CONTAINER~B BRAUN~2.5GM/100ML;200MG/100ML~N~019631~002~~Feb 24,
0.33% IN PLASTIC CONTAINER~B BRAUN~2.5GM/100ML;330MG/100ML~N~019631~003~~Feb 24
, 1988~No~RX~B BRAUN MEDICAL INC
0.45% IN PLASTIC CONTAINER~B BRAUN~2.5GM/100ML;450MG/100ML~N~018030~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC

0.45% IN PLASTIC CONTAINER~B BRAUN~2.5GM/100ML;450MG/100ML~N~019631~004~AP~Feb
24, 1988~No~RX~B BRAUN MEDICAL INC
0.45% IN PLASTIC CONTAINER~BAXTER HLTHCARE~2.5GM/100ML;450MG/100ML~N~016697~001
~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
0.45% IN PLASTIC CONTAINER~HOSPIRA~2.5GM/100ML;450MG/100ML~N~018096~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
0.9% IN PLASTIC CONTAINER~B BRAUN~2.5GM/100ML;900MG/100ML~N~018376~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
0.9% IN PLASTIC CONTAINER~B BRAUN~2.5GM/100ML;900MG/100ML~N~019631~005~~Feb 24,
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE~
INJECTABLE;INJECTION~DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC
CONTAINER~B BRAUN~10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100ML~N~0
19634~001~~Feb 24, 1988~No~RX~B BRAUN MEDICAL INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 2.5% IN PLASTIC CONTAINER~B BRAUN~2.5GM/1
00ML~N~018358~001~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
00ML~N~019626~001~~Feb 2, 1988~No~DISCN~B BRAUN MEDICAL INC
E CORP
ML~N~018564~001~AP~Mar 23, 1982~Yes~RX~HOSPIRA INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 25%~HOSPIRA~250MG/ML~N~019445~002~~Nov 23
, 1998~Yes~RX~HOSPIRA INC
0.3% IN PLASTIC CONTAINER~ABBOTT~3.3GM/100ML;300MG/100ML~N~018055~001~~Approved
Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
0.3% IN PLASTIC CONTAINER~B BRAUN~3.3GM/100ML;300MG/100ML~N~019631~016~~Jan 19,
E CORP
ML~N~019345~001~AP~Jan 26, 1985~Yes~RX~HOSPIRA INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 38.5% IN PLASTIC CONTAINER~ABBOTT~38.5GM/
100ML~N~018923~001~~Sep 19, 1984~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRO
DUCTS DIV
INJECTABLE;INJECTION~DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAI
NER~B BRAUN~4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100ML~N~019634~002~~F
eb 24, 1988~No~DISCN~B BRAUN MEDICAL INC
E CORP
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; S
ODIUM LACTATE~INJECTABLE;INJECTION~DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC
CONTAINER~BAXTER HLTHCARE~5GM/100ML;205MG/100ML;100MG/100ML;120MG/100ML;220MG/10
0ML~N~018840~001~~Jun 29, 1983~No~RX~BAXTER HEALTHCARE CORP
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC
; SODIUM CHLORIDE; SODIUM LACTATE~INJECTABLE;INJECTION~DEXTROSE 5% AND ELECTROLY
TE NO.48 IN PLASTIC CONTAINER~BAXTER HLTHCARE~5GM/100ML;31MG/100ML;141MG/100ML;2
0MG/100ML;12MG/100ML;260MG/100ML~N~017484~001~~Approved Prior to Jan 1, 1982~No~

RX~BAXTER HEALTHCARE CORP
INJECTABLE;INJECTION~DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER~HOSP
IRA~20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML~N~017608~001~AP~Appr
oved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
DEXTROSE; POTASSIUM CHLORIDE~INJECTABLE;INJECTION~DEXTROSE 5% AND POTASSIUM CHLO
RIDE 0.075% IN PLASTIC CONTAINER~BAXTER HLTHCARE~5GM/100ML;75MG/100ML~N~017634~0
04~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
RIDE 0.224% IN PLASTIC CONTAINER~BAXTER HLTHCARE~5GM/100ML;224MG/100ML~N~017634~
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJEC
TION~DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER~HOSPIRA~33MG/100ML;5GM/100ML;
30MG/100ML;860MG/100ML~N~018254~001~AP~Approved Prior to Jan 1, 1982~No~RX~HOSPI
RA INC
DEXTROSE; SODIUM CHLORIDE~INJECTABLE;INJECTION~DEXTROSE 5% AND SODIUM CHLORIDE 0
.11% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;110MG/100ML~N~018030~005~~Approved P
rior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
.11% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;110MG/100ML~N~019631~006~~Feb 24, 19
.2% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;200MG/100ML~N~018030~004~~Approved Pr
ior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
.2% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;200MG/100ML~N~019631~007~AP~Feb 24, 1
.2% IN PLASTIC CONTAINER~MILES~5GM/100ML;200MG/100ML~N~018399~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~MILES LABORATORIES INC
.225% IN PLASTIC CONTAINER~ABBOTT~5GM/100ML;225MG/100ML~N~019482~001~~Oct 4, 198
.225% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;225MG/100ML~N~017606~001~~Approved
Prior to Jan 1, 1982~No~RX~HOSPIRA INC
.3% IN PLASTIC CONTAINER~ABBOTT~5GM/100ML;300MG/100ML~N~019486~001~~Oct 4, 1985~
No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
.3% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;300MG/100ML~N~017799~001~~Approved Pr
ior to Jan 1, 1982~No~RX~HOSPIRA INC
.33% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;330MG/100ML~N~019631~008~AP~Feb 24,
.45% IN PLASTIC CONTAINER~ABBOTT~5GM/100ML;450MG/100ML~N~019484~001~~Oct 4, 1985
~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

.45% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;450MG/100ML~N~019631~009~AP~Feb 24,
.45% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;450MG/100ML~N~017607~001~AP~Approved
.45% IN PLASTIC CONTAINER~MILES~5GM/100ML;450MG/100ML~N~018400~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~MILES LABORATORIES INC
.9% IN PLASTIC CONTAINER~ABBOTT~5GM/100ML;900MG/100ML~N~019483~001~~Oct 4, 1985~
No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
.9% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;900MG/100ML~N~018026~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
.9% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;900MG/100ML~N~019631~010~AP~Feb 24, 1
.9% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;900MG/100ML~N~017585~001~AP~Approved
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE~
INJECTABLE;INJECTION~DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER~B BRA
UN~20MG/100ML;5GM/100ML;30MG/100ML;380MG/100ML;600MG/100ML~N~018258~001~~Approve
d Prior to Jan 1, 1982~Yes~RX~B BRAUN MEDICAL INC
INJECTABLE;INJECTION~DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER~B BRA
UN~20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML~N~017510~001~~Approve
INJECTABLE;INJECTION~DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER~B BRA
UN~20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML~N~019634~003~AP~Feb 2
INJECTABLE;INJECTION~DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER~MILES
~20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML~N~018499~001~~Approved
Prior to Jan 1, 1982~No~DISCN~MILES LABORATORIES INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML
~N~016730~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~B BRAUN MEDICAL INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML
~N~019626~002~AP~Feb 2, 1988~Yes~RX~B BRAUN MEDICAL INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~B BRAUN~50MG/ML~N
~016730~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~B BRAUN MEDICAL INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~5
GM/100ML~N~016673~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~BAXTER HEALTHCARE
CORP
GM/100ML~N~020179~001~AP~Dec 7, 1992~Yes~RX~BAXTER HEALTHCARE CORP
0MG/ML~N~016673~003~AP~Oct 30, 1985~Yes~RX~BAXTER HEALTHCARE CORP
0MG/ML~N~020179~002~AP~Dec 7, 1992~Yes~RX~BAXTER HEALTHCARE CORP
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~DHL~5GM/100ML~N~0
19971~001~~Sep 28, 1995~No~DISCN~DHL LABORATORIES INC

DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML
~N~019466~001~AP~Jul 15, 1985~Yes~RX~HOSPIRA INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML
~N~019479~001~AP~Sep 17, 1985~Yes~RX~HOSPIRA INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~50MG/ML~N
~016367~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~50MG/ML~N
~019222~001~AP~Jul 13, 1984~Yes~RX~HOSPIRA INC
TION~DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER~B BRAUN~33MG/100ML;5GM/100ML;3
0MG/100ML;860MG/100ML~N~018256~001~~Approved Prior to Jan 1, 1982~No~DISCN~B BRA
UN MEDICAL INC
TION~DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER~B BRAUN~33MG/100ML;5GM/100ML;3
0MG/100ML;860MG/100ML~N~020000~001~AP~Apr 17, 1992~No~RX~B BRAUN MEDICAL INC
TION~DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER~BAXTER HLTHCARE~33MG/100ML;5GM
/100ML;30MG/100ML;860MG/100ML~N~016695~001~~Approved Prior to Jan 1, 1982~No~DIS
DEXTROSE; SODIUM CHLORIDE~INJECTABLE;INJECTION~DEXTROSE 5% IN SODIUM CHLORIDE 0.
2% IN PLASTIC CONTAINER~BAXTER HLTHCARE~5GM/100ML;200MG/100ML~N~016689~001~AP~Ap
proved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
33% IN PLASTIC CONTAINER~BAXTER HLTHCARE~5GM/100ML;330MG/100ML~N~016687~001~AP~A
pproved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
45% IN PLASTIC CONTAINER~BAXTER HLTHCARE~5GM/100ML;450MG/100ML~N~016683~001~AP~A
pproved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
9% IN PLASTIC CONTAINER~BAXTER HLTHCARE~5GM/100ML;900MG/100ML~N~016678~001~AP~Ap
proved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
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~N~018268~009~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL
INC
SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER~B BRAUN~5
GM/100ML;150MG/100ML;200MG/100ML~N~018268~004~~Approved Prior to Jan 1, 1982~No~
DISCN~B BRAUN MEDICAL INC
SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER~B BRAUN~
5GM/100ML;220MG/100ML;200MG/100ML~N~018268~005~~Approved Prior to Jan 1, 1982~No
~DISCN~B BRAUN MEDICAL INC
SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~B BRAUN~5G
M/100ML;300MG/100ML;200MG/100ML~N~018268~006~~Approved Prior to Jan 1, 1982~No~D
ISCN~B BRAUN MEDICAL INC
SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ~BAXTER HLTHCARE~5GM/100ML;75MG
/100ML;200MG/100ML~N~018037~006~AP~Apr 13, 1982~No~RX~BAXTER HEALTHCARE CORP
SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ~BAXTER HLTHCARE~5GM/100ML;150M
G/100ML;200MG/100ML~N~018037~007~AP~Apr 13, 1982~No~RX~BAXTER HEALTHCARE CORP
SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)~BAXTER HLTHCARE~5GM/100ML;
224MG/100ML;200MG/100ML~N~018037~004~AP~Approved Prior to Jan 1, 1982~No~RX~BAXT
ER HEALTHCARE CORP

SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)~BAXTER HLTHCARE~5GM/100ML;
300MG/100ML;200MG/100ML~N~018037~001~AP~Approved Prior to Jan 1, 1982~No~RX~BAXT
ER HEALTHCARE CORP
SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ~BAXTER HLTHCARE~5GM/100ML;75MG/
100ML;200MG/100ML~N~018037~002~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEA
LTHCARE CORP
SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)~BAXTER HLTHCARE~5GM/100ML;1
50MG/100ML;200MG/100ML~N~018037~003~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTE
R HEALTHCARE CORP
SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER~B BRAUN
~5GM/100ML;75MG/100ML;330MG/100ML~N~018268~011~~Jan 18, 1986~No~DISCN~B BRAUN ME
DICAL INC
5GM/100ML;150MG/100ML;330MG/100ML~N~018268~012~~Jan 18, 1986~No~DISCN~B BRAUN ME
DICAL INC
DICAL INC
DICAL INC
SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER~BAXTER H
LTHCARE~5GM/100ML;75MG/100ML;330MG/100ML~N~018629~005~AP~Mar 23, 1982~No~RX~BAXT
ER HEALTHCARE CORP
LTHCARE~5GM/100ML;150MG/100ML;330MG/100ML~N~018629~002~AP~Mar 23, 1982~No~RX~BAX
TER HEALTHCARE CORP
TER HEALTHCARE CORP
TER HEALTHCARE CORP
TER HEALTHCARE CORP
TER HEALTHCARE CORP

TER HEALTHCARE CORP
SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER~BAXTER HL
THCARE~5GM/100ML;75MG/100ML;330MG/100ML~N~018629~001~AP~Mar 23, 1982~No~RX~BAXTE
R HEALTHCARE CORP
SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%~B BRAUN~5GM/100ML;75MG/100ML
;450MG/100ML~N~018268~010~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICA
L INC
SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~B BRAUN~5
GM/100ML;300MG/100ML;450MG/100ML~N~018268~003~~Approved Prior to Jan 1, 1982~No~
DISCN~B BRAUN MEDICAL INC
LTHCARE~5GM/100ML;224MG/100ML;450MG/100ML~N~018008~003~~Approved Prior to Jan 1,
SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER~BAXT
ER HLTHCARE~5GM/100ML;300MG/100ML;450MG/100ML~N~018008~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP
SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER~BAXT
ER HLTHCARE~5GM/100ML;300MG/100ML;450MG/100ML~N~018008~010~AP~Approved Prior to
Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER~BAXTER HL
THCARE~5GM/100ML;75MG/100ML;450MG/100ML~N~018008~002~~Approved Prior to Jan 1, 1
E CORP
50GM/100ML~N~020047~001~AP~Jul 2, 1991~Yes~RX~BAXTER HEALTHCARE CORP
ML~N~019894~001~AP~Dec 26, 1989~Yes~RX~HOSPIRA INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 50% IN PLASTIC CONTAINER~HOSPIRA~500MG/ML
~N~019445~001~AP~Jun 3, 1986~No~RX~HOSPIRA INC
DEXTROSE~INJECTABLE;INJECTION~DEXTROSE 60%~B BRAUN~60GM/100ML~N~017995~002~~Sep
22, 1982~No~DISCN~B BRAUN MEDICAL INC
60GM/100ML~N~017521~005~AP~Mar 26, 1982~Yes~RX~BAXTER HEALTHCARE CORP
60GM/100ML~N~020047~002~~Jul 2, 1991~No~DISCN~BAXTER HEALTHCARE CORP
ML~N~019346~001~~Jan 25, 1985~No~DISCN~HOSPIRA INC

00ML~N~019626~003~~Feb 2, 1988~No~DISCN~B BRAUN MEDICAL INC
70GM/100ML~N~017521~006~AP~Mar 26, 1982~Yes~RX~BAXTER HEALTHCARE CORP
70GM/100ML~N~020047~003~AP~Jul 2, 1991~Yes~RX~BAXTER HEALTHCARE CORP
ML~N~019893~001~AP~Dec 26, 1989~Yes~RX~HOSPIRA INC
ACETAZOLAMIDE SODIUM~INJECTABLE;INJECTION~DIAMOX~TEVA WOMENS~EQ 500MG BASE/VIAL
for safety or efficacy reasons**~N~009388~001~~Dec 5, 1990~No~DISCN~TEVA WOMENS
HEALTH INC
DIATRIZOATE MEGLUMINE~INJECTABLE;INJECTION~DIATRIZOATE MEGLUMINE~BRACCO~76%~N~01
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~DIATRIZOATE-60~IN
TL MEDICATION~52%;8%~A~088166~001~~Jun 17, 1983~No~DISCN~INTERNATIONAL MEDICATIO
N SYSTEMS LTD
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~ABRAXIS PHARM~5MG/ML~A~070662~001~~Jun 25
, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~HIKMA MAPLE ~5MG/ML~A~070311~001~~Dec 16,
1985~No~DISCN~HIKMA MAPLE LTD
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~HIKMA MAPLE ~5MG/ML~A~071308~001~~Jul 17,
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~HOSPIRA~5MG/ML~A~071583~001~AP~Oct 13, 19
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~HOSPIRA~5MG/ML~A~071584~001~~Oct 13, 1987
~No~DISCN~HOSPIRA WORLDWIDE, INC
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~HOSPIRA~5MG/ML~A~072079~001~AP~Dec 20, 19
88~No~RX~HOSPIRA INC
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~MARSAM PHARMS LLC~5MG/ML~A~072371~001~~Ja
n 29, 1993~No~DISCN~MARSAM PHARMACEUTICALS LLC
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~PARENTA PHARMS~5MG/ML~A~076815~001~~Apr 1
5, 2004~No~DISCN~PARENTA PHARMACEUTICALS INC
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~US ARMY~5MG/ML~N~020124~001~~Dec 5, 1990~
No~DISCN~US ARMY MEDICAL RESEARCH MATERIEL COMMAND
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~WARNER CHILCOTT~5MG/ML~A~071613~001~~Oct
22, 1987~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~WARNER CHILCOTT~5MG/ML~A~071614~001~~Oct
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~WATSON LABS~5MG/ML~A~070296~001~~Feb 12,
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~WATSON LABS~5MG/ML~A~070911~001~~Aug 28,
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~WATSON LABS~5MG/ML~A~070912~001~~Aug 28,
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~WATSON LABS~5MG/ML~A~070930~001~~Dec 1, 1
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~WATSON LABS INC~5MG/ML~A~072370~001~~Jan
DIAZEPAM~INJECTABLE;INJECTION~DIAZEPAM~WATSON LABS INC~5MG/ML~A~072397~001~~Jan

DIAZOXIDE~INJECTABLE;INJECTION~DIAZOXIDE~ABRAXIS PHARM~15MG/ML~A~071519~001~~Aug
26, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
PROCAINE MERETHOXYLLINE; THEOPHYLLINE~INJECTABLE;INJECTION~DICURIN PROCAINE~LILL
Y~100MG/ML;50MG/ML~N~008869~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILL
Y AND CO
DICYCLOMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DICYCLOMINE HYDROCHLORIDE~WATSON
LABS~10MG/ML~A~080614~001~~Feb 11, 1986~No~DISCN~WATSON LABORATORIES INC
DICYCLOMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DICYCLOMINE HYDROCHLORIDE (PRESER
VATIVE-FREE)~EUROHLTH INTL SARL~10MG/ML~A~040465~001~AP~Jun 30, 2003~No~RX~EUROH
EALTH INTERNATIONAL SARL
ETIDRONATE DISODIUM~INJECTABLE;INJECTION~DIDRONEL~MGI PHARMA INC~50MG/ML~N~01954
5~001~~Apr 20, 1987~No~DISCN~MGI PHARMA INC
FLUCONAZOLE~INJECTABLE;INJECTION~DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER~PF
IZER~200MG/100ML (2MG/ML)~N~019950~003~AP~Sep 29, 1992~Yes~RX~PFIZER INC
FLUCONAZOLE~INJECTABLE;INJECTION~DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER~PF
IZER~400MG/200ML (2MG/ML)~N~019950~005~AP~Jul 8, 1994~Yes~RX~PFIZER INC
FLUCONAZOLE~INJECTABLE;INJECTION~DIFLUCAN IN SODIUM CHLORIDE 0.9%~PFIZER~200MG/1
00ML (2MG/ML)~N~019950~001~AP~Jan 29, 1990~Yes~RX~PFIZER INC
FLUCONAZOLE~INJECTABLE;INJECTION~DIFLUCAN IN SODIUM CHLORIDE 0.9%~PFIZER~400MG/2
00ML (2MG/ML)~N~019950~006~AP~Jan 29, 1990~Yes~RX~PFIZER INC
FLUCONAZOLE~INJECTABLE;INJECTION~DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CON
TAINER~PFIZER~200MG/100ML (2MG/ML)~N~019950~002~AP~Jan 29, 1990~Yes~RX~PFIZER IN
C
FLUCONAZOLE~INJECTABLE;INJECTION~DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CON
TAINER~PFIZER~400MG/200ML (2MG/ML)~N~019950~004~AP~Jan 29, 1990~Yes~RX~PFIZER IN
C
DIGOXIN~INJECTABLE;INJECTION~DIGOXIN~ABRAXIS PHARM~0.25MG/ML~A~083217~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
DIGOXIN~INJECTABLE;INJECTION~DIGOXIN~EUROHLTH INTL SARL~0.25MG/ML~A~083391~001~A
P~Approved Prior to Jan 1, 1982~No~RX~EUROHEALTH INTERNATIONAL SARL
DIGOXIN~INJECTABLE;INJECTION~DIGOXIN~HOSPIRA~0.25MG/ML~A~040093~001~~May 16, 199
6~No~DISCN~HOSPIRA INC
DIGOXIN~INJECTABLE;INJECTION~DIGOXIN~HOSPIRA~0.25MG/ML~A~040206~001~~Aug 28, 199
DIGOXIN~INJECTABLE;INJECTION~DIGOXIN~SANDOZ~0.25MG/ML~A~040481~001~AP~Aug 21, 20
03~No~RX~SANDOZ CANADA INC
DIGOXIN~INJECTABLE;INJECTION~DIGOXIN~WYETH AYERST~0.25MG/ML~A~084386~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
DIGOXIN~INJECTABLE;INJECTION~DIGOXIN PEDIATRIC~HOSPIRA~0.1MG/ML~A~040092~001~~Ap
r 25, 1996~No~DISCN~HOSPIRA INC
DIHYDROERGOTAMINE MESYLATE~INJECTABLE;INJECTION~DIHYDROERGOTAMINE MESYLATE~BEDFO
RD LABS~1MG/ML~A~040453~001~AP~Jun 9, 2003~No~RX~BEDFORD LABORATORIES
DIHYDROERGOTAMINE MESYLATE~INJECTABLE;INJECTION~DIHYDROERGOTAMINE MESYLATE~PADDO
CK LLC~1MG/ML~A~040475~001~AP~Apr 28, 2003~No~RX~PADDOCK LABORATORIES LLC
PHENYTOIN SODIUM~INJECTABLE;INJECTION~DILANTIN~PARKE DAVIS~50MG/ML~N~010151~001~
~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS PHARMACEUTICAL RESEARCH DIV
WARNER LAMBERT CO
HYDROMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~DILAUDID~PURDUE PHARM PRODS~1MG
/ML~N~019034~003~AP~Apr 30, 2009~Yes~RX~PURDUE PHARMACEUTICAL PRODUCTS LP
HYDROMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~DILAUDID-HP~PURDUE PHARM PRODS~
10MG/ML~N~019034~001~AP~Jan 11, 1984~Yes~RX~PURDUE PHARMACEUTICAL PRODUCTS LP
HYDROMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~DILAUDID-HP~PURDUE PHARM PRODS~
250MG/VIAL~N~019034~002~~Aug 4, 1994~Yes~RX~PURDUE PHARMACEUTICAL PRODUCTS LP
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~AGILA SPECL
TS~5MG/ML~A~075375~001~~Sep 30, 1999~No~DISCN~AGILA SPECIALTIES PRIVATE LTD
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~AKORN INC~5

MG/ML~A~075086~001~AP~Apr 9, 1998~No~RX~AKORN INC
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~BEDFORD~5MG
/ML~A~074617~001~AP~Feb 28, 1996~Yes~RX~BEDFORD LABORATORIES DIV BEN VENUE LABOR
ATORIES INC
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~HIKMA FARMA
CEUTICA~5MG/ML~A~202651~001~AP~Aug 9, 2012~No~RX~HIKMA FARMACEUTICA PORTUGAL SA
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~HIKMA MAPLE
~5MG/ML~A~078538~001~AP~Dec 17, 2008~No~RX~HIKMA MAPLE LTD
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~HOSPIRA~5MG
/ML~A~074941~001~AP~Apr 15, 1998~No~RX~HOSPIRA INC
/ML~A~075004~001~~Feb 16, 2000~No~DISCN~HOSPIRA INC
/ML~A~075106~001~~Apr 29, 1999~No~DISCN~HOSPIRA INC
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~HOSPIRA~100
MG/VIAL~A~075853~001~~Dec 17, 2002~Yes~RX~HOSPIRA INC
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~INTL MEDICA
TION~5MG/ML~A~075749~001~AP~Nov 21, 2001~No~RX~INTERNATIONAL MEDICATION SYSTEMS
LTD
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~TEVA PHARMS
USA~5MG/ML~A~074894~001~~Aug 26, 1997~No~DISCN~TEVA PHARMACEUTICALS USA
DILTIAZEM HYDROCHLORIDE~INJECTABLE;INJECTION~DILTIAZEM HYDROCHLORIDE~TEVA PHARMS
USA~10MG/ML~A~074894~002~~Apr 19, 2002~Yes~RX~TEVA PHARMACEUTICALS USA
DIMENHYDRINATE~INJECTABLE;INJECTION~DIMENHYDRINATE~BAXTER HLTHCARE~50MG/ML~A~084
767~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESI
A AND CRITICAL CARE
DIMENHYDRINATE~INJECTABLE;INJECTION~DIMENHYDRINATE~FRESENIUS KABI USA~50MG/ML~A~
040519~001~~Jun 23, 2004~Yes~RX~FRESENIUS KABI USA LLC
DIMENHYDRINATE~INJECTABLE;INJECTION~DIMENHYDRINATE~WATSON LABS~50MG/ML~A~080615~
DIMENHYDRINATE~INJECTABLE;INJECTION~DIMENHYDRINATE~WATSON LABS~50MG/ML~A~083531~
DIMENHYDRINATE~INJECTABLE;INJECTION~DIMENHYDRINATE~WYETH AYERST~50MG/ML~A~084316
BROMPHENIRAMINE MALEATE~INJECTABLE;INJECTION~DIMETANE-TEN~WYETH AYERST~10MG/ML~N
~011418~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
DIPHENHYDRAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DIPHENHYDRAMINE HYDROCHLORIDE
~APP PHARMS~50MG/ML~A~040466~001~AP~May 28, 2002~No~RX~APP PHARMACEUTICALS LLC
~BEL MAR~10MG/ML~A~080822~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LA
BORATORIES INC
~HIKMA MAPLE ~50MG/ML~A~080817~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA
MAPLE LTD
~HIKMA MAPLE ~50MG/ML~A~083183~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA
MAPLE LTD
~HOSPIRA~50MG/ML~A~040140~001~AP~Nov 20, 1998~No~RX~HOSPIRA INC
~LYPHOMED~10MG/ML~A~087066~001~~Approved Prior to Jan 1, 1982~No~DISCN~LYPHOMED
DIV FUJISAWA USA INC
~MYLAN INSTITUTIONAL~50MG/ML~A~040498~001~AP~Jul 12, 2005~No~RX~MYLAN INSTITUTIO
NAL LLC
~WATSON LABS~10MG/ML~A~083533~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON
LABORATORIES INC
~WATSON LABS INC~10MG/ML~A~080873~001~~Approved Prior to Jan 1, 1982~No~DISCN~WA

TSON LABORATORIES INC
~WATSON LABS INC~50MG/ML~A~080873~002~~Approved Prior to Jan 1, 1982~No~DISCN~WA
~WYETH AYERST~50MG/ML~A~080577~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH
AYERST LABORATORIES
PRESERVATIVE FREE~ABRAXIS PHARM~50MG/ML~A~080586~002~~Approved Prior to Jan 1,
1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
PRESERVATIVE FREE~BD RX~50MG/ML~A~091526~001~AP~Mar 26, 2013~No~RX~BD RX INC
PRESERVATIVE FREE~INTL MEDICATION~50MG/ML~A~084094~001~~Approved Prior to Jan 1
, 1982~No~DISCN~INTERNATIONAL MEDICATION SYSTEM
PRESERVATIVE FREE~WATSON LABS INC~50MG/ML~A~080873~003~~Approved Prior to Jan 1
, 1982~No~DISCN~WATSON LABORATORIES INC
PROPOFOL~INJECTABLE;INJECTION~DIPRIVAN~FRESENIUS KABI USA~10MG/ML~N~019627~001~~
Oct 2, 1989~No~DISCN~FRESENIUS KABI USA LLC
PROPOFOL~INJECTABLE;INJECTION~DIPRIVAN~FRESENIUS KABI USA~10MG/ML~N~019627~002~A
B~Jun 11, 1996~Yes~RX~FRESENIUS KABI USA LLC
DIPYRIDAMOLE~INJECTABLE;INJECTION~DIPYRIDAMOLE~AGILA SPECLTS~5MG/ML~A~075769~001
~~Nov 27, 2002~No~DISCN~AGILA SPECIALTIES PRIVATE LTD
DIPYRIDAMOLE~INJECTABLE;INJECTION~DIPYRIDAMOLE~BEDFORD~5MG/ML~A~074939~001~AP~Ap
r 13, 1998~Yes~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
DIPYRIDAMOLE~INJECTABLE;INJECTION~DIPYRIDAMOLE~FRESENIUS KABI USA~5MG/ML~A~07495
6~001~AP~Sep 30, 1998~No~RX~FRESENIUS KABI USA LLC
DIPYRIDAMOLE~INJECTABLE;INJECTION~DIPYRIDAMOLE~HIKMA MAPLE ~5MG/ML~A~074521~001~
AP~Oct 18, 1996~No~RX~HIKMA MAPLE LTD
DIPYRIDAMOLE~INJECTABLE;INJECTION~DIPYRIDAMOLE~HOSPIRA~5MG/ML~A~074601~001~~Dec
19, 1997~No~DISCN~HOSPIRA WORLDWIDE, INC
DIPYRIDAMOLE~INJECTABLE;INJECTION~DIPYRIDAMOLE~TEVA PHARMS USA~5MG/ML~A~074952~0
01~~Nov 26, 1997~No~DISCN~TEVA PHARMACEUTICALS USA
CHYMOPAPAIN~INJECTABLE;INJECTION~DISCASE~ABBOTT~12,500 UNITS/VIAL~N~018625~001~~
Jan 18, 1984~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~DITATE-DS~SAVAGE
LABS~8MG/ML;180MG/ML~A~086423~001~~Approved Prior to Jan 1, 1982~No~DISCN~SAVAG
E LABORATORIES INC DIV ALTANA INC
CHLOROTHIAZIDE SODIUM~INJECTABLE;INJECTION~DIURIL~OAK PHARMS AKORN~EQ 500MG BASE
/VIAL~N~011145~005~AP~Approved Prior to Jan 1, 1982~Yes~RX~OAK PHARMACEUTICALS I
NC SUB AKORN INC
DIAZEPAM~INJECTABLE;INJECTION~DIZAC~PHARMACIA AND UPJOHN~5MG/ML~N~019287~001~~Ju
n 18, 1993~No~DISCN~PHARMACIA AND UPJOHN CO
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTAMINE HYDROCHLORIDE~ASTRAZENE
CA~EQ 12.5MG BASE/ML~A~074098~001~~Feb 21, 1995~No~DISCN~ASTRAZENECA LP
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTAMINE HYDROCHLORIDE~BAXTER HL
THCARE~EQ 12.5MG BASE/ML~A~074381~001~~Sep 26, 1996~No~DISCN~BAXTER HEALTHCARE C
ORP ANESTHESIA AND CRITICAL CARE
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTAMINE HYDROCHLORIDE~EUROHLTH
INTL SARL~EQ 12.5MG BASE/ML~A~074277~001~AP~Oct 31, 1994~No~RX~EUROHEALTH INTERN
ATIONAL SARL
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTAMINE HYDROCHLORIDE~HOSPIRA~E
Q 1.25GM BASE/100ML~A~074634~001~~Sep 27, 1996~No~DISCN~HOSPIRA INC
Q 12.5MG BASE/ML~A~074086~001~AP~Nov 29, 1993~No~RX~HOSPIRA INC
Q 12.5MG BASE/ML~A~074292~001~AP~Feb 16, 1995~Yes~RX~HOSPIRA WORLDWIDE, INC
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTAMINE HYDROCHLORIDE~LUITPOLD~
EQ 12.5MG BASE/ML~A~074545~001~~Jun 25, 1998~No~DISCN~LUITPOLD PHARMACEUTICALS I

NC
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTAMINE HYDROCHLORIDE~TEVA PARE
NTERAL~EQ 12.5MG BASE/ML~A~074206~001~~Oct 19, 1993~No~DISCN~TEVA PARENTERAL MED
ICINES INC
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTAMINE HYDROCHLORIDE~WATSON LA
BS~EQ 12.5MG BASE/ML~A~074114~001~~Nov 30, 1993~No~DISCN~WATSON LABORATORIES INC
BS INC~EQ 12.5MG BASE/ML~A~074279~001~~Feb 18, 1998~No~DISCN~WATSON LABORATORIES
INC
BS INC~EQ 12.5MG BASE/ML~A~074995~001~~Mar 31, 1998~No~DISCN~WATSON LABORATORIES
INC
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTAMINE HYDROCHLORIDE IN DEXTRO
SE 5%~HOSPIRA~EQ 50MG BASE/100ML~N~020269~001~~Oct 19, 1993~No~DISCN~HOSPIRA INC
SE 5%~HOSPIRA~EQ 100MG BASE/100ML~N~020269~002~~Oct 19, 1993~No~DISCN~HOSPIRA IN
C
SE 5%~HOSPIRA~EQ 200MG BASE/100ML~N~020269~003~~Oct 19, 1993~No~DISCN~HOSPIRA IN
C
SE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~EQ 50MG BASE/100ML~N~020255~001~AP~Oc
t 19, 1993~Yes~RX~BAXTER HEALTHCARE CORP
SE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~EQ 100MG BASE/100ML~N~020255~003~AP~O
ct 19, 1993~Yes~RX~BAXTER HEALTHCARE CORP
SE 5% IN PLASTIC CONTAINER~HOSPIRA~EQ 50MG BASE/100ML~N~020201~003~AP~Oct 19, 19
SE 5% IN PLASTIC CONTAINER~HOSPIRA~EQ 400MG BASE/100ML~N~020201~006~AP~Jul 7, 19
DOBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOBUTREX~LILLY~EQ 12.5MG BASE/ML~N
~017820~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
DESOXYCORTICOSTERONE ACETATE~INJECTABLE;INJECTION~DOCA~ORGANON USA INC~5MG/ML~N~
001104~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
DOCETAXEL~INJECTABLE;INJECTION~DOCEFREZ~SUN PHARMA GLOBAL~20MG/VIAL~N~022534~001
~~May 3, 2011~Yes~RX~SUN PHARMA GLOBAL FZE
DOCETAXEL~INJECTABLE;INJECTION~DOCEFREZ~SUN PHARMA GLOBAL~80MG/VIAL~N~022534~002
~~May 3, 2011~Yes~RX~SUN PHARMA GLOBAL FZE
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~ACCORD HLTHCARE~20MG/0.5ML (40MG/ML)~N~
201195~001~~Jun 8, 2011~No~RX~ACCORD HEALTHCARE INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~ACCORD HLTHCARE~20MG/ML (20MG/ML)~N~201
195~003~AP~Apr 20, 2012~No~RX~ACCORD HEALTHCARE INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~ACCORD HLTHCARE~80MG/2ML (40MG/ML)~N~20
1195~002~~Jun 8, 2011~No~RX~ACCORD HEALTHCARE INC
1195~004~AP~Apr 20, 2012~No~RX~ACCORD HEALTHCARE INC

01195~005~AP~Apr 20, 2012~Yes~RX~ACCORD HEALTHCARE INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~ACTAVIS INC~20MG/ML (20MG/ML)~N~203551~
001~AP~Apr 12, 2013~No~RX~ACTAVIS INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~ACTAVIS INC~80MG/4ML (20MG/ML)~N~203551
~002~AP~Apr 12, 2013~No~RX~ACTAVIS INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~ACTAVIS INC~140MG/7ML (20MG/ML)~N~20355
1~003~~Apr 12, 2013~No~RX~ACTAVIS INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~APOTEX INC~20MG/0.5ML (40MG/ML)~N~02231
2~001~~Jan 11, 2012~No~DISCN~APOTEX INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~APOTEX INC~80MG/2ML (40MG/ML)~N~022312~
002~~Jan 11, 2012~No~DISCN~APOTEX INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~DR REDDYS LABS LTD~20MG/ML (20MG/ML)~A~
204193~001~AP~Nov 5, 2014~No~RX~DR REDDYS LABORATORIES LTD
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~DR REDDYS LABS LTD~80MG/4ML (20MG/ML)~A
~204193~002~AP~Nov 5, 2014~No~RX~DR REDDYS LABORATORIES LTD
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~HOSPIRA INC~20MG/2ML (10MG/ML)~N~022234
~001~AP~Mar 8, 2011~Yes~RX~HOSPIRA INC
~002~AP~Mar 8, 2011~Yes~RX~HOSPIRA INC
34~003~AP~Mar 8, 2011~Yes~RX~HOSPIRA INC
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~PFIZER LABS~20MG/2ML (10MG/ML)~N~202356
~001~~Mar 13, 2014~No~RX~PFIZER LABS
~002~~Mar 13, 2014~No~RX~PFIZER LABS
56~003~~Mar 13, 2014~No~RX~PFIZER LABS
56~004~~Mar 13, 2014~No~RX~PFIZER LABS
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~SANDOZ~20MG/2ML (10MG/ML)~N~201525~001~
AP~Jun 29, 2011~No~RX~SANDOZ
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~SANDOZ~80MG/8ML (10MG/ML)~N~201525~002~
AP~Jun 29, 2011~No~RX~SANDOZ
DOCETAXEL~INJECTABLE;INJECTION~DOCETAXEL~SANDOZ~160MG/16ML (10MG/ML)~N~201525~00
3~AP~Jun 29, 2011~No~RX~SANDOZ
METHADONE HYDROCHLORIDE~INJECTABLE;INJECTION~DOLOPHINE HYDROCHLORIDE~MYLAN INSTI
TUTIONAL~10MG/ML~N~021624~001~~Approved Prior to Jan 1, 1982~Yes~RX~MYLAN INSTIT
UTIONAL LLC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~ABBOTT~40MG/M
L~A~070656~001~~Jan 24, 1989~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~ABBOTT~80MG/M
L~A~070657~001~~Jan 24, 1989~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~ABRAXIS PHARM
~40MG/ML~A~070012~001~~Jun 12, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
~40MG/ML~A~070058~001~~Mar 20, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
~80MG/ML~A~070013~001~~Jun 12, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
~80MG/ML~A~070059~001~~Mar 20, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
~160MG/ML~A~070364~001~~Dec 4, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~ASTRAZENECA~4
0MG/ML~A~070087~001~~Oct 23, 1985~No~DISCN~ASTRAZENECA LP
0MG/ML~N~018656~001~~Jun 28, 1983~No~DISCN~ASTRAZENECA LP

DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~BAXTER HLTHCA
RE~40MG/ML~N~018398~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCAR
E CORP ANESTHESIA AND CRITICAL CARE
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~BAXTER HLTHCA
RE~80MG/ML~N~018398~002~~Mar 22, 1982~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA
AND CRITICAL CARE
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~HOSPIRA~40MG/
ML~A~074403~001~~May 23, 1996~No~DISCN~HOSPIRA INC
ML~N~018132~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
100ML~N~018132~002~AP~Feb 4, 1982~Yes~RX~HOSPIRA INC
ML~N~018132~004~AP~Jul 9, 1982~Yes~RX~HOSPIRA INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~HOSPIRA~160MG
/100ML~N~018132~003~AP~Feb 4, 1982~Yes~RX~HOSPIRA INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~INTL MEDICATI
ON~40MG/ML~N~018014~001~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL ME
DICATION SYSTEM
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~LUITPOLD~40MG
/ML~A~070799~001~AP~Feb 11, 1987~Yes~RX~LUITPOLD PHARMACEUTICALS INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~LUITPOLD~80MG
/ML~A~070820~001~AP~Feb 11, 1987~Yes~RX~LUITPOLD PHARMACEUTICALS INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~LUITPOLD~160M
G/ML~A~070826~001~AP~Feb 11, 1987~Yes~RX~LUITPOLD PHARMACEUTICALS INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~LYPHOMED~40MG
/ML~N~018549~001~~Mar 11, 1983~No~DISCN~LYPHOMED DIV FUJISAWA USA INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~SMITH AND NEP
HEW~40MG/ML~A~070011~001~~Aug 29, 1985~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMI
TH AND NEPHEW
TH AND NEPHEW
TH AND NEPHEW
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~TEVA PARENTER
AL~40MG/ML~A~072999~001~~Oct 23, 1991~No~DISCN~TEVA PARENTERAL MEDICINES INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~TEVA PARENTER
AL~80MG/ML~A~073000~001~~Oct 23, 1991~No~DISCN~TEVA PARENTERAL MEDICINES INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE~WARNER CHILCO
TT~40MG/ML~A~070558~001~~Sep 20, 1985~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBER
T CO
TT~40MG/ML~N~018138~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT
TT~80MG/ML~A~070559~001~~Sep 20, 1985~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBER
T CO
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE AND DEXTROSE
5%~B BRAUN~80MG/100ML~N~019099~002~AP~Oct 15, 1986~Yes~RX~B BRAUN MEDICAL INC

5%~B BRAUN~320MG/100ML~N~019099~004~AP~Oct 15, 1986~Yes~RX~B BRAUN MEDICAL INC
5% IN PLASTIC CONTAINER~B BRAUN~40MG/100ML~N~019099~001~~Oct 15, 1986~Yes~RX~B B
RAUN MEDICAL INC
5% IN PLASTIC CONTAINER~B BRAUN~160MG/100ML~N~019099~003~AP~Oct 15, 1986~Yes~RX~
B BRAUN MEDICAL INC
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~DOPAMINE HYDROCHLORIDE IN DEXTROSE 5
%~HOSPIRA~1.6MG/ML~N~020542~001~~Aug 30, 1995~No~DISCN~HOSPIRA INC
% IN PLASTIC CONTAINER~BAXTER HLTHCARE~80MG/100ML~N~019615~001~AP~Mar 27, 1987~Y
es~RX~BAXTER HEALTHCARE CORP
% IN PLASTIC CONTAINER~BAXTER HLTHCARE~160MG/100ML~N~019615~002~AP~Mar 27, 1987~
Yes~RX~BAXTER HEALTHCARE CORP
% IN PLASTIC CONTAINER~BAXTER HLTHCARE~320MG/100ML~N~019615~003~AP~Mar 27, 1987~
Yes~RX~BAXTER HEALTHCARE CORP
% IN PLASTIC CONTAINER~BAXTER HLTHCARE~640MG/100ML~N~019615~004~~Mar 27, 1987~Ye
s~RX~BAXTER HEALTHCARE CORP
% IN PLASTIC CONTAINER~HOSPIRA~80MG/100ML~N~018826~001~AP~Sep 30, 1983~Yes~RX~HO
SPIRA INC
% IN PLASTIC CONTAINER~HOSPIRA~160MG/100ML~N~018826~002~AP~Sep 30, 1983~Yes~RX~H
OSPIRA INC
% IN PLASTIC CONTAINER~HOSPIRA~320MG/100ML~N~018826~003~AP~Sep 30, 1983~Yes~RX~H
OSPIRA INC
DOXAPRAM HYDROCHLORIDE~INJECTABLE;INJECTION~DOPRAM~HIKMA MAPLE ~20MG/ML~N~014879
~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE LTD
DOXAPRAM HYDROCHLORIDE~INJECTABLE;INJECTION~DOXAPRAM HYDROCHLORIDE~BEDFORD~20MG/
ML~A~076266~001~AP~Jan 10, 2003~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORAT
ORIES INC
DOXAPRAM HYDROCHLORIDE~INJECTABLE;INJECTION~DOXAPRAM HYDROCHLORIDE~WATSON LABS~2
0MG/ML~A~073529~001~~Jan 30, 1992~No~DISCN~WATSON LABORATORIES INC
DOXERCALCIFEROL~INJECTABLE;INJECTION~DOXERCALCIFEROL~HIKMA PHARMS LLC~4MCG/2ML (
2MCG/ML)~A~091101~001~AP~Aug 30, 2013~No~RX~HIKMA PHARMACEUTICALS LLC
DOXERCALCIFEROL~INJECTABLE;INJECTION~DOXERCALCIFEROL~SANDOZ~4MCG/2ML (2MCG/ML)~A
~091333~001~AP~May 5, 2014~No~RX~SANDOZ INC
DOXERCALCIFEROL~INJECTABLE;INJECTION~DOXERCALCIFEROL~SANDOZ~4MCG/2ML (2MCG/ML)~A
~200926~001~AP~Feb 4, 2014~No~RX~SANDOZ INC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~ACTAVIS
INC~2MG/ML~A~203622~001~AP~Jun 27, 2014~No~RX~ACTAVIS INC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~ALVOGEN
INC~2MG/ML~A~065515~001~AP~Nov 8, 2012~No~RX~ALVOGEN INC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~EUROHLT
H INTL SARL~2MG/ML~A~062975~001~AP~Mar 17, 1989~Yes~RX~EUROHEALTH INTERNATIONAL
SARL
H INTL SARL~10MG/VIAL~A~062921~001~AP~Mar 17, 1989~Yes~RX~EUROHEALTH INTERNATION
AL SARL
AL SARL
AL SARL
H INTL SARL~200MG/100ML~A~064097~001~AP~Sep 13, 1994~Yes~RX~EUROHEALTH INTERNATI
ONAL SARL
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~FRESENI
US KABI USA~2MG/ML~A~063277~001~AP~Oct 26, 1995~No~RX~FRESENIUS KABI USA LLC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~ONCO TH
ERAPIES LTD~2MG/ML~A~200901~001~AP~Feb 14, 2012~No~RX~ONCO THERAPIES LTD
ERAPIES LTD~10MG/VIAL~A~200170~001~AP~Oct 28, 2011~No~RX~ONCO THERAPIES LTD
ERAPIES LTD~50MG/VIAL~A~200170~002~AP~Oct 28, 2011~No~RX~ONCO THERAPIES LTD
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~PHARMAC
HEMIE BV~2MG/ML~A~063336~001~AP~Feb 28, 1995~No~RX~PHARMACHEMIE BV
HEMIE BV~10MG/VIAL~A~063097~001~AP~May 21, 1990~No~RX~PHARMACHEMIE BV
HEMIE BV~200MG/100ML~A~063336~004~AP~Feb 28, 1995~No~RX~PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~SAGENT
PHARMS~2MG/ML~A~091495~001~AP~Mar 18, 2013~No~RX~SAGENT PHARMACEUTICALS INC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~SANDOZ
INC~2MG/ML~A~200146~001~AP~Jul 18, 2012~No~RX~SANDOZ INC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~SUN PHA
RM INDS~2MG/ML~A~091418~001~AP~Feb 15, 2012~No~RX~SUN PHARMACEUTICAL INDUSTRIES
LTD
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~TEVA PH
ARMS USA~2MG/ML~A~064140~001~AP~Jul 28, 1995~No~RX~TEVA PHARMACEUTICALS USA
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~DOXORUBICIN HYDROCHLORIDE~TEVA PH
ARMS USA~200MG/100ML~A~064140~002~AP~Jul 28, 1995~No~RX~TEVA PHARMACEUTICALS USA
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXY 100~FRESENIUS KABI USA~EQ 100MG BA
SE/VIAL~A~062475~001~AP~Dec 9, 1983~Yes~RX~FRESENIUS KABI USA LLC
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXY 200~FRESENIUS KABI USA~EQ 200MG BA
SE/VIAL~A~062475~002~~Dec 9, 1983~Yes~RX~FRESENIUS KABI USA LLC
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXYCHEL HYCLATE~RACHELLE~EQ 100MG BASE
/VIAL~A~061953~001~~Approved Prior to Jan 1, 1982~No~DISCN~RACHELLE LABORATORIES
INC
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXYCYCLINE~AGILA SPECLTS~EQ 100MG BASE
/VIAL~A~091406~001~AP~Aug 21, 2012~No~RX~AGILA SPECIALTIES PRIVATE LTD
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXYCYCLINE~EUROHLTH INTL SARL~EQ 100MG
BASE/VIAL~A~062569~001~AP~Mar 9, 1988~Yes~RX~EUROHEALTH INTERNATIONAL SARL
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXYCYCLINE~EUROHLTH INTL SARL~EQ 200MG
BASE/VIAL~A~062569~002~~Mar 9, 1988~No~DISCN~EUROHEALTH INTERNATIONAL SARL
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXYCYCLINE~HIKMA MAPLE ~EQ 100MG BASE/
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXYCYCLINE~HIKMA MAPLE ~EQ 200MG BASE/
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXYCYCLINE HYCLATE~HIKMA MAPLE ~EQ 100
MG BASE/VIAL~A~062992~001~~Feb 16, 1989~No~DISCN~HIKMA MAPLE LTD
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~DOXYCYCLINE HYCLATE~HIKMA MAPLE ~EQ 200
MG BASE/VIAL~A~062992~002~~Feb 16, 1989~No~DISCN~HIKMA MAPLE LTD
TECHNETIUM TC-99M MEDRONATE~INJECTABLE;INJECTION~DRAXIMAGE MDP-10~JUBILANT DRAXI
MAGE~N/A~N~018035~001~~Approved Prior to Jan 1, 1982~No~DISCN~JUBILANT DRAXIMAGE
INC
TECHNETIUM TC-99M MEDRONATE~INJECTABLE;INJECTION~DRAXIMAGE MDP-25~JUBILANT DRAXI
MAGE~N/A~N~018035~002~~Feb 27, 2004~Yes~RX~JUBILANT DRAXIMAGE INC
DROMOSTANOLONE PROPIONATE~INJECTABLE;INJECTION~DROLBAN~LILLY~50MG/ML~N~012936~00

DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~ABRAXIS PHARM~2.5MG/ML~A~070992~001~~
Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~ABRAXIS PHARM~2.5MG/ML~A~070993~001~~
Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~ASTRAZENECA~2.5MG/ML~A~072018~001~~Oc
t 20, 1988~No~DISCN~ASTRAZENECA LP
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~HOSPIRA~2.5MG/ML~A~071645~001~~Apr 7,
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~HOSPIRA~2.5MG/ML~A~071981~001~AP~Feb
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~HOSPIRA~2.5MG/ML~A~072272~001~~Aug 31
, 1995~No~DISCN~HOSPIRA INC
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~LUITPOLD~2.5MG/ML~A~072123~001~AP~Oct
24, 1988~No~RX~LUITPOLD PHARMACEUTICALS INC
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~LUITPOLD~2.5MG/ML~A~072335~001~~Oct 2
4, 1988~No~DISCN~LUITPOLD PHARMACEUTICALS INC
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~SMITH AND NEPHEW~2.5MG/ML~A~071750~00
1~~Sep 6, 1988~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~SOLOPAK~2.5MG/ML~A~071754~001~~Sep 6,
1988~No~DISCN~SOLOPAK LABORATORIES INC
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~SOLOPAK~2.5MG/ML~A~071755~001~~Sep 6,
1988~No~DISCN~SOLOPAK LABORATORIES INC
DROPERIDOL~INJECTABLE;INJECTION~DROPERIDOL~WATSON LABS~2.5MG/ML~A~073520~001~~No
v 27, 1991~No~DISCN~WATSON LABORATORIES INC
DACARBAZINE~INJECTABLE;INJECTION~DTIC-DOME~BAYER HLTHCARE~100MG/VIAL~N~017575~00
1~AP~Approved Prior to Jan 1, 1982~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
DACARBAZINE~INJECTABLE;INJECTION~DTIC-DOME~BAYER HLTHCARE~200MG/VIAL~N~017575~00
2~AP~Approved Prior to Jan 1, 1982~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
TECHNETIUM TC-99M PENTETATE KIT~INJECTABLE;INJECTION~DTPA~DRAXIMAGE~N/A~N~018511
~001~AP~Dec 29, 1989~No~RX~DRAXIMAGE INC
BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~DUOCAINE
~AMPHASTAR PHARMS INC~EQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML)~N~021496~001~~M
ay 23, 2003~No~DISCN~AMPHASTAR PHARMACEUTICALS INC
NANDROLONE PHENPROPIONATE~INJECTABLE;INJECTION~DURABOLIN~ORGANON USA INC~25MG/ML
~N~011891~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
NANDROLONE PHENPROPIONATE~INJECTABLE;INJECTION~DURABOLIN~ORGANON USA INC~50MG/ML
~N~011891~002~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~DURACILLIN A.S.~LILLY~300,000 UNITS/M
L~A~060093~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~DURACLON~MYLAN INSTITUTIONAL~1MG/10
ML (0.1MG/ML)~N~020615~001~AP~Oct 2, 1996~No~RX~MYLAN INSTITUTIONAL LLC
CLONIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~DURACLON~MYLAN INSTITUTIONAL~5MG/10
ML (0.5MG/ML)~N~020615~002~AP~Apr 27, 1999~Yes~RX~MYLAN INSTITUTIONAL LLC
MORPHINE SULFATE~INJECTABLE;INJECTION~DURAMORPH PF~HIKMA MAPLE ~0.5MG/ML~N~01856
5~001~AP~Sep 18, 1984~Yes~RX~HIKMA MAPLE LTD
MORPHINE SULFATE~INJECTABLE;INJECTION~DURAMORPH PF~HIKMA MAPLE ~1MG/ML~N~018565~
002~AP~Sep 18, 1984~Yes~RX~HIKMA MAPLE LTD
EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~DURANEST~ASTRAZENECA~
0.005MG/ML;0.5%~N~017751~004~~Approved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA
LP
EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~DURANEST~A
STRAZENECA~0.005MG/ML;1%~N~017751~006~~Approved Prior to Jan 1, 1982~No~DISCN~AS
TRAZENECA LP
EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~DURANEST~A
STRAZENECA~0.005MG/ML;1.5%~N~017751~007~~Approved Prior to Jan 1, 1982~No~DISCN~
ASTRAZENECA LP
ETIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~DURANEST~ASTRAZENECA~0.5%~N~017751
~003~~Approved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA LP
ETIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~DURANEST~ASTRAZENECA~1%~N~017751~0
EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~DURANEST~D
ENTSPLY PHARM~0.005MG/ML;1.5%~N~021384~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~DENTSPLY PHARMACEUTICAL
ETHACRYNATE SODIUM~INJECTABLE;INJECTION~EDECRIN~ATON~EQ 50MG BASE/VIAL~N~016093~
001~~Approved Prior to Jan 1, 1982~Yes~RX~ATON PHARMA INC
ALPROSTADIL~INJECTABLE;INJECTION~EDEX~AUXILIUM PHARMS LLC~0.005MG/VIAL~N~020649~
001~~Jun 12, 1997~No~DISCN~AUXILIUM PHARMACEUTICALS LLC
ALPROSTADIL~INJECTABLE;INJECTION~EDEX~AUXILIUM PHARMS LLC~0.01MG/VIAL~N~020649~0
02~AP~Jun 12, 1997~No~RX~AUXILIUM PHARMACEUTICALS LLC
05~~Jul 30, 1998~Yes~RX~AUXILIUM PHARMACEUTICALS LLC
03~AP~Jun 12, 1997~No~RX~AUXILIUM PHARMACEUTICALS LLC
04~AP~Jun 12, 1997~Yes~RX~AUXILIUM PHARMACEUTICALS LLC
EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~EDROPHONIUM CHLORIDE~HOSPIRA~10MG/ML~A
~040131~001~~Feb 24, 1998~No~DISCN~HOSPIRA WORLDWIDE, INC
EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~EDROPHONIUM CHLORIDE~WATSON LABS~10MG/
ML~A~040044~001~~Mar 20, 1996~No~DISCN~WATSON LABORATORIES INC
EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~EDROPHONIUM CHLORIDE PRESERVATIVE FREE
~WATSON LABS~10MG/ML~A~040043~001~~Mar 20, 1996~No~DISCN~WATSON LABORATORIES INC
AMITRIPTYLINE HYDROCHLORIDE~INJECTABLE;INJECTION~ELAVIL~ASTRAZENECA~10MG/ML~N~01
2704~001~~Approved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~ELLENCE~PFIZER INC~200MG/100ML (2M
G/ML)~N~050778~001~AP~Sep 15, 1999~Yes~RX~PFIZER INC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~ELLENCE~PFIZER INC~50MG/25ML (2MG/
ML)~N~050778~002~AP~Sep 15, 1999~No~RX~PFIZER INC
DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE~INJECTABLE;I
NJECTION~EMBOLEX~NOVARTIS~0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML~N~018885~00
1~~Nov 30, 1984~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE~INJECTABLE;I
NJECTION~EMBOLEX~NOVARTIS~0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML~N~018885~00
2~~Nov 30, 1984~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
BENZQUINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~EMETE-CON~PFIZER~EQ 50MG BASE/V
IAL~N~016820~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER INC
ENALAPRILAT~INJECTABLE;INJECTION~ENALAPRILAT~BEDFORD~1.25MG/ML~A~075634~001~AP~A
ug 22, 2000~Yes~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
ENALAPRILAT~INJECTABLE;INJECTION~ENALAPRILAT~HIKMA FARMACEUTICA~1.25MG/ML~A~0786
87~001~AP~Dec 23, 2008~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
ENALAPRILAT~INJECTABLE;INJECTION~ENALAPRILAT~HOSPIRA~1.25MG/ML~A~075456~001~~Aug
ENALAPRILAT~INJECTABLE;INJECTION~ENALAPRILAT~HOSPIRA~1.25MG/ML~A~075458~001~AP~A
ug 22, 2000~Yes~RX~HOSPIRA INC
ENALAPRILAT~INJECTABLE;INJECTION~ENALAPRILAT~HOSPIRA~1.25MG/ML~A~075571~001~~Aug
ENALAPRILAT~INJECTABLE;INJECTION~ENALAPRILAT~TEVA PHARMS USA~1.25MG/ML~A~075578~

001~AP~Aug 22, 2000~No~RX~TEVA PHARMACEUTICALS USA
EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~ENLON~MYLAN INSTITUTIONAL~10MG/ML~A~08
8873~001~AP~Aug 6, 1985~No~RX~MYLAN INSTITUTIONAL LLC
ATROPINE SULFATE; EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~ENLON-PLUS~MYLAN INS
TITUTIONAL~0.14MG/ML;10MG/ML~N~019677~001~~Nov 6, 1991~No~DISCN~MYLAN INSTITUTIO
NAL LLC
ATROPINE SULFATE; EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~ENLON-PLUS~MYLAN INS
TITUTIONAL~0.14MG/ML;10MG/ML~N~019678~001~~Nov 6, 1991~Yes~RX~MYLAN INSTITUTIONA
L LLC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~ACTAVIS T
OTOWA~10MG/5ML (2MG/ML)~A~065445~001~AP~Sep 18, 2008~No~RX~ACTAVIS TOTOWA LLC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~AKORN INC
~50MG/25ML (2MG/ML)~A~090163~001~AP~Jun 24, 2009~No~RX~AKORN INC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~CIPLA LTD
~50MG/25ML (2MG/ML)~A~065361~001~AP~Oct 22, 2007~No~RX~CIPLA LTD
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~CIPLA LTD
~200MG/100ML (2MG/ML)~A~065361~002~AP~Oct 22, 2007~No~RX~CIPLA LTD
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~EBEWE PHA
RMA~50MG/25ML (2MG/ML)~A~065339~001~~Dec 22, 2009~No~DISCN~EBEWE PHARMA GES MBH
NFG KG
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~EBEWE PHA
RMA~200MG/100ML (2MG/ML)~A~065339~002~~Dec 22, 2009~No~DISCN~EBEWE PHARMA GES MB
H NFG KG
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~EUROHLTH
INTL SARL~50MG/25ML (2MG/ML)~A~065289~001~AP~Jun 27, 2007~No~RX~EUROHEALTH INTER
NATIONAL SARL
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~EUROHLTH
INTL SARL~200MG/100ML (2MG/ML)~A~065289~002~AP~Jun 27, 2007~No~RX~EUROHEALTH INT
ERNATIONAL SARL
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~FRESENIUS
KABI ONCOL~200MG/100ML (2MG/ML)~A~065411~001~AP~Aug 20, 2007~No~RX~FRESENIUS KA
BI ONCOLOGY PLC
KABI ONCOL~50MG/25ML (2MG/ML)~A~065411~002~AP~Aug 20, 2007~No~RX~FRESENIUS KABI
ONCOLOGY PLC
KABI USA~10MG/5ML (2MG/ML)~A~065408~001~AP~Oct 15, 2007~No~RX~FRESENIUS KABI US
A LLC
KABI USA~50MG/25ML (2MG/ML)~A~065408~002~AP~Oct 15, 2007~No~RX~FRESENIUS KABI U
SA LLC
KABI USA~150MG/75ML (2MG/ML)~A~065408~003~AP~Oct 15, 2007~No~RX~FRESENIUS KABI
USA LLC
KABI USA~200MG/100ML (2MG/ML)~A~065408~004~AP~Oct 15, 2007~No~RX~FRESENIUS KABI
USA LLC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~HISUN PHA
RM HANGZHOU~50MG/25ML (2MG/ML)~A~090075~001~AP~Mar 25, 2010~No~RX~HISUN PHARMACE
UTICAL (HANGZHOU) CO LTD
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~HISUN PHA
RM HANGZHOU~200MG/100ML (2MG/ML)~A~090075~002~AP~Mar 25, 2010~No~RX~HISUN PHARMA
CEUTICAL (HANGZHOU) CO LTD
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~HOSPIRA~1
0MG/5ML (2MG/ML)~A~065343~001~AP~Apr 19, 2007~No~RX~HOSPIRA INC

0MG/25ML (2MG/ML)~A~065343~002~~Apr 19, 2007~No~DISCN~HOSPIRA INC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~MUSTAFA N
EVSAT~50MG/25ML (2MG/ML)~A~090266~001~~Apr 15, 2011~No~DISCN~MUSTAFA NEVSAT ILAC
SANAYII AS
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~MUSTAFA N
EVSAT~200MG/100ML (2MG/ML)~A~090266~002~~Apr 15, 2011~No~DISCN~MUSTAFA NEVSAT IL
AC SANAYII AS
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~MYLAN INS
TITUTIONAL~50MG/25ML (2MG/ML)~A~065371~001~~Nov 28, 2007~No~DISCN~MYLAN INSTITUT
IONAL LLC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~MYLAN INS
TITUTIONAL~200MG/100ML (2MG/ML)~A~065371~002~~Nov 28, 2007~No~DISCN~MYLAN INSTIT
UTIONAL LLC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~ONCO THER
APIES LTD~50MG/25ML (2MG/ML)~A~091599~001~AP~Mar 12, 2012~No~RX~ONCO THERAPIES L
TD
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~ONCO THER
APIES LTD~200MG/100ML (2MG/ML)~A~091599~002~AP~Mar 12, 2012~No~RX~ONCO THERAPIES
LTD
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~TEVA PHAR
MS USA~50MG/25ML (2MG/ML)~A~065331~001~AP~Aug 9, 2007~No~RX~TEVA PHARMACEUTICALS
USA
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~EPIRUBICIN HYDROCHLORIDE~TEVA PHAR
MS USA~200MG/100ML (2MG/ML)~A~065331~002~AP~Aug 9, 2007~No~RX~TEVA PHARMACEUTICA
LS USA
EPOPROSTENOL SODIUM~INJECTABLE;INJECTION~EPOPROSTENOL SODIUM~TEVA PHARMS USA~EQ
0.5MG BASE/VIAL~A~078396~001~AP~Apr 23, 2008~No~RX~TEVA PHARMACEUTICALS USA
EPOPROSTENOL SODIUM~INJECTABLE;INJECTION~EPOPROSTENOL SODIUM~TEVA PHARMS USA~EQ
1.5MG BASE/VIAL~A~078396~002~AP~Apr 23, 2008~No~RX~TEVA PHARMACEUTICALS USA
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROCIN~ABBOTT~EQ 1GM BASE/VIA
L~A~062586~002~~Jan 4, 1988~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS
DIV
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROCIN~ABBOTT~EQ 500MG BASE/V
IAL~A~062586~001~~Jan 4, 1988~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUC
TS DIV
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROCIN~HOSPIRA~EQ 1GM BASE/VI
AL~A~062638~002~~Oct 31, 1986~Yes~RX~HOSPIRA INC
AL~N~050182~003~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
AL~N~050609~002~~Sep 24, 1986~No~DISCN~HOSPIRA INC
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROCIN~HOSPIRA~EQ 500MG BASE/
VIAL~A~062638~001~AP~Oct 31, 1986~No~RX~HOSPIRA INC
VIAL~N~050182~002~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
VIAL~N~050609~001~AP~Sep 24, 1986~Yes~RX~HOSPIRA INC
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROMYCIN~ELKINS SINN~EQ 1GM B
ASE/VIAL~A~062563~002~~Mar 28, 1985~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROMYCIN~ELKINS SINN~EQ 500MG
BASE/VIAL~A~062563~001~~Mar 28, 1985~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROMYCIN LACTOBIONATE~ABRAXIS
PHARM~EQ 1GM BASE/VIAL~A~062604~002~~Nov 24, 1986~No~DISCN~ABRAXIS PHARMACEUTIC
AL PRODUCTS
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROMYCIN LACTOBIONATE~ABRAXIS
PHARM~EQ 500MG BASE/VIAL~A~062604~001~~Nov 24, 1986~No~DISCN~ABRAXIS PHARMACEUT

ICAL PRODUCTS
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROMYCIN LACTOBIONATE~BAXTER
HLTHCARE~EQ 1GM BASE/VIAL~A~062993~002~~May 9, 1989~No~DISCN~BAXTER HEALTHCARE C
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROMYCIN LACTOBIONATE~BAXTER
HLTHCARE~EQ 500MG BASE/VIAL~A~062993~001~~May 9, 1989~No~DISCN~BAXTER HEALTHCARE
CORP ANESTHESIA AND CRITICAL CARE
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROMYCIN LACTOBIONATE~TEVA PA
RENTERAL~EQ 1GM BASE/VIAL~A~063253~002~~Jul 30, 1993~No~DISCN~TEVA PARENTERAL ME
DICINES INC
ERYTHROMYCIN LACTOBIONATE~INJECTABLE;INJECTION~ERYTHROMYCIN LACTOBIONATE~TEVA PA
RENTERAL~EQ 500MG BASE/VIAL~A~063253~001~~Jul 30, 1993~No~DISCN~TEVA PARENTERAL
MEDICINES INC
ESMOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~ESMOLOL HYDROCHLORIDE~EUROHLTH INTL S
ARL~10MG/ML~A~076323~001~AP~Aug 10, 2004~No~RX~EUROHEALTH INTERNATIONAL SARL
ESMOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~ESMOLOL HYDROCHLORIDE~FRESENIUS KABI
USA~10MG/ML~A~076573~001~AP~May 2, 2005~No~RX~FRESENIUS KABI USA LLC
ESMOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~ESMOLOL HYDROCHLORIDE~LUITPOLD~10MG/M
L~A~201126~001~AP~Feb 20, 2015~No~RX~LUITPOLD PHARMACEUTICALS INC
ESMOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~ESMOLOL HYDROCHLORIDE~MYLAN INSTITUTI
ONAL~10MG/ML~A~076474~001~AP~May 2, 2005~No~RX~MYLAN INSTITUTIONAL LLC
ESTRADIOL CYPIONATE~INJECTABLE;INJECTION~ESTRADIOL CYPIONATE~WATSON LABS~5MG/ML~
A~085620~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
ESTRADIOL VALERATE~INJECTABLE;INJECTION~ESTRADIOL VALERATE~LUITPOLD~20MG/ML~A~09
0920~001~AO~Jan 19, 2010~No~RX~LUITPOLD PHARMACEUTICALS INC
ESTRADIOL VALERATE~INJECTABLE;INJECTION~ESTRADIOL VALERATE~LUITPOLD~40MG/ML~A~09
0920~002~AO~Jan 19, 2010~No~RX~LUITPOLD PHARMACEUTICALS INC
ESTRADIOL VALERATE~INJECTABLE;INJECTION~ESTRADIOL VALERATE~SANDOZ~10MG/ML~A~0406
28~001~~Oct 4, 2007~No~DISCN~SANDOZ CANADA INC
ESTRADIOL VALERATE~INJECTABLE;INJECTION~ESTRADIOL VALERATE~WATSON LABS~10MG/ML~A
ESTRADIOL VALERATE~INJECTABLE;INJECTION~ESTRADIOL VALERATE~WATSON LABS~40MG/ML~A
ESTRADIOL VALERATE~INJECTABLE;INJECTION~ESTRADIOL VALERATE~WATSON LABS INC~20MG/
ML~A~083547~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
POLYESTRADIOL PHOSPHATE~INJECTABLE;INJECTION~ESTRADURIN~WYETH AYERST~40MG/AMP~N~
ESTRONE~INJECTABLE;INJECTION~ESTROGENIC SUBSTANCE~WYETH AYERST~2MG/ML~A~083488~0
ESTRONE~INJECTABLE;INJECTION~ESTRONE~WATSON LABS~2MG/ML~A~083397~001~~Approved P
rior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
ESTRONE~INJECTABLE;INJECTION~ESTRONE~WATSON LABS~5MG/ML~A~085239~001~~Approved P
ETHANOLAMINE OLEATE~INJECTABLE;INJECTION~ETHAMOLIN~QOL MEDCL~50MG/ML~N~019357~00
1~~Dec 22, 1988~Yes~RX~QOL MEDICAL LLC
AMIFOSTINE~INJECTABLE;INJECTION~ETHYOL~CLINIGEN HLTHCARE~375MG/VIAL~N~020221~002
~~Sep 10, 1999~No~DISCN~CLINIGEN HEALTHCARE LTD
AMIFOSTINE~INJECTABLE;INJECTION~ETHYOL~CLINIGEN HLTHCARE~500MG/VIAL~N~020221~001
~AP~Dec 8, 1995~Yes~RX~CLINIGEN HEALTHCARE LTD
ETOMIDATE~INJECTABLE;INJECTION~ETOMIDATE~AGILA SPECLTS~2MG/ML~A~078289~001~AP~Ja
n 2, 2009~No~RX~AGILA SPECIALTIES PRIVATE LTD
ETOMIDATE~INJECTABLE;INJECTION~ETOMIDATE~BEDFORD~2MG/ML~A~074593~001~AP~Nov 4, 1
996~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
ETOMIDATE~INJECTABLE;INJECTION~ETOMIDATE~EMCURE PHARMS LTD~2MG/ML~A~204618~001~A
P~Aug 13, 2014~No~RX~EMCURE PHARMACEUTICALS LTD
ETOMIDATE~INJECTABLE;INJECTION~ETOMIDATE~LUITPOLD~2MG/ML~A~078867~001~AP~Dec 22,
2009~No~RX~LUITPOLD PHARMACEUTICALS INC
ETOMIDATE~INJECTABLE;INJECTION~ETOMIDATE~PAR STERILE PRODUCTS~2MG/ML~A~091297~00
1~AP~Jun 20, 2012~No~RX~PAR STERILE PRODUCTS LLC
ETOMIDATE~INJECTABLE;INJECTION~ETOMIDATE~ZYDUS PHARMS USA INC~2MG/ML~A~202360~00
1~AP~Jul 18, 2014~No~RX~ZYDUS PHARMACEUTICALS USA INC
ETOPOSIDE PHOSPHATE~INJECTABLE;INJECTION~ETOPOPHOS PRESERVATIVE FREE~BRISTOL MYE
RS SQUIBB~EQ 1GM BASE/VIAL~N~020906~002~~Feb 27, 1998~No~DISCN~BRISTOL MYERS SQU
IBB
RS SQUIBB~EQ 100MG BASE/VIAL~N~020457~001~~May 17, 1996~Yes~RX~BRISTOL MYERS SQU
IBB CO PHARMACEUTICAL RESEARCH INSTITUTE
RS SQUIBB~EQ 500MG BASE/VIAL~N~020906~001~~Feb 27, 1998~No~DISCN~BRISTOL MYERS S
QUIBB
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~ACCORD HLTHCARE~20MG/ML~A~074513~001~AP
~Mar 14, 1996~No~RX~ACCORD HEALTHCARE INC
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~EUROHLTH INTL SARL~20MG/ML~A~074290~001
~AP~Jul 17, 1995~No~RX~EUROHEALTH INTERNATIONAL SARL
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~FRESENIUS KABI USA~20MG/ML~A~074983~001
~AP~Sep 30, 1998~Yes~RX~FRESENIUS KABI USA LLC
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~HOSPIRA~20MG/ML~A~074320~001~~Aug 30, 1
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~HOSPIRA~20MG/ML~A~074351~001~~Aug 30, 1
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~PHARMACHEMIE BV~20MG/ML~A~074227~001~~F
eb 22, 1996~No~DISCN~PHARMACHEMIE BV
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~PIERRE FABRE~20MG/ML~A~074813~001~~Jul
9, 1997~No~DISCN~PIERRE FABRE MEDICAMENT
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~TEVA PARENTERAL~20MG/ML~A~074510~001~~J
un 29, 1995~No~DISCN~TEVA PARENTERAL MEDICINES INC
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~TEVA PHARMS USA~20MG/ML~A~074284~001~~F
eb 10, 1994~No~DISCN~TEVA PHARMACEUTICALS USA
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~TEVA PHARMS USA~20MG/ML~A~074529~001~AP
~Jul 24, 1996~No~RX~TEVA PHARMACEUTICALS USA
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~WATSON LABS~20MG/ML~A~074228~001~~Oct 1
ETOPOSIDE~INJECTABLE;INJECTION~ETOPOSIDE~WATSON LABS INC~20MG/ML~A~074968~001~~J
an 9, 1998~No~DISCN~WATSON LABORATORIES INC
EVANS BLUE~INJECTABLE;INJECTION~EVANS BLUE~PARKE DAVIS~0.5% **Federal Register d
cy reasons**~N~008041~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DI
V WARNER LAMBERT CO
GONADORELIN HYDROCHLORIDE~INJECTABLE;INJECTION~FACTREL~HIKMA (MAPLE)~EQ 0.1MG BA
SE/VIAL~N~018123~001~~Sep 30, 1982~No~DISCN~HIKMA (MAPLE) LTD
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~AGILA SPECLTS~10MG/ML~A~078641~001~AP
~Jun 25, 2008~No~RX~AGILA SPECIALTIES PRIVATE LTD
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~APOTEX INC~10MG/ML~A~075942~001~~Aug
2, 2002~No~DISCN~APOTEX INC
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~APOTHECON~10MG/ML~A~075707~001~~Apr 1
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~BEDFORD~10MG/ML~A~075651~001~AP~Apr 1
6, 2001~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~BEDFORD~10MG/ML~A~075684~001~AP~Apr 1
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~FRESENIUS KABI USA~10MG/ML~A~075709~0
01~AP~Apr 16, 2001~No~RX~FRESENIUS KABI USA LLC

FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~HIKMA MAPLE ~10MG/ML~A~075488~001~AP~
Apr 16, 2001~Yes~RX~HIKMA MAPLE LTD
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~HIKMA MAPLE ~10MG/ML~A~075799~001~~Ap
r 30, 2002~No~DISCN~HIKMA MAPLE LTD
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~HOSPIRA~10MG/ML~A~075705~001~~Apr 16,
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~HOSPIRA~10MG/ML~A~075870~001~~Nov 23,
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE~HOSPIRA~10MG/ML~A~075905~001~~Nov 23,
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~AGILA SPECLTS~10MG/
ML~A~078642~001~AP~Jun 25, 2008~No~RX~AGILA SPECIALTIES PRIVATE LTD
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~APOTEX INC~10MG/ML~
A~076324~001~~Nov 27, 2002~No~DISCN~APOTEX INC
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~APOTHECON~10MG/ML~A
~075708~001~~Apr 16, 2001~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~BEDFORD~10MG/ML~A~0
75622~001~AP~Apr 16, 2001~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES
INC
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~BEDFORD LABS~10MG/M
L~A~075825~001~AP~Apr 17, 2001~No~RX~BEDFORD LABORATORIES
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~FRESENIUS KABI USA~
10MG/ML~A~075813~001~AP~Apr 16, 2001~No~RX~FRESENIUS KABI USA LLC
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~HIKMA MAPLE ~10MG/M
L~A~075486~001~AP~Apr 16, 2001~Yes~RX~HIKMA MAPLE LTD
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~HIKMA MAPLE ~10MG/M
L~A~075789~001~~Apr 30, 2002~No~DISCN~HIKMA MAPLE LTD
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE~HOSPIRA~10MG/ML~A~0
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)~APO
TEX INC~10MG/ML~A~076322~001~~Nov 27, 2002~No~DISCN~APOTEX INC
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINE
R~ABBVIE~0.4MG/ML~A~075729~001~~Dec 17, 2001~No~DISCN~ABBVIE INC
FAMOTIDINE~INJECTABLE;INJECTION~FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINE
R~BAXTER HLTHCARE~0.4MG/ML~A~075591~001~AP~May 10, 2001~Yes~RX~BAXTER HEALTHCARE
CORP
FENOLDOPAM MESYLATE~INJECTABLE;INJECTION~FENOLDOPAM MESYLATE~EUROHLTH INTL SARL~
EQ 10MG BASE/ML~A~076582~001~AP~Oct 12, 2004~No~RX~EUROHEALTH INTERNATIONAL SARL
FENOLDOPAM MESYLATE~INJECTABLE;INJECTION~FENOLDOPAM MESYLATE~LUITPOLD~EQ 10MG BA
SE/ML~A~076656~001~~Dec 1, 2003~No~DISCN~LUITPOLD PHARMACEUTICALS INC
FENOLDOPAM MESYLATE~INJECTABLE;INJECTION~FENOLDOPAM MESYLATE~SANDOZ~EQ 10MG BASE
/ML~A~077155~001~AP~Feb 15, 2005~No~RX~SANDOZ CANADA INC
FENOLDOPAM MESYLATE~INJECTABLE;INJECTION~FENOLDOPAM MESYLATE~TEVA PARENTERAL~EQ
10MG BASE/ML~A~077826~001~~Mar 7, 2007~No~DISCN~TEVA PARENTERAL MEDICINES INC
FENTANYL CITRATE~INJECTABLE;INJECTION~FENTANYL CITRATE~ABBOTT~EQ 0.05MG BASE/ML~
A~070636~001~~Apr 30, 1990~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
FENTANYL CITRATE~INJECTABLE;INJECTION~FENTANYL CITRATE~ABBOTT~EQ 0.05MG BASE/ML~
A~070637~001~~Apr 30, 1990~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
FENTANYL CITRATE~INJECTABLE;INJECTION~FENTANYL CITRATE~HOSPIRA~EQ 0.05MG BASE/ML
~N~019115~001~AP~Jan 12, 1985~No~RX~HOSPIRA INC
FENTANYL CITRATE~INJECTABLE;INJECTION~FENTANYL CITRATE~WATSON LABS~EQ 0.05MG BAS
E/ML~A~073488~001~~Jun 30, 1992~No~DISCN~WATSON LABORATORIES INC
DROPERIDOL; FENTANYL CITRATE~INJECTABLE;INJECTION~FENTANYL CITRATE AND DROPERIDO
L~ASTRAZENECA~2.5MG/ML;EQ 0.05MG BASE/ML~A~072026~001~~Apr 13, 1989~No~DISCN~AST
RAZENECA LP
RAZENECA LP

RAZENECA LP
L~HOSPIRA~2.5MG/ML;EQ 0.05MG BASE/ML~A~071982~001~~May 4, 1988~No~DISCN~HOSPIRA
INC
FENTANYL CITRATE~INJECTABLE;INJECTION~FENTANYL CITRATE PRESERVATIVE FREE~EUROHLT
H INTL SARL~EQ 0.05MG BASE/ML~N~019101~001~AP~Jul 11, 1984~Yes~RX~EUROHEALTH INT
ERNATIONAL SARL
FENTANYL CITRATE~INJECTABLE;INJECTION~FENTANYL CITRATE PRESERVATIVE FREE~HOSPIRA
~EQ 0.05MG BASE/ML~A~072786~001~AP~Sep 24, 1991~No~RX~HOSPIRA INC
FENTANYL CITRATE~INJECTABLE;INJECTION~FENTANYL CITRATE PRESERVATIVE FREE~WATSON
LABS INC~EQ 0.05MG BASE/ML~A~074917~001~~Feb 3, 1998~No~DISCN~WATSON LABORATORIE
S INC
FERUMOXIDES~INJECTABLE;INJECTION~FERIDEX I.V.~AMAG PHARMS INC~EQ 11.2MG IRON/ML~
N~020416~001~~Aug 30, 1996~No~DISCN~AMAG PHARMACEUTICALS INC
SODIUM FERRIC GLUCONATE COMPLEX~INJECTABLE;INJECTION~FERRLECIT~SANOFI AVENTIS US
~62.5MG/5ML~N~020955~001~AB~Feb 18, 1999~Yes~RX~SANOFI AVENTIS US LLC
FERROUS CITRATE, FE-59~INJECTABLE;INJECTION~FERROUS CITRATE FE 59~MALLINCKRODT~2
5uCi/ML~N~016729~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT INC
METRONIDAZOLE HYDROCHLORIDE~INJECTABLE;INJECTION~FLAGYL I.V.~PFIZER~EQ 500MG BAS
E/VIAL~N~018353~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER INC
METRONIDAZOLE~INJECTABLE;INJECTION~FLAGYL I.V. RTU IN PLASTIC CONTAINER~BAXTER H
LTHCARE~500MG/100ML~N~018657~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~BAXTER
HEALTHCARE CORP
METRONIDAZOLE~INJECTABLE;INJECTION~FLAGYL I.V. RTU IN PLASTIC CONTAINER~PFIZER~5
00MG/100ML~N~018353~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~PFIZER INC
GALLAMINE TRIETHIODIDE~INJECTABLE;INJECTION~FLAXEDIL~DAVIS AND GECK~20MG/ML~N~00
7842~001~~Approved Prior to Jan 1, 1982~No~DISCN~DAVIS AND GECK DIV AMERICAN CYA
NAMID CO
GALLAMINE TRIETHIODIDE~INJECTABLE;INJECTION~FLAXEDIL~DAVIS AND GECK~100MG/ML~N~0
07842~002~~Approved Prior to Jan 1, 1982~No~DISCN~DAVIS AND GECK DIV AMERICAN CY
ANAMID CO
EPOPROSTENOL SODIUM~INJECTABLE;INJECTION~FLOLAN~GLAXOSMITHKLINE LLC~EQ 0.5MG BAS
E/VIAL~N~020444~001~AP~Sep 20, 1995~Yes~RX~GLAXOSMITHKLINE LLC
EPOPROSTENOL SODIUM~INJECTABLE;INJECTION~FLOLAN~GLAXOSMITHKLINE LLC~EQ 1.5MG BAS
E/VIAL~N~020444~002~AP~Sep 20, 1995~Yes~RX~GLAXOSMITHKLINE LLC
OFLOXACIN~INJECTABLE;INJECTION~FLOXIN~ORTHO MCNEIL PHARM~20MG/ML~N~020087~002~~M
ar 31, 1992~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
OFLOXACIN~INJECTABLE;INJECTION~FLOXIN~ORTHO MCNEIL PHARM~40MG/ML~N~020087~003~~M
ar 31, 1992~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
OFLOXACIN~INJECTABLE;INJECTION~FLOXIN IN DEXTROSE 5%~ORTHO MCNEIL PHARM~400MG/10
0ML~N~020087~001~~Mar 31, 1992~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
OFLOXACIN~INJECTABLE;INJECTION~FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER~ORTHO
MCNEIL PHARM~4MG/ML~N~020087~004~~Mar 31, 1992~No~DISCN~ORTHO MCNEIL PHARMACEUTI
CAL INC
OFLOXACIN~INJECTABLE;INJECTION~FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER~ORTHO
MCNEIL PHARM~400MG/100ML~N~020087~005~~Mar 31, 1992~No~DISCN~ORTHO MCNEIL PHARMA
CEUTICAL INC
FLOXURIDINE~INJECTABLE;INJECTION~FLOXURIDINE~EUROHLTH INTL SARL~500MG/VIAL~A~075
387~001~AP~Apr 16, 2000~Yes~RX~EUROHEALTH INTERNATIONAL SARL
FLOXURIDINE~INJECTABLE;INJECTION~FLOXURIDINE~FRESENIUS KABI USA~500MG/VIAL~A~075
837~001~AP~Feb 22, 2001~No~RX~FRESENIUS KABI USA LLC
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC
CONTAINER~ACS DOBFAR INFO SA~200MG/100ML (2MG/ML)~A~079104~001~AP~Jul 30, 2009~N
o~RX~ACS DOBFAR INFO SA
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC
CONTAINER~ACS DOBFAR INFO SA~400MG/200ML (2MG/ML)~A~079104~002~AP~Jul 30, 2009~N
o~RX~ACS DOBFAR INFO SA
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
~AGILA SPECLTS~200MG/100ML (2MG/ML)~A~076888~001~~Mar 25, 2005~No~DISCN~AGILA SP

~AGILA SPECLTS~400MG/200ML (2MG/ML)~A~076888~002~~Mar 25, 2005~No~DISCN~AGILA SP
~CLARIS LIFESCIENCES~200MG/100ML (2MG/ML)~A~077988~001~AP~May 26, 2010~No~RX~CLA
RIS LIFESCIENCES LTD
~CLARIS LIFESCIENCES~400MG/200ML (2MG/ML)~A~077988~002~AP~May 26, 2010~No~RX~CLA
RIS LIFESCIENCES LTD
~HIKMA FARMACEUTICA~200MG/100ML (2MG/ML)~A~078764~001~AP~Jan 30, 2012~No~RX~HIKM
A FARMACEUTICA (PORTUGAL) SA
~HIKMA FARMACEUTICA~400MG/200ML (2MG/ML)~A~078764~002~AP~Jan 30, 2012~No~RX~HIKM
A FARMACEUTICA (PORTUGAL) SA
~HOSPIRA~200MG/100ML (2MG/ML)~A~076304~001~AP~Jul 29, 2004~No~RX~HOSPIRA INC
~HOSPIRA~400MG/200ML (2MG/ML)~A~076304~002~AP~Jul 29, 2004~No~RX~HOSPIRA INC
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9%~BEDFORD~100
MG/50ML (2MG/ML)~A~076087~002~~Sep 26, 2008~No~RX~BEDFORD LABORATORIES DIV BEN V
ENUE LABORATORIES INC
MG/100ML (2MG/ML)~A~076087~001~AP~Jul 29, 2004~No~RX~BEDFORD LABORATORIES DIV BE
N VENUE LABORATORIES INC
MG/200ML (2MG/ML)~A~076087~003~AP~Jul 29, 2004~No~RX~BEDFORD LABORATORIES DIV BE
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9%~CLARIS LIFE
SCIENCES~200MG/100ML (2MG/ML)~A~077947~001~AP~May 26, 2010~No~RX~CLARIS LIFESCIE
NCES LTD
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9%~CLARIS LIFE
SCIENCES~400MG/200ML (2MG/ML)~A~077947~002~AP~May 26, 2010~No~RX~CLARIS LIFESCIE
NCES LTD
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9%~FRESENIUS K
ABI USA~200MG/100ML (2MG/ML)~A~076145~001~AP~Jul 29, 2004~No~RX~FRESENIUS KABI U
SA LLC
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9%~FRESENIUS K
ABI USA~400MG/200ML (2MG/ML)~A~076145~002~AP~Jul 29, 2004~No~RX~FRESENIUS KABI U
SA LLC
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9%~HIKMA FARMA
CEUTICA~200MG/100ML (2MG/ML)~A~076736~001~AP~Aug 23, 2005~No~RX~HIKMA FARMACEUTI
CA PORTUGAL LDA
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9%~TEVA PHARMS
USA~200MG/100ML (2MG/ML)~A~076653~001~AP~Jul 29, 2004~No~RX~TEVA PHARMACEUTICAL
S USA
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9%~TEVA PHARMS
USA~400MG/200ML (2MG/ML)~A~076653~002~AP~Jul 29, 2004~No~RX~TEVA PHARMACEUTICAL
S USA
FLUCONAZOLE~INJECTABLE;INJECTION~FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC
CONTAINER~AGILA SPECLTS~200MG/100ML (2MG/ML)~A~076889~001~~Mar 25, 2005~No~DISCN
~AGILA SPECIALTIES PRIVATE LTD
CONTAINER~AGILA SPECLTS~400MG/200ML (2MG/ML)~A~076889~002~~Mar 25, 2005~No~DISCN
~AGILA SPECIALTIES PRIVATE LTD
CONTAINER~BAXTER HLTHCARE~200MG/100ML (2MG/ML)~A~076766~001~AP~Jul 29, 2004~No~R
X~BAXTER HEALTHCARE CORP
CONTAINER~BAXTER HLTHCARE~400MG/200ML (2MG/ML)~A~076766~002~AP~Jul 29, 2004~No~R

X~BAXTER HEALTHCARE CORP
CONTAINER~BEDFORD LABS~200MG/100ML (2MG/ML)~A~078107~001~AP~Jul 30, 2008~No~RX~B
EDFORD LABORATORIES
CONTAINER~BEDFORD LABS~400MG/200ML (2MG/ML)~A~078107~002~AP~Jul 30, 2008~No~RX~B
EDFORD LABORATORIES
CONTAINER~CLARIS LIFESCIENCES~200MG/100ML (2MG/ML)~A~077909~001~AP~May 26, 2010~
No~RX~CLARIS LIFESCIENCES LTD
CONTAINER~CLARIS LIFESCIENCES~400MG/200ML (2MG/ML)~A~077909~002~AP~May 26, 2010~
No~RX~CLARIS LIFESCIENCES LTD
CONTAINER~HIKMA FARMACEUTICA~200MG/100ML (2MG/ML)~A~078698~001~AP~Jan 30, 2012~N
o~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
CONTAINER~HIKMA FARMACEUTICA~400MG/200ML (2MG/ML)~A~078698~002~AP~Jan 30, 2012~N
o~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
CONTAINER~HOSPIRA~200MG/100ML (2MG/ML)~A~076303~001~AP~Jul 29, 2004~No~RX~HOSPIR
A INC
CONTAINER~HOSPIRA~200MG/100ML (2MG/ML)~A~076617~001~~Jul 29, 2004~No~DISCN~HOSPI
RA INC
CONTAINER~HOSPIRA~400MG/200ML (2MG/ML)~A~076303~002~AP~Jul 29, 2004~No~RX~HOSPIR
A INC
CONTAINER~HOSPIRA~400MG/200ML (2MG/ML)~A~076617~002~~Jul 29, 2004~No~DISCN~HOSPI
RA INC
CONTAINER~TEVA PHARMS~200MG/100ML (2MG/ML)~A~076837~001~~Jan 13, 2005~No~DISCN~T
CONTAINER~TEVA PHARMS~400MG/200ML (2MG/ML)~A~076837~002~~Jan 13, 2005~No~DISCN~T
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARA~GENZYME CORP~50MG/VIAL~N~0200
38~001~~Apr 18, 1991~No~DISCN~GENZYME CORP
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~ACTAVIS TOTOWA~
50MG/VIAL~A~078610~001~AP~Feb 11, 2009~No~RX~ACTAVIS TOTOWA LLC
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~FRESENIUS KABI
USA~50MG/2ML (25MG/ML)~A~078393~001~AP~Oct 15, 2007~Yes~RX~FRESENIUS KABI USA LL
C
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~FRESENIUS KABI
USA~50MG/VIAL~A~078544~001~AP~Oct 15, 2007~No~RX~FRESENIUS KABI USA LLC
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~HOSPIRA~50MG/VI
AL~A~077790~001~AP~Apr 6, 2007~Yes~RX~HOSPIRA WORLDWIDE, INC
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~MUSTAFA NEVZAT
ILAC~50MG/2ML (25MG/ML)~A~090724~001~AP~Sep 27, 2010~No~RX~MUSTAFA NEVZAT ILAC S
ANAYII AS (MN PHARMACEUTICALS)
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~ONCO THERAPIES
LTD~50MG/2ML (25MG/ML)~A~200647~001~AP~Dec 21, 2011~No~RX~ONCO THERAPIES LTD
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~ONCO THERAPIES
LTD~50MG/VIAL~A~200648~001~AP~Oct 16, 2012~No~RX~ONCO THERAPIES LTD
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~SANDOZ~50MG/2ML
(25MG/ML)~N~022137~001~AP~Sep 21, 2007~Yes~RX~SANDOZ INC
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~TEVA PHARMS USA
~50MG/VIAL~A~076349~001~AP~Aug 28, 2003~No~RX~TEVA PHARMACEUTICALS USA
FLUDARABINE PHOSPHATE~INJECTABLE;INJECTION~FLUDARABINE PHOSPHATE~TEVA PHARMS USA

~50MG/2ML (25MG/ML)~A~076661~001~AP~Apr 28, 2004~No~RX~TEVA PHARMACEUTICALS USA
FLUDEOXYGLUCOSE F-18~INJECTABLE;INJECTION~FLUDEOXYGLUCOSE F 18~DOWNSTATE CLINCL~
4-40mCi/ML **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons**~N~020306~001~~Aug 19, 1994~No~DISCN~
DOWNSTATE CLINICAL PET CENTER
FLUDEOXYGLUCOSE F-18~INJECTABLE;INJECTION~FLUDEOXYGLUCOSE F 18~DOWNSTATE CLINCL~
4-90mCi/ML **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons**~N~020306~002~~Sep 25, 2001~No~DISCN~
DOWNSTATE CLINICAL PET CENTER
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~AGILA SPECLTS~0.5MG/5ML (0.1MG/ML)~A~
078595~001~AP~May 13, 2008~No~RX~AGILA SPECIALTIES PRIVATE LTD
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~AGILA SPECLTS~1MG/10ML (0.1MG/ML)~A~0
78595~002~AP~May 13, 2008~Yes~RX~AGILA SPECIALTIES PRIVATE LTD
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~APOTEX INC~0.5MG/5ML (0.1MG/ML)~A~076
755~002~~Oct 12, 2004~No~DISCN~APOTEX INC
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~APOTEX INC~1MG/10ML (0.1MG/ML)~A~0767
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~BEDFORD LABS~0.5MG/5ML (0.1MG/ML)~A~0
76256~002~AP~Oct 12, 2004~No~RX~BEDFORD LABORATORIES
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~BEDFORD LABS~1MG/10ML (0.1MG/ML)~A~07
6256~001~AP~Oct 12, 2004~No~RX~BEDFORD LABORATORIES
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~FRESENIUS KABI USA~0.5MG/5ML (0.1MG/M
L)~A~076955~002~AP~Oct 12, 2004~No~RX~FRESENIUS KABI USA LLC
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~FRESENIUS KABI USA~1MG/10ML (0.1MG/ML
)~A~076955~001~AP~Oct 12, 2004~No~RX~FRESENIUS KABI USA LLC
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~HIKMA FARMACEUTICA~0.5MG/5ML (0.1MG/M
L)~A~078527~001~AP~Mar 23, 2009~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~HIKMA FARMACEUTICA~1MG/10ML (0.1MG/ML
)~A~078527~002~AP~Mar 23, 2009~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~HIKMA MAPLE ~0.5MG/5ML (0.1MG/ML)~A~0
76787~002~AP~Oct 12, 2004~No~RX~HIKMA MAPLE LTD
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~HIKMA MAPLE ~1MG/10ML (0.1MG/ML)~A~07
6787~001~AP~Oct 12, 2004~No~RX~HIKMA MAPLE LTD
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~SAGENT PHARMS~0.5MG/5ML (0.1MG/ML)~A~
090584~001~AP~Aug 28, 2012~No~RX~SAGENT PHARMACEUTICALS INC
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~SAGENT PHARMS~1MG/10ML (0.1MG/ML)~A~0
90584~002~AP~Aug 28, 2012~No~RX~SAGENT PHARMACEUTICALS INC
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~SANDOZ~0.5MG/5ML (0.1MG/ML)~A~077071~
001~AP~May 3, 2005~No~RX~SANDOZ CANADA INC
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~SANDOZ~1MG/10ML (0.1MG/ML)~A~077071~0
02~AP~May 3, 2005~No~RX~SANDOZ CANADA INC
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~TEVA PHARMS USA~0.5MG/5ML (0.1MG/ML)~
A~076589~002~~Oct 12, 2004~No~DISCN~TEVA PHARMACEUTICALS USA
FLUMAZENIL~INJECTABLE;INJECTION~FLUMAZENIL~TEVA PHARMS USA~1MG/10ML (0.1MG/ML)~A
~076589~001~~Oct 12, 2004~No~DISCN~TEVA PHARMACEUTICALS USA
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ABIC~50MG/ML~A~088929~001~~Mar 4,
1986~No~DISCN~ABIC LTD
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ABRAXIS PHARM~50MG/ML~A~089152~00
1~~Mar 21, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
1~~Mar 12, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ACCORD HLTHCARE~1GM/20ML (50MG/ML
)~A~040743~001~AP~Apr 26, 2007~Yes~RX~ACCORD HEALTHCARE INC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ACCORD HLTHCARE~2.5GM/50ML (50MG/
ML)~A~040798~002~AP~Apr 26, 2007~Yes~RX~ACCORD HEALTHCARE INC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ACCORD HLTHCARE~5GM/100ML (50MG/M
L)~A~040798~001~AP~Apr 26, 2007~Yes~RX~ACCORD HEALTHCARE INC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ACCORD HLTHCARE~500MG/10ML (50MG/

ML)~A~040743~002~AP~Apr 26, 2007~Yes~RX~ACCORD HEALTHCARE INC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~BEDFORD~50MG/ML~A~089508~001~~Jan
26, 1988~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~EBEWE PHARMA~500MG/10ML (50MG/ML)
~A~040772~001~~Aug 11, 2008~No~DISCN~EBEWE PHARMA GES MBH NFG KG
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~FRESENIUS KABI USA~1GM/20ML (50MG
/ML)~A~040279~001~AP~Sep 30, 1998~Yes~RX~FRESENIUS KABI USA LLC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~FRESENIUS KABI USA~2.5GM/50ML (50
MG/ML)~A~040278~001~AP~Sep 30, 1998~Yes~RX~FRESENIUS KABI USA LLC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~FRESENIUS KABI USA~5GM/100ML (50M
G/ML)~A~040278~002~AP~Sep 30, 1998~Yes~RX~FRESENIUS KABI USA LLC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~FRESENIUS KABI USA~50MG/ML~A~0402
91~001~~Mar 24, 1999~No~DISCN~FRESENIUS KABI USA LLC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~FRESENIUS KABI USA~50MG/ML~A~0403
79~001~~Nov 15, 2000~No~DISCN~FRESENIUS KABI USA LLC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~FRESENIUS KABI USA~500MG/10ML (50
MG/ML)~A~040279~002~AP~Sep 30, 1998~Yes~RX~FRESENIUS KABI USA LLC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~MARCHAR~50MG/ML~A~087791~001~~Jan
18, 1983~No~DISCN~MARCHAR LABORATORIES INC LTD
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ONCO THERAPIES LTD~1GM/20ML (50MG
/ML)~A~202668~002~AP~Jul 17, 2012~No~RX~ONCO THERAPIES LTD
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ONCO THERAPIES LTD~2.5GM/50ML (50
MG/ML)~A~202669~001~AP~Jul 17, 2012~No~RX~ONCO THERAPIES LTD
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ONCO THERAPIES LTD~5GM/100ML (50M
G/ML)~A~202669~002~AP~Jul 17, 2012~No~RX~ONCO THERAPIES LTD
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~ONCO THERAPIES LTD~500MG/10ML (50
MG/ML)~A~202668~001~AP~Jul 17, 2012~No~RX~ONCO THERAPIES LTD
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~SANDOZ~2.5GM/50ML (50MG/ML)~A~091
299~001~AP~May 2, 2011~No~RX~SANDOZ INC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~SANDOZ~5GM/100ML (50MG/ML)~A~0912
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~SMITH AND NEPHEW~50MG/ML~A~088766
~001~~Dec 28, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
~001~~Dec 28, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
~001~~Mar 26, 1987~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~SPECTRUM PHARMS~50MG/ML~A~087792~
001~~Oct 13, 1982~No~DISCN~SPECTRUM PHARMACEUTICALS INC
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~TEVA PHARMS USA~2.5GM/50ML (50MG/
ML)~A~040334~001~AP~Feb 25, 2000~Yes~RX~TEVA PHARMACEUTICALS USA
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~TEVA PHARMS USA~5GM/100ML (50MG/M
L)~A~040334~002~AP~Feb 25, 2000~Yes~RX~TEVA PHARMACEUTICALS USA
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~TEVA PHARMS USA~500MG/10ML (50MG/
ML)~A~040333~001~AP~Jan 27, 2000~Yes~RX~TEVA PHARMACEUTICALS USA
FLUOROURACIL~INJECTABLE;INJECTION~FLUOROURACIL~VALEANT~500MG/10ML (50MG/ML)~N~01
TIONAL
FLUPHENAZINE DECANOATE~INJECTABLE;INJECTION~FLUPHENAZINE DECANOATE~AGILA SPECLTS
~25MG/ML~A~075918~001~~Aug 17, 2001~No~DISCN~AGILA SPECIALTIES PRIVATE LTD
FLUPHENAZINE DECANOATE~INJECTABLE;INJECTION~FLUPHENAZINE DECANOATE~EUROHLTH INTL
SARL~25MG/ML~A~074531~001~AO~Aug 30, 1996~No~RX~EUROHEALTH INTERNATIONAL SARL
FLUPHENAZINE DECANOATE~INJECTABLE;INJECTION~FLUPHENAZINE DECANOATE~FRESENIUS KAB
I USA~25MG/ML~A~071413~001~AO~Jul 14, 1987~Yes~RX~FRESENIUS KABI USA LLC
FLUPHENAZINE DECANOATE~INJECTABLE;INJECTION~FLUPHENAZINE DECANOATE~HOSPIRA~25MG/
ML~A~074966~001~~Apr 16, 1998~No~DISCN~HOSPIRA INC
FLUPHENAZINE DECANOATE~INJECTABLE;INJECTION~FLUPHENAZINE DECANOATE~PAR STERILE P
RODUCTS~25MG/ML~A~203732~001~AO~Jul 3, 2014~No~RX~PAR STERILE PRODUCTS LLC
FLUPHENAZINE DECANOATE~INJECTABLE;INJECTION~FLUPHENAZINE DECANOATE~TEVA PARENTER
AL~25MG/ML~A~074795~001~~Sep 10, 1996~No~DISCN~TEVA PARENTERAL MEDICINES INC

FLUPHENAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~FLUPHENAZINE HYDROCHLORIDE~FRESE
NIUS KABI USA~2.5MG/ML~A~089556~001~~Apr 16, 1987~Yes~RX~FRESENIUS KABI USA LLC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~FOLEX~PHARMACIA AND UPJOHN~EQ 25MG BASE
/VIAL~A~087695~001~~Apr 8, 1983~No~DISCN~PHARMACIA AND UPJOHN CO
METHOTREXATE SODIUM~INJECTABLE;INJECTION~FOLEX~PHARMACIA AND UPJOHN~EQ 50MG BASE
/VIAL~A~087695~002~~Apr 8, 1983~No~DISCN~PHARMACIA AND UPJOHN CO
METHOTREXATE SODIUM~INJECTABLE;INJECTION~FOLEX~PHARMACIA AND UPJOHN~EQ 100MG BAS
E/VIAL~A~087695~003~~Apr 8, 1983~No~DISCN~PHARMACIA AND UPJOHN CO
METHOTREXATE SODIUM~INJECTABLE;INJECTION~FOLEX~PHARMACIA AND UPJOHN~EQ 250MG BAS
E/VIAL~A~088954~001~~Oct 24, 1985~No~DISCN~PHARMACIA AND UPJOHN CO
METHOTREXATE SODIUM~INJECTABLE;INJECTION~FOLEX PFS~PHARMACIA AND UPJOHN~EQ 25MG
BASE/ML~A~081242~001~~Aug 23, 1991~No~DISCN~PHARMACIA AND UPJOHN CO
METHOTREXATE SODIUM~INJECTABLE;INJECTION~FOLEX PFS~PHARMACIA AND UPJOHN~EQ 25MG
BASE/ML~A~089180~001~~Jan 3, 1986~No~DISCN~PHARMACIA AND UPJOHN CO
FOLIC ACID~INJECTABLE;INJECTION~FOLIC ACID~BEN VENUE~5MG/ML~A~081066~001~~Dec 29
, 1993~No~DISCN~BEN VENUE LABORATORIES INC
FOLIC ACID~INJECTABLE;INJECTION~FOLIC ACID~FRESENIUS KABI USA~5MG/ML~A~089202~00
1~~Feb 18, 1986~Yes~RX~FRESENIUS KABI USA LLC
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~FOLLUTEIN~BRISTOL MYERS SQUIBB~10,0
00 UNITS/VIAL~N~017056~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS
SQUIBB
FOLIC ACID~INJECTABLE;INJECTION~FOLVITE~HIKMA (MAPLE)~5MG/ML~N~005897~008~~Appro
ved Prior to Jan 1, 1982~No~DISCN~HIKMA (MAPLE) LTD
FOMEPIZOLE~INJECTABLE;INJECTION~FOMEPIZOLE~LUITPOLD~1.5GM/1.5ML (1GM/ML)~A~07836
FOMEPIZOLE~INJECTABLE;INJECTION~FOMEPIZOLE~MYLAN INSTITUTIONAL~1.5GM/1.5ML (1GM/
ML)~A~079033~001~~Apr 7, 2009~No~DISCN~MYLAN INSTITUTIONAL LLC
FOMEPIZOLE~INJECTABLE;INJECTION~FOMEPIZOLE~MYLAN INSTITUTIONAL~1.5GM/1.5ML (1GM/
ML)~A~078639~001~AP~Mar 3, 2008~No~RX~MYLAN INSTITUTIONAL LLC
FOMEPIZOLE~INJECTABLE;INJECTION~FOMEPIZOLE~NAVINTA LLC~1.5GM/1.5ML (1GM/ML)~A~07
8537~001~AP~Mar 6, 2008~No~RX~NAVINTA LLC
CEFTAZIDIME~INJECTABLE;INJECTION~FORTAZ~COVIS INJECTABLES~1GM/VIAL~N~050578~002~
AP~Jul 19, 1985~Yes~RX~COVIS INJECTABLES SARL
CEFTAZIDIME~INJECTABLE;INJECTION~FORTAZ~COVIS INJECTABLES~500MG/VIAL~N~050578~00
1~AP~Jul 19, 1985~Yes~RX~COVIS INJECTABLES SARL
CEFTAZIDIME SODIUM~INJECTABLE;INJECTION~FORTAZ IN PLASTIC CONTAINER~COVIS INJECT
ABLES~EQ 10MG BASE/ML~N~050634~001~~Apr 28, 1989~No~DISCN~COVIS INJECTABLES SARL
ABLES~EQ 20MG BASE/ML~N~050634~002~~Apr 28, 1989~Yes~RX~COVIS INJECTABLES SARL
FOSCARNET SODIUM~INJECTABLE;INJECTION~FOSCARNET SODIUM~HOSPIRA~2.4GM/100ML~A~077
174~001~AP~May 31, 2005~No~RX~HOSPIRA INC
FOSCARNET SODIUM~INJECTABLE;INJECTION~FOSCAVIR~CLINIGEN HLTHCARE~2.4GM/100ML~N~0
20068~001~AP~Sep 27, 1991~Yes~RX~CLINIGEN HEALTHCARE LTD
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~AGILA SPECLTS~EQ 50
MG PHENYTOIN NA/ML~A~078736~001~AP~Jun 8, 2010~No~RX~AGILA SPECIALTIES PRIVATE L
TD
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~AMNEAL PHARMS CO~EQ
50MG PHENYTOIN NA/ML~A~078476~001~AP~Mar 18, 2008~No~RX~AMNEAL PHARMACEUTICALS
CO GMBH
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~APOTEX INC~EQ 50MG
PHENYTOIN NA/ML~A~078126~001~~Aug 6, 2007~No~DISCN~APOTEX INC
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~BEDFORD~EQ 50MG PHE
NYTOIN NA/ML~A~077481~001~AP~Aug 6, 2007~No~RX~BEDFORD LABORATORIES DIV BEN VENU
E LABORATORIES INC
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~FRESENIUS KABI USA~
EQ 50MG PHENYTOIN NA/ML~A~078052~001~AP~Aug 6, 2007~Yes~RX~FRESENIUS KABI USA LL
C
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~HIKMA FARMACEUTICA~
EQ 50MG PHENYTOIN NA/ML~A~078765~001~AP~Dec 2, 2009~No~RX~HIKMA FARMACEUTICA (PO
RTUGAL) SA
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~HIKMA MAPLE ~EQ 50M
G PHENYTOIN NA/ML~A~077989~001~AP~Aug 6, 2007~No~RX~HIKMA MAPLE LTD
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~HOSPIRA~EQ 50MG PHE
NYTOIN NA/ML~A~078158~001~AP~Aug 6, 2007~No~RX~HOSPIRA INC
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~LUITPOLD~EQ 50MG PH
ENYTOIN NA/ML~A~078277~001~AP~Aug 6, 2007~No~RX~LUITPOLD PHARMACEUTICALS INC
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~LUITPOLD~EQ 50MG PH
ENYTOIN NA/ML~A~090099~001~AP~May 13, 2010~No~RX~LUITPOLD PHARMACEUTICALS INC
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~SUN PHARMA GLOBAL~E
Q 50MG PHENYTOIN NA/ML~A~078417~001~AP~Mar 18, 2008~No~RX~SUN PHARMA GLOBAL INC
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~TEVA PHARMS USA~EQ
50MG PHENYTOIN NA/ML~A~076886~001~~Aug 6, 2007~No~DISCN~TEVA PHARMACEUTICALS USA
FOSPHENYTOIN SODIUM~INJECTABLE;INJECTION~FOSPHENYTOIN SODIUM~WOCKHARDT~EQ 50MG P
HENYTOIN NA/ML~A~078137~001~AP~Aug 6, 2007~No~RX~WOCKHARDT LTD
DALTEPARIN SODIUM~INJECTABLE;INJECTION~FRAGMIN~EISAI INC~7,500 IU/0.75ML~N~02028
7~008~~Apr 4, 2002~No~DISCN~EISAI INC
AMINO ACIDS~INJECTABLE;INJECTION~FREAMINE 8.5%~B BRAUN~8.5% (8.5GM/100ML)~N~0168
22~001~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
AMINO ACIDS~INJECTABLE;INJECTION~FREAMINE HBC 6.9%~B BRAUN~6.9% (6.9GM/100ML)~N~
016822~006~~May 17, 1983~No~RX~B BRAUN MEDICAL INC
AMINO ACIDS~INJECTABLE;INJECTION~FREAMINE II 8.5%~B BRAUN~8.5% (8.5GM/100ML)~N~0
16822~002~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
AMINO ACIDS~INJECTABLE;INJECTION~FREAMINE III 10%~B BRAUN~10% (10GM/100ML)~N~016
822~005~~Approved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACET
ATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~FREAMINE III 3% W/ ELECTROLYTES~B BRAU
N~3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML~N~016822~003~~App
roved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
AMINO ACIDS~INJECTABLE;INJECTION~FREAMINE III 8.5%~B BRAUN~8.5% (8.5GM/100ML)~N~
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CH
LORIDE; SODIUM ACETATE~INJECTABLE;INJECTION~FREAMINE III 8.5% W/ ELECTROLYTES~B
BRAUN~8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML~N~016822~0
07~~Jul 1, 1988~No~RX~B BRAUN MEDICAL INC
FLOXURIDINE~INJECTABLE;INJECTION~FUDR~HOSPIRA~500MG/VIAL **Federal Register dete
reasons**~N~016929~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
FLUORESCEIN SODIUM~INJECTABLE;INJECTION~FUNDUSCEIN-25~NOVARTIS~25%~N~017869~001~
~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
AMPHOTERICIN B~INJECTABLE;INJECTION~FUNGIZONE~APOTHECON~50MG/VIAL~A~060517~001~~
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~ABRAXIS PHARM~10MG/ML~N~018507~001~~J
ul 30, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~ABRAXIS PHARM~10MG/ML~N~019036~001~~A
ug 13, 1984~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~ASTRAZENECA~10MG/ML~A~070014~001~~Sep
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~CLARIS LIFESCIENCES~10MG/ML~A~202747~
001~AP~Jan 27, 2014~No~RX~CLARIS LIFESCIENCES LTD
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~EMCURE PHARMS LTD~10MG/ML~A~203428~00

1~AP~Aug 26, 2014~No~RX~EMCURE PHARMACEUTICALS LTD
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~FRESENIUS KABI USA~10MG/ML~N~018902~0
01~AP~May 22, 1984~No~RX~FRESENIUS KABI USA LLC
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~HIKMA MAPLE ~10MG/ML~A~071439~001~~Se
p 14, 1990~No~DISCN~HIKMA MAPLE LTD
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~HIKMA MAPLE ~10MG/ML~N~018267~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~HOSPIRA~10MG/ML~A~070578~001~~Jul 8,
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~HOSPIRA~10MG/ML~A~072080~001~~Aug 13,
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~HOSPIRA~10MG/ML~A~074337~001~~Oct 31,
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~HOSPIRA~10MG/ML~A~075241~001~AP~May 2
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~HOSPIRA~10MG/ML~N~018667~001~AP~May 2
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~INTL MEDICATION~10MG/ML~N~018025~001~
~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL MEDICATION SYSTEM
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~LUITPOLD~10MG/ML~N~018579~001~AP~Nov
30, 1983~Yes~RX~LUITPOLD PHARMACEUTICALS INC
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~MARSAM PHARMS LLC~10MG/ML~A~074017~00
1~~Jun 30, 1994~No~DISCN~MARSAM PHARMACEUTICALS LLC
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~ORGANON USA INC~10MG/ML~A~070017~001~
~Dec 15, 1986~No~DISCN~ORGANON USA INC
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~SMITH AND NEPHEW~10MG/ML~A~070023~001
~~Feb 5, 1986~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~SMITH AND NEPHEW~10MG/ML~A~070078~001
~~Feb 5, 1986~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~WARNER CHILCOTT~10MG/ML~N~018420~001~
~Feb 26, 1982~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~WATSON LABS~10MG/ML~A~070019~001~~Sep
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~WATSON LABS~10MG/ML~A~070604~001~~Jan
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~WOCKHARDT~10MG/ML~A~077941~001~AP~Mar
22, 2007~No~RX~WOCKHARDT LTD
FUROSEMIDE~INJECTABLE;INJECTION~FUROSEMIDE~WYETH AYERST~10MG/ML~N~018670~001~~Ju
l 20, 1982~No~DISCN~WYETH AYERST LABORATORIES
GALLIUM CITRATE GA-67~INJECTABLE;INJECTION~GALLIUM CITRATE GA 67~GE HEALTHCARE~1
mCi/ML~N~017700~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
GALLIUM CITRATE GA-67~INJECTABLE;INJECTION~GALLIUM CITRATE GA 67~LANTHEUS MEDCL~
2mCi/ML~N~017478~001~BS~Approved Prior to Jan 1, 1982~No~RX~LANTHEUS MEDICAL IMA
GING INC
GALLIUM CITRATE GA-67~INJECTABLE;INJECTION~GALLIUM CITRATE GA 67~MALLINCKRODT~2m
Ci/ML~N~018058~001~BS~Approved Prior to Jan 1, 1982~No~RX~MALLINCKRODT MEDICAL I
NC
GANCICLOVIR SODIUM~INJECTABLE;INJECTION~GANCICLOVIR~FRESENIUS KABI USA~EQ 500MG
BASE/VIAL~A~090658~001~AP~Jun 21, 2010~No~RX~FRESENIUS KABI USA LLC
GANCICLOVIR SODIUM~INJECTABLE;INJECTION~GANCICLOVIR~LUITPOLD~EQ 500MG BASE/VIAL~
A~202624~001~AP~Sep 18, 2013~No~RX~LUITPOLD PHARMACEUTICALS INC
GANCICLOVIR SODIUM~INJECTABLE;INJECTION~GANCICLOVIR SODIUM~EUROHLTH INTL SARL~EQ
500MG BASE/VIAL~A~076222~001~~Jul 16, 2003~No~DISCN~EUROHEALTH INTERNATIONAL SA
RL
GANIRELIX ACETATE~INJECTABLE;INJECTION~GANIRELIX ACETATE~ORGANON USA INC~EQ 250M
CG BASE/0.5ML~N~021057~001~~Jul 29, 1999~Yes~RX~ORGANON USA INC
GALLIUM NITRATE~INJECTABLE;INJECTION~GANITE~CHAPTER 7 TRUSTEE~25MG/ML~N~019961~0
02~~Jan 17, 1991~No~DISCN~CHAPTER 7 TRUSTEE OF GENTA INC
SULFISOXAZOLE DIOLAMINE~INJECTABLE;INJECTION~GANTRISIN~ROCHE~EQ 400MG BASE/ML~N~
006917~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC

GENTAMICIN SULFATE~INJECTABLE;INJECTION~GARAMYCIN~SCHERING~EQ 1MG BASE/ML~A~0617
CORP
739~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUG
H CORP
H CORP
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~ACCORD
HLTHCARE~EQ 1GM BASE/VIAL~A~091594~002~AP~Jul 25, 2011~No~RX~ACCORD HEALTHCARE I
NC
HLTHCARE~EQ 2GM BASE/VIAL~A~091594~003~AP~Jul 25, 2011~No~RX~ACCORD HEALTHCARE I
NC
HLTHCARE~EQ 200MG BASE/VIAL~A~091594~001~AP~Jul 25, 2011~No~RX~ACCORD HEALTHCARE
INC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~ACTAVIS
TOTOWA~EQ 1GM BASE/VIAL~A~079160~002~AP~Jul 25, 2011~No~RX~ACTAVIS TOTOWA LLC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~ACTAVIS
TOTOWA~EQ 200MG BASE/VIAL~A~079160~001~AP~Jul 25, 2011~No~RX~ACTAVIS TOTOWA LLC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~CIPLA L
TD~EQ 1GM BASE/VIAL~A~078759~002~AP~Jul 25, 2011~No~RX~CIPLA LTD
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~CIPLA L
TD~EQ 200MG BASE/VIAL~A~078759~001~AP~Jul 25, 2011~No~RX~CIPLA LTD
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~DR REDD
YS LABS LTD~EQ 1GM BASE/VIAL~A~091365~002~AP~Jul 25, 2011~No~RX~DR REDDYS LABORA
TORIES LTD
YS LABS LTD~EQ 2GM BASE/VIAL~A~202997~001~AP~May 7, 2013~No~RX~DR REDDYS LABORAT
ORIES LTD
YS LABS LTD~EQ 200MG BASE/VIAL~A~091365~001~AP~Jul 25, 2011~No~RX~DR REDDYS LABO
RATORIES LTD
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~EMCURE
PHARMS LTD~EQ 1GM BASE/VIAL~A~202063~002~AP~Sep 11, 2012~No~RX~EMCURE PHARMACEUT
ICALS LTD
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~EMCURE
PHARMS LTD~EQ 200MG BASE/VIAL~A~202063~001~AP~Sep 11, 2012~No~RX~EMCURE PHARMACE
UTICALS LTD
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~FRESENI
US KABI ONCOL~EQ 1GM BASE/VIAL~A~090799~002~AP~Jul 25, 2011~No~RX~FRESENIUS KABI
ONCOLOGY PLC
US KABI ONCOL~EQ 2GM BASE/VIAL~A~090799~003~AP~May 16, 2011~No~RX~FRESENIUS KABI
ONCOLOGY PLC
US KABI ONCOL~EQ 200MG BASE/VIAL~A~090799~001~AP~Jul 25, 2011~No~RX~FRESENIUS KA
BI ONCOLOGY PLC
US KABI USA~EQ 2GM BASE/VIAL~A~090242~003~AP~May 16, 2011~No~RX~FRESENIUS KABI U
SA LLC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~HAMELN
RDS GMBH~EQ 1GM BASE/VIAL~A~090663~002~AP~Sep 10, 2012~No~RX~HAMELN RDS GMBH
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~HAMELN
RDS GMBH~EQ 200MG BASE/VIAL~A~090663~001~AP~Sep 10, 2012~No~RX~HAMELN RDS GMBH
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~HOSPIRA
~EQ 1GM BASE/VIAL~A~078339~002~AP~Jul 25, 2011~No~RX~HOSPIRA WORLDWIDE, INC

~EQ 200MG BASE/VIAL~A~078339~001~AP~Jul 25, 2011~No~RX~HOSPIRA WORLDWIDE, INC
INC~1GM/26.3ML (38MG/ML)~N~200795~002~~Aug 4, 2011~Yes~RX~HOSPIRA INC
INC~EQ 2GM BASE/VIAL~A~079183~001~AP~Nov 15, 2010~Yes~RX~HOSPIRA INC
INC~2GM/52.6ML (38MG/ML)~N~200795~003~~Aug 4, 2011~Yes~RX~HOSPIRA INC
INC~200MG/5.26ML (38MG/ML)~N~200795~001~~Aug 4, 2011~Yes~RX~HOSPIRA INC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~JIANGSU
HANSOH PHARM~EQ 1GM BASE/VIAL~A~202485~002~AP~May 7, 2013~No~RX~JIANGSU HANSOH
PHARMACEUTICAL CO LTD
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~JIANGSU
HANSOH PHARM~EQ 200MG BASE/VIAL~A~202485~001~AP~May 7, 2013~No~RX~JIANGSU HANSO
H PHARMACEUTICAL CO LTD
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~LUITPOL
D~EQ 1GM BASE/VIAL~A~202031~002~AP~May 7, 2013~No~RX~LUITPOLD PHARMACEUTICALS IN
C
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~LUITPOL
D~EQ 200MG BASE/VIAL~A~202031~001~AP~May 7, 2013~No~RX~LUITPOLD PHARMACEUTICALS
INC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~ONCO TH
ERAPIES LTD~EQ 1GM BASE/VIAL~A~200145~002~AP~Jul 25, 2011~No~RX~ONCO THERAPIES L
TD
ERAPIES LTD~EQ 2GM BASE/VIAL~A~200145~003~AP~Jul 25, 2011~No~RX~ONCO THERAPIES L
TD
ERAPIES LTD~EQ 200MG BASE/VIAL~A~200145~001~AP~Jul 25, 2011~No~RX~ONCO THERAPIES
LTD
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~SAGENT
PHARMS~EQ 1GM BASE/VIAL~A~091597~002~AP~May 7, 2013~No~RX~SAGENT PHARMACEUTICALS
INC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~SAGENT
PHARMS~EQ 200MG BASE/VIAL~A~091597~001~AP~May 7, 2013~No~RX~SAGENT PHARMACEUTICA
LS INC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~SUN PHA
RMA GLOBAL~EQ 1GM BASE/VIAL~A~078433~002~AP~Jul 25, 2011~No~RX~SUN PHARMA GLOBAL
INC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~SUN PHA
RMA GLOBAL~EQ 200MG BASE/VIAL~A~078433~001~AP~Jul 25, 2011~No~RX~SUN PHARMA GLOB
AL INC
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~TEVA PH
ARMS~EQ 1GM BASE/VIAL~A~077983~001~AP~Jan 25, 2011~No~RX~TEVA PHARMACEUTICALS US
A
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMCITABINE HYDROCHLORIDE~TEVA PH
ARMS~EQ 200MG BASE/VIAL~A~077983~002~AP~Jan 25, 2011~No~RX~TEVA PHARMACEUTICALS
USA
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMZAR~LILLY~EQ 1GM BASE/VIAL~N~0
20509~002~AP~May 15, 1996~Yes~RX~ELI LILLY AND CO
GEMCITABINE HYDROCHLORIDE~INJECTABLE;INJECTION~GEMZAR~LILLY~EQ 200MG BASE/VIAL~N
~020509~001~AP~May 15, 1996~Yes~RX~ELI LILLY AND CO
ARBUTAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~GENESA~GENSIA AUTOMEDICS~0.05MG/ML
~N~020420~001~~Sep 12, 1997~No~DISCN~GENSIA AUTOMEDICS INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~GENOTROPIN~PHARMACIA AND UPJOHN~5.8M
G/VIAL~N~020280~006~BX~Aug 24, 1995~Yes~RX~PHARMACIA AND UPJOHN CO
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~GENOTROPIN~PHARMACIA AND UPJOHN~13.8
MG/VIAL~N~020280~007~~Oct 23, 1996~Yes~RX~PHARMACIA AND UPJOHN CO
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~GENOTROPIN PRESERVATIVE FREE~PHARMAC
IA AND UPJOHN~0.2MG/VIAL~N~020280~001~~Jan 27, 1998~No~RX~PHARMACIA AND UPJOHN C

O
O
O
O
IA AND UPJOHN~1MG/VIAL~N~020280~008~~Jan 27, 1998~No~RX~PHARMACIA AND UPJOHN CO
O
O
IA AND UPJOHN~1.5MG/VIAL~N~020280~004~BX~Aug 24, 1995~No~RX~PHARMACIA AND UPJOHN
CO
O
O
IA AND UPJOHN~2MG/VIAL~N~020280~013~~Jan 27, 1998~Yes~RX~PHARMACIA AND UPJOHN CO
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAFAIR~PHARMAFAIR~EQ 40MG BASE/ML~A~0
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN~INTL MEDICATION~EQ 1MG BASE/M
L~A~062325~003~~Jun 23, 1982~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN~INTL MEDICATION~EQ 40MG BASE/
ML~A~062325~001~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL MEDICATION
SYSTEMS LTD
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN~INTL MEDICATION~EQ 100MG BASE
/100ML~A~062325~004~~Jun 23, 1982~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~ABBOTT~EQ 1.2MG BASE/
ML~A~062413~001~~Aug 11, 1983~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUC
TS DIV
TS DIV
TS DIV
TS DIV
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~ABBOTT~EQ 2MG BASE/ML
~A~062413~005~~Aug 11, 1983~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS
DIV
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~ABBOTT~EQ 60MG BASE/1
00ML~A~062413~006~~Aug 11, 1983~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PROD
UCTS DIV
UCTS DIV

UCTS DIV
UCTS DIV
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~ABBOTT~EQ 100MG BASE/
100ML~A~062413~010~~Aug 11, 1983~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRO
DUCTS DIV
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~FRESENIUS KABI USA~EQ
10MG BASE/ML~A~062356~001~~Mar 4, 1982~No~DISCN~FRESENIUS KABI USA LLC
10MG BASE/ML~A~062366~002~AP~Feb 6, 1986~No~RX~FRESENIUS KABI USA LLC
40MG BASE/ML~A~062356~002~~Mar 4, 1982~No~DISCN~FRESENIUS KABI USA LLC
40MG BASE/ML~A~062366~001~AP~Aug 4, 1983~Yes~RX~FRESENIUS KABI USA LLC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~HIKMA MAPLE ~EQ 10MG
BASE/ML~A~062251~002~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~HIKMA MAPLE ~EQ 40MG
BASE/ML~A~062251~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~HOSPIRA~EQ 10MG BASE/
ML~A~062420~001~AP~Aug 15, 1983~No~RX~HOSPIRA INC
ML~A~062612~004~AP~Feb 20, 1986~No~RX~HOSPIRA INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~KALAPHARM~EQ 40MG BAS
E/ML~A~062354~001~~Apr 5, 1982~No~DISCN~KALAPHARM INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~PHARM SPEC~EQ 40MG BA
SE/ML~A~062340~001~~Mar 28, 1983~No~DISCN~PHARMACEUTICAL SPECIALIST ASSOC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~SOLOPAK~EQ 10MG BASE/
ML~A~062507~001~~Jun 6, 1985~No~DISCN~SOLOPAK LABORATORIES INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~SOLOPAK~EQ 40MG BASE/
ML~A~062507~002~~Jun 6, 1985~No~DISCN~SOLOPAK LABORATORIES INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~TEVA PARENTERAL~EQ 10
MG BASE/ML~A~063149~001~~Nov 21, 1991~No~DISCN~TEVA PARENTERAL MEDICINES INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~TEVA PARENTERAL~EQ 40
MG BASE/ML~A~063106~002~~Nov 21, 1991~No~DISCN~TEVA PARENTERAL MEDICINES INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~WATSON LABS~EQ 10MG B
ASE/ML~A~062318~002~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES
INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~WATSON LABS~EQ 40MG B
ASE/ML~A~062318~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES
INC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~WYETH AYERST~EQ 10MG
BASE/ML~A~062264~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORA
TORIES
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE~WYETH AYERST~EQ 40MG
BASE/ML~A~062264~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORA
TORIES
GENTAMICIN SULFATE~INJECTABLE;INJECTION~GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.
9% IN PLASTIC CONTAINER~B BRAUN~EQ 0.8MG BASE/ML~A~062814~001~AP~Aug 28, 1987~Ye
s~RX~B BRAUN MEDICAL INC

9% IN PLASTIC CONTAINER~B BRAUN~EQ 2MG BASE/ML~A~062814~006~AP~Aug 28, 1987~Yes~
RX~B BRAUN MEDICAL INC
9% IN PLASTIC CONTAINER~B BRAUN~EQ 40MG BASE/100ML~A~062814~008~AP~Aug 28, 1987~
Yes~RX~B BRAUN MEDICAL INC
9% IN PLASTIC CONTAINER~B BRAUN~EQ 100MG BASE/100ML~A~062814~013~AP~Aug 28, 1987
~Yes~RX~B BRAUN MEDICAL INC
9% IN PLASTIC CONTAINER~B BRAUN~EQ 120MG BASE/100ML~A~062814~014~AP~Aug 28, 1987
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 1.2MG BASE/ML~A~062414~001~AP~Aug 15, 1983~No
~RX~HOSPIRA INC
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 1.2MG BASE/ML~A~062588~001~~Jan 6, 1986~No~DI
SCN~HOSPIRA INC
~RX~HOSPIRA INC
SCN~HOSPIRA INC
~RX~HOSPIRA INC
SCN~HOSPIRA INC
~RX~HOSPIRA INC
SCN~HOSPIRA INC
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 2MG BASE/ML~A~062414~005~AP~Aug 15, 1983~No~R
X~HOSPIRA INC

9% IN PLASTIC CONTAINER~HOSPIRA~EQ 2MG BASE/ML~A~062588~005~~Jan 6, 1986~No~DISC
N~HOSPIRA INC
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 60MG BASE/100ML~A~062414~006~AP~Aug 15, 1983~
No~RX~HOSPIRA INC
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 60MG BASE/100ML~A~062588~006~~Jan 6, 1986~No~
DISCN~HOSPIRA INC
No~RX~HOSPIRA INC
DISCN~HOSPIRA INC
No~RX~HOSPIRA INC
DISCN~HOSPIRA INC
No~RX~HOSPIRA INC
DISCN~HOSPIRA INC
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 100MG BASE/100ML~A~062414~010~AP~Aug 15, 1983
~No~RX~HOSPIRA INC
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 100MG BASE/100ML~A~062588~010~~Jan 6, 1986~No
~DISCN~HOSPIRA INC
CARBENICILLIN DISODIUM~INJECTABLE;INJECTION~GEOPEN~ROERIG~EQ 1GM BASE/VIAL~N~050
306~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROERIG DIV PFIZER INC
SERMORELIN ACETATE~INJECTABLE;INJECTION~GEREF~EMD SERONO~EQ 0.05MG BASE/AMP **Fe
safety or efficacy reasons**~N~019863~001~~Dec 28, 1990~No~DISCN~EMD SERONO INC
SERMORELIN ACETATE~INJECTABLE;INJECTION~GEREF~EMD SERONO INC~EQ 0.5MG BASE/VIAL
for safety or efficacy reasons**~N~020443~001~~Sep 26, 1997~No~DISCN~EMD SERONO
INC
SERMORELIN ACETATE~INJECTABLE;INJECTION~GEREF~EMD SERONO INC~EQ 1MG BASE/VIAL **
Federal Register determination that product was not discontinued or withdrawn fo
r safety or efficacy reasons**~N~020443~002~~Sep 26, 1997~No~DISCN~EMD SERONO IN
C
IOTHALAMATE SODIUM I-125~INJECTABLE;INJECTION~GLOFIL-125~ISOTEX~250-300uCi/ML~N~
017279~001~~Approved Prior to Jan 1, 1982~No~RX~ISOTEX DIAGNOSTICS
GLUCAGON HYDROCHLORIDE RECOMBINANT~INJECTABLE;INJECTION~GLUCAGEN~NOVO NORDISK~EQ
1MG BASE/VIAL~N~020918~001~~Jun 22, 1998~Yes~RX~NOVO NORDISK PHARMACEUTICALS IN
C
GLUCAGON HYDROCHLORIDE~INJECTABLE;INJECTION~GLUCAGON~LILLY~EQ 1MG BASE/VIAL~N~01

GLUCAGON RECOMBINANT~INJECTABLE;INJECTION~GLUCAGON~LILLY~1MG/VIAL~N~020928~001~~
Sep 11, 1998~Yes~RX~ELI LILLY AND CO
GLUCAGON HYDROCHLORIDE~INJECTABLE;INJECTION~GLUCAGON~LILLY~EQ 10MG BASE/VIAL~N~0
TECHNETIUM TC-99M GLUCEPTATE KIT~INJECTABLE;INJECTION~GLUCOSCAN~BRISTOL MYERS SQ
UIBB~N/A~N~017907~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUI
BB PHARMA CO
GLYCOPYRROLATE~INJECTABLE;INJECTION~GLYCOPYRROLATE~ABRAXIS PHARM~0.2MG/ML~A~0884
75~001~~Jun 12, 1984~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
GLYCOPYRROLATE~INJECTABLE;INJECTION~GLYCOPYRROLATE~HIKMA FARMACEUTICA~0.2MG/ML~A
~090963~001~AP~Sep 21, 2011~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
GLYCOPYRROLATE~INJECTABLE;INJECTION~GLYCOPYRROLATE~HOSPIRA~0.2MG/ML~A~089393~001
~~Jun 15, 1988~No~DISCN~HOSPIRA INC
GLYCOPYRROLATE~INJECTABLE;INJECTION~GLYCOPYRROLATE~LUITPOLD~0.2MG/ML~A~089335~00
1~AP~Jul 23, 1986~No~RX~LUITPOLD PHARMACEUTICALS INC
GLYCOPYRROLATE~INJECTABLE;INJECTION~GLYCOPYRROLATE~TEVA PARENTERAL~0.2MG/ML~A~08
1169~001~~Sep 10, 1991~No~DISCN~TEVA PARENTERAL MEDICINES INC
GLYCOPYRROLATE~INJECTABLE;INJECTION~GLYCOPYRROLATE~WATSON LABS~0.2MG/ML~A~086947
~001~~Jun 24, 1983~No~DISCN~WATSON LABORATORIES INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~AKORN I
NC~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~079119~001~AP~Sep 10, 2009~No~RX~AKORN
INC
NC~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~079078~001~AP~Sep 14, 2009~No~RX~AKORN INC
NC~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~079078~002~AP~Sep 14, 2009~No~RX~AKORN INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~APOTEX
INC~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~078197~001~~Dec 31, 2007~No~DISCN~APOT
EX INC
INC~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~078198~001~~Jun 30, 2008~No~DISCN~APOTEX I
NC
INC~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~078198~002~~Jun 30, 2008~No~DISCN~APOTEX
INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~BANNER
LIFE SCIENCES~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~078863~001~AP~Jun 30, 2008~N
o~RX~BANNER LIFE SCIENCES LLC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~BANNER
LIFE SCIENCES~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~078880~001~AP~Jun 30, 2008~No~R
X~BANNER LIFE SCIENCES LLC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~BEDFORD
LABS~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~077913~001~AP~Jun 26, 2008~No~RX~BED
FORD LABORATORIES
LABS~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~077186~001~AP~Jun 30, 2008~No~RX~BEDFOR
D LABORATORIES
LABS~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~077187~001~AP~Jun 30, 2008~No~RX~BEDFORD
LABORATORIES
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~CIPLA L
TD~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~078262~001~AP~Dec 31, 2007~No~RX~CIPLA
LTD
TD~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~078258~001~AP~Jun 30, 2008~No~RX~CIPLA LTD
TD~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~078258~002~AP~Jun 30, 2008~No~RX~CIPLA LTD
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~FRESENI
US KABI USA~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~078522~001~AP~Dec 31, 2007~No~
RX~FRESENIUS KABI USA LLC

GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~FRESENI
US KABI USA~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~078090~001~AP~Jun 30, 2008~No~RX~
FRESENIUS KABI USA LLC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~HIKMA M
APLE ~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~077177~001~AP~Dec 31, 2007~No~RX~HIKMA
MAPLE LTD
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~LUITPOL
D~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~091274~001~AP~Sep 22, 2010~No~RX~LUITPOLD PH
ARMACEUTICALS INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~SAGENT
AGILA~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~091137~002~AP~Apr 9, 2010~No~RX~SAGENT
AGILA LLC
STRIDES~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~091136~001~AP~Apr 9, 2010~No~RX~SA
GENT STRIDES LLC
STRIDES~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~091136~002~AP~Apr 9, 2010~No~RX~SAGENT
STRIDES LLC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~SANDOZ~
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~078534~001~AP~Apr 30, 2009~No~RX~SANDOZ CA
NADA INC
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~078808~001~~Apr 29, 2008~No~DISCN~SANDOZ I
NC
EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~078531~001~AP~Apr 30, 2009~No~RX~SANDOZ CANADA
INC
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~078531~002~AP~Apr 30, 2009~No~RX~SANDOZ CANAD
A INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~SANDOZ
INC~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~078835~001~AP~Jun 30, 2008~No~RX~SANDOZ IN
C
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~SANDOZ
INC~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~078835~002~AP~Jun 30, 2008~No~RX~SANDOZ I
NC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~TEVA PH
ARMS USA~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~078392~001~AP~Dec 31, 2007~Yes~RX
ARMS USA~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~077963~001~AP~Jan 3, 2008~Yes~RX~TEVA
PHARMACEUTICALS USA
ARMS USA~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~077297~001~AP~Jun 30, 2008~Yes~RX~TE
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE~WOCKHAR
DT USA~EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)~A~078566~001~AP~Feb 29, 2008~No~RX~WO
CKHARDT USA INC
DT USA~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~078564~001~AP~Jun 30, 2008~No~RX~WOCKHA
RDT USA INC
DT USA~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~078565~001~AP~Jun 30, 2008~No~RX~WOCKH
ARDT USA INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISETRON HYDROCHLORIDE PRESERV
ATIVE FREE~BANNER LIFE SCIENCES~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~078863~002~AP~
Jun 30, 2008~No~RX~BANNER LIFE SCIENCES LLC
ATIVE FREE~FRESENIUS KABI USA~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~078096~001~AP~Ju
n 30, 2008~Yes~RX~FRESENIUS KABI USA LLC

ATIVE FREE~TEVA PHARMS USA~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~077165~001~~Dec 31,
2007~No~DISCN~TEVA PHARMACEUTICALS USA
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISTERON HYDROCHLORIDE~HIKMA F
ARMACEUTICA~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~A~078629~001~AP~Dec 23, 2009~No~RX~H
IKMA FARMACEUTICA (PORTUGAL) SA
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~GRANISTERON HYDROCHLORIDE~HIKMA F
ARMACEUTICA~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~A~078629~002~AP~Dec 23, 2009~No~RX~
HIKMA FARMACEUTICA (PORTUGAL) SA
CORTICOTROPIN~INJECTABLE;INJECTION~H.P. ACTHAR GEL~QUESTCOR PHARMS~40 UNITS/ML~N
~008372~006~~Approved Prior to Jan 1, 1982~No~DISCN~QUESTCOR PHARMACEUTICALS INC
CORTICOTROPIN~INJECTABLE;INJECTION~H.P. ACTHAR GEL~QUESTCOR PHARMS~80 UNITS/ML~N
~008372~008~~Approved Prior to Jan 1, 1982~Yes~RX~QUESTCOR PHARMACEUTICALS INC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALDOL~JANSSEN PHARMS~EQ 5MG BASE/ML~N~
015923~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~JANSSEN PHARMACEUTICALS INC
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALDOL~JANSSEN PHARMS~EQ 50MG BASE/ML
~N~018701~001~AO~Jan 14, 1986~Yes~RX~JANSSEN PHARMACEUTICALS INC
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALDOL~JANSSEN PHARMS~EQ 100MG BASE/M
L~N~018701~002~AO~Jan 31, 1997~Yes~RX~JANSSEN PHARMACEUTICALS INC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~ABRAXIS PHARM~EQ 5MG BASE/M
L~A~071187~001~~Jan 20, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~AGILA SPECLTS~EQ 5MG BASE/M
L~A~078347~001~AP~Sep 14, 2009~No~RX~AGILA SPECIALTIES PRIVATE LTD
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~APOTEX INC~EQ 5MG BASE/ML~A
~076791~001~~Aug 25, 2004~No~DISCN~APOTEX INC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~APOTEX INC~EQ 5MG BASE/ML~A
~076828~001~~Aug 25, 2004~No~DISCN~APOTEX INC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~EUROHLTH INTL SARL~EQ 5MG B
ASE/ML~A~075858~001~AP~Jun 18, 2001~No~RX~EUROHEALTH INTERNATIONAL SARL
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~FRESENIUS KABI USA~EQ 5MG B
ASE/ML~A~075689~001~AP~Mar 9, 2001~No~RX~FRESENIUS KABI USA LLC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~GLAND PHARMA LTD~EQ 5MG BAS
E/ML~A~076774~001~AP~Aug 25, 2004~No~RX~GLAND PHARMA LTD
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~MARSAM PHARMS LLC~EQ 5MG BA
SE/ML~A~072516~001~~Feb 25, 1993~No~DISCN~MARSAM PHARMACEUTICALS LLC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~MARSAM PHARMS LLC~EQ 5MG BA
SE/ML~A~072517~001~~Feb 25, 1993~No~DISCN~MARSAM PHARMACEUTICALS LLC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~SAGENT PHARMS~EQ 5MG BASE/M
L~A~091637~001~AP~Sep 2, 2011~No~RX~SAGENT PHARMACEUTICALS INC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~SAGENT PHARMS~EQ 5MG BASE/M
L~A~200742~001~AP~Sep 2, 2011~No~RX~SAGENT PHARMACEUTICALS INC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~SANDOZ~EQ 5MG BASE/ML~A~076
464~001~~Sep 29, 2004~No~DISCN~SANDOZ CANADA INC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~SMITH AND NEPHEW~EQ 5MG BAS
E/ML~A~070802~001~~Dec 14, 1987~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND
NEPHEW
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~SOLOPAK~EQ 5MG BASE/ML~A~07
0800~001~~Dec 14, 1987~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
0801~001~~Dec 14, 1987~No~DISCN~SOLOPAK LABORATORIES INC
0864~001~~Dec 14, 1987~No~DISCN~SOLOPAK LABORATORIES INC
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~TEVA PHARMS USA~EQ 5MG BASE
/ML~A~076035~001~AP~Aug 29, 2001~No~RX~TEVA PHARMACEUTICALS USA
HALOPERIDOL LACTATE~INJECTABLE;INJECTION~HALOPERIDOL~WATSON LABS~EQ 5MG BASE/ML~
A~070713~001~~May 17, 1988~No~DISCN~WATSON LABORATORIES INC

HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~AGILA SPECLTS~E
Q 50MG BASE/ML~A~075440~001~AO~Feb 28, 2000~No~RX~AGILA SPECIALTIES PRIVATE LTD
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~AGILA SPECLTS~E
Q 100MG BASE/ML~A~075440~002~AO~Feb 28, 2000~No~RX~AGILA SPECIALTIES PRIVATE LTD
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~EUROHLTH INTL S
ARL~EQ 50MG BASE/ML~A~074811~001~AO~Jan 30, 1998~No~RX~EUROHEALTH INTERNATIONAL
SARL
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~EUROHLTH INTL S
ARL~EQ 100MG BASE/ML~A~075305~001~AO~Sep 28, 1998~No~RX~EUROHEALTH INTERNATIONAL
SARL
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~FRESENIUS KABI
USA~EQ 50MG BASE/ML~A~074893~001~AO~Dec 19, 1997~No~RX~FRESENIUS KABI USA LLC
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~FRESENIUS KABI
USA~EQ 100MG BASE/ML~A~074893~002~AO~Dec 19, 1997~No~RX~FRESENIUS KABI USA LLC
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~HOSPIRA~EQ 50MG
BASE/ML~A~075176~001~~Feb 9, 2000~No~DISCN~HOSPIRA INC
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~HOSPIRA~EQ 100M
G BASE/ML~A~075176~002~~Feb 9, 2000~No~DISCN~HOSPIRA INC
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~SANDOZ~EQ 50MG
BASE/ML~A~076463~001~~Jun 24, 2005~No~DISCN~SANDOZ CANADA INC
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~SANDOZ~EQ 100MG
BASE/ML~A~076463~002~~Jun 24, 2005~No~DISCN~SANDOZ CANADA INC
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~TEVA PHARMS USA
~EQ 50MG BASE/ML~A~075393~001~AO~May 11, 1999~No~RX~TEVA PHARMACEUTICALS USA
HALOPERIDOL DECANOATE~INJECTABLE;INJECTION~HALOPERIDOL DECANOATE~TEVA PHARMS USA
~EQ 100MG BASE/ML~A~075393~002~AO~May 11, 1999~No~RX~TEVA PHARMACEUTICALS USA
DIBUCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~HEAVY SOLUTION NUPERCAINE~NOVARTIS~
2.5MG/ML~N~006203~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEU
TICALS CORP
DOXERCALCIFEROL~INJECTABLE;INJECTION~HECTOROL~GENZYME CORP~2MCG/ML (2MCG/ML)~N~0
21027~002~~Apr 6, 2000~No~RX~GENZYME CORP
DOXERCALCIFEROL~INJECTABLE;INJECTION~HECTOROL~GENZYME CORP~4MCG/2ML (2MCG/ML)~N~
021027~001~AP~Apr 6, 2000~Yes~RX~GENZYME CORP
CARBOPROST TROMETHAMINE~INJECTABLE;INJECTION~HEMABATE~PHARMACIA AND UPJOHN~EQ 0.
25MG BASE/ML~N~017989~001~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UP
JOHN CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~HOSPIRA~100 UNITS/ML~N~00
5264~010~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~INTL MEDICATION~10 UNITS/
SYSTEMS LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~INTL MEDICATION~500 UNITS
/ML~A~086357~002~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL MEDICATIO
N SYSTEMS LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~LUITPOLD~10 UNITS/ML~A~08
9063~001~~Oct 9, 1985~No~DISCN~LUITPOLD PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~LUITPOLD~100 UNITS/ML~A~0
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~PARKE DAVIS~10 UNITS/ML~N
RT CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~SMITH AND NEPHEW~10 UNITS
/ML~A~087904~001~~Apr 20, 1983~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND N
EPHEW
/ML~A~087958~001~~Apr 20, 1983~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND N
EPHEW
/ML~A~088458~001~~Jul 26, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND N
EPHEW
/ML~A~088580~001~~Oct 25, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND N
EPHEW
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~SMITH AND NEPHEW~100 UNIT
S/ML~A~087906~001~~Apr 20, 1983~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND
NEPHEW
S/ML~A~087959~001~~Apr 20, 1983~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND
NEPHEW
S/ML~A~088460~001~~Jul 26, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND
NEPHEW
S/ML~A~088581~001~~Oct 25, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND
NEPHEW
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN LOCK FLUSH~SOLOPAK~10 UNITS/ML~A~087
903~001~~Apr 20, 1983~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
457~001~~Oct 25, 1984~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
7905~001~~Apr 20, 1983~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
8459~001~~Jul 26, 1984~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~ABRAXIS PHARM~1,000 UNITS/ML~
N~017033~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PROD
UCTS
UCTS
UCTS
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~ABRAXIS PHARM~10,000 UNITS/ML
~N~017979~002~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRO
DUCTS
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~AKORN~1,000 UNITS/ML~N~017486
~001~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
~002~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
6~003~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~BAXTER HLTHCARE CORP~1,000 UN
ITS/ML~N~017007~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CO
RP ANESTHESIA CRITICAL CARE
ITS/0.5ML~N~017007~010~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE
CORP ANESTHESIA CRITICAL CARE

HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~BAXTER HLTHCARE CORP~10,000 U
NITS/ML~N~017007~004~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE C
ORP ANESTHESIA CRITICAL CARE
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~CHAMBERLIN PARENTERL~1,000 UN
ITS/ML~N~017130~001~~Approved Prior to Jan 1, 1982~No~DISCN~CHAMBERLIN PARENTERA
L CORP
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~CHAMBERLIN PARENTERL~5,000 UN
ITS/ML~N~017130~002~~Approved Prior to Jan 1, 1982~No~DISCN~CHAMBERLIN PARENTERA
L CORP
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~CHAMBERLIN PARENTERL~10,000 U
NITS/ML~N~017130~003~~Approved Prior to Jan 1, 1982~No~DISCN~CHAMBERLIN PARENTER
AL CORP
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~CHAMBERLIN PARENTERL~20,000 U
NITS/ML~N~017130~004~~Approved Prior to Jan 1, 1982~No~DISCN~CHAMBERLIN PARENTER
AL CORP
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~DELL LABS~1,000 UNITS/ML~N~01
7540~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~FRESENIUS KABI USA~1,000 UNIT
S/ML~N~017029~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
S/ML~N~017651~005~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS KABI USA LLC
S/ML~N~017029~002~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS KABI USA LLC
S/ML~N~017651~006~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~FRESENIUS KABI USA~10,000 UNI
TS/ML~N~017029~003~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LL
C
TS/ML~N~017029~020~~Mar 31, 2011~Yes~RX~FRESENIUS KABI USA LLC
TS/ML~N~017651~003~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS KABI USA LL
C
TS/ML~N~017029~004~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LL
C
TS/ML~N~017651~008~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS KABI USA LL
C
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~HIKMA MAPLE ~1,000 UNITS/ML~N
~017037~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~HIKMA MAPLE ~5,000 UNITS/ML~N
~017037~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~HIKMA MAPLE ~5,000 UNITS/0.5M
L~N~017037~013~~Apr 7, 1986~No~DISCN~HIKMA MAPLE LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~HIKMA MAPLE ~10,000 UNITS/ML~

N~017037~003~AP~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~HOSPIRA~2,500 UNITS/ML~A~0880
00~001~~Apr 28, 1983~Yes~RX~HOSPIRA INC
095~001~~Jul 26, 1996~No~DISCN~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~HOSPIRA INC~1,000 UNITS/ML~A~
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~HOSPIRA INC~5,000 UNITS/ML~A~
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~HOSPIRA INC~10,000 UNITS/ML~A
~090571~003~AP~Aug 31, 2009~No~RX~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~LILLY~1,000 UNITS/ML~N~005521
~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~LUITPOLD~1,000 UNITS/ML~A~087
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~ORGANON USA INC~1,000 UNITS/M
L~N~000552~008~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~ORGANON USA INC~5,000 UNITS/M
L~N~000552~009~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~ORGANON USA INC~10,000 UNITS/
ML~N~000552~010~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PARKE DAVIS~1,000 UNITS/ML~N~
017346~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBER
T CO
T CO
T CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PARKE DAVIS~10,000 UNITS/ML~N
RT CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PARKE DAVIS~20,000 UNITS/ML~N
RT CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PFIZER~1,000 UNITS/ML~N~20137
0~001~~Jul 21, 2011~Yes~RX~PFIZER INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PHARM SPEC~1,000 UNITS/ML~N~0
17780~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL SPECIALIST ASSO
C
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PHARM SPEC~5,000 UNITS/ML~N~0
17780~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL SPECIALIST ASSO
C
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PHARM SPEC~10,000 UNITS/ML~N~
017780~003~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL SPECIALIST ASS
OC
OC
OC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PHARMACIA AND UPJOHN~1,000 UN
ITS/ML~N~004570~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN
CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PHARMACIA AND UPJOHN~5,000 UN
ITS/ML~N~004570~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN
CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~PHARMACIA AND UPJOHN~10,000 U
NITS/ML~N~004570~003~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOH
N CO
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SAGENT PHARMS~1,000 UNITS/ML~
A~090808~001~AP~Jun 30, 2010~No~RX~SAGENT PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SAGENT PHARMS~5,000 UNITS/ML~
A~090808~002~AP~Jun 30, 2010~No~RX~SAGENT PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SAGENT PHARMS~10,000 UNITS/ML
~A~090808~003~AP~Jun 30, 2010~No~RX~SAGENT PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SAGENT PHARMS~20,000 UNITS/ML
~A~090809~001~AP~Jun 30, 2010~No~RX~SAGENT PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SANDOZ~1,000 UNITS/ML~A~09168
2~001~AP~Jun 8, 2011~No~RX~SANDOZ INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SHENZHEN TECHDOW~1,000 UNITS/
ML~A~202957~001~AP~Jun 12, 2014~No~RX~SHENZHEN TECHDOW PHARMACEUTICAL CO LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SHENZHEN TECHDOW~10,000 UNITS
/ML~A~203198~001~AP~Jun 12, 2014~No~RX~SHENZHEN TECHDOW PHARMACEUTICAL CO LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SHENZHEN TECHDOW~20,000 UNITS
/ML~A~203198~002~AP~Jun 12, 2014~No~RX~SHENZHEN TECHDOW PHARMACEUTICAL CO LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SMITH AND NEPHEW~1,000 UNITS/
ML~A~088239~001~~Jul 26, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NE
PHEW
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SOLOPAK~1,000 UNITS/ML~A~0870
43~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SOLOPAK~5,000 UNITS/0.5ML~A~0
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~SOLOPAK~10,000 UNITS/0.5ML~A~
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~WATSON LABS~1,000 UNITS/ML~N~

HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~WATSON LABS~10,000 UNITS/ML~N
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~WATSON LABS INC~1,000 UNITS/M
L~A~040007~001~~Jun 7, 1996~No~DISCN~WATSON LABORATORIES INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM~WATSON LABS INC~1,000 UNITS/M
L~A~040008~001~~Oct 10, 1995~No~DISCN~WATSON LABORATORIES INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORI
DE 0.9% IN PLASTIC CONTAINER~BAXTER HLTHCARE~200 UNITS/100ML~N~018609~001~AP~Apr
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN
PLASTIC CONTAINER~MCGAW~200 UNITS/100ML~N~019130~001~~Dec 31, 1984~No~DISCN~MCG
AW INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORID
E 0.9% IN PLASTIC CONTAINER~B BRAUN~200 UNITS/100ML~N~019042~001~~Mar 29, 1985~N
o~DISCN~B BRAUN MEDICAL INC
E 0.9% IN PLASTIC CONTAINER~B BRAUN~200 UNITS/100ML~N~019953~001~AP~Jul 20, 1992
E 0.9% IN PLASTIC CONTAINER~HOSPIRA~200 UNITS/100ML~N~018916~010~AP~Jun 23, 1989
~No~RX~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5%
IN PLASTIC CONTAINER~BAXTER HLTHCARE~2,000 UNITS/100ML~N~018814~002~~Jul 9, 1985
~No~DISCN~BAXTER HEALTHCARE CORP
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%~H
OSPIRA~10,000 UNITS/100ML~N~018911~006~~Jan 30, 1985~No~DISCN~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% I
N PLASTIC CONTAINER~HOSPIRA~10,000 UNITS/100ML~N~019339~003~AP~Mar 27, 1985~No~R
X~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORI
DE 0.45%~HOSPIRA~10,000 UNITS/100ML~N~018911~001~~Jan 30, 1985~No~DISCN~HOSPIRA
INC
DE 0.45%~HOSPIRA~10,000 UNITS/100ML~N~018916~005~~Jan 31, 1984~No~DISCN~HOSPIRA
INC
DE 0.9%~HOSPIRA~10,000 UNITS/100ML~N~018911~003~~Jan 30, 1985~No~DISCN~HOSPIRA I
NC
DE 0.9%~HOSPIRA~10,000 UNITS/100ML~N~018916~002~~Jan 31, 1984~No~DISCN~HOSPIRA I
NC
N PLASTIC CONTAINER~HOSPIRA~5,000 UNITS/100ML~N~019339~001~~Mar 27, 1985~No~RX~H
OSPIRA INC
DE 0.45% IN PLASTIC CONTAINER~B BRAUN~5,000 UNITS/100ML~N~019802~001~~Jul 20, 19
92~No~DISCN~B BRAUN MEDICAL INC
DE 0.45% IN PLASTIC CONTAINER~HOSPIRA~5,000 UNITS/100ML~N~018916~006~~Jan 31, 19

DE 0.9%~HOSPIRA~5,000 UNITS/100ML~N~018911~005~~Jan 30, 1985~No~DISCN~HOSPIRA IN
C
C
DE 0.9% IN PLASTIC CONTAINER~BAXTER HLTHCARE~200 UNITS/100ML~N~018609~002~AP~Apr
PLASTIC CONTAINER~MCGAW~200 UNITS/100ML~N~019130~003~~Dec 31, 1984~No~DISCN~MCG
AW INC
E 0.9% IN PLASTIC CONTAINER~B BRAUN~200 UNITS/100ML~N~019042~002~~Mar 29, 1985~N
o~DISCN~B BRAUN MEDICAL INC
E 0.9% IN PLASTIC CONTAINER~HOSPIRA~200 UNITS/100ML~N~018916~011~AP~Jun 23, 1989
~No~RX~HOSPIRA INC
IN PLASTIC CONTAINER~BAXTER HLTHCARE~4,000 UNITS/100ML~N~018814~001~~Oct 31, 198
N PLASTIC CONTAINER~B BRAUN~4,000 UNITS/100ML~N~019952~001~AP~Jul 20, 1992~Yes~R
X~B BRAUN MEDICAL INC
N PLASTIC CONTAINER~HOSPIRA~4,000 UNITS/100ML~N~019805~001~AP~Jan 25, 1989~No~RX
~HOSPIRA INC
~No~DISCN~BAXTER HEALTHCARE CORP
N PLASTIC CONTAINER~B BRAUN~5,000 UNITS/100ML~N~019134~001~~Mar 29, 1985~No~DISC
N~B BRAUN MEDICAL INC
N PLASTIC CONTAINER~B BRAUN~5,000 UNITS/100ML~N~019952~004~AP~Jul 20, 1992~Yes~R
N PLASTIC CONTAINER~B BRAUN~10,000 UNITS/100ML~N~019952~005~AP~Jul 20, 1992~Yes~
RX~B BRAUN MEDICAL INC
N PLASTIC CONTAINER~HOSPIRA~5,000 UNITS/100ML~N~019339~004~AP~Mar 27, 1985~No~RX
~HOSPIRA INC
N PLASTIC CONTAINER~HOSPIRA~5,000 UNITS/100ML~N~019805~002~AP~Jan 25, 1989~No~RX
~HOSPIRA INC
N PLASTIC CONTAINER~HOSPIRA~10,000 UNITS/100ML~N~019339~002~AP~Mar 27, 1985~No~R
X~HOSPIRA INC

C
DE 0.9% IN PLASTIC CONTAINER~B BRAUN~5,000 UNITS/100ML~N~019135~001~~Mar 29, 198
DE 0.9% IN PLASTIC CONTAINER~BAXTER HLTHCARE~500 UNITS/100ML~N~018609~003~~Apr 2
8, 1982~No~DISCN~BAXTER HEALTHCARE CORP
PLASTIC CONTAINER~MCGAW~1,000 UNITS/100ML~N~019130~002~~Dec 31, 1984~No~DISCN~M
CGAW INC
E 0.45%~HOSPIRA~100 UNITS/ML~N~018911~002~~Jan 30, 1985~No~DISCN~HOSPIRA INC
E 0.45%~HOSPIRA~100 UNITS/ML~N~018916~004~~Jan 31, 1984~No~DISCN~HOSPIRA INC
E 0.9%~HOSPIRA~1,000 UNITS/100ML~N~018916~001~~Jan 31, 1984~No~DISCN~HOSPIRA INC
E 0.9% IN PLASTIC CONTAINER~B BRAUN~1,000 UNITS/100ML~N~019042~004~~Mar 29, 1985
~No~DISCN~B BRAUN MEDICAL INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM IN PLASTIC CONTAINER~FRESENIU
S KABI USA~1,000 UNITS/ML~N~017029~013~AP~Dec 5, 1985~Yes~RX~FRESENIUS KABI USA
LLC
LLC
LLC
LLC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~FRESENIUS K
ABI USA~1,000 UNITS/ML~N~017029~010~AP~Apr 28, 1986~Yes~RX~FRESENIUS KABI USA LL
C
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~FRESENIUS K
ABI USA~10,000 UNITS/ML~N~017029~019~~Nov 22, 2010~Yes~RX~FRESENIUS KABI USA LLC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~HOSPIRA~2,0
00 UNITS/ML~N~005264~013~~Apr 7, 1986~No~DISCN~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~HOSPIRA~2,5
00 UNITS/ML~N~005264~014~~Apr 7, 1986~No~DISCN~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~HOSPIRA~10,
000 UNITS/ML~A~089522~001~~May 4, 1987~Yes~RX~HOSPIRA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~PFIZER~1,00
0 UNITS/ML~N~201370~004~~Jul 21, 2011~Yes~RX~PFIZER INC

HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~PHARMA SERV
E NY~1,000 UNITS/ML~A~086129~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMA
SERVE INC SUB TORIGIAN LABORATORIES
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~SAGENT PHAR
MS~1,000 UNITS/ML~A~090810~001~AP~Jun 30, 2010~No~RX~SAGENT PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~SHENZHEN TE
CHDOW~1,000 UNITS/ML~A~202732~001~AP~Jun 12, 2014~No~RX~SHENZHEN TECHDOW PHARMAC
EUTICAL CO LTD
HEPARIN SODIUM~INJECTABLE;INJECTION~HEPARIN SODIUM PRESERVATIVE FREE~WATSON LABS
INC~1,000 UNITS/ML~A~089464~001~~Jun 3, 1986~No~DISCN~WATSON LABORATORIES INC
AMINO ACIDS~INJECTABLE;INJECTION~HEPATAMINE 8%~B BRAUN~8% (8GM/100ML)~N~018676~0
01~~Aug 3, 1982~No~RX~B BRAUN MEDICAL INC
AMINO ACIDS~INJECTABLE;INJECTION~HEPATASOL 8%~BAXTER HLTHCARE~8% (8GM/100ML)~A~0
20360~001~~Apr 4, 1996~No~DISCN~BAXTER HEALTHCARE CORP
TECHNETIUM TC-99M DISOFENIN KIT~INJECTABLE;INJECTION~HEPATOLITE~PHARMALUCENCE~N/
A~N~018467~001~~Mar 16, 1982~No~RX~PHARMALUCENCE INC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~HEXA-BETALIN~LILLY~100MG/ML~A~0808
IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM~INJECTABLE;INJECTION~HEXABRIX~GUERBET~39.3
%;19.6%~N~018905~002~~Jul 26, 1985~Yes~RX~GUERBET LLC
DEXAMETHASONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~HEXADROL~ORGANON USA INC~EQ
4MG PHOSPHATE/ML~N~014694~002~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON US
A INC
10MG PHOSPHATE/ML~N~014694~003~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON U
SA INC
20MG PHOSPHATE/ML~N~014694~004~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON U
SA INC
IODOHIPPURATE SODIUM I-131~INJECTABLE;INJECTION~HIPPURAN I 131~MALLINCKRODT~0.25
mCi/ML~N~016666~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICAL
INC
IODOHIPPURATE SODIUM I-131~INJECTABLE;INJECTION~HIPPUTOPE~BRACCO~1-2mCi/VIAL~N~0
BETAZOLE HYDROCHLORIDE~INJECTABLE;INJECTION~HISTALOG~LILLY~50MG/ML~N~009344~001~
~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
HISTAMINE PHOSPHATE~INJECTABLE;INJECTION~HISTAMINE PHOSPHATE~LILLY~EQ 0.1MG BASE
/ML~N~000734~003~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
HISTAMINE PHOSPHATE~INJECTABLE;INJECTION~HISTAMINE PHOSPHATE~LILLY~EQ 0.2MG BASE
/ML~N~000734~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
HISTAMINE PHOSPHATE~INJECTABLE;INJECTION~HISTAMINE PHOSPHATE~LILLY~EQ 1MG BASE/M
L~N~000734~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
INSULIN LISPRO RECOMBINANT~INJECTABLE;INJECTION~HUMALOG~LILLY~100 UNITS/ML~N~020
563~001~~Jun 14, 1996~Yes~RX~ELI LILLY AND CO
INSULIN LISPRO RECOMBINANT~INJECTABLE;INJECTION~HUMALOG KWIKPEN~LILLY~100 UNITS/
ML~N~020563~003~~Sep 6, 2007~Yes~RX~ELI LILLY AND CO
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT~INJECTABLE;INJE
CTION~HUMALOG MIX 50/50~LILLY~50 UNITS/ML;50 UNITS/ML~N~021018~001~~Dec 22, 1999
~Yes~RX~ELI LILLY AND CO
CTION~HUMALOG MIX 50/50 KWIKPEN~LILLY~50 UNITS/ML;50 UNITS/ML~N~021018~002~~Sep
6, 2007~Yes~RX~ELI LILLY AND CO
CTION~HUMALOG MIX 50/50 PEN~LILLY~50 UNITS/ML;50 UNITS/ML~N~021018~003~~Dec 22,
CTION~HUMALOG MIX 75/25~LILLY~75 UNITS/ML;25 UNITS/ML~N~021017~001~~Dec 22, 1999
~Yes~RX~ELI LILLY AND CO
CTION~HUMALOG MIX 75/25 KWIKPEN~LILLY~75 UNITS/ML;25 UNITS/ML~N~021017~002~~Sep

CTION~HUMALOG MIX 75/25 PEN~LILLY~75 UNITS/ML;25 UNITS/ML~N~021017~003~~Dec 22,
INSULIN LISPRO RECOMBINANT~INJECTABLE;INJECTION~HUMALOG PEN~LILLY~100 UNITS/ML~N
~020563~002~~Aug 6, 1998~No~DISCN~ELI LILLY AND CO
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~HUMATROPE~LILLY~2MG/VIAL~N~019640~00
1~~Jun 23, 1987~No~DISCN~ELI LILLY AND CO
4~BX~Mar 8, 1987~Yes~RX~ELI LILLY AND CO
5~BX~Feb 4, 1999~No~RX~ELI LILLY AND CO
06~~Feb 4, 1999~Yes~RX~ELI LILLY AND CO
07~~Feb 4, 1999~Yes~RX~ELI LILLY AND CO
MENOTROPINS (FSH;LH)~INJECTABLE;INJECTION~HUMEGON~ORGANON USA INC~75 IU/VIAL;75
IU/VIAL~N~020328~001~~Sep 1, 1994~No~DISCN~ORGANON USA INC
MENOTROPINS (FSH;LH)~INJECTABLE;INJECTION~HUMEGON~ORGANON USA INC~150 IU/VIAL;15
0 IU/VIAL~N~020328~002~~Sep 1, 1994~No~DISCN~ORGANON USA INC
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN~INJECTABLE;IN
JECTION~HUMULIN 50/50~LILLY~50 UNITS/ML;50 UNITS/ML~N~020100~001~~Apr 29, 1992~N
o~DISCN~ELI LILLY AND CO
JECTION~HUMULIN 70/30~LILLY~30 UNITS/ML;70 UNITS/ML~N~019717~001~~Apr 25, 1989~Y
es~OTC~ELI LILLY AND CO
JECTION~HUMULIN 70/30 PEN~LILLY~30 UNITS/ML;70 UNITS/ML~N~019717~002~~Aug 6, 199
8~Yes~OTC~ELI LILLY AND CO
INSULIN RECOMBINANT HUMAN~INJECTABLE;INJECTION~HUMULIN BR~LILLY~100 UNITS/ML~N~0
19529~001~~Apr 28, 1986~No~DISCN~ELI LILLY AND CO
INSULIN ZINC SUSP RECOMBINANT HUMAN~INJECTABLE;INJECTION~HUMULIN L~LILLY~100 UNI
TS/ML~N~019377~002~~Sep 30, 1985~No~DISCN~ELI LILLY AND CO
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN~INJECTABLE;INJECTION~HUMULIN N~LILLY~100
UNITS/ML~N~018781~001~~Oct 28, 1982~Yes~OTC~ELI LILLY AND CO
INSULIN RECOMBINANT HUMAN~INJECTABLE;INJECTION~HUMULIN R~LILLY~100 UNITS/ML~N~01
8780~001~~Oct 28, 1982~Yes~OTC~ELI LILLY AND CO
INSULIN RECOMBINANT HUMAN~INJECTABLE;INJECTION~HUMULIN R~LILLY~500 UNITS/ML~N~01
8780~004~~Mar 31, 1994~Yes~RX~ELI LILLY AND CO
INSULIN RECOMBINANT HUMAN~INJECTABLE;INJECTION~HUMULIN R PEN~LILLY~100 UNITS/ML~
N~018780~005~~Aug 6, 1998~Yes~OTC~ELI LILLY AND CO
INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN~INJECTABLE;INJECTION~HUMULIN U~LILL
Y~40 UNITS/ML~N~019571~001~~Jun 10, 1987~No~DISCN~ELI LILLY AND CO
INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN~INJECTABLE;INJECTION~HUMULIN U~LILL
Y~100 UNITS/ML~N~019571~002~~Jun 10, 1987~No~DISCN~ELI LILLY AND CO
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~HYCAMTIN~GLAXOSMITHKLINE~EQ 4MG BAS
E/VIAL~N~020671~001~AP~May 28, 1996~Yes~RX~GLAXOSMITHKLINE
HYALURONIDASE~INJECTABLE;INJECTION~HYDASE~AKORN INC~150 UNITS/ML~N~021716~001~~O
ct 25, 2005~No~DISCN~AKORN INC
PREDNISOLONE TEBUTATE~INJECTABLE;INJECTION~HYDELTRA-TBA~MERCK~20MG/ML~N~010562~0
PREDNISOLONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~HYDELTRASOL~MERCK~EQ 20MG PHO
SPHATE/ML~N~011583~002~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDRALAZINE HYDROCHLORIDE~ABRAXIS
PHARM~20MG/ML~A~089532~001~~Aug 11, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUC
TS
HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDRALAZINE HYDROCHLORIDE~AKORN~2
0MG/ML~A~040730~001~AP~Apr 21, 2009~Yes~RX~AKORN INC
HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDRALAZINE HYDROCHLORIDE~FRESENI
US KABI USA~20MG/ML~A~040388~001~AP~Mar 13, 2001~No~RX~FRESENIUS KABI USA LLC

HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDRALAZINE HYDROCHLORIDE~LUITPOL
D~20MG/ML~A~040136~001~AP~Jun 30, 1997~No~RX~LUITPOLD PHARMACEUTICALS INC
HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDRALAZINE HYDROCHLORIDE~NAVINTA
LLC~20MG/ML~A~202938~001~AP~Mar 28, 2013~No~RX~NAVINTA LLC
HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDRALAZINE HYDROCHLORIDE~SMITH A
ND NEPHEW~20MG/ML~A~088518~001~~Apr 20, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK D
IV SMITH AND NEPHEW
HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDRALAZINE HYDROCHLORIDE~SOLOPAK
~20MG/ML~A~088517~001~~Aug 22, 1985~No~DISCN~SOLOPAK LABORATORIES INC
HYDRALAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDRALAZINE HYDROCHLORIDE~TEVA PA
RENTERAL~20MG/ML~A~040373~001~~Feb 23, 2000~No~DISCN~TEVA PARENTERAL MEDICINES I
NC
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~HYDROCORTISONE ACETATE~AKORN~25MG/ML
~N~009637~001~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~HYDROCORTISONE ACETATE~AKORN~50MG/ML
~N~009637~002~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~HYDROCORTISONE ACETATE~BEL MAR~25MG/
ML~A~083739~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~HYDROCORTISONE ACETATE~BEL MAR~50MG/
ML~A~083739~002~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~HYDROCORTISONE ACETATE~WATSON LABS~2
5MG/ML~A~083128~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES
INC
INC
INC
INC
HYDROCORTISONE SODIUM SUCCINATE~INJECTABLE;INJECTION~HYDROCORTISONE SODIUM SUCCI
NATE~ABRAXIS PHARM~EQ 1GM BASE/VIAL~A~088670~001~~Jun 8, 1984~No~DISCN~ABRAXIS P
HARMACEUTICAL PRODUCTS
NATE~ABRAXIS PHARM~EQ 100MG BASE/VIAL~A~088667~001~~Jun 8, 1984~No~DISCN~ABRAXIS
PHARMACEUTICAL PRODUCTS
NATE~BAXTER HLTHCARE~EQ 1GM BASE/VIAL~A~087569~001~~Approved Prior to Jan 1, 198
2~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
NATE~BAXTER HLTHCARE~EQ 100MG BASE/VIAL~A~086619~001~~Approved Prior to Jan 1, 1

NATE~INTL MEDICATION~EQ 100MG BASE/VIAL~A~087532~001~~Mar 19, 1982~No~DISCN~INTE
RNATIONAL MEDICATION SYSTEMS LTD
NATE~WATSON LABS~EQ 1GM BASE/VIAL~A~084748~001~~Approved Prior to Jan 1, 1982~No
NATE~WATSON LABS~EQ 100MG BASE/VIAL~A~084737~002~~Approved Prior to Jan 1, 1982~
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~HYDROCORTONE~MERCK~25MG/ML~N~008228~
HYDROCORTISONE ACETATE~INJECTABLE;INJECTION~HYDROCORTONE~MERCK~50MG/ML~N~008228~
HYDROCORTISONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~HYDROCORTONE~MERCK~EQ 50MG
BASE/ML~N~012052~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
HYDROMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROMORPHONE HYDROCHLORIDE~AKO
RN~10MG/ML~A~078228~001~AP~Apr 14, 2010~No~RX~AKORN INC
HYDROMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROMORPHONE HYDROCHLORIDE~AKO
RN~10MG/ML~A~078261~001~AP~Apr 14, 2010~No~RX~AKORN INC
HYDROMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROMORPHONE HYDROCHLORIDE~BAR
R~10MG/ML~A~076444~001~AP~Apr 25, 2003~No~RX~BARR LABORATORIES INC
HYDROMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROMORPHONE HYDROCHLORIDE~HOS
PIRA~10MG/ML~A~074598~001~AP~Jun 19, 1997~No~RX~HOSPIRA INC
PIRA INC~1MG/ML~N~200403~001~AP~Dec 1, 2011~No~RX~HOSPIRA INC
PIRA INC~10MG/ML~A~078591~001~AP~Jun 17, 2008~No~RX~HOSPIRA INC
HYDROMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROMORPHONE HYDROCHLORIDE~WAT
SON LABS~10MG/ML~A~074317~001~~Aug 23, 1995~No~DISCN~WATSON LABORATORIES INC
HYDROXOCOBALAMIN~INJECTABLE;INJECTION~HYDROXOCOBALAMIN~ABRAXIS PHARM~1MG/ML~A~08
HYDROXOCOBALAMIN~INJECTABLE;INJECTION~HYDROXOCOBALAMIN~WATSON LABS~1MG/ML~A~0855
HYDROXOCOBALAMIN~INJECTABLE;INJECTION~HYDROXOCOBALAMIN~WATSON LABS~1MG/ML~A~0859
98~001~~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
HYDROXOCOBALAMIN~INJECTABLE;INJECTION~HYDROXOMIN~BEL MAR~1MG/ML~A~084629~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
HYDROXYPROGESTERONE CAPROATE~INJECTABLE;INJECTION~HYDROXYPROGESTERONE CAPROATE~A
KORN~125MG/ML~N~018004~001~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
HYDROXYPROGESTERONE CAPROATE~INJECTABLE;INJECTION~HYDROXYPROGESTERONE CAPROATE~W
ATSON LABS~125MG/ML~N~017439~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON
LABORATORIES INC
HYDROXYPROGESTERONE CAPROATE~INJECTABLE;INJECTION~HYDROXYPROGESTERONE CAPROATE~W
ATSON LABS~250MG/ML~N~017439~002~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON
LABORATORIES INC
HYDROXYSTILBAMIDINE ISETHIONATE~INJECTABLE;INJECTION~HYDROXYSTILBAMIDINE ISETHIO
NATE~SANOFI AVENTIS US~225MG/AMP~N~009166~001~~Approved Prior to Jan 1, 1982~No~
DISCN~SANOFI AVENTIS US LLC

HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE~BAXTER HLTHCARE~50MG/
ML~A~085551~002~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP A
NESTHESIA AND CRITICAL CARE
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~ALTANA~
25MG/ML~A~087273~001~~Apr 20, 1982~No~DISCN~ALTANA INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~ALTANA~
50MG/ML~A~087273~002~~Apr 20, 1982~No~DISCN~ALTANA INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~BAXTER
HLTHCARE~25MG/ML~A~085551~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEA
LTHCARE CORP ANESTHESIA AND CRITICAL CARE
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~FRESENI
US KABI USA~25MG/ML~A~087329~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENI
US KABI USA LLC
US KABI USA~25MG/ML~A~088184~001~~Mar 31, 1983~No~DISCN~FRESENIUS KABI USA LLC
US KABI USA~50MG/ML~A~087329~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENI
US KABI USA LLC
US KABI USA~50MG/ML~A~088185~001~~Mar 31, 1983~No~DISCN~FRESENIUS KABI USA LLC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~HOSPIRA
~25MG/ML~A~087416~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~LUITPOL
D~25MG/ML~A~087408~001~AP~Approved Prior to Jan 1, 1982~No~RX~LUITPOLD PHARMACEU
TICALS INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~LUITPOL
D~50MG/ML~A~087408~002~AP~Approved Prior to Jan 1, 1982~No~RX~LUITPOLD PHARMACEU
TICALS INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~PHARMAF
AIR~25MG/ML~A~088862~001~~Feb 14, 1986~No~DISCN~PHARMAFAIR INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~SMITH A
ND NEPHEW~25MG/ML~A~087592~001~~Approved Prior to Jan 1, 1982~No~DISCN~SMITH AND
NEPHEW SOLOPAK DIV SMITH AND NEPHEW
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~SOLOPAK
~25MG/ML~A~086822~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLOPAK MEDICAL PR
ODUCTS INC
~25MG/ML~A~087591~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLOPAK LABORATORI
ES INC
ODUCTS INC
ES INC
ES INC

ODUCTS INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~WATSON
LABS~25MG/ML~A~085778~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORAT
ORIES INC
ORIES INC
ORIES INC
ORIES INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~WYETH A
YERST~25MG/ML~A~086258~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST
LABORATORIES
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~HYDROXYZINE HYDROCHLORIDE~WYETH A
YERST~50MG/ML~A~086258~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST
LABORATORIES
HYALURONIDASE RECOMBINANT HUMAN~INJECTABLE;INJECTION~HYLENEX RECOMBINANT~HALOZYM
E THERAP~150 UNITS/ML~N~021859~001~~Dec 2, 2005~Yes~RX~HALOZYME THERAPEUTICS INC
DIATRIZOATE SODIUM~INJECTABLE;INJECTION~HYPAQUE~GE HEALTHCARE~25%~N~009561~003~~
DIATRIZOATE MEGLUMINE~INJECTABLE;INJECTION~HYPAQUE~GE HEALTHCARE~30%~N~016403~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
DIATRIZOATE SODIUM~INJECTABLE;INJECTION~HYPAQUE~GE HEALTHCARE~50%~N~009561~001~~
DIATRIZOATE MEGLUMINE~INJECTABLE;INJECTION~HYPAQUE~GE HEALTHCARE~60%~N~016403~00
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~HYPAQUE-76~GE HEA
LTHCARE~66%;10%~A~086505~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCA
RE
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~HYPAQUE-M,75%~GE
HEALTHCARE~50%;25%~N~010220~003~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALT
HCARE
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~HYPAQUE-M,90%~GE
HEALTHCARE~60%;30%~N~010220~002~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALT
HCARE
DIAZOXIDE~INJECTABLE;INJECTION~HYPERSTAT~SCHERING~15MG/ML~N~016996~001~~Approved
Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
PROTEIN HYDROLYSATE~INJECTABLE;INJECTION~HYPROTIGEN 5%~B BRAUN~5%~N~006170~003~~
Jan 10, 1984~No~DISCN~B BRAUN MEDICAL INC
FIBRINOGEN, I-125~INJECTABLE;INJECTION~IBRIN~GE HEALTHCARE~154uCi/VIAL~N~017879~
IBUTILIDE FUMARATE~INJECTABLE;INJECTION~IBUTILIDE FUMARATE~LUITPOLD~0.1MG/ML~A~0
90240~001~AP~Jan 11, 2010~No~RX~LUITPOLD PHARMACEUTICALS INC
IBUTILIDE FUMARATE~INJECTABLE;INJECTION~IBUTILIDE FUMARATE~MYLAN INSTITUTIONAL~0
.1MG/ML~A~090643~001~AP~Jan 11, 2010~No~RX~MYLAN INSTITUTIONAL LLC
IBUTILIDE FUMARATE~INJECTABLE;INJECTION~IBUTILIDE FUMARATE~MYLAN INSTITUTIONAL~0
.1MG/ML~A~090924~001~AP~Jan 11, 2010~No~RX~MYLAN INSTITUTIONAL LLC
INDOCYANINE GREEN~INJECTABLE;INJECTION~IC-GREEN~AKORN~10MG/VIAL~N~011525~003~~Ap
proved Prior to Jan 1, 1982~No~DISCN~AKORN INC
INDOCYANINE GREEN~INJECTABLE;INJECTION~IC-GREEN~AKORN~25MG/VIAL~N~011525~001~AP~
Approved Prior to Jan 1, 1982~Yes~RX~AKORN INC
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDAMYCIN~PHARMACIA AND UPJOHN~5MG/
VIAL~N~050661~002~~Sep 27, 1990~No~DISCN~PHARMACIA AND UPJOHN CO

IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDAMYCIN~PHARMACIA AND UPJOHN~10MG
/VIAL~N~050661~001~~Sep 27, 1990~No~DISCN~PHARMACIA AND UPJOHN CO
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDAMYCIN~PHARMACIA AND UPJOHN~20MG
/VIAL~N~050661~003~~Apr 25, 1995~No~DISCN~PHARMACIA AND UPJOHN CO
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDAMYCIN PFS~PHARMACIA AND UPJOHN~
1MG/ML~N~050734~001~AP~Feb 17, 1997~Yes~RX~PHARMACIA AND UPJOHN CO
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDARUBICIN HYDROCHLORIDE~EUROHLTH
INTL SARL~1MG/ML~A~065275~001~AP~Dec 14, 2006~No~RX~EUROHEALTH INTERNATIONAL SAR
L
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDARUBICIN HYDROCHLORIDE~EUROHLTH
INTL SARL~1MG/ML~A~065288~001~AP~May 15, 2007~No~RX~EUROHEALTH INTERNATIONAL SAR
L
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDARUBICIN HYDROCHLORIDE~FRESENIUS
KABI USA~1MG/ML~A~065440~001~AP~Aug 4, 2009~No~RX~FRESENIUS KABI USA LLC
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDARUBICIN HYDROCHLORIDE~ONCO THER
APIES LTD~1MG/ML~A~200144~001~AP~Oct 11, 2012~No~RX~ONCO THERAPIES LTD
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDARUBICIN HYDROCHLORIDE~SANDOZ~1M
G/ML~A~091293~001~~Mar 29, 2011~No~DISCN~SANDOZ INC
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDARUBICIN HYDROCHLORIDE~TEVA PARE
NTERAL~5MG/VIAL~A~065037~003~~May 1, 2002~No~DISCN~TEVA PARENTERAL MEDICINES INC
NTERAL~10MG/VIAL~A~065037~002~~May 1, 2002~No~DISCN~TEVA PARENTERAL MEDICINES IN
C
NTERAL~20MG/VIAL~A~065037~001~~May 1, 2002~No~DISCN~TEVA PARENTERAL MEDICINES IN
C
IDARUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~IDARUBICIN HYDROCHLORIDE PFS~TEVA
PHARMS USA~1MG/ML~A~065036~001~AP~May 1, 2002~No~RX~TEVA PHARMACEUTICALS USA
IFOSFAMIDE~INJECTABLE;INJECTION~IFEX~BAXTER HLTHCARE~1GM/VIAL~N~019763~001~AP~De
c 30, 1988~No~RX~BAXTER HEALTHCARE CORP
IFOSFAMIDE~INJECTABLE;INJECTION~IFEX~BAXTER HLTHCARE~3GM/VIAL~N~019763~002~AP~De
c 30, 1988~No~RX~BAXTER HEALTHCARE CORP
IFOSFAMIDE; MESNA~INJECTABLE;INJECTION~IFEX/MESNEX KIT~BAXTER HLTHCARE~1GM/VIAL;
100MG/ML~N~019763~003~~Oct 10, 1992~No~DISCN~BAXTER HEALTHCARE CORP
IFOSFAMIDE; MESNA~INJECTABLE;INJECTION~IFEX/MESNEX KIT~BAXTER HLTHCARE~3GM/VIAL;
100MG/ML~N~019763~004~~Oct 10, 1992~No~DISCN~BAXTER HEALTHCARE CORP
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~EUROHLTH INTL SARL~1GM/20ML(50MG/ML)~
A~076619~001~AP~Jun 29, 2011~No~RX~EUROHEALTH INTERNATIONAL SARL
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~EUROHLTH INTL SARL~3GM/60ML(50MG/ML)~
A~076619~002~AP~Jun 29, 2011~No~RX~EUROHEALTH INTERNATIONAL SARL
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~FRESENIUS KABI USA~1GM/VIAL~A~076078~
001~AP~May 28, 2002~Yes~RX~FRESENIUS KABI USA LLC
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~FRESENIUS KABI USA~1GM/20ML (50MG/ML)
~A~090181~001~AP~Sep 22, 2009~No~RX~FRESENIUS KABI USA LLC
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~FRESENIUS KABI USA~3GM/VIAL~A~076078~
002~AP~May 28, 2002~Yes~RX~FRESENIUS KABI USA LLC
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~FRESENIUS KABI USA~3GM/60ML (50MG/ML)
~A~090181~002~AP~Sep 22, 2009~No~RX~FRESENIUS KABI USA LLC
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~ONCO THERAPIES LTD~1GM/20ML (50MG/ML)
~A~201689~001~AP~Nov 26, 2012~No~RX~ONCO THERAPIES LTD
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~ONCO THERAPIES LTD~3GM/60ML (50MG/ML)
~A~201689~002~AP~Nov 26, 2012~No~RX~ONCO THERAPIES LTD
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~TEVA PHARMS USA~1GM/20ML (50MG/ML)~A~
076657~001~AP~Apr 4, 2007~Yes~RX~TEVA PHARMACEUTICALS USA
IFOSFAMIDE~INJECTABLE;INJECTION~IFOSFAMIDE~TEVA PHARMS USA~3GM/60ML (50MG/ML)~A~
076657~002~AP~Apr 4, 2007~Yes~RX~TEVA PHARMACEUTICALS USA
INSULIN PORK~INJECTABLE;INJECTION~ILETIN I~LILLY~500 UNITS/ML~N~017931~001~~Appr
INSULIN PURIFIED PORK~INJECTABLE;INJECTION~ILETIN II~LILLY~500 UNITS/ML~N~018344

ERYTHROMYCIN GLUCEPTATE~INJECTABLE;INJECTION~ILOTYCIN GLUCEPTATE~DISTA~EQ 1GM BA
SE/VIAL~N~050370~003~~Approved Prior to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO D
IV ELI LILLY AND CO
ERYTHROMYCIN GLUCEPTATE~INJECTABLE;INJECTION~ILOTYCIN GLUCEPTATE~DISTA~EQ 250MG
BASE/VIAL~N~050370~001~~Approved Prior to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO
DIV ELI LILLY AND CO
ERYTHROMYCIN GLUCEPTATE~INJECTABLE;INJECTION~ILOTYCIN GLUCEPTATE~DISTA~EQ 500MG
BASE/VIAL~N~050370~002~~Approved Prior to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO
DIV ELI LILLY AND CO
AZATHIOPRINE SODIUM~INJECTABLE;INJECTION~IMURAN~PROMETHEUS LABS~EQ 100MG BASE/VI
AL~N~017391~001~~Approved Prior to Jan 1, 1982~No~DISCN~PROMETHEUS LABORATORIES
INC
DROPERIDOL~INJECTABLE;INJECTION~INAPSINE~AKORN INC~2.5MG/ML~N~016796~001~AP~Appr
oved Prior to Jan 1, 1982~Yes~RX~AKORN INC
INDIUM IN-111 CHLORIDE~INJECTABLE;INJECTION~INDICLOR~GE HEALTHCARE~2mCi/0.2ML~N~
019862~001~~Dec 29, 1992~Yes~RX~GE HEALTHCARE
INDIUM IN-111 CHLORIDE~INJECTABLE;INJECTION~INDIUM IN 111 CHLORIDE~MALLINCKRODT~
5mCi/0.5ML~N~019841~001~~Sep 27, 1994~Yes~RX~MALLINCKRODT MEDICAL INC
INDIUM IN-111 OXYQUINOLINE~INJECTABLE;INJECTION~INDIUM IN-111 OXYQUINOLINE~GE HE
ALTHCARE~1mCi/ML~N~019044~001~~Dec 24, 1985~Yes~RX~GE HEALTHCARE
INDOMETHACIN SODIUM~INJECTABLE;INJECTION~INDOCIN~RECORDATI RARE~EQ 1MG BASE/VIAL
~N~018878~001~AP~Jan 30, 1985~Yes~RX~RECORDATI RARE DISEASES INC
INDOCYANINE GREEN~INJECTABLE;INJECTION~INDOCYANINE GREEN~PULSION MEDCL~25MG/VIAL
~A~040811~001~AP~Nov 21, 2007~No~RX~PULSION MEDICAL SYSTEMS AG
INDOMETHACIN~INJECTABLE;INJECTION~INDOMETHACIN~FRESENIUS KABI USA~EQ 1MG BASE/VI
AL~N~022536~001~~Mar 17, 2010~Yes~RX~FRESENIUS KABI USA LLC
INDOMETHACIN SODIUM~INJECTABLE;INJECTION~INDOMETHACIN SODIUM~EUROHLTH INTL SARL~
EQ 1MG BASE/VIAL~A~078713~001~AP~Jul 16, 2008~No~RX~EUROHEALTH INTERNATIONAL SAR
L
IRON DEXTRAN~INJECTABLE;INJECTION~INFED~WATSON LABS (UTAH)~EQ 50MG IRON/ML~N~017
441~001~BP~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
MORPHINE SULFATE~INJECTABLE;INJECTION~INFUMORPH~HIKMA MAPLE ~10MG/ML~N~018565~00
3~~Jul 19, 1991~Yes~RX~HIKMA MAPLE LTD
MORPHINE SULFATE~INJECTABLE;INJECTION~INFUMORPH~HIKMA MAPLE ~25MG/ML~N~018565~00
4~~Jul 19, 1991~Yes~RX~HIKMA MAPLE LTD
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~INJECT
ABLE;INJECTION~INFUVITE ADULT~SANDOZ~2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3
MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML~N~021163~
001~~May 18, 2000~Yes~RX~SANDOZ CANADA INC
ACETAMINOPHEN~INJECTABLE;INJECTION~INJECTAPAP~ORTHO MCNEIL PHARM~100MG/ML~N~0177
85~001~~Mar 7, 1986~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
TINZAPARIN SODIUM~INJECTABLE;INJECTION~INNOHEP~LEO PHARMA AS~20,000 IU/ML~N~0204
84~001~~Jul 14, 2000~No~DISCN~LEO PHARMA AS
DROPERIDOL; FENTANYL CITRATE~INJECTABLE;INJECTION~INNOVAR~AKORN MFG~2.5MG/ML;EQ
0.05MG BASE/ML~N~016049~001~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN MANUFA
CTURING INC
INAMRINONE LACTATE~INJECTABLE;INJECTION~INOCOR~SANOFI AVENTIS US~EQ 5MG BASE/ML~
N~018700~001~~Jul 31, 1984~No~DISCN~SANOFI AVENTIS US LLC
TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT~INJECTABLE;INJECTION~INSTANT MICROSPH
ERES~3M~N/A~N~017832~001~~Approved Prior to Jan 1, 1982~No~DISCN~3M MEDICAL PROD
UCTS DIV
INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN~INJECTABLE;INJECTION~INSULATA
RD NPH HUMAN~NOVO NORDISK INC~100 UNITS/ML~N~019449~001~~May 30, 1986~No~DISCN~N
OVO NORDISK INC
INSULIN PORK~INJECTABLE;INJECTION~INSULIN~NOVO NORDISK INC~40 UNITS/ML~N~017926~
001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NORDISK INC
INSULIN SUSP ISOPHANE PURIFIED PORK~INJECTABLE;INJECTION~INSULIN INSULATARD NPH
NORDISK~NOVO NORDISK INC~100 UNITS/ML~N~018194~001~~Approved Prior to Jan 1, 198

2~No~DISCN~NOVO NORDISK INC
INSULIN PURIFIED PORK; INSULIN SUSP ISOPHANE PURIFIED PORK~INJECTABLE;INJECTION~
INSULIN NORDISK MIXTARD (PORK)~NOVO NORDISK INC~30 UNITS/ML;70 UNITS/ML~N~018195
~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NORDISK INC
EPTIFIBATIDE~INJECTABLE;INJECTION~INTEGRILIN~SCHERING~2MG/ML~N~020718~001~~May 1
8, 1998~Yes~RX~SCHERING CORP
EPTIFIBATIDE~INJECTABLE;INJECTION~INTEGRILIN~SCHERING~75MG/100ML~N~020718~002~~M
ay 18, 1998~Yes~RX~SCHERING CORP
SOYBEAN OIL~INJECTABLE;INJECTION~INTRALIPID 10%~FRESENIUS~10%~N~017643~001~AP~Ap
proved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI DEUTSCHLAND GMBH
SOYBEAN OIL~INJECTABLE;INJECTION~INTRALIPID 20%~FRESENIUS~20%~N~018449~001~AP~Ap
proved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI DEUTSCHLAND GMBH
SOYBEAN OIL~INJECTABLE;INJECTION~INTRALIPID 20%~FRESENIUS~20%~N~020248~001~AP~Au
g 7, 1996~Yes~RX~FRESENIUS KABI DEUTSCHLAND GMBH
SOYBEAN OIL~INJECTABLE;INJECTION~INTRALIPID 30%~FRESENIUS~30%~N~019942~001~AP~De
c 30, 1993~Yes~RX~FRESENIUS KABI DEUTSCHLAND GMBH
DOPAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~INTROPIN~HOSPIRA~40MG/ML~N~017395~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
INULIN~INJECTABLE;INJECTION~INULIN AND SODIUM CHLORIDE~ISO TEX~100MG/ML~N~002282
~001~~Approved Prior to Jan 1, 1982~No~DISCN~ISO TEX DIAGNOSTICS INC
IOBENGUANE SULFATE I-131~INJECTABLE;INJECTION~IOBENGUANE SULFATE I 131~PHARMALUC
ENCE~2.3mCi/ML~N~020084~001~~Mar 25, 1994~No~DISCN~PHARMALUCENCE INC
IODOHIPPURATE SODIUM I-131~INJECTABLE;INJECTION~IODOHIPPURATE SODIUM I 131~PHARM
ALUCENCE~0.2mCi/ML~N~017313~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMALU
CENCE INC
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;
SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS~INJECTABL
E;INJECTION~IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;53M
G/100ML;100MG/100ML;100MG/100ML;180MG/100ML;280MG/100ML;16MG/100ML~N~019515~001~
~May 8, 1986~No~RX~HOSPIRA INC
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC
; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS~INJECTABLE;INJECTION~ION
OSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;30MG/100ML;141MG/
100ML;15MG/100ML;260MG/100ML;25MG/100ML~N~019513~001~~May 8, 1986~No~RX~HOSPIRA
INC
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHA
TE, MONOBASIC ANHYDROUS~INJECTABLE;INJECTION~IONOSOL T AND DEXTROSE 5% IN PLASTI
C CONTAINER~HOSPIRA~5GM/100ML;111MG/100ML;256MG/100ML;146MG/100ML;207MG/100ML~N~
019514~001~~May 8, 1986~No~DISCN~HOSPIRA WORLDWIDE, INC
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL~BAXTER HLTHCARE~41%~A~074629~001~~Nov 6
, 1996~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL~BAXTER HLTHCARE~51%~A~074629~004~~Mar 3
1, 1998~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL~HOSPIRA~61%~A~074734~001~~Dec 10, 1996~
No~DISCN~HOSPIRA INC
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL~HOSPIRA~76%~A~074734~002~~Dec 10, 1996~
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL-200~COOK IMAGING~41%~A~074881~001~~Jul
28, 2000~No~DISCN~COOK IMAGING CORP
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL-200~HOSPIRA~41%~A~074898~001~~Dec 30, 1
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL-200 IN PLASTIC CONTAINER~HOSPIRA~41%~A~

074636~001~~Dec 30, 1997~No~DISCN~HOSPIRA WORLDWIDE, INC
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL-250~FRESENIUS KABI USA~51%~A~074679~001
~~Apr 2, 1997~No~DISCN~FRESENIUS KABI USA LLC
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL-250~HOSPIRA~51%~A~075005~001~~Feb 24, 1
IOPAMIDOL~INJECTABLE;INJECTION~IOPAMIDOL-300~ABBVIE~61%~A~074638~001~~Apr 30, 19
074637~001~~Apr 3, 1997~No~DISCN~HOSPIRA WORLDWIDE, INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~ACCORD HL
THCARE~40MG/2ML (20MG/ML)~A~079068~001~AP~Nov 21, 2008~No~RX~ACCORD HEALTHCARE I
NC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~ACCORD HL
THCARE~100MG/5ML (20MG/ML)~A~079068~002~AP~Nov 21, 2008~No~RX~ACCORD HEALTHCARE
INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~ACTAVIS T
OTOWA~40MG/2ML (20MG/ML)~A~078589~001~AP~Feb 27, 2008~No~RX~ACTAVIS TOTOWA LLC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~ACTAVIS T
OTOWA~100MG/5ML (20MG/ML)~A~078589~002~AP~Feb 27, 2008~No~RX~ACTAVIS TOTOWA LLC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~AKORN~40M
G/2ML (20MG/ML)~A~090726~001~AP~Sep 16, 2009~No~RX~AKORN INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~AKORN~100
MG/5ML (20MG/ML)~A~090726~002~AP~Sep 16, 2009~No~RX~AKORN INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~BEDFORD L
ABS~40MG/2ML (20MG/ML)~A~078753~001~AP~Dec 24, 2008~No~RX~BEDFORD LABORATORIES
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~BEDFORD L
ABS~100MG/5ML (20MG/ML)~A~078753~002~AP~Dec 24, 2008~No~RX~BEDFORD LABORATORIES
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~CIPLA LTD
~40MG/2ML (20MG/ML)~A~077219~001~AP~Feb 20, 2008~No~RX~CIPLA LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~CIPLA LTD
~100MG/5ML (20MG/ML)~A~077219~002~AP~Feb 20, 2008~No~RX~CIPLA LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~DR REDDYS
LABS LTD~40MG/2ML (20MG/ML)~A~078953~001~AP~Apr 15, 2010~No~RX~DR REDDYS LABORA
TORIES LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~DR REDDYS
LABS LTD~100MG/5ML (20MG/ML)~A~078953~002~AP~Apr 15, 2010~No~RX~DR REDDYS LABOR
ATORIES LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~EBEWE PHA
RMA~40MG/2ML (20MG/ML)~A~090137~001~AP~Nov 12, 2009~No~RX~EBEWE PHARMA GES MBH N
FG KG
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~EBEWE PHA
RMA~100MG/5ML (20MG/ML)~A~090137~002~AP~Nov 12, 2009~No~RX~EBEWE PHARMA GES MBH
NFG KG
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~EMCURE PH
ARMS LTD~40MG/2ML (20MG/ML)~A~200771~001~AP~Feb 14, 2012~No~RX~EMCURE PHARMACEUT
ICALS LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~EMCURE PH
ARMS LTD~100MG/5ML (20MG/ML)~A~200771~002~AP~Feb 14, 2012~No~RX~EMCURE PHARMACEU
TICALS LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~FRESENIUS
KABI ONCOL~40MG/2ML (20MG/ML)~A~078188~001~AP~Feb 27, 2008~No~RX~FRESENIUS KABI
ONCOLOGY PLC
KABI ONCOL~100MG/5ML (20MG/ML)~A~078188~002~AP~Feb 27, 2008~No~RX~FRESENIUS KAB
I ONCOLOGY PLC
KABI USA~40MG/2ML (20MG/ML)~A~077776~001~AP~Feb 27, 2008~No~RX~FRESENIUS KABI U
SA LLC
KABI USA~100MG/5ML (20MG/ML)~A~077776~002~AP~Feb 27, 2008~No~RX~FRESENIUS KABI
USA LLC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~HIKMA FAR
MACEUTICA~40MG/2ML (20MG/ML)~A~091032~001~AP~Dec 20, 2010~No~RX~HIKMA FARMACEUTI
CA (PORTUGAL) SA
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~HIKMA FAR
MACEUTICA~100MG/5ML (20MG/ML)~A~091032~002~AP~Dec 20, 2010~No~RX~HIKMA FARMACEUT
ICA (PORTUGAL) SA
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~HISUN PHA
RM HANGZHOU~40MG/2ML (20MG/ML)~A~090016~001~AP~Jan 28, 2009~No~RX~HISUN PHARMACE
UTICAL (HANGZHOU) CO LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~HISUN PHA
RM HANGZHOU~100MG/5ML (20MG/ML)~A~090016~002~AP~Jan 28, 2009~No~RX~HISUN PHARMAC
EUTICAL (HANGZHOU) CO LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~HOSPIRA~4
0MG/2ML (20MG/ML)~A~077915~001~AP~Feb 27, 2008~No~RX~HOSPIRA INC
00MG/5ML (20MG/ML)~A~077915~002~AP~Feb 27, 2008~No~RX~HOSPIRA INC
00MG/25ML (20MG/ML)~A~078796~001~AP~Feb 27, 2008~Yes~RX~HOSPIRA INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~JIANGSU H
ENGRUI MED~40MG/2ML (20MG/ML)~A~090675~002~AP~Dec 16, 2011~No~RX~JIANGSU HENGRUI
MEDICINE CO LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~JIANGSU H
ENGRUI MED~100MG/5ML (20MG/ML)~A~090675~001~AP~Dec 16, 2011~No~RX~JIANGSU HENGRU
I MEDICINE CO LTD
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~MUSTAFA N
EVZAT ILAC~40MG/2ML (20MG/ML)~A~090393~002~AP~May 13, 2011~No~RX~MUSTAFA NEVZAT
ILAC SANAYII AS (MN PHARMACEUTICALS)
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~MUSTAFA N
EVZAT ILAC~100MG/5ML (20MG/ML)~A~090393~003~AP~May 13, 2011~No~RX~MUSTAFA NEVZAT
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~PLIVA LAC
HEMA~40MG/2ML (20MG/ML)~A~078122~001~AP~Oct 31, 2008~No~RX~PLIVA LACHEMA AS
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~PLIVA LAC

HEMA~100MG/5ML (20MG/ML)~A~078122~002~AP~Oct 31, 2008~No~RX~PLIVA LACHEMA AS
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~SANDOZ~40
MG/2ML (20MG/ML)~A~077994~001~~Feb 27, 2008~No~DISCN~SANDOZ INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~SANDOZ~10
0MG/5ML (20MG/ML)~A~077994~002~~Feb 27, 2008~No~DISCN~SANDOZ INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~SUN PHARM
A GLOBAL~40MG/2ML (20MG/ML)~A~078805~001~AP~Apr 21, 2008~No~RX~SUN PHARMA GLOBAL
INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~SUN PHARM
A GLOBAL~100MG/5ML (20MG/ML)~A~078805~002~AP~Apr 21, 2008~No~RX~SUN PHARMA GLOBA
L INC
IRINOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~IRINOTECAN HYDROCHLORIDE~TEVA PHAR
MS USA~40MG/2ML (20MG/ML)~A~090101~002~AP~Feb 27, 2008~No~RX~TEVA PHARMACEUTICAL
S USA
MS USA~100MG/5ML (20MG/ML)~A~090101~003~AP~Feb 27, 2008~No~RX~TEVA PHARMACEUTICA
LS USA
MS USA~500MG/25ML (20MG/ML)~A~090101~001~AP~Nov 26, 2008~No~RX~TEVA PHARMACEUTIC
ALS USA
IRON DEXTRAN~INJECTABLE;INJECTION~IRON DEXTRAN~SANOFI AVENTIS US~EQ 50MG IRON/ML
~N~010787~002~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ISOCAINE HYDROCHLORIDE~NOVOCOL~3%
~A~080925~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~NOVOCOL PHARMACEUTICAL INC
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ISOCAINE HYDROCHLO
RIDE W/ LEVONORDEFRIN~NOVOCOL~0.05MG/ML;2%~A~084697~001~~Approved Prior to Jan 1
, 1982~No~DISCN~NOVOCOL PHARMACEUTICAL INC
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETA
TE; SODIUM CHLORIDE; SODIUM CITRATE~INJECTABLE;INJECTION~ISOLYTE E IN DEXTROSE 5
% IN PLASTIC CONTAINER~B BRAUN~35MG/100ML;5GM/100ML;30MG/100ML;74MG/100ML;640MG/
100ML;500MG/100ML;74MG/100ML~N~019867~001~~Dec 20, 1993~No~DISCN~B BRAUN MEDICAL
INC
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/100ML;500MG/100ML;74MG/100ML~N~0188
99~001~~Oct 31, 1983~No~DISCN~B BRAUN MEDICAL INC
CHLORIDE; SODIUM CITRATE~INJECTABLE;INJECTION~ISOLYTE E IN PLASTIC CONTAINER~B
BRAUN~35MG/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/100ML~N~0197
18~001~~Sep 29, 1989~Yes~RX~B BRAUN MEDICAL INC
TE; SODIUM CHLORIDE; SODIUM CITRATE~INJECTABLE;INJECTION~ISOLYTE E W/ DEXTROSE 5
% IN PLASTIC CONTAINER~B BRAUN~35MG/100ML;5GM/100ML;30MG/100ML;74MG/100ML;640MG/
100ML;500MG/100ML;74MG/100ML~N~018269~002~~Jan 17, 1983~No~DISCN~B BRAUN MEDICAL
INC
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORID
E~INJECTABLE;INJECTION~ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM
/100ML;30MG/100ML;97MG/100ML;220MG/100ML;140MG/100ML~N~019844~001~~Jun 10, 1993~
No~RX~B BRAUN MEDICAL INC
E~INJECTABLE;INJECTION~ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM
/100ML;30MG/100ML;97MG/100ML;220MG/100ML;140MG/100ML~N~018273~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODI
UM CHLORIDE~INJECTABLE;INJECTION~ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER~B
BRAUN~5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML~N~019870~001~~Ju
n 10, 1993~No~RX~B BRAUN MEDICAL INC
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODI
UM CHLORIDE~INJECTABLE;INJECTION~ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER~B
BRAUN~5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML~N~018270~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
SODIUM ACETATE~INJECTABLE;INJECTION~ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINE
R~B BRAUN~5GM/100ML;31MG/100ML;130MG/100ML;26MG/100ML;320MG/100ML~N~019873~001~~
Jun 10, 1993~No~RX~B BRAUN MEDICAL INC
SODIUM ACETATE~INJECTABLE;INJECTION~ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINE
R~B BRAUN~5GM/100ML;31MG/100ML;130MG/100ML;26MG/100ML;320MG/100ML~N~019025~001~~
Dec 27, 1984~No~DISCN~B BRAUN MEDICAL INC
TE; SODIUM CHLORIDE~INJECTABLE;INJECTION~ISOLYTE R IN DEXTROSE 5% IN PLASTIC CON
TAINER~B BRAUN~37MG/100ML;5GM/100ML;31MG/100ML;120MG/100ML;330MG/100ML;88MG/100M
L~N~019864~001~~Jun 10, 1993~Yes~RX~B BRAUN MEDICAL INC
TE; SODIUM CHLORIDE~INJECTABLE;INJECTION~ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CON
TAINER~B BRAUN~37MG/100ML;5GM/100ML;31MG/100ML;120MG/100ML;330MG/100ML;88MG/100M
L~N~018271~001~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
E; SODIUM GLUCONATE~INJECTABLE;INJECTION~ISOLYTE S IN DEXTROSE 5% IN PLASTIC CON
TAINER~B BRAUN~5GM/100ML;30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100
ML~N~019843~001~~Aug 9, 1993~No~RX~B BRAUN MEDICAL INC
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/100ML;500MG/100ML~N~018252~001~~Approved Prior to
Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
GLUCONATE~INJECTABLE;INJECTION~ISOLYTE S IN PLASTIC CONTAINER~B BRAUN~30MG/100ML
;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML~N~019711~001~~Sep 29, 1989~No~RX
~B BRAUN MEDICAL INC
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM A
CETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRA
TE~INJECTABLE;INJECTION~ISOLYTE S PH 7.4 IN PLASTIC CONTAINER~B BRAUN~30MG/100ML
;37MG/100ML;0.82MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML;12MG/100ML~N~019006
~001~~Apr 4, 1984~No~DISCN~B BRAUN MEDICAL INC
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM A
CETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRA
TE~INJECTABLE;INJECTION~ISOLYTE S PH 7.4 IN PLASTIC CONTAINER~B BRAUN~30MG/100ML
;37MG/100ML;0.82MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML;12MG/100ML~N~019696
~001~~Sep 29, 1989~Yes~RX~B BRAUN MEDICAL INC
E; SODIUM GLUCONATE~INJECTABLE;INJECTION~ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CON
TAINER~B BRAUN~5GM/100ML;30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100
ISONIAZID~INJECTABLE;INJECTION~ISONIAZID~SANDOZ~100MG/ML~A~040648~001~~Jul 5, 20
05~Yes~RX~SANDOZ CANADA INC
CALCIUM; MEGLUMINE; METRIZOIC ACID~INJECTABLE;INJECTION~ISOPAQUE 280~GE HEALTHCA
RE~0.35MG/ML;140.1MG/ML;461.8MG/ML~N~017506~001~~Approved Prior to Jan 1, 1982~N
o~DISCN~GE HEALTHCARE
CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIU
M~INJECTABLE;INJECTION~ISOPAQUE 440~GE HEALTHCARE~0.78MG/ML;75.9MG/ML;0.15MG/ML;
16.6MG/ML~N~016847~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
ISOPROTERENOL HYDROCHLORIDE~INJECTABLE;INJECTION~ISOPROTERENOL HYDROCHLORIDE~ABR
AXIS PHARM~0.2MG/ML~A~083431~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS
ISOPROTERENOL HYDROCHLORIDE~INJECTABLE;INJECTION~ISOPROTERENOL HYDROCHLORIDE~BAX
TER HLTHCARE~0.2MG/ML~A~083486~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTE
R HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
ISOPROTERENOL HYDROCHLORIDE~INJECTABLE;INJECTION~ISOPROTERENOL HYDROCHLORIDE~HOS
PIRA~0.02MG/ML~A~083283~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
ISOPROTERENOL HYDROCHLORIDE~INJECTABLE;INJECTION~ISOPROTERENOL HYDROCHLORIDE~HOS

PIRA~0.2MG/ML~A~083346~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
ISOPROTERENOL HYDROCHLORIDE~INJECTABLE;INJECTION~ISOPROTERENOL HYDROCHLORIDE~INT
L MEDICATION~0.2MG/ML~A~083724~001~~Approved Prior to Jan 1, 1982~No~DISCN~INTER
NATIONAL MEDICATION SYSTEM
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~ISOPTIN~FSC~2.5MG/ML~N~018485~001~~
Approved Prior to Jan 1, 1982~No~DISCN~FSC LABORATORIES INC
ISOSULFAN BLUE~INJECTABLE;INJECTION~ISOSULFAN BLUE~MYLAN INSTITUTIONAL~1%~A~0908
74~001~~Jul 20, 2010~Yes~RX~MYLAN INSTITUTIONAL LLC
GENTAMICIN SULFATE~INJECTABLE;INJECTION~ISOTONIC GENTAMICIN SULFATE IN PLASTIC C
ONTAINER~BAXTER HLTHCARE~EQ 0.8MG BASE/ML~A~062373~001~AP~Sep 7, 1982~No~RX~BAXT
ER HEALTHCARE CORP
ER HEALTHCARE CORP
ER HEALTHCARE CORP
ONTAINER~BAXTER HLTHCARE~EQ 2MG BASE/ML~A~062373~009~AP~Sep 7, 1982~No~RX~BAXTER
HEALTHCARE CORP
ER HEALTHCARE CORP
ONTAINER~BAXTER HLTHCARE~EQ 40MG BASE/100ML~A~062373~003~AP~Sep 7, 1982~No~RX~BA
ONTAINER~BAXTER HLTHCARE~EQ 100MG BASE/100ML~A~062373~005~AP~Sep 7, 1982~No~RX~B
ONTAINER~BAXTER HLTHCARE~EQ 120MG BASE/100ML~A~062373~006~AP~Sep 7, 1982~No~RX~B
IOPAMIDOL~INJECTABLE;INJECTION~ISOVUE-128~BRACCO~26%~N~018735~005~~Oct 21, 1986~
No~DISCN~BRACCO DIAGNOSTICS INC
IOPAMIDOL~INJECTABLE;INJECTION~ISOVUE-200~BRACCO~41%~N~018735~006~~Jul 7, 1987~Y
es~RX~BRACCO DIAGNOSTICS INC
No~DISCN~BRACCO DIAGNOSTICS INC
IOPAMIDOL~INJECTABLE;INJECTION~ISOVUE-250~BRACCO~51%~N~018735~007~~Jul 6, 1992~Y
es~RX~BRACCO DIAGNOSTICS INC
Yes~RX~BRACCO DIAGNOSTICS INC
IOPAMIDOL~INJECTABLE;INJECTION~ISOVUE-300~BRACCO~61%~N~018735~002~AP~Dec 31, 198
5~Yes~RX~BRACCO DIAGNOSTICS INC
IOPAMIDOL~INJECTABLE;INJECTION~ISOVUE-370~BRACCO~76%~N~018735~003~AP~Dec 31, 198
IOPAMIDOL~INJECTABLE;INJECTION~ISOVUE-M 200~BRACCO~41%~N~018735~001~~Dec 31, 198
IOPAMIDOL~INJECTABLE;INJECTION~ISOVUE-M 300~BRACCO~61%~N~018735~004~~Dec 31, 198

ISOPROTERENOL HYDROCHLORIDE~INJECTABLE;INJECTION~ISUPREL~HOSPIRA~0.2MG/ML~N~0105
15~001~~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
DIPYRIDAMOLE~INJECTABLE;INJECTION~IV PERSANTINE~BOEHRINGER INGELHEIM~5MG/ML~N~01
9817~001~~Dec 13, 1990~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
NITROFURANTOIN SODIUM~INJECTABLE;INJECTION~IVADANTIN~PROCTER AND GAMBLE~EQ 180MG
BASE/VIAL~N~012402~001~~Approved Prior to Jan 1, 1982~No~DISCN~PROCTER AND GAMB
LE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
ALBUMIN IODINATED I-125 SERUM~INJECTABLE;INJECTION~JEANATOPE~ISO TEX~100uCi/10ML
(10uCi/ML)~N~017836~003~~Jun 8, 2004~No~RX~ISO TEX DIAGNOSTICS INC
ALBUMIN IODINATED I-125 SERUM~INJECTABLE;INJECTION~JEANATOPE~ISO TEX~500uCi/0.5M
L~N~017836~001~~Approved Prior to Jan 1, 1982~No~RX~ISO TEX DIAGNOSTICS INC
ALBUMIN IODINATED I-125 SERUM~INJECTABLE;INJECTION~JEANATOPE~ISO TEX~1,000uCi/ML
~N~017836~002~~Approved Prior to Jan 1, 1982~Yes~RX~ISO TEX DIAGNOSTICS INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN~HIKMA MAPLE ~EQ 1GM BASE/3ML~A~
062324~003~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN~HIKMA MAPLE ~EQ 75MG BASE/2ML~A
~062324~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN~HIKMA MAPLE ~EQ 500MG BASE/2ML~
A~062324~002~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~ABRAXIS PHARM~EQ 1GM BA
SE/3ML~A~062504~003~~Apr 5, 1984~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~ABRAXIS PHARM~EQ 75MG B
ASE/2ML~A~062504~001~~Apr 5, 1984~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~ABRAXIS PHARM~EQ 500MG
BASE/2ML~A~062504~002~~Apr 5, 1984~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~FRESENIUS KABI USA~EQ 1
GM BASE/3ML~A~065111~002~~Dec 17, 2002~Yes~RX~FRESENIUS KABI USA LLC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~FRESENIUS KABI USA~EQ 5
00MG BASE/2ML~A~065111~001~~Dec 17, 2002~No~RX~FRESENIUS KABI USA LLC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~INTL MEDICATION~EQ 1GM
BASE/3ML~A~062466~002~~Sep 30, 1983~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LT
D
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~INTL MEDICATION~EQ 500M
G BASE/2ML~A~062466~001~~Sep 30, 1983~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS
LTD
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~LOCH~EQ 1GM BASE/3ML~A~
063025~001~~Jul 31, 1992~No~DISCN~LOCH PHARMACEUTICALS INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~LOCH~EQ 75MG BASE/2ML~A
~063021~001~~Jul 31, 1992~No~DISCN~LOCH PHARMACEUTICALS INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~LOCH~EQ 500MG BASE/2ML~
A~063022~001~~Jul 31, 1992~No~DISCN~LOCH PHARMACEUTICALS INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~PHARMAFAIR~EQ 1GM BASE/
3ML~A~062669~001~~May 7, 1987~No~DISCN~PHARMAFAIR INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~PHARMAFAIR~EQ 75MG BASE
/2ML~A~062668~001~~May 7, 1987~No~DISCN~PHARMAFAIR INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~PHARMAFAIR~EQ 500MG BAS
E/2ML~A~062672~001~~May 7, 1987~No~DISCN~PHARMAFAIR INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~SOLOPAK~EQ 1GM BASE/3ML
~A~062605~002~~Feb 26, 1986~No~DISCN~SOLOPAK LABORATORIES INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~SOLOPAK~EQ 75MG BASE/2M
L~A~062605~003~~Feb 26, 1986~No~DISCN~SOLOPAK LABORATORIES INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~SOLOPAK~EQ 500MG BASE/2
ML~A~062605~001~~Feb 26, 1986~No~DISCN~SOLOPAK LABORATORIES INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~WARNER CHILCOTT~EQ 1GM
BASE/3ML~A~063092~001~~Oct 11, 1989~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT
CO
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANAMYCIN SULFATE~WATSON LABS~EQ 1GM BASE
/3ML~A~062520~003~~May 9, 1985~No~DISCN~WATSON LABORATORIES INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANTREX~APOTHECON~EQ 1GM BASE/3ML~A~06165

UIBB
UIBB
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KANTREX~APOTHECON~EQ 75MG BASE/2ML~A~0616
QUIBB
QUIBB
SQUIBB
SQUIBB
MENADIOL SODIUM DIPHOSPHATE~INJECTABLE;INJECTION~KAPPADIONE~LILLY~10MG/ML~N~0057
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~KEFLIN~LILLY~EQ 1GM BASE/VIAL~N~050482~0
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~KEFLIN~LILLY~EQ 20GM BASE/VIAL~N~050482~
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~KEFLIN IN PLASTIC CONTAINER~LILLY~EQ 1GM
BASE/VIAL~A~062549~001~~Sep 10, 1985~No~DISCN~ELI LILLY AND CO
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~KEFLIN IN PLASTIC CONTAINER~LILLY~EQ 2GM
BASE/VIAL~A~062549~002~~Sep 10, 1985~No~DISCN~ELI LILLY AND CO
CEFUROXIME SODIUM~INJECTABLE;INJECTION~KEFUROX~ACS DOBFAR~EQ 1.5GM BASE/VIAL~A~0
62591~002~~Jan 10, 1986~No~DISCN~ACS DOBFAR SPA
CEFUROXIME SODIUM~INJECTABLE;INJECTION~KEFUROX~ACS DOBFAR~EQ 7.5GM BASE/VIAL~A~0
62591~003~~Dec 17, 1987~No~DISCN~ACS DOBFAR SPA
CEFUROXIME SODIUM~INJECTABLE;INJECTION~KEFUROX~LILLY~EQ 1.5GM BASE/VIAL~A~062592
~002~~Jan 10, 1986~No~DISCN~ELI LILLY AND CO
CEFUROXIME SODIUM~INJECTABLE;INJECTION~KEFUROX IN PLASTIC CONTAINER~LILLY~EQ 1.5
GM BASE/VIAL~A~062590~002~~Jan 10, 1986~No~DISCN~ELI LILLY AND CO
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~KEFZOL~ACS DOBFAR~EQ 1GM BASE/VIAL~A~06177
3~003~AP~Approved Prior to Jan 1, 1982~No~RX~ACS DOBFAR SPA
73~005~~Sep 8, 1987~No~DISCN~ACS DOBFAR SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~KEFZOL~ACS DOBFAR~EQ 250MG BASE/VIAL~A~061
773~001~~Approved Prior to Jan 1, 1982~No~DISCN~ACS DOBFAR SPA
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~KEFZOL~ACS DOBFAR~EQ 500MG BASE/VIAL~A~061
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~KEFZOL~LILLY~EQ 1GM BASE/VIAL~A~062557~002
~~Sep 10, 1985~No~DISCN~ELI LILLY AND CO
CEFAZOLIN SODIUM~INJECTABLE;INJECTION~KEFZOL~LILLY~EQ 500MG BASE/VIAL~A~062557~0
01~~Sep 10, 1985~No~DISCN~ELI LILLY AND CO
TRIAMCINOLONE ACETONIDE~INJECTABLE;INJECTION~KENALOG-10~APOTHECON~10MG/ML~N~0120
41~001~~Approved Prior to Jan 1, 1982~No~RX~APOTHECON INC DIV BRISTOL MYERS SQUI

BB
TRIAMCINOLONE ACETONIDE~INJECTABLE;INJECTION~KENALOG-40~APOTHECON~40MG/ML~N~0149
01~001~~Approved Prior to Jan 1, 1982~Yes~RX~APOTHECON INC DIV BRISTOL MYERS SQU
IBB
KETAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~KETALAR~PAR STERILE PRODUCTS~EQ 10MG
BASE/ML~N~016812~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUC
TS LLC
KETAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~KETALAR~PAR STERILE PRODUCTS~EQ 50MG
BASE/ML~N~016812~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUC
TS LLC
KETAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~KETALAR~PAR STERILE PRODUCTS~EQ 100M
G BASE/ML~N~016812~003~AP~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODU
CTS LLC
KETAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~KETAMINE HYDROCHLORIDE~EUROHLTH INTL
SARL~EQ 50MG BASE/ML~A~074524~001~AP~Mar 22, 1996~No~RX~EUROHEALTH INTERNATIONA
L SARL
KETAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~KETAMINE HYDROCHLORIDE~EUROHLTH INTL
SARL~EQ 100MG BASE/ML~A~074524~002~AP~Mar 22, 1996~No~RX~EUROHEALTH INTERNATION
AL SARL
KETAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~KETAMINE HYDROCHLORIDE~HOSPIRA~EQ 50
MG BASE/ML~A~074549~001~AP~Jun 27, 1996~No~RX~HOSPIRA INC
KETAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~KETAMINE HYDROCHLORIDE~HOSPIRA~EQ 10
0MG BASE/ML~A~074549~002~AP~Jun 27, 1996~No~RX~HOSPIRA INC
KETAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~KETAMINE HYDROCHLORIDE~MYLAN INSTITU
TIONAL~EQ 10MG BASE/ML~A~076092~001~AP~Sep 30, 2008~No~RX~MYLAN INSTITUTIONAL LL
C
TIONAL~EQ 50MG BASE/ML~A~076092~002~AP~Dec 28, 2001~No~RX~MYLAN INSTITUTIONAL LL
C
TIONAL~EQ 100MG BASE/ML~A~076092~003~AP~Oct 25, 2002~No~RX~MYLAN INSTITUTIONAL L
LC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~AGILA SPECLTS
~15MG/ML~A~078299~001~AP~Jul 16, 2007~No~RX~AGILA SPECIALTIES PRIVATE LTD
~15MG/ML~A~201155~001~AP~Aug 4, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD
~30MG/ML~A~078299~002~AP~Jul 16, 2007~No~RX~AGILA SPECIALTIES PRIVATE LTD
~30MG/ML~A~201155~002~AP~Aug 4, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~AMPHASTAR PHA
RM~15MG/ML~A~076209~001~~Jul 21, 2004~No~DISCN~AMPHASTAR PHARMACEUTICAL INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~AMPHASTAR PHA
RM~30MG/ML~A~076209~002~~Jul 21, 2004~No~DISCN~AMPHASTAR PHARMACEUTICAL INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~APOTEX INC~15
MG/ML~A~075631~002~~Jun 29, 2001~No~DISCN~APOTEX INC
MG/ML~A~075626~001~~Jul 24, 2001~No~DISCN~APOTEX INC
MG/ML~A~075631~001~~Jun 29, 2001~No~DISCN~APOTEX INC
MG/ML~A~077201~001~~Oct 14, 2005~No~DISCN~APOTEX INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~APOTHECON~15M
G/ML~A~075348~001~~Nov 28, 2000~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~APOTHECON~30M
G/ML~A~075348~002~~Nov 28, 2000~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~BEDFORD~15MG/
ML **Federal Register determination that product was not discontinued or withdra
wn for safety or efficacy reasons**~A~075222~001~~Apr 26, 1999~No~DISCN~BEDFORD
LABORATORIES DIV BEN VENUE LABORATORIES INC

ML~A~075230~002~~Oct 25, 1999~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORA
TORIES INC
ML~A~075230~001~~Oct 25, 1999~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORA
TORIES INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~FRESENIUS KAB
I USA~15MG/ML~A~075784~001~AP~Jan 11, 2002~No~RX~FRESENIUS KABI USA LLC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~FRESENIUS KAB
I USA~30MG/ML~A~075784~002~AP~Jan 11, 2002~No~RX~FRESENIUS KABI USA LLC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~GLAND PHARMA
LTD~15MG/ML~A~076722~001~~Jul 27, 2004~No~DISCN~GLAND PHARMA LTD
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~GLAND PHARMA
LTD~30MG/ML~A~076722~002~~Jul 27, 2004~No~DISCN~GLAND PHARMA LTD
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~HIKMA MAPLE ~
15MG/ML~A~075299~001~~Nov 3, 1999~No~DISCN~HIKMA MAPLE LTD
15MG/ML~A~075772~001~~Jul 21, 2004~No~DISCN~HIKMA MAPLE LTD
30MG/ML~A~075299~002~~Nov 3, 1999~No~DISCN~HIKMA MAPLE LTD
30MG/ML~A~075772~002~~Jul 21, 2004~No~DISCN~HIKMA MAPLE LTD
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~HOSPIRA~15MG/
ML~A~074801~001~~Jun 5, 1997~No~DISCN~HOSPIRA INC
ML~A~074802~001~AP~Jun 5, 1997~Yes~RX~HOSPIRA INC
ML~A~074993~001~AP~Jan 27, 1999~No~RX~HOSPIRA INC
ML~A~074801~002~~Jun 5, 1997~No~DISCN~HOSPIRA INC
ML~A~074802~002~AP~Jun 5, 1997~Yes~RX~HOSPIRA INC
ML~A~074993~002~AP~Jan 27, 1999~No~RX~HOSPIRA INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~LUITPOLD~15MG
/ML~A~078145~001~~Jan 14, 2008~No~DISCN~LUITPOLD PHARMACEUTICALS INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~LUITPOLD~30MG
/ML~A~078145~002~~Jan 14, 2008~No~DISCN~LUITPOLD PHARMACEUTICALS INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~SAGENT PHARMS
~15MG/ML~A~091065~001~AP~Nov 27, 2013~No~RX~SAGENT PHARMACEUTICALS INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~SAGENT PHARMS
~30MG/ML~A~091065~002~AP~Nov 27, 2013~No~RX~SAGENT PHARMACEUTICALS INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~SANDOZ~15MG/M
L~A~076271~001~~Oct 6, 2004~No~DISCN~SANDOZ CANADA INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~SANDOZ~30MG/M
L~A~076271~002~AP~Oct 6, 2004~No~RX~SANDOZ CANADA INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~SUN PHARMA GL
OBAL~15MG/ML~A~078737~001~~Oct 6, 2008~No~DISCN~SUN PHARMA GLOBAL INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~SUN PHARMA GL
OBAL~30MG/ML~A~078737~002~~Oct 6, 2008~No~DISCN~SUN PHARMA GLOBAL INC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~KETOROLAC TROMETHAMINE~WOCKHARDT~15M
G/ML~A~077942~001~AP~Mar 27, 2007~No~RX~WOCKHARDT LTD

G/ML~A~077942~002~AP~Mar 27, 2007~No~RX~WOCKHARDT LTD
G/ML~A~077943~001~~Mar 27, 2007~No~DISCN~WOCKHARDT LTD
SINCALIDE~INJECTABLE;INJECTION~KINEVAC~BRACCO~0.005MG/VIAL~N~017697~001~~Approve
d Prior to Jan 1, 1982~Yes~RX~BRACCO DIAGNOSTICS INC
UROKINASE~INJECTABLE;INJECTION~KINLYTIC~MICROBIX BIOSYSTEMS~5,000 IU/VIAL~N~0218
46~003~~Approved Prior to Jan 1, 1982~No~DISCN~MICROBIX BIOSYSTEMS INC
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KLEBCIL~KING PHARMS~EQ 1GM BASE/3ML~A~062
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KLEBCIL~KING PHARMS~EQ 75MG BASE/2ML~A~06
KANAMYCIN SULFATE~INJECTABLE;INJECTION~KLEBCIL~KING PHARMS~EQ 500MG BASE/2ML~A~0
PHYTONADIONE~INJECTABLE;INJECTION~KONAKION~ROCHE~1MG/0.5ML~N~011745~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
PHYTONADIONE~INJECTABLE;INJECTION~KONAKION~ROCHE~10MG/ML~N~011745~003~~Approved
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~KYTRIL~ROCHE~EQ 0.1MG BASE/ML (EQ
0.1MG BASE/ML) **Federal Register determination that product was not discontinu
ed or withdrawn for safety or efficacy reasons**~N~020239~003~~Sep 17, 2004~No~D
ISCN~HOFFMANN LA ROCHE INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~KYTRIL~ROCHE~EQ 1MG BASE/ML (EQ 1
MG BASE/ML) **Federal Register determination that product was not discontinued o
r withdrawn for safety or efficacy reasons**~N~020239~004~~Mar 11, 1994~No~DISCN
~HOFFMANN LA ROCHE INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~KYTRIL~ROCHE~EQ 3MG BASE/ML **Fed
afety or efficacy reasons**~N~020239~001~~Dec 29, 1993~No~DISCN~HOFFMANN LA ROCH
E INC
GRANISETRON HYDROCHLORIDE~INJECTABLE;INJECTION~KYTRIL~ROCHE~EQ 4MG BASE/4ML (EQ
1MG BASE/ML) **Federal Register determination that product was not discontinued
or withdrawn for safety or efficacy reasons**~N~020239~002~~Mar 11, 1994~No~DISC
N~HOFFMANN LA ROCHE INC
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~LABETALOL HYDROCHLORIDE~AKORN INC~5
MG/ML~A~075431~001~AP~Nov 29, 1999~No~RX~AKORN INC
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~LABETALOL HYDROCHLORIDE~AKORN INC~5
MG/ML~A~075524~001~AP~Nov 29, 1999~No~RX~AKORN INC
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~LABETALOL HYDROCHLORIDE~APOTEX INC~
5MG/ML~A~076051~001~~Jul 5, 2002~No~DISCN~APOTEX INC
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~LABETALOL HYDROCHLORIDE~APOTHECON~5
MG/ML~A~075355~001~~Nov 29, 1999~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~LABETALOL HYDROCHLORIDE~EUROHLTH IN
TL SARL~5MG/ML~A~075303~001~AP~May 28, 1999~No~RX~EUROHEALTH INTERNATIONAL SARL
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~LABETALOL HYDROCHLORIDE~GLAND PHARM
A LTD~5MG/ML~A~090699~001~AP~Apr 3, 2012~No~RX~GLAND PHARMA LTD
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~LABETALOL HYDROCHLORIDE~HOSPIRA~5MG
/ML~A~075239~001~AP~Nov 29, 1999~Yes~RX~HOSPIRA INC
/ML~A~075240~001~AP~Nov 29, 1999~Yes~RX~HOSPIRA INC
/ML~A~075242~001~~Sep 30, 1999~No~DISCN~HOSPIRA INC
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~LABETALOL HYDROCLORIDE~SAGENT STRID
ES~5MG/ML~A~079134~001~AP~Feb 3, 2010~No~RX~SAGENT STRIDES LLC
INJECTABLE;INJECTION~LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER~BAXT

ER HLTHCARE~20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML~N~016679~001
~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE~INJECTABLE
;INJECTION~LACTATED RINGER'S IN PLASTIC CONTAINER~ABBOTT~20MG/100ML;30MG/100ML;6
00MG/100ML;310MG/100ML~N~019485~001~~Oct 24, 1985~No~DISCN~ABBOTT LABORATORIES P
;INJECTION~LACTATED RINGER'S IN PLASTIC CONTAINER~B BRAUN~20MG/100ML;30MG/100ML;
600MG/100ML;310MG/100ML~N~018023~001~~Approved Prior to Jan 1, 1982~No~DISCN~B B
RAUN MEDICAL INC
;INJECTION~LACTATED RINGER'S IN PLASTIC CONTAINER~B BRAUN~20MG/100ML;30MG/100ML;
600MG/100ML;310MG/100ML~N~019632~001~AP~Feb 29, 1988~No~RX~B BRAUN MEDICAL INC
;INJECTION~LACTATED RINGER'S IN PLASTIC CONTAINER~BAXTER HLTHCARE~20MG/100ML;30M
G/100ML;600MG/100ML;310MG/100ML~N~016682~001~AP~Approved Prior to Jan 1, 1982~No
~RX~BAXTER HEALTHCARE CORP
;INJECTION~LACTATED RINGER'S IN PLASTIC CONTAINER~HOSPIRA~20MG/100ML;30MG/100ML;
600MG/100ML;310MG/100ML~N~017641~001~AP~Approved Prior to Jan 1, 1982~No~RX~HOSP
IRA INC
;INJECTION~LACTATED RINGER'S IN PLASTIC CONTAINER~MILES~20MG/100ML;30MG/100ML;60
0MG/100ML;310MG/100ML~N~018417~001~~Approved Prior to Jan 1, 1982~No~DISCN~MILES
LABORATORIES INC
DIGOXIN~INJECTABLE;INJECTION~LANOXIN~COVIS INJECTABLES~0.25MG/ML~N~009330~002~AP
~Approved Prior to Jan 1, 1982~Yes~RX~COVIS INJECTABLES SARL
DIGOXIN~INJECTABLE;INJECTION~LANOXIN PEDIATRIC~COVIS INJECTABLES~0.1MG/ML~N~0093
30~004~~Approved Prior to Jan 1, 1982~Yes~RX~COVIS INJECTABLES SARL
INSULIN GLARGINE RECOMBINANT~INJECTABLE;INJECTION~LANTUS~SANOFI AVENTIS US~100 U
NITS/ML~N~021081~001~~Apr 20, 2000~Yes~RX~SANOFI AVENTIS US LLC
INSULIN GLARGINE RECOMBINANT~INJECTABLE;INJECTION~LANTUS SOLOSTAR~SANOFI AVENTIS
US~300 UNITS/3ML (100 UNITS/ML)~N~021081~002~~Apr 27, 2007~Yes~RX~SANOFI AVENTI
S US LLC
PROPIOMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~LARGON~HIKMA MAPLE ~20MG/ML~N~01
2382~002~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
FUROSEMIDE~INJECTABLE;INJECTION~LASIX~SANOFI AVENTIS US~10MG/ML~N~016363~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
INSULIN ZINC SUSP PURIFIED BEEF/PORK~INJECTABLE;INJECTION~LENTARD~NOVO NORDISK I
NC~100 UNITS/ML~N~018384~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NORDIS
K INC
INSULIN ZINC SUSP PURIFIED PORK~INJECTABLE;INJECTION~LENTE~NOVO NORDISK INC~100
UNITS/ML~N~018383~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NORDISK INC
INSULIN ZINC SUSP PURIFIED BEEF~INJECTABLE;INJECTION~LENTE ILETIN II~LILLY~100 U
NITS/ML~N~018477~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
INSULIN ZINC SUSP PURIFIED PORK~INJECTABLE;INJECTION~LENTE ILETIN II (PORK)~LILL
Y~100 UNITS/ML~N~018347~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AN
D CO
INSULIN ZINC SUSP BEEF~INJECTABLE;INJECTION~LENTE INSULIN~NOVO NORDISK INC~40 UN
ITS/ML~N~017998~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NORDISK INC
INSULIN ZINC SUSP BEEF~INJECTABLE;INJECTION~LENTE INSULIN~NOVO NORDISK INC~100 U
NITS/ML~N~017998~003~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NORDISK INC
ANILERIDINE PHOSPHATE~INJECTABLE;INJECTION~LERITINE~MERCK~25MG/ML~N~010520~003~~
Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~ABIC~EQ 3MG BASE/ML~A
~089352~001~~Jun 1, 1988~No~DISCN~ABIC LTD
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~ABIC~EQ 50MG BASE/VIA
L~A~089353~001~~Jun 1, 1988~No~DISCN~ABIC LTD
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~ABRAXIS PHARM~EQ 50MG
BASE/VIAL~A~088939~001~~Dec 1, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS

LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~ELKINS SINN~EQ 50MG B
ASE/VIAL~A~070480~001~~Jan 2, 1987~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~ELKINS SINN~EQ 100MG
BASE/VIAL~A~081224~001~~Jun 3, 1994~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~EUROHLTH INTL SARL~EQ
50MG BASE/VIAL~A~089384~001~AP~Sep 14, 1987~Yes~RX~EUROHEALTH INTERNATIONAL SAR
L
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~EUROHLTH INTL SARL~EQ
100MG BASE/VIAL~A~089717~001~AP~Mar 28, 1988~Yes~RX~EUROHEALTH INTERNATIONAL SA
RL
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~HOSPIRA~EQ 3MG BASE/M
L~N~008107~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~HOSPIRA~EQ 50MG BASE/
VIAL~N~008107~002~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~HOSPIRA~EQ 100MG BASE
/VIAL~N~008107~004~~May 23, 1988~No~DISCN~HOSPIRA INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~HOSPIRA~EQ 350MG BASE
/VIAL~N~008107~005~~Apr 5, 1989~No~DISCN~HOSPIRA INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~PHARMACHEMIE~EQ 350MG
BASE/VIAL~A~040262~001~~Dec 15, 1999~No~DISCN~PHARMACHEMIE BV
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~PHARMACHEMIE USA~EQ 5
0MG BASE/VIAL~A~089628~001~~Apr 17, 1997~No~DISCN~PHARMACHEMIE USA INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~PHARMACHEMIE USA~EQ 1
00MG BASE/VIAL~A~089915~001~~Apr 17, 1997~No~DISCN~PHARMACHEMIE USA INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~TEVA PARENTERAL~EQ 50
MG BASE/VIAL~A~081278~001~~Sep 28, 1993~No~DISCN~TEVA PARENTERAL MEDICINES INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~TEVA PHARMS USA~EQ 10
0MG BASE/VIAL~A~081277~001~AP~Sep 28, 1993~No~RX~TEVA PHARMACEUTICALS USA
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM~TEVA PHARMS USA~EQ 35
0MG BASE/VIAL~A~040174~001~AP~Jun 12, 1997~No~RX~TEVA PHARMACEUTICALS USA
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM PRESERVATIVE FREE~EUR
OHLTH INTL SARL~EQ 10MG BASE/ML~A~040347~001~~Apr 25, 2000~Yes~RX~EUROHEALTH INT
ERNATIONAL SARL
OHLTH INTL SARL~EQ 200MG BASE/VIAL~A~040056~001~AP~May 23, 1995~Yes~RX~EUROHEALT
H INTERNATIONAL SARL
OHLTH INTL SARL~EQ 350MG BASE/VIAL~A~040335~001~AP~Apr 20, 2000~Yes~RX~EUROHEALT
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM PRESERVATIVE FREE~FRE
SENIUS KABI USA~EQ 200MG BASE/VIAL~A~040258~001~AP~Feb 26, 1999~No~RX~FRESENIUS
KABI USA LLC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM PRESERVATIVE FREE~FRE
SENIUS KABI USA~EQ 500MG BASE/VIAL~A~040286~001~~Feb 26, 1999~Yes~RX~FRESENIUS K
ABI USA LLC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM PRESERVATIVE FREE~HOS
PIRA~EQ 10MG BASE/ML **Federal Register determination that product was not disco
ntinued or withdrawn for safety or efficacy reasons**~A~040147~001~~Jun 25, 1997
~No~DISCN~HOSPIRA INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM PRESERVATIVE FREE~LUI
TPOLD~EQ 50MG BASE/VIAL~A~040338~001~~Jan 31, 2001~No~DISCN~LUITPOLD PHARMACEUTI
CALS INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM PRESERVATIVE FREE~SAG
ENT PHARMS~EQ 50MG BASE/VIAL~A~200753~001~AP~Sep 6, 2012~No~RX~SAGENT PHARMACEUT
ICALS INC
ENT PHARMS~EQ 100MG BASE/VIAL~A~200753~002~AP~Sep 6, 2012~No~RX~SAGENT PHARMACEU
TICALS INC

TICALS INC
TICALS INC
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~LEUCOVORIN CALCIUM PRESERVATIVE FREE~TEV
A PARENTERAL~EQ 10MG BASE/ML~A~040332~001~~Jun 28, 1999~No~DISCN~TEVA PARENTERAL
MEDICINES INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LEUPROLIDE ACETATE~GENZYME~1MG/0.2ML~A~0
75721~001~~Nov 29, 2001~No~DISCN~GENZYME CORPORATION
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LEUPROLIDE ACETATE~SANDOZ~1MG/0.2ML~A~07
4728~001~AP~Aug 4, 1998~Yes~RX~SANDOZ INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LEUPROLIDE ACETATE~SUN PHARMA GLOBAL~1MG
/0.2ML~A~078885~001~AP~Mar 9, 2009~No~RX~SUN PHARMA GLOBAL FZE
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LEUPROLIDE ACETATE~TEVA PHARMS USA~1MG/0
.2ML~A~075471~001~AP~Oct 25, 2000~No~RX~TEVA PHARMACEUTICALS USA
CLADRIBINE~INJECTABLE;INJECTION~LEUSTATIN~JANSSEN PHARMS~1MG/ML **Federal Regist
ficacy reasons**~N~020229~001~~Feb 26, 1993~No~DISCN~JANSSEN PHARMACEUTICALS INC
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVAQUIN~JANSSEN PHARMS~EQ 500MG/20ML (EQ 25MG
/ML)~N~020635~001~AP~Dec 20, 1996~Yes~RX~JANSSEN PHARMACEUTICALS INC
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVAQUIN~JANSSEN PHARMS~EQ 750MG/30ML (EQ 25MG
/ML)~N~020635~004~AP~Dec 20, 1996~Yes~RX~JANSSEN PHARMACEUTICALS INC
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER~J
ANSSEN PHARMS~EQ 250MG/50ML (EQ 5MG/ML)~N~020635~002~AP~Dec 20, 1996~Yes~RX~JANS
ANSSEN PHARMS~EQ 500MG/100ML (EQ 5MG/ML)~N~020635~003~AP~Dec 20, 1996~Yes~RX~JAN
SSEN PHARMACEUTICALS INC
ANSSEN PHARMS~EQ 750MG/150ML (EQ 5MG/ML)~N~020635~005~AP~Dec 20, 1996~Yes~RX~JAN
SSEN PHARMACEUTICALS INC
LEVORPHANOL TARTRATE~INJECTABLE;INJECTION~LEVO-DROMORAN~VALEANT PHARM INTL~2MG/M
L~N~008719~001~~Dec 19, 1991~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
LEVOCARNITINE~INJECTABLE;INJECTION~LEVOCARNITINE~EUROHLTH INTL SARL~200MG/ML~A~0
75567~001~AP~Mar 29, 2001~No~RX~EUROHEALTH INTERNATIONAL SARL
LEVOCARNITINE~INJECTABLE;INJECTION~LEVOCARNITINE~LUITPOLD~200MG/ML~A~075861~001~
AP~Jun 22, 2001~No~RX~LUITPOLD PHARMACEUTICALS INC
LEVOCARNITINE~INJECTABLE;INJECTION~LEVOCARNITINE~TEVA PHARMS USA~200MG/ML~A~0758
81~001~AP~Mar 29, 2001~No~RX~TEVA PHARMACEUTICALS USA
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~AKORN~EQ 500MG/20ML (EQ 25MG/ML)~
A~091644~001~~Jun 20, 2011~No~DISCN~AKORN INC
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~AKORN~EQ 750MG/30ML (EQ 25MG/ML)~
A~091644~002~~Jun 20, 2011~No~DISCN~AKORN INC
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~AUROBINDO PHARMA LTD~EQ 500MG/20M
L (EQ 25MG/ML)~A~202328~001~AP~Jan 24, 2013~No~RX~AUROBINDO PHARMA LTD
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~AUROBINDO PHARMA LTD~EQ 750MG/30M
L (EQ 25MG/ML)~A~202328~002~AP~Jan 24, 2013~No~RX~AUROBINDO PHARMA LTD
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~CLARIS LIFESCIENCES~EQ 500MG/20ML
(EQ 25MG/ML)~A~091436~001~AP~Jun 5, 2013~No~RX~CLARIS LIFESCIENCES LTD
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~EMCURE PHARMS LTD~EQ 500MG/20ML (
EQ 25MG/ML)~A~202590~001~AP~Jan 24, 2013~No~RX~EMCURE PHARMACEUTICALS LTD
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~EMCURE PHARMS LTD~EQ 750MG/30ML (
EQ 25MG/ML)~A~202590~002~AP~Jan 24, 2013~No~RX~EMCURE PHARMACEUTICALS LTD
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~SAGENT PHARMS~EQ 500MG/20ML (EQ 2
5MG/ML)~A~200560~001~AP~Jun 20, 2011~No~RX~SAGENT PHARMACEUTICALS INC
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN~SAGENT PHARMS~EQ 750MG/30ML (EQ 2
LEVOFLOXACIN~INJECTABLE;INJECTION~LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAIN
ER~ACS DOBFAR INFO SA~EQ 250MG/50ML (EQ 5MG/ML)~A~090343~001~AP~Jul 7, 2011~No~R
X~ACS DOBFAR INFO SA

ER~ACS DOBFAR INFO SA~EQ 500MG/100ML (EQ 5MG/ML)~A~090343~002~AP~Jul 7, 2011~No~
RX~ACS DOBFAR INFO SA
ER~ACS DOBFAR INFO SA~EQ 750MG/150ML (EQ 5MG/ML)~A~090343~003~AP~Jul 7, 2011~No~
RX~ACS DOBFAR INFO SA
ER~CLARIS LIFESCIENCES~EQ 250MG/50ML (EQ 5MG/ML)~A~091397~001~AP~Aug 8, 2013~No~
RX~CLARIS LIFESCIENCES LTD
ER~CLARIS LIFESCIENCES~EQ 500MG/100ML (EQ 5MG/ML)~A~091397~002~AP~Aug 8, 2013~No
~RX~CLARIS LIFESCIENCES LTD
ER~CLARIS LIFESCIENCES~EQ 750MG/150ML (EQ 5MG/ML)~A~091397~003~AP~Aug 8, 2013~No
~RX~CLARIS LIFESCIENCES LTD
ER~FRESENIUS KABI USA~EQ 250MG/50ML (EQ 5MG/ML)~A~200674~001~AP~Jun 19, 2013~No~
RX~FRESENIUS KABI USA LLC
ER~FRESENIUS KABI USA~EQ 500MG/100ML (EQ 5MG/ML)~A~200674~002~AP~Jun 19, 2013~No
~RX~FRESENIUS KABI USA LLC
ER~FRESENIUS KABI USA~EQ 750MG/150ML (EQ 5MG/ML)~A~200674~003~AP~Jun 19, 2013~No
ER~HIKMA FARMACEUTICA~EQ 250MG/50ML (EQ 5MG/ML)~A~091375~001~AP~Sep 16, 2011~No~
RX~HIKMA FARMACEUTICA (PORTUGAL) SA
ER~HIKMA FARMACEUTICA~EQ 500MG/100ML (EQ5MG/ML)~A~091375~002~AP~Sep 16, 2011~No~
RX~HIKMA FARMACEUTICA (PORTUGAL) SA
ER~HIKMA FARMACEUTICA~EQ 750MG/150ML (EQ 5MG/ML)~A~091375~003~AP~Sep 16, 2011~No
~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
NOREPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~LEVOPHED~HOSPIRA~EQ 1MG BASE/ML~N
~007513~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
LEVOMEPROMAZINE~INJECTABLE;INJECTION~LEVOPROME~IMMUNEX~20MG/ML~N~015865~001~~App
roved Prior to Jan 1, 1982~No~DISCN~IMMUNEX CORP
CHLORDIAZEPOXIDE HYDROCHLORIDE~INJECTABLE;INJECTION~LIBRIUM~VALEANT PHARMS LLC~1
00MG/AMP~N~012301~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUT
ICALS NORTH AMERICA LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~ABBOTT~10%~
A~087980~001~~Feb 2, 1983~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS D
IV
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~ABBOTT~20%~
A~089362~001~~May 25, 1988~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~ABRAXIS PHA
RM~1%~A~080420~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICA
L PRODUCTS
L PRODUCTS
RM~1.5%~A~080420~005~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTI
CAL PRODUCTS
L PRODUCTS
L PRODUCTS
L PRODUCTS
RM~2%~N~017508~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICA
L PRODUCTS
RM~4%~N~017508~002~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICA
L PRODUCTS
RM~20%~N~017508~004~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTIC
AL PRODUCTS
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~AGILA SPECL
TS~0.5%~A~091056~001~AP~Dec 8, 2010~No~RX~AGILA SPECIALTIES PRIVATE LTD
TS~0.5%~A~091058~001~AP~Sep 30, 2010~No~RX~AGILA SPECIALTIES PRIVATE LTD
TS~1%~A~091056~002~AP~Dec 8, 2010~No~RX~AGILA SPECIALTIES PRIVATE LTD
TS~1%~A~091058~002~AP~Sep 30, 2010~No~RX~AGILA SPECIALTIES PRIVATE LTD
TS~2%~A~202242~001~AP~Apr 11, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~AKORN~1%~A~
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~AKORN~2%~A~
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~BEL MAR~1%~
A~080710~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~BEL MAR~2%~
A~080760~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~DELL LABS~1
%~A~083387~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~DELL LABS~2
%~A~083388~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~ELKINS SINN
~0.5%~A~085131~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH RO
BINS CO INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~ELKINS SINN
~4%~A~084626~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBI
NS CO INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~GD SEARLE L
LC~1%~A~083135~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~GD SEARLE L
LC~2%~A~083135~002~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~GRAHAM CHEM
~2%~A~080504~001~~Approved Prior to Jan 1, 1982~No~DISCN~GRAHAM CHEMICAL CO
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~HIKMA MAPLE
~1%~A~080407~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~HIKMA MAPLE
~2%~A~080407~002~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~HOSPIRA~0.5
%~A~088328~001~AP~May 17, 1984~No~RX~HOSPIRA INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~HOSPIRA~1%~
A~040013~001~~Jun 23, 1995~No~DISCN~HOSPIRA WORLDWIDE, INC
A~083158~001~AP~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
A~088329~001~AP~May 17, 1984~No~RX~HOSPIRA INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~HOSPIRA~1.5
%~A~088330~001~~May 17, 1984~No~DISCN~HOSPIRA INC

A~040078~001~AP~Jun 23, 1995~No~RX~HOSPIRA INC
A~083158~002~AP~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
A~088294~001~AP~May 17, 1984~No~RX~HOSPIRA INC
A~088331~001~~May 17, 1984~No~DISCN~HOSPIRA INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~HOSPIRA~20%
~A~083158~003~AP~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~INTL MEDICA
TION~1%~A~083173~001~AP~Approved Prior to Jan 1, 1982~No~RX~INTERNATIONAL MEDICA
TION SYSTEM
TION~1%~N~017701~002~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL MEDIC
ATION SYSTEMS LTD
TION~1GM/VIAL~N~018543~001~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL
MEDICATION SYSTEMS LTD
TION~2%~A~083173~002~AP~Approved Prior to Jan 1, 1982~No~RX~INTERNATIONAL MEDICA
TION SYSTEM
TION~2%~N~017701~001~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL MEDIC
ATION SYSTEMS LTD
TION~2GM/VIAL~N~018543~002~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~LUITPOLD~1%
~A~080850~001~AP~Approved Prior to Jan 1, 1982~No~RX~LUITPOLD PHARMACEUTICALS IN
C
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~LUITPOLD~2%
~A~083198~001~~Approved Prior to Jan 1, 1982~No~DISCN~LUITPOLD PHARMACEUTICALS I
NC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~LYPHOMED~1%
~A~080390~001~~Approved Prior to Jan 1, 1982~No~DISCN~LYPHOMED DIV FUJISAWA USA
INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~LYPHOMED~2%
~A~080390~002~~Approved Prior to Jan 1, 1982~No~DISCN~LYPHOMED DIV FUJISAWA USA
INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~MILES~1%~A~
080414~001~~Approved Prior to Jan 1, 1982~No~DISCN~MILES LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~MILES~2%~A~
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~WATSON LABS
~1%~A~080377~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~WYETH AYERS
T~1%~A~083083~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATOR
IES
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE~WYETH AYERS
T~2%~A~083083~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATOR
IES
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE 0.1% AND DE
XTROSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~100MG/100ML~N~018461~001~~Approve

d Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP
XTROSE 5% IN PLASTIC CONTAINER~B BRAUN~200MG/100ML~N~018967~001~~Mar 30, 1984~No
XTROSE 5% IN PLASTIC CONTAINER~B BRAUN~200MG/100ML~N~019830~002~AP~Apr 8, 1992~N
o~RX~B BRAUN MEDICAL INC
XTROSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~200MG/100ML~N~018461~002~AP~Appro
ved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE 0.2% IN DEX
TROSE 5%~HOSPIRA~200MG/100ML~A~083158~005~~Approved Prior to Jan 1, 1982~No~DISC
N~HOSPIRA INC
TROSE 5% IN PLASTIC CONTAINER~ABBOTT~200MG/100ML~N~018954~001~~Jul 9, 1985~No~DI
SCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
TROSE 5% IN PLASTIC CONTAINER~HOSPIRA~200MG/100ML~N~018388~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~HOSPIRA INC
XTROSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~400MG/100ML~N~018461~003~AP~Appro
ved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
TROSE 5%~HOSPIRA~400MG/100ML~A~083158~006~~Approved Prior to Jan 1, 1982~No~DISC
N~HOSPIRA INC
TROSE 5% IN PLASTIC CONTAINER~HOSPIRA~400MG/100ML~N~018388~002~AP~Approved Prior
to Jan 1, 1982~No~RX~HOSPIRA INC
XTROSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~800MG/100ML~N~018461~004~AP~Feb 2
TROSE 5% IN PLASTIC CONTAINER~HOSPIRA~800MG/100ML~N~018388~003~AP~Nov 5, 1982~No
~RX~HOSPIRA INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORID
E AND EPINEPHRINE~EASTMAN KODAK~0.01MG/ML;2%~A~040057~002~AP~Feb 26, 1993~No~RX~
EASTMAN KODAK CO
E AND EPINEPHRINE~EASTMAN KODAK~0.02MG/ML;2%~A~040057~001~AP~Feb 26, 1993~No~RX~
EASTMAN KODAK CO
E AND EPINEPHRINE~GRAHAM CHEM~0.01MG/ML;2%~A~080504~004~~Oct 19, 1983~No~DISCN~G
RAHAM CHEMICAL CO
E AND EPINEPHRINE~GRAHAM CHEM~0.02MG/ML;2%~A~080504~005~~Oct 19, 1983~No~DISCN~G
RAHAM CHEMICAL CO
E AND EPINEPHRINE~HIKMA MAPLE ~0.01MG/ML;1%~A~080406~001~~Approved Prior to Jan

E AND EPINEPHRINE~HIKMA MAPLE ~0.01MG/ML;2%~A~080406~002~~Approved Prior to Jan
E AND EPINEPHRINE~HOSPIRA~0.005MG/ML;0.5%~A~089635~001~AP~Jun 21, 1988~No~RX~HOS
PIRA INC
E AND EPINEPHRINE~HOSPIRA~0.005MG/ML;1%~A~089649~001~~Jun 21, 1988~No~DISCN~HOSP
IRA WORLDWIDE, INC
E AND EPINEPHRINE~HOSPIRA~0.005MG/ML;1.5%~A~088571~001~AP~Sep 13, 1985~No~RX~HOS
PIRA INC
E AND EPINEPHRINE~HOSPIRA~0.005MG/ML;1.5%~A~089645~001~AP~Jun 21, 1988~No~RX~HOS
PIRA INC
E AND EPINEPHRINE~HOSPIRA~0.005MG/ML;1.5%~A~089650~001~~Jun 21, 1988~No~DISCN~HO
SPIRA INC
E AND EPINEPHRINE~HOSPIRA~0.005MG/ML;2%~A~089651~001~AP~Jun 21, 1988~No~RX~HOSPI
RA INC
E AND EPINEPHRINE~HOSPIRA~0.01MG/ML;1%~A~089644~001~AP~Jun 21, 1988~No~RX~HOSPIR
A INC
E AND EPINEPHRINE~HOSPIRA~0.01MG/ML;2%~A~078772~001~AP~May 12, 2008~No~RX~HOSPIR
A INC
E AND EPINEPHRINE~HOSPIRA~0.01MG/ML;2%~A~089646~001~AP~Jun 21, 1988~No~RX~HOSPIR
A INC
E AND EPINEPHRINE~HOSPIRA~0.02MG/ML;2%~A~078772~002~AP~May 12, 2008~No~RX~HOSPIR
A INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE IN PLASTIC
CONTAINER~FRESENIUS KABI USA~1%~A~088586~001~AP~Jul 24, 1985~No~RX~FRESENIUS KAB
I USA LLC
CONTAINER~HOSPIRA~0.5%~A~088325~001~AP~Jul 31, 1984~No~RX~HOSPIRA INC
CONTAINER~HOSPIRA~1%~A~088299~001~AP~Jul 31, 1984~No~RX~HOSPIRA INC
CONTAINER~HOSPIRA~1.5%~A~088326~001~~Jul 31, 1984~No~DISCN~HOSPIRA INC
CONTAINER~HOSPIRA~2%~A~088327~001~AP~Jul 31, 1984~No~RX~HOSPIRA INC
CONTAINER~HOSPIRA~10%~A~088367~001~~Jul 31, 1984~No~DISCN~HOSPIRA INC
CONTAINER~HOSPIRA~20%~A~088368~001~~Jul 31, 1984~No~DISCN~HOSPIRA INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCAINE HYDROCHLORIDE PRESERVATIV
E FREE~AGILA SPECLTS~2%~A~090665~001~AP~Sep 27, 2010~No~RX~AGILA SPECIALTIES PRI
VATE LTD
E FREE~AUROBINDO PHARMA LTD~1%~A~203040~001~AP~Mar 14, 2013~No~RX~AUROBINDO PHAR
MA LTD
MA LTD

MA LTD
MA LTD
E FREE~EUROHLTH INTL SARL~1%~A~084625~001~~Approved Prior to Jan 1, 1982~No~DISC
N~EUROHEALTH INTERNATIONAL SARL
E FREE~EUROHLTH INTL SARL~2%~A~084625~002~~Approved Prior to Jan 1, 1982~No~DISC
N~EUROHEALTH INTERNATIONAL SARL
E FREE~FRESENIUS KABI USA~1%~A~080404~002~AP~Approved Prior to Jan 1, 1982~No~RX
~FRESENIUS KABI USA LLC
E FREE~FRESENIUS KABI USA~2%~A~080404~003~AP~Approved Prior to Jan 1, 1982~No~RX
E FREE~FRESENIUS KABI USA~2%~N~017584~001~AP~Approved Prior to Jan 1, 1982~No~RX
E FREE~FRESENIUS KABI USA~4%~N~017584~002~AP~Approved Prior to Jan 1, 1982~No~RX
E FREE~HOSPIRA~1%~A~080408~001~AP~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA IN
C
E FREE~HOSPIRA~1.5%~A~080408~002~AP~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA
INC
E FREE~HOSPIRA~4%~A~088295~001~AP~May 17, 1984~No~RX~HOSPIRA INC
E FREE~INTL MEDICATION~4%~N~017702~002~~Approved Prior to Jan 1, 1982~No~DISCN~I
NTERNATIONAL MEDICATION SYSTEM
E FREE~INTL MEDICATION~20%~N~017702~001~AP~Approved Prior to Jan 1, 1982~No~RX~I
NTERNATIONAL MEDICATION SYSTEM
E FREE IN PLASTIC CONTAINER~HOSPIRA~1%~A~040302~001~AP~Sep 28, 1998~No~RX~HOSPIR
A INC
E FREE IN PLASTIC CONTAINER~HOSPIRA~2%~A~040302~002~AP~Sep 28, 1998~No~RX~HOSPIR
A INC
E W/ EPINEPHRINE~ABBOTT~0.01MG/ML;1%~A~083154~001~~Approved Prior to Jan 1, 1982
~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
E W/ EPINEPHRINE~BEL MAR~0.01MG/ML;1%~A~080820~001~~Approved Prior to Jan 1, 198
2~No~DISCN~BEL MAR LABORATORIES INC
E W/ EPINEPHRINE~BEL MAR~0.01MG/ML;2%~A~080757~001~~Approved Prior to Jan 1, 198
2~No~DISCN~BEL MAR LABORATORIES INC
E W/ EPINEPHRINE~DELL LABS~0.01MG/ML;1%~A~083389~001~~Approved Prior to Jan 1, 1
982~No~DISCN~DELL LABORATORIES INC
E W/ EPINEPHRINE~DELL LABS~0.01MG/ML;2%~A~083390~001~~Approved Prior to Jan 1, 1
982~No~DISCN~DELL LABORATORIES INC
E W/ EPINEPHRINE~INTL MEDICATION~0.01MG/ML;1%~A~086402~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~INTERNATIONAL MEDICATION SYSTEM

E W/ EPINEPHRINE~WATSON LABS~0.01MG/ML;1%~A~080377~003~~Approved Prior to Jan 1,
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCATON~PHARMATON~0.
01MG/ML;2%~A~084729~001~~Aug 17, 1983~No~DISCN~PHARMATON LTD
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCATON~PHARMATON~0.
02MG/ML;2%~A~084728~001~~Aug 17, 1983~No~DISCN~PHARMATON LTD
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOCATON~PHARMATON~2%~A~084727~001
~~Aug 17, 1983~No~DISCN~PHARMATON LTD
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIDOPEN~MERIDIAN MEDCL TECHN~10%~N~
017549~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERIDIAN MEDICAL TECHNOLOGIES
INC
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIGNOSPAN F
ORTE~DEPROCO~EQ 0.02MG BASE/ML;2%~A~088389~001~~Jan 22, 1985~Yes~RX~DEPROCO INC
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~LIGNOSPAN S
TANDARD~DEPROCO~EQ 0.01MG BASE/ML;2%~A~088390~001~~Jan 22, 1985~Yes~RX~DEPROCO I
NC
LINCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~LINCOCIN~PHARMACIA AND UPJOHN~EQ 3
00MG BASE/ML~N~050317~001~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UP
JOHN CO
LINCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~LINCOMYCIN HYDROCHLORIDE~WATSON LA
BS~EQ 300MG BASE/ML~A~063180~001~~Apr 16, 1991~No~DISCN~WATSON LABORATORIES INC
LINEZOLID~INJECTABLE;INJECTION~LINEZOLID~TEVA PHARMS~200MG/100ML~A~200222~001~AP
~Jun 27, 2012~No~RX~TEVA PHARMACEUTICALS USA
LIOTHYRONINE SODIUM~INJECTABLE;INJECTION~LIOTHYRONINE SODIUM~X GEN PHARMS~EQ 0.0
1MG BASE/ML~A~076923~001~AP~Aug 17, 2005~No~RX~X GEN PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~LIPO-HEPIN~3M~1,000 UNITS/0.5ML~N~017027~001
~~Approved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~LIPO-HEPIN~3M~1,000 UNITS/ML~N~017027~006~~A
pproved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~LIPO-HEPIN~3M~5,000 UNITS/ML~N~017027~008~~A
pproved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
3~~Approved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
HEPARIN SODIUM~INJECTABLE;INJECTION~LIPO-HEPIN~3M~10,000 UNITS/ML~N~017027~009~~
Approved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
SAFFLOWER OIL~INJECTABLE;INJECTION~LIPOSYN 10%~ABBOTT~10% (10GM/100ML)~N~018203~
001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL P
RODUCTS DIV
SAFFLOWER OIL~INJECTABLE;INJECTION~LIPOSYN 20%~ABBOTT~20% (20GM/100ML)~N~018614~
RODUCTS DIV
SAFFLOWER OIL; SOYBEAN OIL~INJECTABLE;INJECTION~LIPOSYN II 10%~HOSPIRA~5%;5% (5G
M/100ML)~N~018997~001~~Aug 27, 1984~No~DISCN~HOSPIRA INC
SAFFLOWER OIL; SOYBEAN OIL~INJECTABLE;INJECTION~LIPOSYN II 20%~HOSPIRA~10%;10% (
10GM/100ML)~N~018991~001~~Aug 27, 1984~No~DISCN~HOSPIRA INC
SOYBEAN OIL~INJECTABLE;INJECTION~LIPOSYN III 10%~HOSPIRA~10%~N~018969~001~~Sep 2
SOYBEAN OIL~INJECTABLE;INJECTION~LIPOSYN III 20%~HOSPIRA~20%~N~018970~001~~Sep 2
SOYBEAN OIL~INJECTABLE;INJECTION~LIPOSYN III 30%~HOSPIRA~30%~N~020181~001~~Jan 1
HEPARIN SODIUM~INJECTABLE;INJECTION~LIQUAEMIN LOCK FLUSH~ORGANON USA INC~100 UNI
TS/ML~N~000552~007~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~LIQUAEMIN SODIUM~ORGANON USA INC~1,000 UNITS
/ML~N~000552~004~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~LIQUAEMIN SODIUM~ORGANON USA INC~5,000 UNITS
/ML~N~000552~003~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~LIQUAEMIN SODIUM~ORGANON USA INC~10,000 UNIT
S/ML~N~000552~005~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
HEPARIN SODIUM~INJECTABLE;INJECTION~LIQUAEMIN SODIUM PRESERVATIVE FREE~ORGANON U
SA INC~1,000 UNITS/ML~N~000552~011~~Apr 11, 1986~No~DISCN~ORGANON USA INC
METOPROLOL TARTRATE~INJECTABLE;INJECTION~LOPRESSOR~NOVARTIS~1MG/ML~N~018704~001~
AP~Mar 30, 1984~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~AKORN~2MG/ML~A~074974~001~~Jul 23, 1998
~No~DISCN~AKORN INC
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~AKORN~2MG/ML~A~075025~001~AP~Jul 23, 19
98~No~RX~AKORN INC
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~BEDFORD~2MG/ML~A~077076~001~~Jul 13, 20
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~BEDFORD~4MG/ML~A~077076~002~~Jul 13, 20
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~DAVA PHARMS INC~2MG/ML~A~074793~001~~Ma
r 16, 2000~No~DISCN~DAVA PHARMACEUTICALS INC
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~DAVA PHARMS INC~4MG/ML~A~074793~002~~Ma
r 16, 2000~No~DISCN~DAVA PHARMACEUTICALS INC
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HIKMA MAPLE ~2MG/ML~A~074496~001~~Sep 2
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HIKMA MAPLE ~4MG/ML~A~074496~002~~Sep 2
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HOSPIRA~2MG/ML~A~074243~001~AP~Apr 12,
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HOSPIRA~2MG/ML~A~074280~001~~May 27, 19
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HOSPIRA~2MG/ML~A~074282~001~AP~May 27,
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HOSPIRA~2MG/ML~A~074300~001~~Apr 12, 19
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HOSPIRA~4MG/ML~A~074243~002~AP~Apr 12,
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HOSPIRA~4MG/ML~A~074280~002~~May 27, 19
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HOSPIRA~4MG/ML~A~074282~002~AP~May 27,
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~HOSPIRA~4MG/ML~A~074300~003~~Mar 19, 19
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~INTL MEDICATION SYS~2MG/ML~A~076150~001
~AP~Nov 15, 2004~No~RX~INTERNATIONAL MEDICATION SYSTEMS LTD
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~WATSON LABS~2MG/ML~A~074276~001~~Apr 15
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~WATSON LABS~4MG/ML~A~074276~002~~Apr 15
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~WATSON LABS INC~1MG/0.5ML~A~074551~003~
~Sep 12, 1996~No~DISCN~WATSON LABORATORIES INC
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM~WATSON LABS INC~2MG/ML~A~074535~001~~Se
p 12, 1996~No~DISCN~WATSON LABORATORIES INC
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM PRESERVATIVE FREE~BEDFORD LABS~2MG/ML~A
~077074~001~AP~Jul 13, 2005~No~RX~BEDFORD LABORATORIES
LORAZEPAM~INJECTABLE;INJECTION~LORAZEPAM PRESERVATIVE FREE~BEDFORD LABS~4MG/ML~A
~077074~002~AP~Jul 13, 2005~No~RX~BEDFORD LABORATORIES
LEVALLORPHAN TARTRATE~INJECTABLE;INJECTION~LORFAN~ROCHE~1MG/ML~N~010423~001~~App
roved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
LOXAPINE HYDROCHLORIDE~INJECTABLE;INJECTION~LOXITANE IM~WATSON LABS~EQ 50MG BASE
/ML~N~018039~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT~INJECTABLE;INJECTION~LUNGAGGREGATE REAG
ENT~GE HEALTHCARE~N/A~N~017838~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HE
ALTHCARE
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LUPRON~ABBVIE ENDOCRINE INC~1MG/0.2ML~N~
019010~001~~Apr 9, 1985~No~DISCN~ABBVIE ENDOCRINE INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LUPRON DEPOT~ABBVIE ENDOCRINE INC~3.75MG
/VIAL **Federal Register determination that product was not discontinued or with
drawn for safety or efficacy reasons**~N~020011~001~~Oct 22, 1990~No~DISCN~ABBVI
E ENDOCRINE INC
~N~020011~002~~Oct 26, 1995~Yes~RX~ABBVIE ENDOCRINE INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LUPRON DEPOT~ABBVIE ENDOCRINE INC~7.5MG/
VIAL~N~019732~001~~Jan 26, 1989~Yes~RX~ABBVIE ENDOCRINE INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LUPRON DEPOT~ABBVIE ENDOCRINE INC~11.25M
G/VIAL~N~020708~001~~Mar 7, 1997~Yes~RX~ABBVIE ENDOCRINE INC
/VIAL~N~020517~001~~Dec 22, 1995~Yes~RX~ABBVIE ENDOCRINE INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LUPRON DEPOT~ABBVIE ENDOCRINE INC~30MG/V
IAL~N~020517~002~~May 30, 1997~Yes~RX~ABBVIE ENDOCRINE INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LUPRON DEPOT~ABBVIE ENDOCRINE INC~45MG/V
IAL~N~020517~003~~Jun 17, 2011~No~RX~ABBVIE ENDOCRINE INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LUPRON DEPOT-PED~ABBVIE ENDOCRINE INC~3.
75MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not disco
ntinued or withdrawn for safety or efficacy reasons**~N~020263~003~~Apr 16, 1993
~No~DISCN~ABBVIE ENDOCRINE INC
5MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discon
tinued or withdrawn for safety or efficacy reasons**~N~020263~004~~Apr 16, 1993~
No~DISCN~ABBVIE ENDOCRINE INC
5MG/VIAL~N~020263~002~~Apr 16, 1993~Yes~RX~ABBVIE ENDOCRINE INC
LEUPROLIDE ACETATE~INJECTABLE;INJECTION~LUPRON DEPOT-PED~ABBVIE ENDOCRINE INC~11
.25MG/VIAL~N~020263~005~~Jan 21, 1994~Yes~RX~ABBVIE ENDOCRINE INC

.25MG/VIAL~N~020263~007~~Aug 15, 2011~Yes~RX~ABBVIE ENDOCRINE INC
MG/VIAL~N~020263~006~~Jan 21, 1994~Yes~RX~ABBVIE ENDOCRINE INC
MG/VIAL~N~020263~008~~Aug 15, 2011~Yes~RX~ABBVIE ENDOCRINE INC
GONADORELIN ACETATE~INJECTABLE;INJECTION~LUTREPULSE KIT~FERRING~0.8MG/VIAL~N~019
687~001~~Oct 10, 1989~No~DISCN~FERRING PHARMACEUTICALS INC
GONADORELIN ACETATE~INJECTABLE;INJECTION~LUTREPULSE KIT~FERRING~3.2MG/VIAL~N~019
687~002~~Oct 10, 1989~No~DISCN~FERRING PHARMACEUTICALS INC
ISOSULFAN BLUE~INJECTABLE;INJECTION~LYMPHAZURIN~COVIDIEN~1% **Federal Register d
cy reasons**~N~018310~001~~Approved Prior to Jan 1, 1982~No~DISCN~COVIDIEN
TECHNETIUM TC-99M TILMANOCEPT~INJECTABLE;INJECTION~LYMPHOSEEK KIT~NAVIDEA BIOPHA
RMS~N/A~N~202207~001~~Mar 13, 2013~Yes~RX~NAVIDEA BIOPHARMACEUTICALS INC
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~LYOPHILIZED CYTOXAN~BAXTER HLTHCARE~100MG/
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~LYOPHILIZED CYTOXAN~BAXTER HLTHCARE~200MG/
METHYLPREDNISOLONE ACETATE~INJECTABLE;INJECTION~M-PREDROL~BEL MAR~40MG/ML~A~0866
66~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
METHYLPREDNISOLONE ACETATE~INJECTABLE;INJECTION~M-PREDROL~BEL MAR~80MG/ML~A~0871
HYDROCHLORIDE; VITAMIN A; VITAMIN E~INJECTABLE;INJECTION~M.V.C. 9+3~ABRAXIS PHA
RM~10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36
MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML~N~018440~002~~Aug 8, 1985~No~DISCN~ABRAXIS P
HARMACEUTICAL PRODUCTS
HYDROCHLORIDE; VITAMIN A; VITAMIN E~INJECTABLE;INJECTION~M.V.I.-12~HOSPIRA~10MG
/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0
.3MG/ML;330 UNITS/ML;1 IU/ML~N~008809~004~~Aug 8, 1985~No~DISCN~HOSPIRA INC
NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITA
MIN A; VITAMIN E~INJECTABLE;INJECTION~M.V.I.-12~HOSPIRA~20MG/ML;0.006MG/ML;0.5MC
G/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;
1 IU/ML~N~008809~005~~Apr 22, 2004~No~DISCN~HOSPIRA INC
HYDROCHLORIDE; VITAMIN A; VITAMIN E~INJECTABLE;INJECTION~M.V.I.-12 (WITHOUT VIT
AMIN K)~HOSPIRA~20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG
/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML~N~008809~006~~Sep 9, 2004~Yes~RX
~HOSPIRA INC
NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; V
ITAMIN E~INJECTABLE;INJECTION~M.V.I.-12 LYOPHILIZED~ASTRAZENECA~100MG/VIAL;0.06M
G/VIAL;0.005MG/VIAL;15MG/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4MG/VIAL;3.6MG/VIAL
;3MG/VIAL;1MG/VIAL;10MG/VIAL~N~018933~002~~Aug 8, 1985~No~DISCN~ASTRAZENECA LP
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT~INJECTABLE;INJECTION~MACROTEC~BRACCO~N/
A~N~017833~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
MAGNESIUM SULFATE~INJECTABLE;INJECTION~MAGNESIUM SULFATE~EXELA PHARMA SCS LLC~50
0MG/ML~A~206039~001~AP~Dec 18, 2014~No~RX~EXELA PHARMA SCIENCES LLC
MAGNESIUM SULFATE~INJECTABLE;INJECTION~MAGNESIUM SULFATE~FRESENIUS KABI USA~500M
G/ML~N~019316~001~AP~Sep 8, 1986~Yes~RX~FRESENIUS KABI USA LLC
MAGNESIUM SULFATE~INJECTABLE;INJECTION~MAGNESIUM SULFATE~HOSPIRA~500MG/ML~A~0751
51~001~AP~Apr 25, 2000~Yes~RX~HOSPIRA INC
MAGNESIUM SULFATE~INJECTABLE;INJECTION~MAGNESIUM SULFATE IN DEXTROSE 5% IN PLAST
IC CONTAINER~HOSPIRA~1GM/100ML~N~020488~001~~Jul 11, 1995~Yes~RX~HOSPIRA INC
MAGNESIUM SULFATE~INJECTABLE;INJECTION~MAGNESIUM SULFATE IN DEXTROSE 5% IN PLAST

IC CONTAINER~HOSPIRA~2GM/100ML~N~020488~002~~Jul 11, 1995~Yes~RX~HOSPIRA INC
MAGNESIUM SULFATE~INJECTABLE;INJECTION~MAGNESIUM SULFATE IN PLASTIC CONTAINER~HO
SPIRA~2GM/50ML (40MG/ML)~N~020309~003~~Jan 26, 2007~No~RX~HOSPIRA INC
SPIRA~4GM/100ML (40MG/ML)~N~020309~001~~Jun 24, 1994~Yes~RX~HOSPIRA INC
SPIRA~4GM/50ML (80MG/ML)~N~020309~002~~Jun 24, 1994~Yes~RX~HOSPIRA INC
SPIRA~20GM/500ML (40MG/ML)~N~020309~004~~Jan 18, 1995~No~RX~HOSPIRA INC
SPIRA~40GM/1000ML(40MG/ML)~N~020309~005~~Jan 18, 1995~No~RX~HOSPIRA INC
GADOPENTETATE DIMEGLUMINE~INJECTABLE;INJECTION~MAGNEVIST~BAYER HLTHCARE~469.01MG
/ML~N~019596~001~~Jun 2, 1988~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
GADOPENTETATE DIMEGLUMINE~INJECTABLE;INJECTION~MAGNEVIST~BAYER HLTHCARE~469.01MG
/ML~N~021037~001~~Mar 10, 2000~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
CEFAMANDOLE NAFATE~INJECTABLE;INJECTION~MANDOL~LILLY~EQ 1GM BASE/VIAL~A~062560~0
CEFAMANDOLE NAFATE~INJECTABLE;INJECTION~MANDOL~LILLY~EQ 1GM BASE/VIAL~N~050504~0
CEFAMANDOLE NAFATE~INJECTABLE;INJECTION~MANDOL~LILLY~EQ 2GM BASE/VIAL~A~062560~0
CEFAMANDOLE NAFATE~INJECTABLE;INJECTION~MANDOL~LILLY~EQ 2GM BASE/VIAL~N~050504~0
CEFAMANDOLE NAFATE~INJECTABLE;INJECTION~MANDOL~LILLY~EQ 10GM BASE/VIAL~N~050504~
CEFAMANDOLE NAFATE~INJECTABLE;INJECTION~MANDOL~LILLY~EQ 500MG BASE/VIAL~N~050504
MANGANESE CHLORIDE~INJECTABLE;INJECTION~MANGANESE CHLORIDE IN PLASTIC CONTAINER~
HOSPIRA~EQ 0.1MG MANGANESE/ML~N~018962~001~~Jun 26, 1986~No~RX~HOSPIRA INC
MANGANESE SULFATE~INJECTABLE;INJECTION~MANGANESE SULFATE~ABRAXIS PHARM~EQ 0.1MG
MANGANESE/ML~N~019228~001~~May 5, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
MANNITOL~INJECTABLE;INJECTION~MANNITOL 10%~B BRAUN~10GM/100ML~N~016080~002~AP~Ap
proved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 10%~HOSPIRA~10GM/100ML~N~016269~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 10%~MILES~10GM/100ML~N~016472~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~MILES LABORATORIES INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 10% IN PLASTIC CONTAINER~B BRAUN~10GM/100
ML~N~020006~002~AP~Jul 26, 1993~No~RX~B BRAUN MEDICAL INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 10% IN PLASTIC CONTAINER~HOSPIRA~10GM/100
ML~N~019603~002~AP~Jan 8, 1987~No~RX~HOSPIRA INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER~B B
RAUN~10GM/100ML~N~016080~006~AP~Approved Prior to Jan 1, 1982~No~RX~B BRAUN MEDI
CAL INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.4
5%~B BRAUN~15GM/100ML~N~016080~005~AP~Approved Prior to Jan 1, 1982~No~RX~B BRAU
N MEDICAL INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 20%~B BRAUN~20GM/100ML~N~014738~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC

MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~ABRAXIS PHARM~12.5GM/50ML~A~086754~00
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~ASTRAZENECA~12.5GM/50ML~A~089239~001~
~May 6, 1987~No~DISCN~ASTRAZENECA LP
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~ASTRAZENECA~12.5GM/50ML~A~089240~001~
~May 6, 1987~No~DISCN~ASTRAZENECA LP
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~FRESENIUS KABI USA~12.5GM/50ML~A~0806
77~001~AP~Approved Prior to Jan 1, 1982~No~RX~FRESENIUS KABI USA LLC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~HOSPIRA~12.5GM/50ML~N~016269~005~~App
roved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~HOSPIRA~12.5GM/50ML~N~016269~006~AP~A
ug 25, 1994~No~RX~HOSPIRA INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~INTL MEDICATION~12.5GM/50ML~A~083051~
001~AP~Approved Prior to Jan 1, 1982~No~RX~INTERNATIONAL MEDICATION SYSTEM
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~LUITPOLD~12.5GM/50ML~A~087409~001~AP~
Jan 21, 1982~No~RX~LUITPOLD PHARMACEUTICALS INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~MERCK~12.5GM/50ML~N~005620~001~~Appro
MANNITOL~INJECTABLE;INJECTION~MANNITOL 25%~WATSON LABS~12.5GM/50ML~A~087460~001~
~Jun 27, 1983~No~DISCN~WATSON LABORATORIES INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 5%~B BRAUN~5GM/100ML~N~016080~001~AP~Appr
oved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 5%~HOSPIRA~5GM/100ML~N~016269~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML
~N~020006~001~AP~Jul 26, 1993~No~RX~B BRAUN MEDICAL INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML
~N~019603~001~AP~Jan 8, 1987~No~RX~HOSPIRA INC
MANNITOL~INJECTABLE;INJECTION~MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12
%~B BRAUN~5GM/100ML~N~016080~007~AP~Approved Prior to Jan 1, 1982~No~RX~B BRAUN
MEDICAL INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MARCAINE HYDROCHLORIDE~HOSPIRA~0.
25%~N~016964~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MARCAINE HYDROCHLORIDE~HOSPIRA~0.
5%~N~016964~006~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MARCAINE HYDROCHLORIDE PRESERVATI
VE FREE~HOSPIRA~0.25%~N~016964~012~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPI
RA INC
VE FREE~HOSPIRA~0.5%~N~016964~005~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIR
A INC
VE FREE~HOSPIRA~0.75%~N~016964~009~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPI
RA INC
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~MARCAINE
HYDROCHLORIDE W/ EPINEPHRINE~HOSPIRA~0.25%;0.0091MG/ML~N~016964~004~AP~Approved
Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
HYDROCHLORIDE W/ EPINEPHRINE~HOSPIRA~0.5%;0.0091MG/ML~N~016964~008~AP~Approved P
rior to Jan 1, 1982~Yes~RX~HOSPIRA INC

HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE~HOSPIRA~0.25%;0.0091MG/ML~N~01696
4~013~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
~007~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
CYCLIZINE LACTATE~INJECTABLE;INJECTION~MAREZINE~GLAXOSMITHKLINE~50MG/ML~N~009495
~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~MAXIPIME~HOSPIRA INC~EQ 1GM BASE/VIA
L~N~050679~002~AP~Jan 18, 1996~Yes~RX~HOSPIRA INC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~MAXIPIME~HOSPIRA INC~EQ 2GM BASE/VIA
L~N~050679~003~AP~Jan 18, 1996~Yes~RX~HOSPIRA INC
CEFEPIME HYDROCHLORIDE~INJECTABLE;INJECTION~MAXIPIME~HOSPIRA INC~EQ 500MG BASE/V
IAL~N~050679~001~AP~Jan 18, 1996~Yes~RX~HOSPIRA INC
DIATRIZOATE SODIUM~INJECTABLE;INJECTION~MD-50~MALLINCKRODT~50%~A~087075~001~~App
roved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~MD-60~MALLINCKROD
T~52%;8%~A~087074~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDIC
AL INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~MD-76~MALLINCKROD
T~66%;10%~A~087073~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDI
CAL INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~MD-76R~LIEBEL-FLA
RSHEIM~66%;10%~N~019292~001~AP~Sep 29, 1989~Yes~RX~LIEBEL-FLARSHEIM CO LLC
TECHNETIUM TC-99M MEDRONATE KIT~INJECTABLE;INJECTION~MDP-BRACCO~BRACCO~N/A~N~018
107~001~AP~Approved Prior to Jan 1, 1982~No~RX~BRACCO DIAGNOSTICS INC
MEDROXYPROGESTERONE ACETATE~INJECTABLE;INJECTION~MEDROXYPROGESTERONE ACETATE~SAN
DOZ~150MG/ML~A~078711~001~AB~May 20, 2009~No~RX~SANDOZ CANADA INC
MEDROXYPROGESTERONE ACETATE~INJECTABLE;INJECTION~MEDROXYPROGESTERONE ACETATE~TEV
A PHARMS USA~150MG/ML~A~076552~001~~Oct 27, 2004~No~DISCN~TEVA PHARMACEUTICALS U
SA
MEDROXYPROGESTERONE ACETATE~INJECTABLE;INJECTION~MEDROXYPROGESTERONE ACETATE~TEV
A PHARMS USA~150MG/ML~A~076553~001~AB~Jul 28, 2004~No~RX~TEVA PHARMACEUTICALS US
A
CEFOXITIN SODIUM~INJECTABLE;INJECTION~MEFOXIN~MYLAN INSTITUTIONAL~EQ 1GM BASE/VI
AL~A~062757~001~~Jan 8, 1987~No~DISCN~MYLAN INSTITUTIONAL LLC
AL~N~050517~001~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN INSTITUTIONAL LLC
AL~A~062757~002~~Jan 8, 1987~No~DISCN~MYLAN INSTITUTIONAL LLC
AL~N~050517~002~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN INSTITUTIONAL LLC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~MEFOXIN~MYLAN INSTITUTIONAL~EQ 10GM BASE/V
IAL~N~050517~003~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN INSTITUTIONAL LLC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINE
R~MERCK~EQ 20MG BASE/ML~N~050581~003~~Sep 20, 1984~No~DISCN~MERCK AND CO INC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINE
R~MERCK~EQ 40MG BASE/ML~N~050581~004~~Sep 20, 1984~No~DISCN~MERCK AND CO INC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~MEFOXIN IN PLASTIC CONTAINER~MYLAN INSTITU
TIONAL~EQ 20MG BASE/ML~A~063182~001~~Jan 25, 1993~Yes~RX~MYLAN INSTITUTIONAL LLC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~MEFOXIN IN PLASTIC CONTAINER~MYLAN INSTITU
TIONAL~EQ 40MG BASE/ML~A~063182~002~~Jan 25, 1993~Yes~RX~MYLAN INSTITUTIONAL LLC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC
CONTAINER~MERCK~EQ 20MG BASE/ML~N~050581~002~~Sep 20, 1984~No~DISCN~MERCK AND C
O INC
CEFOXITIN SODIUM~INJECTABLE;INJECTION~MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC
CONTAINER~MERCK~EQ 40MG BASE/ML~N~050581~001~~Sep 20, 1984~No~DISCN~MERCK AND C
O INC
ALBUMIN IODINATED I-131 SERUM~INJECTABLE;INJECTION~MEGATOPE~ISO TEX~0.5mCi/VIAL~
N~017837~001~~Approved Prior to Jan 1, 1982~Yes~RX~ISO TEX DIAGNOSTICS INC
ALBUMIN IODINATED I-131 SERUM~INJECTABLE;INJECTION~MEGATOPE~ISO TEX~1mCi/VIAL~N~
017837~002~~Approved Prior to Jan 1, 1982~Yes~RX~ISO TEX DIAGNOSTICS INC
ALBUMIN IODINATED I-131 SERUM~INJECTABLE;INJECTION~MEGATOPE~ISO TEX~2mCi/VIAL~N~
017837~003~~Approved Prior to Jan 1, 1982~No~DISCN~ISO TEX DIAGNOSTICS INC
ALBUMIN IODINATED I-131 SERUM~INJECTABLE;INJECTION~MEGATOPE~ISO TEX~5uCi/AMP~N~0
ALBUMIN IODINATED I-131 SERUM~INJECTABLE;INJECTION~MEGATOPE~ISO TEX~20uCi/AMP~N~
MELPHALAN HYDROCHLORIDE~INJECTABLE;INJECTION~MELPHALAN HYDROCHLORIDE~EUROHLTH IN
TL SARL~EQ 50MG BASE/VIAL~A~090303~001~AP~Oct 28, 2010~No~RX~EUROHEALTH INTERNAT
IONAL SARL
MELPHALAN HYDROCHLORIDE~INJECTABLE;INJECTION~MELPHALAN HYDROCHLORIDE~MYLAN INSTI
TUTIONAL~EQ 50MG BASE/VIAL~A~090270~001~AP~Jun 9, 2009~No~RX~MYLAN INSTITUTIONAL
LLC
MELPHALAN HYDROCHLORIDE~INJECTABLE;INJECTION~MELPHALAN HYDROCHLORIDE~MYLAN INSTI
TUTIONAL~EQ 50MG BASE/VIAL~A~090299~001~~Oct 27, 2009~No~DISCN~MYLAN INSTITUTION
AL LLC
MENOTROPINS (FSH;LH)~INJECTABLE;INJECTION~MENOTROPINS~FERRING~75 IU/VIAL;75 IU/V
IAL~A~073598~001~~Jan 30, 1997~No~DISCN~FERRING PHARMACEUTICALS INC
MENOTROPINS (FSH;LH)~INJECTABLE;INJECTION~MENOTROPINS~FERRING~150 IU/VIAL;150 IU
/VIAL~A~073599~001~~Jan 30, 1997~No~DISCN~FERRING PHARMACEUTICALS INC
MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERG
AN~BAXTER HLTHCARE CORP~25MG/ML;25MG/ML~N~011730~001~~Approved Prior to Jan 1, 1
982~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE AND A
TROPINE SULFATE~WYETH AYERST~0.4MG/ML;50MG/ML~A~085121~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
TROPINE SULFATE~WYETH AYERST~0.4MG/ML;75MG/ML~A~085121~002~~Approved Prior to Ja
TROPINE SULFATE~WYETH AYERST~0.4MG/ML;100MG/ML~A~085121~003~~Approved Prior to J
an 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~ABBOTT~25
MG/ML~A~080388~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES P
0MG/ML~A~080386~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES
PHARMACEUTICAL PRODUCTS DIV
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~ASTRAZENE
CA~25MG/ML~A~089781~001~~Mar 31, 1989~No~DISCN~ASTRAZENECA LP

MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~BAXTER HL
THCARE~25MG/ML~A~088279~001~~Jun 15, 1984~No~DISCN~BAXTER HEALTHCARE CORP ANESTH
ESIA AND CRITICAL CARE
THCARE~100MG/ML~A~088282~001~~Jun 15, 1984~No~DISCN~BAXTER HEALTHCARE CORP ANEST
HESIA AND CRITICAL CARE
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~EUROHLTH
INTL SARL~25MG/ML~A~080445~001~AP~Approved Prior to Jan 1, 1982~No~RX~EUROHEALTH
INTERNATIONAL SARL
INTERNATIONAL SARL
INTERNATIONAL SARL
INTL SARL~100MG/ML~A~080445~004~AP~Approved Prior to Jan 1, 1982~No~RX~EUROHEALT
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~HIKMA MAP
LE ~25MG/ML~A~080455~007~AP~Approved Prior to Jan 1, 1982~No~RX~HIKMA MAPLE LTD
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~INTL MEDI
CATION~10MG/ML~A~086332~001~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONA
L MEDICATION SYSTEMS LTD
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~PARKE DAV
IS~50MG/ML~A~080364~002~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV
WARNER LAMBERT CO
WARNER LAMBERT CO
WARNER LAMBERT CO
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~WATSON LA
BS~50MG/ML~A~073444~001~~Mar 17, 1992~No~DISCN~WATSON LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE~WATSON LA
BS~100MG/ML~A~073445~001~~Mar 17, 1992~No~DISCN~WATSON LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPERIDINE HYDROCHLORIDE PRESERVAT
IVE FREE~HIKMA MAPLE ~10MG/ML~A~081002~001~AP~Jul 30, 1993~No~RX~HIKMA MAPLE LTD
IVE FREE~HOSPIRA~10MG/ML~A~040305~001~~Mar 10, 1999~No~DISCN~HOSPIRA INC
IVE FREE~HOSPIRA~10MG/ML~A~088432~001~AP~Aug 16, 1984~Yes~RX~HOSPIRA INC

IVE FREE~INTL MEDICATION~10MG/ML~A~081309~001~~Aug 30, 1993~No~DISCN~INTERNATION
AL MEDICATION SYSTEM
IVE FREE~MALLINCKRODT~10MG/ML~A~040163~001~~May 12, 1997~No~DISCN~MALLINCKRODT C
HEMICAL INC
IVE FREE~WATSON LABS~10MG/ML~A~073443~001~~Mar 17, 1992~No~DISCN~WATSON LABORATO
RIES INC
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPIVACAINE HYDROCHLORIDE~GRAHAM
CHEM~3%~A~083559~001~~Approved Prior to Jan 1, 1982~No~DISCN~GRAHAM CHEMICAL CO
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPIVACAINE HYDROCHLORIDE~HOSPIRA
INC~3%~A~040806~001~AP~Apr 28, 2008~No~RX~HOSPIRA INC
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPIVACAINE HYDROCHLORIDE~INTL ME
DICATION~1%~A~087509~001~~Oct 5, 1982~No~DISCN~INTERNATIONAL MEDICATION SYSTEM
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPIVACAINE HYDROCHLORIDE~WATSON
LABS~1%~A~088769~001~~Nov 20, 1984~No~DISCN~WATSON LABORATORIES INC
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPIVACAINE HYDROCHLORIDE~WATSON
LABS~2%~A~088770~001~~Nov 20, 1984~No~DISCN~WATSON LABORATORIES INC
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~MEPIVACAINE HYDROC
HLORIDE W/ LEVONORDEFRIN~GRAHAM CHEM~0.05MG/ML;2%~A~084850~002~~Oct 21, 1983~No~
DISCN~GRAHAM CHEMICAL CO
MEROPENEM~INJECTABLE;INJECTION~MEROPENEM~ACS DOBFAR~1GM/VIAL~A~091404~002~AP~Oct
26, 2011~No~RX~ACS DOBFAR SPA
MEROPENEM~INJECTABLE;INJECTION~MEROPENEM~ACS DOBFAR~500MG/VIAL~A~091404~001~AP~O
ct 26, 2011~No~RX~ACS DOBFAR SPA
MEROPENEM~INJECTABLE;INJECTION~MEROPENEM~HOSPIRA INC~1GM/VIAL~A~090940~002~AP~Ju
n 22, 2010~No~RX~HOSPIRA INC
MEROPENEM~INJECTABLE;INJECTION~MEROPENEM~HOSPIRA INC~500MG/VIAL~A~090940~001~AP~
Jun 22, 2010~No~RX~HOSPIRA INC
MEROPENEM~INJECTABLE;INJECTION~MEROPENEM~SANDOZ~1GM/VIAL~A~091201~002~AP~Mar 29,
MEROPENEM~INJECTABLE;INJECTION~MEROPENEM~SANDOZ~500MG/VIAL~A~091201~001~AP~Mar 2
MEROPENEM~INJECTABLE;INJECTION~MERREM~ASTRAZENECA~1GM/VIAL~N~050706~001~AP~Jun 2
1, 1996~Yes~RX~ASTRAZENECA UK LTD
MEROPENEM~INJECTABLE;INJECTION~MERREM~ASTRAZENECA~500MG/VIAL~N~050706~003~AP~Jun
21, 1996~Yes~RX~ASTRAZENECA UK LTD
MERSALYL SODIUM; THEOPHYLLINE~INJECTABLE;INJECTION~MERSALYL-THEOPHYLLINE~WATSON
LABS~100MG/ML;50MG/ML~A~084875~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSO
N LABORATORIES INC
PYRIDOSTIGMINE BROMIDE~INJECTABLE;INJECTION~MESTINON~VALEANT PHARM INTL~5MG/ML~N
~009830~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTE
RNATIONAL
METARAMINOL BITARTRATE~INJECTABLE;INJECTION~METARAMINOL BITARTRATE~ABRAXIS PHARM
~EQ 10MG BASE/ML~A~080431~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PH
METARAMINOL BITARTRATE~INJECTABLE;INJECTION~METARAMINOL BITARTRATE~ELKINS SINN~E
Q 10MG BASE/ML~A~083363~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN
DIV AH ROBINS CO INC
METARAMINOL BITARTRATE~INJECTABLE;INJECTION~METARAMINOL BITARTRATE~FRESENIUS KAB
I USA~EQ 10MG BASE/ML~A~080722~001~~Approved Prior to Jan 1, 1982~Yes~RX~FRESENI
US KABI USA LLC
METARAMINOL BITARTRATE~INJECTABLE;INJECTION~METARAMINOL BITARTRATE~GD SEARLE LLC
~EQ 10MG BASE/ML~A~086418~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE
LLC
METARAMINOL BITARTRATE~INJECTABLE;INJECTION~METARAMINOL BITARTRATE~GD SEARLE LLC
~EQ 20MG BASE/ML~A~086418~002~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE
LLC
STRONTIUM CHLORIDE SR-89~INJECTABLE;INJECTION~METASTRON~GE HEALTHCARE~1mCi/ML~N~

020134~001~AP~Jun 18, 1993~Yes~RX~GE HEALTHCARE
METHYLERGONOVINE MALEATE~INJECTABLE;INJECTION~METHERGINE~EDISON THERAPS LLC~0.2M
G/ML~N~006035~004~AP~Approved Prior to Jan 1, 1982~Yes~RX~EDISON THERAPEUTICS LL
C
METHOCARBAMOL~INJECTABLE;INJECTION~METHOCARBAMOL~MARSAM PHARMS LLC~100MG/ML~A~08
9849~001~~Dec 27, 1991~No~DISCN~MARSAM PHARMACEUTICALS LLC
METHOCARBAMOL~INJECTABLE;INJECTION~METHOCARBAMOL~WATSON LABS~100MG/ML~A~086459~0
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE LPF~HOSPIRA~EQ 25MG BASE/M
L~N~011719~007~~Mar 31, 1982~No~DISCN~HOSPIRA INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE PRESERVATIVE FREE~FRESENIU
S KABI USA~EQ 1GM BASE/VIAL~A~040266~001~AP~Feb 26, 1999~No~RX~FRESENIUS KABI US
A LLC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE PRESERVATIVE FREE~FRESENIU
S KABI USA~EQ 25MG BASE/ML~A~040265~001~~Feb 26, 1999~No~DISCN~FRESENIUS KABI US
A LLC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE PRESERVATIVE FREE~HOSPIRA~
EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)~N~011719~011~~Apr 13, 2005~No~DISCN~HOSPIR
A INC
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)~N~011719~014~~Apr 13, 2005~No~DISCN~HOSPIRA I
NC
EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that produ
ct was not discontinued or withdrawn for safety or efficacy reasons**~N~011719~0
13~~Apr 13, 2005~No~DISCN~HOSPIRA INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE PRESERVATIVE FREE~PHARMACH
EMIE BV~EQ 100MG BASE/4ML (EQ 25MG BASE/ML)~A~200171~001~AP~Feb 27, 2012~No~RX~P
HARMACHEMIE BV
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~ABRAXIS PHARM~EQ 2.
5MG BASE/ML~A~089323~001~~Jun 13, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~ABRAXIS PHARM~EQ 20
MG BASE/VIAL~A~088935~001~~Oct 11, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
MG BASE/ML~A~089263~001~~Jun 13, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
MG BASE/ML~A~089322~001~~Jun 13, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
MG BASE/VIAL~A~088936~001~~Oct 11, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
0MG BASE/VIAL~A~088937~001~~Oct 11, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCT
S
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~EUROHLTH INTL SARL~
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)~A~089341~001~AP~Sep 16, 1986~Yes~RX~EUROHEAL
TH INTERNATIONAL SARL
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~EUROHLTH INTL SARL~
EQ 200MG BASE/8ML (EQ 25MG BASE/ML)~A~089342~001~~Sep 16, 1986~Yes~RX~EUROHEALTH
INTERNATIONAL SARL
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~FRESENIUS KABI USA~
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)~A~040263~001~AP~Feb 26, 1999~Yes~RX~FRESENIUS
KABI USA LLC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~FRESENIUS KABI USA~
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)~A~040263~002~AP~Feb 26, 1999~Yes~RX~FRESENI
US KABI USA LLC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~HOSPIRA~EQ 2.5MG BA
SE/ML~N~011719~004~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~HOSPIRA~EQ 20MG BAS
E/VIAL~N~011719~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
E/ML~N~011719~005~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC

E/VIAL~N~011719~003~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
E/2ML (EQ 25MG BASE/ML)~N~011719~010~AP~Dec 15, 2004~Yes~RX~HOSPIRA INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~HOSPIRA~EQ 100MG BA
SE/VIAL~N~011719~006~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~NORBROOK~EQ 25MG BA
SE/ML~A~088648~001~~May 9, 1986~No~DISCN~NORBROOK LABORATORIES LTD
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM~PHARMACHEMIE USA~EQ
25MG BASE/ML~A~089158~001~~Jul 8, 1988~No~DISCN~PHARMACHEMIE USA INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM PRESERVATIVE FREE~A
CCORD HLTHCARE~EQ 1GM BASE/40ML (EQ 25MG BASE/ML)~A~040716~001~AP~Apr 30, 2007~Y
es~RX~ACCORD HEALTHCARE INC
CCORD HLTHCARE~EQ 50MG BASE/2ML (EQ 25MG BASE/ML)~A~040767~001~AP~Apr 30, 2007~Y
es~RX~ACCORD HEALTHCARE INC
CCORD HLTHCARE~EQ 250MG BASE/10ML (EQ 25MG BASE/ML)~A~040768~001~AP~Apr 30, 2007
~Yes~RX~ACCORD HEALTHCARE INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM PRESERVATIVE FREE~E
BEWE PHARMA~EQ 1GM BASE/40ML (EQ 25MG BASE/ML)~A~090029~001~AP~Mar 31, 2009~No~R
X~EBEWE PHARMA GES MBH NFG KG
BEWE PHARMA~EQ 50MG BASE/2ML (EQ 25MG BASE/ML)~A~090039~001~AP~Mar 31, 2009~No~R
X~EBEWE PHARMA GES MBH NFG KG
BEWE PHARMA~EQ 250MG BASE/10ML (EQ 25MG BASE/ML)~A~090039~002~AP~Mar 31, 2009~No
~RX~EBEWE PHARMA GES MBH NFG KG
UROHLTH INTL SARL~EQ 1GM BASE/VIAL~A~040632~001~~Aug 12, 2005~Yes~RX~EUROHEALTH
INTERNATIONAL SARL
UROHLTH INTL SARL~EQ 50MG BASE/2ML (EQ 25MG BASE/ML)~A~089340~001~AP~Sep 16, 198
6~Yes~RX~EUROHEALTH INTERNATIONAL SARL
UROHLTH INTL SARL~EQ 250MG BASE/10ML (EQ 25MG BASE/ML)~A~089343~001~AP~Sep 16, 1
986~Yes~RX~EUROHEALTH INTERNATIONAL SARL
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM PRESERVATIVE FREE~H
OSPIRA~EQ 1GM BASE/VIAL~N~011719~009~~Apr 7, 1988~No~DISCN~HOSPIRA INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM PRESERVATIVE FREE~H
OSPIRA~EQ 1GM BASE/40ML (EQ 25MG BASE/ML)~N~011719~012~AP~Apr 13, 2005~Yes~RX~HO
SPIRA INC
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM PRESERVATIVE FREE~O
NCO THERAPIES LTD~EQ 1GM BASE/40ML (EQ 25MG BASE/ML)~A~201530~001~AP~Mar 29, 201
2~No~RX~ONCO THERAPIES LTD
NCO THERAPIES LTD~EQ 50MG BASE/2ML (EQ 25MG BASE/ML)~A~201529~001~AP~Mar 29, 201
METHOTREXATE SODIUM~INJECTABLE;INJECTION~METHOTREXATE SODIUM PRESERVATIVE FREE~P
HARMACHEMIE BV~EQ 1GM BASE/40ML (EQ 25MG BASE/ML)~A~040843~001~AP~Jan 11, 2010~N
o~RX~PHARMACHEMIE BV
HARMACHEMIE BV~EQ 50MG BASE/2ML (EQ 25MG BASE/ML)~A~040850~001~AP~Jan 11, 2010~N
o~RX~PHARMACHEMIE BV
HARMACHEMIE BV~EQ 250MG/10ML (EQ 25MG BASE/ML)~A~040853~001~AP~Jan 11, 2010~No~R
X~PHARMACHEMIE BV
METHYLDOPATE HYDROCHLORIDE~INJECTABLE;INJECTION~METHYLDOPATE HYDROCHLORIDE~ABRAX
IS PHARM~50MG/ML~A~070652~001~~Jun 3, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODU
CTS
METHYLDOPATE HYDROCHLORIDE~INJECTABLE;INJECTION~METHYLDOPATE HYDROCHLORIDE~BAXTE
R HLTHCARE~50MG/ML~A~070291~001~~Jul 1, 1986~No~DISCN~BAXTER HEALTHCARE CORP ANE
STHESIA AND CRITICAL CARE
METHYLDOPATE HYDROCHLORIDE~INJECTABLE;INJECTION~METHYLDOPATE HYDROCHLORIDE~HOSPI
RA~50MG/ML~A~070691~001~~Jun 19, 1987~No~DISCN~HOSPIRA INC
METHYLDOPATE HYDROCHLORIDE~INJECTABLE;INJECTION~METHYLDOPATE HYDROCHLORIDE~LUITP
OLD~50MG/ML~A~071279~001~AP~Oct 2, 1987~Yes~RX~LUITPOLD PHARMACEUTICALS INC
METHYLDOPATE HYDROCHLORIDE~INJECTABLE;INJECTION~METHYLDOPATE HYDROCHLORIDE~MARSA
M PHARMS LLC~50MG/ML~A~071812~001~~Dec 22, 1987~No~DISCN~MARSAM PHARMACEUTICALS
LLC
METHYLDOPATE HYDROCHLORIDE~INJECTABLE;INJECTION~METHYLDOPATE HYDROCHLORIDE~SMITH
AND NEPHEW~50MG/ML~A~070841~001~~Jan 2, 1987~No~DISCN~SMITH AND NEPHEW SOLOPAK
DIV SMITH AND NEPHEW
METHYLDOPATE HYDROCHLORIDE~INJECTABLE;INJECTION~METHYLDOPATE HYDROCHLORIDE~TEVA
PARENTERAL~50MG/ML~A~072974~001~~Nov 22, 1991~No~DISCN~TEVA PARENTERAL MEDICINES
INC
METHYLERGONOVINE MALEATE~INJECTABLE;INJECTION~METHYLERGONOVINE MALEATE~ERGOJECT~
0.2MG/ML~A~040889~001~AP~Sep 13, 2010~No~RX~ERGOJECT LLC
METHYLERGONOVINE MALEATE~INJECTABLE;INJECTION~METHYLERGONOVINE MALEATE~LUITPOLD~
0.2MG/ML~A~090193~001~AP~Nov 24, 2008~No~RX~LUITPOLD PHARMACEUTICALS INC
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE~ELKI
NS SINN~EQ 1GM BASE/VIAL~A~086906~004~~Approved Prior to Jan 1, 1982~No~DISCN~EL
KINS SINN DIV AH ROBINS CO INC
NS SINN~EQ 125MG BASE/VIAL~A~086906~002~~Approved Prior to Jan 1, 1982~No~DISCN~
ELKINS SINN DIV AH ROBINS CO INC
NS SINN~EQ 500MG BASE/VIAL~A~086906~003~~Approved Prior to Jan 1, 1982~No~DISCN~
ELKINS SINN DIV AH ROBINS CO INC
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE~ORGA
NON USA INC~EQ 1GM BASE/VIAL~A~087535~002~~Jun 25, 1982~No~DISCN~ORGANON USA INC
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE~ORGA
NON USA INC~EQ 500MG BASE/VIAL~A~087535~001~~Jun 25, 1982~No~DISCN~ORGANON USA I
NC
METHYLPREDNISOLONE ACETATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE ACETATE~AKORN
~40MG/ML~A~086903~001~~Oct 20, 1982~No~DISCN~AKORN INC
METHYLPREDNISOLONE ACETATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE ACETATE~AKORN
~80MG/ML~A~086903~002~~Oct 20, 1982~No~DISCN~AKORN INC
METHYLPREDNISOLONE ACETATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE ACETATE~SANDO
Z~40MG/ML~A~040719~001~AB~Jan 29, 2009~No~RX~SANDOZ CANADA INC
Z~40MG/ML~A~040794~001~AB~Mar 5, 2009~No~RX~SANDOZ CANADA INC
Z~80MG/ML~A~040719~002~AB~Jan 29, 2009~No~RX~SANDOZ CANADA INC

Z~80MG/ML~A~040794~002~AB~Mar 5, 2009~No~RX~SANDOZ CANADA INC
METHYLPREDNISOLONE ACETATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE ACETATE~TEVA
PHARMS USA~40MG/ML~A~040557~001~AB~Feb 23, 2005~No~RX~TEVA PHARMACEUTICALS USA
PHARMS USA~40MG/ML~A~040620~001~AB~Oct 27, 2006~No~RX~TEVA PHARMACEUTICALS USA
PHARMS USA~80MG/ML~A~040557~002~AB~Feb 23, 2005~No~RX~TEVA PHARMACEUTICALS USA
PHARMS USA~80MG/ML~A~040620~002~AB~Oct 27, 2006~No~RX~TEVA PHARMACEUTICALS USA
METHYLPREDNISOLONE ACETATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE ACETATE~WATSO
N LABS~20MG/ML~A~085597~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABOR
ATORIES INC
ATORIES INC
ATORIES INC
ATORIES INC
ATORIES INC
ATORIES INC
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~METHYLPREDNISOLONE SODI
UM SUCCINATE~ABRAXIS PHARM~EQ 1GM BASE/VIAL~A~088679~001~~Jun 8, 1984~No~DISCN~A
BRAXIS PHARMACEUTICAL PRODUCTS
UM SUCCINATE~ABRAXIS PHARM~EQ 1GM BASE/VIAL~A~089188~001~~Mar 28, 1986~No~DISCN~
ABRAXIS PHARMACEUTICAL PRODUCTS
UM SUCCINATE~ABRAXIS PHARM~EQ 1GM BASE/VIAL~A~089189~001~~Mar 28, 1986~No~DISCN~
UM SUCCINATE~ABRAXIS PHARM~EQ 40MG BASE/VIAL~A~088676~001~~Jun 8, 1984~No~DISCN~
UM SUCCINATE~ABRAXIS PHARM~EQ 40MG BASE/VIAL~A~089143~001~~Mar 28, 1986~No~DISCN
~ABRAXIS PHARMACEUTICAL PRODUCTS
UM SUCCINATE~ABRAXIS PHARM~EQ 125MG BASE/VIAL~A~088677~001~~Jun 8, 1984~No~DISCN
UM SUCCINATE~ABRAXIS PHARM~EQ 125MG BASE/VIAL~A~089144~001~~Mar 28, 1986~No~DISC
N~ABRAXIS PHARMACEUTICAL PRODUCTS
UM SUCCINATE~ABRAXIS PHARM~EQ 500MG BASE/VIAL~A~088678~001~~Jun 8, 1984~No~DISCN
UM SUCCINATE~BEDFORD LABS~EQ 1GM BASE/VIAL~A~040641~004~~Feb 21, 2007~No~DISCN~B
EDFORD LABORATORIES
UM SUCCINATE~BEDFORD LABS~EQ 1GM BASE/VIAL~A~040709~002~~Feb 21, 2007~No~DISCN~B
EDFORD LABORATORIES
UM SUCCINATE~BEDFORD LABS~EQ 40MG BASE/VIAL~A~040662~001~~Feb 21, 2007~No~DISCN~
BEDFORD LABORATORIES
UM SUCCINATE~BEDFORD LABS~EQ 125MG BASE/VIAL~A~040641~002~~Feb 21, 2007~No~DISCN
~BEDFORD LABORATORIES
UM SUCCINATE~ELKINS SINN~EQ 40MG BASE/VIAL~A~086906~001~~Approved Prior to Jan 1
, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
UM SUCCINATE~FRESENIUS KABI USA~EQ 1GM BASE/VIAL~A~040612~001~AP~Aug 12, 2004~No
UM SUCCINATE~FRESENIUS KABI USA~EQ 40MG BASE/VIAL~A~040583~001~AP~Jul 30, 2004~N
o~RX~FRESENIUS KABI USA LLC
UM SUCCINATE~FRESENIUS KABI USA~EQ 125MG BASE/VIAL~A~040583~002~AP~Jul 30, 2004~
No~RX~FRESENIUS KABI USA LLC
UM SUCCINATE~INTL MEDICATION~EQ 1GM BASE/VIAL~A~087852~001~~Feb 9, 1983~No~DISCN
~INTERNATIONAL MEDICATION SYSTEMS LTD
UM SUCCINATE~INTL MEDICATION~EQ 40MG BASE/VIAL~A~087812~001~~Feb 9, 1983~No~DISC
N~INTERNATIONAL MEDICATION SYSTEMS LTD
UM SUCCINATE~INTL MEDICATION~EQ 125MG BASE/VIAL~A~087813~001~~Feb 9, 1983~No~DIS
CN~INTERNATIONAL MEDICATION SYSTEMS LTD
UM SUCCINATE~INTL MEDICATION~EQ 500MG BASE/VIAL~A~087851~001~~Feb 9, 1983~No~DIS
CN~INTERNATIONAL MEDICATION SYSTEMS LTD
UM SUCCINATE~MUSTAFA NEVSAT~EQ 1GM BASE/VIAL~A~040888~004~AP~Jul 18, 2011~No~RX~
MUSTAFA NEVSAT ILAC SANAYII AS
UM SUCCINATE~MUSTAFA NEVSAT~EQ 2GM BASE/VIAL~A~040888~005~AP~Jul 18, 2011~No~RX~
MUSTAFA NEVSAT ILAC SANAYII AS
UM SUCCINATE~MUSTAFA NEVSAT~EQ 40MG BASE/VIAL~A~040888~001~AP~Jul 18, 2011~No~RX
~MUSTAFA NEVSAT ILAC SANAYII AS
UM SUCCINATE~MUSTAFA NEVSAT~EQ 125MG BASE/VIAL~A~040888~002~AP~Jul 18, 2011~No~R
X~MUSTAFA NEVSAT ILAC SANAYII AS
UM SUCCINATE~MUSTAFA NEVSAT~EQ 500MG BASE/VIAL~A~040888~003~AP~Jul 18, 2011~No~R
X~MUSTAFA NEVSAT ILAC SANAYII AS
UM SUCCINATE~TEVA PARENTERAL~EQ 1GM BASE/VIAL~A~081268~001~~Nov 30, 1992~No~DISC
N~TEVA PARENTERAL MEDICINES INC
UM SUCCINATE~TEVA PARENTERAL~EQ 125MG BASE/VIAL~A~081266~001~~Nov 30, 1992~No~DI
SCN~TEVA PARENTERAL MEDICINES INC

UM SUCCINATE~TEVA PARENTERAL~EQ 500MG BASE/VIAL~A~081267~001~~Nov 30, 1992~No~DI
SCN~TEVA PARENTERAL MEDICINES INC
UM SUCCINATE~WATSON LABS~EQ 1GM BASE/VIAL~A~088524~001~~Jul 24, 1984~No~DISCN~WA
UM SUCCINATE~WATSON LABS~EQ 40MG BASE/VIAL~A~086953~001~~Jul 22, 1982~No~DISCN~W
UM SUCCINATE~WATSON LABS~EQ 125MG BASE/VIAL~A~087030~001~~Jul 22, 1982~No~DISCN~
UM SUCCINATE~WATSON LABS~EQ 500MG BASE/VIAL~A~088523~001~~Jul 24, 1984~No~DISCN~
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~METICORTELONE~SCHERING~25MG/ML~N~01025
CORP
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~METOCLOPRAMIDE~EMCURE PHARMS L
TD~ EQ 5MG BASE/ML~A~204756~001~AP~Dec 20, 2013~No~RX~EMCURE PHARMACEUTICALS LTD
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~METOCLOPRAMIDE HYDROCHLORIDE~B
D RX~EQ 5MG BASE/ML~A~091392~001~AP~Apr 19, 2013~No~RX~BD RX INC
EDFORD~EQ 5MG BASE/ML~A~072155~001~~Mar 30, 1992~No~DISCN~BEDFORD LABORATORIES D
IV BEN VENUE LABORATORIES INC
EDFORD~EQ 5MG BASE/ML~A~072244~001~~Mar 30, 1992~No~DISCN~BEDFORD LABORATORIES D
EDFORD~EQ 5MG BASE/ML~A~072247~001~~May 18, 1992~No~DISCN~BEDFORD LABORATORIES D
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~METOCLOPRAMIDE HYDROCHLORIDE~H
OSPIRA~EQ 5MG BASE/ML~A~070505~001~~Jun 23, 1989~No~DISCN~HOSPIRA INC
OSPIRA~EQ 5MG BASE/ML~A~070506~001~~Jun 22, 1989~No~DISCN~HOSPIRA INC
OSPIRA~EQ 5MG BASE/ML~A~070847~001~~Nov 7, 1988~No~DISCN~HOSPIRA INC
OSPIRA~EQ 5MG BASE/ML~A~071291~001~~Mar 3, 1989~No~DISCN~HOSPIRA INC
OSPIRA~EQ 5MG BASE/ML~A~071990~001~~Jan 18, 1989~No~DISCN~HOSPIRA INC
OSPIRA~EQ 5MG BASE/ML~A~073117~001~~Jan 17, 1991~No~DISCN~HOSPIRA WORLDWIDE, INC
OSPIRA~EQ 5MG BASE/ML~A~073118~001~AP~Jan 17, 1991~No~RX~HOSPIRA INC
OSPIRA~EQ 5MG BASE/ML~A~074147~001~~Aug 2, 1996~No~DISCN~HOSPIRA INC
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~METOCLOPRAMIDE HYDROCHLORIDE~L
YPHOMED~EQ 10MG BASE/2ML~A~070293~001~~Jan 24, 1986~No~DISCN~LYPHOMED DIV FUJISA
WA USA INC
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~METOCLOPRAMIDE HYDROCHLORIDE~N
ORBROOK~EQ 10MG BASE/2ML~A~070892~001~~Aug 26, 1988~No~DISCN~NORBROOK LABORATORI
ES LTD
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~METOCLOPRAMIDE HYDROCHLORIDE~S
MITH AND NEPHEW~EQ 5MG BASE/ML~A~070623~001~~Mar 2, 1987~No~DISCN~SMITH AND NEPH
EW SOLOPAK DIV SMITH AND NEPHEW
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~METOCLOPRAMIDE HYDROCHLORIDE~S
MITH AND NEPHEW~EQ 10MG BASE/2ML~A~070622~001~~Mar 2, 1987~No~DISCN~SMITH AND NE
PHEW SOLOPAK DIV SMITH AND NEPHEW
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~METOCLOPRAMIDE HYDROCHLORIDE~T

EVA PHARMS USA~EQ 5MG BASE/ML~A~073135~001~AP~Nov 27, 1991~No~RX~TEVA PHARMACEUT
ICALS USA
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~BEDFORD LABS~1MG/ML
~A~076495~001~AP~Jul 7, 2003~No~RX~BEDFORD LABORATORIES
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~CLARIS LIFESCIENCES
~1MG/ML~A~078950~001~AP~Apr 29, 2013~No~RX~CLARIS LIFESCIENCES LTD
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~FRESENIUS KABI USA~
1MG/ML~A~091045~001~AP~Oct 25, 2010~No~RX~FRESENIUS KABI USA LLC
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~GLAND PHARMA LTD~1M
G/ML~A~204205~001~AP~Aug 27, 2014~No~RX~GLAND PHARMA LTD
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~HIKMA FARMACEUTICA~
1MG/ML~A~077761~001~AP~May 30, 2007~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~HOSPIRA~1MG/ML~A~07
4133~001~AP~Dec 21, 1993~No~RX~HOSPIRA INC
5160~001~AP~Jul 6, 1998~No~RX~HOSPIRA INC
8085~001~AP~Apr 29, 2008~No~RX~HOSPIRA INC
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~LUITPOLD~1MG/ML~A~0
90386~001~AP~Sep 30, 2009~No~RX~LUITPOLD PHARMACEUTICALS INC
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~LUITPOLD~1MG/ML~A~0
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~SAGENT STRIDES~1MG/
ML~A~090317~001~AP~Apr 19, 2010~No~RX~SAGENT STRIDES LLC
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~SANDOZ~1MG/ML~A~077
360~001~AP~Oct 2, 2007~No~RX~SANDOZ CANADA INC
METOPROLOL TARTRATE~INJECTABLE;INJECTION~METOPROLOL TARTRATE~WATSON LABS~1MG/ML~
A~074032~001~~Dec 21, 1993~No~DISCN~WATSON LABORATORIES INC
METRONIDAZOLE~INJECTABLE;INJECTION~METRO I.V.~B BRAUN~500MG/100ML~N~018674~001~~
Aug 31, 1982~No~DISCN~B BRAUN MEDICAL INC
METRONIDAZOLE~INJECTABLE;INJECTION~METRO I.V. IN PLASTIC CONTAINER~B BRAUN~500MG
/100ML~N~018900~001~AP~Sep 29, 1983~Yes~RX~B BRAUN MEDICAL INC
METRONIDAZOLE~INJECTABLE;INJECTION~METRONIDAZOLE~ABBOTT~500MG/100ML~N~018889~001
~~Nov 18, 1983~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
METRONIDAZOLE~INJECTABLE;INJECTION~METRONIDAZOLE~ABRAXIS PHARM~500MG/100ML~A~070
071~001~~Dec 3, 1984~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
METRONIDAZOLE~INJECTABLE;INJECTION~METRONIDAZOLE~HIKMA MAPLE ~500MG/100ML~N~0189
07~001~~Mar 30, 1984~No~DISCN~HIKMA MAPLE LTD
METRONIDAZOLE~INJECTABLE;INJECTION~METRONIDAZOLE~INTL MEDICATION~500MG/100ML~A~0
70004~001~~May 8, 1985~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
METRONIDAZOLE~INJECTABLE;INJECTION~METRONIDAZOLE~WATSON LABS~500MG/100ML~A~07004
METRONIDAZOLE~INJECTABLE;INJECTION~METRONIDAZOLE~WATSON LABS~500MG/100ML~A~07017
0~001~~Apr 1, 1986~No~DISCN~WATSON LABORATORIES INC
METRONIDAZOLE HYDROCHLORIDE~INJECTABLE;INJECTION~METRONIDAZOLE HYDROCHLORIDE~ABR
AXIS PHARM~EQ 500MG BASE/VIAL~A~070295~001~~Oct 15, 1985~No~DISCN~ABRAXIS PHARMA
CEUTICAL PRODUCTS
METRONIDAZOLE~INJECTABLE;INJECTION~METRONIDAZOLE IN PLASTIC CONTAINER~CLARIS LIF
ESCIENCES~500MG/100ML~A~078084~001~AP~Mar 31, 2008~No~RX~CLARIS LIFESCIENCES LTD
METRONIDAZOLE~INJECTABLE;INJECTION~METRONIDAZOLE IN PLASTIC CONTAINER~HOSPIRA~50
0MG/100ML~N~018890~002~AP~Nov 18, 1983~Yes~RX~HOSPIRA INC
METOCURINE IODIDE~INJECTABLE;INJECTION~METUBINE IODIDE~LILLY~2MG/ML~N~006632~003
~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
METHOTREXATE SODIUM~INJECTABLE;INJECTION~MEXATE~BRISTOL~EQ 20MG BASE/VIAL~A~0863
TOL MYERS CO
TOL MYERS CO

358~003~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRI
STOL MYERS CO
358~004~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRI
STOL MYERS CO
METHOTREXATE SODIUM~INJECTABLE;INJECTION~MEXATE-AQ~BRISTOL MYERS~EQ 25MG BASE/ML
~A~088760~001~~Feb 14, 1985~No~DISCN~BRISTOL MYERS CO
METHOTREXATE SODIUM~INJECTABLE;INJECTION~MEXATE-AQ PRESERVED~BRISTOL MYERS SQUIB
B~EQ 25MG BASE/ML~A~089887~001~~Apr 14, 1989~No~DISCN~BRISTOL MYERS SQUIBB
MEZLOCILLIN SODIUM MONOHYDRATE~INJECTABLE;INJECTION~MEZLIN~BAYER PHARMS~EQ 1GM B
ASE/VIAL~A~062333~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTIC
ALS CORP
ASE/VIAL~A~062372~005~~Jan 13, 1983~No~DISCN~BAYER PHARMACEUTICALS CORP
ASE/VIAL~N~050549~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTIC
ALS CORP
ALS CORP
ASE/VIAL~A~062372~001~~May 13, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
ALS CORP
ALS CORP
ALS CORP
ALS CORP
ALS CORP
MEZLOCILLIN SODIUM MONOHYDRATE~INJECTABLE;INJECTION~MEZLIN~BAYER PHARMS~EQ 20GM
BASE/VIAL~A~062372~004~~Mar 2, 1988~No~DISCN~BAYER PHARMACEUTICALS CORP
MEZLOCILLIN SODIUM MONOHYDRATE~INJECTABLE;INJECTION~MEZLIN~BAYER PHARMS~EQ 20GM
BASE/VIAL~N~050549~005~~Mar 2, 1988~No~DISCN~BAYER PHARMACEUTICALS CORP
CALCITONIN SALMON~INJECTABLE;INJECTION~MIACALCIN~SEBELA IRELAND LTD~100 IU/ML~N~
017808~001~~Jul 3, 1986~No~DISCN~SEBELA IRELAND LTD
CALCITONIN SALMON~INJECTABLE;INJECTION~MIACALCIN~SEBELA IRELAND LTD~200 IU/ML~N~
017808~002~~Mar 29, 1991~Yes~RX~SEBELA IRELAND LTD
TECHNETIUM TC-99M ALBUMIN COLLOID KIT~INJECTABLE;INJECTION~MICROLITE~PHARMALUCEN
CE~N/A~N~018263~001~~Mar 25, 1983~No~DISCN~PHARMALUCENCE INC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~AKORN INC~E
Q 1MG BASE/ML~A~075494~001~AP~Jun 30, 2000~No~RX~AKORN INC

MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~APOTEX INC~
EQ 1MG BASE/ML~A~075637~001~~Oct 31, 2000~No~DISCN~APOTEX INC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~APOTEX INC~
EQ 5MG BASE/ML~A~075637~002~~Oct 31, 2000~No~DISCN~APOTEX INC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~APOTHECON~E
Q 1MG BASE/ML~A~075620~001~~Nov 1, 2000~No~DISCN~APOTHECON INC DIV BRISTOL MYERS
SQUIBB
Q 5MG BASE/ML~A~075620~002~~Nov 1, 2000~No~DISCN~APOTHECON INC DIV BRISTOL MYERS
SQUIBB
Q 5MG BASE/ML~A~075641~001~~Oct 19, 2000~No~DISCN~APOTHECON INC DIV BRISTOL MYER
S SQUIBB
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~ASTRAZENECA
~EQ 5MG BASE/ML~A~075263~001~~Jun 26, 2000~No~DISCN~ASTRAZENECA PHARMACEUTICALS
LP
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~BEDFORD~EQ
1MG BASE/ML~A~075247~002~AP~Jun 23, 2000~No~RX~BEDFORD LABORATORIES DIV BEN VENU
E LABORATORIES INC
5MG BASE/ML~A~075247~001~AP~Jun 23, 2000~No~RX~BEDFORD LABORATORIES DIV BEN VENU
E LABORATORIES INC
5MG BASE/ML~A~075249~001~~Jun 23, 2000~No~DISCN~BEDFORD LABORATORIES DIV BEN VEN
UE LABORATORIES INC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~BEDFORD LAB
S~EQ 1MG BASE/ML~A~075421~002~AP~Jun 20, 2000~No~RX~BEDFORD LABORATORIES
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~BEDFORD LAB
S~EQ 5MG BASE/ML~A~075421~001~AP~Jun 20, 2000~No~RX~BEDFORD LABORATORIES
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~BEN VENUE~E
Q 5MG BASE/ML~A~075455~001~~Jun 20, 2000~No~DISCN~BEN VENUE LABORATORIES INC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~FRESENIUS K
ABI USA~EQ 1MG BASE/ML~A~075154~002~AP~Jun 20, 2000~No~RX~FRESENIUS KABI USA LLC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~FRESENIUS K
ABI USA~EQ 5MG BASE/ML~A~075154~001~AP~Jun 20, 2000~No~RX~FRESENIUS KABI USA LLC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~GLAND PHARM
A LTD~EQ 1MG BASE/ML~A~090696~001~AP~Feb 29, 2012~No~RX~GLAND PHARMA LTD
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~GLAND PHARM
A LTD~EQ 5MG BASE/ML~A~090850~001~AP~Jan 25, 2012~No~RX~GLAND PHARMA LTD
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~HIKMA MAPLE
~EQ 1MG BASE/ML~A~075243~001~AP~Jun 20, 2000~No~RX~HIKMA MAPLE LTD
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~HOSPIRA~EQ
1MG BASE/ML~A~075293~001~AP~Jun 20, 2000~Yes~RX~HOSPIRA INC
1MG BASE/ML~A~075396~001~~Jun 20, 2000~No~DISCN~HOSPIRA INC
5MG BASE/ML~A~075293~002~AP~Jun 20, 2000~Yes~RX~HOSPIRA INC

MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~HOSPIRA INC
~EQ 1MG BASE/ML~A~075409~002~~Jun 20, 2000~No~DISCN~HOSPIRA INC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~HOSPIRA INC
~EQ 5MG BASE/ML~A~075409~001~~Jun 20, 2000~No~DISCN~HOSPIRA INC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~INTL MEDICA
TED~EQ 1MG BASE/ML~A~076144~001~~Jan 26, 2005~No~DISCN~INTERNATIONAL MEDICATED S
YSTEMS LTD
TED~EQ 5MG BASE/ML~A~076144~002~~Jan 26, 2005~No~DISCN~INTERNATIONAL MEDICATED S
YSTEMS LTD
TION~EQ 1MG BASE/ML~A~076020~001~~Jul 16, 2004~No~DISCN~INTERNATIONAL MEDICATION
SYSTEMS LTD
TION~EQ 5MG BASE/ML~A~076020~002~~Jul 16, 2004~No~DISCN~INTERNATIONAL MEDICATION
SYSTEMS LTD
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE~WOCKHARDT~E
Q 1MG BASE/ML~A~078141~001~AP~May 30, 2008~No~RX~WOCKHARDT LTD
Q 1MG BASE/ML~A~078511~001~AP~Nov 10, 2008~No~RX~WOCKHARDT LTD
Q 5MG BASE/ML~A~078141~002~AP~May 30, 2008~No~RX~WOCKHARDT LTD
Q 5MG BASE/ML~A~078511~002~AP~Nov 10, 2008~No~RX~WOCKHARDT LTD
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDAZOLAM HYDROCHLORIDE PRESERVATIV
E FREE~BD RX~EQ 1MG BASE/ML~A~203460~001~AP~Aug 22, 2014~No~RX~BD RX INC
E FREE~BD RX~EQ 5MG BASE/ML~A~203460~002~AP~Aug 22, 2014~No~RX~BD RX INC
E FREE~HOSPIRA~EQ 1MG BASE/ML~A~075857~001~AP~Jul 22, 2002~Yes~RX~HOSPIRA INC
E FREE~HOSPIRA~EQ 5MG BASE/ML~A~075857~002~AP~Jul 22, 2002~Yes~RX~HOSPIRA INC
E FREE~SAGENT STRIDES~EQ 1MG BASE/ML~A~090315~001~AP~Nov 29, 2010~No~RX~SAGENT S
TRIDES LLC
E FREE~SAGENT STRIDES~EQ 5MG BASE/ML~A~090315~002~AP~Nov 29, 2010~No~RX~SAGENT S
TRIDES LLC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDOZALAM HYDROCHLORIDE~SAGENT STRI
DES~EQ 1MG BASE/ML~A~090316~001~AP~May 4, 2011~No~RX~SAGENT STRIDES LLC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~MIDOZALAM HYDROCHLORIDE~SAGENT STRI
DES~EQ 5MG BASE/ML~A~090316~002~AP~May 4, 2011~No~RX~SAGENT STRIDES LLC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~APOTEX INC~EQ 1MG BASE/
ML~A~076427~001~~Sep 21, 2004~No~DISCN~APOTEX INC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~BEDFORD~EQ 1MG BASE/ML~
A~075660~001~AP~May 28, 2002~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORI
ES INC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~FRESENIUS KABI USA~EQ 1
MG BASE/ML~A~075936~001~AP~May 28, 2002~No~RX~FRESENIUS KABI USA LLC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~GLAND PHARMA LTD~EQ 1MG
BASE/ML~A~077190~001~AP~Oct 31, 2006~No~RX~GLAND PHARMA LTD
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~HIKMA FARMACEUTICA~EQ 1
MG BASE/ML~A~077966~001~AP~Dec 3, 2010~Yes~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~HIKMA MAPLE ~EQ 1MG BAS
E/ML~A~075530~001~AP~May 28, 2002~No~RX~HIKMA MAPLE LTD
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~HIKMA MAPLE ~EQ 1MG BAS
E/ML~A~075852~001~~May 28, 2002~No~DISCN~HIKMA MAPLE LTD
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~HOSPIRA~EQ 1MG BASE/ML~

A~075830~001~~May 28, 2002~No~DISCN~HOSPIRA INC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~HOSPIRA~EQ 1MG BASE/ML~
A~075884~001~~May 28, 2002~No~DISCN~HOSPIRA WORLDWIDE, INC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~HOSPIRA INC~EQ 1MG BASE
/ML~A~203280~001~AP~Sep 3, 2014~No~RX~HOSPIRA INC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~INTL MEDICATED~EQ 1MG B
ASE/ML~A~076013~001~AP~Aug 2, 2002~No~RX~INTERNATIONAL MEDICATED SYSTEMS LTD
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE~MYLAN INSTITUTIONAL~EQ
1MG BASE/ML~A~076428~001~~Jun 16, 2003~No~DISCN~MYLAN INSTITUTIONAL LLC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE IN DEXTROSE 5%~APOTEX I
NC~EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)~A~077151~002~AP~Jul 20, 2005~No~RX~APOT
EX INC
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE IN DEXTROSE 5% IN PLAST
IC CONTAINER~APOTEX INC~EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)~A~077151~001~~Jul
IC CONTAINER~B BRAUN~EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)~A~076414~001~AP~Aug 1
IC CONTAINER~BAXTER HLTHCARE~EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)~A~075834~001~
AP~May 28, 2002~Yes~RX~BAXTER HEALTHCARE CORP
~Aug 8, 2002~No~DISCN~BAXTER HEALTHCARE CORP
AP~May 28, 2002~Yes~RX~BAXTER HEALTHCARE CORP
IC CONTAINER~BEDFORD LABS~EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)~A~078113~001~AP~
May 21, 2008~No~RX~BEDFORD LABORATORIES
IC CONTAINER~BEDFORD LABS~EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)~A~078113~002~AP~
May 21, 2008~No~RX~BEDFORD LABORATORIES
IC CONTAINER~HIKMA MAPLE ~EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)~A~075510~001~~Ma
y 28, 2002~No~DISCN~HIKMA MAPLE LTD
IC CONTAINER~HOSPIRA~EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)~A~075885~001~AP~May 2
IC CONTAINER~HOSPIRA~EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)~A~075885~002~AP~May 2
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE IN PLASTIC CONTAINER~HI
KMA FARMACEUTICA~EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)~A~090038~001~AP~Jan 21, 2
010~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
MILRINONE LACTATE~INJECTABLE;INJECTION~MILRINONE LACTATE IN PLASTIC CONTAINER~HI
KMA FARMACEUTICA~EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)~A~090038~002~AP~Jan 21, 2
010~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
MINOCYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~MINOCIN~LEDERLE~EQ 100MG BASE/VIA
MINOCYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~MINOCIN~REMPEX PHARMS INC~EQ 100M
G BASE/VIAL~N~050444~001~~Approved Prior to Jan 1, 1982~Yes~RX~REMPEX PHARMACEUT
ICALS INC
TECHNETIUM TC-99M SESTAMIBI KIT~INJECTABLE;INJECTION~MIRALUMA~LANTHEUS MEDCL~N/A
~N~019785~003~~May 23, 1997~No~DISCN~LANTHEUS MEDICAL IMAGING INC
PLICAMYCIN~INJECTABLE;INJECTION~MITHRACIN~PFIZER~2.5MG/VIAL~N~050109~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
MITOMYCIN~INJECTABLE;INJECTION~MITOMYCIN~ACCORD HLTHCARE~5MG/VIAL~A~064144~001~A
P~Apr 30, 1998~Yes~RX~ACCORD HEALTHCARE INC

MITOMYCIN~INJECTABLE;INJECTION~MITOMYCIN~ACCORD HLTHCARE~20MG/VIAL~A~064144~002~
AP~Apr 30, 1998~Yes~RX~ACCORD HEALTHCARE INC
MITOMYCIN~INJECTABLE;INJECTION~MITOMYCIN~ACCORD HLTHCARE~40MG/VIAL~A~064144~003~
AP~Aug 11, 2009~Yes~RX~ACCORD HEALTHCARE INC
MITOMYCIN~INJECTABLE;INJECTION~MITOMYCIN~BEDFORD~5MG/VIAL~A~064117~001~AP~Apr 19
, 1995~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
MITOMYCIN~INJECTABLE;INJECTION~MITOMYCIN~BEDFORD~20MG/VIAL~A~064117~002~AP~Apr 1
MITOMYCIN~INJECTABLE;INJECTION~MITOMYCIN~HIKMA MAPLE ~5MG/VIAL~A~064180~001~AP~D
ec 23, 1999~No~RX~HIKMA MAPLE LTD
MITOMYCIN~INJECTABLE;INJECTION~MITOMYCIN~HIKMA MAPLE ~20MG/VIAL~A~064180~002~AP~
Dec 23, 1999~No~RX~HIKMA MAPLE LTD
MITOMYCIN~INJECTABLE;INJECTION~MITOMYCIN~HOSPIRA~20MG/VIAL~A~064106~001~~Nov 29,
MITOXANTRONE HYDROCHLORIDE~INJECTABLE;INJECTION~MITOXANTRONE HYDROCHLORIDE~EUROH
LTH INTL SARL~EQ 20MG BASE/10ML (EQ 2MG BASE/ML)~A~076611~001~AP~Apr 11, 2006~No
~RX~EUROHEALTH INTERNATIONAL SARL
LTH INTL SARL~EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)~A~076611~002~AP~Apr 11, 2006~
No~RX~EUROHEALTH INTERNATIONAL SARL
LTH INTL SARL~EQ 30MG BASE/15ML (EQ 2MG BASE/ML)~A~076611~003~AP~Apr 11, 2006~No
~RX~EUROHEALTH INTERNATIONAL SARL
MITOXANTRONE HYDROCHLORIDE~INJECTABLE;INJECTION~MITOXANTRONE HYDROCHLORIDE~FRESE
NIUS KABI ONCOL~EQ 20MG BASE/10ML (EQ 2MG BASE/ML)~A~078606~001~~May 14, 2008~No
~DISCN~FRESENIUS KABI ONCOLOGY PLC
NIUS KABI ONCOL~EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)~A~078606~002~~May 14, 2008~
No~DISCN~FRESENIUS KABI ONCOLOGY PLC
NIUS KABI ONCOL~EQ 30MG BASE/15ML (EQ 2MG BASE/ML)~A~078606~003~~May 14, 2008~No
~DISCN~FRESENIUS KABI ONCOLOGY PLC
NIUS KABI USA~EQ 20MG BASE/10ML (EQ 2MG BASE/ML)~A~077496~001~AP~Apr 11, 2006~No
NIUS KABI USA~EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)~A~077496~002~AP~Apr 11, 2006~
No~RX~FRESENIUS KABI USA LLC
NIUS KABI USA~EQ 30MG BASE/15ML (EQ 2MG BASE/ML)~A~077496~003~AP~Apr 11, 2006~No
MITOXANTRONE HYDROCHLORIDE~INJECTABLE;INJECTION~MITOXANTRONE HYDROCHLORIDE~HOSPI
RA~EQ 20MG BASE/10ML (EQ 2MG BASE/ML)~A~076871~001~AP~Apr 11, 2006~Yes~RX~HOSPIR
A WORLDWIDE, INC
RA~EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)~A~076871~002~AP~Apr 11, 2006~Yes~RX~HOSP
IRA WORLDWIDE, INC
RA~EQ 30MG BASE/15ML (EQ 2MG BASE/ML)~A~076871~003~AP~Apr 11, 2006~Yes~RX~HOSPIR
A WORLDWIDE, INC
MITOXANTRONE HYDROCHLORIDE~INJECTABLE;INJECTION~MITOXANTRONE HYDROCHLORIDE~MYLAN
INSTITUTIONAL~EQ 20MG BASE/10ML (EQ 2MG BASE/ML)~A~078980~001~AP~Apr 13, 2009~N
o~RX~MYLAN INSTITUTIONAL LLC
MITOXANTRONE HYDROCHLORIDE~INJECTABLE;INJECTION~MITOXANTRONE HYDROCHLORIDE~MYLAN
INSTITUTIONAL~EQ 30MG BASE/15ML (EQ 2MG BASE/ML)~A~078980~002~AP~Apr 13, 2009~N
o~RX~MYLAN INSTITUTIONAL LLC
MITOXANTRONE HYDROCHLORIDE~INJECTABLE;INJECTION~MITOXANTRONE HYDROCHLORIDE~ONCO
THERAPIES LTD~EQ 20MG BASE/10ML (EQ 2MG BASE/ML)~A~201014~001~AP~Dec 11, 2012~No
~RX~ONCO THERAPIES LTD
MITOXANTRONE HYDROCHLORIDE~INJECTABLE;INJECTION~MITOXANTRONE HYDROCHLORIDE~TEVA

PHARMS USA~EQ 20MG BASE/10ML (EQ 2MG BASE/ML)~A~077356~001~AP~Apr 11, 2006~No~RX
PHARMS USA~EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)~A~077356~002~AP~Apr 11, 2006~No~
PHARMS USA~EQ 30MG BASE/15ML (EQ 2MG BASE/ML)~A~077356~003~AP~Apr 11, 2006~No~RX
MITOMYCIN~INJECTABLE;INJECTION~MITOZYTREX~SUPERGEN~5MG/VIAL~N~050763~001~~Nov 14
, 2002~No~DISCN~SUPERGEN INC
MIVACURIUM CHLORIDE~INJECTABLE;INJECTION~MIVACRON IN DEXTROSE 5% IN PLASTIC CONT
AINER~ABBVIE~EQ 0.5MG BASE/ML~N~020098~002~~Jan 22, 1992~No~DISCN~ABBVIE INC
MIVACURIUM CHLORIDE~INJECTABLE;INJECTION~MIVACRON IN DEXTROSE 5% IN PLASTIC CONT
AINER~ABBVIE~EQ 50MG BASE/100ML~N~020098~003~~Jan 22, 1992~No~DISCN~ABBVIE INC
MIVACURIUM CHLORIDE~INJECTABLE;INJECTION~MIVACURIUM CHLORIDE~AGILA SPECLTS~EQ 2M
G BASE/ML~A~078562~001~~Apr 30, 2009~No~DISCN~AGILA SPECIALTIES PRIVATE LTD
INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED
HUMAN~INJECTABLE;INJECTION~MIXTARD HUMAN 70/30~BAYER PHARMS~30 UNITS/ML;70 UNIT
S/ML~N~019585~001~~Mar 11, 1988~No~DISCN~BAYER PHARMACEUTICALS CORP
MICONAZOLE~INJECTABLE;INJECTION~MONISTAT~JANSSEN PHARMA~10MG/ML~N~018040~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~JANSSEN PHARMACEUTICA PRODUCTS LP
CEFONICID SODIUM~INJECTABLE;INJECTION~MONOCID~GLAXOSMITHKLINE~EQ 1GM BASE/VIAL~A
~063295~001~~Jul 26, 1993~No~DISCN~GLAXOSMITHKLINE
CEFONICID SODIUM~INJECTABLE;INJECTION~MONOCID~GLAXOSMITHKLINE~EQ 1GM BASE/VIAL~N
~050579~002~~May 23, 1984~No~DISCN~GLAXOSMITHKLINE
CEFONICID SODIUM~INJECTABLE;INJECTION~MONOCID~GLAXOSMITHKLINE~EQ 2GM BASE/VIAL~N
~050579~003~~May 23, 1984~No~DISCN~GLAXOSMITHKLINE
CEFONICID SODIUM~INJECTABLE;INJECTION~MONOCID~GLAXOSMITHKLINE~EQ 10GM BASE/VIAL~
N~050579~004~~May 23, 1984~No~DISCN~GLAXOSMITHKLINE
CEFONICID SODIUM~INJECTABLE;INJECTION~MONOCID~GLAXOSMITHKLINE~EQ 500MG BASE/VIAL
~N~050579~001~~May 23, 1984~No~DISCN~GLAXOSMITHKLINE
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~HOSPIRA~0.5MG/ML~A~071849
~001~AP~May 11, 1988~No~RX~HOSPIRA INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~HOSPIRA~0.5MG/ML~A~073509
~001~AP~Sep 30, 1992~No~RX~HOSPIRA INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~HOSPIRA~0.5MG/ML~N~019917
~001~~Oct 30, 1992~No~DISCN~HOSPIRA INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~HOSPIRA~1MG/ML~A~071850~0
01~AP~May 11, 1988~No~RX~HOSPIRA INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~HOSPIRA~1MG/ML~A~073510~0
01~AP~Sep 30, 1992~No~RX~HOSPIRA INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~HOSPIRA~1MG/ML~N~019916~0
01~AP~Oct 30, 1992~Yes~RX~HOSPIRA INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~HOSPIRA~5MG/ML~N~019916~0
02~~Oct 27, 2006~Yes~RX~HOSPIRA INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~HOSPIRA INC~2MG/ML~N~2025
15~001~~Nov 14, 2011~Yes~RX~HOSPIRA INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~MALLINCKRODT~1MG/ML~N~020
631~001~~Jul 3, 1996~No~DISCN~MALLINCKRODT CHEMICAL INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~MALLINCKRODT~2MG/ML~N~020
631~002~~Jul 3, 1996~No~DISCN~MALLINCKRODT CHEMICAL INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~MERIDIAN MEDCL TECHN~15MG

/ML~N~019999~001~~Jul 12, 1990~Yes~RX~MERIDIAN MEDICAL TECHNOLOGIES INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~WATSON LABS~0.5MG/ML~A~07
3373~001~~Sep 30, 1991~No~DISCN~WATSON LABORATORIES INC
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~WATSON LABS~0.5MG/ML~A~07
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~WATSON LABS~1MG/ML~A~0733
MORPHINE SULFATE~INJECTABLE;INJECTION~MORPHINE SULFATE~WATSON LABS~1MG/ML~A~0733
MOXALACTAM DISODIUM~INJECTABLE;INJECTION~MOXAM~LILLY~EQ 1GM BASE/VIAL~N~050550~0
MOXALACTAM DISODIUM~INJECTABLE;INJECTION~MOXAM~LILLY~EQ 2GM BASE/VIAL~N~050550~0
MOXALACTAM DISODIUM~INJECTABLE;INJECTION~MOXAM~LILLY~EQ 10GM BASE/VIAL~N~050550~
MOXALACTAM DISODIUM~INJECTABLE;INJECTION~MOXAM~LILLY~EQ 250MG BASE/VIAL~N~050550
MOXALACTAM DISODIUM~INJECTABLE;INJECTION~MOXAM~LILLY~EQ 500MG BASE/VIAL~N~050550
TECHNETIUM TC-99M SUCCIMER KIT~INJECTABLE;INJECTION~MPI DMSA KIDNEY REAGENT~GE H
EALTHCARE~N/A~N~017944~001~~May 18, 1982~No~RX~GE HEALTHCARE
TECHNETIUM TC-99M PENTETATE KIT~INJECTABLE;INJECTION~MPI DTPA KIT - CHELATE~GE H
EALTHCARE~N/A~N~017255~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
TECHNETIUM TC-99M ETIDRONATE KIT~INJECTABLE;INJECTION~MPI STANNOUS DIPHOSPHONATE
~GE HEALTHCARE~N/A~N~017667~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALT
HCARE
MECHLORETHAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~MUSTARGEN~RECORDATI RARE~10MG
/VIAL~N~006695~001~~Approved Prior to Jan 1, 1982~Yes~RX~RECORDATI RARE DISEASES
INC
MITOMYCIN~INJECTABLE;INJECTION~MUTAMYCIN~BRISTOL~5MG/VIAL~N~050450~001~~Approved
Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
MITOMYCIN~INJECTABLE;INJECTION~MUTAMYCIN~BRISTOL~20MG/VIAL~N~050450~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
MITOMYCIN~INJECTABLE;INJECTION~MUTAMYCIN~BRISTOL MYERS~5MG/VIAL~A~062336~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS CO
MITOMYCIN~INJECTABLE;INJECTION~MUTAMYCIN~BRISTOL MYERS~20MG/VIAL~A~062336~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS CO
MITOMYCIN~INJECTABLE;INJECTION~MUTAMYCIN~BRISTOL MYERS~40MG/VIAL~A~062336~003~~M
ar 10, 1988~No~DISCN~BRISTOL MYERS CO
HYDROCHLORIDE; VITAMIN A; VITAMIN E~INJECTABLE;INJECTION~MVC PLUS~WATSON LABS~1
0MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/M
L;0.3MG/ML;330 UNITS/ML;1 IU/ML~N~018439~002~~Aug 8, 1985~No~DISCN~WATSON LABORA
TORIES INC
CHLORAMPHENICOL SODIUM SUCCINATE~INJECTABLE;INJECTION~MYCHEL-S~ANGUS~EQ 1GM BASE
/VIAL~A~060132~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANGUS CHEMICAL CO
HEXAFLUORENIUM BROMIDE~INJECTABLE;INJECTION~MYLAXEN~MEDPOINTE PHARM HLC~20MG/ML~
N~009789~003~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS M
EDPOINTE HEALTHCARE INC
GEMTUZUMAB OZOGAMICIN~INJECTABLE;INJECTION~MYLOTARG~WYETH PHARMS INC~5MG/VIAL~N~
021174~001~~May 17, 2000~No~DISCN~WYETH PHARMACEUTICALS INC
TECHNETIUM TC-99M TETROFOSMIN KIT~INJECTABLE;INJECTION~MYOVIEW~GE HEALTHCARE~N/A
~N~020372~001~~Feb 9, 1996~Yes~RX~GE HEALTHCARE
TECHNETIUM TC-99M TETROFOSMIN KIT~INJECTABLE;INJECTION~MYOVIEW 30ML~GE HEALTHCAR
E~N/A~N~020372~002~~Jul 7, 2005~Yes~RX~GE HEALTHCARE
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~AGILA SPECLTS~EQ 1GM BASE
/VIAL~A~200002~001~AP~Apr 7, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~AGILA SPECLTS~EQ 2GM BASE
/VIAL~A~200002~002~AP~Apr 7, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD

NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~ANTIBIOTICE~EQ 1GM BASE/V
IAL~A~090560~001~AP~Oct 3, 2011~No~RX~ANTIBIOTICE SA
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~ANTIBIOTICE~EQ 2GM BASE/V
IAL~A~090560~002~AP~Oct 3, 2011~No~RX~ANTIBIOTICE SA
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~APOTHECON~EQ 1GM BASE/VIA
L~A~061984~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL
MYERS SQUIBB
MYERS SQUIBB
MYERS SQUIBB
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~APOTHECON~EQ 500MG BASE/V
IAL~A~061984~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRIST
OL MYERS SQUIBB
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~AUROBINDO PHARMA LTD~EQ 1
GM BASE/VIAL~A~091613~001~AP~Dec 26, 2012~No~RX~AUROBINDO PHARMA LTD
GM BASE/VIAL~A~091613~002~AP~Dec 26, 2012~No~RX~AUROBINDO PHARMA LTD
0GM BASE/VIAL~A~091614~001~AP~Dec 26, 2012~No~RX~AUROBINDO PHARMA LTD
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~ISTITUTO BIO ITA SPA~EQ 1
GM BASE/VIAL~A~090002~001~AP~Jun 30, 2011~No~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
GM BASE/VIAL~A~090002~002~AP~Jun 30, 2011~No~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
0GM BASE/VIAL~A~090005~001~AP~Apr 20, 2011~No~RX~ISTITUTO BIOCHIMICO ITALIANO SP
A
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~SAGENT PHARMS~EQ 1GM BASE
/VIAL~A~090582~001~AP~Aug 24, 2012~No~RX~SAGENT PHARMACEUTICALS INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~SAGENT PHARMS~EQ 2GM BASE
/VIAL~A~090582~002~AP~Aug 24, 2012~No~RX~SAGENT PHARMACEUTICALS INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~SAGENT PHARMS~EQ 10GM BAS
E/VIAL~A~090580~001~AP~Aug 24, 2012~No~RX~SAGENT PHARMACEUTICALS INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~SANDOZ~EQ 1GM BASE/VIAL~A
~062527~002~AP~Aug 2, 1984~Yes~RX~SANDOZ INC
~062732~001~AP~Dec 23, 1986~Yes~RX~SANDOZ INC
~062527~003~AP~Aug 2, 1984~Yes~RX~SANDOZ INC
~062732~002~AP~Dec 23, 1986~Yes~RX~SANDOZ INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~SANDOZ~EQ 10GM BASE/VIAL~
A~062527~004~AP~Aug 2, 1984~Yes~RX~SANDOZ INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~SANDOZ~EQ 500MG BASE/VIAL
~A~062527~001~~Aug 2, 1984~No~DISCN~SANDOZ INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~WATSON LABS INC~EQ 1GM BA
SE/VIAL~A~062844~002~~Oct 26, 1988~No~DISCN~WATSON LABORATORIES INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~WATSON LABS INC~EQ 1.5GM
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~WATSON LABS INC~EQ 10GM B
ASE/VIAL~A~063008~001~~Sep 29, 1988~No~DISCN~WATSON LABORATORIES INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NAFCILLIN SODIUM~WATSON LABS INC~EQ 500MG
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NALBUPHINE~ABRAXIS PHARM~10MG/ML~A

~070751~001~~Jul 2, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NALBUPHINE~ABRAXIS PHARM~20MG/ML~A
~070752~001~~Sep 24, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NALBUPHINE HYDROCHLORIDE~ABBOTT~20
MG/ML~A~070917~001~~Feb 3, 1989~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NALBUPHINE HYDROCHLORIDE~ABBVIE~1.
5MG/ML~N~020200~001~~Mar 12, 1993~No~DISCN~ABBVIE INC
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NALBUPHINE HYDROCHLORIDE~ASTRAZENE
CA~10MG/ML~A~072070~001~~Apr 10, 1989~No~DISCN~ASTRAZENECA LP
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NALBUPHINE HYDROCHLORIDE~BARR~10MG
/ML~A~074471~001~~Mar 19, 1998~No~DISCN~BARR LABORATORIES INC
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NALBUPHINE HYDROCHLORIDE~BARR~20MG
/ML~A~074471~002~~Mar 19, 1998~No~DISCN~BARR LABORATORIES INC
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NALBUPHINE HYDROCHLORIDE~HOSPIRA~1
0MG/ML~A~070914~001~AP~Feb 3, 1989~Yes~RX~HOSPIRA INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NALLPEN~GLAXOSMITHKLINE~EQ 1GM BASE/VIAL~A
~062755~001~~Dec 19, 1986~No~DISCN~GLAXOSMITHKLINE
~062755~002~~Dec 19, 1986~No~DISCN~GLAXOSMITHKLINE
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NALLPEN~GLAXOSMITHKLINE~EQ 10GM BASE/VIAL~
A~061999~004~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NALLPEN~GLAXOSMITHKLINE~EQ 500MG BASE/VIAL
~A~061999~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NALLPEN IN PLASTIC CONTAINER~BAXTER HLTHCA
RE~EQ 2GM BASE/100ML~N~050655~002~~Oct 31, 1989~Yes~RX~BAXTER HEALTHCARE CORP
NAFCILLIN SODIUM~INJECTABLE;INJECTION~NALLPEN IN PLASTIC CONTAINER~BAXTER HLTHCA
RE~EQ 20MG BASE/ML~N~050655~001~~Oct 31, 1989~Yes~RX~BAXTER HEALTHCARE CORP
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE~HIKMA MAPLE ~0.4MG/ML~A~070
298~001~~Sep 24, 1986~No~DISCN~HIKMA MAPLE LTD
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE~WYETH AYERST~0.02MG/ML~A~07
0188~001~~Sep 24, 1986~No~DISCN~WYETH AYERST LABORATORIES

NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~ABRAXIS PHARM
~0.02MG/ML~A~070648~001~~Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
~1MG/ML~A~071604~001~~Dec 16, 1988~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~ASTRAZENECA~0
.02MG/ML~A~072081~001~~Apr 11, 1989~No~DISCN~ASTRAZENECA LP
MG/ML~A~072091~001~~Apr 11, 1989~No~DISCN~ASTRAZENECA LP
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~HIKMA MAPLE ~
0.02MG/ML~A~071272~001~~May 24, 1988~No~DISCN~HIKMA MAPLE LTD
1MG/ML~A~071273~001~~May 24, 1988~No~DISCN~HIKMA MAPLE LTD
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~HOSPIRA~0.02M
G/ML~A~070171~001~~Sep 24, 1986~No~DISCN~HOSPIRA INC
G/ML~A~070252~001~~Jan 16, 1987~No~DISCN~HOSPIRA INC
G/ML~A~070253~001~~Jan 16, 1987~No~DISCN~HOSPIRA INC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~HOSPIRA~0.4MG
/ML~A~070172~001~AP~Sep 24, 1986~Yes~RX~HOSPIRA INC
/ML~A~070254~001~AP~Jan 7, 1987~Yes~RX~HOSPIRA INC
/ML~A~070255~001~~Jan 7, 1987~No~DISCN~HOSPIRA INC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~INTL MEDICATI

ON~0.4MG/ML~A~070417~001~~Sep 24, 1986~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS
LTD
ON~0.4MG/ML~A~070639~001~AP~Sep 24, 1986~No~RX~INTERNATIONAL MEDICATION SYSTEM
ON~1MG/ML~A~072076~001~AP~Mar 24, 1988~Yes~RX~INTERNATIONAL MEDICATION SYSTEM
ON~1MG/ML~A~072115~001~~Apr 27, 1988~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS L
TD
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~MARSAM PHARMS
LLC~0.4MG/ML~A~071811~001~~Jul 19, 1988~No~DISCN~MARSAM PHARMACEUTICALS LLC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~MYLAN INSTITU
TIONAL~0.4MG/ML~A~204997~001~AP~Mar 6, 2014~No~RX~MYLAN INSTITUTIONAL LLC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~SMITH AND NEP
HEW~0.02MG/ML~A~071671~001~~Nov 17, 1987~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV S
MITH AND NEPHEW
HEW~0.4MG/ML~A~071681~001~~Nov 17, 1987~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SM
ITH AND NEPHEW
HEW~0.4MG/ML~A~071682~001~~Nov 17, 1987~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SM
ITH AND NEPHEW
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~SOLOPAK~0.02M
G/ML~A~071672~001~~Nov 17, 1987~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~SOLOPAK~0.4MG
/ML~A~071683~001~~Nov 17, 1987~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NALOXONE HYDROCHLORIDE~WATSON LABS~0
.4MG/ML~A~071339~001~~Nov 18, 1987~No~DISCN~WATSON LABORATORIES INC
NANDROLONE DECANOATE~INJECTABLE;INJECTION~NANDROLONE DECANOATE~ABRAXIS PHARM~100
MG/ML~A~088290~001~~Oct 3, 1983~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
NANDROLONE DECANOATE~INJECTABLE;INJECTION~NANDROLONE DECANOATE~ABRAXIS PHARM~200
MG/ML~A~088317~001~~Oct 14, 1983~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
NANDROLONE DECANOATE~INJECTABLE;INJECTION~NANDROLONE DECANOATE~AKORN~100MG/ML~A~
087519~001~~Sep 28, 1983~No~DISCN~AKORN INC
NANDROLONE DECANOATE~INJECTABLE;INJECTION~NANDROLONE DECANOATE~PHARMAFORCE~200MG
/ML~A~091252~001~~Aug 30, 2010~Yes~RX~PHARMAFORCE INC
NANDROLONE DECANOATE~INJECTABLE;INJECTION~NANDROLONE DECANOATE~WATSON LABS~50MG/
ML~A~086385~001~~Jan 13, 1984~No~DISCN~WATSON LABORATORIES INC
ML~A~087598~001~~Oct 6, 1983~No~DISCN~WATSON LABORATORIES INC
ML~A~088554~001~~Feb 10, 1986~No~DISCN~WATSON LABORATORIES INC
NANDROLONE DECANOATE~INJECTABLE;INJECTION~NANDROLONE DECANOATE~WATSON LABS~100MG
/ML~A~086598~001~~Jan 13, 1984~No~DISCN~WATSON LABORATORIES INC
/ML~A~087599~001~~Oct 6, 1983~No~DISCN~WATSON LABORATORIES INC
/ML~A~088128~001~~Dec 5, 1983~No~DISCN~WATSON LABORATORIES INC
NANDROLONE PHENPROPIONATE~INJECTABLE;INJECTION~NANDROLONE PHENPROPIONATE~WATSON
LABS~25MG/ML~A~086386~001~~Jun 17, 1983~No~DISCN~WATSON LABORATORIES INC
NANDROLONE PHENPROPIONATE~INJECTABLE;INJECTION~NANDROLONE PHENPROPIONATE~WATSON
LABS~50MG/ML~A~087488~001~~Jun 17, 1983~No~DISCN~WATSON LABORATORIES INC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NARCAN~BRISTOL MYERS SQUIBB~0.4MG/ML
~A~071083~001~~Jul 28, 1988~No~DISCN~BRISTOL MYERS SQUIBB PHARMA CO
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NARCAN~BRISTOL MYERS SQUIBB~1MG/ML~A
~071084~001~~Jul 28, 1988~No~DISCN~BRISTOL MYERS SQUIBB PHARMA CO
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NARCAN~BRISTOL MYERS SQUIBB~1MG/ML~A
~071311~001~~Jul 28, 1988~No~DISCN~BRISTOL MYERS SQUIBB PHARMA CO
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NARCAN~ENDO PHARMS~0.02MG/ML **Feder
al Register determination that product was not discontinued or withdrawn for saf
ety or efficacy reasons**~N~016636~002~~Approved Prior to Jan 1, 1982~No~DISCN~E
NDO PHARMACEUTICALS INC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NARCAN~ENDO PHARMS~0.4MG/ML **Federa
ty or efficacy reasons**~N~016636~001~~Approved Prior to Jan 1, 1982~No~DISCN~EN
DO PHARMACEUTICALS INC
NALOXONE HYDROCHLORIDE~INJECTABLE;INJECTION~NARCAN~ENDO PHARMS~1MG/ML **Federal
Register determination that product was not discontinued or withdrawn for safety
or efficacy reasons**~N~016636~003~~Jun 14, 1982~No~DISCN~ENDO PHARMACEUTICALS
INC
ROPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NAROPIN~FRESENIUS KABI USA~2MG/ML
~N~020533~001~AP~Sep 24, 1996~No~RX~FRESENIUS KABI USA LLC
ROPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NAROPIN~FRESENIUS KABI USA~5MG/ML
~N~020533~003~AP~Sep 24, 1996~No~RX~FRESENIUS KABI USA LLC
ROPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NAROPIN~FRESENIUS KABI USA~7.5MG/
ML~N~020533~004~AP~Sep 24, 1996~No~RX~FRESENIUS KABI USA LLC
ROPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NAROPIN~FRESENIUS KABI USA~10MG/M
L~N~020533~005~AP~Sep 24, 1996~Yes~RX~FRESENIUS KABI USA LLC
ESTRONE~INJECTABLE;INJECTION~NATURAL ESTROGENIC SUBSTANCE-ESTRONE~WATSON LABS~2M
G/ML~A~085237~001~~Nov 23, 1982~No~DISCN~WATSON LABORATORIES INC
THIOTHIXENE HYDROCHLORIDE~INJECTABLE;INJECTION~NAVANE~PFIZER~EQ 2MG BASE/ML~N~01
6904~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER INC
THIOTHIXENE HYDROCHLORIDE~INJECTABLE;INJECTION~NAVANE~PFIZER~EQ 10MG BASE/VIAL~N
~016904~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER INC
VINORELBINE TARTRATE~INJECTABLE;INJECTION~NAVELBINE~PIERRE FABRE~EQ 10MG BASE/ML
~N~020388~001~AP~Dec 23, 1994~Yes~RX~PIERRE FABRE MEDICAMENT
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~NEBCIN~LILLY~EQ 1.2GM BASE/VIAL~N~050519
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~NEBCIN~LILLY~EQ 10MG BASE/ML~A~062008~00
1~~Apr 29, 1987~No~DISCN~ELI LILLY AND CO
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~NEBCIN~LILLY~EQ 10MG BASE/ML~N~050477~00
PENTOBARBITAL SODIUM~INJECTABLE;INJECTION~NEMBUTAL SODIUM~OAK PHARMS~50MG/ML~A~0
83246~001~~Approved Prior to Jan 1, 1982~Yes~RX~OAK PHARMACEUTICALS INC
TECHNETIUM TC-99M DEPREOTIDE~INJECTABLE;INJECTION~NEO TECT KIT~CIS BIO INTL SA~N
/A~N~021012~001~~Aug 3, 1999~No~DISCN~CIS BIO INTERNATIONAL SA
AMINO ACIDS~INJECTABLE;INJECTION~NEOPHAM 6.4%~HOSPIRA~6.4% (6.4GM/100ML)~N~01879
2~001~~Jan 17, 1984~No~DISCN~HOSPIRA INC
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~NEOSAR~BEDFORD~1GM/VIAL~A~087442~004~~Jul
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~NEOSAR~BEDFORD~2GM/VIAL~A~087442~005~~Mar
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~NEOSAR~BEDFORD~100MG/VIAL~A~087442~001~~Fe
b 16, 1982~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~NEOSAR~TEVA PARENTERAL~1GM/VIAL~A~040015~0
04~~Apr 29, 1993~No~DISCN~TEVA PARENTERAL MEDICINES INC
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~NEOSAR~TEVA PARENTERAL~2GM/VIAL~A~040015~0
05~~Apr 29, 1993~No~DISCN~TEVA PARENTERAL MEDICINES INC
CYCLOPHOSPHAMIDE~INJECTABLE;INJECTION~NEOSAR~TEVA PARENTERAL~100MG/VIAL~A~040015
~001~~Apr 29, 1993~No~DISCN~TEVA PARENTERAL MEDICINES INC

GALLIUM CITRATE GA-67~INJECTABLE;INJECTION~NEOSCAN~GE HEALTHCARE~2mCi/ML~N~01765
DYPHYLLINE~INJECTABLE;INJECTION~NEOTHYLLINE~TEVA~250MG/ML~N~009088~001~~Approved
AMINO ACIDS~INJECTABLE;INJECTION~NEPHRAMINE 5.4%~B BRAUN~5.4% (5.4GM/100ML)~N~01
IODOHIPPURATE SODIUM I-123~INJECTABLE;INJECTION~NEPHROFLOW~GE HEALTHCARE~1mCi/ML
~N~018289~001~~Dec 28, 1984~No~DISCN~GE HEALTHCARE
CHLOROPROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NESACAINE~FRESENIUS KABI USA~1
%~N~009435~001~~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
CHLOROPROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NESACAINE~FRESENIUS KABI USA~2
%~N~009435~002~AP~Approved Prior to Jan 1, 1982~No~RX~FRESENIUS KABI USA LLC
CHLOROPROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NESACAINE-MPF~FRESENIUS KABI U
SA~2%~N~009435~003~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS KABI USA LL
C
SA~2%~N~009435~006~AP~May 2, 1996~Yes~RX~FRESENIUS KABI USA LLC
SA~3%~N~009435~004~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS KABI USA LL
C
SA~3%~N~009435~007~AP~May 2, 1996~Yes~RX~FRESENIUS KABI USA LLC
NETILMICIN SULFATE~INJECTABLE;INJECTION~NETROMYCIN~SCHERING~EQ 10MG BASE/ML~N~05
0544~001~~Feb 28, 1983~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
TECHNETIUM TC-99M BICISATE KIT~INJECTABLE;INJECTION~NEUROLITE~LANTHEUS MEDCL~N/A
~N~020256~001~~Nov 23, 1994~No~RX~LANTHEUS MEDICAL IMAGING INC
TRIMETREXATE GLUCURONATE~INJECTABLE;INJECTION~NEUTREXIN~MEDIMMUNE ONCOLOGY~EQ 25
MG BASE/VIAL~N~020326~001~~Dec 17, 1993~No~DISCN~MEDIMMUNE ONCOLOGY INC
TRIMETREXATE GLUCURONATE~INJECTABLE;INJECTION~NEUTREXIN~MEDIMMUNE ONCOLOGY~EQ 20
0MG BASE/VIAL~N~020326~002~~Jul 31, 1998~No~DISCN~MEDIMMUNE ONCOLOGY INC
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~NEXTERONE~BAXTER HLTHCARE~50MG/ML~
N~022325~001~AP~Dec 24, 2008~No~RX~BAXTER HEALTHCARE CORP
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~NEXTERONE~BAXTER HLTHCARE~150MG/10
0ML (1.5MG/ML)~N~022325~002~~Nov 16, 2010~Yes~RX~BAXTER HEALTHCARE CORP
AMIODARONE HYDROCHLORIDE~INJECTABLE;INJECTION~NEXTERONE~BAXTER HLTHCARE~360MG/20
0ML (1.8MG/ML)~N~022325~003~~Nov 16, 2010~Yes~RX~BAXTER HEALTHCARE CORP
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INJECTION~NICARDIPINE HYDROCHLORIDE~BEDFORD
~25MG/10ML (2.5MG/ML)~A~078714~001~AP~Dec 28, 2009~No~RX~BEDFORD LABORATORIES DI
V BEN VENUE LABORATORIES INC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INJECTION~NICARDIPINE HYDROCHLORIDE~EXELA P
HARMA SCIENCE~25MG/10ML (2.5MG/ML)~N~022276~001~AP~Jul 24, 2008~No~RX~EXELA PHAR
MA SCIENCES
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INJECTION~NICARDIPINE HYDROCHLORIDE~LUITPOL
D~25MG/10ML (2.5MG/ML)~A~090534~001~AP~Nov 17, 2009~No~RX~LUITPOLD PHARMACEUTICA
LS INC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INJECTION~NICARDIPINE HYDROCHLORIDE~MYLAN I
NSTITUTIONAL~25MG/10ML (2.5MG/ML)~A~090664~001~AP~Nov 17, 2009~No~RX~MYLAN INSTI
TUTIONAL LLC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INJECTION~NICARDIPINE HYDROCHLORIDE~NAVINTA
LLC~25MG/10ML (2.5MG/ML)~A~090125~001~AP~Nov 17, 2009~No~RX~NAVINTA LLC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INJECTION~NICARDIPINE HYDROCHLORIDE~SUN PHA
RMA GLOBAL~25MG/10ML (2.5MG/ML)~N~078405~001~AP~Nov 17, 2009~No~RX~SUN PHARMA GL
OBAL FZE
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INJECTION~NICARDIPINE HYDROCHLORIDE~WOCKHAR

DT~25MG/10ML (2.5MG/ML)~A~090671~001~AP~Nov 17, 2009~No~RX~WOCKHARDT LTD
CISATRACURIUM BESYLATE~INJECTABLE;INJECTION~NIMBEX~ABBVIE~EQ 2MG BASE/ML~N~02055
1~001~AP~Dec 15, 1995~Yes~RX~ABBVIE INC
CISATRACURIUM BESYLATE~INJECTABLE;INJECTION~NIMBEX PRESERVATIVE FREE~ABBVIE~EQ 2
MG BASE/ML~N~020551~003~AP~Dec 15, 1995~Yes~RX~ABBVIE INC
CISATRACURIUM BESYLATE~INJECTABLE;INJECTION~NIMBEX PRESERVATIVE FREE~ABBVIE~EQ 1
0MG BASE/ML~N~020551~002~AP~Dec 15, 1995~Yes~RX~ABBVIE INC
PENTOSTATIN~INJECTABLE;INJECTION~NIPENT~HOSPIRA INC~10MG/VIAL~N~020122~001~AP~Oc
t 11, 1991~Yes~RX~HOSPIRA INC
SODIUM NITROPRUSSIDE~INJECTABLE;INJECTION~NIPRIDE~ROCHE~50MG/VIAL~N~017546~001~~
NITROGLYCERIN~INJECTABLE;INJECTION~NITRO IV~POHL BOSKAMP~5MG/ML~N~018672~002~~Au
g 30, 1983~No~DISCN~G POHL BOSKAMP GMBH AND CO
NITROGLYCERIN~INJECTABLE;INJECTION~NITRO-BID~SANOFI AVENTIS US~5MG/ML~N~018621~0
01~~Jan 5, 1982~No~DISCN~SANOFI AVENTIS US LLC
NITROGLYCERIN~INJECTABLE;INJECTION~NITRO-BID~SANOFI AVENTIS US~10MG/ML~A~071159~
001~~Feb 28, 1990~No~DISCN~SANOFI AVENTIS US LLC
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN~ABRAXIS PHARM~5MG/ML~A~070077~0
01~~Dec 13, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN~ABRAXIS PHARM~5MG/ML~A~071203~0
01~~May 8, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN~HOSPIRA~5MG/ML~N~018531~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN~INTL MEDICATION~5MG/ML~A~070026
~001~~Sep 10, 1985~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN~LUITPOLD~5MG/ML~A~071492~001~~M
ay 24, 1988~No~DISCN~LUITPOLD PHARMACEUTICALS INC
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN~LUITPOLD~5MG/ML~A~072034~001~~M
ay 24, 1988~Yes~RX~LUITPOLD PHARMACEUTICALS INC
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN~SMITH AND NEPHEW~5MG/ML~A~07063
3~001~~Jun 19, 1986~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN~SMITH AND NEPHEW~5MG/ML~A~07063
4~001~~Jun 19, 1986~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN IN DEXTROSE 5%~BAXTER HLTHCARE~
10MG/100ML~N~019970~001~AP~Dec 29, 1989~Yes~RX~BAXTER HEALTHCARE CORP
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN IN DEXTROSE 5%~HOSPIRA~0.1MG/ML
~A~074083~001~~Oct 26, 1994~No~DISCN~HOSPIRA INC
NITROGLYCERIN~INJECTABLE;INJECTION~NITROGLYCERIN IN DEXTROSE 5%~HOSPIRA~10MG/100
NITROGLYCERIN~INJECTABLE;INJECTION~NITROL~RORER~0.8MG/ML~N~018774~001~~Jan 19, 1
983~No~DISCN~RORER PHARMACEUTICAL CORP SUB RORER GROUP
NITROGLYCERIN~INJECTABLE;INJECTION~NITRONAL~POHL BOSKAMP~1MG/ML~N~018672~001~~Au
g 30, 1983~No~DISCN~G POHL BOSKAMP GMBH AND CO
SODIUM NITROPRUSSIDE~INJECTABLE;INJECTION~NITROPRESS~ABBOTT~50MG/VIAL~A~071555~0
01~~Nov 16, 1987~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
SODIUM NITROPRUSSIDE~INJECTABLE;INJECTION~NITROPRESS~ABBVIE~50MG/VIAL~N~018450~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~ABBVIE INC
SODIUM NITROPRUSSIDE~INJECTABLE;INJECTION~NITROPRESS~HOSPIRA~25MG/ML~A~071961~00
1~~Aug 1, 1988~Yes~RX~HOSPIRA WORLDWIDE, INC
SODIUM NITROPRUSSIDE~INJECTABLE;INJECTION~NITROPRESS~HOSPIRA~50MG/VIAL~A~070566~
001~~Jun 9, 1986~No~DISCN~HOSPIRA INC
NITROGLYCERIN~INJECTABLE;INJECTION~NITROSTAT~PARKE DAVIS~0.8MG/ML~N~018588~001~~
Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
NITROGLYCERIN~INJECTABLE;INJECTION~NITROSTAT~PARKE DAVIS~5MG/ML~A~070863~001~~Ja
NITROGLYCERIN~INJECTABLE;INJECTION~NITROSTAT~PARKE DAVIS~5MG/ML~N~018588~002~~De
c 23, 1983~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
NITROGLYCERIN~INJECTABLE;INJECTION~NITROSTAT~PARKE DAVIS~10MG/ML~A~070871~001~~J
NITROGLYCERIN~INJECTABLE;INJECTION~NITROSTAT~PARKE DAVIS~10MG/ML~A~070872~001~~J
VECURONIUM BROMIDE~INJECTABLE;INJECTION~NORCURON~ORGANON USA INC~10MG/VIAL~N~018
776~002~~Apr 30, 1984~No~DISCN~ORGANON USA INC
VECURONIUM BROMIDE~INJECTABLE;INJECTION~NORCURON~ORGANON USA INC~20MG/VIAL~N~018
776~003~~Jan 3, 1992~No~DISCN~ORGANON USA INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NORDITROPIN~NOVO NORDISK INC~4MG/VIA
L~N~019721~001~~May 8, 1995~No~DISCN~NOVO NORDISK INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NORDITROPIN~NOVO NORDISK INC~5MG/1.5
ML~N~021148~001~~Jun 20, 2000~No~DISCN~NOVO NORDISK INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NORDITROPIN~NOVO NORDISK INC~8MG/VIA
L~N~019721~002~~May 8, 1995~No~DISCN~NOVO NORDISK INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NORDITROPIN~NOVO NORDISK INC~10MG/1.
5ML~N~021148~002~~Jun 20, 2000~No~DISCN~NOVO NORDISK INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NORDITROPIN~NOVO NORDISK INC~15MG/1.
5ML~N~021148~003~~Jun 20, 2000~No~DISCN~NOVO NORDISK INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NORDITROPIN FLEXPRO~NOVO NORDISK INC
~5MG/1.5ML~N~021148~008~BX~Mar 1, 2010~No~RX~NOVO NORDISK INC
~10MG/1.5ML~N~021148~009~BX~Mar 1, 2010~No~RX~NOVO NORDISK INC
~15MG/1.5ML~N~021148~010~~Mar 1, 2010~No~RX~NOVO NORDISK INC
~30MG/3ML~N~021148~011~~Jan 23, 2015~No~RX~NOVO NORDISK INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NORDITROPIN NORDIFLEX~NOVO NORDISK I
NC~5MG/1.5ML~N~021148~004~~Oct 1, 2004~No~DISCN~NOVO NORDISK INC
NC~30MG/3ML~N~021148~007~~Mar 10, 2009~No~DISCN~NOVO NORDISK INC
NOREPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~NOREPINEPHRINE BITARTRATE~BEDFORD
~EQ 1MG BASE/ML~A~040462~001~AP~Oct 31, 2003~No~RX~BEDFORD LABORATORIES DIV BEN
NOREPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~NOREPINEPHRINE BITARTRATE~CLARIS
LIFESCIENCES~EQ 1MG BASE/ML~A~040859~001~AP~Mar 27, 2012~No~RX~CLARIS LIFESCIENC
ES LTD
NOREPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~NOREPINEPHRINE BITARTRATE~METRICS
PHARM~EQ 1MG BASE/ML~A~040522~001~~Sep 30, 2004~No~DISCN~METRICS PHARMACEUTICAL
VENTURES LLC
NOREPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~NOREPINEPHRINE BITARTRATE~TEVA PH
ARMS USA~EQ 1MG BASE/ML~A~040455~001~AP~Mar 3, 2003~No~RX~TEVA PHARMACEUTICALS U
SA
ORPHENADRINE CITRATE~INJECTABLE;INJECTION~NORFLEX~MEDICIS~30MG/ML~N~013055~001~A
P~Approved Prior to Jan 1, 1982~Yes~RX~MEDICIS PHARMACEUTICAL CORP
ARDEPARIN SODIUM~INJECTABLE;INJECTION~NORMIFLO~PHARMACIA AND UPJOHN~5,000 UNITS/
0.5ML **Federal Register determination that product was not discontinued or with
drawn for safety or efficacy reasons**~N~020227~002~~May 23, 1997~No~DISCN~PHARM
ACIA AND UPJOHN CO
ARDEPARIN SODIUM~INJECTABLE;INJECTION~NORMIFLO~PHARMACIA AND UPJOHN~10,000 UNITS
/0.5ML **Federal Register determination that product was not discontinued or wit
hdrawn for safety or efficacy reasons**~N~020227~001~~May 23, 1997~No~DISCN~PHAR

MACIA AND UPJOHN CO
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~NORMODYNE~SCHERING~5MG/ML~N~018686~
001~~Aug 1, 1984~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE~INJECTABLE;INJEC
TION~NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;21MG/100M
L;128MG/100ML;234MG/100ML~N~017610~001~~Approved Prior to Jan 1, 1982~No~RX~HOSP
IRA INC
E; SODIUM GLUCONATE~INJECTABLE;INJECTION~NORMOSOL-R AND DEXTROSE 5% IN PLASTIC C
ONTAINER~HOSPIRA~5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/1
00ML~N~017609~001~~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
GLUCONATE~INJECTABLE;INJECTION~NORMOSOL-R IN PLASTIC CONTAINER~HOSPIRA~30MG/100M
L;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML~N~017586~001~~Approved Prior to
Jan 1, 1982~No~RX~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~NOVAMINE 11.4%~HOSPIRA INC~11.4% (11.4GM/100ML)
~N~017957~003~~Aug 9, 1982~No~DISCN~HOSPIRA INC
AMINO ACIDS~INJECTABLE;INJECTION~NOVAMINE 15%~HOSPIRA INC~15% (75GM/500ML)~N~017
AMINO ACIDS~INJECTABLE;INJECTION~NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER~
BAXTER HLTHCARE~15% (15GM/100ML)~N~020107~001~~Feb 5, 1993~No~DISCN~BAXTER HEALT
HCARE CORP
AMINO ACIDS~INJECTABLE;INJECTION~NOVAMINE 8.5%~HOSPIRA INC~8.5% (8.5GM/100ML)~N~
017957~002~~Aug 9, 1982~No~DISCN~HOSPIRA INC
MITOXANTRONE HYDROCHLORIDE~INJECTABLE;INJECTION~NOVANTRONE~EMD SERONO~EQ 20MG BA
SE/10ML (EQ 2MG BASE/ML)~N~019297~001~~Dec 23, 1987~No~DISCN~EMD SERONO INC
SE/12.5ML (EQ 2MG BASE/ML)~N~019297~002~~Dec 23, 1987~No~DISCN~EMD SERONO INC
SE/15ML (EQ 2MG BASE/ML)~N~019297~003~~Dec 23, 1987~No~DISCN~EMD SERONO INC
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NOVOCAIN~HOSPIRA~1%~A~085362~003~~Ap
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NOVOCAIN~HOSPIRA~2%~A~085362~004~~Ap
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~NOVOCAIN~HOSPIRA~10%~A~086797~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED
HUMAN~INJECTABLE;INJECTION~NOVOLIN 70/30~NOVO NORDISK INC~30 UNITS/ML;70 UNITS/
ML~N~019441~001~~Jul 11, 1986~No~DISCN~NOVO NORDISK INC
JECTION~NOVOLIN 70/30~NOVO NORDISK INC~30 UNITS/ML;70 UNITS/ML~N~019991~001~~Jun
25, 1991~Yes~OTC~NOVO NORDISK INC
INSULIN ZINC SUSP SEMISYNTHETIC PURIFIED HUMAN~INJECTABLE;INJECTION~NOVOLIN L~NO
VO NORDISK INC~100 UNITS/ML~N~018777~001~~Aug 30, 1983~No~DISCN~NOVO NORDISK INC
INSULIN ZINC SUSP RECOMBINANT HUMAN~INJECTABLE;INJECTION~NOVOLIN L~NOVO NORDISK
INC~100 UNITS/ML~N~019965~001~~Jun 25, 1991~No~DISCN~NOVO NORDISK INC
INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN~INJECTABLE;INJECTION~NOVOLIN
N~NOVO NORDISK INC~100 UNITS/ML~N~019065~001~~Jan 23, 1985~No~DISCN~NOVO NORDISK
INC
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN~INJECTABLE;INJECTION~NOVOLIN N~NOVO NORD
ISK INC~100 UNITS/ML~N~019959~001~~Jul 1, 1991~Yes~OTC~NOVO NORDISK INC
INSULIN RECOMBINANT PURIFIED HUMAN~INJECTABLE;INJECTION~NOVOLIN R~NOVO NORDISK I
NC~100 UNITS/ML~N~018778~001~~Aug 30, 1983~No~DISCN~NOVO NORDISK INC
INSULIN RECOMBINANT HUMAN~INJECTABLE;INJECTION~NOVOLIN R~NOVO NORDISK INC~100 UN
ITS/ML~N~019938~001~~Jun 25, 1991~Yes~OTC~NOVO NORDISK INC
INSULIN SUSP ISOPHANE BEEF/PORK~INJECTABLE;INJECTION~NPH ILETIN I (BEEF-PORK)~LI
LLY~40 UNITS/ML~N~017936~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY A
ND CO
INSULIN SUSP ISOPHANE BEEF/PORK~INJECTABLE;INJECTION~NPH ILETIN I (BEEF-PORK)~LI
LLY~100 UNITS/ML~N~017936~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY

AND CO
INSULIN SUSP ISOPHANE PURIFIED BEEF~INJECTABLE;INJECTION~NPH ILETIN II~LILLY~100
UNITS/ML~N~018479~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
INSULIN SUSP ISOPHANE PURIFIED PORK~INJECTABLE;INJECTION~NPH ILETIN II (PORK)~LI
LLY~100 UNITS/ML~N~018345~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY
AND CO
INSULIN SUSP ISOPHANE BEEF~INJECTABLE;INJECTION~NPH INSULIN~NOVO NORDISK INC~40
INSULIN SUSP ISOPHANE BEEF~INJECTABLE;INJECTION~NPH INSULIN~NOVO NORDISK INC~100
INSULIN SUSP ISOPHANE PURIFIED PORK~INJECTABLE;INJECTION~NPH PURIFIED PORK ISOPH
ANE INSULIN~NOVO NORDISK INC~100 UNITS/ML~N~018623~001~~Approved Prior to Jan 1,
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NUBAIN~ENDO PHARMS~10MG/ML~N~01802
NALBUPHINE HYDROCHLORIDE~INJECTABLE;INJECTION~NUBAIN~ENDO PHARMS~20MG/ML~N~01802
4~002~~May 27, 1982~No~DISCN~ENDO PHARMACEUTICALS INC
DOXACURIUM CHLORIDE~INJECTABLE;INJECTION~NUROMAX~ABBVIE~EQ 1MG BASE/ML~N~019946~
001~~Mar 7, 1991~No~DISCN~ABBVIE INC
SOYBEAN OIL~INJECTABLE;INJECTION~NUTRILIPID 10%~B BRAUN~10%~N~019531~001~AP~May
28, 1993~Yes~RX~B BRAUN MEDICAL INC
SOYBEAN OIL~INJECTABLE;INJECTION~NUTRILIPID 20%~B BRAUN~20%~N~019531~002~AP~May
28, 1993~Yes~RX~B BRAUN MEDICAL INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN~GENENTECH~5MG/VIAL~N~020168
~001~BX~Nov 17, 1993~No~RX~GENENTECH INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN~GENENTECH~10MG/VIAL~N~02016
8~002~~Nov 17, 1993~Yes~RX~GENENTECH INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN AQ~GENENTECH~5MG/2ML (2.5MG
/ML)~N~020522~003~~Jan 3, 2008~Yes~RX~GENENTECH INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN AQ~GENENTECH~10MG/2ML (5MG/
ML)~N~020522~001~~Dec 29, 1995~Yes~RX~GENENTECH INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN AQ~GENENTECH~20MG/2ML (10MG
/ML)~N~020522~004~~Jan 3, 2008~Yes~RX~GENENTECH INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN AQ PEN~GENENTECH~10MG/2ML (
5MG/ML)~N~020522~002~~Apr 22, 2002~Yes~RX~GENENTECH INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN DEPOT~GENENTECH~13.5MG/VIAL
~N~021075~001~~Dec 22, 1999~No~DISCN~GENENTECH INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN DEPOT~GENENTECH~18MG/VIAL~N
~021075~002~~Dec 22, 1999~No~DISCN~GENENTECH INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~NUTROPIN DEPOT~GENENTECH~22.5MG/VIAL
~N~021075~003~~Dec 22, 1999~No~DISCN~GENENTECH INC
ISONIAZID~INJECTABLE;INJECTION~NYDRAZID~SANDOZ~100MG/ML~N~008662~001~~Approved P
rior to Jan 1, 1982~No~DISCN~SANDOZ INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~OCTOCAINE~SEPTODONT~0.
01MG/ML;2%~A~084048~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~SEPTODONT INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~OCTOCAINE~SEPTODONT~0.
02MG/ML;2%~A~084048~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~SEPTODONT INC
INDIUM IN-111 PENTETREOTIDE KIT~INJECTABLE;INJECTION~OCTREOSCAN~MALLINCKRODT~3mC
i/ML~N~020314~001~~Jun 2, 1994~Yes~RX~MALLINCKRODT MEDICAL INC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~EUROHLTH INTL SARL~EQ
0.2MG BASE/ML~A~076330~001~AP~Apr 8, 2005~Yes~RX~EUROHEALTH INTERNATIONAL SARL
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~EUROHLTH INTL SARL~EQ
1MG BASE/ML~A~076330~002~AP~Apr 8, 2005~Yes~RX~EUROHEALTH INTERNATIONAL SARL
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~FRESENIUS KABI USA~EQ
0.2MG BASE/ML~A~077450~001~AP~Feb 10, 2006~No~RX~FRESENIUS KABI USA LLC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~FRESENIUS KABI USA~EQ
1MG BASE/ML~A~077450~002~AP~Feb 10, 2006~No~RX~FRESENIUS KABI USA LLC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~SAGENT PHARMS~EQ 0.2M
G BASE/ML~A~091041~001~AP~Nov 12, 2013~No~RX~SAGENT PHARMACEUTICALS INC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~SAGENT PHARMS~EQ 1MG

BASE/ML~A~091041~002~AP~Nov 12, 2013~No~RX~SAGENT PHARMACEUTICALS INC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~SUN PHARM INDS~EQ 0.0
5MG BASE/ML~A~077329~001~AP~Mar 4, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
5MG BASE/ML~A~077372~001~AP~Aug 14, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
MG BASE/ML~A~077329~002~AP~Mar 4, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
MG BASE/ML~A~077372~002~AP~Aug 14, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~SUN PHARM INDS~EQ 1MG
BASE/ML~A~077331~001~AP~Mar 4, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~SUN PHARM INDS~EQ 1MG
BASE/ML~A~077373~002~AP~Aug 14, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~TEVA PHARMS USA~EQ 0.
05MG BASE/ML~A~075957~001~AP~Oct 3, 2005~No~RX~TEVA PHARMACEUTICALS USA
2MG BASE/ML~A~075959~001~AP~Nov 21, 2005~No~RX~TEVA PHARMACEUTICALS USA
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~TEVA PHARMS USA~EQ 1M
G BASE/ML~A~075959~002~AP~Nov 21, 2005~No~RX~TEVA PHARMACEUTICALS USA
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~WOCKHARDT USA~EQ 0.2M
G BASE/ML~A~090986~001~AP~May 11, 2011~No~RX~WOCKHARDT USA INC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE~WOCKHARDT USA~EQ 1MG
BASE/ML~A~090986~002~AP~May 11, 2011~No~RX~WOCKHARDT USA INC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE (PRESERVATIVE FREE)~E
UROHLTH INTL SARL~EQ 0.05MG BASE/ML~A~076313~001~AP~Mar 28, 2005~Yes~RX~EUROHEAL
TH INTERNATIONAL SARL
UROHLTH INTL SARL~EQ 0.1MG BASE/ML~A~076313~003~AP~Mar 28, 2005~Yes~RX~EUROHEALT
UROHLTH INTL SARL~EQ 0.5MG BASE/ML~A~076313~002~AP~Mar 28, 2005~Yes~RX~EUROHEALT
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE (PRESERVATIVE FREE)~F
RESENIUS KABI USA~EQ 0.05MG BASE/ML~A~077457~001~AP~Feb 10, 2006~No~RX~FRESENIUS
KABI USA LLC
KABI USA LLC
KABI USA LLC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE (PRESERVATIVE FREE)~M
YLAN INSTITUTIONAL~EQ 0.05MG BASE/ML~A~079198~001~AP~Feb 10, 2011~No~RX~MYLAN IN
STITUTIONAL LLC
YLAN INSTITUTIONAL~EQ 0.1MG BASE/ML~A~079198~002~AP~Feb 10, 2011~No~RX~MYLAN INS
TITUTIONAL LLC

YLAN INSTITUTIONAL~EQ 0.5MG BASE/ML~A~079198~003~AP~Feb 10, 2011~No~RX~MYLAN INS
TITUTIONAL LLC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE (PRESERVATIVE FREE)~S
AGENT PHARMS~EQ 0.05MG BASE/ML~A~090834~001~AP~Nov 12, 2013~No~RX~SAGENT PHARMAC
EUTICALS INC
AGENT PHARMS~EQ 0.1MG BASE/ML~A~090834~002~AP~Nov 12, 2013~No~RX~SAGENT PHARMACE
UTICALS INC
AGENT PHARMS~EQ 0.5MG BASE/ML~A~090834~003~AP~Nov 12, 2013~No~RX~SAGENT PHARMACE
UTICALS INC
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~OCTREOTIDE ACETATE (PRESERVATIVE FREE)~W
OCKHARDT USA~EQ 0.05MG BASE/ML~A~090985~001~AP~May 11, 2011~No~RX~WOCKHARDT USA
INC
OCKHARDT USA~EQ 0.1MG BASE/ML~A~090985~002~AP~May 11, 2011~No~RX~WOCKHARDT USA I
NC
OCKHARDT USA~EQ 0.5MG BASE/ML~A~090985~003~AP~May 11, 2011~No~RX~WOCKHARDT USA I
NC
OFLOXACIN~INJECTABLE;INJECTION~OFLOXACIN~BEDFORD~40MG/ML~A~075762~001~~Jan 16, 2
IOHEXOL~INJECTABLE;INJECTION~OMNIPAQUE 140~GE HEALTHCARE~30.2%~N~018956~005~~Nov
30, 1988~Yes~RX~GE HEALTHCARE
IOHEXOL~INJECTABLE;INJECTION~OMNIPAQUE 210~GE HEALTHCARE~45.3%~N~018956~006~~Jun
30, 1989~No~DISCN~GE HEALTHCARE
AMPICILLIN SODIUM~INJECTABLE;INJECTION~OMNIPEN-N~WYETH AYERST~EQ 1GM BASE/VIAL~A
~062718~004~~Dec 16, 1986~No~DISCN~WYETH AYERST LABORATORIES
~062718~005~~Dec 16, 1986~No~DISCN~WYETH AYERST LABORATORIES
AMPICILLIN SODIUM~INJECTABLE;INJECTION~OMNIPEN-N~WYETH AYERST~EQ 125MG BASE/VIAL
~A~060626~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
~A~062718~001~~Dec 16, 1986~No~DISCN~WYETH AYERST LABORATORIES
GADODIAMIDE~INJECTABLE;INJECTION~OMNISCAN~GE HEALTHCARE~14.35GM/50ML (287MG/ML)~
N~022066~001~~Sep 5, 2007~No~DISCN~GE HEALTHCARE
GADODIAMIDE~INJECTABLE;INJECTION~OMNISCAN~GE HEALTHCARE~28.7GM/100ML (287MG/ML)~
N~022066~002~~Sep 5, 2007~Yes~RX~GE HEALTHCARE
GADODIAMIDE~INJECTABLE;INJECTION~OMNISCAN~GE HEALTHCARE~287MG/ML~N~020123~001~~J
an 8, 1993~Yes~RX~GE HEALTHCARE
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~OMNITROPE~SANDOZ~1.5MG/VIAL~N~021426
~002~BX~May 30, 2006~No~RX~SANDOZ INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~OMNITROPE~SANDOZ~5MG/1.5ML~N~021426~
003~BX~Jan 16, 2008~No~RX~SANDOZ INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~OMNITROPE~SANDOZ~5.8MG/VIAL~N~021426
~001~BX~May 30, 2006~No~RX~SANDOZ INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~OMNITROPE~SANDOZ~10MG/1.5ML~N~021426
~004~BX~Aug 25, 2008~No~RX~SANDOZ INC

VINCRISTINE SULFATE~INJECTABLE;INJECTION~ONCOVIN~LILLY~1MG/VIAL~N~014103~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
VINCRISTINE SULFATE~INJECTABLE;INJECTION~ONCOVIN~LILLY~1MG/ML~N~014103~003~~Mar
VINCRISTINE SULFATE~INJECTABLE;INJECTION~ONCOVIN~LILLY~5MG/VIAL~N~014103~002~~Ap
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~AGILA S
PECLTS~EQ 2MG BASE/ML~A~078257~001~AP~Apr 23, 2008~No~RX~AGILA SPECIALTIES PRIVA
TE LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~APOTEX
INC~EQ 2MG BASE/ML~A~077368~001~~Dec 26, 2006~No~DISCN~APOTEX INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~AUROBIN
DO PHARMA LTD~EQ 2MG BASE/ML~A~202599~001~AP~Dec 21, 2012~No~RX~AUROBINDO PHARMA
LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~BEDFORD
~EQ 2MG BASE/ML~A~076967~001~AP~Dec 26, 2006~No~RX~BEDFORD LABORATORIES DIV BEN
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~CLARIS
LIFESCIENCES~EQ 2MG BASE/ML~A~078288~001~AP~Feb 22, 2013~No~RX~CLARIS LIFESCIENC
ES LIMITED
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~EMCURE
PHARMS~EQ 2MG BASE/ML~A~090424~001~AP~Apr 16, 2010~No~RX~EMCURE PHARMACEUTICALS
LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~FRESENI
US KABI USA~EQ 2MG BASE/ML~A~076974~001~AP~Dec 26, 2006~No~RX~FRESENIUS KABI USA
LLC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~GLAND P
HARMA LTD~EQ 2MG BASE/ML~A~079224~001~AP~Sep 25, 2009~No~RX~GLAND PHARMA LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~GLAND P
HARMA LTD~EQ 2MG BASE/ML~A~090648~001~AP~Jun 15, 2012~No~RX~GLAND PHARMA LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~HIKMA F
ARMACEUTICA~EQ 2MG BASE/ML~A~076781~001~AP~Dec 26, 2006~No~RX~HIKMA FARMACEUTICA
(PORTUGAL) SA
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~HIKMA M
APLE ~EQ 2MG BASE/ML~A~077365~001~AP~Dec 26, 2006~No~RX~HIKMA MAPLE LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~HOSPIRA
~EQ 2MG BASE/ML~A~076695~001~~Dec 26, 2006~No~DISCN~HOSPIRA INC
~EQ 2MG BASE/ML~A~077473~001~AP~Dec 26, 2006~No~RX~HOSPIRA INC
~EQ 2MG BASE/ML~A~077840~001~AP~Jan 19, 2007~No~RX~HOSPIRA INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~LANNETT
~EQ 2MG BASE/ML~A~090116~001~~Apr 14, 2010~No~DISCN~LANNETT HOLDINGS INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~LANNETT
~EQ 2MG BASE/ML~A~090883~001~AP~Aug 5, 2010~No~RX~LANNETT HOLDINGS INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~LUITPOL
D~EQ 2MG BASE/ML~A~077582~001~~Dec 26, 2006~No~DISCN~LUITPOLD PHARMACEUTICALS IN
C
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~LUITPOL
D~EQ 2MG BASE/ML~A~079039~001~AP~Nov 18, 2008~No~RX~LUITPOLD PHARMACEUTICALS INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~PLIVA H
RVATSKA DOO~EQ 2MG BASE/ML~A~077544~001~~Dec 26, 2006~No~DISCN~PLIVA HRVATSKA DO
O
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~QILU PH
ARM CO LTD~EQ 2MG BASE/ML~A~203711~001~AP~Sep 8, 2014~No~RX~QILU PHARMACEUTICAL
CO LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~SAGENT
PHARMS~EQ 2MG BASE/ML~A~078180~001~~Mar 26, 2007~No~DISCN~SAGENT PHARMACEUTICALS
INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~SANDOZ~

EQ 2MG BASE/ML~A~077430~001~AP~Jun 27, 2007~No~RX~SANDOZ CANADA INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~SUN PHA
RM INDS (IN)~EQ 2MG BASE/ML~A~077172~001~AP~Dec 26, 2006~No~RX~SUN PHARMACEUTICA
L INDUSTRIES LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~TEVA~EQ
2MG BASE/ML~A~076876~001~AP~Nov 22, 2006~No~RX~TEVA PHARMACEUTICALS USA INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE~WOCKHAR
DT~EQ 2MG BASE/ML~A~077577~001~AP~Dec 26, 2006~No~RX~WOCKHARDT LTD
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE AND DEX
TROSE IN PLASTIC CONTAINER~BEDFORD LABS~EQ 0.64MG BASE/ML~A~078291~001~~Apr 13,
2009~No~DISCN~BEDFORD LABORATORIES
TROSE IN PLASTIC CONTAINER~CLARIS LIFESCIENCES~EQ 0.64MG BASE/ML~A~078308~001~~M
ar 17, 2008~No~DISCN~CLARIS LIFESCIENCES LTD
TROSE IN PLASTIC CONTAINER~HOSPIRA~EQ 0.64MG BASE/ML~A~076978~001~~Feb 26, 2007~
TROSE IN PLASTIC CONTAINER~HOSPIRA~EQ 0.64MG BASE/ML~A~077348~001~~Feb 1, 2007~N
o~DISCN~HOSPIRA INC
TROSE IN PLASTIC CONTAINER~TEVA PHARMS~EQ 0.64MG BASE/ML~A~077480~001~~Nov 22, 2
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE AND SOD
IUM CHLORIDE IN PLASTIC CONTAINER~BAXTER HLTHCARE~EQ 0.64MG BASE/ML~N~021915~002
~~Dec 27, 2006~No~DISCN~BAXTER HEALTHCARE CORP
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ONDANSETRON HYDROCHLORIDE PRESERV
ATIVE FREE~AGILA SPECLTS~EQ 2MG BASE/ML~A~078244~001~AP~Apr 23, 2008~No~RX~AGILA
SPECIALTIES PRIVATE LTD
ATIVE FREE~APOTEX INC~EQ 2MG BASE/ML~A~077343~001~~Dec 26, 2006~No~DISCN~APOTEX
INC
ATIVE FREE~AUROBINDO PHARMA LTD~EQ 2MG BASE/ML~A~202600~001~AP~Dec 21, 2012~No~R
X~AUROBINDO PHARMA LTD
ATIVE FREE~BD RX~EQ 2MG BASE/ML~A~202253~001~AP~Jul 19, 2013~No~RX~BD RX INC
ATIVE FREE~BEDFORD LABS~EQ 2MG BASE/ML~A~077011~001~AP~Dec 26, 2006~No~RX~BEDFOR
D LABORATORIES
ATIVE FREE~CLARIS LIFESCIENCES~EQ 2MG BASE/ML~A~078287~001~AP~Feb 22, 2013~No~RX
~CLARIS LIFESCIENCES LIMITED
ATIVE FREE~EMCURE PHARMS LTD~EQ 2MG BASE/ML~A~078945~001~AP~Jan 3, 2013~No~RX~EM
CURE PHARMACEUTICALS LTD
ATIVE FREE~FRESENIUS KABI USA~EQ 2MG BASE/ML~A~076972~001~AP~Dec 26, 2006~No~RX~
FRESENIUS KABI USA LLC
ATIVE FREE~HIKMA FARMACEUTICA~EQ 2MG BASE/ML~A~076780~001~AP~Dec 26, 2006~No~RX~
HIKMA FARMACEUTICA (PORTUGAL) SA
ATIVE FREE~HIKMA MAPLE ~EQ 2MG BASE/ML~A~077541~001~AP~Dec 26, 2006~No~RX~HIKMA
MAPLE LTD
ATIVE FREE~HOSPIRA~EQ 2MG BASE/ML~A~076696~001~~Dec 26, 2006~No~DISCN~HOSPIRA IN
C
ATIVE FREE~HOSPIRA~EQ 2MG BASE/ML~A~077548~001~AP~Dec 26, 2006~No~RX~HOSPIRA INC

ATIVE FREE~LUITPOLD~EQ 2MG BASE/ML~A~077387~001~~Dec 26, 2006~No~DISCN~LUITPOLD
PHARMACEUTICALS INC
ATIVE FREE~LUITPOLD~EQ 2MG BASE/ML~A~079032~001~AP~Nov 18, 2008~No~RX~LUITPOLD P
HARMACEUTICALS INC
ATIVE FREE~SANDOZ~EQ 2MG BASE/ML~A~077551~001~AP~Jun 27, 2007~No~RX~SANDOZ CANAD
A INC
ATIVE FREE~SUN PHARM INDS LTD~EQ 2MG BASE/ML~A~077173~001~AP~Dec 26, 2006~No~RX~
SUN PHARMACEUTICAL INDUSTRIES LTD
ATIVE FREE~TARO PHARMS IRELAND~EQ 2MG BASE/ML~A~078014~001~~Mar 21, 2008~No~DISC
N~TARO PHARMACEUTICALS IRELAND LTD
ATIVE FREE~TEVA~EQ 2MG BASE/ML~A~076759~001~AP~Nov 22, 2006~No~RX~TEVA PHARMACEU
TICALS USA INC
ATIVE FREE~WOCKHARDT~EQ 2MG BASE/ML~A~077716~001~AP~Dec 26, 2006~No~RX~WOCKHARDT
LTD
OXYMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~OPANA~ENDO PHARMS~1MG/ML~N~011707
~002~~Approved Prior to Jan 1, 1982~Yes~RX~ENDO PHARMACEUTICALS INC
OXYMORPHONE HYDROCHLORIDE~INJECTABLE;INJECTION~OPANA~ENDO PHARMS~1.5MG/ML~N~0117
GADOVERSETAMIDE~INJECTABLE;INJECTION~OPTIMARK~LIEBEL-FLARSHEIM~16.545GM/50ML (33
0.9MG/ML)~N~020975~001~~Dec 8, 1999~Yes~RX~LIEBEL-FLARSHEIM CO LLC
GADOVERSETAMIDE~INJECTABLE;INJECTION~OPTIMARK~LIEBEL-FLARSHEIM~1654.5MG/5ML (330
.9MG/ML)~N~020937~001~~Dec 8, 1999~Yes~RX~LIEBEL-FLARSHEIM CO LLC
GADOVERSETAMIDE~INJECTABLE;INJECTION~OPTIMARK~LIEBEL-FLARSHEIM~3309MG/10ML (330.
9MG/ML)~N~020937~002~~Dec 8, 1999~Yes~RX~LIEBEL-FLARSHEIM CO LLC
GADOVERSETAMIDE~INJECTABLE;INJECTION~OPTIMARK~LIEBEL-FLARSHEIM~4963.5MG/15ML (33
0.9MG/ML)~N~020937~003~~Dec 8, 1999~Yes~RX~LIEBEL-FLARSHEIM CO LLC
GADOVERSETAMIDE~INJECTABLE;INJECTION~OPTIMARK~LIEBEL-FLARSHEIM~6618MG/20ML (330.
9MG/ML)~N~020937~004~~Dec 8, 1999~Yes~RX~LIEBEL-FLARSHEIM CO LLC
GADOVERSETAMIDE~INJECTABLE;INJECTION~OPTIMARK IN PLASTIC CONTAINER~LIEBEL-FLARSH
EIM~3309MG/10ML (330.9MG/ML)~N~020976~002~~Dec 8, 1999~Yes~RX~LIEBEL-FLARSHEIM C
O LLC
EIM~4963.5MG/15ML (330.9MG/ML)~N~020976~003~~Dec 8, 1999~Yes~RX~LIEBEL-FLARSHEIM
CO LLC
O LLC
O LLC
IOVERSOL~INJECTABLE;INJECTION~OPTIRAY 160~LIEBEL-FLARSHEIM~34%~N~019710~003~~Dec
30, 1988~No~DISCN~LIEBEL-FLARSHEIM CO LLC
30, 1988~Yes~RX~LIEBEL-FLARSHEIM CO LLC
IOVERSOL~INJECTABLE;INJECTION~OPTIRAY 240~LIEBEL-FLARSHEIM~51%~N~020923~001~~May
IOVERSOL~INJECTABLE;INJECTION~OPTIRAY 300~LIEBEL-FLARSHEIM~64%~N~019710~004~~Jan
IOVERSOL~INJECTABLE;INJECTION~OPTIRAY 350~LIEBEL-FLARSHEIM~74%~N~019710~005~~Jan
ALBUMIN HUMAN~INJECTABLE;INJECTION~OPTISON~GE HEALTHCARE~10MG/ML~N~020899~001~~D
ec 31, 1997~Yes~RX~GE HEALTHCARE
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~ORABLOC~PIE
RREL~4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)~N~022466~001~~Feb 26, 2010~No
~RX~PIERREL S.P.A.
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~ORABLOC~PIE
RREL~4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)~N~022466~002~~Feb 26, 2010~Yes
~RX~PIERREL S.P.A.
PHENTOLAMINE MESYLATE~INJECTABLE;INJECTION~ORAVERSE~SEPTODONT HOLDING~0.4MG/1.7M
L~N~022159~001~~May 9, 2008~Yes~RX~SEPTODONT HOLDING SAS
DANAPAROID SODIUM~INJECTABLE;INJECTION~ORGARAN~AGI~750 UNITS/0.6ML~N~020430~001~
~Dec 24, 1996~No~DISCN~ASPEN GLOBAL INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~ORGATRAX~ORGANON USA INC~25MG/ML~
A~087014~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~ORGATRAX~ORGANON USA INC~50MG/ML~
A~087014~002~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
TOLBUTAMIDE SODIUM~INJECTABLE;INJECTION~ORINASE DIAGNOSTIC~PHARMACIA AND UPJOHN~
EQ 1GM BASE/VIAL~N~012095~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA
AND UPJOHN CO
EFLORNITHINE HYDROCHLORIDE~INJECTABLE;INJECTION~ORNIDYL~SANOFI AVENTIS US~200MG/
ML~N~019879~002~~Nov 28, 1990~No~DISCN~SANOFI AVENTIS US LLC
ORPHENADRINE CITRATE~INJECTABLE;INJECTION~ORPHENADRINE CITRATE~AKORN~30MG/ML~A~0
40484~001~AP~May 24, 2006~No~RX~AKORN INC
ORPHENADRINE CITRATE~INJECTABLE;INJECTION~ORPHENADRINE CITRATE~EUROHLTH INTL SAR
L~30MG/ML~A~040463~001~AP~Mar 4, 2003~No~RX~EUROHEALTH INTERNATIONAL SARL
ORPHENADRINE CITRATE~INJECTABLE;INJECTION~ORPHENADRINE CITRATE~SAGENT PHARMS~30M
G/ML~A~090585~001~AP~Aug 30, 2011~No~RX~SAGENT PHARMACEUTICALS INC
ORPHENADRINE CITRATE~INJECTABLE;INJECTION~ORPHENADRINE CITRATE~WATSON LABS~30MG/
ML~A~084779~001~AP~Mar 15, 1982~No~RX~WATSON LABORATORIES INC
ORPHENADRINE CITRATE~INJECTABLE;INJECTION~ORPHENADRINE CITRATE~WATSON LABS~30MG/
MANNITOL~INJECTABLE;INJECTION~OSMITROL 10% IN WATER~BAXTER HLTHCARE~10GM/100ML~N
~013684~002~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
MANNITOL~INJECTABLE;INJECTION~OSMITROL 10% IN WATER IN PLASTIC CONTAINER~BAXTER
HLTHCARE~10GM/100ML~N~013684~006~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER H
EALTHCARE CORP
EALTHCARE CORP
EALTHCARE CORP
MANNITOL~INJECTABLE;INJECTION~OSMITROL 5% IN WATER~BAXTER HLTHCARE~5GM/100ML~N~0
13684~001~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
MANNITOL~INJECTABLE;INJECTION~OSMITROL 5% IN WATER IN PLASTIC CONTAINER~BAXTER H
LTHCARE~5GM/100ML~N~013684~005~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEA
LTHCARE CORP
TECHNETIUM TC-99M MEDRONATE KIT~INJECTABLE;INJECTION~OSTEOLITE~PHARMALUCENCE~N/A
~N~017972~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMALUCENCE INC
TECHNETIUM TC-99M ETIDRONATE KIT~INJECTABLE;INJECTION~OSTEOSCAN~MALLINCKRODT~N/A
~N~017454~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT INC

CHORIOGONADOTROPIN ALFA~INJECTABLE;INJECTION~OVIDREL~EMD SERONO~0.25MG/VIAL~N~02
1149~001~~Sep 20, 2000~No~DISCN~EMD SERONO INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~AGILA SPECLTS~EQ 1GM BASE
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~AGILA SPECLTS~EQ 2GM BASE
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~APOTHECON~EQ 1GM BASE/VIA
L~N~050195~003~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL MYE
RS SQUIBB CO
RS SQUIBB CO
RS SQUIBB CO
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~APOTHECON~EQ 250MG BASE/V
IAL~N~050195~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL M
YERS SQUIBB CO
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~APOTHECON~EQ 500MG BASE/V
IAL~N~050195~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL M
YERS SQUIBB CO
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~AUROBINDO PHARMA LTD~EQ 1
GM BASE/VIAL~A~201539~001~AP~Jan 18, 2013~No~RX~AUROBINDO PHARMA LTD
GM BASE/VIAL~A~201539~002~AP~Jan 18, 2013~No~RX~AUROBINDO PHARMA LTD
0GM BASE/VIAL~A~201538~001~AP~Jan 18, 2013~No~RX~AUROBINDO PHARMA LTD
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~ELKINS SINN~EQ 1GM BASE/V
IAL~A~062711~003~~Feb 3, 1989~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~ELKINS SINN~EQ 10GM BASE/
VIAL~A~062711~006~~Feb 3, 1989~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~ELKINS SINN~EQ 250MG BASE
/VIAL~A~062711~001~~Feb 3, 1989~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~ELKINS SINN~EQ 500MG BASE
/VIAL~A~062711~002~~Feb 3, 1989~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~ISTITUTO BIO ITA SPA~EQ 1
GM BASE/VIAL~A~062798~001~~Dec 11, 1995~No~DISCN~ISTITUTO BIOCHIMICO ITALIANO SP
A
GM BASE/VIAL~A~062798~002~~Dec 11, 1995~No~DISCN~ISTITUTO BIOCHIMICO ITALIANO SP
A
25MG BASE/VIAL~A~062798~003~~Dec 11, 1995~No~DISCN~ISTITUTO BIOCHIMICO ITALIANO
SPA
SPA
SPA
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~SAGENT PHARMS~EQ 1GM BASE
/VIAL~A~091246~001~AP~Mar 30, 2012~No~RX~SAGENT PHARMACEUTICALS INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~SAGENT PHARMS~EQ 2GM BASE
/VIAL~A~091246~002~AP~Mar 30, 2012~No~RX~SAGENT PHARMACEUTICALS INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~SAGENT PHARMS~EQ 10GM BAS
E/VIAL~A~091245~001~AP~Mar 30, 2012~No~RX~SAGENT PHARMACEUTICALS INC

OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~SANDOZ~EQ 1GM BASE/VIAL~A
~061490~003~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~SANDOZ~EQ 2GM BASE/VIAL~A
~061490~004~AP~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~SANDOZ~EQ 10GM BASE/VIAL~
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~SANDOZ~EQ 250MG BASE/VIAL
~A~061490~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~SANDOZ~EQ 500MG BASE/VIAL
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~WATSON LABS INC~EQ 1GM BA
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~WATSON LABS INC~EQ 10GM B
ASE/VIAL~A~062984~001~~Sep 29, 1988~No~DISCN~WATSON LABORATORIES INC
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~WATSON LABS INC~EQ 250MG
OXACILLIN SODIUM~INJECTABLE;INJECTION~OXACILLIN SODIUM~WATSON LABS INC~EQ 500MG
IOXILAN~INJECTABLE;INJECTION~OXILAN-300~GUERBET~62%~N~020316~001~~Dec 21, 1995~N
o~RX~GUERBET LLC
IOXILAN~INJECTABLE;INJECTION~OXILAN-350~GUERBET~73%~N~020316~002~~Dec 21, 1995~N
o~RX~GUERBET LLC
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~EUROHLTH INTL SARL~10USP UNITS/ML (10USP
UNITS/ML)~N~018243~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~EUROHEALTH INTERN
ATIONAL SARL
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~EUROHLTH INTL SARL~100USP UNITS/10ML (10U
SP UNITS/ML)~N~018243~002~AP~Jan 10, 2007~Yes~RX~EUROHEALTH INTERNATIONAL SARL
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~FRESENIUS KABI USA~10USP UNITS/ML (10USP
UNITS/ML)~N~018248~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI US
A LLC
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~FRESENIUS KABI USA~100USP UNITS/10ML (10U
SP UNITS/ML)~N~018248~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI
USA LLC
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~FRESENIUS KABI USA~300USP UNITS/30ML (10U
SP UNITS/ML)~N~018248~003~~Jul 27, 2007~Yes~RX~FRESENIUS KABI USA LLC
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~HIKMA FARMACEUTICA~10USP UNITS/ML (10USP
UNITS/ML)~A~200219~001~AP~Feb 13, 2013~No~RX~HIKMA FARMACEUTICA PORTUGAL SA
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~SAGENT PHARMS~10USP UNITS/ML (10USP UNITS
/ML)~A~091676~001~AP~Oct 29, 2014~No~RX~SAGENT PHARMACEUTICALS INC
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~SAGENT PHARMS~100USP UNITS/10ML (10USP UN
ITS/ML)~A~091676~002~AP~Oct 29, 2014~No~RX~SAGENT PHARMACEUTICALS INC
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~TEVA PHARMS USA~10USP UNITS/ML (10USP UNI
TS/ML)~A~077453~001~~Jan 24, 2008~No~DISCN~TEVA PHARMACEUTICALS USA
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN~TEVA PHARMS USA~100USP UNITS/10ML (10USP
UNITS/ML)~A~077453~002~~Jan 24, 2008~No~DISCN~TEVA PHARMACEUTICALS USA
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN 10 USP UNITS IN DEXTROSE 5%~ABBOTT~1USP U
NITS/100ML~N~019185~004~~Mar 29, 1985~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICA
L PRODUCTS DIV
L PRODUCTS DIV
L PRODUCTS DIV
OXYTOCIN~INJECTABLE;INJECTION~OXYTOCIN 5 USP UNITS IN DEXTROSE 5%~ABBOTT~1USP UN
ITS/100ML~N~019185~001~~Mar 29, 1985~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL

PRODUCTS DIV
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~ACCORD HLTHCARE~6MG/ML~A~075436~001~~
Nov 12, 2004~No~DISCN~ACCORD HEALTHCARE INC
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~ACTAVIS TOTOWA~6MG/ML~A~090130~001~AP
~Dec 9, 2009~No~RX~ACTAVIS TOTOWA LLC
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~EBEWE PHARMA~6MG/ML~A~078167~001~AP~D
ec 26, 2007~No~RX~EBEWE PHARMA GES MBH NFG KG
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~EUROHLTH INTL SARL~6MG/ML~A~075190~00
1~AP~Jan 28, 2002~No~RX~EUROHEALTH INTERNATIONAL SARL
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~FRESENIUS KABI ONCOL~6MG/ML~A~077574~
001~AP~Nov 27, 2006~No~RX~FRESENIUS KABI ONCOLOGY PLC
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~HOSPIRA~6MG/ML~A~076131~001~AP~May 8,
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~HOSPIRA~6MG/ML~A~076233~001~~Aug 1, 2
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~MYLAN~6MG/ML~A~075278~001~~Jan 25, 20
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~ONCO THERAPIES LTD~6MG/ML~A~091540~00
1~AP~Sep 29, 2011~No~RX~ONCO THERAPIES LTD
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~PLIVA LACHEMA~6MG/ML~A~077413~001~~Ma
r 12, 2008~No~DISCN~PLIVA LACHEMA AS
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~TEVA PHARMS~6MG/ML~A~075184~001~AP~Ja
n 25, 2002~No~RX~TEVA PHARMACEUTICALS USA
PACLITAXEL~INJECTABLE;INJECTION~PACLITAXEL~TEVA PHARMS USA~6MG/ML~A~075297~001~~
Jan 25, 2002~No~DISCN~TEVA PHARMACEUTICALS USA
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~AESGEN~30MG/VIAL~
A~075594~001~~May 6, 2002~No~DISCN~AESGEN INC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~AESGEN~90MG/VIAL~
A~075594~002~~May 6, 2002~No~DISCN~AESGEN INC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~AGILA SPECLTS~30M
G/10ML (3MG/ML)~A~078520~001~AP~Oct 31, 2008~No~RX~AGILA SPECIALTIES PRIVATE LTD
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~AGILA SPECLTS~90M
G/10ML (9MG/ML)~A~078520~002~AP~Oct 31, 2008~No~RX~AGILA SPECIALTIES PRIVATE LTD
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~AREVA PHARMS~30MG
/VIAL~A~077433~001~AP~Nov 26, 2008~No~RX~AREVA PHARMACEUTICALS INC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~EUROHLTH INTL SAR
L~30MG/VIAL~A~075290~001~AP~Apr 30, 2001~No~RX~EUROHEALTH INTERNATIONAL SARL
L~30MG/10ML (3MG/ML)~N~021113~001~AP~Mar 4, 2002~Yes~RX~EUROHEALTH INTERNATIONAL
SARL
L~90MG/VIAL~A~075290~003~AP~Apr 30, 2001~No~RX~EUROHEALTH INTERNATIONAL SARL
L~90MG/10ML (9MG/ML)~N~021113~002~AP~Mar 4, 2002~Yes~RX~EUROHEALTH INTERNATIONAL
SARL
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~FRESENIUS KABI US
A~30MG/VIAL~A~075773~001~AP~May 6, 2002~No~RX~FRESENIUS KABI USA LLC
A~30MG/10ML (3MG/ML)~A~076207~001~AP~May 17, 2002~No~RX~FRESENIUS KABI USA LLC
A~90MG/VIAL~A~075773~002~AP~May 6, 2002~No~RX~FRESENIUS KABI USA LLC
A~90MG/10ML (9MG/ML)~A~076207~002~AP~May 17, 2002~No~RX~FRESENIUS KABI USA LLC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~HOSPIRA~30MG/10ML
(3MG/ML)~A~075841~001~AP~Jun 27, 2002~Yes~RX~HOSPIRA INC

PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~LUITPOLD~30MG/10M
L (3MG/ML)~A~078942~001~AP~Jul 25, 2008~No~RX~LUITPOLD PHARMACEUTICALS INC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~LUITPOLD~90MG/10M
L (9MG/ML)~A~078942~002~AP~Jul 25, 2008~No~RX~LUITPOLD PHARMACEUTICALS INC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~MN PHARMS~30MG/VI
AL~A~078300~001~~Mar 10, 2009~No~DISCN~MN PHARMACEUTICALS
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~MN PHARMS~90MG/VI
AL~A~078300~002~~Mar 10, 2009~No~DISCN~MN PHARMACEUTICALS
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~MUSTAFA NEVZAT~30
MG/10ML (3MG/ML)~A~078373~001~AP~Dec 23, 2008~No~RX~MUSTAFA NEVZAT ILAC SANAYII
AS
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~MUSTAFA NEVZAT~90
MG/10ML (9MG/ML)~A~078373~002~AP~Dec 23, 2008~No~RX~MUSTAFA NEVZAT ILAC SANAYII
AS
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~PLIVA LACHEMA~30M
G/10ML (3MG/ML)~A~078156~001~AP~Aug 19, 2008~No~RX~PLIVA LACHEMA AS
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~SUN PHARMA GLOBAL
~30MG/VIAL~A~077703~001~AP~Dec 24, 2008~No~RX~SUN PHARMA GLOBAL INC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~SUN PHARMA GLOBAL
~90MG/VIAL~A~077703~002~AP~Dec 24, 2008~No~RX~SUN PHARMA GLOBAL INC
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~TEVA PHARMS USA~3
0MG/10ML (3MG/ML)~A~076153~001~AP~Mar 27, 2002~No~RX~TEVA PHARMACEUTICALS USA
PAMIDRONATE DISODIUM~INJECTABLE;INJECTION~PAMIDRONATE DISODIUM~TEVA PHARMS USA~9
0MG/10ML (9MG/ML)~A~076153~002~AP~Mar 27, 2002~No~RX~TEVA PHARMACEUTICALS USA
PANCURONIUM BROMIDE~INJECTABLE;INJECTION~PANCURONIUM BROMIDE~ASTRAZENECA~1MG/ML~
A~072210~001~~Mar 31, 1988~No~DISCN~ASTRAZENECA LP
PANCURONIUM BROMIDE~INJECTABLE;INJECTION~PANCURONIUM BROMIDE~ELKINS SINN~1MG/ML~
A~072058~001~~Mar 23, 1988~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
PANCURONIUM BROMIDE~INJECTABLE;INJECTION~PANCURONIUM BROMIDE~HOSPIRA~1MG/ML~A~07
PANCURONIUM BROMIDE~INJECTABLE;INJECTION~PANCURONIUM BROMIDE~HOSPIRA~2MG/ML~A~07
2321~001~~Jan 19, 1989~No~DISCN~HOSPIRA INC
PANCURONIUM BROMIDE~INJECTABLE;INJECTION~PANCURONIUM BROMIDE~TEVA PHARMS USA~1MG
/ML~A~072759~001~AP~Jul 31, 1990~Yes~RX~TEVA PHARMACEUTICALS USA
PANCURONIUM BROMIDE~INJECTABLE;INJECTION~PANCURONIUM BROMIDE~TEVA PHARMS USA~2MG
/ML~A~072760~001~AP~Jul 31, 1990~Yes~RX~TEVA PHARMACEUTICALS USA
HEPARIN SODIUM~INJECTABLE;INJECTION~PANHEPRIN~HOSPIRA~1,000 UNITS/ML~N~005264~00

IOPHENDYLATE~INJECTABLE;INJECTION~PANTOPAQUE~ALCON~100%~N~005319~001~~Approved P
rior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
CARBOPLATIN~INJECTABLE;INJECTION~PARAPLATIN~CORDEN PHARMA~50MG/VIAL~N~019880~001
~~Mar 3, 1989~No~DISCN~CORDEN PHARMA LATINA SPA
2~~Mar 3, 1989~No~DISCN~CORDEN PHARMA LATINA SPA
3~~Mar 3, 1989~No~DISCN~CORDEN PHARMA LATINA SPA
TERIPARATIDE ACETATE~INJECTABLE;INJECTION~PARATHAR~SANOFI AVENTIS US~200 UNITS/V
IAL~N~019498~001~~Dec 23, 1987~No~DISCN~SANOFI AVENTIS US LLC
TRIDIHEXETHYL CHLORIDE~INJECTABLE;INJECTION~PATHILON~LEDERLE~10MG/ML~N~009729~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYAN
AMID CO
PANCURONIUM BROMIDE~INJECTABLE;INJECTION~PAVULON~ORGANON USA INC~1MG/ML~N~017015
~002~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
PANCURONIUM BROMIDE~INJECTABLE;INJECTION~PAVULON~ORGANON USA INC~2MG/ML~N~017015
~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~PENBRITIN-S~WYETH AYERST~EQ 1GM BASE/VIAL
~N~050072~004~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
AMPICILLIN SODIUM~INJECTABLE;INJECTION~PENBRITIN-S~WYETH AYERST~EQ 125MG BASE/VI
AL~N~050072~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIE
S
S
S
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~APOTHECON~1,0
00,000 UNITS/VIAL~A~060362~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~APOTHECON~5,0
00,000 UNITS/VIAL~A~060362~003~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~APOTHECON~10,
000,000 UNITS/VIAL~A~060362~004~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~APOTHECON~20,
000,000 UNITS/VIAL~A~060362~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~CONSOLIDATED
PHARM~500,000 UNITS/VIAL~A~060806~001~~Approved Prior to Jan 1, 1982~No~DISCN~CO
NSOLIDATED PHARMACEUTICAL GROUP INC
PHARM~1,000,000 UNITS/VIAL~A~060806~002~~Approved Prior to Jan 1, 1982~No~DISCN~
CONSOLIDATED PHARMACEUTICAL GROUP INC
PHARM~5,000,000 UNITS/VIAL~A~060806~003~~Approved Prior to Jan 1, 1982~No~DISCN~
CONSOLIDATED PHARMACEUTICAL GROUP INC
PHARM~10,000,000 UNITS/VIAL~A~060806~004~~Approved Prior to Jan 1, 1982~No~DISCN
~CONSOLIDATED PHARMACEUTICAL GROUP INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~HANFORD GC~1,

000,000 UNITS/VIAL~A~065149~001~~Jul 23, 2009~No~RX~GC HANFORD MANUFACTURING CO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~HANFORD GC~5,
000,000 UNITS/VIAL~A~065149~002~AP~Jul 23, 2009~No~RX~GC HANFORD MANUFACTURING C
O
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~HANFORD GC~20
,000,000 UNITS/VIAL~A~065149~003~AP~Jul 23, 2009~No~RX~GC HANFORD MANUFACTURING
CO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~ISTITUTO BIO
ITA SPA~5,000,000 UNITS/VIAL~A~065448~001~AP~Aug 18, 2009~No~RX~ISTITUTO BIOCHIM
ICO ITALIANO SPA
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~ISTITUTO BIO
ITA SPA~20,000,000 UNITS/VIAL~A~065448~002~AP~Aug 18, 2009~No~RX~ISTITUTO BIOCHI
MICO ITALIANO SPA
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~LILLY~200,000
UNITS/VIAL~A~060384~004~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND C
O
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~LILLY~500,000
UNITS/VIAL~A~060384~003~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND C
O
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~LILLY~1,000,0
00 UNITS/VIAL~A~060384~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND
CO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~LILLY~5,000,0
00 UNITS/VIAL~A~060384~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND
CO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~LILLY~20,000,
000 UNITS/VIAL~A~060384~005~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AN
D CO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~LILLY~20,000,
000 UNITS/VIAL~A~060601~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AN
D CO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~PARKE DAVIS~1
,000,000 UNITS/VIAL~A~062003~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE D
AVIS DIV WARNER LAMBERT CO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~PARKE DAVIS~5
,000,000 UNITS/VIAL~A~062003~002~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE D
AVIS DIV WARNER LAMBERT CO
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~PFIZER~20,000
,000 UNITS/VIAL~A~060074~003~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABO
RATORIES DIV PFIZER INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~SANDOZ~1,000,
000 UNITS/VIAL **Federal Register determination that product was not discontinue
d or withdrawn for safety or efficacy reasons**~A~065079~001~~Aug 30, 2002~No~DI
SCN~SANDOZ INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~SANDOZ~5,000,
000 UNITS/VIAL~A~065079~002~AP~Aug 30, 2002~No~RX~SANDOZ INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~SANDOZ~20,000
,000 UNITS/VIAL~A~065079~003~AP~Aug 30, 2002~No~RX~SANDOZ INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM~WATSON LABS I
NC~1,000,000 UNITS/VIAL~A~062991~001~~Sep 13, 1988~No~DISCN~WATSON LABORATORIES
INC
INC
INC
INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PENICILLIN G POTASSIUM IN PLASTIC CO
NTAINER~BAXTER HLTHCARE~20,000 UNITS/ML~N~050638~001~~Jun 25, 1990~Yes~RX~BAXTER
HEALTHCARE CORP
HEALTHCARE CORP
HEALTHCARE CORP
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PENICILLIN G PROCAINE~CONSOLIDATED PH
ARM~300,000 UNITS/ML~A~060800~001~~Approved Prior to Jan 1, 1982~No~DISCN~CONSOL
IDATED PHARMACEUTICAL GROUP INC
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PENICILLIN G PROCAINE~CONSOLIDATED PH
ARM~600,000 UNITS/1.2ML~A~060800~002~~Approved Prior to Jan 1, 1982~No~DISCN~CON
SOLIDATED PHARMACEUTICAL GROUP INC
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PENICILLIN G PROCAINE~KING PHARMS~300
,000 UNITS/ML~A~060101~002~~Approved Prior to Jan 1, 1982~Yes~RX~KING PHARMACEUT
ICALS INC
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PENICILLIN G PROCAINE~KING PHARMS~600
,000 UNITS/ML~A~060101~001~~Approved Prior to Jan 1, 1982~Yes~RX~KING PHARMACEUT
ICALS INC
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PENICILLIN G PROCAINE~PARKE DAVIS~300
,000 UNITS/ML~A~062029~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS D
IV WARNER LAMBERT CO
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PENICILLIN G PROCAINE~PFIZER~300,000
UNITS/VIAL~A~060099~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATOR
IES DIV PFIZER INC
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PENICILLIN G PROCAINE~PFIZER~1,500,00
0 UNITS/VIAL~A~060099~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORAT
ORIES DIV PFIZER INC
PENICILLIN G SODIUM~INJECTABLE;INJECTION~PENICILLIN G SODIUM~BRISTOL MYERS SQUIB
B~5,000,000 UNITS/VIAL~A~061935~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRIS
TOL MYERS SQUIBB SPA
PENICILLIN G SODIUM~INJECTABLE;INJECTION~PENICILLIN G SODIUM~COPANOS~5,000,000 U
NITS/VIAL~A~061051~001~~Approved Prior to Jan 1, 1982~No~DISCN~JOHN D COPANOS AN
D CO INC
PENICILLIN G SODIUM~INJECTABLE;INJECTION~PENICILLIN G SODIUM~PHARMACIA AND UPJOH
N~1,000,000 UNITS/VIAL~A~061046~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHAR
MACIA AND UPJOHN CO
PENTAMIDINE ISETHIONATE~INJECTABLE;INJECTION~PENTACARINAT~ARMOUR PHARM~300MG/VIA
L~A~073447~001~~Apr 28, 1994~No~DISCN~ARMOUR PHARMACEUTICAL CO
CEFTAZIDIME~INJECTABLE;INJECTION~PENTACEF~GLAXOSMITHKLINE~1GM/VIAL~A~063322~001~
~Nov 7, 1995~No~DISCN~GLAXOSMITHKLINE
~Mar 31, 1992~No~DISCN~GLAXOSMITHKLINE
~Nov 7, 1995~No~DISCN~GLAXOSMITHKLINE
CEFTAZIDIME~INJECTABLE;INJECTION~PENTACEF~GLAXOSMITHKLINE~10GM/VIAL~A~064008~002
~~Mar 31, 1992~No~DISCN~GLAXOSMITHKLINE
PENTAMIDINE ISETHIONATE~INJECTABLE;INJECTION~PENTAM~FRESENIUS KABI USA~300MG/VIA
L~N~019264~001~~Oct 16, 1984~Yes~RX~FRESENIUS KABI USA LLC
PENTAMIDINE ISETHIONATE~INJECTABLE;INJECTION~PENTAMIDINE ISETHIONATE~BAXTER HLTH
CARE~300MG/VIAL~A~073617~001~~Dec 18, 1995~No~DISCN~BAXTER HEALTHCARE CORP ANEST
HESIA AND CRITICAL CARE
PENTAMIDINE ISETHIONATE~INJECTABLE;INJECTION~PENTAMIDINE ISETHIONATE~HOSPIRA~300
MG/VIAL~A~073479~001~~Jun 30, 1992~No~DISCN~HOSPIRA INC

PENTAMIDINE ISETHIONATE~INJECTABLE;INJECTION~PENTAMIDINE ISETHIONATE~WATSON LABS
~300MG/VIAL~A~074303~001~~Aug 17, 1995~No~DISCN~WATSON LABORATORIES INC
PENTOBARBITAL SODIUM~INJECTABLE;INJECTION~PENTOBARBITAL SODIUM~ELKINS SINN~50MG/
ML~A~083270~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBIN
S CO INC
PENTOSTATIN~INJECTABLE;INJECTION~PENTOSTATIN~EUROHLTH INTL SARL~10MG/VIAL~A~0778
PENTOSTATIN~INJECTABLE;INJECTION~PENTOSTATIN~MYLAN INSTITUTIONAL~10MG/VIAL~A~203
554~001~AP~Sep 19, 2014~No~RX~MYLAN INSTITUTIONAL LLC
FAMOTIDINE~INJECTABLE;INJECTION~PEPCID~MERCK~10MG/ML~N~019510~001~~Nov 4, 1986~N
o~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
FAMOTIDINE~INJECTABLE;INJECTION~PEPCID PRESERVATIVE FREE~MERCK~10MG/ML~N~019510~
004~~Nov 4, 1986~No~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
FAMOTIDINE~INJECTABLE;INJECTION~PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER~ME
RCK SHARP DOHME~0.4MG/ML~N~020249~001~~Feb 18, 1994~No~DISCN~MERCK SHARP AND DOH
ME CORP
PENTAGASTRIN~INJECTABLE;INJECTION~PEPTAVLON~WYETH AYERST~0.25MG/ML **Federal Reg
efficacy reasons**~N~017048~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH A
YERST LABORATORIES
DESOXYCORTICOSTERONE PIVALATE~INJECTABLE;INJECTION~PERCORTEN~NOVARTIS~25MG/ML~N~
MENOTROPINS (FSH;LH)~INJECTABLE;INJECTION~PERGONAL~SERONO~75 IU/AMP;75 IU/AMP~N~
017646~001~~Approved Prior to Jan 1, 1982~No~DISCN~SERONO LABORATORIES INC
MENOTROPINS (FSH;LH)~INJECTABLE;INJECTION~PERGONAL~SERONO~150 IU/AMP;150 IU/AMP~
N~017646~002~~May 20, 1985~No~DISCN~SERONO LABORATORIES INC
PENICILLIN G BENZATHINE~INJECTABLE;INJECTION~PERMAPEN~PFIZER~600,000 UNITS/ML~A~
060014~001~BC~Approved Prior to Jan 1, 1982~No~RX~PFIZER LABORATORIES DIV PFIZER
INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PFIZERPEN~PFIZER~1,000,000 UNITS/VIA
L **Federal Register determination that product was not discontinued or withdraw
n for safety or efficacy reasons**~A~060657~001~~Approved Prior to Jan 1, 1982~N
o~DISCN~PFIZER LABORATORIES DIV PFIZER INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PFIZERPEN~PFIZER~5,000,000 UNITS/VIA
L~A~060657~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV P
FIZER INC
PENICILLIN G POTASSIUM~INJECTABLE;INJECTION~PFIZERPEN~PFIZER~20,000,000 UNITS/VI
AL~A~060657~003~AP~Approved Prior to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV
PFIZER INC
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PFIZERPEN-AS~PFIZER~300,000 UNITS/ML~
A~060286~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFI
ZER INC
PENICILLIN G PROCAINE~INJECTABLE;INJECTION~PFIZERPEN-AS~PFIZER~600,000 UNITS/ML~
A~060286~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFI
ZER INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PHENERGAN~WYETH AYERST~25MG/ML~N
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PHENERGAN~WYETH AYERST~50MG/ML~N
PHENTOLAMINE MESYLATE~INJECTABLE;INJECTION~PHENTOLAMINE MESYLATE~EUROHLTH INTL S
ARL~5MG/VIAL~A~040235~001~AP~Mar 11, 1998~No~RX~EUROHEALTH INTERNATIONAL SARL
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~EUROHLTH INTL SARL~50MG/M
L~A~084307~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~EUROHEALTH INTERNATIONAL
SARL
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~FRESENIUS KABI USA~50MG/M
L~A~089003~001~~May 31, 1985~No~DISCN~FRESENIUS KABI USA LLC
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~HOSPIRA~50MG/ML~A~089521~
001~AP~Mar 17, 1987~No~RX~HOSPIRA INC
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~HOSPIRA~50MG/ML~A~089744~
001~~Dec 18, 1987~No~DISCN~HOSPIRA INC

PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~LUITPOLD~50MG/ML~A~040781
~001~AP~Dec 4, 2007~No~RX~LUITPOLD PHARMACEUTICALS INC
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~MARSAM PHARMS LLC~50MG/ML
~A~089501~001~~Oct 13, 1987~No~DISCN~MARSAM PHARMACEUTICALS LLC
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~MARSAM PHARMS LLC~50MG/ML
~A~089779~001~~Nov 27, 1992~No~DISCN~MARSAM PHARMACEUTICALS LLC
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~SMITH AND NEPHEW~50MG/ML~
A~088519~001~~Dec 19, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHE
W
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~SMITH AND NEPHEW~50MG/ML~
A~088521~001~~Dec 18, 1984~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHE
W
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~SOLOPAK~50MG/ML~A~088520~
001~~Dec 17, 1984~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~WARNER CHILCOTT~50MG/ML~A
~089900~001~~Mar 30, 1990~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~WATSON LABS~50MG/ML~A~085
PHENYTOIN SODIUM~INJECTABLE;INJECTION~PHENYTOIN SODIUM~X-GEN PHARMS~50MG/ML~A~04
0573~001~AP~Sep 13, 2006~No~RX~X-GEN PHARMACEUTICALS INC
CHROMIC PHOSPHATE P-32~INJECTABLE;INJECTION~PHOSPHOCOL P32~MALLINCKRODT~5mCi/ML~
N~017084~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
TECHNETIUM TC-99M PYROPHOSPHATE KIT~INJECTABLE;INJECTION~PHOSPHOTEC~BRACCO~N/A~N
~017680~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
PORFIMER SODIUM~INJECTABLE;INJECTION~PHOTOFRIN~CONCORDIA LABS INC~75MG/VIAL~N~02
0451~001~~Dec 27, 1995~No~RX~CONCORDIA LABORATORIES INC
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SO
DIUM CHLORIDE; SODIUM PHOSPHATE~INJECTABLE;INJECTION~PHOXILLUM B22K 4/0 IN PLAST
IC CONTAINER~GAMBRO LUNDIA~N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML
;6.95GM/1000ML;0.187GM/1000ML (5000ML)~N~207026~002~~Jan 13, 2015~Yes~RX~GAMBRO
LUNDIA AB
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SO
DIUM CHLORIDE; SODIUM PHOSPHATE~INJECTABLE;INJECTION~PHOXILLUM BK 4/2.5 IN PLAST
IC CONTAINER~GAMBRO LUNDIA~3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/10
00ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)~N~207026~001~~Jan 13, 2015~Yes~RX~GAM
BRO LUNDIA AB
PHYTONADIONE~INJECTABLE;INJECTION~PHYTONADIONE~GLAXOSMITHKLINE~1MG/0.5ML~A~08406
PHYTONADIONE~INJECTABLE;INJECTION~PHYTONADIONE~GLAXOSMITHKLINE~10MG/ML~A~084060~
PHYTONADIONE~INJECTABLE;INJECTION~PHYTONADIONE~INTL MEDICATION~1MG/0.5ML~A~08372
2~001~BP~Approved Prior to Jan 1, 1982~Yes~RX~INTERNATIONAL MEDICATION SYSTEM
PIPERACILLIN SODIUM~INJECTABLE;INJECTION~PIPERACILLIN~ISTITUTO BIO ITA SPA~EQ 2G
M BASE/VIAL~A~065114~001~~Nov 14, 2003~Yes~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
PIPERACILLIN SODIUM~INJECTABLE;INJECTION~PIPERACILLIN~ISTITUTO BIO ITA SPA~EQ 40
GM BASE/VIAL~A~065157~001~~Jul 12, 2004~Yes~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM~INJECTABLE;INJECTION~PIPERACILLIN AND TAZ
OBACTAM~AGILA SPECLTS~EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL~A~065458~001~AP~Aug 15
, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD
OBACTAM~AGILA SPECLTS~EQ 3MG BASE/VIAL;EQ 375MG BASE/VIAL~A~065458~002~AP~Aug 15
OBACTAM~AGILA SPECLTS~EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL~A~065458~003~AP~Aug 15

OBACTAM~AUROBINDO PHARMA LTD~EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL~A~065498~001~AP
~May 23, 2011~No~RX~AUROBINDO PHARMA LTD
OBACTAM~HOSPIRA INC~EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL~A~065386~001~AP~Sep 15,
OBACTAM~HOSPIRA INC~EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL~A~065446~001~AP~Sep 15,
OBACTAM~ISTITUTO BIO ITA SPA~EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL~A~065523~001~AP
~May 31, 2011~No~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
OBACTAM~ISTITUTO BIO ITA SPA~EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL~A~090498~001~A
P~May 31, 2011~No~RX~ISTITUTO BIOCHIMICO ITALIANO SPA
OBACTAM~SANDOZ~EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL~A~065362~001~AP~Oct 21, 2010~
No~RX~SANDOZ INC
No~RX~SANDOZ INC
No~RX~SANDOZ INC
No~RX~SANDOZ INC
No~RX~SANDOZ INC
No~RX~SANDOZ INC
PIPERACILLIN SODIUM~INJECTABLE;INJECTION~PIPRACIL~WYETH PHARMS INC~EQ 2GM BASE/V
IAL~A~062750~001~~Oct 13, 1987~No~DISCN~WYETH PHARMACEUTICALS INC
IAL~N~050545~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICALS I
NC
NC
NC
PIPERACILLIN SODIUM~INJECTABLE;INJECTION~PIPRACIL~WYETH PHARMS INC~EQ 40GM BASE/
VIAL~N~050545~006~~Sep 30, 1985~No~DISCN~WYETH PHARMACEUTICALS INC
OXYTOCIN~INJECTABLE;INJECTION~PITOCIN~PAR STERILE PRODUCTS~10USP UNITS/ML (10USP
UNITS/ML)~N~018261~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PROD
UCTS LLC
OXYTOCIN~INJECTABLE;INJECTION~PITOCIN~PAR STERILE PRODUCTS~100USP UNITS/10ML (10
USP UNITS/ML)~N~018261~002~AP~Jul 27, 2007~No~RX~PAR STERILE PRODUCTS LLC
OXYTOCIN~INJECTABLE;INJECTION~PITOCIN~PAR STERILE PRODUCTS~500USP UNITS/50ML (10
USP UNITS/ML)~N~018261~003~~Sep 5, 2012~No~RX~PAR STERILE PRODUCTS LLC
VASOPRESSIN TANNATE~INJECTABLE;INJECTION~PITRESSIN TANNATE~PARKE DAVIS~5PRESSOR
UNITS/ML~N~003402~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WA
RNER LAMBERT CO
E; SODIUM GLUCONATE~INJECTABLE;INJECTION~PLASMA-LYTE 148 AND DEXTROSE 5% IN PLAS
TIC CONTAINER~BAXTER HLTHCARE~5GM/100ML;30MG/100ML;37MG/100ML;368MG/100ML;526MG/
100ML;502MG/100ML~N~017451~001~~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALT
HCARE CORP
GLUCONATE~INJECTABLE;INJECTION~PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER~BAX
TER HLTHCARE~30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML~N~017378~
DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE~INJ
ECTABLE;INJECTION~PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER~BAXTER HLT
HCARE~5GM/100ML;32MG/100ML;128MG/100ML;234MG/100ML~N~017385~001~~Approved Prior
to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE~INJECTABLE;IN
JECTION~PLASMA-LYTE 56 IN PLASTIC CONTAINER~BAXTER HLTHCARE~32MG/100ML;128MG/100
ML;234MG/100ML~N~019047~001~~Jun 15, 1984~No~RX~BAXTER HEALTHCARE CORP
GLUCONATE~INJECTABLE;INJECTION~PLASMA-LYTE A IN PLASTIC CONTAINER~BAXTER HLTHCAR
E~30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML~N~017378~002~AP~Nov
TE; SODIUM CHLORIDE; SODIUM LACTATE~INJECTABLE;INJECTION~PLASMA-LYTE M AND DEXTR
OSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~37MG/100ML;5GM/100ML;30MG/100ML;119M
G/100ML;161MG/100ML;94MG/100ML;138MG/100ML~N~017390~001~~Approved Prior to Jan 1
, 1982~Yes~RX~BAXTER HEALTHCARE CORP
CHLORIDE; SODIUM LACTATE~INJECTABLE;INJECTION~PLASMA-LYTE R IN PLASTIC CONTAINE
R~BAXTER HLTHCARE~36.8MG/100ML;30.5MG/100ML;74.6MG/100ML;640MG/100ML;496MG/100ML
;89.6MG/100ML~N~017438~001~~Approved Prior to Jan 1, 1982~Yes~RX~BAXTER HEALTHCA
RE CORP
CISPLATIN~INJECTABLE;INJECTION~PLATINOL~HQ SPCLT PHARMA~10MG/VIAL~N~018057~001~~
Approved Prior to Jan 1, 1982~No~DISCN~HQ SPECIALTY PHARMA CORP
CISPLATIN~INJECTABLE;INJECTION~PLATINOL~HQ SPCLT PHARMA~50MG/VIAL~N~018057~002~~
Approved Prior to Jan 1, 1982~No~DISCN~HQ SPECIALTY PHARMA CORP
CISPLATIN~INJECTABLE;INJECTION~PLATINOL-AQ~HQ SPCLT PHARMA~0.5MG/ML~N~018057~003
~~Jul 18, 1984~No~DISCN~HQ SPECIALTY PHARMA CORP
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~POLOCAINE~DENTSPLY PHARM~3%~A~088
653~001~~Aug 21, 1984~No~DISCN~DENTSPLY PHARMACEUTICAL
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~POLOCAINE~FRESENIUS KABI USA~1%~A
~089407~001~AP~Dec 1, 1986~No~RX~FRESENIUS KABI USA LLC
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~POLOCAINE~FRESENIUS KABI USA~2%~A
~089410~001~AP~Dec 1, 1986~No~RX~FRESENIUS KABI USA LLC
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~POLOCAINE W/ LEVON

ORDEFRIN~DENTSPLY PHARM~0.05MG/ML;2%~A~089517~001~~Apr 14, 1988~No~DISCN~DENTSPL
Y PHARMACEUTICAL
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~POLOCAINE-MPF~FRESENIUS KABI USA~
1%~A~089406~001~AP~Dec 1, 1986~No~RX~FRESENIUS KABI USA LLC
1.5%~A~089408~001~AP~Dec 1, 1986~No~RX~FRESENIUS KABI USA LLC
2%~A~089409~001~AP~Dec 1, 1986~No~RX~FRESENIUS KABI USA LLC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~POLYCILLIN-N~BRISTOL~EQ 1GM BASE/VIAL~N~0
50309~004~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV B
RISTOL MYERS CO
AMPICILLIN SODIUM~INJECTABLE;INJECTION~POLYCILLIN-N~BRISTOL~EQ 2GM BASE/VIAL~N~0
50309~005~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV B
RISTOL MYERS CO
AMPICILLIN SODIUM~INJECTABLE;INJECTION~POLYCILLIN-N~BRISTOL~EQ 125MG BASE/VIAL~N
BRISTOL MYERS CO
BRISTOL MYERS CO
BRISTOL MYERS CO
POLYMYXIN B SULFATE~INJECTABLE;INJECTION~POLYMYCIN B SULFATE~SAGENT STRIDES~EQ 5
00,000 UNITS BASE/VIAL~A~090110~001~AP~Jun 29, 2011~No~RX~SAGENT STRIDES LLC
POLYMYXIN B SULFATE~INJECTABLE;INJECTION~POLYMYXIN B SULFATE~EUROHLTH INTL SARL~
EQ 500,000 UNITS BASE/VIAL~A~060716~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~
EUROHEALTH INTERNATIONAL SARL
POLYMYXIN B SULFATE~INJECTABLE;INJECTION~POLYMYXIN B SULFATE~FRESENIUS KABI USA~
EQ 500,000 UNITS BASE/VIAL~A~065372~001~AP~Jan 10, 2008~No~RX~FRESENIUS KABI USA
LLC
POLYMYXIN B SULFATE~INJECTABLE;INJECTION~POLYMYXIN B SULFATE~X GEN PHARMS~EQ 500
,000 UNITS BASE/VIAL~A~063000~001~AP~Sep 30, 1994~No~RX~X GEN PHARMACEUTICALS IN
C
POLYMYXIN B SULFATE~INJECTABLE;INJECTION~POLYMYXIN B SULFATE~XELLIA PHARMS APS~E
Q 500,000 UNITS BASE/VIAL~A~202766~001~AP~Jan 15, 2014~No~RX~XELLIA PHARMACEUTIC
ALS APS
POTASSIUM ACETATE~INJECTABLE;INJECTION~POTASSIUM ACETATE IN PLASTIC CONTAINER~HO
SPIRA~2MEQ/ML~N~018896~001~~Jul 20, 1984~Yes~RX~HOSPIRA INC
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~ABRAXIS PHARM~2MEQ/ML
~A~080204~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRO
DUCTS
DUCTS
DUCTS
DUCTS
~A~087787~001~~Apr 20, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
~A~087885~001~~Feb 3, 1983~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~AKORN~2MEQ/ML~A~08828
6~001~~Sep 5, 1985~No~DISCN~AKORN INC
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~B BRAUN~2MEQ/ML~A~085
870~001~AP~Approved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~BAXTER HLTHCARE~2MEQ/

ML~A~080203~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP A
NESTHESIA AND CRITICAL CARE
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~BAXTER HLTHCARE~2MEQ/
ML~A~085499~001~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~FRESENIUS KABI USA~2M
EQ/ML~A~080225~001~AP~Approved Prior to Jan 1, 1982~No~RX~FRESENIUS KABI USA LLC
EQ/ML~A~087817~001~~Oct 20, 1982~No~DISCN~FRESENIUS KABI USA LLC
EQ/ML~A~080225~003~~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~GD SEARLE LLC~1MEQ/ML
~A~086219~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~HOSPIRA~1MEQ/ML~A~080
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~HOSPIRA~1.5MEQ/ML~A~0
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~INTL MEDICATION~2MEQ/
SYSTEM
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~LILLY~2MEQ/ML~N~00786
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~LUITPOLD~2MEQ/ML~A~08
0221~001~~Approved Prior to Jan 1, 1982~No~DISCN~LUITPOLD PHARMACEUTICALS INC
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~MILES~1MEQ/ML~A~08019
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~PHARMA SERVE NY~2MEQ/
ML~A~086297~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMA SERVE INC SUB TOR
IGIAN LABORATORIES
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~PHARMA SERVE NY~2MEQ/
ML~A~087362~001~~Mar 8, 1983~No~DISCN~PHARMA SERVE INC SUB TORIGIAN LABORATORIES
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE~WATSON LABS~2MEQ/ML~A
~089163~001~~Mar 10, 1988~No~DISCN~WATSON LABORATORIES INC
~089421~001~~Jan 2, 1987~No~DISCN~WATSON LABORATORIES INC
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHL
ORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER~B BRA
UN~10GM/100ML;37MG/100ML;200MG/100ML~N~019630~031~~Feb 17, 1988~No~RX~B BRAUN ME
DICAL INC
ORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~B BR
AUN~10GM/100ML;37MG/100ML;450MG/100ML~N~019630~037~~Feb 17, 1988~No~RX~B BRAUN M
EDICAL INC
DICAL INC
UN~5GM/100ML;37MG/100ML;110MG/100ML~N~019630~001~~Feb 17, 1988~No~RX~B BRAUN MED
ICAL INC
ORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER~B BRAU
N~5GM/100ML;37MG/100ML;200MG/100ML~N~019630~007~~Feb 17, 1988~No~RX~B BRAUN MEDI
CAL INC
ICAL INC
ICAL INC
N~5GM/100ML;37MG/100ML;900MG/100ML~N~019630~025~~Feb 17, 1988~No~RX~B BRAUN MEDI
CAL INC
DEXTROSE; POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 0.037% IN D
EXTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;37MG/100ML~N~019699~001~~Sep 2
POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 0.03
7% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~B BRAUN~37MG/100ML;900MG/100ML~N
~019708~001~~Sep 29, 1989~No~DISCN~B BRAUN MEDICAL INC
DICAL INC
ORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~B BR
AUN~10GM/100ML;75MG/100ML;450MG/100ML~N~019630~038~~Feb 17, 1988~No~RX~B BRAUN M
EDICAL INC
DICAL INC
ORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~B BR
AUN~3.3GM/100ML;75MG/100ML;300MG/100ML~N~019630~049~~May 7, 1992~No~RX~B BRAUN M
EDICAL INC
ICAL INC
N~5GM/100ML;75MG/100ML;200MG/100ML~N~019630~008~AP~Feb 17, 1988~No~RX~B BRAUN ME
DICAL INC
UN~5GM/100ML;75MG/100ML;330MG/100ML~N~019630~014~AP~Feb 17, 1988~No~RX~B BRAUN M
EDICAL INC
UN~5GM/100ML;75MG/100ML;450MG/100ML~N~019630~020~AP~Feb 17, 1988~No~RX~B BRAUN M
EDICAL INC
N~5GM/100ML;75MG/100ML;900MG/100ML~N~019630~026~AP~Feb 17, 1988~No~RX~B BRAUN ME
DICAL INC
EXTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;75MG/100ML~N~018744~001~AP~Nov
EXTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;75MG/100ML~N~019699~002~~Sep 2
5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~B BRAUN~75MG/100ML;900MG/100ML~N
N~10GM/100ML;110MG/100ML;200MG/100ML~N~019630~033~~Feb 17, 1988~No~RX~B BRAUN ME
DICAL INC
UN~10GM/100ML;110MG/100ML;450MG/100ML~N~019630~039~~Feb 17, 1988~No~RX~B BRAUN M
EDICAL INC
DICAL INC
ORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~B BRA
UN~3.3GM/100ML;110MG/100ML;300MG/100ML~N~019630~050~~May 7, 1992~No~RX~B BRAUN M
EDICAL INC
N~5GM/100ML;110MG/100ML;110MG/100ML~N~019630~003~~Feb 17, 1988~No~RX~B BRAUN MED
ICAL INC
ORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER~B BRAUN
~5GM/100ML;110MG/100ML;200MG/100ML~N~019630~009~~Feb 17, 1988~No~RX~B BRAUN MEDI
CAL INC

ICAL INC
ICAL INC
CAL INC
DEXTROSE; POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 0.11% IN DE
XTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;110MG/100ML~N~019699~003~~Sep 2
% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~B BRAUN~110MG/100ML;900MG/100ML~N
9% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~HOSPIRA~149MG/100ML;450MG/100ML
~A~078446~001~AP~Sep 10, 2008~No~RX~HOSPIRA INC
DICAL INC
EDICAL INC
DICAL INC
EDICAL INC
ICAL INC
~5GM/100ML;150MG/100ML;200MG/100ML~N~019630~010~AP~Feb 17, 1988~No~RX~B BRAUN ME
DICAL INC
N~5GM/100ML;150MG/100ML;330MG/100ML~N~019630~016~AP~Feb 17, 1988~No~RX~B BRAUN M
EDICAL INC
N~5GM/100ML;150MG/100ML;450MG/100ML~N~019630~022~AP~Feb 17, 1988~No~RX~B BRAUN M
EDICAL INC
DICAL INC
XTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;150MG/100ML~N~018744~002~AP~Nov
XTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;150MG/100ML~N~019699~004~AP~Sep

% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~BAXTER HLTHCARE~150MG/100ML;450M
G/100ML~N~017648~005~AP~Nov 26, 2002~Yes~RX~BAXTER HEALTHCARE CORP
~019708~004~AP~Sep 29, 1989~No~RX~B BRAUN MEDICAL INC
% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~BAXTER HLTHCARE~150MG/100ML;900MG
/100ML~N~017648~001~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE COR
P
DICAL INC
EDICAL INC
DICAL INC
EDICAL INC
ICAL INC
CAL INC
ICAL INC
ICAL INC
CAL INC
XTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;220MG/100ML~N~018744~003~~Nov 9
, 1982~No~DISCN~B BRAUN MEDICAL INC
XTROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;220MG/100ML~N~019699~005~~Sep 2
4% IN SODIUM CHLORIDE 0.9%~BAXTER HLTHCARE~224MG/100ML;900MG/100ML~N~017648~003~
~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 0.3%
AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~BAXTER HLTHCARE~300MG/100ML;900MG

/100ML~N~017648~002~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE COR
P
~10GM/100ML;300MG/100ML;200MG/100ML~N~019630~036~~Feb 17, 1988~No~RX~B BRAUN MED
ICAL INC
DICAL INC
~10GM/100ML;300MG/100ML;900MG/100ML~N~019630~048~~Feb 17, 1988~No~RX~B BRAUN MED
ICAL INC
ORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~B BRAU
N~3.3GM/100ML;300MG/100ML;300MG/100ML~N~019630~053~~May 7, 1992~No~RX~B BRAUN ME
DICAL INC
CAL INC
ORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER~B BRAUN~
5GM/100ML;300MG/100ML;200MG/100ML~N~019630~012~AP~Feb 17, 1988~No~RX~B BRAUN MED
ICAL INC
DICAL INC
DICAL INC
ORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~B BRAUN~
5GM/100ML;300MG/100ML;900MG/100ML~N~019630~030~AP~Feb 17, 1988~No~RX~B BRAUN MED
ICAL INC
DEXTROSE; POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 0.3% IN DEX
TROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;300MG/100ML~N~018744~004~AP~Nov
DEXTROSE; POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 0.3% IN DEX
TROSE 5% IN PLASTIC CONTAINER~B BRAUN~5GM/100ML;300MG/100ML~N~019699~006~AP~Sep
POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 0.3%
IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~B BRAUN~300MG/100ML;900MG/100ML~N~
019708~006~~Sep 29, 1989~No~DISCN~B BRAUN MEDICAL INC
INJECTABLE;INJECTION~POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER
'S IN PLASTIC CONTAINER~BAXTER HLTHCARE~20MG/100ML;5GM/100ML;105MG/100ML;600MG/1
00ML;310MG/100ML~N~019367~002~~Apr 5, 1985~No~RX~BAXTER HEALTHCARE CORP
'S IN PLASTIC CONTAINER~HOSPIRA~20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310
MG/100ML~N~019685~005~~Oct 17, 1988~No~DISCN~HOSPIRA INC

ORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER~HOSPI
RA~5GM/100ML;74.5MG/100ML;225MG/100ML~N~018365~002~~Jul 5, 1983~No~RX~HOSPIRA IN
C
RA~5GM/100ML;149MG/100ML;225MG/100ML~N~018365~006~~Mar 28, 1988~No~RX~HOSPIRA IN
C
ORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~HOSPIRA
~5GM/100ML;74.5MG/100ML;300MG/100ML~N~018876~001~~Jan 17, 1986~No~RX~HOSPIRA INC
~5GM/100ML;149MG/100ML;300MG/100ML~N~018876~006~~Mar 28, 1988~No~RX~HOSPIRA INC
ORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~BAXTER
HLTHCARE~5GM/100ML;75MG/100ML;450MG/100ML~N~018008~005~AP~Apr 28, 1982~No~RX~BA
HLTHCARE~5GM/100ML;150MG/100ML;450MG/100ML~N~018008~006~AP~Apr 28, 1982~No~RX~B
ORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~HOSPIR
A~5GM/100ML;74.5MG/100ML;450MG/100ML~N~018362~005~AP~Mar 28, 1988~No~RX~HOSPIRA
INC
A~5GM/100ML;74.5MG/100ML;450MG/100ML~N~018362~009~AP~Jul 5, 1983~No~RX~HOSPIRA I
NC
HLTHCARE~5GM/100ML;75MG/100ML;900MG/100ML~N~019308~004~AP~Apr 5, 1985~No~RX~BAXT
ER HEALTHCARE CORP
HLTHCARE~5GM/100ML;150MG/100ML;900MG/100ML~N~019308~002~AP~Apr 5, 1985~No~RX~BAX
TER HEALTHCARE CORP
~5GM/100ML;74.5MG/100ML;900MG/100ML~N~019691~002~AP~Mar 24, 1988~No~RX~HOSPIRA I
NC
~5GM/100ML;149MG/100ML;900MG/100ML~N~019691~004~AP~Mar 24, 1988~No~RX~HOSPIRA IN
C
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONT
AINER~BAXTER HLTHCARE~14.9MG/ML~N~019904~001~AP~Dec 26, 1989~Yes~RX~BAXTER HEALT
HCARE CORP
AINER~BAXTER HLTHCARE~746MG/100ML~N~019904~005~AP~Dec 17, 1990~Yes~RX~BAXTER HEA
LTHCARE CORP
AINER~HOSPIRA~14.9MG/ML~N~020161~005~AP~Nov 30, 1992~No~RX~HOSPIRA INC
AINER~HOSPIRA~745MG/100ML~N~020161~001~AP~Nov 30, 1992~No~RX~HOSPIRA INC

00ML;310MG/100ML~N~019367~006~AP~Apr 5, 1985~No~RX~BAXTER HEALTHCARE CORP
C
A~5GM/100ML;224MG/100ML;450MG/100ML~N~018362~006~AP~Mar 28, 1988~No~RX~HOSPIRA I
NC
C
MG/100ML~N~019685~002~AP~Oct 17, 1988~No~RX~HOSPIRA INC
RA~5GM/100ML;149MG/100ML;225MG/100ML~N~018365~001~~Approved Prior to Jan 1, 1982
~No~RX~HOSPIRA INC
C
A~5GM/100ML;149MG/100ML;450MG/100ML~N~018362~010~AP~Jul 5, 1983~No~RX~HOSPIRA IN
C
A~5GM/100ML;298MG/100ML;450MG/100ML~N~018362~007~AP~Mar 28, 1988~No~RX~HOSPIRA I

NC
TER HEALTHCARE CORP
TER HEALTHCARE CORP
C
C
DEXTROSE; POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 20MEQ IN DE
XTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;149MG/100ML~N~018371~001~~Appro
ved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
ORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~HOSPIRA~
5GM/100ML;149MG/100ML;300MG/100ML~N~018876~002~~Jan 17, 1986~No~RX~HOSPIRA INC
AINER~BAXTER HLTHCARE~1.49GM/100ML~N~019904~006~AP~Dec 17, 1990~Yes~RX~BAXTER HE
ALTHCARE CORP
AINER~BAXTER HLTHCARE~29.8MG/ML~N~019904~002~AP~Dec 26, 1989~Yes~RX~BAXTER HEALT
HCARE CORP
AINER~HOSPIRA~1.49GM/100ML~N~020161~002~AP~Nov 30, 1992~No~RX~HOSPIRA INC
AINER~HOSPIRA~29.8MG/ML~N~020161~006~AP~Aug 11, 1998~Yes~RX~HOSPIRA INC
POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 20ME
Q IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~HOSPIRA~149MG/100ML;900MG/100ML~N
~019686~001~AP~Oct 17, 1988~No~RX~HOSPIRA INC
RA~5GM/100ML;224MG/100ML;225MG/100ML~N~018365~003~~Jul 5, 1983~No~RX~HOSPIRA INC
~5GM/100ML;224MG/100ML;300MG/100ML~N~018876~003~~Jan 17, 1986~No~RX~HOSPIRA INC
A~5GM/100ML;224MG/100ML;450MG/100ML~N~018362~002~AP~Approved Prior to Jan 1, 198
2~No~RX~HOSPIRA INC

TER HEALTHCARE CORP
C
XTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;224MG/100ML~N~018371~003~AP~App
roved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
ALTHCARE CORP
AINER~HOSPIRA~2.24GM/100ML~N~020161~003~AP~Aug 11, 1998~Yes~RX~HOSPIRA INC
RA~5GM/100ML;298MG/100ML;225MG/100ML~N~018365~004~~Jul 5, 1983~No~RX~HOSPIRA INC
A~5GM/100ML;298MG/100ML;450MG/100ML~N~018362~003~AP~Approved Prior to Jan 1, 198
2~No~RX~HOSPIRA INC
TER HEALTHCARE CORP
C
XTROSE 5% IN PLASTIC CONTAINER~HOSPIRA~5GM/100ML;298MG/100ML~N~018371~002~~Appro
ved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
ALTHCARE CORP
AINER~HOSPIRA~2.98GM/100ML~N~020161~004~AP~Aug 11, 1998~Yes~RX~HOSPIRA INC
POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE 40ME
Q IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~HOSPIRA~298MG/100ML;900MG/100ML~N
~019686~002~AP~Oct 17, 1988~No~RX~HOSPIRA INC
INJECTABLE;INJECTION~POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'
S IN PLASTIC CONTAINER~BAXTER HLTHCARE~20MG/100ML;5GM/100ML;105MG/100ML;600MG/10

INJECTABLE;INJECTION~POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'
S IN PLASTIC CONTAINER~HOSPIRA~20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310M
G/100ML~N~019685~001~~Oct 17, 1988~No~DISCN~HOSPIRA INC
A~5GM/100ML;74.5MG/100ML;225MG/100ML~N~018365~005~~Mar 28, 1988~No~RX~HOSPIRA IN
C
A~5GM/100ML;149MG/100ML;225MG/100ML~N~018365~007~~Mar 28, 1988~No~RX~HOSPIRA INC
ORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~HOSPIRA~
5GM/100ML;74.5MG/100ML;300MG/100ML~N~018876~005~~Mar 28, 1988~No~RX~HOSPIRA INC
5GM/100ML;149MG/100ML;300MG/100ML~N~018876~009~~Mar 28, 1988~No~RX~HOSPIRA INC
HLTHCARE~5GM/100ML;150MG/100ML;450MG/100ML~N~018008~004~AP~Approved Prior to Jan
~5GM/100ML;74.5MG/100ML;450MG/100ML~N~018362~008~AP~Mar 28, 1988~No~RX~HOSPIRA I
NC
C
ORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~BAXTER H
LTHCARE~5GM/100ML;150MG/100ML;900MG/100ML~N~019308~001~AP~Apr 5, 1985~No~RX~BAXT
ER HEALTHCARE CORP
5GM/100ML;74.5MG/100ML;900MG/100ML~N~019691~001~AP~Mar 24, 1988~No~RX~HOSPIRA IN
C
5GM/100ML;149MG/100ML;900MG/100ML~N~019691~003~AP~Mar 24, 1988~No~RX~HOSPIRA INC
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE IN PLASTIC CONTAINER~
FRESENIUS KABI USA~2MEQ/ML~A~088901~001~AP~Jan 25, 1985~No~RX~FRESENIUS KABI USA
LLC
POTASSIUM CHLORIDE~INJECTABLE;INJECTION~POTASSIUM CHLORIDE IN PLASTIC CONTAINER~
FRESENIUS KABI USA~2MEQ/ML~A~088908~001~AP~Jan 25, 1985~No~RX~FRESENIUS KABI USA
LLC
PRALIDOXIME CHLORIDE~INJECTABLE;INJECTION~PRALIDOXIME CHLORIDE~BAXTER HLTHCARE C
ORP~300MG/ML~N~018799~001~~Dec 13, 1982~No~DISCN~BAXTER HEALTHCARE CORP ANESTHES
IA CRITICAL CARE
PRALIDOXIME CHLORIDE~INJECTABLE;INJECTION~PRALIDOXIME CHLORIDE~MERIDIAN MEDCL TE
CHN~300MG/ML~N~018986~001~~Apr 26, 1983~Yes~RX~MERIDIAN MEDICAL TECHNOLOGIES INC
BENZYLPENICILLOYL POLYLYSINE~INJECTABLE;INJECTION~PRE-PEN~ALLERQUEST~60UMOLAR~N~
050114~001~~Approved Prior to Jan 1, 1982~Yes~RX~ALLERQUEST LLC
DEXMEDETOMIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~PRECEDEX~HOSPIRA~EQ 80MCG BAS
E/20ML (EQ 4MCG BASE/ML)~N~021038~004~~Nov 14, 2014~No~RX~HOSPIRA INC
DEXMEDETOMIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~PRECEDEX~HOSPIRA~EQ 200MCG BA
SE/2ML (EQ 100MCG BASE/ML)~N~021038~001~AP~Dec 17, 1999~Yes~RX~HOSPIRA INC
SE/50ML (EQ 4MCG BASE/ML)~N~021038~002~~Mar 13, 2013~Yes~RX~HOSPIRA INC
SE/100ML (EQ 4MCG BASE/ML)~N~021038~003~~Mar 13, 2013~Yes~RX~HOSPIRA INC

CEFORANIDE~INJECTABLE;INJECTION~PRECEF~APOTHECON~1GM/VIAL~A~062579~002~~Nov 26,
CEFORANIDE~INJECTABLE;INJECTION~PRECEF~APOTHECON~500MG/VIAL~A~062579~001~~Nov 26
, 1984~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CEFORANIDE~INJECTABLE;INJECTION~PRECEF~BRISTOL~1GM/VIAL~N~050554~002~~May 24, 19
84~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
CEFORANIDE~INJECTABLE;INJECTION~PRECEF~BRISTOL~500MG/VIAL~N~050554~001~~May 24,
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~PREDNISOLONE ACETATE~AKORN~25MG/ML~A~0
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~PREDNISOLONE ACETATE~AKORN~50MG/ML~A~0
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~PREDNISOLONE ACETATE~BEL MAR~25MG/ML~A
~083738~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~PREDNISOLONE ACETATE~BEL MAR~50MG/ML~A
~083738~002~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~PREDNISOLONE ACETATE~CENT PHARMS~25MG/
ML~A~084717~001~~Approved Prior to Jan 1, 1982~No~DISCN~CENTRAL PHARMACEUTICALS
INC
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~PREDNISOLONE ACETATE~CENT PHARMS~50MG/
ML~A~084717~002~~Approved Prior to Jan 1, 1982~No~DISCN~CENTRAL PHARMACEUTICALS
INC
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~PREDNISOLONE ACETATE~WATSON LABS~25MG/
PREDNISOLONE SODIUM PHOSPHATE~INJECTABLE;INJECTION~PREDNISOLONE SODIUM PHOSPHATE
~WATSON LABS~EQ 20MG PHOSPHATE/ML~A~080517~001~~Approved Prior to Jan 1, 1982~No
PREDNISOLONE TEBUTATE~INJECTABLE;INJECTION~PREDNISOLONE TEBUTATE~WATSON LABS~20M
G/ML~A~083362~001~~Feb 17, 1984~No~DISCN~WATSON LABORATORIES INC
GONADOTROPIN, CHORIONIC~INJECTABLE;INJECTION~PREGNYL~ORGANON USA INC~10,000 UNIT
S/VIAL~N~017692~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~ORGANON USA INC
ESTROGENS, CONJUGATED~INJECTABLE;INJECTION~PREMARIN~WYETH PHARMS INC~25MG/VIAL~N
~010402~001~~Approved Prior to Jan 1, 1982~Yes~RX~WYETH PHARMACEUTICALS INC
AMINO ACIDS~INJECTABLE;INJECTION~PREMASOL 10% IN PLASTIC CONTAINER~BAXTER HLTHCA
RE~10% (10GM/100ML)~A~075880~002~~Jun 19, 2003~No~RX~BAXTER HEALTHCARE CORP
AMINO ACIDS~INJECTABLE;INJECTION~PREMASOL 6% IN PLASTIC CONTAINER~BAXTER HLTHCAR
E~6% (6GM/100ML)~A~075880~001~~Jun 19, 2003~No~RX~BAXTER HEALTHCARE CORP
PRILOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PRILOCAINE HYDROCHLORIDE~SEPTODONT
INC~4%~A~079235~001~~Sep 29, 2010~Yes~RX~SEPTODONT INC
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PRILOCAINE

HYDROCHLORIDE AND EPINEPHRINE BITARTRATE~SEPTODONT INC~0.005MG/ML;4%~A~078959~0
01~AP~Aug 30, 2011~No~RX~SEPTODONT INC
MILRINONE LACTATE~INJECTABLE;INJECTION~PRIMACOR~SANOFI AVENTIS US~EQ 1MG BASE/ML
~N~019436~001~~Dec 31, 1987~No~DISCN~SANOFI AVENTIS US LLC
MILRINONE LACTATE~INJECTABLE;INJECTION~PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAI
NER~SANOFI AVENTIS US~EQ 10MG BASE/100ML~N~020343~001~~Aug 9, 1994~No~DISCN~SANO
FI AVENTIS US LLC
NER~SANOFI AVENTIS US~EQ 15MG BASE/100ML~N~020343~002~~Aug 9, 1994~No~DISCN~SANO
FI AVENTIS US LLC
NER~SANOFI AVENTIS US~EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)~N~020343~003~~Aug 9,
1994~No~DISCN~SANOFI AVENTIS US LLC
NER~SANOFI AVENTIS US~EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)~N~020343~004~~Aug 9,
1994~No~DISCN~SANOFI AVENTIS US LLC
CILASTATIN SODIUM; IMIPENEM~INJECTABLE;INJECTION~PRIMAXIN~MERCK~EQ 250MG BASE/VI
AL;250MG/VIAL~A~062756~001~~Jan 8, 1987~No~DISCN~MERCK AND CO INC
CILASTATIN SODIUM; IMIPENEM~INJECTABLE;INJECTION~PRIMAXIN~MERCK~EQ 500MG BASE/VI
AL;500MG/VIAL~A~062756~002~~Jan 8, 1987~No~DISCN~MERCK AND CO INC
TOLAZOLINE HYDROCHLORIDE~INJECTABLE;INJECTION~PRISCOLINE~NOVARTIS~25MG/ML~N~0064
03~005~~Feb 22, 1985~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL B22GK 2/0 IN
PLASTIC CONTAINER~GAMBRO RENAL PRODS~N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM
/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)~N~021703~010~~Oct 10
, 2008~Yes~RX~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL B22GK 2/2.5
IN PLASTIC CONTAINER~GAMBRO RENAL PRODS~3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3
.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)~N~021703~012~~O
ct 10, 2008~No~DISCN~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL B22GK 4/0 IN
PLASTIC CONTAINER~GAMBRO RENAL PRODS~N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM
/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)~N~021703~011~~Oct 10
, 2008~Yes~RX~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL B22GK 4/2.5
IN PLASTIC CONTAINER~GAMBRO RENAL PRODS~3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3
.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)~N~021703~013~~O
ct 10, 2008~Yes~RX~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL BGK 0/2.5 IN
PLASTIC CONTAINER~GAMBRO RENAL PRODS~3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
5GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~006~~Oct 25,
2006~Yes~RX~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL BGK 2/0 IN P
LASTIC CONTAINER~GAMBRO RENAL PRODS~N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1
000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~002~~Oct 25,
3GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~003~~Oct
25, 2006~Yes~RX~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL BGK 4/0 IN P
LASTIC CONTAINER~GAMBRO RENAL PRODS~N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1

000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~005~~Oct 25,
2006~No~DISCN~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL BGK 4/0/1.2
IN PLASTIC CONTAINER~GAMBRO RENAL PRODS~N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44
GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~015~~Oct
25, 2006~No~DISCN~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL BK 0/0 IN PL
ASTIC CONTAINER~GAMBRO RENAL PRODS~N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/100
0ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~007~~Oct 25, 2006~N
o~DISCN~GAMBRO RENAL PRODUCTS
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL BK 0/0/1.2 I
N PLASTIC CONTAINER~GAMBRO RENAL PRODS~N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM
/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~014~~Oct 10, 20
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL BK 0/3.5 IN
PLASTIC CONTAINER~GAMBRO RENAL PRODS~5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03G
M/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~001~~Oct 25, 2
SODIUM BICARBONATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PRISMASOL BK 4/2.5 IN
PLASTIC CONTAINER~GAMBRO RENAL PRODS~3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05G
M/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)~N~021703~009~~Oct 2
5, 2006~No~DISCN~GAMBRO RENAL PRODUCTS
PROPANTHELINE BROMIDE~INJECTABLE;INJECTION~PRO-BANTHINE~GD SEARLE LLC~30MG/VIAL~
N~008843~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~ABRAX
IS PHARM~100MG/ML~A~089415~001~~Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRO
DUCTS
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~ABRAX
IS PHARM~500MG/ML~A~089416~001~~Nov 17, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRO
DUCTS
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~HIKMA
MAPLE ~100MG/ML~A~089029~001~~Apr 17, 1986~No~DISCN~HIKMA MAPLE LTD
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~HIKMA
MAPLE ~500MG/ML~A~089030~001~~Apr 17, 1986~No~DISCN~HIKMA MAPLE LTD
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~HOSPI
RA~100MG/ML~A~089069~001~~Feb 12, 1986~Yes~RX~HOSPIRA INC
RA~500MG/ML~A~089070~001~~Feb 12, 1986~Yes~RX~HOSPIRA INC
RA~500MG/ML~A~089537~001~~Aug 25, 1987~No~DISCN~HOSPIRA INC
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~INTL
MEDICATION~100MG/ML~A~088636~001~~Jul 31, 1984~No~DISCN~INTERNATIONAL MEDICATION
SYSTEM
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~INTL
MEDICATION~500MG/ML~A~088637~001~~Jul 31, 1984~No~DISCN~INTERNATIONAL MEDICATION

SYSTEM
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~PHARM
AFAIR~100MG/ML~A~088824~001~~Nov 20, 1985~No~DISCN~PHARMAFAIR INC
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~PHARM
AFAIR~500MG/ML~A~088830~001~~Nov 20, 1985~No~DISCN~PHARMAFAIR INC
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~SMITH
AND NEPHEW~100MG/ML~A~088530~001~~Mar 4, 1985~No~DISCN~SMITH AND NEPHEW SOLOPAK
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~SMITH
AND NEPHEW~500MG/ML~A~088531~001~~Mar 4, 1985~No~DISCN~SMITH AND NEPHEW SOLOPAK
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~SOLOP
AK~500MG/ML~A~088532~001~~Mar 4, 1985~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~WARNE
R CHILCOTT~100MG/ML~A~089528~001~~May 3, 1988~No~DISCN~WARNER CHILCOTT DIV WARNE
R LAMBERT CO
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~WARNE
R CHILCOTT~500MG/ML~A~089529~001~~May 3, 1988~No~DISCN~WARNER CHILCOTT DIV WARNE
R LAMBERT CO
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~WATSO
N LABS~100MG/ML~A~087079~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABO
RATORIES INC
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINAMIDE HYDROCHLORIDE~WATSO
N LABS~500MG/ML~A~087080~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABO
RATORIES INC
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~ABRAXIS PHARM
~1%~A~080384~002~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEUTICAL
PRODUCTS
PRODUCTS
PRODUCTS
PRODUCTS
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~BEL MAR~1%~A~
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~BEL MAR~2%~A~
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~ELKINS SINN~1
%~A~083315~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS
CO INC
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~ELKINS SINN~2
%~A~083315~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS
CO INC
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~GD SEARLE LLC
~1%~A~086202~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~GD SEARLE LLC
~2%~A~086202~002~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~HOSPIRA~1%~A~
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~HOSPIRA~2%~A~
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~MILES~1%~A~08
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~MILES~2%~A~08
PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE~WATSON LABS~1

%~A~080658~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
EPINEPHRINE; PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE
W/ EPINEPHRINE~BEL MAR~0.02MG/ML;1%~A~080758~001~~Approved Prior to Jan 1, 1982~
No~DISCN~BEL MAR LABORATORIES INC
EPINEPHRINE; PROCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROCAINE HYDROCHLORIDE
W/ EPINEPHRINE~BEL MAR~0.02MG/ML;2%~A~080759~001~~Approved Prior to Jan 1, 1982~
No~DISCN~BEL MAR LABORATORIES INC
AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTA
SSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~PROCALAMINE
~B BRAUN~3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;1
20MG/100ML~N~018582~001~~May 8, 1982~No~RX~B BRAUN MEDICAL INC
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE~BAXTER HLTHCARE
~EQ 5MG BASE/ML~A~087759~001~~Oct 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP ANESTH
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~BEDFO
RD~EQ 5MG BASE/ML~A~040540~001~AP~May 28, 2004~No~RX~BEDFORD LABORATORIES DIV BE
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~EMCUR
E PHARMS LTD~EQ 5MG BASE/ML~A~204147~001~AP~Oct 15, 2013~No~RX~EMCURE PHARMACEUT
ICALS LTD
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~EUROH
LTH INTL SARL~EQ 5MG BASE/ML~A~089903~001~AP~Aug 29, 1989~Yes~RX~EUROHEALTH INTE
RNATIONAL SARL
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~HIKMA
MAPLE ~EQ 5MG BASE/ML~A~089523~001~~May 3, 1988~No~DISCN~HIKMA MAPLE LTD
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~HOSPI
RA~EQ 5MG BASE/ML~A~089703~001~~Apr 7, 1988~No~DISCN~HOSPIRA INC
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~MARSA
M PHARMS LLC~EQ 5MG BASE/ML~A~089675~001~~Dec 5, 1988~No~DISCN~MARSAM PHARMACEUT
ICALS LLC
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~SMITH
AND NEPHEW~EQ 5MG BASE/ML~A~089251~001~~Dec 4, 1986~No~DISCN~SMITH AND NEPHEW S
OLOPAK DIV SMITH AND NEPHEW
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~TEVA
PARENTERAL~EQ 5MG BASE/ML~A~040505~001~~May 30, 2003~No~DISCN~TEVA PARENTERAL ME
DICINES INC
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~WATSO
N LABS~EQ 5MG BASE/ML~A~089530~001~~Jul 8, 1987~No~DISCN~WATSON LABORATORIES INC
PROCHLORPERAZINE EDISYLATE~INJECTABLE;INJECTION~PROCHLORPERAZINE EDISYLATE~WYETH
AYERST~EQ 5MG BASE/ML~A~086348~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYET
IRON DEXTRAN~INJECTABLE;INJECTION~PROFERDEX~NEW RIVER~EQ 50MG IRON/ML~N~017807~0
01~BP~Approved Prior to Jan 1, 1982~No~RX~NEW RIVER PHARMACEUTICALS INC
PROGESTERONE~INJECTABLE;INJECTION~PROGESTERONE~FRESENIUS KABI USA~50MG/ML~A~0759
06~001~AO~Apr 25, 2001~No~RX~FRESENIUS KABI USA LLC
PROGESTERONE~INJECTABLE;INJECTION~PROGESTERONE~HIKMA FARMACEUTICA~50MG/ML~A~0910
33~001~AO~Oct 28, 2010~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
PROGESTERONE~INJECTABLE;INJECTION~PROGESTERONE~LILLY~25MG/ML~N~009238~002~~Appro
PROGESTERONE~INJECTABLE;INJECTION~PROGESTERONE~LILLY~50MG/ML~N~009238~001~~Appro
PROGESTERONE~INJECTABLE;INJECTION~PROGESTERONE~LUITPOLD~50MG/ML~A~090845~001~AO~
Jun 22, 2009~No~RX~LUITPOLD PHARMACEUTICALS INC
PROGESTERONE~INJECTABLE;INJECTION~PROGESTERONE~WATSON LABS (UTAH)~50MG/ML~N~0173
62~002~AO~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
TACROLIMUS~INJECTABLE;INJECTION~PROGRAF~ASTELLAS~EQ 5MG BASE/ML~N~050709~001~~Ap
r 8, 1994~Yes~RX~ASTELLAS PHARMA US INC
GADOTERIDOL~INJECTABLE;INJECTION~PROHANCE~BRACCO~279.3MG/ML~N~020131~001~~Nov 16
, 1992~Yes~RX~BRACCO DIAGNOSTICS INC
GADOTERIDOL~INJECTABLE;INJECTION~PROHANCE MULTIPACK~BRACCO~279.3MG/ML~N~021489~0
01~~Oct 9, 2003~Yes~RX~BRACCO DIAGNOSTICS INC
FLUPHENAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROLIXIN~APOTHECON~2.5MG/ML~N~01
SQUIBB
FLUPHENAZINE DECANOATE~INJECTABLE;INJECTION~PROLIXIN DECANOATE~BRISTOL MYERS SQU
IBB~25MG/ML~N~016727~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS S
QUIBB CO
FLUPHENAZINE ENANTHATE~INJECTABLE;INJECTION~PROLIXIN ENANTHATE~APOTHECON~25MG/ML
~N~016110~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL
MYERS SQUIBB
PROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMAZINE HYDROCHLORIDE~WATSON LABS
S INC
PROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMAZINE HYDROCHLORIDE~WATSON LABS
S INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~ABBOT
T~25MG/ML~A~084223~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORI
ES PHARMACEUTICAL PRODUCTS DIV
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~ABBOT
T~50MG/ML~A~084222~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORI
ES PHARMACEUTICAL PRODUCTS DIV
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~AKORN
~25MG/ML~A~083955~002~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~AKORN
~50MG/ML~A~083955~001~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~BEDFO
RD LABS~25MG/ML~A~040524~001~~Mar 17, 2004~No~DISCN~BEDFORD LABORATORIES
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~BEDFO
RD LABS~50MG/ML~A~040524~002~~Mar 17, 2004~No~DISCN~BEDFORD LABORATORIES
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~HIKMA
MAPLE ~25MG/ML~A~083312~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE
LTD
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~HIKMA
MAPLE ~50MG/ML~A~083312~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE
LTD
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~HOSPI
RA~50MG/ML~A~083838~002~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~LUITP
OLD~25MG/ML~A~040515~001~~Mar 19, 2003~No~DISCN~LUITPOLD PHARMACEUTICALS INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~MARSA
M PHARMS LLC~25MG/ML~A~089463~001~~May 2, 1988~No~DISCN~MARSAM PHARMACEUTICALS L
LC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~MARSA
M PHARMS LLC~50MG/ML~A~089477~001~~May 2, 1988~No~DISCN~MARSAM PHARMACEUTICALS L
LC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~MYLAN
INSTITUTIONAL~25MG/ML~A~040471~001~~Nov 21, 2002~No~DISCN~MYLAN INSTITUTIONAL L
LC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~SANDO
Z~25MG/ML~A~040593~001~~Nov 8, 2006~No~DISCN~SANDOZ INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~SANDO
Z~50MG/ML~A~040593~002~~Nov 8, 2006~No~DISCN~SANDOZ INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~TEVA
PHARMS USA~25MG/ML~A~040454~001~~Aug 22, 2002~No~DISCN~TEVA PHARMACEUTICALS USA
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~TEVA
PHARMS USA~50MG/ML~A~040454~002~~Aug 22, 2002~No~DISCN~TEVA PHARMACEUTICALS USA
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~WATSO
ATORIES INC
ATORIES INC
ATORIES INC
ATORIES INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~WOCKH
ARDT~25MG/ML~A~040785~001~~Sep 26, 2008~No~DISCN~WOCKHARDT LTD
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~WOCKH
ARDT~50MG/ML~A~040785~002~~Sep 26, 2008~No~DISCN~WOCKHARDT LTD
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~X-GEN
PHARMS~25MG/ML~A~040737~001~AP~Apr 24, 2008~No~RX~X-GEN PHARMACEUTICALS INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~PROMETHAZINE HYDROCHLORIDE~X-GEN
PHARMS~50MG/ML~A~040737~002~AP~Apr 24, 2008~No~RX~X-GEN PHARMACEUTICALS INC
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PRONESTYL~APOTHECON~100MG/ML~N~0
S SQUIBB
PROCAINAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~PRONESTYL~APOTHECON~500MG/ML~N~0
S SQUIBB
PROPOFOL~INJECTABLE;INJECTION~PROPOFOL~EUROHLTH INTL SARL~10MG/ML~A~074848~001~~
Apr 19, 2005~No~DISCN~EUROHEALTH INTERNATIONAL SARL
PROPOFOL~INJECTABLE;INJECTION~PROPOFOL~HOSPIRA~10MG/ML~A~077908~001~AB~Mar 17, 2
PROPOFOL~INJECTABLE;INJECTION~PROPOFOL~TEVA PARENTERAL~10MG/ML~A~075392~001~~Sep
19, 2000~No~DISCN~TEVA PARENTERAL MEDICINES INC
PROPOFOL~INJECTABLE;INJECTION~PROPOFOL~TEVA PHARMS USA~10MG/ML~A~075102~001~AB~J
an 4, 1999~No~RX~TEVA PHARMACEUTICALS USA
PROPRANOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~PROPRANOLOL HYDROCHLORIDE~BAXTER
HLTHCARE CORP~1MG/ML~N~016419~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~BAXTER
HEALTHCARE CORP ANESTHESIA CRITICAL CARE
PROPRANOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~PROPRANOLOL HYDROCHLORIDE~BEDFORD
~1MG/ML~A~075792~001~AP~Aug 29, 2000~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LA
BORATORIES INC
PROPRANOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~PROPRANOLOL HYDROCHLORIDE~FRESENI
US KABI USA~1MG/ML~A~075826~001~AP~Aug 31, 2001~No~RX~FRESENIUS KABI USA LLC
PROPRANOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~PROPRANOLOL HYDROCHLORIDE~HIKMA F
ARMACEUTICA~1MG/ML~A~077760~001~AP~Jan 31, 2008~No~RX~HIKMA FARMACEUTICA (PORTUG
AL) SA
PROPRANOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~PROPRANOLOL HYDROCHLORIDE~SANDOZ~
1MG/ML~A~076400~001~AP~Feb 26, 2003~No~RX~SANDOZ CANADA INC
PROPRANOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~PROPRANOLOL HYDROCHLORIDE~SMITH A
ND NEPHEW~1MG/ML~A~070135~001~~Apr 15, 1986~No~DISCN~SMITH AND NEPHEW SOLOPAK DI

V SMITH AND NEPHEW
PROPRANOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~PROPRANOLOL HYDROCHLORIDE~SMITH A
ND NEPHEW~1MG/ML~A~070137~001~~Apr 15, 1986~No~DISCN~SMITH AND NEPHEW SOLOPAK DI
V SMITH AND NEPHEW
PROPRANOLOL HYDROCHLORIDE~INJECTABLE;INJECTION~PROPRANOLOL HYDROCHLORIDE~SOLOPAK
~1MG/ML~A~070136~001~~Apr 15, 1986~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
AMINO ACIDS~INJECTABLE;INJECTION~PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER~BA
XTER HLTHCARE~20% (20GM/100ML)~N~020849~001~~Aug 26, 1998~Yes~RX~BAXTER HEALTHCA
RE INTERNATI0NAL SPECIALTY THERAPIES DIV
DINOPROST TROMETHAMINE~INJECTABLE;INJECTION~PROSTIN F2 ALPHA~PHARMACIA AND UPJOH
N~EQ 5MG BASE/ML~N~017434~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA
AND UPJOHN CO
ALPROSTADIL~INJECTABLE;INJECTION~PROSTIN VR PEDIATRIC~PHARMACIA AND UPJOHN~0.5MG
/ML~N~018484~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
PROTAMINE SULFATE~INJECTABLE;INJECTION~PROTAMINE SULFATE~FRESENIUS KABI USA~10MG
/ML~A~089454~001~~Apr 7, 1987~Yes~RX~FRESENIUS KABI USA LLC
PROTAMINE SULFATE~INJECTABLE;INJECTION~PROTAMINE SULFATE~HIKMA MAPLE ~10MG/ML~A~
089474~001~~Nov 5, 1986~No~DISCN~HIKMA MAPLE LTD
PROTAMINE SULFATE~INJECTABLE;INJECTION~PROTAMINE SULFATE~HIKMA MAPLE ~10MG/ML~A~
089475~001~~Nov 5, 1986~No~DISCN~HIKMA MAPLE LTD
PROTAMINE SULFATE~INJECTABLE;INJECTION~PROTAMINE SULFATE~LILLY~10MG/ML~N~006460~
PROTAMINE SULFATE~INJECTABLE;INJECTION~PROTAMINE SULFATE~PHARMACIA AND UPJOHN~50
MG/VIAL~N~007413~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOH
N CO
PROTAMINE SULFATE~INJECTABLE;INJECTION~PROTAMINE SULFATE~PHARMACIA AND UPJOHN~25
0MG/VIAL~N~007413~002~~Aug 2, 1984~No~DISCN~PHARMACIA AND UPJOHN CO
INSULIN SUSP PROTAMINE ZINC BEEF/PORK~INJECTABLE;INJECTION~PROTAMINE ZINC & ILET
IN I (BEEF-PORK)~LILLY~40 UNITS/ML~N~017932~001~~Approved Prior to Jan 1, 1982~N
o~DISCN~ELI LILLY AND CO
INSULIN SUSP PROTAMINE ZINC BEEF/PORK~INJECTABLE;INJECTION~PROTAMINE ZINC & ILET
IN I (BEEF-PORK)~LILLY~100 UNITS/ML~N~017932~002~~Approved Prior to Jan 1, 1982~
No~DISCN~ELI LILLY AND CO
INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF~INJECTABLE;INJECTION~PROTAMINE ZINC AN
D ILETIN II~LILLY~100 UNITS/ML~N~018476~001~~Approved Prior to Jan 1, 1982~No~DI
SCN~ELI LILLY AND CO
INSULIN SUSP PROTAMINE ZINC PURIFIED PORK~INJECTABLE;INJECTION~PROTAMINE ZINC AN
D ILETIN II (PORK)~LILLY~100 UNITS/ML~N~018346~001~~Approved Prior to Jan 1, 198
INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF~INJECTABLE;INJECTION~PROTAMINE ZINC IN
SULIN~BRISTOL MYERS SQUIBB~40 UNITS/ML~N~017928~001~~Approved Prior to Jan 1, 19
82~No~DISCN~BRISTOL MYERS SQUIBB CO
INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF~INJECTABLE;INJECTION~PROTAMINE ZINC IN
SULIN~BRISTOL MYERS SQUIBB~100 UNITS/ML~N~017928~003~~Approved Prior to Jan 1, 1
PRALIDOXIME CHLORIDE~INJECTABLE;INJECTION~PROTOPAM CHLORIDE~BAXTER HLTHCARE CORP
~1GM/VIAL~N~014134~001~~Approved Prior to Jan 1, 1982~Yes~RX~BAXTER HEALTHCARE C
SOMATREM~INJECTABLE;INJECTION~PROTROPIN~GENENTECH~5MG/VIAL~N~019107~001~~Oct 17,
1985~No~DISCN~GENENTECH INC
SOMATREM~INJECTABLE;INJECTION~PROTROPIN~GENENTECH~10MG/VIAL~N~019107~002~~Oct 24
, 1989~No~DISCN~GENENTECH INC
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT~INJECTABLE;INJECTION~PULMOLITE~JUBILANT
DRAXIMAGE~N/A~N~017776~001~BS~Approved Prior to Jan 1, 1982~No~RX~JUBILANT DRAX
IMAGE INC
CORTICOTROPIN~INJECTABLE;INJECTION~PURIFIED CORTROPHIN GEL~ORGANON USA INC~40 UN
ITS/ML~N~008975~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
CORTICOTROPIN~INJECTABLE;INJECTION~PURIFIED CORTROPHIN GEL~ORGANON USA INC~80 UN
ITS/ML~N~008975~002~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
CARBENICILLIN DISODIUM~INJECTABLE;INJECTION~PYOPEN~GLAXOSMITHKLINE~EQ 1GM BASE/V

IAL~N~050298~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CARBENICILLIN DISODIUM~INJECTABLE;INJECTION~PYOPEN~GLAXOSMITHKLINE~EQ 10GM BASE/
VIAL~N~050298~006~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CARBENICILLIN DISODIUM~INJECTABLE;INJECTION~PYOPEN~GLAXOSMITHKLINE~EQ 20GM BASE/
VIAL~N~050298~007~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CHLORPHENIRAMINE MALEATE~INJECTABLE;INJECTION~PYRIDAMAL 100~BEL MAR~100MG/ML~A~0
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~AKORN~100
MG/ML~A~087967~001~~Oct 1, 1982~No~DISCN~AKORN INC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~BEL MAR~1
00MG/ML~A~080761~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIE
S INC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~DELL LABS
~50MG/ML~A~083771~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES
INC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~DELL LABS
~100MG/ML~A~083772~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES
INC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~ELKINS SI
NN~100MG/ML~A~080581~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV
AH ROBINS CO INC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~FRESENIUS
KABI USA~100MG/ML~A~080618~001~~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS
KABI USA LLC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~LUITPOLD~
100MG/ML~A~080669~001~~Approved Prior to Jan 1, 1982~No~DISCN~LUITPOLD PHARMACEU
TICALS INC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~WATSON LA
RIES INC
PYRIDOXINE HYDROCHLORIDE~INJECTABLE;INJECTION~PYRIDOXINE HYDROCHLORIDE~WATSON LA
RIES INC
TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT~INJECTABLE;INJECTION~PYROLITE~PHAR
MALUCENCE~N/A~N~017684~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMALUCENCE
INC
SAMARIUM SM-153 LEXIDRONAM PENTASODIUM~INJECTABLE;INJECTION~QUADRAMET~LANTHEUS M
EDICAL~50mCi/ML~N~020570~001~~Mar 28, 1997~Yes~RX~LANTHEUS MEDICAL IMAGING INC
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~QUELICIN~HOSPIRA~20MG/ML~N~008845~
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~QUELICIN PRESERVATIVE FREE~HOSPIRA
~20MG/ML~N~008845~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
~50MG/ML~N~008845~002~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
~100MG/ML~N~008845~004~~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
QUINIDINE GLUCONATE~INJECTABLE;INJECTION~QUINIDINE GLUCONATE~LILLY~80MG/ML~N~007
529~002~~Feb 10, 1989~Yes~RX~ELI LILLY AND CO
ARGININE HYDROCHLORIDE~INJECTABLE;INJECTION~R-GENE 10~PHARMACIA AND UPJOHN~10GM/
100ML~N~016931~001~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
ALBUMIN IODINATED I-125 SERUM~INJECTABLE;INJECTION~RADIO-IODINATED (I 125) SERUM
ALBUMIN (HUMAN)~BAYER PHARMS~2.5uCi/AMP~N~017846~001~~Approved Prior to Jan 1,
1982~No~DISCN~BAYER PHARMACEUTICALS CORP
ALBUMIN IODINATED I-125 SERUM~INJECTABLE;INJECTION~RADIOIODINATED SERUM ALBUMIN
(HUMAN) IHSA I 125~MALLINCKRODT~6.67uCi/ML~N~017844~003~~Approved Prior to Jan 1
, 1982~No~DISCN~MALLINCKRODT MEDICAL INC

(HUMAN) IHSA I 125~MALLINCKRODT~10uCi/ML~N~017844~001~~Approved Prior to Jan 1,
1982~No~DISCN~MALLINCKRODT MEDICAL INC
(HUMAN) IHSA I 125~MALLINCKRODT~100uCi/ML~N~017844~002~~Approved Prior to Jan 1,
FIBRINOGEN, I-125~INJECTABLE;INJECTION~RADIONUCLIDE-LABELED (125 I) FIBRINOGEN (
HUMAN) SENSOR~ABBOTT~140uCi/ML~N~017787~001~~Approved Prior to Jan 1, 1982~No~DI
SCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
RANITIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~RANITIDINE HYDROCHLORIDE~BEDFORD~E
Q 25MG BASE/ML~A~074764~001~~Nov 19, 2004~No~DISCN~BEDFORD LABORATORIES DIV BEN
RANITIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~RANITIDINE HYDROCHLORIDE~EUROHLTH
INTL SARL~EQ 25MG BASE/ML~A~074777~001~AP~Mar 2, 2005~No~RX~EUROHEALTH INTERNATI
ONAL SARL
RANITIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~RANITIDINE HYDROCHLORIDE~EUROHLTH
INTL SARL~EQ 25MG BASE/ML~A~077458~001~AP~Feb 16, 2006~No~RX~EUROHEALTH INTERNAT
IONAL SARL
RANITIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~RANITIDINE HYDROCHLORIDE~ZYDUS PHA
RMS USA INC~25MG/ML~A~091534~001~AP~Feb 22, 2013~No~RX~ZYDUS PHARMACEUTICALS USA
INC
RAPACURONIUM BROMIDE~INJECTABLE;INJECTION~RAPLON~ORGANON USA INC~100MG/VIAL~N~02
0984~001~~Aug 18, 1999~No~DISCN~ORGANON USA INC
RAPACURONIUM BROMIDE~INJECTABLE;INJECTION~RAPLON~ORGANON USA INC~200MG/VIAL~N~02
0984~002~~Aug 18, 1999~No~DISCN~ORGANON USA INC
NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE~IN
JECTABLE;INJECTION~RAVOCAINE AND NOVOCAIN W/ LEVOPHED~EASTMAN KODAK~EQ 0.033MG B
ASE/ML;2%;0.4%~N~008592~003~~Approved Prior to Jan 1, 1982~No~DISCN~EASTMAN KODA
K CO
LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE~INJECTABLE;INJ
ECTION~RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN~EASTMAN KODAK~0.05MG/ML;2%;0.4%~N~
008592~007~~Approved Prior to Jan 1, 1982~No~DISCN~EASTMAN KODAK CO
TECHNETIUM TC-99M RED BLOOD CELL KIT~INJECTABLE;INJECTION~RBC-SCAN~CADEMA~N/A~N~
020063~001~~Jun 11, 1992~No~DISCN~CADEMA MEDICAL PRODUCTS INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~REDISOL~MERCK~1MG/ML~N~006668~010~~Approved
Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
LEPIRUDIN RECOMBINANT~INJECTABLE;INJECTION~REFLUDAN~BAYER HLTHCARE~50MG/VIAL~N~0
20807~001~~Mar 6, 1998~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
PHENTOLAMINE MESYLATE~INJECTABLE;INJECTION~REGITINE~NOVARTIS~5MG/VIAL~N~008278~0
03~AP~Approved Prior to Jan 1, 1982~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~REGLAN~BAXTER HLTHCARE CORP~EQ
5MG BASE/ML~N~017862~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~BAXTER HEALTHC
ARE CORP ANESTHESIA CRITICAL CARE
METOCLOPRAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~REGLAN~BAXTER HLTHCARE CORP~EQ
10MG BASE/ML~N~017862~004~~May 28, 1987~No~DISCN~BAXTER HEALTHCARE CORP ANESTHE
SIA CRITICAL CARE
PYRIDOSTIGMINE BROMIDE~INJECTABLE;INJECTION~REGONOL~SANDOZ~5MG/ML~N~017398~001~A
P~Approved Prior to Jan 1, 1982~No~RX~SANDOZ CANADA INC
INSULIN PURIFIED BEEF~INJECTABLE;INJECTION~REGULAR ILETIN II~LILLY~100 UNITS/ML~
N~018478~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
INSULIN PURIFIED PORK~INJECTABLE;INJECTION~REGULAR ILETIN II (PORK)~LILLY~100 UN
ITS/ML~N~018344~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
INSULIN PORK~INJECTABLE;INJECTION~REGULAR INSULIN~NOVO NORDISK INC~100 UNITS/ML~
N~017926~003~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NORDISK INC
INSULIN PURIFIED PORK~INJECTABLE;INJECTION~REGULAR PURIFIED PORK INSULIN~NOVO NO
RDISK INC~100 UNITS/ML~N~018381~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO
NORDISK INC
AMINO ACIDS~INJECTABLE;INJECTION~RENAMIN W/O ELECTROLYTES~BAXTER HLTHCARE~6.5% (
6.5GM/100ML)~N~017493~007~~Oct 15, 1982~No~DISCN~BAXTER HEALTHCARE CORP
DIATRIZOATE MEGLUMINE~INJECTABLE;INJECTION~RENO-60~BRACCO~60%~N~010040~016~~Appr
oved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
DIATRIZOATE MEGLUMINE~INJECTABLE;INJECTION~RENO-DIP~BRACCO~30%~N~010040~012~~App
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~RENOCAL-76~BRACCO
~66%;10%~A~089347~001~~Jun 1, 1988~No~DISCN~BRACCO DIAGNOSTICS INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~RENOGRAFIN-60~BRA
CCO~52%;8%~N~010040~006~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTI
CS INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~RENOGRAFIN-76~BRA
CCO~66%;10%~N~010040~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~BRACCO DIAGNOST
ICS INC
TECHNETIUM TC-99M FERPENTETATE KIT~INJECTABLE;INJECTION~RENOTEC~BRACCO~N/A~N~017
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~RENOVIST~BRACCO~3
4.3%;35%~N~010040~020~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS
INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~INJECTABLE;INJECTION~RENOVIST II~BRACC
O~28.5%;29.1%~N~010040~019~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNO
STICS INC
IODAMIDE MEGLUMINE~INJECTABLE;INJECTION~RENOVUE-65~BRACCO~65%~N~017902~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
IODAMIDE MEGLUMINE~INJECTABLE;INJECTION~RENOVUE-DIP~BRACCO~24%~N~017903~001~~App
MENOTROPINS (FSH;LH)~INJECTABLE;INJECTION~REPRONEX~FERRING~150 IU/VIAL;150 IU/VI
AL~N~021047~002~~Aug 27, 1999~No~DISCN~FERRING PHARMACEUTICALS INC
ZIDOVUDINE~INJECTABLE;INJECTION~RETROVIR~VIIV HLTHCARE~10MG/ML~N~019951~001~AP~F
eb 2, 1990~Yes~RX~VIIV HEALTHCARE CO
EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~REVERSOL~ORGANON USA INC~10MG/ML~A~089
624~001~~May 13, 1988~No~DISCN~ORGANON USA INC
NALMEFENE HYDROCHLORIDE~INJECTABLE;INJECTION~REVEX~BAXTER HLTHCARE CORP~EQ 0.1MG
BASE/ML~N~020459~001~~Apr 17, 1995~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA C
RITICAL CARE
NALMEFENE HYDROCHLORIDE~INJECTABLE;INJECTION~REVEX~BAXTER HLTHCARE CORP~EQ 1MG B
ASE/ML~N~020459~002~~Apr 17, 1995~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA CRI
TICAL CARE
DANTROLENE SODIUM~INJECTABLE;INJECTION~REVONTO~US WORLDMEDS~20MG/VIAL~A~078378~0
01~AP~Jul 24, 2007~No~RX~US WORLDMEDS LLC
RIFAMPIN~INJECTABLE;INJECTION~RIFADIN~SANOFI AVENTIS US~600MG/VIAL~N~050627~001~
AP~May 25, 1989~Yes~RX~SANOFI AVENTIS US LLC
RIFAMPIN~INJECTABLE;INJECTION~RIFAMPIN~AGILA SPECLTS~600MG/VIAL~A~065421~001~AP~
May 22, 2008~No~RX~AGILA SPECIALTIES PRIVATE LTD
RIFAMPIN~INJECTABLE;INJECTION~RIFAMPIN~BEDFORD~600MG/VIAL~A~064217~001~AP~Oct 29
, 1999~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
RIFAMPIN~INJECTABLE;INJECTION~RIFAMPIN~EMCURE PHARMS LTD~600MG/VIAL~A~204101~001
~AP~Aug 18, 2014~No~RX~EMCURE PHARMACEUTICALS LTD
RIFAMPIN~INJECTABLE;INJECTION~RIFAMPIN~FRESENIUS KABI USA~600MG/VIAL~A~091181~00
1~AP~Aug 21, 2014~No~RX~FRESENIUS KABI USA LLC
RIFAMPIN~INJECTABLE;INJECTION~RIFAMPIN~VERSAPHARM INC~600MG/VIAL~A~065502~001~AP
~Sep 21, 2010~No~RX~VERSAPHARM INC
ISONIAZID~INJECTABLE;INJECTION~RIMIFON~ROCHE~25MG/ML~N~008420~002~~Approved Prio
r to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
ISONIAZID~INJECTABLE;INJECTION~RIMIFON~ROCHE~100MG/ML~N~008420~003~~Approved Pri
or to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJECTION~RINGE
R'S IN PLASTIC CONTAINER~B BRAUN~33MG/100ML;30MG/100ML;860MG/100ML~N~018721~001~
~Nov 9, 1982~No~DISCN~B BRAUN MEDICAL INC
R'S IN PLASTIC CONTAINER~B BRAUN~33MG/100ML;30MG/100ML;860MG/100ML~N~020002~001~
AP~Apr 17, 1992~No~RX~B BRAUN MEDICAL INC

R'S IN PLASTIC CONTAINER~BAXTER HLTHCARE~33MG/100ML;30MG/100ML;860MG/100ML~N~016
693~001~AP~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
R'S IN PLASTIC CONTAINER~HOSPIRA~33MG/100ML;30MG/100ML;860MG/100ML~N~018251~001~
AP~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
RITODRINE HYDROCHLORIDE~INJECTABLE;INJECTION~RITODRINE HYDROCHLORIDE~ABRAXIS PHA
RM~10MG/ML~A~071188~001~~Jul 23, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
RITODRINE HYDROCHLORIDE~INJECTABLE;INJECTION~RITODRINE HYDROCHLORIDE~ABRAXIS PHA
RM~15MG/ML~A~071189~001~~Jul 23, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
RITODRINE HYDROCHLORIDE~INJECTABLE;INJECTION~RITODRINE HYDROCHLORIDE~HOSPIRA~10M
G/ML~A~071618~001~~Feb 28, 1991~No~DISCN~HOSPIRA INC
RITODRINE HYDROCHLORIDE~INJECTABLE;INJECTION~RITODRINE HYDROCHLORIDE~HOSPIRA~15M
G/ML~A~071619~001~~Feb 28, 1991~No~DISCN~HOSPIRA INC
RITODRINE HYDROCHLORIDE~INJECTABLE;INJECTION~RITODRINE HYDROCHLORIDE IN DEXTROSE
5% IN PLASTIC CONTAINER~HOSPIRA~30MG/100ML~A~071438~001~~Jan 22, 1991~No~DISCN~
HOSPIRA INC
ROSE BENGAL SODIUM I-131~INJECTABLE;INJECTION~ROBENGATOPE~BRACCO~0.5mCi/VIAL~N~0
ROSE BENGAL SODIUM I-131~INJECTABLE;INJECTION~ROBENGATOPE~BRACCO~1mCi/VIAL~N~016
ROSE BENGAL SODIUM I-131~INJECTABLE;INJECTION~ROBENGATOPE~BRACCO~2mCi/VIAL~N~016
GLYCOPYRROLATE~INJECTABLE;INJECTION~ROBINUL~HIKMA MAPLE ~0.2MG/ML~N~017558~001~A
P~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE LTD
GLYCOPYRROLATE~INJECTABLE;INJECTION~ROBINUL~ROBINS AH~0.2MG/ML~N~014764~001~~App
roved Prior to Jan 1, 1982~No~DISCN~AH ROBINS CO
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~ROCEPHIN~HOFFMANN LA ROCHE~EQ 1GM BASE/V
IAL~A~062654~002~~Apr 30, 1987~No~DISCN~HOFFMANN LA ROCHE INC
IAL~A~063239~003~AP~Aug 13, 1993~Yes~RX~HOFFMANN LA ROCHE INC
IAL~A~062654~003~~Apr 30, 1987~No~DISCN~HOFFMANN LA ROCHE INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~ROCEPHIN~HOFFMANN LA ROCHE~EQ 10GM BASE/
VIAL~N~050585~005~~Dec 21, 1984~No~DISCN~HOFFMANN LA ROCHE INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~ROCEPHIN~HOFFMANN LA ROCHE~EQ 250MG BASE
/VIAL~A~063239~001~~Aug 13, 1993~No~DISCN~HOFFMANN LA ROCHE INC
/VIAL~A~062654~001~~Apr 30, 1987~No~DISCN~HOFFMANN LA ROCHE INC
/VIAL~A~063239~002~AP~Aug 13, 1993~Yes~RX~HOFFMANN LA ROCHE INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~ROCEPHIN~ROCHE~EQ 1GM BASE/VIAL~A~062510
~003~~Mar 12, 1985~No~DISCN~HOFFMANN LA ROCHE INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~ROCEPHIN~ROCHE~EQ 250MG BASE/VIAL~A~0625
10~001~~Mar 12, 1985~No~DISCN~HOFFMANN LA ROCHE INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~ROCEPHIN~ROCHE~EQ 500MG BASE/VIAL~A~0625
10~002~~Mar 12, 1985~No~DISCN~HOFFMANN LA ROCHE INC
CEFTRIAXONE SODIUM; LIDOCAINE~INJECTABLE;INJECTION~ROCEPHIN KIT~HOFFMANN LA ROCH
E~EQ 1GM BASE/VIAL,N/A;N/A,1%~N~050585~006~~May 8, 1996~No~DISCN~HOFFMANN LA ROC
HE INC
CEFTRIAXONE SODIUM; LIDOCAINE~INJECTABLE;INJECTION~ROCEPHIN KIT~HOFFMANN LA ROCH
E~EQ 500MG BASE/VIAL,N/A;N/A,1%~N~050585~007~~May 8, 1996~No~DISCN~HOFFMANN LA R
OCHE INC
CEFTRIAXONE SODIUM~INJECTABLE;INJECTION~ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINE
R~HOFFMANN LA ROCHE~EQ 10MG BASE/ML~N~050624~001~~Feb 11, 1987~No~DISCN~HOFFMANN
LA ROCHE INC
LA ROCHE INC

LA ROCHE INC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~FRESENIUS KABI USA~50
MG/5ML (10MG/ML)~A~078651~001~AP~Dec 29, 2008~No~RX~FRESENIUS KABI USA LLC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~FRESENIUS KABI USA~10
0MG/10ML (10MG/ML)~A~078651~002~AP~Dec 29, 2008~No~RX~FRESENIUS KABI USA LLC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~HOSPIRA~50MG/5ML (10M
G/ML)~A~078519~001~AP~Nov 26, 2008~No~RX~HOSPIRA INC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~HOSPIRA~100MG/10ML (1
0MG/ML)~A~078519~002~AP~Nov 26, 2008~No~RX~HOSPIRA INC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~MYLAN INSTITUTIONAL~5
0MG/5ML (10MG/ML)~A~079199~001~AP~Nov 26, 2008~No~RX~MYLAN INSTITUTIONAL LLC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~MYLAN INSTITUTIONAL~1
00MG/10ML (10MG/ML)~A~079199~002~AP~Nov 26, 2008~No~RX~MYLAN INSTITUTIONAL LLC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~SAGENT STRIDES~50MG/5
ML (10MG/ML)~A~091458~001~AP~Jul 28, 2010~No~RX~SAGENT STRIDES LLC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~SAGENT STRIDES~100MG/
10ML (10MG/ML)~A~091458~002~AP~Jul 28, 2010~No~RX~SAGENT STRIDES LLC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~SANDOZ~50MG/5ML (10MG
/ML)~A~079195~001~AP~Dec 5, 2008~Yes~RX~SANDOZ CANADA INC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~SANDOZ~100MG/10ML (10
MG/ML)~A~079195~002~AP~Dec 5, 2008~Yes~RX~SANDOZ CANADA INC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~TAMARANG~50MG/5ML (10
MG/ML)~A~091115~001~AP~Aug 27, 2012~No~RX~TAMARANG SA
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~TAMARANG~100MG/10ML (
10MG/ML)~A~091115~002~AP~Aug 27, 2012~No~RX~TAMARANG SA
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~TEVA PHARMS~50MG/5ML
(10MG/ML)~A~078717~001~AP~Nov 26, 2008~No~RX~TEVA PHARMACEUTICALS USA
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ROCURONIUM BROMIDE~TEVA PHARMS~100MG/10M
L (10MG/ML)~A~078717~002~AP~Nov 26, 2008~No~RX~TEVA PHARMACEUTICALS USA
FLUMAZENIL~INJECTABLE;INJECTION~ROMAZICON~HOFFMANN LA ROCHE~1MG/10ML (0.1MG/ML)
for safety or efficacy reasons**~N~020073~001~~Dec 20, 1991~No~DISCN~HOFFMANN LA
ROCHE INC
FLUMAZENIL~INJECTABLE;INJECTION~ROMAZICON~HOFFMANN LA ROCHE~0.5MG/5ML (0.1MG/ML)
for safety or efficacy reasons**~N~020073~002~~Dec 20, 1991~No~DISCN~HOFFMANN L
A ROCHE INC
ROPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ROPIVACAINE HYDROCHLORIDE~HOSPIRA
~2MG/ML~A~090194~001~AP~Sep 23, 2014~No~RX~HOSPIRA INC
~7.5MG/ML~A~090194~003~AP~Sep 23, 2014~No~RX~HOSPIRA INC
ROPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ROPIVACAINE HYDROCHLORIDE~NAVINTA
LLC~5MG/ML~A~078601~002~AP~Jul 17, 2014~No~RX~NAVINTA LLC
ROPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ROPIVACAINE HYDROCHLORIDE~NAVINTA
LLC~10MG/ML~A~078601~003~AP~Jul 17, 2014~No~RX~NAVINTA LLC
ROPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~ROPIVACAINE HYDROCHLORIDE~SAGENT
STRIDES~2MG/ML~A~090318~001~AP~Sep 23, 2014~No~RX~SAGENT STRIDES LLC
STRIDES~7.5MG/ML~A~090318~003~AP~Sep 23, 2014~No~RX~SAGENT STRIDES LLC
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~RUBEX~BRISTOL MYERS SQUIBB~10MG/V
IAL~A~062926~001~~Apr 13, 1989~No~DISCN~BRISTOL MYERS SQUIBB CO
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~RUBEX~BRISTOL MYERS SQUIBB~50MG/V

IAL~A~062926~002~~Apr 13, 1989~No~DISCN~BRISTOL MYERS SQUIBB CO
DOXORUBICIN HYDROCHLORIDE~INJECTABLE;INJECTION~RUBEX~BRISTOL MYERS SQUIBB~100MG/
VIAL~A~062926~003~~Apr 13, 1989~No~DISCN~BRISTOL MYERS SQUIBB CO
CYANOCOBALAMIN~INJECTABLE;INJECTION~RUBIVITE~BEL MAR~0.03MG/ML~N~010791~004~~App
roved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~RUBIVITE~BEL MAR~0.1MG/ML~N~010791~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~RUBIVITE~BEL MAR~1MG/ML~N~010791~003~~Approv
ed Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~RUBRAMIN PC~BRISTOL MYERS SQUIBB~0.1MG/ML~N~
006799~002~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
CYANOCOBALAMIN~INJECTABLE;INJECTION~RUBRAMIN PC~BRISTOL MYERS SQUIBB~1MG/ML~N~00
CYANOCOBALAMIN~INJECTABLE;INJECTION~RUBRAMIN PC~BRISTOL MYERS SQUIBB~1MG/ML~N~00
6799~010~~Apr 28, 1988~No~DISCN~BRISTOL MYERS SQUIBB CO
CYANOCOBALAMIN~INJECTABLE;INJECTION~RUVITE~SAVAGE LABS~1MG/ML~A~080570~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~SAIZEN~EMD SERONO~4MG/VIAL~N~019764~
005~~Jan 16, 2007~No~DISCN~EMD SERONO INC
002~BX~Oct 8, 1996~No~RX~EMD SERONO INC
001~~Oct 8, 1996~No~DISCN~EMD SERONO INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~SAIZEN~EMD SERONO~8.8MG/VIAL~N~01976
4~003~~Aug 29, 2000~Yes~RX~EMD SERONO INC
CYCLOSPORINE~INJECTABLE;INJECTION~SANDIMMUNE~NOVARTIS~50MG/ML~N~050573~001~AP~No
v 14, 1983~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~SANDOSTATIN~NOVARTIS~EQ 0.05MG BASE/ML~N
~019667~001~AP~Oct 21, 1988~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~SANDOSTATIN~NOVARTIS~EQ 0.1MG BASE/ML~N~
019667~002~AP~Oct 21, 1988~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
019667~004~AP~Jun 12, 1991~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
019667~003~AP~Oct 21, 1988~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~SANDOSTATIN~NOVARTIS~EQ 1MG BASE/ML~N~01
OCTREOTIDE ACETATE~INJECTABLE;INJECTION~SANDOSTATIN LAR~NOVARTIS~EQ 10MG BASE/VI
AL~N~021008~001~~Nov 25, 1998~No~RX~NOVARTIS PHARMACEUTICALS CORP
AL~N~021008~002~~Nov 25, 1998~No~RX~NOVARTIS PHARMACEUTICALS CORP
AL~N~021008~003~~Nov 25, 1998~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
RESERPINE~INJECTABLE;INJECTION~SANDRIL~LILLY~2.5MG/ML~N~010012~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
SARALASIN ACETATE~INJECTABLE;INJECTION~SARENIN~PROCTER AND GAMBLE~EQ 0.6MG BASE/
ML~N~018009~001~~Approved Prior to Jan 1, 1982~No~DISCN~PROCTER AND GAMBLE PHARM
ACEUTICALS INC SUB PROCTER AND GAMBLE CO
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~SCANDONEST L~DEPRO
CO~0.05MG/ML;2%~A~088388~001~~Oct 10, 1984~Yes~RX~DEPROCO INC
MEPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~SCANDONEST PLAIN~DEPROCO~3%~A~088
387~001~AP~Oct 10, 1984~Yes~RX~DEPROCO INC
IOPAMIDOL~INJECTABLE;INJECTION~SCANLUX-300~SANOCHEMIA CORP USA~61%~A~090394~001~
AP~Jun 18, 2010~No~RX~SANOCHEMIA CORP USA
IOPAMIDOL~INJECTABLE;INJECTION~SCANLUX-370~SANOCHEMIA CORP USA~76%~A~090394~002~
AP~Jun 18, 2010~No~RX~SANOCHEMIA CORP USA

SECOBARBITAL SODIUM~INJECTABLE;INJECTION~SECOBARBITAL SODIUM~ELKINS SINN~100MG/V
IAL~A~083281~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBI
NS CO INC
SECOBARBITAL SODIUM~INJECTABLE;INJECTION~SECOBARBITAL SODIUM~WYETH AYERST~50MG/M
SECOBARBITAL SODIUM~INJECTABLE;INJECTION~SECONAL SODIUM~LILLY~50MG/ML~N~007392~0
SECRETIN~INJECTABLE;INJECTION~SECRETIN-FERRING~FERRING~75CU/VIAL~N~018290~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~FERRING PHARMACEUTICALS INC
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~SEFFIN~GLAXOSMITHKLINE~EQ 1GM BASE/VIAL~
A~062435~001~~Nov 15, 1983~No~DISCN~GLAXOSMITHKLINE
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~SEFFIN~GLAXOSMITHKLINE~EQ 2GM BASE/VIAL~
A~062435~002~~Nov 15, 1983~No~DISCN~GLAXOSMITHKLINE
CEPHALOTHIN SODIUM~INJECTABLE;INJECTION~SEFFIN~GLAXOSMITHKLINE~EQ 10GM BASE/VIAL
~A~062435~003~~Nov 15, 1983~No~DISCN~GLAXOSMITHKLINE
SELENOMETHIONINE SE-75~INJECTABLE;INJECTION~SELENOMETHIONINE SE 75~GE HEALTHCARE
~250uCi/ML~N~017257~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
SELENOMETHIONINE SE-75~INJECTABLE;INJECTION~SELENOMETHIONINE SE 75~MALLINCKRODT~
100uCi/ML~N~017098~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT INC
SELENOMETHIONINE SE-75~INJECTABLE;INJECTION~SELENOMETHIONINE SE 75~PHARMALUCENCE
~500uCi/ML~N~017322~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMALUCENCE IN
C
INSULIN ZINC SUSP PROMPT PURIFIED PORK~INJECTABLE;INJECTION~SEMILENTE~NOVO NORDI
SK INC~100 UNITS/ML~N~018382~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NO
RDISK INC
INSULIN ZINC SUSP PROMPT BEEF~INJECTABLE;INJECTION~SEMILENTE INSULIN~NOVO NORDIS
K INC~100 UNITS/ML~N~017996~003~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NOR
DISK INC
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~SENSORCAI
NE~FRESENIUS KABI USA~0.25%;0.0091MG/ML~A~070966~001~AP~Oct 13, 1987~No~RX~FRESE
NIUS KABI USA LLC
NE~FRESENIUS KABI USA~0.25%;0.0091MG/ML~A~070967~001~AP~Oct 13, 1987~No~RX~FRESE
NIUS KABI USA LLC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;INJECTION~SENSORCAINE~FRESENIUS KABI USA~0.
25%~A~070552~001~AP~May 21, 1986~No~RX~FRESENIUS KABI USA LLC
25%~N~018304~001~AP~Approved Prior to Jan 1, 1982~No~RX~FRESENIUS KABI USA LLC
NE~FRESENIUS KABI USA~0.5%;0.0091MG/ML~A~070968~001~AP~Oct 13, 1987~No~RX~FRESEN
IUS KABI USA LLC
NE~FRESENIUS KABI USA~0.5%;0.0091MG/ML~N~018304~004~AP~Sep 2, 1983~No~RX~FRESENI
US KABI USA LLC
NE~FRESENIUS KABI USA~0.75%;0.0091MG/ML~N~018304~005~AP~Sep 2, 1983~No~RX~FRESEN
IUS KABI USA LLC
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~SEPTOCAINE~
DEPROCO~4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML)~N~022010~001~~Mar 30,
2006~Yes~RX~DEPROCO INC
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE~INJECTABLE;INJECTION~SEPTOCAINE~
DEPROCO~4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)~N~020971~001~AP~Apr 3, 2

000~Yes~RX~DEPROCO INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~INJECTABLE;INJECTION~SEPTRA~MONARCH PHARMS~80MG/M
L;16MG/ML~N~018452~001~~Approved Prior to Jan 1, 1982~No~DISCN~MONARCH PHARMACEU
TICALS INC
MESORIDAZINE BESYLATE~INJECTABLE;INJECTION~SERENTIL~NOVARTIS~EQ 25MG BASE/ML~N~0
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~SEROSTIM~EMD SERONO~4MG/VIAL~N~02060
4~003~BX~Jul 25, 1997~No~RX~EMD SERONO INC
4~002~BX~Aug 23, 1996~No~RX~EMD SERONO INC
4~001~BX~Aug 23, 1996~No~RX~EMD SERONO INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~SEROSTIM~EMD SERONO~8.8MG/VIAL~N~020
RESERPINE~INJECTABLE;INJECTION~SERPASIL~NOVARTIS~2.5MG/ML~N~009434~002~~Approved
Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
SELENOMETHIONINE SE-75~INJECTABLE;INJECTION~SETHOTOPE~BRACCO~85-550uCi/ML~N~0170
SODIUM ACETATE ANHYDROUS~INJECTABLE;INJECTION~SODIUM ACETATE IN PLASTIC CONTAINE
R~HOSPIRA~2MEQ/ML~N~018893~001~~May 4, 1983~Yes~RX~HOSPIRA INC
SODIUM BICARBONATE~INJECTABLE;INJECTION~SODIUM BICARBONATE~HOSPIRA~0.9MEQ/ML~A~0
SODIUM BICARBONATE~INJECTABLE;INJECTION~SODIUM BICARBONATE~HOSPIRA~1MEQ/ML~A~077
SODIUM BICARBONATE~INJECTABLE;INJECTION~SODIUM BICARBONATE IN PLASTIC CONTAINER~
ABBOTT~0.9MEQ/ML~N~019443~001~~Jun 3, 1986~No~DISCN~ABBOTT LABORATORIES PHARMACE
UTICAL PRODUCTS DIV
SODIUM BICARBONATE~INJECTABLE;INJECTION~SODIUM BICARBONATE IN PLASTIC CONTAINER~
ABBOTT~1MEQ/ML~N~019443~002~~Jun 3, 1986~No~DISCN~ABBOTT LABORATORIES PHARMACEUT
ICAL PRODUCTS DIV
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE~ABBOTT~20GM/100ML~N~017013~
RODUCTS DIV
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE~B BRAUN~20GM/100ML~N~017038
~001~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~
B BRAUN~450MG/100ML~N~018184~001~~Approved Prior to Jan 1, 1982~No~DISCN~B BRAUN
MEDICAL INC
B BRAUN~450MG/100ML~N~019635~001~AP~Mar 9, 1988~No~RX~B BRAUN MEDICAL INC
BAXTER HLTHCARE~450MG/100ML~N~018016~001~AP~Approved Prior to Jan 1, 1982~No~RX~
HOSPIRA~450MG/100ML~N~018090~001~AP~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA
INC
HOSPIRA~450MG/100ML~N~019759~001~AP~Jun 8, 1988~No~RX~HOSPIRA INC
MILES~450MG/100ML~N~018503~001~~Approved Prior to Jan 1, 1982~No~DISCN~MILES LAB
ORATORIES INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9%~EUROHLTH INTL SARL~9MG
/ML~A~201850~001~AP~Jan 20, 2012~No~RX~EUROHEALTH INTERNATIONAL SARL
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9%~MEDEFIL INC~18MG/2ML (
9MG/ML)~N~202832~002~~Jan 6, 2012~No~DISCN~MEDEFIL INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9%~MEDEFIL INC~22.5MG/2.5
ML (9MG/ML)~N~202832~003~~Jan 6, 2012~No~DISCN~MEDEFIL INC

SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9%~MEDEFIL INC~90MG/10ML
(9MG/ML)~N~202832~006~~Jan 6, 2012~No~RX~MEDEFIL INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% ~EUROHLTH INTL SARL~9M
G/ML~A~201833~001~~Sep 24, 2013~No~RX~EUROHEALTH INTERNATIONAL SARL
POTASSIUM CHLORIDE; SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% AN
D POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER~B BRAUN~75MG/100ML;900MG/100ML~
N~018722~001~~Nov 9, 1982~No~DISCN~B BRAUN MEDICAL INC
D POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER~BAXTER HLTHCARE~75MG/100ML;900M
G/100ML~N~017648~004~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE C
ORP
D POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER~B BRAUN~300MG/100ML;900MG/100ML~N
~018722~004~~Nov 9, 1982~No~DISCN~B BRAUN MEDICAL INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~A
BBOTT~9MG/ML~N~019218~001~~Jul 13, 1984~No~DISCN~ABBOTT LABORATORIES HOSP PRODUC
TS DIV
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~B
BRAUN~900MG/100ML~N~017464~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~B BRAUN
MEDICAL INC
BRAUN~900MG/100ML~N~019635~002~AP~Mar 9, 1988~Yes~RX~B BRAUN MEDICAL INC
AXTER HLTHCARE~9MG/ML~N~016677~004~AP~Oct 30, 1985~Yes~RX~BAXTER HEALTHCARE CORP
AXTER HLTHCARE~9MG/ML~N~020178~002~AP~Dec 7, 1992~No~RX~BAXTER HEALTHCARE CORP
AXTER HLTHCARE~900MG/100ML~N~016677~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~
AXTER HLTHCARE~900MG/100ML~N~020178~001~AP~Dec 7, 1992~Yes~RX~BAXTER HEALTHCARE
CORP
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~F
RESENIUS KABI USA~9MG/ML~A~088912~001~AP~Jan 10, 1985~Yes~RX~FRESENIUS KABI USA
LLC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~F
RESENIUS MEDCL~900MG/100ML~A~078177~001~AP~Apr 12, 2007~No~RX~FRESENIUS MEDICAL
CARE NORTH AMERICA
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~H
AEMONETICS~900MG/100ML~A~076316~001~AP~Oct 27, 2004~No~RX~HAEMONETICS CORP
OSPIRA~9MG/ML~N~018803~001~AP~Oct 29, 1982~Yes~RX~HOSPIRA INC
OSPIRA~9MG/ML~N~019217~001~AP~Jul 13, 1984~Yes~RX~HOSPIRA INC
OSPIRA~9MG/ML~N~019465~002~AP~Jul 15, 1985~No~RX~HOSPIRA INC
OSPIRA~900MG/100ML~N~016366~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA
INC
OSPIRA~900MG/100ML~N~019465~001~AP~Jul 15, 1985~Yes~RX~HOSPIRA INC
OSPIRA~900MG/100ML~N~019480~001~AP~Sep 17, 1985~Yes~RX~HOSPIRA INC

SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~L
IEBEL-FLARSHEIM~405MG/50ML (9MG/ML)~N~021569~001~~Jul 27, 2006~Yes~RX~LIEBEL-FLA
RSHEIM CO LLC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~L
IEBEL-FLARSHEIM~1012.5MG/125ML (9MG/ML)~N~021569~002~~Jul 27, 2006~No~RX~LIEBELFLARSHEIM CO LLC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~M
EDEFIL INC~9MG/ML (9MG/ML)~N~202832~001~~Jan 6, 2012~No~DISCN~MEDEFIL INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~M
ILES~900MG/100ML~N~018502~001~~Approved Prior to Jan 1, 1982~No~DISCN~MILES LABO
RATORIES INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~T
ARO PHARMS IRELAND~9MG/ML~A~077407~001~AP~Aug 11, 2006~Yes~RX~TARO PHARMACEUTICA
LS IRELAND LTD
ABRAXIS PHARM~234MG/ML~N~019329~001~~Apr 22, 1987~No~DISCN~ABRAXIS PHARMACEUTICA
L PRODUCTS
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 3% IN PLASTIC CONTAINER~B B
RAUN~3GM/100ML~N~019635~003~~Mar 9, 1988~No~DISCN~B BRAUN MEDICAL INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 3% IN PLASTIC CONTAINER~BAX
TER HLTHCARE~3GM/100ML~N~019022~001~~Nov 1, 1983~No~RX~BAXTER HEALTHCARE CORP
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 5% IN PLASTIC CONTAINER~B B
RAUN~5GM/100ML~N~019635~004~~Mar 9, 1988~No~DISCN~B BRAUN MEDICAL INC
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE 5% IN PLASTIC CONTAINER~BAX
TER HLTHCARE~5GM/100ML~N~019022~002~~Nov 1, 1983~No~RX~BAXTER HEALTHCARE CORP
SODIUM CHLORIDE~INJECTABLE;INJECTION~SODIUM CHLORIDE IN PLASTIC CONTAINER~HOSPIR
A~2.5MEQ/ML~N~018897~001~~Jul 20, 1984~No~RX~HOSPIRA INC
SODIUM CHROMATE CR-51~INJECTABLE;INJECTION~SODIUM CHROMATE CR 51~MALLINCKRODT~10
0uCi/ML~N~016708~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICA
L INC
SODIUM FERRIC GLUCONATE COMPLEX~INJECTABLE;INJECTION~SODIUM FERRIC GLUCONATE COM
PLEX IN SUCROSE~HIKMA PHARMS~62.5MG/5ML~A~078215~001~AB~Mar 31, 2011~No~RX~HIKMA
PHARMACEUTICALS LLC
HEPARIN SODIUM~INJECTABLE;INJECTION~SODIUM HEPARIN~ABRAXIS PHARM~5,000 UNITS/ML~
UCTS
HEPARIN SODIUM~INJECTABLE;INJECTION~SODIUM HEPARIN~ABRAXIS PHARM~10,000 UNITS/ML
DUCTS
HEPARIN SODIUM~INJECTABLE;INJECTION~SODIUM HEPARIN~ABRAXIS PHARM~20,000 UNITS/ML
DUCTS
HEPARIN SODIUM~INJECTABLE;INJECTION~SODIUM HEPARIN~BAXTER HLTHCARE~1,000 UNITS/M
L~N~017036~001~~Mar 4, 1988~No~DISCN~BAXTER HEALTHCARE CORP
SODIUM LACTATE~INJECTABLE;INJECTION~SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAI
NER~B BRAUN~1.87GM/100ML~N~018186~001~~Approved Prior to Jan 1, 1982~No~DISCN~B
BRAUN MEDICAL INC
NER~BAXTER HLTHCARE~1.87GM/100ML~N~016692~001~AP~Approved Prior to Jan 1, 1982~N
o~RX~BAXTER HEALTHCARE CORP
NER~HOSPIRA~1.87GM/100ML~N~018249~001~~Approved Prior to Jan 1, 1982~No~DISCN~HO
SPIRA INC
SODIUM LACTATE~INJECTABLE;INJECTION~SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINE
R~B BRAUN~1.87GM/100ML~N~020004~001~AP~Apr 21, 1992~No~RX~B BRAUN MEDICAL INC
SODIUM LACTATE~INJECTABLE;INJECTION~SODIUM LACTATE IN PLASTIC CONTAINER~HOSPIRA~
5MEQ/ML~N~018947~001~~Sep 5, 1984~Yes~RX~HOSPIRA INC
SODIUM NITROPRUSSIDE~INJECTABLE;INJECTION~SODIUM NITROPRUSSIDE~ABRAXIS PHARM~50M
G/VIAL~A~070031~001~~Jan 17, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
SODIUM NITROPRUSSIDE~INJECTABLE;INJECTION~SODIUM NITROPRUSSIDE~BAXTER HLTHCARE~5

0MG/VIAL~N~018581~001~~Jul 28, 1982~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA A
ND CRITICAL CARE
SODIUM NITROPRUSSIDE~INJECTABLE;INJECTION~SODIUM NITROPRUSSIDE~TEVA PARENTERAL~2
5MG/ML~A~073465~001~~Mar 30, 1992~No~DISCN~TEVA PARENTERAL MEDICINES INC
PENTOBARBITAL SODIUM~INJECTABLE;INJECTION~SODIUM PENTOBARBITAL~WYETH AYERST~50MG
/ML~A~083261~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORI
ES
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS~
INJECTABLE;INJECTION~SODIUM PHOSPHATES IN PLASTIC CONTAINER~HOSPIRA~142MG/ML;276
MG/ML~N~018892~001~~May 10, 1983~Yes~RX~HOSPIRA INC
TECHNETIUM TC-99M POLYPHOSPHATE KIT~INJECTABLE;INJECTION~SODIUM POLYPHOSPHATE-TI
N KIT~GE HEALTHCARE~N/A~N~017664~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE
HEALTHCARE
ROSE BENGAL SODIUM I-131~INJECTABLE;INJECTION~SODIUM ROSE BENGAL I 131~SORIN~0.5
mCi/ML~N~017318~001~~Approved Prior to Jan 1, 1982~No~DISCN~SORIN BIOMEDICA SPA
SODIUM SUCCINATE~INJECTABLE;INJECTION~SODIUM SUCCINATE~ELKINS SINN~30%~A~080516~
SODIUM THIOSULFATE~INJECTABLE;INJECTION~SODIUM THIOSULFATE~US ARMY~250MG/ML~N~02
0166~001~~Feb 14, 1992~No~DISCN~UNITED STATES ARMY OFFICE SURGEON GENERAL
HYDROCORTISONE SODIUM SUCCINATE~INJECTABLE;INJECTION~SOLU-CORTEF~PHARMACIA AND U
PJOHN~EQ 1GM BASE/VIAL~N~009866~004~AP~Approved Prior to Jan 1, 1982~Yes~RX~PHAR
MACIA AND UPJOHN CO
PJOHN~EQ 100MG BASE/VIAL~N~009866~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~PH
ARMACIA AND UPJOHN CO
METHYLPREDNISOLONE SODIUM SUCCINATE~INJECTABLE;INJECTION~SOLU-MEDROL~PHARMACIA A
ND UPJOHN~EQ 1GM BASE/VIAL~N~011856~006~AP~Approved Prior to Jan 1, 1982~Yes~RX~
PHARMACIA AND UPJOHN CO
ND UPJOHN~EQ 2GM BASE/VIAL~N~011856~007~AP~Feb 27, 1985~Yes~RX~PHARMACIA AND UPJ
OHN CO
ND UPJOHN~EQ 40MG BASE/VIAL~N~011856~003~AP~Approved Prior to Jan 1, 1982~Yes~RX
~PHARMACIA AND UPJOHN CO
ND UPJOHN~EQ 125MG BASE/VIAL~N~011856~004~AP~Approved Prior to Jan 1, 1982~Yes~R
X~PHARMACIA AND UPJOHN CO
ND UPJOHN~EQ 500MG BASE/VIAL~N~011856~005~AP~Approved Prior to Jan 1, 1982~Yes~R
X~PHARMACIA AND UPJOHN CO
SODIUM TETRADECYL SULFATE~INJECTABLE;INJECTION~SOTRADECOL~ELKINS SINN~1% **Feder
LKINS SINN DIV AH ROBINS CO INC
SODIUM TETRADECYL SULFATE~INJECTABLE;INJECTION~SOTRADECOL~ELKINS SINN~3% **Feder
LKINS SINN DIV AH ROBINS CO INC
SODIUM TETRADECYL SULFATE~INJECTABLE;INJECTION~SOTRADECOL~MYLAN INSTITUTIONAL~20
MG/2ML (10MG/ML)~A~040541~001~~Nov 12, 2004~No~RX~MYLAN INSTITUTIONAL LLC
SODIUM TETRADECYL SULFATE~INJECTABLE;INJECTION~SOTRADECOL~MYLAN INSTITUTIONAL~60
MG/2ML (30MG/ML)~A~040541~002~~Nov 12, 2004~Yes~RX~MYLAN INSTITUTIONAL LLC
SOYBEAN OIL~INJECTABLE;INJECTION~SOYACAL 10%~ALPHA THERA~10%~N~018465~001~~Jun 2
9, 1983~No~DISCN~ALPHA THERAPEUTIC CORP

SOYBEAN OIL~INJECTABLE;INJECTION~SOYACAL 20%~ALPHA THERA~20%~N~018786~001~~Jun 2
9, 1983~No~DISCN~ALPHA THERAPEUTIC CORP
PROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~SPARINE~BAXTER HLTHCARE CORP~25MG/M
L~N~010349~008~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP AN
ESTHESIA CRITICAL CARE
PROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~SPARINE~BAXTER HLTHCARE CORP~50MG/M
L~N~010349~006~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP AN
ESTHESIA CRITICAL CARE
IOFETAMINE HYDROCHLORIDE I-123~INJECTABLE;INJECTION~SPECTAMINE~IMP~1mCi/ML~N~019
432~001~~Dec 24, 1987~No~DISCN~IMP INC
ITRACONAZOLE~INJECTABLE;INJECTION~SPORANOX~JANSSEN PHARMS~10MG/ML~N~020966~001~~
Mar 30, 1999~No~DISCN~JANSSEN PHARMACEUTICALS INC
BUTORPHANOL TARTRATE~INJECTABLE;INJECTION~STADOL~APOTHECON~2MG/ML~N~017857~004~~
BUTORPHANOL TARTRATE~INJECTABLE;INJECTION~STADOL PRESERVATIVE FREE~APOTHECON~1MG
/ML~N~017857~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRIST
OL MYERS SQUIBB
BUTORPHANOL TARTRATE~INJECTABLE;INJECTION~STADOL PRESERVATIVE FREE~APOTHECON~2MG
/ML~N~017857~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRIST
OL MYERS SQUIBB
METHICILLIN SODIUM~INJECTABLE;INJECTION~STAPHCILLIN~APOTHECON~EQ 3.6GM BASE/VIAL
~A~061449~002~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL
MYERS SQUIBB
MYERS SQUIBB
MYERS SQUIBB
MYERS SQUIBB
METHICILLIN SODIUM~INJECTABLE;INJECTION~STAPHCILLIN~APOTHECON~EQ 900MG BASE/VIAL
MYERS SQUIBB
METHICILLIN SODIUM~INJECTABLE;INJECTION~STAPHCILLIN~APOTHECON~EQ 900MG BASE/VIAL
MYERS SQUIBB
TRIFLUOPERAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~STELAZINE~GLAXOSMITHKLINE~EQ
2MG BASE/ML~N~011552~005~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
PREDNISOLONE ACETATE~INJECTABLE;INJECTION~STERANE~PFIZER~25MG/ML~N~011446~001~~A
UREA~INJECTABLE;INJECTION~STERILE UREA~HOSPIRA~40GM/VIAL~N~017698~001~~Approved
Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
DIETHYLSTILBESTROL~INJECTABLE;INJECTION~STILBESTROL~BRISTOL MYERS SQUIBB~0.2MG/M
L~N~004056~003~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
DIETHYLSTILBESTROL~INJECTABLE;INJECTION~STILBESTROL~BRISTOL MYERS SQUIBB~0.5MG/M
L~N~004056~004~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
DIETHYLSTILBESTROL~INJECTABLE;INJECTION~STILBESTROL~BRISTOL MYERS SQUIBB~1MG/ML~
N~004056~005~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
DIETHYLSTILBESTROL~INJECTABLE;INJECTION~STILBESTROL~BRISTOL MYERS SQUIBB~5MG/ML~
N~004056~006~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
DIETHYLSTILBESTROL DIPHOSPHATE~INJECTABLE;INJECTION~STILPHOSTROL~BAYER PHARMS~25
0MG/5ML~N~010010~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICA
LS CORP
STREPTOMYCIN SULFATE~INJECTABLE;INJECTION~STREPTOMYCIN SULFATE~COPANOS~EQ 500MG
BASE/ML~A~060684~001~~Approved Prior to Jan 1, 1982~No~DISCN~JOHN D COPANOS AND
CO INC
STREPTOMYCIN SULFATE~INJECTABLE;INJECTION~STREPTOMYCIN SULFATE~LILLY~EQ 1GM BASE
/VIAL~A~060107~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO

/2ML~A~060404~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
/VIAL~A~060107~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
STREPTOMYCIN SULFATE~INJECTABLE;INJECTION~STREPTOMYCIN SULFATE~PFIZER~EQ 1GM BAS
E/VIAL~A~060076~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES
DIV PFIZER INC
E/2.5ML~A~060111~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES
DIV PFIZER INC
E/VIAL~A~060076~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES
DIV PFIZER INC
STREPTOMYCIN SULFATE~INJECTABLE;INJECTION~STREPTOMYCIN SULFATE~X GEN PHARMS~EQ 1
GM BASE/VIAL~A~064210~001~~Jun 30, 1998~Yes~RX~X GEN PHARMACEUTICALS INC
STRONTIUM CHLORIDE SR-89~INJECTABLE;INJECTION~STRONTIUM CHLORIDE SR-89~BIO NUCLE
ONICS~1mCi/ML~A~075941~001~AP~Jan 6, 2003~No~RX~BIO NUCLEONICS INC
FENTANYL CITRATE~INJECTABLE;INJECTION~SUBLIMAZE PRESERVATIVE FREE~AKORN~EQ 0.05M
G BASE/ML~N~016619~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~AKORN INC
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~SUCCINYLCHOLINE CHLORIDE~INTL MEDI
CATION~100MG/VIAL~A~085400~001~~Feb 4, 1982~No~DISCN~INTERNATIONAL MEDICATION SY
STEMS LTD
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~SUCCINYLCHOLINE CHLORIDE~ORGANON U
SA INC~20MG/ML~A~080997~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA
INC
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~SUCOSTRIN~APOTHECON~20MG/ML~N~0088
QUIBB
SUCCINYLCHOLINE CHLORIDE~INJECTABLE;INJECTION~SUCOSTRIN~APOTHECON~100MG/ML~N~008
SQUIBB
SUFENTANIL CITRATE~INJECTABLE;INJECTION~SUFENTA PRESERVATIVE FREE~AKORN~EQ 0.05M
G BASE/ML~N~019050~001~AP~May 4, 1984~Yes~RX~AKORN INC
SUFENTANIL CITRATE~INJECTABLE;INJECTION~SUFENTANIL CITRATE~HIKMA MAPLE ~EQ 0.05M
G BASE/ML~A~074413~001~AP~Dec 15, 1995~No~RX~HIKMA MAPLE LTD
SUFENTANIL CITRATE~INJECTABLE;INJECTION~SUFENTANIL CITRATE~HOSPIRA~EQ 0.05MG BAS
E/ML~A~074534~001~AP~Dec 11, 1996~No~RX~HOSPIRA INC
SUFENTANIL CITRATE~INJECTABLE;INJECTION~SUFENTANIL CITRATE~WATSON LABS~EQ 0.05MG
BASE/ML~A~074406~001~~Dec 15, 1995~No~DISCN~WATSON LABORATORIES INC
SULFADIAZINE SODIUM~INJECTABLE;INJECTION~SULFADIAZINE SODIUM~LEDERLE~250MG/ML~N~
ICAN CYANAMID CO
SULFAMETHOXAZOLE; TRIMETHOPRIM~INJECTABLE;INJECTION~SULFAMETHOXAZOLE AND TRIMETH
OPRIM~ABRAXIS PHARM~80MG/ML;16MG/ML~A~070223~001~~Dec 29, 1987~No~DISCN~ABRAXIS
OPRIM~BEDFORD~80MG/ML;16MG/ML~A~072383~001~~Apr 29, 1992~No~DISCN~BEDFORD LABORA
TORIES DIV BEN VENUE LABORATORIES INC
OPRIM~HIKMA MAPLE ~80MG/ML;16MG/ML~A~070627~001~~Dec 29, 1987~No~DISCN~HIKMA MAP
LE LTD
OPRIM~HIKMA MAPLE ~80MG/ML;16MG/ML~A~070628~001~~Dec 29, 1987~No~DISCN~HIKMA MAP
LE LTD
OPRIM~HOSPIRA~80MG/ML;16MG/ML~A~073199~001~~Sep 11, 1992~No~DISCN~HOSPIRA INC
OPRIM~TEVA PHARMS USA~80MG/ML;16MG/ML~A~073303~001~~Oct 31, 1991~Yes~RX~TEVA PHA
RMACEUTICALS USA

OPRIM~WATSON LABS~80MG/ML;16MG/ML~A~071556~001~~Dec 29, 1987~No~DISCN~WATSON LAB
ORATORIES INC
HISTRELIN ACETATE~INJECTABLE;INJECTION~SUPPRELIN~SHIRE~EQ 0.2MG BASE/ML~N~019836
~001~~Dec 24, 1991~No~DISCN~SHIRE DEVELOPMENT INC
HISTRELIN ACETATE~INJECTABLE;INJECTION~SUPPRELIN~SHIRE~EQ 0.5MG BASE/ML~N~019836
~002~~Dec 24, 1991~No~DISCN~SHIRE DEVELOPMENT INC
HISTRELIN ACETATE~INJECTABLE;INJECTION~SUPPRELIN~SHIRE~EQ 1MG BASE/ML~N~019836~0
03~~Dec 24, 1991~No~DISCN~SHIRE DEVELOPMENT INC
THIAMYLAL SODIUM~INJECTABLE;INJECTION~SURITAL~PARKEDALE~1GM/VIAL~N~007600~003~~A
THIAMYLAL SODIUM~INJECTABLE;INJECTION~SURITAL~PARKEDALE~5GM/VIAL~N~007600~005~~A
THIAMYLAL SODIUM~INJECTABLE;INJECTION~SURITAL~PARKEDALE~10GM/VIAL~N~007600~009~~
Approved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
EPINEPHRINE~INJECTABLE;INJECTION~SUS-PHRINE SULFITE-FREE~FOREST LABS~1.5MG/AMP~N
~007942~003~~Feb 5, 1999~No~DISCN~FOREST LABORATORIES INC
EPINEPHRINE~INJECTABLE;INJECTION~SUS-PHRINE SULFITE-FREE~FOREST LABS~5MG/ML~N~00
7942~001~~Approved Prior to Jan 1, 1982~No~DISCN~FOREST LABORATORIES INC
DECAMETHONIUM BROMIDE~INJECTABLE;INJECTION~SYNCURINE~GLAXOSMITHKLINE~1MG/ML~N~00
MENADIOL SODIUM DIPHOSPHATE~INJECTABLE;INJECTION~SYNKAYVITE~ROCHE~5MG/ML~N~00371
MENADIOL SODIUM DIPHOSPHATE~INJECTABLE;INJECTION~SYNKAYVITE~ROCHE~10MG/ML~N~0037
MENADIOL SODIUM DIPHOSPHATE~INJECTABLE;INJECTION~SYNKAYVITE~ROCHE~37.5MG/ML~N~00
OXYTOCIN~INJECTABLE;INJECTION~SYNTOCINON~NOVARTIS~10USP UNITS/ML~N~018245~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
CIMETIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~TAGAMET~GLAXOSMITHKLINE~EQ 300MG B
ASE/2ML~N~017939~002~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CIMETIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~TAGAMET HYDROCHLORIDE IN SODIUM CH
LORIDE 0.9% IN PLASTIC CONTAINER~GLAXOSMITHKLINE~EQ 6MG BASE/ML~N~019434~001~~Oc
t 31, 1985~No~DISCN~GLAXOSMITHKLINE
PENTAZOCINE LACTATE~INJECTABLE;INJECTION~TALWIN~HOSPIRA~EQ 30MG BASE/ML~N~016194
~001~~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
CHLORPROTHIXENE~INJECTABLE;INJECTION~TARACTAN~ROCHE~12.5MG/ML~N~012487~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
PACLITAXEL~INJECTABLE;INJECTION~TAXOL~HQ SPCLT PHARMA~6MG/ML~N~020262~001~AP~Dec
29, 1992~No~RX~HQ SPECIALTY PHARMA CORP
DOCETAXEL~INJECTABLE;INJECTION~TAXOTERE~SANOFI AVENTIS US~20MG/ML (20MG/ML)~N~02
0449~003~AP~Aug 3, 2010~Yes~RX~SANOFI AVENTIS US LLC
DOCETAXEL~INJECTABLE;INJECTION~TAXOTERE~SANOFI AVENTIS US~40MG/ML **Federal Regi
ster determination that product was not discontinued or withdrawn for safety or
efficacy reasons**~N~020449~001~~May 14, 1996~No~DISCN~SANOFI AVENTIS US LLC
DOCETAXEL~INJECTABLE;INJECTION~TAXOTERE~SANOFI AVENTIS US~80MG/4ML (20MG/ML)~N~0
20449~004~AP~Aug 2, 2010~Yes~RX~SANOFI AVENTIS US LLC
DOCETAXEL~INJECTABLE;INJECTION~TAXOTERE~SANOFI AVENTIS US~160MG/8ML (20MG/ML)~N~
020449~005~AP~Apr 13, 2012~Yes~RX~SANOFI AVENTIS US LLC
CEFTAZIDIME~INJECTABLE;INJECTION~TAZICEF~HOSPIRA~1GM/VIAL~A~062662~002~AP~Mar 6,
CEFTAZIDIME~INJECTABLE;INJECTION~TAZICEF~HOSPIRA~1GM/VIAL~A~064032~001~AP~Oct 31
, 1993~No~RX~HOSPIRA INC
CEFTAZIDIME~INJECTABLE;INJECTION~TAZICEF~HOSPIRA~2GM/VIAL~A~064032~002~AP~Oct 31
, 1993~No~RX~HOSPIRA INC
CEFTAZIDIME~INJECTABLE;INJECTION~TAZICEF~HOSPIRA~500MG/VIAL~A~062662~001~AP~Mar
CEFTAZIDIME~INJECTABLE;INJECTION~TAZIDIME~LILLY~1GM/VIAL~A~062655~001~~Nov 20, 1
CEFTAZIDIME~INJECTABLE;INJECTION~TAZIDIME~LILLY~2GM/VIAL~A~062655~002~~Nov 20, 1
CEFTAZIDIME~INJECTABLE;INJECTION~TAZIDIME IN PLASTIC CONTAINER~LILLY~1GM/VIAL~A~
062739~001~~Jul 10, 1986~No~DISCN~ELI LILLY AND CO
CEFTAZIDIME~INJECTABLE;INJECTION~TAZIDIME IN PLASTIC CONTAINER~LILLY~2GM/VIAL~A~
062739~002~~Jul 10, 1986~No~DISCN~ELI LILLY AND CO
TECHNETIUM TC-99M ALBUMIN AGGREGATED~INJECTABLE;INJECTION~TC 99M-LUNGAGGREGATE~G
E HEALTHCARE~5mCi/ML~N~017848~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEA
LTHCARE
TECHNETIUM TC-99M OXIDRONATE KIT~INJECTABLE;INJECTION~TECHNESCAN~MALLINCKRODT~N/
A~N~018321~001~~Approved Prior to Jan 1, 1982~Yes~RX~MALLINCKRODT MEDICAL INC
TECHNETIUM TC-99M GLUCEPTATE KIT~INJECTABLE;INJECTION~TECHNESCAN GLUCEPTATE~DRAX
IMAGE~N/A~N~018272~001~~Jan 27, 1982~No~DISCN~DRAXIMAGE INC
TECHNETIUM TC-99M LIDOFENIN KIT~INJECTABLE;INJECTION~TECHNESCAN HIDA~DRAXIMAGE~N
/A~N~018489~001~~Oct 31, 1986~No~DISCN~DRAXIMAGE INC
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT~INJECTABLE;INJECTION~TECHNESCAN MAA~MAL
LINCKRODT~N/A~N~017842~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT
MEDICAL INC
TECHNETIUM TC-99M MERTIATIDE KIT~INJECTABLE;INJECTION~TECHNESCAN MAG3~MALLINCKRO
DT~N/A~N~019882~001~~Jun 15, 1990~Yes~RX~MALLINCKRODT MEDICAL INC
TECHNETIUM TC-99M PYROPHOSPHATE KIT~INJECTABLE;INJECTION~TECHNESCAN PYP KIT~MALL
INCKRODT~N/A~N~017538~001~AP~Approved Prior to Jan 1, 1982~No~RX~MALLINCKRODT ME
DICAL INC
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT~INJECTABLE;INJECTION~TECHNETIUM TC 99M
ALBUMIN AGGREGATED KIT~DRAXIMAGE~N/A~N~017881~001~BS~Dec 30, 1987~No~RX~DRAXIMAG
E INC
TECHNETIUM TC-99M ETIDRONATE KIT~INJECTABLE;INJECTION~TECHNETIUM TC 99M DIPHOSPH
ONATE-TIN KIT~GE HEALTHCARE~N/A~N~017562~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~GE HEALTHCARE
TECHNETIUM TC-99M ALBUMIN KIT~INJECTABLE;INJECTION~TECHNETIUM TC 99M HSA~GE HEAL
THCARE~N/A~N~017775~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT~INJECTABLE;INJECTION~TECHNETIUM TC 99M
MAA~GE HEALTHCARE~N/A~N~017773~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HE
ALTHCARE
TECHNETIUM TC-99M MEDRONATE KIT~INJECTABLE;INJECTION~TECHNETIUM TC 99M MPI MDP~G
E HEALTHCARE~N/A~N~018141~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHC
ARE
TECHNETIUM TC-99M MEDRONATE KIT~INJECTABLE;INJECTION~TECHNETIUM TC 99M MPI MDP~G
E HEALTHCARE~N/A~N~018141~002~~Jun 12, 1989~No~DISCN~GE HEALTHCARE
TECHNETIUM TC-99M SESTAMIBI KIT~INJECTABLE;INJECTION~TECHNETIUM TC 99M SESTAMIBI
~CARDINAL HEALTH 414~N/A~A~078809~001~AP~Apr 28, 2009~No~RX~CARDINAL HEALTH 414
LLC
~DRAXIMAGE~N/A~A~078806~001~AP~Apr 29, 2009~No~RX~DRAXIMAGE INC
~PHARMALUCENCE~10-30mCi~A~079157~001~AP~Jul 10, 2009~No~RX~PHARMALUCENCE INC
TECHNETIUM TC-99M MEBROFENIN KIT~INJECTABLE;INJECTION~TECHNETIUM TC-99M MEBROFEN
IN~PHARMALUCENCE~N/A~A~078242~001~AP~Jan 29, 2008~No~RX~PHARMALUCENCE INC
TECHNETIUM TC-99M PENTETATE KIT~INJECTABLE;INJECTION~TECHNETIUM TC-99M PENTETATE
KIT~GE HEALTHCARE~N/A~N~017264~002~~Approved Prior to Jan 1, 1982~No~DISCN~GE H
EALTHCARE
TECHNETIUM TC-99M SESTAMIBI KIT~INJECTABLE;INJECTION~TECHNETIUM TC-99M SESTAMIBI
~MALLINCKRODT~N/A~A~078098~001~AP~Sep 22, 2008~No~RX~MALLINCKRODT INC
ATENOLOL~INJECTABLE;INJECTION~TENORMIN~ASTRAZENECA~0.5MG/ML **Federal Register d
cy reasons**~N~019058~001~~Sep 13, 1989~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~TENSILON~VALEANT PHARMS~10MG/ML~N~0079
59~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS NORTH AME

RICA
EDROPHONIUM CHLORIDE~INJECTABLE;INJECTION~TENSILON PRESERVATIVE FREE~VALEANT PHA
RMS~10MG/ML~N~007959~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMAC
EUTICALS NORTH AMERICA
TERBUTALINE SULFATE~INJECTABLE;INJECTION~TERBUTALINE SULFATE~AKORN~1MG/ML~A~0781
51~001~AP~Jan 7, 2008~No~RX~AKORN INC
TERBUTALINE SULFATE~INJECTABLE;INJECTION~TERBUTALINE SULFATE~BEDFORD~1MG/ML~A~07
6770~001~AP~Apr 23, 2004~Yes~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES
INC
TERBUTALINE SULFATE~INJECTABLE;INJECTION~TERBUTALINE SULFATE~FRESENIUS KABI USA~
1MG/ML~A~076887~001~AP~May 26, 2004~No~RX~FRESENIUS KABI USA LLC
TERBUTALINE SULFATE~INJECTABLE;INJECTION~TERBUTALINE SULFATE~HIKMA FARMACEUTICA~
1MG/ML~A~078630~001~AP~May 20, 2009~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
TERBUTALINE SULFATE~INJECTABLE;INJECTION~TERBUTALINE SULFATE~TEVA PHARMS USA~1MG
/ML~A~076853~001~~Jul 20, 2004~No~DISCN~TEVA PHARMACEUTICALS USA
TERBUTALINE SULFATE~INJECTABLE;INJECTION~TERBUTALINE SULFATE~UNITED BIOMEDCL~1MG
/ML~A~200122~001~AP~Nov 8, 2013~No~RX~UNITED BIOMEDICAL INC
LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE~INJECTABLE;INJECTION~TERRAMYCIN~PFIZER~
2%;50MG/ML~A~060567~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATOR
IES DIV PFIZER INC
LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE~INJECTABLE;INJECTION~TERRAMYCIN~PFIZER~
2%;125MG/ML~A~060567~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATO
RIES DIV PFIZER INC
OXYTETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~TERRAMYCIN~PFIZER~EQ 250MG BA
SE/VIAL~A~060586~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES
DIV PFIZER INC
OXYTETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~TERRAMYCIN~PFIZER~EQ 500MG BA
SE/VIAL~A~060586~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES
DIV PFIZER INC
TESTOLACTONE~INJECTABLE;INJECTION~TESLAC~BRISTOL MYERS SQUIBB~100MG/ML~N~016119~
001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
MANGAFODIPIR TRISODIUM~INJECTABLE;INJECTION~TESLASCAN~GE HEALTHCARE~37.9MG/ML~N~
020652~001~~Nov 26, 1997~No~DISCN~GE HEALTHCARE
TESTOSTERONE~INJECTABLE;INJECTION~TESTOSTERONE~WATSON LABS~25MG/ML~A~086420~001~
~May 10, 1983~No~DISCN~WATSON LABORATORIES INC
TESTOSTERONE~INJECTABLE;INJECTION~TESTOSTERONE~WATSON LABS~50MG/ML~A~086419~001~
~Aug 23, 1983~No~DISCN~WATSON LABORATORIES INC
TESTOSTERONE~INJECTABLE;INJECTION~TESTOSTERONE~WATSON LABS~100MG/ML~A~086417~001
~~Jul 7, 1983~No~DISCN~WATSON LABORATORIES INC
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~BEDFORD~100MG
/ML~A~090387~001~AO~Jul 15, 2010~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORA
TORIES INC
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~BEDFORD~200MG
/ML~A~090387~002~AO~Jul 15, 2010~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORA
TORIES INC
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~HIKMA FARMACE
UTICA~200MG/ML~A~091244~001~AO~May 1, 2012~No~RX~HIKMA FARMACEUTICA (PORTUGAL) S
A
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~MYLAN INSTITU
TIONAL~200MG/ML~A~040652~001~AO~Dec 11, 2006~No~RX~MYLAN INSTITUTIONAL LLC
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~PADDOCK LLC~2
00MG/ML~A~040530~001~AO~Jan 31, 2005~No~RX~PADDOCK LABORATORIES LLC
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~SANDOZ~100MG/
ML~A~040615~001~AO~Aug 10, 2006~No~RX~SANDOZ CANADA INC
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~SANDOZ~200MG/
ML~A~040615~002~AO~Aug 10, 2006~No~RX~SANDOZ CANADA INC
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~SUN PHARM IND
S LTD~100MG/ML~A~201720~001~AO~Jun 3, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES L
TD
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~SUN PHARM IND

S LTD~200MG/ML~A~201720~002~AO~Jun 3, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES L
TD
TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CYPIONATE~WATSON LABS~1
INC
INC
INC
00MG/ML~A~086030~001~AO~Approved Prior to Jan 1, 1982~No~RX~WATSON LABORATORIES
INC
ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE~INJECTABLE;INJECTION~TESTOSTERONE CY
PIONATE-ESTRADIOL CYPIONATE~WATSON LABS~2MG/ML;50MG/ML~A~085603~001~~Mar 13, 198
TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~TESTOSTERONE ENANTHATE~HIKMA FARMACE
UTICA~200MG/ML~A~091120~001~AO~Sep 18, 2012~No~RX~HIKMA FARMACEUTICA PORTUGAL SA
TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~TESTOSTERONE ENANTHATE~MYLAN INSTITU
TIONAL~200MG/ML~A~040647~001~AO~Oct 5, 2009~No~RX~MYLAN INSTITUTIONAL LLC
TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~TESTOSTERONE ENANTHATE~PADDOCK LLC~2
00MG/ML~A~040575~001~AO~Jun 14, 2006~No~RX~PADDOCK LABORATORIES LLC
TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~TESTOSTERONE ENANTHATE~WATSON LABS~1
INC
INC
INC
00MG/ML~A~085598~001~AO~Approved Prior to Jan 1, 1982~No~RX~WATSON LABORATORIES
INC
ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~TESTOSTERONE ENA
NTHATE AND ESTRADIOL VALERATE~WATSON LABS~4MG/ML;90MG/ML~A~085865~001~~Approved
Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE~INJECTABLE;INJECTION~TESTOSTERONE ENA
NTHATE AND ESTRADIOL VALERATE~WATSON LABS~8MG/ML;180MG/ML~A~085860~001~~Approved
TESTOSTERONE PROPIONATE~INJECTABLE;INJECTION~TESTOSTERONE PROPIONATE~BEL MAR~25M
G/ML~A~080741~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES I
NC
TESTOSTERONE PROPIONATE~INJECTABLE;INJECTION~TESTOSTERONE PROPIONATE~BEL MAR~50M
G/ML~A~080742~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES I
NC
TESTOSTERONE PROPIONATE~INJECTABLE;INJECTION~TESTOSTERONE PROPIONATE~BEL MAR~100
MG/ML~A~080743~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES
INC
TESTOSTERONE PROPIONATE~INJECTABLE;INJECTION~TESTOSTERONE PROPIONATE~ELKINS SINN
~25MG/ML~A~080276~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH
ROBINS CO INC
TESTOSTERONE PROPIONATE~INJECTABLE;INJECTION~TESTOSTERONE PROPIONATE~LILLY~50MG/
ML~A~080254~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
TESTOSTERONE PROPIONATE~INJECTABLE;INJECTION~TESTOSTERONE PROPIONATE~WATSON LABS
S INC

S INC
S INC
S INC
ES INC
ES INC
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~TETRACYN
~PFIZER~40MG/VIAL;100MG/VIAL~A~060285~002~~Approved Prior to Jan 1, 1982~No~DISC
N~PFIZER LABORATORIES DIV PFIZER INC
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~TETRACYN
~PFIZER~40MG/VIAL;250MG/VIAL~A~060285~003~~Approved Prior to Jan 1, 1982~No~DISC
N~PFIZER LABORATORIES DIV PFIZER INC
TETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~TETRACYN~PFIZER~250MG/VIAL~A~060
NC
TETRACYCLINE HYDROCHLORIDE~INJECTABLE;INJECTION~TETRACYN~PFIZER~500MG/VIAL~A~060
NC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~TEV-TROPIN~FERRING~5MG/VIAL~N~019774
~002~BX~Jan 4, 2002~Yes~RX~FERRING PHARMACEUTICALS INC
THALLOUS CHLORIDE TL-201~INJECTABLE;INJECTION~THALLOUS CHLORIDE TL 201~BRACCO~1m
Ci/ML~N~018548~001~~Dec 30, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
THALLOUS CHLORIDE TL-201~INJECTABLE;INJECTION~THALLOUS CHLORIDE TL 201~GE HEALTH
CARE~1mCi/ML~N~018110~002~AP~Feb 27, 1996~Yes~RX~GE HEALTHCARE
THALLOUS CHLORIDE TL-201~INJECTABLE;INJECTION~THALLOUS CHLORIDE TL 201~LANTHEUS
MEDCL~1mCi/ML~N~017806~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~LANTHEUS MEDI
CAL IMAGING INC
THALLOUS CHLORIDE TL-201~INJECTABLE;INJECTION~THALLOUS CHLORIDE TL 201~MALLINCKR
ODT~1mCi/ML~N~018150~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~MALLINCKRODT ME
DICAL INC
THALLOUS CHLORIDE TL-201~INJECTABLE;INJECTION~THALLOUS CHLORIDE TL 201~TRACE LIF
E~1mCi/ML~A~075569~001~~Nov 21, 2001~No~DISCN~TRACE LIFE SCIENCES INC
TROMETHAMINE~INJECTABLE;INJECTION~THAM~HOSPIRA~3.6GM/100ML~N~013025~002~~Approve
d Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE~INJECTABLE;INJECTION~THAM-E~HO
SPIRA~370MG/VIAL;1.75GM/VIAL;36GM/VIAL~N~013025~001~~Approved Prior to Jan 1, 19
ESTRONE~INJECTABLE;INJECTION~THEELIN~PARKEDALE~1MG/ML~N~003977~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
THEOPHYLLINE~INJECTABLE;INJECTION~THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC
CONTAINER~B BRAUN~40MG/100ML~N~019083~001~~Nov 7, 1984~No~DISCN~B BRAUN MEDICAL
INC
CONTAINER~B BRAUN~40MG/100ML~N~019826~001~AP~Aug 14, 1992~Yes~RX~B BRAUN MEDICAL
INC
INC

CONTAINER~B BRAUN~80MG/100ML~N~019826~002~AP~Aug 14, 1992~Yes~RX~B BRAUN MEDICAL
INC
INC
CONTAINER~B BRAUN~160MG/100ML~N~019826~003~AP~Aug 14, 1992~Yes~RX~B BRAUN MEDICA
L INC
THEOPHYLLINE~INJECTABLE;INJECTION~THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC C
ONTAINER~B BRAUN~200MG/100ML~N~019212~001~~Nov 7, 1984~No~DISCN~B BRAUN MEDICAL
INC
ONTAINER~B BRAUN~200MG/100ML~N~019826~004~~Aug 14, 1992~No~DISCN~B BRAUN MEDICAL
INC
CONTAINER~B BRAUN~320MG/100ML~N~019826~006~AP~Aug 14, 1992~Yes~RX~B BRAUN MEDICA
L INC
ONTAINER~B BRAUN~4MG/ML~N~019212~003~~Nov 7, 1984~No~DISCN~B BRAUN MEDICAL INC
ONTAINER~B BRAUN~400MG/100ML~N~019212~002~~Nov 7, 1984~No~DISCN~B BRAUN MEDICAL
INC
ONTAINER~B BRAUN~400MG/100ML~N~019826~005~~Aug 14, 1992~No~DISCN~B BRAUN MEDICAL
INC
THEOPHYLLINE~INJECTABLE;INJECTION~THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAI
NER~BAXTER HLTHCARE~4MG/ML~N~018649~007~~Jul 26, 1982~No~DISCN~BAXTER HEALTHCARE
CORP
NER~BAXTER HLTHCARE~40MG/100ML~N~018649~001~~Jul 26, 1982~No~DISCN~BAXTER HEALTH
CARE CORP
NER~BAXTER HLTHCARE~80MG/100ML~N~018649~002~~Jul 26, 1982~No~DISCN~BAXTER HEALTH
CARE CORP
NER~BAXTER HLTHCARE~160MG/100ML~N~018649~003~~Jul 26, 1982~No~DISCN~BAXTER HEALT
HCARE CORP
HCARE CORP
NER~BAXTER HLTHCARE~320MG/100ML~N~018649~006~~Nov 13, 1985~No~DISCN~BAXTER HEALT
HCARE CORP
HCARE CORP
THEOPHYLLINE~INJECTABLE;INJECTION~THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAIN
ER~HOSPIRA INC~4MG/ML~N~019211~007~AP~Dec 14, 1984~Yes~RX~HOSPIRA INC
ER~HOSPIRA INC~40MG/100ML~N~019211~001~AP~Dec 14, 1984~Yes~RX~HOSPIRA INC
ER~HOSPIRA INC~80MG/100ML~N~019211~002~~Dec 14, 1984~No~DISCN~HOSPIRA INC
ER~HOSPIRA INC~160MG/100ML~N~019211~003~AP~Dec 14, 1984~Yes~RX~HOSPIRA INC
ER~HOSPIRA INC~320MG/100ML~N~019211~006~AP~Jan 20, 1988~Yes~RX~HOSPIRA INC

THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~ABRAXIS PHARM
~100MG/ML~A~080509~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABRAXIS PHARMACEU
TICAL PRODUCTS
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~AKORN~100MG/M
L~A~087968~001~~Oct 1, 1982~No~DISCN~AKORN INC
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~BEL MAR~100MG
/ML~A~080718~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES IN
C
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~BEL MAR~200MG
/ML~A~080712~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORATORIES IN
C
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~DELL LABS~100
MG/ML~A~083775~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELL LABORATORIES INC
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~FRESENIUS KAB
I USA~100MG/ML~A~080556~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KA
BI USA LLC
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~HIKMA MAPLE ~
100MG/ML~A~080575~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA MAPLE LTD
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~HOSPIRA~100MG
/ML~A~040079~001~~May 3, 1996~No~DISCN~HOSPIRA WORLDWIDE, INC
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~LUITPOLD~100M
G/ML~A~080667~001~~Approved Prior to Jan 1, 1982~No~DISCN~LUITPOLD PHARMACEUTICA
LS INC
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~MYLAN INSTITU
TIONAL~100MG/ML~A~091623~001~AP~Jun 25, 2012~No~RX~MYLAN INSTITUTIONAL LLC
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~PARKE DAVIS~1
00MG/ML~A~080770~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WAR
NER LAMBERT CO
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~WATSON LABS~1
INC
INC
INC
INC
THIAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~THIAMINE HYDROCHLORIDE~WYETH AYERST~
100MG/ML~A~080553~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABOR
ATORIES
THIOTEPA~INJECTABLE;INJECTION~THIOPLEX~IMMUNEX~15MG/VIAL~N~020058~001~~Dec 22, 1
994~No~DISCN~IMMUNEX CORP
THIOTEPA~INJECTABLE;INJECTION~THIOTEPA~EUROHLTH INTL SARL~15MG/VIAL~A~075547~001
~~Apr 2, 2001~No~RX~EUROHEALTH INTERNATIONAL SARL
THIOTEPA~INJECTABLE;INJECTION~THIOTEPA~FRESENIUS KABI USA~15MG/VIAL~A~075698~001
~~Sep 20, 2001~No~DISCN~FRESENIUS KABI USA LLC
THIOTEPA~INJECTABLE;INJECTION~THIOTEPA~IMMUNEX~15MG/VIAL~N~011683~001~~Approved
Prior to Jan 1, 1982~No~DISCN~IMMUNEX CORP
THIOTEPA~INJECTABLE;INJECTION~THIOTEPA~TEVA PARENTERAL~15MG/VIAL~A~075730~001~~A
pr 20, 2001~No~DISCN~TEVA PARENTERAL MEDICINES INC
THIOTEPA~INJECTABLE;INJECTION~THIOTEPA~TEVA PARENTERAL~30MG/VIAL~A~075730~002~~A
pr 20, 2001~No~DISCN~TEVA PARENTERAL MEDICINES INC
CHLORPROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~THORAZINE~GLAXOSMITHKLINE~25MG
/ML~N~009149~011~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
PROTIRELIN~INJECTABLE;INJECTION~THYPINONE~ABBOTT~0.5MG/ML~N~017638~001~~Approved
PROTIRELIN~INJECTABLE;INJECTION~THYREL TRH~FERRING~0.5MG/ML~N~018087~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~FERRING PHARMACEUTICALS INC
THYROTROPIN ALFA~INJECTABLE;INJECTION~THYROGEN~GENZYME~1.1MG/VIAL~N~020898~001~~
Nov 30, 1998~Yes~RX~GENZYME CORP
THYROTROPIN~INJECTABLE;INJECTION~THYTROPAR~SANOFI AVENTIS US~10 IU/VIAL~N~008682
~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
TICARCILLIN DISODIUM~INJECTABLE;INJECTION~TICAR~GLAXOSMITHKLINE~EQ 1GM BASE/VIAL
~N~050497~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
TICARCILLIN DISODIUM~INJECTABLE;INJECTION~TICAR~GLAXOSMITHKLINE~EQ 20GM BASE/VIA
L~N~050497~004~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
TICARCILLIN DISODIUM~INJECTABLE;INJECTION~TICAR~GLAXOSMITHKLINE~EQ 30GM BASE/VIA
L~N~050497~005~~Apr 4, 1984~No~DISCN~GLAXOSMITHKLINE
TRIMETHOBENZAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~TIGAN~PAR STERILE PRODUCTS~
100MG/ML~N~017530~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~PAR STERILE PRODUC
TS LLC
CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM~INJECTABLE;INJECTION~TIMENTIN~GLAXOS
MITHKLINE~EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL~N~050590~003~~Aug 18, 1987~Yes~RX~G
LAXOSMITHKLINE
MITHKLINE~EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL~A~062691~001~~Dec 19, 1986~No~RX~G
LAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND
MITHKLINE~EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL~N~050590~001~~Apr 1, 1985~Yes~RX~G
LAXOSMITHKLINE
MITHKLINE~EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL~N~050590~002~~Apr 1, 1985~Yes~RX~G
LAXOSMITHKLINE
CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM~INJECTABLE;INJECTION~TIMENTIN IN PLA
STIC CONTAINER~GLAXOSMITHKLINE~EQ 100MG BASE/100ML;EQ 3GM BASE/100ML~N~050658~00
1~~Dec 15, 1989~Yes~RX~GLAXOSMITHKLINE
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~AGILA SPECLTS~EQ 40MG
BASE/ML~A~065407~001~AP~Mar 11, 2008~No~RX~AGILA SPECIALTIES PRIVATE LTD
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~AKORN~EQ 40MG BASE/ML
~A~205179~001~AP~Sep 16, 2014~No~RX~AKORN INC
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~APOTHECON~EQ 10MG BAS
E/ML~A~064021~001~~May 31, 1994~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~ASTRAZENECA~EQ 10MG B
ASE/ML~A~063119~001~~Oct 31, 1994~No~DISCN~ASTRAZENECA LP
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~FRESENIUS KABI USA~EQ
1.2GM BASE/VIAL~N~050789~001~AP~Jul 13, 2004~No~RX~FRESENIUS KABI USA LLC
10MG BASE/ML~A~065122~001~AP~Nov 29, 2002~No~RX~FRESENIUS KABI USA LLC
40MG BASE/ML~A~065122~002~AP~Nov 29, 2002~Yes~RX~FRESENIUS KABI USA LLC
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~HIKMA MAPLE ~EQ 10MG

BASE/ML~A~063113~001~~Apr 26, 1991~No~DISCN~HIKMA MAPLE LTD
BASE/ML~A~063128~001~~Nov 27, 1991~No~DISCN~HIKMA MAPLE LTD
BASE/ML~A~063117~001~AP~Apr 26, 1991~No~RX~HIKMA MAPLE LTD
BASE/ML~A~063118~001~~Jul 29, 1991~No~DISCN~HIKMA MAPLE LTD
BASE/ML~A~063127~001~~Nov 27, 1991~No~DISCN~HIKMA MAPLE LTD
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~HOSPIRA~EQ 10MG BASE/
ML~A~063080~001~~Apr 30, 1991~No~DISCN~HOSPIRA WORLDWIDE, INC
ML~A~063112~001~AP~Apr 30, 1991~Yes~RX~HOSPIRA WORLDWIDE, INC
ML~A~063111~001~AP~Apr 30, 1991~No~RX~HOSPIRA INC
ML~A~063116~001~AP~May 18, 1992~Yes~RX~HOSPIRA INC
ML~A~063161~001~~May 29, 1991~No~DISCN~HOSPIRA INC
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~TEVA PHARMS USA~EQ 40
MG BASE/ML~A~063100~001~AP~Jan 30, 1992~No~RX~TEVA PHARMACEUTICALS USA
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~WATSON LABS INC~EQ 10
MG BASE/ML~A~062945~001~~Aug 9, 1989~No~DISCN~WATSON LABORATORIES INC
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~WATSON LABS INC~EQ 40
MG BASE/ML~A~062945~002~~Aug 9, 1989~No~DISCN~WATSON LABORATORIES INC
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~X GEN PHARMS~EQ 1.2GM
BASE/VIAL~A~065013~001~AP~Aug 17, 2001~Yes~RX~X GEN PHARMACEUTICALS INC
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE~XELLIA PHARMS APS~EQ
1.2GM BASE/VIAL~A~205685~001~AP~Sep 16, 2014~No~RX~XELLIA PHARMACEUTICALS APS
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE (PHARMACY BULK)~FRESE
NIUS KABI USA~EQ 40MG BASE/ML~A~065120~001~AP~Nov 29, 2002~No~RX~FRESENIUS KABI
USA LLC
TOBRAMYCIN SULFATE~INJECTABLE;INJECTION~TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 1.2MG BASE/ML~A~063081~003~~Jul 31, 1990~Yes~
RX~HOSPIRA INC
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 1.6MG BASE/ML~A~063081~006~~Jun 2, 1993~Yes~R
X~HOSPIRA INC
9% IN PLASTIC CONTAINER~HOSPIRA~EQ 80MG BASE/100ML~A~063081~001~~Jul 31, 1990~Ye
s~RX~HOSPIRA INC
IMIPRAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~TOFRANIL~NOVARTIS~12.5MG/ML~N~0118
ETOPOSIDE~INJECTABLE;INJECTION~TOPOSAR~TEVA PARENTERAL~20MG/ML~A~074166~001~~Feb
27, 1995~No~DISCN~TEVA PARENTERAL MEDICINES INC
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~ACCORD HLTH
CARE~EQ 4MG BASE/VIAL~A~202351~001~AP~Jun 26, 2013~No~RX~ACCORD HEALTHCARE INC
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~ACTAVIS TOT
OWA~EQ 4MG BASE/VIAL~A~090620~001~AP~Dec 2, 2010~No~RX~ACTAVIS TOTOWA LLC
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~CIPLA LTD~E
Q 4MG BASE/VIAL~A~091199~001~AP~Dec 1, 2010~No~RX~CIPLA LTD
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~DR REDDYS L
ABS LTD~EQ 4MG BASE/VIAL~A~201191~001~AP~Mar 9, 2011~No~RX~DR REDDYS LABORATORIE
S LTD
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~FRESENIUS K
ABI ONCOL~EQ 4MG BASE/VIAL~A~091376~001~~Nov 29, 2010~No~DISCN~FRESENIUS KABI ON
COLOGY PLC
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~FRESENIUS K
ABI USA~EQ 4MG BASE/VIAL~A~091089~001~AP~Nov 29, 2010~No~RX~FRESENIUS KABI USA L
LC
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~INNOPHARMA
LICENSING~EQ 4MG BASE/VIAL~A~201166~001~AP~Aug 8, 2012~No~RX~INNOPHARMA LICENSIN
G LLC
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~ONCO THERAP
IES LTD~EQ 4MG BASE/VIAL~A~091542~001~AP~Aug 28, 2012~No~RX~ONCO THERAPIES LTD
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~SAGENT PHAR
MS~EQ 4MG BASE/VIAL~A~091284~001~AP~Jan 26, 2011~No~RX~SAGENT PHARMACEUTICALS IN
C
TOPOTECAN HYDROCHLORIDE~INJECTABLE;INJECTION~TOPOTECAN HYDROCHLORIDE~SUN PHARM I
NDS LTD~EQ 4MG BASE/VIAL~A~202203~001~AP~Aug 29, 2013~No~RX~SUN PHARMACEUTICAL I
NDUSTRIES LTD
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~TORADOL~ROCHE PALO~15MG/ML~N~019698~
001~~Nov 30, 1989~No~DISCN~ROCHE PALO ALTO LLC
KETOROLAC TROMETHAMINE~INJECTABLE;INJECTION~TORADOL~ROCHE PALO~30MG/ML~N~019698~
002~~Nov 30, 1989~No~DISCN~ROCHE PALO ALTO LLC
THIETHYLPERAZINE MALATE~INJECTABLE;INJECTION~TORECAN~NOVARTIS~5MG/ML~N~012754~00
TORSEMIDE~INJECTABLE;INJECTION~TORSEMIDE~EUROHLTH INTL SARL~20MG/2ML (10MG/ML)~A
~078007~001~~Jun 11, 2008~No~DISCN~EUROHEALTH INTERNATIONAL SARL
TORSEMIDE~INJECTABLE;INJECTION~TORSEMIDE~EUROHLTH INTL SARL~50MG/5ML (10MG/ML)~A
~078007~002~~Jun 11, 2008~No~DISCN~EUROHEALTH INTERNATIONAL SARL
TORSEMIDE~INJECTABLE;INJECTION~TORSEMIDE~LUITPOLD~20MG/2ML (10MG/ML)~A~090656~00
1~~Apr 21, 2010~No~DISCN~LUITPOLD PHARMACEUTICALS INC
TORSEMIDE~INJECTABLE;INJECTION~TORSEMIDE~LUITPOLD~50MG/5ML (10MG/ML)~A~090656~00
2~~Apr 21, 2010~No~DISCN~LUITPOLD PHARMACEUTICALS INC
AMPICILLIN SODIUM~INJECTABLE;INJECTION~TOTACILLIN-N~GLAXOSMITHKLINE~EQ 1GM BASE/
VIAL~A~060677~004~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
VIAL~A~062727~001~~Dec 19, 1986~No~DISCN~GLAXOSMITHKLINE
VIAL~A~060677~005~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
VIAL~A~062727~002~~Dec 19, 1986~No~DISCN~GLAXOSMITHKLINE
AMPICILLIN SODIUM~INJECTABLE;INJECTION~TOTACILLIN-N~GLAXOSMITHKLINE~EQ 10GM BASE
/VIAL~A~060677~006~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
AMPICILLIN SODIUM~INJECTABLE;INJECTION~TOTACILLIN-N~GLAXOSMITHKLINE~EQ 125MG BAS
E/VIAL~A~060677~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
DEXRAZOXANE HYDROCHLORIDE~INJECTABLE;INJECTION~TOTECT~BIOCODEX INC~EQ 500MG BASE
/VIAL~N~022025~001~~Sep 6, 2007~Yes~RX~BIOCODEX INC
CHLORIDE~INJECTABLE;INJECTION~TPN ELECTROLYTES IN PLASTIC CONTAINER~ABBOTT~16.5
MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML~N~019399~001~~Jun 16, 1986~No~DISCN
~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
CHLORIDE~INJECTABLE;INJECTION~TPN ELECTROLYTES IN PLASTIC CONTAINER~HOSPIRA~16.
5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML~N~018895~001~~Jul 20, 1984~Yes~RX~
HOSPIRA INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~TRACRIUM~HOSPIRA~10MG/ML **Federal Regi
efficacy reasons**~N~018831~002~~Jun 20, 1985~No~DISCN~HOSPIRA INC
ATRACURIUM BESYLATE~INJECTABLE;INJECTION~TRACRIUM PRESERVATIVE FREE~HOSPIRA~10MG
/ML **Federal Register determination that product was not discontinued or withdr
awn for safety or efficacy reasons**~N~018831~001~~Nov 23, 1983~No~DISCN~HOSPIRA
INC
LABETALOL HYDROCHLORIDE~INJECTABLE;INJECTION~TRANDATE~PROMETHEUS LABS~5MG/ML~N~0
19425~001~~Dec 31, 1985~No~DISCN~PROMETHEUS LABORATORIES INC

TRANEXAMIC ACID~INJECTABLE;INJECTION~TRANEXAMIC ACID~ACIC FINE CHEMS~100MG/ML~A~
202436~001~AP~Feb 11, 2014~No~RX~ACIC FINE CHEMICALS INC
TRANEXAMIC ACID~INJECTABLE;INJECTION~TRANEXAMIC ACID~EMCURE PHARMS LTD~100MG/ML~
A~203521~001~AP~Aug 12, 2014~No~RX~EMCURE PHARMACEUTICALS LTD
TRANEXAMIC ACID~INJECTABLE;INJECTION~TRANEXAMIC ACID~FRESENIUS KABI USA~100MG/ML
~A~091596~001~~Mar 2, 2012~No~DISCN~FRESENIUS KABI USA LLC
TRANEXAMIC ACID~INJECTABLE;INJECTION~TRANEXAMIC ACID~LUITPOLD~100MG/ML~A~201885~
001~AP~Aug 10, 2011~No~RX~LUITPOLD PHARMACEUTICALS INC
TRANEXAMIC ACID~INJECTABLE;INJECTION~TRANEXAMIC ACID~MYLAN INSTITUTIONAL~100MG/M
L~A~091657~001~AP~Nov 3, 2011~No~RX~MYLAN INSTITUTIONAL LLC
TRANEXAMIC ACID~INJECTABLE;INJECTION~TRANEXAMIC ACID~VERSAPHARM INC~100MG/ML~A~2
02373~001~AP~Nov 17, 2011~No~RX~VERSAPHARM INCORPORATED
TRANEXAMIC ACID~INJECTABLE;INJECTION~TRANEXAMIC ACID~X-GEN PHARMS INC~100MG/ML~A
~201580~001~AP~Jun 14, 2013~No~RX~X-GEN PHARMACEUTICALS INC
APROTININ~INJECTABLE;INJECTION~TRASYLOL~BAYER HLTHCARE~10,000KIU/ML~N~020304~001
~~Dec 29, 1993~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
SOYBEAN OIL~INJECTABLE;INJECTION~TRAVAMULSION 10%~BAXTER HLTHCARE~10%~N~018660~0
01~~Feb 26, 1982~No~DISCN~BAXTER HEALTHCARE CORP
SOYBEAN OIL~INJECTABLE;INJECTION~TRAVAMULSION 20%~BAXTER HLTHCARE~20%~N~018758~0
01~~Feb 15, 1983~No~DISCN~BAXTER HEALTHCARE CORP
AMINO ACIDS~INJECTABLE;INJECTION~TRAVASOL 10% IN PLASTIC CONTAINER~BAXTER HLTHCA
RE~10% (10MG/100ML)~N~018931~003~~Aug 23, 1984~No~RX~BAXTER HEALTHCARE CORP
AMINO ACIDS~INJECTABLE;INJECTION~TRAVASOL 10% W/O ELECTROLYTES~BAXTER HLTHCARE~1
0% (10GM/100ML)~N~017493~006~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEAL
THCARE CORP
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~TRAVASOL 2.75% IN DEXTROSE 10% IN PLA
STIC CONTAINER~BAXTER HLTHCARE~2.75%;10GM/100ML~N~019520~002~~Sep 23, 1988~No~DI
SCN~BAXTER HEALTHCARE CORP
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~TRAVASOL 2.75% IN DEXTROSE 5% IN PLAS
TIC CONTAINER~BAXTER HLTHCARE~2.75%;5GM/100ML~N~019520~001~~Sep 23, 1988~No~DISC
N~BAXTER HEALTHCARE CORP
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM
ACETATE; SODIUM CHLORIDE~INJECTABLE;INJECTION~TRAVASOL 2.75% SULFITE FREE W/ ELE
CTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER~BAXTER HLTHCARE~2.75%;10GM/100ML;
51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML~N~020147~002~~Oct 23, 1995~No~DIS

CTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~2.75%;5GM/100ML;51
MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML~N~020147~001~~Oct 23, 1995~No~DISCN
~BAXTER HEALTHCARE CORP
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; S
ODIUM CHLORIDE~INJECTABLE;INJECTION~TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES I
N PLASTIC CONTAINER~BAXTER HLTHCARE~3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG
/100ML~N~020177~001~~Oct 23, 1995~No~DISCN~BAXTER HEALTHCARE CORP
ODIUM CHLORIDE~INJECTABLE;INJECTION~TRAVASOL 3.5% W/ ELECTROLYTES~BAXTER HLTHCAR
E~3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML~N~017493~003~~Approved Prio
r to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP
AMINO ACIDS; DEXTROSE~INJECTABLE;INJECTION~TRAVASOL 4.25% IN DEXTROSE 5% IN PLAS
TIC CONTAINER~BAXTER HLTHCARE~4.25%;5GM/100ML~N~019520~006~~Sep 23, 1988~No~DISC
51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML~N~020147~007~~Oct 23, 1995~No~DISC
CTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~4.25%;5GM/100ML;51
MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML~N~020147~006~~Oct 23, 1995~No~DISCN~
AMINO ACIDS~INJECTABLE;INJECTION~TRAVASOL 5.5% IN PLASTIC CONTAINER~BAXTER HLTHC
ARE~5.5% (5.5GM/100ML)~N~018931~001~~Aug 23, 1984~No~RX~BAXTER HEALTHCARE CORP
N PLASTIC CONTAINER~BAXTER HLTHCARE~5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224
MG/100ML~N~020173~001~~Oct 27, 1995~No~RX~BAXTER HEALTHCARE CORP

E~5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML~N~017493~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP
AMINO ACIDS~INJECTABLE;INJECTION~TRAVASOL 5.5% W/O ELECTROLYTES~BAXTER HLTHCARE~
5.5% (5.5GM/100ML)~N~017493~004~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER H
EALTHCARE CORP
AMINO ACIDS~INJECTABLE;INJECTION~TRAVASOL 8.5% IN PLASTIC CONTAINER~BAXTER HLTHC
ARE~8.5% (8.5GM/100ML)~N~018931~002~~Aug 23, 1984~No~RX~BAXTER HEALTHCARE CORP
N PLASTIC CONTAINER~BAXTER HLTHCARE~8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154
MG/100ML~N~020173~002~~Oct 27, 1995~No~RX~BAXTER HEALTHCARE CORP
E~8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML~N~017493~002~~Approved Pr
ior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP
AMINO ACIDS~INJECTABLE;INJECTION~TRAVASOL 8.5% W/O ELECTROLYTES~BAXTER HLTHCARE~
8.5% (8.5GM/100ML)~N~017493~005~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER H
EALTHCARE CORP
INVERT SUGAR~INJECTABLE;INJECTION~TRAVERT 10% IN PLASTIC CONTAINER~BAXTER HLTHCA
RE~10GM/100ML~N~016717~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTH
CARE CORP
TRIAMCINOLONE ACETONIDE~INJECTABLE;INJECTION~TRIAMCINOLONE ACETONIDE~PARNELL~3MG
/ML~N~019503~001~~Oct 16, 1987~No~DISCN~PARNELL PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~INJECTABLE;INJECTION~TRIAMCINOLONE ACETONIDE~SANDOZ~10MG
/ML~A~090166~001~~May 27, 2009~No~DISCN~SANDOZ CANADA INC
TRIAMCINOLONE ACETONIDE~INJECTABLE;INJECTION~TRIAMCINOLONE ACETONIDE~SANDOZ CANA
DA INC~40MG/ML~A~090164~001~~Jun 1, 2009~No~DISCN~SANDOZ CANADA INC
TRIAMCINOLONE ACETONIDE~INJECTABLE;INJECTION~TRIAMCINOLONE ACETONIDE~WATSON LABS
S INC
TRIAMCINOLONE DIACETATE~INJECTABLE;INJECTION~TRIAMCINOLONE DIACETATE~AKORN~25MG/
ML~A~085122~001~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
TRIAMCINOLONE DIACETATE~INJECTABLE;INJECTION~TRIAMCINOLONE DIACETATE~AKORN~40MG/
ML~A~086394~001~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
TRIAMCINOLONE DIACETATE~INJECTABLE;INJECTION~TRIAMCINOLONE DIACETATE~WATSON LABS
S INC
TRIAMCINOLONE DIACETATE~INJECTABLE;INJECTION~TRIAMCINOLONE DIACETATE~WATSON LABS
S INC
NITROGLYCERIN~INJECTABLE;INJECTION~TRIDIL~HOSPIRA~0.5MG/ML~N~018537~002~~Jun 16,
NITROGLYCERIN~INJECTABLE;INJECTION~TRIDIL~HOSPIRA~5MG/ML~N~018537~001~~Approved
Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
PERPHENAZINE~INJECTABLE;INJECTION~TRILAFON~SCHERING~5MG/ML~N~011213~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
TRIMETHOBENZAMIDE HYDROCHLORIDE~INJECTABLE;INJECTION~TRIMETHOBENZAMIDE HYDROCHLO
RIDE~HOSPIRA~100MG/ML~A~088804~001~~Apr 3, 1987~No~DISCN~HOSPIRA INC
RIDE~LUITPOLD~100MG/ML~A~091330~001~AP~Mar 8, 2011~No~RX~LUITPOLD PHARMACEUTICAL
S INC
RIDE~SMITH AND NEPHEW~100MG/ML~A~088960~001~~Apr 4, 1986~No~DISCN~SMITH AND NEPH
RIDE~SMITH AND NEPHEW~100MG/ML~A~089043~001~~Apr 4, 1986~No~DISCN~SMITH AND NEPH
RIDE~SOLOPAK~100MG/ML~A~089094~001~~Apr 4, 1986~No~DISCN~SOLOPAK MEDICAL PRODUCT

S INC
RIDE~WATSON LABS~100MG/ML~A~086577~001~~Oct 19, 1982~No~DISCN~WATSON LABORATORIE
S INC
RIDE~WATSON LABS~100MG/ML~A~087939~001~~Dec 28, 1982~No~DISCN~WATSON LABORATORIE
S INC
RIDE PRESERVATIVE FREE~LUITPOLD~100MG/ML~A~091329~001~AP~Mar 8, 2011~No~RX~LUITP
OLD PHARMACEUTICALS INC
LIOTHYRONINE SODIUM~INJECTABLE;INJECTION~TRIOSTAT~PAR STERILE PRODUCTS~EQ 0.01MG
BASE/ML~N~020105~001~AP~Dec 31, 1991~Yes~RX~PAR STERILE PRODUCTS LLC
ARSENIC TRIOXIDE~INJECTABLE;INJECTION~TRISENOX~CEPHALON~1MG/ML~N~021248~001~~Sep
25, 2000~Yes~RX~CEPHALON INC
SPECTINOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~TROBICIN~PFIZER~EQ 2GM BASE/VIA
L~N~050347~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER INC
SPECTINOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~TROBICIN~PFIZER~EQ 4GM BASE/VIA
L~N~050347~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER INC
AMINO ACIDS~INJECTABLE;INJECTION~TROPHAMINE~B BRAUN~6% (6GM/100ML)~N~019018~001~
~Jul 20, 1984~Yes~RX~B BRAUN MEDICAL INC
AMINO ACIDS~INJECTABLE;INJECTION~TROPHAMINE 10%~B BRAUN~10% (10GM/100ML)~N~01901
8~003~~Sep 7, 1988~Yes~RX~B BRAUN MEDICAL INC
ALATROFLOXACIN MESYLATE~INJECTABLE;INJECTION~TROVAN PRESERVATIVE FREE~PFIZER~EQ
200MG BASE/VIAL~N~020760~001~~Dec 18, 1997~No~DISCN~PFIZER CHEMICALS DIV PFIZER
INC
ALATROFLOXACIN MESYLATE~INJECTABLE;INJECTION~TROVAN PRESERVATIVE FREE~PFIZER~EQ
300MG BASE/VIAL~N~020760~002~~Dec 18, 1997~No~DISCN~PFIZER CHEMICALS DIV PFIZER
INC
TUBOCURARINE CHLORIDE~INJECTABLE;INJECTION~TUBOCURARINE CHLORIDE~BRISTOL MYERS S
QUIBB~3MG/ML~N~005657~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS
SQUIBB CO
TUBOCURARINE CHLORIDE~INJECTABLE;INJECTION~TUBOCURARINE CHLORIDE~HOSPIRA~3MG/ML~
N~006095~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
TUBOCURARINE CHLORIDE~INJECTABLE;INJECTION~TUBOCURARINE CHLORIDE~LILLY~3MG/ML~N~
CERULETIDE DIETHYLAMINE~INJECTABLE;INJECTION~TYMTRAN~PHARMACIA AND UPJOHN~0.02MG
/ML~N~018296~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
GENTAMICIN SULFATE~INJECTABLE;INJECTION~U-GENCIN~PHARMACIA AND UPJOHN~EQ 10MG BA
SE/ML~A~062248~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN
CO
GENTAMICIN SULFATE~INJECTABLE;INJECTION~U-GENCIN~PHARMACIA AND UPJOHN~EQ 40MG BA
SE/ML~A~062248~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN
CO
REMIFENTANIL HYDROCHLORIDE~INJECTABLE;INJECTION~ULTIVA~MYLAN INSTITUTIONAL~EQ 1M
G BASE/VIAL~N~020630~001~~Jul 12, 1996~No~RX~MYLAN INSTITUTIONAL LLC
G BASE/VIAL~N~020630~002~~Jul 12, 1996~No~RX~MYLAN INSTITUTIONAL LLC
G BASE/VIAL~N~020630~003~~Jul 12, 1996~Yes~RX~MYLAN INSTITUTIONAL LLC
INSULIN ZINC SUSP EXTENDED PURIFIED BEEF~INJECTABLE;INJECTION~ULTRALENTE~NOVO NO
RDISK INC~100 UNITS/ML~N~018385~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO
NORDISK INC
INSULIN ZINC SUSP EXTENDED BEEF~INJECTABLE;INJECTION~ULTRALENTE INSULIN~NOVO NOR
DISK INC~100 UNITS/ML~N~017997~003~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO
NORDISK INC
TECHNETIUM TC-99M RED BLOOD CELL KIT~INJECTABLE;INJECTION~ULTRATAG~MALLINCKRODT~
N/A~N~019981~001~~Jun 10, 1991~No~RX~MALLINCKRODT MEDICAL INC
IOPROMIDE~INJECTABLE;INJECTION~ULTRAVIST (PHARMACY BULK)~BAYER HLTHCARE~49.9%~N~
021425~003~~Mar 12, 2004~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC

021425~001~~Sep 20, 2002~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
021425~002~~Sep 20, 2002~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
IOPROMIDE~INJECTABLE;INJECTION~ULTRAVIST 150~BAYER HLTHCARE~31.2%~N~020220~004~~
May 10, 1995~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
IOPROMIDE~INJECTABLE;INJECTION~ULTRAVIST 300 IN PLASTIC CONTAINER~BAYER HLTHCARE
~62.3%~N~020220~005~~Nov 18, 2008~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
AMPICILLIN SODIUM; SULBACTAM SODIUM~INJECTABLE;INJECTION~UNASYN~PFIZER~EQ 2GM BA
SE/VIAL;EQ 1GM BASE/VIAL~A~062901~002~AP~Feb 27, 1992~Yes~RX~PFIZER LABORATORIES
DIV PFIZER INC
SE/VIAL;EQ 500MG BASE/VIAL~A~062901~001~AP~Nov 23, 1988~Yes~RX~PFIZER LABORATORI
ES DIV PFIZER INC
SE/VIAL;EQ 500MG BASE/VIAL~N~050608~002~AP~Dec 31, 1986~Yes~RX~PFIZER INC
SE/VIAL;EQ 1GM BASE/VIAL~N~050608~001~AP~Dec 31, 1986~Yes~RX~PFIZER INC
AMPICILLIN SODIUM; SULBACTAM SODIUM~INJECTABLE;INJECTION~UNASYN~PFIZER~EQ 10GM B
ASE/VIAL;EQ 5GM BASE/VIAL~N~050608~005~AP~Dec 10, 1993~Yes~RX~PFIZER INC
AMPICILLIN SODIUM; SULBACTAM SODIUM~INJECTABLE;INJECTION~UNASYN~PFIZER~EQ 500MG
BASE/VIAL;EQ 250MG BASE/VIAL~N~050608~003~~Dec 31, 1986~No~DISCN~PFIZER INC
NAFCILLIN SODIUM~INJECTABLE;INJECTION~UNIPEN~WYETH AYERST~EQ 1GM BASE/VIAL~A~062
717~002~~Dec 16, 1986~No~DISCN~WYETH AYERST LABORATORIES
NAFCILLIN SODIUM~INJECTABLE;INJECTION~UNIPEN~WYETH AYERST~EQ 2GM BASE/VIAL~A~062
NAFCILLIN SODIUM~INJECTABLE;INJECTION~UNIPEN~WYETH AYERST~EQ 2GM BASE/VIAL~N~050
NAFCILLIN SODIUM~INJECTABLE;INJECTION~UNIPEN~WYETH AYERST~EQ 500MG BASE/VIAL~A~0
NAFCILLIN SODIUM~INJECTABLE;INJECTION~UNIPEN~WYETH AYERST~EQ 500MG BASE/VIAL~N~0
NAFCILLIN SODIUM~INJECTABLE;INJECTION~UNIPEN IN PLASTIC CONTAINER~WYETH AYERST~E
Q 1GM BASE/VIAL~N~050320~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERS
T LABORATORIES
CRYPTENAMINE ACETATES~INJECTABLE;INJECTION~UNITENSEN~MEDPOINTE PHARM HLC~260CSR
UNIT/ML~N~008814~001~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEU
TICALS MEDPOINTE HEALTHCARE INC
UREA~INJECTABLE;INJECTION~UREAPHIL~HOSPIRA~40GM/VIAL~N~012154~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~HOSPIRA INC
BETHANECHOL CHLORIDE~INJECTABLE;INJECTION~URECHOLINE~ODYSSEY PHARMS~5MG/ML **Fed
afety or efficacy reasons**~N~006536~001~~Approved Prior to Jan 1, 1982~No~DISCN
~ODYSSEY PHARMACEUTICALS INC
DIATRIZOATE MEGLUMINE~INJECTABLE;INJECTION~UROVIST MEGLUMINE DIU/CT~BAYER HLTHCA
RE~30%~A~087739~001~~Sep 23, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
DIATRIZOATE SODIUM~INJECTABLE;INJECTION~UROVIST SODIUM 300~BAYER HLTHCARE~50%~A~
METHOXSALEN~INJECTABLE;INJECTION~UVADEX~THERAKOS~0.02MG/ML~N~020969~001~~Feb 25,
1999~Yes~RX~THERAKOS INC
DIAZEPAM~INJECTABLE;INJECTION~VALIUM~ROCHE~5MG/ML~N~016087~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
VALPROATE SODIUM~INJECTABLE;INJECTION~VALPROATE SODIUM~BEDFORD~EQ 100MG BASE/ML~
A~076295~001~AP~Nov 14, 2002~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORI
ES INC
VALPROATE SODIUM~INJECTABLE;INJECTION~VALPROATE SODIUM~FRESENIUS KABI USA~EQ 100
MG BASE/ML~A~076539~001~AP~Jun 26, 2003~No~RX~FRESENIUS KABI USA LLC
VALPROATE SODIUM~INJECTABLE;INJECTION~VALPROATE SODIUM~HIKMA FARMACEUTICA~EQ 100
MG BASE/ML~A~078523~001~AP~Feb 17, 2010~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~VALTROPIN~LG LIFE~5MG/VIAL~N~021905~
001~BX~Apr 19, 2007~No~RX~LG LIFE SCIENCES LTD
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOCIN HYDROCHLORIDE~ANI PHARMS
INC~EQ 1GM BASE/VIAL~A~060180~002~~Mar 21, 1986~No~DISCN~ANI PHARMACEUTICALS INC
INC~EQ 1GM BASE/VIAL~A~062812~002~~Nov 17, 1987~No~DISCN~ANI PHARMACEUTICALS INC
INC~EQ 10GM BASE/VIAL~A~062812~003~~Nov 17, 1987~No~DISCN~ANI PHARMACEUTICALS IN
C
INC~EQ 500MG BASE/VIAL~A~060180~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANI
PHARMACEUTICALS INC
INC~EQ 500MG BASE/VIAL~A~062476~001~~Mar 15, 1984~No~DISCN~ANI PHARMACEUTICALS I
NC
INC~EQ 500MG BASE/VIAL~A~062716~001~~Mar 13, 1987~No~DISCN~ANI PHARMACEUTICALS I
NC
INC~EQ 500MG BASE/VIAL~A~062812~001~~Nov 17, 1987~No~DISCN~ANI PHARMACEUTICALS I
NC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOCIN HYDROCHLORIDE IN PLASTIC
CONTAINER~BAXTER HLTHCARE~EQ 500MG BASE/100ML~N~050671~001~~Apr 29, 1993~Yes~RX~
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOCIN HYDROCHLORIDE IN PLASTIC
CONTAINER~BAXTER HLTHCARE~EQ 750MG BASE/150ML~N~050671~002~~Dec 20, 2010~Yes~RX~
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOLED~HIKMA MAPLE ~EQ 1GM BASE/
VIAL~A~062682~002~~Mar 30, 1988~No~DISCN~HIKMA MAPLE LTD
VIAL~A~062682~003~~May 11, 1988~No~DISCN~HIKMA MAPLE LTD
VIAL~A~062682~004~~May 11, 1988~No~DISCN~HIKMA MAPLE LTD
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOLED~HIKMA MAPLE ~EQ 10GM BASE
/VIAL~A~062682~005~~May 11, 1988~No~DISCN~HIKMA MAPLE LTD
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOLED~HIKMA MAPLE ~EQ 500MG BAS
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~AGILA SPE
CLTS~EQ 1GM BASE/VIAL~A~065397~002~AP~Dec 30, 2008~No~RX~AGILA SPECIALTIES PRIVA
TE LTD
CLTS~EQ 5GM BASE/VIAL~A~065432~001~AP~Dec 30, 2008~No~RX~AGILA SPECIALTIES PRIVA
TE LTD
CLTS~EQ 10GM BASE/VIAL~A~091469~001~AP~Jul 1, 2011~No~RX~AGILA SPECIALTIES PRIVA
TE LTD
CLTS~EQ 10GM BASE/VIAL~A~091554~001~AP~Sep 19, 2011~No~RX~AGILA SPECIALTIES PRIV
ATE LTD
CLTS~EQ 500MG BASE/VIAL~A~065397~001~AP~Dec 30, 2008~No~RX~AGILA SPECIALTIES PRI
VATE LTD
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~EMCURE PH
ARMS LTD~EQ 1GM BASE/VIAL~A~202275~002~AP~Oct 31, 2013~No~RX~EMCURE PHARMACEUTIC
ALS LTD
ALS LTD
ALS LTD
ARMS LTD~EQ 500MG BASE/VIAL~A~202275~001~AP~Oct 31, 2013~No~RX~EMCURE PHARMACEUT
ICALS LTD
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~FRESENIUS
KABI USA~EQ 1GM BASE/VIAL~A~062663~002~AP~Jul 31, 1987~Yes~RX~FRESENIUS KABI US
A LLC
KABI USA~EQ 5GM BASE/VIAL~A~062663~003~AP~Jun 3, 1988~Yes~RX~FRESENIUS KABI USA
LLC
KABI USA~EQ 10GM BASE/VIAL~A~062663~004~AP~Nov 28, 1997~Yes~RX~FRESENIUS KABI U
SA LLC
KABI USA~EQ 500MG BASE/VIAL~A~062663~001~AP~Mar 17, 1987~Yes~RX~FRESENIUS KABI
USA LLC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~HIKMA MAP
LE ~EQ 1GM BASE/VIAL~A~062879~002~~Aug 2, 1988~No~DISCN~HIKMA MAPLE LTD
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~HIKMA MAP
LE ~EQ 500MG BASE/VIAL~A~062879~001~~Aug 2, 1988~No~DISCN~HIKMA MAPLE LTD
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~HOSPIRA~E
Q 1GM BASE/VIAL~A~062912~001~AP~Aug 4, 1988~Yes~RX~HOSPIRA INC
Q 1GM BASE/VIAL~A~062933~001~AP~Oct 29, 1992~Yes~RX~HOSPIRA INC
Q 5GM BASE/VIAL~A~063076~001~AP~Dec 21, 1990~Yes~RX~HOSPIRA INC
Q 500MG BASE/VIAL~A~062911~001~AP~Aug 4, 1988~Yes~RX~HOSPIRA INC
Q 500MG BASE/VIAL~A~062931~001~AP~Oct 29, 1992~Yes~RX~HOSPIRA INC
Q 750MG BASE/VIAL~A~062912~002~AP~Jan 7, 2009~Yes~RX~HOSPIRA INC
Q 750MG BASE/VIAL~A~062933~002~AP~May 27, 2009~Yes~RX~HOSPIRA INC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~HOSPIRA I
NC~EQ 10GM BASE/VIAL~A~065455~001~AP~Apr 29, 2009~No~RX~HOSPIRA INC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~MUSTAFA N
EVZAT ILAC~EQ 1GM BASE/VIAL~A~065401~002~AP~Jun 30, 2008~No~RX~MUSTAFA NEVZAT IL
AC SANAYII AS (MN PHARMACEUTICALS)
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~MUSTAFA N
EVZAT ILAC~EQ 500MG BASE/VIAL~A~065401~001~AP~Jun 30, 2008~No~RX~MUSTAFA NEVZAT
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~SAGENT PH
ARMS~EQ 5GM BASE/VIAL~A~200837~001~AP~Aug 10, 2012~No~RX~SAGENT PHARMACEUTICALS
INC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~SAGENT PH

ARMS~EQ 10GM BASE/VIAL~A~200837~002~AP~Sep 2, 2014~No~RX~SAGENT PHARMACEUTICALS
INC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~SANDOZ~EQ
1GM BASE/VIAL~A~090250~002~AP~Apr 27, 2010~No~RX~SANDOZ INC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~SANDOZ~EQ
500MG BASE/VIAL~A~090250~001~AP~Apr 27, 2010~No~RX~SANDOZ INC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~SANDOZ IN
C~EQ 5GM BASE/VIAL~A~201048~001~AP~Aug 10, 2012~No~RX~SANDOZ INC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOMYCIN HYDROCHLORIDE~SANDOZ IN
C~EQ 10GM BASE/VIAL~A~201048~002~AP~Aug 10, 2012~No~RX~SANDOZ INC
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOR~PHARMACIA AND UPJOHN~EQ 1GM
BASE/VIAL~A~062956~002~~Aug 1, 1988~No~DISCN~PHARMACIA AND UPJOHN CO
VANCOMYCIN HYDROCHLORIDE~INJECTABLE;INJECTION~VANCOR~PHARMACIA AND UPJOHN~EQ 500
MG BASE/VIAL~A~062956~001~~Aug 1, 1988~No~DISCN~PHARMACIA AND UPJOHN CO
IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM~INJECTABLE;INJECTION~VASCORAY~MALLINCK
RODT~52%;26%~N~016783~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT M
EDICAL INC
ENALAPRILAT~INJECTABLE;INJECTION~VASOTEC~BIOVAIL LABS INTL~1.25MG/ML~N~019309~00
1~~Feb 9, 1988~No~DISCN~BIOVAIL LABORATORIES INTERNATIONAL SRL
METHOXAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~VASOXYL~GLAXOSMITHKLINE~10MG/ML~N
METHOXAMINE HYDROCHLORIDE~INJECTABLE;INJECTION~VASOXYL~GLAXOSMITHKLINE~20MG/ML~N
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~AGILA SPECLTS~10MG/VI
AL~A~090243~001~AP~May 11, 2010~No~RX~AGILA SPECIALTIES PRIVATE LTD
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~AGILA SPECLTS~20MG/VI
AL~A~090243~002~AP~May 11, 2010~No~RX~AGILA SPECIALTIES PRIVATE LTD
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~BEDFORD~10MG/VIAL~A~0
75549~001~AP~Jun 13, 2000~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES
INC
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~BEDFORD~20MG/VIAL~A~0
75549~002~AP~Jun 13, 2000~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES
INC
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~HIKMA MAPLE ~10MG/VIA
L~A~075218~001~~Aug 23, 1999~No~DISCN~HIKMA MAPLE LTD
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~HIKMA MAPLE ~20MG/VIA
L~A~075218~002~~Aug 23, 1999~No~DISCN~HIKMA MAPLE LTD
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~HOSPIRA~4MG/VIAL~A~07
5558~001~~Sep 11, 2001~No~DISCN~HOSPIRA INC
75164~001~AP~Oct 21, 1999~No~RX~HOSPIRA INC
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~MUSTAFA NEVZAT~10MG/V
IAL~A~078274~001~AP~Dec 29, 2008~No~RX~MUSTAFA NEVZAT ILAC SANAYII AS
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~MUSTAFA NEVZAT~20MG/V
IAL~A~078274~002~AP~Dec 29, 2008~No~RX~MUSTAFA NEVZAT ILAC SANAYII AS
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~SUN PHARMA GLOBAL~10M
G/VIAL~A~079001~001~AP~Jun 17, 2009~Yes~RX~SUN PHARMA GLOBAL FZE
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~SUN PHARMA GLOBAL~20M
G/VIAL~A~079001~002~AP~Jun 17, 2009~Yes~RX~SUN PHARMA GLOBAL FZE
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~TEVA PHARMS USA~10MG/
VIAL~A~074688~001~AP~Aug 25, 1999~No~RX~TEVA PHARMACEUTICALS USA
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~TEVA PHARMS USA~20MG/
VIAL~A~074688~002~AP~Aug 25, 1999~No~RX~TEVA PHARMACEUTICALS USA
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~WATSON LABS~10MG/VIAL
VECURONIUM BROMIDE~INJECTABLE;INJECTION~VECURONIUM BROMIDE~WATSON LABS~20MG/VIAL
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM A

CETATE~INJECTABLE;INJECTION~VEINAMINE 8%~HOSPIRA INC~8%;61MG/100ML;211MG/100ML;5
6MG/100ML;388MG/100ML~N~017957~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPI
RA INC
VINBLASTINE SULFATE~INJECTABLE;INJECTION~VELBAN~LILLY~10MG/VIAL~N~012665~001~~Ap
EPOPROSTENOL SODIUM~INJECTABLE;INJECTION~VELETRI~ACTELION PHARMS LTD~EQ 0.5MG BA
SE/VIAL~N~022260~002~~Jun 28, 2012~No~RX~ACTELION PHARMACEUTICALS LTD
EPOPROSTENOL SODIUM~INJECTABLE;INJECTION~VELETRI~ACTELION PHARMS LTD~EQ 1.5MG BA
SE/VIAL~N~022260~001~~Jun 27, 2008~Yes~RX~ACTELION PHARMACEUTICALS LTD
CEPHRADINE~INJECTABLE;INJECTION~VELOSEF~APOTHECON~1GM/VIAL~A~061976~004~~Approve
CEPHRADINE~INJECTABLE;INJECTION~VELOSEF~APOTHECON~250MG/VIAL~A~061976~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CEPHRADINE~INJECTABLE;INJECTION~VELOSEF~APOTHECON~500MG/VIAL~A~061976~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
INSULIN PURIFIED PORK~INJECTABLE;INJECTION~VELOSULIN~NOVO NORDISK INC~100 UNITS/
ML~N~018193~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVO NORDISK INC
INSULIN RECOMBINANT HUMAN~INJECTABLE;INJECTION~VELOSULIN BR~NOVO NORDISK INC~100
UNITS/ML~N~021028~001~~Jul 19, 1999~No~DISCN~NOVO NORDISK INC
INSULIN RECOMBINANT PURIFIED HUMAN~INJECTABLE;INJECTION~VELOSULIN BR HUMAN~NOVO
NORDISK INC~100 UNITS/ML~N~019450~001~~May 30, 1986~No~DISCN~NOVO NORDISK INC
ETOPOSIDE~INJECTABLE;INJECTION~VEPESID~CORDEN PHARMA~20MG/ML~N~018768~001~~Nov 1
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~ABRAXIS PHA
RM~2.5MG/ML~A~070348~001~~May 1, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~BEDFORD~2.5
MG/ML~A~072888~001~~Jul 28, 1995~No~DISCN~BEDFORD LABORATORIES DIV BEN VENUE LAB
ORATORIES INC
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~HOSPIRA~2.5
MG/ML~A~070577~001~~Feb 2, 1987~No~DISCN~HOSPIRA WORLDWIDE, INC
MG/ML~A~070739~001~~May 6, 1987~No~DISCN~HOSPIRA INC
MG/ML~A~070740~001~~May 6, 1987~No~DISCN~HOSPIRA INC
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~INTL MEDICA
TION~2.5MG/ML~A~070451~001~~Dec 16, 1985~No~DISCN~INTERNATIONAL MEDICATION SYSTE
M
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~LUITPOLD~2.
5MG/ML~A~070225~001~~Nov 12, 1985~No~DISCN~LUITPOLD PHARMACEUTICALS INC
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~LUITPOLD~2.
5MG/ML~A~070617~001~~Nov 12, 1985~No~DISCN~LUITPOLD PHARMACEUTICALS INC
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~MARSAM PHAR
MS LLC~2.5MG/ML~A~072233~001~~Feb 26, 1993~No~DISCN~MARSAM PHARMACEUTICALS LLC
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~MARSAM PHAR
MS LLC~2.5MG/ML~A~073485~001~~Sep 27, 1993~No~DISCN~MARSAM PHARMACEUTICALS LLC
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~SMITH AND N
EPHEW~2.5MG/ML~A~070696~001~~Jul 31, 1987~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV
SMITH AND NEPHEW
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~SMITH AND N
EPHEW~2.5MG/ML~A~070697~001~~Jul 31, 1987~No~DISCN~SMITH AND NEPHEW SOLOPAK DIV
SMITH AND NEPHEW
VERAPAMIL HYDROCHLORIDE~INJECTABLE;INJECTION~VERAPAMIL HYDROCHLORIDE~SOLOPAK~2.5
MG/ML~A~070695~001~~Jul 31, 1987~No~DISCN~SOLOPAK MEDICAL PRODUCTS INC
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~VERSED~HLR~EQ 1MG BASE/ML~N~018654~
002~~May 26, 1987~No~DISCN~HLR TECHNOLOGY
MIDAZOLAM HYDROCHLORIDE~INJECTABLE;INJECTION~VERSED~HLR~EQ 5MG BASE/ML~N~018654~

001~~Dec 20, 1985~No~DISCN~HLR TECHNOLOGY
TRIFLUPROMAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~VESPRIN~APOTHECON~3MG/ML~N~01
SQUIBB
S SQUIBB
S SQUIBB
CYANOCOBALAMIN~INJECTABLE;INJECTION~VI-TWEL~BAYER HLTHCARE~1MG/ML~N~007012~002~~
Approved Prior to Jan 1, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
CYANOCOBALAMIN~INJECTABLE;INJECTION~VIBISONE~FRESENIUS KABI USA~1MG/ML~A~080557~
003~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~VIBRAMYCIN~PFIZER~EQ 100MG BASE/VIAL~N~
R INC
DOXYCYCLINE HYCLATE~INJECTABLE;INJECTION~VIBRAMYCIN~PFIZER~EQ 200MG BASE/VIAL~N~
R INC
VINBLASTINE SULFATE~INJECTABLE;INJECTION~VINBLASTINE SULFATE~ABRAXIS PHARM~10MG/
VIAL~A~089011~001~~Nov 18, 1985~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
VINBLASTINE SULFATE~INJECTABLE;INJECTION~VINBLASTINE SULFATE~EUROHLTH INTL SARL~
10MG/VIAL~A~089395~001~~Apr 9, 1987~Yes~RX~EUROHEALTH INTERNATIONAL SARL
VINBLASTINE SULFATE~INJECTABLE;INJECTION~VINBLASTINE SULFATE~FRESENIUS KABI USA~
1MG/ML~A~089515~001~~Apr 29, 1987~Yes~RX~FRESENIUS KABI USA LLC
VINBLASTINE SULFATE~INJECTABLE;INJECTION~VINBLASTINE SULFATE~HOSPIRA~10MG/VIAL~A
~089565~001~~Aug 18, 1987~No~DISCN~HOSPIRA INC
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCASAR PFS~TEVA PARENTERAL~1MG/ML~A~0
71426~001~~Jul 17, 1987~No~DISCN~TEVA PARENTERAL MEDICINES INC
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCREX~BRISTOL MYERS SQUIBB~5MG/VIAL~A
~070867~001~~Jul 12, 1988~No~DISCN~BRISTOL MYERS SQUIBB
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCRISTINE SULFATE~ABIC~1MG/ML~A~07087
3~001~~Feb 19, 1987~No~DISCN~ABIC LTD
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCRISTINE SULFATE~ABRAXIS PHARM~1MG/M
L~A~070411~001~~Sep 10, 1986~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCRISTINE SULFATE~FRESENIUS KABI USA~
1MG/ML~A~076296~001~~Dec 20, 2002~No~DISCN~FRESENIUS KABI USA LLC
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCRISTINE SULFATE~FRESENIUS KABI USA~
1MG/ML~A~076401~001~~Oct 28, 2003~No~DISCN~FRESENIUS KABI USA LLC
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCRISTINE SULFATE~HOSPIRA~1MG/VIAL~A~
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCRISTINE SULFATE PFS~HOSPIRA~1MG/ML~
A~071484~001~AP~Apr 19, 1988~Yes~RX~HOSPIRA WORLDWIDE, INC
VINCRISTINE SULFATE~INJECTABLE;INJECTION~VINCRISTINE SULFATE PFS~TEVA PHARMS USA
~1MG/ML~A~075493~001~AP~Sep 1, 1999~No~RX~TEVA PHARMACEUTICALS USA
VINORELBINE~INJECTABLE;INJECTION~VINORELBINE~ONCO THERAPIES LTD~EQ 10MG BASE/ML~
A~200148~001~AP~Aug 31, 2012~No~RX~ONCO THERAPIES LTD
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~ACTAVIS TOTOWA~EQ
10MG BASE/ML~A~078011~001~AP~Jul 22, 2009~No~RX~ACTAVIS TOTOWA LLC
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~BEDFORD~EQ 10MG B
ASE/ML~A~076461~001~AP~Dec 11, 2003~No~RX~BEDFORD LABORATORIES DIV BEN VENUE LAB
ORATORIES INC
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~DR REDDYS LABS LT
D~EQ 10MG BASE/ML~A~202017~001~AP~Sep 12, 2013~No~RX~DR REDDYS LABORATORIES LTD
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~EBEWE PHARMA~EQ 1

0MG BASE/ML~A~078408~001~~Feb 13, 2008~No~DISCN~EBEWE PHARMA GES MBH NFG KG
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~FRESENIUS KABI US
A~EQ 10MG BASE/ML~A~076849~001~AP~Apr 18, 2005~No~RX~FRESENIUS KABI USA LLC
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~HIKMA MAPLE ~EQ 1
0MG BASE/ML~A~075992~001~AP~Jun 10, 2003~No~RX~HIKMA MAPLE LTD
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~HOSPIRA~EQ 10MG B
ASE/ML~A~076827~001~AP~Jun 2, 2005~No~RX~HOSPIRA INC
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~JIANGSU HANSOH PH
ARM~EQ 10MG BASE/ML~A~091106~001~AP~Sep 26, 2012~No~RX~JIANGSU HANSOH PHARMACEUT
ICAL CO LTD
VINORELBINE TARTRATE~INJECTABLE;INJECTION~VINORELBINE TARTRATE~TEVA PHARMS USA~E
Q 10MG BASE/ML~A~076028~001~AP~Feb 3, 2003~No~RX~TEVA PHARMACEUTICALS USA
VIOMYCIN SULFATE~INJECTABLE;INJECTION~VIOCIN SULFATE~PFIZER~EQ 1GM BASE/VIAL~A~0
61086~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER
INC
VIOMYCIN SULFATE~INJECTABLE;INJECTION~VIOCIN SULFATE~PFIZER~EQ 5GM BASE/VIAL~A~0
61086~002~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER
INC
VIDARABINE~INJECTABLE;INJECTION~VIRA-A~PARKEDALE~EQ 187.4MG BASE/ML~N~050523~001
~~Approved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
IODIXANOL~INJECTABLE;INJECTION~VISIPAQUE 270~GE HEALTHCARE~55%~N~020351~001~~Mar
22, 1996~Yes~RX~GE HEALTHCARE
IODIXANOL~INJECTABLE;INJECTION~VISIPAQUE 270~GE HEALTHCARE~55%~N~020808~001~~Aug
29, 1997~No~RX~GE HEALTHCARE
IODIXANOL~INJECTABLE;INJECTION~VISIPAQUE 320~GE HEALTHCARE~65.2%~N~020351~002~~M
ar 22, 1996~Yes~RX~GE HEALTHCARE
IODIXANOL~INJECTABLE;INJECTION~VISIPAQUE 320~GE HEALTHCARE~65.2%~N~020808~002~~A
ug 29, 1997~No~RX~GE HEALTHCARE
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~VISTARIL~PFIZER~25MG/ML~N~011111~
HYDROXYZINE HYDROCHLORIDE~INJECTABLE;INJECTION~VISTARIL~PFIZER~50MG/ML~N~011111~
CIDOFOVIR~INJECTABLE;INJECTION~VISTIDE~GILEAD SCIENCES INC~EQ 75MG BASE/ML~N~020
638~001~AP~Jun 26, 1996~Yes~RX~GILEAD SCIENCES INC
VERTEPORFIN~INJECTABLE;INJECTION~VISUDYNE~VALEANT PHARMS INC~15MG/VIAL~N~021119~
001~~Apr 12, 2000~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL INC
VITAMIN A PALMITATE~INJECTABLE;INJECTION~VITAMIN A PALMITATE~BEL MAR~EQ 50,000 U
NITS BASE/ML~A~080819~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEL MAR LABORA
TORIES INC
PHYTONADIONE~INJECTABLE;INJECTION~VITAMIN K1~HOSPIRA~1MG/0.5ML~A~087954~001~BP~J
ul 25, 1983~Yes~RX~HOSPIRA INC
PHYTONADIONE~INJECTABLE;INJECTION~VITAMIN K1~HOSPIRA~10MG/ML~A~087955~001~~Jul 2
PHYTONADIONE~INJECTABLE;INJECTION~VITAMIN K1~HOSPIRA~10MG/ML~A~087956~001~~Jul 2
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PANTOTHENIC ACID; PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALM
ITATE; VITAMIN E~INJECTABLE;INJECTION~VITAPED~HOSPIRA~N/A,80MG/VIAL;N/A,0.02MG/V
IAL;N/A,0.001MG/VIAL;400 IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VIAL;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/10
ML,N/A;7 IU/10ML,N/A~N~020176~001~~Dec 29, 1993~No~DISCN~HOSPIRA INC
HYALURONIDASE~INJECTABLE;INJECTION~VITRASE~BAUSCH AND LOMB~200 UNITS/VIAL~N~0216
40~002~~Dec 2, 2004~Yes~RX~BAUSCH AND LOMB INC
HYALURONIDASE~INJECTABLE;INJECTION~VITRASE~BAUSCH AND LOMB~6,200 UNITS/VIAL~N~02
1640~001~~May 5, 2004~No~DISCN~BAUSCH AND LOMB INC
FOMIVIRSEN SODIUM~INJECTABLE;INJECTION~VITRAVENE PRESERVATIVE FREE~NOVARTIS~6.6M
G/ML~N~020961~001~~Aug 26, 1998~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
TENIPOSIDE~INJECTABLE;INJECTION~VUMON~HQ SPECLT PHARMA~10MG/ML~N~020119~001~~Jul
14, 1992~Yes~RX~HQ SPECIALTY PHARMA
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~WELLCOVORIN~GLAXOSMITHKLINE~EQ 5MG BASE/

ML~A~087439~001~~Oct 19, 1982~No~DISCN~GLAXOSMITHKLINE
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~WELLCOVORIN~GLAXOSMITHKLINE~EQ 25MG BASE
/VIAL~A~089833~001~~Jan 23, 1989~No~DISCN~GLAXOSMITHKLINE
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~WELLCOVORIN~GLAXOSMITHKLINE~EQ 50MG BASE
/VIAL~A~089465~001~~Jan 23, 1989~No~DISCN~GLAXOSMITHKLINE
LEUCOVORIN CALCIUM~INJECTABLE;INJECTION~WELLCOVORIN~GLAXOSMITHKLINE~EQ 100MG BAS
E/VIAL~A~089834~001~~Jan 23, 1989~No~DISCN~GLAXOSMITHKLINE
MEPHENTERMINE SULFATE~INJECTABLE;INJECTION~WYAMINE SULFATE~BAXTER HLTHCARE CORP~
EQ 15MG BASE/ML~N~008248~002~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEAL
THCARE CORP ANESTHESIA CRITICAL CARE
MEPHENTERMINE SULFATE~INJECTABLE;INJECTION~WYAMINE SULFATE~BAXTER HLTHCARE CORP~
EQ 30MG BASE/ML~N~008248~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEAL
THCARE CORP ANESTHESIA CRITICAL CARE
HYALURONIDASE~INJECTABLE;INJECTION~WYDASE~BAXTER HLTHCARE~150 UNITS/ML~N~006343~
002~~Approved Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP ANESTHESIA AN
D CRITICAL CARE
HYALURONIDASE~INJECTABLE;INJECTION~WYDASE~BAXTER HLTHCARE~150 UNITS/VIAL **Feder
ety or efficacy reasons**~N~006343~006~~Approved Prior to Jan 1, 1982~No~DISCN~B
AXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
HYALURONIDASE~INJECTABLE;INJECTION~WYDASE~BAXTER HLTHCARE~1,500 UNITS/VIAL **Fed
~BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
XENON XE-133~INJECTABLE;INJECTION~XENON XE 133~GE HEALTHCARE~1.3-1.7 CI/AMP~N~01
XENON XE-133~INJECTABLE;INJECTION~XENON XE 133~LANTHEUS MEDCL~6.3mCi/ML~N~017283
~001~~Approved Prior to Jan 1, 1982~No~DISCN~LANTHEUS MEDICAL IMAGING INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE~ASTRAZENECA~1%~N~010418~0
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE~ASTRAZENECA~1.5%~N~010418
~009~~Approved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA LP
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE~ASTRAZENECA~2%~N~010418~0
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE~FRESENIUS KABI USA~0.5%~N
~006488~008~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE~FRESENIUS KABI USA~1%~N~0
06488~007~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE~FRESENIUS KABI USA~1.5%~N
~006488~010~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE~FRESENIUS KABI USA~2%~N~0
06488~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE 4% PRESERVATIVE FREE~FRES
ENIUS KABI USA~4%~N~010417~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS
KABI USA LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE DENTAL~DENTSPLY PHARM~2%~
N~021380~001~~Approved Prior to Jan 1, 1982~No~DISCN~DENTSPLY PHARMACEUTICAL INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE DENTAL WITH
EPINEPHRINE~DENTSPLY PHARM~0.01MG/ML;2%~N~021381~001~~Approved Prior to Jan 1, 1
982~No~DISCN~DENTSPLY PHARMACEUTICAL INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE DENTAL WITH
EPINEPHRINE~DENTSPLY PHARM~0.02MG/ML;2%~N~021381~002~~Approved Prior to Jan 1, 1
982~No~DISCN~DENTSPLY PHARMACEUTICAL INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE PRESERVATIVE FREE~FRESENI
US KABI USA~1%~N~016801~005~AP~Jan 19, 1988~Yes~RX~FRESENIUS KABI USA LLC
US KABI USA~2%~N~016801~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KA
BI USA LLC
US KABI USA~4%~N~016801~002~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KA

BI USA LLC
US KABI USA~10%~N~016801~003~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS K
ABI USA LLC
US KABI USA~20%~N~016801~004~AP~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS K
ABI USA LLC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~INJECTABLE;INJECTION~XYLOCAINE W/ EPINEPHRI
NE~ASTRAZENECA~0.005MG/ML;1%~N~010418~006~~Approved Prior to Jan 1, 1982~No~DISC
N~ASTRAZENECA LP
NE~ASTRAZENECA~0.005MG/ML;1.5%~N~010418~010~~Approved Prior to Jan 1, 1982~No~DI
SCN~ASTRAZENECA LP
NE~ASTRAZENECA~0.005MG/ML;2%~N~010418~008~~Approved Prior to Jan 1, 1982~No~DISC
N~ASTRAZENECA LP
NE~FRESENIUS KABI USA~0.005MG/ML;0.5%~N~006488~012~AP~Approved Prior to Jan 1, 1
982~Yes~RX~FRESENIUS KABI USA LLC
NE~FRESENIUS KABI USA~0.005MG/ML;1%~N~006488~018~AP~Nov 13, 1986~Yes~RX~FRESENIU
S KABI USA LLC
NE~FRESENIUS KABI USA~0.005MG/ML;1.5%~N~006488~017~AP~Approved Prior to Jan 1, 1
982~Yes~RX~FRESENIUS KABI USA LLC
NE~FRESENIUS KABI USA~0.005MG/ML;2%~N~006488~019~AP~Nov 13, 1986~Yes~RX~FRESENIU
S KABI USA LLC
NE~FRESENIUS KABI USA~0.01MG/ML;1%~N~006488~004~AP~Approved Prior to Jan 1, 1982
~Yes~RX~FRESENIUS KABI USA LLC
NE~FRESENIUS KABI USA~0.01MG/ML;2%~N~006488~003~~Approved Prior to Jan 1, 1982~N
o~DISCN~FRESENIUS KABI USA LLC
NE~FRESENIUS KABI USA~0.02MG/ML;2%~N~006488~005~AP~Approved Prior to Jan 1, 1982
~Yes~RX~FRESENIUS KABI USA LLC
PENTETATE CALCIUM TRISODIUM YB-169~INJECTABLE;INJECTION~YTTERBIUM YB 169 DTPA~3M
~2mCi/ML~N~017518~001~~Approved Prior to Jan 1, 1982~No~DISCN~3M MEDICAL PRODUCT
S DIV
RITODRINE HYDROCHLORIDE~INJECTABLE;INJECTION~YUTOPAR~ASTRAZENECA~10MG/ML~N~01858
RITODRINE HYDROCHLORIDE~INJECTABLE;INJECTION~YUTOPAR~ASTRAZENECA~15MG/ML~N~01858
STREPTOZOCIN~INJECTABLE;INJECTION~ZANOSAR~TEVA PHARMS USA~1GM/VIAL~N~050577~001~
~May 7, 1982~Yes~RX~TEVA PHARMACEUTICALS USA
RANITIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~ZANTAC~COVIS INJECTABLES~EQ 25MG B
ASE/ML~N~019090~001~AP~Oct 19, 1984~Yes~RX~COVIS INJECTABLES SARL
RANITIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~ZANTAC IN PLASTIC CONTAINER~COVIS
INJECTABLES~EQ 1MG BASE/ML~N~019593~002~~Sep 27, 1991~No~DISCN~COVIS INJECTABLES
SARL
RANITIDINE HYDROCHLORIDE~INJECTABLE;INJECTION~ZANTAC IN PLASTIC CONTAINER~COVIS
INJECTABLES~EQ 50MG BASE/100ML~N~019593~001~~Dec 17, 1986~No~DISCN~COVIS INJECTA
BLES SARL
CEFMETAZOLE SODIUM~INJECTABLE;INJECTION~ZEFAZONE~PHARMACIA AND UPJOHN~EQ 1GM BAS
E/VIAL~N~050637~001~~Dec 11, 1989~No~DISCN~PHARMACIA AND UPJOHN CO
CEFMETAZOLE SODIUM~INJECTABLE;INJECTION~ZEFAZONE~PHARMACIA AND UPJOHN~EQ 2GM BAS
E/VIAL~N~050637~002~~Dec 11, 1989~No~DISCN~PHARMACIA AND UPJOHN CO
CEFMETAZOLE SODIUM~INJECTABLE;INJECTION~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**~N~050683~001~~Dec 29
, 1992~No~DISCN~PHARMACIA AND UPJOHN CO
CEFMETAZOLE SODIUM~INJECTABLE;INJECTION~ZEFAZONE IN PLASTIC CONTAINER~PHARMACIA
AND UPJOHN~EQ 40MG BASE/ML **Federal Register determination that product was not
discontinued or withdrawn for safety or efficacy reasons**~N~050683~002~~Dec 29
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ZEMURON~ORGANON USA INC~50MG/5ML (10MG/M
L) **Federal Register determination that product was not discontinued or withdra
wn for safety or efficacy reasons**~N~020214~001~~Mar 17, 1994~No~DISCN~ORGANON
USA INC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ZEMURON~ORGANON USA INC~10MG/ML (10MG/ML
) **Federal Register determination that product was not discontinued or withdraw
n for safety or efficacy reasons**~N~020214~002~~Mar 17, 1994~No~DISCN~ORGANON U
SA INC
ROCURONIUM BROMIDE~INJECTABLE;INJECTION~ZEMURON~ORGANON USA INC~100MG/10ML (10MG
/ML) **Federal Register determination that product was not discontinued or withd
rawn for safety or efficacy reasons**~N~020214~003~~Mar 17, 1994~No~DISCN~ORGANO
N USA INC
ZIDOVUDINE~INJECTABLE;INJECTION~ZIDOVUDINE~LIAONING CHENGDA~10MG/ML~A~204538~001
~~Nov 26, 2013~No~DISCN~LIAONING CHENGDA BIOTECHNOLOGY CO LTD
ZIDOVUDINE~INJECTABLE;INJECTION~ZIDOVUDINE~LUITPOLD~10MG/ML~A~091457~001~AP~May
6, 2010~No~RX~LUITPOLD PHARMACEUTICALS INC
CEFUROXIME SODIUM~INJECTABLE;INJECTION~ZINACEF~COVIS INJECTABLES~EQ 1.5GM BASE/V
IAL~N~050558~003~AP~Oct 19, 1983~Yes~RX~COVIS INJECTABLES SARL
CEFUROXIME SODIUM~INJECTABLE;INJECTION~ZINACEF~COVIS INJECTABLES~EQ 7.5GM BASE/V
IAL~N~050558~004~AP~Oct 23, 1986~Yes~RX~COVIS INJECTABLES SARL
CEFUROXIME SODIUM~INJECTABLE;INJECTION~ZINACEF IN PLASTIC CONTAINER~COVIS INJECT
ABLES~EQ 15MG BASE/ML~N~050643~001~~Apr 28, 1989~No~DISCN~COVIS INJECTABLES SARL
CEFUROXIME SODIUM~INJECTABLE;INJECTION~ZINACEF IN PLASTIC CONTAINER~COVIS INJECT
ZINC CHLORIDE~INJECTABLE;INJECTION~ZINC CHLORIDE IN PLASTIC CONTAINER~HOSPIRA~EQ
1MG ZINC/ML~N~018959~001~~Jun 26, 1986~Yes~RX~HOSPIRA INC
ZINC SULFATE~INJECTABLE;INJECTION~ZINC SULFATE~ABRAXIS PHARM~EQ 1MG ZINC/ML~N~01
9229~002~~May 5, 1987~No~DISCN~ABRAXIS PHARMACEUTICAL PRODUCTS
DEXRAZOXANE HYDROCHLORIDE~INJECTABLE;INJECTION~ZINECARD~PHARMACIA AND UPJOHN~EQ
250MG BASE/VIAL~N~020212~001~AP~May 26, 1995~Yes~RX~PHARMACIA AND UPJOHN CO
DEXRAZOXANE HYDROCHLORIDE~INJECTABLE;INJECTION~ZINECARD~PHARMACIA AND UPJOHN~EQ
500MG BASE/VIAL~N~020212~002~AP~May 26, 1995~Yes~RX~PHARMACIA AND UPJOHN CO
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~ZIPAN-25~ALTANA~25MG/ML~A~083997
~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALTANA INC
PROMETHAZINE HYDROCHLORIDE~INJECTABLE;INJECTION~ZIPAN-50~ALTANA~50MG/ML~A~083997
~002~~Approved Prior to Jan 1, 1982~No~DISCN~ALTANA INC
AZITHROMYCIN~INJECTABLE;INJECTION~ZITHROMAX~PFIZER~EQ 500MG BASE/VIAL~N~050733~0
01~AP~Jan 30, 1997~Yes~RX~PFIZER INC
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ZOFRAN~GLAXOSMITHKLINE~EQ 2MG BAS
E/ML~N~020007~001~AP~Jan 4, 1991~Yes~RX~GLAXOSMITHKLINE
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ZOFRAN AND DEXTROSE IN PLASTIC CO
NTAINER~GLAXOSMITHKLINE~EQ 0.64MG BASE/ML~N~020403~001~~Jan 31, 1995~No~DISCN~GL
AXOSMITHKLINE
ONDANSETRON HYDROCHLORIDE~INJECTABLE;INJECTION~ZOFRAN PRESERVATIVE FREE~GLAXOSMI
THKLINE~EQ 2MG BASE/ML~N~020007~003~AP~Dec 10, 1993~Yes~RX~GLAXOSMITHKLINE
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~ZORBTIVE~EMD SERONO~4MG/VIAL~N~02159
7~001~~Dec 1, 2003~No~DISCN~EMD SERONO INC
SOMATROPIN RECOMBINANT~INJECTABLE;INJECTION~ZORBTIVE~EMD SERONO~8.8MG/VIAL~N~021
597~004~~Dec 1, 2003~Yes~RX~EMD SERONO INC
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM~INJECTABLE;INJECTION~ZOSYN~WYETH PHARMS I

NC~EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL~N~050684~001~AP~Oct 22, 1993~Yes~RX~WYETH
PHARMACEUTICALS INC
PHARMACEUTICALS INC
PHARMACEUTICALS INC
NC~EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL~N~050684~004~AP~Oct 22, 1993~Yes~RX~WYET
H PHARMACEUTICALS INC
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM~INJECTABLE;INJECTION~ZOSYN IN PLASTIC CON
TAINER~WYETH PHARMS INC~EQ 4GM BASE/100ML;EQ 500MG BASE/100ML~N~050750~003~~Feb
24, 1998~Yes~RX~WYETH PHARMACEUTICALS INC
TAINER~WYETH PHARMS INC~EQ 40MG BASE/ML;EQ 5MG BASE/ML~N~050750~001~~Feb 24, 199
8~Yes~RX~WYETH PHARMACEUTICALS INC
TAINER~WYETH PHARMS INC~EQ 60MG BASE/ML;EQ 7.5MG BASE/ML~N~050750~002~~Feb 24, 1
998~Yes~RX~WYETH PHARMACEUTICALS INC
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ZOVIRAX~GLAXOSMITHKLINE~EQ 1GM BASE/VIAL *
*Federal Register determination that product was not discontinued or withdrawn f
or safety or efficacy reasons**~N~018603~002~~Jun 29, 1989~No~DISCN~GLAXOSMITHKL
INE
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ZOVIRAX~GLAXOSMITHKLINE~EQ 250MG BASE/VIAL
for safety or efficacy reasons**~N~018603~003~~Aug 30, 1983~No~DISCN~GLAXOSMITH
KLINE
ACYCLOVIR SODIUM~INJECTABLE;INJECTION~ZOVIRAX~GLAXOSMITHKLINE~EQ 500MG BASE/VIAL
for safety or efficacy reasons**~N~018603~001~~Oct 22, 1982~No~DISCN~GLAXOSMITH
KLINE
LINEZOLID~INJECTABLE;INJECTION~ZYVOX~PHARMACIA AND UPJOHN~200MG/100ML~N~021131~0
01~AP~Apr 18, 2000~Yes~RX~PHARMACIA AND UPJOHN CO
TRIAMCINOLONE ACETONIDE~INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL~
TRIVARIS~ALLERGAN~8MG/0.1ML (8MG/0.1ML)~N~022220~001~~Jun 16, 2008~No~DISCN~ALLE
RGAN INC
ARIPIPRAZOLE~INJECTABLE;INTRAMUSCULAR~ABILIFY~OTSUKA~9.75MG/1.3ML (7.5MG/ML)~N~0
21866~001~~Sep 20, 2006~Yes~RX~OTSUKA PHARMACEUTICAL CO LTD
ATROPINE; PRALIDOXIME CHLORIDE~INJECTABLE;INTRAMUSCULAR~ATNAA~US ARMY~2.1MG/0.7M
L;600MG/0.7ML~N~021175~001~~Jan 17, 2002~No~DISCN~US ARMY MEDICAL RESEARCH MATER
IEL COMMAND
TESTOSTERONE UNDECANOATE~INJECTABLE;INTRAMUSCULAR~AVEED~ENDO PHARMS INC~750MG/3M
L (250MG/ML)~N~022219~001~~Mar 4, 2014~Yes~RX~ENDO PHARMACEUTICALS INC
ATROPINE; PRALIDOXIME CHLORIDE~INJECTABLE;INTRAMUSCULAR~DUODOTE~MERIDIAN MEDCL~2
.1MG/0.7ML;600MG/2ML~N~021983~001~~Sep 28, 2006~Yes~RX~MERIDIAN MEDICAL TECHNOLO
GIES INC
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR~EPI E Z PEN JR~MYLAN SPECLT~0.15MG/DELIVERY
~N~019430~004~~Aug 3, 1995~No~DISCN~MYLAN SPECIALTY LP
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR~EPIPEN E Z PEN~MYLAN SPECLT~0.3MG/DELIVERY~
N~019430~003~~Aug 3, 1995~No~DISCN~MYLAN SPECIALTY LP
FULVESTRANT~INJECTABLE;INTRAMUSCULAR~FASLODEX~ASTRAZENECA~50MG/ML~N~021344~001~~
Apr 25, 2002~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
ZIPRASIDONE MESYLATE~INJECTABLE;INTRAMUSCULAR~GEODON~PFIZER~EQ 20MG BASE/ML~N~02
0919~001~~Jun 21, 2002~Yes~RX~PFIZER INC
ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE~INJECTABLE;INTRAMUSCULAR~LUNELL
E~PHARMACIA AND UPJOHN~5MG/0.5ML;25MG/0.5ML~N~020874~001~~Oct 5, 2000~No~DISCN~P
HARMACIA AND UPJOHN CO
UROFOLLITROPIN~INJECTABLE;INTRAMUSCULAR~METRODIN~SERONO~75 IU/AMP~N~019415~002~~
Sep 18, 1986~No~DISCN~SERONO LABORATORIES INC

UROFOLLITROPIN~INJECTABLE;INTRAMUSCULAR~METRODIN~SERONO~150 IU/AMP~N~019415~003~
~Sep 18, 1986~No~DISCN~SERONO LABORATORIES INC
OLANZAPINE~INJECTABLE;INTRAMUSCULAR~OLANZAPINE~LUITPOLD~10MG/VIAL~A~201741~001~A
P~Mar 20, 2012~No~RX~LUITPOLD PHARMACEUTICALS INC
OLANZAPINE~INJECTABLE;INTRAMUSCULAR~OLANZAPINE~SANDOZ INC~10MG/VIAL~A~201588~001
~AP~Oct 24, 2011~No~RX~SANDOZ INC
ABARELIX~INJECTABLE;INTRAMUSCULAR~PLENAXIS~SPECIALITY EUROPEAN~100MG/VIAL~N~0213
20~001~~Nov 25, 2003~No~DISCN~SPECIALITY EUROPEAN PHARMA LTD
RISPERIDONE~INJECTABLE;INTRAMUSCULAR~RISPERDAL CONSTA~JANSSEN PHARMS~12.5MG/VIAL
~N~021346~004~~Apr 12, 2007~No~RX~JANSSEN PHARMACEUTICALS INC
RISPERIDONE~INJECTABLE;INTRAMUSCULAR~RISPERDAL CONSTA~JANSSEN PHARMS~25MG/VIAL~N
~021346~001~~Oct 29, 2003~Yes~RX~JANSSEN PHARMACEUTICALS INC
RISPERIDONE~INJECTABLE;INTRAMUSCULAR~RISPERDAL CONSTA~JANSSEN PHARMS~37.5MG/VIAL
~N~021346~002~~Oct 29, 2003~No~RX~JANSSEN PHARMACEUTICALS INC
RISPERIDONE~INJECTABLE;INTRAMUSCULAR~RISPERDAL CONSTA~JANSSEN PHARMS~50MG/VIAL~N
~021346~003~~Oct 29, 2003~No~RX~JANSSEN PHARMACEUTICALS INC
TRIPTORELIN PAMOATE~INJECTABLE;INTRAMUSCULAR~TRELSTAR~ACTAVIS LABS UT INC~EQ 3.7
5MG BASE/VIAL~N~020715~001~~Jun 15, 2000~Yes~RX~ACTAVIS LABORATORIES UT INC
TRIPTORELIN PAMOATE~INJECTABLE;INTRAMUSCULAR~TRELSTAR~ACTAVIS LABS UT INC~EQ 11.
25MG BASE/VIAL~N~021288~001~~Jun 29, 2001~Yes~RX~ACTAVIS LABORATORIES UT INC
TRIPTORELIN PAMOATE~INJECTABLE;INTRAMUSCULAR~TRELSTAR~ACTAVIS LABS UT INC~EQ 22.
5MG BASE/VIAL~N~022437~001~~Mar 10, 2010~Yes~RX~ACTAVIS LABORATORIES UT INC
OLANZAPINE~INJECTABLE;INTRAMUSCULAR~ZYPREXA~LILLY~10MG/VIAL~N~021253~001~AP~Mar
EPINEPHRINE HYDROCHLORIDE~INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS~AD
RENALIN~PAR STERILE PRODUCTS~EQ 1MG BASE/ML (EQ 1MG BASE/ML)~N~204200~001~~Dec 7
, 2012~Yes~RX~PAR STERILE PRODUCTS LLC
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~AKORN INC~E
Q 1GM BASE/VIAL~A~065305~003~AP~Jan 11, 2008~No~RX~AKORN INC
Q 2GM BASE/VIAL~A~065305~004~AP~Jan 11, 2008~No~RX~AKORN INC
Q 250MG BASE/VIAL~A~065305~001~AP~Jan 11, 2008~No~RX~AKORN INC
Q 500MG BASE/VIAL~A~065305~002~AP~Jan 11, 2008~No~RX~AKORN INC
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~AUROBINDO P
HARMA LTD~EQ 1GM BASE/VIAL~A~065505~003~~Jul 31, 2008~No~DISCN~AUROBINDO PHARMA
LTD
HARMA LTD~EQ 2GM BASE/VIAL~A~065505~004~~Jul 31, 2008~No~DISCN~AUROBINDO PHARMA
LTD
HARMA LTD~EQ 250MG BASE/VIAL~A~065505~001~~Jul 31, 2008~No~DISCN~AUROBINDO PHARM
A LTD
HARMA LTD~EQ 500MG BASE/VIAL~A~065505~002~~Jul 31, 2008~No~DISCN~AUROBINDO PHARM
A LTD
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~BEDFORD~EQ
1GM BASE/VIAL~A~065465~003~AP~Aug 18, 2008~No~RX~BEDFORD LABORATORIES DIV BEN VE
NUE LABORATORIES INC
2GM BASE/VIAL~A~065465~004~AP~Aug 18, 2008~No~RX~BEDFORD LABORATORIES DIV BEN VE
NUE LABORATORIES INC
250MG BASE/VIAL~A~065465~001~AP~Aug 18, 2008~No~RX~BEDFORD LABORATORIES DIV BEN
500MG BASE/VIAL~A~065465~002~AP~Aug 18, 2008~No~RX~BEDFORD LABORATORIES DIV BEN
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~CEPHAZONE P

HARMA~EQ 1GM BASE/VIAL~A~065294~003~~Mar 26, 2007~No~DISCN~CEPHAZONE PHARMA LLC
HARMA~EQ 2GM BASE/VIAL~A~065294~004~~Mar 26, 2007~No~DISCN~CEPHAZONE PHARMA LLC
HARMA~EQ 250MG BASE/VIAL~A~065294~001~~Mar 26, 2007~No~DISCN~CEPHAZONE PHARMA LL
C
HARMA~EQ 500MG BASE/VIAL~A~065294~002~~Mar 26, 2007~No~DISCN~CEPHAZONE PHARMA LL
C
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~FACTA FARMA
~EQ 1GM BASE/VIAL~A~065268~001~~Feb 28, 2007~No~DISCN~FACTA FARMACEUTICI SPA
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~FACTA FARMA
~EQ 2GM BASE/VIAL~A~065268~002~~Feb 28, 2007~No~DISCN~FACTA FARMACEUTICI SPA
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~FRESENIUS K
ABI USA~EQ 1GM BASE/VIAL~A~065245~003~~Feb 15, 2006~No~DISCN~FRESENIUS KABI USA
LLC
ABI USA~EQ 2GM BASE/VIAL~A~065245~004~~Feb 15, 2006~No~DISCN~FRESENIUS KABI USA
LLC
ABI USA~EQ 250MG BASE/VIAL~A~065245~001~AP~Feb 15, 2006~No~RX~FRESENIUS KABI USA
LLC
ABI USA~EQ 500MG BASE/VIAL~A~065245~002~~Feb 15, 2006~No~DISCN~FRESENIUS KABI US
A LLC
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~HIKMA FARMA
CEUTICA~EQ 1GM BASE/VIAL~A~065342~003~AP~Jan 10, 2008~No~RX~HIKMA FARMACEUTICA (
PORTUGAL) SA
CEUTICA~EQ 2GM BASE/VIAL~A~065342~004~AP~Jan 10, 2008~No~RX~HIKMA FARMACEUTICA (
PORTUGAL) SA
CEUTICA~EQ 250MG BASE/VIAL~A~065342~001~AP~Jan 10, 2008~No~RX~HIKMA FARMACEUTICA
(PORTUGAL) SA
CEUTICA~EQ 500MG BASE/VIAL~A~065342~002~AP~Jan 10, 2008~No~RX~HIKMA FARMACEUTICA
(PORTUGAL) SA
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~HOSPIRA INC
~EQ 1GM BASE/VIAL~A~065230~003~AP~Aug 2, 2005~No~RX~HOSPIRA INC
~EQ 2GM BASE/VIAL~A~065230~004~AP~Aug 2, 2005~No~RX~HOSPIRA INC
~EQ 250MG BASE/VIAL~A~065230~001~AP~Aug 2, 2005~No~RX~HOSPIRA INC
~EQ 500MG BASE/VIAL~A~065230~002~AP~Aug 2, 2005~No~RX~HOSPIRA INC
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~LUPIN~EQ 1G
M BASE/VIAL~A~065125~003~AP~Sep 30, 2003~No~RX~LUPIN LTD
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~LUPIN~EQ 2G
M BASE/VIAL~A~065125~004~AP~Sep 30, 2003~No~RX~LUPIN LTD
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~LUPIN~EQ 25
0MG BASE/VIAL~A~065125~001~AP~Sep 30, 2003~No~RX~LUPIN LTD
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~LUPIN~EQ 50
0MG BASE/VIAL~A~065125~002~AP~Sep 30, 2003~No~RX~LUPIN LTD
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~SANDOZ~EQ 1
GM BASE/VIAL~A~065169~003~AP~May 9, 2005~Yes~RX~SANDOZ INC
GM BASE/VIAL~A~065169~004~AP~May 9, 2005~Yes~RX~SANDOZ INC
50MG BASE/VIAL~A~065169~001~AP~May 9, 2005~Yes~RX~SANDOZ INC

00MG BASE/VIAL~A~065169~002~AP~May 9, 2005~Yes~RX~SANDOZ INC
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~TEVA~EQ 1GM
BASE/VIAL~A~065262~001~~Jun 29, 2006~No~DISCN~TEVA PHARMACEUTICALS USA INC
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~TEVA~EQ 2GM
BASE/VIAL~A~065262~002~~Jun 29, 2006~No~DISCN~TEVA PHARMACEUTICALS USA INC
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~TEVA PHARMS
USA~EQ 1GM BASE/VIAL~A~065227~003~~Mar 15, 2007~No~DISCN~TEVA PHARMACEUTICALS U
SA
USA~EQ 2GM BASE/VIAL~A~065227~004~~Mar 15, 2007~No~DISCN~TEVA PHARMACEUTICALS U
SA
USA~EQ 250MG BASE/VIAL~A~065227~001~~Mar 15, 2007~No~DISCN~TEVA PHARMACEUTICALS
USA
USA~EQ 500MG BASE/VIAL~A~065227~002~~Mar 15, 2007~No~DISCN~TEVA PHARMACEUTICALS
USA
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFTRIAXONE~WOCKHARDT~E
Q 2GM BASE/VIAL~A~065391~003~AP~Apr 12, 2007~No~RX~WOCKHARDT LTD
Q 250MG BASE/VIAL~A~065391~001~AP~Apr 12, 2007~No~RX~WOCKHARDT LTD
Q 500MG BASE/VIAL~A~065391~002~AP~Apr 12, 2007~No~RX~WOCKHARDT LTD
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFUROXIME SODIUM~FACTA
FARMA~EQ 750MG BASE/VIAL~A~064125~001~AB~May 30, 1997~No~RX~FACTA FARMACEUTICI S
PA
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFUROXIME SODIUM~FRESEN
IUS KABI USA~EQ 750MG BASE/VIAL~A~065001~001~~May 30, 2001~No~DISCN~FRESENIUS KA
BI USA LLC
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFUROXIME SODIUM~HIKMA
FARMACEUTICA~EQ 750MG BASE/VIAL~A~065048~001~AB~Jan 9, 2004~No~RX~HIKMA FARMACEU
TICA PORTUGAL LDA
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFUROXIME SODIUM~HOSPIR
A INC~EQ 750MG BASE/VIAL~A~065483~001~AP~Oct 15, 2008~No~RX~HOSPIRA INC
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFUROXIME SODIUM~TEVA P
HARMS~EQ 1.5GM BASE/VIAL~A~064192~001~~Apr 16, 1998~No~DISCN~TEVA PHARMACEUTICAL
S USA
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFUROXIME SODIUM~TEVA P
HARMS~EQ 750MG BASE/VIAL~A~064192~002~~Apr 16, 1998~No~DISCN~TEVA PHARMACEUTICAL
S USA
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~CEFUROXIME SODIUM~WATSON
LABS INC~EQ 750MG BASE/VIAL~A~064035~001~~Feb 26, 1993~No~DISCN~WATSON LABORATO
RIES INC
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~KEFUROX~ACS DOBFAR~EQ 75
0MG BASE/VIAL~A~062591~001~~Jan 10, 1986~No~DISCN~ACS DOBFAR SPA
PENICILLIN G SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~PENICILLIN G SODIUM~SA
NDOZ~5,000,000 UNITS/VIAL~A~065068~001~~Feb 26, 2001~Yes~RX~SANDOZ INC
PENICILLIN G SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~PENICILLIN G SODIUM~WA
TSON LABS INC~5,000,000 UNITS/VIAL~A~063014~001~~Sep 13, 1988~No~DISCN~WATSON LA
BORATORIES INC
CEFTRIAXONE SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~ROCEPHIN~HOFFMANN LA RO
CHE~EQ 1GM BASE/VIAL~N~050585~003~~Dec 21, 1984~No~DISCN~HOFFMANN LA ROCHE INC
CHE~EQ 2GM BASE/VIAL~N~050585~004~~Dec 21, 1984~No~DISCN~HOFFMANN LA ROCHE INC
CHE~EQ 250MG BASE/VIAL~N~050585~001~~Dec 21, 1984~No~DISCN~HOFFMANN LA ROCHE INC
CHE~EQ 500MG BASE/VIAL~N~050585~002~~Dec 21, 1984~No~DISCN~HOFFMANN LA ROCHE INC
CEFUROXIME SODIUM~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS~ZINACEF~COVIS INJECTABLE
S~EQ 750MG BASE/VIAL~N~050558~002~AB~Oct 19, 1983~Yes~RX~COVIS INJECTABLES SARL

ATROPINE SULFATE~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS~ATROPINE SU
LFATE ANSYR PLASTIC SYRINGE~HOSPIRA~0.05MG/ML~N~021146~002~~Jul 9, 2001~Yes~RX~H
OSPIRA INC
ATROPINE SULFATE~INJECTABLE;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS~ATROPINE SU
LFATE ANSYR PLASTIC SYRINGE~HOSPIRA~0.1MG/ML~N~021146~001~~Jul 9, 2001~Yes~RX~HO
SPIRA INC
ERTAPENEM SODIUM~INJECTABLE;INTRAMUSCULAR, IV (INFUSION)~INVANZ~MERCK SHARP DOHM
E~EQ 1GM BASE/VIAL~N~021337~001~~Nov 21, 2001~Yes~RX~MERCK SHARP AND DOHME CORP
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~ADRENACLICK~AMEDRA PHARMS~EQ
0.15MG/DELIVERY~N~020800~003~BX~Nov 25, 2009~Yes~RX~AMEDRA PHARMACEUTICALS LLC
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~ADRENACLICK~AMEDRA PHARMS~EQ
0.3MG/DELIVERY~N~020800~004~BX~Nov 25, 2009~Yes~RX~AMEDRA PHARMACEUTICALS LLC
EPINEPHRINE HYDROCHLORIDE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~ADRENALIN~PAR S
TERILE PRODUCTS~EQ 30MG BASE/30ML (EQ 1MG BASE/ML)~N~204640~001~~Dec 18, 2013~Ye
s~RX~PAR STERILE PRODUCTS LLC
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~AUVI-Q~SANOFI AVENTIS US~EQ 0
.15MG/DELIVERY~N~201739~002~BX~Aug 10, 2012~Yes~RX~SANOFI AVENTIS US LLC
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~AUVI-Q~SANOFI AVENTIS US~EQ 0
.3MG/DELIVERY~N~201739~001~BX~Aug 10, 2012~No~RX~SANOFI AVENTIS US LLC
UROFOLLITROPIN~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~BRAVELLE~FERRING~75 IU/VIA
L~N~021289~001~~May 6, 2002~Yes~RX~FERRING PHARMACEUTICALS INC
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~EPIPEN~MYLAN SPECLT~0.3MG/DEL
IVERY~N~019430~001~BX~Dec 22, 1987~Yes~RX~MYLAN SPECIALTY LP
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~EPIPEN JR.~MYLAN SPECLT~0.15M
G/DELIVERY~N~019430~002~BX~Dec 22, 1987~Yes~RX~MYLAN SPECIALTY LP
FOLLITROPIN ALFA/BETA~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~FOLLISTIM~ORGANON U
SA INC~75 IU/VIAL~N~020582~001~~Sep 29, 1997~No~DISCN~ORGANON USA INC
FOLLITROPIN ALFA/BETA~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~FOLLISTIM~ORGANON U
SA INC~150 IU/VIAL~N~020582~002~~Sep 29, 1997~No~DISCN~ORGANON USA INC
MENOTROPINS (FSH;LH)~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~REPRONEX~FERRING~75
IU/VIAL;75 IU/VIAL~N~021047~001~~Aug 27, 1999~Yes~RX~FERRING PHARMACEUTICALS INC
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~TWINJECT 0.15~AMEDRA PHARMS~E
Q 0.15MG/DELIVERY~N~020800~002~BX~May 28, 2004~Yes~RX~AMEDRA PHARMACEUTICALS LLC
EPINEPHRINE~INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS~TWINJECT 0.3~AMEDRA PHARMS~EQ
0.3MG/DELIVERY~N~020800~001~BX~May 30, 2003~Yes~RX~AMEDRA PHARMACEUTICALS LLC
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARB
ONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE~INJECTABLE;INTRA
THECAL~ELLIOTTS B SOLUTION~LUKARE MEDICAL LLC~0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/M
L;1.9MG/ML;7.3MG/ML;0.2MG/ML~N~020577~001~~Sep 27, 1996~Yes~RX~LUKARE MEDICAL LL
C
BACLOFEN~INJECTABLE;INTRATHECAL~GABLOFEN~MALLINCKRODT INC~0.05MG/ML~N~022462~001
~AP~Nov 19, 2010~No~RX~MALLINCKRODT INC
BACLOFEN~INJECTABLE;INTRATHECAL~GABLOFEN~MALLINCKRODT INC~0.5MG/ML~N~022462~002~
AP~Nov 19, 2010~No~RX~MALLINCKRODT INC
BACLOFEN~INJECTABLE;INTRATHECAL~GABLOFEN~MALLINCKRODT INC~1MG/ML~N~022462~004~~J
un 22, 2012~No~RX~MALLINCKRODT INC
BACLOFEN~INJECTABLE;INTRATHECAL~GABLOFEN~MALLINCKRODT INC~2MG/ML~N~022462~003~AP
~Nov 19, 2010~No~RX~MALLINCKRODT INC
GENTAMICIN SULFATE~INJECTABLE;INTRATHECAL~GARAMYCIN~SCHERING~EQ 2MG BASE/ML~N~05
0505~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOU
GH CORP
BACLOFEN~INJECTABLE;INTRATHECAL~LIORESAL~MEDTRONIC NEURO~0.05MG/ML~N~020075~003~
AP~Nov 7, 1996~Yes~RX~MEDTRONIC NEUROMODULATION
BACLOFEN~INJECTABLE;INTRATHECAL~LIORESAL~MEDTRONIC NEURO~0.5MG/ML~N~020075~001~A
P~Jun 17, 1992~Yes~RX~MEDTRONIC NEUROMODULATION
BACLOFEN~INJECTABLE;INTRATHECAL~LIORESAL~MEDTRONIC NEURO~2MG/ML~N~020075~002~AP~
Jun 17, 1992~Yes~RX~MEDTRONIC NEUROMODULATION
INDIUM IN-111 PENTETATE DISODIUM~INJECTABLE;INTRATHECAL~MPI INDIUM DTPA IN 111~G
E HEALTHCARE~1mCi/ML~N~017707~001~~Feb 18, 1982~Yes~RX~GE HEALTHCARE
IOTROLAN~INJECTABLE;INTRATHECAL~OSMOVIST 190~BAYER HLTHCARE~40.6%~N~019580~001~~

Dec 7, 1989~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
IOTROLAN~INJECTABLE;INTRATHECAL~OSMOVIST 240~BAYER HLTHCARE~51.3%~N~019580~002~~
Dec 7, 1989~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
ZICONOTIDE ACETATE~INJECTABLE;INTRATHECAL~PRIALT~JAZZ PHARMS INTL~100MCG/1ML (10
0MCG/ML)~N~021060~002~~Dec 28, 2004~Yes~RX~JAZZ PHARMACEUTICALS INTERNATIONAL LT
D
0MCG/ML)~N~021060~003~~Dec 28, 2004~No~DISCN~JAZZ PHARMACEUTICALS INTERNATIONAL
LTD
D
D
ACETYLCYSTEINE~INJECTABLE;INTRAVENOUS~ACETADOTE~CUMBERLAND PHARMS~6GM/30ML (200M
G/ML)~N~021539~001~AP~Jan 23, 2004~Yes~RX~CUMBERLAND PHARMACEUTICALS INC
ACETYLCYSTEINE~INJECTABLE;INTRAVENOUS~ACETYLCYSTEINE~INNOPHARMA LICENSING~6GM/30
ML (200MG/ML)~A~200644~001~AP~Nov 7, 2012~No~RX~INNOPHARMA LICENSING LLC
FLUORESCEIN SODIUM~INJECTABLE;INTRAVENOUS~AK-FLUOR 10%~AKORN~EQ 500MG BASE/5ML (
EQ 100MG BASE/ML)~N~022186~001~AP~Aug 8, 2008~No~RX~AKORN INC
FLUORESCEIN SODIUM~INJECTABLE;INTRAVENOUS~AK-FLUOR 25%~AKORN~EQ 500MG BASE/2ML (
EQ 250MG BASE/ML)~N~022186~002~~Aug 8, 2008~Yes~RX~AKORN INC
PALONOSETRON HYDROCHLORIDE~INJECTABLE;INTRAVENOUS~ALOXI~HELSINN HLTHCARE~EQ 0.07
5MG BASE/1.5ML (EQ 0.05MG BASE/ML)~N~021372~002~~Feb 29, 2008~Yes~RX~HELSINN HEA
LTHCARE SA
PALONOSETRON HYDROCHLORIDE~INJECTABLE;INTRAVENOUS~ALOXI~HELSINN HLTHCARE~EQ 0.25
MG BASE/5ML (EQ 0.05MG BASE/ML)~N~021372~001~~Jul 25, 2003~Yes~RX~HELSINN HEALTH
CARE SA
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~BRIGHAM WOMENS HOSP~30mCi-300mC
i/8ML (3.75-37.5mCi/ML)~A~203783~001~AP~Oct 30, 2014~No~RX~BRIGHAM AND WOMENS HO
SP INC
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~CARDINAL HEALTH 414~30mCi-300mC
i/8ML (3.75-37.5mCi/ML)~A~203700~001~AP~Feb 25, 2013~No~RX~CARDINAL HEALTH 414 L
LC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~FEINSTEIN~30mCi-300mCi/8ML (3.7
5-37.5mCi/ML)~N~022119~001~AP~Aug 23, 2007~Yes~RX~FEINSTEIN INSTITUTE MEDICAL RE
SEARCH
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~GLOBAL ISOTOPES LLC~30mCi-300mC
i/8ML (3.75-37.5mCi/ML)~A~204465~001~AP~Oct 23, 2014~No~RX~GLOBAL ISOTOPES LLC D
BA ZEVACOR MOLECULAR
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~HOUSTON CYCLOTRON~3.75-260mCi/M
L~A~203543~001~~Dec 14, 2012~No~RX~HOUSTON CYCLOTRON PARTNERS LP
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~JOHNS HOPKINS UNIV~30mCi-300mCi
/8ML (3.75-37.5mCi/ML)~A~204514~001~AP~Aug 19, 2014~No~RX~JOHNS HOPKINS UNIV
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~KREITCHMAN PET CTR~30mCi-300mCi
/8ML (3.75-37.5mCi/ML)~A~203938~001~AP~Dec 9, 2013~No~RX~KREITCHMAN PET CENTER
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~MCPRF~30mCi-300mCi/8ML (3.75-37
.5mCi/ML)~A~203321~001~AP~Feb 25, 2013~No~RX~MAYO CLINIC PET RADIOCHEMISTRY FACI
LITY
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~MIPS CRF~30mCi-300mCi/8ML (3.75
-37.5mCi/ML)~A~204535~001~AP~Nov 20, 2014~No~RX~MIPS CYCLOTRON AND RADIOCHEMISTR
Y FACILITY
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~NCM USA BRONX LLC~3.75-260mCi/m
L~A~204515~001~~Feb 4, 2015~No~RX~NCM USA BRONX LLC
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~SHERTECH LABS LLC~3.75-260mCi/M
L~A~204366~001~~Sep 19, 2014~No~RX~SHERTECH LABORATORIES LLC
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~UCLA BIOMEDICAL~30mCi-300mCi/8M
L (3.75-37.5mCi/ML)~A~203812~001~AP~Jun 27, 2013~No~RX~UCLA BIOMEDICAL CYCLOTRON
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~UCSF RODIOPHARM~30mCi-300mCi/8M

L (3.75-37.5mCi/ML)~A~204496~001~AP~Mar 28, 2014~No~RX~UCSF RADIOPHARMACEUTICAL
FACILITY
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~UNIV TX MD ANDERSON~30mCi-300mC
i/8ML (3.75-37.5mCi/ML)~A~203933~001~AP~Jun 27, 2014~No~RX~UNIV TEXAS MD ANDERSO
N CANCER CENTER
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~WA UNIV SCH MED~30mCi-300mCi/8M
L (3.75-37.5mCi/ML)~A~204506~001~AP~Feb 7, 2014~No~RX~WASHINGTON UNIV SCHOOL MED
ICINE
AMMONIA N-13~INJECTABLE;INTRAVENOUS~AMMONIA N 13~WI MEDCL CYCLOTRON~3.75-260mCi/
ML~A~204356~001~~Dec 18, 2014~No~RX~WISCONSIN MEDICAL CYCLOTRON LLC
BIVALIRUDIN~INJECTABLE;INTRAVENOUS~ANGIOMAX~MEDICINES CO~250MG/VIAL~N~020873~001
~~Dec 15, 2000~Yes~RX~THE MEDICINES CO
IBANDRONATE SODIUM~INJECTABLE;INTRAVENOUS~BONIVA~ROCHE~EQ 3MG BASE/3ML~N~021858~
001~AP~Jan 6, 2006~Yes~RX~HOFFMANN LA ROCHE INC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INTRAVENOUS~CARDENE IN 0.83% SODIUM CHLORID
E IN PLASTIC CONTAINER~CHIESI USA INC~40MG/200ML (0.2MG/ML)~N~019734~004~~Nov 7,
2008~Yes~RX~CHIESI USA INC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INTRAVENOUS~CARDENE IN 0.86% SODIUM CHLORID
E IN PLASTIC CONTAINER~CHIESI USA INC~20MG/200ML (0.1MG/ML)~N~019734~003~~Jul 31
, 2008~Yes~RX~CHIESI USA INC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INTRAVENOUS~CARDENE IN 4.8% DEXTROSE IN PLA
STIC CONTAINER~CHIESI USA INC~20MG/200ML (0.1MG/ML)~N~019734~002~~Jul 31, 2008~Y
es~RX~CHIESI USA INC
NICARDIPINE HYDROCHLORIDE~INJECTABLE;INTRAVENOUS~CARDENE IN 5.0% DEXTROSE IN PLA
STIC CONTAINER~CHIESI USA INC~40MG/200ML (0.2MG/ML)~N~019734~005~~Nov 7, 2008~Ye
s~RX~CHIESI USA INC
CHOLINE C-11~INJECTABLE;INTRAVENOUS~CHOLINE C-11~MCPRF~4-33.1mCi/ML~N~203155~001
~~Sep 12, 2012~Yes~RX~MAYO CLINIC PET RADIOCHEMISTRY FACILITY
DECITABINE~INJECTABLE;INTRAVENOUS~DACOGEN~OTSUKA PHARM CO LTD~50MG/VIAL~N~021790
~001~AP~May 2, 2006~Yes~RX~OTSUKA PHARMACEUTICAL CO LTD
DECITABINE~INJECTABLE;INTRAVENOUS~DECITABINE~DR REDDYS LABS LTD~50MG/VIAL~A~2031
31~001~AP~Jul 11, 2013~No~RX~DR REDDYS LABORATORIES LTD
DECITABINE~INJECTABLE;INTRAVENOUS~DECITABINE~SANDOZ~50MG/VIAL~A~202969~001~AP~Au
g 28, 2014~No~RX~SANDOZ INC
PERFLUTREN~INJECTABLE;INTRAVENOUS~DEFINITY~LANTHEUS MEDCL~6.52MG/ML~N~021064~001
~~Jul 31, 2001~Yes~RX~LANTHEUS MEDICAL IMAGING INC
ESOMEPRAZOLE SODIUM~INJECTABLE;INTRAVENOUS~ESOMEPRAZOLE SODIUM~SUN PHARMA GLOBAL
~EQ 20MG BASE/VIAL~A~200882~001~AP~Mar 18, 2013~No~RX~SUN PHARMA GLOBAL FZE
ESOMEPRAZOLE SODIUM~INJECTABLE;INTRAVENOUS~ESOMEPRAZOLE SODIUM~SUN PHARMA GLOBAL
~EQ 40MG BASE/VIAL~A~200882~002~AP~Mar 18, 2013~No~RX~SUN PHARMA GLOBAL FZE
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F 18~UNIV NORTH DAKO
TA~4-500mCi/ML~A~203994~001~~Feb 4, 2015~No~RX~UNIV NORTH DAKOTA
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~BRIGHAM WOMENS~2
0-300mCi/ML~A~203816~001~AP~Oct 30, 2014~No~RX~BRIGHAM AND WOMENS HOSP
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~CHILDRENS HOSP M
I~20-300mCi/ML~A~204385~001~AP~Oct 29, 2014~No~RX~CHILDRENS HOSP MICHIGAN
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~CPDC~20-300mCi/M
L~A~204525~001~AP~Oct 29, 2014~No~RX~CENTRE FOR PROBE DEVELOPMENT AND COMMERCIAL
IZATION
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~ESSENTIAL ISOTOP
ES~20-300mCi/ML~A~203946~001~AP~Feb 5, 2014~No~RX~ESSENTIAL ISOTOPES LLC
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~FEINSTEIN~20-200
mCi/ML~N~021870~001~AP~Aug 19, 2005~Yes~RX~FEINSTEIN INSTITUTE MEDICAL RESEARCH
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~FEINSTEIN~20-400
mCi/ML~N~021870~002~AP~Nov 21, 2008~Yes~RX~FEINSTEIN INSTITUTE MEDICAL RESEARCH
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~GLOBAL ISOTOPES
LLC~20-300mCi/ML~A~204463~001~AP~Oct 21, 2014~No~RX~GLOBAL ISOTOPES LLC DBA ZEVA
COR MOLECULAR
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~HOT SHOTS NM LLC
~4-500mCi/ML~A~203937~001~~Oct 30, 2014~No~RX~HOT SHOTS NUCLEAR MEDICINE LLC

FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~HOUSTON CYCLOTRO
N~20-500mCi/ML~A~203665~001~AP~Feb 14, 2013~Yes~RX~HOUSTON CYCLOTRON PARTNERS LP
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~LANTHEUS MEDICAL
~20-200mCi/ML~A~203664~001~AP~Feb 4, 2014~No~RX~LANTHEUS MEDICAL IMAGING INC
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~MA GENERAL HOSP~
20-300mCi/ML~A~204333~001~AP~Sep 25, 2014~No~RX~MASSACHUSETTS GENERAL HOSP
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~MCPRF~20-240mCi/
ML~A~203612~001~AP~Aug 5, 2013~No~RX~MAYO CLINIC PET RADIOCHEMISTRY FACILITY
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~NCM USA BRONX LL
C~20-300mCi/ML~A~204512~001~AP~Jan 7, 2015~No~RX~NCM USA BRONX LLC
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~PETNET~20-200mCi
/ML~A~079086~001~AP~Feb 25, 2011~No~RX~PETNET SOLUTIONS INC
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~SHERTECH LABS LL
C~20-300mCi/ML~A~204264~001~AP~Dec 18, 2014~No~RX~SHERTECH LABORATORIES LLC
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~TRUSTEES UNIV PA
~20-200mCi/ML~A~203801~001~AP~Oct 29, 2014~No~RX~TRUSTEES OF THE UNIV OF PENNSYL
VANIA
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~UCLA BIOMEDICAL~
4-40mCi/ML~A~203811~001~~Jun 27, 2013~Yes~RX~UCLA BIOMEDICAL CYCLOTRON
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~UCSF RODIOPHARM~
20-300mCi/ML~A~203902~001~AP~May 9, 2014~No~RX~UCSF RADIOPHARMACEUTICAL FACILITY
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~UIHC PET IMAGING
~20-300mCi/ML~A~203990~001~AP~Aug 6, 2014~No~RX~UNIV IOWA HOSPS AND CLINICS PET
IMAGING CENTER
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~UNIV TX MD ANDER
SON~20-150mCi/ML~A~203246~001~~Jan 13, 2014~No~RX~UNIV TEXAS MD ANDERSON CANCER
CENTER
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~UNIV TX MD ANDER
SON~20-300mCi/ML~A~203246~002~AP~Jan 13, 2014~No~RX~UNIV TEXAS MD ANDERSON CANCE
R CENTER
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~WEILL MEDCL COLL
~10-100mCi/ML **Federal Register determination that product was not discontinued
or withdrawn for safety or efficacy reasons**~N~021768~001~~Aug 5, 2004~No~DISC
N~WEILL MEDICAL COLLEGE CORNELL UNIV
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~WI MEDCL CYCLOTR
ON~20-500mCi/ML~A~203709~001~AP~Oct 23, 2013~No~RX~WISCONSIN MEDICAL CYCLOTRON L
LC
FLUDEOXYGLUCOSE F-18~INJECTABLE;INTRAVENOUS~FLUDEOXYGLUCOSE F18~WUSM CYCLOTRON~2
0-300mCi/ML~A~203935~001~AP~Feb 5, 2014~No~RX~WASHINGTON UNIV SCH MEDICINE CYCLO
TRON FACILITY
FLUORESCEIN SODIUM~INJECTABLE;INTRAVENOUS~FLUORESCITE~ALCON PHARMS LTD~EQ 500MG
BASE/5ML (EQ 100MG BASE/ML)~N~021980~001~AP~Mar 28, 2006~Yes~RX~ALCON PHARMACEUT
ICALS LTD
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~FLUORINE F-18~GE HEALTHCARE~2mCi/ML
for safety or efficacy reasons**~N~017042~001~~Approved Prior to Jan 1, 1982~No~
DISCN~GE HEALTHCARE
IBANDRONATE SODIUM~INJECTABLE;INTRAVENOUS~IBANDRONATE SODIUM~AGILA SPECLTS~EQ 3M
G BASE/3ML~A~202671~001~AP~Sep 2, 2014~No~RX~AGILA SPECIALTIES PRIVATE LTD
IBANDRONATE SODIUM~INJECTABLE;INTRAVENOUS~IBANDRONATE SODIUM~EMCURE PHARMS LTD~E
Q 3MG BASE/3ML~A~203987~001~AP~Sep 2, 2014~No~RX~EMCURE PHARMACEUTICALS LTD
IBANDRONATE SODIUM~INJECTABLE;INTRAVENOUS~IBANDRONATE SODIUM~SAGENT PHARMS~EQ 3M
G BASE/3ML~A~202235~001~AP~Sep 2, 2014~No~RX~SAGENT PHARMACEUTICALS INC
IBANDRONATE SODIUM~INJECTABLE;INTRAVENOUS~IBANDRONATE SODIUM~SUN PHARM INDS LTD~
EQ 3MG BASE/3ML~A~090853~001~AP~Feb 14, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES
LTD
IFOSFAMIDE; MESNA~INJECTABLE;INTRAVENOUS~IFOSFAMIDE/MESNA KIT~TEVA PHARMS USA~1G
M/20ML;1GM/10ML (50MG/ML;100MG/ML)~A~075874~001~~Feb 26, 2002~Yes~RX~TEVA PHARMA
CEUTICALS USA
IFOSFAMIDE; MESNA~INJECTABLE;INTRAVENOUS~IFOSFAMIDE/MESNA KIT~TEVA PHARMS USA~3G

M/60ML;1GM/10ML (50MG/ML;100MG/ML)~A~075874~002~~Feb 26, 2002~Yes~RX~TEVA PHARMA
CEUTICALS USA
DIMYRISTOYL LECITHIN; PERFLEXANE~INJECTABLE;INTRAVENOUS~IMAGENT~IMCOR PHARMS CO~
0.92MG/VIAL;0.092MG/VIAL~N~021191~001~~May 31, 2002~No~DISCN~IMCOR PHARMACEUTICA
LS CO
FERRIC CARBOXYMALTOSE~INJECTABLE;INTRAVENOUS~INJECTAFER~LUITPOLD~750MG IRON/15ML
(50MG IRON/ML)~N~203565~001~~Jul 25, 2013~Yes~RX~LUITPOLD PHARMACEUTICALS INC
CEFUROXIME SODIUM~INJECTABLE;INTRAVENOUS~KEFUROX~LILLY~EQ 750MG BASE/VIAL~A~0625
92~001~~Jan 10, 1986~No~DISCN~ELI LILLY AND CO
CEFUROXIME SODIUM~INJECTABLE;INTRAVENOUS~KEFUROX IN PLASTIC CONTAINER~LILLY~EQ 7
50MG BASE/VIAL~A~062590~001~~Jan 10, 1986~No~DISCN~ELI LILLY AND CO
MESNA~INJECTABLE;INTRAVENOUS~MESNA~AGILA SPECLTS~100MG/ML~A~203364~001~AP~Jul 18
MESNA~INJECTABLE;INTRAVENOUS~MESNA~EUROHLTH INTL SARL~100MG/ML~A~075739~001~AP~J
an 9, 2004~No~RX~EUROHEALTH INTERNATIONAL SARL
MESNA~INJECTABLE;INTRAVENOUS~MESNA~FRESENIUS KABI USA~100MG/ML~A~075811~001~AP~A
pr 26, 2001~No~RX~FRESENIUS KABI USA LLC
MESNA~INJECTABLE;INTRAVENOUS~MESNA~MYLAN INSTITUTIONAL~100MG/ML~A~076488~001~AP~
Mar 8, 2012~No~RX~MYLAN INSTITUTIONAL LLC
MESNA~INJECTABLE;INTRAVENOUS~MESNA~SAGENT PHARMS~100MG/ML~A~090913~001~AP~Apr 13
, 2010~No~RX~SAGENT PHARMACEUTICALS INC
MESNA~INJECTABLE;INTRAVENOUS~MESNA~TEVA PHARMS USA~100MG/ML~A~075764~001~AP~Apr
MESNA~INJECTABLE;INTRAVENOUS~MESNEX~BAXTER HLTHCARE~100MG/ML~N~019884~001~AP~Dec
30, 1988~Yes~RX~BAXTER HEALTHCARE CORP
GADOBENATE DIMEGLUMINE~INJECTABLE;INTRAVENOUS~MULTIHANCE~BRACCO~2.645GM/5ML (529
MG/ML)~N~021357~001~~Nov 23, 2004~Yes~RX~BRACCO DIAGNOSTICS INC
MG/ML)~N~021357~002~~Nov 23, 2004~Yes~RX~BRACCO DIAGNOSTICS INC
9MG/ML)~N~021357~003~~Nov 23, 2004~Yes~RX~BRACCO DIAGNOSTICS INC
9MG/ML)~N~021357~004~~Nov 23, 2004~Yes~RX~BRACCO DIAGNOSTICS INC
GADOBENATE DIMEGLUMINE~INJECTABLE;INTRAVENOUS~MULTIHANCE MULTIPACK~BRACCO~26.45G
M/50ML (529MG/ML)~N~021358~001~~Nov 23, 2004~Yes~RX~BRACCO DIAGNOSTICS INC
GADOBENATE DIMEGLUMINE~INJECTABLE;INTRAVENOUS~MULTIHANCE MULTIPACK~BRACCO~52.9GM
/100ML (529MG/ML)~N~021358~002~~Nov 23, 2004~Yes~RX~BRACCO DIAGNOSTICS INC
IBUPROFEN LYSINE~INJECTABLE;INTRAVENOUS~NEOPROFEN~RECORDATI RARE~EQ 20MG BASE/2M
L (EQ 10MG BASE/ML)~N~021903~001~~Apr 13, 2006~Yes~RX~RECORDATI RARE DISEASES IN
C
ESOMEPRAZOLE SODIUM~INJECTABLE;INTRAVENOUS~NEXIUM IV~ASTRAZENECA PHARMS~EQ 20MG
BASE/VIAL~N~021689~001~AP~Mar 31, 2005~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
ESOMEPRAZOLE SODIUM~INJECTABLE;INTRAVENOUS~NEXIUM IV~ASTRAZENECA PHARMS~EQ 40MG
BASE/VIAL~N~021689~002~AP~Mar 31, 2005~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
LANSOPRAZOLE~INJECTABLE;INTRAVENOUS~PREVACID IV~TAKEDA PHARMS NA~30MG/VIAL~N~021
566~001~~May 27, 2004~No~DISCN~TAKEDA PHARMACEUTICALS NORTH AMERICA INC
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F 18~NIH NCI DCTD~10
-200mCi/ML~N~022494~001~~Jan 26, 2011~No~DISCN~NATIONAL INSTITUTES HEALTH NATION
AL CANCER INSTITUTE DIV CANCER TREATMENT AND DIAGNOSIS
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~BIOMEDCL RES FD
N~10-200mCi/ML~A~204351~001~AP~Jan 9, 2015~No~RX~BIOMEDICAL RESEARCH FOUNDATION
NORTHWEST LOUISANA
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~ESSENTIAL ISOTO
PES~10-200mCi/ML~A~204541~001~AP~Oct 29, 2014~No~RX~ESSENTIAL ISOTOPES LLC
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~GLOBAL ISOTOPES
LLC~10-200mCi/ML~A~204464~001~AP~Oct 21, 2014~No~RX~GLOBAL ISOTOPES LLC DBA ZEV
ACOR MOLECULAR
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~HOUSTON CYCLOTR
ON~10-200mCi/ML~A~203544~001~AP~Dec 26, 2012~Yes~RX~HOUSTON CYCLOTRON PARTNERS L
P
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~MCPRF~10-91.5mC
i/ML~A~203605~001~~Jun 28, 2013~Yes~RX~MAYO CLINIC PET RADIOCHEMISTRY FACILITY
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~NCM USA BRONX L
LC~10-200mCi/ML~A~204513~001~AP~Nov 28, 2014~No~RX~NCM USA BRONX LLC
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~PRECISION NUCLE
AR~10-200mCi/ML~A~204542~001~AP~Feb 27, 2015~No~RX~PRECISION NUCLEAR LLC
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~SHERTECH LABS L
LC~10-200mCi/ML~A~204315~001~AP~Sep 22, 2014~No~RX~SHERTECH LABORATORIES LLC
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~THE FEINSTEIN I
NST~20-600mCi/ML~A~204328~001~~Nov 19, 2014~No~RX~THE FEINSTEIN INSTITUTE FOR ME
DICAL RESEARCH
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~UCSF RODIOPHARM
~10-200mCi/ML~A~204437~001~AP~Mar 13, 2014~No~RX~UCSF RADIOPHARMACEUTICAL FACILI
TY
SODIUM FLUORIDE F-18~INJECTABLE;INTRAVENOUS~SODIUM FLUORIDE F-18~UNIV TX MD ANDE
RSON~10-200mCi/ML~A~203247~001~AP~Dec 23, 2013~No~RX~UNIV TEXAS MD ANDERSON CANC
ER CENTER
THALLOUS CHLORIDE TL-201~INJECTABLE;INTRAVENOUS~THALLOUS CHLORIDE TL 201~LANTHEU
S MEDCL~2mCi/ML~N~017806~002~AP~Oct 9, 1998~Yes~RX~LANTHEUS MEDICAL IMAGING INC
THALLOUS CHLORIDE TL-201~INJECTABLE;INTRAVENOUS~THALLOUS CHLORIDE TL 201~MALLINC
KRODT~2mCi/ML~A~077698~001~~Nov 9, 2006~No~DISCN~MALLINCKRODT INC
IRON SUCROSE~INJECTABLE;INTRAVENOUS~VENOFER~LUITPOLD~EQ 50MG BASE/2.5ML (EQ 20MG
BASE/ML)~N~021135~002~~Mar 20, 2005~No~RX~LUITPOLD PHARMACEUTICALS INC
IRON SUCROSE~INJECTABLE;INTRAVENOUS~VENOFER~LUITPOLD~EQ 65MG BASE/3.25ML (EQ 20M
G BASE/ML)~N~021135~005~~Mar 29, 2013~No~DISCN~LUITPOLD PHARMACEUTICALS INC
IRON SUCROSE~INJECTABLE;INTRAVENOUS~VENOFER~LUITPOLD~EQ 75MG BASE/3.75ML (EQ 20M
G BASE/ML)~N~021135~003~~Mar 29, 2005~No~DISCN~LUITPOLD PHARMACEUTICALS INC
IRON SUCROSE~INJECTABLE;INTRAVENOUS~VENOFER~LUITPOLD~EQ 100MG BASE/5ML (EQ 20MG
BASE/ML)~N~021135~001~~Nov 6, 2000~Yes~RX~LUITPOLD PHARMACEUTICALS INC
IRON SUCROSE~INJECTABLE;INTRAVENOUS~VENOFER~LUITPOLD~EQ 200MG BASE/10ML (EQ 20MG
BASE/ML)~N~021135~004~~Feb 9, 2007~No~RX~LUITPOLD PHARMACEUTICALS INC
FLUTEMETAMOL F-18~INJECTABLE;INTRAVENOUS~VIZAMYL~GE HEALTHCARE~40.5mCi/10ML (4.0
5mCi/ML)~N~203137~001~~Oct 25, 2013~Yes~RX~GE HEALTHCARE
FLUTEMETAMOL F-18~INJECTABLE;INTRAVENOUS~VIZAMYL~GE HEALTHCARE~121.5mCi/30ML (4.
05mCi/ML)~N~203137~002~~Oct 25, 2013~Yes~RX~GE HEALTHCARE
AZACITIDINE~INJECTABLE;INTRAVENOUS, SUBCUTANEOUS~AZACITIDINE~DR REDDYS LABS LTD~
100MG/VIAL~A~201537~001~AP~Sep 16, 2013~No~RX~DR REDDYS LABORATORIES LTD
ENOXAPARIN SODIUM~INJECTABLE;INTRAVENOUS, SUBCUTANEOUS~ENOXAPARIN SODIUM~SANDOZ
INC~300MG/3ML (100MG/ML)~A~078660~001~AB~Nov 28, 2011~No~RX~SANDOZ INC
ENOXAPARIN SODIUM~INJECTABLE;INTRAVENOUS, SUBCUTANEOUS~LOVENOX~SANOFI AVENTIS US
~300MG/3ML (100MG/ML)~N~020164~009~AB~Jan 23, 2003~No~RX~SANOFI AVENTIS US LLC
BORTEZOMIB~INJECTABLE;INTRAVENOUS, SUBCUTANEOUS~VELCADE~MILLENNIUM PHARMS~3.5MG/
VIAL~N~021602~001~~May 13, 2003~Yes~RX~MILLENNIUM PHARMACEUTICALS INC
AZACITIDINE~INJECTABLE;INTRAVENOUS, SUBCUTANEOUS~VIDAZA~CELGENE~100MG/VIAL~N~050
794~001~AP~May 19, 2004~Yes~RX~CELGENE CORP
PEGAPTANIB SODIUM~INJECTABLE;INTRAVITREAL~MACUGEN~VALEANT PHARMS LLC~EQ 0.3MG AC
ID/0.09ML~N~021756~001~~Dec 17, 2004~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERIC
A LLC
TRIAMCINOLONE ACETONIDE~INJECTABLE;INTRAVITREAL~TRIESENCE~ALCON~40MG/ML (40MG/ML
)~N~022048~001~~Nov 29, 2007~Yes~RX~ALCON INC
PEMETREXED DISODIUM~INJECTABLE;IV (INFUSION)~ALIMTA~LILLY~EQ 100MG BASE/VIAL~N~0
21462~002~~Sep 7, 2007~Yes~RX~ELI LILLY AND CO
PEMETREXED DISODIUM~INJECTABLE;IV (INFUSION)~ALIMTA~LILLY~EQ 500MG BASE/VIAL~N~0
21462~001~~Feb 4, 2004~Yes~RX~ELI LILLY AND CO
ARGATROBAN~INJECTABLE;IV (INFUSION)~ARGATROBAN IN 0.9% SODIUM CHLORIDE~TEVA PHAR
MS USA~250MG/250ML (1MG/ML)~N~206769~001~~Dec 15, 2014~No~RX~TEVA PHARMACEUTICAL
S USA
ARGATROBAN~INJECTABLE;IV (INFUSION)~ARGATROBAN IN SODIUM CHLORIDE~EAGLE PHARMS~5
0MG/50ML (1MG/ML)~N~022434~001~~Jun 29, 2011~Yes~RX~EAGLE PHARMACEUTICALS INC
ARGATROBAN~INJECTABLE;IV (INFUSION)~ARGATROBAN IN SODIUM CHLORIDE~SANDOZ~125MG/1

25ML (1MG/ML)~N~022485~001~~May 9, 2011~Yes~RX~SANDOZ INC
NELARABINE~INJECTABLE;IV (INFUSION)~ARRANON~SMITHKLINE BEECHAM~250MG/50ML (5MG/M
L)~N~021877~001~~Oct 28, 2005~Yes~RX~SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
MOXIFLOXACIN HYDROCHLORIDE~INJECTABLE;IV (INFUSION)~AVELOX IN SODIUM CHLORIDE 0.
8% IN PLASTIC CONTAINER~BAYER HLTHCARE~160MG/100ML~N~021277~001~~Nov 30, 2001~Ye
CASPOFUNGIN ACETATE~INJECTABLE;IV (INFUSION)~CANCIDAS~MERCK~50MG/VIAL~N~021227~0
01~~Jan 26, 2001~Yes~RX~MERCK AND CO INC
CASPOFUNGIN ACETATE~INJECTABLE;IV (INFUSION)~CANCIDAS~MERCK~70MG/VIAL~N~021227~0
02~~Jan 26, 2001~Yes~RX~MERCK AND CO INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~ACTAVIS TOTOWA~50MG/5ML (10MG/M
L)~A~078732~001~AP~Feb 6, 2012~No~RX~ACTAVIS TOTOWA LLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~ACTAVIS TOTOWA~150MG/15ML (10MG
/ML)~A~078732~002~AP~Feb 6, 2012~No~RX~ACTAVIS TOTOWA LLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~AKORN~50MG/5ML (10MG/ML)~A~0904
75~001~AP~Jul 29, 2009~No~RX~AKORN INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~CIPLA LTD~50MG/5ML (10MG/ML)~A~
077861~001~AP~Jan 18, 2007~No~RX~CIPLA LTD
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~CIPLA LTD~150MG/15ML (10MG/ML)~
A~077861~002~AP~Jan 18, 2007~No~RX~CIPLA LTD
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~EBEWE PHARMA~50MG/5ML (10MG/ML)
~A~078280~001~AP~May 8, 2008~No~RX~EBEWE PHARMA GES MBH NFG KG
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~EBEWE PHARMA~150MG/15ML (10MG/M
L)~A~078280~002~AP~May 8, 2008~No~RX~EBEWE PHARMA GES MBH NFG KG
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~EBEWE PHARMA~450MG/45ML (10MG/M
L)~A~078280~003~AP~May 8, 2008~No~RX~EBEWE PHARMA GES MBH NFG KG
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~EUROHLTH INTL SARL~50MG/5ML (10
MG/ML)~A~077244~001~AP~Oct 15, 2004~No~RX~EUROHEALTH INTERNATIONAL SARL
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~EUROHLTH INTL SARL~150MG/15ML (
10MG/ML)~A~077244~002~AP~Oct 15, 2004~No~RX~EUROHEALTH INTERNATIONAL SARL
10MG/ML)~A~077244~003~AP~Oct 15, 2004~No~RX~EUROHEALTH INTERNATIONAL SARL
10MG/ML)~A~077244~004~AP~Jan 20, 2006~No~RX~EUROHEALTH INTERNATIONAL SARL
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~FRESENIUS KABI ONCOL~50MG/5ML (
10MG/ML)~A~077432~001~AP~Sep 29, 2006~No~RX~FRESENIUS KABI ONCOLOGY PLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~FRESENIUS KABI ONCOL~150MG/15ML
(10MG/ML)~A~077432~002~AP~Sep 29, 2006~No~RX~FRESENIUS KABI ONCOLOGY PLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~FRESENIUS KABI ONCOL~450MG/45ML
(10MG/ML)~A~077432~003~AP~Sep 29, 2006~No~RX~FRESENIUS KABI ONCOLOGY PLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~FRESENIUS KABI USA~50MG/5ML (10
MG/ML)~A~077247~001~~Oct 21, 2004~No~DISCN~FRESENIUS KABI USA LLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~FRESENIUS KABI USA~50MG/5ML (10
MG/ML)~A~077266~001~~Feb 15, 2006~No~DISCN~FRESENIUS KABI USA LLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~FRESENIUS KABI USA~150MG/15ML (
10MG/ML)~A~077247~002~~Oct 21, 2004~No~DISCN~FRESENIUS KABI USA LLC

10MG/ML)~A~077266~002~~Feb 15, 2006~No~DISCN~FRESENIUS KABI USA LLC
10MG/ML)~A~077247~003~AP~Oct 21, 2004~No~RX~FRESENIUS KABI USA LLC
10MG/ML)~A~077266~003~AP~Feb 15, 2006~No~RX~FRESENIUS KABI USA LLC
10MG/ML)~A~077266~004~AP~Feb 15, 2006~No~RX~FRESENIUS KABI USA LLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~HOSPIRA~50MG/5ML (10MG/ML)~A~07
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~HOSPIRA~150MG/15ML (10MG/ML)~A~
077059~001~AP~Nov 23, 2004~No~RX~HOSPIRA INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~MYLAN INSTITUTIONAL~50MG/5ML (1
0MG/ML)~A~077998~001~AP~Apr 24, 2007~No~RX~MYLAN INSTITUTIONAL LLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~MYLAN INSTITUTIONAL~150MG/15ML
(10MG/ML)~A~077998~002~AP~Apr 24, 2007~No~RX~MYLAN INSTITUTIONAL LLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~MYLAN INSTITUTIONAL~450MG/45ML
(10MG/ML)~A~077998~003~AP~Apr 24, 2007~No~RX~MYLAN INSTITUTIONAL LLC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~ONCO THERAPIES LTD~1GM/100ML (1
0MG/ML)~A~091478~001~~Nov 23, 2011~Yes~RX~ONCO THERAPIES LTD
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~ONCO THERAPIES LTD~50MG/5ML (10
MG/ML)~A~091063~001~AP~Nov 9, 2011~No~RX~ONCO THERAPIES LTD
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~ONCO THERAPIES LTD~150MG/15ML (
10MG/ML)~A~091063~002~AP~Nov 9, 2011~No~RX~ONCO THERAPIES LTD
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~PHARMACHEMIE BV~50MG/5ML (10MG/
ML)~A~077269~001~AP~Oct 14, 2004~Yes~RX~PHARMACHEMIE BV
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~PHARMACHEMIE BV~50MG/5ML (10MG/
ML)~A~077679~001~~Feb 25, 2009~No~DISCN~PHARMACHEMIE BV
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~PHARMACHEMIE BV~150MG/15ML (10M
G/ML)~A~077269~002~AP~Oct 14, 2004~Yes~RX~PHARMACHEMIE BV
G/ML)~A~077679~002~~Feb 25, 2009~No~DISCN~PHARMACHEMIE BV
G/ML)~A~077269~003~AP~Oct 14, 2004~Yes~RX~PHARMACHEMIE BV
G/ML)~A~077679~003~~Feb 25, 2009~No~DISCN~PHARMACHEMIE BV
G/ML)~A~077269~004~AP~Dec 28, 2007~Yes~RX~PHARMACHEMIE BV
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~PLIVA LACHEMA~50MG/5ML (10MG/ML
)~A~078631~001~AP~Dec 2, 2008~No~RX~PLIVA LACHEMA AS
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~PLIVA LACHEMA~150MG/15ML (10MG/
ML)~A~078631~002~AP~Dec 2, 2008~No~RX~PLIVA LACHEMA AS
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~SAGENT PHARMS~50MG/5ML (10MG/ML
)~A~077096~001~AP~Jun 14, 2005~No~RX~SAGENT PHARMACEUTICALS INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~SAGENT PHARMS~150MG/15ML (10MG/
ML)~A~077096~002~AP~Jun 14, 2005~No~RX~SAGENT PHARMACEUTICALS INC

CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~SUN PHARMA GLOBAL~50MG/5ML (10M
G/ML)~A~077926~001~AP~Sep 19, 2008~No~RX~SUN PHARMA GLOBAL INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~SUN PHARMA GLOBAL~150MG/15ML (1
0MG/ML)~A~077926~002~AP~Sep 19, 2008~No~RX~SUN PHARMA GLOBAL INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~SUN PHARMA GLOBAL~450MG/45ML (1
0MG/ML)~A~077926~003~AP~Sep 19, 2008~No~RX~SUN PHARMA GLOBAL INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~TEVA PARENTERAL~50MG/5ML (10MG/
ML)~A~077389~001~~Mar 30, 2007~No~DISCN~TEVA PARENTERAL MEDICINES INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~TEVA PARENTERAL~150MG/15ML (10M
G/ML)~A~077389~002~~Mar 30, 2007~No~DISCN~TEVA PARENTERAL MEDICINES INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~TEVA PARENTERAL~450MG/45ML (10M
G/ML)~A~077389~003~~Mar 30, 2007~No~DISCN~TEVA PARENTERAL MEDICINES INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~TEVA PHARMS USA~50MG/5ML (10MG/
ML)~A~077139~001~AP~Sep 21, 2005~Yes~RX~TEVA PHARMACEUTICALS USA
CARBOPLATIN~INJECTABLE;IV (INFUSION)~CARBOPLATIN~TEVA PHARMS USA~150MG/15ML (10M
G/ML)~A~077139~002~AP~Sep 21, 2005~Yes~RX~TEVA PHARMACEUTICALS USA
CLOFARABINE~INJECTABLE;IV (INFUSION)~CLOLAR~GENZYME~20MG/20ML (1MG/ML)~N~021673~
001~~Dec 28, 2004~Yes~RX~GENZYME CORP
DAPTOMYCIN~INJECTABLE;IV (INFUSION)~CUBICIN~CUBIST~250MG/VIAL~N~021572~001~~Sep
12, 2003~No~DISCN~CUBIST PHARMACEUTICALS INC
DAPTOMYCIN~INJECTABLE;IV (INFUSION)~CUBICIN~CUBIST~500MG/VIAL~N~021572~002~AP~Se
p 12, 2003~Yes~RX~CUBIST PHARMACEUTICALS INC
DALBAVANCIN HYDROCHLORIDE~INJECTABLE;IV (INFUSION)~DALVANCE~DURATA THERAPS INTL~
EQ 500MG BASE/VIAL~N~021883~001~~May 23, 2014~Yes~RX~DURATA THERAPEUTICS INTERNA
TIONAL BV
DAPTOMYCIN~INJECTABLE;IV (INFUSION)~DAPTOMYCIN~HOSPIRA INC~500MG/VIAL~A~202857~0
DORIPENEM~INJECTABLE;IV (INFUSION)~DORIBAX~SHIONOGI INC~250MG/VIAL~N~022106~002~
~Oct 5, 2010~No~RX~SHIONOGI INC
DORIPENEM~INJECTABLE;IV (INFUSION)~DORIBAX~SHIONOGI INC~500MG/VIAL~N~022106~001~
~Oct 12, 2007~Yes~RX~SHIONOGI INC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~ELOXATIN~SANOFI AVENTIS US~50MG/VIAL~N~0214
92~001~~Aug 9, 2002~No~DISCN~SANOFI AVENTIS US LLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~ELOXATIN~SANOFI AVENTIS US~50MG/10ML (5MG/M
L)~N~021759~001~AP~Jan 31, 2005~Yes~RX~SANOFI AVENTIS US LLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~ELOXATIN~SANOFI AVENTIS US~100MG/VIAL~N~021
OXALIPLATIN~INJECTABLE;IV (INFUSION)~ELOXATIN~SANOFI AVENTIS US~100MG/20ML (5MG/
ML)~N~021759~002~AP~Jan 31, 2005~Yes~RX~SANOFI AVENTIS US LLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~ELOXATIN~SANOFI AVENTIS US~200MG/40ML (5MG/
ML)~N~021759~003~~Nov 17, 2006~Yes~RX~SANOFI AVENTIS US LLC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;IV (INFUSION)~EPIRUBICIN HYDROCHLORIDE~HOSPI
RA~50MG/VIAL~N~050807~001~~Sep 15, 2006~No~DISCN~HOSPIRA INC
EPIRUBICIN HYDROCHLORIDE~INJECTABLE;IV (INFUSION)~EPIRUBICIN HYDROCHLORIDE~HOSPI
RA~200MG/VIAL~N~050807~002~~Sep 15, 2006~No~DISCN~HOSPIRA INC
ANIDULAFUNGIN~INJECTABLE;IV (INFUSION)~ERAXIS~VICURON~50MG/VIAL~N~021632~001~~Fe
b 17, 2006~Yes~RX~VICURON PHARMACEUTICALS INC
ANIDULAFUNGIN~INJECTABLE;IV (INFUSION)~ERAXIS~VICURON~100MG/VIAL~N~021632~002~~N
ov 14, 2006~Yes~RX~VICURON PHARMACEUTICALS INC
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~INJECT
ABLE;IV (INFUSION)~INFUVITE ADULT~SANDOZ~2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/
ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML~N~0215
59~001~~Jun 16, 2003~Yes~RX~SANDOZ CANADA INC
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/VI
AL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1
.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL~N~021265~001~~Feb 21, 2001~Yes~RX~S
ANDOZ CANADA INC
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID
; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A;
VITAMIN K~INJECTABLE;IV (INFUSION)~INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)~SA
NDOZ~80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VI
AL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL~N~021646~00
1~~Jan 29, 2004~Yes~RX~SANDOZ CANADA INC
IXABEPILONE~INJECTABLE;IV (INFUSION)~IXEMPRA KIT~BRISTOL MYERS SQUIBB~15MG/VIAL~
N~022065~001~~Oct 16, 2007~Yes~RX~BRISTOL MYERS SQUIBB CO
IXABEPILONE~INJECTABLE;IV (INFUSION)~IXEMPRA KIT~BRISTOL MYERS SQUIBB~45MG/VIAL~
N~022065~002~~Oct 16, 2007~Yes~RX~BRISTOL MYERS SQUIBB CO
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~KEPPRA~UCB INC~500MG/5ML (100MG/ML)~N~021
872~001~AP~Jul 31, 2006~Yes~RX~UCB INC
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~LEVETIRACETAM~FRESENIUS KABI USA~500MG/5M
L (100MG/ML)~A~090813~001~AP~May 26, 2010~No~RX~FRESENIUS KABI USA LLC
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~LEVETIRACETAM~HIKMA FARMACEUTICA~500MG/5M
L(100MG/ML)~A~090981~001~AP~Oct 13, 2011~No~RX~HIKMA FARMACEUTICA (PORTUGAL) SA
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~LEVETIRACETAM~HOSPIRA INC~500MG/ML (100MG
/ML)~A~202869~001~AP~Apr 6, 2012~No~RX~HOSPIRA INC
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~LEVETIRACETAM~LUITPOLD~500MG/5ML (100MG/M
L)~A~202143~001~AP~Jan 31, 2012~No~RX~LUITPOLD PHARMACEUTICALS INC
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~LEVETIRACETAM~SAGENT PHARMS~500MG/5ML (10
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~LEVETIRACETAM~SUN PHARM INDS LTD~500MG/5M
L (100MG/ML)~A~090754~001~AP~Jun 16, 2010~No~RX~SUN PHARMACEUTICAL INDUSTRIES LT
D
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~LEVETIRACETAM~X GEN PHARMS~500MG/5ML (100
MG/ML)~A~091485~001~AP~Aug 5, 2011~No~RX~X GEN PHARMACEUTICALS INC
LEVETIRACETAM~INJECTABLE;IV (INFUSION)~LEVETIRACETAM IN SODIUM CHLORIDE~HQ SPECI
ALITY PHARMA~500MG/100ML (5MG/ML)~N~202543~001~~Nov 9, 2011~Yes~RX~HQ SPECIALITY
PHARMA LLC
ALITY PHARMA~1000MG/100ML (10MG/ML)~N~202543~002~~Nov 9, 2011~Yes~RX~HQ SPECIALI
TY PHARMA LLC
ALITY PHARMA~1500MG/100ML (15MG/ML)~N~202543~003~~Nov 9, 2011~Yes~RX~HQ SPECIALI
TY PHARMA LLC
HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K~INJECTABLE;IV (INFUSION)~M.V.I.
ADULT~HOSPIRA~200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/V
IAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL~N~0216
25~001~~Jan 30, 2004~Yes~RX~HOSPIRA INC
HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K~INJECTABLE;IV (INFUSION)~M.V.I.
ADULT (PHARMACY BULK PACKAGE)~HOSPIRA~200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5ML;
0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0.15MG
/5ML~N~021643~001~~Feb 18, 2004~Yes~RX~HOSPIRA INC
MICAFUNGIN SODIUM~INJECTABLE;IV (INFUSION)~MYCAMINE~ASTELLAS~50MG/VIAL~N~021506~
002~~Mar 16, 2005~Yes~RX~ASTELLAS PHARMA US INC
MICAFUNGIN SODIUM~INJECTABLE;IV (INFUSION)~MYCAMINE~ASTELLAS~100MG/VIAL~N~021506
~003~~Jun 27, 2006~Yes~RX~ASTELLAS PHARMA US INC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~ACTAVIS TOTOWA~50MG/VIAL~A~0788

03~001~AP~Aug 8, 2012~No~RX~ACTAVIS TOTOWA LLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~ACTAVIS TOTOWA~100MG/VIAL~A~078
803~002~AP~Aug 8, 2012~No~RX~ACTAVIS TOTOWA LLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~EBEWE PHARMA~50MG/10ML (5MG/ML)
~A~078812~001~AP~Aug 7, 2009~No~RX~EBEWE PHARMA GES MBH NFG KG
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~EBEWE PHARMA~100MG/20ML (5MG/ML
)~A~078812~002~AP~Aug 7, 2009~No~RX~EBEWE PHARMA GES MBH NFG KG
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~FRESENIUS KABI ONCOL~50MG/10ML
(5MG/ML)~A~078811~001~AP~Jun 10, 2010~No~RX~FRESENIUS KABI ONCOLOGY PLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~FRESENIUS KABI ONCOL~100MG/20ML
(5MG/ML)~A~078811~002~AP~Jun 10, 2010~No~RX~FRESENIUS KABI ONCOLOGY PLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~FRESENIUS KABI ONCOL~50MG/VIAL~
A~078810~001~AP~Aug 7, 2009~No~RX~FRESENIUS KABI ONCOLOGY PLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~FRESENIUS KABI ONCOL~100MG/VIAL
~A~078810~002~AP~Aug 7, 2009~No~RX~FRESENIUS KABI ONCOLOGY PLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~FRESENIUS KABI USA~50MG/VIAL~A~
078819~001~AP~Jun 2, 2010~No~RX~FRESENIUS KABI USA LLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~FRESENIUS KABI USA~100MG/VIAL~A
~078819~002~AP~Jun 2, 2010~No~RX~FRESENIUS KABI USA LLC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~HOSPIRA INC~50MG/VIAL~A~078815~
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~HOSPIRA INC~100MG/VIAL~A~078815
~002~AP~Sep 30, 2009~No~RX~HOSPIRA INC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~HOSPIRA WORLDWIDE~50MG/10ML (5M
G/ML)~A~078813~001~AP~Aug 7, 2009~No~RX~HOSPIRA WORLDWIDE PTY
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~HOSPIRA WORLDWIDE~100MG/20ML (5
MG/ML)~A~078813~002~AP~Aug 7, 2009~No~RX~HOSPIRA WORLDWIDE PTY
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~JIANGSU HENGRUI MED~50MG/10ML (
5MG/ML)~A~203869~001~AP~Jun 18, 2014~No~RX~JIANGSU HENGRUI MEDICINE CO LTD
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~JIANGSU HENGRUI MED~100MG/20ML
(5MG/ML)~A~203869~002~AP~Jun 18, 2014~No~RX~JIANGSU HENGRUI MEDICINE CO LTD
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~ONCO THERAPIES LTD~50MG/10ML (5
MG/ML)~A~091358~001~AP~Aug 7, 2012~No~RX~ONCO THERAPIES LTD
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~ONCO THERAPIES LTD~50MG/VIAL~A~
200979~001~AP~Aug 8, 2012~No~RX~ONCO THERAPIES LTD
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~ONCO THERAPIES LTD~100MG/20ML (
5MG/ML)~A~091358~002~AP~Aug 7, 2012~No~RX~ONCO THERAPIES LTD
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~ONCO THERAPIES LTD~100MG/VIAL~A
~200979~002~AP~Aug 8, 2012~No~RX~ONCO THERAPIES LTD
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~SANDOZ~50MG/10ML (5MG/ML)~A~078
817~001~AP~Jan 24, 2011~No~RX~SANDOZ INC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~SANDOZ~50MG/VIAL~A~090849~001~~
Apr 28, 2011~No~DISCN~SANDOZ INC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~SANDOZ~100MG/20ML (5MG/ML)~A~07
8817~002~AP~Jan 24, 2011~No~RX~SANDOZ INC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~SANDOZ~100MG/VIAL~A~090849~002~
~Apr 28, 2011~No~DISCN~SANDOZ INC
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~SUN PHARMA GLOBAL~50MG/VIAL~A~0
78818~001~AP~Aug 7, 2009~Yes~RX~SUN PHARMA GLOBAL FZE
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~SUN PHARMA GLOBAL~50MG/10ML (5M
G/ML)~A~202922~001~AP~Apr 8, 2014~No~RX~SUN PHARMA GLOBAL FZE
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~SUN PHARMA GLOBAL~100MG/VIAL~A~
078818~002~AP~Aug 7, 2009~Yes~RX~SUN PHARMA GLOBAL FZE
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~SUN PHARMA GLOBAL~100MG/20ML (5
MG/ML)~A~202922~002~AP~Apr 8, 2014~No~RX~SUN PHARMA GLOBAL FZE
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~TEVA PHARMS~50MG/10ML (5MG/ML)~
N~022160~001~AP~Aug 7, 2009~Yes~RX~TEVA PHARMACEUTICALS USA
OXALIPLATIN~INJECTABLE;IV (INFUSION)~OXALIPLATIN~TEVA PHARMS~100MG/20ML (5MG/ML)
~N~022160~002~AP~Aug 7, 2009~Yes~RX~TEVA PHARMACEUTICALS USA
PANTOPRAZOLE SODIUM~INJECTABLE;IV (INFUSION)~PANTOPRAZOLE SODIUM~AKORN INC~EQ 40

MG BASE/VIAL~A~079197~001~AP~Nov 8, 2012~No~RX~AKORN INC
CARBOPLATIN~INJECTABLE;IV (INFUSION)~PARAPLATIN~CORDENPHARMA~50MG/5ML (10MG/ML)~
N~020452~001~~Jul 14, 2003~No~DISCN~CORDENPHARMA
CARBOPLATIN~INJECTABLE;IV (INFUSION)~PARAPLATIN~CORDENPHARMA~150MG/15ML (10MG/ML
)~N~020452~002~~Jul 14, 2003~No~DISCN~CORDENPHARMA
)~N~020452~003~~Jul 14, 2003~No~DISCN~CORDENPHARMA
)~N~020452~004~~Jan 15, 2004~No~DISCN~CORDENPHARMA
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM~INJECTABLE;IV (INFUSION)~PIPERACILLIN AND
TAZOBACTAM~SANDOZ~EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL~A~203557~001~~Oct 29, 20
14~No~RX~SANDOZ INC
PANTOPRAZOLE SODIUM~INJECTABLE;IV (INFUSION)~PROTONIX IV~WYETH PHARMS INC~EQ 40M
G BASE/VIAL~N~020988~001~AP~Mar 22, 2001~Yes~RX~WYETH PHARMACEUTICALS INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~RECLAST~NOVARTIS~EQ 5MG BASE/100ML~N~02
1817~001~AP~Apr 16, 2007~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
DALFOPRISTIN; QUINUPRISTIN~INJECTABLE;IV (INFUSION)~SYNERCID~KING PHARMS~350MG/V
IAL;150MG/VIAL~N~050748~001~~Sep 21, 1999~Yes~RX~KING PHARMACEUTICALS INC
DALFOPRISTIN; QUINUPRISTIN~INJECTABLE;IV (INFUSION)~SYNERCID~KING PHARMS~420MG/V
IAL;180MG/VIAL~N~050748~002~~Aug 24, 2000~No~DISCN~KING PHARMACEUTICALS INC
TIGECYCLINE~INJECTABLE;IV (INFUSION)~TYGACIL~PF PRISM CV~50MG/VIAL~N~021821~001~
~Jun 15, 2005~Yes~RX~PF PRISM CV
CONIVAPTAN HYDROCHLORIDE~INJECTABLE;IV (INFUSION)~VAPRISOL~CUMBERLAND PHARMS~20M
G/4ML (5MG/ML)~N~021697~001~~Dec 29, 2005~No~DISCN~CUMBERLAND PHARMACEUTICALS IN
C
CONIVAPTAN HYDROCHLORIDE~INJECTABLE;IV (INFUSION)~VAPRISOL IN 5% DEXTROSE IN PLA
STIC CONTAINER~CUMBERLAND PHARMS~20MG/100ML (0.2MG/ML)~N~021697~002~~Oct 8, 2008
~Yes~RX~CUMBERLAND PHARMACEUTICALS INC
VORICONAZOLE~INJECTABLE;IV (INFUSION)~VFEND~PF PRISM CV~200MG/VIAL~N~021267~001~
AP~May 24, 2002~Yes~RX~PF PRISM CV
VORICONAZOLE~INJECTABLE;IV (INFUSION)~VORICONAZOLE~SANDOZ INC~200MG/VIAL~A~09086
VELAGLUCERASE ALFA~INJECTABLE;IV (INFUSION)~VPRIV~SHIRE HUMAN GENETIC~400 UNITS/
VIAL~N~022575~001~~Feb 26, 2010~No~RX~SHIRE HUMAN GENETIC THERAPIES INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~ACS DOBFAR INFO SA~EQ 4
MG BASE/100ML~N~203231~001~AP~Aug 2, 2013~No~RX~ACS DOBFAR INFO SA
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~ACS DOBFAR INFO SA~EQ 5
MG BASE/100ML~A~202828~001~AP~Sep 23, 2013~No~RX~ACS DOBFAR INFO SA
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~ACTAVIS INC~EQ 4MG BASE
/5ML~A~202472~001~AP~Mar 4, 2013~No~RX~ACTAVIS INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~AGILA SPECLTS~EQ 4MG BA
SE/5ML~A~202650~001~AP~Mar 4, 2013~No~RX~AGILA SPECIALTIES PRIVATE LTD
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~AKORN~EQ 5MG BASE/100ML
~A~200918~001~AP~Aug 21, 2014~No~RX~AKORN INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~AKORN INC~EQ 4MG BASE/5
ML~A~202548~001~AP~May 22, 2014~No~RX~AKORN INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~DR REDDYS LABS LTD~EQ 4
MG BASE/5ML~A~091186~001~AP~Mar 4, 2013~No~RX~DR REDDYS LABORATORIES LTD
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~DR REDDYS LABS LTD~EQ 5
MG BASE/100ML~A~091363~001~AP~Mar 29, 2013~No~RX~DR REDDYS LABORATORIES LTD
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~EMCURE PHARMS LTD~EQ 4M
G BASE/5ML~A~201783~001~AP~Mar 12, 2013~No~RX~EMCURE PHARMACEUTICALS LTD
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~EMCURE PHARMS LTD~EQ 5M
G BASE/100ML~A~201801~001~AP~Mar 29, 2013~No~RX~EMCURE PHARMACEUTICALS LTD
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~GLAND PHARMA LTD~EQ 4MG
BASE/5ML~A~202930~001~AP~Aug 5, 2013~No~RX~GLAND PHARMA LTD
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~HIKMA FARMACEUTICA~EQ 4
MG BASE/5ML~A~202182~001~AP~Jun 3, 2013~No~RX~HIKMA FARMACEUTICA SA
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~HOSPIRA INC~EQ 5MG BASE
/100ML~A~202837~001~AP~Apr 5, 2013~No~RX~HOSPIRA INC

ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~PHARMACEUTICS~EQ 4MG BA
SE/5ML~A~091170~001~AP~Mar 4, 2013~No~RX~PHARMACEUTICS INTERNATIONAL INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~PHARMACEUTICS~EQ 5MG BA
SE/100ML~A~202163~001~AP~Aug 5, 2013~No~RX~PHARMACEUTICS INTERNATIONAL INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~PHARMS~EQ 4MG BASE/5ML~
A~202571~001~AP~May 7, 2013~No~RX~PHARMACEUTICALS INTERNATIONAL
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~SAGENT PHARMS~EQ 4MG BA
SE/5ML~A~091493~001~AP~Nov 24, 2014~No~RX~SAGENT PHARMACEUTICALS INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~SUN PHARMA GLOBAL~EQ 4M
G BASE/VIAL~A~090018~001~AP~Mar 4, 2013~Yes~RX~SUN PHARMA GLOBAL FZE
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~SUN PHARMA GLOBAL~EQ 4M
G BASE/5ML~A~202746~001~AP~Mar 4, 2013~No~RX~SUN PHARMA GLOBAL FZE
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOLEDRONIC ACID~USV NORTH AMERICA~EQ 4M
G BASE/VIAL~A~202923~001~AP~Sep 4, 2014~No~RX~USV NORTH AMERICA INC
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOMETA~NOVARTIS~EQ 4MG BASE/VIAL **Fede
fety or efficacy reasons**~N~021223~001~~Aug 20, 2001~No~DISCN~NOVARTIS PHARMACE
UTICALS CORP
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOMETA~NOVARTIS~EQ 4MG BASE/5ML~N~02122
3~002~AP~Mar 7, 2003~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
ZOLEDRONIC ACID~INJECTABLE;IV (INFUSION)~ZOMETA~NOVARTIS~EQ 4MG BASE/100ML~N~021
INSULIN GLULISINE RECOMBINANT~INJECTABLE;IV (INFUSION), SUBCUTANEOUS~APIDRA~SANO
FI AVENTIS US~1000 UNITS/10ML (100 UNITS/ML)~N~021629~001~~Apr 16, 2004~Yes~RX~S
ANOFI AVENTIS US LLC
INSULIN GLULISINE RECOMBINANT~INJECTABLE;IV (INFUSION), SUBCUTANEOUS~APIDRA~SANO
FI AVENTIS US~300 UNITS/3ML (100 UNITS/ML)~N~021629~002~~Dec 20, 2005~Yes~RX~SAN
OFI AVENTIS US LLC
TREPROSTINIL~INJECTABLE;IV (INFUSION), SUBCUTANEOUS~REMODULIN~UNITED THERAP~1MG/
ML~N~021272~001~~May 21, 2002~No~RX~UNITED THERAPEUTICS CORP
TREPROSTINIL~INJECTABLE;IV (INFUSION), SUBCUTANEOUS~REMODULIN~UNITED THERAP~2.5M
G/ML~N~021272~002~~May 21, 2002~No~RX~UNITED THERAPEUTICS CORP
TREPROSTINIL~INJECTABLE;IV (INFUSION), SUBCUTANEOUS~REMODULIN~UNITED THERAP~5MG/
ML~N~021272~003~~May 21, 2002~No~RX~UNITED THERAPEUTICS CORP
TREPROSTINIL~INJECTABLE;IV (INFUSION), SUBCUTANEOUS~REMODULIN~UNITED THERAP~10MG
/ML~N~021272~004~~May 21, 2002~Yes~RX~UNITED THERAPEUTICS CORP
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;SPINAL~BUPIVACAINE HYDROCHLORIDE~HOSPIRA~0.
75%~A~071810~001~AP~Dec 11, 1987~No~RX~HOSPIRA INC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;SPINAL~LIDOCAINE HYDROCHLORIDE 5% AND DEXTROS
E 7.5%~HOSPIRA~5%~A~083914~001~~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIRA INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;SPINAL~MARCAINE~HOSPIRA~0.75%~N~018692~001~
AP~May 4, 1984~Yes~RX~HOSPIRA INC
BUPIVACAINE HYDROCHLORIDE~INJECTABLE;SPINAL~SENSORCAINE~FRESENIUS KABI USA~0.75%
~A~071202~001~AP~Apr 15, 1987~No~RX~FRESENIUS KABI USA LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;SPINAL~XYLOCAINE 1.5% W/ DEXTROSE 7.5%~FRESEN
IUS KABI USA~1.5%~N~016297~001~~Approved Prior to Jan 1, 1982~No~DISCN~FRESENIUS
KABI USA LLC
LIDOCAINE HYDROCHLORIDE~INJECTABLE;SPINAL~XYLOCAINE 5% W/ GLUCOSE 7.5%~ASTRAZENE
CA~5%~N~010496~002~~Jul 7, 1982~No~DISCN~ASTRAZENECA LP
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~ALSUMA~MERIDIAN MEDCL~EQ 6MG BASE/
0.5ML (EQ 12MG BASE/ML)~N~022377~001~BX~Jun 29, 2010~No~RX~MERIDIAN MEDICAL TECH
NOLOGIES INC SUB KING PHARMACEUTICALS INC
INSULIN GLULISINE RECOMBINANT~INJECTABLE;SUBCUTANEOUS~APIDRA SOLOSTAR~SANOFI AVE
NTIS US~300 UNITS/3ML~N~021629~003~~Feb 24, 2009~No~RX~SANOFI AVENTIS US LLC
APOMORPHINE HYDROCHLORIDE~INJECTABLE;SUBCUTANEOUS~APOKYN~US WORLDMEDS~20MG/2ML (
10MG/ML)~N~021264~001~~Apr 20, 2004~No~DISCN~US WORLDMEDS LLC
APOMORPHINE HYDROCHLORIDE~INJECTABLE;SUBCUTANEOUS~APOKYN~US WORLDMEDS~30MG/3ML (
10MG/ML)~N~021264~002~~Apr 20, 2004~Yes~RX~US WORLDMEDS LLC
FONDAPARINUX SODIUM~INJECTABLE;SUBCUTANEOUS~ARIXTRA~MYLAN IRELAND LTD~2.5MG/0.5M
L~N~021345~001~AP~Dec 7, 2001~Yes~RX~MYLAN IRELAND LTD

FONDAPARINUX SODIUM~INJECTABLE;SUBCUTANEOUS~ARIXTRA~MYLAN IRELAND LTD~5MG/0.4ML~
N~021345~002~AP~May 28, 2004~Yes~RX~MYLAN IRELAND LTD
FONDAPARINUX SODIUM~INJECTABLE;SUBCUTANEOUS~ARIXTRA~MYLAN IRELAND LTD~7.5MG/0.6M
L~N~021345~003~AP~May 28, 2004~Yes~RX~MYLAN IRELAND LTD
FONDAPARINUX SODIUM~INJECTABLE;SUBCUTANEOUS~ARIXTRA~MYLAN IRELAND LTD~10MG/0.8ML
~N~021345~004~AP~May 28, 2004~Yes~RX~MYLAN IRELAND LTD
EXENATIDE SYNTHETIC~INJECTABLE;SUBCUTANEOUS~BYETTA~ASTRAZENECA AB~300MCG/1.2ML (
250MCG/ML)~N~021773~001~~Apr 28, 2005~Yes~RX~ASTRAZENECA AB
EXENATIDE SYNTHETIC~INJECTABLE;SUBCUTANEOUS~BYETTA~ASTRAZENECA AB~600MCG/2.4ML (
250MCG/ML)~N~021773~002~~Apr 28, 2005~Yes~RX~ASTRAZENECA AB
GLATIRAMER ACETATE~INJECTABLE;SUBCUTANEOUS~COPAXONE~TEVA PHARMS USA~20MG/ML~N~02
0622~002~~Feb 12, 2002~Yes~RX~TEVA PHARMACEUTICALS USA
GLATIRAMER ACETATE~INJECTABLE;SUBCUTANEOUS~COPAXONE~TEVA PHARMS USA~40MG/ML~N~02
0622~003~~Jan 28, 2014~Yes~RX~TEVA PHARMACEUTICALS USA
MEDROXYPROGESTERONE ACETATE~INJECTABLE;SUBCUTANEOUS~DEPO-SUBQ PROVERA 104~PHARMA
CIA AND UPJOHN~104MG/0.65ML~N~021583~001~~Dec 17, 2004~Yes~RX~PHARMACIA AND UPJO
HN SUB PFIZER INC
LEUPROLIDE ACETATE~INJECTABLE;SUBCUTANEOUS~ELIGARD~TOLMAR THERAP~7.5MG/VIAL~N~02
1343~001~~Jan 23, 2002~Yes~RX~TOLMAR THERAPEUTICS INC
LEUPROLIDE ACETATE~INJECTABLE;SUBCUTANEOUS~ELIGARD~TOLMAR THERAP~22.5MG/VIAL~N~0
21379~001~~Jul 24, 2002~Yes~RX~TOLMAR THERAPEUTICS INC
LEUPROLIDE ACETATE~INJECTABLE;SUBCUTANEOUS~ELIGARD~TOLMAR THERAP~30MG/VIAL~N~021
488~001~~Feb 13, 2003~Yes~RX~TOLMAR THERAPEUTICS INC
LEUPROLIDE ACETATE~INJECTABLE;SUBCUTANEOUS~ELIGARD~TOLMAR THERAP~45MG/VIAL~N~021
731~001~~Dec 14, 2004~Yes~RX~TOLMAR THERAPEUTICS INC
ENOXAPARIN SODIUM~INJECTABLE;SUBCUTANEOUS~ENOXAPARIN SODIUM (PRESERVATIVE FREE)~
AMPHASTAR PHARM~30MG/0.3ML (100MG/ML)~A~076684~001~AP~Sep 19, 2011~No~RX~AMPHAST
AMPHASTAR PHARM~100MG/ML (100MG/ML)~A~076684~005~AP~Sep 19, 2011~No~RX~AMPHASTAR
PHARMACEUTICAL INC
AMPHASTAR PHARM~120MG/0.8ML (150MG/ML)~A~076684~006~AP~Sep 19, 2011~No~RX~AMPHAS
TAR PHARMACEUTICAL INC
AMPHASTAR PHARM~150MG/ML (150MG/ML)~A~076684~007~AP~Sep 19, 2011~No~RX~AMPHASTAR
PHARMACEUTICAL INC
SANDOZ~30MG/0.3ML (100MG/ML)~A~077857~002~AP~Jul 23, 2010~No~RX~SANDOZ INC
SANDOZ~100MG/ML (100MG/ML)~A~077857~001~AP~Jul 23, 2010~No~RX~SANDOZ INC
SANDOZ~150MG/ML (150MG/ML)~A~077857~007~AP~Jul 23, 2010~No~RX~SANDOZ INC

TEVA~30MG/0.3ML (100MG/ML)~A~076726~001~AP~Jun 23, 2014~No~RX~TEVA PHARMACEUTICA
LS USA INC
LS USA INC
LS USA INC
LS USA INC
TEVA~100MG/ML (100MG/ML)~A~076726~005~AP~Jun 23, 2014~No~RX~TEVA PHARMACEUTICALS
USA INC
TEVA~120MG/0.8ML (150MG/ML)~A~076726~006~AP~Jun 23, 2014~No~RX~TEVA PHARMACEUTIC
ALS USA INC
TEVA~150MG/ML (150MG/ML)~A~076726~007~AP~Jun 23, 2014~No~RX~TEVA PHARMACEUTICALS
USA INC
UROFOLLITROPIN~INJECTABLE;SUBCUTANEOUS~FERTINEX~SERONO~75 IU/AMP~N~019415~005~~A
ug 23, 1996~No~DISCN~SERONO LABORATORIES INC
UROFOLLITROPIN~INJECTABLE;SUBCUTANEOUS~FERTINEX~SERONO~150 IU/AMP~N~019415~004~~
Aug 23, 1996~No~DISCN~SERONO LABORATORIES INC
ICATIBANT ACETATE~INJECTABLE;SUBCUTANEOUS~FIRAZYR~SHIRE ORPHAN THERAP~EQ 30MG BA
SE/3ML (EQ 10MG BASE/ML)~N~022150~001~~Aug 25, 2011~Yes~RX~SHIRE ORPHAN THERAPIE
S INC
FOLLITROPIN ALFA/BETA~INJECTABLE;SUBCUTANEOUS~FOLLISTIM AQ~ORGANON USA INC~75 IU
/0.5ML~N~021273~001~~Aug 26, 2005~Yes~RX~ORGANON USA INC
FOLLITROPIN ALFA/BETA~INJECTABLE;SUBCUTANEOUS~FOLLISTIM AQ~ORGANON USA INC~150 I
U/0.18ML~N~021211~003~~Feb 11, 2004~No~DISCN~ORGANON USA INC
U/0.5ML~N~021273~002~~Aug 26, 2005~Yes~RX~ORGANON USA INC
U/0.36ML~N~021211~001~~Mar 23, 2004~Yes~RX~ORGANON USA INC
U/0.72ML~N~021211~002~~Mar 23, 2004~Yes~RX~ORGANON USA INC
U/1.08ML~N~021211~004~~Feb 11, 2005~Yes~RX~ORGANON USA INC
FONDAPARINUX SODIUM~INJECTABLE;SUBCUTANEOUS~FONDAPARINUX SODIUM~DR REDDYS LABS L
TD~2.5MG/0.5ML~A~091316~001~AP~Jul 11, 2011~No~RX~DR REDDYS LABORATORIES LTD
TD~5MG/0.4ML~A~091316~002~AP~Jul 11, 2011~No~RX~DR REDDYS LABORATORIES LTD
TD~7.5MG/0.6ML~A~091316~003~AP~Jul 11, 2011~No~RX~DR REDDYS LABORATORIES LTD
TD~10MG/0.8ML~A~091316~004~AP~Jul 11, 2011~No~RX~DR REDDYS LABORATORIES LTD
TERIPARATIDE RECOMBINANT HUMAN~INJECTABLE;SUBCUTANEOUS~FORTEO~LILLY~0.6MG/2.4ML
(0.25MG/ML)~N~021318~002~~Jun 25, 2008~Yes~RX~ELI LILLY AND CO
TERIPARATIDE RECOMBINANT HUMAN~INJECTABLE;SUBCUTANEOUS~FORTEO~LILLY~0.75MG/3ML (
0.25MG/ML)~N~021318~001~~Nov 26, 2002~No~DISCN~ELI LILLY AND CO
DALTEPARIN SODIUM~INJECTABLE;SUBCUTANEOUS~FRAGMIN~EISAI INC~2,500IU/0.2ML (12,50
0IU/ML)~N~020287~001~~Dec 22, 1994~No~RX~EISAI INC
0IU/ML)~N~020287~003~~Mar 18, 1996~No~RX~EISAI INC
0IU/ML)~N~020287~005~~Apr 4, 2002~No~RX~EISAI INC
00IU/ML)~N~020287~002~~May 1, 2007~No~DISCN~EISAI INC

DALTEPARIN SODIUM~INJECTABLE;SUBCUTANEOUS~FRAGMIN~EISAI INC~10,000IU/ML (10,000I
U/ML)~N~020287~004~~Jan 30, 1998~No~RX~EISAI INC
00IU/ML)~N~020287~009~~May 1, 2007~No~RX~EISAI INC
DALTEPARIN SODIUM~INJECTABLE;SUBCUTANEOUS~FRAGMIN~EISAI INC~18,000IU/0.72ML (25,
00IU/ML)~N~020287~006~~Apr 4, 2002~Yes~RX~EISAI INC
00IU/ML)~N~020287~007~~Apr 4, 2002~No~DISCN~EISAI INC
ENFUVIRTIDE~INJECTABLE;SUBCUTANEOUS~FUZEON~ROCHE~90MG/VIAL~N~021481~001~~Mar 13,
2003~Yes~RX~HOFFMANN LA ROCHE INC
FOLLITROPIN ALFA/BETA~INJECTABLE;SUBCUTANEOUS~GONAL-F~EMD SERONO~37.5 IU/VIAL~N~
020378~003~~May 25, 2000~No~DISCN~EMD SERONO INC
FOLLITROPIN ALFA/BETA~INJECTABLE;SUBCUTANEOUS~GONAL-F~EMD SERONO~37.5 IU/VIAL~N~
021765~001~~Mar 25, 2004~No~DISCN~EMD SERONO INC
FOLLITROPIN ALFA/BETA~INJECTABLE;SUBCUTANEOUS~GONAL-F~EMD SERONO~75 IU/VIAL~N~02
21765~003~~Mar 25, 2004~No~DISCN~EMD SERONO INC
20378~005~~Mar 26, 2004~Yes~RX~EMD SERONO INC
FOLLITROPIN ALFA/BETA~INJECTABLE;SUBCUTANEOUS~GONAL-F~EMD SERONO~1,050 IU/VIAL~N
~020378~004~~Feb 28, 2001~No~RX~EMD SERONO INC
FOLLITROPIN ALFA/BETA~INJECTABLE;SUBCUTANEOUS~GONAL-F RFF~EMD SERONO~75 IU/VIAL~
N~021765~002~~Mar 25, 2004~Yes~RX~EMD SERONO INC
FOLLITROPIN ALFA/BETA~INJECTABLE;SUBCUTANEOUS~GONAL-F RFF REDI-JECT~EMD SERONO~3
00 IU/0.5ML~N~021684~001~~May 25, 2004~Yes~RX~EMD SERONO INC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~IMITREX~GLAXOSMITHKLINE~EQ 6MG BAS
E/0.5ML (EQ 12MG BASE/ML)~N~020080~001~AP~Dec 28, 1992~Yes~RX~GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~IMITREX STATDOSE~GLAXOSMITHKLINE~E
Q 4MG BASE/0.5ML (EQ 8MG BASE/ML)~N~020080~002~BX~Feb 1, 2006~Yes~RX~GLAXOSMITHK
LINE
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~IMITREX STATDOSE~GLAXOSMITHKLINE~E
Q 6MG BASE/0.5ML (EQ 12MG BASE/ML)~N~020080~003~AB~Dec 23, 1996~Yes~RX~GLAXOSMIT
HKLINE
MECASERMIN RECOMBINANT~INJECTABLE;SUBCUTANEOUS~INCRELEX~IPSEN INC~40MG/4ML (10MG
/ML)~N~021839~001~~Aug 30, 2005~Yes~RX~IPSEN BIOPHARMACEUTICALS INC
MECASERMIN RINFABATE RECOMBINANT~INJECTABLE;SUBCUTANEOUS~IPLEX~INSMED~36MG/0.6ML
~N~021884~001~~Dec 12, 2005~No~DISCN~INSMED INC
DESIRUDIN RECOMBINANT~INJECTABLE;SUBCUTANEOUS~IPRIVASK~MARATHON PHARMS LLC~15MG/
VIAL~N~021271~001~~Apr 4, 2003~Yes~RX~MARATHON PHARMACEUTICALS LLC
INSULIN DETEMIR RECOMBINANT~INJECTABLE;SUBCUTANEOUS~LEVEMIR~NOVO NORDISK INC~100
0 UNITS/10ML (100 UNITS/ML)~N~021536~001~~Jun 16, 2005~Yes~RX~NOVO NORDISK INC
INSULIN DETEMIR RECOMBINANT~INJECTABLE;SUBCUTANEOUS~LEVEMIR FLEXPEN~NOVO NORDISK
INC~300 UNITS/3ML (100 UNITS/ML)~N~021536~002~~Jun 16, 2005~Yes~RX~NOVO NORDISK
INC
INSULIN DETEMIR RECOMBINANT~INJECTABLE;SUBCUTANEOUS~LEVEMIR FLEXTOUCH~NOVO NORDI
SK INC~300 UNITS/3ML (100 UNITS/ML)~N~021536~005~~Oct 31, 2013~Yes~RX~NOVO NORDI
SK INC
INSULIN DETEMIR RECOMBINANT~INJECTABLE;SUBCUTANEOUS~LEVEMIR INNOLET~NOVO NORDISK
INC~300 UNITS/3ML (100 UNITS/ML)~N~021536~003~~Jun 16, 2005~No~DISCN~NOVO NORDI

SK INC
INSULIN DETEMIR RECOMBINANT~INJECTABLE;SUBCUTANEOUS~LEVEMIR PENFILL~NOVO NORDISK
INC~300 UNITS/3ML (100 UNITS/ML)~N~021536~004~~Jun 16, 2005~No~DISCN~NOVO NORDI
SK INC
ENOXAPARIN SODIUM~INJECTABLE;SUBCUTANEOUS~LOVENOX (PRESERVATIVE FREE)~SANOFI AVE
NTIS US~30MG/0.3ML (100MG/ML)~N~020164~001~AP~Mar 29, 1993~No~RX~SANOFI AVENTIS
US LLC
NTIS US~40MG/0.4ML (100MG/ML)~N~020164~002~AP~Jan 30, 1998~No~RX~SANOFI AVENTIS
US LLC
US LLC
US LLC
NTIS US~90MG/0.6ML (150MG/ML) **Federal Register determination that product was
not discontinued or withdrawn for safety or efficacy reasons**~N~020164~006~~Jun
2, 2000~No~DISCN~SANOFI AVENTIS US LLC
NTIS US~100MG/ML (100MG/ML)~N~020164~005~AP~Mar 27, 1998~Yes~RX~SANOFI AVENTIS U
S LLC
NTIS US~120MG/0.8ML (150MG/ML)~N~020164~007~AP~Jun 2, 2000~No~RX~SANOFI AVENTIS
US LLC
NTIS US~150MG/ML (150MG/ML)~N~020164~008~AP~Jun 2, 2000~No~RX~SANOFI AVENTIS US
LLC
LUTROPIN ALFA~INJECTABLE;SUBCUTANEOUS~LUVERIS~EMD SERONO~75 IU/VIAL~N~021322~001
~~Oct 8, 2004~No~DISCN~EMD SERONO INC
MENOTROPINS (FSH;LH)~INJECTABLE;SUBCUTANEOUS~MENOPUR~FERRING~75 IU/VIAL;75 IU/VI
AL~N~021663~001~~Oct 29, 2004~Yes~RX~FERRING PHARMACEUTICALS INC
INSULIN ASPART RECOMBINANT~INJECTABLE;SUBCUTANEOUS~NOVOLOG~NOVO NORDISK INC~1000
UNITS/10ML (100 UNITS/ML)~N~020986~001~~Jun 7, 2000~Yes~RX~NOVO NORDISK INC
INSULIN ASPART RECOMBINANT~INJECTABLE;SUBCUTANEOUS~NOVOLOG FLEXPEN~NOVO NORDISK
INC~300 UNITS/3ML (100 UNITS/ML)~N~020986~003~~Jan 19, 2001~Yes~RX~NOVO NORDISK
INC
INSULIN ASPART RECOMBINANT~INJECTABLE;SUBCUTANEOUS~NOVOLOG FLEXTOUCH~NOVO NORDIS
K INC~300 UNITS/3ML (100 UNITS/ML)~N~020986~005~~Oct 31, 2013~Yes~RX~NOVO NORDIS
K INC
INSULIN ASPART RECOMBINANT~INJECTABLE;SUBCUTANEOUS~NOVOLOG INNOLET~NOVO NORDISK
INC~300 UNITS/3ML (100 UNITS/ML)~N~020986~004~~Apr 23, 2004~No~DISCN~NOVO NORDIS
K INC
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT~INJECTABLE;SUBC
UTANEOUS~NOVOLOG MIX 50/50~NOVO NORDISK INC~50 UNITS/ML;50 UNITS/ML~N~021810~001
~~Aug 26, 2008~No~DISCN~NOVO NORDISK INC
UTANEOUS~NOVOLOG MIX 70/30~NOVO NORDISK INC~700 UNITS/10ML; 300 UNITS/10ML (70 U
NITS/ML; 30 UNITS/ML)~N~021172~001~~Nov 1, 2001~Yes~RX~NOVO NORDISK INC
UTANEOUS~NOVOLOG MIX 70/30 FLEXPEN~NOVO NORDISK INC~210 UNITS/3ML; 90 UNITS/3ML
(70 UNITS/ML; 30 UNITS/ML)~N~021172~004~~May 3, 2002~Yes~RX~NOVO NORDISK INC
UTANEOUS~NOVOLOG MIX 70/30 PENFILL~NOVO NORDISK INC~210 UNITS/3ML;90 UNITS/3ML (
70 UNITS/ML; 30 UNITS/ML)~N~021172~002~~Nov 1, 2001~No~DISCN~NOVO NORDISK INC
UTANEOUS~NOVOLOG MIX 70/30 PENFILL~NOVO NORDISK INC~210 UNITS/3ML;90 UNITS/3ML (
70 UNITS/ML; 30 UNITS/ML)~N~021172~003~~Nov 1, 2001~No~DISCN~NOVO NORDISK INC
INSULIN ASPART RECOMBINANT~INJECTABLE;SUBCUTANEOUS~NOVOLOG PENFILL~NOVO NORDISK

INC~300 UNITS/3ML (100 UNITS/ML)~N~020986~002~~Jun 7, 2000~Yes~RX~NOVO NORDISK I
NC
CHORIOGONADOTROPIN ALFA~INJECTABLE;SUBCUTANEOUS~OVIDREL~EMD SERONO~EQ 0.25MG /0.
5ML~N~021149~002~~Oct 6, 2003~Yes~RX~EMD SERONO INC
METHYLNALTREXONE BROMIDE~INJECTABLE;SUBCUTANEOUS~RELISTOR~SALIX PHARMS~8MG/0.4ML
(8MG/0.4ML)~N~021964~002~~Sep 27, 2010~No~RX~SALIX PHARMACEUTICALS INC
METHYLNALTREXONE BROMIDE~INJECTABLE;SUBCUTANEOUS~RELISTOR~SALIX PHARMS~12MG/0.6M
L (12MG/0.6ML)~N~021964~003~~Apr 24, 2008~Yes~RX~SALIX PHARMACEUTICALS INC
SOMATROPIN RECOMBINANT~INJECTABLE;SUBCUTANEOUS~SEROSTIM LQ~EMD SERONO~6MG/0.5ML
(6MG/0.5ML)~N~020604~005~~Feb 11, 2005~No~DISCN~EMD SERONO INC
PEGVISOMANT~INJECTABLE;SUBCUTANEOUS~SOMAVERT~PHARMACIA AND UPJOHN~10MG/VIAL~N~02
1106~001~~Mar 25, 2003~Yes~RX~PHARMACIA AND UPJOHN CO
1106~004~~Jul 31, 2014~Yes~RX~PHARMACIA AND UPJOHN CO
1106~005~~Jul 31, 2014~Yes~RX~PHARMACIA AND UPJOHN CO
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~AGILA SPECLT
S~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~203322~001~AP~Apr 14, 2014~No~RX~AGILA S
PECIALTIES PRIVATE LTD
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~AUROBINDO PH
ARMA LTD~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~202758~001~AP~Apr 23, 2013~No~RX~
AUROBINDO PHARMA LTD
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~BEDFORD~EQ 6
MG BASE/0.5ML (EQ 12MG BASE/ML)~A~079123~001~AP~Feb 6, 2009~No~RX~BEDFORD LABORA
TORIES DIV BEN VENUE LABORATORIES INC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~DR REDDYS LA
BS INC~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~090495~001~AB~Jan 29, 2014~No~RX~DR
REDDYS LABORATORIES INC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~FRESENIUS KA
BI USA~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~079242~001~AP~Mar 2, 2009~No~RX~FRE
SENIUS KABI USA LLC
BI USA~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~079240~002~~Sep 18, 2009~No~DISCN~F
BI USA~EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)~A~079240~001~~Sep 18, 2009~No~DISCN~FR
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~HIKMA FARMAC
EUTICA~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~200183~001~AP~Sep 16, 2013~No~RX~HI
KMA FARMACEUTICA PORTUGAL SA
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~INJECTALIA~E
Q 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~090310~001~AP~Aug 11, 2010~No~RX~INJECTALIA
SRL
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~PAR PHARM~EQ
6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~077332~001~AP~Oct 9, 2009~No~RX~PAR PHARMACE
UTICAL INC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~PAR STERILE
PRODUCTS~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~077871~001~AP~Jul 9, 2009~No~RX~P
AR STERILE PRODUCTS LLC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~SAGENT AGILA
~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~090641~001~AP~Jul 28, 2010~No~RX~SAGENT A
GILA LLC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~SAGENT STRID
ES~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~090314~001~AP~Jun 10, 2010~No~RX~SAGENT
STRIDES LLC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~SANDOZ~EQ 4M

G BASE/0.5ML (EQ 8MG BASE/ML)~A~078067~002~~Feb 6, 2009~No~DISCN~SANDOZ CANADA I
NC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~SANDOZ~EQ 6M
G BASE/0.5ML (EQ 12MG BASE/ML)~A~078067~001~~Feb 6, 2009~No~DISCN~SANDOZ CANADA
INC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~SUN PHARMA G
LOBAL~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~090358~001~AB~Jun 21, 2011~No~RX~SUN
PHARMA GLOBAL FZE
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~TEVA PARENTE
RAL~EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)~A~078318~001~~Feb 6, 2009~No~DISCN~TEVA P
ARENTERAL MEDICINES INC
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~TEVA PARENTE
RAL~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~078318~002~~Feb 6, 2009~No~DISCN~TEVA
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~TEVA PHARMS
USA~EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~077907~001~AP~Feb 6, 2009~No~RX~TEVA P
HARMACEUTICALS USA
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMATRIPTAN SUCCINATE~WOCKHARDT~EQ
6MG BASE/0.5ML (EQ 12MG BASE/ML)~A~078593~001~AP~Feb 6, 2009~No~RX~WOCKHARDT LT
D
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMAVEL DOSEPRO~ENDO VENTURES LTD~
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)~N~022239~002~BX~Nov 26, 2013~Yes~RX~ENDO VENT
URES LTD IRELAND
SUMATRIPTAN SUCCINATE~INJECTABLE;SUBCUTANEOUS~SUMAVEL DOSEPRO~ENDO VENTURES LTD~
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)~N~022239~001~BX~Jul 15, 2009~Yes~RX~ENDO VEN
TURES LTD IRELAND
PRAMLINTIDE ACETATE~INJECTABLE;SUBCUTANEOUS~SYMLIN~ASTRAZENECA AB~EQ 1.5MG BASE/
1.5ML (EQ 1MG BASE/ML)~N~021332~002~~Sep 25, 2007~No~RX~ASTRAZENECA AB
PRAMLINTIDE ACETATE~INJECTABLE;SUBCUTANEOUS~SYMLIN~ASTRAZENECA AB~EQ 2.7MG BASE/
2.7ML (EQ 1MG BASE/ML)~N~021332~003~~Sep 25, 2007~Yes~RX~ASTRAZENECA AB
PRAMLINTIDE ACETATE~INJECTABLE;SUBCUTANEOUS~SYMLIN~ASTRAZENECA AB~EQ 3MG BASE/5M
L (EQ 600MCG BASE/ML)~N~021332~001~~Mar 16, 2005~No~DISCN~ASTRAZENECA AB
PROGESTERONE~INSERT, EXTENDED RELEASE;INTRAUTERINE~PROGESTASERT~ALZA~38MG~N~0175
53~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALZA CORP
PILOCARPINE~INSERT, EXTENDED RELEASE;OPHTHALMIC~OCUSERT PILO-20~AKORN~5MG~N~0174
PILOCARPINE~INSERT, EXTENDED RELEASE;OPHTHALMIC~OCUSERT PILO-40~AKORN~11MG~N~017
DINOPROSTONE~INSERT, EXTENDED RELEASE;VAGINAL~CERVIDIL~FERRING CONTROLLED~10MG~N
~020411~001~~Mar 30, 1995~Yes~RX~FERRING CONTROLLED THERAPEUTICS LTD
ESTRADIOL~INSERT, EXTENDED RELEASE;VAGINAL~ESTRING~PHARMACIA AND UPJOHN~0.0075MG
/24HR~N~020472~001~~Apr 26, 1996~Yes~RX~PHARMACIA AND UPJOHN CO
ESTRADIOL ACETATE~INSERT, EXTENDED RELEASE;VAGINAL~FEMRING~WARNER IRELAND~EQ 0.0
5MG BASE/24HR~N~021367~001~~Mar 20, 2003~No~RX~WARNER CHILCOTT IRELAND LTD
ESTRADIOL ACETATE~INSERT, EXTENDED RELEASE;VAGINAL~FEMRING~WARNER IRELAND~EQ 0.1
MG BASE/24HR~N~021367~002~~Mar 20, 2003~Yes~RX~WARNER CHILCOTT IRELAND LTD
HYDROXYPROPYL CELLULOSE~INSERT;OPHTHALMIC~LACRISERT~ATON~5MG~N~018771~001~~Appro
ved Prior to Jan 1, 1982~Yes~RX~ATON PHARMA INC
PROGESTERONE~INSERT;VAGINAL~ENDOMETRIN~FERRING~100MG~N~022057~001~~Jun 21, 2007~
Yes~RX~FERRING PHARMACEUTICALS INC
COPPER~INTRAUTERINE DEVICE;INTRAUTERINE~CU-7~GD SEARLE LLC~89MG~N~017408~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
LEVONORGESTREL~INTRAUTERINE DEVICE;INTRAUTERINE~LILETTA~MEDICINES360~52MG~N~2062
29~001~~Feb 26, 2015~No~RX~MEDICINES360
LEVONORGESTREL~INTRAUTERINE DEVICE;INTRAUTERINE~MIRENA~BAYER HLTHCARE~52MG~N~021
225~001~~Dec 6, 2000~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
COPPER~INTRAUTERINE DEVICE;INTRAUTERINE~PARAGARD T 380A~TEVA WOMENS~309MG/COPPER
~N~018680~001~~Nov 15, 1984~Yes~RX~TEVA WOMENS HEALTH INC
LEVONORGESTREL~INTRAUTERINE DEVICE;INTRAUTERINE~SKYLA~BAYER HLTHCARE~13.5MG~N~20
3159~001~~Jan 9, 2013~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC

COPPER~INTRAUTERINE DEVICE;INTRAUTERINE~TATUM-T~GD SEARLE LLC~120MG~N~018205~001
~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
LIDOCAINE HYDROCHLORIDE~JELLY;TOPICAL~ANESTACON~BANNER LIFE SCIENCES~2%~A~080429
~001~~Approved Prior to Jan 1, 1982~No~DISCN~BANNER LIFE SCIENCES LLC
LIDOCAINE HYDROCHLORIDE~JELLY;TOPICAL~GLYDO~SAGENT PHARMS~2%~A~201094~001~AT~Apr
28, 2014~No~RX~SAGENT PHARMACEUTICALS INC
LIDOCAINE HYDROCHLORIDE~JELLY;TOPICAL~LIDOCAINE HYDROCHLORIDE~AKORN~2%~A~040433~
001~AT~Feb 12, 2003~No~RX~AKORN INC
LIDOCAINE HYDROCHLORIDE~JELLY;TOPICAL~LIDOCAINE HYDROCHLORIDE~INTL MEDICATION~2%
~A~086283~001~AT~Approved Prior to Jan 1, 1982~No~RX~INTERNATIONAL MEDICATION SY
STEM
LIDOCAINE HYDROCHLORIDE~JELLY;TOPICAL~LIDOCAINE HYDROCHLORIDE~TEVA PHARMS USA~2%
~A~081318~001~~Apr 29, 1993~No~DISCN~TEVA PHARMACEUTICALS USA
LIDOCAINE HYDROCHLORIDE~JELLY;TOPICAL~LIDOCAINE HYDROCHLORIDE~WATSON LABS INC~2%
~A~040837~001~AT~Mar 23, 2011~No~RX~WATSON LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~JELLY;TOPICAL~XYLOCAINE~OAK PHARMS~2%~N~008816~001~AT~Ap
proved Prior to Jan 1, 1982~Yes~RX~OAK PHARMACEUTICALS INC
ENFLURANE~LIQUID;INHALATION~ENFLURANE~ABBOTT~99.9%~A~070803~001~~Sep 8, 1987~No~
DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
ENFLURANE~LIQUID;INHALATION~ENFLURANE~PIRAMAL CRITICAL~99.9%~A~074396~001~AN~Jul
29, 1994~No~RX~PIRAMAL CRITICAL CARE INC
ENFLURANE~LIQUID;INHALATION~ETHRANE~BAXTER HLTHCARE~99.9%~N~017087~001~AN~Approv
ed Prior to Jan 1, 1982~Yes~RX~BAXTER HEALTHCARE CORP
HALOTHANE~LIQUID;INHALATION~FLUOTHANE~WYETH AYERST~99.99%~N~011338~001~~Approved
Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
ISOFLURANE~LIQUID;INHALATION~FORANE~BAXTER HLTHCARE~99.9%~N~017624~001~AN~Approv
ed Prior to Jan 1, 1982~Yes~RX~BAXTER HEALTHCARE CORP
HALOTHANE~LIQUID;INHALATION~HALOTHANE~BH~99.99%~A~084977~001~~Approved Prior to
Jan 1, 1982~No~DISCN~BH CHEMICALS INC
HALOTHANE~LIQUID;INHALATION~HALOTHANE~HALOCARBON~99.99%~A~080810~001~~Approved P
rior to Jan 1, 1982~No~DISCN~HALOCARBON LABORATORIES DIV HALOCARBON PRODUCTS COR
P
HALOTHANE~LIQUID;INHALATION~HALOTHANE~HOSPIRA~99.99%~A~083254~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~HOSPIRA INC
ISOFLURANE~LIQUID;INHALATION~ISOFLURANE~HALOCARBON PRODS~99.9%~A~075225~001~AN~O
ct 20, 1999~No~RX~HALOCARBON PRODUCTS CORP
ISOFLURANE~LIQUID;INHALATION~ISOFLURANE~HOSPIRA~99.9%~A~074097~001~AN~Jan 25, 19
ISOFLURANE~LIQUID;INHALATION~ISOFLURANE~PIRAMAL CRITICAL~99.9%~A~074416~001~AN~S
ep 30, 1994~No~RX~PIRAMAL CRITICAL CARE INC
ISOFLURANE~LIQUID;INHALATION~ISOFLURANE~PIRAMAL ENT~99.9%~A~074502~001~AN~Jun 27
, 1995~No~RX~PIRAMAL ENTERPRISES LTD
ISOFLURANE~LIQUID;INHALATION~ISOFLURANE~WATSON LABS INC~99.9%~A~074393~001~~May
SEVOFLURANE~LIQUID;INHALATION~SEVOFLURANE~BAXTER HLTHCARE~100%~A~075895~001~AN~J
ul 2, 2002~No~RX~BAXTER HEALTHCARE CORP
SEVOFLURANE~LIQUID;INHALATION~SEVOFLURANE~HALOCARBON PRODS~100%~A~078650~001~AN~
Nov 19, 2007~No~RX~HALOCARBON PRODUCTS CORP
SEVOFLURANE~LIQUID;INHALATION~SOJOURN~PIRAMAL CRITICAL~100%~A~077867~001~AN~May
2, 2007~No~RX~PIRAMAL CRITICAL CARE INC
DESFLURANE~LIQUID;INHALATION~SUPRANE~BAXTER HLTHCARE~99.9%~N~020118~001~~Sep 18,
1992~Yes~RX~BAXTER HEALTHCARE CORP
SEVOFLURANE~LIQUID;INHALATION~ULTANE~ABBVIE~100%~N~020478~001~AN~Jun 7, 1995~Yes
~RX~ABBVIE INC
STERILE WATER FOR IRRIGATION~LIQUID;IRRIGATION~STERILE WATER~BAXTER HLTHCARE~100
%~N~017428~001~AT~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
STERILE WATER FOR IRRIGATION~LIQUID;IRRIGATION~STERILE WATER IN PLASTIC CONTAINE
R~B BRAUN~100%~N~016734~001~AT~Approved Prior to Jan 1, 1982~No~RX~B BRAUN MEDIC
AL INC

R~BAXTER HLTHCARE~100%~N~017866~001~AT~Approved Prior to Jan 1, 1982~No~RX~BAXTE
R HEALTHCARE CORP
R~HOSPIRA~100%~N~017513~001~AT~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
R~HOSPIRA~100%~N~018313~001~AT~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
R~MILES~100%~N~018246~001~~Approved Prior to Jan 1, 1982~No~DISCN~MILES LABORATO
RIES INC
STERILE WATER FOR INJECTION~LIQUID;N/A~BACTERIOSTATIC WATER FOR INJECTION IN PLA
STIC CONTAINER~ABRAXIS PHARM~100%~A~089099~001~~Dec 29, 1987~No~DISCN~ABRAXIS PH
STIC CONTAINER~ABRAXIS PHARM~100%~A~089100~001~~Dec 29, 1987~No~DISCN~ABRAXIS PH
STIC CONTAINER~HOSPIRA~100%~N~018802~001~AP~Oct 27, 1982~Yes~RX~HOSPIRA INC
STERILE WATER FOR INJECTION~LIQUID;N/A~STERILE WATER FOR INJECTION IN PLASTIC CO
NTAINER~B BRAUN~100%~N~019077~001~~Mar 2, 1984~No~DISCN~B BRAUN MEDICAL INC
NTAINER~B BRAUN~100%~N~019633~001~AP~Feb 29, 1988~Yes~RX~B BRAUN MEDICAL INC
NTAINER~BAXTER HLTHCARE~100%~N~018632~001~AP~Jun 30, 1982~Yes~RX~BAXTER HEALTHCA
RE CORP
NTAINER~BAXTER HLTHCARE~100%~N~018632~002~AP~Apr 19, 1988~Yes~RX~BAXTER HEALTHCA
RE CORP
NTAINER~FRESENIUS KABI USA~100%~A~088400~001~AP~Jan 16, 1984~No~RX~FRESENIUS KAB
I USA LLC
NTAINER~HOSPIRA~100%~N~018233~001~AP~Approved Prior to Jan 1, 1982~Yes~RX~HOSPIR
A INC
NTAINER~HOSPIRA~100%~N~018801~001~AP~Oct 27, 1982~Yes~RX~HOSPIRA INC
NTAINER~HOSPIRA~100%~N~019869~001~AP~Dec 26, 1989~Yes~RX~HOSPIRA INC
NTAINER~TARO PHARMS IRELAND~100%~A~077393~001~AP~Aug 11, 2006~No~RX~TARO PHARMAC
EUTICALS IRELAND LTD
DIMENHYDRINATE~LIQUID;ORAL~DIMENHYDRINATE~ALRA~12.5MG/4ML~A~080715~001~~Approved
Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
PERFLUBRON~LIQUID;ORAL~IMAGENT~ALLIANCE PHARM~100%~N~020091~001~~Aug 13, 1993~No
~DISCN~ALLIANCE PHARMACEUTICAL CORP
GLYCEROL PHENYLBUTYRATE~LIQUID;ORAL~RAVICTI~HYPERION THERAP INC~1.1GM/ML~N~20328
4~001~~Feb 1, 2013~Yes~RX~HYPERION THERAPEUTICS INC
MONOCTANOIN~LIQUID;PERFUSION, BILIARY~MOCTANIN~ETHITEK~100%~N~019368~001~~Oct 29
, 1985~No~DISCN~ETHITEK PHARMACEUTICALS CO
BETAMETHASONE DIPROPIONATE~LOTION, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~
FOUGERA PHARMS~EQ 0.05% BASE~A~077111~001~AB~May 21, 2007~No~RX~FOUGERA PHARMACE
UTICALS INC
BETAMETHASONE DIPROPIONATE~LOTION, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONATE~
TARO~EQ 0.05% BASE~A~077477~001~AB~May 21, 2007~No~RX~TARO PHARMACEUTICALS USA I
NC
BETAMETHASONE DIPROPIONATE~LOTION, AUGMENTED;TOPICAL~DIPROLENE~MERCK SHARP DOHME
~EQ 0.05% BASE~N~019716~001~AB~Aug 1, 1988~Yes~RX~MERCK SHARP AND DOHME CORP
SELENIUM SULFIDE~LOTION/SHAMPOO;TOPICAL~EXSEL~ALLERGAN HERBERT~2.5%~A~083892~001
~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN HERBERT DIV ALLERGAN INC
SELENIUM SULFIDE~LOTION/SHAMPOO;TOPICAL~SELENIUM SULFIDE~ACTAVIS MID ATLANTIC~2.
5%~A~084394~001~~Approved Prior to Jan 1, 1982~No~DISCN~ACTAVIS MID ATLANTIC LLC

SELENIUM SULFIDE~LOTION/SHAMPOO;TOPICAL~SELENIUM SULFIDE~G AND W LABS INC~2.5%~A
~086209~001~~Approved Prior to Jan 1, 1982~No~DISCN~G AND W LABORATORIES INC
SELENIUM SULFIDE~LOTION/SHAMPOO;TOPICAL~SELENIUM SULFIDE~IVAX PHARMS~2.5%~A~0857
77~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
SELENIUM SULFIDE~LOTION/SHAMPOO;TOPICAL~SELENIUM SULFIDE~PERRIGO NEW YORK~2.5%~A
~089996~001~AT~Jan 10, 1991~No~RX~PERRIGO NEW YORK INC
SELENIUM SULFIDE~LOTION/SHAMPOO;TOPICAL~SELENIUM SULFIDE~WOCKHARDT~2.5%~A~088228
~001~AT~Sep 1, 1983~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
SELENIUM SULFIDE~LOTION/SHAMPOO;TOPICAL~SELSUN~CHATTEM~2.5%~N~007936~001~AT~Appr
oved Prior to Jan 1, 1982~Yes~RX~CHATTEM INC
HYDROCORTISONE~LOTION;TOPICAL~ACTICORT~BAKER NORTON~1%~A~086535~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~BAKER NORTON PHARMACEUTICALS INC
HYDROCORTISONE~LOTION;TOPICAL~ALA-CORT~CROWN LABS~1%~A~083201~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~CROWN LABORATORIES INC
HYDROCORTISONE~LOTION;TOPICAL~ALA-SCALP~CROWN LABS~2%~A~083231~001~~Approved Pri
or to Jan 1, 1982~No~RX~CROWN LABORATORIES INC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~ALPHATREX~SAVAGE LABS~EQ 0.05% BASE~A~
070273~001~~Aug 12, 1985~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
AMCINONIDE~LOTION;TOPICAL~AMCINONIDE~FOUGERA PHARMS~0.1%~A~076329~001~~Nov 6, 20
AMMONIUM LACTATE~LOTION;TOPICAL~AMMONIUM LACTATE~PERRIGO NEW YORK~EQ 12% BASE~A~
075570~001~AB~Jun 23, 2004~No~RX~PERRIGO NEW YORK INC
AMMONIUM LACTATE~LOTION;TOPICAL~AMMONIUM LACTATE~TARO~EQ 12% BASE~A~076216~001~A
B~May 28, 2004~No~RX~TARO PHARMACEUTICALS USA INC
AMMONIUM LACTATE~LOTION;TOPICAL~AMMONIUM LACTATE~WATSON LABS INC~EQ 12% BASE~A~0
HYDROCORTISONE~LOTION;TOPICAL~BALNEOL-HC~SOLVAY~1%~A~088041~001~~Dec 3, 1982~No~
DISCN~SOLVAY PHARMACEUTICALS
HYDROCORTISONE~LOTION;TOPICAL~BETA-HC~BETA DERMAC~1%~A~089495~001~~Jan 25, 1988~
No~DISCN~BETA DERMACEUTICALS INC
BETAMETHASONE VALERATE~LOTION;TOPICAL~BETA-VAL~TEVA~EQ 0.1% BASE~A~070072~001~AB
~Jun 27, 1985~No~RX~TEVA PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~ACTAVIS MID
ATLANTIC~EQ 0.05% BASE~A~070281~001~AB~Jul 31, 1985~No~RX~ACTAVIS MID ATLANTIC
LLC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~ALPHARMA US
PHARMS~EQ 0.05% BASE~A~071085~001~~Feb 3, 1987~No~DISCN~ALPHARMA US PHARMACEUTI
CALS DIVISION
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~FOUGERA~EQ
0.05% BASE~A~070275~001~AB~Aug 12, 1985~Yes~RX~E FOUGERA DIV ALTANA INC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~PERRIGO NEW
YORK~EQ 0.05% BASE~A~072538~001~AB~Jan 31, 1990~No~RX~PERRIGO NEW YORK INC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~PHARMADERM~
EQ 0.05% BASE~A~070274~001~~Aug 12, 1985~No~DISCN~PHARMADERM DIV ALTANA INC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~TARO~EQ 0.0
5% BASE~A~072276~001~~Aug 24, 1988~No~DISCN~TARO PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~TARO~EQ 0.0
5% BASE~A~074272~001~~Sep 30, 1994~No~DISCN~TARO PHARMACEUTICALS INC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~TEVA~EQ 0.0
5% BASE~A~071467~001~AB~Aug 10, 1987~No~RX~TEVA PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~BETAMETHASONE DIPROPIONATE~TEVA PHARMS
~EQ 0.05% BASE~A~071882~001~~Jun 6, 1988~No~DISCN~TEVA PHARMACEUTICALS USA
BETAMETHASONE VALERATE~LOTION;TOPICAL~BETAMETHASONE VALERATE~FOUGERA~EQ 0.1% BAS
E~N~018866~001~AB~Aug 31, 1983~Yes~RX~E FOUGERA DIV ALTANA INC
BETAMETHASONE VALERATE~LOTION;TOPICAL~BETAMETHASONE VALERATE~PHARMADERM~EQ 0.1%
BASE~N~018870~001~~Aug 31, 1983~No~DISCN~PHARMADERM DIV ALTANA INC
BETAMETHASONE VALERATE~LOTION;TOPICAL~BETAMETHASONE VALERATE~PHARMAFAIR~EQ 0.1%
BASE~A~070484~001~~May 29, 1987~No~DISCN~PHARMAFAIR INC
BETAMETHASONE VALERATE~LOTION;TOPICAL~BETAMETHASONE VALERATE~STI PHARMA LLC~EQ 0
.1% BASE~A~070052~001~AB~Jul 31, 1985~No~RX~STI PHARMA LLC

BETAMETHASONE VALERATE~LOTION;TOPICAL~BETAMETHASONE VALERATE~TEVA PHARMS~EQ 0.1%
BASE~A~071883~001~~Apr 22, 1988~No~DISCN~TEVA PHARMACEUTICALS USA
BETAMETHASONE VALERATE~LOTION;TOPICAL~BETATREX~SAVAGE LABS~EQ 0.1% BASE~N~018867
~001~~Aug 31, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
NYSTATIN~LOTION;TOPICAL~CANDEX~BAYER PHARMS~100,000 UNITS/ML~N~050233~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
HYDROCORTISONE~LOTION;TOPICAL~CETACORT~DOW PHARM~0.5%~A~080426~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL SCIENCES
HYDROCORTISONE~LOTION;TOPICAL~CETACORT~DOW PHARM~1%~A~080426~001~~Approved Prior
to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL SCIENCES
CLINDAMYCIN PHOSPHATE~LOTION;TOPICAL~CLEOCIN T~PHARMACIA AND UPJOHN~EQ 1% BASE~N
~050600~001~AB~May 31, 1989~Yes~RX~PHARMACIA AND UPJOHN CO
CLINDAMYCIN PHOSPHATE~LOTION;TOPICAL~CLINDAMYCIN PHOSPHATE~FOUGERA PHARMS~EQ 1%
BASE~A~065067~001~AB~Jan 31, 2002~No~RX~FOUGERA PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~LOTION;TOPICAL~CLOBETASOL PROPIONATE~ACTAVIS MID ATLANTIC~
0.05%~A~078223~001~AB~Dec 4, 2008~No~RX~ACTAVIS MID ATLANTIC LLC
CLOBETASOL PROPIONATE~LOTION;TOPICAL~CLOBETASOL PROPIONATE~TARO~0.05%~A~200302~0
01~AB~Jul 2, 2012~No~RX~TARO PHARMACEUTICALS USA INC
CLOBETASOL PROPIONATE~LOTION;TOPICAL~CLOBEX~GALDERMA LABS LP~0.05%~N~021535~001~
AB~Jul 24, 2003~Yes~RX~GALDERMA LABORATORIES L P
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE~LOTION;TOPICAL~CLOTRIMAZOLE AND BETAMET
HASONE DIPROPIONATE~FOUGERA PHARMS~EQ 0.05% BASE;1%~A~076516~001~AB~Jun 16, 2005
~No~RX~FOUGERA PHARMACEUTICALS INC
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE~LOTION;TOPICAL~CLOTRIMAZOLE AND BETAMET
HASONE DIPROPIONATE~TARO~EQ 0.05% BASE;1%~A~076493~001~AB~Jul 28, 2004~No~RX~TAR
O PHARMACEUTICALS USA INC
FLURANDRENOLIDE~LOTION;TOPICAL~CORDRAN~AQUA PHARMS~0.05%~N~013790~001~~Approved
Prior to Jan 1, 1982~Yes~RX~AQUA PHARMACEUTICALS
HYDROCORTISONE~LOTION;TOPICAL~CORT-DOME~BAYER PHARMS~0.5%~N~009895~003~~Approved
HYDROCORTISONE~LOTION;TOPICAL~CORT-DOME~BAYER PHARMS~1%~N~009895~001~~Approved P
rior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
CROTAMITON~LOTION;TOPICAL~CROTAN~SUMMERS~10%~A~087204~001~AT~Approved Prior to J
an 1, 1982~No~RX~SUMMERS LABORATORIES INC
FLUTICASONE PROPIONATE~LOTION;TOPICAL~CUTIVATE~FOUGERA PHARMS~0.05%~N~021152~001
~AB~Mar 31, 2005~Yes~RX~FOUGERA PHARMACEUTICALS INC
AMCINONIDE~LOTION;TOPICAL~CYCLOCORT~ASTELLAS~0.1%~N~019729~001~~Jun 13, 1988~No~
DISCN~ASTELLAS PHARMA US INC
HYDROCORTISONE~LOTION;TOPICAL~DERMACORT~SOLVAY~0.5%~A~084573~002~~Approved Prior
to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
HYDROCORTISONE~LOTION;TOPICAL~DERMACORT~SOLVAY~1%~A~086462~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
DESONIDE~LOTION;TOPICAL~DESONIDE~FOUGERA PHARMS~0.05%~A~075860~001~AB~Mar 19, 20
DESONIDE~LOTION;TOPICAL~DESONIDE~TARO~0.05%~A~202161~001~AB~Oct 31, 2014~No~RX~T
ARO PHARMACEUTICAL INDUSTRIES LTD
DESONIDE~LOTION;TOPICAL~DESOWEN~GALDERMA LABS LP~0.05%~A~072354~001~AB~Jan 24, 1
ADAPALENE~LOTION;TOPICAL~DIFFERIN~GALDERMA LABS LP~0.1%~N~022502~001~~Mar 17, 20
BETAMETHASONE DIPROPIONATE~LOTION;TOPICAL~DIPROSONE~SCHERING~EQ 0.05% BASE~N~017
H CORP
HYDROCORTISONE ACETATE~LOTION;TOPICAL~DRICORT~INGRAM PHARM~0.5%~A~086207~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~INGRAM PHARMACEUTICAL CO
ERYTHROMYCIN~LOTION;TOPICAL~E-SOLVE 2~SYOSSET~2%~A~062467~001~~Jul 3, 1985~No~DI
SCN~SYOSSET LABORATORIES INC
MOMETASONE FUROATE~LOTION;TOPICAL~ELOCON~MERCK SHARP DOHME~0.1%~N~019796~001~AB~
Mar 30, 1989~Yes~RX~MERCK SHARP AND DOHME CORP
HYDROCORTISONE~LOTION;TOPICAL~EPICORT~BLULINE~0.5%~A~083219~002~~Approved Prior
to Jan 1, 1982~No~DISCN~BLULINE LABORATORIES INC
CROTAMITON~LOTION;TOPICAL~EURAX~RANBAXY~10%~N~009112~003~AT~Approved Prior to Ja
n 1, 1982~Yes~RX~RANBAXY LABORATORIES INC
FLURANDRENOLIDE~LOTION;TOPICAL~FLURANDRENOLIDE~ALPHARMA US PHARMS~0.05%~A~087203
~001~~Apr 29, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
FLUTICASONE PROPIONATE~LOTION;TOPICAL~FLUTICASONE PROPIONATE~GLENMARK GENERICS~0
.05%~A~090759~001~AB~May 2, 2011~No~RX~GLENMARK GENERICS LIMITED
FLUTICASONE PROPIONATE~LOTION;TOPICAL~FLUTICASONE PROPIONATE~PERRIGO ISRAEL~0.05
%~A~091553~001~AB~Jul 30, 2013~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
AMPHOTERICIN B~LOTION;TOPICAL~FUNGIZONE~APOTHECON~3%~A~060570~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
LINDANE~LOTION;TOPICAL~GAMENE~SOLA BARNES HIND~1%~A~084989~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~SOLA BARNES HIND
HYDROCORTISONE~LOTION;TOPICAL~GLYCORT~HERAN~1%~A~087489~001~~Oct 3, 1983~No~DISC
N~HERAN PHARMACEUTICAL INC
HYDROCORTISONE~LOTION;TOPICAL~H-CORT~PHARM ASSOC~0.5%~A~086824~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
PYRITHIONE ZINC~LOTION;TOPICAL~HEAD & SHOULDERS CONDITIONER~WARNER CHILCOTT~0.3%
~N~019412~002~~Mar 10, 1986~No~DISCN~WARNER CHILCOTT CO LLC
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~ALPHARMA US PHARMS~0.5%~A~087317~00
1~~Jun 7, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~ALPHARMA US PHARMS~1%~A~087315~001~
~Jun 7, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~FOUGERA PHARMS~2.5%~A~040351~001~AT
~Jul 25, 2000~Yes~RX~FOUGERA PHARMACEUTICALS INC
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~MERICON~0.5%~A~085282~001~~Approved
Prior to Jan 1, 1982~No~DISCN~MERICON INDUSTRIES INC
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~MERICON~1%~A~085282~002~~Feb 26, 19
87~No~DISCN~MERICON INDUSTRIES INC
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~NASKA~1%~A~089705~001~~Apr 25, 1988
~No~DISCN~NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~PERRIGO NEW YORK~0.5%~A~085662~001~
~Approved Prior to Jan 1, 1982~No~DISCN~PERRIGO NEW YORK INC
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~PERRIGO NEW YORK~1%~A~085663~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~PERRIGO NEW YORK INC
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~TARO~1%~A~089024~001~~Feb 12, 1986~
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~TARO~2.5%~A~040247~001~AT~Jul 23, 1
HYDROCORTISONE~LOTION;TOPICAL~HYDROCORTISONE~VINTAGE PHARMS~2.5%~A~040417~001~AT
~Jul 30, 2003~No~RX~VINTAGE PHARMACEUTICALS INC
HYDROCORTISONE~LOTION;TOPICAL~HYTONE~VALEANT INTL~1%~A~080473~003~~Approved Prio
r to Jan 1, 1982~No~DISCN~VALEANT INTERNATIONAL BARBADOS SRL
HYDROCORTISONE~LOTION;TOPICAL~HYTONE~VALEANT INTL~2.5%~A~080473~004~~Nov 30, 198
2~No~DISCN~VALEANT INTERNATIONAL BARBADOS SRL
BENTOQUATAM~LOTION;TOPICAL~IVY BLOCK~STAND HOMEOPATH~5%~N~020532~001~~Aug 26, 19
96~Yes~OTC~STANDARD HOMEOPATHIC CO
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~KENALOG~DELCOR ASSET CORP~0.025%~A~084343
~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELCOR ASSET CORP
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~KENALOG~DELCOR ASSET CORP~0.025%~N~011602
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~KENALOG~DELCOR ASSET CORP~0.1%~A~084343~0
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~KENALOG~DELCOR ASSET CORP~0.1%~N~011602~0
SULFACETAMIDE SODIUM~LOTION;TOPICAL~KLARON~VALEANT BERMUDA~10%~N~019931~001~AB~D
ec 23, 1996~Yes~RX~VALEANT INTERNATIONAL BERMUDA
LINDANE~LOTION;TOPICAL~KWELL~REED AND CARNRICK~1%~A~084218~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
LINDANE~LOTION;TOPICAL~KWELL~REED AND CARNRICK~1%~N~006309~003~~Approved Prior t

o Jan 1, 1982~No~DISCN~REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
AMMONIUM LACTATE~LOTION;TOPICAL~LAC-HYDRIN~RANBAXY~EQ 12% BASE~N~019155~001~AB~A
pr 24, 1985~Yes~RX~RANBAXY LABORATORIES INC
LINDANE~LOTION;TOPICAL~LINDANE~OLTA PHARMS~1%~A~087313~001~AT~Approved Prior to
Jan 1, 1982~No~RX~OLTA PHARMACEUTICALS CORP
LINDANE~LOTION;TOPICAL~LINDANE~WOCKHARDT~1%~A~088190~001~AT~Aug 16, 1984~Yes~RX~
WOCKHARDT EU OPERATIONS (SWISS) AG
HYDROCORTISONE BUTYRATE~LOTION;TOPICAL~LOCOID~PRECISION DERMAT~0.1%~N~022076~001
~~May 18, 2007~Yes~RX~PRECISION DERMATOLOGY INC
CLOTRIMAZOLE~LOTION;TOPICAL~LOTRIMIN~SCHERING~1%~N~018813~001~~Feb 17, 1984~No~D
ISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE~LOTION;TOPICAL~LOTRISONE~MERCK SHARP DO
HME~EQ 0.05% BASE;1%~N~020010~001~AB~Dec 8, 2000~Yes~RX~MERCK SHARP AND DOHME CO
RP
MALATHION~LOTION;TOPICAL~MALATHION~MYLAN PHARMS INC~0.5%~A~078743~001~~Mar 6, 20
MALATHION~LOTION;TOPICAL~MALATHION~SUVEN LIFE~0.5%~A~091559~001~AT~May 23, 2012~
No~RX~SUVEN LIFE SCIENCES LTD
METRONIDAZOLE~LOTION;TOPICAL~METROLOTION~GALDERMA LABS LP~0.75%~N~020901~001~AB~
Nov 24, 1998~Yes~RX~GALDERMA LABORATORIES LP
METRONIDAZOLE~LOTION;TOPICAL~METRONIDAZOLE~FOUGERA PHARMS~0.75%~A~077197~001~AB~
May 24, 2006~No~RX~FOUGERA PHARMACEUTICALS INC
MOMETASONE FUROATE~LOTION;TOPICAL~MOMETASONE FUROATE~FOUGERA PHARMS~0.1%~A~07591
9~001~AB~Nov 29, 2007~No~RX~FOUGERA PHARMACEUTICALS INC
MOMETASONE FUROATE~LOTION;TOPICAL~MOMETASONE FUROATE~G AND W LABS~0.1%~A~077678~
001~AB~Nov 21, 2007~No~RX~G AND W LABORATORIES INC
MOMETASONE FUROATE~LOTION;TOPICAL~MOMETASONE FUROATE~GLENMARK GENERICS~0.1%~A~09
0506~001~AB~Aug 9, 2010~No~RX~GLENMARK GENERICS LTD
MOMETASONE FUROATE~LOTION;TOPICAL~MOMETASONE FUROATE~PERRIGO~0.1%~A~077180~001~A
B~Apr 6, 2005~No~RX~PERRIGO CO
MOMETASONE FUROATE~LOTION;TOPICAL~MOMETASONE FUROATE~TARO~0.1%~A~076788~001~AB~M
ar 15, 2006~No~RX~TARO PHARMACEUTICALS USA INC
MOMETASONE FUROATE~LOTION;TOPICAL~MOMETASONE FUROATE~TOLMAR~0.1%~A~076499~001~AB
~Nov 21, 2007~No~RX~TOLMAR INC
MICONAZOLE NITRATE~LOTION;TOPICAL~MONISTAT-DERM~INSIGHT PHARMS~2%~N~017739~001~~
Approved Prior to Jan 1, 1982~No~DISCN~INSIGHT PHARMACEUTICALS CORP
PERMETHRIN~LOTION;TOPICAL~NIX~GLAXOSMITHKLINE~1%~N~019435~001~~Mar 31, 1986~No~D
ISCN~GLAXOSMITHKLINE
PERMETHRIN~LOTION;TOPICAL~NIX~MEDTECH PRODUCTS~1%~N~019918~001~~May 2, 1990~Yes~
OTC~MEDTECH PRODUCTS INC
HYDROCORTISONE~LOTION;TOPICAL~NUTRACORT~DOW PHARM~0.5%~A~080443~002~~Approved Pr
ior to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL SCIENCES
HYDROCORTISONE~LOTION;TOPICAL~NUTRACORT~DOW PHARM~1%~A~080443~003~~Approved Prio
r to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL SCIENCES
HYDROCORTISONE~LOTION;TOPICAL~NUTRACORT~DOW PHARM~2.5%~A~087644~001~AT~Aug 24, 1
982~No~RX~DOW PHARMACEUTICAL SCIENCES
MALATHION~LOTION;TOPICAL~OVIDE~TARO PHARMS NORTH~0.5%~N~018613~001~AT~Aug 2, 198
2~Yes~RX~TARO PHARMACEUTICALS NORTH AMERICA INC
OXICONAZOLE NITRATE~LOTION;TOPICAL~OXISTAT~FOUGERA PHARMS~EQ 1% BASE~N~020209~00
1~~Sep 30, 1992~Yes~RX~FOUGERA PHARMACEUTICALS INC
METHOXSALEN~LOTION;TOPICAL~OXSORALEN~VALEANT PHARM INTL~1%~N~009048~002~~Approve
d Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
PERMETHRIN~LOTION;TOPICAL~PERMETHRIN~ACTAVIS MID ATLANTIC~1%~A~075014~001~~Mar 2
8, 2000~No~OTC~ACTAVIS MID ATLANTIC LLC
PERMETHRIN~LOTION;TOPICAL~PERMETHRIN~PERRIGO NEW YORK~1%~A~076090~001~~Dec 20, 2
001~No~OTC~PERRIGO NEW YORK INC
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE~LOTION;TOPICAL~PRAMOSONE~FERNDAL
E LABS~0.5%;1%~A~083213~002~~Approved Prior to Jan 1, 1982~No~DISCN~FERNDALE LAB
ORATORIES INC
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE~LOTION;TOPICAL~PRAMOSONE~SEBELA

IRELAND LTD~1%;1%~A~085980~001~~Approved Prior to Jan 1, 1982~No~RX~SEBELA IRELA
ND LTD
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE~LOTION;TOPICAL~PRAMOSONE~SEBELA
IRELAND LTD~2.5%;1%~A~085979~001~~Approved Prior to Jan 1, 1982~No~RX~SEBELA IRE
LAND LTD
LINDANE~LOTION;TOPICAL~SCABENE~STIEFEL~1%~A~086769~001~~Approved Prior to Jan 1,
1982~No~DISCN~STIEFEL LABORATORIES INC
AVOBENZONE; OCTINOXATE; OXYBENZONE~LOTION;TOPICAL~SHADE UVAGUARD~SCHERING PLOUGH
~3%;7.5%;3%~N~020045~001~~Dec 7, 1992~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCT
S INC
IVERMECTIN~LOTION;TOPICAL~SKLICE~SANOFI PASTEUR INC~0.5%~N~202736~001~~Feb 7, 20
12~Yes~RX~SANOFI PASTEUR INC
HYDROCORTISONE~LOTION;TOPICAL~STIE-CORT~PERRIGO~2.5%~A~089074~001~AT~Nov 26, 198
5~No~RX~PERRIGO CO
HYDROCORTISONE~LOTION;TOPICAL~STIE-CORT~PERRIGO CO~1%~A~089066~001~~Nov 25, 1985
~No~DISCN~PERRIGO CO
SULFACETAMIDE SODIUM~LOTION;TOPICAL~SULFACETAMIDE SODIUM~FOUGERA PHARMS~10%~A~07
7015~001~AB~Nov 17, 2006~No~RX~FOUGERA PHARMACEUTICALS INC
SULFACETAMIDE SODIUM~LOTION;TOPICAL~SULFACETAMIDE SODIUM~PERRIGO CO TENNESSEE~10
%~A~078649~001~AB~Mar 23, 2009~No~RX~PERRIGO CO TENNESSEE INC
SULFACETAMIDE SODIUM~LOTION;TOPICAL~SULFACETAMIDE SODIUM~TARO~10%~A~078668~001~A
B~May 20, 2009~No~RX~TARO PHARMACEUTICALS USA INC
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~ALPHARMA US PHARM
S~0.025%~A~087191~001~~Sep 8, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~ALPHARMA US PHARM
S~0.1%~A~087192~001~~Sep 8, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~FOUGERA PHARMS~0.
025%~A~040467~001~AT~Apr 21, 2003~No~RX~FOUGERA PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~FOUGERA PHARMS~0.
1%~A~040467~002~AT~Apr 21, 2003~No~RX~FOUGERA PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~G AND W LABS INC~
0.1%~A~089129~001~~Aug 14, 1986~No~DISCN~G AND W LABORATORIES INC
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~VERSAPHARM INC~0.
025%~A~202374~001~AT~May 8, 2013~No~RX~VERSAPHARM INC
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~VERSAPHARM INC~0.
1%~A~202374~002~AT~May 8, 2013~No~RX~VERSAPHARM INC
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~VINTAGE~0.1%~A~04
0672~002~AT~Dec 13, 2006~No~RX~VINTAGE PHARMACEUTICALS LLC
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~WOCKHARDT~0.1%~A~
088451~001~AT~Apr 3, 1985~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
TRIAMCINOLONE ACETONIDE~LOTION;TOPICAL~TRIAMCINOLONE ACETONIDE~WOCKHARDT EU OPER
ATN~0.025%~A~088450~001~AT~Apr 1, 1985~Yes~RX~WOCKHARDT EU OPERATIONS SWISS AG
BENZYL ALCOHOL~LOTION;TOPICAL~ULESFIA~SHIONOGI INC~5%~N~022129~001~~Apr 9, 2009~
Yes~RX~SHIONOGI INC
BETAMETHASONE BENZOATE~LOTION;TOPICAL~UTICORT~PARKE DAVIS~0.025%~N~017528~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WA
RNER LAMBERT CO
BETAMETHASONE VALERATE~LOTION;TOPICAL~VALISONE~SCHERING~EQ 0.1% BASE~N~016932~00
CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR~N/A;N/A~CYANOCOBALAMIN CO
57 SCHILLING TEST KIT~MALLINCKRODT~0.1MG;0.5uCi;60MG~N~016635~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58~N/A;N/A~DICOPAC KIT~G
E HEALTHCARE~N/A;N/A;N/A~N~017406~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE
HEALTHCARE
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~N~016089~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
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~N~016090~001~~Approved Prior to Ja

n 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
FLUOCINOLONE ACETONIDE~OIL/DROPS;OTIC~DERMOTIC~HILL DERMAC~0.01%~N~019452~003~AT
~Nov 9, 2005~Yes~RX~HILL DERMACEUTICALS INC
FLUOCINOLONE ACETONIDE~OIL/DROPS;OTIC~FLUOCINOLONE ACETONIDE~IDENTI PHARMS INC~0
.01%~A~091306~001~AT~Oct 17, 2011~No~RX~IDENTI PHARMACEUTICALS INC
ETHIODIZED OIL~OIL;INTRALYMPHATIC, INTRAUTERINE~LIPIODOL~GUERBET~99%~N~009190~00
1~~Approved Prior to Jan 1, 1982~Yes~RX~GUERBET LLC
FLUOCINOLONE ACETONIDE~OIL;TOPICAL~DERMA-SMOOTHE/FS~HILL DERMAC~0.01%~N~019452~0
01~AT~Feb 3, 1988~Yes~RX~HILL DERMACEUTICALS INC
FLUOCINOLONE ACETONIDE~OIL;TOPICAL~DERMA-SMOOTHE/FS~HILL DERMAC~0.01%~N~019452~0
02~AT~Nov 9, 2005~Yes~RX~HILL DERMACEUTICALS INC
FLUOCINOLONE ACETONIDE~OIL;TOPICAL~FLUOCINOLONE ACETONIDE~IDENTI PHARMS INC~0.01
%~A~201759~001~AT~Oct 17, 2011~No~RX~IDENTI PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE~OIL;TOPICAL~FLUOCINOLONE ACETONIDE~IDENTI PHARMS INC~0.01
%~A~201764~001~AT~Oct 17, 2011~No~RX~IDENTI PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE~OIL;TOPICAL~FLUOCINOLONE ACETONIDE~PERRIGO ISRAEL~0.01%~A
~202847~001~AT~Aug 9, 2013~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
FLUOCINOLONE ACETONIDE~OIL;TOPICAL~FLUOCINOLONE ACETONIDE~PERRIGO ISRAEL~0.01%~A
~202848~001~AT~Aug 9, 2013~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
BETAMETHASONE DIPROPIONATE~OINTMENT, AUGMENTED;TOPICAL~BETAMETHASONE DIPROPIONAT
E~ACTAVIS MID ATLANTIC~EQ 0.05% BASE~A~074304~001~AB~Aug 31, 1995~No~RX~ACTAVIS
MID ATLANTIC LLC
E~FOUGERA PHARMS~EQ 0.05% BASE~A~075373~001~AB~Jun 22, 1999~No~RX~FOUGERA PHARMA
CEUTICALS INC
E~TARO~EQ 0.05% BASE~A~076753~001~AB~Oct 12, 2004~No~RX~TARO PHARMACEUTICALS USA
INC
BETAMETHASONE DIPROPIONATE~OINTMENT, AUGMENTED;TOPICAL~DIPROLENE~MERCK SHARP DOH
ME~EQ 0.05% BASE~N~018741~001~AB~Jul 27, 1983~Yes~RX~MERCK SHARP AND DOHME CORP
NITROGLYCERIN~OINTMENT;INTRA-ANAL~RECTIV~FOREST LABS INC~0.4%~N~021359~001~~Jun
MUPIROCIN CALCIUM~OINTMENT;NASAL~BACTROBAN~GLAXOSMITHKLINE~EQ 2% BASE~N~050703~0
01~~Sep 18, 1995~Yes~RX~GLAXOSMITHKLINE
HYDROCORTISONE; TETRACYCLINE HYDROCHLORIDE~OINTMENT;OPHTHALMIC~ACHROMYCIN~LEDERL
E~1.5%;1%~N~050272~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATOR
TETRACYCLINE HYDROCHLORIDE~OINTMENT;OPHTHALMIC~ACHROMYCIN~STORZ~10MG/GM~N~050266
~001~~Approved Prior to Jan 1, 1982~No~DISCN~STORZ OPHTHALMICS INC SUB AMERICAN
CYANAMID CO
CHLORTETRACYCLINE HYDROCHLORIDE~OINTMENT;OPHTHALMIC~AUREOMYCIN~LEDERLE~1%~N~0504
04~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN
CYANAMID CO
BACITRACIN~OINTMENT;OPHTHALMIC~BACIGUENT~PHARMACIA AND UPJOHN~500 UNITS/GM~A~060
BACITRACIN~OINTMENT;OPHTHALMIC~BACITRACIN~LILLY~500 UNITS/GM~A~060687~001~~Appro
BACITRACIN~OINTMENT;OPHTHALMIC~BACITRACIN~PERRIGO CO TENNESSEE~500 UNITS/GM~A~06
1212~001~~Approved Prior to Jan 1, 1982~Yes~RX~PERRIGO CO TENNESSEE INC
BACITRACIN~OINTMENT;OPHTHALMIC~BACITRACIN~PHARMADERM~500 UNITS/GM~A~062158~001~~
Approved Prior to Jan 1, 1982~No~DISCN~PHARMADERM DIV ALTANA INC
BACITRACIN~OINTMENT;OPHTHALMIC~BACITRACIN~PHARMAFAIR~500 UNITS/GM~A~062453~001~~
Mar 28, 1984~No~DISCN~PHARMAFAIR INC
BACITRACIN ZINC; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~BACITRACIN ZINC AND POL
YMYXIN B SULFATE~AKORN~500 UNITS/GM;10,000 UNITS/GM~A~064028~001~AT~Jan 30, 1995
~No~RX~AKORN INC
YMYXIN B SULFATE~BAUSCH AND LOMB~500 UNITS/GM;10,000 UNITS/GM~A~064046~001~AT~Ja
n 26, 1995~Yes~RX~BAUSCH AND LOMB PHARMACEUTICALS INC

YMYXIN B SULFATE~PERRIGO CO TENNESSEE~500 UNITS/GM;10,000 UNITS/GM~A~065022~001~
AT~Feb 27, 2002~No~RX~PERRIGO CO TENNESSEE INC
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~BACIT
RACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE~PHARMAFAIR~400 UNITS/GM;EQ 3.5MG
BASE/GM;10,000 UNITS/GM~A~062386~001~~Sep 9, 1982~No~DISCN~PHARMAFAIR INC
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~BACIT
RACIN-NEOMYCIN-POLYMYXIN~PHARMADERM~400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 UNITS/GM
~A~062167~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMADERM DIV ALTANA INC
BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTME
NT;OPHTHALMIC~BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE~ALTANA~400
UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~060731~002~~Approved Prior to Ja
n 1, 1982~No~DISCN~ALTANA INC
BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTME
NT;OPHTHALMIC~BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE~PERRIGO CO
TENNESSEE~400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~062166~002~~Approv
ed Prior to Jan 1, 1982~Yes~RX~PERRIGO CO TENNESSEE INC
SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~BLEPH-10~ALLERGAN~10%~A~084015~001~~App
roved Prior to Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTICAL
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~BLEPHAMIDE S.O.P.
~ALLERGAN~0.2%;10%~A~087748~001~~Dec 3, 1986~Yes~RX~ALLERGAN PHARMACEUTICAL
SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~CETAMIDE~ALCON~10%~A~080021~001~AT~Appr
oved Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~CETAPRED~ALCON~0.
25%;10%~A~087771~001~~Aug 6, 1993~No~DISCN~ALCON LABORATORIES INC
CHLORAMPHENICOL~OINTMENT;OPHTHALMIC~CHLORAMPHENICOL~ALTANA~1%~A~060133~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ALTANA INC
CHLORAMPHENICOL~OINTMENT;OPHTHALMIC~CHLOROFAIR~PHARMAFAIR~1%~A~062439~001~~Apr 2
1, 1983~No~DISCN~PHARMAFAIR INC
CHLORAMPHENICOL~OINTMENT;OPHTHALMIC~CHLOROMYCETIN~PARKEDALE~1%~N~050156~001~~App
roved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
CHLORAMPHENICOL; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~CHLOROMYXIN~PARKE DAVIS
~1%;10,000 UNITS/GM~N~050203~002~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE D
AVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
CHLORAMPHENICOL~OINTMENT;OPHTHALMIC~CHLOROPTIC S.O.P.~ALLERGAN~1%~A~061187~001~~
Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTICAL
CHLORAMPHENICOL; PREDNISOLONE~OINTMENT;OPHTHALMIC~CHLOROPTIC-P S.O.P.~ALLERGAN~1
%;0.5%~A~061188~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTI
CAL
CIPROFLOXACIN HYDROCHLORIDE~OINTMENT;OPHTHALMIC~CILOXAN~ALCON PHARMS LTD~EQ 0.3%
BASE~N~020369~001~~Mar 30, 1998~Yes~RX~ALCON PHARMACEUTICALS LTD
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
UNITS/GM~N~050416~002~~Approved Prior to Jan 1, 1982~No~DISCN~CITRON PHARMA LLC
DEXAMETHASONE SODIUM PHOSPHATE~OINTMENT;OPHTHALMIC~DECADRON~MERCK~EQ 0.05% PHOSP
HATE~N~011977~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~DEXACID
IN~NOVARTIS~0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~062566~001~~Feb 22, 1985~No~
DISCN~NOVARTIS PHARMACEUTICALS CORP
DEXAMETHASONE SODIUM PHOSPHATE~OINTMENT;OPHTHALMIC~DEXAIR~PHARMAFAIR~EQ 0.05% PH
OSPHATE~A~088071~001~~Dec 28, 1982~No~DISCN~PHARMAFAIR INC
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~DEXASPO
RIN~PHARMAFAIR~0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~062411~001~~May 16, 1983~
No~DISCN~PHARMAFAIR INC
CHLORAMPHENICOL~OINTMENT;OPHTHALMIC~ECONOCHLOR~ALCON~1%~A~061648~001~~Approved P
rior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
ERYTHROMYCIN~OINTMENT;OPHTHALMIC~ERYTHROMYCIN~AKORN~0.5%~A~064030~001~AT~Jul 18,
1996~No~RX~AKORN INC
ERYTHROMYCIN~OINTMENT;OPHTHALMIC~ERYTHROMYCIN~BAUSCH AND LOMB~0.5%~A~064067~001~
AT~Jul 29, 1994~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
ERYTHROMYCIN~OINTMENT;OPHTHALMIC~ERYTHROMYCIN~PERRIGO CO TENNESSEE~0.5%~A~062447
~001~AT~Sep 26, 1983~Yes~RX~PERRIGO CO TENNESSEE INC
ERYTHROMYCIN~OINTMENT;OPHTHALMIC~ERYTHROMYCIN~PHARMADERM~5MG/GM~A~062446~001~~Se
p 26, 1983~No~DISCN~PHARMADERM DIV ALTANA INC
ERYTHROMYCIN~OINTMENT;OPHTHALMIC~ERYTHROMYCIN~PHARMAFAIR~5MG/GM~A~062481~001~~Ap
r 5, 1984~No~DISCN~PHARMAFAIR INC
ISOFLUROPHATE~OINTMENT;OPHTHALMIC~FLOROPRYL~MERCK~0.025%~N~010656~001~~Approved
Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
FLUOROMETHOLONE~OINTMENT;OPHTHALMIC~FML~ALLERGAN~0.1%~N~017760~001~~Sep 4, 1985~
Yes~RX~ALLERGAN PHARMACEUTICAL
SULFISOXAZOLE DIOLAMINE~OINTMENT;OPHTHALMIC~GANTRISIN~ROCHE~EQ 4% BASE~N~008414~
002~~Approved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
GENTAMICIN SULFATE~OINTMENT;OPHTHALMIC~GARAMYCIN~SCHERING~EQ 0.3% BASE~N~050425~
001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CO
RP
GENTAMICIN SULFATE~OINTMENT;OPHTHALMIC~GENTACIDIN~NOVARTIS~EQ 0.3% BASE~A~062501
~001~~Jul 26, 1984~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
GENTAMICIN SULFATE~OINTMENT;OPHTHALMIC~GENTAFAIR~PHARMAFAIR~EQ 3MG BASE/GM~A~062
443~001~~May 26, 1983~No~DISCN~PHARMAFAIR INC
GENTAMICIN SULFATE~OINTMENT;OPHTHALMIC~GENTAMICIN SULFATE~AKORN~EQ 0.3% BASE~A~0
64093~001~AT~Aug 31, 1995~Yes~RX~AKORN INC
GENTAMICIN SULFATE~OINTMENT;OPHTHALMIC~GENTAMICIN SULFATE~PERRIGO CO TENNESSEE~E
Q 0.3% BASE~A~065024~001~AT~Jul 30, 2004~No~RX~PERRIGO CO TENNESSEE INC
HYDROCORTISONE ACETATE~OINTMENT;OPHTHALMIC~HYDROCORTISONE ACETATE~FERA PHARMS~0.
5%~A~080828~001~~Approved Prior to Jan 1, 1982~No~DISCN~FERA PHARMACEUTICALS LLC
ERYTHROMYCIN~OINTMENT;OPHTHALMIC~ILOTYCIN~DISTA~0.5%~N~050368~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO DIV ELI LILLY AND CO
LOTEPREDNOL ETABONATE~OINTMENT;OPHTHALMIC~LOTEMAX~BAUSCH AND LOMB~0.5%~N~200738~
001~~Apr 15, 2011~Yes~RX~BAUSCH AND LOMB INC
DEXAMETHASONE SODIUM PHOSPHATE~OINTMENT;OPHTHALMIC~MAXIDEX~ALCON~EQ 0.05% PHOSPH
ATE~A~083342~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~MAXITRO
L~FALCON PHARMS~0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~N~050065~002~AT~Approved P
rior to Jan 1, 1982~Yes~RX~FALCON PHARMACEUTICALS LTD
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~METIMYD~SCHERING~
0.5%;10%~N~010210~002~~Sep 9, 1984~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CO
RP
BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~MYCITRACIN
~PHARMACIA AND UPJOHN~500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~061048~001
~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE~OINTMENT;OPHTHALMIC~NEO-CORTEF~PHARMACI
A AND UPJOHN~0.5%;EQ 3.5MG BASE/GM~A~060610~001~~Approved Prior to Jan 1, 1982~N
o~DISCN~PHARMACIA AND UPJOHN CO
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE~OINTMENT;OPHTHALMIC~NEO-CORTEF~PHARMACI
A AND UPJOHN~1.5%;EQ 3.5MG BASE/GM~A~060610~002~~Approved Prior to Jan 1, 1982~N
o~DISCN~PHARMACIA AND UPJOHN CO
NEOMYCIN SULFATE; PREDNISOLONE ACETATE~OINTMENT;OPHTHALMIC~NEO-DELTA-CORTEF~PHAR
MACIA AND UPJOHN~EQ 3.5MG BASE/GM;0.25%~A~061039~002~~Approved Prior to Jan 1, 1
NEOMYCIN SULFATE; PREDNISOLONE ACETATE~OINTMENT;OPHTHALMIC~NEO-DELTA-CORTEF~PHAR
MACIA AND UPJOHN~EQ 3.5MG BASE/GM;0.5%~A~061039~001~~Approved Prior to Jan 1, 19
NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE~OINTMENT;OPHTHALMIC~NEO-HYDELTRA
SOL~MERCK~EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE~N~050378~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~MERCK AND CO INC
METHYLPREDNISOLONE; NEOMYCIN SULFATE~OINTMENT;OPHTHALMIC~NEO-MEDROL~PHARMACIA AN
D UPJOHN~0.1%;EQ 3.5MG BASE/GM~A~060645~001~~Approved Prior to Jan 1, 1982~No~DI
SCN~PHARMACIA AND UPJOHN CO
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~NEO-P
OLYCIN~DOW PHARM~500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~060647~001~~App
roved Prior to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL CORP SUB DOW CHEMICAL CO

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE~OINTMENT;OPHTHALMIC~NEODECADRON
~MERCK~EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM~N~050324~001~~Approved Prior to Jan 1
, 1982~No~DISCN~MERCK AND CO INC
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~NEOMY
CIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC~AKORN~400 UNITS/GM;EQ 3.5MG BAS
E/GM;10,000 UNITS/GM~A~065088~001~AT~Feb 6, 2004~No~RX~AKORN INC
CIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC~BAUSCH AND LOMB~400 UNITS/GM;EQ
3.5MG BASE/GM;10,000 UNITS/GM~A~064064~001~AT~Oct 30, 1995~Yes~RX~BAUSCH AND LO
MB PHARMACEUTICALS INC
CIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC~PERRIGO CO TENNESSEE~400 UNITS/
GM;EQ 3.5MG BASE;10,000 UNITS/GM~A~060764~002~AT~Approved Prior to Jan 1, 1982~N
o~RX~PERRIGO CO TENNESSEE INC
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~NEOMYCI
N AND POLYMYXIN B SULFATES AND DEXAMETHASONE~BAUSCH AND LOMB~0.1%;EQ 3.5MG BASE/
GM;10,000 UNITS/GM~A~064063~001~AT~Jul 25, 1994~No~RX~BAUSCH AND LOMB PHARMACEUT
ICALS INC
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~NEOMYCI
N AND POLYMYXIN B SULFATES AND DEXAMETHASONE~PERRIGO CO TENNESSEE~0.1%;EQ 3.5MG
BASE/GM;10,000 UNITS/GM~A~062938~001~AT~Jul 31, 1989~No~RX~PERRIGO CO TENNESSEE
INC
OPHTHALMIC~NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
~AKORN~400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~065213~001~AT~Jul 25,
OPHTHALMIC~NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
~BAUSCH AND LOMB~400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~064068~001~A
T~Oct 30, 1995~Yes~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~NEOSP
ORIN~CITRON PHARMA LLC~400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM~N~050417~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~CITRON PHARMA LLC
BACITRACIN ZINC; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~OCUMYCIN~PHARMAFAIR~500
UNITS/GM;10,000 UNITS/GM~A~062430~001~~Apr 8, 1983~No~DISCN~PHARMAFAIR INC
CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC
~OPHTHOCORT~PARKEDALE~10MG/GM;5MG/GM;10,000 UNITS/GM~N~050201~002~~Approved Prio
r to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
BACITRACIN ZINC; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~POLYSPORIN~MONARCH PHAR
MS~500 UNITS/GM;10,000 UNITS/GM~A~061229~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~MONARCH PHARMACEUTICALS INC
GENTAMICIN SULFATE; PREDNISOLONE ACETATE~OINTMENT;OPHTHALMIC~PRED-G~ALLERGAN~EQ
0.3% BASE;0.6%~N~050612~001~~Dec 1, 1989~Yes~RX~ALLERGAN PHARMACEUTICAL
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~PREDSULFAIR~PHARM
AFAIR~0.5%;10%~A~088032~001~~Apr 15, 1983~No~DISCN~PHARMAFAIR INC
SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~SODIUM SULAMYD~SCHERING~10%~N~005963~00
NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~STATROL~ALCON~EQ 3.5MG
BASE/GM;10,000 UNITS/GM~N~050344~002~~Approved Prior to Jan 1, 1982~No~DISCN~AL
CON LABORATORIES INC
IDOXURIDINE~OINTMENT;OPHTHALMIC~STOXIL~GLAXOSMITHKLINE~0.5%~N~015868~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~SULFACETAMIDE SODIUM~PERRIGO CO TENNESS
EE~10%~A~080029~001~AT~Approved Prior to Jan 1, 1982~No~RX~PERRIGO CO TENNESSEE
INC
SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~SULFAIR 10~PHARMAFAIR~10%~A~088000~001~
~Dec 22, 1982~No~DISCN~PHARMAFAIR INC
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE~OINTMENT;OPHTHALMIC~TERRAMYCI
N W/ POLYMYXIN B SULFATE~PFIZER~EQ 5MG BASE/GM;10,000 UNITS/GM~A~061015~001~~App
roved Prior to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC

DEXAMETHASONE; TOBRAMYCIN~OINTMENT;OPHTHALMIC~TOBRADEX~ALCON~0.1%;0.3%~N~050616~
001~~Sep 28, 1988~Yes~RX~ALCON LABORATORIES INC
TOBRAMYCIN~OINTMENT;OPHTHALMIC~TOBREX~ALCON~0.3%~N~050555~001~~Approved Prior to
Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~OINTMENT;OPHTHALMIC~VASOCIDIN~NOVARTI
S~0.5%;10%~A~088791~001~~Oct 5, 1984~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
VIDARABINE~OINTMENT;OPHTHALMIC~VIRA-A~PARKEDALE~3%~N~050486~001~~Approved Prior
to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
OPHTHALMIC~ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE
~PHARMAFAIR~400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM~A~062389~001~~Jul 2
, 1982~No~DISCN~PHARMAFAIR INC
PREDNISOLONE SODIUM PHOSPHATE~OINTMENT;OPHTHALMIC, OTIC~HYDELTRASOL~MERCK~EQ 0.2
5% PHOSPHATE~N~011028~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO I
NC
HYDROCORTISONE ACETATE~OINTMENT;OPHTHALMIC, OTIC~HYDROCORTONE~MERCK~1.5%~N~00901
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE~OINTMENT;OTIC~TERRAMYCIN W/ P
OLYMYXIN~PFIZER~EQ 5MG BASE/GM;10,000 UNITS/GM~A~061841~001~~Approved Prior to J
an 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
ALCLOMETASONE DIPROPIONATE~OINTMENT;TOPICAL~ACLOVATE~FOUGERA PHARMS~0.05%~N~0187
02~001~~Dec 14, 1982~No~DISCN~FOUGERA PHARMACEUTICALS INC
ACYCLOVIR~OINTMENT;TOPICAL~ACYCLOVIR~AMNEAL PHARMS~5%~A~204605~001~AB~Jun 18, 20
14~No~RX~AMNEAL PHARMACEUTICALS
ACYCLOVIR~OINTMENT;TOPICAL~ACYCLOVIR~MYLAN PHARMS INC~5%~A~202459~001~AB~Apr 3,
ERYTHROMYCIN~OINTMENT;TOPICAL~AKNE-MYCIN~DOW PHARM~2%~N~050584~001~~Jan 10, 1985
~Yes~RX~DOW PHARMACEUTICAL SCIENCES
ALCLOMETASONE DIPROPIONATE~OINTMENT;TOPICAL~ALCLOMETASONE DIPROPIONATE~FOUGERA P
HARMS~0.05%~A~076884~001~AB~Jul 18, 2005~Yes~RX~FOUGERA PHARMACEUTICALS INC
ALCLOMETASONE DIPROPIONATE~OINTMENT;TOPICAL~ALCLOMETASONE DIPROPIONATE~GLENMARK
GENERICS~0.05%~A~079227~001~AB~Jul 30, 2009~No~RX~GLENMARK GENERICS LTD
ALCLOMETASONE DIPROPIONATE~OINTMENT;TOPICAL~ALCLOMETASONE DIPROPIONATE~TARO~0.05
%~A~076730~001~AB~Jul 29, 2004~No~RX~TARO PHARMACEUTICALS USA INC
LIDOCAINE~OINTMENT;TOPICAL~ALPHACAINE~CARLISLE~5%~A~084944~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~CARLISLE LABORATORIES INC
BETAMETHASONE DIPROPIONATE~OINTMENT;TOPICAL~ALPHATREX~SAVAGE LABS~EQ 0.05% BASE~
N~019143~001~~Sep 4, 1984~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
RETAPAMULIN~OINTMENT;TOPICAL~ALTABAX~GLAXO GRP LTD~1%~N~022055~001~~Apr 12, 2007
~Yes~RX~GLAXO GROUP LTD DBA GLAXOSMITHKLINE
AMCINONIDE~OINTMENT;TOPICAL~AMCINONIDE~FOUGERA PHARMS~0.1%~A~076096~001~AB~Nov 1
AMCINONIDE~OINTMENT;TOPICAL~AMCINONIDE~TARO PHARM INDS~0.1%~A~076367~001~AB~Mar
19, 2003~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~ARISTOCORT~ASTELLAS~0.1%~A~080750~004~~
Approved Prior to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~ARISTOCORT~ASTELLAS~0.5%~A~080745~002~~
Approved Prior to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~ARISTOCORT A~ASTELLAS~0.1%~A~080750~003
~~Approved Prior to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
~~Oct 1, 1984~No~DISCN~ASTELLAS PHARMA US INC
~~Approved Prior to Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
~~Oct 5, 1984~No~DISCN~ASTELLAS PHARMA US INC

BACITRACIN~OINTMENT;TOPICAL~BACITRACIN~COMBE~500 UNITS/GM~A~062799~001~~May 14,
1987~No~DISCN~COMBE INC
BACITRACIN~OINTMENT;TOPICAL~BACITRACIN~NASKA~500 UNITS/GM~A~062857~001~~Nov 13,
1987~No~DISCN~NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;TOPICAL~BACITRAC
IN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE~NASKA~400 UNITS/GM;EQ 3.5MG BASE/GM
;5,000 UNITS/GM~A~062833~001~~Nov 9, 1987~No~DISCN~NASKA PHARMACAL CO INC DIV RU
GBY DARBY GROUP COSMETICS
BACITRACIN ZINC; POLYMYXIN B SULFATE~OINTMENT;TOPICAL~BACITRACIN ZINC-POLYMYXIN
B SULFATE~NASKA~500 UNITS/GM;10,000 UNITS/GM~A~062849~001~~Nov 13, 1987~No~DISCN
~NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS
MUPIROCIN~OINTMENT;TOPICAL~BACTROBAN~GLAXOSMITHKLINE~2%~N~050591~001~AB~Dec 31,
BETAMETHASONE VALERATE~OINTMENT;TOPICAL~BETA-VAL~TEVA~EQ 0.1% BASE~A~070069~001~
~Dec 19, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
BETAMETHASONE DIPROPIONATE~OINTMENT;TOPICAL~BETAMETHASONE DIPROPIONATE~ACTAVIS M
ID ATLANTIC~EQ 0.05% BASE~A~071012~001~AB~Feb 3, 1987~No~RX~ACTAVIS MID ATLANTIC
LLC
BETAMETHASONE DIPROPIONATE~OINTMENT;TOPICAL~BETAMETHASONE DIPROPIONATE~FOUGERA~E
Q 0.05% BASE~N~019141~001~AB~Sep 4, 1984~Yes~RX~E FOUGERA DIV ALTANA INC
BETAMETHASONE DIPROPIONATE~OINTMENT;TOPICAL~BETAMETHASONE DIPROPIONATE~PERRIGO N
EW YORK~EQ 0.05% BASE~A~072526~001~~Jan 31, 1990~No~DISCN~PERRIGO NEW YORK INC
BETAMETHASONE DIPROPIONATE~OINTMENT;TOPICAL~BETAMETHASONE DIPROPIONATE~PHARMADER
M~EQ 0.05% BASE~N~019140~001~~Sep 4, 1984~No~DISCN~PHARMADERM DIV ALTANA INC
BETAMETHASONE DIPROPIONATE~OINTMENT;TOPICAL~BETAMETHASONE DIPROPIONATE~TARO~EQ 0
.05% BASE~A~074271~001~AB~Sep 15, 1994~No~RX~TARO PHARMACEUTICALS INC
BETAMETHASONE DIPROPIONATE~OINTMENT;TOPICAL~BETAMETHASONE DIPROPIONATE~TEVA~EQ 0
.05% BASE~A~071477~001~~Aug 10, 1987~No~DISCN~TEVA PHARMACEUTICALS USA INC
BETAMETHASONE VALERATE~OINTMENT;TOPICAL~BETAMETHASONE VALERATE~ACTAVIS MID ATLAN
TIC~EQ 0.1% BASE~A~070051~001~AB~Oct 10, 1984~No~RX~ACTAVIS MID ATLANTIC LLC
BETAMETHASONE VALERATE~OINTMENT;TOPICAL~BETAMETHASONE VALERATE~FOUGERA~EQ 0.1% B
ASE~N~018865~001~AB~Aug 31, 1983~Yes~RX~E FOUGERA DIV ALTANA INC
BETAMETHASONE VALERATE~OINTMENT;TOPICAL~BETAMETHASONE VALERATE~PERRIGO NEW YORK~
EQ 0.1% BASE~A~071478~001~~Dec 23, 1987~No~DISCN~PERRIGO NEW YORK INC
BETAMETHASONE VALERATE~OINTMENT;TOPICAL~BETAMETHASONE VALERATE~PHARMADERM~EQ 0.1
% BASE~N~018864~001~~Aug 31, 1983~No~DISCN~PHARMADERM DIV ALTANA INC
BETAMETHASONE VALERATE~OINTMENT;TOPICAL~BETAMETHASONE VALERATE~PHARMAFAIR~EQ 0.1
% BASE~A~070486~001~~May 29, 1987~No~DISCN~PHARMAFAIR INC
BETAMETHASONE VALERATE~OINTMENT;TOPICAL~BETATREX~SAVAGE LABS~EQ 0.1% BASE~N~0188
63~001~~Aug 31, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
CALCIPOTRIENE~OINTMENT;TOPICAL~CALCIPOTRIENE~GLENMARK GENERICS~0.005%~A~090633~0
01~~Mar 24, 2010~Yes~RX~GLENMARK GENERICS INC USA
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE~OINTMENT;TOPICAL~CALCIPOTRIENE
AND BETAMETHASONE DIPROPIONATE~PERRIGO ISRAEL~0.064%;0.005%~A~200174~001~AB~Dec
12, 2014~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE~OINTMENT;TOPICAL~CALCIPOTRIENE
AND BETAMETHASONE DIPROPIONATE~TOLMAR~0.064%;0.005%~A~201615~001~AB~Jan 14, 201
3~No~RX~TOLMAR INC
MUPIROCIN~OINTMENT;TOPICAL~CENTANY~PERRIGO NEW YORK~2%~N~050788~001~BX~Dec 4, 20
CLOBETASOL PROPIONATE~OINTMENT;TOPICAL~CLOBETASOL PROPIONATE~ACTAVIS MID ATLANTI
C~0.05%~A~074128~001~~Aug 3, 1994~No~DISCN~ACTAVIS MID ATLANTIC LLC
CLOBETASOL PROPIONATE~OINTMENT;TOPICAL~CLOBETASOL PROPIONATE~FOUGERA PHARMS~0.05
%~A~074407~001~AB~Feb 23, 1996~No~RX~FOUGERA PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~OINTMENT;TOPICAL~CLOBETASOL PROPIONATE~G AND W LABS INC~0.
05%~A~074089~001~AB~Feb 16, 1994~No~RX~G AND W LABORATORIES INC
CLOBETASOL PROPIONATE~OINTMENT;TOPICAL~CLOBETASOL PROPIONATE~RENAISSANCE PHARMA~
0.05%~A~075057~001~~Aug 12, 1998~No~DISCN~RENAISSANCE PHARMA US HOLDINGS INC
CLOBETASOL PROPIONATE~OINTMENT;TOPICAL~CLOBETASOL PROPIONATE~TARO~0.05%~A~074248
~001~AB~Jul 12, 1996~No~RX~TARO PHARMACEUTICALS INC

FLURANDRENOLIDE~OINTMENT;TOPICAL~CORDRAN~AQUA PHARMS~0.025% **Federal Register d
cy reasons**~N~012806~004~~Approved Prior to Jan 1, 1982~No~DISCN~AQUA PHARMACEU
TICALS
FLURANDRENOLIDE~OINTMENT;TOPICAL~CORDRAN~AQUA PHARMS~0.05% **Federal Register de
y reasons**~N~012806~001~~Approved Prior to Jan 1, 1982~No~DISCN~AQUA PHARMACEUT
ICALS
FLURANDRENOLIDE; NEOMYCIN SULFATE~OINTMENT;TOPICAL~CORDRAN-N~LILLY~0.05%;EQ 3.5M
G BASE/GM~N~050345~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
HYDROCORTISONE ACETATE~OINTMENT;TOPICAL~CORTEF ACETATE~PHARMACIA AND UPJOHN~1%~N
~008917~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
HYDROCORTISONE ACETATE~OINTMENT;TOPICAL~CORTEF ACETATE~PHARMACIA AND UPJOHN~2.5%
for safety or efficacy reasons**~N~008917~001~~Approved Prior to Jan 1, 1982~No
~DISCN~PHARMACIA AND UPJOHN CO
TOPICAL~CORTISPORIN~MONARCH PHARMS~400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/
GM~N~050168~002~~May 4, 1984~Yes~RX~MONARCH PHARMACEUTICALS INC
HYDROCORTISONE~OINTMENT;TOPICAL~CORTRIL~PFIZER GLOBAL~1%~N~009176~001~~Approved
Prior to Jan 1, 1982~No~DISCN~PFIZER GLOBAL RESEARCH DEVELOPMENT
HYDROCORTISONE~OINTMENT;TOPICAL~CORTRIL~PFIZER GLOBAL~2.5%~N~009176~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~PFIZER GLOBAL RESEARCH DEVELOPMENT
FLUTICASONE PROPIONATE~OINTMENT;TOPICAL~CUTIVATE~FOUGERA PHARMS~0.005%~N~019957~
001~AB~Dec 14, 1990~Yes~RX~FOUGERA PHARMACEUTICALS INC
AMCINONIDE~OINTMENT;TOPICAL~CYCLOCORT~ASTELLAS~0.1%~N~018498~001~~Approved Prior
PREDNICARBATE~OINTMENT;TOPICAL~DERMATOP~VALEANT BERMUDA~0.1%~N~019568~001~AB~Sep
23, 1991~Yes~RX~VALEANT INTERNATIONAL BERMUDA
DESONIDE~OINTMENT;TOPICAL~DESONIDE~FOUGERA PHARMS~0.05%~A~075751~001~AB~Mar 12,
DESONIDE~OINTMENT;TOPICAL~DESONIDE~PERRIGO NEW YORK~0.05%~N~017426~001~AB~Approv
ed Prior to Jan 1, 1982~Yes~RX~PERRIGO NEW YORK INC
DESONIDE~OINTMENT;TOPICAL~DESONIDE~TARO~0.05%~A~074254~001~AB~Aug 3, 1994~No~RX~
TARO PHARMACEUTICALS USA INC
DESONIDE~OINTMENT;TOPICAL~DESOWEN~GALDERMA LABS LP~0.05%~A~071425~001~AB~Jun 15,
1988~No~RX~GALDERMA LABORATORIES LP
DESOXIMETASONE~OINTMENT;TOPICAL~DESOXIMETASONE~ALTANA~0.25%~A~073440~001~~Apr 1,
1998~No~DISCN~ALTANA INC
DESOXIMETASONE~OINTMENT;TOPICAL~DESOXIMETASONE~FOUGERA PHARMS~0.25%~A~078657~001
~AB~Sep 28, 2012~No~RX~FOUGERA PHARMACEUTICALS INC
DESOXIMETASONE~OINTMENT;TOPICAL~DESOXIMETASONE~GLENMARK GENERICS~0.25%~A~202838~
001~AB~Sep 20, 2013~No~RX~GLENMARK GENERICS LTD
DESOXIMETASONE~OINTMENT;TOPICAL~DESOXIMETASONE~VERSAPHARM INC~0.25%~A~201005~001
~AB~Apr 24, 2014~No~RX~VERSAPHARM INC
DIFLORASONE DIACETATE~OINTMENT;TOPICAL~DIFLORASONE DIACETATE~FOUGERA PHARMS~0.05
%~A~075374~001~AB~Apr 27, 1999~No~RX~FOUGERA PHARMACEUTICALS INC
DIFLORASONE DIACETATE~OINTMENT;TOPICAL~DIFLORASONE DIACETATE~TARO~0.05%~A~075331
~001~AB~May 14, 1999~Yes~RX~TARO PHARMACEUTICALS INC
BETAMETHASONE DIPROPIONATE~OINTMENT;TOPICAL~DIPROSONE~SCHERING~EQ 0.05% BASE~N~0
17691~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLO
UGH CORP
CALCIPOTRIENE~OINTMENT;TOPICAL~DOVONEX~LEO PHARMA AS~0.005%~N~020273~001~~Dec 29
, 1993~No~DISCN~LEO PHARMA AS
CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN~OINTMENT;TOPICAL~ELASE-CHLOROM
YCETIN~PARKE DAVIS~10MG/GM;666 UNITS/GM;1 UNITS/GM~N~050294~001~~Approved Prior
to Jan 1, 1982~No~DISCN~PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT C
O
MOMETASONE FUROATE~OINTMENT;TOPICAL~ELOCON~MERCK SHARP DOHME~0.1%~N~019543~001~A
B~Apr 30, 1987~Yes~RX~MERCK SHARP AND DOHME CORP

CLOBETASOL PROPIONATE~OINTMENT;TOPICAL~EMBELINE~HI TECH PHARMA~0.05%~A~074221~00
1~AB~Mar 31, 1995~No~RX~HI TECH PHARMACAL CO INC
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUOCINOLONE ACETONIDE~FOUGERA~0.025%~A~
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUOCINOLONE ACETONIDE~G AND W LABS~0.02
5%~A~089524~001~AT~Jul 26, 1988~No~RX~G AND W LABORATORIES INC
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUOCINOLONE ACETONIDE~PHARMADERM~0.025%
~A~088046~001~~Dec 16, 1982~No~DISCN~PHARMADERM DIV ALTANA INC
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUOCINOLONE ACETONIDE~PHARMAFAIR~0.025%
~A~088507~001~~Feb 27, 1984~No~DISCN~PHARMAFAIR INC
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUOCINOLONE ACETONIDE~TARO~0.025%~A~040
041~001~AT~Sep 15, 1994~No~RX~TARO PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUOCINOLONE ACETONIDE~USL PHARMA~0.025%
~A~088742~001~~Feb 8, 1985~No~DISCN~USL PHARMA INC
FLUOCINONIDE~OINTMENT;TOPICAL~FLUOCINONIDE~FOUGERA PHARMS~0.05%~A~074905~001~AB~
Aug 26, 1997~No~RX~FOUGERA PHARMACEUTICALS INC
FLUOCINONIDE~OINTMENT;TOPICAL~FLUOCINONIDE~TARO~0.05%~A~075008~001~AB~Jun 30, 19
99~Yes~RX~TARO PHARMACEUTICALS INC
FLUOCINONIDE~OINTMENT;TOPICAL~FLUOCINONIDE~TEVA~0.05%~A~073481~001~AB~Dec 27, 19
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUONID~ALLERGAN HERBERT~0.025%~A~087157
~001~~Sep 6, 1984~No~DISCN~ALLERGAN HERBERT DIV ALLERGAN INC
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUOTREX~SAVAGE LABS~0.025%~A~088172~001
~~Mar 9, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUTEX~IVAX PHARMS~0.025%~A~087375~001~
~Nov 1, 1988~No~DISCN~IVAX PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUTEX~IVAX PHARMS~0.1%~A~087377~001~~N
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~FLUTEX~IVAX PHARMS~0.5%~A~087376~001~~N
FLUTICASONE PROPIONATE~OINTMENT;TOPICAL~FLUTICASONE PROPIONATE~FOUGERA PHARMS~0.
005%~A~076300~001~AB~May 14, 2004~No~RX~FOUGERA PHARMACEUTICALS INC
FLUTICASONE PROPIONATE~OINTMENT;TOPICAL~FLUTICASONE PROPIONATE~G AND W LABS~0.00
5%~A~077168~001~AB~Mar 3, 2006~No~RX~G AND W LABORATORIES INC
FLUTICASONE PROPIONATE~OINTMENT;TOPICAL~FLUTICASONE PROPIONATE~PERRIGO NEW YORK~
0.005%~A~076668~001~AB~May 14, 2004~No~RX~PERRIGO NEW YORK INC
FLUTICASONE PROPIONATE~OINTMENT;TOPICAL~FLUTICASONE PROPIONATE~TARO PHARM INDS~0
.005%~A~077145~001~~Jun 14, 2005~No~DISCN~TARO PHARMACEUTICAL INDUSTRIES LTD
AMPHOTERICIN B~OINTMENT;TOPICAL~FUNGIZONE~APOTHECON~3%~N~050313~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
NITROFURAZONE~OINTMENT;TOPICAL~FURACIN~SHIRE~0.2%~N~005795~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
GENTAMICIN SULFATE~OINTMENT;TOPICAL~GARAMYCIN~SCHERING~EQ 0.1% BASE~A~060463~001
GENTAMICIN SULFATE~OINTMENT;TOPICAL~GENTAFAIR~PHARMAFAIR~EQ 0.1% BASE~A~062444~0
01~~May 26, 1983~No~DISCN~PHARMAFAIR INC
GENTAMICIN SULFATE~OINTMENT;TOPICAL~GENTAMICIN SULFATE~ALPHARMA US PHARMS~EQ 0.1
% BASE~A~062496~001~~Mar 14, 1984~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
GENTAMICIN SULFATE~OINTMENT;TOPICAL~GENTAMICIN SULFATE~FOUGERA~EQ 0.1% BASE~A~06
2533~001~AT~Oct 5, 1984~No~RX~E FOUGERA DIV ALTANA INC
GENTAMICIN SULFATE~OINTMENT;TOPICAL~GENTAMICIN SULFATE~G AND W LABS INC~EQ 0.1%
BASE~A~064054~001~~Apr 29, 1994~No~DISCN~G AND W LABORATORIES INC
GENTAMICIN SULFATE~OINTMENT;TOPICAL~GENTAMICIN SULFATE~PERRIGO NEW YORK~EQ 0.1%
BASE~A~062351~001~AT~Feb 18, 1982~Yes~RX~PERRIGO NEW YORK INC
GENTAMICIN SULFATE~OINTMENT;TOPICAL~GENTAMICIN SULFATE~PHARMADERM~EQ 0.1% BASE~A
~062534~001~~Oct 10, 1984~No~DISCN~PHARMADERM DIV ALTANA INC
GENTAMICIN SULFATE~OINTMENT;TOPICAL~GENTAMICIN SULFATE~TARO~EQ 0.1% BASE~A~06247
7~001~AT~Dec 23, 1983~No~RX~TARO PHARMACEUTICALS USA INC
HALOBETASOL PROPIONATE~OINTMENT;TOPICAL~HALOBETASOL PROPIONATE~FOUGERA PHARMS~0.
05%~A~076903~001~~Dec 16, 2004~No~DISCN~FOUGERA PHARMACEUTICALS INC

HALOBETASOL PROPIONATE~OINTMENT;TOPICAL~HALOBETASOL PROPIONATE~G AND W LABS~0.05
%~A~077721~001~AB~Sep 7, 2006~No~RX~G AND W LABORATORIES INC
HALOBETASOL PROPIONATE~OINTMENT;TOPICAL~HALOBETASOL PROPIONATE~G AND W LABS INC~
0.05%~A~077109~001~~Jun 14, 2005~No~DISCN~G AND W LABORATORIES INC
HALOBETASOL PROPIONATE~OINTMENT;TOPICAL~HALOBETASOL PROPIONATE~PERRIGO~0.05%~A~0
76872~001~AB~Dec 16, 2004~No~RX~PERRIGO CO
HALOBETASOL PROPIONATE~OINTMENT;TOPICAL~HALOBETASOL PROPIONATE~TARO~0.05%~A~0769
94~001~AB~Dec 16, 2004~No~RX~TARO PHARMACEUTICALS USA INC
HALCINONIDE~OINTMENT;TOPICAL~HALOG~BRISTOL MYERS SQUIBB~0.025%~N~018125~001~~App
roved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
HALCINONIDE~OINTMENT;TOPICAL~HALOG~RANBAXY~0.1%~N~017824~001~~Approved Prior to
Jan 1, 1982~Yes~RX~RANBAXY LABORATORIES INC
HYDROCORTISONE~OINTMENT;TOPICAL~HC (HYDROCORTISONE)~C AND M PHARMA~0.5%~A~080481
~001~~Approved Prior to Jan 1, 1982~No~DISCN~C AND M PHARMACAL INC
HYDROCORTISONE~OINTMENT;TOPICAL~HC (HYDROCORTISONE)~C AND M PHARMA~1%~A~080481~0
02~~Approved Prior to Jan 1, 1982~No~DISCN~C AND M PHARMACAL INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~ACTAVIS MID ATLANTIC~1%~A~087796~
001~AT~Oct 13, 1982~No~RX~ACTAVIS MID ATLANTIC LLC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~ALTANA~0.5%~A~080489~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~ALTANA INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~ALTANA~1%~A~080489~003~~Approved
Prior to Jan 1, 1982~No~DISCN~ALTANA INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~AMBIX~1%~A~086079~001~~Approved P
rior to Jan 1, 1982~No~DISCN~AMBIX LABORATORIES DIV ORGANICS CORP AMERICA
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~AMBIX~2.5%~A~086272~001~~Approved
Prior to Jan 1, 1982~No~DISCN~AMBIX LABORATORIES DIV ORGANICS CORP AMERICA
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~FOUGERA~2.5%~A~081203~001~AT~May
28, 1993~Yes~RX~E FOUGERA DIV ALTANA INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~FOUGERA PHARMS~1%~A~080692~001~AT
~Approved Prior to Jan 1, 1982~Yes~RX~FOUGERA PHARMACEUTICALS INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~NASKA~1%~A~089704~001~~Mar 10, 19
88~No~DISCN~NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~PERRIGO NEW YORK~0.5%~A~084969~00
3~~Approved Prior to Jan 1, 1982~No~DISCN~PERRIGO NEW YORK INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~PERRIGO NEW YORK~1%~A~085028~001~
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~PERRIGO NEW YORK~2.5%~A~085027~00
1~AT~Approved Prior to Jan 1, 1982~No~RX~PERRIGO NEW YORK INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~PHARMADERM~1%~A~088842~001~~Feb 9
, 1987~No~DISCN~PHARMADERM DIV ALTANA INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~TARO~0.5%~A~086256~001~~Approved
Prior to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~TARO~1%~A~086257~001~AT~Approved
Prior to Jan 1, 1982~No~RX~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~TARO~2.5%~A~040310~001~~Dec 29, 2
000~No~DISCN~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~USL PHARMA~1%~A~088061~001~~Sep 2
7, 1983~No~DISCN~USL PHARMA INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE~USL PHARMA~2.5%~A~088039~001~~Sep
HYDROCORTISONE BUTYRATE~OINTMENT;TOPICAL~HYDROCORTISONE BUTYRATE~TARO~0.1%~A~076
HYDROCORTISONE~OINTMENT;TOPICAL~HYDROCORTISONE IN ABSORBASE~CAROLINA MEDCL~1%~A~
088138~001~AT~Sep 6, 1985~No~RX~CAROLINA MEDICAL PRODUCTS CO
HYDROCORTISONE VALERATE~OINTMENT;TOPICAL~HYDROCORTISONE VALERATE~FOUGERA PHARMS~
0.2%~A~075085~001~~Jul 31, 2001~No~DISCN~FOUGERA PHARMACEUTICALS INC
HYDROCORTISONE VALERATE~OINTMENT;TOPICAL~HYDROCORTISONE VALERATE~TARO~0.2%~A~075
043~001~~Aug 25, 1998~Yes~RX~TARO PHARMACEUTICALS INC
HYDROCORTISONE~OINTMENT;TOPICAL~HYTONE~DERMIK LABS~1%~A~080474~003~~Approved Pri
or to Jan 1, 1982~No~DISCN~DERMIK LABORATORIES DIV AVENTIS PHARMACEUTICALS INC

HYDROCORTISONE~OINTMENT;TOPICAL~HYTONE~DERMIK LABS~2.5%~A~080474~004~~Approved P
rior to Jan 1, 1982~No~DISCN~DERMIK LABORATORIES DIV AVENTIS PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~KENALOG~DELCOR ASSET CORP~0.025%~N~0116
00~003~~Approved Prior to Jan 1, 1982~No~DISCN~DELCOR ASSET CORP
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~KENALOG~DELCOR ASSET CORP~0.1%~N~011600
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~KENALOG~DELCOR ASSET CORP~0.5%~A~083944
BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~OINTMENT;TOPIC
AL~LANABIOTIC~COMBE~400 UNITS/GM;40MG/GM;EQ 5MG BASE/GM;5,000 UNITS/GM~A~062499~
001~~Jun 3, 1985~No~DISCN~COMBE INC
FLUOCINONIDE~OINTMENT;TOPICAL~LIDEX~CNTY LINE PHARMS~0.05% **Federal Register de
y reasons**~N~016909~002~~Approved Prior to Jan 1, 1982~No~DISCN~COUNTY LINE PHA
RMACEUTICALS LLC
LIDOCAINE~OINTMENT;TOPICAL~LIDOCAINE~FOUGERA~5%~A~080198~001~AT~Approved Prior t
o Jan 1, 1982~Yes~RX~E FOUGERA DIV ALTANA INC
LIDOCAINE~OINTMENT;TOPICAL~LIDOCAINE~GRAHAM CHEM~5%~A~080210~001~~Approved Prior
to Jan 1, 1982~No~DISCN~GRAHAM CHEMICAL CO
LIDOCAINE~OINTMENT;TOPICAL~LIDOCAINE~NOVOCOL INC~5%~A~040911~001~AT~May 23, 2011
~No~RX~NOVOCOL INC
LIDOCAINE~OINTMENT;TOPICAL~LIDOCAINE~TARO~5%~A~086724~001~AT~Approved Prior to J
an 1, 1982~No~RX~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE BUTYRATE~OINTMENT;TOPICAL~LOCOID~PRECISION DERMAT~0.1%~N~018652~0
01~AB~Oct 29, 1982~Yes~RX~PRECISION DERMATOLOGY INC
HYDROCORTISONE BUTYRATE~OINTMENT;TOPICAL~LOCOID~YAMANOUCHI~0.1%~N~019106~001~~Ju
l 3, 1984~No~DISCN~YAMANOUCHI EUROPE BV
HYDROCORTAMATE HYDROCHLORIDE~OINTMENT;TOPICAL~MAGNACORT~PFIZER~0.5%~N~010554~001
METHYLPREDNISOLONE ACETATE~OINTMENT;TOPICAL~MEDROL ACETATE~PHARMACIA AND UPJOHN~
0.25%~N~012421~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN
CO
METHYLPREDNISOLONE ACETATE~OINTMENT;TOPICAL~MEDROL ACETATE~PHARMACIA AND UPJOHN~
1%~N~012421~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
MOMETASONE FUROATE~OINTMENT;TOPICAL~MOMETASONE FUROATE~FOUGERA PHARMS~0.1%~A~077
061~001~AB~Mar 28, 2005~No~RX~FOUGERA PHARMACEUTICALS INC
MOMETASONE FUROATE~OINTMENT;TOPICAL~MOMETASONE FUROATE~G AND W LABS~0.1%~A~07740
1~001~AB~Jun 20, 2006~No~RX~G AND W LABORATORIES INC
MOMETASONE FUROATE~OINTMENT;TOPICAL~MOMETASONE FUROATE~GLENMARK GENERICS~0.1%~A~
078571~001~AB~May 28, 2008~No~RX~GLENMARK GENERICS INC USA
MOMETASONE FUROATE~OINTMENT;TOPICAL~MOMETASONE FUROATE~PERRIGO NEW YORK~0.1%~A~0
76067~001~AB~Mar 18, 2002~No~RX~PERRIGO NEW YORK INC
MOMETASONE FUROATE~OINTMENT;TOPICAL~MOMETASONE FUROATE~TARO~0.1%~A~076624~001~~D
ec 3, 2004~No~DISCN~TARO PHARMACEUTICALS USA INC
MOMETASONE FUROATE~OINTMENT;TOPICAL~MOMETASONE FUROATE~TOLMAR~0.1%~A~076481~001~
AB~Nov 14, 2003~No~RX~TOLMAR INC
MUPIROCIN~OINTMENT;TOPICAL~MUPIROCIN~FOUGERA PHARMS~2%~A~065192~001~AB~Nov 30, 2
MUPIROCIN~OINTMENT;TOPICAL~MUPIROCIN~GLENMARK PHARMS~2%~A~090480~001~AB~Jun 8, 2
011~No~RX~GLENMARK PHARMACEUTICALS INC USA
MUPIROCIN~OINTMENT;TOPICAL~MUPIROCIN~PERRIGO NEW YORK~2%~A~065123~001~AB~Nov 7,
MUPIROCIN~OINTMENT;TOPICAL~MUPIROCIN~TARO~2%~A~065170~001~AB~Sep 23, 2005~No~RX~
TARO PHARMACEUTICALS USA INC
MUPIROCIN~OINTMENT;TOPICAL~MUPIROCIN~TEVA~2%~A~065085~001~AB~Nov 7, 2003~No~RX~T
NYSTATIN; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~MYCO-TRIACET II~TEVA~100,000
UNITS/GM;0.1%~A~062045~002~~Nov 26, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
NYSTATIN; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~MYCOLOG-II~DELCOR ASSET CORP~
100,000 UNITS/GM;0.1%~A~060572~001~~Jun 28, 1985~No~DISCN~DELCOR ASSET CORP

NYSTATIN~OINTMENT;TOPICAL~MYCOSTATIN~DELCOR ASSET CORP~100,000 UNITS/GM~A~060571
NYSTATIN; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~MYKACET~G AND W LABS INC~100,
000 UNITS/GM;0.1%~A~062733~001~~Mar 9, 1987~No~DISCN~G AND W LABORATORIES INC
NYSTATIN~OINTMENT;TOPICAL~MYKINAC~ALPHARMA US PHARMS~100,000 UNITS/GM~A~062731~0
01~~Sep 22, 1986~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~MYTREX A~SAVAGE LABS~
EQ 3.5MG BASE/GM;0.1%~A~062609~001~~May 23, 1986~No~DISCN~SAVAGE LABORATORIES IN
C DIV ALTANA INC
NYSTATIN; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~MYTREX F~SAVAGE LABS~100,000
UNITS/GM;0.1%~A~062601~001~~Oct 9, 1985~No~DISCN~SAVAGE LABORATORIES INC DIV ALT
ANA INC
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE~OINTMENT;TOPICAL~NEO-CORTEF~PHARMACIA A
ND UPJOHN~0.5%;EQ 3.5MG BASE/GM~A~060751~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~PHARMACIA AND UPJOHN CO
ND UPJOHN~1%;EQ 3.5MG BASE/GM~A~060751~002~~Approved Prior to Jan 1, 1982~No~DIS
CN~PHARMACIA AND UPJOHN CO
ND UPJOHN~2.5%;EQ 3.5MG BASE/GM~A~060751~003~~Approved Prior to Jan 1, 1982~No~D
ISCN~PHARMACIA AND UPJOHN CO
TOPICAL~NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE~PHARM
AFAIR~400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM~A~062381~001~~Sep 6, 1985~
No~DISCN~PHARMAFAIR INC
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~NEOMYCIN SULFATE-TRIA
MCINOLONE ACETONIDE~FOUGERA~EQ 3.5MG BASE/GM;0.1%~A~062608~001~~May 23, 1986~No~
DISCN~E FOUGERA DIV ALTANA INC
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~NEOMYCIN SULFATE-TRIA
MCINOLONE ACETONIDE~PHARMADERM~EQ 3.5MG BASE/GM;0.1%~A~062607~001~~May 23, 1986~
No~DISCN~PHARMADERM DIV ALTANA INC
NYSTATIN~OINTMENT;TOPICAL~NILSTAT~LEDERLE~100,000 UNITS/GM~A~061444~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
NITROFURAZONE~OINTMENT;TOPICAL~NITROFURAZONE~AMBIX~0.2%~A~086077~001~~Approved P
rior to Jan 1, 1982~No~DISCN~AMBIX LABORATORIES DIV ORGANICS CORP AMERICA
NITROFURAZONE~OINTMENT;TOPICAL~NITROFURAZONE~LANNETT~0.2%~A~084393~001~~Approved
Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
NITROFURAZONE~OINTMENT;TOPICAL~NITROFURAZONE~PERRIGO NEW YORK~0.2%~A~084968~001~
NITROFURAZONE~OINTMENT;TOPICAL~NITROFURAZONE~TARO~0.2%~A~086156~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
NITROFURAZONE~OINTMENT;TOPICAL~NITROFURAZONE~WENDT~0.2%~A~086766~001~~Approved P
rior to Jan 1, 1982~No~DISCN~WENDT LABORATORIES INC
CLIOQUINOL; NYSTATIN~OINTMENT;TOPICAL~NYSTAFORM~BAYER PHARMS~10MG/GM;100,000 UNI
TS/GM~N~050235~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS
CORP
NYSTATIN~OINTMENT;TOPICAL~NYSTATIN~ACTAVIS MID ATLANTIC~100,000 UNITS/GM~A~06284
0~001~AT~Nov 13, 1987~No~RX~ACTAVIS MID ATLANTIC LLC
NYSTATIN~OINTMENT;TOPICAL~NYSTATIN~FOUGERA PHARMS~100,000 UNITS/GM~A~062124~002~
AT~Sep 23, 1982~Yes~RX~FOUGERA PHARMACEUTICALS INC
NYSTATIN~OINTMENT;TOPICAL~NYSTATIN~PERRIGO NEW YORK~100,000 UNITS/GM~A~062472~00
1~AT~Feb 13, 1984~No~RX~PERRIGO NEW YORK INC
NYSTATIN; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~NYSTATIN AND TRIAMCINOLONE AC
ETONIDE~FOUGERA~100,000 UNITS/GM;0.1%~A~062602~001~AT~Oct 9, 1985~No~RX~E FOUGER
A DIV ALTANA INC
ETONIDE~PERRIGO NEW YORK~100,000 UNITS/GM;0.1%~A~062280~002~~Oct 10, 1985~No~DIS
CN~PERRIGO NEW YORK INC
ETONIDE~PHARMAFAIR~100,000 UNITS/GM;0.1%~A~062656~001~~Jul 30, 1986~No~DISCN~PHA

RMAFAIR INC
ETONIDE~TARO~100,000 UNITS/GM;0.1%~A~063305~001~AT~Mar 29, 1993~Yes~RX~TARO PHAR
MACEUTICALS USA INC
NYSTATIN; TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~NYSTATIN-TRIAMCINOLONE ACETON
IDE~PHARMADERM~100,000 UNITS/GM;0.1%~A~062603~001~~Oct 9, 1985~No~DISCN~PHARMADE
RM DIV ALTANA INC
HYDROCORTISONE~OINTMENT;TOPICAL~PENECORT~ALLERGAN HERBERT~2.5%~A~088217~001~~Jun
6, 1984~No~DISCN~ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC
PREDNICARBATE~OINTMENT;TOPICAL~PREDNICARBATE~FOUGERA PHARMS~0.1%~A~077236~001~AB
~Mar 9, 2007~No~RX~FOUGERA PHARMACEUTICALS INC
TACROLIMUS~OINTMENT;TOPICAL~PROTOPIC~ASTELLAS~0.03%~N~050777~001~AB~Dec 8, 2000~
Yes~RX~ASTELLAS PHARMA US INC
TACROLIMUS~OINTMENT;TOPICAL~PROTOPIC~ASTELLAS~0.1%~N~050777~002~AB~Dec 8, 2000~Y
es~RX~ASTELLAS PHARMA US INC
DIFLORASONE DIACETATE~OINTMENT;TOPICAL~PSORCON~PHARMACIA AND UPJOHN~0.05%~N~0192
DIFLORASONE DIACETATE~OINTMENT;TOPICAL~PSORCON E~PHARMACIA AND UPJOHN~0.05%~N~01
FLUOCINOLONE ACETONIDE~OINTMENT;TOPICAL~SYNALAR~MEDIMETRIKS PHARMS~0.025%~N~0139
60~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~MEDIMETRIKS PHARMACEUTICALS INC
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE~OINTMENT;TOPICAL~TACLONEX~LEO
PHARMA AS~0.064%;0.005%~N~021852~001~AB~Jan 9, 2006~Yes~RX~LEO PHARMA AS
TACROLIMUS~OINTMENT;TOPICAL~TACROLIMUS~FOUGERA PHARMS INC~0.03%~A~200744~001~AB~
Sep 9, 2014~No~RX~FOUGERA PHARMACEUTICALS INC
TACROLIMUS~OINTMENT;TOPICAL~TACROLIMUS~FOUGERA PHARMS INC~0.1%~A~200744~002~AB~S
ep 9, 2014~No~RX~FOUGERA PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~OINTMENT;TOPICAL~TEMOVATE~FOUGERA PHARMS~0.05%~N~019323~00
1~AB~Dec 27, 1985~Yes~RX~FOUGERA PHARMACEUTICALS INC
DESOXIMETASONE~OINTMENT;TOPICAL~TOPICORT~TARO~0.25%~A~074286~001~AB~Jun 7, 1996~
Yes~RX~TARO PHARMACEUTICALS INC
DESOXIMETASONE~OINTMENT;TOPICAL~TOPICORT~TARO PHARMS NORTH~0.05%~N~018594~001~~J
an 17, 1985~Yes~RX~TARO PHARMACEUTICALS NORTH AMERICA INC
DESOXIMETASONE~OINTMENT;TOPICAL~TOPICORT~TARO PHARMS NORTH~0.25%~N~018763~001~~S
ep 30, 1983~No~DISCN~TARO PHARMACEUTICALS NORTH AMERICA INC
SUTILAINS~OINTMENT;TOPICAL~TRAVASE~ABBOTT~82,000 UNITS/GM **Federal Register det
reasons**~N~012828~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATOR
IES PHARMACEUTICAL PRODUCTS DIV
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~ACTAVIS MID ATL
ANTIC~0.1%~A~087799~001~~Jun 7, 1982~No~DISCN~ACTAVIS MID ATLANTIC LLC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~ALPHARMA US PHA
RMS~0.5%~A~089913~001~~Dec 23, 1988~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISIO
N
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~FOUGERA PHARMS~
0.025%~A~085691~001~AT~Approved Prior to Jan 1, 1982~No~RX~FOUGERA PHARMACEUTICA
LS INC
0.1%~A~085691~003~AT~Approved Prior to Jan 1, 1982~No~RX~FOUGERA PHARMACEUTICALS
INC
0.5%~A~085691~002~AT~Approved Prior to Jan 1, 1982~No~RX~FOUGERA PHARMACEUTICALS
INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~G AND W LABS~0.
025%~A~089795~001~~Dec 23, 1988~No~DISCN~G AND W LABORATORIES INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~G AND W LABS~0.
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~MORTON GROVE~0.
025%~A~088090~001~~Sep 1, 1983~No~DISCN~MORTON GROVE PHARMACEUTICALS INC

TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~PERRIGO NEW YOR
K~0.025%~A~087356~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~PERRIGO NEW YORK I
NC
K~0.1%~A~087357~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~PERRIGO NEW YORK INC
K~0.5%~A~087385~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~PERRIGO NEW YORK INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~PHARMADERM~0.02
5%~A~088692~001~~Aug 2, 1984~No~DISCN~PHARMADERM DIV ALTANA INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~PHARMADERM~0.1%
~A~088690~001~~Aug 2, 1984~No~DISCN~PHARMADERM DIV ALTANA INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE~TARO~0.025%~A~0
40040~001~~Sep 30, 1994~No~DISCN~TARO PHARMACEUTICALS INC
40374~001~~Jun 5, 2001~No~DISCN~TARO PHARMACEUTICALS USA INC
037~001~AT~Sep 30, 1994~No~RX~TARO PHARMACEUTICALS INC
902~001~~Dec 27, 1982~No~DISCN~TARO PHARMACEUTICALS USA INC
386~001~~Jun 5, 2001~No~DISCN~TARO PHARMACEUTICALS USA INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRIAMCINOLONE ACETONIDE IN ABSORBASE~CA
ROLINA MEDCL~0.05%~A~089595~001~~Mar 23, 1995~Yes~RX~CAROLINA MEDICAL PRODUCTS C
O
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRYMEX~SAVAGE LABS~0.025%~A~088693~001~
~Aug 2, 1984~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
TRIAMCINOLONE ACETONIDE~OINTMENT;TOPICAL~TRYMEX~SAVAGE LABS~0.1%~A~088691~001~~A
ug 2, 1984~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
HALOBETASOL PROPIONATE~OINTMENT;TOPICAL~ULTRAVATE~RANBAXY~0.05%~N~019968~001~AB~
Dec 17, 1990~Yes~RX~RANBAXY LABORATORIES INC
BETAMETHASONE BENZOATE~OINTMENT;TOPICAL~UTICORT~PARKE DAVIS~0.025%~N~018089~001~
~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
BETAMETHASONE VALERATE~OINTMENT;TOPICAL~VALISONE~SCHERING~EQ 0.1% BASE~N~016740~
001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP
CALCITRIOL~OINTMENT;TOPICAL~VECTICAL~GALDERMA LABS LP~3MCG/GM~N~022087~001~~Jan
23, 2009~Yes~RX~GALDERMA LABORATORIES LP
SINECATECHINS~OINTMENT;TOPICAL~VEREGEN~MEDIGENE AG~15%~N~021902~001~~Oct 31, 200
6~Yes~RX~MEDIGENE AG
MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE~OINTMENT;TOPICAL~VUSION~DELCOR
ASSET~0.25%;81.35%;15%~N~021026~001~~Feb 16, 2006~Yes~RX~DELCOR ASSET CORP
HYDROCORTISONE VALERATE~OINTMENT;TOPICAL~WESTCORT~RANBAXY~0.2%~N~018726~001~~Aug
8, 1983~No~DISCN~RANBAXY LABORATORIES INC
LIDOCAINE~OINTMENT;TOPICAL~XYLOCAINE~ASTRAZENECA~5%~N~008048~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ASTRAZENECA LP
ACYCLOVIR~OINTMENT;TOPICAL~ZOVIRAX~VALEANT BERMUDA~5%~N~018604~001~AB~Mar 29, 19
NITROGLYCERIN~OINTMENT;TRANSDERMAL~NITROGLYCERIN~FOUGERA~2%~A~087355~001~~Jul 8,
1988~Yes~RX~E FOUGERA DIV ALTANA INC
TIOCONAZOLE~OINTMENT;VAGINAL~TIOCONAZOLE~PERRIGO~6.5%~A~075915~001~~Nov 21, 2001
~No~OTC~L PERRIGO CO
TIOCONAZOLE~OINTMENT;VAGINAL~VAGISTAT-1~NOVARTIS~6.5%~N~020676~001~~Feb 11, 1997
~Yes~OTC~NOVARTIS CONSUMER HEALTH INC
CANDICIDIN~OINTMENT;VAGINAL~VANOBID~SANOFI AVENTIS US~0.6MG/GM~A~061596~001~~App
AMLEXANOX~PASTE;DENTAL~APHTHASOL~ULURU~5%~N~020511~001~~Dec 17, 1996~No~DISCN~UL
URU INC
SODIUM FLUORIDE; TRICLOSAN~PASTE;DENTAL~COLGATE TOTAL~COLGATE PALMOLIVE~0.24%;0.

3%~N~020231~001~~Jul 11, 1997~Yes~OTC~COLGATE PALMOLIVE
SODIUM MONOFLUOROPHOSPHATE~PASTE;DENTAL~EXTRA-STRENGTH AIM~CHESEBROUGH PONDS~1.2
%~N~019518~001~~Jun 3, 1987~No~DISCN~CHESEBROUGH PONDS INC
TRIAMCINOLONE ACETONIDE~PASTE;DENTAL~KENALOG IN ORABASE~DELCOR ASSET CORP~0.1%~N
~012097~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELCOR ASSET CORP
TRIAMCINOLONE ACETONIDE~PASTE;DENTAL~ORALONE~TARO~0.1%~A~071383~001~~Jul 6, 1987
~No~DISCN~TARO PHARMACEUTICALS USA INC
TRIAMCINOLONE ACETONIDE~PASTE;DENTAL~TRIAMCINOLONE ACETONIDE~LYNE~0.1%~A~040771~
001~AT~Jul 1, 2010~No~RX~LYNE LABORATORIES INC
TRIAMCINOLONE ACETONIDE~PASTE;DENTAL~TRIAMCINOLONE ACETONIDE~TARO~0.1%~A~070730~
001~AT~Oct 1, 1986~Yes~RX~TARO PHARMACEUTICALS USA INC
HYDROCORTISONE ACETATE~PASTE;TOPICAL~ORABASE HCA~COLGATE~0.5%~A~083205~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~COLGATE ORAL PHARMACEUTICALS INC
PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE~PASTE;TOPICAL~SKIN E
XPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS~US ARMY~50%;50%~N~021084
~001~~Feb 17, 2000~No~DISCN~US ARMY MEDICAL RESEARCH MATERIEL COMMAND
NYSTATIN~PASTILLE;ORAL~MYCOSTATIN~BRISTOL MYERS SQUIBB~200,000 UNITS~N~050619~00
1~~Apr 9, 1987~No~DISCN~BRISTOL MYERS SQUIBB
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~PATCH;IONTOPHORESIS, TOPICAL~LIDOSITE TOPIC
AL SYSTEM KIT~VYTERIS~1.05MG/PATCH;100MG/PATCH~N~021504~001~~May 6, 2004~No~DISC
N~VYTERIS INC
AMLEXANOX~PATCH;TOPICAL~AMLEXANOX~ULURU~2MG~N~021727~001~~Sep 29, 2004~No~DISCN~
ULURU INC
LIDOCAINE~PATCH;TOPICAL~DENTIPATCH~NOVEN~46.1MG/PATCH~N~020575~002~~May 21, 1996
~No~DISCN~NOVEN PHARMACEUTICALS INC
DICLOFENAC EPOLAMINE~PATCH;TOPICAL~FLECTOR~INST BIOCHEM~1.3%~N~021234~001~~Jan 3
1, 2007~Yes~RX~INSTITUT BIOCHEMIQUE SA
LIDOCAINE~PATCH;TOPICAL~LIDOCAINE~WATSON LABS INC~5%~A~200675~001~AB~Aug 23, 201
LIDOCAINE~PATCH;TOPICAL~LIDODERM~TEIKOKU PHARMA USA~5%~N~020612~001~AB~Mar 19, 1
999~Yes~RX~TEIKOKU PHARMA USA INC
CAPSAICIN~PATCH;TOPICAL~QUTENZA~ACORDA~8%~N~022395~001~~Nov 16, 2009~Yes~RX~ACOR
DA THERAPEUTICS INC
MENTHOL; METHYL SALICYLATE~PATCH;TOPICAL~SALONPAS~HISAMITSU PHARM CO~3%;10%~N~02
2029~001~~Feb 20, 2008~Yes~OTC~HISAMITSU PHARMACEUTICAL CO INC
MENTHOL; METHYL SALICYLATE~PATCH;TOPICAL~SALONPAS~HISAMITSU PHARM CO~3%;10%~N~02
2029~002~~Nov 5, 2012~No~OTC~HISAMITSU PHARMACEUTICAL CO INC
LIDOCAINE; TETRACAINE~PATCH;TOPICAL~SYNERA~GALEN SPECIALTY~70MG;70MG~N~021623~00
1~~Jun 23, 2005~Yes~RX~GALEN SPECIALTY PHARMA US LLC
DESOXYCORTICOSTERONE ACETATE~PELLET;IMPLANTATION~PERCORTEN~NOVARTIS~125MG~N~0051
TESTOSTERONE~PELLET;IMPLANTATION~TESTOPEL~ACTIENT PHARMS~75MG~A~080911~001~~Appr
oved Prior to Jan 1, 1982~Yes~RX~ACTIENT PHARMACEUTICALS LLC
MINOCYCLINE HYDROCHLORIDE~POWDER, EXTENDED RELEASE;DENTAL~ARESTIN~ORAPHARMA~EQ 1
MG BASE~N~050781~001~~Feb 16, 2001~Yes~RX~ORAPHARMA INC
BUDESONIDE~POWDER, METERED;INHALATION~PULMICORT~ASTRAZENECA~0.16MG/INH~N~020441~
002~~Jun 24, 1997~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
BUDESONIDE~POWDER, METERED;INHALATION~PULMICORT~ASTRAZENECA~0.32MG/INH~N~020441~
003~~Jun 24, 1997~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
BUDESONIDE~POWDER, METERED;INHALATION~PULMICORT FLEXHALER~ASTRAZENECA~0.08MG/INH
~N~021949~001~~Jul 12, 2006~No~RX~ASTRAZENECA LP
BUDESONIDE~POWDER, METERED;INHALATION~PULMICORT FLEXHALER~ASTRAZENECA~0.16MG/INH
~N~021949~002~~Jul 12, 2006~Yes~RX~ASTRAZENECA LP
ACLIDINIUM BROMIDE~POWDER, METERED;INHALATION~TUDORZA PRESSAIR~FOREST LABS INC~0
.375MG/INH~N~202450~001~~Jul 23, 2012~Yes~RX~FOREST LABORATORIES INC
BACITRACIN~POWDER;FOR RX COMPOUNDING~BACI-RX~X GEN PHARMS~5,000,000 UNITS/BOT~A~
061580~001~~Approved Prior to Jan 1, 1982~No~DISCN~X GEN PHARMACEUTICALS INC
BACITRACIN~POWDER;FOR RX COMPOUNDING~BACITRACIN~APOTHEKERNES~5,000,000 UNITS/BOT
~A~061699~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHEKERNES LABORATORIUM
A/S
BACITRACIN~POWDER;FOR RX COMPOUNDING~BACITRACIN~PADDOCK LLC~5,000,000 UNITS/BOT~
A~062456~001~~Jul 27, 1983~No~DISCN~PADDOCK LABORATORIES LLC
ERYTHROMYCIN~POWDER;FOR RX COMPOUNDING~ERYTHROMYCIN~PADDOCK LLC~100%~N~050610~00
1~~Nov 7, 1986~No~DISCN~PADDOCK LABORATORIES LLC
HYDROCORTISONE~POWDER;FOR RX COMPOUNDING~H-CORT~TORCH~100%~A~087834~001~~Mar 29,
1982~No~DISCN~TORCH LABORATORIES INC
HYDROCORTISONE~POWDER;FOR RX COMPOUNDING~HYDRO-RX~X GEN PHARMS~100%~A~085982~001
~~Approved Prior to Jan 1, 1982~Yes~RX~X GEN PHARMACEUTICALS INC
HYDROCORTISONE~POWDER;FOR RX COMPOUNDING~HYDROCORTISONE~PADDOCK LLC~100%~A~08808
2~001~~Apr 8, 1983~No~DISCN~PADDOCK LABORATORIES LLC
HYDROCORTISONE ACETATE~POWDER;FOR RX COMPOUNDING~HYDROCORTISONE ACETATE~X GEN PH
ARMS~100%~A~085981~001~~Approved Prior to Jan 1, 1982~No~RX~X GEN PHARMACEUTICAL
S INC
METHADONE HYDROCHLORIDE~POWDER;FOR RX COMPOUNDING~METHADONE HYDROCHLORIDE~MALLIN
CKRODT~50GM/BOT~N~006383~002~~Approved Prior to Jan 1, 1982~No~RX~MALLINCKRODT C
HEMICAL INC
CKRODT~100GM/BOT~N~006383~003~~Approved Prior to Jan 1, 1982~No~RX~MALLINCKRODT
CHEMICAL INC
CKRODT~500GM/BOT~N~006383~004~~Approved Prior to Jan 1, 1982~No~RX~MALLINCKRODT
CHEMICAL INC
NEOMYCIN SULFATE~POWDER;FOR RX COMPOUNDING~NEO-RX~X GEN PHARMS~100%~A~061579~001
~~Approved Prior to Jan 1, 1982~No~DISCN~X GEN PHARMACEUTICALS INC
POLYMYXIN B SULFATE~POWDER;FOR RX COMPOUNDING~POLY-RX~X GEN PHARMS~100,000,000 U
NITS/BOT~A~061578~001~~Approved Prior to Jan 1, 1982~No~DISCN~X GEN PHARMACEUTIC
ALS INC
POLYMYXIN B SULFATE~POWDER;FOR RX COMPOUNDING~POLYMYXIN B SULFATE~PADDOCK LLC~10
0,000,000 UNITS/BOT~A~062455~001~~Jul 27, 1983~No~DISCN~PADDOCK LABORATORIES LLC
BACITRACIN ZINC~POWDER;FOR RX COMPOUNDING~ZIBA-RX~X GEN PHARMS~500,000 UNITS/BOT
~A~061737~001~~Approved Prior to Jan 1, 1982~No~DISCN~X GEN PHARMACEUTICALS INC
LOXAPINE~POWDER;INHALATION~ADASUVE~TEVA PHARMS USA INC~10MG~N~022549~001~~Dec 21
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE~POWDER;INHALATION~ADVAIR DISKUS 100
/50~GLAXO GRP LTD~0.1MG/INH;EQ 0.05MG BASE/INH~N~021077~001~~Aug 24, 2000~Yes~RX
~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
/50~GLAXO GRP LTD~0.25MG/INH;EQ 0.05MG BASE/INH~N~021077~002~~Aug 24, 2000~Yes~R
X~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
/50~GLAXO GRP LTD~0.5MG/INH;EQ 0.05MG BASE/INH~N~021077~003~~Aug 24, 2000~Yes~RX
~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
INSULIN RECOMBINANT HUMAN~POWDER;INHALATION~AFREZZA~SANOFI AVENTIS~4 UNITS/INH~N
~022472~001~~Jun 27, 2014~No~RX~SANOFI AVENTIS
INSULIN RECOMBINANT HUMAN~POWDER;INHALATION~AFREZZA~SANOFI AVENTIS~8 UNITS/INH~N
~022472~002~~Jun 27, 2014~Yes~RX~SANOFI AVENTIS
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE~POWDER;INHALATION~ANORO ELLIPTA~GLA
XOSMITHKLINE~EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH~N~203975~001~~Dec 18, 2013
~Yes~RX~GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
INDACATEROL MALEATE~POWDER;INHALATION~ARCAPTA NEOHALER~NOVARTIS~EQ 75MCG BASE~N~
022383~001~~Jul 1, 2011~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
MANNITOL~POWDER;INHALATION~ARIDOL KIT~PHARMAXIS LTD~N/A,5MG,10MG,20MG,40MG~N~022
368~001~~Oct 5, 2010~No~DISCN~PHARMAXIS LTD
FLUTICASONE FUROATE~POWDER;INHALATION~ARNUITY ELLIPTA~GLAXOSMITHKLINE~0.1MG/INH~
N~205625~001~~Aug 20, 2014~No~RX~GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPME
NT LTD ENGLAND
FLUTICASONE FUROATE~POWDER;INHALATION~ARNUITY ELLIPTA~GLAXOSMITHKLINE~0.2MG/INH~
N~205625~002~~Aug 20, 2014~Yes~RX~GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPM
ENT LTD ENGLAND
MOMETASONE FUROATE~POWDER;INHALATION~ASMANEX TWISTHALER~MERCK SHARP DOHME~0.11MG

/INH~N~021067~002~~Feb 1, 2008~No~RX~MERCK SHARP AND DOHME CORP
MOMETASONE FUROATE~POWDER;INHALATION~ASMANEX TWISTHALER~MERCK SHARP DOHME~0.22MG
/INH~N~021067~001~~Mar 30, 2005~Yes~RX~MERCK SHARP AND DOHME CORP
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE~POWDER;INHALATION~BREO ELLIPTA~GLAXO
GRP LTD~0.1MG/INH;EQ 0.025MG BASE/INH~N~204275~001~~May 10, 2013~Yes~RX~GLAXO G
ROUP LTD ENGLAND DBA GLAXOSMITHKLINE
INSULIN RECOMBINANT HUMAN~POWDER;INHALATION~EXUBERA~PFIZER~1MG/INH~N~021868~001~
~Jan 27, 2006~No~DISCN~PFIZER INC
INSULIN RECOMBINANT HUMAN~POWDER;INHALATION~EXUBERA~PFIZER~3MG/INH~N~021868~002~
~Jan 27, 2006~No~DISCN~PFIZER INC
FLUTICASONE PROPIONATE~POWDER;INHALATION~FLOVENT~GLAXOSMITHKLINE~0.044MG/INH~N~0
20549~001~~Nov 7, 1997~No~DISCN~GLAXOSMITHKLINE
FLUTICASONE PROPIONATE~POWDER;INHALATION~FLOVENT DISKUS 100~GLAXO GRP LTD~0.1MG/
INH~N~020833~002~~Sep 29, 2000~Yes~RX~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLIN
E
FLUTICASONE PROPIONATE~POWDER;INHALATION~FLOVENT DISKUS 250~GLAXO GRP LTD~0.25MG
/INH~N~020833~003~~Sep 29, 2000~Yes~RX~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLI
NE
FLUTICASONE PROPIONATE~POWDER;INHALATION~FLOVENT DISKUS 50~GLAXO GRP LTD~0.05MG/
INH~N~020833~001~~Sep 29, 2000~Yes~RX~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLIN
E
FORMOTEROL FUMARATE~POWDER;INHALATION~FORADIL~NOVARTIS~0.012MG/INH~N~020831~001~
~Feb 16, 2001~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
FORMOTEROL FUMARATE~POWDER;INHALATION~FORADIL CERTIHALER~NOVARTIS~0.0085MG/INH~N
~021592~001~~Dec 15, 2006~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
UMECLIDINIUM BROMIDE~POWDER;INHALATION~INCRUSE ELLIPTA ~GLAXO GRP ENGLAND~EQ 62.
5MCG BASE/INH~N~205382~001~~Apr 30, 2014~Yes~RX~GLAXO GROUP LTD ENGLAND DBA GLAX
OSMITHKLINE
ISOPROTERENOL SULFATE~POWDER;INHALATION~NORISODRINE~ABBVIE~10%~N~006905~003~~App
roved Prior to Jan 1, 1982~No~DISCN~ABBVIE INC
ISOPROTERENOL SULFATE~POWDER;INHALATION~NORISODRINE~ABBVIE~25%~N~006905~002~~App
roved Prior to Jan 1, 1982~No~DISCN~ABBVIE INC
ZANAMIVIR~POWDER;INHALATION~RELENZA~GLAXOSMITHKLINE~5MG~N~021036~001~~Jul 26, 19
SALMETEROL XINAFOATE~POWDER;INHALATION~SEREVENT~GLAXOSMITHKLINE~EQ 0.05MG BASE/I
NH~N~020692~001~~Sep 19, 1997~Yes~RX~GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD E
NGLAND
TIOTROPIUM BROMIDE~POWDER;INHALATION~SPIRIVA~BOEHRINGER INGELHEIM~EQ 0.018MG BAS
E/INH~N~021395~001~~Jan 30, 2004~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
TOBRAMYCIN~POWDER;INHALATION~TOBI PODHALER~NOVARTIS~28MG~N~201688~001~~Mar 22, 2
CILASTATIN SODIUM; IMIPENEM~POWDER;INTRAMUSCULAR~PRIMAXIN~MERCK~EQ 500MG BASE/VI
AL;500MG/VIAL~N~050630~001~~Dec 14, 1990~No~RX~MERCK AND CO INC
CILASTATIN SODIUM; IMIPENEM~POWDER;INTRAMUSCULAR~PRIMAXIN~MERCK~EQ 750MG BASE/VI
AL;750MG/VIAL~N~050630~002~~Dec 14, 1990~No~DISCN~MERCK AND CO INC
PASIREOTIDE PAMOATE~POWDER;INTRAMUSCULAR~SIGNIFOR LAR~NOVARTIS PHARMS CORP~EQ 20
MG BASE/VIAL~N~203255~001~~Dec 15, 2014~No~RX~NOVARTIS PHARMACEUTICALS CORP
MG BASE/VIAL~N~203255~002~~Dec 15, 2014~No~RX~NOVARTIS PHARMACEUTICALS CORP
MG BASE/VIAL~N~203255~003~~Dec 15, 2014~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
TALC~POWDER;INTRAPLEURAL~TALC~BRYAN~5GM/BOT~N~021388~001~~Dec 15, 2003~Yes~RX~BR
YAN CORP
AMPICILLIN SODIUM~POWDER;INTRAVENOUS~AMPICILLIN SODIUM~SANDOZ~EQ 1GM BASE/VIAL~A
~062738~001~AP~Feb 19, 1987~Yes~RX~SANDOZ INC
AMPICILLIN SODIUM~POWDER;INTRAVENOUS~AMPICILLIN SODIUM~SANDOZ~EQ 2GM BASE/VIAL~A

~062738~002~AP~Feb 19, 1987~Yes~RX~SANDOZ INC
DECITABINE~POWDER;INTRAVENOUS~DECITABINE~SUN PHARMA GLOBAL~50MG/VIAL~N~205582~00
1~~Jan 28, 2014~Yes~RX~SUN PHARMA GLOBAL FZE
FOSAPREPITANT DIMEGLUMINE~POWDER;INTRAVENOUS~EMEND~MERCK AND CO INC~EQ 115MG BAS
E/VIAL~N~022023~001~~Jan 25, 2008~No~DISCN~MERCK AND CO INC
FOSAPREPITANT DIMEGLUMINE~POWDER;INTRAVENOUS~EMEND~MERCK AND CO INC~EQ 150MG BAS
E/VIAL~N~022023~002~~Nov 12, 2010~Yes~RX~MERCK AND CO INC
CILASTATIN SODIUM; IMIPENEM~POWDER;INTRAVENOUS~IMIPENEM AND CILASTATIN~ACS DOBFA
R~EQ 250MG BASE/VIAL;250MG/VIAL~A~090577~001~AP~Dec 21, 2011~No~RX~ACS DOBFAR SP
A
CILASTATIN SODIUM; IMIPENEM~POWDER;INTRAVENOUS~IMIPENEM AND CILASTATIN~ACS DOBFA
R~EQ 500MG BASE/VIAL;500MG/VIAL~A~090577~002~AP~Dec 21, 2011~No~RX~ACS DOBFAR SP
A
CILASTATIN SODIUM; IMIPENEM~POWDER;INTRAVENOUS~IMIPENEM AND CILASTATIN~HOSPIRA I
NC~EQ 250MG BASE/VIAL;250MG/VIAL~A~090825~001~AP~Nov 16, 2011~No~RX~HOSPIRA INC
CARFILZOMIB~POWDER;INTRAVENOUS~KYPROLIS~ONYX PHARMS~60MG/VIAL~N~202714~001~~Jul
20, 2012~Yes~RX~ONYX PHARMACEUTICALS INC
LEVOTHYROXINE SODIUM~POWDER;INTRAVENOUS~LEVOTHYROXINE SODIUM~FRESENIUS KABI USA~
100MCG/VIAL~N~202231~001~~Jun 24, 2011~Yes~RX~FRESENIUS KABI USA LLC
OXACILLIN SODIUM~POWDER;INTRAVENOUS~OXACILLIN SODIUM~SANDOZ~EQ 1GM BASE/VIAL~A~0
62737~001~AP~Dec 23, 1986~Yes~RX~SANDOZ INC
OXACILLIN SODIUM~POWDER;INTRAVENOUS~OXACILLIN SODIUM~SANDOZ~EQ 2GM BASE/VIAL~A~0
62737~002~AP~Dec 23, 1986~Yes~RX~SANDOZ INC
CILASTATIN SODIUM; IMIPENEM~POWDER;INTRAVENOUS~PRIMAXIN~MERCK~EQ 250MG BASE/VIAL
;250MG/VIAL~N~050587~001~AP~Nov 26, 1985~Yes~RX~MERCK AND CO INC
CILASTATIN SODIUM; IMIPENEM~POWDER;INTRAVENOUS~PRIMAXIN~MERCK~EQ 500MG BASE/VIAL
;500MG/VIAL~N~050587~002~AP~Nov 26, 1985~Yes~RX~MERCK AND CO INC
TEMOZOLOMIDE~POWDER;INTRAVENOUS~TEMODAR~MERCK SHARP DOHME~100MG/VIAL~N~022277~00
1~~Feb 27, 2009~Yes~RX~MERCK SHARP AND DOHME CORP
AVIBACTAM SODIUM; CEFTAZIDIME~POWDER;IV (INFUSION)~AVYCAZ~CEREXA INC~EQ 0.5GM BA
SE;2GM/VIAL~N~206494~001~~Feb 25, 2015~Yes~RX~CEREXA INC
BELINOSTAT~POWDER;IV (INFUSION)~BELEODAQ~SPECTRUM PHARMS~500MG/VIAL~N~206256~001
~~Jul 3, 2014~Yes~RX~SPECTRUM PHARMACEUTICALS INC
TALIGLUCERASE ALFA~POWDER;IV (INFUSION)~ELELYSO~PFIZER~200 UNITS/VIAL~N~022458~0
01~~May 1, 2012~Yes~RX~PFIZER INC
LEVOLEUCOVORIN CALCIUM~POWDER;IV (INFUSION)~FUSILEV~SPECTRUM PHARMS~EQ 50MG BASE
/VIAL~N~020140~001~~Mar 7, 2008~Yes~RX~SPECTRUM PHARMACEUTICALS INC
ROMIDEPSIN~POWDER;IV (INFUSION)~ISTODAX~CELGENE~10MG/VIAL~N~022393~001~~Nov 5, 2
009~Yes~RX~CELGENE CORP
ORITAVANCIN DIPHOSPHATE~POWDER;IV (INFUSION)~ORBACTIV~MEDICINES CO~EQ 400MG BASE
/VIAL~N~206334~001~~Aug 6, 2014~Yes~RX~THE MEDICINES CO
TEDIZOLID PHOSPHATE~POWDER;IV (INFUSION)~SIVEXTRO~CUBIST PHARMS INC~200MG/VIAL~N
~205436~001~~Jun 20, 2014~Yes~RX~CUBIST PHARMACEUTICALS INC
CEFTAROLINE FOSAMIL~POWDER;IV (INFUSION)~TEFLARO~CEREXA~400MG/VIAL~N~200327~001~
~Oct 29, 2010~No~RX~CEREXA INC
CEFTAROLINE FOSAMIL~POWDER;IV (INFUSION)~TEFLARO~CEREXA~600MG/VIAL~N~200327~002~
~Oct 29, 2010~Yes~RX~CEREXA INC
BENDAMUSTINE HYDROCHLORIDE~POWDER;IV (INFUSION)~TREANDA~CEPHALON~25MG/VIAL~N~022
249~002~~May 1, 2009~Yes~RX~CEPHALON INC
BENDAMUSTINE HYDROCHLORIDE~POWDER;IV (INFUSION)~TREANDA~CEPHALON~100MG/VIAL~N~02
2249~001~~Mar 20, 2008~Yes~RX~CEPHALON INC
TELAVANCIN HYDROCHLORIDE~POWDER;IV (INFUSION)~VIBATIV~THERAVANCE BIOPHARMA~EQ 25

0MG BASE/VIAL~N~022110~001~~Sep 11, 2009~No~RX~THERAVANCE BIOPHARMA ANTIBIOTICS
INC
TELAVANCIN HYDROCHLORIDE~POWDER;IV (INFUSION)~VIBATIV~THERAVANCE BIOPHARMA~EQ 75
0MG BASE/VIAL~N~022110~002~~Sep 11, 2009~Yes~RX~THERAVANCE BIOPHARMA ANTIBIOTICS
INC
VELAGLUCERASE ALFA~POWDER;IV (INFUSION)~VPRIV~SHIRE HUMAN GENETIC~200 UNITS/VIAL
~N~022575~002~~Feb 26, 2010~No~DISCN~SHIRE HUMAN GENETIC THERAPIES INC
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM~POWDER;IV (INFUSION)~ZERBAXA~CUBIST PHARM
S~EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL~N~206829~001~~Dec 19, 2014~Yes~RX~CUBIST P
HARMACEUTICALS INC
NYSTATIN~POWDER;ORAL~BARSTATIN 100~BARLAN~100%~A~062489~001~~Apr 27, 1988~No~DIS
CN~BARLAN PHARMACAL CO INC
SODIUM PHENYLBUTYRATE~POWDER;ORAL~BUPHENYL~HYPERION THERAPS INC~3GM/TEASPOONFUL~
N~020573~001~AB~Apr 30, 1996~Yes~RX~HYPERION THERAPEUTICS INC
CELLULOSE SODIUM PHOSPHATE~POWDER;ORAL~CALCIBIND~MISSION PHARMA~2.5GM/PACKET~N~0
18757~002~~Dec 28, 1982~No~DISCN~MISSION PHARMACAL CO
CELLULOSE SODIUM PHOSPHATE~POWDER;ORAL~CALCIBIND~MISSION PHARMA~300GM/BOT~N~0187
57~003~~Oct 16, 1984~No~DISCN~MISSION PHARMACAL CO
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~IVAX SUB TEVA PHARMS~EQ 4GM RESIN/PACK
ET~A~074771~001~~Jul 9, 1997~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACE
UTICALS USA
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~IVAX SUB TEVA PHARMS~EQ 4GM RESIN/SCOO
PFUL~A~074771~002~~Jul 9, 1997~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMA
CEUTICALS USA
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~PAR PHARM~EQ 4GM RESIN/PACKET~A~077204
~001~AB~Aug 26, 2005~No~RX~PAR PHARMACEUTICAL INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~PAR PHARM~EQ 4GM RESIN/SCOOPFUL~A~0772
04~002~AB~Aug 26, 2005~No~RX~PAR PHARMACEUTICAL INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~SANDOZ~EQ 4GM RESIN/PACKET~A~074557~00
1~AB~Aug 15, 1996~Yes~RX~SANDOZ INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~SANDOZ~EQ 4GM RESIN/SCOOPFUL~A~074557~
002~AB~Aug 15, 1996~No~RX~SANDOZ INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~TEVA~EQ 4GM RESIN/PACKET~A~074347~001~
~May 28, 1998~No~DISCN~TEVA PHARMACEUTICALS USA INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~TEVA~EQ 4GM RESIN/SCOOPFUL~A~074347~00
2~~May 28, 1998~No~DISCN~TEVA PHARMACEUTICALS USA INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~TEVA PHARMS~EQ 4GM RESIN/PACKET~A~0745
54~001~~Oct 2, 1996~No~DISCN~TEVA PHARMACEUTICALS USA
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE~TEVA PHARMS~EQ 4GM RESIN/SCOOPFUL~A~07
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE LIGHT~PAR PHARM~EQ 4GM RESIN/PACKET~A~
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE LIGHT~PAR PHARM~EQ 4GM RESIN/SCOOPFUL~
A~077203~002~AB~Aug 26, 2005~No~RX~PAR PHARMACEUTICAL INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE LIGHT~SANDOZ~EQ 4GM RESIN/PACKET~A~074
558~001~AB~Aug 15, 1996~Yes~RX~SANDOZ INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE LIGHT~SANDOZ~EQ 4GM RESIN/SCOOPFUL~A~0
74558~002~AB~Aug 15, 1996~No~RX~SANDOZ INC
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE LIGHT~TEVA~EQ 4GM RESIN/PACKET~A~07434
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE LIGHT~TEVA~EQ 4GM RESIN/SCOOPFUL~A~074
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE LIGHT~TEVA PHARMS~EQ 4GM RESIN/PACKET~
A~074555~001~~Sep 30, 1998~No~DISCN~TEVA PHARMACEUTICALS USA
CHOLESTYRAMINE~POWDER;ORAL~CHOLESTYRAMINE LIGHT~TEVA PHARMS~EQ 4GM RESIN/SCOOPFU
L~A~074555~002~~Sep 30, 1998~No~DISCN~TEVA PHARMACEUTICALS USA
LANTHANUM CARBONATE~POWDER;ORAL~FOSRENOL~SHIRE DEV LLC~EQ 1GM BASE~N~204734~002~
~Sep 24, 2014~Yes~RX~SHIRE DEVELOPMENT LLC
LANTHANUM CARBONATE~POWDER;ORAL~FOSRENOL~SHIRE DEV LLC~EQ 750MG BASE~N~204734~00
1~~Sep 24, 2014~No~RX~SHIRE DEVELOPMENT LLC

RALTEGRAVIR POTASSIUM~POWDER;ORAL~ISENTRESS~MERCK SHARP DOHME~EQ 100MG BASE/PACK
ET~N~205786~001~~Dec 20, 2013~Yes~RX~MERCK SHARP AND DOHME CORP
SAPROPTERIN DIHYDROCHLORIDE~POWDER;ORAL~KUVAN~BIOMARIN PHARM~100MG/PACKET~N~2050
65~001~~Dec 19, 2013~Yes~RX~BIOMARIN PHARMACEUTICAL INC
CHOLESTYRAMINE~POWDER;ORAL~LOCHOLEST~SANDOZ~EQ 4GM RESIN/PACKET~A~074561~001~~Au
g 15, 1996~No~DISCN~SANDOZ INC
CHOLESTYRAMINE~POWDER;ORAL~LOCHOLEST~SANDOZ~EQ 4GM RESIN/SCOOPFUL~A~074561~002~~
Aug 15, 1996~No~DISCN~SANDOZ INC
CHOLESTYRAMINE~POWDER;ORAL~LOCHOLEST LIGHT~SANDOZ~EQ 4GM RESIN/PACKET~A~074562~0
01~~Aug 15, 1996~No~DISCN~SANDOZ INC
CHOLESTYRAMINE~POWDER;ORAL~LOCHOLEST LIGHT~SANDOZ~EQ 4GM RESIN/SCOOPFUL~A~074562
~002~~Aug 15, 1996~No~DISCN~SANDOZ INC
NYSTATIN~POWDER;ORAL~NILSTAT~DAVA PHARMS INC~100%~N~050576~001~~Dec 22, 1983~No~
DISCN~DAVA PHARMACEUTICALS INC
NYSTATIN~POWDER;ORAL~NYSTATIN~PADDOCK LLC~100%~A~062613~001~~Nov 26, 1985~No~DIS
CN~PADDOCK LABORATORIES LLC
AMINOSALICYLATE SODIUM~POWDER;ORAL~P.A.S. SODIUM~CENTURY PHARMS~4GM/PACKET~A~080
947~001~~Approved Prior to Jan 1, 1982~No~DISCN~CENTURY PHARMACEUTICALS INC
PHENYL AMINOSALICYLATE~POWDER;ORAL~PHENY-PAS-TEBAMIN~PHARM RES ASSOC~50%~N~01169
5~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
POTASSIUM AMINOSALICYLATE~POWDER;ORAL~POTASSIUM AMINOSALICYLATE~HEXCEL~100%~A~08
0098~001~~Approved Prior to Jan 1, 1982~No~DISCN~HEXCEL CHEMICAL PRODUCTS
CHOLESTYRAMINE~POWDER;ORAL~PREVALITE~UPSHER SMITH~EQ 4GM RESIN/PACKET~A~073263~0
01~AB~Feb 22, 1996~No~RX~UPSHER SMITH LABORATORIES INC
CHOLESTYRAMINE~POWDER;ORAL~PREVALITE~UPSHER SMITH~EQ 4GM RESIN/SCOOPFUL~A~073263
~002~AB~Oct 30, 1997~No~RX~UPSHER SMITH LABORATORIES INC
CHOLESTYRAMINE~POWDER;ORAL~QUESTRAN~BRISTOL MYERS~EQ 4GM RESIN/PACKET~N~016640~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS CO
CHOLESTYRAMINE~POWDER;ORAL~QUESTRAN~BRISTOL MYERS~EQ 4GM RESIN/SCOOPFUL~N~016640
~003~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS CO
CHOLESTYRAMINE~POWDER;ORAL~QUESTRAN LIGHT~BRISTOL MYERS~EQ 4GM RESIN/PACKET~N~01
9669~001~~Dec 5, 1988~No~DISCN~BRISTOL MYERS CO
CHOLESTYRAMINE~POWDER;ORAL~QUESTRAN LIGHT~BRISTOL MYERS~EQ 4GM RESIN/SCOOPFUL~N~
019669~003~~Dec 5, 1988~No~DISCN~BRISTOL MYERS CO
ATAZANAVIR SULFATE~POWDER;ORAL~REYATAZ~BRISTOL MYERS SQUIBB~EQ 50MG BASE/PACKET~
N~206352~001~~Jun 2, 2014~Yes~RX~BRISTOL MYERS SQUIBB CO
AMINOSALICYLIC ACID RESIN COMPLEX~POWDER;ORAL~REZIPAS~BRISTOL MYERS SQUIBB~EQ 50
0MG BASE/GM~N~009052~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS S
QUIBB CO
AMINOSALICYLATE SODIUM~POWDER;ORAL~SODIUM AMINOSALICYLATE~HEXCEL~100%~A~080097~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~HEXCEL CHEMICAL PRODUCTS
SODIUM PHENYLBUTYRATE~POWDER;ORAL~SODIUM PHENYLBUTYRATE~SIGMAPHARM LABS LLC~3GM/
TEASPOONFUL~A~202819~001~AB~Mar 22, 2013~No~RX~SIGMAPHARM LABORATORIES LLC
NELFINAVIR MESYLATE~POWDER;ORAL~VIRACEPT~AGOURON~EQ 50MG BASE/SCOOPFUL~N~020778~
001~~Mar 14, 1997~No~DISCN~AGOURON PHARMACEUTICALS INC
TENOFOVIR DISOPROXIL FUMARATE~POWDER;ORAL~VIREAD~GILEAD SCIENCES INC~40MG/SCOOPF
UL~N~022577~001~~Jan 18, 2012~Yes~RX~GILEAD SCIENCES INC
XYLOSE~POWDER;ORAL~XYLO-PFAN~SAVAGE LABS~25GM/BOT~N~017605~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
XYLOSE~POWDER;ORAL~XYLOSE~LYNE~25GM/BOT~N~018856~001~~Mar 26, 1987~No~DISCN~LYNE
LABORATORIES INC
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~KALEXATE~KVK TECH~454GM/BOT~A~0
40905~001~AA~Mar 30, 2009~No~RX~KVK TECH INC
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~KAYEXALATE~COVIS PHARMA SARL~45
3.6GM/BOT~N~011287~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~COVIS PHARMA SARL
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~KIONEX~PADDOCK LLC~454GM/BOT~A~
040029~001~AA~Feb 6, 1998~No~RX~PADDOCK LABORATORIES LLC
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~SODIUM POLYSTYRENE SULFONATE~CA
ROLINA MEDCL~454GM/BOT~A~089910~001~AA~Jan 19, 1989~No~RX~CAROLINA MEDICAL PRODU
CTS CO
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~SODIUM POLYSTYRENE SULFONATE~CE
DAR PHARMS~453.6GM/BOT~A~090313~001~AA~Dec 21, 2011~No~RX~CEDAR PHARMACEUTICALS
LLC
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~SODIUM POLYSTYRENE SULFONATE~CI
TRUSPHRMA~454GM/BOT~A~040909~001~~Dec 3, 2008~No~DISCN~CITRUSPHRMA LLC
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~SODIUM POLYSTYRENE SULFONATE~EP
IC PHARMA LLC~453.6GM/BOT~A~202333~001~AA~Mar 19, 2014~No~RX~EPIC PHARMA LLC
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~SODIUM POLYSTYRENE SULFONATE~NU
VO PHARM INC~15GM/BOT~A~204071~002~~Nov 28, 2014~No~RX~NUVO PHARMACEUTICAL INC
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~SODIUM POLYSTYRENE SULFONATE~NU
VO PHARM INC~454GM/BOT~A~204071~001~AA~Nov 28, 2014~No~RX~NUVO PHARMACEUTICAL IN
C
SODIUM POLYSTYRENE SULFONATE~POWDER;ORAL, RECTAL~SODIUM POLYSTYRENE SULFONATE~WO
CKHARDT~453.6GM/BOT~A~088786~001~~Sep 11, 1984~No~DISCN~WOCKHARDT EU OPERATIONS
(SWISS) AG
TESAMORELIN ACETATE~POWDER;SUBCUTANEOUS~EGRIFTA~THERATECHNOLOGIES~EQ 1MG BASE/VI
AL~N~022505~001~~Nov 10, 2010~Yes~RX~THERATECHNOLOGIES INC
TESAMORELIN ACETATE~POWDER;SUBCUTANEOUS~EGRIFTA~THERATECHNOLOGIES~EQ 2MG BASE/VI
AL~N~022505~002~~Nov 29, 2011~No~DISCN~THERATECHNOLOGIES INC
DEGARELIX ACETATE~POWDER;SUBCUTANEOUS~FIRMAGON~FERRING~EQ 80MG BASE/VIAL~N~02220
1~001~~Dec 24, 2008~No~RX~FERRING PHARMACEUTICALS INC
DEGARELIX ACETATE~POWDER;SUBCUTANEOUS~FIRMAGON~FERRING~EQ 120MG BASE/VIAL~N~0222
01~002~~Dec 24, 2008~Yes~RX~FERRING PHARMACEUTICALS INC
TEDUGLUTIDE RECOMBINANT~POWDER;SUBCUTANEOUS~GATTEX KIT~NPS PHARMS INC~5MG/VIAL~N
~203441~001~~Dec 21, 2012~Yes~RX~NPS PHARMACEUTICALS INC
OMACETAXINE MEPESUCCINATE~POWDER;SUBCUTANEOUS~SYNRIBO~IVAX INTL~3.5MG/VIAL~N~203
585~001~~Oct 26, 2012~Yes~RX~IVAX INTERNATIONAL GMBH
SULFUR~POWDER;TOPICAL~BENSULFOID~POYTHRESS~33.32%~N~002918~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~WILLIAM P POYTHRESS AND CO INC
NITROFURAZONE~POWDER;TOPICAL~FURACIN~SHIRE~0.2%~A~083791~001~~Approved Prior to
Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
NYSTATIN~POWDER;TOPICAL~MYCOSTATIN~DELCOR ASSET CORP~100,000 UNITS/GM~A~060578~0
NYSTATIN~POWDER;TOPICAL~NYSTATIN~COASTAL PHARMS~100,000 UNITS/GM~A~065203~001~AT
~Jul 15, 2004~Yes~RX~COASTAL PHARMACEUTICALS
NYSTATIN~POWDER;TOPICAL~NYSTATIN~GAVIS PHARMS~100,000 UNITS/GM~A~065138~001~AT~J
ul 23, 2004~No~RX~GAVIS PHARMACEUTICALS LLC
NYSTATIN~POWDER;TOPICAL~NYSTATIN~NESHER PHARMS~100,000 UNITS/GM~A~065321~001~~Au
g 18, 2006~No~DISCN~NESHER PHARMACEUTICALS USA LLC
NYSTATIN~POWDER;TOPICAL~NYSTATIN~UPSHER SMITH~100,000 UNITS/GM~A~065183~001~AT~M
ay 3, 2005~No~RX~UPSHER SMITH LABORATORIES INC
NYSTATIN~POWDER;TOPICAL~NYSTATIN~X GEN PHARMS~100,000 UNITS/GM~A~065175~001~AT~D
ec 17, 2004~No~RX~X GEN PHARMACEUTICALS INC
NYSTATIN~POWDER;TOPICAL~NYSTOP~PADDOCK LLC~100,000 UNITS/GM~A~064118~001~AT~Aug
ETHINYL ESTRADIOL; ETONOGESTREL~RING;VAGINAL~NUVARING~ORGANON USA INC~0.015MG/24
HR;0.12MG/24HR~N~021187~001~~Oct 3, 2001~Yes~RX~ORGANON USA INC
FLUOCINOLONE ACETONIDE~SHAMPOO;TOPICAL~CAPEX~GALDERMA LABS LP~0.01%~N~020001~001
~~Aug 27, 1990~Yes~RX~GALDERMA LABORATORIES LP
CHLOROXINE~SHAMPOO;TOPICAL~CAPITROL~WESTWOOD SQUIBB~2%~N~017594~001~~Approved Pr
CICLOPIROX~SHAMPOO;TOPICAL~CICLOPIROX~ACTAVIS MID ATLANTIC~1%~A~090490~001~AT~No
v 24, 2009~No~RX~ACTAVIS MID ATLANTIC LLC
CICLOPIROX~SHAMPOO;TOPICAL~CICLOPIROX~FOUGERA PHARMS~1%~A~090146~001~AT~May 25,
CICLOPIROX~SHAMPOO;TOPICAL~CICLOPIROX~PERRIGO~1%~A~078594~001~AT~Feb 16, 2010~No
~RX~PERRIGO CO
CICLOPIROX~SHAMPOO;TOPICAL~CICLOPIROX~TARO~1%~A~090269~001~AT~Feb 23, 2011~No~RX
~TARO PHARMACEUTICALS USA INC
CLOBETASOL PROPIONATE~SHAMPOO;TOPICAL~CLOBETASOL PROPIONATE~ACTAVIS MID ATLANTIC

~0.05%~A~078854~001~AB~Jun 7, 2011~No~RX~ACTAVIS MID ATLANTIC LLC
CLOBETASOL PROPIONATE~SHAMPOO;TOPICAL~CLOBETASOL PROPIONATE~PERRIGO ISRAEL~0.05%
~A~090974~001~AB~Aug 9, 2012~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
CLOBETASOL PROPIONATE~SHAMPOO;TOPICAL~CLOBEX~GALDERMA LABS~0.05%~N~021644~001~AB
~Feb 5, 2004~Yes~RX~GALDERMA LABORATORIES INC
LINDANE~SHAMPOO;TOPICAL~GAMENE~SOLA BARNES HIND~1%~A~084988~001~~Approved Prior
to Jan 1, 1982~No~DISCN~SOLA BARNES HIND
KETOCONAZOLE~SHAMPOO;TOPICAL~KETOCONAZOLE~PERRIGO NEW YORK~2%~A~076419~001~AB~Ja
n 7, 2004~No~RX~PERRIGO NEW YORK INC
KETOCONAZOLE~SHAMPOO;TOPICAL~KETOCONAZOLE~TOLMAR~2%~A~076942~001~AB~Apr 11, 2005
~No~RX~TOLMAR INC
LINDANE~SHAMPOO;TOPICAL~KWELL~REED AND CARNRICK~1%~A~084219~001~~Approved Prior
to Jan 1, 1982~No~DISCN~REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
LINDANE~SHAMPOO;TOPICAL~KWELL~REED AND CARNRICK~1%~N~010718~001~~Approved Prior
to Jan 1, 1982~No~DISCN~REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
LINDANE~SHAMPOO;TOPICAL~LINDANE~OLTA PHARMS~1%~A~087266~001~AT~Approved Prior to
Jan 1, 1982~No~RX~OLTA PHARMACEUTICALS CORP
LINDANE~SHAMPOO;TOPICAL~LINDANE~WOCKHARDT~1%~A~088191~001~AT~Sep 18, 1984~Yes~RX
~WOCKHARDT EU OPERATIONS (SWISS) AG
CICLOPIROX~SHAMPOO;TOPICAL~LOPROX~MEDICIS~1%~N~021159~001~AT~Feb 28, 2003~Yes~RX
~MEDICIS PHARMACEUTICAL CORP
KETOCONAZOLE~SHAMPOO;TOPICAL~NIZORAL~JANSSEN PHARMS~2%~N~019927~001~AB~Aug 31, 1
KETOCONAZOLE~SHAMPOO;TOPICAL~NIZORAL A-D~JOHNSON AND JOHNSON~1%~N~020310~001~~Oc
t 10, 1997~Yes~OTC~JOHNSON AND JOHNSON HEALTHCARE PRODUCTS DIV MCNEIL-PPC INC
LINDANE~SHAMPOO;TOPICAL~SCABENE~STIEFEL~1%~A~087940~001~~Apr 8, 1983~No~DISCN~ST
IEFEL LABORATORIES INC
HEXACHLOROPHENE~SOAP;TOPICAL~GAMOPHEN~ARBROOK~2%~N~006270~003~~Approved Prior to
Jan 1, 1982~No~DISCN~ARBROOK INC
SODIUM CHLORIDE~SOLUTION FOR SLUSH;IRRIGATION~SODIUM CHLORIDE 0.9% IN STERILE PL
ASTIC CONTAINER~BAXTER HLTHCARE~900MG/100ML~N~019319~002~~May 17, 1985~No~RX~BAX
TER HEALTHCARE CORP
THEOPHYLLINE~SOLUTION, ELIXIR;ORAL~ELIXOPHYLLIN~SUN PHARM INDS INC~80MG/15ML~A~0
85186~001~~Approved Prior to Jan 1, 1982~Yes~RX~SUN PHARMACEUTICAL INDUSTRIES IN
C
TIMOLOL MALEATE~SOLUTION, GEL FORMING/DROPS;OPHTHALMIC~TIMOLOL MALEATE~ALCON RES
LTD~EQ 0.25% BASE~N~020963~001~AB~Oct 21, 1998~No~RX~ALCON RESEARCH LTD
TIMOLOL MALEATE~SOLUTION, GEL FORMING/DROPS;OPHTHALMIC~TIMOLOL MALEATE~ALCON RES
LTD~EQ 0.5% BASE~N~020963~002~AB~Oct 21, 1998~No~RX~ALCON RESEARCH LTD
TIMOLOL MALEATE~SOLUTION, GEL FORMING/DROPS;OPHTHALMIC~TIMOPTIC-XE~VALEANT PHARM
S LLC~EQ 0.25% BASE~N~020330~001~AB~Nov 4, 1993~Yes~RX~VALEANT PHARMACEUTICALS N
ORTH AMERICA LLC
TIMOLOL MALEATE~SOLUTION, GEL FORMING/DROPS;OPHTHALMIC~TIMOPTIC-XE~VALEANT PHARM
S LLC~EQ 0.5% BASE~N~020330~002~AB~Nov 4, 1993~Yes~RX~VALEANT PHARMACEUTICALS NO
RTH AMERICA LLC
TESTOSTERONE~SOLUTION, METERED;TRANSDERMAL~AXIRON~ELI LILLY AND CO~30MG/1.5ML AC
TUATION~N~022504~001~~Nov 23, 2010~Yes~RX~ELI LILLY AND CO
SODIUM NITRITE; SODIUM THIOSULFATE~SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS~N
ITHIODOTE~HOPE PHARMS~300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)~N~201444
~001~~Jan 14, 2011~Yes~RX~HOPE PHARMACEUTICALS
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~ACULAR~ALLERGAN~0.5%~N~019700~0
01~AT~Nov 9, 1992~Yes~RX~ALLERGAN INC
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~ACULAR LS~ALLERGAN~0.4%~N~02152
8~001~AT~May 30, 2003~Yes~RX~ALLERGAN
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~ACULAR PRESERVATIVE FREE~ALLERG
AN~0.5%~N~020811~001~~Nov 3, 1997~No~DISCN~ALLERGAN INC
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~ACUVAIL~ALLERGAN~0.45%~N~022427
~001~AT~Jul 22, 2009~Yes~RX~ALLERGAN INC
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AK-PENTOLATE~AKORN~1%~A~0

LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AKBETA~AKORN~0.25%~A~074779~
001~AT~Oct 29, 1996~No~RX~AKORN INC
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AKBETA~AKORN~0.5%~A~074780~0
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AKPENTOLATE~AKORN~1%~A~04
0164~001~AT~Jan 13, 1997~No~RX~AKORN INC
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AKPENTOLATE~AKORN~2%~A~04
0165~001~~Jan 13, 1997~No~DISCN~AKORN INC
DIPIVEFRIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AKPRO~AKORN~0.1%~A~074382~001
~~Sep 29, 1995~No~DISCN~AKORN INC
TOBRAMYCIN~SOLUTION/DROPS;OPHTHALMIC~AKTOB~AKORN~0.3%~A~064096~001~AT~Jan 31, 19
96~No~RX~AKORN INC
PEMIROLAST POTASSIUM~SOLUTION/DROPS;OPHTHALMIC~ALAMAST~SANTEN~0.1%~N~021079~001~
~Sep 24, 1999~No~DISCN~SANTEN INC
KETOTIFEN FUMARATE~SOLUTION/DROPS;OPHTHALMIC~ALAWAY~BAUSCH AND LOMB~EQ 0.025% BA
SE~N~021996~001~~Dec 1, 2006~Yes~OTC~BAUSCH AND LOMB INC
KETOTIFEN FUMARATE~SOLUTION/DROPS;OPHTHALMIC~ALAWAY~BAUSCH AND LOMB~EQ 0.035% BA
SE~N~021996~002~~Feb 11, 2015~No~OTC~BAUSCH AND LOMB INC
NAPHAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~ALBALON~ALLERGAN~0.1% **Fede
fety or efficacy reasons**~A~080248~001~~Approved Prior to Jan 1, 1982~No~DISCN~
ALLERGAN INC
PROPARACAINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~ALCAINE~ALCON~0.5%~A~080027
~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
NEDOCROMIL SODIUM~SOLUTION/DROPS;OPHTHALMIC~ALOCRIL~ALLERGAN~2%~N~021009~001~AT~
Dec 8, 1999~Yes~RX~ALLERGAN INC
LODOXAMIDE TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~ALOMIDE~ALCON~EQ 0.1% BASE~N~0
20191~001~~Sep 23, 1993~Yes~RX~ALCON LABORATORIES INC
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~ALPHAGAN~ALLERGAN~0.2%~N~020613~0
01~~Sep 6, 1996~No~DISCN~ALLERGAN INC
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~ALPHAGAN~ALLERGAN~0.5%~N~020490~0
01~~Mar 13, 1997~No~DISCN~ALLERGAN INC
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~ALPHAGAN P~ALLERGAN~0.1%~N~021770
~001~~Aug 19, 2005~Yes~RX~ALLERGAN
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~ALPHAGAN P~ALLERGAN~0.15%~N~02126
2~001~AT~Mar 16, 2001~Yes~RX~ALLERGAN INC
APRACLONIDINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~APRACLONIDINE HYDROCHLORID
E~AKORN INC~EQ 0.5% BASE~A~077764~001~AT~Mar 12, 2009~No~RX~AKORN INC
ATROPINE SULFATE~SOLUTION/DROPS;OPHTHALMIC~ATROPINE SULFATE~AKORN~1%~N~206289~00
1~~Jul 18, 2014~No~RX~AKORN INC
AZITHROMYCIN~SOLUTION/DROPS;OPHTHALMIC~AZASITE~OAK PHARMS INC~1%~N~050810~001~~A
pr 27, 2007~Yes~RX~OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
AZELASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AZELASTINE HYDROCHLORIDE~ALCO
N PHARMA~0.05%~A~202305~001~AT~May 31, 2012~No~RX~ALCON RESEARCH LTD
AZELASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AZELASTINE HYDROCHLORIDE~APOT
EX INC~0.05%~A~078621~001~AT~Aug 3, 2009~No~RX~APOTEX INC RICHMOND HILL
AZELASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~AZELASTINE HYDROCHLORIDE~SUN
PHARMA GLOBAL~0.05%~A~078738~001~AT~Jun 21, 2010~No~RX~SUN PHARMA GLOBAL INC
BENOXINATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~BENOXINATE HYDROCHLORIDE~SOLA
BARNES HIND~0.4%~A~084149~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLA BARN
ES HIND
BEPOTASTINE BESILATE~SOLUTION/DROPS;OPHTHALMIC~BEPREVE~BAUSCH AND LOMB INC~1.5%~
N~022288~001~~Sep 8, 2009~Yes~RX~BAUSCH AND LOMB INC
POVIDONE-IODINE~SOLUTION/DROPS;OPHTHALMIC~BETADINE~ALCON PHARMS LTD~5%~N~018634~
001~~Dec 17, 1986~Yes~RX~ALCON PHARMACEUTICALS LTD
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~BETAGAN~ALLERGAN~0.25%~N~019
814~001~AT~Jun 28, 1989~Yes~RX~ALLERGAN PHARMACEUTICAL
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~BETAGAN~ALLERGAN~0.5%~N~0192
19~002~AT~Dec 19, 1985~Yes~RX~ALLERGAN PHARMACEUTICAL
BETAXOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~BETAXOLOL HYDROCHLORIDE~AKORN~

EQ 0.5% BASE~A~075386~001~AT~Jun 30, 2000~No~RX~AKORN INC
BETAXOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~BETAXOLOL HYDROCHLORIDE~APOTEX
INC~EQ 0.5% BASE~A~075446~001~~Sep 28, 2000~No~DISCN~APOTEX INC
BETAXOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~BETAXOLOL HYDROCHLORIDE~IGI LA
BS INC~EQ 0.5% BASE~A~075630~001~AT~Apr 12, 2001~No~RX~IGI LABORATORIES INC
BETAXOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~BETAXOLOL HYDROCHLORIDE~WOCKHA
RDT~EQ 0.5% BASE~A~078694~001~AT~Nov 16, 2009~No~RX~WOCKHARDT LTD
TIMOLOL~SOLUTION/DROPS;OPHTHALMIC~BETIMOL~OAK PHARMS INC~EQ 0.25% BASE~N~020439~
001~~Mar 31, 1995~Yes~RX~OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
TIMOLOL~SOLUTION/DROPS;OPHTHALMIC~BETIMOL~OAK PHARMS INC~EQ 0.5% BASE~N~020439~0
02~~Mar 31, 1995~Yes~RX~OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
BETAXOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~BETOPTIC~ALCON~EQ 0.5% BASE~N~
019270~001~AT~Aug 30, 1985~Yes~RX~ALCON LABORATORIES INC
BIMATOPROST~SOLUTION/DROPS;OPHTHALMIC~BIMATOPROST~LUPIN LTD~0.03%~A~203991~001~A
T~Feb 20, 2015~Yes~RX~LUPIN LTD
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~BLEPH-10~ALLERGAN~10%~A~080028~00
1~AT~Approved Prior to Jan 1, 1982~Yes~RX~ALLERGAN
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~BLEPH-30~ALLERGAN~30%~A~080028~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~BRIMONIDINE TARTRATE~AKORN~0.2%~A
~076439~001~AT~Mar 14, 2006~No~RX~AKORN INC
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~BRIMONIDINE TARTRATE~ALCON PHARMS
LTD~0.2%~A~076254~001~AT~Sep 16, 2003~No~RX~ALCON PHARMACEUTICALS LTD
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~BRIMONIDINE TARTRATE~BAUSCH AND L
OMB~0.2%~A~076260~001~AT~May 28, 2003~Yes~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~BRIMONIDINE TARTRATE~INDOCO REMED
IES~0.2%~A~091691~001~AT~Nov 18, 2014~No~RX~INDOCO REMEDIES LTD
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~BRIMONIDINE TARTRATE~SANDOZ~0.2%~
A~078075~001~AT~Jan 30, 2008~No~RX~SANDOZ CANADA INC
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~BRIMONIDINE TARTRATE~TEVA PARENTE
RAL~0.2%~A~076372~001~~Sep 10, 2004~No~DISCN~TEVA PARENTERAL MEDICINES INC
BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~BROMDAY~BAUSCH AND LOMB INC~EQ 0.09%
ACID~N~021664~002~AT~Oct 16, 2010~Yes~RX~BAUSCH AND LOMB INC
BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~BROMFENAC SODIUM~APOTEX INC~EQ 0.09%
ACID~A~202435~001~AT1~Jun 19, 2014~No~RX~APOTEX INC
BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~BROMFENAC SODIUM~APOTEX INC~EQ 0.09%
ACID~A~202620~001~AT~Jun 23, 2014~No~RX~APOTEX INC
BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~BROMFENAC SODIUM~COASTAL PHARMS~EQ 0.
09% ACID~A~201211~001~AT1~May 11, 2011~No~RX~COASTAL PHARMACEUTICALS
BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~BROMFENAC SODIUM~HI-TECH PHARMACAL~EQ
0.09% ACID~A~203395~001~AT~Jan 22, 2014~No~RX~HI-TECH PHARMACAL CO INC
BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~BROMFENAC SODIUM~LUITPOLD~EQ 0.09% AC
ID~A~202030~001~AT1~Jan 9, 2013~No~RX~LUITPOLD PHARMACEUTICALS INC
BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~BROMFENAC SODIUM~PADDOCK LLC~EQ 0.09%
ACID~A~201941~001~AT1~Feb 10, 2015~No~RX~PADDOCK LABORATORIES LLC
CARTEOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CARTEOLOL HYDROCHLORIDE~ALCON~
1%~A~075476~001~AT~Jan 3, 2000~No~RX~ALCON LABORATORIES INC
CARTEOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CARTEOLOL HYDROCHLORIDE~APOTEX
INC~1%~A~076097~001~~Feb 6, 2002~No~DISCN~APOTEX INC
CARTEOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CARTEOLOL HYDROCHLORIDE~BAUSCH
AND LOMB~1%~A~075546~001~AT~Jan 20, 2000~No~RX~BAUSCH AND LOMB INC
NORFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~CHIBROXIN~MERCK~0.3%~N~019757~001~~Jun 17,
1991~No~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
CHLORAMPHENICOL~SOLUTION/DROPS;OPHTHALMIC~CHLORAMPHENICOL~AKORN~0.5%~A~062042~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~AKORN INC
CHLORAMPHENICOL~SOLUTION/DROPS;OPHTHALMIC~CHLORAMPHENICOL~ALCON~0.5%~A~062628~00
1~~Sep 25, 1985~No~DISCN~ALCON LABORATORIES INC
CHLORAMPHENICOL~SOLUTION/DROPS;OPHTHALMIC~CHLOROFAIR~PHARMAFAIR~0.5%~A~062437~00
1~~Apr 14, 1983~No~DISCN~PHARMAFAIR INC
CHLORAMPHENICOL~SOLUTION/DROPS;OPHTHALMIC~CHLOROPTIC~ALLERGAN~0.5%~N~050091~001~
~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTICAL
CIPROFLOXACIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CILOXAN~ALCON PHARMS LTD~E
Q 0.3% BASE~N~019992~001~AT~Dec 31, 1990~Yes~RX~ALCON PHARMACEUTICALS LTD
CIPROFLOXACIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CIPROFLOXACIN HYDROCHLORID
E~AKORN INC~EQ 0.3% BASE~A~076555~001~AT~Dec 11, 2008~No~RX~AKORN INC
E~APOTEX INC~EQ 0.3% BASE~A~075928~001~~Jun 9, 2004~No~DISCN~APOTEX INC
E~FDC LTD~EQ 0.3% BASE~A~077568~001~AT~Jun 30, 2008~No~RX~FDC LTD
E~IGI LABS INC~EQ 0.3% BASE~A~076754~001~AT~Jun 9, 2004~No~RX~IGI LABORATORIES I
NC
E~NEXUS PHARMS~EQ 0.3% BASE~A~077689~001~AT~Dec 13, 2006~No~RX~NEXUS PHARMACEUTI
CALS INC
E~PHARMAFORCE~EQ 0.3% BASE~A~078598~001~AT~Jan 16, 2008~No~RX~PHARMAFORCE INC
E~WATSON LABS INC~EQ 0.3% BASE~A~076673~001~AT~Jan 21, 2005~No~RX~WATSON LABORAT
ORIES INC
BRIMONIDINE TARTRATE; TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~COMBIGAN~ALLERGA
N~0.2%;EQ 0.5% BASE~N~021398~001~~Oct 30, 2007~Yes~RX~ALLERGAN INC
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~COSOPT~OAK
PHARMS INC~EQ 2% BASE;EQ 0.5% BASE~N~020869~001~AT~Apr 7, 1998~Yes~RX~OAK PHARMA
CEUTICALS INC SUBSIDIARY OF AKORN INC
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~COSOPT PF~O
AK PHARMS INC~EQ 2% BASE;EQ 0.5% BASE~N~202667~001~~Feb 1, 2012~Yes~RX~OAK PHARM
ACEUTICALS INC SUBSIDIARY OF AKORN INC
CROMOLYN SODIUM~SOLUTION/DROPS;OPHTHALMIC~CROLOM~BAUSCH AND LOMB~4%~A~074443~001
~AT~Jan 30, 1995~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
CROMOLYN SODIUM~SOLUTION/DROPS;OPHTHALMIC~CROMOLYN SODIUM~AKORN~4%~A~074706~001~
AT~Apr 29, 1998~Yes~RX~AKORN INC
CROMOLYN SODIUM~SOLUTION/DROPS;OPHTHALMIC~CROMOLYN SODIUM~ALCON~4%~A~075282~001~
AT~Jun 16, 1999~No~RX~ALCON LABORATORIES INC
CROMOLYN SODIUM~SOLUTION/DROPS;OPHTHALMIC~CROMOLYN SODIUM~APOTEX INC~4%~A~075615
~001~~Jan 26, 2001~No~DISCN~APOTEX INC
CROMOLYN SODIUM~SOLUTION/DROPS;OPHTHALMIC~CROMOPTIC~KING PHARMS~4%~A~075088~001~
~Apr 27, 1999~No~DISCN~KING PHARMACEUTICALS INC
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CYCLOGYL~ALCON~0.5%~A~084
109~001~~Approved Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CYCLOGYL~ALCON~1%~A~08411
0~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CYCLOGYL~ALCON LABS INC~2
%~A~084108~001~~Approved Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHAL
MIC~CYCLOMYDRIL~ALCON~0.2%;1%~A~084300~001~~Approved Prior to Jan 1, 1982~Yes~RX
~ALCON LABORATORIES INC
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CYCLOPENTOLATE HYDROCHLOR
IDE~ALCON PHARMS LTD~1%~A~089162~001~~Jan 24, 1991~No~DISCN~ALCON PHARMACEUTICAL
S LTD
IDE~SOLA BARNES HIND~1%~A~084150~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOL
A BARNES HIND
IDE~SOLA BARNES HIND~1%~A~084863~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOL
A BARNES HIND
CYSTEAMINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~CYSTARAN~SIGMA TAU~EQ 0.44% B
ASE~N~200740~001~~Oct 2, 2012~Yes~RX~SIGMA TAU PHARMACEUTICALS INC
DAPIPRAZOLE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DAPIPRAZOLE HYDROCHLORIDE~FE
RA PHARMS~0.5%~N~019849~001~~Dec 31, 1990~No~DISCN~FERA PHARMACEUTICALS LLC

IDOXURIDINE~SOLUTION/DROPS;OPHTHALMIC~DENDRID~ALCON~0.1%~N~014169~001~AT~Approve
d Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
DEXAMETHASONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~DEXAIR~PHARMAFAIR~EQ 0.
1% PHOSPHATE~A~088433~001~~Dec 15, 1983~No~DISCN~PHARMAFAIR INC
DEXAMETHASONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~DEXAMETHASONE SODIUM PH
OSPHATE~SOLA BARNES HIND~EQ 0.1% PHOSPHATE~A~084170~001~~Approved Prior to Jan 1
, 1982~No~DISCN~SOLA BARNES HIND
DEXAMETHASONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~DEXAMETHASONE SODIUM PH
OSPHATE~SOLA BARNES HIND~EQ 0.1% PHOSPHATE~A~084173~001~~Approved Prior to Jan 1
, 1982~No~DISCN~SOLA BARNES HIND
DICLOFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~DICLOFENAC SODIUM~AKORN~0.1%~A~07784
5~001~AT~Apr 17, 2008~No~RX~AKORN INC
DICLOFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~DICLOFENAC SODIUM~ALCON PHARMS LTD~0
.1%~A~078031~001~AT~Feb 6, 2008~No~RX~ALCON PHARMACEUTICALS LTD
DICLOFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~DICLOFENAC SODIUM~APOTEX INC~0.1%~A~
077600~001~~Nov 13, 2008~No~DISCN~APOTEX INC
DICLOFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~DICLOFENAC SODIUM~BAUSCH AND LOMB~0.
1%~A~078792~001~AT~Dec 28, 2007~No~RX~BAUSCH AND LOMB INC
DICLOFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~DICLOFENAC SODIUM~FALCON PHARMS~0.1%
~N~020809~001~~May 4, 1998~No~DISCN~FALCON PHARMACEUTICALS LTD
DICLOFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~DICLOFENAC SODIUM~NEXUS PHARMS~0.1%~
A~078553~001~AT~Dec 28, 2007~No~RX~NEXUS PHARMACEUTICALS INC
DIPIVEFRIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DIPIVEFRIN HYDROCHLORIDE~BAUS
CH AND LOMB~0.1%~A~074188~001~~May 19, 1995~No~DISCN~BAUSCH AND LOMB PHARMACEUTI
CALS INC
DIPIVEFRIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DIPIVEFRIN HYDROCHLORIDE~FALC
ON PHARMS~0.1%~A~073636~001~~Jun 30, 1994~No~DISCN~FALCON PHARMACEUTICALS LTD
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~AL
CON PHARMS LTD~EQ 2% BASE~A~078981~001~AT~Apr 13, 2009~No~RX~ALCON PHARMACEUTICA
LS LTD
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~AP
OTEX INC~EQ 2% BASE~A~078395~001~~Oct 28, 2008~No~DISCN~APOTEX INC
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~BA
USCH AND LOMB~EQ 2% BASE~A~090143~001~AT~Jun 25, 2009~No~RX~BAUSCH AND LOMB INC
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~HI
TECH PHARMA~EQ 2% BASE~A~077846~001~AT~Oct 28, 2008~No~RX~HI TECH PHARMACAL CO
INC
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~LU
ITPOLD~EQ 2% BASE~A~079186~001~AT~Nov 18, 2009~No~RX~LUITPOLD PHARMACEUTICALS IN
C
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~SA
NDOZ~EQ 2% BASE~A~078748~001~AT~Nov 6, 2008~No~RX~SANDOZ CANADA INC
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~TE
VA PHARMS~EQ 2% BASE~A~078756~001~AT~Dec 4, 2008~No~RX~TEVA PHARMACEUTICALS USA
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~WA
TSON LABS INC~EQ 2% BASE~A~202053~001~AT~Sep 11, 2014~No~RX~WATSON LABORATORIES
INC
DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE HYDROCHLORIDE~ZA
CH SYSTEMS~EQ 2% BASE~A~091034~001~AT~Dec 4, 2013~No~RX~ZACH SYSTEMS SPA
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE~AKORN INC~EQ 2% BASE;EQ 0.5% BASE~A~203058~00
1~AT~Sep 22, 2014~No~RX~AKORN INC
HYDROCHLORIDE AND TIMOLOL MALEATE~ALCON RES~EQ 2% BASE;EQ 0.5% BASE~A~090604~00
1~AT~Nov 18, 2009~No~RX~ALCON RESEARCH LTD
HYDROCHLORIDE AND TIMOLOL MALEATE~APOTEX INC~EQ 2% BASE;EQ 0.5% BASE~A~078201~0
01~~Oct 28, 2008~No~DISCN~APOTEX INC
HYDROCHLORIDE AND TIMOLOL MALEATE~BAUSCH AND LOMB~EQ 2% BASE;EQ 0.5% BASE~A~090

037~001~AT~Jul 14, 2009~No~RX~BAUSCH AND LOMB INC
HYDROCHLORIDE AND TIMOLOL MALEATE~HI TECH PHARMA~EQ 2% BASE;EQ 0.5% BASE~A~0778
47~001~AT~Oct 28, 2008~No~RX~HI TECH PHARMACAL CO INC
HYDROCHLORIDE AND TIMOLOL MALEATE~LANNETT HOLDINGS INC~EQ 2% BASE;EQ 0.5% BASE~
A~201998~001~AT~Dec 17, 2014~No~RX~LANNETT HOLDINGS INC
HYDROCHLORIDE AND TIMOLOL MALEATE~SANDOZ~EQ 2% BASE;EQ 0.5% BASE~A~078749~001~A
T~Nov 6, 2008~No~RX~SANDOZ INC
HYDROCHLORIDE AND TIMOLOL MALEATE~TEVA PHARMS~EQ 2% BASE;EQ 0.5% BASE~A~078704~
001~AT~Sep 28, 2009~No~RX~TEVA PHARMACEUTICALS USA
HYDROCHLORIDE AND TIMOLOL MALEATE~WATSON LABS INC~EQ 2% BASE;EQ 0.5% BASE~A~202
054~001~AT~Sep 3, 2014~No~RX~WATSON LABORATORIES INC
HYDROCHLORIDE AND TIMOLOL MALEATE~ZACH SYSTEMS~EQ 2% BASE;EQ 0.5% BASE~A~091180
~001~AT~Dec 4, 2013~No~RX~ZACH SYSTEMS SPA
CHLORAMPHENICOL~SOLUTION/DROPS;OPHTHALMIC~ECONOCHLOR~ALCON~0.5%~A~061645~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
EPINASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~ELESTAT~ALLERGAN~0.05%~N~0215
65~001~AT~Oct 16, 2003~Yes~RX~ALLERGAN INC
EMEDASTINE DIFUMARATE~SOLUTION/DROPS;OPHTHALMIC~EMADINE~ALCON~0.05%~N~020706~001
~~Dec 29, 1997~Yes~RX~ALCON LABORATORIES INC
EPINASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~EPINASTINE HYDROCHLORIDE~APOT
EX~0.05%~A~090919~001~AT~Oct 31, 2011~No~RX~APOTEX INC
EPINASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~EPINASTINE HYDROCHLORIDE~BREC
KENRIDGE PHARM~0.05%~A~090870~001~AT~Mar 14, 2011~No~RX~BRECKENRIDGE PHARMACEUTI
CAL INC
EPINASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~EPINASTINE HYDROCHLORIDE~GAVI
S PHARMS LLC~0.05%~A~090951~001~AT~Oct 31, 2011~No~RX~GAVIS PHARMACEUTICALS LLC
EPINASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~EPINASTINE HYDROCHLORIDE~SUN
PHARM INDS~0.05%~A~091626~001~AT~Oct 31, 2011~No~RX~SUN PHARMACEUTICAL INDUSTRIE
S LTD
FLURBIPROFEN SODIUM~SOLUTION/DROPS;OPHTHALMIC~FLURBIPROFEN SODIUM~BAUSCH AND LOM
B~0.03%~A~074447~001~AT~Jan 4, 1995~No~RX~BAUSCH AND LOMB INC
SULFISOXAZOLE DIOLAMINE~SOLUTION/DROPS;OPHTHALMIC~GANTRISIN~ROCHE~EQ 4% BASE~N~0
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GARAMYCIN~SCHERING~EQ 0.3% BASE~N~0
50039~002~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLO
UGH CORP
GATIFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~GATIFLOXACIN~APOTEX INC~0.3%~A~079084~001
~~Aug 19, 2011~No~DISCN~APOTEX INC
GATIFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~GATIFLOXACIN~HI-TECH PHARMA CO~0.5%~A~203
189~001~AT~Sep 3, 2014~No~RX~HI-TECH PHARMACAL CO INC
GATIFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~GATIFLOXACIN~LUPIN LTD~0.5%~A~202653~001~
AT~Aug 28, 2013~No~RX~LUPIN LTD
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENOPTIC~ALLERGAN~EQ 0.3% BASE~A~06
2452~001~AT~Oct 10, 1984~No~RX~ALLERGAN
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTACIDIN~NOVARTIS~EQ 0.3% BASE~A~
062480~001~~Mar 30, 1984~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTAFAIR~PHARMAFAIR~EQ 0.3% BASE~A
~062440~001~~May 3, 1983~No~DISCN~PHARMAFAIR INC
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTAK~AKORN~EQ 0.3% BASE~A~064163~
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTAMICIN SULFATE~AKORN~EQ 0.3% BA
SE~A~062635~001~AT~Jan 8, 1987~No~RX~AKORN INC
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTAMICIN SULFATE~ALCON PHARMS LTD
~EQ 0.3% BASE~A~062523~001~~Nov 25, 1985~No~DISCN~ALCON PHARMACEUTICALS LTD

GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTAMICIN SULFATE~ALCON RES LTD~EQ
0.3% BASE~A~062196~001~AT~Approved Prior to Jan 1, 1982~No~RX~ALCON RESEARCH LT
D
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTAMICIN SULFATE~BAUSCH AND LOMB~
EQ 0.3% BASE~A~064048~001~AT~May 11, 1994~Yes~RX~BAUSCH AND LOMB PHARMACEUTICALS
INC
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTAMICIN SULFATE~PACO~EQ 3MG BASE
/ML~A~062932~001~~Nov 7, 1988~No~DISCN~PACO RESEARCH CORP
GENTAMICIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~GENTAMICIN SULFATE~PERRIGO CO TENNE
SSEE~EQ 0.3% BASE~A~065121~001~AT~Jan 30, 2004~No~RX~PERRIGO CO TENNESSEE INC
IDOXURIDINE~SOLUTION/DROPS;OPHTHALMIC~HERPLEX~ALLERGAN~0.1%~N~013935~002~AT~Appr
oved Prior to Jan 1, 1982~Yes~RX~ALLERGAN PHARMACEUTICAL
DEMECARIUM BROMIDE~SOLUTION/DROPS;OPHTHALMIC~HUMORSOL~MERCK~0.125%~N~011860~002~
~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
DEMECARIUM BROMIDE~SOLUTION/DROPS;OPHTHALMIC~HUMORSOL~MERCK~0.25%~N~011860~001~~
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~INFLAMASE FORTE~NOVARTIS
~EQ 0.9% PHOSPHATE~A~080751~002~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS
PHARMACEUTICALS CORP
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~INFLAMASE MILD~NOVARTIS~
EQ 0.11% PHOSPHATE~A~080751~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS
PHARMACEUTICALS CORP
APRACLONIDINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~IOPIDINE~ALCON~EQ 0.5% BAS
E~N~020258~001~AT~Jul 30, 1993~Yes~RX~ALCON LABORATORIES INC
APRACLONIDINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~IOPIDINE~ALCON~EQ 1% BASE~
N~019779~001~~Dec 31, 1987~Yes~RX~ALCON LABORATORIES INC
LEVOFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~IQUIX~SANTEN~1.5% **Federal Register dete
reasons**~N~021571~001~~Mar 1, 2004~No~DISCN~SANTEN INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~ISOPTO CETAMIDE~ALCON~15%~A~08002
0~002~~Approved Prior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~ISTALOL~BAUSCH AND LOMB~EQ 0.5% BASE~N
~021516~001~BT~Jun 4, 2004~Yes~RX~BAUSCH AND LOMB INC
TRAVOPROST~SOLUTION/DROPS;OPHTHALMIC~IZBA~ALCON LABS INC~0.003%~N~204822~001~~Ma
y 15, 2014~Yes~RX~ALCON LABORATORIES INC
PROPARACAINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~KAINAIR~PHARMAFAIR~0.5%~A~0
88087~001~~Jun 7, 1983~No~DISCN~PHARMAFAIR INC
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~KETOROLAC TROMETHAMINE~AKORN~0.
4%~A~078399~001~AT~Nov 5, 2009~No~RX~AKORN INC
5%~A~078434~001~AT~Nov 5, 2009~No~RX~AKORN INC
45%~A~203376~001~~Feb 10, 2014~No~DISCN~AKORN INC
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~KETOROLAC TROMETHAMINE~ALCON PH
ARMS LTD~0.4%~A~078721~001~AT~Nov 5, 2009~No~RX~ALCON PHARMACEUTICALS LTD
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~KETOROLAC TROMETHAMINE~ALCON PH
ARMS LTD~0.5%~A~076583~001~AT~Nov 5, 2009~No~RX~ALCON PHARMACEUTICALS LTD
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~KETOROLAC TROMETHAMINE~APOTEX I
NC~0.4%~A~077308~001~AT~Nov 5, 2009~No~RX~APOTEX INC RICHMOND HILL
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~KETOROLAC TROMETHAMINE~APOTEX I
NC~0.5%~A~076109~001~AT~Nov 5, 2009~No~RX~APOTEX INC RICHMOND HILL
KETOROLAC TROMETHAMINE~SOLUTION/DROPS;OPHTHALMIC~KETOROLAC TROMETHAMINE~SUN PHAR
MA GLOBAL~0.5%~A~090017~001~AT~Nov 5, 2009~No~RX~SUN PHARMA GLOBAL INC
KETOTIFEN FUMARATE~SOLUTION/DROPS;OPHTHALMIC~KETOTIFEN FUMARATE~AKORN~EQ 0.025%
BASE~A~077958~001~~Jul 26, 2007~No~OTC~AKORN INC
KETOTIFEN FUMARATE~SOLUTION/DROPS;OPHTHALMIC~KETOTIFEN FUMARATE~ALCON PHARMS LTD
~EQ 0.025% BASE~A~077200~001~~Sep 2, 2008~No~OTC~ALCON PHARMACEUTICALS LTD
KETOTIFEN FUMARATE~SOLUTION/DROPS;OPHTHALMIC~KETOTIFEN FUMARATE~APOTEX INC~EQ 0.
025% BASE~A~077354~001~~May 9, 2006~No~DISCN~APOTEX INC
ALCAFTADINE~SOLUTION/DROPS;OPHTHALMIC~LASTACAFT~ALLERGAN~0.25%~N~022134~001~~Jul
28, 2010~Yes~RX~ALLERGAN INC
LATANOPROST~SOLUTION/DROPS;OPHTHALMIC~LATANOPROST~AKORN~0.005%~A~090887~001~AT~J
ul 19, 2011~No~RX~AKORN INC
LATANOPROST~SOLUTION/DROPS;OPHTHALMIC~LATANOPROST~ALCON RES~0.005%~A~091449~001~
AT~Mar 22, 2011~No~RX~ALCON RESEARCH LTD
LATANOPROST~SOLUTION/DROPS;OPHTHALMIC~LATANOPROST~APOTEX INC~0.005%~A~077697~001
~~Mar 22, 2011~No~DISCN~APOTEX INC
LATANOPROST~SOLUTION/DROPS;OPHTHALMIC~LATANOPROST~BAUSCH AND LOMB~0.005%~A~20100
6~001~AT~Mar 22, 2011~No~RX~BAUSCH AND LOMB INC
LATANOPROST~SOLUTION/DROPS;OPHTHALMIC~LATANOPROST~DR REDDYS LABS LTD~0.005%~A~20
2077~001~AT~Feb 11, 2013~No~RX~DR REDDYS LABORATORIES LTD
LATANOPROST~SOLUTION/DROPS;OPHTHALMIC~LATANOPROST~LUITPOLD~0.005%~A~200925~001~A
T~Mar 22, 2011~No~RX~LUITPOLD PHARMACEUTICALS INC
LATANOPROST~SOLUTION/DROPS;OPHTHALMIC~LATANOPROST~MYLAN~0.005%~A~201786~001~AT~M
ar 22, 2011~No~RX~MYLAN PHARMACEUTICALS INC
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~LEVOBUNOLOL HYDROCHLORIDE~AL
CON RES LTD~0.5%~A~074850~001~AT~Oct 28, 1996~No~RX~ALCON RESEARCH LTD
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~LEVOBUNOLOL HYDROCHLORIDE~AP
OTEX INC~0.25%~A~075473~001~~Aug 3, 2000~No~DISCN~APOTEX INC
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~LEVOBUNOLOL HYDROCHLORIDE~AP
OTEX INC~0.5%~A~075475~001~~Aug 3, 2000~No~DISCN~APOTEX INC
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~LEVOBUNOLOL HYDROCHLORIDE~BA
USCH AND LOMB~0.25%~A~074307~001~AT~Mar 4, 1994~No~RX~BAUSCH AND LOMB PHARMACEUT
ICALS INC
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~LEVOBUNOLOL HYDROCHLORIDE~BA
USCH AND LOMB~0.5%~A~074326~001~AT~Mar 4, 1994~No~RX~BAUSCH AND LOMB PHARMACEUTI
CALS INC
LEVOBUNOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~LEVOBUNOLOL HYDROCHLORIDE~FA
LCON PHARMS~0.25%~A~074851~001~AT~Oct 28, 1996~No~RX~FALCON PHARMACEUTICALS LTD
LEVOFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~LEVOFLOXACIN~AKORN~0.5%~A~090268~001~AT~D
ec 20, 2010~No~RX~AKORN INC
LEVOFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~LEVOFLOXACIN~APOTEX INC~0.5%~A~078282~001
~~Dec 20, 2010~No~DISCN~APOTEX INC
LEVOFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~LEVOFLOXACIN~NEXUS PHARMS~0.5%~A~077700~0
01~AT~Dec 20, 2010~No~RX~NEXUS PHARMACEUTICALS INC
LEVOFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~LEVOFLOXACIN~WATSON LABS INC~0.5%~A~07682
6~001~AT~Feb 10, 2011~No~RX~WATSON LABORATORIES INC
BIMATOPROST~SOLUTION/DROPS;OPHTHALMIC~LUMIGAN~ALLERGAN~0.01%~N~022184~001~~Aug 3
1, 2010~Yes~RX~ALLERGAN INC
BIMATOPROST~SOLUTION/DROPS;OPHTHALMIC~LUMIGAN~ALLERGAN~0.03% **Federal Register
determination that product was not discontinued or withdrawn for safety or effic
acy reasons**~N~021275~001~~Mar 16, 2001~No~DISCN~ALLERGAN INC
METIPRANOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~METIPRANOLOL~ALCON RES LTD~
0.3%~A~075720~001~AT~Aug 6, 2001~No~RX~ALCON RESEARCH LTD
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~METRETON~SCHERING~EQ 0.5
% PHOSPHATE~A~083834~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP S
UB SCHERING PLOUGH CORP
MOXIFLOXACIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~MOXEZA~ALCON PHARMS LTD~EQ
0.5% BASE~N~022428~001~~Nov 19, 2010~Yes~RX~ALCON PHARMACEUTICALS LTD
MOXIFLOXACIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~MOXIFLOXACIN HYDROCHLORIDE~
LUPIN LTD~EQ 0.5% BASE~A~202867~001~AT~Sep 4, 2014~No~RX~LUPIN LTD
MOXIFLOXACIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~MOXIFLOXACIN HYDROCHLORIDE~
WATSON LABS INC~EQ 0.5% BASE~A~202525~001~AT~Mar 6, 2015~No~RX~WATSON LABORATORI
ES INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~MYDRIACYL~ALCON~0.5%~A~084305~001~AT~Appro
ved Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~MYDRIACYL~ALCON~0.5%~N~012111~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~MYDRIACYL~ALCON~1%~A~084306~001~AT~Approve
d Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC

TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~MYDRIACYL~ALCON~1%~N~012111~004~~Approved
Prior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~MYDRIAFAIR~PHARMAFAIR~0.5%~A~088274~001~~S
ep 16, 1983~No~DISCN~PHARMAFAIR INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~MYDRIAFAIR~PHARMAFAIR~1%~A~088230~001~~Sep
NAPHAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~NAFAZAIR~BAUSCH AND LOMB~0.1
%~A~040073~001~~May 25, 1994~No~DISCN~BAUSCH AND LOMB PHARMACEUTICALS INC
NAPHAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~NAFAZAIR~PHARMAFAIR~0.1%~A~0
88101~001~~Apr 15, 1983~No~DISCN~PHARMAFAIR INC
NAPHAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~NAPHAZOLINE HYDROCHLORIDE~AK
ORN INC~0.1%~A~083590~001~~Approved Prior to Jan 1, 1982~Yes~RX~AKORN INC
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE~SOLUTION/DROPS;OPHTHALMIC~NAPHAZO
LINE HYDROCHLORIDE AND PHENIRAMINE MALEATE~AKORN INC~0.025%;0.3%~A~202795~001~~J
an 24, 2013~No~OTC~AKORN INC
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE~SOLUTION/DROPS;OPHTHALMIC~NAPHAZO
LINE HYDROCHLORIDE AND PHENIRAMINE MALEATE~ALTAIRE PHARMS INC~0.02675%;0.315%~A~
078208~001~~Sep 27, 2010~No~OTC~ALTAIRE PHARMACEUTICALS INC
NAPHAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~NAPHCON FORTE~ALCON~0.1%~A~0
80229~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE~SOLUTION/DROPS;OPHTHALMIC~NAPHCON
-A~ALCON~0.025%;0.3%~N~020226~001~~Jun 8, 1994~Yes~OTC~ALCON LABORATORIES INC
NEDOCROMIL SODIUM~SOLUTION/DROPS;OPHTHALMIC~NEDOCROMIL SODIUM~AKORN~2%~A~090638~
001~AT~Aug 22, 2012~No~RX~AKORN INC
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OPHTHALMIC~NEOPOLYCIN~DOW PHARM~0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML~A~060427~001~~App
roved Prior to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL CORP SUB DOW CHEMICAL CO
DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~NEODE
CADRON~MERCK~EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML~N~050322~001~~Approved Prior to
Jan 1, 1982~No~DISCN~MERCK AND CO INC
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OPHTHALMIC~NEOM
YCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN~BAUSCH AND LOMB~0.025MG/ML;EQ 1.75M
G BASE/ML;10,000 UNITS/ML~A~064047~001~AT~Jan 31, 1996~Yes~RX~BAUSCH AND LOMB PH
ARMACEUTICALS INC
YCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN~IPHARM~0.025MG/ML;EQ 1.75MG BASE/ML
;10,000 UNITS/ML~A~062818~001~~Oct 11, 1988~No~DISCN~IPHARM DIV LYPHOMED INC
YCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN~LUITPOLD~0.025MG/ML;EQ 1.75MG BASE/
ML;10,000 UNITS/ML~A~065187~001~AT~Oct 28, 2005~No~RX~LUITPOLD PHARMACEUTICALS I
NC
YCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN~WATSON LABS~0.025MG/ML;EQ 1.75MG BA
SE/ML;10,000 UNITS/ML~A~062788~001~~Jun 11, 1987~No~DISCN~WATSON LABORATORIES IN
C
DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE~SOLUTION/DROPS;OPHTHALMIC~NEOMY
CIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE~BAUSCH AND LOMB~EQ 0.1% PHOSPHATE
;EQ 3.5MG BASE/ML~A~064055~001~~Oct 30, 1995~No~DISCN~BAUSCH AND LOMB PHARMACEUT
ICALS INC
YCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN~PHARMAFAIR~0.025MG/ML;EQ 1.75MG
BASE/ML;10,000 UNITS/ML~A~062383~001~~Aug 31, 1982~No~DISCN~PHARMAFAIR INC
CIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE~ALCON PHARMS LTD~EQ 0.1% PHOSPHATE;EQ
3.5MG BASE/ML~A~062714~001~~Jul 21, 1986~No~DISCN~ALCON PHARMACEUTICALS LTD
CIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE~PHARMAFAIR~EQ 0.1% PHOSPHATE;EQ 3.5MG
BASE/ML~A~062539~001~~Jan 10, 1985~No~DISCN~PHARMAFAIR INC
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OPHTHALMIC~NEOS
PORIN~MONARCH PHARMS~0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML~A~060582~001~A

T~Approved Prior to Jan 1, 1982~Yes~RX~MONARCH PHARMACEUTICALS INC
OXYMETAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~OCUCLEAR~SCHERING PLOUGH~0
.025%~N~018471~001~~May 30, 1986~No~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
FLURBIPROFEN SODIUM~SOLUTION/DROPS;OPHTHALMIC~OCUFEN~ALLERGAN~0.03%~N~019404~001
~AT~Dec 31, 1986~Yes~RX~ALLERGAN PHARMACEUTICAL
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OCUFLOX~ALLERGAN~0.3%~N~019921~001~AT~Jul 30
, 1993~Yes~RX~ALLERGAN INC
CARTEOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~OCUPRESS~NOVARTIS~1%~N~019972~
001~AT~May 23, 1990~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~OCUSULF-10~MIZA PHARMS USA~10%~A~
080660~001~~Approved Prior to Jan 1, 1982~No~DISCN~MIZA PHARMACEUTICALS USA INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~OCUSULF-30~MIZA PHARMS USA~30%~A~
080660~002~~Approved Prior to Jan 1, 1982~No~DISCN~MIZA PHARMACEUTICALS USA INC
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~AKORN~0.3%~A~076407~001~AT~Apr 15,
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~ALCON PHARMS LTD~0.3%~A~076231~001
~AT~May 14, 2004~No~RX~ALCON PHARMACEUTICALS LTD
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~ALTAIRE PHARMS INC~0.3%~A~202692~0
01~AT~Apr 29, 2013~No~RX~ALTAIRE PHARMACEUTICALS INC
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~APOTEX INC~0.3%~A~076513~001~~May
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~BAUSCH AND LOMB~0.3%~A~076622~001~
AT~May 14, 2004~No~RX~BAUSCH AND LOMB INC
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~FDC LTD~0.3%~A~078559~001~AT~Feb 2
5, 2009~No~RX~FDC LTD
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~FERA PHARMS~0.3%~A~076830~001~AT~A
ug 31, 2004~No~RX~FERA PHARMACEUTICALS LLC
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~HI TECH PHARMA~0.3%~A~076615~001~A
T~May 14, 2004~No~RX~HI TECH PHARMACAL CO INC
OFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~OFLOXACIN~SANDOZ~0.3%~A~076848~001~~Nov 25,
2008~No~DISCN~SANDOZ
NAPHAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~OPCON~BAUSCH AND LOMB~0.1%~A
~087506~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAUSCH AND LOMB PHARMACEUTIC
ALS INC
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE~SOLUTION/DROPS;OPHTHALMIC~OPCON-A
~BAUSCH AND LOMB~0.02675%;0.315%~N~020065~001~~Jun 8, 1994~Yes~OTC~BAUSCH AND LO
MB INC
PROPARACAINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~OPHTHAINE~APOTHECON~0.5%~N~
008883~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYE
RS SQUIBB
PROPARACAINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~OPHTHETIC~ALLERGAN~0.5%~N~0
12583~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTICAL
CHLORAMPHENICOL~SOLUTION/DROPS;OPHTHALMIC~OPHTHOCHLOR~PARKEDALE~0.5%~A~061220~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
CROMOLYN SODIUM~SOLUTION/DROPS;OPHTHALMIC~OPTICROM~ALLERGAN~4%~N~018155~001~~Oct
3, 1984~No~DISCN~ALLERGAN INC
METIPRANOLOL HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~OPTIPRANOLOL~BAUSCH AND LOM
B~0.3%~N~019907~001~AT~Dec 29, 1989~Yes~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
AZELASTINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~OPTIVAR~MEDA PHARMS~0.05%~N~0
21127~001~AT~May 22, 2000~Yes~RX~MEDA PHARMACEUTICALS INC
CHLORAMPHENICOL~SOLUTION/DROPS;OPHTHALMIC~OPTOMYCIN~OPTOPICS~0.5%~A~062171~001~~
Mar 31, 1982~No~DISCN~OPTOPICS LABORATORIES CORP
PROPARACAINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PARACAINE~OPTOPICS~0.5%~A~0
87681~001~~Aug 5, 1982~No~DISCN~OPTOPICS LABORATORIES CORP
HYDROXYAMPHETAMINE HYDROBROMIDE~SOLUTION/DROPS;OPHTHALMIC~PAREDRINE~PHARMICS~1%~
N~000004~004~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMICS INC
HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~PAREMYD~A
KORN~1%;0.25%~N~019261~001~~Jan 30, 1992~Yes~RX~AKORN INC
OLOPATADINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PATADAY~ALCON PHARMS LTD~EQ
0.2% BASE~N~021545~001~~Dec 22, 2004~Yes~RX~ALCON PHARMACEUTICALS LTD

OLOPATADINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PATANOL~ALCON~EQ 0.1% BASE~N
~020688~001~~Dec 18, 1996~Yes~RX~ALCON LABORATORIES INC
OLOPATADINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PAZEO~ALCON RES LTD~EQ 0.7%
BASE~N~206276~001~~Jan 30, 2015~Yes~RX~ALCON RESEARCH LTD
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PENTOLAIR~BAUSCH AND LOMB
~1%~A~040075~001~AT~Apr 29, 1994~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PENTOLAIR~PHARMAFAIR~0.5%
~A~088643~001~~Feb 9, 1987~No~DISCN~PHARMAFAIR INC
CYCLOPENTOLATE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PENTOLAIR~PHARMAFAIR~1%~A
~088150~001~~Feb 25, 1983~No~DISCN~PHARMAFAIR INC
PHENYLEPHRINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PHENYLEPHRINE HYDROCHLORID
E~AKORN INC~2.5%~N~207926~001~~Jan 15, 2015~No~RX~AKORN INC
E~AKORN INC~10%~N~207926~002~~Jan 15, 2015~No~RX~AKORN INC
E~PARAGON BIOTECK~2.5%~N~203510~001~~Mar 21, 2013~No~RX~PARAGON BIOTECK INC
E~PARAGON BIOTECK~10%~N~203510~002~~Mar 21, 2013~Yes~RX~PARAGON BIOTECK INC
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE~SOLUTION/DROPS;OPHTHALMIC~POLYTRIM~ALL
ERGAN~10,000 UNITS/ML;EQ 1MG BASE/ML~N~050567~001~AT~Oct 20, 1988~Yes~RX~ALLERGA
N INC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~PREDAIR~PHARMAFAIR~EQ 0.
11% PHOSPHATE~A~088415~001~~Feb 29, 1984~No~DISCN~PHARMAFAIR INC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~PREDAIR FORTE~PHARMAFAIR
~EQ 0.9% PHOSPHATE~A~088165~001~~Mar 28, 1983~No~DISCN~PHARMAFAIR INC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC~PREDNISOLONE SODIUM PHOS
PHATE~AKORN~EQ 0.11% PHOSPHATE~A~083358~001~~Approved Prior to Jan 1, 1982~No~DI
SCN~AKORN INC
PHATE~AKORN~EQ 0.9% PHOSPHATE~A~083358~002~~Approved Prior to Jan 1, 1982~No~DIS
CN~AKORN INC
PHATE~ALCON PHARMS LTD~EQ 0.11% PHOSPHATE~A~081043~001~~Oct 24, 1991~No~DISCN~AL
CON PHARMACEUTICALS LTD
PHATE~ALCON PHARMS LTD~EQ 0.9% PHOSPHATE~A~081044~001~~Oct 24, 1991~No~DISCN~ALC
ON PHARMACEUTICALS LTD
PHATE~BAUSCH AND LOMB~EQ 0.11% PHOSPHATE~A~040065~001~~Jul 29, 1994~No~DISCN~BAU
SCH AND LOMB PHARMACEUTICALS INC
PHATE~BAUSCH AND LOMB~EQ 0.9% PHOSPHATE~A~040070~001~~Jul 29, 1994~Yes~RX~BAUSCH
AND LOMB PHARMACEUTICALS INC
PHATE~SOLA BARNES HIND~EQ 0.11% PHOSPHATE~A~084171~001~~Approved Prior to Jan 1,
1982~No~DISCN~SOLA BARNES HIND
PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE~SOLUTION/DROPS;OPHTHALMIC~PREFRI
N-A~ALLERGAN~0.12%;0.1%~N~007953~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALL
ERGAN PHARMACEUTICAL
SUPROFEN~SOLUTION/DROPS;OPHTHALMIC~PROFENAL~ALCON~1%~N~019387~001~~Dec 23, 1988~
No~DISCN~ALCON LABORATORIES INC

BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~PROLENSA~BAUSCH AND LOMB~EQ 0.07% ACI
D~N~203168~001~~Apr 5, 2013~Yes~RX~BAUSCH AND LOMB INC
PROPARACAINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PROPARACAINE HYDROCHLORIDE~
AKORN INC~0.5%~A~040277~001~AT~Mar 16, 2000~No~RX~AKORN INC
BAUSCH AND LOMB~0.5%~A~040074~001~AT~Sep 29, 1995~No~RX~BAUSCH AND LOMB PHARMACE
UTICALS INC
SOLA BARNES HIND~0.5%~A~084144~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLA
BARNES HIND
SOLA BARNES HIND~0.5%~A~084151~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLA
BARNES HIND
DIPIVEFRIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~PROPINE~ALLERGAN~0.1%~N~01823
9~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTICAL
BRIMONIDINE TARTRATE~SOLUTION/DROPS;OPHTHALMIC~QOLIANA~ALCON PHARMS LTD~0.15%~N~
021764~001~AT~May 22, 2006~No~RX~ALCON PHARMACEUTICALS LTD
LEVOFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~QUIXIN~SANTEN~0.5%~N~021199~001~AT~Aug 18
, 2000~Yes~RX~SANTEN INC
UNOPROSTONE ISOPROPYL~SOLUTION/DROPS;OPHTHALMIC~RESCULA~SUCAMPO PHARMA LLC~0.15%
~N~021214~001~~Aug 3, 2000~Yes~RX~SUCAMPO PHARMA AMERICAS LLC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SODIUM SULAMYD~SCHERING~10%~N~005
H CORP
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SODIUM SULAMYD~SCHERING~30%~N~005
H CORP
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SODIUM SULFACETAMIDE~AKORN~10%~A~
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SODIUM SULFACETAMIDE~SOLA BARNES
HIND~10%~A~084143~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLA BARNES HIND
NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OPHTHALMIC~STATROL~ALCON~EQ
3.5MG BASE/ML;16,250 UNITS/ML~A~062339~001~~Nov 30, 1984~No~DISCN~ALCON LABORAT
ORIES INC
NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OPHTHALMIC~STATROL~ALCON~EQ
3.5MG BASE/ML;16,250 UNITS/ML~N~050456~001~~Approved Prior to Jan 1, 1982~No~DI
SCN~ALCON LABORATORIES INC
IDOXURIDINE~SOLUTION/DROPS;OPHTHALMIC~STOXIL~GLAXOSMITHKLINE~0.1%~N~013934~001~~
Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULF-10~NOVARTIS~10%~A~080025~001
~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULF-15~NOVARTIS~15%~A~089047~001
~~Oct 31, 1995~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFACEL-15~OPTOPICS~15%~A~080024
~001~~Approved Prior to Jan 1, 1982~No~DISCN~OPTOPICS LABORATORIES CORP
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFACETAMIDE SODIUM~AKORN~10%~A~
040215~001~~May 25, 1999~No~DISCN~AKORN INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFACETAMIDE SODIUM~AKORN~30%~A~
040216~001~~May 25, 1999~No~DISCN~AKORN INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFACETAMIDE SODIUM~ALCON PHARMS

LTD~10%~A~089560~001~AT~Oct 18, 1988~No~RX~ALCON PHARMACEUTICALS LTD
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFACETAMIDE SODIUM~ALCON PHARMS
LTD~30%~A~089068~001~~May 5, 1987~No~DISCN~ALCON PHARMACEUTICALS LTD
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFACETAMIDE SODIUM~BAUSCH AND L
OMB~10%~A~040066~001~AT~Dec 28, 1994~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFACETAMIDE SODIUM~PHARMAFAIR~1
0%~A~088947~001~~May 17, 1985~No~DISCN~PHARMAFAIR INC
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SU
LFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE~ALCON PHARMS LTD~EQ 0.23% P
HOSPHATE;10%~A~073630~001~AT~May 27, 1993~No~RX~ALCON PHARMACEUTICALS LTD
LFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE~BAUSCH AND LOMB~EQ 0.23% PH
OSPHATE;10%~A~074449~001~AT~Dec 29, 1995~Yes~RX~BAUSCH AND LOMB PHARMACEUTICALS
INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFAIR 10~PHARMAFAIR~10%~A~08794
9~001~~Dec 13, 1982~No~DISCN~PHARMAFAIR INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFAIR FORTE~PHARMAFAIR~30%~A~08
8385~001~~Oct 13, 1983~No~DISCN~PHARMAFAIR INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULFAIR-15~PHARMAFAIR~15%~A~08818
6~001~~May 25, 1983~No~DISCN~PHARMAFAIR INC
SULFISOXAZOLE DIOLAMINE~SOLUTION/DROPS;OPHTHALMIC~SULFISOXAZOLE DIOLAMINE~SOLA B
ARNES HIND~EQ 4% BASE~A~084148~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLA
BARNES HIND
LSTER~AKORN~EQ 0.23% PHOSPHATE;10%~A~074511~001~~Jul 30, 1996~No~DISCN~AKORN INC
SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~SULTEN-10~BAUSCH AND LOMB~10%~A~0
87818~001~~Feb 3, 1983~No~DISCN~BAUSCH AND LOMB INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~AKORN~EQ 0.25% BASE~A~
074465~001~~Mar 25, 1997~No~DISCN~AKORN INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~AKORN~EQ 0.25% BASE~A~
074515~001~~Mar 25, 1997~No~DISCN~AKORN INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~AKORN~EQ 0.5% BASE~A~0
74466~001~AT~Mar 25, 1997~No~RX~AKORN INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~AKORN~EQ 0.5% BASE~A~0
74516~001~AT~Mar 25, 1997~No~RX~AKORN INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~ALCON RES LTD~EQ 0.25%
BASE~A~074261~001~AT~Apr 28, 1995~No~RX~ALCON RESEARCH LTD
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~ALCON RES LTD~EQ 0.5%
BASE~A~074262~001~AT~Apr 28, 1995~No~RX~ALCON RESEARCH LTD
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~APOTEX INC~EQ 0.25% BA
SE~A~075411~001~~Sep 8, 2000~No~DISCN~APOTEX INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~APOTEX INC~EQ 0.5% BAS
E~A~075412~001~~Sep 8, 2000~No~DISCN~APOTEX INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~BAUSCH AND LOMB~EQ 0.2
5% BASE~A~074778~001~AT~Mar 25, 1997~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~BAUSCH AND LOMB~EQ 0.5
% BASE~A~074776~001~AT~Mar 25, 1997~No~RX~BAUSCH AND LOMB INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~FDC LTD~EQ 0.25% BASE~
A~077259~001~AT~Apr 30, 2008~No~RX~FDC LTD
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~FDC LTD~EQ 0.5% BASE~A
~077259~002~AT~Apr 30, 2008~No~RX~FDC LTD
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~FOUGERA~EQ 0.25% BASE~
A~074667~001~~Mar 25, 1997~No~DISCN~E FOUGERA DIV ALTANA INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~FOUGERA~EQ 0.5% BASE~A
~074668~001~~Mar 25, 1997~No~DISCN~E FOUGERA DIV ALTANA INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~HI TECH PHARMA~EQ 0.5%
BASE~A~075163~001~AT~Sep 10, 2002~No~RX~HI TECH PHARMACAL CO INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~PACIFIC PHARMA~EQ 0.25
% BASE~A~074746~001~AT~Mar 25, 1997~No~RX~PACIFIC PHARMA INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~PACIFIC PHARMA~EQ 0.5%

BASE~A~074747~001~AT~Mar 25, 1997~No~RX~PACIFIC PHARMA
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~WOCKHARDT~EQ 0.25% BAS
E~A~078771~001~AT~Sep 28, 2009~No~RX~WOCKHARDT LTD
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOLOL MALEATE~WOCKHARDT~EQ 0.5% BASE
~A~078771~002~AT~Sep 28, 2009~No~RX~WOCKHARDT LTD
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOPTIC~ATON~EQ 0.25% BASE~N~018086~0
01~AT~Approved Prior to Jan 1, 1982~Yes~RX~ATON PHARMA INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOPTIC~ATON~EQ 0.5% BASE~N~018086~00
2~AT~Approved Prior to Jan 1, 1982~Yes~RX~ATON PHARMA INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOPTIC IN OCUDOSE~ATON~EQ 0.25% BASE
~N~019463~001~~Nov 5, 1986~Yes~RX~ATON PHARMA INC
TIMOLOL MALEATE~SOLUTION/DROPS;OPHTHALMIC~TIMOPTIC IN OCUDOSE~ATON~EQ 0.5% BASE~
N~019463~002~~Nov 5, 1986~Yes~RX~ATON PHARMA INC
TOBRAMYCIN~SOLUTION/DROPS;OPHTHALMIC~TOBRAMYCIN~ALCON PHARMS LTD~0.3%~A~063176~0
01~~May 25, 1994~No~DISCN~ALCON PHARMACEUTICALS LTD
TOBRAMYCIN~SOLUTION/DROPS;OPHTHALMIC~TOBRAMYCIN~APOTEX INC~0.3%~A~065087~001~~Fe
b 25, 2002~No~DISCN~APOTEX INC
TOBRAMYCIN~SOLUTION/DROPS;OPHTHALMIC~TOBRAMYCIN~BAUSCH AND LOMB~0.3%~A~064052~00
1~AT~Nov 29, 1993~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
TOBRAMYCIN~SOLUTION/DROPS;OPHTHALMIC~TOBRAMYCIN~FERA PHARMS~0.3%~A~065026~001~AT
~Sep 11, 2001~No~RX~FERA PHARMACEUTICALS LLC
TOBRAMYCIN~SOLUTION/DROPS;OPHTHALMIC~TOBREX~ALCON~0.3%~A~062535~001~AT~Dec 13, 1
984~No~RX~ALCON LABORATORIES INC
TOBRAMYCIN~SOLUTION/DROPS;OPHTHALMIC~TOBREX~FALCON PHARMS~0.3%~N~050541~001~AT~A
pproved Prior to Jan 1, 1982~Yes~RX~FALCON PHARMACEUTICALS LTD
TRAVOPROST~SOLUTION/DROPS;OPHTHALMIC~TRAVATAN~ALCON PHARMS LTD~0.004%~N~021257~0
01~~Mar 16, 2001~No~DISCN~ALCON PHARMACEUTICALS LTD
TRAVOPROST~SOLUTION/DROPS;OPHTHALMIC~TRAVATAN Z~ALCON PHARMS LTD~0.004%~N~021994
~001~~Sep 21, 2006~Yes~RX~ALCON PHARMACEUTICALS LTD
TRAVOPROST~SOLUTION/DROPS;OPHTHALMIC~TRAVOPROST~PAR PHARM~0.004%~A~091340~001~~M
ar 1, 2013~Yes~RX~PAR PHARMACEUTICAL INC
TRIFLURIDINE~SOLUTION/DROPS;OPHTHALMIC~TRIFLURIDINE~ALCON PHARMS LTD~1%~A~074311
~001~AT~Oct 6, 1995~No~RX~ALCON PHARMACEUTICALS LTD
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE~SOLUTION/DROPS;OPHTHALMIC~TRIMETHOPRIM
SULFATE AND POLYMYXIN B SULFATE~AKORN INC~10,000 UNITS/ML;EQ 1MG BASE/ML~A~0650
06~001~AT~Dec 17, 1998~No~RX~AKORN INC
SULFATE AND POLYMYXIN B SULFATE~ALCON RES LTD~10,000 UNITS/ML;EQ 1MG BASE/ML~A~
064211~001~AT~Apr 13, 1998~No~RX~ALCON RESEARCH LTD
SULFATE AND POLYMYXIN B SULFATE~BAUSCH AND LOMB~10,000 UNITS/ML;EQ 1MG BASE/ML~
A~064120~001~AT~Feb 14, 1997~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICACYL~AKORN~0.5%~A~040314~001~AT~Sep
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICACYL~AKORN~1%~A~040315~001~AT~Sep 29
, 2000~No~RX~AKORN INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICAMIDE~AKORN~1%~A~088447~001~~Aug 28,
1985~No~DISCN~AKORN INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICAMIDE~ALCON PHARMS LTD~1%~A~089172~0
01~~Dec 28, 1990~No~DISCN~ALCON PHARMACEUTICALS LTD
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICAMIDE~BAUSCH AND LOMB~0.5%~A~040067~
001~AT~Jul 27, 1994~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICAMIDE~BAUSCH AND LOMB~1%~A~040064~00
1~AT~Jul 27, 1994~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICAMIDE~MIZA PHARMS USA~0.5%~A~087636~
001~~Jul 30, 1982~No~DISCN~MIZA PHARMACEUTICALS USA INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICAMIDE~MIZA PHARMS USA~1%~A~087637~00
1~~Aug 9, 1982~No~DISCN~MIZA PHARMACEUTICALS USA INC
TROPICAMIDE~SOLUTION/DROPS;OPHTHALMIC~TROPICAMIDE~WATSON LABS~0.5%~A~089171~001~
~Dec 28, 1990~No~DISCN~WATSON LABORATORIES INC

DORZOLAMIDE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~TRUSOPT~MERCK~EQ 2% BASE~N~0
20408~001~AT~Dec 9, 1994~Yes~RX~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM~SOLUTION/DROPS;OPHTHALMIC~VA
SOCIDIN~NOVARTIS~EQ 0.23% PHOSPHATE;10%~N~018988~001~~Aug 26, 1988~No~DISCN~NOVA
RTIS PHARMACEUTICALS CORP
NAPHAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~VASOCON~NOVARTIS~0.1%~A~0802
35~002~~Mar 24, 1983~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~VASOCO
N-A~NOVARTIS~0.5%;0.05%~N~018746~002~~Jul 11, 1994~No~DISCN~NOVARTIS PHARMACEUTI
CALS CORP
MOXIFLOXACIN HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~VIGAMOX~ALCON PHARMS LTD~EQ
0.5% BASE~N~021598~001~AT~Apr 15, 2003~Yes~RX~ALCON PHARMACEUTICALS LTD
TRIFLURIDINE~SOLUTION/DROPS;OPHTHALMIC~VIROPTIC~MONARCH PHARMS~1%~N~018299~001~A
T~Approved Prior to Jan 1, 1982~Yes~RX~MONARCH PHARMACEUTICALS INC
OXYMETAZOLINE HYDROCHLORIDE~SOLUTION/DROPS;OPHTHALMIC~VISINE L.R.~JOHNSON AND JO
HNSON~0.025%~N~019407~001~~Mar 31, 1989~Yes~OTC~JOHNSON AND JOHNSON HEALTHCARE P
RODUCTS
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE~SOLUTION/DROPS;OPHTHALMIC~VISINEA~JOHNSON AND JOHNSON~0.025%;0.3%~N~020485~001~~Jan 31, 1996~Yes~OTC~JOHNSON AND
JOHNSON GROUP CONSUMER COMPANIES
DICLOFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~VOLTAREN~NOVARTIS~0.1%~N~020037~001~
AT~Mar 28, 1991~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
LATANOPROST~SOLUTION/DROPS;OPHTHALMIC~XALATAN~PHARMACIA AND UPJOHN~0.005%~N~0205
97~001~AT~Jun 5, 1996~Yes~RX~PHARMACIA AND UPJOHN CO
BROMFENAC SODIUM~SOLUTION/DROPS;OPHTHALMIC~XIBROM~BAUSCH AND LOMB INC~EQ 0.09% A
CID~N~021664~001~~Mar 24, 2005~No~DISCN~BAUSCH AND LOMB INC
KETOTIFEN FUMARATE~SOLUTION/DROPS;OPHTHALMIC~ZADITOR~ALCON PHARMA~EQ 0.025% BASE
~N~021066~002~~Oct 19, 2006~Yes~OTC~ALCON RESEARCH LTD
TAFLUPROST~SOLUTION/DROPS;OPHTHALMIC~ZIOPTAN~OAK PHARMS INC~0.0015%~N~202514~001
~~Feb 10, 2012~Yes~RX~OAK PHARMACEUTICALS INC
GATIFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~ZYMAR~ALLERGAN~0.3%~N~021493~001~~Mar 28,
GATIFLOXACIN~SOLUTION/DROPS;OPHTHALMIC~ZYMAXID~ALLERGAN~0.5%~N~022548~001~AT~May
18, 2010~Yes~RX~ALLERGAN
DEXAMETHASONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC, OTIC~DECADRON~MERCK~EQ
0.1% PHOSPHATE~N~011984~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND C
O INC
DEXAMETHASONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC, OTIC~DEXAMETHASONE SOD
IUM PHOSPHATE~ALCON PHARMS LTD~EQ 0.1% PHOSPHATE~A~088771~001~AT~Jan 16, 1985~Ye
s~RX~ALCON PHARMACEUTICALS LTD
DEXAMETHASONE SODIUM PHOSPHATE~SOLUTION/DROPS;OPHTHALMIC, OTIC~DEXAMETHASONE SOD
IUM PHOSPHATE~BAUSCH AND LOMB~EQ 0.1% PHOSPHATE~A~040069~001~AT~Jul 26, 1996~No~
RX~BAUSCH AND LOMB PHARMACEUTICALS INC
ACETIC ACID, GLACIAL~SOLUTION/DROPS;OTIC~ACETASOL~ACTAVIS MID ATLANTIC~2%~A~0871
46~001~~Approved Prior to Jan 1, 1982~No~DISCN~ACTAVIS MID ATLANTIC LLC
ACETIC ACID, GLACIAL; HYDROCORTISONE~SOLUTION/DROPS;OTIC~ACETASOL HC~ACTAVIS MID
ATLANTIC~2%;1%~A~087143~001~AT~Jan 13, 1982~No~RX~ACTAVIS MID ATLANTIC LLC
ACETIC ACID, GLACIAL~SOLUTION/DROPS;OTIC~ACETIC ACID~KV PHARM~2%~A~085493~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
ACETIC ACID, GLACIAL~SOLUTION/DROPS;OTIC~ACETIC ACID~TARO~2%~A~088638~001~AT~Sep
6, 1984~No~RX~TARO PHARMACEUTICALS USA INC
ACETIC ACID, GLACIAL~SOLUTION/DROPS;OTIC~ACETIC ACID~VINTAGE~2%~A~040607~001~AT~
Feb 24, 2005~No~RX~VINTAGE PHARMACEUTICALS LLC
ACETIC ACID, GLACIAL~SOLUTION/DROPS;OTIC~ACETIC ACID~WOCKHARDT~2%~A~040166~001~A
T~Jul 26, 1996~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
ACETIC ACID, GLACIAL; ALUMINUM ACETATE~SOLUTION/DROPS;OTIC~ACETIC ACID 2% IN AQU
EOUS ALUMINUM ACETATE~BAUSCH AND LOMB~2%;0.79%~A~040063~001~~Feb 25, 1994~Yes~RX
~BAUSCH AND LOMB PHARMACEUTICALS INC
ACETIC ACID, GLACIAL; HYDROCORTISONE~SOLUTION/DROPS;OTIC~ACETIC ACID W/ HYDROCOR
TISONE~KV PHARM~2%;1%~A~085492~001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PH

ARMACEUTICAL CO
ACETIC ACID, GLACIAL; ALUMINUM ACETATE~SOLUTION/DROPS;OTIC~BOROFAIR~PHARMAFAIR~2
%;0.79%~A~088606~001~~Aug 21, 1985~No~DISCN~PHARMAFAIR INC
TROLAMINE POLYPEPTIDE OLEATE CONDENSATE~SOLUTION/DROPS;OTIC~CERUMENEX~PHARM RES
ASSOC~10%~N~011340~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RE
SEARCH ASSOC INC
CIPROFLOXACIN HYDROCHLORIDE~SOLUTION/DROPS;OTIC~CETRAXAL~WRASER PHARMS~EQ 0.2% B
ASE~N~021918~001~~May 1, 2009~Yes~RX~WRASER PHARMACEUTICALS LLC
CHLORAMPHENICOL~SOLUTION/DROPS;OTIC~CHLOROMYCETIN~PARKEDALE~0.5%~N~050205~001~~A
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OTIC~CORTIS
PORIN~MONARCH PHARMS~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~N~050479~001~AT~Approve
d Prior to Jan 1, 1982~Yes~RX~MONARCH PHARMACEUTICALS INC
DEXAMETHASONE SODIUM PHOSPHATE~SOLUTION/DROPS;OTIC~DEXAMETHASONE SODIUM PHOSPHAT
E~AKORN~EQ 0.1% PHOSPHATE~A~084855~001~~Approved Prior to Jan 1, 1982~No~DISCN~A
KORN INC
ACETIC ACID, GLACIAL; ALUMINUM ACETATE~SOLUTION/DROPS;OTIC~DOMEBORO~BAYER PHARMS
~2%;0.79%~A~084476~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTI
CALS CORP
OFLOXACIN~SOLUTION/DROPS;OTIC~FLOXIN OTIC~DAIICHI~0.3%~N~020799~001~AT~Dec 16, 1
997~Yes~RX~DAIICHI PHARMACEUTICAL CORP
ACETIC ACID, GLACIAL; HYDROCORTISONE~SOLUTION/DROPS;OTIC~HYDROCORTISONE AND ACET
IC ACID~BAUSCH AND LOMB~2%;1%~A~040097~001~~Oct 31, 1994~No~DISCN~BAUSCH AND LOM
B PHARMACEUTICALS INC
IC ACID~TARO~2%;1%~A~088759~001~AT~Mar 4, 1985~No~RX~TARO PHARMACEUTICALS USA IN
C
IC ACID~VINTAGE~2%;1%~A~040609~001~AT~Feb 6, 2006~No~RX~VINTAGE PHARMACEUTICALS
LLC
IC ACID~WOCKHARDT~2%;1%~A~040168~001~~Aug 30, 1996~No~DISCN~WOCKHARDT EU OPERATI
ONS (SWISS) AG
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OTIC~NEOMYC
IN AND POLYMYXIN B SULFATES AND HYDROCORTISONE~ALCON PHARMS LTD~1%;EQ 3.5MG BASE
/ML;10,000 UNITS/ML~A~062423~001~AT~Aug 25, 1983~No~RX~ALCON PHARMACEUTICALS LTD
IN AND POLYMYXIN B SULFATES AND HYDROCORTISONE~BAUSCH AND LOMB~1%;EQ 3.5MG BASE/
ML;10,000 UNITS/ML~A~064053~001~AT~Dec 29, 1995~No~RX~BAUSCH AND LOMB PHARMACEUT
ICALS INC
IN AND POLYMYXIN B SULFATES AND HYDROCORTISONE~LUITPOLD~1%;EQ 3.5MG BASE/ML;10,0
00 UNITS/ML~A~065216~001~AT~Oct 31, 2005~No~RX~LUITPOLD PHARMACEUTICALS INC
IN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE~PHARMAFAIR~1%;EQ 3.5MG BASE/ML;10,
000 UNITS/ML~A~062394~001~~Sep 29, 1982~No~DISCN~PHARMAFAIR INC
OFLOXACIN~SOLUTION/DROPS;OTIC~OFLOXACIN~ALCON PHARMS LTD~0.3%~A~078222~001~AT~Ma
r 17, 2008~No~RX~ALCON PHARMACEUTICALS LTD
OFLOXACIN~SOLUTION/DROPS;OTIC~OFLOXACIN~APOTEX INC~0.3%~A~076527~001~AT~Sep 28,
OFLOXACIN~SOLUTION/DROPS;OTIC~OFLOXACIN~BAUSCH AND LOMB~0.3%~A~076128~001~AT~Mar
17, 2008~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
OFLOXACIN~SOLUTION/DROPS;OTIC~OFLOXACIN~FERA PHARMS~0.3%~A~090395~001~AT~Aug 11,
2009~No~RX~FERA PHARMACEUTICALS LLC
OFLOXACIN~SOLUTION/DROPS;OTIC~OFLOXACIN~HI TECH PHARMA~0.3%~A~076616~001~AT~Mar
17, 2008~No~RX~HI TECH PHARMACAL CO INC
ACETIC ACID, GLACIAL~SOLUTION/DROPS;OTIC~ORLEX~WARNER CHILCOTT~2%~A~086845~001~~
Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT CO LLC
ACETIC ACID, GLACIAL; HYDROCORTISONE~SOLUTION/DROPS;OTIC~ORLEX HC~WARNER CHILCOT
T~2%;1%~A~086844~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT CO

LLC
HYDROCORTISONE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OTIC~OTOBIOTIC~SCHERING~5MG/M
L;EQ 10,000 UNITS BASE/ML~A~062302~001~~Approved Prior to Jan 1, 1982~No~DISCN~S
CHERING CORP SUB SCHERING PLOUGH CORP
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OTIC~OTOCOR
T~WATSON LABS~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~060730~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
HYDROCORTISONE; POLYMYXIN B SULFATE~SOLUTION/DROPS;OTIC~PYOCIDIN~FOREST LABS~5MG
/ML;EQ 10,000 UNITS BASE/ML~A~061606~001~~Approved Prior to Jan 1, 1982~No~DISCN
~FOREST LABORATORIES INC
ACETIC ACID, GLACIAL; DESONIDE~SOLUTION/DROPS;OTIC~TRIDESILON~BAYER PHARMS~2%;0.
05%~N~017914~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS C
ORP
ACETIC ACID, GLACIAL~SOLUTION/DROPS;OTIC~VOSOL~HI TECH PHARMA~2%~N~012179~001~AT
~Approved Prior to Jan 1, 1982~No~RX~HI TECH PHARMACAL CO INC
ACETIC ACID, GLACIAL; HYDROCORTISONE~SOLUTION/DROPS;OTIC~VOSOL HC~HI TECH PHARMA
~2%;1%~N~012770~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~HI TECH PHARMACAL CO
INC
BIMATOPROST~SOLUTION/DROPS;TOPICAL~BIMATOPROST~APOTEX INC~0.03%~A~201894~001~AT~
Dec 1, 2014~No~RX~APOTEX INC
BIMATOPROST~SOLUTION/DROPS;TOPICAL~LATISSE~ALLERGAN~0.03%~N~022369~001~AT~Dec 24
, 2008~Yes~RX~ALLERGAN INC
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~CHLORHEXIDINE GLUCONATE~APOTEX INC~0.12%
~A~075561~001~~Nov 14, 2000~No~DISCN~APOTEX INC
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~CHLORHEXIDINE GLUCONATE~HI TECH PHARMA~0
.12%~A~074356~001~AT~May 7, 1996~No~RX~HI TECH PHARMACAL CO INC
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~CHLORHEXIDINE GLUCONATE~LYNE~0.12%~A~074
291~001~AT~Dec 28, 1995~No~RX~LYNE LABORATORIES INC
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~CHLORHEXIDINE GLUCONATE~TEVA~0.12%~A~074
522~001~AT~Dec 15, 1995~No~RX~TEVA PHARMACEUTICALS USA INC
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~CHLORHEXIDINE GLUCONATE~WOCKHARDT~0.12%~
A~075006~001~AT~Mar 3, 2004~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~CHLORHEXIDINE GLUCONATE~XTTRIUM~0.12%~A~
077789~001~AT~Jun 18, 2009~No~RX~XTTRIUM LABORATORIES INC
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~PAROEX~SUNSTAR AMERICAS~0.12%~A~076434~0
01~AT~Nov 29, 2005~No~RX~SUNSTAR AMERICAS INC
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~PERIDEX~3M~0.12%~N~019028~001~AT~Aug 13,
1986~Yes~RX~3M CO
CHLORHEXIDINE GLUCONATE~SOLUTION;DENTAL~PERIOGARD~COLGATE~0.12%~A~073695~001~AT~
Jan 14, 1994~No~RX~COLGATE ORAL PHARMACEUTICALS INC
METHOCARBAMOL~SOLUTION;IM-IV~METHOCARBAMOL~MYLAN INSTITUTIONAL~1GM/10ML (100MG/M
L)~A~204404~001~AP~Dec 5, 2014~No~RX~MYLAN INSTITUTIONAL LLC
METHOCARBAMOL~SOLUTION;IM-IV~ROBAXIN~HIKMA MAPLE ~1GM/10ML (100MG/ML)~N~011790~0
01~AP~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA MAPLE LTD
ALBUTEROL SULFATE~SOLUTION;INHALATION~ACCUNEB~MYLAN SPECLT~EQ 0.021% BASE~N~0209
49~002~AN~Apr 30, 2001~Yes~RX~MYLAN SPECIALTY LP
ALBUTEROL SULFATE~SOLUTION;INHALATION~ACCUNEB~MYLAN SPECLT~EQ 0.042% BASE~N~0209
49~001~AN~Apr 30, 2001~Yes~RX~MYLAN SPECIALTY LP
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~AEROLONE~LILLY~0.25%~N~007245~00
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~ACTAVIS MID ATLANTIC~EQ
0.083% BASE~A~073533~001~~Sep 26, 1995~No~DISCN~ACTAVIS MID ATLANTIC LLC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~APOTEX INC~EQ 0.021% BAS
E~A~078623~001~~Apr 5, 2010~No~DISCN~APOTEX INC
E~A~078623~002~~Apr 5, 2010~No~DISCN~APOTEX INC
E~A~075717~001~~Feb 2, 2007~No~DISCN~APOTEX INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~APOTEX INC~EQ 0.5% BASE~
A~076391~001~~Apr 1, 2003~No~DISCN~APOTEX INC

ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~BAUSCH AND LOMB~EQ 0.083
% BASE~A~075358~001~~Mar 29, 2000~No~DISCN~BAUSCH AND LOMB INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~BAUSCH AND LOMB~EQ 0.5%
BASE~A~075050~001~AN~Jun 18, 1998~Yes~RX~BAUSCH AND LOMB INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~COPLEY PHARM~EQ 0.083% B
ASE~A~073495~001~~May 28, 1993~No~DISCN~COPLEY PHARMACEUTICAL INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~COPLEY PHARM~EQ 0.5% BAS
E~A~073307~001~~Nov 27, 1991~No~DISCN~COPLEY PHARMACEUTICAL INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~HI TECH PHARMA~EQ 0.083%
BASE~A~075063~001~AN~Feb 9, 1999~No~RX~HI TECH PHARMACAL CO INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~HI TECH PHARMA~EQ 0.5% B
ASE~A~074543~001~AN~Jan 15, 1998~No~RX~HI TECH PHARMACAL CO INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~LANDELA PHARM~EQ 0.083%
BASE~A~077569~001~AN~Apr 4, 2006~No~RX~LANDELA PHARMACEUTICAL
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~MYLAN SPECLT~EQ 0.083% B
ASE~A~072652~001~AN~Feb 21, 1992~Yes~RX~MYLAN SPECIALTY LP
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~NEPHRON~EQ 0.021% BASE~A
~076355~002~AN~Mar 31, 2010~No~RX~NEPHRON PHARMACEUTICALS CORP
~076355~001~AN~Jun 28, 2004~No~RX~NEPHRON PHARMACEUTICALS CORP
~074880~001~AN~Sep 17, 1997~No~RX~NEPHRON CORP
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~NEPHRON~EQ 0.5% BASE~A~0
75664~001~AN~Jun 26, 2001~No~RX~NEPHRON CORP
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~RITEDOSE CORP~EQ 0.083%
BASE~A~077839~001~AN~Dec 16, 2008~No~RX~THE RITEDOSE CORP
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~ROXANE~EQ 0.083% BASE~A~
075129~001~~Feb 13, 2001~No~DISCN~ROXANE LABORATORIES INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~TEVA PHARMS~EQ 0.083% BA
SE~A~075343~001~AN~Nov 9, 1999~No~RX~TEVA PHARMACEUTICALS USA
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~WATSON LABS~EQ 0.021% BA
SE~A~077772~001~AN~Sep 25, 2007~No~RX~WATSON LABORATORIES INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~WATSON LABS~EQ 0.042% BA
SE~A~077772~002~AN~Sep 25, 2007~No~RX~WATSON LABORATORIES INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~WATSON LABS INC~EQ 0.083
% BASE~A~076370~001~AN~Nov 24, 2003~No~RX~WATSON LABORATORIES INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~ALBUTEROL SULFATE~WOCKHARDT EU OPERATN~EQ
0.083% BASE~A~075394~001~~Nov 22, 1999~No~DISCN~WOCKHARDT EU OPERATIONS SWISS AG
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE~SOLUTION;INHALATION~ALBUTEROL SULFATE AND
IPRATROPIUM BROMIDE~APOTEX INC~EQ 0.083% BASE;0.017%~A~077117~001~~Dec 31, 2007
~No~DISCN~APOTEX INC
IPRATROPIUM BROMIDE~CIPLA LTD~EQ 0.083% BASE;0.017%~A~077559~001~AN~Dec 31, 200
7~No~RX~CIPLA LTD
IPRATROPIUM BROMIDE~NEPHRON~EQ 0.083% BASE;0.017%~A~076749~001~AN~Dec 31, 2007~
No~RX~NEPHRON PHARMACEUTICALS CORP
IPRATROPIUM BROMIDE~RITEDOSE CORP~EQ 0.083% BASE;0.017%~A~202496~001~AN~Oct 1,
2012~No~RX~THE RITEDOSE CORP
IPRATROPIUM BROMIDE~SANDOZ INC~EQ 0.083% BASE;0.017%~A~076867~001~~Dec 21, 2006
~No~DISCN~SANDOZ INC
IPRATROPIUM BROMIDE~TEVA PHARMS~EQ 0.083% BASE;0.017%~A~076724~001~AN~Dec 31, 2
IPRATROPIUM BROMIDE~WATSON LABS~EQ 0.083% BASE;0.017%~A~077063~001~AN~Dec 31, 2
METAPROTERENOL SULFATE~SOLUTION;INHALATION~ALUPENT~BOEHRINGER INGELHEIM~0.4%~N~0

18761~002~~Oct 10, 1986~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
METAPROTERENOL SULFATE~SOLUTION;INHALATION~ALUPENT~BOEHRINGER INGELHEIM~0.6%~N~0
18761~001~~Jun 30, 1983~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
METAPROTERENOL SULFATE~SOLUTION;INHALATION~ALUPENT~BOEHRINGER INGELHEIM~5%~N~017
659~001~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTI
CALS INC
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~ATROVENT~BOEHRINGER INGELHEIM~0.02%~N~02
0228~001~~Sep 29, 1993~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~BETA-2~NEPHRON~1%~A~086711~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~NEPHRON CORP
TOBRAMYCIN~SOLUTION;INHALATION~BETHKIS~CHIESI USA INC~300MG/4ML~N~201820~001~~Oc
t 12, 2012~No~RX~CHIESI USA INC
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~BRONKOSOL~SANOFI AVENTIS US~0.25%~
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~BRONKOSOL~SANOFI AVENTIS US~1%~N~0
ARFORMOTEROL TARTRATE~SOLUTION;INHALATION~BROVANA~SUNOVION~EQ 0.015MG BASE/2ML~N
~021912~001~~Oct 6, 2006~Yes~RX~SUNOVION PHARMACEUTICALS INC
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~ACTAVIS MID ATLANTIC~10MG/ML
~A~075067~001~~Jul 19, 1999~No~DISCN~ACTAVIS MID ATLANTIC LLC
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~APOTEX INC~10MG/ML~A~075333~
001~~Apr 30, 2002~No~DISCN~APOTEX INC
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~BAUSCH AND LOMB~10MG/ML~A~07
5585~001~AN~Dec 21, 2000~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~MYLAN SPECLT~10MG/ML~A~07420
9~001~AN~Apr 26, 1994~No~RX~MYLAN SPECIALTY LP
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~PHARMASCIENCE INC~10MG/ML~A~
075437~001~~Apr 21, 2000~No~DISCN~PHARMASCIENCE INC
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~ROXANE~10MG/ML~A~075175~001~
~Sep 30, 1999~No~DISCN~ROXANE LABORATORIES INC
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~TEVA PHARMS~10MG/ML~A~075271
~001~AN~Jan 18, 2000~Yes~RX~TEVA PHARMACEUTICALS USA
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~WATSON LABS~10MG/ML~A~076469
~001~~Jun 17, 2005~No~DISCN~WATSON LABORATORIES INC
CROMOLYN SODIUM~SOLUTION;INHALATION~CROMOLYN SODIUM~WOCKHARDT~10MG/ML~A~075346~0
01~AN~Oct 25, 1999~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE~SOLUTION;INHALATION~DUONEB~MYLAN SPECLT~E
Q 0.083% BASE;0.017%~N~020950~001~AN~Mar 21, 2001~Yes~RX~MYLAN SPECIALTY LP
CROMOLYN SODIUM~SOLUTION;INHALATION~INTAL~KING PHARMS~10MG/ML~N~018596~001~~May
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~ACTAVIS MID ATLANTIC
~0.02%~A~075111~001~~Apr 22, 1999~No~DISCN~ACTAVIS MID ATLANTIC LLC
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~APOTEX INC~0.02%~A~0
75441~001~~Mar 28, 2001~No~DISCN~APOTEX INC
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~BAUSCH AND LOMB~0.02
%~A~075835~001~AN~Oct 15, 2001~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~LANDELA PHARM~0.02%~
A~077072~001~AN~Jul 19, 2005~No~RX~LANDELA PHARMACEUTICAL
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~MYLAN SPECLT~0.02%~A
~074755~001~AN~Jan 10, 1997~Yes~RX~MYLAN SPECIALTY LP
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~NEPHRON~0.02%~A~0755
62~001~AN~Sep 27, 2001~No~RX~NEPHRON CORP
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~PHARMASCIENCE INC~0.
02%~A~075507~001~~Jan 19, 2001~No~DISCN~PHARMASCIENCE INC
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~RITEDOSE CORP~0.02%~
A~075693~001~AN~Jan 26, 2001~No~RX~THE RITEDOSE CORP
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~ROXANE~0.02%~A~07586
IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~TEVA PHARMS USA~0.02
%~A~075313~001~~Feb 7, 2000~No~DISCN~TEVA PHARMACEUTICALS USA

IPRATROPIUM BROMIDE~SOLUTION;INHALATION~IPRATROPIUM BROMIDE~WATSON LABS~0.02%~A~
076291~001~AN~May 9, 2005~No~RX~WATSON LABORATORIES INC
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~ALPHARMA
US PHARMS~1%~A~087101~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US P
HARMACEUTICALS DIVISION
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~ASTRAZEN
ECA~0.062%~A~087937~001~~Nov 15, 1982~No~DISCN~ASTRAZENECA LP
ECA~0.062%~A~089614~001~~Jun 13, 1991~No~DISCN~ASTRAZENECA LP
ECA~0.125%~A~087938~001~~Nov 15, 1982~No~DISCN~ASTRAZENECA LP
ECA~0.167%~A~088470~001~~Mar 14, 1984~No~DISCN~ASTRAZENECA LP
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~BAXTER H
LTHCARE~0.08%~A~088144~001~~Jul 29, 1983~No~DISCN~BAXTER HEALTHCARE CORP
LTHCARE~0.14%~A~088145~001~~Mar 26, 1984~No~DISCN~BAXTER HEALTHCARE CORP
LTHCARE~0.25%~A~088146~001~~Aug 1, 1983~No~DISCN~BAXTER HEALTHCARE CORP
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~DEY~0.08
%~A~088187~001~~Dec 3, 1982~No~DISCN~DEY LP
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~DEY~0.1%
~A~087389~001~~Approved Prior to Jan 1, 1982~No~DISCN~DEY LP
%~A~087390~001~~Approved Prior to Jan 1, 1982~No~DISCN~DEY LP
%~A~088188~001~~Dec 3, 1982~No~DISCN~DEY LP
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~DEY~1%~A
~086763~001~~Approved Prior to Jan 1, 1982~No~DISCN~DEY LP
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~INTL MED
ICATION~0.077%~A~086651~001~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONA
ICATION~0.08%~A~086651~002~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL

ICATION~1%~A~086651~008~~Approved Prior to Jan 1, 1982~No~DISCN~INTERNATIONAL ME
DICATION SYSTEMS LTD
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~PARKE DA
VIS~0.5%~A~085997~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS PHARMA
CEUTICAL RESEARCH DIV WARNER LAMBERT CO
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~PARKE DA
VIS~1%~A~085889~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS PHARMACE
UTICAL RESEARCH DIV WARNER LAMBERT CO
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE~ROXANE~0
.1%~A~087396~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
.125%~A~087025~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES I
NC
.167%~A~088226~001~~Sep 16, 1983~No~DISCN~ROXANE LABORATORIES INC
.2%~A~087324~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
.25%~A~088275~001~~Jun 3, 1983~No~DISCN~ROXANE LABORATORIES INC
%~A~086899~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
ISOETHARINE HYDROCHLORIDE~SOLUTION;INHALATION~ISOETHARINE HYDROCHLORIDE S/F~DEY~
0.08%~A~089817~001~~Nov 22, 1988~No~DISCN~DEY LP
1%~A~089252~001~~Sep 15, 1986~No~DISCN~DEY LP
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~ISOPROTERENOL HYDROCHLORIDE~ARMO
UR PHARM~0.031%~A~087935~001~~Nov 18, 1982~No~DISCN~ARMOUR PHARMACEUTICAL CO
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~ISOPROTERENOL HYDROCHLORIDE~ARMO
UR PHARM~0.062%~A~087936~001~~Nov 18, 1982~No~DISCN~ARMOUR PHARMACEUTICAL CO
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~ISOPROTERENOL HYDROCHLORIDE~DEY~
0.5%~A~086764~001~~Jan 4, 1982~No~DISCN~DEY LP
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~ISOPROTERENOL HYDROCHLORIDE~PARK
E DAVIS~0.25%~A~085994~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS D
IV WARNER LAMBERT CO
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~ISOPROTERENOL HYDROCHLORIDE~PARK
E DAVIS~0.5%~A~085540~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DI
V WARNER LAMBERT CO
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~ISUPREL~SANOFI AVENTIS US~0.5%~N
~006327~002~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~ISUPREL~SANOFI AVENTIS US~1%~N~0
TOBRAMYCIN~SOLUTION;INHALATION~KITABIS PAK~PULMOFLOW INC~300MG/5ML~N~205433~001~
AN~Dec 2, 2014~No~RX~PULMOFLOW INC
LEVALBUTEROL HYDROCHLORIDE~SOLUTION;INHALATION~LEVALBUTEROL HYDROCHLORIDE~CIPLA
LTD~EQ 0.021% BASE~A~078171~002~AN~Dec 13, 2013~No~RX~CIPLA LTD
LEVALBUTEROL HYDROCHLORIDE~SOLUTION;INHALATION~LEVALBUTEROL HYDROCHLORIDE~MYLAN
SPECLT~EQ 0.0103% BASE~A~077800~001~AN~Mar 15, 2013~No~RX~MYLAN SPECIALTY LP

LEVALBUTEROL HYDROCHLORIDE~SOLUTION;INHALATION~LEVALBUTEROL HYDROCHLORIDE~TEVA P
ARENTERAL~EQ 0.25% BASE~A~200875~001~AN~Sep 11, 2014~No~RX~TEVA PARENTERAL MEDIC
INES INC
HARMS USA~EQ 0.0103% BASE~A~090297~001~AN~Apr 26, 2013~No~RX~TEVA PHARMACEUTICAL
S USA
HARMS USA~EQ 0.021% BASE~A~090297~002~AN~Apr 26, 2013~No~RX~TEVA PHARMACEUTICALS
USA
HARMS USA~EQ 0.042% BASE~A~090297~003~AN~Apr 26, 2013~No~RX~TEVA PHARMACEUTICALS
USA
LEVALBUTEROL HYDROCHLORIDE~SOLUTION;INHALATION~LEVALBUTEROL HYDROCHLORIDE~WATSON
LABS INC~EQ 0.0103% BASE~A~077756~003~AN~Apr 9, 2008~No~RX~WATSON LABORATORIES
INC
LABS INC~EQ 0.021% BASE~A~077756~001~AN~Apr 9, 2008~No~RX~WATSON LABORATORIES I
NC
LABS INC~EQ 0.042% BASE~A~077756~002~AN~Apr 9, 2008~No~RX~WATSON LABORATORIES I
NC
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~APOTEX INC~0.4
%~A~075402~001~~Feb 28, 2001~No~DISCN~APOTEX INC
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~APOTEX INC~0.6
%~A~075403~001~~Feb 28, 2001~No~DISCN~APOTEX INC
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~ASTRAZENECA~0.
4%~A~071275~001~~Jul 27, 1988~No~DISCN~ASTRAZENECA LP
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~ASTRAZENECA~0.
6%~A~071018~001~~Jul 27, 1988~No~DISCN~ASTRAZENECA LP
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~DEY~0.33%~A~07
1806~001~~Aug 5, 1988~No~DISCN~DEY LP
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~DEY~0.5%~A~071
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~DEY~5%~A~07080
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~MYLAN SPECLT~0
.4%~A~071786~001~AN~Aug 5, 1988~Yes~RX~MYLAN SPECIALTY LP
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~MYLAN SPECLT~0
.6%~A~070804~001~AN~Aug 17, 1987~Yes~RX~MYLAN SPECIALTY LP
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~NEPHRON~0.4%~A
~071855~001~~Jul 14, 1988~No~DISCN~NEPHRON PHARMACEUTICALS CORP
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~NEPHRON~0.6%~A
~071726~001~~Jul 14, 1988~No~DISCN~NEPHRON PHARMACEUTICALS CORP
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~WOCKHARDT~0.4%
~A~075586~001~AN~May 30, 2002~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~WOCKHARDT~0.6%
~A~075586~002~AN~May 30, 2002~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
METAPROTERENOL SULFATE~SOLUTION;INHALATION~METAPROTERENOL SULFATE~WOCKHARDT~5%~A
~072190~001~~Jun 7, 1988~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~MUCOMYST W/ ISOP
ROTERENOL~MEAD JOHNSON~10%;0.05%~N~017366~001~~Approved Prior to Jan 1, 1982~No~
DISCN~MEAD JOHNSON AND CO SUB BRISTOL MYERS CO
FORMOTEROL FUMARATE~SOLUTION;INHALATION~PERFOROMIST~MYLAN SPECLT~0.02MG/2ML~N~02
2007~001~~May 11, 2007~Yes~RX~MYLAN SPECIALTY LP

METAPROTERENOL SULFATE~SOLUTION;INHALATION~PROMETA~MURO~5%~A~073340~001~~Mar 30,
1992~No~DISCN~MURO PHARMACEUTICAL INC
ALBUTEROL SULFATE~SOLUTION;INHALATION~PROVENTIL~SCHERING~EQ 0.083% BASE~N~019243
~002~~Jan 14, 1987~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
ALBUTEROL SULFATE~SOLUTION;INHALATION~PROVENTIL~SCHERING~EQ 0.5% BASE~N~019243~0
01~~Jan 14, 1987~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
NEDOCROMIL SODIUM~SOLUTION;INHALATION~TILADE~SANOFI AVENTIS US~0.5%~N~020750~001
~~Oct 1, 1997~No~DISCN~SANOFI AVENTIS US LLC
TOBRAMYCIN~SOLUTION;INHALATION~TOBI~NOVARTIS PHARMS~300MG/5ML~N~050753~001~AN~De
c 22, 1997~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
TOBRAMYCIN~SOLUTION;INHALATION~TOBRAMYCIN~AKORN INC~300MG/5ML~A~201422~001~AN~Ma
y 28, 2014~No~RX~AKORN INC
TOBRAMYCIN~SOLUTION;INHALATION~TOBRAMYCIN~TEVA PHARMS USA~300MG/5ML~A~091589~001
~AN~Oct 10, 2013~No~RX~TEVA PHARMACEUTICALS USA
BITOLTEROL MESYLATE~SOLUTION;INHALATION~TORNALATE~SANOFI AVENTIS US~0.2%~N~01954
8~001~~Feb 19, 1992~No~DISCN~SANOFI AVENTIS US LLC
TREPROSTINIL~SOLUTION;INHALATION~TYVASO~UNITED THERAP~0.6MG/ML~N~022387~001~~Jul
30, 2009~Yes~RX~UNITED THERAPEUTICS CORP
ISOPROTERENOL HYDROCHLORIDE~SOLUTION;INHALATION~VAPO-ISO~FISONS~0.5%~N~016813~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~FISONS CORP
ILOPROST~SOLUTION;INHALATION~VENTAVIS~ACTELION PHARMS LTD~10MCG/ML (10MCG/ML)~N~
021779~002~~Dec 8, 2005~Yes~RX~ACTELION PHARMACEUTICALS LTD
ILOPROST~SOLUTION;INHALATION~VENTAVIS~ACTELION PHARMS LTD~20MCG/2ML (10MCG/ML)~N
~021779~001~~Dec 29, 2004~No~DISCN~ACTELION PHARMACEUTICALS LTD
ILOPROST~SOLUTION;INHALATION~VENTAVIS~ACTELION PHARMS LTD~20MCG/ML (20MCG/ML)~N~
021779~003~~Aug 7, 2009~Yes~RX~ACTELION PHARMACEUTICALS LTD
ALBUTEROL SULFATE~SOLUTION;INHALATION~VENTOLIN~GLAXOSMITHKLINE~EQ 0.083% BASE~N~
019773~001~~Apr 23, 1992~No~DISCN~GLAXOSMITHKLINE
ALBUTEROL SULFATE~SOLUTION;INHALATION~VENTOLIN~GLAXOSMITHKLINE~EQ 0.5% BASE~N~01
9269~002~~Jan 16, 1987~No~DISCN~GLAXOSMITHKLINE
LEVALBUTEROL HYDROCHLORIDE~SOLUTION;INHALATION~XOPENEX~OAK PHARMS INC~EQ 0.0103%
BASE~N~020837~003~AN~Jan 30, 2002~Yes~RX~OAK PHARMACEUTICALS INC SUBSIDIARY OF
AKORN INC
BASE~N~020837~001~AN~Mar 25, 1999~Yes~RX~OAK PHARMACEUTICALS INC SUBSIDIARY OF A
KORN INC
BASE~N~020837~002~AN~Mar 25, 1999~Yes~RX~OAK PHARMACEUTICALS INC SUBSIDIARY OF A
KORN INC
LEVALBUTEROL HYDROCHLORIDE~SOLUTION;INHALATION~XOPENEX~OAK PHARMS INC~EQ 0.25% B
ASE~N~020837~004~AN~Jul 18, 2003~Yes~RX~OAK PHARMACEUTICALS INC SUBSIDIARY OF AK
ORN INC
XENON XE-133~SOLUTION;INHALATION, INJECTION~XENEISOL~MALLINCKRODT~18-25mCi/AMP~N
~017262~002~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT INC
PENTETATE CALCIUM TRISODIUM~SOLUTION;INHALATION, INTRAVENOUS~PENTETATE CALCIUM T
RISODIUM~HAMELN PHARMS~EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register det
reasons**~N~021749~001~~Aug 11, 2004~No~DISCN~HAMELN PHARMACEUTICALS GMBH
PENTETATE ZINC TRISODIUM~SOLUTION;INHALATION, INTRAVENOUS~PENTETATE ZINC TRISODI
UM~HAMELN PHARMS~EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determina
ns**~N~021751~001~~Aug 11, 2004~No~DISCN~HAMELN PHARMACEUTICALS GMBH
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~ACETYLCYSTEINE~HOSPIRA~10%~A~071364~001
~~May 1, 1989~No~DISCN~HOSPIRA INC
~AN~Aug 30, 1994~No~RX~HOSPIRA INC
~~May 1, 1989~No~DISCN~HOSPIRA INC
~AN~Aug 30, 1994~No~RX~HOSPIRA INC

ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~ACETYLCYSTEINE~INNOPHARMA LICENSING~10%
~A~204674~001~AN~Feb 11, 2014~No~RX~INNOPHARMA LICENSING LLC
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~ACETYLCYSTEINE~INNOPHARMA LICENSING~20%
~A~203853~001~AN~Jun 21, 2012~No~RX~INNOPHARMA LICENSING LLC
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~ACETYLCYSTEINE~LUITPOLD~10%~A~072489~00
1~AN~Jul 28, 1995~Yes~RX~LUITPOLD PHARMACEUTICALS INC
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~ACETYLCYSTEINE~LUITPOLD~20%~A~072547~00
1~AN~Jul 28, 1995~Yes~RX~LUITPOLD PHARMACEUTICALS INC
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~ACETYLCYSTEINE~ROXANE~10%~A~072323~001~
~Apr 30, 1992~No~DISCN~ROXANE LABORATORIES INC
~Apr 30, 1992~No~DISCN~ROXANE LABORATORIES INC
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~MUCOMYST~APOTHECON~10%~N~013601~002~~Ap
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~MUCOMYST~APOTHECON~20%~N~013601~001~~Ap
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~MUCOSIL-10~DEY~10%~A~070575~001~~Oct 14
, 1986~No~DISCN~DEY LP
ACETYLCYSTEINE~SOLUTION;INHALATION, ORAL~MUCOSIL-20~DEY~20%~A~070576~001~~Oct 14
, 1986~No~DISCN~DEY LP
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE~SOLUTION;INJECTION~NORMO
CARB HF 25~DIALYSIS SUPS~0.21GM/100ML;2.8GM/100ML;9.07GM/100ML~N~021910~001~~Jul
26, 2006~Yes~RX~DIALYSIS SUPPLIES INC
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE~SOLUTION;INJECTION~NORMO
CARB HF 35~DIALYSIS SUPS~0.21GM/100ML;3.97GM/100ML;8.3GM/100ML~N~021910~002~~Jul
26, 2006~Yes~RX~DIALYSIS SUPPLIES INC
TECHNETIUM TC-99M SULFUR COLLOID KIT~SOLUTION;INJECTION, ORAL~AN-SULFUR COLLOID~
PHARMALUCENCE~N/A~N~017858~001~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMALUCEN
CE INC
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR~SOLUTION;INJECTION, ORAL~MINITE
C~BRACCO~0.22-2.22 CI/GENERATOR~N~017339~001~~Approved Prior to Jan 1, 1982~No~D
ISCN~BRACCO DIAGNOSTICS INC
IOHEXOL~SOLUTION;INJECTION, ORAL~OMNIPAQUE 350~GE HEALTHCARE~75.5%~N~018956~004~
~Dec 26, 1985~Yes~RX~GE HEALTHCARE
IOHEXOL~SOLUTION;INJECTION, ORAL~OMNIPAQUE 350~GE HEALTHCARE~75.5%~N~020608~003~
~Oct 24, 1995~No~RX~GE HEALTHCARE
SODIUM PHOSPHATE P-32~SOLUTION;INJECTION, ORAL~PHOSPHOTOPE~BRACCO~1-8mCi/VIAL~N~
TECHNETIUM TC-99M SODIUM PERTECHNETATE~SOLUTION;INJECTION, ORAL~SODIUM PERTECHNE
TATE TC 99M~GE HEALTHCARE~2-100mCi/ML **Federal Register notice determination th
at product was not discontinued or withdrawn for safety or efficacy reasons**~N~
TATE TC 99M~MALLINCKRODT~10-60mCi/ML **Federal Register determination that produ
TATE TC 99M~PHARMALUCENCE~12mCi/ML~N~017321~001~~Approved Prior to Jan 1, 1982~N
o~DISCN~PHARMALUCENCE INC
SODIUM PHOSPHATE P-32~SOLUTION;INJECTION, ORAL~SODIUM PHOSPHATE P 32~MALLINCKROD

T~0.67mCi/ML~N~011777~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT M
EDICAL INC
SODIUM PHOSPHATE P-32~SOLUTION;INJECTION, ORAL~SODIUM PHOSPHATE P 32~MALLINCKROD
T~1.5mCi/VIAL~N~011777~002~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT
MEDICAL INC
TECHNETIUM TC-99M SULFUR COLLOID KIT~SOLUTION;INJECTION, ORAL~TECHNECOLL~MALLINC
KRODT~N/A~N~017059~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDI
CAL INC
TECHNETIUM TC-99M SULFUR COLLOID~SOLUTION;INJECTION, ORAL~TECHNETIUM TC 99M SULF
UR COLLOID~GE HEALTHCARE~4mCi/ML~N~017456~001~~Approved Prior to Jan 1, 1982~No~
DISCN~GE HEALTHCARE
TECHNETIUM TC-99M SULFUR COLLOID KIT~SOLUTION;INJECTION, ORAL~TECHNETIUM TC 99M
TSC~GE HEALTHCARE~N/A~N~017784~001~~Approved Prior to Jan 1, 1982~No~DISCN~GE HE
ALTHCARE
TECHNETIUM TC-99M SULFUR COLLOID KIT~SOLUTION;INJECTION, ORAL~TESULOID~BRACCO~N/
A~N~016923~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
IOHEXOL~SOLUTION;INJECTION, ORAL, RECTAL~OMNIPAQUE 180~GE HEALTHCARE~38.8%~N~018
608~001~~Oct 24, 1995~No~RX~GE HEALTHCARE
608~002~~Oct 24, 1995~No~RX~GE HEALTHCARE
HYDROXYPROGESTERONE CAPROATE~SOLUTION;INTRAMUSCULAR~MAKENA~LUMARA HEALTH INC~125
0MG/5ML (250MG/ML)~N~021945~001~~Feb 3, 2011~Yes~RX~LUMARA HEALTH INC
MORPHINE SULFATE~SOLUTION;INTRAMUSCULAR, INTRAVENOUS~MORPHINE SULFATE~BD RX~2MG/
ML (2MG/ML)~N~204223~001~~Oct 30, 2013~Yes~RX~BD RX INC
MORPHINE SULFATE~SOLUTION;INTRAMUSCULAR, INTRAVENOUS~MORPHINE SULFATE~BD RX~10MG
/ML (10MG/ML)~N~204223~005~~Oct 30, 2013~Yes~RX~BD RX INC
NALOXONE HYDROCHLORIDE~SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS~EVZIO~KALEO INC~0.4M
G/0.4ML~N~205787~001~~Apr 3, 2014~Yes~RX~KALEO INC
CARBACHOL~SOLUTION;INTRAOCULAR~CARBACHOL~PHARMAFAIR~0.01%~A~070292~001~~May 21,
CARBACHOL~SOLUTION;INTRAOCULAR~CARBASTAT~NOVARTIS~0.01%~A~073677~001~~Apr 28, 19
CARBACHOL~SOLUTION;INTRAOCULAR~MIOSTAT~ALCON~0.01%~N~016968~001~~Approved Prior
to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE~
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER~FRESENIUS
MEDCL~25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML~N~018379~00
2~AT~Approved Prior to Jan 1, 1982~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
1~AT~Nov 30, 1984~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTA
INER~FRESENIUS MEDCL~25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100
ML~N~018883~004~AT~Nov 30, 1984~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN P

LASTIC CONTAINER~FRESENIUS MEDCL~18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100
ML;448MG/100ML~N~020171~001~AT~Aug 19, 1992~No~RX~FRESENIUS MEDICAL CARE NORTH A
MERICA
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTA
INER~FRESENIUS MEDCL~25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100
ML~N~018883~005~AT~Nov 30, 1984~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN P
LASTIC CONTAINER~FRESENIUS MEDCL~18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100
ML;448MG/100ML~N~020171~002~AT~Aug 19, 1992~No~RX~FRESENIUS MEDICAL CARE NORTH A
MERICA
7~AT~Jun 24, 1988~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER~FRESENIU
S MEDCL~25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML~N~018379~
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER~FRESENIU
S MEDCL~25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML~N~018883~
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONT
AINER~FRESENIUS MEDCL~25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/1
00ML~N~018883~006~AT~Nov 30, 1984~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
SOLUTION;INTRAPERITONEAL~DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN
PLASTIC CONTAINER~FRESENIUS MEDCL~18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/1
00ML;448MG/100ML~N~020171~003~AT~Aug 19, 1992~No~RX~FRESENIUS MEDICAL CARE NORTH
AMERICA
SOLUTION;INTRAPERITONEAL~DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER~FRESEN
IUS MEDCL~25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML~N~018379
~004~AT~Jul 7, 1982~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
~005~AT~Jul 7, 1982~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
~008~AT~Jun 24, 1988~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
SOLUTION;INTRAPERITONEAL~DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER~FRESE
NIUS MEDCL~25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML~N~0183
79~006~AT~Jul 7, 1982~No~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE~
SOLUTION;INTRAPERITONEAL~DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINE
R~B BRAUN~510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML~N~018807~00
1~~Aug 26, 1983~Yes~RX~B BRAUN MEDICAL INC
R~B BRAUN~510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML~N~018807~003
~~Aug 26, 1983~Yes~RX~B BRAUN MEDICAL INC
R~B BRAUN~510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML~N~018807~00
2~~Aug 26, 1983~Yes~RX~B BRAUN MEDICAL INC
R~B BRAUN~510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML~N~018807~004
~~Aug 26, 1983~Yes~RX~B BRAUN MEDICAL INC
SOLUTION;INTRAPERITONEAL~DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER~B BRAUN~
26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML~N~018460~007~~Jan 29, 1
26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML~N~018460~002~~Approved
26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML~N~018460~005~~Nov 2, 19
26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML~N~018460~008~~Jan 29, 198
29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML~N~018460~006~~Jan 29,
SOLUTION;INTRAPERITONEAL~DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER~B BRAUN
~26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML~N~018460~009~~Jan 29,
SOLUTION;INTRAPERITONEAL~DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER~B BRAUN
~26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML~N~018460~004~~Approv
ed Prior to Jan 1, 1982~No~DISCN~B BRAUN MEDICAL INC
SOLUTION;INTRAPERITONEAL~DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER~B BRAUN~2
9MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML~N~018460~001~~Approved
SOLUTION;INTRAPERITONEAL~DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER~B BRAUN~
29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML~N~018460~003~~Approve
SOLUTION;INTRAPERITONEAL~DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER~BAXTE
R HLTHCARE~25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML~N~01751
2~001~AT~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
SOLUTION;INTRAPERITONEAL~DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER~BAXTE
R HLTHCARE~25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML~N~01751
SOLUTION;INTRAPERITONEAL~DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER~BAXT
ER HLTHCARE~25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML~N~017
SOLUTION;INTRAPERITONEAL~DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAIN
ER~BAXTER HLTHCARE~18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
~N~020183~001~AT~Dec 4, 1992~No~RX~BAXTER HEALTHCARE CORP
~N~020183~002~~Dec 4, 1992~No~RX~BAXTER HEALTHCARE CORP
~N~020183~003~~Dec 4, 1992~No~RX~BAXTER HEALTHCARE CORP
SOLUTION;INTRAPERITONEAL~DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAI
NER~BAXTER HLTHCARE~18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100
ML~N~020183~004~~Dec 4, 1992~No~RX~BAXTER HEALTHCARE CORP
SOLUTION;INTRAPERITONEAL~DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER~BAXT
12~007~AT~Jul 9, 1984~No~RX~BAXTER HEALTHCARE CORP
12~010~AT~Nov 18, 1985~No~RX~BAXTER HEALTHCARE CORP
SOLUTION;INTRAPERITONEAL~DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER~BAX
TER HLTHCARE~25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML~N~01
63~001~AT~Dec 4, 1992~No~RX~BAXTER HEALTHCARE CORP
12~011~AT~Nov 18, 1985~No~RX~BAXTER HEALTHCARE CORP
ICODEXTRIN~SOLUTION;INTRAPERITONEAL~EXTRANEAL~BAXTER HLTHCARE~7.5GM/100ML~N~0213
21~001~~Dec 20, 2002~Yes~RX~BAXTER HEALTHCARE CORP
SOLUTION;INTRAPERITONEAL~INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER~FR
ESENIUS~18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML~A~020374~0
01~~Jun 13, 1994~No~DISCN~FRESENIUS USA INC
SOLUTION;INTRAPERITONEAL~INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER~F
RESENIUS~18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML~A~020374
~004~~Jun 13, 1994~No~DISCN~FRESENIUS USA INC
CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE~SOLUTION;INTRAPERITO
NEAL~INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER~FRESENIUS MEDCL~25.7MG/10
0ML;1.5GM/100ML;538MG/100ML;448MG/100ML~N~019395~001~~Mar 26, 1986~No~DISCN~FRES
ENIUS MEDICAL CARE NORTH AMERICA
0ML;2.5GM/100ML;538MG/100ML;448MG/100ML~N~019395~002~~Mar 26, 1986~No~DISCN~FRES
ENIUS MEDICAL CARE NORTH AMERICA
00ML;4.25GM/100ML;538MG/100ML;448MG/100ML~N~019395~003~~Mar 26, 1986~No~DISCN~FR
ESENIUS MEDICAL CARE NORTH AMERICA
ACETRIZOATE SODIUM~SOLUTION;INTRAUTERINE~SALPIX~ORTHO MCNEIL PHARM~53%~N~009008~
001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE~SOLUTION;INTRAUTERINE~SINOGRAFIN~BRA
CCO~52.7%;26.8%~N~011324~002~~Approved Prior to Jan 1, 1982~Yes~RX~BRACCO DIAGNO
STICS INC
GADOFOSVESET TRISODIUM~SOLUTION;INTRAVENOUS~ABLAVAR~LANTHEUS MEDCL~2440MG/10ML (
244MG/ML)~N~021711~001~~Dec 22, 2008~No~RX~LANTHEUS MEDICAL IMAGING INC
GADOFOSVESET TRISODIUM~SOLUTION;INTRAVENOUS~ABLAVAR~LANTHEUS MEDCL~3660MG/15ML (
244MG/ML)~N~021711~002~~Dec 22, 2008~Yes~RX~LANTHEUS MEDICAL IMAGING INC
IOBENGUANE SULFATE I-123~SOLUTION;INTRAVENOUS~ADREVIEW~GE HEALTHCARE~10mCi/5ML (
2mCi/ML)~N~022290~001~~Sep 19, 2008~Yes~RX~GE HEALTHCARE
FLORBETAPIR F-18~SOLUTION;INTRAVENOUS~AMYVID~AVID RADIOPHARMS INC~10ML (13.5-51m
Ci/ML)~N~202008~001~~Apr 6, 2012~Yes~RX~AVID RADIOPHARMACEUTICALS INC
FLORBETAPIR F-18~SOLUTION;INTRAVENOUS~AMYVID~AVID RADIOPHARMS INC~10-30ML (13.551mCi/ML)~N~202008~002~~Apr 6, 2012~Yes~RX~AVID RADIOPHARMACEUTICALS INC
FLORBETAPIR F-18~SOLUTION;INTRAVENOUS~AMYVID~AVID RADIOPHARMS INC~10-50ML (13.551mCi/ML)~N~202008~003~~Apr 6, 2012~Yes~RX~AVID RADIOPHARMACEUTICALS INC
POLIDOCANOL~SOLUTION;INTRAVENOUS~ASCLERA~CHEMISCH FBRK KRSSLR~10MG/2ML (5MG/ML)~
N~021201~001~~Mar 30, 2010~No~RX~CHEMISCHE FABRIK KREUSSLER & CO. GMBH
POLIDOCANOL~SOLUTION;INTRAVENOUS~ASCLERA~CHEMISCH FBRK KRSSLR~20MG/2ML (10MG/ML)
~N~021201~002~~Mar 30, 2010~Yes~RX~CHEMISCHE FABRIK KREUSSLER & CO. GMBH
NEOSTIGMINE METHYLSULFATE~SOLUTION;INTRAVENOUS~BLOXIVERZ~ECLAT PHARMS LLC~5MG/10
ML (0.5MG/ML)~N~204078~001~~May 31, 2013~Yes~RX~ECLAT PHARMACEUTICALS LLC
NEOSTIGMINE METHYLSULFATE~SOLUTION;INTRAVENOUS~BLOXIVERZ~ECLAT PHARMS LLC~10MG/1
0ML (1MG/ML)~N~204078~002~~May 31, 2013~Yes~RX~ECLAT PHARMACEUTICALS LLC
CAFFEINE CITRATE~SOLUTION;INTRAVENOUS~CAFCIT~EUROHLTH INTL SARL~EQ 30MG BASE/3ML
(EQ 10MG BASE/ML)~N~020793~001~AP~Sep 21, 1999~Yes~RX~EUROHEALTH INTERNATIONAL
SARL
CAFFEINE CITRATE~SOLUTION;INTRAVENOUS~CAFFEINE CITRATE~EXELA PHARMA SCIENCE~EQ 3

0MG BASE/3ML (EQ 10MG BASE/ML)~A~077233~001~AP~Sep 21, 2006~No~RX~EXELA PHARMA S
CIENCES
CAFFEINE CITRATE~SOLUTION;INTRAVENOUS~CAFFEINE CITRATE~FRESENIUS KABI USA~EQ 30M
G BASE/3ML (EQ 10MG BASE/ML)~A~077997~001~AP~Jul 20, 2007~No~RX~FRESENIUS KABI U
SA LLC
CAFFEINE CITRATE~SOLUTION;INTRAVENOUS~CAFFEINE CITRATE~LUITPOLD~EQ 30MG BASE/3ML
(EQ 10MG BASE/ML)~A~077906~001~AP~May 15, 2007~No~RX~LUITPOLD PHARMACEUTICALS I
NC
CAFFEINE CITRATE~SOLUTION;INTRAVENOUS~CAFFEINE CITRATE~SAGENT PHARMS~EQ 30MG BAS
E/3ML (EQ 10MG BASE/ML)~A~090827~001~AP~Aug 29, 2012~No~RX~SAGENT PHARMACEUTICAL
S INC
CAFFEINE CITRATE~SOLUTION;INTRAVENOUS~CAFFEINE CITRATE~SUN PHARMA GLOBAL~EQ 30MG
BASE/3ML (EQ 10MG BASE/ML)~A~090077~001~AP~Sep 30, 2009~No~RX~SUN PHARMA GLOBAL
FZE
IBUPROFEN~SOLUTION;INTRAVENOUS~CALDOLOR~CUMBERLAND PHARMS~400MG/4ML (100MG/ML)~N
~022348~001~~Jun 11, 2009~No~DISCN~CUMBERLAND PHARMACEUTICALS INC
IBUPROFEN~SOLUTION;INTRAVENOUS~CALDOLOR~CUMBERLAND PHARMS~800MG/8ML (100MG/ML)~N
~022348~002~~Jun 11, 2009~Yes~RX~CUMBERLAND PHARMACEUTICALS INC
COSYNTROPIN~SOLUTION;INTRAVENOUS~COSYNTROPIN~SANDOZ~0.25MG/ML (0.25MG/ML)~N~0220
28~001~~Feb 21, 2008~No~DISCN~SANDOZ CANADA INC
IOFLUPANE I-123~SOLUTION;INTRAVENOUS~DATSCAN~GE HLTHCARE INC~5mCi/2.5ML (2mCi/ML
)~N~022454~001~~Jan 14, 2011~Yes~RX~GE HEALTHCARE INC
GADOTERATE MEGLUMINE~SOLUTION;INTRAVENOUS~DOTAREM~GUERBET~3.769GM/10ML (376.9MG/
ML)~N~204781~002~~Mar 20, 2013~Yes~RX~GUERBET LLC
GADOTERATE MEGLUMINE~SOLUTION;INTRAVENOUS~DOTAREM~GUERBET~5.6535GM/15ML (376.9MG
/ML)~N~204781~003~~Mar 20, 2013~Yes~RX~GUERBET LLC
GADOTERATE MEGLUMINE~SOLUTION;INTRAVENOUS~DOTAREM~GUERBET~7.538GM/20ML (376.9MG/
ML)~N~204781~004~~Mar 20, 2013~Yes~RX~GUERBET LLC
GADOTERATE MEGLUMINE~SOLUTION;INTRAVENOUS~DOTAREM~GUERBET~37.69GM/100ML (376.9MG
/ML)~N~204781~001~~Mar 20, 2013~Yes~RX~GUERBET LLC
DICLOFENAC SODIUM~SOLUTION;INTRAVENOUS~DYLOJECT~JAVELIN PHARMS INC~37.5MG/ML (37
.5MG/ML)~N~022396~001~~Dec 23, 2014~Yes~RX~JAVELIN PHARMACEUTICALS INC A WHOLLY
OWNED SUDSIDIARY OF HOSPIRA INC
GADOXETATE DISODIUM~SOLUTION;INTRAVENOUS~EOVIST~BAYER HLTHCARE~1.8143GM/10ML (18
1.43MG/ML)~N~022090~001~~Jul 3, 2008~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
GADOXETATE DISODIUM~SOLUTION;INTRAVENOUS~EOVIST~BAYER HLTHCARE~2.72145GM/15ML (1
81.43MG/ML)~N~022090~002~~Feb 4, 2013~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
FERUMOXYTOL~SOLUTION;INTRAVENOUS~FERAHEME~AMAG PHARMS INC~EQ 510MG IRON/17ML (EQ
30MG IRON/ML)~N~022180~001~~Jun 30, 2009~Yes~RX~AMAG PHARMACEUTICALS INC
PRALATREXATE~SOLUTION;INTRAVENOUS~FOLOTYN~ALLOS~20MG/ML (20MG/ML)~N~022468~001~~
Sep 24, 2009~No~RX~ALLOS THERAPEUTICS INC
PRALATREXATE~SOLUTION;INTRAVENOUS~FOLOTYN~ALLOS~40MG/2ML (20MG/ML)~N~022468~002~
~Sep 24, 2009~Yes~RX~ALLOS THERAPEUTICS INC
GADOBUTROL~SOLUTION;INTRAVENOUS~GADAVIST~BAYER HLTHCARE~1.20944GM/2ML (604.72MG/
ML)~N~201277~006~~Dec 18, 2013~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
GADOBUTROL~SOLUTION;INTRAVENOUS~GADAVIST~BAYER HLTHCARE~4.5354GM/7.5ML (604.72MG
/ML)~N~201277~001~~Mar 14, 2011~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ML)~N~201277~002~~Mar 14, 2011~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ML)~N~201277~003~~Mar 14, 2011~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
GADOBUTROL~SOLUTION;INTRAVENOUS~GADAVIST~BAYER HLTHCARE~18.1416GM/30ML (604.72MG
GADOBUTROL~SOLUTION;INTRAVENOUS~GADAVIST~BAYER HLTHCARE~39.3068GM/65ML (604.72MG
ERIBULIN MESYLATE~SOLUTION;INTRAVENOUS~HALAVEN~EISAI INC~1MG/2ML (0.5MG/ML)~N~20
1532~001~~Nov 15, 2010~Yes~RX~EISAI INC
REGADENOSON~SOLUTION;INTRAVENOUS~LEXISCAN~ASTELLAS~0.4MG/5ML (0.08MG/ML)~N~02216
1~001~~Apr 10, 2008~Yes~RX~ASTELLAS PHARMA US INC
FOSPROPOFOL DISODIUM~SOLUTION;INTRAVENOUS~LUSEDRA~EISAI INC~1050MG/30ML (35MG/ML

)~N~022244~001~~Dec 12, 2008~No~DISCN~EISAI INC
MIVACURIUM CHLORIDE~SOLUTION;INTRAVENOUS~MIVACRON~ABBVIE~EQ 2MG BASE/ML (EQ 2MG
BASE/ML) ~N~020098~001~~Jan 22, 1992~No~DISCN~ABBVIE INC
MIVACURIUM CHLORIDE~SOLUTION;INTRAVENOUS~MIVACRON~ABBVIE~EQ 10MG BASE/5ML (EQ 2M
G BASE/ML)~N~020098~004~~Jan 22, 1992~No~RX~ABBVIE INC
MIVACURIUM CHLORIDE~SOLUTION;INTRAVENOUS~MIVACRON~ABBVIE~EQ 20MG BASE/10ML (EQ 2
MG BASE/ML)~N~020098~005~~Jan 22, 1992~Yes~RX~ABBVIE INC
NEOSTIGMINE METHYLSULFATE~SOLUTION;INTRAVENOUS~NEOSTIGMINE METHYLSULFATE~FRESENI
US KABI USA~5MG/10ML (0.5MG/ML)~N~203629~001~~Jan 8, 2015~No~RX~FRESENIUS KABI U
SA LLC
NEOSTIGMINE METHYLSULFATE~SOLUTION;INTRAVENOUS~NEOSTIGMINE METHYLSULFATE~FRESENI
US KABI USA~10MG/10ML (1MG/ML)~N~203629~002~~Jan 8, 2015~No~RX~FRESENIUS KABI US
A LLC
FLORBETABEN F-18~SOLUTION;INTRAVENOUS~NEURACEQ~PIRAMAL IMAGING~30ML (1.4-135mCi/
ML)~N~204677~001~~Mar 19, 2014~Yes~RX~PIRAMAL IMAGING SA
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~HIKMA PHARMS~0.002MG/ML (0.002MG/
ML)~N~205917~001~AP~Nov 18, 2014~No~RX~HIKMA PHARMACEUTICALS CO LTD
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~HIKMA PHARMS~0.005MG/ML (0.005MG/
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~HIKMA PHARMS~0.01MG/2ML (0.005MG/
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~HOSPIRA INC~0.002MG/ML (0.002MG/M
L)~N~201657~001~AP~Oct 21, 2014~No~RX~HOSPIRA INC
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~HOSPIRA INC~0.005MG/ML (0.005MG/M
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~HOSPIRA INC~0.01MG/2ML (0.005MG/M
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~SANDOZ CANADA INC~0.002MG/ML (0.0
02MG/ML)~A~091108~001~AP~Jul 27, 2011~No~RX~SANDOZ CANADA INC
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~SANDOZ CANADA INC~0.005MG/ML (0.0
PARICALCITOL~SOLUTION;INTRAVENOUS~PARICALCITOL~SANDOZ CANADA INC~0.01MG/2ML (0.0
SILDENAFIL CITRATE~SOLUTION;INTRAVENOUS~REVATIO~PFIZER~EQ 10MG BASE/12.5ML (EQ 0
.8MG BASE/ML)~N~022473~001~~Nov 18, 2009~Yes~RX~PFIZER INC
SODIUM NITRITE~SOLUTION;INTRAVENOUS~SODIUM NITRITE~HOPE PHARMS~300MG/10ML (30MG/
ML)~N~203922~001~~Feb 14, 2012~Yes~RX~HOPE PHARMACEUTICALS
SODIUM THIOSULFATE~SOLUTION;INTRAVENOUS~SODIUM THIOSULFATE~HOPE PHARMS~12.5GM/50
ML (250MG/ML)~N~203923~001~~Feb 14, 2012~Yes~RX~HOPE PHARMACEUTICALS
SOTALOL HYDROCHLORIDE~SOLUTION;INTRAVENOUS~SOTALOL HYDROCHLORIDE~ACADEMIC PHARMS
~150MG/10ML (15MG/ML)~N~022306~001~~Jul 2, 2009~Yes~RX~ACADEMIC PHARMACEUTICALS
INC
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR~SOLUTION;INTRAVENOUS~TECHNELITE
~LANTHEUS MEDCL~1-20 CI/GENERATOR~N~017771~002~~Feb 12, 2014~Yes~RX~LANTHEUS MED
ICAL IMAGING INC
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR~SOLUTION;INTRAVENOUS~TECHNELITE
~LANTHEUS MEDCL~0.0083-2.7 CI/GENERATOR~N~017771~001~~Approved Prior to Jan 1, 1
982~No~DISCN~LANTHEUS MEDICAL IMAGING INC
TOPOTECAN HYDROCHLORIDE~SOLUTION;INTRAVENOUS~TOPOTECAN~SANDOZ INC~EQ 1MG BASE/ML
(EQ 1MG BASE/ML)~N~200199~001~~Feb 25, 2011~No~DISCN~SANDOZ INC
TOPOTECAN HYDROCHLORIDE~SOLUTION;INTRAVENOUS~TOPOTECAN~SANDOZ INC~EQ 3MG BASE/3M
L (EQ 1MG BASE/ML)~N~200199~002~~Feb 25, 2011~No~DISCN~SANDOZ INC
TOPOTECAN HYDROCHLORIDE~SOLUTION;INTRAVENOUS~TOPOTECAN~SANDOZ INC~EQ 4MG BASE/4M
L (EQ 1MG BASE/ML)~N~200199~003~~Feb 25, 2011~No~DISCN~SANDOZ INC
TOPOTECAN HYDROCHLORIDE~SOLUTION;INTRAVENOUS~TOPOTECAN HYDROCHLORIDE~HOSPIRA INC
~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~N~200582~001~AP~Feb 2, 2011~Yes~RX~HOSPIRA INC
TOPOTECAN HYDROCHLORIDE~SOLUTION;INTRAVENOUS~TOPOTECAN HYDROCHLORIDE~TEVA PHARMS
USA~EQ 4MG BASE/4ML (EQ 1MG BASE/ML)~N~022453~001~AP~Dec 20, 2012~No~RX~TEVA PH
ARMACEUTICALS USA
TEMSIROLIMUS~SOLUTION;INTRAVENOUS~TORISEL~PF PRISM CV~25MG/ML (25MG/ML)~N~022088

~001~~May 30, 2007~Yes~RX~PF PRISM CV
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR~SOLUTION;INTRAVENOUS~ULTRA-TECH
NEKOW FM~MALLINCKRODT~1-19 CI/GENERATOR~N~017243~003~~Feb 18, 2014~Yes~RX~MALLIN
CKRODT MEDICAL INC
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR~SOLUTION;INTRAVENOUS~ULTRA-TECH
NEKOW FM~MALLINCKRODT~0.25-3 CI/GENERATOR~N~017243~002~~Approved Prior to Jan 1,
POLIDOCANOL~SOLUTION;INTRAVENOUS~VARITHENA~PROVENSIS~180MG/18ML (10MG/ML)~N~2050
98~001~~Nov 25, 2013~Yes~RX~PROVENSIS LTD
VERAPAMIL HYDROCHLORIDE~SOLUTION;INTRAVENOUS~VERAPAMIL HYDROCHLORIDE~HOSPIRA~10M
G/4ML (2.5MG/ML)~A~070738~001~AP~May 6, 1987~Yes~RX~HOSPIRA INC
VERAPAMIL HYDROCHLORIDE~SOLUTION;INTRAVENOUS~VERAPAMIL HYDROCHLORIDE~HOSPIRA~5MG
/2ML (2.5MG/ML)~A~075136~001~AP~Oct 20, 1998~Yes~RX~HOSPIRA INC
VERAPAMIL HYDROCHLORIDE~SOLUTION;INTRAVENOUS~VERAPAMIL HYDROCHLORIDE~HOSPIRA~5MG
/2ML (2.5MG/ML)~A~070737~001~AP~May 6, 1987~Yes~RX~HOSPIRA INC
VERAPAMIL HYDROCHLORIDE~SOLUTION;INTRAVENOUS~VERAPAMIL HYDROCHLORIDE~HOSPIRA~10M
G/4ML (2.5MG/ML)~A~070737~002~AP~May 6, 1987~Yes~RX~HOSPIRA INC
LACOSAMIDE~SOLUTION;INTRAVENOUS~VIMPAT~UCB INC~200MG/20ML (10MG/ML)~N~022254~001
~~Oct 28, 2008~Yes~RX~UCB INC
RADIUM RA-223 DICHLORIDE~SOLUTION;INTRAVENOUS~XOFIGO~BAYER HLTHCARE~162mCi/6ML (
27mCi/ML)~N~203971~001~~May 15, 2013~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
PARICALCITOL~SOLUTION;INTRAVENOUS~ZEMPLAR~ABBVIE~0.002MG/ML (0.002MG/ML)~N~02081
9~002~AP~Feb 1, 2000~Yes~RX~ABBVIE INC
PARICALCITOL~SOLUTION;INTRAVENOUS~ZEMPLAR~ABBVIE~0.005MG/ML (0.005MG/ML)~N~02081
9~001~AP~Apr 17, 1998~Yes~RX~ABBVIE INC
PARICALCITOL~SOLUTION;INTRAVENOUS~ZEMPLAR~ABBVIE~0.01MG/2ML (0.005MG/ML)~N~02081
9~003~AP~Feb 1, 2000~Yes~RX~ABBVIE INC
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR~SOLUTION;INTRAVENOUS, ORAL~TECH
NETIUM TC 99M GENERATOR~GE HEALTHCARE~68-2703mCi/GENERATOR~N~017693~002~~Dec 13,
2013~Yes~RX~GE HEALTHCARE
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR~SOLUTION;INTRAVENOUS, ORAL~TECH
NETIUM TC 99M GENERATOR~GE HEALTHCARE~830-16600mCi/GENERATOR~N~017693~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
PEGINESATIDE ACETATE~SOLUTION;INTRAVENOUS, SUBCUTANEOUS~OMONTYS~TAKEDA PHARMS US
A~EQ 10MG BASE/ML (EQ 10MG BASE/ML)~N~202799~007~~Mar 27, 2012~No~DISCN~TAKEDA P
PEGINESATIDE ACETATE~SOLUTION;INTRAVENOUS, SUBCUTANEOUS~OMONTYS~TAKEDA PHARMS US
A~EQ 20MG BASE/2ML (EQ 10MG BASE/ML)~N~202799~008~~Mar 27, 2012~No~DISCN~TAKEDA
PEGINESATIDE ACETATE~SOLUTION;INTRAVENOUS, SUBCUTANEOUS~OMONTYS PRESERVATIVE FRE
E~TAKEDA PHARMS USA~EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)~N~202799~001~~Mar 27,
2012~No~DISCN~TAKEDA PHARMACEUTICALS USA INC
IOTHALAMATE MEGLUMINE~SOLUTION;INTRAVESICAL~CYSTO-CONRAY II~LIEBEL-FLARSHEIM~17.
2%~N~017057~002~~Approved Prior to Jan 1, 1982~No~RX~LIEBEL-FLARSHEIM CO LLC
DIMETHYL SULFOXIDE~SOLUTION;INTRAVESICAL~DIMETHYL SULFOXIDE~MYLAN INSTITUTIONAL~

50%~A~076185~001~AT~Nov 29, 2002~No~RX~MYLAN INSTITUTIONAL LLC
DIMETHYL SULFOXIDE~SOLUTION;INTRAVESICAL~RIMSO-50~MYLAN INSTITUTIONAL~50%~N~0177
88~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~MYLAN INSTITUTIONAL LLC
VALRUBICIN~SOLUTION;INTRAVESICAL~VALSTAR PRESERVATIVE FREE~ENDO PHARM~40MG/ML~N~
020892~001~~Sep 25, 1998~Yes~RX~ENDO PHARMACEUTICAL SOLUTIONS INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~SOLUTION;IONTOPHORESIS~IONTOCAINE~IOMED~0.0
1MG/ML;2%~N~020530~001~~Dec 21, 1995~No~DISCN~IOMED INC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE~SOLUTION;IONTOPHORESIS, TOPICAL~LIDOCAINE H
YDROCHLORIDE AND EPINEPHRINE~EMPI~0.01MG/ML;2%~N~021486~001~~Oct 26, 2004~No~DIS
CN~EMPI INC
GLYCINE~SOLUTION;IRRIGATION~AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER~BAXTER HL
THCARE~1.5GM/100ML~N~017865~001~AT~Approved Prior to Jan 1, 1982~No~RX~BAXTER HE
ALTHCARE CORP
CHLORIDE; SODIUM CITRATE~SOLUTION;IRRIGATION~BALANCED SALT~AKORN~0.48MG/ML;0.3M
G/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML~A~075503~001~AT~Sep 27, 2006~No~RX~AKO
RN INC
CHLORIDE; SODIUM CITRATE~SOLUTION;IRRIGATION~BALANCED SALT~B BRAUN~0.48MG/ML;0.
3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML~A~091387~001~AT~Feb 3, 2010~No~RX~B
BRAUN MEDICAL INC
PROPIOLACTONE~SOLUTION;IRRIGATION~BETAPRONE~FOREST LABS~N/A~N~011657~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~FOREST LABORATORIES INC
CHLORIDE; SODIUM CITRATE~SOLUTION;IRRIGATION~BSS~ALCON~0.48MG/ML;0.3MG/ML;0.75M
G/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML~N~020742~001~AT~Dec 10, 1997~Yes~RX~ALCON LABORA
TORIES INC
CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM
CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE~SOLUTION;IRRIGA
TION~BSS PLUS~ALCON~0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;
7.14MG/ML;0.42MG/ML~N~018469~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~ALCON L
ABORATORIES INC
CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM
CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE~SOLUTION;IRRIGA
TION~ENDOSOL EXTRA~AKORN~0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1M
G/ML;7.14MG/ML;0.42MG/ML~N~020079~001~AT~Nov 27, 1991~Yes~RX~AKORN INC
GLYCINE~SOLUTION;IRRIGATION~GLYCINE 1.5% IN PLASTIC CONTAINER~B BRAUN~1.5GM/100M
L~N~016784~001~AT~Approved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
GLYCINE~SOLUTION;IRRIGATION~GLYCINE 1.5% IN PLASTIC CONTAINER~BAXTER HLTHCARE~1.
5GM/100ML~N~018522~001~~Feb 19, 1982~No~DISCN~BAXTER HEALTHCARE CORP
GLYCINE~SOLUTION;IRRIGATION~GLYCINE 1.5% IN PLASTIC CONTAINER~HOSPIRA~1.5GM/100M
L~N~017633~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
GLYCINE~SOLUTION;IRRIGATION~GLYCINE 1.5% IN PLASTIC CONTAINER~HOSPIRA~1.5GM/100M
L~N~018315~001~AT~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE~SOLUTION;IRRIGATION~IRRIGATING SO
LUTION G IN PLASTIC CONTAINER~BAXTER HLTHCARE~3.24GM/100ML;380MG/100ML;430MG/100
ML~N~018519~001~~Jun 22, 1982~No~DISCN~BAXTER HEALTHCARE CORP
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE~SOLUTION;I
RRIGATION~LACTATED RINGER'S IN PLASTIC CONTAINER~B BRAUN~20MG/100ML;30MG/100ML;6
00MG/100ML;310MG/100ML~N~018681~001~AT~Dec 27, 1982~Yes~RX~B BRAUN MEDICAL INC
RRIGATION~LACTATED RINGER'S IN PLASTIC CONTAINER~BAXTER HLTHCARE~20MG/100ML;30MG
/100ML;600MG/100ML;310MG/100ML~N~018494~001~AT~Feb 19, 1982~No~RX~BAXTER HEALTHC
ARE CORP
/100ML;600MG/100ML;310MG/100ML~N~018921~001~AT~Apr 3, 1984~Yes~RX~BAXTER HEALTHC
ARE CORP

/100ML;600MG/100ML;310MG/100ML~N~019933~001~AT~Aug 29, 1989~Yes~RX~BAXTER HEALTH
CARE CORP
RRIGATION~LACTATED RINGER'S IN PLASTIC CONTAINER~HOSPIRA~20MG/100ML;30MG/100ML;6
00MG/100ML;310MG/100ML~N~019416~001~AT~Jan 17, 1986~Yes~RX~HOSPIRA INC
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORID
E; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE~SOLUTION;IRRIGATION~NAV
STEL~ALCON PHARMS LTD~0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/M
L;7.14MG/ML;0.42MG/ML~N~022193~001~~Jul 24, 2008~Yes~RX~ALCON PHARMACEUTICALS LT
D
NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION;IRRIGATION~NEOMYCIN AND POLYMYXIN
B SULFATE~WATSON LABS~EQ 40MG BASE/ML;200,000 UNITS/ML~A~062664~001~AT~Apr 8, 1
B SULFATE~X GEN PHARMS~EQ 40MG BASE/ML;200,000 UNITS/ML~A~065106~001~AT~Jan 31,
2006~No~RX~X GEN PHARMACEUTICALS INC
B SULFATE~X GEN PHARMS~EQ 40MG BASE/ML;200,000 UNITS/ML~A~065108~001~AT~Jan 31,
2006~No~RX~X GEN PHARMACEUTICALS INC
NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SOLUTION;IRRIGATION~NEOSPORIN G.U. IRRIGAN
T~MONARCH PHARMS~EQ 40MG BASE/ML;200,000 UNITS/ML~A~060707~001~AT~Approved Prior
to Jan 1, 1982~Yes~RX~MONARCH PHARMACEUTICALS INC
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE~SOLUTION;IRRIGATION~OMIDRIA~
OMEROS~EQ 4.24MG BASE/ML;EQ 12.4MG BASE/ML~N~205388~001~~May 30, 2014~Yes~RX~OME
ROS CORP
GLUCONATE~SOLUTION;IRRIGATION~PHYSIOLYTE IN PLASTIC CONTAINER~B BRAUN~30MG/100ML
;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML~N~019024~001~~Jun 8, 1984~No~RX~
B BRAUN MEDICAL INC
GLUCONATE~SOLUTION;IRRIGATION~PHYSIOSOL IN PLASTIC CONTAINER~HOSPIRA~30MG/100ML;
37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML~N~017637~002~~Jul 8, 1982~No~RX~H
OSPIRA INC
GLUCONATE~SOLUTION;IRRIGATION~PHYSIOSOL IN PLASTIC CONTAINER~HOSPIRA INC~14MG/10
0ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML~N~018406~001~~Approved Prior
to Jan 1, 1982~No~DISCN~HOSPIRA INC
GLUCONATE~SOLUTION;IRRIGATION~PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER~HOSPIRA INC~
30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML~N~018406~002~~Jul 8, 1
CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE~SOLUTION;IRRIGATION~RENACIDIN~U
NITED GUARDIAN~6.602GM/100ML;198MG/100ML;3.177GM/100ML~N~019481~001~~Oct 2, 1990
~Yes~RX~UNITED GUARDIAN INC
MANNITOL~SOLUTION;IRRIGATION~RESECTISOL~B BRAUN~5GM/100ML~N~016704~002~~Approved
MANNITOL~SOLUTION;IRRIGATION~RESECTISOL IN PLASTIC CONTAINER~B BRAUN~5GM/100ML~N
~016772~002~~Approved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE~SOLUTION;IRRIGATION~RINGER
'S IN PLASTIC CONTAINER~ABBOTT~33MG/100ML;30MG/100ML;860MG/100ML~N~018462~001~~A
S DIV
'S IN PLASTIC CONTAINER~B BRAUN~33MG/100ML;30MG/100ML;860MG/100ML~N~018156~001~A
T~Approved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
'S IN PLASTIC CONTAINER~BAXTER HLTHCARE~33MG/100ML;30MG/100ML;860MG/100ML~N~0184
95~001~AT~Feb 19, 1982~No~RX~BAXTER HEALTHCARE CORP
'S IN PLASTIC CONTAINER~HOSPIRA~33MG/100ML;30MG/100ML;860MG/100ML~N~017635~001~A

T~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
SODIUM CHLORIDE~SOLUTION;IRRIGATION~SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~B
AXTER HLTHCARE~450MG/100ML~N~017864~001~~Approved Prior to Jan 1, 1982~No~DISCN~
AXTER HLTHCARE~450MG/100ML~N~018497~001~~Feb 19, 1982~No~DISCN~BAXTER HEALTHCARE
CORP
SODIUM CHLORIDE~SOLUTION;IRRIGATION~SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~H
OSPIRA~450MG/100ML~N~017670~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA
WORLDWIDE, INC
SODIUM CHLORIDE~SOLUTION;IRRIGATION~SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER~H
OSPIRA~450MG/100ML~N~018380~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA
WORLDWIDE, INC
BRAUN~900MG/100ML~N~016733~001~AT~Approved Prior to Jan 1, 1982~No~RX~B BRAUN ME
DICAL INC
SODIUM CHLORIDE~SOLUTION;IRRIGATION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~BA
XTER HLTHCARE~900MG/100ML~N~017427~001~AT~Approved Prior to Jan 1, 1982~No~RX~BA
SODIUM CHLORIDE~SOLUTION;IRRIGATION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~BA
XTER HLTHCARE~900MG/100ML~N~017867~001~AT~Approved Prior to Jan 1, 1982~No~RX~BA
SODIUM CHLORIDE~SOLUTION;IRRIGATION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~HO
SPIRA~900MG/100ML~N~017514~001~AT~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA IN
C
SODIUM CHLORIDE~SOLUTION;IRRIGATION~SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER~HO
SPIRA~900MG/100ML~N~018314~001~AT~Approved Prior to Jan 1, 1982~No~RX~HOSPIRA IN
C
SODIUM CHLORIDE~SOLUTION;IRRIGATION~SODIUM CHLORIDE IN PLASTIC CONTAINER~MILES~9
00MG/100ML~N~018247~001~~Approved Prior to Jan 1, 1982~No~DISCN~MILES LABORATORI
ES INC
SORBITOL~SOLUTION;IRRIGATION~SORBITOL 3% IN PLASTIC CONTAINER~BAXTER HLTHCARE~3G
M/100ML~N~017863~001~~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
SORBITOL~SOLUTION;IRRIGATION~SORBITOL 3% IN PLASTIC CONTAINER~BAXTER HLTHCARE~3G
M/100ML~N~018512~001~~May 27, 1982~No~DISCN~BAXTER HEALTHCARE CORP
SORBITOL~SOLUTION;IRRIGATION~SORBITOL 3.3% IN PLASTIC CONTAINER~B BRAUN~3.3GM/10
0ML~N~016741~001~~Approved Prior to Jan 1, 1982~No~RX~B BRAUN MEDICAL INC
MANNITOL; SORBITOL~SOLUTION;IRRIGATION~SORBITOL-MANNITOL~HOSPIRA~540MG/100ML;2.7
GM/100ML~A~080224~001~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA INC
MANNITOL; SORBITOL~SOLUTION;IRRIGATION~SORBITOL-MANNITOL IN PLASTIC CONTAINER~HO
SPIRA~540MG/100ML;2.7GM/100ML~N~017636~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~HOSPIRA INC
MANNITOL; SORBITOL~SOLUTION;IRRIGATION~SORBITOL-MANNITOL IN PLASTIC CONTAINER~HO
SPIRA~540MG/100ML;2.7GM/100ML~N~018316~001~~Approved Prior to Jan 1, 1982~No~RX~
HOSPIRA INC
GLUCONATE~SOLUTION;IRRIGATION~SYNOVALYTE IN PLASTIC CONTAINER~BAXTER HLTHCARE~30
MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML~N~019326~001~~Jan 25, 19
MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CH
LORIDE; SODIUM PHOSPHATE~SOLUTION;IRRIGATION~TIS-U-SOL~BAXTER HLTHCARE~20MG/100M
L;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML~N~018508~001~AT~Feb 19, 1982~
No~RX~BAXTER HEALTHCARE CORP
MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CH
LORIDE; SODIUM PHOSPHATE~SOLUTION;IRRIGATION~TIS-U-SOL IN PLASTIC CONTAINER~BAXT
ER HLTHCARE~20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML~N~018336
~001~AT~Approved Prior to Jan 1, 1982~No~RX~BAXTER HEALTHCARE CORP
CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE~SOLUTION;IRRIGATION~UROLOGIC G IN
PLASTIC CONTAINER~HOSPIRA~3.24GM/100ML;380MG/100ML;430MG/100ML~N~018904~001~~Ma
y 27, 1983~No~DISCN~HOSPIRA INC

ACETIC ACID, GLACIAL~SOLUTION;IRRIGATION, URETHRAL~ACETIC ACID 0.25% IN PLASTIC
CONTAINER~B BRAUN~250MG/100ML~N~018161~001~AT~Approved Prior to Jan 1, 1982~No~R
CONTAINER~BAXTER HLTHCARE~250MG/100ML~N~018523~001~AT~Feb 19, 1982~No~RX~BAXTER
HEALTHCARE CORP
CONTAINER~HOSPIRA~250MG/100ML~N~017656~001~AT~Approved Prior to Jan 1, 1982~No~R
X~HOSPIRA INC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSCAN~ASTELLAS~60MG/20ML (3MG/ML)~N~020059~
001~AP~May 18, 1995~Yes~RX~ASTELLAS PHARMA US INC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSCAN~ASTELLAS~90MG/30ML (3MG/ML)~N~020059~
002~AP~May 18, 1995~Yes~RX~ASTELLAS PHARMA US INC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~AKORN~60MG/20ML (3MG/ML)~A~090450~001
~AP~Oct 2, 2014~No~RX~AKORN INC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~AKORN~90MG/30ML (3MG/ML)~A~090450~002
~AP~Oct 2, 2014~No~RX~AKORN INC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~EMCURE PHARMS LTD~60MG/20ML (3MG/ML)~
A~202313~001~AP~Sep 15, 2014~No~RX~EMCURE PHARMACEUTICALS LTD
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~EMCURE PHARMS LTD~90MG/30ML (3MG/ML)~
A~202313~002~AP~Sep 15, 2014~No~RX~EMCURE PHARMACEUTICALS LTD
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~HOSPIRA INC~60MG/20ML (3MG/ML)~A~2038
83~001~AP~Mar 24, 2014~No~RX~HOSPIRA INC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~HOSPIRA INC~90MG/30ML (3MG/ML)~A~2038
83~002~AP~Mar 24, 2014~No~RX~HOSPIRA INC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~SAGENT STRIDES~60MG/20ML (3MG/ML)~A~0
90212~001~AP~Mar 28, 2014~No~RX~SAGENT STRIDES LLC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~SAGENT STRIDES~90MG/30ML (3MG/ML)~A~0
90212~002~AP~Mar 28, 2014~No~RX~SAGENT STRIDES LLC
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~TEVA PHARMS USA~60MG/20ML (3MG/ML)~A~
077425~001~AP~Aug 29, 2013~No~RX~TEVA PHARMACEUTICALS USA
ADENOSINE~SOLUTION;IV (INFUSION)~ADENOSINE~TEVA PHARMS USA~90MG/30ML (3MG/ML)~A~
077425~002~AP~Aug 29, 2013~No~RX~TEVA PHARMACEUTICALS USA
SODIUM BENZOATE; SODIUM PHENYLACETATE~SOLUTION;IV (INFUSION)~AMMONUL~MEDICIS~10%
;10% (5GM/50ML;5GM/50ML)~N~020645~001~~Feb 17, 2005~Yes~RX~MEDICIS PHARMACEUTICA
L CORP
ARGATROBAN~SOLUTION;IV (INFUSION)~ARGATROBAN IN DEXTROSE~SANDOZ~125MG/125ML (1MG
/ML)~N~201743~001~~May 9, 2011~No~DISCN~SANDOZ INC
EPINEPHRINE HYDROCHLORIDE~SOLUTION;IV (INFUSION)~EPINEPHRINE~BELCHER PHARMS LLC~
EQ 1MG BASE/ML (EQ 1MG BASE/ML)~N~205029~001~~Jul 29, 2014~No~RX~BELCHER PHARMAC
EUTICALS LLC
LEVOLEUCOVORIN CALCIUM~SOLUTION;IV (INFUSION)~FUSILEV~SPECTRUM PHARMS~EQ 175MG B
ASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was n
ot discontinued or withdrawn for safety or efficacy reasons**~N~020140~002~~Apr
29, 2011~No~DISCN~SPECTRUM PHARMACEUTICALS INC
LEVOLEUCOVORIN CALCIUM~SOLUTION;IV (INFUSION)~FUSILEV~SPECTRUM PHARMS~EQ 250MG B
ASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not
discontinued or withdrawn for safety or efficacy reasons**~N~020140~003~~Apr 29
, 2011~No~DISCN~SPECTRUM PHARMACEUTICALS INC
CABAZITAXEL~SOLUTION;IV (INFUSION)~JEVTANA KIT~SANOFI AVENTIS US~60MG/1.5ML (40M
G/ML)~N~201023~001~~Jun 17, 2010~Yes~RX~SANOFI AVENTIS US INC
LEVOLEUCOVORIN CALCIUM~SOLUTION;IV (INFUSION)~LEVOLEUCOVORIN CALCIUM~SANDOZ~EQ 1
75MG BASE/17.5ML (EQ 10MG BASE/ML)~A~203563~001~~Mar 9, 2015~No~RX~SANDOZ INC
LEVOLEUCOVORIN CALCIUM~SOLUTION;IV (INFUSION)~LEVOLEUCOVORIN CALCIUM~SANDOZ~EQ 2
50MG BASE/25ML (EQ 10MG BASE/ML)~A~203563~002~~Mar 9, 2015~No~RX~SANDOZ INC
POSACONAZOLE~SOLUTION;IV (INFUSION)~NOXAFIL~MERCK SHARP DOHME~300MG/16.7ML (18MG
/ML)~N~205596~001~~Mar 13, 2014~Yes~RX~MERCK SHARP AND DOHME CORP
ACETAMINOPHEN~SOLUTION;IV (INFUSION)~OFIRMEV~CADENCE PHARMS~1000MG/100ML (10MG/M
L)~N~022450~001~~Nov 2, 2010~Yes~RX~CADENCE PHARMACEUTICALS INC
PHENYLEPHRINE HYDROCHLORIDE~SOLUTION;IV (INFUSION)~PHENYLEPHRINE HYDROCHLORIDE~W

EST WARD PHARM CORP~10MG/ML (10MG/ML)~N~203826~001~~Dec 20, 2012~Yes~RX~WEST WAR
D PHARMACEUTICAL CORP
PERAMIVIR~SOLUTION;IV (INFUSION)~RAPIVAB~BIOCRYST~200MG/20ML (10MG/ML)~N~206426~
001~~Dec 19, 2014~Yes~RX~BIOCRYST PHARMACEUTICALS INC
BENDAMUSTINE HYDROCHLORIDE~SOLUTION;IV (INFUSION)~TREANDA~CEPHALON~45MG/0.5ML (9
0MG/ML)~N~022249~003~~Sep 13, 2013~Yes~RX~CEPHALON INC
BENDAMUSTINE HYDROCHLORIDE~SOLUTION;IV (INFUSION)~TREANDA~CEPHALON~180MG/2ML (90
MG/ML)~N~022249~004~~Sep 13, 2013~Yes~RX~CEPHALON INC
FERRIC PYROPHOSPHATE CITRATE~SOLUTION;IV (INFUSION)~TRIFERIC~ROCKWELL MEDICAL IN
C~27.2MG IRON/5ML (5.44MG IRON/ML)~N~206317~001~~Jan 23, 2015~Yes~RX~ROCKWELL ME
DICAL INC
VASOPRESSIN~SOLUTION;IV (INFUSION)~VASOSTRICT~PAR STERILE PRODUCTS~20UNITS/ML (2
0UNITS/ML)~N~204485~001~~Apr 17, 2014~Yes~RX~PAR STERILE PRODUCTS LLC
PHENYLEPHRINE HYDROCHLORIDE~SOLUTION;IV (INFUSION)~VAZCULEP~ECLAT PHARMS LLC~10M
G/ML (10MG/ML)~N~204300~001~~Jun 27, 2014~No~RX~ECLAT PHARMACEUTICALS LLC
PHENYLEPHRINE HYDROCHLORIDE~SOLUTION;IV (INFUSION)~VAZCULEP~ECLAT PHARMS LLC~50M
G/5ML (10MG/ML)~N~204300~002~~Jun 27, 2014~No~RX~ECLAT PHARMACEUTICALS LLC
PHENYLEPHRINE HYDROCHLORIDE~SOLUTION;IV (INFUSION)~VAZCULEP~ECLAT PHARMS LLC~100
MG/10ML (10MG/ML)~N~204300~003~~Jun 27, 2014~Yes~RX~ECLAT PHARMACEUTICALS LLC
DESMOPRESSIN ACETATE~SOLUTION;NASAL~CONCENTRAID~FERRING~0.01%~N~019776~001~~Dec
26, 1990~No~DISCN~FERRING PHARMACEUTICALS INC
DESMOPRESSIN ACETATE~SOLUTION;NASAL~DDAVP~FERRING PHARMS INC~0.01%~N~017922~001~
AB~Approved Prior to Jan 1, 1982~Yes~RX~FERRING PHARMACEUTICALS INC
DESMOPRESSIN ACETATE~SOLUTION;NASAL~DESMOPRESSIN ACETATE~SUN PHARM INDS~0.01%~A~
077212~001~AB~Apr 12, 2012~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
LYPRESSIN~SOLUTION;NASAL~DIAPID~NOVARTIS~0.185MG/ML~N~016755~001~~Approved Prior
to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
OXYTOCIN~SOLUTION;NASAL~SYNTOCINON~RETROPHIN INC~40USP UNITS/ML~N~012285~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~RETROPHIN INC
TETRAHYDROZOLINE HYDROCHLORIDE~SOLUTION;NASAL~TYZINE~FOUGERA PHARMS~0.05%~A~0865
76~002~~Approved Prior to Jan 1, 1982~Yes~RX~FOUGERA PHARMACEUTICALS INC
TETRAHYDROZOLINE HYDROCHLORIDE~SOLUTION;NASAL~TYZINE~FOUGERA PHARMS~0.1%~A~08657
6~001~~Approved Prior to Jan 1, 1982~No~RX~FOUGERA PHARMACEUTICALS INC
PILOCARPINE HYDROCHLORIDE~SOLUTION;OPHTHALMIC~ISOPTO CARPINE~ALCON RES~1%~N~2008
90~001~~Jun 22, 2010~No~RX~ALCON RESEARCH LTD
90~002~~Jun 22, 2010~No~RX~ALCON RESEARCH LTD
90~003~~Jun 22, 2010~Yes~RX~ALCON RESEARCH LTD
TRYPAN BLUE~SOLUTION;OPHTHALMIC~MEMBRANEBLUE~DORC~0.15%~N~022278~001~~Feb 20, 20
09~Yes~RX~DORC INTERNATIONAL BV
PURIFIED WATER~SOLUTION;OPHTHALMIC~PUR-WASH~NIAGARA PHARMS~98.3%~N~022305~001~~S
ep 1, 2011~Yes~OTC~NIAGARA PHARMACEUTICALS INC
TRYPAN BLUE~SOLUTION;OPHTHALMIC~VISIONBLUE~DORC~0.06%~N~021670~001~~Dec 16, 2004
~Yes~RX~DORC INTERNATIONAL BV
ARIPIPRAZOLE~SOLUTION;ORAL~ABILIFY~OTSUKA~1MG/ML~N~021713~001~~Dec 10, 2004~Yes~
RX~OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC
ACETAMINOPHEN; CODEINE PHOSPHATE~SOLUTION;ORAL~ACETAMINOPHEN AND CODEINE PHOSPHA
TE~ACTAVIS MID ATLANTIC~120MG/5ML;12MG/5ML~A~085861~001~~Approved Prior to Jan 1
, 1982~No~DISCN~ACTAVIS MID ATLANTIC LLC
TE~DAVA PHARMS INC~120MG/5ML;12MG/5ML~A~040098~001~~Sep 20, 1996~No~DISCN~DAVA P
HARMACEUTICALS INC
TE~HI TECH PHARMA~120MG/5ML;12MG/5ML~A~040119~001~AA~Apr 26, 1996~No~RX~HI TECH
PHARMACAL CO INC
TE~MIKART~120MG/5ML;12MG/5ML~A~089450~001~AA~Oct 27, 1992~No~RX~MIKART INC
TE~PHARM ASSOC~120MG/5ML;12MG/5ML~A~087508~001~AA~Approved Prior to Jan 1, 1982~

Yes~RX~PHARMACEUTICAL ASSOCIATES INC
TE~ROXANE~120MG/5ML;12MG/5ML~A~086366~001~~Approved Prior to Jan 1, 1982~No~DISC
TE~VINTAGE PHARMS~120MG/5ML;12MG/5ML~A~091238~001~AA~Nov 10, 2011~No~RX~VINTAGE
PHARMACEUTICALS INC
TE~WOCKHARDT~120MG/5ML;12MG/5ML~A~087006~001~AA~Approved Prior to Jan 1, 1982~No
~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
THEOPHYLLINE~SOLUTION;ORAL~AEROLATE~FLEMING PHARMS~150MG/15ML~A~089141~001~~Dec
3, 1986~No~DISCN~FLEMING AND CO PHARMACEUTICALS INC
AMPRENAVIR~SOLUTION;ORAL~AGENERASE~GLAXOSMITHKLINE~15MG/ML **Federal Register de
y reasons**~N~021039~001~~Apr 15, 1999~No~DISCN~GLAXOSMITHKLINE
ALENDRONATE SODIUM~SOLUTION;ORAL~ALENDRONATE SODIUM~ROXANE~EQ 70MG BASE/75ML~A~0
90520~001~AA~Feb 25, 2013~No~RX~ROXANE LABORATORIES INC
ALPRAZOLAM~SOLUTION;ORAL~ALPRAZOLAM~ROXANE~0.5MG/5ML~A~074314~001~~Oct 31, 1993~
No~DISCN~ROXANE LABORATORIES INC
AMINOPHYLLINE~SOLUTION;ORAL~AMINOPHYLLINE~MORTON GROVE~105MG/5ML~A~088156~001~~D
ec 5, 1983~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
AMINOPHYLLINE~SOLUTION;ORAL~AMINOPHYLLINE~ROXANE~105MG/5ML~A~088126~001~~Aug 19,
1983~No~DISCN~ROXANE LABORATORIES INC
AMINOPHYLLINE~SOLUTION;ORAL~AMINOPHYLLINE DYE FREE~ACTAVIS MID ATLANTIC~105MG/5M
L~A~087727~001~~Apr 16, 1982~No~DISCN~ACTAVIS MID ATLANTIC LLC
TIPRANAVIR~SOLUTION;ORAL~APTIVUS~BOEHRINGER INGELHEIM~100MG/ML~N~022292~001~~Jun
23, 2008~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
DONEPEZIL HYDROCHLORIDE~SOLUTION;ORAL~ARICEPT~EISAI INC~5MG/5ML~N~021719~001~~Oc
t 18, 2004~No~DISCN~EISAI INC
NORTRIPTYLINE HYDROCHLORIDE~SOLUTION;ORAL~AVENTYL ~RANBAXY~EQ 10MG BASE/5ML **Fe
safety or efficacy reasons**~N~014685~001~~Approved Prior to Jan 1, 1982~No~DISC
N~RANBAXY PHARMACEUTICALS INC
NIZATIDINE~SOLUTION;ORAL~AXID~BRAINTREE~15MG/ML~N~021494~001~AA~May 25, 2004~Yes
~RX~BRAINTREE LABORATORIES INC
ENTECAVIR~SOLUTION;ORAL~BARACLUDE~BRISTOL MYERS SQUIBB~0.05MG/ML~N~021798~001~~M
ar 29, 2005~Yes~RX~BRISTOL MYERS SQUIBB
DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE~SOLUTION;ORAL~BENYL
IN~PARKE DAVIS~12.5MG/5ML;30MG/5ML~N~019014~001~~Jun 11, 1985~No~DISCN~PARKE DAV
IS DIV WARNER LAMBERT CO
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~SOLUTION;ORAL~BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE~MIKART~325MG/15ML;50MG/15ML;40MG/15ML~A~040387~001~~Jan 31, 2003~Yes~RX
~MIKART INC
CAFFEINE CITRATE~SOLUTION;ORAL~CAFCIT~EUROHLTH INTL SARL~EQ 30MG BASE/3ML (EQ 10
MG BASE/ML)~N~020793~002~AA~Apr 12, 2000~Yes~RX~EUROHEALTH INTERNATIONAL SARL
CAFFEINE CITRATE~SOLUTION;ORAL~CAFFEINE CITRATE~EXELA PHARMA SCS LLC~EQ 30MG BAS
E/3ML (EQ 10MG BASE/ML)~A~077304~001~AA~Sep 21, 2006~No~RX~EXELA PHARMA SCIENCES
LLC
CAFFEINE CITRATE~SOLUTION;ORAL~CAFFEINE CITRATE~FRESENIUS KABI USA~EQ 30MG BASE/
3ML (EQ 10MG BASE/ML)~A~078002~001~AA~Jan 31, 2008~No~RX~FRESENIUS KABI USA LLC
CAFFEINE CITRATE~SOLUTION;ORAL~CAFFEINE CITRATE~LUITPOLD~EQ 30MG BASE/3ML (EQ 10
MG BASE/ML)~A~090064~001~AA~Nov 20, 2009~No~RX~LUITPOLD PHARMACEUTICALS INC
CAFFEINE CITRATE~SOLUTION;ORAL~CAFFEINE CITRATE~SAGENT PHARMS~EQ 30MG BASE/3ML (
EQ 10MG BASE/ML)~A~091102~001~AA~Aug 29, 2012~No~RX~SAGENT PHARMACEUTICALS INC
CAFFEINE CITRATE~SOLUTION;ORAL~CAFFEINE CITRATE~SUN PHARMA GLOBAL~EQ 30MG BASE/3
ML (EQ 10MG BASE/ML)~A~090357~001~AA~Sep 30, 2009~No~RX~SUN PHARMA GLOBAL FZE
CALCITRIOL~SOLUTION;ORAL~CALCITRIOL~ROXANE~1MCG/ML~A~076242~001~AA~Jul 18, 2003~
No~RX~ROXANE LABORATORIES INC
MEPENZOLATE BROMIDE~SOLUTION;ORAL~CANTIL~SANOFI AVENTIS US~25MG/5ML~N~010679~004
~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC

CARBINOXAMINE MALEATE~SOLUTION;ORAL~CARBINOXAMINE MALEATE~CYPRESS PHARM~4MG/5ML~
A~090418~001~AA~May 4, 2010~No~RX~CYPRESS PHARMACEUTICAL INC
CARBINOXAMINE MALEATE~SOLUTION;ORAL~CARBINOXAMINE MALEATE~MIKART~4MG/5ML~A~04045
8~001~AA~Apr 25, 2003~Yes~RX~MIKART INC
CARBINOXAMINE MALEATE~SOLUTION;ORAL~CARBINOXAMINE MALEATE~VINTAGE PHARMS~4MG/5ML
~A~040814~001~AA~Feb 26, 2008~No~RX~VINTAGE PHARMACEUTICALS
LEVOCARNITINE~SOLUTION;ORAL~CARNITOR~SIGMA TAU~1GM/10ML~N~018948~002~~Apr 27, 19
88~No~DISCN~SIGMA TAU PHARMACEUTICALS INC
LEVOCARNITINE~SOLUTION;ORAL~CARNITOR~SIGMA TAU~1GM/10ML~N~019257~001~AA~Apr 10,
1986~Yes~RX~SIGMA TAU PHARMACEUTICALS INC
LEVOCARNITINE~SOLUTION;ORAL~CARNITOR SF~SIGMA TAU~1GM/10ML~N~019257~002~AA~Mar 2
8, 2007~No~RX~SIGMA TAU PHARMACEUTICALS INC
CITALOPRAM HYDROBROMIDE~SOLUTION;ORAL~CELEXA~FOREST LABS~EQ 10MG BASE/5ML **Fede
fety or efficacy reasons**~N~021046~001~~Dec 22, 1999~No~DISCN~FOREST LABORATORI
ES INC
OXTRIPHYLLINE~SOLUTION;ORAL~CHOLEDYL~PARKE DAVIS~100MG/5ML~N~009268~012~~Nov 27,
LACTULOSE~SOLUTION;ORAL~CHRONULAC~SANOFI AVENTIS US~10GM/15ML~N~017884~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
BENTIROMIDE~SOLUTION;ORAL~CHYMEX~SAVAGE LABS~500MG/7.5ML~N~018366~001~~Dec 29, 1
983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~CIMETIDINE HYDROCHLORIDE~ACTAVIS MID ATLA
NTIC~EQ 300MG BASE/5ML~A~074176~001~~Jun 1, 1994~No~DISCN~ACTAVIS MID ATLANTIC L
LC
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~CIMETIDINE HYDROCHLORIDE~ANI PHARMS INC~E
Q 300MG BASE/5ML~A~074610~001~AA~Sep 26, 1996~No~RX~ANI PHARMACEUTICALS INC
Q 300MG BASE/5ML~A~074859~001~~Jul 9, 1998~No~DISCN~ANI PHARMACEUTICALS INC
Q 300MG BASE/5ML~A~075110~001~~Jun 18, 1998~No~DISCN~ANI PHARMACEUTICALS INC
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~CIMETIDINE HYDROCHLORIDE~APOTEX INC~EQ 30
0MG BASE/5ML~A~075560~001~~Mar 15, 2000~No~DISCN~APOTEX INC
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~CIMETIDINE HYDROCHLORIDE~CYCLE PHARMS LTD
~EQ 300MG BASE/5ML~A~074541~001~~Aug 5, 1997~No~DISCN~CYCLE PHARMACEUTICALS LTD
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~CIMETIDINE HYDROCHLORIDE~HI TECH PHARMA~E
Q 300MG BASE/5ML~A~074664~001~AA~Oct 28, 1997~Yes~RX~HI TECH PHARMACAL CO INC
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~CIMETIDINE HYDROCHLORIDE~PHARM ASSOC~EQ 3
00MG BASE/5ML~A~074553~001~AA~Jan 27, 1997~No~RX~PHARMACEUTICAL ASSOC INC DIV BE
ACH PRODUCTS
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~CIMETIDINE HYDROCHLORIDE~VINTAGE PHARMS L
LC~EQ 300MG BASE/5ML~A~074251~001~~Dec 22, 1994~No~DISCN~VINTAGE PHARMACEUTICALS
LLC
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~CIMETIDINE HYDROCHLORIDE~WOCKHARDT~EQ 300
MG BASE/5ML~A~074757~001~AA~Oct 17, 1997~No~RX~WOCKHARDT EU OPERATIONS (SWISS) A
G
CITALOPRAM HYDROBROMIDE~SOLUTION;ORAL~CITALOPRAM HYDROBROMIDE~APOTEX INC~EQ 10MG
BASE/5ML~A~077601~001~~Nov 15, 2005~No~DISCN~APOTEX INC
CITALOPRAM HYDROBROMIDE~SOLUTION;ORAL~CITALOPRAM HYDROBROMIDE~AUROBINDO PHARMA L
TD~EQ 10MG BASE/5ML~A~077812~001~AA~Aug 28, 2006~No~RX~AUROBINDO PHARMA LTD INC
CITALOPRAM HYDROBROMIDE~SOLUTION;ORAL~CITALOPRAM HYDROBROMIDE~ROXANE~EQ 10MG BAS
E/5ML~A~077043~001~AA~Dec 13, 2004~Yes~RX~ROXANE LABORATORIES INC
CITALOPRAM HYDROBROMIDE~SOLUTION;ORAL~CITALOPRAM HYDROBROMIDE~SILARX~EQ 10MG BAS
E/5ML~A~077629~001~AA~Jun 15, 2006~No~RX~SILARX PHARMACEUTICALS INC
DESLORATADINE~SOLUTION;ORAL~CLARINEX~MERCK SHARP DOHME~0.5MG/ML~N~021300~001~~Se
p 1, 2004~Yes~RX~MERCK SHARP AND DOHME CORP
CODEINE SULFATE~SOLUTION;ORAL~CODEINE SULFATE~ROXANE~30MG/5ML~N~202245~001~~Jun
30, 2011~No~DISCN~ROXANE LABORATORIES INC
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~SOLUTION;ORAL~COLONAID~MEDPOINTE P
HARM HLC~0.025MG/5ML;2.5MG/5ML~A~085735~001~~Approved Prior to Jan 1, 1982~No~DI

SCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
LACTULOSE~SOLUTION;ORAL~CONSTILAC~ALRA~10GM/15ML~A~071054~001~AA~Jul 26, 1988~No
~RX~ALRA LABORATORIES INC
LACTULOSE~SOLUTION;ORAL~CONSTULOSE~ACTAVIS MID ATLANTIC~10GM/15ML~A~070288~001~A
A~Aug 15, 1988~Yes~RX~ACTAVIS MID ATLANTIC LLC
GLYCOPYRROLATE~SOLUTION;ORAL~CUVPOSA~MERZ PHARMS~1MG/5ML~N~022571~001~~Jul 28, 2
CYCLOSPORINE~SOLUTION;ORAL~CYCLOSPORINE~ABBVIE~100MG/ML~A~065025~001~AB1~Mar 3,
2000~No~RX~ABBVIE INC
CYCLOSPORINE~SOLUTION;ORAL~CYCLOSPORINE~APOTEX INC~100MG/ML~A~065167~001~~Jan 5,
2005~No~DISCN~APOTEX INC
CYCLOSPORINE~SOLUTION;ORAL~CYCLOSPORINE~IVAX SUB TEVA PHARMS~100MG/ML~A~065078~0
01~AB1~Mar 25, 2005~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CYCLOSPORINE~SOLUTION;ORAL~CYCLOSPORINE~WATSON LABS~100MG/ML~A~065054~001~AB1~De
c 18, 2001~No~RX~WATSON LABORATORIES INC
CYCLOSPORINE~SOLUTION;ORAL~CYCLOSPORINE~WOCKHARDT~100MG/ML~A~065133~001~AB2~Sep
17, 2004~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
DEXAMETHASONE~SOLUTION;ORAL~DEXAMETHASONE~ROXANE~0.5MG/5ML~A~088248~001~~Sep 1,
DEXTROAMPHETAMINE SULFATE~SOLUTION;ORAL~DEXTROAMPHETAMINE SULFATE~OUTLOOK PHARMS
~5MG/5ML~A~040776~001~AA~Jan 29, 2008~Yes~RX~OUTLOOK PHARMACEUTICALS INC
DEXTROAMPHETAMINE SULFATE~SOLUTION;ORAL~DEXTROAMPHETAMINE SULFATE~TRIS PHARMA IN
C~5MG/5ML~A~203644~001~AA~May 29, 2013~No~RX~TRIS PHARMA INC
DIAZEPAM~SOLUTION;ORAL~DIAZEPAM~ROXANE~5MG/5ML~A~070928~001~~Apr 3, 1987~Yes~RX~
HYDROMORPHONE HYDROCHLORIDE~SOLUTION;ORAL~DILAUDID~PURDUE PHARM PRODS~5MG/5ML~N~
019891~001~AA~Dec 7, 1992~Yes~RX~PURDUE PHARMACEUTICAL PRODUCTS LP
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~SOLUTION;ORAL~DIPHENOXYLATE HYDROC
HLORIDE AND ATROPINE SULFATE~ROXANE~0.025MG/5ML;2.5MG/5ML~A~087708~001~AA~May 3,
LACTULOSE~SOLUTION;ORAL~DUPHALAC~SOLVAY~10GM/15ML~A~072372~001~~Mar 22, 1989~No~
EMTRICITABINE~SOLUTION;ORAL~EMTRIVA~GILEAD~10MG/ML~N~021896~001~~Sep 28, 2005~Ye
s~RX~GILEAD SCIENCES INC
LAMIVUDINE~SOLUTION;ORAL~EPIVIR~VIIV HLTHCARE~10MG/ML~N~020596~001~AA~Nov 17, 19
LAMIVUDINE~SOLUTION;ORAL~EPIVIR-HBV~GLAXOSMITHKLINE~5MG/ML~N~021004~001~~Dec 8,
ESCITALOPRAM OXALATE~SOLUTION;ORAL~ESCITALOPRAM OXALATE~AMNEAL PHARMS~EQ 5MG BAS
E/5ML~A~202227~001~AA~Mar 14, 2012~No~RX~AMNEAL PHARMACEUTICALS
ESCITALOPRAM OXALATE~SOLUTION;ORAL~ESCITALOPRAM OXALATE~AUROBINDO PHARMA LTD~EQ
5MG BASE/5ML~A~079062~001~AA~Apr 2, 2012~No~RX~AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE~SOLUTION;ORAL~ESCITALOPRAM OXALATE~HETERO LABS LTD III~EQ 5
MG BASE/5ML~A~202221~001~AA~Jun 12, 2012~No~RX~HETERO LABS LTD UNIT III
ESCITALOPRAM OXALATE~SOLUTION;ORAL~ESCITALOPRAM OXALATE~SILARX PHARMS INC~EQ 5MG
BASE/5ML~A~090477~001~AA~Jun 12, 2013~No~RX~SILARX PHARMACEUTICALS INC
ESCITALOPRAM OXALATE~SOLUTION;ORAL~ESCITALOPRAM OXALATE~TARO~EQ 5MG BASE/5ML~A~0
79121~001~AA~May 3, 2012~No~RX~TARO PHARMACEUTICALS USA INC
LACTULOSE~SOLUTION;ORAL~EVALOSE~TEVA PHARMS~10GM/15ML~A~073497~001~~May 28, 1993
~No~DISCN~TEVA PHARMACEUTICALS USA
RIVASTIGMINE TARTRATE~SOLUTION;ORAL~EXELON~NOVARTIS~EQ 2MG BASE/ML~N~021025~001~
~Apr 21, 2000~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~ACTAVIS MID ATLA
NTIC~EQ 20MG BASE/5ML~A~075690~001~~Jan 31, 2002~No~DISCN~ACTAVIS MID ATLANTIC L
LC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~APOTEX INC~EQ 20
MG BASE/5ML~A~075292~001~~Feb 7, 2002~No~DISCN~APOTEX INC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~AUROBINDO PHARM~
EQ 20MG BASE/5ML~A~079209~001~AA~Mar 20, 2009~No~RX~AUROBINDO PHARMA USA INC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~HI TECH PHARMA~E

Q 20MG BASE/5ML~A~075525~001~~Jun 27, 2002~No~DISCN~HI TECH PHARMACAL CO INC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~LANNETT~EQ 20MG
BASE/5ML~A~076458~001~AA~May 14, 2004~No~RX~LANNETT HOLDINGS INC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~MALLINCKRODT~EQ
20MG BASE/5ML~A~075920~001~AA~Jan 29, 2002~No~RX~MALLINCKRODT INC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~PHARM ASSOC~EQ 2
0MG BASE/5ML~A~076015~001~AA~Jan 30, 2002~Yes~RX~PHARMACEUTICAL ASSOC INC DIV BE
ACH PRODUCTS
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~SILARX~EQ 20MG B
ASE/5ML~A~077849~001~AA~Feb 9, 2007~No~RX~SILARX PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~TEVA~EQ 20MG BAS
E/5ML~A~075506~001~AA~Aug 2, 2001~No~RX~TEVA PHARMACEUTICALS USA INC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~FLUOXETINE HYDROCHLORIDE~WOCKHARDT~EQ 20M
G BASE/5ML~A~075514~001~AA~Aug 29, 2002~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
ALENDRONATE SODIUM~SOLUTION;ORAL~FOSAMAX~MERCK~EQ 70MG BASE/75ML~N~021575~001~AA
~Sep 17, 2003~Yes~RX~MERCK AND CO INC
FUROSEMIDE~SOLUTION;ORAL~FUROSEMIDE~ROXANE~10MG/ML~A~070434~001~AA~Apr 22, 1987~
FUROSEMIDE~SOLUTION;ORAL~FUROSEMIDE~ROXANE~40MG/5ML~A~070433~001~~Apr 22, 1987~N
o~RX~ROXANE LABORATORIES INC
FUROSEMIDE~SOLUTION;ORAL~FUROSEMIDE~WOCKHARDT~10MG/ML~A~070655~001~AA~Oct 2, 198
7~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
GABAPENTIN~SOLUTION;ORAL~GABAPENTIN~ACELLA PHARMS LLC~250MG/5ML~A~076403~001~AA~
May 1, 2012~No~RX~ACELLA PHARMACEUTICALS LLC
GABAPENTIN~SOLUTION;ORAL~GABAPENTIN~AMNEAL PHARMS~250MG/5ML~A~202024~001~AA~Mar
23, 2012~No~RX~AMNEAL PHARMACEUTICALS
GABAPENTIN~SOLUTION;ORAL~GABAPENTIN~HI TECH PHARMA~250MG/5ML~A~078974~001~AA~Feb
GABAPENTIN~SOLUTION;ORAL~GABAPENTIN~TARO~250MG/5ML~A~076672~001~AA~Jul 3, 2013~N
o~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
GALANTAMINE HYDROBROMIDE~SOLUTION;ORAL~GALANTAMINE HYDROBROMIDE~ROXANE~4MG/ML~A~
078185~001~AA~Jan 30, 2009~No~RX~ROXANE LABORATORIES INC
GRANISETRON HYDROCHLORIDE~SOLUTION;ORAL~GRANISOL~PEDIATRX~EQ 2MG BASE/10ML~A~078
334~001~~Feb 28, 2008~No~DISCN~PEDIATRX INC
HALOPERIDOL LACTATE~SOLUTION;ORAL~HALOPERIDOL LACTATE~ACTAVIS MID ATLANTIC~EQ 1M
G BASE/ML~A~074536~001~~Nov 2, 1995~No~DISCN~ACTAVIS MID ATLANTIC LLC
PROPRANOLOL HYDROCHLORIDE~SOLUTION;ORAL~HEMANGEOL~PIERRE FABRE DERMA~4.28MG/ML~N
~205410~001~~Mar 14, 2014~Yes~RX~PIERRE FABRE DERMATOLOGIE
SODIUM IODIDE I-131~SOLUTION;ORAL~HICON~JUBILANT DRAXIMAGE~1-250mCi/0.25ML~N~021
305~002~~Jan 24, 2003~No~DISCN~JUBILANT DRAXIMAGE INC
SODIUM IODIDE I-131~SOLUTION;ORAL~HICON~JUBILANT DRAXIMAGE~1-500mCi/0.5ML~N~0213
05~003~~Jan 24, 2003~No~DISCN~JUBILANT DRAXIMAGE INC
SODIUM IODIDE I-131~SOLUTION;ORAL~HICON~JUBILANT DRAXIMAGE~1-1000mCi/ML~N~021305
~005~~Apr 4, 2006~No~DISCN~JUBILANT DRAXIMAGE INC
SODIUM IODIDE I-131~SOLUTION;ORAL~HICON~JUBILANT DRAXIMAGE~250-1000mCi~N~021305~
007~~Dec 5, 2011~Yes~RX~JUBILANT DRAXIMAGE INC
ERGOLOID MESYLATES~SOLUTION;ORAL~HYDERGINE~NOVARTIS~1MG/ML~N~018418~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
HYDROCHLOROTHIAZIDE~SOLUTION;ORAL~HYDROCHLOROTHIAZIDE~MORTON GROVE~50MG/5ML~A~08
9661~001~~Jun 20, 1988~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~SOLUTION;ORAL~HYDROCHLOROTHIAZIDE~ROXANE~50MG/5ML~A~088587~0
01~~Jul 2, 1984~No~DISCN~ROXANE LABORATORIES INC
HYDROCHLOROTHIAZIDE~SOLUTION;ORAL~HYDROCHLOROTHIAZIDE INTENSOL~ROXANE~100MG/ML~A
~088588~001~~Jul 2, 1984~No~DISCN~ROXANE LABORATORIES INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~SOLUTION;ORAL~HYDROCODONE BITARTRATE AND A
CETAMINOPHEN~MALLINCKRODT~500MG/15ML;7.5MG/15ML~A~040418~001~~Jun 27, 2001~No~DI
SCN~MALLINCKRODT INC
CETAMINOPHEN~MALLINCKRODT INC~500MG/15ML;10MG/15ML~A~040508~001~~Aug 29, 2003~No
~DISCN~MALLINCKRODT INC
CETAMINOPHEN~MIKART~300MG/15ML;10MG/15ML~A~040881~001~~Feb 25, 2010~Yes~RX~MIKAR
T INC
CETAMINOPHEN~MIKART~325MG/15ML;7.5MG/15ML~A~040482~001~AA~Sep 25, 2003~Yes~RX~MI
KART INC
CETAMINOPHEN~MIKART~500MG/15ML;5MG/15ML~A~081226~001~~Oct 27, 1992~No~DISCN~MIKA
RT INC
CETAMINOPHEN~MIKART~500MG/15ML;5MG/15ML~A~089557~001~~Apr 29, 1992~No~DISCN~MIKA
RT INC
CETAMINOPHEN~MIKART~500MG/15ML;7.5MG/15ML~A~081051~001~~Aug 28, 1992~No~DISCN~MI
KART INC
CETAMINOPHEN~NESHER PHARMS~500MG/15ML;7.5MG/15ML~A~040366~001~~Jan 23, 2002~No~D
ISCN~NESHER PHARMACEUTICALS USA LLC
CETAMINOPHEN~PHARM ASSOC~325MG/15ML;7.5MG/15ML~A~040838~001~AA~May 10, 2013~No~R
X~PHARMACEUTICAL ASSOCIATES INC
CETAMINOPHEN~PHARM ASSOC~325MG/15ML;10MG/15ML~A~040834~001~~Apr 18, 2008~Yes~RX~
PHARMACEUTICAL ASSOC INC
CETAMINOPHEN~PHARM ASSOC~500MG/15ML;7.5MG/15ML~A~040182~001~~Mar 13, 1998~No~DIS
CN~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
CETAMINOPHEN~VINTAGE PHARMS~325MG/15ML;7.5MG/15ML~A~040894~001~AA~Jul 19, 2011~N
o~RX~VINTAGE PHARMACEUTICALS
CETAMINOPHEN~VINTAGE PHARMS~500MG/15ML;7.5MG/15ML~A~040520~001~~Oct 30, 2003~No~
DISCN~VINTAGE PHARMACEUTICALS INC
CETAMINOPHEN~VISTAPHARM~325MG/15ML;7.5MG/15ML~A~200343~001~AA~Jan 25, 2012~No~RX
~VISTAPHARM INC
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE~SOLUTION;ORAL~HYDROCODONE BITAR
TRATE AND CHLORPHENIRAMINE MALEATE~TRIS PHARMA INC~4MG/5ML;5MG/5ML~A~206438~001~
AA~Jan 27, 2015~No~RX~TRIS PHARMA INC
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE~SOLUTION;ORAL~HYDROCODONE
BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE~PADDOCK LLC~5MG/5ML;60MG/5ML~A~2046
58~001~AA~Apr 29, 2014~No~RX~PADDOCK LABORATORIES LLC
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE~SOLUTION;ORAL~HYDROCODONE
BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE~TRIS PHARMA INC~5MG/5ML;60MG/5ML~A~
203839~001~AA~Oct 28, 2014~No~RX~TRIS PHARMA INC
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE~
SOLUTION;ORAL~HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRI
NE HYDROCHLORIDE~TRIS PHARMA INC~4MG/5ML;5MG/5ML;60MG/5ML~A~203838~001~AA~Nov 26
, 2014~No~RX~TRIS PHARMA INC
SOLUTION;ORAL~HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRI
NE HYDROCHLORIDE ~PADDOCK LLC~4MG/5ML;5MG/5ML;60MG/5ML~A~204627~001~AA~Apr 29, 2
HYDROMORPHONE HYDROCHLORIDE~SOLUTION;ORAL~HYDROMORPHONE HYDROCHLORIDE~ROXANE~5MG
/5ML~A~074653~001~AA~Jul 29, 1998~No~RX~ROXANE LABORATORIES INC
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~IMODIUM~JANSSEN PHARMS~1MG/5ML~N~019037~0
01~~Jul 31, 1984~No~DISCN~JANSSEN PHARMACEUTICALS INC
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~IMODIUM A-D~MCNEIL CONS~1MG/5ML~N~019487~
001~~Mar 1, 1988~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
SODIUM IODIDE I-131~SOLUTION;ORAL~IODOTOPE~BRACCO~7-106mCi/BOT~N~010929~002~~App

ISOSORBIDE~SOLUTION;ORAL~ISMOTIC~ALCON~100GM/220ML~N~017063~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
LOPINAVIR; RITONAVIR~SOLUTION;ORAL~KALETRA~ABBVIE~80MG/ML;20MG/ML~N~021251~001~~
Sep 15, 2000~Yes~RX~ABBVIE INC
LEVETIRACETAM~SOLUTION;ORAL~KEPPRA~UCB INC~100MG/ML~N~021505~001~AA~Jul 15, 2003
~Yes~RX~UCB INC
GRANISETRON HYDROCHLORIDE~SOLUTION;ORAL~KYTRIL~ROCHE~EQ 2MG BASE/10ML~N~021238~0
01~~Jun 27, 2001~No~DISCN~HOFFMANN LA ROCHE INC
LACTULOSE~SOLUTION;ORAL~LACTULOSE~ANI PHARMS~10GM/15ML~A~078430~001~AA~Nov 28, 2
LACTULOSE~SOLUTION;ORAL~LACTULOSE~APOTEX INC~10GM/15ML~A~075911~001~~Feb 21, 200
LACTULOSE~SOLUTION;ORAL~LACTULOSE~FRESENIUS KABI~10GM/15ML~A~090503~001~AA~Jan 2
5, 2012~No~RX~FRESENIUS KABI AUSTRIA GMBH
LACTULOSE~SOLUTION;ORAL~LACTULOSE~HI TECH PHARMA~10GM/15ML~A~074076~001~AA~Jul 3
, 1995~No~RX~HI TECH PHARMACAL CO INC
LACTULOSE~SOLUTION;ORAL~LACTULOSE~MORTON GROVE~10GM/15ML~A~071841~001~~Sep 22, 1
988~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
LACTULOSE~SOLUTION;ORAL~LACTULOSE~MORTON GROVE~10GM/15ML~A~074602~001~AA~Nov 14,
1996~No~RX~MORTON GROVE PHARMACEUTICALS INC
LACTULOSE~SOLUTION;ORAL~LACTULOSE~PACO~10GM/15ML~A~073160~001~~Aug 25, 1992~No~D
ISCN~PACO PHARMACEUTICAL SERVICES INC
LACTULOSE~SOLUTION;ORAL~LACTULOSE~PHARM ASSOC~10GM/15ML~A~074623~001~AA~Jul 30,
1996~No~RX~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
LACTULOSE~SOLUTION;ORAL~LACTULOSE~ROXANE~10GM/15ML~A~073591~001~AA~May 29, 1992~
LACTULOSE~SOLUTION;ORAL~LACTULOSE~VINTAGE PHARMS~10GM/15ML~A~075993~001~AA~Jul 2
6, 2001~No~RX~VINTAGE PHARMACEUTICALS INC
LACTULOSE~SOLUTION;ORAL~LACTULOSE~VISTAPHARM~10GM/15ML~A~074138~001~AA~Sep 30, 1
992~No~RX~VISTAPHARM INC
LAMIVUDINE~SOLUTION;ORAL~LAMIVUDINE~SILARX PHARMS INC~10MG/ML~A~203564~001~AA~Oc
t 31, 2014~No~RX~SILARX PHARMACEUTICALS INC
FUROSEMIDE~SOLUTION;ORAL~LASIX~SANOFI AVENTIS US~10MG/ML~N~017688~001~~Approved
LACTULOSE~SOLUTION;ORAL~LAXILOSE~NOSTRUM LABS~10GM/15ML~A~073686~001~~May 28, 19
93~No~DISCN~NOSTRUM LABORATORIES INC
LEVOFLOXACIN~SOLUTION;ORAL~LEVAQUIN~JANSSEN PHARMS~250MG/10ML~N~021721~001~AA~Oc
t 21, 2004~Yes~RX~JANSSEN PHARMACEUTICALS INC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~ACTAVIS MID ATLANTIC~100MG/ML~A~078976
~001~AA~Jan 15, 2009~No~RX~ACTAVIS MID ATLANTIC LLC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~AMNEAL PHARMS~100MG/ML~A~090992~001~AA
~Oct 27, 2009~No~RX~AMNEAL PHARMACEUTICALS
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~APOTEX INC~100MG/ML~A~090187~001~~Aug
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~AUROBINDO PHARM~100MG/ML~A~079063~001~
AA~Jan 15, 2009~No~RX~AUROBINDO PHARMA USA INC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~BRECKENRIDGE PHARM~100MG/ML~A~079120~0
01~AA~Jan 16, 2009~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~HETERO LABS LTD III~100MG/ML~A~203052~
001~AA~Feb 28, 2013~No~RX~HETERO LABS LTD UNIT III
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~HI-TECH PHARMACAL~100MG/ML~A~090601~00
1~AA~Feb 28, 2012~No~RX~HI-TECH PHARMACAL CO INC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~LUPIN LTD~100MG/ML~A~090893~001~AA~Oct
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~ORIT LABS LLC~100MG/ML~A~203067~001~AA
~May 9, 2013~No~RX~ORIT LABORATORIES LLC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~ROXANE~100MG/ML~A~078582~001~AA~Jan 15
, 2009~No~RX~ROXANE LABORATORIES INC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~SILARX~100MG/ML~A~090263~001~AA~Apr 3,
2009~No~RX~SILARX PHARMACEUTICALS INC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~TARO~100MG/ML~A~078774~001~AA~Feb 10,
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~TOLMAR~100MG/ML~A~079107~001~AA~Jan 15
, 2009~No~RX~TOLMAR INC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~TRIS PHARMA INC~100MG/ML~A~090461~001~
AA~Sep 30, 2010~No~RX~TRIS PHARMA INC
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~VINTAGE PHARMS~100MG/ML~A~090079~001~A
A~Apr 11, 2012~No~RX~VINTAGE PHARMACEUTICALS
LEVETIRACETAM~SOLUTION;ORAL~LEVETIRACETAM~WOCKHARDT~100MG/ML~A~090028~001~AA~Mar
3, 2010~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
LEVOCARNITINE~SOLUTION;ORAL~LEVOCARNITINE~HI TECH PHARMA~1GM/10ML~A~077399~001~A
A~Oct 25, 2007~No~RX~HI TECH PHARMACAL CO INC
LEVOCARNITINE~SOLUTION;ORAL~LEVOCARNITINE~LYNE~1GM/10ML~A~076851~001~AA~Aug 10,
LEVOCETIRIZINE DIHYDROCHLORIDE~SOLUTION;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~APOT
EX INC~2.5MG/5ML~A~202915~001~AA~Aug 21, 2014~No~RX~APOTEX INC
LEVOCETIRIZINE DIHYDROCHLORIDE~SOLUTION;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~L PE
RRIGO CO~2.5MG/5ML~A~091263~001~AA~Nov 7, 2011~No~RX~L PERRIGO CO
LEVOCETIRIZINE DIHYDROCHLORIDE~SOLUTION;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~TARO
PHARM INDS~2.5MG/5ML~A~202673~001~AA~Jul 26, 2013~No~RX~TARO PHARMACEUTICAL IND
USTRIES LTD
LEVOFLOXACIN~SOLUTION;ORAL~LEVOFLOXACIN~HI TECH PHARMA~250MG/10ML~A~091678~001~A
A~Jun 20, 2011~No~RX~HI TECH PHARMACAL CO INC
ESCITALOPRAM OXALATE~SOLUTION;ORAL~LEXAPRO~FOREST LABS~EQ 5MG BASE/5ML~N~021365~
001~AA~Nov 27, 2002~Yes~RX~FOREST LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~SOLUTION;ORAL~LIDOCAINE HYDROCHLORIDE~HI TECH PHARMA~2%~
A~040014~001~AT~Jul 10, 1995~No~RX~HI TECH PHARMACAL CO INC
LIDOCAINE HYDROCHLORIDE~SOLUTION;ORAL~LIDOCAINE HYDROCHLORIDE~WOCKHARDT~2%~A~087
872~001~AT~Nov 18, 1982~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
LIDOCAINE HYDROCHLORIDE~SOLUTION;ORAL~LIDOCAINE HYDROCHLORIDE VISCOUS~ACTAVIS MI
D ATLANTIC~2%~A~086578~001~~Approved Prior to Jan 1, 1982~No~DISCN~ACTAVIS MID A
TLANTIC LLC
LIDOCAINE HYDROCHLORIDE~SOLUTION;ORAL~LIDOCAINE HYDROCHLORIDE VISCOUS~INTL MEDIC
ATION~2%~A~086389~001~~Feb 2, 1982~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
LIDOCAINE HYDROCHLORIDE~SOLUTION;ORAL~LIDOCAINE HYDROCHLORIDE VISCOUS~VINTAGE~2%
~A~040708~001~AT~Feb 27, 2007~No~RX~VINTAGE PHARMACEUTICALS LLC
LIDOCAINE HYDROCHLORIDE~SOLUTION;ORAL~LIDOCAINE VISCOUS~ROXANE~2%~A~088802~001~A
T~Apr 26, 1985~No~RX~ROXANE LABORATORIES INC
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~SOLUTION;ORAL~LOMANATE~ALPHARMA US
PHARMS~0.025MG/5ML;2.5MG/5ML~A~085746~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~ALPHARMA US PHARMACEUTICALS DIVISION
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~SOLUTION;ORAL~LOMOTIL~GD SEARLE LL
C~0.025MG/5ML;2.5MG/5ML~N~012699~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD
SEARLE LLC
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~LOPERAMIDE HYDROCHLORIDE~ALPHARMA US PHAR
MS~1MG/5ML~A~073187~001~~Sep 15, 1992~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVIS
ION
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~LOPERAMIDE HYDROCHLORIDE~DURAMED PHARMS B
ARR~1MG/5ML~A~074991~001~~Dec 29, 1997~No~DISCN~DURAMED PHARMACEUTICALS INC SUB
BARR LABORATORIES INC
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~LOPERAMIDE HYDROCHLORIDE~HI TECH PHARMA~1
MG/5ML~A~074352~001~~Nov 17, 1995~No~OTC~HI TECH PHARMACAL CO INC
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~LOPERAMIDE HYDROCHLORIDE~PERRIGO~1MG/5ML~
A~073243~001~~Jan 21, 1992~No~OTC~L PERRIGO CO
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~LOPERAMIDE HYDROCHLORIDE~ROXANE~1MG/5ML~A
~073079~001~~Apr 30, 1992~No~OTC~ROXANE LABORATORIES INC
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~LOPERAMIDE HYDROCHLORIDE~TEVA~1MG/5ML~A~0
73478~001~~Jun 23, 1995~No~DISCN~TEVA PHARMACEUTICALS USA INC
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~LOPERAMIDE HYDROCHLORIDE~WATSON LABS~1MG/

5ML~A~073062~001~~May 28, 1993~No~DISCN~WATSON LABORATORIES INC
LOPERAMIDE HYDROCHLORIDE~SOLUTION;ORAL~LOPERAMIDE HYDROCHLORIDE~WOCKHARDT~1MG/5M
L~A~074730~001~~Aug 28, 1997~No~OTC~WOCKHARDT EU OPERATIONS (SWISS) AG
LORAZEPAM~SOLUTION;ORAL~LORAZEPAM~ROXANE~0.5MG/5ML~A~074648~001~~Mar 18, 1997~No
~DISCN~ROXANE LABORATORIES INC
PREGABALIN~SOLUTION;ORAL~LYRICA~PF PRISM CV~20MG/ML~N~022488~001~~Jan 4, 2010~Ye
s~RX~PF PRISM CV
METHADONE HYDROCHLORIDE~SOLUTION;ORAL~METHADONE HYDROCHLORIDE~ROXANE~5MG/5ML~A~0
87393~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~ROXANE LABORATORIES INC
METHADONE HYDROCHLORIDE~SOLUTION;ORAL~METHADONE HYDROCHLORIDE~ROXANE~10MG/5ML~A~
087997~001~AA~Aug 30, 1982~Yes~RX~ROXANE LABORATORIES INC
METHADONE HYDROCHLORIDE~SOLUTION;ORAL~METHADONE HYDROCHLORIDE~VISTAPHARM~5MG/5ML
~A~090707~001~AA~Jun 30, 2010~No~RX~VISTAPHARM INC
METHADONE HYDROCHLORIDE~SOLUTION;ORAL~METHADONE HYDROCHLORIDE~VISTAPHARM~10MG/5M
L~A~090707~002~AA~Jun 30, 2010~No~RX~VISTAPHARM INC
METHYLPHENIDATE HYDROCHLORIDE~SOLUTION;ORAL~METHYLIN~MALLINCKRODT~5MG/5ML~N~0214
19~001~AA~Dec 19, 2002~Yes~RX~MALLINCKRODT INC
METHYLPHENIDATE HYDROCHLORIDE~SOLUTION;ORAL~METHYLIN~MALLINCKRODT~10MG/5ML~N~021
419~002~AA~Dec 19, 2002~Yes~RX~MALLINCKRODT INC
METHYLPHENIDATE HYDROCHLORIDE~SOLUTION;ORAL~METHYLPHENIDATE HYDROCHLORIDE~SUN PH
ARM INDS INC~5MG/5ML~A~201466~001~AA~Nov 12, 2013~No~RX~SUN PHARMACEUTICAL INDUS
TRIES INC
METHYLPHENIDATE HYDROCHLORIDE~SOLUTION;ORAL~METHYLPHENIDATE HYDROCHLORIDE~SUN PH
ARM INDS INC~10MG/5ML~A~201466~002~AA~Nov 12, 2013~No~RX~SUN PHARMACEUTICAL INDU
STRIES INC
METHYLPHENIDATE HYDROCHLORIDE~SOLUTION;ORAL~METHYLPHENIDATE HYDROCHLORIDE~TRIS P
HARMA INC~5MG/5ML~A~091601~001~AA~Jul 23, 2010~No~RX~TRIS PHARMA INC
METHYLPHENIDATE HYDROCHLORIDE~SOLUTION;ORAL~METHYLPHENIDATE HYDROCHLORIDE~TRIS P
HARMA INC~10MG/5ML~A~091601~002~AA~Jul 23, 2010~No~RX~TRIS PHARMA INC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~ACTAVIS
MID ATLANTIC~EQ 5MG BASE/5ML~A~071340~001~~Aug 18, 1988~No~DISCN~ACTAVIS MID ATL
ANTIC LLC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~ANI PHAR
MS~EQ 5MG BASE/5ML~A~071402~001~AA~Jun 25, 1993~No~RX~ANI PHARMACEUTICALS INC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~MORTON G
ROVE~EQ 5MG BASE/5ML~A~070949~001~~Mar 6, 1987~No~DISCN~MORTON GROVE PHARMACEUTI
CALS INC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~PACO~EQ
5MG BASE/5ML~A~071665~001~~Dec 5, 1988~No~DISCN~PACO RESEARCH CORP
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~PHARM AS
SOC~EQ 5MG BASE/5ML~A~072744~001~AA~May 28, 1991~No~RX~PHARMACEUTICAL ASSOC INC
DIV BEACH PRODUCTS
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~ROXANE~E
Q 5MG BASE/5ML~A~072038~001~~Dec 5, 1988~No~DISCN~ROXANE LABORATORIES INC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~SILARX~E
Q 5MG BASE/5ML~A~073680~001~AA~Oct 27, 1992~No~RX~SILARX PHARMACEUTICALS INC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~TEVA~EQ
5MG BASE/5ML~A~070819~001~~Jul 10, 1987~No~DISCN~TEVA PHARMACEUTICALS USA INC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~TEVA~EQ
5MG BASE/5ML~A~071315~001~~Jun 30, 1993~No~DISCN~TEVA PHARMACEUTICALS USA INC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~VISTAPHA
RM~EQ 5MG BASE/5ML~A~075051~001~AA~Jan 26, 2001~No~RX~VISTAPHARM INC
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~WOCKHARD
T~EQ 5MG BASE/5ML~A~074703~001~AA~Oct 31, 1997~Yes~RX~WOCKHARDT EU OPERATIONS (S
WISS) AG
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~LANNETT HOLDINGS INC~100MG/5ML~N
~201517~001~~Jun 23, 2011~No~RX~LANNETT HOLDINGS INC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~MALLINCKRODT INC~100MG/5ML~A~202
348~001~AA~Jul 15, 2011~No~RX~MALLINCKRODT INC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~PADDOCK LLC~100MG/5ML~A~201574~0

01~AA~Aug 6, 2012~No~RX~PADDOCK LABORATORIES LLC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~ROXANE~10MG/5ML~N~022195~001~AA~
Mar 17, 2008~No~RX~ROXANE LABORATORIES INC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~ROXANE~20MG/5ML~N~022195~002~AA~
Mar 17, 2008~No~RX~ROXANE LABORATORIES INC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~ROXANE~100MG/5ML~N~022195~003~AA
~Jan 25, 2010~Yes~RX~ROXANE LABORATORIES INC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~SUN PHARM INDS INC~10MG/5ML~A~20
1011~001~AA~Feb 5, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~SUN PHARM INDS INC~20MG/5ML~A~20
1011~002~AA~Feb 5, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~VISTAPHARM~10MG/5ML~A~201947~001
~AA~Jan 5, 2012~No~RX~VISTAPHARM INC
MORPHINE SULFATE~SOLUTION;ORAL~MORPHINE SULFATE~VISTAPHARM~20MG/5ML~A~201947~002
~AA~Jan 5, 2012~No~RX~VISTAPHARM INC
NEOMYCIN SULFATE~SOLUTION;ORAL~MYCIFRADIN~PHARMACIA AND UPJOHN~EQ 87.5MG BASE/5M
L~N~050285~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
MEMANTINE HYDROCHLORIDE~SOLUTION;ORAL~NAMENDA~FOREST LABS~2MG/ML~N~021627~001~~A
pr 18, 2005~Yes~RX~FOREST LABORATORIES INC
NEOMYCIN SULFATE~SOLUTION;ORAL~NEO-FRADIN~X GEN PHARMS~EQ 87.5MG BASE/5ML~A~0650
10~001~~May 23, 2002~Yes~RX~X GEN PHARMACEUTICALS INC
CYCLOSPORINE~SOLUTION;ORAL~NEORAL~NOVARTIS~100MG/ML~N~050716~001~AB1~Jul 14, 199
GABAPENTIN~SOLUTION;ORAL~NEURONTIN~PARKE DAVIS~250MG/5ML~N~021129~001~AA~Mar 2,
2000~Yes~RX~PARKE DAVIS DIV WARNER LAMBERT CO
NIZATIDINE~SOLUTION;ORAL~NIZATIDINE~AMNEAL PHARMS~15MG/ML~A~090576~001~AA~Nov 18
, 2009~No~RX~AMNEAL PHARMACEUTICALS
NORTRIPTYLINE HYDROCHLORIDE~SOLUTION;ORAL~NORTRIPTYLINE HYDROCHLORIDE~PHARM ASSO
C~EQ 10MG BASE/5ML~A~075606~001~AA~Aug 28, 2000~Yes~RX~PHARMACEUTICAL ASSOC INC
NORTRIPTYLINE HYDROCHLORIDE~SOLUTION;ORAL~NORTRIPTYLINE HYDROCHLORIDE~TARO~EQ 10
MG BASE/5ML~A~077965~001~AA~Jun 20, 2006~No~RX~TARO PHARMACEUTICAL INDUSTRIES LT
D
RITONAVIR~SOLUTION;ORAL~NORVIR~ABBVIE~80MG/ML~N~020659~001~~Mar 1, 1996~Yes~RX~A
BBVIE INC
TAPENTADOL HYDROCHLORIDE~SOLUTION;ORAL~NUCYNTA~JANSSEN PHARMS~EQ 20MG BASE/ML~N~
203794~001~~Oct 15, 2012~Yes~RX~JANSSEN PHARMACEUTICALS INC
NIMODIPINE~SOLUTION;ORAL~NYMALIZE~ARBOR PHARMS LLC~60MG/20ML~N~203340~001~~May 1
0, 2013~Yes~RX~ARBOR PHARMACEUTICALS LLC
GUAIFENESIN; HYDROCODONE BITARTRATE~SOLUTION;ORAL~OBREDON~SOVEREIGN PHARMS~200MG
/5ML;2.5MG/5ML~N~205474~001~~Nov 14, 2014~Yes~RX~SOVEREIGN PHARMACEUTICALS LLC
E; SODIUM SULFATE~SOLUTION;ORAL~OCL~HOSPIRA~6GM/100ML;75MG/100ML;168MG/100ML;146
MG/100ML;1.29GM/100ML~N~019284~001~~Apr 30, 1986~No~DISCN~HOSPIRA INC
ONDANSETRON HYDROCHLORIDE~SOLUTION;ORAL~ONDANSETRON HYDROCHLORIDE~AMNEAL PHARMS~
EQ 4MG BASE/5ML~A~091483~001~AA~Jan 31, 2011~No~RX~AMNEAL PHARMACEUTICALS
ONDANSETRON HYDROCHLORIDE~SOLUTION;ORAL~ONDANSETRON HYDROCHLORIDE~APOTEX~EQ 4MG
BASE/5ML~A~078127~001~AA~Jun 25, 2007~No~RX~APOTEX INC
ONDANSETRON HYDROCHLORIDE~SOLUTION;ORAL~ONDANSETRON HYDROCHLORIDE~AUROBINDO PHAR
MA~EQ 4MG BASE/5ML~A~078776~001~AA~Nov 28, 2007~No~RX~AUROBINDO PHARMA LTD
ONDANSETRON HYDROCHLORIDE~SOLUTION;ORAL~ONDANSETRON HYDROCHLORIDE~ROXANE~EQ 4MG
BASE/5ML~A~076960~001~AA~Dec 26, 2006~No~RX~ROXANE LABORATORIES INC
ONDANSETRON HYDROCHLORIDE~SOLUTION;ORAL~ONDANSETRON HYDROCHLORIDE~SILARX~EQ 4MG
BASE/5ML~A~091342~001~AA~Jan 27, 2011~No~RX~SILARX PHARMACEUTICALS INC
ONDANSETRON HYDROCHLORIDE~SOLUTION;ORAL~ONDANSETRON HYDROCHLORIDE~TARO~EQ 4MG BA
SE/5ML~A~077009~001~AA~Nov 30, 2007~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~ORAPRED~CONCORDIA PHARMS INC~EQ 15MG
BASE/5ML~A~075117~001~AA~Dec 14, 2000~Yes~RX~CONCORDIA PHARMACEUTICALS INC
OXTRIPHYLLINE~SOLUTION;ORAL~OXTRIPHYLLINE~MORTON GROVE~100MG/5ML~A~088243~001~~D
ec 5, 1983~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE AND ACETAMINOPHEN

~MALLINCKRODT INC~325MG/5ML;5MG/5ML~A~040680~001~~Sep 29, 2006~No~DISCN~MALLINCK
RODT INC
OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE~COASTAL PHARMS~100
MG/5ML~A~204092~001~AA~Jun 5, 2014~No~RX~COASTAL PHARMACEUTICALS
OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE~LANNETT HOLDINGS I
NC~100MG/5ML~A~204085~001~AA~Sep 9, 2014~No~RX~LANNETT HOLDINGS INC
OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE~LEHIGH VALLEY~5MG/
5ML~N~200535~002~AA~Aug 22, 2013~No~RX~LEHIGH VALLEY TECHNOLOGIES INC
OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE~LEHIGH VALLEY~100M
G/5ML~N~200535~001~AA~Oct 20, 2010~Yes~RX~LEHIGH VALLEY TECHNOLOGIES INC
OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE~ROXANE~5MG/5ML~A~2
04037~001~AA~Jul 15, 2013~No~RX~ROXANE LABORATORIES INC
OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE~ROXANE~100MG/5ML~A
~203208~001~AA~Jul 12, 2013~No~RX~ROXANE LABORATORIES INC
OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE~VISTAPHARM~5MG/5ML
~N~201194~001~AA~Jan 12, 2012~Yes~RX~VISTAPHARM INC
OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE~VISTAPHARM~100MG/5
ML~A~202537~001~AA~Jul 30, 2012~No~RX~VISTAPHARM INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~OXYCODONE HYDROCHLORIDE AND
ACETAMINOPHEN~VINTAGE PHARMS~325MG/5ML;5MG/5ML~A~203573~001~AA~Dec 18, 2014~No~
RX~VINTAGE PHARMACEUTICALS
NORTRIPTYLINE HYDROCHLORIDE~SOLUTION;ORAL~PAMELOR~MALLINCKRODT INC~EQ 10MG BASE/
5ML~N~018012~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT INC
PARAMETHADIONE~SOLUTION;ORAL~PARADIONE~ABBVIE~300MG/ML~N~006800~002~~Approved Pr
ior to Jan 1, 1982~No~DISCN~ABBVIE INC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PEDIAPRED~SETON PHARM~EQ 5MG BASE/5M
L~N~019157~001~AA~May 28, 1986~Yes~RX~SETON PHARMACEUTICAL LLC
CALCIUM ACETATE~SOLUTION;ORAL~PHOSLYRA~FRESENIUS MEDCL~EQ 169MG CALCIUM/5ML~N~02
2581~001~~Apr 18, 2011~Yes~RX~FRESENIUS MEDICAL CARE NORTH AMERICA
POTASSIUM CHLORIDE~SOLUTION;ORAL~POTASSIUM CHLORIDE~PHARMA-MED INC~20MEQ/15ML~N~
206814~001~~Dec 22, 2014~No~RX~PHARMA-MED INC
POTASSIUM CHLORIDE~SOLUTION;ORAL~POTASSIUM CHLORIDE~PHARMA-MED INC~40MEQ/15ML~N~
206814~002~~Dec 22, 2014~Yes~RX~PHARMA-MED INC
POTASSIUM IODIDE~SOLUTION;ORAL~POTASSIUM IODIDE~ROXANE~1GM/ML~N~018551~001~~Feb
19, 1982~No~DISCN~ROXANE LABORATORIES INC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~AMNEAL
PHARMS~EQ 15MG BASE/5ML~A~078345~001~AA~Mar 10, 2009~No~RX~AMNEAL PHARMACEUTICA
LS
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~HI TEC
H PHARMA~EQ 5MG BASE/5ML~A~075183~001~AA~Mar 26, 2003~No~RX~HI TECH PHARMACAL CO
INC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~MEDICI
S PHARMS~EQ 15MG BASE/5ML~A~075250~001~~Jul 12, 2002~No~DISCN~MEDICIS PHARMACEUT
ICALS A DIV OF VALEANT PHARMACEUTICALS NORTH AMERICA LLC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~MISSIO
N PHARMA~EQ 25MG BASE/5ML~A~091396~001~~Sep 13, 2010~Yes~RX~MISSION PHARMACAL CO
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~NESHER
PHARMS~EQ 5MG BASE/5ML~A~076982~001~~May 24, 2005~No~DISCN~NESHER PHARMACEUTICA
LS USA LLC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~NESHER
PHARMS~EQ 15MG BASE/5ML~A~076988~001~~May 24, 2005~No~DISCN~NESHER PHARMACEUTIC
ALS USA LLC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~PADDOC
K LLC~EQ 5MG BASE/5ML~A~075988~001~AA~May 25, 2004~No~RX~PADDOCK LABORATORIES LL
C
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~PHARM
ASSOC~EQ 5MG BASE/5ML~A~076123~001~~Dec 23, 2002~No~DISCN~PHARMACEUTICAL ASSOC I
NC
ASSOC~EQ 10MG BASE/5ML~A~078465~001~~Mar 7, 2008~Yes~RX~PHARMACEUTICAL ASSOC INC

ASSOC~EQ 15MG BASE/5ML~A~076913~001~AA~Apr 25, 2005~No~RX~PHARMACEUTICAL ASSOC I
NC
ASSOC~EQ 20MG BASE/5ML~A~078988~001~~Jun 9, 2008~Yes~RX~PHARMACEUTICAL ASSOC INC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~VINTAG
E~EQ 15MG BASE/5ML~A~079010~001~AA~May 26, 2009~No~RX~VINTAGE PHARMACEUTICALS LL
C
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~VINTAG
E PHARMS~EQ 5MG BASE/5ML~A~078416~001~~Oct 31, 2007~No~DISCN~VINTAGE PHARMACEUTI
CALS
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~WE PHA
RMS~EQ 5MG BASE/5ML~A~075181~001~~Dec 23, 2002~No~DISCN~WE PHARMACEUTICALS INC
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~WOCKHA
RDT~EQ 5MG BASE/5ML~A~075099~001~AA~Jun 28, 2002~No~RX~WOCKHARDT EU OPERATIONS (
SWISS) AG
PREDNISOLONE SODIUM PHOSPHATE~SOLUTION;ORAL~PREDNISOLONE SODIUM PHOSPHATE~WOCKHA
RDT~EQ 15MG BASE/5ML~A~076895~001~AA~Oct 4, 2004~No~RX~WOCKHARDT EU OPERATIONS (
SWISS) AG
PREDNISONE~SOLUTION;ORAL~PREDNISONE~ROXANE~5MG/5ML~A~088703~001~~Nov 8, 1984~Yes
~RX~ROXANE LABORATORIES INC
PREDNISONE~SOLUTION;ORAL~PREDNISONE~WOCKHARDT~5MG/5ML~A~089726~001~~Aug 2, 1988~
No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
PREDNISONE~SOLUTION;ORAL~PREDNISONE INTENSOL~ROXANE~5MG/ML~A~088810~001~~Feb 20,
TRIMETHOPRIM HYDROCHLORIDE~SOLUTION;ORAL~PRIMSOL~FSC~EQ 25MG BASE/5ML~A~074374~0
01~~Jun 23, 1995~No~DISCN~FSC LABORATORIES INC
TRIMETHOPRIM HYDROCHLORIDE~SOLUTION;ORAL~PRIMSOL~FSC~EQ 50MG BASE/5ML~N~074973~0
01~~Jan 24, 2000~Yes~RX~FSC LABORATORIES INC
PROPRANOLOL HYDROCHLORIDE~SOLUTION;ORAL~PROPRANOLOL HYDROCHLORIDE~MORTON GROVE~2
0MG/5ML~A~071984~001~~Mar 3, 1989~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
PROPRANOLOL HYDROCHLORIDE~SOLUTION;ORAL~PROPRANOLOL HYDROCHLORIDE~MORTON GROVE~4
0MG/5ML~A~071985~001~~Mar 3, 1989~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
PROPRANOLOL HYDROCHLORIDE~SOLUTION;ORAL~PROPRANOLOL HYDROCHLORIDE~ROXANE~20MG/5M
L~A~070979~001~~May 15, 1987~Yes~RX~ROXANE LABORATORIES INC
PROPRANOLOL HYDROCHLORIDE~SOLUTION;ORAL~PROPRANOLOL HYDROCHLORIDE~ROXANE~40MG/5M
L~A~070690~001~~May 15, 1987~Yes~RX~ROXANE LABORATORIES INC
FLUOXETINE HYDROCHLORIDE~SOLUTION;ORAL~PROZAC~LILLY~EQ 20MG BASE/5ML~N~020101~00
1~~Apr 24, 1991~No~DISCN~ELI LILLY AND CO
SIROLIMUS~SOLUTION;ORAL~RAPAMUNE~PF PRISM CV~1MG/ML~N~021083~001~~Sep 15, 1999~Y
es~RX~PF PRISM CV
GALANTAMINE HYDROBROMIDE~SOLUTION;ORAL~RAZADYNE~JANSSEN PHARMS~4MG/ML~N~021224~0
01~AA~Jun 22, 2001~Yes~RX~JANSSEN PHARMACEUTICALS INC
RIBAVIRIN~SOLUTION;ORAL~REBETOL~SCHERING~40MG/ML~N~021546~001~~Jul 29, 2003~Yes~
RX~SCHERING CORP
METOCLOPRAMIDE HYDROCHLORIDE~SOLUTION;ORAL~REGLAN~ROBINS AH~EQ 5MG BASE/5ML **Fe
safety or efficacy reasons**~N~018821~001~~Mar 25, 1983~No~DISCN~AH ROBINS CO
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE~SOLUTION;ORAL~REZIRA~CYPRE
SS PHARM~5MG/5ML;60MG/5ML~N~022442~001~AA~Jun 8, 2011~Yes~RX~CYPRESS PHARMACEUTI
CAL INC
METFORMIN HYDROCHLORIDE~SOLUTION;ORAL~RIOMET~RANBAXY~500MG/5ML~N~021591~001~~Sep
11, 2003~Yes~RX~RANBAXY PHARMACEUTICALS INC
RISPERIDONE~SOLUTION;ORAL~RISPERDAL~JANSSEN PHARMS~1MG/ML~N~020588~001~AA~Jun 10
, 1996~Yes~RX~JANSSEN PHARMACEUTICALS INC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~AMNEAL PHARMS~1MG/ML~A~091384~001~AA~May 2
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~ANI PHARMS INC~1MG/ML~A~076440~001~AA~Jan
30, 2009~No~RX~ANI PHARMACEUTICALS INC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~APOTEX INC~1MG/ML~A~077719~001~AA~Jul 29,

2009~No~RX~APOTEX INC RICHMOND HILL
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~AUROBINDO PHARMA~1MG/ML~A~078452~001~AA~Se
p 4, 2009~No~RX~AUROBINDO PHARMA LTD
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~BIO PHARM INC~1MG/ML~A~078909~001~AA~Jul 2
9, 2009~No~RX~BIO PHARM INC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~PRECISION DOSE~1MG/ML~A~076797~001~AA~Jun
28, 2010~No~RX~PRECISION DOSE INC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~ROXANE~1MG/ML~A~076904~001~AA~Jul 29, 2009
~No~RX~ROXANE LABORATORIES INC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~SILARX PHARMS INC~1MG/ML~A~202386~001~AA~J
an 12, 2015~No~RX~SILARX PHARMACEUTICALS INC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~TARO~1MG/ML~A~090347~001~AA~Feb 7, 2011~No
~RX~TARO PHARMACEUTICALS USA INC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~TRIS PHARMA INC~1MG/ML~A~079059~001~AA~Dec
12, 2012~No~RX~TRIS PHARMA INC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~VINTAGE~1MG/ML~A~079158~001~AA~Dec 3, 2010
~No~RX~VINTAGE PHARMACEUTICALS LLC
RISPERIDONE~SOLUTION;ORAL~RISPERIDONE~WOCKHARDT~1MG/ML~A~078744~001~AA~Oct 8, 20
09~No~RX~WOCKHARDT LTD
CALCITRIOL~SOLUTION;ORAL~ROCALTROL~VALIDUS PHARMS~1MCG/ML~N~021068~001~AA~Nov 20
, 1998~Yes~RX~VALIDUS PHARMACEUTICALS LLC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~SOLUTION;ORAL~ROXICET~ROXANE~325MG/5ML;5M
G/5ML~A~089351~001~AA~Dec 3, 1986~Yes~RX~ROXANE LABORATORIES INC
CYCLOSPORINE~SOLUTION;ORAL~SANDIMMUNE~NOVARTIS~100MG/ML~N~050574~001~AB2~Nov 14,
SODIUM IODIDE I-123~SOLUTION;ORAL~SODIUM IODIDE I 123~GE HEALTHCARE~2mCi/ML~N~01
SODIUM IODIDE I-131~SOLUTION;ORAL~SODIUM IODIDE I 131~CIS~50mCi/ML~N~017315~001~
~Approved Prior to Jan 1, 1982~No~DISCN~CIS BIOINDUSTRIES COMPAGNIE
SODIUM IODIDE I-131~SOLUTION;ORAL~SODIUM IODIDE I 131~MALLINCKRODT~3.5-150mCi/VI
AL~N~016515~001~~Approved Prior to Jan 1, 1982~Yes~RX~MALLINCKRODT MEDICAL INC
TAMOXIFEN CITRATE~SOLUTION;ORAL~SOLTAMOX~DARA BIOSCIENCES~EQ 10MG BASE/5ML~N~021
807~001~~Oct 29, 2005~No~RX~DARA BIOSCIENCES INC
AMINOPHYLLINE~SOLUTION;ORAL~SOMOPHYLLIN~FISONS~105MG/5ML~A~086466~001~~Approved
Prior to Jan 1, 1982~No~DISCN~FISONS CORP
AMINOPHYLLINE~SOLUTION;ORAL~SOMOPHYLLIN-DF~FISONS~105MG/5ML~A~087045~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~FISONS CORP
SOTALOL HYDROCHLORIDE~SOLUTION;ORAL~SOTYLIZE~ARBOR PHARMS LLC~5MG/ML (5MG/ML)~N~
205108~001~~Oct 22, 2014~Yes~RX~ARBOR PHARMACEUTICALS LLC
ITRACONAZOLE~SOLUTION;ORAL~SPORANOX~JANSSEN PHARMS~10MG/ML~N~020657~001~~Feb 21,
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFA
TE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE~SOLUTION;ORAL~SUCLEAR~BR
AINTREE LABS~1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0
.74GM,2.86GM,5.6GM~N~203595~001~~Jan 18, 2013~Yes~RX~BRAINTREE LABORATORIES INC
SACROSIDASE~SOLUTION;ORAL~SUCRAID~QOL MEDCL~8,500 IU/ML~N~020772~001~~Apr 9, 199
8~Yes~RX~QOL MEDICAL LLC
MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE~SOLUTION;ORAL~SUP
REP BOWEL PREP KIT~BRAINTREE LABS~1.6GM/BOT;3.13GM/BOT;17.5GM/BOT~N~022372~001~~
Aug 5, 2010~Yes~RX~BRAINTREE LABORATORIES INC
CIMETIDINE HYDROCHLORIDE~SOLUTION;ORAL~TAGAMET~GLAXOSMITHKLINE~EQ 300MG BASE/5ML
TECHNETIUM TC-99M SULFUR COLLOID~SOLUTION;ORAL~TECHNETIUM TC 99M SULFUR COLLOID~
MALLINCKRODT~3mCi/ML~N~017724~001~~Approved Prior to Jan 1, 1982~No~DISCN~MALLIN
CKRODT MEDICAL INC
THEOPHYLLINE~SOLUTION;ORAL~THEOLAIR~3M~80MG/15ML~A~086107~001~~Approved Prior to
Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
THEOPHYLLINE~SOLUTION;ORAL~THEOPHYLLINE~ROXANE~80MG/15ML~A~087449~001~~Sep 15, 1
THEOPHYLLINE~SOLUTION;ORAL~THEOPHYLLINE~SILARX~80MG/15ML~A~091156~001~AA~Apr 13,
2011~Yes~RX~SILARX PHARMACEUTICALS INC
THEOPHYLLINE~SOLUTION;ORAL~THEOPHYLLINE~TRIS PHARMA INC~80MG/15ML~A~091586~001~A
A~Jun 15, 2012~No~RX~TRIS PHARMA INC
POTASSIUM IODIDE~SOLUTION;ORAL~THYROSHIELD~ARCO PHARMS LLC~65MG/ML~A~077218~001~
~Jan 12, 2005~Yes~OTC~ARCO PHARMACEUTICALS LLC
TRICLOFOS SODIUM~SOLUTION;ORAL~TRICLOS~SANOFI AVENTIS US~1.5GM/15ML~N~016830~001
TRIMETHADIONE~SOLUTION;ORAL~TRIDIONE~ABBVIE~200MG/5ML~N~005856~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~ABBVIE INC
ACETAMINOPHEN; CODEINE PHOSPHATE~SOLUTION;ORAL~TYLENOL W/ CODEINE~ORTHO MCNEIL P
HARM~120MG/5ML;12MG/5ML~A~085057~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORT
HO MCNEIL PHARMACEUTICAL INC
TELBIVUDINE~SOLUTION;ORAL~TYZEKA~NOVARTIS~100MG/5ML~N~022154~001~~Apr 28, 2009~N
o~DISCN~NOVARTIS PHARMACEUTICALS CORP
SODIUM BENZOATE; SODIUM PHENYLACETATE~SOLUTION;ORAL~UCEPHAN~B BRAUN~100MG/ML;100
MG/ML~N~019530~001~~Dec 23, 1987~No~DISCN~B BRAUN MEDICAL INC
LACOSAMIDE~SOLUTION;ORAL~VIMPAT~UCB INC~10MG/ML~N~022255~001~~Apr 20, 2010~Yes~R
X~UCB INC
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE~SOLUTION;ORAL~VITUZ~CYPRESS PHA
RM~4MG/5ML;5MG/5ML~N~204307~001~AA~Feb 20, 2013~Yes~RX~CYPRESS PHARMACEUTICAL IN
C
LIDOCAINE HYDROCHLORIDE~SOLUTION;ORAL~XYLOCAINE VISCOUS~FRESENIUS KABI USA~2%~N~
009470~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KABI USA LLC
SODIUM OXYBATE~SOLUTION;ORAL~XYREM~JAZZ PHARMS~500MG/ML~N~021196~001~~Jul 17, 20
02~Yes~RX~JAZZ PHARMACEUTICALS INC
LEVOCETIRIZINE DIHYDROCHLORIDE~SOLUTION;ORAL~XYZAL~UCB INC~2.5MG/5ML~N~022157~00
1~AA~Jan 28, 2008~Yes~RX~UCB INC
ABACAVIR SULFATE~SOLUTION;ORAL~ZIAGEN~VIIV HLTHCARE~EQ 20MG BASE/ML~N~020978~001
~~Dec 17, 1998~Yes~RX~VIIV HEALTHCARE CO
ONDANSETRON HYDROCHLORIDE~SOLUTION;ORAL~ZOFRAN~GLAXOSMITHKLINE~EQ 4MG BASE/5ML~N
~020605~001~AA~Jan 24, 1997~Yes~RX~GLAXOSMITHKLINE
SOLUTION;ORAL~ZUTRIPRO~CYPRESS PHARM~4MG/5ML;5MG/5ML;60MG/5ML~N~022439~001~AA~Ju
n 8, 2011~Yes~RX~CYPRESS PHARMACEUTICAL INC
LACTULOSE~SOLUTION;ORAL, RECTAL~ACILAC~NOSTRUM LABS~10GM/15ML~A~073685~001~~May
28, 1993~No~DISCN~NOSTRUM LABORATORIES INC
LACTULOSE~SOLUTION;ORAL, RECTAL~CEPHULAC~SANOFI AVENTIS US~10GM/15ML~N~017657~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
LACTULOSE~SOLUTION;ORAL, RECTAL~CHOLAC~ALRA~10GM/15ML~A~071331~001~AA~Jul 26, 19
88~No~RX~ALRA LABORATORIES INC
LACTULOSE~SOLUTION;ORAL, RECTAL~ENULOSE~ACTAVIS MID ATLANTIC~10GM/15ML~A~071548~
001~AA~Aug 15, 1988~Yes~RX~ACTAVIS MID ATLANTIC LLC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~SOLUTION;ORAL, RECTAL~GASTROGRAFIN~BRA
CCO~66%;10%~N~011245~003~AA~Approved Prior to Jan 1, 1982~Yes~RX~BRACCO DIAGNOST
ICS INC
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~SOLUTION;ORAL, RECTAL~GASTROVIST~BAYER
HLTHCARE~66%;10%~A~087728~001~~Sep 23, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEU
TICALS INC
LACTULOSE~SOLUTION;ORAL, RECTAL~GENERLAC~MORTON GROVE~10GM/15ML~A~071842~001~~Se
p 27, 1988~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
LACTULOSE~SOLUTION;ORAL, RECTAL~GENERLAC~MORTON GROVE PHARMS~10GM/15ML~A~074603~
001~AA~Oct 31, 1996~No~RX~MORTON GROVE PHARMACEUTICALS INC
LACTULOSE~SOLUTION;ORAL, RECTAL~HEPTALAC~TEVA PHARMS~10GM/15ML~A~073504~001~~May
28, 1993~No~DISCN~TEVA PHARMACEUTICALS USA
DIATRIZOATE SODIUM~SOLUTION;ORAL, RECTAL~HYPAQUE~GE HEALTHCARE~40%~N~011386~003~
~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
LACTULOSE~SOLUTION;ORAL, RECTAL~LACTULOSE~ANI PHARMS~10GM/15ML~A~090426~001~AA~N
ov 21, 2008~No~RX~ANI PHARMACEUTICALS INC
LACTULOSE~SOLUTION;ORAL, RECTAL~LACTULOSE~APOTEX INC~10GM/15ML~A~076645~001~~Jul

LACTULOSE~SOLUTION;ORAL, RECTAL~LACTULOSE~FRESENIUS KABI~10GM/15ML~A~090502~001~
AA~Jan 25, 2012~No~RX~FRESENIUS KABI AUSTRIA GMBH
LACTULOSE~SOLUTION;ORAL, RECTAL~LACTULOSE~HI TECH PHARMA~10GM/15ML~A~074077~001~
AA~Jul 3, 1995~No~RX~HI TECH PHARMACAL CO INC
LACTULOSE~SOLUTION;ORAL, RECTAL~LACTULOSE~PACO~10GM/15ML~A~072029~001~~Aug 25, 1
992~No~DISCN~PACO PHARMACEUTICAL SERVICES INC
LACTULOSE~SOLUTION;ORAL, RECTAL~LACTULOSE~ROXANE~10GM/15ML~A~073590~001~~May 29,
LACTULOSE~SOLUTION;ORAL, RECTAL~LACTULOSE~SOLVAY~10GM/15ML~N~017906~001~~Approve
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM~SOLUTION;ORAL, RECTAL~MD-GASTROVIEW~LI
EBEL-FLARSHEIM~66%;10%~A~087388~001~AA~Approved Prior to Jan 1, 1982~No~RX~LIEBE
L-FLARSHEIM CO LLC
LACTULOSE~SOLUTION;ORAL, RECTAL~PORTALAC~SOLVAY~10GM/15ML~A~072374~001~~Mar 22,
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE~SOLUTI
ON;PERFUSION, CARDIAC~CARDIOPLEGIC IN PLASTIC CONTAINER~BAXTER HLTHCARE~17.6MG/1
00ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML~A~075323~001~AT~Apr 21, 2000~No~RX~
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE~SOLUTI
ON;PERFUSION, CARDIAC~PLEGISOL IN PLASTIC CONTAINER~HOSPIRA~17.6MG/100ML;325.3MG
/100ML;119.3MG/100ML;643MG/100ML~N~018608~001~AT~Feb 26, 1982~Yes~RX~HOSPIRA INC
MIPOMERSEN SODIUM~SOLUTION;SUBCUTANEOUS~KYNAMRO~GENZYME CORP~200MG/ML (200MG/ML)
~N~203568~001~~Jan 29, 2013~Yes~RX~GENZYME CORP
PLERIXAFOR~SOLUTION;SUBCUTANEOUS~MOZOBIL~GENZYME~24MG/1.2ML (20MG/ML)~N~022311~0
01~~Dec 15, 2008~Yes~RX~GENZYME CORP
METHOTREXATE~SOLUTION;SUBCUTANEOUS~OTREXUP~ANTARES PHARMA INC~7.5MG/0.4ML (7.5MG
/0.4ML)~N~204824~005~~Nov 7, 2014~No~RX~ANTARES PHARMA INC
METHOTREXATE~SOLUTION;SUBCUTANEOUS~OTREXUP~ANTARES PHARMA INC~10MG/0.4ML (10MG/0
.4ML)~N~204824~001~~Oct 11, 2013~No~RX~ANTARES PHARMA INC
.4ML)~N~204824~004~~Oct 11, 2013~Yes~RX~ANTARES PHARMA INC
METHOTREXATE~SOLUTION;SUBCUTANEOUS~RASUVO~MEDAC PHARMA INC~7.5MG/0.15ML (7.5MG/0
.15ML)~N~205776~001~~Jul 10, 2014~No~RX~MEDAC PHARMA INC
METHOTREXATE~SOLUTION;SUBCUTANEOUS~RASUVO~MEDAC PHARMA INC~10MG/0.20ML (10MG/0.2
0ML)~N~205776~002~~Jul 10, 2014~No~RX~MEDAC PHARMA INC
METHOTREXATE~SOLUTION;SUBCUTANEOUS~RASUVO~MEDAC PHARMA INC~12.5MG/0.25ML (12.5MG
/0.25ML)~N~205776~003~~Jul 10, 2014~No~RX~MEDAC PHARMA INC
METHOTREXATE~SOLUTION;SUBCUTANEOUS~RASUVO~MEDAC PHARMA INC~15MG/0.30ML (15MG/0.3
0ML)~N~205776~004~~Jul 10, 2014~No~RX~MEDAC PHARMA INC
METHOTREXATE~SOLUTION;SUBCUTANEOUS~RASUVO~MEDAC PHARMA INC~20MG/0.4ML (20MG/0.4M
L)~N~205776~006~~Jul 10, 2014~No~RX~MEDAC PHARMA INC
METHYLNALTREXONE BROMIDE~SOLUTION;SUBCUTANEOUS~RELISTOR~SALIX PHARMS~12MG/0.6ML
(12MG/0.6ML)~N~021964~001~~Apr 24, 2008~Yes~RX~SALIX PHARMACEUTICALS INC
LIRAGLUTIDE RECOMBINANT~SOLUTION;SUBCUTANEOUS~SAXENDA~NOVO NORDISK INC~18MG/3ML
(6MG/ML)~N~206321~001~~Dec 23, 2014~Yes~RX~NOVO NORDISK INC

PASIREOTIDE DIASPARTATE~SOLUTION;SUBCUTANEOUS~SIGNIFOR~NOVARTIS~EQ 0.3MG BASE/ML
(EQ 0.3MG BASE/ML)~N~200677~001~~Dec 14, 2012~No~RX~NOVARTIS PHARMACEUTICALS CO
RP
(EQ 0.6MG BASE/ML)~N~200677~002~~Dec 14, 2012~No~RX~NOVARTIS PHARMACEUTICALS CO
RP
(EQ 0.9MG BASE/ML)~N~200677~003~~Dec 14, 2012~Yes~RX~NOVARTIS PHARMACEUTICALS C
ORP
LANREOTIDE ACETATE~SOLUTION;SUBCUTANEOUS~SOMATULINE DEPOT~IPSEN PHARMA~EQ 60MG B
ASE/0.2ML (EQ 60MG BASE/0.2ML)~N~022074~001~~Aug 30, 2007~Yes~RX~IPSEN PHARMA BI
OTECH SAS
LANREOTIDE ACETATE~SOLUTION;SUBCUTANEOUS~SOMATULINE DEPOT~IPSEN PHARMA~EQ 90MG B
ASE/0.3ML (EQ 90MG BASE/0.3ML)~N~022074~002~~Aug 30, 2007~Yes~RX~IPSEN PHARMA BI
OTECH SAS
LANREOTIDE ACETATE~SOLUTION;SUBCUTANEOUS~SOMATULINE DEPOT~IPSEN PHARMA~EQ 120MG
BASE/0.5ML (EQ 120MG BASE/0.5ML)~N~022074~003~~Aug 30, 2007~Yes~RX~IPSEN PHARMA
BIOTECH SAS
INSULIN GLARGINE RECOMBINANT~SOLUTION;SUBCUTANEOUS~TOUJEO SOLOSTAR~SANOFI US SER
VICES~300UNITS/ML (300UNITS/ML)~N~206538~001~~Feb 25, 2015~Yes~RX~SANOFI US SERV
ICES INC
LIRAGLUTIDE RECOMBINANT~SOLUTION;SUBCUTANEOUS~VICTOZA~NOVO NORDISK INC~18MG/3ML
(6MG/ML)~N~022341~001~~Jan 25, 2010~Yes~RX~NOVO NORDISK INC
ERYTHROMYCIN~SOLUTION;TOPICAL~A/T/S~TARO PHARMS NORTH~2%~A~062405~001~~Nov 18, 1
982~No~DISCN~TARO PHARMACEUTICALS NORTH AMERICA INC
ALCOHOL; CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~AVAGARD~3M~61%;1%~N~021074~001
~~Jun 7, 2001~Yes~OTC~3M HEALTH CARE INC
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~BRIAN CARE~SOAPCO~4%~A~071419~001~~Dec
17, 1987~No~OTC~SOAPCO INC
ERYTHROMYCIN~SOLUTION;TOPICAL~C-SOLVE-2~FOUGERA PHARMS~2%~A~062468~001~AT~Jul 3,
CALCIPOTRIENE~SOLUTION;TOPICAL~CALCIPOTRIENE~FOUGERA PHARMS~0.005%~A~078305~001~
AT~May 6, 2008~No~RX~FOUGERA PHARMACEUTICALS INC
CALCIPOTRIENE~SOLUTION;TOPICAL~CALCIPOTRIENE~G AND W LABS INC~0.005%~A~078468~00
1~AT~Mar 24, 2011~No~RX~G AND W LABORATORIES INC
CALCIPOTRIENE~SOLUTION;TOPICAL~CALCIPOTRIENE~HI TECH PHARMA~0.005%~A~077579~001~
AT~Nov 19, 2009~No~RX~HI TECH PHARMACAL CO INC
CALCIPOTRIENE~SOLUTION;TOPICAL~CALCIPOTRIENE~TOLMAR~0.005%~A~077029~001~AT~Nov 2
0, 2009~Yes~RX~TOLMAR INC
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~CHG SCRUB~ECOLAB~4%~N~019258~002~~Jul 2
2, 1986~No~OTC~ECOLAB INC
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~ACTAVIS MID ATLANTIC~8%~A~078046~001~AT~S
ep 18, 2007~No~RX~ACTAVIS MID ATLANTIC LLC
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~APOTEX INC~8%~A~078172~001~~Sep 18, 2007~
No~DISCN~APOTEX INC
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~CIPLA LTD~8%~A~078124~001~AT~Sep 18, 2007
~No~RX~CIPLA LTD
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~G AND W LABS~8%~A~078233~001~AT~Sep 18, 2
007~No~RX~G AND W LABORATORIES INC
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~HI TECH PHARMA~8%~A~078270~001~AT~Sep 18,
2007~No~RX~HI TECH PHARMACAL CO INC
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~MYLAN PHARMS INC~8%~A~078567~001~~Sep 18,
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~PERRIGO NEW YORK~8%~A~077623~001~AT~Sep 1
8, 2007~No~RX~PERRIGO NEW YORK INC
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~TARO PHARM INDS~8%~A~078144~001~AT~Sep 18
, 2007~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~TEVA PHARMS~8%~A~078079~001~~Sep 18, 2007
~No~DISCN~TEVA PHARMACEUTICALS USA
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~TOLMAR~8%~A~077687~001~AT~Sep 18, 2007~No

~RX~TOLMAR INC
CICLOPIROX~SOLUTION;TOPICAL~CICLOPIROX~VERSAPHARM~8%~A~078975~001~AT~Feb 17, 201
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~CIDA-STAT~ECOLAB~2%~N~019258~001~~Jul 2
2, 1986~No~OTC~ECOLAB INC
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLEOCIN T~PHARMACIA AND UPJOHN~EQ 1% BASE
~A~062363~001~~Feb 8, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLEOCIN T~PHARMACIA AND UPJOHN~EQ 1% BASE
~N~050537~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDA-DERM~PADDOCK LLC~EQ 1% BASE~A~0633
29~001~AT~Sep 30, 1992~No~RX~PADDOCK LABORATORIES LLC
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~BOCA PHARMA LLC~EQ
1% BASE~A~062944~001~~Jan 11, 1989~No~DISCN~BOCA PHARMACAL LLC
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~FOUGERA~EQ 1% BASE~
A~064159~001~AT~Jun 5, 1997~No~RX~E FOUGERA DIV ALTANA INC
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~FOUGERA PHARMS~EQ 1
% BASE~A~065254~001~AT~Feb 14, 2006~No~RX~FOUGERA PHARMACEUTICALS INC
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~G AND W LABS INC~EQ
1% BASE~A~062811~001~AT~Sep 1, 1988~No~RX~G AND W LABORATORIES INC
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~PERRIGO NEW YORK~EQ
1% BASE~A~064050~001~AT~Nov 30, 1995~No~RX~PERRIGO NEW YORK INC
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~RENAISSANCE PHARMA~
EQ 1% BASE~A~064108~001~~Sep 27, 1996~No~DISCN~RENAISSANCE PHARMA US HOLDINGS IN
C
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~TARO PHARM INDS~EQ
1% BASE~A~065184~001~AT~Mar 31, 2004~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~VINTAGE PHARMS~EQ 1
% BASE~A~062930~001~~Jun 28, 1989~No~DISCN~VINTAGE PHARMACEUTICALS
CLINDAMYCIN PHOSPHATE~SOLUTION;TOPICAL~CLINDAMYCIN PHOSPHATE~WOCKHARDT~EQ 1% BAS
E~A~063304~001~AT~Jul 15, 1997~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
CLOBETASOL PROPIONATE~SOLUTION;TOPICAL~CLOBETASOL PROPIONATE~FOUGERA PHARMS~0.05
%~A~075391~001~AT~Feb 8, 1999~No~RX~FOUGERA PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~SOLUTION;TOPICAL~CLOBETASOL PROPIONATE~G AND W LABS INC~0.
CLOBETASOL PROPIONATE~SOLUTION;TOPICAL~CLOBETASOL PROPIONATE~TARO~0.05%~A~075224
~001~AT~Nov 16, 1998~No~RX~TARO PHARMACEUTICALS INC
CLOBETASOL PROPIONATE~SOLUTION;TOPICAL~CLOBETASOL PROPIONATE~TARO~0.05%~A~075363
~001~AT~Dec 29, 2000~No~RX~TARO PHARMACEUTICALS USA INC
CLOBETASOL PROPIONATE~SOLUTION;TOPICAL~CLOBETASOL PROPIONATE~TOLMAR~0.05%~A~0769
77~001~AT~Aug 5, 2005~No~RX~TOLMAR INC
CLOBETASOL PROPIONATE~SOLUTION;TOPICAL~CLOBETASOL PROPIONATE~WOCKHARDT~0.05%~A~0
CLOTRIMAZOLE~SOLUTION;TOPICAL~CLOTRIMAZOLE~TARO~1%~A~074580~001~AT~Jul 29, 1996~
Yes~RX~TARO PHARMACEUTICALS INC
CLOTRIMAZOLE~SOLUTION;TOPICAL~CLOTRIMAZOLE~TEVA~1%~A~073306~001~AT~Feb 28, 1995~
PODOFILOX~SOLUTION;TOPICAL~CONDYLOX~ACTAVIS LABS UT INC~0.5%~N~019795~001~AT~Dec
13, 1990~Yes~RX~ACTAVIS LABORATORIES UT INC
HEXYLCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~CYCLAINE~MERCK~5%~N~008472~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
HEXACHLOROPHENE~SOLUTION;TOPICAL~DIAL~DIAL~0.25%~N~017421~002~~Approved Prior to
Jan 1, 1982~No~DISCN~DIAL CORP DIV GREYHOUND CO
DICLOFENAC SODIUM~SOLUTION;TOPICAL~DICLOFENAC SODIUM~APOTEX INC~1.5%~A~202027~00
1~AT~May 27, 2014~No~RX~APOTEX INC
DICLOFENAC SODIUM~SOLUTION;TOPICAL~DICLOFENAC SODIUM~PADDOCK LLC~1.5%~A~202393~0
01~AT~Nov 24, 2014~No~RX~PADDOCK LABORATORIES LLC
DICLOFENAC SODIUM~SOLUTION;TOPICAL~DICLOFENAC SODIUM~TARO~1.5%~A~203818~001~AT~N
ov 26, 2014~No~RX~TARO PHARMACEUTICALS USA INC
DICLOFENAC SODIUM~SOLUTION;TOPICAL~DICLOFENAC SODIUM~WATSON LABS INC~1.5%~A~2028
52~001~AT~Nov 24, 2014~No~RX~WATSON LABORATORIES INC

ADAPALENE~SOLUTION;TOPICAL~DIFFERIN~GALDERMA LABS LP~0.1%~N~020338~001~~May 31,
1996~No~DISCN~GALDERMA LABORATORIES LP
CALCIPOTRIENE~SOLUTION;TOPICAL~DOVONEX~LEO PHARM~0.005% **Federal Register deter
easons**~N~020611~001~~Mar 3, 1997~No~DISCN~LEO PHARMACEUTICAL PRODUCTS LTD
DYCLONINE HYDROCHLORIDE~SOLUTION;TOPICAL~DYCLONE~ASTRAZENECA~0.5% **Federal Regi
efficacy reasons**~N~009925~002~~Approved Prior to Jan 1, 1982~No~DISCN~ASTRAZEN
ECA LP
DYCLONINE HYDROCHLORIDE~SOLUTION;TOPICAL~DYCLONE~ASTRAZENECA~1% **Federal Regist
ficacy reasons**~N~009925~001~~Approved Prior to Jan 1, 1982~No~DISCN~ASTRAZENEC
A LP
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~DYNA-HEX~BAJAJ MEDICAL LLC~0.75%~N~0201
11~001~~Sep 11, 1997~No~OTC~BAJAJ MECICAL LLC
POVIDONE-IODINE~SOLUTION;TOPICAL~E-Z PREP~CLINIPAD~10%~N~019382~001~~Jul 25, 198
9~No~DISCN~CLINIPAD CORP
FLUOROURACIL~SOLUTION;TOPICAL~EFUDEX~VALEANT PHARM INTL~2%~N~016831~001~AT~Appro
ved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
FLUOROURACIL~SOLUTION;TOPICAL~EFUDEX~VALEANT PHARM INTL~5%~N~016831~002~AT~Appro
ved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
CLOBETASOL PROPIONATE~SOLUTION;TOPICAL~EMBELINE~HI TECH PHARMA~0.05%~A~074222~00
1~AT~Dec 6, 1995~Yes~RX~HI TECH PHARMACAL CO INC
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYDERM~ARBOR PHARMS INC~2%~A~062290~001~~Approved
Prior to Jan 1, 1982~No~DISCN~ARBOR PHARMACEUTICALS INC
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYMAX~MERZ PHARMS~2%~A~062508~002~~Jul 11, 1985~N
o~DISCN~MERZ PHARMACEUTICALS LLC
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHRA-DERM~PADDOCK LLC~2%~A~062687~001~AT~Feb 5,
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHRO-STATIN~HI TECH PHARMA~2%~A~064101~001~AT~O
ct 22, 1996~No~RX~HI TECH PHARMACAL CO INC
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~ALPHARMA US PHARMS~1.5%~A~062328~001~
~Apr 19, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~ALPHARMA US PHARMS~2%~A~062326~001~~A
pr 19, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~ALPHARMA US PHARMS~2%~A~062327~001~~A
pr 19, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~ALPHARMA US PHARMS~2%~A~062342~001~~F
eb 25, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~ALPHARMA US PHARMS~2%~A~062957~001~~J
ul 21, 1988~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~BAUSCH AND LOMB~2%~A~064039~001~~Jan
27, 1994~No~DISCN~BAUSCH AND LOMB PHARMACEUTICALS INC
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~FOUGERA PHARMS~2%~A~064187~001~AT~Sep
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~LILLY~2%~N~050532~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~PERRIGO NEW YORK~2%~A~063038~001~AT~J
an 11, 1991~No~RX~PERRIGO NEW YORK INC
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~PHARMAFAIR~1.5%~A~062485~001~~Jul 11,
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~PHARMAFAIR~2%~A~062616~001~~Jul 25, 1
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~RENAISSANCE PHARMA~2%~A~064127~001~~F
eb 14, 1997~No~DISCN~RENAISSANCE PHARMA US HOLDINGS INC
ERYTHROMYCIN~SOLUTION;TOPICAL~ERYTHROMYCIN~WOCKHARDT~2%~A~062825~001~AT~Oct 23,
SULCONAZOLE NITRATE~SOLUTION;TOPICAL~EXELDERM~RANBAXY~1%~N~018738~001~~Aug 30, 1
985~Yes~RX~RANBAXY LABORATORIES INC
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~EXIDINE~XTTRIUM~2%~N~019422~001~~Dec 17
, 1985~Yes~OTC~XTTRIUM LABORATORIES INC
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~EXIDINE~XTTRIUM~2.5%~N~019421~001~~Dec
17, 1985~No~DISCN~XTTRIUM LABORATORIES INC
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~EXIDINE~XTTRIUM~4%~N~019125~001~~Dec 24
, 1984~No~OTC~XTTRIUM LABORATORIES INC
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUOCINOLONE ACETONIDE~ALPHARMA US PHARM
S~0.01%~A~087159~001~~Jun 16, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUOCINOLONE ACETONIDE~BAUSCH AND LOMB~0
.01%~A~040059~001~~Dec 20, 1993~No~DISCN~BAUSCH AND LOMB PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUOCINOLONE ACETONIDE~FOUGERA~0.01%~A~0
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUOCINOLONE ACETONIDE~MORTON GROVE~0.01
%~A~088312~001~~Jan 27, 1984~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUOCINOLONE ACETONIDE~PHARMADERM~0.01%~
A~088048~001~~Dec 16, 1982~No~DISCN~PHARMADERM DIV ALTANA INC
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUOCINOLONE ACETONIDE~PHARMAFAIR~0.01%~
A~088449~001~~Feb 8, 1984~No~DISCN~PHARMAFAIR INC
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUOCINOLONE ACETONIDE~TARO~0.01%~A~0891
24~001~AT~Sep 11, 1985~No~RX~TARO PHARMACEUTICALS USA INC
FLUOCINONIDE~SOLUTION;TOPICAL~FLUOCINONIDE~FOUGERA~0.05%~A~072934~001~AT~Feb 27,
1995~No~RX~E FOUGERA DIV ALTANA INC
FLUOCINONIDE~SOLUTION;TOPICAL~FLUOCINONIDE~G AND W LABS INC~0.05%~A~071535~001~A
T~Dec 2, 1988~No~RX~G AND W LABORATORIES INC
FLUOCINONIDE~SOLUTION;TOPICAL~FLUOCINONIDE~TARO~0.05%~A~072857~001~~Aug 2, 1989~
FLUOCINONIDE~SOLUTION;TOPICAL~FLUOCINONIDE~TARO~0.05%~A~074799~001~AT~Dec 31, 19
96~Yes~RX~TARO PHARMACEUTICALS INC
FLUOCINONIDE~SOLUTION;TOPICAL~FLUOCINONIDE~TEVA~0.05%~A~072511~001~AT~Feb 7, 198
FLUOCINONIDE~SOLUTION;TOPICAL~FLUOCINONIDE~TEVA PHARMS~0.05%~A~072522~001~~Sep 2
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUONID~ALLERGAN HERBERT~0.01%~A~087158~
001~~Mar 17, 1983~No~DISCN~ALLERGAN HERBERT DIV ALLERGAN INC
FLUOROURACIL~SOLUTION;TOPICAL~FLUOROPLEX~ELORAC~1%~N~016765~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ELORAC INC
FLUOROURACIL~SOLUTION;TOPICAL~FLUOROURACIL~TARO~2%~A~076526~001~AT~Nov 5, 2003~N
FLUOROURACIL~SOLUTION;TOPICAL~FLUOROURACIL~TARO~5%~A~076526~002~AT~Nov 5, 2003~N
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~FLUOTREX~SAVAGE LABS~0.01%~A~088171~001~
~Mar 9, 1983~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
HEXACHLOROPHENE~SOLUTION;TOPICAL~GERMA-MEDICA~HUNTINGTON LABS~1%~N~017412~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~HUNTINGTON LABORATORIES INC
HEXACHLOROPHENE~SOLUTION;TOPICAL~"GERMA-MEDICA ""MG"""~HUNTINGTON LABS~0.25%~N~0
17412~002~~Approved Prior to Jan 1, 1982~No~DISCN~HUNTINGTON LABORATORIES INC
HALCINONIDE~SOLUTION;TOPICAL~HALOG~RANBAXY~0.1%~N~017823~001~~Approved Prior to
Jan 1, 1982~No~DISCN~RANBAXY LABORATORIES INC
HALOPROGIN~SOLUTION;TOPICAL~HALOTEX~WESTWOOD SQUIBB~1%~N~016943~001~~Approved Pr
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~HIBICLENS~MOLNLYCKE HLTH~4%~N~017768~00
1~~Approved Prior to Jan 1, 1982~Yes~OTC~MOLNLYCKE HEALTH CARE
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~HIBISTAT~MOLNLYCKE HLTH~0.5%~N~018300~0
01~~Approved Prior to Jan 1, 1982~Yes~OTC~MOLNLYCKE HEALTH CARE
HYDROCORTISONE BUTYRATE~SOLUTION;TOPICAL~HYDROCORTISONE BUTYRATE~TARO PHARM INDS
~0.1%~A~076364~001~AT~Jan 14, 2004~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
EFINACONAZOLE~SOLUTION;TOPICAL~JUBLIA~DOW PHARM~10%~N~203567~001~~Jun 6, 2014~Ye
s~RX~DOW PHARMACEUTICAL SCIENCES
TAVABOROLE~SOLUTION;TOPICAL~KERYDIN~ANACOR PHARMS INC~5%~N~204427~001~~Jul 7, 20
14~Yes~RX~ANACOR PHARMACEUTICALS INC
TERBINAFINE HYDROCHLORIDE~SOLUTION;TOPICAL~LAMISIL~NOVARTIS~1%~N~020749~001~~Oct
17, 1997~No~DISCN~NOVARTIS CONSUMER HEALTH INC
TERBINAFINE HYDROCHLORIDE~SOLUTION;TOPICAL~LAMISIL AT~NOVARTIS~1%~N~021124~001~~
Mar 17, 2000~Yes~OTC~NOVARTIS CONSUMER HEALTH INC
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LARYNG-O-JET KIT~INTL MEDICATION~4%~A~0
86364~001~AT~Approved Prior to Jan 1, 1982~No~RX~INTERNATIONAL MEDICATION SYSTEM
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LARYNGOTRACHEAL ANESTHESIA KIT~KENDALL
IL~4%~A~087931~001~~Jun 10, 1983~No~DISCN~KENDALL CO
AMINOLEVULINIC ACID HYDROCHLORIDE~SOLUTION;TOPICAL~LEVULAN~DUSA~20%~N~020965~001
~~Dec 3, 1999~Yes~RX~DUSA PHARMACEUTICALS INC
FLUOCINONIDE~SOLUTION;TOPICAL~LIDEX~CNTY LINE PHARMS~0.05%~N~018849~001~AT~Apr 6
, 1984~No~RX~COUNTY LINE PHARMACEUTICALS LLC
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LIDOCAINE HYDROCHLORIDE~IGI LABS INC~4%
~A~204494~001~AT~Mar 12, 2014~No~RX~IGI LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LIDOCAINE HYDROCHLORIDE~PACO~4%~A~08968
8~001~~Jun 30, 1989~No~DISCN~PACO RESEARCH CORP
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LIDOCAINE HYDROCHLORIDE~ROXANE~4%~A~088
803~001~AT~Apr 3, 1985~No~RX~ROXANE LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LIDOCAINE HYDROCHLORIDE~VINTAGE~4%~A~04
0710~001~AT~Feb 27, 2007~No~RX~VINTAGE PHARMACEUTICALS LLC
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LIDOCAINE HYDROCHLORIDE~WOCKHARDT~4%~A~
HYDROCORTISONE BUTYRATE~SOLUTION;TOPICAL~LOCOID~PRECISION DERMAT~0.1%~N~019116~0
01~AT~Feb 25, 1987~Yes~RX~PRECISION DERMATOLOGY INC
HYDROCORTISONE BUTYRATE~SOLUTION;TOPICAL~LOCOID~YAMANOUCHI~0.1%~N~019819~001~~Se
p 15, 1988~No~DISCN~YAMANOUCHI EUROPE BV
CLOTRIMAZOLE~SOLUTION;TOPICAL~LOTRIMIN~SCHERING PLOUGH~1%~N~017613~001~~Approved
Prior to Jan 1, 1982~No~DISCN~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LTA II KIT~HOSPIRA~4%~A~080409~001~AT~A
pproved Prior to Jan 1, 1982~No~RX~HOSPIRA INC
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~LTA II KIT~HOSPIRA~4%~A~088542~001~~Jul
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~MICRODERM~J AND J~4%~A~072255~001~~Apr
15, 1991~No~DISCN~JOHNSON AND JOHNSON MEDICAL INC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~ACTAVIS MID ATLANTIC~2%~A~074588~
001~~Apr 5, 1996~No~OTC~ACTAVIS MID ATLANTIC LLC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~APOTEX INC~2%~A~074924~001~~Apr 2
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~BAUSCH AND LOMB~2%~A~074643~001~~
Apr 9, 1996~No~DISCN~BAUSCH AND LOMB INC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~COPLEY PHARM~2%~A~074500~001~~May
23, 1996~No~DISCN~COPLEY PHARMACEUTICAL INC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~HI TECH PHARMA~2%~A~074731~001~~D
ec 24, 1996~No~OTC~HI TECH PHARMACAL CO INC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~PERRIGO~2%~A~075357~001~~Jul 30,
1999~No~OTC~PERRIGO CO
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~SIGHT PHARMS~2%~A~074743~002~~Oct
18, 1996~No~DISCN~SIGHT PHARMACEUTICALS INC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~TEVA~2%~A~074589~001~~Apr 5, 1996
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR MEN)~WOCKHARDT~2%~A~074767~001~~Feb 28
, 1997~No~OTC~WOCKHARDT EU OPERATIONS (SWISS) AG
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR WOMEN)~APOTEX INC~2%~A~074924~002~~Apr
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR WOMEN)~HI TECH PHARMA~2%~A~074731~002~
~May 11, 2005~No~OTC~HI TECH PHARMACAL CO INC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR WOMEN)~PERRIGO~2%~A~075357~002~~Jul 30
, 1999~No~OTC~PERRIGO CO
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL (FOR WOMEN)~SIGHT PHARMS~2%~A~074743~001~~O
ct 18, 1996~No~DISCN~SIGHT PHARMACEUTICALS INC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL EXTRA STRENGTH (FOR MEN)~ACTAVIS MID ATLANT

IC~5%~A~075518~001~~Nov 17, 2000~No~OTC~ACTAVIS MID ATLANTIC LLC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL EXTRA STRENGTH (FOR MEN)~APOTEX INC~5%~A~07
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL EXTRA STRENGTH (FOR MEN)~AVACOR PRODS~5%~A~
075619~001~~Nov 17, 2000~No~OTC~AVACOR PRODUCTS LLC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL EXTRA STRENGTH (FOR MEN)~PERRIGO~5%~A~07559
8~001~~Jun 13, 2001~No~OTC~L PERRIGO CO
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL EXTRA STRENGTH (FOR MEN)~PERRIGO NEW YORK~5
%~A~075737~001~~Mar 15, 2002~No~OTC~PERRIGO NEW YORK INC
MINOXIDIL~SOLUTION;TOPICAL~MINOXIDIL EXTRA STRENGTH (FOR MEN)~WOCKHARDT~5%~A~075
438~001~~Feb 27, 2003~No~OTC~WOCKHARDT EU OPERATIONS (SWISS) AG
CLOTRIMAZOLE~SOLUTION;TOPICAL~MYCELEX~BAYER HLTHCARE~1%~N~018181~001~~Approved P
rior to Jan 1, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
NITROFURAZONE~SOLUTION;TOPICAL~NITROFURAZONE~PERRIGO NEW YORK~0.2%~A~085130~001~
NITROFURAZONE~SOLUTION;TOPICAL~NITROFURAZONE~WENDT~0.2%~A~087081~001~~Approved P
rior to Jan 1, 1982~No~DISCN~WENDT LABORATORIES INC
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~PEDIATRIC LTA KIT~ABBOTT~2%~A~088572~00
1~~Jul 31, 1984~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~PEDIATRIC LTA KIT~HOSPIRA~2%~A~085995~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~HOSPIRA WORLDWIDE, INC
HYDROCORTISONE~SOLUTION;TOPICAL~PENECORT~ALLERGAN HERBERT~1%~A~088214~001~~Jun 6
, 1984~No~DISCN~ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC
CICLOPIROX~SOLUTION;TOPICAL~PENLAC~VALEANT BERMUDA~8%~N~021022~001~AT~Dec 17, 19
DICLOFENAC SODIUM~SOLUTION;TOPICAL~PENNSAID~HORIZON PHARMA~2%~N~204623~001~~Jan
16, 2014~Yes~RX~HORIZON PHARMA IRELAND LTD
DICLOFENAC SODIUM~SOLUTION;TOPICAL~PENNSAID~NUVO RES INC~1.5%~N~020947~001~AT~No
v 4, 2009~Yes~RX~NUVO RESEARCH INC
PODOFILOX~SOLUTION;TOPICAL~PODOFILOX~PADDOCK LLC~0.5%~A~075600~001~AT~Jan 29, 20
PODOFILOX~SOLUTION;TOPICAL~PODOFILOX~PRECISION DERMAT~0.5%~A~090184~001~AT~Jul 2
1, 2010~No~RX~PRECISION DERMATOLOGY INC
POVIDONE-IODINE~SOLUTION;TOPICAL~POVIDONE IODINE~ALLEGIANCE HLTHCARE~1%~N~019522
~001~~Mar 31, 1989~Yes~OTC~ALLEGIANCE HEALTHCARE CORP
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~PREVACARE R~J AND J~0.5%~A~072292~001~~
Jan 28, 1992~No~DISCN~JOHNSON AND JOHNSON MEDICAL INC
TRETINOIN~SOLUTION;TOPICAL~RETIN-A~VALEANT INTL~0.05%~N~016921~001~~Approved Pri
or to Jan 1, 1982~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
MINOXIDIL~SOLUTION;TOPICAL~ROGAINE (FOR MEN)~JOHNSON AND JOHNSON~2%~N~019501~002
~~Feb 9, 1996~Yes~OTC~JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
MINOXIDIL~SOLUTION;TOPICAL~ROGAINE (FOR WOMEN)~JOHNSON AND JOHNSON~2%~N~019501~0
03~~Feb 9, 1996~Yes~OTC~JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
MINOXIDIL~SOLUTION;TOPICAL~ROGAINE EXTRA STRENGTH (FOR MEN)~JOHNSON AND JOHNSON~
5%~N~020834~001~~Nov 14, 1997~Yes~OTC~JOHNSON AND JOHNSON GROUP CONSUMER COMPANI
ES
ERYTHROMYCIN~SOLUTION;TOPICAL~SANSAC~DOW PHARM~2%~A~062522~001~~Jan 24, 1985~No~
DISCN~DOW PHARMACEUTICAL SCIENCES
HEXACHLOROPHENE~SOLUTION;TOPICAL~SEPTI-SOFT~CALGON~0.25%~N~017460~001~~Approved
Prior to Jan 1, 1982~No~DISCN~CALGON CORP DIV MERCK AND CO INC
HEXACHLOROPHENE~SOLUTION;TOPICAL~SEPTISOL~VESTAL LABS~0.25%~N~017423~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~VESTAL LABORATORIES DIV CHEMED CORP
MEQUINOL; TRETINOIN~SOLUTION;TOPICAL~SOLAGE~AQUA PHARMS~2%;0.01%~N~020922~001~~D
ec 10, 1999~No~DISCN~AQUA PHARMACEUTICALS LLC
ERYTHROMYCIN~SOLUTION;TOPICAL~STATICIN~WESTWOOD SQUIBB~1.5%~N~050526~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~WESTWOOD SQUIBB PHARMACEUTICALS INC
CHLORHEXIDINE GLUCONATE~SOLUTION;TOPICAL~STERI-STAT~MATRIX MEDCL~4%~A~070104~001
~~Jul 24, 1986~No~DISCN~MATRIX MEDICAL CORP
FLUOCINOLONE ACETONIDE~SOLUTION;TOPICAL~SYNALAR~MEDIMETRIKS PHARMS~0.01%~N~01529
6~001~AT~Approved Prior to Jan 1, 1982~Yes~RX~MEDIMETRIKS PHARMACEUTICALS INC

ERYTHROMYCIN~SOLUTION;TOPICAL~T-STAT~WESTWOOD SQUIBB~2%~A~062436~001~~Mar 9, 198
CLOBETASOL PROPIONATE~SOLUTION;TOPICAL~TEMOVATE~FOUGERA PHARMS~0.05% **Federal R
or efficacy reasons**~N~019966~001~~Feb 22, 1990~No~DISCN~FOUGERA PHARMACEUTICAL
S INC
HYDROCORTISONE~SOLUTION;TOPICAL~TEXACORT~MISSION PHARMA~1%~A~080425~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~MISSION PHARMACAL CO
HYDROCORTISONE~SOLUTION;TOPICAL~TEXACORT~MISSION PHARMA~2.5%~A~081271~001~~Apr 1
7, 1992~Yes~RX~MISSION PHARMACAL CO
MINOXIDIL~SOLUTION;TOPICAL~THEROXIDIL~EI INC~2%~A~078176~001~~Nov 9, 2007~No~OTC
~EI INC
MINOXIDIL~SOLUTION;TOPICAL~THEROXIDIL~EI INC~5%~A~076239~001~~Aug 24, 2004~No~OT
C~EI INC
TRETINOIN~SOLUTION;TOPICAL~TRETINOIN~TEVA PHARMS~0.05%~A~074873~001~~Jun 19, 199
TRETINOIN~SOLUTION;TOPICAL~TRETINOIN~WOCKHARDT~0.05%~A~075260~001~~Jan 25, 1999~
No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
LAPYRIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX~SOLUTION;TOPICAL~VIRAC RE
X~CHESEBROUGH PONDS~0.5%;1.8%~N~011914~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~CHESEBROUGH PONDS INC
LIDOCAINE~SOLUTION;TOPICAL~XYLOCAINE~ASTRAZENECA~5%~N~014127~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ASTRAZENECA LP
LIDOCAINE HYDROCHLORIDE~SOLUTION;TOPICAL~XYLOCAINE 4% PRESERVATIVE FREE~FRESENIU
S KABI USA~4%~N~010417~002~AT~Approved Prior to Jan 1, 1982~Yes~RX~FRESENIUS KAB
I USA LLC
DIATRIZOATE SODIUM~SOLUTION;URETERAL~HYPAQUE SODIUM 20%~GE HEALTHCARE~20%~N~0095
DIATRIZOATE MEGLUMINE~SOLUTION;URETERAL~RENO-30~BRACCO~30%~N~010040~021~~Approve
d Prior to Jan 1, 1982~No~DISCN~BRACCO DIAGNOSTICS INC
DIATRIZOATE MEGLUMINE~SOLUTION;URETERAL~UROVIST CYSTO~BAYER HLTHCARE~30%~A~08772
DIATRIZOATE MEGLUMINE~SOLUTION;URETERAL~UROVIST CYSTO PEDIATRIC~BAYER HLTHCARE~3
0%~A~087731~001~~Sep 23, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
DIATRIZOATE MEGLUMINE~SOLUTION;URETHRAL~CYSTOGRAFIN~BRACCO~30%~N~010040~018~~App
roved Prior to Jan 1, 1982~No~RX~BRACCO DIAGNOSTICS INC
DIATRIZOATE MEGLUMINE~SOLUTION;URETHRAL~CYSTOGRAFIN DILUTE~BRACCO~18%~N~010040~0
22~~Nov 9, 1982~No~RX~BRACCO DIAGNOSTICS INC
DIATRIZOATE MEGLUMINE~SOLUTION;URETHRAL~HYPAQUE-CYSTO~GE HEALTHCARE~30%~N~016403
~003~~Approved Prior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
IOHEXOL~SOLUTION;URETHRAL~OMNIPAQUE 70~GE HEALTHCARE~15.1%~N~018956~007~~Jun 1,
1994~No~DISCN~GE HEALTHCARE
CHLORHEXIDINE GLUCONATE~SPONGE;TOPICAL~BIOSCRUB~GRIFFEN~4%~N~019822~001~~Mar 31,
1989~No~OTC~KW GRIFFEN CO
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SPONGE;TOPICAL~CHLORAPREP ONE-STEP~CA
REFUSION~2%;70% (3ML)~N~020832~001~~Jul 14, 2000~Yes~OTC~CAREFUSION 213 LLC
REFUSION~2%;70% (10.5ML)~N~020832~004~~Aug 20, 2003~Yes~OTC~CAREFUSION 213 LLC
REFUSION~2%;70% (26ML)~N~020832~006~~Nov 21, 2006~Yes~OTC~CAREFUSION 213 LLC
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SPONGE;TOPICAL~CHLORAPREP ONE-STEP FR
EPP~CAREFUSION~2%;70% (1.5ML)~N~020832~003~~Apr 26, 2002~Yes~OTC~CAREFUSION 213
LLC
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SPONGE;TOPICAL~CHLORAPREP WITH TINT~C
AREFUSION~2%;70% (26ML)~N~020832~002~~May 3, 2005~Yes~OTC~CAREFUSION 213 LLC
AREFUSION~2%;70% (10.5ML)~N~020832~005~~Apr 3, 2006~Yes~OTC~CAREFUSION 213 LLC
AREFUSION~2%;70% (3ML)~N~020832~007~~Oct 10, 2006~Yes~OTC~CAREFUSION 213 LLC
CHLORHEXIDINE GLUCONATE~SPONGE;TOPICAL~CHLORHEXIDINE GLUCONATE~BECTON DICKINSON~

4%~A~072525~001~~Oct 24, 1989~No~OTC~BECTON DICKINSON AND CO
CHLORHEXIDINE GLUCONATE~SPONGE;TOPICAL~CHLORHEXIDINE GLUCONATE~KENDALL IL~4%~N~0
19490~001~~Mar 27, 1987~No~DISCN~KENDALL CO
IODINE POVACRYLEX; ISOPROPYL ALCOHOL~SPONGE;TOPICAL~DURAPREP~3M~EQ 0.7% IODINE;7
4% (6ML)~N~021586~001~~Sep 29, 2006~Yes~OTC~3M HEALTH CARE INC
IODINE POVACRYLEX; ISOPROPYL ALCOHOL~SPONGE;TOPICAL~DURAPREP~3M~EQ 0.7% IODINE;7
4% (26ML)~N~021586~002~~Sep 29, 2006~Yes~OTC~3M HEALTH CARE INC
POVIDONE-IODINE~SPONGE;TOPICAL~E-Z PREP~CLINIPAD~5%~N~019382~002~~Jul 25, 1989~N
o~DISCN~CLINIPAD CORP
POVIDONE-IODINE~SPONGE;TOPICAL~E-Z PREP 220~CLINIPAD~5%~N~019382~003~~Jul 25, 19
89~No~DISCN~CLINIPAD CORP
CHLORHEXIDINE GLUCONATE~SPONGE;TOPICAL~E-Z SCRUB~BECTON DICKINSON~4%~A~073416~00
1~~Mar 14, 2000~No~DISCN~BECTON DICKINSON SURGICAL SYSTEM
HEXACHLOROPHENE~SPONGE;TOPICAL~E-Z SCRUB~BECTON DICKINSON~450MG~N~017452~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~BECTON DICKINSON AND CO
POVIDONE-IODINE~SPONGE;TOPICAL~E-Z SCRUB 201~BECTON DICKINSON~20%~N~019240~001~~
Nov 29, 1985~Yes~OTC~BECTON DICKINSON AND CO
POVIDONE-IODINE~SPONGE;TOPICAL~E-Z SCRUB 241~BECTON DICKINSON~10%~N~019476~001~~
Jan 7, 1987~Yes~OTC~BECTON DICKINSON AND CO
HEXACHLOROPHENE~SPONGE;TOPICAL~HEXASCRUB~PROF DSPLS~3%~N~018363~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~PROFESSIONAL DISPOSABLES INC
CHLORHEXIDINE GLUCONATE~SPONGE;TOPICAL~HIBICLENS~MOLNLYCKE HLTH~4% **Federal Reg
efficacy reasons**~N~018423~001~~Approved Prior to Jan 1, 1982~No~DISCN~MOLNLYC
KE HEALTH CARE
CHLORHEXIDINE GLUCONATE~SPONGE;TOPICAL~MICRODERM~J AND J~4%~A~072295~001~~Feb 28
, 1991~No~DISCN~JOHNSON AND JOHNSON MEDICAL INC
CHLORHEXIDINE GLUCONATE~SPONGE;TOPICAL~PHARMASEAL SCRUB CARE~CAREFUSION~4%~N~019
793~001~~Dec 2, 1988~Yes~OTC~CAREFUSION 213 LLC
HEXACHLOROPHENE~SPONGE;TOPICAL~PHISO-SCRUB~SANOFI AVENTIS US~3%~N~017446~001~~Ap
HEXACHLOROPHENE~SPONGE;TOPICAL~PRE-OP~DAVIS AND GECK~480MG~N~017433~001~AT~Appro
ved Prior to Jan 1, 1982~Yes~RX~DAVIS AND GECK DIV AMERICAN CYANAMID CO
HEXACHLOROPHENE~SPONGE;TOPICAL~PRE-OP II~DAVIS AND GECK~480MG~N~017433~002~AT~Ap
proved Prior to Jan 1, 1982~No~RX~DAVIS AND GECK DIV AMERICAN CYANAMID CO
HEXACHLOROPHENE~SPONGE;TOPICAL~SCRUBTEAM SURGICAL SPONGEBRUSH~3M~330MG~N~017413~
001~~Approved Prior to Jan 1, 1982~No~DISCN~3M CO
NONOXYNOL-9~SPONGE;VAGINAL~TODAY~MAYER LABS INC~1GM~N~018683~001~~Apr 1, 1983~Ye
s~OTC~MAYER LABORATORIES INC
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE~SPRAY, METERED;INHALATION~COMBIVENT RESPI
MAT~BOEHRINGER INGELHEIM~EQ 0.1MG BASE/INH;0.02MG/INH~N~021747~001~~Oct 7, 2011~
Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
TIOTROPIUM BROMIDE~SPRAY, METERED;INHALATION~SPIRIVA RESPIMAT~BOEHRINGER INGELHE
IM~EQ 0.0025MG BASE/INH~N~021936~001~~Sep 24, 2014~Yes~RX~BOEHRINGER INGELHEIM P
HARMACEUTICALS INC
OLODATEROL HYDROCHLORIDE~SPRAY, METERED;INHALATION~STRIVERDI RESPIMAT~BOEHRINGER
INGELHEIM~EQ 0.0025MG BASE/INH~N~203108~001~~Jul 31, 2014~Yes~RX~BOEHRINGER ING
ELHEIM PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~SPRAY, METERED;NASAL~ALLERNAZE~LUPIN ATLANTIS~0.05MG/SPR
AY~N~020120~001~~Feb 4, 2000~No~DISCN~LUPIN ATLANTIS HOLDING SA SWITZERLAND
AZELASTINE HYDROCHLORIDE~SPRAY, METERED;NASAL~ASTELIN~MEDA PHARMS~EQ 0.125MG BAS
E/SPRAY~N~020114~001~AB~Nov 1, 1996~Yes~RX~MEDA PHARMACEUTICALS INC
AZELASTINE HYDROCHLORIDE~SPRAY, METERED;NASAL~ASTEPRO~MEDA PHARMS~EQ 0.125MG BAS
E/SPRAY~N~022203~001~~Oct 15, 2008~No~DISCN~MEDA PHARMACEUTICALS MEDA PHARMACEUT
ICALS INC
AZELASTINE HYDROCHLORIDE~SPRAY, METERED;NASAL~ASTEPRO~MEDA PHARMS~EQ 0.1876MG BA
SE/SPRAY~N~022371~001~AB~Aug 31, 2009~Yes~RX~MEDA PHARMACEUTICALS INC
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~ATROVENT~BOEHRINGER INGELHEIM~0.021MG/S
PRAY~N~020393~001~AB~Oct 20, 1995~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS IN
C
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~ATROVENT~BOEHRINGER INGELHEIM~0.042MG/S
PRAY~N~020394~001~AB~Oct 20, 1995~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS IN
C
AZELASTINE HYDROCHLORIDE~SPRAY, METERED;NASAL~AZELASTINE HYDROCHLORIDE~APOTEX IN
C~EQ 0.125MG BASE/SPRAY~A~077954~001~AB~Apr 30, 2009~No~RX~APOTEX INC
AZELASTINE HYDROCHLORIDE~SPRAY, METERED;NASAL~AZELASTINE HYDROCHLORIDE~APOTEX IN
C~EQ 0.1876MG BASE/SPRAY~A~201846~001~AB~Aug 31, 2012~No~RX~APOTEX INC
AZELASTINE HYDROCHLORIDE~SPRAY, METERED;NASAL~AZELASTINE HYDROCHLORIDE~PERRIGO I
SRAEL~EQ 0.1876MG BASE/SPRAY~A~202743~001~AB~May 8, 2014~No~RX~PERRIGO ISRAEL PH
ARMACEUTICALS LTD
AZELASTINE HYDROCHLORIDE~SPRAY, METERED;NASAL~AZELASTINE HYDROCHLORIDE~ROXANE~EQ
0.125MG BASE/SPRAY~A~091444~001~AB~Oct 24, 2014~No~RX~ROXANE LABORATORIES INC
AZELASTINE HYDROCHLORIDE~SPRAY, METERED;NASAL~AZELASTINE HYDROCHLORIDE~SUN PHARM
A GLOBAL~EQ 0.125MG BASE/SPRAY~A~090423~001~AB~May 23, 2012~No~RX~SUN PHARMA GLO
BAL FZE
BECLOMETHASONE DIPROPIONATE MONOHYDRATE~SPRAY, METERED;NASAL~BECONASE AQ~GLAXOSM
ITHKLINE~EQ 0.042MG DIPROP/SPRAY~N~019389~001~~Jul 27, 1987~Yes~RX~GLAXOSMITHKLI
NE
BUDESONIDE~SPRAY, METERED;NASAL~BUDESONIDE~APOTEX INC~0.032MG/INH~A~078949~001~A
B~May 12, 2014~No~RX~APOTEX INC RICHMOND HILL
BUTORPHANOL TARTRATE~SPRAY, METERED;NASAL~BUTORPHANOL TARTRATE~MYLAN~1MG/SPRAY~A
~075759~001~AB~Aug 8, 2001~Yes~RX~MYLAN PHARMACEUTICALS INC
BUTORPHANOL TARTRATE~SPRAY, METERED;NASAL~BUTORPHANOL TARTRATE~NOVEX~1MG/SPRAY~A
~075499~001~AB~Dec 4, 2002~No~RX~NOVEX PHARMA
BUTORPHANOL TARTRATE~SPRAY, METERED;NASAL~BUTORPHANOL TARTRATE~ROXANE~1MG/SPRAY~
A~075824~001~AB~Mar 12, 2002~No~RX~ROXANE LABORATORIES INC
CALCITONIN SALMON~SPRAY, METERED;NASAL~CALCITONIN-SALMON~APOTEX INC~200 IU/SPRAY
~A~076396~001~AB~Nov 17, 2008~No~RX~APOTEX INC
CALCITONIN SALMON~SPRAY, METERED;NASAL~CALCITONIN-SALMON~PAR PHARM~200 IU/SPRAY~
A~076979~001~AB~Jun 8, 2009~No~RX~PAR PHARMACEUTICAL INC
CYANOCOBALAMIN~SPRAY, METERED;NASAL~CALOMIST~PAR PHARM~25MCG/SPRAY~N~022102~001~
~Jul 27, 2007~No~DISCN~PAR PHARMACEUTICAL INC
CROMOLYN SODIUM~SPRAY, METERED;NASAL~CROMOLYN SODIUM~ACTAVIS MID ATLANTIC~5.2MG/
SPRAY~A~074800~001~~Jul 26, 2001~No~DISCN~ACTAVIS MID ATLANTIC LLC
CROMOLYN SODIUM~SPRAY, METERED;NASAL~CROMOLYN SODIUM~BAUSCH AND LOMB~5.2MG/SPRAY
~A~075702~001~~Jul 3, 2001~Yes~OTC~BAUSCH AND LOMB PHARMACEUTICALS INC
CROMOLYN SODIUM~SPRAY, METERED;NASAL~CROMOLYN SODIUM~HH AND P~5.2MG/SPRAY~A~0779
76~001~~Sep 7, 2007~No~DISCN~HH AND P LLC
CROMOLYN SODIUM~SPRAY, METERED;NASAL~CROMOLYN SODIUM~PERRIGO~5.2MG/SPRAY~A~07542
7~001~~Dec 12, 2001~No~OTC~L PERRIGO CO
DESMOPRESSIN ACETATE~SPRAY, METERED;NASAL~DDAVP~FERRING PHARMS INC~0.01MG/SPRAY~
N~017922~002~~Feb 6, 1989~No~DISCN~FERRING PHARMACEUTICALS INC
DESMOPRESSIN ACETATE~SPRAY, METERED;NASAL~DDAVP (NEEDS NO REFRIGERATION)~FERRING
PHARMS INC~0.01MG/SPRAY~N~017922~003~AB~Aug 7, 1996~Yes~RX~FERRING PHARMACEUTIC
ALS INC
DESMOPRESSIN ACETATE~SPRAY, METERED;NASAL~DESMOPRESSIN ACETATE~BAUSCH AND LOMB~0
.01MG/SPRAY~A~074830~001~AB~Jan 25, 1999~Yes~RX~BAUSCH AND LOMB PHARMACEUTICALS
INC
DESMOPRESSIN ACETATE~SPRAY, METERED;NASAL~DESMOPRESSIN ACETATE (NEEDS NO REFRIGE
RATION)~APOTEX INC~0.01MG/SPRAY~A~076703~001~AB~Jan 27, 2005~No~RX~APOTEX INC RI
CHMOND HILL
DESMOPRESSIN ACETATE~SPRAY, METERED;NASAL~DESMOPRESSIN ACETATE (NEEDS NO REFRIGE
RATION)~SUN PHARMA GLOBAL~0.01MG/SPRAY~A~078271~001~AB~Dec 23, 2013~No~RX~SUN PH
ARMA GLOBAL FZE
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE~SPRAY, METERED;NASAL~DYMISTA~ME
DA PHARMS~EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY~N~202236~001~~May 1, 2012~Yes~RX~ME
DA PHARMACEUTICALS
FLUTICASONE PROPIONATE~SPRAY, METERED;NASAL~FLONASE~GLAXOSMITHKLINE~0.05MG/SPRAY
~N~020121~001~AB~Oct 19, 1994~Yes~RX~GLAXOSMITHKLINE
FLUTICASONE PROPIONATE~SPRAY, METERED;NASAL~FLONASE ALLERGY RELIEF~GLAXOSMITHKLI

NE CONS~0.05MG/SPRAY~N~205434~001~~Jul 23, 2014~Yes~OTC~GLAXOSMITHKLINE CONSUMER
HEALTHCARE
FLUNISOLIDE~SPRAY, METERED;NASAL~FLUNISOLIDE~APOTEX INC~0.029MG/SPRAY~A~077436~0
01~~Aug 9, 2007~Yes~RX~APOTEX INC RICHMOND HILL
FLUNISOLIDE~SPRAY, METERED;NASAL~FLUNISOLIDE~BAUSCH AND LOMB~0.025MG/SPRAY~A~074
805~001~AB~Feb 20, 2002~Yes~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
FLUNISOLIDE~SPRAY, METERED;NASAL~FLUNISOLIDE~HI TECH PHARMA CO~0.025MG/SPRAY~A~0
77704~001~AB~Aug 3, 2006~No~RX~HI TECH PHARMACAL CO INC
FLUTICASONE PROPIONATE~SPRAY, METERED;NASAL~FLUTICASONE PROPIONATE~APOTEX INC~0.
05MG/SPRAY~A~077538~001~AB~Sep 12, 2007~No~RX~APOTEX INC RICHMOND HILL
FLUTICASONE PROPIONATE~SPRAY, METERED;NASAL~FLUTICASONE PROPIONATE~HI TECH PHARM
A~0.05MG/SPRAY~A~077570~001~AB~Jan 16, 2008~No~RX~HI TECH PHARMACAL CO INC
FLUTICASONE PROPIONATE~SPRAY, METERED;NASAL~FLUTICASONE PROPIONATE~ROXANE~0.05MG
/SPRAY~A~076504~001~AB~Feb 22, 2006~No~RX~ROXANE LABORATORIES INC
FLUTICASONE PROPIONATE~SPRAY, METERED;NASAL~FLUTICASONE PROPIONATE~WOCKHARDT~0.0
5MG/SPRAY~A~078492~001~AB~Jan 9, 2012~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
CALCITONIN SALMON RECOMBINANT~SPRAY, METERED;NASAL~FORTICAL~UPSHER SMITH~200 IU/
SPRAY~N~021406~001~~Aug 12, 2005~Yes~RX~UPSHER SMITH LABORATORIES INC
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~IPRATROPIUM BROMIDE~APOTEX INC~0.021MG/
SPRAY~A~076156~001~~Apr 18, 2003~No~DISCN~APOTEX INC
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~IPRATROPIUM BROMIDE~APOTEX INC~0.042MG/
SPRAY~A~076155~001~~Apr 18, 2003~No~DISCN~APOTEX INC
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~IPRATROPIUM BROMIDE~BAUSCH AND LOMB~0.0
21MG/SPRAY~A~076025~001~AB~Mar 31, 2003~No~RX~BAUSCH AND LOMB PHARMACEUTICALS IN
C
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~IPRATROPIUM BROMIDE~BAUSCH AND LOMB~0.0
42MG/SPRAY~A~076103~001~AB~Mar 31, 2003~No~RX~BAUSCH AND LOMB INC
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~IPRATROPIUM BROMIDE~MYLAN SPECLT~0.021M
G/SPRAY~A~075552~001~AB~Mar 31, 2003~No~RX~MYLAN SPECIALTY LP
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~IPRATROPIUM BROMIDE~MYLAN SPECLT~0.042M
G/SPRAY~A~075553~001~AB~Mar 31, 2003~No~RX~MYLAN SPECIALTY LP
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~IPRATROPIUM BROMIDE~ROXANE~0.021MG/SPRA
Y~A~076664~001~AB~Nov 5, 2003~No~RX~ROXANE LABORATORIES INC
IPRATROPIUM BROMIDE~SPRAY, METERED;NASAL~IPRATROPIUM BROMIDE~ROXANE~0.042MG/SPRA
Y~A~076598~001~AB~Nov 5, 2003~No~RX~ROXANE LABORATORIES INC
FENTANYL CITRATE~SPRAY, METERED;NASAL~LAZANDA~DEPOMED INC~EQ 0.1MG BASE~N~022569
~001~~Jun 30, 2011~No~RX~DEPOMED INC
FENTANYL CITRATE~SPRAY, METERED;NASAL~LAZANDA~DEPOMED INC~EQ 0.4MG BASE~N~022569
~002~~Jun 30, 2011~Yes~RX~DEPOMED INC
CALCITONIN SALMON~SPRAY, METERED;NASAL~MIACALCIN~SEBELA IRELAND LTD~200 IU/SPRAY
~N~020313~002~AB~Aug 17, 1995~Yes~RX~SEBELA IRELAND LTD
DIHYDROERGOTAMINE MESYLATE~SPRAY, METERED;NASAL~MIGRANAL~VALEANT~0.5MG/INH~N~020
148~001~~Dec 8, 1997~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
DESMOPRESSIN ACETATE~SPRAY, METERED;NASAL~MINIRIN~FERRING~0.01MG/SPRAY~N~021333~
001~AB~Sep 16, 2002~Yes~RX~FERRING PHARMACEUTICALS INC
TRIAMCINOLONE ACETONIDE~SPRAY, METERED;NASAL~NASACORT ALLERGY 24 HOUR~SANOFI AVE
NTIS US~0.055MG/SPRAY~N~020468~002~~Oct 11, 2013~Yes~OTC~SANOFI AVENTIS US LLC
TRIAMCINOLONE ACETONIDE~SPRAY, METERED;NASAL~NASACORT HFA~SANOFI AVENTIS US~0.05
5MG/SPRAY~N~020784~001~~Apr 7, 2004~No~DISCN~SANOFI AVENTIS US LLC
CROMOLYN SODIUM~SPRAY, METERED;NASAL~NASALCROM~BLACKSMITH BRANDS~5.2MG/SPRAY **F
safety or efficacy reasons**~N~020463~001~~Jan 3, 1997~No~DISCN~BLACKSMITH BRAN
DS INC
FLUNISOLIDE~SPRAY, METERED;NASAL~NASALIDE~IVAX RES~0.025MG/SPRAY~N~018148~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~IVAX RESEARCH INC
FLUNISOLIDE~SPRAY, METERED;NASAL~NASAREL~TEVA BRANDED PHARM~0.029MG/SPRAY~N~0204
09~001~~Mar 8, 1995~No~DISCN~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
CYANOCOBALAMIN~SPRAY, METERED;NASAL~NASCOBAL~PAR PHARM~0.5MG/SPRAY~N~021642~001~
~Jan 31, 2005~Yes~RX~PAR PHARMACEUTICAL INC
MOMETASONE FUROATE MONOHYDRATE~SPRAY, METERED;NASAL~NASONEX~MERCK SHARP DOHME~EQ

0.05MG BASE/SPRAY~N~020762~001~~Oct 1, 1997~Yes~RX~MERCK SHARP AND DOHME CORP
NICOTINE~SPRAY, METERED;NASAL~NICOTROL~PFIZER INC~0.5MG/SPRAY~N~020385~001~~Mar
OLOPATADINE HYDROCHLORIDE~SPRAY, METERED;NASAL~OLOPATADINE HYDROCHLORIDE~APOTEX
INC~0.665MG/SPRAY~A~091572~001~AB~Oct 8, 2014~No~RX~APOTEX INC
CICLESONIDE~SPRAY, METERED;NASAL~OMNARIS~TAKEDA GMBH~0.05MG/INH~N~022004~001~~Oc
t 20, 2006~Yes~RX~TAKEDA GMBH
OLOPATADINE HYDROCHLORIDE~SPRAY, METERED;NASAL~PATANASE~ALCON PHARMS LTD~0.665MG
/SPRAY~N~021861~001~AB~Apr 15, 2008~Yes~RX~ALCON PHARMACEUTICALS LTD
BUDESONIDE~SPRAY, METERED;NASAL~RHINOCORT~ASTRAZENECA PHARMS~0.032MG/INH~N~02074
6~001~AB~Oct 1, 1999~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
BUDESONIDE~SPRAY, METERED;NASAL~RHINOCORT~ASTRAZENECA PHARMS~0.064MG/INH~N~02074
6~002~~Oct 1, 1999~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
KETOROLAC TROMETHAMINE~SPRAY, METERED;NASAL~SPRIX~EGALET US INC~15.75MG/SPRAY~N~
022382~001~~May 14, 2010~Yes~RX~EGALET US INC
BUTORPHANOL TARTRATE~SPRAY, METERED;NASAL~STADOL~BRISTOL MYERS SQUIBB~1MG/SPRAY~
N~019890~001~~Dec 12, 1991~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEA
RCH INSTITUTE
DESMOPRESSIN ACETATE~SPRAY, METERED;NASAL~STIMATE~CSL BEHRING~0.15MG/SPRAY~N~020
355~001~~Mar 7, 1994~No~DISCN~CSL BEHRING LLC
DESMOPRESSIN ACETATE~SPRAY, METERED;NASAL~STIMATE (NEEDS NO REFRIGERATION)~CSL B
EHRING~1.5MG/SPRAY~N~020355~002~~Oct 24, 2007~Yes~RX~CSL BEHRING LLC
NAFARELIN ACETATE~SPRAY, METERED;NASAL~SYNAREL~GD SEARLE LLC~EQ 0.2MG BASE/SPRAY
~N~019886~001~~Feb 13, 1990~Yes~RX~GD SEARLE LLC
TRIAMCINOLONE ACETONIDE~SPRAY, METERED;NASAL~TRIAMCINOLONE ACETONIDE~TEVA PHARMS
~0.055MG/SPRAY~A~078104~001~~Jul 30, 2009~No~RX~TEVA PHARMACEUTICALS USA
BECLOMETHASONE DIPROPIONATE MONOHYDRATE~SPRAY, METERED;NASAL~VANCENASE AQ~SCHERI
NG~EQ 0.042MG DIPROP/SPRAY~N~019589~001~~Dec 23, 1987~No~DISCN~SCHERING CORP SUB
SCHERING PLOUGH CORP
BECLOMETHASONE DIPROPIONATE MONOHYDRATE~SPRAY, METERED;NASAL~VANCENASE AQ~SCHERI
NG~EQ 0.084MG DIPROP/SPRAY~N~020469~001~~Jun 26, 1996~No~DISCN~SCHERING CORP
FLUTICASONE FUROATE~SPRAY, METERED;NASAL~VERAMYST~GLAXOSMITHKLINE~0.0275MG/INH~N
~022051~001~~Apr 27, 2007~Yes~RX~GLAXOSMITHKLINE
ZOLPIDEM TARTRATE~SPRAY, METERED;ORAL~ZOLPIMIST~NOVADEL~5MG/SPRAY~N~022196~001~~
Dec 19, 2008~Yes~RX~NOVADEL PHARMA INC
NITROGLYCERIN~SPRAY, METERED;SUBLINGUAL~NITROGLYCERIN~PERRIGO ISRAEL~0.4MG/SPRAY
~A~091496~001~AB~Sep 20, 2013~No~RX~PERRIGO ISRAEL PHARMACEUTICALS LTD
NITROGLYCERIN~SPRAY, METERED;SUBLINGUAL~NITROLINGUAL PUMPSPRAY~POHL BOSKAMP~0.4M
G/SPRAY~N~018705~002~AB~Jan 10, 1997~Yes~RX~POHL BOSKAMP
SUMATRIPTAN~SPRAY;NASAL~IMITREX~GLAXOSMITHKLINE~5MG/SPRAY~N~020626~001~~Aug 26,
TETRAHYDROZOLINE HYDROCHLORIDE~SPRAY;NASAL~TYZINE~FOUGERA PHARMS~0.1%~A~086576~0
03~~Approved Prior to Jan 1, 1982~Yes~RX~FOUGERA PHARMACEUTICALS INC
ZOLMITRIPTAN~SPRAY;NASAL~ZOMIG~ASTRAZENECA~2.5MG/SPRAY~N~021450~003~~Sep 16, 201
ZOLMITRIPTAN~SPRAY;NASAL~ZOMIG~ASTRAZENECA~5MG/SPRAY~N~021450~004~~Sep 30, 2003~
Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
FENTANYL~SPRAY;SUBLINGUAL~SUBSYS~INSYS THERAP~0.1MG~N~202788~001~~Jan 4, 2012~No
~RX~INSYS THERAPEUTICS INC
FENTANYL~SPRAY;SUBLINGUAL~SUBSYS~INSYS THERAP~0.4MG~N~202788~003~~Jan 4, 2012~Ye
s~RX~INSYS THERAPEUTICS INC

FENTANYL~SPRAY;SUBLINGUAL~SUBSYS~INSYS THERAP~1.2MG~N~202788~006~~Aug 30, 2012~N
o~RX~INSYS THERAPEUTICS INC
FENTANYL~SPRAY;SUBLINGUAL~SUBSYS~INSYS THERAP~1.6MG~N~202788~007~~Aug 30, 2012~N
o~RX~INSYS THERAPEUTICS INC
CLOBETASOL PROPIONATE~SPRAY;TOPICAL~CLOBETASOL PROPIONATE~PADDOCK LLC~0.05%~A~09
0898~001~AT~Jun 16, 2011~No~RX~PADDOCK LABORATORIES LLC
CLOBETASOL PROPIONATE~SPRAY;TOPICAL~CLOBEX~GALDERMA LABS LP~0.05%~N~021835~001~A
T~Oct 27, 2005~Yes~RX~GALDERMA LABORATORIES LP
TRIAMCINOLONE ACETONIDE~SPRAY;TOPICAL~KENALOG~RANBAXY~0.147MG/GM~N~012104~001~~A
pproved Prior to Jan 1, 1982~Yes~RX~RANBAXY LABORATORIES INC
TERBINAFINE HYDROCHLORIDE~SPRAY;TOPICAL~LAMISIL AT~NOVARTIS~1%~N~021124~002~~Mar
17, 2000~Yes~OTC~NOVARTIS CONSUMER HEALTH INC
DESOXIMETASONE~SPRAY;TOPICAL~TOPICORT~TARO~0.25%~N~204141~001~~Apr 11, 2013~Yes~
RX~TARO PHARMACEUTICALS USA INC
ESTRADIOL~SPRAY;TRANSDERMAL~EVAMIST~ELAN PHARMA INTL LTD~1.53MG/SPRAY~N~022014~0
01~~Jul 27, 2007~Yes~RX~ELAN PHARMA INTERNATIONAL LTD
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACEPHEN~G AND W LABS~120MG~A~072218~001~~Mar 27
, 1992~No~DISCN~G AND W LABORATORIES INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACEPHEN~G AND W LABS~120MG~N~018060~001~~Approv
ed Prior to Jan 1, 1982~No~OTC~G AND W LABORATORIES INC
, 1992~No~OTC~G AND W LABORATORIES INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACEPHEN~G AND W LABS~325MG~N~018060~003~~Dec 18
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACEPHEN~G AND W LABS~650MG~N~018060~002~~Approv
ed Prior to Jan 1, 1982~No~OTC~G AND W LABORATORIES INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACETAMINOPHEN~ABLE~120MG~A~073106~001~~Feb 27,
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACETAMINOPHEN~PERRIGO NEW YORK~120MG~A~070607~0
01~~Apr 6, 1987~No~OTC~PERRIGO NEW YORK INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACETAMINOPHEN~PERRIGO NEW YORK~650MG~A~070608~0
01~~Dec 1, 1986~No~OTC~PERRIGO NEW YORK INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACETAMINOPHEN~ROXANE~120MG~A~071010~001~~May 12
, 1987~No~DISCN~ROXANE LABORATORIES INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACETAMINOPHEN~ROXANE~650MG~A~071011~001~~May 12
, 1987~No~DISCN~ROXANE LABORATORIES INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~ACETAMINOPHEN~TARO PHARMS NORTH~120MG~N~018337~
003~~Sep 12, 1983~No~OTC~TARO PHARMACEUTICALS NORTH AMERICA INC
002~~Approved Prior to Jan 1, 1982~No~OTC~TARO PHARMACEUTICALS NORTH AMERICA INC
001~~Approved Prior to Jan 1, 1982~Yes~OTC~TARO PHARMACEUTICALS NORTH AMERICA IN
C
CAFFEINE; ERGOTAMINE TARTRATE~SUPPOSITORY;RECTAL~CAFERGOT~NOVARTIS~100MG;2MG~N~0
MESALAMINE~SUPPOSITORY;RECTAL~CANASA~FOREST LABS INC~1GM~N~021252~002~~Nov 5, 20
MESALAMINE~SUPPOSITORY;RECTAL~CANASA~FOREST LABS INC~500MG~N~021252~001~~Jan 5,
PROCHLORPERAZINE~SUPPOSITORY;RECTAL~COMPAZINE~GLAXOSMITHKLINE~2.5MG~N~011127~003
~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
PROCHLORPERAZINE~SUPPOSITORY;RECTAL~COMPAZINE~GLAXOSMITHKLINE~5MG~N~011127~001~~
Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE

PROCHLORPERAZINE~SUPPOSITORY;RECTAL~COMPAZINE~GLAXOSMITHKLINE~25MG~N~011127~002~
PROCHLORPERAZINE~SUPPOSITORY;RECTAL~COMPRO~PADDOCK LLC~25MG~A~040246~001~AB~Jun
BENZQUINAMIDE HYDROCHLORIDE~SUPPOSITORY;RECTAL~EMETE-CON~ROERIG~EQ 100MG BASE~N~
INDOMETHACIN~SUPPOSITORY;RECTAL~INDOCIN~IROKO PHARMS~50MG~N~017814~001~~Aug 13,
1984~No~DISCN~IROKO PHARMACEUTICALS LLC
INDOMETHACIN~SUPPOSITORY;RECTAL~INDOMETHACIN~G AND W LABS~50MG~A~073314~001~~Aug
31, 1992~Yes~RX~G AND W LABORATORIES INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~INFANTS' FEVERALL~TARO PHARMS NORTH~80MG~N~0183
37~004~~Aug 26, 1992~No~OTC~TARO PHARMACEUTICALS NORTH AMERICA INC
CAFFEINE; ERGOTAMINE TARTRATE~SUPPOSITORY;RECTAL~MIGERGOT~CREALTA PHARMS LLC~100
MG;2MG~A~086557~001~~Oct 4, 1983~Yes~RX~CREALTA PHARMACEUTICALS LLC
PENTOBARBITAL SODIUM~SUPPOSITORY;RECTAL~NEMBUTAL~OAK PHARMS~30MG~A~083247~001~~J
an 25, 1982~No~DISCN~OAK PHARMACEUTICALS INC
PENTOBARBITAL SODIUM~SUPPOSITORY;RECTAL~NEMBUTAL~OAK PHARMS~60MG~A~083247~002~~J
an 25, 1982~No~DISCN~OAK PHARMACEUTICALS INC
PENTOBARBITAL SODIUM~SUPPOSITORY;RECTAL~NEMBUTAL~OAK PHARMS~120MG~A~083247~003~~
Jan 25, 1982~No~DISCN~OAK PHARMACEUTICALS INC
PENTOBARBITAL SODIUM~SUPPOSITORY;RECTAL~NEMBUTAL~OAK PHARMS~200MG~A~083247~004~~
Jan 25, 1982~No~DISCN~OAK PHARMACEUTICALS INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~NEOPAP~POLYMEDICA~120MG~N~016401~001~~Approved
Prior to Jan 1, 1982~No~OTC~POLYMEDICA INDUSTRIES INC
OXYMORPHONE HYDROCHLORIDE~SUPPOSITORY;RECTAL~NUMORPHAN~ENDO PHARMS~5MG~N~011738~
004~~Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUTICALS INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PHENERGAN~DELCOR ASSET CORP~50MG~N
~011689~001~~Approved Prior to Jan 1, 1982~No~DISCN~DELCOR ASSET CORP
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PHENERGAN~SHIONOGI INC~12.5MG~N~01
0926~002~~Approved Prior to Jan 1, 1982~No~DISCN~SHIONOGI INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PHENERGAN~SHIONOGI INC~25MG~N~0109
26~001~~Approved Prior to Jan 1, 1982~No~DISCN~SHIONOGI INC
PROCHLORPERAZINE~SUPPOSITORY;RECTAL~PROCHLORPERAZINE~ABLE~2.5MG~A~040407~001~~Ju
l 11, 2001~No~DISCN~ABLE LABORATORIES INC
PROCHLORPERAZINE~SUPPOSITORY;RECTAL~PROCHLORPERAZINE~ABLE~5MG~A~040407~002~~Jul
11, 2001~No~DISCN~ABLE LABORATORIES INC
PROCHLORPERAZINE~SUPPOSITORY;RECTAL~PROCHLORPERAZINE~ABLE~25MG~A~040407~003~~Jul
PROCHLORPERAZINE~SUPPOSITORY;RECTAL~PROCHLORPERAZINE~G AND W LABS~25MG~A~040058~
001~AB~Nov 24, 1993~Yes~RX~G AND W LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHACON~POLYMEDICA~25MG~A~0849
01~001~~Approved Prior to Jan 1, 1982~No~DISCN~POLYMEDICA INDUSTRIES INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHACON~POLYMEDICA~50MG~A~0849
02~001~~Approved Prior to Jan 1, 1982~No~DISCN~POLYMEDICA INDUSTRIES INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~ABLE~12
.5MG~A~040504~001~~Apr 11, 2003~No~DISCN~ABLE LABORATORIES INC
MG~A~040504~002~~Apr 11, 2003~No~DISCN~ABLE LABORATORIES INC
MG~A~040449~001~~Feb 27, 2003~No~DISCN~ABLE LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~G AND W
LABS~12.5MG~A~040428~002~AB~Mar 31, 2003~No~RX~G AND W LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~G AND W
LABS~25MG~A~040428~001~AB~Feb 5, 2002~Yes~RX~G AND W LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~PERRIGO
NEW YORK~12.5MG~A~040500~001~AB~Jun 30, 2003~No~RX~PERRIGO NEW YORK INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~PERRIGO
NEW YORK~25MG~A~040500~002~AB~Jun 30, 2003~No~RX~PERRIGO NEW YORK INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~TARO~12
.5MG~A~040603~001~AB~Oct 26, 2006~No~RX~TARO PHARMACEUTICALS USA INC

PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~TARO~25
MG~A~040603~002~AB~Oct 26, 2006~No~RX~TARO PHARMACEUTICALS USA INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~WATSON
LABS INC~12.5MG~A~040479~001~AB~Jun 24, 2003~No~RX~WATSON LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHAZINE HYDROCHLORIDE~WATSON
LABS INC~25MG~A~040479~002~AB~Jun 24, 2003~No~RX~WATSON LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~SUPPOSITORY;RECTAL~PROMETHEGAN~G AND W LABS~50MG~A~08
7165~001~~Aug 14, 1987~Yes~RX~G AND W LABORATORIES INC
MESALAMINE~SUPPOSITORY;RECTAL~ROWASA~MEDA PHARMS~500MG~N~019919~001~~Dec 18, 199
SECOBARBITAL SODIUM~SUPPOSITORY;RECTAL~SECONAL SODIUM~LILLY~30MG~A~086530~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
SECOBARBITAL SODIUM~SUPPOSITORY;RECTAL~SECONAL SODIUM~LILLY~60MG~A~086530~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
SECOBARBITAL SODIUM~SUPPOSITORY;RECTAL~SECONAL SODIUM~LILLY~120MG~A~086530~003~~
Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
SECOBARBITAL SODIUM~SUPPOSITORY;RECTAL~SECONAL SODIUM~LILLY~200MG~A~086530~004~~
CHLORPROMAZINE~SUPPOSITORY;RECTAL~THORAZINE~GLAXOSMITHKLINE~25MG **Federal Regis
fficacy reasons**~N~009149~024~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMIT
HKLINE
CHLORPROMAZINE~SUPPOSITORY;RECTAL~THORAZINE~GLAXOSMITHKLINE~100MG **Federal Regi
efficacy reasons**~N~009149~033~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMI
THKLINE
THIETHYLPERAZINE MALEATE~SUPPOSITORY;RECTAL~TORECAN~NOVARTIS~10MG~N~013247~001~~
Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
AMINOPHYLLINE~SUPPOSITORY;RECTAL~TRUPHYLLINE~G AND W LABS~250MG~A~085498~001~~Ma
r 23, 1983~No~DISCN~G AND W LABORATORIES INC
AMINOPHYLLINE~SUPPOSITORY;RECTAL~TRUPHYLLINE~G AND W LABS~500MG~A~085498~002~~Ja
n 3, 1983~No~DISCN~G AND W LABORATORIES INC
ACETAMINOPHEN~SUPPOSITORY;RECTAL~TYLENOL~MCNEIL CONS~120MG~N~017756~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~MCNEIL CONSUMER HEALTHCARE
ACETAMINOPHEN~SUPPOSITORY;RECTAL~TYLENOL~MCNEIL CONS~650MG~N~017756~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~MCNEIL CONSUMER HEALTHCARE
LIDOCAINE~SUPPOSITORY;RECTAL~XYLOCAINE~ASTRAZENECA~100MG~N~013077~001~~Approved
Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA LP
ALPROSTADIL~SUPPOSITORY;URETHRAL~MUSE~MEDA PHARMS~0.125MG~N~020700~001~~Nov 19,
ALPROSTADIL~SUPPOSITORY;URETHRAL~MUSE~MEDA PHARMS~0.25MG~N~020700~002~~Nov 19, 1
ALPROSTADIL~SUPPOSITORY;URETHRAL~MUSE~MEDA PHARMS~0.5MG~N~020700~003~~Nov 19, 19
ALPROSTADIL~SUPPOSITORY;URETHRAL~MUSE~MEDA PHARMS~1MG~N~020700~004~~Nov 19, 1996
~Yes~RX~MEDA PHARMACEUTICALS INC
SULFANILAMIDE~SUPPOSITORY;VAGINAL~AVC~MEDA PHARMS~1.05GM~N~006530~004~~Jan 27, 1
CLINDAMYCIN PHOSPHATE~SUPPOSITORY;VAGINAL~CLEOCIN~PHARMACIA AND UPJOHN~100MG~N~0
50767~001~~Aug 13, 1999~Yes~RX~PHARMACIA AND UPJOHN CO
DIETHYLSTILBESTROL~SUPPOSITORY;VAGINAL~DIETHYLSTILBESTROL~LILLY~0.1MG~N~004040~0
DIETHYLSTILBESTROL~SUPPOSITORY;VAGINAL~DIETHYLSTILBESTROL~LILLY~0.5MG~N~004040~0
DIENESTROL~SUPPOSITORY;VAGINAL~DV~SANOFI AVENTIS US~0.7MG~A~083517~001~~Approved
BUTOCONAZOLE NITRATE~SUPPOSITORY;VAGINAL~FEMSTAT~ROCHE PALO~100MG~N~019359~001~~
Nov 25, 1985~No~DISCN~ROCHE PALO ALTO LLC
GENTIAN VIOLET~SUPPOSITORY;VAGINAL~GVS~SAVAGE LABS~0.4%~A~083513~001~~Approved P
rior to Jan 1, 1982~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC

MICONAZOLE NITRATE~SUPPOSITORY;VAGINAL~MICONAZOLE NITRATE~ACTAVIS MID ATLANTIC~1
00MG~A~073507~001~~Nov 19, 1993~No~OTC~ACTAVIS MID ATLANTIC LLC
MICONAZOLE NITRATE~SUPPOSITORY;VAGINAL~MICONAZOLE NITRATE~ACTAVIS MID ATLANTIC~2
00MG~A~073508~001~AB~Nov 19, 1993~No~RX~ACTAVIS MID ATLANTIC LLC
MICONAZOLE NITRATE~SUPPOSITORY;VAGINAL~MICONAZOLE NITRATE~G AND W LABS~100MG~A~0
74414~001~~Apr 30, 1997~No~OTC~G AND W LABORATORIES INC
MICONAZOLE NITRATE~SUPPOSITORY;VAGINAL~MICONAZOLE NITRATE~PERRIGO~100MG~A~074395
~001~~Mar 20, 1997~Yes~OTC~L PERRIGO CO
MICONAZOLE NITRATE~SUPPOSITORY;VAGINAL~MONISTAT 3~MEDTECH PRODUCTS~200MG~N~01888
8~001~AB~Aug 15, 1984~Yes~RX~MEDTECH PRODUCTS INC
MICONAZOLE NITRATE~SUPPOSITORY;VAGINAL~MONISTAT 7~MEDTECH PRODUCTS~100MG~N~01852
0~002~~Feb 15, 1991~Yes~OTC~MEDTECH PRODUCTS INC
NYSTATIN~SUPPOSITORY;VAGINAL~NYSERT~WARNER CHILCOTT~100,000 UNITS~N~050478~001~~
Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT CO LLC
DINOPROSTONE~SUPPOSITORY;VAGINAL~PROSTIN E2~PHARMACIA AND UPJOHN~20MG~N~017810~0
01~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
DIETHYLSTILBESTROL~SUPPOSITORY;VAGINAL~STILBESTROL~BRISTOL MYERS SQUIBB~0.1MG~N~
004056~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
DIETHYLSTILBESTROL~SUPPOSITORY;VAGINAL~STILBESTROL~BRISTOL MYERS SQUIBB~0.5MG~N~
004056~002~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
TERCONAZOLE~SUPPOSITORY;VAGINAL~TERAZOL 3~JANSSEN PHARMS~80MG~N~019641~001~AB~Ma
y 24, 1988~Yes~RX~JANSSEN PHARMACEUTICALS INC
TERCONAZOLE~SUPPOSITORY;VAGINAL~TERCONAZOLE~FOUGERA PHARMS~80MG~A~076850~001~~Ju
l 12, 2006~No~DISCN~FOUGERA PHARMACEUTICALS INC
TERCONAZOLE~SUPPOSITORY;VAGINAL~TERCONAZOLE~PERRIGO NEW YORK~80MG~A~077149~001~A
B~Mar 17, 2006~No~RX~PERRIGO NEW YORK INC
TERCONAZOLE~SUPPOSITORY;VAGINAL~TERCONAZOLE~TARO~80MG~A~077553~001~~Mar 9, 2007~
PALIPERIDONE PALMITATE~SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR~INVEGA SUSTENN
A~JANSSEN PHARMS~39MG/0.25ML (39MG/0.25ML)~N~022264~001~~Jul 31, 2009~No~RX~JANS
A~JANSSEN PHARMS~78MG/0.5ML (78MG/0.5ML)~N~022264~002~~Jul 31, 2009~No~RX~JANSSE
A~JANSSEN PHARMS~117MG/0.75ML (117MG/0.75ML)~N~022264~003~~Jul 31, 2009~Yes~RX~J
ANSSEN PHARMACEUTICALS INC
A~JANSSEN PHARMS~156MG/ML (156MG/ML)~N~022264~004~~Jul 31, 2009~No~RX~JANSSEN PH
ARMACEUTICALS INC
A~JANSSEN PHARMS~234MG/1.5ML (156MG/ML)~N~022264~005~~Jul 31, 2009~No~RX~JANSSEN
PHARMACEUTICALS INC
OLANZAPINE PAMOATE~SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR~ZYPREXA RELPREVV~E
LI LILLY CO~EQ 210MG BASE/VIAL~N~022173~001~~Dec 11, 2009~No~RX~ELI LILLY CO
LI LILLY CO~EQ 300MG BASE/VIAL~N~022173~002~~Dec 11, 2009~No~RX~ELI LILLY CO
LI LILLY CO~EQ 405MG BASE/VIAL~N~022173~003~~Dec 11, 2009~Yes~RX~ELI LILLY CO
CLONIDINE~SUSPENSION, EXTENDED RELEASE;ORAL~CLONIDINE~TRIS PHARMA INC~EQ 0.09MG
BASE/ML~N~022499~001~~Dec 3, 2009~No~DISCN~TRIS PHARMA INC
CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX~SUSPENSION, EXTENDED RELEASE;ORA
L~CODEPREX~UCB INC~EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML~N~021369~001~~Jun 21, 200
4~No~DISCN~UCB INC
DEXTROMETHORPHAN POLISTIREX~SUSPENSION, EXTENDED RELEASE;ORAL~DELSYM~RECKITT BEN
CKISER~EQ 30MG HBR/5ML~N~018658~001~~Oct 8, 1982~Yes~OTC~RECKITT BENCKISER LLC
DEXTROMETHORPHAN POLISTIREX~SUSPENSION, EXTENDED RELEASE;ORAL~DEXTROMETHORPHAN P
OLISTIREX~TRIS PHARMA INC~EQ 30MG HBR/5ML~A~091135~001~~May 25, 2012~No~OTC~TRIS
PHARMA INC
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX~SUSPENSION, EXTENDED RELEASE

;ORAL~HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX~TRIS PHARMA INC~EQ
8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML~A~091632~001~AB~Oct 1, 2010~No~RX~TRIS PH
ARMA INC
;ORAL~HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX~NEOS THERAP INC~EQ 8
MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML~A~091671~001~AB~Jun 29, 2012~No~RX~NEOS TH
ERAPEUTICS INC
CARBINOXAMINE MALEATE~SUSPENSION, EXTENDED RELEASE;ORAL~KARBINAL ER~TRIS PHARMA
INC~4MG/5ML~N~022556~001~~Mar 28, 2013~Yes~RX~TRIS PHARMA INC
CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX~SUSPENSION, EXTENDED RELEASE;ORA
L~PENNTUSS~FISONS~EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML~N~018928~001~~Aug 14, 1985
~No~DISCN~FISONS CORP
PSEUDOEPHEDRINE POLISTIREX~SUSPENSION, EXTENDED RELEASE;ORAL~PSEUDO-12~UCB INC~E
Q 60MG HCL/5ML~N~019401~001~~Jun 19, 1987~No~DISCN~UCB INC
;ORAL~TUSSIONEX PENNKINETIC~UCB INC~EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML~N~
019111~001~AB~Dec 31, 1987~Yes~RX~UCB INC
TETRACYCLINE HYDROCHLORIDE~SUSPENSION/DROPS;OPHTHALMIC~ACHROMYCIN~STORZ~1%~N~050
268~001~~Approved Prior to Jan 1, 1982~No~DISCN~STORZ OPHTHALMICS INC SUB AMERIC
AN CYANAMID CO
LOTEPREDNOL ETABONATE~SUSPENSION/DROPS;OPHTHALMIC~ALREX~BAUSCH AND LOMB~0.2%~N~0
20803~001~~Mar 9, 1998~Yes~RX~BAUSCH AND LOMB INC
BRINZOLAMIDE~SUSPENSION/DROPS;OPHTHALMIC~AZOPT~ALCON PHARMS LTD~1%~N~020816~001~
~Apr 1, 1998~Yes~RX~ALCON PHARMACEUTICALS LTD
BESIFLOXACIN HYDROCHLORIDE~SUSPENSION/DROPS;OPHTHALMIC~BESIVANCE~BAUSCH AND LOMB
~EQ 0.6% BASE~N~022308~001~~May 28, 2009~Yes~RX~BAUSCH AND LOMB INC
LEVOBETAXOLOL HYDROCHLORIDE~SUSPENSION/DROPS;OPHTHALMIC~BETAXON~ALCON PHARMS LTD
~EQ 0.5% BASE~N~021114~001~~Feb 23, 2000~No~DISCN~ALCON PHARMACEUTICALS LTD
BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE~SUSPENSION/DROPS;OPHTHALMIC~B
ETOPTIC PILO~ALCON~EQ 0.25% BASE;1.75%~N~020619~001~~Apr 17, 1997~No~DISCN~ALCON
LABORATORIES INC
BETAXOLOL HYDROCHLORIDE~SUSPENSION/DROPS;OPHTHALMIC~BETOPTIC S~ALCON~EQ 0.25% BA
SE~N~019845~001~~Dec 29, 1989~Yes~RX~ALCON LABORATORIES INC
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE~SUSPENSION/DROPS;OPHTHALMIC~COR-OTICIN~
AKORN~1.5%;EQ 3.5MG BASE/ML~A~060188~001~~Approved Prior to Jan 1, 1982~No~DISCN
~AKORN INC
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OPHTHALMI
C~CORTISPORIN~MONARCH PHARMS~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~N~050169~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~MONARCH PHARMACEUTICALS INC
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OPHTHALMIC
~DEXACIDIN~NOVARTIS~0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~062544~001~~Oct 29,
DEXAMETHASONE~SUSPENSION/DROPS;OPHTHALMIC~DEXAMETHASONE~WATSON LABS~0.1%~A~08917
0~001~~May 9, 1989~No~DISCN~WATSON LABORATORIES INC
~DEXASPORIN~BAUSCH AND LOMB~0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~064135~001~A
T~Sep 13, 1995~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC
~DEXASPORIN~PHARMAFAIR~0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~062428~001~~May 1
PREDNISOLONE ACETATE~SUSPENSION/DROPS;OPHTHALMIC~ECONOPRED~ALCON~0.125%~N~017468
~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALCON LABORATORIES INC
FLUOROMETHOLONE ACETATE~SUSPENSION/DROPS;OPHTHALMIC~FLAREX~ALCON~0.1%~N~019079~0
01~~Feb 11, 1986~Yes~RX~ALCON LABORATORIES INC
FLUOROMETHOLONE~SUSPENSION/DROPS;OPHTHALMIC~FLUOR-OP~NOVARTIS~0.1%~A~070185~001~
~Feb 27, 1986~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
FLUOROMETHOLONE~SUSPENSION/DROPS;OPHTHALMIC~FML~ALLERGAN~0.1%~N~016851~002~~Jul
28, 1982~Yes~RX~ALLERGAN PHARMACEUTICAL
FLUOROMETHOLONE~SUSPENSION/DROPS;OPHTHALMIC~FML FORTE~ALLERGAN~0.25%~N~019216~00
1~~Apr 23, 1986~No~RX~ALLERGAN PHARMACEUTICAL

FLUOROMETHOLONE; SULFACETAMIDE SODIUM~SUSPENSION/DROPS;OPHTHALMIC~FML-S~ALLERGAN
~0.1%;10%~N~019525~001~~Sep 29, 1989~No~DISCN~ALLERGAN PHARMACEUTICAL
NEPAFENAC~SUSPENSION/DROPS;OPHTHALMIC~ILEVRO~ALCON RES LTD~0.3%~N~203491~001~~Oc
t 16, 2012~Yes~RX~ALCON RESEARCH LTD
LEVOCABASTINE HYDROCHLORIDE~SUSPENSION/DROPS;OPHTHALMIC~LIVOSTIN~NOVARTIS~EQ 0.0
5% BASE~N~020219~001~~Nov 10, 1993~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
LOTEPREDNOL ETABONATE~SUSPENSION/DROPS;OPHTHALMIC~LOTEMAX~BAUSCH AND LOMB~0.5%~N
~020583~001~~Mar 9, 1998~Yes~RX~BAUSCH AND LOMB INC
LOTEPREDNOL ETABONATE~SUSPENSION/DROPS;OPHTHALMIC~LOTEMAX~PHARMOS~0.5%~N~020841~
001~~Mar 9, 1998~No~DISCN~PHARMOS CORP
DEXAMETHASONE~SUSPENSION/DROPS;OPHTHALMIC~MAXIDEX~ALCON~0.1%~N~013422~001~~Appro
ved Prior to Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
~MAXITROL~ALCON~0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~062341~001~AT~May 22, 19
84~No~RX~ALCON LABORATORIES INC
~MAXITROL~FALCON PHARMS~0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~N~050023~002~AT~Ap
proved Prior to Jan 1, 1982~Yes~RX~FALCON PHARMACEUTICALS LTD
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~SUSPENSION/DROPS;OPHTHALMIC~METIMYD~S
CHERING~0.5%;10%~N~010210~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING C
ORP SUB SCHERING PLOUGH CORP
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE~SUSPENSION/DROPS;OPHTHALMIC~NEO-CORTEF~
PHARMACIA AND UPJOHN~0.5%;EQ 3.5MG BASE/ML~A~060612~002~~Approved Prior to Jan 1
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE~SUSPENSION/DROPS;OPHTHALMIC~NEO-CORTEF~
PHARMACIA AND UPJOHN~1.5%;EQ 3.5MG BASE/ML~A~060612~001~~Approved Prior to Jan 1
NEOMYCIN SULFATE; PREDNISOLONE ACETATE~SUSPENSION/DROPS;OPHTHALMIC~NEO-DELTA-COR
TEF~PHARMACIA AND UPJOHN~EQ 3.5MG BASE/ML;0.25%~A~061037~001~~Approved Prior to
Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
~NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE~ALCON PHARMS LTD~0.1%;EQ 3.
5MG BASE/ML;10,000 UNITS/ML~A~062721~001~~Nov 17, 1986~No~DISCN~ALCON PHARMACEUT
ICALS LTD
C~NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE~ALCON PHARMS LTD~1%;EQ 3.
5MG BASE/ML;10,000 UNITS/ML~A~062874~001~~May 11, 1988~Yes~RX~ALCON PHARMACEUTIC
ALS LTD
C~NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE~PHARMAFAIR~1%;EQ 3.5MG BAS
E/ML;10,000 UNITS/ML~A~062623~001~~Sep 24, 1985~No~DISCN~PHARMAFAIR INC
NEPAFENAC~SUSPENSION/DROPS;OPHTHALMIC~NEVANAC~ALCON PHARMS LTD~0.1%~N~021862~001
~~Aug 19, 2005~Yes~RX~ALCON PHARMACEUTICALS LTD
PREDNISOLONE ACETATE~SUSPENSION/DROPS;OPHTHALMIC~OMNIPRED~ALCON~1%~N~017469~001~
AB~Approved Prior to Jan 1, 1982~No~RX~ALCON LABORATORIES INC
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE~SUSPENSION/DROPS;OPH
THALMIC~POLY-PRED~ALLERGAN~EQ 0.35% BASE;10,000 UNITS/ML;0.5%~N~050081~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTICAL
PREDNISOLONE ACETATE~SUSPENSION/DROPS;OPHTHALMIC~PRED FORTE~ALLERGAN~1%~N~017011
~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~ALLERGAN PHARMACEUTICAL
PREDNISOLONE ACETATE~SUSPENSION/DROPS;OPHTHALMIC~PRED MILD~ALLERGAN~0.12%~N~0171
00~001~~Approved Prior to Jan 1, 1982~Yes~RX~ALLERGAN PHARMACEUTICAL
GENTAMICIN SULFATE; PREDNISOLONE ACETATE~SUSPENSION/DROPS;OPHTHALMIC~PRED-G~ALLE
RGAN~EQ 0.3% BASE;1%~N~050586~001~~Jun 10, 1988~Yes~RX~ALLERGAN PHARMACEUTICAL
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~SUSPENSION/DROPS;OPHTHALMIC~PREDAMIDE
~AKORN~0.5%;10%~A~088059~001~~Jul 29, 1983~No~DISCN~AKORN INC
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~SUSPENSION/DROPS;OPHTHALMIC~PREDSULFA
IR~PHARMAFAIR~0.5%;10%~A~088007~001~~Apr 19, 1983~No~DISCN~PHARMAFAIR INC
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~SUSPENSION/DROPS;OPHTHALMIC~PREDSULFA
IR II~PHARMAFAIR~0.2%;10%~A~088837~001~~Dec 24, 1985~No~DISCN~PHARMAFAIR INC

BRIMONIDINE TARTRATE; BRINZOLAMIDE~SUSPENSION/DROPS;OPHTHALMIC~SIMBRINZA~ALCON R
ES LTD~0.2%;1%~N~204251~001~~Apr 19, 2013~Yes~RX~ALCON RESEARCH LTD
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~SUSPENSION/DROPS;OPHTHALMIC~SULPHRIN~
BAUSCH AND LOMB~0.5%;10%~A~088089~001~~Dec 28, 1982~No~DISCN~BAUSCH AND LOMB INC
DEXAMETHASONE; TOBRAMYCIN~SUSPENSION/DROPS;OPHTHALMIC~TOBRADEX~ALCON~0.1%;0.3%~N
~050592~001~AB~Aug 18, 1988~Yes~RX~ALCON LABORATORIES INC
DEXAMETHASONE; TOBRAMYCIN~SUSPENSION/DROPS;OPHTHALMIC~TOBRADEX ST~ALCON PHARMS L
TD~0.05%;0.3%~N~050818~001~~Feb 13, 2009~Yes~RX~ALCON PHARMACEUTICALS LTD
DEXAMETHASONE; TOBRAMYCIN~SUSPENSION/DROPS;OPHTHALMIC~TOBRAMYCIN AND DEXAMETHASO
NE~BAUSCH AND LOMB~0.1%;0.3%~A~064134~001~AB~Oct 27, 1999~No~RX~BAUSCH AND LOMB
PHARMACEUTICALS INC
FLUOROMETHOLONE ACETATE; TOBRAMYCIN~SUSPENSION/DROPS;OPHTHALMIC~TOBRASONE~ALCON~
0.1%;0.3%~N~050628~001~~Jul 21, 1989~No~DISCN~ALCON LABORATORIES INC
RIMEXOLONE~SUSPENSION/DROPS;OPHTHALMIC~VEXOL~ALCON~1%~N~020474~001~~Dec 30, 1994
~Yes~RX~ALCON LABORATORIES INC
LOTEPREDNOL ETABONATE; TOBRAMYCIN~SUSPENSION/DROPS;OPHTHALMIC~ZYLET~BAUSCH AND L
OMB~0.5%;0.3%~N~050804~001~~Dec 14, 2004~Yes~RX~BAUSCH AND LOMB INC
IBUPROFEN~SUSPENSION/DROPS;ORAL~CHILDREN'S MOTRIN~MCNEIL CONS~40MG/ML~N~020603~0
01~~Jun 10, 1996~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
IBUPROFEN~SUSPENSION/DROPS;ORAL~IBUPROFEN~PERRIGO~40MG/ML~A~075217~001~~Dec 16,
1998~No~OTC~PERRIGO CO
IBUPROFEN~SUSPENSION/DROPS;ORAL~IBUPROFEN~TRIS PHARMA INC~40MG/ML~A~079058~001~~
Aug 31, 2009~No~OTC~TRIS PHARMA INC
ERYTHROMYCIN ESTOLATE~SUSPENSION/DROPS;ORAL~ILOSONE~LILLY~EQ 100MG BASE/ML~A~061
IBUPROFEN~SUSPENSION/DROPS;ORAL~MOTRIN~MCNEIL~40MG/ML~N~020476~001~~May 25, 1995
~No~DISCN~MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION/DROPS;ORAL~PEDIAMYCIN~ROSS LABS~EQ 100MG
BASE/2.5ML~A~062305~002~~Approved Prior to Jan 1, 1982~No~DISCN~ROSS LABORATORIE
S DIV ABBOTT LABORATORIES INC
IBUPROFEN~SUSPENSION/DROPS;ORAL~PEDIATRIC ADVIL~PFIZER~100MG/2.5ML~N~020812~001~
~Jan 30, 1998~Yes~OTC~PFIZER INC
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE~SUSPENSION/DROPS;OTIC~CIPRO HC~ALCON
PHARMS LTD~EQ 0.2% BASE;1%~N~020805~001~~Feb 10, 1998~Yes~RX~ALCON PHARMACEUTIC
ALS LTD
CIPROFLOXACIN; DEXAMETHASONE~SUSPENSION/DROPS;OTIC~CIPRODEX~ALCON PHARMS LTD~0.3
%;0.1%~N~021537~001~~Jul 18, 2003~Yes~RX~ALCON PHARMACEUTICALS LTD
COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE~S
USPENSION/DROPS;OTIC~COLY-MYCIN S~PAR STERILE PRODUCTS~EQ 3MG BASE/ML;10MG/ML;EQ
3.3MG BASE/ML;0.5MG/ML~N~050356~001~~Approved Prior to Jan 1, 1982~Yes~RX~PAR S
TERILE PRODUCTS LLC
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OTIC~CORT
ISPORIN~CITRON PHARMA LLC~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~060613~001~AT~Ap
proved Prior to Jan 1, 1982~Yes~RX~CITRON PHARMA LLC
ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE~SUSPENSION/DROPS;OTIC~NEO
-CORT-DOME~BAYER PHARMS~2%;1%;EQ 0.35% BASE~N~050238~001~~Approved Prior to Jan
1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OTIC~NEOM
YCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE~ALCON PHARMS LTD~1%;EQ 3.5MG BA
SE/ML;10,000 UNITS/ML~A~062488~001~AT~Nov 6, 1985~No~RX~ALCON PHARMACEUTICALS LT
D
YCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE~LUITPOLD~1%;EQ 3.5MG BASE/ML;10
,000 UNITS/ML~A~065219~001~AT~May 1, 2006~No~RX~LUITPOLD PHARMACEUTICALS INC
YCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE~PHARMAFAIR~1%;EQ 3.5MG BASE/M
L;10,000 UNITS/ML~A~062617~001~~Sep 18, 1985~No~DISCN~PHARMAFAIR INC
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OTIC~OTIC
AIR~BAUSCH AND LOMB~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~064065~001~AT~Aug 28,
1996~No~RX~BAUSCH AND LOMB PHARMACEUTICALS INC

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OTIC~OTIC
AIR~PHARMAFAIR~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~062399~001~~Nov 18, 1982~No
~DISCN~PHARMAFAIR INC
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OTIC~OTOB
IONE~SCHERING~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~061816~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OTIC~OTOC
ORT~ACTAVIS LABS FL INC~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~062521~001~~Jul 11
, 1985~No~DISCN~ACTAVIS LABORATORIES FL INC
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE~SUSPENSION/DROPS;OTIC~PEDI
OTIC~MONARCH PHARMS~1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML~A~062822~001~AT~Sep 29,
1987~No~RX~MONARCH PHARMACEUTICALS INC
FINAFLOXACIN~SUSPENSION/DROPS;OTIC~XTORO~ALCON RES LTD~0.3%~N~206307~001~~Dec 17
, 2014~Yes~RX~ALCON RESEARCH LTD
CARBIDOPA; LEVODOPA~SUSPENSION;ENTERAL~DUOPA~ABBVIE INC~4.63MG/ML;20MG/ML~N~2039
52~001~~Jan 9, 2015~Yes~RX~ABBVIE INC
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~APOTEX INC~0.25MG/2ML~A~078202~001~~
Mar 30, 2009~No~DISCN~APOTEX INC
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~APOTEX INC~0.5MG/2ML~A~078202~002~~M
ar 30, 2009~No~DISCN~APOTEX INC
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~SANDOZ~0.25MG/2ML~A~201966~003~AN~Se
p 27, 2013~No~RX~SANDOZ INC
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~SANDOZ~0.5MG/2ML~A~201966~002~AN~Sep
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~SANDOZ~1MG/2ML~A~201966~001~AN~Sep 2
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~TEVA PHARMS~0.25MG/2ML~A~077519~001~
AN~Nov 18, 2008~No~RX~TEVA PHARMACEUTICALS USA
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~TEVA PHARMS~0.5MG/2ML~A~077519~002~A
N~Nov 18, 2008~No~RX~TEVA PHARMACEUTICALS USA
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~WATSON LABS INC~0.25MG/2ML~A~078404~
001~AN~Jul 31, 2012~No~RX~WATSON LABORATORIES INC
BUDESONIDE~SUSPENSION;INHALATION~BUDESONIDE~WATSON LABS INC~0.5MG/2ML~A~078404~0
02~AN~Jul 31, 2012~No~RX~WATSON LABORATORIES INC
BUDESONIDE~SUSPENSION;INHALATION~PULMICORT RESPULES~ASTRAZENECA PHARMS~0.25MG/2M
L~N~020929~001~AN~Aug 8, 2000~No~RX~ASTRAZENECA PHARMACEUTICALS LP
BUDESONIDE~SUSPENSION;INHALATION~PULMICORT RESPULES~ASTRAZENECA PHARMS~0.5MG/2ML
~N~020929~002~AN~Aug 8, 2000~No~RX~ASTRAZENECA PHARMACEUTICALS LP
BUDESONIDE~SUSPENSION;INHALATION~PULMICORT RESPULES~ASTRAZENECA PHARMS~1MG/2ML~N
~020929~003~AN~Aug 8, 2000~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
PORACTANT ALFA~SUSPENSION;INTRATRACHEAL~CUROSURF~CHIESI USA INC~80MG/ML~N~020744
~001~~Nov 18, 1999~Yes~RX~CHIESI USA INC
PROPYLIODONE~SUSPENSION;INTRATRACHEAL~DIONOSIL AQUEOUS~GLAXOSMITHKLINE~50%~N~009
PROPYLIODONE~SUSPENSION;INTRATRACHEAL~DIONOSIL OILY~GLAXOSMITHKLINE~60%~N~009309
CALFACTANT~SUSPENSION;INTRATRACHEAL~INFASURF PRESERVATIVE FREE~ONY~35MG/ML~N~020
521~001~~Jul 1, 1998~Yes~RX~ONY INC
LUCINACTANT~SUSPENSION;INTRATRACHEAL~SURFAXIN~DISCOVERY LABS~8.5ML~N~021746~001~
~Mar 6, 2012~Yes~RX~DISCOVERY LABORATORIES INC
BERACTANT~SUSPENSION;INTRATRACHEAL~SURVANTA~ABBVIE~25MG/ML~N~020032~001~~Jul 1,
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~SUSPENSION;OPHTHALMIC~BLEPHAMIDE~ALLE
RGAN~0.2%;10%~N~012813~002~~Approved Prior to Jan 1, 1982~Yes~RX~ALLERGAN PHARMA
CEUTICAL
MEDRYSONE~SUSPENSION;OPHTHALMIC~HMS~ALLERGAN~1%~N~016624~003~~Approved Prior to
Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTICAL
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM~SUSPENSION;OPHTHALMIC~ISOPTO CETAPRED
~ALCON~0.25%;10%~A~087547~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALCON LABO
RATORIES INC
NATAMYCIN~SUSPENSION;OPHTHALMIC~NATACYN~ALCON~5%~N~050514~001~~Approved Prior to
Jan 1, 1982~Yes~RX~ALCON LABORATORIES INC
HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE~SUSPENSION;OPHTHALMIC~TERR
A-CORTRIL~PFIZER~1.5%;EQ 5MG BASE/ML~A~061016~001~~Approved Prior to Jan 1, 1982
~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
TETRACYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~ACHROMYCIN V~LEDERLE~125MG/5ML~N~0502
CYANAMID CO
ACYCLOVIR~SUSPENSION;ORAL~ACYCLOVIR~ACTAVIS MID ATLANTIC~200MG/5ML~A~074738~001~
AB~Apr 28, 1997~No~RX~ACTAVIS MID ATLANTIC LLC
ACYCLOVIR~SUSPENSION;ORAL~ACYCLOVIR~HI TECH PHARMA~200MG/5ML~A~077026~001~AB~Jun
METHYLDOPA~SUSPENSION;ORAL~ALDOMET~MERCK~250MG/5ML~N~018389~001~~Approved Prior
FEXOFENADINE HYDROCHLORIDE~SUSPENSION;ORAL~ALLEGRA~SANOFI AVENTIS US~30MG/5ML~N~
021963~001~AB~Oct 16, 2006~Yes~RX~SANOFI AVENTIS US LLC
AMOXICILLIN; CLAVULANATE POTASSIUM~SUSPENSION;ORAL~AMOXICILLIN AND CLAVULANATE P
OTASSIUM~AUROBINDO PHARMA LTD~200MG/5ML;EQ 28.5MG BASE/5ML~A~201090~001~AB~Dec 2
0, 2011~No~RX~AUROBINDO PHARMA LTD
OTASSIUM~AUROBINDO PHARMA LTD~400MG/5ML;EQ 57MG BASE/5ML~A~201090~002~AB~Dec 20,
OTASSIUM~AUROBINDO PHARMA LTD~600MG/5ML;EQ 42.9MG BASE/5ML~A~201091~001~AB~Dec 2
ATOVAQUONE~SUSPENSION;ORAL~ATOVAQUONE~AMNEAL PHARMS~750MG/5ML~A~202960~001~AB~Ma
r 18, 2014~No~RX~AMNEAL PHARMACEUTICALS
SULFASALAZINE~SUSPENSION;ORAL~AZULFIDINE~PHARMACIA AND UPJOHN~250MG/5ML~A~086983
~001~~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
SULFASALAZINE~SUSPENSION;ORAL~AZULFIDINE~PHARMACIA AND UPJOHN~250MG/5ML~N~018605
~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~BACTRIM~MUTUAL PHARM~200MG/5ML;40
MG/5ML~N~017560~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICA
L CO INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~BACTRIM PEDIATRIC~MUTUAL PHARM~20
0MG/5ML;40MG/5ML~N~017560~002~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHA
RMACEUTICAL CO INC
RUFINAMIDE~SUSPENSION;ORAL~BANZEL~EISAI INC~40MG/ML~N~201367~001~~Mar 3, 2011~Ye
s~RX~EISAI INC
PENICILLIN G BENZATHINE~SUSPENSION;ORAL~BICILLIN~WYETH AYERST~300,000 UNITS/5ML~
N~050126~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
ACETAMINOPHEN; CODEINE PHOSPHATE~SUSPENSION;ORAL~CAPITAL AND CODEINE~ACTAVIS MID
ATLANTIC~120MG/5ML;12MG/5ML~A~085883~001~~Approved Prior to Jan 1, 1982~No~DISC
N~ACTAVIS MID ATLANTIC LLC
ACETAMINOPHEN; CODEINE PHOSPHATE~SUSPENSION;ORAL~CAPITAL AND CODEINE~VALEANT PHA
RMS LLC~120MG/5ML;12MG/5ML~A~086024~001~~Approved Prior to Jan 1, 1982~Yes~RX~VA
LEANT PHARMACEUTICALS NORTH AMERICA LLC
SUCRALFATE~SUSPENSION;ORAL~CARAFATE~FOREST LABS INC~1GM/10ML~N~019183~001~~Dec 1
CARBAMAZEPINE~SUSPENSION;ORAL~CARBAMAZEPINE~TARO~100MG/5ML~A~075875~001~~Dec 21,
2000~No~DISCN~TARO PHARMACEUTICAL INDUSTRIES LTD
CARBAMAZEPINE~SUSPENSION;ORAL~CARBAMAZEPINE~WOCKHARDT~100MG/5ML~A~075714~001~AB~
Jun 5, 2002~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
MYCOPHENOLATE MOFETIL~SUSPENSION;ORAL~CELLCEPT~ROCHE PALO~200MG/ML~N~050759~001~
AB~Oct 1, 1998~Yes~RX~ROCHE PALO ALTO LLC
IBUPROFEN~SUSPENSION;ORAL~CHILDREN'S ADVIL~PFIZER~100MG/5ML~N~020589~001~~Jun 27
, 1996~No~OTC~PFIZER INC
IBUPROFEN~SUSPENSION;ORAL~CHILDREN'S ADVIL~WYETH CONS~100MG/5ML~N~019833~002~~Se
p 19, 1989~No~DISCN~WYETH CONSUMER HEALTHCARE
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~SUSPENSION;OR

AL~CHILDREN'S ADVIL ALLERGY SINUS~PFIZER~1MG/5ML;100MG/5ML;15MG/5ML~N~021587~001
~~Feb 24, 2004~Yes~OTC~PFIZER INC
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~SUSPENSION;ORAL~CHILDREN'S ADVIL COLD~P
FIZER~100MG/5ML;15MG/5ML~N~021373~001~~Apr 18, 2002~No~OTC~PFIZER INC
IBUPROFEN~SUSPENSION;ORAL~CHILDREN'S ADVIL-FLAVORED~PFIZER~100MG/5ML~N~020589~00
2~~Nov 7, 1997~No~OTC~PFIZER INC
FEXOFENADINE HYDROCHLORIDE~SUSPENSION;ORAL~CHILDREN'S ALLEGRA ALLERGY~SANOFI AVE
NTIS US~30MG/5ML~N~201373~001~~Jan 24, 2011~Yes~OTC~SANOFI AVENTIS US LLC
FEXOFENADINE HYDROCHLORIDE~SUSPENSION;ORAL~CHILDREN'S ALLEGRA HIVES~SANOFI AVENT
IS US~30MG/5ML~N~201373~002~~Jan 24, 2011~Yes~OTC~SANOFI AVENTIS US LLC
IBUPROFEN~SUSPENSION;ORAL~CHILDREN'S ELIXSURE~MOBERG PHARMA NORTH~100MG/5ML~N~02
1604~001~~Jan 7, 2004~No~OTC~MOBERG PHARMA NORTH AMERICA LLC
FEXOFENADINE HYDROCHLORIDE~SUSPENSION;ORAL~CHILDREN'S FEXOFENADINE HYDROCHLORIDE
ALLERGY~ACTAVIS MID ATLANTIC~30MG/5ML~A~203330~001~~Nov 18, 2014~No~OTC~ACTAVIS
MID ATLANTIC LLC
FEXOFENADINE HYDROCHLORIDE~SUSPENSION;ORAL~CHILDREN'S FEXOFENADINE HYDROCHLORIDE
HIVES~ACTAVIS MID ATLANTIC~30MG/5ML~A~203330~002~~Nov 18, 2014~No~OTC~ACTAVIS M
ID ATLANTIC LLC
IBUPROFEN~SUSPENSION;ORAL~CHILDREN'S IBUPROFEN~PERRIGO~100MG/5ML~A~074937~001~~D
ec 22, 1998~No~OTC~L PERRIGO CO
IBUPROFEN~SUSPENSION;ORAL~CHILDREN'S MOTRIN~MCNEIL~100MG/5ML~N~020516~001~~Jun 1
6, 1995~Yes~OTC~MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~SUSPENSION;ORAL~CHILDREN'S MOTRIN COLD~
MCNEIL CONS~100MG/5ML;15MG/5ML~N~021128~001~~Aug 1, 2000~Yes~OTC~MCNEIL CONSUMER
HEALTHCARE
CHLORAMPHENICOL PALMITATE~SUSPENSION;ORAL~CHLOROMYCETIN PALMITATE~PARKE DAVIS~EQ
150MG BASE/5ML~A~062301~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS
PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
CHLORAMPHENICOL PALMITATE~SUSPENSION;ORAL~CHLOROMYCETIN PALMITATE~PARKE DAVIS~EQ
150MG BASE/5ML~N~050152~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS
PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
COLISTIN SULFATE~SUSPENSION;ORAL~COLY-MYCIN S~PARKE DAVIS~EQ 25MG BASE/5ML~N~050
355~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT C
O
HYDROCORTISONE CYPIONATE~SUSPENSION;ORAL~CORTEF~PHARMACIA AND UPJOHN~EQ 10MG BAS
E/5ML~N~009900~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN
CO
PROPOXYPHENE NAPSYLATE~SUSPENSION;ORAL~DARVON-N~AAIPHARMA LLC~50MG/5ML~N~016861~
001~~Approved Prior to Jan 1, 1982~No~DISCN~AAIPHARMA LLC
PHENYTOIN~SUSPENSION;ORAL~DILANTIN-125~PARKE DAVIS~125MG/5ML~N~008762~001~AB~App
roved Prior to Jan 1, 1982~Yes~RX~PARKE DAVIS DIV WARNER LAMBERT CO
PHENYTOIN~SUSPENSION;ORAL~DILANTIN-30~PARKE DAVIS~30MG/5ML~N~008762~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
CHLOROTHIAZIDE~SUSPENSION;ORAL~DIURIL~SALIX PHARMS~250MG/5ML~N~011870~001~~Appro
ved Prior to Jan 1, 1982~Yes~RX~SALIX PHARMACEUTICALS INC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~E-MYCIN E~PHARMACIA AND UPJOHN~EQ 20
0MG BASE/5ML~A~062198~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND
UPJOHN CO
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~E-MYCIN E~PHARMACIA AND UPJOHN~EQ 40
0MG BASE/5ML~A~062198~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND
UPJOHN CO
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~E.E.S. 200~ARBOR PHARMS LLC~EQ 200MG
BASE/5ML~A~061639~001~AB~Approved Prior to Jan 1, 1982~No~RX~ARBOR PHARMACEUTIC
ALS LLC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~E.E.S. 400~ARBOR PHARMS LLC~EQ 400MG
BASE/5ML~A~061639~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~ARBOR PHARMACEUTI
CALS LLC
THEOPHYLLINE~SUSPENSION;ORAL~ELIXICON~FOREST LABS~100MG/5ML~A~085502~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~FOREST LABORATORIES INC
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ERYTHROMYCIN ESTOLATE~ALPHARMA US PHARMS~E

Q 125MG BASE/5ML~A~062353~001~~Nov 18, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS
DIVISION
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ERYTHROMYCIN ESTOLATE~ALPHARMA US PHARMS~E
Q 250MG BASE/5ML~A~062409~001~~Dec 16, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS
DIVISION
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ERYTHROMYCIN ESTOLATE~BARR~EQ 125MG BASE/5
ML~A~062169~001~~Oct 17, 1990~No~DISCN~BARR LABORATORIES INC
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ERYTHROMYCIN ESTOLATE~BARR~EQ 250MG BASE/5
ML~A~062169~002~~Oct 17, 1990~No~DISCN~BARR LABORATORIES INC
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ERYTHROMYCIN ESTOLATE~LIFE LABS~EQ 250MG B
ASE/5ML~A~062362~001~~Dec 17, 1982~No~DISCN~LIFE LABORATORIES INC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~ALPHARMA
US PHARMS~EQ 200MG BASE/5ML~A~062200~001~~Approved Prior to Jan 1, 1982~No~DISC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~ALPHARMA
US PHARMS~EQ 400MG BASE/5ML~A~062200~002~~Approved Prior to Jan 1, 1982~No~DISC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~DISTA~EQ
200MG BASE/5ML~A~062177~001~~Approved Prior to Jan 1, 1982~No~DISCN~DISTA PRODU
CTS CO DIV ELI LILLY AND CO
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~DISTA~EQ
400MG BASE/5ML~A~062177~002~~Approved Prior to Jan 1, 1982~No~DISCN~DISTA PRODU
CTS CO DIV ELI LILLY AND CO
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~NASKA~EQ
400MG BASE/5ML~A~062674~001~~Mar 10, 1987~No~DISCN~NASKA PHARMACAL CO INC DIV R
UGBY DARBY GROUP COSMETICS
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~PARKE DA
VIS~EQ 200MG BASE/5ML~A~062231~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE
DAVIS DIV WARNER LAMBERT CO
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~PARKE DA
VIS~EQ 400MG BASE/5ML~A~062231~002~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE
DAVIS DIV WARNER LAMBERT CO
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~PHARMAFA
IR~EQ 200MG BASE/5ML~A~062559~001~~Mar 15, 1985~No~DISCN~PHARMAFAIR INC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~PHARMAFA
IR~EQ 400MG BASE/5ML~A~062558~001~~Mar 15, 1985~No~DISCN~PHARMAFAIR INC
FAMOTIDINE~SUSPENSION;ORAL~FAMOTIDINE~NOVEL LABS INC~40MG/5ML~A~201695~001~AB~De
c 17, 2012~No~RX~NOVEL LABORATORIES INC
FELBAMATE~SUSPENSION;ORAL~FELBAMATE~AMNEAL PHARMS~600MG/5ML~A~202385~001~AB~Dec
FELBAMATE~SUSPENSION;ORAL~FELBATOL~MEDA PHARMS~600MG/5ML~N~020189~003~AB~Jul 29,
1993~Yes~RX~MEDA PHARMACEUTICALS INC
FEXOFENADINE HYDROCHLORIDE~SUSPENSION;ORAL~FEXOFENADINE HYDROCHLORIDE~ACTAVIS MI
D ATLANTIC~30MG/5ML~A~201311~001~AB~Jul 25, 2012~No~RX~ACTAVIS MID ATLANTIC LLC
PREDNISOLONE ACETATE~SUSPENSION;ORAL~FLO-PRED~TARO~EQ 5MG BASE/5ML~N~022067~001~
~Jan 17, 2008~No~DISCN~TARO PHARMACEUTICALS USA INC
PREDNISOLONE ACETATE~SUSPENSION;ORAL~FLO-PRED~TARO~EQ 15MG BASE/5ML~N~022067~002
~~Jan 17, 2008~Yes~RX~TARO PHARMACEUTICALS USA INC
AMPHOTERICIN B~SUSPENSION;ORAL~FUNGIZONE~BRISTOL MYERS SQUIBB~100MG/ML~N~050341~
003~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
NITROFURANTOIN~SUSPENSION;ORAL~FURADANTIN~SHIONOGI INC~25MG/5ML~N~009175~001~AB~
Approved Prior to Jan 1, 1982~Yes~RX~SHIONOGI INC
FURAZOLIDONE~SUSPENSION;ORAL~FUROXONE~SHIRE~50MG/15ML~N~011323~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
SULFAMETHOXAZOLE~SUSPENSION;ORAL~GANTANOL~ROCHE~500MG/5ML~N~013664~002~~Approved
SULFISOXAZOLE ACETYL~SUSPENSION;ORAL~GANTRISIN PEDIATRIC~ROCHE~EQ 500MG BASE/5ML
~N~009182~004~~Approved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
FERUMOXSIL~SUSPENSION;ORAL~GASTROMARK~AMAG PHARMS INC~EQ 0.175MG IRON/ML~N~02041
0~001~~Dec 6, 1996~No~DISCN~AMAG PHARMACEUTICALS INC

ZIPRASIDONE HYDROCHLORIDE~SUSPENSION;ORAL~GEODON~PFIZER INC~EQ 10MG BASE/ML~N~02
1483~001~~Mar 29, 2006~Yes~RX~PFIZER INC
GRISEOFULVIN, MICROCRYSTALLINE~SUSPENSION;ORAL~GRIFULVIN V~JOHNSON AND JOHNSON~1
25MG/5ML~N~050448~001~~Approved Prior to Jan 1, 1982~No~DISCN~JOHNSON AND JOHNSO
N CONSUMER COMPANIES INC
GRISEOFULVIN, MICROSIZE~SUSPENSION;ORAL~GRIFULVIN V~VALEANT LUXEMBOURG~125MG/5ML
~A~062483~001~~Jan 26, 1984~No~DISCN~VALEANT PHARMACEUTICALS LUXEMBOURG SARL
GRISEOFULVIN, MICROSIZE~SUSPENSION;ORAL~GRISEOFULVIN~ACTAVIS MID ATLANTIC~125MG/
5ML~A~065394~001~AB~Jul 6, 2007~Yes~RX~ACTAVIS MID ATLANTIC LLC
GRISEOFULVIN, MICROSIZE~SUSPENSION;ORAL~GRISEOFULVIN~IVAX SUB TEVA PHARMS~125MG/
5ML~A~065354~001~AB~Sep 10, 2007~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMAC
EUTICALS USA
GRISEOFULVIN, MICROSIZE~SUSPENSION;ORAL~GRISEOFULVIN~PERRIGO CO TENNESSEE~125MG/
5ML~A~065200~001~AB~Mar 2, 2005~No~RX~PERRIGO CO TENNESSEE INC
GRISEOFULVIN, MICROSIZE~SUSPENSION;ORAL~GRISEOFULVIN~VINTAGE PHARMS~125MG/5ML~A~
065438~001~AB~Oct 8, 2010~No~RX~VINTAGE PHARMACEUTICALS
IBUPROFEN~SUSPENSION;ORAL~IBU~ABBOTT~100MG/5ML~N~019784~001~~Dec 18, 1989~No~DIS
CN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
IBUPROFEN~SUSPENSION;ORAL~IBUPROFEN~ACTAVIS MID ATLANTIC~100MG/5ML~A~074916~001~
~Apr 30, 1999~No~OTC~ACTAVIS MID ATLANTIC LLC
IBUPROFEN~SUSPENSION;ORAL~IBUPROFEN~ACTAVIS MID ATLANTIC~100MG/5ML~A~074978~001~
AB~Mar 25, 1998~Yes~RX~ACTAVIS MID ATLANTIC LLC
IBUPROFEN~SUSPENSION;ORAL~IBUPROFEN~AMNEAL PHARMS~100MG/5ML~A~200457~001~~Aug 18
, 2011~No~OTC~AMNEAL PHARMACEUTICALS
IBUPROFEN~SUSPENSION;ORAL~IBUPROFEN~PERRIGO R AND D~100MG/5ML~A~076925~001~AB~Se
p 23, 2004~No~RX~PERRIGO R AND D CO
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~SUSPENSION;ORAL~IBUPROFEN AND PSEUDOEPH
EDRINE HYDROCHLORIDE~PERRIGO~100MG/5ML;15MG/5ML~A~076478~001~~Nov 5, 2003~No~OTC
~L PERRIGO CO
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ILOSONE~LILLY~EQ 125MG BASE/5ML~A~061894~0
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ILOSONE~LILLY~EQ 125MG BASE/5ML~N~050010~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~LILLY RESEARCH LABORATORIES DIV ELI L
ILLY AND CO
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ILOSONE~LILLY~EQ 250MG BASE/5ML~A~061894~0
ERYTHROMYCIN ESTOLATE~SUSPENSION;ORAL~ILOSONE~LILLY~EQ 250MG BASE/5ML~N~050010~0
02~~Approved Prior to Jan 1, 1982~No~DISCN~LILLY RESEARCH LABORATORIES DIV ELI L
ILLY AND CO
ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL~SUSPENSION;ORAL~ILOSONE SULFA~LILLY~
EQ 125MG BASE/5ML;EQ 600MG BASE/5ML~N~050599~001~~Sep 29, 1989~No~DISCN~ELI LILL
Y AND CO
LOPERAMIDE HYDROCHLORIDE~SUSPENSION;ORAL~IMODIUM A-D~MCNEIL CONS~1MG/7.5ML~N~019
487~002~~Jul 8, 2004~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
PROPRANOLOL HYDROCHLORIDE~SUSPENSION;ORAL~INDERAL~WYETH AYERST~10MG/ML~N~019536~
001~~Dec 12, 1986~No~DISCN~WYETH AYERST LABORATORIES
INDOMETHACIN~SUSPENSION;ORAL~INDOCIN~IROKO PHARMS~25MG/5ML~N~018332~001~~Oct 10,
INDOMETHACIN~SUSPENSION;ORAL~INDOMETHACIN~CYCLE PHARMS LTD~25MG/5ML~A~071412~001
~~Mar 18, 1987~No~DISCN~CYCLE PHARMACEUTICALS LTD
TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)~SUSPENSION;ORAL~
LANTRISUL~LANNETT~167MG/5ML;167MG/5ML;167MG/5ML~A~080123~002~~Approved Prior to
Jan 1, 1982~No~DISCN~LANNETT CO INC
FOSAMPRENAVIR CALCIUM~SUSPENSION;ORAL~LEXIVA~VIIV HLTHCARE~EQ 50MG BASE/ML~N~022
116~001~~Jun 14, 2007~Yes~RX~VIIV HEALTHCARE CO
LOPERAMIDE HYDROCHLORIDE~SUSPENSION;ORAL~LOPERAMIDE HYDROCHLORIDE~PERRIGO R AND
D~1MG/7.5ML~A~091292~001~~May 20, 2011~No~OTC~PERRIGO R AND D CO
LORATADINE~SUSPENSION;ORAL~LORATADINE~TARO~1MG/ML~N~021734~001~~Oct 4, 2005~Yes~
OTC~TARO PHARMACEUTICALS USA INC
MEGESTROL ACETATE~SUSPENSION;ORAL~MEGACE~BRISTOL MYERS SQUIBB~40MG/ML~N~020264~0

01~AB~Sep 10, 1993~Yes~RX~BRISTOL MYERS SQUIBB
MEGESTROL ACETATE~SUSPENSION;ORAL~MEGACE ES~PAR PHARM~125MG/ML~N~021778~001~AB~J
ul 5, 2005~Yes~RX~PAR PHARMACEUTICAL INC
MEGESTROL ACETATE~SUSPENSION;ORAL~MEGESTROL ACETATE~APOTEX INC~40MG/ML~A~077404~
001~~Feb 16, 2006~No~DISCN~APOTEX INC
MEGESTROL ACETATE~SUSPENSION;ORAL~MEGESTROL ACETATE~PAR PHARM~40MG/ML~A~075671~0
01~AB~Jul 25, 2001~No~RX~PAR PHARMACEUTICAL INC
MEGESTROL ACETATE~SUSPENSION;ORAL~MEGESTROL ACETATE~ROXANE~40MG/ML~A~075997~001~
AB~Feb 15, 2002~No~RX~ROXANE LABORATORIES INC
MEGESTROL ACETATE~SUSPENSION;ORAL~MEGESTROL ACETATE~TEVA PHARMS~40MG/ML~A~075681
~001~AB~May 5, 2003~No~RX~TEVA PHARMACEUTICALS USA
MEGESTROL ACETATE~SUSPENSION;ORAL~MEGESTROL ACETATE~TWI PHARMS INC~125MG/ML~A~20
3139~001~AB~Aug 27, 2014~No~RX~TWI PHARMACEUTICALS INC
MEGESTROL ACETATE~SUSPENSION;ORAL~MEGESTROL ACETATE~WOCKHARDT~40MG/ML~A~076721~0
01~AB~Nov 1, 2004~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
THIORIDAZINE~SUSPENSION;ORAL~MELLARIL-S~NOVARTIS~EQ 25MG HCL/5ML~N~017923~001~~A
THIORIDAZINE~SUSPENSION;ORAL~MELLARIL-S~NOVARTIS~EQ 100MG HCL/5ML~N~017923~002~~
ATOVAQUONE~SUSPENSION;ORAL~MEPRON~GLAXOSMITHKLINE LLC~750MG/5ML~N~020500~001~AB~
Feb 8, 1995~Yes~RX~GLAXOSMITHKLINE LLC
MINOCYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~MINOCIN~PRECISION DERMAT~EQ 50MG BASE/
5ML~N~050445~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRECISION DERMATOLOGY I
NC
THIABENDAZOLE~SUSPENSION;ORAL~MINTEZOL~MERCK SHARP DOHME~500MG/5ML~N~016097~001~
~Approved Prior to Jan 1, 1982~No~DISCN~MERCK SHARP AND DOHME CORP
MELOXICAM~SUSPENSION;ORAL~MOBIC~BOEHRINGER INGELHEIM~7.5MG/5ML~N~021530~001~~Jun
IBUPROFEN~SUSPENSION;ORAL~MOTRIN~MCNEIL CONSUMER~100MG/5ML~N~019842~001~~Sep 19,
1989~No~DISCN~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
MYCOPHENOLATE MOFETIL~SUSPENSION;ORAL~MYCOPHENOLATE MOFETIL~ALKEM LABS LTD~200MG
/ML~A~203005~001~AB~Nov 14, 2014~No~RX~ALKEM LABORATORIES LTD
NYSTATIN~SUSPENSION;ORAL~MYCOSTATIN~DELCOR ASSET CORP~100,000 UNITS/ML~A~061533~
PRIMIDONE~SUSPENSION;ORAL~MYSOLINE~NURO PHARMA~250MG/5ML~N~010401~001~~Approved
Prior to Jan 1, 1982~No~DISCN~NURO PHARMA LLC
NAPROXEN~SUSPENSION;ORAL~NAPROSYN~ROCHE PALO~25MG/ML~N~018965~001~AB~Mar 23, 198
7~Yes~RX~ROCHE PALO ALTO LLC
NAPROXEN~SUSPENSION;ORAL~NAPROXEN~ROXANE~25MG/ML~A~074190~001~AB~Mar 30, 1994~No
NALIDIXIC ACID~SUSPENSION;ORAL~NEGGRAM~SANOFI AVENTIS US~250MG/5ML~N~017430~001~
~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
NEOTRIZINE~LILLY~167MG/5ML;167MG/5ML;167MG/5ML~N~006317~012~~Approved Prior to J
an 1, 1982~No~DISCN~ELI LILLY AND CO
NEVIRAPINE~SUSPENSION;ORAL~NEVIRAPINE~AUROBINDO~50MG/5ML~A~077702~001~AA~May 22,
NYSTATIN~SUSPENSION;ORAL~NILSTAT~GLENMARK GENERICS~100,000 UNITS/ML~N~050299~001
~~Approved Prior to Jan 1, 1982~No~DISCN~GLENMARK GENERICS INC USA
NITROFURANTOIN~SUSPENSION;ORAL~NITROFURANTOIN~AMNEAL PHARMS~25MG/5ML~A~201679~00
1~AB~May 11, 2011~No~RX~AMNEAL PHARMACEUTICALS
NITROFURANTOIN~SUSPENSION;ORAL~NITROFURANTOIN~NOVEL LABS INC~25MG/5ML~A~201693~0
01~AB~Sep 8, 2014~No~RX~NOVEL LABORATORIES INC
NITROFURANTOIN~SUSPENSION;ORAL~NITROFURANTOIN~SUN PHARM INDS INC~25MG/5ML~A~2013
55~001~AB~Aug 14, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
KETOCONAZOLE~SUSPENSION;ORAL~NIZORAL~JANSSEN PHARMA~100MG/5ML~A~070767~001~~Nov
7, 1986~No~DISCN~JANSSEN PHARMACEUTICA PRODUCTS LP
LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS~SUSPENSION;ORAL~NOVRAD~LILLY~EQ 50MG BASE/5
ML~N~012928~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY INDUSTRIES INC
POSACONAZOLE~SUSPENSION;ORAL~NOXAFIL~SCHERING~40MG/ML~N~022003~001~~Sep 15, 2006

~Yes~RX~SCHERING CORP
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~ACTAVIS MID ATLANTIC~100,000 UNITS/ML~A~062349
~001~AA~Jul 14, 1982~No~RX~ACTAVIS MID ATLANTIC LLC
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~ALPHARMA US PHARMS~100,000 UNITS/ML~A~062571~0
01~~Oct 29, 1985~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~FOUGERA~100,000 UNITS/ML~A~062517~001~AA~Jun 7
, 1984~No~RX~E FOUGERA DIV ALTANA INC
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~HI TECH PHARMA~100,000 UNITS/ML~A~064042~001~A
A~Feb 28, 1994~No~RX~HI TECH PHARMACAL CO INC
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~MORTON GROVE~100,000 UNITS/ML~A~062835~001~~No
v 19, 1987~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~PHARMADERM~100,000 UNITS/ML~A~062518~001~~Jul
6, 1984~No~DISCN~PHARMADERM DIV ALTANA INC
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~PHARMAFAIR~100,000 UNITS/ML~A~062541~001~~Jan
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~ROXANE~100,000 UNITS/ML~A~062832~001~~Dec 27,
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~TARO~100,000 UNITS/ML~A~062876~001~AA~Feb 29,
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~TEVA~100,000 UNITS/ML~A~062670~001~~Jun 18, 19
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~TEVA~100,000 UNITS/ML~A~062776~001~~Dec 17, 19
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~VINTAGE PHARMS~100,000 UNITS/ML~A~065148~001~A
A~Jun 28, 2005~No~RX~VINTAGE PHARMACEUTICALS INC
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~VISTAPHARM~100,000 UNITS/ML~A~064142~001~AA~Ju
n 25, 1998~No~RX~VISTAPHARM INC
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~VISTAPHARM~100,000 UNITS/ML~A~065422~001~AA~Ma
r 7, 2011~No~RX~VISTAPHARM INC
NYSTATIN~SUSPENSION;ORAL~NYSTATIN~WOCKHARDT~100,000 UNITS/ML~A~062512~001~AA~Oct
29, 1984~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
NYSTATIN~SUSPENSION;ORAL~NYSTEX~SAVAGE LABS~100,000 UNITS/ML~A~062519~001~~Jul 6
, 1984~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
CLOBAZAM~SUSPENSION;ORAL~ONFI~LUNDBECK LLC~2.5MG/ML~N~203993~001~~Dec 14, 2012~Y
es~RX~LUNDBECK LLC
OXCARBAZEPINE~SUSPENSION;ORAL~OXCARBAZEPINE~AMNEAL PHARMS~300MG/5ML~A~202961~001
~AB~Sep 17, 2012~No~RX~AMNEAL PHARMACEUTICALS
OXCARBAZEPINE~SUSPENSION;ORAL~OXCARBAZEPINE~RANBAXY~300MG/5ML~A~078734~001~AB~Ju
n 26, 2009~No~RX~RANBAXY LABORATORIES LTD
OXCARBAZEPINE~SUSPENSION;ORAL~OXCARBAZEPINE~ROXANE~300MG/5ML~A~201193~001~AB~Oct
PAROXETINE HYDROCHLORIDE~SUSPENSION;ORAL~PAROXETINE HYDROCHLORIDE~APOTEX INC~EQ
10MG BASE/5ML~A~077395~001~~Dec 5, 2006~No~DISCN~APOTEX INC
PAROXETINE HYDROCHLORIDE~SUSPENSION;ORAL~PAXIL~APOTEX TECHNOLOGIES~EQ 10MG BASE/
5ML~N~020710~001~AB~Jun 25, 1997~Yes~RX~APOTEX TECHNOLOGIES INC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~PEDIAMYCIN~ARBOR PHARMS LLC~EQ 200MG
BASE/5ML~A~062304~001~AB~Approved Prior to Jan 1, 1982~No~RX~ARBOR PHARMACEUTIC
ALS LLC
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~PEDIAMYCIN 400~ARBOR PHARMS LLC~EQ 4
00MG BASE/5ML~A~062304~002~AB~Approved Prior to Jan 1, 1982~No~RX~ARBOR PHARMACE
UTICALS LLC
PHENYTOIN~SUSPENSION;ORAL~PHENYTOIN~ACTAVIS MID ATLANTIC~125MG/5ML~A~089892~001~
~Sep 25, 1992~No~DISCN~ACTAVIS MID ATLANTIC LLC
PHENYTOIN~SUSPENSION;ORAL~PHENYTOIN~TARO~125MG/5ML~A~040521~001~AB~Mar 8, 2004~N
PHENYTOIN~SUSPENSION;ORAL~PHENYTOIN~VISTAPHARM~125MG/5ML~A~040342~001~AB~Jan 31,
PHENYTOIN~SUSPENSION;ORAL~PHENYTOIN~VISTAPHARM~125MG/5ML~A~040610~001~AB~Aug 18,
PHENYTOIN~SUSPENSION;ORAL~PHENYTOIN~WOCKHARDT~125MG/5ML~A~040420~001~AB~Apr 19,
PYRVINIUM PAMOATE~SUSPENSION;ORAL~POVAN~PARKE DAVIS~EQ 50MG BASE/5ML~N~011964~00
DARUNAVIR ETHANOLATE~SUSPENSION;ORAL~PREZISTA~JANSSEN PRODS~EQ 100MG BASE/ML~N~2
02895~001~~Dec 16, 2011~Yes~RX~JANSSEN PRODUCTS LP
DIAZOXIDE~SUSPENSION;ORAL~PROGLYCEM~TEVA BRANDED PHARM~50MG/ML~N~017453~001~~App
roved Prior to Jan 1, 1982~Yes~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D I
NC
CISAPRIDE MONOHYDRATE~SUSPENSION;ORAL~PROPULSID~JANSSEN PHARMS~EQ 1MG BASE/ML~N~
020398~001~~Sep 15, 1995~No~DISCN~JANSSEN PHARMACEUTICALS INC
MERCAPTOPURINE~SUSPENSION;ORAL~PURIXAN~NOVA LABS LTD~20MG/ML~N~205919~001~~Apr 2
8, 2014~Yes~RX~NOVA LABORATORIES LTD
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~SEPTRA~MONARCH PHARMS~200MG/5ML;4
0MG/5ML~N~017598~001~~Approved Prior to Jan 1, 1982~No~DISCN~MONARCH PHARMACEUTI
CALS INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~SEPTRA GRAPE~MONARCH PHARMS~200MG
/5ML;40MG/5ML~N~017598~002~~Feb 12, 1986~No~DISCN~MONARCH PHARMACEUTICALS INC
SIMETHICONE-CELLULOSE~SUSPENSION;ORAL~SONORX~BRACCO~7.5MG/ML~N~020773~001~~Oct 2
9, 1998~No~DISCN~BRACCO DIAGNOSTICS INC
SULFAPHENAZOLE~SUSPENSION;ORAL~SULFABID~PHARM RES ASSOC~500MG/5ML~N~013093~001~~
Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
SULFALOID~FOREST PHARMS~167MG/5ML;167MG/5ML;167MG/5ML~A~080100~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~FOREST PHARMACEUTICALS INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM
~AUROBINDO PHARMA~200MG/5ML;40MG/5ML~A~091348~001~AB~Jun 8, 2010~No~RX~AUROBINDO
PHARMA LTD
~HI TECH PHARMA~200MG/5ML;40MG/5ML~A~074650~001~AB~Dec 29, 1997~Yes~RX~HI TECH P
HARMACAL CO INC
~TEVA~200MG/5ML;40MG/5ML~A~070028~001~~Jun 2, 1987~No~DISCN~TEVA PHARMACEUTICALS
USA INC
~TEVA~200MG/5ML;40MG/5ML~N~018812~001~~Jan 28, 1983~No~DISCN~TEVA PHARMACEUTICAL
S USA INC
~TEVA~200MG/5ML;40MG/5ML~N~018812~002~~Jun 10, 1983~No~DISCN~TEVA PHARMACEUTICAL
S USA INC
~TEVA PHARMS~200MG/5ML;40MG/5ML~A~077612~001~~Nov 13, 2006~No~DISCN~TEVA PHARMAC
EUTICALS USA
~VINTAGE~200MG/5ML;40MG/5ML~A~077785~001~AB~Jan 24, 2007~No~RX~VINTAGE PHARMACEU
TICALS LLC
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~SULFATRIM~STI PHARMA LLC~200MG/5M
L;40MG/5ML~N~018615~002~~Jan 7, 1983~No~DISCN~STI PHARMA LLC
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~SULFATRIM PEDIATRIC~STI PHARMA LL
C~200MG/5ML;40MG/5ML~N~018615~001~AB~Jan 7, 1983~No~RX~STI PHARMA LLC
SULFADIAZINE; SULFAMERAZINE~SUSPENSION;ORAL~SULFONAMIDES DUPLEX~LILLY~250MG/5ML;
250MG/5ML~N~006317~007~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
SULFOSE~WYETH AYERST~167MG/5ML;167MG/5ML;167MG/5ML~A~080013~002~~Approved Prior
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~SULMEPRIM~USL PHARMA~200MG/5ML;40
MG/5ML~A~070063~001~~Aug 1, 1986~No~DISCN~USL PHARMA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~SULMEPRIM PEDIATRIC~USL PHARMA~20
0MG/5ML;40MG/5ML~A~070064~001~~Aug 1, 1986~No~DISCN~USL PHARMA INC
TETRACYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~SUMYCIN~PAR PHARM~125MG/5ML~A~060400~
001~~Approved Prior to Jan 1, 1982~No~DISCN~PAR PHARMACEUTICAL

CIMETIDINE~SUSPENSION;ORAL~TAGAMET HB 200~GLAXOSMITHKLINE~200MG/20ML~N~020951~00
1~~Jul 9, 1999~No~DISCN~GLAXOSMITHKLINE
TROLEANDOMYCIN~SUSPENSION;ORAL~TAO~PFIZER~EQ 125MG BASE/5ML~N~050332~001~~Approv
CARBAMAZEPINE~SUSPENSION;ORAL~TEGRETOL~NOVARTIS~100MG/5ML~N~018927~001~AB~Dec 18
, 1987~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
TERFONYL~BRISTOL MYERS SQUIBB~167MG/5ML;167MG/5ML;167MG/5ML~N~006904~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
CARBAMAZEPINE~SUSPENSION;ORAL~TERIL~TARO~100MG/5ML~A~076729~001~AB~Sep 20, 2004~
No~RX~TARO PHARMACEUTICALS USA INC
TETRACYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~TETRACYCLINE HYDROCHLORIDE~ALPHARMA U
S PHARMS~125MG/5ML~A~060633~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA
US PHARMACEUTICALS DIVISION
TETRACYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~TETRACYCLINE HYDROCHLORIDE~FERRANTE~1
25MG/5ML~A~060174~001~~Approved Prior to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
TETRACYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~TETRACYCLINE HYDROCHLORIDE~PROTER~125
MG/5ML~A~060446~001~~Approved Prior to Jan 1, 1982~No~DISCN~PROTER LABORATORY SP
A
TETRACYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~TETRACYCLINE HYDROCHLORIDE~PUREPAC PH
ARM~125MG/5ML~A~060291~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARM
ACEUTICAL CO
TETRACYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~TETRACYN~PFIPHARMECS~125MG/5ML~A~0600
95~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIPHARMECS DIV PFIZER INC
TETRACYCLINE HYDROCHLORIDE~SUSPENSION;ORAL~TETRAMED~IVAX SUB TEVA PHARMS~125MG/5
ML~A~061468~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
SUB TEVA PHARMACEUTICALS USA
NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; TYROSINE~SUSPENSION;ORAL~TPN~INTL MINERAL
S~15MG/5ML;3.75MG/5ML;600MG/5ML~N~008378~003~~Approved Prior to Jan 1, 1982~No~D
ISCN~INTERNATIONAL MINERALS CHEMICAL CORP
OXCARBAZEPINE~SUSPENSION;ORAL~TRILEPTAL~NOVARTIS~300MG/5ML~N~021285~001~AB~May 2
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~TRIMETH/SULFA~ALPHARMA US PHARMS~
200MG/5ML;40MG/5ML~A~072289~001~~May 23, 1988~No~DISCN~ALPHARMA US PHARMACEUTICA
LS DIVISION
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~TRIMETH/SULFA~ALPHARMA US PHARMS~
200MG/5ML;40MG/5ML~A~072398~001~~May 23, 1988~No~DISCN~ALPHARMA US PHARMACEUTICA
LS DIVISION
SULFAMETHOXAZOLE; TRIMETHOPRIM~SUSPENSION;ORAL~TRIMETH/SULFA~NASKA~200MG/5ML;40M
G/5ML~A~072399~001~~May 23, 1988~No~DISCN~NASKA PHARMACAL CO INC DIV RUGBY DARBY
GROUP COSMETICS
TRIPLE SULFA~ALPHARMA US PHARMS~167MG/5ML;167MG/5ML;167MG/5ML~A~080280~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
TRIPLE SULFAS~LEDERLE~167MG/5ML;167MG/5ML;167MG/5ML~N~006920~003~~Approved Prior
to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
CLOZAPINE~SUSPENSION;ORAL~VERSACLOZ~JAZZ PHARMS III~50MG/ML~N~203479~001~~Feb 6,
2013~Yes~RX~JAZZ PHARMACEUTICALS INTERNATIONAL III
TRIFLUPROMAZINE~SUSPENSION;ORAL~VESPRIN~APOTHECON~EQ 50MG HCL/5ML~N~011491~004~~
Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL MYERS SQUIBB CO
DOXYCYCLINE CALCIUM~SUSPENSION;ORAL~VIBRAMYCIN~PFIZER~EQ 50MG BASE/5ML~N~050480~
001~~Approved Prior to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC
ROFECOXIB~SUSPENSION;ORAL~VIOXX~MERCK~12.5MG/5ML~N~021052~001~~May 20, 1999~No~D
ISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
ROFECOXIB~SUSPENSION;ORAL~VIOXX~MERCK~25MG/5ML~N~021052~002~~May 20, 1999~No~DIS
CN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
NEVIRAPINE~SUSPENSION;ORAL~VIRAMUNE~BOEHRINGER INGELHEIM~50MG/5ML~N~020933~001~A
A~Sep 11, 1998~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
HYDROXYZINE PAMOATE~SUSPENSION;ORAL~VISTARIL~PFIZER~EQ 25MG HCL/5ML~N~011795~001

ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~WYAMYCIN E~WYETH AYERST~EQ 200MG BAS
E/5ML~A~062123~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATO
RIES
ERYTHROMYCIN ETHYLSUCCINATE~SUSPENSION;ORAL~WYAMYCIN E~WYETH AYERST~EQ 400MG BAS
E/5ML~A~062123~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATO
RIES
ACYCLOVIR~SUSPENSION;ORAL~ZOVIRAX~DELCOR ASSET~200MG/5ML~N~019909~001~AB~Dec 22,
1989~Yes~RX~DELCOR ASSET CORP
SODIUM POLYSTYRENE SULFONATE~SUSPENSION;ORAL, RECTAL~KIONEX~PADDOCK LLC~15GM/60M
L~A~040028~001~AA~Sep 17, 2007~No~RX~PADDOCK LABORATORIES LLC
SODIUM POLYSTYRENE SULFONATE~SUSPENSION;ORAL, RECTAL~SODIUM POLYSTYRENE SULFONAT
E~MORTON GROVE~15GM/60ML~A~088717~001~~Sep 11, 1984~No~DISCN~MORTON GROVE PHARMA
CEUTICALS INC
E~PADDOCK LLC~15GM/60ML~A~090590~001~AA~May 13, 2011~No~RX~PADDOCK LABORATORIES
LLC
E~ROXANE~15GM/60ML~A~088453~001~~Nov 17, 1983~No~DISCN~ROXANE LABORATORIES INC
E~ROXANE~15GM/60ML~A~089049~001~AA~Nov 17, 1986~No~RX~ROXANE LABORATORIES INC
SODIUM POLYSTYRENE SULFONATE~SUSPENSION;ORAL, RECTAL~SPS~CAROLINA MEDCL~15GM/60M
L~A~087859~001~AA~Dec 8, 1982~Yes~RX~CAROLINA MEDICAL PRODUCTS CO
THIOPENTAL SODIUM~SUSPENSION;RECTAL~PENTOTHAL~ABBOTT~400MG/GM~N~011679~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES HOSP PRODUCTS DIV
CICLOPIROX~SUSPENSION;TOPICAL~CICLOPIROX~FOUGERA PHARMS~0.77%~A~076422~001~AB~Au
g 6, 2004~No~RX~FOUGERA PHARMACEUTICALS INC
CICLOPIROX~SUSPENSION;TOPICAL~CICLOPIROX~PERRIGO NEW YORK~0.77%~A~077676~001~AB~
Dec 15, 2006~No~RX~PERRIGO NEW YORK INC
CICLOPIROX~SUSPENSION;TOPICAL~CICLOPIROX~TARO~0.77%~A~077092~001~AB~Aug 10, 2005
~No~RX~TARO PHARMACEUTICALS USA INC
CICLOPIROX~SUSPENSION;TOPICAL~LOPROX~MEDIMETRIKS PHARMS~0.77%~N~019824~001~AB~De
c 30, 1988~Yes~RX~MEDIMETRIKS PHARMACEUTICALS INC
SPINOSAD~SUSPENSION;TOPICAL~NATROBA~PARAPRO LLC~0.9%~N~022408~001~~Jan 18, 2011~
Yes~RX~PARAPRO LLC
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE~SUSPENSION;TOPICAL~TACLONEX~LE
O PHARMA AS~0.064%;0.005%~N~022185~001~~May 9, 2008~Yes~RX~LEO PHARMA AS
ERYTHROMYCIN~SWAB;TOPICAL~C-SOLVE-2~IVAX SUB TEVA PHARMS~2%~A~062751~001~~Jul 30
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SWAB;TOPICAL~CHLORAPREP ONE-STEP SEPP
~CAREFUSION~2%;70% (0.67ML)~N~021555~001~~Oct 7, 2002~Yes~OTC~CAREFUSION 213 LLC
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SWAB;TOPICAL~CHLORAPREP SINGLE SWABST
ICK~CAREFUSION~2%;70% (1.75ML)~N~021555~002~~May 10, 2005~Yes~OTC~CAREFUSION 213
LLC
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SWAB;TOPICAL~CHLORAPREP TRIPLE SWABST
ICK~CAREFUSION~2%;70% (5.25ML)~N~021555~003~~Jun 10, 2009~Yes~OTC~CAREFUSION 213
LLC
CLINDAMYCIN PHOSPHATE~SWAB;TOPICAL~CLEOCIN~PHARMACIA AND UPJOHN~EQ 1% BASE~N~050
537~002~AT~Feb 22, 1994~No~RX~PHARMACIA AND UPJOHN CO
CLINDAMYCIN PHOSPHATE~SWAB;TOPICAL~CLINDAMYCIN PHOSPHATE~PERRIGO NEW YORK~EQ 1%
BASE~A~065049~001~AT~May 25, 2000~No~RX~PERRIGO NEW YORK INC
CLINDAMYCIN PHOSPHATE~SWAB;TOPICAL~CLINDAMYCIN PHOSPHATE~VERSAPHARM~EQ 1% BASE~A
~065513~001~AT~Jun 17, 2010~No~RX~VERSAPHARM INC
CLINDAMYCIN PHOSPHATE~SWAB;TOPICAL~CLINDETS~PERRIGO~EQ 1% BASE~A~064136~001~AT~S
ep 30, 1996~No~RX~PERRIGO CO
ERYTHROMYCIN~SWAB;TOPICAL~ERYCETTE~JOHNSON AND JOHNSON~2%~N~050594~001~~Feb 15,
1985~No~DISCN~JOHNSON AND JOHNSON CONSUMER COMPANIES INC
ERYTHROMYCIN~SWAB;TOPICAL~ERYTHROMYCIN~FOUGERA PHARMS~2%~A~065320~001~~Jul 25, 2
006~No~DISCN~FOUGERA PHARMACEUTICALS INC
ERYTHROMYCIN~SWAB;TOPICAL~ERYTHROMYCIN~PERRIGO~2%~A~064126~001~AT~Jul 3, 1996~Ye
s~RX~PERRIGO CO
ERYTHROMYCIN~SWAB;TOPICAL~ERYTHROMYCIN~RENAISSANCE PHARMA~2%~A~064128~001~~Jul 3
, 1996~No~DISCN~RENAISSANCE PHARMA US HOLDINGS INC
ERYTHROMYCIN~SWAB;TOPICAL~ERYTHROMYCIN~VERSAPHARM~2%~A~090215~001~AT~May 12, 201
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SWAB;TOPICAL~PREVANTICS MAXI SWABSTIC
K~PROF DSPLS~3.15%;70% (5.1ML)~N~021524~003~~Jun 3, 2005~Yes~OTC~PROFESSIONAL DI
SPOSABLES INC
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SWAB;TOPICAL~PREVANTICS SWAB~PROF DSP
LS~3.15%;70% (1ML)~N~021524~001~~Jun 3, 2005~Yes~OTC~PROFESSIONAL DISPOSABLES IN
C
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL~SWAB;TOPICAL~PREVANTICS SWABSTICK~PRO
F DSPLS~3.15%;70% (1.6ML)~N~021524~002~~Jun 3, 2005~Yes~OTC~PROFESSIONAL DISPOSA
BLES INC
TRETINOIN~SWAB;TOPICAL~RETIN-A~VALEANT INTL~0.05%~N~016921~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~VALEANT INTERNATIONAL BARBADOS SRL
ERYTHROMYCIN~SWAB;TOPICAL~T-STAT~WESTWOOD SQUIBB~2%~A~062748~001~~Jul 23, 1987~N
o~DISCN~WESTWOOD SQUIBB PHARMACEUTICALS INC
THEOPHYLLINE~SYRUP;ORAL~ACCURBRON~SANOFI AVENTIS US~150MG/15ML~A~088746~001~~Nov
22, 1985~No~DISCN~SANOFI AVENTIS US LLC
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~ACTAHIST~CE
NCI~30MG/5ML;1.25MG/5ML~A~088344~001~~Feb 9, 1984~No~DISCN~HR CENCI LABORATORIES
INC
TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~ACTIDIL~GLAXOSMITHKLINE~1.25MG/5ML~N~01149
6~002~~Jul 1, 1983~No~DISCN~GLAXOSMITHKLINE
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~SYR
UP;ORAL~ACTIFED W/ CODEINE~GLAXOSMITHKLINE~10MG/5ML;30MG/5ML;1.25MG/5ML~N~012575
~003~~Apr 4, 1984~No~DISCN~GLAXOSMITHKLINE
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~ACTAVIS MID ATLANTIC~EQ 2MG BASE/
5ML~A~074454~001~AA~Sep 25, 1995~No~RX~ACTAVIS MID ATLANTIC LLC
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~ACTAVIS MID ATLANTIC~EQ 2MG BASE/
5ML~A~075262~001~~Mar 30, 1999~No~DISCN~ACTAVIS MID ATLANTIC LLC
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~AMNEAL PHARMS~EQ 2MG BASE/5ML~A~0
79241~001~AA~May 12, 2010~No~RX~AMNEAL PHARMACEUTICALS
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~HI TECH PHARMA~EQ 2MG BASE/5ML~A~
074749~001~AA~Jan 30, 1998~No~RX~HI TECH PHARMACAL CO INC
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~MOVA~EQ 2MG BASE/5ML~A~074302~001
~~Sep 30, 1994~No~DISCN~MOVA PHARMACEUTICALS CORP
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~TEVA~EQ 2MG BASE/5ML~A~073419~001
~AA~Mar 30, 1992~Yes~RX~TEVA PHARMACEUTICALS USA INC
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~VINTAGE~EQ 2MG BASE/5ML~A~078105~
001~AA~Dec 27, 2006~No~RX~VINTAGE PHARMACEUTICALS LLC
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~VISTAPHARM~EQ 2MG BASE/5ML~A~0777
88~001~AA~Jun 26, 2007~No~RX~VISTAPHARM INC
ALBUTEROL SULFATE~SYRUP;ORAL~ALBUTEROL SULFATE~WATSON LABS~EQ 2MG BASE/5ML~A~073
METAPROTERENOL SULFATE~SYRUP;ORAL~ALUPENT~BOEHRINGER INGELHEIM~10MG/5ML~N~017571
~001~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER INGELHEIM
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~ACTAVIS MID ATLANTI
C~50MG/5ML~A~072655~001~~Oct 30, 1990~No~DISCN~ACTAVIS MID ATLANTIC LLC
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~CAROLINA MEDCL~50MG
/5ML~A~075819~001~AA~Sep 11, 2002~Yes~RX~CAROLINA MEDICAL PRODUCTS CO
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~HI TECH PHARMA~50MG
/5ML~A~074170~001~AA~Oct 28, 1994~Yes~RX~HI TECH PHARMACAL CO INC
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~MIKART~50MG/5ML~A~0
74028~001~AA~Jun 28, 1993~Yes~RX~MIKART INC
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~PHARM ASSOC~50MG/5M
L~A~074509~001~AA~Jul 17, 1995~Yes~RX~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCT
S
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~SILARX~50MG/5ML~A~0

76352~001~AA~Sep 10, 2004~Yes~RX~SILARX PHARMACEUTICALS INC
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~TEVA PHARMS~50MG/5M
L~A~073115~001~~Aug 23, 1991~No~DISCN~TEVA PHARMACEUTICALS USA
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~VINTAGE~50MG/5ML~A~
077992~001~AA~Dec 12, 2006~Yes~RX~VINTAGE PHARMACEUTICALS LLC
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~AMANTADINE HYDROCHLORIDE~WOCKHARDT~50MG/5ML~
A~075060~001~AA~Dec 24, 1998~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE~SYRUP;ORAL~AMBENYL~FOREST
LABS~12.5MG/5ML;10MG/5ML~N~009319~006~~Jan 10, 1984~No~DISCN~FOREST LABORATORIES
INC
AMINOCAPROIC ACID~SYRUP;ORAL~AMICAR~CLOVER PHARMS~1.25GM/5ML~N~015230~002~AA~App
roved Prior to Jan 1, 1982~Yes~RX~CLOVER PHARMACEUTICALS CORP
AMINOCAPROIC ACID~SYRUP;ORAL~AMINOCAPROIC ACID~MIKART~1.25GM/5ML~A~074759~001~AA
~Sep 2, 1998~No~RX~MIKART INC
PIPERAZINE CITRATE~SYRUP;ORAL~ANTEPAR~GLAXOSMITHKLINE~EQ 500MG BASE/5ML~N~009102
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~ANTITUSSIVE~PERRIGO~12.5MG/5ML~A~071292
~001~~Apr 10, 1987~No~DISCN~L PERRIGO CO
THEOPHYLLINE~SYRUP;ORAL~AQUAPHYLLIN~FERNDALE LABS~80MG/15ML~A~087917~001~~Jan 18
, 1983~No~DISCN~FERNDALE LABORATORIES INC
TRIAMCINOLONE DIACETATE~SYRUP;ORAL~ARISTOCORT~ASTELLAS~2MG/5ML~N~011960~004~~App
HYDROXYZINE HYDROCHLORIDE~SYRUP;ORAL~ATARAX~ROERIG~10MG/5ML~N~010485~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ROERIG DIV PFIZER INC
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~BELDIN~HALSEY~12.5MG/5ML~A~089179~001~~
Jun 5, 1986~No~DISCN~HALSEY DRUG CO INC
DICYCLOMINE HYDROCHLORIDE~SYRUP;ORAL~BENTYL~APTALIS PHARMA US~10MG/5ML~N~007961~
002~AA~Oct 15, 1984~Yes~RX~APTALIS PHARMA US INC
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~BENYLIN~PARKE DAVIS~12.5MG/5ML~N~006514
~004~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHL
ORIDE~SYRUP;ORAL~BROMANATE DM~ALPHARMA US PHARMS~2MG/5ML;10MG/5ML;30MG/5ML~A~088
722~001~~Mar 7, 1985~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE~SYRUP;ORAL~BROMANYL~ALPHAR
MA US PHARMS~12.5MG/5ML;10MG/5ML~A~088343~001~~Aug 15, 1984~No~DISCN~ALPHARMA US
PHARMACEUTICALS DIVISION
ORIDE~SYRUP;ORAL~BROMFED-DM~WOCKHARDT~2MG/5ML;10MG/5ML;30MG/5ML~A~088811~001~AA~
Jun 7, 1985~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
ORIDE~SYRUP;ORAL~BROMFED-DM~WOCKHARDT~2MG/5ML;10MG/5ML;30MG/5ML~A~089681~001~~De
c 22, 1988~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE~SYRUP;ORAL~BROMODIPHENHYDR
AMINE HYDROCHLORIDE AND CODEINE PHOSPHATE~WOCKHARDT~12.5MG/5ML;10MG/5ML~A~088626
~001~~Oct 12, 1984~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
ORIDE~SYRUP;ORAL~BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXT
ROMETHORPHAN HYDROBROMIDE~PADDOCK LLC~2MG/5ML;10MG/5ML;30MG/5ML~A~205292~001~AA~
Jul 15, 2014~No~RX~PADDOCK LABORATORIES LLC
ORIDE~SYRUP;ORAL~BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXT
ROMETHORPHAN HYDROBROMIDE~VINTAGE PHARMS~2MG/5ML;10MG/5ML;30MG/5ML~A~202940~001~
AA~Jul 21, 2014~No~RX~VINTAGE PHARMACEUTICALS
PIPERAZINE CITRATE~SYRUP;ORAL~BRYREL~SANOFI AVENTIS US~EQ 500MG BASE/5ML~N~01779
BETAMETHASONE~SYRUP;ORAL~CELESTONE~MERCK SHARP DOHME~0.6MG/5ML~N~014215~002~~App
roved Prior to Jan 1, 1982~No~DISCN~MERCK SHARP AND DOHME CORP
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~ACTAVIS MID ATLANTI
C~5MG/5ML~A~078617~001~~Feb 2, 2010~No~DISCN~ACTAVIS MID ATLANTIC LLC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~AMNEAL PHARMS~5MG/5

ML~A~090766~001~AA~Oct 7, 2009~No~RX~AMNEAL PHARMACEUTICALS
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~APOTEX INC~5MG/5ML~
A~078412~001~~Jun 18, 2008~No~DISCN~APOTEX INC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~AUROBINDO PHARMA LT
D~5MG/5ML~A~090751~001~~Dec 16, 2009~No~DISCN~AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~BIO PHARM INC~5MG/5
ML~A~078870~001~AA~Apr 27, 2009~No~RX~BIO PHARM INC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~BRECKENRIDGE PHARM~
5MG/5ML~A~078488~001~AA~Oct 6, 2008~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~PERRIGO R AND D~5MG
/5ML~A~078398~001~AA~Jun 17, 2008~No~RX~PERRIGO R AND D CO
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~RANBAXY LABS LTD~5M
G/5ML~A~077472~001~~Jun 18, 2008~No~DISCN~RANBAXY LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~SILARX~5MG/5ML~A~07
8876~001~AA~May 11, 2012~No~RX~SILARX PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~SUN PHARM INDS INC~
5MG/5ML~A~090191~001~AA~Nov 12, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~TARO~5MG/5ML~A~0766
01~001~AA~Jun 20, 2008~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~TEVA PHARMS~5MG/5ML
~A~077279~001~AA~May 27, 2008~No~RX~TEVA PHARMACEUTICALS USA
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~VINTAGE~5MG/5ML~A~0
78496~001~AA~Sep 25, 2009~No~RX~VINTAGE PHARMACEUTICALS LLC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CETIRIZINE HYDROCHLORIDE~WOCKHARDT~5MG/5ML~A
~078757~001~AA~Aug 28, 2009~No~RX~WOCKHARDT LTD
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY~
ACTAVIS MID ATLANTIC~5MG/5ML~A~090378~002~~May 9, 2008~No~DISCN~ACTAVIS MID ATLA
NTIC LLC
AMNEAL PHARMS~5MG/5ML~A~090765~002~~Oct 7, 2009~No~OTC~AMNEAL PHARMACEUTICALS
APOTEX INC~5MG/5ML~A~090188~002~~Apr 22, 2008~No~DISCN~APOTEX INC
AUROBINDO PHARMA~5MG/5ML~A~090750~002~~Feb 2, 2010~No~OTC~AUROBINDO PHARMA LTD
BIO PHARM INC~5MG/5ML~A~090474~002~~Mar 30, 2009~No~OTC~BIO PHARM INC
CYPRESS PHARM~5MG/5ML~A~090300~001~~Oct 10, 2008~No~OTC~CYPRESS PHARMACEUTICAL I
NC
PERRIGO R AND D~5MG/5ML~A~204226~001~~Sep 9, 2013~No~OTC~PERRIGO R AND D CO
PERRIGO R AND D~5MG/5ML~A~090254~002~~Apr 9, 2008~No~OTC~PERRIGO R AND D CO
RANBAXY LABS LTD~5MG/5ML~A~090183~002~~Apr 24, 2008~No~DISCN~RANBAXY LABORATORIE
S LTD
SILARX~5MG/5ML~A~091130~001~~Apr 22, 2011~No~OTC~SILARX PHARMACEUTICALS INC
SUN PHARM INDS INC~5MG/5ML~A~091327~001~~Oct 17, 2011~No~OTC~SUN PHARMACEUTICAL
INDUSTRIES INC
TARO~5MG/5ML~A~090182~002~~Apr 22, 2008~No~OTC~TARO PHARMACEUTICAL INDUSTRIES LT
D
TARO~5MG/5ML~A~201546~001~~May 20, 2011~No~OTC~TARO PHARMACEUTICAL INDUSTRIES LT
D
TRIS PHARMA INC~5MG/5ML~A~090572~001~~Nov 16, 2012~No~OTC~TRIS PHARMA INC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RE

LIEF~ACTAVIS MID ATLANTIC~5MG/5ML~A~090378~001~~May 9, 2008~No~DISCN~ACTAVIS MID
ATLANTIC LLC
LIEF~AMNEAL PHARMS~5MG/5ML~A~090765~001~~Oct 7, 2009~No~OTC~AMNEAL PHARMACEUTICA
LS
LIEF~APOTEX INC~5MG/5ML~A~090188~001~~Apr 22, 2008~No~DISCN~APOTEX INC
LIEF~AUROBINDO PHARMA~5MG/5ML~A~090750~001~~Feb 2, 2010~No~OTC~AUROBINDO PHARMA
LTD
LIEF~BIO PHARM INC~5MG/5ML~A~090474~001~~Mar 30, 2009~No~OTC~BIO PHARM INC
LIEF~CYPRESS PHARM~5MG/5ML~A~090300~002~~Oct 10, 2008~No~OTC~CYPRESS PHARMACEUTI
CAL INC
LIEF~PERRIGO R AND D~5MG/5ML~A~090254~001~~Apr 9, 2008~No~OTC~PERRIGO R AND D CO
LIEF~RANBAXY LABS LTD~5MG/5ML~A~090183~001~~Apr 24, 2008~No~DISCN~RANBAXY LABORA
TORIES LTD
LIEF~SILARX~5MG/5ML~A~091130~002~~Apr 22, 2011~No~OTC~SILARX PHARMACEUTICALS INC
LIEF~SUN PHARM INDS INC~5MG/5ML~A~091327~002~~Oct 17, 2011~No~OTC~SUN PHARMACEUT
ICAL INDUSTRIES INC
LIEF~TARO~5MG/5ML~A~090182~001~~Apr 22, 2008~No~OTC~TARO PHARMACEUTICAL INDUSTRI
ES LTD
LIEF~TARO~5MG/5ML~A~201546~002~~May 20, 2011~No~OTC~TARO PHARMACEUTICAL INDUSTRI
ES LTD
LIEF~TRIS PHARMA INC~5MG/5ML~A~090572~002~~Nov 16, 2012~No~OTC~TRIS PHARMA INC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CHILDREN'S ZYRTEC ALLERGY~MCNEIL CONSUMER~5M
G/5ML~N~022155~002~~Nov 16, 2007~Yes~OTC~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL P
PC INC
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~CHILDREN'S ZYRTEC HIVES RELIEF~MCNEIL CONSUM
ER~5MG/5ML~N~022155~001~~Nov 16, 2007~Yes~OTC~MCNEIL CONSUMER HEALTHCARE DIV MCN
EIL PPC INC
CHLORPHENIRAMINE MALEATE~SYRUP;ORAL~CHLOR-TRIMETON~SCHERING~2MG/5ML~N~006921~006
CHLORPHENIRAMINE MALEATE~SYRUP;ORAL~CHLORPHENIRAMINE MALEATE~PHARM ASSOC~2MG/5ML
~A~087520~001~~Feb 10, 1982~No~DISCN~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
CHLORPROMAZINE HYDROCHLORIDE~SYRUP;ORAL~CHLORPROMAZINE HYDROCHLORIDE~ALPHARMA US
PHARMS~10MG/5ML~A~086712~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA U
S PHARMACEUTICALS DIVISION
OXTRIPHYLLINE~SYRUP;ORAL~CHOLEDYL~PARKE DAVIS~50MG/5ML~N~009268~011~~Approved Pr
ior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
LORATADINE~SYRUP;ORAL~CLARITIN~SCHERING PLOUGH~1MG/ML~N~020641~002~~Nov 27, 2002
~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
LORATADINE~SYRUP;ORAL~CLARITIN HIVES RELIEF~SCHERING PLOUGH~1MG/ML **Federal Reg
efficacy reasons**~N~020641~003~~Nov 19, 2003~No~DISCN~SCHERING PLOUGH HEALTHCA
RE PRODUCTS INC
CLEMASTINE FUMARATE~SYRUP;ORAL~CLEMASTINE FUMARATE~ACTAVIS MID ATLANTIC~EQ 0.5MG
BASE/5ML~A~074075~001~~Oct 31, 1993~No~DISCN~ACTAVIS MID ATLANTIC LLC
CLEMASTINE FUMARATE~SYRUP;ORAL~CLEMASTINE FUMARATE~APOTEX INC~EQ 0.5MG BASE/5ML~
A~075703~001~~Nov 27, 2000~No~DISCN~APOTEX INC
CLEMASTINE FUMARATE~SYRUP;ORAL~CLEMASTINE FUMARATE~SILARX~EQ 0.5MG BASE/5ML~A~07
4884~001~~Dec 17, 1997~No~DISCN~SILARX PHARMACEUTICALS INC

CLEMASTINE FUMARATE~SYRUP;ORAL~CLEMASTINE FUMARATE~TEVA~EQ 0.5MG BASE/5ML~A~0733
99~001~AA~Jun 30, 1994~Yes~RX~TEVA PHARMACEUTICALS USA INC
CLEMASTINE FUMARATE~SYRUP;ORAL~CLEMASTINE FUMARATE~TEVA PHARMS~EQ 0.5MG BASE/5ML
~A~073095~001~~Apr 21, 1992~No~DISCN~TEVA PHARMACEUTICALS USA
CLEMASTINE FUMARATE~SYRUP;ORAL~CLEMASTINE FUMARATE~WOCKHARDT~EQ 0.5MG BASE/5ML~A
~074863~001~AA~Mar 13, 1998~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE~SYRUP;ORAL~CODAMINE~AL
PHARMA US PHARMS~5MG/5ML;25MG/5ML~A~075103~001~~Sep 29, 2000~No~DISCN~ALPHARMA U
S PHARMACEUTICALS DIVISION
PROCHLORPERAZINE EDISYLATE~SYRUP;ORAL~COMPAZINE~GLAXOSMITHKLINE~EQ 5MG BASE/5ML~
N~011188~001~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
CYPROHEPTADINE HYDROCHLORIDE~SYRUP;ORAL~CYPROHEPTADINE HYDROCHLORIDE~ACTAVIS MID
ATLANTIC~2MG/5ML~A~086833~001~~Approved Prior to Jan 1, 1982~No~DISCN~ACTAVIS M
ID ATLANTIC LLC
CYPROHEPTADINE HYDROCHLORIDE~SYRUP;ORAL~CYPROHEPTADINE HYDROCHLORIDE~HALSEY~2MG/
5ML~A~089199~001~~Jul 3, 1986~No~DISCN~HALSEY DRUG CO INC
CYPROHEPTADINE HYDROCHLORIDE~SYRUP;ORAL~CYPROHEPTADINE HYDROCHLORIDE~LYNE~2MG/5M
L~A~040668~001~AA~Jun 28, 2006~Yes~RX~LYNE LABORATORIES INC
CYPROHEPTADINE HYDROCHLORIDE~SYRUP;ORAL~CYPROHEPTADINE HYDROCHLORIDE~MORTON GROV
E~2MG/5ML~A~087001~001~~Nov 4, 1982~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
CYPROHEPTADINE HYDROCHLORIDE~SYRUP;ORAL~CYPROHEPTADINE HYDROCHLORIDE~NASKA~2MG/5
ML~A~089021~001~~Dec 21, 1987~No~DISCN~NASKA PHARMACAL CO INC DIV RUGBY DARBY GR
OUP COSMETICS
CYPROHEPTADINE HYDROCHLORIDE~SYRUP;ORAL~CYPROHEPTADINE HYDROCHLORIDE~PHARM ASSOC
~2MG/5ML~A~091295~001~AA~Mar 28, 2013~No~RX~PHARMACEUTICAL ASSOC INC
DEMECLOCYCLINE HYDROCHLORIDE~SYRUP;ORAL~DECLOMYCIN~LEDERLE~75MG/5ML~N~050257~001
~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANA
MID CO
MEPERIDINE HYDROCHLORIDE~SYRUP;ORAL~DEMEROL~SANOFI AVENTIS US~50MG/5ML~N~005010~
VALPROIC ACID~SYRUP;ORAL~DEPAKENE~ABBVIE~250MG/5ML~N~018082~001~AA~Approved Prio
r to Jan 1, 1982~Yes~RX~ABBVIE INC
DEXCHLORPHENIRAMINE MALEATE~SYRUP;ORAL~DEXCHLORPHENIRAMINE MALEATE~WOCKHARDT~2MG
/5ML~A~088251~001~~Mar 23, 1984~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
DICYCLOMINE HYDROCHLORIDE~SYRUP;ORAL~DICYCLOMINE HYDROCHLORIDE~ALPHARMA US PHARM
S~10MG/5ML~A~084479~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHAR
MACEUTICALS DIVISION
DICYCLOMINE HYDROCHLORIDE~SYRUP;ORAL~DICYCLOMINE HYDROCHLORIDE~MIKART~10MG/5ML~A
~040169~001~AA~Mar 24, 2005~No~RX~MIKART INC
ORIDE~SYRUP;ORAL~DIMETANE-DX~ROBINS AH~2MG/5ML;10MG/5ML;30MG/5ML~N~019279~001~~A
ug 24, 1984~No~DISCN~AH ROBINS CO
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~DIPHEN~MORTON GROVE~12.5MG/5ML~A~070118
~001~~Oct 1, 1985~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~ALPHARMA
US PHARMS~12.5MG/5ML~A~070497~001~~Apr 25, 1989~No~DISCN~ALPHARMA US PHARMACEUTI
CALS DIVISION
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~CUMBERLAN
D SWAN~12.5MG/5ML~A~073611~001~~Aug 20, 1992~No~DISCN~CUMBERLAND SWAN INC
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~HI TECH P
HARMA~12.5MG/5ML~A~072416~001~~Sep 28, 1990~No~DISCN~HI TECH PHARMACAL CO INC
DEXBROMPHENIRAMINE MALEATE~SYRUP;ORAL~DISOMER~SCHERING~2MG/5ML~N~011814~002~~App
roved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
OXYBUTYNIN CHLORIDE~SYRUP;ORAL~DITROPAN~ORTHO MCNEIL JANSSEN~5MG/5ML~N~018211~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL JANSSEN PHARMACEUTICALS I
NC
METHADONE HYDROCHLORIDE~SYRUP;ORAL~DOLOPHINE HYDROCHLORIDE~ROXANE~10MG/30ML~N~00
6134~004~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
ETHOSUXIMIDE~SYRUP;ORAL~ETHOSUXIMIDE~MIKART~250MG/5ML~A~040506~001~AA~Dec 22, 20
03~No~RX~MIKART INC
ETHOSUXIMIDE~SYRUP;ORAL~ETHOSUXIMIDE~PHARM ASSOC~250MG/5ML~A~040253~001~AA~Nov 2
2, 2000~No~RX~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
ETHOSUXIMIDE~SYRUP;ORAL~ETHOSUXIMIDE~TEVA PHARMS~250MG/5ML~A~081306~001~AA~Jul 3
RIMANTADINE HYDROCHLORIDE~SYRUP;ORAL~FLUMADINE~FOREST LABS~50MG/5ML~N~019650~001
~~Sep 17, 1993~No~DISCN~FOREST LABORATORIES INC
SULFISOXAZOLE ACETYL~SYRUP;ORAL~GANTRISIN~ROCHE~EQ 500MG BASE/5ML~N~009182~002~~
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~HISTAFED~CE
NCI~30MG/5ML;1.25MG/5ML~A~088283~001~~Apr 20, 1984~No~DISCN~HR CENCI LABORATORIE
S INC
PAROMOMYCIN SULFATE~SYRUP;ORAL~HUMATIN~PARKE DAVIS~EQ 125MG BASE/5ML~A~060522~00
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE~SYRUP;ORAL~HYCODAN~ENDO PHARMS
~1.5MG/5ML;5MG/5ML~N~005213~002~~Jul 26, 1988~No~DISCN~ENDO PHARMACEUTICALS INC
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~HYDRAMINE~ALPHARMA US PHARMS~12.5MG/5ML
~A~070205~001~~Jan 28, 1986~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE~SYRUP;ORAL~HYDROCODONE BITARTR
ATE AND HOMATROPINE METHYLBROMIDE~ACTAVIS MID ATLANTIC~1.5MG/5ML;5MG/5ML~A~08801
7~001~AA~Jul 5, 1983~No~RX~ACTAVIS MID ATLANTIC LLC
ATE AND HOMATROPINE METHYLBROMIDE~HI TECH PHARMA~1.5MG/5ML;5MG/5ML~A~040613~001~
AA~Feb 8, 2008~Yes~RX~HI TECH PHARMACAL CO INC
ATE AND HOMATROPINE METHYLBROMIDE~IVAX SUB TEVA PHARMS~1.5MG/5ML;5MG/5ML~A~04028
5~001~~Jul 19, 1999~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS U
SA
ATE AND HOMATROPINE METHYLBROMIDE~WOCKHARDT~1.5MG/5ML;5MG/5ML~A~088008~001~AA~Ma
r 3, 1983~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE~SYRUP;ORAL~HYDROPANE~HALSEY~1.
5MG/5ML;5MG/5ML~A~088066~001~~Jun 28, 1985~No~DISCN~HALSEY DRUG CO INC
HYDROXYZINE HYDROCHLORIDE~SYRUP;ORAL~HYDROXYZINE HYDROCHLORIDE~ALPHARMA US PHARM
S~10MG/5ML~A~088785~001~~Feb 3, 1988~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISI
ON
HYDROXYZINE HYDROCHLORIDE~SYRUP;ORAL~HYDROXYZINE HYDROCHLORIDE~HI TECH PHARMA~10
MG/5ML~A~040010~001~AA~Oct 28, 1994~Yes~RX~HI TECH PHARMACAL CO INC
HYDROXYZINE HYDROCHLORIDE~SYRUP;ORAL~HYDROXYZINE HYDROCHLORIDE~KV PHARM~10MG/5ML
~A~087730~001~~Jul 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
HYDROXYZINE HYDROCHLORIDE~SYRUP;ORAL~HYDROXYZINE HYDROCHLORIDE~SILARX PHARMS INC
~10MG/5ML~A~201674~001~AA~Aug 21, 2013~No~RX~SILARX PHARMACEUTICALS INC
HYDROXYZINE HYDROCHLORIDE~SYRUP;ORAL~HYDROXYZINE HYDROCHLORIDE~STI PHARMA LLC~10
MG/5ML~A~086880~001~~Approved Prior to Jan 1, 1982~No~DISCN~STI PHARMA LLC
HYDROXYZINE HYDROCHLORIDE~SYRUP;ORAL~HYDROXYZINE HYDROCHLORIDE~VINTAGE PHARMS~10
MG/5ML~A~040391~001~AA~Apr 10, 2002~Yes~RX~VINTAGE PHARMACEUTICALS INC
HYDROXYZINE HYDROCHLORIDE~SYRUP;ORAL~HYDROXYZINE HYDROCHLORIDE~WOCKHARDT~10MG/5M
L~A~087294~001~AA~Apr 12, 1982~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
ISONIAZID~SYRUP;ORAL~ISONIAZID~CAROLINA MEDCL~50MG/5ML~A~088235~001~~Nov 10, 198
3~Yes~RX~CAROLINA MEDICAL PRODUCTS CO
ISONIAZID~SYRUP;ORAL~ISONIAZID~MIKART~50MG/5ML~A~081118~001~~Jul 21, 1997~No~DIS
CN~MIKART INC
TRIAMCINOLONE DIACETATE~SYRUP;ORAL~KENACORT~DELCOR ASSET CORP~EQ 4MG BASE/5ML~N~
ISONIAZID~SYRUP;ORAL~LANIAZID~LANNETT~50MG/5ML~A~089243~001~~Feb 3, 1986~No~DISC
N~LANNETT CO INC
PREDNISONE~SYRUP;ORAL~LIQUID PRED~MURO~5MG/5ML~A~087611~002~~Sep 7, 1982~No~DISC
N~MURO PHARMACEUTICAL INC
LITHIUM CITRATE~SYRUP;ORAL~LITHIUM CITRATE~ROXANE~EQ 300MG CARBONATE/5ML~N~01842
1~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~ROXANE LABORATORIES INC
LITHIUM CITRATE~SYRUP;ORAL~LITHIUM CITRATE~WOCKHARDT~EQ 300MG CARBONATE/5ML~A~07

0755~001~AA~May 21, 1986~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
LITHIUM CITRATE~SYRUP;ORAL~LITHONATE~SOLVAY~EQ 300MG CARBONATE/5ML~N~017672~001~
~Approved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
LORATADINE~SYRUP;ORAL~LORATADINE~APOTEX INC~1MG/ML~A~075565~001~~Oct 5, 2004~No~
DISCN~APOTEX INC
LORATADINE~SYRUP;ORAL~LORATADINE~PERRIGO~1MG/ML~A~075728~001~~Aug 20, 2004~No~OT
C~L PERRIGO CO
LORATADINE~SYRUP;ORAL~LORATADINE~RANBAXY LABS LTD~1MG/ML~A~076529~001~~Aug 20, 2
004~No~DISCN~RANBAXY LABORATORIES LTD
LORATADINE~SYRUP;ORAL~LORATADINE~SILARX~1MG/ML~A~077421~001~~Jun 29, 2006~No~OTC
~SILARX PHARMACEUTICALS INC
LORATADINE~SYRUP;ORAL~LORATADINE~TARO~1MG/ML~A~076805~001~~Aug 20, 2004~No~OTC~T
LORATADINE~SYRUP;ORAL~LORATADINE~TEVA~1MG/ML~A~075505~001~~Nov 7, 2003~No~OTC~TE
LORATADINE~SYRUP;ORAL~LORATADINE~WOCKHARDT~1MG/ML~A~075815~001~~Aug 20, 2004~No~
OTC~WOCKHARDT EU OPERATIONS (SWISS) AG
MEPERIDINE HYDROCHLORIDE~SYRUP;ORAL~MEPERIDINE HYDROCHLORIDE~ROXANE~50MG/5ML~A~0
88744~001~~Jan 30, 1985~Yes~RX~ROXANE LABORATORIES INC
PYRIDOSTIGMINE BROMIDE~SYRUP;ORAL~MESTINON~VALEANT PHARMS~60MG/5ML~N~015193~001~
~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
METAPROTERENOL SULFATE~SYRUP;ORAL~METAPROTERENOL SULFATE~APOTEX INC~10MG/5ML~A~0
75235~001~~Jan 27, 2000~No~DISCN~APOTEX INC
METAPROTERENOL SULFATE~SYRUP;ORAL~METAPROTERENOL SULFATE~MORTON GROVE~10MG/5ML~A
~071656~001~~Oct 13, 1987~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
METAPROTERENOL SULFATE~SYRUP;ORAL~METAPROTERENOL SULFATE~SILARX~10MG/5ML~A~07363
2~001~~Jul 22, 1992~Yes~RX~SILARX PHARMACEUTICALS INC
METAPROTERENOL SULFATE~SYRUP;ORAL~METAPROTERENOL SULFATE~TEVA~10MG/5ML~A~072761~
001~~Feb 27, 1992~No~DISCN~TEVA PHARMACEUTICALS USA INC
METAPROTERENOL SULFATE~SYRUP;ORAL~METAPROTERENOL SULFATE~TEVA PHARMS~10MG/5ML~A~
073034~001~~Aug 30, 1991~No~DISCN~TEVA PHARMACEUTICALS USA
METAPROTERENOL SULFATE~SYRUP;ORAL~METAPROTERENOL SULFATE~WOCKHARDT~10MG/5ML~A~07
4702~001~~Mar 24, 1997~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
METHDILAZINE HYDROCHLORIDE~SYRUP;ORAL~METHDILAZINE HYDROCHLORIDE~ALPHARMA US PHA
RMS~4MG/5ML~A~087122~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHA
RMACEUTICALS DIVISION
MIDAZOLAM HYDROCHLORIDE~SYRUP;ORAL~MIDAZOLAM HYDROCHLORIDE~APOTEX INC~EQ 2MG BAS
E/ML~A~077115~001~~Sep 9, 2005~No~DISCN~APOTEX INC
MIDAZOLAM HYDROCHLORIDE~SYRUP;ORAL~MIDAZOLAM HYDROCHLORIDE~HI TECH PHARMA~EQ 2MG
BASE/ML~A~075958~001~AA~Sep 4, 2003~No~RX~HI TECH PHARMACAL CO INC
MIDAZOLAM HYDROCHLORIDE~SYRUP;ORAL~MIDAZOLAM HYDROCHLORIDE~PADDOCK LLC~EQ 2MG BA
SE/ML~A~076379~001~AA~May 2, 2005~No~RX~PADDOCK LABORATORIES LLC
MIDAZOLAM HYDROCHLORIDE~SYRUP;ORAL~MIDAZOLAM HYDROCHLORIDE~RANBAXY~EQ 2MG BASE/M
L~A~076058~001~AA~Mar 15, 2002~No~RX~RANBAXY LABORATORIES LTD
MIDAZOLAM HYDROCHLORIDE~SYRUP;ORAL~MIDAZOLAM HYDROCHLORIDE~ROXANE~EQ 2MG BASE/ML
~A~075873~001~AA~Apr 30, 2002~Yes~RX~ROXANE LABORATORIES INC
PIPERAZINE CITRATE~SYRUP;ORAL~MULTIFUGE~BLULINE~EQ 500MG BASE/5ML~N~009452~001~~
Approved Prior to Jan 1, 1982~No~DISCN~BLULINE LABORATORIES INC
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~MYFED~USL P
HARMA~30MG/5ML;1.25MG/5ML~A~088116~001~~Mar 4, 1983~No~DISCN~USL PHARMA INC
TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~MYIDYL~USL PHARMA~1.25MG/5ML~A~087963~001~
~Jan 18, 1983~No~DISCN~USL PHARMA INC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~MYMETHAZINE FORTIS~USL PHARMA~25MG/5ML~A~0
87996~001~~Jan 18, 1983~No~DISCN~USL PHARMA INC
OXTRIPHYLLINE~SYRUP;ORAL~OXTRIPHYLLINE PEDIATRIC~MORTON GROVE~50MG/5ML~A~088242~
001~~Dec 5, 1983~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~SYRUP;ORAL~OXYBUTYNIN CHLORIDE~APOTEX INC~5MG/5ML~A~074997~0
01~~Oct 15, 1997~No~DISCN~APOTEX INC
OXYBUTYNIN CHLORIDE~SYRUP;ORAL~OXYBUTYNIN CHLORIDE~MIKART~5MG/5ML~A~075039~001~~
Jan 29, 1999~No~DISCN~MIKART INC

OXYBUTYNIN CHLORIDE~SYRUP;ORAL~OXYBUTYNIN CHLORIDE~PHARM ASSOC~5MG/5ML~A~075137~
001~AA~Dec 18, 1998~No~RX~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
OXYBUTYNIN CHLORIDE~SYRUP;ORAL~OXYBUTYNIN CHLORIDE~SILARX~5MG/5ML~A~074520~001~A
A~Mar 29, 1996~No~RX~SILARX PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~SYRUP;ORAL~OXYBUTYNIN CHLORIDE~VINTAGE PHARMS~5MG/5ML~A~0766
82~001~AA~Dec 28, 2004~No~RX~VINTAGE PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~SYRUP;ORAL~OXYBUTYNIN CHLORIDE~WOCKHARDT~5MG/5ML~A~074868~00
1~AA~Feb 12, 1997~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
CYPROHEPTADINE HYDROCHLORIDE~SYRUP;ORAL~PERIACTIN~MERCK~2MG/5ML~N~013220~002~~Ap
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PHENERGAN VC~
ANI PHARMS~5MG/5ML;6.25MG/5ML~N~008604~003~~Apr 2, 1984~No~DISCN~ANI PHARMACEUTI
CALS INC
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP
;ORAL~PHENERGAN VC W/ CODEINE~ANI PHARMS~10MG/5ML;5MG/5ML;6.25MG/5ML~N~008306~00
5~~Apr 2, 1984~No~DISCN~ANI PHARMACEUTICALS INC
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PHENERGAN W/ CODEINE~AN
I PHARMS~10MG/5ML;6.25MG/5ML~N~008306~004~~Apr 2, 1984~No~DISCN~ANI PHARMACEUTIC
ALS INC
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PHENYLEPHRINE
HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE~HI-TECH PHARMACAL~5MG/5ML;6.25MG/5
ML~A~040675~001~AA~Dec 23, 2014~No~RX~HI-TECH PHARMACAL CO INC
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PHENYLEPHRINE
HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE~VINTAGE~5MG/5ML;6.25MG/5ML~A~04065
4~001~AA~Dec 7, 2006~No~RX~VINTAGE PHARMACEUTICALS LLC
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PHERAZINE D
M~HALSEY~15MG/5ML;6.25MG/5ML~A~088913~001~~Mar 2, 1987~No~DISCN~HALSEY DRUG CO I
NC
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PHERAZINE VC~
HALSEY~5MG/5ML;6.25MG/5ML~A~088868~001~~Mar 2, 1987~No~DISCN~HALSEY DRUG CO INC
;ORAL~PHERAZINE VC W/ CODEINE~HALSEY~10MG/5ML;5MG/5ML;6.25MG/5ML~A~088870~001~~M
ar 2, 1987~No~DISCN~HALSEY DRUG CO INC
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PHERAZINE W/ CODEINE~HA
LSEY~10MG/5ML;6.25MG/5ML~A~088739~001~~Dec 23, 1988~No~DISCN~HALSEY DRUG CO INC
PIPERAZINE CITRATE~SYRUP;ORAL~PIPERAZINE CITRATE~ALPHARMA US PHARMS~EQ 500MG BAS
E/5ML~A~080774~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACEU
TICALS DIVISION
PIPERAZINE CITRATE~SYRUP;ORAL~PIPERAZINE CITRATE~LANNETT~EQ 500MG BASE/5ML~A~080
963~001~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
PIPERAZINE CITRATE~SYRUP;ORAL~PIPERAZINE CITRATE~LUITPOLD~EQ 500MG BASE/5ML~A~08
DEXCHLORPHENIRAMINE MALEATE~SYRUP;ORAL~POLARAMINE~SCHERING~2MG/5ML~A~086837~001~
~Jul 19, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~ALPHARMA~15MG/5ML~A~040323~001~AA~May 13, 1
999~No~RX~ALPHARMA USPD INC
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~APOTEX INC~5MG/5ML~A~040570~001~~Aug 25, 20
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~APOTEX INC~15MG/5ML~A~040571~001~~Aug 25, 2
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~HI TECH PHARMA CO~15MG/5ML~A~040401~001~AA~
Feb 27, 2003~Yes~RX~HI TECH PHARMACAL CO INC
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~IVAX SUB TEVA PHARMS~15MG/5ML~A~040287~001~
~May 28, 1999~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~NESHER PHARMS~5MG/5ML~A~040423~001~~Oct 22,
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~NESHER PHARMS~15MG/5ML~A~040364~001~~Apr 10
, 2002~No~DISCN~NESHER PHARMACEUTICALS USA LLC
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~PHARM ASSOC~15MG/5ML~A~040399~001~AA~Mar 5,
2003~No~RX~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS

PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~TEVA PHARMS~15MG/5ML~A~040322~001~~Jan 19,
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~VINTAGE~15MG/5ML~A~040775~001~AA~Sep 21, 20
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~WE PHARMS~15MG/5ML~A~040192~001~~May 28, 19
98~No~DISCN~WE PHARMACEUTICALS INC
PREDNISOLONE~SYRUP;ORAL~PREDNISOLONE~WOCKHARDT~15MG/5ML~A~040313~001~AA~Sep 10,
PREDNISOLONE~SYRUP;ORAL~PRELONE~MURO~5MG/5ML~A~089654~001~~Jan 17, 1989~No~DISCN
~MURO PHARMACEUTICAL INC
PREDNISOLONE~SYRUP;ORAL~PRELONE~TEVA~15MG/5ML~A~089081~001~AA~Feb 4, 1986~No~RX~
PROCHLORPERAZINE EDISYLATE~SYRUP;ORAL~PROCHLORPERAZINE EDISYLATE~ALPHARMA US PHA
RMS~EQ 5MG BASE/5ML~A~087154~001~~Sep 1, 1982~No~DISCN~ALPHARMA US PHARMACEUTICA
LS DIVISION
PROCHLORPERAZINE EDISYLATE~SYRUP;ORAL~PROCHLORPERAZINE EDISYLATE~MORTON GROVE~EQ
5MG BASE/5ML~A~088597~001~~Oct 25, 1984~No~DISCN~MORTON GROVE PHARMACEUTICALS I
NC
METAPROTERENOL SULFATE~SYRUP;ORAL~PROMETA~MURO~10MG/5ML~A~072023~001~~Sep 15, 19
88~No~DISCN~MURO PHARMACEUTICAL INC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETH FORTIS~ALPHARMA US PHARMS~25MG/5ML
~A~084772~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACEUTICAL
S DIVISION
;ORAL~PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE~VINT
AGE~10MG/5ML;5MG/5ML;6.25MG/5ML~A~040660~001~AA~Dec 7, 2006~No~RX~VINTAGE PHARMA
CEUTICALS LLC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETH PLAIN~ACTAVIS MID ATLANTIC~6.25MG/
5ML~A~085953~001~~Approved Prior to Jan 1, 1982~No~DISCN~ACTAVIS MID ATLANTIC LL
C
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETH VC PL
AIN~ACTAVIS MID ATLANTIC~5MG/5ML;6.25MG/5ML~A~088761~001~AA~Nov 8, 1984~Yes~RX~A
CTAVIS MID ATLANTIC LLC
;ORAL~PROMETH VC W/ CODEINE~ACTAVIS MID ATLANTIC~10MG/5ML;5MG/5ML;6.25MG/5ML~A~0
88764~001~AA~Oct 31, 1984~Yes~RX~ACTAVIS MID ATLANTIC LLC
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETH W/
DEXTROMETHORPHAN~ACTAVIS MID ATLANTIC~15MG/5ML;6.25MG/5ML~A~088762~001~~Oct 31,
1984~No~DISCN~ACTAVIS MID ATLANTIC LLC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE~CENCI~6.25MG/5ML~A~089013~001
~~Sep 20, 1985~No~DISCN~HR CENCI LABORATORIES INC
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZIN
E DM~VINTAGE~15MG/5ML;6.25MG/5ML~A~040649~001~AA~Feb 14, 2006~Yes~RX~VINTAGE PHA
RMACEUTICALS LLC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~AMNEAL PHARMS~6
.25MG/5ML~A~040882~001~AA~Dec 30, 2009~No~RX~AMNEAL PHARMACEUTICALS
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~HI TECH PHARMA~
6.25MG/5ML~A~040026~001~AA~Sep 25, 1998~No~RX~HI TECH PHARMACAL CO INC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~KV PHARM~6.25MG
/5ML~A~085388~001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~KV PHARM~25MG/5
ML~A~085385~001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~PHARM ASSOC~6.2
5MG/5ML~A~087518~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL ASSO
C INC DIV BEACH PRODUCTS
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~SUN PHARM INDS
INC~6.25MG/5ML~A~040891~001~AA~Mar 13, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES
INC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~TARO~6.25MG/5ML
~A~040718~001~AA~Apr 4, 2007~No~RX~TARO PHARMACEUTICALS USA INC

PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~TRIS PHARMA INC
~6.25MG/5ML~A~091675~001~AA~Jun 28, 2012~No~RX~TRIS PHARMA INC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~VINTAGE~6.25MG/
5ML~A~040643~001~AA~Apr 26, 2006~No~RX~VINTAGE PHARMACEUTICALS LLC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE~WHITEWORTH TOWN
PLSN~6.25MG/5ML~A~086395~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH
TOWNE PAULSEN INC
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLOR
IDE AND CODEINE PHOSPHATE~ACTAVIS MID ATLANTIC~10MG/5ML;6.25MG/5ML~A~088763~001~
AA~Oct 31, 1984~Yes~RX~ACTAVIS MID ATLANTIC LLC
IDE AND CODEINE PHOSPHATE~AMNEAL PHARMS~10MG/5ML;6.25MG/5ML~A~200894~001~AA~Apr
IDE AND CODEINE PHOSPHATE~HI TECH PHARMA~10MG/5ML;6.25MG/5ML~A~040151~001~AA~Aug
IDE AND CODEINE PHOSPHATE~PHARM ASSOC~10MG/5ML;6.25MG/5ML~A~089647~001~~Dec 22,
1988~No~DISCN~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
IDE AND CODEINE PHOSPHATE~SUN PHARM INDS INC~10MG/5ML;6.25MG/5ML~A~090180~001~AA
~Mar 17, 2010~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
IDE AND CODEINE PHOSPHATE~TRIS PHARMA INC~10MG/5ML;6.25MG/5ML~A~200386~001~AA~Ju
n 29, 2012~No~RX~TRIS PHARMA INC
IDE AND CODEINE PHOSPHATE~WOCKHARDT~10MG/5ML;6.25MG/5ML~A~088875~001~AA~Dec 17,
E HYDROCHLORIDE AND DESTROMETHORPHAN HYDROBROMIDE~ANI PHARMS~15MG/5ML;6.25MG/5ML
~N~011265~002~~Apr 2, 1984~No~DISCN~ANI PHARMACEUTICALS INC
E HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE~AMNEAL PHARMS~15MG/5ML;6.25MG/
5ML~A~090575~001~~Feb 8, 2011~No~DISCN~AMNEAL PHARMACEUTICALS
E HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE~HI TECH PHARMA~15MG/5ML;6.25MG
/5ML~A~040027~001~AA~Jul 31, 1996~No~RX~HI TECH PHARMACAL CO INC
E HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE~TRIS PHARMA INC~15MG/5ML;6.25M
G/5ML~A~091687~001~~Jun 28, 2012~No~DISCN~TRIS PHARMA INC
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE
HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE~AMNEAL PHARMS~5MG/5ML;6.25MG/5ML~A
~040902~001~AA~Aug 25, 2009~No~RX~AMNEAL PHARMACEUTICALS
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE PLAIN~ANI PHARM
S~6.25MG/5ML~N~008381~004~~Apr 18, 1984~No~DISCN~ANI PHARMACEUTICALS INC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE HYDROCHLORIDE PLAIN~ANI PHARM
S~25MG/5ML **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons**~N~008381~003~~Approved Prior to Jan
1, 1982~No~DISCN~ANI PHARMACEUTICALS INC
;ORAL~PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHAT
E~HI-TECH PHARMA CO~10MG/5ML;5MG/5ML;6.25MG/5ML~A~040674~001~AA~Dec 23, 2014~No~
RX~HI-TECH PHARMACAL CO INC
PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE PLAIN~WOCKHARDT~6.25MG/5ML~A~
087953~001~AA~Nov 15, 1982~Yes~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
VC PLAIN~CENCI~5MG/5ML;6.25MG/5ML~A~088815~001~~Nov 22, 1985~No~DISCN~HR CENCI L
ABORATORIES INC
VC PLAIN~WOCKHARDT~5MG/5ML;6.25MG/5ML~A~088897~001~~Jan 4, 1985~No~DISCN~WOCKHAR
DT EU OPERATIONS (SWISS) AG
;ORAL~PROMETHAZINE VC W/ CODEINE~CENCI~10MG/5ML;5MG/5ML;6.25MG/5ML~A~088816~001~
~Nov 22, 1985~No~DISCN~HR CENCI LABORATORIES INC
;ORAL~PROMETHAZINE VC W/ CODEINE~WOCKHARDT~10MG/5ML;5MG/5ML;6.25MG/5ML~A~088896~
001~~Jan 4, 1985~No~DISCN~WOCKHARDT EU OPERATIONS (SWISS) AG
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE W/ CODEINE
~CENCI~10MG/5ML;6.25MG/5ML~A~088814~001~~Nov 22, 1985~No~DISCN~HR CENCI LABORATO
RIES INC
E W/ DEXTROMETHORPHAN~WOCKHARDT~15MG/5ML;6.25MG/5ML~A~088864~001~AA~Jan 4, 1985~
No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE~SYRUP;ORAL~PROMETHAZINE WITH CODEI
NE~VINTAGE~10MG/5ML;6.25MG/5ML~A~040650~001~AA~Jan 31, 2006~No~RX~VINTAGE PHARMA
CEUTICALS LLC
ALBUTEROL SULFATE~SYRUP;ORAL~PROVENTIL~SCHERING~EQ 2MG BASE/5ML~N~018062~001~~Ja
n 19, 1983~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~ACTAVIS MID ATLANTI
C~EQ 15MG BASE/ML~A~076124~001~AA~Feb 21, 2007~No~RX~ACTAVIS MID ATLANTIC LLC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~AMNEAL PHARMS~EQ 15
MG BASE/ML~A~078312~001~AA~Sep 2, 2008~No~RX~AMNEAL PHARMACEUTICALS
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~APOTEX INC~EQ 15MG
BASE/ML~A~077602~001~~Sep 17, 2007~No~DISCN~APOTEX INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~AUROBINDO PHARM~EQ
15MG BASE/ML~A~090623~001~AA~Jul 28, 2010~No~RX~AUROBINDO PHARMA USA INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~BIO PHARM INC~EQ 15
MG BASE/ML~A~090102~001~AA~May 26, 2009~No~RX~BIO PHARM INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~BRECKENRIDGE PHARM~
EQ 15MG BASE/ML~A~078684~001~AA~Aug 27, 2009~No~RX~BRECKENRIDGE PHARMACEUTICAL I
NC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~CARACO~EQ 15MG BASE
/ML~A~091091~001~AA~Sep 20, 2011~No~RX~CARACO PHARMACEUTICAL LABORATORIES LTD
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~HI TECH PHARMA~EQ 1
5MG BASE/ML~A~091078~001~AA~Mar 22, 2011~No~RX~HI TECH PHARMACAL CO INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~PHARM ASSOC~EQ 15MG
BASE/ML~A~077405~001~AA~Sep 21, 2007~No~RX~PHARMACEUTICAL ASSOC INC DIV BEACH P
RODUCTS
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~RANBAXY~EQ 15MG BAS
E/ML~A~078448~001~~Dec 13, 2007~No~DISCN~RANBAXY INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~SILARX~EQ 15MG BASE
/ML~A~091288~001~AA~Dec 9, 2010~No~RX~SILARX PHARMACEUTICALS INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~TARO~EQ 15MG BASE/M
L~A~077476~001~AA~Jun 13, 2011~No~RX~TARO PHARMACEUTICALS USA INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~TOLMAR~EQ 15MG BASE
/ML~A~090054~001~AA~Nov 15, 2010~No~RX~TOLMAR INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~VINTAGE PHARMS~EQ 1
5MG BASE/ML~A~078890~001~AA~Jul 1, 2010~No~RX~VINTAGE PHARMACEUTICALS INC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~WOCKHARDT~EQ 15MG B
ASE/ML~A~079211~001~AA~May 26, 2009~No~RX~WOCKHARDT LTD
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~RANITIDINE HYDROCHLORIDE~WOCKHARDT~EQ 15MG B
ASE/ML~A~079212~001~AA~Feb 23, 2009~No~RX~WOCKHARDT LTD
ZIDOVUDINE~SYRUP;ORAL~RETROVIR~VIIV HLTHCARE~50MG/5ML~N~019910~001~AA~Sep 28, 19
ISONIAZID~SYRUP;ORAL~RIMIFON~ROCHE~50MG/5ML~N~008420~001~~Approved Prior to Jan
METHACYCLINE HYDROCHLORIDE~SYRUP;ORAL~RONDOMYCIN~MEDPOINTE PHARM HLC~EQ 70MG BAS
E/5ML~A~060641~003~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTI
CALS MEDPOINTE HEALTHCARE INC
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~SILPHEN~SILARX~12.5MG/5ML~A~072646~001~
~Feb 27, 1992~No~DISCN~SILARX PHARMACEUTICALS INC
THEOPHYLLINE~SYRUP;ORAL~SLO-PHYLLIN~SANOFI AVENTIS US~80MG/15ML~A~085187~001~~Ap
CHLORPROMAZINE HYDROCHLORIDE~SYRUP;ORAL~SONAZINE~SANDOZ~10MG/5ML~A~083040~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
PROMAZINE HYDROCHLORIDE~SYRUP;ORAL~SPARINE~WYETH AYERST~10MG/5ML~N~010942~003~~A
pproved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
AMANTADINE HYDROCHLORIDE~SYRUP;ORAL~SYMMETREL~ENDO PHARMS~50MG/5ML~N~016023~002~
~Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUTICALS INC
METHDILAZINE HYDROCHLORIDE~SYRUP;ORAL~TACARYL~WESTWOOD SQUIBB~4MG/5ML~N~011950~0
07~~Approved Prior to Jan 1, 1982~No~DISCN~WESTWOOD SQUIBB PHARMACEUTICALS INC
CLEMASTINE FUMARATE~SYRUP;ORAL~TAVIST~NOVARTIS~EQ 0.5MG BASE/5ML~N~018675~001~~J
un 28, 1985~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
TRIMEPRAZINE TARTRATE~SYRUP;ORAL~TEMARIL~ALLERGAN HERBERT~EQ 2.5MG BASE/5ML~N~01
1316~003~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN HERBERT SKIN CARE DIV
ALLERGAN INC
OXYTETRACYCLINE CALCIUM~SYRUP;ORAL~TERRAMYCIN~PFIZER~EQ 125MG BASE/5ML~A~060595~
THEOPHYLLINE~SYRUP;ORAL~THEOCLEAR-80~CENT PHARMS~80MG/15ML~A~087095~001~~Mar 1,
1982~No~DISCN~CENTRAL PHARMACEUTICALS INC
THEOPHYLLINE~SYRUP;ORAL~THEOPHYLLINE~ALPHARMA US PHARMS~80MG/15ML~A~086001~001~~
Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
THEOPHYLLINE~SYRUP;ORAL~THEOPHYLLINE~ALPHARMA US PHARMS~150MG/15ML~A~086545~001~
~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVISION
CHLORPROMAZINE HYDROCHLORIDE~SYRUP;ORAL~THORAZINE~GLAXOSMITHKLINE~10MG/5ML **Fed
~GLAXOSMITHKLINE
UP;ORAL~TRIACIN-C~STI PHARMA LLC~10MG/5ML;30MG/5ML;1.25MG/5ML~A~088704~001~~Mar
22, 1985~Yes~RX~STI PHARMA LLC
PERPHENAZINE~SYRUP;ORAL~TRILAFON~SCHERING~2MG/5ML~N~011294~002~~Approved Prior t
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~TRILITRON~N
EWTRON PHARMS~30MG/5ML;1.25MG/5ML~A~088474~001~~Feb 12, 1985~No~DISCN~NEWTRON PH
ARMACEUTICALS INC
TRIMEPRAZINE TARTRATE~SYRUP;ORAL~TRIMEPRAZINE TARTRATE~ALPHARMA US PHARMS~EQ 2.5
MG BASE/5ML~A~085015~001~~Feb 18, 1982~No~DISCN~ALPHARMA US PHARMACEUTICALS DIVI
SION
TRIMEPRAZINE TARTRATE~SYRUP;ORAL~TRIMEPRAZINE TARTRATE~MORTON GROVE~EQ 2.5MG BAS
E/5ML~A~088285~001~~Apr 11, 1985~No~DISCN~MORTON GROVE PHARMACEUTICALS INC
UP;ORAL~TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE~CENCI~10MG/5M
L;30MG/5ML;1.25MG/5ML~A~089018~001~~Jul 23, 1986~No~DISCN~HR CENCI LABORATORIES
INC
UP;ORAL~TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE~WOCKHARDT~10
MG/5ML;30MG/5ML;1.25MG/5ML~A~088833~001~~Nov 16, 1984~No~DISCN~WOCKHARDT EU OPER
ATIONS (SWISS) AG
TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~TRIPROLIDINE HYDROCHLORIDE~ALPHARMA US PHA
RMS~1.25MG/5ML~A~085940~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALPHARMA US
PHARMACEUTICALS DIVISION
TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~TRIPROLIDINE HYDROCHLORIDE~HALSEY~1.25MG/5
ML~A~088735~001~~Jan 17, 1985~No~DISCN~HALSEY DRUG CO INC
TRIPROLIDINE HYDROCHLORIDE~SYRUP;ORAL~TRIPROLIDINE HYDROCHLORIDE~PHARM ASSOC~1.2
5MG/5ML~A~087514~001~~Feb 10, 1982~No~DISCN~PHARMACEUTICAL ASSOC INC DIV BEACH P
RODUCTS
CHLOPHEDIANOL HYDROCHLORIDE~SYRUP;ORAL~ULO~3M~25MG/5ML~N~012126~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
VALPROIC ACID~SYRUP;ORAL~VALPROIC ACID~ALPHARMA~250MG/5ML~A~075782~001~AA~Dec 22

, 2000~No~RX~ALPHARMA USPD INC
VALPROIC ACID~SYRUP;ORAL~VALPROIC ACID~ANI PHARMS INC~250MG/5ML~A~073178~001~AA~
Aug 25, 1992~No~RX~ANI PHARMACEUTICALS INC
VALPROIC ACID~SYRUP;ORAL~VALPROIC ACID~APOTEX INC~250MG/5ML~A~077105~001~~Jul 29
, 2005~No~DISCN~APOTEX INC RICHMOND HILL
VALPROIC ACID~SYRUP;ORAL~VALPROIC ACID~HIGH TECH PHARMA~250MG/5ML~A~074060~001~A
A~Jan 13, 1995~No~RX~HIGH TECHNOLOGY PHARMACAL CO INC
VALPROIC ACID~SYRUP;ORAL~VALPROIC ACID~PHARM ASSOC~250MG/5ML~A~075379~001~AA~Dec
15, 2000~No~RX~PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
VALPROIC ACID~SYRUP;ORAL~VALPROIC ACID~SUN PHARM INDS INC~250MG/5ML~A~090517~001
~AA~May 28, 2010~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
VALPROIC ACID~SYRUP;ORAL~VALPROIC ACID~VINTAGE~250MG/5ML~A~077960~001~AA~Oct 13,
VALPROIC ACID~SYRUP;ORAL~VALPROIC ACID~WOCKHARDT~250MG/5ML~A~070868~001~AA~Jul 1
, 1986~No~RX~WOCKHARDT EU OPERATIONS (SWISS) AG
ALBUTEROL SULFATE~SYRUP;ORAL~VENTOLIN~GLAXOSMITHKLINE~EQ 2MG BASE/5ML~N~019621~0
01~~Jun 10, 1987~No~DISCN~GLAXOSMITHKLINE
PIPERAZINE CITRATE~SYRUP;ORAL~VERMIDOL~SOLVAY~EQ 500MG BASE/5ML~A~080992~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
MIDAZOLAM HYDROCHLORIDE~SYRUP;ORAL~VERSED~ROCHE~EQ 2MG BASE/ML~N~020942~001~~Oct
DIPHENHYDRAMINE HYDROCHLORIDE~SYRUP;ORAL~VICKS FORMULA 44~WARNER CHILCOTT~12.5MG
/5ML~A~070524~001~~Jan 14, 1987~No~DISCN~WARNER CHILCOTT CO LLC
RANITIDINE HYDROCHLORIDE~SYRUP;ORAL~ZANTAC~GLAXO GRP LTD~EQ 15MG BASE/ML~N~01967
5~001~AA~Dec 30, 1988~Yes~RX~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
ETHOSUXIMIDE~SYRUP;ORAL~ZARONTIN~PARKE DAVIS~250MG/5ML~A~080258~001~AA~Approved
Prior to Jan 1, 1982~Yes~RX~PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBE
RT CO
ZIDOVUDINE~SYRUP;ORAL~ZIDOVUDINE~AUROBINDO~50MG/5ML~A~077268~001~AA~Sep 19, 2005
ZIDOVUDINE~SYRUP;ORAL~ZIDOVUDINE~CIPLA LTD~50MG/5ML~A~077981~001~AA~Jun 26, 2008
~No~RX~CIPLA LTD
CETIRIZINE HYDROCHLORIDE~SYRUP;ORAL~ZYRTEC~MCNEIL CONSUMER~5MG/5ML~N~020346~001~
AA~Sep 27, 1996~Yes~RX~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
DOXYCYCLINE HYCLATE~SYSTEM, EXTENDED RELEASE;PERIODONTAL~ATRIDOX~TOLMAR~50MG~N~0
50751~001~~Sep 3, 1998~Yes~RX~TOLMAR INC
LIDOCAINE HYDROCHLORIDE~SYSTEM;INTRADERMAL~ZINGO~POWDER PHARMS~0.5MG~N~022114~00
1~~Aug 16, 2007~No~RX~POWDER PHARMACEUTICALS INC
SUMATRIPTAN SUCCINATE~SYSTEM;IONTOPHORESIS~ZECUITY~TEVA BRANDED PHARM~EQ 6.5MG B
ASE/4HR~N~202278~001~~Jan 17, 2013~Yes~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R
AND D INC
FENTANYL HYDROCHLORIDE~SYSTEM;IONTOPHORESIS, TRANSDERMAL~IONSYS~INCLINE THERAP~1
0.8MCG~N~021338~001~~May 22, 2006~No~DISCN~INCLINE THERAPEUTICS INC
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE~TABLET, CHEWABL
E, TABLET, CAPSULE;ORAL~HELIDAC~PROMETHEUS LABS~262.4MG,N/A,N/A;N/A,250MG,N/A;N/
A,N/A,500MG~N~050719~001~~Aug 15, 1996~No~DISCN~PROMETHEUS LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET, CHEWABLE, TABLET;ORAL~LO MINAST
RIN FE~WARNER CHILCOTT~0.01MG,0.01MG,N/A;1MG,N/A,N/A~N~204654~001~~Jul 24, 2013~
Yes~RX~WARNER CHILCOTT CO LLC
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE~TABLET, CHEWABLE;ORAL~ALUMINUM HYDROXI
DE AND MAGNESIUM TRISILICATE~PENNEX~80MG;20MG~A~089449~001~~Nov 27, 1987~No~DISC
N~PENNEX PRODUCTS CO INC
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~APOTHECON~125MG~A~064131~001~~May
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~APOTHECON~250MG~A~064131~002~~May
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~DAVA PHARMS INC~125MG~A~064139~001
~~Jan 29, 1996~No~DISCN~DAVA PHARMACEUTICALS INC
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~DAVA PHARMS INC~250MG~A~064139~002
~~Jan 29, 1996~No~DISCN~DAVA PHARMACEUTICALS INC

AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~RANBAXY~125MG~A~065021~001~AB~Dec
23, 1999~No~RX~RANBAXY PHARMACEUTICALS INC
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~RANBAXY~200MG~A~065060~001~~Nov 29
, 2000~No~DISCN~RANBAXY INC
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~RANBAXY~250MG~A~065021~002~AB~Dec
23, 1999~No~RX~RANBAXY PHARMACEUTICALS INC
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~RANBAXY~400MG~A~065060~002~~Nov 29
, 2000~No~DISCN~RANBAXY INC
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~TEVA~125MG~A~064013~002~AB~Sep 11,
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~TEVA~125MG~A~064031~001~~Dec 19, 1
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~TEVA~250MG~A~064013~001~AB~Dec 22,
1992~Yes~RX~TEVA PHARMACEUTICALS USA INC
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXICILLIN~TEVA~250MG~A~064031~002~~Dec 19, 1
AMOXICILLIN; CLAVULANATE POTASSIUM~TABLET, CHEWABLE;ORAL~AMOXICILLIN AND CLAVULA
NATE POTASSIUM~RANBAXY~200MG;EQ 28.5MG BASE~A~065161~001~AB~Dec 3, 2003~No~RX~RA
NBAXY LABORATORIES LTD
NATE POTASSIUM~RANBAXY~400MG;EQ 57MG BASE~A~065161~002~AB~Dec 3, 2003~No~RX~RANB
AXY LABORATORIES LTD
NATE POTASSIUM~SANDOZ~200MG;EQ 28.5MG BASE~A~065065~001~AB~Apr 18, 2002~No~RX~SA
NDOZ INC
NATE POTASSIUM~SANDOZ~400MG;EQ 57MG BASE~A~065065~002~AB~Apr 18, 2002~No~RX~SAND
OZ INC
NATE POTASSIUM~TEVA~200MG;EQ 28.5MG BASE~A~065205~001~AB~Feb 9, 2005~No~RX~TEVA
NATE POTASSIUM~TEVA~400MG;EQ 57MG BASE~A~065205~002~AB~Feb 9, 2005~Yes~RX~TEVA P
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXIL~DR REDDYS LABS INC~125MG~N~050542~002~A
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXIL~DR REDDYS LABS INC~200MG~N~050761~001~~
Apr 15, 1999~No~DISCN~DR REDDYS LABORATORIES INC
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXIL~DR REDDYS LABS INC~250MG~N~050542~001~A
AMOXICILLIN~TABLET, CHEWABLE;ORAL~AMOXIL~DR REDDYS LABS INC~400MG~N~050761~002~~
Apr 15, 1999~No~DISCN~DR REDDYS LABORATORIES INC
MECLIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~ANTIVERT~CITRON PHARMA LLC~25MG~N~
010721~005~~Approved Prior to Jan 1, 1982~No~DISCN~CITRON PHARMA LLC
AMOXICILLIN; CLAVULANATE POTASSIUM~TABLET, CHEWABLE;ORAL~AUGMENTIN '125'~DR REDD
YS LABS INC~125MG;EQ 31.25MG BASE~N~050597~001~AB~Jul 22, 1985~No~RX~DR REDDYS L
ABORATORIES INC
YS LABS INC~200MG;EQ 28.5MG BASE~N~050726~001~AB~May 31, 1996~No~RX~DR REDDYS LA
BORATORIES INC
YS LABS INC~250MG;EQ 62.5MG BASE~N~050597~002~AB~Jul 22, 1985~No~RX~DR REDDYS LA
BORATORIES INC
YS LABS INC~400MG;EQ 57MG BASE~N~050726~002~AB~May 31, 1996~No~RX~DR REDDYS LABO
RATORIES INC
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE~TABLET, CHEWABLE;ORAL~CALCIUM
CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE~PERRIGO R AND D~800MG;10MG;165MG~
A~077355~001~~Feb 6, 2008~No~OTC~PERRIGO R AND D CO
CARBAMAZEPINE~TABLET, CHEWABLE;ORAL~CARBAMAZEPINE~JUBILANT CADISTA~100MG~A~07194

0~001~~Feb 1, 1988~No~DISCN~JUBILANT CADISTA PHARMACEUTICALS INC
CARBAMAZEPINE~TABLET, CHEWABLE;ORAL~CARBAMAZEPINE~TARO PHARM INDS~100MG~A~075687
~001~AB~Oct 24, 2000~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
CARBAMAZEPINE~TABLET, CHEWABLE;ORAL~CARBAMAZEPINE~TARO PHARM INDS~200MG~A~075687
~002~~Jul 29, 2002~Yes~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
CARBAMAZEPINE~TABLET, CHEWABLE;ORAL~CARBAMAZEPINE~TORRENT PHARMS~100MG~A~075712~
001~AB~Jul 5, 2001~No~RX~TORRENT PHARMACEUTICALS LTD
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~
SUN PHARM INDS INC~5MG~A~077631~004~~Jan 11, 2008~No~DISCN~SUN PHARMACEUTICAL IN
DUSTRIES INC
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~
SUN PHARM INDS INC~10MG~A~077631~003~~Jan 11, 2008~No~DISCN~SUN PHARMACEUTICAL I
NDUSTRIES INC
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RE
LIEF~SUN PHARM INDS INC~5MG~A~077631~001~~Jan 11, 2008~No~DISCN~SUN PHARMACEUTIC
AL INDUSTRIES INC
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RE
LIEF~SUN PHARM INDS INC~10MG~A~077631~002~~Jan 11, 2008~No~DISCN~SUN PHARMACEUTI
CAL INDUSTRIES INC
IBUPROFEN~TABLET, CHEWABLE;ORAL~CHILDREN'S ADVIL~PFIZER~50MG~N~020944~001~~Dec 1
8, 1998~No~OTC~PFIZER INC
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CHILDREN'S CETIRIZINE HYDROCHLORI
DE ALLERGY~JUBILANT GENERICS~5MG~A~091116~001~~Feb 19, 2015~No~OTC~JUBILANT GENE
RICS LTD
DE ALLERGY~JUBILANT GENERICS~10MG~A~091116~002~~Feb 19, 2015~No~OTC~JUBILANT GEN
ERICS LTD
DE ALLERGY~SANDOZ~5MG~A~078692~001~~Feb 14, 2008~No~OTC~SANDOZ INC
DE ALLERGY~SANDOZ~10MG~A~078692~002~~Feb 14, 2008~Yes~OTC~SANDOZ INC
DE ALLERGY~SUN PHARMA GLOBAL~5MG~A~090142~001~~Aug 30, 2011~No~OTC~SUN PHARMA GL
OBAL FZE
DE ALLERGY~SUN PHARMA GLOBAL~10MG~A~090142~002~~Aug 30, 2011~No~OTC~SUN PHARMA G
LOBAL FZE
DE HIVES RELIEF~JUBILANT GENERICS~5MG~A~091116~003~~Feb 19, 2015~No~OTC~JUBILANT
GENERICS LTD
DE HIVES RELIEF~JUBILANT GENERICS~10MG~A~091116~004~~Feb 19, 2015~No~OTC~JUBILAN
T GENERICS LTD
DE HIVES RELIEF~SUN PHARMA GLOBAL~5MG~A~090142~003~~Aug 30, 2011~No~OTC~SUN PHAR
MA GLOBAL FZE
DE HIVES RELIEF~SUN PHARMA GLOBAL~10MG~A~090142~004~~Aug 30, 2011~No~OTC~SUN PHA
RMA GLOBAL FZE
LORATADINE~TABLET, CHEWABLE;ORAL~CHILDREN'S CLARITIN~SCHERING PLOUGH~5MG~N~02189
1~001~~Aug 23, 2006~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
IBUPROFEN~TABLET, CHEWABLE;ORAL~CHILDREN'S MOTRIN~MCNEIL CONS~50MG~N~020601~001~
~Nov 15, 1996~No~OTC~MCNEIL CONSUMER HEALTHCARE
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CHILDREN'S ZYRTEC ALLERGY~MCNEIL
CONS~5MG **Federal Register determination that product was not discontinued or w
ithdrawn for safety or efficacy reasons**~N~021621~003~~Nov 16, 2007~No~DISCN~MC
NEIL CONSUMER HEALTHCARE
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CHILDREN'S ZYRTEC ALLERGY~MCNEIL
CONS~10MG **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons**~N~021621~004~~Nov 16, 2007~No~DISCN~M

CNEIL CONSUMER HEALTHCARE
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CHILDREN'S ZYRTEC HIVES RELIEF~MC
NEIL CONS~5MG **Federal Register determination that product was not discontinued
or withdrawn for safety or efficacy reasons**~N~021621~005~~Nov 16, 2007~No~DIS
CN~MCNEIL CONSUMER HEALTHCARE
CETIRIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~CHILDREN'S ZYRTEC HIVES RELIEF~MC
NEIL CONS~10MG **Federal Register determination that product was not discontinue
d or withdrawn for safety or efficacy reasons**~N~021621~006~~Nov 16, 2007~No~DI
SCN~MCNEIL CONSUMER HEALTHCARE
PEMOLINE~TABLET, CHEWABLE;ORAL~CYLERT~ABBOTT~37.5MG~N~017703~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
PHENYTOIN~TABLET, CHEWABLE;ORAL~DILANTIN~PFIZER PHARMS~50MG~A~084427~001~AB~Appr
oved Prior to Jan 1, 1982~Yes~RX~PFIZER PHARMACEUTICALS LTD
ERYTHROMYCIN ETHYLSUCCINATE~TABLET, CHEWABLE;ORAL~E.E.S.~ARBOR PHARMS INC~EQ 200
MG BASE~N~050297~002~~Approved Prior to Jan 1, 1982~No~DISCN~ARBOR PHARMACEUTICA
LS INC
CARBAMAZEPINE~TABLET, CHEWABLE;ORAL~EPITOL~TEVA~100MG~A~073524~001~AB~Jul 29, 19
HOMATROPINE METHYLBROMIDE~TABLET, CHEWABLE;ORAL~EQUIPIN~MISSION PHARMA~3MG~A~086
310~001~~Approved Prior to Jan 1, 1982~No~DISCN~MISSION PHARMACAL CO
ERYTHROMYCIN ETHYLSUCCINATE~TABLET, CHEWABLE;ORAL~ERYPED~ARBOR PHARMS INC~EQ 200
MG BASE~N~050297~003~~Jul 5, 1988~No~DISCN~ARBOR PHARMACEUTICALS INC
FAMOTIDINE~TABLET, CHEWABLE;ORAL~FAMOTIDINE~PERRIGO~10MG~A~075715~001~~Aug 22, 2
003~No~OTC~L PERRIGO CO
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET, CHEWABLE;ORAL~FEMCON FE~WARNER CHILCOTT
LLC~0.035MG;0.4MG~N~021490~001~AB~Nov 14, 2003~Yes~RX~WARNER CHILCOTT CO LLC
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE~TABLET, CHEWABLE;ORAL~FOAMCOAT~GUARDIA
N DRUG~80MG;20MG~A~071793~001~~Sep 4, 1987~No~OTC~GUARDIAN DRUG CO INC
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE~TABLET, CHEWABLE;ORAL~FOAMICON~NOVARTI
S~80MG;20MG~A~072687~001~~Jun 28, 1989~No~DISCN~NOVARTIS CONSUMER HEALTH INC
LANTHANUM CARBONATE~TABLET, CHEWABLE;ORAL~FOSRENOL~SHIRE LLC~EQ 1GM BASE~N~02146
8~004~~Nov 23, 2005~Yes~RX~SHIRE DEVELOPMENT LLC
LANTHANUM CARBONATE~TABLET, CHEWABLE;ORAL~FOSRENOL~SHIRE LLC~EQ 250MG BASE~N~021
468~001~~Oct 26, 2004~No~DISCN~SHIRE DEVELOPMENT LLC
468~002~~Oct 26, 2004~No~RX~SHIRE DEVELOPMENT LLC
468~003~~Nov 23, 2005~No~RX~SHIRE DEVELOPMENT LLC
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE~TABLET, CHEWABLE;ORAL~GAVISCON~SANOFI
AVENTIS US~80MG;20MG~N~018685~001~~Dec 9, 1983~No~OTC~SANOFI AVENTIS US LLC
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE~TABLET, CHEWABLE;ORAL~GAVISCON~SANOFI
AVENTIS US~160MG;40MG~N~018685~002~~Dec 9, 1983~Yes~OTC~SANOFI AVENTIS US LLC
IBUPROFEN~TABLET, CHEWABLE;ORAL~IBUPROFEN~PERRIGO~50MG~A~076359~001~~Jan 16, 200
IBUPROFEN~TABLET, CHEWABLE;ORAL~IBUPROFEN~PERRIGO~100MG~A~076359~002~~Jan 16, 20
ERYTHROMYCIN ESTOLATE~TABLET, CHEWABLE;ORAL~ILOSONE~DISTA~EQ 125MG BASE~A~061895
~001~~Approved Prior to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO DIV ELI LILLY AND
CO
ERYTHROMYCIN ESTOLATE~TABLET, CHEWABLE;ORAL~ILOSONE~DISTA~EQ 250MG BASE~A~061895
~002~~Approved Prior to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO DIV ELI LILLY AND
CO
LOPERAMIDE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~IMODIUM A-D EZ CHEWS~MCNEIL~2MG~N
~020448~001~~Jul 24, 1997~Yes~OTC~MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE~TABLET, CHEWABLE;ORAL~IMODIUM MULTI-SYMPTO
M RELIEF~MCNEIL~2MG;125MG~N~020606~001~~Jun 26, 1996~Yes~OTC~MCNEIL CONSUMER PRO
DUCTS CO DIV MCNEILAB INC
RALTEGRAVIR POTASSIUM~TABLET, CHEWABLE;ORAL~ISENTRESS~MERCK SHARP DOHME~EQ 25MG
BASE~N~203045~001~~Dec 21, 2011~No~RX~MERCK SHARP AND DOHME CORP
RALTEGRAVIR POTASSIUM~TABLET, CHEWABLE;ORAL~ISENTRESS~MERCK SHARP DOHME~EQ 100MG

BASE~N~203045~002~~Dec 21, 2011~Yes~RX~MERCK SHARP AND DOHME CORP
IBUPROFEN~TABLET, CHEWABLE;ORAL~JUNIOR STRENGTH ADVIL~PFIZER~100MG~N~020944~002~
~Dec 18, 1998~No~OTC~PFIZER INC
IBUPROFEN~TABLET, CHEWABLE;ORAL~JUNIOR STRENGTH MOTRIN~MCNEIL CONS~100MG~N~02060
1~003~~Nov 15, 1996~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMICTAL CD~GLAXOSMITHKLINE LLC~2MG~N~020764~0
04~AB~Sep 8, 2000~No~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMICTAL CD~GLAXOSMITHKLINE LLC~5MG~N~020764~0
01~AB~Aug 24, 1998~No~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMICTAL CD~GLAXOSMITHKLINE LLC~25MG~N~020764~
002~AB~Aug 24, 1998~Yes~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMICTAL CD~GLAXOSMITHKLINE LLC~100MG~N~020764
~003~~Aug 24, 1998~No~DISCN~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~ALEMBIC PHARMS LTD~5MG~A~201168~00
1~AB~Jun 12, 2014~No~RX~ALEMBIC PHARMACEUTICALS LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~ALEMBIC PHARMS LTD~25MG~A~201168~0
02~AB~Jun 12, 2014~No~RX~ALEMBIC PHARMACEUTICALS LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~AUROBINDO PHARMA~5MG~A~090401~002~
AB~Nov 4, 2009~No~RX~AUROBINDO PHARMA LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~AUROBINDO PHARMA~25MG~A~090401~003
~AB~Nov 4, 2009~No~RX~AUROBINDO PHARMA LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~DR REDDYS LABS LTD~5MG~A~076701~00
1~AB~Jan 22, 2009~No~RX~DR REDDYS LABORATORIES LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~DR REDDYS LABS LTD~25MG~A~076701~0
02~AB~Jan 22, 2009~No~RX~DR REDDYS LABORATORIES LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~GLENMARK GENERICS~5MG~A~079099~001
~AB~Feb 19, 2009~No~RX~GLENMARK GENERICS LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~GLENMARK GENERICS~25MG~A~079099~00
2~AB~Feb 19, 2009~No~RX~GLENMARK GENERICS LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~JUBILANT GENERICS~5MG~A~200220~001
~AB~Feb 28, 2011~No~RX~JUBILANT GENERICS LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~JUBILANT GENERICS~25MG~A~200220~00
2~AB~Feb 28, 2011~No~RX~JUBILANT GENERICS LTD
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~MYLAN~5MG~A~076630~001~AB~Jan 22,
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~MYLAN~25MG~A~076630~002~AB~Jan 22,
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~SANDOZ~5MG~A~078409~002~~Jan 22, 2
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~SANDOZ~25MG~A~078409~003~~Jan 22,
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~TARO~5MG~A~079204~001~AB~Feb 4, 20
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~TARO~25MG~A~079204~002~AB~Feb 4, 2
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~TEVA~5MG~A~076420~001~AB~Jun 21, 2
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~TEVA~25MG~A~076420~002~AB~Jun 21,
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~WATSON LABS~2MG~A~076928~001~AB~Ja
n 22, 2009~No~RX~WATSON LABORATORIES INC
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~WATSON LABS~5MG~A~076928~002~AB~Ja
n 22, 2009~No~RX~WATSON LABORATORIES INC
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~WATSON LABS~25MG~A~076928~003~AB~J
an 22, 2009~No~RX~WATSON LABORATORIES INC
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~ZYDUS PHARMS USA INC~5MG~A~078009~
002~AB~Jan 22, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
LAMOTRIGINE~TABLET, CHEWABLE;ORAL~LAMOTRIGINE~ZYDUS PHARMS USA INC~25MG~A~078009
~003~AB~Jan 22, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE~TABLET, CHEWABLE;ORAL~LOPERAMIDE HYDROCHLO

RIDE AND SIMETHICONE~PERRIGO~2MG;125MG~A~076029~001~~Aug 30, 2002~No~OTC~L PERRI
GO CO
MEBENDAZOLE~TABLET, CHEWABLE;ORAL~MEBENDAZOLE~AMEDRA PHARMS LLC~100MG~A~073580~0
01~~Jan 4, 1995~Yes~RX~AMEDRA PHARMACEUTICALS LLC
MECLIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~MECLIZINE HYDROCHLORIDE~IVAX SUB T
EVA PHARMS~25MG~A~084976~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMA
MECLIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~MECLIZINE HYDROCHLORIDE~NEXGEN PHA
RMA INC~25MG~A~086392~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA
INC
MECLIZINE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~MECLIZINE HYDROCHLORIDE~PLIVA~25MG
~A~088733~001~~Dec 11, 1985~No~DISCN~PLIVA INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~METHYLIN~MALLINCKRODT~2.5MG~
N~021475~001~AB~Apr 15, 2003~No~RX~MALLINCKRODT INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~METHYLIN~MALLINCKRODT~5MG~N~
021475~002~AB~Apr 15, 2003~No~RX~MALLINCKRODT INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~METHYLIN~MALLINCKRODT~10MG~N
~021475~003~AB~Apr 15, 2003~Yes~RX~MALLINCKRODT INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, CHEWABLE;ORAL~METHYLPHENIDATE HYDROCHLORID
E~NOVEL LABS INC~2.5MG~A~204115~001~AB~Feb 25, 2015~No~RX~NOVEL LABORATORIES INC
E~NOVEL LABS INC~5MG~A~204115~002~AB~Feb 25, 2015~No~RX~NOVEL LABORATORIES INC
E~NOVEL LABS INC~10MG~A~204115~003~AB~Feb 25, 2015~No~RX~NOVEL LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET, CHEWABLE;ORAL~MINASTRIN 24 FE~W
ARNER CHILCOTT LLC~0.02MG;1MG~N~203667~001~~May 8, 2013~Yes~RX~WARNER CHILCOTT C
O LLC
THIABENDAZOLE~TABLET, CHEWABLE;ORAL~MINTEZOL~MERCK SHARP DOHME~500MG~N~016096~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK SHARP AND DOHME CORP
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~APOTEX INC~EQ 4MG BA
SE~A~201508~001~AB~Aug 3, 2012~No~RX~APOTEX INC
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~APOTEX INC~EQ 5MG BA
SE~A~201508~002~AB~Aug 3, 2012~No~RX~APOTEX INC
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~AUROBINDO PHARMA LTD
~EQ 4MG BASE~A~202096~001~AB~Aug 3, 2012~No~RX~AUROBINDO PHARMA LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~AUROBINDO PHARMA LTD
~EQ 5MG BASE~A~202096~002~AB~Aug 3, 2012~No~RX~AUROBINDO PHARMA LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~DR REDDYS LABS LTD~E
Q 4MG BASE~A~201581~001~AB~Aug 6, 2012~No~RX~DR REDDYS LABORATORIES LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~DR REDDYS LABS LTD~E
Q 5MG BASE~A~201581~002~AB~Aug 6, 2012~No~RX~DR REDDYS LABORATORIES LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~JUBILANT GENERICS~EQ
4MG BASE~A~203795~001~AB~Feb 27, 2015~No~RX~JUBILANT GENERICS LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~JUBILANT GENERICS~EQ
5MG BASE~A~203795~002~AB~Feb 27, 2015~No~RX~JUBILANT GENERICS LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~KUDCO IRELAND~EQ 4MG
BASE~A~200405~001~AB~Aug 3, 2012~No~RX~KUDCO IRELAND LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~KUDCO IRELAND~EQ 5MG
BASE~A~200405~002~AB~Aug 3, 2012~No~RX~KUDCO IRELAND LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~MACLEODS PHARMS LTD~
EQ 4MG BASE~A~203582~001~AB~Mar 12, 2015~No~RX~MACLEODS PHARMACEUTICALS LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~MACLEODS PHARMS LTD~
EQ 5MG BASE~A~203582~002~AB~Mar 12, 2015~No~RX~MACLEODS PHARMACEUTICALS LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~MYLAN PHARMS INC~EQ
4MG BASE~A~079142~001~AB~Aug 3, 2012~No~RX~MYLAN PHARMACEUTICALS INC
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~MYLAN PHARMS INC~EQ
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~ROXANE~EQ 4MG BASE~A
~091128~001~AB~Aug 3, 2012~No~RX~ROXANE LABORATORIES INC
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~ROXANE~EQ 5MG BASE~A

~091128~002~AB~Aug 3, 2012~No~RX~ROXANE LABORATORIES INC
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~SANDOZ INC~EQ 4MG BA
SE~A~091414~001~AB~Aug 3, 2012~No~RX~SANDOZ INC
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~SANDOZ INC~EQ 5MG BA
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~TEVA PHARMS~EQ 4MG B
ASE~A~078723~001~AB~Aug 3, 2012~No~RX~TEVA PHARMACEUTICALS USA
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~TEVA PHARMS~EQ 5MG B
ASE~A~078723~002~AB~Aug 3, 2012~No~RX~TEVA PHARMACEUTICALS USA
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~TORRENT PHARMS LTD~E
Q 4MG BASE~A~090984~001~AB~Aug 3, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~TORRENT PHARMS LTD~E
Q 5MG BASE~A~090984~002~AB~Aug 3, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~UNIMARK REMEDIES LTD
~EQ 4MG BASE~A~203037~001~AB~Oct 30, 2014~No~RX~UNIMARK REMEDIES LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~UNIMARK REMEDIES LTD
~EQ 5MG BASE~A~203037~002~AB~Oct 30, 2014~No~RX~UNIMARK REMEDIES LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~VINTAGE PHARMS LLC~E
Q 4MG BASE~A~091588~001~AB~Aug 3, 2012~No~RX~VINTAGE PHARMACEUTICALS LLC
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~MONTELUKAST SODIUM~VINTAGE PHARMS LLC~E
Q 5MG BASE~A~091588~002~AB~Aug 3, 2012~No~RX~VINTAGE PHARMACEUTICALS LLC
IBUPROFEN~TABLET, CHEWABLE;ORAL~MOTRIN~MCNEIL PED~50MG~N~020135~001~~Nov 16, 199
4~No~DISCN~MCNEIL PEDIATRICS
IBUPROFEN~TABLET, CHEWABLE;ORAL~MOTRIN~MCNEIL PED~100MG~N~020135~002~~Nov 16, 19
94~No~DISCN~MCNEIL PEDIATRICS
NICLOSAMIDE~TABLET, CHEWABLE;ORAL~NICLOCIDE~BAYER PHARMS~500MG~N~018669~001~~May
14, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET, CHEWABLE;ORAL~NORETHINDRONE AND ETHINYL
ESTRADIOL AND FERROUS FUMARATE~AMNEAL PHARMS~0.035MG;0.4MG~A~078892~001~AB~Sep
26, 2011~No~RX~AMNEAL PHARMACEUTICALS OF NEW YORK LLC
ESTRADIOL AND FERROUS FUMARATE~BARR~0.035MG;0.4MG~A~078965~001~AB~Aug 5, 2010~N
o~RX~BARR LABORATORIES INC
ESTRADIOL AND FERROUS FUMARATE~FAMY CARE LTD~0.025MG;0.8MG~A~203371~001~AB~Apr
23, 2014~No~RX~FAMY CARE LTD
ESTRADIOL AND FERROUS FUMARATE~WARNER CHILCOTT~0.025MG;0.8MG~N~022573~001~AB~De
c 22, 2010~Yes~RX~WARNER CHILCOTT CO LLC
ERYTHROMYCIN ETHYLSUCCINATE~TABLET, CHEWABLE;ORAL~PEDIAMYCIN~ROSS LABS~EQ 200MG
BASE~A~062306~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROSS LABORATORIES DIV
ABBOTT LABORATORIES INC
PEMOLINE~TABLET, CHEWABLE;ORAL~PEMOLINE~ACTAVIS ELIZABETH~37.5MG~A~075678~001~~J
ul 26, 2000~No~DISCN~ACTAVIS ELIZABETH LLC
PEMOLINE~TABLET, CHEWABLE;ORAL~PEMOLINE~TEVA PHARMS~37.5MG~A~075555~001~~Feb 18,
FAMOTIDINE~TABLET, CHEWABLE;ORAL~PEPCID AC~MCNEIL CONS~10MG~N~020801~001~~Sep 24
, 1998~No~DISCN~MCNEIL CONSUMER HEALTHCARE
FAMOTIDINE~TABLET, CHEWABLE;ORAL~PEPCID AC~MCNEIL CONS~20MG~N~020801~002~~Dec 17
, 2007~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE~TABLET, CHEWABLE;ORAL~PEPCID
COMPLETE~MCNEIL CONS~800MG;10MG;165MG~N~020958~001~~Oct 16, 2000~Yes~OTC~MCNEIL
CONSUMER HEALTHCARE
PHENYTOIN~TABLET, CHEWABLE;ORAL~PHENYTOIN~COREPHARMA~50MG~A~040884~001~AB~Nov 28
, 2014~No~RX~COREPHARMA LLC
PHENYTOIN~TABLET, CHEWABLE;ORAL~PHENYTOIN~MYLAN PHARMS INC~50MG~A~200691~001~AB~
Dec 26, 2012~No~RX~MYLAN PHARMACEUTICALS INC
PHENYTOIN~TABLET, CHEWABLE;ORAL~PHENYTOIN~TARO~50MG~A~200565~001~AB~Apr 17, 2014
~No~RX~TARO PHARMACEUTICALS USA INC
AMPICILLIN/AMPICILLIN TRIHYDRATE~TABLET, CHEWABLE;ORAL~POLYCILLIN~BRISTOL~EQ 125

MG BASE~N~050093~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL LABORATORIE
S INC DIV BRISTOL MYERS CO
CEFACLOR~TABLET, CHEWABLE;ORAL~RANICLOR~RANBAXY LABS LTD~EQ 125MG BASE~A~065092~
001~~Dec 22, 2003~No~DISCN~RANBAXY LABORATORIES LTD
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~SINGULAIR~MERCK~EQ 4MG BASE~N~020830~00
2~AB~Mar 3, 2000~No~RX~MERCK AND CO INC
MONTELUKAST SODIUM~TABLET, CHEWABLE;ORAL~SINGULAIR~MERCK~EQ 5MG BASE~N~020830~00
1~AB~Feb 20, 1998~Yes~RX~MERCK AND CO INC
ISOSORBIDE DINITRATE~TABLET, CHEWABLE;ORAL~SORBITRATE~ASTRAZENECA~5MG~N~016776~0
02~~Apr 1, 1996~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
ISOSORBIDE DINITRATE~TABLET, CHEWABLE;ORAL~SORBITRATE~ASTRAZENECA~10MG~N~016776~
003~~Apr 1, 1996~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
CEFIXIME~TABLET, CHEWABLE;ORAL~SUPRAX~LUPIN LTD~100MG~A~065380~001~~Oct 25, 2010
~No~RX~LUPIN LTD
~No~RX~LUPIN LTD
~Yes~RX~LUPIN LTD
METHDILAZINE~TABLET, CHEWABLE;ORAL~TACARYL~WESTWOOD SQUIBB~3.6MG~N~011950~009~~A
pproved Prior to Jan 1, 1982~No~DISCN~WESTWOOD SQUIBB PHARMACEUTICALS INC
CARBAMAZEPINE~TABLET, CHEWABLE;ORAL~TEGRETOL~NOVARTIS~100MG~N~018281~001~AB~Appr
oved Prior to Jan 1, 1982~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
THEOPHYLLINE~TABLET, CHEWABLE;ORAL~THEOPHYL~ORTHO MCNEIL PHARM~100MG~A~086506~00
1~~Sep 12, 1985~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
SUCROFERRIC OXYHYDROXIDE~TABLET, CHEWABLE;ORAL~VELPHORO~VIFOR FRESENIUS~500MG~N~
205109~001~~Nov 27, 2013~Yes~RX~VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE
MEBENDAZOLE~TABLET, CHEWABLE;ORAL~VERMOX~JANSSEN PHARMS~100MG~N~017481~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~JANSSEN PHARMACEUTICALS INC
DIDANOSINE~TABLET, CHEWABLE;ORAL~VIDEX~BRISTOL MYERS SQUIBB~25MG~N~020154~002~~O
ct 9, 1991~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
DIDANOSINE~TABLET, CHEWABLE;ORAL~VIDEX~BRISTOL MYERS SQUIBB~50MG~N~020154~003~~O
ct 9, 1991~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
DIDANOSINE~TABLET, CHEWABLE;ORAL~VIDEX~BRISTOL MYERS SQUIBB~100MG~N~020154~004~~
Oct 9, 1991~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE~TABLET, CHEWABLE;ORAL~ZEGERI
D~SANTARUS~700MG;20MG;600MG~N~021850~001~~Mar 24, 2006~No~DISCN~SANTARUS INC
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE~TABLET, CHEWABLE;ORAL~ZEGERI
D~SANTARUS~700MG;40MG;600MG~N~021850~002~~Mar 24, 2006~No~DISCN~SANTARUS INC
ERYTHROMYCIN~TABLET, COATED PARTICLES;ORAL~PCE~ARBOR PHARMS LLC~333MG~N~050611~0
01~~Sep 9, 1986~No~RX~ARBOR PHARMACEUTICALS LLC
ERYTHROMYCIN~TABLET, COATED PARTICLES;ORAL~PCE~ARBOR PHARMS LLC~500MG~N~050611~0
02~~Aug 22, 1990~Yes~RX~ARBOR PHARMACEUTICALS LLC
LANSOPRAZOLE~TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL~LANSOPRAZOLE~AN
I PHARMS INC~15MG~A~078730~001~~Oct 15, 2010~No~DISCN~ANI PHARMACEUTICALS INC
LANSOPRAZOLE~TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL~LANSOPRAZOLE~AN
I PHARMS INC~30MG~A~078730~002~~Oct 15, 2010~No~DISCN~ANI PHARMACEUTICALS INC
LANSOPRAZOLE~TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL~PREVACID~TAKEDA
PHARMS USA~15MG~N~021428~001~~Aug 30, 2002~No~RX~TAKEDA PHARMACEUTICALS USA INC
LANSOPRAZOLE~TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL~PREVACID~TAKEDA
PHARMS USA~30MG~N~021428~002~~Aug 30, 2002~Yes~RX~TAKEDA PHARMACEUTICALS USA IN

C
ACAMPROSATE CALCIUM~TABLET, DELAYED RELEASE;ORAL~ACAMPROSATE CALCIUM~BARR LABS D
IV TEVA~333MG~A~200143~001~AB~Nov 18, 2013~No~RX~BARR LABORATORIES INC SUB TEVA
PHARMACEUTICALS USA
ACAMPROSATE CALCIUM~TABLET, DELAYED RELEASE;ORAL~ACAMPROSATE CALCIUM~GLENMARK GE
NERICS~333MG~A~202229~001~AB~Jul 16, 2013~No~RX~GLENMARK GENERICS LTD
ACAMPROSATE CALCIUM~TABLET, DELAYED RELEASE;ORAL~ACAMPROSATE CALCIUM~MYLAN PHARM
S INC~333MG~A~200142~001~AB~Mar 11, 2014~No~RX~MYLAN PHARMACEUTICALS INC
RABEPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~ACIPHEX~EISAI INC~10MG **Federal
y or efficacy reasons**~N~020973~001~~May 29, 2002~No~DISCN~EISAI INC
RABEPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~ACIPHEX~EISAI INC~20MG~N~020973~
002~AB~Aug 19, 1999~Yes~RX~EISAI INC
AMINOPHYLLINE~TABLET, DELAYED RELEASE;ORAL~AMINOPHYLLINE~IMPAX LABS~100MG~A~0845
AMINOPHYLLINE~TABLET, DELAYED RELEASE;ORAL~AMINOPHYLLINE~IMPAX LABS~200MG~A~0845
AMINOPHYLLINE~TABLET, DELAYED RELEASE;ORAL~AMINOPHYLLINE~TABLICAPS~100MG~A~08463
2~002~~Approved Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
AMINOPHYLLINE~TABLET, DELAYED RELEASE;ORAL~AMINOPHYLLINE~VALE~100MG~A~084531~001
~~Approved Prior to Jan 1, 1982~No~DISCN~VALE CHEMICAL CO INC
AMINOPHYLLINE~TABLET, DELAYED RELEASE;ORAL~AMINOPHYLLINE~VALE~200MG~A~084530~001
~~Approved Prior to Jan 1, 1982~No~DISCN~VALE CHEMICAL CO INC
DICLOFENAC SODIUM; MISOPROSTOL~TABLET, DELAYED RELEASE;ORAL~ARTHROTEC~GD SEARLE
LLC~50MG;0.2MG~N~020607~001~AB~Dec 24, 1997~No~RX~GD SEARLE LLC
DICLOFENAC SODIUM; MISOPROSTOL~TABLET, DELAYED RELEASE;ORAL~ARTHROTEC~GD SEARLE
LLC~75MG;0.2MG~N~020607~002~AB~Dec 24, 1997~Yes~RX~GD SEARLE LLC
MESALAMINE~TABLET, DELAYED RELEASE;ORAL~ASACOL~WARNER CHILCOTT LLC~400MG~N~01965
1~001~~Jan 31, 1992~Yes~RX~WARNER CHILCOTT CO LLC
MESALAMINE~TABLET, DELAYED RELEASE;ORAL~ASACOL HD~WARNER CHILCOTT LLC~800MG~N~02
1830~001~~May 29, 2008~Yes~RX~WARNER CHILCOTT CO LLC
RISEDRONATE SODIUM~TABLET, DELAYED RELEASE;ORAL~ATELVIA~WARNER CHILCOTT LLC~35MG
~N~022560~001~~Oct 8, 2010~Yes~RX~WARNER CHILCOTT CO LLC
SULFASALAZINE~TABLET, DELAYED RELEASE;ORAL~AZULFIDINE EN-TABS~PHARMACIA AND UPJO
HN~500MG~N~007073~002~AB~Apr 6, 1983~Yes~RX~PHARMACIA AND UPJOHN CO
ACAMPROSATE CALCIUM~TABLET, DELAYED RELEASE;ORAL~CAMPRAL~FOREST LABS~333MG~N~021
431~001~AB~Jul 29, 2004~Yes~RX~FOREST LABORATORIES INC
OXTRIPHYLLINE~TABLET, DELAYED RELEASE;ORAL~CHOLEDYL~PARKE DAVIS~100MG~N~009268~0
OXTRIPHYLLINE~TABLET, DELAYED RELEASE;ORAL~CHOLEDYL~PARKE DAVIS~200MG~N~009268~0
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DEPAKOTE~ABBVIE~EQ 125MG VALPROIC
ACID~N~018723~003~AB~Oct 26, 1984~No~RX~ABBVIE INC
ACID~N~018723~001~AB~Mar 10, 1983~No~RX~ABBVIE INC
ACID~N~018723~002~AB~Mar 10, 1983~Yes~RX~ABBVIE INC
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DEPAKOTE CP~ABBOTT~EQ 250MG BASE~
N~019794~001~~Jul 11, 1990~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS
DIV
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DEPAKOTE CP~ABBOTT~EQ 500MG BASE~
N~019794~002~~Jul 11, 1990~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS
DIV
SULFOXONE SODIUM~TABLET, DELAYED RELEASE;ORAL~DIASONE SODIUM~ABBVIE~165MG~N~0060
44~003~~Approved Prior to Jan 1, 1982~No~DISCN~ABBVIE INC
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE~TABLET, DELAYED RELEASE;ORAL~DICL
EGIS~DUCHESNAY~10MG;10MG~N~021876~001~~Apr 8, 2013~Yes~RX~DUCHESNAY INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~ACTAVIS ELIZABE
TH~50MG~A~074514~001~AB~Mar 26, 1996~No~RX~ACTAVIS ELIZABETH LLC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~ACTAVIS ELIZABE

TH~75MG~A~074514~002~AB~Mar 26, 1996~No~RX~ACTAVIS ELIZABETH LLC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~CARLSBAD~25MG~A
~075185~002~AB~Nov 13, 1998~No~RX~CARLSBAD TECHNOLOGY INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~MYLAN PHARMS IN
C~50MG~A~075281~002~AB~Feb 12, 2002~No~RX~MYLAN PHARMACEUTICALS INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~MYLAN PHARMS IN
C~75MG~A~075281~003~AB~Feb 12, 2002~No~RX~MYLAN PHARMACEUTICALS INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~NOSTRUM LABS~50
MG~A~074986~001~~Feb 26, 1999~No~DISCN~NOSTRUM LABORATORIES INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~NOSTRUM LABS~75
MG~A~074986~002~~Feb 26, 1999~No~DISCN~NOSTRUM LABORATORIES INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~PLIVA~50MG~A~07
4432~002~~Jul 29, 1999~No~DISCN~PLIVA INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~PLIVA~75MG~A~07
4432~003~~Jul 29, 1999~No~DISCN~PLIVA INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~ROXANE~25MG~A~0
74391~001~~Jun 29, 1995~No~DISCN~ROXANE LABORATORIES INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~SANDOZ~25MG~A~0
74376~001~AB~Sep 28, 1995~Yes~RX~SANDOZ INC
74376~002~AB~Sep 28, 1995~Yes~RX~SANDOZ INC
74394~001~AB~Nov 30, 1995~Yes~RX~SANDOZ INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~TEVA~50MG~A~074
723~001~~Mar 30, 1999~No~DISCN~TEVA PHARMACEUTICALS USA INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~TEVA~75MG~A~074
390~001~~Aug 15, 1996~No~DISCN~TEVA PHARMACEUTICALS USA INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~TEVA PHARMS~25M
G~A~074459~001~~Jun 25, 1997~No~DISCN~TEVA PHARMACEUTICALS USA
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM~UNIQUE PHARM LA
BS~25MG~A~090066~001~AB~Dec 1, 2010~No~RX~UNIQUE PHARMACEUTICAL LABORATORIES
BS~50MG~A~090066~002~AB~Dec 1, 2010~No~RX~UNIQUE PHARMACEUTICAL LABORATORIES
BS~75MG~A~077863~003~AB~Jun 8, 2007~No~RX~UNIQUE PHARMACEUTICAL LABORATORIES
DICLOFENAC SODIUM; MISOPROSTOL~TABLET, DELAYED RELEASE;ORAL~DICLOFENAC SODIUM AN
D MISOPROSTOL~ACTAVIS LABS FL INC~50MG;0.2MG~A~201089~001~AB~Jul 9, 2012~No~RX~A
CTAVIS LABORATORIES FL INC
D MISOPROSTOL~ACTAVIS LABS FL INC~75MG;0.2MG~A~201089~002~AB~Jul 9, 2012~No~RX~A
D MISOPROSTOL~EAGLE PHARMS~50MG;0.2MG~A~200540~001~AB~Mar 14, 2014~No~RX~EAGLE P
HARMACEUTICALS INC
D MISOPROSTOL~EAGLE PHARMS~75MG;0.2MG~A~200540~002~AB~Mar 14, 2014~No~RX~EAGLE P
HARMACEUTICALS INC

D MISOPROSTOL~SANDOZ~50MG;0.2MG~A~200158~001~AB~May 9, 2013~No~RX~SANDOZ INC
D MISOPROSTOL~SANDOZ~75MG;0.2MG~A~200158~002~AB~May 9, 2013~No~RX~SANDOZ INC
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~DIETHYLSTILBESTROL~LILLY~0.1MG~N
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~DIETHYLSTILBESTROL~LILLY~0.25MG~
N~004039~005~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~DIETHYLSTILBESTROL~LILLY~0.5MG~N
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~DIETHYLSTILBESTROL~LILLY~1MG~N~0
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~DIETHYLSTILBESTROL~LILLY~5MG~N~0
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~ACTAVIS LABS FL
INC~EQ 500MG VALPROIC ACID~A~079080~001~AB~Feb 25, 2011~No~RX~ACTAVIS LABORATOR
IES FL INC
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~ANCHEN PHARMS~E
Q 500MG VALPROIC ACID~A~078411~001~AB~Nov 3, 2008~No~RX~ANCHEN PHARMACEUTICALS T
AIWAN INC
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~AUROBINDO PHARM
A LTD~EQ 125MG VALPROIC ACID~A~090554~001~AB~Apr 21, 2011~No~RX~AUROBINDO PHARMA
LIMITED
LIMITED
LIMITED
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~DR REDDYS LABS
LTD~EQ 125MG VALPROIC ACID~A~078755~001~AB~Jul 29, 2008~No~RX~DR REDDYS LABORATO
RIES LTD
RIES LTD
RIES LTD
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~LUPIN~EQ 125MG
VALPROIC ACID~A~078790~001~AB~Jul 29, 2008~No~RX~LUPIN LTD
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~MYLAN~EQ 125MG
VALPROIC ACID~A~077254~001~~Jul 29, 2008~No~DISCN~MYLAN PHARMACEUTICALS INC
VALPROIC ACID~A~090062~001~AB~Mar 17, 2009~No~RX~MYLAN PHARMACEUTICALS INC
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~NU PHARM~EQ 125
MG VALPROIC ACID~A~077615~003~AB~Jul 29, 2008~No~RX~NU PHARM INC

DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~ORCHID HLTHCARE
~EQ 125MG VALPROIC ACID~A~078853~001~AB~Nov 25, 2008~No~RX~ORCHID HEALTHCARE
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~SANDOZ~EQ 125MG
VALPROIC ACID~A~078290~003~AB~Jul 29, 2008~No~RX~SANDOZ INC
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~SUN PHARM INDS~
EQ 125MG VALPROIC ACID~A~078597~001~AB~Jul 29, 2008~No~RX~SUN PHARMACEUTICAL IND
USTRIES LTD
USTRIES LTD
USTRIES LTD
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~TEVA~EQ 125MG V
ALPROIC ACID~A~076941~001~AB~Jul 29, 2008~No~RX~TEVA PHARMACEUTICALS USA INC
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~UNICHEM LABS LT
D~EQ 125MG VALPROIC ACID~A~079163~001~AB~Apr 5, 2011~No~RX~UNICHEM LABORATORIES
LIMITED
LIMITED
LIMITED
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~UPSHER SMITH~EQ
125MG VALPROIC ACID~A~078182~001~AB~Jul 29, 2008~No~RX~UPSHER SMITH LABORATORIE
S INC
S INC
S INC
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~VINTAGE~EQ 125M
G VALPROIC ACID~A~090210~001~AB~Nov 30, 2009~No~RX~VINTAGE PHARMACEUTICALS LLC
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~WOCKHARDT~EQ 12
5MG VALPROIC ACID~A~077296~001~AB~Jul 31, 2008~No~RX~WOCKHARDT LTD
DIVALPROEX SODIUM~TABLET, DELAYED RELEASE;ORAL~DIVALPROEX SODIUM~ZYDUS PHARMS US
A INC~EQ 125MG VALPROIC ACID~A~077100~001~AB~Mar 5, 2009~No~RX~ZYDUS PHARMACEUTI

CALS USA INC
CALS USA INC
CALS USA INC
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DORYX~MAYNE PHARMA~EQ 75MG BASE
~N~050795~001~AB~May 6, 2005~No~RX~MAYNE PHARMA INTERNATIONAL PTY LTD
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DORYX~MAYNE PHARMA~EQ 80MG BASE
~N~050795~004~~Apr 11, 2013~No~RX~MAYNE PHARMA INTERNATIONAL PTY LTD
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DORYX~MAYNE PHARMA~EQ 100MG BAS
E~N~050795~002~AB~May 6, 2005~No~RX~MAYNE PHARMA INTERNATIONAL PTY LTD
E~N~050795~003~AB~Jun 20, 2008~No~RX~MAYNE PHARMA INTERNATIONAL PTY LTD
E~N~050795~005~~Apr 11, 2013~Yes~RX~MAYNE PHARMA INTERNATIONAL PTY LTD
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXTERIC~MAYNE PHARMA~EQ 50MG B
ASE~N~050795~006~~Dec 19, 2014~No~RX~MAYNE PHARMA INTERNATIONAL PTY LTD
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~ACTAVIS ELI
ZABETH~EQ 75MG BASE~A~090134~001~AB~Dec 14, 2011~No~RX~ACTAVIS ELIZABETH LLC
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~ACTAVIS ELI
ZABETH~EQ 100MG BASE~A~090134~002~AB~Dec 14, 2011~No~RX~ACTAVIS ELIZABETH LLC
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~HERITAGE PH
ARMS INC~EQ 75MG BASE~A~200856~001~AB~Apr 30, 2013~No~RX~HERITAGE PHARMACEUTICAL
S INC
ARMS INC~EQ 100MG BASE~A~200856~002~AB~Apr 30, 2013~No~RX~HERITAGE PHARMACEUTICA
LS INC
ARMS INC~EQ 150MG BASE~A~200856~003~AB~Apr 30, 2013~No~RX~HERITAGE PHARMACEUTICA
LS INC
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~IMPAX LABS
INC~EQ 75MG BASE~A~090505~001~AB~Dec 28, 2010~No~RX~IMPAX LABORATORIES INC
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~IMPAX LABS
INC~EQ 100MG BASE~A~090505~002~AB~Dec 28, 2010~No~RX~IMPAX LABORATORIES INC
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~MYLAN~EQ 75
MG BASE~A~090431~001~AB~Dec 28, 2010~No~RX~MYLAN PHARMACEUTICALS INC
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~MYLAN~EQ 10
0MG BASE~A~090431~002~AB~Dec 28, 2010~No~RX~MYLAN PHARMACEUTICALS INC
DOXYCYCLINE HYCLATE~TABLET, DELAYED RELEASE;ORAL~DOXYCYCLINE HYCLATE~MYLAN PHARM
S INC~EQ 150MG BASE~A~091052~001~AB~Feb 8, 2012~No~RX~MYLAN PHARMACEUTICALS INC
DIRITHROMYCIN~TABLET, DELAYED RELEASE;ORAL~DYNABAC~LILLY RES LABS~250MG~N~050678
~001~~Jun 19, 1995~No~DISCN~LILLY RESEARCH LABORATORIES
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~E-BASE~BARR~333MG~A~063028~001~~May 15
, 1990~No~DISCN~BARR LABORATORIES INC
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~E-BASE~BARR~333MG~A~063086~001~~May 15
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~E-BASE~BARR~500MG~A~062999~001~~Nov 25
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~E-MYCIN~ARBOR PHARMS INC~250MG~A~06027
2~001~~Approved Prior to Jan 1, 1982~No~DISCN~ARBOR PHARMACEUTICALS INC
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~E-MYCIN~ARBOR PHARMS INC~333MG~A~06027
2~002~~Approved Prior to Jan 1, 1982~No~DISCN~ARBOR PHARMACEUTICALS INC
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~EC-NAPROSYN~ROCHE PALO~375MG~N~020067~002~
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~EC-NAPROSYN~ROCHE PALO~500MG~N~020067~003~
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~ERY-TAB~ARBOR PHARMS LLC~250MG~A~06229
8~001~~Approved Prior to Jan 1, 1982~No~RX~ARBOR PHARMACEUTICALS LLC

8~003~~Mar 29, 1982~No~RX~ARBOR PHARMACEUTICALS LLC
8~002~~Approved Prior to Jan 1, 1982~Yes~RX~ARBOR PHARMACEUTICALS LLC
CROFELEMER~TABLET, DELAYED RELEASE;ORAL~FULYZAQ~SALIX PHARMS~125MG~N~202292~001~
~Dec 31, 2012~Yes~RX~SALIX PHARMACEUTICALS INC
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~ILOTYCIN~DISTA~250MG~A~061910~001~~App
roved Prior to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO DIV ELI LILLY AND CO
MESALAMINE~TABLET, DELAYED RELEASE;ORAL~LIALDA~SHIRE~1.2GM~N~022000~001~~Jan 16,
2007~Yes~RX~SHIRE DEVELOPMENT INC
MYCOPHENOLIC ACID~TABLET, DELAYED RELEASE;ORAL~MYCOPHENOLIC ACID~APOTEX INC~180M
G~A~091558~001~AB~Aug 21, 2012~No~RX~APOTEX INC
MYCOPHENOLIC ACID~TABLET, DELAYED RELEASE;ORAL~MYCOPHENOLIC ACID~APOTEX INC~360M
G~A~091558~002~AB~Aug 19, 2014~No~RX~APOTEX INC
MYCOPHENOLIC ACID~TABLET, DELAYED RELEASE;ORAL~MYCOPHENOLIC ACID~MYLAN PHARMS IN
C~180MG~A~091248~002~AB~Jan 8, 2014~No~RX~MYLAN PHARMACEUTICALS INC
MYCOPHENOLIC ACID~TABLET, DELAYED RELEASE;ORAL~MYCOPHENOLIC ACID~MYLAN PHARMS IN
C~360MG~A~091248~001~AB~Jan 8, 2014~No~RX~MYLAN PHARMACEUTICALS INC
MYCOPHENOLIC ACID~TABLET, DELAYED RELEASE;ORAL~MYCOPHENOLIC ACID~TEVA PHARMS USA
~180MG~A~202720~001~AB~Oct 30, 2014~No~RX~TEVA PHARMACEUTICALS USA
MYCOPHENOLIC ACID~TABLET, DELAYED RELEASE;ORAL~MYCOPHENOLIC ACID~TEVA PHARMS USA
~360MG~A~202720~002~AB~Oct 30, 2014~No~RX~TEVA PHARMACEUTICALS USA
MYCOPHENOLIC ACID~TABLET, DELAYED RELEASE;ORAL~MYFORTIC~NOVARTIS~180MG~N~050791~
001~AB~Feb 27, 2004~No~RX~NOVARTIS PHARMACEUTICALS CORP
MYCOPHENOLIC ACID~TABLET, DELAYED RELEASE;ORAL~MYFORTIC~NOVARTIS~360MG~N~050791~
002~AB~Feb 27, 2004~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~ACTAVIS ELIZABETH~375MG~A~074936~
001~~Feb 24, 1998~No~DISCN~ACTAVIS ELIZABETH LLC
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~ACTAVIS ELIZABETH~500MG~A~074936~
002~~Feb 24, 1998~No~DISCN~ACTAVIS ELIZABETH LLC
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~INVAGEN PHARMS~375MG~A~091432~001
~AB~Sep 19, 2011~No~RX~INVAGEN PHARMACEUTICALS INC
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~INVAGEN PHARMS~500MG~A~091432~002
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~MYLAN PHARMS INC~375MG~A~075390~0
01~AB~Apr 19, 2001~No~RX~MYLAN PHARMACEUTICALS INC
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~MYLAN PHARMS INC~500MG~A~075390~0
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~PLIVA~375MG~A~075337~001~AB~May 2
6, 1999~No~RX~PLIVA INC
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~PLIVA~500MG~A~075337~002~AB~May 2
6, 1999~No~RX~PLIVA INC
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~SANDOZ~375MG~A~075061~001~AB~Feb
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~SANDOZ~500MG~A~075061~002~AB~Feb
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~TEVA~375MG~A~075227~001~AB~Jun 30
NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN~TEVA~500MG~A~075227~002~AB~Jun 30
ESOMEPRAZOLE MAGNESIUM; NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN AND ESOME
PRAZOLE MAGNESIUM~DR REDDYS LABS LTD~EQ 20MG BASE;375MG~A~202461~001~AB~Sep 27,
ESOMEPRAZOLE MAGNESIUM; NAPROXEN~TABLET, DELAYED RELEASE;ORAL~NAPROXEN AND ESOME
PRAZOLE MAGNESIUM~DR REDDYS LABS LTD~EQ 20MG BASE;500MG~A~202461~002~AB~Sep 27,
POSACONAZOLE~TABLET, DELAYED RELEASE;ORAL~NOXAFIL~MERCK SHARP DOHME~100MG~N~2050
53~001~~Nov 25, 2013~Yes~RX~MERCK SHARP AND DOHME CORP
OMEPRAZOLE~TABLET, DELAYED RELEASE;ORAL~OMEPRAZOLE~DEXCEL PHARMA~20MG~N~022032~0
01~~Dec 4, 2007~Yes~OTC~DEXCEL PHARMA TECHNOLOGIES LTD

OXTRIPHYLLINE~TABLET, DELAYED RELEASE;ORAL~OXTRIPHYLLINE~WATSON LABS~100MG~A~087
OXTRIPHYLLINE~TABLET, DELAYED RELEASE;ORAL~OXTRIPHYLLINE~WATSON LABS~200MG~A~087
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~ACTAVIS TOT
OWA~EQ 20MG BASE~A~090797~001~AB~Feb 7, 2011~No~RX~ACTAVIS TOTOWA LLC
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~ACTAVIS TOT
OWA~EQ 40MG BASE~A~090797~002~AB~Feb 7, 2011~No~RX~ACTAVIS TOTOWA LLC
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~APOTEX INC~
EQ 20MG BASE~A~090807~001~AB~May 2, 2012~No~RX~APOTEX INC
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~APOTEX INC~
EQ 40MG BASE~A~090807~002~AB~May 2, 2012~No~RX~APOTEX INC
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~AUROBINDO P
HARMA LTD~EQ 20MG BASE~A~202038~001~AB~Sep 28, 2012~No~RX~AUROBINDO PHARMA LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~AUROBINDO P
HARMA LTD~EQ 40MG BASE~A~202038~002~AB~Sep 28, 2012~No~RX~AUROBINDO PHARMA LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~DR REDDYS L
ABS LTD~EQ 20MG BASE~A~077619~001~AB~Jan 19, 2011~No~RX~DR REDDYS LABORATORIES L
TD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~DR REDDYS L
ABS LTD~EQ 40MG BASE~A~077619~002~AB~Jan 19, 2011~No~RX~DR REDDYS LABORATORIES L
TD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~HETERO LABS
LTD V~EQ 20MG BASE~A~202882~001~AB~Sep 10, 2014~No~RX~HETERO LABS LTD UNIT V
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~HETERO LABS
LTD V~EQ 40MG BASE~A~202882~002~AB~Sep 10, 2014~No~RX~HETERO LABS LTD UNIT V
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~JUBILANT GE
NERICS~EQ 20MG BASE~A~090901~001~AB~Aug 30, 2011~No~RX~JUBILANT GENERICS LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~JUBILANT GE
NERICS~EQ 40MG BASE~A~090901~002~AB~Aug 30, 2011~No~RX~JUBILANT GENERICS LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~KUDCO IRELA
ND~EQ 20MG BASE~A~078281~001~AB~Jan 20, 2011~No~RX~KUDCO IRELAND LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~KUDCO IRELA
ND~EQ 40MG BASE~A~078281~002~AB~Jan 20, 2011~No~RX~KUDCO IRELAND LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~MACLEODS PH
ARMS LTD~EQ 20MG BASE~A~200821~001~AB~Feb 16, 2012~No~RX~MACLEODS PHARMACEUTICAL
S LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~MACLEODS PH
ARMS LTD~EQ 40MG BASE~A~200821~002~AB~Feb 16, 2012~No~RX~MACLEODS PHARMACEUTICAL
S LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~MYLAN PHARM
S INC~EQ 20MG BASE~A~090970~001~AB~Jan 19, 2011~No~RX~MYLAN PHARMACEUTICALS INC
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~MYLAN PHARM
S INC~EQ 40MG BASE~A~090970~002~AB~Jan 19, 2011~No~RX~MYLAN PHARMACEUTICALS INC
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~ORCHID HLTH
CARE~EQ 20MG BASE~A~202052~001~AB~Dec 2, 2014~No~RX~ORCHID HEALTHCARE
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~ORCHID HLTH
CARE~EQ 40MG BASE~A~202052~002~AB~Dec 2, 2014~No~RX~ORCHID HEALTHCARE
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~PERRIGO R A
ND D~EQ 20MG BASE~A~203024~001~AB~May 7, 2014~No~RX~PERRIGO R AND D CO
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~RANBAXY LAB
S LTD~EQ 20MG BASE~A~200794~001~AB~May 2, 2012~No~RX~RANBAXY LABORATORIES LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~RANBAXY LAB
S LTD~EQ 40MG BASE~A~200794~002~AB~May 2, 2012~No~RX~RANBAXY LABORATORIES LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~SUN PHARMA
GLOBAL~EQ 20MG BASE~A~077058~001~AB~Sep 10, 2007~No~RX~SUN PHARMA GLOBAL FZE
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~SUN PHARMA
GLOBAL~EQ 40MG BASE~A~077058~002~AB~Sep 10, 2007~No~RX~SUN PHARMA GLOBAL FZE
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~TEVA~EQ 20M
G BASE~A~077056~001~AB~Aug 2, 2007~No~RX~TEVA PHARMACEUTICALS USA INC

PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~TEVA~EQ 40M
G BASE~A~077056~002~AB~Aug 2, 2007~No~RX~TEVA PHARMACEUTICALS USA INC
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~TORRENT PHA
RMS~EQ 20MG BASE~A~090074~001~AB~Jan 19, 2011~No~RX~TORRENT PHARMACEUTICALS LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~TORRENT PHA
RMS~EQ 40MG BASE~A~090074~002~AB~Jan 19, 2011~No~RX~TORRENT PHARMACEUTICALS LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~WOCKHARDT~E
Q 20MG BASE~A~091231~001~AB~Jan 19, 2011~No~RX~WOCKHARDT LTD
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PANTOPRAZOLE SODIUM~WOCKHARDT~E
Q 40MG BASE~A~091231~002~AB~Jan 19, 2011~No~RX~WOCKHARDT LTD
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET, DELAYED RELEASE;ORAL~PRAMIPEXOLE DIHYDROCHLO
RIDE~SANDOZ~0.375MG~A~202353~001~AB~Dec 4, 2014~No~RX~SANDOZ INC
RIDE~SANDOZ~3MG~A~202353~004~AB~Dec 4, 2014~No~RX~SANDOZ INC
OMEPRAZOLE MAGNESIUM~TABLET, DELAYED RELEASE;ORAL~PRILOSEC OTC~ASTRAZENECA PHARM
S~EQ 20MG BASE~N~021229~001~~Jun 20, 2003~Yes~OTC~ASTRAZENECA PHARMACEUTICALS LP
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PROTONIX~WYETH PHARMS INC~EQ 20
MG BASE~N~020987~002~AB~Jun 12, 2001~No~RX~WYETH PHARMACEUTICALS INC
PANTOPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~PROTONIX~WYETH PHARMS INC~EQ 40
MG BASE~N~020987~001~AB~Feb 2, 2000~Yes~RX~WYETH PHARMACEUTICALS INC
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~R-P MYCIN~SOLVAY~250MG~A~061659~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
RABEPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~RABEPRAZOLE SODIUM~DR REDDYS LAB
S LTD~20MG~A~076824~001~AB~Nov 8, 2013~No~RX~DR REDDYS LABORATORIES LTD
RABEPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~RABEPRAZOLE SODIUM~KREMERS URBAN
DEV~20MG~A~090678~001~AB~Nov 8, 2013~No~RX~KREMERS URBAN DEVELOPMENT CO
RABEPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~RABEPRAZOLE SODIUM~LUPIN LTD~20M
G~A~078964~001~AB~Nov 8, 2013~No~RX~LUPIN LTD
RABEPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~RABEPRAZOLE SODIUM~MYLAN PHARMS
INC~20MG~A~076885~001~AB~Nov 8, 2013~No~RX~MYLAN PHARMACEUTICALS INC
RABEPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~RABEPRAZOLE SODIUM~TEVA PHARMS U
SA~20MG~A~076822~001~AB~Nov 8, 2013~No~RX~TEVA PHARMACEUTICALS USA INC
RABEPRAZOLE SODIUM~TABLET, DELAYED RELEASE;ORAL~RABEPRAZOLE SODIUM~TORRENT PHARM
S LTD~20MG~A~202376~001~AB~Nov 8, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
PREDNISONE~TABLET, DELAYED RELEASE;ORAL~RAYOS~HORIZON PHARMA~1MG~N~202020~001~~J
ul 26, 2012~No~RX~HORIZON PHARMA INC
ul 26, 2012~No~RX~HORIZON PHARMA INC
ul 26, 2012~Yes~RX~HORIZON PHARMA INC
ERYTHROMYCIN~TABLET, DELAYED RELEASE;ORAL~ROBIMYCIN~ROBINS AH~250MG~A~061633~001
~~Approved Prior to Jan 1, 1982~No~DISCN~AH ROBINS CO
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~STILBESTROL~TABLICAPS~0.5MG~A~08
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~STILBESTROL~TABLICAPS~1MG~A~0830
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~STILBESTROL~TABLICAPS~5MG~A~0830
DIETHYLSTILBESTROL~TABLET, DELAYED RELEASE;ORAL~STILBETIN~BRISTOL MYERS SQUIBB~0
.1MG~N~004056~011~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
.5MG~N~004056~012~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
MG~N~004056~013~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB

MG~N~004056~014~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
SULFASALAZINE~TABLET, DELAYED RELEASE;ORAL~SULFASALAZINE~VINTAGE PHARMS~500MG~A~
075339~001~AB~Jan 11, 2002~No~RX~VINTAGE PHARMACEUTICALS INC
SULFASALAZINE~TABLET, DELAYED RELEASE;ORAL~SULFASALAZINE~WATSON LABS~500MG~A~088
052~001~~May 24, 1983~No~DISCN~WATSON LABORATORIES INC
ESOMEPRAZOLE MAGNESIUM; NAPROXEN~TABLET, DELAYED RELEASE;ORAL~VIMOVO~HORIZON PHA
RMA~EQ 20MG BASE;375MG~N~022511~002~AB~Apr 30, 2010~No~RX~HORIZON PHARMA INC
ESOMEPRAZOLE MAGNESIUM; NAPROXEN~TABLET, DELAYED RELEASE;ORAL~VIMOVO~HORIZON PHA
RMA~EQ 20MG BASE;500MG~N~022511~001~AB~Apr 30, 2010~Yes~RX~HORIZON PHARMA INC
DICLOFENAC SODIUM~TABLET, DELAYED RELEASE;ORAL~VOLTAREN~NOVARTIS~25MG~N~019201~0
01~~Jul 28, 1988~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
METHADONE HYDROCHLORIDE~TABLET, DISPERSIBLE;ORAL~WESTADONE~SANDOZ~2.5MG~N~017108
~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
ALENDRONATE SODIUM~TABLET, EFFERVESCENT;ORAL~BINOSTO~MISSION PHARMA~EQ 70MG BASE
~N~202344~001~~Mar 12, 2012~Yes~RX~MISSION PHARMACAL CO
METHADONE HYDROCHLORIDE~TABLET, EFFERVESCENT;ORAL~WESTADONE~SANDOZ~5MG~N~017108~
METHADONE HYDROCHLORIDE~TABLET, EFFERVESCENT;ORAL~WESTADONE~SANDOZ~10MG~N~017108
METHADONE HYDROCHLORIDE~TABLET, EFFERVESCENT;ORAL~WESTADONE~SANDOZ~40MG~N~017108
RANITIDINE HYDROCHLORIDE~TABLET, EFFERVESCENT;ORAL~ZANTAC 150~GLAXO GRP LTD~EQ 1
50MG BASE~N~020251~001~~Mar 31, 1994~No~DISCN~GLAXO GROUP LTD ENGLAND DBA GLAXOS
MITHKLINE
RANITIDINE HYDROCHLORIDE~TABLET, EFFERVESCENT;ORAL~ZANTAC 25~GLAXO GRP LTD~EQ 25
MG BASE~N~020251~003~~Apr 1, 2004~No~DISCN~GLAXO GROUP LTD ENGLAND DBA GLAXOSMIT
HKLINE
RANITIDINE HYDROCHLORIDE~TABLET, EFFERVESCENT;ORAL~ZANTAC 75~BOEHRINGER INGELHEI
M~EQ 75MG BASE **Federal Register determination that product was not discontinue
d or withdrawn for safety or efficacy reasons**~N~020745~001~~Feb 26, 1998~No~DI
SCN~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
TESTOSTERONE~TABLET, EXTENDED RELEASE;BUCCAL~STRIANT~AUXILIUM PHARMS LLC~30MG~N~
021543~001~~Jun 19, 2003~Yes~RX~AUXILIUM PHARMACEUTICALS LLC
ASPIRIN~TABLET, EXTENDED RELEASE;ORAL~8-HOUR BAYER~BAYER~650MG~N~016030~001~~App
roved Prior to Jan 1, 1982~No~DISCN~BAYER HEALTHCARE LLC
ACETAMINOPHEN~TABLET, EXTENDED RELEASE;ORAL~ACETAMINOPHEN~OHM LABS~650MG~A~07620
0~001~~Mar 19, 2002~No~OTC~OHM LABORATORIES INC
ACETAMINOPHEN~TABLET, EXTENDED RELEASE;ORAL~ACETAMINOPHEN~PERRIGO~650MG~A~075077
~001~~Feb 25, 2000~No~OTC~L PERRIGO CO
ACETAMINOPHEN~TABLET, EXTENDED RELEASE;ORAL~ACETAMINOPHEN~RANBAXY~650MG~A~090205
~001~~Nov 18, 2009~No~DISCN~RANBAXY INC
ACETAMINOPHEN~TABLET, EXTENDED RELEASE;ORAL~ACETAMINOPHEN~RANBAXY LABS LTD~650MG
~A~078569~001~~Dec 14, 2011~No~OTC~RANBAXY LABORATORIES LTD
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORA
L~ACTOPLUS MET XR~TAKEDA PHARMS USA~1GM;EQ 15MG BASE~N~022024~001~~May 12, 2009~
No~RX~TAKEDA PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORA
L~ACTOPLUS MET XR~TAKEDA PHARMS USA~1GM;EQ 30MG BASE~N~022024~002~~May 12, 2009~
Yes~RX~TAKEDA PHARMACEUTICALS USA INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~ADALAT CC~BAYER HLTHCARE~30MG~N~020198~
001~AB1~Apr 21, 1993~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
002~AB1~Apr 21, 1993~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
003~AB1~Apr 21, 1993~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC

LOVASTATIN; NIACIN~TABLET, EXTENDED RELEASE;ORAL~ADVICOR~ABBVIE~20MG;1GM~N~02124
9~003~~Dec 17, 2001~Yes~RX~ABBVIE INC
LOVASTATIN; NIACIN~TABLET, EXTENDED RELEASE;ORAL~ADVICOR~ABBVIE~20MG;500MG~N~021
LOVASTATIN; NIACIN~TABLET, EXTENDED RELEASE;ORAL~ADVICOR~ABBVIE~20MG;750MG~N~021
LOVASTATIN; NIACIN~TABLET, EXTENDED RELEASE;ORAL~ADVICOR~ABBVIE~40MG;1GM~N~02124
9~004~~Apr 27, 2006~Yes~RX~ABBVIE INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~AFEDITAB CR~WATSON LABS~30MG~A~075128~0
01~AB1~Mar 10, 2000~No~RX~WATSON LABORATORIES INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~AFEDITAB CR~WATSON LABS~60MG~A~075659~0
01~AB1~Oct 26, 2001~No~RX~WATSON LABORATORIES INC
PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~AFRINOL~SCHERING PLOUGH~12
0MG~N~018191~001~~Approved Prior to Jan 1, 1982~Yes~OTC~SCHERING PLOUGH HEALTHCA
RE PRODUCTS INC
ALBUTEROL SULFATE~TABLET, EXTENDED RELEASE;ORAL~ALBUTEROL SULFATE~MYLAN~EQ 4MG B
ASE~A~078092~002~AB~Jan 29, 2007~No~RX~MYLAN PHARMACEUTICALS INC
ALBUTEROL SULFATE~TABLET, EXTENDED RELEASE;ORAL~ALBUTEROL SULFATE~MYLAN~EQ 8MG B
ASE~A~078092~001~AB~Jan 29, 2007~No~RX~MYLAN PHARMACEUTICALS INC
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALE
VE-D SINUS & COLD~BAYER~200MG;120MG~N~021076~001~~Nov 29, 1999~Yes~OTC~BAYER HEA
LTHCARE LLC
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALFUZOSIN HYDROCHLORIDE~AP
OTEX INC~10MG~A~079013~001~AB~Jul 18, 2011~No~RX~APOTEX INC
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALFUZOSIN HYDROCHLORIDE~AU
ROBINDO PHARMA LTD~10MG~A~079060~001~AB~Aug 30, 2012~No~RX~AUROBINDO PHARMA LTD
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALFUZOSIN HYDROCHLORIDE~IN
VAGEN PHARMS~10MG~A~090284~001~AB~Jan 17, 2012~No~RX~INVAGEN PHARMACEUTICALS INC
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALFUZOSIN HYDROCHLORIDE~MY
LAN~10MG~A~079014~001~AB~Jul 18, 2011~No~RX~MYLAN PHARMACEUTICALS INC
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALFUZOSIN HYDROCHLORIDE~SU
N PHARMA GLOBAL~10MG~A~079057~001~AB~Jul 18, 2011~No~RX~SUN PHARMA GLOBAL INC
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALFUZOSIN HYDROCHLORIDE~TE
VA PHARMS~10MG~A~079056~001~AB~Jul 18, 2011~No~RX~TEVA PHARMACEUTICALS USA
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALFUZOSIN HYDROCHLORIDE~TO
RRENT PHARMS~10MG~A~079054~001~AB~Jul 18, 2011~No~RX~TORRENT PHARMACEUTICALS LTD
.
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ALFUZOSIN HYDROCHLORIDE~WO
CKHARDT LTD~10MG~A~090221~001~~Aug 10, 2012~No~DISCN~WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEA
SE;ORAL~ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION~SANOFI AVENTIS US~60MG;120MG~N~
020786~002~~Jan 24, 2011~Yes~OTC~SANOFI AVENTIS US LLC
SE;ORAL~ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION~SANOFI AVENTIS US~180MG;240MG~N
~021704~002~~Jan 24, 2011~Yes~OTC~SANOFI AVENTIS US LLC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~0.5MG~A~07
8056~001~AB~Feb 13, 2007~No~RX~ACTAVIS ELIZABETH LLC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~1MG~A~0780
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ACTAVIS LABS FL INC~0.5MG~A~
077198~001~AB~May 13, 2010~No~RX~ACTAVIS LABORATORIES FL INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ACTAVIS LABS FL INC~1MG~A~07

ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~AMNEAL PHARMS NY~0.5MG~A~078
387~001~AB~May 30, 2008~No~RX~AMNEAL PHARMACEUTICALS NY LLC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~AMNEAL PHARMS NY~1MG~A~07838
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ANCHEN PHARMS~0.5MG~A~078469
~001~AB~Sep 29, 2011~No~RX~ANCHEN PHARMACEUTICALS, INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ANCHEN PHARMS~1MG~A~078469~0
02~AB~Sep 29, 2011~No~RX~ANCHEN PHARMACEUTICALS, INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ANI PHARMS INC~0.5MG~A~07772
5~001~AB~Jul 31, 2006~No~RX~ANI PHARMACEUTICALS INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ANI PHARMS INC~0.5MG~A~07797
9~001~~Feb 28, 2007~No~DISCN~ANI PHARMACEUTICALS INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ANI PHARMS INC~1MG~A~077725~
002~AB~Jul 31, 2006~No~RX~ANI PHARMACEUTICALS INC
002~~Feb 28, 2007~No~DISCN~ANI PHARMACEUTICALS INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~APOTEX INC~0.5MG~A~078449~00
1~AB~Nov 12, 2008~No~RX~APOTEX INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~APOTEX INC~2MG~A~078449~002~
AB~Nov 12, 2008~No~RX~APOTEX INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~APOTEX INC~3MG~A~078449~003~
AB~Nov 12, 2008~No~RX~APOTEX INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~AUROBINDO PHARMA USA~0.5MG~A
~090871~001~AB~Jun 7, 2011~No~RX~AUROBINDO PHARMA USA INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~AUROBINDO PHARMA USA~1MG~A~0
90871~002~AB~Jun 7, 2011~No~RX~AUROBINDO PHARMA USA INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~COREPHARMA~0.5MG~A~077996~00
1~AB~Jan 31, 2007~No~RX~COREPHARMA LLC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~COREPHARMA~1MG~A~077996~002~
AB~Jan 31, 2007~No~RX~COREPHARMA LLC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~IMPAX LABS~0.5MG~A~077968~00
4~AB~May 24, 2007~No~RX~IMPAX LABORATORIES INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~IMPAX LABS~1MG~A~077968~003~
AB~May 24, 2007~No~RX~IMPAX LABORATORIES INC

ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~MYLAN~0.5MG~A~077391~002~AB~
Jan 26, 2006~No~RX~MYLAN PHARMACEUTICALS INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~MYLAN~1MG~A~077391~003~AB~Ja
n 26, 2006~No~RX~MYLAN PHARMACEUTICALS INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~SANDOZ INC~0.5MG~A~077777~00
1~~Jun 30, 2006~No~DISCN~SANDOZ INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~SANDOZ INC~1MG~A~077777~002~
~Jun 30, 2006~No~DISCN~SANDOZ INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~VINTAGE PHARMS~0.5MG~A~07844
2~001~~Oct 15, 2007~No~DISCN~VINTAGE PHARMACEUTICALS
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~VINTAGE PHARMS~1MG~A~078442~
002~~Oct 15, 2007~No~DISCN~VINTAGE PHARMACEUTICALS
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ZYDUS PHARMS USA INC~0.5MG~A
~078489~001~AB~Oct 17, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~ALPRAZOLAM~ZYDUS PHARMS USA INC~1MG~A~0
78489~002~AB~Oct 17, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
LOVASTATIN~TABLET, EXTENDED RELEASE;ORAL~ALTOPREV~ANDRX LABS LLC~10MG~N~021316~0
01~~Jun 26, 2002~No~DISCN~ANDRX LABS LLC
02~~Jun 26, 2002~No~RX~ANDRX LABS LLC
03~~Jun 26, 2002~No~RX~ANDRX LABS LLC
04~~Jun 26, 2002~Yes~RX~ANDRX LABS LLC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~AMBIEN CR~SANOFI AVENTIS US~6.25
MG~N~021774~002~AB~Sep 2, 2005~No~RX~SANOFI AVENTIS US LLC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~AMBIEN CR~SANOFI AVENTIS US~12.5
MG~N~021774~001~AB~Sep 2, 2005~Yes~RX~SANOFI AVENTIS US LLC
AMOXICILLIN; CLAVULANATE POTASSIUM~TABLET, EXTENDED RELEASE;ORAL~AMOXICILLIN AND
CLAVULANATE POTASSIUM~SANDOZ~1GM;EQ 62.5MG BASE~A~090227~001~AB~Apr 21, 2010~No
~RX~SANDOZ INC
DALFAMPRIDINE~TABLET, EXTENDED RELEASE;ORAL~AMPYRA~ACORDA~10MG~N~022250~001~~Jan
22, 2010~Yes~RX~ACORDA THERAPEUTICS INC
BUPROPION HYDROBROMIDE~TABLET, EXTENDED RELEASE;ORAL~APLENZIN~VALEANT PHARMS NOR
TH~174MG~N~022108~001~~Apr 23, 2008~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA
LLC
TH~348MG~N~022108~002~~Apr 23, 2008~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA
LLC
TH~522MG~N~022108~003~~Apr 23, 2008~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA

LLC
AMOXICILLIN; CLAVULANATE POTASSIUM~TABLET, EXTENDED RELEASE;ORAL~AUGMENTIN XR~DR
REDDYS LABS INC~1GM;EQ 62.5MG BASE~N~050785~001~AB~Sep 25, 2002~Yes~RX~DR REDDY
S LABORATORIES INC
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BEN
DECTIN~SANOFI AVENTIS US~10MG;10MG **Federal Register determination that product
was not discontinued or withdrawn for safety or efficacy reasons**~N~010598~002
CLARITHROMYCIN~TABLET, EXTENDED RELEASE;ORAL~BIAXIN XL~ABBVIE~500MG~N~050775~001
~~Mar 3, 2000~No~DISCN~ABBVIE INC
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORA
L~BROMPHERIL~COPLEY PHARM~6MG;120MG~A~089116~001~~Jan 22, 1987~No~DISCN~COPLEY P
HARMACEUTICAL INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~AC
TAVIS~150MG~A~077475~001~AB2~Mar 12, 2008~No~RX~ACTAVIS SOUTHATLANTIC LLC
TAVIS LABS FL INC~100MG~A~079095~001~AB1~Mar 24, 2009~No~RX~ACTAVIS LABORATORIES
FL INC
TAVIS LABS FL INC~150MG~A~077715~001~AB3~Nov 26, 2008~No~RX~ACTAVIS LABORATORIES
FL INC
FL INC
FL INC
FL INC
TAVIS LABS FL INC~300MG~A~077715~002~~Jun 13, 2007~No~DISCN~ACTAVIS LABORATORIES
FL INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~AN
CHEN PHARMS~100MG~A~091459~001~AB1~Jun 9, 2011~No~RX~ANCHEN PHARMACEUTICALS INC
CHEN PHARMS~150MG~A~077284~001~AB3~Dec 14, 2006~No~RX~ANCHEN PHARMACEUTICALS INC
CHEN PHARMS~300MG~A~077284~002~AB3~Dec 14, 2006~No~RX~ANCHEN PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~IM
PAX LABS~100MG~A~075913~001~AB1~Jan 28, 2004~No~RX~IMPAX LABORATORIES INC
PAX LABS~150MG~A~075913~002~AB1~Mar 22, 2004~No~RX~IMPAX LABORATORIES INC
PAX LABS~150MG~A~075914~001~AB2~May 27, 2004~No~RX~IMPAX LABORATORIES INC
PAX LABS~150MG~A~077415~001~AB3~Nov 26, 2008~No~RX~IMPAX LABORATORIES INC
PAX LABS~200MG~A~076711~001~AB1~Dec 3, 2004~No~RX~IMPAX LABORATORIES INC
PAX LABS~300MG~A~077415~002~~Dec 15, 2006~No~DISCN~IMPAX LABORATORIES INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~JU
BILANT GENERICS~100MG~A~202774~001~AB1~Oct 11, 2013~No~RX~JUBILANT GENERICS LTD

BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~MY
LAN~100MG~A~090325~001~AB1~Apr 8, 2010~No~RX~MYLAN PHARMACEUTICALS INC
LAN~150MG~A~090941~001~AB2~May 3, 2010~No~RX~MYLAN PHARMACEUTICALS INC
LAN~150MG~A~090942~001~AB3~Jul 14, 2010~No~RX~MYLAN PHARMACEUTICALS INC
LAN~300MG~A~090942~002~AB3~Jul 14, 2010~No~RX~MYLAN PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~SA
NDOZ~100MG~A~075932~001~AB1~Nov 25, 2003~No~RX~SANDOZ INC
NDOZ~100MG~A~076845~001~~Jul 14, 2005~No~DISCN~SANDOZ INC
NDOZ~150MG~A~075932~002~AB1~Mar 22, 2004~No~RX~SANDOZ INC
NDOZ~200MG~A~075932~003~AB1~Jun 22, 2005~No~RX~SANDOZ INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~SU
N PHARMA GLOBAL~100MG~A~078866~001~AB1~Apr 6, 2010~No~RX~SUN PHARMA GLOBAL FZE
N PHARMA GLOBAL~150MG~A~200695~001~AB3~Dec 18, 2014~No~RX~SUN PHARMA GLOBAL FZE
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~TO
RRENT PHARMS LTD~100MG~A~203969~001~AB1~Oct 31, 2014~No~RX~TORRENT PHARMACEUTICA
LS LTD
LS LTD
LS LTD
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~WA
TSON LABS INC~100MG~A~077455~001~AB1~Jul 19, 2010~No~RX~WATSON LABORATORIES INC
TSON LABS INC~150MG~A~077285~001~AB3~Nov 26, 2008~No~RX~WATSON LABORATORIES INC
TSON LABS INC~150MG~A~077455~002~AB1~Mar 12, 2008~No~RX~WATSON LABORATORIES INC
TSON LABS INC~200MG~A~077455~003~AB1~Jul 19, 2010~No~RX~WATSON LABORATORIES INC
TSON LABS INC~300MG~A~077285~002~AB3~Aug 15, 2008~No~RX~WATSON LABORATORIES INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~WO
CKHARDT LTD~100MG~A~201331~001~AB1~Aug 30, 2012~No~RX~WOCKHARDT LTD

CKHARDT LTD~150MG~A~202189~001~AB3~Nov 21, 2012~No~RX~WOCKHARDT LTD
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~BUPROPION HYDROCHLORIDE~ZY
DUS PHARMS USA INC~300MG~A~201567~001~AB3~Jan 17, 2014~No~RX~ZYDUS PHARMACEUTICA
LS USA INC
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CALAN SR~PFIZER~120MG~N~01
9152~003~AB~Mar 6, 1991~Yes~RX~PFIZER INC
9152~002~AB~Dec 15, 1989~Yes~RX~PFIZER INC
9152~001~AB~Dec 16, 1986~Yes~RX~PFIZER INC
CARBAMAZEPINE~TABLET, EXTENDED RELEASE;ORAL~CARBAMAZEPINE~TARO~100MG~A~078115~00
1~AB~Mar 31, 2009~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~ACCORD
HLTHCARE~25MG;100MG~A~202323~001~AB~Feb 8, 2013~No~RX~ACCORD HEALTHCARE INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~ACCORD
HLTHCARE~50MG;200MG~A~202323~002~AB~Feb 8, 2013~No~RX~ACCORD HEALTHCARE INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~APOTEX~
25MG;100MG~A~076212~001~AB~Jun 16, 2004~No~RX~APOTEX INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~APOTEX~
50MG;200MG~A~076212~002~AB~Jun 16, 2004~No~RX~APOTEX INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~IMPAX L
ABS~25MG;100MG~A~076521~001~AB~May 14, 2004~No~RX~IMPAX LABORATORIES INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~IMPAX L
ABS~50MG;200MG~A~076521~002~AB~May 14, 2004~No~RX~IMPAX LABORATORIES INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~KV PHAR
M~50MG;200MG~A~076663~001~~Jun 24, 2004~No~DISCN~KV PHARMACEUTICAL CO
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~MYLAN~2
5MG;100MG~A~075091~002~AB~Apr 21, 2000~No~RX~MYLAN PHARMACEUTICALS INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~MYLAN~5
0MG;200MG~A~075091~001~AB~Sep 30, 1999~No~RX~MYLAN PHARMACEUTICALS INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~SUN PHA
RM INDS~25MG;100MG~A~077828~001~AB~Aug 23, 2007~No~RX~SUN PHARMACEUTICAL INDUSTR
IES LTD
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~CARBIDOPA AND LEVODOPA~SUN PHA
RM INDS~50MG;200MG~A~077828~002~AB~Aug 23, 2007~No~RX~SUN PHARMACEUTICAL INDUSTR
IES LTD
DILTIAZEM HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CARDIZEM LA~VALEANT INTL~1
20MG~N~021392~001~AB~Feb 6, 2003~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
20MG~N~021392~006~AB~Feb 6, 2003~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
DOXAZOSIN MESYLATE~TABLET, EXTENDED RELEASE;ORAL~CARDURA XL~PFIZER~EQ 4MG BASE~N
~021269~001~~Feb 22, 2005~No~RX~PFIZER INC
DOXAZOSIN MESYLATE~TABLET, EXTENDED RELEASE;ORAL~CARDURA XL~PFIZER~EQ 8MG BASE~N
~021269~002~~Feb 22, 2005~Yes~RX~PFIZER INC
CEFACLOR~TABLET, EXTENDED RELEASE;ORAL~CECLOR CD~LILLY~EQ 375MG BASE~N~050673~00

CEFACLOR~TABLET, EXTENDED RELEASE;ORAL~CECLOR CD~LILLY~EQ 500MG BASE~N~050673~00
CEFACLOR~TABLET, EXTENDED RELEASE;ORAL~CEFACLOR~TEVA~EQ 375MG BASE~A~065058~001~
~Sep 4, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
CEFACLOR~TABLET, EXTENDED RELEASE;ORAL~CEFACLOR~TEVA~EQ 500MG BASE~A~065058~002~
~Sep 4, 2002~Yes~RX~TEVA PHARMACEUTICALS USA INC
CEFACLOR~TABLET, EXTENDED RELEASE;ORAL~CEFACLOR~WORLD GEN~EQ 500MG BASE~A~065057
~001~~Jan 5, 2001~No~DISCN~WORLD GEN LLC
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE
;ORAL~CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~IVAX SUB TEVA P
HARMS~5MG;120MG~A~077170~001~~Feb 25, 2008~No~OTC~IVAX PHARMACEUTICALS INC SUB T
;ORAL~CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~SANDOZ~5MG;120M
G~A~077991~001~~Mar 5, 2008~No~OTC~SANDOZ INC
;ORAL~CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~SUN PHARM INDS
LTD~5MG;120MG~A~090922~001~~Sep 28, 2012~No~OTC~SUN PHARMACEUTICAL INDUSTRIES LT
D
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~
CHLOR-TRIMETON~SCHERING PLOUGH~8MG;120MG~N~018397~001~~Approved Prior to Jan 1,
1982~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
CHLORPHENIRAMINE MALEATE~TABLET, EXTENDED RELEASE;ORAL~CHLOR-TRIMETON~SCHERING P
LOUGH~8MG~N~007638~001~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING PLOUGH H
EALTHCARE PRODUCTS INC
CHLORPHENIRAMINE MALEATE~TABLET, EXTENDED RELEASE;ORAL~CHLOR-TRIMETON~SCHERING P
LOUGH~12MG~N~007638~002~~Approved Prior to Jan 1, 1982~Yes~OTC~SCHERING PLOUGH H
EALTHCARE PRODUCTS INC
CHLORPHENIRAMINE MALEATE~TABLET, EXTENDED RELEASE;ORAL~CHLORPHENIRAMINE MALEATE~
AVANTHI INC~12MG~A~040829~001~~May 13, 2009~No~OTC~AVANTHI INC
OXTRIPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~CHOLEDYL SA~WARNER CHILCOTT LLC~400M
G~A~087863~001~~May 24, 1983~Yes~RX~WARNER CHILCOTT CO LLC
OXTRIPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~CHOLEDYL SA~WARNER CHILCOTT LLC~600M
G~A~086742~001~~Approved Prior to Jan 1, 1982~Yes~RX~WARNER CHILCOTT CO LLC
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CIPRO X
R~BAYER HLTHCARE~212.6MG;EQ 287.5MG BASE~N~021473~001~~Dec 13, 2002~No~DISCN~BAY
ER HEALTHCARE PHARMACEUTICALS INC
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CIPRO X
R~BAYER HLTHCARE~425.2MG;EQ 574.9MG BASE~N~021473~002~~Aug 28, 2003~No~DISCN~BAY
ER HEALTHCARE PHARMACEUTICALS INC
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CIPROFL
OXACIN EXTENDED RELEASE~ACTAVIS LABS FL INC~212.6MG;EQ 287.5MG BASE~A~077417~001
~AB~Nov 30, 2010~No~RX~ACTAVIS LABORATORIES FL INC
OXACIN EXTENDED RELEASE~ACTAVIS LABS FL INC~425.2MG;EQ 574.9MG BASE~A~077809~001
~AB~Nov 30, 2010~No~RX~ACTAVIS LABORATORIES FL INC
OXACIN EXTENDED RELEASE~ANCHEN PHARMS~212.6MG;EQ 287.5MG BASE~A~078166~002~AB~No
v 27, 2007~No~RX~ANCHEN PHARMACEUTICALS, INC
OXACIN EXTENDED RELEASE~ANCHEN PHARMS~425.2MG;EQ 574.9MG BASE~A~078166~001~AB~No
v 27, 2007~No~RX~ANCHEN PHARMACEUTICALS, INC
OXACIN EXTENDED RELEASE~DR REDDYS LABS LTD~212.6MG;EQ 287.5MG BASE~A~077701~002~
~Oct 31, 2007~No~DISCN~DR REDDYS LABORATORIES LTD
OXACIN EXTENDED RELEASE~DR REDDYS LABS LTD~425.2MG;EQ 574.9MG BASE~A~077701~001~
AB~Mar 26, 2007~No~RX~DR REDDYS LABORATORIES LTD

OXACIN EXTENDED RELEASE~MYLAN PHARMS INC~212.6MG;EQ 287.5MG BASE~A~078183~001~AB
~Mar 22, 2007~Yes~RX~MYLAN PHARMACEUTICALS INC
OXACIN EXTENDED RELEASE~MYLAN PHARMS INC~425.2MG;EQ 574.9MG BASE~A~078183~002~AB
~Mar 22, 2007~Yes~RX~MYLAN PHARMACEUTICALS INC
OXACIN EXTENDED RELEASE~SANDOZ~212.6MG;EQ 287.5MG BASE~A~078712~001~~Dec 11, 200
DESLORATADINE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~CLARINEX D
24 HOUR~MERCK SHARP DOHME~5MG;240MG~N~021605~001~AB~Mar 3, 2005~Yes~RX~MERCK SHA
RP AND DOHME CORP
DESLORATADINE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~CLARINEX-D
12 HOUR~MERCK SHARP DOHME~2.5MG;120MG~N~021313~001~~Feb 1, 2006~Yes~RX~MERCK SHA
RP AND DOHME CORP
CLARITHROMYCIN~TABLET, EXTENDED RELEASE;ORAL~CLARITHROMYCIN~ACTAVIS LABS FL INC~
500MG~A~065145~001~AB~Jun 24, 2004~No~RX~ACTAVIS LABORATORIES FL INC
CLARITHROMYCIN~TABLET, EXTENDED RELEASE;ORAL~CLARITHROMYCIN~RANBAXY~1GM~A~065210
~001~~Jan 26, 2005~No~DISCN~RANBAXY LABORATORIES LTD
CLARITHROMYCIN~TABLET, EXTENDED RELEASE;ORAL~CLARITHROMYCIN~SANDOZ~500MG~A~06525
0~001~~Aug 25, 2005~No~DISCN~SANDOZ
CLARITHROMYCIN~TABLET, EXTENDED RELEASE;ORAL~CLARITHROMYCIN~TEVA~500MG~A~065154~
001~AB~May 18, 2005~Yes~RX~TEVA PHARMACEUTICALS USA INC
LORATADINE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~CLARITIN-D~SCH
ERING PLOUGH~5MG;120MG~N~019670~002~~Nov 27, 2002~Yes~OTC~SCHERING PLOUGH HEALTH
CARE PRODUCTS INC
LORATADINE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~CLARITIN-D 24
HOUR~SCHERING PLOUGH~10MG;240MG~N~020470~002~~Nov 27, 2002~Yes~OTC~SCHERING PLOU
GH HEALTHCARE PRODUCTS INC
CLONIDINE~TABLET, EXTENDED RELEASE;ORAL~CLONIDINE~TRIS PHARMA INC~EQ 0.17MG BASE
~N~022500~001~~Dec 3, 2009~No~DISCN~TRIS PHARMA INC
CLONIDINE~TABLET, EXTENDED RELEASE;ORAL~CLONIDINE~TRIS PHARMA INC~EQ 0.26MG BASE
~N~022500~002~~Dec 3, 2009~No~DISCN~TRIS PHARMA INC
CLONIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CLONIDINE HYDROCHLORIDE~AN
CHEN PHARMS~0.1MG~A~202983~001~AB~Apr 2, 2014~No~RX~ANCHEN PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CLONIDINE HYDROCHLORIDE~AN
CHEN PHARMS~0.2MG~A~202983~002~AB~Apr 2, 2014~No~RX~ANCHEN PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CLONIDINE HYDROCHLORIDE ~A
NCHEN PHARMS~0.1MG~A~202984~001~AB~Sep 30, 2013~No~RX~ANCHEN PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CLONIDINE HYDROCHLORIDE ~A
NCHEN PHARMS~0.2MG~A~202984~002~AB~Sep 30, 2013~No~RX~ANCHEN PHARMACEUTICALS INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~CONCERTA~JANSSEN PHA
RMS~18MG~N~021121~001~~Aug 1, 2000~No~RX~JANSSEN PHARMACEUTICALS INC
RMS~27MG~N~021121~004~~Apr 1, 2002~No~RX~JANSSEN PHARMACEUTICALS INC
RMS~36MG~N~021121~002~~Aug 1, 2000~No~RX~JANSSEN PHARMACEUTICALS INC
RMS~54MG~N~021121~003~~Dec 8, 2000~Yes~RX~JANSSEN PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~
CONTRAVE~TAKEDA PHARMS USA~90MG;8MG~N~200063~001~~Sep 10, 2014~Yes~RX~TAKEDA PHA
RMACEUTICALS USA INC
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~COVERA-HS~GD SEARLE LLC~18
0MG~N~020552~001~BC~Feb 26, 1996~Yes~RX~GD SEARLE LLC
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~COVERA-HS~GD SEARLE LLC~24
0MG~N~020552~002~BC~Feb 26, 1996~Yes~RX~GD SEARLE LLC
INDECAINIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DECABID~LILLY~EQ 50MG BA
SE~N~019693~001~~Dec 29, 1989~No~DISCN~ELI LILLY AND CO
INDECAINIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DECABID~LILLY~EQ 75MG BA
SE~N~019693~002~~Dec 29, 1989~No~DISCN~ELI LILLY AND CO
INDECAINIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DECABID~LILLY~EQ 100MG B

ASE~N~019693~003~~Dec 29, 1989~No~DISCN~ELI LILLY AND CO
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DEPAKOTE ER~ABBVIE~EQ 250MG VALP
ROIC ACID~N~021168~002~AB~May 31, 2002~No~RX~ABBVIE INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DEPAKOTE ER~ABBVIE~EQ 500MG VALP
ROIC ACID~N~021168~001~AB~Aug 4, 2000~Yes~RX~ABBVIE INC
DESLORATADINE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~DESLORATADI
NE AND PSEUDOEPHEDRINE SULFATE 24 HOUR~DR REDDYS LABS LTD~5MG;240MG~A~078366~001
~AB~Apr 26, 2011~No~RX~DR REDDYS LABORATORIES LTD
METHAMPHETAMINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DESOXYN~RECORDATI RA
RE~5MG~N~005378~004~~Approved Prior to Jan 1, 1982~No~DISCN~RECORDATI RARE DISEA
SES INC
RE~10MG~N~005378~003~~Approved Prior to Jan 1, 1982~No~DISCN~RECORDATI RARE DISE
ASES INC
RE~15MG~N~005378~005~~Approved Prior to Jan 1, 1982~No~DISCN~RECORDATI RARE DISE
ASES INC
DESVENLAFAXINE~TABLET, EXTENDED RELEASE;ORAL~DESVENLAFAXINE~ALEMBIC PHARMS LTD~5
0MG~N~204150~001~BC~Mar 4, 2013~Yes~RX~ALEMBIC PHARMACEUTICALS LTD
DESVENLAFAXINE~TABLET, EXTENDED RELEASE;ORAL~DESVENLAFAXINE~ALEMBIC PHARMS LTD~1
00MG~N~204150~002~BC~Mar 4, 2013~Yes~RX~ALEMBIC PHARMACEUTICALS LTD
DESVENLAFAXINE FUMARATE~TABLET, EXTENDED RELEASE;ORAL~DESVENLAFAXINE~SUN PHARMA
GLOBAL~EQ 50MG BASE~N~205583~001~~Jan 28, 2014~Yes~RX~SUN PHARMA GLOBAL FZE
DESVENLAFAXINE FUMARATE~TABLET, EXTENDED RELEASE;ORAL~DESVENLAFAXINE~SUN PHARMA
GLOBAL~EQ 100MG BASE~N~205583~002~~Jan 28, 2014~Yes~RX~SUN PHARMA GLOBAL FZE
DESVENLAFAXINE FUMARATE~TABLET, EXTENDED RELEASE;ORAL~DESVENLAFAXINE~TEVA PHARMS
USA~EQ 50MG BASE~N~205208~001~~Oct 11, 2013~No~DISCN~TEVA PHARMACEUTICALS USA
DESVENLAFAXINE FUMARATE~TABLET, EXTENDED RELEASE;ORAL~DESVENLAFAXINE~TEVA PHARMS
USA~EQ 100MG BASE~N~205208~002~~Oct 11, 2013~No~DISCN~TEVA PHARMACEUTICALS USA
L~DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE~AVANTHI INC~6MG;120MG~A
~078648~001~~Feb 27, 2013~Yes~OTC~AVANTHI INC
DICLOFENAC SODIUM~TABLET, EXTENDED RELEASE;ORAL~DICLOFENAC SODIUM~ACTAVIS ELIZAB
ETH~100MG~A~075910~001~AB~Jan 7, 2002~No~RX~ACTAVIS ELIZABETH LLC
DICLOFENAC SODIUM~TABLET, EXTENDED RELEASE;ORAL~DICLOFENAC SODIUM~DEXCEL LTD~100
MG~A~076201~001~AB~Nov 6, 2002~No~RX~DEXCEL LTD
DICLOFENAC SODIUM~TABLET, EXTENDED RELEASE;ORAL~DICLOFENAC SODIUM~MYLAN~100MG~A~
DICLOFENAC SODIUM~TABLET, EXTENDED RELEASE;ORAL~DICLOFENAC SODIUM~VALEANT INTL~1
00MG~A~075492~001~AB~Feb 11, 2000~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
DIETHYLPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DIETHYLPROPION HYDROC
HLORIDE~LANNETT HOLDINGS INC~75MG~A~091680~001~AB~Oct 24, 2011~No~RX~LANNETT HOL
DINGS INC
DILTIAZEM HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~AC
TAVIS LABS FL INC~120MG~A~077686~006~AB~Mar 15, 2010~No~RX~ACTAVIS LABORATORIES
FL INC
FL INC
FL INC
FL INC
FL INC

FL INC
BROMPHENIRAMINE MALEATE~TABLET, EXTENDED RELEASE;ORAL~DIMETANE~WYETH CONS~8MG~N~
010799~010~~Jun 10, 1983~No~DISCN~WYETH CONSUMER HEALTHCARE
BROMPHENIRAMINE MALEATE~TABLET, EXTENDED RELEASE;ORAL~DIMETANE~WYETH CONS~12MG~N
~010799~011~~Jun 10, 1983~No~DISCN~WYETH CONSUMER HEALTHCARE
L~DISOBROM~SANDOZ~6MG;120MG~A~070770~001~~Sep 30, 1991~No~DISCN~SANDOZ INC
L~DISOPHROL~SCHERING PLOUGH~6MG;120MG~N~013483~004~~Sep 13, 1982~No~DISCN~SCHERI
NG PLOUGH HEALTHCARE PRODUCTS INC
OXYBUTYNIN CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DITROPAN XL~JANSSEN PHARMS~5MG
~N~020897~001~AB~Dec 16, 1998~No~RX~JANSSEN PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DITROPAN XL~JANSSEN PHARMS~10M
G~N~020897~002~AB~Dec 16, 1998~No~RX~JANSSEN PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~DITROPAN XL~JANSSEN PHARMS~15M
G~N~020897~003~AB~Jun 22, 1999~Yes~RX~JANSSEN PHARMACEUTICALS INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~ANCHEN PHARMS~
EQ 250MG VALPROIC ACID~A~078445~001~AB~Feb 26, 2009~No~RX~ANCHEN PHARMACEUTICALS
TAIWAN INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~ANCHEN PHARMS~
EQ 500MG VALPROIC ACID~A~078445~002~AB~Aug 4, 2009~No~RX~ANCHEN PHARMACEUTICALS
TAIWAN INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~AUROBINDO PHAR
MA LTD~EQ 250MG VALPROIC ACID~A~202419~001~AB~Jun 2, 2014~No~RX~AUROBINDO PHARMA
LTD
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~AUROBINDO PHAR
MA LTD~EQ 500MG VALPROIC ACID~A~202419~002~AB~Jun 2, 2014~No~RX~AUROBINDO PHARMA
LTD
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~DR REDDYS LABS
LTD~EQ 250MG VALPROIC ACID~A~090161~001~AB~Mar 15, 2012~No~RX~DR REDDYS LABORAT
ORIES LTD
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~IMPAX LABS~EQ
250MG VALPROIC ACID~A~078791~001~AB~May 6, 2009~No~RX~IMPAX LABORATORIES INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~IMPAX LABS~EQ
500MG VALPROIC ACID~A~078791~002~AB~Aug 4, 2009~No~RX~IMPAX LABORATORIES INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~MYLAN~EQ 250MG
VALPROIC ACID~A~077567~001~AB~Jan 29, 2009~No~RX~MYLAN PHARMACEUTICALS INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~MYLAN~EQ 500MG
VALPROIC ACID~A~077567~002~AB~Jan 29, 2009~No~RX~MYLAN PHARMACEUTICALS INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~REDDYS~EQ 500M
G VALPROIC ACID~A~090070~001~AB~Mar 12, 2012~No~RX~DOCTOR REDDYS LABORATORIES LT
D
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~TEVA PHARMS US
A~EQ 500MG VALPROIC ACID~A~078700~001~~Aug 3, 2009~No~DISCN~TEVA PHARMACEUTICALS
USA
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~WOCKHARDT~EQ 2
50MG VALPROIC ACID~A~078705~002~AB~Feb 10, 2009~No~RX~WOCKHARDT LTD
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~WOCKHARDT~EQ 5
00MG VALPROIC ACID~A~078705~001~AB~Aug 4, 2009~No~RX~WOCKHARDT LTD
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~ZYDUS PHARMS U
SA INC~EQ 250MG VALPROIC ACID~A~078239~001~AB~Feb 27, 2009~No~RX~ZYDUS PHARMACEU
TICALS USA INC
DIVALPROEX SODIUM~TABLET, EXTENDED RELEASE;ORAL~DIVALPROEX SODIUM~ZYDUS PHARMS U
SA INC~EQ 500MG VALPROIC ACID~A~078239~002~AB~Aug 4, 2009~No~RX~ZYDUS PHARMACEUT
ICALS USA INC
L~DRIXORAL~SCHERING PLOUGH~6MG;120MG **Federal Register determination that produ
03~~Sep 13, 1982~No~DISCN~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTEN

DED RELEASE;ORAL~DRIXORAL PLUS~SCHERING PLOUGH~500MG;3MG;60MG~N~019453~001~~May
22, 1987~No~DISCN~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~DURAPHYL~FOREST LABS~100MG~A~088503~0
01~~Apr 3, 1985~No~DISCN~FOREST LABORATORIES INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~DURAQUIN~WARNER CHILCOTT~330MG
~N~017917~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT DIV WARNER
LAMBERT CO
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~DUTOPROL
~COVIS PHARMA SARL~12.5MG;EQ 25MG TARTRATE~N~021956~001~~Aug 28, 2006~No~RX~COVI
S PHARMA SARL
~COVIS PHARMA SARL~12.5MG;EQ 50MG TARTRATE~N~021956~002~~Aug 28, 2006~No~RX~COVI
S PHARMA SARL
~COVIS PHARMA SARL~12.5MG;EQ 100MG TARTRATE~N~021956~003~~Aug 28, 2006~Yes~RX~CO
VIS PHARMA SARL
ISRADIPINE~TABLET, EXTENDED RELEASE;ORAL~DYNACIRC CR~GLAXOSMITHKLINE LLC~5MG **F
safety or efficacy reasons**~N~020336~001~~Jun 1, 1994~No~DISCN~GLAXOSMITHKLINE
LLC
ISRADIPINE~TABLET, EXTENDED RELEASE;ORAL~DYNACIRC CR~GLAXOSMITHKLINE LLC~10MG **
r safety or efficacy reasons**~N~020336~002~~Jun 1, 1994~No~DISCN~GLAXOSMITHKLIN
E LLC
CHLORPHENIRAMINE MALEATE~TABLET, EXTENDED RELEASE;ORAL~EFIDAC 24 CHLORPHENIRAMIN
E MALEATE~ALZA~16MG~N~019746~002~~Nov 18, 1994~No~DISCN~ALZA CORP
BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;
ORAL~EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE~ALZA~16MG;2
40MG~N~019672~001~~Mar 29, 1996~No~DISCN~ALZA CORP
DARIFENACIN HYDROBROMIDE~TABLET, EXTENDED RELEASE;ORAL~ENABLEX~WARNER CHILCOTT L
LC~EQ 7.5MG BASE~N~021513~001~~Dec 22, 2004~No~RX~WARNER CHILCOTT CO LLC
DARIFENACIN HYDROBROMIDE~TABLET, EXTENDED RELEASE;ORAL~ENABLEX~WARNER CHILCOTT L
LC~EQ 15MG BASE~N~021513~002~~Dec 22, 2004~Yes~RX~WARNER CHILCOTT CO LLC
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~ESKALITH CR~JDS PHARMS~450MG~N~0
18152~001~~Mar 29, 1982~No~DISCN~JDS PHARMACEUTICALS LLC
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~ACTAVIS ELIZABETH~400MG~A~075696
~001~~Jul 31, 2000~No~DISCN~ACTAVIS ELIZABETH LLC
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~SANDOZ~400MG~A~075943~001~~Jul 2
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~TARO~400MG~A~076174~001~AB~Mar 1
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~TEVA~400MG~A~075665~003~AB~Feb 5
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~TEVA~500MG~A~075665~002~AB~Jul 3
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~TEVA~600MG~A~075665~001~AB~Jul 3
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~WATSON LABS FLORIDA~400MG~A~0758

29~001~~Nov 30, 2001~No~DISCN~WATSON LABORATORIES INC FLORIDA
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~WATSON LABS FLORIDA~500MG~A~0758
29~002~~Nov 30, 2001~No~DISCN~WATSON LABORATORIES INC FLORIDA
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~ETODOLAC~ZYDUS PHARMS USA INC~400MG~A~091
134~001~AB~Jan 23, 2014~No~RX~ZYDUS PHARMACEUTICALS USA INC
HYDROMORPHONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~EXALGO~MALLINCKRODT IN
C~8MG~N~021217~001~AB~Mar 1, 2010~No~RX~MALLINCKRODT INC
C~32MG~N~021217~004~~Aug 24, 2012~Yes~RX~MALLINCKRODT INC
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~AUROBINDO PHARMA LTD~2.5MG~A
~203417~001~AB~Jan 17, 2013~No~RX~AUROBINDO PHARMA LTD
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~AUROBINDO PHARMA LTD~5MG~A~2
03417~002~AB~Jan 17, 2013~No~RX~AUROBINDO PHARMA LTD
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~AUROBINDO PHARMA LTD~10MG~A~
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~GLENMARK GENERICS~2.5MG~A~09
0365~001~AB~Dec 17, 2010~No~RX~GLENMARK GENERICS LTD
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~GLENMARK GENERICS~5MG~A~0903
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~GLENMARK GENERICS~10MG~A~090
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~HERITAGE PHARMS INC~2.5MG~A~
201964~001~AB~Nov 8, 2013~No~RX~HERITAGE PHARMACEUTICALS INC
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~HERITAGE PHARMS INC~5MG~A~20
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~HERITAGE PHARMS INC~10MG~A~2
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~MUTUAL PHARM~2.5MG~A~075896~
001~AB~Nov 2, 2004~No~RX~MUTUAL PHARMACEUTICAL CO INC
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~MUTUAL PHARM~5MG~A~075896~00
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~MUTUAL PHARM~10MG~A~075896~0
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~MYLAN~2.5MG~A~078855~001~AB~
Apr 17, 2008~No~RX~MYLAN PHARMACEUTICALS INC
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~MYLAN~5MG~A~078855~002~AB~Ap
r 17, 2008~No~RX~MYLAN PHARMACEUTICALS INC
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~MYLAN~10MG~A~078855~003~AB~A
pr 17, 2008~Yes~RX~MYLAN PHARMACEUTICALS INC
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~RANBAXY LABS LTD~2.5MG~A~091
200~001~AB~Dec 13, 2013~No~RX~RANBAXY LABORATORIES LTD
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~RANBAXY LABS LTD~5MG~A~09120
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~RANBAXY LABS LTD~10MG~A~0912
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~TORRENT PHARMS LTD~2.5MG~A~2
02170~001~AB~Nov 28, 2011~No~RX~TORRENT PHARMACEUTICALS LTD
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~TORRENT PHARMS LTD~5MG~A~202
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~TORRENT PHARMS LTD~10MG~A~20
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~VINTAGE PHARMS LLC~2.5MG~A~2

00815~001~AB~Oct 28, 2011~No~RX~VINTAGE PHARMACEUTICALS LLC
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~VINTAGE PHARMS LLC~5MG~A~200
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~VINTAGE PHARMS LLC~10MG~A~20
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~WOCKHARDT LTD~2.5MG~A~091484
~001~~Aug 15, 2012~No~DISCN~WOCKHARDT LTD
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~WOCKHARDT LTD~5MG~A~091484~0
02~~Aug 15, 2012~No~DISCN~WOCKHARDT LTD
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~FELODIPINE~WOCKHARDT LTD~10MG~A~091484~
003~~Aug 15, 2012~No~DISCN~WOCKHARDT LTD
SE;ORAL~FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~BARR~60MG;1
20MG~A~076236~001~AB~Apr 14, 2005~No~RX~BARR LABORATORIES INC
SE;ORAL~FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~DR REDDYS L
ABS LTD~60MG;120MG~A~076667~001~~Nov 18, 2014~No~OTC~DR REDDYS LABORATORIES LTD
SE;ORAL~FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~DR REDDYS L
ABS LTD~180MG;240MG~A~079043~002~~Jun 22, 2011~No~OTC~DR REDDYS LABORATORIES LTD
SE;ORAL~FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~IMPAX PHARM
S~60MG;120MG~A~076298~001~AB~Nov 12, 2010~No~RX~IMPAX PHARMACEUTICALS
SE;ORAL~FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~SUN PHARMA
GLOBAL~60MG;120MG~A~090818~001~~Jan 29, 2015~No~OTC~SUN PHARMA GLOBAL FZE
METRONIDAZOLE~TABLET, EXTENDED RELEASE;ORAL~FLAGYL ER~GD SEARLE LLC~750MG~N~0208
68~001~AB~Nov 26, 1997~Yes~RX~GD SEARLE LLC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~FORFIVO XL~EDGEMONT PHARMS
LLC~450MG~N~022497~001~~Nov 10, 2011~Yes~RX~EDGEMONT PHARMACEUTICALS LLC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~FORTAMET~ANDRX LABS LLC~1G
M~N~021574~002~AB2~Apr 27, 2004~Yes~RX~ANDRX LABS LLC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~FORTAMET~ANDRX LABS LLC~50
0MG~N~021574~001~AB2~Apr 27, 2004~No~RX~ANDRX LABS LLC
GLIPIZIDE~TABLET, EXTENDED RELEASE;ORAL~GLIPIZIDE~PAR PHARM~5MG~A~076159~002~AB~
Sep 20, 2013~No~RX~PAR PHARMACEUTICAL INC
GLIPIZIDE~TABLET, EXTENDED RELEASE;ORAL~GLIPIZIDE~PAR PHARM~10MG~A~076159~001~AB
~Sep 20, 2013~No~RX~PAR PHARMACEUTICAL INC
GLIPIZIDE~TABLET, EXTENDED RELEASE;ORAL~GLIPIZIDE~WATSON LABS~2.5MG~A~076467~003
~AB~Mar 27, 2006~No~RX~WATSON LABORATORIES INC
GLIPIZIDE~TABLET, EXTENDED RELEASE;ORAL~GLIPIZIDE~WATSON LABS~5MG~A~076467~001~A
B~Sep 8, 2003~No~RX~WATSON LABORATORIES INC
GLIPIZIDE~TABLET, EXTENDED RELEASE;ORAL~GLIPIZIDE~WATSON LABS~10MG~A~076467~002~
AB~Nov 7, 2003~No~RX~WATSON LABORATORIES INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~GLUCOPHAGE XR~BRISTOL MYER
S SQUIBB~500MG~N~021202~001~AB1~Oct 13, 2000~No~RX~BRISTOL MYERS SQUIBB CO
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~GLUCOPHAGE XR~BRISTOL MYER
S SQUIBB~750MG~N~021202~004~AB~Apr 11, 2003~Yes~RX~BRISTOL MYERS SQUIBB CO
GLIPIZIDE~TABLET, EXTENDED RELEASE;ORAL~GLUCOTROL XL~PFIZER~2.5MG~N~020329~003~A
B~Aug 10, 1999~No~RX~PFIZER INC
GLIPIZIDE~TABLET, EXTENDED RELEASE;ORAL~GLUCOTROL XL~PFIZER~5MG~N~020329~001~AB~
Apr 26, 1994~No~RX~PFIZER INC
GLIPIZIDE~TABLET, EXTENDED RELEASE;ORAL~GLUCOTROL XL~PFIZER~10MG~N~020329~002~AB
~Apr 26, 1994~Yes~RX~PFIZER INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~GLUMETZA~SANTARUS INC~1GM~
N~021748~002~~Jun 3, 2005~Yes~RX~SANTARUS INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~GLUMETZA~SANTARUS INC~500M
G~N~021748~001~~Jun 3, 2005~No~RX~SANTARUS INC
GUAIFENESIN~TABLET, EXTENDED RELEASE;ORAL~GUAIFENESIN~PERRIGO R AND D~600MG~A~07
8912~001~~Nov 23, 2011~No~OTC~PERRIGO R AND D CO

GUANFACINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~GUANFACINE HYDROCHLORIDE~
ACTAVIS ELIZABETH~EQ 1MG BASE~A~200881~001~AB~Oct 5, 2012~No~RX~ACTAVIS ELIZABET
H LLC
H LLC
H LLC
H LLC
GABAPENTIN ENACARBIL~TABLET, EXTENDED RELEASE;ORAL~HORIZANT~XENOPORT INC~300MG~N
~022399~002~~Dec 13, 2011~No~RX~XENOPORT INC
GABAPENTIN ENACARBIL~TABLET, EXTENDED RELEASE;ORAL~HORIZANT~XENOPORT INC~600MG~N
~022399~001~~Apr 6, 2011~Yes~RX~XENOPORT INC
HYDROMORPHONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~HYDROMORPHONE HYDROCHL
ORIDE~ACTAVIS LABS FL INC~8MG~A~202144~001~AB~May 12, 2014~No~RX~ACTAVIS LABORAT
ORIES FL INC
ORIDE~ACTAVIS LABS FL INC~12MG~A~202144~002~AB~May 12, 2014~No~RX~ACTAVIS LABORA
TORIES FL INC
ORIDE~ACTAVIS LABS FL INC~16MG~A~202144~003~AB~May 12, 2014~No~RX~ACTAVIS LABORA
TORIES FL INC
HYDROCODONE BITARTRATE~TABLET, EXTENDED RELEASE;ORAL~HYSINGLA~PURDUE PHARMA LP~2
0MG~N~206627~001~~Nov 20, 2014~No~RX~PURDUE PHARMA LP
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~IMDUR~SCHERING PLOUGH~30MG~
N~020225~001~~Aug 12, 1993~No~DISCN~SCHERING PLOUGH CORP
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~IMDUR~SCHERING PLOUGH~60MG~
N~020225~002~~Aug 12, 1993~No~DISCN~SCHERING PLOUGH CORP
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~IMDUR~SCHERING PLOUGH~120MG
~N~020225~003~~Mar 30, 1995~No~DISCN~SCHERING PLOUGH CORP
GUANFACINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~INTUNIV~SHIRE~EQ 1MG BASE
~N~022037~001~AB~Sep 2, 2009~No~RX~SHIRE DEVELOPMENT INC
~N~022037~004~AB~Sep 2, 2009~Yes~RX~SHIRE DEVELOPMENT INC
PALIPERIDONE~TABLET, EXTENDED RELEASE;ORAL~INVEGA~JANSSEN PHARMS~1.5MG~N~021999~
006~~Aug 26, 2008~No~RX~JANSSEN PHARMACEUTICALS INC
PALIPERIDONE~TABLET, EXTENDED RELEASE;ORAL~INVEGA~JANSSEN PHARMS~3MG~N~021999~00
1~~Dec 19, 2006~No~RX~JANSSEN PHARMACEUTICALS INC
2~~Dec 19, 2006~Yes~RX~JANSSEN PHARMACEUTICALS INC

3~~Dec 19, 2006~No~RX~JANSSEN PHARMACEUTICALS INC
PALIPERIDONE~TABLET, EXTENDED RELEASE;ORAL~INVEGA~JANSSEN PHARMS~12MG **Federal
or efficacy reasons**~N~021999~004~~Dec 19, 2006~No~DISCN~JANSSEN PHARMACEUTICA
LS INC
ISOSORBIDE DINITRATE~TABLET, EXTENDED RELEASE;ORAL~ISORDIL~WYETH AYERST~40MG~N~0
12882~001~~Jul 29, 1988~No~DISCN~WYETH AYERST LABORATORIES
ISOSORBIDE DINITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE DINITRATE~COREPHAR
MA~40MG~A~040723~001~AB~Mar 17, 2008~No~RX~COREPHARMA LLC
ISOSORBIDE DINITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE DINITRATE~SUN PHAR
M INDS INC~40MG~A~040009~001~AB~Dec 30, 1998~Yes~RX~SUN PHARMACEUTICAL INDUSTRIE
S INC
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~ACTA
VIS ELIZABETH~30MG~A~075306~001~~Dec 31, 1998~No~DISCN~ACTAVIS ELIZABETH LLC
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~ACTA
VIS ELIZABETH~60MG~A~075306~002~~Dec 31, 1998~No~DISCN~ACTAVIS ELIZABETH LLC
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~ALKE
RMES GAINESVILLE~60MG~A~075041~001~~Sep 22, 1998~No~DISCN~ALKERMES GAINESVILLE L
LC
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~DEXC
EL LTD~60MG~A~075522~001~AB~Apr 17, 2000~No~RX~DEXCEL LTD
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~HIKM
A PHARMS~30MG~A~076813~002~AB~Mar 30, 2006~No~RX~HIKMA PHARMACEUTICALS
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~HIKM
A PHARMS~60MG~A~076813~001~AB~Jan 7, 2005~No~RX~HIKMA PHARMACEUTICALS
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~IVAX
SUB TEVA PHARMS~30MG~A~075448~002~~Aug 7, 2001~No~DISCN~IVAX PHARMACEUTICALS IN
C SUB TEVA PHARMACEUTICALS USA
SUB TEVA PHARMS~60MG~A~075448~001~~Jun 19, 2000~No~DISCN~IVAX PHARMACEUTICALS I
SUB TEVA PHARMS~120MG~A~075448~003~~Aug 7, 2001~No~DISCN~IVAX PHARMACEUTICALS I
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~KREM
ERS URBAN PHARMS~30MG~A~075155~002~AB~Jan 13, 2000~No~RX~KREMERS URBAN PHARMACEU
TICALS INC
ERS URBAN PHARMS~60MG~A~075155~001~AB~Oct 30, 1998~No~RX~KREMERS URBAN PHARMACEU
TICALS INC
ERS URBAN PHARMS~120MG~A~075155~003~AB~Aug 4, 2000~Yes~RX~KREMERS URBAN PHARMACE
UTICALS INC
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~NESH
ER PHARMS~30MG~A~075395~001~AB~Mar 16, 2000~No~RX~NESHER PHARMACEUTICALS USA LLC
ER PHARMS~60MG~A~075395~002~AB~Mar 16, 2000~No~RX~NESHER PHARMACEUTICALS USA LLC
ER PHARMS~120MG~A~075395~003~AB~Mar 16, 2000~No~RX~NESHER PHARMACEUTICALS USA LL
C
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~SKYE
PHARMA AG~60MG~A~075166~001~~Oct 7, 1999~No~DISCN~SKYEPHARMA AG
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~TORR
ENT PHARMS~30MG~A~200270~001~AB~Jun 3, 2011~No~RX~TORRENT PHARMACEUTICALS LTD
ISOSORBIDE MONONITRATE~TABLET, EXTENDED RELEASE;ORAL~ISOSORBIDE MONONITRATE~VINT
AGE PHARMS~30MG~A~090598~001~AB~Aug 11, 2010~No~RX~VINTAGE PHARMACEUTICALS INC

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE~TABLET, EXTENDED RELEASE;ORAL~JAN
UMET XR~MERCK SHARP DOHME~1GM;EQ 50MG BASE~N~202270~002~~Feb 2, 2012~No~RX~MERCK
SHARP AND DOHME CORP
UMET XR~MERCK SHARP DOHME~1GM;EQ 100MG BASE~N~202270~003~~Feb 2, 2012~Yes~RX~MER
CK SHARP AND DOHME CORP
UMET XR~MERCK SHARP DOHME~500MG;EQ 50MG BASE~N~202270~001~~Feb 2, 2012~No~RX~MER
CK SHARP AND DOHME CORP
CLONIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~JENLOGA~CONCORDIA PHARMS I
NC~0.1MG~N~022331~001~~Sep 30, 2009~No~DISCN~CONCORDIA PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~JENLOGA~CONCORDIA PHARMS I
NC~0.2MG~N~022331~002~~May 25, 2010~No~DISCN~CONCORDIA PHARMACEUTICALS INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~K+10~FUTURE PAK~10MEQ~A~070999~
001~~Oct 22, 1987~No~DISCN~FUTURE PAK LTD
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~K+8~FUTURE PAK~8MEQ~A~070998~00
1~~Jan 25, 1993~No~DISCN~FUTURE PAK LTD
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~K-TAB~ABBVIE~8MEQ~N~018279~002~
BC~Aug 1, 1988~No~RX~ABBVIE INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~K-TAB~ABBVIE~10MEQ~N~018279~001
~BC~Approved Prior to Jan 1, 1982~No~RX~ABBVIE INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~K-TAB~ABBVIE~20MEQ~N~018279~003
~BC~Nov 25, 2013~Yes~RX~ABBVIE INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~KAON CL~SAVAGE LABS~6.7MEQ~N~01
7046~001~~Approved Prior to Jan 1, 1982~No~DISCN~SAVAGE LABORATORIES INC DIV ALT
ANA INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~KAON CL-10~SAVAGE LABS~10MEQ~N~
017046~002~~Approved Prior to Jan 1, 1982~No~DISCN~SAVAGE LABORATORIES INC DIV A
LTANA INC
CLONIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~KAPVAY~CONCORDIA PHARMS IN
C~0.1MG~N~022331~003~AB~Sep 28, 2010~Yes~RX~CONCORDIA PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~KAPVAY~CONCORDIA PHARMS IN
C~0.2MG~N~022331~004~AB~Sep 28, 2010~No~RX~CONCORDIA PHARMACEUTICALS INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~KEPPRA XR~UCB INC~500MG~N~022285~001
~AB~Sep 12, 2008~No~RX~UCB INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~KEPPRA XR~UCB INC~750MG~N~022285~002
~AB~Feb 12, 2009~Yes~RX~UCB INC
DESVENLAFAXINE~TABLET, EXTENDED RELEASE;ORAL~KHEDEZLA~OSMOTICA PHARM CORP~50MG~N
~204683~001~BC~Jul 10, 2013~No~RX~OSMOTICA PHARMACEUTICAL CORP
DESVENLAFAXINE~TABLET, EXTENDED RELEASE;ORAL~KHEDEZLA~OSMOTICA PHARM CORP~100MG~
N~204683~002~BC~Jul 10, 2013~No~RX~OSMOTICA PHARMACEUTICAL CORP
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~KLOR-CON~UPSHER-SMITH LABS~8MEQ
~N~019123~001~AB2~Apr 17, 1986~No~RX~UPSHER-SMITH LABORATORIES INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~KLOR-CON~UPSHER-SMITH LABS~10ME
Q~N~019123~002~AB2~Apr 17, 1986~Yes~RX~UPSHER-SMITH LABORATORIES INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~KLOR-CON M10~UPSHER SMITH LABS~
10MEQ~A~074726~002~AB1~Aug 9, 2000~No~RX~UPSHER SMITH LABORATORIES INC
15MEQ~A~074726~003~~Jun 6, 2003~No~RX~UPSHER SMITH LABORATORIES INC
20MEQ~A~074726~001~AB1~Nov 20, 1998~Yes~RX~UPSHER SMITH LABORATORIES INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~KLOTRIX~APOTHECON~10MEQ~N~01785
UIBB
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL
~KOMBIGLYZE XR~ASTRAZENECA AB~1GM;EQ 2.5MG BASE~N~200678~003~~Nov 5, 2010~No~RX~

ASTRAZENECA AB
~KOMBIGLYZE XR~ASTRAZENECA AB~1GM;EQ 5MG BASE~N~200678~002~~Nov 5, 2010~Yes~RX~A
STRAZENECA AB
~KOMBIGLYZE XR~ASTRAZENECA AB~500MG;EQ 5MG BASE~N~200678~001~~Nov 5, 2010~No~RX~
ASTRAZENECA AB
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~LABID~WARNER CHILCOTT~250MG~A~087225~
001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT CO LLC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMICTAL XR~GLAXOSMITHKLINE LLC~25MG~N
~022115~001~AB~May 29, 2009~No~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMICTAL XR~GLAXOSMITHKLINE LLC~50MG~N
~022115~002~AB~May 29, 2009~Yes~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMICTAL XR~GLAXOSMITHKLINE LLC~100MG~
N~022115~003~AB~May 29, 2009~No~RX~GLAXOSMITHKLINE LLC
N~022115~004~AB~May 29, 2009~No~RX~GLAXOSMITHKLINE LLC
N~022115~006~AB~Jun 21, 2011~No~RX~GLAXOSMITHKLINE LLC
N~022115~005~AB~Apr 14, 2010~No~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~ACTAVIS ELIZABETH~100MG~A~
200672~003~AB~Oct 17, 2013~No~RX~ACTAVIS ELIZABETH LLC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~ACTAVIS ELIZABETH~25MG~A~2
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~ACTAVIS ELIZABETH~50MG~A~2
203733~001~AB~Nov 13, 2013~No~RX~ACTAVIS ELIZABETH LLC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~ANCHEN PHARMS~25MG~A~20137
4~001~AB~Dec 26, 2012~No~RX~ANCHEN PHARMACEUTICALS INC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~DR REDDYS LABS LTD~25MG~A~
202383~001~AB~Jun 19, 2013~No~RX~DR REDDYS LABORATORIES LTD
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~DR REDDYS LABS LTD~50MG~A~
202383~002~AB~Jun 19, 2013~No~RX~DR REDDYS LABORATORIES LTD
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~DR REDDYS LABS LTD~100MG~A
~202383~003~AB~Jun 19, 2013~No~RX~DR REDDYS LABORATORIES LTD
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~PAR PHARM~25MG~A~201791~00
1~AB~Jan 18, 2013~No~RX~PAR PHARMACEUTICAL INC

LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~TORRENT PHARMS LTD~25MG~A~
203370~001~AB~Dec 23, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~TORRENT PHARMS LTD~50MG~A~
203370~002~AB~Dec 23, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~TORRENT PHARMS LTD~100MG~A
~203370~003~AB~Dec 23, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~TORRENT PHARMS LTD~200MG~A
~203370~004~AB~Dec 23, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~WILSHIRE PHARMS INC~25MG~A
~202887~001~AB~Jun 17, 2013~No~RX~WILSHIRE PHARMACEUTICALS INC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~WILSHIRE PHARMS INC~50MG~A
~202887~002~AB~Jun 17, 2013~No~RX~WILSHIRE PHARMACEUTICALS INC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~WILSHIRE PHARMS INC~100MG~
A~202887~003~AB~Jun 17, 2013~No~RX~WILSHIRE PHARMACEUTICALS INC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~WILSHIRE PHARMS INC~200MG~
A~202887~004~AB~Jun 17, 2013~No~RX~WILSHIRE PHARMACEUTICALS INC
LAMOTRIGINE~TABLET, EXTENDED RELEASE;ORAL~LAMOTRIGINE~WOCKHARDT LTD~25MG~A~20249
8~001~AB~Jan 4, 2013~No~RX~WOCKHARDT LTD
FLUVASTATIN SODIUM~TABLET, EXTENDED RELEASE;ORAL~LESCOL XL~NOVARTIS~80MG~N~02119
2~001~~Oct 6, 2000~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~ACTAVIS ELIZABETH~500M
G~A~091557~001~AB~Sep 12, 2011~No~RX~ACTAVIS ELIZABETH LLC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~ACTAVIS ELIZABETH~750M
G~A~091557~002~AB~Sep 12, 2011~No~RX~ACTAVIS ELIZABETH LLC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~ACTAVIS LABS FL INC~50
0MG~A~091093~001~AB~Sep 12, 2011~No~RX~ACTAVIS LABORATORIES FL INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~ACTAVIS LABS FL INC~75
0MG~A~091093~002~AB~Sep 12, 2011~No~RX~ACTAVIS LABORATORIES FL INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~ANCHEN PHARMS~500MG~A~
091360~001~AB~Oct 4, 2011~No~RX~ANCHEN PHARMACEUTICALS INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~ANCHEN PHARMS~750MG~A~
091360~002~AB~Oct 4, 2011~No~RX~ANCHEN PHARMACEUTICALS INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~APOTEX INC~1GM~A~20295
8~001~~Feb 25, 2015~No~RX~APOTEX INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~APOTEX INC~500MG~A~091
261~001~AB~Sep 12, 2011~No~RX~APOTEX INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~APOTEX INC~750MG~A~091
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~LUPIN LTD~500MG~A~0913
99~001~AB~Sep 12, 2011~No~RX~LUPIN LIMITED
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~LUPIN LTD~750MG~A~0913
99~002~AB~Sep 12, 2011~No~RX~LUPIN LIMITED
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~MUTUAL PHARM CO INC~50
0MG~A~091285~001~AB~Sep 12, 2011~No~RX~MUTUAL PHARMACEUTICAL CO INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~MUTUAL PHARM CO INC~75

0MG~A~091285~002~AB~Sep 12, 2011~No~RX~MUTUAL PHARMACEUTICAL CO INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~MYLAN PHARMS INC~500MG
~A~200475~001~AB~Dec 19, 2011~No~RX~MYLAN PHARMACEUTICALS INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~MYLAN PHARMS INC~750MG
~A~200475~002~AB~Dec 19, 2011~No~RX~MYLAN PHARMACEUTICALS INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~PAR PHARM~500MG~A~0912
91~001~AB~Sep 12, 2011~No~RX~PAR PHARMACEUTICAL INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~PAR PHARM~750MG~A~0912
91~002~AB~Sep 12, 2011~No~RX~PAR PHARMACEUTICAL INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~ROUSES POINT PHARMS~50
0MG~A~202524~001~AB~Aug 27, 2012~No~RX~ROUSES POINT PHARMACEUTICALS LLC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~ROUSES POINT PHARMS~75
0MG~A~202524~002~AB~Aug 27, 2012~No~RX~ROUSES POINT PHARMACEUTICALS LLC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~SANDOZ~500MG~A~091668~
001~~Nov 1, 2012~No~DISCN~SANDOZ INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~SANDOZ~750MG~A~091668~
002~~Nov 1, 2012~No~DISCN~SANDOZ INC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~SUN PHARMA GLOBAL~500M
G~A~203059~001~AB~Sep 9, 2013~No~RX~SUN PHARMA GLOBAL FZE
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~SUN PHARMA GLOBAL~750M
G~A~203059~002~AB~Sep 9, 2013~No~RX~SUN PHARMA GLOBAL FZE
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~TEVA PHARMS~500MG~A~09
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~TEVA PHARMS~750MG~A~09
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~TORRENT PHARMS LTD~500
MG~A~091338~001~AB~May 29, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~TORRENT PHARMS LTD~750
MG~A~091338~002~AB~May 29, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~VINTAGE PHARMS~500MG~A
~201464~001~AB~May 25, 2012~No~RX~VINTAGE PHARMACEUTICALS
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~VINTAGE PHARMS~750MG~A
~201464~002~AB~May 25, 2012~No~RX~VINTAGE PHARMACEUTICALS
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~VINTAGE PHARMS LLC~500
MG~A~202533~001~AB~Jul 20, 2012~No~RX~VINTAGE PHARMACEUTICALS LLC
LEVETIRACETAM~TABLET, EXTENDED RELEASE;ORAL~LEVETIRACETAM~VINTAGE PHARMS LLC~750
MG~A~202533~002~AB~Jul 20, 2012~No~RX~VINTAGE PHARMACEUTICALS LLC
ENALAPRIL MALEATE; FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~LEXXEL~ASTRAZENECA~5
MG;2.5MG~N~020668~002~~Oct 28, 1998~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
ENALAPRIL MALEATE; FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~LEXXEL~ASTRAZENECA~5
MG;5MG~N~020668~001~~Dec 27, 1996~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~ABLE~300MG~A~0
76382~001~~Apr 21, 2003~No~DISCN~ABLE LABORATORIES INC
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~BARR~300MG~A~0
76170~001~~Jun 10, 2002~No~DISCN~BARR LABORATORIES INC
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~BARR~450MG~A~0
76366~001~~Aug 21, 2003~No~DISCN~BARR LABORATORIES INC
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~GLENMARK GENER
ICS~300MG~A~091544~001~AB~Dec 27, 2010~No~RX~GLENMARK GENERICS LTD INDIA
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~GLENMARK GENER
ICS~450MG~A~091616~001~AB~Feb 14, 2011~No~RX~GLENMARK GENERICS LTD
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~HIKMA INTL PHA
RMS~450MG~A~076490~001~~Jun 17, 2003~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICAL
S LLC
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~MYLAN PHARMS I
NC~300MG~A~202288~001~AB~Jun 29, 2012~No~RX~MYLAN PHARMACEUTICALS INC
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~MYLAN PHARMS I
NC~450MG~A~202219~001~AB~Aug 8, 2012~No~RX~MYLAN PHARMACEUTICALS INC
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~ROXANE~300MG~A
~076832~001~AB~Oct 28, 2004~No~RX~ROXANE LABORATORIES INC

LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHIUM CARBONATE~ROXANE~450MG~A
~076691~001~AB~Jan 5, 2004~Yes~RX~ROXANE LABORATORIES INC
LITHIUM CARBONATE~TABLET, EXTENDED RELEASE;ORAL~LITHOBID~ANI PHARMS INC~300MG~N~
018027~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~ANI PHARMACEUTICALS INC
ETODOLAC~TABLET, EXTENDED RELEASE;ORAL~LODINE XL~WYETH PHARMS INC~400MG~N~020584
~001~~Oct 25, 1996~No~DISCN~WYETH PHARMACEUTICALS INC
~003~~Jan 20, 1998~No~DISCN~WYETH PHARMACEUTICALS INC
~002~~Oct 25, 1996~No~DISCN~WYETH PHARMACEUTICALS INC
METOPROLOL FUMARATE~TABLET, EXTENDED RELEASE;ORAL~LOPRESSOR~NOVARTIS~EQ 100MG TA
RTRATE~N~019786~001~~Dec 27, 1989~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
LORATADINE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~LORATADINE AND
PSEUDOEPHEDRINE SULFATE~ACTAVIS LABS FL INC~5MG;120MG~A~076208~001~~Jan 28, 200
4~No~DISCN~ACTAVIS LABORATORIES FL INC
PSEUDOEPHEDRINE SULFATE~ACTAVIS LABS FL INC~10MG;240MG~A~075706~001~~Feb 21, 20
03~No~OTC~ACTAVIS LABORATORIES FL INC
PSEUDOEPHEDRINE SULFATE~IMPAX LABS~5MG;120MG~A~076050~001~~Jan 30, 2003~No~OTC~
IMPAX LABORATORIES INC
PSEUDOEPHEDRINE SULFATE~IMPAX LABS~10MG;240MG~A~075989~001~~Mar 4, 2004~No~OTC~
IMPAX LABORATORIES INC
PSEUDOEPHEDRINE SULFATE~RANBAXY~10MG;240MG~A~076557~001~~Sep 22, 2004~No~OTC~RA
NBAXY LABORATORIES LTD
ASPIRIN~TABLET, EXTENDED RELEASE;ORAL~MEASURIN~BAYER~650MG~N~016030~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~BAYER HEALTHCARE LLC
PYRIDOSTIGMINE BROMIDE~TABLET, EXTENDED RELEASE;ORAL~MESTINON~VALEANT PHARMS LLC
~180MG~N~011665~001~~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICAL
S NORTH AMERICA LLC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METADATE ER~UCB INC~
10MG~A~040306~001~~Oct 20, 1999~No~DISCN~UCB INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METADATE ER~UCB INC~
20MG~A~089601~001~AB~Jun 1, 1988~Yes~RX~UCB INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~AC
TAVIS ELIZABETH~500MG~A~076450~001~~Oct 1, 2004~No~DISCN~ACTAVIS ELIZABETH LLC
TAVIS ELIZABETH~750MG~A~076878~001~~Apr 13, 2005~No~DISCN~ACTAVIS ELIZABETH LLC
TAVIS LABS FL INC~500MG~A~076172~001~AB1~Jun 16, 2004~No~RX~ACTAVIS LABORATORIES
FL INC
TAVIS LABS FL INC~750MG~A~076869~001~AB~Apr 12, 2005~No~RX~ACTAVIS LABORATORIES
FL INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~AM
NEAL PHARMS NY~500MG~A~078596~001~AB1~Jan 3, 2008~No~RX~AMNEAL PHARMACEUTICALS N
Y LLC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~AM
NEAL PHARMS NY~750MG~A~078596~002~AB~Jan 3, 2008~No~RX~AMNEAL PHARMACEUTICALS NY
LLC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~AP
OTEX~500MG~A~076706~001~AB1~Dec 14, 2004~No~RX~APOTEX INC

METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~AP
OTEX~750MG~A~076706~002~AB~Dec 29, 2005~No~RX~APOTEX INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~AU
ROBINDO PHARMA LTD~500MG~A~079118~001~AB1~Jul 20, 2012~No~RX~AUROBINDO PHARMA LT
D
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~AU
ROBINDO PHARMA LTD~750MG~A~079118~002~AB~Jul 20, 2012~No~RX~AUROBINDO PHARMA LTD
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~BA
RR~500MG~A~076496~001~~Nov 25, 2005~No~DISCN~BARR LABORATORIES INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~BA
RR~750MG~A~076863~001~AB~Oct 14, 2004~No~RX~BARR LABORATORIES INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~CS
PC OUYI PHARM CO~500MG~A~078321~001~AB1~Apr 17, 2008~No~RX~CSPC OUYI PHARMACEUTI
CAL CO LTD
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~CS
PC OUYI PHARM CO~750MG~A~078321~002~AB~Apr 17, 2008~No~RX~CSPC OUYI PHARMACEUTIC
AL CO LTD
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~IM
PAX LABS~500MG~A~076249~001~AB1~Jul 30, 2004~No~RX~IMPAX LABORATORIES INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~IM
PAX LABS~750MG~A~076985~001~AB~Sep 13, 2005~No~RX~IMPAX LABORATORIES INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~IN
VENTIA HLTHCARE~500MG~A~201991~001~AB1~Jan 18, 2012~No~RX~INVENTIA HEALTHCARE PR
IVATE LTD
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~IV
AX SUB TEVA PHARMS~500MG~A~076545~001~~Dec 1, 2003~No~DISCN~IVAX PHARMACEUTICALS
INC SUB TEVA PHARMACEUTICALS USA
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~LU
PIN LTD~1GM~A~090692~002~AB2~Jun 29, 2011~No~RX~LUPIN LTD
PIN LTD~1GM~A~091664~002~AB3~Jul 19, 2013~No~RX~LUPIN LTD
PIN LTD~500MG~A~090692~001~AB2~Jun 29, 2011~No~RX~LUPIN LTD
PIN LTD~500MG~A~091664~001~AB3~Jul 19, 2013~No~RX~LUPIN LTD
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~MU
TUAL PHARM~500MG~A~077124~001~~Dec 21, 2005~No~DISCN~MUTUAL PHARMACEUTICAL CO IN
C
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~MY
LAN~500MG~A~076650~001~AB1~Sep 13, 2005~No~RX~MYLAN PHARMACEUTICALS INC
LAN~750MG~A~077113~001~AB~Sep 8, 2005~No~RX~MYLAN PHARMACEUTICALS INC
LAN PHARMS INC~1GM~A~200690~002~AB2~Aug 1, 2012~No~RX~MYLAN PHARMACEUTICALS INC
LAN PHARMS INC~500MG~A~200690~001~AB2~Aug 1, 2012~No~RX~MYLAN PHARMACEUTICALS IN
C
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~NO
STRUM PHARMS LLC~500MG~A~076756~001~AB1~Jul 26, 2006~No~RX~NOSTRUM PHARMACEUTICA
LS LLC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~NO
STRUM PHARMS LLC~750MG~A~076756~002~AB~Dec 12, 2011~No~RX~NOSTRUM PHARMACEUTICAL
S LLC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~RA
NBAXY LABS LTD~500MG~A~076413~001~~Jun 18, 2004~No~DISCN~RANBAXY LABORATORIES LT
D
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~RA
NBAXY LABS LTD~750MG~A~077211~001~~Jun 29, 2005~No~DISCN~RANBAXY LABORATORIES LT
D
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~SA

NDOZ~500MG~A~076223~001~~Dec 14, 2004~No~DISCN~SANDOZ INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~SA
NDOZ~500MG~A~076873~001~AB1~Dec 14, 2004~No~RX~SANDOZ INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~SU
N PHARM INDS (IN)~500MG~A~077336~001~AB1~Feb 9, 2006~No~RX~SUN PHARMACEUTICAL IN
DUSTRIES LTD
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~SU
N PHARM INDS (IN)~750MG~A~077336~002~AB~Feb 9, 2006~No~RX~SUN PHARMACEUTICAL IND
USTRIES LTD
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~TE
VA~500MG~A~076269~001~AB1~Jun 18, 2004~No~RX~TEVA PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~TE
VA~750MG~A~076864~001~AB~Apr 12, 2005~No~RX~TEVA PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~TO
RRENT PHARM~500MG~A~090014~001~AB1~Dec 30, 2009~No~RX~TORRENT PHARMA INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~TO
RRENT PHARMS LTD~750MG~A~079226~001~~Feb 18, 2010~No~DISCN~TORRENT PHARMACEUTICA
LS LTD
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~WA
TSON LABS INC~500MG~A~076818~001~~Dec 14, 2004~No~DISCN~WATSON LABORATORIES INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~ZY
DUS PHARMS USA~500MG~A~077060~001~AB1~Apr 20, 2005~No~RX~ZYDUS PHARMACEUTICALS U
SA INC
METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METFORMIN HYDROCHLORIDE~ZY
DUS PHARMS USA~750MG~A~077078~001~AB~Apr 21, 2005~No~RX~ZYDUS PHARMACEUTICALS US
A INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METHYLIN ER~MALLINCK
RODT INC~10MG~A~075629~001~~May 9, 2000~No~RX~MALLINCKRODT INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METHYLIN ER~MALLINCK
RODT INC~20MG~A~075629~002~AB~May 9, 2000~No~RX~MALLINCKRODT INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~METHYLPHENIDATE HYDR
OCHLORIDE~ABLE~20MG~A~076032~001~~May 9, 2001~No~DISCN~ABLE LABORATORIES INC
OCHLORIDE~ACTAVIS ELIZABETH~20MG~A~075450~001~~Dec 21, 2001~No~DISCN~ACTAVIS ELI
ZABETH LLC
OCHLORIDE~KUDCO IRELAND~18MG~A~091695~001~BX~Jul 9, 2013~No~RX~KUDCO IRELAND LTD
OCHLORIDE~KUDCO IRELAND~27MG~A~091695~002~BX~Jul 9, 2013~No~RX~KUDCO IRELAND LTD
OCHLORIDE~KUDCO IRELAND~36MG~A~091695~003~BX~Sep 23, 2013~No~RX~KUDCO IRELAND LT
D
OCHLORIDE~KUDCO IRELAND~54MG~A~091695~004~BX~Sep 23, 2013~No~RX~KUDCO IRELAND LT
D
OCHLORIDE~MALLINCKRODT INC~27MG~A~202608~001~BX~Dec 28, 2012~No~RX~MALLINCKRODT
INC
INC
INC
OCHLORIDE~WATSON LABS~20MG~A~040410~001~~Feb 9, 2001~No~DISCN~WATSON LABORATORIE
S INC
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~ACTAVIS
LABS FL INC~EQ 25MG TARTRATE~A~077118~001~AB~Aug 3, 2009~No~RX~ACTAVIS LABORATOR
IES FL INC
LABS FL INC~EQ 50MG TARTRATE~A~076862~001~AB~Aug 3, 2009~No~RX~ACTAVIS LABORATOR
IES FL INC
LABS FL INC~EQ 100MG TARTRATE~A~077298~001~AB~Apr 15, 2010~No~RX~ACTAVIS LABORAT
ORIES FL INC
LABS FL INC~EQ 200MG TARTRATE~A~077298~002~AB~Apr 15, 2010~No~RX~ACTAVIS LABORAT
ORIES FL INC
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~DR REDDY
S LABS LTD~EQ 25MG TARTRATE~A~090617~001~AB~Aug 1, 2012~No~RX~DR REDDYS LABORATO
RIES LTD
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~DR REDDY
S LABS LTD~EQ 50MG TARTRATE~A~090617~002~AB~Aug 1, 2012~No~RX~DR REDDYS LABORATO
RIES LTD
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~MYLAN PH
ARMS INC~EQ 25MG TARTRATE~A~202033~001~AB~Dec 15, 2011~No~RX~MYLAN PHARMACEUTICA
LS INC
ARMS INC~EQ 50MG TARTRATE~A~202033~002~AB~Dec 15, 2011~No~RX~MYLAN PHARMACEUTICA
LS INC
ARMS INC~EQ 100MG TARTRATE~A~202033~003~AB~Dec 15, 2011~No~RX~MYLAN PHARMACEUTIC
ALS INC
ARMS INC~EQ 200MG TARTRATE~A~202033~004~AB~Dec 15, 2011~No~RX~MYLAN PHARMACEUTIC
ALS INC
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~NESHER P
HARMS~EQ 25MG TARTRATE~A~077779~001~~Mar 20, 2008~No~DISCN~NESHER PHARMACEUTICAL
S USA LLC
HARMS~EQ 50MG TARTRATE~A~077176~001~~May 14, 2008~No~DISCN~NESHER PHARMACEUTICAL
S USA LLC
HARMS~EQ 100MG TARTRATE~A~076640~002~~May 18, 2007~No~DISCN~NESHER PHARMACEUTICA
LS USA LLC
HARMS~EQ 200MG TARTRATE~A~076640~001~~May 18, 2007~No~DISCN~NESHER PHARMACEUTICA
LS USA LLC
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~REDDYS~E
Q 100MG TARTRATE~A~078889~001~AB~Aug 15, 2012~No~RX~DOCTOR REDDYS LABORATORIES L
TD
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~REDDYS~E
Q 200MG TARTRATE~A~078889~002~AB~Aug 15, 2012~No~RX~DOCTOR REDDYS LABORATORIES L
TD
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~SANDOZ~E
Q 25MG TARTRATE~A~076969~001~~Jul 31, 2006~No~DISCN~SANDOZ
Q 50MG TARTRATE~A~076969~002~~May 18, 2007~No~DISCN~SANDOZ
Q 100MG TARTRATE~A~076969~003~~Mar 20, 2008~No~DISCN~SANDOZ
Q 200MG TARTRATE~A~076969~004~~Mar 20, 2008~No~DISCN~SANDOZ
METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~METOPROLOL SUCCINATE~WOCKHARD
T~EQ 25MG TARTRATE~A~090615~001~AB~Jul 22, 2010~No~RX~WOCKHARDT LTD

METRONIDAZOLE~TABLET, EXTENDED RELEASE;ORAL~METRONIDAZOLE~ABLE~750MG~A~076462~00
1~~Jun 25, 2003~No~DISCN~ABLE LABORATORIES INC
METRONIDAZOLE~TABLET, EXTENDED RELEASE;ORAL~METRONIDAZOLE~ALEMBIC LTD~750MG~A~09
0222~001~AB~May 5, 2010~No~RX~ALEMBIC LTD
PRAZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~MINIPRESS XL~PFIZER~2.5MG~N
~019775~001~~Jan 29, 1992~No~DISCN~PFIZER INC
PRAZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~MINIPRESS XL~PFIZER~5MG~N~0
19775~002~~Jan 29, 1992~No~DISCN~PFIZER INC
MINOCYCLINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~MINOCYCLINE HYDROCHLORID
E~AUROBINDO PHARMA LTD~EQ 45MG BASE~A~202261~001~AB~Nov 19, 2012~No~RX~AUROBINDO
PHARMA LTD
E~AUROBINDO PHARMA LTD~EQ 90MG BASE~A~202261~003~AB~Nov 19, 2012~No~RX~AUROBINDO
PHARMA LTD
E~AUROBINDO PHARMA LTD~EQ 135MG BASE~A~202261~005~AB~Nov 19, 2012~No~RX~AUROBIND
O PHARMA LTD
E~BARR LABS INC~EQ 45MG BASE~A~065485~001~AB~Mar 17, 2009~No~RX~BARR LABORATORIE
S INC
E~BARR LABS INC~EQ 65MG BASE~A~065485~004~AB~May 18, 2012~No~RX~BARR LABORATORIE
S INC
E~BARR LABS INC~EQ 90MG BASE~A~065485~002~AB~Mar 17, 2009~No~RX~BARR LABORATORIE
S INC
E~BARR LABS INC~EQ 115MG BASE~A~065485~005~AB~May 18, 2012~No~RX~BARR LABORATORI
ES INC
E~BARR LABS INC~EQ 135MG BASE~A~065485~003~AB~Mar 17, 2009~No~RX~BARR LABORATORI
ES INC
E~IMPAX LABS INC~EQ 45MG BASE~A~090024~001~AB~Feb 3, 2009~No~RX~IMPAX LABORATORI
ES INC
E~IMPAX LABS INC~EQ 90MG BASE~A~090024~002~AB~Feb 3, 2009~No~RX~IMPAX LABORATORI
ES INC
E~IMPAX LABS INC~EQ 135MG BASE~A~090024~003~AB~Feb 3, 2009~No~RX~IMPAX LABORATOR
IES INC
E~LUPIN LTD~EQ 45MG BASE~A~091424~001~AB~Nov 30, 2011~No~RX~LUPIN LTD
E~LUPIN LTD~EQ 55MG BASE~A~091424~002~~Nov 30, 2011~No~DISCN~LUPIN LTD
E~MYLAN PHARMS INC~EQ 45MG BASE~A~090911~001~AB~Jul 20, 2010~No~RX~MYLAN PHARMAC
EUTICALS INC
E~MYLAN PHARMS INC~EQ 80MG BASE~A~203443~002~AB~Aug 22, 2014~No~RX~MYLAN PHARMAC
EUTICALS INC
E~MYLAN PHARMS INC~EQ 90MG BASE~A~090911~002~AB~Jul 20, 2010~No~RX~MYLAN PHARMAC
EUTICALS INC

E~MYLAN PHARMS INC~EQ 105MG BASE~A~203443~003~AB~Aug 22, 2014~No~RX~MYLAN PHARMA
CEUTICALS INC
E~MYLAN PHARMS INC~EQ 135MG BASE~A~090911~003~AB~Jul 20, 2010~No~RX~MYLAN PHARMA
CEUTICALS INC
E~RANBAXY LABS LTD~EQ 45MG BASE~A~091118~001~AB~Sep 25, 2014~No~RX~RANBAXY LABOR
ATORIES LTD
ATORIES LTD
ATORIES LTD
E~RANBAXY LABS LTD~EQ 105MG BASE~A~091118~006~AB~Sep 25, 2014~No~RX~RANBAXY LABO
RATORIES LTD
E~RANBAXY LABS LTD~EQ 135MG BASE~A~091118~008~AB~Sep 25, 2014~No~RX~RANBAXY LABO
RATORIES LTD
E~SANDOZ~EQ 45MG BASE~A~090422~001~AB~Aug 13, 2009~No~RX~SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~MIRAPEX ER~BOEHRINGER
INGELHEIM~0.375MG~N~022421~001~AB~Feb 19, 2010~Yes~RX~BOEHRINGER INGELHEIM PHARM
ACEUTICALS INC
INGELHEIM~0.75MG~N~022421~002~AB~Feb 19, 2010~No~RX~BOEHRINGER INGELHEIM PHARMAC
EUTICALS INC
INGELHEIM~1.5MG~N~022421~003~AB~Feb 19, 2010~No~RX~BOEHRINGER INGELHEIM PHARMACE
UTICALS INC
INGELHEIM~2.25MG~N~022421~006~AB~Jun 17, 2011~No~RX~BOEHRINGER INGELHEIM PHARMAC
EUTICALS INC
INGELHEIM~3MG~N~022421~004~AB~Feb 19, 2010~No~RX~BOEHRINGER INGELHEIM PHARMACEUT
ICALS INC
INGELHEIM~3.75MG~N~022421~007~AB~Jun 17, 2011~No~RX~BOEHRINGER INGELHEIM PHARMAC
EUTICALS INC
INGELHEIM~4.5MG~N~022421~005~AB~Feb 19, 2010~No~RX~BOEHRINGER INGELHEIM PHARMACE
UTICALS INC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~DAVA PHARMS INC~
15MG~A~075407~001~AB~Jan 28, 2000~No~RX~DAVA PHARMACEUTICALS INC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~MALLINCKRODT~15M
G~A~076412~001~AB~Jul 31, 2003~No~RX~MALLINCKRODT INC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~MALLINCKRODT~100
MG~A~076438~001~AB~Jul 3, 2003~No~RX~MALLINCKRODT INC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~MALLINCKRODT~200
MG~A~076438~002~AB~Jul 3, 2003~No~RX~MALLINCKRODT INC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~MYLAN PHARMS INC

~15MG~A~200824~001~AB~Oct 18, 2011~No~RX~MYLAN PHARMACEUTICALS INC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~NESHER PHARMS~15
MG~A~076733~001~AB~May 19, 2004~No~RX~NESHER PHARMACEUTICALS USA LLC
MG~A~076720~002~AB~Dec 23, 2005~No~RX~NESHER PHARMACEUTICALS USA LLC
MG~A~076720~001~AB~May 19, 2004~No~RX~NESHER PHARMACEUTICALS USA LLC
0MG~A~077855~001~AB~Sep 27, 2007~No~RX~NESHER PHARMACEUTICALS USA LLC
0MG~A~077855~002~AB~Sep 27, 2007~No~RX~NESHER PHARMACEUTICALS USA LLC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~RANBAXY LABS LTD
~15MG~A~078761~001~AB~May 11, 2012~No~RX~RANBAXY LABORATORIES LTD
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~RHODES PHARMS~15
MG~A~074862~001~AB~Jul 7, 1998~No~RX~RHODES PHARMACEUTICALS LP
0MG~A~074769~001~AB~Jul 2, 1998~No~RX~RHODES PHARMACEUTICALS LP
0MG~A~074769~002~AB~Jul 2, 1998~No~RX~RHODES PHARMACEUTICALS LP
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~VINTAGE PHARMS L
LC~15MG~A~075295~001~AB~Oct 28, 1998~No~RX~VINTAGE PHARMACEUTICALS LLC
LC~100MG~A~075295~004~AB~Sep 15, 2000~No~RX~VINTAGE PHARMACEUTICALS LLC
LC~200MG~A~075295~005~AB~Sep 15, 2000~No~RX~VINTAGE PHARMACEUTICALS LLC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MORPHINE SULFATE~WATSON LABS~100M
G~A~075656~001~~Jan 30, 2001~No~DISCN~WATSON LABORATORIES INC
AMOXICILLIN~TABLET, EXTENDED RELEASE;ORAL~MOXATAG~PRAGMA PHARMS LLC~775MG~N~0508
13~001~~Jan 23, 2008~Yes~RX~PRAGMA PHARMACEUTICALS LLC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MS CONTIN~PURDUE PHARMA LP~15MG~N
~019516~003~AB~Sep 12, 1989~No~RX~PURDUE PHARMA LP
~019516~001~AB~May 29, 1987~No~RX~PURDUE PHARMA LP
~019516~002~AB~Apr 8, 1988~No~RX~PURDUE PHARMA LP
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MS CONTIN~PURDUE PHARMA LP~100MG~

N~019516~004~AB~Jan 16, 1990~Yes~RX~PURDUE PHARMA LP
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~MS CONTIN~PURDUE PHARMA LP~200MG~
N~019516~005~AB~Nov 8, 1993~No~RX~PURDUE PHARMA LP
GUAIFENESIN~TABLET, EXTENDED RELEASE;ORAL~MUCINEX~RECKITT BENCKISER~1.2GM~N~0212
82~002~~Dec 18, 2002~Yes~OTC~RECKITT BENCKISER LLC
GUAIFENESIN~TABLET, EXTENDED RELEASE;ORAL~MUCINEX~RECKITT BENCKISER~600MG~N~0212
82~001~~Jul 12, 2002~No~OTC~RECKITT BENCKISER LLC
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~MUCINEX
D~RECKITT BENCKISER~1.2GM;120MG~N~021585~002~~Jun 22, 2004~Yes~OTC~RECKITT BENC
KISER LLC
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~MUCINEX
D~RECKITT BENCKISER~600MG;60MG~N~021585~001~~Jun 22, 2004~No~OTC~RECKITT BENCKI
SER LLC
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN~TABLET, EXTENDED RELEASE;ORAL~MUCINEX
DM~RECKITT BENCKISER~30MG;600MG~N~021620~002~~Apr 29, 2004~No~OTC~RECKITT BENCK
ISER LLC
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN~TABLET, EXTENDED RELEASE;ORAL~MUCINEX
DM~RECKITT BENCKISER~60MG;1.2GM~N~021620~001~~Apr 29, 2004~Yes~OTC~RECKITT BENC
KISER LLC
MIRABEGRON~TABLET, EXTENDED RELEASE;ORAL~MYRBETRIQ~APGDI~25MG~N~202611~001~~Jun
28, 2012~No~RX~ASTELLAS PHARMA GLOBAL DEVELOPMENT INC
MIRABEGRON~TABLET, EXTENDED RELEASE;ORAL~MYRBETRIQ~APGDI~50MG~N~202611~002~~Jun
28, 2012~Yes~RX~ASTELLAS PHARMA GLOBAL DEVELOPMENT INC
NAPROXEN SODIUM~TABLET, EXTENDED RELEASE;ORAL~NAPRELAN~ALMATICA PHARMA INC~EQ 37
5MG BASE~N~020353~001~AB~Jan 5, 1996~No~RX~ALMATICA PHARMA INC
0MG BASE~N~020353~002~AB~Jan 5, 1996~No~RX~ALMATICA PHARMA INC
0MG BASE~N~020353~003~~Jan 5, 1996~Yes~RX~ALMATICA PHARMA INC
NAPROXEN SODIUM~TABLET, EXTENDED RELEASE;ORAL~NAPROXEN SODIUM~ACTAVIS LABS FL IN
C~EQ 375MG BASE~A~075416~002~AB~Apr 23, 2003~No~RX~ACTAVIS LABORATORIES FL INC
NAPROXEN SODIUM~TABLET, EXTENDED RELEASE;ORAL~NAPROXEN SODIUM~ACTAVIS LABS FL IN
C~EQ 500MG BASE~A~075416~001~AB~Aug 27, 2002~No~RX~ACTAVIS LABORATORIES FL INC
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~NAP
ROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE~DR REDDYS LABS INC~EQ 220MG BASE;
120MG~A~077381~001~~Sep 27, 2006~No~OTC~DR REDDYS LABORATORIES INC
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~NAP
ROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE~PERRIGO~EQ 200MG BASE;120MG~A~076
518~001~~Mar 17, 2004~No~OTC~L PERRIGO CO
NEVIRAPINE~TABLET, EXTENDED RELEASE;ORAL~NEVIRAPINE~APOTEX INC~400MG~A~205258~00
1~AB~Apr 3, 2014~No~RX~APOTEX INC
NEVIRAPINE~TABLET, EXTENDED RELEASE;ORAL~NEVIRAPINE~MYLAN PHARMS INC~400MG~A~205
NEVIRAPINE~TABLET, EXTENDED RELEASE;ORAL~NEVIRAPINE~SANDOZ~400MG~A~203411~001~AB
~Apr 3, 2014~No~RX~SANDOZ INC
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~BARR~1GM~A~076250~001~AB~Apr 14, 200
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~BARR~500MG~A~076378~001~AB~Apr 26, 2
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~BARR~750MG~A~076378~002~AB~Apr 26, 2
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~LUPIN LTD~1GM~A~090446~001~AB~Mar 20
, 2014~No~RX~LUPIN LTD
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~LUPIN LTD~500MG~A~090860~001~AB~Mar
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~LUPIN LTD~750MG~A~090892~001~AB~Mar
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~SUN PHARMA GLOBAL~1GM~A~200484~002~A
B~Apr 23, 2014~No~RX~SUN PHARMA GLOBAL FZE
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~SUN PHARMA GLOBAL~500MG~A~200484~001

~AB~Apr 23, 2014~No~RX~SUN PHARMA GLOBAL FZE
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIACIN~SUN PHARMA GLOBAL~750MG~A~201273~001
~AB~Apr 23, 2014~No~RX~SUN PHARMA GLOBAL FZE
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIASPAN~ABBVIE~1GM~N~020381~004~AB~Jul 28,
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIASPAN~ABBVIE~375MG~N~020381~001~~Jul 28,
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIASPAN~ABBVIE~500MG~N~020381~002~AB~Jul 28
, 1997~No~RX~ABBVIE INC
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIASPAN~ABBVIE~750MG~N~020381~003~AB~Jul 28
, 1997~Yes~RX~ABBVIE INC
NIACIN~TABLET, EXTENDED RELEASE;ORAL~NIASPAN TITRATION STARTER PACK~ABBVIE~375MG
;500MG;750MG~N~020381~005~~Jul 28, 1997~No~DISCN~ABBVIE INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~NIFEDIPINE~MARTEC USA LLC~90MG~A~075414
~003~~Mar 23, 2004~No~DISCN~MARTEC USA LLC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~NIFEDIPINE~MATRIX LABS LTD~30MG~A~09060
2~001~AB2~Sep 13, 2010~No~RX~MATRIX LABORATORIES LTD
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~NIFEDIPINE~MYLAN~30MG~A~075108~001~~Dec
17, 1999~No~DISCN~MYLAN PHARMACEUTICALS INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~NIFEDIPINE~MYLAN~30MG~A~090649~001~AB2~
Jun 21, 2010~No~RX~MYLAN PHARMACEUTICALS INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~NIFEDIPINE~OSMOTICA PHARM~30MG~A~077127
~001~AB2~Nov 21, 2005~No~RX~OSMOTICA PHARMACEUTICAL CORP
~002~AB2~Nov 21, 2005~No~RX~OSMOTICA PHARMACEUTICAL CORP
~001~AB2~Oct 3, 2007~No~RX~OSMOTICA PHARMACEUTICAL CORP
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~NIFEDIPINE~PAR PHARM~30MG~A~077899~001~
AB1~Dec 13, 2006~No~RX~PAR PHARMACEUTICAL INC
AB1~Dec 13, 2006~No~RX~PAR PHARMACEUTICAL INC
AB1~May 25, 2012~No~RX~PAR PHARMACEUTICAL INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~NIFEDIPINE~TWI PHARMS INC~30MG~A~203126
~001~AB2~Apr 3, 2014~No~RX~TWI PHARMACEUTICALS INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~NIFEDIPINE~VALEANT INTL~30MG~A~075269~0
01~AB1~Dec 4, 2000~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
02~AB2~Feb 6, 2001~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
02~AB1~Dec 4, 2000~No~RX~VALEANT INTERNATIONAL BARBADOS SRL

01~AB2~Sep 27, 2000~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
01~AB1~Aug 16, 2002~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~NISOLDIPINE~MYLAN~8.5MG~A~091001~001~A
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~NISOLDIPINE~MYLAN~17MG~A~091001~002~AB
~Jan 26, 2011~No~RX~MYLAN PHARMACEUTICALS INC
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~NISOLDIPINE~MYLAN~20MG~A~079051~001~~J
ul 25, 2008~No~RX~MYLAN PHARMACEUTICALS INC
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~NISOLDIPINE~MYLAN~25.5MG~A~091001~003~
ul 25, 2008~Yes~RX~MYLAN PHARMACEUTICALS INC
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~NISOLDIPINE~MYLAN~34MG~A~091001~004~AB
ul 25, 2008~Yes~RX~MYLAN PHARMACEUTICALS INC
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~NORFLEX~MEDICIS~100MG~N~01215
7~001~~Approved Prior to Jan 1, 1982~No~DISCN~MEDICIS PHARMACEUTICAL CORP
TAPENTADOL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~NUCYNTA ER~JANSSEN PHARMS
~EQ 50MG BASE~N~200533~001~~Aug 25, 2011~No~RX~JANSSEN PHARMACEUTICALS INC
~EQ 250MG BASE~N~200533~005~~Aug 25, 2011~Yes~RX~JANSSEN PHARMACEUTICALS INC
TRAZODONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OLEPTRO~ANGELINI PHARMA~15
0MG~N~022411~001~~Feb 2, 2010~Yes~RX~ANGELINI PHARMA INC
TRAZODONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OLEPTRO~ANGELINI PHARMA~30
0MG~N~022411~002~~Feb 2, 2010~No~RX~ANGELINI PHARMA INC
OXYMORPHONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OPANA ER~ENDO PHARMS~5MG
~N~021610~001~~Jun 22, 2006~No~DISCN~ENDO PHARMACEUTICALS INC
OXYMORPHONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OPANA ER~ENDO PHARMS~5MG
~N~201655~001~~Dec 9, 2011~No~RX~ENDO PHARMACEUTICALS INC
OXYMORPHONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OPANA ER~ENDO PHARMS~7.5
MG~N~021610~005~~Feb 29, 2008~No~DISCN~ENDO PHARMACEUTICALS INC
OXYMORPHONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OPANA ER~ENDO PHARMS~7.5
MG~N~201655~002~~Dec 9, 2011~No~RX~ENDO PHARMACEUTICALS INC
OXYMORPHONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OPANA ER~ENDO PHARMS~10M
G~N~021610~002~~Jun 22, 2006~No~DISCN~ENDO PHARMACEUTICALS INC
G~N~201655~003~~Dec 9, 2011~No~RX~ENDO PHARMACEUTICALS INC
G~N~021610~006~~Feb 29, 2008~No~DISCN~ENDO PHARMACEUTICALS INC
G~N~021610~007~~Feb 29, 2008~No~DISCN~ENDO PHARMACEUTICALS INC

G~N~201655~007~~Dec 9, 2011~Yes~RX~ENDO PHARMACEUTICALS INC
MORPHINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~ORAMORPH SR~XANODYNE PHARMS INC~1
5MG~N~019977~004~~Nov 23, 1994~No~DISCN~XANODYNE PHARMACEUTICALS INC
0MG~N~019977~001~~Aug 15, 1991~No~DISCN~XANODYNE PHARMACEUTICALS INC
TREPROSTINIL DIOLAMINE~TABLET, EXTENDED RELEASE;ORAL~ORENITRAM~UNITED THERAP~EQ
0.125MG BASE~N~203496~001~~Dec 20, 2013~No~RX~UNITED THERAPEUTICS CORP
0.25MG BASE~N~203496~002~~Dec 20, 2013~No~RX~UNITED THERAPEUTICS CORP
1MG BASE~N~203496~003~~Dec 20, 2013~No~RX~UNITED THERAPEUTICS CORP
2.5MG BASE~N~203496~004~~Dec 20, 2013~Yes~RX~UNITED THERAPEUTICS CORP
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~ORPHENADRINE CITRATE~ASCOT~10
0MG~A~088067~001~~Apr 6, 1983~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVEN
OL LABORATORIES INC
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~ORPHENADRINE CITRATE~GAVIS PH
ARMS~100MG~A~040284~001~AB~Jun 19, 1998~No~RX~GAVIS PHARMACEUTICALS LLC
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~ORPHENADRINE CITRATE~IMPAX PH
ARMS~100MG~A~040368~001~AB~Jun 23, 2000~No~RX~IMPAX PHARMACEUTICALS
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~ORPHENADRINE CITRATE~INVAGEN
PHARMS~100MG~A~091158~001~AB~Jul 27, 2012~No~RX~INVAGEN PHARMACEUTICALS INC
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~ORPHENADRINE CITRATE~SANDOZ~1
00MG~A~040327~001~AB~Feb 15, 2000~Yes~RX~SANDOZ INC
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~ORPHENADRINE CITRATE~SANDOZ~1
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~ORPHENADRINE CITRATE~TEDOR PH
ARMA INC~100MG~A~040249~001~AB~Jan 29, 1999~No~RX~TEDOR PHARMA INC
ORPHENADRINE CITRATE~TABLET, EXTENDED RELEASE;ORAL~ORPHENADRINE CITRATE~WATSON L
ABS~100MG~A~084303~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORI
ES INC
OXCARBAZEPINE~TABLET, EXTENDED RELEASE;ORAL~OXTELLAR XR~SUPERNUS PHARMS~150MG~N~
202810~001~~Oct 19, 2012~No~RX~SUPERNUS PHARMACEUTICALS INC
202810~002~~Oct 19, 2012~No~RX~SUPERNUS PHARMACEUTICALS INC
202810~003~~Oct 19, 2012~Yes~RX~SUPERNUS PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OXYBUTYNIN CHLORIDE~IMPAX PHAR
MS~5MG~A~076745~002~AB~May 9, 2007~No~RX~IMPAX PHARMACEUTICALS
MS~10MG~A~076745~003~AB~May 9, 2007~No~RX~IMPAX PHARMACEUTICALS
MS~15MG~A~076745~001~AB~Nov 9, 2006~No~RX~IMPAX PHARMACEUTICALS
OXYBUTYNIN CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OXYBUTYNIN CHLORIDE~MYLAN~5MG~
A~076702~001~AB~Nov 9, 2006~No~RX~MYLAN PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OXYBUTYNIN CHLORIDE~MYLAN PHAR
MS INC~10MG~A~076644~001~AB~Nov 9, 2006~No~RX~MYLAN PHARMACEUTICALS INC.
OXYBUTYNIN CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OXYBUTYNIN CHLORIDE~MYLAN PHAR
MS INC~15MG~A~076644~002~AB~May 10, 2007~No~RX~MYLAN PHARMACEUTICALS INC.
OXYBUTYNIN CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OXYBUTYNIN CHLORIDE~OSMOTICA P
HARM~5MG~A~078503~001~AB~Feb 4, 2009~No~RX~OSMOTICA PHARMACEUTICAL CORP
OXYCODONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OXYCONTIN~PURDUE PHARMA LP

~10MG~N~022272~001~~Apr 5, 2010~No~RX~PURDUE PHARMA LP
~40MG~N~022272~005~~Apr 5, 2010~Yes~RX~PURDUE PHARMA LP
OXYMORPHONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~OXYMORPHONE HYDROCHLORID
E~ACTAVIS ELIZABETH~5MG~A~079046~003~AB~Jul 11, 2013~No~RX~ACTAVIS ELIZABETH LLC
E~ACTAVIS ELIZABETH~7.5MG~A~079046~001~AB~Dec 13, 2010~No~RX~ACTAVIS ELIZABETH L
LC
E~ACTAVIS ELIZABETH~10MG~A~079046~004~AB~Jul 11, 2013~No~RX~ACTAVIS ELIZABETH LL
C
E~ACTAVIS ELIZABETH~15MG~A~079046~002~AB~Dec 13, 2010~No~RX~ACTAVIS ELIZABETH LL
C
C
C
C
E~IMPAX LABS~5MG~A~079087~001~AB~Jun 14, 2010~No~RX~IMPAX LABORATORIES INC
E~IMPAX LABS~7.5MG~A~079087~002~AB~Dec 21, 2010~No~RX~IMPAX LABORATORIES INC
E~IMPAX LABS~15MG~A~079087~004~AB~Dec 21, 2010~No~RX~IMPAX LABORATORIES INC
E~IMPAX LABS~30MG~A~079087~006~AB~Jul 22, 2010~No~RX~IMPAX LABORATORIES INC
E~MALLINCKRODT INC~5MG~A~202946~001~AB~Jun 27, 2014~No~RX~MALLINCKRODT INC
E~MALLINCKRODT INC~7.5MG~A~202946~002~AB~Jun 27, 2014~No~RX~MALLINCKRODT INC

E~PAR PHARM~5MG~A~200792~001~AB~Oct 24, 2014~No~RX~PAR PHARMACEUTICAL INC
E~PAR PHARM~7.5MG~A~200792~002~AB~Oct 24, 2014~No~RX~PAR PHARMACEUTICAL INC
E~ROXANE~5MG~A~200822~002~AB~Jul 15, 2013~No~RX~ROXANE LABORATORIES INC
E~ROXANE~7.5MG~A~200822~003~AB~Jul 15, 2013~No~RX~ROXANE LABORATORIES INC
PAROXETINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PAROXETINE HYDROCHLORIDE~
MYLAN~EQ 12.5MG BASE~A~077873~001~AB~Jun 29, 2007~No~RX~MYLAN PHARMACEUTICALS IN
C
MYLAN~EQ 25MG BASE~A~077873~002~AB~Jun 29, 2007~No~RX~MYLAN PHARMACEUTICALS INC
MYLAN~EQ 37.5MG BASE~A~091427~001~AB~Apr 14, 2011~No~RX~MYLAN PHARMACEUTICALS IN
C
PAROXETINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PAXIL CR~APOTEX TECHNOLOG
IES~EQ 12.5MG BASE~N~020936~001~AB~Feb 16, 1999~No~RX~APOTEX TECHNOLOGIES INC
IES~EQ 25MG BASE~N~020936~002~AB~Feb 16, 1999~No~RX~APOTEX TECHNOLOGIES INC
IES~EQ 37.5MG BASE~N~020936~003~AB~Dec 6, 2000~Yes~RX~APOTEX TECHNOLOGIES INC
TRIPELENNAMINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PBZ-SR~NOVARTIS~50MG~
N~010533~002~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CO
RP
TRIPELENNAMINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PBZ-SR~NOVARTIS~100MG
~N~010533~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS C
ORP
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~ACTAVIS ELIZABETH~40
0MG~A~074878~001~~Jul 9, 1997~No~DISCN~ACTAVIS ELIZABETH LLC
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~APOTEX~400MG~A~07519
1~001~AB~Jun 9, 1999~No~RX~APOTEX INC
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~HERITAGE PHARMS INC~
400MG~A~074877~001~~Jul 8, 1997~No~DISCN~HERITAGE PHARMACEUTICALS INC
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~IMPAX LABS~400MG~A~0
75093~001~AB~Aug 10, 1999~No~RX~IMPAX LABORATORIES INC
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~MYLAN~400MG~A~074425
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~PLIVA~400MG~A~074874

~001~AB~May 25, 1999~No~RX~PLIVA INC
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~TEVA~400MG~A~075199~
001~~Sep 3, 1999~No~DISCN~TEVA PHARMACEUTICALS USA INC
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~VALEANT PHARMS~400MG
~A~075028~001~AB~Jul 20, 1998~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIFYLLINE~WATSON LABS~400MG~A~
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~PENTOXIL~UPSHER SMITH~400MG~A~07496
2~001~AB~Mar 31, 1999~No~RX~UPSHER SMITH LABORATORIES INC
FLUPHENAZINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PERMITIL~SCHERING~1MG~N
~012419~004~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING P
LOUGH CORP
AMINOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~PHYLLOCONTIN~PHARM RES ASSOC~225MG~A
~086760~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSO
C INC
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~PLENDIL~ASTRAZENECA~2.5MG~N~019834~004~
AB~Sep 22, 1994~No~RX~ASTRAZENECA PHARMACEUTICALS LP
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~PLENDIL~ASTRAZENECA~5MG~N~019834~001~AB
~Jul 25, 1991~No~RX~ASTRAZENECA PHARMACEUTICALS LP
FELODIPINE~TABLET, EXTENDED RELEASE;ORAL~PLENDIL~ASTRAZENECA~10MG~N~019834~002~A
B~Jul 25, 1991~No~RX~ASTRAZENECA PHARMACEUTICALS LP
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~ACTAVIS LABS
FL INC~10MEQ~A~075604~001~AB1~Apr 10, 2002~No~RX~ACTAVIS LABORATORIES FL INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~ACTAVIS LABS
FL INC~20MEQ~A~075604~002~AB1~Apr 10, 2002~No~RX~ACTAVIS LABORATORIES FL INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~COPLEY PHARM
~8MEQ~A~070618~001~~Sep 9, 1987~No~DISCN~COPLEY PHARMACEUTICAL INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~EURAND~20MEQ
~A~076368~001~AB1~Aug 18, 2004~No~RX~EURAND AMERICA INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~MYLAN PHARMS
INC~8MEQ~A~204662~001~AB2~Aug 21, 2014~No~RX~MYLAN PHARMACEUTICALS INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~MYLAN PHARMS
INC~10MEQ~A~204662~002~AB2~Aug 21, 2014~No~RX~MYLAN PHARMACEUTICALS INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~NESHER PHARM
S~20MEQ~A~076044~001~~Apr 5, 2002~No~DISCN~NESHER PHARMACEUTICALS USA LLC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~SCHERING~10M
EQ~N~019439~002~~Jun 13, 1986~No~DISCN~MERCK INC
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CHLORIDE~SCHERING~20M
EQ~N~019439~001~~Jun 13, 1986~No~DISCN~MERCK INC
POTASSIUM CITRATE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CITRATE~COREPHARMA~5ME
Q~A~077440~001~AB~Jun 9, 2006~No~RX~COREPHARMA LLC
POTASSIUM CITRATE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CITRATE~COREPHARMA~10M
EQ~A~077440~002~AB~Jun 9, 2006~No~RX~COREPHARMA LLC
POTASSIUM CITRATE~TABLET, EXTENDED RELEASE;ORAL~POTASSIUM CITRATE~ZYDUS PHARMS U
SA INC~5MEQ~A~203546~001~AB~Aug 6, 2014~No~RX~ZYDUS PHARMACEUTICALS USA INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PRAMIPEXOLE DIHYDROCHL
ORIDE~ANCHEN PHARMS~0.375MG~A~202206~001~AB~Feb 6, 2014~No~RX~ANCHEN PHARMACEUTI
CALS INC
ORIDE~ANCHEN PHARMS~0.75MG~A~202206~002~AB~Feb 6, 2014~No~RX~ANCHEN PHARMACEUTIC
ALS INC
ORIDE~ANCHEN PHARMS~1.5MG~A~202206~003~AB~Feb 6, 2014~No~RX~ANCHEN PHARMACEUTICA
LS INC

ALS INC
ORIDE~ANCHEN PHARMS~3MG~A~202206~005~AB~Feb 6, 2014~No~RX~ANCHEN PHARMACEUTICALS
INC
ALS INC
ORIDE~ANCHEN PHARMS~4.5MG~A~202206~007~AB~Feb 6, 2014~No~RX~ANCHEN PHARMACEUTICA
LS INC
PHENMETRAZINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PRELUDIN~BOEHRINGER IN
GELHEIM~50MG~N~011752~004~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER ING
PHENMETRAZINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PRELUDIN~BOEHRINGER IN
GELHEIM~75MG~N~011752~003~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER ING
DESVENLAFAXINE SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~PRISTIQ~WYETH PHARMS INC~
EQ 25MG BASE~N~021992~003~~Aug 20, 2014~No~RX~WYETH PHARMACEUTICALS INC
EQ 50MG BASE~N~021992~001~~Feb 29, 2008~Yes~RX~WYETH PHARMACEUTICALS INC
EQ 100MG BASE~N~021992~002~~Feb 29, 2008~Yes~RX~WYETH PHARMACEUTICALS INC
PROCAINAMIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PROCAINAMIDE HYDROCHLOR
IDE~ANI PHARMS INC~1GM~A~040111~001~~Dec 13, 1996~No~DISCN~ANI PHARMACEUTICALS I
NC
IDE~ANI PHARMS INC~250MG~A~088958~001~~Dec 2, 1985~No~DISCN~ANI PHARMACEUTICALS
INC
IDE~ANI PHARMS INC~500MG~A~088959~001~~Dec 2, 1985~No~DISCN~ANI PHARMACEUTICALS
INC
IDE~ANI PHARMS INC~500MG~A~088974~001~~Jul 22, 1985~No~DISCN~ANI PHARMACEUTICALS
INC
IDE~ANI PHARMS INC~750MG~A~089438~001~~Mar 23, 1987~No~DISCN~ANI PHARMACEUTICALS
INC
IDE~INWOOD LABS~500MG~A~089840~001~~Mar 6, 1989~No~DISCN~INWOOD LABORATORIES INC
IDE~SANDOZ~250MG~A~089369~001~~Aug 14, 1987~No~DISCN~SANDOZ INC
IDE~SANDOZ~500MG~A~089284~001~~Jun 23, 1986~No~DISCN~SANDOZ INC
IDE~SANDOZ~500MG~A~089370~001~~Jan 9, 1987~No~DISCN~SANDOZ INC
IDE~SANDOZ~750MG~A~089371~001~~Aug 14, 1987~No~DISCN~SANDOZ INC
IDE~WATSON LABS~1GM~A~089520~001~~Jan 15, 1987~No~DISCN~WATSON LABORATORIES INC
IDE~WATSON LABS~250MG~A~088533~001~~Dec 3, 1984~No~DISCN~WATSON LABORATORIES INC
IDE~WATSON LABS~250MG~A~089026~001~~Oct 22, 1985~No~DISCN~WATSON LABORATORIES IN
C
IDE~WATSON LABS~500MG~A~088534~001~~Dec 3, 1984~No~DISCN~WATSON LABORATORIES INC
C
IDE~WATSON LABS~750MG~A~088535~001~~Nov 3, 1984~No~DISCN~WATSON LABORATORIES INC
C
PROCAINAMIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PROCAN SR~PARKE DAVIS~2
50MG~A~086468~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER
LAMBERT CO
PROCAINAMIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PROCAN SR~PARKEDALE~1GM
~A~088489~001~~Jan 16, 1985~No~DISCN~PARKEDALE PHARMACEUTICALS INC
PROCAINAMIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PROCAN SR~PARKEDALE~500
MG~A~086065~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICAL
S INC
PROCAINAMIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PROCAN SR~PARKEDALE~750
MG~A~087510~001~~Apr 1, 1982~No~DISCN~PARKEDALE PHARMACEUTICALS INC
PROCAINAMIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PROCANBID~KING PHARMS~1
GM~N~020545~002~~Jan 31, 1996~No~DISCN~KING PHARMACEUTICALS INC
PROCAINAMIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PROCANBID~KING PHARMS~5
00MG~N~020545~001~~Jan 31, 1996~No~DISCN~KING PHARMACEUTICALS INC
NIFEDIPINE~TABLET, EXTENDED RELEASE;ORAL~PROCARDIA XL~PFIZER~30MG~N~019684~001~A
B2~Sep 6, 1989~No~RX~PFIZER LABORATORIES DIV PFIZER INC
B2~Sep 6, 1989~No~RX~PFIZER LABORATORIES DIV PFIZER INC
B2~Sep 6, 1989~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC
PROCAINAMIDE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PRONESTYL-SR~APOTHECON~
500MG~A~087361~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRI
STOL MYERS SQUIBB
CIPROFLOXACIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PROQUIN XR~DEPOMED INC
~EQ 500MG BASE~N~021744~001~~May 19, 2005~No~DISCN~DEPOMED INC
ALBUTEROL SULFATE~TABLET, EXTENDED RELEASE;ORAL~PROVENTIL~SCHERING~EQ 4MG BASE~N
~019383~001~~Jul 13, 1987~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PSEUDOEPHEDRINE HYDR
OCHLORIDE~PERRIGO~120MG~A~075153~001~~Feb 26, 1999~No~OTC~PERRIGO CO
PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~PSEUDOEPHEDRINE HYDR
OCHLORIDE~RANBAXY~120MG~A~077442~001~~Sep 28, 2005~No~OTC~RANBAXY LABORATORIES L
TD
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~QUIBRON-T/SR~MONARCH PHARMS~300MG~A~0
87563~001~~Jun 21, 1983~No~DISCN~MONARCH PHARMACEUTICALS INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINAGLUTE~BAYER HLTHCARE~324M
G~N~016647~001~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER HEALTHCARE PHARMACE
UTICALS INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINALAN~LANNETT~324MG~A~08808
1~001~~Feb 10, 1986~No~DISCN~LANNETT CO INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINATIME~WATSON LABS~324MG~A~
QUINIDINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDEX~WYETH PHARMS INC~300MG~
N~012796~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICALS INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE GLUCONATE~ASCOT~324M
G~A~088582~001~~Jun 17, 1985~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENO
L LABORATORIES INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE GLUCONATE~HALSEY~324
MG~A~089476~001~~Apr 10, 1987~No~DISCN~HALSEY DRUG CO INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE GLUCONATE~MUTUAL PHA
RM~324MG~A~089338~001~BX~Feb 11, 1987~Yes~RX~MUTUAL PHARMACEUTICAL CO INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE GLUCONATE~ROXANE~324
MG~A~088431~001~~Jan 6, 1984~No~DISCN~ROXANE LABORATORIES INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE GLUCONATE~SANDOZ~324
MG~A~089894~001~~Dec 15, 1988~No~DISCN~SANDOZ INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE GLUCONATE~SUPERPHARM

~324MG~A~089164~001~~Nov 21, 1985~No~DISCN~SUPERPHARM CORP
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE GLUCONATE~WATSON LAB
S~324MG~A~087785~001~~Jan 24, 1983~No~DISCN~WATSON LABORATORIES INC
QUINIDINE GLUCONATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE GLUCONATE~WATSON LAB
S~324MG~A~087810~001~~Sep 29, 1982~No~DISCN~WATSON LABORATORIES INC
QUINIDINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~QUINIDINE SULFATE~TEVA PHARMS~30
0MG~A~040045~001~~Jun 30, 1994~Yes~RX~TEVA PHARMACEUTICALS USA
RANOLAZINE~TABLET, EXTENDED RELEASE;ORAL~RANEXA~GILEAD~1GM~N~021526~001~AB~Feb 1
2, 2007~Yes~RX~GILEAD SCIENCES INC
RANOLAZINE~TABLET, EXTENDED RELEASE;ORAL~RANEXA~GILEAD~500MG~N~021526~002~AB~Jan
27, 2006~No~RX~GILEAD SCIENCES INC
RANOLAZINE~TABLET, EXTENDED RELEASE;ORAL~RANOLAZINE~LUPIN LTD~500MG~A~201046~001
~AB~Jul 29, 2013~No~RX~LUPIN LTD
RANOLAZINE~TABLET, EXTENDED RELEASE;ORAL~RANOLAZINE~LUPIN LTD~1GM~A~201046~002~A
B~Jul 29, 2013~No~RX~LUPIN LTD
ROPINIROLE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~REQUIP XL~GLAXOSMITHKLINE
LLC~EQ 2MG BASE~N~022008~001~AB~Jun 13, 2008~Yes~RX~GLAXOSMITHKLINE LLC
LLC~EQ 3MG BASE~N~022008~002~~Jun 13, 2008~No~DISCN~GLAXOSMITHKLINE LLC
LLC~EQ 4MG BASE~N~022008~003~AB~Jun 13, 2008~No~RX~GLAXOSMITHKLINE LLC
LLC~EQ 6MG BASE~N~022008~006~AB~Apr 10, 2009~No~RX~GLAXOSMITHKLINE LLC
LLC~EQ 8MG BASE~N~022008~004~AB~Jun 13, 2008~No~RX~GLAXOSMITHKLINE LLC
LLC~EQ 12MG BASE~N~022008~005~AB~Oct 31, 2008~No~RX~GLAXOSMITHKLINE LLC
L~RESPORAL~PIONEER PHARMS~6MG;120MG~A~089139~001~~Jun 16, 1988~No~DISCN~PIONEER
PHARMACEUTICALS INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~RITALIN-SR~NOVARTIS~
20MG~N~018029~001~AB~Mar 30, 1982~No~RX~NOVARTIS PHARMACEUTICALS CORP
ROPINIROLE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ROPINIROLE HYDROCHLORIDE~
ACTAVIS ELIZABETH~EQ 2MG BASE~A~090869~001~AB~May 17, 2012~No~RX~ACTAVIS ELIZABE
TH LLC
TH LLC
TH LLC
TH LLC
ACTAVIS ELIZABETH~EQ 12MG BASE~A~090869~005~AB~May 17, 2012~No~RX~ACTAVIS ELIZAB
ETH LLC
ALEMBIC LTD~EQ 2MG BASE~A~202786~001~AB~Apr 22, 2013~No~RX~ALEMBIC LTD
DR REDDYS LABS LTD~EQ 2MG BASE~A~201576~001~AB~Jun 6, 2012~No~RX~DR REDDYS LABOR
ATORIES LTD
ATORIES LTD
ATORIES LTD
ATORIES LTD
DR REDDYS LABS LTD~EQ 12MG BASE~A~201576~005~AB~Jun 6, 2012~No~RX~DR REDDYS LABO
RATORIES LTD
MYLAN PHARMS INC~EQ 2MG BASE~A~200462~001~AB~Oct 15, 2012~No~RX~MYLAN PHARMACEUT
ICALS INC
MYLAN PHARMS INC~EQ 3MG BASE~A~200462~002~~Oct 15, 2012~No~RX~MYLAN PHARMACEUTIC
ALS INC
ICALS INC
ICALS INC
ICALS INC
MYLAN PHARMS INC~EQ 12MG BASE~A~200462~006~AB~Oct 15, 2012~No~RX~MYLAN PHARMACEU
TICALS INC
SANDOZ INC~EQ 2MG BASE~A~201047~001~AB~Jun 6, 2012~No~RX~SANDOZ INC
WATSON LABS INC~EQ 2MG BASE~A~200431~001~AB~Jun 6, 2012~No~RX~WATSON LABORATORIE
S INC
S INC
S INC
S INC
WATSON LABS INC~EQ 12MG BASE~A~200431~005~AB~Jun 6, 2012~No~RX~WATSON LABORATORI
ES INC
WOCKHARDT LTD~EQ 2MG BASE~A~091395~001~AB~Aug 27, 2012~No~RX~WOCKHARDT LTD

OXYCODONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ROXICODONE~ROXANE~10MG~N~0
20932~001~~Oct 26, 1998~No~DISCN~ROXANE LABORATORIES INC
OXYCODONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ROXICODONE~ROXANE~30MG~N~0
20932~002~~Oct 26, 1998~No~DISCN~ROXANE LABORATORIES INC
TRAMADOL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~RYZOLT~PURDUE PHARMA~100MG~
N~021745~001~~Dec 30, 2008~No~DISCN~PURDUE PHARMA PRODUCTS LP
QUETIAPINE FUMARATE~TABLET, EXTENDED RELEASE;ORAL~SEROQUEL XR~ASTRAZENECA~EQ 50M
G BASE~N~022047~001~~May 17, 2007~No~RX~ASTRAZENECA PHARMACEUTICALS LP
QUETIAPINE FUMARATE~TABLET, EXTENDED RELEASE;ORAL~SEROQUEL XR~ASTRAZENECA~EQ 150
MG BASE~N~022047~005~~Aug 11, 2008~No~RX~ASTRAZENECA PHARMACEUTICALS LP
MG BASE~N~022047~002~~May 17, 2007~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
MG BASE~N~022047~003~~May 17, 2007~No~RX~ASTRAZENECA PHARMACEUTICALS LP
MG BASE~N~022047~004~~May 17, 2007~No~RX~ASTRAZENECA PHARMACEUTICALS LP
NIACIN; SIMVASTATIN~TABLET, EXTENDED RELEASE;ORAL~SIMCOR~ABBVIE~1GM;20MG~N~02207
8~003~~Feb 15, 2008~Yes~RX~ABBVIE INC
NIACIN; SIMVASTATIN~TABLET, EXTENDED RELEASE;ORAL~SIMCOR~ABBVIE~1GM;40MG~N~02207
8~005~~Jul 28, 2010~Yes~RX~ABBVIE INC
NIACIN; SIMVASTATIN~TABLET, EXTENDED RELEASE;ORAL~SIMCOR~ABBVIE~500MG;20MG~N~022
078~004~~Jul 28, 2010~Yes~RX~ABBVIE INC
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~SINEMET CR~MERCK SHARP DOHME~2
5MG;100MG~N~019856~002~AB~Dec 24, 1992~No~RX~MERCK SHARP AND DOHME CORP
CARBIDOPA; LEVODOPA~TABLET, EXTENDED RELEASE;ORAL~SINEMET CR~MERCK SHARP DOHME~5
0MG;200MG~N~019856~001~AB~May 30, 1991~Yes~RX~MERCK SHARP AND DOHME CORP
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~SLOW-K~NOVARTIS~8MEQ~N~017476~0
MINOCYCLINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~SOLODYN~MEDICIS~EQ 45MG
BASE~N~050808~001~~May 8, 2006~No~DISCN~MEDICIS PHARMACEUTICAL CORP
BASE~N~050808~008~~Aug 27, 2010~Yes~RX~MEDICIS PHARMACEUTICAL CORP
BASE~N~050808~004~AB~Jul 23, 2009~No~RX~MEDICIS PHARMACEUTICAL CORP
BASE~N~050808~007~AB~Aug 27, 2010~Yes~RX~MEDICIS PHARMACEUTICAL CORP
BASE~N~050808~006~AB~Aug 27, 2010~No~RX~MEDICIS PHARMACEUTICAL CORP
BASE~N~050808~005~AB~Jul 23, 2009~No~RX~MEDICIS PHARMACEUTICAL CORP
PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~SUDAFED 12 HOUR~MCNE
IL CONS~120MG~A~073585~001~~Oct 31, 1991~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~SUDAFED 24 HOUR~MCNE

IL CONS~240MG~N~020021~002~~Dec 15, 1992~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~SULAR~SHIONOGI INC~8.5MG~N~020356~008~
AB~Jan 2, 2008~Yes~RX~SHIONOGI INC
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~SULAR~SHIONOGI INC~10MG **Federal Regi
efficacy reasons**~N~020356~001~~Feb 2, 1995~No~DISCN~SHIONOGI INC
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~SULAR~SHIONOGI INC~17MG~N~020356~007~A
B~Jan 2, 2008~Yes~RX~SHIONOGI INC
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~SULAR~SHIONOGI INC~25.5MG **Federal Re
gister determination that product was not discontinued or withdrawn for safety o
r efficacy reasons**~N~020356~006~~Jan 2, 2008~No~DISCN~SHIONOGI INC
NISOLDIPINE~TABLET, EXTENDED RELEASE;ORAL~SULAR~SHIONOGI INC~34MG~N~020356~005~A
B~Jan 2, 2008~Yes~RX~SHIONOGI INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~SUSTAIRE~ROERIG~100MG~A~085665~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~ROERIG DIV PFIZER INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~SUSTAIRE~ROERIG~300MG~A~085665~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~ROERIG DIV PFIZER INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~T-PHYL~PHARM RES ASSOC~200MG~A~088253
~001~~Aug 17, 1983~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TA
RGINIQ~PURDUE PHARMA LP~5MG;10MG~N~205777~001~~Jul 23, 2014~No~DISCN~PURDUE PHAR
MA LP
RGINIQ~PURDUE PHARMA LP~10MG;20MG~N~205777~002~~Jul 23, 2014~No~DISCN~PURDUE PHA
RMA LP
RGINIQ~PURDUE PHARMA LP~20MG;40MG~N~205777~003~~Jul 23, 2014~No~DISCN~PURDUE PHA
RMA LP
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TARKA~ABBVIE
~1MG;240MG~N~020591~003~AB~Oct 22, 1996~No~RX~ABBVIE INC
~4MG;240MG~N~020591~002~AB~Oct 22, 1996~Yes~RX~ABBVIE INC
DILTIAZEM MALATE; ENALAPRIL MALEATE~TABLET, EXTENDED RELEASE;ORAL~TECZEM~BIOVAIL
~EQ 180MG HCL;5MG~N~020507~001~~Oct 4, 1996~No~DISCN~BIOVAIL LABORATORIES INC
CARBAMAZEPINE~TABLET, EXTENDED RELEASE;ORAL~TEGRETOL-XR~NOVARTIS~100MG~N~020234~
001~AB~Mar 25, 1996~No~RX~NOVARTIS PHARMACEUTICALS CORP
002~AB~Mar 25, 1996~No~RX~NOVARTIS PHARMACEUTICALS CORP
003~AB~Mar 25, 1996~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
POTASSIUM CHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TEN-K~NOVARTIS~10MEQ~N~019381~0
01~~Apr 16, 1986~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
DIETHYLPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TENUATE~SANOFI AVENTI
S US~75MG~N~017669~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US
LLC
DIETHYLPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TENUATE DOSPAN~WATSON
PHARMS~75MG~N~012546~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~WATSON PHARMAC

EUTICALS
DIETHYLPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TEPANIL TEN-TAB~3M~75
MG~N~017956~001~~Approved Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEO-DUR~SCHERING~100MG~A~085328~001~
~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP
~Jun 25, 1986~No~DISCN~SCHERING CORP
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOCHRON~SUN PHARM INDS INC~100MG~A~
088320~001~AB~Feb 21, 1985~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
088321~001~AB~Feb 21, 1985~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
087400~002~~Jan 11, 1983~No~DISCN~SUN PHARMACEUTICAL INDUSTRIES INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOLAIR-SR~3M~200MG~A~088369~001~~Ju
l 16, 1987~No~DISCN~3M PHARMACEUTICALS INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~ABLE~300MG~A~040548~001~
~Apr 30, 2004~No~DISCN~ABLE LABORATORIES INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~ALEMBIC LTD~300MG~A~0904
30~001~AB~Oct 27, 2010~No~RX~ALEMBIC LTD
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~ALEMBIC LTD~450MG~A~0904
30~002~AB~Oct 27, 2010~No~RX~ALEMBIC LTD
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~GLENMARK GENERICS~400MG~
A~090355~001~AB~Jul 13, 2010~No~RX~GLENMARK GENERICS LTD
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~GLENMARK GENERICS~600MG~
A~090355~002~AB~Jul 13, 2010~No~RX~GLENMARK GENERICS LTD
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~INWOOD LABS~450MG~A~0400
34~001~~Apr 28, 1995~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES IN
C
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~NOSTRUM~400MG~A~040595~0
01~AB~Apr 21, 2006~No~RX~NOSTRUM PHARMACEUTICALS INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~NOSTRUM~600MG~A~040560~0
02~AB~Apr 21, 2006~Yes~RX~NOSTRUM PHARMACEUTICALS INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~PLIVA~100MG~A~089807~001
~AB~Apr 30, 1990~Yes~RX~PLIVA INC
~AB~Apr 30, 1990~Yes~RX~PLIVA INC
~AB~Apr 30, 1990~No~RX~PLIVA INC
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~RHODES PHARMS~600MG~A~04
0086~001~AB~Apr 15, 1996~No~RX~RHODES PHARMACEUTICALS LP
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~THEOPHYLLINE~TEVA PHARMS~450MG~A~0812
36~001~AB~Nov 9, 1992~Yes~RX~TEVA PHARMACEUTICALS USA
DILTIAZEM MALATE~TABLET, EXTENDED RELEASE;ORAL~TIAMATE~MERCK~EQ 120MG HCL~N~0205
06~001~~Oct 4, 1996~No~DISCN~MERCK AND CO INC

METOPROLOL SUCCINATE~TABLET, EXTENDED RELEASE;ORAL~TOPROL-XL~ASTRAZENECA PHARMS~
EQ 25MG TARTRATE~N~019962~004~AB~Feb 5, 2001~No~RX~ASTRAZENECA PHARMACEUTICALS L
P
EQ 50MG TARTRATE~N~019962~001~AB~Jan 10, 1992~Yes~RX~ASTRAZENECA PHARMACEUTICALS
LP
EQ 100MG TARTRATE~N~019962~002~AB~Jan 10, 1992~No~RX~ASTRAZENECA PHARMACEUTICALS
LP
EQ 200MG TARTRATE~N~019962~003~AB~Jan 10, 1992~Yes~RX~ASTRAZENECA PHARMACEUTICAL
S LP
FESOTERODINE FUMARATE~TABLET, EXTENDED RELEASE;ORAL~TOVIAZ~PFIZER~4MG~N~022030~0
01~~Oct 31, 2008~No~RX~PFIZER INC
FESOTERODINE FUMARATE~TABLET, EXTENDED RELEASE;ORAL~TOVIAZ~PFIZER~8MG~N~022030~0
02~~Oct 31, 2008~Yes~RX~PFIZER INC
TRAMADOL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TRAMADOL HYDROCHLORIDE~ACTA
VIS ELIZABETH~100MG~A~091609~001~AB2~Jun 27, 2012~No~RX~ACTAVIS ELIZABETH LLC
TRAMADOL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TRAMADOL HYDROCHLORIDE~ANCH
EN PHARMS~100MG~A~200491~001~AB2~Jun 27, 2012~No~RX~ANCHEN PHARMACEUTICALS INC
TRAMADOL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TRAMADOL HYDROCHLORIDE~LUPI
N LTD~100MG~A~200503~001~AB1~Aug 29, 2011~No~RX~LUPIN LTD
TRAMADOL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TRAMADOL HYDROCHLORIDE~PAR
PHARM INC~100MG~A~078783~001~AB1~Nov 13, 2009~No~RX~PAR PHARMACEUTICAL INC
PHARM INC~200MG~A~078783~002~AB1~Nov 13, 2009~No~RX~PAR PHARMACEUTICAL INC
PHARM INC~300MG~A~078783~003~AB1~Sep 20, 2011~No~RX~PAR PHARMACEUTICAL INC
TRAMADOL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TRAMADOL HYDROCHLORIDE~SUN
PHARMA GLOBAL~100MG~A~091607~001~AB2~Dec 30, 2011~Yes~RX~SUN PHARMA GLOBAL FZE
PHARMA GLOBAL~100MG~A~201384~001~AB1~Dec 7, 2011~No~RX~SUN PHARMA GLOBAL FZE
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~TRANDOLAPRIL
AND VERAPAMIL HYDROCHLORIDE~GLENMARK GENERICS~1MG;240MG~A~079135~004~AB~Aug 30,
2010~No~RX~GLENMARK GENERICS LTD

AND VERAPAMIL HYDROCHLORIDE~GLENMARK GENERICS~2MG;180MG~A~079135~001~AB~May 26,
PENTOXIFYLLINE~TABLET, EXTENDED RELEASE;ORAL~TRENTAL~SANOFI AVENTIS US~400MG~N~0
CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE~TABLET, EXTENDED REL
EASE;ORAL~TRIAMINIC-12~NOVARTIS~12MG;75MG~N~018115~001~~Approved Prior to Jan 1,
PERPHENAZINE~TABLET, EXTENDED RELEASE;ORAL~TRILAFON~SCHERING~8MG~N~011361~002~~A
AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE~TABLET, EXTENDED RELEASE;ORAL~TRINALI
N~SCHERING~1MG;120MG~N~018506~001~~Mar 23, 1982~No~DISCN~SCHERING CORP SUB SCHER
ING PLOUGH CORP
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~TABLET, EXTENDED RELEA
SE;ORAL~TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES~KV PHARM~120MG;5MG~A~072
758~001~~Nov 25, 1991~No~DISCN~KV PHARMACEUTICAL CO
ACETAMINOPHEN~TABLET, EXTENDED RELEASE;ORAL~TYLENOL ~MCNEIL CONS~650MG~N~019872~
001~~Jun 8, 1994~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
ACETAMINOPHEN~TABLET, EXTENDED RELEASE;ORAL~TYLENOL ~MCNEIL CONS~650MG~N~019872~
002~~Jan 11, 2001~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
BUDESONIDE~TABLET, EXTENDED RELEASE;ORAL~UCERIS~SANTARUS INC~9MG~N~203634~001~~J
an 14, 2013~Yes~RX~SANTARUS INC
TRAMADOL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ULTRAM ER~VALEANT INTL~100M
G~N~021692~001~AB1~Sep 8, 2005~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
G~N~021692~002~AB1~Sep 8, 2005~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
G~N~021692~003~AB1~Sep 8, 2005~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~UNI-DUR~SCHERING~400MG~A~089822~001~~
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~UNI-DUR~SCHERING~600MG~A~089823~001~~
Jan 4, 1995~No~DISCN~SCHERING CORP
THEOPHYLLINE~TABLET, EXTENDED RELEASE;ORAL~UNIPHYL~RHODES PHARMS~400MG~A~087571~
001~AB~Sep 1, 1982~No~RX~RHODES PHARMACEUTICALS LP
POTASSIUM CITRATE~TABLET, EXTENDED RELEASE;ORAL~UROCIT-K~MISSION PHARMA~5MEQ~N~0
19071~001~AB~Aug 30, 1985~No~RX~MISSION PHARMACAL CO
POTASSIUM CITRATE~TABLET, EXTENDED RELEASE;ORAL~UROCIT-K~MISSION PHARMA~10MEQ~N~
019071~002~AB~Aug 31, 1992~No~RX~MISSION PHARMACAL CO
POTASSIUM CITRATE~TABLET, EXTENDED RELEASE;ORAL~UROCIT-K~MISSION PHARMA~15MEQ~N~
019071~003~AB~Dec 30, 2009~Yes~RX~MISSION PHARMACAL CO
ALFUZOSIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~UROXATRAL~COVIS PHARMA SAR
L~10MG~N~021287~001~AB~Jun 12, 2003~Yes~RX~COVIS PHARMA SARL
VENLAFAXINE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VENLAFAXINE HYDROCHLORID
E~OSMOTICA PHARM~EQ 37.5MG BASE~N~022104~001~AB~May 20, 2008~No~RX~OSMOTICA PHAR
MACEUTICAL CORP
E~OSMOTICA PHARM~EQ 75MG BASE~N~022104~002~AB~May 20, 2008~No~RX~OSMOTICA PHARMA
CEUTICAL CORP
E~OSMOTICA PHARM~EQ 150MG BASE~N~022104~003~AB~May 20, 2008~Yes~RX~OSMOTICA PHAR
MACEUTICAL CORP
E~OSMOTICA PHARM~EQ 225MG BASE~N~022104~004~~May 20, 2008~No~RX~OSMOTICA PHARMAC
EUTICAL CORP

E~SUN PHARMA GLOBAL~EQ 37.5MG BASE~A~091272~001~AB~Aug 18, 2010~No~RX~SUN PHARMA
GLOBAL FZE
E~SUN PHARMA GLOBAL~EQ 75MG BASE~A~091272~002~AB~Aug 18, 2010~No~RX~SUN PHARMA G
LOBAL FZE
E~SUN PHARMA GLOBAL~EQ 150MG BASE~A~091272~003~AB~Aug 18, 2010~No~RX~SUN PHARMA
GLOBAL FZE
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~AP
OTEX CORP~120MG~A~200878~001~AB~Apr 20, 2012~No~RX~APOTEX CORP
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~GL
ENMARK GENERICS~120MG~A~090700~001~AB~Aug 3, 2011~No~RX~GLENMARK GENERICS LTD
ENMARK GENERICS~180MG~A~090700~002~AB~Aug 3, 2011~No~RX~GLENMARK GENERICS LTD
ENMARK GENERICS~240MG~A~078906~001~AB~Sep 17, 2009~No~RX~GLENMARK GENERICS LTD
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~IV
AX SUB TEVA PHARMS~120MG~A~073568~002~AB~Oct 10, 1997~No~RX~IVAX PHARMACEUTICALS
AX SUB TEVA PHARMS~180MG~A~074330~001~AB~Jan 31, 1994~No~RX~IVAX PHARMACEUTICALS
AX SUB TEVA PHARMS~240MG~A~073568~001~AB~Jul 31, 1992~No~RX~IVAX PHARMACEUTICALS
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~MY
LAN~120MG~A~074587~002~AB~Feb 21, 1997~No~RX~MYLAN PHARMACEUTICALS INC
LAN~180MG~A~074587~003~AB~Sep 9, 1997~No~RX~MYLAN PHARMACEUTICALS INC
LAN~240MG~A~074587~001~AB~Mar 23, 1996~No~RX~MYLAN PHARMACEUTICALS INC
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~PA
R PHARM~120MG~A~075072~001~AB~May 25, 1999~No~RX~PAR PHARMACEUTICAL INC
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~PA
R PHARM~240MG~A~075072~003~AB~May 25, 1999~No~RX~PAR PHARMACEUTICAL INC
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~PL
IVA~240MG~A~072922~001~~Mar 1, 1996~No~DISCN~PLIVA INC
VERAPAMIL HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~VERAPAMIL HYDROCHLORIDE~SU
N PHARM INDS INC~120MG~A~090529~001~AB~Dec 30, 2011~No~RX~SUN PHARMACEUTICAL IND
USTRIES INC
USTRIES INC
USTRIES INC
NEVIRAPINE~TABLET, EXTENDED RELEASE;ORAL~VIRAMUNE XR~BOEHRINGER INGELHEIM~100MG~
N~201152~002~~Nov 8, 2012~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
NEVIRAPINE~TABLET, EXTENDED RELEASE;ORAL~VIRAMUNE XR~BOEHRINGER INGELHEIM~400MG~
N~201152~001~AB~Mar 25, 2011~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
ALBUTEROL SULFATE~TABLET, EXTENDED RELEASE;ORAL~VOLMAX~MURO~EQ 4MG BASE~N~019604
~002~~Dec 23, 1992~No~DISCN~MURO PHARMACEUTICAL INC
ALBUTEROL SULFATE~TABLET, EXTENDED RELEASE;ORAL~VOLMAX~MURO~EQ 8MG BASE~N~019604
~001~~Dec 23, 1992~No~DISCN~MURO PHARMACEUTICAL INC
DICLOFENAC SODIUM~TABLET, EXTENDED RELEASE;ORAL~VOLTAREN-XR~NOVARTIS~100MG~N~020
254~001~AB~Mar 8, 1996~Yes~RX~NOVARTIS PHARMACEUTICALS CORP

ALBUTEROL SULFATE~TABLET, EXTENDED RELEASE;ORAL~VOSPIRE ER~DAVA PHARMS INC~EQ 4M
G BASE~A~076130~002~AB~Sep 26, 2002~No~RX~DAVA PHARMACEUTICALS INC
ALBUTEROL SULFATE~TABLET, EXTENDED RELEASE;ORAL~VOSPIRE ER~DAVA PHARMS INC~EQ 8M
G BASE~A~076130~003~AB~Sep 26, 2002~Yes~RX~DAVA PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~WELLBUTRIN SR~GLAXOSMITHKL
INE~50MG~N~020358~001~~Oct 4, 1996~No~DISCN~GLAXOSMITHKLINE
INE~100MG~N~020358~002~AB1~Oct 4, 1996~No~RX~GLAXOSMITHKLINE
INE~150MG~N~020358~003~AB1~Oct 4, 1996~No~RX~GLAXOSMITHKLINE
INE~200MG~N~020358~004~AB1~Jun 14, 2002~Yes~RX~GLAXOSMITHKLINE
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~WELLBUTRIN XL~VALEANT INTL
~150MG~N~021515~001~AB3~Aug 28, 2003~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~WELLBUTRIN XL~VALEANT INTL
~300MG~N~021515~002~AB3~Aug 28, 2003~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~XANAX XR~PHARMACIA AND UPJOHN~0.5MG~N~0
21434~001~AB~Jan 17, 2003~No~RX~PHARMACIA AND UPJOHN
ALPRAZOLAM~TABLET, EXTENDED RELEASE;ORAL~XANAX XR~PHARMACIA AND UPJOHN~1MG~N~021
434~004~AB~Jan 17, 2003~Yes~RX~PHARMACIA AND UPJOHN
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~XARTEMIS XR
~MALLINCKRODT INC~325MG;7.5MG~N~204031~001~~Mar 11, 2014~Yes~RX~MALLINCKRODT INC
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~XIGDUO XR~A
STRAZENECA AB~5MG;1GM~N~205649~002~~Oct 29, 2014~No~RX~ASTRAZENECA AB
STRAZENECA AB~5MG;500MG~N~205649~001~~Oct 29, 2014~No~RX~ASTRAZENECA AB
STRAZENECA AB~10MG;1GM~N~205649~004~~Oct 29, 2014~Yes~RX~ASTRAZENECA AB
STRAZENECA AB~10MG;500MG~N~205649~003~~Oct 29, 2014~No~RX~ASTRAZENECA AB
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~ACTAVIS ELIZAB
ETH~6.25MG~A~078179~002~AB~Oct 13, 2010~No~RX~ACTAVIS ELIZABETH LLC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~ACTAVIS ELIZAB
ETH~12.5MG~A~078179~001~AB~Jun 6, 2011~No~RX~ACTAVIS ELIZABETH LLC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~ACTAVIS LABS F
L INC~6.25MG~A~090153~001~AB~Mar 25, 2013~No~RX~ACTAVIS LABORATORIES FL INC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~ACTAVIS LABS F
L INC~12.5MG~A~090153~002~AB~Mar 25, 2013~No~RX~ACTAVIS LABORATORIES FL INC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~ANCHEN PHARMS~
6.25MG~A~078148~002~AB~Apr 14, 2011~No~RX~ANCHEN PHARMACEUTICALS INC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~ANCHEN PHARMS~
12.5MG~A~078148~001~AB~Dec 3, 2010~No~RX~ANCHEN PHARMACEUTICALS INC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~APOTEX INC~6.2
5MG~A~200266~001~AB~Sep 10, 2013~No~RX~APOTEX INC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~APOTEX INC~12.
5MG~A~200266~002~AB~Sep 10, 2013~No~RX~APOTEX INC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~LUPIN LTD~6.25
MG~A~078970~001~AB~Sep 11, 2013~No~RX~LUPIN LTD
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~LUPIN LTD~12.5
MG~A~078970~002~AB~Sep 11, 2013~No~RX~LUPIN LTD
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~SANDOZ~6.25MG~
A~090107~001~AB~Jul 1, 2011~No~RX~SANDOZ INC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~SANDOZ~12.5MG~
A~090107~002~AB~Jul 1, 2011~No~RX~SANDOZ INC
ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~SYNTHON PHARMS
~6.25MG~A~078483~001~AB~Apr 12, 2011~No~RX~SYNTHON PHARMACEUTICALS INC

ZOLPIDEM TARTRATE~TABLET, EXTENDED RELEASE;ORAL~ZOLPIDEM TARTRATE~SYNTHON PHARMS
~12.5MG~A~078483~002~AB~Jun 6, 2011~No~RX~SYNTHON PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ZYBAN~GLAXOSMITHKLINE~100M
G~N~020711~002~~May 14, 1997~No~DISCN~GLAXOSMITHKLINE
BUPROPION HYDROCHLORIDE~TABLET, EXTENDED RELEASE;ORAL~ZYBAN~GLAXOSMITHKLINE~150M
G~N~020711~003~AB2~May 14, 1997~Yes~RX~GLAXOSMITHKLINE
ZILEUTON~TABLET, EXTENDED RELEASE;ORAL~ZYFLO CR~CHIESI USA INC~600MG~N~022052~00
1~~May 30, 2007~Yes~RX~CHIESI USA INC
;ORAL~ZYRTEC-D 12 HOUR~MCNEIL~5MG;120MG~N~021150~002~~Nov 9, 2007~Yes~OTC~MCNEIL
CONSUMER PRODUCTS CO DIV MCNEILAB INC
EVEROLIMUS~TABLET, FOR SUSPENSION;ORAL~AFINITOR DISPERZ~NOVARTIS PHARM~2MG~N~203
985~001~~Aug 29, 2012~No~RX~NOVARTIS PHARMACEUTICAL CORP
985~002~~Aug 29, 2012~No~RX~NOVARTIS PHARMACEUTICAL CORP
985~003~~Aug 29, 2012~Yes~RX~NOVARTIS PHARMACEUTICAL CORP
AMOXICILLIN~TABLET, FOR SUSPENSION;ORAL~AMOXICILLIN~AUROBINDO PHARMA LTD~200MG~A
~065324~001~~Jan 17, 2007~No~DISCN~AUROBINDO PHARMA LTD
AMOXICILLIN~TABLET, FOR SUSPENSION;ORAL~AMOXICILLIN~AUROBINDO PHARMA LTD~400MG~A
~065324~002~~Jan 17, 2007~No~DISCN~AUROBINDO PHARMA LTD
CARBIDOPA; LEVODOPA~TABLET, FOR SUSPENSION;ORAL~CARBILEV~RANBAXY~10MG;100MG~A~07
6643~001~~Jun 10, 2005~No~DISCN~RANBAXY LABORATORIES LTD
DIDANOSINE~TABLET, FOR SUSPENSION;ORAL~DIDANOSINE~AUROBINDO~100MG~A~077275~001~~
Aug 14, 2012~No~RX~AUROBINDO PHARMA LTD
Aug 14, 2012~No~RX~AUROBINDO PHARMA LTD
Aug 14, 2012~Yes~RX~AUROBINDO PHARMA LTD
AMOXICILLIN~TABLET, FOR SUSPENSION;ORAL~DISPERMOX~RANBAXY LABS LTD~200MG~A~06508
0~002~~Aug 11, 2003~No~DISCN~RANBAXY LABORATORIES LTD
0~001~~Aug 11, 2003~No~DISCN~RANBAXY LABORATORIES LTD
9~001~~Dec 4, 2003~No~DISCN~RANBAXY LABORATORIES LTD
DEFERASIROX~TABLET, FOR SUSPENSION;ORAL~EXJADE~NOVARTIS~125MG~N~021882~001~~Nov
METHADONE HYDROCHLORIDE~TABLET, FOR SUSPENSION;ORAL~METHADONE HYDROCHLORIDE~MALL
INCKRODT INC~40MG~A~077142~001~AA~Jul 12, 2005~No~RX~MALLINCKRODT INC
METHADONE HYDROCHLORIDE~TABLET, FOR SUSPENSION;ORAL~METHADONE HYDROCHLORIDE~ROXA
NE~40MG~N~017058~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~ROXANE LABORATORIES
INC
METHADONE HYDROCHLORIDE~TABLET, FOR SUSPENSION;ORAL~METHADONE HYDROCHLORIDE~SAND
OZ~40MG~A~075082~001~AA~Mar 25, 1998~No~RX~SANDOZ INC
METHADONE HYDROCHLORIDE~TABLET, FOR SUSPENSION;ORAL~METHADOSE~MALLINCKRODT~40MG~
A~074184~001~AA~Apr 29, 1993~No~RX~MALLINCKRODT CHEMICAL INC
CEPHALEXIN~TABLET, FOR SUSPENSION;ORAL~PANIXINE DISPERDOSE~RANBAXY LABS LTD~EQ 1
25MG BASE~A~065100~002~~Sep 11, 2003~No~DISCN~RANBAXY LABORATORIES LTD
CEPHALEXIN~TABLET, FOR SUSPENSION;ORAL~PANIXINE DISPERDOSE~RANBAXY LABS LTD~EQ 2
50MG BASE~A~065100~001~~Sep 11, 2003~No~DISCN~RANBAXY LABORATORIES LTD
ARIPIPRAZOLE~TABLET, ORALLY DISINTEGRATING;ORAL~ABILIFY~OTSUKA~10MG~N~021729~002
~~Jun 7, 2006~Yes~RX~OTSUKA PHARMACEUTICAL CO LTD

ARIPIPRAZOLE~TABLET, ORALLY DISINTEGRATING;ORAL~ABILIFY~OTSUKA~15MG~N~021729~003
~~Jun 7, 2006~No~RX~OTSUKA PHARMACEUTICAL CO LTD
ARIPIPRAZOLE~TABLET, ORALLY DISINTEGRATING;ORAL~ABILIFY~OTSUKA~20MG **Federal Re
r efficacy reasons**~N~021729~004~~Jun 7, 2006~No~DISCN~OTSUKA PHARMACEUTICAL CO
LTD
ARIPIPRAZOLE~TABLET, ORALLY DISINTEGRATING;ORAL~ABILIFY~OTSUKA~30MG **Federal Re
r efficacy reasons**~N~021729~005~~Jun 7, 2006~No~DISCN~OTSUKA PHARMACEUTICAL CO
LTD
LORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~ALAVERT~PFIZER~10MG~N~021375~001~~
Dec 19, 2002~No~OTC~PFIZER INC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~0.25M
G~A~078561~001~AB~Mar 16, 2010~No~RX~ACTAVIS ELIZABETH LLC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~0.5MG
~A~078561~002~AB~Mar 16, 2010~No~RX~ACTAVIS ELIZABETH LLC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~1MG~A
~078561~003~AB~Mar 16, 2010~No~RX~ACTAVIS ELIZABETH LLC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~2MG~A
~078561~004~AB~Mar 16, 2010~No~RX~ACTAVIS ELIZABETH LLC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~ALPRAZOLAM~PAR PHARM~0.25MG~A~0780
88~001~AB~Jan 9, 2009~No~RX~PAR PHARMACEUTICAL INC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~ALPRAZOLAM~PAR PHARM~0.5MG~A~07808
8~002~AB~Jan 9, 2009~No~RX~PAR PHARMACEUTICAL INC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~ALPRAZOLAM~PAR PHARM~1MG~A~078088~
003~AB~Jan 9, 2009~Yes~RX~PAR PHARMACEUTICAL INC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~ALPRAZOLAM~PAR PHARM~2MG~A~078088~
AMLODIPINE BESYLATE~TABLET, ORALLY DISINTEGRATING;ORAL~AMLODIPINE BESYLATE~SYNTH
ON PHARMS~EQ 2.5MG BASE~N~022026~001~~Sep 27, 2007~No~DISCN~SYNTHON PHARMACEUTIC
ALS INC
ON PHARMS~EQ 5MG BASE~N~022026~002~~Sep 27, 2007~No~DISCN~SYNTHON PHARMACEUTICAL
S INC
ON PHARMS~EQ 10MG BASE~N~022026~003~~Sep 27, 2007~No~DISCN~SYNTHON PHARMACEUTICA
LS INC
DONEPEZIL HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~ARICEPT ODT~EISAI INC
~5MG~N~021720~001~AB~Oct 18, 2004~No~RX~EISAI INC
DONEPEZIL HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~ARICEPT ODT~EISAI INC
~10MG~N~021720~002~AB~Oct 18, 2004~Yes~RX~EISAI INC
CARBIDOPA; LEVODOPA~TABLET, ORALLY DISINTEGRATING;ORAL~CARBIDOPA AND LEVODOPA~IM
PAX LABS~10MG;100MG~A~090631~001~~Jun 8, 2010~No~DISCN~IMPAX LABORATORIES INC
CARBIDOPA; LEVODOPA~TABLET, ORALLY DISINTEGRATING;ORAL~CARBIDOPA AND LEVODOPA~MY
LAN~10MG;100MG~A~078893~001~AB~Sep 18, 2008~No~RX~MYLAN PHARMACEUTICALS INC
LAN~25MG;100MG~A~078893~002~AB~Sep 18, 2008~No~RX~MYLAN PHARMACEUTICALS INC
LAN~25MG;250MG~A~078893~003~AB~Sep 18, 2008~Yes~RX~MYLAN PHARMACEUTICALS INC
CARBIDOPA; LEVODOPA~TABLET, ORALLY DISINTEGRATING;ORAL~CARBIDOPA AND LEVODOPA~SU
N PHARMA GLOBAL~10MG;100MG~A~078690~001~AB~Jul 31, 2009~No~RX~SUN PHARMA GLOBAL
FZE
FZE

FZE
FEXOFENADINE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~CHILDREN'S ALLEGRA
ALLERGY~SANOFI AVENTIS US~30MG~N~021909~002~~Jan 24, 2011~Yes~OTC~SANOFI AVENTI
S US LLC
FEXOFENADINE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~CHILDREN'S ALLEGRA
HIVES~SANOFI AVENTIS US~30MG~N~021909~003~~Jan 24, 2011~Yes~OTC~SANOFI AVENTIS
US LLC
FEXOFENADINE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~CHILDREN'S FEXOFEN
ADINE HYDROCHLORIDE ALLERGY~DR REDDYS LABS LTD~30MG~A~202978~001~~Jan 18, 2013~N
o~OTC~DR REDDYS LABORATORIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~CHILDREN'S FEXOFEN
ADINE HYDROCHLORIDE HIVES~DR REDDYS LABS LTD~30MG~A~202978~002~~Jan 18, 2013~No~
OTC~DR REDDYS LABORATORIES LTD
CITALOPRAM HYDROBROMIDE~TABLET, ORALLY DISINTEGRATING;ORAL~CITALOPRAM HYDROBROMI
DE~BIOVAIL LABS INTL~EQ 10MG BASE~N~021763~001~~Dec 20, 2005~No~DISCN~BIOVAIL LA
BORATORIES INTERNATIONAL SRL
DESLORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~CLARINEX~MERCK SHARP DOHME~2.5M
G~N~021312~002~AB~Jul 14, 2005~No~RX~MERCK SHARP AND DOHME CORP
DESLORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~CLARINEX~MERCK SHARP DOHME~5MG~
N~021312~001~AB~Jun 26, 2002~Yes~RX~MERCK SHARP AND DOHME CORP
LORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~CLARITIN HIVES RELIEF REDITAB~BAYE
R HEALTHCARE LLC~10MG~N~020704~003~~Nov 19, 2003~Yes~OTC~BAYER HEALTHCARE LLC
LORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~CLARITIN REDITABS~BAYER HEALTHCARE
LLC~10MG~N~020704~002~~Nov 27, 2002~Yes~OTC~BAYER HEALTHCARE LLC
LORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~CLARITIN REDITABS~SCHERING PLOUGH~
5MG~N~021993~001~~Dec 12, 2006~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~BARR~0.125MG~A~077194~0
~AB~Aug 10, 2005~No~RX~BARR LABORATORIES INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~BARR~1MG~A~077194~004~A
B~Aug 10, 2005~No~RX~BARR LABORATORIES INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~BARR~2MG~A~077194~005~A
B~Aug 10, 2005~No~RX~BARR LABORATORIES INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~PAR PHARM~0.125MG~A~077
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~PAR PHARM~1MG~A~077171~
004~AB~Aug 3, 2005~Yes~RX~PAR PHARMACEUTICAL INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~PAR PHARM~2MG~A~077171~
005~AB~Aug 3, 2005~No~RX~PAR PHARMACEUTICAL INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~SUN PHARM INDS INC~0.12
5MG~A~078654~001~AB~Aug 27, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~SUN PHARM INDS INC~0.25
MG~A~078654~002~AB~Aug 27, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~SUN PHARM INDS INC~0.5M
G~A~078654~003~AB~Aug 27, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~SUN PHARM INDS INC~1MG~

A~078654~004~AB~Aug 27, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~CLONAZEPAM~SUN PHARM INDS INC~2MG~
A~078654~005~AB~Aug 27, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
DESLORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~DESLORATADINE~REDDYS~2.5MG~A~07
8367~001~AB~Jul 12, 2010~No~RX~DOCTOR REDDYS LABORATORIES LTD
DESLORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~DESLORATADINE~REDDYS~5MG~A~0783
67~002~AB~Jul 12, 2010~No~RX~DOCTOR REDDYS LABORATORIES LTD
DONEPEZIL HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~DONEPEZIL HYDROCHLORI
DE~BARR~5MG~A~078388~002~AB~Nov 26, 2010~No~RX~BARR LABORATORIES INC
DE~BARR~10MG~A~078388~001~AB~Nov 26, 2010~No~RX~BARR LABORATORIES INC
DE~MACLEODS PHARMS LTD~5MG~A~201787~001~AB~Dec 14, 2012~No~RX~MACLEODS PHARMACEU
TICALS LTD
DE~MACLEODS PHARMS LTD~10MG~A~201787~002~AB~Dec 14, 2012~No~RX~MACLEODS PHARMACE
UTICALS LTD
DE~MUTUAL PHARM~5MG~A~077975~002~~Dec 11, 2009~No~DISCN~MUTUAL PHARMACEUTICAL CO
MPANY, INC.
DE~MUTUAL PHARM~10MG~A~077975~001~~Dec 11, 2009~No~DISCN~MUTUAL PHARMACEUTICAL C
OMPANY, INC.
DE~SANDOZ~5MG~A~091198~001~AB~May 10, 2011~No~RX~SANDOZ INC
DE~SANDOZ~10MG~A~091198~002~AB~May 10, 2011~No~RX~SANDOZ INC
DE~ZYDUS PHARMS USA INC~5MG~A~090175~001~AB~May 10, 2011~No~RX~ZYDUS PHARMACEUTI
CALS USA INC
DE~ZYDUS PHARMS USA INC~10MG~A~090175~002~AB~May 10, 2011~No~RX~ZYDUS PHARMACEUT
ICALS USA INC
CLOZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~FAZACLO ODT~JAZZ PHARMS III~12.5MG~
N~021590~004~~May 30, 2007~No~RX~JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
CLOZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~FAZACLO ODT~JAZZ PHARMS III~25MG~N~
021590~001~~Feb 10, 2004~No~RX~JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
CLOZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~FAZACLO ODT~JAZZ PHARMS III~50MG~N~
021590~003~~Jun 3, 2005~No~DISCN~JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
CLOZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~FAZACLO ODT~JAZZ PHARMS III~100MG~N
~021590~002~~Feb 10, 2004~Yes~RX~JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
~021590~005~~Jul 9, 2010~No~RX~JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
~021590~006~~Jul 9, 2010~No~RX~JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
FAMOTIDINE~TABLET, ORALLY DISINTEGRATING;ORAL~FLUXID~UCB INC~20MG~N~021712~001~~
Sep 24, 2004~No~DISCN~UCB INC
FAMOTIDINE~TABLET, ORALLY DISINTEGRATING;ORAL~FLUXID~UCB INC~40MG~N~021712~002~~
Sep 24, 2004~No~DISCN~UCB INC
BACLOFEN~TABLET, ORALLY DISINTEGRATING;ORAL~KEMSTRO~UCB INC~10MG~N~021589~001~~O
ct 30, 2003~No~DISCN~UCB INC
BACLOFEN~TABLET, ORALLY DISINTEGRATING;ORAL~KEMSTRO~UCB INC~20MG~N~021589~002~~O
ct 30, 2003~No~DISCN~UCB INC
CLONAZEPAM~TABLET, ORALLY DISINTEGRATING;ORAL~KLONOPIN RAPIDLY DISINTEGRATING~RO
CHE~0.125MG **Federal Register determination that product was not discontinued o
r withdrawn for safety or efficacy reasons**~N~020813~001~~Dec 23, 1997~No~DISCN
CHE~0.25MG **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons**~N~020813~002~~Dec 23, 1997~No~DISCN~

HOFFMANN LA ROCHE INC
CHE~0.5MG **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons**~N~020813~003~~Dec 23, 1997~No~DISCN~H
CHE~1MG **Federal Register determination that product was not discontinued or wi
thdrawn for safety or efficacy reasons**~N~020813~004~~Dec 23, 1997~No~DISCN~HOF
FMANN LA ROCHE INC
CHE~2MG **Federal Register determination that product was not discontinued or wi
thdrawn for safety or efficacy reasons**~N~020813~005~~Dec 23, 1997~No~DISCN~HOF
FMANN LA ROCHE INC
LAMOTRIGINE~TABLET, ORALLY DISINTEGRATING;ORAL~LAMICTAL ODT~GLAXOSMITHKLINE LLC~
25MG~N~022251~001~AB~May 8, 2009~No~RX~GLAXOSMITHKLINE LLC
50MG~N~022251~002~AB~May 8, 2009~Yes~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET, ORALLY DISINTEGRATING;ORAL~LAMOTRIGINE~IMPAX LABS INC~25MG~A
~200828~001~AB~Jul 15, 2013~No~RX~IMPAX LABORATORIES INC
LAMOTRIGINE~TABLET, ORALLY DISINTEGRATING;ORAL~LAMOTRIGINE~IMPAX LABS INC~50MG~A
~200828~002~AB~Jul 15, 2013~No~RX~IMPAX LABORATORIES INC
LAMOTRIGINE~TABLET, ORALLY DISINTEGRATING;ORAL~LAMOTRIGINE~IMPAX LABS INC~100MG~
A~200828~003~AB~Jul 15, 2013~No~RX~IMPAX LABORATORIES INC
LAMOTRIGINE~TABLET, ORALLY DISINTEGRATING;ORAL~LAMOTRIGINE~IMPAX LABS INC~200MG~
A~200828~004~AB~Jul 15, 2013~No~RX~IMPAX LABORATORIES INC
LORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~LORATADINE~ACTAVIS LABS FL INC~10M
G~A~075990~001~~Nov 3, 2003~No~OTC~ACTAVIS LABORATORIES FL INC
LORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~LORATADINE~IMPAX LABS~10MG~A~07601
1~001~~Sep 29, 2003~No~OTC~IMPAX LABORATORIES INC
LORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~LORATADINE~PFIZER~10MG~A~075822~00
1~~Feb 10, 2003~No~OTC~PFIZER INC
LORATADINE~TABLET, ORALLY DISINTEGRATING;ORAL~LORATADINE REDIDOSE~RANBAXY~10MG~A
~077153~001~~Apr 11, 2007~No~OTC~RANBAXY LABORATORIES LTD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~MAXALT-MLT~MERCK~EQ 5MG
BASE~N~020865~001~AB~Jun 29, 1998~No~RX~MERCK AND CO INC
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~MAXALT-MLT~MERCK~EQ 10MG
BASE~N~020865~002~AB~Jun 29, 1998~Yes~RX~MERCK AND CO INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~METOCLOPRAMIDE H
YDROCHLORIDE~NOVEL LABS INC~EQ 5MG BASE~A~202191~001~AB~Aug 15, 2014~No~RX~NOVEL
LABORATORIES INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~METOCLOPRAMIDE H
YDROCHLORIDE~NOVEL LABS INC~EQ 10MG BASE~A~202191~002~~Aug 15, 2014~No~RX~NOVEL
LABORATORIES INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~METOZOLV ODT~SAL
IX PHARMS~EQ 5MG BASE~N~022246~001~AB~Sep 4, 2009~Yes~RX~SALIX PHARMACEUTICALS I
NC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~METOZOLV ODT~SAL
IX PHARMS~EQ 10MG BASE **Federal Register determination that product was not dis
continued or withdrawn for safety or efficacy reasons**~N~022246~002~~Sep 4, 200
9~No~DISCN~SALIX PHARMACEUTICALS INC
MIRTAZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~MIRTAZAPINE~ACTAVIS ELIZABETH~15M
G~A~076689~001~~Aug 31, 2005~No~DISCN~ACTAVIS ELIZABETH LLC
G~A~077959~001~~Feb 14, 2011~No~DISCN~ACTAVIS ELIZABETH LLC

MIRTAZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~MIRTAZAPINE~ACTAVIS LABS FL INC~1
5MG~A~076307~001~AB~Dec 17, 2003~No~RX~ACTAVIS LABORATORIES FL INC
0MG~A~076307~002~AB~Dec 17, 2003~No~RX~ACTAVIS LABORATORIES FL INC
5MG~A~076307~003~AB~Feb 28, 2006~No~RX~ACTAVIS LABORATORIES FL INC
MIRTAZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~MIRTAZAPINE~AUROBINDO PHARMA LTD~
15MG~A~077376~002~AB~Dec 8, 2005~No~RX~AUROBINDO PHARMA LTD INC
30MG~A~077376~003~AB~Dec 8, 2005~No~RX~AUROBINDO PHARMA LTD INC
45MG~A~077376~004~AB~Feb 28, 2006~No~RX~AUROBINDO PHARMA LTD INC
MIRTAZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~MIRTAZAPINE~TEVA~15MG~A~076901~00
1~AB~Jun 28, 2005~No~RX~TEVA PHARMACEUTICALS USA INC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~NIRAVAM~UCB INC~0.25MG **Federal R
or efficacy reasons**~N~021726~001~~Jan 19, 2005~No~DISCN~UCB INC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~NIRAVAM~UCB INC~0.5MG **Federal Re
r efficacy reasons**~N~021726~002~~Jan 19, 2005~No~DISCN~UCB INC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~NIRAVAM~UCB INC~1MG **Federal Regi
efficacy reasons**~N~021726~003~~Jan 19, 2005~No~DISCN~UCB INC
ALPRAZOLAM~TABLET, ORALLY DISINTEGRATING;ORAL~NIRAVAM~UCB INC~2MG **Federal Regi
efficacy reasons**~N~021726~004~~Jan 19, 2005~No~DISCN~UCB INC
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~APOTEX INC~5MG~A~091265
~001~AB~Oct 24, 2011~No~RX~APOTEX INC
5~002~AB~Oct 24, 2011~No~RX~APOTEX INC
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~AUROBINDO PHARMA LTD~5M
G~A~203708~001~AB~May 15, 2014~No~RX~AUROBINDO PHARMA LTD
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~AUROBINDO PHARMA LTD~10
MG~A~203708~002~AB~May 15, 2014~No~RX~AUROBINDO PHARMA LTD
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~BARR LABS INC~5MG~A~077
243~001~AB~Jan 30, 2012~No~RX~BARR LABORATORIES INC

OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~DR REDDYS LABS LTD~5MG~
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~DR REDDYS LABS LTD~10MG
~A~076534~002~AB~Oct 24, 2011~No~RX~DR REDDYS LABORATORIES LTD
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~JUBILANT GENERICS~5MG~A
~200221~001~AB~Sep 12, 2012~No~RX~JUBILANT GENERICS LTD
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~JUBILANT GENERICS~10MG~
A~200221~002~AB~Sep 12, 2012~No~RX~JUBILANT GENERICS LTD
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~MACLEODS PHARMS LTD~5MG
~A~203044~001~AB~Feb 20, 2015~No~RX~MACLEODS PHARMACEUTICALS LTD
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~MACLEODS PHARMS LTD~10M
G~A~203044~002~AB~Feb 20, 2015~No~RX~MACLEODS PHARMACEUTICALS LTD
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~MYLAN PHARMS INC~5MG~A~
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~MYLAN PHARMS INC~10MG~A
~202285~002~AB~May 12, 2014~No~RX~MYLAN PHARMACEUTICALS INC
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~ORCHID HLTHCARE~5MG~A~2
02937~001~AB~Mar 2, 2015~No~RX~ORCHID HEALTHCARE
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~ORCHID HLTHCARE~10MG~A~
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~PAR PHARM~5MG~A~078109~
001~AB~Oct 24, 2011~No~RX~PAR PHARMACEUTICAL INC
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~PAR PHARM~10MG~A~078109
~002~AB~Oct 24, 2011~No~RX~PAR PHARMACEUTICAL INC
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~SUN PHARM INDS~5MG~A~09
0881~001~AB~Feb 28, 2012~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~TORRENT PHARMS LLC~5MG~
A~091415~001~AB~Oct 25, 2011~No~RX~TORRENT PHARMACEUTICALS LLC
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~OLANZAPINE~TORRENT PHARMS LLC~10MG
~A~091415~002~AB~Oct 25, 2011~No~RX~TORRENT PHARMACEUTICALS LLC

ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~AUROBINDO PHARMA~4MG~
A~090469~001~AB~Apr 12, 2010~No~RX~AUROBINDO PHARMA LTD
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~AUROBINDO PHARMA~8MG~
A~090469~002~AB~Apr 12, 2010~No~RX~AUROBINDO PHARMA LTD
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~BARR~4MG~A~076693~001
~AB~Jun 25, 2007~No~RX~BARR LABORATORIES INC
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~BARR~8MG~A~076693~002
~AB~Jun 25, 2007~No~RX~BARR LABORATORIES INC
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~GLENMARK GENERICS~4MG
~A~078152~001~AB~Jun 27, 2007~No~RX~GLENMARK GENERICS LTD
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~GLENMARK GENERICS~8MG
~A~078152~002~AB~Jun 27, 2007~No~RX~GLENMARK GENERICS LTD
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~MYLAN~4MG~A~078139~00
1~AB~Jun 25, 2007~No~RX~MYLAN PHARMACEUTICALS INC
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~MYLAN~8MG~A~078139~00
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~NESHER PHARMS~4MG~A~0
77717~001~~Jun 25, 2007~No~DISCN~NESHER PHARMACEUTICALS USA LLC
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~NESHER PHARMS~8MG~A~0
77717~002~~Jun 25, 2007~No~DISCN~NESHER PHARMACEUTICALS USA LLC
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~PAR PHARM~4MG~A~07650
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~RANBAXY~4MG~A~078602~
001~AB~Feb 24, 2011~No~RX~RANBAXY LABORATORIES LTD
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~RANBAXY~8MG~A~078602~
002~AB~Feb 24, 2011~No~RX~RANBAXY LABORATORIES LTD
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~SANDOZ~4MG~A~078050~0
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~SANDOZ~8MG~A~078050~0
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~SUN PHARM INDS~4MG~A~
077557~001~AB~Aug 2, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~SUN PHARM INDS~8MG~A~
077557~002~AB~Aug 2, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~TEVA~4MG~A~076810~001
~AB~Jun 25, 2007~No~RX~TEVA PHARMACEUTICALS USA INC
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ONDANSETRON~TEVA~8MG~A~076810~002
PREDNISOLONE SODIUM PHOSPHATE~TABLET, ORALLY DISINTEGRATING;ORAL~ORAPRED ODT~CON
CORDIA PHARMS INC~EQ 10MG BASE~N~021959~001~AB~Jun 1, 2006~No~RX~CONCORDIA PHARM
ACEUTICALS INC
CORDIA PHARMS INC~EQ 15MG BASE~N~021959~002~AB~Jun 1, 2006~No~RX~CONCORDIA PHARM
ACEUTICALS INC
CORDIA PHARMS INC~EQ 30MG BASE~N~021959~003~AB~Jun 1, 2006~Yes~RX~CONCORDIA PHAR
MACEUTICALS INC
CARBIDOPA; LEVODOPA~TABLET, ORALLY DISINTEGRATING;ORAL~PARCOPA~UCB INC~10MG;100M
G **Federal Register determination that product was not discontinued or withdraw
n for safety or efficacy reasons**~A~076699~001~~Aug 27, 2004~No~DISCN~UCB INC

FAMOTIDINE~TABLET, ORALLY DISINTEGRATING;ORAL~PEPCID RPD~MERCK~20MG~N~020752~001
~~May 28, 1998~No~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
FAMOTIDINE~TABLET, ORALLY DISINTEGRATING;ORAL~PEPCID RPD~MERCK~40MG~N~020752~002
~~May 28, 1998~No~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
PREDNISOLONE SODIUM PHOSPHATE~TABLET, ORALLY DISINTEGRATING;ORAL~PREDNISOLONE SO
DIUM PHOSPHATE~MYLAN PHARMS INC~EQ 10MG BASE~A~202179~001~AB~Apr 10, 2013~No~RX~
CISAPRIDE MONOHYDRATE~TABLET, ORALLY DISINTEGRATING;ORAL~PROPULSID QUICKSOLV~JAN
SSEN PHARMA~EQ 20MG BASE~N~020767~001~~Nov 7, 1997~No~DISCN~JANSSEN PHARMACEUTIC
A PRODUCTS LP
METOCLOPRAMIDE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~REGLAN ODT~MEDA
PHARMS~EQ 5MG BASE~N~021793~001~~Jun 10, 2005~No~DISCN~MEDA PHARMACEUTICALS INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~REGLAN ODT~MEDA
PHARMS~EQ 10MG BASE~N~021793~002~~Jun 10, 2005~No~DISCN~MEDA PHARMACEUTICALS INC
MIRTAZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~REMERON SOLTAB~ORGANON USA INC~15
MG~N~021208~001~AB~Jan 12, 2001~Yes~RX~ORGANON USA INC
MG~N~021208~002~AB~Jan 12, 2001~No~RX~ORGANON USA INC
MG~N~021208~003~AB~Jan 12, 2001~No~RX~ORGANON USA INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERDAL~JANSSEN PHARMS~0.5MG~N~
021444~001~AB~Apr 2, 2003~No~RX~JANSSEN PHARMACEUTICALS INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERDAL~JANSSEN PHARMS~1MG~N~02
1444~002~AB~Apr 2, 2003~Yes~RX~JANSSEN PHARMACEUTICALS INC
1444~003~AB~Apr 2, 2003~No~RX~JANSSEN PHARMACEUTICALS INC
1444~004~AB~Dec 23, 2004~No~RX~JANSSEN PHARMACEUTICALS INC
1444~005~AB~Dec 23, 2004~No~RX~JANSSEN PHARMACEUTICALS INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~ACTAVIS LABS FL INC~0
.5MG~A~076996~001~AB~Apr 19, 2011~No~RX~ACTAVIS LABORATORIES FL INC
MG~A~076996~002~AB~Apr 19, 2011~No~RX~ACTAVIS LABORATORIES FL INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~DR REDDYS LABS LTD~0.
5MG~A~077328~001~AB~Feb 24, 2009~No~RX~DR REDDYS LABORATORIES LTD
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~DR REDDYS LABS LTD~1M
G~A~077328~002~AB~Oct 5, 2009~No~RX~DR REDDYS LABORATORIES LTD
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~DR REDDYS LABS LTD~2M
G~A~077328~003~AB~Feb 24, 2009~No~RX~DR REDDYS LABORATORIES LTD
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~JUBILANT GENERICS~0.5
MG~A~090839~001~AB~Nov 4, 2011~No~RX~JUBILANT GENERICS LTD

RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~JUBILANT GENERICS~1MG
~A~090839~002~AB~Nov 4, 2011~No~RX~JUBILANT GENERICS LTD
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~MYLAN PHARMS INC~0.25
MG~A~091537~006~AB~Feb 12, 2013~No~RX~MYLAN PHARMACEUTICALS INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~MYLAN PHARMS INC~0.5M
G~A~091537~001~AB~Mar 30, 2011~No~RX~MYLAN PHARMACEUTICALS INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~MYLAN PHARMS INC~1MG~
A~091537~002~AB~Mar 30, 2011~No~RX~MYLAN PHARMACEUTICALS INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~PAR PHARM~0.25MG~A~07
7494~001~AB~Apr 30, 2009~No~RX~PAR PHARMACEUTICAL INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~PAR PHARM~0.5MG~A~077
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~PAR PHARM~1MG~A~07749
4~003~AB~Oct 26, 2009~No~RX~PAR PHARMACEUTICAL INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~RANBAXY~0.5MG~A~07754
2~001~AB~Aug 6, 2010~No~RX~RANBAXY LABORATORIES INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~RANBAXY~1MG~A~077542~
002~AB~Aug 6, 2010~No~RX~RANBAXY LABORATORIES INC
003~AB~Aug 6, 2010~No~RX~RANBAXY LABORATORIES INC
001~AB~Aug 6, 2010~No~RX~RANBAXY LABORATORIES LTD
002~AB~Aug 6, 2010~No~RX~RANBAXY LABORATORIES LTD
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~SANDOZ~0.5MG~A~078116
~001~AB~Dec 22, 2009~No~RX~SANDOZ INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~SANDOZ~1MG~A~078116~0
02~AB~Dec 22, 2009~No~RX~SANDOZ INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~SUN PHARM INDS LTD~0.
5MG~A~078464~001~AB~Apr 8, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~SUN PHARM INDS LTD~1M
G~A~078464~002~AB~Apr 8, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD

RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~TEVA~0.5MG~A~076908~0
01~AB~Mar 12, 2012~No~RX~TEVA PHARMACEUTICALS USA INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~TEVA~1MG~A~076908~002
~AB~Mar 12, 2012~No~RX~TEVA PHARMACEUTICALS USA INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~TEVA~2MG~A~076908~003
~AB~Mar 12, 2012~No~RX~TEVA PHARMACEUTICALS USA INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~ZYDUS PHARMS USA~0.5M
G~A~078516~001~AB~May 1, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
RISPERIDONE~TABLET, ORALLY DISINTEGRATING;ORAL~RISPERIDONE~ZYDUS PHARMS USA~2MG~
A~078516~003~AB~May 1, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~APO
TEX INC~EQ 5MG BASE~A~202477~001~AB~Jul 1, 2013~No~RX~APOTEX INC
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~APO
TEX INC~EQ 10MG BASE~A~202477~002~AB~Jul 1, 2013~No~RX~APOTEX INC
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~AUR
OBINDO PHARMA LTD~EQ 5MG BASE~A~203062~001~AB~Jul 1, 2013~No~RX~AUROBINDO PHARMA
LTD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~AUR
OBINDO PHARMA LTD~EQ 10MG BASE~A~203062~002~AB~Jul 1, 2013~No~RX~AUROBINDO PHARM
A LTD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~GLE
NMARK GENERICS~EQ 5MG BASE~A~201914~001~AB~Jul 1, 2013~No~RX~GLENMARK GENERICS L
TD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~GLE
NMARK GENERICS~EQ 10MG BASE~A~201914~002~AB~Jul 1, 2013~No~RX~GLENMARK GENERICS
LTD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~MAC
LEODS PHARMS LTD~EQ 5MG BASE~A~203146~001~AB~Sep 19, 2014~No~RX~MACLEODS PHARMAC
EUTICALS LTD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~MAC
LEODS PHARMS LTD~EQ 10MG BASE~A~203146~002~AB~Sep 19, 2014~No~RX~MACLEODS PHARMA
CEUTICALS LTD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~MYL
AN PHARMS INC~EQ 5MG BASE~A~078173~001~AB~Dec 31, 2012~No~RX~MYLAN PHARMACEUTICA
LS INC
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~MYL
AN PHARMS INC~EQ 10MG BASE~A~078173~002~AB~Dec 31, 2012~No~RX~MYLAN PHARMACEUTIC
ALS INC
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~NAT
CO PHARMA LTD~EQ 5MG BASE~A~203478~001~AB~Jul 1, 2013~No~RX~NATCO PHARMA LTD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~NAT
CO PHARMA LTD~EQ 10MG BASE~A~203478~002~AB~Jul 1, 2013~No~RX~NATCO PHARMA LTD
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~SAN
DOZ~EQ 5MG BASE~A~078739~001~AB~Jul 1, 2013~No~RX~SANDOZ INC
RIZATRIPTAN BENZOATE~TABLET, ORALLY DISINTEGRATING;ORAL~RIZATRIPTAN BENZOATE~SAN
DOZ~EQ 10MG BASE~A~078739~002~AB~Jul 1, 2013~No~RX~SANDOZ INC
TRAMADOL HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~RYBIX ODT~SHIONOGI INC
~50MG~N~021693~001~~May 5, 2005~No~DISCN~SHIONOGI INC
SIMVASTATIN~TABLET, ORALLY DISINTEGRATING;ORAL~SIMVASTATIN~SYNTHON PHARMS~10MG~N
~021961~001~~Oct 9, 2007~No~DISCN~SYNTHON PHARMACEUTICALS LTD
VARDENAFIL HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~STAXYN~BAYER HLTHCAR
E~10MG~N~200179~001~~Jun 17, 2010~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC

PHENTERMINE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~SUPRENZA~CITIUS PHA
RMS~15MG~N~202088~001~~Jun 13, 2011~No~RX~CITIUS PHARMACEUTICALS LLC
RMS~30MG~N~202088~002~~Jun 13, 2011~No~RX~CITIUS PHARMACEUTICALS LLC
RMS~37.5MG~N~202088~003~~Mar 27, 2012~Yes~RX~CITIUS PHARMACEUTICALS LLC
ZOLPIDEM TARTRATE~TABLET, ORALLY DISINTEGRATING;ORAL~TOVALT ODT~BIOVAIL LABS INT
L~5MG~N~021412~001~~Apr 25, 2007~No~DISCN~BIOVAIL LABORATORIES INTERNATIONAL SRL
ZOLPIDEM TARTRATE~TABLET, ORALLY DISINTEGRATING;ORAL~TOVALT ODT~BIOVAIL LABS INT
L~10MG~N~021412~002~~Apr 25, 2007~No~DISCN~BIOVAIL LABORATORIES INTERNATIONAL SR
L
SELEGILINE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~ZELAPAR~VALEANT PHAR
M INTL~1.25MG~N~021479~001~~Jun 14, 2006~Yes~RX~VALEANT PHARMACEUTICALS INTERNAT
IONAL
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ZOFRAN ODT~GLAXOSMITHKLINE~4MG~N~
020781~001~AB~Jan 27, 1999~No~RX~GLAXOSMITHKLINE
ONDANSETRON~TABLET, ORALLY DISINTEGRATING;ORAL~ZOFRAN ODT~GLAXOSMITHKLINE~8MG~N~
020781~002~AB~Jan 27, 1999~Yes~RX~GLAXOSMITHKLINE
ZOLMITRIPTAN~TABLET, ORALLY DISINTEGRATING;ORAL~ZOLMITRIPTAN~APOTEX INC~2.5MG~A~
202476~001~AB~May 14, 2013~No~RX~APOTEX INC
ZOLMITRIPTAN~TABLET, ORALLY DISINTEGRATING;ORAL~ZOLMITRIPTAN~APOTEX INC~5MG~A~20
ZOLMITRIPTAN~TABLET, ORALLY DISINTEGRATING;ORAL~ZOLMITRIPTAN~GLENMARK GENERICS~2
.5MG~A~202560~001~AB~May 14, 2013~No~RX~GLENMARK GENERICS LTD
ZOLMITRIPTAN~TABLET, ORALLY DISINTEGRATING;ORAL~ZOLMITRIPTAN~GLENMARK GENERICS~5
MG~A~202560~002~AB~May 14, 2013~No~RX~GLENMARK GENERICS LTD
ZOLMITRIPTAN~TABLET, ORALLY DISINTEGRATING;ORAL~ZOLMITRIPTAN~ZYDUS PHARMS USA IN
C~2.5MG~A~202890~001~AB~May 15, 2013~No~RX~ZYDUS PHARMACEUTICALS USA INC
ZOLMITRIPTAN~TABLET, ORALLY DISINTEGRATING;ORAL~ZOLMITRIPTAN~ZYDUS PHARMS USA IN
C~5MG~A~202890~002~AB~May 15, 2013~No~RX~ZYDUS PHARMACEUTICALS USA INC
ZOLMITRIPTAN~TABLET, ORALLY DISINTEGRATING;ORAL~ZOMIG-ZMT~ASTRAZENECA~2.5MG~N~02
1231~001~AB~Feb 13, 2001~No~RX~ASTRAZENECA PHARMACEUTICALS LP
ZOLMITRIPTAN~TABLET, ORALLY DISINTEGRATING;ORAL~ZOMIG-ZMT~ASTRAZENECA~5MG~N~0212
31~002~AB~Sep 17, 2001~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~ZYPREXA ZYDIS~LILLY~5MG~N~021086~0
01~AB~Apr 6, 2000~Yes~RX~ELI LILLY AND CO
OLANZAPINE~TABLET, ORALLY DISINTEGRATING;ORAL~ZYPREXA ZYDIS~LILLY~10MG~N~021086~
002~AB~Apr 6, 2000~No~RX~ELI LILLY AND CO
CETIRIZINE HYDROCHLORIDE~TABLET, ORALLY DISINTEGRATING;ORAL~ZYRTEC ALLERGY~MCNEI
L CONSUMER~10MG~N~022578~001~~Sep 3, 2010~Yes~OTC~MCNEIL CONSUMER HEALTHCARE DIV
MCNEIL PPC INC
ASPIRIN; PRAVASTATIN SODIUM~TABLET, TABLET, TABLET;ORAL~PRAVIGARD PAC (COPACKAGE
D)~BRISTOL MYERS SQUIBB~81MG,N/A;N/A,20MG~N~021387~001~~Jun 24, 2003~No~DISCN~BR
ISTOL MYERS SQUIBB CO
D)~BRISTOL MYERS SQUIBB~325MG,N/A;N/A,20MG~N~021387~004~~Jun 24, 2003~No~DISCN~B
RISTOL MYERS SQUIBB CO
D)~BRISTOL MYERS SQUIBB~325MG,N/A;N/A,40MG~N~021387~005~~Jun 24, 2003~No~DISCN~B
RISTOL MYERS SQUIBB CO

CALCIUM CARBONATE; RISEDRONATE SODIUM~TABLET, TABLET;ORAL~ACTONEL WITH CALCIUM (
COPACKAGED)~WARNER CHILCOTT~EQ 500MG BASE,N/A;N/A,35MG **Federal Register determ
ination that product was not discontinued or withdrawn for safety or efficacy re
asons**~N~021823~001~~Aug 12, 2005~No~DISCN~WARNER CHILCOTT CO LLC
ASPIRIN; PRAVASTATIN SODIUM~TABLET, TABLET;ORAL~PRAVIGARD PAC (COPACKAGED)~BRIST
OL MYERS SQUIBB~325MG,N/A;N/A,80MG~N~021387~006~~Jun 24, 2003~No~DISCN~BRISTOL M
YERS SQUIBB CO
DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR~TABLET, TABLET;ORAL~VIEKI
RA PAK (COPACKAGED)~ABBVIE INC~EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG~N
~206619~001~~Dec 19, 2014~Yes~RX~ABBVIE INC
METHYLTESTOSTERONE~TABLET;BUCCAL~ANDROID 5~VALEANT PHARM INTL~5MG~A~087222~001~~
Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
MICONAZOLE~TABLET;BUCCAL~ORAVIG~BIOALLIANCE PHARMA~50MG~N~022404~001~~Apr 16, 20
10~Yes~RX~BIOALLIANCE PHARMA
METHYLTESTOSTERONE~TABLET;BUCCAL~ORETON~SCHERING~10MG~A~080281~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
ACYCLOVIR~TABLET;BUCCAL~SITAVIG~INNOCUTIS HOLDINGS~50MG~N~203791~001~~Apr 12, 20
13~Yes~RX~INNOCUTIS HOLDINGS LLC
FENTANYL CITRATE~TABLET;BUCCAL, SUBLINGUAL~FENTANYL CITRATE~WATSON LABS~EQ 0.1MG
BASE~A~079075~001~~Jan 7, 2011~No~DISCN~WATSON LABORATORIES INC
FENTANYL CITRATE~TABLET;BUCCAL, SUBLINGUAL~FENTORA~CEPHALON~EQ 0.1MG BASE~N~0219
47~001~~Sep 25, 2006~No~RX~CEPHALON INC
47~006~~Mar 2, 2007~No~DISCN~CEPHALON INC
47~003~~Sep 25, 2006~Yes~RX~CEPHALON INC
METHYLTESTOSTERONE~TABLET;BUCCAL, SUBLINGUAL~METANDREN~NOVARTIS~5MG~N~003240~004
~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
METHYLTESTOSTERONE~TABLET;BUCCAL, SUBLINGUAL~METHYLTESTOSTERONE~IMPAX LABS~10MG~
A~084287~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
METHYLTESTOSTERONE~TABLET;BUCCAL, SUBLINGUAL~METHYLTESTOSTERONE~LILLY~10MG~A~080
METHYLTESTOSTERONE~TABLET;BUCCAL, SUBLINGUAL~METHYLTESTOSTERONE~LILLY~25MG~A~080
METHYLTESTOSTERONE~TABLET;BUCCAL, SUBLINGUAL~METHYLTESTOSTERONE~PUREPAC PHARM~10
MG~A~080308~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL C
O
O
O
O
METHYLTESTOSTERONE~TABLET;BUCCAL, SUBLINGUAL~METHYLTESTOSTERONE~PVT FORM~5MG~A~0
83836~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
METHYLTESTOSTERONE~TABLET;BUCCAL, SUBLINGUAL~METHYLTESTOSTERONE~TABLICAPS~10MG~A
~085125~001~~Approved Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
METHYLTESTOSTERONE~TABLET;BUCCAL, SUBLINGUAL~METHYLTESTOSTERONE~USL PHARMA~10MG~
A~080271~001~~Approved Prior to Jan 1, 1982~No~DISCN~USL PHARMA INC
CHLORHEXIDINE GLUCONATE~TABLET;DENTAL~PERIOCHIP~DEXCEL PHARMA~2.5MG~N~020774~001
~~May 15, 1998~Yes~RX~DEXCEL PHARMA TECHNOLOGIES LTD
ABACAVIR SULFATE~TABLET;ORAL~ABACAVIR SULFATE~APOTEX INC~EQ 300MG BASE~A~201570~
001~AB~Dec 17, 2012~No~RX~APOTEX INC
ABACAVIR SULFATE~TABLET;ORAL~ABACAVIR SULFATE~AUROBINDO PHARMA LTD~EQ 300MG BASE
~A~077844~001~AB~Dec 17, 2012~No~RX~AUROBINDO PHARMA LTD
ABACAVIR SULFATE~TABLET;ORAL~ABACAVIR SULFATE~HETERO LABS LTD III~EQ 300MG BASE~
A~091560~001~AB~Sep 13, 2013~No~RX~HETERO LABS LTD UNIT III
ABACAVIR SULFATE~TABLET;ORAL~ABACAVIR SULFATE~MYLAN PHARMS INC~EQ 300MG BASE~A~0
91294~001~AB~Jun 18, 2012~No~RX~MYLAN PHARMACEUTICALS INC
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE~TABLET;ORAL~ABACAVIR SULFATE, LAMIVUDIN
E AND ZIDOVUDINE~LUPIN LTD~EQ 300MG BASE;150MG;300MG~A~202912~001~AB~Dec 5, 2013
~No~RX~LUPIN LTD
ARIPIPRAZOLE~TABLET;ORAL~ABILIFY~OTSUKA~2MG~N~021436~006~~Nov 15, 2002~No~RX~OTS
UKA PHARMACEUTICAL CO LTD
ARIPIPRAZOLE~TABLET;ORAL~ABILIFY~OTSUKA~5MG~N~021436~005~~Nov 15, 2002~Yes~RX~OT
SUKA PHARMACEUTICAL CO LTD
ARIPIPRAZOLE~TABLET;ORAL~ABILIFY~OTSUKA~10MG~N~021436~001~~Nov 15, 2002~Yes~RX~O
TSUKA PHARMACEUTICAL CO LTD
ARIPIPRAZOLE~TABLET;ORAL~ABILIFY~OTSUKA~15MG~N~021436~002~~Nov 15, 2002~No~RX~OT
ACARBOSE~TABLET;ORAL~ACARBOSE~EMCURE PHARMS LTD~25MG~A~202271~001~AB~Feb 7, 2012
~No~RX~EMCURE PHARMACEUTICALS LTD
~No~RX~EMCURE PHARMACEUTICALS LTD
2~No~RX~EMCURE PHARMACEUTICALS LTD
ACARBOSE~TABLET;ORAL~ACARBOSE~IMPAX LABS~25MG~A~078441~001~AB~May 14, 2009~No~RX
~IMPAX LABORATORIES INC
ACARBOSE~TABLET;ORAL~ACARBOSE~IMPAX LABS~50MG~A~078441~002~AB~May 14, 2009~No~RX
ACARBOSE~TABLET;ORAL~ACARBOSE~IMPAX LABS~100MG~A~078441~003~AB~May 14, 2009~No~R
X~IMPAX LABORATORIES INC
ACARBOSE~TABLET;ORAL~ACARBOSE~MYLAN~25MG~A~091053~001~AB~Jan 6, 2011~No~RX~MYLAN
PHARMACEUTICALS INC
ACARBOSE~TABLET;ORAL~ACARBOSE~MYLAN~50MG~A~091053~002~AB~Jan 6, 2011~No~RX~MYLAN
PHARMACEUTICALS INC
ACARBOSE~TABLET;ORAL~ACARBOSE~MYLAN~100MG~A~091053~003~AB~Jan 6, 2011~No~RX~MYLA
ACARBOSE~TABLET;ORAL~ACARBOSE~ROXANE~25MG~A~078470~001~AB~May 7, 2008~No~RX~ROXA
NE LABORATORIES INC
ACARBOSE~TABLET;ORAL~ACARBOSE~ROXANE~50MG~A~078470~002~AB~May 7, 2008~No~RX~ROXA
NE LABORATORIES INC
ACARBOSE~TABLET;ORAL~ACARBOSE~ROXANE~100MG~A~078470~003~AB~May 7, 2008~No~RX~ROX
ACARBOSE~TABLET;ORAL~ACARBOSE~STRIDES PHARMA~25MG~A~090912~001~AB~Jul 27, 2011~N
o~RX~STRIDES PHARMA GLOBAL PTE LTD
ACARBOSE~TABLET;ORAL~ACARBOSE~STRIDES PHARMA~50MG~A~090912~002~AB~Jul 27, 2011~N
o~RX~STRIDES PHARMA GLOBAL PTE LTD
ACARBOSE~TABLET;ORAL~ACARBOSE~STRIDES PHARMA~100MG~A~090912~003~AB~Jul 27, 2011~
No~RX~STRIDES PHARMA GLOBAL PTE LTD
ACARBOSE~TABLET;ORAL~ACARBOSE~VIRTUS PHARM~25MG~A~091343~001~AB~Oct 17, 2013~No~
RX~VIRTUS PHARMACEUTICAL INC
ACARBOSE~TABLET;ORAL~ACARBOSE~VIRTUS PHARM~50MG~A~091343~002~AB~Oct 17, 2013~No~
RX~VIRTUS PHARMACEUTICAL INC
ACARBOSE~TABLET;ORAL~ACARBOSE~VIRTUS PHARM~100MG~A~091343~003~AB~Oct 17, 2013~No
~RX~VIRTUS PHARMACEUTICAL INC
ACARBOSE~TABLET;ORAL~ACARBOSE~WATSON LABS~25MG~A~077532~001~AB~May 7, 2008~No~RX
~WATSON LABORATORIES INC
ACARBOSE~TABLET;ORAL~ACARBOSE~WATSON LABS~50MG~A~077532~002~AB~May 7, 2008~No~RX
ACARBOSE~TABLET;ORAL~ACARBOSE~WATSON LABS~100MG~A~077532~003~AB~May 7, 2008~No~R
ZAFIRLUKAST~TABLET;ORAL~ACCOLATE~PAR PHARM INC~10MG~N~020547~003~AB~Sep 17, 1999
~No~RX~PAR PHARMACEUTICAL INC
ZAFIRLUKAST~TABLET;ORAL~ACCOLATE~PAR PHARM INC~20MG~N~020547~001~AB~Sep 26, 1996
~Yes~RX~PAR PHARMACEUTICAL INC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~ACCUPRIL~PFIZER PHARMS~EQ 5MG BASE~N~019885~
001~AB~Nov 19, 1991~No~RX~PFIZER PHARMACEUTICALS LTD
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~ACCUPRIL~PFIZER PHARMS~EQ 10MG BASE~N~019885
~002~AB~Nov 19, 1991~No~RX~PFIZER PHARMACEUTICALS LTD
~003~AB~Nov 19, 1991~No~RX~PFIZER PHARMACEUTICALS LTD
~004~AB~Nov 19, 1991~Yes~RX~PFIZER PHARMACEUTICALS LTD
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~ACCURETIC~PFIZER PHARMS
~12.5MG;EQ 10MG BASE~N~020125~001~AB~Dec 28, 1999~No~RX~PFIZER PHARMACEUTICALS L
TD
~12.5MG;EQ 20MG BASE~N~020125~002~AB~Dec 28, 1999~No~RX~PFIZER PHARMACEUTICALS L
TD
~25MG;EQ 20MG BASE~N~020125~003~AB~Dec 28, 1999~Yes~RX~PFIZER PHARMACEUTICALS LT
D
PERINDOPRIL ERBUMINE~TABLET;ORAL~ACEON~SYMPLMED PHARMS LLC~2MG~N~020184~001~AB~D
ec 30, 1993~No~RX~SYMPLMED PHARMACEUTICALS LLC
ec 30, 1993~No~RX~SYMPLMED PHARMACEUTICALS LLC
ec 30, 1993~Yes~RX~SYMPLMED PHARMACEUTICALS LLC
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~ACETAMINOPHEN AND CODEINE PHOSPHATE
~ABLE~300MG;30MG~A~040452~001~~Aug 1, 2002~No~DISCN~ABLE LABORATORIES INC
~ABLE~300MG;60MG~A~040459~001~~Aug 1, 2002~No~DISCN~ABLE LABORATORIES INC
~AM THERAP~300MG;15MG~A~089478~001~~Mar 3, 1987~No~DISCN~AMERICAN THERAPEUTICS I
NC
NC
NC

NC
NC
NC
~AMNEAL PHARMS NY~300MG;30MG~A~040779~001~AA~May 29, 2008~No~RX~AMNEAL PHARMACEU
TICALS NY LLC
~AUROLIFE PHARMA LLC~300MG;15MG~A~202800~001~AA~Apr 15, 2013~No~RX~AUROLIFE PHAR
MA LLC
MA LLC
MA LLC
~DURAMED PHARMS BARR~300MG;15MG~A~040223~001~~Nov 18, 1997~No~DISCN~DURAMED PHAR
MACEUTICALS INC SUB BARR LABORATORIES INC
~DURAMED PHARMS BARR~300MG;15MG~A~088353~001~~Feb 6, 1984~No~DISCN~DURAMED PHARM
ACEUTICALS INC SUB BARR LABORATORIES INC
~EVERYLIFE~325MG;30MG~A~085217~001~~Approved Prior to Jan 1, 1982~No~DISCN~EVERY
LIFE
~HALSEY~300MG;15MG~A~083871~001~~Approved Prior to Jan 1, 1982~No~DISCN~HALSEY D
RUG CO INC
RUG CO INC
RUG CO INC
~KV PHARM~300MG;30MG~A~085288~001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHA
RMACEUTICAL CO
RMACEUTICAL CO
RMACEUTICAL CO

~KV PHARM~325MG;45MG **Federal Register determination that product was not disco
ntinued or withdrawn for safety or efficacy reasons**~A~085363~001~~Approved Pri
~LEDERLE~300MG;30MG~A~087141~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE
LABORATORIES DIV AMERICAN CYANAMID CO
~MALLINCKRODT INC~300MG;15MG~A~040419~001~AA~May 31, 2001~Yes~RX~MALLINCKRODT IN
C
~MALLINCKRODT INC~300MG;30MG~A~040419~002~AA~May 31, 2001~No~RX~MALLINCKRODT INC
~MALLINCKRODT INC~300MG;60MG~A~040419~003~AA~May 31, 2001~No~RX~MALLINCKRODT INC
~MIKART~300MG;30MG~A~089238~001~~Feb 25, 1986~No~DISCN~MIKART INC
~MIKART~300MG;60MG~A~089244~001~~Feb 25, 1986~No~DISCN~MIKART INC
~MIKART~650MG;30MG~A~089231~001~~Mar 3, 1986~No~DISCN~MIKART INC
~MIKART~650MG;60MG~A~089363~001~~Sep 9, 1991~No~DISCN~MIKART INC
~MUTUAL PHARM~300MG;15MG~A~085795~001~~Approved Prior to Jan 1, 1982~No~DISCN~MU
TUAL PHARMACEUTICAL CO INC
~MUTUAL PHARM~300MG;15MG~A~089671~001~~Feb 10, 1988~No~DISCN~MUTUAL PHARMACEUTIC
AL CO INC
~MUTUAL PHARM~300MG;30MG~A~085794~001~~Approved Prior to Jan 1, 1982~No~DISCN~MU
TUAL PHARMACEUTICAL CO INC
AL CO INC
~MUTUAL PHARM~300MG;60MG~A~087653~001~~Apr 13, 1982~No~DISCN~MUTUAL PHARMACEUTIC
AL CO INC
AL CO INC
~PURACAP PHARM~300MG;30MG~A~087762~001~~Dec 10, 1982~No~DISCN~PURACAP PHARMACEUT
ICAL LLC
~PUREPAC PHARM~300MG;30MG~A~086681~001~~Approved Prior to Jan 1, 1982~No~DISCN~P
UREPAC PHARMACEUTICAL CO
~PUREPAC PHARM~300MG;30MG~A~089080~001~~Jul 17, 1986~No~DISCN~PUREPAC PHARMACEUT
ICAL CO
~PUREPAC PHARM~300MG;60MG~A~086683~001~~Approved Prior to Jan 1, 1982~No~DISCN~P
UREPAC PHARMACEUTICAL CO
~RANBAXY~300MG;30MG~A~085868~001~AA~Approved Prior to Jan 1, 1982~No~RX~RANBAXY
PHARMACEUTICALS INC
~RANBAXY~300MG;60MG~A~087083~001~AA~Approved Prior to Jan 1, 1982~No~RX~RANBAXY
PHARMACEUTICALS INC
~ROXANE~300MG;15MG~A~084659~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE L
ABORATORIES INC
ABORATORIES INC
ABORATORIES INC
~ROXANE~500MG;15MG~A~089511~001~~Apr 25, 1989~No~DISCN~ROXANE LABORATORIES INC
~SANDOZ~300MG;15MG~A~087433~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ I
NC
~SANDOZ~300MG;30MG~A~081250~001~~Jul 16, 1992~No~DISCN~SANDOZ INC
NC
NC
~SANDOZ~300MG;60MG~A~081249~001~~Jul 16, 1992~No~DISCN~SANDOZ INC
NC
NC
~SUPERPHARM~300MG;15MG~A~089183~001~~Oct 18, 1985~No~DISCN~SUPERPHARM CORP
~SUPERPHARM~300MG;30MG~A~089253~001~~May 19, 1986~No~DISCN~SUPERPHARM CORP
~SUPERPHARM~300MG;60MG~A~089254~001~~May 19, 1986~No~DISCN~SUPERPHARM CORP
~TEVA~300MG;15MG~A~088627~001~AA~Mar 6, 1985~No~RX~TEVA PHARMACEUTICALS USA INC
~TEVA~300MG;30MG~A~088628~001~AA~Mar 6, 1985~No~RX~TEVA PHARMACEUTICALS USA INC
~TEVA~300MG;60MG~A~088629~001~AA~Mar 6, 1985~Yes~RX~TEVA PHARMACEUTICALS USA INC
~USL PHARMA~300MG;30MG~A~087919~001~~Jun 22, 1982~No~DISCN~USL PHARMA INC
~USL PHARMA~300MG;60MG~A~087920~001~~Jun 22, 1982~No~DISCN~USL PHARMA INC
~VALEANT PHARM INTL~300MG;30MG~A~085896~001~~Approved Prior to Jan 1, 1982~No~DI
SCN~VALEANT PHARMACEUTICALS INTERNATIONAL
~VINTAGE~300MG;15MG~A~089990~001~AA~Sep 30, 1988~No~RX~VINTAGE PHARMACEUTICALS L
LC
~VINTAGE~300MG;30MG~A~089805~001~AA~Sep 30, 1988~No~RX~VINTAGE PHARMACEUTICALS L
LC
~VINTAGE PHARMS~300MG;60MG~A~089828~001~AA~Sep 30, 1988~No~RX~VINTAGE PHARMACEUT
ICALS INC
~VITARINE~300MG;30MG~A~085676~001~~Approved Prior to Jan 1, 1982~No~DISCN~VITARI
NE PHARMACEUTICALS INC
~WARNER CHILCOTT~300MG;15MG~A~085992~001~~Approved Prior to Jan 1, 1982~No~DISCN
~WARNER CHILCOTT DIV WARNER LAMBERT CO
~WATSON LABS~300MG;15MG~A~087277~001~~May 26, 1982~No~DISCN~WATSON LABORATORIES
INC
~WATSON LABS~300MG;15MG~A~089997~001~~Dec 28, 1994~No~DISCN~WATSON LABORATORIES
INC
INC
INC
INC
INC
~WATSON LABS FLORIDA~300MG;15MG~A~040443~001~~Jan 22, 2003~No~DISCN~WATSON LABOR
ATORIES INC FLORIDA
ATORIES INC FLORIDA
ATORIES INC FLORIDA
~WHITEWORTH TOWN PLSN~300MG;30MG~A~084360~001~~Approved Prior to Jan 1, 1982~No~
DISCN~WHITEWORTH TOWNE PAULSEN INC
~WHITEWORTH TOWN PLSN~300MG;60MG~A~085607~001~~Approved Prior to Jan 1, 1982~No~
DISCN~WHITEWORTH TOWNE PAULSEN INC
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE~TABLET;ORAL~ACETAMINOPHEN AND PENTAZOCI
NE HYDROCHLORIDE~GAVIS PHARMS~650MG;EQ 25MG BASE~A~076202~001~~Aug 2, 2002~No~DI
SCN~GAVIS PHARMACEUTICALS LLC
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE~TABLET;ORAL~ACETAMINOPHEN AND PENTAZOCI
NE HYDROCHLORIDE~WATSON LABS~650MG;EQ 25MG BASE~A~074699~001~~Mar 24, 2000~No~DI
SCN~WATSON LABORATORIES
ACETAMINOPHEN; ASPIRIN; CAFFEINE~TABLET;ORAL~ACETAMINOPHEN, ASPIRIN AND CAFFEINE
~PERRIGO~250MG;250MG;65MG~A~075794~001~~Nov 26, 2001~No~OTC~L PERRIGO CO
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE~TABLET;ORAL~ACETAMINOPHEN, CA
FFEINE, AND DIHYDROCODEINE BITARTRATE~BOCA PHARMA LLC~712.8MG;60MG;32MG~A~040701
~001~~Apr 3, 2007~No~DISCN~BOCA PHARMACAL LLC

FFEINE, AND DIHYDROCODEINE BITARTRATE~MIKART~712.8MG;60MG;32MG~A~040316~001~~Apr
28, 1999~No~DISCN~MIKART INC
FFEINE, AND DIHYDROCODEINE BITARTRATE~WEST-WARD PHARM CORP~712.8MG;60MG;32MG~A~0
40637~001~~Sep 22, 2006~No~DISCN~WEST-WARD PHARMACEUTICAL CORP
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~ALRA~250MG~A~083320~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~ASCOT~250MG~A~087686~001~~Oct 20, 1982~N
o~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~LANNETT~250MG~A~084840~001~AB~Approved P
rior to Jan 1, 1982~No~RX~LANNETT CO INC
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~MUTUAL PHARM~125MG~A~089752~001~AB~Jun 2
2, 1988~No~RX~MUTUAL PHARMACEUTICAL CO INC
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~MUTUAL PHARM~250MG~A~089753~001~~Jun 22,
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~TARO~125MG~A~040195~001~AB~May 28, 1997~
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~TARO~250MG~A~040195~002~AB~May 28, 1997~
Yes~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~VANGARD~250MG~A~087654~001~~Feb 5, 1982~
No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~WATSON LABS~250MG~A~084498~002~~Approved
ACETAZOLAMIDE~TABLET;ORAL~ACETAZOLAMIDE~WATSON LABS~250MG~A~088882~001~~Oct 22,
ACETOHEXAMIDE~TABLET;ORAL~ACETOHEXAMIDE~BARR~250MG~A~070869~001~~Feb 9, 1987~No~
DISCN~BARR LABORATORIES INC
ACETOHEXAMIDE~TABLET;ORAL~ACETOHEXAMIDE~BARR~500MG~A~070870~001~~Feb 9, 1987~No~
ACETOHEXAMIDE~TABLET;ORAL~ACETOHEXAMIDE~USL PHARMA~250MG~A~070753~001~~Nov 3, 19
ACETOHEXAMIDE~TABLET;ORAL~ACETOHEXAMIDE~USL PHARMA~500MG~A~070754~001~~Nov 3, 19
ACETOHEXAMIDE~TABLET;ORAL~ACETOHEXAMIDE~WATSON LABS~250MG~A~071893~001~~Nov 25,
ACETOHEXAMIDE~TABLET;ORAL~ACETOHEXAMIDE~WATSON LABS~500MG~A~071894~001~~Nov 25,
IBUPROFEN~TABLET;ORAL~ACHES-N-PAIN~LEDERLE~200MG~A~071065~001~~May 28, 1987~No~D
DOXYCYCLINE HYCLATE~TABLET;ORAL~ACTICLATE~AQUA PHARMS LLC~EQ 75MG BASE~N~205931~
001~~Jul 25, 2014~No~RX~AQUA PHARMACEUTICALS LLC
DOXYCYCLINE HYCLATE~TABLET;ORAL~ACTICLATE~AQUA PHARMS LLC~EQ 150MG BASE~N~205931
~002~~Jul 25, 2014~Yes~RX~AQUA PHARMACEUTICALS LLC
TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~ACTIDIL~GLAXOSMITHKLINE~2.5MG~N~011110~00
ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~ACTIVELLA~AMNEAL PHARMS LLC~0.5MG;0
.1MG~N~020907~002~AB~Dec 28, 2006~No~RX~AMNEAL PHARMACEUTICALS LLC
ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~ACTIVELLA~AMNEAL PHARMS LLC~1MG;0.5
MG~N~020907~001~AB~Nov 18, 1998~Yes~RX~AMNEAL PHARMACEUTICALS LLC
RISEDRONATE SODIUM~TABLET;ORAL~ACTONEL~WARNER CHILCOTT LLC~5MG~N~020835~002~AB~A
pr 14, 2000~No~RX~WARNER CHILCOTT CO LLC
RISEDRONATE SODIUM~TABLET;ORAL~ACTONEL~WARNER CHILCOTT LLC~30MG~N~020835~001~AB~
Mar 27, 1998~No~RX~WARNER CHILCOTT CO LLC
RISEDRONATE SODIUM~TABLET;ORAL~ACTONEL~WARNER CHILCOTT LLC~35MG~N~020835~003~AB~
May 25, 2002~Yes~RX~WARNER CHILCOTT CO LLC
RISEDRONATE SODIUM~TABLET;ORAL~ACTONEL~WARNER CHILCOTT LLC~75MG **Federal Regist
ficacy reasons**~N~020835~004~~Apr 16, 2007~No~DISCN~WARNER CHILCOTT CO LLC
RISEDRONATE SODIUM~TABLET;ORAL~ACTONEL~WARNER CHILCOTT LLC~150MG~N~020835~005~AB
~Apr 22, 2008~Yes~RX~WARNER CHILCOTT CO LLC

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~ACTOPLUS MET~TAK
EDA PHARMS USA~500MG;EQ 15MG BASE~N~021842~001~AB~Aug 29, 2005~No~RX~TAKEDA PHAR
MACEUTICALS USA INC
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~ACTOPLUS MET~TAK
EDA PHARMS USA~850MG;EQ 15MG BASE~N~021842~002~AB~Aug 29, 2005~Yes~RX~TAKEDA PHA
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~ACTOS~TAKEDA PHARMS USA~EQ 15MG BASE~N~02
1073~001~AB~Jul 15, 1999~No~RX~TAKEDA PHARMACEUTICALS USA INC
1073~002~AB~Jul 15, 1999~No~RX~TAKEDA PHARMACEUTICALS USA INC
1073~003~AB~Jul 15, 1999~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
KETOPROFEN~TABLET;ORAL~ACTRON~BAYER~12.5MG~N~020499~001~~Oct 6, 1995~No~DISCN~BA
YER HEALTHCARE LLC
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~ACTAVIS ELIZABETH~400MG~A~074870~001~~Jun 5, 199
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~ACTAVIS ELIZABETH~800MG~A~074870~002~~Jun 5, 199
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~APOTEX INC~400MG~A~077309~001~AB~Sep 29, 2005~No
~RX~APOTEX INC ETOBICOKE SITE
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~APOTEX INC~800MG~A~077309~002~AB~Sep 29, 2005~No
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~CADILA PHARMS LTD~400MG~A~202168~001~AB~Nov 15,
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~CADILA PHARMS LTD~800MG~A~202168~002~AB~Nov 15,
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~CARLSBAD~400MG~A~075382~001~AB~Apr 30, 1999~No~R
X~CARLSBAD TECHNOLOGY INC
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~CARLSBAD~800MG~A~075382~002~AB~Apr 30, 1999~No~R
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~DAVA PHARMS INC~400MG~A~074834~001~~Apr 24, 1997
~No~DISCN~DAVA PHARMACEUTICALS INC
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~DAVA PHARMS INC~400MG~A~074946~001~AB~Nov 19, 19
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~DAVA PHARMS INC~800MG~A~074834~002~~Apr 24, 1997
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~DAVA PHARMS INC~800MG~A~074946~002~AB~Nov 19, 19
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~HERITAGE PHARMS INC~400MG~A~074891~001~~Oct 31,
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~HERITAGE PHARMS INC~800MG~A~074891~002~~Oct 31,
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~HETERO LABS LTD V~400MG~A~203834~001~AB~Oct 29,
2013~No~RX~HETERO LABS LTD UNIT V
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~HETERO LABS LTD V~800MG~A~203834~002~AB~Oct 29,
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~IVAX SUB TEVA PHARMS~400MG~A~074836~001~~Apr 22,
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~IVAX SUB TEVA PHARMS~800MG~A~074836~002~~Apr 22,
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~LEK PHARM~400MG~A~074658~001~~Apr 22, 1997~No~DI
SCN~LEK PHARMACEUTICAL AND CHEMICAL CO DD
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~LEK PHARM~800MG~A~074658~002~~Apr 22, 1997~No~DI
SCN~LEK PHARMACEUTICAL AND CHEMICAL CO DD
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~MYLAN~400MG~A~074976~001~~Apr 13, 1998~No~DISCN~
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~MYLAN~400MG~A~075211~001~AB~Sep 28, 1998~No~RX~M
YLAN LABORATORIES INC
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~MYLAN~800MG~A~074976~002~~Apr 13, 1998~No~DISCN~

ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~MYLAN~800MG~A~075211~002~AB~Sep 28, 1998~No~RX~M
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~RANBAXY~400MG~A~074980~001~AB~Sep 30, 1998~No~RX
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~RANBAXY~800MG~A~074980~002~AB~Sep 30, 1998~No~RX
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~TEVA~200MG **Federal Register determination that
product was not discontinued or withdrawn for safety or efficacy reasons**~A~07
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~TEVA~400MG~A~074556~002~AB~Apr 22, 1997~No~RX~TE
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~TEVA~800MG~A~074556~003~AB~Apr 22, 1997~No~RX~TE
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~TEVA PHARMS~400MG~A~075021~001~~Mar 18, 1998~No~
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~TEVA PHARMS~800MG~A~075021~002~~Mar 18, 1998~No~
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~ZYDUS PHARMS USA INC~400MG~A~204314~001~AB~Aug 1
ACYCLOVIR~TABLET;ORAL~ACYCLOVIR~ZYDUS PHARMS USA INC~800MG~A~204314~002~AB~Aug 1
ACETYLDIGITOXIN~TABLET;ORAL~ACYLANID~NOVARTIS~0.1MG~N~009436~001~~Approved Prior
to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
TADALAFIL~TABLET;ORAL~ADCIRCA~ELI LILLY CO~20MG~N~022332~001~~May 22, 2009~Yes~R
X~ELI LILLY CO
AMPHETAMINE SULFATE~TABLET;ORAL~ADDERALL 10~TEVA WOMENS~2.5MG;2.5MG;2.5MG;2.5MG~
N~011522~007~~Feb 13, 1996~No~DISCN~TEVA WOMENS HEALTH INC
AMPHETAMINE SULFATE~TABLET;ORAL~ADDERALL 12.5~TEVA WOMENS~3.125MG;3.125MG;3.125M
G;3.125MG~N~011522~012~~Aug 31, 2000~No~DISCN~TEVA WOMENS HEALTH INC
AMPHETAMINE SULFATE~TABLET;ORAL~ADDERALL 15~TEVA WOMENS~3.75MG;3.75MG;3.75MG;3.7
5MG~N~011522~013~~Aug 31, 2000~No~DISCN~TEVA WOMENS HEALTH INC
AMPHETAMINE SULFATE~TABLET;ORAL~ADDERALL 20~TEVA WOMENS~5MG;5MG;5MG;5MG~N~011522
~008~~Feb 13, 1996~No~DISCN~TEVA WOMENS HEALTH INC
AMPHETAMINE SULFATE~TABLET;ORAL~ADDERALL 30~TEVA WOMENS~7.5MG;7.5MG;7.5MG;7.5MG~
N~011522~010~~May 12, 1997~No~DISCN~TEVA WOMENS HEALTH INC
AMPHETAMINE SULFATE~TABLET;ORAL~ADDERALL 5~TEVA WOMENS~1.25MG;1.25MG;1.25MG;1.25
MG~N~011522~009~~May 12, 1997~No~DISCN~TEVA WOMENS HEALTH INC
AMPHETAMINE SULFATE~TABLET;ORAL~ADDERALL 7.5~TEVA WOMENS~1.875MG;1.875MG;1.875MG
;1.875MG~N~011522~011~~Aug 31, 2000~No~DISCN~TEVA WOMENS HEALTH INC
ADEFOVIR DIPIVOXIL~TABLET;ORAL~ADEFOVIR DIPIVOXIL~SIGMAPHARM LABS LLC~10MG~A~202
051~001~AB~Aug 29, 2013~No~RX~SIGMAPHARM LABORATORIES LLC
RIOCIGUAT~TABLET;ORAL~ADEMPAS~BAYER HLTHCARE~0.5MG~N~204819~001~~Oct 8, 2013~No~
RX~BAYER HEALTHCARE PHARMACEUTICALS INC
RIOCIGUAT~TABLET;ORAL~ADEMPAS~BAYER HLTHCARE~1MG~N~204819~002~~Oct 8, 2013~No~RX
~BAYER HEALTHCARE PHARMACEUTICALS INC
RIOCIGUAT~TABLET;ORAL~ADEMPAS~BAYER HLTHCARE~1.5MG~N~204819~003~~Oct 8, 2013~No~
RIOCIGUAT~TABLET;ORAL~ADEMPAS~BAYER HLTHCARE~2MG~N~204819~004~~Oct 8, 2013~No~RX
~BAYER HEALTHCARE PHARMACEUTICALS INC
RIOCIGUAT~TABLET;ORAL~ADEMPAS~BAYER HLTHCARE~2.5MG~N~204819~005~~Oct 8, 2013~Yes
~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~ADIPEX-P~TEVA~37.5MG~A~085128~001~AA~Appro
ved Prior to Jan 1, 1982~Yes~RX~TEVA PHARMACEUTICALS USA INC

PHENDIMETRAZINE TARTRATE~TABLET;ORAL~ADPHEN~FERNDALE LABS~35MG~A~083655~001~~App
roved Prior to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
IBUPROFEN~TABLET;ORAL~ADVIL~PFIZER~200MG~N~018989~001~~May 18, 1984~No~OTC~PFIZE
R INC
IBUPROFEN SODIUM~TABLET;ORAL~ADVIL~PFIZER CONS HLTHCARE~EQ 200MG BASE~N~201803~0
01~~Jun 12, 2012~Yes~OTC~PFIZER CONSUMER HEALTHCARE
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE~TABLET;ORAL~ADV
IL ALLERGY AND CONGESTION RELIEF~PFIZER~4MG;200MG;10MG~N~022113~001~~Dec 21, 201
1~Yes~OTC~PFIZER INC
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET;ORAL~A
DVIL ALLERGY SINUS~PFIZER~2MG;200MG;30MG~N~021441~001~~Dec 19, 2002~Yes~OTC~PFIZ
ER INC
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET;ORAL~ADVIL COLD AND SINUS~PFIZER
~200MG;30MG~N~019771~001~~Sep 19, 1989~Yes~OTC~PFIZER INC
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE~TABLET;ORAL~ADVIL CONGESTION RELIEF~PFIZE
R~200MG;10MG~N~022565~001~~May 27, 2010~Yes~OTC~PFIZER INC
DIPHENHYDRAMINE CITRATE; IBUPROFEN~TABLET;ORAL~ADVIL PM~PFIZER~38MG;200MG~N~0213
94~001~~Dec 21, 2005~Yes~OTC~PFIZER INC
EVEROLIMUS~TABLET;ORAL~AFINITOR~NOVARTIS~2.5MG~N~022334~003~~Jul 9, 2010~No~RX~N
OVARTIS PHARMACEUTICALS CORP
EVEROLIMUS~TABLET;ORAL~AFINITOR~NOVARTIS~5MG~N~022334~001~~Mar 30, 2009~No~RX~NO
VARTIS PHARMACEUTICALS CORP
EVEROLIMUS~TABLET;ORAL~AFINITOR~NOVARTIS~7.5MG~N~022334~004~~Mar 30, 2012~No~RX~
EVEROLIMUS~TABLET;ORAL~AFINITOR~NOVARTIS~10MG~N~022334~002~~Mar 30, 2009~Yes~RX~
BIPERIDEN HYDROCHLORIDE~TABLET;ORAL~AKINETON~ABBVIE~2MG~N~012003~001~~Approved P
rior to Jan 1, 1982~Yes~RX~ABBVIE INC
ALBENDAZOLE~TABLET;ORAL~ALBENZA~AMEDRA PHARMS~200MG~N~020666~001~~Jun 11, 1996~Y
es~RX~AMEDRA PHARMACEUTICALS LLC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~AM THERAP~EQ 2MG BASE~A~072449~0
01~~Dec 5, 1989~No~DISCN~AMERICAN THERAPEUTICS INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~AM THERAP~EQ 4MG BASE~A~072450~0
01~~Dec 5, 1989~No~DISCN~AMERICAN THERAPEUTICS INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~COPLEY PHARM~EQ 2MG BASE~A~07296
6~001~~Nov 22, 1991~No~DISCN~COPLEY PHARMACEUTICAL INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~COPLEY PHARM~EQ 4MG BASE~A~07296
7~001~~Nov 22, 1991~No~DISCN~COPLEY PHARMACEUTICAL INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~DAVA PHARMS INC~EQ 2MG BASE~A~07
2859~001~~Dec 20, 1989~No~DISCN~DAVA PHARMACEUTICALS INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~DAVA PHARMS INC~EQ 4MG BASE~A~07
2860~001~~Dec 20, 1989~No~DISCN~DAVA PHARMACEUTICALS INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~MUTUAL PHARM~EQ 2MG BASE~A~07263
7~002~AB~Dec 5, 1989~No~RX~MUTUAL PHARMACEUTICAL CO INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~MUTUAL PHARM~EQ 4MG BASE~A~07263
7~001~AB~Dec 5, 1989~No~RX~MUTUAL PHARMACEUTICAL CO INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~MYLAN~EQ 2MG BASE~A~072894~002~A
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~MYLAN~EQ 4MG BASE~A~072894~001~A
B~Jan 17, 1991~Yes~RX~MYLAN PHARMACEUTICALS INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~PLIVA~EQ 2MG BASE~A~072316~001~~
Dec 5, 1989~No~DISCN~PLIVA INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~PLIVA~EQ 4MG BASE~A~072317~001~~
Dec 5, 1989~No~DISCN~PLIVA INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~SANDOZ~EQ 2MG BASE~A~072151~001~
~Dec 5, 1989~No~DISCN~SANDOZ INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~SANDOZ~EQ 4MG BASE~A~072152~001~
~Dec 5, 1989~No~DISCN~SANDOZ INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~TEVA~EQ 2MG BASE~A~072619~001~~D
ec 5, 1989~No~DISCN~TEVA PHARMACEUTICALS USA INC

ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~TEVA~EQ 2MG BASE~A~072779~001~~J
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~TEVA~EQ 2MG BASE~A~072938~001~~M
ar 30, 1990~No~DISCN~TEVA PHARMACEUTICALS USA INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~TEVA~EQ 4MG BASE~A~072620~001~~D
ec 5, 1989~No~DISCN~TEVA PHARMACEUTICALS USA INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~TEVA~EQ 4MG BASE~A~072780~001~~J
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~TEVA~EQ 4MG BASE~A~072939~001~~M
ar 30, 1990~No~DISCN~TEVA PHARMACEUTICALS USA INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~UCB INC~EQ 2MG BASE~A~073120~001
~~Sep 29, 1992~No~DISCN~UCB INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~UCB INC~EQ 4MG BASE~A~073121~001
~~Sep 29, 1992~No~DISCN~UCB INC
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~WARNER CHILCOTT~EQ 2MG BASE~A~07
2817~001~~Jan 9, 1990~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~WARNER CHILCOTT~EQ 4MG BASE~A~07
2818~001~~Jan 9, 1990~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
ALBUTEROL SULFATE~TABLET;ORAL~ALBUTEROL SULFATE~WATSON LABS~EQ 2MG BASE~A~072629
~001~~Jan 31, 1991~No~DISCN~WATSON LABORATORIES INC
~001~~Aug 28, 1991~No~DISCN~WATSON LABORATORIES INC
~001~~Jan 31, 1991~No~DISCN~WATSON LABORATORIES INC
~001~~Aug 28, 1991~No~DISCN~WATSON LABORATORIES INC
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE~TABLET;ORAL~ALDACTAZIDE~GD SEARLE LLC~25MG;2
5MG~N~012616~004~AB~Dec 30, 1982~No~RX~GD SEARLE LLC
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE~TABLET;ORAL~ALDACTAZIDE~GD SEARLE LLC~50MG;5
0MG~N~012616~005~~Dec 30, 1982~Yes~RX~GD SEARLE LLC
SPIRONOLACTONE~TABLET;ORAL~ALDACTONE~GD SEARLE LLC~25MG~N~012151~009~AB~Dec 30,
1983~No~RX~GD SEARLE LLC
1982~No~RX~GD SEARLE LLC
1983~Yes~RX~GD SEARLE LLC
CHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~ALDOCLOR-150~MERCK~150MG;250MG~N~016016~0
CHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~ALDOCLOR-250~MERCK~250MG;250MG~N~016016~0
METHYLDOPA~TABLET;ORAL~ALDOMET~MERCK~125MG~N~013400~003~~Approved Prior to Jan 1
, 1982~No~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~ALDORIL 15~MERCK~15MG;250MG~N~013402
~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~ALDORIL 25~MERCK~25MG;250MG~N~013402
~002~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~ALDORIL D30~MERCK~30MG;500MG~N~01340
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~ALDORIL D50~MERCK~50MG;500MG~N~01340
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~APOTEX~EQ 5MG BASE~A~077982~00
1~AB~Aug 4, 2008~No~RX~APOTEX INC

ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~AUROBINDO PHARMA~EQ 10MG BASE~
A~090124~001~AB~Aug 4, 2008~No~RX~AUROBINDO PHARMA LTD
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~AUSTARPHARMA LLC~EQ 5MG BASE~A
~090258~001~AB~Sep 24, 2009~No~RX~AUSTARPHARMA LLC
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~AUSTARPHARMA LLC~EQ 10MG BASE~
A~090258~002~AB~Sep 24, 2009~No~RX~AUSTARPHARMA LLC
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~CADISTA PHARMS~EQ 5MG BASE~A~0
90557~001~AB~Feb 18, 2010~No~RX~CADISTA PHARMACEUTICALS INC
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~CADISTA PHARMS~EQ 10MG BASE~A~
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~CIPLA LTD~EQ 5MG BASE~A~076768
~001~AB~Aug 4, 2008~No~RX~CIPLA LTD
8~002~AB~Aug 4, 2008~No~RX~CIPLA LTD
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~DR REDDYS LABS LTD~EQ 5MG BASE
~A~079109~001~AB~Aug 4, 2008~No~RX~DR REDDYS LABORATORIES LTD
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~DR REDDYS LABS LTD~EQ 10MG BAS
E~A~079109~002~AB~Aug 4, 2008~No~RX~DR REDDYS LABORATORIES LTD
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~MYLAN~EQ 5MG BASE~A~076584~001
~AB~Aug 4, 2008~No~RX~MYLAN PHARMACEUTICALS INC
2~AB~Aug 4, 2008~No~RX~MYLAN PHARMACEUTICALS INC
1~~Aug 4, 2008~No~DISCN~MYLAN PHARMACEUTICALS INC
2~~Aug 4, 2008~No~DISCN~MYLAN PHARMACEUTICALS INC
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~SANDOZ~EQ 5MG BASE~A~075871~00
1~~Apr 22, 2009~No~DISCN~SANDOZ INC

ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~SUN PHARMA GLOBAL~EQ 5MG BASE~
A~090022~001~AB~Sep 10, 2008~No~RX~SUN PHARMA GLOBAL FZE
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~SUN PHARMA GLOBAL~EQ 10MG BASE
~A~090022~002~AB~Sep 10, 2008~No~RX~SUN PHARMA GLOBAL FZE
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~TEVA PHARMS~EQ 5MG BASE~A~0757
10~001~AB~Feb 6, 2008~No~RX~TEVA PHARMACEUTICALS USA
184~002~~Aug 4, 2008~No~DISCN~TEVA PHARMACEUTICALS USA
184~001~~Feb 6, 2008~No~DISCN~TEVA PHARMACEUTICALS USA
ALENDRONATE SODIUM~TABLET;ORAL~ALENDRONATE SODIUM~WATSON LABS~EQ 35MG BASE~A~076
NAPROXEN SODIUM~TABLET;ORAL~ALEVE~BAYER~EQ 200MG BASE~N~020204~002~~Jan 11, 1994
~Yes~OTC~BAYER HEALTHCARE LLC
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM~TABLET;ORAL~ALEVE PM~BAYER HLTHCA
RE~25MG;220MG~N~205352~001~~Jan 17, 2014~Yes~OTC~BAYER HEALTHCARE CONSUMER CARE
NITAZOXANIDE~TABLET;ORAL~ALINIA~ROMARK~500MG~N~021497~001~~Jul 21, 2004~Yes~RX~R
OMARK LABORATORIES
MELPHALAN~TABLET;ORAL~ALKERAN~GLAXOSMITHKLINE~2MG~N~014691~002~~Approved Prior t
o Jan 1, 1982~Yes~RX~GLAXOSMITHKLINE
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~ALLEGRA ALLERGY~SANOFI AVENTIS US~60MG~N~
020872~007~~Jan 24, 2011~No~OTC~SANOFI AVENTIS US LLC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~ALLEGRA ALLERGY~SANOFI AVENTIS US~180MG~N
~020872~010~~Jan 24, 2011~Yes~OTC~SANOFI AVENTIS US LLC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~ALLEGRA HIVES~SANOFI AVENTIS US~60MG~N~02
0872~008~~Jan 24, 2011~No~OTC~SANOFI AVENTIS US LLC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~ALLEGRA HIVES~SANOFI AVENTIS US~180MG~N~0
20872~009~~Jan 24, 2011~Yes~OTC~SANOFI AVENTIS US LLC
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~ALLERFED~P
VT FORM~60MG;2.5MG~A~088860~001~~Jan 31, 1985~No~DISCN~PRIVATE FORMULATIONS INC
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~ACCORD HLTHCARE~100MG~A~203154~001~AB~May 6,
2013~No~RX~ACCORD HEALTHCARE INC
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~ACCORD HLTHCARE~300MG~A~203154~002~AB~May 6,
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~APOTEX INC~100MG~A~077353~001~AB~Sep 8, 2005
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~APOTEX INC~300MG~A~077353~002~AB~Sep 8, 2005
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~IPCA LABS LTD~100MG~A~090637~001~AB~Mar 16,
2011~No~RX~IPCA LABORATORIES LTD

ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~IPCA LABS LTD~300MG~A~090637~002~AB~Mar 16,
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~MUTUAL PHARM~100MG~A~070466~001~~Dec 24, 198
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~MUTUAL PHARM~100MG~A~071449~001~AB~Jan 9, 19
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~MUTUAL PHARM~300MG~A~070467~001~~Dec 24, 198
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~MUTUAL PHARM~300MG~A~071450~001~AB~Jan 9, 19
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~MYLAN~100MG~A~018659~001~AB~Oct 24, 1986~No~
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~MYLAN~300MG~A~018659~002~AB~Oct 24, 1986~No~
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~NORTHSTAR HLTHCARE~100MG~A~078253~001~AB~Sep
11, 2007~No~RX~NORTHSTAR HEALTHCARE HOLDINGS LTD
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~NORTHSTAR HLTHCARE~300MG~A~078253~002~AB~Sep
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~PURACAP PHARM~100MG~A~070150~001~~Dec 10, 19
85~No~DISCN~PURACAP PHARMACEUTICAL LLC
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~PURACAP PHARM~300MG~A~070147~001~~Dec 10, 19
85~No~DISCN~PURACAP PHARMACEUTICAL LLC
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~PUREPAC PHARM~100MG~A~070579~001~~Apr 14, 19
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~PUREPAC PHARM~300MG~A~070580~001~~Apr 14, 19
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~SANDOZ~100MG~A~070268~001~~Dec 31, 1985~No~D
ISCN~SANDOZ INC
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~SANDOZ~300MG~A~070269~001~~Dec 31, 1985~No~D
ISCN~SANDOZ INC
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~SUN PHARM INDS INC~100MG~A~078390~001~AB~Aug
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~SUN PHARM INDS INC~300MG~A~078390~002~AB~Aug
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~SUPERPHARM~100MG~A~070950~001~~Nov 30, 1988~
No~DISCN~SUPERPHARM CORP
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~SUPERPHARM~300MG~A~070951~001~~Nov 30, 1988~
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~VINTAGE PHARMS~100MG~A~075798~001~AB~Jun 27,
2003~No~RX~VINTAGE PHARMACEUTICALS INC
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~VINTAGE PHARMS~300MG~A~075798~002~AB~Jun 27,
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~WATSON LABS~100MG~N~018241~001~~Nov 16, 1984
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~WATSON LABS~100MG~N~018785~001~~Sep 28, 1984
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~WATSON LABS~100MG~N~018832~002~AB~Sep 28, 19
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~WATSON LABS~300MG~N~018241~002~~Nov 16, 1984
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~WATSON LABS~300MG~N~018785~002~~Sep 28, 1984
ALLOPURINOL~TABLET;ORAL~ALLOPURINOL~WATSON LABS~300MG~N~018877~001~AB~Sep 28, 19
FLUPREDNISOLONE~TABLET;ORAL~ALPHADROL~PHARMACIA AND UPJOHN~1.5MG~N~012259~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~ALPHAZINE~SANDOZ~35MG~A~085034~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~0.25MG~A~074342~001~AB~Oct 3

ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~0.5MG~A~074342~002~AB~Oct 31
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~1MG~A~074342~003~AB~Oct 31,
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~ACTAVIS ELIZABETH~2MG~A~074342~004~AB~Oct 31,
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~APOTEX INC~0.25MG~A~077741~001~AB~Jan 19, 2007
~No~RX~APOTEX INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~APOTEX INC~0.5MG~A~077741~002~AB~Jan 19, 2007~
No~RX~APOTEX INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~APOTEX INC~1MG~A~077741~003~AB~Jan 19, 2007~No
~RX~APOTEX INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~APOTEX INC~2MG~A~077741~004~AB~Jan 19, 2007~No
~RX~APOTEX INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~DAVA INTL INC~0.25MG~A~074174~001~AB~Oct 19, 1
993~No~RX~DAVA INTERNATIONAL INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~DAVA INTL INC~0.5MG~A~074174~002~AB~Oct 19, 19
93~No~RX~DAVA INTERNATIONAL INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~DAVA INTL INC~1MG~A~074174~003~AB~Oct 19, 1993
~No~RX~DAVA INTERNATIONAL INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~DAVA INTL INC~2MG~A~074174~004~AB~Oct 19, 1993
~No~RX~DAVA INTERNATIONAL INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~IVAX SUB TEVA PHARMS~0.25MG~A~074294~001~~Jul
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~IVAX SUB TEVA PHARMS~0.5MG~A~074294~002~~Jul 2
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~IVAX SUB TEVA PHARMS~1MG~A~074294~003~~Jul 29,
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~IVAX SUB TEVA PHARMS~2MG~A~074294~004~~Jul 29,
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~MYLAN~0.25MG~A~074215~001~AB~Jan 27, 1994~No~R
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~MYLAN~0.5MG~A~074215~002~AB~Jan 27, 1994~No~RX
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~MYLAN~1MG~A~074215~003~AB~Jan 27, 1994~No~RX~M
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~MYLAN~2MG~A~074215~004~AB~Jan 27, 1994~No~RX~M
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~MYLAN PHARMS INC~0.25MG~A~074046~001~AB~Oct 19
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~MYLAN PHARMS INC~0.5MG~A~074046~002~AB~Oct 19,
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~MYLAN PHARMS INC~1MG~A~074046~003~AB~Oct 19, 1
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~MYLAN PHARMS INC~2MG~A~074046~004~AB~May 7, 19
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~ROXANE~0.25MG~A~074199~001~~Oct 19, 1993~No~DI
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~ROXANE~0.5MG~A~074199~002~~Oct 19, 1993~No~DIS
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~ROXANE~1MG~A~074199~003~~Oct 19, 1993~No~DISCN
~ROXANE LABORATORIES INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~SANDOZ~0.25MG~A~074112~001~AB~Dec 29, 1995~No~
RX~SANDOZ INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~SANDOZ~0.5MG~A~074112~002~AB~Dec 29, 1995~No~R
X~SANDOZ INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~SANDOZ~1MG~A~074112~003~AB~Dec 29, 1995~No~RX~
SANDOZ INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~SANDOZ~2MG~A~074909~001~AB~Mar 25, 1998~No~RX~
SANDOZ INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~SUN PHARMA GLOBAL~0.25MG~A~090082~001~AB~Jun 1
7, 2010~No~RX~SUN PHARMA GLOBAL INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~SUN PHARMA GLOBAL~0.5MG~A~090082~002~AB~Jun 17
, 2010~No~RX~SUN PHARMA GLOBAL INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~SUN PHARMA GLOBAL~1MG~A~090082~003~AB~Jun 17,
2010~No~RX~SUN PHARMA GLOBAL INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~SUN PHARMA GLOBAL~2MG~A~090082~004~AB~Jun 17,
2010~No~RX~SUN PHARMA GLOBAL INC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~TEVA~0.25MG~A~074085~001~~Feb 16, 1994~No~DISC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~TEVA~0.5MG~A~074085~002~~Feb 16, 1994~No~DISCN
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~TEVA~1MG~A~074085~003~~Feb 16, 1994~No~DISCN~T
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~TEVA~2MG~A~074085~004~~Feb 26, 1996~No~DISCN~T
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~VINTAGE~0.25MG~A~078491~001~AB~Sep 25, 2008~No
~RX~VINTAGE PHARMACEUTICALS LLC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~VINTAGE~0.5MG~A~078491~002~AB~Sep 25, 2008~No~
RX~VINTAGE PHARMACEUTICALS LLC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~VINTAGE~1MG~A~078491~003~AB~Sep 25, 2008~No~RX
~VINTAGE PHARMACEUTICALS LLC
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~VINTAGE~2MG~A~078491~004~AB~Dec 12, 2008~No~RX
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~VINTAGE PHARMS~0.25MG~A~090248~001~AB~Sep 17,
2010~No~RX~VINTAGE PHARMACEUTICALS
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~VINTAGE PHARMS~0.5MG~A~090248~002~AB~Sep 17, 2
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~VINTAGE PHARMS~1MG~A~090248~003~AB~Sep 17, 201
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~VINTAGE PHARMS~2MG~A~090248~004~AB~Sep 17, 201
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~WATSON LABS~0.25MG~A~074456~001~~Aug 31, 1995~
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~WATSON LABS~0.25MG~A~074479~001~~Jan 21, 1997~
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~WATSON LABS~0.5MG~A~074456~002~~Aug 31, 1995~N
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~WATSON LABS~0.5MG~A~074479~002~~Jan 21, 1997~N
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~WATSON LABS~1MG~A~074456~003~~Aug 31, 1995~No~
ALPRAZOLAM~TABLET;ORAL~ALPRAZOLAM~WATSON LABS~1MG~A~074479~003~~Jan 21, 1997~No~
RAMIPRIL~TABLET;ORAL~ALTACE~KING PFIZER~1.25MG~N~022021~001~~Feb 27, 2007~No~DIS
CN~KING PHARMACEUTICALS INC SUB PFIZER INC
RAMIPRIL~TABLET;ORAL~ALTACE~KING PFIZER~2.5MG~N~022021~002~~Feb 27, 2007~No~DISC
N~KING PHARMACEUTICALS INC SUB PFIZER INC
RAMIPRIL~TABLET;ORAL~ALTACE~KING PFIZER~5MG~N~022021~003~~Feb 27, 2007~No~DISCN~
KING PHARMACEUTICALS INC SUB PFIZER INC
RAMIPRIL~TABLET;ORAL~ALTACE~KING PFIZER~10MG~N~022021~004~~Feb 27, 2007~No~DISCN
~KING PHARMACEUTICALS INC SUB PFIZER INC
METAPROTERENOL SULFATE~TABLET;ORAL~ALUPENT~BOEHRINGER INGELHEIM~10MG~N~015874~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTICALS I
NC
METAPROTERENOL SULFATE~TABLET;ORAL~ALUPENT~BOEHRINGER INGELHEIM~20MG~N~015874~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTICALS I
NC
AMANTADINE HYDROCHLORIDE~TABLET;ORAL~AMANTADINE HYDROCHLORIDE~USL PHARMA~100MG~A
~076186~001~~Dec 16, 2002~Yes~RX~USL PHARMA INC

GLIMEPIRIDE~TABLET;ORAL~AMARYL~SANOFI AVENTIS US~1MG~N~020496~001~AB~Nov 30, 199
5~Yes~RX~SANOFI AVENTIS US LLC
5~No~RX~SANOFI AVENTIS US LLC
ZOLPIDEM TARTRATE~TABLET;ORAL~AMBIEN~SANOFI AVENTIS US~5MG~N~019908~001~AB~Dec 1
6, 1992~No~RX~SANOFI AVENTIS US LLC
ZOLPIDEM TARTRATE~TABLET;ORAL~AMBIEN~SANOFI AVENTIS US~10MG~N~019908~002~AB~Dec
16, 1992~Yes~RX~SANOFI AVENTIS US LLC
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~AMEN~AMARIN PHARMS~10MG~A~083242~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~AMARIN PHARMACEUTICALS INC
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~AMERGE~GLAXOSMITHKLINE LLC~EQ 1MG BASE~N~0
20763~002~AB~Feb 10, 1998~No~RX~GLAXOSMITHKLINE LLC
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~AMERGE~GLAXOSMITHKLINE LLC~EQ 2.5MG BASE~N
~020763~001~AB~Feb 10, 1998~Yes~RX~GLAXOSMITHKLINE LLC
AMINOCAPROIC ACID~TABLET;ORAL~AMICAR~CLOVER PHARMS~1GM~N~015197~002~~Jun 24, 200
4~Yes~RX~CLOVER PHARMACEUTICALS CORP
AMINOCAPROIC ACID~TABLET;ORAL~AMICAR~CLOVER PHARMS~500MG~N~015197~001~AB~Approve
d Prior to Jan 1, 1982~No~RX~CLOVER PHARMACEUTICALS CORP
AMILORIDE HYDROCHLORIDE~TABLET;ORAL~AMILORIDE HYDROCHLORIDE~PAR PHARM~5MG~A~0703
46~001~AB~Jan 22, 1986~Yes~RX~PAR PHARMACEUTICAL INC
AMILORIDE HYDROCHLORIDE~TABLET;ORAL~AMILORIDE HYDROCHLORIDE~SIGMAPHARM LABS LLC~
5MG~A~079133~001~AB~Jan 30, 2009~No~RX~SIGMAPHARM LABORATORIES LLC
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~AMILORIDE HYDROCHLORIDE
AND HYDROCHLOROTHIAZIDE~BARR~EQ 5MG ANHYDROUS;50MG~A~071111~001~AB~May 10, 1988
~No~RX~BARR LABORATORIES INC
AND HYDROCHLOROTHIAZIDE~MYLAN~EQ 5MG ANHYDROUS;50MG~A~073209~001~AB~Oct 31, 199
AND HYDROCHLOROTHIAZIDE~SANDOZ~EQ 5MG ANHYDROUS;50MG~A~073357~001~~Nov 27, 1991
~No~DISCN~SANDOZ INC
AND HYDROCHLOROTHIAZIDE~TEVA~EQ 5MG ANHYDROUS;50MG~A~070795~001~~Apr 17, 1988~N
o~DISCN~TEVA PHARMACEUTICALS USA INC
AND HYDROCHLOROTHIAZIDE~WATSON LABS~EQ 5MG ANHYDROUS;50MG~A~073334~001~~Jul 19,
AMINOCAPROIC ACID~TABLET;ORAL~AMINOCAPROIC~MIKART~500MG~A~075602~001~AB~May 24,
2001~No~RX~MIKART INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLIN~GD SEARLE LLC~100MG~N~002386~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLIN~GD SEARLE LLC~200MG~N~002386~003~~Approve
d Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~ASCOT~100MG~A~087522~001~~Feb 12, 1982~N
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~ASCOT~200MG~A~087523~001~~Feb 12, 1982~N
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~BARR~100MG~A~088297~001~~Aug 19, 1983~No
~DISCN~BARR LABORATORIES INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~BARR~200MG~A~088298~001~~Aug 19, 1983~No
~DISCN~BARR LABORATORIES INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~DURAMED PHARMS BARR~100MG~A~088182~001~~
Mar 31, 1983~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~DURAMED PHARMS BARR~200MG~A~088183~001~~
Mar 31, 1983~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~HALSEY~100MG~A~084674~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~HIKMA INTL PHARMS~100MG~A~084540~001~~Ap

proved Prior to Jan 1, 1982~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~HIKMA INTL PHARMS~200MG~A~085003~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~IMPAX LABS~100MG~A~084574~001~~Approved
Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~IMPAX LABS~200MG~A~084576~001~~Approved
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~KV PHARM~100MG~A~085284~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~KV PHARM~200MG~A~085289~001~~Approved Pr
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~LANNETT~100MG~A~084588~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~LANNETT CO INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~LANNETT~200MG~A~084588~002~~Approved Pri
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~PAL PAK~100MG~A~084533~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~PAL PAK INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~PANRAY~100MG~A~084552~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~PANRAY~200MG~A~084552~002~~Approved Prio
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~PUREPAC PHARM~100MG~A~084699~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~PUREPAC PHARM~200MG~A~085333~001~~Approv
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~ROXANE~100MG~A~087500~001~~Feb 9, 1982~N
o~DISCN~ROXANE LABORATORIES INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~ROXANE~200MG~A~087501~001~~Feb 9, 1982~N
o~DISCN~ROXANE LABORATORIES INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~SANDOZ~100MG~A~085261~003~~Approved Prio
r to Jan 1, 1982~No~DISCN~SANDOZ INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~VALEANT PHARM INTL~200MG~A~084563~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~VANGARD~100MG~A~088314~001~~Oct 3, 1983~
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~VANGARD~200MG~A~088319~001~~Oct 3, 1983~
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~VINTAGE PHARMS~100MG~A~085409~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~VINTAGE PHARMACEUTICALS INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~VINTAGE PHARMS~200MG~A~085410~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~VINTAGE PHARMACEUTICALS INC
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~WATSON LABS~100MG~A~085567~001~~Approved
AMINOPHYLLINE~TABLET;ORAL~AMINOPHYLLINE~WATSON LABS~200MG~A~085564~001~~Approved
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~APOTEX CORP~200MG~
A~078578~001~AB~Nov 6, 2008~No~RX~APOTEX CORP
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~BARR~200MG~A~07538
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~MURTY PHARMS~200MG
~A~077069~001~AB~Apr 8, 2005~No~RX~MURTY PHARMACEUTICALS INC
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~MURTY PHARMS~400MG
~A~077069~002~AB~Apr 8, 2005~No~RX~MURTY PHARMACEUTICALS INC
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~MYLAN~200MG~A~0751
88~001~AB~Feb 24, 1999~No~RX~MYLAN PHARMACEUTICALS INC
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~SANDOZ~200MG~A~075

315~001~AB~Dec 23, 1998~No~RX~SANDOZ INC
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~SANDOZ~400MG~A~075
315~002~AB~Jun 30, 2000~No~RX~SANDOZ INC
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~TARO~100MG~A~07542
4~002~AB~Dec 18, 2002~No~RX~TARO PHARMACEUTICALS USA INC
4~001~AB~Mar 30, 2001~No~RX~TARO PHARMACEUTICALS USA INC
2~002~~Dec 2, 2003~No~RX~TARO PHARMACEUTICALS USA INC
2~001~AB~Nov 29, 2002~No~RX~TARO PHARMACEUTICALS USA INC
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~TEVA~200MG~A~07489
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~TEVA PHARMS~200MG~
A~074739~001~AB~Nov 30, 1998~No~RX~TEVA PHARMACEUTICALS USA
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~AMIODARONE HYDROCHLORIDE~ZYDUS PHARMS USA I
NC~200MG~A~079029~001~AB~Sep 16, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITID~BRISTOL MYERS SQUIBB~10MG~A~08645
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIL~WARNER CHILCOTT~10MG~A~083939~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~ACCORD HLTHC
ARE~10MG~A~202446~001~AB~Jun 4, 2014~No~RX~ACCORD HEALTHCARE INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~AM THERAP~25
MG~A~088672~001~~Nov 20, 1984~No~DISCN~AMERICAN THERAPEUTICS INC
0MG~A~088675~001~~Nov 20, 1984~No~DISCN~AMERICAN THERAPEUTICS INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~COPLEY PHARM

~10MG~A~088421~001~~Apr 30, 1984~No~DISCN~COPLEY PHARMACEUTICAL INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~HALSEY~10MG~
A~085923~001~~Approved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
A~087557~001~~Mar 5, 1982~No~DISCN~HALSEY DRUG CO INC
A~085926~001~~May 20, 1983~No~DISCN~HALSEY DRUG CO INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~HALSEY~100MG
~A~085927~001~~May 20, 1983~No~DISCN~HALSEY DRUG CO INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~LEDERLE~10MG
MERICAN CYANAMID CO
~A~087366~001~~Jan 4, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID C
O
MERICAN CYANAMID CO
~A~087367~001~~May 3, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID C
O
MERICAN CYANAMID CO
O
MERICAN CYANAMID CO
O
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~LEDERLE~100M
G~A~086747~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV
G~A~087368~001~~May 3, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID
CO
G~A~087370~001~~Jan 4, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID
CO
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~MUTUAL PHARM
~10MG~A~085744~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL
CO INC

~10MG~A~089399~002~AB~Jul 14, 1987~No~RX~MUTUAL PHARMACEUTICAL CO INC
CO INC
CO INC
CO INC
~100MG~A~085742~002~~May 11, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
~150MG~A~089423~001~~Feb 17, 1987~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~MYLAN~10MG~A
~086009~002~AB~Approved Prior to Jan 1, 1982~No~RX~MYLAN PHARMACEUTICALS INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~MYLAN~100MG~
A~086009~005~AB~Approved Prior to Jan 1, 1982~No~RX~MYLAN PHARMACEUTICALS INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~MYLAN~150MG~
A~086009~006~AB~Approved Prior to Jan 1, 1982~No~RX~MYLAN PHARMACEUTICALS INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~PAR PHARM~10
MG~A~088697~001~~Sep 25, 1984~No~DISCN~PAR PHARMACEUTICAL INC
0MG~A~088701~001~~Sep 25, 1984~No~DISCN~PAR PHARMACEUTICAL INC
0MG~A~088702~001~~Sep 25, 1984~No~DISCN~PAR PHARMACEUTICAL INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~PLIVA~10MG~A
~088883~001~~Sep 26, 1984~No~DISCN~PLIVA INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~PLIVA~100MG~
A~088887~001~~Sep 26, 1984~No~DISCN~PLIVA INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~PLIVA~150MG~
A~088888~001~~Sep 26, 1984~No~DISCN~PLIVA INC

AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~PUREPAC PHAR
M~10MG~A~088075~001~~Sep 16, 1983~No~DISCN~PUREPAC PHARMACEUTICAL CO
M~10MG~A~088084~001~~Jul 18, 1983~No~DISCN~PUREPAC PHARMACEUTICAL CO
M~25MG~A~088076~001~~May 20, 1983~No~DISCN~PUREPAC PHARMACEUTICAL CO
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~ROXANE~10MG~
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~ROXANE~100MG
~A~086003~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~SANDOZ~10MG~
A~085969~001~AB~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
A~085966~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~SANDOZ~100MG
~A~085967~001~AB~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~SANDOZ~150MG
~A~085970~001~AB~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~SUN PHARM IN
DS INC~10MG~A~040816~002~AB~Jun 27, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC

DS INC~100MG~A~040816~005~AB~Jun 27, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES IN
C
DS INC~150MG~A~040816~006~AB~Jun 27, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES IN
C
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~SUPERPHARM~1
0MG~A~088853~001~~Nov 13, 1984~No~DISCN~SUPERPHARM CORP
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~TEVA~10MG~A~
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~TEVA~100MG~A
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~UCB INC~10MG
~A~085864~001~~Approved Prior to Jan 1, 1982~No~DISCN~UCB INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~UCB INC~100M
G~A~086336~001~~Approved Prior to Jan 1, 1982~No~DISCN~UCB INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~UCB INC~150M
G~A~086335~001~~Approved Prior to Jan 1, 1982~No~DISCN~UCB INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~USL PHARMA~2
5MG~A~087775~001~~Feb 10, 1982~No~DISCN~USL PHARMA INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~VANGARD~10MG
~A~087632~001~~Feb 1, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL
CO

CO
CO
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~VANGARD~100M
G~A~087639~001~~Feb 8, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL
CO
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~VINTAGE PHAR
MS~10MG~A~040218~001~AB~Sep 11, 1997~No~RX~VINTAGE PHARMACEUTICALS INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~WATSON LABS~
C
10MG~A~088620~001~~Mar 2, 1984~No~DISCN~WATSON LABORATORIES INC
C
C
C
100MG~A~085820~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES I
NC
150MG~A~085821~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES I
NC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~WEST WARD~10
MG~A~087647~001~~Mar 5, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~AMITRIPTYLINE HYDROCHLORIDE~WEST WARD~25
MG~A~087278~001~~Approved Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL
CORP
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ACCORD HLTHCARE~EQ 2.5MG BAS
E~A~202553~001~AB~Apr 29, 2013~No~RX~ACCORD HEALTHCARE INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ACCORD HLTHCARE~EQ 5MG BASE~
A~202553~002~AB~Apr 29, 2013~No~RX~ACCORD HEALTHCARE INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ACCORD HLTHCARE~EQ 10MG BASE

~A~202553~003~AB~Apr 29, 2013~No~RX~ACCORD HEALTHCARE INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ALKEM~EQ 2.5MG BASE~A~078925
~001~AB~May 4, 2009~No~RX~ALKEM LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ALKEM~EQ 5MG BASE~A~078925~0
02~AB~May 4, 2009~No~RX~ALKEM LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ALKEM~EQ 10MG BASE~A~078925~
003~AB~May 4, 2009~No~RX~ALKEM LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~AMNEAL PHARMS NY~EQ 2.5MG BA
SE~A~078477~001~AB~Jan 16, 2008~No~RX~AMNEAL PHARMACEUTICALS NY LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~AMNEAL PHARMS NY~EQ 5MG BASE
~A~078477~002~AB~Jan 16, 2008~No~RX~AMNEAL PHARMACEUTICALS NY LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~AMNEAL PHARMS NY~EQ 10MG BAS
E~A~078477~003~AB~Jan 16, 2008~No~RX~AMNEAL PHARMACEUTICALS NY LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~APOTEX~EQ 2.5MG BASE~A~07671
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~APOTEX~EQ 5MG BASE~A~076719~
002~AB~May 23, 2007~No~RX~APOTEX INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~APOTEX~EQ 10MG BASE~A~076719
~003~AB~May 23, 2007~No~RX~APOTEX INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~AUROBINDO PHARMA~EQ 2.5MG BA
SE~A~078021~001~AB~Jul 17, 2007~No~RX~AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~AUROBINDO PHARMA~EQ 5MG BASE
~A~078021~002~AB~Jul 17, 2007~No~RX~AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~AUROBINDO PHARMA~EQ 10MG BAS
E~A~078021~003~AB~Jul 17, 2007~No~RX~AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~CIPLA LTD~EQ 2.5MG BASE~A~07
7073~001~AB~Sep 26, 2007~No~RX~CIPLA LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~CIPLA LTD~EQ 5MG BASE~A~0770
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~CIPLA LTD~EQ 10MG BASE~A~077
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~DR REDDYS LABS LTD~EQ 2.5MG
BASE~A~076692~001~AB~Jul 20, 2007~No~RX~DR REDDYS LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~DR REDDYS LABS LTD~EQ 5MG BA
SE~A~076692~002~AB~Jul 20, 2007~No~RX~DR REDDYS LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~DR REDDYS LABS LTD~EQ 10MG B
ASE~A~076692~003~AB~Jul 20, 2007~No~RX~DR REDDYS LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~EPIC PHARMA LLC~EQ 2.5MG BAS
E~A~078552~001~AB~Apr 8, 2009~No~RX~EPIC PHARMA LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~EPIC PHARMA LLC~EQ 5MG BASE~
A~078552~002~AB~Apr 8, 2009~No~RX~EPIC PHARMA LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~EPIC PHARMA LLC~EQ 10MG BASE
~A~078552~003~AB~Apr 8, 2009~No~RX~EPIC PHARMA LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~GEDEON RICHTER USA~EQ 2.5MG
BASE~A~077333~001~~Jul 17, 2007~No~DISCN~GEDEON RICHTER USA INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~GEDEON RICHTER USA~EQ 5MG BA
SE~A~077333~002~~Jul 17, 2007~No~DISCN~GEDEON RICHTER USA INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~GEDEON RICHTER USA~EQ 10MG B
ASE~A~077333~003~~Jul 17, 2007~No~DISCN~GEDEON RICHTER USA INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~GENPHARM~EQ 2.5MG BASE~A~077
362~001~~Jul 9, 2007~No~DISCN~GENPHARM INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~GENPHARM~EQ 5MG BASE~A~07736
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~GENPHARM~EQ 10MG BASE~A~0773
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~HIKMA PHARMS~EQ 2.5MG BASE~A
~077771~001~AB~Apr 12, 2011~No~RX~HIKMA PHARMACEUTICALS
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~HIKMA PHARMS~EQ 5MG BASE~A~0
77771~002~AB~Apr 12, 2011~No~RX~HIKMA PHARMACEUTICALS
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~HIKMA PHARMS~EQ 10MG BASE~A~

077771~003~AB~Apr 12, 2011~No~RX~HIKMA PHARMACEUTICALS
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~INVAGEN PHARMS~EQ 2.5MG BASE
~A~077955~001~AB~Aug 28, 2007~No~RX~INVAGEN PHARMACEUTICALS INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~INVAGEN PHARMS~EQ 5MG BASE~A
~077955~002~AB~Aug 28, 2007~No~RX~INVAGEN PHARMACEUTICALS INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~INVAGEN PHARMS~EQ 10MG BASE~
A~077955~003~AB~Aug 28, 2007~No~RX~INVAGEN PHARMACEUTICALS INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~LUPIN~EQ 2.5MG BASE~A~078043
~001~AB~Jul 12, 2007~No~RX~LUPIN LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~LUPIN~EQ 5MG BASE~A~078043~0
02~AB~Jul 12, 2007~No~RX~LUPIN LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~LUPIN~EQ 10MG BASE~A~078043~
003~AB~Jul 12, 2007~No~RX~LUPIN LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MACLEODS PHARMS LTD~EQ 5MG B
ASE~A~201380~001~AB~Apr 13, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MACLEODS PHARMS LTD~EQ 10MG
BASE~A~201380~002~AB~Apr 13, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MATRIX LABS LTD~EQ 2.5MG BAS
E~A~078224~001~AB~Feb 27, 2008~No~RX~MATRIX LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MATRIX LABS LTD~EQ 5MG BASE~
A~078224~002~AB~Feb 27, 2008~No~RX~MATRIX LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MATRIX LABS LTD~EQ 10MG BASE
~A~078224~003~AB~Feb 27, 2008~No~RX~MATRIX LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MUTUAL PHARMA~EQ 2.5MG BASE~
A~078081~001~~Jan 31, 2008~No~DISCN~MUTUAL PHARMACAL CO
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MUTUAL PHARMA~EQ 5MG BASE~A~
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MUTUAL PHARMA~EQ 10MG BASE~A
~078081~003~~Jan 31, 2008~No~DISCN~MUTUAL PHARMACAL CO
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MYLAN~EQ 2.5MG BASE~A~076418
~001~AB~Oct 3, 2005~No~RX~MYLAN LABORATORIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MYLAN~EQ 5MG BASE~A~076418~0
02~AB~Oct 3, 2005~No~RX~MYLAN LABORATORIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~MYLAN~EQ 10MG BASE~A~076418~
003~AB~Oct 3, 2005~No~RX~MYLAN LABORATORIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ORCHID HLTHCARE~EQ 2.5MG BAS
E~A~078453~001~AB~Jul 2, 2009~No~RX~ORCHID HEALTHCARE
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ORCHID HLTHCARE~EQ 5MG BASE~
A~078453~002~AB~Jul 2, 2009~No~RX~ORCHID HEALTHCARE
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ORCHID HLTHCARE~EQ 10MG BASE
~A~078453~003~AB~Jul 2, 2009~No~RX~ORCHID HEALTHCARE
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~PURACAP PHARM~EQ 2.5MG BASE~
A~078131~001~~Sep 4, 2007~No~DISCN~PURACAP PHARMACEUTICAL LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~PURACAP PHARM~EQ 5MG BASE~A~
078131~002~~Sep 4, 2007~No~DISCN~PURACAP PHARMACEUTICAL LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~PURACAP PHARM~EQ 10MG BASE~A
~078131~003~~Sep 4, 2007~No~DISCN~PURACAP PHARMACEUTICAL LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~RANBAXY~EQ 2.5MG BASE~A~0779
74~001~AB~Jul 9, 2007~No~RX~RANBAXY LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~RANBAXY~EQ 5MG BASE~A~077974
~002~AB~Jul 9, 2007~No~RX~RANBAXY LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~RANBAXY~EQ 10MG BASE~A~07797
4~003~AB~Jul 9, 2007~No~RX~RANBAXY LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ROXANE~EQ 2.5MG BASE~A~07726
2~001~AB~Jul 9, 2007~No~RX~ROXANE LABORATORIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ROXANE~EQ 5MG BASE~A~077262~
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ROXANE~EQ 10MG BASE~A~077262
~003~AB~Jul 9, 2007~No~RX~ROXANE LABORATORIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SANDOZ~EQ 2.5MG BASE~A~07685

9~001~~Sep 10, 2007~No~DISCN~SANDOZ INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SANDOZ~EQ 5MG BASE~A~076859~
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SANDOZ~EQ 10MG BASE~A~076859
~003~~Sep 10, 2007~No~DISCN~SANDOZ INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SECAN PHARMS~EQ 5MG BASE~A~0
90752~001~AB~Apr 15, 2011~No~RX~SECAN PHARMACEUTICALS INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SECAN PHARMS~EQ 10MG BASE~A~
090752~002~AB~Apr 15, 2011~No~RX~SECAN PHARMACEUTICALS INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SUN PHARM INDS INC~EQ 2.5MG
BASE~A~078231~001~AB~Nov 30, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SUN PHARM INDS INC~EQ 5MG BA
SE~A~078231~002~AB~Nov 30, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SUN PHARM INDS INC~EQ 10MG B
ASE~A~078231~003~AB~Nov 30, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SYNTHON PHARMS~EQ 2.5MG BASE
~A~077080~001~~Jun 27, 2007~No~DISCN~SYNTHON PHARMACEUTICALS INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SYNTHON PHARMS~EQ 5MG BASE~A
~077080~002~~Jun 27, 2007~No~DISCN~SYNTHON PHARMACEUTICALS INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~SYNTHON PHARMS~EQ 10MG BASE~
A~077080~003~~Jun 27, 2007~No~DISCN~SYNTHON PHARMACEUTICALS INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~TEVA~EQ 2.5MG BASE~A~076846~
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~TEVA~EQ 5MG BASE~A~076846~00
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~TEVA~EQ 10MG BASE~A~076846~0
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~TORRENT PHARMS~EQ 2.5MG BASE
~A~078573~001~AB~Sep 22, 2008~No~RX~TORRENT PHARMACEUTICALS LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~TORRENT PHARMS~EQ 5MG BASE~A
~078573~002~AB~Sep 22, 2008~No~RX~TORRENT PHARMACEUTICALS LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~TORRENT PHARMS~EQ 10MG BASE~
A~078573~003~AB~Sep 22, 2008~No~RX~TORRENT PHARMACEUTICALS LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~UNICHEM LABS LTD~EQ 2.5MG BA
SE~A~203245~001~AB~Oct 21, 2013~No~RX~UNICHEM LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~UNICHEM LABS LTD~EQ 5MG BASE
~A~203245~002~AB~Oct 21, 2013~No~RX~UNICHEM LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~UNICHEM LABS LTD~EQ 10MG BAS
E~A~203245~003~AB~Oct 21, 2013~No~RX~UNICHEM LABORATORIES LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~UPSHER SMITH~EQ 2.5MG BASE~A
~077759~001~AB~Jul 9, 2007~No~RX~UPSHER SMITH LABORATORIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~UPSHER SMITH~EQ 5MG BASE~A~0
77759~002~AB~Jul 9, 2007~No~RX~UPSHER SMITH LABORATORIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~UPSHER SMITH~EQ 10MG BASE~A~
077759~003~AB~Jul 9, 2007~No~RX~UPSHER SMITH LABORATORIES INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~VINTAGE~EQ 2.5MG BASE~A~0784
14~001~AB~Apr 7, 2010~No~RX~VINTAGE PHARMACEUTICALS LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~VINTAGE~EQ 5MG BASE~A~078414
~002~AB~Apr 7, 2010~No~RX~VINTAGE PHARMACEUTICALS LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~VINTAGE~EQ 10MG BASE~A~07841
4~003~AB~Apr 7, 2010~No~RX~VINTAGE PHARMACEUTICALS LLC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~VIVIMED LABS~EQ 2.5MG BASE~A
~077516~001~AB~Jul 11, 2007~No~RX~VIVIMED LABS ALATHUR PRIVATE LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~VIVIMED LABS~EQ 5MG BASE~A~0
77516~002~AB~Jul 11, 2007~No~RX~VIVIMED LABS ALATHUR PRIVATE LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~VIVIMED LABS~EQ 10MG BASE~A~
077516~003~AB~Jul 11, 2007~No~RX~VIVIMED LABS ALATHUR PRIVATE LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~WATSON LABS~EQ 2.5MG BASE~A~
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~WATSON LABS~EQ 5MG BASE~A~07

AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~WATSON LABS~EQ 10MG BASE~A~0
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~WOCKHARDT~EQ 2.5MG BASE~A~07
8500~001~AB~Sep 6, 2007~No~RX~WOCKHARDT LTD
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~WOCKHARDT~EQ 5MG BASE~A~0785
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~WOCKHARDT~EQ 10MG BASE~A~078
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ZYDUS PHARMS USA~EQ 2.5MG BA
SE~A~078226~001~AB~Jul 9, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ZYDUS PHARMS USA~EQ 5MG BASE
~A~078226~002~AB~Jul 9, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
AMLODIPINE BESYLATE~TABLET;ORAL~AMLODIPINE BESYLATE~ZYDUS PHARMS USA~EQ 10MG BAS
E~A~078226~003~AB~Jul 9, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM~TABLET;ORAL~AMLODIPINE BESYLATE AND AT
ORVASTATIN CALCIUM~DR REDDYS LABS LTD~EQ 2.5MG BASE;EQ 10MG BASE~A~203874~001~AB
~Mar 7, 2014~No~RX~DR REDDYS LABORATORIES LTD
ORVASTATIN CALCIUM~DR REDDYS LABS LTD~EQ 5MG BASE;EQ 10MG BASE~A~203874~004~AB~M
ar 7, 2014~No~RX~DR REDDYS LABORATORIES LTD
ORVASTATIN CALCIUM~DR REDDYS LABS LTD~EQ 10MG BASE;EQ 10MG BASE~A~203874~008~AB~
Mar 7, 2014~No~RX~DR REDDYS LABORATORIES LTD
ORVASTATIN CALCIUM~MYLAN PHARMS INC~EQ 2.5MG BASE;EQ 10MG BASE~A~200465~001~AB~N
ov 29, 2013~No~RX~MYLAN PHARMACEUTICALS INC
ORVASTATIN CALCIUM~MYLAN PHARMS INC~EQ 5MG BASE;EQ 10MG BASE~A~200465~004~AB~Nov

ORVASTATIN CALCIUM~MYLAN PHARMS INC~EQ 10MG BASE;EQ 10MG BASE~A~200465~008~AB~No
v 29, 2013~No~RX~MYLAN PHARMACEUTICALS INC
AMLODIPINE BESYLATE; VALSARTAN~TABLET;ORAL~AMLODIPINE BESYLATE AND VALSARTAN~PAR
PHARM INC~EQ 5MG BASE;160MG~A~090011~001~AB~Mar 28, 2013~No~RX~PAR PHARMACEUTIC
AL INC
PHARM INC~EQ 5MG BASE;320MG~A~090144~001~AB~Mar 28, 2013~No~RX~PAR PHARMACEUTIC
AL INC
PHARM INC~EQ 10MG BASE;160MG~A~090011~002~AB~Mar 28, 2013~No~RX~PAR PHARMACEUTI
CAL INC
PHARM INC~EQ 10MG BASE;320MG~A~090011~004~AB~Mar 28, 2013~No~RX~PAR PHARMACEUTI
CAL INC
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~AMLODIPINE,VALSARTAN AND
HYDROCHLOROTHIAZIDE~TEVA PHARMS~5MG;12.5MG;160MG~A~200435~001~AB~Sep 25, 2012~No
HYDROCHLOROTHIAZIDE~TEVA PHARMS~5MG;25MG;160MG~A~200435~002~AB~Sep 25, 2012~No~R
HYDROCHLOROTHIAZIDE~TEVA PHARMS~10MG;12.5MG;160MG~A~200435~005~AB~Sep 25, 2012~N
HYDROCHLOROTHIAZIDE~TEVA PHARMS~10MG;25MG;160MG~A~200435~003~AB~Sep 25, 2012~No~
HYDROCHLOROTHIAZIDE~TEVA PHARMS~10MG;25MG;320MG~A~200435~004~AB~Sep 25, 2012~No~
ESTROGENS, ESTERIFIED~TABLET;ORAL~AMNESTROGEN~BRISTOL MYERS SQUIBB~0.3MG~A~08326
MEPROBAMATE~TABLET;ORAL~AMOSENE~FERNDALE LABS~400MG~A~084030~001~~Approved Prior
to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
AMOXAPINE~TABLET;ORAL~AMOXAPINE~SANDOZ~25MG~A~072943~001~~Jun 28, 1991~No~DISCN~
SANDOZ INC
AMOXAPINE~TABLET;ORAL~AMOXAPINE~SANDOZ~50MG~A~072944~001~~Jun 28, 1991~No~DISCN~
SANDOZ INC
AMOXAPINE~TABLET;ORAL~AMOXAPINE~SANDOZ~100MG~A~072878~001~~Jun 28, 1991~No~DISCN
~SANDOZ INC
AMOXAPINE~TABLET;ORAL~AMOXAPINE~SANDOZ~150MG~A~072879~001~~Jun 28, 1991~No~DISCN
~SANDOZ INC
AMOXAPINE~TABLET;ORAL~AMOXAPINE~WATSON LABS~25MG~A~072418~001~~May 11, 1989~No~D
AMOXAPINE~TABLET;ORAL~AMOXAPINE~WATSON LABS~25MG~A~072688~001~~Aug 28, 1992~No~R
AMOXAPINE~TABLET;ORAL~AMOXAPINE~WATSON LABS~50MG~A~072419~001~~May 11, 1989~No~D
AMOXAPINE~TABLET;ORAL~AMOXAPINE~WATSON LABS~50MG~A~072689~001~~Aug 28, 1992~No~R
AMOXAPINE~TABLET;ORAL~AMOXAPINE~WATSON LABS~100MG~A~072420~001~~May 11, 1989~No~
AMOXAPINE~TABLET;ORAL~AMOXAPINE~WATSON LABS~100MG~A~072690~001~~Aug 28, 1992~No~
AMOXAPINE~TABLET;ORAL~AMOXAPINE~WATSON LABS~150MG~A~072421~001~~May 11, 1989~No~
AMOXAPINE~TABLET;ORAL~AMOXAPINE~WATSON LABS~150MG~A~072691~001~~Aug 28, 1992~Yes
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~AUROBINDO~500MG~A~065256~001~AB~Nov 9, 2005~
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~AUROBINDO~875MG~A~065256~002~AB~Nov 9, 2005~
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~DAVA PHARMS INC~875MG~A~065344~001~~Jan 15,
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~HIKMA~875MG~A~065255~001~AB~Mar 29, 2006~No~
RX~HIKMA PHARMACEUTICALS
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~RANBAXY~500MG~A~065059~001~AB~Nov 24, 2000~N
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~RANBAXY~875MG~A~065059~002~AB~Nov 24, 2000~N
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~SANDOZ~500MG~A~065228~001~AB~Jul 13, 2005~No
~RX~SANDOZ INC
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~SANDOZ~875MG~A~065228~002~AB~Jul 13, 2005~No
~RX~SANDOZ INC
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~TEVA~500MG~A~065056~001~AB~Sep 18, 2000~No~R
AMOXICILLIN~TABLET;ORAL~AMOXICILLIN~TEVA~875MG~A~065056~002~AB~Sep 18, 2000~Yes~
AMOXICILLIN; CLAVULANATE POTASSIUM~TABLET;ORAL~AMOXICILLIN AND CLAVULANATE POTAS
SIUM~APOTEX INC~250MG;EQ 125MG BASE~A~065333~001~~Feb 24, 2009~No~DISCN~APOTEX I
NC
SIUM~APOTEX INC~500MG;EQ 125MG BASE~A~065333~002~~Feb 24, 2009~No~DISCN~APOTEX I
NC
SIUM~APOTEX INC~875MG;EQ 125MG BASE~A~065317~003~~Oct 20, 2008~No~DISCN~APOTEX I
NC
SIUM~AUROBINDO PHARMA LTD~250MG;EQ 125MG BASE~A~091569~001~AB~Jan 20, 2012~No~RX
~AUROBINDO PHARMA LTD

SIUM~RANBAXY~875MG;EQ 125MG BASE~A~065102~001~AB~Sep 17, 2002~No~RX~RANBAXY PHAR
MACEUTICALS INC
SIUM~RANBAXY LABS~500MG;EQ 125MG BASE~A~065109~001~~Nov 4, 2002~No~DISCN~RANBAXY
LABORATORIES LTD
SIUM~SANDOZ~250MG;EQ 125MG BASE~A~065189~001~AB~Aug 23, 2005~No~RX~SANDOZ INC
SIUM~SANDOZ~500MG;EQ 125MG BASE~A~065064~001~AB~Mar 15, 2002~No~RX~SANDOZ INC
SIUM~SANDOZ~875MG;EQ 125MG BASE~A~065063~001~AB~Mar 14, 2002~No~RX~SANDOZ INC
SIUM~SANDOZ INC~500MG;EQ 125MG BASE~A~065117~001~AB~Nov 27, 2002~No~RX~SANDOZ IN
C
SIUM~SANDOZ INC~875MG;EQ 125MG BASE~A~065093~001~AB~Nov 21, 2002~No~RX~SANDOZ IN
C
SIUM~TEVA~500MG;EQ 125MG BASE~A~065101~001~AB~Oct 30, 2002~No~RX~TEVA PHARMACEUT
ICALS USA INC
SIUM~TEVA PHARMS USA~875MG;EQ 125MG BASE~A~065096~001~AB~Oct 29, 2002~No~RX~TEVA
AMOXICILLIN~TABLET;ORAL~AMOXIL~DR REDDYS LABS INC~500MG~N~050754~002~AB~Jul 10,
1998~No~RX~DR REDDYS LABORATORIES INC
AMOXICILLIN~TABLET;ORAL~AMOXIL~DR REDDYS LABS INC~875MG~N~050754~001~AB~Jul 10,
AMPHETAMINE SULFATE~TABLET;ORAL~AMPHETAMINE SULFATE~ARBOR PHARMS LLC~5MG~A~20016
6~001~~Aug 9, 2012~No~RX~ARBOR PHARMACEUTICALS LLC
AMPHETAMINE SULFATE~TABLET;ORAL~AMPHETAMINE SULFATE~ARBOR PHARMS LLC~10MG~A~2001
66~002~~Aug 9, 2012~Yes~RX~ARBOR PHARMACEUTICALS LLC
AMPHETAMINE SULFATE~TABLET;ORAL~AMPHETAMINE SULFATE~LANNETT~5MG~A~083901~001~~Au
g 31, 1984~No~DISCN~LANNETT CO INC
AMPHETAMINE SULFATE~TABLET;ORAL~AMPHETAMINE SULFATE~LANNETT~10MG~A~083901~002~~A
ug 31, 1984~No~DISCN~LANNETT CO INC
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~AMT
URNIDE~NOVARTIS~EQ 150MG BASE;EQ 5MG BASE;12.5MG~N~200045~001~~Dec 21, 2010~No~R
URNIDE~NOVARTIS~EQ 300MG BASE;EQ 5MG BASE;12.5MG~N~200045~002~~Dec 21, 2010~No~R
URNIDE~NOVARTIS~EQ 300MG BASE;EQ 5MG BASE;25MG~N~200045~003~~Dec 21, 2010~No~RX~
URNIDE~NOVARTIS~EQ 300MG BASE;EQ 10MG BASE;12.5MG~N~200045~004~~Dec 21, 2010~No~
URNIDE~NOVARTIS~EQ 300MG BASE;EQ 10MG BASE;25MG~N~200045~005~~Dec 21, 2010~Yes~R
AMLODIPINE MALEATE~TABLET;ORAL~AMVAZ~DR REDDYS LABS INC~2.5MG~N~021435~001~~Oct
31, 2003~No~DISCN~DR REDDYS LABORATORIES INC
AMLODIPINE MALEATE~TABLET;ORAL~AMVAZ~DR REDDYS LABS INC~5MG~N~021435~002~~Oct 31
, 2003~No~DISCN~DR REDDYS LABORATORIES INC
AMLODIPINE MALEATE~TABLET;ORAL~AMVAZ~DR REDDYS LABS INC~10MG~N~021435~003~~Oct 3
1, 2003~No~DISCN~DR REDDYS LABORATORIES INC
OXYMETHOLONE~TABLET;ORAL~ANADROL-50~MEDA PHARMS~50MG~N~016848~001~~Approved Prio
r to Jan 1, 1982~Yes~RX~MEDA PHARMACEUTICALS INC
NAPROXEN SODIUM~TABLET;ORAL~ANAPROX~HOFFMANN LA ROCHE~EQ 250MG BASE~N~018164~001

~AB~Approved Prior to Jan 1, 1982~No~RX~HOFFMANN LA ROCHE INC
NAPROXEN SODIUM~TABLET;ORAL~ANAPROX DS~HOFFMANN LA ROCHE~EQ 500MG BASE~N~018164~
003~AB~Sep 30, 1987~Yes~RX~HOFFMANN LA ROCHE INC
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~ACCORD HLTHCARE~1MG~A~090568~001~AB~Jun 28,
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~APOTEX INC~1MG~A~200654~001~AB~May 11, 2012~
No~RX~APOTEX INC
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~CIPLA LTD~1MG~A~091164~001~AB~Jun 28, 2010~N
o~RX~CIPLA LTD
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~DR REDDYS LABS LTD~1MG~A~090732~001~AB~Jun 2
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~FRESENIUS KABI ONCOL~1MG~A~090088~001~AB~Jun
28, 2010~No~RX~FRESENIUS KABI ONCOLOGY PLC
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~IMPAX LABS INC~1MG~A~091242~001~~May 31, 201
2~No~DISCN~IMPAX LABORATORIES INC
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~KUDCO IRELAND~1MG~A~091331~001~~Jan 5, 2011~
No~DISCN~KUDCO IRELAND LTD
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~MYLAN~1MG~A~091051~001~AB~Jun 28, 2010~No~RX
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~NATCO PHARMA LTD~1MG~A~079220~001~AB~Jun 28,
2010~No~RX~NATCO PHARMA LTD
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~ROXANE~1MG~A~078485~001~AB~Jun 28, 2010~No~R
X~ROXANE LABORATORIES INC
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~SANDOZ~1MG~A~079007~001~AB~Jun 28, 2010~No~R
X~SANDOZ INC
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~SANTOS BIOTECH~1MG~A~078944~001~AB~Jun 28, 2
010~No~RX~SANTOS BIOTECH INDUSTRIES INC
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~SUN PHARM INDS LTD~1MG~A~091177~001~AB~Jul 1
5, 2011~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD.
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~SYNTHON PHARMS~1MG~A~078322~001~~Jun 28, 201
0~No~DISCN~SYNTHON PHARMACEUTICALS INC
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~TEVA PHARMS~1MG~A~078058~001~AB~Jun 28, 2010
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~WATSON LABS~1MG~A~078984~001~~Jun 28, 2010~N
o~DISCN~WATSON LABORATORIES
ANASTROZOLE~TABLET;ORAL~ANASTROZOLE~ZYDUS PHARMS USA INC~1MG~A~078921~001~AB~Jun
METHYLTESTOSTERONE~TABLET;ORAL~ANDROID 10~VALEANT PHARM INTL~10MG~A~086450~001~B
P~Approved Prior to Jan 1, 1982~No~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
METHYLTESTOSTERONE~TABLET;ORAL~ANDROID 25~VALEANT PHARM INTL~25MG~A~087147~001~B
P~Approved Prior to Jan 1, 1982~No~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
FLUOXYMESTERONE~TABLET;ORAL~ANDROID-F~VALEANT PHARM INTL~10MG~A~087196~001~~Appr
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~ANEXSIA~MALLINCKRODT~500MG;5MG
~A~089160~001~~Apr 23, 1987~No~DISCN~MALLINCKRODT CHEMICAL INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~ANEXSIA~MALLINCKRODT~750MG;10M
G~A~040468~001~~Oct 31, 2002~No~DISCN~MALLINCKRODT INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~ANEXSIA 5/325~MALLINCKRODT~325
MG;5MG~A~040409~001~AA~Oct 20, 2000~No~RX~MALLINCKRODT INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~ANEXSIA 7.5/325~MALLINCKRODT~3
25MG;7.5MG~A~040405~001~AA~Sep 8, 2000~No~RX~MALLINCKRODT INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~ANEXSIA 7.5/650~MALLINCKRODT~6
50MG;7.5MG~A~089725~001~~Sep 30, 1987~No~DISCN~MALLINCKRODT CHEMICAL INC
DROSPIRENONE; ESTRADIOL~TABLET;ORAL~ANGELIQ~BAYER HLTHCARE~0.25MG;0.5MG~N~021355
~001~~Feb 29, 2012~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
DROSPIRENONE; ESTRADIOL~TABLET;ORAL~ANGELIQ~BAYER HLTHCARE~0.5MG;1MG~N~021355~00
2~~Sep 28, 2005~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
CYCLOTHIAZIDE~TABLET;ORAL~ANHYDRON~LILLY~2MG~N~013157~002~~Approved Prior to Jan
ANISOTROPINE METHYLBROMIDE~TABLET;ORAL~ANISOTROPINE METHYLBROMIDE~WATSON LABS~50

MG~A~086046~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
FLURBIPROFEN~TABLET;ORAL~ANSAID~PHARMACIA AND UPJOHN~50MG~N~018766~002~AB~Oct 31
, 1988~No~RX~PHARMACIA AND UPJOHN CO
FLURBIPROFEN~TABLET;ORAL~ANSAID~PHARMACIA AND UPJOHN~100MG~N~018766~003~AB~Oct 3
1, 1988~Yes~RX~PHARMACIA AND UPJOHN CO
DISULFIRAM~TABLET;ORAL~ANTABUSE~ODYSSEY PHARMS~250MG~A~088482~001~AB~Dec 8, 1983
~No~RX~ODYSSEY PHARMACEUTICALS INC
DISULFIRAM~TABLET;ORAL~ANTABUSE~ODYSSEY PHARMS~500MG~A~088483~001~AB~Dec 8, 1983
~Yes~RX~ODYSSEY PHARMACEUTICALS INC
DISULFIRAM~TABLET;ORAL~ANTABUSE~TEVA WOMENS~250MG~N~007883~003~~Approved Prior t
o Jan 1, 1982~No~DISCN~TEVA WOMENS HEALTH INC
DISULFIRAM~TABLET;ORAL~ANTABUSE~TEVA WOMENS~500MG~N~007883~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~TEVA WOMENS HEALTH INC
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~ANTAGONATE~BAYER PHARMS~4MG~A~083381~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
PIPERAZINE CITRATE~TABLET;ORAL~ANTEPAR~GLAXOSMITHKLINE~EQ 500MG BASE~N~009102~00
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~ANTIVERT~CITRON PHARMA LLC~12.5MG~N~010721~0
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~ANTIVERT~CITRON PHARMA LLC~25MG~N~010721~004
~~Approved Prior to Jan 1, 1982~No~DISCN~CITRON PHARMA LLC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~ANTIVERT~CITRON PHARMA LLC~50MG~N~010721~001
~~Jan 20, 1982~No~DISCN~CITRON PHARMA LLC
OXYPHENONIUM BROMIDE~TABLET;ORAL~ANTRENYL~NOVARTIS~5MG~N~008492~002~~Approved Pr
SULFINPYRAZONE~TABLET;ORAL~ANTURANE~NOVARTIS~100MG **Federal Register determinat
s**~N~011556~003~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICAL
S CORP
DOLASETRON MESYLATE~TABLET;ORAL~ANZEMET~SANOFI AVENTIS US~50MG~N~020623~001~~Sep
11, 1997~No~RX~SANOFI AVENTIS US LLC
DOLASETRON MESYLATE~TABLET;ORAL~ANZEMET~SANOFI AVENTIS US~100MG~N~020623~002~~Se
p 11, 1997~Yes~RX~SANOFI AVENTIS US LLC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~APRESOLINE~NOVARTIS~10MG~N~008303~004~~App
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~APRESOLINE~NOVARTIS~100MG~N~008303~005~~Ap
proved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~APRESOLINE-ESIDRIX~NO
VARTIS~25MG;15MG~N~012026~002~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS P
HARMACEUTICALS CORP
ESLICARBAZEPINE ACETATE~TABLET;ORAL~APTIOM~SUNOVION PHARMS INC~200MG~N~022416~00
1~~Nov 8, 2013~No~RX~SUNOVION PHARMACEUTICALS INC
4~~Nov 8, 2013~Yes~RX~SUNOVION PHARMACEUTICALS INC
BENZTHIAZIDE~TABLET;ORAL~AQUATAG~SOLVAY~25MG~N~016001~001~~Approved Prior to Jan
BENZTHIAZIDE~TABLET;ORAL~AQUATAG~SOLVAY~50MG~N~016001~002~~Approved Prior to Jan
METHYCLOTHIAZIDE~TABLET;ORAL~AQUATENSEN~MEDPOINTE PHARM HLC~5MG~N~017364~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHC
ARE INC
CHLOROQUINE PHOSPHATE~TABLET;ORAL~ARALEN~SANOFI AVENTIS US~EQ 300MG BASE~N~00600

2~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE~TABLET;ORAL~ARALEN PHOSPHATE W/ PRIM
AQUINE PHOSPHATE~SANOFI AVENTIS US~EQ 300MG BASE;EQ 45MG BASE~N~014860~002~~Appr
oved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
LEFLUNOMIDE~TABLET;ORAL~ARAVA~SANOFI AVENTIS US~10MG~N~020905~001~AB~Sep 10, 199
LEFLUNOMIDE~TABLET;ORAL~ARAVA~SANOFI AVENTIS US~20MG~N~020905~002~AB~Sep 10, 199
LEFLUNOMIDE~TABLET;ORAL~ARAVA~SANOFI AVENTIS US~100MG~N~020905~003~~Sep 10, 1998
~Yes~RX~SANOFI AVENTIS US LLC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~ARICEPT~EISAI INC~5MG~N~020690~002~AB~Nov 25
, 1996~No~RX~EISAI INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~ARICEPT~EISAI INC~10MG~N~020690~001~AB~Nov 2
5, 1996~Yes~RX~EISAI INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~ARICEPT~EISAI INC~23MG~N~022568~001~AB~Jul 2
3, 2010~Yes~RX~EISAI INC
ANASTROZOLE~TABLET;ORAL~ARIMIDEX~ASTRAZENECA~1MG~N~020541~001~AB~Dec 27, 1995~Ye
s~RX~ASTRAZENECA UK LTD
TRIAMCINOLONE~TABLET;ORAL~ARISTOCORT~ASTELLAS~1MG~N~011161~009~~Approved Prior t
o Jan 1, 1982~No~DISCN~ASTELLAS PHARMA US INC
TRIAMCINOLONE~TABLET;ORAL~ARISTOCORT~ASTELLAS~16MG~N~011161~010~~Approved Prior
ARMODAFINIL~TABLET;ORAL~ARMODAFINIL~MYLAN PHARMS INC~50MG~A~200043~001~~Jun 1, 2
ARMODAFINIL~TABLET;ORAL~ARMODAFINIL~MYLAN PHARMS INC~150MG~A~200043~002~~Jun 1,
ARMODAFINIL~TABLET;ORAL~ARMODAFINIL~MYLAN PHARMS INC~250MG~A~200043~003~~Jun 1,
ARMODAFINIL~TABLET;ORAL~ARMODAFINIL~WATSON LABS INC~100MG~A~200156~002~~Aug 29,
ARMODAFINIL~TABLET;ORAL~ARMODAFINIL~WATSON LABS INC~200MG~A~200156~004~~Aug 29,
EXEMESTANE~TABLET;ORAL~AROMASIN~PHARMACIA AND UPJOHN~25MG~N~020753~001~AB~Oct 21
, 1999~Yes~RX~PHARMACIA AND UPJOHN CO
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~ARTANE~LEDERLE~2MG~N~006773~005~~Appro
ved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~ARTANE~LEDERLE~5MG~N~006773~003~~Appro
THEOPHYLLINE SODIUM GLYCINATE~TABLET;ORAL~ASBRON~NOVARTIS~EQ 150MG BASE~A~085148
~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS CONSUMER HEALTH INC
AMOXAPINE~TABLET;ORAL~ASENDIN~LEDERLE~25MG~N~018021~001~~Approved Prior to Jan 1
, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
AMOXAPINE~TABLET;ORAL~ASENDIN~LEDERLE~50MG~N~018021~002~~Approved Prior to Jan 1
, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
AMOXAPINE~TABLET;ORAL~ASENDIN~LEDERLE~100MG~N~018021~003~~Approved Prior to Jan
1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
AMOXAPINE~TABLET;ORAL~ASENDIN~LEDERLE~150MG~N~018021~004~~Approved Prior to Jan
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~ASHLYNA~GLENMARK GENERICS~0.03MG,0
.01MG;0.15MG,N/A~A~203163~001~AB~Feb 23, 2015~No~RX~GLENMARK GENERICS LTD
CANDESARTAN CILEXETIL~TABLET;ORAL~ATACAND~ASTRAZENECA~4MG~N~020838~001~AB~Jun 4,
CANDESARTAN CILEXETIL~TABLET;ORAL~ATACAND~ASTRAZENECA~8MG~N~020838~002~AB~Jun 4,
CANDESARTAN CILEXETIL~TABLET;ORAL~ATACAND~ASTRAZENECA~16MG~N~020838~003~AB~Jun 4
, 1998~No~RX~ASTRAZENECA PHARMACEUTICALS LP
CANDESARTAN CILEXETIL~TABLET;ORAL~ATACAND~ASTRAZENECA~32MG~N~020838~004~AB~Jun 4
, 1998~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ATACAND HCT~ASTRAZENECA~1
6MG;12.5MG~N~021093~001~AB~Sep 5, 2000~No~RX~ASTRAZENECA PHARMACEUTICALS LP
2MG;12.5MG~N~021093~002~AB~Sep 5, 2000~No~RX~ASTRAZENECA PHARMACEUTICALS LP
2MG;25MG~N~021093~003~AB~May 16, 2008~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~ATARAX~PFIZER~10MG~N~010392~001~~Approved
Prior to Jan 1, 1982~No~DISCN~PFIZER INC
ATENOLOL~TABLET;ORAL~ATENOLOL~ABLE~25MG~A~076907~001~~Jul 30, 2004~No~DISCN~ABLE
LABORATORIES INC
ATENOLOL~TABLET;ORAL~ATENOLOL~ABLE~50MG~A~076907~002~~Jul 30, 2004~No~DISCN~ABLE
LABORATORIES INC
ATENOLOL~TABLET;ORAL~ATENOLOL~ABLE~100MG~A~076907~003~~Jul 30, 2004~No~DISCN~ABL
E LABORATORIES INC
ATENOLOL~TABLET;ORAL~ATENOLOL~APOTHECON~50MG~A~073317~001~~Mar 20, 1992~No~DISCN
~APOTHECON SUB BRISTOL MYERS SQUIBB CO
ATENOLOL~TABLET;ORAL~ATENOLOL~APOTHECON~100MG~A~073318~001~~Mar 20, 1992~No~DISC
N~APOTHECON SUB BRISTOL MYERS SQUIBB CO
ATENOLOL~TABLET;ORAL~ATENOLOL~AUROBINDO PHARMA~25MG~A~078512~001~AB~Oct 31, 2007
ATENOLOL~TABLET;ORAL~ATENOLOL~DAVA PHARMS INC~25MG~A~074099~001~AB~Apr 28, 1992~
No~RX~DAVA PHARMACEUTICALS INC
ATENOLOL~TABLET;ORAL~ATENOLOL~DAVA PHARMS INC~50MG~A~073542~001~AB~Dec 19, 1991~
No~RX~DAVA PHARMACEUTICALS INC
ATENOLOL~TABLET;ORAL~ATENOLOL~DAVA PHARMS INC~100MG~A~073543~001~AB~Dec 19, 1991
~No~RX~DAVA PHARMACEUTICALS INC
ATENOLOL~TABLET;ORAL~ATENOLOL~IPCA LABS LTD~25MG~A~077877~001~AB~Dec 27, 2006~No
~RX~IPCA LABORATORIES LTD
ATENOLOL~TABLET;ORAL~ATENOLOL~IPCA LABS LTD~50MG~A~077877~002~AB~Dec 27, 2006~No
~RX~IPCA LABORATORIES LTD
ATENOLOL~TABLET;ORAL~ATENOLOL~IPCA LABS LTD~100MG~A~077877~003~AB~Dec 27, 2006~N
o~RX~IPCA LABORATORIES LTD
ATENOLOL~TABLET;ORAL~ATENOLOL~IPR~25MG~A~073646~001~AB~Jul 31, 1992~No~RX~IPR PH
ARMACEUTICALS INC
ATENOLOL~TABLET;ORAL~ATENOLOL~IPR~50MG~A~072303~001~AB~Jul 15, 1988~No~RX~IPR PH
ARMACEUTICALS INC
ATENOLOL~TABLET;ORAL~ATENOLOL~IPR~100MG~A~072304~001~AB~Jul 15, 1988~No~RX~IPR P
HARMACEUTICALS INC
ATENOLOL~TABLET;ORAL~ATENOLOL~MUTUAL PHARM~25MG~A~074499~001~AB~Jul 30, 1997~No~
RX~MUTUAL PHARMACEUTICAL CO INC
ATENOLOL~TABLET;ORAL~ATENOLOL~MUTUAL PHARM~50MG~A~073475~001~AB~Mar 30, 1993~No~
ATENOLOL~TABLET;ORAL~ATENOLOL~MUTUAL PHARM~100MG~A~073476~001~AB~Mar 30, 1993~No
~RX~MUTUAL PHARMACEUTICAL CO INC
ATENOLOL~TABLET;ORAL~ATENOLOL~MYLAN~25MG~A~073457~002~AB~Apr 26, 1999~No~RX~MYLA
ATENOLOL~TABLET;ORAL~ATENOLOL~MYLAN~25MG~A~074126~003~~Aug 26, 1998~No~DISCN~MYL
AN PHARMACEUTICALS INC
ATENOLOL~TABLET;ORAL~ATENOLOL~MYLAN~50MG~A~073457~003~AB~Jan 24, 1992~No~RX~MYLA
ATENOLOL~TABLET;ORAL~ATENOLOL~MYLAN~50MG~A~074126~001~~Mar 23, 1994~No~DISCN~MYL
ATENOLOL~TABLET;ORAL~ATENOLOL~MYLAN~100MG~A~073457~001~AB~Jan 24, 1992~No~RX~MYL
ATENOLOL~TABLET;ORAL~ATENOLOL~MYLAN~100MG~A~074126~002~~Mar 23, 1994~No~DISCN~MY
ATENOLOL~TABLET;ORAL~ATENOLOL~NORTHSTAR HLTHCARE~25MG~A~078254~001~AB~Sep 25, 20
09~No~RX~NORTHSTAR HEALTHCARE HOLDINGS LTD
ATENOLOL~TABLET;ORAL~ATENOLOL~NOSTRUM LABS~50MG~A~074127~001~~Feb 21, 1995~No~DI
SCN~NOSTRUM LABORATORIES INC
ATENOLOL~TABLET;ORAL~ATENOLOL~NOSTRUM LABS~100MG~A~074127~002~~Feb 21, 1995~No~D
ISCN~NOSTRUM LABORATORIES INC
ATENOLOL~TABLET;ORAL~ATENOLOL~PLIVA~25MG~A~074101~001~~Jul 17, 1997~No~DISCN~PLI
VA INC
ATENOLOL~TABLET;ORAL~ATENOLOL~PLIVA~50MG~A~074101~002~~Jul 17, 1997~No~DISCN~PLI
VA INC
ATENOLOL~TABLET;ORAL~ATENOLOL~PLIVA~100MG~A~074101~003~~Jul 17, 1997~No~DISCN~PL
IVA INC
ATENOLOL~TABLET;ORAL~ATENOLOL~SANDOZ~25MG~A~074052~001~AB~May 1, 1992~No~RX~SAND
OZ INC
ATENOLOL~TABLET;ORAL~ATENOLOL~SANDOZ~25MG~A~074265~001~~Feb 28, 1994~No~DISCN~SA
NDOZ INC
ATENOLOL~TABLET;ORAL~ATENOLOL~SANDOZ~50MG~A~073025~001~AB~Sep 17, 1991~No~RX~SAN
DOZ INC
ATENOLOL~TABLET;ORAL~ATENOLOL~SANDOZ~50MG~A~074265~002~~Feb 28, 1994~No~DISCN~SA
NDOZ INC
ATENOLOL~TABLET;ORAL~ATENOLOL~SANDOZ~100MG~A~073026~001~AB~Sep 17, 1991~No~RX~SA
NDOZ INC
ATENOLOL~TABLET;ORAL~ATENOLOL~SANDOZ~100MG~A~074265~003~~Feb 28, 1994~No~DISCN~S
ANDOZ INC
ATENOLOL~TABLET;ORAL~ATENOLOL~SCS~50MG~A~073676~001~~Oct 30, 1992~No~DISCN~SCS P
HARMACEUTICALS
ATENOLOL~TABLET;ORAL~ATENOLOL~SCS~100MG~A~073676~002~~Oct 30, 1992~No~DISCN~SCS
PHARMACEUTICALS
ATENOLOL~TABLET;ORAL~ATENOLOL~SUN PHARM INDS INC~25MG~A~078210~001~AB~Jul 10, 20
07~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
ATENOLOL~TABLET;ORAL~ATENOLOL~TEVA~25MG~A~074056~003~AB~Jul 19, 2004~No~RX~TEVA
ATENOLOL~TABLET;ORAL~ATENOLOL~TEVA~50MG~A~073315~001~~May 28, 1993~No~DISCN~TEVA
ATENOLOL~TABLET;ORAL~ATENOLOL~TEVA~50MG~A~074056~001~AB~Jan 18, 1995~No~RX~TEVA
ATENOLOL~TABLET;ORAL~ATENOLOL~TEVA~100MG~A~073316~001~~May 28, 1993~No~DISCN~TEV
ATENOLOL~TABLET;ORAL~ATENOLOL~TEVA~100MG~A~074056~002~AB~Jan 18, 1995~No~RX~TEVA
ATENOLOL~TABLET;ORAL~ATENOLOL~TEVA PHARMS~50MG~A~074120~001~~Feb 24, 1995~No~DIS
CN~TEVA PHARMACEUTICALS USA

ATENOLOL~TABLET;ORAL~ATENOLOL~TEVA PHARMS~100MG~A~074120~002~~Feb 24, 1995~No~DI
SCN~TEVA PHARMACEUTICALS USA
ATENOLOL~TABLET;ORAL~ATENOLOL~UNIQUE PHARM LABS~25MG~A~077443~001~AB~Sep 13, 200
6~No~RX~UNIQUE PHARMACEUTICAL LABORATORIES
ATENOLOL~TABLET;ORAL~ATENOLOL~WATSON LABS~50MG~A~073352~001~~Dec 27, 1991~No~DIS
ATENOLOL~TABLET;ORAL~ATENOLOL~WATSON LABS~100MG~A~073353~001~~Dec 27, 1991~No~DI
ATENOLOL~TABLET;ORAL~ATENOLOL~ZYDUS PHARMS USA~25MG~A~076900~001~AB~Jan 28, 2005
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~IPR~50MG;25MG~A
~072301~001~AB~May 31, 1990~No~RX~IPR PHARMACEUTICALS INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~IPR~100MG;25MG~
A~072302~001~AB~May 31, 1990~No~RX~IPR PHARMACEUTICALS INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~MUTUAL PHARM~50
MG;25MG~A~073581~001~AB~Apr 29, 1993~No~RX~MUTUAL PHARMACEUTICAL CO INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~MUTUAL PHARM~10
0MG;25MG~A~073582~001~AB~Apr 29, 1993~No~RX~MUTUAL PHARMACEUTICAL CO INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~MYLAN~50MG;25MG
~A~074203~001~AB~Oct 31, 1993~No~RX~MYLAN PHARMACEUTICALS INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~MYLAN~100MG;25M
G~A~074203~002~AB~Oct 31, 1993~No~RX~MYLAN PHARMACEUTICALS INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~NOSTRUM LABS~50
MG;25MG~A~074404~001~~May 14, 1998~No~DISCN~NOSTRUM LABORATORIES INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~NOSTRUM LABS~10
0MG;25MG~A~074404~002~~May 14, 1998~No~DISCN~NOSTRUM LABORATORIES INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~PLIVA~50MG;25MG
~A~074107~001~~Sep 24, 1997~No~DISCN~PLIVA INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~PLIVA~100MG;25M
G~A~074107~002~~Sep 24, 1997~No~DISCN~PLIVA INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~WATSON LABS~50M
G;25MG~A~073665~001~AB~Jul 2, 1992~No~RX~WATSON LABORATORIES INC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~ATENOLOL AND CHLORTHALIDONE~WATSON LABS~100
MG;25MG~A~073665~002~AB~Jul 2, 1992~No~RX~WATSON LABORATORIES INC
WARFARIN SODIUM~TABLET;ORAL~ATHROMBIN~PHARM RES ASSOC~5MG~N~011771~003~~Approved
Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
WARFARIN SODIUM~TABLET;ORAL~ATHROMBIN~PHARM RES ASSOC~10MG~N~011771~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
WARFARIN SODIUM~TABLET;ORAL~ATHROMBIN~PHARM RES ASSOC~25MG~N~011771~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
WARFARIN POTASSIUM~TABLET;ORAL~ATHROMBIN-K~PHARM RES ASSOC~2MG~N~011771~007~~App
roved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
WARFARIN POTASSIUM~TABLET;ORAL~ATHROMBIN-K~PHARM RES ASSOC~5MG~N~011771~004~~App
roved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
WARFARIN POTASSIUM~TABLET;ORAL~ATHROMBIN-K~PHARM RES ASSOC~10MG~N~011771~005~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
WARFARIN POTASSIUM~TABLET;ORAL~ATHROMBIN-K~PHARM RES ASSOC~25MG~N~011771~006~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
LORAZEPAM~TABLET;ORAL~ATIVAN~VALEANT INTL~0.5MG~N~017794~001~AB~Approved Prior t
o Jan 1, 1982~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
LORAZEPAM~TABLET;ORAL~ATIVAN~VALEANT INTL~1MG~N~017794~002~AB~Approved Prior to
Jan 1, 1982~No~RX~VALEANT INTERNATIONAL BARBADOS SRL

LORAZEPAM~TABLET;ORAL~ATIVAN~VALEANT INTL~2MG~N~017794~003~AB~Approved Prior to
Jan 1, 1982~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
ATORVASTATIN CALCIUM~TABLET;ORAL~ATORVASTATIN CALCIUM~APOTEX INC~EQ 10MG BASE~A~
ATORVASTATIN CALCIUM~TABLET;ORAL~ATORVASTATIN CALCIUM~DR REDDYS LABS LTD~EQ 10MG
ATORVASTATIN CALCIUM~TABLET;ORAL~ATORVASTATIN CALCIUM~KUDCO IRELAND~EQ 10MG BASE
~A~091624~001~AB~Apr 5, 2013~No~RX~KUDCO IRELAND LTD
ATORVASTATIN CALCIUM~TABLET;ORAL~ATORVASTATIN CALCIUM~MYLAN PHARMS INC~EQ 10MG B
ASE~A~091226~001~AB~May 29, 2012~No~RX~MYLAN PHARMACEUTICALS INC
ATORVASTATIN CALCIUM~TABLET;ORAL~ATORVASTATIN CALCIUM~RANBAXY LABS LTD~EQ 10MG B
ASE~A~076477~001~AB~Nov 30, 2011~No~RX~RANBAXY LABORATORIES LTD
ATORVASTATIN CALCIUM~TABLET;ORAL~ATORVASTATIN CALCIUM~SANDOZ INC~EQ 10MG BASE~A~
077575~001~AB~May 29, 2012~No~RX~SANDOZ INC
ATORVASTATIN CALCIUM~TABLET;ORAL~ATORVASTATIN CALCIUM~TEVA PHARMS~EQ 10MG BASE~A
~078773~001~~May 29, 2012~No~DISCN~TEVA PHARMACEUTICALS USA
ATOVAQUONE; PROGUANIL HYDROCHLORIDE~TABLET;ORAL~ATOVAQUONE AND PROGUANIL HYDROCH
LORIDE~GLENMARK GENERICS~250MG;100MG~A~091211~001~AB~Jan 12, 2011~No~RX~GLENMARK

GENERICS LTD
LORIDE~MYLAN PHARMS INC~62.5MG;25MG~A~202362~001~AB~May 27, 2014~No~RX~MYLAN PHA
RMACEUTICALS INC
LORIDE~MYLAN PHARMS INC~250MG;100MG~A~202362~002~AB~May 27, 2014~No~RX~MYLAN PHA
RMACEUTICALS INC
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE~TABLET;ORAL~ATRIPLA~GILE
AD~600MG;200MG;300MG~N~021937~001~~Jul 12, 2006~Yes~RX~GILEAD SCIENCES INC
TERIFLUNOMIDE~TABLET;ORAL~AUBAGIO~SANOFI AVENTIS US~7MG~N~202992~001~~Sep 12, 20
TERIFLUNOMIDE~TABLET;ORAL~AUBAGIO~SANOFI AVENTIS US~14MG~N~202992~002~~Sep 12, 2
AMOXICILLIN; CLAVULANATE POTASSIUM~TABLET;ORAL~AUGMENTIN '250'~DR REDDYS LABS IN
C~250MG;EQ 125MG BASE~N~050564~001~AB~Aug 6, 1984~Yes~RX~DR REDDYS LABORATORIES
INC
C~500MG;EQ 125MG BASE~N~050564~002~AB~Aug 6, 1984~Yes~RX~DR REDDYS LABORATORIES
INC
C~875MG;EQ 125MG BASE~N~050720~001~AB~Feb 13, 1996~Yes~RX~DR REDDYS LABORATORIES
INC
FERRIC CITRATE~TABLET;ORAL~AURYXIA~KERYX BIOPHARMS~EQ 210MG IRON~N~205874~001~~S
ep 5, 2014~Yes~RX~KERYX BIOPHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~AVALIDE~SANOFI AVENTIS US~12.5MG;75M
n for safety or efficacy reasons**~N~020758~001~~Sep 30, 1997~No~DISCN~SANOFI AV
ENTIS US LLC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~AVALIDE~SANOFI AVENTIS US~12.5MG;150
MG~N~020758~002~AB~Sep 30, 1997~Yes~RX~SANOFI AVENTIS US LLC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~AVALIDE~SANOFI AVENTIS US~12.5MG;300
MG~N~020758~003~AB~Aug 31, 1998~Yes~RX~SANOFI AVENTIS US LLC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~AVALIDE~SANOFI AVENTIS US~25MG;300MG
for safety or efficacy reasons**~N~020758~004~~Mar 15, 2005~No~DISCN~SANOFI AVE
NTIS US LLC
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE~TABLET;ORAL~AVANDAMET~SB PHARMCO~
1GM;EQ 2MG BASE~N~021410~004~AB~Aug 25, 2003~No~RX~SB PHARMCO PUERTO RICO INC
1GM;EQ 4MG BASE~N~021410~005~AB~Aug 25, 2003~Yes~RX~SB PHARMCO PUERTO RICO INC
500MG;EQ 1MG BASE **Federal Register determination that product was not disconti
nued or withdrawn for safety or efficacy reasons**~N~021410~001~~Oct 10, 2002~No
~DISCN~SB PHARMCO PUERTO RICO INC
500MG;EQ 2MG BASE~N~021410~002~AB~Oct 10, 2002~No~RX~SB PHARMCO PUERTO RICO INC
500MG;EQ 4MG BASE~N~021410~003~AB~Oct 10, 2002~No~RX~SB PHARMCO PUERTO RICO INC
GLIMEPIRIDE; ROSIGLITAZONE MALEATE~TABLET;ORAL~AVANDARYL~SB PHARMCO~1MG;4MG~N~02
1700~001~~Nov 23, 2005~Yes~RX~SB PHARMCO PUERTO RICO INC
1700~002~~Nov 23, 2005~No~RX~SB PHARMCO PUERTO RICO INC
1700~004~~Mar 30, 2007~No~RX~SB PHARMCO PUERTO RICO INC
1700~003~~Nov 23, 2005~No~RX~SB PHARMCO PUERTO RICO INC
1700~005~~Mar 30, 2007~No~RX~SB PHARMCO PUERTO RICO INC
ROSIGLITAZONE MALEATE~TABLET;ORAL~AVANDIA~SB PHARMCO~EQ 2MG BASE~N~021071~002~AB
~May 25, 1999~No~RX~SB PHARMCO PUERTO RICO INC

~May 25, 1999~No~RX~SB PHARMCO PUERTO RICO INC
~May 25, 1999~Yes~RX~SB PHARMCO PUERTO RICO INC
IRBESARTAN~TABLET;ORAL~AVAPRO~SANOFI AVENTIS US~75MG~N~020757~001~AB~Sep 30, 199
MOXIFLOXACIN HYDROCHLORIDE~TABLET;ORAL~AVELOX~BAYER HLTHCARE~EQ 400MG BASE~N~021
085~001~AB~Dec 10, 1999~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
ALMOTRIPTAN MALATE~TABLET;ORAL~AXERT~JANSSEN PHARMS~EQ 6.25MG BASE~N~021001~001~
~May 7, 2001~No~RX~JANSSEN PHARMACEUTICALS INC
ALMOTRIPTAN MALATE~TABLET;ORAL~AXERT~JANSSEN PHARMS~EQ 12.5MG BASE~N~021001~002~
~May 7, 2001~Yes~RX~JANSSEN PHARMACEUTICALS INC
NIZATIDINE~TABLET;ORAL~AXID AR~PFIZER~75MG~N~020555~001~~May 9, 1996~Yes~OTC~PFI
ZER INC
ASPIRIN; BUTALBITAL~TABLET;ORAL~AXOTAL~SAVAGE LABS~650MG;50MG~A~088305~001~~Oct
NORETHINDRONE ACETATE~TABLET;ORAL~AYGESTIN~DURAMED RES~5MG~N~018405~001~AB~Apr 2
1, 1982~Yes~RX~DURAMED RESEARCH INC
AZATHIOPRINE~TABLET;ORAL~AZASAN~AAIPHARMA LLC~25MG~A~075252~002~AB~Feb 3, 2003~N
o~RX~AAIPHARMA LLC
AZATHIOPRINE~TABLET;ORAL~AZASAN~AAIPHARMA LLC~50MG~A~075252~001~AB~Jun 7, 1999~N
o~RX~AAIPHARMA LLC
AZATHIOPRINE~TABLET;ORAL~AZASAN~AAIPHARMA LLC~75MG~A~075252~003~AB~Feb 3, 2003~N
o~RX~AAIPHARMA LLC
AZATHIOPRINE~TABLET;ORAL~AZASAN~AAIPHARMA LLC~100MG~A~075252~004~AB~Feb 3, 2003~
No~RX~AAIPHARMA LLC
AZATHIOPRINE~TABLET;ORAL~AZATHIOPRINE~AMNEAL PHARMS LLC~50MG~A~074069~001~AB~Feb
16, 1996~No~RX~AMNEAL PHARMACEUTICALS LLC
AZATHIOPRINE~TABLET;ORAL~AZATHIOPRINE~MYLAN~50MG~A~075568~001~AB~Dec 13, 1999~No
~RX~MYLAN PHARMACEUTICALS INC
AZATHIOPRINE~TABLET;ORAL~AZATHIOPRINE~ZYDUS PHARMS USA~25MG~A~077621~002~AB~Sep
AZATHIOPRINE~TABLET;ORAL~AZATHIOPRINE~ZYDUS PHARMS USA~50MG~A~077621~001~AB~Mar
ASPIRIN; HYDROCODONE BITARTRATE~TABLET;ORAL~AZDONE~SCHWARZ PHARMA~500MG;5MG **Fe
safety or efficacy reasons**~A~089420~001~~Jan 25, 1988~No~DISCN~SCHWARZ PHARMA
INC
RASAGILINE MESYLATE~TABLET;ORAL~AZILECT~TEVA~EQ 0.5MG BASE~N~021641~001~AB~May 1
6, 2006~No~RX~TEVA NEUROSCIENCE INC
RASAGILINE MESYLATE~TABLET;ORAL~AZILECT~TEVA~EQ 1MG BASE~N~021641~002~AB~May 16,
2006~Yes~RX~TEVA NEUROSCIENCE INC
AZITHROMYCIN~TABLET;ORAL~AZITHROMYCIN~APOTEX CORP~EQ 250MG BASE~A~065507~001~AB~
Jul 13, 2011~No~RX~APOTEX CORP
AZITHROMYCIN~TABLET;ORAL~AZITHROMYCIN~MYLAN~EQ 250MG BASE~A~065365~001~AB~May 30
AZITHROMYCIN~TABLET;ORAL~AZITHROMYCIN~MYLAN~EQ 500MG BASE~A~065366~001~AB~May 30

AZITHROMYCIN~TABLET;ORAL~AZITHROMYCIN~MYLAN~EQ 600MG BASE~A~065360~001~AB~Jan 8,
AZITHROMYCIN~TABLET;ORAL~AZITHROMYCIN~PLIVA~EQ 250MG BASE~A~065225~001~AB~Nov 14
, 2005~No~RX~PLIVA INC
AZITHROMYCIN~TABLET;ORAL~AZITHROMYCIN~SANDOZ~EQ 250MG BASE~A~065211~001~AB~Nov 1
AZITHROMYCIN~TABLET;ORAL~AZITHROMYCIN~TEVA~EQ 250MG BASE~A~065153~001~AB~Nov 14,
AZITHROMYCIN~TABLET;ORAL~AZITHROMYCIN~WOCKHARDT~EQ 250MG BASE~A~065404~001~AB~Fe
b 11, 2008~No~RX~WOCKHARDT LTD
PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE~TABLET;ORAL~AZO GANTANOL~ROCHE~1
00MG;500MG **Federal Register determination that product was not discontinued or
withdrawn for safety or efficacy reasons**~N~013294~001~~Sep 10, 1987~No~DISCN~
PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE~TABLET;ORAL~AZO GANTRISIN~ROCHE~50M
G;500MG **Federal Register determination that product was not discontinued or wi
thdrawn for safety or efficacy reasons**~N~019358~001~~Aug 31, 1990~No~DISCN~HOF
FMANN LA ROCHE INC
PHENYLBUTAZONE~TABLET;ORAL~AZOLID~SANOFI AVENTIS US~100MG~A~087091~001~~Approved
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL~TABLET;ORAL~AZOR~DAIICHI SANKYO~EQ 5MG
BASE;20MG~N~022100~001~~Sep 26, 2007~No~RX~DAIICHI SANKYO INC
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL~TABLET;ORAL~AZOR~DAIICHI SANKYO~EQ 5MG
BASE;40MG~N~022100~002~~Sep 26, 2007~No~RX~DAIICHI SANKYO INC
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL~TABLET;ORAL~AZOR~DAIICHI SANKYO~EQ 10M
G BASE;20MG~N~022100~003~~Sep 26, 2007~No~RX~DAIICHI SANKYO INC
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL~TABLET;ORAL~AZOR~DAIICHI SANKYO~EQ 10M
G BASE;40MG~N~022100~004~~Sep 26, 2007~Yes~RX~DAIICHI SANKYO INC
SULFASALAZINE~TABLET;ORAL~AZULFIDINE~PHARMACIA AND UPJOHN~500MG~N~007073~001~AB~
Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
BACLOFEN~TABLET;ORAL~BACLOFEN~CARACO~10MG~A~077984~001~AB~Aug 14, 2006~No~RX~CAR
ACO PHARMACEUTICAL LABORATORIES LTD
BACLOFEN~TABLET;ORAL~BACLOFEN~IMPAX LABS~10MG~A~078146~001~AB~Oct 26, 2007~No~RX
BACLOFEN~TABLET;ORAL~BACLOFEN~IMPAX LABS~20MG~A~077971~002~AB~Oct 26, 2007~No~RX
BACLOFEN~TABLET;ORAL~BACLOFEN~IVAX SUB TEVA PHARMS~10MG~A~072234~001~AB~Jul 21,
1988~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
BACLOFEN~TABLET;ORAL~BACLOFEN~IVAX SUB TEVA PHARMS~20MG~A~072235~001~AB~Jul 21,
1988~Yes~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
BACLOFEN~TABLET;ORAL~BACLOFEN~LANNETT~10MG~A~078220~001~AB~Jul 6, 2007~No~RX~LAN
NETT HOLDINGS INC
BACLOFEN~TABLET;ORAL~BACLOFEN~LANNETT~20MG~A~077241~001~AB~Dec 20, 2005~No~RX~LA
NNETT HOLDINGS INC

BACLOFEN~TABLET;ORAL~BACLOFEN~MYLAN~10MG~A~077181~001~AB~Jul 29, 2005~No~RX~MYLA
BACLOFEN~TABLET;ORAL~BACLOFEN~MYLAN~20MG~A~077121~002~AB~Jul 29, 2005~No~RX~MYLA
BACLOFEN~TABLET;ORAL~BACLOFEN~MYLAN PHARMS INC~10MG~A~090334~001~AB~Feb 18, 2010
BACLOFEN~TABLET;ORAL~BACLOFEN~MYLAN PHARMS INC~20MG~A~090334~002~AB~Feb 18, 2010
BACLOFEN~TABLET;ORAL~BACLOFEN~NORTHSTAR HLTHCARE~10MG~A~078504~001~AB~Sep 18, 20
BACLOFEN~TABLET;ORAL~BACLOFEN~NORTHSTAR HLTHCARE~20MG~A~078401~001~AB~Sep 18, 20
BACLOFEN~TABLET;ORAL~BACLOFEN~PROSAM LABS~10MG~A~077089~001~AB~Oct 31, 2007~No~R
X~PROSAM LABS LLC
BACLOFEN~TABLET;ORAL~BACLOFEN~PROSAM LABS~20MG~A~077088~001~AB~Oct 31, 2007~No~R
X~PROSAM LABS LLC
BACLOFEN~TABLET;ORAL~BACLOFEN~SUN PHARM INDS INC~20MG~A~077862~002~AB~Aug 14, 20
BACLOFEN~TABLET;ORAL~BACLOFEN~TEVA~10MG~A~073043~001~~Feb 27, 1992~No~DISCN~TEVA
BACLOFEN~TABLET;ORAL~BACLOFEN~TEVA~20MG~A~073044~001~~Feb 27, 1992~No~DISCN~TEVA
BACLOFEN~TABLET;ORAL~BACLOFEN~USL PHARMA~10MG~A~071260~001~~May 6, 1988~No~DISCN
~USL PHARMA INC
BACLOFEN~TABLET;ORAL~BACLOFEN~USL PHARMA~10MG~A~074584~001~AB~Aug 19, 1996~No~RX
~USL PHARMA INC
BACLOFEN~TABLET;ORAL~BACLOFEN~USL PHARMA~20MG~A~071261~001~~May 6, 1988~No~DISCN
~USL PHARMA INC
BACLOFEN~TABLET;ORAL~BACLOFEN~USL PHARMA~20MG~A~074584~002~AB~Aug 19, 1996~No~RX
~USL PHARMA INC
BACLOFEN~TABLET;ORAL~BACLOFEN~VINTAGE PHARMS~10MG~A~077156~001~AB~Aug 30, 2005~N
o~RX~VINTAGE PHARMACEUTICALS INC
BACLOFEN~TABLET;ORAL~BACLOFEN~VINTAGE PHARMS~20MG~A~077068~001~AB~Aug 30, 2005~N
BACLOFEN~TABLET;ORAL~BACLOFEN~WATSON LABS~10MG~A~072824~001~AB~Sep 18, 1991~No~R
BACLOFEN~TABLET;ORAL~BACLOFEN~WATSON LABS~10MG~A~073092~001~~Jan 28, 1994~No~DIS
BACLOFEN~TABLET;ORAL~BACLOFEN~WATSON LABS~10MG~A~074698~001~~Aug 20, 1996~No~DIS
BACLOFEN~TABLET;ORAL~BACLOFEN~WATSON LABS~20MG~A~072825~001~AB~Sep 18, 1991~No~R
BACLOFEN~TABLET;ORAL~BACLOFEN~WATSON LABS~20MG~A~073093~001~~Jan 28, 1994~No~DIS
BACLOFEN~TABLET;ORAL~BACLOFEN~WATSON LABS~20MG~A~074698~002~~Aug 20, 1996~No~DIS
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~BACTRIM~MUTUAL PHARM~400MG;80MG~N~017
377~001~AB~Approved Prior to Jan 1, 1982~No~RX~MUTUAL PHARMACEUTICAL CO INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~BACTRIM DS~MUTUAL PHARM~800MG;160MG~N
~017377~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~MUTUAL PHARMACEUTICAL CO INC
MEPROBAMATE~TABLET;ORAL~BAMATE~ALRA~200MG~A~080380~001~~Approved Prior to Jan 1,
1982~No~DISCN~ALRA LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~BAMATE~ALRA~400MG~A~080380~002~~Approved Prior to Jan 1,
1982~No~DISCN~ALRA LABORATORIES INC
CEFPODOXIME PROXETIL~TABLET;ORAL~BANAN~SANKYO~EQ 100MG BASE~N~050687~001~~Aug 7,
1992~No~DISCN~SANKYO USA CORP
CEFPODOXIME PROXETIL~TABLET;ORAL~BANAN~SANKYO~EQ 200MG BASE~N~050687~002~~Aug 7,
1992~No~DISCN~SANKYO USA CORP
METHANTHELINE BROMIDE~TABLET;ORAL~BANTHINE~SHIRE~50MG~N~007390~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC

RUFINAMIDE~TABLET;ORAL~BANZEL~EISAI INC~100MG **Federal Register determination t
hat product was not discontinued or withdrawn for safety or efficacy reasons**~N
~021911~001~~Nov 14, 2008~No~DISCN~EISAI INC
RUFINAMIDE~TABLET;ORAL~BANZEL~EISAI INC~200MG~N~021911~002~~Nov 14, 2008~No~RX~E
ISAI INC
RUFINAMIDE~TABLET;ORAL~BANZEL~EISAI INC~400MG~N~021911~003~~Nov 14, 2008~Yes~RX~
EISAI INC
ENTECAVIR~TABLET;ORAL~BARACLUDE~BRISTOL MYERS SQUIBB~0.5MG~N~021797~001~AB~Mar 2
9, 2005~No~RX~BRISTOL MYERS SQUIBB
ENTECAVIR~TABLET;ORAL~BARACLUDE~BRISTOL MYERS SQUIBB~1MG~N~021797~002~AB~Mar 29,
2005~Yes~RX~BRISTOL MYERS SQUIBB
CERIVASTATIN SODIUM~TABLET;ORAL~BAYCOL~BAYER PHARMS~0.05MG~N~020740~001~~Jun 26,
CERIVASTATIN SODIUM~TABLET;ORAL~BAYCOL~BAYER PHARMS~0.4MG~N~020740~005~~May 24,
CERIVASTATIN SODIUM~TABLET;ORAL~BAYCOL~BAYER PHARMS~0.8MG~N~020740~006~~Jul 24,
ASPIRIN~TABLET;ORAL~BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN~BAYER~500MG~N
~021317~001~~Oct 18, 2001~No~DISCN~BAYER HEALTHCARE LLC
PENICILLIN V POTASSIUM~TABLET;ORAL~BEEPEN-VK~GLAXOSMITHKLINE~EQ 250MG BASE~A~062
PENICILLIN V POTASSIUM~TABLET;ORAL~BEEPEN-VK~GLAXOSMITHKLINE~EQ 500MG BASE~A~062
SUVOREXANT~TABLET;ORAL~BELSOMRA~MERCK SHARP DOHME~5MG~N~204569~001~~Aug 13, 2014
~No~RX~MERCK SHARP AND DOHME CORP
LORCASERIN HYDROCHLORIDE~TABLET;ORAL~BELVIQ~EISAI INC~10MG~N~022529~001~~Jun 27,
2012~Yes~RX~EISAI INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~ACTAVIS LABS FL IN
C~5MG~A~076267~001~AB~Feb 11, 2004~No~RX~ACTAVIS LABORATORIES FL INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~AMNEAL PHARMS LLC~
5MG~A~076820~001~AB~Feb 3, 2006~No~RX~AMNEAL PHARMACEUTICALS LLC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~APOTEX INC~5MG~A~0
77128~001~AB~Mar 8, 2006~No~RX~APOTEX INC ETOBICOKE SITE
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~APOTEX INC~10MG~A~

BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~AUROBINDO PHARMA~1
0MG~A~078212~001~AB~May 22, 2008~No~RX~AUROBINDO PHARMA LTD
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~GENPHARM~5MG~A~076
476~001~~Feb 11, 2004~No~DISCN~GENPHARM INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~5MG~A~076333~001~AB~Feb 11, 2004~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHAR
MACEUTICALS USA
MS~10MG~A~076333~002~AB~Feb 11, 2004~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHA
RMACEUTICALS USA
RMACEUTICALS USA
RMACEUTICALS USA
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~MYLAN~5MG~A~076430
~001~AB~Feb 11, 2004~No~RX~MYLAN PHARMACEUTICALS INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~PRINSTON INC~5MG~A
~076118~001~AB~Feb 11, 2004~No~RX~PRINSTON PHARMACEUTICAL INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~PRINSTON INC~10MG~
A~076118~002~AB~Feb 11, 2004~No~RX~PRINSTON PHARMACEUTICAL INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~RANBAXY~5MG~A~0763
44~001~AB~Feb 11, 2004~No~RX~RANBAXY LABORATORIES LTD
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~SANDOZ~5MG~A~07640
2~001~AB~Feb 11, 2004~No~RX~SANDOZ INC

BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~TEVA~5MG~A~076211~
001~AB~Feb 11, 2004~No~RX~TEVA PHARMACEUTICALS USA INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~TEVA~10MG~A~076211
~002~AB~Feb 11, 2004~No~RX~TEVA PHARMACEUTICALS USA INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORIDE~ZYDUS PHARMS USA~5
MG~A~078848~001~AB~May 23, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
0MG~A~078848~002~AB~May 23, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~BENAZEPRIL HYDROCHLORI
DE AND HYDROCHLOROTHIAZIDE~ACTAVIS LABS FL INC~5MG;6.25MG~A~076342~001~AB~Feb 11
, 2004~No~RX~ACTAVIS LABORATORIES FL INC
DE AND HYDROCHLOROTHIAZIDE~ACTAVIS LABS FL INC~20MG;25MG~A~076342~004~AB~Feb 11,
2004~No~RX~ACTAVIS LABORATORIES FL INC
DE AND HYDROCHLOROTHIAZIDE~APOTEX INC~5MG;6.25MG~A~078794~001~AB~Aug 21, 2014~No
~RX~APOTEX INC
DE AND HYDROCHLOROTHIAZIDE~APOTEX INC~10MG;12.5MG~A~078794~002~AB~Aug 21, 2014~N
o~RX~APOTEX INC
DE AND HYDROCHLOROTHIAZIDE~APOTEX INC~20MG;12.5MG~A~078794~003~AB~Aug 21, 2014~N
o~RX~APOTEX INC
DE AND HYDROCHLOROTHIAZIDE~APOTEX INC~20MG;25MG~A~078794~004~AB~Aug 21, 2014~No~
RX~APOTEX INC
DE AND HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~5MG;6.25MG~A~076348~001~AB~Feb 1
1, 2004~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
DE AND HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~10MG;12.5MG~A~076348~002~AB~Feb
DE AND HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~20MG;12.5MG~A~076348~003~AB~Feb
DE AND HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~20MG;25MG~A~076348~004~AB~Feb 11
, 2004~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
DE AND HYDROCHLOROTHIAZIDE~MYLAN~5MG;6.25MG~A~076688~001~AB~Feb 11, 2004~No~RX~M
DE AND HYDROCHLOROTHIAZIDE~MYLAN~10MG;12.5MG~A~076688~002~AB~Feb 11, 2004~No~RX~

DE AND HYDROCHLOROTHIAZIDE~MYLAN~20MG;12.5MG~A~076688~003~AB~Feb 11, 2004~No~RX~
DE AND HYDROCHLOROTHIAZIDE~MYLAN~20MG;25MG~A~076688~004~AB~Feb 11, 2004~No~RX~MY
DE AND HYDROCHLOROTHIAZIDE~MYLAN PHARMS INC~5MG;6.25MG~A~076612~001~~Feb 11, 200
DE AND HYDROCHLOROTHIAZIDE~MYLAN PHARMS INC~20MG;25MG~A~076612~004~~Feb 11, 2004
~No~DISCN~MYLAN PHARMACEUTICALS INC
DE AND HYDROCHLOROTHIAZIDE~RANBAXY~5MG;6.25MG~A~077483~001~AB~Sep 8, 2005~No~RX~
RANBAXY LABORATORIES LTD
DE AND HYDROCHLOROTHIAZIDE~RANBAXY~10MG;12.5MG~A~077483~002~AB~Sep 8, 2005~No~RX
DE AND HYDROCHLOROTHIAZIDE~RANBAXY~20MG;12.5MG~A~077483~003~AB~Sep 8, 2005~No~RX
DE AND HYDROCHLOROTHIAZIDE~RANBAXY~20MG;25MG~A~077483~004~AB~Sep 8, 2005~No~RX~R
ANBAXY LABORATORIES LTD
DE AND HYDROCHLOROTHIAZIDE~SANDOZ~5MG;6.25MG~A~076631~001~AB~Feb 11, 2004~No~RX~
SANDOZ INC
DE AND HYDROCHLOROTHIAZIDE~SANDOZ~10MG;12.5MG~A~076631~002~AB~Feb 11, 2004~No~RX
~SANDOZ INC
DE AND HYDROCHLOROTHIAZIDE~SANDOZ~20MG;12.5MG~A~076631~003~AB~Feb 11, 2004~No~RX
~SANDOZ INC
DE AND HYDROCHLOROTHIAZIDE~SANDOZ~20MG;25MG~A~076631~004~AB~Feb 11, 2004~No~RX~S
ANDOZ INC
PROBENECID~TABLET;ORAL~BENEMID~MERCK~500MG~N~007898~004~~Approved Prior to Jan 1
, 1982~No~DISCN~MERCK AND CO INC
OLMESARTAN MEDOXOMIL~TABLET;ORAL~BENICAR~DAIICHI SANKYO~5MG~N~021286~001~~Apr 25
, 2002~No~RX~DAIICHI SANKYO INC
5, 2002~No~RX~DAIICHI SANKYO INC
5, 2002~Yes~RX~DAIICHI SANKYO INC
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL~TABLET;ORAL~BENICAR HCT~DAIICHI SANKYO
~12.5MG;20MG~N~021532~002~~Jun 5, 2003~No~RX~DAIICHI SANKYO INC
~12.5MG;40MG~N~021532~003~~Jun 5, 2003~No~RX~DAIICHI SANKYO INC
~25MG;40MG~N~021532~005~~Jun 5, 2003~Yes~RX~DAIICHI SANKYO INC
DICYCLOMINE HYDROCHLORIDE~TABLET;ORAL~BENTYL~FOREST LABS INC~20MG~N~007409~001~A
B~Oct 15, 1984~Yes~RX~FOREST LABORATORIES INC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~COREPHARMA~5
0MG~A~040714~001~~Oct 29, 2007~No~DISCN~COREPHARMA LLC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~EMCURE PHARM

S LTD~50MG~A~202061~001~AA~Jan 27, 2012~No~RX~EMCURE PHARMACEUTICALS LTD
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~IMPAX LABS~5
0MG~A~040845~001~AA~Nov 18, 2008~No~RX~IMPAX LABORATORIES INC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~KVK TECH~50M
G~A~090968~001~AA~Jul 20, 2010~No~RX~KVK TECH INC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~MALLINCKRODT
INC~50MG~A~040773~001~AA~Apr 25, 2007~No~RX~MALLINCKRODT INC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~MIKART~25MG~
A~090473~001~AA~Sep 15, 2010~No~RX~MIKART INC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~MIKART~50MG~
A~090473~002~AA~Sep 15, 2010~No~RX~MIKART INC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~PADDOCK~50MG
~A~040578~001~AA~Apr 17, 2006~No~RX~PADDOCK LABORATORIES INC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~BENZPHETAMINE HYDROCHLORIDE~TEDOR PHARM~
50MG~A~040747~001~AA~Mar 30, 2007~No~RX~TEDOR PHARMA INC
BENZTHIAZIDE~TABLET;ORAL~BENZTHIAZIDE~PVT FORM~50MG~A~083206~001~~Approved Prior
to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~COREPHARMA~0.5MG~A~072264~
001~AA~Feb 27, 1989~No~RX~COREPHARMA LLC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~COREPHARMA~1MG~A~072265~00
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~COREPHARMA~2MG~A~072266~00
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~EXCELLIUM~0.5MG~A~090168~0
01~AA~Nov 28, 2012~No~RX~EXCELLIUM PHARMACEUTICAL INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~EXCELLIUM~1MG~A~090168~002
~AA~Nov 28, 2012~No~RX~EXCELLIUM PHARMACEUTICAL INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~EXCELLIUM~2MG~A~090168~003
~AA~Nov 28, 2012~No~RX~EXCELLIUM PHARMACEUTICAL INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~INVAGEN PHARMS~0.5MG~A~090
294~001~AA~Mar 29, 2010~No~RX~INVAGEN PHARMACEUTICALS INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~INVAGEN PHARMS~1MG~A~09029
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~INVAGEN PHARMS~2MG~A~09029
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~LANNETT HOLDINGS INC~0.5MG
~A~088877~001~~Apr 11, 1985~No~DISCN~LANNETT HOLDINGS INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~LANNETT HOLDINGS INC~1MG~A
~088894~001~~Apr 11, 1985~No~DISCN~LANNETT HOLDINGS INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~LANNETT HOLDINGS INC~2MG~A
~088895~001~~Apr 11, 1985~No~DISCN~LANNETT HOLDINGS INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~MUTUAL PHARM~1MG~A~081264~
001~~Jan 23, 1992~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~MUTUAL PHARM~2MG~A~081265~
001~~Jan 23, 1992~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~PLIVA~0.5MG~A~089058~001~A
A~Aug 10, 1988~No~RX~PLIVA INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~PLIVA~1MG~A~089059~001~AA~
Aug 10, 1988~No~RX~PLIVA INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~PLIVA~2MG~A~089060~001~AA~
Aug 10, 1988~No~RX~PLIVA INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~PROSAM LABS~0.5MG~A~040699
~001~~Feb 14, 2008~No~DISCN~PROSAM LABS LLC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~PROSAM LABS~1MG~A~040705~0
01~~Feb 14, 2008~No~DISCN~PROSAM LABS LLC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~PROSAM LABS~2MG~A~040706~0
01~~Feb 14, 2008~No~DISCN~PROSAM LABS LLC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~QUANTUM PHARMICS~0.5MG~A~0
88514~001~~Jan 31, 1984~No~DISCN~QUANTUM PHARMICS LTD
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~QUANTUM PHARMICS~1MG~A~088

BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~QUANTUM PHARMICS~2MG~A~088
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~USL PHARMA~0.5MG~A~040103~
001~AA~Dec 12, 1996~Yes~RX~USL PHARMA INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~USL PHARMA~0.5MG~A~089211~
001~~Jun 14, 1988~No~DISCN~USL PHARMA INC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~USL PHARMA~1MG~A~040103~00
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~VINTAGE~0.5MG~A~040738~001
~AA~Aug 27, 2007~No~RX~VINTAGE PHARMACEUTICALS LLC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~VINTAGE~1MG~A~040742~001~A
A~Aug 27, 2007~No~RX~VINTAGE PHARMACEUTICALS LLC
BENZTROPINE MESYLATE~TABLET;ORAL~BENZTROPINE MESYLATE~VINTAGE~2MG~A~040715~003~A
A~Aug 27, 2007~No~RX~VINTAGE PHARMACEUTICALS LLC
BEPRIDIL HYDROCHLORIDE~TABLET;ORAL~BEPADIN~MEDPOINTE PHARM HLC~200MG~N~019001~00
1~~Dec 28, 1990~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~BETAPACE~BAYER HLTHCARE~80MG~N~019865~001~AB1~
Oct 30, 1992~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~BETAPACE~BAYER HLTHCARE~120MG~N~019865~005~AB1
~Apr 20, 1994~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
~Oct 30, 1992~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
~Oct 30, 1992~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~BETAPACE~BAYER HLTHCARE~320MG~N~019865~004~~Oc
t 30, 1992~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~BETAPACE AF~COVIS PHARMA SARL~40MG~N~021151~00
6~~Apr 2, 2003~No~DISCN~COVIS PHARMA SARL
7~~Apr 2, 2003~No~DISCN~COVIS PHARMA SARL
1~AB2~Feb 22, 2000~No~RX~COVIS PHARMA SARL
05~~Mar 14, 2003~No~DISCN~COVIS PHARMA SARL
02~AB2~Feb 22, 2000~No~RX~COVIS PHARMA SARL
03~AB2~Feb 22, 2000~Yes~RX~COVIS PHARMA SARL
MEPREDNISONE~TABLET;ORAL~BETAPAR~SCHERING~4MG~N~016053~002~~Approved Prior to Ja
PENICILLIN V POTASSIUM~TABLET;ORAL~BETAPEN-VK~BRISTOL~EQ 250MG BASE~A~061150~001
ERS CO
PENICILLIN V POTASSIUM~TABLET;ORAL~BETAPEN-VK~BRISTOL~EQ 500MG BASE~A~061150~002
ERS CO
BETAXOLOL HYDROCHLORIDE~TABLET;ORAL~BETAXOLOL HYDROCHLORIDE~EPIC PHARMA~10MG~A~0
75541~001~AB~Oct 22, 1999~No~RX~EPIC PHARMA LLC
BETAXOLOL HYDROCHLORIDE~TABLET;ORAL~BETAXOLOL HYDROCHLORIDE~EPIC PHARMA~20MG~A~0

75541~002~AB~Oct 22, 1999~Yes~RX~EPIC PHARMA LLC
BETAXOLOL HYDROCHLORIDE~TABLET;ORAL~BETAXOLOL HYDROCHLORIDE~KVK TECH~10MG~A~0789
62~001~AB~Jun 27, 2008~No~RX~KVK TECH INC
BETAXOLOL HYDROCHLORIDE~TABLET;ORAL~BETAXOLOL HYDROCHLORIDE~KVK TECH~20MG~A~0789
62~002~AB~Jun 27, 2008~No~RX~KVK TECH INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~ABLE~5MG~A~040492~001~~Jul
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~ABLE~10MG~A~040483~001~~Ju
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~ACTAVIS ELIZABETH~5MG~A~04
0552~001~~Oct 28, 2004~No~DISCN~ACTAVIS ELIZABETH LLC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~AMNEAL PHARM~5MG~A~040855~
001~AA~Nov 21, 2007~No~RX~AMNEAL PHARMACEUTICAL
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~AMNEAL PHARM~10MG~A~040855
~002~AA~Nov 21, 2007~No~RX~AMNEAL PHARMACEUTICAL
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~ASCOT~10MG~A~088288~001~~J
un 8, 1983~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~ASCOT~25MG~A~088289~001~~J
un 8, 1983~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~EMCURE USA~5MG~A~091256~00
1~AA~May 4, 2010~No~RX~EMCURE PHARMACEUTICALS USA INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~IMPAX LABS~5MG~A~040739~00
1~AA~Nov 1, 2006~No~RX~IMPAX LABORATORIES INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~IVAX SUB TEVA PHARMS~25MG~
A~084689~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SU
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~LANNETT~5MG~A~084702~001~~
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~LANNETT~10MG~A~040704~001~
AA~Mar 27, 2008~No~RX~LANNETT HOLDINGS INC

BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~LANNETT HOLDINGS INC~5MG~A
~040703~001~AA~Mar 27, 2008~No~RX~LANNETT HOLDINGS INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~LANNETT HOLDINGS INC~50MG~
A~040677~001~AA~Mar 27, 2008~No~RX~LANNETT HOLDINGS INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~PHARMAX~5MG~A~040725~001~A
A~Oct 26, 2007~No~RX~PHARMAX GROUP INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~PHARMAX~10MG~A~040726~001~
AA~Oct 26, 2007~No~RX~PHARMAX GROUP INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~SANDOZ~5MG~A~084353~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~SANDOZ~10MG~A~084378~001~~
Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~SUN PHARM INDS INC~5MG~A~0
40897~001~AA~Apr 22, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~SUN PHARM INDS INC~10MG~A~
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~UPSHER SMITH~5MG~A~040633~
001~AA~Jun 1, 2005~No~RX~UPSHER SMITH LABORATORIES INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~UPSHER SMITH~10MG~A~040634
~001~AA~Jun 1, 2005~No~RX~UPSHER SMITH LABORATORIES INC
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~WATSON LABS~5MG~A~084402~0
BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~WATSON LABS~10MG~A~084408~

BETHANECHOL CHLORIDE~TABLET;ORAL~BETHANECHOL CHLORIDE~WOCKHARDT~5MG~A~040532~001
~AA~Sep 29, 2003~No~RX~WOCKHARDT LTD
1~AA~Sep 29, 2003~No~RX~WOCKHARDT LTD
VALDECOXIB~TABLET;ORAL~BEXTRA~GD SEARLE~10MG~N~021341~002~~Nov 16, 2001~No~DISCN
~GD SEARLE LLC
VALDECOXIB~TABLET;ORAL~BEXTRA~GD SEARLE~20MG~N~021341~003~~Nov 16, 2001~No~DISCN
~GD SEARLE LLC
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM~TABLET;ORAL~BEYAZ~BAYER HL
THCARE~3MG,N/A;0.02MG,N/A;0.451MG,0.451MG~N~022532~001~~Sep 24, 2010~No~RX~BAYER
HEALTHCARE PHARMACEUTICALS INC
CLARITHROMYCIN~TABLET;ORAL~BIAXIN~ABBVIE~250MG~N~050662~001~AB~Oct 31, 1991~Yes~
RX~ABBVIE INC
CLARITHROMYCIN~TABLET;ORAL~BIAXIN~ABBVIE~500MG~N~050662~002~AB~Oct 31, 1991~Yes~
RX~ABBVIE INC
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~ACCORD HLTHCARE~50MG~A~078917~001~AB~Jul 6
, 2009~No~RX~ACCORD HEALTHCARE INC
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~ACTAVIS TOTOWA~50MG~A~078634~001~AB~Aug 28
, 2009~No~RX~ACTAVIS TOTOWA LLC
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~FRESENIUS KABI ONCOL~50MG~A~079045~001~AB~
May 13, 2010~No~RX~FRESENIUS KABI ONCOLOGY PLC
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~KUDCO IRELAND~50MG~A~077995~001~~Jul 6, 20
09~No~DISCN~KUDCO IRELAND LTD
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~MYLAN~50MG~A~079185~001~AB~Jul 6, 2009~No~
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~ROXANE~50MG~A~078285~001~~Mar 24, 2011~No~
DISCN~ROXANE LABORATORIES INC
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~SANDOZ~50MG~A~078575~001~AB~Jul 6, 2009~No
~RX~SANDOZ INC
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~SUN PHARMA GLOBAL~50MG~A~079110~001~AB~Jul
6, 2009~No~RX~SUN PHARMA GLOBAL INC
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~SYNTHON PHARMS~50MG~A~077973~001~~Jul 6, 2
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~TEVA~50MG~A~076932~001~AB~Jul 6, 2009~No~R
BICALUTAMIDE~TABLET;ORAL~BICALUTAMIDE~ZYDUS PHARMS USA INC~50MG~A~079089~001~AB~
Jul 6, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
PENICILLIN G BENZATHINE~TABLET;ORAL~BICILLIN~WYETH AYERST~200,000 UNITS~N~050128
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE~TABLET;ORAL~BIDIL~ARBOR PHARMS L
LC~37.5MG;20MG~N~020727~001~~Jun 23, 2005~Yes~RX~ARBOR PHARMACEUTICALS LLC
PRAZIQUANTEL~TABLET;ORAL~BILTRICIDE~BAYER HLTHCARE~600MG~N~018714~001~~Dec 29, 1
982~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~AUROBINDO PHARMA~5MG~A~07791
0~001~AB~Dec 27, 2006~No~RX~AUROBINDO PHARMA LTD
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~AUROBINDO PHARMA~10MG~A~0779
10~002~AB~Dec 27, 2006~No~RX~AUROBINDO PHARMA LTD
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~MUTUAL PHARM~5MG~A~075474~00
1~~Oct 25, 2002~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~MUTUAL PHARM~10MG~A~075474~0
02~~Oct 25, 2002~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~MYLAN~5MG~A~075831~001~AB~De
c 14, 2005~No~RX~MYLAN PHARMACEUTICALS INC
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~MYLAN~10MG~A~075831~002~AB~D

ec 14, 2005~No~RX~MYLAN PHARMACEUTICALS INC
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~SANDOZ~5MG~A~075643~001~AB~N
ov 16, 2000~No~RX~SANDOZ INC
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~SANDOZ~10MG~A~075643~002~AB~
Nov 16, 2000~No~RX~SANDOZ INC
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~TEVA PHARMS~5MG~A~075644~001
~AB~Jun 26, 2001~No~RX~TEVA PHARMACEUTICALS USA
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~TEVA PHARMS~10MG~A~075644~00
2~AB~Jun 26, 2001~No~RX~TEVA PHARMACEUTICALS USA
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~UNICHEM PHARMS (USA)~5MG~A~0
78635~001~AB~Aug 18, 2009~No~RX~UNICHEM PHARMACEUTICALS (USA) INC
BISOPROLOL FUMARATE~TABLET;ORAL~BISOPROLOL FUMARATE~UNICHEM PHARMS (USA)~10MG~A~
078635~002~AB~Aug 18, 2009~No~RX~UNICHEM PHARMACEUTICALS (USA) INC
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~BISOPROLOL FUMARATE AND HYD
ROCHLOROTHIAZIDE~ACTAVIS ELIZABETH~2.5MG;6.25MG~A~075672~001~~Sep 25, 2000~No~DI
SCN~ACTAVIS ELIZABETH LLC
ROCHLOROTHIAZIDE~ACTAVIS ELIZABETH~5MG;6.25MG~A~075672~002~~Sep 25, 2000~No~DISC
N~ACTAVIS ELIZABETH LLC
ROCHLOROTHIAZIDE~ACTAVIS ELIZABETH~10MG;6.25MG~A~075672~003~~Sep 25, 2000~No~DIS
CN~ACTAVIS ELIZABETH LLC
ROCHLOROTHIAZIDE~APOTHECON~2.5MG;6.25MG~A~075642~002~~Dec 27, 2000~No~DISCN~APOT
HECON INC DIV BRISTOL MYERS SQUIBB
ROCHLOROTHIAZIDE~APOTHECON~5MG;6.25MG~A~075642~001~~Dec 27, 2000~No~DISCN~APOTHE
CON INC DIV BRISTOL MYERS SQUIBB
ROCHLOROTHIAZIDE~APOTHECON~10MG;6.25MG~A~075642~003~~Dec 27, 2000~No~DISCN~APOTH
ECON INC DIV BRISTOL MYERS SQUIBB
ROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~2.5MG;6.25MG~A~075632~001~~Sep 27, 2000~No
~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~5MG;6.25MG~A~075632~002~~Sep 27, 2000~No~D
ISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~10MG;6.25MG~A~075632~003~~Sep 27, 2000~No~
DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ROCHLOROTHIAZIDE~MYLAN~2.5MG;6.25MG~A~075768~001~AB~Sep 25, 2000~No~RX~MYLAN PHA
RMACEUTICALS INC
ROCHLOROTHIAZIDE~MYLAN~5MG;6.25MG~A~075768~002~AB~Sep 25, 2000~No~RX~MYLAN PHARM
ACEUTICALS INC
ROCHLOROTHIAZIDE~MYLAN~10MG;6.25MG~A~075768~003~AB~Sep 25, 2000~No~RX~MYLAN PHAR
MACEUTICALS INC
ROCHLOROTHIAZIDE~SANDOZ~2.5MG;6.25MG~A~075527~001~~Sep 25, 2000~No~DISCN~SANDOZ
INC
ROCHLOROTHIAZIDE~SANDOZ~2.5MG;6.25MG~A~075579~001~AB~Sep 25, 2000~No~RX~SANDOZ I
NC
ROCHLOROTHIAZIDE~SANDOZ~5MG;6.25MG~A~075527~003~~Sep 25, 2000~No~DISCN~SANDOZ IN
C
ROCHLOROTHIAZIDE~SANDOZ~5MG;6.25MG~A~075579~002~AB~Sep 25, 2000~No~RX~SANDOZ INC

ROCHLOROTHIAZIDE~SANDOZ~10MG;6.25MG~A~075527~002~~Sep 25, 2000~No~DISCN~SANDOZ I
NC
ROCHLOROTHIAZIDE~SANDOZ~10MG;6.25MG~A~075579~003~AB~Sep 25, 2000~No~RX~SANDOZ IN
C
ROCHLOROTHIAZIDE~TEVA~2.5MG;6.25MG~A~075686~001~~Jan 19, 2001~No~DISCN~TEVA PHAR
MACEUTICALS USA INC
ROCHLOROTHIAZIDE~TEVA~5MG;6.25MG~A~075686~002~~Jan 19, 2001~No~DISCN~TEVA PHARMA
CEUTICALS USA INC
ROCHLOROTHIAZIDE~TEVA~10MG;6.25MG~A~075686~003~~Jan 19, 2001~No~DISCN~TEVA PHARM
ACEUTICALS USA INC
ROCHLOROTHIAZIDE~UNICHEM~2.5MG;6.25MG~A~079106~001~AB~Jul 28, 2010~No~RX~UNICHEM
LABORATORIES LTD
ROCHLOROTHIAZIDE~UNICHEM~5MG;6.25MG~A~079106~002~AB~Jul 28, 2010~No~RX~UNICHEM L
ABORATORIES LTD
ROCHLOROTHIAZIDE~UNICHEM~10MG;6.25MG~A~079106~003~AB~Jul 28, 2010~No~RX~UNICHEM
LABORATORIES LTD
ROCHLOROTHIAZIDE~WATSON LABS~2.5MG;6.25MG~A~075469~001~~Sep 25, 2000~No~DISCN~WA
ROCHLOROTHIAZIDE~WATSON LABS~5MG;6.25MG~A~075469~002~~Sep 25, 2000~No~DISCN~WATS
ON LABORATORIES INC
ROCHLOROTHIAZIDE~WATSON LABS~10MG;6.25MG~A~075469~003~~Sep 25, 2000~No~DISCN~WAT
SON LABORATORIES INC
TIMOLOL MALEATE~TABLET;ORAL~BLOCADREN~MERCK~5MG~N~018017~001~~Approved Prior to
Jan 1, 1982~No~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
IBANDRONATE SODIUM~TABLET;ORAL~BONIVA~HOFFMANN LA ROCHE~EQ 2.5MG BASE **Federal
or efficacy reasons**~N~021455~001~~May 16, 2003~No~DISCN~HOFFMANN LA ROCHE INC
IBANDRONATE SODIUM~TABLET;ORAL~BONIVA~HOFFMANN LA ROCHE~EQ 150MG BASE~N~021455~0
02~AB~Mar 24, 2005~Yes~RX~HOFFMANN LA ROCHE INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~BONTRIL PDM~VALEANT~35MG~A~085272~001~AA~Ap
proved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
BOSUTINIB MONOHYDRATE~TABLET;ORAL~BOSULIF~WYETH PHARMS INC~EQ 100MG BASE~N~20334
1~001~~Sep 4, 2012~No~RX~WYETH PHARMACEUTICALS INC
BOSUTINIB MONOHYDRATE~TABLET;ORAL~BOSULIF~WYETH PHARMS INC~EQ 500MG BASE~N~20334
1~002~~Sep 4, 2012~Yes~RX~WYETH PHARMACEUTICALS INC
TERBUTALINE SULFATE~TABLET;ORAL~BRETHINE~LEHIGH VALLEY~2.5MG~N~017849~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~LEHIGH VALLEY TECHNOLOGIES INC
TERBUTALINE SULFATE~TABLET;ORAL~BRETHINE~LEHIGH VALLEY~5MG~N~017849~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~LEHIGH VALLEY TECHNOLOGIES INC
TERBUTALINE SULFATE~TABLET;ORAL~BRICANYL~SANOFI AVENTIS US~2.5MG~N~017618~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
TERBUTALINE SULFATE~TABLET;ORAL~BRICANYL~SANOFI AVENTIS US~5MG~N~017618~002~~App
TICAGRELOR~TABLET;ORAL~BRILINTA~ASTRAZENECA LP~90MG~N~022433~001~~Jul 20, 2011~Y
es~RX~ASTRAZENECA LP
VORTIOXETINE HYDROBROMIDE~TABLET;ORAL~BRINTELLIX~TAKEDA PHARMS USA~EQ 5MG BASE~N
~204447~001~~Sep 30, 2013~No~RX~TAKEDA PHARMACEUTICALS USA INC
VORTIOXETINE HYDROBROMIDE~TABLET;ORAL~BRINTELLIX~TAKEDA PHARMS USA~EQ 10MG BASE~
N~204447~002~~Sep 30, 2013~No~RX~TAKEDA PHARMACEUTICALS USA INC
N~204447~003~~Sep 30, 2013~No~RX~TAKEDA PHARMACEUTICALS USA INC
N~204447~004~~Sep 30, 2013~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
ERYTHROMYCIN STEARATE~TABLET;ORAL~BRISTAMYCIN~BRISTOL~EQ 250MG BASE~A~061304~001
ERS CO
ERYTHROMYCIN STEARATE~TABLET;ORAL~BRISTAMYCIN~BRISTOL~EQ 250MG BASE~A~061887~001
ERS CO
BROMOCRIPTINE MESYLATE~TABLET;ORAL~BROMOCRIPTINE MESYLATE~LEK PHARMS~EQ 2.5MG BA
SE~A~074631~001~AB~Jan 13, 1998~No~RX~LEK PHARMACEUTICALS D D
BROMOCRIPTINE MESYLATE~TABLET;ORAL~BROMOCRIPTINE MESYLATE~MYLAN~EQ 2.5MG BASE~A~
BROMOCRIPTINE MESYLATE~TABLET;ORAL~BROMOCRIPTINE MESYLATE~PADDOCK LLC~EQ 2.5MG B
ASE~A~077646~001~AB~Oct 1, 2008~No~RX~PADDOCK LABORATORIES LLC
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~BARR~4MG~A~084468~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~IVAX SUB TEVA PHARMS
~4MG~A~084351~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS I
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~NEWTRON PHARMS~4MG~A
~086987~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEWTRON PHARMACEUTICALS INC
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~NEXGEN PHARMA INC~4M
G~A~086187~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~PAR PHARM~4MG~A~0870
09~001~~Approved Prior to Jan 1, 1982~No~DISCN~PAR PHARMACEUTICAL INC
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~PIONEER PHARMS~4MG~A
~088604~001~~Jul 13, 1984~No~DISCN~PIONEER PHARMACEUTICALS INC
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~SANDOZ~4MG~A~083215~
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~VITARINE~4MG~A~08585
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~WATSON LABS~4MG~A~08
BROMPHENIRAMINE MALEATE~TABLET;ORAL~BROMPHENIRAMINE MALEATE~WATSON LABS~4MG~A~08
BUCLIZINE HYDROCHLORIDE~TABLET;ORAL~BUCLADIN-S~STUART PHARMS~50MG~N~010911~006~~
Approved Prior to Jan 1, 1982~No~DISCN~STUART PHARMACEUTICALS DIV ICI AMERICAS
BUMETANIDE~TABLET;ORAL~BUMETANIDE~IVAX SUB TEVA PHARMS~0.5MG~A~074225~001~AB~Apr
BUMETANIDE~TABLET;ORAL~BUMETANIDE~IVAX SUB TEVA PHARMS~1MG~A~074225~002~AB~Apr 2
BUMETANIDE~TABLET;ORAL~BUMETANIDE~IVAX SUB TEVA PHARMS~2MG~A~074225~003~AB~Apr 2
BUMETANIDE~TABLET;ORAL~BUMETANIDE~SANDOZ~0.5MG~A~074700~001~AB~Nov 21, 1996~No~R
X~SANDOZ INC
BUMETANIDE~TABLET;ORAL~BUMETANIDE~SANDOZ~1MG~A~074700~002~AB~Nov 21, 1996~No~RX~
SANDOZ INC
BUMETANIDE~TABLET;ORAL~BUMETANIDE~SANDOZ~2MG~A~074700~003~AB~Nov 21, 1996~Yes~RX
~SANDOZ INC
BUMETANIDE~TABLET;ORAL~BUMEX~VALIDUS PHARMS INC~0.5MG~N~018225~002~~Feb 28, 1983
~No~DISCN~VALIDUS PHARMACEUTICALS INC
BUMETANIDE~TABLET;ORAL~BUMEX~VALIDUS PHARMS INC~1MG~N~018225~001~~Feb 28, 1983~N
o~DISCN~VALIDUS PHARMACEUTICALS INC
BUMETANIDE~TABLET;ORAL~BUMEX~VALIDUS PHARMS INC~2MG~N~018225~003~~Jun 14, 1985~N

o~DISCN~VALIDUS PHARMACEUTICALS INC
SODIUM PHENYLBUTYRATE~TABLET;ORAL~BUPHENYL~HYPERION THERAPS INC~500MG~N~020572~0
01~AB~May 13, 1996~Yes~RX~HYPERION THERAPEUTICS INC
BUPROPION HYDROCHLORIDE~TABLET;ORAL~BUPROPION HYDROCHLORIDE~APOTEX INC~75MG~A~07
6143~001~AB~Jan 17, 2006~No~RX~APOTEX INC ETOBICOKE SITE
BUPROPION HYDROCHLORIDE~TABLET;ORAL~BUPROPION HYDROCHLORIDE~APOTEX INC~100MG~A~0
76143~002~AB~Jan 17, 2006~No~RX~APOTEX INC ETOBICOKE SITE
BUPROPION HYDROCHLORIDE~TABLET;ORAL~BUPROPION HYDROCHLORIDE~MYLAN~75MG~A~075491~
BUPROPION HYDROCHLORIDE~TABLET;ORAL~BUPROPION HYDROCHLORIDE~MYLAN~100MG~A~075491
~002~AB~Apr 17, 2000~No~RX~MYLAN PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE~TABLET;ORAL~BUPROPION HYDROCHLORIDE~SANDOZ~75MG~A~075584
~001~AB~Feb 7, 2000~No~RX~SANDOZ INC
3~001~~Oct 10, 2000~No~DISCN~SANDOZ INC
BUPROPION HYDROCHLORIDE~TABLET;ORAL~BUPROPION HYDROCHLORIDE~TEVA~75MG~A~075310~0
01~~Nov 29, 1999~No~DISCN~TEVA PHARMACEUTICALS USA INC
BUPROPION HYDROCHLORIDE~TABLET;ORAL~BUPROPION HYDROCHLORIDE~TEVA~100MG~A~075310~
002~~Nov 29, 1999~No~DISCN~TEVA PHARMACEUTICALS USA INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPAR~BRISTOL MYERS SQUIBB~5MG~N~018731~001
~~Sep 29, 1986~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUT
E
2~~Sep 29, 1986~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITU
TE
3~~Apr 22, 1996~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITU
TE
4~~Apr 22, 1996~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITU
TE
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~ACCORD HLTHCARE~5MG~
A~202557~001~AB~Dec 30, 2014~No~RX~ACCORD HEALTHCARE INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~ACCORD HLTHCARE~7.5M
G~A~202557~002~AB~Dec 30, 2014~No~RX~ACCORD HEALTHCARE INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~ACCORD HLTHCARE~10MG
~A~202557~003~AB~Dec 30, 2014~No~RX~ACCORD HEALTHCARE INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~APOTEX~5MG~A~075521~
001~~Apr 5, 2002~No~DISCN~APOTEX INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~APOTEX~10MG~A~075521
~002~~Apr 5, 2002~No~DISCN~APOTEX INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~APOTEX~15MG~A~075521
~003~~Apr 5, 2002~No~DISCN~APOTEX INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~DR REDDYS LABS LTD~5
MG~A~078246~001~AB~Feb 27, 2009~No~RX~DR REDDYS LABORATORIES LTD
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~EGIS~5MG~A~075119~00

1~~Mar 14, 2002~No~DISCN~EGIS PLC
02~~Mar 14, 2002~No~DISCN~EGIS PLC
03~~Jan 23, 2003~No~DISCN~EGIS PLC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~IVAX SUB TEVA PHARMS
~5MG~A~075385~001~~Mar 1, 2002~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMA
CEUTICALS USA
~10MG~A~075385~002~~Mar 1, 2002~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
ACEUTICALS USA
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~MYLAN~5MG~A~075272~0
01~AB~Mar 1, 2002~No~RX~MYLAN PHARMACEUTICALS INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~MYLAN~5MG~A~075467~0
01~AB~Feb 28, 2002~No~RX~MYLAN PHARMACEUTICALS INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~MYLAN~7.5MG~A~075467
~002~AB~Mar 28, 2001~No~RX~MYLAN PHARMACEUTICALS INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~MYLAN~10MG~A~075272~
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~NESHER PHARMS~5MG~A~
075572~001~~Feb 27, 2002~No~DISCN~NESHER PHARMACEUTICALS USA LLC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~NESHER PHARMS~10MG~A
~075572~002~~Feb 27, 2002~No~DISCN~NESHER PHARMACEUTICALS USA LLC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~NESHER PHARMS~15MG~A
~075572~003~~Feb 27, 2002~No~DISCN~NESHER PHARMACEUTICALS USA LLC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~PROSAM LABS~5MG~A~07
5388~001~~May 9, 2002~No~DISCN~PROSAM LABS LLC
78302~001~AB~Dec 17, 2007~No~RX~PROSAM LABS LLC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~SANDOZ~5MG~A~075413~
001~~Mar 19, 2002~No~DISCN~SANDOZ INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~SANDOZ~10MG~A~075413
~002~~Mar 19, 2002~No~DISCN~SANDOZ INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~SANDOZ~15MG~A~075413
~003~~Mar 19, 2002~No~DISCN~SANDOZ INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~STRIDES ARCOLAB LTD~
5MG~A~202330~001~AB~Aug 25, 2014~No~RX~STRIDES ARCOLAB LTD
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~TEVA~5MG~A~075022~00

03~AB~Feb 28, 2002~Yes~RX~TEVA PHARMACEUTICALS USA INC
04~AB~Mar 25, 2004~No~RX~TEVA PHARMACEUTICALS USA INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~WATSON LABS~5MG~A~07
4253~001~AB~Mar 28, 2001~No~RX~WATSON LABORATORIES INC
BUSPIRONE HYDROCHLORIDE~TABLET;ORAL~BUSPIRONE HYDROCHLORIDE~ZYDUS PHARMS USA INC
~5MG~A~078888~001~AB~Feb 7, 2014~No~RX~ZYDUS PHARMACEUTICALS USA INC
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL~BUNDY~30MG~A~085550~001~~Approved P
rior to Jan 1, 1982~No~DISCN~CM BUNDY CO
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~SANDOZ~15MG~A~084292~003~~Fe
b 9, 1982~No~DISCN~SANDOZ INC
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~SANDOZ~15MG~A~085938~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~SOLVAY~16.2MG~A~083606~001~~
Approved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~TEVA~15MG~A~088632~001~~May
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~TEVA~30MG~A~088631~001~~May
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~WATSON LABS~15MG~A~085764~00
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~WATSON LABS~30MG~A~085772~00
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~WHITEWORTH TOWN PLSN~15MG~A~
083325~002~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
BUTABARBITAL SODIUM~TABLET;ORAL~BUTABARBITAL SODIUM~WHITEWORTH TOWN PLSN~30MG~A~
ACETAMINOPHEN; BUTALBITAL~TABLET;ORAL~BUTALBITAL AND ACETAMINOPHEN~HALSEY~325MG;
50MG~A~089568~001~~Oct 5, 1988~No~DISCN~HALSEY DRUG CO INC
ACETAMINOPHEN; BUTALBITAL~TABLET;ORAL~BUTALBITAL AND ACETAMINOPHEN~NEXGEN PHARMA
~300MG;50MG~A~090956~001~~Aug 23, 2011~Yes~RX~NEXGEN PHARMA INC
ACETAMINOPHEN; BUTALBITAL~TABLET;ORAL~BUTALBITAL AND ACETAMINOPHEN~WATSON LABS~3
25MG;50MG~A~087550~001~~Oct 19, 1984~No~DISCN~WATSON LABORATORIES INC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ACETAMINOPHEN AND CA
FFEINE~ABLE~325MG;50MG;40MG~A~040390~001~~Jul 23, 2001~No~DISCN~ABLE LABORATORIE
S INC

FFEINE~ABLE~500MG;50MG;40MG~A~040394~001~~Jul 23, 2001~No~DISCN~ABLE LABORATORIE
S INC
FFEINE~GILBERT LABS~325MG;50MG;40MG~A~087629~001~~Nov 13, 1984~No~DISCN~GILBERT
LABORATORIES
FFEINE~HIKMA PHARMS LLC~325MG;50MG;40MG~A~089718~001~AA~Jun 12, 1995~No~RX~HIKMA
PHARMACEUTICALS LLC
FFEINE~HIKMA PHARMS LLC~500MG;50MG;40MG~A~040336~001~~Aug 18, 1999~No~DISCN~HIKM
A PHARMACEUTICALS LLC
FFEINE~LANNETT HOLDINGS INC~325MG;50MG;40MG~A~200243~001~AA~Sep 13, 2012~No~RX~L
ANNETT HOLDINGS INC
FFEINE~MALLINCKRODT~325MG;50MG;40MG~A~087804~001~AA~Jan 24, 1985~No~RX~MALLINCKR
ODT CHEMICAL INC
FFEINE~MIKART~325MG;50MG;40MG~A~089175~001~AA~Jan 21, 1987~No~RX~MIKART INC
FFEINE~MIKART~750MG;50MG;40MG~A~040496~001~~Dec 23, 2003~No~DISCN~MIKART INC
FFEINE~MIRROR PHARMS~325MG;50MG;40MG~A~040864~001~~Dec 1, 2008~No~DISCN~MIRROR P
HARMACEUTICALS LLC
FFEINE~MIRROR PHARMS LLC~500MG;50MG;40MG~A~040883~001~~Dec 23, 2008~No~DISCN~MIR
ROR PHARMACEUTICALS LLC
FFEINE~MUTUAL PHARM~325MG;50MG;40MG~A~040601~001~~Jul 29, 2005~No~DISCN~MUTUAL P
HARMACEUTICAL CO INC
FFEINE~VINTAGE PHARMS~325MG;50MG;40MG~A~040511~001~AA~Aug 27, 2003~Yes~RX~VINTAG
E PHARMACEUTICALS INC
FFEINE~VINTAGE PHARMS~500MG;50MG;40MG~A~040513~001~~Aug 25, 2003~No~DISCN~VINTAG
FFEINE~WATSON LABS~325MG;50MG;40MG~A~089536~001~~Feb 16, 1988~No~DISCN~WATSON LA
BORATORIES INC
FFEINE~WATSON LABS~500MG;50MG;40MG~A~040267~001~~Jul 30, 1998~No~DISCN~WATSON LA
BORATORIES INC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~ACTAV
IS ELIZABETH~325MG;50MG;40MG~A~086710~002~~Aug 23, 1983~No~DISCN~ACTAVIS ELIZABE
TH LLC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~HALSE
Y~325MG;50MG;40MG~A~089448~001~~Dec 1, 1986~No~DISCN~HALSEY DRUG CO INC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~HIKMA
INTL PHARMS~325MG;50MG;40MG~A~086162~002~AA~Feb 16, 1984~Yes~RX~HIKMA INTERNATI
ONAL PHARMACEUTICALS LLC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~IVAX
PHARMS~325MG;50MG;40MG~A~085441~002~~Oct 31, 1984~No~DISCN~IVAX PHARMACEUTICALS
INC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~PURAC
AP PHARM~325MG;50MG;40MG~A~087048~002~~Dec 9, 1983~No~DISCN~PURACAP PHARMACEUTIC
AL LLC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~QUANT
UM PHARMICS~325MG;50MG;40MG~A~088972~001~~Jun 18, 1985~No~DISCN~QUANTUM PHARMICS
LTD
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~SANDO

Z~325MG;50MG;40MG~A~086398~002~~Apr 6, 1984~No~DISCN~SANDOZ INC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~BUTALBITAL, ASPIRIN AND CAFFEINE~WATSO
N LABS~325MG;50MG;40MG~A~086237~002~~Mar 23, 1984~No~DISCN~WATSON LABORATORIES I
NC
ACETAMINOPHEN; BUTALBITAL~TABLET;ORAL~BUTAPAP~MIKART~325MG;50MG~A~089987~001~~Oc
t 26, 1992~Yes~RX~MIKART INC
ACETAMINOPHEN; BUTALBITAL~TABLET;ORAL~BUTAPAP~MIKART~650MG;50MG~A~089988~001~~Oc
t 26, 1992~No~DISCN~MIKART INC
PHENYLBUTAZONE~TABLET;ORAL~BUTAZOLIDIN~NOVARTIS~100MG~N~008319~008~~Approved Pri
or to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
BUTABARBITAL SODIUM~TABLET;ORAL~BUTISOL SODIUM~MEDA PHARMS~15MG~N~000793~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~MEDA PHARMACEUTICALS INC
proved Prior to Jan 1, 1982~Yes~RX~MEDA PHARMACEUTICALS INC
proved Prior to Jan 1, 1982~Yes~RX~MEDA PHARMACEUTICALS INC
BUTABARBITAL SODIUM~TABLET;ORAL~BUTISOL SODIUM~MEDA PHARMS~100MG~N~000793~005~~A
pproved Prior to Jan 1, 1982~No~DISCN~MEDA PHARMACEUTICALS INC
NEBIVOLOL HYDROCHLORIDE~TABLET;ORAL~BYSTOLIC~FOREST LABS~EQ 2.5MG BASE~N~021742~
002~~Dec 17, 2007~No~RX~FOREST LABORATORIES INC
NEBIVOLOL HYDROCHLORIDE~TABLET;ORAL~BYSTOLIC~FOREST LABS~EQ 5MG BASE~N~021742~00
05~~Oct 8, 2008~Yes~RX~FOREST LABORATORIES INC
CABERGOLINE~TABLET;ORAL~CABERGOLINE~ACTAVIS LABS FL INC~0.5MG~A~078035~001~AB~Ap
r 21, 2008~No~RX~ACTAVIS LABORATORIES FL INC
CABERGOLINE~TABLET;ORAL~CABERGOLINE~APOTEX CORP~0.5MG~A~201503~001~AB~Mar 8, 201
3~No~RX~APOTEX CORP
CABERGOLINE~TABLET;ORAL~CABERGOLINE~IMPAX LABS INC~0.5MG~A~077843~001~AB~Jul 3,
2007~No~RX~IMPAX LABORATORIES INC
CABERGOLINE~TABLET;ORAL~CABERGOLINE~IVAX SUB TEVA PHARMS~0.5MG~A~077750~001~AB~M
ar 7, 2007~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CABERGOLINE~TABLET;ORAL~CABERGOLINE~MYLAN PHARMS INC~0.5MG~A~202947~001~AB~Dec 2
CABERGOLINE~TABLET;ORAL~CABERGOLINE~PAR PHARM~0.5MG~A~076310~001~AB~Dec 29, 2005
~Yes~RX~PAR PHARMACEUTICAL INC
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM~TABLET;ORAL~CADUET~PFIZER~EQ 2.5MG BAS
E;EQ 10MG BASE~N~021540~009~AB~Jul 29, 2004~No~RX~PFIZER INC
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM~TABLET;ORAL~CADUET~PFIZER~EQ 5MG BASE;
EQ 10MG BASE~N~021540~001~AB~Jan 30, 2004~No~RX~PFIZER INC
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM~TABLET;ORAL~CADUET~PFIZER~EQ 10MG BASE
;EQ 10MG BASE~N~021540~005~AB~Jan 30, 2004~No~RX~PFIZER INC
;EQ 80MG BASE~N~021540~008~AB~Jan 30, 2004~Yes~RX~PFIZER INC

CAFFEINE; ERGOTAMINE TARTRATE~TABLET;ORAL~CAFERGOT~NOVARTIS~100MG;1MG~N~006620~0
CAFFEINE; ERGOTAMINE TARTRATE~TABLET;ORAL~CAFERGOT~SANDOZ~100MG;1MG~A~084294~001
~AA~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~CALAN~GD SEARLE LLC~40MG~N~018817~003~AB~Feb
23, 1988~No~RX~GD SEARLE LLC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~CALAN~GD SEARLE LLC~80MG~N~018817~001~AB~Sep
10, 1984~No~RX~GD SEARLE LLC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~CALAN~GD SEARLE LLC~120MG~N~018817~002~AB~Se
p 10, 1984~Yes~RX~GD SEARLE LLC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~CALAN~GD SEARLE LLC~160MG~N~018817~004~~Feb
23, 1988~No~DISCN~GD SEARLE LLC
CALCIUM ACETATE~TABLET;ORAL~CALCIUM ACETATE~INVAGEN PHARMS~EQ 169MG CALCIUM~A~20
2420~001~AB~Feb 5, 2013~No~RX~INVAGEN PHARMACEUTICALS INC
CALCIUM ACETATE~TABLET;ORAL~CALCIUM ACETATE~PADDOCK LLC~EQ 169MG CALCIUM~A~09156
1~001~AB~Apr 13, 2011~No~RX~PADDOCK LABORATORIES LLC
CALCIUM ACETATE~TABLET;ORAL~CALCIUM ACETATE~ROXANE~EQ 169MG CALCIUM~A~077693~001
~~Jan 30, 2008~No~DISCN~ROXANE LABORATORIES INC
CALCIUM ACETATE~TABLET;ORAL~CALCIUM ACETATE~ZYDUS PHARMS USA INC~EQ 169MG CALCIU
M~A~202885~001~AB~Jan 22, 2015~No~RX~ZYDUS PHARMACEUTICALS USA INC
EDETATE CALCIUM DISODIUM~TABLET;ORAL~CALCIUM DISODIUM VERSENATE~MEDICIS~500MG~N~
008922~002~~Approved Prior to Jan 1, 1982~No~DISCN~MEDICIS PHARMACEUTICAL CORP
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~CAM-AP-ES~
TG UNITED LABS~25MG;15MG;0.1MG~A~084897~001~~Approved Prior to Jan 1, 1982~No~DI
SCN~TG UNITED LABS LLC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~CAM-METRAZINE~ABC HOLDING~35MG~A~085511~001
~~Approved Prior to Jan 1, 1982~No~DISCN~ABC HOLDING CORP
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~CAM-METRAZINE~CAMALL~35MG~A~085756~001~~App
roved Prior to Jan 1, 1982~No~DISCN~CAMALL CO INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~CAM-METRAZINE~TG UNITED LABS~35MG~A~083922~
001~~Approved Prior to Jan 1, 1982~No~DISCN~TG UNITED LABS LLC
AMODIAQUINE HYDROCHLORIDE~TABLET;ORAL~CAMOQUIN HYDROCHLORIDE~PARKE DAVIS~EQ 200M
G BASE~N~006441~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARN
ER LAMBERT CO
CANDESARTAN CILEXETIL~TABLET;ORAL~CANDESARTAN CILEXETIL~APOTEX INC~4MG~A~202079~
001~AB~Jan 10, 2014~No~RX~APOTEX INC
CANDESARTAN CILEXETIL~TABLET;ORAL~CANDESARTAN CILEXETIL~APOTEX INC~8MG~A~202079~
002~AB~Jan 10, 2014~No~RX~APOTEX INC
CANDESARTAN CILEXETIL~TABLET;ORAL~CANDESARTAN CILEXETIL~APOTEX INC~16MG~A~202079
~003~AB~Jan 10, 2014~No~RX~APOTEX INC
CANDESARTAN CILEXETIL~TABLET;ORAL~CANDESARTAN CILEXETIL~APOTEX INC~32MG~A~202079
~004~AB~Jan 10, 2014~No~RX~APOTEX INC
CANDESARTAN CILEXETIL~TABLET;ORAL~CANDESARTAN CILEXETIL~SANDOZ~4MG~A~078702~001~
AB~May 3, 2013~No~RX~SANDOZ INC
CANDESARTAN CILEXETIL~TABLET;ORAL~CANDESARTAN CILEXETIL~SANDOZ~8MG~A~078702~002~
AB~May 3, 2013~No~RX~SANDOZ INC
CANDESARTAN CILEXETIL~TABLET;ORAL~CANDESARTAN CILEXETIL~SANDOZ~16MG~A~078702~003
~AB~May 3, 2013~No~RX~SANDOZ INC
CANDESARTAN CILEXETIL~TABLET;ORAL~CANDESARTAN CILEXETIL~SANDOZ~32MG~A~078702~004
~AB~May 3, 2013~No~RX~SANDOZ INC
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE~TABLET;ORAL~CANDESARTAN CILEXETIL AND
HYDROCHLOROTHIAZIDE~APOTEX INC~16MG;12.5MG~A~202884~001~AB~Dec 4, 2012~No~RX~AP
OTEX INC

HYDROCHLOROTHIAZIDE~APOTEX INC~32MG;12.5MG~A~202884~002~AB~Dec 4, 2012~No~RX~AP
OTEX INC
HYDROCHLOROTHIAZIDE~APOTEX INC~32MG;25MG~A~202884~003~AB~Jun 3, 2013~No~RX~APOT
EX INC
HYDROCHLOROTHIAZIDE~DR REDDYS LABS LTD~16MG;12.5MG~A~202965~001~AB~Jun 3, 2013~
No~RX~DR REDDYS LABORATORIES LTD
HYDROCHLOROTHIAZIDE~DR REDDYS LABS LTD~32MG;12.5MG~A~202965~002~AB~Jun 3, 2013~
No~RX~DR REDDYS LABORATORIES LTD
HYDROCHLOROTHIAZIDE~DR REDDYS LABS LTD~32MG;25MG~A~202965~003~AB~Jun 3, 2013~No
~RX~DR REDDYS LABORATORIES LTD
HYDROCHLOROTHIAZIDE~MACLEODS PHARMS LTD~16MG;12.5MG~A~204100~001~AB~Feb 27, 201
5~No~RX~MACLEODS PHARMACEUTICALS LTD
HYDROCHLOROTHIAZIDE~MACLEODS PHARMS LTD~32MG;12.5MG~A~204100~002~AB~Feb 27, 201
5~No~RX~MACLEODS PHARMACEUTICALS LTD
HYDROCHLOROTHIAZIDE~MACLEODS PHARMS LTD~32MG;25MG~A~204100~003~AB~Feb 27, 2015~
No~RX~MACLEODS PHARMACEUTICALS LTD
HYDROCHLOROTHIAZIDE~MYLAN LABS~16MG;12.5MG~A~090704~001~AB~Dec 4, 2012~No~RX~MY
LAN LABORATORIES LTD
HYDROCHLOROTHIAZIDE~MYLAN LABS~32MG;12.5MG~A~090704~002~AB~Dec 4, 2012~No~RX~MY
LAN LABORATORIES LTD
HYDROCHLOROTHIAZIDE~MYLAN LABS~32MG;25MG~A~090704~003~AB~Dec 4, 2012~No~RX~MYLA
N LABORATORIES LTD
MEPENZOLATE BROMIDE~TABLET;ORAL~CANTIL~SANOFI AVENTIS US~25MG~N~010679~003~~Appr
oved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
IBUPROFEN~TABLET;ORAL~CAP-PROFEN~PERRIGO~200MG~A~072097~001~~Dec 8, 1987~No~DISC
N~L PERRIGO CO
CAPECITABINE~TABLET;ORAL~CAPECITABINE~MYLAN PHARMS INC~150MG~A~090943~001~AB~Aug
CAPECITABINE~TABLET;ORAL~CAPECITABINE~MYLAN PHARMS INC~500MG~A~090943~002~AB~Aug
CAPECITABINE~TABLET;ORAL~CAPECITABINE~TEVA PHARMS USA~150MG~A~091649~001~AB~Sep
CAPECITABINE~TABLET;ORAL~CAPECITABINE~TEVA PHARMS USA~500MG~A~091649~002~AB~Sep
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~CAPITAL AND CODEINE~CARNRICK~325MG;
30MG~A~083643~001~~Approved Prior to Jan 1, 1982~No~DISCN~CARNRICK LABORATORIES
INC DIV GW CARNRICK CO
CAPTOPRIL~TABLET;ORAL~CAPOTEN~PAR PHARM~12.5MG~N~018343~005~AB~Jan 17, 1985~No~R
X~PAR PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPOTEN~PAR PHARM~25MG~N~018343~002~AB~Approved Prior to J
an 1, 1982~No~RX~PAR PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPOTEN~PAR PHARM~37.5MG~N~018343~006~~Sep 17, 1986~No~DIS
CN~PAR PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPOTEN~PAR PHARM~50MG~N~018343~001~AB~Approved Prior to J
an 1, 1982~No~RX~PAR PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPOTEN~PAR PHARM~75MG~N~018343~007~~Jun 13, 1995~No~DISCN
~PAR PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPOTEN~PAR PHARM~100MG~N~018343~003~AB~Approved Prior to
Jan 1, 1982~Yes~RX~PAR PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPOTEN~PAR PHARM~150MG~N~018343~004~~Jun 13, 1995~No~DISC

N~PAR PHARMACEUTICAL INC
CAPTOPRIL; HYDROCHLOROTHIAZIDE~TABLET;ORAL~CAPOZIDE 25/15~APOTHECON~25MG;15MG **
r safety or efficacy reasons**~N~018709~001~~Oct 12, 1984~No~DISCN~APOTHECON INC
VANDETANIB~TABLET;ORAL~CAPRELSA~IPR PHARMS INC~100MG~N~022405~001~~Apr 6, 2011~N
o~RX~IPR PHARMACEUTICALS INC
VANDETANIB~TABLET;ORAL~CAPRELSA~IPR PHARMS INC~300MG~N~022405~002~~Apr 6, 2011~Y
es~RX~IPR PHARMACEUTICALS INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~APOTEX~12.5MG~A~074737~001~AB~Oct 28, 1998~No~RX
~APOTEX INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~APOTEX~25MG~A~074737~002~AB~Oct 28, 1998~No~RX~A
POTEX INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~APOTEX~50MG~A~074737~003~AB~Oct 28, 1998~No~RX~A
POTEX INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~APOTEX~100MG~A~074737~004~AB~Oct 28, 1998~No~RX~
APOTEX INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~APOTHECON~12.5MG~A~074472~001~~Mar 31, 1995~No~D
ISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~APOTHECON~25MG~A~074472~002~~Mar 31, 1995~No~DIS
CN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~APOTHECON~50MG~A~074472~003~~Mar 31, 1995~No~DIS
CN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~APOTHECON~100MG~A~074472~004~~Mar 31, 1995~No~DI
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~DAVA PHARMS INC~12.5MG~A~074423~001~~Feb 13, 199
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~DAVA PHARMS INC~25MG~A~074423~002~~Feb 13, 1996~
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~DAVA PHARMS INC~50MG~A~074423~003~~Feb 13, 1996~
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~DAVA PHARMS INC~100MG~A~074423~004~~Feb 13, 1996
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~EGIS PHARMS~12.5MG~A~074748~004~~May 29, 1997~No
~DISCN~EGIS PHARMACEUTICALS LTD
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~EGIS PHARMS~25MG~A~074748~002~~May 29, 1997~No~D
ISCN~EGIS PHARMACEUTICALS LTD
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~EGIS PHARMS~50MG~A~074748~001~~May 29, 1997~No~D
ISCN~EGIS PHARMACEUTICALS LTD
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~EGIS PHARMS~100MG~A~074748~003~~May 29, 1997~No~
DISCN~EGIS PHARMACEUTICALS LTD
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~HIKMA PHARMS LLC~12.5MG~A~074505~001~AB~Feb 13,
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~HIKMA PHARMS LLC~25MG~A~074505~002~AB~Feb 13, 19

CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~IVAX SUB TEVA PHARMS~12.5MG~A~074590~004~~Aug 30
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~IVAX SUB TEVA PHARMS~25MG~A~074590~002~~Aug 30,
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~MYLAN~12.5MG~A~074434~001~AB~Feb 13, 1996~No~RX~
MYLAN LABORATORIES INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~MYLAN~25MG~A~074434~002~AB~Feb 13, 1996~No~RX~MY
LAN LABORATORIES INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~MYLAN~50MG~A~074434~003~AB~Feb 13, 1996~No~RX~MY
LAN LABORATORIES INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~MYLAN~100MG~A~074434~004~AB~Feb 13, 1996~No~RX~M
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PAR PHARM~12.5MG~A~074493~001~~Feb 13, 1996~No~D
ISCN~PAR PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PAR PHARM~25MG~A~074493~002~~Feb 13, 1996~No~DIS
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PAR PHARM~50MG~A~074493~003~~Feb 13, 1996~No~DIS
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PAR PHARM~100MG~A~074493~004~~Feb 13, 1996~No~DI
SCN~PAR PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PRINSTON INC~12.5MG~A~074477~001~~Feb 13, 1996~N
o~DISCN~PRINSTON PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PRINSTON INC~25MG~A~074477~002~~Feb 13, 1996~No~
DISCN~PRINSTON PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PRINSTON INC~50MG~A~074477~003~~Feb 13, 1996~No~
DISCN~PRINSTON PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PRINSTON INC~100MG~A~074477~004~~Feb 13, 1996~No
~DISCN~PRINSTON PHARMACEUTICAL INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PUREPAC PHARM~12.5MG~A~074640~001~~Mar 31, 1997~
No~DISCN~PUREPAC PHARMACEUTICAL CO
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PUREPAC PHARM~25MG~A~074640~002~~Mar 31, 1997~No
~DISCN~PUREPAC PHARMACEUTICAL CO
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PUREPAC PHARM~50MG~A~074640~003~~Mar 31, 1997~No
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~PUREPAC PHARM~100MG~A~074640~004~~Mar 31, 1997~N
o~DISCN~PUREPAC PHARMACEUTICAL CO
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~12.5MG~A~074363~001~AB~Nov 9, 1995~No~RX~
SANDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~12.5MG~A~074481~001~~Feb 13, 1996~No~DISC
N~SANDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~12.5MG~A~074519~001~~Feb 13, 1996~No~DISC
N~SANDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~25MG~A~074363~002~AB~Nov 9, 1995~No~RX~SA
NDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~25MG~A~074481~002~~Feb 13, 1996~No~DISCN~
SANDOZ INC
SANDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~50MG~A~074363~003~AB~Nov 9, 1995~No~RX~SA
NDOZ INC
SANDOZ INC
SANDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~100MG~A~074363~004~AB~Nov 9, 1995~No~RX~S
ANDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~100MG~A~074481~004~~Feb 13, 1996~No~DISCN
~SANDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~SANDOZ~100MG~A~074519~004~~Feb 13, 1996~No~DISCN
~SANDOZ INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~STASON~12.5MG~A~074677~004~AB~May 30, 1997~No~RX
~STASON INDUSTRIAL CORP
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~STASON~25MG~A~074677~002~AB~May 30, 1997~No~RX~S
TASON INDUSTRIAL CORP
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~STASON~50MG~A~074677~001~AB~May 30, 1997~No~RX~S
TASON INDUSTRIAL CORP
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~STASON~100MG~A~074677~003~AB~May 30, 1997~No~RX~
STASON INDUSTRIAL CORP
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~12.5MG~A~074322~001~AB~Feb 13, 1996~No~RX~T
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~12.5MG~A~074433~001~~Feb 13, 1996~No~DISCN~
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~12.5MG~A~074483~001~~Feb 13, 1996~No~DISCN~
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~25MG~A~074322~002~AB~Feb 13, 1996~No~RX~TEV
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~25MG~A~074433~002~~Feb 13, 1996~No~DISCN~TE
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~50MG~A~074322~003~AB~Feb 13, 1996~No~RX~TEV
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~100MG~A~074322~004~AB~Feb 13, 1996~No~RX~TE
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~100MG~A~074433~004~~Feb 13, 1996~No~DISCN~T
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA~100MG~A~074483~004~~Feb 13, 1996~No~DISCN~T
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA PHARMS~12.5MG~A~074462~001~~Feb 13, 1996~No
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA PHARMS~25MG~A~074462~002~~Feb 13, 1996~No~D
ISCN~TEVA PHARMACEUTICALS USA
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA PHARMS~50MG~A~074462~003~~Feb 13, 1996~No~D
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~TEVA PHARMS~100MG~A~074462~004~~Feb 13, 1996~No~
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~VINTAGE PHARMS LLC~12.5MG~A~074418~001~~Feb 13,
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~VINTAGE PHARMS LLC~25MG~A~074418~002~~Feb 13, 19
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~12.5MG~A~074386~001~AB~May 23, 1996~
No~RX~WATSON LABORATORIES INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~12.5MG~A~074451~001~~Feb 13, 1996~No
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~12.5MG~A~074576~001~~Apr 23, 1996~No
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~25MG~A~074386~002~AB~May 23, 1996~No

CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~25MG~A~074451~002~~Feb 13, 1996~No~D
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~25MG~A~074576~002~~Apr 23, 1996~No~D
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~50MG~A~074386~003~AB~May 23, 1996~No
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~50MG~A~074451~003~~Feb 13, 1996~No~D
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~50MG~A~074576~003~~Apr 23, 1996~No~D
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~100MG~A~074386~004~AB~May 23, 1996~N
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~100MG~A~074451~004~~Feb 13, 1996~No~
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WATSON LABS~100MG~A~074576~004~~Apr 23, 1996~No~
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WOCKHARDT~12.5MG~A~074532~001~AB~Mar 28, 1997~No
~RX~WOCKHARDT AMERICAS INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WOCKHARDT~25MG~A~074532~002~AB~Mar 28, 1997~No~R
X~WOCKHARDT AMERICAS INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WOCKHARDT~50MG~A~074532~003~AB~Mar 28, 1997~No~R
X~WOCKHARDT AMERICAS INC
CAPTOPRIL~TABLET;ORAL~CAPTOPRIL~WOCKHARDT~100MG~A~074532~004~AB~Mar 28, 1997~No~
RX~WOCKHARDT AMERICAS INC
CAPTOPRIL; HYDROCHLOROTHIAZIDE~TABLET;ORAL~CAPTOPRIL AND HYDROCHLOROTHIAZIDE~IVA
X SUB TEVA PHARMS~25MG;15MG~A~075055~001~~Jun 18, 1998~No~DISCN~IVAX PHARMACEUTI
CALS INC SUB TEVA PHARMACEUTICALS USA
CAPTOPRIL; HYDROCHLOROTHIAZIDE~TABLET;ORAL~CAPTOPRIL AND HYDROCHLOROTHIAZIDE~MYL
AN~25MG;15MG~A~074896~001~AB~Dec 29, 1997~No~RX~MYLAN PHARMACEUTICALS INC
AN~25MG;25MG~A~074896~002~AB~Dec 29, 1997~Yes~RX~MYLAN PHARMACEUTICALS INC
AN~50MG;15MG~A~074896~004~AB~Dec 29, 1997~Yes~RX~MYLAN PHARMACEUTICALS INC
AN~50MG;25MG~A~074896~003~AB~Dec 29, 1997~No~RX~MYLAN PHARMACEUTICALS INC
CAPTOPRIL; HYDROCHLOROTHIAZIDE~TABLET;ORAL~CAPTOPRIL AND HYDROCHLOROTHIAZIDE~TEV
A~25MG;15MG~A~074827~001~AB~Dec 29, 1997~No~RX~TEVA PHARMACEUTICALS USA INC
CAPTOPRIL; HYDROCHLOROTHIAZIDE~TABLET;ORAL~CAPTOPRIL AND HYDROCHLOROTHIAZIDE~VIN
TAGE PHARMS LLC~25MG;15MG~A~074788~001~~Dec 29, 1997~No~DISCN~VINTAGE PHARMACEUT
ICALS LLC
ICALS LLC

ICALS LLC
ICALS LLC
CAPTOPRIL; HYDROCHLOROTHIAZIDE~TABLET;ORAL~CAPTOPRIL AND HYDROCHLOROTHIAZIDE~WAT
SON LABS~50MG;25MG~A~074832~001~~Dec 29, 1997~No~DISCN~WATSON LABORATORIES INC
SUCRALFATE~TABLET;ORAL~CARAFATE~FOREST LABS INC~1GM~N~018333~001~AB~Approved Pri
or to Jan 1, 1982~Yes~RX~FOREST LABORATORIES INC
CARGLUMIC ACID~TABLET;ORAL~CARBAGLU~ORPHAN EUROPE~200MG~N~022562~001~~Mar 18, 20
10~Yes~RX~ORPHAN EUROPE
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~ACTAVIS ELIZABETH~200MG~A~071696~001~~No
v 9, 1987~No~DISCN~ACTAVIS ELIZABETH LLC
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~APOTEX INC~200MG~A~075948~001~AB~Feb 27,
2002~No~RX~APOTEX INC ETOBICOKE SITE
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~INWOOD LABS~200MG~A~070231~001~~Aug 14,
1986~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~PLIVA~200MG~A~071479~001~~Jul 24, 1987~N
o~DISCN~PLIVA INC
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~TARO~200MG~A~074649~001~AB~Oct 3, 1996~N
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~TORRENT PHARMS~100MG~A~077272~001~~Dec 7
, 2005~No~RX~TORRENT PHARMACEUTICALS LTD
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~TORRENT PHARMS~200MG~A~077272~002~AB~Dec
7, 2005~No~RX~TORRENT PHARMACEUTICALS LTD
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~USL PHARMA~200MG~A~070300~001~~May 15, 1
CARBAMAZEPINE~TABLET;ORAL~CARBAMAZEPINE~WARNER CHILCOTT~200MG~A~070429~001~~Jan
CARBIDOPA~TABLET;ORAL~CARBIDOPA~AMERIGEN PHARMS LTD~25MG~A~203261~001~AB~Mar 10,
2014~No~RX~AMERIGEN PHARMACEUTICALS LTD
CARBIDOPA; LEVODOPA~TABLET;ORAL~CARBIDOPA AND LEVODOPA~ACTAVIS ELIZABETH~10MG;10
0MG~A~074260~001~AB~Sep 3, 1993~No~RX~ACTAVIS ELIZABETH LLC
CARBIDOPA; LEVODOPA~TABLET;ORAL~CARBIDOPA AND LEVODOPA~APOTEX INC~10MG;100MG~A~0
CARBIDOPA; LEVODOPA~TABLET;ORAL~CARBIDOPA AND LEVODOPA~MYLAN~10MG;100MG~A~090324
~001~AB~Sep 28, 2009~No~RX~MYLAN PHARMACEUTICALS INC
CARBIDOPA; LEVODOPA~TABLET;ORAL~CARBIDOPA AND LEVODOPA~SANDOZ~10MG;100MG~A~07358
CARBIDOPA; LEVODOPA~TABLET;ORAL~CARBIDOPA AND LEVODOPA~SCS~10MG;100MG~A~074080~0

01~~Mar 25, 1994~No~DISCN~SCS PHARMACEUTICALS
CARBIDOPA; LEVODOPA~TABLET;ORAL~CARBIDOPA AND LEVODOPA~SUN PHARM INDS~10MG;100MG
~A~078536~001~AB~Oct 28, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
CARBIDOPA; LEVODOPA~TABLET;ORAL~CARBIDOPA AND LEVODOPA~TEVA~10MG;100MG~A~073618~
001~AB~Aug 28, 1992~No~RX~TEVA PHARMACEUTICALS USA INC
CARBIDOPA; LEVODOPA~TABLET;ORAL~CARBIDOPA AND LEVODOPA~WATSON LABS~10MG;100MG~A~
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~CARBIDOPA, LEVODOPA AND ENTACAPONE~S
UN PHARMA GLOBAL~25MG;200MG;100MG~A~079085~001~AB~May 10, 2012~No~RX~SUN PHARMA
GLOBAL FZE
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~CARBIDOPA, LEVODOPA AND ENTACAPONE~S
UN PHARMA GLOBAL~37.5MG;200MG;150MG~A~079085~002~AB~May 10, 2012~No~RX~SUN PHARM
A GLOBAL FZE
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~CARBIDOPA, LEVODOPA AND ENTACAPONE~W
OCKHARDT LTD~12.5MG;200MG;50MG~A~090786~001~AB~Nov 20, 2012~No~RX~WOCKHARDT LTD
OCKHARDT LTD~25MG;200MG;100MG~A~090833~002~AB~Nov 20, 2012~No~RX~WOCKHARDT LTD
OCKHARDT LTD~31.25MG;200MG;125MG~A~090833~003~AB~Nov 20, 2012~No~RX~WOCKHARDT LT
D
OCKHARDT LTD~50MG;200MG;200MG~A~090833~005~AB~Nov 20, 2012~No~RX~WOCKHARDT LTD
CARBINOXAMINE MALEATE~TABLET;ORAL~CARBINOXAMINE MALEATE~CYPRESS PHARM~4MG~A~0904
17~001~AA~Aug 23, 2010~No~RX~CYPRESS PHARMACEUTICAL INC
CARBINOXAMINE MALEATE~TABLET;ORAL~CARBINOXAMINE MALEATE~INVAGEN PHARMS~4MG~A~090
435~001~AA~Apr 15, 2010~No~RX~INVAGEN PHARMACEUTICALS INC
CARBINOXAMINE MALEATE~TABLET;ORAL~CARBINOXAMINE MALEATE~MIKART~4MG~A~040442~001~
AA~Mar 19, 2003~Yes~RX~MIKART INC
CARBINOXAMINE MALEATE~TABLET;ORAL~CARBINOXAMINE MALEATE~MISSION PHARMACAL CO~4MG
~A~090756~001~AA~May 27, 2011~No~RX~MISSION PHARMACAL CO
CARBINOXAMINE MALEATE~TABLET;ORAL~CARBINOXAMINE MALEATE~VINTAGE PHARMS~4MG~A~040
639~002~AA~May 30, 2008~No~RX~VINTAGE PHARMACEUTICALS
QUINIDINE POLYGALACTURONATE~TABLET;ORAL~CARDIOQUIN~PHARM RES ASSOC~275MG~N~01164
2~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC INC
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~CARDIZEM~VALEANT INTL~30MG~N~018602~001~AB~N
ov 5, 1982~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~CARDIZEM~VALEANT INTL~60MG~N~018602~002~AB~N
ov 5, 1982~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~CARDIZEM~VALEANT INTL~90MG~N~018602~003~AB~D
ec 8, 1986~No~RX~VALEANT INTERNATIONAL BARBADOS SRL

DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~CARDIZEM~VALEANT INTL~120MG~N~018602~004~AB~
Dec 8, 1986~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
ETHOXZOLAMIDE~TABLET;ORAL~CARDRASE~PHARMACIA AND UPJOHN~62.5MG~N~011047~002~~App
roved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
ETHOXZOLAMIDE~TABLET;ORAL~CARDRASE~PHARMACIA AND UPJOHN~125MG~N~011047~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
DOXAZOSIN MESYLATE~TABLET;ORAL~CARDURA~PFIZER~EQ 1MG BASE~N~019668~001~AB~Nov 2,
1990~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC
1990~No~RX~PFIZER LABORATORIES DIV PFIZER INC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~ABLE~350MG~A~040421~001~~Jun 21, 2001~No~D
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~ACCELRX LABS~350MG~A~040576~001~AA~Jun 7,
2005~No~RX~ACCELRX LABS LLC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~AUROBINDO PHARMA~350MG~A~040792~001~AA~Aug
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~COREPHARMA~350MG~A~040397~001~~Sep 21, 200
0~No~DISCN~COREPHARMA LLC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~HIKMA INTL PHARMS~350MG~A~040124~001~~Jan
24, 1996~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~MIRROR PHARMS~350MG~A~040823~001~AA~Oct 22
, 2008~No~RX~MIRROR PHARMACEUTICALS LLC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~MUTUAL PHARM~350MG~A~089346~001~AA~Oct 17,
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~NATCO PHARMA LTD~350MG~A~090988~001~AA~Oct
28, 2014~No~RX~NATCO PHARMA LTD
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~ORIENT PHARMA CO LTD~350MG~A~205085~001~AA
~Oct 28, 2014~No~RX~ORIENT PHARMA CO LTD
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~PIONEER PHARMS~350MG~A~089390~001~~Oct 13,
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~PROSAM LABS~350MG~A~040188~001~~Mar 7, 199
7~No~DISCN~PROSAM LABS LLC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~SANDOZ~350MG~A~081025~001~~Apr 13, 1989~No
~DISCN~SANDOZ INC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~SANDOZ~350MG~A~089566~001~~Aug 30, 1988~No
~DISCN~SANDOZ INC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~SCIEGEN PHARMS INC~350MG~A~203374~001~AA~J
an 27, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~SUN PHARM INDS LTD~350MG~A~040755~001~AA~F
eb 27, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~VINTAGE PHARMS~350MG~A~040245~001~AA~Sep 8
, 1997~No~RX~VINTAGE PHARMACEUTICALS INC
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~WATSON LABS~350MG~A~040152~001~~Dec 3, 199
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~WATSON LABS~350MG~A~085433~001~~Approved P
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~WATSON LABS~350MG~A~086179~001~~Approved P
CARISOPRODOL~TABLET;ORAL~CARISOPRODOL~WATSON LABS~350MG~A~087499~001~AA~Apr 20,
ASPIRIN; CARISOPRODOL~TABLET;ORAL~CARISOPRODOL AND ASPIRIN~HERITAGE PHARMS INC~3
25MG;200MG~A~089594~001~AB~Mar 31, 1989~No~RX~HERITAGE PHARMACEUTICALS INC
ASPIRIN; CARISOPRODOL~TABLET;ORAL~CARISOPRODOL AND ASPIRIN~MIRROR PHARMS~325MG;2
00MG~A~040832~001~AB~Jan 7, 2010~No~RX~MIRROR PHARMACEUTICALS LLC
ASPIRIN; CARISOPRODOL~TABLET;ORAL~CARISOPRODOL AND ASPIRIN~PROSAM LABS~325MG;200
MG~A~040252~001~AB~Dec 10, 1997~No~RX~PROSAM LABS LLC

ASPIRIN; CARISOPRODOL~TABLET;ORAL~CARISOPRODOL AND ASPIRIN~SANDOZ~325MG;200MG~A~
040116~001~AB~Apr 25, 1996~No~RX~SANDOZ INC
ASPIRIN; CARISOPRODOL~TABLET;ORAL~CARISOPRODOL COMPOUND~WATSON LABS~325MG;200MG~
A~088809~001~~Oct 3, 1985~No~DISCN~WATSON LABORATORIES INC
ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE~TABLET;ORAL~CARISOPRODOL, ASPIRIN AND C
ODEINE PHOSPHATE~MIRROR PHARMS~325MG;200MG;16MG~A~040860~001~~Jan 7, 2010~No~DIS
CN~MIRROR PHARMACEUTICALS LLC
ODEINE PHOSPHATE~PROSAM LABS~325MG;200MG;16MG~A~040283~001~~Dec 29, 1998~No~DISC
N~PROSAM LABS LLC
ODEINE PHOSPHATE~SANDOZ~325MG;200MG;16MG~A~040118~001~AB~Apr 16, 1996~No~RX~SAND
OZ INC
LEVOCARNITINE~TABLET;ORAL~CARNITOR~SIGMA TAU~330MG~N~018948~001~AB~Dec 27, 1985~
Yes~RX~SIGMA TAU PHARMACEUTICALS INC
CARTEOLOL HYDROCHLORIDE~TABLET;ORAL~CARTROL~ABBVIE~2.5MG~N~019204~001~~Dec 28, 1
CARTEOLOL HYDROCHLORIDE~TABLET;ORAL~CARTROL~ABBVIE~5MG~N~019204~002~~Dec 28, 198
CARTEOLOL HYDROCHLORIDE~TABLET;ORAL~CARTROL~ABBVIE~10MG~N~019204~003~~Dec 28, 19
CARVEDILOL~TABLET;ORAL~CARVEDILOL~APOTEX INC~3.125MG~A~078165~001~AB~Sep 5, 2007
CARVEDILOL~TABLET;ORAL~CARVEDILOL~APOTEX INC~6.25MG~A~078165~002~AB~Sep 5, 2007~
CARVEDILOL~TABLET;ORAL~CARVEDILOL~APOTEX INC~12.5MG~A~078165~003~AB~Sep 5, 2007~
CARVEDILOL~TABLET;ORAL~CARVEDILOL~APOTEX INC~25MG~A~078165~004~AB~Sep 5, 2007~No
CARVEDILOL~TABLET;ORAL~CARVEDILOL~AUROBINDO PHARMA~3.125MG~A~078332~001~AB~Sep 5
CARVEDILOL~TABLET;ORAL~CARVEDILOL~AUROBINDO PHARMA~6.25MG~A~078332~002~AB~Sep 5,
CARVEDILOL~TABLET;ORAL~CARVEDILOL~AUROBINDO PHARMA~12.5MG~A~078332~003~AB~Sep 5,
CARVEDILOL~TABLET;ORAL~CARVEDILOL~AUROBINDO PHARMA~25MG~A~078332~004~AB~Sep 5, 2
CARVEDILOL~TABLET;ORAL~CARVEDILOL~BEXIMCO USA~3.125MG~A~078384~001~AB~Sep 5, 200
7~No~RX~BEXIMCO PHARMACEUTICALS USA INC
~No~RX~BEXIMCO PHARMACEUTICALS USA INC
~No~RX~BEXIMCO PHARMACEUTICALS USA INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~BEXIMCO USA~25MG~A~078384~004~AB~Sep 5, 2007~N
o~RX~BEXIMCO PHARMACEUTICALS USA INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~CIPLA LTD~3.125MG~A~077474~001~AB~Sep 5, 2007~
No~RX~CIPLA LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~CIPLA LTD~6.25MG~A~077474~002~AB~Sep 5, 2007~N
o~RX~CIPLA LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~CIPLA LTD~12.5MG~A~077474~003~AB~Sep 5, 2007~N
o~RX~CIPLA LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~CIPLA LTD~25MG~A~077474~004~AB~Sep 5, 2007~No~
RX~CIPLA LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~DR REDDYS LABS LTD~3.125MG~A~076649~001~AB~Sep
CARVEDILOL~TABLET;ORAL~CARVEDILOL~DR REDDYS LABS LTD~25MG~A~076649~004~AB~Sep 5,

CARVEDILOL~TABLET;ORAL~CARVEDILOL~GLENMARK GENERICS~3.125MG~A~078251~001~AB~Sep
5, 2007~No~RX~GLENMARK GENERICS LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~GLENMARK GENERICS~6.25MG~A~078251~002~AB~Sep 5
CARVEDILOL~TABLET;ORAL~CARVEDILOL~GLENMARK GENERICS~12.5MG~A~078251~003~AB~Sep 5
CARVEDILOL~TABLET;ORAL~CARVEDILOL~GLENMARK GENERICS~25MG~A~078251~004~AB~Sep 5,
CARVEDILOL~TABLET;ORAL~CARVEDILOL~HIKMA~3.125MG~A~077887~001~AB~Sep 7, 2007~No~R
CARVEDILOL~TABLET;ORAL~CARVEDILOL~HIKMA~6.25MG~A~077887~002~AB~Sep 7, 2007~No~RX
~HIKMA PHARMACEUTICALS
CARVEDILOL~TABLET;ORAL~CARVEDILOL~HIKMA~12.5MG~A~077887~003~AB~Sep 7, 2007~No~RX
~HIKMA PHARMACEUTICALS
CARVEDILOL~TABLET;ORAL~CARVEDILOL~HIKMA~25MG~A~077887~004~AB~Sep 7, 2007~No~RX~H
IKMA PHARMACEUTICALS
CARVEDILOL~TABLET;ORAL~CARVEDILOL~LUPIN~3.125MG~A~078217~001~AB~Sep 5, 2007~No~R
X~LUPIN LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~LUPIN~6.25MG~A~078217~002~AB~Sep 5, 2007~No~RX
~LUPIN LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~LUPIN~12.5MG~A~078217~003~AB~Sep 5, 2007~No~RX
~LUPIN LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~LUPIN~25MG~A~078217~004~AB~Sep 5, 2007~No~RX~L
UPIN LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~MYLAN~3.125MG~A~077316~001~AB~Sep 5, 2007~No~R
CARVEDILOL~TABLET;ORAL~CARVEDILOL~MYLAN~6.25MG~A~077316~002~AB~Sep 5, 2007~No~RX
CARVEDILOL~TABLET;ORAL~CARVEDILOL~MYLAN~12.5MG~A~077316~003~AB~Sep 5, 2007~No~RX
CARVEDILOL~TABLET;ORAL~CARVEDILOL~MYLAN~25MG~A~077316~004~AB~Sep 5, 2007~No~RX~M
CARVEDILOL~TABLET;ORAL~CARVEDILOL~PLIVA HRVATSKA DOO~3.125MG~A~078240~001~AB~Oct
30, 2007~No~RX~PLIVA HRVATSKA DOO
CARVEDILOL~TABLET;ORAL~CARVEDILOL~PLIVA HRVATSKA DOO~25MG~A~078240~004~AB~Oct 30
, 2007~No~RX~PLIVA HRVATSKA DOO
CARVEDILOL~TABLET;ORAL~CARVEDILOL~RANBAXY~3.125MG~A~076989~001~AB~Sep 5, 2007~No
~RX~RANBAXY LABORATORIES LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~RANBAXY~6.25MG~A~076989~002~AB~Sep 5, 2007~No~
CARVEDILOL~TABLET;ORAL~CARVEDILOL~RANBAXY~12.5MG~A~076989~003~AB~Sep 5, 2007~No~
CARVEDILOL~TABLET;ORAL~CARVEDILOL~RANBAXY~25MG~A~076989~004~AB~Sep 5, 2007~No~RX
CARVEDILOL~TABLET;ORAL~CARVEDILOL~SANDOZ~3.125MG~A~078227~001~AB~Sep 5, 2007~No~
RX~SANDOZ INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~SANDOZ~6.25MG~A~078227~002~AB~Sep 5, 2007~No~R
X~SANDOZ INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~SANDOZ~12.5MG~A~078227~003~AB~Sep 5, 2007~No~R
X~SANDOZ INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~SANDOZ~25MG~A~078227~004~AB~Sep 5, 2007~No~RX~
SANDOZ INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~SUN PHARM INDS INC~3.125MG~A~077346~004~AB~Sep

CARVEDILOL~TABLET;ORAL~CARVEDILOL~SUN PHARM INDS INC~25MG~A~077346~003~AB~Sep 5,
CARVEDILOL~TABLET;ORAL~CARVEDILOL~TARO~3.125MG~A~077780~001~AB~Sep 5, 2007~No~RX
~TARO PHARMACEUTICAL INDUSTRIES LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~TARO~6.25MG~A~077780~002~AB~Sep 5, 2007~No~RX~
CARVEDILOL~TABLET;ORAL~CARVEDILOL~TARO~12.5MG~A~077780~003~AB~Sep 5, 2007~No~RX~
CARVEDILOL~TABLET;ORAL~CARVEDILOL~TARO~25MG~A~077780~004~AB~Sep 5, 2007~No~RX~TA
RO PHARMACEUTICAL INDUSTRIES LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~TEVA~3.125MG~A~076373~001~AB~Sep 5, 2007~No~RX
CARVEDILOL~TABLET;ORAL~CARVEDILOL~TEVA~6.25MG~A~076373~002~AB~Sep 5, 2007~No~RX~
CARVEDILOL~TABLET;ORAL~CARVEDILOL~TEVA~12.5MG~A~076373~003~AB~Sep 5, 2007~No~RX~
CARVEDILOL~TABLET;ORAL~CARVEDILOL~TEVA~25MG~A~076373~004~AB~Sep 5, 2007~No~RX~TE
CARVEDILOL~TABLET;ORAL~CARVEDILOL~WOCKHARDT LTD~3.125MG~A~078786~001~~Dec 22, 20
09~No~DISCN~WOCKHARDT LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~WOCKHARDT LTD~25MG~A~078786~004~~Dec 22, 2009~
No~DISCN~WOCKHARDT LTD
CARVEDILOL~TABLET;ORAL~CARVEDILOL~ZYDUS PHARMS USA INC~3.125MG~A~077614~004~AB~S
ep 5, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~ZYDUS PHARMS USA INC~6.25MG~A~077614~001~AB~Se
p 5, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~ZYDUS PHARMS USA INC~12.5MG~A~077614~002~AB~Se
p 5, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
CARVEDILOL~TABLET;ORAL~CARVEDILOL~ZYDUS PHARMS USA INC~25MG~A~077614~003~AB~Sep
BICALUTAMIDE~TABLET;ORAL~CASODEX~ASTRAZENECA~50MG~N~020498~001~AB~Oct 4, 1995~Ye
s~RX~ASTRAZENECA UK LTD
DICLOFENAC POTASSIUM~TABLET;ORAL~CATAFLAM~NOVARTIS~25MG **Federal Register deter
easons**~N~020142~001~~Nov 24, 1993~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
DICLOFENAC POTASSIUM~TABLET;ORAL~CATAFLAM~NOVARTIS~50MG~N~020142~002~AB~Nov 24,
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CATAPRES~BOEHRINGER INGELHEIM~0.1MG~N~017407
~001~AB~Approved Prior to Jan 1, 1982~No~RX~BOEHRINGER INGELHEIM
~002~AB~Approved Prior to Jan 1, 1982~No~RX~BOEHRINGER INGELHEIM
~003~AB~Approved Prior to Jan 1, 1982~Yes~RX~BOEHRINGER INGELHEIM
CEFADROXIL/CEFADROXIL HEMIHYDRATE~TABLET;ORAL~CEFADROXIL~HIKMA~EQ 1GM BASE~A~065
260~001~AB~Mar 30, 2006~No~RX~HIKMA PHARMACEUTICALS
CEFADROXIL/CEFADROXIL HEMIHYDRATE~TABLET;ORAL~CEFADROXIL~ORCHID HLTHCARE~EQ 1GM
BASE~A~065301~001~AB~Sep 18, 2006~No~RX~ORCHID HEALTHCARE
CEFADROXIL/CEFADROXIL HEMIHYDRATE~TABLET;ORAL~CEFADROXIL~RANBAXY~EQ 1GM BASE~A~0
65018~001~~Apr 23, 1999~No~DISCN~RANBAXY PHARMACEUTICALS INC
CEFADROXIL/CEFADROXIL HEMIHYDRATE~TABLET;ORAL~CEFADROXIL~TEVA PHARMS~EQ 1GM BASE
~A~062774~001~~Apr 8, 1987~Yes~RX~TEVA PHARMACEUTICALS USA
CEFPODOXIME PROXETIL~TABLET;ORAL~CEFPODOXIME PROXETIL~AUROBINDO PHARMA~EQ 100MG
BASE~A~065370~001~AB~Jun 11, 2007~No~RX~AUROBINDO PHARMA LTD

CEFPODOXIME PROXETIL~TABLET;ORAL~CEFPODOXIME PROXETIL~AUROBINDO PHARMA~EQ 200MG
BASE~A~065370~002~AB~Jun 11, 2007~No~RX~AUROBINDO PHARMA LTD
CEFPODOXIME PROXETIL~TABLET;ORAL~CEFPODOXIME PROXETIL~ORCHID HLTHCARE~EQ 100MG B
ASE~A~065388~001~AB~Nov 14, 2007~No~RX~ORCHID HEALTHCARE
CEFPODOXIME PROXETIL~TABLET;ORAL~CEFPODOXIME PROXETIL~ORCHID HLTHCARE~EQ 200MG B
ASE~A~065388~002~AB~Nov 14, 2007~No~RX~ORCHID HEALTHCARE
CEFPODOXIME PROXETIL~TABLET;ORAL~CEFPODOXIME PROXETIL~RANBAXY~EQ 100MG BASE~A~06
5083~001~AB~Aug 20, 2003~No~RX~RANBAXY LABORATORIES LTD
CEFPODOXIME PROXETIL~TABLET;ORAL~CEFPODOXIME PROXETIL~RANBAXY~EQ 200MG BASE~A~06
CEFPODOXIME PROXETIL~TABLET;ORAL~CEFPODOXIME PROXETIL~SANDOZ~EQ 100MG BASE~A~065
CEFPODOXIME PROXETIL~TABLET;ORAL~CEFPODOXIME PROXETIL~SANDOZ~EQ 200MG BASE~A~065
462~002~AB~May 28, 2008~Yes~RX~SANDOZ INC
CEFPROZIL~TABLET;ORAL~CEFPROZIL~APOTEX INC~250MG~A~065327~001~AB~Mar 26, 2008~No
~RX~APOTEX INC
CEFPROZIL~TABLET;ORAL~CEFPROZIL~APOTEX INC~500MG~A~065327~002~AB~Mar 26, 2008~No
~RX~APOTEX INC
CEFPROZIL~TABLET;ORAL~CEFPROZIL~AUROBINDO PHARMA LTD~250MG~A~065340~001~AB~May 2
4, 2007~No~RX~AUROBINDO PHARMA LTD INC
CEFPROZIL~TABLET;ORAL~CEFPROZIL~AUROBINDO PHARMA LTD~500MG~A~065340~002~AB~May 2
4, 2007~No~RX~AUROBINDO PHARMA LTD INC
CEFPROZIL~TABLET;ORAL~CEFPROZIL~LUPIN~250MG~A~065276~001~AB~Dec 8, 2005~No~RX~LU
PIN LTD
CEFPROZIL~TABLET;ORAL~CEFPROZIL~LUPIN~500MG~A~065276~002~AB~Dec 8, 2005~Yes~RX~L
UPIN LTD
CEFPROZIL~TABLET;ORAL~CEFPROZIL~ORCHID HLTHCARE~250MG~A~065267~001~AB~Dec 19, 20
CEFPROZIL~TABLET;ORAL~CEFPROZIL~ORCHID HLTHCARE~500MG~A~065267~002~AB~Dec 19, 20
CEFPROZIL~TABLET;ORAL~CEFPROZIL~RANBAXY LABS LTD~250MG~A~065198~001~~Dec 13, 200
CEFPROZIL~TABLET;ORAL~CEFPROZIL~RANBAXY LABS LTD~500MG~A~065198~002~~Dec 13, 200
CEFPROZIL~TABLET;ORAL~CEFPROZIL~SANDOZ~250MG~A~065235~001~AB~Nov 14, 2005~No~RX~
SANDOZ INC
CEFPROZIL~TABLET;ORAL~CEFPROZIL~SANDOZ~500MG~A~065235~002~AB~Nov 14, 2005~No~RX~
SANDOZ INC
CEFPROZIL~TABLET;ORAL~CEFPROZIL~TEVA~250MG~A~065208~001~AB~Dec 6, 2005~No~RX~TEV
CEFPROZIL~TABLET;ORAL~CEFPROZIL~TEVA~500MG~A~065208~002~AB~Dec 6, 2005~No~RX~TEV
CEFPROZIL~TABLET;ORAL~CEFPROZIL~WOCKHARDT~250MG~A~065428~001~AB~Jun 14, 2007~No~
RX~WOCKHARDT LTD
CEFPROZIL~TABLET;ORAL~CEFPROZIL~WOCKHARDT~500MG~A~065428~002~AB~Jun 14, 2007~No~
RX~WOCKHARDT LTD
CEFUROXIME AXETIL~TABLET;ORAL~CEFTIN~GLAXOSMITHKLINE~EQ 125MG BASE~N~050605~001~
AB~Dec 28, 1987~No~RX~GLAXOSMITHKLINE
AB~Dec 28, 1987~No~RX~GLAXOSMITHKLINE
AB~Dec 28, 1987~Yes~RX~GLAXOSMITHKLINE
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~ALKEM LABS LTD~EQ 250MG BASE~A~0
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~ALKEM LABS LTD~EQ 500MG BASE~A~0
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~APOTEX~EQ 250MG BASE~A~065069~00
1~AB~Oct 2, 2002~No~RX~APOTEX INC
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~APOTEX~EQ 500MG BASE~A~065069~00

CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~AUROBINDO PHARMA LTD~EQ 125MG BA
SE~A~065308~001~AB~Mar 29, 2006~No~RX~AUROBINDO PHARMA LTD INC
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~LUPIN~EQ 250MG BASE~A~065135~001
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~LUPIN~EQ 500MG BASE~A~065135~002
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~ORCHID HLTHCARE~EQ 125MG BASE~A~
065359~001~AB~Feb 15, 2008~No~RX~ORCHID HEALTHCARE
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~RANBAXY~EQ 125MG BASE~A~065118~0
01~AB~Apr 25, 2003~No~RX~RANBAXY LABORATORIES LTD
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~RANBAXY LABS LTD~EQ 125MG BASE~A
~065043~003~~Feb 15, 2002~No~DISCN~RANBAXY LABORATORIES LTD
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~SANDOZ~EQ 250MG BASE~A~065126~00
1~~Oct 28, 2003~No~DISCN~SANDOZ INC
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~SANDOZ~EQ 500MG BASE~A~065126~00
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~TEVA~EQ 250MG BASE~A~065190~001~
AB~Oct 18, 2004~No~RX~TEVA PHARMACEUTICALS USA INC
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~TEVA~EQ 500MG BASE~A~065190~002~
CEFUROXIME AXETIL~TABLET;ORAL~CEFUROXIME AXETIL~WOCKHARDT~EQ 125MG BASE~A~065166
~001~AB~Jul 29, 2005~No~RX~WOCKHARDT LTD
CEFPROZIL~TABLET;ORAL~CEFZIL~CORDEN PHARMA~250MG~N~050664~001~~Dec 23, 1991~No~D
ISCN~CORDEN PHARMA LATINA SPA
CEFPROZIL~TABLET;ORAL~CEFZIL~CORDEN PHARMA~500MG~N~050664~002~~Dec 23, 1991~No~D
ISCN~CORDEN PHARMA LATINA SPA
BETAMETHASONE~TABLET;ORAL~CELESTONE~SCHERING~0.6MG~N~012657~003~~Approved Prior
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CELEXA~FOREST LABS~EQ 10MG BASE~N~020822~001
~AB~Apr 27, 2000~No~RX~FOREST LABORATORIES INC
~AB~Jul 17, 1998~No~RX~FOREST LABORATORIES INC
~AB~Jul 17, 1998~Yes~RX~FOREST LABORATORIES INC
~~Jul 17, 1998~No~DISCN~FOREST LABORATORIES INC
MYCOPHENOLATE MOFETIL~TABLET;ORAL~CELLCEPT~ROCHE PALO~500MG~N~050723~001~AB~Jun
19, 1997~Yes~RX~ROCHE PALO ALTO LLC
ESTROGENS, CONJUGATED SYNTHETIC A~TABLET;ORAL~CENESTIN~TEVA BRANDED PHARM~0.3MG~
N~020992~001~~Jun 21, 2002~No~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D IN

C
ESTROGENS, CONJUGATED SYNTHETIC A~TABLET;ORAL~CENESTIN~TEVA BRANDED PHARM~0.45MG
~N~020992~005~~Feb 5, 2004~No~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D IN
C
ESTROGENS, CONJUGATED SYNTHETIC A~TABLET;ORAL~CENESTIN~TEVA BRANDED PHARM~0.625M
G~N~020992~002~~Mar 24, 1999~No~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D
INC
ESTROGENS, CONJUGATED SYNTHETIC A~TABLET;ORAL~CENESTIN~TEVA BRANDED PHARM~0.9MG~
N~020992~003~~Mar 24, 1999~No~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D IN
C
ESTROGENS, CONJUGATED SYNTHETIC A~TABLET;ORAL~CENESTIN~TEVA BRANDED PHARM~1.25MG
~N~020992~004~~Mar 13, 2000~Yes~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D
INC
PRAZEPAM~TABLET;ORAL~CENTRAX~PARKE DAVIS~10MG~N~017415~001~~Approved Prior to Ja
CEPHALEXIN~TABLET;ORAL~CEPHALEXIN~BARR~EQ 250MG BASE~A~062826~001~~Aug 17, 1987~
No~DISCN~BARR LABORATORIES INC
CEPHALEXIN~TABLET;ORAL~CEPHALEXIN~BARR~EQ 500MG BASE~A~062827~001~~Aug 17, 1987~
CEPHALEXIN~TABLET;ORAL~CEPHALEXIN~TEVA~EQ 250MG BASE~A~063023~001~~Jan 12, 1989~
CEPHALEXIN~TABLET;ORAL~CEPHALEXIN~TEVA~EQ 500MG BASE~A~063024~001~~Jan 12, 1989~
Yes~RX~TEVA PHARMACEUTICALS USA INC
CEPHALEXIN~TABLET;ORAL~CEPHALEXIN~VITARINE~EQ 1GM BASE~A~062863~003~~Aug 11, 198
8~No~DISCN~VITARINE PHARMACEUTICALS INC
CEPHALEXIN~TABLET;ORAL~CEPHALEXIN~VITARINE~EQ 250MG BASE~A~062863~001~~Aug 11, 1
CEPHALEXIN~TABLET;ORAL~CEPHALEXIN~VITARINE~EQ 500MG BASE~A~062863~002~~Aug 11, 1
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~ACTAVIS EL
IZABETH~5MG~A~078615~003~~Dec 28, 2007~No~DISCN~ACTAVIS ELIZABETH LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~ACTAVIS EL
IZABETH~10MG~A~078615~004~~Dec 28, 2007~No~DISCN~ACTAVIS ELIZABETH LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~AMNEAL PHA
RMS NY~5MG~A~078780~001~~Jan 21, 2010~No~OTC~AMNEAL PHARMACEUTICALS NY LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~AMNEAL PHA
RMS NY~10MG~A~078780~004~~Jan 21, 2010~No~OTC~AMNEAL PHARMACEUTICALS NY LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~APOTEX INC
~5MG~A~078317~001~~Dec 27, 2007~No~OTC~APOTEX INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~APOTEX INC
~10MG~A~078317~002~~Dec 27, 2007~No~OTC~APOTEX INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~CADISTA PH
ARMS~5MG~A~078933~001~~Jun 15, 2010~No~OTC~CADISTA PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~CADISTA PH
ARMS~10MG~A~078933~002~~Jun 15, 2010~No~OTC~CADISTA PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~CIPLA LTD~
5MG~A~077318~001~~Jul 25, 2013~No~OTC~CIPLA LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~CIPLA LTD~
10MG~A~077318~002~~Jul 25, 2013~No~OTC~CIPLA LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~CONTRACT P
HARMACAL~5MG~A~076047~001~~Dec 27, 2007~No~OTC~CONTRACT PHARMACAL CORP
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~CONTRACT P
HARMACAL~10MG~A~076047~002~~Dec 27, 2007~No~OTC~CONTRACT PHARMACAL CORP
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~DR REDDYS
LABS LTD~5MG~A~078343~004~~Jan 15, 2008~No~OTC~DR REDDYS LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~DR REDDYS
LABS LTD~10MG~A~078343~003~~Jan 15, 2008~No~OTC~DR REDDYS LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~IPCA LABS
LTD~5MG~A~202277~002~~Mar 11, 2014~No~OTC~IPCA LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~IPCA LABS

LTD~10MG~A~202277~004~~Mar 11, 2014~No~OTC~IPCA LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~MYLAN~5MG~
A~076677~001~~Dec 27, 2007~No~OTC~MYLAN PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~MYLAN~10MG
~A~076677~002~~Dec 27, 2007~No~OTC~MYLAN PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~ORCHID HLT
HCARE~5MG~A~078862~001~~Feb 19, 2009~No~OTC~ORCHID HEALTHCARE
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~ORCHID HLT
HCARE~10MG~A~078862~002~~Feb 19, 2009~No~OTC~ORCHID HEALTHCARE
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~PERRIGO R
AND D~5MG~A~078336~001~~Dec 27, 2007~No~OTC~PERRIGO R AND D CO
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~PERRIGO R
AND D~10MG~A~078336~002~~Dec 27, 2007~No~OTC~PERRIGO R AND D CO
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~RANBAXY~5M
G~A~077498~001~~Dec 27, 2007~No~OTC~RANBAXY LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~RANBAXY~10
MG~A~077498~002~~Dec 27, 2007~No~OTC~RANBAXY LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~SANDOZ~5MG
~A~077946~001~~Dec 27, 2007~No~OTC~SANDOZ INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~SANDOZ~10M
G~A~077946~002~~Dec 27, 2007~No~OTC~SANDOZ INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~SUN PHARM
INDS INC~5MG~A~077499~001~~Dec 27, 2007~No~OTC~SUN PHARMACEUTICAL INDUSTRIES INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~SUN PHARM
INDS INC~10MG~A~077499~002~~Dec 27, 2007~No~OTC~SUN PHARMACEUTICAL INDUSTRIES IN
C
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~TARO~5MG~A
~078072~001~~Jul 22, 2009~No~OTC~TARO PHARMACEUTICAL INDUSTRIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~TARO~5MG~A
~078072~003~~Jul 22, 2009~No~OTC~TARO PHARMACEUTICAL INDUSTRIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~TORRENT PH
ARMS LLC~5MG~A~079191~001~~Apr 15, 2010~No~OTC~TORRENT PHARMACEUTICALS LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~TORRENT PH
ARMS LLC~10MG~A~079191~004~~Apr 15, 2010~No~OTC~TORRENT PHARMACEUTICALS LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~UNICHEM~5M
G~A~078680~003~~Jun 26, 2009~No~OTC~UNICHEM LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~UNICHEM~10
MG~A~078680~004~~Jun 26, 2009~No~OTC~UNICHEM LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~UNIQUE PHA
RM LABS~5MG~A~077829~001~~Aug 26, 2009~No~OTC~UNIQUE PHARMACEUTICAL LABORATORIES
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~UNIQUE PHA
RM LABS~10MG~A~077829~004~~Aug 26, 2009~No~OTC~UNIQUE PHARMACEUTICAL LABORATORIE
S
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~WOCKHARDT~
5MG~A~078427~003~~Dec 28, 2007~No~OTC~WOCKHARDT LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE ALLERGY~WOCKHARDT~
10MG~A~078427~004~~Dec 28, 2007~No~OTC~WOCKHARDT LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~CADISTA PHAR
MS~5MG~A~078933~003~~Jun 15, 2010~No~OTC~CADISTA PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~CADISTA PHAR
MS~10MG~A~078933~004~~Jun 15, 2010~No~OTC~CADISTA PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~DR REDDYS LA
BS LTD~5MG~A~078343~001~~Jan 15, 2008~No~OTC~DR REDDYS LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~DR REDDYS LA
BS LTD~10MG~A~078343~002~~Jan 15, 2008~No~OTC~DR REDDYS LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~IPCA LABS LT
D~5MG~A~202277~001~~Mar 11, 2014~No~OTC~IPCA LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~IPCA LABS LT
D~10MG~A~202277~003~~Mar 11, 2014~No~OTC~IPCA LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~MYLAN~5MG~A~

076677~004~~Dec 27, 2007~No~OTC~MYLAN PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~MYLAN~10MG~A
~076677~003~~Dec 27, 2007~No~OTC~MYLAN PHARMACEUTICALS INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~ORCHID HLTHC
ARE~5MG~A~078862~003~~Feb 19, 2009~No~OTC~ORCHID HEALTHCARE
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~ORCHID HLTHC
ARE~10MG~A~078862~004~~Feb 19, 2009~No~OTC~ORCHID HEALTHCARE
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~PERRIGO R AN
D D~5MG~A~078336~003~~Dec 27, 2007~No~OTC~PERRIGO R AND D CO
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~PERRIGO R AN
D D~10MG~A~078336~004~~Dec 27, 2007~No~OTC~PERRIGO R AND D CO
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~RANBAXY~5MG~
A~077498~003~~Dec 27, 2007~No~OTC~RANBAXY LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~RANBAXY~10MG
~A~077498~004~~Dec 27, 2007~No~OTC~RANBAXY LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~SUN PHARM IN
DS INC~5MG~A~077499~003~~Dec 27, 2007~No~OTC~SUN PHARMACEUTICAL INDUSTRIES INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~SUN PHARM IN
DS INC~10MG~A~077499~004~~Dec 27, 2007~No~OTC~SUN PHARMACEUTICAL INDUSTRIES INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~UNICHEM~5MG~
A~078680~001~~Jun 26, 2009~No~OTC~UNICHEM LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~UNICHEM~10MG
~A~078680~002~~Jun 26, 2009~No~OTC~UNICHEM LABORATORIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~UNIQUE PHARM
LABS~5MG~A~077829~003~~Aug 26, 2009~No~OTC~UNIQUE PHARMACEUTICAL LABORATORIES
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES~UNIQUE PHARM
LABS~10MG~A~077829~002~~Aug 26, 2009~No~OTC~UNIQUE PHARMACEUTICAL LABORATORIES
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RELIEF~AMNEA
L PHARMS NY~5MG~A~078780~003~~Jan 21, 2010~No~OTC~AMNEAL PHARMACEUTICALS NY LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RELIEF~AMNEA
L PHARMS NY~10MG~A~078780~002~~Jan 21, 2010~No~OTC~AMNEAL PHARMACEUTICALS NY LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RELIEF~TARO~
10MG~A~078072~002~~Jul 22, 2009~No~OTC~TARO PHARMACEUTICAL INDUSTRIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RELIEF~TARO~
10MG~A~078072~004~~Jul 22, 2009~No~OTC~TARO PHARMACEUTICAL INDUSTRIES LTD
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RELIEF~TORRE
NT PHARMS LLC~5MG~A~079191~003~~Apr 15, 2010~No~OTC~TORRENT PHARMACEUTICALS LLC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~CETIRIZINE HYDROCHLORIDE HIVES RELIEF~TORRE
NT PHARMS LLC~10MG~A~079191~002~~Apr 15, 2010~No~OTC~TORRENT PHARMACEUTICALS LLC
VARENICLINE TARTRATE~TABLET;ORAL~CHANTIX~PFIZER INC~EQ 0.5MG BASE~N~021928~001~~
May 10, 2006~No~RX~PFIZER INC
VARENICLINE TARTRATE~TABLET;ORAL~CHANTIX~PFIZER INC~EQ 1MG BASE~N~021928~002~~Ma
y 10, 2006~Yes~RX~PFIZER INC
CHENODIOL~TABLET;ORAL~CHENIX~SIGMA TAU~250MG~N~018513~002~~Jul 28, 1983~No~DISCN
~SIGMA TAU PHARMACEUTICALS INC
CHENODIOL~TABLET;ORAL~CHENODIOL~NEXGEN PHARMA~250MG~A~091019~001~~Oct 22, 2009~Y
es~RX~NEXGEN PHARMA INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~CHILDREN'S ALLEGRA ALLERGY~SANOFI AVENTIS
US~30MG~N~020872~005~~Jan 24, 2011~No~OTC~SANOFI AVENTIS US LLC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~CHILDREN'S ALLEGRA HIVES~SANOFI AVENTIS U
S~30MG~N~020872~006~~Jan 24, 2011~No~OTC~SANOFI AVENTIS US LLC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALL
ERGY~AUROLIFE PHARMA LLC~30MG~A~202039~001~~Nov 19, 2014~No~OTC~AUROLIFE PHARMA
LLC
ERGY~DR REDDYS LABS LTD~30MG~A~076502~004~~Apr 12, 2011~No~OTC~DR REDDYS LABORAT
ORIES LTD
ERGY~MYLAN~30MG~A~077081~004~~Jul 21, 2011~No~OTC~MYLAN PHARMACEUTICALS INC

ERGY~SUN PHARM INDS~30MG~A~091567~002~~Feb 6, 2012~No~OTC~SUN PHARMACEUTICAL IND
USTRIES LTD
ERGY~TEVA~30MG~A~076447~004~~Apr 13, 2011~No~OTC~TEVA PHARMACEUTICALS USA INC
ERGY~WOCKHARDT LTD~30MG~A~079112~002~~Feb 8, 2012~No~OTC~WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIV
ES~DR REDDYS LABS LTD~30MG~A~076502~005~~Apr 12, 2011~No~OTC~DR REDDYS LABORATOR
IES LTD
ES~MYLAN~30MG~A~077081~005~~Jul 21, 2011~No~OTC~MYLAN PHARMACEUTICALS INC
ES~SUN PHARM INDS~30MG~A~091567~001~~Feb 6, 2012~No~OTC~SUN PHARMACEUTICAL INDUS
TRIES LTD
ES~TEVA~30MG~A~076447~005~~Apr 13, 2011~No~OTC~TEVA PHARMACEUTICALS USA INC
ES~WOCKHARDT LTD~30MG~A~079112~001~~Feb 8, 2012~No~OTC~WOCKHARDT LTD
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLOR-TRIMETON~SCHERING~4MG~N~006921~002~~A
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE~TABLET;ORAL~CHLORDIAZEPOXIDE AND A
MITRIPTYLINE HYDROCHLORIDE~MUTUAL PHARM~EQ 12.5MG BASE;5MG~A~070765~001~~Dec 10,
MITRIPTYLINE HYDROCHLORIDE~MUTUAL PHARM~EQ 25MG BASE;10MG~A~070766~001~~Dec 10,
MITRIPTYLINE HYDROCHLORIDE~MYLAN PHARMS INC~EQ 12.5MG BASE;5MG~A~071297~002~~Dec
MITRIPTYLINE HYDROCHLORIDE~MYLAN PHARMS INC~EQ 25MG BASE;10MG~A~071297~001~~Dec
10, 1986~Yes~RX~MYLAN PHARMACEUTICALS INC
MITRIPTYLINE HYDROCHLORIDE~PAR PHARM~EQ 12.5MG BASE;5MG~A~072277~001~~May 9, 198
MITRIPTYLINE HYDROCHLORIDE~PAR PHARM~EQ 25MG BASE;10MG~A~072278~001~~May 9, 1988
~No~DISCN~PAR PHARMACEUTICAL INC
MITRIPTYLINE HYDROCHLORIDE~USL PHARMA~EQ 12.5MG BASE;5MG~A~070477~001~~Jan 12, 1
MITRIPTYLINE HYDROCHLORIDE~USL PHARMA~EQ 25MG BASE;10MG~A~070478~001~~Jan 12, 19
MITRIPTYLINE HYDROCHLORIDE~WATSON LABS~EQ 12.5MG BASE;5MG~A~072052~001~~Dec 16,
MITRIPTYLINE HYDROCHLORIDE~WATSON LABS~EQ 25MG BASE;10MG~A~072053~001~~Dec 16, 1
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~HIKMA PHARMS LLC~EQ 150M
G BASE~A~083082~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA PHARMACEUTICAL
S LLC
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~HIKMA PHARMS LLC~EQ 300M
G BASE~A~083082~002~AA~Sep 17, 1999~No~RX~HIKMA PHARMACEUTICALS LLC
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~IMPAX LABS~EQ 150MG BASE
~A~080880~001~AA~Approved Prior to Jan 1, 1982~No~RX~IMPAX LABORATORIES INC
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~IMPAX LABS~EQ 300MG BASE
~A~040516~001~AA~Aug 29, 2003~No~RX~IMPAX LABORATORIES INC
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~IPCA LABS LTD~EQ 150MG B

ASE~A~090610~001~AA~Dec 3, 2009~No~RX~IPCA LABORATORIES LTD
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~IPCA LABS LTD~EQ 300MG B
ASE~A~090249~001~AA~Dec 3, 2009~No~RX~IPCA LABORATORIES LTD
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~MD PHARM~EQ 150MG BASE~A
~087228~001~~Approved Prior to Jan 1, 1982~No~DISCN~MD PHARMACEUTICAL INC
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~NATCO PHARMA LTD~EQ 150M
G BASE~A~091621~001~AA~Jan 21, 2011~No~RX~NATCO PHARMA LIMITED
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~NATCO PHARMA LTD~EQ 300M
G BASE~A~090612~001~AA~Jan 21, 2011~No~RX~NATCO PHARMA LTD
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~PUREPAC PHARM~EQ 150MG B
ASE~A~080886~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL
CO
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~TEVA~EQ 150MG BASE~A~087
504~001~~Jan 13, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~WATSON LABS~EQ 150MG BAS
E~A~087979~001~~Dec 21, 1982~No~DISCN~WATSON LABORATORIES INC
CHLOROQUINE PHOSPHATE~TABLET;ORAL~CHLOROQUINE PHOSPHATE~WATSON LABS~EQ 300MG BAS
E~A~088030~001~~Dec 21, 1982~No~DISCN~WATSON LABORATORIES INC
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~ABC HOLDING~250MG~A~085569~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ABC HOLDING CORP
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~HIKMA INTL PHARMS~250MG~A~086028~001~~
Jul 14, 1982~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~HIKMA INTL PHARMS~500MG~A~087736~001~~
Jul 14, 1982~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~LEDERLE~250MG~A~086940~001~~Approved P
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~LEDERLE~500MG~A~086938~001~~Approved P
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~MYLAN~250MG~A~084388~001~~Approved Pri
or to Jan 1, 1982~Yes~RX~MYLAN PHARMACEUTICALS INC
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~MYLAN~500MG~A~084217~001~~Approved Pri
or to Jan 1, 1982~No~RX~MYLAN PHARMACEUTICALS INC
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~SANDOZ~250MG~A~085485~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~SANDOZ INC
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~WATSON LABS~250MG~A~085165~001~~Approv
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~WATSON LABS~250MG~A~085173~001~~Approv
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~WATSON LABS~250MG~A~086795~001~~Aug 15
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~WATSON LABS~500MG~A~084026~001~~Sep 1,
CHLOROTHIAZIDE~TABLET;ORAL~CHLOROTHIAZIDE~WATSON LABS~500MG~A~086796~001~~Aug 15
CHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~CHLOROTHIAZIDE AND RESERPINE~HIKMA PHARMS
LLC~250MG;0.125MG~A~088557~001~~Dec 22, 1983~No~DISCN~HIKMA PHARMACEUTICALS LLC
CHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~CHLOROTHIAZIDE AND RESERPINE~HIKMA PHARMS
LLC~500MG;0.125MG~A~088365~001~~Dec 22, 1983~No~DISCN~HIKMA PHARMACEUTICALS LLC
CHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~CHLOROTHIAZIDE W/ RESERPINE~WATSON LABS~25
0MG;0.125MG~A~084853~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATO
RIES INC
CHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~CHLOROTHIAZIDE W/ RESERPINE~WATSON LABS~50
0MG;0.125MG~A~088151~001~~Jun 9, 1983~No~DISCN~WATSON LABORATORIES INC
CHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~CHLOROTHIAZIDE-RESERPINE~MYLAN~250MG;0.125
MG~A~087744~001~~May 6, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
CHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~CHLOROTHIAZIDE-RESERPINE~MYLAN~500MG;0.125
MG~A~087745~001~~May 6, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~ANABOLIC~4MG~A~083
078~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANABOLIC INC
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~BELL PHARMA~4MG~A~

083062~001~~Approved Prior to Jan 1, 1982~No~DISCN~BELL PHARMACAL CORP
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~ELKINS SINN~4MG~A~
080938~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO
INC
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~IMPAX LABS~4MG~A~0
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~IVAX SUB TEVA PHAR
MS~4MG~A~080779~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~KV PHARM~4MG~A~087
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~LEDERLE~4MG~A~0869
CYANAMID CO
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~MUTUAL PHARM~4MG~A
~080700~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~NEWTRON PHARMS~4MG
~A~086519~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEWTRON PHARMACEUTICALS IN
C
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~PANRAY~4MG~A~08324
3~001~~Approved Prior to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CH
EMICAL CO INC
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~PHARMAVITE~4MG~A~0
85104~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMAVITE PHARMACEUTICALS
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~PHARMERAL~4MG~A~08
3753~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMERAL INC
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~PIONEER PHARMS~4MG
~A~088556~001~~Jul 13, 1984~No~DISCN~PIONEER PHARMACEUTICALS INC
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~PUREPAC PHARM~4MG~
A~086306~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~PVT FORM~4MG~A~080
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~ROXANE~4MG~A~08062
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~SANDOZ~4MG~A~08096
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~VITARINE~4MG~A~085
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~WATSON LABS~4MG~A~
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~CHLORPHENIRAMINE MALEATE~WEST WARD~4MG~A~08
3787~001~~Approved Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~ABBOTT~10M
G~A~084414~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARM
ACEUTICAL PRODUCTS DIV
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~ABBOTT~100
MG~A~084412~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHAR
MACEUTICAL PRODUCTS DIV
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~ABBOTT~200
MG~A~084413~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHAR

MACEUTICAL PRODUCTS DIV
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~IVAX SUB T
EVA PHARMS~100MG~A~083574~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARM
ACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
EVA PHARMS~200MG~A~083575~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARM
ACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~KV PHARM~1
0MG~A~085750~002~~Jan 4, 1982~No~DISCN~KV PHARMACEUTICAL CO
5MG~A~085751~001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
00MG~A~085748~002~~Jan 4, 1982~No~DISCN~KV PHARMACEUTICAL CO
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~LEDERLE~10
MG~A~084803~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV
0MG~A~084789~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DI
V AMERICAN CYANAMID CO
0MG~A~084802~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DI
V AMERICAN CYANAMID CO
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~PUREPAC PH
ARM~10MG~A~080403~004~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUT
ICAL CO
ICAL CO
ICAL CO
ARM~100MG~A~080403~003~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEU
TICAL CO
ARM~200MG~A~080403~005~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEU
TICAL CO
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~PVT FORM~2
5MG~A~080340~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS IN
C

0MG~A~080340~002~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS IN
C
00MG~A~080340~003~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS I
NC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~ROXANE~10M
G~A~085331~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~ROXANE~100
MG~A~085331~004~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~ROXANE~200
MG~A~085331~005~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~SANDOZ~10M
G~A~080439~001~BP~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~SANDOZ~100
MG~A~080439~004~BP~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~SANDOZ~200
MG~A~080439~005~BP~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~USL PHARMA
~10MG~A~083386~001~BP~Approved Prior to Jan 1, 1982~No~RX~USL PHARMA INC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~VANGARD~10
MG~A~088038~001~~Aug 16, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDIC
AL CO
MG~A~087645~001~~Approved Prior to Jan 1, 1982~No~DISCN~VANGARD LABORATORIES INC
DIV MIDWAY MEDICAL CO
MG~A~087646~001~~Approved Prior to Jan 1, 1982~No~DISCN~VANGARD LABORATORIES INC
DIV MIDWAY MEDICAL CO
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~WATSON LAB
S~10MG~A~085959~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES
INC
INC
INC
INC
INC
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~CHLORPROMAZINE HYDROCHLORIDE~WEST WARD~

10MG~A~087783~001~~Sep 16, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~ANI PHARMS INC~100MG~A~088768~001~~Oct
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~ANI PHARMS INC~100MG~A~088921~001~AB~A
pr 12, 1985~No~RX~ANI PHARMACEUTICALS INC
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~ANI PHARMS INC~100MG~A~089446~001~~Nov
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~ANI PHARMS INC~250MG~A~088922~001~AB~A
pr 12, 1985~No~RX~ANI PHARMACEUTICALS INC
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~ANI PHARMS INC~250MG~A~089447~001~~Nov
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~DAVA PHARMS INC~100MG~A~089561~001~~Se
p 4, 1987~No~DISCN~DAVA PHARMACEUTICALS INC
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~DAVA PHARMS INC~250MG~A~089562~001~~Se
p 4, 1987~No~DISCN~DAVA PHARMACEUTICALS INC
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~HALSEY~100MG~A~089321~001~~Jan 16, 198
6~No~DISCN~HALSEY DRUG CO INC
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~HALSEY~250MG~A~088662~001~~Jan 9, 1986
~No~DISCN~HALSEY DRUG CO INC
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~MYLAN~100MG~A~088549~002~AB~Jun 1, 198
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~MYLAN~250MG~A~088549~001~AB~Jun 1, 198
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~PAR PHARM~100MG~A~088175~001~~Feb 27,
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~PAR PHARM~250MG~A~088176~001~~Feb 27,
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~SANDOZ~100MG~A~088725~001~~Aug 31, 198
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~SANDOZ~250MG~A~084669~001~~Approved Pr
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~SANDOZ~250MG~A~088726~001~~Aug 31, 198
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~SUPERPHARM~100MG~A~088694~001~~Sep 17,
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~SUPERPHARM~250MG~A~088695~001~~Sep 17,
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~TEVA PHARMS USA~250MG~A~087353~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~USL PHARMA~100MG~A~088708~001~~Aug 30,
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~USL PHARMA~250MG~A~088709~001~~Aug 30,

CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~WATSON LABS~100MG~A~086865~001~~Sep 24
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~WATSON LABS~100MG~A~088608~001~~Apr 12
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~WATSON LABS~250MG~A~086866~001~~Approv
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~WATSON LABS~250MG~A~088568~001~~Apr 12
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~WATSON LABS INC~100MG~A~088852~001~~Se
CHLORPROPAMIDE~TABLET;ORAL~CHLORPROPAMIDE~WATSON LABS INC~250MG~A~088826~001~~Se
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~ABBOTT~25MG~A~087364~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~ABBOTT~50MG~A~087384~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~ASCOT~25MG~A~087698~001~~Oct 20, 1982~
No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~ASCOT~50MG~A~087699~001~~Oct 20, 1982~
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~BARR LABS INC~25MG~A~088902~001~~Sep 1
9, 1985~No~DISCN~BARR LABORATORIES INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~BARR LABS INC~50MG~A~088903~001~~Sep 1
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~DAVA PHARMS INC~25MG~A~087451~001~~App
roved Prior to Jan 1, 1982~No~DISCN~DAVA PHARMACEUTICALS INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~DAVA PHARMS INC~50MG~A~087450~001~~App
roved Prior to Jan 1, 1982~No~DISCN~DAVA PHARMACEUTICALS INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~IVAX PHARMS~25MG~A~087555~001~~Approve
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~IVAX PHARMS~25MG~A~088164~001~~Jan 9,
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~IVAX PHARMS~50MG~A~087176~001~~Approve
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~IVAX PHARMS~50MG~A~087947~001~~Feb 27,
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~KV PHARM~25MG~A~087311~001~~Approved P
rior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~KV PHARM~50MG~A~087312~001~~Approved P
rior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~MUTUAL PHARM~25MG~A~087292~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~MUTUAL PHARM~25MG~A~089285~001~~Jul 21
, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~MUTUAL PHARM~25MG~A~089738~001~~Sep 19
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~MUTUAL PHARM~50MG~A~087293~001~~Approv
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~MUTUAL PHARM~50MG~A~089286~001~~Jul 21
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~MUTUAL PHARM~50MG~A~089739~001~~Sep 19
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~MYLAN~25MG~A~086831~002~~Approved Prio
r to Jan 1, 1982~No~RX~MYLAN PHARMACEUTICALS INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~MYLAN~50MG~A~086831~001~~Approved Prio
r to Jan 1, 1982~Yes~RX~MYLAN PHARMACEUTICALS INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~PIONEER PHARMS~50MG~A~089591~001~~Jul
21, 1988~No~DISCN~PIONEER PHARMACEUTICALS INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~PUREPAC PHARM~25MG~A~088139~001~~Jul 1
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~PUREPAC PHARM~50MG~A~088140~001~~Aug 1
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~SANDOZ~25MG~A~087380~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~SANDOZ INC
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~SUPERPHARM~25MG~A~087473~001~~Feb 9, 1
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~SUPERPHARM~50MG~A~087247~001~~Feb 9, 1
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~TEVA~50MG~A~088651~001~~May 30, 1985~N
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~USL PHARMA~25MG~A~089051~001~~Jun 1, 1
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~USL PHARMA~50MG~A~089052~001~~Jun 1, 1
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~VANGARD~25MG~A~088012~001~~Jul 14, 198
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~VANGARD~50MG~A~088073~001~~Mar 25, 198
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~WARNER CHILCOTT~25MG~A~087515~001~~Jan
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~WARNER CHILCOTT~50MG~A~087516~001~~Feb
CHLORTHALIDONE~TABLET;ORAL~CHLORTHALIDONE~WATSON LABS~25MG~A~087050~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~ACTAVIS ELIZABETH~250MG~A~088928~001~~Ma
y 8, 1987~No~DISCN~ACTAVIS ELIZABETH LLC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~ACTAVIS ELIZABETH~500MG~A~040113~001~~Se
p 29, 1995~No~DISCN~ACTAVIS ELIZABETH LLC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~BARR~500MG~A~089895~001~AA~May 4, 1988~N
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~MIKART~375MG~A~040861~001~~Jun 1, 2010~N
o~RX~MIKART INC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~MIKART~750MG~A~040861~002~~Jun 1, 2010~N
o~RX~MIKART INC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~MUTUAL PHARM~500MG~A~089970~001~~Sep 27,
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~OHM LABS~250MG~A~081298~001~~Dec 29, 199
3~No~DISCN~OHM LABORATORIES INC.
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~OHM LABS~500MG~A~081299~001~~Dec 29, 199
3~No~DISCN~OHM LABORATORIES INC.
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~PAR PHARM~250MG~A~087981~001~~Sep 20, 19

CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~PIONEER PHARMS~250MG~A~089592~001~~Jan 6
, 1989~No~DISCN~PIONEER PHARMACEUTICALS INC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~PIONEER PHARMS~500MG~A~089948~001~~Jan 6
, 1989~No~DISCN~PIONEER PHARMACEUTICALS INC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~SANDOZ~250MG~A~089852~001~~May 4, 1988~N
o~DISCN~SANDOZ INC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~SANDOZ~500MG~A~089853~001~~May 4, 1988~N
o~DISCN~SANDOZ INC
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~WATSON LABS~250MG~A~086901~001~~Approved
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~WATSON LABS~250MG~A~086948~001~~Aug 9, 1
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~WATSON LABS~500MG~A~040137~001~~Aug 9, 1
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~WATSON LABS~500MG~A~081019~001~~Jul 29,
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~WATSON LABS~500MG~A~081040~001~~Aug 22,
CHLORZOXAZONE~TABLET;ORAL~CHLORZOXAZONE~WATSON LABS~500MG~A~089859~001~AA~May 4,
IOCETAMIC ACID~TABLET;ORAL~CHOLEBRINE~MALLINCKRODT~750MG~N~017129~001~~Approved
Prior to Jan 1, 1982~No~DISCN~MALLINCKRODT MEDICAL INC
DEXTROTHYROXINE SODIUM~TABLET;ORAL~CHOLOXIN~ABBVIE~1MG~N~012302~005~~Approved Pr
TADALAFIL~TABLET;ORAL~CIALIS~LILLY~2.5MG~N~021368~004~~Jan 7, 2008~No~RX~ELI LIL
LY AND CO
TADALAFIL~TABLET;ORAL~CIALIS~LILLY~5MG~N~021368~001~~Nov 21, 2003~No~RX~ELI LILL
Y AND CO
TADALAFIL~TABLET;ORAL~CIALIS~LILLY~10MG~N~021368~002~~Nov 21, 2003~No~RX~ELI LIL
LY AND CO
TADALAFIL~TABLET;ORAL~CIALIS~LILLY~20MG~N~021368~003~~Nov 21, 2003~Yes~RX~ELI LI
LLY AND CO
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~ACTAVIS ELIZABETH~100MG~A~077028~002~~Nov 26,
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~APOTEX INC~50MG~A~077030~001~AB~Dec 10, 2004~N
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~APOTEX INC~100MG~A~077030~002~AB~Dec 10, 2004~
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~BIOKEY~50MG~A~077722~001~AB~Sep 24, 2012~No~RX
~BIOKEY INC
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~BIOKEY~100MG~A~077831~001~AB~Sep 24, 2012~No~R
X~BIOKEY INC
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~BRECKENRIDGE PHARM~50MG~A~077708~001~AB~Sep 28
, 2009~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~BRECKENRIDGE PHARM~100MG~A~077708~002~AB~Sep 2
8, 2009~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~COREPHARMA~50MG~A~077150~001~~Mar 11, 2005~No~
DISCN~COREPHARMA LLC
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~COREPHARMA~100MG~A~077022~001~~Nov 23, 2004~No
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~IVAX SUB TEVA PHARMS~100MG~A~077020~002~~Mar 1
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~MUTUAL PHARM~50MG~A~077208~002~~Mar 29, 2006~N

o~DISCN~MUTUAL PHARMACEUTICAL CO INC
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~MUTUAL PHARM~100MG~A~077208~001~~Mar 29, 2006~
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~MYLAN~50MG~A~077323~002~AB~Apr 20, 2006~No~RX~
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~MYLAN~100MG~A~077323~001~AB~Apr 20, 2006~No~RX
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~MYLAN PHARMS INC~50MG~A~077019~001~AB~Nov 23,
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~MYLAN PHARMS INC~100MG~A~077019~002~AB~Nov 23,
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~PLIVA HRVATSKA DOO~50MG~A~077898~001~AB~Oct 29
, 2007~No~RX~PLIVA HRVATSKA DOO
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~PLIVA HRVATSKA DOO~100MG~A~077898~002~AB~Oct 2
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~ROXANE~50MG~A~077024~001~AB~May 17, 2005~No~RX
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~ROXANE~100MG~A~077024~002~AB~May 17, 2005~No~R
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~SANDOZ~50MG~A~077310~001~AB~Nov 8, 2005~No~RX~
SANDOZ INC
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~SANDOZ~100MG~A~077021~001~AB~Nov 23, 2004~No~R
X~SANDOZ INC
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~TEVA~50MG~A~077027~001~AB~Nov 24, 2004~No~RX~T
CILOSTAZOL~TABLET;ORAL~CILOSTAZOL~TEVA~100MG~A~077027~002~AB~Nov 24, 2004~No~RX~
CIMETIDINE~TABLET;ORAL~CIMETIDINE~APOTEX~100MG~A~074948~001~~Jun 19, 1998~No~OTC
~APOTEX INC
CIMETIDINE~TABLET;ORAL~CIMETIDINE~APOTEX~200MG~A~074890~001~AB~Dec 18, 1998~No~R
X~APOTEX INC
CIMETIDINE~TABLET;ORAL~CIMETIDINE~APOTEX~200MG~A~074948~002~~Jul 26, 2002~No~OTC
~APOTEX INC
X~APOTEX INC
X~APOTEX INC
X~APOTEX INC
CIMETIDINE~TABLET;ORAL~CIMETIDINE~CONTRACT PHARMACAL~200MG~A~074961~001~~Jun 19,
1998~No~OTC~CONTRACT PHARMACAL CORP
CIMETIDINE~TABLET;ORAL~CIMETIDINE~CONTRACT PHARMACAL~200MG~A~074963~001~~Jun 19,
CIMETIDINE~TABLET;ORAL~CIMETIDINE~CYCLE PHARMS LTD~300MG~A~074361~001~~Dec 23, 1
CIMETIDINE~TABLET;ORAL~CIMETIDINE~DAVA PHARMS INC~300MG~A~074340~001~~Jun 23, 19
CIMETIDINE~TABLET;ORAL~CIMETIDINE~IVAX SUB TEVA PHARMS~200MG~A~074401~001~~May 3
CIMETIDINE~TABLET;ORAL~CIMETIDINE~IVAX SUB TEVA PHARMS~200MG~A~074424~001~~Jul 2
CIMETIDINE~TABLET;ORAL~CIMETIDINE~IVAX SUB TEVA PHARMS~200MG~A~075345~001~~Jun 1

6, 1999~No~OTC~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CIMETIDINE~TABLET;ORAL~CIMETIDINE~LEK PHARMS~100MG~A~075122~001~~Jun 19, 1998~No
~DISCN~LEK PHARMACEUTICALS D D
CIMETIDINE~TABLET;ORAL~CIMETIDINE~MYLAN~200MG~A~074246~001~AB~May 17, 1994~No~RX
CIMETIDINE~TABLET;ORAL~CIMETIDINE~MYLAN~800MG~A~074246~004~AB~May 17, 1994~Yes~R
CIMETIDINE~TABLET;ORAL~CIMETIDINE~PERRIGO~100MG~A~074972~001~~Jun 19, 1998~No~DI
SCN~L PERRIGO CO
CIMETIDINE~TABLET;ORAL~CIMETIDINE~PERRIGO~200MG~A~075285~001~~Oct 29, 1998~No~OT
C~PERRIGO CO
CIMETIDINE~TABLET;ORAL~CIMETIDINE~PLIVA~200MG~A~074568~001~~Feb 27, 1997~No~DISC
N~PLIVA INC
N~PLIVA INC
N~PLIVA INC
CIMETIDINE~TABLET;ORAL~CIMETIDINE~PLIVA~800MG~A~074566~001~AB~Feb 27, 1997~No~RX
~PLIVA INC
CIMETIDINE~TABLET;ORAL~CIMETIDINE~SANDOZ~200MG~A~074100~001~~Jan 31, 1995~No~DIS
CN~SANDOZ INC
CN~SANDOZ INC
CN~SANDOZ INC
CN~SANDOZ INC
CN~SANDOZ INC
CN~SANDOZ INC
CN~SANDOZ INC

CN~SANDOZ INC
CIMETIDINE~TABLET;ORAL~CIMETIDINE~TEVA~200MG~A~074151~001~AB~May 17, 1994~No~RX~
CIMETIDINE~TABLET;ORAL~CIMETIDINE~TEVA~200MG~A~074365~001~~Feb 28, 1995~No~DISCN
CIMETIDINE~TABLET;ORAL~CIMETIDINE~VINTAGE PHARMS LLC~200MG~A~074281~001~~May 17,
CIMETIDINE~TABLET;ORAL~CIMETIDINE~WATSON LABS~200MG~A~075425~001~~Jul 29, 1999~N
CIMETIDINE~TABLET;ORAL~CIMETIDINE~WATSON LABS INC~200MG~A~074349~001~~Aug 30, 19
CIMETIDINE~TABLET;ORAL~CIMETIDINE~WATSON LABS INC~800MG~A~074316~001~~Feb 28, 19
QUINIDINE SULFATE~TABLET;ORAL~CIN-QUIN~SOLVAY~100MG~A~085299~001~~Approved Prior
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPRO~BAYER HLTHCARE~EQ 100MG BASE~N~019
537~001~AB~Apr 8, 1996~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
537~002~AB~Oct 22, 1987~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
537~003~AB~Oct 22, 1987~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
537~004~AB~Oct 22, 1987~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~APOTEX~EQ 25
0MG BASE~A~076896~001~AB~Nov 4, 2004~No~RX~APOTEX INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~AUROBINDO PH
ARMA~EQ 250MG BASE~A~077859~001~AB~Apr 26, 2007~No~RX~AUROBINDO PHARMA LTD

CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~BARR~EQ 250M
G BASE~A~074124~001~~Jun 9, 2004~No~DISCN~BARR LABORATORIES INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~CARLSBAD~EQ
250MG BASE~A~076126~002~AB~Jun 9, 2004~No~RX~CARLSBAD TECHNOLOGY INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~DR REDDYS LA
BS LTD~EQ 100MG BASE~A~075593~002~AB~Jun 9, 2004~No~RX~DR REDDYS LABORATORIES LT
D
D
D
D
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~HIKMA~EQ 250
MG BASE~A~076558~002~AB~Jun 9, 2004~No~RX~HIKMA PHARMACEUTICALS
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~IVAX SUB TEV
A PHARMS~EQ 250MG BASE~A~076089~002~AB~Jun 9, 2004~No~RX~IVAX PHARMACEUTICALS IN
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~MYLAN~EQ 100
MG BASE~A~075817~001~AB~Jun 25, 2007~No~RX~MYLAN PHARMACEUTICALS INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~NOSTRUM LABS
~EQ 250MG BASE~A~076138~001~~Jun 9, 2004~No~DISCN~NOSTRUM LABORATORIES INC

CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~PLIVA~EQ 100
MG BASE~A~076426~001~~Jun 15, 2005~No~DISCN~PLIVA INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~RANBAXY~EQ 2
50MG BASE~A~075747~001~AB~Jun 9, 2004~No~RX~RANBAXY PHARMACEUTICALS INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~SANDOZ~EQ 10
0MG BASE~A~075939~001~~Mar 3, 2005~No~DISCN~SANDOZ INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~TARO~EQ 100M
G BASE~A~076912~001~AB~Feb 18, 2005~No~RX~TARO PHARMACEUTICALS USA INC
G BASE~A~076912~002~AB~Oct 6, 2004~No~RX~TARO PHARMACEUTICALS USA INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~TEVA~EQ 250M
G BASE~A~076136~001~~Jun 9, 2004~No~DISCN~TEVA PHARMACEUTICALS USA INC
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~UNIQUE PHARM
LABS~EQ 250MG BASE~A~076639~001~AB~Sep 10, 2004~No~RX~UNIQUE PHARMACEUTICAL LAB
ORATORIES
ORATORIES
ORATORIES
CIPROFLOXACIN HYDROCHLORIDE~TABLET;ORAL~CIPROFLOXACIN HYDROCHLORIDE~WATSON LABS~
EQ 100MG BASE~A~076794~001~AB~Feb 10, 2005~No~RX~WATSON LABORATORIES INC
EQ 250MG BASE~A~076794~002~AB~Jun 9, 2004~No~RX~WATSON LABORATORIES INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~ACTAVIS ELIZABETH~EQ

10MG BASE~A~077033~001~~Oct 28, 2004~No~DISCN~ACTAVIS ELIZABETH LLC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~AMNEAL PHARMS NY~EQ
10MG BASE~A~077289~001~AB~Nov 30, 2006~No~RX~AMNEAL PHARMACEUTICALS NY LLC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~APOTEX INC~EQ 10MG B
ASE~A~077046~001~AB~Nov 24, 2004~No~RX~APOTEX INC ETOBICOKE SITE
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~AUROBINDO~EQ 10MG BA
SE~A~077031~001~AB~Oct 28, 2004~No~RX~AUROBINDO PHARMA LTD
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~CIPLA LTD~EQ 10MG BA
SE~A~077044~001~AB~Nov 5, 2004~No~RX~CIPLA LTD
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~COREPHARMA~EQ 10MG B
ASE~A~077036~001~~Oct 28, 2004~No~DISCN~COREPHARMA LLC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~DR REDDYS LABS LTD~E
Q 10MG BASE~A~077038~001~AB~Oct 28, 2004~No~RX~DR REDDYS LABORATORIES LTD
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~EPIC PHARMA~EQ 10MG
BASE~A~077045~003~AB~Apr 29, 2005~No~RX~EPIC PHARMA LLC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~GLENMARK GENERICS~EQ
10MG BASE~A~077654~001~AB~Feb 27, 2009~No~RX~GLENMARK GENERICS LTD
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~INVAGEN PHARMS~EQ 10
MG BASE~A~077534~001~AB~Oct 3, 2006~No~RX~INVAGEN PHARMACEUTICALS INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~MUTUAL PHARM~EQ 10MG

BASE~A~077052~001~~Jul 3, 2006~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~MYLAN~EQ 10MG BASE~A
~077039~001~AB~Feb 3, 2005~No~RX~MYLAN PHARMACEUTICALS INC
~077042~001~AB~Nov 5, 2004~No~RX~MYLAN PHARMACEUTICALS INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~MYLAN PHARMS INC~EQ
10MG BASE~A~077037~001~AB~Nov 5, 2004~No~RX~MYLAN PHARMACEUTICALS INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~NATCO PHARMA LTD~EQ
20MG BASE~A~077141~002~~Apr 10, 2008~No~DISCN~NATCO PHARMA LTD
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~NATCO PHARMA LTD~EQ
40MG BASE~A~077141~001~~Apr 10, 2008~No~DISCN~NATCO PHARMA LTD
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~PLIVA~EQ 10MG BASE~A
~077232~001~AB~Oct 31, 2005~No~RX~PLIVA INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~ROXANE~EQ 10MG BASE~
A~077041~001~~Nov 23, 2004~No~DISCN~ROXANE LABORATORIES INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~SANDOZ~EQ 10MG BASE~
A~077035~001~~Oct 28, 2004~No~DISCN~SANDOZ
A~077040~001~~Aug 17, 2005~No~DISCN~SANDOZ INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~SUN PHARM INDS INC~E
Q 10MG BASE~A~077032~001~AB~Nov 12, 2004~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~TARO~EQ 10MG BASE~A~
077278~001~~Mar 22, 2006~No~DISCN~TARO PHARMACEUTICALS USA INC

CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~TEVA PHARMS~EQ 10MG
BASE~A~077048~001~AB~Nov 16, 2004~No~RX~TEVA PHARMACEUTICALS USA
BASE~A~077213~001~~Mar 31, 2006~No~DISCN~TEVA PHARMACEUTICALS USA
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~TORRENT PHARMS~EQ 10
MG BASE~A~078216~001~AB~Mar 27, 2007~No~RX~TORRENT PHARMACEUTICALS LTD
CITALOPRAM HYDROBROMIDE~TABLET;ORAL~CITALOPRAM HYDROBROMIDE~WATSON LABS~EQ 10MG
BASE~A~077034~001~~Jun 30, 2005~No~DISCN~WATSON LABORATORIES INC
DESLORATADINE~TABLET;ORAL~CLARINEX~MERCK SHARP DOHME~5MG~N~021165~001~AB~Dec 21,
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~ALLIED PHARMA INC~250MG~A~202710~001~A
B~Jun 10, 2013~No~RX~ALLIED PHARMA INC
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~ALLIED PHARMA INC~500MG~A~202710~002~A
B~Jun 10, 2013~No~RX~ALLIED PHARMA INC
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~APOTEX CORP~250MG~A~065384~001~AB~Aug
20, 2007~No~RX~APOTEX CORP
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~APOTEX CORP~500MG~A~065384~002~AB~Aug
20, 2007~No~RX~APOTEX CORP
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~AUROBINDO~250MG~A~065489~001~AB~Jul 25
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~AUROBINDO~500MG~A~065489~002~AB~Jul 25
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~IVAX SUB TEVA PHARMS~250MG~A~065137~00
1~~May 31, 2005~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~IVAX SUB TEVA PHARMS~500MG~A~065137~00
2~~May 31, 2005~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~MYLAN~250MG~A~065195~001~AB~Mar 11, 20
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~MYLAN~500MG~A~065195~002~AB~Mar 11, 20
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~RANBAXY~250MG~A~065174~001~AB~Sep 24,
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~RANBAXY~500MG~A~065174~002~AB~Sep 24,
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~ROXANE~250MG~A~065178~002~AB~May 25, 2
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~ROXANE~500MG~A~065178~001~AB~May 25, 2
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~SANDOZ~250MG~A~065144~001~AB~Oct 18, 2
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~SANDOZ~500MG~A~065136~001~AB~Aug 25, 2
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~TEVA~250MG~A~065155~001~AB~May 31, 200
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~TEVA~500MG~A~065155~002~AB~May 31, 200
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~WOCKHARDT~250MG~A~065266~001~AB~May 31
CLARITHROMYCIN~TABLET;ORAL~CLARITHROMYCIN~WOCKHARDT~500MG~A~065266~002~AB~May 31
LORATADINE~TABLET;ORAL~CLARITIN~BAYER HEALTHCARE LLC~10MG~N~019658~002~~Nov 27,
2002~Yes~OTC~BAYER HEALTHCARE LLC
LORATADINE~TABLET;ORAL~CLARITIN HIVES RELIEF~BAYER HEALTHCARE LLC~10MG~N~019658~
003~~Nov 19, 2003~Yes~OTC~BAYER HEALTHCARE LLC
CLEMASTINE FUMARATE~TABLET;ORAL~CLEMASTINE FUMARATE~PERRIGO~1.34MG~A~074512~001~
~Nov 22, 1995~No~OTC~PERRIGO CO
CLEMASTINE FUMARATE~TABLET;ORAL~CLEMASTINE FUMARATE~SANDOZ~1.34MG~A~073458~001~~
Oct 31, 1993~No~OTC~SANDOZ INC
CLEMASTINE FUMARATE~TABLET;ORAL~CLEMASTINE FUMARATE~SANDOZ~2.68MG~A~073459~001~A
B~Oct 31, 1993~No~RX~SANDOZ INC
CLEMASTINE FUMARATE~TABLET;ORAL~CLEMASTINE FUMARATE~TEVA~1.34MG~A~073282~001~~Ja
CLEMASTINE FUMARATE~TABLET;ORAL~CLEMASTINE FUMARATE~TEVA~1.34MG~A~073282~002~~De
c 3, 1992~No~DISCN~TEVA PHARMACEUTICALS USA INC
CLEMASTINE FUMARATE~TABLET;ORAL~CLEMASTINE FUMARATE~TEVA~2.68MG~A~073283~001~AB~
Jan 31, 1992~Yes~RX~TEVA PHARMACEUTICALS USA INC
SULINDAC~TABLET;ORAL~CLINORIL~MERCK~150MG~N~017911~001~~Approved Prior to Jan 1,
1982~No~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
SULINDAC~TABLET;ORAL~CLINORIL~MERCK~200MG~N~017911~002~AB~Approved Prior to Jan
1, 1982~Yes~RX~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
CARBINOXAMINE MALEATE~TABLET;ORAL~CLISTIN~ORTHO MCNEIL PHARM~4MG~N~008915~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
CLOMIPHENE CITRATE~TABLET;ORAL~CLOMID~SANOFI AVENTIS US~50MG~N~016131~002~AB~App
roved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
CLOMIPHENE CITRATE~TABLET;ORAL~CLOMIPHENE CITRATE~PAR PHARM~50MG~A~075528~001~AB
~Aug 30, 1999~No~RX~PAR PHARMACEUTICAL INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~ACCORD HLTHCARE~0.5MG~A~077147~001~AB~May 2, 2
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~ACCORD HLTHCARE~1MG~A~077147~002~AB~May 2, 200
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~ACCORD HLTHCARE~2MG~A~077147~003~AB~May 2, 200
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~ACTAVIS ELIZABETH~0.5MG~A~074869~001~AB~Oct 31
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~ACTAVIS ELIZABETH~1MG~A~074869~002~AB~Oct 31,
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~ACTAVIS ELIZABETH~2MG~A~074869~003~AB~Oct 31,
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~APOTEX INC~0.5MG~A~075468~001~~Oct 6, 2000~No~
DISCN~APOTEX INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~APOTEX INC~1MG~A~075468~002~~Oct 6, 2000~No~DI
SCN~APOTEX INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~APOTEX INC~2MG~A~075468~003~~Oct 6, 2000~No~DI
SCN~APOTEX INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~MYLAN~0.5MG~A~075150~001~AB~Oct 5, 1998~No~RX~
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~MYLAN~1MG~A~075150~002~AB~Oct 5, 1998~No~RX~MY
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~MYLAN~2MG~A~075150~003~AB~Oct 5, 1998~No~RX~MY
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~MYLAN PHARMS INC~0.5MG~A~074940~001~AB~Oct 30,

CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~MYLAN PHARMS INC~1MG~A~074940~002~AB~Oct 30, 1
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~MYLAN PHARMS INC~2MG~A~074940~003~AB~Oct 30, 1
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SANDOZ~0.5MG~A~074925~001~~Sep 30, 1997~No~DIS
CN~SANDOZ INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SANDOZ~0.5MG~A~074979~001~AB~Aug 29, 1997~No~R
X~SANDOZ INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SANDOZ~1MG~A~074925~002~~Sep 30, 1997~No~DISCN
~SANDOZ INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SANDOZ~1MG~A~074979~002~AB~Aug 29, 1997~No~RX~
SANDOZ INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SANDOZ~2MG~A~074925~003~~Sep 30, 1997~No~DISCN
~SANDOZ INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SANDOZ~2MG~A~074979~003~AB~Aug 29, 1997~No~RX~
SANDOZ INC
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SUN PHARM INDS INC~0.5MG~A~075423~001~AB~Apr 2
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SUN PHARM INDS INC~1MG~A~075423~002~AB~Apr 27,
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~SUN PHARM INDS INC~2MG~A~075423~003~AB~Apr 27,
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~TEVA~0.5MG~A~074569~001~AB~Sep 10, 1996~No~RX~
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~TEVA~0.5MG~A~074920~001~~Aug 4, 1998~No~DISCN~
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~TEVA~1MG~A~074569~002~AB~Sep 10, 1996~No~RX~TE
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~TEVA~1MG~A~074920~002~~Aug 4, 1998~No~DISCN~TE
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~TEVA~2MG~A~074569~003~AB~Sep 10, 1996~No~RX~TE
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~TEVA~2MG~A~074920~003~~Aug 4, 1998~No~DISCN~TE
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~VINTAGE PHARMS~0.5MG~A~077856~001~AB~Jun 28, 2
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~VINTAGE PHARMS~1MG~A~077856~002~AB~Jun 28, 200
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~VINTAGE PHARMS~2MG~A~077856~003~AB~Jun 28, 200
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~WATSON LABS~0.5MG~A~074964~001~AB~Dec 30, 1997
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~WATSON LABS~1MG~A~074964~002~AB~Dec 30, 1997~N
CLONAZEPAM~TABLET;ORAL~CLONAZEPAM~WATSON LABS~2MG~A~074964~003~AB~Dec 30, 1997~N
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~ACTAVIS ELIZABETH~0.
1MG~A~070974~001~AB~Dec 16, 1986~No~RX~ACTAVIS ELIZABETH LLC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~ALEMBIC PHARMS LTD~0
.1MG~A~091368~001~AB~Dec 6, 2011~No~RX~ALEMBIC PHARMACEUTICALS LTD
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~AM THERAP~0.1MG~A~07

0881~001~~Jul 8, 1986~No~DISCN~AMERICAN THERAPEUTICS INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~CARLSBAD~0.1MG~A~202
297~001~AB~Jun 13, 2013~No~RX~CARLSBAD TECHNOLOGY INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~DAVA PHARMS INC~0.1M
G~A~071783~001~AB~Apr 5, 1988~No~RX~DAVA PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~DURAMED PHARMS BARR~
0.1MG~A~071103~001~~Aug 14, 1986~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR L
ABORATORIES INC
ABORATORIES INC
ABORATORIES INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~IMPAX LABS~0.1MG~A~0
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~INTERPHARM~0.1MG~A~0
71252~001~~Oct 1, 1986~No~DISCN~INTERPHARM INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~MUTUAL PHARM~0.1MG~A
~070925~001~AB~Sep 4, 1987~No~RX~MUTUAL PHARMACEUTICAL CO INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~MYLAN~0.1MG~A~070317
~003~AB~Jun 9, 1987~No~RX~MYLAN PHARMACEUTICALS INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~PAR PHARM~0.1MG~A~07
0461~001~~Jul 8, 1986~No~DISCN~PAR PHARMACEUTICAL INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~SANDOZ~0.1MG~A~07088

CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~SUN PHARM INDS INC~0
.1MG~A~090329~001~AB~Jul 3, 2014~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~TEVA~0.1MG~A~070747~
001~~Jul 8, 1986~No~DISCN~TEVA PHARMACEUTICALS USA INC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~UNICHEM~0.1MG~A~0788
95~001~AB~Aug 26, 2009~No~RX~UNICHEM LABORATORIES LTD
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~VINTAGE~0.1MG~A~0779
01~001~AB~Mar 9, 2007~No~RX~VINTAGE PHARMACEUTICALS LLC
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~WARNER CHILCOTT~0.1M
G~A~072138~001~~Jun 13, 1988~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE~WATSON LABS~0.1MG~A~
CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLONIDINE HYDROCHLORIDE AND
CHLORTHALIDONE~PAR PHARM~15MG;0.1MG~A~071179~001~~Dec 16, 1987~No~DISCN~PAR PHAR
MACEUTICAL INC
MACEUTICAL INC
MACEUTICAL INC
CLOPIDOGREL~TABLET;ORAL~CLOPIDOGREL~AMNEAL PHARMS~75MG~A~203751~001~AB~Apr 11, 2
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~ACCORD HLTHCARE~EQ 75MG
BASE~A~202925~001~AB~Mar 27, 2013~No~RX~ACCORD HEALTHCARE INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~ACCORD HLTHCARE~EQ 300MG
BASE~A~202925~002~AB~Mar 27, 2013~No~RX~ACCORD HEALTHCARE INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~ACTAVIS TOTOWA~EQ 75MG B

ASE~A~090307~001~AB~May 28, 2013~No~RX~ACTAVIS TOTOWA LLC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~APOTEX INC~EQ 75MG BASE~
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~APOTEX INC~EQ 300MG BASE
~A~076274~002~AB~Mar 4, 2014~No~RX~APOTEX INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~AUROBINDO PHARMA LTD~EQ
75MG BASE~A~090540~001~AB~May 17, 2012~No~RX~AUROBINDO PHARMA LTD
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~DR REDDYS LABS INC~EQ 75
MG BASE~A~076273~001~AB~Jan 14, 2008~No~RX~DR REDDYS LABORATORIES INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~DR REDDYS LABS LTD~EQ 30
0MG BASE~A~091023~001~AB~May 17, 2012~No~RX~DR REDDYS LABORATORIES LTD
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~GATE PHARMS~EQ 300MG BAS
E~A~091216~001~AB~May 17, 2012~No~RX~GATE PHARMACEUTICALS
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~MACLEODS PHARMS LTD~EQ 7
5MG BASE~A~202928~001~AB~Feb 10, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~MUTUAL PHARM~EQ 75MG BAS
E~A~078133~001~AB~Jun 10, 2013~No~RX~MUTUAL PHARMACEUTICAL CO INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~MYLAN PHARMS INC~EQ 75MG
BASE~A~077665~001~AB~May 17, 2012~No~RX~MYLAN PHARMACEUTICALS INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~MYLAN PHARMS INC~EQ 300M
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~ROXANE~EQ 75MG BASE~A~07
8004~001~AB~May 17, 2012~No~RX~ROXANE LABORATORIES INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~SCIEGEN PHARMS INC~EQ 75
MG BASE~A~204165~001~AB~Sep 15, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~SCIEGEN PHARMS INC~EQ 30
0MG BASE~A~204165~002~AB~Sep 15, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~SUN PHARMA GLOBAL~EQ 75M
G BASE~A~090494~001~AB~May 17, 2012~No~RX~SUN PHARMA GLOBAL FZE
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~TEVA~EQ 75MG BASE~A~0769
99~001~AB~May 17, 2012~No~RX~TEVA PHARMACEUTICALS USA INC
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~TEVA PHARMS~EQ 300MG BAS
E~A~090625~001~AB~May 17, 2012~No~RX~TEVA PHARMACEUTICALS USA
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~TORRENT PHARMS LTD~EQ 75
MG BASE~A~090844~001~AB~May 17, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~WOCKHARDT LTD~EQ 75MG BA
SE~A~202266~001~AB~Aug 14, 2012~No~RX~WOCKHARDT LTD
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~WOCKHARDT LTD~EQ 300MG B
ASE~A~202266~002~AB~Nov 20, 2012~No~RX~WOCKHARDT LTD
CLOPIDOGREL BISULFATE~TABLET;ORAL~CLOPIDOGREL BISULFATE~ZYDUS PHARMS USA INC~EQ
75MG BASE~A~201686~001~AB~Oct 10, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~CLOPRA~QUANTUM PHARMICS~EQ 5MG BASE~A~0
72384~001~~Jun 2, 1988~No~DISCN~QUANTUM PHARMICS LTD
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~CLOPRA~QUANTUM PHARMICS~EQ 10MG BASE~A~
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~"CLOPRA-""YELLOW"""~QUANTUM PHARMICS~EQ
10MG BASE~A~070632~001~~Oct 28, 1985~No~DISCN~QUANTUM PHARMICS LTD
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~ABLE~3.75MG~A~071780
~001~~Jun 26, 1987~No~DISCN~ABLE LABORATORIES INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~ABLE~7.5MG~A~071781~
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~ABLE~15MG~A~071782~0
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~AM THERAP~3.75MG~A~0
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~AM THERAP~7.5MG~A~07
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~AM THERAP~15MG~A~071
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~LEDERLE~3.75MG~A~072

013~001~~Dec 15, 1987~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~LEDERLE~7.5MG~A~0720
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~LEDERLE~15MG~A~07201
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~MYLAN~3.75MG~A~07185
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~MYLAN~7.5MG~A~071858
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~MYLAN~15MG~A~071858~
001~AB~Jul 17, 1987~No~RX~MYLAN PHARMACEUTICALS INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~PUREPAC PHARM~3.75MG
~A~072330~001~~Aug 8, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~PUREPAC PHARM~7.5MG~
A~072331~001~~Aug 8, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~PUREPAC PHARM~15MG~A
~072332~001~~Aug 8, 1988~No~DISCN~PUREPAC PHARMACEUTICAL CO
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~QUANTUM PHARMICS~3.7
5MG~A~071730~001~~Oct 26, 1987~No~DISCN~QUANTUM PHARMICS LTD
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~QUANTUM PHARMICS~7.5
MG~A~071731~001~~Oct 26, 1987~No~DISCN~QUANTUM PHARMICS LTD
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~QUANTUM PHARMICS~15M
G~A~071702~001~~Oct 26, 1987~No~DISCN~QUANTUM PHARMICS LTD
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~RANBAXY~3.75MG~A~076
911~001~AB~Sep 29, 2004~No~RX~RANBAXY LABORATORIES LTD
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~RANBAXY~7.5MG~A~0769
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~RANBAXY~15MG~A~07691
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~SANDOZ~3.75MG~A~0725
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~SANDOZ~7.5MG~A~07251
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~SANDOZ~15MG~A~072514
~001~~May 11, 1990~No~DISCN~SANDOZ INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~TARO~3.75MG~A~075731
~003~AB~Apr 27, 2000~No~RX~TARO PHARMACEUTICALS USA INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~TARO~7.5MG~A~075731~
002~AB~Apr 27, 2000~No~RX~TARO PHARMACEUTICALS USA INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~TARO~15MG~A~075731~0
01~AB~Apr 27, 2000~No~RX~TARO PHARMACEUTICALS USA INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~WARNER CHILCOTT~3.75
MG~A~071828~001~~Mar 3, 1988~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~WARNER CHILCOTT~7.5M
G~A~071829~001~~Mar 3, 1988~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~WARNER CHILCOTT~15MG
~A~071830~001~~Mar 3, 1988~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~WATSON LABS~3.75MG~A
~071852~001~~Feb 9, 1988~No~DISCN~WATSON LABORATORIES INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~WATSON LABS~7.5MG~A~
071853~001~~Feb 9, 1988~No~DISCN~WATSON LABORATORIES INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~CLORAZEPATE DIPOTASSIUM~WATSON LABS~15MG~A~0
71854~001~~Feb 9, 1988~No~DISCN~WATSON LABORATORIES INC
CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE~TABLET;ORAL~CLORPRES~MYLAN~15MG;0.1MG~A~
071325~003~~Feb 9, 1987~No~RX~MYLAN PHARMACEUTICALS INC
071325~002~~Feb 9, 1987~No~RX~MYLAN PHARMACEUTICALS INC
071325~001~~Feb 9, 1987~Yes~RX~MYLAN PHARMACEUTICALS INC
CLOZAPINE~TABLET;ORAL~CLOZAPINE~IVAX SUB TEVA PHARMS~12.5MG~A~074949~003~AB~Jul

CLOZAPINE~TABLET;ORAL~CLOZAPINE~IVAX SUB TEVA PHARMS~25MG~A~074949~001~AB~Nov 26
CLOZAPINE~TABLET;ORAL~CLOZAPINE~IVAX SUB TEVA PHARMS~50MG~A~074949~004~AB~Apr 25
CLOZAPINE~TABLET;ORAL~CLOZAPINE~IVAX SUB TEVA PHARMS~50MG~A~076809~003~AB~Dec 16
CLOZAPINE~TABLET;ORAL~CLOZAPINE~IVAX SUB TEVA PHARMS~100MG~A~074949~002~AB~Nov 2
CLOZAPINE~TABLET;ORAL~CLOZAPINE~MYLAN~12.5MG~A~075417~003~AB~Apr 15, 2010~No~RX~
CLOZAPINE~TABLET;ORAL~CLOZAPINE~MYLAN~25MG~A~075417~001~AB~May 27, 1999~No~RX~MY
CLOZAPINE~TABLET;ORAL~CLOZAPINE~MYLAN~50MG~A~075417~004~AB~Apr 15, 2010~No~RX~MY
CLOZAPINE~TABLET;ORAL~CLOZAPINE~MYLAN~100MG~A~075417~002~AB~May 27, 1999~No~RX~M
CLOZAPINE~TABLET;ORAL~CLOZAPINE~MYLAN~200MG~A~075417~005~AB~Apr 15, 2010~No~RX~M
CLOZAPINE~TABLET;ORAL~CLOZAPINE~PAR PHARM~25MG~A~075162~001~~Apr 26, 2005~No~DIS
CN~PAR PHARMACEUTICAL
CLOZAPINE~TABLET;ORAL~CLOZAPINE~PAR PHARM~100MG~A~075162~002~~Apr 26, 2005~No~DI
SCN~PAR PHARMACEUTICAL
CLOZAPINE~TABLET;ORAL~CLOZAPINE~SANDOZ~25MG~A~074546~001~~Aug 30, 1996~No~DISCN~
SANDOZ INC
CLOZAPINE~TABLET;ORAL~CLOZAPINE~SANDOZ~100MG~A~074546~002~~Aug 30, 1996~No~DISCN
~SANDOZ INC
CLOZAPINE~TABLET;ORAL~CLOZAPINE~SUN PHARM INDS INC~25MG~A~075713~001~AB~Nov 15,
CLOZAPINE~TABLET;ORAL~CLOZAPINE~SUN PHARM INDS INC~50MG~A~075713~003~AB~Aug 19,
CLOZAPINE~TABLET;ORAL~CLOZAPINE~SUN PHARM INDS INC~100MG~A~075713~002~AB~Nov 15,
CLOZAPINE~TABLET;ORAL~CLOZARIL~NOVARTIS~25MG~N~019758~001~AB~Sep 26, 1989~No~RX~
CLOZAPINE~TABLET;ORAL~CLOZARIL~NOVARTIS~100MG~N~019758~002~AB~Sep 26, 1989~Yes~R
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~CO-GESIC~UCB INC~500MG;5MG~A~0
87757~001~~May 3, 1982~No~DISCN~UCB INC
ARTEMETHER; LUMEFANTRINE~TABLET;ORAL~COARTEM~NOVARTIS~20MG;120MG~N~022268~001~~A
pr 7, 2009~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
CODEINE SULFATE~TABLET;ORAL~CODEINE SULFATE~LANNETT HOLDINGS INC~15MG~A~203046~0
01~AB~Jun 13, 2014~No~RX~LANNETT HOLDINGS INC
CODEINE SULFATE~TABLET;ORAL~CODEINE SULFATE~ROXANE~15MG~N~022402~001~AB~Jul 16,
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE~TABLET;ORAL~CODOXY~HAL
SEY~325MG;4.5MG;0.38MG~A~087464~001~~Jul 1, 1982~No~DISCN~HALSEY DRUG CO INC
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~CODRIX~WATSON LABS FLORIDA~500MG;15

MG~A~040447~001~~Feb 26, 2003~No~DISCN~WATSON LABORATORIES INC FLORIDA
MG~A~040441~001~~Mar 27, 2003~No~DISCN~WATSON LABORATORIES INC FLORIDA
MG~A~040488~001~~Mar 28, 2003~No~DISCN~WATSON LABORATORIES INC FLORIDA
BENZTROPINE MESYLATE~TABLET;ORAL~COGENTIN~MERCK~0.5MG~N~009193~004~~Approved Pri
or to Jan 1, 1982~No~DISCN~MERCK AND CO INC
BENZTROPINE MESYLATE~TABLET;ORAL~COGENTIN~MERCK~1MG~N~009193~003~~Approved Prior
BENZTROPINE MESYLATE~TABLET;ORAL~COGENTIN~MERCK~2MG~N~009193~002~~Approved Prior
COLCHICINE; PROBENECID~TABLET;ORAL~COL-PROBENECID~WATSON LABS~0.5MG;500MG~A~0842
79~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
COLCHICINE; PROBENECID~TABLET;ORAL~COLBENEMID~MERCK~0.5MG;500MG~N~012383~001~~Ap
COLCHICINE~TABLET;ORAL~COLCRYS~TAKEDA PHARMS USA~0.6MG~N~022352~001~~Jul 29, 200
9~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
COLESTIPOL HYDROCHLORIDE~TABLET;ORAL~COLESTID~PHARMACIA AND UPJOHN~1GM~N~020222~
001~AB~Jul 19, 1994~Yes~RX~PHARMACIA AND UPJOHN CO
COLESTIPOL HYDROCHLORIDE~TABLET;ORAL~COLESTIPOL HYDROCHLORIDE~IMPAX LABS~1GM~A~0
77510~001~AB~Oct 24, 2006~No~RX~IMPAX LABORATORIES INC
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~TABLET;ORAL~COLONAID~MEDPOINTE PHA
RM HLC~0.025MG;2.5MG~A~085737~001~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOI
NTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE~TABLET;ORAL~COMBIPRES~BOEHRINGER INGELHE
IM~15MG;0.1MG~N~017503~001~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER IN
GELHEIM PHARMACEUTICALS INC
IM~15MG;0.2MG~N~017503~002~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER IN
GELHEIM PHARMACEUTICALS INC
IM~15MG;0.3MG~N~017503~003~~Apr 10, 1984~No~DISCN~BOEHRINGER INGELHEIM PHARMACEU
TICALS INC
LAMIVUDINE; ZIDOVUDINE~TABLET;ORAL~COMBIVIR~VIIV HLTHCARE~150MG;300MG~N~020857~0
01~AB~Sep 26, 1997~Yes~RX~VIIV HEALTHCARE CO
IBUPROFEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~COMBUNOX~FOREST LABS~400MG;5MG~N~
021378~001~~Nov 26, 2004~No~DISCN~FOREST LABORATORIES INC
PROCHLORPERAZINE MALEATE~TABLET;ORAL~COMPAZINE~GLAXOSMITHKLINE~EQ 5MG BASE~N~010
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE~TABLET;O
RAL~COMPLERA~GILEAD SCIENCES INC~200MG;EQ 25MG BASE;300MG~N~202123~001~~Aug 10,
ENTACAPONE~TABLET;ORAL~COMTAN~ORION PHARMA~200MG~N~020796~001~AB~Oct 19, 1999~Ye
s~RX~ORION PHARMA
RIBAVIRIN~TABLET;ORAL~COPEGUS~ROCHE~200MG~N~021511~001~AB~Dec 3, 2002~No~RX~HOFF
MANN LA ROCHE INC
RIBAVIRIN~TABLET;ORAL~COPEGUS~ROCHE~400MG~N~021511~002~~Jun 21, 2005~No~DISCN~HO
FFMANN LA ROCHE INC
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~CORDARONE~WYETH PHARMS INC~200MG~N~018972~0
01~AB~Dec 24, 1985~Yes~RX~WYETH PHARMACEUTICALS INC
CARVEDILOL~TABLET;ORAL~COREG~SMITHKLINE BEECHAM~3.125MG~N~020297~004~AB~May 29,
1997~No~RX~SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
CARVEDILOL~TABLET;ORAL~COREG~SMITHKLINE BEECHAM~6.25MG~N~020297~003~AB~Sep 14, 1
CARVEDILOL~TABLET;ORAL~COREG~SMITHKLINE BEECHAM~12.5MG~N~020297~002~AB~Sep 14, 1
995~Yes~RX~SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE

CARVEDILOL~TABLET;ORAL~COREG~SMITHKLINE BEECHAM~25MG~N~020297~001~AB~Sep 14, 199
NADOLOL~TABLET;ORAL~CORGARD~KING PHARMS~20MG~N~018063~005~AB~Oct 28, 1986~No~RX~
KING PHARMACEUTICALS INC
NADOLOL~TABLET;ORAL~CORGARD~KING PHARMS~40MG~N~018063~001~AB~Approved Prior to J
an 1, 1982~No~RX~KING PHARMACEUTICALS INC
NADOLOL~TABLET;ORAL~CORGARD~KING PHARMS~80MG~N~018063~002~AB~Approved Prior to J
NADOLOL~TABLET;ORAL~CORGARD~KING PHARMS~120MG~N~018063~003~~Approved Prior to Ja
n 1, 1982~No~DISCN~KING PHARMACEUTICALS INC
NADOLOL~TABLET;ORAL~CORGARD~KING PHARMS~160MG~N~018063~004~~Approved Prior to Ja
n 1, 1982~No~DISCN~KING PHARMACEUTICALS INC
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~CORPHED~SA
NDOZ~60MG;2.5MG~A~088602~001~~Apr 11, 1985~No~DISCN~SANDOZ INC
PREDNISOLONE~TABLET;ORAL~CORTALONE~HALSEY~1MG~A~080304~003~~Approved Prior to Ja
n 1, 1982~No~DISCN~HALSEY DRUG CO INC
PREDNISOLONE~TABLET;ORAL~CORTALONE~HALSEY~2.5MG~A~080304~002~~Approved Prior to
Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
PREDNISOLONE~TABLET;ORAL~CORTALONE~HALSEY~5MG~A~080304~001~~Approved Prior to Ja
PREDNISONE~TABLET;ORAL~CORTAN~HALSEY~20MG~A~087480~001~~Approved Prior to Jan 1,
HYDROCORTISONE~TABLET;ORAL~CORTEF~PHARMACIA AND UPJOHN~5MG~N~008697~003~AB~Appro
ved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
HYDROCORTISONE~TABLET;ORAL~CORTEF~PHARMACIA AND UPJOHN~10MG~N~008697~001~AB~Appr
oved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
HYDROCORTISONE~TABLET;ORAL~CORTEF~PHARMACIA AND UPJOHN~20MG~N~008697~002~AB~Appr
oved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~BARR~25MG~A~083471~001~~Approved
Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~ELKINS SINN~25MG~A~080836~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~EVERYLIFE~25MG~A~084246~001~~App
roved Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~HEATHER~25MG~A~085736~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~HIKMA INTL PHARMS~25MG~A~080776~
002~~Approved Prior to Jan 1, 1982~Yes~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LL
C
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~IMPAX LABS~25MG~N~009458~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~INWOOD LABS~25MG~A~080731~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORAT
ORIES INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~IVAX SUB TEVA PHARMS~25MG~A~0806
30~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA
PHARMACEUTICALS USA
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~IVAX SUB TEVA PHARMS~25MG~A~0835
36~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA
PHARMACEUTICALS USA
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~LANNETT~25MG~A~080694~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~PANRAY~5MG~N~008284~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~PANRAY~25MG~N~008284~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~PHARMACIA AND UPJOHN~5MG~N~00812

CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~PUREPAC PHARM~25MG~A~080493~001~
~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~VITARINE~25MG~A~080333~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~WATSON LABS~25MG~A~085884~001~~A
CORTISONE ACETATE~TABLET;ORAL~CORTISONE ACETATE~WHITEWORTH TOWN PLSN~25MG~A~0803
CORTISONE ACETATE~TABLET;ORAL~CORTONE~MERCK~25MG~N~007750~003~~Approved Prior to
Jan 1, 1982~No~DISCN~MERCK AND CO INC
HYDROCORTISONE~TABLET;ORAL~CORTRIL~PFIZER~10MG~N~009127~005~~Approved Prior to J
HYDROCORTISONE~TABLET;ORAL~CORTRIL~PFIZER~20MG~N~009127~003~~Approved Prior to J
BENDROFLUMETHIAZIDE; NADOLOL~TABLET;ORAL~CORZIDE~KING PHARMS~5MG;40MG~N~018647~0
01~AB~May 25, 1983~No~RX~KING PHARMACEUTICALS INC
BENDROFLUMETHIAZIDE; NADOLOL~TABLET;ORAL~CORZIDE~KING PHARMS~5MG;80MG~N~018647~0
02~AB~May 25, 1983~Yes~RX~KING PHARMACEUTICALS INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~COTRIM~TEVA~400MG;80MG~A~070034~001~~
May 16, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~COTRIM D.S.~TEVA~800MG;160MG~A~070048
~001~~Mar 18, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~1MG~N~009218~022~AB~Ma
r 1, 1990~No~RX~BRISTOL MYERS SQUIBB PHARMA CO
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~2MG~N~009218~013~AB~Ap
proved Prior to Jan 1, 1982~No~RX~BRISTOL MYERS SQUIBB PHARMA CO
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~2.5MG~N~009218~018~AB~
Approved Prior to Jan 1, 1982~No~RX~BRISTOL MYERS SQUIBB PHARMA CO
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~3MG~N~009218~025~AB~No
v 18, 1996~No~RX~BRISTOL MYERS SQUIBB PHARMA CO
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~4MG~N~009218~023~AB~Au
g 24, 1993~No~RX~BRISTOL MYERS SQUIBB PHARMA CO
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~5MG~N~009218~007~AB~Ap
proved Prior to Jan 1, 1982~No~RX~BRISTOL MYERS SQUIBB PHARMA CO
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~6MG~N~009218~026~AB~No
v 18, 1996~No~RX~BRISTOL MYERS SQUIBB PHARMA CO
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~7.5MG~N~009218~016~AB~
Approved Prior to Jan 1, 1982~No~RX~BRISTOL MYERS SQUIBB PHARMA CO
WARFARIN SODIUM~TABLET;ORAL~COUMADIN~BRISTOL MYERS SQUIBB~10MG~N~009218~005~AB~A
pproved Prior to Jan 1, 1982~Yes~RX~BRISTOL MYERS SQUIBB PHARMA CO
LOSARTAN POTASSIUM~TABLET;ORAL~COZAAR~MERCK SHARP DOHME~25MG~N~020386~001~AB~Apr
14, 1995~No~RX~MERCK SHARP AND DOHME CORP
LOSARTAN POTASSIUM~TABLET;ORAL~COZAAR~MERCK SHARP DOHME~50MG~N~020386~002~AB~Apr
14, 1995~No~RX~MERCK SHARP AND DOHME CORP
LOSARTAN POTASSIUM~TABLET;ORAL~COZAAR~MERCK SHARP DOHME~100MG~N~020386~003~AB~Oc
t 13, 1998~Yes~RX~MERCK SHARP AND DOHME CORP
ROSUVASTATIN CALCIUM~TABLET;ORAL~CRESTOR~IPR~5MG~N~021366~002~~Aug 12, 2003~No~R
X~IPR PHARMACEUTICALS INC
ROSUVASTATIN CALCIUM~TABLET;ORAL~CRESTOR~IPR~10MG~N~021366~003~~Aug 12, 2003~No~
RX~IPR PHARMACEUTICALS INC
ROSUVASTATIN CALCIUM~TABLET;ORAL~CRESTOR~IPR~20MG~N~021366~004~~Aug 12, 2003~No~
RX~IPR PHARMACEUTICALS INC
ROSUVASTATIN CALCIUM~TABLET;ORAL~CRESTOR~IPR~40MG~N~021366~005~~Aug 12, 2003~Yes
~RX~IPR PHARMACEUTICALS INC
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~CURRETAB~SOLVAY~10MG~A~085686~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
CYANOCOBALAMIN~TABLET;ORAL~CYANOCOBALAMIN~WEST WARD~1MG~A~084264~001~~Approved P
rior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP

CYCLACILLIN~TABLET;ORAL~CYCLACILLIN~TEVA~250MG~A~062895~001~~Aug 4, 1988~No~DISC
CYCLACILLIN~TABLET;ORAL~CYCLACILLIN~TEVA~500MG~A~062895~002~~Aug 4, 1988~No~DISC
CYCLACILLIN~TABLET;ORAL~CYCLAPEN-W~WYETH AYERST~250MG~N~050509~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
CYCLACILLIN~TABLET;ORAL~CYCLAPEN-W~WYETH AYERST~500MG~N~050509~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~ACTAVIS
LABS FL INC~5MG~A~071611~002~AB~Feb 3, 2006~No~RX~ACTAVIS LABORATORIES FL INC
LABS FL INC~7.5MG~A~071611~003~AB~Feb 3, 2006~No~RX~ACTAVIS LABORATORIES FL INC
LABS FL INC~10MG~A~071611~001~AB~May 3, 1989~No~RX~ACTAVIS LABORATORIES FL INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~AUROBIND
O PHARMA~5MG~A~078643~001~AB~Sep 26, 2008~No~RX~AUROBINDO PHARMA LTD
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~AUROBIND
O PHARMA~10MG~A~078643~002~AB~Sep 26, 2008~No~RX~AUROBINDO PHARMA LTD
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~INVAGEN
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~INVAGEN
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~JUBILANT
CADISTA~5MG~A~077563~001~AB~Apr 19, 2006~No~RX~JUBILANT CADISTA PHARMACEUTICALS
INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~JUBILANT
CADISTA~10MG~A~077563~002~AB~Apr 19, 2006~No~RX~JUBILANT CADISTA PHARMACEUTICAL
S INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~KVK TECH
~5MG~A~078048~001~AB~Feb 28, 2011~No~RX~KVK TECH INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~KVK TECH
~10MG~A~078048~002~AB~Feb 28, 2011~No~RX~KVK TECH INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~MUTUAL P
HARM~5MG~A~073541~002~AB~Apr 6, 2006~No~RX~MUTUAL PHARMACEUTICAL CO INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~MUTUAL P
HARM~10MG~A~073541~001~AB~May 23, 1995~No~RX~MUTUAL PHARMACEUTICAL CO INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~MYLAN PH
ARMS INC~5MG~A~073144~002~AB~Feb 3, 2006~No~RX~MYLAN PHARMACEUTICALS INC
ARMS INC~7.5MG~A~073144~003~AB~Mar 25, 2013~No~RX~MYLAN PHARMACEUTICALS INC
ARMS INC~10MG~A~073144~001~AB~May 30, 1991~Yes~RX~MYLAN PHARMACEUTICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~ORIT LAB
S LLC~10MG~A~078218~001~AB~Apr 18, 2008~No~RX~ORIT LABORATORIES LLC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~PLIVA~10
MG~A~074421~001~AB~Sep 29, 1995~No~RX~PLIVA INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~PROSAM L
ABS~5MG~A~077291~001~~Feb 3, 2006~No~DISCN~PROSAM LABS LLC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~PROSAM L
ABS~10MG~A~077209~001~AB~Oct 4, 2005~No~RX~PROSAM LABS LLC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~RANBAXY~
5MG~A~078722~001~AB~May 12, 2008~No~RX~RANBAXY LABORATORIES LTD
7.5MG~A~078722~002~AB~May 12, 2008~No~RX~RANBAXY LABORATORIES LTD
10MG~A~078722~003~AB~May 12, 2008~No~RX~RANBAXY LABORATORIES LTD
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~SANDOZ~5
MG~A~072854~002~~Feb 3, 2006~No~DISCN~SANDOZ INC
0MG~A~072854~001~~Nov 19, 1991~No~DISCN~SANDOZ INC

0MG~A~073683~001~~Feb 26, 1993~No~DISCN~SANDOZ INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~VINTAGE
PHARMS~5MG~A~077797~001~AB~Feb 28, 2007~No~RX~VINTAGE PHARMACEUTICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~VINTAGE
PHARMS~10MG~A~077797~002~AB~Feb 28, 2007~No~RX~VINTAGE PHARMACEUTICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~WATSON L
ABS~10MG~A~073143~001~~Nov 27, 1991~No~DISCN~WATSON LABORATORIES INC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~CYCLOBENZAPRINE HYDROCHLORIDE~WATSON L
ABS~10MG~A~074436~001~~Nov 30, 1994~No~DISCN~WATSON LABORATORIES INC
CYCLOPHOSPHAMIDE~TABLET;ORAL~CYCLOPHOSPHAMIDE~ROXANE~25MG~A~040032~001~~Aug 17,
CYCLOPHOSPHAMIDE~TABLET;ORAL~CYCLOPHOSPHAMIDE~ROXANE~50MG~A~040032~002~~Aug 17,
BROMOCRIPTINE MESYLATE~TABLET;ORAL~CYCLOSET~VEROSCIENCE~EQ 0.8MG BASE~N~020866~0
01~~May 5, 2009~Yes~RX~VEROSCIENCE LLC
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~CYCRIN~ESI ~2.5MG~A~081239~001~~Oct 30,
1992~No~DISCN~ESI PHARMACAL
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~CYCRIN~ESI ~5MG~A~081240~001~~Oct 30, 19
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~CYCRIN~ESI ~10MG~A~089386~001~~Sep 9, 19
TRANEXAMIC ACID~TABLET;ORAL~CYKLOKAPRON~PHARMACIA AND UPJOHN~500MG~N~019280~001~
~Dec 30, 1986~No~DISCN~PHARMACIA AND UPJOHN CO
PEMOLINE~TABLET;ORAL~CYLERT~ABBOTT~18.75MG~N~016832~001~~Approved Prior to Jan 1
, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
PEMOLINE~TABLET;ORAL~CYLERT~ABBOTT~37.5MG~N~016832~002~~Approved Prior to Jan 1,
PEMOLINE~TABLET;ORAL~CYLERT~ABBOTT~75MG~N~016832~003~~Approved Prior to Jan 1, 1
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~AM THERAP~
4MG~A~088798~001~~Feb 15, 1985~No~DISCN~AMERICAN THERAPEUTICS INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~ASCOT~4MG~
A~087685~001~~Oct 25, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL
LABORATORIES INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~COREPHARMA
~4MG~A~040537~001~AA~Sep 30, 2003~No~RX~COREPHARMA LLC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~DURAMED PH
ARMS BARR~4MG~A~088232~001~~Oct 25, 1983~No~DISCN~DURAMED PHARMACEUTICALS INC SU
B BARR LABORATORIES INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~HALSEY~4MG
~A~089057~001~~Jul 3, 1986~No~DISCN~HALSEY DRUG CO INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~IVAX SUB T
EVA PHARMS~4MG~A~087056~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~IVAX PHARMAC
EUTICALS INC SUB TEVA PHARMACEUTICALS USA
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~KV PHARM~4
MG~A~086737~001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~MD PHARM~4
MG~A~087566~001~~Nov 10, 1982~No~DISCN~MD PHARMACEUTICAL INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~MYLAN~4MG~
A~086678~001~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~PAR PHARM~
4MG~A~087129~001~AA~Approved Prior to Jan 1, 1982~No~RX~PAR PHARMACEUTICAL INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~PIONEER PH
ARMS~4MG~A~087839~001~~Feb 8, 1984~No~DISCN~PIONEER PHARMACEUTICALS INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~PLIVA~4MG~
A~088205~001~~Jul 26, 1983~No~DISCN~PLIVA INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~SANDOZ~4MG
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~STASON PHA

RMS~4MG~A~040644~001~AA~May 30, 2006~No~RX~STASON PHARMACEUTICALS INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~SUPERPHARM
~4MG~A~087405~001~~Approved Prior to Jan 1, 1982~No~DISCN~SUPERPHARM CORP
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~TG UNITED
LABS~4MG~A~088212~001~~May 26, 1983~No~DISCN~TG UNITED LABS LLC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~VITARINE~4
MG~A~087284~001~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS
INC
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~CYPROHEPTADINE HYDROCHLORIDE~WATSON LAB
S~4MG~A~085245~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES I
NC
NC
NC
AMINOGLUTETHIMIDE~TABLET;ORAL~CYTADREN~NOVARTIS~250MG~N~018202~001~~Approved Pri
LIOTHYRONINE SODIUM~TABLET;ORAL~CYTOMEL~KING PHARMS R AND D~EQ 0.005MG BASE~N~01
0379~001~AB~Approved Prior to Jan 1, 1982~No~RX~KING PHARMACEUTICALS RESEARCH AN
D DEVELOPMENT INC
0379~002~AB~Approved Prior to Jan 1, 1982~No~RX~KING PHARMACEUTICALS RESEARCH AN
D DEVELOPMENT INC
379~003~AB~Approved Prior to Jan 1, 1982~Yes~RX~KING PHARMACEUTICALS RESEARCH AN
D DEVELOPMENT INC
MISOPROSTOL~TABLET;ORAL~CYTOTEC~GD SEARLE LLC~0.1MG~N~019268~003~AB~Sep 21, 1990
~No~RX~GD SEARLE LLC
MISOPROSTOL~TABLET;ORAL~CYTOTEC~GD SEARLE LLC~0.2MG~N~019268~001~AB~Dec 27, 1988
~Yes~RX~GD SEARLE LLC
CYCLOPHOSPHAMIDE~TABLET;ORAL~CYTOXAN~BAXTER HLTHCARE~25MG~N~012141~002~~Approved
Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP
CYCLOPHOSPHAMIDE~TABLET;ORAL~CYTOXAN~BAXTER HLTHCARE~50MG~N~012141~001~~Approved
Prior to Jan 1, 1982~No~DISCN~BAXTER HEALTHCARE CORP
ROFLUMILAST~TABLET;ORAL~DALIRESP~FOREST RES INST INC~500MCG~N~022522~001~~Feb 28
, 2011~Yes~RX~FOREST RESEARCH INSTITUTE INC
DAPSONE~TABLET;ORAL~DAPSONE~JACOBUS~25MG~A~086841~001~~Approved Prior to Jan 1,
1982~No~RX~JACOBUS PHARMACEUTICAL CO
DAPSONE~TABLET;ORAL~DAPSONE~JACOBUS~100MG~A~086842~001~~Approved Prior to Jan 1,
1982~Yes~RX~JACOBUS PHARMACEUTICAL CO
DICHLORPHENAMIDE~TABLET;ORAL~DARANIDE~TARO~50MG **Federal Register determination
that product was not discontinued or withdrawn for safety or efficacy reasons**
~N~011366~001~~Approved Prior to Jan 1, 1982~No~DISCN~TARO PHARMACEUTICALS USA I
NC
PYRIMETHAMINE~TABLET;ORAL~DARAPRIM~AMEDRA PHARMS~25MG~N~008578~001~~Approved Pri
or to Jan 1, 1982~Yes~RX~AMEDRA PHARMACEUTICALS LLC
ISOPROPAMIDE IODIDE~TABLET;ORAL~DARBID~GLAXOSMITHKLINE~EQ 5MG BASE~N~010744~001~
OXYPHENCYCLIMINE HYDROCHLORIDE~TABLET;ORAL~DARICON~PFIZER~10MG~N~011612~001~~App
roved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE~TABLET;ORAL~DARVOCET~AAIPHARMA LLC~325
MG;32.5MG~N~016844~001~~Approved Prior to Jan 1, 1982~No~DISCN~AAIPHARMA LLC
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE~TABLET;ORAL~DARVOCET A500~XANODYNE PHARM~5
00MG;100MG~A~076429~001~~Sep 10, 2003~No~DISCN~XANODYNE PHARMACEUTICS INC
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE~TABLET;ORAL~DARVOCET-N 100~XANODYNE PHARM~
650MG;100MG~N~017122~002~~Approved Prior to Jan 1, 1982~No~DISCN~XANODYNE PHARMA
CEUTICS INC
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE~TABLET;ORAL~DARVOCET-N 50~XANODYNE PHARM~3

25MG;50MG~N~017122~001~~Approved Prior to Jan 1, 1982~No~DISCN~XANODYNE PHARMACE
UTICS INC
PROPOXYPHENE NAPSYLATE~TABLET;ORAL~DARVON-N~XANODYNE PHARM~100MG~N~016862~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~XANODYNE PHARMACEUTICS INC
ASPIRIN; PROPOXYPHENE NAPSYLATE~TABLET;ORAL~DARVON-N W/ ASA~AAIPHARMA LLC~325MG;
100MG~N~016863~001~~Approved Prior to Jan 1, 1982~No~DISCN~AAIPHARMA LLC
OXAPROZIN~TABLET;ORAL~DAYPRO~GD SEARLE~600MG~N~018841~004~AB~Oct 29, 1992~Yes~RX
~GD SEARLE LLC
OXAPROZIN POTASSIUM~TABLET;ORAL~DAYPRO ALTA~GD SEARLE~600MG~N~020776~001~~Oct 17
, 2002~No~DISCN~GD SEARLE LLC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~DAYSEE~LUPIN LTD~0.03MG,0.01MG;0.1
5MG,N/A~A~091467~001~AB~Apr 10, 2013~No~RX~LUPIN LTD
DESMOPRESSIN ACETATE~TABLET;ORAL~DDAVP~FERRING PHARMS INC~0.1MG~N~019955~001~AB~
Sep 6, 1995~No~RX~FERRING PHARMACEUTICALS INC
DESMOPRESSIN ACETATE~TABLET;ORAL~DDAVP~FERRING PHARMS INC~0.2MG~N~019955~002~AB~
Sep 6, 1995~Yes~RX~FERRING PHARMACEUTICALS INC
DEXAMETHASONE~TABLET;ORAL~DECADRON~MERCK~0.25MG **Federal Register determination
~N~011664~004~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
that product was not discontinued or withdrawn for safety or efficacy reasons**~
N~011664~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
~N~011664~002~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
DEXAMETHASONE~TABLET;ORAL~DECADRON~MERCK~1.5MG~N~011664~003~~Approved Prior to J
an 1, 1982~No~DISCN~MERCK AND CO INC
DEXAMETHASONE~TABLET;ORAL~DECADRON~MERCK~4MG~N~011664~005~~Approved Prior to Jan
1, 1982~No~DISCN~MERCK AND CO INC
DEXAMETHASONE~TABLET;ORAL~DECADRON~MERCK~6MG~N~011664~006~~Jul 30, 1982~No~DISCN
~MERCK AND CO INC
DOXYLAMINE SUCCINATE~TABLET;ORAL~DECAPRYN~SANOFI AVENTIS US~12.5MG~N~006412~015~
~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
DOXYLAMINE SUCCINATE~TABLET;ORAL~DECAPRYN~SANOFI AVENTIS US~25MG~N~006412~014~~A
pproved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DECLOMYCIN~COREPHARMA~75MG~N~050261~001
~~Approved Prior to Jan 1, 1982~No~DISCN~COREPHARMA LLC
2~~Approved Prior to Jan 1, 1982~No~DISCN~COREPHARMA LLC
3~~Approved Prior to Jan 1, 1982~No~DISCN~COREPHARMA LLC
METHOCARBAMOL~TABLET;ORAL~DELAXIN~FERNDALE LABS~500MG~A~085454~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
TAMINE SULFATE~TABLET;ORAL~DELCOBESE~TEVA~1.25MG;1.25MG;1.25MG;1.25MG~A~083563~0
TAMINE SULFATE~TABLET;ORAL~DELCOBESE~TEVA~2.5MG;2.5MG;2.5MG;2.5MG~A~083563~003~~
TAMINE SULFATE~TABLET;ORAL~DELCOBESE~TEVA~3.75MG;3.75MG;3.75MG;3.75MG~A~083563~0
TAMINE SULFATE~TABLET;ORAL~DELCOBESE~TEVA~5MG;5MG;5MG;5MG~A~083563~001~~Approved
PREDNISOLONE~TABLET;ORAL~DELTA-CORTEF~PHARMACIA AND UPJOHN~5MG~N~009987~004~~App
roved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
PREDNISONE~TABLET;ORAL~DELTA-DOME~BAYER PHARMS~5MG~A~080293~001~~Approved Prior
to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
PREDNISONE~TABLET;ORAL~DELTASONE~PHARMACIA AND UPJOHN~2.5MG~N~009986~005~~Approv

ed Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
PREDNISONE~TABLET;ORAL~DELTASONE~PHARMACIA AND UPJOHN~5MG~N~009986~002~~Approved
Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
PREDNISONE~TABLET;ORAL~DELTASONE~PHARMACIA AND UPJOHN~10MG~N~009986~006~~Approve
d Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
TORSEMIDE~TABLET;ORAL~DEMADEX~MEDA PHARMS~5MG~N~020136~001~AB~Aug 23, 1993~No~RX
~MEDA PHARMACEUTICALS INC
TORSEMIDE~TABLET;ORAL~DEMADEX~MEDA PHARMS~10MG~N~020136~002~AB~Aug 23, 1993~No~R
X~MEDA PHARMACEUTICALS INC
TORSEMIDE~TABLET;ORAL~DEMADEX~MEDA PHARMS~20MG~N~020136~003~AB~Aug 23, 1993~Yes~
RX~MEDA PHARMACEUTICALS INC
TORSEMIDE~TABLET;ORAL~DEMADEX~MEDA PHARMS~100MG~N~020136~004~AB~Aug 23, 1993~No~
RX~MEDA PHARMACEUTICALS INC
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DEMECLOCYCLINE HYDROCHLORIDE~AMNEAL PHA
RM~150MG~A~065425~001~AB~Feb 27, 2008~No~RX~AMNEAL PHARMACEUTICAL
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DEMECLOCYCLINE HYDROCHLORIDE~AMNEAL PHA
RM~300MG~A~065425~002~AB~Feb 27, 2008~Yes~RX~AMNEAL PHARMACEUTICAL
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DEMECLOCYCLINE HYDROCHLORIDE~BARR~150MG
~A~065171~001~AB~Dec 13, 2004~No~RX~BARR LABORATORIES INC
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DEMECLOCYCLINE HYDROCHLORIDE~BARR~300MG
~A~065171~002~AB~Dec 13, 2004~No~RX~BARR LABORATORIES INC
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DEMECLOCYCLINE HYDROCHLORIDE~IMPAX LABS
~150MG~A~065094~001~AB~Mar 22, 2004~No~RX~IMPAX LABORATORIES INC
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DEMECLOCYCLINE HYDROCHLORIDE~IMPAX LABS
~300MG~A~065094~002~AB~Mar 22, 2004~No~RX~IMPAX LABORATORIES INC
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DEMECLOCYCLINE HYDROCHLORIDE~VERSAPHARM
~150MG~A~065389~001~AB~Dec 1, 2008~No~RX~VERSAPHARM INC
DEMECLOCYCLINE HYDROCHLORIDE~TABLET;ORAL~DEMECLOCYCLINE HYDROCHLORIDE~VERSAPHARM
~300MG~A~065389~002~AB~Dec 1, 2008~No~RX~VERSAPHARM INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~DEMEROL~SANOFI AVENTIS US~50MG~N~005010~001
~AA~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~DEMEROL~SANOFI AVENTIS US~100MG~N~005010~00
4~AA~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
CHLORTHALIDONE; RESERPINE~TABLET;ORAL~DEMI-REGROTON~SANOFI AVENTIS US~25MG;0.125
MG~N~015103~002~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
PENICILLAMINE~TABLET;ORAL~DEPEN~MEDA PHARMS~250MG~N~019854~001~~Approved Prior t
o Jan 1, 1982~Yes~RX~MEDA PHARMACEUTICALS INC
DESIPRAMINE HYDROCHLORIDE~TABLET;ORAL~DESIPRAMINE HYDROCHLORIDE~ACTAVIS TOTOWA~1
0MG~A~074430~001~AB~Feb 9, 1996~No~RX~ACTAVIS TOTOWA LLC
5MG~A~071601~001~AB~Jun 5, 1987~No~RX~ACTAVIS TOTOWA LLC
0MG~A~071588~001~AB~Jun 5, 1987~No~RX~ACTAVIS TOTOWA LLC
5MG~A~071602~001~AB~Oct 5, 1987~No~RX~ACTAVIS TOTOWA LLC
00MG~A~071766~001~AB~Oct 5, 1987~No~RX~ACTAVIS TOTOWA LLC
50MG~A~074430~002~AB~Feb 9, 1996~No~RX~ACTAVIS TOTOWA LLC
DESIPRAMINE HYDROCHLORIDE~TABLET;ORAL~DESIPRAMINE HYDROCHLORIDE~ANI PHARMS INC~2
5MG~A~071800~001~~Dec 8, 1987~No~DISCN~ANI PHARMACEUTICALS INC

00MG~A~071803~001~~May 29, 1997~No~DISCN~ANI PHARMACEUTICALS INC
50MG~A~071804~001~~May 29, 1997~No~DISCN~ANI PHARMACEUTICALS INC
DESIPRAMINE HYDROCHLORIDE~TABLET;ORAL~DESIPRAMINE HYDROCHLORIDE~SANDOZ~10MG~A~07
DESIPRAMINE HYDROCHLORIDE~TABLET;ORAL~DESIPRAMINE HYDROCHLORIDE~USL PHARMA~25MG~
A~071864~001~~Sep 9, 1987~No~DISCN~USL PHARMA INC
DESIPRAMINE HYDROCHLORIDE~TABLET;ORAL~DESIPRAMINE HYDROCHLORIDE~USL PHARMA~100MG
~A~071867~001~~Sep 9, 1987~No~DISCN~USL PHARMA INC
DESLORATADINE~TABLET;ORAL~DESLORATADINE~BELCHER PHARMS~5MG~A~078355~001~AB~Apr 1
9, 2012~No~RX~BELCHER PHARMACEUTICALS LLC
DESLORATADINE~TABLET;ORAL~DESLORATADINE~DR REDDYS LABS LTD~5MG~A~078365~001~AB~M
DESLORATADINE~TABLET;ORAL~DESLORATADINE~LUPIN PHARMS~5MG~A~078352~001~AB~Oct 25,
DESLORATADINE~TABLET;ORAL~DESLORATADINE~MYLAN PHARMS INC~5MG~A~078351~001~AB~Feb
DESLORATADINE~TABLET;ORAL~DESLORATADINE~ORCHID HLTHCARE~5MG~A~078357~001~AB~Feb
19, 2010~No~RX~ORCHID HEALTHCARE
DESLORATADINE~TABLET;ORAL~DESLORATADINE~PERRIGO R AND D~5MG~A~078361~001~AB~Dec
22, 2011~No~RX~PERRIGO R AND D CO
DESLORATADINE~TABLET;ORAL~DESLORATADINE~SANDOZ~5MG~A~078364~001~AB~Dec 3, 2010~N
o~RX~SANDOZ INC
DESLORATADINE~TABLET;ORAL~DESLORATADINE~SUN PHARM INDS~5MG~A~078359~001~AB~Nov 1
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~ACTAVIS LABS FL INC~0.1MG~
A~076470~001~AB~Jul 1, 2005~No~RX~ACTAVIS LABORATORIES FL INC
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~ACTAVIS LABS FL INC~0.2MG~
A~076470~002~AB~Jul 1, 2005~No~RX~ACTAVIS LABORATORIES FL INC
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~APOTEX INC~0.1MG~A~077414~
001~AB~Mar 7, 2006~No~RX~APOTEX INC ETOBICOKE SITE
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~APOTEX INC~0.2MG~A~077414~
002~AB~Mar 7, 2006~No~RX~APOTEX INC ETOBICOKE SITE
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~FERRING~0.1MG~N~021795~001
~~May 8, 2008~No~RX~FERRING PHARMACEUTICALS INC
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~FERRING~0.2MG~N~021795~002
~~May 8, 2008~Yes~RX~FERRING PHARMACEUTICALS INC
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~MYLAN PHARMS INC~0.1MG~A~2
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~MYLAN PHARMS INC~0.2MG~A~2
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~TEVA PHARMS~0.1MG~A~077122
~001~AB~Jan 25, 2006~No~RX~TEVA PHARMACEUTICALS USA
DESMOPRESSIN ACETATE~TABLET;ORAL~DESMOPRESSIN ACETATE~TEVA PHARMS~0.2MG~A~077122
~002~AB~Jan 25, 2006~No~RX~TEVA PHARMACEUTICALS USA
METHAMPHETAMINE HYDROCHLORIDE~TABLET;ORAL~DESOXYN~RECORDATI RARE~5MG~N~005378~00

2~AA~Approved Prior to Jan 1, 1982~Yes~RX~RECORDATI RARE DISEASES INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~DESYREL~APOTHECON~50MG~N~018207~001~~Approve
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~DESYREL~APOTHECON~100MG~N~018207~002~~Approv
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~DESYREL~APOTHECON~150MG~N~018207~003~~Mar 25
, 1985~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~DESYREL~APOTHECON~300MG~N~018207~004~~Nov 7,
TOLTERODINE TARTRATE~TABLET;ORAL~DETROL~PHARMACIA AND UPJOHN~1MG~N~020771~001~AB
~Mar 25, 1998~No~RX~PHARMACIA AND UPJOHN CO
TOLTERODINE TARTRATE~TABLET;ORAL~DETROL~PHARMACIA AND UPJOHN~2MG~N~020771~002~AB
~Mar 25, 1998~Yes~RX~PHARMACIA AND UPJOHN CO
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ECR~1.5MG~A~040700~001~AB~Aug 15, 2008~N
o~RX~ECR PHARMACEUTICALS
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~IMPAX LABS~0.75MG~A~085376~001~~Approved
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~MUTUAL PHARM~0.25MG~A~084013~001~~Approv
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~MUTUAL PHARM~0.5MG~A~084084~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~PAR PHARM~0.25MG~A~088149~001~~Apr 28, 1
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~PAR PHARM~0.5MG~A~088148~001~BP~Apr 28,
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~PAR PHARM~4MG~A~088238~001~BP~Apr 28, 19
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~PAR PHARM~6MG~A~088481~001~BP~Nov 28, 19
83~Yes~RX~PAR PHARMACEUTICAL INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~PHOENIX LABS NY~0.75MG~A~083806~001~~App
roved Prior to Jan 1, 1982~No~DISCN~PHOENIX LABORATORIES INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~PVT FORM~0.75MG~A~083420~001~~Approved P
rior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ROXANE~0.25MG~A~084614~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ROXANE~0.5MG~A~084611~001~BP~Approved Pr
ior to Jan 1, 1982~No~RX~ROXANE LABORATORIES INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ROXANE~0.75MG~A~084613~001~BP~Approved P
rior to Jan 1, 1982~No~RX~ROXANE LABORATORIES INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ROXANE~1MG~A~088306~001~BP~Sep 15, 1983~
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ROXANE~1.5MG~A~084610~001~AB~Approved Pr
ior to Jan 1, 1982~No~RX~ROXANE LABORATORIES INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ROXANE~2MG~A~087916~001~BP~Aug 26, 1982~

DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ROXANE~4MG~A~084612~001~BP~Approved Prio
r to Jan 1, 1982~No~RX~ROXANE LABORATORIES INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~ROXANE~6MG~A~088316~001~BP~Sep 15, 1983~
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~SANDOZ~0.75MG~A~080399~001~~Approved Pri
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~UPSHER SMITH~0.75MG~A~087534~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~UPSHER SMITH LABORATORIES INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~UPSHER SMITH~1.5MG~A~087533~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~UPSHER SMITH LABORATORIES INC
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~WATSON LABS~0.25MG~A~085455~001~~Approve
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~WATSON LABS~0.5MG~A~085458~001~~Approved
DEXAMETHASONE~TABLET;ORAL~DEXAMETHASONE~WHITEWORTH TOWN PLSN~0.75MG~A~084327~001
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXAMPEX~TEVA~5MG~A~083735~001~~Approved P
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXAMPEX~TEVA~10MG~A~083735~002~~Approved
DEXCHLORPHENIRAMINE MALEATE~TABLET;ORAL~DEXCHLORPHENIRAMINE MALEATE~ANI PHARMS I
NC~2MG~A~088682~001~~Jan 17, 1986~No~DISCN~ANI PHARMACEUTICALS INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXEDRINE~GLAXOSMITHKLINE~5MG~A~084935~001
~~Approved Prior to Jan 1, 1982~No~DISCN~GLAXOSMITHKLINE
DEXMETHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~DEXMETHYLPHENIDATE HYDROCHLORIDE~TE
VA PHARMS~2.5MG~A~077107~003~AB~Jan 29, 2007~No~RX~TEVA PHARMACEUTICALS USA
VA PHARMS~5MG~A~077107~001~AB~Jan 29, 2007~No~RX~TEVA PHARMACEUTICALS USA
VA PHARMS~10MG~A~077107~002~AB~Jan 29, 2007~No~RX~TEVA PHARMACEUTICALS USA
DEXAMETHASONE~TABLET;ORAL~DEXONE 0.5~SOLVAY~0.5MG~A~084991~001~~Approved Prior t
DEXAMETHASONE~TABLET;ORAL~DEXONE 0.75~SOLVAY~0.75MG~A~084993~001~~Approved Prior
DEXAMETHASONE~TABLET;ORAL~DEXONE 1.5~SOLVAY~1.5MG~A~084990~001~~Approved Prior t
DEXAMETHASONE~TABLET;ORAL~DEXONE 4~SOLVAY~4MG~A~084992~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
AMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP S
ULFATE AND AMP SULFATE~ACTAVIS ELIZABETH~1.25MG;1.25MG;1.25MG;1.25MG~A~040456~00
1~AB~May 6, 2003~No~RX~ACTAVIS ELIZABETH LLC
ULFATE AND AMP SULFATE~ACTAVIS ELIZABETH~2.5MG;2.5MG;2.5MG;2.5MG~A~040456~002~AB
~May 6, 2003~No~RX~ACTAVIS ELIZABETH LLC
ULFATE AND AMP SULFATE~ACTAVIS ELIZABETH~5MG;5MG;5MG;5MG~A~040456~003~AB~May 6,

ULFATE AND AMP SULFATE~ACTAVIS ELIZABETH~7.5MG;7.5MG;7.5MG;7.5MG~A~040456~004~AB
~May 6, 2003~No~RX~ACTAVIS ELIZABETH LLC
ULFATE AND AMP SULFATE~AUROLIFE PHARMA LLC~1.25MG;1.25MG;1.25MG;1.25MG~A~202424~
001~AB~Nov 27, 2013~No~RX~AUROLIFE PHARMA LLC
ULFATE AND AMP SULFATE~AUROLIFE PHARMA LLC~1.875MG;1.875MG;1.875MG;1.875MG~A~202
424~002~AB~Nov 27, 2013~No~RX~AUROLIFE PHARMA LLC
ULFATE AND AMP SULFATE~AUROLIFE PHARMA LLC~2.5MG;2.5MG;2.5MG;2.5MG~A~202424~003~
AB~Nov 27, 2013~No~RX~AUROLIFE PHARMA LLC
ULFATE AND AMP SULFATE~AUROLIFE PHARMA LLC~3.125MG;3.125MG;3.125MG;3.125MG~A~202
424~004~AB~Nov 27, 2013~No~RX~AUROLIFE PHARMA LLC
ULFATE AND AMP SULFATE~AUROLIFE PHARMA LLC~3.75MG;3.75MG;3.75MG;3.75MG~A~202424~
005~AB~Nov 27, 2013~No~RX~AUROLIFE PHARMA LLC
ULFATE AND AMP SULFATE~AUROLIFE PHARMA LLC~5MG;5MG;5MG;5MG~A~202424~006~AB~Nov 2
7, 2013~No~RX~AUROLIFE PHARMA LLC
ULFATE AND AMP SULFATE~AUROLIFE PHARMA LLC~7.5MG;7.5MG;7.5MG;7.5MG~A~202424~007~
AB~Nov 27, 2013~No~RX~AUROLIFE PHARMA LLC
ULFATE AND AMP SULFATE~BARR~1.25MG;1.25MG;1.25MG;1.25MG~A~040422~001~AB~Feb 11,
ULFATE AND AMP SULFATE~BARR~1.875MG;1.875MG;1.875MG;1.875MG~A~040422~005~AB~Mar
19, 2003~No~RX~BARR LABORATORIES INC
ULFATE AND AMP SULFATE~BARR~2.5MG;2.5MG;2.5MG;2.5MG~A~040422~002~AB~Feb 11, 2002
ULFATE AND AMP SULFATE~BARR~3.125MG;3.125MG;3.125MG;3.125MG~A~040422~006~AB~Mar
ULFATE AND AMP SULFATE~BARR~3.75MG;3.75MG;3.75MG;3.75MG~A~040422~007~AB~Mar 19,
ULFATE AND AMP SULFATE~BARR~5MG;5MG;5MG;5MG~A~040422~003~AB~Feb 11, 2002~No~RX~B
ARR LABORATORIES INC
ULFATE AND AMP SULFATE~BARR~7.5MG;7.5MG;7.5MG;7.5MG~A~040422~004~AB~Feb 11, 2002

~Yes~RX~BARR LABORATORIES INC
ULFATE AND AMP SULFATE~COREPHARMA~1.25MG;1.25MG;1.25MG;1.25MG~A~040444~001~AB~Ju
n 19, 2002~No~RX~COREPHARMA LLC
ULFATE AND AMP SULFATE~COREPHARMA~2.5MG;2.5MG;2.5MG;2.5MG~A~040444~002~AB~Jun 19
ULFATE AND AMP SULFATE~COREPHARMA~5MG;5MG;5MG;5MG~A~040444~003~AB~Jun 19, 2002~N
o~RX~COREPHARMA LLC
ULFATE AND AMP SULFATE~COREPHARMA~7.5MG;7.5MG;7.5MG;7.5MG~A~040444~004~AB~Jun 19
ULFATE AND AMP SULFATE~MALLINCKRODT INC~1.25MG;1.25MG;1.25MG;1.25MG~A~040440~001
~AB~Oct 7, 2003~No~RX~MALLINCKRODT INC
ULFATE AND AMP SULFATE~MALLINCKRODT INC~1.875MG;1.875MG;1.875MG;1.875MG~A~040440
~002~AB~Oct 7, 2003~No~RX~MALLINCKRODT INC
ULFATE AND AMP SULFATE~MALLINCKRODT INC~2.5MG;2.5MG;2.5MG;2.5MG~A~040440~003~AB~
Oct 7, 2003~No~RX~MALLINCKRODT INC
ULFATE AND AMP SULFATE~MALLINCKRODT INC~3.125MG;3.125MG;3.125MG;3.125MG~A~040440
~004~AB~Oct 7, 2003~No~RX~MALLINCKRODT INC
ULFATE AND AMP SULFATE~MALLINCKRODT INC~3.75MG;3.75MG;3.75MG;3.75MG~A~040440~005
~AB~Oct 7, 2003~No~RX~MALLINCKRODT INC
ULFATE AND AMP SULFATE~MALLINCKRODT INC~5MG;5MG;5MG;5MG~A~040440~006~AB~Oct 7, 2
ULFATE AND AMP SULFATE~MALLINCKRODT INC~7.5MG;7.5MG;7.5MG;7.5MG~A~040440~007~AB~
Oct 7, 2003~No~RX~MALLINCKRODT INC
ULFATE AND AMP SULFATE~MUTUAL PHARM~1.25MG;1.25MG;1.25MG;1.25MG~A~040480~001~AB~
Sep 9, 2003~No~RX~MUTUAL PHARMACEUTICAL CO INC
ULFATE AND AMP SULFATE~MUTUAL PHARM~1.875MG;1.875MG;1.875MG;1.875MG~A~040480~002
~AB~Sep 9, 2003~No~RX~MUTUAL PHARMACEUTICAL CO INC
ULFATE AND AMP SULFATE~MUTUAL PHARM~2.5MG;2.5MG;2.5MG;2.5MG~A~040480~003~AB~Sep
ULFATE AND AMP SULFATE~MUTUAL PHARM~3.125MG;3.125MG;3.125MG;3.125MG~A~040480~004

~AB~Sep 9, 2003~No~RX~MUTUAL PHARMACEUTICAL CO INC
ULFATE AND AMP SULFATE~MUTUAL PHARM~3.75MG;3.75MG;3.75MG;3.75MG~A~040480~005~AB~
Sep 9, 2003~No~RX~MUTUAL PHARMACEUTICAL CO INC
ULFATE AND AMP SULFATE~MUTUAL PHARM~5MG;5MG;5MG;5MG~A~040480~006~AB~Sep 9, 2003~
ULFATE AND AMP SULFATE~MUTUAL PHARM~7.5MG;7.5MG;7.5MG;7.5MG~A~040480~007~AB~Sep
ULFATE AND AMP SULFATE~SANDOZ~1.25MG;1.25MG;1.25MG;1.25MG~A~040439~004~AB~Sep 27
, 2002~No~RX~SANDOZ INC
ULFATE AND AMP SULFATE~SANDOZ~2.5MG;2.5MG;2.5MG;2.5MG~A~040439~001~AB~Jun 14, 20
02~No~RX~SANDOZ INC
ULFATE AND AMP SULFATE~SANDOZ~5MG;5MG;5MG;5MG~A~040439~002~AB~Jun 14, 2002~No~RX
~SANDOZ INC
ULFATE AND AMP SULFATE~SANDOZ~7.5MG;7.5MG;7.5MG;7.5MG~A~040439~003~AB~Jun 14, 20
02~No~RX~SANDOZ INC
ULFATE AND AMP SULFATE~TEVA PHARMS~1.25MG;1.25MG;1.25MG;1.25MG~A~040472~001~~Sep
ULFATE AND AMP SULFATE~TEVA PHARMS~2.5MG;2.5MG;2.5MG;2.5MG~A~040472~002~~Sep 30,
ULFATE AND AMP SULFATE~TEVA PHARMS~5MG;5MG;5MG;5MG~A~040472~003~~Sep 30, 2003~No
ULFATE AND AMP SULFATE~TEVA PHARMS~7.5MG;7.5MG;7.5MG;7.5MG~A~040472~004~~Sep 30,
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~AUROLIFE PHARMA
LLC~5MG~A~202893~001~AA~Jul 31, 2013~No~RX~AUROLIFE PHARMA LLC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~AUROLIFE PHARMA
LLC~10MG~A~202893~002~AA~Jul 31, 2013~No~RX~AUROLIFE PHARMA LLC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~BARR~5MG~A~04036
1~001~AA~Jan 31, 2001~No~RX~BARR LABORATORIES INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~BARR~10MG~A~0403
61~002~AA~Jan 31, 2001~Yes~RX~BARR LABORATORIES INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~COREPHARMA~5MG~A
~090652~001~AA~Mar 7, 2014~No~RX~COREPHARMA LLC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~COREPHARMA~10MG~
A~090652~002~AA~Mar 7, 2014~No~RX~COREPHARMA LLC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~HALSEY~10MG~A~08
3930~001~~Approved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~LANNETT~5MG~A~08

DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~MALLINCKRODT~5MG
~A~040436~001~AA~Jan 29, 2002~No~RX~MALLINCKRODT INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~MALLINCKRODT~10M
G~A~040436~002~AA~Jan 29, 2002~No~RX~MALLINCKRODT INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~MAST MM~5MG~A~08
6521~001~~Approved Prior to Jan 1, 1982~No~DISCN~MM MAST AND CO
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~MIKART~2.5MG~A~0
90533~001~~Oct 25, 2011~No~RX~MIKART INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~MIKART~5MG~A~090
533~002~AA~Oct 25, 2011~No~RX~MIKART INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~MIKART~7.5MG~A~0
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~NESHER PHARMS~5M
G~A~040365~001~~Oct 31, 2002~No~DISCN~NESHER PHARMACEUTICALS USA LLC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~NESHER PHARMS~10
MG~A~040367~001~~Oct 31, 2002~No~DISCN~NESHER PHARMACEUTICALS USA LLC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~PUREPAC PHARM~5M
G~A~084125~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~SANDOZ~5MG~A~085
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~SANDOZ~10MG~A~08
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~VINTAGE PHARMS L
LC~5MG~A~040299~001~~May 13, 1999~No~DISCN~VINTAGE PHARMACEUTICALS LLC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~VITARINE~5MG~A~0
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROAMPHETAMINE SULFATE~VITARINE~10MG~A~
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROSTAT~SHIRE~5MG~A~084051~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~DEXTROSTAT~SHIRE~10MG~A~084051~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~TABLET;ORAL~DI-ATRO~MD PHARM~0.025
MG;2.5MG~A~085266~001~~Approved Prior to Jan 1, 1982~No~DISCN~MD PHARMACEUTICAL
INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~DI-METREX~PVT FORM~35MG~A~085698~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
GLYBURIDE~TABLET;ORAL~DIABETA~SANOFI AVENTIS US~1.25MG~N~017532~001~BX~May 1, 19
GLYBURIDE~TABLET;ORAL~DIABETA~SANOFI AVENTIS US~2.5MG~N~017532~002~BX~May 1, 198
GLYBURIDE~TABLET;ORAL~DIABETA~SANOFI AVENTIS US~5MG~N~017532~003~BX~May 1, 1984~
Yes~RX~SANOFI AVENTIS US LLC
CHLORPROPAMIDE~TABLET;ORAL~DIABINESE~PFIZER~100MG~N~011641~003~AB~Approved Prior
to Jan 1, 1982~No~RX~PFIZER LABORATORIES DIV PFIZER INC
CHLORPROPAMIDE~TABLET;ORAL~DIABINESE~PFIZER~250MG~N~011641~006~AB~Approved Prior
to Jan 1, 1982~Yes~RX~PFIZER LABORATORIES DIV PFIZER INC

ACETAZOLAMIDE~TABLET;ORAL~DIAMOX~TEVA BRANDED PHARM~125MG **Federal Register det
reasons**~N~008943~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA BRANDED PHA
RMACEUTICAL PRODUCTS R AND D INC
ACETAZOLAMIDE~TABLET;ORAL~DIAMOX~TEVA BRANDED PHARM~250MG **Federal Register det
reasons**~N~008943~002~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA BRANDED PHA
RMACEUTICAL PRODUCTS R AND D INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~ACTAVIS ELIZABETH~2MG~A~070781~001~~Mar 19, 1986~N
o~DISCN~ACTAVIS ELIZABETH LLC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~ACTAVIS ELIZABETH~5MG~A~070706~001~~Mar 19, 1986~N
o~DISCN~ACTAVIS ELIZABETH LLC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~ACTAVIS ELIZABETH~10MG~A~070707~001~~Mar 19, 1986~
DIAZEPAM~TABLET;ORAL~DIAZEPAM~BARR~2MG~A~070152~001~AB~Nov 1, 1985~No~RX~BARR LA
BORATORIES INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~BARR~10MG~A~070154~001~AB~Nov 1, 1985~No~RX~BARR L
ABORATORIES INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~DAVA PHARMS INC~2MG~A~070226~001~~Sep 26, 1985~No~
DIAZEPAM~TABLET;ORAL~DIAZEPAM~DAVA PHARMS INC~5MG~A~070227~001~~Sep 26, 1985~No~
DIAZEPAM~TABLET;ORAL~DIAZEPAM~DAVA PHARMS INC~10MG~A~070228~001~~Sep 26, 1985~No
~DISCN~DAVA PHARMACEUTICALS INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~DURAMED PHARMS BARR~2MG~A~070894~001~~Aug 27, 1986
~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~FERNDALE LABS~2MG~A~070903~001~~Apr 1, 1987~No~DIS
CN~FERNDALE LABORATORIES INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~FERNDALE LABS~5MG~A~070904~001~~Apr 1, 1987~No~DIS
CN~FERNDALE LABORATORIES INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~FERNDALE LABS~10MG~A~070905~001~~Apr 1, 1987~No~DI
SCN~FERNDALE LABORATORIES INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~HALSEY~2MG~A~070987~001~~Aug 15, 1986~No~DISCN~HAL
SEY DRUG CO INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~HALSEY~5MG~A~070996~001~~Aug 15, 1986~No~DISCN~HAL
SEY DRUG CO INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~HALSEY~10MG~A~070956~001~~Aug 15, 1986~No~DISCN~HA
LSEY DRUG CO INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~IVAX SUB TEVA PHARMS~2MG~A~070360~001~~Sep 4, 1985
~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
DIAZEPAM~TABLET;ORAL~DIAZEPAM~IVAX SUB TEVA PHARMS~2MG~A~071307~001~AB~Dec 10, 1
~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
DIAZEPAM~TABLET;ORAL~DIAZEPAM~IVAX SUB TEVA PHARMS~5MG~A~071321~001~AB~Dec 10, 1
DIAZEPAM~TABLET;ORAL~DIAZEPAM~IVAX SUB TEVA PHARMS~10MG~A~071322~001~AB~Dec 10,
DIAZEPAM~TABLET;ORAL~DIAZEPAM~MARTEC USA LLC~10MG~A~072402~001~~Apr 25, 1989~No~
DISCN~MARTEC USA LLC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~MYLAN~2MG~A~070325~002~AB~Sep 4, 1985~No~RX~MYLAN
PHARMACEUTICALS INC
PHARMACEUTICALS INC
PHARMACEUTICALS INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~PAR PHARM~2MG~A~070462~001~~Feb 25, 1986~No~DISCN~
DIAZEPAM~TABLET;ORAL~DIAZEPAM~PAR PHARM~5MG~A~070463~001~~Feb 25, 1986~No~DISCN~
DIAZEPAM~TABLET;ORAL~DIAZEPAM~PAR PHARM~10MG~A~070464~001~~Feb 25, 1986~No~DISCN
DIAZEPAM~TABLET;ORAL~DIAZEPAM~PIONEER PHARMS~2MG~A~070787~001~~Aug 2, 1988~No~DI
SCN~PIONEER PHARMACEUTICALS INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~PIONEER PHARMS~5MG~A~070788~001~~Aug 2, 1988~No~DI
SCN~PIONEER PHARMACEUTICALS INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~PIONEER PHARMS~10MG~A~070776~001~~Aug 2, 1988~No~D
ISCN~PIONEER PHARMACEUTICALS INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~ROXANE~2MG~A~070356~001~~Jun 17, 1986~No~DISCN~ROX
DIAZEPAM~TABLET;ORAL~DIAZEPAM~ROXANE~5MG~A~070357~001~~Jun 17, 1986~No~DISCN~ROX
DIAZEPAM~TABLET;ORAL~DIAZEPAM~ROXANE~10MG~A~070358~001~~Jun 17, 1986~No~DISCN~RO
DIAZEPAM~TABLET;ORAL~DIAZEPAM~SANDOZ~2MG~A~070302~001~~Dec 20, 1985~No~DISCN~SAN
DOZ INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~SANDOZ~5MG~A~070303~001~~Dec 20, 1985~No~DISCN~SAN
DOZ INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~SANDOZ~10MG~A~070304~001~~Dec 20, 1985~No~DISCN~SA
NDOZ INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~TEVA PHARMS~5MG~A~070153~001~~Nov 1, 1985~No~DISCN
DIAZEPAM~TABLET;ORAL~DIAZEPAM~VINTAGE PHARMS~2MG~A~077749~001~AB~Mar 31, 2006~No
~RX~VINTAGE PHARMACEUTICALS INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~VINTAGE PHARMS~5MG~A~077749~002~AB~Mar 31, 2006~No
~RX~VINTAGE PHARMACEUTICALS INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~VINTAGE PHARMS~10MG~A~077749~003~AB~Mar 31, 2006~N
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WARNER CHILCOTT~2MG~A~070209~001~~Sep 4, 1985~No~D
ISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WARNER CHILCOTT~5MG~A~070210~001~~Sep 4, 1985~No~D
ISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WARNER CHILCOTT~10MG~A~070222~001~~Sep 4, 1985~No~
DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WATSON LABS~2MG~A~070456~001~~Nov 1, 1985~No~DISCN
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WATSON LABS~2MG~A~071134~001~AB~Feb 3, 1987~No~RX~
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WATSON LABS~5MG~A~070457~001~~Nov 1, 1985~No~DISCN
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WATSON LABS~5MG~A~071135~001~AB~Feb 3, 1987~No~RX~
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WATSON LABS~10MG~A~070458~001~~Nov 1, 1985~No~DISC
N~WATSON LABORATORIES INC
DIAZEPAM~TABLET;ORAL~DIAZEPAM~WATSON LABS~10MG~A~071136~001~AB~Feb 3, 1987~No~RX
DICLOFENAC POTASSIUM~TABLET;ORAL~DICLOFENAC POTASSIUM~APOTEX~50MG~A~076561~001~A
B~Mar 18, 2004~No~RX~APOTEX INC
DICLOFENAC POTASSIUM~TABLET;ORAL~DICLOFENAC POTASSIUM~MUTUAL PHARM~50MG~A~075470
~001~~Feb 21, 2002~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DICLOFENAC POTASSIUM~TABLET;ORAL~DICLOFENAC POTASSIUM~MYLAN~50MG~A~075463~001~AB
~Jul 26, 1999~No~RX~MYLAN PHARMACEUTICALS INC
DICLOFENAC POTASSIUM~TABLET;ORAL~DICLOFENAC POTASSIUM~SANDOZ~50MG~A~075229~001~A
B~Nov 20, 1998~No~RX~SANDOZ INC

DICLOFENAC POTASSIUM~TABLET;ORAL~DICLOFENAC POTASSIUM~SANDOZ~50MG~A~075582~001~~
Feb 23, 2001~No~DISCN~SANDOZ INC
DICLOFENAC POTASSIUM~TABLET;ORAL~DICLOFENAC POTASSIUM~TEVA~50MG~A~075219~001~AB~
Aug 6, 1998~No~RX~TEVA PHARMACEUTICALS USA INC
DICLOFENAC POTASSIUM~TABLET;ORAL~DICLOFENAC POTASSIUM~WATSON LABS~50MG~A~075152~
001~~Nov 27, 1998~No~DISCN~WATSON LABORATORIES INC
DICUMAROL~TABLET;ORAL~DICUMAROL~ABBVIE~25MG~N~005545~003~~Approved Prior to Jan
DICYCLOMINE HYDROCHLORIDE~TABLET;ORAL~DICYCLOMINE HYDROCHLORIDE~HIKMA PHARMS LLC
~20MG~A~040161~001~~Oct 1, 1996~No~DISCN~HIKMA PHARMACEUTICALS LLC
DICYCLOMINE HYDROCHLORIDE~TABLET;ORAL~DICYCLOMINE HYDROCHLORIDE~LANNETT~20MG~A~0
40230~001~AB~Feb 26, 1999~No~RX~LANNETT CO INC
DICYCLOMINE HYDROCHLORIDE~TABLET;ORAL~DICYCLOMINE HYDROCHLORIDE~MUTUAL PHARM~20M
G~A~084600~001~~Jul 29, 1985~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DICYCLOMINE HYDROCHLORIDE~TABLET;ORAL~DICYCLOMINE HYDROCHLORIDE~MYLAN~20MG~A~040
DICYCLOMINE HYDROCHLORIDE~TABLET;ORAL~DICYCLOMINE HYDROCHLORIDE~PIONEER PHARMS~2
0MG~A~088585~001~~Aug 20, 1986~No~DISCN~PIONEER PHARMACEUTICALS INC
DICYCLOMINE HYDROCHLORIDE~TABLET;ORAL~DICYCLOMINE HYDROCHLORIDE~WATSON LABS~20MG
DICYCLOMINE HYDROCHLORIDE~TABLET;ORAL~DICYCLOMINE HYDROCHLORIDE~WATSON LABS~20MG
~A~085223~001~AB~Jul 30, 1986~No~RX~WATSON LABORATORIES INC
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~DIDREX~PHARMACIA AND UPJOHN~25MG~N~01242
BENZPHETAMINE HYDROCHLORIDE~TABLET;ORAL~DIDREX~PHARMACIA AND UPJOHN~50MG~N~01242
7~002~AA~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
ETIDRONATE DISODIUM~TABLET;ORAL~DIDRONEL~PROCTER AND GAMBLE~200MG~N~017831~001~A
B~Approved Prior to Jan 1, 1982~No~RX~PROCTER AND GAMBLE PHARMACEUTICALS INC SUB
PROCTER AND GAMBLE CO
ETIDRONATE DISODIUM~TABLET;ORAL~DIDRONEL~PROCTER AND GAMBLE~400MG~N~017831~002~A
B~Approved Prior to Jan 1, 1982~Yes~RX~PROCTER AND GAMBLE PHARMACEUTICALS INC SU
B PROCTER AND GAMBLE CO
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~AVANTHI IN
C~25MG~A~201212~001~AA~Dec 22, 2010~No~RX~AVANTHI INC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~COREPHARMA
~25MG~A~040828~001~AA~Nov 5, 2008~No~RX~COREPHARMA LLC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~LANNETT HO
LDINGS INC~25MG~A~200177~001~AA~Jul 18, 2011~No~RX~LANNETT HOLDINGS INC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~SANDOZ~25M
G~A~085916~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~TEVA~25MG~
A~088642~001~~Sep 20, 1984~No~DISCN~TEVA PHARMACEUTICALS USA INC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~TG UNITED
LABS~25MG~A~088267~001~~Aug 25, 1983~No~DISCN~TG UNITED LABS LLC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~TG UNITED
LABS~25MG~A~088268~001~~Aug 25, 1983~No~DISCN~TG UNITED LABS LLC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~UCB INC~25
MG~A~085544~001~~Approved Prior to Jan 1, 1982~No~DISCN~UCB INC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~DIETHYLPROPION HYDROCHLORIDE~WATSON LAB
INC
DIETHYLSTILBESTROL~TABLET;ORAL~DIETHYLSTILBESTROL~LILLY~0.1MG~N~004041~002~~Appr
DIETHYLSTILBESTROL~TABLET;ORAL~DIETHYLSTILBESTROL~LILLY~0.5MG~N~004041~003~~Appr
DIETHYLSTILBESTROL~TABLET;ORAL~DIETHYLSTILBESTROL~LILLY~1MG~N~004041~004~~Approv
DIETHYLSTILBESTROL~TABLET;ORAL~DIETHYLSTILBESTROL~LILLY~5MG~N~004041~005~~Approv
FIDAXOMICIN~TABLET;ORAL~DIFICID~CUBIST PHARMS~200MG~N~201699~001~~May 27, 2011~Y
es~RX~CUBIST PHARMACEUTICALS INC
FLUCONAZOLE~TABLET;ORAL~DIFLUCAN~PFIZER~50MG~N~019949~001~AB~Jan 29, 1990~No~RX~
PFIZER CENTRAL RESEARCH
FLUCONAZOLE~TABLET;ORAL~DIFLUCAN~PFIZER~100MG~N~019949~002~AB~Jan 29, 1990~No~RX
~PFIZER CENTRAL RESEARCH
FLUCONAZOLE~TABLET;ORAL~DIFLUCAN~PFIZER~150MG~N~019949~004~AB~Jun 30, 1994~No~RX
~PFIZER CENTRAL RESEARCH
FLUCONAZOLE~TABLET;ORAL~DIFLUCAN~PFIZER~200MG~N~019949~003~AB~Jan 29, 1990~Yes~R
X~PFIZER CENTRAL RESEARCH
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~EMCURE PHARMS USA~500MG~A~202845~001~AB~Mar 8,
2012~No~RX~EMCURE PHARMACEUTICALS USA INC
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~PUREPAC PHARM~250MG~A~074285~001~~May 7, 1996~
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~PUREPAC PHARM~500MG~A~074285~002~~May 7, 1996~
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~ROXANE~250MG~A~073562~001~~Nov 27, 1992~No~DIS
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~ROXANE~500MG~A~073563~001~~Nov 27, 1992~No~DIS
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~SANDOZ~500MG~A~074604~001~~Jun 10, 1996~No~DIS
CN~SANDOZ INC
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~TEVA~250MG~A~073679~001~~Jul 31, 1992~No~DISCN
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~TEVA~500MG~A~073673~001~AB~Jul 31, 1992~Yes~RX
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~WATSON LABS~250MG~A~074400~001~~Jul 17, 1997~N
DIFLUNISAL~TABLET;ORAL~DIFLUNISAL~WATSON LABS~500MG~A~074400~002~~Jul 17, 1997~N
DIGOXIN~TABLET;ORAL~DIGOXIN~HIKMA INTL PHARMS~0.125MG~A~077002~002~AB~Oct 30, 20
DIGOXIN~TABLET;ORAL~DIGOXIN~HIKMA INTL PHARMS~0.25MG~A~077002~001~AB~Oct 30, 200
DIGOXIN~TABLET;ORAL~DIGOXIN~IMPAX LABS~0.125MG~A~078556~001~AB~Jul 20, 2009~No~R
X~IMPAX LABORATORIES INC
DIGOXIN~TABLET;ORAL~DIGOXIN~IMPAX LABS~0.25MG~A~078556~002~AB~Jul 20, 2009~No~RX
DIGOXIN~TABLET;ORAL~DIGOXIN~MYLAN PHARMS INC~0.125MG~A~040282~001~AB~Dec 23, 199
DIGOXIN~TABLET;ORAL~DIGOXIN~MYLAN PHARMS INC~0.25MG~A~040282~002~AB~Dec 23, 1999
DIGOXIN~TABLET;ORAL~DIGOXIN~STEVENS J~0.125MG~A~076268~001~AB~Jul 26, 2002~No~RX
~JEROME STEVENS PHARMACEUTICALS INC
DIGOXIN~TABLET;ORAL~DIGOXIN~STEVENS J~0.25MG~A~076268~002~AB~Jul 26, 2002~No~RX~
JEROME STEVENS PHARMACEUTICALS INC
DIGOXIN~TABLET;ORAL~DIGOXIN~SUN PHARM INDS INC~0.125MG~A~076363~001~AB~Jan 31, 2
DIGOXIN~TABLET;ORAL~DIGOXIN~SUN PHARM INDS INC~0.25MG~A~076363~002~AB~Jan 31, 20
HYDROMORPHONE HYDROCHLORIDE~TABLET;ORAL~DILAUDID~PURDUE PHARM PRODS~2MG~N~019892
~003~AB~Nov 9, 2007~No~RX~PURDUE PHARMACEUTICAL PRODUCTS LP
~002~AB~Nov 9, 2007~No~RX~PURDUE PHARMACEUTICAL PRODUCTS LP
~001~AB~Dec 7, 1992~Yes~RX~PURDUE PHARMACEUTICAL PRODUCTS LP
DYPHYLLINE~TABLET;ORAL~DILOR~SAVAGE LABS~200MG~A~084514~001~~Approved Prior to J

an 1, 1982~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
DYPHYLLINE~TABLET;ORAL~DILOR-400~SAVAGE LABS~400MG~A~084751~001~~Approved Prior
to Jan 1, 1982~No~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~APOTHECON~30MG~A~074
051~001~~Mar 31, 1993~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~DAVA PHARMS INC~30MG
~A~074093~001~~Nov 5, 1992~No~DISCN~DAVA PHARMACEUTICALS INC
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~DAVA PHARMS INC~120M
G~A~074093~004~~Nov 5, 1992~No~DISCN~DAVA PHARMACEUTICALS INC
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~IVAX SUB TEVA PHARMS
ACEUTICALS USA
ACEUTICALS USA
ACEUTICALS USA
~120MG~A~074168~004~~Mar 3, 1995~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHAR
MACEUTICALS USA
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~MYLAN~30MG~A~072838~
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~MYLAN~120MG~A~072838
~001~AB~Nov 5, 1992~No~RX~MYLAN PHARMACEUTICALS INC
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~TEVA~30MG~A~074084~0
01~AB~May 31, 1995~No~RX~TEVA PHARMACEUTICALS USA INC
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~TEVA~120MG~A~074185~
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~TEVA PHARMS~30MG~A~0
74067~001~~Nov 5, 1992~No~DISCN~TEVA PHARMACEUTICALS USA
DILTIAZEM HYDROCHLORIDE~TABLET;ORAL~DILTIAZEM HYDROCHLORIDE~TEVA PHARMS~120MG~A~
DIMENHYDRINATE~TABLET;ORAL~DIMENHYDRINATE~HEATHER~50MG~A~080841~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
DIMENHYDRINATE~TABLET;ORAL~DIMENHYDRINATE~NEXGEN PHARMA INC~50MG~A~085985~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
DIMENHYDRINATE~TABLET;ORAL~DIMENHYDRINATE~WATSON LABS~50MG~A~085166~001~~Approve
BROMPHENIRAMINE MALEATE~TABLET;ORAL~DIMETANE~WYETH CONS~4MG~N~010799~003~~Approv
ed Prior to Jan 1, 1982~No~DISCN~WYETH CONSUMER HEALTHCARE
VALSARTAN~TABLET;ORAL~DIOVAN~NOVARTIS~40MG~N~021283~004~AB~Aug 14, 2002~No~RX~NO
VALSARTAN~TABLET;ORAL~DIOVAN~NOVARTIS~80MG~N~021283~001~AB~Jul 18, 2001~No~RX~NO
VALSARTAN~TABLET;ORAL~DIOVAN~NOVARTIS~160MG~N~021283~002~AB~Jul 18, 2001~No~RX~N
OVARTIS PHARMACEUTICALS CORP
VALSARTAN~TABLET;ORAL~DIOVAN~NOVARTIS~320MG~N~021283~003~AB~Jul 18, 2001~Yes~RX~
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~DIOVAN HCT~NOVARTIS~12.5MG;80MG~N~020
818~001~AB~Mar 6, 1998~No~RX~NOVARTIS PHARMACEUTICALS CORP
0818~002~AB~Mar 6, 1998~No~RX~NOVARTIS PHARMACEUTICALS CORP
0818~004~AB~Apr 28, 2006~No~RX~NOVARTIS PHARMACEUTICALS CORP
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~DIOVAN HCT~NOVARTIS~25MG;160MG~N~0208
18~003~AB~Jan 17, 2002~No~RX~NOVARTIS PHARMACEUTICALS CORP
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~DIOVAN HCT~NOVARTIS~25MG;320MG~N~0208
18~005~AB~Apr 28, 2006~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~TABLET;ORAL~DIPHENOXYLATE HYDROCHL
ORIDE AND ATROPINE SULFATE~ABLE~0.025MG;2.5MG~A~040395~001~~Nov 27, 2000~No~DISC
N~ABLE LABORATORIES INC
ORIDE AND ATROPINE SULFATE~ASCOT~0.025MG;2.5MG~A~087934~001~~Jul 19, 1983~No~DIS
CN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
ORIDE AND ATROPINE SULFATE~HEATHER~0.025MG;2.5MG~A~086798~001~~Approved Prior to
Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
ORIDE AND ATROPINE SULFATE~HIKMA PHARMS LLC~0.025MG;2.5MG~A~087765~001~~Mar 15,
1982~No~DISCN~HIKMA PHARMACEUTICALS LLC
ORIDE AND ATROPINE SULFATE~INWOOD LABS~0.025MG;2.5MG~A~085509~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
ORIDE AND ATROPINE SULFATE~IVAX PHARMS~0.025MG;2.5MG~A~086727~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
ORIDE AND ATROPINE SULFATE~KV PHARM~0.025MG;2.5MG~A~085659~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
ORIDE AND ATROPINE SULFATE~LANNETT~0.025MG;2.5MG~A~085372~001~AA~Approved Prior
to Jan 1, 1982~No~RX~LANNETT CO INC
ORIDE AND ATROPINE SULFATE~LEDERLE~0.025MG;2.5MG~A~086950~001~~Approved Prior to
Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
ORIDE AND ATROPINE SULFATE~MUTUAL PHARM~0.025MG;2.5MG~A~085506~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
ORIDE AND ATROPINE SULFATE~MYLAN~0.025MG;2.5MG~A~085762~001~AA~Approved Prior to
ORIDE AND ATROPINE SULFATE~PAR PHARM~0.025MG;2.5MG~A~040357~001~AA~May 2, 2000~N

o~RX~PAR PHARMACEUTICAL INC
ORIDE AND ATROPINE SULFATE~PARKE DAVIS~0.025MG;2.5MG~A~087131~001~~Approved Prio
ORIDE AND ATROPINE SULFATE~PVT FORM~0.025MG;2.5MG~A~085766~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
ORIDE AND ATROPINE SULFATE~R AND S PHARMA~0.025MG;2.5MG~A~085035~001~~Approved P
rior to Jan 1, 1982~No~DISCN~R AND S PHARMA INC
ORIDE AND ATROPINE SULFATE~ROXANE~0.025MG;2.5MG~A~086057~001~~Approved Prior to
Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
ORIDE AND ATROPINE SULFATE~SANDOZ~0.025MG;2.5MG~A~086173~001~~Approved Prior to
Jan 1, 1982~No~DISCN~SANDOZ INC
ORIDE AND ATROPINE SULFATE~USL PHARMA~0.025MG;2.5MG~A~087842~001~~Mar 29, 1982~N
o~DISCN~USL PHARMA INC
ORIDE AND ATROPINE SULFATE~VALEANT PHARM INTL~0.025MG;2.5MG~A~087195~001~~Feb 16
, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
ORIDE AND ATROPINE SULFATE~WATSON LABS~0.025MG;2.5MG~A~085876~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~BARR~25MG~A~087184~001~AB~Oct 3, 1990~No~R
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~GLENMARK GENERICS~25MG~A~088999~001~~Feb 5
, 1991~No~DISCN~GLENMARK GENERICS INC USA
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~IMPAX LABS~25MG~A~040782~001~AB~Jul 18, 20
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~LANNETT~25MG~A~040898~001~AB~Apr 23, 2008~
No~RX~LANNETT HOLDINGS INC
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~MURTY PHARMS~25MG~A~040733~001~AB~Feb 13,
2007~No~RX~MURTY PHARMACEUTICALS INC
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~PROSAM LABS~25MG~A~040542~001~~Apr 21, 200

DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~PUREPAC PHARM~25MG~A~089425~001~AB~Jul 12,
1990~No~RX~PUREPAC PHARMACEUTICAL CO
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~PUREPAC PHARM~50MG~A~089426~001~~Jul 12, 1
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~PUREPAC PHARM~75MG~A~089427~001~~Jul 12, 1
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~SANDOZ~25MG~A~086944~002~~Apr 16, 1991~No~
DISCN~SANDOZ INC
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~SANDOZ~50MG~A~087562~001~~Feb 25, 1992~No~
DISCN~SANDOZ INC
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~SANDOZ~75MG~A~087561~001~~Feb 25, 1992~No~
DISCN~SANDOZ INC
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~WATSON LABS~50MG~A~087160~001~~Jun 7, 1996
DIPYRIDAMOLE~TABLET;ORAL~DIPYRIDAMOLE~ZYDUS PHARMS USA INC~25MG~A~040874~001~AB~
Jan 28, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
ORPHENADRINE HYDROCHLORIDE~TABLET;ORAL~DISIPAL~3M~50MG~N~010653~001~~Approved Pr
DEXBROMPHENIRAMINE MALEATE~TABLET;ORAL~DISOMER~SCHERING~2MG~N~011814~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE~TABLET;ORAL~DISOPHROL~SCHERI
NG~2MG;60MG~N~012394~002~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP S
UB SCHERING PLOUGH CORP
DISULFIRAM~TABLET;ORAL~DISULFIRAM~MYLAN PHARMS INC~250MG~A~203916~001~AB~Mar 4,
DISULFIRAM~TABLET;ORAL~DISULFIRAM~MYLAN PHARMS INC~500MG~A~203916~002~AB~Mar 4,
DISULFIRAM~TABLET;ORAL~DISULFIRAM~PAR PHARM~250MG~A~088792~001~~Aug 14, 1984~No~
DISCN~PAR PHARMACEUTICAL INC
DISULFIRAM~TABLET;ORAL~DISULFIRAM~PAR PHARM~500MG~A~088793~001~~Aug 14, 1984~No~
DISCN~PAR PHARMACEUTICAL INC
DISULFIRAM~TABLET;ORAL~DISULFIRAM~ROXANE~250MG~A~202652~001~AB~Feb 5, 2014~No~RX
DISULFIRAM~TABLET;ORAL~DISULFIRAM~ROXANE~500MG~A~202652~002~AB~Feb 5, 2014~No~RX
DISULFIRAM~TABLET;ORAL~DISULFIRAM~SIGMAPHARM LABS LLC~250MG~A~091619~001~AB~Mar
28, 2011~No~RX~SIGMAPHARM LABORATORIES LLC
DISULFIRAM~TABLET;ORAL~DISULFIRAM~SIGMAPHARM LABS LLC~500MG~A~091619~002~AB~Mar
28, 2011~No~RX~SIGMAPHARM LABORATORIES LLC
DISULFIRAM~TABLET;ORAL~DISULFIRAM~VINTAGE PHARMS~250MG~A~091563~001~AB~Dec 31, 2
DISULFIRAM~TABLET;ORAL~DISULFIRAM~VINTAGE PHARMS~500MG~A~091563~002~AB~Dec 31, 2
DISULFIRAM~TABLET;ORAL~DISULFIRAM~WATSON LABS~250MG~A~086889~001~~Approved Prior
to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
DISULFIRAM~TABLET;ORAL~DISULFIRAM~WATSON LABS~250MG~A~087973~001~~Aug 5, 1983~No
DISULFIRAM~TABLET;ORAL~DISULFIRAM~WATSON LABS~500MG~A~086890~001~~Approved Prior
DISULFIRAM~TABLET;ORAL~DISULFIRAM~WATSON LABS~500MG~A~087974~001~~Aug 5, 1983~No
DISULFIRAM~TABLET;ORAL~DISULFIRAM ~ALVOGEN PINE BROOK~250MG~A~091681~001~AB~Aug
8, 2013~No~RX~ALVOGEN PINE BROOK INC
OXYBUTYNIN CHLORIDE~TABLET;ORAL~DITROPAN~JANSSEN PHARMS~5MG~N~017577~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~JANSSEN PHARMACEUTICALS INC

HYDROFLUMETHIAZIDE~TABLET;ORAL~DIUCARDIN~WYETH AYERST~50MG~A~083383~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
METOLAZONE~TABLET;ORAL~DIULO~GD SEARLE LLC~2.5MG~N~018535~001~~Approved Prior to
Jan 1, 1982~No~DISCN~GD SEARLE LLC
METOLAZONE~TABLET;ORAL~DIULO~GD SEARLE LLC~5MG~N~018535~002~~Approved Prior to J
an 1, 1982~No~DISCN~GD SEARLE LLC
METOLAZONE~TABLET;ORAL~DIULO~GD SEARLE LLC~10MG~N~018535~003~~Approved Prior to
Jan 1, 1982~No~DISCN~GD SEARLE LLC
CHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~DIUPRES-250~MERCK~250MG;0.125MG~N~011635~0
03~~Aug 26, 1987~No~DISCN~MERCK AND CO INC
CHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~DIUPRES-500~MERCK~500MG;0.125MG~N~011635~0
06~~Aug 26, 1987~No~DISCN~MERCK AND CO INC
CHLOROTHIAZIDE~TABLET;ORAL~DIURIL~OAK PHARMS AKORN~250MG~N~011145~004~~Approved
Prior to Jan 1, 1982~No~DISCN~OAK PHARMACEUTICALS INC SUB AKORN INC
CHLOROTHIAZIDE~TABLET;ORAL~DIURIL~OAK PHARMS AKORN~500MG~N~011145~002~~Approved
Prior to Jan 1, 1982~No~DISCN~OAK PHARMACEUTICALS INC SUB AKORN INC
METHYCLOTHIAZIDE; RESERPINE~TABLET;ORAL~DIUTENSEN-R~MEDPOINTE PHARM HLC~2.5MG;0.
1MG~N~012708~005~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICA
LS MEDPOINTE HEALTHCARE INC
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE~TABLET;ORAL~DOLENE AP-65~LEDERLE~650MG
;65MG~A~085100~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES
DIFLUNISAL~TABLET;ORAL~DOLOBID~MERCK~250MG **Federal Register determination that
product was not discontinued or withdrawn for safety or efficacy reasons**~N~01
8445~001~~Apr 19, 1982~No~DISCN~MERCK AND CO INC
DIFLUNISAL~TABLET;ORAL~DOLOBID~MERCK~500MG~N~018445~002~~Apr 19, 1982~No~DISCN~M
ERCK AND CO INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~DOLOPHINE HYDROCHLORIDE~ROXANE~5MG~N~006134~
002~AA~Approved Prior to Jan 1, 1982~Yes~RX~ROXANE LABORATORIES INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~DOLOPHINE HYDROCHLORIDE~ROXANE~10MG~N~006134
~010~AA~Approved Prior to Jan 1, 1982~Yes~RX~ROXANE LABORATORIES INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~ACCORD HLTHCARE~5MG~
A~201335~001~~Aug 29, 2011~No~DISCN~ACCORD HEALTHCARE INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~ACCORD HLTHCARE~10MG
~A~201335~002~~Aug 29, 2011~No~DISCN~ACCORD HEALTHCARE INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~ALEMBIC PHARMS LTD~5
MG~A~201724~001~AB~Feb 25, 2013~No~RX~ALEMBIC PHARMACEUTICALS LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~ALEMBIC PHARMS LTD~1
0MG~A~201724~002~AB~Feb 25, 2013~No~RX~ALEMBIC PHARMACEUTICALS LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~APOTEX~5MG~A~078841~
001~AB~Jun 2, 2011~No~RX~APOTEX INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~APOTEX~10MG~A~078841
~002~AB~Jun 2, 2011~No~RX~APOTEX INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~AUROBINDO~5MG~A~0900
56~001~AB~May 31, 2011~No~RX~AUROBINDO PHARMA LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~AUROBINDO~10MG~A~090
056~002~AB~May 31, 2011~No~RX~AUROBINDO PHARMA LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~CIPLA LTD~5MG~A~0775
18~001~AB~May 31, 2011~No~RX~CIPLA LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~CIPLA LTD~10MG~A~077
518~002~AB~May 31, 2011~No~RX~CIPLA LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~CSPC OUYI PHARM CO~5
MG~A~202114~001~AB~Jul 5, 2013~No~RX~CSPC OUYI PHARMACEUTICAL CO LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~CSPC OUYI PHARM CO~1
0MG~A~202114~002~AB~Jul 5, 2013~No~RX~CSPC OUYI PHARMACEUTICAL CO LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~DR REDDYS LABS LTD~5
MG~A~201001~001~AB~May 31, 2011~No~RX~DR REDDYS LABORATORIES LTD
0MG~A~201001~002~AB~May 31, 2011~No~RX~DR REDDYS LABORATORIES LTD

3MG~A~202723~001~AB~Jul 24, 2013~No~RX~DR REDDYS LABORATORIES LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~HETERO LABS LTD V~5M
G~A~203034~001~AB~Jan 30, 2015~No~RX~HETERO LABS LTD UNIT V
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~HETERO LABS LTD V~10
MG~A~203034~002~AB~Jan 30, 2015~No~RX~HETERO LABS LTD UNIT V
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~HIKMA PHARMS~5MG~A~0
90247~001~AB~May 31, 2011~No~RX~HIKMA PHARMACEUTICALS
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~HIKMA PHARMS~10MG~A~
090247~002~AB~May 31, 2011~No~RX~HIKMA PHARMACEUTICALS
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~INDICUS PHARMA~5MG~A
~201634~001~AB~Jun 13, 2012~No~RX~INDICUS PHARMA LLC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~INDICUS PHARMA~10MG~
A~201634~002~AB~Jun 13, 2012~No~RX~INDICUS PHARMA LLC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~JUBILANT GENERICS~5M
G~A~090768~001~AB~May 31, 2011~No~RX~JUBILANT GENERICS LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~JUBILANT GENERICS~10
MG~A~090768~002~AB~May 31, 2011~No~RX~JUBILANT GENERICS LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~MACLEODS PHARMS LTD~
5MG~A~201146~001~AB~Aug 17, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
10MG~A~201146~002~AB~Aug 17, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
23MG~A~202631~001~AB~Jan 22, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~MYLAN PHARMS INC~5MG
~A~090521~001~AB~May 31, 2011~No~RX~MYLAN PHARMACEUTICALS INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~MYLAN PHARMS INC~10M
G~A~090521~002~AB~May 31, 2011~No~RX~MYLAN PHARMACEUTICALS INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~PAR PHARM~23MG~A~202
542~001~AB~Jul 24, 2013~No~RX~PAR PHARMACEUTICAL INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~PLIVA HRVATSKA DOO~5
MG~A~090425~001~AB~May 31, 2011~No~RX~PLIVA HRVATSKA DOO
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~PLIVA HRVATSKA DOO~1
0MG~A~090425~002~AB~May 31, 2011~No~RX~PLIVA HRVATSKA DOO
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~PRINSTON INC~5MG~A~2
00292~001~AB~May 31, 2011~No~RX~PRINSTON PHARMACEUTICAL INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~PRINSTON INC~10MG~A~
200292~002~AB~May 31, 2011~No~RX~PRINSTON PHARMACEUTICAL INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~RANBAXY~5MG~A~076786
~001~AB~Nov 26, 2010~No~RX~RANBAXY LABORATORIES LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~RANBAXY~10MG~A~07678
6~002~AB~Nov 26, 2010~No~RX~RANBAXY LABORATORIES LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~ROXANE~5MG~A~078662~
001~AB~May 31, 2011~No~RX~ROXANE LABORATORIES INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~ROXANE~10MG~A~078662
~002~AB~May 31, 2011~No~RX~ROXANE LABORATORIES INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~SANDOZ~5MG~A~090290~
001~AB~May 31, 2011~No~RX~SANDOZ INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~SANDOZ~10MG~A~090290
~002~AB~May 31, 2011~No~RX~SANDOZ INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~SCIEGEN PHARMS INC~5
MG~A~203907~001~AB~Oct 29, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~SCIEGEN PHARMS INC~1
0MG~A~203907~002~AB~Oct 29, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~SUN PHARM INDS~5MG~A
~090493~001~AB~May 31, 2011~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~SUN PHARM INDS~10MG~
A~090493~002~AB~May 31, 2011~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~TEVA~5MG~A~077344~00
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~TEVA~10MG~A~077344~0

DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~TORRENT PHARMS~5MG~A
~090686~001~AB~May 31, 2011~No~RX~TORRENT PHARMACEUTICALS LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~TORRENT PHARMS~10MG~
A~090686~002~AB~May 31, 2011~No~RX~TORRENT PHARMACEUTICALS LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~TWI PHARMS INC~23MG~
A~203104~001~AB~Oct 29, 2014~No~RX~TWI PHARMACEUTICALS INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~VIVIMED LABS~5MG~A~0
90551~001~AB~May 31, 2011~No~RX~VIVIMED LABS ALATHUR PRIVATE LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~VIVIMED LABS~10MG~A~
090551~002~AB~May 31, 2011~No~RX~VIVIMED LABS ALATHUR PRIVATE LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~WOCKHARDT~5MG~A~0912
67~001~AB~May 31, 2011~No~RX~WOCKHARDT LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~WOCKHARDT~10MG~A~091
267~002~AB~May 31, 2011~No~RX~WOCKHARDT LTD
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~ZYDUS PHARMS USA INC
~5MG~A~090100~001~AB~Oct 24, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
DONEPEZIL HYDROCHLORIDE~TABLET;ORAL~DONEPEZIL HYDROCHLORIDE~ZYDUS PHARMS USA INC
~10MG~A~090100~002~AB~Oct 24, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
LEVODOPA~TABLET;ORAL~DOPAR~SHIRE~250MG~N~016913~004~~Approved Prior to Jan 1, 19
LEVODOPA~TABLET;ORAL~DOPAR~SHIRE~500MG~N~016913~005~~Approved Prior to Jan 1, 19
QUAZEPAM~TABLET;ORAL~DORAL~SCIECURE PHARMA INC~7.5MG~N~018708~003~~Feb 26, 1987~
No~DISCN~SCIECURE PHARMA INC
QUAZEPAM~TABLET;ORAL~DORAL~SCIECURE PHARMA INC~15MG~N~018708~001~~Dec 27, 1985~Y
es~RX~SCIECURE PHARMA INC
GLUTETHIMIDE~TABLET;ORAL~DORIDEN~SANOFI AVENTIS US~250MG~N~009519~002~~Approved
GLUTETHIMIDE~TABLET;ORAL~DORIDEN~SANOFI AVENTIS US~500MG~N~009519~005~~Approved
MEBUTAMATE~TABLET;ORAL~DORMATE~MEDPOINTE PHARM HLC~600MG~N~017374~001~~Approved
Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
CABERGOLINE~TABLET;ORAL~DOSTINEX~PHARMACIA AND UPJOHN~0.5MG~N~020664~001~~Dec 23
ISONIAZID~TABLET;ORAL~DOW-ISONIAZID~DOW PHARM~300MG~A~080330~002~~Approved Prior
to Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL CORP SUB DOW CHEMICAL CO
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~ACCORD HLTHCARE~EQ 1MG BASE~A~
202824~001~AB~Jun 11, 2014~No~RX~ACCORD HEALTHCARE INC
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~ACTAVIS ELIZABETH~EQ 1MG BASE~
A~075574~001~~Oct 18, 2000~No~DISCN~ACTAVIS ELIZABETH LLC
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~APOTEX~EQ 1MG BASE~A~075580~00

DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~DAVA PHARMS INC~EQ 1MG BASE~A~
076161~001~AB~Jun 10, 2004~No~RX~DAVA PHARMACEUTICALS INC
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~GENPHARM~EQ 1MG BASE~A~075466~
001~~Oct 18, 2000~No~DISCN~GENPHARM INC
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~IVAX SUB TEVA PHARMS~EQ 1MG BA
SE~A~075453~001~~Oct 18, 2000~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMAC
EUTICALS USA
EUTICALS USA
EUTICALS USA
EUTICALS USA
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~MYLAN~EQ 1MG BASE~A~075509~001
~AB~Oct 19, 2000~No~RX~MYLAN PHARMACEUTICALS INC
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~NESHER PHARMS~EQ 1MG BASE~A~07
5609~001~~Oct 18, 2000~No~DISCN~NESHER PHARMACEUTICALS USA LLC
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~PLIVA~EQ 1MG BASE~A~075750~001
~AB~Jun 8, 2001~No~RX~PLIVA INC
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~SANDOZ~EQ 1MG BASE~A~075432~00

DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~TEVA~EQ 1MG BASE~A~075353~001~
~Jan 12, 2001~No~DISCN~TEVA PHARMACEUTICALS USA INC
DOXAZOSIN MESYLATE~TABLET;ORAL~DOXAZOSIN MESYLATE~WATSON LABS INC~EQ 1MG BASE~A~
DOXEPIN HYDROCHLORIDE~TABLET;ORAL~DOXEPIN HYDROCHLORIDE~ACTAVIS ELIZABETH~EQ 3MG
BASE~A~201951~001~AB~Jul 26, 2013~No~RX~ACTAVIS ELIZABETH LLC
DOXEPIN HYDROCHLORIDE~TABLET;ORAL~DOXEPIN HYDROCHLORIDE~ACTAVIS ELIZABETH~EQ 6MG
BASE~A~201951~002~AB~Jul 26, 2013~No~RX~ACTAVIS ELIZABETH LLC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXY-LEMMON~TEVA~EQ 100MG BASE~A~062581~001~~Mar
DOXYLAMINE SUCCINATE~TABLET;ORAL~DOXY-SLEEP-AID~PAR PHARM~25MG~A~070156~001~~Jul
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~HERITAGE PHARMS INC~EQ 50MG BASE~A~091605~00
1~AB~Dec 20, 2011~No~RX~HERITAGE PHARMACEUTICALS INC
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~LANNETT~EQ 50MG BASE~A~065285~001~AB~Dec 8,
2005~No~RX~LANNETT HOLDINGS INC
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~LANNETT~EQ 75MG BASE~A~065285~003~AB~Jul 30,
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~LANNETT~EQ 100MG BASE~A~065285~002~AB~Dec 8,
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~LANNETT~EQ 150MG BASE~A~065285~004~AB~Jul 30
, 2008~No~RX~LANNETT HOLDINGS INC
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~MUTUAL PHARM~EQ 50MG BASE~A~065471~001~~Apr
17, 2009~No~DISCN~MUTUAL PHARMACEUTICAL COMPANY, INC.

DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~MYLAN~EQ 50MG BASE~A~065377~001~AB~Nov 7, 20
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~MYLAN~EQ 150MG BASE~A~065427~001~AB~Jun 7, 2
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~PAR PHARM~EQ 50MG BASE~A~065070~001~AB~Dec 1
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~PAR PHARM~EQ 75MG BASE~A~065070~003~AB~Dec 3
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~PAR PHARM~EQ 100MG BASE~A~065070~002~AB~Dec
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~PAR PHARM~EQ 150MG BASE~A~065070~004~AB~Jul
14, 2005~Yes~RX~PAR PHARMACEUTICAL INC
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~RANBAXY~EQ 50MG BASE~A~065356~001~AB~May 31,
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~RANBAXY~EQ 75MG BASE~A~065356~002~AB~May 31,
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~RANBAXY~EQ 100MG BASE~A~065356~003~AB~May 31
DOXYCYCLINE~TABLET;ORAL~DOXYCYCLINE~SANDOZ INC~EQ 50MG BASE~A~065353~001~~Nov 27
, 2006~No~DISCN~SANDOZ INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~ACTAVIS LABS FL INC~EQ 100MG
BASE~A~062421~001~AB~Feb 2, 1983~No~RX~ACTAVIS LABORATORIES FL INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~BLU CARIBE INC~EQ 50MG BASE~
A~062269~003~~Approved Prior to Jan 1, 1982~No~DISCN~BLU CARIBE INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~BLU CARIBE INC~EQ 100MG BASE
~A~062269~002~AB~Nov 8, 1982~No~RX~BLU CARIBE INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~CHARTWELL LIFE SCI~EQ 100MG
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~COREPHARMA~EQ 20MG BASE~A~06
5182~001~AB~May 13, 2005~No~RX~COREPHARMA LLC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~HEATHER~EQ 100MG BASE~A~0624
62~001~~May 11, 1983~No~DISCN~HEATHER DRUG CO INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~HIKMA INTL PHARMS~EQ 100MG B
ASE~A~065095~001~AB~Jul 2, 2003~Yes~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~INTERPHARM~EQ 100MG BASE~A~0
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~IVAX SUB TEVA PHARMS~EQ 20MG
BASE~A~065163~001~AB~May 13, 2005~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~LANNETT~EQ 20MG BASE~A~06527
7~001~AB~Nov 10, 2005~Yes~RX~LANNETT HOLDINGS INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~LARKEN LABS~EQ 20MG BASE~A~0
65287~001~AB~Feb 28, 2006~No~RX~LARKEN LABORATORIES INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~MUTUAL PHARM~EQ 100MG BASE~A
~062391~001~~Sep 30, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~MUTUAL PHARM~EQ 100MG BASE~A
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~MUTUAL PHARMA~EQ 20MG BASE~A
~065134~001~AB~May 13, 2005~No~RX~MUTUAL PHARMACAL CO

DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~MYLAN~EQ 100MG BASE~A~062432
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~SUPERPHARM~EQ 100MG BASE~A~0
62494~001~~Feb 20, 1985~No~DISCN~SUPERPHARM CORP
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~VINTAGE PHARMS~EQ 100MG BASE
~A~062538~001~AB~Apr 7, 1986~No~RX~VINTAGE PHARMACEUTICALS INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~WARNER CHILCOTT~EQ 100MG BAS
E~A~062593~001~~Aug 28, 1985~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~WATSON LABS~EQ 50MG BASE~A~0
DOXYCYCLINE HYCLATE~TABLET;ORAL~DOXYCYCLINE HYCLATE~WATSON LABS~EQ 100MG BASE~A~
DOXYLAMINE SUCCINATE~TABLET;ORAL~DOXYLAMINE SUCCINATE~COPLEY PHARM~25MG~A~088900
~002~~Feb 12, 1988~No~DISCN~COPLEY PHARMACEUTICAL INC
DOXYLAMINE SUCCINATE~TABLET;ORAL~DOXYLAMINE SUCCINATE~LNK~25MG~A~040564~001~~Aug
27, 2004~No~OTC~LNK INTERNATIONAL INC
DOXYLAMINE SUCCINATE~TABLET;ORAL~DOXYLAMINE SUCCINATE~PERRIGO~25MG~A~040167~001~
~Sep 18, 1996~No~OTC~L PERRIGO CO
DOXYLAMINE SUCCINATE~TABLET;ORAL~DOXYLAMINE SUCCINATE~QUANTUM PHARMICS~25MG~A~08
8603~001~~Aug 7, 1984~No~DISCN~QUANTUM PHARMICS LTD
HYDRALAZINE HYDROCHLORIDE; RESERPINE~TABLET;ORAL~DRALSERP~SANDOZ~25MG;0.1MG~A~08
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~DRALZINE~TEVA~25MG~A~084301~001~~Approved
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL~DROSPIRENONE AND ETHINYL ESTRADIOL~B
ARR~3MG;0.02MG~A~078515~001~AB~Mar 30, 2009~No~RX~BARR LABORATORIES INC
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL~DROSPIRENONE AND ETHINYL ESTRADIOL~W
ATSON LABS~3MG;0.02MG~A~078833~001~AB~Nov 28, 2011~No~RX~WATSON LABORATORIES INC
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED~TABLET;ORAL~DUAVEE~WYETH PHARMS PFIZ
ER~EQ 20MG BASE;0.45MG~N~022247~001~~Oct 3, 2013~Yes~RX~WYETH PHARMACEUTICALS IN
C WHOLLY OWNED SUB PFIZER INC
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~DUETACT~TAKEDA PHARMS USA~2M
G;30MG~N~021925~001~AB~Jul 28, 2006~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~DUETACT~TAKEDA PHARMS USA~4M
G;30MG~N~021925~002~AB~Jul 28, 2006~No~RX~TAKEDA PHARMACEUTICALS USA INC
FAMOTIDINE; IBUPROFEN~TABLET;ORAL~DUEXIS~HORIZON PHARMA~26.6MG;800MG~N~022519~00
1~~Apr 23, 2011~Yes~RX~HORIZON PHARMA INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~DURADYNE DHC~FOREST PHARMS~500
MG;5MG~A~087809~001~~Mar 17, 1983~No~DISCN~FOREST PHARMACEUTICALS INC
CEFADROXIL/CEFADROXIL HEMIHYDRATE~TABLET;ORAL~DURICEF~WARNER CHILCOTT~EQ 1GM BAS
E~N~050528~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT INC
LAMIVUDINE; RALTEGRAVIR POTASSIUM~TABLET;ORAL~DUTREBIS~MERCK SHARP DOHME~150MG;E
Q 300MG BASE~N~206510~001~~Feb 6, 2015~Yes~RX~MERCK SHARP AND DOHME CORP
BETHANECHOL CHLORIDE~TABLET;ORAL~DUVOID~WELLSPRING PHARM~10MG~A~086262~001~AA~Ap
proved Prior to Jan 1, 1982~No~RX~WELLSPRING PHARMACEUTICAL CORP
BETHANECHOL CHLORIDE~TABLET;ORAL~DUVOID~WELLSPRING PHARM~25MG~A~086263~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~WELLSPRING PHARMACEUTICAL CORP
BETHANECHOL CHLORIDE~TABLET;ORAL~DUVOID~WELLSPRING PHARM~50MG~A~085882~003~~Appr
oved Prior to Jan 1, 1982~No~DISCN~WELLSPRING PHARMACEUTICAL CORP
ACETOHEXAMIDE~TABLET;ORAL~DYMELOR~LILLY~250MG~N~013378~002~~Approved Prior to Ja
n 1, 1982~No~DISCN~ELI LILLY INDUSTRIES INC
ACETOHEXAMIDE~TABLET;ORAL~DYMELOR~LILLY~500MG~N~013378~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~ELI LILLY INDUSTRIES INC
ERYTHROMYCIN ETHYLSUCCINATE~TABLET;ORAL~E.E.S. 400~ARBOR PHARMS LLC~EQ 400MG BAS
E~A~061905~001~~Approved Prior to Jan 1, 1982~No~DISCN~ARBOR PHARMACEUTICALS LLC
ERYTHROMYCIN ETHYLSUCCINATE~TABLET;ORAL~E.E.S. 400~ARBOR PHARMS LLC~EQ 400MG BAS
E~A~061905~002~BX~Aug 12, 1982~Yes~RX~ARBOR PHARMACEUTICALS LLC
AZILSARTAN KAMEDOXOMIL~TABLET;ORAL~EDARBI~ARBOR PHARMS IRELAND~EQ 40MG MEDOXOMIL
~N~200796~001~~Feb 25, 2011~No~RX~ARBOR PHARMACEUTICALS IRELAND LTD
AZILSARTAN KAMEDOXOMIL~TABLET;ORAL~EDARBI~ARBOR PHARMS IRELAND~EQ 80MG MEDOXOMIL

~N~200796~002~~Feb 25, 2011~Yes~RX~ARBOR PHARMACEUTICALS IRELAND LTD
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE~TABLET;ORAL~EDARBYCLOR~ARBOR PHARMS IRELA
ND~EQ 40MG MEDOXOMIL;12.5MG~N~202331~001~~Dec 20, 2011~No~RX~ARBOR PHARMACEUTICA
LS IRELAND LTD
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE~TABLET;ORAL~EDARBYCLOR~ARBOR PHARMS IRELA
ND~EQ 40MG MEDOXOMIL;25MG~N~202331~002~~Dec 20, 2011~Yes~RX~ARBOR PHARMACEUTICAL
S IRELAND LTD
ETHACRYNIC ACID~TABLET;ORAL~EDECRIN~ATON~25MG~N~016092~001~~Approved Prior to Ja
n 1, 1982~Yes~RX~ATON PHARMA INC
ETHACRYNIC ACID~TABLET;ORAL~EDECRIN~ATON~50MG~N~016092~002~~Approved Prior to Ja
n 1, 1982~No~DISCN~ATON PHARMA INC
RILPIVIRINE HYDROCHLORIDE~TABLET;ORAL~EDURANT~JANSSEN PRODS~EQ 25MG BASE~N~20202
2~001~~May 20, 2011~Yes~RX~JANSSEN PRODUCTS LP
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~EFFEXOR~WYETH PHARMS INC~EQ 12.5MG BASE **
r safety or efficacy reasons**~N~020151~001~~Dec 28, 1993~No~DISCN~WYETH PHARMAC
EUTICALS INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~EFFEXOR~WYETH PHARMS INC~EQ 25MG BASE **Fe
safety or efficacy reasons**~N~020151~002~~Dec 28, 1993~No~DISCN~WYETH PHARMACEU
TICALS INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~EFFEXOR~WYETH PHARMS INC~EQ 37.5MG BASE **
r safety or efficacy reasons**~N~020151~006~~Dec 28, 1993~No~DISCN~WYETH PHARMAC
EUTICALS INC
TICALS INC
TICALS INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~EFFEXOR~WYETH PHARMS INC~EQ 100MG BASE **F
safety or efficacy reasons**~N~020151~005~~Dec 28, 1993~No~DISCN~WYETH PHARMACE
UTICALS INC
PRASUGREL HYDROCHLORIDE~TABLET;ORAL~EFFIENT~ELI LILLY AND CO~EQ 5MG BASE~N~02230
7~001~~Jul 10, 2009~No~RX~ELI LILLY AND CO
PRASUGREL HYDROCHLORIDE~TABLET;ORAL~EFFIENT~ELI LILLY AND CO~EQ 10MG BASE~N~0223
07~002~~Jul 10, 2009~Yes~RX~ELI LILLY AND CO
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~ELAVIL~ASTRAZENECA~10MG~N~012703~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~ELAVIL~ASTRAZENECA~100MG~N~012703~006~~A
pproved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~ELAVIL~ASTRAZENECA~150MG~N~012703~007~~A
pproved Prior to Jan 1, 1982~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
CALCIUM ACETATE~TABLET;ORAL~ELIPHOS~CYPRESS PHARM~EQ 169MG CALCIUM~A~078502~001~
AB~Nov 25, 2008~Yes~RX~CYPRESS PHARMACEUTICAL INC
APIXABAN~TABLET;ORAL~ELIQUIS~BRISTOL MYERS SQUIBB~2.5MG~N~202155~001~~Dec 28, 20
APIXABAN~TABLET;ORAL~ELIQUIS~BRISTOL MYERS SQUIBB~5MG~N~202155~002~~Dec 28, 2012
~Yes~RX~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
ULIPRISTAL ACETATE~TABLET;ORAL~ELLA~LAB HRA PHARMA~30MG~N~022474~001~~Aug 13, 20

10~Yes~RX~LABORATOIRE HRA PHARMA
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~EMPRACET W/ CODEINE PHOSPHATE #3~GL
AXOSMITHKLINE~300MG;30MG~A~083951~001~~Approved Prior to Jan 1, 1982~No~DISCN~GL
AXOSMITHKLINE
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~EMPRACET W/ CODEINE PHOSPHATE #4~GL
AXOSMITHKLINE~300MG;60MG~A~083951~002~~Approved Prior to Jan 1, 1982~No~DISCN~GL
AXOSMITHKLINE
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~APOTEX~2.5MG~A~075178~002~AB~Mar
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~APOTEX~5MG~A~075178~001~AB~Mar 2
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~APOTEX~10MG~A~075178~003~AB~Mar
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~APOTEX~20MG~A~075178~004~AB~Mar
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~APOTHECON~2.5MG~A~075583~001~~Au
g 22, 2000~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~APOTHECON~5MG~A~075583~002~~Aug
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~IVAX SUB TEVA PHARMS~2.5MG~A~075
482~001~~Aug 22, 2000~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS
USA
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~IVAX SUB TEVA PHARMS~5MG~A~07548
2~002~~Aug 22, 2000~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS U
SA
USA
USA
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~KRKA DD NOVO MESTO~2.5MG~A~07537
0~001~~Aug 22, 2000~No~DISCN~KRKA DD NOVO MESTO
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~KRKA DD NOVO MESTO~5MG~A~075370~
002~~Aug 22, 2000~No~DISCN~KRKA DD NOVO MESTO
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~KRKA DD NOVO MESTO~10MG~A~075369
~001~~Aug 22, 2000~No~DISCN~KRKA DD NOVO MESTO
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~KRKA DD NOVO MESTO~20MG~A~075369
~002~~Aug 22, 2000~No~DISCN~KRKA DD NOVO MESTO
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~MYLAN~2.5MG~A~075472~001~~Aug 22
, 2000~No~DISCN~MYLAN PHARMACEUTICALS INC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~MYLAN~2.5MG~A~075480~001~AB~Aug
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~MYLAN~5MG~A~075472~002~~Aug 22,
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~MYLAN~5MG~A~075480~002~AB~Aug 22
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~RANBAXY~2.5MG~A~075556~001~~Aug

22, 2000~No~DISCN~RANBAXY LABORATORIES LTD
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~RANBAXY~5MG~A~075556~002~~Aug 22
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ~2.5MG~A~075048~001~~Aug 2
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ~5MG~A~075048~002~~Aug 22,
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ~10MG~A~075048~003~~Aug 22
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ~20MG~A~075048~004~~Aug 22
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ INC~2.5MG~A~075496~001~~A
ug 22, 2000~No~DISCN~SANDOZ INC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ INC~2.5MG~A~075621~001~~A
ug 22, 2000~No~DISCN~SANDOZ INC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ INC~5MG~A~075496~002~~Aug
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ INC~5MG~A~075621~002~~Aug
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~SANDOZ INC~10MG~A~075459~001~~Au
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~TARO~2.5MG~A~075657~001~AB~Jan 2
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~TARO~5MG~A~075657~002~AB~Jan 23,
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~TARO~10MG~A~075657~003~AB~Jan 23
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~TARO~20MG~A~075657~004~AB~Jan 23
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~TEVA~2.5MG~A~075479~001~AB~Aug 2
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~TEVA~5MG~A~075479~002~AB~Aug 22,
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~TEVA~10MG~A~075479~003~AB~Aug 22
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~TEVA~20MG~A~075479~004~AB~Aug 22
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~WATSON LABS~2.5MG~A~075501~001~~
Aug 22, 2000~No~DISCN~WATSON LABORATORIES INC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~WATSON LABS~5MG~A~075501~002~~Au
g 22, 2000~No~DISCN~WATSON LABORATORIES INC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~WATSON LABS~10MG~A~075501~003~~A
ug 22, 2000~No~DISCN~WATSON LABORATORIES INC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~WATSON LABS~20MG~A~075501~004~~A
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~WOCKHARDT USA~2.5MG~A~075483~001
~AB~Aug 22, 2000~No~RX~WOCKHARDT USA LLC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~WOCKHARDT USA~5MG~A~075483~002~A
B~Aug 22, 2000~No~RX~WOCKHARDT USA LLC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~WOCKHARDT USA~10MG~A~075483~003~

AB~Aug 22, 2000~No~RX~WOCKHARDT USA LLC
ENALAPRIL MALEATE~TABLET;ORAL~ENALAPRIL MALEATE~WOCKHARDT USA~20MG~A~075483~004~
AB~Aug 22, 2000~No~RX~WOCKHARDT USA LLC
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ENALAPRIL MALEATE AND HYDROCH
LOROTHIAZIDE~APOTEX INC~5MG;12.5MG~A~076486~001~AB~Oct 27, 2004~No~RX~APOTEX INC
ETOBICOKE SITE
LOROTHIAZIDE~APOTEX INC~10MG;25MG~A~076486~002~AB~Oct 27, 2004~No~RX~APOTEX INC
ETOBICOKE SITE
LOROTHIAZIDE~DR REDDYS LABS LTD~5MG;12.5MG~A~075909~001~AB~Oct 15, 2001~No~RX~DR
REDDYS LABORATORIES LTD
LOROTHIAZIDE~DR REDDYS LABS LTD~10MG;25MG~A~075909~002~AB~Oct 15, 2001~No~RX~DR
REDDYS LABORATORIES LTD
LOROTHIAZIDE~IVAX SUB TEVA PHARMS~5MG;12.5MG~A~075736~001~~Mar 25, 2003~No~DISCN
~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
LOROTHIAZIDE~IVAX SUB TEVA PHARMS~10MG;25MG~A~075736~002~~Mar 25, 2003~No~DISCN~
IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
LOROTHIAZIDE~MYLAN~5MG;12.5MG~A~075624~001~AB~Sep 18, 2001~No~RX~MYLAN PHARMACEU
TICALS INC
LOROTHIAZIDE~MYLAN~10MG;25MG~A~075624~002~AB~Sep 18, 2001~No~RX~MYLAN PHARMACEUT
ICALS INC
LOROTHIAZIDE~SANDOZ INC~5MG;12.5MG~A~076116~001~~Sep 19, 2001~No~DISCN~SANDOZ IN
C
LOROTHIAZIDE~SANDOZ INC~10MG;25MG~A~076116~002~~Sep 19, 2001~No~DISCN~SANDOZ INC
LOROTHIAZIDE~TARO PHARM INDS~5MG;12.5MG~A~075788~001~AB~Sep 18, 2001~No~RX~TARO
PHARMACEUTICAL INDUSTRIES LTD
LOROTHIAZIDE~TARO PHARM INDS~10MG;25MG~A~075788~002~AB~Sep 18, 2001~No~RX~TARO P
HARMACEUTICAL INDUSTRIES LTD
LOROTHIAZIDE~TEVA~5MG;12.5MG~A~075727~001~AB~Sep 18, 2001~No~RX~TEVA PHARMACEUTI
CALS USA INC
LOROTHIAZIDE~TEVA~10MG;25MG~A~075727~002~AB~Sep 18, 2001~No~RX~TEVA PHARMACEUTIC
ALS USA INC
AMITRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~ENDEP~ROCHE~10MG~A~083639~001~~Approved
METHYCLOTHIAZIDE~TABLET;ORAL~ENDURON~ABBVIE~2.5MG **Federal Register determinati
**~N~012524~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBVIE INC
METHYCLOTHIAZIDE~TABLET;ORAL~ENDURON~ABBVIE~5MG~N~012524~004~~Approved Prior to
DESERPIDINE; METHYCLOTHIAZIDE~TABLET;ORAL~ENDURONYL~ABBOTT~0.25MG;5MG~N~012775~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PR
ODUCTS DIV
DESERPIDINE; METHYCLOTHIAZIDE~TABLET;ORAL~ENDURONYL FORTE~ABBOTT~0.5MG;5MG~N~012
775~002~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTIC
AL PRODUCTS DIV
ESTROGENS, CONJUGATED SYNTHETIC B~TABLET;ORAL~ENJUVIA~TEVA WOMENS~0.3MG~N~021443
~001~~Dec 20, 2004~No~RX~TEVA WOMENS HEALTH INC
3~002~~Dec 20, 2004~No~RX~TEVA WOMENS HEALTH INC
43~003~~May 10, 2004~No~RX~TEVA WOMENS HEALTH INC
~005~~Apr 27, 2007~No~RX~TEVA WOMENS HEALTH INC
3~004~~May 10, 2004~Yes~RX~TEVA WOMENS HEALTH INC
MESTRANOL; NORETHYNODREL~TABLET;ORAL~ENOVID~GD SEARLE LLC~0.075MG;5MG~N~010976~0
08~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
MESTRANOL; NORETHYNODREL~TABLET;ORAL~ENOVID~GD SEARLE LLC~0.15MG;9.85MG~N~010976
~005~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
ENTACAPONE~TABLET;ORAL~ENTACAPONE~MYLAN PHARMS INC~200MG~A~202394~001~AB~May 13,
ENTACAPONE~TABLET;ORAL~ENTACAPONE~SUN PHARMA GLOBAL~200MG~A~090690~001~AB~Jul 16
, 2012~No~RX~SUN PHARMA GLOBAL FZE
ENTACAPONE~TABLET;ORAL~ENTACAPONE~WOCKHARDT LTD~200MG~A~078941~001~AB~Aug 16, 20
ENTECAVIR~TABLET;ORAL~ENTECAVIR~TEVA PHARMS USA~0.5MG~A~202122~001~AB~Aug 26, 20
ENTECAVIR~TABLET;ORAL~ENTECAVIR~TEVA PHARMS USA~1MG~A~202122~002~AB~Aug 26, 2014
CARBAMAZEPINE~TABLET;ORAL~EPITOL~TEVA~200MG~A~070541~001~AB~Sep 17, 1986~No~RX~T
LAMIVUDINE~TABLET;ORAL~EPIVIR~VIIV HLTHCARE~150MG~N~020564~001~AB~Nov 17, 1995~N
o~RX~VIIV HEALTHCARE CO
LAMIVUDINE~TABLET;ORAL~EPIVIR~VIIV HLTHCARE~300MG~N~020564~003~AB~Jun 24, 2002~Y
es~RX~VIIV HEALTHCARE CO
LAMIVUDINE~TABLET;ORAL~EPIVIR-HBV~GLAXOSMITHKLINE~100MG~N~021003~001~AB~Dec 8, 1
EPLERENONE~TABLET;ORAL~EPLERENONE~APOTEX~25MG~A~078482~001~AB~Jul 30, 2008~No~RX
~APOTEX INC
EPLERENONE~TABLET;ORAL~EPLERENONE~APOTEX~50MG~A~078482~002~AB~Jul 30, 2008~No~RX
~APOTEX INC
EPLERENONE~TABLET;ORAL~EPLERENONE~SANDOZ~25MG~A~078510~001~AB~Aug 1, 2008~No~RX~
SANDOZ INC
EPLERENONE~TABLET;ORAL~EPLERENONE~SANDOZ~50MG~A~078510~002~AB~Aug 1, 2008~No~RX~
SANDOZ INC
EPROSARTAN MESYLATE~TABLET;ORAL~EPROSARTAN MESYLATE~MYLAN PHARMS INC~EQ 400MG BA
SE~A~202012~001~AB~Nov 16, 2011~No~RX~MYLAN PHARMACEUTICALS INC
EPROSARTAN MESYLATE~TABLET;ORAL~EPROSARTAN MESYLATE~MYLAN PHARMS INC~EQ 600MG BA
SE~A~202012~002~AB~Nov 16, 2011~No~RX~MYLAN PHARMACEUTICALS INC
ABACAVIR SULFATE; LAMIVUDINE~TABLET;ORAL~EPZICOM~VIIV HLTHCARE~EQ 600MG BASE;300
MG~N~021652~001~~Aug 2, 2004~Yes~RX~VIIV HEALTHCARE CO
ASPIRIN; MEPROBAMATE~TABLET;ORAL~EQUAGESIC~CARACO~325MG;200MG~N~011702~003~~Dec
29, 1983~No~DISCN~CARACO PHARMACEUTICAL LABORATORIES LTD
MEPROBAMATE~TABLET;ORAL~EQUANIL~WYETH AYERST~200MG~N~010028~005~~Approved Prior
MEPROBAMATE~TABLET;ORAL~EQUANIL~WYETH AYERST~400MG~N~010028~004~~Approved Prior
LEVAMISOLE HYDROCHLORIDE~TABLET;ORAL~ERGAMISOL~JANSSEN PHARMA~EQ 50MG BASE~N~020

035~001~~Jun 18, 1990~No~DISCN~JANSSEN PHARMACEUTICA PRODUCTS LP
ERGOLOID MESYLATES~TABLET;ORAL~ERGOLOID MESYLATES~MUTUAL PHARM~1MG~A~081113~001~
AB~Oct 31, 1991~No~RX~MUTUAL PHARMACEUTICAL CO INC
ERGOLOID MESYLATES~TABLET;ORAL~ERGOLOID MESYLATES~MUTUAL PHARM~1MG~A~088891~001~
~Nov 1, 1985~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
ERGOLOID MESYLATES~TABLET;ORAL~ERGOLOID MESYLATES~WATSON LABS~1MG~A~086433~001~~
May 27, 1982~No~DISCN~WATSON LABORATORIES INC
ERGOLOID MESYLATES~TABLET;ORAL~ERGOLOID MESYLATES~WATSON LABS~1MG~A~087244~001~~
Aug 16, 1982~No~DISCN~WATSON LABORATORIES INC
CAFFEINE; ERGOTAMINE TARTRATE~TABLET;ORAL~ERGOTAMINE TARTRATE AND CAFFEINE~HIKMA
INTL PHARMS~100MG;1MG~A~040510~001~AA~Sep 17, 2004~No~RX~HIKMA INTERNATIONAL PH
ARMACEUTICALS LLC
CAFFEINE; ERGOTAMINE TARTRATE~TABLET;ORAL~ERGOTAMINE TARTRATE AND CAFFEINE~MIKAR
T~100MG;1MG~A~040590~001~AA~Sep 16, 2005~No~RX~MIKART INC
ERLOTINIB HYDROCHLORIDE~TABLET;ORAL~ERLOTINIB HYDROCHLORIDE~MYLAN PHARMS INC~EQ
25MG BASE~A~091002~001~AB~Jun 11, 2014~No~RX~MYLAN PHARMACEUTICALS INC
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYPAR~PARKE DAVIS~EQ 250MG BASE~A~062032~001~
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYPAR~PARKE DAVIS~EQ 500MG BASE~A~062032~002~
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYPAR~WARNER CHILCOTT~EQ 250MG BASE~A~062322~
O
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROCIN STEARATE~ARBOR PHARMS LLC~EQ 125MG
BASE~A~060359~002~~Approved Prior to Jan 1, 1982~No~DISCN~ARBOR PHARMACEUTICALS
LLC
BASE~A~060359~001~~Approved Prior to Jan 1, 1982~Yes~RX~ARBOR PHARMACEUTICALS LL
C
BASE~A~060359~003~~Approved Prior to Jan 1, 1982~No~DISCN~ARBOR PHARMACEUTICALS
LLC
ERYTHROMYCIN~TABLET;ORAL~ERYTHROMYCIN~ARBOR PHARMS LLC~250MG~A~061621~001~~Appro
ved Prior to Jan 1, 1982~No~RX~ARBOR PHARMACEUTICALS LLC
ERYTHROMYCIN~TABLET;ORAL~ERYTHROMYCIN~ARBOR PHARMS LLC~500MG~A~061621~002~~Appro
ved Prior to Jan 1, 1982~Yes~RX~ARBOR PHARMACEUTICALS LLC
ERYTHROMYCIN ETHYLSUCCINATE~TABLET;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~ARBOR PHARMS
LLC~EQ 400MG BASE~A~061904~001~BX~Approved Prior to Jan 1, 1982~Yes~RX~ARBOR PH
ARMACEUTICALS LLC
ERYTHROMYCIN ETHYLSUCCINATE~TABLET;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~BARR~EQ 400M
G BASE~A~062256~001~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES IN
C
ERYTHROMYCIN ETHYLSUCCINATE~TABLET;ORAL~ERYTHROMYCIN ETHYLSUCCINATE~MYLAN~EQ 400
MG BASE~A~062847~001~~Sep 14, 1988~No~DISCN~MYLAN PHARMACEUTICALS INC
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROMYCIN STEARATE~ANI PHARMS INC~EQ 250MG
BASE~A~061461~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANI PHARMACEUTICALS IN
C
C
C
BASE~A~063179~001~~May 15, 1990~No~DISCN~ANI PHARMACEUTICALS INC
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROMYCIN STEARATE~LEDERLE~EQ 250MG BASE~A~

ICAN CYANAMID CO
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROMYCIN STEARATE~LEDERLE~EQ 500MG BASE~A~
ICAN CYANAMID CO
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROMYCIN STEARATE~MYLAN~EQ 250MG BASE~A~06
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROMYCIN STEARATE~MYLAN~EQ 500MG BASE~A~06
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROMYCIN STEARATE~PUREPAC PHARM~EQ 250MG B
ASE~A~061743~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL
CO
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROMYCIN STEARATE~WATSON LABS~EQ 250MG BAS
E~A~062121~002~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
ERYTHROMYCIN STEARATE~TABLET;ORAL~ERYTHROMYCIN STEARATE~WATSON LABS~EQ 500MG BAS
E~A~062121~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~ACCORD HLTHCARE~EQ 5MG BAS
E~A~202389~001~AB~Sep 11, 2012~No~RX~ACCORD HEALTHCARE INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~ACCORD HLTHCARE~EQ 10MG BA
SE~A~202389~002~AB~Sep 11, 2012~No~RX~ACCORD HEALTHCARE INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~ACCORD HLTHCARE~EQ 20MG BA
SE~A~202389~003~AB~Sep 11, 2012~No~RX~ACCORD HEALTHCARE INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~APOTEX INC~EQ 5MG BASE~A~0
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~APOTEX INC~EQ 10MG BASE~A~
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~APOTEX INC~EQ 20MG BASE~A~
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~AUROBINDO PHARMA LTD~EQ 5M
G BASE~A~090432~001~AB~Sep 11, 2012~No~RX~AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~AUROBINDO PHARMA LTD~EQ 10
MG BASE~A~090432~002~AB~Sep 11, 2012~No~RX~AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~AUROBINDO PHARMA LTD~EQ 20
MG BASE~A~090432~003~AB~Sep 11, 2012~No~RX~AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~HIKMA PHARMS~EQ 5MG BASE~A
~078766~001~AB~Sep 11, 2012~No~RX~HIKMA PHARMACEUTICALS
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~HIKMA PHARMS~EQ 10MG BASE~
A~078766~002~AB~Sep 11, 2012~No~RX~HIKMA PHARMACEUTICALS
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~HIKMA PHARMS~EQ 20MG BASE~
A~078766~003~AB~Sep 11, 2012~No~RX~HIKMA PHARMACEUTICALS
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~INVAGEN PHARMS~EQ 5MG BASE
~A~078604~001~AB~Sep 11, 2012~No~RX~INVAGEN PHARMACEUTICALS INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~INVAGEN PHARMS~EQ 10MG BAS
E~A~078604~002~AB~Sep 11, 2012~No~RX~INVAGEN PHARMACEUTICALS INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~INVAGEN PHARMS~EQ 20MG BAS
E~A~078604~003~AB~Sep 11, 2012~No~RX~INVAGEN PHARMACEUTICALS INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~JUBILANT GENERICS~EQ 5MG B
ASE~A~202280~001~AB~Sep 12, 2012~No~RX~JUBILANT GENERICS LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~JUBILANT GENERICS~EQ 10MG
BASE~A~202280~002~AB~Sep 12, 2012~No~RX~JUBILANT GENERICS LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~JUBILANT GENERICS~EQ 20MG
BASE~A~202280~003~AB~Sep 12, 2012~No~RX~JUBILANT GENERICS LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~LUPIN LTD~EQ 5MG BASE~A~07
8169~001~AB~Sep 11, 2012~No~RX~LUPIN LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~MACLEODS PHARMS LTD~EQ 5MG
BASE~A~202210~001~AB~Sep 11, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD

ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~MACLEODS PHARMS LTD~EQ 10M
G BASE~A~202210~002~AB~Sep 11, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~MACLEODS PHARMS LTD~EQ 20M
G BASE~A~202210~003~AB~Sep 11, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~STI PHARMA LLC~EQ 5MG BASE
~A~077512~001~AB~Sep 12, 2012~No~RX~STI PHARMA LLC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~STI PHARMA LLC~EQ 10MG BAS
E~A~077512~002~AB~Sep 12, 2012~No~RX~STI PHARMA LLC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~STI PHARMA LLC~EQ 20MG BAS
E~A~077512~003~AB~Sep 12, 2012~No~RX~STI PHARMA LLC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~TEVA PHARMS USA~EQ 5MG BAS
E~A~076765~001~AB~Mar 14, 2012~No~RX~TEVA PHARMACEUTICALS USA
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~TEVA PHARMS USA~EQ 10MG BA
SE~A~076765~002~AB~Mar 14, 2012~No~RX~TEVA PHARMACEUTICALS USA
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~TEVA PHARMS USA~EQ 20MG BA
SE~A~076765~003~AB~Mar 14, 2012~No~RX~TEVA PHARMACEUTICALS USA
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~TORRENT PHARMS LTD~EQ 5MG
BASE~A~090939~001~AB~Sep 11, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~ZYDUS PHARMS USA INC~EQ 5M
G BASE~A~077734~001~AB~Sep 11, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~ZYDUS PHARMS USA INC~EQ 10
MG BASE~A~077734~002~AB~Sep 11, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
ESCITALOPRAM OXALATE~TABLET;ORAL~ESCITALOPRAM OXALATE~ZYDUS PHARMS USA INC~EQ 20
MG BASE~A~077734~003~AB~Sep 11, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~TABLET;ORAL~ESGIC~FOREST PHARMS~325MG;50MG;4
0MG~A~089660~001~~Dec 23, 1988~No~DISCN~FOREST PHARMACEUTICALS INC
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~TABLET;ORAL~ESGIC-PLUS~MIKART~500MG;50MG;40M
G~A~089451~001~~May 23, 1988~No~DISCN~MIKART INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~ESIDRIX~NOVARTIS~25MG~N~011793~005~~Approved Pri
HYDROCHLOROTHIAZIDE~TABLET;ORAL~ESIDRIX~NOVARTIS~50MG~N~011793~008~~Approved Pri
HYDROCHLOROTHIAZIDE~TABLET;ORAL~ESIDRIX~NOVARTIS~100MG~N~011793~009~~Approved Pr
GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ESIMIL~NOVARTIS~10MG;2
5MG~N~013553~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICAL
S CORP
LITHIUM CARBONATE~TABLET;ORAL~ESKALITH~JDS PHARMS~300MG~N~017971~001~~Approved P
rior to Jan 1, 1982~No~DISCN~JDS PHARMACEUTICALS LLC
ESTAZOLAM~TABLET;ORAL~ESTAZOLAM~PAR PHARM~1MG~A~074826~001~AB~Jul 3, 1997~No~RX~
ESTAZOLAM~TABLET;ORAL~ESTAZOLAM~PAR PHARM~2MG~A~074826~002~AB~Jul 3, 1997~No~RX~
ESTAZOLAM~TABLET;ORAL~ESTAZOLAM~TEVA~1MG~A~074921~001~AB~Jul 10, 1997~No~RX~TEVA
ESTAZOLAM~TABLET;ORAL~ESTAZOLAM~TEVA~2MG~A~074921~002~AB~Jul 10, 1997~Yes~RX~TEV
ESTAZOLAM~TABLET;ORAL~ESTAZOLAM~WATSON LABS~1MG~A~074818~001~AB~Aug 19, 1997~No~
ESTAZOLAM~TABLET;ORAL~ESTAZOLAM~WATSON LABS~2MG~A~074818~002~AB~Aug 19, 1997~No~
ESTROGENS, ESTERIFIED~TABLET;ORAL~ESTERIFIED ESTROGENS~PVT FORM~0.625MG~A~083414
~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
ESTROGENS, ESTERIFIED~TABLET;ORAL~ESTERIFIED ESTROGENS~PVT FORM~1.25MG~A~083765~
001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
ESTROGENS, ESTERIFIED~TABLET;ORAL~ESTERIFIED ESTROGENS~PVT FORM~2.5MG~A~085907~0

ESTROGENS, ESTERIFIED~TABLET;ORAL~ESTERIFIED ESTROGENS~SANDOZ~1.25MG~A~085302~00
ETHINYL ESTRADIOL~TABLET;ORAL~ESTINYL~SCHERING~0.02MG~N~005292~001~~Approved Pri
ETHINYL ESTRADIOL~TABLET;ORAL~ESTINYL~SCHERING~0.05MG~N~005292~002~~Approved Pri
ETHINYL ESTRADIOL~TABLET;ORAL~ESTINYL~SCHERING~0.5MG~N~005292~003~~Approved Prio
r to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
ESTRADIOL~TABLET;ORAL~ESTRACE~BRISTOL MYERS SQUIBB~0.5MG~A~081295~001~~Jun 30, 1
ESTRADIOL~TABLET;ORAL~ESTRACE~BRISTOL MYERS SQUIBB~1MG~A~084499~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INST
ITUTE
ESTRADIOL~TABLET;ORAL~ESTRACE~BRISTOL MYERS SQUIBB~2MG~A~084500~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INST
ITUTE
ESTRADIOL~TABLET;ORAL~ESTRADIOL~BARR LABS INC~0.5MG~A~040197~001~AB~Oct 22, 1997
ESTRADIOL~TABLET;ORAL~ESTRADIOL~BARR LABS INC~1MG~A~040197~002~AB~Oct 22, 1997~N
ESTRADIOL~TABLET;ORAL~ESTRADIOL~BARR LABS INC~2MG~A~040197~003~AB~Oct 22, 1997~Y
es~RX~BARR LABORATORIES INC
ESTRADIOL~TABLET;ORAL~ESTRADIOL~HERITAGE PHARMS INC~0.5MG~A~040275~001~~Dec 29,
ESTRADIOL~TABLET;ORAL~ESTRADIOL~HERITAGE PHARMS INC~1MG~A~040275~002~~Dec 29, 19
ESTRADIOL~TABLET;ORAL~ESTRADIOL~HERITAGE PHARMS INC~2MG~A~040275~003~~Dec 29, 19
ESTRADIOL~TABLET;ORAL~ESTRADIOL~LANNETT HOLDINGS INC~0.5MG~A~040138~001~~Jan 30,
1998~No~DISCN~LANNETT HOLDINGS INC
ESTRADIOL~TABLET;ORAL~ESTRADIOL~LANNETT HOLDINGS INC~1MG~A~040138~002~~Jan 30, 1
ESTRADIOL~TABLET;ORAL~ESTRADIOL~LANNETT HOLDINGS INC~2MG~A~040138~003~~Jan 30, 1
ESTRADIOL~TABLET;ORAL~ESTRADIOL~MYLAN~0.5MG~A~040326~001~AB~Apr 21, 1999~No~RX~M
ESTRADIOL~TABLET;ORAL~ESTRADIOL~MYLAN~1MG~A~040326~002~AB~Apr 21, 1999~No~RX~MYL
ESTRADIOL~TABLET;ORAL~ESTRADIOL~MYLAN~2MG~A~040326~003~AB~Apr 21, 1999~No~RX~MYL
ESTRADIOL~TABLET;ORAL~ESTRADIOL~USL PHARMA~0.5MG~A~040297~001~AB~Apr 17, 2002~No
~RX~USL PHARMA INC
ESTRADIOL~TABLET;ORAL~ESTRADIOL~USL PHARMA~1MG~A~040297~002~AB~Apr 17, 2002~No~R
X~USL PHARMA INC
ESTRADIOL~TABLET;ORAL~ESTRADIOL~USL PHARMA~2MG~A~040297~003~AB~Apr 17, 2002~No~R
X~USL PHARMA INC
ESTRADIOL~TABLET;ORAL~ESTRADIOL~WATSON LABS~0.5MG~A~040114~003~AB~Mar 14, 1996~N
ESTRADIOL~TABLET;ORAL~ESTRADIOL~WATSON LABS~1MG~A~040114~001~AB~Mar 14, 1996~No~
ESTRADIOL~TABLET;ORAL~ESTRADIOL~WATSON LABS~2MG~A~040114~002~AB~Mar 14, 1996~No~
ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~ESTRADIOL AND NORETHINDRONE ACETATE
~BARR~1MG;0.5MG~A~079193~001~AB~May 11, 2010~No~RX~BARR LABORATORIES INC
~BRECKENRIDGE PHARM~0.5MG;0.1MG~A~078324~002~AB~Jun 9, 2011~No~RX~BRECKENRIDGE P
HARMACEUTICAL INC
~BRECKENRIDGE PHARM~1MG;0.5MG~A~078324~001~AB~Apr 17, 2008~No~RX~BRECKENRIDGE PH

ARMACEUTICAL INC
~TEVA PHARMS USA~0.5MG;0.1MG~A~200747~001~AB~Mar 8, 2012~No~RX~TEVA PHARMACEUTIC
ALS USA INC
ESTRADIOL; NORGESTIMATE~TABLET;ORAL~ESTRADIOL AND NORGESTIMATE~BARR~1MG,1MG;N/A,
0.09MG~A~076812~001~~Apr 29, 2005~Yes~RX~BARR LABORATORIES INC
ESTROGENS, ESTERIFIED~TABLET;ORAL~ESTRATAB~SOLVAY~0.3MG~A~086715~001~~Approved P
rior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
ESTROGENS, ESTERIFIED~TABLET;ORAL~ESTRATAB~SOLVAY~0.625MG~A~083209~001~~Approved
ESTROGENS, ESTERIFIED~TABLET;ORAL~ESTRATAB~SOLVAY~1.25MG~A~083856~001~~Approved
ESTROGENS, ESTERIFIED~TABLET;ORAL~ESTRATAB~SOLVAY~2.5MG~A~083857~001~~Approved P
rior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~BARR~0.75MG~A~040135~001~AB~Nov 27, 1996~No~
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~BARR~1.5MG~A~040135~002~AB~Nov 27, 1996~No~R
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~BARR~3MG~A~040135~003~AB~Nov 27, 1996~No~RX~
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~DURAMED PHARMS BARR~0.75MG~A~040296~001~~Nov
1, 1999~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~DURAMED PHARMS BARR~1.5MG~A~040296~002~~Nov
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~DURAMED PHARMS BARR~3MG~A~040296~003~~Nov 1,
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~MYLAN~0.75MG~A~040359~001~AB~Aug 26, 1999~No
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~MYLAN~1.5MG~A~040359~002~AB~Aug 26, 1999~No~
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~MYLAN~3MG~A~040359~003~~Aug 26, 1999~No~DISC
N~MYLAN PHARMACEUTICALS INC
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~WATSON LABS~0.75MG~A~081213~001~AB~Sep 23, 1
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~WATSON LABS~1.5MG~A~081214~001~AB~Sep 23, 19
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~WATSON LABS~3MG~A~081215~001~AB~Sep 23, 1993
ESTROPIPATE~TABLET;ORAL~ESTROPIPATE~WATSON LABS~6MG~A~081216~001~~Sep 23, 1993~N
QUINESTROL~TABLET;ORAL~ESTROVIS~PARKE DAVIS~0.1MG~N~016768~002~~Approved Prior t
QUINESTROL~TABLET;ORAL~ESTROVIS~PARKE DAVIS~0.2MG~N~016768~003~~Approved Prior t
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~DR REDDYS LABS LTD~1MG~A~091024~001~AB~Apr 1
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~GLENMARK GENERICS~1MG~A~091166~001~AB~Apr 15
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~LUPIN LTD~1MG~A~091124~001~AB~Sep 13, 2011~N
o~RX~LUPIN LTD
o~RX~LUPIN LTD
o~RX~LUPIN LTD
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~MACLEODS PHARMS LTD~1MG~A~202929~001~AB~Jan
30, 2015~No~RX~MACLEODS PHARMACEUTICALS LTD
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~MYLAN PHARMS INC~1MG~A~091151~001~AB~Mar 26,
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~ORCHID HLTHCARE~1MG~A~091113~001~AB~Jun 10,
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~ROXANE~1MG~A~091153~001~AB~Apr 15, 2014~No~R
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~SUN PHARMA GLOBAL~1MG~A~091103~001~AB~Apr 3,
2013~No~RX~SUN PHARMA GLOBAL FZE
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~TEVA~1MG~A~091169~001~AB~May 23, 2011~No~RX~
ESZOPICLONE~TABLET;ORAL~ESZOPICLONE~WOCKHARDT LTD~1MG~A~091165~001~~Jul 14, 2011
~No~DISCN~WOCKHARDT LTD
ETHAMBUTOL HYDROCHLORIDE~TABLET;ORAL~ETHAMBUTOL HYDROCHLORIDE~BARR~400MG~A~07605
7~001~AB~Nov 26, 2001~No~RX~BARR LABORATORIES INC
ETHAMBUTOL HYDROCHLORIDE~TABLET;ORAL~ETHAMBUTOL HYDROCHLORIDE~LUPIN~100MG~A~0789
39~001~AB~Jun 17, 2009~No~RX~LUPIN LTD
ETHAMBUTOL HYDROCHLORIDE~TABLET;ORAL~ETHAMBUTOL HYDROCHLORIDE~LUPIN~400MG~A~0789
ETHAMBUTOL HYDROCHLORIDE~TABLET;ORAL~ETHAMBUTOL HYDROCHLORIDE~VERSAPHARM INC~100
MG~A~075095~001~AB~Nov 30, 1999~No~RX~VERSAPHARM INC
ETHAMBUTOL HYDROCHLORIDE~TABLET;ORAL~ETHAMBUTOL HYDROCHLORIDE~VERSAPHARM INC~400
MG~A~075095~002~AB~Nov 30, 1999~No~RX~VERSAPHARM INC
ETHOXZOLAMIDE~TABLET;ORAL~ETHAMIDE~ALLERGAN~125MG~N~016144~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~ALLERGAN PHARMACEUTICAL
MORICIZINE HYDROCHLORIDE~TABLET;ORAL~ETHMOZINE~SHIRE~200MG~N~019753~001~~Jun 19,

ERYTHROMYCIN STEARATE~TABLET;ORAL~ETHRIL 250~BRISTOL MYERS SQUIBB~EQ 250MG BASE~
A~061605~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
ERYTHROMYCIN STEARATE~TABLET;ORAL~ETHRIL 500~BRISTOL MYERS SQUIBB~EQ 500MG BASE~
A~061605~002~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
ETIDRONATE DISODIUM~TABLET;ORAL~ETIDRONATE DISODIUM~MYLAN~200MG~A~075800~001~AB~
ETIDRONATE DISODIUM~TABLET;ORAL~ETIDRONATE DISODIUM~MYLAN~400MG~A~075800~002~AB~
ETODOLAC~TABLET;ORAL~ETODOLAC~AAIPHARMA LLC~400MG~A~074927~001~~Oct 30, 1997~No~
DISCN~AAIPHARMA LLC
ETODOLAC~TABLET;ORAL~ETODOLAC~APOTEX INC~400MG~A~076004~001~AB~Dec 3, 2002~No~RX
~APOTEX INC ETOBICOKE SITE
ETODOLAC~TABLET;ORAL~ETODOLAC~APOTEX INC~500MG~A~076004~002~AB~Dec 3, 2002~No~RX
~APOTEX INC ETOBICOKE SITE
ETODOLAC~TABLET;ORAL~ETODOLAC~IVAX SUB TEVA PHARMS~400MG~A~074883~001~~Feb 28, 1
ETODOLAC~TABLET;ORAL~ETODOLAC~IVAX SUB TEVA PHARMS~500MG~A~074883~002~~Nov 20, 1
ETODOLAC~TABLET;ORAL~ETODOLAC~MYLAN~400MG~A~075012~001~~Sep 30, 1998~No~DISCN~MY
ETODOLAC~TABLET;ORAL~ETODOLAC~MYLAN~400MG~A~075104~001~AB~Feb 6, 1998~No~RX~MYLA
N LABORATORIES INC
ETODOLAC~TABLET;ORAL~ETODOLAC~MYLAN~500MG~A~075012~002~~Sep 30, 1998~No~DISCN~MY
ETODOLAC~TABLET;ORAL~ETODOLAC~MYLAN~500MG~A~075104~002~AB~Nov 20, 1998~No~RX~MYL
AN LABORATORIES INC
ETODOLAC~TABLET;ORAL~ETODOLAC~PROSAM LABS~400MG~A~074819~001~~Feb 28, 1997~No~DI
SCN~PROSAM LABS LLC
ETODOLAC~TABLET;ORAL~ETODOLAC~PROSAM LABS~500MG~A~074819~002~~Apr 28, 1998~No~DI
SCN~PROSAM LABS LLC
ETODOLAC~TABLET;ORAL~ETODOLAC~RANBAXY LABS LTD~400MG~A~075226~001~~Nov 24, 1998~
No~DISCN~RANBAXY LABORATORIES LTD
ETODOLAC~TABLET;ORAL~ETODOLAC~RANBAXY LABS LTD~500MG~A~075226~002~~Nov 24, 1998~
No~DISCN~RANBAXY LABORATORIES LTD
ETODOLAC~TABLET;ORAL~ETODOLAC~SANDOZ~400MG~A~074839~001~~Jul 11, 1997~No~DISCN~S
ANDOZ INC
ETODOLAC~TABLET;ORAL~ETODOLAC~SANDOZ~400MG~A~074846~001~~Feb 28, 1997~No~DISCN~S
ANDOZ INC
ETODOLAC~TABLET;ORAL~ETODOLAC~SANDOZ~400MG~A~074903~001~AB~Apr 11, 1997~No~RX~SA
NDOZ INC
ETODOLAC~TABLET;ORAL~ETODOLAC~SANDOZ~500MG~A~074903~002~AB~Apr 19, 1999~No~RX~SA
NDOZ INC
ETODOLAC~TABLET;ORAL~ETODOLAC~TARO PHARM INDS~400MG~A~075074~001~AB~Mar 11, 1998
~No~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
ETODOLAC~TABLET;ORAL~ETODOLAC~TARO PHARM INDS~500MG~A~075074~002~AB~Apr 25, 2000
~Yes~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
ETODOLAC~TABLET;ORAL~ETODOLAC~TEVA~400MG~A~074847~001~~Apr 23, 1999~No~DISCN~TEV
ETODOLAC~TABLET;ORAL~ETODOLAC~TEVA~400MG~A~075009~001~AB~Nov 26, 1997~No~RX~TEVA
ETODOLAC~TABLET;ORAL~ETODOLAC~TEVA~500MG~A~074847~002~~Apr 23, 1999~No~DISCN~TEV
ETODOLAC~TABLET;ORAL~ETODOLAC~TEVA~500MG~A~075009~002~AB~Dec 28, 1999~No~RX~TEVA
ETODOLAC~TABLET;ORAL~ETODOLAC~VINTAGE PHARMS LLC~400MG~A~074841~001~~Jun 27, 199
ETODOLAC~TABLET;ORAL~ETODOLAC~WATSON LABS~400MG~A~074892~001~~Apr 16, 1997~No~DI

ETODOLAC~TABLET;ORAL~ETODOLAC~WATSON LABS~400MG~A~075069~001~~Apr 16, 1998~No~DI
ETODOLAC~TABLET;ORAL~ETODOLAC~WATSON LABS~500MG~A~074892~002~~Oct 29, 1998~No~DI
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE~TABLET;ORAL~ETRAFON 2-10~SCHERING~10MG
;2MG~N~014713~007~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHE
RING PLOUGH CORP
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE~TABLET;ORAL~ETRAFON 2-25~SCHERING~25MG
;2MG~N~014713~004~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHE
RING PLOUGH CORP
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE~TABLET;ORAL~ETRAFON-A~SCHERING~10MG;4M
G~N~014713~002~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERIN
G PLOUGH CORP
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE~TABLET;ORAL~ETRAFON-FORTE~SCHERING~25M
G;4MG~N~014713~006~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCH
ERING PLOUGH CORP
LIOTRIX (T4;T3)~TABLET;ORAL~EUTHROID-0.5~PARKE DAVIS~0.03MG;0.0075MG~N~016680~00
LIOTRIX (T4;T3)~TABLET;ORAL~EUTHROID-1~PARKE DAVIS~0.06MG;0.015MG~N~016680~002~~
LIOTRIX (T4;T3)~TABLET;ORAL~EUTHROID-2~PARKE DAVIS~0.12MG;0.03MG~N~016680~003~~A
LIOTRIX (T4;T3)~TABLET;ORAL~EUTHROID-3~PARKE DAVIS~0.18MG;0.045MG~N~016680~004~~
PARGYLINE HYDROCHLORIDE~TABLET;ORAL~EUTONYL~ABBOTT~10MG~N~013448~002~~Approved P
rior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
METHYCLOTHIAZIDE; PARGYLINE HYDROCHLORIDE~TABLET;ORAL~EUTRON~ABBOTT~5MG;25MG~N~0
16047~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUT
ICAL PRODUCTS DIV
ESTROGENS, ESTERIFIED~TABLET;ORAL~EVEX~ROCHE PALO~0.625MG~A~084215~001~~Approved
Prior to Jan 1, 1982~No~DISCN~ROCHE PALO ALTO LLC
ESTROGENS, ESTERIFIED~TABLET;ORAL~EVEX~ROCHE PALO~1.25MG~A~083376~002~~Approved
Prior to Jan 1, 1982~No~DISCN~ROCHE PALO ALTO LLC
RALOXIFENE HYDROCHLORIDE~TABLET;ORAL~EVISTA~LILLY~60MG~N~020815~001~AB~Dec 9, 19
97~Yes~RX~ELI LILLY AND CO
ATAZANAVIR SULFATE; COBICISTAT~TABLET;ORAL~EVOTAZ~BRISTOL MYERS SQUIBB~EQ 300MG
BASE;150MG~N~206353~001~~Jan 29, 2015~Yes~RX~BRISTOL MYERS SQUIBB
ACETAMINOPHEN; ASPIRIN; CAFFEINE~TABLET;ORAL~EXCEDRIN (MIGRAINE)~NOVARTIS~250MG;
250MG;65MG~N~020802~001~~Jan 14, 1998~Yes~OTC~NOVARTIS CONSUMER HEALTH INC
EXEMESTANE~TABLET;ORAL~EXEMESTANE~ALVOGEN INC~25MG~A~200898~001~AB~Jul 28, 2014~
No~RX~ALVOGEN INC
EXEMESTANE~TABLET;ORAL~EXEMESTANE~ROXANE~25MG~A~077431~001~AB~Apr 1, 2011~No~RX~
AMLODIPINE BESYLATE; VALSARTAN~TABLET;ORAL~EXFORGE~NOVARTIS~EQ 5MG BASE;160MG~N~
021990~002~AB~Jun 20, 2007~No~RX~NOVARTIS PHARMACEUTICALS CORP
AMLODIPINE BESYLATE; VALSARTAN~TABLET;ORAL~EXFORGE~NOVARTIS~EQ 5MG BASE;320MG~N~
021990~004~AB~Jun 20, 2007~No~RX~NOVARTIS PHARMACEUTICALS CORP
AMLODIPINE BESYLATE; VALSARTAN~TABLET;ORAL~EXFORGE~NOVARTIS~EQ 10MG BASE;160MG~N
~021990~003~AB~Jun 20, 2007~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
AMLODIPINE BESYLATE; VALSARTAN~TABLET;ORAL~EXFORGE~NOVARTIS~EQ 10MG BASE;320MG~N
~021990~005~AB~Jun 20, 2007~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~EXFORGE HCT~NOVA
RTIS~5MG;12.5MG;160MG~N~022314~001~AB~Apr 30, 2009~No~RX~NOVARTIS PHARMACEUTICAL
S CORP
RTIS~5MG;25MG;160MG~N~022314~002~AB~Apr 30, 2009~No~RX~NOVARTIS PHARMACEUTICALS

CORP
RTIS~10MG;12.5MG;160MG~N~022314~003~AB~Apr 30, 2009~No~RX~NOVARTIS PHARMACEUTICA
LS CORP
RTIS~10MG;25MG;160MG~N~022314~004~AB~Apr 30, 2009~No~RX~NOVARTIS PHARMACEUTICALS
CORP
RTIS~10MG;25MG;320MG~N~022314~005~AB~Apr 30, 2009~Yes~RX~NOVARTIS PHARMACEUTICAL
S CORP
BENZTHIAZIDE~TABLET;ORAL~EXNA~AH ROBINS INC~50MG~N~012489~001~~Approved Prior to
Jan 1, 1982~No~DISCN~AH ROBINS INC
GEMIFLOXACIN MESYLATE~TABLET;ORAL~FACTIVE~LG LIFE SCIENCES~EQ 320MG BASE~N~02115
8~001~~Apr 4, 2003~Yes~RX~LG LIFE SCIENCES LTD
LEVONORGESTREL~TABLET;ORAL~FALLBACK SOLO~LUPIN LTD~1.5MG~A~201446~001~~Jun 19, 2
014~No~OTC~LUPIN LTD
FAMCICLOVIR~TABLET;ORAL~FAMCICLOVIR~APOTEX~125MG~A~091480~001~AB~Jul 22, 2011~No
~RX~APOTEX INC
~RX~APOTEX INC
~RX~APOTEX INC
FAMCICLOVIR~TABLET;ORAL~FAMCICLOVIR~AUROBINDO PHARMA LTD~125MG~A~091114~001~AB~M
ar 21, 2011~No~RX~AUROBINDO PHARMA LTD
FAMCICLOVIR~TABLET;ORAL~FAMCICLOVIR~CIPLA LTD~125MG~A~078278~001~AB~Mar 21, 2011
~No~RX~CIPLA LTD
~No~RX~CIPLA LTD
~No~RX~CIPLA LTD
FAMCICLOVIR~TABLET;ORAL~FAMCICLOVIR~HETERO LABS LTD V~125MG~A~202438~001~AB~Sep
10, 2014~No~RX~HETERO LABS LTD UNIT V
FAMCICLOVIR~TABLET;ORAL~FAMCICLOVIR~MACLEODS PHARMS LTD~125MG~A~201022~001~AB~Ja
n 12, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
FAMCICLOVIR~TABLET;ORAL~FAMCICLOVIR~MYLAN~125MG~A~201333~001~AB~Mar 24, 2011~No~
FAMCICLOVIR~TABLET;ORAL~FAMCICLOVIR~ROXANE~125MG~A~090128~001~AB~Mar 21, 2011~No
FAMCICLOVIR~TABLET;ORAL~FAMCICLOVIR~TEVA PHARMS~125MG~A~077487~001~AB~Aug 24, 20

FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~ACTAVIS ELIZABETH~20MG~A~075650~001~~Sep 14, 2
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~ACTAVIS ELIZABETH~40MG~A~075650~002~~Sep 14, 2
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~ALEMBIC PHARMS LTD~20MG~A~078916~001~AB~May 22
, 2009~No~RX~ALEMBIC PHARMACEUTICALS LTD
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~ALEMBIC PHARMS LTD~40MG~A~078916~002~AB~May 22
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~APOTEX~10MG~A~075610~001~~Mar 12, 2002~No~DISC
N~APOTEX INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~APOTEX~20MG~A~075611~001~AB~Jul 23, 2001~No~RX
~APOTEX INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~APOTEX~40MG~A~075611~002~AB~Jul 23, 2001~No~RX
~APOTEX INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~CARLSBAD~20MG~A~075805~001~AB~Apr 16, 2001~No~
RX~CARLSBAD TECHNOLOGY INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~CARLSBAD~40MG~A~075805~002~AB~Apr 16, 2001~No~
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~DR REDDYS LABS LTD~10MG~A~075758~001~~Aug 17,
2001~No~OTC~DR REDDYS LABORATORIES LTD
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~DR REDDYS LABS LTD~20MG~A~075718~001~AB~Apr 16
, 2001~No~RX~DR REDDYS LABORATORIES LTD
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~DR REDDYS LABS LTD~20MG~A~077367~001~~Sep 25,
2006~No~OTC~DR REDDYS LABORATORIES LTD
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~DR REDDYS LABS LTD~40MG~A~075718~002~AB~Apr 16
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~IVAX SUB TEVA PHARMS~10MG~A~075512~001~~Jul 26
, 2001~No~OTC~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~IVAX SUB TEVA PHARMS~20MG~A~075511~001~AB~Apr
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~IVAX SUB TEVA PHARMS~40MG~A~075511~002~AB~Apr
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~MUTUAL PHARM~20MG~A~075639~002~~Dec 12, 2001~N
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~MUTUAL PHARM~40MG~A~075639~001~~Dec 12, 2001~N
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~MYLAN~10MG~A~075674~001~~Dec 21, 2001~No~OTC~M
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~MYLAN~20MG~A~075704~001~AB~Apr 16, 2001~No~RX~
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~MYLAN~40MG~A~075704~002~AB~Apr 16, 2001~No~RX~
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~MYLAN PHARMS INC~20MG~A~075457~001~~Apr 18, 20
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~MYLAN PHARMS INC~40MG~A~075457~002~~Apr 18, 20
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~PERRIGO~10MG~A~075400~001~~Mar 18, 2005~No~OTC
~L PERRIGO CO
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~PERRIGO~20MG~A~077351~001~~Sep 25, 2006~No~OTC
~PERRIGO CO
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~PERRIGO~20MG~A~077352~002~AB~Jul 27, 2005~No~R
X~PERRIGO CO
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~PERRIGO~40MG~A~077352~001~AB~Jul 27, 2005~No~R
X~PERRIGO CO
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~RANBAXY~10MG~A~090283~001~~Nov 17, 2009~No~OTC
~RANBAXY LABORATORIES INC

FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~RANBAXY~20MG~A~090283~002~~Nov 17, 2009~No~OTC
~RANBAXY LABORATORIES INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~SANDOZ~10MG~A~076101~001~~Oct 21, 2002~No~DISC
N~SANDOZ INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~SANDOZ~20MG~A~075302~001~~Apr 16, 2001~No~DISC
N~SANDOZ INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~SANDOZ~20MG~A~075607~001~~May 10, 2001~No~DISC
N~SANDOZ INC
N~SANDOZ INC
N~SANDOZ INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~SANDOZ~40MG~A~075607~002~~May 10, 2001~No~DISC
N~SANDOZ INC
N~SANDOZ INC
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~TEVA~10MG~A~075312~001~~May 31, 2001~No~OTC~TE
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~TEVA~20MG~A~075311~001~AB~Apr 16, 2001~No~RX~T
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~TEVA~40MG~A~075311~002~AB~Apr 16, 2001~No~RX~T
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~WATSON LABS~10MG~A~075404~001~~Nov 28, 2001~No
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~WATSON LABS~20MG~A~075062~002~~Apr 16, 2001~No
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~WATSON LABS~40MG~A~075062~001~~Apr 16, 2001~No
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~WOCKHARDT~10MG~A~077146~001~~Mar 7, 2005~No~OT
C~WOCKHARDT LTD
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~WOCKHARDT~20MG~A~075786~001~AB~Apr 16, 2001~No
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~WOCKHARDT~20MG~A~090837~001~~Aug 4, 2010~No~OT
C~WOCKHARDT LTD
FAMOTIDINE~TABLET;ORAL~FAMOTIDINE~WOCKHARDT~40MG~A~075786~002~AB~Apr 16, 2001~No
FAMCICLOVIR~TABLET;ORAL~FAMVIR~NOVARTIS~125MG~N~020363~003~AB~Dec 11, 1995~No~RX
FAMCICLOVIR~TABLET;ORAL~FAMVIR~NOVARTIS~250MG~N~020363~001~AB~Apr 26, 1996~No~RX
FAMCICLOVIR~TABLET;ORAL~FAMVIR~NOVARTIS~500MG~N~020363~002~AB~Jun 29, 1994~Yes~R
ILOPERIDONE~TABLET;ORAL~FANAPT~VANDA PHARMS INC~1MG~N~022192~001~~May 6, 2009~Ye
s~RX~VANDA PHARMACEUTICALS INC
ILOPERIDONE~TABLET;ORAL~FANAPT~VANDA PHARMS INC~2MG~N~022192~002~~May 6, 2009~No
~RX~VANDA PHARMACEUTICALS INC
ILOPERIDONE~TABLET;ORAL~FANAPT~VANDA PHARMS INC~10MG~N~022192~006~~May 6, 2009~N
o~RX~VANDA PHARMACEUTICALS INC
ILOPERIDONE~TABLET;ORAL~FANAPT~VANDA PHARMS INC~12MG~N~022192~007~~May 6, 2009~N
o~RX~VANDA PHARMACEUTICALS INC
PYRIMETHAMINE; SULFADOXINE~TABLET;ORAL~FANSIDAR~ROCHE~25MG;500MG~N~018557~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
TOREMIFENE CITRATE~TABLET;ORAL~FARESTON~PROSTRAKAN INC~EQ 60MG BASE~N~020497~001
~~May 29, 1997~Yes~RX~PROSTRAKAN INC

DAPAGLIFLOZIN~TABLET;ORAL~FARXIGA~ASTRAZENECA AB~5MG~N~202293~001~~Jan 8, 2014~N
o~RX~ASTRAZENECA AB
DAPAGLIFLOZIN~TABLET;ORAL~FARXIGA~ASTRAZENECA AB~10MG~N~202293~002~~Jan 8, 2014~
Yes~RX~ASTRAZENECA AB
FELBAMATE~TABLET;ORAL~FELBAMATE~AMNEAL PHARMS~400MG~A~201680~001~AB~Sep 13, 2011
~No~RX~AMNEAL PHARMACEUTICALS
FELBAMATE~TABLET;ORAL~FELBAMATE~AMNEAL PHARMS~600MG~A~201680~002~AB~Sep 13, 2011
FELBAMATE~TABLET;ORAL~FELBATOL~MEDA PHARMS~400MG~N~020189~001~AB~Jul 29, 1993~No
~RX~MEDA PHARMACEUTICALS INC
FELBAMATE~TABLET;ORAL~FELBATOL~MEDA PHARMS~600MG~N~020189~002~AB~Jul 29, 1993~Ye
s~RX~MEDA PHARMACEUTICALS INC
LETROZOLE~TABLET;ORAL~FEMARA~NOVARTIS PHARMS~2.5MG~N~020726~001~AB~Jul 25, 1997~
Yes~RX~NOVARTIS PHARMACEUTICALS CORP
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~FEMHRT~WARNER CHILCOTT LLC~
0.0025MG;0.5MG~N~021065~001~~Jan 14, 2005~No~RX~WARNER CHILCOTT CO LLC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~FEMHRT~WARNER CHILCOTT LLC~
0.005MG;1MG~N~021065~002~~Oct 15, 1999~No~DISCN~WARNER CHILCOTT CO LLC
ETHINYL ESTRADIOL~TABLET;ORAL~FEMINONE~PHARMACIA AND UPJOHN~0.05MG~N~016649~001~
~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
ESTROGENS, ESTERIFIED~TABLET;ORAL~FEMOGEN~PVT FORM~0.625MG~A~085076~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
ESTROGENS, ESTERIFIED~TABLET;ORAL~FEMOGEN~PVT FORM~1.25MG~A~085008~001~~Approved
Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
ESTROGENS, ESTERIFIED~TABLET;ORAL~FEMOGEN~PVT FORM~2.5MG~A~085007~001~~Approved
Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
ESTRADIOL ACETATE~TABLET;ORAL~FEMTRACE~WARNER CHILCOTT LLC~0.45MG~N~021633~001~~
Aug 20, 2004~No~RX~WARNER CHILCOTT CO LLC
ESTRADIOL ACETATE~TABLET;ORAL~FEMTRACE~WARNER CHILCOTT LLC~0.9MG~N~021633~002~~A
ug 20, 2004~No~RX~WARNER CHILCOTT CO LLC
ESTRADIOL ACETATE~TABLET;ORAL~FEMTRACE~WARNER CHILCOTT LLC~1.8MG~N~021633~003~~A
ug 20, 2004~Yes~RX~WARNER CHILCOTT CO LLC
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~IMPAX LABS~54MG~A~076509~001~AB~Mar 26, 2008
~No~RX~IMPAX LABORATORIES INC
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~IMPAX LABS~160MG~A~076509~002~AB~Mar 26, 200
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~LUPIN LTD~48MG~A~090856~001~AB~Dec 23, 2011~
No~RX~LUPIN LTD
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~LUPIN LTD~145MG~A~090856~002~AB~Dec 23, 2011
~No~RX~LUPIN LTD
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~MYLAN~54MG~A~076520~001~AB~Oct 25, 2007~No~R
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~MYLAN~107MG~A~076520~002~~Dec 29, 2005~No~DI
SCN~MYLAN PHARMACEUTICALS INC
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~MYLAN~160MG~A~076520~003~AB~Oct 25, 2007~No~
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~MYLAN PHARMS INC~48MG~A~202856~001~AB~Dec 7,
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~MYLAN PHARMS INC~145MG~A~202856~002~AB~Dec 7
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~RANBAXY~54MG~A~076635~001~AB~Oct 31, 2005~No
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~RANBAXY~107MG~A~076635~002~~Oct 31, 2005~No~
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~RANBAXY~160MG~A~076635~003~AB~Oct 31, 2005~N
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~TEVA~54MG~A~076433~001~AB~May 13, 2005~No~RX
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~TEVA~160MG~A~076433~002~AB~May 13, 2005~Yes~

FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~VALEANT INTL~48MG~A~090715~001~AB~Apr 5, 201
2~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
FENOFIBRATE~TABLET;ORAL~FENOFIBRATE~VALEANT INTL~145MG~A~090715~002~AB~Apr 5, 20
FENOFIBRATE~TABLET;ORAL~FENOGLIDE~SANTARUS INC~40MG~N~022118~001~~Aug 10, 2007~N
o~RX~SANTARUS INC
FENOFIBRATE~TABLET;ORAL~FENOGLIDE~SANTARUS INC~120MG~N~022118~002~~Aug 10, 2007~
Yes~RX~SANTARUS INC
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~ACTAVIS ELIZABETH~EQ 600MG BAS
E~A~072274~001~~May 2, 1988~No~DISCN~ACTAVIS ELIZABETH LLC
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~AM THERAP~EQ 600MG BASE~A~0723
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~DAVA PHARMS INC~EQ 600MG BASE~
A~072326~001~~Aug 17, 1988~No~DISCN~DAVA PHARMACEUTICALS INC
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~HALSEY~EQ 600MG BASE~A~072357~
001~~Aug 17, 1988~No~DISCN~HALSEY DRUG CO INC
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~IVAX SUB TEVA PHARMS~EQ 600MG
BASE~A~072557~001~~Aug 29, 1988~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~MUTUAL PHARM~EQ 600MG BASE~A~0
72902~001~~Dec 21, 1990~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~MYLAN PHARMS INC~EQ 600MG BASE
~A~072267~001~~Aug 17, 1988~Yes~RX~MYLAN PHARMACEUTICALS INC
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~PAR PHARM~EQ 600MG BASE~A~0724
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~QUANTUM PHARMICS~EQ 600MG BASE
~A~072194~001~~Aug 17, 1988~No~DISCN~QUANTUM PHARMICS LTD
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~SANDOZ~EQ 600MG BASE~A~072396~
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~USL PHARMA~EQ 600MG BASE~A~072
362~001~~Aug 17, 1988~No~DISCN~USL PHARMA INC
FENOPROFEN CALCIUM~TABLET;ORAL~FENOPROFEN CALCIUM~WATSON LABS~EQ 600MG BASE~A~07
DEXTROAMPHETAMINE SULFATE~TABLET;ORAL~FERNDEX~FERNDALE LABS~5MG~A~084001~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
PREDNISOLONE~TABLET;ORAL~FERNISOLONE-P~FERNDALE LABS~5MG~A~083941~001~~Approved
Prior to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
PREDNISONE~TABLET;ORAL~FERNISONE~FERNDALE LABS~5MG~A~083364~001~~Approved Prior
to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
DEFERIPRONE~TABLET;ORAL~FERRIPROX~APOPHARMA INC~500MG~N~021825~001~~Oct 14, 2011
~Yes~RX~APOPHARMA INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE~BARR~30MG~A~07
6191~001~AB~Aug 31, 2005~No~RX~BARR LABORATORIES INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE~DR REDDYS LABS
LTD~30MG~A~076502~001~AB~Apr 11, 2006~No~RX~DR REDDYS LABORATORIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE~MYLAN~30MG~A~0
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE~MYLAN~60MG~A~0

FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE~MYLAN~180MG~A~
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE~TEVA~30MG~A~07
6447~001~AB~Sep 1, 2005~No~RX~TEVA PHARMACEUTICALS USA INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~AUROLI
FE PHARMA LLC~60MG~A~202039~002~~Nov 19, 2014~No~OTC~AUROLIFE PHARMA LLC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~AUROLI
FE PHARMA LLC~180MG~A~202039~003~~Nov 19, 2014~No~OTC~AUROLIFE PHARMA LLC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~DR RED
DYS LABS LTD~60MG~A~076502~006~~Apr 12, 2011~No~OTC~DR REDDYS LABORATORIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~DR RED
DYS LABS LTD~180MG~A~076502~008~~Apr 12, 2011~No~OTC~DR REDDYS LABORATORIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~MYLAN~
60MG~A~077081~006~~Jul 21, 2011~No~OTC~MYLAN PHARMACEUTICALS INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~MYLAN~
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~SUN PH
ARM INDS~60MG~A~091567~004~~Feb 6, 2012~No~OTC~SUN PHARMACEUTICAL INDUSTRIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~SUN PH
ARM INDS~180MG~A~091567~006~~Feb 6, 2012~No~OTC~SUN PHARMACEUTICAL INDUSTRIES LT
D
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~TEVA~6
0MG~A~076447~006~~Apr 13, 2011~No~OTC~TEVA PHARMACEUTICALS USA INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~TEVA~1
80MG~A~076447~008~~Apr 13, 2011~No~OTC~TEVA PHARMACEUTICALS USA INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~WOCKHA
RDT LTD~60MG~A~079112~004~~Feb 8, 2012~No~OTC~WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE ALLERGY~WOCKHA
RDT LTD~180MG~A~079112~006~~Feb 8, 2012~No~OTC~WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~DR REDDY
S LABS LTD~60MG~A~076502~007~~Apr 12, 2011~No~OTC~DR REDDYS LABORATORIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~DR REDDY
S LABS LTD~180MG~A~076502~009~~Apr 12, 2011~No~OTC~DR REDDYS LABORATORIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~MYLAN~60
MG~A~077081~007~~Jul 21, 2011~No~OTC~MYLAN PHARMACEUTICALS INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~MYLAN~18
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~SUN PHAR
M INDS~60MG~A~091567~003~~Feb 6, 2012~No~OTC~SUN PHARMACEUTICAL INDUSTRIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~SUN PHAR
M INDS~180MG~A~091567~005~~Feb 6, 2012~No~OTC~SUN PHARMACEUTICAL INDUSTRIES LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~TEVA~60M
G~A~076447~007~~Apr 13, 2011~No~OTC~TEVA PHARMACEUTICALS USA INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~TEVA~180
MG~A~076447~009~~Apr 13, 2011~No~OTC~TEVA PHARMACEUTICALS USA INC
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~WOCKHARD
T LTD~60MG~A~079112~003~~Feb 8, 2012~No~OTC~WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE~TABLET;ORAL~FEXOFENADINE HYDROCHLORIDE HIVES~WOCKHARD
T LTD~180MG~A~079112~005~~Feb 8, 2012~No~OTC~WOCKHARDT LTD
FENOFIBRIC ACID~TABLET;ORAL~FIBRICOR~MUTUAL PHARM CO INC~35MG~N~022418~001~~Aug
FENOFIBRIC ACID~TABLET;ORAL~FIBRICOR~MUTUAL PHARM CO INC~105MG~N~022418~002~~Aug
14, 2009~Yes~RX~MUTUAL PHARMACEUTICAL CO INC
FINASTERIDE~TABLET;ORAL~FINASTERIDE~ACCORD HLTHCARE~5MG~A~090121~001~AB~Feb 23,

FINASTERIDE~TABLET;ORAL~FINASTERIDE~ACCORD HLTHCARE INC~1MG~A~091643~001~AB~Nov
5, 2013~No~RX~ACCORD HEALTHCARE INC USA
FINASTERIDE~TABLET;ORAL~FINASTERIDE~ACTAVIS TOTOWA~1MG~A~078371~001~AB~Nov 5, 20
13~No~RX~ACTAVIS TOTOWA LLC
FINASTERIDE~TABLET;ORAL~FINASTERIDE~ACTAVIS TOTOWA~5MG~A~077914~001~AB~Mar 28, 2
FINASTERIDE~TABLET;ORAL~FINASTERIDE~AUROBINDO PHARMA~5MG~A~078341~001~AB~Oct 30,
FINASTERIDE~TABLET;ORAL~FINASTERIDE~AUROBINDO PHARMA LTD~1MG~A~203687~001~AB~Nov
FINASTERIDE~TABLET;ORAL~FINASTERIDE~CIPLA LTD~1MG~A~077335~001~AB~Nov 20, 2014~N
o~RX~CIPLA LTD
FINASTERIDE~TABLET;ORAL~FINASTERIDE~DR REDDYS LABS INC~1MG~A~076436~001~AB~Jul 2
8, 2006~No~RX~DR REDDYS LABORATORIES INC
FINASTERIDE~TABLET;ORAL~FINASTERIDE~DR REDDYS LABS LTD~5MG~A~076437~001~AB~Feb 2
FINASTERIDE~TABLET;ORAL~FINASTERIDE~GEDEON RICHTER USA~5MG~A~077251~001~AB~Dec 2
2, 2006~No~RX~GEDEON RICHTER USA INC
FINASTERIDE~TABLET;ORAL~FINASTERIDE~HETERO LABS LTD III~1MG~A~090060~001~AB~Jul
1, 2013~No~RX~HETERO LABS LTD UNIT III
FINASTERIDE~TABLET;ORAL~FINASTERIDE~HETERO LABS LTD III~5MG~A~090061~001~AB~Jun
FINASTERIDE~TABLET;ORAL~FINASTERIDE~IVAX SUB TEVA PHARMS~5MG~A~076340~001~~Jun 1
FINASTERIDE~TABLET;ORAL~FINASTERIDE~MYLAN~5MG~A~077578~001~AB~Dec 18, 2006~No~RX
FINASTERIDE~TABLET;ORAL~FINASTERIDE~MYLAN PHARMS INC~1MG~A~078161~001~AB~Nov 5,
FINASTERIDE~TABLET;ORAL~FINASTERIDE~SUN PHARMA GLOBAL~1MG~A~090508~001~AB~Jul 1,
FINASTERIDE~TABLET;ORAL~FINASTERIDE~SUN PHARMA GLOBAL~5MG~A~090507~001~AB~Aug 16
FINASTERIDE~TABLET;ORAL~FINASTERIDE~TEVA~1MG~A~076905~001~AB~Nov 5, 2013~No~RX~T
FINASTERIDE~TABLET;ORAL~FINASTERIDE~TEVA~5MG~A~076511~001~AB~Dec 15, 2006~No~RX~
FINASTERIDE~TABLET;ORAL~FINASTERIDE~ZYDUS PHARMS USA INC~5MG~A~078900~001~AB~Dec
ACETAMINOPHEN; BUTALBITAL; CAFFEINE~TABLET;ORAL~FIORICET~ACTAVIS LABS UT INC~325
MG;50MG;40MG~A~088616~001~~Nov 9, 1984~No~DISCN~ACTAVIS LABORATORIES UT INC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~FIORINAL~ACTAVIS LABS UT INC~325MG;50M
G;40MG~N~017534~003~~Apr 16, 1986~No~DISCN~ACTAVIS LABORATORIES UT INC
METRONIDAZOLE~TABLET;ORAL~FLAGYL~GD SEARLE LLC~250MG~N~012623~001~AB~Approved Pr
ior to Jan 1, 1982~No~RX~GD SEARLE LLC
METRONIDAZOLE~TABLET;ORAL~FLAGYL~GD SEARLE LLC~500MG~N~012623~003~AB~Approved Pr
ior to Jan 1, 1982~Yes~RX~GD SEARLE LLC
FLAVOXATE HYDROCHLORIDE~TABLET;ORAL~FLAVOXATE HYDROCHLORIDE~EPIC PHARMA~100MG~A~
076835~001~AB~Nov 30, 2005~No~RX~EPIC PHARMA LLC
FLAVOXATE HYDROCHLORIDE~TABLET;ORAL~FLAVOXATE HYDROCHLORIDE~IMPAX PHARMS~100MG~A
~076234~001~AB~Aug 28, 2003~No~RX~IMPAX PHARMACEUTICALS
FLAVOXATE HYDROCHLORIDE~TABLET;ORAL~FLAVOXATE HYDROCHLORIDE~PADDOCK LLC~100MG~A~
076831~001~AB~Dec 16, 2004~Yes~RX~PADDOCK LABORATORIES LLC
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~AMNEAL PHARM~50MG~A~075442~001
~AB~Jul 31, 2001~No~RX~AMNEAL PHARMACEUTICAL
2~AB~Jul 31, 2001~No~RX~AMNEAL PHARMACEUTICAL
3~AB~Jul 31, 2001~No~RX~AMNEAL PHARMACEUTICAL
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~APOTEX INC~50MG~A~079164~001~~
Jul 9, 2009~No~DISCN~APOTEX INC

FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~APOTEX INC~100MG~A~079164~002~
~Jul 9, 2009~No~DISCN~APOTEX INC
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~APOTEX INC~150MG~A~079164~003~
~Jul 9, 2009~No~DISCN~APOTEX INC
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~BARR~50MG~A~075882~001~AB~Oct
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~RANBAXY~50MG~A~076421~001~AB~M
ar 28, 2003~No~RX~RANBAXY LABORATORIES LTD
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~RANBAXY~100MG~A~076421~002~AB~
Mar 28, 2003~No~RX~RANBAXY LABORATORIES LTD
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~RANBAXY~150MG~A~076421~003~AB~
Mar 28, 2003~No~RX~RANBAXY LABORATORIES LTD
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~ROXANE~50MG~A~076278~001~AB~Ja
n 14, 2003~No~RX~ROXANE LABORATORIES INC
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~ROXANE~100MG~A~076278~002~AB~J
an 14, 2003~No~RX~ROXANE LABORATORIES INC
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~ROXANE~150MG~A~076278~003~AB~J
an 14, 2003~Yes~RX~ROXANE LABORATORIES INC
FLECAINIDE ACETATE~TABLET;ORAL~FLECAINIDE ACETATE~SANDOZ~50MG~A~076030~001~~Oct
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~FLEXERIL~JANSSEN RES AND DEV~5MG~N~017
821~001~~Approved Prior to Jan 1, 1982~No~DISCN~JANSSEN RESEARCH AND DEVELOPMENT
LLC
CYCLOBENZAPRINE HYDROCHLORIDE~TABLET;ORAL~FLEXERIL~JANSSEN RES AND DEV~10MG~N~01
7821~002~~Approved Prior to Jan 1, 1982~No~DISCN~JANSSEN RESEARCH AND DEVELOPMEN
T LLC
FLUDROCORTISONE ACETATE~TABLET;ORAL~FLORINEF~CITRON PHARMA LLC~0.1MG~N~010060~00
OFLOXACIN~TABLET;ORAL~FLOXIN~JANSSEN PHARMS~200MG~N~019735~001~~Dec 28, 1990~No~
DISCN~JANSSEN PHARMACEUTICALS INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~APOTEX~50MG~A~076665~001~AB~Jul 29, 2004~No~
RX~APOTEX INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~APOTEX~100MG~A~076665~002~AB~Jul 29, 2004~No
~RX~APOTEX INC
~RX~APOTEX INC
~RX~APOTEX INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~AUROBINDO PHARMA~50MG~A~077731~001~AB~Oct 7,
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~AUROBINDO PHARMA~100MG~A~077731~002~AB~Oct 7
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~DR REDDYS LABS INC~50MG~A~076658~001~AB~Jul

FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~GEDEON RICHTER USA~50MG~A~076432~001~~Jul 29
, 2004~No~DISCN~GEDEON RICHTER USA INC
9, 2004~No~DISCN~GEDEON RICHTER USA INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~GLENMARK GENERICS~50MG~A~077253~001~AB~Jan 2
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~GLENMARK GENERICS~100MG~A~077253~002~AB~Jan
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~HARRIS PHARM~50MG~A~078423~001~~Mar 7, 2011~
No~DISCN~HARRIS PHARMACEUTICAL INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~HARRIS PHARM~100MG~A~078423~002~~Mar 7, 2011
~No~DISCN~HARRIS PHARMACEUTICAL INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~IVAX SUB TEVA PHARMS~50MG~A~076077~001~AB~Ju
l 29, 2004~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~IVAX SUB TEVA PHARMS~100MG~A~076077~002~AB~J
ul 29, 2004~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~MYLAN~50MG~A~076351~001~AB~Jul 29, 2004~No~R
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~MYLAN~100MG~A~076351~002~AB~Jul 29, 2004~No~
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~MYLAN PHARMS INC~50MG~A~076042~001~~Jul 29,
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~PLIVA~50MG~A~076424~001~~Jul 29, 2004~No~DIS
CN~PLIVA INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~PLIVA~100MG~A~076424~002~~Jul 29, 2004~No~DI
SCN~PLIVA INC
SCN~PLIVA INC
SCN~PLIVA INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~RANBAXY LABS LTD~50MG~A~076386~001~~Jul 29,
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~ROXANE~50MG~A~076213~001~~Jul 29, 2004~No~DI
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~ROXANE~100MG~A~076213~002~~Jul 29, 2004~No~D
ISCN~ROXANE LABORATORIES INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~SANDOZ~50MG~A~076086~001~~Jul 29, 2004~No~DI
SCN~SANDOZ INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~SANDOZ~100MG~A~076086~002~~Jul 29, 2004~No~D
ISCN~SANDOZ INC
ISCN~SANDOZ INC
ISCN~SANDOZ INC
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~TARO~50MG~A~076507~001~AB~Jul 29, 2004~No~RX
~TARO PHARMACEUTICAL INDUSTRIES LTD
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~TARO~100MG~A~076507~002~AB~Jul 29, 2004~No~R
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~TEVA~50MG~A~074681~001~AB~Jul 29, 2004~No~RX
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~TEVA~100MG~A~074681~002~AB~Jul 29, 2004~No~R
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~UNIQUE PHARM LABS~50MG~A~076957~001~AB~Sep 2
8, 2005~No~RX~UNIQUE PHARMACEUTICAL LABORATORIES
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~UNIQUE PHARM LABS~100MG~A~076957~002~AB~Sep
FLUCONAZOLE~TABLET;ORAL~FLUCONAZOLE~UNIQUE PHARM LABS~200MG~A~076957~003~AB~Sep
FLUDROCORTISONE ACETATE~TABLET;ORAL~FLUDROCORTISONE ACETATE~BARR~0.1MG~A~040425~
001~AB~Jan 21, 2003~No~RX~BARR LABORATORIES INC
FLUDROCORTISONE ACETATE~TABLET;ORAL~FLUDROCORTISONE ACETATE~HIKMA PHARMS~0.1MG~A
~091302~001~AB~Jul 22, 2011~No~RX~HIKMA PHARMACEUTICALS
FLUDROCORTISONE ACETATE~TABLET;ORAL~FLUDROCORTISONE ACETATE~IMPAX LABS~0.1MG~A~0
40431~001~AB~Mar 18, 2002~Yes~RX~IMPAX LABORATORIES INC
CYCLOTHIAZIDE~TABLET;ORAL~FLUIDIL~PHARMACIA AND UPJOHN~2MG~N~018173~001~~Approve
RIMANTADINE HYDROCHLORIDE~TABLET;ORAL~FLUMADINE~CARACO~100MG~N~019649~001~AB~Sep
17, 1993~Yes~RX~CARACO PHARMACEUTICAL LABORATORIES LTD
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~BARR~EQ 10MG BASE~
A~075810~001~~Feb 1, 2002~No~DISCN~BARR LABORATORIES INC

FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~DR REDDYS LABS INC
~EQ 10MG BASE~A~076006~001~AB~Jan 30, 2002~No~RX~DR REDDYS LABORATORIES INC
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~EDGEMONT PHARMS LL
C~EQ 60MG BASE~N~202133~001~~Oct 6, 2011~No~RX~EDGEMONT PHARMACEUTICALS LLC
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~EQ 10MG BASE~A~075865~001~~Feb 28, 2002~No~DISCN~IVAX PHARMACEUTICALS INC SUB
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~EQ 40MG BASE~A~075865~003~~Aug 30, 2004~No~DISCN~IVAX PHARMACEUTICALS INC SUB
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~MYLAN~EQ 10MG BASE
~A~075755~001~AB~Aug 2, 2001~No~RX~MYLAN PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~MYLAN~EQ 20MG BASE
~A~075755~002~~Aug 2, 2001~Yes~RX~MYLAN PHARMACEUTICALS INC
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~SANDOZ~EQ 10MG BAS
E~A~076024~001~~Jan 29, 2002~No~DISCN~SANDOZ INC
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~FLUOXETINE HYDROCHLORIDE~TEVA~EQ 10MG BASE~
A~075872~001~AB~Jan 29, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
FLUOXYMESTERONE~TABLET;ORAL~FLUOXYMESTERONE~USL PHARMA~10MG~A~088342~001~~Oct 21
, 1983~Yes~RX~USL PHARMA INC
FLUOXYMESTERONE~TABLET;ORAL~FLUOXYMESTERONE~VALEANT PHARM INTL~10MG~A~088221~001
~~May 5, 1983~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
FLUOXYMESTERONE~TABLET;ORAL~FLUOXYMESTERONE~WATSON LABS~2MG~A~088260~001~~Dec 6,
FLUOXYMESTERONE~TABLET;ORAL~FLUOXYMESTERONE~WATSON LABS~5MG~A~088265~001~~Dec 6,
FLUOXYMESTERONE~TABLET;ORAL~FLUOXYMESTERONE~WATSON LABS~10MG~A~088309~001~~Dec 6
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~LANNETT~1MG~A~
089740~001~AB~Aug 25, 1988~No~RX~LANNETT HOLDINGS INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~LANNETT~2.5MG~
A~089741~001~AB~Aug 25, 1988~No~RX~LANNETT HOLDINGS INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~LANNETT~5MG~A~
089742~001~AB~Aug 25, 1988~No~RX~LANNETT HOLDINGS INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~LANNETT~10MG~A
~089743~001~AB~Aug 25, 1988~No~RX~LANNETT HOLDINGS INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~MYLAN~1MG~A~08
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~MYLAN~2.5MG~A~
89804~001~AB~Aug 12, 1988~Yes~RX~MYLAN PHARMACEUTICALS INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~SANDOZ~1MG~A~0
89583~001~AB~Oct 16, 1987~No~RX~SANDOZ INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~SANDOZ~2.5MG~A
~089584~001~AB~Oct 16, 1987~No~RX~SANDOZ INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~SANDOZ~5MG~A~0
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~SANDOZ~10MG~A~
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~WATSON LABS~1M
G~A~088555~001~~Dec 18, 1987~No~DISCN~WATSON LABORATORIES INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~WATSON LABS~2.
5MG~A~088544~001~~Dec 18, 1987~No~DISCN~WATSON LABORATORIES INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~WATSON LABS~5M
G~A~088527~001~~Dec 18, 1987~No~DISCN~WATSON LABORATORIES INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~FLUPHENAZINE HYDROCHLORIDE~WATSON LABS~10
MG~A~088550~001~~Dec 18, 1987~No~DISCN~WATSON LABORATORIES INC

FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~IVAX SUB TEVA PHARMS~50MG~A~074411~001~~Ma
y 31, 1995~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~IVAX SUB TEVA PHARMS~100MG~A~074411~002~~M
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~MYLAN~50MG~A~074358~001~AB~Jun 20, 1994~No
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~MYLAN~100MG~A~074358~002~AB~Jun 20, 1994~N
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~PLIVA~50MG~A~074647~001~~Apr 1, 1997~No~DI
SCN~PLIVA INC
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~PLIVA~100MG~A~074647~002~~Apr 1, 1997~No~D
ISCN~PLIVA INC
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~SANDOZ~50MG~A~074448~001~~Jul 28, 1995~No~
DISCN~SANDOZ INC
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~SANDOZ~100MG~A~074448~002~~Jul 28, 1995~No
~DISCN~SANDOZ INC
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~SUN PHARM INDS INC~50MG~A~075058~001~AB~Ap
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~SUN PHARM INDS INC~100MG~A~075058~002~AB~A
pr 27, 2001~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~TEVA~50MG~A~074405~002~~May 24, 1995~No~DI
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~TEVA~100MG~A~074405~001~~May 24, 1995~No~D
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~TEVA~100MG~A~074431~001~AB~May 31, 1995~No
FLURBIPROFEN~TABLET;ORAL~FLURBIPROFEN~THERAGEN~100MG~A~074560~002~~May 16, 1997~
No~DISCN~THERAGEN INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~ACTAVIS ELIZABETH~25MG~A~075
901~001~~Dec 28, 2000~No~DISCN~ACTAVIS ELIZABETH LLC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~APOTEX~25MG~A~075902~001~AB~
May 7, 2001~No~RX~APOTEX INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~APOTEX~50MG~A~075902~002~AB~
May 7, 2001~No~RX~APOTEX INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~APOTEX~100MG~A~075902~003~AB
~May 7, 2001~No~RX~APOTEX INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~BARR~25MG~A~075897~001~AB~Ja
n 25, 2001~No~RX~BARR LABORATORIES INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~BARR~50MG~A~075897~002~AB~Ja
n 25, 2001~No~RX~BARR LABORATORIES INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~BARR~100MG~A~075897~003~AB~J
an 25, 2001~No~RX~BARR LABORATORIES INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~IVAX SUB TEVA PHARMS~25MG~A~
075898~001~~Mar 12, 2001~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTIC
ALS USA
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~IVAX SUB TEVA PHARMS~50MG~A~
075898~002~~Mar 12, 2001~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTIC
ALS USA
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~IVAX SUB TEVA PHARMS~100MG~A
~075898~003~~Mar 12, 2001~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTI
CALS USA
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~MUTUAL PHARM~25MG~A~076125~0
01~~Apr 29, 2002~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~MUTUAL PHARM~50MG~A~076125~0
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~MUTUAL PHARM~100MG~A~076125~

FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~MYLAN~25MG~A~075889~001~AB~N
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~MYLAN~50MG~A~075889~002~AB~N
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~MYLAN~50MG~A~075950~001~~Oct
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~MYLAN~100MG~A~075889~003~AB~
Nov 29, 2000~No~RX~MYLAN PHARMACEUTICALS INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~MYLAN~100MG~A~075950~002~~Oc
t 15, 2001~No~DISCN~MYLAN PHARMACEUTICALS INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~SANDOZ~25MG~A~075887~001~~Ja
n 5, 2001~No~DISCN~SANDOZ INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~SANDOZ~25MG~A~075888~001~AB~
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~SANDOZ~50MG~A~075887~002~~Ja
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~SANDOZ~50MG~A~075888~002~AB~
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~SANDOZ~100MG~A~075887~003~~J
an 5, 2001~No~DISCN~SANDOZ INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~SANDOZ~100MG~A~075888~003~AB
~Nov 29, 2000~Yes~RX~SANDOZ INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~SUN PHARM INDS INC~25MG~A~07
5900~001~~Feb 23, 2006~No~DISCN~SUN PHARMACEUTICAL INDUSTRIES INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~SYNTHON PHARMS~25MG~A~075899
~001~~Jan 17, 2001~No~DISCN~SYNTHON PHARMACEUTICALS LTD
~002~~Jan 17, 2001~No~DISCN~SYNTHON PHARMACEUTICALS LTD
9~003~~Jan 17, 2001~No~DISCN~SYNTHON PHARMACEUTICALS LTD
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~TEVA~25MG~A~075893~001~AB~Se
p 10, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~TEVA~50MG~A~075893~002~AB~Se
p 10, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~TEVA~100MG~A~075893~003~AB~S
ep 10, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
FLUVOXAMINE MALEATE~TABLET;ORAL~FLUVOXAMINE MALEATE~WATSON LABS~25MG~A~075894~00
1~~Apr 18, 2001~No~DISCN~WATSON LABORATORIES INC
DEXMETHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~FOCALIN~NOVARTIS~2.5MG~N~021278~001
~AB~Nov 13, 2001~No~RX~NOVARTIS PHARMACEUTICALS CORP
DEXMETHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~FOCALIN~NOVARTIS~5MG~N~021278~002~A
B~Nov 13, 2001~No~RX~NOVARTIS PHARMACEUTICALS CORP
DEXMETHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~FOCALIN~NOVARTIS~10MG~N~021278~003~
AB~Nov 13, 2001~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
FOLIC ACID~TABLET;ORAL~FOLIC ACID~AMNEAL PHARM~1MG~A~040625~001~AA~Jul 21, 2005~
Yes~RX~AMNEAL PHARMACEUTICAL
FOLIC ACID~TABLET;ORAL~FOLIC ACID~BARR~1MG~A~089177~001~~Jan 8, 1986~No~DISCN~BA
RR LABORATORIES INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~BICON PHARM~1MG~A~091145~001~AA~Jul 12, 2013~N
o~RX~BICON PHARMACEUTICAL INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~CADILA PHARMS LTD~1 MG~A~202437~001~AA~Jan 27,

FOLIC ACID~TABLET;ORAL~FOLIC ACID~CONTRACT PHARMACAL~1MG~A~085061~001~AA~Approve
d Prior to Jan 1, 1982~No~RX~CONTRACT PHARMACAL CORP
FOLIC ACID~TABLET;ORAL~FOLIC ACID~EVERYLIFE~1MG~A~080755~001~~Approved Prior to
Jan 1, 1982~No~DISCN~EVERYLIFE
FOLIC ACID~TABLET;ORAL~FOLIC ACID~EXCELLIUM~1MG~A~040796~001~AA~Jan 12, 2009~No~
RX~EXCELLIUM PHARMACEUTICAL INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~HALSEY~1MG~A~083598~001~~Approved Prior to Jan
1, 1982~No~DISCN~HALSEY DRUG CO INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~HIKMA PHARMS LLC~1MG~A~080600~001~AA~Approved
Prior to Jan 1, 1982~No~RX~HIKMA PHARMACEUTICALS LLC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~IMPAX LABS~1MG~A~080686~001~~Approved Prior to
Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~INVAGEN PHARMS~1MG~A~090035~001~AA~Jun 9, 2009
FOLIC ACID~TABLET;ORAL~FOLIC ACID~IVAX SUB TEVA PHARMS~1MG~A~083000~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICAL
S USA
FOLIC ACID~TABLET;ORAL~FOLIC ACID~JUBILANT CADISTA~1MG~A~040514~001~~Jun 14, 200
5~No~DISCN~JUBILANT CADISTA PHARMACEUTICALS INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~LANNETT~1MG~A~080816~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~LANNETT CO INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~LILLY~1MG~N~006135~003~~Approved Prior to Jan
FOLIC ACID~TABLET;ORAL~FOLIC ACID~MK LABS~1MG~A~083526~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~MK LABORATORIES INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~MUTUAL PHARM~1MG~A~040582~001~~Jul 18, 2005~No
~DISCN~MUTUAL PHARMACEUTICAL COMPANY, INC.
FOLIC ACID~TABLET;ORAL~FOLIC ACID~NEXGEN PHARMA INC~1MG~A~084915~001~~Approved P
rior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~PHARMERAL~1MG~A~084158~001~~Approved Prior to
Jan 1, 1982~No~DISCN~PHARMERAL INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~PIONEER PHARMS~1MG~A~088949~001~~Sep 13, 1985~
No~DISCN~PIONEER PHARMACEUTICALS INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~PUREPAC PHARM~1MG~A~080784~001~~Approved Prior
to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
FOLIC ACID~TABLET;ORAL~FOLIC ACID~SANDOZ~1MG~A~084472~001~~Approved Prior to Jan
FOLIC ACID~TABLET;ORAL~FOLIC ACID~TABLICAPS~1MG~A~083133~002~~Approved Prior to
Jan 1, 1982~No~DISCN~TABLICAPS INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~UDL~1MG~A~088199~001~~Mar 29, 1983~No~DISCN~UD
L LABORATORIES INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~USL PHARMA~1MG~A~087828~001~~May 13, 1982~No~D
ISCN~USL PHARMA INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~VALEANT PHARM INTL~1MG~A~080903~001~~Approved
FOLIC ACID~TABLET;ORAL~FOLIC ACID~VANGARD~1MG~A~088730~001~~Mar 23, 1984~No~DISC
N~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
FOLIC ACID~TABLET;ORAL~FOLIC ACID~VINTAGE~1MG~A~040756~001~AA~Jun 4, 2010~No~RX~
VINTAGE PHARMACEUTICALS LLC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~VINTAGE PHARMS~1MG~A~086296~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~VINTAGE PHARMACEUTICALS INC
FOLIC ACID~TABLET;ORAL~FOLIC ACID~WATSON LABS~1MG~A~080680~001~AA~Approved Prior
to Jan 1, 1982~Yes~RX~WATSON LABORATORIES
FOLIC ACID~TABLET;ORAL~FOLIC ACID~WATSON LABS~1MG~A~083141~001~~Approved Prior t
FOLIC ACID~TABLET;ORAL~FOLIC ACID~WATSON LABS~1MG~A~085141~002~~Approved Prior t
FOLIC ACID~TABLET;ORAL~FOLIC ACID~WHITEWORTH TOWN PLSN~1MG~A~080691~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC

FOLIC ACID~TABLET;ORAL~FOLICET~MISSION PHARMA~1MG~A~087438~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~MISSION PHARMACAL CO
FOLIC ACID~TABLET;ORAL~FOLVITE~HIKMA (MAPLE)~1MG~N~005897~004~~Approved Prior to
Jan 1, 1982~No~DISCN~HIKMA (MAPLE) LTD
METHOCARBAMOL~TABLET;ORAL~FORBAXIN~FOREST LABS~750MG~A~085136~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~FOREST LABORATORIES INC
ALENDRONATE SODIUM~TABLET;ORAL~FOSAMAX~MERCK AND CO INC~EQ 5MG BASE **Federal Re
r efficacy reasons**~N~020560~003~~Apr 25, 1997~No~DISCN~MERCK AND CO INC
ALENDRONATE SODIUM~TABLET;ORAL~FOSAMAX~MERCK AND CO INC~EQ 10MG BASE **Federal R
or efficacy reasons**~N~020560~001~~Sep 29, 1995~No~DISCN~MERCK AND CO INC
or efficacy reasons**~N~020560~004~~Oct 20, 2000~No~DISCN~MERCK AND CO INC
or efficacy reasons**~N~020560~002~~Sep 29, 1995~No~DISCN~MERCK AND CO INC
ALENDRONATE SODIUM~TABLET;ORAL~FOSAMAX~MERCK AND CO INC~EQ 70MG BASE~N~020560~00
5~AB~Oct 20, 2000~Yes~RX~MERCK AND CO INC
ALENDRONATE SODIUM; CHOLECALCIFEROL~TABLET;ORAL~FOSAMAX PLUS D~MERCK~EQ 70MG BAS
E;2,800 IU~N~021762~001~~Apr 7, 2005~No~RX~MERCK AND CO INC
ALENDRONATE SODIUM; CHOLECALCIFEROL~TABLET;ORAL~FOSAMAX PLUS D~MERCK~EQ 70MG BAS
E;5,600 IU~N~021762~002~~Apr 26, 2007~No~RX~MERCK AND CO INC
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~ACTAVIS LABS FL INC~10MG~A~07662
0~001~AB~Oct 15, 2004~No~RX~ACTAVIS LABORATORIES FL INC
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~APOTEX INC~10MG~A~076906~001~AB~
May 17, 2005~No~RX~APOTEX INC ETOBICOKE SITE
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~AUROBINDO PHARMA LTD~10MG~A~0911
63~001~AB~Mar 30, 2011~No~RX~AUROBINDO PHARMA LIMITED
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~INVAGEN PHARMS~10MG~A~077222~001
~AB~Apr 20, 2005~No~RX~INVAGEN PHARMACEUTICALS INC
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~RANBAXY LABS LTD~10MG~A~076580~0
01~~Apr 23, 2004~No~DISCN~RANBAXY LABORATORIES LTD
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~SANDOZ~10MG~A~076188~001~~Oct 8,
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~SANDOZ~10MG~A~076483~001~AB~Apr
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~TEVA~10MG~A~076139~001~AB~Nov 25
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~WATSON LABS~10MG~A~076987~001~~D
ec 23, 2004~No~DISCN~WATSON LABORATORIES INC
FOSINOPRIL SODIUM~TABLET;ORAL~FOSINOPRIL SODIUM~WATSON LABS~10MG~A~077531~001~~A
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE~TABLET;ORAL~FOSINOPRIL SODIUM AND HYDROCH
LOROTHIAZIDE~ACTAVIS LABS FL INC~10MG;12.5MG~A~076608~001~AB~Dec 3, 2004~No~RX~A
LOROTHIAZIDE~ACTAVIS LABS FL INC~20MG;12.5MG~A~076608~002~AB~Dec 3, 2004~No~RX~A
LOROTHIAZIDE~AUROBINDO PHARMA~10MG;12.5MG~A~079245~001~AB~Jul 9, 2009~No~RX~AURO
BINDO PHARMA LTD
LOROTHIAZIDE~AUROBINDO PHARMA~20MG;12.5MG~A~079245~002~AB~Jul 9, 2009~No~RX~AURO
BINDO PHARMA LTD
LOROTHIAZIDE~EMCURE PHARMS INDIA~10MG;12.5MG~A~079025~001~AB~Sep 17, 2010~No~RX~
EMCURE PHARMACEUTICALS LTD INDIA
LOROTHIAZIDE~EMCURE PHARMS INDIA~20MG;12.5MG~A~079025~002~AB~Sep 17, 2010~Yes~RX
~EMCURE PHARMACEUTICALS LTD INDIA
LOROTHIAZIDE~INVAGEN PHARMS~10MG;12.5MG~A~090228~001~AB~Jul 9, 2009~No~RX~INVAGE
LOROTHIAZIDE~INVAGEN PHARMS~20MG;12.5MG~A~090228~002~AB~Jul 9, 2009~No~RX~INVAGE
LOROTHIAZIDE~MYLAN~10MG;12.5MG~A~077705~001~~Aug 14, 2006~No~DISCN~MYLAN PHARMAC
EUTICALS INC
LOROTHIAZIDE~MYLAN~20MG;12.5MG~A~077705~002~~Aug 14, 2006~No~DISCN~MYLAN PHARMAC
EUTICALS INC
LOROTHIAZIDE~RANBAXY~10MG;12.5MG~A~076739~001~AB~Dec 17, 2004~No~RX~RANBAXY LABO
RATORIES LTD
LOROTHIAZIDE~RANBAXY~20MG;12.5MG~A~076739~002~AB~Dec 17, 2004~No~RX~RANBAXY LABO
RATORIES LTD
LOROTHIAZIDE~SANDOZ~10MG;12.5MG~A~076961~001~AB~Sep 28, 2005~No~RX~SANDOZ INC
LOROTHIAZIDE~SANDOZ~20MG;12.5MG~A~076961~002~AB~Sep 28, 2005~No~RX~SANDOZ INC
LOROTHIAZIDE~TEVA~10MG;12.5MG~A~076945~001~~Jul 5, 2006~No~DISCN~TEVA PHARMACEUT
ICALS USA INC
LOROTHIAZIDE~TEVA~20MG;12.5MG~A~076945~002~~Jul 5, 2006~No~DISCN~TEVA PHARMACEUT
ICALS USA INC
LOROTHIAZIDE~WATSON LABS~10MG;12.5MG~A~077144~001~~Aug 16, 2005~No~DISCN~WATSON
LABORATORIES INC
LOROTHIAZIDE~WATSON LABS~20MG;12.5MG~A~077144~002~~Aug 16, 2005~No~DISCN~WATSON
LABORATORIES INC
BENZTHIAZIDE~TABLET;ORAL~FOVANE~PFIZER~50MG~N~012128~002~~Approved Prior to Jan
FROVATRIPTAN SUCCINATE~TABLET;ORAL~FROVA~ENDO PHARMS~EQ 2.5MG BASE~N~021006~001~
AB~Nov 8, 2001~Yes~RX~ENDO PHARMACEUTICALS INC
FROVATRIPTAN SUCCINATE~TABLET;ORAL~FROVATRIPTAN SUCCINATE~MYLAN PHARMS INC~EQ 2.
GRISEOFULVIN, ULTRAMICROCRYSTALLINE~TABLET;ORAL~FULVICIN P/G~ELORAC~125MG~A~0619
96~001~~Approved Prior to Jan 1, 1982~No~DISCN~ELORAC INC
GRISEOFULVIN, ULTRAMICROCRYSTALLINE~TABLET;ORAL~FULVICIN P/G~ELORAC~250MG~A~0619
96~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELORAC INC
GRISEOFULVIN, ULTRAMICROCRYSTALLINE~TABLET;ORAL~FULVICIN P/G 165~ELORAC~165MG~A~
061996~003~~Apr 6, 1982~No~DISCN~ELORAC INC
GRISEOFULVIN, ULTRAMICROCRYSTALLINE~TABLET;ORAL~FULVICIN P/G 330~ELORAC~330MG~A~
061996~004~~Apr 6, 1982~No~DISCN~ELORAC INC
GRISEOFULVIN, MICROCRYSTALLINE~TABLET;ORAL~FULVICIN-U/F~ELORAC~250MG~A~060569~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~ELORAC INC
GRISEOFULVIN, MICROCRYSTALLINE~TABLET;ORAL~FULVICIN-U/F~ELORAC~500MG~A~060569~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~ELORAC INC
NITROFURANTOIN~TABLET;ORAL~FURADANTIN~PROCTER AND GAMBLE~50MG~N~008693~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PR
OCTER AND GAMBLE CO
NITROFURANTOIN~TABLET;ORAL~FURADANTIN~PROCTER AND GAMBLE~100MG~N~008693~002~~App
roved Prior to Jan 1, 1982~No~DISCN~PROCTER AND GAMBLE PHARMACEUTICALS INC SUB P
ROCTER AND GAMBLE CO
NITROFURANTOIN~TABLET;ORAL~FURALAN~LANNETT~50MG~A~080017~001~~Approved Prior to
NITROFURANTOIN~TABLET;ORAL~FURALAN~LANNETT~100MG~A~080017~002~~Approved Prior to
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~DAVA PHARMS INC~20MG~N~018415~001~~Jul 27, 198
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~DAVA PHARMS INC~40MG~N~018415~002~~Jul 27, 198
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~DAVA PHARMS INC~80MG~N~018415~003~~Nov 26, 198
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~EXCELLIUM~20MG~A~077293~001~AB~Nov 9, 2005~No~
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~INTL MEDICATION~20MG~N~018753~001~~Feb 28, 198
4~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~INTL MEDICATION~40MG~N~018753~002~~Feb 28, 198
4~No~DISCN~INTERNATIONAL MEDICATION SYSTEMS LTD

FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~IPCA LABS LTD~20MG~A~078010~001~AB~Sep 18, 200
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~IVAX SUB TEVA PHARMS~20MG~N~018413~001~AB~Nov
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~IVAX SUB TEVA PHARMS~40MG~N~018413~002~AB~Nov
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~KALAPHARM~20MG~N~018868~001~~Jun 28, 1983~No~D
ISCN~KALAPHARM INC
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~KALAPHARM~40MG~N~018868~002~~Jun 28, 1983~No~D
ISCN~KALAPHARM INC
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~MUTUAL PHARM~20MG~A~070043~001~~Sep 26, 1985~N
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~MUTUAL PHARM~40MG~N~018790~001~~Nov 29, 1983~N
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~MUTUAL PHARM~80MG~A~070100~001~~Jan 26, 1988~N
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~MYLAN~20MG~N~018487~001~AB~Approved Prior to J
an 1, 1982~No~RX~MYLAN PHARMACEUTICALS INC
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~MYLAN~40MG~N~018487~002~AB~Approved Prior to J
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~MYLAN~80MG~A~070082~001~AB~Oct 29, 1986~No~RX~
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~ROXANE~20MG~N~018823~001~AB~Nov 10, 1983~No~RX
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~ROXANE~40MG~N~018823~002~AB~Nov 10, 1983~No~RX
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~ROXANE~80MG~A~070086~001~AB~Jan 24, 1986~No~RX
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~SANDOZ~20MG~N~018569~002~AB~Approved Prior to
Jan 1, 1982~No~RX~SANDOZ INC
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~SANDOZ~40MG~N~018569~001~AB~Approved Prior to
Jan 1, 1982~No~RX~SANDOZ INC
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~SANDOZ~40MG~N~018750~002~~Jul 30, 1984~No~DISC
N~SANDOZ INC
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~SANDOZ~80MG~N~018569~005~AB~Aug 14, 1984~No~RX
~SANDOZ INC
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~SUN PHARM INDS INC~20MG~A~091258~001~AB~Apr 1,
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~SUPERPHARM~20MG~N~018370~002~~Jun 26, 1984~No~
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~SUPERPHARM~40MG~N~018370~001~~Feb 10, 1983~No~
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~VINTAGE PHARMS~20MG~A~076796~001~AB~Mar 26, 20
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WARNER CHILCOTT~20MG~N~018419~001~~Jan 31, 198
3~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WARNER CHILCOTT~40MG~N~018419~002~~Jan 31, 198

FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WARNER CHILCOTT~80MG~N~018419~003~~Nov 13, 198
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~20MG~A~070412~001~~Feb 26, 1986~No
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~20MG~A~070449~001~~Nov 22, 1985~No
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~20MG~A~071379~001~~Jan 2, 1987~No~
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~20MG~N~018369~001~~May 14, 1982~No
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~40MG~A~070413~001~~Feb 26, 1986~No
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~40MG~A~070450~001~~Nov 22, 1985~No
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~40MG~N~018369~002~~May 14, 1982~No
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~80MG~A~070528~001~~Jan 7, 1986~No~
FUROSEMIDE~TABLET;ORAL~FUROSEMIDE~WATSON LABS~80MG~A~071594~001~~Feb 9, 1988~No~
FURAZOLIDONE~TABLET;ORAL~FUROXONE~SHIRE~100MG~N~011270~002~~Approved Prior to Ja
n 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
PERAMPANEL~TABLET;ORAL~FYCOMPA~EISAI INC~2MG~N~202834~001~~Oct 22, 2012~No~RX~EI
SAI INC
SAI INC
SAI INC
SAI INC
PERAMPANEL~TABLET;ORAL~FYCOMPA~EISAI INC~10MG~N~202834~005~~Oct 22, 2012~No~RX~E
ISAI INC
PERAMPANEL~TABLET;ORAL~FYCOMPA~EISAI INC~12MG~N~202834~006~~Oct 22, 2012~Yes~RX~
EISAI INC
GABAPENTIN~TABLET;ORAL~GABAPENTIN~ACI HEALTHCARE LTD~600MG~A~203244~002~AB~Jul 1
2, 2013~No~RX~ACI HEALTHCARE LTD
GABAPENTIN~TABLET;ORAL~GABAPENTIN~ACI HEALTHCARE LTD~800MG~A~203244~001~AB~Jul 1
2, 2013~No~RX~ACI HEALTHCARE LTD
GABAPENTIN~TABLET;ORAL~GABAPENTIN~ACTAVIS ELIZABETH~600MG~A~075694~001~AB~Oct 21
GABAPENTIN~TABLET;ORAL~GABAPENTIN~ACTAVIS ELIZABETH~800MG~A~075694~002~AB~Oct 21
GABAPENTIN~TABLET;ORAL~GABAPENTIN~APOTEX INC~100MG~A~077894~001~AB~Oct 10, 2006~
GABAPENTIN~TABLET;ORAL~GABAPENTIN~APOTEX INC~600MG~A~077661~004~AB~Sep 13, 2006~
GABAPENTIN~TABLET;ORAL~GABAPENTIN~APOTEX INC~800MG~A~077661~005~AB~Sep 13, 2006~
GABAPENTIN~TABLET;ORAL~GABAPENTIN~AUROBINDO PHARMA LTD~600MG~A~200651~001~AB~Oct
GABAPENTIN~TABLET;ORAL~GABAPENTIN~AUROBINDO PHARMA LTD~800MG~A~200651~002~AB~Oct
GABAPENTIN~TABLET;ORAL~GABAPENTIN~GLENMARK GENERICS~600MG~A~077662~001~AB~Aug 18
GABAPENTIN~TABLET;ORAL~GABAPENTIN~GLENMARK GENERICS~800MG~A~077662~002~AB~Aug 18

GABAPENTIN~TABLET;ORAL~GABAPENTIN~HIKMA PHARMS~600MG~A~078782~001~AB~Jul 21, 201
GABAPENTIN~TABLET;ORAL~GABAPENTIN~HIKMA PHARMS~800MG~A~078782~002~AB~Jul 21, 201
GABAPENTIN~TABLET;ORAL~GABAPENTIN~INVAGEN PHARMS~600MG~A~202764~001~AB~Oct 16, 2
GABAPENTIN~TABLET;ORAL~GABAPENTIN~INVAGEN PHARMS~800MG~A~202764~002~AB~Oct 16, 2
GABAPENTIN~TABLET;ORAL~GABAPENTIN~IVAX SUB TEVA PHARMS~100MG~A~076017~001~AB~Apr
GABAPENTIN~TABLET;ORAL~GABAPENTIN~MYLAN PHARMS INC~600MG~A~090335~001~AB~Jun 1,
GABAPENTIN~TABLET;ORAL~GABAPENTIN~MYLAN PHARMS INC~800MG~A~090335~002~AB~Jun 1,
GABAPENTIN~TABLET;ORAL~GABAPENTIN~RANBAXY~600MG~A~076605~001~~Sep 14, 2005~No~DI
SCN~RANBAXY LABORATORIES LTD
GABAPENTIN~TABLET;ORAL~GABAPENTIN~RANBAXY~800MG~A~076605~002~~Sep 14, 2005~No~DI
SCN~RANBAXY LABORATORIES LTD
GABAPENTIN~TABLET;ORAL~GABAPENTIN~SANDOZ~600MG~A~076120~001~~Jan 27, 2006~No~DIS
CN~SANDOZ INC
GABAPENTIN~TABLET;ORAL~GABAPENTIN~SANDOZ~600MG~A~076877~001~~Jul 6, 2006~No~DISC
N~SANDOZ INC
GABAPENTIN~TABLET;ORAL~GABAPENTIN~SANDOZ~800MG~A~076120~002~~Jan 27, 2006~No~DIS
CN~SANDOZ INC
GABAPENTIN~TABLET;ORAL~GABAPENTIN~SANDOZ~800MG~A~076877~002~~Jul 6, 2006~No~DISC
N~SANDOZ INC
GABAPENTIN~TABLET;ORAL~GABAPENTIN~SUN PHARM INDS LTD~600MG~A~077525~001~AB~Aug 2
GABAPENTIN~TABLET;ORAL~GABAPENTIN~SUN PHARM INDS LTD~800MG~A~077525~002~AB~Aug 2
GABAPENTIN~TABLET;ORAL~GABAPENTIN~TEVA~600MG~A~075827~001~~Dec 15, 2004~No~DISCN
GABAPENTIN~TABLET;ORAL~GABAPENTIN~TEVA~800MG~A~075827~002~~Dec 15, 2004~No~DISCN
GABAPENTIN~TABLET;ORAL~GABAPENTIN~ZYDUS PHARMS USA INC~600MG~A~078926~001~AB~Feb
GABAPENTIN~TABLET;ORAL~GABAPENTIN~ZYDUS PHARMS USA INC~800MG~A~078926~002~AB~Feb
TIAGABINE HYDROCHLORIDE~TABLET;ORAL~GABITRIL~CEPHALON~2MG~N~020646~005~AB~Apr 16
, 1999~No~RX~CEPHALON INC
TIAGABINE HYDROCHLORIDE~TABLET;ORAL~GABITRIL~CEPHALON~4MG~N~020646~001~AB~Sep 30
, 1997~Yes~RX~CEPHALON INC
TIAGABINE HYDROCHLORIDE~TABLET;ORAL~GABITRIL~CEPHALON~6MG~N~020646~006~~Nov 29,
2005~No~DISCN~CEPHALON INC
TIAGABINE HYDROCHLORIDE~TABLET;ORAL~GABITRIL~CEPHALON~12MG~N~020646~002~~Sep 30,
1997~No~RX~CEPHALON INC
1997~No~RX~CEPHALON INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~ACTAVIS ELIZABETH~
EQ 4MG BASE~A~077585~001~~Sep 15, 2009~No~DISCN~ACTAVIS ELIZABETH LLC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~APOTEX INC~EQ 4MG
BASE~A~077781~001~AB~Sep 27, 2011~No~RX~APOTEX INC.
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~AUROBINDO PHARMA L
TD~EQ 4MG BASE~A~090957~001~AB~Mar 29, 2011~No~RX~AUROBINDO PHARMA LIMITED
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~BARR~EQ 4MG BASE~A
~077605~001~AB~Aug 28, 2008~No~RX~BARR LABORATORIES INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~BARR~EQ 8MG BASE~A
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~BARR~EQ 12MG BASE~
A~077605~003~AB~Aug 28, 2008~No~RX~BARR LABORATORIES INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~DR REDDYS LABS LTD
~EQ 4MG BASE~A~077593~001~AB~Sep 11, 2008~No~RX~DR REDDYS LABORATORIES LTD
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~MYLAN~EQ 4MG BASE~
A~077590~001~AB~May 29, 2009~No~RX~MYLAN PHARMACEUTICALS INC
A~077603~001~AB~Aug 28, 2008~No~RX~MYLAN PHARMACEUTICALS INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~MYLAN~EQ 12MG BASE
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~MYLAN~EQ 12MG BASE
~A~077603~003~AB~Aug 28, 2008~No~RX~MYLAN PHARMACEUTICALS INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~ROXANE~EQ 4MG BASE
~A~077608~001~AB~Feb 11, 2009~No~RX~ROXANE LABORATORIES INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~ROXANE~EQ 8MG BASE
~A~077608~002~AB~Feb 11, 2009~No~RX~ROXANE LABORATORIES INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~ROXANE~EQ 12MG BAS
E~A~077608~003~AB~Feb 11, 2009~No~RX~ROXANE LABORATORIES INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~SANDOZ~EQ 4MG BASE
~A~077589~001~AB~Jun 22, 2009~No~RX~SANDOZ INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~SANDOZ~EQ 8MG BASE
~A~077589~002~AB~Jun 22, 2009~No~RX~SANDOZ INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~SANDOZ~EQ 12MG BAS
E~A~077589~003~AB~Jun 22, 2009~No~RX~SANDOZ INC
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~TEVA PHARMS~EQ 4MG
BASE~A~077587~001~AB~Jul 9, 2009~No~RX~TEVA PHARMACEUTICALS USA
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~TEVA PHARMS~EQ 8MG

GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~TEVA PHARMS~EQ 12M
G BASE~A~077587~003~AB~Jul 9, 2009~No~RX~TEVA PHARMACEUTICALS USA
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~YABAO PHARM~EQ 4MG
BASE~A~077604~001~~Feb 6, 2009~No~DISCN~YABAO PHARMACEUTICAL CO LTD BEIJING
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~YABAO PHARM~EQ 8MG
BASE~A~077604~002~~Feb 6, 2009~No~DISCN~YABAO PHARMACEUTICAL CO LTD BEIJING
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~YABAO PHARM~EQ 12M
G BASE~A~077604~003~~Feb 6, 2009~No~DISCN~YABAO PHARMACEUTICAL CO LTD BEIJING
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~GALANTAMINE HYDROBROMIDE~ZYDUS PHARMS USA I
NC~EQ 4MG BASE~A~078898~001~AB~Feb 17, 2011~No~RX~ZYDUS PHARMACEUTICALS USA INC
SULFAMETHOXAZOLE~TABLET;ORAL~GANTANOL~ROCHE~500MG~N~012715~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
SULFAMETHOXAZOLE~TABLET;ORAL~GANTANOL-DS~ROCHE~1GM~N~012715~003~~Approved Prior
to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
SULFISOXAZOLE~TABLET;ORAL~GANTRISIN~ROCHE~500MG~N~006525~001~~Approved Prior to
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~APOTEX~600MG~A~075034~001~AB~Jul 20, 1998~No
~RX~APOTEX INC
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~BLU CARIBE~600MG~A~078012~001~AB~Mar 26, 200
7~No~RX~BLU CARIBE INC
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~DAVA PHARMS INC~600MG~A~074270~001~AB~Sep 27
, 1993~No~RX~DAVA PHARMACEUTICALS INC
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~HIKMA PHARMS~600MG~A~078599~001~AB~Aug 16, 2
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~IMPAX PHARMS~600MG~A~078207~001~AB~Jun 1, 20
07~No~RX~IMPAX PHARMACEUTICALS
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~INVAGEN PHARMS~600MG~A~077836~001~AB~Jul 27,
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~MYLAN~600MG~A~074452~001~~Feb 16, 1995~No~DI
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~NORTHSTAR HLTHCARE~600MG~A~079072~001~AB~Sep
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~PUREPAC PHARM~600MG~A~074360~001~~Aug 31, 19
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~SANDOZ~600MG~A~074615~001~~Sep 29, 1995~No~D
ISCN~SANDOZ INC
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~SUN PHARM INDS INC~600MG~A~079239~001~AB~Dec
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~TEVA~600MG~A~074256~001~AB~Oct 31, 1993~No~R
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~WATSON LABS~600MG~A~074156~001~~Oct 24, 1994
GEMFIBROZIL~TABLET;ORAL~GEMFIBROZIL~WATSON LABS~600MG~A~074442~001~~Apr 28, 1995
METHARBITAL~TABLET;ORAL~GEMONIL~ABBVIE~100MG~N~008322~001~~Approved Prior to Jan
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~GEN-XENE~ALRA~3.75MG~A~071787~001~AB~Apr 26,
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~GEN-XENE~ALRA~7.5MG~A~071788~001~AB~Apr 26,
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~GEN-XENE~ALRA~15MG~A~071789~001~AB~Apr 26, 1
CARBENICILLIN INDANYL SODIUM~TABLET;ORAL~GEOCILLIN~PFIZER~EQ 382MG BASE~N~050435
~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
ERGOLOID MESYLATES~TABLET;ORAL~GERIMAL~WATSON LABS~1MG~A~088207~001~~Mar 22, 198

BALSALAZIDE DISODIUM~TABLET;ORAL~GIAZO~SALIX PHARMS~1.1GM~N~022205~001~~Feb 3, 2
012~Yes~RX~SALIX PHARMACEUTICALS INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~GILDESS 24 FE~VINTAGE PHARM
S~0.02MG;1MG~A~090293~001~AB~Dec 1, 2014~No~RX~VINTAGE PHARMACEUTICALS
AFATINIB DIMALEATE~TABLET;ORAL~GILOTRIF~BOEHRINGER INGELHEIM~EQ 20MG BASE~N~2012
92~001~~Jul 12, 2013~No~RX~BOEHRINGER INGELHEIM
92~002~~Jul 12, 2013~No~RX~BOEHRINGER INGELHEIM
92~003~~Jul 12, 2013~Yes~RX~BOEHRINGER INGELHEIM
IMATINIB MESYLATE~TABLET;ORAL~GLEEVEC~NOVARTIS~EQ 100MG BASE~N~021588~001~~Apr 1
IMATINIB MESYLATE~TABLET;ORAL~GLEEVEC~NOVARTIS~EQ 400MG BASE~N~021588~002~~Apr 1
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~ACCORD HLTHCARE~1MG~A~078181~001~AB~Aug 23,
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~ACTAVIS LABS FL INC~1MG~A~076995~001~AB~Apr
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~AUROBINDO PHARMA LTD~1MG~A~202759~001~AB~Jun
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~CARLSBAD~1MG~A~077911~001~AB~Sep 22, 2009~No
~RX~CARLSBAD TECHNOLOGY INC
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~COREPHARMA~1MG~A~077274~001~~Oct 6, 2005~No~
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~DR REDDYS LABS LTD~1MG~A~077091~001~AB~Oct 6
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~HIKMA PHARMS~1MG~A~078952~001~AB~Aug 1, 2013
~No~RX~HIKMA PHARMACEUTICALS
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~INDOCO REMEDIES~1MG~A~202112~001~AB~Apr 17,
2013~No~RX~INDOCO REMEDIES LTD

GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~INVAGEN PHARMS~1MG~A~077295~001~AB~Oct 6, 20
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~MICRO LABS LTD INDIA~1MG~A~091220~001~AB~Jun
29, 2012~No~RX~MICRO LABS LTD INDIA
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~MICRO LABS LTD INDIA~3MG~A~091220~003~~Jun 2
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~MICRO LABS LTD INDIA~6MG~A~091220~005~~Jun 2
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~MYLAN~1MG~A~077486~001~~Feb 10, 2006~No~DISC
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~MYLAN~1MG~A~077624~001~AB~Nov 28, 2005~No~RX
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~RANBAXY~3MG~A~077366~001~~Oct 6, 2005~No~DIS
CN~RANBAXY LABORATORIES LTD
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~RANBAXY~6MG~A~077366~002~~Oct 6, 2005~No~DIS
CN~RANBAXY LABORATORIES LTD
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~RANBAXY LABS LTD~1MG~A~076875~001~~Oct 6, 20
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~TEVA~1MG~A~076802~001~AB~Oct 6, 2005~No~RX~T
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~VINTAGE~1MG~A~077370~001~AB~Dec 23, 2005~No~
GLIMEPIRIDE~TABLET;ORAL~GLIMEPIRIDE~WATSON LABS~1MG~A~077280~001~~Feb 3, 2006~No

GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~ACCORD HLTHCARE~5MG~A~074550~001~AB~Sep 11, 1997
~No~RX~ACCORD HEALTHCARE INC
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~ACCORD HLTHCARE~10MG~A~074550~002~AB~Sep 11, 199
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~APOTEX~5MG~A~075795~001~AB~Jun 13, 2001~No~RX~AP
OTEX INC
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~APOTEX~10MG~A~075795~002~AB~Jun 13, 2001~No~RX~A
POTEX INC
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~BARR LABS INC~5MG~A~074619~001~~Apr 4, 1997~No~D
ISCN~BARR LABORATORIES INC
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~BARR LABS INC~10MG~A~074619~002~~Apr 4, 1997~No~
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~IVAX SUB TEVA PHARMS~5MG~A~074497~001~AB~Aug 31,
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~IVAX SUB TEVA PHARMS~10MG~A~074497~002~AB~Aug 31
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~MYLAN~5MG~A~074226~001~AB~May 10, 1994~No~RX~MYL
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~MYLAN~5MG~A~074438~001~AB~Jun 20, 1995~No~RX~MYL
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~MYLAN~10MG~A~074226~002~AB~May 10, 1994~No~RX~MY
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~MYLAN~10MG~A~074438~002~AB~Jun 20, 1995~No~RX~MY
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~SANDOZ~5MG~A~074305~001~AB~Apr 7, 1995~No~RX~SAN
DOZ INC
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~SANDOZ~5MG~A~074542~001~~Jun 20, 1995~No~DISCN~S
ANDOZ INC
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~SANDOZ~10MG~A~074305~002~AB~Apr 7, 1995~No~RX~SA
NDOZ INC
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~SANDOZ~10MG~A~074542~002~~Jun 20, 1995~No~DISCN~
SANDOZ INC
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~SUN PHARM INDS INC~5MG~A~077820~001~AB~Jul 11, 2
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~SUN PHARM INDS INC~10MG~A~077820~002~AB~Jul 11,
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~TEVA~5MG~A~074387~001~~Mar 4, 1996~No~DISCN~TEVA
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~TEVA~10MG~A~074387~002~~Mar 4, 1996~No~DISCN~TEV
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~VINTAGE PHARMS LLC~5MG~A~074378~001~~Nov 28, 199
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~VINTAGE PHARMS LLC~10MG~A~074378~002~~Nov 28, 19
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~WATSON LABS~5MG~A~074223~001~AB~Feb 27, 1995~No~
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~WATSON LABS~5MG~A~074370~001~~Nov 22, 1994~No~DI
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~WATSON LABS~10MG~A~074223~002~AB~Feb 27, 1995~No
GLIPIZIDE~TABLET;ORAL~GLIPIZIDE~WATSON LABS~10MG~A~074370~002~~Nov 22, 1994~No~D
GLIPIZIDE; METFORMIN HYDROCHLORIDE~TABLET;ORAL~GLIPIZIDE AND METFORMIN HYDROCHLO
RIDE~COREPHARMA~2.5MG;250MG~A~077507~001~AB~Oct 27, 2005~No~RX~COREPHARMA LLC
RIDE~COREPHARMA~2.5MG;500MG~A~077507~002~AB~Oct 27, 2005~No~RX~COREPHARMA LLC

RIDE~COREPHARMA~5MG;500MG~A~077507~003~AB~Oct 27, 2005~No~RX~COREPHARMA LLC
RIDE~HERITAGE PHARMS INC~2.5MG;250MG~A~078728~001~AB~Jun 23, 2010~No~RX~HERITAGE
PHARMACEUTICALS INC
PHARMACEUTICALS INC
RIDE~HERITAGE PHARMS INC~5MG;500MG~A~078728~003~AB~Jun 23, 2010~No~RX~HERITAGE P
HARMACEUTICALS INC
RIDE~MYLAN~2.5MG;250MG~A~078083~001~AB~Apr 12, 2007~No~RX~MYLAN PHARMACEUTICALS
INC
RIDE~MYLAN~2.5MG;500MG~A~078083~002~AB~Apr 12, 2007~No~RX~MYLAN PHARMACEUTICALS
INC
RIDE~MYLAN~5MG;500MG~A~078083~003~AB~Apr 12, 2007~No~RX~MYLAN PHARMACEUTICALS IN
C
RIDE~SUN PHARM INDS INC~2.5MG;250MG~A~077620~001~AB~Jan 11, 2008~No~RX~SUN PHARM
ACEUTICAL INDUSTRIES INC
RIDE~SUN PHARM INDS INC~2.5MG;500MG~A~077620~002~AB~Jan 11, 2008~No~RX~SUN PHARM
ACEUTICAL INDUSTRIES INC
RIDE~SUN PHARM INDS INC~5MG;500MG~A~077620~003~AB~Jan 11, 2008~No~RX~SUN PHARMAC
EUTICAL INDUSTRIES INC
RIDE~TEVA PHARMS~2.5MG;250MG~A~077270~001~AB~Oct 28, 2005~No~RX~TEVA PHARMACEUTI
CALS USA
RIDE~TEVA PHARMS~2.5MG;500MG~A~077270~002~AB~Oct 28, 2005~No~RX~TEVA PHARMACEUTI
CALS USA
RIDE~TEVA PHARMS~5MG;500MG~A~077270~003~AB~Oct 28, 2005~Yes~RX~TEVA PHARMACEUTIC
ALS USA
RIDE~ZYDUS PHARMS USA INC~2.5MG;250MG~A~078905~001~AB~Jan 31, 2011~No~RX~ZYDUS P
RIDE~ZYDUS PHARMS USA INC~2.5MG;500MG~A~078905~002~AB~Jan 31, 2011~No~RX~ZYDUS P
RIDE~ZYDUS PHARMS USA INC~5MG;500MG~A~078905~003~AB~Jan 31, 2011~No~RX~ZYDUS PHA
CHLORPROPAMIDE~TABLET;ORAL~GLUCAMIDE~TEVA PHARMS USA~250MG~A~088641~001~~Oct 11,
METFORMIN HYDROCHLORIDE~TABLET;ORAL~GLUCOPHAGE~BRISTOL MYERS SQUIBB~1GM~N~020357
~005~AB~Nov 5, 1998~Yes~RX~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTI
TUTE
METFORMIN HYDROCHLORIDE~TABLET;ORAL~GLUCOPHAGE~BRISTOL MYERS SQUIBB~500MG~N~0203
57~001~AB~Mar 3, 1995~No~RX~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INST
ITUTE
57~003~~Nov 5, 1998~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INS
TITUTE
57~004~~Nov 5, 1998~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INS

TITUTE
57~002~AB~Mar 3, 1995~No~RX~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INST
ITUTE
GLIPIZIDE~TABLET;ORAL~GLUCOTROL~PFIZER~2.5MG~N~017783~003~~May 11, 1993~No~DISCN
~PFIZER INC
GLIPIZIDE~TABLET;ORAL~GLUCOTROL~PFIZER~5MG~N~017783~001~AB~May 8, 1984~No~RX~PFI
ZER INC
GLIPIZIDE~TABLET;ORAL~GLUCOTROL~PFIZER~10MG~N~017783~002~AB~May 8, 1984~Yes~RX~P
FIZER INC
GLYBURIDE; METFORMIN HYDROCHLORIDE~TABLET;ORAL~GLUCOVANCE~BRISTOL MYERS SQUIBB~1
.25MG;250MG~N~021178~001~AB~Jul 31, 2000~No~RX~BRISTOL MYERS SQUIBB
.5MG;500MG~N~021178~002~AB~Jul 31, 2000~Yes~RX~BRISTOL MYERS SQUIBB
MG;500MG~N~021178~003~AB~Jul 31, 2000~No~RX~BRISTOL MYERS SQUIBB
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~HALSEY~250MG~A~089458~001~~Oct 10, 1986~No
~DISCN~HALSEY DRUG CO INC
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~HALSEY~500MG~A~089459~001~~Oct 10, 1986~No
~DISCN~HALSEY DRUG CO INC
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~LANNETT~250MG~A~083475~001~~Approved Prior
to Jan 1, 1982~No~DISCN~LANNETT CO INC
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~LANNETT~500MG~A~085571~001~~Approved Prior
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~SANDOZ~500MG~A~083234~002~~Approved Prior
to Jan 1, 1982~No~DISCN~SANDOZ INC
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~UCB INC~500MG~A~085171~001~~Approved Prior
to Jan 1, 1982~No~DISCN~UCB INC
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~VITARINE~500MG~A~087297~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~WATSON LABS~500MG~A~084362~001~~Approved P
GLUTETHIMIDE~TABLET;ORAL~GLUTETHIMIDE~WATSON LABS~500MG~A~085763~001~~Approved P
GLYBURIDE~TABLET;ORAL~GLYBURIDE~ACTAVIS ELIZABETH~1.5MG~A~075947~001~~Nov 14, 20
GLYBURIDE~TABLET;ORAL~GLYBURIDE~ACTAVIS ELIZABETH~3MG~A~075947~002~~Nov 14, 2002
GLYBURIDE~TABLET;ORAL~GLYBURIDE~ACTAVIS ELIZABETH~6MG~A~075947~003~~Nov 14, 2002
GLYBURIDE~TABLET;ORAL~GLYBURIDE~AUROBINDO PHARMA~1.25MG~A~077537~001~AB~Oct 18,
GLYBURIDE~TABLET;ORAL~GLYBURIDE~AUROBINDO PHARMA~2.5MG~A~077537~002~AB~Oct 18, 2
GLYBURIDE~TABLET;ORAL~GLYBURIDE~AUROBINDO PHARMA~5MG~A~077537~003~AB~Oct 18, 200
GLYBURIDE~TABLET;ORAL~GLYBURIDE~COREPHARMA~1.25MG~A~076257~001~AB~Jun 27, 2002~N
o~RX~COREPHARMA LLC
GLYBURIDE~TABLET;ORAL~GLYBURIDE~COREPHARMA~2.5MG~A~076257~002~AB~Jun 27, 2002~No
~RX~COREPHARMA LLC
GLYBURIDE~TABLET;ORAL~GLYBURIDE~COREPHARMA~5MG~A~076257~003~AB~Jun 27, 2002~No~R
X~COREPHARMA LLC
GLYBURIDE~TABLET;ORAL~GLYBURIDE~HERITAGE PHARMS INC~1.25MG~A~090937~001~AB~Feb 2
8, 2011~No~RX~HERITAGE PHARMACEUTICALS INC
GLYBURIDE~TABLET;ORAL~GLYBURIDE~HERITAGE PHARMS INC~2.5MG~A~090937~002~AB~Feb 28
, 2011~No~RX~HERITAGE PHARMACEUTICALS INC
GLYBURIDE~TABLET;ORAL~GLYBURIDE~HERITAGE PHARMS INC~5MG~A~090937~003~AB~Feb 28,
2011~No~RX~HERITAGE PHARMACEUTICALS INC
GLYBURIDE~TABLET;ORAL~GLYBURIDE~TEVA~1.25MG~A~074388~001~AB~Aug 29, 1995~No~RX~T

GLYBURIDE~TABLET;ORAL~GLYBURIDE~TEVA~2.5MG~A~074388~002~AB~Aug 29, 1995~No~RX~TE
GLYBURIDE~TABLET;ORAL~GLYBURIDE~TEVA~5MG~A~074388~003~AB~Aug 29, 1995~Yes~RX~TEV
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~DAVA PHARMS INC~1.5MG~A~074591~001~
AB~Dec 22, 1997~No~RX~DAVA PHARMACEUTICALS INC
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~DAVA PHARMS INC~3MG~A~074591~002~AB
~Dec 22, 1997~No~RX~DAVA PHARMACEUTICALS INC
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~DAVA PHARMS INC~4.5MG~A~074591~003~
AB~Dec 22, 1997~No~RX~DAVA PHARMACEUTICALS INC
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~DAVA PHARMS INC~6MG~A~074591~004~AB
~Dec 22, 1997~No~RX~DAVA PHARMACEUTICALS INC
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~HIKMA~1.5MG~A~075890~001~AB~Jul 31,
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~HIKMA~3MG~A~075890~002~AB~Jul 31, 2
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~HIKMA~6MG~A~075890~003~AB~Jul 31, 2
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~MYLAN~1.5MG~A~074792~001~AB~Jun 26,
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~MYLAN~3MG~A~074792~002~AB~Jun 26, 1
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~MYLAN~6MG~A~074792~003~AB~Aug 17, 1
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~SANDOZ~1.5MG~A~075174~001~~Jun 22,
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~SANDOZ~3MG~A~075174~002~~Jun 22, 19
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~SANOFI AVENTIS US~1.5MG~N~020055~00
1~~Apr 17, 1992~No~DISCN~SANOFI AVENTIS US LLC
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~SANOFI AVENTIS US~3MG~N~020055~002~
~Apr 17, 1992~No~DISCN~SANOFI AVENTIS US LLC
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~SANOFI AVENTIS US~6MG~N~020055~003~
~Mar 8, 2000~No~DISCN~SANOFI AVENTIS US LLC
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~TEVA~1.5MG~A~074686~001~AB~Apr 20,
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~TEVA~3MG~A~074686~002~AB~Apr 20, 19
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~TEVA~4.5MG~A~074686~003~AB~Apr 20,
GLYBURIDE~TABLET;ORAL~GLYBURIDE (MICRONIZED)~TEVA~6MG~A~074686~004~AB~Apr 20, 19
GLYBURIDE; METFORMIN HYDROCHLORIDE~TABLET;ORAL~GLYBURIDE AND METFORMIN HYDROCHLO
RIDE~ACTAVIS ELIZABETH~1.25MG;250MG~A~076716~001~AB~Jun 28, 2005~No~RX~ACTAVIS E
LIZABETH LLC
RIDE~ACTAVIS ELIZABETH~2.5MG;500MG~A~076716~002~AB~Jun 28, 2005~No~RX~ACTAVIS EL
IZABETH LLC
RIDE~ACTAVIS ELIZABETH~5MG;500MG~A~076716~003~AB~Jun 28, 2005~No~RX~ACTAVIS ELIZ
ABETH LLC
RIDE~AUROBINDO PHARMA~1.25MG;250MG~A~077870~001~AB~Nov 14, 2007~No~RX~AUROBINDO
PHARMA LTD
RIDE~AUROBINDO PHARMA~2.5MG;500MG~A~077870~002~AB~Nov 14, 2007~No~RX~AUROBINDO P
HARMA LTD
RIDE~AUROBINDO PHARMA~5MG;500MG~A~077870~003~AB~Nov 14, 2007~No~RX~AUROBINDO PHA
RMA LTD
RIDE~COREPHARMA~1.25MG;250MG~A~076731~001~AB~Nov 19, 2004~No~RX~COREPHARMA LLC
RIDE~COREPHARMA~2.5MG;500MG~A~076731~002~AB~Nov 19, 2004~No~RX~COREPHARMA LLC
RIDE~COREPHARMA~5MG;500MG~A~076731~003~AB~Nov 19, 2004~No~RX~COREPHARMA LLC
PHARMACEUTICALS INC
PHARMACEUTICALS INC
RIDE~HERITAGE PHARMS INC~5MG;500MG~A~079009~003~AB~Jun 3, 2009~No~RX~HERITAGE PH
ARMACEUTICALS INC
RIDE~IVAX SUB TEVA PHARMS~1.25MG;250MG~A~076345~001~AB~Feb 18, 2004~No~RX~IVAX P
RIDE~IVAX SUB TEVA PHARMS~2.5MG;500MG~A~076345~002~AB~Feb 18, 2004~No~RX~IVAX PH
ARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
RIDE~IVAX SUB TEVA PHARMS~5MG;500MG~A~076345~003~AB~Feb 18, 2004~No~RX~IVAX PHAR
MACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
RIDE~TEVA~1.25MG;250MG~A~076821~001~~Jan 27, 2005~No~DISCN~TEVA PHARMACEUTICALS
USA INC
RIDE~TEVA~2.5MG;500MG~A~076821~002~~Jan 27, 2005~No~DISCN~TEVA PHARMACEUTICALS U
SA INC
RIDE~TEVA~5MG;500MG~A~076821~003~~Jan 27, 2005~No~DISCN~TEVA PHARMACEUTICALS USA
INC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~AUROLIFE PHARMA LLC~1MG~A~202675~001~A
A~Apr 15, 2013~No~RX~AUROLIFE PHARMA LLC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~COREPHARMA~1MG~A~040568~001~~Dec 22, 2
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~COREPHARMA~2MG~A~040568~002~~Dec 22, 2
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~DR REDDYS LABS LTD~1MG~A~040847~001~AA
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~DR REDDYS LABS LTD~2MG~A~040847~002~AA
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~EXCELLIUM~1MG~A~090195~001~AA~Sep 21,
2012~No~RX~EXCELLIUM PHARMACEUTICAL INC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~EXCELLIUM~2MG~A~090195~002~AA~Sep 21,
2012~No~RX~EXCELLIUM PHARMACEUTICAL INC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~HIKMA PHARMS LLC~1MG~A~040836~001~~Mar
5, 2009~No~DISCN~HIKMA PHARMACEUTICALS LLC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~HIKMA PHARMS LLC~2MG~A~040836~002~~Mar
5, 2009~No~DISCN~HIKMA PHARMACEUTICALS LLC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~NEXGEN PHARMA~1.5MG~A~091522~001~AA~Ma
r 12, 2012~No~RX~NEXGEN PHARMA INC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~PAR PHARM~1MG~A~040653~001~AA~Aug 31,
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~PAR PHARM~2MG~A~040653~002~AA~Aug 31,
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~RANBAXY~1MG~A~040844~001~AA~Aug 18, 20
09~No~RX~RANBAXY INC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~RANBAXY~2MG~A~040844~002~AA~Aug 18, 20
09~No~RX~RANBAXY INC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~STASON PHARMS~1MG~A~091182~001~AA~Feb
3, 2014~No~RX~STASON PHARMACEUTICALS INC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~STASON PHARMS~2MG~A~091182~002~AA~Feb
3, 2014~No~RX~STASON PHARMACEUTICALS INC
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~VINTAGE~1MG~A~040821~001~AA~Dec 29, 20
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~VINTAGE~2MG~A~040821~002~AA~Dec 29, 20
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~VINTAGE PHARMS~1MG~A~090020~001~AA~Oct
19, 2011~No~RX~VINTAGE PHARMACEUTICALS
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~VINTAGE PHARMS~2MG~A~090020~002~AA~Oct
GLYCOPYRROLATE~TABLET;ORAL~GLYCOPYRROLATE~WATSON LABS~1MG~A~085562~001~~Approved
GLYBURIDE~TABLET;ORAL~GLYNASE~PHARMACIA AND UPJOHN~1.5MG~N~020051~001~AB~Mar 4,
1992~No~RX~PHARMACIA AND UPJOHN CO
GLYBURIDE~TABLET;ORAL~GLYNASE~PHARMACIA AND UPJOHN~3MG~N~020051~002~AB~Mar 4, 19
GLYBURIDE~TABLET;ORAL~GLYNASE~PHARMACIA AND UPJOHN~4.5MG~N~020051~003~~Sep 24, 1
GLYBURIDE~TABLET;ORAL~GLYNASE~PHARMACIA AND UPJOHN~6MG~N~020051~004~AB~Sep 24, 1
MIGLITOL~TABLET;ORAL~GLYSET~PHARMACIA AND UPJOHN~25MG~N~020682~001~AA~Dec 18, 19
EMPAGLIFLOZIN; LINAGLIPTIN~TABLET;ORAL~GLYXAMBI~BOEHRINGER INGELHEIM~10MG;5MG~N~
206073~001~~Jan 30, 2015~No~RX~BOEHRINGER INGELHEIM
EMPAGLIFLOZIN; LINAGLIPTIN~TABLET;ORAL~GLYXAMBI~BOEHRINGER INGELHEIM~25MG;5MG~N~
206073~002~~Jan 30, 2015~Yes~RX~BOEHRINGER INGELHEIM
GABAPENTIN~TABLET;ORAL~GRALISE~DEPOMED INC~300MG~N~022544~001~BX~Jan 28, 2011~Ye
s~RX~DEPOMED INC
GABAPENTIN~TABLET;ORAL~GRALISE~DEPOMED INC~600MG~N~022544~002~BX~Jan 28, 2011~Ye
s~RX~DEPOMED INC
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~APOTEX INC~EQ 1M
G BASE~A~078843~001~AB~Feb 27, 2008~No~RX~APOTEX INC
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~BARR~EQ 1MG BASE
~A~078221~001~~Dec 31, 2007~No~DISCN~BARR LABORATORIES INC
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~CIPLA LTD~EQ 1MG
BASE~A~078037~001~AB~Feb 27, 2008~No~RX~CIPLA LTD
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~COREPHARMA~EQ 1M
G BASE~A~078260~001~AB~Dec 31, 2007~No~RX~COREPHARMA LLC
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~DR REDDYS LABS L
TD~EQ 1MG BASE~A~078846~001~AB~Feb 27, 2009~No~RX~DR REDDYS LABORATORIES LTD
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~MYLAN~EQ 1MG BAS
E~A~078725~001~AB~Jan 30, 2008~No~RX~MYLAN PHARMACEUTICALS INC
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~NATCO PHARMA~EQ
1MG BASE~A~078969~001~AB~Jun 22, 2009~No~RX~NATCO PHARMA LTD
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~ORCHID HLTHCARE~

EQ 1MG BASE~A~078678~001~AB~Feb 13, 2008~No~RX~ORCHID HEALTHCARE
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~ROXANE~EQ 1MG BA
SE~A~077842~001~AB~Dec 31, 2007~No~RX~ROXANE LABORATORIES INC
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~TARO~EQ 1MG BASE
~A~090817~001~AB~May 28, 2010~No~RX~TARO PHARMACEUTICALS USA INC
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~GRANISETRON HYDROCHLORIDE~TEVA PHARMS~EQ 1
MG BASE~A~078080~001~AB~Dec 31, 2007~Yes~RX~TEVA PHARMACEUTICALS USA
GRISEOFULVIN, MICROCRYSTALLINE~TABLET;ORAL~GRIFULVIN V~J AND J~125MG~A~060618~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~JOHNSON AND JOHNSON CONSUMER PRODUCTS
INC
INC
INC
GRISEOFULVIN, MICROCRYSTALLINE~TABLET;ORAL~GRIFULVIN V~VALEANT LUXEMBOURG~125MG~
A~062279~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS LUX
EMBOURG SARL
GRISEOFULVIN, MICROCRYSTALLINE~TABLET;ORAL~GRIFULVIN V~VALEANT LUXEMBOURG~250MG
for safety or efficacy reasons**~A~062279~002~~Approved Prior to Jan 1, 1982~No~
DISCN~VALEANT PHARMACEUTICALS LUXEMBOURG SARL
GRISEOFULVIN, MICROSIZE~TABLET;ORAL~GRIFULVIN V~VALEANT LUXEMBOURG~500MG~A~06227
9~003~AB~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS LUXEMBOURG
SARL
GRISEOFULVIN, ULTRAMICROSIZE~TABLET;ORAL~GRIS-PEG~VALEANT PHARMS INC~125MG~N~050
475~001~AB~Approved Prior to Jan 1, 1982~No~RX~VALEANT PHARMACEUTICALS INTERNATI
ONAL INC
GRISEOFULVIN, ULTRAMICROSIZE~TABLET;ORAL~GRIS-PEG~VALEANT PHARMS INC~250MG~N~050
475~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNAT
IONAL INC
GRISEOFULVIN, MICROCRYSTALLINE~TABLET;ORAL~GRISACTIN~WYETH AYERST~500MG~A~060212
GRISEOFULVIN, ULTRAMICROCRYSTALLINE~TABLET;ORAL~GRISACTIN ULTRA~WYETH AYERST~125
MG~A~062178~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIE
S
MG~A~062438~001~~Nov 17, 1983~No~DISCN~WYETH AYERST LABORATORIES
MG~A~062178~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIE
S
MG~A~062438~002~~Nov 17, 1983~No~DISCN~WYETH AYERST LABORATORIES
GRISEOFULVIN, MICROSIZE~TABLET;ORAL~GRISEOFULVIN~SANDOZ~250MG~A~091592~001~~Aug
GRISEOFULVIN, MICROSIZE~TABLET;ORAL~GRISEOFULVIN~SANDOZ~500MG~A~091592~002~AB~Au
g 7, 2013~No~RX~SANDOZ INC
GRISEOFULVIN, MICROSIZE~TABLET;ORAL~GRISEOFULVIN~SIGMAPHARM LABS LLC~500MG~A~202
482~001~AB~Oct 22, 2012~No~RX~SIGMAPHARM LABORATORIES LLC
GRISEOFULVIN, ULTRAMICROSIZE~TABLET;ORAL~GRISEOFULVIN, ULTRAMICROSIZE~RICONPHARM
A LLC~125MG~A~204371~001~AB~Jan 9, 2014~No~RX~RICONPHARMA LLC
GRISEOFULVIN, ULTRAMICROSIZE~TABLET;ORAL~GRISEOFULVIN, ULTRAMICROSIZE~RICONPHARM
A LLC~250MG~A~204371~002~AB~Jan 9, 2014~No~RX~RICONPHARMA LLC
GRISEOFULVIN, ULTRAMICROSIZE~TABLET;ORAL~GRISEOFULVIN,ULTRAMICROSIZE~SIGMAPHARM
LABS LLC~125MG~A~202545~001~AB~Oct 22, 2012~No~RX~SIGMAPHARM LABORATORIES LLC
GRISEOFULVIN, ULTRAMICROSIZE~TABLET;ORAL~GRISEOFULVIN,ULTRAMICROSIZE~SIGMAPHARM
LABS LLC~250MG~A~202545~002~AB~Oct 22, 2012~No~RX~SIGMAPHARM LABORATORIES LLC
GUANABENZ ACETATE~TABLET;ORAL~GUANABENZ ACETATE~ANI PHARMS INC~EQ 4MG BASE~A~074
149~001~~Apr 7, 1995~No~RX~ANI PHARMACEUTICALS INC

267~001~~Jun 1, 1994~No~DISCN~ANI PHARMACEUTICALS INC
149~002~~Apr 7, 1995~Yes~RX~ANI PHARMACEUTICALS INC
267~002~~Jun 1, 1994~No~DISCN~ANI PHARMACEUTICALS INC
GUANABENZ ACETATE~TABLET;ORAL~GUANABENZ ACETATE~SANDOZ~EQ 4MG BASE~A~074517~001~
~Sep 30, 1998~No~DISCN~SANDOZ INC
GUANABENZ ACETATE~TABLET;ORAL~GUANABENZ ACETATE~SANDOZ~EQ 8MG BASE~A~074517~002~
~Sep 30, 1998~No~DISCN~SANDOZ INC
GUANABENZ ACETATE~TABLET;ORAL~GUANABENZ ACETATE~WATSON LABS~EQ 4MG BASE~A~074025
GUANABENZ ACETATE~TABLET;ORAL~GUANABENZ ACETATE~WATSON LABS~EQ 8MG BASE~A~074025
GUANETHIDINE MONOSULFATE~TABLET;ORAL~GUANETHIDINE MONOSULFATE~WATSON LABS~EQ 10M
G SULFATE~A~086113~001~~Mar 26, 1985~No~DISCN~WATSON LABORATORIES INC
GUANETHIDINE MONOSULFATE~TABLET;ORAL~GUANETHIDINE MONOSULFATE~WATSON LABS~EQ 25M
G SULFATE~A~086114~001~~Mar 26, 1985~No~DISCN~WATSON LABORATORIES INC
GUANFACINE HYDROCHLORIDE~TABLET;ORAL~GUANFACINE HYDROCHLORIDE~AMNEAL PHARM~EQ 1M
G BASE~A~075109~001~AB~Nov 25, 1998~No~RX~AMNEAL PHARMACEUTICAL
GUANFACINE HYDROCHLORIDE~TABLET;ORAL~GUANFACINE HYDROCHLORIDE~AMNEAL PHARM~EQ 2M
G BASE~A~075109~002~AB~Nov 25, 1998~No~RX~AMNEAL PHARMACEUTICAL
GUANFACINE HYDROCHLORIDE~TABLET;ORAL~GUANFACINE HYDROCHLORIDE~EPIC PHARMA LLC~EQ
1MG BASE~A~074673~001~AB~Feb 28, 1997~No~RX~EPIC PHARMA LLC
GUANFACINE HYDROCHLORIDE~TABLET;ORAL~GUANFACINE HYDROCHLORIDE~EPIC PHARMA LLC~EQ
2MG BASE~A~074673~002~AB~Feb 28, 1997~No~RX~EPIC PHARMA LLC
GUANFACINE HYDROCHLORIDE~TABLET;ORAL~GUANFACINE HYDROCHLORIDE~MYLAN~EQ 1MG BASE~
A~074796~001~AB~Jan 27, 1997~No~RX~MYLAN PHARMACEUTICALS INC
GUANFACINE HYDROCHLORIDE~TABLET;ORAL~GUANFACINE HYDROCHLORIDE~MYLAN~EQ 2MG BASE~
A~074796~002~AB~Jan 27, 1997~No~RX~MYLAN PHARMACEUTICALS INC
GUANFACINE HYDROCHLORIDE~TABLET;ORAL~GUANFACINE HYDROCHLORIDE~WATSON LABS~EQ 1MG
BASE~A~074145~001~AB~Oct 17, 1995~No~RX~WATSON LABORATORIES INC
BASE~A~074145~002~AB~Oct 17, 1995~No~RX~WATSON LABORATORIES INC
GUANIDINE HYDROCHLORIDE~TABLET;ORAL~GUANIDINE HYDROCHLORIDE~MERCK SHARP DOHME~12
5MG~N~001546~001~~Approved Prior to Jan 1, 1982~No~RX~MERCK SHARP AND DOHME CORP
ESTRADIOL~TABLET;ORAL~GYNODIOL~DURAMED PHARMS BARR~0.5MG~A~040212~001~~Dec 29, 1
ESTRADIOL~TABLET;ORAL~GYNODIOL~DURAMED PHARMS BARR~1MG~A~040212~002~~Dec 29, 199
ESTRADIOL~TABLET;ORAL~GYNODIOL~DURAMED PHARMS BARR~1.5MG~A~040212~003~~Dec 29, 1
ESTRADIOL~TABLET;ORAL~GYNODIOL~DURAMED PHARMS BARR~2MG~A~040212~004~~Dec 29, 199
DYDROGESTERONE~TABLET;ORAL~GYNOREST~SOLVAY~5MG~N~017388~001~~Approved Prior to J
an 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
DYDROGESTERONE~TABLET;ORAL~GYNOREST~SOLVAY~10MG~N~017388~002~~Approved Prior to
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~H.R.-50~WHITEWORTH TOWN PLSN~50MG;0.1
25MG~A~085338~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULS
EN INC
TRIAZOLAM~TABLET;ORAL~HALCION~PHARMACIA AND UPJOHN~0.125MG~N~017892~003~AB~Apr 2
6, 1985~No~RX~PHARMACIA AND UPJOHN CO
TRIAZOLAM~TABLET;ORAL~HALCION~PHARMACIA AND UPJOHN~0.25MG~N~017892~001~AB~Nov 15
, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
TRIAZOLAM~TABLET;ORAL~HALCION~PHARMACIA AND UPJOHN~0.5MG~N~017892~002~~Nov 15, 1

HALOPERIDOL~TABLET;ORAL~HALDOL~ORTHO MCNEIL~0.5MG~N~015921~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL
HALOPERIDOL~TABLET;ORAL~HALDOL~ORTHO MCNEIL~1MG~N~015921~002~~Approved Prior to
Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL
HALOPERIDOL~TABLET;ORAL~HALDOL~ORTHO MCNEIL~20MG~N~015921~006~~Feb 2, 1982~No~DI
SCN~ORTHO MCNEIL PHARMACEUTICAL
HALOPERIDOL~TABLET;ORAL~HALDOL SOLUTAB~ORTHO MCNEIL PHARM~1MG~N~017079~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
PARAMETHASONE ACETATE~TABLET;ORAL~HALDRONE~LILLY~1MG~N~012772~005~~Approved Prio
PARAMETHASONE ACETATE~TABLET;ORAL~HALDRONE~LILLY~2MG~N~012772~006~~Approved Prio
HALOFANTRINE HYDROCHLORIDE~TABLET;ORAL~HALFAN~GLAXOSMITHKLINE~250MG~N~020250~001
~~Jul 24, 1992~No~DISCN~GLAXOSMITHKLINE
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~DURAMED PHARMS BARR~0.5MG~A~071216~001~~Dec
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~DURAMED PHARMS BARR~1MG~A~071217~001~~Dec 4,
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~DURAMED PHARMS BARR~10MG~A~071220~001~~Jul 7
, 1987~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~DURAMED PHARMS BARR~20MG~A~071221~001~~Jul 7
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~LEDERLE~0.5MG~A~072727~001~~Sep 19, 1989~No~
DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~LEDERLE~1MG~A~072728~001~~Sep 19, 1989~No~DI
SCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~LEDERLE~10MG~A~072731~001~~Sep 19, 1989~No~D
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~LEDERLE~20MG~A~072732~001~~Sep 19, 1989~No~D
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~MUTUAL PHARM~0.5MG~A~071156~001~~Jan 2, 1987
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~MUTUAL PHARM~1MG~A~071157~001~~Jan 2, 1987~N
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~MUTUAL PHARM~10MG~A~071173~001~~Jan 7, 1988~
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~MUTUAL PHARM~20MG~A~071177~001~~Jan 7, 1988~
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~MYLAN~0.5MG~A~070278~006~AB~Jun 10, 1986~No~
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~MYLAN~1MG~A~070278~004~AB~Jun 10, 1986~No~RX

HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~MYLAN~10MG~A~070278~002~AB~Jul 16, 2009~No~R
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~MYLAN~20MG~A~070278~003~AB~Jul 16, 2009~No~R
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~PAR PHARM~20MG~A~071328~001~~Jul 20, 1987~No
~DISCN~PAR PHARMACEUTICAL INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~PUREPAC PHARM~0.5MG~A~071071~001~~Nov 3, 198
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~PUREPAC PHARM~1MG~A~071072~001~~Nov 3, 1986~
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~PUREPAC PHARM~10MG~A~071075~001~~Aug 4, 1987
~No~DISCN~PUREPAC PHARMACEUTICAL CO
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~PUREPAC PHARM~20MG~A~071076~001~~Aug 4, 1987
~No~DISCN~PUREPAC PHARMACEUTICAL CO
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~QUANTUM PHARMICS~0.5MG~A~071255~001~~Feb 17,
1987~No~DISCN~QUANTUM PHARMICS LTD
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~QUANTUM PHARMICS~1MG~A~071269~001~~Feb 17, 1
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ROXANE~0.5MG~A~071128~001~~Feb 17, 1987~No~D
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ROXANE~1MG~A~071129~001~~Feb 17, 1987~No~DIS
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ROXANE~10MG~A~071132~001~~May 12, 1987~No~DI
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ROXANE~20MG~A~071133~001~~May 12, 1987~No~DI
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ROYCE LABS~0.5MG~A~071722~001~~Dec 24, 1987~
No~DISCN~ROYCE LABORATORIES INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ROYCE LABS~1MG~A~071723~001~~Dec 24, 1987~No
~DISCN~ROYCE LABORATORIES INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ROYCE LABS~10MG~A~072121~001~~Dec 24, 1987~N
o~DISCN~ROYCE LABORATORIES INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ROYCE LABS~20MG~A~072122~001~~Dec 24, 1987~N
o~DISCN~ROYCE LABORATORIES INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SANDOZ~0.5MG~A~071206~001~AB~Nov 17, 1986~No
~RX~SANDOZ INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SANDOZ~1MG~A~071207~001~AB~Nov 17, 1986~No~R
X~SANDOZ INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SANDOZ~2MG~A~071208~001~AB~Nov 17, 1986~Yes~

RX~SANDOZ INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SANDOZ~5MG~A~071209~001~AB~Nov 17, 1986~No~R
X~SANDOZ INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SANDOZ~10MG~A~071210~001~AB~Mar 11, 1988~No~
RX~SANDOZ INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SANDOZ~20MG~A~071211~001~AB~Mar 11, 1988~No~
RX~SANDOZ INC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SCS~0.5MG~A~070720~001~~Jun 10, 1986~No~DISC
N~SCS PHARMACEUTICALS
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SCS~1MG~A~070721~001~~Jun 10, 1986~No~DISCN~
SCS PHARMACEUTICALS
SCS PHARMACEUTICALS
SCS PHARMACEUTICALS
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SCS~10MG~A~070724~001~~Jun 10, 1986~No~DISCN
~SCS PHARMACEUTICALS
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~SCS~20MG~A~070725~001~~Sep 24, 1986~No~DISCN
~SCS PHARMACEUTICALS
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~VINTAGE~0.5MG~A~071233~001~~Nov 3, 1986~No~D
ISCN~VINTAGE PHARMACEUTICALS LLC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~VINTAGE~1MG~A~071234~001~~Nov 3, 1986~No~DIS
CN~VINTAGE PHARMACEUTICALS LLC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~VINTAGE~10MG~A~071237~001~~Jul 20, 1987~No~D
ISCN~VINTAGE PHARMACEUTICALS LLC
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~WATSON LABS~0.5MG~A~070981~001~~Mar 6, 1987~
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~WATSON LABS~0.5MG~A~071571~001~~Jun 3, 1988~
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~WATSON LABS~1MG~A~070982~001~~Mar 6, 1987~No
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~WATSON LABS~1MG~A~071572~001~~Jun 3, 1988~No
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~WATSON LABS~10MG~A~071375~001~~Jun 3, 1988~N
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~WATSON LABS~10MG~A~072113~001~~Aug 27, 1991~
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~WATSON LABS~20MG~A~071376~001~~Jun 3, 1988~N
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~WATSON LABS~20MG~A~072353~001~~Aug 27, 1991~
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ZYDUS PHARMS USA~5MG~A~077580~003~AB~Nov 29,
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ZYDUS PHARMS USA~10MG~A~077580~004~AB~Nov 29
HALOPERIDOL~TABLET;ORAL~HALOPERIDOL~ZYDUS PHARMS USA~20MG~A~077580~005~AB~Nov 29
FLUOXYMESTERONE~TABLET;ORAL~HALOTESTIN~PHARMACIA AND UPJOHN~2MG~N~010611~002~~Ap

proved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
FLUOXYMESTERONE~TABLET;ORAL~HALOTESTIN~PHARMACIA AND UPJOHN~5MG~N~010611~006~~Ap
FLUOXYMESTERONE~TABLET;ORAL~HALOTESTIN~PHARMACIA AND UPJOHN~10MG~N~010611~010~~A
pproved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
DESERPIDINE~TABLET;ORAL~HARMONYL~ABBVIE~0.1MG~N~010796~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~ABBVIE INC
DESERPIDINE~TABLET;ORAL~HARMONYL~ABBVIE~0.25MG~N~010796~002~~Approved Prior to J
an 1, 1982~No~DISCN~ABBVIE INC
LEDIPASVIR; SOFOSBUVIR~TABLET;ORAL~HARVONI~GILEAD SCIENCES INC~90MG;400MG~N~2058
34~001~~Oct 10, 2014~Yes~RX~GILEAD SCIENCES INC
PHENINDIONE~TABLET;ORAL~HEDULIN~SANOFI AVENTIS US~50MG~N~008767~002~~Approved Pr
ADEFOVIR DIPIVOXIL~TABLET;ORAL~HEPSERA~GILEAD~10MG~N~021449~001~AB~Sep 20, 2002~
Yes~RX~GILEAD SCIENCES INC
DIETHYLCARBAMAZINE CITRATE~TABLET;ORAL~HETRAZAN~LEDERLE~50MG~N~006459~001~~Appro
DEXAMETHASONE~TABLET;ORAL~HEXADROL~ORGANON USA INC~0.5MG~N~012675~004~~Approved
DEXAMETHASONE~TABLET;ORAL~HEXADROL~ORGANON USA INC~4MG~N~012675~010~~Approved Pr
ior to Jan 1, 1982~No~DISCN~ORGANON USA INC
METHENAMINE HIPPURATE~TABLET;ORAL~HIPREX~SANOFI AVENTIS US~1GM~N~017681~001~AB~A
pproved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
RESERPINE~TABLET;ORAL~HISERPIA~BOWMAN PHARMS~0.1MG~N~009631~002~~Approved Prior
to Jan 1, 1982~No~DISCN~BOWMAN PHARMACEUTICALS INC
RESERPINE~TABLET;ORAL~HISERPIA~BOWMAN PHARMS~0.25MG~N~009631~004~~Approved Prior
to Jan 1, 1982~No~DISCN~BOWMAN PHARMACEUTICALS INC
ZALCITABINE~TABLET;ORAL~HIVID~ROCHE~0.375MG~N~020199~001~~Jun 19, 1992~No~DISCN~
ZALCITABINE~TABLET;ORAL~HIVID~ROCHE~0.75MG~N~020199~002~~Jun 19, 1992~No~DISCN~H
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~HIWOLFIA~BOWMAN PHARMS~50MG~N~009276~003~~
Approved Prior to Jan 1, 1982~No~DISCN~BOWMAN PHARMACEUTICALS INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~HIWOLFIA~BOWMAN PHARMS~50MG~N~009276~005~~
Approved Prior to Jan 1, 1982~No~DISCN~BOWMAN PHARMACEUTICALS INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~HIWOLFIA~BOWMAN PHARMS~100MG~N~009276~004~
~Approved Prior to Jan 1, 1982~No~DISCN~BOWMAN PHARMACEUTICALS INC
HOMATROPINE METHYLBROMIDE~TABLET;ORAL~HOMAPIN-10~MISSION PHARMA~10MG~A~086308~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~MISSION PHARMACAL CO
HOMATROPINE METHYLBROMIDE~TABLET;ORAL~HOMAPIN-5~MISSION PHARMA~5MG~A~086309~001~
~Approved Prior to Jan 1, 1982~No~DISCN~MISSION PHARMACAL CO
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE~TABLET;ORAL~HOMATROPINE METHYL
BROMIDE AND HYDROCODONE BITARTRATE~NOVEL LABS INC~1.5MG;5MG~A~091528~001~AA~Apr
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE~TABLET;ORAL~HOMATROPRINE METHY
LBROMIDE AND HYDROCODONE BITARTRATE~ACTAVIS ELIZABETH~1.5MG;5MG~A~040295~001~~De
c 1, 2000~No~DISCN~ACTAVIS ELIZABETH LLC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~HY-PHEN~ASCHER~500MG;5MG~A~087
677~001~~May 3, 1982~No~DISCN~BF ASCHER AND CO INC
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE~TABLET;ORAL~HYCODAN~ENDO PHARM
S~1.5MG;5MG~N~005213~001~~Jul 26, 1988~No~DISCN~ENDO PHARMACEUTICALS INC
ERGOLOID MESYLATES~TABLET;ORAL~HYDERGINE~NOVARTIS~0.5MG~N~017993~003~~Approved P
rior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
ERGOLOID MESYLATES~TABLET;ORAL~HYDERGINE~NOVARTIS~1MG~N~017993~001~AB~Approved P
rior to Jan 1, 1982~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDRALAZINE AND HYDRO

CHLORTHIAZIDE~WATSON LABS~25MG;15MG~A~085827~001~~Approved Prior to Jan 1, 1982~
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~ACTAVIS ELIZABET
H~25MG~A~088560~001~~Oct 4, 1984~No~DISCN~ACTAVIS ELIZABETH LLC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~ACTAVIS ELIZABET
H~50MG~A~088649~001~~Oct 18, 1984~No~DISCN~ACTAVIS ELIZABETH LLC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~ACTAVIS GRP PTC~
10MG~A~091679~001~AA~Mar 4, 2013~No~RX~ACTAVIS GROUP PTC EHF
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~ALKEM LABS LTD~1
0MG~A~200737~001~AA~Dec 7, 2012~No~RX~ALKEM LABORATORIES LTD
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~ASCOT~25MG~A~088
310~001~~Dec 19, 1984~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABOR
ATORIES INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~ASCOT~50MG~A~088
311~001~~Dec 19, 1984~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABOR
ATORIES INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~CADILA PHARMS LT
D~25MG~A~203845~001~AA~Sep 18, 2014~No~RX~CADILA PHARMACEUTICALS LTD
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~GLENMARK PHARMS
LTD~10MG~A~090527~001~AA~May 27, 2009~No~RX~GLENMARK PHARMACEUTICALS LTD
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~HALSEY~10MG~A~08
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~HERITAGE PHARMS
INC~10MG~A~086242~001~AA~Feb 4, 2010~No~RX~HERITAGE PHARMACEUTICALS INC
INC~25MG~A~086242~003~AA~Approved Prior to Jan 1, 1982~No~RX~HERITAGE PHARMACEUT
ICALS INC
INC~50MG~A~086242~002~AA~Approved Prior to Jan 1, 1982~No~RX~HERITAGE PHARMACEUT
ICALS INC
INC~100MG~A~086242~004~AA~Feb 4, 2010~No~RX~HERITAGE PHARMACEUTICALS INC

HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~HETERO LABS LTD
III~10MG~A~040901~001~AA~Sep 12, 2008~No~RX~HETERO LABS LTD UNIT III
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~IMPAX LABS~25MG~
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~IMPAX LABS~50MG~
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~INVAGEN PHARMS~1
0MG~A~090255~001~AA~Dec 15, 2008~No~RX~INVAGEN PHARMACEUTICALS INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~IVAX SUB TEVA PH
ARMS~10MG~A~084443~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTIC
ALS INC SUB TEVA PHARMACEUTICALS USA
ARMS~100MG~A~084581~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTI
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~MUTUAL PHARM~10M
G~A~088728~001~~Apr 11, 1985~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
G~A~089359~001~~Jul 25, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
G~A~084106~002~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO
INC
G~A~089258~001~~May 5, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
G~A~084107~002~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO
INC
G~A~089259~001~~May 5, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~MUTUAL PHARM~100
MG~A~088729~001~~Apr 11, 1985~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~MYLAN~10MG~A~090
413~001~AA~Dec 8, 2010~No~RX~MYLAN PHARMACEUTICALS INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~PAR PHARM~10MG~A
~087836~001~AA~Oct 5, 1982~No~RX~PAR PHARMACEUTICAL INC
~086961~002~AA~Approved Prior to Jan 1, 1982~No~RX~PAR PHARMACEUTICAL INC

~086962~001~AA~Approved Prior to Jan 1, 1982~No~RX~PAR PHARMACEUTICAL INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~PAR PHARM~100MG~
A~088391~001~AA~Sep 27, 1983~No~RX~PAR PHARMACEUTICAL INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~PLIVA~10MG~A~089
097~001~AA~Dec 18, 1985~Yes~RX~PLIVA INC
467~001~AA~May 1, 1984~Yes~RX~PLIVA INC
468~001~AA~May 1, 1984~Yes~RX~PLIVA INC
9098~001~AA~Dec 18, 1985~Yes~RX~PLIVA INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~PUREPAC PHARM~25
MG~A~088177~001~~Jul 29, 1983~No~DISCN~PUREPAC PHARMACEUTICAL CO
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~PUREPAC PHARM~50
MG~A~088178~001~~Aug 15, 1983~No~DISCN~PUREPAC PHARMACEUTICAL CO
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~QUANTUM PHARMICS
~10MG~A~088671~001~~May 1, 1984~No~DISCN~QUANTUM PHARMICS LTD
~25MG~A~088657~001~~Jun 15, 1984~No~DISCN~QUANTUM PHARMICS LTD
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~SANDOZ~10MG~A~08
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~STRIDES PHARMA~2
5MG~A~200770~001~AA~May 3, 2013~No~RX~STRIDES PHARMA GLOBAL PTE LTD
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~SUPERPHARM~10MG~
A~088787~001~~Aug 28, 1984~No~DISCN~SUPERPHARM CORP
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~TG UNITED LABS~1
0MG~A~088846~001~~Feb 26, 1985~No~DISCN~TG UNITED LABS LLC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~USL PHARMA~25MG~
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~USL PHARMA~50MG~
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~VANGARD~25MG~A~0
87712~001~~Approved Prior to Jan 1, 1982~No~DISCN~VANGARD LABORATORIES INC DIV M
IDWAY MEDICAL CO
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~VANGARD~50MG~A~0

87908~001~~May 7, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~VITARINE~25MG~A~
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~WATSON LABS~25MG
~A~084504~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
~A~085532~002~~May 24, 1982~No~DISCN~WATSON LABORATORIES INC
~A~085533~002~~May 25, 1982~No~DISCN~WATSON LABORATORIES INC
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~WEST WARD~25MG~A
~088240~001~~May 27, 1983~No~DISCN~WEST WARD PHARMACEUTICAL CORP
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~WEST WARD~50MG~A
~088241~001~~May 27, 1983~No~DISCN~WEST WARD PHARMACEUTICAL CORP
HYDRALAZINE HYDROCHLORIDE~TABLET;ORAL~HYDRALAZINE HYDROCHLORIDE~ZYDUS PHARMS USA
~10MG~A~040858~001~~Feb 26, 2010~No~DISCN~ZYDUS PHARMACEUTICALS USA INC
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDRALAZIN
E HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE~IVAX SUB TEVA PHARMS~25MG;15M
G;0.1MG~A~084291~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICAL
S INC SUB TEVA PHARMACEUTICALS USA
E HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE~MYLAN~25MG;15MG;0.1MG~A~087085~001
~~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
E, HYDROCHLOROTHIAZIDE W/ RESERPINE~WATSON LABS~25MG;15MG;0.1MG~A~085771~001~~Ap
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDRAP-ES~
SANDOZ~25MG;15MG;0.1MG~A~084876~001~~Approved Prior to Jan 1, 1982~No~DISCN~SAND
OZ INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDRO-D~HALSEY~25MG~A~086504~001~~Approved Prior
to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDRO-D~HALSEY~50MG~A~083891~002~~Approved Prior
to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDRO-RESERP~ABC HOLDING~50MG;0.125MG
~A~084714~002~~Jun 29, 1982~No~DISCN~ABC HOLDING CORP
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDRO-RIDE~PAR PHARM~EQ
5MG ANHYDROUS;50MG~A~070347~001~~Dec 25, 1990~No~DISCN~PAR PHARMACEUTICAL INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~"HYDRO-SERP ""25"""~SANDOZ~25MG;0.125
MG~A~084827~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~"HYDRO-SERP ""50"""~SANDOZ~50MG;0.125
MG~A~085213~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ABC HOLDING~50MG~A~085672~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~ABC HOLDING CORP
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ACCORD HLTHCARE~12.5MG~A~202
556~001~AB~Sep 24, 2012~No~RX~ACCORD HEALTHCARE INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ACCORD HLTHCARE~25MG~A~20255
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ACCORD HLTHCARE~50MG~A~20255
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ACTAVIS ELIZABETH~12.5MG~A~0
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ACTAVIS ELIZABETH~25MG~A~085
054~002~~Approved Prior to Jan 1, 1982~No~DISCN~ACTAVIS ELIZABETH LLC

HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ACTAVIS ELIZABETH~50MG~A~085
208~001~~Approved Prior to Jan 1, 1982~No~DISCN~ACTAVIS ELIZABETH LLC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ALRA~25MG~A~086369~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ALRA~50MG~A~083554~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~APOTEX~25MG~A~040774~001~AB~
Oct 3, 2007~No~RX~APOTEX INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~APOTEX~50MG~A~040774~002~AB~
Oct 3, 2007~No~RX~APOTEX INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ASCOT~25MG~A~087539~001~~Feb
3, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ASCOT~50MG~A~087540~001~~Feb
3, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~AUROBINDO PHARMA~25MG~A~0407
80~001~AB~Jul 20, 2007~No~RX~AUROBINDO PHARMA LTD
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~AUROBINDO PHARMA~50MG~A~0407
80~002~AB~Jul 20, 2007~No~RX~AUROBINDO PHARMA LTD
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~BARR~50MG~A~084771~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~DAVA PHARMS INC~25MG~A~08705
9~001~AB~Approved Prior to Jan 1, 1982~No~RX~DAVA PHARMACEUTICALS INC
8~001~AB~Approved Prior to Jan 1, 1982~No~RX~DAVA PHARMACEUTICALS INC
60~001~~Approved Prior to Jan 1, 1982~No~DISCN~DAVA PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ELKINS SINN~50MG~A~085152~00
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~EXCELLIUM~25MG~A~040702~001~
AB~Mar 16, 2007~No~RX~EXCELLIUM PHARMACEUTICAL INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~EXCELLIUM~50MG~A~040702~002~
AB~Mar 16, 2007~No~RX~EXCELLIUM PHARMACEUTICAL INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~HEATHER~50MG~A~084135~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~HERITAGE PHARMS INC~25MG~A~0
85182~002~AB~Approved Prior to Jan 1, 1982~No~RX~HERITAGE PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~HERITAGE PHARMS INC~50MG~A~0
85182~001~AB~Approved Prior to Jan 1, 1982~No~RX~HERITAGE PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~HIKMA PHARMS LLC~25MG~A~0848
78~002~~Jul 12, 2006~No~DISCN~HIKMA PHARMACEUTICALS LLC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~HIKMA PHARMS LLC~50MG~A~0848
78~001~AB~Approved Prior to Jan 1, 1982~No~RX~HIKMA PHARMACEUTICALS LLC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~IMPAX LABS~25MG~A~084029~001
~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
1~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~INWOOD LABS~25MG~A~084776~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LAB
ORATORIES INC
ORATORIES INC
ORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~IPCA LABS LTD~12.5MG~A~04080
7~001~AB~Jul 20, 2007~No~RX~IPCA LABORATORIES LTD
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~IPCA LABS LTD~25MG~A~040807~

002~AB~Jul 20, 2007~No~RX~IPCA LABORATORIES LTD
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~IPCA LABS LTD~50MG~A~040807~
003~AB~Jul 20, 2007~No~RX~IPCA LABORATORIES LTD
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~25MG~A~
083177~001~AB~Approved Prior to Jan 1, 1982~No~RX~IVAX PHARMACEUTICALS INC SUB T
083177~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~IVAX PHARMACEUTICALS INC SUB
084658~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~100MG~A
~085022~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~JUBILANT CADISTA~25MG~A~0408
09~001~AB~Sep 4, 2007~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~JUBILANT CADISTA~50MG~A~0408
09~002~AB~Sep 4, 2007~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~LANNETT~25MG~A~084325~001~AB
~Approved Prior to Jan 1, 1982~No~RX~LANNETT HOLDINGS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~LANNETT~50MG~A~084324~001~AB
~Approved Prior to Jan 1, 1982~No~RX~LANNETT HOLDINGS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MAST MM~25MG~A~086192~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~MM MAST AND CO
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MAST MM~50MG~A~086192~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~MM MAST AND CO
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MUTUAL PHARM~25MG~A~083972~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MUTUAL PHARM~50MG~A~083972~0
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MUTUAL PHARM~100MG~A~083972~
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MYLAN~25MG~A~084880~001~~App
roved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MYLAN~50MG~A~085112~001~~App
roved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MYLAN PHARMS INC~12.5MG~A~04
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MYLAN PHARMS INC~25MG~A~0407
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~MYLAN PHARMS INC~50MG~A~0407
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~PVT FORM~50MG~A~086597~001~~
Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~ROXANE~25MG~A~085004~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SANDOZ~25MG~A~083899~001~~Ap
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SANDOZ~25MG~A~087565~001~~Ma
r 9, 1982~No~DISCN~SANDOZ INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SCIEGEN PHARMS INC~25MG~A~20

3018~001~AB~Jul 23, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SCIEGEN PHARMS INC~50MG~A~20
3018~002~AB~Jul 23, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SOLVAY~25MG~A~085323~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SUN PHARM INDS INC~12.5MG~A~
040857~001~AB~May 30, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SUN PHARM INDS INC~25MG~A~04
0810~001~AB~Mar 27, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SUN PHARM INDS INC~50MG~A~04
0810~002~AB~Mar 27, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~SUPERPHARM~25MG~A~088827~001
~~Dec 28, 1984~No~DISCN~SUPERPHARM CORP
~~Dec 28, 1984~No~DISCN~SUPERPHARM CORP
1~~Dec 28, 1984~No~DISCN~SUPERPHARM CORP
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~TEVA~25MG~A~088924~001~~Feb
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~TEVA~50MG~A~088923~001~~Feb
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~TG UNITED LABS~25MG~A~085683
~001~~Approved Prior to Jan 1, 1982~No~DISCN~TG UNITED LABS LLC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~TG UNITED LABS~50MG~A~083965
~001~~Approved Prior to Jan 1, 1982~No~DISCN~TG UNITED LABS LLC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~UNICHEM~25MG~A~040907~001~AB
~Aug 15, 2008~No~RX~UNICHEM LABORATORIES LTD
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~UNICHEM~50MG~A~040907~002~AB
~Aug 15, 2008~No~RX~UNICHEM LABORATORIES LTD
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~USL PHARMA~25MG~A~087827~001
~~Apr 19, 1982~No~DISCN~USL PHARMA INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~USL PHARMA~50MG~A~087752~001
~~Apr 19, 1982~No~DISCN~USL PHARMA INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~VANGARD~25MG~A~087638~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICA
L CO
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~VANGARD~50MG~A~087610~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICA
L CO
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~VINTAGE PHARMS~25MG~A~040412
~001~AB~Mar 29, 2002~No~RX~VINTAGE PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~VINTAGE PHARMS~50MG~A~040412
~002~AB~Mar 29, 2002~No~RX~VINTAGE PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~WARNER CHILCOTT~25MG~A~08758
6~001~~May 3, 1982~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~WARNER CHILCOTT~50MG~A~08758
7~001~~May 3, 1982~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~WATSON LABS~25MG~A~081189~00
1~~Jan 24, 1992~No~DISCN~WATSON LABORATORIES INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~WEST WARD~25MG~A~084899~001~
~Approved Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~WHITEWORTH TOWN PLSN~25MG~A~
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~WHITEWORTH TOWN PLSN~50MG~A~
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE~WHITEWORTH TOWN PLSN~100MG~A
~085347~001~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDROCHLOROTHIAZIDE W
/ HYDRALAZINE~WATSON LABS~25MG;15MG~A~085373~001~~Approved Prior to Jan 1, 1982~
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROCHLOROTHIAZIDE W/ RESERPINE~IVAX
SUB TEVA PHARMS~25MG;0.1MG~A~083572~001~~Approved Prior to Jan 1, 1982~No~DISCN
SUB TEVA PHARMS~25MG;0.125MG~A~083571~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
SUB TEVA PHARMS~50MG;0.1MG~A~083568~001~~Approved Prior to Jan 1, 1982~No~DISCN
SUB TEVA PHARMS~50MG;0.125MG~A~083573~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROCHLOROTHIAZIDE W/ RESERPINE~PHAR
MERAL~25MG;0.125MG~A~085421~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMERA
L INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROCHLOROTHIAZIDE W/ RESERPINE~PHAR
MERAL~50MG;0.125MG~A~085420~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMERA
L INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROCHLOROTHIAZIDE W/ RESERPINE~ROXA
NE~50MG;0.125MG~A~084603~001~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABO
RATORIES INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROCHLOROTHIAZIDE W/ RESERPINE~WATS
ON LABS~25MG;0.125MG~A~084466~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON
LABORATORIES INC
LABORATORIES INC
LABORATORIES INC
LABORATORIES INC
LABORATORIES INC
LABORATORIES INC
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROCHLOR

OTHIAZIDE W/ RESERPINE AND HYDRALAZINE~WATSON LABS~25MG;15MG;0.1MG~A~083770~001~
~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~HYDROCODONE BITARTRATE AND ACE
TAMINOPHEN~ABLE~325MG;5MG~A~040478~001~~Nov 8, 2002~No~DISCN~ABLE LABORATORIES I
NC
TAMINOPHEN~ABLE~325MG;7.5MG~A~040464~001~~Oct 23, 2002~No~DISCN~ABLE LABORATORIE
S INC
TAMINOPHEN~ABLE~325MG;10MG~A~040464~002~~Oct 23, 2002~No~DISCN~ABLE LABORATORIES
INC
TAMINOPHEN~ABLE~500MG;5MG~A~040477~001~~Nov 6, 2002~No~DISCN~ABLE LABORATORIES I
NC
TAMINOPHEN~ABLE~500MG;7.5MG~A~040490~001~~May 21, 2003~No~DISCN~ABLE LABORATORIE
S INC
TAMINOPHEN~ABLE~500MG;10MG~A~040473~001~~Nov 6, 2002~No~DISCN~ABLE LABORATORIES
INC
TAMINOPHEN~ABLE~650MG;7.5MG~A~040474~001~~Jan 2, 2003~No~DISCN~ABLE LABORATORIES
INC
TAMINOPHEN~ABLE~650MG;10MG~A~040476~001~~Oct 23, 2002~No~DISCN~ABLE LABORATORIES
INC
TAMINOPHEN~ABLE~750MG;7.5MG~A~040469~001~~Oct 25, 2002~No~DISCN~ABLE LABORATORIE
S INC
TAMINOPHEN~ACTAVIS LABS FL INC~500MG;10MG~A~040148~002~~Feb 14, 1997~No~DISCN~AC
TAVIS LABORATORIES FL INC
TAMINOPHEN~AMNEAL PHARMS NY~325MG;5MG~A~040736~001~AA~Aug 25, 2006~No~RX~AMNEAL
PHARMACEUTICALS NY LLC
TAMINOPHEN~AMNEAL PHARMS NY~325MG;10MG~A~040746~001~AA~Aug 25, 2006~No~RX~AMNEAL
TAMINOPHEN~AMNEAL PHARMS NY~500MG;5MG~A~040729~001~~Aug 25, 2006~No~DISCN~AMNEAL
TAMINOPHEN~AMNEAL PHARMS NY~500MG;7.5MG~A~040748~001~~Aug 25, 2006~No~DISCN~AMNE
AL PHARMACEUTICALS NY LLC
TAMINOPHEN~AMNEAL PHARMS NY~500MG;10MG~A~040813~001~~Feb 23, 2007~No~DISCN~AMNEA
L PHARMACEUTICALS NY LLC
TAMINOPHEN~AMNEAL PHARMS NY~650MG;10MG~A~040757~001~~Aug 25, 2006~No~DISCN~AMNEA
L PHARMACEUTICALS NY LLC
TAMINOPHEN~AUROLIFE PHARMA LLC~325MG;5MG~A~201013~001~AA~Apr 11, 2012~No~RX~AURO
LIFE PHARMA LLC

TAMINOPHEN~AUROLIFE PHARMA LLC~325MG;7.5MG~A~201013~002~AA~Apr 11, 2012~No~RX~AU
ROLIFE PHARMA LLC
TAMINOPHEN~AUROLIFE PHARMA LLC~325MG;10MG~A~201013~003~AA~Apr 11, 2012~No~RX~AUR
OLIFE PHARMA LLC
TAMINOPHEN~BARR~500MG;2.5MG~A~040307~001~~Jul 26, 2000~No~DISCN~BARR LABORATORIE
S INC
TAMINOPHEN~BARR~500MG;5MG~A~040308~001~~Jul 26, 2000~No~DISCN~BARR LABORATORIES
INC
TAMINOPHEN~BARR~500MG;5MG~A~088577~001~~Dec 21, 1984~No~DISCN~BARR LABORATORIES
INC
S INC
INC
S INC
INC
S INC
TAMINOPHEN~CARACO~500MG;5MG~A~090265~001~~Dec 23, 2008~No~DISCN~CARACO PHARMACEU
TICAL LABORATORIES LTD
TAMINOPHEN~CARACO~500MG;7.5MG~A~090265~002~~Dec 23, 2008~No~DISCN~CARACO PHARMAC
EUTICAL LABORATORIES LTD
TAMINOPHEN~CARACO~500MG;10MG~A~090265~003~~Dec 23, 2008~No~DISCN~CARACO PHARMACE
UTICAL LABORATORIES LTD
TAMINOPHEN~HALSEY~500MG;5MG~A~089554~001~~Jun 12, 1987~No~DISCN~HALSEY DRUG CO I
NC
TAMINOPHEN~IVAX PHARMS~500MG;5MG~A~089696~001~~Apr 21, 1988~No~DISCN~IVAX PHARMA
CEUTICALS INC
TAMINOPHEN~MALLINCKRODT~325MG;10MG~A~040400~001~AA~Jul 26, 2000~No~RX~MALLINCKRO
DT INC

TAMINOPHEN~MALLINCKRODT~500MG;5MG~A~040084~002~~Jun 1, 1995~No~DISCN~MALLINCKROD
T CHEMICAL INC
TAMINOPHEN~MALLINCKRODT~500MG;7.5MG~A~040201~001~~Feb 27, 1998~No~DISCN~MALLINCK
RODT CHEMICAL INC
TAMINOPHEN~MALLINCKRODT~500MG;10MG~A~040201~002~~Feb 27, 1998~No~DISCN~MALLINCKR
ODT CHEMICAL INC
TAMINOPHEN~MALLINCKRODT~650MG;10MG~A~040084~004~~Oct 16, 1996~No~DISCN~MALLINCKR
ODT CHEMICAL INC
TAMINOPHEN~MALLINCKRODT~660MG;10MG~A~040084~003~~Jul 29, 1996~No~DISCN~MALLINCKR
ODT CHEMICAL INC
TAMINOPHEN~MALLINCKRODT~750MG;7.5MG~A~040084~001~~Jun 1, 1995~No~DISCN~MALLINCKR
ODT CHEMICAL INC
TAMINOPHEN~MIKART~300MG;5MG~A~040658~001~AA~Jan 19, 2006~Yes~RX~MIKART INC
TAMINOPHEN~MIKART~300MG;7.5MG~A~040556~002~AA~Mar 24, 2006~Yes~RX~MIKART INC
TAMINOPHEN~MIKART~300MG;10MG~A~040556~001~AA~Jun 23, 2004~Yes~RX~MIKART INC
TAMINOPHEN~MIKART~325MG;2.5MG~A~040846~001~AA~Jun 9, 2010~Yes~RX~MIKART INC
TAMINOPHEN~MIKART~325MG;7.5MG~A~040432~001~AA~Jan 22, 2003~No~RX~MIKART INC
TAMINOPHEN~MIKART~500MG;2.5MG~A~089698~001~~Aug 25, 1989~No~DISCN~MIKART INC
TAMINOPHEN~MIKART~500MG;5MG~A~089271~001~~Jul 16, 1986~No~DISCN~MIKART INC
TAMINOPHEN~MIKART~500MG;5MG~A~089697~001~~Jan 28, 1992~No~DISCN~MIKART INC
TAMINOPHEN~MIKART~500MG;7.5MG~A~089699~001~~Aug 25, 1989~No~DISCN~MIKART INC
TAMINOPHEN~MIKART~650MG;5MG~A~040849~001~~Jun 9, 2010~No~DISCN~MIKART INC
TAMINOPHEN~MIKART~650MG;7.5MG~A~089689~001~~Jun 29, 1988~No~DISCN~MIKART INC
TAMINOPHEN~MIKART~650MG;10MG~A~081223~001~~May 29, 1992~No~DISCN~MIKART INC
TAMINOPHEN~MUTUAL PHARM~500MG;5MG~A~040236~001~~Sep 25, 1997~No~DISCN~MUTUAL PHA
RMACEUTICAL CO INC
TAMINOPHEN~MUTUAL PHARM~650MG;7.5MG~A~040240~002~~Nov 26, 1997~No~DISCN~MUTUAL P
TAMINOPHEN~MUTUAL PHARM~650MG;10MG~A~040240~001~~Nov 26, 1997~No~DISCN~MUTUAL PH
ARMACEUTICAL CO INC
TAMINOPHEN~MUTUAL PHARM~750MG;7.5MG~A~040236~002~~Sep 25, 1997~No~DISCN~MUTUAL P
TAMINOPHEN~RANBAXY~500MG;5MG~A~040825~001~~Aug 16, 2007~No~DISCN~RANBAXY INC
TAMINOPHEN~RANBAXY~500MG;10MG~A~040824~001~~Aug 16, 2007~No~DISCN~RANBAXY LABORA
TORIES INC
TAMINOPHEN~RANBAXY LABS LTD~325MG;10MG~A~040826~001~~Aug 16, 2007~No~DISCN~RANBA

XY LABORATORIES LTD
TAMINOPHEN~RANBAXY LABS LTD~750MG;7.5MG~A~040822~001~~Aug 16, 2007~No~DISCN~RANB
AXY LABORATORIES LTD
TAMINOPHEN~SANDOZ~500MG;5MG~A~040149~001~~Jan 27, 1997~No~DISCN~SANDOZ INC
TAMINOPHEN~SANDOZ~750MG;7.5MG~A~040149~002~~Jan 27, 1997~No~DISCN~SANDOZ INC
TAMINOPHEN~SUN PHARM INDS INC~325MG;5MG~A~090118~001~AA~Dec 23, 2008~No~RX~SUN P
HARMACEUTICAL INDUSTRIES INC
TAMINOPHEN~SUN PHARM INDS INC~325MG;7.5MG~A~090118~002~AA~Dec 23, 2008~No~RX~SUN
PHARMACEUTICAL INDUSTRIES INC
TAMINOPHEN~SUN PHARM INDS INC~325MG;10MG~A~090118~003~AA~Dec 23, 2008~No~RX~SUN
PHARMACEUTICAL INDUSTRIES INC
TAMINOPHEN~TRIS PHARMA INC~325MG;5MG~A~202214~001~AA~Mar 27, 2013~No~RX~TRIS PHA
RMA INC
TAMINOPHEN~TRIS PHARMA INC~325MG;7.5MG~A~202214~002~AA~Mar 27, 2013~No~RX~TRIS P
HARMA INC
TAMINOPHEN~TRIS PHARMA INC~325MG;10MG~A~202214~003~AA~Mar 27, 2013~No~RX~TRIS PH
ARMA INC
TAMINOPHEN~UCB INC~500MG;10MG~A~040210~001~~Aug 13, 1997~No~DISCN~UCB INC
TAMINOPHEN~UCB INC~650MG;7.5MG~A~040134~001~~Nov 21, 1996~No~DISCN~UCB INC
TAMINOPHEN~USL PHARMA~500MG;5MG~A~089290~001~~May 29, 1987~No~DISCN~USL PHARMA I
NC
TAMINOPHEN~USL PHARMA~500MG;5MG~A~089291~001~~May 29, 1987~No~DISCN~USL PHARMA I
NC
TAMINOPHEN~VINTAGE PHARMS~300MG;5MG~A~090415~001~AA~Jan 24, 2011~No~RX~VINTAGE P
HARMACEUTICALS
TAMINOPHEN~VINTAGE PHARMS~300MG;7.5MG~A~090415~002~AA~Jan 24, 2011~No~RX~VINTAGE
PHARMACEUTICALS
TAMINOPHEN~VINTAGE PHARMS~300MG;10MG~A~090415~003~AA~Jan 24, 2011~No~RX~VINTAGE
PHARMACEUTICALS
TAMINOPHEN~VINTAGE PHARMS~325MG;5MG~A~040655~001~AA~Jan 19, 2006~No~RX~VINTAGE P
HARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS~325MG;7.5MG~A~040656~001~AA~Jan 19, 2006~No~RX~VINTAGE
PHARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS~325MG;10MG~A~040355~001~AA~May 31, 2000~No~RX~VINTAGE
PHARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS~500MG;2.5MG~A~040144~002~~Apr 25, 1997~No~DISCN~VINTAG
TAMINOPHEN~VINTAGE PHARMS~500MG;5MG~A~089831~001~~Sep 7, 1988~No~DISCN~VINTAGE P
HARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS~500MG;5MG~A~089971~001~~Dec 2, 1988~No~DISCN~VINTAGE P
HARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS~500MG;7.5MG~A~040144~001~~Feb 22, 1996~No~DISCN~VINTAG
TAMINOPHEN~VINTAGE PHARMS~500MG;10MG~A~040356~001~~May 31, 2000~No~DISCN~VINTAGE
PHARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS~650MG;10MG~A~040143~001~~Feb 22, 1996~No~DISCN~VINTAGE
PHARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS~660MG;10MG~A~040358~001~~May 31, 2000~No~DISCN~VINTAGE
PHARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS LLC~500MG;5MG~A~040281~001~~Sep 30, 1998~No~DISCN~VINT
AGE PHARMACEUTICALS LLC
TAMINOPHEN~VINTAGE PHARMS LLC~500MG;7.5MG~A~040280~001~~Sep 30, 1998~No~DISCN~VI
NTAGE PHARMACEUTICALS LLC
TAMINOPHEN~VINTAGE PHARMS LLC~650MG;10MG~A~040280~003~~Sep 30, 1998~No~DISCN~VIN
TAGE PHARMACEUTICALS LLC
TAMINOPHEN~WATSON LABS~325MG;7.5MG~A~040248~001~~Apr 28, 2000~No~DISCN~WATSON LA
BORATORIES INC
TAMINOPHEN~WATSON LABS~325MG;10MG~A~040248~002~~Apr 28, 2000~No~DISCN~WATSON LAB
ORATORIES INC
TAMINOPHEN~WATSON LABS~500MG;2.5MG~A~040123~003~~Mar 4, 1996~No~DISCN~WATSON LAB
ORATORIES INC
TAMINOPHEN~WATSON LABS~500MG;2.5MG~A~081079~001~~Aug 30, 1991~No~DISCN~WATSON LA
BORATORIES INC
TAMINOPHEN~WATSON LABS~500MG;5MG~A~040122~001~~Mar 4, 1996~No~DISCN~WATSON LABOR
ATORIES INC
TAMINOPHEN~WATSON LABS~500MG;5MG~A~089883~001~~Dec 1, 1988~No~DISCN~WATSON LABOR
ATORIES INC
ORATORIES INC
BORATORIES INC
TAMINOPHEN~WATSON LABS~650MG;7.5MG~A~040094~001~~Sep 29, 1995~No~DISCN~WATSON LA
BORATORIES INC
ORATORIES INC
TAMINOPHEN~WATSON LABS~650MG;10MG~A~040094~002~~Sep 29, 1995~No~DISCN~WATSON LAB
ORATORIES INC
TAMINOPHEN~WATSON LABS~650MG;10MG~A~040123~002~~Mar 4, 1996~No~DISCN~WATSON LABO
RATORIES INC
TAMINOPHEN~WATSON LABS~660MG;10MG~A~040094~003~~Aug 8, 2000~No~DISCN~WATSON LABO
RATORIES INC
ORATORIES INC
BORATORIES INC
TAMINOPHEN~WATSON LABS~750MG;10MG~A~040094~004~~Mar 22, 1999~No~DISCN~WATSON LAB
ORATORIES INC
TAMINOPHEN~WATSON LABS FLORIDA~500MG;5MG~A~040493~001~~May 28, 2003~No~DISCN~WAT
SON LABORATORIES INC FLORIDA
TAMINOPHEN~WATSON LABS FLORIDA~660MG;10MG~A~040495~001~~May 28, 2003~No~DISCN~WA
TSON LABORATORIES INC FLORIDA
TAMINOPHEN~WATSON LABS FLORIDA~750MG;7.5MG~A~040494~001~~May 28, 2003~No~DISCN~W
ATSON LABORATORIES INC FLORIDA
HYDROCODONE BITARTRATE; IBUPROFEN~TABLET;ORAL~HYDROCODONE BITARTRATE AND IBUPROF
EN~ACTAVIS LABS FL INC~5MG;200MG~A~077454~001~AB~Jun 23, 2010~No~RX~ACTAVIS LABO
RATORIES FL INC
EN~ACTAVIS LABS FL INC~7.5MG;200MG~A~076604~001~AB~Dec 31, 2003~No~RX~ACTAVIS LA
BORATORIES FL INC
EN~AMNEAL PHARMS NY~5MG;200MG~A~076642~002~AB~Mar 18, 2004~No~RX~AMNEAL PHARMACE
UTICALS NY LLC
EN~AMNEAL PHARMS NY~7.5MG;200MG~A~076642~001~AB~Oct 12, 2004~No~RX~AMNEAL PHARMA
CEUTICALS NY LLC
EN~SUN PHARM INDS INC~2.5MG;200MG~A~091633~001~AB~May 28, 2013~No~RX~SUN PHARMAC
EN~SUN PHARM INDS INC~5MG;200MG~A~091633~002~AB~May 28, 2013~No~RX~SUN PHARMACEU
TICAL INDUSTRIES INC
EN~SUN PHARM INDS INC~7.5MG;200MG~A~091633~003~AB~May 28, 2013~No~RX~SUN PHARMAC
EN~SUN PHARM INDS INC~10MG;200MG~A~091633~004~AB~May 28, 2013~No~RX~SUN PHARMACE
UTICAL INDUSTRIES INC
EN~TEVA~7.5MG;200MG~A~076023~001~AB~Apr 11, 2003~No~RX~TEVA PHARMACEUTICALS USA
INC
EN~VINTAGE PHARMS~5MG;200MG~A~077727~001~AB~Nov 6, 2006~No~RX~VINTAGE PHARMACEUT
ICALS INC
EN~VINTAGE PHARMS~7.5MG;200MG~A~077723~001~AB~Nov 6, 2006~No~RX~VINTAGE PHARMACE
UTICALS INC
EN~VINTAGE PHARMS~10MG;200MG~A~077723~002~AB~Nov 6, 2006~No~RX~VINTAGE PHARMACEU
TICALS INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~AMEDRA PHARMS~5MG~A~040646~001~AB~Mar
30, 2007~No~RX~AMEDRA PHARMACEUTICALS LLC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~BARR~20MG~A~083999~001~~Approved Prior
to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~ELKINS SINN~20MG~A~080624~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~FERRANTE~10MG~A~080568~001~~Approved P
rior to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~FERRANTE~20MG~A~080568~002~~Approved P
rior to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~HIKMA INTL PHARMS~5MG~A~083365~002~AB~
Feb 23, 2015~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~HIKMA INTL PHARMS~10MG~A~083365~003~AB
~Feb 23, 2015~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~HIKMA INTL PHARMS~20MG~A~083365~001~AB
~Approved Prior to Jan 1, 1982~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~IMPAX LABS~20MG~A~080781~001~~Approved
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~INWOOD LABS~20MG~A~080732~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES
INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~LANNETT~20MG~A~085070~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~LANNETT CO INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~NEXGEN PHARMA INC~20MG~A~083140~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~PANRAY~10MG~N~009659~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~PANRAY~20MG~N~009659~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~PARKE DAVIS~20MG~A~084243~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~PUREPAC PHARM~10MG~A~084247~003~~Aug 3
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~PUREPAC PHARM~20MG~A~080395~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~PUREPAC PHARM~20MG~A~084247~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~ROXANE~10MG~A~088539~001~~Mar 21, 1984
~No~DISCN~ROXANE LABORATORIES INC
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~SANDOZ~20MG~A~080642~002~~Approved Pri
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~VINTAGE~5MG~A~040761~001~AB~Jul 16, 20

HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~WATSON LABS~20MG~A~080355~001~~Approve
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~WHITEWORTH TOWN PLSN~10MG~A~080344~001
HYDROCORTISONE~TABLET;ORAL~HYDROCORTISONE~WHITEWORTH TOWN PLSN~20MG~A~080344~002
HYDROCORTISONE~TABLET;ORAL~HYDROCORTONE~MERCK~10MG~N~008506~007~~Approved Prior
HYDROCORTISONE~TABLET;ORAL~HYDROCORTONE~MERCK~20MG~N~008506~011~~Approved Prior
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDRODIURIL~MERCK~25MG~N~011835~003~~Approved Pr
ior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDRODIURIL~MERCK~50MG~N~011835~006~~Approved Pr
ior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
HYDROCHLOROTHIAZIDE~TABLET;ORAL~HYDRODIURIL~MERCK~100MG~N~011835~007~~Approved P
rior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
HYDROFLUMETHIAZIDE~TABLET;ORAL~HYDROFLUMETHIAZIDE~PAR PHARM~50MG~A~088850~001~~M
ay 31, 1985~No~DISCN~PAR PHARMACEUTICAL INC
HYDROFLUMETHIAZIDE~TABLET;ORAL~HYDROFLUMETHIAZIDE~WATSON LABS~50MG~A~088031~001~
~Apr 6, 1983~No~DISCN~WATSON LABORATORIES INC
HYDROFLUMETHIAZIDE~TABLET;ORAL~HYDROFLUMETHIAZIDE~WATSON LABS~50MG~A~088528~001~
~Aug 15, 1984~No~DISCN~WATSON LABORATORIES INC
HYDROFLUMETHIAZIDE; RESERPINE~TABLET;ORAL~HYDROFLUMETHIAZIDE AND RESERPINE~USL P
HARMA~50MG;0.125MG~A~088195~001~~Oct 26, 1983~No~DISCN~USL PHARMA INC
HYDROFLUMETHIAZIDE; RESERPINE~TABLET;ORAL~HYDROFLUMETHIAZIDE AND RESERPINE~WATSO
N LABS~25MG;0.125MG~A~088127~001~~Mar 22, 1983~No~DISCN~WATSON LABORATORIES INC
HYDROFLUMETHIAZIDE; RESERPINE~TABLET;ORAL~HYDROFLUMETHIAZIDE AND RESERPINE~WATSO
N LABS~50MG;0.125MG~A~088110~001~~Mar 22, 1983~No~DISCN~WATSON LABORATORIES INC
HYDROMORPHONE HYDROCHLORIDE~TABLET;ORAL~HYDROMORPHONE HYDROCHLORIDE~ELITE LABS~8
MG~A~076723~001~AB~Oct 18, 2005~No~RX~ELITE LABORATORIES INC
HYDROMORPHONE HYDROCHLORIDE~TABLET;ORAL~HYDROMORPHONE HYDROCHLORIDE~LANNETT~2MG~
A~078439~001~AB~Dec 9, 2009~No~RX~LANNETT HOLDINGS INC
HYDROMORPHONE HYDROCHLORIDE~TABLET;ORAL~HYDROMORPHONE HYDROCHLORIDE~MALLINCKRODT
~8MG~A~076855~001~AB~Dec 23, 2004~No~RX~MALLINCKRODT INC
INC~2MG~A~078273~001~AB~Sep 19, 2007~No~RX~MALLINCKRODT INC
INC~4MG~A~078273~002~AB~Sep 19, 2007~No~RX~MALLINCKRODT INC
HYDROMORPHONE HYDROCHLORIDE~TABLET;ORAL~HYDROMORPHONE HYDROCHLORIDE~NESHER PHARM
S~2MG~A~077311~001~~Nov 9, 2005~No~DISCN~NESHER PHARMACEUTICALS USA LLC
HYDROMORPHONE HYDROCHLORIDE~TABLET;ORAL~HYDROMORPHONE HYDROCHLORIDE~ROXANE~4MG~A
~074597~003~AB~May 29, 2009~No~RX~ROXANE LABORATORIES INC
HYDROMORPHONE HYDROCHLORIDE~TABLET;ORAL~HYDROMORPHONE HYDROCHLORIDE~ROXANE~8MG~A
~074597~001~AB~Jul 29, 1998~No~RX~ROXANE LABORATORIES INC
QUINETHAZONE~TABLET;ORAL~HYDROMOX~LEDERLE~50MG~N~013264~001~~Approved Prior to J
an 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
QUINETHAZONE; RESERPINE~TABLET;ORAL~HYDROMOX R~LEDERLE~50MG;0.125MG~N~013927~001
MID CO
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROPRES 25~MERCK~25MG;0.125MG~N~011
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROPRES 50~MERCK~50MG;0.125MG~N~011

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~HYDROSERPI
NE PLUS (R-H-H)~IVAX SUB TEVA PHARMS~25MG;15MG;0.1MG~A~083877~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~HYDROXYCHLOROQUINE SULFATE~HIKMA PHARMS L
LC~200MG~A~040760~001~AB~Aug 15, 2007~No~RX~HIKMA PHARMACEUTICALS LLC
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~HYDROXYCHLOROQUINE SULFATE~IPCA LABS LTD~
200MG~A~040766~001~AB~Jun 14, 2007~No~RX~IPCA LABORATORIES LTD
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~HYDROXYCHLOROQUINE SULFATE~MYLAN~200MG~A~
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~HYDROXYCHLOROQUINE SULFATE~SANDOZ~200MG~A
~040104~001~AB~Nov 30, 1995~No~RX~SANDOZ INC
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~HYDROXYCHLOROQUINE SULFATE~SANDOZ~200MG~A
~040150~001~~Jan 27, 1996~No~DISCN~SANDOZ INC
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~HYDROXYCHLOROQUINE SULFATE~TEVA PHARMS~20
0MG~A~040081~001~AB~Sep 30, 1994~No~RX~TEVA PHARMACEUTICALS USA
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~HYDROXYCHLOROQUINE SULFATE~WATSON LABS~20
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~HYDROXYCHLOROQUINE SULFATE~ZYDUS PHARMS U
SA INC~200MG~A~040657~001~AB~Sep 21, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
HYDROXYUREA~TABLET;ORAL~HYDROXYUREA~BARR~1GM~A~075734~001~~Aug 29, 2000~No~DISCN
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~ABLE~10MG~A~0405
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~ACTAVIS ELIZABET
H~10MG~A~089071~001~~Jul 22, 1986~No~DISCN~ACTAVIS ELIZABETH LLC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~AMNEAL PHARM~10M
G~A~040808~001~AB~Sep 24, 2008~No~RX~AMNEAL PHARMACEUTICAL
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~EMCURE PHARMS US
A~10MG~A~204279~001~AB~Aug 20, 2014~No~RX~EMCURE PHARMACEUTICALS USA INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~HALSEY~10MG~A~08
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~HERITAGE PHARMS
INC~10MG~A~040804~001~AB~Jun 30, 2008~No~RX~HERITAGE PHARMACEUTICALS INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~HETERO LABS LTD
III~10MG~A~040805~001~AB~May 29, 2008~No~RX~HETERO LABS LTD UNIT III

HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~INVAGEN PHARMS~1
0MG~A~040812~001~AB~Mar 12, 2008~No~RX~INVAGEN PHARMACEUTICALS INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~IVAX PHARMS~10MG
~A~087216~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~KV PHARM~10MG~A~
087819~001~~Jun 23, 1982~No~DISCN~KV PHARMACEUTICAL CO
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~KV PHARM~100MG~A
~087822~001~~Jun 23, 1982~No~DISCN~KV PHARMACEUTICAL CO
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~KVK TECH~10MG~A~
040786~001~AB~Mar 20, 2007~No~RX~KVK TECH INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~MIKAH PHARMA~10M
G~A~040600~001~~Dec 28, 2004~No~DISCN~MIKAH PHARMA LLC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~MUTUAL PHARM~10M
G~A~088409~001~~Nov 15, 1983~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
G~A~089381~001~AB~May 19, 1986~No~RX~MUTUAL PHARMACEUTICAL CO INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~MUTUAL PHARM~100
MG~A~087862~001~~Apr 18, 1983~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~MYLAN~10MG~A~091
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~NORTHSTAR HLTHCA
RE~10MG~A~040841~001~AB~Mar 31, 2008~No~RX~NORTHSTAR HEALTHCARE HOLDINGS LTD

HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~PLIVA~10MG~A~088
617~001~AB~Jan 10, 1986~Yes~RX~PLIVA INC
1054~001~~Sep 25, 1995~No~DISCN~PLIVA INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~PUREPAC PHARM~10
MG~A~088120~001~~Sep 25, 1984~No~DISCN~PUREPAC PHARMACEUTICAL CO
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~QUANTUM PHARMICS
~10MG~A~088540~001~~Oct 22, 1985~No~DISCN~QUANTUM PHARMICS LTD
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~SANDOZ~10MG~A~08
7869~001~~Dec 20, 1982~No~DISCN~SANDOZ INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~SUN PHARM INDS I
NC~10MG~A~040899~001~AB~Jun 10, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~SUPERPHARM~10MG~
A~088794~001~~Dec 5, 1984~No~DISCN~SUPERPHARM CORP
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~USL PHARMA~10MG~
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~VINTAGE~10MG~A~0
87602~001~~Jan 22, 1982~No~DISCN~VINTAGE PHARMACEUTICALS LLC
HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~VINTAGE PHARMS~1
0MG~A~040579~001~AB~May 27, 2005~No~RX~VINTAGE PHARMACEUTICALS INC

HYDROXYZINE HYDROCHLORIDE~TABLET;ORAL~HYDROXYZINE HYDROCHLORIDE~WATSON LABS~10MG
~A~081149~001~~Mar 18, 1994~No~DISCN~WATSON LABORATORIES INC
~A~088348~001~AB~Sep 15, 1983~No~RX~WATSON LABORATORIES INC
CHLORTHALIDONE~TABLET;ORAL~HYGROTON~SANOFI AVENTIS US~25MG~N~012283~004~~Approve
CHLORTHALIDONE~TABLET;ORAL~HYGROTON~SANOFI AVENTIS US~50MG~N~012283~003~~Approve
GUANADREL SULFATE~TABLET;ORAL~HYLOREL~PHARMACIA AND UPJOHN~10MG~N~018104~001~~De
c 29, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
GUANADREL SULFATE~TABLET;ORAL~HYLOREL~PHARMACIA AND UPJOHN~25MG~N~018104~002~~De
c 29, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~HYSERPIN~PHYS PRODS VA~50MG~N~010581~001~~
Approved Prior to Jan 1, 1982~No~DISCN~PHYSICIANS PRODUCTS CO INC DIV INTERNATIO
NAL LATEX CORP
TERAZOSIN HYDROCHLORIDE~TABLET;ORAL~HYTRIN~ABBOTT~EQ 1MG BASE~N~019057~001~~Aug
7, 1987~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM~TABLET;ORAL~HYZAAR~MERCK SHARP DOHME~12.
5MG;50MG~N~020387~001~AB~Apr 28, 1995~No~RX~MERCK SHARP AND DOHME CORP
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM~TABLET;ORAL~HYZAAR~MERCK SHARP DOHME~12.
5MG;100MG~N~020387~003~AB~Oct 20, 2005~No~RX~MERCK SHARP AND DOHME CORP
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM~TABLET;ORAL~HYZAAR~MERCK SHARP DOHME~25M
G;100MG~N~020387~002~AB~Nov 10, 1998~Yes~RX~MERCK SHARP AND DOHME CORP
ISONIAZID~TABLET;ORAL~HYZYD~MEDPOINTE PHARM HLC~100MG~A~080134~003~~Approved Pri
or to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
ISONIAZID~TABLET;ORAL~HYZYD~MEDPOINTE PHARM HLC~300MG~A~080134~004~~Approved Pri
or to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
IBANDRONATE SODIUM~TABLET;ORAL~IBANDRONATE SODIUM~APOTEX INC~EQ 150MG BASE~A~078
948~001~AB~Mar 19, 2012~No~RX~APOTEX INC
IBANDRONATE SODIUM~TABLET;ORAL~IBANDRONATE SODIUM~DR REDDYS LABS LTD~EQ 150MG BA
SE~A~078997~001~AB~Apr 30, 2012~No~RX~DR REDDYS LABORATORIES LTD
IBANDRONATE SODIUM~TABLET;ORAL~IBANDRONATE SODIUM~MUTUAL PHARM CO INC~EQ 150MG B
ASE~A~078996~001~AB~Aug 15, 2012~No~RX~MUTUAL PHARMACEUTICAL CO INC
IBANDRONATE SODIUM~TABLET;ORAL~IBANDRONATE SODIUM~MYLAN PHARMS INC~EQ 150MG BASE
~A~078995~001~AB~Mar 19, 2012~No~RX~MYLAN PHARMACEUTICALS INC
IBANDRONATE SODIUM~TABLET;ORAL~IBANDRONATE SODIUM~ORCHID HLTHCARE~EQ 150MG BASE~

A~078998~001~AB~Mar 19, 2012~No~RX~ORCHID HEALTHCARE
IBANDRONATE SODIUM~TABLET;ORAL~IBANDRONATE SODIUM~WATSON LABS INC~EQ 150MG BASE~
A~079003~001~AB~Mar 20, 2012~No~RX~WATSON LABORATORIES INC
IBUPROFEN~TABLET;ORAL~IBU~BASF~400MG~A~070083~001~~Feb 22, 1985~No~DISCN~BASF CO
RP
IBUPROFEN~TABLET;ORAL~IBU~BASF~400MG~N~018197~001~~Approved Prior to Jan 1, 1982
~No~DISCN~BASF CORP
IBUPROFEN~TABLET;ORAL~IBU~BASF~600MG~A~070088~001~~Feb 8, 1985~No~DISCN~BASF COR
P
IBUPROFEN~TABLET;ORAL~IBU~BASF~600MG~A~070099~001~~Mar 29, 1985~No~DISCN~BASF CO
RP
IBUPROFEN~TABLET;ORAL~IBU~BASF~800MG~A~070745~001~~Jul 23, 1986~No~DISCN~BASF CO
RP
IBUPROFEN~TABLET;ORAL~IBU-TAB~ALRA~400MG~A~071058~001~AB~Aug 11, 1988~No~RX~ALRA
LABORATORIES INC
IBUPROFEN~TABLET;ORAL~IBU-TAB~ALRA~600MG~A~071059~001~AB~Aug 11, 1988~No~RX~ALRA
LABORATORIES INC
IBUPROFEN~TABLET;ORAL~IBU-TAB~ALRA~800MG~A~071965~001~~Aug 11, 1988~No~DISCN~ALR
A LABORATORIES INC
IBUPROFEN~TABLET;ORAL~IBU-TAB 200~ALRA~200MG~A~071057~001~~Aug 11, 1988~No~OTC~A
LRA LABORATORIES INC
IBUPROFEN~TABLET;ORAL~IBUPRIN~PLIVA~200MG~A~071773~001~~Jul 16, 1987~No~DISCN~PL
IVA INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~ABBOTT~600MG~A~070556~001~~Jun 14, 1985~No~DISCN
IBUPROFEN~TABLET;ORAL~IBUPROFEN~ABBOTT~800MG~A~071264~001~~Jul 25, 1986~No~DISCN
IBUPROFEN~TABLET;ORAL~IBUPROFEN~AMNEAL PHARMS~200MG~A~079233~001~~Mar 18, 2014~N
o~OTC~AMNEAL PHARMACEUTICALS
IBUPROFEN~TABLET;ORAL~IBUPROFEN~AMNEAL PHARMS NY~200MG~A~071333~001~~Feb 17, 198
7~No~OTC~AMNEAL PHARMACEUTICALS NY LLC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~AMNEAL PHARMS NY~200MG~A~072199~001~~May 23, 198
8~No~OTC~AMNEAL PHARMACEUTICALS NY LLC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~AMNEAL PHARMS NY~400MG~A~071334~001~AB~Nov 25, 1
986~No~RX~AMNEAL PHARMACEUTICALS NY LLC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~AMNEAL PHARMS NY~400MG~A~078558~001~AB~Jun 18, 2
IBUPROFEN~TABLET;ORAL~IBUPROFEN~AMNEAL PHARMS NY~600MG~A~071335~001~AB~Nov 25, 1
IBUPROFEN~TABLET;ORAL~IBUPROFEN~AMNEAL PHARMS NY~800MG~A~071935~001~AB~Oct 13, 1
IBUPROFEN~TABLET;ORAL~IBUPROFEN~AVEMA PHARMA~200MG~A~076460~001~~Nov 26, 2003~No
~OTC~AVEMA PHARMA SOLUTIONS
IBUPROFEN~TABLET;ORAL~IBUPROFEN~CONTRACT PHARMACAL~200MG~A~071732~001~~Sep 10, 1
IBUPROFEN~TABLET;ORAL~IBUPROFEN~CONTRACT PHARMACAL~200MG~A~071735~001~~Sep 10, 1
IBUPROFEN~TABLET;ORAL~IBUPROFEN~CONTRACT PHARMACAL~200MG~A~072299~001~~Jul 1, 19
IBUPROFEN~TABLET;ORAL~IBUPROFEN~CONTRACT PHARMACAL~200MG~A~073691~001~~Feb 25, 1
994~No~DISCN~CONTRACT PHARMACAL CORP
IBUPROFEN~TABLET;ORAL~IBUPROFEN~CONTRACT PHARMACAL~200MG~A~074931~001~~Jul 20, 1
IBUPROFEN~TABLET;ORAL~IBUPROFEN~CONTRACT PHARMACAL~400MG~A~071267~001~AB~Oct 15,
1986~No~RX~CONTRACT PHARMACAL CORP
IBUPROFEN~TABLET;ORAL~IBUPROFEN~CONTRACT PHARMACAL~600MG~A~071268~001~AB~Oct 15,

IBUPROFEN~TABLET;ORAL~IBUPROFEN~CONTRACT PHARMACAL~800MG~A~072300~001~AB~Jul 1,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~DR REDDYS LA~200MG~A~075661~001~~Dec 12, 2001~No
~OTC~DR REDDYS LABORATORIES LOUISIANA LLC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~DR REDDYS LA~400MG~A~075682~001~AB~Nov 14, 2001~
No~RX~DR REDDYS LABORATORIES LOUISIANA LLC
No~RX~DR REDDYS LABORATORIES LOUISIANA LLC
Yes~RX~DR REDDYS LABORATORIES LOUISIANA LLC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~DR REDDYS LABS INC~100MG~A~076117~001~~Nov 20, 2
001~No~OTC~DR REDDYS LABORATORIES INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~DR REDDYS LABS INC~400MG~A~076112~001~AB~Oct 31,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~GRANULES INDIA~200MG~A~079174~001~~Dec 10, 2010~
No~OTC~GRANULES INDIA LTD
IBUPROFEN~TABLET;ORAL~IBUPROFEN~HALSEY~200MG~A~071027~001~~Sep 29, 1987~No~DISCN
~HALSEY DRUG CO INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~HALSEY~300MG~A~071028~001~~Mar 23, 1987~No~DISCN
~HALSEY DRUG CO INC
~HALSEY DRUG CO INC
~HALSEY DRUG CO INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~HALSEY~800MG~A~072137~001~~Feb 5, 1988~No~DISCN~
HALSEY DRUG CO INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~IVAX SUB TEVA PHARMS~200MG~A~071144~001~~Jan 20,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~IVAX SUB TEVA PHARMS~200MG~A~071154~001~~Oct 27,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~IVAX SUB TEVA PHARMS~200MG~A~072040~001~~Apr 29,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~IVAX SUB TEVA PHARMS~200MG~A~072901~001~~Dec 19,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~IVAX SUB TEVA PHARMS~200MG~A~072903~001~~Dec 19,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~IVAX SUB TEVA PHARMS~400MG~A~071145~001~~Sep 23,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~IVAX SUB TEVA PHARMS~600MG~A~071146~001~~Sep 23,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~IVAX SUB TEVA PHARMS~800MG~A~071769~001~~May 8,
IBUPROFEN~TABLET;ORAL~IBUPROFEN~LEDERLE~400MG~A~070629~001~~Sep 19, 1986~No~DISC
N~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
IBUPROFEN~TABLET;ORAL~IBUPROFEN~LEDERLE~600MG~A~070630~001~~Sep 19, 1986~No~DISC
N~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
IBUPROFEN~TABLET;ORAL~IBUPROFEN~LEINER~300MG~A~071266~001~~Oct 15, 1986~No~DISCN
~LEINER HEALTH PRODUCTS INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~LNK~100MG~A~076741~001~~Jun 17, 2004~No~OTC~LNK
INTERNATIONAL INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~LNK~200MG~A~075010~001~~Mar 1, 1999~No~OTC~LNK I
NTERNATIONAL INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~LNK~200MG~A~075139~001~~Mar 1, 1999~No~OTC~LNK I
NTERNATIONAL INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MARKSANS PHARMA~200MG~A~091237~001~~Feb 8, 2011~

No~OTC~MARKSANS PHARMA LTD
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MARKSANS PHARMA~200MG~A~091239~001~~Feb 1, 2011~
No~OTC~MARKSANS PHARMA LTD
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MARKSANS PHARMA~400MG~A~090796~001~AB~Dec 21, 20
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MCNEIL~200MG~A~073019~001~~Mar 30, 1994~No~OTC~M
CNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MCNEIL~400MG~A~070081~001~~Jun 16, 1986~No~DISCN
~MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MCNEIL~600MG~A~070476~001~~Jun 16, 1986~No~DISCN
~MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MERRO PHARM~200MG~A~070985~001~~Oct 2, 1987~No~O
TC~MERRO PHARMACEUTICAL CO LTD
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MUTUAL PHARM~200MG~A~070493~001~~Dec 24, 1985~No
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MUTUAL PHARM~200MG~A~070908~001~~Sep 26, 1986~No
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MUTUAL PHARM~200MG~A~071462~001~~Oct 2, 1986~No~
DISCN~MUTUAL PHARMACEUTICAL CO INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MUTUAL PHARM~400MG~A~070079~001~~Jul 24, 1985~No
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MUTUAL PHARM~600MG~A~070080~001~~Jul 24, 1985~No
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MUTUAL PHARM~800MG~A~071448~001~~Feb 18, 1987~No
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MYLAN~200MG~A~071870~001~~May 5, 1988~No~DISCN~M
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MYLAN~400MG~A~070045~001~~Sep 24, 1985~No~DISCN~
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MYLAN~600MG~A~070057~001~~Sep 24, 1985~No~DISCN~
IBUPROFEN~TABLET;ORAL~IBUPROFEN~MYLAN~800MG~A~071999~001~~Dec 3, 1987~No~DISCN~M
IBUPROFEN~TABLET;ORAL~IBUPROFEN~NORTHSTAR HLTHCARE~400MG~A~078132~001~~Sep 10, 2
007~No~DISCN~NORTHSTAR HEALTHCARE HOLDINGS
IBUPROFEN~TABLET;ORAL~IBUPROFEN~OHM~200MG~A~071163~001~~Jul 15, 1986~No~OTC~OHM
CORP
IBUPROFEN~TABLET;ORAL~IBUPROFEN~OHM LABS~400MG~A~070818~001~~Dec 26, 1985~No~DIS
CN~OHM LABORATORIES INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PAR PHARM~200MG~A~070481~001~~Sep 24, 1986~No~OT
C~PAR PHARMACEUTICAL INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PAR PHARM~200MG~A~071575~001~~May 8, 1987~No~DIS
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PAR PHARM~300MG~A~070328~001~~Aug 6, 1985~No~DIS
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PAR PHARM~800MG~A~070986~001~~Jul 25, 1986~No~DI
SCN~PAR PHARMACEUTICAL INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PERRIGO~200MG~A~072096~001~~Dec 8, 1987~No~OTC~L
PERRIGO CO
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PERRIGO~200MG~A~072098~001~~Dec 8, 1987~No~DISCN
~L PERRIGO CO
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PERRIGO~200MG~A~075995~001~~Mar 14, 2002~No~OTC~
L PERRIGO CO
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PERRIGO R AND D~200MG~A~077349~001~~Jun 21, 2005
~No~OTC~PERRIGO R AND D CO
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PERRIGO R AND D~400MG~A~077114~001~AB~Jul 18, 20
05~No~RX~PERRIGO R AND D CO
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PLIVA~400MG~A~071666~001~~Jun 18, 1987~No~DISCN~
PLIVA INC
PLIVA INC
PLIVA INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PUREPAC PHARM~200MG~A~071122~001~~Oct 3, 1986~No
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PUREPAC PHARM~200MG~A~071664~001~~Feb 3, 1987~No
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PUREPAC PHARM~300MG~A~071123~001~~Sep 19, 1986~N
IBUPROFEN~TABLET;ORAL~IBUPROFEN~PUREPAC PHARM~800MG~A~071964~001~~Feb 1, 1988~No
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SANDOZ~200MG~A~070733~001~~Sep 19, 1986~No~DISCN
~SANDOZ INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SANDOZ~200MG~A~071807~001~~Feb 25, 1988~No~DISCN
~SANDOZ INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SANDOZ~200MG~A~074525~001~~Dec 15, 1995~No~DISCN
~SANDOZ INC
~SANDOZ INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SANDOZ~300MG~A~070734~001~~Jun 12, 1986~No~DISCN
~SANDOZ INC
~SANDOZ INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SANDOZ~400MG~A~072064~001~~Jan 14, 1988~No~DISCN
~SANDOZ INC
~SANDOZ INC
~SANDOZ INC
~SANDOZ INC
~SANDOZ INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SHASUN USA~400MG~A~078329~001~AB~Feb 5, 2009~No~
RX~SHASUN USA INC
RX~SHASUN USA INC
RX~SHASUN USA INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SUPERPHARM~600MG~A~070709~001~~Apr 25, 1986~No~D

ISCN~SUPERPHARM CORP
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SVADS HOLDINGS SA~200MG~A~079129~001~~Mar 28, 20
11~No~OTC~SVADS HOLDINGS SA
IBUPROFEN~TABLET;ORAL~IBUPROFEN~SVADS HOLDINGS SA~200MG~A~091355~001~~Apr 4, 201
1~No~OTC~SVADS HOLDINGS SA
IBUPROFEN~TABLET;ORAL~IBUPROFEN~TEVA~200MG~A~073141~001~~May 29, 1992~No~DISCN~T
IBUPROFEN~TABLET;ORAL~IBUPROFEN~TEVA~400MG~A~073343~001~~Jun 30, 1992~No~DISCN~T
IBUPROFEN~TABLET;ORAL~IBUPROFEN~VINTAGE PHARMS~200MG~A~071229~001~~Apr 1, 1987~N
o~OTC~VINTAGE PHARMACEUTICALS INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~VINTAGE PHARMS~200MG~A~071639~001~~Feb 2, 1988~N
o~OTC~VINTAGE PHARMACEUTICALS INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~VINTAGE PHARMS~200MG~A~072249~001~~Jan 10, 1989~
No~DISCN~VINTAGE PHARMACEUTICALS INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~VINTAGE PHARMS~300MG~A~071230~001~AB~Oct 22, 198
IBUPROFEN~TABLET;ORAL~IBUPROFEN~VINTAGE PHARMS~400MG~A~071644~001~AB~Feb 1, 1988
~No~RX~VINTAGE PHARMACEUTICALS INC
IBUPROFEN~TABLET;ORAL~IBUPROFEN~VINTAGE PHARMS~800MG~A~072004~001~AB~Nov 18, 198
IBUPROFEN~TABLET;ORAL~IBUPROFEN~WATSON LABS~200MG~A~070435~001~~Mar 5, 1986~No~D
IBUPROFEN~TABLET;ORAL~IBUPROFEN~WATSON LABS~200MG~A~071765~001~~Sep 4, 1987~No~D
IBUPROFEN~TABLET;ORAL~IBUPROFEN~WATSON LABS~200MG~A~071905~001~~Mar 8, 1988~No~D
IBUPROFEN~TABLET;ORAL~IBUPROFEN~WATSON LABS~300MG~A~071338~001~~Dec 1, 1986~No~D
IBUPROFEN~TABLET;ORAL~IBUPROFEN~WATSON LABS~400MG~A~070436~001~~Aug 21, 1985~No~
IBUPROFEN~TABLET;ORAL~IBUPROFEN~WATSON LABS~600MG~A~070437~001~~Aug 21, 1985~No~
IBUPROFEN~TABLET;ORAL~IBUPROFEN~WATSON LABS~800MG~A~071547~001~~Jul 2, 1987~No~D
IBUPROFEN~TABLET;ORAL~IBUPROFEN~WATSON LABS~800MG~A~071911~001~~Oct 13, 1987~No~
DIPHENHYDRAMINE CITRATE; IBUPROFEN~TABLET;ORAL~IBUPROFEN AND DIPHENHYDRAMINE CIT
RATE~DR REDDYS LABS LTD~38MG;200MG~A~090619~001~~Jul 8, 2009~No~OTC~DR REDDYS LA
BORATORIES LTD
DIPHENHYDRAMINE CITRATE; IBUPROFEN~TABLET;ORAL~IBUPROFEN AND DIPHENHYDRAMINE CIT
RATE~PERRIGO R AND D~38MG;200MG~A~079113~001~~Dec 22, 2008~No~OTC~PERRIGO R AND
D CO
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE~TABLET;ORAL~IBUPROFEN AND PHENYLEPHRINE H
YDROCHLORIDE~PERRIGO R AND D~200MG;10MG~A~203200~001~~Jul 3, 2014~No~OTC~PERRIGO
R AND D CO
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET;ORAL~IBUPROFEN AND PSEUDOEPHEDRI
NE HYDROCHLORIDE~CONTRACT PHARMACAL~200MG;30MG~A~075588~001~~Apr 8, 2002~No~OTC~

CONTRACT PHARMACAL CORP
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET;ORAL~IBUPROFEN AND PSEUDOEPHEDRI
NE HYDROCHLORIDE~DR REDDYS LABS LTD~200MG;30MG~A~077628~001~~Aug 14, 2006~No~OTC
~DR REDDYS LABORATORIES LTD
IBUPROFEN~TABLET;ORAL~IBUPROHM~OHM LABS~200MG~A~071214~001~~Dec 1, 1986~No~OTC~O
HM LABORATORIES INC
IBUPROFEN~TABLET;ORAL~IBUPROHM~OHM LABS~400MG~A~070469~001~~Aug 29, 1985~No~DISC
N~OHM LABORATORIES INC.
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET;ORAL~IBUPROHM COLD AND SINUS~OHM
LABS~200MG;30MG~A~074567~001~~Apr 17, 2001~No~OTC~OHM LABORATORIES INC
PONATINIB HYDROCHLORIDE~TABLET;ORAL~ICLUSIG~ARIAD~EQ 15MG BASE~N~203469~001~~Dec
14, 2012~No~RX~ARIAD PHARMACEUTICALS INC
PONATINIB HYDROCHLORIDE~TABLET;ORAL~ICLUSIG~ARIAD~EQ 45MG BASE~N~203469~002~~Dec
14, 2012~Yes~RX~ARIAD PHARMACEUTICALS INC
ERYTHROMYCIN ESTOLATE~TABLET;ORAL~ILOSONE~LILLY~EQ 500MG BASE~A~061896~001~~Appr
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~EXCELLIUM~10MG~A~0
40903~001~AB~Oct 24, 2012~No~RX~EXCELLIUM PHARMACEUTICAL INC
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~LEDERLE~10MG~A~086
269~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICA
N CYANAMID CO
N CYANAMID CO
N CYANAMID CO
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~LUPIN LTD~10MG~A~0
90443~001~AB~Mar 11, 2010~No~RX~LUPIN LTD
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~MUTUAL PHARM~10MG~
A~081048~001~AB~Jun 5, 1990~No~RX~MUTUAL PHARMACEUTICAL CO INC
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~PAR PHARM~10MG~A~0
89422~001~AB~Jul 14, 1987~No~RX~PAR PHARMACEUTICAL INC
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~PROSAM LABS~10MG~A
~040753~001~~Feb 28, 2008~No~DISCN~PROSAM LABS LLC
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~ROXANE~10MG~A~0837

IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~SANDOZ~10MG~A~0849
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~TEVA~10MG~A~083729
~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~USL PHARMA~25MG~A~
087776~001~~Feb 10, 1982~No~DISCN~USL PHARMA INC
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~VANGARD~10MG~A~088
036~001~~Nov 3, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
619~001~~Feb 9, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
631~001~~Jan 4, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~WATSON LABS~10MG~A
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~WEST WARD~25MG~A~0
88222~001~~May 26, 1983~No~DISCN~WEST WARD PHARMACEUTICAL CORP
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~IMIPRAMINE HYDROCHLORIDE~WEST WARD~50MG~A~0
88223~001~~May 26, 1983~No~DISCN~WEST WARD PHARMACEUTICAL CORP
SUMATRIPTAN SUCCINATE~TABLET;ORAL~IMITREX~GLAXOSMITHKLINE~EQ 25MG BASE~N~020132~
002~AB~Jun 1, 1995~No~RX~GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE~TABLET;ORAL~IMITREX~GLAXOSMITHKLINE~EQ 50MG BASE~N~020132~
003~AB~Jun 1, 1995~No~RX~GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE~TABLET;ORAL~IMITREX~GLAXOSMITHKLINE~EQ 100MG BASE~N~020132
~001~AB~Jun 1, 1995~Yes~RX~GLAXOSMITHKLINE
LOPERAMIDE HYDROCHLORIDE~TABLET;ORAL~IMODIUM A-D~MCNEIL CONS~2MG~N~019860~001~~N
ov 22, 1989~Yes~OTC~MCNEIL CONSUMER HEALTHCARE
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE~TABLET;ORAL~IMODIUM MULTI-SYMPTOM RELIEF~M
CNEIL CONS~2MG;125MG~N~021140~001~~Nov 30, 2000~Yes~OTC~MCNEIL CONSUMER HEALTHCA
RE
AZATHIOPRINE~TABLET;ORAL~IMURAN~PROMETHEUS LABS~25MG~N~016324~002~~Approved Prio
r to Jan 1, 1982~No~DISCN~PROMETHEUS LABORATORIES INC

AZATHIOPRINE~TABLET;ORAL~IMURAN~PROMETHEUS LABS~50MG~N~016324~001~AB~Approved Pr
ior to Jan 1, 1982~Yes~RX~PROMETHEUS LABORATORIES INC
TELAPREVIR~TABLET;ORAL~INCIVEK~VERTEX PHARMS~375MG~N~201917~001~~May 23, 2011~No
~DISCN~VERTEX PHARMACEUTICALS INC
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~ACTAVIS ELIZABETH~1.25MG~A~074722~001~AB~Jun 1
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~ACTAVIS ELIZABETH~2.5MG~A~074722~002~AB~Jun 17
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~AMERIGEN PHARMS LTD~1.25MG~A~075201~001~~Dec 4
, 1998~No~DISCN~AMERIGEN PHARMACEUTICALS LTD
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~AMERIGEN PHARMS LTD~2.5MG~A~075201~002~~Dec 4,
1998~No~DISCN~AMERIGEN PHARMACEUTICALS LTD
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~IVAX SUB TEVA PHARMS~1.25MG~A~074299~002~AB~Ap
r 29, 1996~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~IVAX SUB TEVA PHARMS~2.5MG~A~074299~001~AB~Jul
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~MYLAN~1.25MG~A~074461~002~AB~Mar 26, 1997~No~R
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~MYLAN~2.5MG~A~074461~001~AB~Mar 27, 1996~Yes~R
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~MYLAN PHARMS INC~1.25MG~A~075105~001~AB~Jul 23
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~MYLAN PHARMS INC~2.5MG~A~075105~002~AB~Jul 23,
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~SANDOZ~1.25MG~A~074594~001~~May 23, 1996~No~DI
SCN~SANDOZ INC
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~SANDOZ~2.5MG~A~074594~002~~May 23, 1996~No~DIS
CN~SANDOZ INC
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~TEVA~1.25MG~A~074498~002~~Feb 12, 1998~No~DISC
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~TEVA~1.25MG~A~074665~001~~Apr 4, 1997~No~DISCN
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~TEVA~2.5MG~A~074498~001~~Oct 31, 1996~No~DISCN
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~TEVA~2.5MG~A~074665~002~~Apr 4, 1997~No~DISCN~
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~WATSON LABS~1.25MG~A~074585~001~~Sep 26, 1996~
INDAPAMIDE~TABLET;ORAL~INDAPAMIDE~WATSON LABS~2.5MG~A~074585~002~~Sep 26, 1996~N
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~INDERAL~WYETH PHARMS INC~10MG~N~016418~001
~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICALS INC
~~Oct 18, 1982~No~DISCN~WYETH PHARMACEUTICALS INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~INDERAL~WYETH PHARMS INC~80MG **Federal Re
r efficacy reasons**~N~016418~004~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH
PHARMACEUTICALS INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~INDERAL~WYETH PHARMS INC~90MG **Federal Re
r efficacy reasons**~N~016418~010~~Oct 18, 1982~No~DISCN~WYETH PHARMACEUTICALS I
NC
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~INDERIDE-40/25~WYETH
PHARMS INC~25MG;40MG~N~018031~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~WYETH
PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~INDERIDE-80/25~WYETH

PHARMS INC~25MG;80MG~N~018031~002~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH
PHARMACEUTICALS INC
ISONIAZID~TABLET;ORAL~INH~NOVARTIS~300MG~A~080935~001~~Approved Prior to Jan 1,
AXITINIB~TABLET;ORAL~INLYTA~PFIZER~1MG~N~202324~001~~Jan 27, 2012~No~RX~PFIZER I
NC
AXITINIB~TABLET;ORAL~INLYTA~PFIZER~5MG~N~202324~002~~Jan 27, 2012~Yes~RX~PFIZER
INC
ESTRADIOL~TABLET;ORAL~INNOFEM~NOVO NORDISK INC~0.5MG~A~040312~001~~Nov 19, 1999~
No~DISCN~NOVO NORDISK INC
ESTRADIOL~TABLET;ORAL~INNOFEM~NOVO NORDISK INC~1MG~A~040312~002~~Nov 19, 1999~No
~DISCN~NOVO NORDISK INC
ESTRADIOL~TABLET;ORAL~INNOFEM~NOVO NORDISK INC~2MG~A~040312~003~~Nov 19, 1999~No
~DISCN~NOVO NORDISK INC
EPLERENONE~TABLET;ORAL~INSPRA~GD SEARLE LLC~25MG~N~021437~001~AB~Sep 27, 2002~No
~RX~GD SEARLE LLC
EPLERENONE~TABLET;ORAL~INSPRA~GD SEARLE LLC~50MG~N~021437~002~AB~Sep 27, 2002~Ye
s~RX~GD SEARLE LLC
EPLERENONE~TABLET;ORAL~INSPRA~GD SEARLE LLC~100MG~N~021437~003~~Sep 27, 2002~No~
DISCN~GD SEARLE LLC
ETRAVIRINE~TABLET;ORAL~INTELENCE~JANSSEN R AND D~25MG~N~022187~003~~Mar 26, 2012
~No~RX~JANSSEN RESEARCH AND DEVELOPMENT LLC
ETRAVIRINE~TABLET;ORAL~INTELENCE~JANSSEN R AND D~100MG~N~022187~001~~Jan 18, 200
8~No~RX~JANSSEN RESEARCH AND DEVELOPMENT LLC
ETRAVIRINE~TABLET;ORAL~INTELENCE~JANSSEN R AND D~200MG~N~022187~002~~Dec 22, 201
0~Yes~RX~JANSSEN RESEARCH AND DEVELOPMENT LLC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~INTROVALE~SANDOZ~0.03MG;0.15MG~A~0
79064~001~AB~Sep 27, 2010~No~RX~SANDOZ INC
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE~TABLET;ORAL~INVAGESIC~SANDOZ~385MG;30MG;
25MG~A~074817~001~~Nov 27, 1996~No~DISCN~SANDOZ INC
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE~TABLET;ORAL~INVAGESIC FORTE~SANDOZ~770MG
;60MG;50MG~A~074817~002~~Nov 27, 1996~No~DISCN~SANDOZ INC
MECAMYLAMINE HYDROCHLORIDE~TABLET;ORAL~INVERSINE~TARGACEPT~2.5MG~N~010251~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~TARGACEPT INC
SAQUINAVIR MESYLATE~TABLET;ORAL~INVIRASE~HOFFMAN LA ROCHE~EQ 500MG BASE~N~021785
~001~~Dec 17, 2004~Yes~RX~HOFFMAN LA ROCHE INC
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE~TABLET;ORAL~INVOKAMET~JANSSEN PHARMS~50MG
;500MG~N~204353~001~~Aug 8, 2014~No~RX~JANSSEN PHARMACEUTICALS INC
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE~TABLET;ORAL~INVOKAMET~JANSSEN PHARMS~50MG
;1GM~N~204353~002~~Aug 8, 2014~No~RX~JANSSEN PHARMACEUTICALS INC
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE~TABLET;ORAL~INVOKAMET~JANSSEN PHARMS~150M
G;500MG~N~204353~003~~Aug 8, 2014~No~RX~JANSSEN PHARMACEUTICALS INC
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE~TABLET;ORAL~INVOKAMET~JANSSEN PHARMS~150M
G;1GM~N~204353~004~~Aug 8, 2014~Yes~RX~JANSSEN PHARMACEUTICALS INC
CANAGLIFLOZIN~TABLET;ORAL~INVOKANA~JANSSEN PHARMS~100MG~N~204042~001~~Mar 29, 20
CANAGLIFLOZIN~TABLET;ORAL~INVOKANA~JANSSEN PHARMS~300MG~N~204042~002~~Mar 29, 20
POTASSIUM IODIDE~TABLET;ORAL~IOSAT~ANBEX~65MG~N~018664~002~~May 12, 2011~No~OTC~
ANBEX INC
POTASSIUM IODIDE~TABLET;ORAL~IOSAT~ANBEX~130MG~N~018664~001~~Oct 14, 1982~Yes~OT
C~ANBEX INC
IRBESARTAN~TABLET;ORAL~IRBESARTAN~ALEMBIC PHARMS LTD~75MG~A~091236~001~AB~Oct 15
5, 2012~No~RX~ALEMBIC PHARMACEUTICALS LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~APOTEX INC~75MG~A~200832~001~AB~Oct 15, 2012~N
o~RX~APOTEX INC
IRBESARTAN~TABLET;ORAL~IRBESARTAN~APOTEX INC~150MG~A~200832~002~AB~Oct 15, 2012~
No~RX~APOTEX INC
IRBESARTAN~TABLET;ORAL~IRBESARTAN~APOTEX INC~300MG~A~200832~003~AB~Oct 15, 2012~
No~RX~APOTEX INC
IRBESARTAN~TABLET;ORAL~IRBESARTAN~AUROBINDO PHARMA LTD~75MG~A~203081~001~AB~Sep
IRBESARTAN~TABLET;ORAL~IRBESARTAN~CIPLA LTD~75MG~A~077205~001~AB~Nov 14, 2012~No
~RX~CIPLA LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~CIPLA LTD~150MG~A~077205~002~AB~Nov 14, 2012~N
o~RX~CIPLA LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~CIPLA LTD~300MG~A~077205~003~AB~Nov 14, 2012~N
o~RX~CIPLA LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~DR REDDYS LABS LTD~75MG~A~203161~001~AB~Sep 27
IRBESARTAN~TABLET;ORAL~IRBESARTAN~HETERO LABS LTD V~75MG~A~202910~001~AB~Sep 27,
IRBESARTAN~TABLET;ORAL~IRBESARTAN~HETERO LABS LTD V~150MG~A~202910~002~AB~Sep 27
, 2012~No~RX~HETERO LABS LTD UNIT V
IRBESARTAN~TABLET;ORAL~IRBESARTAN~HETERO LABS LTD V~300MG~A~202910~003~AB~Sep 27
, 2012~No~RX~HETERO LABS LTD UNIT V
IRBESARTAN~TABLET;ORAL~IRBESARTAN~JUBILANT GENERICS~75MG~A~203534~001~AB~Feb 23,
2015~No~RX~JUBILANT GENERICS LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~JUBILANT GENERICS~150MG~A~203534~002~AB~Feb 23
, 2015~No~RX~JUBILANT GENERICS LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~JUBILANT GENERICS~300MG~A~203534~003~AB~Feb 23
, 2015~No~RX~JUBILANT GENERICS LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~LUPIN LTD~75MG~A~201531~001~AB~Oct 15, 2012~No
~RX~LUPIN LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~LUPIN LTD~150MG~A~201531~002~AB~Oct 15, 2012~N
o~RX~LUPIN LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~LUPIN LTD~300MG~A~201531~003~AB~Oct 15, 2012~N
o~RX~LUPIN LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~MACLEODS PHARMS LTD~75MG~A~202254~001~AB~Oct 3
, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
IRBESARTAN~TABLET;ORAL~IRBESARTAN~MACLEODS PHARMS LTD~150MG~A~202254~002~AB~Oct
IRBESARTAN~TABLET;ORAL~IRBESARTAN~MACLEODS PHARMS LTD~300MG~A~202254~003~AB~Oct
IRBESARTAN~TABLET;ORAL~IRBESARTAN~MYLAN PHARMS INC~75MG~A~200461~001~AB~Sep 27,
IRBESARTAN~TABLET;ORAL~IRBESARTAN~PRINSTON INC~75MG~A~203071~001~AB~Sep 27, 2012
~No~RX~PRINSTON PHARMACEUTICAL INC
2~No~RX~PRINSTON PHARMACEUTICAL INC
IRBESARTAN~TABLET;ORAL~IRBESARTAN~ROXANE~75MG~A~090201~001~AB~Oct 15, 2012~No~RX

IRBESARTAN~TABLET;ORAL~IRBESARTAN~ROXANE~150MG~A~090201~002~AB~Oct 15, 2012~No~R
IRBESARTAN~TABLET;ORAL~IRBESARTAN~ROXANE~300MG~A~090201~003~AB~Oct 15, 2012~No~R
IRBESARTAN~TABLET;ORAL~IRBESARTAN~SANDOZ~75MG~A~077466~001~AB~Sep 27, 2012~No~RX
~SANDOZ INC
IRBESARTAN~TABLET;ORAL~IRBESARTAN~SANDOZ~150MG~A~077466~002~AB~Sep 27, 2012~No~R
X~SANDOZ INC
IRBESARTAN~TABLET;ORAL~IRBESARTAN~SANDOZ~300MG~A~077466~003~AB~Sep 27, 2012~No~R
X~SANDOZ INC
IRBESARTAN~TABLET;ORAL~IRBESARTAN~TEVA PHARMS~75MG~A~077159~001~AB~Mar 30, 2012~
IRBESARTAN~TABLET;ORAL~IRBESARTAN~TEVA PHARMS~150MG~A~077159~002~AB~Mar 30, 2012
IRBESARTAN~TABLET;ORAL~IRBESARTAN~TEVA PHARMS~300MG~A~077159~003~AB~Mar 30, 2012
IRBESARTAN~TABLET;ORAL~IRBESARTAN~WATSON LABS INC~75MG~A~090720~001~AB~Oct 12, 2
IRBESARTAN~TABLET;ORAL~IRBESARTAN~WATSON LABS INC~150MG~A~090720~002~AB~Oct 12,
IRBESARTAN~TABLET;ORAL~IRBESARTAN~WATSON LABS INC~300MG~A~090720~003~AB~Oct 12,
IRBESARTAN~TABLET;ORAL~IRBESARTAN~ZYDUS PHARMS USA INC~75MG~A~079213~001~AB~Sep
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~A
LEMBIC LTD~12.5MG;150MG~A~091370~001~AB~Oct 15, 2012~No~RX~ALEMBIC LTD
LEMBIC LTD~12.5MG;300MG~A~091370~002~AB~Oct 15, 2012~No~RX~ALEMBIC LTD
POTEX INC~12.5MG;150MG~A~201505~001~AB~Oct 15, 2012~No~RX~APOTEX INC
POTEX INC~12.5MG;300MG~A~201505~002~AB~Oct 15, 2012~No~RX~APOTEX INC
UROBINDO PHARMA LTD~12.5MG;150MG~A~203630~001~AB~Feb 22, 2013~No~RX~AUROBINDO PH
ARMA LTD
UROBINDO PHARMA LTD~12.5MG;300MG~A~203630~002~AB~Feb 22, 2013~No~RX~AUROBINDO PH
ARMA LTD
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~D
R REDDYS LABS LTD~12.5MG;150MG~A~203500~001~AB~Sep 27, 2012~No~RX~DR REDDYS LABO
RATORIES LTD
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~D
R REDDYS LABS LTD~12.5MG;300MG~A~203500~002~AB~Sep 27, 2012~No~RX~DR REDDYS LABO
RATORIES LTD
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~L
UPIN LTD~12.5MG;150MG~A~201524~001~AB~Feb 27, 2013~No~RX~LUPIN LTD
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~L
UPIN LTD~12.5MG;300MG~A~201524~002~AB~Feb 27, 2013~No~RX~LUPIN LTD
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~M
ACLEODS PHARMS LTD~12.5MG;150MG~A~202414~001~AB~Sep 27, 2012~No~RX~MACLEODS PHAR
MACEUTICALS LTD
ACLEODS PHARMS LTD~12.5MG;300MG~A~202414~002~AB~Sep 27, 2012~No~RX~MACLEODS PHAR
MACEUTICALS LTD
YLAN PHARMS INC~12.5MG;150MG~A~077969~001~AB~Sep 27, 2012~No~RX~MYLAN PHARMACEUT

ICALS INC
YLAN PHARMS INC~12.5MG;300MG~A~077969~002~AB~Sep 27, 2012~No~RX~MYLAN PHARMACEUT
ICALS INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~P
RINSTON INC~12.5MG;150MG~A~203072~001~AB~May 9, 2014~No~RX~PRINSTON PHARMACEUTIC
AL INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~P
RINSTON INC~12.5MG;300MG~A~203072~002~AB~May 9, 2014~No~RX~PRINSTON PHARMACEUTIC
AL INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~R
OXANE~12.5MG;150MG~A~090351~001~AB~Oct 15, 2012~No~RX~ROXANE LABORATORIES INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~R
OXANE~12.5MG;300MG~A~090351~002~AB~Oct 15, 2012~No~RX~ROXANE LABORATORIES INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~S
ANDOZ~12.5MG;150MG~A~077446~001~AB~Sep 27, 2012~No~RX~SANDOZ INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~S
ANDOZ~12.5MG;300MG~A~077446~002~AB~Sep 27, 2012~No~RX~SANDOZ INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~T
EVA~12.5MG;150MG~A~077369~001~AB~Mar 30, 2012~No~RX~TEVA PHARMACEUTICALS USA INC
EVA~12.5MG;300MG~A~077369~002~AB~Mar 30, 2012~No~RX~TEVA PHARMACEUTICALS USA INC
EVA~25MG;300MG~A~077369~003~~Mar 30, 2012~No~DISCN~TEVA PHARMACEUTICALS USA INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~W
ATSON LABS INC~12.5MG;150MG~A~091539~001~AB~Oct 22, 2012~No~RX~WATSON LABORATORI
ES INC
HYDROCHLOROTHIAZIDE; IRBESARTAN~TABLET;ORAL~IRBESARTAN AND HYDROCHLOROTHIAZIDE~W
ATSON LABS INC~12.5MG;300MG~A~091539~002~AB~Oct 22, 2012~No~RX~WATSON LABORATORI
ES INC
GEFITINIB~TABLET;ORAL~IRESSA~ASTRAZENECA~250MG~N~021399~001~~May 5, 2003~No~DISC
N~ASTRAZENECA UK LTD
RALTEGRAVIR POTASSIUM~TABLET;ORAL~ISENTRESS~MERCK SHARP DOHME~EQ 400MG BASE~N~02
2145~001~~Oct 12, 2007~Yes~RX~MERCK SHARP AND DOHME CORP
GUANETHIDINE MONOSULFATE~TABLET;ORAL~ISMELIN~NOVARTIS~EQ 10MG SULFATE~N~012329~0
GUANETHIDINE MONOSULFATE~TABLET;ORAL~ISMELIN~NOVARTIS~EQ 25MG SULFATE~N~012329~0
ISOSORBIDE MONONITRATE~TABLET;ORAL~ISMO~PROMIUS PHARMA~20MG~N~019091~001~~Dec 30
, 1991~No~DISCN~PROMIUS PHARMA LLC
ISONIAZID~TABLET;ORAL~ISONIAZID~BARR~100MG~A~080936~001~AA~Approved Prior to Jan
ISONIAZID~TABLET;ORAL~ISONIAZID~BARR~300MG~A~080937~002~AA~Approved Prior to Jan
ISONIAZID~TABLET;ORAL~ISONIAZID~DURAMED PHARMS BARR~100MG~A~088231~001~~Mar 17,
ISONIAZID~TABLET;ORAL~ISONIAZID~DURAMED PHARMS BARR~300MG~A~088119~001~~Mar 17,
ISONIAZID~TABLET;ORAL~ISONIAZID~HALSEY~50MG~A~083632~001~~Approved Prior to Jan
ISONIAZID~TABLET;ORAL~ISONIAZID~HIKMA INTL PHARMS~100MG~A~080212~001~~Approved P
rior to Jan 1, 1982~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
ISONIAZID~TABLET;ORAL~ISONIAZID~HIKMA INTL PHARMS~300MG~A~087425~001~~Approved P
rior to Jan 1, 1982~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
ISONIAZID~TABLET;ORAL~ISONIAZID~IMPAX LABS~100MG~A~080153~001~~Approved Prior to
ISONIAZID~TABLET;ORAL~ISONIAZID~IVAX SUB TEVA PHARMS~100MG~A~080270~001~~Approve
S USA
ISONIAZID~TABLET;ORAL~ISONIAZID~IVAX SUB TEVA PHARMS~300MG~A~083610~001~~Approve

S USA
ISONIAZID~TABLET;ORAL~ISONIAZID~LILLY~100MG~N~008499~002~~Approved Prior to Jan
ISONIAZID~TABLET;ORAL~ISONIAZID~LILLY~300MG~N~008499~003~~Approved Prior to Jan
ISONIAZID~TABLET;ORAL~ISONIAZID~MIKART~100MG~A~040090~001~~Jun 26, 1997~No~DISCN
~MIKART INC
ISONIAZID~TABLET;ORAL~ISONIAZID~MIKART~300MG~A~040090~002~~Jun 26, 1997~No~DISCN
~MIKART INC
ISONIAZID~TABLET;ORAL~ISONIAZID~MK LABS~100MG~A~080941~001~~Approved Prior to Ja
ISONIAZID~TABLET;ORAL~ISONIAZID~MUTUAL PHARM~100MG~A~080136~001~~Approved Prior
to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
ISONIAZID~TABLET;ORAL~ISONIAZID~MUTUAL PHARM~300MG~A~083633~001~~Approved Prior
ISONIAZID~TABLET;ORAL~ISONIAZID~NEXGEN PHARMA INC~100MG~A~084050~001~~Approved P
rior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
ISONIAZID~TABLET;ORAL~ISONIAZID~PANRAY~50MG~N~008428~001~~Approved Prior to Jan
1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
ISONIAZID~TABLET;ORAL~ISONIAZID~PERRIGO~100MG~A~083060~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~L PERRIGO CO
ISONIAZID~TABLET;ORAL~ISONIAZID~PHARMAVITE~100MG~A~085091~001~~Approved Prior to
Jan 1, 1982~No~DISCN~PHARMAVITE PHARMACEUTICALS
ISONIAZID~TABLET;ORAL~ISONIAZID~PHOENIX LABS NY~50MG~A~080368~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~PHOENIX LABORATORIES INC
ISONIAZID~TABLET;ORAL~ISONIAZID~PHOENIX LABS NY~100MG~A~080368~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~PHOENIX LABORATORIES INC
ISONIAZID~TABLET;ORAL~ISONIAZID~PUREPAC PHARM~50MG~A~080132~003~~Jul 14, 1982~No
ISONIAZID~TABLET;ORAL~ISONIAZID~PUREPAC PHARM~100MG~A~080132~004~~Jul 14, 1982~N
ISONIAZID~TABLET;ORAL~ISONIAZID~SANDOZ~100MG~N~008678~002~AA~Approved Prior to J
an 1, 1982~Yes~RX~SANDOZ INC
ISONIAZID~TABLET;ORAL~ISONIAZID~SANDOZ~300MG~N~008678~003~AA~Approved Prior to J
an 1, 1982~Yes~RX~SANDOZ INC
ISONIAZID~TABLET;ORAL~ISONIAZID~THEPHARMANETWORK LLC~100MG~A~202610~001~AA~Oct 2
ISONIAZID~TABLET;ORAL~ISONIAZID~THEPHARMANETWORK LLC~300MG~A~202610~002~AA~Oct 2
ISONIAZID~TABLET;ORAL~ISONIAZID~WATSON LABS~50MG~A~080522~001~~Approved Prior to
Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
ISONIAZID~TABLET;ORAL~ISONIAZID~WATSON LABS~100MG~A~080401~001~~Approved Prior t
ISONIAZID~TABLET;ORAL~ISONIAZID~WHITEWORTH TOWN PLSN~100MG~A~080120~002~~Approve

VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~ISOPTIN~FSC~40MG~N~018593~003~~Nov 23, 1987~
No~DISCN~FSC LABORATORIES INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~ISOPTIN~FSC~80MG~N~018593~001~~Mar 8, 1982~N
o~DISCN~FSC LABORATORIES INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~ISOPTIN~FSC~120MG~N~018593~002~~Mar 8, 1982~
No~DISCN~FSC LABORATORIES INC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISORDIL~VALEANT PHARMS NORTH~5MG~N~012093~007~A
B~Jul 29, 1988~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISORDIL~VALEANT PHARMS NORTH~10MG~N~012093~002~
~Jul 29, 1988~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~HIKMA INTL PHARMS~5MG~A~08
6067~001~AB~Oct 29, 1987~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
86066~001~AB~Oct 29, 1987~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
88088~001~AB~Nov 2, 1987~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
40591~001~AB~Jan 10, 2007~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~MUTUAL PHARM~5MG~A~086166~
002~~Sep 19, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~MUTUAL PHARM~10MG~A~086169
~001~~Sep 19, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~PAR PHARM~5MG~A~086923~001
~AB~Mar 12, 1987~No~RX~PAR PHARMACEUTICAL INC
1~AB~Mar 12, 1987~No~RX~PAR PHARMACEUTICAL INC
1~AB~Oct 2, 1987~No~RX~PAR PHARMACEUTICAL INC
1~AB~Jan 12, 1988~Yes~RX~PAR PHARMACEUTICAL INC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~SANDOZ~5MG~A~086221~001~AB
~Jan 7, 1988~No~RX~SANDOZ INC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~SANDOZ~10MG~A~086223~001~A
B~Jan 7, 1988~No~RX~SANDOZ INC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~SANDOZ~20MG~A~089367~001~A
B~Apr 7, 1988~No~RX~SANDOZ INC
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~SUPERPHARM~5MG~A~089190~00
1~~Feb 17, 1987~No~DISCN~SUPERPHARM CORP
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~WATSON LABS~5MG~A~086034~0
ISOSORBIDE DINITRATE~TABLET;ORAL~ISOSORBIDE DINITRATE~WATSON LABS~10MG~A~086032~
ISOSORBIDE MONONITRATE~TABLET;ORAL~ISOSORBIDE MONONITRATE~ACTAVIS ELIZABETH~10MG
~A~075037~002~AB~Oct 30, 1998~No~RX~ACTAVIS ELIZABETH LLC
ISOSORBIDE MONONITRATE~TABLET;ORAL~ISOSORBIDE MONONITRATE~ACTAVIS ELIZABETH~20MG
~A~075037~001~AB~Oct 30, 1998~No~RX~ACTAVIS ELIZABETH LLC

ISOSORBIDE MONONITRATE~TABLET;ORAL~ISOSORBIDE MONONITRATE~ANI PHARMS INC~20MG~A~
075147~001~AB~Nov 27, 1998~No~RX~ANI PHARMACEUTICALS INC
ISOSORBIDE MONONITRATE~TABLET;ORAL~ISOSORBIDE MONONITRATE~HIKMA PHARMS LLC~20MG~
A~075361~001~AB~Oct 5, 2000~No~RX~HIKMA PHARMACEUTICALS LLC
IVERMECTIN~TABLET;ORAL~IVERMECTIN~EDENBRIDGE PHARMS~3MG~A~204154~001~AB~Oct 24,
2014~No~RX~EDENBRIDGE PHARMACEUTICALS LLC
RUXOLITINIB PHOSPHATE~TABLET;ORAL~JAKAFI~INCYTE CORP~EQ 5MG BASE~N~202192~001~~N
ov 16, 2011~No~RX~INCYTE CORP
RUXOLITINIB PHOSPHATE~TABLET;ORAL~JAKAFI~INCYTE CORP~EQ 10MG BASE~N~202192~002~~
Nov 16, 2011~No~RX~INCYTE CORP
Nov 16, 2011~Yes~RX~INCYTE CORP
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~JANIMINE~ABBOTT~10MG~N~017895~001~~Approved
WARFARIN SODIUM~TABLET;ORAL~JANTOVEN~USL PHARMA~1MG~A~040416~001~AB~Oct 2, 2003~
No~RX~USL PHARMA INC
WARFARIN SODIUM~TABLET;ORAL~JANTOVEN~USL PHARMA~2.5MG~A~040416~003~AB~Oct 2, 200
3~No~RX~USL PHARMA INC
WARFARIN SODIUM~TABLET;ORAL~JANTOVEN~USL PHARMA~7.5MG~A~040416~008~AB~Oct 2, 200
3~No~RX~USL PHARMA INC
WARFARIN SODIUM~TABLET;ORAL~JANTOVEN~USL PHARMA~10MG~A~040416~009~AB~Oct 2, 2003
~No~RX~USL PHARMA INC
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE~TABLET;ORAL~JANUMET~MERCK SHARP D
OHME~1GM;EQ 50MG BASE~N~022044~002~~Mar 30, 2007~Yes~RX~MERCK SHARP AND DOHME CO
RP
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE~TABLET;ORAL~JANUMET~MERCK SHARP D
OHME~500MG;EQ 50MG BASE~N~022044~001~~Mar 30, 2007~No~RX~MERCK SHARP AND DOHME C
ORP
SITAGLIPTIN PHOSPHATE~TABLET;ORAL~JANUVIA~MERCK SHARP DOHME~EQ 25MG BASE~N~02199
5~001~~Oct 16, 2006~No~RX~MERCK SHARP AND DOHME CORP
5~002~~Oct 16, 2006~No~RX~MERCK SHARP AND DOHME CORP
95~003~~Oct 16, 2006~Yes~RX~MERCK SHARP AND DOHME CORP
EMPAGLIFLOZIN~TABLET;ORAL~JARDIANCE~BOEHRINGER INGELHEIM~10MG~N~204629~001~~Aug
1, 2014~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
EMPAGLIFLOZIN~TABLET;ORAL~JARDIANCE~BOEHRINGER INGELHEIM~25MG~N~204629~002~~Aug
LINAGLIPTIN; METFORMIN HYDROCHLORIDE~TABLET;ORAL~JENTADUETO~BOEHRINGER INGELHEIM
~2.5MG;1GM~N~201281~003~~Jan 30, 2012~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICAL
S INC

~2.5MG;500MG~N~201281~001~~Jan 30, 2012~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICA
LS INC
~2.5MG;850MG~N~201281~002~~Jan 30, 2012~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICA
LS INC
IBUPROFEN~TABLET;ORAL~JUNIOR STRENGTH ADVIL~PFIZER~100MG~N~020267~002~~Dec 13, 1
996~No~OTC~PFIZER INC
IBUPROFEN~TABLET;ORAL~JUNIOR STRENGTH IBUPROFEN~PERRIGO~100MG~A~075367~001~~Apr
22, 1999~No~OTC~PERRIGO CO
IBUPROFEN~TABLET;ORAL~JUNIOR STRENGTH MOTRIN~MCNEIL CONS~100MG~N~020602~001~~Jun
10, 1996~No~OTC~MCNEIL CONSUMER HEALTHCARE
SIMVASTATIN; SITAGLIPTIN PHOSPHATE~TABLET;ORAL~JUVISYNC~MERCK SHARP DOHME~10MG;E
Q 50MG BASE~N~202343~004~~Sep 18, 2012~No~DISCN~MERCK SHARP AND DOHME CORP
Q 100MG BASE~N~202343~001~~Oct 7, 2011~No~DISCN~MERCK SHARP AND DOHME CORP
LOPINAVIR; RITONAVIR~TABLET;ORAL~KALETRA~ABBVIE~100MG;25MG~N~021906~002~~Nov 9,
2007~No~RX~ABBVIE INC
LOPINAVIR; RITONAVIR~TABLET;ORAL~KALETRA~ABBVIE~200MG;50MG~N~021906~001~~Oct 28,
IVACAFTOR~TABLET;ORAL~KALYDECO~VERTEX PHARMS~150MG~N~203188~001~~Jan 31, 2012~Ye
s~RX~VERTEX PHARMACEUTICALS INC
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE~TABLET;ORAL~KAZANO~TAKEDA PHARMS US
A~EQ 12.5MG BASE;1GM~N~203414~002~~Jan 25, 2013~Yes~RX~TAKEDA PHARMACEUTICALS US
A INC
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE~TABLET;ORAL~KAZANO~TAKEDA PHARMS US
A~EQ 12.5MG BASE;500MG~N~203414~001~~Jan 25, 2013~No~RX~TAKEDA PHARMACEUTICALS U
SA INC
CEPHALEXIN~TABLET;ORAL~KEFLET~LILLY~EQ 1GM BASE~N~050440~002~~Approved Prior to
CEPHALEXIN~TABLET;ORAL~KEFLET~LILLY~EQ 250MG BASE~A~062745~001~~Dec 1, 1986~No~D
ISCN~ELI LILLY AND CO
CEPHALEXIN~TABLET;ORAL~KEFLET~LILLY~EQ 250MG BASE~N~050440~003~~Feb 26, 1987~No~
DISCN~ELI LILLY AND CO
CEPHALEXIN~TABLET;ORAL~KEFLET~LILLY~EQ 500MG BASE~A~062745~002~~Dec 1, 1986~No~D
ISCN~ELI LILLY AND CO
CEPHALEXIN~TABLET;ORAL~KEFLET~LILLY~EQ 500MG BASE~N~050440~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~ELI LILLY AND CO
CEPHALEXIN HYDROCHLORIDE~TABLET;ORAL~KEFTAB~LILLY~EQ 250MG BASE~N~050614~001~~Oc
t 29, 1987~No~DISCN~ELI LILLY AND CO
CEPHALEXIN HYDROCHLORIDE~TABLET;ORAL~KEFTAB~LILLY~EQ 333MG BASE~N~050614~003~~Ma
y 16, 1988~No~DISCN~ELI LILLY AND CO
CEPHALEXIN HYDROCHLORIDE~TABLET;ORAL~KEFTAB~LILLY~EQ 500MG BASE~N~050614~002~~Oc
t 29, 1987~No~DISCN~ELI LILLY AND CO
PROCYCLIDINE HYDROCHLORIDE~TABLET;ORAL~KEMADRIN~MONARCH PHARMS~2MG~N~009818~005~
~Approved Prior to Jan 1, 1982~No~DISCN~MONARCH PHARMACEUTICALS INC
PROCYCLIDINE HYDROCHLORIDE~TABLET;ORAL~KEMADRIN~MONARCH PHARMS~5MG~N~009818~003~
~Approved Prior to Jan 1, 1982~No~DISCN~MONARCH PHARMACEUTICALS INC
TRIAMCINOLONE~TABLET;ORAL~KENACORT~DELCOR ASSET CORP~1MG~N~011283~003~~Approved
Prior to Jan 1, 1982~No~DISCN~DELCOR ASSET CORP

LEVETIRACETAM~TABLET;ORAL~KEPPRA~UCB INC~1GM~N~021035~004~AB~Jan 6, 2006~Yes~RX~
UCB INC
LEVETIRACETAM~TABLET;ORAL~KEPPRA~UCB INC~250MG~N~021035~001~AB~Nov 30, 1999~No~R
X~UCB INC
X~UCB INC
X~UCB INC
BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE~TABLET;ORAL~KERLEDEX~SANOFI AVENTIS US~5
MG;12.5MG~N~019807~001~~Oct 30, 1992~No~DISCN~SANOFI AVENTIS US LLC
BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE~TABLET;ORAL~KERLEDEX~SANOFI AVENTIS US~1
0MG;12.5MG~N~019807~002~~Oct 30, 1992~No~DISCN~SANOFI AVENTIS US LLC
BETAXOLOL HYDROCHLORIDE~TABLET;ORAL~KERLONE~SANOFI AVENTIS US~10MG~N~019507~001~
~Oct 27, 1989~No~DISCN~SANOFI AVENTIS US LLC
BETAXOLOL HYDROCHLORIDE~TABLET;ORAL~KERLONE~SANOFI AVENTIS US~20MG~N~019507~002~
~Oct 27, 1989~No~DISCN~SANOFI AVENTIS US LLC
TELITHROMYCIN~TABLET;ORAL~KETEK~SANOFI AVENTIS US~300MG~N~021144~002~~Feb 9, 200
TELITHROMYCIN~TABLET;ORAL~KETEK~SANOFI AVENTIS US~400MG~N~021144~001~~Apr 1, 200
KETOCONAZOLE~TABLET;ORAL~KETOCONAZOLE~AAIPHARMA LLC~200MG~A~075341~001~~Jul 27,
1999~No~DISCN~AAIPHARMA LLC
KETOCONAZOLE~TABLET;ORAL~KETOCONAZOLE~APOTEX~200MG~A~075912~001~~Jan 10, 2002~No
~DISCN~APOTEX INC
KETOCONAZOLE~TABLET;ORAL~KETOCONAZOLE~MUTUAL PHARMA~200MG~A~075314~001~~Jun 15,
1999~No~DISCN~MUTUAL PHARMACAL CO
KETOCONAZOLE~TABLET;ORAL~KETOCONAZOLE~MYLAN~200MG~A~075597~001~AB~Dec 23, 1999~N
KETOCONAZOLE~TABLET;ORAL~KETOCONAZOLE~PLIVA~200MG~A~075362~001~~Jun 15, 1999~No~
DISCN~PLIVA INC
KETOCONAZOLE~TABLET;ORAL~KETOCONAZOLE~TARO~200MG~A~075319~001~AB~Jun 15, 1999~No
~RX~TARO PHARMACEUTICAL INDUSTRIES LTD
KETOCONAZOLE~TABLET;ORAL~KETOCONAZOLE~TEVA~200MG~A~074971~001~~Jun 15, 1999~No~D
KETOCONAZOLE~TABLET;ORAL~KETOCONAZOLE~TEVA~200MG~A~075273~001~AB~Jun 15, 1999~Ye
KETOPROFEN~TABLET;ORAL~KETOPROFEN~PERRIGO~12.5MG~A~075364~001~~Feb 7, 2002~No~DI
SCN~L PERRIGO CO
KETOROLAC TROMETHAMINE~TABLET;ORAL~KETOROLAC TROMETHAMINE~CYCLE PHARMS LTD~10MG~
A~074790~001~~Jun 26, 1997~No~DISCN~CYCLE PHARMACEUTICALS LTD
KETOROLAC TROMETHAMINE~TABLET;ORAL~KETOROLAC TROMETHAMINE~MYLAN~10MG~A~074761~00
1~AB~May 16, 1997~Yes~RX~MYLAN PHARMACEUTICALS INC
KETOROLAC TROMETHAMINE~TABLET;ORAL~KETOROLAC TROMETHAMINE~PLIVA~10MG~A~075284~00
1~AB~Jun 23, 1999~No~RX~PLIVA INC
KETOROLAC TROMETHAMINE~TABLET;ORAL~KETOROLAC TROMETHAMINE~TEVA~10MG~A~074754~001
~AB~May 16, 1997~No~RX~TEVA PHARMACEUTICALS USA INC
KETOROLAC TROMETHAMINE~TABLET;ORAL~KETOROLAC TROMETHAMINE~WATSON LABS~10MG~A~074
CLONAZEPAM~TABLET;ORAL~KLONOPIN~ROCHE~0.125MG~N~017533~005~~Apr 9, 1997~No~DISCN
CLONAZEPAM~TABLET;ORAL~KLONOPIN~ROCHE~0.25MG~N~017533~006~~Apr 9, 1997~No~DISCN~
CLONAZEPAM~TABLET;ORAL~KLONOPIN~ROCHE~0.5MG~N~017533~001~AB~Approved Prior to Ja
n 1, 1982~No~RX~HOFFMANN LA ROCHE INC
CLONAZEPAM~TABLET;ORAL~KLONOPIN~ROCHE~1MG~N~017533~002~AB~Approved Prior to Jan
1, 1982~Yes~RX~HOFFMANN LA ROCHE INC
CLONAZEPAM~TABLET;ORAL~KLONOPIN~ROCHE~2MG~N~017533~003~AB~Approved Prior to Jan

CHLORPHENIRAMINE MALEATE~TABLET;ORAL~KLOROMIN~HALSEY~4MG~A~083629~001~~Approved
Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~KOGLUCOID~PANRAY~50MG~N~009278~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~KOGLUCOID~PANRAY~100MG~N~009278~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO IN
C
MIFEPRISTONE~TABLET;ORAL~KORLYM~CORCEPT THERAP~300MG~N~202107~001~~Feb 17, 2012~
Yes~RX~CORCEPT THERAPEUTICS INC
SAPROPTERIN DIHYDROCHLORIDE~TABLET;ORAL~KUVAN~BIOMARIN PHARM~100MG~N~022181~001~
~Dec 13, 2007~Yes~RX~BIOMARIN PHARMACEUTICAL INC
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~KYTRIL~ROCHE~EQ 1MG BASE~N~020305~001~~Mar
GRANISETRON HYDROCHLORIDE~TABLET;ORAL~KYTRIL~ROCHE~EQ 2MG BASE~N~020305~002~~Jun
LABETALOL HYDROCHLORIDE~TABLET;ORAL~LABETALOL HYDROCHLORIDE~APOTHECON~100MG~A~07
5223~001~~Nov 20, 1998~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
LABETALOL HYDROCHLORIDE~TABLET;ORAL~LABETALOL HYDROCHLORIDE~IVAX SUB TEVA PHARMS
~100MG~A~074787~001~AB~Aug 3, 1998~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
ACEUTICALS USA
ACEUTICALS USA
LABETALOL HYDROCHLORIDE~TABLET;ORAL~LABETALOL HYDROCHLORIDE~MUTUAL PHARM~100MG~A
LABETALOL HYDROCHLORIDE~TABLET;ORAL~LABETALOL HYDROCHLORIDE~PAR FORM~100MG~A~200
908~001~AB~Jul 10, 2012~No~RX~PAR FORMULATIONS PRIVATE LTD
LABETALOL HYDROCHLORIDE~TABLET;ORAL~LABETALOL HYDROCHLORIDE~SANDOZ~100MG~A~07511
3~002~AB~Aug 4, 1998~Yes~RX~SANDOZ INC
LABETALOL HYDROCHLORIDE~TABLET;ORAL~LABETALOL HYDROCHLORIDE~TEVA~100MG~A~074989~
LABETALOL HYDROCHLORIDE~TABLET;ORAL~LABETALOL HYDROCHLORIDE~WATSON LABS~100MG~A~

LAMOTRIGINE~TABLET;ORAL~LAMICTAL~GLAXOSMITHKLINE LLC~25MG~N~020241~005~AB~Dec 27
, 1994~Yes~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET;ORAL~LAMICTAL~GLAXOSMITHKLINE LLC~50MG~N~020241~006~~Dec 27,
7, 1994~No~RX~GLAXOSMITHKLINE LLC
LAMOTRIGINE~TABLET;ORAL~LAMICTAL~GLAXOSMITHKLINE LLC~250MG~N~020241~004~~Dec 27,
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~LAMISIL~NOVARTIS~EQ 250MG BASE~N~020539~00
1~AB~May 10, 1996~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~APOTEX~150MG~A~091606~001~AB~Dec 2, 2011~No~RX
~APOTEX INC
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~APOTEX~300MG~A~091606~002~AB~Dec 2, 2011~No~RX
~APOTEX INC
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~APOTEX INC~100MG~A~202941~001~AB~Jan 2, 2014~N
o~RX~APOTEX INC
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~AUROBINDO PHARMA LTD~150MG~A~202032~001~AB~Nov
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~AUROBINDO PHARMA LTD~300MG~A~202032~002~AB~Nov
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~HETERO LABS LTD V~100MG~A~203260~001~AB~Jan 2,
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~LUPIN LTD~150MG~A~205217~001~AB~Dec 18, 2014~N
o~RX~LUPIN LTD
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~LUPIN LTD~300MG~A~205217~002~AB~Dec 18, 2014~N
o~RX~LUPIN LTD
LAMIVUDINE~TABLET;ORAL~LAMIVUDINE~MYLAN PHARMS INC~100MG~A~204002~001~AB~Dec 31,
LAMIVUDINE; ZIDOVUDINE~TABLET;ORAL~LAMIVUDINE AND ZIDOVUDINE~AUROBINDO PHARMA LT
D~150MG;300MG~A~202418~001~AB~May 15, 2012~No~RX~AUROBINDO PHARMA LTD
LAMIVUDINE; ZIDOVUDINE~TABLET;ORAL~LAMIVUDINE AND ZIDOVUDINE~HETERO LABS LTD V~1
50MG;300MG~A~203259~001~AB~Feb 3, 2014~No~RX~HETERO LABS LTD UNIT V
LAMIVUDINE; ZIDOVUDINE~TABLET;ORAL~LAMIVUDINE AND ZIDOVUDINE~LUPIN LTD~150MG;300
MG~A~090246~001~AB~May 15, 2012~No~RX~LUPIN LTD
LAMIVUDINE; ZIDOVUDINE~TABLET;ORAL~LAMIVUDINE AND ZIDOVUDINE~MYLAN PHARMS INC~15
0MG;300MG~A~204005~001~AB~Aug 28, 2014~No~RX~MYLAN PHARMACEUTICALS INC
LAMIVUDINE; ZIDOVUDINE~TABLET;ORAL~LAMIVUDINE AND ZIDOVUDINE~TEVA PHARMS~150MG;3
00MG~A~079081~001~AB~May 25, 2011~No~RX~TEVA PHARMACEUTICALS USA
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~ACTAVIS TOTOWA~25MG~A~078669~001~~Apr 8, 201
1~No~DISCN~ACTAVIS TOTOWA LLC
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~ALEMBIC PHARMS LTD~25MG~A~090607~001~AB~Jan

LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~ALKEM LABS LTD~25MG~A~200694~001~AB~Jun 14,
2013~No~RX~ALKEM LABORATORIES LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~APOTEX INC~25MG~A~078625~001~AB~Jan 27, 2009
~No~RX~APOTEX INC
9~No~RX~APOTEX INC
9~No~RX~APOTEX INC
9~No~RX~APOTEX INC
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~AUROBINDO PHARMA~25MG~A~078956~001~AB~Jan 27
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~CADISTA PHARMS~25MG~A~079132~001~AB~Jan 27,
2009~No~RX~CADISTA PHARMACEUTICALS INC
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~CIPLA LTD~25MG~A~077783~001~AB~Nov 1, 2010~N
o~RX~CIPLA LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~CIPLA LTD~100MG~A~077783~002~AB~Nov 1, 2010~
No~RX~CIPLA LTD
No~RX~CIPLA LTD
No~RX~CIPLA LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~DR REDDYS LABS LTD~25MG~A~076708~001~AB~Jan
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~GLENMARK GENERICS~25MG~A~090169~001~AB~May 1
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~GLENMARK GENERICS~100MG~A~090169~002~AB~May
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~HIKMA PHARMS~25MG~A~078134~001~AB~Apr 19, 20

LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~LUPIN LTD~25MG~A~078691~001~AB~Jun 1, 2010~N
o~RX~LUPIN LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~LUPIN LTD~100MG~A~078691~002~AB~Jun 1, 2010~
No~RX~LUPIN LTD
No~RX~LUPIN LTD
No~RX~LUPIN LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~MATRIX LABS LTD~25MG~A~078443~001~~Feb 11, 2
009~No~DISCN~MATRIX LABORATORIES LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~MATRIX LABS LTD~100MG~A~078443~002~~Feb 11,
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~MYLAN~25MG~A~077420~001~AB~Jan 27, 2009~No~R
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~MYLAN~25MG~A~077428~001~~Jan 27, 2009~No~DIS
CN~MYLAN PHARMACEUTICALS INC
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~MYLAN~100MG~A~077420~002~AB~Jan 27, 2009~No~
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~MYLAN~100MG~A~077428~002~~Jan 27, 2009~No~DI
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~PHARMASCIENCE INC~25MG~A~078310~001~~Feb 4,
2009~No~DISCN~PHARMASCIENCE INC
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~ROXANE~25MG~A~077392~001~~Jan 27, 2009~No~DI
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~ROXANE~100MG~A~077392~002~~Jan 27, 2009~No~D
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~SANDOZ~25MG~A~078645~001~~Jan 27, 2009~No~DI
SCN~SANDOZ INC
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~SANDOZ~100MG~A~078645~002~~Jan 27, 2009~No~D
ISCN~SANDOZ INC

ISCN~SANDOZ INC
ISCN~SANDOZ INC
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~TARO PHARM INDS~25MG~A~078525~001~AB~Jan 27,
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~TARO PHARM INDS~100MG~A~078525~002~AB~Jan 27
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~TEVA~25MG~A~076388~001~AB~Aug 30, 2006~No~RX
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~TEVA~100MG~A~076388~002~AB~Aug 30, 2006~No~R
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~TORRENT PHARMS~25MG~A~078947~001~AB~Jan 27,
2009~No~RX~TORRENT PHARMACEUTICALS LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~UNICHEM LABS LTD~25MG~A~090170~001~AB~Oct 6,
2011~No~RX~UNICHEM LABORATORIES LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~UNICHEM LABS LTD~100MG~A~090170~002~AB~Oct 6
, 2011~No~RX~UNICHEM LABORATORIES LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~WOCKHARDT~25MG~A~078982~001~~Jan 27, 2009~No
~DISCN~WOCKHARDT LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~WOCKHARDT~100MG~A~078982~002~~Jan 27, 2009~N
o~DISCN~WOCKHARDT LTD
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~ZYDUS PHARMS USA~25MG~A~077633~001~AB~Jan 27
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~ZYDUS PHARMS USA~50MG~A~077633~002~~Jan 27,
LAMOTRIGINE~TABLET;ORAL~LAMOTRIGINE~ZYDUS PHARMS USA~250MG~A~077633~006~~Jan 27,
ISONIAZID~TABLET;ORAL~LANIAZID~LANNETT~50MG~A~080140~001~~Approved Prior to Jan
1, 1982~No~DISCN~LANNETT CO INC
ISONIAZID~TABLET;ORAL~LANIAZID~LANNETT~100MG~A~080140~002~~Approved Prior to Jan
ISONIAZID~TABLET;ORAL~LANIAZID~LANNETT~300MG~A~089776~001~AA~Jun 13, 1988~No~RX~

LANNETT CO INC
ASPIRIN; BUTALBITAL; CAFFEINE~TABLET;ORAL~LANORINAL~LANNETT~325MG;50MG;40MG~A~08
6986~002~~Oct 18, 1985~No~DISCN~LANNETT CO INC
DIGOXIN~TABLET;ORAL~LANOXIN~COVIS PHARMA~0.0625MG~N~020405~001~~Sep 30, 1997~No~
RX~COVIS PHARMA SARL
DIGOXIN~TABLET;ORAL~LANOXIN~COVIS PHARMA~0.125MG~N~020405~002~AB~Sep 30, 1997~No
~RX~COVIS PHARMA SARL
DIGOXIN~TABLET;ORAL~LANOXIN~COVIS PHARMA~0.1875MG~N~020405~003~~Sep 30, 1997~No~
RX~COVIS PHARMA SARL
DIGOXIN~TABLET;ORAL~LANOXIN~COVIS PHARMA~0.25MG~N~020405~004~AB~Sep 30, 1997~Yes
~RX~COVIS PHARMA SARL
DIGOXIN~TABLET;ORAL~LANOXIN~COVIS PHARMA~0.375MG~N~020405~005~~Sep 30, 1997~No~D
ISCN~COVIS PHARMA SARL
DIGOXIN~TABLET;ORAL~LANOXIN~COVIS PHARMA~0.5MG~N~020405~006~~Sep 30, 1997~No~DIS
CN~COVIS PHARMA SARL
MEFLOQUINE HYDROCHLORIDE~TABLET;ORAL~LARIAM~ROCHE~250MG~N~019591~001~~May 2, 198
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~LARIN 24 FE~NOVAST LABS LTD
~0.02MG;1MG~A~202994~001~AB~Feb 18, 2015~No~RX~NOVAST LABORATORIES LTD
LEVODOPA~TABLET;ORAL~LARODOPA~ROCHE~100MG~N~016912~005~~Approved Prior to Jan 1,
FUROSEMIDE~TABLET;ORAL~LASIX~SANOFI AVENTIS US~20MG~N~016273~002~AB~Approved Pri
or to Jan 1, 1982~No~RX~SANOFI AVENTIS US LLC
or to Jan 1, 1982~No~RX~SANOFI AVENTIS US LLC
or to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
LURASIDONE HYDROCHLORIDE~TABLET;ORAL~LATUDA~SUNOVION PHARMS INC~20MG~N~200603~00
3~~Dec 7, 2011~No~RX~SUNOVION PHARMACEUTICALS INC
1~~Oct 28, 2010~Yes~RX~SUNOVION PHARMACEUTICALS INC
5~~Jul 12, 2013~No~RX~SUNOVION PHARMACEUTICALS INC
2~~Oct 28, 2010~No~RX~SUNOVION PHARMACEUTICALS INC
04~~Apr 26, 2012~No~RX~SUNOVION PHARMACEUTICALS INC
PENICILLIN V POTASSIUM~TABLET;ORAL~LEDERCILLIN VK~LEDERLE~EQ 250MG BASE~A~060134
~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN C
YANAMID CO
PENICILLIN V POTASSIUM~TABLET;ORAL~LEDERCILLIN VK~LEDERLE~EQ 500MG BASE~A~060134
~002~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN C
YANAMID CO
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~ALEMBIC PHARMS LTD~10MG~A~091369~001~AB~Nov
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~ALEMBIC PHARMS LTD~20MG~A~091369~002~AB~Nov
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~APOTEX INC~10MG~A~077090~001~AB~Sep 13, 2005
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~APOTEX INC~20MG~A~077090~002~AB~Sep 13, 2005
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~BARR~10MG~A~077083~001~AB~Sep 13, 2005~No~RX
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~BARR~20MG~A~077083~002~AB~Sep 13, 2005~No~RX
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~HERITAGE PHARMS INC~10MG~A~077086~001~AB~Sep

LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~HERITAGE PHARMS INC~20MG~A~077086~002~AB~Sep
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~SANDOZ~10MG~A~077085~001~~Sep 13, 2005~No~DI
SCN~SANDOZ INC
SCN~SANDOZ INC
SCN~SANDOZ INC
SCN~SANDOZ INC
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~TEVA PHARMS~10MG~A~077084~001~AB~Sep 13, 200
LEFLUNOMIDE~TABLET;ORAL~LEFLUNOMIDE~TEVA PHARMS~20MG~A~077084~002~AB~Sep 13, 200
ANILERIDINE HYDROCHLORIDE~TABLET;ORAL~LERITINE~MERCK~EQ 25MG BASE~N~010585~002~~
AMBRISENTAN~TABLET;ORAL~LETAIRIS~GILEAD~5MG~N~022081~001~~Jun 15, 2007~No~RX~GIL
EAD SCIENCES INC
AMBRISENTAN~TABLET;ORAL~LETAIRIS~GILEAD~10MG~N~022081~002~~Jun 15, 2007~Yes~RX~G
ILEAD SCIENCES INC
LETROZOLE~TABLET;ORAL~LETROZOLE~ACCORD HLTHCARE~2.5MG~A~090934~001~AB~Jun 3, 201
LETROZOLE~TABLET;ORAL~LETROZOLE~ACTAVIS TOTOWA~2.5MG~A~090292~001~~Jul 13, 2011~
No~DISCN~ACTAVIS TOTOWA LLC
LETROZOLE~TABLET;ORAL~LETROZOLE~APOTEX INC~2.5MG~A~091303~001~AB~Apr 19, 2012~No
~RX~APOTEX INC
LETROZOLE~TABLET;ORAL~LETROZOLE~DR REDDYS LABS LTD~2.5MG~A~091191~001~AB~Jun 3,
LETROZOLE~TABLET;ORAL~LETROZOLE~FRESENIUS KABI ONCOL~2.5MG~A~090491~001~AB~Jun 3
, 2011~No~RX~FRESENIUS KABI ONCOLOGY PLC
LETROZOLE~TABLET;ORAL~LETROZOLE~IMPAX LABS~2.5MG~A~091638~001~~Jun 3, 2011~No~DI
SCN~IMPAX LABORATORIES INC
LETROZOLE~TABLET;ORAL~LETROZOLE~INDICUS PHARMA~2.5MG~A~201804~001~AB~Jun 3, 2011
~No~RX~INDICUS PHARMA LLC
LETROZOLE~TABLET;ORAL~LETROZOLE~JIANGSU HENGRUI MED~2.5MG~A~202716~001~AB~May 16
, 2013~No~RX~JIANGSU HENGRUI MEDICINE CO LTD
LETROZOLE~TABLET;ORAL~LETROZOLE~KUDCO IRELAND~2.5MG~A~091098~001~AB~Jun 3, 2011~
No~RX~KUDCO IRELAND LTD
LETROZOLE~TABLET;ORAL~LETROZOLE~LANNETT HOLDINGS INC~2.5MG~A~202048~001~AB~Oct 2
9, 2014~No~RX~LANNETT HOLDINGS INC
LETROZOLE~TABLET;ORAL~LETROZOLE~MYLAN~2.5MG~A~078190~001~AB~Dec 24, 2008~No~RX~M
LETROZOLE~TABLET;ORAL~LETROZOLE~NATCO PHARMA LTD~2.5MG~A~200161~001~AB~Jun 3, 20
11~No~RX~NATCO PHARMA LTD
LETROZOLE~TABLET;ORAL~LETROZOLE~ROXANE~2.5MG~A~090838~001~AB~Jun 3, 2011~No~RX~R
LETROZOLE~TABLET;ORAL~LETROZOLE~SUN PHARM INDS LTD~2.5MG~A~091466~001~AB~Jun 3,
2011~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
LETROZOLE~TABLET;ORAL~LETROZOLE~SYNTHON PHARMS~2.5MG~A~090196~001~~Jun 3, 2011~N
o~DISCN~SYNTHON PHARMACEUTICALS INC
LETROZOLE~TABLET;ORAL~LETROZOLE~TEVA PHARMS~2.5MG~A~090289~001~AB~Jun 3, 2011~No
LETROZOLE~TABLET;ORAL~LETROZOLE~VINTAGE PHARMS LLC~2.5MG~A~090789~001~AB~Jun 3,
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~BARR~EQ 5MG BASE~A~071198~001~
AB~Sep 24, 1987~No~RX~BARR PHARMACEUTICALS
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~BARR~EQ 25MG BASE~A~071199~001
~AB~Sep 24, 1987~No~RX~BARR PHARMACEUTICALS
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~COREPHARMA~EQ 5MG BASE~A~07454

4~001~~Aug 28, 1997~No~DISCN~COREPHARMA LLC
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~COREPHARMA~EQ 25MG BASE~A~0745
44~002~~Aug 28, 1997~No~DISCN~COREPHARMA LLC
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~PAR PHARM~EQ 5MG BASE~A~071600
~001~~Oct 14, 1987~No~DISCN~PAR PHARMACEUTICAL INC
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~PAR PHARM~EQ 25MG BASE~A~07159
8~001~~Oct 14, 1987~No~DISCN~PAR PHARMACEUTICAL INC
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~PHARMACHEMIE~EQ 5MG BASE~A~073
099~001~~Mar 28, 1997~No~DISCN~PHARMACHEMIE BV
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~PHARMACHEMIE~EQ 25MG BASE~A~07
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~ROXANE~EQ 5MG BASE~A~072733~00
01~~Feb 22, 1993~No~RX~ROXANE LABORATORIES INC
01~AB~Feb 22, 1993~Yes~RX~ROXANE LABORATORIES INC
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~SANDOZ~EQ 15MG BASE~A~075327~0
01~~Mar 24, 1999~No~DISCN~SANDOZ INC
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~XANODYNE PHARM~EQ 5MG BASE~N~0
18459~001~~Jan 30, 1986~No~DISCN~XANODYNE PHARMACEUTICS INC
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~XANODYNE PHARM~EQ 10MG BASE~A~
071962~001~~Nov 19, 1987~No~DISCN~XANODYNE PHARMACEUTICS INC
LEUCOVORIN CALCIUM~TABLET;ORAL~LEUCOVORIN CALCIUM~XANODYNE PHARM~EQ 15MG BASE~A~
071104~001~~Mar 4, 1987~No~DISCN~XANODYNE PHARMACEUTICS INC
CHLORAMBUCIL~TABLET;ORAL~LEUKERAN~ASPEN GLOBAL INC~2MG~N~010669~002~~Approved Pr
ior to Jan 1, 1982~Yes~RX~ASPEN GLOBAL INC
LEVOFLOXACIN~TABLET;ORAL~LEVAQUIN~JANSSEN PHARMS~250MG~N~020634~001~AB~Dec 20, 1
LEVOFLOXACIN~TABLET;ORAL~LEVAQUIN~JANSSEN PHARMS~500MG~N~020634~002~AB~Dec 20, 1
LEVOFLOXACIN~TABLET;ORAL~LEVAQUIN~JANSSEN PHARMS~750MG~N~020634~003~AB~Sep 8, 20
PENBUTOLOL SULFATE~TABLET;ORAL~LEVATOL~AUXILIUM PHARMS LLC~10MG **Federal Regist
ficacy reasons**~N~018976~001~~Dec 30, 1987~No~DISCN~AUXILIUM PHARMACEUTICALS LL
C
PENBUTOLOL SULFATE~TABLET;ORAL~LEVATOL~AUXILIUM PHARMS LLC~20MG **Federal Regist
ficacy reasons**~N~018976~004~~Jan 5, 1989~No~DISCN~AUXILIUM PHARMACEUTICALS LLC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ACCORD HLTHCARE~1GM~A~090843~004~AB~Feb
14, 2011~No~RX~ACCORD HEALTHCARE INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ACCORD HLTHCARE~250MG~A~090843~001~AB~Fe
b 14, 2011~No~RX~ACCORD HEALTHCARE INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ACTAVIS LABS FL INC~250MG~A~077408~001~~
Mar 2, 2009~No~DISCN~ACTAVIS LABORATORIES FL INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~AJANTA PHARMA~1GM~A~201293~004~AB~Jun 14
, 2011~No~RX~AJANTA PHARMA LTD
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~AJANTA PHARMA~250MG~A~201293~001~AB~Jun
14, 2011~No~RX~AJANTA PHARMA LTD

LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~APOTEX INC~1GM~A~078869~004~AB~Mar 13, 2
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~APOTEX INC~250MG~A~078869~001~AB~Mar 13,
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~AUROBINDO PHARMA~1GM~A~078993~004~AB~Jan
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~AUROBINDO PHARMA~250MG~A~078993~001~AB~J
an 15, 2009~No~RX~AUROBINDO PHARMA LTD
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~BRECKENRIDGE PHARM~1GM~A~090511~004~AB~A
ug 18, 2011~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~BRECKENRIDGE PHARM~250MG~A~090511~001~AB
~Aug 18, 2011~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~DR REDDYS LABS LTD~1GM~A~078904~001~AB~J
an 15, 2009~No~RX~DR REDDYS LABORATORIES LTD
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~DR REDDYS LABS LTD~250MG~A~076920~001~AB
~Jan 15, 2009~No~RX~DR REDDYS LABORATORIES LTD
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~HETERO LABS LTD III~1GM~A~090515~004~AB~
Oct 8, 2010~No~RX~HETERO LABS LTD UNIT III
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~HETERO LABS LTD III~250MG~A~090515~001~A
B~Oct 8, 2010~No~RX~HETERO LABS LTD UNIT III
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~INVAGEN PHARMS~250MG~A~078234~001~AB~Jan
15, 2009~No~RX~INVAGEN PHARMACEUTICALS INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~LOTUS PHARM CO LTD~500MG~A~090906~001~AB
~Nov 5, 2010~No~RX~LOTUS PHARMACEUTICAL CO LTD
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~LUPIN~1GM~A~090025~001~AB~Jan 15, 2009~N
o~RX~LUPIN LTD
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~LUPIN~250MG~A~078154~001~AB~Jan 15, 2009
~No~RX~LUPIN LTD
~No~RX~LUPIN LTD
~No~RX~LUPIN LTD
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~METHAPHARM~1GM~A~090767~004~AB~Jul 28, 2
010~No~RX~METHAPHARM INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~METHAPHARM~250MG~A~090767~001~AB~Jul 28,
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~MYLAN~1GM~A~078731~004~~Feb 10, 2009~No~
DISCN~MYLAN PHARMACEUTICALS INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~MYLAN~1GM~A~090261~001~AB~Dec 8, 2009~No
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~MYLAN~250MG~A~076919~001~AB~Nov 4, 2008~
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~MYLAN~250MG~A~078731~001~~Feb 10, 2009~N
o~DISCN~MYLAN PHARMACEUTICALS INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ORCHID HLTHCARE~1GM~A~090484~001~AB~Aug
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ORCHID HLTHCARE~250MG~A~078526~001~AB~Ja
n 15, 2009~No~RX~ORCHID HEALTHCARE
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~PRINSTON INC~1GM~A~078106~004~AB~Feb 10,
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~PRINSTON INC~250MG~A~078106~001~AB~Feb 1
0, 2009~No~RX~PRINSTON PHARMACEUTICAL INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ROXANE~1GM~A~078042~004~AB~Jan 15, 2009~
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ROXANE~250MG~A~078042~001~AB~Jan 15, 200
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~SANDOZ~1GM~A~077324~004~~Jan 15, 2009~No
~DISCN~SANDOZ INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~SANDOZ~250MG~A~077324~001~~Jan 15, 2009~
No~DISCN~SANDOZ INC
No~DISCN~SANDOZ INC
No~DISCN~SANDOZ INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~TARO~1GM~A~078960~001~AB~Feb 1, 2010~No~
RX~TARO PHARMACEUTICAL INDUSTRIES LTD
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~TARO~250MG~A~078960~004~AB~Feb 1, 2010~N

LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~TEVA PHARMS~1GM~A~078101~004~AB~Jan 15,
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~TEVA PHARMS~250MG~A~078101~001~AB~Jan 15
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~TORRENT PHARMS~1GM~A~078858~004~AB~Jan 1
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~TORRENT PHARMS~250MG~A~078858~001~AB~Jan
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~VINTAGE PHARMS~1GM~A~091491~004~AB~Dec 1
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~VINTAGE PHARMS~250MG~A~077319~001~AB~Mar
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~VINTAGE PHARMS~250MG~A~091491~001~AB~Dec
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~WATSON LABS INC~1GM~A~078797~001~~Jan 15
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~WATSON LABS INC~250MG~A~078797~002~~Jan
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~WOCKHARDT~1GM~A~079042~004~AB~Jan 15, 20
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~WOCKHARDT~250MG~A~079042~001~AB~Jan 15,
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ZYDUS PHARMS USA INC~1GM~A~078918~002~AB
~Apr 29, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
LEVETIRACETAM~TABLET;ORAL~LEVETIRACETAM~ZYDUS PHARMS USA INC~250MG~A~078918~001~
AB~Apr 29, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
VARDENAFIL HYDROCHLORIDE~TABLET;ORAL~LEVITRA~BAYER HLTHCARE~2.5MG~N~021400~003~A
B~Aug 19, 2003~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
VARDENAFIL HYDROCHLORIDE~TABLET;ORAL~LEVITRA~BAYER HLTHCARE~5MG~N~021400~001~AB~
Aug 19, 2003~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
VARDENAFIL HYDROCHLORIDE~TABLET;ORAL~LEVITRA~BAYER HLTHCARE~10MG~N~021400~002~AB
~Aug 19, 2003~No~RX~BAYER HEALTHCARE PHARMACEUTICALS INC

VARDENAFIL HYDROCHLORIDE~TABLET;ORAL~LEVITRA~BAYER HLTHCARE~20MG~N~021400~004~AB
~Aug 19, 2003~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
LEVORPHANOL TARTRATE~TABLET;ORAL~LEVO-DROMORAN~VALEANT PHARM INTL~2MG~N~008720~0
01~~Dec 19, 1991~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVO-T~ALARA PHARM~0.025MG **See current Annual
Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~N~021342~0
01~AB1,AB2,AB3~Mar 1, 2002~No~RX~ALARA PHARMACEUTICAL CORPORATION
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVO-T~ALARA PHARM~0.1MG **See current Annual E
dition, 1.8 Description of Special Situations, Levothyroxine Sodium~N~021342~005
~AB1,AB2,AB3~Mar 1, 2002~No~RX~ALARA PHARMACEUTICAL CORPORATION
12~AB1,AB2,AB3~Dec 8, 2003~No~RX~ALARA PHARMACEUTICAL CORPORATION
~AB1,AB2,AB3~Mar 1, 2002~No~RX~ALARA PHARMACEUTICAL CORPORATION
~AB1,AB2,AB3~Mar 1, 2002~Yes~RX~ALARA PHARMACEUTICAL CORPORATION
LEVOCARNITINE~TABLET;ORAL~LEVOCARNITINE~COREPHARMA~330MG~A~076858~001~AB~Sep 20,
2004~No~RX~COREPHARMA LLC
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~APOTEX
INC~5MG~A~203027~001~AB~Feb 13, 2015~No~RX~APOTEX INC
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~DR RED
DYS LABS LTD~5MG~A~090392~001~AB~Feb 24, 2011~No~RX~DR REDDYS LABORATORIES LIMIT
ED
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~GLENMA
RK GENERICS~5MG~A~090385~001~AB~Feb 24, 2011~No~RX~GLENMARK GENERICS LIMITED
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~HETERO
LABS LTD III~5MG~A~091264~001~AB~Jun 29, 2012~No~RX~HETERO LABS LTD UNIT III
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~MICRO
LABS LTD INDIA~5MG~A~202046~001~AB~Sep 17, 2013~No~RX~MICRO LABS LTD INDIA
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~SANDOZ
~5MG~A~090486~001~~Mar 26, 2013~No~DISCN~SANDOZ INC
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~SCIEGE
N PHARMS INC~5MG~A~203646~001~AB~Sep 9, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~SUN PH
ARMA GLOBAL~5MG~A~090362~001~AB~Jan 31, 2013~No~RX~SUN PHARMA GLOBAL FZE
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~SYNTHO

N PHARMS~5MG~A~090229~001~AB~Nov 26, 2010~No~RX~SYNTHON PHARMACEUTICALS INC
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~LEVOCETIRIZINE DIHYDROCHLORIDE~TEVA P
HARMS~5MG~A~090199~001~AB~Aug 22, 2011~No~RX~TEVA PHARMACEUTICALS USA
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~APOTEX INC~250MG~A~090787~001~AB~Sep 29, 2
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~AUROBINDO PHARMA LTD~250MG~A~201043~001~AB
~Jun 20, 2011~No~RX~AUROBINDO PHARMA LIMITED
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~CIPLA LTD~250MG~A~076890~001~AB~Mar 30, 20
12~No~RX~CIPLA LTD
12~No~RX~CIPLA LTD
12~No~RX~CIPLA LTD
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~DR REDDYS LABS INC~250MG~A~076710~001~AB~J
un 20, 2011~No~RX~DR REDDYS LABORATORIES INC
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~GLENMARK GENERICS~250MG~A~200250~001~AB~Ju
n 20, 2011~No~RX~GLENMARK GENERICS LTD
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~HETERO LABS LTD V~250MG~A~202801~001~AB~Ja
n 8, 2015~No~RX~HETERO LABS LTD UNIT V
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~LUPIN~250MG~A~078424~001~AB~Jun 20, 2011~N
o~RX~LUPIN LTD
o~RX~LUPIN LTD
o~RX~LUPIN LTD
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~MACLEODS PHARMS LTD~250MG~A~200839~001~AB~
Mar 22, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~MYLAN~250MG~A~076276~001~AB~Jun 20, 2011~N
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~ORCHID HLTHCARE~250MG~A~202200~001~AB~Jan
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~SANDOZ~250MG~A~077438~001~AB~Jun 20, 2011~
No~RX~SANDOZ INC
No~RX~SANDOZ INC
No~RX~SANDOZ INC
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~TEVA~250MG~A~076361~001~AB~Jun 20, 2011~No
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~TORRENT PHARMS~250MG~A~090722~001~AB~Jun 2
0, 2011~No~RX~TORRENT PHARMACEUTICALS LIMITED
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~WATSON LABS INC~250MG~A~201484~001~~Nov 22
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~WOCKHARDT~250MG~A~090367~001~AB~Jun 20, 20
LEVOFLOXACIN~TABLET;ORAL~LEVOFLOXACIN~ZYDUS PHARMS USA INC~250MG~A~077652~001~AB
~Sep 7, 2012~No~RX~ZYDUS PHARMACEUTICALS USA INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOLET~VINTAGE~0.025MG~N~021137~001~~Jun 6, 20
~No~DISCN~VINTAGE PHARMACEUTICALS LLC

LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~FAMY CARE LTD~1.5MG~A~202739~001~~Oct
31, 2014~No~OTC~FAMY CARE LTD
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~LUPIN LTD~0.75MG~A~091328~001~~Jan 23,
2013~No~DISCN~LUPIN LTD
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~NOVEL LABS INC~1.5MG~A~202508~001~AB~F
eb 22, 2013~No~RX~NOVEL LABORATORIES INC
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~NOVEL LABS INC~1.5MG~A~202508~001~~Feb
22, 2013~No~OTC~NOVEL LABORATORIES INC
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~PERRIGO R AND D~0.75MG~A~090740~001~~D
ec 30, 2010~No~OTC~PERRIGO R AND D CO
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~PERRIGO R AND D~0.75MG~A~090740~001~AB
~Dec 30, 2010~No~RX~PERRIGO R AND D CO
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~PERRIGO R AND D~1.5MG~A~202334~001~~Au
g 20, 2014~No~OTC~PERRIGO R AND D CO
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~WATSON LABS~0.75MG~A~078665~001~~Aug 2
8, 2009~Yes~OTC~WATSON LABORATORIES INC
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~WATSON LABS~0.75MG~A~078665~001~AB~Aug
28, 2009~Yes~RX~WATSON LABORATORIES INC
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~WATSON LABS~0.75MG~A~078666~001~~Jun 2
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~WATSON LABS INC~1.5MG~A~200670~001~~Ju
l 12, 2012~No~OTC~WATSON LABORATORIES INC
LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL~WATSON LABS INC~1.5MG~A~200670~001~AB~
Jul 12, 2012~No~RX~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~LEVONORGESTREL AND ETHINYL ESTRADI
OL~LUPIN LTD~0.02MG,0.01MG;0.1MG,N/A~A~091674~001~AB~Oct 26, 2011~No~RX~LUPIN LI
MITED
OL~LUPIN LTD~0.03MG;0.15MG~A~091440~001~AB~Oct 23, 2012~No~RX~LUPIN LTD
OL~WATSON LABS~0.02MG;0.09MG~A~079218~001~~Jun 6, 2011~Yes~RX~WATSON LABORATORIE
S INC
OL~WATSON LABS~0.02MG,0.01MG;0.1MG,N/A~A~200407~001~AB~Oct 25, 2011~No~RX~WATSON
LABORATORIES INC
OL AND ETHINYL ESTRADIOL~WATSON LABS~0.03MG,0.01MG;0.15MG,N/A~A~078834~001~AB~Ma
y 31, 2011~No~RX~WATSON LABORATORIES INC
LEVORPHANOL TARTRATE~TABLET;ORAL~LEVORPHANOL TARTRATE~ROXANE~2MG~A~074278~001~~M
ar 31, 2000~Yes~RX~ROXANE LABORATORIES INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOTHROID~LLOYD~0.025MG **See current Annual E
~AB4~Oct 24, 2002~No~RX~LLOYD INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOTHROID~LLOYD~0.05MG **See current Annual Ed
ition, 1.8 Description of Special Situations, Levothyroxine Sodium~N~021116~002~
AB4~Oct 24, 2002~No~RX~LLOYD INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOTHROID~LLOYD~0.1MG **See current Annual Edi
tion, 1.8 Description of Special Situations, Levothyroxine Sodium~N~021116~004~A
B4~Oct 24, 2002~No~RX~LLOYD INC

~AB4~Dec 7, 2004~No~RX~LLOYD INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOTHROID~LLOYD~0.15MG **See current Annual Ed
AB4~Oct 24, 2002~No~RX~LLOYD INC
B4~Oct 24, 2002~No~RX~LLOYD INC
B4~Oct 24, 2002~Yes~RX~LLOYD INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOTHYROXINE SODIUM~MERCK KGAA~0.025MG~A~07675
2~001~~Jun 16, 2005~No~DISCN~MERCK KGAA
~002~~Jun 16, 2005~No~DISCN~MERCK KGAA
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOTHYROXINE SODIUM~MERCK KGAA~0.1MG~A~076752~
005~~Jun 16, 2005~No~DISCN~MERCK KGAA
~008~~Jun 16, 2005~No~DISCN~MERCK KGAA
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOTHYROXINE SODIUM~MYLAN~0.025MG **See curren
t Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~A~
076187~001~AB1,AB2,AB3,AB4~Jun 5, 2002~No~RX~MYLAN PHARMACEUTICALS INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOTHYROXINE SODIUM~MYLAN~0.05MG **See current
Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~A~0

076187~012~AB1,AB2,AB3,AB4~Dec 13, 2006~No~RX~MYLAN PHARMACEUTICALS INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOXYL~KING PHARMS R AND D~0.025MG **See curre
nt Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~N
~021301~001~AB1,AB3~May 25, 2001~No~RX~KING PHARMACEUTICALS RESEARCH AND DEVELOP
MENT INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOXYL~KING PHARMS R AND D~0.05MG **See curren
t Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~N~
021301~002~AB1,AB3~May 25, 2001~No~RX~KING PHARMACEUTICALS RESEARCH AND DEVELOPM
ENT INC
MENT INC
MENT INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOXYL~KING PHARMS R AND D~0.1MG **See current
Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~N~0
21301~005~AB1,AB3~May 25, 2001~No~RX~KING PHARMACEUTICALS RESEARCH AND DEVELOPME
NT INC
MENT INC
MENT INC
MENT INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOXYL~KING PHARMS R AND D~0.15MG **See curren
t Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~N~
021301~009~AB1,AB3~May 25, 2001~No~RX~KING PHARMACEUTICALS RESEARCH AND DEVELOPM
ENT INC
MENT INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOXYL~KING PHARMS R AND D~0.2MG **See current
Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~N~0
21301~011~AB1,AB3~May 25, 2001~Yes~RX~KING PHARMACEUTICALS RESEARCH AND DEVELOPM

ENT INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~LEVOXYL~KING PHARMS R AND D~0.3MG~N~021301~012~
~May 25, 2001~No~DISCN~KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC
ESCITALOPRAM OXALATE~TABLET;ORAL~LEXAPRO~FOREST LABS~EQ 5MG BASE~N~021323~001~AB
~Aug 14, 2002~No~RX~FOREST LABORATORIES INC
ESCITALOPRAM OXALATE~TABLET;ORAL~LEXAPRO~FOREST LABS~EQ 10MG BASE~N~021323~002~A
B~Aug 14, 2002~No~RX~FOREST LABORATORIES INC
ESCITALOPRAM OXALATE~TABLET;ORAL~LEXAPRO~FOREST LABS~EQ 20MG BASE~N~021323~003~A
B~Aug 14, 2002~Yes~RX~FOREST LABORATORIES INC
FOSAMPRENAVIR CALCIUM~TABLET;ORAL~LEXIVA~VIIV HLTHCARE~EQ 700MG BASE~N~021548~00
1~~Oct 20, 2003~Yes~RX~VIIV HEALTHCARE CO
CHLORDIAZEPOXIDE~TABLET;ORAL~LIBRITABS~VALEANT PHARM INTL~5MG~A~085482~001~~Appr
CHLORDIAZEPOXIDE~TABLET;ORAL~LIBRITABS~VALEANT PHARM INTL~10MG~A~085481~001~~App
roved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
CHLORDIAZEPOXIDE~TABLET;ORAL~LIBRITABS~VALEANT PHARM INTL~25MG~A~085488~001~~App
roved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE~TABLET;ORAL~LIMBITROL~VALEANT PHAR
M INTL~EQ 12.5MG BASE;5MG~N~016949~001~~Approved Prior to Jan 1, 1982~No~DISCN~V
ALEANT PHARMACEUTICALS INTERNATIONAL
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE~TABLET;ORAL~LIMBITROL DS~VALEANT P
HARM INTL~EQ 25MG BASE;10MG~N~016949~002~~Approved Prior to Jan 1, 1982~No~DISCN
~VALEANT PHARMACEUTICALS INTERNATIONAL
BACLOFEN~TABLET;ORAL~LIORESAL~NOVARTIS~10MG~N~017851~001~~Approved Prior to Jan
BACLOFEN~TABLET;ORAL~LIORESAL~NOVARTIS~20MG~N~017851~003~~Jan 20, 1982~No~DISCN~
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~COASTAL PHARMS~EQ 0.005MG BA
SE~A~090097~001~AB~Mar 20, 2009~No~RX~COASTAL PHARMACEUTICALS
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~COASTAL PHARMS~EQ 0.025MG BA
SE~A~090097~002~AB~Mar 20, 2009~No~RX~COASTAL PHARMACEUTICALS
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~COASTAL PHARMS~EQ 0.05MG BAS
E~A~090097~003~AB~Mar 20, 2009~No~RX~COASTAL PHARMACEUTICALS
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~MYLAN~EQ 0.005MG BASE~A~0903
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~SIGMAPHARM LABS LLC~EQ 0.005
MG BASE~A~200295~001~AB~Nov 29, 2012~No~RX~SIGMAPHARM LABORATORIES LLC
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~SIGMAPHARM LABS LLC~EQ 0.025
MG BASE~A~200295~002~AB~Nov 29, 2012~No~RX~SIGMAPHARM LABORATORIES LLC
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~SIGMAPHARM LABS LLC~EQ 0.05M
G BASE~A~200295~003~AB~Nov 29, 2012~No~RX~SIGMAPHARM LABORATORIES LLC
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~WATSON LABS~EQ 0.025MG BASE~
A~085755~001~~Jan 25, 1982~No~DISCN~WATSON LABORATORIES INC
LIOTHYRONINE SODIUM~TABLET;ORAL~LIOTHYRONINE SODIUM~WATSON LABS~EQ 0.05MG BASE~A
~085753~001~~Feb 3, 1982~No~DISCN~WATSON LABORATORIES INC
ATORVASTATIN CALCIUM~TABLET;ORAL~LIPITOR~PFIZER~EQ 10MG BASE~N~020702~001~AB~Dec
ATORVASTATIN CALCIUM~TABLET;ORAL~LIPITOR~PFIZER~EQ 80MG BASE~N~020702~004~AB~Apr
ATORVASTATIN CALCIUM; EZETIMIBE~TABLET;ORAL~LIPTRUZET~MERCK SHARP DOHME~EQ 10MG
BASE;10MG~N~200153~001~~May 3, 2013~No~RX~MERCK SHARP AND DOHME CORP

BASE;10MG~N~200153~004~~May 3, 2013~Yes~RX~MERCK SHARP AND DOHME CORP
PHENPROCOUMON~TABLET;ORAL~LIQUAMAR~ORGANON USA INC~3MG~N~011228~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~ORGANON USA INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~ACCORD HLTHCARE~2.5MG~A~202554~001~AB~Jul 30,
LISINOPRIL~TABLET;ORAL~LISINOPRIL~ACCORD HLTHCARE~5MG~A~202554~002~AB~Jul 30, 20
LISINOPRIL~TABLET;ORAL~LISINOPRIL~APOTEX INC~2.5MG~A~076102~001~AB~Sep 30, 2002~
LISINOPRIL~TABLET;ORAL~LISINOPRIL~APOTEX INC~5MG~A~076102~002~AB~Sep 30, 2002~No
LISINOPRIL~TABLET;ORAL~LISINOPRIL~APOTEX INC~10MG~A~076102~003~AB~Sep 30, 2002~N
LISINOPRIL~TABLET;ORAL~LISINOPRIL~AUROBINDO~2.5MG~A~077622~001~AB~Feb 22, 2006~N
o~RX~AUROBINDO PHARMA LTD
LISINOPRIL~TABLET;ORAL~LISINOPRIL~AUROBINDO~5MG~A~077622~002~AB~Feb 22, 2006~No~
RX~AUROBINDO PHARMA LTD
LISINOPRIL~TABLET;ORAL~LISINOPRIL~AUROBINDO~10MG~A~077622~003~AB~Feb 22, 2006~No
~RX~AUROBINDO PHARMA LTD
LISINOPRIL~TABLET;ORAL~LISINOPRIL~HIKMA INTL PHARMS~2.5MG~A~076063~001~AB~Jul 1,
LISINOPRIL~TABLET;ORAL~LISINOPRIL~HIKMA INTL PHARMS~5MG~A~076063~002~AB~Jul 1, 2
LISINOPRIL~TABLET;ORAL~LISINOPRIL~HIKMA INTL PHARMS~10MG~A~076063~003~AB~Jul 1,
LISINOPRIL~TABLET;ORAL~LISINOPRIL~HIKMA INTL PHARMS~30MG~A~076063~006~AB~Jun 27,
LISINOPRIL~TABLET;ORAL~LISINOPRIL~INVAGEN PHARMS~2.5MG~A~203508~001~AB~Oct 29, 2
LISINOPRIL~TABLET;ORAL~LISINOPRIL~INVAGEN PHARMS~5MG~A~203508~002~AB~Oct 29, 201

LISINOPRIL~TABLET;ORAL~LISINOPRIL~IVAX SUB TEVA PHARMS~2.5MG~A~075752~001~AB~Jul
LISINOPRIL~TABLET;ORAL~LISINOPRIL~IVAX SUB TEVA PHARMS~5MG~A~075752~002~AB~Jul 1
LISINOPRIL~TABLET;ORAL~LISINOPRIL~IVAX SUB TEVA PHARMS~10MG~A~075752~003~AB~Jul
LISINOPRIL~TABLET;ORAL~LISINOPRIL~LUPIN~2.5MG~A~077321~001~AB~Sep 9, 2005~No~RX~
LUPIN LTD
LISINOPRIL~TABLET;ORAL~LISINOPRIL~LUPIN~5MG~A~077321~002~AB~Sep 9, 2005~No~RX~LU
PIN LTD
LISINOPRIL~TABLET;ORAL~LISINOPRIL~LUPIN~10MG~A~077321~003~AB~Sep 9, 2005~No~RX~L
UPIN LTD
UPIN LTD
UPIN LTD
UPIN LTD
LISINOPRIL~TABLET;ORAL~LISINOPRIL~MYLAN~2.5MG~A~076071~001~AB~Jul 1, 2002~No~RX~
LISINOPRIL~TABLET;ORAL~LISINOPRIL~MYLAN~5MG~A~076071~002~AB~Jul 1, 2002~No~RX~MY
LISINOPRIL~TABLET;ORAL~LISINOPRIL~MYLAN~10MG~A~076071~003~AB~Jul 1, 2002~No~RX~M
LISINOPRIL~TABLET;ORAL~LISINOPRIL~PRINSTON INC~2.5MG~A~076180~001~AB~Jul 1, 2002
~No~RX~PRINSTON PHARMACEUTICAL INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~PRINSTON INC~5MG~A~076180~002~AB~Jul 1, 2002~N
o~RX~PRINSTON PHARMACEUTICAL INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~PRINSTON INC~10MG~A~076180~003~AB~Jul 1, 2002~
No~RX~PRINSTON PHARMACEUTICAL INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~RANBAXY~2.5MG~A~075944~001~AB~Jul 1, 2002~No~R
X~RANBAXY PHARMACEUTICALS INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~RANBAXY~5MG~A~075944~002~AB~Jul 1, 2002~No~RX~
RANBAXY PHARMACEUTICALS INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~RANBAXY~10MG~A~075944~003~AB~Jul 1, 2002~No~RX
LISINOPRIL~TABLET;ORAL~LISINOPRIL~RANBAXY~30MG~A~075944~006~AB~Feb 11, 2003~No~R
X~RANBAXY PHARMACEUTICALS INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~SANDOZ~2.5MG~A~075903~001~~Jul 1, 2002~No~DISC
N~SANDOZ INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~SANDOZ~2.5MG~A~075994~001~AB~Jul 1, 2002~No~RX
~SANDOZ INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~SANDOZ~2.5MG~A~075999~001~~Jul 1, 2002~No~DISC
N~SANDOZ INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~SANDOZ~5MG~A~075903~002~~Jul 1, 2002~No~DISCN~
SANDOZ INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~SANDOZ~5MG~A~075994~002~AB~Jul 1, 2002~No~RX~S
ANDOZ INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~SANDOZ~5MG~A~075999~002~~Jul 1, 2002~No~DISCN~
SANDOZ INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~SANDOZ~10MG~A~075903~003~~Jul 1, 2002~No~DISCN
~SANDOZ INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~SANDOZ~10MG~A~075994~003~AB~Jul 1, 2002~No~RX~
SANDOZ INC
~SANDOZ INC
~SANDOZ INC
SANDOZ INC
~SANDOZ INC
~SANDOZ INC
SANDOZ INC
~SANDOZ INC
~SANDOZ INC
SANDOZ INC
~SANDOZ INC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~TEVA~2.5MG~A~075783~001~~Jul 1, 2002~No~DISCN~
LISINOPRIL~TABLET;ORAL~LISINOPRIL~TEVA~5MG~A~075783~002~~Jul 1, 2002~No~DISCN~TE
LISINOPRIL~TABLET;ORAL~LISINOPRIL~TEVA~10MG~A~075783~003~~Jul 1, 2002~No~DISCN~T
LISINOPRIL~TABLET;ORAL~LISINOPRIL~VINTAGE~2.5MG~A~075743~001~AB~Jul 1, 2002~No~R
X~VINTAGE PHARMACEUTICALS LLC
LISINOPRIL~TABLET;ORAL~LISINOPRIL~VINTAGE~5MG~A~075743~002~AB~Jul 1, 2002~No~RX~
LISINOPRIL~TABLET;ORAL~LISINOPRIL~VINTAGE~10MG~A~075743~003~AB~Jul 1, 2002~No~RX
LISINOPRIL~TABLET;ORAL~LISINOPRIL~WATSON LABS~2.5MG~A~076059~001~AB~Jul 1, 2002~
LISINOPRIL~TABLET;ORAL~LISINOPRIL~WATSON LABS~5MG~A~076059~002~AB~Jul 1, 2002~No
LISINOPRIL~TABLET;ORAL~LISINOPRIL~WATSON LABS~10MG~A~076059~003~AB~Jul 1, 2002~N
LISINOPRIL~TABLET;ORAL~LISINOPRIL~WOCKHARDT~2.5MG~A~078402~001~AB~Apr 19, 2007~N
o~RX~WOCKHARDT LTD
LISINOPRIL~TABLET;ORAL~LISINOPRIL~WOCKHARDT~5MG~A~078402~002~AB~Apr 19, 2007~No~
RX~WOCKHARDT LTD
LISINOPRIL~TABLET;ORAL~LISINOPRIL~WOCKHARDT~10MG~A~078402~003~AB~Apr 19, 2007~No
~RX~WOCKHARDT LTD
~RX~WOCKHARDT LTD
~RX~WOCKHARDT LTD
~RX~WOCKHARDT LTD
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~A
POTEX INC~12.5MG;10MG~A~076674~001~AB~Oct 5, 2004~No~RX~APOTEX INC ETOBICOKE SIT
E
POTEX INC~12.5MG;20MG~A~076674~002~AB~Oct 5, 2004~No~RX~APOTEX INC ETOBICOKE SIT
E
POTEX INC~25MG;20MG~A~076674~003~AB~Oct 5, 2004~No~RX~APOTEX INC ETOBICOKE SITE
UROBINDO~12.5MG;10MG~A~077606~001~AB~Mar 14, 2006~No~RX~AUROBINDO PHARMA LTD
UROBINDO~12.5MG;20MG~A~077606~002~AB~Mar 14, 2006~No~RX~AUROBINDO PHARMA LTD
UROBINDO~25MG;20MG~A~077606~003~AB~Mar 14, 2006~No~RX~AUROBINDO PHARMA LTD
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~H
IKMA INTL PHARMS~12.5MG;10MG~A~076265~001~AB~Jul 8, 2002~No~RX~HIKMA INTERNATION
AL PHARMACEUTICALS LLC
IKMA INTL PHARMS~12.5MG;20MG~A~076265~002~AB~Jul 8, 2002~No~RX~HIKMA INTERNATION
AL PHARMACEUTICALS LLC
IKMA INTL PHARMS~25MG;20MG~A~076265~003~AB~Jul 8, 2002~No~RX~HIKMA INTERNATIONAL
PHARMACEUTICALS LLC
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~I
VAX SUB TEVA PHARMS~12.5MG;10MG~A~075776~001~AB~Jul 1, 2002~No~RX~IVAX PHARMACEU
VAX SUB TEVA PHARMS~12.5MG;20MG~A~075776~002~AB~Jul 1, 2002~No~RX~IVAX PHARMACEU

VAX SUB TEVA PHARMS~25MG;20MG~A~075776~003~AB~Jul 1, 2002~No~RX~IVAX PHARMACEUTI
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~L
UPIN~12.5MG;10MG~A~077912~001~AB~Sep 27, 2006~No~RX~LUPIN LTD
UPIN~12.5MG;20MG~A~077912~002~AB~Sep 27, 2006~No~RX~LUPIN LTD
UPIN~25MG;20MG~A~077912~003~AB~Sep 27, 2006~No~RX~LUPIN LTD
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~M
YLAN~12.5MG;10MG~A~076113~001~AB~Jul 1, 2002~No~RX~MYLAN PHARMACEUTICALS INC
YLAN~12.5MG;20MG~A~076113~002~AB~Jul 1, 2002~No~RX~MYLAN PHARMACEUTICALS INC
YLAN~25MG;20MG~A~076113~003~AB~Jul 1, 2002~No~RX~MYLAN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~P
RINSTON INC~12.5MG;10MG~A~076230~001~AB~Jul 1, 2002~No~RX~PRINSTON PHARMACEUTICA
L INC
RINSTON INC~12.5MG;20MG~A~076230~002~AB~Jul 1, 2002~No~RX~PRINSTON PHARMACEUTICA
L INC
RINSTON INC~25MG;20MG~A~076230~003~AB~Jul 1, 2002~No~RX~PRINSTON PHARMACEUTICAL
INC
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~R
ANBAXY~12.5MG;10MG~A~076007~001~AB~Jul 1, 2002~No~RX~RANBAXY PHARMACEUTICALS INC
ANBAXY~12.5MG;20MG~A~076007~002~AB~Jul 1, 2002~No~RX~RANBAXY PHARMACEUTICALS INC
ANBAXY~25MG;20MG~A~076007~003~AB~Jul 1, 2002~No~RX~RANBAXY PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~S
ANDOZ~12.5MG;10MG~A~075926~001~~Jul 1, 2002~No~DISCN~SANDOZ INC
ANDOZ~12.5MG;10MG~A~076262~001~AB~Jul 1, 2002~No~RX~SANDOZ INC
ANDOZ~12.5MG;20MG~A~075926~002~~Jul 1, 2002~No~DISCN~SANDOZ INC
ANDOZ~12.5MG;20MG~A~076262~002~AB~Jul 1, 2002~No~RX~SANDOZ INC
ANDOZ~25MG;20MG~A~075926~003~~Jul 1, 2002~No~DISCN~SANDOZ INC
ANDOZ~25MG;20MG~A~076262~003~AB~Jul 1, 2002~No~RX~SANDOZ INC
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~T
EVA~12.5MG;10MG~A~075869~001~~Jul 1, 2002~No~DISCN~TEVA PHARMACEUTICALS USA INC
EVA~12.5MG;20MG~A~075869~002~~Jul 1, 2002~No~DISCN~TEVA PHARMACEUTICALS USA INC
EVA~25MG;20MG~A~075869~003~~Jul 1, 2002~No~DISCN~TEVA PHARMACEUTICALS USA INC
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~LISINOPRIL AND HYDROCHLOROTHIAZIDE~W
ATSON LABS~12.5MG;10MG~A~076194~003~AB~Jul 1, 2002~No~RX~WATSON LABS INC
ATSON LABS~12.5MG;20MG~A~076194~001~AB~Jul 1, 2002~No~RX~WATSON LABS INC
ATSON LABS~25MG;20MG~A~076194~002~AB~Jul 1, 2002~No~RX~WATSON LABS INC
LITHIUM CARBONATE~TABLET;ORAL~LITHANE~BAYER PHARMS~300MG~N~018833~001~~Jul 18, 1
LITHIUM CARBONATE~TABLET;ORAL~LITHIUM CARBONATE~HIKMA INTL PHARMS~300MG~A~078715
~001~~Dec 28, 2010~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
LITHIUM CARBONATE~TABLET;ORAL~LITHIUM CARBONATE~PFIZER~300MG~N~016834~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~PFIZER INC

LITHIUM CARBONATE~TABLET;ORAL~LITHIUM CARBONATE~ROXANE~300MG~N~018558~001~AB~Jan
29, 1982~Yes~RX~ROXANE LABORATORIES INC
LITHIUM CARBONATE~TABLET;ORAL~LITHIUM CARBONATE~SUN PHARM INDS INC~300MG~A~09102
7~001~AB~Jun 24, 2010~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
ACETOHYDROXAMIC ACID~TABLET;ORAL~LITHOSTAT~MISSION PHARMA~250MG~N~018749~001~~Ma
y 31, 1983~Yes~RX~MISSION PHARMACAL CO
LITHIUM CARBONATE~TABLET;ORAL~LITHOTABS~SOLVAY~300MG~N~016980~001~~Approved Prio
PITAVASTATIN CALCIUM~TABLET;ORAL~LIVALO~KOWA CO~EQ 1MG BASE~N~022363~001~~Aug 3,
2009~No~RX~KOWA CO LTD
2009~No~RX~KOWA CO LTD
2009~Yes~RX~KOWA CO LTD
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~LO LOESTRIN FE~WARNER CHILC
OTT LLC~0.01MG,0.01MG;1MG,N/A~N~022501~001~~Oct 21, 2010~Yes~RX~WARNER CHILCOTT
CO LLC
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~TABLET;ORAL~LO-TROL~VANGARD~0.025M
G;2.5MG~A~088009~001~~Mar 25, 1983~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY
MEDICAL CO
ETODOLAC~TABLET;ORAL~LODINE~WYETH PHARMS INC~400MG~N~018922~004~~Jul 29, 1993~No
~DISCN~WYETH PHARMACEUTICALS INC
ETODOLAC~TABLET;ORAL~LODINE~WYETH PHARMS INC~500MG~N~018922~005~~Jun 28, 1996~No
~DISCN~WYETH PHARMACEUTICALS INC
CARBIDOPA~TABLET;ORAL~LODOSYN~ATON~25MG~N~017830~001~AB~Approved Prior to Jan 1,
1982~Yes~RX~ATON PHARMA INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~LOESTRIN 24 FE~WARNER CHILC
OTT~0.02MG;1MG~N~021871~001~~Feb 17, 2006~No~DISCN~WARNER CHILCOTT INC
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~TABLET;ORAL~LOGEN~SUPERPHARM~0.025
MG;2.5MG~A~088962~001~~May 10, 1985~No~DISCN~SUPERPHARM CORP
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~TABLET;ORAL~LOMOTIL~GD SEARLE LLC~
0.025MG;2.5MG~N~012462~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~GD SEARLE LLC
MINOXIDIL~TABLET;ORAL~LONITEN~PHARMACIA AND UPJOHN~2.5MG~N~018154~001~~Approved
Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
MINOXIDIL~TABLET;ORAL~LONITEN~PHARMACIA AND UPJOHN~10MG~N~018154~003~~Approved P
rior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~TABLET;ORAL~LONOX~SANDOZ~0.025MG;2
.5MG~A~085311~002~AA~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
LOPERAMIDE HYDROCHLORIDE~TABLET;ORAL~LOPERAMIDE HYDROCHLORIDE~ABLE~2MG~A~073528~
001~~Nov 30, 1993~No~DISCN~ABLE LABORATORIES INC
LOPERAMIDE HYDROCHLORIDE~TABLET;ORAL~LOPERAMIDE HYDROCHLORIDE~CONTRACT PHARMACAL
~2MG~A~073254~001~~Jul 30, 1993~No~OTC~CONTRACT PHARMACAL CORP
LOPERAMIDE HYDROCHLORIDE~TABLET;ORAL~LOPERAMIDE HYDROCHLORIDE~LNK~2MG~A~076497~0
01~~Jun 10, 2003~No~OTC~LNK INTERNATIONAL INC
LOPERAMIDE HYDROCHLORIDE~TABLET;ORAL~LOPERAMIDE HYDROCHLORIDE~OHM LABS~2MG~A~074
091~001~~Dec 10, 1992~No~OTC~OHM LABORATORIES INC
LOPERAMIDE HYDROCHLORIDE~TABLET;ORAL~LOPERAMIDE HYDROCHLORIDE~PERRIGO~2MG~A~0741
94~001~~Oct 30, 1992~No~DISCN~L PERRIGO CO
LOPERAMIDE HYDROCHLORIDE~TABLET;ORAL~LOPERAMIDE HYDROCHLORIDE~PERRIGO~2MG~A~0752
32~001~~Jan 6, 2000~No~OTC~PERRIGO CO
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE~TABLET;ORAL~LOPERAMIDE HYDROCHLORIDE AND S
IMETHICONE~RANBAXY~2MG;125MG~A~077500~001~~Sep 6, 2006~No~OTC~RANBAXY PHARMACEUT
ICALS INC
GEMFIBROZIL~TABLET;ORAL~LOPID~PFIZER PHARMS~600MG~N~018422~003~AB~Nov 20, 1986~Y
es~RX~PFIZER PHARMACEUTICALS LTD
METOPROLOL TARTRATE~TABLET;ORAL~LOPRESSOR~US PHARMS HOLDINGS I~50MG~N~017963~001
~AB~Approved Prior to Jan 1, 1982~No~RX~US PHARMACEUTICALS HOLDINGS I LLC
METOPROLOL TARTRATE~TABLET;ORAL~LOPRESSOR~US PHARMS HOLDINGS I~100MG~N~017963~00
2~AB~Approved Prior to Jan 1, 1982~No~RX~US PHARMACEUTICALS HOLDINGS I LLC
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE~TABLET;ORAL~LOPRESSOR HCT~US PHARMS HOL

DINGS I~25MG;50MG~N~018303~001~AB~Dec 31, 1984~No~RX~US PHARMACEUTICALS HOLDINGS
I LLC
DINGS I~25MG;100MG~N~018303~002~AB~Dec 31, 1984~Yes~RX~US PHARMACEUTICALS HOLDIN
GS I LLC
DINGS I~50MG;100MG~N~018303~003~~Dec 31, 1984~No~DISCN~US PHARMACEUTICALS HOLDIN
GS I LLC
ALLOPURINOL~TABLET;ORAL~LOPURIN~ABBOTT~100MG~N~018297~001~~Approved Prior to Jan
ALLOPURINOL~TABLET;ORAL~LOPURIN~ABBOTT~300MG~N~018297~002~~Approved Prior to Jan
ALLOPURINOL~TABLET;ORAL~LOPURIN~DR REDDYS LA~100MG~A~071586~001~AB~Apr 2, 1987~N
o~RX~DR REDDYS LABORATORIES LOUISIANA LLC
ALLOPURINOL~TABLET;ORAL~LOPURIN~DR REDDYS LA~300MG~A~071587~001~AB~Apr 2, 1987~N
o~RX~DR REDDYS LABORATORIES LOUISIANA LLC
LORATADINE~TABLET;ORAL~LORATADINE~APOTEX INC~10MG~A~076471~001~~Feb 14, 2006~No~
OTC~APOTEX INC ETOBICOKE SITE
LORATADINE~TABLET;ORAL~LORATADINE~MYLAN~10MG~A~075790~001~~Nov 7, 2008~No~OTC~MY
LORATADINE~TABLET;ORAL~LORATADINE~MYLAN~10MG~A~076154~001~~Aug 20, 2003~No~OTC~M
LORATADINE~TABLET;ORAL~LORATADINE~MYLAN~10MG~A~078447~001~~Aug 12, 2011~No~OTC~M
LORATADINE~TABLET;ORAL~LORATADINE~PERRIGO~10MG~A~076301~001~~Jun 25, 2004~No~OTC
~L PERRIGO CO
LORATADINE~TABLET;ORAL~LORATADINE~PERRIGO~10MG~N~021512~001~~Jun 24, 2004~No~DIS
CN~PERRIGO CO
LORATADINE~TABLET;ORAL~LORATADINE~RANBAXY~10MG~A~076134~001~~Aug 18, 2003~No~OTC
LORATADINE~TABLET;ORAL~LORATADINE~SANDOZ~10MG~A~075209~001~~Jan 21, 2003~No~OTC~
SANDOZ INC
LORAZEPAM~TABLET;ORAL~LORAZ~QUANTUM PHARMICS~0.5MG~A~070200~001~~Aug 9, 1985~No~
DISCN~QUANTUM PHARMICS LTD
LORAZEPAM~TABLET;ORAL~LORAZ~QUANTUM PHARMICS~1MG~A~070201~001~~Aug 9, 1985~No~DI
SCN~QUANTUM PHARMICS LTD
LORAZEPAM~TABLET;ORAL~LORAZ~QUANTUM PHARMICS~2MG~A~070202~001~~Aug 9, 1985~No~DI
LORAZEPAM~TABLET;ORAL~LORAZEPAM~AM THERAP~0.5MG~A~070727~001~~Mar 7, 1986~No~DIS
CN~AMERICAN THERAPEUTICS INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~AM THERAP~1MG~A~070728~001~~Mar 7, 1986~No~DISCN
LORAZEPAM~TABLET;ORAL~LORAZEPAM~AM THERAP~2MG~A~070729~001~~Mar 7, 1986~No~DISCN
LORAZEPAM~TABLET;ORAL~LORAZEPAM~AMNEAL PHARMS~0.5MG~A~078826~001~AB~Jun 23, 2010
LORAZEPAM~TABLET;ORAL~LORAZEPAM~AMNEAL PHARMS~1MG~A~078826~002~AB~Jun 23, 2010~N
o~RX~AMNEAL PHARMACEUTICALS
LORAZEPAM~TABLET;ORAL~LORAZEPAM~AMNEAL PHARMS~2MG~A~078826~003~AB~Jun 23, 2010~N
o~RX~AMNEAL PHARMACEUTICALS
LORAZEPAM~TABLET;ORAL~LORAZEPAM~EXCELLIUM~0.5MG~A~078203~001~AB~Jul 30, 2007~No~
LORAZEPAM~TABLET;ORAL~LORAZEPAM~EXCELLIUM~1MG~A~078203~002~AB~Jul 30, 2007~No~RX
~EXCELLIUM PHARMACEUTICAL INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~EXCELLIUM~2MG~A~078203~003~AB~Jul 30, 2007~No~RX
~EXCELLIUM PHARMACEUTICAL INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~HALSEY~0.5MG~A~071434~001~~Sep 1, 1987~No~DISCN~
HALSEY DRUG CO INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~HALSEY~1MG~A~071435~001~~Sep 1, 1987~No~DISCN~HA
LSEY DRUG CO INC

LORAZEPAM~TABLET;ORAL~LORAZEPAM~HALSEY~2MG~A~071436~001~~Sep 1, 1987~No~DISCN~HA
LSEY DRUG CO INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~IVAX SUB TEVA PHARMS~0.5MG~A~077396~001~AB~Dec 1
LORAZEPAM~TABLET;ORAL~LORAZEPAM~IVAX SUB TEVA PHARMS~1MG~A~077396~002~AB~Dec 13,
LORAZEPAM~TABLET;ORAL~LORAZEPAM~IVAX SUB TEVA PHARMS~2MG~A~077396~003~AB~Dec 13,
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MUTUAL PHARM~0.5MG~A~070472~001~~Dec 10, 1985~No
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MUTUAL PHARM~0.5MG~A~072553~001~~Mar 29, 1991~No
~DISCN~MUTUAL PHARMACEUTICAL COMPANY, INC.
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MUTUAL PHARM~1MG~A~070473~001~~Dec 10, 1985~No~D
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MUTUAL PHARM~1MG~A~072554~001~~Mar 29, 1991~No~D
ISCN~MUTUAL PHARMACEUTICAL COMPANY, INC.
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MUTUAL PHARM~2MG~A~070474~001~~Dec 10, 1985~No~D
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MUTUAL PHARM~2MG~A~072555~001~~Mar 29, 1991~No~D
ISCN~MUTUAL PHARMACEUTICAL COMPANY, INC.
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MYLAN~0.5MG~A~071589~001~AB~Oct 13, 1987~No~RX~M
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MYLAN~0.5MG~A~077657~001~AB~Mar 16, 2006~No~RX~M
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MYLAN~1MG~A~071590~001~AB~Oct 13, 1987~No~RX~MYL
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MYLAN~1MG~A~077657~002~AB~Mar 16, 2006~No~RX~MYL
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MYLAN~2MG~A~071591~001~AB~Oct 13, 1987~No~RX~MYL
LORAZEPAM~TABLET;ORAL~LORAZEPAM~MYLAN~2MG~A~077657~003~AB~Mar 16, 2006~No~RX~MYL
LORAZEPAM~TABLET;ORAL~LORAZEPAM~PAR PHARM~0.5MG~A~070675~001~~Dec 1, 1986~No~DIS
LORAZEPAM~TABLET;ORAL~LORAZEPAM~PAR PHARM~1MG~A~070676~001~~Dec 1, 1986~No~DISCN
LORAZEPAM~TABLET;ORAL~LORAZEPAM~PAR PHARM~2MG~A~070677~001~~Dec 1, 1986~No~DISCN
LORAZEPAM~TABLET;ORAL~LORAZEPAM~RANBAXY~0.5MG~A~076045~001~AB~Aug 29, 2001~No~RX
LORAZEPAM~TABLET;ORAL~LORAZEPAM~RANBAXY~1MG~A~076045~002~AB~Aug 29, 2001~No~RX~R
LORAZEPAM~TABLET;ORAL~LORAZEPAM~RANBAXY~2MG~A~076045~003~AB~Aug 29, 2001~No~RX~R
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SANDOZ~0.5MG~A~071193~001~~Apr 15, 1988~No~DISCN
~SANDOZ INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SANDOZ~0.5MG~A~071403~001~AB~Apr 21, 1987~No~RX~
SANDOZ INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SANDOZ~1MG~A~071194~001~~Apr 15, 1988~No~DISCN~S
ANDOZ INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SANDOZ~1MG~A~071404~001~AB~Apr 21, 1987~No~RX~SA
NDOZ INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SANDOZ~2MG~A~071141~001~AB~Apr 21, 1987~No~RX~SA
NDOZ INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SANDOZ~2MG~A~071195~001~~Apr 15, 1988~No~DISCN~S
ANDOZ INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SUPERPHARM~0.5MG~A~071245~001~~Feb 9, 1987~No~DI
SCN~SUPERPHARM CORP
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SUPERPHARM~1MG~A~071246~001~~Feb 9, 1987~No~DISC
N~SUPERPHARM CORP
LORAZEPAM~TABLET;ORAL~LORAZEPAM~SUPERPHARM~2MG~A~071247~001~~Feb 9, 1987~No~DISC
N~SUPERPHARM CORP
LORAZEPAM~TABLET;ORAL~LORAZEPAM~USL PHARMA~1MG~A~070539~001~~Dec 22, 1986~No~DIS
CN~USL PHARMA INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~USL PHARMA~2MG~A~070540~001~~Dec 22, 1986~No~DIS
CN~USL PHARMA INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~VINTAGE PHARMS~0.5MG~A~077754~001~AB~May 10, 200
LORAZEPAM~TABLET;ORAL~LORAZEPAM~VINTAGE PHARMS~1MG~A~077754~002~AB~May 10, 2006~
No~RX~VINTAGE PHARMACEUTICALS INC
LORAZEPAM~TABLET;ORAL~LORAZEPAM~VINTAGE PHARMS~2MG~A~077754~003~AB~May 10, 2006~
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WARNER CHILCOTT~1MG~A~071038~001~~Jan 12, 1988~N
o~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WARNER CHILCOTT~2MG~A~071039~001~~Jan 12, 1988~N
o~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~0.5MG~A~071086~001~~Mar 23, 1987~No~
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~0.5MG~A~071117~001~~Jul 24, 1986~No~
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~0.5MG~A~072926~001~AB~Oct 31, 1991~N
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~1MG~A~071087~001~~Mar 23, 1987~No~DI
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~1MG~A~071118~001~~Jul 24, 1986~No~DI
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~1MG~A~072927~001~AB~Oct 31, 1991~No~
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~2MG~A~071088~001~~Mar 23, 1987~No~DI
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~2MG~A~071110~001~~Jul 24, 1986~No~DI
LORAZEPAM~TABLET;ORAL~LORAZEPAM~WATSON LABS~2MG~A~072928~001~AB~Oct 31, 1991~No~
PROBUCOL~TABLET;ORAL~LORELCO~SANOFI AVENTIS US~250MG~N~017535~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
PROBUCOL~TABLET;ORAL~LORELCO~SANOFI AVENTIS US~500MG~N~017535~002~~Jul 6, 1988~N
o~DISCN~SANOFI AVENTIS US LLC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~LORTAB~UCB INC~500MG;5MG~A~087
722~001~~Jul 9, 1982~No~DISCN~UCB INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~LORTAB~UCB INC~500MG;10MG~A~04
0100~001~~Jan 26, 1996~No~DISCN~UCB INC
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL~LORYNA~SANDOZ~3MG;0.02MG~A~079221~00
1~AB~Mar 28, 2011~No~RX~SANDOZ INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~ALEMBIC PHARMS LTD~25MG~A~0904
28~001~AB~Oct 6, 2010~No~RX~ALEMBIC PHARMACEUTICALS LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~APOTEX CORP~25MG~A~090790~001~
AB~Oct 6, 2010~No~RX~APOTEX CORP
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~APOTEX CORP~50MG~A~090790~002~
AB~Oct 6, 2010~No~RX~APOTEX CORP
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~APOTEX CORP~100MG~A~090790~003
~AB~Oct 6, 2010~No~RX~APOTEX CORP
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~AUROBINDO PHARMA~25MG~A~090083
~001~AB~Oct 6, 2010~No~RX~AUROBINDO PHARMA LTD
~002~AB~Oct 6, 2010~No~RX~AUROBINDO PHARMA LTD

3~003~AB~Oct 6, 2010~No~RX~AUROBINDO PHARMA LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~CADISTA PHARMS~25MG~A~201170~0
01~AB~Sep 18, 2012~No~RX~CADISTA PHARMACEUTICALS INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~CADISTA PHARMS~50MG~A~201170~0
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~CADISTA PHARMS~100MG~A~201170~
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~IPCA LABS LTD~25MG~A~200290~00
1~AB~Aug 30, 2013~No~RX~IPCA LABORATORIES LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~LUPIN LTD~25MG~A~078232~001~AB
~Oct 6, 2010~No~RX~LUPIN LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~LUPIN LTD~50MG~A~078232~002~AB
~Oct 6, 2010~No~RX~LUPIN LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~LUPIN LTD~100MG~A~078232~003~A
B~Oct 6, 2010~No~RX~LUPIN LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~MACLEODS PHARMS LTD~25MG~A~202
230~001~AB~May 30, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~MICRO LABS LTD INDIA~25MG~A~09
1541~001~AB~Sep 24, 2012~No~RX~MICRO LABS LTD INDIA
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~MYLAN~25MG~A~091590~001~AB~Oct
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~MYLAN~50MG~A~091590~002~AB~Oct
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~MYLAN~100MG~A~091590~003~AB~Oc
t 6, 2010~No~RX~MYLAN PHARMACEUTICALS INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~PRINSTON INC~25MG~A~091497~001
~AB~Jun 6, 2011~No~RX~PRINSTON PHARMACEUTICAL INC
~AB~Jun 6, 2011~No~RX~PRINSTON PHARMACEUTICAL INC
3~AB~Jun 6, 2011~No~RX~PRINSTON PHARMACEUTICAL INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~ROXANE~25MG~A~077459~001~AB~Oc
t 6, 2010~No~RX~ROXANE LABORATORIES INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~ROXANE~50MG~A~077459~002~AB~Oc
t 6, 2010~No~RX~ROXANE LABORATORIES INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~ROXANE~100MG~A~077459~003~AB~O
ct 6, 2010~No~RX~ROXANE LABORATORIES INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~SANDOZ~25MG~A~077424~001~AB~Oc
t 6, 2010~No~RX~SANDOZ INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~SANDOZ~50MG~A~077424~002~AB~Oc
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~SANDOZ~100MG~A~077424~003~AB~O
ct 6, 2010~No~RX~SANDOZ INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~TEVA~25MG~A~076958~001~AB~Apr

LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~TORRENT PHARMS~25MG~A~090467~0
01~AB~Oct 6, 2010~No~RX~TORRENT PHARMACEUTICALS LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~TORRENT PHARMS~50MG~A~090467~0
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~TORRENT PHARMS~100MG~A~090467~
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~UPSHER SMITH~25MG~A~090544~001
~AB~Oct 6, 2010~No~RX~UPSHER SMITH LABORATORIES INC
~AB~Oct 6, 2010~No~RX~UPSHER SMITH LABORATORIES INC
3~AB~Oct 6, 2010~No~RX~UPSHER SMITH LABORATORIES INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~VIVIMED LABS~25MG~A~090382~001
~AB~Oct 6, 2010~No~RX~VIVIMED LABS ALATHUR PRIVATE LTD
~AB~Oct 6, 2010~No~RX~VIVIMED LABS ALATHUR PRIVATE LTD
3~AB~Oct 6, 2010~No~RX~VIVIMED LABS ALATHUR PRIVATE LTD
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~WATSON LABS~25MG~A~091129~001~
AB~Oct 6, 2010~No~RX~WATSON LABORATORIES INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~WATSON LABS~50MG~A~091129~002~
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~WATSON LABS~100MG~A~091129~003
~AB~Oct 6, 2010~No~RX~WATSON LABORATORIES INC
LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM~ZYDUS PHARMS USA INC~25MG~A~07
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM~TABLET;ORAL~LOSARTAN POTASSIUM AND HYDRO
CHLOROTHIAZIDE~ALEMBIC PHARMS LTD~12.5MG;50MG~A~091617~001~AB~Feb 17, 2012~No~RX
~ALEMBIC PHARMACEUTICALS LTD
CHLOROTHIAZIDE~ALEMBIC PHARMS LTD~12.5MG;100MG~A~091617~002~AB~Feb 17, 2012~No~R
X~ALEMBIC PHARMACEUTICALS LTD
CHLOROTHIAZIDE~ALEMBIC PHARMS LTD~25MG;100MG~A~091617~003~AB~Feb 17, 2012~No~RX~
ALEMBIC PHARMACEUTICALS LTD
CHLOROTHIAZIDE~APOTEX~12.5MG;50MG~A~090150~001~AB~Oct 6, 2010~No~RX~APOTEX CORP
CHLOROTHIAZIDE~APOTEX~12.5MG;100MG~A~090150~002~AB~Aug 11, 2010~No~RX~APOTEX COR
P
CHLOROTHIAZIDE~APOTEX~25MG;100MG~A~090150~003~AB~Oct 6, 2010~No~RX~APOTEX CORP
CHLOROTHIAZIDE~AUROBINDO PHARMA~12.5MG;50MG~A~091629~001~AB~Oct 6, 2010~No~RX~AU
ROBINDO PHARMA LTD
CHLOROTHIAZIDE~AUROBINDO PHARMA~12.5MG;100MG~A~091629~002~AB~Oct 6, 2010~No~RX~A
UROBINDO PHARMA LTD
CHLOROTHIAZIDE~AUROBINDO PHARMA~25MG;100MG~A~091629~003~AB~Jan 6, 2010~No~RX~AUR
OBINDO PHARMA LTD
CHLOROTHIAZIDE~CADISTA PHARMS~12.5MG;50MG~A~201845~001~AB~Sep 18, 2012~No~RX~CAD
ISTA PHARMACEUTICALS INC

CHLOROTHIAZIDE~CADISTA PHARMS~12.5MG;100MG~A~201845~002~AB~Sep 18, 2012~No~RX~CA
DISTA PHARMACEUTICALS INC
CHLOROTHIAZIDE~CADISTA PHARMS~25MG;100MG~A~201845~003~AB~Sep 18, 2012~No~RX~CADI
STA PHARMACEUTICALS INC
CHLOROTHIAZIDE~IPCA LABS LTD~12.5MG;50MG~A~201682~001~AB~Mar 1, 2013~No~RX~IPCA
LABORATORIES LTD
CHLOROTHIAZIDE~IPCA LABS LTD~12.5MG;100MG~A~201682~002~AB~Mar 1, 2013~No~RX~IPCA
LABORATORIES LTD
CHLOROTHIAZIDE~IPCA LABS LTD~25MG;100MG~A~201682~003~AB~Mar 1, 2013~No~RX~IPCA L
ABORATORIES LTD
CHLOROTHIAZIDE~LUPIN LTD~12.5MG;50MG~A~078245~001~AB~Oct 6, 2010~No~RX~LUPIN LTD
CHLOROTHIAZIDE~LUPIN LTD~12.5MG;100MG~A~078245~002~AB~May 21, 2010~No~RX~LUPIN L
TD
CHLOROTHIAZIDE~LUPIN LTD~25MG;100MG~A~078245~003~AB~Oct 6, 2010~No~RX~LUPIN LTD
CHLOROTHIAZIDE~MACLEODS PHARMS LTD~12.5MG;50MG~A~202289~001~AB~Aug 9, 2012~No~RX
~MACLEODS PHARMACEUTICALS LTD
CHLOROTHIAZIDE~MACLEODS PHARMS LTD~12.5MG;100MG~A~202289~002~AB~Aug 9, 2012~No~R
X~MACLEODS PHARMACEUTICALS LTD
CHLOROTHIAZIDE~MACLEODS PHARMS LTD~25MG;100MG~A~202289~003~AB~Aug 9, 2012~No~RX~
MACLEODS PHARMACEUTICALS LTD
CHLOROTHIAZIDE~MYLAN~12.5MG;50MG~A~091652~001~AB~Oct 6, 2010~No~RX~MYLAN PHARMAC
EUTICALS INC
CHLOROTHIAZIDE~MYLAN~12.5MG;100MG~A~091652~002~AB~Apr 6, 2010~No~RX~MYLAN PHARMA
CEUTICALS INC
CHLOROTHIAZIDE~MYLAN~25MG;100MG~A~091652~003~AB~Oct 6, 2010~No~RX~MYLAN PHARMACE
UTICALS INC
CHLOROTHIAZIDE~ROXANE~12.5MG;50MG~A~077732~002~AB~Oct 6, 2010~No~RX~ROXANE LABOR
ATORIES INC
CHLOROTHIAZIDE~ROXANE~12.5MG;100MG~A~077732~001~AB~Apr 6, 2010~No~RX~ROXANE LABO
RATORIES INC
CHLOROTHIAZIDE~ROXANE~25MG;100MG~A~077732~003~AB~Oct 6, 2010~No~RX~ROXANE LABORA
TORIES INC
CHLOROTHIAZIDE~SANDOZ~12.5MG;50MG~A~077948~001~AB~Oct 6, 2010~No~RX~SANDOZ INC
CHLOROTHIAZIDE~SANDOZ~12.5MG;100MG~A~077948~003~AB~Aug 19, 2010~No~RX~SANDOZ INC
CHLOROTHIAZIDE~SANDOZ~25MG;100MG~A~077948~002~AB~Oct 6, 2010~No~RX~SANDOZ INC
CHLOROTHIAZIDE~TEVA PHARMS~12.5MG;50MG~A~077157~001~AB~Apr 6, 2010~No~RX~TEVA PH
ARMACEUTICALS USA
CHLOROTHIAZIDE~TEVA PHARMS~12.5MG;100MG~A~077157~002~AB~Apr 6, 2010~No~RX~TEVA P

HARMACEUTICALS USA
CHLOROTHIAZIDE~TEVA PHARMS~25MG;100MG~A~077157~003~AB~Apr 6, 2010~No~RX~TEVA PHA
RMACEUTICALS USA
CHLOROTHIAZIDE~TORRENT PHARMS~12.5MG;50MG~A~090528~001~AB~Oct 6, 2010~No~RX~TORR
ENT PHARMACEUTICALS LTD
CHLOROTHIAZIDE~TORRENT PHARMS~12.5MG;100MG~A~090528~003~AB~Apr 6, 2010~No~RX~TOR
RENT PHARMACEUTICALS LTD
CHLOROTHIAZIDE~TORRENT PHARMS~25MG;100MG~A~090528~002~AB~Oct 6, 2010~No~RX~TORRE
NT PHARMACEUTICALS LTD
CHLOROTHIAZIDE~WATSON LABS~12.5MG;50MG~A~200180~001~~Jan 12, 2011~No~DISCN~WATSO
N LABORATORIES INC
CHLOROTHIAZIDE~WATSON LABS~12.5MG;100MG~A~200180~002~~Jan 12, 2011~No~DISCN~WATS
ON LABORATORIES INC
CHLOROTHIAZIDE~WATSON LABS~25MG;100MG~A~200180~003~~Jan 12, 2011~No~DISCN~WATSON
LABORATORIES INC
CHLOROTHIAZIDE~ZYDUS PHARMS USA INC~12.5MG;50MG~A~078385~001~AB~Oct 6, 2010~No~R
X~ZYDUS PHARMACEUTICALS USA INC
CHLOROTHIAZIDE~ZYDUS PHARMS USA INC~25MG;100MG~A~078385~002~AB~Oct 6, 2010~No~RX
~ZYDUS PHARMACEUTICALS USA INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~LOSEASONIQUE~TEVA BRANDED PHARM~0.
02MG,0.01MG;0.1MG,N/A~N~022262~001~AB~Oct 24, 2008~No~RX~TEVA BRANDED PHARMACEUT
ICAL PRODUCTS R AND D INC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~LOTENSIN~US PHARMS HOLDINGS I~5MG~N~019851~
001~AB~Jun 25, 1991~No~RX~US PHARMACEUTICALS HOLDINGS I LLC
BENAZEPRIL HYDROCHLORIDE~TABLET;ORAL~LOTENSIN~US PHARMS HOLDINGS I~10MG~N~019851
~002~AB~Jun 25, 1991~No~RX~US PHARMACEUTICALS HOLDINGS I LLC
~003~AB~Jun 25, 1991~No~RX~US PHARMACEUTICALS HOLDINGS I LLC
~004~AB~Jun 25, 1991~Yes~RX~US PHARMACEUTICALS HOLDINGS I LLC
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~LOTENSIN HCT~US PHARMS
HOLDINGS I~5MG;6.25MG~N~020033~001~AB~May 19, 1992~No~RX~US PHARMACEUTICALS HOL
DINGS I LLC
HOLDINGS I~10MG;12.5MG~N~020033~002~AB~May 19, 1992~No~RX~US PHARMACEUTICALS HO
LDINGS I LLC
HOLDINGS I~20MG;12.5MG~N~020033~004~AB~May 19, 1992~No~RX~US PHARMACEUTICALS HO
LDINGS I LLC
HOLDINGS I~20MG;25MG~N~020033~003~AB~May 19, 1992~Yes~RX~US PHARMACEUTICALS HOL
DINGS I LLC
ALOSETRON HYDROCHLORIDE~TABLET;ORAL~LOTRONEX~PROMETHEUS LABS~EQ 0.5MG BASE~N~021
107~002~~Dec 23, 2003~No~RX~PROMETHEUS LABORATORIES INC
ALOSETRON HYDROCHLORIDE~TABLET;ORAL~LOTRONEX~PROMETHEUS LABS~EQ 1MG BASE~N~02110
7~001~~Feb 9, 2000~Yes~RX~PROMETHEUS LABORATORIES INC
TALBUTAL~TABLET;ORAL~LOTUSATE~SANOFI AVENTIS US~120MG~N~009410~005~~Approved Pri
or to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
LOVASTATIN~TABLET;ORAL~LOVASTATIN~ACTAVIS ELIZABETH~10MG~A~075828~001~AB~Dec 17,

LOVASTATIN~TABLET;ORAL~LOVASTATIN~APOTEX INC~10MG~A~077748~001~AB~Feb 28, 2007~N
o~RX~APOTEX INC
o~RX~APOTEX INC
o~RX~APOTEX INC
LOVASTATIN~TABLET;ORAL~LOVASTATIN~CARLSBAD~10MG~A~075991~001~AB~Jun 5, 2002~No~R
LOVASTATIN~TABLET;ORAL~LOVASTATIN~CARLSBAD~20MG~A~075991~002~AB~Jun 5, 2002~No~R
LOVASTATIN~TABLET;ORAL~LOVASTATIN~CARLSBAD~40MG~A~075991~003~AB~Jun 5, 2002~Yes~
LOVASTATIN~TABLET;ORAL~LOVASTATIN~LUPIN~10MG~A~078296~001~AB~Mar 14, 2008~No~RX~
LUPIN LTD
LOVASTATIN~TABLET;ORAL~LOVASTATIN~LUPIN~20MG~A~078296~002~AB~Nov 1, 2007~No~RX~L
UPIN LTD
LOVASTATIN~TABLET;ORAL~LOVASTATIN~LUPIN~40MG~A~078296~003~AB~Nov 1, 2007~No~RX~L
UPIN LTD
LOVASTATIN~TABLET;ORAL~LOVASTATIN~MUTUAL PHARM~10MG~A~077520~001~AB~Apr 14, 2006
~No~RX~MUTUAL PHARMACEUTICAL CO INC
LOVASTATIN~TABLET;ORAL~LOVASTATIN~MYLAN~10MG~A~075451~001~AB~Dec 17, 2001~No~RX~
LOVASTATIN~TABLET;ORAL~LOVASTATIN~SANDOZ~10MG~A~075300~001~AB~Dec 17, 2001~No~RX
~SANDOZ INC
~SANDOZ INC
~SANDOZ INC
~SANDOZ INC
~SANDOZ INC
~SANDOZ INC
LOVASTATIN~TABLET;ORAL~LOVASTATIN~TEVA~10MG~A~075551~003~AB~Dec 17, 2001~No~RX~T
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE~TABLET;ORAL~LOW-QUEL~HALSEY~0.025M
G;2.5MG~A~085211~001~~Approved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
LOXAPINE SUCCINATE~TABLET;ORAL~LOXITANE~WATSON LABS~EQ 10MG BASE~N~017525~006~~A

INDAPAMIDE~TABLET;ORAL~LOZOL~SANOFI AVENTIS US~1.25MG **Federal Register determi
nation that product was not discontinued or withdrawn for safety or efficacy rea
sons**~N~018538~002~~Apr 29, 1993~No~DISCN~SANOFI AVENTIS US LLC
INDAPAMIDE~TABLET;ORAL~LOZOL~SANOFI AVENTIS US~2.5MG **Federal Register determin
ation that product was not discontinued or withdrawn for safety or efficacy reas
ons**~N~018538~001~~Jul 6, 1983~No~DISCN~SANOFI AVENTIS US LLC
MAPROTILINE HYDROCHLORIDE~TABLET;ORAL~LUDIOMIL~NOVARTIS~25MG~N~017543~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
MAPROTILINE HYDROCHLORIDE~TABLET;ORAL~LUDIOMIL~NOVARTIS~50MG~N~017543~002~~Appro
ved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
MAPROTILINE HYDROCHLORIDE~TABLET;ORAL~LUDIOMIL~NOVARTIS~75MG~N~017543~003~~Sep 3
DYPHYLLINE~TABLET;ORAL~LUFYLLIN~MEDA PHARMS~200MG~A~084566~001~~Approved Prior t
o Jan 1, 1982~No~RX~MEDA PHARMACEUTICALS INC
DYPHYLLINE~TABLET;ORAL~LUFYLLIN~MEDA PHARMS~400MG~A~084566~002~~Approved Prior t
o Jan 1, 1982~Yes~RX~MEDA PHARMACEUTICALS INC
ESZOPICLONE~TABLET;ORAL~LUNESTA~SUNOVION PHARMS INC~1MG~N~021476~001~AB~Dec 15,
2004~No~RX~SUNOVION PHARMACEUTICALS INC
2004~No~RX~SUNOVION PHARMACEUTICALS INC
2004~Yes~RX~SUNOVION PHARMACEUTICALS INC
FLUVOXAMINE MALEATE~TABLET;ORAL~LUVOX~ANI PHARMS~25MG~N~021519~001~AB~Dec 20, 20
FLUVOXAMINE MALEATE~TABLET;ORAL~LUVOX~SOLVAY~25MG~N~020243~001~~Dec 5, 1994~No~D
ISCN~SOLVAY PHARMACEUTICALS
FLUVOXAMINE MALEATE~TABLET;ORAL~LUVOX~SOLVAY~50MG~N~020243~002~~Dec 5, 1994~No~D
ISCN~SOLVAY PHARMACEUTICALS
FLUVOXAMINE MALEATE~TABLET;ORAL~LUVOX~SOLVAY~100MG~N~020243~003~~Dec 5, 1994~No~
FLUVOXAMINE MALEATE~TABLET;ORAL~LUVOX~SOLVAY~150MG~N~020243~004~~Dec 5, 1994~No~
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~LYBREL~WYETH PHARMS INC~0.02MG;0.0
9MG **Federal Register determination that product was not discontinued or withdr
awn for safety or efficacy reasons**~N~021864~001~~May 22, 2007~No~DISCN~WYETH P
HARMACEUTICALS INC
ETHINYL ESTRADIOL~TABLET;ORAL~LYNORAL~ORGANON USA INC~0.01MG~N~005490~003~~Appro
ETHINYL ESTRADIOL~TABLET;ORAL~LYNORAL~ORGANON USA INC~0.05MG~N~005490~002~~Appro
MITOTANE~TABLET;ORAL~LYSODREN~BRISTOL MYERS SQUIBB~500MG~N~016885~001~~Approved
Prior to Jan 1, 1982~Yes~RX~BRISTOL MYERS SQUIBB
TRANEXAMIC ACID~TABLET;ORAL~LYSTEDA~FERRING PHARMS AS~650MG~N~022430~001~AB~Nov
13, 2009~Yes~RX~FERRING PHARMACEUTICALS AS
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE~TABLET;ORAL~MAGNESIUM HYDROX
IDE AND OMEPRAZOLE AND SODIUM BICARBONATE~SANTARUS~343MG;20MG;750MG~N~022456~001
~~Dec 4, 2009~No~DISCN~SANTARUS INC
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE~TABLET;ORAL~MAGNESIUM HYDROX
IDE AND OMEPRAZOLE AND SODIUM BICARBONATE~SANTARUS~343MG;40MG;750MG~N~022456~002
~~Dec 4, 2009~No~DISCN~SANTARUS INC
ATOVAQUONE; PROGUANIL HYDROCHLORIDE~TABLET;ORAL~MALARONE~GLAXOSMITHKLINE~250MG;1

00MG~N~021078~001~AB~Jul 14, 2000~Yes~RX~GLAXOSMITHKLINE
ATOVAQUONE; PROGUANIL HYDROCHLORIDE~TABLET;ORAL~MALARONE PEDIATRIC~GLAXOSMITHKLI
NE~62.5MG;25MG~N~021078~002~AB~Jul 14, 2000~No~RX~GLAXOSMITHKLINE
CHLORPHENESIN CARBAMATE~TABLET;ORAL~MAOLATE~PHARMACIA AND UPJOHN~400MG~N~014217~
MAPROTILINE HYDROCHLORIDE~TABLET;ORAL~MAPROTILINE HYDROCHLORIDE~AM THERAP~25MG~A
~072129~001~~Jan 14, 1988~No~DISCN~AMERICAN THERAPEUTICS INC
MAPROTILINE HYDROCHLORIDE~TABLET;ORAL~MAPROTILINE HYDROCHLORIDE~MYLAN~25MG~A~072
285~002~~Oct 3, 1988~No~RX~MYLAN PHARMACEUTICALS INC
285~001~~Oct 3, 1988~Yes~RX~MYLAN PHARMACEUTICALS INC
285~003~~Oct 3, 1988~No~RX~MYLAN PHARMACEUTICALS INC
MAPROTILINE HYDROCHLORIDE~TABLET;ORAL~MAPROTILINE HYDROCHLORIDE~WATSON LABS~25MG
~A~071943~001~~Dec 30, 1987~No~DISCN~WATSON LABORATORIES INC
~A~072162~001~~Jun 1, 1988~No~DISCN~WATSON LABORATORIES INC
ISOCARBOXAZID~TABLET;ORAL~MARPLAN~VALIDUS PHARMS INC~10MG~N~011961~001~~Approved
Prior to Jan 1, 1982~Yes~RX~VALIDUS PHARMACEUTICALS INC
TRANDOLAPRIL~TABLET;ORAL~MAVIK~ABBVIE~1MG~N~020528~001~AB~Apr 26, 1996~No~RX~ABB
VIE INC
TRANDOLAPRIL~TABLET;ORAL~MAVIK~ABBVIE~2MG~N~020528~002~AB~Apr 26, 1996~No~RX~ABB
VIE INC
TRANDOLAPRIL~TABLET;ORAL~MAVIK~ABBVIE~4MG~N~020528~003~AB~Apr 26, 1996~Yes~RX~AB
BVIE INC
RIZATRIPTAN BENZOATE~TABLET;ORAL~MAXALT~MERCK~EQ 5MG BASE~N~020864~001~AB~Jun 29
, 1998~No~RX~MERCK AND CO INC
RIZATRIPTAN BENZOATE~TABLET;ORAL~MAXALT~MERCK~EQ 10MG BASE~N~020864~002~AB~Jun 2
9, 1998~Yes~RX~MERCK AND CO INC
LOMEFLOXACIN HYDROCHLORIDE~TABLET;ORAL~MAXAQUIN~PHARMACIA~EQ 400MG BASE~N~020013
~001~~Feb 21, 1992~No~DISCN~PHARMACIA CORP
ETHYLESTRENOL~TABLET;ORAL~MAXIBOLIN~ORGANON USA INC~2MG~N~014005~002~~Approved P
rior to Jan 1, 1982~No~DISCN~ORGANON USA INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~MAXOLON~KING PHARMS~EQ 10MG BASE~A~0701
06~001~~Mar 4, 1986~No~DISCN~KING PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; TRIAMTERENE~TABLET;ORAL~MAXZIDE~MYLAN PHARMS INC~50MG;75MG~
N~019129~001~AB~Oct 22, 1984~Yes~RX~MYLAN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; TRIAMTERENE~TABLET;ORAL~MAXZIDE-25~MYLAN PHARMS INC~25MG;37
.5MG~N~019129~003~AB~May 13, 1988~No~RX~MYLAN PHARMACEUTICALS INC
MAZINDOL~TABLET;ORAL~MAZANOR~WYETH AYERST~1MG~N~017980~002~~Approved Prior to Ja
MAZINDOL~TABLET;ORAL~MAZANOR~WYETH AYERST~2MG~N~017980~001~~Approved Prior to Ja
MECAMYLAMINE HYDROCHLORIDE~TABLET;ORAL~MECAMYLAMINE HYDROCHLORIDE~NEXGEN PHARMA~
2.5MG~A~204054~001~~Mar 19, 2013~No~RX~NEXGEN PHARMA INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~ABC HOLDING~12.5MG~A
~085253~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABC HOLDING CORP
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~ABC HOLDING~25MG~A~0

85252~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABC HOLDING CORP
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~AMNEAL PHARMS~12.5MG
~A~201451~001~AA~Feb 23, 2011~No~RX~AMNEAL PHARMACEUTICALS
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~AMNEAL PHARMS~25MG~A
~201451~002~AA~Feb 23, 2011~No~RX~AMNEAL PHARMACEUTICALS
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~AMNEAL PHARMS~50MG~A
~201451~003~~Feb 23, 2011~No~DISCN~AMNEAL PHARMACEUTICALS
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~ANABOLIC~25MG~A~0858
91~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANABOLIC INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~BUNDY~12.5MG~A~08438
2~001~~Approved Prior to Jan 1, 1982~No~DISCN~CM BUNDY CO
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~BUNDY~25MG~A~084872~
001~~Approved Prior to Jan 1, 1982~No~DISCN~CM BUNDY CO
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~EPIC PHARMA LLC~12.5
MG~A~200294~001~AA~Apr 13, 2012~No~RX~EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~EPIC PHARMA LLC~25MG
~A~200294~002~AA~Apr 13, 2012~No~RX~EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~IVAX SUB TEVA PHARMS
~12.5MG~A~083784~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICAL
~12.5MG~A~084975~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICAL
~25MG~A~084657~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~JUBILANT CADISTA~12.
5MG~A~040659~001~AA~Jun 4, 2010~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~JUBILANT CADISTA~25M
G~A~040659~002~AA~Jun 4, 2010~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~KV PHARM~12.5MG~A~08
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~KV PHARM~25MG~A~0855
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~MYLAN PHARMS INC~12.
5MG~A~202640~001~AA~Sep 17, 2012~No~RX~MYLAN PHARMACEUTICALS INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~MYLAN PHARMS INC~25M
G~A~202640~002~AA~Sep 17, 2012~No~RX~MYLAN PHARMACEUTICALS INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~MYLAN PHARMS INC~50M
G~A~202640~003~~Sep 17, 2012~No~DISCN~MYLAN PHARMACEUTICALS INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~PAR PHARM~12.5MG~A~0
87127~001~AA~Approved Prior to Jan 1, 1982~No~RX~PAR PHARMACEUTICAL INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~PAR PHARM~25MG~A~087
128~001~AA~Approved Prior to Jan 1, 1982~No~RX~PAR PHARMACEUTICAL INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~PAR PHARM~50MG~A~089
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~PLIVA~12.5MG~A~08873
2~001~~Dec 11, 1985~No~DISCN~PLIVA INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~PLIVA~25MG~A~088734~
001~~Dec 11, 1985~No~DISCN~PLIVA INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~SANDOZ~12.5MG~A~0848
43~002~AA~May 22, 1989~No~RX~SANDOZ INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~SANDOZ~25MG~A~084092
~003~AA~May 22, 1989~No~RX~SANDOZ INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~SUPERPHARM~12.5MG~A~
089113~001~~Aug 20, 1985~No~DISCN~SUPERPHARM CORP
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~SUPERPHARM~25MG~A~08
9114~001~~Aug 20, 1985~No~DISCN~SUPERPHARM CORP
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~UDL~12.5MG~A~088256~
001~~Jun 13, 1983~No~DISCN~UDL LABORATORIES INC

MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~UDL~25MG~A~088257~00
1~~Jun 13, 1983~No~DISCN~UDL LABORATORIES INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~VANGARD~12.5MG~A~087
877~001~~Apr 20, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~VANGARD~25MG~A~08762
0~001~~Jan 4, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~VINTAGE PHARMS~12.5M
G~A~040179~001~AA~Jan 30, 1997~No~RX~VINTAGE PHARMACEUTICALS INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~VINTAGE PHARMS~25MG~
A~040179~002~AA~Jan 30, 1997~No~RX~VINTAGE PHARMACEUTICALS INC
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~WATSON LABS~12.5MG~A
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~WATSON LABS~12.5MG~A
MECLIZINE HYDROCHLORIDE~TABLET;ORAL~MECLIZINE HYDROCHLORIDE~WATSON LABS~25MG~A~0
IBUPROFEN~TABLET;ORAL~MEDIPREN~MCNEIL~200MG~A~070475~001~~Feb 6, 1986~No~DISCN~M
CNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
IBUPROFEN~TABLET;ORAL~MEDIPREN~MCNEIL~200MG~A~071215~001~~Jun 26, 1986~No~DISCN~
MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
METHYLPREDNISOLONE~TABLET;ORAL~MEDROL~PHARMACIA AND UPJOHN~2MG~N~011153~002~AB~A
pproved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
METHYLPREDNISOLONE~TABLET;ORAL~MEDROL~PHARMACIA AND UPJOHN~16MG~N~011153~003~AB~
Approved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
METHYLPREDNISOLONE~TABLET;ORAL~MEDROL~PHARMACIA AND UPJOHN~24MG~N~011153~005~~Ap
METHYLPREDNISOLONE~TABLET;ORAL~MEDROL~PHARMACIA AND UPJOHN~32MG~N~011153~006~AB~
Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~MEDROXYPROGESTERONE ACETATE~BARR~2.5MG~A
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~MEDROXYPROGESTERONE ACETATE~BARR~5MG~A~0
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~MEDROXYPROGESTERONE ACETATE~BARR~10MG~A~
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~MEDROXYPROGESTERONE ACETATE~DURAMED PHAR
MS BARR~2.5MG~A~040311~001~~Dec 1, 1999~No~DISCN~DURAMED PHARMACEUTICALS INC SUB
MS BARR~5MG~A~040311~002~~Dec 1, 1999~No~DISCN~DURAMED PHARMACEUTICALS INC SUB B
MS BARR~10MG~A~040311~003~~Dec 1, 1999~No~DISCN~DURAMED PHARMACEUTICALS INC SUB
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~MEDROXYPROGESTERONE ACETATE~USL PHARMA~1
0MG~A~088484~001~~Jul 26, 1984~No~DISCN~USL PHARMA INC
MEFLOQUINE HYDROCHLORIDE~TABLET;ORAL~MEFLOQUINE HYDROCHLORIDE~BARR~250MG~A~07639
2~001~AB~Dec 29, 2003~No~RX~BARR LABORATORIES INC
MEFLOQUINE HYDROCHLORIDE~TABLET;ORAL~MEFLOQUINE HYDROCHLORIDE~HIKMA PHARMS LLC~2
50MG~A~077699~001~~Apr 21, 2010~No~DISCN~HIKMA PHARMACEUTICALS LLC
MEFLOQUINE HYDROCHLORIDE~TABLET;ORAL~MEFLOQUINE HYDROCHLORIDE~ROXANE~250MG~A~076
523~001~AB~Oct 1, 2004~No~RX~ROXANE LABORATORIES INC
MEFLOQUINE HYDROCHLORIDE~TABLET;ORAL~MEFLOQUINE HYDROCHLORIDE~SANDOZ~250MG~A~076
175~001~AB~Feb 20, 2002~Yes~RX~SANDOZ INC
MEFLOQUINE HYDROCHLORIDE~TABLET;ORAL~MEFLOQUINE HYDROCHLORIDE~US ARMY WALTER REE
D~250MG~N~019578~001~~May 2, 1989~No~DISCN~UNITED STATES ARMY WALTER REED ARMY I
NSTITUTE RESEARCH
MEGESTROL ACETATE~TABLET;ORAL~MEGACE~BRISTOL MYERS SQUIBB~20MG~N~016979~001~~App
MEGESTROL ACETATE~TABLET;ORAL~MEGACE~BRISTOL MYERS SQUIBB~40MG~N~016979~002~~App
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~BARR~20MG~A~074621~002~AB~Aug 16
, 1996~No~RX~BARR LABORATORIES INC
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~BARR~40MG~A~074621~001~AB~Nov 30
, 1995~No~RX~BARR LABORATORIES INC
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~PAR PHARM~20MG~A~072422~001~AB~A
ug 8, 1988~No~RX~PAR PHARMACEUTICAL INC
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~PAR PHARM~40MG~A~072423~001~AB~A
ug 8, 1988~Yes~RX~PAR PHARMACEUTICAL INC
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~ROXANE~20MG~A~074458~001~AB~Sep
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~ROXANE~40MG~A~074458~002~AB~Sep
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~TEVA~40MG~A~074745~001~~Feb 27,
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~USL PHARMA~20MG~A~070646~001~~Oc
t 2, 1987~No~DISCN~USL PHARMA INC
MEGESTROL ACETATE~TABLET;ORAL~MEGESTROL ACETATE~USL PHARMA~40MG~A~070647~001~~Oc
t 2, 1987~No~DISCN~USL PHARMA INC
TRAMETINIB DIMETHYL SULFOXIDE~TABLET;ORAL~MEKINIST~GLAXOSMITHKLINE LLC~EQ 0.5MG
NON-SOLVATED PARENT~N~204114~001~~May 29, 2013~No~RX~GLAXOSMITHKLINE LLC
TRAMETINIB DIMETHYL SULFOXIDE~TABLET;ORAL~MEKINIST~GLAXOSMITHKLINE LLC~EQ 1MG NO
N-SOLVATED PARENT~N~204114~002~~May 29, 2013~No~RX~GLAXOSMITHKLINE LLC
TRAMETINIB DIMETHYL SULFOXIDE~TABLET;ORAL~MEKINIST~GLAXOSMITHKLINE LLC~EQ 2MG NO
N-SOLVATED PARENT~N~204114~003~~May 29, 2013~Yes~RX~GLAXOSMITHKLINE LLC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~MELFIAT~NUMARK~35MG~A~083790~002~~Approved
Prior to Jan 1, 1982~No~DISCN~NUMARK LABORATORIES INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~MELLARIL~NOVARTIS~10MG~N~011808~003~~Appr
oved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~MELLARIL~NOVARTIS~100MG~N~011808~009~~App
MELOXICAM~TABLET;ORAL~MELOXICAM~APOTEX INC~7.5MG~A~077882~001~AB~Jul 20, 2006~No
MELOXICAM~TABLET;ORAL~MELOXICAM~APOTEX INC~15MG~A~077882~002~AB~Jul 20, 2006~No~
RX~APOTEX INC ETOBICOKE SITE
MELOXICAM~TABLET;ORAL~MELOXICAM~AUROBINDO PHARMA~7.5MG~A~078008~001~AB~Oct 2, 20
MELOXICAM~TABLET;ORAL~MELOXICAM~AUROBINDO PHARMA~15MG~A~078008~002~AB~Oct 2, 200
MELOXICAM~TABLET;ORAL~MELOXICAM~BRECKENRIDGE PHARM~7.5MG~A~077920~001~AB~Jul 19,
2006~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
MELOXICAM~TABLET;ORAL~MELOXICAM~BRECKENRIDGE PHARM~15MG~A~077920~002~AB~Jul 19,
2006~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
MELOXICAM~TABLET;ORAL~MELOXICAM~CARLSBAD~7.5MG~A~077918~001~AB~Dec 7, 2006~No~RX
~CARLSBAD TECHNOLOGY INC
MELOXICAM~TABLET;ORAL~MELOXICAM~CARLSBAD~15MG~A~077918~002~AB~Dec 7, 2006~No~RX~
CARLSBAD TECHNOLOGY INC

MELOXICAM~TABLET;ORAL~MELOXICAM~CIPLA LTD~7.5MG~A~077929~001~AB~Jul 19, 2006~No~
RX~CIPLA LTD
MELOXICAM~TABLET;ORAL~MELOXICAM~CIPLA LTD~15MG~A~077929~002~AB~Jul 19, 2006~No~R
X~CIPLA LTD
MELOXICAM~TABLET;ORAL~MELOXICAM~COREPHARMA~7.5MG~A~077930~001~~Jul 19, 2006~No~D
ISCN~COREPHARMA LLC
MELOXICAM~TABLET;ORAL~MELOXICAM~COREPHARMA~15MG~A~077930~002~~Jul 19, 2006~No~DI
SCN~COREPHARMA LLC
MELOXICAM~TABLET;ORAL~MELOXICAM~CR DOUBLE CRANE~7.5MG~A~078039~001~~Dec 14, 2006
~No~DISCN~CHINA RESOURCES DOUBLE CRANE PHARMACEUTICAL CO LTD
MELOXICAM~TABLET;ORAL~MELOXICAM~CR DOUBLE CRANE~15MG~A~078039~002~~Dec 14, 2006~
No~DISCN~CHINA RESOURCES DOUBLE CRANE PHARMACEUTICAL CO LTD
MELOXICAM~TABLET;ORAL~MELOXICAM~DR REDDYS LABS INC~7.5MG~A~077931~001~AB~Jul 25,
MELOXICAM~TABLET;ORAL~MELOXICAM~DR REDDYS LABS INC~15MG~A~077931~002~AB~Jul 25,
MELOXICAM~TABLET;ORAL~MELOXICAM~GLENMARK GENERICS~7.5MG~A~077932~001~AB~Jul 19,
MELOXICAM~TABLET;ORAL~MELOXICAM~GLENMARK GENERICS~15MG~A~077932~002~AB~Jul 19, 2
MELOXICAM~TABLET;ORAL~MELOXICAM~LUPIN PHARMS~7.5MG~A~077944~001~AB~Jul 19, 2006~
No~RX~LUPIN PHARMACEUTICALS INC
MELOXICAM~TABLET;ORAL~MELOXICAM~LUPIN PHARMS~15MG~A~077944~002~AB~Jul 19, 2006~N
MELOXICAM~TABLET;ORAL~MELOXICAM~MUTUAL PHARM~7.5MG~A~077935~001~~Jul 19, 2006~No
MELOXICAM~TABLET;ORAL~MELOXICAM~MUTUAL PHARM~15MG~A~077935~002~~Jul 19, 2006~No~
DISCN~MUTUAL PHARMACEUTICAL CO INC
MELOXICAM~TABLET;ORAL~MELOXICAM~MYLAN~7.5MG~A~077923~001~AB~Jul 19, 2006~No~RX~M
MELOXICAM~TABLET;ORAL~MELOXICAM~MYLAN~7.5MG~A~077934~001~~Jul 20, 2006~No~DISCN~
MELOXICAM~TABLET;ORAL~MELOXICAM~MYLAN~15MG~A~077923~002~AB~Jul 19, 2006~No~RX~MY
MELOXICAM~TABLET;ORAL~MELOXICAM~MYLAN~15MG~A~077934~002~~Jul 20, 2006~No~DISCN~M
MELOXICAM~TABLET;ORAL~MELOXICAM~PURACAP PHARM~7.5MG~A~077938~001~AB~Jul 19, 2006
~No~RX~PURACAP PHARMACEUTICAL LLC
MELOXICAM~TABLET;ORAL~MELOXICAM~PURACAP PHARM~15MG~A~077938~002~AB~Jul 19, 2006~
No~RX~PURACAP PHARMACEUTICAL LLC
MELOXICAM~TABLET;ORAL~MELOXICAM~ROXANE~7.5MG~A~077925~001~~Jul 19, 2006~No~DISCN
MELOXICAM~TABLET;ORAL~MELOXICAM~ROXANE~15MG~A~077925~002~~Jul 19, 2006~No~DISCN~
MELOXICAM~TABLET;ORAL~MELOXICAM~STRIDES PHARMA~7.5MG~A~077928~001~AB~May 13, 200
MELOXICAM~TABLET;ORAL~MELOXICAM~STRIDES PHARMA~15MG~A~077928~002~AB~May 13, 2009
~No~RX~STRIDES PHARMA GLOBAL PTE LTD
MELOXICAM~TABLET;ORAL~MELOXICAM~SUN PHARM INDS INC~7.5MG~A~077937~001~AB~Jul 19,
MELOXICAM~TABLET;ORAL~MELOXICAM~SUN PHARM INDS INC~15MG~A~077937~002~AB~Jul 19,
MELOXICAM~TABLET;ORAL~MELOXICAM~TARO~7.5MG~A~078102~001~AB~Nov 7, 2006~No~RX~TAR
MELOXICAM~TABLET;ORAL~MELOXICAM~TARO~15MG~A~078102~002~AB~Nov 7, 2006~No~RX~TARO
MELOXICAM~TABLET;ORAL~MELOXICAM~TEVA PHARMS~7.5MG~A~077936~001~AB~Jul 19, 2006~N
MELOXICAM~TABLET;ORAL~MELOXICAM~TEVA PHARMS~15MG~A~077936~002~AB~Jul 19, 2006~No

MELOXICAM~TABLET;ORAL~MELOXICAM~UNICHEM~7.5MG~A~077927~001~AB~Dec 20, 2006~No~RX
~UNICHEM LABORATORIES LTD
MELOXICAM~TABLET;ORAL~MELOXICAM~UNICHEM~15MG~A~077927~002~AB~Dec 20, 2006~No~RX~
UNICHEM LABORATORIES LTD
MELOXICAM~TABLET;ORAL~MELOXICAM~YABAO PHARM~7.5MG~A~077933~001~~Jul 19, 2006~No~
DISCN~YABAO PHARMACEUTICAL CO LTD BEIJING
MELOXICAM~TABLET;ORAL~MELOXICAM~YABAO PHARM~15MG~A~077933~002~~Jul 19, 2006~No~D
ISCN~YABAO PHARMACEUTICAL CO LTD BEIJING
MELOXICAM~TABLET;ORAL~MELOXICAM~ZYDUS PHARMS USA~7.5MG~A~077921~001~AB~Jul 19, 2
MELOXICAM~TABLET;ORAL~MELOXICAM~ZYDUS PHARMS USA~15MG~A~077921~002~AB~Jul 19, 20
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE~SUN PHARMA GLOBAL~5MG~A~090058~001
~~May 5, 2010~No~DISCN~SUN PHARMA GLOBAL FZE
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE~SUN PHARMA GLOBAL~10MG~A~090058~00
2~~May 5, 2010~No~DISCN~SUN PHARMA GLOBAL FZE
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE HYDROCHLORIDE~DR REDDYS LABS LTD~5
MG~A~090048~001~~Apr 14, 2010~No~DISCN~DR REDDYS LABORATORIES LTD
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE HYDROCHLORIDE~DR REDDYS LABS LTD~1
0MG~A~090048~002~~Apr 14, 2010~No~DISCN~DR REDDYS LABORATORIES LTD
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE HYDROCHLORIDE~MYLAN PHARMS INC~5MG
~A~079225~001~AB~Jan 30, 2015~No~RX~MYLAN PHARMACEUTICALS INC
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE HYDROCHLORIDE~MYLAN PHARMS INC~10M
G~A~079225~002~AB~Jan 30, 2015~No~RX~MYLAN PHARMACEUTICALS INC
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE HYDROCHLORIDE~ORCHID HLTHCARE~5MG~
A~090044~001~~Mar 12, 2012~No~DISCN~ORCHID HEALTHCARE
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE HYDROCHLORIDE~ORCHID HLTHCARE~10MG
~A~090044~002~~Mar 12, 2012~No~DISCN~ORCHID HEALTHCARE
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE HYDROCHLORIDE~TEVA PHARMS~5MG~A~09
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~MEMANTINE HYDROCHLORIDE~TEVA PHARMS~10MG~A~0
MENADIONE~TABLET;ORAL~MENADIONE~LILLY~5MG~N~002139~003~~Approved Prior to Jan 1,
ESTROGENS, ESTERIFIED~TABLET;ORAL~MENEST~MONARCH PHARMS~0.3MG~A~084951~001~~Appr
oved Prior to Jan 1, 1982~No~RX~MONARCH PHARMACEUTICALS INC
ESTROGENS, ESTERIFIED~TABLET;ORAL~MENEST~MONARCH PHARMS~0.625MG~A~084948~001~~Ap
proved Prior to Jan 1, 1982~No~RX~MONARCH PHARMACEUTICALS INC
ESTROGENS, ESTERIFIED~TABLET;ORAL~MENEST~MONARCH PHARMS~1.25MG~A~084950~001~~App
roved Prior to Jan 1, 1982~No~RX~MONARCH PHARMACEUTICALS INC
ESTROGENS, ESTERIFIED~TABLET;ORAL~MENEST~MONARCH PHARMS~2.5MG~A~084949~001~~Appr
oved Prior to Jan 1, 1982~Yes~RX~MONARCH PHARMACEUTICALS INC
CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED~TABLET;ORAL~MENRIUM 10-4~ROCHE~10MG;0.4M
G~N~014740~006~~Approved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED~TABLET;ORAL~MENRIUM 5-2~ROCHE~5MG;0.2MG~
N~014740~002~~Approved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED~TABLET;ORAL~MENRIUM 5-4~ROCHE~5MG;0.4MG~
N~014740~004~~Approved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~BARR~50MG~A~088639
~001~AA~Jul 2, 1984~No~RX~BARR LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~BARR~100MG~A~08864
0~001~AA~Sep 19, 1984~No~RX~BARR LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~DURAMED PHARMS BAR
R~50MG~A~040318~001~~Oct 5, 1999~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR L
ABORATORIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~DURAMED PHARMS BAR
R~100MG~A~040318~002~~Oct 5, 1999~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR
LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~EPIC PHARMA~50MG~A
~040331~001~AA~May 28, 1999~No~RX~EPIC PHARMA INC

MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~EPIC PHARMA~100MG~
A~040331~002~AA~May 28, 1999~No~RX~EPIC PHARMA INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~MALLINCKRODT~50MG~
A~040352~001~AA~Jun 13, 2000~No~RX~MALLINCKRODT INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~MALLINCKRODT~100MG
~A~040352~002~AA~Jun 13, 2000~No~RX~MALLINCKRODT INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~MIKART~50MG~A~0408
93~001~AA~Jun 24, 2009~No~RX~MIKART INC
93~002~~Jun 24, 2009~No~RX~MIKART INC
893~003~AA~Jun 24, 2009~No~RX~MIKART INC
893~004~~Jun 24, 2009~No~RX~MIKART INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~MUTUAL PHARM~50MG~
A~080448~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO IN
C
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~MUTUAL PHARM~100MG
~A~080448~002~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO I
NC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~ROXANE~50MG~A~0401
10~001~AA~Mar 12, 1997~No~RX~ROXANE LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~ROXANE~100MG~A~040
110~002~AA~Mar 12, 1997~No~RX~ROXANE LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~SUN PHARM INDS INC
~50MG~A~040446~001~AA~Aug 8, 2002~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~SUN PHARM INDS INC
~100MG~A~040446~002~AA~Aug 8, 2002~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~VINTAGE PHARMS~50M
G~A~040191~001~AA~Dec 17, 1998~No~RX~VINTAGE PHARMACEUTICALS INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~VINTAGE PHARMS~100
MG~A~040191~002~AA~Dec 17, 1998~No~RX~VINTAGE PHARMACEUTICALS INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~WATSON LABS~50MG~A
~040186~001~~Jun 30, 1997~No~DISCN~WATSON LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~WATSON LABS~100MG~
A~040186~002~~Jun 30, 1997~No~DISCN~WATSON LABORATORIES INC
MEPERIDINE HYDROCHLORIDE~TABLET;ORAL~MEPERIDINE HYDROCHLORIDE~WYETH AYERST~50MG~
A~080454~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
PHYTONADIONE~TABLET;ORAL~MEPHYTON~VALEANT PHARMS~5MG~N~010104~003~~Approved Prio
r to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA
MEPROBAMATE~TABLET;ORAL~MEPRIAM~TEVA~400MG~N~016069~001~~Approved Prior to Jan 1
, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
ASPIRIN; MEPROBAMATE~TABLET;ORAL~MEPRO-ASPIRIN~SANDOZ~325MG;200MG~A~089127~001~~
Mar 2, 1987~No~DISCN~SANDOZ INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~ALEMBIC PHARMS LTD~200MG~A~090122~001~AA~Feb
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~ALEMBIC PHARMS LTD~400MG~A~090122~002~AA~Feb
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~BARR~600MG~A~084230~001~~Approved Prior to J
an 1, 1982~No~DISCN~BARR LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~ELKINS SINN~200MG~N~015426~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~ELKINS SINN~400MG~N~015426~001~~Approved Pri
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~HEATHER~400MG~N~016928~003~~Approved Prior t
o Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~HEATHER~600MG~A~084329~001~~Approved Prior t
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~IMPAX LABS~200MG~N~014322~002~~Approved Prio
r to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC

MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~IMPAX LABS~400MG~N~014322~001~~Approved Prio
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~INVAGEN PHARMS~200MG~A~040797~001~AA~Feb 27,
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~INVAGEN PHARMS~400MG~A~040797~002~AA~Feb 27,
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~IVAX SUB TEVA PHARMS~200MG~N~015438~001~~App
roved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUT
ICALS USA
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~IVAX SUB TEVA PHARMS~400MG~N~015438~002~~App
ICALS USA
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~IVAX SUB TEVA PHARMS~600MG~A~084181~001~~App
ICALS USA
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~IVC INDS~400MG~A~084153~001~~Approved Prior
to Jan 1, 1982~No~DISCN~IVC INDUSTRIES INC DBA INVERNESS MEDICAL NUTRITIONALS GR
OUP
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~LANNETT~200MG~N~014882~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~LANNETT CO INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~LANNETT~400MG~N~014882~001~~Approved Prior t
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~LEDERLE~400MG~A~086299~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~LEE KM~400MG~A~089538~001~~Nov 25, 1987~No~D
ISCN~KM LEE LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~MALLARD~400MG~N~015072~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~MALLARD INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~MK LABS~200MG~N~014368~004~~Approved Prior t
o Jan 1, 1982~No~DISCN~MK LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~MK LABS~400MG~N~014368~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~MK LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~MUTUAL PHARM~200MG~A~080699~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~MUTUAL PHARM~400MG~A~080699~002~~Approved Pr
ior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~MYLAN~400MG~A~083618~001~~Approved Prior to
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~NEXGEN PHARMA INC~200MG~A~084220~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~NEXGEN PHARMA INC~400MG~A~084589~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~PARKE DAVIS~200MG~A~084744~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~PARKE DAVIS~400MG~A~084744~002~~Approved Pri
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~PERRIGO~200MG~A~084546~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~L PERRIGO CO
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~PERRIGO~400MG~A~084547~001~~Approved Prior t
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~PHARMAVITE~400MG~A~084438~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~PHARMAVITE PHARMACEUTICALS
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~PUREPAC PHARM~200MG~A~084804~001~~Approved P
rior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~PUREPAC PHARM~400MG~A~084804~002~~Approved P
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~PVT FORM~400MG~N~014601~001~~Approved Prior
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~ROXANE~600MG~A~084332~001~~Approved Prior to

MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~SANDOZ~200MG~N~014547~002~~Approved Prior to
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~SANDOZ~400MG~A~080655~001~~Approved Prior to
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~SANDOZ~400MG~N~014547~001~~Approved Prior to
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~SCHERER LABS~400MG~A~083343~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~SCHERER LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~SOLVAY~200MG~A~084435~001~~Approved Prior to
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~STANLABS PHARM~200MG~N~014474~002~~Approved
Prior to Jan 1, 1982~No~DISCN~STANLABS PHARMACEUTICAL CO SUB SIMPAK CORP
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~STANLABS PHARM~400MG~N~014474~004~~Approved
Prior to Jan 1, 1982~No~DISCN~STANLABS PHARMACEUTICAL CO SUB SIMPAK CORP
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~TABLICAPS~400MG~A~083494~001~~Approved Prior
to Jan 1, 1982~No~DISCN~TABLICAPS INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~TARO~200MG~A~200998~001~~May 23, 2011~No~DIS
CN~TARO PHARMACEUTICAL INDUSTRIES LTD
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~TARO~400MG~A~200998~002~~May 23, 2011~No~DIS
CN~TARO PHARMACEUTICAL INDUSTRIES LTD
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~USL PHARMA~200MG~A~087825~001~~Mar 18, 1982~
No~DISCN~USL PHARMA INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~USL PHARMA~400MG~A~087826~001~~Mar 18, 1982~
No~DISCN~USL PHARMA INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~VALEANT PHARM INTL~200MG~N~015139~006~~Appro
ved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~VALEANT PHARM INTL~400MG~N~015139~005~~Appro
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~VANGARD~400MG~A~088011~001~~Jul 14, 1982~No~
DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~WATSON LABS~200MG~A~083304~001~AA~Approved P
rior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~WATSON LABS~200MG~A~085720~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~WATSON LABS~400MG~A~083308~001~AA~Approved P
rior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~WEST WARD~200MG~N~015417~003~~Approved Prior
to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~WEST WARD~400MG~N~015417~002~~Approved Prior
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~WHITEWORTH TOWN PLSN~200MG~A~083830~001~~App
roved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
MEPROBAMATE~TABLET;ORAL~MEPROBAMATE~WHITEWORTH TOWN PLSN~400MG~A~083442~001~~App
ASPIRIN; MEPROBAMATE~TABLET;ORAL~MEPROBAMATE AND ASPIRIN~PAR PHARM~325MG;200MG~A
~089126~001~~Aug 19, 1986~No~DISCN~PAR PHARMACEUTICAL INC
ATOVAQUONE~TABLET;ORAL~MEPRON~GLAXOSMITHKLINE LLC~250MG **Federal Register deter
easons**~N~020259~001~~Nov 25, 1992~No~DISCN~GLAXOSMITHKLINE LLC
MERCAPTOPURINE~TABLET;ORAL~MERCAPTOPURINE~MYLAN~50MG~A~040594~001~AB~Jul 1, 2005
MERCAPTOPURINE~TABLET;ORAL~MERCAPTOPURINE~PROMETHEUS LABS~50MG~A~040461~001~AB~F
eb 11, 2004~No~RX~PROMETHEUS LABORATORIES INC
MERCAPTOPURINE~TABLET;ORAL~MERCAPTOPURINE~ROXANE~50MG~A~040528~001~AB~Feb 13, 20
MEPHENYTOIN~TABLET;ORAL~MESANTOIN~NOVARTIS~100MG **Federal Register determinatio
n that product was not discontinued or withdrawn for safety or efficacy reasons*
*~N~006008~001~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS
CORP
MESNA~TABLET;ORAL~MESNEX~BAXTER HLTHCARE~400MG~N~020855~001~~Mar 21, 2002~Yes~RX
~BAXTER HEALTHCARE CORP
PYRIDOSTIGMINE BROMIDE~TABLET;ORAL~MESTINON~VALEANT PHARMS LLC~60MG~N~009829~002
~AB~Approved Prior to Jan 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA L
LC
GLIPIZIDE; METFORMIN HYDROCHLORIDE~TABLET;ORAL~METAGLIP~BRISTOL MYERS SQUIBB~2.5
MG;250MG~N~021460~001~~Oct 21, 2002~No~DISCN~BRISTOL MYERS SQUIBB CO
GLIPIZIDE; METFORMIN HYDROCHLORIDE~TABLET;ORAL~METAGLIP~BRISTOL MYERS SQUIBB~2.5
MG;500MG~N~021460~002~~Oct 21, 2002~No~DISCN~BRISTOL MYERS SQUIBB CO
GLIPIZIDE; METFORMIN HYDROCHLORIDE~TABLET;ORAL~METAGLIP~BRISTOL MYERS SQUIBB~5MG
;500MG~N~021460~003~~Oct 21, 2002~No~DISCN~BRISTOL MYERS SQUIBB CO
TRICHLORMETHIAZIDE~TABLET;ORAL~METAHYDRIN~SANOFI AVENTIS US~2MG~N~012594~001~~Ju
n 16, 1988~No~DISCN~SANOFI AVENTIS US LLC
TRICHLORMETHIAZIDE~TABLET;ORAL~METAHYDRIN~SANOFI AVENTIS US~4MG~N~012594~002~~Ju
n 16, 1988~No~DISCN~SANOFI AVENTIS US LLC
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~AM THERAP~10MG~A~07205
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~AM THERAP~20MG~A~07205
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~PAR PHARM~10MG~A~07202
4~001~~Jun 28, 1988~No~RX~PAR PHARMACEUTICAL INC
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~PAR PHARM~20MG~A~07202
5~001~~Jun 28, 1988~Yes~RX~PAR PHARMACEUTICAL INC
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~TEVA~10MG~A~072519~001
~~Mar 30, 1990~No~DISCN~TEVA PHARMACEUTICALS USA INC
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~TEVA~20MG~A~072520~001
~~Mar 30, 1990~No~DISCN~TEVA PHARMACEUTICALS USA INC
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~USL PHARMA~10MG~A~0710
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~USL PHARMA~20MG~A~0710
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~WATSON LABS~10MG~A~073
METAPROTERENOL SULFATE~TABLET;ORAL~METAPROTERENOL SULFATE~WATSON LABS~20MG~A~072
RESERPINE; TRICHLORMETHIAZIDE~TABLET;ORAL~METATENSIN #2~SANOFI AVENTIS US~0.1MG;
2MG~N~012972~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
RESERPINE; TRICHLORMETHIAZIDE~TABLET;ORAL~METATENSIN #4~SANOFI AVENTIS US~0.1MG;
METAXALONE~TABLET;ORAL~METAXALONE~AMNEAL PHARMS~800MG~A~203399~001~AB~Jun 21, 20
METAXALONE~TABLET;ORAL~METAXALONE~COREPHARMA~400MG~A~040486~001~~Feb 27, 2015~No
~RX~COREPHARMA LLC
METAXALONE~TABLET;ORAL~METAXALONE~SANDOZ~800MG~A~040445~001~AB~Mar 31, 2010~No~R
X~SANDOZ INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ALKEM~1GM~A~091184~0
03~AB~Nov 1, 2010~No~RX~ALKEM LABORATORIES LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ALKEM~500MG~A~091184
~001~AB~Nov 1, 2010~No~RX~ALKEM LABORATORIES LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ALKEM~850MG~A~091184
~002~AB~Nov 1, 2010~No~RX~ALKEM LABORATORIES LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~AMNEAL PHARMS NY~1GM
~A~077880~003~AB~Jun 5, 2006~No~RX~AMNEAL PHARMACEUTICALS NY LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~AMNEAL PHARMS NY~500
MG~A~077880~001~AB~Jun 5, 2006~No~RX~AMNEAL PHARMACEUTICALS NY LLC

METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~AMNEAL PHARMS NY~850
MG~A~077880~002~AB~Jun 5, 2006~No~RX~AMNEAL PHARMACEUTICALS NY LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~APOTEX~1GM~A~075984~
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~APOTEX~1GM~A~090666~
003~AB~Dec 7, 2011~No~RX~APOTEX INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~APOTEX~500MG~A~07598
4~001~AB~Apr 23, 2002~No~RX~APOTEX INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ATLAS PHARMS LLC~1GM
~A~076033~003~AB~Jan 24, 2002~No~RX~ATLAS PHARMACEUTICALS LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ATLAS PHARMS LLC~500
MG~A~076033~001~AB~Jan 24, 2002~No~RX~ATLAS PHARMACEUTICALS LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ATLAS PHARMS LLC~850
MG~A~076033~002~AB~Jan 24, 2002~No~RX~ATLAS PHARMACEUTICALS LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~AUROBINDO~1GM~A~0770
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~AUROBINDO~500MG~A~07
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~AUROBINDO~850MG~A~07
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~BARR~1GM~A~075971~00
3~~Jan 25, 2002~No~DISCN~BARR LABORATORIES INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~BARR~500MG~A~075971~
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~BARR~850MG~A~075971~
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~CHARTWELL LIFE SCI~1
GM~A~075972~003~AB~Jan 24, 2002~No~RX~CHARTWELL LIFE SCIENCE LLC
00MG~A~075972~001~AB~Jan 24, 2002~No~RX~CHARTWELL LIFE SCIENCE LLC
25MG~A~075972~005~~Jan 24, 2002~No~RX~CHARTWELL LIFE SCIENCE LLC
50MG~A~075972~004~~Jan 24, 2002~No~RX~CHARTWELL LIFE SCIENCE LLC
50MG~A~075972~002~AB~Jan 24, 2002~No~RX~CHARTWELL LIFE SCIENCE LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~DR REDDYS LABS INC~1
GM~A~077787~003~AB~Aug 23, 2006~No~RX~DR REDDYS LABORATORIES INC
00MG~A~077787~001~AB~Aug 23, 2006~No~RX~DR REDDYS LABORATORIES INC
50MG~A~077787~002~AB~Aug 23, 2006~No~RX~DR REDDYS LABORATORIES INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~GLENMARK GENERICS~1G
M~A~078170~003~AB~May 23, 2008~No~RX~GLENMARK GENERICS LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~GLENMARK GENERICS~50
0MG~A~078170~001~AB~May 23, 2008~No~RX~GLENMARK GENERICS LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~GLENMARK GENERICS~85
0MG~A~078170~002~AB~May 23, 2008~No~RX~GLENMARK GENERICS LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~GRANULES INDIA~1GM~A
~090564~003~AB~Apr 22, 2010~No~RX~GRANULES INDIA LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~GRANULES INDIA~500MG
~A~090564~001~AB~Apr 22, 2010~No~RX~GRANULES INDIA LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~GRANULES INDIA~850MG
~A~090564~002~AB~Apr 22, 2010~No~RX~GRANULES INDIA LTD

METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~INDICUS PHARMA~1GM~A
~079148~003~AB~Nov 25, 2008~No~RX~INDICUS PHARMA LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~INDICUS PHARMA~500MG
~A~079148~001~AB~Nov 25, 2008~No~RX~INDICUS PHARMA LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~INDICUS PHARMA~850MG
~A~079148~002~AB~Nov 25, 2008~No~RX~INDICUS PHARMA LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~IPCA LABS LTD~1GM~A~
078422~003~~Aug 6, 2007~No~DISCN~IPCA LABORATORIES LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~IPCA LABS LTD~500MG~
A~078422~001~~Aug 6, 2007~No~DISCN~IPCA LABORATORIES LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~IPCA LABS LTD~850MG~
A~078422~002~~Aug 6, 2007~No~DISCN~IPCA LABORATORIES LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~IVAX SUB TEVA PHARMS
~1GM~A~075975~003~~Jan 24, 2002~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
~500MG~A~075975~001~~Jan 24, 2002~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHA
RMACEUTICALS USA
RMACEUTICALS USA
RMACEUTICALS USA
RMACEUTICALS USA
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MARKSANS PHARMA~1GM~
A~090888~003~AB~Mar 12, 2012~No~RX~MARKSANS PHARMA LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MARKSANS PHARMA~500M
G~A~090888~001~AB~Mar 12, 2012~No~RX~MARKSANS PHARMA LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MARKSANS PHARMA~850M
G~A~090888~002~AB~Mar 12, 2012~No~RX~MARKSANS PHARMA LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MUTUAL PHARMA~1GM~A~
076038~003~AB~Feb 21, 2002~No~RX~MUTUAL PHARMACAL CO
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MUTUAL PHARMA~500MG~
A~076038~001~AB~Feb 21, 2002~No~RX~MUTUAL PHARMACAL CO
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MUTUAL PHARMA~850MG~
A~076038~002~AB~Feb 21, 2002~No~RX~MUTUAL PHARMACAL CO
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MYLAN~1GM~A~075973~0
03~AB~Jan 25, 2002~No~RX~MYLAN PHARMACEUTICALS INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MYLAN~1GM~A~075976~0
03~AB~Jan 24, 2002~No~RX~MYLAN PHARMACEUTICALS INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MYLAN~500MG~A~075973
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MYLAN PHARMS INC~1GM
~A~075969~003~AB~Jan 29, 2002~No~RX~MYLAN PHARMACEUTICALS INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MYLAN PHARMS INC~500
MG~A~075969~001~AB~Jan 29, 2002~No~RX~MYLAN PHARMACEUTICALS INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~MYLAN PHARMS INC~850
MG~A~075969~002~AB~Jan 29, 2002~No~RX~MYLAN PHARMACEUTICALS INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~PROVIDENT PHARM~1GM~
A~077853~003~AB~Jul 28, 2006~No~RX~PROVIDENT PHARMACEUTICAL INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~PROVIDENT PHARM~500M

G~A~077853~001~AB~Jul 28, 2006~No~RX~PROVIDENT PHARMACEUTICAL INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~PROVIDENT PHARM~850M
G~A~077853~002~AB~Jul 28, 2006~No~RX~PROVIDENT PHARMACEUTICAL INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~SANDOZ~1GM~A~075965~
003~AB~Jan 25, 2002~No~RX~SANDOZ INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~SANDOZ~1GM~A~075985~
003~AB~Jan 25, 2002~No~RX~SANDOZ INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~SANDOZ~500MG~A~07596
5~001~AB~Jan 25, 2002~No~RX~SANDOZ INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~SCIEGEN PHARMS INC~5
00MG~A~203769~001~AB~Sep 11, 2013~No~RX~SCIEGEN PHARMACEUTICALS INC
50MG~A~203769~002~AB~Sep 11, 2013~No~RX~SCIEGEN PHARMACEUTICALS INC
GM~A~203769~003~AB~Sep 11, 2013~No~RX~SCIEGEN PHARMACEUTICALS INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~SUN PHARM INDS INC~1
GM~A~075967~003~AB~Jan 29, 2002~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
00MG~A~075967~001~AB~Jan 29, 2002~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
50MG~A~075967~002~AB~Jan 29, 2002~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~TEVA~1GM~A~075978~00
3~AB~Nov 5, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~TEVA~1GM~A~076328~00
3~~Dec 16, 2002~No~DISCN~TEVA PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~TEVA~500MG~A~075978~
001~AB~Jan 25, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
002~AB~Jan 25, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~TORRENT PHARMS~1GM~A
~077711~003~AB~Jan 24, 2007~No~RX~TORRENT PHARMACEUTICALS LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~TORRENT PHARMS~500MG
~A~077711~001~AB~Jan 24, 2007~No~RX~TORRENT PHARMACEUTICALS LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~TORRENT PHARMS~850MG
~A~077711~002~AB~Jan 24, 2007~No~RX~TORRENT PHARMACEUTICALS LTD
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~WATSON LABS~1GM~A~07
5979~003~~Jan 24, 2002~No~DISCN~WATSON LABORATORIES
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~WATSON LABS~500MG~A~
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~WATSON LABS~850MG~A~
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~WATSON LABS FLORIDA~
1GM~A~075961~003~AB~Jan 25, 2002~No~RX~WATSON LABORATORIES INC FLORIDA
500MG~A~075961~001~AB~Jan 25, 2002~No~RX~WATSON LABORATORIES INC FLORIDA
850MG~A~075961~002~AB~Jan 25, 2002~No~RX~WATSON LABORATORIES INC FLORIDA
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ZYDUS HLTHCARE~1GM~A
~203686~003~AB~Aug 28, 2014~No~RX~ZYDUS HEALTHCARE USA LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ZYDUS HLTHCARE~500MG

~A~203686~001~AB~Aug 28, 2014~No~RX~ZYDUS HEALTHCARE USA LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ZYDUS HLTHCARE~850MG
~A~203686~002~AB~Aug 28, 2014~No~RX~ZYDUS HEALTHCARE USA LLC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ZYDUS PHARMS USA~1GM
~A~077064~003~AB~Apr 18, 2005~No~RX~ZYDUS PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ZYDUS PHARMS USA~500
MG~A~077064~001~AB~Apr 18, 2005~No~RX~ZYDUS PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE~TABLET;ORAL~METFORMIN HYDROCHLORIDE~ZYDUS PHARMS USA~850
MG~A~077064~002~AB~Apr 18, 2005~No~RX~ZYDUS PHARMACEUTICALS USA INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADONE HYDROCHLORIDE~MALLINCKRODT~5MG~A~0
40517~001~AA~Apr 27, 2004~No~RX~MALLINCKRODT INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADONE HYDROCHLORIDE~MALLINCKRODT~10MG~A~
040517~002~AA~Apr 27, 2004~No~RX~MALLINCKRODT INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADONE HYDROCHLORIDE~ROXANE~5MG~A~088108~
001~~Mar 8, 1983~No~DISCN~ROXANE LABORATORIES INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADONE HYDROCHLORIDE~ROXANE~10MG~A~088109
~001~~Mar 8, 1983~No~DISCN~ROXANE LABORATORIES INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADONE HYDROCHLORIDE~ROXANE~40MG~A~074081
~001~~Apr 28, 1995~No~DISCN~ROXANE LABORATORIES INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADONE HYDROCHLORIDE~SANDOZ~5MG~A~040241~
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADONE HYDROCHLORIDE~SANDOZ~10MG~A~040241
~002~AA~May 29, 1998~No~RX~SANDOZ INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADONE HYDROCHLORIDE~THE PHARMANETWORK~10
MG~A~090635~001~AA~Nov 25, 2009~No~RX~THE PHARMANETWORK LLC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADOSE~MALLINCKRODT~5MG~A~040050~001~AA~A
pr 15, 1993~No~RX~MALLINCKRODT CHEMICAL INC
METHADONE HYDROCHLORIDE~TABLET;ORAL~METHADOSE~MALLINCKRODT~10MG~A~040050~002~AA~
Apr 15, 1993~No~RX~MALLINCKRODT CHEMICAL INC
METHAMPHETAMINE HYDROCHLORIDE~TABLET;ORAL~METHAMPEX~TEVA~10MG~A~083889~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
METHAMPHETAMINE HYDROCHLORIDE~TABLET;ORAL~METHAMPHETAMINE HYDROCHLORIDE~ABLE~5MG
~A~040529~001~~Feb 25, 2004~No~DISCN~ABLE LABORATORIES INC
METHAMPHETAMINE HYDROCHLORIDE~TABLET;ORAL~METHAMPHETAMINE HYDROCHLORIDE~COASTAL
PHARMS~5MG~A~091189~001~AA~Apr 21, 2010~No~RX~COASTAL PHARMACEUTICALS
METHAMPHETAMINE HYDROCHLORIDE~TABLET;ORAL~METHAMPHETAMINE HYDROCHLORIDE~REXAR~5M
G~A~084931~001~~Approved Prior to Jan 1, 1982~No~DISCN~REXAR PHARMACAL
METHAMPHETAMINE HYDROCHLORIDE~TABLET;ORAL~METHAMPHETAMINE HYDROCHLORIDE~REXAR~10
MG~A~084931~002~~Approved Prior to Jan 1, 1982~No~DISCN~REXAR PHARMACAL
METHAMPHETAMINE HYDROCHLORIDE~TABLET;ORAL~METHAMPHETAMINE HYDROCHLORIDE~TEVA~5MG
~A~086359~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA I
NC
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~ANI PHARMS INC~25MG~A~040001~001~AB~Jun
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~ANI PHARMS INC~50MG~A~040001~002~AB~Jun
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~APPLIED ANAL~25MG~A~040011~001~~Jul 17,
1997~No~DISCN~APPLIED ANALYTICAL INDUSTRIES
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~APPLIED ANAL~50MG~A~040011~002~~Jul 17,
1997~No~DISCN~APPLIED ANALYTICAL INDUSTRIES
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~MIKART~25MG~A~040062~001~AB~Jan 27, 1994
~No~RX~MIKART INC
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~MIKART~50MG~A~040062~002~AB~Jan 27, 1994
~Yes~RX~MIKART INC
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~SANDOZ~25MG~A~040036~001~AB~Jun 30, 1993
~No~RX~SANDOZ INC
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~SANDOZ~25MG~A~040102~001~~Aug 28, 1996~N
o~DISCN~SANDOZ INC
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~SANDOZ~50MG~A~040036~002~AB~Jun 30, 1993
~No~RX~SANDOZ INC
METHAZOLAMIDE~TABLET;ORAL~METHAZOLAMIDE~SANDOZ~50MG~A~040102~002~~Aug 28, 1996~N
o~DISCN~SANDOZ INC
METHENAMINE HIPPURATE~TABLET;ORAL~METHENAMINE HIPPURATE~COREPHARMA~1GM~A~076411~
001~AB~Jun 20, 2003~No~RX~COREPHARMA LLC
METHYLERGONOVINE MALEATE~TABLET;ORAL~METHERGINE~EDISON THERAPS LLC~0.2MG~N~00603
5~003~AB~Approved Prior to Jan 1, 1982~Yes~RX~EDISON THERAPEUTICS LLC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~CEDAR PHARMS~5MG~A~040547~001~AB~Feb 18, 200
5~No~RX~CEDAR PHARMACEUTICALS LLC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~CEDAR PHARMS~10MG~A~040547~002~AB~Feb 18, 20
05~No~RX~CEDAR PHARMACEUTICALS LLC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~CEDAR PHARMS~15MG~A~040619~003~~Jul 12, 2005
~No~DISCN~CEDAR PHARMACEUTICALS LLC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~CEDAR PHARMS~20MG~A~040547~004~~Feb 18, 2005
~No~DISCN~CEDAR PHARMACEUTICALS LLC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~EMCURE PHARMS USA~5MG~A~040734~001~AB~Dec 14
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~EMCURE PHARMS USA~10MG~A~040734~002~AB~Dec 1
4, 2007~No~RX~EMCURE PHARMACEUTICALS USA INC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~MYLAN~5MG~A~040350~001~AB~Mar 29, 2000~No~RX
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~MYLAN~10MG~A~040350~002~AB~Mar 29, 2000~Yes~
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~MYLAN~20MG~A~040350~003~~Jun 7, 2001~No~DISC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~SANDOZ~5MG~A~040411~001~AB~Mar 27, 2001~No~R
X~SANDOZ INC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~SANDOZ~10MG~A~040411~002~AB~Mar 27, 2001~No~
RX~SANDOZ INC
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~SUN PHARM INDS INC~5MG~A~040870~001~AB~Sep 2
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~SUN PHARM INDS INC~10MG~A~040870~002~AB~Sep
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~VINTAGE PHARMS~5MG~A~202068~001~AB~Mar 7, 20
METHIMAZOLE~TABLET;ORAL~METHIMAZOLE~VINTAGE PHARMS~10MG~A~202068~002~AB~Mar 7, 2
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~ABLE~500MG~A~040413~001~~Mar 17, 2003~No
~DISCN~ABLE LABORATORIES INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~ABLE~750MG~A~040413~002~~Mar 17, 2003~No
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~AM THERAP~500MG~A~089417~001~~Feb 11, 19
87~No~DISCN~AMERICAN THERAPEUTICS INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~AM THERAP~750MG~A~089418~001~~Feb 11, 19
87~No~DISCN~AMERICAN THERAPEUTICS INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~ASCOT~500MG~A~087660~001~~Oct 27, 1982~N
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~ASCOT~750MG~A~087661~001~~Oct 27, 1982~N
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~AUSTARPHARMA LLC~500MG~A~200958~001~AA~O
ct 21, 2011~No~RX~AUSTARPHARMA LLC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~AUSTARPHARMA LLC~750MG~A~200958~002~AA~O
ct 21, 2011~No~RX~AUSTARPHARMA LLC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~CLONMEL HLTHCARE~500MG~A~085961~001~~App
roved Prior to Jan 1, 1982~No~DISCN~CLONMEL HEALTHCARE LTD
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~CLONMEL HLTHCARE~750MG~A~085963~001~~App
roved Prior to Jan 1, 1982~No~DISCN~CLONMEL HEALTHCARE LTD
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~HEATHER~500MG~A~084675~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~HEATHER~750MG~A~084924~001~~Approved Pri

METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~HETERO LABS LTD III~500MG~A~090200~001~A
A~Nov 6, 2009~No~RX~HETERO LABS LTD UNIT III
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~HETERO LABS LTD III~750MG~A~090200~002~A
A~Nov 6, 2009~No~RX~HETERO LABS LTD UNIT III
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~HIKMA INTL PHARMS~500MG~A~085159~001~AA~
Approved Prior to Jan 1, 1982~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~HIKMA INTL PHARMS~750MG~A~085123~001~AA~
Approved Prior to Jan 1, 1982~No~RX~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~IMPAX LABS~500MG~A~084927~001~~Approved
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~IMPAX LABS~750MG~A~084928~001~~Approved
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~INWOOD LABS~500MG~A~085137~001~~Approved
Prior to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES I
NC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~IVAX SUB TEVA PHARMS~500MG~A~084648~001~
~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMA
CEUTICALS USA
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~IVAX SUB TEVA PHARMS~750MG~A~084649~001~
CEUTICALS USA
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~KV PHARM~500MG~A~085660~001~~Approved Pr
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~KV PHARM~750MG~A~085658~001~~Approved Pr
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~LANNETT HOLDINGS INC~500MG~A~084756~002~
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~LANNETT HOLDINGS INC~750MG~A~084756~001~
AA~Approved Prior to Jan 1, 1982~No~RX~LANNETT HOLDINGS INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~MUTUAL PHARM~500MG~A~084488~001~~Approve
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~MUTUAL PHARM~750MG~A~084486~001~~Approve
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~MYLAN~500MG~A~084259~001~~Approved Prior
to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~MYLAN~750MG~A~084323~001~~Approved Prior
to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~NYLOS~750MG~A~085033~001~~Approved Prior
to Jan 1, 1982~No~DISCN~NYLOS TRADING CO INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~PIONEER PHARMS~500MG~A~088731~001~~Dec 1
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~PIONEER PHARMS~750MG~A~089082~001~~Dec 1
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~PRINSTON INC~500MG~A~086989~001~AA~Appro
ved Prior to Jan 1, 1982~No~RX~PRINSTON PHARMACEUTICAL INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~PRINSTON INC~750MG~A~086988~001~AA~Appro
ved Prior to Jan 1, 1982~No~RX~PRINSTON PHARMACEUTICAL INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~PURACAP PHARM~500MG~A~084231~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~PURACAP PHARMACEUTICAL LLC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~PURACAP PHARM~750MG~A~084471~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~PURACAP PHARMACEUTICAL LLC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~PUREPAC PHARM~500MG~A~085718~001~~Approv
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~PUREPAC PHARM~750MG~A~085718~002~~Approv
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~ROXANE~500MG~A~088646~001~~Feb 29, 1984~
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~ROXANE~750MG~A~088647~001~~Feb 29, 1984~
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~SANDOZ~500MG~A~084616~001~AA~Approved Pr
ior to Jan 1, 1982~No~RX~SANDOZ INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~SANDOZ~500MG~A~087283~001~~Approved Prio
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~SANDOZ~750MG~A~084615~001~AA~Approved Pr
ior to Jan 1, 1982~No~RX~SANDOZ INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~SANDOZ~750MG~A~087282~001~~Approved Prio
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~SOLVAY~500MG~A~084448~001~~Approved Prio
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~SOLVAY~750MG~A~084449~001~~Approved Prio
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~SUPERPHARM~500MG~A~087589~001~~Jan 22, 1
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~SUPERPHARM~750MG~A~087590~001~~Jan 22, 1
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~TABLICAPS~500MG~A~084846~001~~Approved P
rior to Jan 1, 1982~No~DISCN~TABLICAPS INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~UPSHER SMITH~500MG~A~087453~001~~Approve
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~UPSHER SMITH~750MG~A~087454~001~~Approve
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~VINTAGE PHARMS~500MG~A~040489~001~AA~Jan
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~VINTAGE PHARMS~750MG~A~040489~002~AA~Jan
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~WATSON LABS~500MG~A~083605~001~~Approved
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~WATSON LABS~500MG~A~084277~001~AA~Approv
ed Prior to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL~WATSON LABS~750MG~A~084276~002~AA~Approv
ASPIRIN; METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL AND ASPIRIN~IVAX SUB TEVA PHARM
S~325MG;400MG~A~087211~001~~Dec 22, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB T
ASPIRIN; METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL AND ASPIRIN~MCNEIL~325MG;400MG~
A~089193~001~~Feb 12, 1986~No~DISCN~MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
ASPIRIN; METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL AND ASPIRIN~PAR PHARM~325MG;400
MG~A~089657~001~~Nov 4, 1988~No~DISCN~PAR PHARMACEUTICAL INC
ASPIRIN; METHOCARBAMOL~TABLET;ORAL~METHOCARBAMOL AND ASPIRIN~STEVENS J~325MG;400
MG~A~081145~001~~Jan 31, 1995~Yes~RX~JEROME STEVENS PHARMACEUTICALS INC
METHOTREXATE SODIUM~TABLET;ORAL~METHOTREXATE SODIUM~BARR~EQ 2.5MG BASE~A~081099~
001~AB~Oct 15, 1990~No~RX~BARR LABORATORIES INC
METHOTREXATE SODIUM~TABLET;ORAL~METHOTREXATE SODIUM~DAVA PHARMS INC~EQ 2.5MG BAS
E~N~008085~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~DAVA PHARMACEUTICALS INC
METHOTREXATE SODIUM~TABLET;ORAL~METHOTREXATE SODIUM~DURAMED PHARMS BARR~EQ 2.5MG
BASE~A~040233~001~~Jun 17, 1999~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR L
ABORATORIES INC
METHOTREXATE SODIUM~TABLET;ORAL~METHOTREXATE SODIUM~MYLAN~EQ 2.5MG BASE~A~081235
~001~AB~May 15, 1992~No~RX~MYLAN PHARMACEUTICALS INC
METHOTREXATE SODIUM~TABLET;ORAL~METHOTREXATE SODIUM~ROXANE~EQ 2.5MG BASE~A~04005
4~001~AB~Aug 1, 1994~No~RX~ROXANE LABORATORIES INC
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~METHSCOPOLAMINE BROMIDE~BAYSHORE PHARMS LLC~
2.5MG~A~200602~001~AA~Sep 24, 2012~No~RX~BAYSHORE PHARMACEUTICALS LLC
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~METHSCOPOLAMINE BROMIDE~BAYSHORE PHARMS LLC~

5MG~A~200602~002~AA~Sep 24, 2012~No~RX~BAYSHORE PHARMACEUTICALS LLC
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~METHSCOPOLAMINE BROMIDE~BRECKENRIDGE PHARM~2
.5MG~A~040642~001~AA~Dec 6, 2011~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~METHSCOPOLAMINE BROMIDE~BRECKENRIDGE PHARM~5
MG~A~040642~002~AA~Dec 6, 2011~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~METHSCOPOLAMINE BROMIDE~PVT FORM~2.5MG~A~080
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~METHSCOPOLAMINE BROMIDE~VINTAGE PHARMS~2.5MG
~A~040624~001~AA~Dec 28, 2006~No~RX~VINTAGE PHARMACEUTICALS
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~METHSCOPOLAMINE BROMIDE~VINTAGE PHARMS~5MG~A
~040624~002~AA~Dec 28, 2006~No~RX~VINTAGE PHARMACEUTICALS
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~IVAX PHARMS~2.5MG~A~087913~001~~Ju
n 3, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~IVAX PHARMS~5MG~A~087786~001~~May
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~MYLAN~2.5MG~A~087671~001~~Aug 17,
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~MYLAN PHARMS INC~5MG~A~087672~001~
~Aug 17, 1982~Yes~RX~MYLAN PHARMACEUTICALS INC
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~PAR PHARM~2.5MG~A~089135~001~~Feb
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~PAR PHARM~5MG~A~089136~001~~Feb 12
, 1986~No~DISCN~PAR PHARMACEUTICAL INC
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~SANDOZ~2.5MG~A~089835~001~~Aug 18,
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~SANDOZ~5MG~A~089837~001~~Aug 18, 1
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~USL PHARMA~5MG~A~088745~001~~Mar 2
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~WATSON LABS~2.5MG~A~085487~001~~Ma
r 11, 1982~No~DISCN~WATSON LABORATORIES INC
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~WATSON LABS~2.5MG~A~088750~001~~Se
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~WATSON LABS~5MG~A~085476~001~~Mar
METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE~WATSON LABS~5MG~A~088724~001~~Sep
DESERPIDINE; METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE AND DESERPIDINE~WATSO
N LABS~0.25MG;5MG~A~088486~001~~Aug 10, 1984~No~DISCN~WATSON LABORATORIES INC
DESERPIDINE; METHYCLOTHIAZIDE~TABLET;ORAL~METHYCLOTHIAZIDE AND DESERPIDINE~WATSO
N LABS~0.5MG;5MG~A~088452~001~~Aug 10, 1984~No~DISCN~WATSON LABORATORIES INC
METHYLDOPA~TABLET;ORAL~METHYLDOPA~ACCORD HLTHCARE~125MG~A~070070~003~~Oct 15, 19
85~No~DISCN~ACCORD HEALTHCARE INC
METHYLDOPA~TABLET;ORAL~METHYLDOPA~ACCORD HLTHCARE~250MG~A~070084~001~AB~Oct 15,
METHYLDOPA~TABLET;ORAL~METHYLDOPA~ACCORD HLTHCARE~500MG~A~070085~001~AB~Oct 15,
METHYLDOPA~TABLET;ORAL~METHYLDOPA~DURAMED PHARMS BARR~250MG~A~071006~001~~Dec 16
METHYLDOPA~TABLET;ORAL~METHYLDOPA~DURAMED PHARMS BARR~500MG~A~071009~001~~Dec 16
METHYLDOPA~TABLET;ORAL~METHYLDOPA~HALSEY~125MG~A~071751~001~~Mar 28, 1988~No~DIS
CN~HALSEY DRUG CO INC
METHYLDOPA~TABLET;ORAL~METHYLDOPA~IVAX SUB TEVA PHARMS~250MG~A~070098~001~AB~Feb
METHYLDOPA~TABLET;ORAL~METHYLDOPA~IVAX SUB TEVA PHARMS~500MG~A~070343~001~AB~Feb

METHYLDOPA~TABLET;ORAL~METHYLDOPA~MUTUAL PHARM~125MG~A~070073~001~~Oct 9, 1986~N
METHYLDOPA~TABLET;ORAL~METHYLDOPA~MYLAN~250MG~A~070076~002~AB~Apr 18, 1985~No~RX
METHYLDOPA~TABLET;ORAL~METHYLDOPA~MYLAN~500MG~A~070076~001~AB~Apr 18, 1985~Yes~R
METHYLDOPA~TABLET;ORAL~METHYLDOPA~PAR PHARM~125MG~A~070535~001~~Jan 2, 1987~No~D
METHYLDOPA~TABLET;ORAL~METHYLDOPA~PARKE DAVIS~125MG~A~070331~001~~Apr 15, 1986~N
o~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
METHYLDOPA~TABLET;ORAL~METHYLDOPA~PLIVA~125MG~A~072126~001~~Jul 7, 1988~No~DISCN
~PLIVA INC
~PLIVA INC
~PLIVA INC
METHYLDOPA~TABLET;ORAL~METHYLDOPA~PUREPAC PHARM~125MG~A~070749~001~~Feb 7, 1986~
METHYLDOPA~TABLET;ORAL~METHYLDOPA~ROXANE~125MG~A~070192~001~~Apr 25, 1986~No~DIS
METHYLDOPA~TABLET;ORAL~METHYLDOPA~SANDOZ~125MG~A~071700~001~~Mar 2, 1988~No~DISC
N~SANDOZ INC
METHYLDOPA~TABLET;ORAL~METHYLDOPA~SANDOZ~250MG~N~018934~001~~Jun 29, 1984~No~DIS
CN~SANDOZ INC
METHYLDOPA~TABLET;ORAL~METHYLDOPA~SANDOZ~500MG~N~018934~002~~Jun 29, 1984~No~DIS
CN~SANDOZ INC
METHYLDOPA~TABLET;ORAL~METHYLDOPA~SUPERPHARM~250MG~A~070669~001~~Jun 23, 1989~No
~DISCN~SUPERPHARM CORP
METHYLDOPA~TABLET;ORAL~METHYLDOPA~SUPERPHARM~500MG~A~070670~001~~Jun 23, 1989~No
METHYLDOPA~TABLET;ORAL~METHYLDOPA~TEVA~125MG~A~071105~001~~Dec 5, 1986~No~DISCN~
METHYLDOPA~TABLET;ORAL~METHYLDOPA~WATSON LABS~125MG~A~070245~001~~Feb 25, 1986~N
METHYLDOPA~TABLET;ORAL~METHYLDOPA~WATSON LABS~125MG~A~070260~001~~Jun 24, 1985~N

METHYLDOPA~TABLET;ORAL~METHYLDOPA~WATSON LABS~250MG~A~070703~001~~Jun 6, 1986~No
METHYLDOPA~TABLET;ORAL~METHYLDOPA~WATSON LABS~500MG~A~070625~001~AB~Jun 6, 1986~
CHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND CHLOROTHIAZIDE~PAR PHARM~1
50MG;250MG~A~070783~001~~Nov 6, 1987~No~DISCN~PAR PHARMACEUTICAL INC
CHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND CHLOROTHIAZIDE~PAR PHARM~2
50MG;250MG~A~070654~001~~Nov 6, 1987~No~DISCN~PAR PHARMACEUTICAL INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND HYDROCHLOROTHIAZIDE~D
AVA PHARMS INC~15MG;250MG~A~072507~001~~Jun 2, 1989~No~DISCN~DAVA PHARMACEUTICAL
S INC
S INC
S INC
S INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND HYDROCHLOROTHIAZIDE~I
VAX SUB TEVA PHARMS~15MG;250MG~A~071458~001~~Mar 8, 1988~No~DISCN~IVAX PHARMACEU
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND HYDROCHLOROTHIAZIDE~M
YLAN~15MG;250MG~A~070265~002~~Jan 23, 1986~No~RX~MYLAN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND HYDROCHLOROTHIAZIDE~M
YLAN~25MG;250MG~A~070265~001~~Jan 23, 1986~Yes~RX~MYLAN PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND HYDROCHLOROTHIAZIDE~P
AR PHARM~15MG;250MG~A~070616~001~~Feb 2, 1987~No~DISCN~PAR PHARMACEUTICAL INC
ARKE DAVIS~15MG;250MG~A~071897~001~~Nov 23, 1987~No~DISCN~PARKE DAVIS DIV WARNER
LAMBERT CO
LAMBERT CO

LAMBERT CO
LAMBERT CO
UREPAC PHARM~15MG;250MG~A~070853~001~~Oct 8, 1986~No~DISCN~PUREPAC PHARMACEUTICA
L CO
UREPAC PHARM~25MG;250MG~A~070688~001~~Apr 24, 1986~No~DISCN~PUREPAC PHARMACEUTIC
AL CO
UREPAC PHARM~30MG;500MG~A~070854~001~~Oct 8, 1986~No~DISCN~PUREPAC PHARMACEUTICA
L CO
UREPAC PHARM~50MG;500MG~A~070689~001~~Apr 24, 1986~No~DISCN~PUREPAC PHARMACEUTIC
AL CO
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND HYDROCHLOROTHIAZIDE~S
ANDOZ~15MG;250MG~A~070182~001~~Jan 15, 1986~No~DISCN~SANDOZ INC
ANDOZ~15MG;250MG~A~070829~001~~Mar 9, 1987~No~DISCN~SANDOZ INC
ANDOZ~25MG;250MG~A~070830~001~~Mar 9, 1987~No~DISCN~SANDOZ INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND HYDROCHLOROTHIAZIDE~T
EVA~15MG;250MG~A~071819~001~~Apr 8, 1988~No~DISCN~TEVA PHARMACEUTICALS USA INC
HYDROCHLOROTHIAZIDE; METHYLDOPA~TABLET;ORAL~METHYLDOPA AND HYDROCHLOROTHIAZIDE~W
ATSON LABS~15MG;250MG~A~070365~001~~Mar 19, 1986~No~DISCN~WATSON LABORATORIES IN
C
ATSON LABS~15MG;250MG~A~070958~001~~Feb 6, 1989~No~DISCN~WATSON LABORATORIES INC
ATSON LABS~15MG;250MG~A~071920~001~~Aug 29, 1988~No~DISCN~WATSON LABORATORIES IN
C
ATSON LABS~25MG;250MG~A~070366~001~~Apr 16, 1986~No~DISCN~WATSON LABORATORIES IN
C
ATSON LABS~25MG;250MG~A~070959~001~~Jan 19, 1989~No~DISCN~WATSON LABORATORIES IN
C
C
ATSON LABS~30MG;500MG~A~070367~001~~Mar 19, 1986~No~DISCN~WATSON LABORATORIES IN
C
ATSON LABS~30MG;500MG~A~071069~001~~Jan 19, 1989~No~DISCN~WATSON LABORATORIES IN
C
C
ATSON LABS~50MG;500MG~A~070368~001~~Apr 16, 1986~No~DISCN~WATSON LABORATORIES IN
C
ATSON LABS~50MG;500MG~A~070960~001~~Feb 6, 1989~No~DISCN~WATSON LABORATORIES INC
C
METHYLERGONOVINE MALEATE~TABLET;ORAL~METHYLERGONOVINE MALEATE~NOVEL LABS INC~0.2
MG~A~091577~001~AB~May 2, 2011~No~RX~NOVEL LABORATORIES INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~ABLE~5MG
~A~040404~001~~Mar 29, 2001~No~DISCN~ABLE LABORATORIES INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~ABLE~10M
G~A~040404~002~~Mar 29, 2001~No~DISCN~ABLE LABORATORIES INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~ABLE~20M
G~A~040404~003~~Mar 29, 2001~No~DISCN~ABLE LABORATORIES INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~ACTAVIS
ELIZABETH~5MG~A~040321~001~~Feb 5, 2002~No~DISCN~ACTAVIS ELIZABETH LLC
LABS FL INC~5MG~A~040220~001~AB~Aug 29, 1997~No~RX~ACTAVIS LABORATORIES FL INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~COREPHAR
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~MALLINCK
RODT~5MG~A~040300~001~AB~Nov 27, 1998~No~RX~MALLINCKRODT INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~SUN PHAR
M INDS INC~5MG~A~090710~001~AB~Mar 15, 2012~No~RX~SUN PHARMACEUTICAL INDUSTRIES
INC
INC
INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~UCB INC~
5MG~A~086429~001~AB~Approved Prior to Jan 1, 1982~No~RX~UCB INC
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~METHYLPHENIDATE HYDROCHLORIDE~VINTAGE
PHARMS~5MG~A~202892~001~AB~Sep 23, 2014~No~RX~VINTAGE PHARMACEUTICALS

METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~DURAMED PHARMS BARR~4MG~A~0884
97~001~AB~Feb 21, 1984~No~RX~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES I
NC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~HEATHER~4MG~A~085650~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~JUBILANT CADISTA~4MG~A~040189~
001~AB~Oct 31, 1997~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~JUBILANT CADISTA~8MG~A~040189~
002~AB~Oct 31, 1997~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~JUBILANT CADISTA~16MG~A~040189
~003~AB~Jul 20, 2007~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~JUBILANT CADISTA~32MG~A~040189
~004~AB~Jul 20, 2007~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~PAR PHARM~16MG~A~089207~001~~A
pr 25, 1988~No~DISCN~PAR PHARMACEUTICAL INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~SANDOZ~4MG~A~040194~001~AB~Oct
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~SANDOZ~4MG~A~087341~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~VINTAGE PHARMS~4MG~A~040183~00
1~AB~Dec 22, 1998~No~RX~VINTAGE PHARMACEUTICALS INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~WATSON LABS~4MG~A~040232~001~A
B~Oct 16, 1997~No~RX~WATSON LABORATORIES INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~WATSON LABS~4MG~A~086161~001~~
Feb 9, 1982~No~DISCN~WATSON LABORATORIES INC
METHYLPREDNISOLONE~TABLET;ORAL~METHYLPREDNISOLONE~WATSON LABS~16MG~A~086159~001~
~Feb 9, 1982~No~DISCN~WATSON LABORATORIES INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~IMPAX LABS~10MG~A~080767~002~B
P~Approved Prior to Jan 1, 1982~No~RX~IMPAX LABORATORIES INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~IMPAX LABS~25MG~A~084310~001~B
P~Approved Prior to Jan 1, 1982~No~RX~IMPAX LABORATORIES INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~INWOOD LABS~10MG~A~080839~001~
~Approved Prior to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABOR
ATORIES INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~INWOOD LABS~25MG~A~080973~001~
~Approved Prior to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABOR
ATORIES INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~KV PHARM~10MG~A~084312~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~LANNETT~10MG~A~087092~001~~Nov
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~LANNETT~25MG~A~087111~001~~Jan
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~PARKE DAVIS~10MG~A~084244~001~
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~PARKE DAVIS~25MG~A~084241~001~
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~PUREPAC PHARM~10MG~A~080309~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~PUREPAC PHARM~25MG~A~080310~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~PVT FORM~5MG~A~080214~001~~App
roved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~PVT FORM~10MG~A~080214~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~PVT FORM~25MG~A~080214~003~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~TABLICAPS~10MG~A~080313~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~TABLICAPS~25MG~A~085270~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~WATSON LABS~10MG~A~080933~001~
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~WATSON LABS~25MG~A~080931~001~
METHYLTESTOSTERONE~TABLET;ORAL~METHYLTESTOSTERONE~WEST WARD~10MG~A~084331~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
PREDNISONE~TABLET;ORAL~METICORTEN~SCHERING~1MG~N~009766~002~~Approved Prior to J
an 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
PREDNISONE~TABLET;ORAL~METICORTEN~SCHERING~5MG~N~009766~001~~Approved Prior to J
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~CLONMEL~EQ
10MG BASE~A~072639~001~~May 9, 1991~No~DISCN~CLONMEL HEALTHCARE
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~HALSEY~EQ
10MG BASE~A~070906~001~~Oct 28, 1986~No~DISCN~HALSEY DRUG CO INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~INTERPHARM
~EQ 10MG BASE~A~071213~001~~Sep 24, 1986~No~DISCN~INTERPHARM INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~IPCA LABS
LTD~EQ 5MG BASE~A~078807~001~AB~Jun 12, 2008~No~RX~IPCA LABORATORIES LTD
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~IPCA LABS
LTD~EQ 10MG BASE~A~078807~002~AB~Jun 12, 2008~No~RX~IPCA LABORATORIES LTD
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~MUTUAL PHA
RM~EQ 5MG BASE~A~071536~002~AB~Jan 16, 1997~No~RX~MUTUAL PHARMACEUTICAL CO INC
RM~EQ 10MG BASE~A~070660~001~~Feb 10, 1987~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
RM~EQ 10MG BASE~A~071536~001~~Apr 28, 1993~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~NORTHSTAR
HLTHCARE~EQ 5MG BASE~A~078374~001~AB~Nov 30, 2007~No~RX~NORTHSTAR HEALTHCARE HOL
DINGS LTD
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~NORTHSTAR
HLTHCARE~EQ 10MG BASE~A~078374~002~AB~Nov 30, 2007~No~RX~NORTHSTAR HEALTHCARE HO
LDINGS LTD
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~PAR PHARM~
EQ 10MG BASE~A~070342~001~~Mar 25, 1986~No~DISCN~PAR PHARMACEUTICAL INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~PAR PHARM
INC~EQ 10MG BASE~A~070581~001~AB~Oct 17, 1985~No~RX~PAR PHARMACEUTICAL INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~SANDOZ~EQ
5MG BASE~A~074478~001~~Oct 5, 1995~No~DISCN~SANDOZ INC
10MG BASE~A~070850~001~~Feb 3, 1987~No~DISCN~SANDOZ INC
10MG BASE~A~072215~001~~Jan 30, 1990~No~DISCN~SANDOZ INC
10MG BASE~A~074478~002~~Oct 5, 1995~No~DISCN~SANDOZ INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~SCHERING~E

Q 10MG BASE~A~070598~001~~Feb 2, 1987~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH
CORP
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~SUPERPHARM
~EQ 10MG BASE~A~070926~001~~Jun 26, 1987~No~DISCN~SUPERPHARM CORP
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~TEVA~EQ 5M
G BASE~A~072801~001~AB~Jun 15, 1993~No~RX~TEVA PHARMACEUTICALS USA INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~TEVA~EQ 10
MG BASE~A~070184~001~AB~Jul 29, 1985~No~RX~TEVA PHARMACEUTICALS USA INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~USL PHARMA
~EQ 10MG BASE~A~070339~001~~Jul 29, 1985~No~DISCN~USL PHARMA INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~VINTAGE PH
ARMS~EQ 5MG BASE~A~077878~001~AB~Aug 28, 2006~No~RX~VINTAGE PHARMACEUTICALS INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~VINTAGE PH
ARMS~EQ 10MG BASE~A~077878~002~AB~Aug 28, 2006~No~RX~VINTAGE PHARMACEUTICALS INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~METOCLOPRAMIDE HYDROCHLORIDE~WATSON LAB
S~EQ 5MG BASE~A~072750~001~AB~Dec 28, 1995~No~RX~WATSON LABORATORIES INC
S~EQ 10MG BASE~A~070363~001~~Mar 2, 1987~No~DISCN~WATSON LABORATORIES INC
S~EQ 10MG BASE~A~070453~001~~Jun 6, 1986~No~DISCN~WATSON LABORATORIES INC
S~EQ 10MG BASE~A~070511~001~~Jan 22, 1986~No~DISCN~WATSON LABORATORIES INC
S~EQ 10MG BASE~A~070645~001~~May 11, 1987~No~DISCN~WATSON LABORATORIES INC
S~EQ 10MG BASE~A~071250~001~AB~Feb 3, 1988~No~RX~WATSON LABORATORIES INC
METOLAZONE~TABLET;ORAL~METOLAZONE~MYLAN~2.5MG~A~076698~001~AB~Dec 23, 2003~No~RX
METOLAZONE~TABLET;ORAL~METOLAZONE~MYLAN~5MG~A~076698~002~AB~Oct 19, 2004~No~RX~M
METOLAZONE~TABLET;ORAL~METOLAZONE~MYLAN~10MG~A~076698~003~AB~Oct 19, 2004~No~RX~
METOLAZONE~TABLET;ORAL~METOLAZONE~ROXANE~10MG~A~076482~002~~Apr 29, 2004~No~DISC
METOLAZONE~TABLET;ORAL~METOLAZONE~SANDOZ~2.5MG~A~076732~001~AB~Dec 19, 2003~No~R
X~SANDOZ INC
METOLAZONE~TABLET;ORAL~METOLAZONE~SANDOZ~5MG~A~076466~001~AB~Dec 19, 2003~No~RX~
SANDOZ INC
METOLAZONE~TABLET;ORAL~METOLAZONE~SANDOZ~10MG~A~076466~002~AB~Dec 19, 2003~No~RX
~SANDOZ INC
METOLAZONE~TABLET;ORAL~METOLAZONE~TEVA~2.5MG~A~076600~001~~Jan 6, 2004~No~DISCN~
METOLAZONE~TABLET;ORAL~METOLAZONE~TEVA~5MG~A~076833~001~~Mar 1, 2004~No~DISCN~TE
METOLAZONE~TABLET;ORAL~METOLAZONE~TEVA~10MG~A~075543~003~~Dec 24, 2003~No~DISCN~
METOLAZONE~TABLET;ORAL~METOLAZONE~WATSON LABS~10MG~A~076891~001~~Jul 21, 2004~No
METYRAPONE~TABLET;ORAL~METOPIRONE~HRA PHARMA~250MG~N~012911~001~~Approved Prior
to Jan 1, 1982~No~DISCN~HRA PHARMA LLC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~ALEMBIC PHARMS LTD~25MG~A~20
2871~001~AB~May 28, 2013~No~RX~ALEMBIC PHARMACEUTICALS LTD
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~APOTHECON~50MG~A~074258~001~
~Jan 27, 1994~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~APOTHECON~100MG~A~074258~002
~~Jan 27, 1994~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB

METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~AUROBINDO PHARMA~25MG~A~0777
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~IPCA LABS LTD~25MG~A~078459~
001~AB~Jun 17, 2008~No~RX~IPCA LABORATORIES LTD
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~IPCA LABS LTD~50MG~A~078459~
002~AB~Jun 17, 2008~No~RX~IPCA LABORATORIES LTD
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~IPCA LABS LTD~100MG~A~078459
~003~AB~Jun 17, 2008~No~RX~IPCA LABORATORIES LTD
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~MUTUAL PHARM~25MG~A~073654~0
02~AB~Jul 15, 2009~No~RX~MUTUAL PHARMACEUTICAL CO INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~MUTUAL PHARM~50MG~A~073653~0
01~AB~Dec 21, 1993~No~RX~MUTUAL PHARMACEUTICAL CO INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~MUTUAL PHARM~100MG~A~073654~
001~AB~Dec 21, 1993~No~RX~MUTUAL PHARMACEUTICAL CO INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~MYLAN~25MG~A~076704~001~AB~J
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~MYLAN~50MG~A~073666~001~~Dec
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~MYLAN~50MG~A~076704~002~AB~J
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~MYLAN~100MG~A~073666~002~~De
c 21, 1993~No~DISCN~MYLAN PHARMACEUTICALS INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~MYLAN~100MG~A~076704~003~AB~
Jan 16, 2004~Yes~RX~MYLAN PHARMACEUTICALS INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~PRINSTON INC~50MG~A~074453~0
01~~Apr 27, 1995~No~DISCN~PRINSTON PHARMACEUTICAL INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~PRINSTON INC~100MG~A~074453~
002~~Apr 27, 1995~No~DISCN~PRINSTON PHARMACEUTICAL INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~PUREPAC PHARM~50MG~A~074380~
001~~Jul 29, 1994~No~DISCN~PUREPAC PHARMACEUTICAL CO
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~PUREPAC PHARM~100MG~A~074380
~002~~Jul 29, 1994~No~DISCN~PUREPAC PHARMACEUTICAL CO
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~RUBICON RES PVT LTD~25MG~A~2
00981~001~AB~Oct 28, 2014~No~RX~RUBICON RESEARCH PVT LTD
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~RUBICON RES PVT LTD~50MG~A~2
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~RUBICON RES PVT LTD~100MG~A~
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~SANDOZ~50MG~A~073288~001~AB~
Mar 25, 1994~No~RX~SANDOZ INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~SANDOZ~100MG~A~073289~001~AB
~Mar 25, 1994~No~RX~SANDOZ INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~SUN PHARM INDS INC~25MG~A~07
6670~001~AB~Jan 15, 2004~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
4644~001~AB~Dec 10, 1996~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
74644~002~AB~Dec 10, 1996~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~TEVA~50MG~A~074141~001~AB~Ja
n 31, 1995~No~RX~TEVA PHARMACEUTICALS USA INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~TEVA~50MG~A~074143~001~~Sep
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~TEVA~100MG~A~074141~002~AB~J
an 31, 1995~No~RX~TEVA PHARMACEUTICALS USA INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~TEVA~100MG~A~074143~002~~Sep

METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~TEVA PHARMS~50MG~A~074333~00
1~~Jan 27, 1994~No~DISCN~TEVA PHARMACEUTICALS USA
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~TEVA PHARMS~100MG~A~074333~0
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~WATSON LABS~50MG~A~074217~00
1~AB~May 27, 1994~No~RX~WATSON LABORATORIES INC
METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE~WATSON LABS~100MG~A~074217~0
02~AB~May 27, 1994~No~RX~WATSON LABORATORIES INC
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE~TABLET;ORAL~METOPROLOL TARTRATE AND HYD
ROCHLOROTHIAZIDE~ALEMBIC PHARMS LTD~25MG;50MG~A~202870~001~AB~Nov 6, 2013~No~RX~
ALEMBIC PHARMACEUTICALS LTD
ROCHLOROTHIAZIDE~ALEMBIC PHARMS LTD~25MG;100MG~A~202870~002~AB~Nov 6, 2013~No~RX
ROCHLOROTHIAZIDE~ALEMBIC PHARMS LTD~50MG;100MG~A~202870~003~AB~Nov 6, 2013~No~RX
ROCHLOROTHIAZIDE~MYLAN~25MG;50MG~A~076792~001~AB~Aug 20, 2004~No~RX~MYLAN PHARMA
CEUTICALS
ROCHLOROTHIAZIDE~MYLAN~25MG;100MG~A~076792~002~AB~Aug 20, 2004~No~RX~MYLAN PHARM
ACEUTICALS
ROCHLOROTHIAZIDE~MYLAN~50MG;100MG~A~076792~003~AB~Aug 20, 2004~No~RX~MYLAN PHARM
ACEUTICALS
ROCHLOROTHIAZIDE~SUN PHARM INDS~25MG;50MG~A~090654~001~AB~Jan 19, 2012~No~RX~SUN
ROCHLOROTHIAZIDE~SUN PHARM INDS~25MG;100MG~A~090654~002~AB~Jan 19, 2012~No~RX~SU
N PHARMACEUTICAL INDUSTRIES LTD
ROCHLOROTHIAZIDE~SUN PHARM INDS~50MG;100MG~A~090654~003~AB~Jan 19, 2012~No~RX~SU
N PHARMACEUTICAL INDUSTRIES LTD
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~METRA~FOREST PHARMS~35MG~A~083754~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~FOREST PHARMACEUTICALS INC
METRONIDAZOLE~TABLET;ORAL~METROMIDOL~LABS AF~250MG~A~074523~001~~Oct 24, 1996~No
~DISCN~LABORATORIOS APLICACIONES FARMACEUTICAS SA DE CV
METRONIDAZOLE~TABLET;ORAL~METROMIDOL~LABS AF~500MG~A~074523~002~~Oct 24, 1996~No
~DISCN~LABORATORIOS APLICACIONES FARMACEUTICAS SA DE CV
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~ABLE~250MG~A~076519~001~~Jun 27, 2003~No
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~ABLE~500MG~A~076519~002~~Jun 27, 2003~No
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~ALEMBIC PHARMS LTD~250MG~A~079067~001~AB
~Mar 13, 2009~No~RX~ALEMBIC PHARMACEUTICALS LTD
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~ALEMBIC PHARMS LTD~500MG~A~079067~002~AB
~Mar 13, 2009~No~RX~ALEMBIC PHARMACEUTICALS LTD
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~HALSEY~250MG~A~070021~001~~Apr 2, 1985~N
o~DISCN~HALSEY DRUG CO INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~HALSEY~500MG~A~070593~001~~Feb 27, 1986~
No~DISCN~HALSEY DRUG CO INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~IVAX SUB TEVA PHARMS~250MG~N~018517~001~
CEUTICALS USA
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~IVAX SUB TEVA PHARMS~500MG~N~018517~002~
~May 5, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~LNK~250MG~N~019029~001~~Apr 10, 1984~No~
DISCN~LNK INTERNATIONAL INC

METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~MUTUAL PHARM~250MG~A~070772~001~AB~Jul 1
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~MUTUAL PHARM~250MG~N~018818~001~~Feb 16,
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~MUTUAL PHARM~500MG~A~070773~001~AB~Jul 1
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~MUTUAL PHARM~500MG~N~018818~002~~Feb 16,
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~PAR PHARM~250MG~N~018845~001~~Aug 18, 19
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~PAR PHARM~500MG~N~018930~001~~Aug 18, 19
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~PLIVA~500MG~A~070033~001~AB~Dec 6, 1984~
No~RX~PLIVA INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~SANDOZ~250MG~N~018620~001~~Mar 4, 1982~N
o~DISCN~SANDOZ INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~SANDOZ~250MG~N~018740~001~~Oct 22, 1982~
No~DISCN~SANDOZ INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~SANDOZ~500MG~N~018620~002~~Jun 2, 1983~N
o~DISCN~SANDOZ INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~SANDOZ~500MG~N~018740~002~~Oct 22, 1982~
No~DISCN~SANDOZ INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~SUPERPHARM~250MG~A~070008~001~~Dec 11, 1
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~SUPERPHARM~500MG~A~070009~001~~Dec 11, 1
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~TEVA PHARMS USA~250MG~A~070027~001~AB~No
v 6, 1984~No~RX~TEVA PHARMACEUTICALS USA INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~UNICHEM LABS LTD~250MG~A~203458~001~AB~J
an 22, 2014~No~RX~UNICHEM LABORATORIES LTD
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~UNICHEM LABS LTD~500MG~A~203458~002~AB~J
an 22, 2014~No~RX~UNICHEM LABORATORIES LTD
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~VIVIMED LABS~250MG~A~070040~001~~Jan 29,
1985~No~DISCN~VIVIMED LABS ALATHUR PRIVATE LTD
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~VIVIMED LABS~500MG~A~070039~001~~Jan 29,
1985~No~DISCN~VIVIMED LABS ALATHUR PRIVATE LTD
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~WATSON LABS~250MG~A~070035~001~AB~Dec 20
, 1984~No~RX~WATSON LABORATORIES INC
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~WATSON LABS~250MG~N~018599~001~~Sep 17,
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~WATSON LABS~250MG~N~018764~001~~Sep 17,
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~WATSON LABS~500MG~N~018599~002~~Feb 13,
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~WATSON LABS~500MG~N~018764~002~~Dec 20,
METRONIDAZOLE~TABLET;ORAL~METRONIDAZOLE~WATSON LABS INC~500MG~A~070044~001~AB~Fe
b 8, 1985~No~RX~WATSON LABORATORIES INC
LOVASTATIN~TABLET;ORAL~MEVACOR~MERCK~10MG~N~019643~002~~Mar 28, 1991~No~DISCN~ME
RCK RESEARCH LABORATORIES DIV MERCK CO INC
LOVASTATIN~TABLET;ORAL~MEVACOR~MERCK~20MG~N~019643~003~~Aug 31, 1987~No~DISCN~ME
LOVASTATIN~TABLET;ORAL~MEVACOR~MERCK~40MG~N~019643~004~~Dec 14, 1988~No~DISCN~ME
TELMISARTAN~TABLET;ORAL~MICARDIS~BOEHRINGER INGELHEIM~20MG~N~020850~003~AB~Apr 4
, 2000~No~RX~BOEHRINGER INGELHEIM
TELMISARTAN~TABLET;ORAL~MICARDIS~BOEHRINGER INGELHEIM~40MG~N~020850~001~AB~Nov 1
0, 1998~No~RX~BOEHRINGER INGELHEIM
TELMISARTAN~TABLET;ORAL~MICARDIS~BOEHRINGER INGELHEIM~80MG~N~020850~002~AB~Nov 1
0, 1998~Yes~RX~BOEHRINGER INGELHEIM
HYDROCHLOROTHIAZIDE; TELMISARTAN~TABLET;ORAL~MICARDIS HCT~BOEHRINGER INGELHEIM~1
2.5MG;40MG~N~021162~001~AB~Nov 17, 2000~No~RX~BOEHRINGER INGELHEIM
2.5MG;80MG~N~021162~002~AB~Nov 17, 2000~No~RX~BOEHRINGER INGELHEIM
5MG;80MG~N~021162~003~AB~Apr 19, 2004~Yes~RX~BOEHRINGER INGELHEIM
ASPIRIN; MEPROBAMATE~TABLET;ORAL~MICRAININ~MEDPOINTE PHARM HLC~325MG;200MG~A~084
978~001~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOI
NTE HEALTHCARE INC
GLYBURIDE~TABLET;ORAL~MICRONASE~PHARMACIA AND UPJOHN~1.25MG~N~017498~001~~May 1,
GLYBURIDE~TABLET;ORAL~MICRONASE~PHARMACIA AND UPJOHN~2.5MG~N~017498~002~~May 1,
GLYBURIDE~TABLET;ORAL~MICRONASE~PHARMACIA AND UPJOHN~5MG~N~017498~003~~May 1, 19
SULFAMETHIZOLE~TABLET;ORAL~MICROSUL~FOREST PHARMS~1GM~A~086012~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~FOREST PHARMACEUTICALS INC
AMILORIDE HYDROCHLORIDE~TABLET;ORAL~MIDAMOR~PADDOCK LLC~5MG~N~018200~001~AB~Appr
oved Prior to Jan 1, 1982~No~RX~PADDOCK LABORATORIES LLC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~APOTEX INC~2.5MG~A~0
77746~001~AB~Sep 12, 2006~No~RX~APOTEX INC ETOBICOKE SITE
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~APOTEX INC~5MG~A~077
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~APOTEX INC~10MG~A~07
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~IMPAX PHARMS~2.5MG~A
~076449~001~AB~May 27, 2004~No~RX~IMPAX PHARMACEUTICALS
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~IMPAX PHARMS~5MG~A~0
76449~002~AB~May 27, 2004~No~RX~IMPAX PHARMACEUTICALS
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~IMPAX PHARMS~10MG~A~
076449~003~AB~Dec 16, 2005~No~RX~IMPAX PHARMACEUTICALS
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~MYLAN PHARMS INC~2.5
MG~A~076577~001~AB~Sep 10, 2003~No~RX~MYLAN PHARMACEUTICALS INC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~MYLAN PHARMS INC~5MG
~A~076577~002~AB~Sep 10, 2003~Yes~RX~MYLAN PHARMACEUTICALS INC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~MYLAN PHARMS INC~10M
G~A~076577~003~AB~Sep 10, 2003~No~RX~MYLAN PHARMACEUTICALS INC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~SANDOZ~2.5MG~A~07651
4~001~AB~Sep 11, 2003~No~RX~SANDOZ INC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~SANDOZ~5MG~A~076514~
002~AB~Sep 11, 2003~No~RX~SANDOZ INC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~MIDODRINE HYDROCHLORIDE~SANDOZ~10MG~A~076514
~003~AB~Jul 2, 2004~No~RX~SANDOZ INC
IBUPROFEN~TABLET;ORAL~MIDOL~BAYER~200MG~A~070591~001~~Sep 2, 1987~No~DISCN~BAYER
HEALTHCARE LLC
IBUPROFEN~TABLET;ORAL~MIDOL~BAYER~200MG~A~071001~001~~Sep 2, 1987~No~DISCN~BAYER
HEALTHCARE LLC
MIFEPRISTONE~TABLET;ORAL~MIFEPREX~DANCO LABS LLC~200MG~N~020687~001~~Sep 28, 200
0~Yes~RX~DANCO LABORATORIES LLC
MIGLITOL~TABLET;ORAL~MIGLITOL~ORIENT PHARMA CO LTD~25MG~A~203965~001~AA~Feb 24,
2015~No~RX~ORIENT PHARMA CO LTD
CLOMIPHENE CITRATE~TABLET;ORAL~MILOPHENE~MILEX~50MG~A~072196~001~~Dec 20, 1988~N
o~DISCN~MILEX PRODUCTS INC
ESTROGENS, CONJUGATED; MEPROBAMATE~TABLET;ORAL~MILPREM-200~MEDPOINTE PHARM HLC~0
.45MG;200MG~N~011045~002~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARM
ACEUTICALS MEDPOINTE HEALTHCARE INC

ESTROGENS, CONJUGATED; MEPROBAMATE~TABLET;ORAL~MILPREM-400~MEDPOINTE PHARM HLC~0
.45MG;400MG~N~011045~001~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARM
ACEUTICALS MEDPOINTE HEALTHCARE INC
MEPROBAMATE~TABLET;ORAL~MILTOWN~MEDPOINTE PHARM HLC~200MG~N~009698~004~~Approved
Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE IN
C
MEPROBAMATE~TABLET;ORAL~MILTOWN~MEDPOINTE PHARM HLC~400MG~N~009698~002~~Approved
C
MEPROBAMATE~TABLET;ORAL~MILTOWN~MEDPOINTE PHARM HLC~600MG~A~083919~001~~Approved
C
MINOCYCLINE HYDROCHLORIDE~TABLET;ORAL~MINOCYCLINE HYDROCHLORIDE~DR REDDYS LABS L
TD~EQ 50MG BASE~A~065436~001~AB~Dec 26, 2007~No~RX~DR REDDYS LABORATORIES LTD
MINOCYCLINE HYDROCHLORIDE~TABLET;ORAL~MINOCYCLINE HYDROCHLORIDE~PAR PHARM~EQ 50M
G BASE~A~065131~001~AB~Apr 16, 2003~No~RX~PAR PHARMACEUTICAL INC
MINOCYCLINE HYDROCHLORIDE~TABLET;ORAL~MINOCYCLINE HYDROCHLORIDE~PAR PHARM~EQ 75M
G BASE~A~065131~002~AB~Apr 16, 2003~No~RX~PAR PHARMACEUTICAL INC
MINOCYCLINE HYDROCHLORIDE~TABLET;ORAL~MINOCYCLINE HYDROCHLORIDE~PAR PHARM~EQ 100
MG BASE~A~065131~003~AB~Apr 16, 2003~Yes~RX~PAR PHARMACEUTICAL INC
MINOCYCLINE HYDROCHLORIDE~TABLET;ORAL~MINOCYCLINE HYDROCHLORIDE~RANBAXY~EQ 50MG
BASE~A~065156~001~AB~Jan 6, 2004~No~RX~RANBAXY LABORATORIES LTD
MINOCYCLINE HYDROCHLORIDE~TABLET;ORAL~MINOCYCLINE HYDROCHLORIDE~TRIAX PHARMS~EQ
50MG BASE~N~050451~003~~Aug 10, 1982~No~DISCN~TRIAX PHARMACEUTICALS LLC
MINOCYCLINE HYDROCHLORIDE~TABLET;ORAL~MINOCYCLINE HYDROCHLORIDE~TRIAX PHARMS~EQ
100MG BASE~N~050451~002~~Aug 10, 1982~No~DISCN~TRIAX PHARMACEUTICALS LLC
MINOXIDIL~TABLET;ORAL~MINODYL~QUANTUM PHARMICS~2.5MG~A~072153~001~~Jul 13, 1988~
No~DISCN~QUANTUM PHARMICS LTD
MINOXIDIL~TABLET;ORAL~MINODYL~QUANTUM PHARMICS~10MG~A~071534~001~~Mar 19, 1987~N
o~DISCN~QUANTUM PHARMICS LTD
MINOXIDIL~TABLET;ORAL~MINOXIDIL~MUTUAL PHARM~2.5MG~A~072708~001~AB~Dec 14, 1995~
MINOXIDIL~TABLET;ORAL~MINOXIDIL~MUTUAL PHARM~10MG~A~072709~001~AB~Dec 14, 1995~N
o~RX~MUTUAL PHARMACEUTICAL CO INC
MINOXIDIL~TABLET;ORAL~MINOXIDIL~PAR PHARM~2.5MG~A~071826~001~AB~Nov 14, 1988~No~
RX~PAR PHARMACEUTICAL INC
MINOXIDIL~TABLET;ORAL~MINOXIDIL~PAR PHARM~10MG~A~071839~001~AB~Nov 14, 1988~No~R
MINOXIDIL~TABLET;ORAL~MINOXIDIL~ROYCE LABS~2.5MG~A~071799~001~~Nov 10, 1987~No~D
ISCN~ROYCE LABORATORIES INC
MINOXIDIL~TABLET;ORAL~MINOXIDIL~ROYCE LABS~10MG~A~071796~001~~Nov 10, 1987~No~DI
SCN~ROYCE LABORATORIES INC
MINOXIDIL~TABLET;ORAL~MINOXIDIL~USL PHARMA~2.5MG~A~071537~001~~Dec 16, 1988~No~D
ISCN~USL PHARMA INC
MINOXIDIL~TABLET;ORAL~MINOXIDIL~WATSON LABS~2.5MG~A~071344~001~AB~Mar 3, 1987~No
MINOXIDIL~TABLET;ORAL~MINOXIDIL~WATSON LABS~10MG~A~071345~001~AB~Mar 3, 1987~Yes
ANISINDIONE~TABLET;ORAL~MIRADON~SCHERING~50MG~N~010909~003~~Approved Prior to Ja
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~MIRAPEX~BOEHRINGER INGELHEIM~0.125MG~N~0
20667~001~AB~Jul 1, 1997~No~RX~BOEHRINGER INGELHEIM

0667~002~AB~Jul 1, 1997~Yes~RX~BOEHRINGER INGELHEIM
667~006~AB~Feb 12, 1998~No~RX~BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~MIRAPEX~BOEHRINGER INGELHEIM~1MG~N~02066
0667~004~~Jul 1, 1997~No~DISCN~BOEHRINGER INGELHEIM
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~ACTAVIS ELIZABETH~15MG~A~076241~001~~Jun 25,
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~ACTAVIS LABS FL INC~15MG~A~076336~001~AB~Jun
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~APOTEX INC~15MG~A~077666~001~AB~Aug 22, 2007
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~AUROBINDO~7.5MG~A~076921~001~AB~Oct 22, 2004
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~AUROBINDO~15MG~A~076921~002~AB~Oct 22, 2004~
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~IVAX SUB TEVA PHARMS~15MG~A~076244~001~~Dec
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~MYLAN~15MG~A~076122~001~AB~Jun 19, 2003~No~R
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~MYLAN PHARMS INC~15MG~A~076176~001~AB~Jun 19

MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~ROXANE~15MG~A~076270~001~~Jun 19, 2003~No~DI
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~SANDOZ~15MG~A~076189~001~~Jun 19, 2003~No~DI
SCN~SANDOZ INC
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~SANDOZ~15MG~A~076219~001~AB~Jun 19, 2003~No~
RX~SANDOZ INC
SCN~SANDOZ INC
RX~SANDOZ INC
SCN~SANDOZ INC
RX~SANDOZ INC
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~SUN PHARM INDS INC~7.5MG~A~076541~004~AB~Apr
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~SUN PHARM INDS INC~15MG~A~076541~001~AB~Apr
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~TEVA~15MG~A~076119~001~AB~Jan 24, 2003~No~RX
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~TEVA~30MG~A~076119~002~AB~Jan 24, 2003~No~RX
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~TEVA~45MG~A~076119~003~AB~Jun 19, 2003~No~RX
MIRTAZAPINE~TABLET;ORAL~MIRTAZAPINE~WATSON LABS~15MG~A~076312~001~AB~Jun 19, 200
MISOPROSTOL~TABLET;ORAL~MISOPROSTOL~IVAX SUB TEVA PHARMS~0.1MG~A~076095~001~AB~J
MISOPROSTOL~TABLET;ORAL~MISOPROSTOL~IVAX SUB TEVA PHARMS~0.2MG~A~076095~002~AB~J
MISOPROSTOL~TABLET;ORAL~MISOPROSTOL~NOVEL LABS INC~0.1MG~A~091667~001~AB~Jul 25,
MISOPROSTOL~TABLET;ORAL~MISOPROSTOL~NOVEL LABS INC~0.2MG~A~091667~002~AB~Jul 25,
MOLINDONE HYDROCHLORIDE~TABLET;ORAL~MOBAN~ENDO PHARMS~5MG **Federal Register det
reasons**~N~017111~004~~Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUTI
CALS INC
MOLINDONE HYDROCHLORIDE~TABLET;ORAL~MOBAN~ENDO PHARMS~10MG **Federal Register de
ICALS INC
ICALS INC
ICALS INC
MOLINDONE HYDROCHLORIDE~TABLET;ORAL~MOBAN~ENDO PHARMS~100MG **Federal Register d
TICALS INC
MELOXICAM~TABLET;ORAL~MOBIC~BOEHRINGER INGELHEIM~7.5MG~N~020938~001~AB~Apr 13, 2
000~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
MELOXICAM~TABLET;ORAL~MOBIC~BOEHRINGER INGELHEIM~15MG~N~020938~002~AB~Aug 23, 20
MODAFINIL~TABLET;ORAL~MODAFINIL~ALEMBIC LTD~100MG~A~202700~001~AB~Oct 18, 2012~N
o~RX~ALEMBIC LTD
MODAFINIL~TABLET;ORAL~MODAFINIL~ALEMBIC LTD~200MG~A~202700~002~AB~Oct 18, 2012~N
o~RX~ALEMBIC LTD
MODAFINIL~TABLET;ORAL~MODAFINIL~APOTEX INC~100MG~A~077667~001~AB~Feb 3, 2014~No~
RX~APOTEX INC
MODAFINIL~TABLET;ORAL~MODAFINIL~APOTEX INC~200MG~A~077667~002~AB~Feb 3, 2014~No~
RX~APOTEX INC
MODAFINIL~TABLET;ORAL~MODAFINIL~AUROBINDO PHARMA LTD~100MG~A~202566~001~AB~Sep 2
MODAFINIL~TABLET;ORAL~MODAFINIL~AUROBINDO PHARMA LTD~200MG~A~202566~002~AB~Sep 2
MODAFINIL~TABLET;ORAL~MODAFINIL~CARLSBAD~100MG~A~076715~001~AB~Nov 1, 2012~No~RX
MODAFINIL~TABLET;ORAL~MODAFINIL~CARLSBAD~200MG~A~076715~002~AB~Nov 1, 2012~No~RX
MODAFINIL~TABLET;ORAL~MODAFINIL~HIKMA PHARMS~100MG~A~090543~001~AB~Sep 26, 2012~
No~RX~HIKMA PHARMACEUTICALS
MODAFINIL~TABLET;ORAL~MODAFINIL~HIKMA PHARMS~200MG~A~090543~002~AB~Sep 26, 2012~
No~RX~HIKMA PHARMACEUTICALS
MODAFINIL~TABLET;ORAL~MODAFINIL~MYLAN PHARMS INC~100MG~A~076594~001~AB~Jul 16, 2
MODAFINIL~TABLET;ORAL~MODAFINIL~MYLAN PHARMS INC~200MG~A~076594~002~AB~Jul 16, 2
MODAFINIL~TABLET;ORAL~MODAFINIL~ORCHID HLTHCARE~100MG~A~078963~001~AB~Sep 26, 20
MODAFINIL~TABLET;ORAL~MODAFINIL~ORCHID HLTHCARE~200MG~A~078963~002~AB~Sep 26, 20
RESCINNAMINE~TABLET;ORAL~MODERIL~PFIZER~0.25MG~N~010686~003~~Approved Prior to J
RESCINNAMINE~TABLET;ORAL~MODERIL~PFIZER~0.5MG~N~010686~006~~Approved Prior to Ja
n 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~MODURETIC 5-50~MERCK~EQ
5MG ANHYDROUS;50MG~N~018201~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK R
ESEARCH LABORATORIES DIV MERCK CO INC
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE~APOTEX INC~7.5MG~A~0
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE~APOTEX INC~15MG~A~07
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE~GLENMARK GENERICS~7.
5MG~A~090416~001~AB~Mar 30, 2010~No~RX~GLENMARK GENERICS LTD
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE~GLENMARK GENERICS~15
MG~A~090416~002~AB~Mar 30, 2010~No~RX~GLENMARK GENERICS LTD
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE~PADDOCK LLC~7.5MG~A~
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE~PADDOCK LLC~15MG~A~0
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE~TEVA~7.5MG~A~076204~

MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE~TEVA~15MG~A~076204~0
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~MOEXIPRIL HYDROCHLORIDE
AND HYDROCHLOROTHIAZIDE~GLENMARK PHARMS~12.5MG;7.5MG~A~090718~001~AB~Mar 17, 20
10~No~RX~GLENMARK PHARMACEUTICALS LTD
AND HYDROCHLOROTHIAZIDE~GLENMARK PHARMS~12.5MG;15MG~A~090718~002~AB~Mar 17, 201
0~No~RX~GLENMARK PHARMACEUTICALS LTD
AND HYDROCHLOROTHIAZIDE~GLENMARK PHARMS~25MG;15MG~A~090718~003~AB~Mar 17, 2010~
No~RX~GLENMARK PHARMACEUTICALS LTD
AND HYDROCHLOROTHIAZIDE~PADDOCK LLC~12.5MG;7.5MG~A~090096~001~~Sep 25, 2008~No~
DISCN~PADDOCK LABORATORIES LLC
AND HYDROCHLOROTHIAZIDE~PADDOCK LLC~12.5MG;15MG~A~090096~002~~Sep 25, 2008~No~D
ISCN~PADDOCK LABORATORIES LLC
AND HYDROCHLOROTHIAZIDE~PADDOCK LLC~25MG;15MG~A~090096~003~~Sep 25, 2008~No~DIS
CN~PADDOCK LABORATORIES LLC
AND HYDROCHLOROTHIAZIDE~TEVA~12.5MG;7.5MG~A~076980~001~AB~Mar 7, 2007~No~RX~TEV
AND HYDROCHLOROTHIAZIDE~TEVA~12.5MG;15MG~A~076980~003~AB~Mar 7, 2007~No~RX~TEVA
AND HYDROCHLOROTHIAZIDE~TEVA~25MG;15MG~A~076980~002~AB~Mar 7, 2007~No~RX~TEVA P
AND HYDROCHOLROTHIAZIDE~HERITAGE PHARMS INC~12.5MG;7.5MG~A~202150~001~AB~Mar 7,
AND HYDROCHOLROTHIAZIDE~HERITAGE PHARMS INC~12.5MG;15MG~A~202150~002~AB~Mar 7,
AND HYDROCHOLROTHIAZIDE~HERITAGE PHARMS INC~25MG;15MG~A~202150~003~AB~Mar 7, 20
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE~T
ABLET;ORAL~MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE~NOVEL LABS IN
C~0.398GM;1.102GM~A~079247~001~~Dec 30, 2011~No~DISCN~NOVEL LABORATORIES INC
ISOSORBIDE MONONITRATE~TABLET;ORAL~MONOKET~KREMERS URBAN PHARMS~10MG~N~020215~00
2~AB~Jun 30, 1993~No~RX~KREMERS URBAN PHARMACEUTICALS INC
ISOSORBIDE MONONITRATE~TABLET;ORAL~MONOKET~KREMERS URBAN PHARMS~20MG~N~020215~00
1~AB~Jun 30, 1993~Yes~RX~KREMERS URBAN PHARMACEUTICALS INC
FOSINOPRIL SODIUM~TABLET;ORAL~MONOPRIL~BRISTOL MYERS SQUIBB~10MG~N~019915~002~~M
ay 16, 1991~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
ay 16, 1991~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
ar 28, 1995~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE~TABLET;ORAL~MONOPRIL-HCT~BRISTOL MYERS SQ
UIBB~10MG;12.5MG~N~020286~002~~Nov 30, 1994~No~DISCN~BRISTOL MYERS SQUIBB
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE~TABLET;ORAL~MONOPRIL-HCT~BRISTOL MYERS SQ
UIBB~20MG;12.5MG~N~020286~001~~Nov 30, 1994~No~DISCN~BRISTOL MYERS SQUIBB
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~ACCORD HLTHCARE~EQ 10MG BASE~A
~202717~001~AB~Sep 21, 2012~No~RX~ACCORD HEALTHCARE INC
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~APOTEX CORP~EQ 10MG BASE~A~201
294~001~AB~Aug 3, 2012~No~RX~APOTEX CORP

MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~AUROBINDO PHARMA LTD~EQ 10MG B
ASE~A~202468~001~AB~Aug 3, 2012~No~RX~AUROBINDO PHARMA LTD
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~DR REDDYS LABS LTD~EQ 10MG BAS
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~GLENMARK GENERICS~EQ 10MG BASE
~A~090926~001~AB~Aug 3, 2012~No~RX~GLENMARK GENERICS LTD
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~HETERO LABS LTD V~EQ 10MG BASE
~A~202843~001~AB~Sep 10, 2014~No~RX~HETERO LABS LTD UNIT V
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~KUDCO IRELAND~EQ 10MG BASE~A~2
01522~001~AB~Aug 3, 2012~No~RX~KUDCO IRELAND LTD
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~MACLEODS PHARMS LTD~EQ 10MG BA
SE~A~203366~001~AB~Sep 11, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~MYLAN PHARMS INC~EQ 10MG BASE~
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~ROXANE~EQ 10MG BASE~A~090655~0
01~AB~Aug 3, 2012~No~RX~ROXANE LABORATORIES INC
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~SANDOZ INC~EQ 10MG BASE~A~2008
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~TEVA PHARMS~EQ 10MG BASE~A~078
605~001~AB~Aug 3, 2012~No~RX~TEVA PHARMACEUTICALS USA
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~TORRENT PHARMS LTD~EQ 10MG BAS
E~A~201515~001~AB~Aug 3, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~UNIMARK REMEDIES LTD~EQ 10MG B
ASE~A~202859~001~AB~Oct 30, 2014~No~RX~UNIMARK REMEDIES LTD
MONTELUKAST SODIUM~TABLET;ORAL~MONTELUKAST SODIUM~VINTAGE PHARMS LLC~EQ 10MG BAS
E~A~091576~001~AB~Aug 3, 2012~No~RX~VINTAGE PHARMACEUTICALS LLC
MORPHINE SULFATE~TABLET;ORAL~MORPHINE SULFATE~ROXANE~15MG~N~022207~001~~Mar 17,
MORPHINE SULFATE~TABLET;ORAL~MORPHINE SULFATE~ROXANE~30MG~N~022207~002~~Mar 17,
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE~TABLET;ORAL~MOTOFEN~SEBELA IRELAND LTD
~0.025MG;1MG~N~017744~002~~Approved Prior to Jan 1, 1982~Yes~RX~SEBELA IRELAND L
TD
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE~TABLET;ORAL~MOTOFEN HALF-STRENGTH~SEBE
LA IRELAND LTD~0.025MG;0.5MG~N~017744~001~~Approved Prior to Jan 1, 1982~No~DISC
N~SEBELA IRELAND LTD
IBUPROFEN~TABLET;ORAL~MOTRIN~MCNEIL CONSUMER~300MG~N~017463~003~~Approved Prior
to Jan 1, 1982~No~DISCN~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
IBUPROFEN~TABLET;ORAL~MOTRIN~MCNEIL CONSUMER~800MG~N~017463~005~~May 22, 1985~No
~DISCN~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
IBUPROFEN~TABLET;ORAL~MOTRIN~MCNEIL PED~100MG~N~020418~001~~Nov 16, 1994~No~DISC
N~MCNEIL PEDIATRICS
IBUPROFEN~TABLET;ORAL~MOTRIN IB~MCNEIL~200MG~N~019012~003~~Dec 17, 1990~Yes~OTC~
MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
IBUPROFEN~TABLET;ORAL~MOTRIN MIGRAINE PAIN~MCNEIL~200MG~N~019012~004~~Feb 25, 20
00~Yes~OTC~MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
NALOXEGOL OXALATE~TABLET;ORAL~MOVANTIK~ASTRAZENECA PHARMS~EQ 12.5MG BASE~N~20476
0~001~~Sep 16, 2014~No~RX~ASTRAZENECA PHARMACEUTICALS LP
NALOXEGOL OXALATE~TABLET;ORAL~MOVANTIK~ASTRAZENECA PHARMS~EQ 25MG BASE~N~204760~
002~~Sep 16, 2014~Yes~RX~ASTRAZENECA PHARMACEUTICALS LP
MOXIFLOXACIN HYDROCHLORIDE~TABLET;ORAL~MOXIFLOXACIN HYDROCHLORIDE~AUROBINDO PHAR
MA LTD~EQ 400MG BASE~A~202632~001~AB~Mar 4, 2014~No~RX~AUROBINDO PHARMA LTD
MOXIFLOXACIN HYDROCHLORIDE~TABLET;ORAL~MOXIFLOXACIN HYDROCHLORIDE~DR REDDYS LABS
LTD~EQ 400MG BASE~A~076938~001~AB~Mar 4, 2014~No~RX~DR REDDYS LABORATORIES LTD
MOXIFLOXACIN HYDROCHLORIDE~TABLET;ORAL~MOXIFLOXACIN HYDROCHLORIDE~TEVA PHARMS US
A~EQ 400MG BASE~A~077437~001~AB~Feb 18, 2014~No~RX~TEVA PHARMACEUTICALS USA

MOXIFLOXACIN HYDROCHLORIDE~TABLET;ORAL~MOXIFLOXACIN HYDROCHLORIDE~TORRENT PHARMS
LTD~EQ 400MG BASE~A~200160~001~AB~Apr 3, 2014~No~RX~TORRENT PHARMACEUTICALS LTD
DRONEDARONE HYDROCHLORIDE~TABLET;ORAL~MULTAQ~SANOFI AVENTIS US~EQ 400MG BASE~N~0
22425~001~~Jul 1, 2009~Yes~RX~SANOFI AVENTIS US LLC
ETHAMBUTOL HYDROCHLORIDE~TABLET;ORAL~MYAMBUTOL~STI PHARMA LLC~100MG~N~016320~001
~AB~Approved Prior to Jan 1, 1982~No~RX~STI PHARMA LLC
~~Approved Prior to Jan 1, 1982~No~DISCN~STI PHARMA LLC
~AB~Approved Prior to Jan 1, 1982~Yes~RX~STI PHARMA LLC
~~Approved Prior to Jan 1, 1982~No~DISCN~STI PHARMA LLC
NEOMYCIN SULFATE~TABLET;ORAL~MYCIFRADIN~PHARMACIA AND UPJOHN~EQ 350MG BASE~A~060
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~ACCORD HLTHCARE~500MG~A~
065416~001~AB~May 4, 2009~No~RX~ACCORD HEALTHCARE INC
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~ALKEM LABS LTD~500MG~A~0
91249~001~AB~Nov 4, 2011~No~RX~ALKEM LABORATORIES LTD
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~APOTEX~500MG~A~090499~00
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~CADISTA PHARMS~500MG~A~0
90661~001~AB~Dec 15, 2014~No~RX~CADISTA PHARMACEUTICALS INC
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~DR REDDYS LABS LTD~500MG
~A~090464~001~~Sep 13, 2010~No~DISCN~DR REDDYS LABORATORIES LTD
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~MYLAN~500MG~A~065521~001
~AB~May 4, 2009~No~RX~MYLAN PHARMACEUTICALS INC
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~ROXANE~500MG~A~065413~00
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~SANDOZ~500MG~A~065451~00
1~AB~Oct 15, 2008~No~RX~SANDOZ INC
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~STRIDES PHARMA~500MG~A~0
90456~001~AB~Jun 10, 2010~No~RX~STRIDES PHARMA GLOBAL PTE LTD
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~TEVA PHARMS~500MG~A~0654
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~VINTAGE PHARMS LLC~500MG
~A~090606~001~AB~Jul 16, 2010~No~RX~VINTAGE PHARMACEUTICALS LLC
MYCOPHENOLATE MOFETIL~TABLET;ORAL~MYCOPHENOLATE MOFETIL~ZYDUS PHARMS USA INC~500
MG~A~065477~001~~May 4, 2009~No~DISCN~ZYDUS PHARMACEUTICALS USA INC
NYSTATIN~TABLET;ORAL~MYCOSTATIN~DELCOR ASSET CORP~500,000 UNITS~A~060574~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~DELCOR ASSET CORP
METOLAZONE~TABLET;ORAL~MYKROX~UCB INC~0.5MG~N~019532~001~~Oct 30, 1987~No~DISCN~
UCB INC
BUSULFAN~TABLET;ORAL~MYLERAN~ASPEN GLOBAL~2MG~N~009386~001~~Approved Prior to Ja
n 1, 1982~Yes~RX~ASPEN GLOBAL INC
BETHANECHOL CHLORIDE~TABLET;ORAL~MYOTONACHOL~GLENWOOD~5MG~A~084188~001~~Approved
Prior to Jan 1, 1982~No~DISCN~GLENWOOD INC
BETHANECHOL CHLORIDE~TABLET;ORAL~MYOTONACHOL~GLENWOOD~10MG~A~084188~003~~Approve
d Prior to Jan 1, 1982~No~DISCN~GLENWOOD INC
BETHANECHOL CHLORIDE~TABLET;ORAL~MYOTONACHOL~GLENWOOD~25MG~A~084188~004~~Approve
d Prior to Jan 1, 1982~No~DISCN~GLENWOOD INC
PRIMIDONE~TABLET;ORAL~MYSOLINE~VALEANT~50MG~N~009170~003~AB~Approved Prior to Ja
n 1, 1982~Yes~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
PRIMIDONE~TABLET;ORAL~MYSOLINE~VALEANT~250MG~N~009170~002~AB~Approved Prior to J
an 1, 1982~No~RX~VALEANT PHARMACEUTICALS INTERNATIONAL
AMBENONIUM CHLORIDE~TABLET;ORAL~MYTELASE~SANOFI AVENTIS US~10MG~N~010155~002~~Ap
NABUMETONE~TABLET;ORAL~NABUMETONE~APOTEX INC~500MG~A~090427~001~AB~Dec 30, 2011~
No~RX~APOTEX INC
NABUMETONE~TABLET;ORAL~NABUMETONE~APOTEX INC~750MG~A~090427~002~AB~Dec 30, 2011~
No~RX~APOTEX INC
NABUMETONE~TABLET;ORAL~NABUMETONE~COPLEY PHARM~750MG~A~075179~001~~Jun 6, 2000~N
o~DISCN~COPLEY PHARMACEUTICAL INC
NABUMETONE~TABLET;ORAL~NABUMETONE~DR REDDYS LABS LTD~500MG~A~078420~001~~Sep 24,
NABUMETONE~TABLET;ORAL~NABUMETONE~DR REDDYS LABS LTD~750MG~A~078420~002~~Sep 24,
NABUMETONE~TABLET;ORAL~NABUMETONE~INVAGEN PHARMS~500MG~A~078671~001~AB~Mar 7, 20
NABUMETONE~TABLET;ORAL~NABUMETONE~INVAGEN PHARMS~750MG~A~078671~002~AB~Mar 7, 20
NABUMETONE~TABLET;ORAL~NABUMETONE~LUPIN LTD~500MG~A~090445~001~AB~Jan 12, 2011~N
o~RX~LUPIN LTD
NABUMETONE~TABLET;ORAL~NABUMETONE~LUPIN LTD~750MG~A~090445~002~AB~Jan 12, 2011~N
o~RX~LUPIN LTD
NABUMETONE~TABLET;ORAL~NABUMETONE~MYLAN PHARMS INC~500MG~A~090516~001~AB~Jul 12,
NABUMETONE~TABLET;ORAL~NABUMETONE~MYLAN PHARMS INC~750MG~A~090516~002~AB~Jul 12,
NABUMETONE~TABLET;ORAL~NABUMETONE~PAR PHARM~500MG~A~076009~001~AB~Jan 24, 2003~N
o~RX~PAR PHARMACEUTICAL
NABUMETONE~TABLET;ORAL~NABUMETONE~PAR PHARM~750MG~A~076009~002~AB~Jan 24, 2003~N
o~RX~PAR PHARMACEUTICAL
NABUMETONE~TABLET;ORAL~NABUMETONE~PROSAM LABS~500MG~A~079093~001~~Feb 27, 2009~N
o~DISCN~PROSAM LABS LLC
NABUMETONE~TABLET;ORAL~NABUMETONE~PROSAM LABS~750MG~A~079093~002~~Feb 27, 2009~N
o~DISCN~PROSAM LABS LLC
NABUMETONE~TABLET;ORAL~NABUMETONE~SANDOZ~500MG~A~075280~001~AB~Feb 25, 2002~No~R
X~SANDOZ INC
NABUMETONE~TABLET;ORAL~NABUMETONE~SANDOZ~500MG~A~075590~001~~Feb 25, 2002~No~DIS
CN~SANDOZ INC
NABUMETONE~TABLET;ORAL~NABUMETONE~SANDOZ~750MG~A~075280~002~AB~Feb 25, 2002~No~R
X~SANDOZ INC
NABUMETONE~TABLET;ORAL~NABUMETONE~SANDOZ~750MG~A~075590~002~~Feb 25, 2002~No~DIS
CN~SANDOZ INC
NABUMETONE~TABLET;ORAL~NABUMETONE~TEVA~500MG~A~075189~001~AB~May 26, 2000~No~RX~
NABUMETONE~TABLET;ORAL~NABUMETONE~TEVA~750MG~A~075189~002~AB~Sep 24, 2001~Yes~RX
NABUMETONE~TABLET;ORAL~NABUMETONE~WATSON LABS~500MG~A~091083~001~AB~Jun 13, 2011
NABUMETONE~TABLET;ORAL~NABUMETONE~WATSON LABS~750MG~A~091083~002~AB~Jun 13, 2011
NADOLOL~TABLET;ORAL~NADOLOL~IVAX SUB TEVA PHARMS~20MG~A~074229~001~AB~Aug 30, 19
NADOLOL~TABLET;ORAL~NADOLOL~IVAX SUB TEVA PHARMS~40MG~A~074229~002~AB~Aug 30, 19
NADOLOL~TABLET;ORAL~NADOLOL~IVAX SUB TEVA PHARMS~80MG~A~074255~001~AB~Jan 24, 19
NADOLOL~TABLET;ORAL~NADOLOL~IVAX SUB TEVA PHARMS~120MG~A~074255~002~~Jan 24, 199
NADOLOL~TABLET;ORAL~NADOLOL~IVAX SUB TEVA PHARMS~160MG~A~074255~003~~Jan 24, 199
NADOLOL~TABLET;ORAL~NADOLOL~MYLAN~20MG~A~074172~001~AB~Oct 31, 1993~No~RX~MYLAN
PHARMACEUTICALS INC
PHARMACEUTICALS INC
PHARMACEUTICALS INC
NADOLOL~TABLET;ORAL~NADOLOL~SANDOZ~20MG~A~074501~001~AB~Nov 9, 1995~No~RX~SANDOZ
INC
INC
INC
NADOLOL~TABLET;ORAL~NADOLOL~TEVA PHARMS~80MG~A~074368~001~~Aug 31, 1994~No~DISCN
NADOLOL~TABLET;ORAL~NADOLOL~TEVA PHARMS~120MG~A~074368~002~~Aug 31, 1994~No~DISC
N~TEVA PHARMACEUTICALS USA
NADOLOL~TABLET;ORAL~NADOLOL~TEVA PHARMS~160MG~A~074368~003~~Aug 31, 1994~No~DISC
N~TEVA PHARMACEUTICALS USA
BENDROFLUMETHIAZIDE; NADOLOL~TABLET;ORAL~NADOLOL AND BENDROFLUMETHIAZIDE~IMPAX L
ABS~5MG;40MG~A~077833~001~AB~Mar 30, 2007~No~RX~IMPAX LABORATORIES INC
BENDROFLUMETHIAZIDE; NADOLOL~TABLET;ORAL~NADOLOL AND BENDROFLUMETHIAZIDE~IMPAX L
ABS~5MG;80MG~A~077833~002~AB~Mar 30, 2007~No~RX~IMPAX LABORATORIES INC
BENDROFLUMETHIAZIDE; NADOLOL~TABLET;ORAL~NADOLOL AND BENDROFLUMETHIAZIDE~MYLAN~5
MG;40MG~A~078688~001~AB~Feb 15, 2008~No~RX~MYLAN PHARMACEUTICALS INC
BENDROFLUMETHIAZIDE; NADOLOL~TABLET;ORAL~NADOLOL AND BENDROFLUMETHIAZIDE~MYLAN~5
MG;80MG~A~078688~002~AB~Feb 15, 2008~No~RX~MYLAN PHARMACEUTICALS INC
FENOPROFEN CALCIUM~TABLET;ORAL~NALFON~DISTA~EQ 600MG BASE~N~017710~001~~Approved
Prior to Jan 1, 1982~No~DISCN~DISTA PRODUCTS CO DIV ELI LILLY AND CO
NALIDIXIC ACID~TABLET;ORAL~NALIDIXIC ACID~MUTUAL PHARM~1GM~A~070272~001~~Jun 29,
NALIDIXIC ACID~TABLET;ORAL~NALIDIXIC ACID~MUTUAL PHARM~250MG~A~070270~001~~Jun 2
NALIDIXIC ACID~TABLET;ORAL~NALIDIXIC ACID~MUTUAL PHARM~500MG~A~070271~001~~Jun 2
NALIDIXIC ACID~TABLET;ORAL~NALIDIXIC ACID~WATSON LABS~1GM~A~071919~001~~Jun 29,
NALIDIXIC ACID~TABLET;ORAL~NALIDIXIC ACID~WATSON LABS~250MG~A~071936~001~~Jun 29
NALIDIXIC ACID~TABLET;ORAL~NALIDIXIC ACID~WATSON LABS~500MG~A~072061~001~~Jun 29
NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE~TABLET;ORAL~NALOXONE HYDROCHLO
RIDE AND PENTAZOCINE HYDROCHLORIDE~GAVIS PHARMS~EQ 0.5MG BASE;EQ 50MG BASE~A~075
735~001~AB~Jul 11, 2001~No~RX~GAVIS PHARMACEUTICALS LLC
RIDE AND PENTAZOCINE HYDROCHLORIDE~RANBAXY~EQ 0.5MG BASE;EQ 50MG BASE~A~075523~0
01~AB~Mar 17, 2000~No~RX~RANBAXY PHARMACEUTICALS INC
RIDE AND PENTAZOCINE HYDROCHLORIDE~WATSON LABS~EQ 0.5MG BASE;EQ 50MG BASE~A~0747
36~001~AB~Jan 21, 1997~Yes~RX~WATSON LABORATORIES INC
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~NALTREXONE HYDROCHLORIDE~ACCORD HLTHCARE~50
MG~A~091205~001~AB~Aug 17, 2011~No~RX~ACCORD HEALTHCARE INC
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~NALTREXONE HYDROCHLORIDE~BARR~50MG~A~074918
~001~AB~May 8, 1998~No~RX~BARR LABORATORIES INC
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~NALTREXONE HYDROCHLORIDE~ELITE LABS~50MG~A~
075274~001~AB~May 26, 1999~No~RX~ELITE LABORATORIES INC
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~NALTREXONE HYDROCHLORIDE~MALLINCKRODT~25MG~
A~076264~001~~Mar 22, 2002~No~RX~MALLINCKRODT INC
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~NALTREXONE HYDROCHLORIDE~MALLINCKRODT~50MG~
A~076264~002~AB~Mar 22, 2002~No~RX~MALLINCKRODT INC
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~NALTREXONE HYDROCHLORIDE~MALLINCKRODT~100MG
~A~076264~003~~Mar 22, 2002~No~RX~MALLINCKRODT INC
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~NALTREXONE HYDROCHLORIDE~SANDOZ~50MG~A~0754
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~NALTREXONE HYDROCHLORIDE~SUN PHARMA GLOBAL~
50MG~A~090356~001~AB~Feb 24, 2012~No~RX~SUN PHARMA GLOBAL FZE
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~NAMENDA~FOREST LABS~5MG~N~021487~001~AB~Oct
16, 2003~No~RX~FOREST LABORATORIES INC
MEMANTINE HYDROCHLORIDE~TABLET;ORAL~NAMENDA~FOREST LABS~10MG~N~021487~002~AB~Oct

NAPROXEN~TABLET;ORAL~NAPROSYN~ROCHE PALO~250MG~N~017581~002~AB~Approved Prior to
Jan 1, 1982~No~RX~ROCHE PALO ALTO LLC
NAPROXEN~TABLET;ORAL~NAPROSYN~ROCHE PALO~375MG~N~017581~003~AB~Approved Prior to
Jan 1, 1982~No~RX~ROCHE PALO ALTO LLC
NAPROXEN~TABLET;ORAL~NAPROSYN~ROCHE PALO~500MG~N~017581~004~AB~Apr 15, 1982~Yes~
RX~ROCHE PALO ALTO LLC
NAPROXEN~TABLET;ORAL~NAPROXEN~AMNEAL PHARMS NY~250MG~A~075927~001~AB~Dec 18, 200
NAPROXEN~TABLET;ORAL~NAPROXEN~AUROBINDO PHARMA USA~250MG~A~200429~001~AB~Nov 8,
NAPROXEN~TABLET;ORAL~NAPROXEN~DAVA PHARMS INC~250MG~A~074105~001~~Dec 21, 1993~N
NAPROXEN~TABLET;ORAL~NAPROXEN~DAVA PHARMS INC~250MG~A~074410~001~~Apr 28, 1995~N
NAPROXEN~TABLET;ORAL~NAPROXEN~GLENMARK GENERICS~250MG~A~078250~001~AB~Mar 28, 20
NAPROXEN~TABLET;ORAL~NAPROXEN~HAMILTON PHARMS~250MG~A~074110~001~~Oct 30, 1992~N
o~DISCN~HAMILTON PHARMACEUTICALS LTD
NAPROXEN~TABLET;ORAL~NAPROXEN~HIKMA INTL PHARMS~250MG~A~076494~001~AB~Jan 14, 20
NAPROXEN~TABLET;ORAL~NAPROXEN~INVAGEN PHARMS~250MG~A~091305~001~AB~Aug 24, 2011~
NAPROXEN~TABLET;ORAL~NAPROXEN~IVAX SUB TEVA PHARMS~250MG~A~074111~001~~Feb 28, 1

NAPROXEN~TABLET;ORAL~NAPROXEN~MARKSANS PHARMA~250MG~A~091416~001~AB~Feb 14, 2011
~No~RX~MARKSANS PHARMA LTD
NAPROXEN~TABLET;ORAL~NAPROXEN~MYLAN~250MG~A~074121~001~AB~Dec 21, 1993~No~RX~MYL
NAPROXEN~TABLET;ORAL~NAPROXEN~PERRIGO R AND D~250MG~A~077339~001~AB~Apr 27, 2005
~No~RX~PERRIGO R AND D CO
NAPROXEN~TABLET;ORAL~NAPROXEN~PLIVA~250MG~A~074182~001~~Jun 27, 1996~No~DISCN~PL
IVA INC
IVA INC
IVA INC
NAPROXEN~TABLET;ORAL~NAPROXEN~PUREPAC PHARM~250MG~A~074263~001~~Dec 21, 1993~No~
DISCN~PUREPAC PHARMACEUTICAL CO
NAPROXEN~TABLET;ORAL~NAPROXEN~ROXANE~250MG~A~074211~001~~Feb 28, 1994~No~DISCN~R
NAPROXEN~TABLET;ORAL~NAPROXEN~SANDOZ~250MG~A~074140~001~AB~Dec 21, 1993~No~RX~SA
NDOZ INC
NDOZ INC
NDOZ INC
NAPROXEN~TABLET;ORAL~NAPROXEN~TEVA~250MG~A~074129~001~~Dec 21, 1993~No~DISCN~TEV
NAPROXEN~TABLET;ORAL~NAPROXEN~TEVA~250MG~A~074201~001~AB~Dec 21, 1993~No~RX~TEVA
NAPROXEN~TABLET;ORAL~NAPROXEN~TEVA~250MG~A~074216~001~~Apr 11, 1996~No~DISCN~TEV

NAPROXEN~TABLET;ORAL~NAPROXEN~TEVA PHARMS~250MG~A~074207~001~~Dec 21, 1993~No~DI
NAPROXEN~TABLET;ORAL~NAPROXEN~WATSON LABS~250MG~A~074163~001~~Feb 10, 1995~No~DI
NAPROXEN~TABLET;ORAL~NAPROXEN~WATSON LABS~250MG~A~074457~001~~May 31, 1995~No~DI
NAPROXEN~TABLET;ORAL~NAPROXEN~ZYDUS PHARMS USA~250MG~A~078620~001~AB~Jun 7, 2007
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~ABLE~EQ 250MG BASE~A~076544~001~~Aug
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~ABLE~EQ 500MG BASE~A~076544~002~~Aug
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~AMNEAL PHARMS NY~EQ 200MG BASE~A~079
096~001~~Dec 16, 2008~No~OTC~AMNEAL PHARMACEUTICALS NY LLC
432~001~AB~Apr 25, 2007~No~RX~AMNEAL PHARMACEUTICALS NY LLC
432~002~AB~Apr 25, 2007~No~RX~AMNEAL PHARMACEUTICALS NY LLC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~AUROBINDO PHARMA LTD~EQ 250MG BASE~A
~200629~001~AB~Oct 31, 2011~No~RX~AUROBINDO PHARMA LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~AUROBINDO PHARMA LTD~EQ 500MG BASE~A
~200629~002~AB~Oct 31, 2011~No~RX~AUROBINDO PHARMA LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~CONTRACT PHARMACAL~EQ 200MG BASE~A~0
74635~001~~Jan 13, 1997~No~OTC~CONTRACT PHARMACAL CORP
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~CONTRACT PHARMACAL~EQ 200MG BASE~A~0
74789~001~~Feb 27, 1997~No~OTC~CONTRACT PHARMACAL CORP
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~DR REDDYS LABS INC~EQ 200MG BASE~A~0
75168~001~~Jul 28, 1998~No~OTC~DR REDDYS LABORATORIES INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~DR REDDYS LABS LTD~EQ 250MG BASE~A~0
78486~001~AB~Jul 26, 2007~No~RX~DR REDDYS LABORATORIES LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~DR REDDYS LABS LTD~EQ 500MG BASE~A~0
78486~002~AB~Jul 26, 2007~No~RX~DR REDDYS LABORATORIES LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~GLENMARK GENERICS~EQ 250MG BASE~A~07
8314~001~AB~Apr 27, 2007~No~RX~GLENMARK GENERICS LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~GLENMARK GENERICS~EQ 500MG BASE~A~07
8314~002~AB~Apr 27, 2007~No~RX~GLENMARK GENERICS LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~GRANULES INDIA~EQ 200MG BASE~A~09135
3~001~~Sep 20, 2011~No~OTC~GRANULES INDIA LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~HAMILTON PHARMS~EQ 250MG BASE~A~0741
06~001~~Aug 31, 1993~No~DISCN~HAMILTON PHARMACEUTICALS LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~HAMILTON PHARMS~EQ 500MG BASE~A~0741
06~002~~Aug 31, 1993~No~DISCN~HAMILTON PHARMACEUTICALS LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~HIKMA~EQ 250MG BASE~A~074480~002~AB~

Feb 18, 1998~No~RX~HIKMA PHARMACEUTICALS
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~HIKMA~EQ 500MG BASE~A~074480~001~AB~
May 14, 1996~No~RX~HIKMA PHARMACEUTICALS
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~IVAX SUB TEVA PHARMS~EQ 250MG BASE~A
CALS USA
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~IVAX SUB TEVA PHARMS~EQ 500MG BASE~A
CALS USA
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~MARKSANS PHARMA~EQ 200MG BASE~A~0905
45~001~~Mar 16, 2011~No~OTC~MARKSANS PHARMA LTD
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~MYLAN~EQ 250MG BASE~A~074367~001~~Au
g 31, 1994~No~DISCN~MYLAN PHARMACEUTICALS INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~MYLAN~EQ 500MG BASE~A~074367~002~~Au
g 31, 1994~No~DISCN~MYLAN PHARMACEUTICALS INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~PERRIGO~EQ 200MG BASE~A~074661~001~~
Jan 13, 1997~No~OTC~L PERRIGO CO
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~PLIVA~EQ 250MG BASE~A~074242~001~~Ju
n 20, 1996~No~DISCN~PLIVA INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~PLIVA~EQ 500MG BASE~A~074242~002~~Ju
n 20, 1996~No~DISCN~PLIVA INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~PUREPAC PHARM~EQ 250MG BASE~A~074319
~001~~Mar 20, 1995~No~DISCN~PUREPAC PHARMACEUTICAL CO
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~PUREPAC PHARM~EQ 500MG BASE~A~074319
~002~~Mar 20, 1995~No~DISCN~PUREPAC PHARMACEUTICAL CO
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~RANBAXY LABS LTD~EQ 200MG BASE~A~091
183~001~~May 20, 2011~No~OTC~RANBAXY LABORATORIES LIMITED
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~ROXANE~EQ 250MG BASE~A~074257~001~~D
ec 21, 1993~No~DISCN~ROXANE LABORATORIES INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~ROXANE~EQ 500MG BASE~A~074257~002~~D
ec 21, 1993~No~DISCN~ROXANE LABORATORIES INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~SANDOZ~EQ 200MG BASE~A~074646~001~~J
an 13, 1997~No~DISCN~SANDOZ INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~SANDOZ~EQ 250MG BASE~A~074162~001~~D
ec 21, 1993~No~DISCN~SANDOZ INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~TEVA~EQ 250MG BASE~A~074142~001~~Dec
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~TEVA~EQ 250MG BASE~A~074198~001~AB~D
ec 21, 1993~No~RX~TEVA PHARMACEUTICALS USA INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~TEVA~EQ 500MG BASE~A~074142~002~~Dec
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~TEVA~EQ 500MG BASE~A~074198~002~AB~D
ec 21, 1993~No~RX~TEVA PHARMACEUTICALS USA INC
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~TEVA PHARMS~EQ 250MG BASE~A~074289~0
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~TEVA PHARMS~EQ 500MG BASE~A~074289~0
NAPROXEN SODIUM~TABLET;ORAL~NAPROXEN SODIUM~WATSON LABS~EQ 250MG BASE~A~074195~0
01~~Dec 21, 1993~No~DISCN~WATSON LABORATORIES INC
01~~May 31, 1995~No~DISCN~WATSON LABORATORIES INC
02~~Dec 21, 1993~No~DISCN~WATSON LABORATORIES INC

02~~May 31, 1995~No~DISCN~WATSON LABORATORIES INC
TRICHLORMETHIAZIDE~TABLET;ORAL~NAQUA~SCHERING~2MG~N~012265~001~~Approved Prior t
TRICHLORMETHIAZIDE~TABLET;ORAL~NAQUA~SCHERING~4MG~N~012265~002~~Approved Prior t
RESERPINE; TRICHLORMETHIAZIDE~TABLET;ORAL~NAQUIVAL~SCHERING~0.1MG;4MG~N~012265~0
03~~Approved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH COR
P
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~APOTEX CORP~EQ 1MG BASE~A~0913
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~APOTEX CORP~EQ 2.5MG BASE~A~09
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~HERITAGE PHARMS INC~EQ 1MG BAS
E~A~200502~001~AB~Feb 28, 2011~No~RX~HERITAGE PHARMACEUTICALS INC
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~HERITAGE PHARMS INC~EQ 2.5MG B
ASE~A~200502~002~AB~Feb 28, 2011~No~RX~HERITAGE PHARMACEUTICALS INC
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~MYLAN PHARMS INC~EQ 1MG BASE~A
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~MYLAN PHARMS INC~EQ 2.5MG BASE
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~ORCHID HLTHCARE~EQ 1MG BASE~A~
091441~001~AB~Apr 30, 2012~No~RX~ORCHID HEALTHCARE
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~ORCHID HLTHCARE~EQ 2.5MG BASE~
A~091441~002~AB~Apr 30, 2012~No~RX~ORCHID HEALTHCARE
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~PADDOCK LLC~EQ 1MG BASE~A~0913
26~001~AB~Jul 8, 2010~No~RX~PADDOCK LABORATORIES LLC
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~PADDOCK LLC~EQ 2.5MG BASE~A~09
1326~002~AB~Jul 8, 2010~No~RX~PADDOCK LABORATORIES LLC
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~ROXANE~EQ 1MG BASE~A~090381~00
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~ROXANE~EQ 2.5MG BASE~A~090381~
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~SANDOZ~EQ 1MG BASE~A~090288~00
1~AB~Jul 7, 2010~No~RX~SANDOZ INC
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~SANDOZ~EQ 2.5MG BASE~A~090288~
002~AB~Jul 7, 2010~No~RX~SANDOZ INC
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~SUN PHARM INDS LTD~EQ 2.5MG BA
SE~A~091552~001~AB~Feb 14, 2011~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~TEVA PHARMS~EQ 1MG BASE~A~0787
51~001~AB~Jul 7, 2010~No~RX~TEVA PHARMACEUTICALS USA
NARATRIPTAN HYDROCHLORIDE~TABLET;ORAL~NARATRIPTAN~TEVA PHARMS~EQ 2.5MG BASE~A~07
8751~002~AB~Jul 7, 2010~No~RX~TEVA PHARMACEUTICALS USA
PHENELZINE SULFATE~TABLET;ORAL~NARDIL~PARKE DAVIS~EQ 15MG BASE~N~011909~002~AB~A
pproved Prior to Jan 1, 1982~Yes~RX~PARKE DAVIS DIV WARNER LAMBERT CO
DIENOGEST; ESTRADIOL VALERATE~TABLET;ORAL~NATAZIA~BAYER HLTHCARE~N/A,2MG,3MG,N/A
,N/A;3MG,2MG,2MG,1MG,N/A~N~022252~001~~May 6, 2010~Yes~RX~BAYER HEALTHCARE PHARM
ACEUTICALS INC
NATEGLINIDE~TABLET;ORAL~NATEGLINIDE~DR REDDYS LABS LTD~60MG~A~077461~001~AB~Sep
NATEGLINIDE~TABLET;ORAL~NATEGLINIDE~DR REDDYS LABS LTD~120MG~A~077461~002~AB~Sep
NATEGLINIDE~TABLET;ORAL~NATEGLINIDE~PAR PHARM~60MG~A~077463~001~AB~Sep 9, 2009~N
o~RX~PAR PHARMACEUTICAL INC
NATEGLINIDE~TABLET;ORAL~NATEGLINIDE~PAR PHARM~120MG~A~077463~002~AB~Sep 9, 2009~
No~RX~PAR PHARMACEUTICAL INC
NATEGLINIDE~TABLET;ORAL~NATEGLINIDE~TEVA PHARMS~60MG~A~077467~001~~Sep 9, 2009~N
o~DISCN~TEVA PHARMACEUTICALS USA
NATEGLINIDE~TABLET;ORAL~NATEGLINIDE~TEVA PHARMS~120MG~A~077467~002~~Sep 9, 2009~
No~DISCN~TEVA PHARMACEUTICALS USA
NATEGLINIDE~TABLET;ORAL~NATEGLINIDE~WATSON LABS~60MG~A~077462~001~AB~Mar 30, 201

NATEGLINIDE~TABLET;ORAL~NATEGLINIDE~WATSON LABS~120MG~A~077462~002~AB~Mar 30, 20
BENDROFLUMETHIAZIDE~TABLET;ORAL~NATURETIN-10~APOTHECON~10MG~N~012164~003~~Approv
BENDROFLUMETHIAZIDE~TABLET;ORAL~NATURETIN-2.5~APOTHECON~2.5MG~N~012164~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
BENDROFLUMETHIAZIDE~TABLET;ORAL~NATURETIN-5~APOTHECON~5MG~N~012164~002~~Approved
Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~NEFAZODONE HYDROCHLORIDE~DR REDDYS LABS INC
~50MG~A~076309~001~BX~Sep 16, 2003~No~RX~DR REDDYS LABORATORIES INC
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~NEFAZODONE HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~50MG~A~075763~001~~Sep 16, 2003~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PH
ARMACEUTICALS USA
MS~100MG~A~075763~002~~Sep 16, 2003~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA P
HARMACEUTICALS USA
HARMACEUTICALS USA
HARMACEUTICALS USA
HARMACEUTICALS USA
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~NEFAZODONE HYDROCHLORIDE~MYLAN~100MG~A~0761
29~002~~Sep 16, 2003~No~DISCN~MYLAN PHARMACEUTICALS INC
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~NEFAZODONE HYDROCHLORIDE~RANBAXY~50MG~A~076
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~NEFAZODONE HYDROCHLORIDE~ROXANE~50MG~A~0761
96~001~~Sep 16, 2003~No~DISCN~ROXANE LABORATORIES INC

NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~NEFAZODONE HYDROCHLORIDE~SANDOZ~50MG~A~0760
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~NEFAZODONE HYDROCHLORIDE~TEVA~50MG~A~076037
~001~AB~Sep 16, 2003~No~RX~TEVA PHARMACEUTICALS USA INC
7~005~AB~Sep 16, 2003~Yes~RX~TEVA PHARMACEUTICALS USA INC
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~NEFAZODONE HYDROCHLORIDE~WATSON LABS~100MG~
A~076073~002~~Sep 16, 2003~No~DISCN~WATSON LABORATORIES INC
NALIDIXIC ACID~TABLET;ORAL~NEGGRAM~SANOFI AVENTIS US~1GM~N~014214~005~~Approved
NALIDIXIC ACID~TABLET;ORAL~NEGGRAM~SANOFI AVENTIS US~250MG~N~014214~002~~Approve
NALIDIXIC ACID~TABLET;ORAL~NEGGRAM~SANOFI AVENTIS US~500MG~N~014214~004~~Approve
NEOMYCIN SULFATE~TABLET;ORAL~NEOBIOTIC~PFIZER~EQ 350MG BASE~A~060475~001~~Approv
NEOMYCIN SULFATE~TABLET;ORAL~NEOMYCIN SULFATE~BRISTOL MYERS SQUIBB~500MG~A~06036
NEOMYCIN SULFATE~TABLET;ORAL~NEOMYCIN SULFATE~LANNETT~500MG~A~060607~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
NEOMYCIN SULFATE~TABLET;ORAL~NEOMYCIN SULFATE~LILLY~500MG~A~060385~001~~Approved
NEOMYCIN SULFATE~TABLET;ORAL~NEOMYCIN SULFATE~OMAN PHARM PRODUCTS~500MG~A~065468
~001~AA~Mar 29, 2010~No~RX~OMAN PHARMACEUTICAL PRODUCTS CO LLC
NEOMYCIN SULFATE~TABLET;ORAL~NEOMYCIN SULFATE~ROXANE~500MG~A~062173~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
NEOMYCIN SULFATE~TABLET;ORAL~NEOMYCIN SULFATE~SANDOZ~500MG~A~061586~001~~Approve

NEOMYCIN SULFATE~TABLET;ORAL~NEOMYCIN SULFATE~TEVA~500MG~A~060304~001~AA~Approve
d Prior to Jan 1, 1982~Yes~RX~TEVA PHARMACEUTICALS USA INC
NEOMYCIN SULFATE~TABLET;ORAL~NEOMYCIN SULFATE~X GEN PHARMS~500MG~A~065220~001~AA
~Jul 28, 2006~No~RX~X GEN PHARMACEUTICALS INC
AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID~TABLET;ORAL~NEOPASALATE~MEDPOINTE PH
ARM HLC~846MG;112MG~A~080059~002~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOIN
TE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
DYPHYLLINE~TABLET;ORAL~NEOTHYLLINE~TEVA~200MG~N~007794~001~~Approved Prior to Ja
DYPHYLLINE~TABLET;ORAL~NEOTHYLLINE~TEVA~400MG~N~007794~002~~Approved Prior to Ja
TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)~TABLET;ORAL~NEOT
RIZINE~LILLY~167MG;167MG;167MG~N~006317~011~~Approved Prior to Jan 1, 1982~No~DI
SCN~ELI LILLY AND CO
METHAZOLAMIDE~TABLET;ORAL~NEPTAZANE~LEDERLE~25MG~N~011721~002~~Nov 25, 1991~No~D
METHAZOLAMIDE~TABLET;ORAL~NEPTAZANE~LEDERLE~50MG~N~011721~001~~Approved Prior to
ALOGLIPTIN BENZOATE~TABLET;ORAL~NESINA~TAKEDA PHARMS USA~EQ 6.25MG BASE~N~022271
~001~~Jan 25, 2013~No~RX~TAKEDA PHARMACEUTICALS USA INC
ALOGLIPTIN BENZOATE~TABLET;ORAL~NESINA~TAKEDA PHARMS USA~EQ 12.5MG BASE~N~022271
~002~~Jan 25, 2013~No~RX~TAKEDA PHARMACEUTICALS USA INC
ALOGLIPTIN BENZOATE~TABLET;ORAL~NESINA~TAKEDA PHARMS USA~EQ 25MG BASE~N~022271~0
03~~Jan 25, 2013~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
MEPROBAMATE~TABLET;ORAL~NEURAMATE~HALSEY~200MG~N~014359~002~~Approved Prior to J
an 1, 1982~No~DISCN~HALSEY DRUG CO INC
MEPROBAMATE~TABLET;ORAL~NEURAMATE~HALSEY~400MG~N~014359~001~~Approved Prior to J
an 1, 1982~No~DISCN~HALSEY DRUG CO INC
GABAPENTIN~TABLET;ORAL~NEURONTIN~PFIZER PHARMS~600MG~N~020882~001~AB~Oct 9, 1998
~No~RX~PFIZER PHARMACEUTICALS LTD
GABAPENTIN~TABLET;ORAL~NEURONTIN~PFIZER PHARMS~800MG~N~020882~002~AB~Oct 9, 1998
~Yes~RX~PFIZER PHARMACEUTICALS LTD
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~APOTEX INC~200MG~A~203021~001~AB~May 22, 2012~
No~RX~APOTEX INC
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~AUROBINDO~200MG~A~077521~001~AB~May 22, 2012~N
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~CIPLA~200MG~A~077956~001~AB~May 22, 2012~No~RX
~CIPLA LTD
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~HETERO LABS LTD III~200MG~A~078584~001~AB~May
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~MICRO LABS LTD~200MG~A~203080~001~AB~May 22, 2
012~No~RX~MICRO LABS LTD
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~MYLAN LABS~200MG~A~078864~001~AB~May 22, 2012~
No~RX~MYLAN LABORATORIES LTD
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~MYLAN PHARMS INC~200MG~A~202523~001~AB~May 22,
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~PRINSTON INC~200MG~A~078644~001~AB~May 22, 201
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~SCIEGEN PHARMS INC~200MG~A~203176~001~AB~May 2
2, 2012~No~RX~SCIEGEN PHARMACEUTICALS INC
NEVIRAPINE~TABLET;ORAL~NEVIRAPINE~STRIDES PHARMA~200MG~A~078195~001~AB~May 22, 2
SORAFENIB TOSYLATE~TABLET;ORAL~NEXAVAR~BAYER HLTHCARE~EQ 200MG BASE~N~021923~001
~~Dec 20, 2005~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
NIACIN~TABLET;ORAL~NIACIN~EVERYLIFE~500MG~A~083203~001~~Approved Prior to Jan 1,
1982~No~DISCN~EVERYLIFE
NIACIN~TABLET;ORAL~NIACIN~HALSEY~500MG~A~083453~001~~Approved Prior to Jan 1, 19
NIACIN~TABLET;ORAL~NIACIN~HIKMA PHARMS LLC~500MG~A~083718~001~~Approved Prior to
Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTICALS LLC

NIACIN~TABLET;ORAL~NIACIN~IMPAX LABS~500MG~A~083115~001~~Approved Prior to Jan 1
, 1982~No~DISCN~IMPAX LABORATORIES INC
NIACIN~TABLET;ORAL~NIACIN~IVAX SUB TEVA PHARMS~500MG~A~083180~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
NIACIN~TABLET;ORAL~NIACIN~MK LABS~500MG~A~083525~001~~Approved Prior to Jan 1, 1
982~No~DISCN~MK LABORATORIES INC
NIACIN~TABLET;ORAL~NIACIN~PUREPAC PHARM~500MG~A~083271~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
NIACIN~TABLET;ORAL~NIACIN~SANDOZ~500MG~A~083306~001~~Approved Prior to Jan 1, 19
NIACIN~TABLET;ORAL~NIACIN~TABLICAPS~500MG~A~084237~001~~Approved Prior to Jan 1,
1982~No~DISCN~TABLICAPS INC
NIACIN~TABLET;ORAL~NIACIN~WATSON LABS~500MG~A~083136~001~~Approved Prior to Jan
NIACIN~TABLET;ORAL~NIACIN~WOCKHARDT~500MG~A~081134~001~AA~Apr 28, 1992~No~RX~WOC
KHARDT LTD
NIACIN~TABLET;ORAL~NIACOR~UPSHER SMITH~500MG~A~040378~001~AA~May 3, 2000~Yes~RX~
UPSHER SMITH LABORATORIES INC
NIACIN~TABLET;ORAL~NICOLAR~SANOFI AVENTIS US~500MG~A~083823~001~~Approved Prior
to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL~NIKKI~LUPIN LTD~3MG;0.02MG~A~201661~
001~AB~May 27, 2014~No~RX~LUPIN LTD
NILUTAMIDE~TABLET;ORAL~NILANDRON~COVIS PHARMA SARL~50MG~N~020169~001~~Sep 19, 19
96~No~DISCN~COVIS PHARMA SARL
NILUTAMIDE~TABLET;ORAL~NILANDRON~COVIS PHARMA SARL~150MG~N~020169~002~~Apr 30, 1
999~Yes~RX~COVIS PHARMA SARL
NYSTATIN~TABLET;ORAL~NILSTAT~LEDERLE~500,000 UNITS~A~061151~001~~Approved Prior
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~ELKINS SINN~50MG~A~080003~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~ELKINS SINN~100MG~A~080003~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~IVAX SUB TEVA PHARMS~50MG~A~080078~002
~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~IVAX SUB TEVA PHARMS~100MG~A~080078~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHAR
MACEUTICALS USA
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~SANDOZ~50MG~A~080043~001~~Approved Pri
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~SANDOZ~100MG~A~080043~002~~Approved Pr
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~WATSON LABS~50MG~A~080447~001~~Approve
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~WATSON LABS~50MG~A~085797~001~~Approve
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~WATSON LABS~100MG~A~080447~002~~Approv
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~WATSON LABS~100MG~A~085796~001~~Approv
NITROFURANTOIN~TABLET;ORAL~NITROFURANTOIN~WHITEWORTH TOWN PLSN~100MG~A~084085~00
2~~Approved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
KETOCONAZOLE~TABLET;ORAL~NIZORAL~JANSSEN PHARMS~200MG~N~018533~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~JANSSEN PHARMACEUTICALS INC
METHYPRYLON~TABLET;ORAL~NOLUDAR~ROCHE~50MG~N~009660~002~~Approved Prior to Jan 1

METHYPRYLON~TABLET;ORAL~NOLUDAR~ROCHE~200MG~N~009660~004~~Approved Prior to Jan
TAMOXIFEN CITRATE~TABLET;ORAL~NOLVADEX~ASTRAZENECA~EQ 10MG BASE~N~017970~001~~Ap
TAMOXIFEN CITRATE~TABLET;ORAL~NOLVADEX~ASTRAZENECA~EQ 20MG BASE~N~017970~002~~Ma
r 21, 1994~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~NORCET~ABANA~500MG;5MG~A~08887
1~001~~May 15, 1986~No~DISCN~ABANA PHARMACEUTICALS INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~NORCO~ACTAVIS LABS FL INC~325M
G;2.5MG~A~040148~004~AA~Jul 7, 2014~No~RX~ACTAVIS LABORATORIES FL INC
G;5MG~A~040148~005~AA~Jul 7, 2014~No~RX~ACTAVIS LABORATORIES FL INC
G;7.5MG~A~040148~003~AA~Sep 12, 2000~Yes~RX~ACTAVIS LABORATORIES FL INC
G;10MG~A~040148~001~AA~Feb 14, 1997~Yes~RX~ACTAVIS LABORATORIES FL INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~NORCO~WATSON LABS~325MG;5MG~A~
040099~001~AA~Jun 25, 1997~Yes~RX~WATSON LABORATORIES
NORETHINDRONE ACETATE~TABLET;ORAL~NORETHINDRONE ACETATE~AMNEAL PHARMS~5MG~A~2002
75~001~AB~Jul 30, 2012~No~RX~AMNEAL PHARMACEUTICALS
NORETHINDRONE ACETATE~TABLET;ORAL~NORETHINDRONE ACETATE~BARR~5MG~A~075951~001~AB
~May 25, 2001~No~RX~BARR LABORATORIES INC
NORETHINDRONE ACETATE~TABLET;ORAL~NORETHINDRONE ACETATE~GLENMARK GENERICS~5MG~A~
091090~001~AB~Jul 21, 2010~No~RX~GLENMARK GENERICS LTD INDIA
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL~NORETHINDRONE ACETATE AND E
THINYL ESTRADIOL~BARR LABS INC~0.005MG;1MG~A~076221~001~~Nov 6, 2009~Yes~RX~BARR
LABORATORIES INC
THINYL ESTRADIOL AND FERROUS FUMARATE~AMNEAL PHARMS~0.02MG;1MG~A~078267~001~AB~S
ep 1, 2009~Yes~RX~AMNEAL PHARMACEUTICALS OF NEW YORK LLC
THINYL ESTRADIOL AND FERROUS FUMARATE~BARR LABS INC~0.02MG;1MG~A~090938~001~AB~D
ec 1, 2014~No~RX~BARR LABORATORIES INC
THINYL ESTRADIOL AND FERROUS FUMARATE~FAMY CARE LTD~0.02MG;1MG~A~202742~001~AB~O
ct 30, 2014~No~RX~FAMY CARE LTD
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE~TABLET;ORAL~NORGESIC~MEDICIS~385MG;30MG;
25MG~N~013416~003~AB~Oct 27, 1982~No~RX~MEDICIS PHARMACEUTICAL CORP
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE~TABLET;ORAL~NORGESIC FORTE~MEDICIS~770MG
;60MG;50MG~N~013416~004~AB~Oct 27, 1982~Yes~RX~MEDICIS PHARMACEUTICAL CORP
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL~NORGESTIMATE AND ETHINYL ESTRADIOL~G
LENMARK GENERICS~0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG~A~200494~001~AB~J
un 17, 2011~No~RX~GLENMARK GENERICS LTD
NORETHINDRONE ACETATE~TABLET;ORAL~NORLUTATE~PARKE DAVIS~5MG~N~012184~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
NORETHINDRONE~TABLET;ORAL~NORLUTIN~PARKE DAVIS~5MG~N~010895~002~~Approved Prior
to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
LABETALOL HYDROCHLORIDE~TABLET;ORAL~NORMODYNE~SCHERING~100MG~N~018687~001~~Aug 3
1, 1987~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
, 1984~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE~TABLET;ORAL~NORMOZIDE~SCHERING~25MG
;100MG~N~019046~001~~Apr 6, 1987~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP

NORFLOXACIN~TABLET;ORAL~NOROXIN~MERCK~400MG~N~019384~002~~Oct 31, 1986~No~DISCN~
MERCK RESEARCH LABORATORIES DIV MERCK CO INC
DESIPRAMINE HYDROCHLORIDE~TABLET;ORAL~NORPRAMIN~SANOFI AVENTIS US~10MG~N~014399~
007~AB~Feb 11, 1982~No~RX~SANOFI AVENTIS US LLC
001~AB~Approved Prior to Jan 1, 1982~No~RX~SANOFI AVENTIS US LLC
DESIPRAMINE HYDROCHLORIDE~TABLET;ORAL~NORPRAMIN~SANOFI AVENTIS US~100MG~N~014399
~005~AB~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
DESIPRAMINE HYDROCHLORIDE~TABLET;ORAL~NORPRAMIN~SANOFI AVENTIS US~150MG~N~014399
~006~AB~Approved Prior to Jan 1, 1982~No~RX~SANOFI AVENTIS US LLC
AMLODIPINE BESYLATE~TABLET;ORAL~NORVASC~PFIZER~EQ 2.5MG BASE~N~019787~001~AB~Jul
AMLODIPINE BESYLATE~TABLET;ORAL~NORVASC~PFIZER~EQ 5MG BASE~N~019787~002~AB~Jul 3
AMLODIPINE BESYLATE~TABLET;ORAL~NORVASC~PFIZER~EQ 10MG BASE~N~019787~003~AB~Jul
RITONAVIR~TABLET;ORAL~NORVIR~ABBVIE~100MG~N~022417~001~AB~Feb 10, 2010~Yes~RX~AB
BVIE INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~NOVOTHYROX~MERCK KGAA~0.025MG~N~021292~001~~May
31, 2002~No~DISCN~MERCK KGAA
LEVOTHYROXINE SODIUM~TABLET;ORAL~NOVOTHYROX~MERCK KGAA~0.1MG~N~021292~005~~May 3
TAPENTADOL HYDROCHLORIDE~TABLET;ORAL~NUCYNTA~JANSSEN PHARMS~EQ 50MG BASE~N~02230
4~001~~Nov 20, 2008~No~RX~JANSSEN PHARMACEUTICALS INC
4~002~~Nov 20, 2008~No~RX~JANSSEN PHARMACEUTICALS INC
04~003~~Nov 20, 2008~Yes~RX~JANSSEN PHARMACEUTICALS INC
IBUPROFEN~TABLET;ORAL~NUPRIN~BRISTOL MYERS~200MG~A~072035~001~~Feb 16, 1988~No~D
ISCN~BRISTOL MYERS PRODUCTS INC
IBUPROFEN~TABLET;ORAL~NUPRIN~BRISTOL MYERS~200MG~A~072036~001~~Feb 16, 1988~No~D
ISCN~BRISTOL MYERS PRODUCTS INC
IBUPROFEN~TABLET;ORAL~NUPRIN~MCNEIL~200MG~N~019012~001~~May 18, 1984~No~DISCN~MC

NEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
IBUPROFEN~TABLET;ORAL~NUPRIN~MCNEIL~200MG~N~019012~002~~Jul 29, 1987~No~DISCN~MC
NEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
ARMODAFINIL~TABLET;ORAL~NUVIGIL~CEPHALON~50MG~N~021875~001~~Jun 15, 2007~No~RX~C
EPHALON INC
ARMODAFINIL~TABLET;ORAL~NUVIGIL~CEPHALON~100MG~N~021875~002~~Mar 26, 2009~No~DIS
CN~CEPHALON INC
ARMODAFINIL~TABLET;ORAL~NUVIGIL~CEPHALON~150MG~N~021875~003~~Jun 15, 2007~No~RX~
CEPHALON INC
ARMODAFINIL~TABLET;ORAL~NUVIGIL~CEPHALON~200MG **Federal Register determination
N~021875~005~~Mar 26, 2009~No~RX~CEPHALON INC
ARMODAFINIL~TABLET;ORAL~NUVIGIL~CEPHALON~250MG~N~021875~004~~Jun 15, 2007~Yes~RX
~CEPHALON INC
ISONIAZID~TABLET;ORAL~NYDRAZID~BRISTOL MYERS SQUIBB~100MG~N~008392~003~~Approved
Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
NYSTATIN~TABLET;ORAL~NYSTATIN~HERITAGE PHARMS INC~500,000 UNITS~A~062474~001~AA~
Dec 22, 1983~No~RX~HERITAGE PHARMACEUTICALS INC
NYSTATIN~TABLET;ORAL~NYSTATIN~MUTUAL PHARM~500,000 UNITS~A~062838~001~AA~Dec 22,
NYSTATIN~TABLET;ORAL~NYSTATIN~QUANTUM PHARMICS~500,000 UNITS~A~062525~001~~Oct 2
9, 1984~No~DISCN~QUANTUM PHARMICS LTD
NYSTATIN~TABLET;ORAL~NYSTATIN~SANDOZ~500,000 UNITS~A~062065~001~~Approved Prior
NYSTATIN~TABLET;ORAL~NYSTATIN~TEVA~500,000 UNITS~A~062506~001~AA~Jan 16, 1984~Ye
NYSTATIN~TABLET;ORAL~NYSTATIN~USL PHARMA~500,000 UNITS~A~062524~001~~Nov 26, 198
NYSTATIN~TABLET;ORAL~NYSTATIN~WATSON LABS~500,000 UNITS~A~062402~001~~Dec 16, 19
OFLOXACIN~TABLET;ORAL~OFLOXACIN~CADILA PHARMS LTD~200MG~A~091656~001~AB~Sep 18,
OFLOXACIN~TABLET;ORAL~OFLOXACIN~DR REDDYS LABS LTD~200MG~A~077098~001~AB~Feb 10,
OFLOXACIN~TABLET;ORAL~OFLOXACIN~LARKEN LABS~200MG~A~076093~001~~Sep 2, 2003~No~D
ISCN~LARKEN LABORATORIES INC
OFLOXACIN~TABLET;ORAL~OFLOXACIN~RANBAXY LABS LTD~200MG~A~076220~001~~Sep 2, 2003
~No~DISCN~RANBAXY LABORATORIES LTD
OFLOXACIN~TABLET;ORAL~OFLOXACIN~TEVA~200MG~A~076182~001~AB~Sep 2, 2003~No~RX~TEV
OFLOXACIN~TABLET;ORAL~OFLOXACIN~TEVA~300MG~A~076182~002~AB~Sep 2, 2003~No~RX~TEV
OFLOXACIN~TABLET;ORAL~OFLOXACIN~TEVA~400MG~A~076182~003~AB~Sep 2, 2003~Yes~RX~TE

FLUDARABINE PHOSPHATE~TABLET;ORAL~OFORTA~SANOFI AVENTIS US~10MG~N~022273~001~~De
c 18, 2008~No~DISCN~SANOFI AVENTIS US LLC
ESTROPIPATE~TABLET;ORAL~OGEN .625~PHARMACIA AND UPJOHN~0.75MG~A~083220~001~AB~Ap
proved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
ESTROPIPATE~TABLET;ORAL~OGEN 1.25~PHARMACIA AND UPJOHN~1.5MG~A~083220~002~AB~App
roved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
ESTROPIPATE~TABLET;ORAL~OGEN 2.5~PHARMACIA AND UPJOHN~3MG~A~083220~003~AB~Approv
ed Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
ESTROPIPATE~TABLET;ORAL~OGEN 5~PHARMACIA AND UPJOHN~6MG~A~083220~004~~Approved P
rior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
OLANZAPINE~TABLET;ORAL~OLANZAPINE~APOTEX INC~2.5MG~A~090798~001~AB~Apr 23, 2012~
No~RX~APOTEX INC
OLANZAPINE~TABLET;ORAL~OLANZAPINE~APOTEX INC~5MG~A~090798~002~AB~Apr 23, 2012~No
~RX~APOTEX INC
OLANZAPINE~TABLET;ORAL~OLANZAPINE~APOTEX INC~7.5MG~A~090798~003~AB~Apr 23, 2012~
No~RX~APOTEX INC
OLANZAPINE~TABLET;ORAL~OLANZAPINE~APOTEX INC~10MG~A~090798~004~AB~Apr 23, 2012~N
o~RX~APOTEX INC
o~RX~APOTEX INC
o~RX~APOTEX INC
OLANZAPINE~TABLET;ORAL~OLANZAPINE~AUROBINDO PHARMA LTD~2.5MG~A~202050~001~AB~Apr
OLANZAPINE~TABLET;ORAL~OLANZAPINE~AUROBINDO PHARMA LTD~5MG~A~202050~002~AB~Apr 2
OLANZAPINE~TABLET;ORAL~OLANZAPINE~AUROBINDO PHARMA LTD~7.5MG~A~202050~003~AB~Apr
OLANZAPINE~TABLET;ORAL~OLANZAPINE~AUROBINDO PHARMA LTD~10MG~A~202050~004~AB~Apr
OLANZAPINE~TABLET;ORAL~OLANZAPINE~DR REDDYS LABS LTD~2.5MG~A~076255~001~AB~Apr 2
OLANZAPINE~TABLET;ORAL~OLANZAPINE~DR REDDYS LABS LTD~5MG~A~076255~002~AB~Apr 23,
OLANZAPINE~TABLET;ORAL~OLANZAPINE~DR REDDYS LABS LTD~7.5MG~A~076255~003~AB~Apr 2
OLANZAPINE~TABLET;ORAL~OLANZAPINE~DR REDDYS LABS LTD~10MG~A~076255~004~AB~Apr 23
OLANZAPINE~TABLET;ORAL~OLANZAPINE~DR REDDYS LABS LTD~15MG~A~076133~001~AB~Apr 23
OLANZAPINE~TABLET;ORAL~OLANZAPINE~DR REDDYS LABS LTD~20MG~A~076133~002~AB~Oct 24
OLANZAPINE~TABLET;ORAL~OLANZAPINE~MACLEODS PHARMS LTD~2.5MG~A~202862~001~AB~Aug
OLANZAPINE~TABLET;ORAL~OLANZAPINE~MACLEODS PHARMS LTD~5MG~A~202862~002~AB~Aug 15
, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
OLANZAPINE~TABLET;ORAL~OLANZAPINE~MACLEODS PHARMS LTD~7.5MG~A~202862~003~AB~Aug
OLANZAPINE~TABLET;ORAL~OLANZAPINE~MYLAN~2.5MG~A~076866~001~AB~Apr 23, 2012~No~RX
~MYLAN LABORATORIES INC

OLANZAPINE~TABLET;ORAL~OLANZAPINE~MYLAN~5MG~A~076866~002~AB~Apr 23, 2012~No~RX~M
OLANZAPINE~TABLET;ORAL~OLANZAPINE~MYLAN~7.5MG~A~076866~003~AB~Apr 23, 2012~No~RX
~MYLAN LABORATORIES INC
OLANZAPINE~TABLET;ORAL~OLANZAPINE~MYLAN~10MG~A~076866~004~AB~Apr 23, 2012~No~RX~
OLANZAPINE~TABLET;ORAL~OLANZAPINE~ORCHID HLTHCARE~2.5MG~A~202287~001~AB~Apr 23,
OLANZAPINE~TABLET;ORAL~OLANZAPINE~ORCHID HLTHCARE~5MG~A~202287~002~AB~Apr 23, 20
OLANZAPINE~TABLET;ORAL~OLANZAPINE~ORCHID HLTHCARE~7.5MG~A~202287~003~AB~Apr 23,
OLANZAPINE~TABLET;ORAL~OLANZAPINE~SUN PHARM INDS~2.5MG~A~091038~001~AB~Apr 23, 2
OLANZAPINE~TABLET;ORAL~OLANZAPINE~SUN PHARM INDS~5MG~A~091038~002~AB~Apr 23, 201
OLANZAPINE~TABLET;ORAL~OLANZAPINE~SUN PHARM INDS~7.5MG~A~091038~003~AB~Apr 23, 2
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TEVA PHARMS~2.5MG~A~076000~001~AB~Oct 24, 2011
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TEVA PHARMS~5MG~A~076000~002~AB~Oct 24, 2011~N
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TEVA PHARMS~7.5MG~A~076000~003~AB~Oct 24, 2011
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TEVA PHARMS~10MG~A~076000~004~AB~Oct 24, 2011~
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TEVA PHARMS~15MG~A~076000~005~AB~Oct 24, 2011~
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TORRENT PHARMS LTD~2.5MG~A~091434~001~AB~Apr 2
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TORRENT PHARMS LTD~5MG~A~091434~002~AB~Apr 23,
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TORRENT PHARMS LTD~7.5MG~A~091434~003~AB~Apr 2
OLANZAPINE~TABLET;ORAL~OLANZAPINE~TORRENT PHARMS LTD~10MG~A~091434~004~AB~Apr 23
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~ONA-MAST~MAST MM~8MG~A~086260~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~MM MAST AND CO
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~APOTEX~EQ 4MG BA
SE~A~077306~001~AB~Jun 25, 2007~No~RX~APOTEX INC

ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~APOTEX~EQ 8MG BA
SE~A~077306~002~AB~Jun 25, 2007~No~RX~APOTEX INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~AUROBINDO PHARMA
~EQ 4MG BASE~A~078539~001~AB~Jul 31, 2007~No~RX~AUROBINDO PHARMA LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~DR REDDYS LABS L
TD~EQ 16MG BASE~A~076183~004~~Dec 26, 2006~No~RX~DR REDDYS LABORATORIES LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~GLENMARK GENERIC
S~EQ 4MG BASE~A~077535~001~AB~Jun 25, 2007~No~RX~GLENMARK GENERICS LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~HIKMA PHARMS LLC
~EQ 4MG BASE~A~077545~001~~Sep 6, 2007~No~DISCN~HIKMA PHARMACEUTICALS LLC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~IPCA LABS LTD~EQ
4MG BASE~A~203761~001~AB~Jan 23, 2014~No~RX~IPCA LABORATORIES LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~IPCA LABS LTD~EQ
8MG BASE~A~203761~002~AB~Jan 23, 2014~No~RX~IPCA LABORATORIES LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~MYLAN~EQ 4MG BAS
E~A~076930~001~AB~Jun 25, 2007~No~RX~MYLAN PHARMACEUTICALS INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~MYLAN~EQ 8MG BAS
E~A~076930~002~AB~Jun 25, 2007~No~RX~MYLAN PHARMACEUTICALS INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~MYLAN~EQ 24MG BA
SE~A~076930~004~AB~Jun 25, 2007~No~RX~MYLAN PHARMACEUTICALS INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~NATCO PHARMA LTD
~EQ 4MG BASE~A~077851~001~AB~Jun 25, 2007~No~RX~NATCO PHARMA LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~NATCO PHARMA LTD
~EQ 8MG BASE~A~077851~002~AB~Jun 25, 2007~No~RX~NATCO PHARMA LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~PAR PHARM~EQ 4MG
BASE~A~077303~001~~Jun 25, 2007~No~DISCN~PAR PHARMACEUTICAL INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~PAR PHARM~EQ 8MG
BASE~A~077303~002~~Jun 25, 2007~No~DISCN~PAR PHARMACEUTICAL INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~PAR PHARM~EQ 24M
G BASE~A~077303~004~~Jun 25, 2007~No~DISCN~PAR PHARMACEUTICAL INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~PLIVA HRVATSKA D
OO~EQ 4MG BASE~A~077112~001~AB~Jun 25, 2007~No~RX~PLIVA HRVATSKA DOO
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~SANDOZ~EQ 4MG BA
SE~A~077517~001~AB~Jun 25, 2007~No~RX~SANDOZ INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~SANDOZ~EQ 8MG BA
SE~A~077517~002~AB~Jun 25, 2007~No~RX~SANDOZ INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~SANDOZ~EQ 24MG B
ASE~A~077517~003~AB~Jun 25, 2007~No~RX~SANDOZ INC

ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~SUN PHARM INDS (
IN)~EQ 4MG BASE~A~077050~001~AB~Jun 25, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES
LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~SUN PHARM INDS (
IN)~EQ 8MG BASE~A~077050~002~AB~Jun 25, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES
LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~TARO~EQ 4MG BASE
~A~077729~001~~Mar 28, 2011~No~DISCN~TARO PHARMACEUTICAL INDUSTRIES LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~TARO~EQ 8MG BASE
~A~077729~002~~Mar 28, 2011~No~DISCN~TARO PHARMACEUTICAL INDUSTRIES LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~TARO~EQ 24MG BAS
E~A~077729~003~~Mar 28, 2011~No~DISCN~TARO PHARMACEUTICAL INDUSTRIES LTD
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~TEVA~EQ 4MG BASE
~A~076252~001~AB~Jun 25, 2007~No~RX~TEVA PHARMACEUTICALS USA INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~TEVA~EQ 8MG BASE
~A~076252~002~AB~Jun 25, 2007~No~RX~TEVA PHARMACEUTICALS USA INC
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ONDANSETRON HYDROCHLORIDE~TEVA~EQ 24MG BAS
E~A~076252~003~AB~Jun 25, 2007~No~RX~TEVA PHARMACEUTICALS USA INC
CLOBAZAM~TABLET;ORAL~ONFI~LUNDBECK LLC~5MG~N~202067~001~~Oct 21, 2011~No~DISCN~L
UNDBECK LLC
CLOBAZAM~TABLET;ORAL~ONFI~LUNDBECK LLC~10MG~N~202067~002~~Oct 21, 2011~No~RX~LUN
DBECK LLC
CLOBAZAM~TABLET;ORAL~ONFI~LUNDBECK LLC~20MG~N~202067~003~~Oct 21, 2011~Yes~RX~LU
NDBECK LLC
SAXAGLIPTIN HYDROCHLORIDE~TABLET;ORAL~ONGLYZA~ASTRAZENECA AB~EQ 2.5MG BASE~N~022
350~001~~Jul 31, 2009~No~RX~ASTRAZENECA AB
SAXAGLIPTIN HYDROCHLORIDE~TABLET;ORAL~ONGLYZA~ASTRAZENECA AB~EQ 5MG BASE~N~02235
0~002~~Jul 31, 2009~Yes~RX~ASTRAZENECA AB
ITRACONAZOLE~TABLET;ORAL~ONMEL~MERZ PHARMS~200MG~N~022484~001~~Apr 29, 2010~Yes~
RX~MERZ PHARMACEUTICALS LLC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OPANA~ENDO PHARMS~5MG~N~021611~001~AB~Jun
22, 2006~No~RX~ENDO PHARMACEUTICALS INC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OPANA~ENDO PHARMS~10MG~N~021611~002~AB~Jun
22, 2006~Yes~RX~ENDO PHARMACEUTICALS INC
LEVONORGESTREL~TABLET;ORAL~OPCICON ONE-STEP~SUN PHARM INDS LTD~1.5MG~A~202635~00
1~~Sep 11, 2014~No~OTC~SUN PHARMACEUTICAL INDUSTRIES LTD
MACITENTAN~TABLET;ORAL~OPSUMIT~ACTELION PHARMS LTD~10MG~N~204410~001~~Oct 18, 20
AZATADINE MALEATE~TABLET;ORAL~OPTIMINE~SCHERING~1MG~N~017601~001~~Approved Prior
FLUOXYMESTERONE~TABLET;ORAL~ORA-TESTRYL~BRISTOL MYERS SQUIBB~2MG~N~011359~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
FLUOXYMESTERONE~TABLET;ORAL~ORA-TESTRYL~BRISTOL MYERS SQUIBB~5MG~N~011359~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
PIMOZIDE~TABLET;ORAL~ORAP~TEVA~1MG~N~017473~003~~Aug 27, 1997~No~RX~TEVA PHARMAC
EUTICALS USA INC
PIMOZIDE~TABLET;ORAL~ORAP~TEVA~2MG~N~017473~001~~Jul 31, 1984~Yes~RX~TEVA PHARMA
CEUTICALS USA INC
PREDNISONE~TABLET;ORAL~ORASONE~SOLVAY~1MG~A~083009~001~~Approved Prior to Jan 1,
PREDNISONE~TABLET;ORAL~ORASONE~SOLVAY~5MG~A~083009~002~~Approved Prior to Jan 1,
PREDNISONE~TABLET;ORAL~ORASONE~SOLVAY~10MG~A~083009~003~~Approved Prior to Jan 1
, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
HYDROCHLOROTHIAZIDE~TABLET;ORAL~ORETIC~ABBVIE~25MG~N~011971~001~~Approved Prior

HYDROCHLOROTHIAZIDE~TABLET;ORAL~ORETIC~ABBVIE~50MG~N~011971~002~AB~Approved Prio
r to Jan 1, 1982~No~RX~ABBVIE INC
DESERPIDINE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ORETICYL 25~ABBVIE~0.125MG;25MG~N~0
DESERPIDINE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ORETICYL 50~ABBVIE~0.125MG;50MG~N~0
DESERPIDINE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ORETICYL FORTE~ABBVIE~0.25MG;25MG~N
~012148~002~~Approved Prior to Jan 1, 1982~No~DISCN~ABBVIE INC
METHYLTESTOSTERONE~TABLET;ORAL~ORETON METHYL~SCHERING~10MG~N~003158~001~~Approve
METHYLTESTOSTERONE~TABLET;ORAL~ORETON METHYL~SCHERING~25MG~N~003158~002~~Approve
TOLBUTAMIDE~TABLET;ORAL~ORINASE~PHARMACIA AND UPJOHN~250MG~N~010670~002~~Approve
TOLBUTAMIDE~TABLET;ORAL~ORINASE~PHARMACIA AND UPJOHN~500MG~N~010670~001~~Approve
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE~TABLET;ORAL~ORPHENADRINE CITRATE, ASPIRI
N, AND CAFFEINE~SANDOZ~385MG;30MG;25MG~A~074654~001~AB~Dec 31, 1996~No~RX~SANDOZ
INC
N, AND CAFFEINE~SANDOZ~770MG;60MG;50MG~A~074654~002~AB~Dec 31, 1996~No~RX~SANDOZ
INC
N, AND CAFFEINE~STEVENS J~385MG;30MG;25MG~A~074988~001~~Apr 30, 1999~No~DISCN~JE
ROME STEVENS PHARMACEUTICALS INC
N, AND CAFFEINE~STEVENS J~770MG;60MG;50MG~A~074988~002~~Apr 30, 1999~No~DISCN~JE
ROME STEVENS PHARMACEUTICALS INC
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE~TABLET;ORAL~ORPHENGESIC~PRINSTON INC~385
MG;30MG;25MG~A~075141~001~~May 29, 1998~No~DISCN~PRINSTON PHARMACEUTICAL INC
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE~TABLET;ORAL~ORPHENGESIC FORTE~PRINSTON I
NC~770MG;60MG;50MG~A~075141~002~~May 29, 1998~No~DISCN~PRINSTON PHARMACEUTICAL I
NC
ESTROPIPATE~TABLET;ORAL~ORTHO-EST~SUN PHARM INDS INC~0.75MG~A~089567~001~~Feb 27
, 1991~No~DISCN~SUN PHARMACEUTICAL INDUSTRIES INC
ESTROPIPATE~TABLET;ORAL~ORTHO-EST~SUN PHARM INDS INC~1.5MG~A~089582~001~~Jul 17,
1991~No~DISCN~SUN PHARMACEUTICAL INDUSTRIES INC
KETOPROFEN~TABLET;ORAL~ORUDIS KT~WYETH CONS~12.5MG **Federal Register determinat
s**~N~020429~001~~Oct 6, 1995~No~DISCN~WYETH CONSUMER HEALTHCARE
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~ORVATEN~UPSHER SMITH~2.5MG~A~076725~001~AB~N
ov 3, 2004~No~RX~UPSHER SMITH LABORATORIES INC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~ORVATEN~UPSHER SMITH~5MG~A~076725~002~AB~Nov
3, 2004~No~RX~UPSHER SMITH LABORATORIES INC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~ORVATEN~UPSHER SMITH~10MG~A~076725~003~AB~No
v 3, 2004~No~RX~UPSHER SMITH LABORATORIES INC
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~OSENI~TAKEDA PHARMS
USA~EQ 12.5MG BASE;EQ 15MG BASE~N~022426~004~~Jan 25, 2013~No~RX~TAKEDA PHARMACE
UTICALS USA INC
UTICALS USA INC
UTICALS USA INC
USA~EQ 25MG BASE;EQ 15MG BASE~N~022426~001~~Jan 25, 2013~No~RX~TAKEDA PHARMACEUT
ICALS USA INC
USA~EQ 25MG BASE;EQ 30MG BASE~N~022426~002~~Jan 25, 2013~No~RX~TAKEDA PHARMACEUT

ICALS USA INC
USA~EQ 25MG BASE;EQ 45MG BASE~N~022426~003~~Jan 25, 2013~Yes~RX~TAKEDA PHARMACEU
TICALS USA INC
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE~T
ABLET;ORAL~OSMOPREP~SALIX PHARMS~0.398GM;1.102GM~N~021892~001~~Mar 16, 2006~Yes~
RX~SALIX PHARMACEUTICALS INC
OSPEMIFENE~TABLET;ORAL~OSPHENA~SHIONOGI INC~60MG~N~203505~001~~Feb 26, 2013~Yes~
RX~SHIONOGI INC
APREMILAST~TABLET;ORAL~OTEZLA~CELGENE CORP~10MG~N~205437~001~~Mar 21, 2014~No~RX
~CELGENE CORP
APREMILAST~TABLET;ORAL~OTEZLA~CELGENE CORP~20MG~N~205437~002~~Mar 21, 2014~No~RX
~CELGENE CORP
APREMILAST~TABLET;ORAL~OTEZLA~CELGENE CORP~30MG~N~205437~003~~Mar 21, 2014~Yes~R
X~CELGENE CORP
NORGESTREL~TABLET;ORAL~OVRETTE~WYETH PHARMS~0.075MG~N~017031~001~~Approved Prior
to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICALS INC SUB PFIZER INC
OXANDROLONE~TABLET;ORAL~OXANDRIN~CREALTA PHARMS LLC~2.5MG~N~013718~001~AB~Approv
ed Prior to Jan 1, 1982~No~RX~CREALTA PHARMACEUTICALS LLC
OXANDROLONE~TABLET;ORAL~OXANDRIN~CREALTA PHARMS LLC~10MG~N~013718~002~AB~Nov 5,
2001~Yes~RX~CREALTA PHARMACEUTICALS LLC
OXANDROLONE~TABLET;ORAL~OXANDROLONE~PAR PHARM~2.5MG~A~077827~001~AB~Jun 22, 2007
~No~RX~PAR PHARMACEUTICAL INC
OXANDROLONE~TABLET;ORAL~OXANDROLONE~PAR PHARM~10MG~A~077827~002~AB~Jun 22, 2007~
No~RX~PAR PHARMACEUTICAL INC
OXANDROLONE~TABLET;ORAL~OXANDROLONE~ROXANE~2.5MG~A~077249~001~~Jul 10, 2007~No~D
OXANDROLONE~TABLET;ORAL~OXANDROLONE~ROXANE~10MG~A~077249~002~~Jul 10, 2007~No~DI
OXANDROLONE~TABLET;ORAL~OXANDROLONE~SANDOZ~2.5MG~A~076897~001~~Dec 1, 2006~No~DI
SCN~SANDOZ INC
OXANDROLONE~TABLET;ORAL~OXANDROLONE~SANDOZ~10MG~A~076897~002~~Dec 1, 2006~No~DIS
CN~SANDOZ INC
OXANDROLONE~TABLET;ORAL~OXANDROLONE~UPSHER SMITH~2.5MG~A~076761~001~AB~Dec 1, 20
06~No~RX~UPSHER SMITH LABORATORIES INC
OXANDROLONE~TABLET;ORAL~OXANDROLONE~UPSHER SMITH~10MG~A~078033~001~AB~Mar 22, 20
07~No~RX~UPSHER SMITH LABORATORIES INC
OXAPROZIN~TABLET;ORAL~OXAPROZIN~ACTAVIS ELIZABETH~600MG~A~075843~001~~Oct 3, 200
OXAPROZIN~TABLET;ORAL~OXAPROZIN~APOTEX INC~600MG~A~075987~001~AB~Sep 2, 2004~No~
OXAPROZIN~TABLET;ORAL~OXAPROZIN~DR REDDYS LABS LTD~600MG~A~075855~001~AB~Jan 31,
OXAPROZIN~TABLET;ORAL~OXAPROZIN~IVAX SUB TEVA PHARMS~600MG~A~075846~001~AB~May 1
OXAPROZIN~TABLET;ORAL~OXAPROZIN~MYLAN~600MG~A~075851~001~~Aug 17, 2001~No~DISCN~
OXAPROZIN~TABLET;ORAL~OXAPROZIN~MYLAN PHARMS INC~600MG~A~075847~001~~Feb 28, 200
OXAPROZIN~TABLET;ORAL~OXAPROZIN~SANDOZ~600MG~A~075842~001~~Apr 12, 2001~No~DISCN
~SANDOZ INC
OXAPROZIN~TABLET;ORAL~OXAPROZIN~SANDOZ~600MG~A~075845~001~AB~Jan 31, 2001~No~RX~
SANDOZ INC
OXAPROZIN~TABLET;ORAL~OXAPROZIN~SANDOZ~600MG~A~075850~001~~Apr 27, 2001~No~DISCN
~SANDOZ INC
OXAPROZIN~TABLET;ORAL~OXAPROZIN~SUN PHARM INDS INC~600MG~A~075844~001~AB~Jan 3,
OXAPROZIN~TABLET;ORAL~OXAPROZIN~TEVA~600MG~A~075849~001~AB~Jul 3, 2002~No~RX~TEV
OXAPROZIN~TABLET;ORAL~OXAPROZIN~WATSON LABS~600MG~A~075848~001~~Feb 9, 2001~No~D

ISCN~WATSON LABORATORIES
OXAZEPAM~TABLET;ORAL~OXAZEPAM~MUTUAL PHARM~15MG~A~070683~001~~Jan 16, 1987~No~DI
SCN~MUTUAL PHARMACEUTICAL CO INC
OXAZEPAM~TABLET;ORAL~OXAZEPAM~PARKE DAVIS~15MG~A~071508~001~~Feb 2, 1987~No~DISC
N~PARKE DAVIS DIV WARNER LAMBERT CO
OXAZEPAM~TABLET;ORAL~OXAZEPAM~WATSON LABS~15MG~A~071494~001~~Apr 21, 1987~No~DIS
OXCARBAZEPINE~TABLET;ORAL~OXCARBAZEPINE~ANI PHARMS INC~150MG~A~078005~001~~Dec 1
OXCARBAZEPINE~TABLET;ORAL~OXCARBAZEPINE~APOTEX INC~150MG~A~077747~001~AB~Apr 9,
OXCARBAZEPINE~TABLET;ORAL~OXCARBAZEPINE~BRECKENRIDGE PHARM~150MG~A~078069~001~AB
~Jan 11, 2008~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
OXCARBAZEPINE~TABLET;ORAL~OXCARBAZEPINE~CADISTA PHARMS~150MG~A~090239~001~AB~Jan
25, 2010~No~RX~CADISTA PHARMACEUTICALS INC
OXCARBAZEPINE~TABLET;ORAL~OXCARBAZEPINE~GLENMARK GENERICS~150MG~A~077802~001~AB~
Oct 9, 2007~No~RX~GLENMARK GENERICS LTD
OXCARBAZEPINE~TABLET;ORAL~OXCARBAZEPINE~ROXANE~150MG~A~077795~001~AB~Oct 9, 2007
OXCARBAZEPINE~TABLET;ORAL~OXCARBAZEPINE~SUN PHARM INDS~150MG~A~077794~001~AB~Oct
OXCARBAZEPINE~TABLET;ORAL~OXCARBAZEPINE~TARO~150MG~A~077801~001~AB~Nov 15, 2007~
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXECTA~ACURA PHARMS INC~5MG~N~202080~001~~Ju
n 17, 2011~No~RX~ACURA PHARMACEUTICALS INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXECTA~ACURA PHARMS INC~7.5MG~N~202080~002~~
Jun 17, 2011~No~RX~ACURA PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~TABLET;ORAL~OXYBUTYNIN CHLORIDE~QUANTUM PHARMICS~5MG~A~07229

6~001~~Dec 8, 1988~No~DISCN~QUANTUM PHARMICS LTD
OXYBUTYNIN CHLORIDE~TABLET;ORAL~OXYBUTYNIN CHLORIDE~TEVA PHARMS USA~5MG~A~071655
~001~AB~Nov 14, 1988~No~RX~TEVA PHARMACEUTICALS USA INC
OXYBUTYNIN CHLORIDE~TABLET;ORAL~OXYBUTYNIN CHLORIDE~USL PHARMA~5MG~A~070746~001~
~Mar 10, 1988~No~DISCN~USL PHARMA INC
OXYBUTYNIN CHLORIDE~TABLET;ORAL~OXYBUTYNIN CHLORIDE~USL PHARMA~5MG~A~074625~001~
AB~Jul 31, 1996~No~RX~USL PHARMA INC
OXYBUTYNIN CHLORIDE~TABLET;ORAL~OXYBUTYNIN CHLORIDE~VINTAGE PHARMS~5MG~A~075079~
001~AB~Oct 31, 1997~Yes~RX~VINTAGE PHARMACEUTICALS INC
OXYBUTYNIN CHLORIDE~TABLET;ORAL~OXYBUTYNIN CHLORIDE~WATSON LABS~5MG~A~072485~001
~~Apr 19, 1989~No~DISCN~WATSON LABORATORIES INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCET~MALLINCKRODT~325MG;5MG
~A~087463~001~AA~Dec 7, 1983~No~RX~MALLINCKRODT INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE 2.5/APAP 500~BRISTO
L MYERS SQUIBB~500MG;2.5MG~A~085910~001~~Approved Prior to Jan 1, 1982~No~DISCN~
BRISTOL MYERS SQUIBB PHARMA CO
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE 5/APAP 500~BRISTOL
MYERS SQUIBB~500MG;5MG~A~085911~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRIS
TOL MYERS SQUIBB PHARMA CO
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~A
CTAVIS ELIZABETH~325MG;2.5MG~A~201447~001~AA~Apr 12, 2013~No~RX~ACTAVIS ELIZABET
H LLC
CTAVIS ELIZABETH~325MG;5MG~A~040203~001~~Mar 15, 1999~No~DISCN~ACTAVIS ELIZABETH
LLC
CTAVIS ELIZABETH~325MG;5MG~A~201447~002~AA~Apr 12, 2013~No~RX~ACTAVIS ELIZABETH
LLC
CTAVIS ELIZABETH~325MG;7.5MG~A~040800~001~~Apr 3, 2012~No~DISCN~ACTAVIS ELIZABET
H LLC
CTAVIS ELIZABETH~325MG;7.5MG~A~201447~003~AA~Apr 12, 2013~No~RX~ACTAVIS ELIZABET
H LLC
CTAVIS ELIZABETH~325MG;10MG~A~040800~002~~Apr 3, 2012~No~DISCN~ACTAVIS ELIZABETH
LLC
CTAVIS ELIZABETH~325MG;10MG~A~201447~004~AA~Apr 12, 2013~No~RX~ACTAVIS ELIZABETH
LLC
LVOGEN INC~325MG;7.5MG~A~202677~001~AA~Jul 26, 2012~No~RX~ALVOGEN INC
LVOGEN INC~325MG;10MG~A~202677~002~AA~Jul 26, 2012~No~RX~ALVOGEN INC
MNEAL PHARMS NY~325MG;5MG~A~040777~001~AA~Nov 27, 2007~No~RX~AMNEAL PHARMACEUTIC
ALS NY LLC
MNEAL PHARMS NY~325MG;10MG~A~040778~001~AA~Nov 27, 2007~No~RX~AMNEAL PHARMACEUTI
CALS NY LLC
MNEAL PHARMS NY~500MG;7.5MG~A~040789~001~~Nov 27, 2007~No~DISCN~AMNEAL PHARMACEU
TICALS NY LLC
MNEAL PHARMS NY~650MG;10MG~A~040789~002~~Nov 27, 2007~No~DISCN~AMNEAL PHARMACEUT
ICALS NY LLC
UROLIFE PHARMA LLC~325MG;2.5MG~A~201972~001~AA~Jul 15, 2013~No~RX~AUROLIFE PHARM
A LLC

UROLIFE PHARMA LLC~325MG;5MG~A~201972~002~AA~Jul 15, 2013~No~RX~AUROLIFE PHARMA
LLC
UROLIFE PHARMA LLC~325MG;7.5MG~A~201972~003~AA~Jul 15, 2013~No~RX~AUROLIFE PHARM
A LLC
UROLIFE PHARMA LLC~325MG;10MG~A~201972~004~AA~Jul 15, 2013~No~RX~AUROLIFE PHARMA
LLC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~B
ARR~325MG;5MG~A~087406~001~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORATO
RIES INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~C
OASTAL PHARMS~325MG;2.5MG~A~090177~001~AA~Oct 20, 2008~No~RX~COASTAL PHARMACEUTI
CALS
OASTAL PHARMS~325MG;5MG~A~090177~002~AA~Oct 20, 2008~No~RX~COASTAL PHARMACEUTICA
LS
OASTAL PHARMS~325MG;7.5MG~A~090177~003~AA~Oct 20, 2008~No~RX~COASTAL PHARMACEUTI
CALS
OASTAL PHARMS~325MG;10MG~A~090177~004~AA~Oct 20, 2008~No~RX~COASTAL PHARMACEUTIC
ALS
OASTAL PHARMS~500MG;7.5MG~A~090177~005~~Oct 20, 2008~No~DISCN~COASTAL PHARMACEUT
ICALS
OASTAL PHARMS~650MG;10MG~A~090177~006~~Oct 20, 2008~No~DISCN~COASTAL PHARMACEUTI
CALS
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~D
URAMED PHARMS BARR~325MG;5MG~A~040272~001~~Jun 30, 1998~No~DISCN~DURAMED PHARMAC
EUTICALS INC SUB BARR LABORATORIES INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~M
ALLINCKRODT~325MG;7.5MG~A~040545~001~AA~Jun 30, 2004~No~RX~MALLINCKRODT INC
ALLINCKRODT~325MG;10MG~A~040545~002~AA~Jun 30, 2004~No~RX~MALLINCKRODT INC
ALLINCKRODT~500MG;7.5MG~A~040550~001~~Jun 30, 2004~No~DISCN~MALLINCKRODT INC
ALLINCKRODT~650MG;10MG~A~040550~002~~Jun 30, 2004~No~DISCN~MALLINCKRODT INC
IKART~300MG;2.5MG~A~040608~001~~Dec 30, 2005~Yes~RX~MIKART INC
IKART~300MG;5MG~A~040608~002~~Dec 30, 2005~Yes~RX~MIKART INC
IKART~300MG;7.5MG~A~040608~003~~Dec 30, 2005~Yes~RX~MIKART INC
IKART~300MG;10MG~A~040608~004~~Dec 30, 2005~Yes~RX~MIKART INC
IKART~400MG;2.5MG~A~040679~001~~May 16, 2006~No~DISCN~MIKART INC
IKART~400MG;5MG~A~040687~001~~Apr 27, 2006~No~DISCN~MIKART INC
IKART~400MG;7.5MG~A~040698~001~~Apr 27, 2006~No~DISCN~MIKART INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~R
HODES PHARMS~325MG;5MG~A~201278~001~AA~Aug 28, 2014~No~RX~RHODES PHARMACEUTICALS

LP
HODES PHARMS~325MG;7.5MG~A~201278~002~AA~Aug 28, 2014~No~RX~RHODES PHARMACEUTICA
LS LP
HODES PHARMS~325MG;10MG~A~201278~003~AA~Aug 28, 2014~No~RX~RHODES PHARMACEUTICAL
S LP
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~S
UN PHARM INDS INC~325MG;2.5MG~A~090535~001~AA~Dec 26, 2013~No~RX~SUN PHARMACEUTI
CAL INDUSTRIES INC
UN PHARM INDS INC~325MG;5MG~A~090535~002~AA~Dec 26, 2013~No~RX~SUN PHARMACEUTICA
L INDUSTRIES INC
UN PHARM INDS INC~325MG;7.5MG~A~090535~003~AA~Dec 26, 2013~No~RX~SUN PHARMACEUTI
CAL INDUSTRIES INC
UN PHARM INDS INC~325MG;10MG~A~090535~004~AA~Dec 26, 2013~No~RX~SUN PHARMACEUTIC
AL INDUSTRIES INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~V
INTAGE PHARMS~325MG;2.5MG~A~090733~001~AA~Jul 11, 2013~No~RX~VINTAGE PHARMACEUTI
CALS INC
INTAGE PHARMS~325MG;5MG~A~040105~001~AA~Jul 30, 1996~No~RX~VINTAGE PHARMACEUTICA
LS INC
INTAGE PHARMS~325MG;7.5MG~A~090734~001~AA~Jul 11, 2013~No~RX~VINTAGE PHARMACEUTI
CALS INC
INTAGE PHARMS~325MG;10MG~A~090734~002~AA~Jul 11, 2013~No~RX~VINTAGE PHARMACEUTIC
ALS INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ACETAMINOPHEN~W
ATSON LABS~325MG;5MG~A~040171~001~AA~Oct 30, 1997~No~RX~WATSON LABORATORIES INC
ATSON LABS~325MG;7.5MG~A~040535~001~AA~Sep 5, 2003~No~RX~WATSON LABORATORIES INC
ATSON LABS~325MG;10MG~A~040535~002~AA~Sep 5, 2003~No~RX~WATSON LABORATORIES INC
ATSON LABS~500MG;7.5MG~A~040371~001~~Dec 29, 2000~No~DISCN~WATSON LABORATORIES
ATSON LABS~650MG;10MG~A~040371~002~~Dec 29, 2000~No~DISCN~WATSON LABORATORIES
ASPIRIN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ASPIRIN~COASTAL PHARM
S~325MG;4.8355MG~A~091670~001~AA~Mar 16, 2011~No~RX~COASTAL PHARMACEUTICALS
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE~TABLET;ORAL~OXYCODONE
AND ASPIRIN~MUTUAL PHARM~325MG;4.5MG;0.38MG~A~040260~001~~Jul 17, 1998~No~DISCN~
MUTUAL PHARMACEUTICAL CO INC
AND ASPIRIN~MUTUAL PHARM~325MG;4.5MG;0.38MG~A~087794~001~~May 26, 1982~No~DISCN~
MUTUAL PHARMACEUTICAL CO INC
AND ASPIRIN~WATSON LABS~325MG;4.5MG;0.38MG~A~040255~001~~Feb 27, 1998~No~DISCN~W
ASPIRIN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE AND ASPIRIN~WATSON LABS~3
25MG;4.8355MG~A~090084~001~AA~Mar 22, 2011~No~RX~WATSON LABORATORIES INC
AND ASPIRIN (HALF-STRENGTH)~ROXANE~325MG;2.25MG;0.19MG~A~087742~001~~Jun 4, 1982
~No~DISCN~ROXANE LABORATORIES INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~ACTAVIS ELIZABETH~15
MG~A~076636~001~AB~Feb 6, 2004~No~RX~ACTAVIS ELIZABETH LLC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~ACTAVIS ELIZABETH~30

MG~A~076636~002~AB~Feb 6, 2004~No~RX~ACTAVIS ELIZABETH LLC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~ALVOGEN INC~5MG~A~20
2116~001~AB~Dec 30, 2011~No~RX~ALVOGEN INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~AMNEAL PHARMS~5MG~A~
203638~001~AB~Jun 3, 2014~No~RX~AMNEAL PHARMACEUTICALS
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~AMNEAL PHARMS~10MG~A
~203638~002~AB~Jun 3, 2014~No~RX~AMNEAL PHARMACEUTICALS
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~AUROLIFE PHARMA LLC~
5MG~A~202160~001~AB~Nov 19, 2012~No~RX~AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~AVANTHI INC~5MG~A~09
1393~001~AB~Aug 31, 2009~No~RX~AVANTHI INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~COASTAL PHARMS~5MG~A
~091313~001~AB~Feb 18, 2011~No~RX~COASTAL PHARMACEUTICALS
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~COASTAL PHARMS~15MG~
A~091313~002~AB~Feb 18, 2011~No~RX~COASTAL PHARMACEUTICALS
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~COASTAL PHARMS~30MG~
A~091313~003~AB~Feb 18, 2011~No~RX~COASTAL PHARMACEUTICALS
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~COREPHARMA~5MG~A~090
895~001~AB~Aug 24, 2009~No~RX~COREPHARMA LLC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~MALLINCKRODT INC~5MG
~A~076758~003~AB~Mar 19, 2007~No~RX~MALLINCKRODT INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~MALLINCKRODT INC~15M
G~A~076758~001~AB~Jun 30, 2004~No~RX~MALLINCKRODT INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~MALLINCKRODT INC~30M
G~A~076758~002~AB~Jun 30, 2004~No~RX~MALLINCKRODT INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~NESHER PHARMS~5MG~A~
077290~001~AB~Dec 8, 2005~No~RX~NESHER PHARMACEUTICALS USA LLC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~NESHER PHARMS~10MG~A
~077290~002~AB~Dec 8, 2005~No~RX~NESHER PHARMACEUTICALS USA LLC

OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~RHODES PHARMS~5MG~A~
091490~001~AB~Mar 9, 2011~No~RX~RHODES PHARMACEUTICALS LP
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~RHODES PHARMS~10MG~A
~091490~002~AB~Mar 9, 2011~No~RX~RHODES PHARMACEUTICALS LP
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~SUN PHARM INDS INC~5
MG~A~090659~001~AB~Apr 10, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
0MG~A~090659~005~AB~Nov 6, 2012~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
5MG~A~090659~002~AB~Apr 10, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
0MG~A~090659~004~AB~Nov 6, 2012~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
0MG~A~090659~003~AB~Apr 10, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~VINTAGE PHARMS~5MG~A
~077712~003~AB~Mar 2, 2009~No~RX~VINTAGE PHARMACEUTICALS INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~VINTAGE PHARMS~15MG~
A~077712~001~AB~Jan 31, 2007~No~RX~VINTAGE PHARMACEUTICALS INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE~VINTAGE PHARMS~30MG~
A~077712~002~AB~Jan 31, 2007~No~RX~VINTAGE PHARMACEUTICALS INC
IBUPROFEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~OXYCODONE HYDROCHLORIDE AND IBUPR
OFEN~ACTAVIS ELIZABETH~400MG;5MG~A~078769~001~AB~Jan 4, 2008~No~RX~ACTAVIS ELIZA
BETH LLC
OFEN~BARR LABS INC~400MG;5MG~A~078316~001~AB~Nov 29, 2007~Yes~RX~BARR LABORATORI
ES INC
OFEN~WATSON LABS~400MG;5MG~A~078394~001~AB~Nov 26, 2007~No~RX~WATSON LABORATORIE
S INC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~AVANTHI INC~5MG~
A~203601~001~AB~Jan 30, 2013~No~RX~AVANTHI INC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~AVANTHI INC~10MG
~A~203601~002~AB~Jan 30, 2013~No~RX~AVANTHI INC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~COREPHARMA~5MG~A
~201187~001~AB~Dec 15, 2014~No~RX~COREPHARMA LLC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~COREPHARMA~10MG~
A~201187~002~AB~Dec 15, 2014~No~RX~COREPHARMA LLC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~MALLINCKRODT INC
~5MG~A~202321~001~AB~Apr 25, 2013~No~RX~MALLINCKRODT INC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~MALLINCKRODT INC
~10MG~A~202321~002~AB~Apr 25, 2013~No~RX~MALLINCKRODT INC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~ROXANE~5MG~A~090
964~001~AB~Sep 27, 2010~No~RX~ROXANE LABORATORIES INC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~ROXANE~10MG~A~09
0964~002~AB~Sep 27, 2010~No~RX~ROXANE LABORATORIES INC
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~TEVA~5MG~A~09144
OXYMORPHONE HYDROCHLORIDE~TABLET;ORAL~OXYMORPHONE HYDROCHLORIDE~TEVA~10MG~A~0914
OXYPHENBUTAZONE~TABLET;ORAL~OXYPHENBUTAZONE~WATSON LABS~100MG~A~088399~001~~Sep
AMIODARONE HYDROCHLORIDE~TABLET;ORAL~PACERONE~UPSHER SMITH~100MG~A~075135~002~AB
~Apr 12, 2005~No~RX~UPSHER SMITH LABORATORIES INC

AMIODARONE HYDROCHLORIDE~TABLET;ORAL~PACERONE~UPSHER SMITH~200MG~A~075135~001~AB
~Apr 30, 1998~No~RX~UPSHER SMITH LABORATORIES INC
CYCRIMINE HYDROCHLORIDE~TABLET;ORAL~PAGITANE~LILLY~1.25MG~N~008951~001~~Approved
CYCRIMINE HYDROCHLORIDE~TABLET;ORAL~PAGITANE~LILLY~2.5MG~N~008951~002~~Approved
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~PAMINE~FOUGERA PHARMS~2.5MG~N~008848~001~AA~
Approved Prior to Jan 1, 1982~Yes~RX~FOUGERA PHARMACEUTICALS INC
METHSCOPOLAMINE BROMIDE~TABLET;ORAL~PAMINE FORTE~FOUGERA PHARMS~5MG~N~008848~002
~AA~Mar 25, 2003~Yes~RX~FOUGERA PHARMACEUTICALS INC
TETRACYCLINE HYDROCHLORIDE~TABLET;ORAL~PANMYCIN~PHARMACIA AND UPJOHN~250MG~A~061
TETRACYCLINE HYDROCHLORIDE~TABLET;ORAL~PANMYCIN~PHARMACIA AND UPJOHN~500MG~A~061
WARFARIN SODIUM~TABLET;ORAL~PANWARFIN~ABBOTT~2MG~N~017020~001~~Approved Prior to
WARFARIN SODIUM~TABLET;ORAL~PANWARFIN~ABBOTT~2.5MG~N~017020~002~~Approved Prior
WARFARIN SODIUM~TABLET;ORAL~PANWARFIN~ABBOTT~5MG~N~017020~003~~Approved Prior to
WARFARIN SODIUM~TABLET;ORAL~PANWARFIN~ABBOTT~7.5MG~N~017020~004~~Approved Prior
WARFARIN SODIUM~TABLET;ORAL~PANWARFIN~ABBOTT~10MG~N~017020~005~~Approved Prior t
o Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~PAPA-DEINE #3~VANGARD~300MG;30MG~A~
088037~001~~Mar 20, 1984~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~PAPA-DEINE #4~VANGARD~300MG;60MG~A~
088715~001~~Mar 20, 1984~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
PREDNISONE~TABLET;ORAL~PARACORT~PARKE DAVIS~5MG~N~010962~002~~Approved Prior to
Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
CHLORZOXAZONE~TABLET;ORAL~PARAFLEX~ORTHO MCNEIL PHARM~250MG **Federal Register d
cy reasons**~N~011300~003~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL P
HARMACEUTICAL INC
CHLORZOXAZONE~TABLET;ORAL~PARAFON FORTE DSC~JANSSEN R AND D~500MG~N~011529~002~A
A~Jun 15, 1987~Yes~RX~JANSSEN RESEARCH AND DEVELOPMENT LLC
AMINOSALICYLIC ACID~TABLET;ORAL~PARASAL~PANRAY~1GM~N~006811~002~~Approved Prior
to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
AMINOSALICYLIC ACID~TABLET;ORAL~PARASAL~PANRAY~500MG~N~006811~001~~Approved Prio
AMINOSALICYLATE SODIUM~TABLET;ORAL~PARASAL SODIUM~PANRAY~1GM~N~006811~011~~Appro
ved Prior to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO IN
C
AMINOSALICYLATE SODIUM~TABLET;ORAL~PARASAL SODIUM~PANRAY~500MG~N~006811~006~~App
roved Prior to Jan 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO
INC
BROMOCRIPTINE MESYLATE~TABLET;ORAL~PARLODEL~US PHARMS HOLDINGS I~EQ 2.5MG BASE~N
~017962~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~US PHARMACEUTICALS HOLDINGS
I LLC
TRANYLCYPROMINE SULFATE~TABLET;ORAL~PARNATE~COVIS PHARMA~EQ 10MG BASE~N~012342~0
03~AB~Aug 16, 1985~Yes~RX~COVIS PHARMA SARL
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE~PRINSTON INC~EQ 10MG BASE~A~2038
54~001~AB~Oct 31, 2014~No~RX~PRINSTON PHARMACEUTICAL INC
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~APOTEX~EQ 10MG BAS

E~A~075356~001~AB~Jul 30, 2003~No~RX~APOTEX INC
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~AUROBINDO PHARMA~E
Q 10MG BASE~A~078406~001~AB~Jul 25, 2007~No~RX~AUROBINDO PHARMA LTD
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~MYLAN~EQ 10MG BASE
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~MYLAN PHARMS INC~E
Q 10MG BASE~A~075716~001~AB~Mar 8, 2004~No~RX~MYLAN PHARMACEUTICALS INC
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~PROSAM LABS~EQ 10M
G BASE~A~076968~001~AB~Jun 21, 2010~No~RX~PROSAM LABS LLC
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~ROXANE~EQ 10MG BAS
E~A~078026~001~~Jun 29, 2007~No~DISCN~ROXANE LABORATORIES INC
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~SANDOZ~EQ 10MG BAS
E~A~075566~001~~Mar 8, 2004~No~DISCN~SANDOZ INC
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~SUN PHARM INDS INC
~EQ 10MG BASE~A~078194~001~AB~Jun 29, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES I
NC

NC
NC
NC
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~TEVA~EQ 10MG BASE~
A~076618~001~AB~Aug 15, 2005~No~RX~TEVA PHARMACEUTICALS USA INC
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~TEVA PHARMS~EQ 10M
G BASE~A~077082~001~~Jun 29, 2007~No~DISCN~TEVA PHARMACEUTICALS USA
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAROXETINE HYDROCHLORIDE~ZYDUS PHARMS USA~E
Q 10MG BASE~A~077584~001~AB~Mar 7, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
ETHOPROPAZINE HYDROCHLORIDE~TABLET;ORAL~PARSIDOL~PARKE DAVIS~10MG~N~009078~003~~
ETHOPROPAZINE HYDROCHLORIDE~TABLET;ORAL~PARSIDOL~PARKE DAVIS~50MG~N~009078~006~~
ETHOPROPAZINE HYDROCHLORIDE~TABLET;ORAL~PARSIDOL~PARKE DAVIS~100MG~N~009078~008~
POTASSIUM AMINOSALICYLATE~TABLET;ORAL~PASKALIUM~GLENWOOD~1GM~N~009395~003~~Appro
ved Prior to Jan 1, 1982~No~DISCN~GLENWOOD INC
TRIDIHEXETHYL CHLORIDE~TABLET;ORAL~PATHILON~LEDERLE~25MG~N~009489~005~~Approved
Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
PAROXETINE HYDROCHLORIDE~TABLET;ORAL~PAXIL~APOTEX TECHNOLOGIES~EQ 10MG BASE~N~02
0031~001~AB~Dec 29, 1992~No~RX~APOTEX TECHNOLOGIES INC
0031~005~AB~Dec 29, 1992~Yes~RX~APOTEX TECHNOLOGIES INC
0031~004~~Dec 29, 1992~No~DISCN~APOTEX TECHNOLOGIES INC
HALAZEPAM~TABLET;ORAL~PAXIPAM~SCHERING~20MG~N~017736~003~~Approved Prior to Jan
HALAZEPAM~TABLET;ORAL~PAXIPAM~SCHERING~40MG~N~017736~004~~Approved Prior to Jan
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~PBZ~NOVARTIS~25MG~A~083149~001~~Approve
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~PBZ~NOVARTIS~50MG~N~005914~002~~Approve
ETHOTOIN~TABLET;ORAL~PEGANONE~RECORDATI RARE~250MG~N~010841~001~~Approved Prior

to Jan 1, 1982~Yes~RX~RECORDATI RARE DISEASES INC
ETHOTOIN~TABLET;ORAL~PEGANONE~RECORDATI RARE~500MG~N~010841~003~~Approved Prior
to Jan 1, 1982~No~DISCN~RECORDATI RARE DISEASES INC
PEMOLINE~TABLET;ORAL~PEMOLINE~ACTAVIS ELIZABETH~18.75MG~A~075595~001~~Feb 28, 20
PEMOLINE~TABLET;ORAL~PEMOLINE~ACTAVIS ELIZABETH~37.5MG~A~075595~002~~Feb 28, 200
PEMOLINE~TABLET;ORAL~PEMOLINE~ACTAVIS ELIZABETH~75MG~A~075595~003~~Feb 28, 2000~
PEMOLINE~TABLET;ORAL~PEMOLINE~MALLINCKRODT~18.75MG~A~075726~003~~Mar 30, 2001~No
~DISCN~MALLINCKRODT INC
PEMOLINE~TABLET;ORAL~PEMOLINE~MALLINCKRODT~37.5MG~A~075726~002~~Mar 30, 2001~No~
DISCN~MALLINCKRODT INC
PEMOLINE~TABLET;ORAL~PEMOLINE~MALLINCKRODT~75MG~A~075726~001~~Mar 30, 2001~No~DI
SCN~MALLINCKRODT INC
PEMOLINE~TABLET;ORAL~PEMOLINE~SANDOZ~18.75MG~A~075286~001~~Dec 27, 1999~No~DISCN
~SANDOZ INC
PEMOLINE~TABLET;ORAL~PEMOLINE~SANDOZ~37.5MG~A~075286~002~~Jun 30, 1999~No~DISCN~
SANDOZ INC
PEMOLINE~TABLET;ORAL~PEMOLINE~SANDOZ~75MG~A~075286~003~~Jun 30, 1999~No~DISCN~SA
NDOZ INC
PEMOLINE~TABLET;ORAL~PEMOLINE~TEVA PHARMS~18.75MG~A~075030~003~~Feb 22, 2000~No~
PEMOLINE~TABLET;ORAL~PEMOLINE~TEVA PHARMS~37.5MG~A~075030~001~~Jan 29, 1999~No~D
PEMOLINE~TABLET;ORAL~PEMOLINE~TEVA PHARMS~75MG~A~075030~002~~Jan 29, 1999~No~DIS
CN~TEVA PHARMACEUTICALS USA
PEMOLINE~TABLET;ORAL~PEMOLINE~VINTAGE PHARMS~18.75MG~A~075328~001~~Apr 19, 2000~
No~DISCN~VINTAGE PHARMACEUTICALS INC
PEMOLINE~TABLET;ORAL~PEMOLINE~VINTAGE PHARMS~37.5MG~A~075328~002~~Apr 19, 2000~N
o~DISCN~VINTAGE PHARMACEUTICALS INC
PEMOLINE~TABLET;ORAL~PEMOLINE~VINTAGE PHARMS~75MG~A~075328~003~~Apr 19, 2000~No~
DISCN~VINTAGE PHARMACEUTICALS INC
PEMOLINE~TABLET;ORAL~PEMOLINE~WATSON LABS~18.75MG~A~075287~001~~Jun 13, 2001~No~
PEMOLINE~TABLET;ORAL~PEMOLINE~WATSON LABS~37.5MG~A~075287~002~~Sep 18, 2000~No~D
PEMOLINE~TABLET;ORAL~PEMOLINE~WATSON LABS~75MG~A~075287~003~~Sep 18, 2000~No~DIS
PENICILLIN V POTASSIUM~TABLET;ORAL~PEN-VEE K~WYETH AYERST~EQ 125MG BASE~A~060006
PENICILLIN V POTASSIUM~TABLET;ORAL~PENAPAR-VK~PARKE DAVIS~EQ 250MG BASE~A~062001
PENICILLIN V POTASSIUM~TABLET;ORAL~PENAPAR-VK~PARKE DAVIS~EQ 500MG BASE~A~062001
ENOXACIN~TABLET;ORAL~PENETREX~SANOFI AVENTIS US~200MG~N~019616~004~~Dec 31, 1991
~No~DISCN~SANOFI AVENTIS US LLC
ENOXACIN~TABLET;ORAL~PENETREX~SANOFI AVENTIS US~400MG~N~019616~005~~Dec 31, 1991
~No~DISCN~SANOFI AVENTIS US LLC
PENICILLIN G POTASSIUM~TABLET;ORAL~PENICILLIN G POTASSIUM~APOTHECON~250,000 UNIT
S~A~060392~003~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL MYE
RS SQUIBB CO
PENICILLIN G POTASSIUM~TABLET;ORAL~PENICILLIN G POTASSIUM~IVAX SUB TEVA PHARMS~4
00,000 UNITS~A~060073~004~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEU
PENICILLIN G POTASSIUM~TABLET;ORAL~PENICILLIN G POTASSIUM~LILLY~250,000 UNITS~A~

PENICILLIN G POTASSIUM~TABLET;ORAL~PENICILLIN G POTASSIUM~MYLAN~200,000 UNITS~A~
PENICILLIN G POTASSIUM~TABLET;ORAL~PENICILLIN G POTASSIUM~PUREPAC PHARM~200,000
UNITS~A~061588~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICA
L CO
L CO
L CO
PENICILLIN G POTASSIUM~TABLET;ORAL~PENICILLIN G POTASSIUM~TEVA~200,000 UNITS~A~0
PENICILLIN G POTASSIUM~TABLET;ORAL~PENICILLIN G POTASSIUM~WYETH AYERST~200,000 U
NITS~A~060413~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATOR
IES
IES
IES
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~AM ANTIBIOTICS~EQ 250M
G BASE~A~061528~001~~Approved Prior to Jan 1, 1982~No~DISCN~AMERICAN ANTIBIOTICS
LLC
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~AM ANTIBIOTICS~EQ 500M
G BASE~A~061528~002~~Approved Prior to Jan 1, 1982~No~DISCN~AMERICAN ANTIBIOTICS
LLC
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~AUROBINDO PHARMA~EQ 25
0MG BASE~A~065435~001~AB~Apr 29, 2008~No~RX~AUROBINDO PHARMA LTD
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~AUROBINDO PHARMA~EQ 50
0MG BASE~A~065435~002~AB~Apr 29, 2008~No~RX~AUROBINDO PHARMA LTD
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~DAVA PHARMS INC~EQ 250
MG BASE~A~062936~001~AB~Nov 25, 1988~No~RX~DAVA PHARMACEUTICALS INC
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~DAVA PHARMS INC~EQ 500
MG BASE~A~062935~001~AB~Nov 23, 1988~No~RX~DAVA PHARMACEUTICALS INC
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~HIKMA PHARMS~EQ 250MG
BASE~A~090549~001~AB~Oct 11, 2013~No~RX~HIKMA PHARMACEUTICALS
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~HIKMA PHARMS~EQ 500MG
BASE~A~090549~002~AB~Oct 11, 2013~No~RX~HIKMA PHARMACEUTICALS
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~IVAX SUB TEVA PHARMS~E
Q 125MG BASE~A~060518~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEU

PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~MYLAN~EQ 250MG BASE~A~
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~MYLAN~EQ 500MG BASE~A~
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~PUREPAC PHARM~EQ 125MG
BASE~A~061571~001~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICA
L CO
L CO
L CO
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~SANDOZ~EQ 250MG BASE~A
~064071~001~AB~Nov 30, 1995~No~RX~SANDOZ INC
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN V POTASSIUM~SANDOZ~EQ 500MG BASE~A
~064071~002~AB~Nov 30, 1995~Yes~RX~SANDOZ INC
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN-VK~TEVA~EQ 250MG BASE~A~060711~002
~AB~Approved Prior to Jan 1, 1982~No~RX~TEVA PHARMACEUTICALS USA INC
PENICILLIN V POTASSIUM~TABLET;ORAL~PENICILLIN-VK~TEVA~EQ 500MG BASE~A~060711~003
~AB~Approved Prior to Jan 1, 1982~No~RX~TEVA PHARMACEUTICALS USA INC
PENICILLIN G POTASSIUM~TABLET;ORAL~PENTIDS '200'~APOTHECON~200,000 UNITS~A~06215
5~001~~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON SUB BRISTOL MYERS SQUIBB
CO
CO
CO
CO
CO
CO
PENTOBARBITAL SODIUM~TABLET;ORAL~PENTOBARBITAL SODIUM~VITARINE~100MG~A~083285~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
FAMOTIDINE~TABLET;ORAL~PEPCID~VALEANT PHARMS NORTH~20MG~N~019462~001~AB~Oct 15,
1986~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
FAMOTIDINE~TABLET;ORAL~PEPCID~VALEANT PHARMS NORTH~40MG~N~019462~002~AB~Oct 15,
1986~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
FAMOTIDINE~TABLET;ORAL~PEPCID AC~MCNEIL CONS~10MG~N~020325~001~~Apr 28, 1995~No~
OTC~MCNEIL CONSUMER HEALTHCARE
FAMOTIDINE~TABLET;ORAL~PEPCID AC~MCNEIL CONS~20MG~N~020325~002~~Sep 23, 2003~Yes
~OTC~MCNEIL CONSUMER HEALTHCARE
FAMOTIDINE~TABLET;ORAL~PEPCID AC ~MCNEIL CONS~10MG~N~020902~001~~Aug 5, 1999~No~
OTC~MCNEIL CONSUMER HEALTHCARE
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~PERCOCET~VINTAGE PHARMS LLC~3
25MG;2.5MG~A~040330~001~AA~Jun 25, 1999~Yes~RX~VINTAGE PHARMACEUTICALS LLC
25MG;5MG~A~040330~002~AA~Jun 25, 1999~Yes~RX~VINTAGE PHARMACEUTICALS LLC

25MG;5MG~A~085106~002~~Approved Prior to Jan 1, 1982~No~DISCN~VINTAGE PHARMACEUT
ICALS LLC
25MG;7.5MG~A~040434~001~AA~Nov 23, 2001~Yes~RX~VINTAGE PHARMACEUTICALS LLC
25MG;10MG~A~040434~002~AA~Nov 23, 2001~Yes~RX~VINTAGE PHARMACEUTICALS LLC
00MG;7.5MG~A~040341~001~~Jul 26, 1999~No~DISCN~VINTAGE PHARMACEUTICALS LLC
50MG;10MG~A~040341~002~~Jul 26, 1999~No~DISCN~VINTAGE PHARMACEUTICALS LLC
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE~TABLET;ORAL~PERCODAN~E
NDO PHARMS~325MG;4.5MG;0.38MG~N~007337~006~~Approved Prior to Jan 1, 1982~No~DIS
CN~ENDO PHARMACEUTICALS INC
ASPIRIN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~PERCODAN~ENDO PHARMS~325MG;4.8355MG
~N~007337~007~AA~Aug 5, 2005~Yes~RX~ENDO PHARMACEUTICALS INC
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE~TABLET;ORAL~PERCODAN-D
EMI~ENDO PHARMS~325MG;2.25MG;0.19MG~N~007337~005~~Approved Prior to Jan 1, 1982~
No~DISCN~ENDO PHARMACEUTICALS INC
PERGOLIDE MESYLATE~TABLET;ORAL~PERGOLIDE MESYLATE~IVAX SUB TEVA PHARMS~EQ 0.05MG
BASE~A~076094~001~~Sep 4, 2003~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
PERGOLIDE MESYLATE~TABLET;ORAL~PERGOLIDE MESYLATE~IVAX SUB TEVA PHARMS~EQ 0.25MG
BASE~A~076094~002~~Sep 4, 2003~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARM
ACEUTICALS USA
PERGOLIDE MESYLATE~TABLET;ORAL~PERGOLIDE MESYLATE~IVAX SUB TEVA PHARMS~EQ 1MG BA
SE~A~076094~003~~Sep 4, 2003~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACE
UTICALS USA
PERGOLIDE MESYLATE~TABLET;ORAL~PERGOLIDE MESYLATE~PAR PHARM~EQ 0.05MG BASE~A~076
061~001~~Nov 27, 2002~No~DISCN~PAR PHARMACEUTICAL
PERGOLIDE MESYLATE~TABLET;ORAL~PERGOLIDE MESYLATE~PAR PHARM~EQ 0.25MG BASE~A~076
061~002~~Nov 27, 2002~No~DISCN~PAR PHARMACEUTICAL
PERGOLIDE MESYLATE~TABLET;ORAL~PERGOLIDE MESYLATE~PAR PHARM~EQ 1MG BASE~A~076061
~003~~Nov 27, 2002~No~DISCN~PAR PHARMACEUTICAL
CYPROHEPTADINE HYDROCHLORIDE~TABLET;ORAL~PERIACTIN~MERCK~4MG~N~012649~001~~Appro
PERINDOPRIL ERBUMINE~TABLET;ORAL~PERINDOPRIL ERBUMINE~ANI PHARMS INC~2MG~A~07813
PERINDOPRIL ERBUMINE~TABLET;ORAL~PERINDOPRIL ERBUMINE~APOTEX~2MG~A~090463~001~AB
PERINDOPRIL ERBUMINE~TABLET;ORAL~PERINDOPRIL ERBUMINE~AUROBINDO PHARMA~2MG~A~079
070~001~AB~Nov 10, 2009~No~RX~AUROBINDO PHARMA LTD
PERINDOPRIL ERBUMINE~TABLET;ORAL~PERINDOPRIL ERBUMINE~LUPIN LTD~2MG~A~078263~001
~AB~Jan 27, 2010~No~RX~LUPIN LTD
PERINDOPRIL ERBUMINE~TABLET;ORAL~PERINDOPRIL ERBUMINE~ROXANE~2MG~A~090072~001~AB

~Nov 10, 2009~No~RX~ROXANE LABORATORIES INC
DOXYCYCLINE HYCLATE~TABLET;ORAL~PERIOSTAT~GALDERMA LABS LP~EQ 20MG BASE **Federa
ty or efficacy reasons**~N~050783~001~~Feb 2, 2001~No~DISCN~GALDERMA LABORATORIE
S LP
PERGOLIDE MESYLATE~TABLET;ORAL~PERMAX~VALEANT PHARM INTL~EQ 0.05MG BASE~N~019385
~001~~Dec 30, 1988~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
PERGOLIDE MESYLATE~TABLET;ORAL~PERMAX~VALEANT PHARM INTL~EQ 0.25MG BASE~N~019385
~002~~Dec 30, 1988~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
PERGOLIDE MESYLATE~TABLET;ORAL~PERMAX~VALEANT PHARM INTL~EQ 1MG BASE~N~019385~00
3~~Dec 30, 1988~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~PERMITIL~SCHERING~0.25MG~N~012034~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~PERMITIL~SCHERING~2.5MG~N~012034~004~~App
roved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~PERMITIL~SCHERING~5MG~N~012034~005~~Appro
ved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~PERMITIL~SCHERING~10MG~N~012034~006~~Appr
oved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
PERPHENAZINE~TABLET;ORAL~PERPHENAZINE~ANI PHARMS INC~8MG~A~089456~001~~Sep 10, 1
PERPHENAZINE~TABLET;ORAL~PERPHENAZINE~SANDOZ~2MG~A~089683~001~AB~Dec 8, 1988~No~
RX~SANDOZ INC
RX~SANDOZ INC
RX~SANDOZ INC
PERPHENAZINE~TABLET;ORAL~PERPHENAZINE~SANDOZ~16MG~A~089686~001~AB~Dec 8, 1988~Ye
s~RX~SANDOZ INC
PERPHENAZINE~TABLET;ORAL~PERPHENAZINE~TEVA PHARMS USA~2MG~A~089707~001~~Sep 10,
PERPHENAZINE~TABLET;ORAL~PERPHENAZINE~VINTAGE PHARMS~2MG~A~040226~001~AB~Dec 31,
PERPHENAZINE~TABLET;ORAL~PERPHENAZINE~VINTAGE PHARMS~16MG~A~040226~004~AB~Dec 31
, 1998~No~RX~VINTAGE PHARMACEUTICALS INC
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE~TABLET;ORAL~PERPHENAZINE AND AMITRIPTY
LINE HYDROCHLORIDE~IVAX SUB TEVA PHARMS~10MG;2MG~A~070935~001~~Sep 11, 1986~No~D

LINE HYDROCHLORIDE~MUTUAL PHARM~10MG;2MG~A~071077~001~~Nov 12, 1986~No~DISCN~MUT
UAL PHARMACEUTICAL CO INC
LINE HYDROCHLORIDE~MYLAN~10MG;2MG~A~071443~002~~Nov 10, 1988~No~RX~MYLAN PHARMAC
EUTICALS INC
LINE HYDROCHLORIDE~MYLAN~10MG;4MG~A~071443~003~~Nov 10, 1988~No~RX~MYLAN PHARMAC
EUTICALS INC
LINE HYDROCHLORIDE~MYLAN~25MG;2MG~A~071443~004~~Nov 10, 1988~Yes~RX~MYLAN PHARMA
CEUTICALS INC
CEUTICALS INC
CEUTICALS INC
LINE HYDROCHLORIDE~PAR PHARM~10MG;2MG~A~070565~001~~Sep 11, 1986~No~DISCN~PAR PH
ARMACEUTICAL INC
ARMACEUTICAL INC
ARMACEUTICAL INC
ARMACEUTICAL INC
ARMACEUTICAL INC
LINE HYDROCHLORIDE~SANDOZ~10MG;2MG~A~071062~001~~Nov 27, 1987~No~DISCN~SANDOZ IN
C
LINE HYDROCHLORIDE~SANDOZ~10MG;4MG~A~071862~001~~Dec 21, 1987~No~DISCN~SANDOZ IN
C
C
C
LINE HYDROCHLORIDE~SANDOZ~50MG;4MG~A~071863~001~~Dec 21, 1987~No~DISCN~SANDOZ IN
C

LINE HYDROCHLORIDE~WATSON LABS~10MG;2MG~A~070373~001~~Aug 25, 1986~No~DISCN~WATS
ON LABORATORIES INC
LINE HYDROCHLORIDE~WATSON LABS~10MG;2MG~A~072539~001~~Feb 15, 1989~No~DISCN~WATS
ON LABORATORIES INC
LINE HYDROCHLORIDE~WATSON LABS~10MG;2MG~A~073007~001~~Oct 17, 1991~No~DISCN~WATS
ON LABORATORIES INC
ON LABORATORIES INC
ON LABORATORIES INC
ON LABORATORIES INC
ON LABORATORIES INC
ON LABORATORIES INC
ON LABORATORIES INC
ON LABORATORIES INC
ON LABORATORIES INC
ON LABORATORIES INC
LINE HYDROCHLORIDE~WATSON LABS~50MG;4MG~A~070377~001~~Nov 4, 1986~No~DISCN~WATSO
N LABORATORIES INC
LINE HYDROCHLORIDE~WATSON LABS~50MG;4MG~A~071558~001~~Mar 2, 1987~No~DISCN~WATSO
N LABORATORIES INC
ON LABORATORIES INC
DIPYRIDAMOLE~TABLET;ORAL~PERSANTINE~BOEHRINGER INGELHEIM~25MG~N~012836~003~AB~De
c 22, 1986~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
DIPYRIDAMOLE~TABLET;ORAL~PERSANTINE~BOEHRINGER INGELHEIM~50MG~N~012836~004~AB~Fe
b 6, 1987~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
DIPYRIDAMOLE~TABLET;ORAL~PERSANTINE~BOEHRINGER INGELHEIM~75MG~N~012836~005~AB~Fe
b 6, 1987~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTICALS INC
PAROXETINE MESYLATE~TABLET;ORAL~PEXEVA~NOVEN THERAP~EQ 10MG BASE~N~021299~001~~J
ul 3, 2003~No~RX~NOVEN THERAPEUTICS LLC
ul 3, 2003~Yes~RX~NOVEN THERAPEUTICS LLC
ERYTHROMYCIN STEARATE~TABLET;ORAL~PFIZER-E~PFIZER~EQ 250MG BASE~A~061791~001~~Ap

ERYTHROMYCIN STEARATE~TABLET;ORAL~PFIZER-E~PFIZER~EQ 500MG BASE~A~061791~002~~Ap
PENICILLIN G POTASSIUM~TABLET;ORAL~PFIZERPEN G~PFIZER~50,000 UNITS~A~060075~001~
~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
PENICILLIN G POTASSIUM~TABLET;ORAL~PFIZERPEN G~PFIZER~100,000 UNITS~A~060075~002
PENICILLIN V POTASSIUM~TABLET;ORAL~PFIZERPEN VK~PFIZER~EQ 250MG BASE~A~061836~00
PENICILLIN V POTASSIUM~TABLET;ORAL~PFIZERPEN VK~PFIZER~EQ 500MG BASE~A~061836~00
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~PHENAPHEN-650 W/ CODEINE~ROBINS AH~
650MG;30MG~A~085856~001~~Approved Prior to Jan 1, 1982~No~DISCN~AH ROBINS CO
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENAZINE~MAST MM~35MG~A~087305~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~MM MAST AND CO
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENAZINE-35~ABC HOLDING~35MG~A~085512~001~
~Approved Prior to Jan 1, 1982~No~DISCN~ABC HOLDING CORP
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~BARR~35MG~A~083644
~001~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~ELITE LABS INC~35M
G~A~040762~001~AA~Jan 28, 2008~No~RX~ELITE LABORATORIES INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~FERNDALE LABS~35MG
~A~086834~001~~Sep 15, 1983~No~DISCN~FERNDALE LABORATORIES INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~INWOOD LABS~35MG~A
~084740~001~~Approved Prior to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB
FOREST LABORATORIES INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~IVAX PHARMS~35MG~A
~085611~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~IVAX PHARMS~35MG~A
~085612~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~IVAX SUB TEVA PHAR
MS~35MG~A~083682~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICAL

PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~KV PHARM~35MG~A~08
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~KVK TECH~35MG~A~09
1042~001~AA~Aug 31, 2010~No~RX~KVK TECH INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~MFG CHEMISTS~35MG~
A~085914~001~~Approved Prior to Jan 1, 1982~No~DISCN~MANUFACTURING CHEMISTS INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~MIKART~35MG~A~0894
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~NEXGEN PHARMA INC~
35MG~A~086020~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~NUMARK~35MG~A~0837
90~001~~Approved Prior to Jan 1, 1982~No~DISCN~NUMARK LABORATORIES INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~PVT FORM~35MG~A~08
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~PVT FORM~35MG~A~08
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~SANDOZ~35MG~A~0854
88~001~AA~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~SOLVAY~35MG~A~0839
93~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~TG UNITED LABS~35M
G~A~085761~001~~Approved Prior to Jan 1, 1982~No~DISCN~TG UNITED LABS LLC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~TG UNITED LABS~35M
G~A~085941~001~~Jun 27, 1983~No~DISCN~TG UNITED LABS LLC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~USL PHARMA~35MG~A~
083805~001~~Approved Prior to Jan 1, 1982~No~DISCN~USL PHARMA INC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~VITARINE~35MG~A~08
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PHENDIMETRAZINE TARTRATE~WATSON LABS~35MG~A
PHENELZINE SULFATE~TABLET;ORAL~PHENELZINE SULFATE~NOVEL LABS INC~EQ 15MG BASE~A~

200181~001~AB~Dec 8, 2010~No~RX~NOVEL LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PHENERGAN~DELCOR ASSET CORP~12.5MG~N~0079
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PHENERGAN~DELCOR ASSET CORP~25MG~N~007935
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PHENERGAN~DELCOR ASSET CORP~50MG~N~007935
CHLORPHENIRAMINE MALEATE~TABLET;ORAL~PHENETRON~LANNETT~4MG~A~080846~001~~Approve
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~ABLE~37.5MG~A~04
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~ACTAVIS ELIZABET
H~37.5MG~A~040276~001~~Nov 25, 1998~No~DISCN~ACTAVIS ELIZABETH LLC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~AUROLIFE PHARMA
LLC~37.5MG~A~203068~001~AA~Aug 6, 2014~No~RX~AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~BARR~37.5MG~A~09
0470~001~AA~Aug 31, 2009~No~RX~BARR LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~ELITE LABS~37.5M
G~A~200272~001~AA~Jan 31, 2011~No~RX~ELITE LABORATORIES INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~INVAGEN PHARMS~3
7.5MG~A~202942~001~AA~Feb 5, 2014~No~RX~INVAGEN PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~IVAX PHARMS~8MG~
A~085553~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~KEN LIFESCIENCE~
37.5MG~A~205008~001~AA~Sep 25, 2014~No~RX~KEN LIFESCIENCE
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~KVK TECH~37.5MG~
A~040876~001~AA~Mar 31, 2008~No~RX~KVK TECH INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~LANNETT~37.5MG~A
~040555~001~AA~Apr 15, 2005~No~RX~LANNETT CO INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~MIKAH PHARMA~37.
5MG~A~040190~001~AA~May 30, 1997~No~RX~MIKAH PHARMA LLC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~MIRROR PHARMS~37
.5MG~A~091451~001~AA~Sep 21, 2012~No~RX~MIRROR PHARMACEUTICALS LLC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~MUTUAL PHARM~37.
5MG~A~040526~001~AA~Oct 23, 2003~No~RX~MUTUAL PHARMACEUTICAL CO INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~SANDOZ~8MG~A~085
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~SANDOZ~8MG~A~085
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~SANDOZ INC~30MG~
A~088605~001~~Sep 28, 1987~No~DISCN~SANDOZ INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~SUN PHARM INDS I
NC~37.5MG~A~040790~001~AA~Aug 21, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~TG UNITED LABS~8
MG~A~083923~001~~Approved Prior to Jan 1, 1982~No~DISCN~TG UNITED LABS LLC
MG~A~085319~001~~Approved Prior to Jan 1, 1982~No~DISCN~TG UNITED LABS LLC
7.5MG~A~088596~001~~Apr 4, 1984~No~DISCN~TG UNITED LABS LLC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~USL PHARMA~8MG~A
~083804~001~~Approved Prior to Jan 1, 1982~No~DISCN~USL PHARMA INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~USL PHARMA~37.5M
G~A~088910~001~~Jul 17, 1985~No~DISCN~USL PHARMA INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~USL PHARMA~37.5M
G~A~088917~001~~Jul 17, 1985~No~DISCN~USL PHARMA INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~VINTAGE PHARMS~3
7.5MG~A~040377~001~AA~Jan 4, 2002~No~RX~VINTAGE PHARMACEUTICALS INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~VITARINE~8MG~A~0

PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~VITARINE~8MG~A~0
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PHENTERMINE HYDROCHLORIDE~WATSON LABS~8MG~
A~085739~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
PHENACEMIDE~TABLET;ORAL~PHENURONE~ABBVIE~500MG **Federal Register determination
N~007707~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBVIE INC
PHENYL AMINOSALICYLATE~TABLET;ORAL~PHENY-PAS-TEBAMIN~PHARM RES ASSOC~500MG~N~011
695~003~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACEUTICAL RESEARCH ASSOC IN
C
PHENYLBUTAZONE~TABLET;ORAL~PHENYLBUTAZONE~MUTUAL PHARM~100MG~A~088863~001~~Dec 4
PHENYLBUTAZONE~TABLET;ORAL~PHENYLBUTAZONE~SANDOZ~100MG~A~084339~001~~Approved Pr
PHENYLBUTAZONE~TABLET;ORAL~PHENYLBUTAZONE~WATSON LABS~100MG~A~086151~001~~Approv
PHENYLBUTAZONE~TABLET;ORAL~PHENYLBUTAZONE~WATSON LABS~100MG~A~087674~001~~Apr 21
CALCIUM ACETATE~TABLET;ORAL~PHOSLO~FRESENIUS MEDCL~EQ 169MG CALCIUM~N~019976~001
~~Dec 10, 1990~No~DISCN~FRESENIUS MEDICAL CARE NORTH AMERICA
ACETAMINOPHEN; BUTALBITAL~TABLET;ORAL~PHRENILIN~VALEANT~325MG;50MG~A~087811~001~
~Jun 19, 1985~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~PILOCARPINE HYDROCHLORIDE~COREPHARMA~5MG~A
~076746~001~AB~Nov 16, 2004~No~RX~COREPHARMA LLC
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~PILOCARPINE HYDROCHLORIDE~IMPAX LABS~5MG~A
~077248~001~AB~Mar 31, 2006~No~RX~IMPAX LABORATORIES INC
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~PILOCARPINE HYDROCHLORIDE~IMPAX LABS~7.5MG
~A~077248~002~AB~Mar 31, 2006~No~RX~IMPAX LABORATORIES INC
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~PILOCARPINE HYDROCHLORIDE~LANNETT~5MG~A~07
7220~001~AB~Oct 14, 2005~No~RX~LANNETT HOLDINGS INC
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~PILOCARPINE HYDROCHLORIDE~LANNETT~7.5MG~A~
077220~002~AB~May 6, 2009~No~RX~LANNETT HOLDINGS INC
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~PILOCARPINE HYDROCHLORIDE~ROXANE~5MG~A~076
963~001~AB~Dec 22, 2004~No~RX~ROXANE LABORATORIES INC
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~PILOCARPINE HYDROCHLORIDE~ROXANE~7.5MG~A~0
76963~002~AB~Feb 27, 2007~No~RX~ROXANE LABORATORIES INC
PINDOLOL~TABLET;ORAL~PINDOLOL~IVAX SUB TEVA PHARMS~5MG~A~073687~001~~Feb 26, 199
PINDOLOL~TABLET;ORAL~PINDOLOL~IVAX SUB TEVA PHARMS~10MG~A~073687~002~~Feb 26, 19
PINDOLOL~TABLET;ORAL~PINDOLOL~MUTUAL PHARM~5MG~A~074063~001~AB~Jan 27, 1994~No~R
X~MUTUAL PHARMACEUTICAL CO INC
PINDOLOL~TABLET;ORAL~PINDOLOL~MUTUAL PHARM~10MG~A~074063~002~AB~Jan 27, 1994~No~
PINDOLOL~TABLET;ORAL~PINDOLOL~MYLAN PHARMS INC~5MG~A~074013~001~~Sep 24, 1992~No
~DISCN~MYLAN PHARMACEUTICALS INC
PINDOLOL~TABLET;ORAL~PINDOLOL~MYLAN PHARMS INC~5MG~A~074019~001~AB~Sep 3, 1992~N
PINDOLOL~TABLET;ORAL~PINDOLOL~MYLAN PHARMS INC~10MG~A~074018~001~~Sep 24, 1992~N
PINDOLOL~TABLET;ORAL~PINDOLOL~MYLAN PHARMS INC~10MG~A~074019~002~AB~Sep 3, 1992~
Yes~RX~MYLAN PHARMACEUTICALS INC
PINDOLOL~TABLET;ORAL~PINDOLOL~NOSTRUM LABS~5MG~A~074474~001~~Oct 28, 1996~No~DIS
CN~NOSTRUM LABORATORIES INC
PINDOLOL~TABLET;ORAL~PINDOLOL~NOSTRUM LABS~10MG~A~074474~002~~Oct 28, 1996~No~DI
SCN~NOSTRUM LABORATORIES INC
PINDOLOL~TABLET;ORAL~PINDOLOL~PUREPAC PHARM~5MG~A~074125~001~~Apr 28, 1993~No~DI
SCN~PUREPAC PHARMACEUTICAL CO
PINDOLOL~TABLET;ORAL~PINDOLOL~PUREPAC PHARM~10MG~A~074125~002~~Apr 28, 1993~No~D

ISCN~PUREPAC PHARMACEUTICAL CO
PINDOLOL~TABLET;ORAL~PINDOLOL~SANDOZ~5MG~A~073608~001~~Mar 29, 1993~No~DISCN~SAN
DOZ INC
PINDOLOL~TABLET;ORAL~PINDOLOL~SANDOZ~10MG~A~073609~001~~Mar 29, 1993~No~DISCN~SA
NDOZ INC
PINDOLOL~TABLET;ORAL~PINDOLOL~TEVA~5MG~A~073661~001~~Oct 31, 1993~No~DISCN~TEVA
PINDOLOL~TABLET;ORAL~PINDOLOL~TEVA~5MG~A~074123~001~~Apr 17, 1997~No~DISCN~TEVA
PINDOLOL~TABLET;ORAL~PINDOLOL~TEVA~10MG~A~073661~002~~Oct 31, 1993~No~DISCN~TEVA
PINDOLOL~TABLET;ORAL~PINDOLOL~TEVA~10MG~A~074123~002~~Apr 17, 1997~No~DISCN~TEVA
PINDOLOL~TABLET;ORAL~PINDOLOL~WATSON LABS~5MG~A~074437~001~~Feb 27, 1995~No~DISC
PINDOLOL~TABLET;ORAL~PINDOLOL~WATSON LABS~10MG~A~074437~002~~Feb 27, 1995~No~DIS
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~ACCORD HLTHCAR
E~EQ 15MG BASE~A~200044~001~AB~Feb 13, 2013~No~RX~ACCORD HEALTHCARE INC
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~AUROBINDO PHAR
MA LTD~EQ 15MG BASE~A~200268~001~AB~Feb 13, 2013~No~RX~AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~BRECKENRIDGE P
HARM~EQ 15MG BASE~A~078472~001~AB~Feb 13, 2013~No~RX~BRECKENRIDGE PHARMACEUTICAL
INC
INC
INC
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~DR REDDYS LABS
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~LUPIN LTD~EQ 1
5MG BASE~A~204133~001~AB~Apr 7, 2014~No~RX~LUPIN LTD
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~MACLEODS PHARM
S LTD~EQ 15MG BASE~A~202467~001~AB~Feb 6, 2013~No~RX~MACLEODS PHARMACEUTICALS LT
D
D
D
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~MYLAN PHARMS I

NC~EQ 15MG BASE~A~076801~001~AB~Aug 17, 2012~No~RX~MYLAN PHARMACEUTICALS INC
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~SANDOZ~EQ 15MG
BASE~A~078670~001~AB~Feb 13, 2013~No~RX~SANDOZ INC
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~TEVA PHARMS US
A~EQ 15MG BASE~A~077210~001~AB~Jan 10, 2014~No~RX~TEVA PHARMACEUTICALS USA
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~TORRENT PHARMS
LTD~EQ 15MG BASE~A~091298~001~AB~Feb 13, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~WATSON LABS~EQ
15MG BASE~A~076798~001~AB~Oct 26, 2012~No~RX~WATSON LABORATORIES
PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE~ZYDUS PHARMS U
SA INC~EQ 15MG BASE~A~202456~001~AB~Feb 13, 2013~No~RX~ZYDUS PHARMACEUTICALS USA
INC
INC
INC
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE A
ND GLIMEPIRIDE~SANDOZ~2MG;30MG~A~201049~001~AB~Jan 4, 2013~No~RX~SANDOZ INC
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYDROCHLORIDE A
ND GLIMEPIRIDE~SANDOZ~4MG;30MG~A~201049~002~AB~Jan 4, 2013~No~RX~SANDOZ INC
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE~TABLET;ORAL~PIOGLITAZONE HYD
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~AUROBINDO PHARMA LTD~500MG;EQ 15MG BASE~A
~200823~001~AB~Feb 13, 2013~No~RX~AUROBINDO PHARMA LTD
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~AUROBINDO PHARMA LTD~850MG;EQ 15MG BASE~A
~200823~002~AB~Feb 13, 2013~No~RX~AUROBINDO PHARMA LTD
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~MYLAN~500MG;EQ 15MG BASE~A~090406~001~AB~
Feb 25, 2011~No~RX~MYLAN PHARMACEUTICALS INC
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~MYLAN~850MG;EQ 15MG BASE~A~090406~002~AB~
Feb 25, 2011~No~RX~MYLAN PHARMACEUTICALS INC
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~SANDOZ~500MG;EQ 15MG BASE~A~091273~001~AB
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~SANDOZ~850MG;EQ 15MG BASE~A~091273~002~AB

ROCHLORIDE AND METFORMIN HYDROCHLORIDE~TEVA PHARMS USA~500MG;EQ 15MG BASE~A~0911
55~001~AB~Mar 10, 2014~No~RX~TEVA PHARMACEUTICALS USA
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~TEVA PHARMS USA~850MG;EQ 15MG BASE~A~0911
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~TORRENT PHARMS LTD~500MG;EQ 15MG BASE~A~2
02001~001~AB~Feb 13, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
ROCHLORIDE AND METFORMIN HYDROCHLORIDE~TORRENT PHARMS LTD~850MG;EQ 15MG BASE~A~2
02001~002~AB~Feb 13, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
PIPERAZINE CITRATE~TABLET;ORAL~PIPERAZINE CITRATE~IMPAX LABS~EQ 250MG BASE~A~080
LEVONORGESTREL~TABLET;ORAL~PLAN B~TEVA BRANDED PHARM~0.75MG~N~021045~001~~Jul 28
, 1999~No~DISCN~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
LEVONORGESTREL~TABLET;ORAL~PLAN B~TEVA BRANDED PHARM~0.75MG~N~021045~002~~Aug 24
, 2006~Yes~OTC~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
LEVONORGESTREL~TABLET;ORAL~PLAN B~TEVA BRANDED PHARM~0.75MG~N~021045~002~AB~Aug
24, 2006~Yes~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
LEVONORGESTREL~TABLET;ORAL~PLAN B ONE-STEP~TEVA BRANDED PHARM~1.5MG~N~021998~001
~~Jul 10, 2009~Yes~OTC~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
HYDROXYCHLOROQUINE SULFATE~TABLET;ORAL~PLAQUENIL~SANOFI AVENTIS US~200MG~N~00976
8~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
CLOPIDOGREL BISULFATE~TABLET;ORAL~PLAVIX~SANOFI AVENTIS US~EQ 75MG BASE~N~020839
~001~AB~Nov 17, 1997~No~RX~SANOFI AVENTIS US LLC
CLOPIDOGREL BISULFATE~TABLET;ORAL~PLAVIX~SANOFI AVENTIS US~EQ 300MG BASE~N~02083
9~002~AB~Sep 20, 2007~Yes~RX~SANOFI AVENTIS US LLC
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~PLEGINE~WYETH AYERST~35MG~N~012248~001~~App
roved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
CILOSTAZOL~TABLET;ORAL~PLETAL~OTSUKA~50MG~N~020863~001~AB~Jan 15, 1999~Yes~RX~OT
CILOSTAZOL~TABLET;ORAL~PLETAL~OTSUKA~100MG~N~020863~002~AB~Jan 15, 1999~Yes~RX~O
TSUKA PHARMACEUTICAL CO LTD
ESTROGENS, CONJUGATED; MEPROBAMATE~TABLET;ORAL~PMB 200~WYETH AYERST~0.45MG;200MG
ESTROGENS, CONJUGATED; MEPROBAMATE~TABLET;ORAL~PMB 400~WYETH AYERST~0.45MG;400MG
DEXCHLORPHENIRAMINE MALEATE~TABLET;ORAL~POLARAMINE~SCHERING~2MG~A~086835~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
EZOGABINE~TABLET;ORAL~POTIGA~GLAXOSMITHKLINE~50MG~N~022345~001~~Jun 10, 2011~No~
RX~GLAXOSMITHKLINE
EZOGABINE~TABLET;ORAL~POTIGA~GLAXOSMITHKLINE~200MG~N~022345~002~~Jun 10, 2011~No
~RX~GLAXOSMITHKLINE
EZOGABINE~TABLET;ORAL~POTIGA~GLAXOSMITHKLINE~300MG~N~022345~003~~Jun 10, 2011~No
~RX~GLAXOSMITHKLINE
EZOGABINE~TABLET;ORAL~POTIGA~GLAXOSMITHKLINE~400MG~N~022345~004~~Jun 10, 2011~Ye
s~RX~GLAXOSMITHKLINE
PYRVINIUM PAMOATE~TABLET;ORAL~POVAN~PARKE DAVIS~EQ 50MG BASE~N~012485~002~~Appro
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~PRAMINE~ALRA~10MG~A~083827~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~ALRA LABORATORIES INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~ACTAVIS GRP
PTC~0.125MG~A~091254~001~AB~Nov 30, 2010~No~RX~ACTAVIS GROUP PTC EHF

PTC~1MG~A~091254~005~AB~Nov 30, 2010~No~RX~ACTAVIS GROUP PTC EHF
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~ALEMBIC LTD~
0.125MG~A~078894~001~AB~Oct 8, 2010~No~RX~ALEMBIC LTD
1MG~A~078894~004~AB~Oct 8, 2010~No~RX~ALEMBIC LTD
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~APOTEX INC~0
.125MG~A~090151~001~AB~Apr 30, 2012~No~RX~APOTEX INC
MG~A~090151~004~AB~Apr 30, 2012~No~RX~APOTEX INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~AUROBINDO PH
ARMA LTD~0.125MG~A~202633~001~AB~Oct 26, 2012~No~RX~AUROBINDO PHARMA LTD
ARMA LTD~1MG~A~202633~005~AB~Oct 26, 2012~No~RX~AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~BARR~0.125MG
~A~077724~001~AB~Feb 19, 2008~No~RX~BARR LABORATORIES INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~BARR~0.25MG~
A~077724~002~AB~Feb 19, 2008~No~RX~BARR LABORATORIES INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~BARR~0.5MG~A
~077724~003~AB~Feb 19, 2008~No~RX~BARR LABORATORIES INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~BARR~1MG~A~0
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~BARR~1.5MG~A
~077724~005~AB~Feb 19, 2008~No~RX~BARR LABORATORIES INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~BRECKENRIDGE
PHARM~0.125MG~A~091450~001~AB~Oct 8, 2010~No~RX~BRECKENRIDGE PHARMACEUTICAL INC
PHARM~1MG~A~091450~004~AB~Oct 8, 2010~No~RX~BRECKENRIDGE PHARMACEUTICAL INC

PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~GLENMARK GEN
ERICS~0.125MG~A~090781~001~AB~Oct 8, 2010~No~RX~GLENMARK GENERICS LTD INDIA
ERICS~1MG~A~090781~004~AB~Oct 8, 2010~No~RX~GLENMARK GENERICS LTD INDIA
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~MACLEODS PHA
RMS LTD~0.125MG~A~202164~001~AB~Sep 20, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
RMS LTD~1MG~A~202164~004~AB~Sep 20, 2012~No~RX~MACLEODS PHARMACEUTICALS LTD
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~MYLAN~0.125M
G~A~077854~001~AB~Oct 8, 2010~No~RX~MYLAN PHARMACEUTICALS INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~MYLAN~0.25MG
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~MYLAN~0.5MG~
A~077854~003~AB~Oct 8, 2010~No~RX~MYLAN PHARMACEUTICALS INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~MYLAN~0.75MG
~A~090764~001~AB~Apr 9, 2010~No~RX~MYLAN PHARMACEUTICALS INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~MYLAN~1MG~A~
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~MYLAN~1.5MG~
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~SANDOZ~0.125
MG~A~090190~001~AB~Jul 6, 2010~No~RX~SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~SANDOZ~0.25M
G~A~090190~002~AB~Jul 6, 2010~No~RX~SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~SANDOZ~0.5MG
~A~090190~003~AB~Jul 6, 2010~No~RX~SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~SANDOZ~0.75M
G~A~090190~006~AB~Oct 8, 2010~No~RX~SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~SANDOZ~1MG~A
~090190~004~AB~Jul 6, 2010~No~RX~SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~SANDOZ~1.5MG
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~SCIEGEN PHAR
MS INC~0.125MG~A~203855~001~AB~Oct 28, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
MS INC~1MG~A~203855~005~AB~Oct 28, 2014~No~RX~SCIEGEN PHARMACEUTICALS INC
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~STRIDES PHAR
MA~0.125MG~A~202702~001~AB~Jun 3, 2014~No~RX~STRIDES PHARMA GLOBAL PTE LTD

MA~1MG~A~202702~005~AB~Jun 3, 2014~No~RX~STRIDES PHARMA GLOBAL PTE LTD
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~SUN PHARM IN
DS INC~0.125MG~A~091683~001~AB~Mar 27, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES
INC
DS INC~0.25MG~A~091683~002~AB~Mar 27, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES I
NC
DS INC~0.5MG~A~091683~003~AB~Mar 27, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES IN
C
DS INC~0.75MG~A~091683~004~AB~Mar 27, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES I
NC
DS INC~1MG~A~091683~005~AB~Mar 27, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
DS INC~1.5MG~A~091683~006~AB~Mar 27, 2013~No~RX~SUN PHARMACEUTICAL INDUSTRIES IN
C
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~TEVA PHARMS~
0.125MG~A~090241~001~AB~Oct 8, 2010~No~RX~TEVA PHARMACEUTICALS USA
1MG~A~090241~005~AB~Oct 8, 2010~No~RX~TEVA PHARMACEUTICALS USA
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~TORRENT PHAR
MS~0.125MG~A~090865~001~AB~Oct 8, 2010~No~RX~TORRENT PHARMACEUTICALS LTD
MS~1MG~A~090865~005~AB~Oct 8, 2010~No~RX~TORRENT PHARMACEUTICALS LTD
PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~WATSON LABS~
0.125MG~A~078551~001~~Oct 8, 2010~No~DISCN~WATSON LABORATORIES INC
1MG~A~078551~004~~Oct 8, 2010~No~DISCN~WATSON LABORATORIES INC

PRAMIPEXOLE DIHYDROCHLORIDE~TABLET;ORAL~PRAMIPEXOLE DIHYDROCHLORIDE~ZYDUS PHARMS
USA INC~0.125MG~A~078920~001~AB~Jul 6, 2010~No~RX~ZYDUS PHARMACEUTICALS USA INC
USA INC~1MG~A~078920~004~AB~Jul 6, 2010~No~RX~ZYDUS PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE; REPAGLINIDE~TABLET;ORAL~PRANDIMET~NOVO NORDISK INC~500M
G;1MG~N~022386~001~~Jun 23, 2008~No~RX~NOVO NORDISK INC
METFORMIN HYDROCHLORIDE; REPAGLINIDE~TABLET;ORAL~PRANDIMET~NOVO NORDISK INC~500M
G;2MG~N~022386~002~~Jun 23, 2008~Yes~RX~NOVO NORDISK INC
REPAGLINIDE~TABLET;ORAL~PRANDIN~NOVO NORDISK INC~0.5MG~N~020741~001~AB~Dec 22, 1
997~No~RX~NOVO NORDISK INC
REPAGLINIDE~TABLET;ORAL~PRANDIN~NOVO NORDISK INC~1MG~N~020741~002~AB~Dec 22, 199
7~No~RX~NOVO NORDISK INC
REPAGLINIDE~TABLET;ORAL~PRANDIN~NOVO NORDISK INC~2MG~N~020741~003~AB~Dec 22, 199
7~Yes~RX~NOVO NORDISK INC
DIPHEMANIL METHYLSULFATE~TABLET;ORAL~PRANTAL~SCHERING~100MG~N~008114~004~~Approv
ed Prior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVACHOL~BRISTOL MYERS SQUIBB~10MG~N~019898~002~
~Oct 31, 1991~No~DISCN~BRISTOL MYERS SQUIBB
AB~Oct 31, 1991~No~RX~BRISTOL MYERS SQUIBB
AB~Mar 22, 1993~No~RX~BRISTOL MYERS SQUIBB
AB~Dec 18, 2001~Yes~RX~BRISTOL MYERS SQUIBB
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~APOTEX~10MG~A~076341~001~AB~Oc
t 23, 2006~No~RX~APOTEX CORP
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~APOTEX~80MG~A~076341~004~AB~De
c 28, 2007~No~RX~APOTEX CORP
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~CIPLA LTD~10MG~A~077904~001~AB
~Oct 23, 2006~No~RX~CIPLA LTD
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~DR REDDYS LABS INC~10MG~A~0767
14~001~AB~Oct 23, 2006~No~RX~DR REDDYS LABORATORIES INC
14~004~AB~Dec 28, 2007~No~RX~DR REDDYS LABORATORIES INC
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~GLENMARK GENERICS~10MG~A~07798
7~001~AB~May 11, 2007~No~RX~GLENMARK GENERICS LTD

PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~LUPIN PHARMS~10MG~A~077917~001
~AB~Jan 8, 2008~No~RX~LUPIN PHARMACEUTICALS INC
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~MYLAN~10MG~A~077013~001~AB~Oct
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~MYLAN~80MG~A~077013~004~AB~Dec
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~MYLAN PHARMS INC~10MG~A~079187
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~PLIVA HRVATSKA DOO~10MG~A~0777
30~001~~Nov 21, 2006~No~DISCN~PLIVA HRVATSKA DOO
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~RANBAXY LABS LTD~10MG~A~076445
~001~~Apr 23, 2007~No~DISCN~RANBAXY LABORATORIES LTD
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~SANDOZ~10MG~A~076397~003~AB~Oc
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~SANDOZ~80MG~A~077491~001~AB~Fe
b 11, 2008~No~RX~SANDOZ INC
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~TEVA~10MG~A~076056~001~AB~Apr
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~TEVA PHARMS~80MG~A~077793~001~
AB~Jan 15, 2008~No~RX~TEVA PHARMACEUTICALS USA
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~WATSON LABS~10MG~A~076939~004~

AB~Dec 28, 2007~No~RX~WATSON LABORATORIES INC
PRAVASTATIN SODIUM~TABLET;ORAL~PRAVASTATIN SODIUM~ZYDUS PHARMS USA~10MG~A~077751
~001~AB~Apr 30, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
CHLORPHENTERMINE HYDROCHLORIDE~TABLET;ORAL~PRE-SATE~PARKE DAVIS~EQ 65MG BASE~N~0
14696~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT
CO
ACARBOSE~TABLET;ORAL~PRECOSE~BAYER HLTHCARE~25MG~N~020482~004~AB~May 29, 1997~Ye
ACARBOSE~TABLET;ORAL~PRECOSE~BAYER HLTHCARE~50MG~N~020482~001~AB~Sep 6, 1995~No~
ACARBOSE~TABLET;ORAL~PRECOSE~BAYER HLTHCARE~100MG~N~020482~002~AB~Sep 6, 1995~No
~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
PREDNISONE~TABLET;ORAL~PREDNICEN-M~SCHWARZ PHARMA~5MG~A~084655~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~SCHWARZ PHARMA INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~BARR~5MG~A~084426~002~~Approved Prior to J
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~BUNDY~5MG~A~083675~001~~Approved Prior to
Jan 1, 1982~No~DISCN~CM BUNDY CO
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~ELKINS SINN~5MG~A~080625~001~~Approved Pri
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~EVERYLIFE~1MG~A~084439~001~~Approved Prior
to Jan 1, 1982~No~DISCN~EVERYLIFE
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~EVERYLIFE~2.5MG~A~084439~002~~Approved Pri
or to Jan 1, 1982~No~DISCN~EVERYLIFE
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~EVERYLIFE~5MG~A~084439~003~~Approved Prior
to Jan 1, 1982~No~DISCN~EVERYLIFE
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~FERRANTE~2.5MG~A~080562~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~FERRANTE~5MG~A~080562~002~~Approved Prior
to Jan 1, 1982~No~DISCN~JOHN J FERRANTE
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~HEATHER~5MG~A~080326~001~~Approved Prior t
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~IMPAX LABS~5MG~A~080780~001~~Approved Prio
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~INWOOD LABS~5MG~A~080748~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~IVAX SUB TEVA PHARMS~5MG~A~080378~001~~App
ICALS USA
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~LANNETT~5MG~A~080531~002~~Approved Prior t
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~MARSHALL PHARMA~5MG~A~080307~001~~Approved
Prior to Jan 1, 1982~No~DISCN~MARSHALL PHARMACAL CORP
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~PANRAY~1MG~A~080351~001~~Approved Prior to
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~PANRAY~5MG~A~080351~002~~Approved Prior to
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~PERRIGO~5MG~A~084542~001~~Approved Prior t
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~PHOENIX LABS NY~5MG~A~080322~001~~Approved

Prior to Jan 1, 1982~No~DISCN~PHOENIX LABORATORIES INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~PUREPAC PHARM~5MG~A~080325~001~~Approved P
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~PVT FORM~5MG~A~080211~001~~Approved Prior
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~ROXANE~5MG~A~080327~002~~Approved Prior to
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~SANDOZ~5MG~A~080339~001~~Approved Prior to
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~SANDOZ~5MG~A~084773~001~~Approved Prior to
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~SPERTI~1MG~A~080358~001~~Approved Prior to
Jan 1, 1982~No~DISCN~SPERTI DRUG PRODUCTS INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~SPERTI~2.5MG~A~080358~002~~Approved Prior
to Jan 1, 1982~No~DISCN~SPERTI DRUG PRODUCTS INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~SPERTI~5MG~A~080358~003~~Approved Prior to
Jan 1, 1982~No~DISCN~SPERTI DRUG PRODUCTS INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~SUPERPHARM~5MG~A~088892~001~~Feb 26, 1985~
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~TABLICAPS~5MG~A~085170~001~~Approved Prior
to Jan 1, 1982~No~DISCN~TABLICAPS INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~TEVA~5MG~A~080398~001~~Approved Prior to J
an 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~UDL~5MG~A~087987~001~~Jan 18, 1983~No~DISC
N~UDL LABORATORIES INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~VALEANT PHARM INTL~5MG~A~080236~001~~Appro
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~VITARINE~5MG~A~080534~001~~Approved Prior
to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~WATSON LABS~5MG~A~080354~001~~Approved Pri
or to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~WEST WARD~5MG~A~080324~001~~Approved Prior
PREDNISOLONE~TABLET;ORAL~PREDNISOLONE~WHITEWORTH TOWN PLSN~5MG~A~080342~001~~App
PREDNISONE~TABLET;ORAL~PREDNISONE~AM THERAP~5MG~A~089387~001~~Nov 6, 1986~No~DIS
CN~AMERICAN THERAPEUTICS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~AM THERAP~10MG~A~089388~001~~Nov 6, 1986~No~DI
SCN~AMERICAN THERAPEUTICS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~AM THERAP~20MG~A~089389~001~~Nov 6, 1986~No~DI
SCN~AMERICAN THERAPEUTICS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~AMNEAL PHARMS NY~5MG~A~089597~001~~Oct 5, 1987
~No~DISCN~AMNEAL PHARMACEUTICALS NY LLC
7~No~DISCN~AMNEAL PHARMACEUTICALS NY LLC
7~No~DISCN~AMNEAL PHARMACEUTICALS NY LLC
PREDNISONE~TABLET;ORAL~PREDNISONE~BUNDY~5MG~A~083676~001~~Approved Prior to Jan
1, 1982~No~DISCN~CM BUNDY CO
PREDNISONE~TABLET;ORAL~PREDNISONE~CONTRACT PHARMACAL~5MG~A~080209~001~AB~Approve
d Prior to Jan 1, 1982~No~RX~CONTRACT PHARMACAL CORP
PREDNISONE~TABLET;ORAL~PREDNISONE~DURAMED PHARMS BARR~5MG~A~088394~001~~Oct 4, 1
PREDNISONE~TABLET;ORAL~PREDNISONE~DURAMED PHARMS BARR~10MG~A~088395~001~~Oct 4,

PREDNISONE~TABLET;ORAL~PREDNISONE~DURAMED PHARMS BARR~20MG~A~088396~001~~Oct 4,
PREDNISONE~TABLET;ORAL~PREDNISONE~ELKINS SINN~5MG~A~080491~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
PREDNISONE~TABLET;ORAL~PREDNISONE~ELKINS SINN~20MG~A~085811~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
PREDNISONE~TABLET;ORAL~PREDNISONE~EVERYLIFE~1MG~A~084440~001~~Approved Prior to
PREDNISONE~TABLET;ORAL~PREDNISONE~EVERYLIFE~2.5MG~A~084440~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~EVERYLIFE
PREDNISONE~TABLET;ORAL~PREDNISONE~EVERYLIFE~5MG~A~084440~003~~Approved Prior to
PREDNISONE~TABLET;ORAL~PREDNISONE~FERRANTE~2.5MG~A~080563~001~~Approved Prior to
Jan 1, 1982~No~DISCN~JOHN J FERRANTE
PREDNISONE~TABLET;ORAL~PREDNISONE~FERRANTE~5MG~A~080563~002~~Approved Prior to J
an 1, 1982~No~DISCN~JOHN J FERRANTE
PREDNISONE~TABLET;ORAL~PREDNISONE~HALSEY~5MG~A~080300~001~~Approved Prior to Jan
PREDNISONE~TABLET;ORAL~PREDNISONE~HEATHER~5MG~A~080320~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~HEATHER DRUG CO INC
PREDNISONE~TABLET;ORAL~PREDNISONE~HEATHER~10MG~A~084341~001~~Approved Prior to J
an 1, 1982~No~DISCN~HEATHER DRUG CO INC
PREDNISONE~TABLET;ORAL~PREDNISONE~HIKMA PHARMS~1MG~A~040890~001~AB~Nov 1, 2010~N
o~RX~HIKMA PHARMACEUTICALS LLC
PREDNISONE~TABLET;ORAL~PREDNISONE~HIKMA PHARMS~2.5MG~A~040538~001~AB~Jan 8, 2004
~No~RX~HIKMA PHARMACEUTICALS LLC
PREDNISONE~TABLET;ORAL~PREDNISONE~HIKMA PHARMS~5MG~A~080292~001~AB~Approved Prio
r to Jan 1, 1982~No~RX~HIKMA PHARMACEUTICALS LLC
PREDNISONE~TABLET;ORAL~PREDNISONE~HIKMA PHARMS~10MG~A~088832~001~AB~Dec 4, 1985~
No~RX~HIKMA PHARMACEUTICALS LLC
PREDNISONE~TABLET;ORAL~PREDNISONE~HIKMA PHARMS~20MG~A~083677~001~AB~Approved Pri
or to Jan 1, 1982~No~RX~HIKMA PHARMACEUTICALS LLC
PREDNISONE~TABLET;ORAL~PREDNISONE~HIKMA PHARMS~50MG~A~088465~001~AB~Jun 1, 1984~
No~RX~HIKMA PHARMACEUTICALS LLC
PREDNISONE~TABLET;ORAL~PREDNISONE~IMPAX LABS~5MG~A~080782~001~~Approved Prior to
PREDNISONE~TABLET;ORAL~PREDNISONE~INWOOD LABS~1MG~A~080328~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~INWOOD LABS~2.5MG~A~080306~001~~Approved Prior
to Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~INWOOD LABS~5MG~A~080279~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~IVAX SUB TEVA PHARMS~5MG~A~080283~001~~Approve
S USA
PREDNISONE~TABLET;ORAL~PREDNISONE~IVAX SUB TEVA PHARMS~10MG~A~084133~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICA
LS USA
PREDNISONE~TABLET;ORAL~PREDNISONE~IVAX SUB TEVA PHARMS~20MG~A~084134~001~~Approv
LS USA
PREDNISONE~TABLET;ORAL~PREDNISONE~JUBILANT CADISTA~1MG~A~040611~001~AB~Jun 6, 20
05~No~RX~JUBILANT CADISTA PHARMACEUTICALS INC

PREDNISONE~TABLET;ORAL~PREDNISONE~JUBILANT CADISTA~5MG~A~040362~002~AB~Aug 29, 2
PREDNISONE~TABLET;ORAL~PREDNISONE~JUBILANT CADISTA~10MG~A~040362~001~AB~Aug 29,
PREDNISONE~TABLET;ORAL~PREDNISONE~JUBILANT CADISTA~20MG~A~040362~003~AB~Jun 29,
PREDNISONE~TABLET;ORAL~PREDNISONE~KV PHARM~5MG~A~084236~001~~Approved Prior to J
an 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
PREDNISONE~TABLET;ORAL~PREDNISONE~LANNETT~5MG~A~080514~001~~Approved Prior to Ja
PREDNISONE~TABLET;ORAL~PREDNISONE~LANNETT~20MG~A~084275~001~~Approved Prior to J
an 1, 1982~No~DISCN~LANNETT CO INC
PREDNISONE~TABLET;ORAL~PREDNISONE~LEDERLE~5MG~A~086968~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
PREDNISONE~TABLET;ORAL~PREDNISONE~MARSHALL PHARMA~5MG~A~080301~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~MARSHALL PHARMACAL CORP
PREDNISONE~TABLET;ORAL~PREDNISONE~MUTUAL PHARM~5MG~A~080701~001~~Approved Prior
PREDNISONE~TABLET;ORAL~PREDNISONE~MUTUAL PHARM~5MG~A~089245~001~AB~Dec 4, 1985~N
PREDNISONE~TABLET;ORAL~PREDNISONE~MUTUAL PHARM~10MG~A~089246~001~AB~Dec 4, 1985~
PREDNISONE~TABLET;ORAL~PREDNISONE~MUTUAL PHARM~20MG~A~089247~001~AB~Dec 4, 1985~
PREDNISONE~TABLET;ORAL~PREDNISONE~NYLOS~5MG~A~085115~001~~Approved Prior to Jan
1, 1982~No~DISCN~NYLOS TRADING CO INC
PREDNISONE~TABLET;ORAL~PREDNISONE~PANRAY~1MG~A~080350~001~~Approved Prior to Jan
PREDNISONE~TABLET;ORAL~PREDNISONE~PANRAY~2.5MG~A~080350~002~~Approved Prior to J
an 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
PREDNISONE~TABLET;ORAL~PREDNISONE~PANRAY~5MG~A~080350~003~~Approved Prior to Jan
PREDNISONE~TABLET;ORAL~PREDNISONE~PERRIGO~5MG~A~083059~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~L PERRIGO CO
PREDNISONE~TABLET;ORAL~PREDNISONE~PHARMAVITE~5MG~A~084662~002~~Approved Prior to
Jan 1, 1982~No~DISCN~PHARMAVITE PHARMACEUTICALS
PREDNISONE~TABLET;ORAL~PREDNISONE~PHOENIX LABS NY~5MG~A~080321~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~PHOENIX LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~PHOENIX LABS NY~20MG~A~083807~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~PHOENIX LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~PUREPAC PHARM~5MG~A~080353~001~~Approved Prior
PREDNISONE~TABLET;ORAL~PREDNISONE~PUREPAC PHARM~10MG~A~086062~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
PREDNISONE~TABLET;ORAL~PREDNISONE~PUREPAC PHARM~20MG~A~086061~001~~Approved Prio
PREDNISONE~TABLET;ORAL~PREDNISONE~PVT FORM~20MG~A~085151~001~~Approved Prior to
Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~REXALL~5MG~A~080232~001~~Approved Prior to Jan
1, 1982~No~DISCN~REXALL DRUG CO
PREDNISONE~TABLET;ORAL~PREDNISONE~ROXANE~1MG~A~087800~001~AB~Apr 22, 1982~Yes~RX
PREDNISONE~TABLET;ORAL~PREDNISONE~ROXANE~2.5MG~A~087801~001~AB~Apr 22, 1982~Yes~
RX~ROXANE LABORATORIES INC

PREDNISONE~TABLET;ORAL~PREDNISONE~ROXANE~5MG~A~080352~001~AB~Approved Prior to J
an 1, 1982~Yes~RX~ROXANE LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~ROXANE~10MG~A~084122~001~AB~Approved Prior to
Jan 1, 1982~Yes~RX~ROXANE LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~ROXANE~20MG~N~017109~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~ROXANE LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~ROXANE~25MG~A~087833~001~~May 4, 1982~No~DISCN
PREDNISONE~TABLET;ORAL~PREDNISONE~SANDOZ~5MG~A~080336~002~~Approved Prior to Jan
PREDNISONE~TABLET;ORAL~PREDNISONE~SANDOZ~5MG~A~084774~001~~Approved Prior to Jan
PREDNISONE~TABLET;ORAL~PREDNISONE~SANDOZ~10MG~A~089983~001~~Jan 12, 1989~No~DISC
N~SANDOZ INC
PREDNISONE~TABLET;ORAL~PREDNISONE~SANDOZ~20MG~A~085813~001~~Approved Prior to Ja
PREDNISONE~TABLET;ORAL~PREDNISONE~SANDOZ~50MG~A~089984~001~~Jan 12, 1989~No~DISC
N~SANDOZ INC
PREDNISONE~TABLET;ORAL~PREDNISONE~SCHERER LABS~5MG~A~080371~001~~Approved Prior
to Jan 1, 1982~No~DISCN~SCHERER LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~SPERTI~1MG~A~080359~001~~Approved Prior to Jan
1, 1982~No~DISCN~SPERTI DRUG PRODUCTS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~SPERTI~2.5MG~A~080359~002~~Approved Prior to J
an 1, 1982~No~DISCN~SPERTI DRUG PRODUCTS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~SPERTI~5MG~A~080359~003~~Approved Prior to Jan
1, 1982~No~DISCN~SPERTI DRUG PRODUCTS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~SUPERPHARM~5MG~A~088865~001~~Oct 25, 1984~No~D
ISCN~SUPERPHARM CORP
PREDNISONE~TABLET;ORAL~PREDNISONE~SUPERPHARM~10MG~A~088866~001~~Oct 25, 1984~No~
PREDNISONE~TABLET;ORAL~PREDNISONE~SUPERPHARM~20MG~A~088867~001~~Oct 25, 1984~No~
PREDNISONE~TABLET;ORAL~PREDNISONE~TEVA~5MG~A~080397~001~~Approved Prior to Jan 1
, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
PREDNISONE~TABLET;ORAL~PREDNISONE~UDL~5MG~A~087984~001~~Jan 18, 1983~No~DISCN~UD
L LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~UDL~10MG~A~087985~001~~Jan 18, 1983~No~DISCN~U
DL LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~UDL~20MG~A~087986~001~~Jan 18, 1983~No~DISCN~U
DL LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~UPSHER SMITH~5MG~A~087471~001~~Approved Prior
to Jan 1, 1982~No~DISCN~UPSHER SMITH LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~UPSHER SMITH~20MG~A~087470~001~~Approved Prior
to Jan 1, 1982~No~DISCN~UPSHER SMITH LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~VALEANT PHARM INTL~5MG~A~080237~001~~Approved
PREDNISONE~TABLET;ORAL~PREDNISONE~VANGARD~5MG~A~087682~001~~Jan 15, 1982~No~DISC
N~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
PREDNISONE~TABLET;ORAL~PREDNISONE~VANGARD~20MG~A~087701~001~~Jan 15, 1982~No~DIS
CN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
PREDNISONE~TABLET;ORAL~PREDNISONE~VINTAGE PHARMS~1MG~A~040584~001~AB~Dec 21, 200
PREDNISONE~TABLET;ORAL~PREDNISONE~VINTAGE PHARMS~2.5MG~A~040581~001~AB~Dec 21, 2
PREDNISONE~TABLET;ORAL~PREDNISONE~VINTAGE PHARMS~5MG~A~040256~001~AB~Jul 12, 200

PREDNISONE~TABLET;ORAL~PREDNISONE~VINTAGE PHARMS~10MG~A~040256~002~AB~Jul 12, 20
PREDNISONE~TABLET;ORAL~PREDNISONE~VINTAGE PHARMS~20MG~A~040392~001~AB~Feb 12, 20
PREDNISONE~TABLET;ORAL~PREDNISONE~VITARINE~5MG~A~080334~001~~Approved Prior to J
an 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~VITARINE~5MG~A~080506~001~~Approved Prior to J
an 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
PREDNISONE~TABLET;ORAL~PREDNISONE~WATSON LABS~5MG~A~080356~001~AB~Approved Prior
to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~WATSON LABS~5MG~A~085084~002~~Approved Prior t
PREDNISONE~TABLET;ORAL~PREDNISONE~WATSON LABS~10MG~A~085162~001~AB~Approved Prio
r to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~WATSON LABS~10MG~A~087773~001~~Jul 13, 1982~No
PREDNISONE~TABLET;ORAL~PREDNISONE~WATSON LABS~20MG~A~085161~001~AB~Approved Prio
r to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
PREDNISONE~TABLET;ORAL~PREDNISONE~WATSON LABS~20MG~A~086813~001~~Approved Prior
PREDNISONE~TABLET;ORAL~PREDNISONE~WATSON LABS~50MG~A~086867~001~~Approved Prior
PREDNISONE~TABLET;ORAL~PREDNISONE~WATSON LABS~50MG~A~087772~001~~Jul 13, 1982~No
PREDNISONE~TABLET;ORAL~PREDNISONE~WHITEWORTH TOWN PLSN~2.5MG~A~084913~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
PREDNISONE~TABLET;ORAL~PREDNISONE~WHITEWORTH TOWN PLSN~5MG~A~080343~001~~Approve
PREDNISONE~TABLET;ORAL~PREDNISONE~WHITEWORTH TOWN PLSN~10MG~A~089028~001~~Jul 24
, 1986~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
PREDNISONE~TABLET;ORAL~PREDNISONE~WHITEWORTH TOWN PLSN~20MG~A~084913~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
ESTRADIOL; NORGESTIMATE~TABLET;ORAL~PREFEST~TEVA WOMENS~1MG,1MG;N/A,0.09MG **Fed
afety or efficacy reasons**~N~021040~001~~Oct 22, 1999~No~DISCN~TEVA WOMENS HEAL
TH INC
TROGLITAZONE~TABLET;ORAL~PRELAY~SANKYO~200MG~N~020719~001~~Jan 29, 1997~No~DISCN
~SANKYO USA CORP
TROGLITAZONE~TABLET;ORAL~PRELAY~SANKYO~300MG~N~020719~003~~Aug 4, 1997~No~DISCN~
SANKYO USA CORP
TROGLITAZONE~TABLET;ORAL~PRELAY~SANKYO~400MG~N~020719~002~~Jan 29, 1997~No~DISCN
~SANKYO USA CORP
PHENMETRAZINE HYDROCHLORIDE~TABLET;ORAL~PRELUDIN~BOEHRINGER INGELHEIM~25MG~N~010
460~005~~Approved Prior to Jan 1, 1982~No~DISCN~BOEHRINGER INGELHEIM PHARMACEUTI
CALS INC
ESTROGENS, CONJUGATED~TABLET;ORAL~PREMARIN~WYETH PHARMS INC~0.3MG~N~004782~003~~
Approved Prior to Jan 1, 1982~No~RX~WYETH PHARMACEUTICALS INC
ESTROGENS, CONJUGATED~TABLET;ORAL~PREMARIN~WYETH PHARMS INC~0.45MG~N~004782~006~
~Jul 16, 2003~No~RX~WYETH PHARMACEUTICALS INC
ESTROGENS, CONJUGATED~TABLET;ORAL~PREMARIN~WYETH PHARMS INC~0.625MG~N~004782~004
~~Approved Prior to Jan 1, 1982~Yes~RX~WYETH PHARMACEUTICALS INC
Jan 26, 1984~Yes~RX~WYETH PHARMACEUTICALS INC
ESTROGENS, CONJUGATED~TABLET;ORAL~PREMARIN~WYETH PHARMS INC~1.25MG~N~004782~001~
~Approved Prior to Jan 1, 1982~Yes~RX~WYETH PHARMACEUTICALS INC
Approved Prior to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICALS INC
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~PRESAMINE~SANOFI AVENTIS US~10MG~N~011836~0

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE~TABLET;ORAL~PRESTALIA~SYMPLMED PHARMS
LLC~EQ 2.5MG BASE;3.5MG ~N~205003~001~~Jan 21, 2015~No~RX~SYMPLMED PHARMACEUTICA
LS LLC
LLC~EQ 5MG BASE;7MG~N~205003~002~~Jan 21, 2015~No~RX~SYMPLMED PHARMACEUTICALS LL
C
LLC~EQ 10MG BASE;14MG~N~205003~003~~Jan 21, 2015~Yes~RX~SYMPLMED PHARMACEUTICALS
LLC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~PREVEN EMERGENCY CONTRACEPTIVE KIT
~TEVA BRANDED PHARM~0.05MG;0.25MG~N~020946~001~~Sep 1, 1998~No~DISCN~TEVA BRANDE
D PHARMACEUTICAL PRODUCTS R AND D INC
COBICISTAT; DARUNAVIR ETHANOLATE~TABLET;ORAL~PREZCOBIX~JANSSEN PRODS~150MG;EQ 80
0MG BASE~N~205395~001~~Jan 29, 2015~Yes~RX~JANSSEN PRODUCTS LP
DARUNAVIR ETHANOLATE~TABLET;ORAL~PREZISTA~JANSSEN PRODS~EQ 75MG BASE~N~021976~00
4~~Dec 18, 2008~No~RX~JANSSEN PRODUCTS LP
05~~Dec 18, 2008~No~RX~JANSSEN PRODUCTS LP
DARUNAVIR ETHANOLATE~TABLET;ORAL~PREZISTA~JANSSEN PRODS~EQ 300MG BASE **Federal
or efficacy reasons**~N~021976~001~~Jun 23, 2006~No~DISCN~JANSSEN PRODUCTS LP
DARUNAVIR ETHANOLATE~TABLET;ORAL~PREZISTA~JANSSEN PRODS~EQ 400MG BASE **Federal
or efficacy reasons**~N~021976~003~~Oct 21, 2008~No~DISCN~JANSSEN PRODUCTS LP
02~~Feb 25, 2008~No~RX~JANSSEN PRODUCTS LP
06~~Nov 9, 2012~Yes~RX~JANSSEN PRODUCTS LP
RIFAPENTINE~TABLET;ORAL~PRIFTIN~SANOFI AVENTIS US~150MG~N~021024~001~~Jun 22, 19
PRIMAQUINE PHOSPHATE~TABLET;ORAL~PRIMAQUINE~SANOFI AVENTIS US~EQ 15MG BASE~N~008
316~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~SANOFI AVENTIS US LLC
PRIMAQUINE PHOSPHATE~TABLET;ORAL~PRIMAQUINE PHOSPHATE~ALVOGEN INC~EQ 15MG BASE~A
~203924~001~AB~Feb 3, 2014~No~RX~ALVOGEN INC
PRIMAQUINE PHOSPHATE~TABLET;ORAL~PRIMAQUINE PHOSPHATE~BAYSHORE PHARMS LLC~EQ 15M
G BASE~A~204476~001~AB~Feb 25, 2014~No~RX~BAYSHORE PHARMACEUTICALS LLC
PRIMIDONE~TABLET;ORAL~PRIMIDONE~AMNEAL PHARM~50MG~A~040866~001~AB~Apr 23, 2008~N
o~RX~AMNEAL PHARMACEUTICAL
PRIMIDONE~TABLET;ORAL~PRIMIDONE~AMNEAL PHARM~250MG~A~040866~002~AB~Apr 23, 2008~
No~RX~AMNEAL PHARMACEUTICAL
PRIMIDONE~TABLET;ORAL~PRIMIDONE~DR REDDYS LABS LTD~50MG~A~040862~001~~Oct 3, 200
PRIMIDONE~TABLET;ORAL~PRIMIDONE~DR REDDYS LABS LTD~250MG~A~040862~002~~Oct 3, 20
PRIMIDONE~TABLET;ORAL~PRIMIDONE~HIKMA PHARMS LLC~50MG~A~040667~001~~Jul 27, 2006
~No~DISCN~HIKMA PHARMACEUTICALS LLC
PRIMIDONE~TABLET;ORAL~PRIMIDONE~HIKMA PHARMS LLC~250MG~A~040667~002~AB~Jul 27, 2
PRIMIDONE~TABLET;ORAL~PRIMIDONE~IMPAX LABS~50MG~A~040717~001~AB~Feb 12, 2008~No~
RX~IMPAX LABORATORIES INC
PRIMIDONE~TABLET;ORAL~PRIMIDONE~IMPAX LABS~250MG~A~040717~002~AB~Feb 12, 2008~No
~RX~IMPAX LABORATORIES INC
PRIMIDONE~TABLET;ORAL~PRIMIDONE~LANNETT~50MG~A~084903~002~AB~May 24, 2001~No~RX~
LANNETT CO INC
PRIMIDONE~TABLET;ORAL~PRIMIDONE~LANNETT~250MG~A~084903~001~AB~Approved Prior to
Jan 1, 1982~No~RX~LANNETT CO INC
PRIMIDONE~TABLET;ORAL~PRIMIDONE~MUTUAL PHARM~50MG~A~040626~001~AB~Sep 29, 2005~N

PRIMIDONE~TABLET;ORAL~PRIMIDONE~MUTUAL PHARM~250MG~A~040626~002~AB~Sep 29, 2005~
PRIMIDONE~TABLET;ORAL~PRIMIDONE~VINTAGE PHARMS~50MG~A~040586~001~AB~Feb 24, 2005
PRIMIDONE~TABLET;ORAL~PRIMIDONE~VINTAGE PHARMS~250MG~A~040586~002~AB~Feb 24, 200
PRIMIDONE~TABLET;ORAL~PRIMIDONE~WATSON LABS~250MG~A~083551~001~AB~Approved Prior
to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
PRIMIDONE~TABLET;ORAL~PRIMIDONE~WATSON LABS~250MG~A~085052~001~~Approved Prior t
LISINOPRIL~TABLET;ORAL~PRINIVIL~MERCK~2.5MG~N~019558~006~~Jan 28, 1994~No~DISCN~
MERCK RESEARCH LABORATORIES DIV MERCK CO INC
LISINOPRIL~TABLET;ORAL~PRINIVIL~MERCK~5MG~N~019558~001~AB~Dec 29, 1987~No~RX~MER
CK RESEARCH LABORATORIES DIV MERCK CO INC
LISINOPRIL~TABLET;ORAL~PRINIVIL~MERCK~10MG~N~019558~002~AB~Dec 29, 1987~No~RX~ME
LISINOPRIL~TABLET;ORAL~PRINIVIL~MERCK~20MG~N~019558~003~AB~Dec 29, 1987~No~RX~ME
LISINOPRIL~TABLET;ORAL~PRINIVIL~MERCK~40MG~N~019558~004~AB~Oct 25, 1988~No~RX~ME
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~PRINZIDE~MERCK~12.5MG;10MG~N~019778~
003~AB~Nov 18, 1993~No~RX~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~PRINZIDE~MERCK~12.5MG;20MG~N~019778~
001~AB~Feb 16, 1989~No~RX~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~PRINZIDE~MERCK~25MG;20MG~N~019778~00
2~~Feb 16, 1989~No~DISCN~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PRO-BANTHINE~SHIRE~7.5MG **Federal Register de
y reasons**~N~008732~003~~Approved Prior to Jan 1, 1982~No~DISCN~SHIRE DEVELOPME
NT INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PRO-BANTHINE~SHIRE~15MG~N~008732~002~~Approved
Prior to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~PROAMATINE~SHIRE LLC~2.5MG~N~019815~001~~Sep
6, 1996~No~DISCN~SHIRE DEVELOPMENT LLC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~PROAMATINE~SHIRE LLC~5MG~N~019815~002~~Sep 6
, 1996~No~DISCN~SHIRE DEVELOPMENT LLC
MIDODRINE HYDROCHLORIDE~TABLET;ORAL~PROAMATINE~SHIRE LLC~10MG~N~019815~003~~Mar
20, 2002~No~DISCN~SHIRE DEVELOPMENT LLC
PROBENECID~TABLET;ORAL~PROBALAN~LANNETT~500MG~A~080966~001~AB~Approved Prior to
Jan 1, 1982~No~RX~LANNETT CO INC
COLCHICINE; PROBENECID~TABLET;ORAL~PROBEN-C~WATSON LABS~0.5MG;500MG~A~085552~001
~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
PROBENECID~TABLET;ORAL~PROBENECID~IVAX SUB TEVA PHARMS~500MG~A~083740~001~~May 9
PROBENECID~TABLET;ORAL~PROBENECID~LEDERLE~500MG~A~086917~001~~Approved Prior to
PROBENECID~TABLET;ORAL~PROBENECID~MYLAN~500MG~A~084211~002~AB~Approved Prior to
Jan 1, 1982~Yes~RX~MYLAN PHARMACEUTICALS INC
PROBENECID~TABLET;ORAL~PROBENECID~WATSON LABS~500MG~A~084442~004~AB~Mar 29, 1983
PROBENECID~TABLET;ORAL~PROBENECID~WATSON LABS~500MG~A~086150~002~~Apr 23, 1982~N
COLCHICINE; PROBENECID~TABLET;ORAL~PROBENECID AND COLCHICINE~BEECHAM~0.5MG;500MG
~A~084321~001~~Approved Prior to Jan 1, 1982~No~DISCN~BEECHAM LABORATORIES DIV B
EECHAM INC
COLCHICINE; PROBENECID~TABLET;ORAL~PROBENECID AND COLCHICINE~IMPAX LABS~0.5MG;50
0MG~A~083720~002~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
COLCHICINE; PROBENECID~TABLET;ORAL~PROBENECID AND COLCHICINE~IVAX SUB TEVA PHARM
S~0.5MG;500MG~A~083734~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACE

COLCHICINE; PROBENECID~TABLET;ORAL~PROBENECID AND COLCHICINE~MIRROR PHARMS~0.5MG
;500MG~A~040618~001~AB~May 13, 2008~No~RX~MIRROR PHARMACEUTICALS LLC
COLCHICINE; PROBENECID~TABLET;ORAL~PROBENECID AND COLCHICINE~SANDOZ~0.5MG;500MG~
COLCHICINE; PROBENECID~TABLET;ORAL~PROBENECID W/ COLCHICINE~LEDERLE~0.5MG;500MG~
A~086954~001~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AM
ERICAN CYANAMID CO
COLCHICINE; PROBENECID~TABLET;ORAL~PROBENECID W/ COLCHICINE~WATSON LABS~0.5MG;50
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE~WATSON LABS~EQ 5MG BASE~A~
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE~WATSON LABS~EQ 10MG BASE~A
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE~WATSON LABS~EQ 25MG BASE~A
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~DURAMED PHARMS BAR
R~EQ 5MG BASE~A~040207~001~~May 1, 1997~No~DISCN~DURAMED PHARMACEUTICALS INC SUB
R~EQ 5MG BASE~A~089484~001~~Jan 20, 1987~No~DISCN~DURAMED PHARMACEUTICALS INC SU
R~EQ 10MG BASE~A~040207~002~~May 1, 1997~No~DISCN~DURAMED PHARMACEUTICALS INC SU
R~EQ 10MG BASE~A~089485~001~~Jan 20, 1987~No~DISCN~DURAMED PHARMACEUTICALS INC S
R~EQ 25MG BASE~A~089486~001~~Jan 20, 1987~No~DISCN~DURAMED PHARMACEUTICALS INC S
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~IVAX SUB TEVA PHAR
MS~EQ 5MG BASE~A~040162~001~~Jan 20, 1998~No~DISCN~IVAX PHARMACEUTICALS INC SUB
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~IVAX SUB TEVA PHAR
MS~EQ 10MG BASE~A~040162~002~~Jan 20, 1998~No~DISCN~IVAX PHARMACEUTICALS INC SUB
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~MYLAN~EQ 5MG BASE~
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~MYLAN~EQ 10MG BASE
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~SANDOZ~EQ 5MG BASE
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~SANDOZ~EQ 10MG BAS
E~A~040101~002~AB~Jul 19, 1996~Yes~RX~SANDOZ INC
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~SANDOZ~EQ 25MG BAS
E~A~040101~003~~Jul 19, 1996~No~DISCN~SANDOZ INC
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~TEVA PHARMS~EQ 5MG
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCHLORPERAZINE MALEATE~TEVA PHARMS~EQ 10M
G BASE~A~040120~002~AB~Jul 11, 1996~No~RX~TEVA PHARMACEUTICALS USA
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCOMP~JUBILANT CADISTA~EQ 5MG BASE~A~0402
PROCHLORPERAZINE MALEATE~TABLET;ORAL~PROCOMP~JUBILANT CADISTA~EQ 10MG BASE~A~040
IBUPROFEN~TABLET;ORAL~PROFEN~CONTRACT PHARMACAL~200MG~A~071265~001~~Oct 15, 1986
~No~OTC~CONTRACT PHARMACAL CORP
CARPHENAZINE MALEATE~TABLET;ORAL~PROKETAZINE~WYETH AYERST~12.5MG~N~012768~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
CARPHENAZINE MALEATE~TABLET;ORAL~PROKETAZINE~WYETH AYERST~25MG~N~012768~002~~App

CARPHENAZINE MALEATE~TABLET;ORAL~PROKETAZINE~WYETH AYERST~50MG~N~012768~004~~App
SULFAMETHIZOLE~TABLET;ORAL~PROKLAR~FOREST PHARMS~500MG~A~080273~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~FOREST PHARMACEUTICALS INC
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~PROLIXIN~APOTHECON~1MG~N~011751~004~~Appr
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~PROLIXIN~APOTHECON~2.5MG~N~011751~001~~Ap
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~PROLIXIN~APOTHECON~5MG~N~011751~003~~Appr
FLUPHENAZINE HYDROCHLORIDE~TABLET;ORAL~PROLIXIN~APOTHECON~10MG~N~011751~002~~App
THYROGLOBULIN~TABLET;ORAL~PROLOID~PARKE DAVIS~16MG~N~002245~009~~Approved Prior
TRIMETHOPRIM~TABLET;ORAL~PROLOPRIM~MONARCH PHARMS~100MG~N~017943~001~~Approved P
rior to Jan 1, 1982~No~DISCN~MONARCH PHARMACEUTICALS INC
TRIMETHOPRIM~TABLET;ORAL~PROLOPRIM~MONARCH PHARMS~200MG~N~017943~003~~Jul 14, 19
82~No~DISCN~MONARCH PHARMACEUTICALS INC
ELTROMBOPAG OLAMINE~TABLET;ORAL~PROMACTA~GLAXOSMITHKLINE~EQ 12.5MG ACID~N~022291
~004~~Oct 20, 2011~No~RX~GLAXOSMITHKLINE
ELTROMBOPAG OLAMINE~TABLET;ORAL~PROMACTA~GLAXOSMITHKLINE~EQ 25MG ACID~N~022291~0
01~~Nov 20, 2008~No~RX~GLAXOSMITHKLINE
02~~Nov 20, 2008~Yes~RX~GLAXOSMITHKLINE
03~~Sep 8, 2009~No~RX~GLAXOSMITHKLINE
ELTROMBOPAG OLAMINE~TABLET;ORAL~PROMACTA~GLAXOSMITHKLINE~EQ 100MG ACID~N~022291~
005~~Nov 16, 2012~No~RX~GLAXOSMITHKLINE
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~PROMAPAR~PARKE DAVIS~10MG~A~086886~001~
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~PROMAPAR~PARKE DAVIS~100MG~A~086888~001
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~PROMAPAR~PARKE DAVIS~200MG~A~086885~001
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~ABBOTT~12.5MG~
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~ABBOTT~25MG~A~
TICAL PRODUCTS DIV
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~ABBOTT~50MG~A~
TICAL PRODUCTS DIV

PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~ABLE~12.5MG~A~
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~ABLE~25MG~A~04
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~ABLE~50MG~A~04
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~AMNEAL PHARMS
NY~12.5MG~A~091179~001~AB~Dec 13, 2010~No~RX~AMNEAL PHARMACEUTICALS NY LLC
NY~25MG~A~091179~002~AB~Dec 13, 2010~No~RX~AMNEAL PHARMACEUTICALS NY LLC
NY~50MG~A~091179~003~AB~Dec 13, 2010~No~RX~AMNEAL PHARMACEUTICALS NY LLC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~EMCURE PHARMS
USA~12.5MG~A~040673~001~AB~Mar 5, 2008~No~RX~EMCURE PHARMACEUTICALS USA INC
USA~25MG~A~040673~002~AB~Mar 5, 2008~No~RX~EMCURE PHARMACEUTICALS USA INC
USA~50MG~A~040673~003~AB~Mar 5, 2008~No~RX~EMCURE PHARMACEUTICALS USA INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~IMPAX LABS~12.
5MG~A~040724~001~AB~Feb 12, 2008~No~RX~IMPAX LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~IMPAX LABS~25M
G~A~040724~002~AB~Feb 12, 2008~No~RX~IMPAX LABORATORIES INC
G~A~084214~002~~Jul 7, 1982~No~DISCN~IMPAX LABORATORIES INC
G~A~040791~001~AB~May 20, 2008~No~RX~IMPAX LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~IVAX SUB TEVA
PHARMS~12.5MG~A~083604~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACE
PHARMS~25MG~A~083603~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUT
PHARMS~50MG~A~083613~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUT
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~KVK TECH~12.5M
G~A~040712~002~AB~May 4, 2007~No~RX~KVK TECH INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~KVK TECH~25MG~
A~040712~001~AB~Jul 31, 2006~No~RX~KVK TECH INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~KVK TECH~50MG~
A~040713~001~AB~Jul 31, 2006~No~RX~KVK TECH INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~LANNETT~12.5MG
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~LANNETT~25MG~A
~080949~002~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~LANNETT~50MG~A
~080949~003~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~MUTUAL PHARM~1
2.5MG~A~084555~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL
CO INC
5MG~A~084554~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL C
O INC
0MG~A~084557~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL C
O INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~MYLAN~12.5MG~A
~091054~001~AB~Aug 30, 2011~No~RX~MYLAN PHARMACEUTICALS INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~MYLAN~25MG~A~0

PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~MYLAN~50MG~A~0
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~PVT FORM~12.5M
G~A~083214~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~PVT FORM~25MG~
A~083658~001~~Approved Prior to Jan 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~SANDOZ~12.5MG~
A~084176~002~~May 22, 2009~No~DISCN~SANDOZ INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~SANDOZ~12.5MG~
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~SANDOZ~25MG~A~
084176~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~SANDOZ INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~SUN PHARM INDS
INC~12.5MG~A~040863~001~AB~Dec 30, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
INC~25MG~A~040863~002~AB~Dec 30, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
INC~50MG~A~040863~003~AB~Dec 30, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~TABLICAPS~12.5
MG~A~084080~001~~Approved Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~TABLICAPS~25MG
~A~084027~001~~Approved Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~TEVA~25MG~A~08
9109~001~~Sep 10, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~VINTAGE PHARMS
~12.5MG~A~040622~001~AB~Jul 18, 2006~No~RX~VINTAGE PHARMACEUTICALS INC
~25MG~A~040622~002~AB~Jul 18, 2006~No~RX~VINTAGE PHARMACEUTICALS INC
~50MG~A~040622~003~AB~Jul 18, 2006~No~RX~VINTAGE PHARMACEUTICALS INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~WATSON LABS~12
.5MG~A~083401~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES IN
C
C
C
MG~A~083426~001~AB~Approved Prior to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
MG~A~083711~001~AB~Approved Prior to Jan 1, 1982~No~RX~WATSON LABORATORIES INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~PROMETHAZINE HYDROCHLORIDE~ZYDUS PHARMS U
SA~12.5MG~A~040596~001~AB~Nov 18, 2005~No~RX~ZYDUS PHARMACEUTICALS USA INC

SA~25MG~A~040596~002~AB~Nov 18, 2005~No~RX~ZYDUS PHARMACEUTICALS USA INC
SA~50MG~A~040596~003~AB~Nov 18, 2005~No~RX~ZYDUS PHARMACEUTICALS USA INC
PROCAINAMIDE HYDROCHLORIDE~TABLET;ORAL~PRONESTYL~APOTHECON~250MG~N~017371~001~~A
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE~TABLET;ORAL~PROPACET 100~TEVA~650MG;100MG~
A~070107~001~~Jun 12, 1985~No~DISCN~TEVA PHARMACEUTICALS USA INC
PROPAFENONE HYDROCHLORIDE~TABLET;ORAL~PROPAFENONE HYDROCHLORIDE~ANI PHARMS INC~1
50MG~A~076550~001~AB~Apr 23, 2004~No~RX~ANI PHARMACEUTICALS INC
PROPAFENONE HYDROCHLORIDE~TABLET;ORAL~PROPAFENONE HYDROCHLORIDE~MUTUAL PHARM~150
MG~A~075998~001~AB~Nov 29, 2001~No~RX~MUTUAL PHARMACEUTICAL CO INC
PROPAFENONE HYDROCHLORIDE~TABLET;ORAL~PROPAFENONE HYDROCHLORIDE~NESHER PHARMS~15
0MG~A~076193~001~~Feb 7, 2002~No~DISCN~NESHER PHARMACEUTICALS USA LLC
PROPAFENONE HYDROCHLORIDE~TABLET;ORAL~PROPAFENONE HYDROCHLORIDE~VINTAGE PHARMS~1
50MG~A~075938~001~AB~Oct 17, 2002~No~RX~VINTAGE PHARMACEUTICALS INC
PROPAFENONE HYDROCHLORIDE~TABLET;ORAL~PROPAFENONE HYDROCHLORIDE~WATSON LABS~150M
G~A~075203~001~AB~Oct 24, 2000~No~RX~WATSON LABORATORIES
PROPAFENONE HYDROCHLORIDE~TABLET;ORAL~PROPAFENONE HYDROCHLORIDE~WATSON LABS~225M
G~A~075203~002~AB~Oct 24, 2000~No~RX~WATSON LABORATORIES
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~ASCOT~15MG~A~087663~001~
~Oct 25, 1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES
INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~HEATHER~15MG~A~085780~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~IMPAX LABS~15MG~A~084541
~002~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~MYLAN~15MG~A~083706~001~
~Approved Prior to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~PAR PHARM~15MG~A~088377~
001~~Dec 8, 1983~No~DISCN~PAR PHARMACEUTICAL INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~PVT FORM~15MG~A~080977~0
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~ROXANE~7.5MG~A~080927~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~ROXANE~15MG~A~080927~002
~~Approved Prior to Jan 1, 1982~Yes~RX~ROXANE LABORATORIES INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~SANDOZ~15MG~A~080928~001
~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~TABLICAPS~15MG~A~084428~
001~~Approved Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC

PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~WATSON LABS~15MG~A~08302
PROPANTHELINE BROMIDE~TABLET;ORAL~PROPANTHELINE BROMIDE~WATSON LABS~15MG~A~08315
FINASTERIDE~TABLET;ORAL~PROPECIA~MERCK~1MG~N~020788~001~AB~Dec 19, 1997~Yes~RX~M
ERCK RESEARCH LABORATORIES DIV MERCK CO INC
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE~TABLET;ORAL~PROPOXYPHENE HYDROCHLORIDE
AND ACETAMINOPHEN~MYLAN~325MG;32MG~A~083689~001~~Approved Prior to Jan 1, 1982~
No~DISCN~MYLAN PHARMACEUTICALS INC
AND ACETAMINOPHEN~MYLAN~650MG;65MG~A~083978~001~~Approved Prior to Jan 1, 1982~
No~DISCN~MYLAN PHARMACEUTICALS INC
AND ACETAMINOPHEN~SANDOZ~650MG;65MG~A~089959~001~~Jul 18, 1989~No~DISCN~SANDOZ
INC
AND ACETAMINOPHEN~VINTAGE PHARMS~650MG;65MG~A~040507~001~~Jul 30, 2003~No~DISCN
~VINTAGE PHARMACEUTICALS INC
AND ACETAMINOPHEN~WATSON LABS~650MG;65MG~A~040139~001~~Dec 16, 1996~No~DISCN~WA
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE~TABLET;ORAL~PROPOXYPHENE NAPSYLATE AND ACE
TAMINOPHEN~ABLE~650MG;100MG~A~075838~001~~Jul 11, 2001~No~DISCN~ABLE LABORATORIE
S INC
TAMINOPHEN~ACTAVIS ELIZABETH~650MG;100MG~A~070910~001~~Jan 2, 1987~No~DISCN~ACTA
VIS ELIZABETH LLC
TAMINOPHEN~CORNERSTONE~325MG;100MG~A~076743~001~~May 7, 2004~No~DISCN~CORNERSTON
E BIOPHARMA INC
TAMINOPHEN~CORNERSTONE~500MG;100MG~A~076750~001~~Jun 28, 2004~No~DISCN~CORNERSTO
NE BIOPHARMA INC
TAMINOPHEN~HALSEY~325MG;50MG~A~072105~001~~May 13, 1988~No~DISCN~HALSEY DRUG CO
INC
TAMINOPHEN~HALSEY~650MG;100MG~A~072106~001~~May 13, 1988~No~DISCN~HALSEY DRUG CO
INC
TAMINOPHEN~IVAX SUB TEVA PHARMS~650MG;100MG~A~070146~001~~Aug 2, 1985~No~DISCN~I
VAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
TAMINOPHEN~MALLINCKRODT~650MG;100MG~A~075738~001~~Feb 2, 2001~No~DISCN~MALLINCKR
ODT INC
TAMINOPHEN~MIRROR PHARMS~650MG;100MG~A~077821~001~~Feb 11, 2008~No~DISCN~MIRROR
PHARMACEUTICALS LLC
TAMINOPHEN~MUTUAL PHARM~325MG;50MG~A~070115~001~~Jun 12, 1985~No~DISCN~MUTUAL PH
ARMACEUTICAL CO INC
TAMINOPHEN~MUTUAL PHARM~650MG;100MG~A~070116~001~~Jun 12, 1985~No~DISCN~MUTUAL P
TAMINOPHEN~MUTUAL PHARM~650MG;100MG~A~070615~001~~Mar 21, 1986~No~DISCN~MUTUAL P
TAMINOPHEN~MYLAN~650MG;100MG~A~072195~001~~Feb 16, 1988~No~DISCN~MYLAN PHARMACEU
TICALS INC
TAMINOPHEN~MYLAN PHARMS INC~650MG;100MG~A~070145~001~~Jun 12, 1985~No~DISCN~MYLA
TAMINOPHEN~SANDOZ~650MG;100MG~A~070443~001~~Jan 23, 1986~No~DISCN~SANDOZ INC
TAMINOPHEN~SUPERPHARM~650MG;100MG~A~071319~001~~Jan 6, 1987~No~DISCN~SUPERPHARM
CORP
TAMINOPHEN~TEVA~650MG;100MG~A~070732~001~~Jan 3, 1986~No~DISCN~TEVA PHARMACEUTIC
ALS USA INC
TAMINOPHEN~TEVA~650MG;100MG~A~074119~001~~Dec 19, 1994~No~DISCN~TEVA PHARMACEUTI
CALS USA INC
TAMINOPHEN~VINTAGE PHARMS~325MG;50MG~A~074843~002~~Feb 15, 2001~No~DISCN~VINTAGE
PHARMACEUTICALS INC
TAMINOPHEN~VINTAGE PHARMS~650MG;100MG~A~074843~001~~Feb 12, 1997~No~DISCN~VINTAG
TAMINOPHEN~WATSON LABS~325MG;50MG~A~070398~001~~Dec 18, 1986~No~DISCN~WATSON LAB
ORATORIES INC
TAMINOPHEN~WATSON LABS~650MG;100MG~A~070399~001~~Dec 18, 1986~No~DISCN~WATSON LA
BORATORIES INC
TAMINOPHEN~WATSON LABS FLORIDA~500MG;100MG~A~077196~001~~Jun 28, 2005~No~DISCN~W
TAMINOPHEN~WATSON LABS FLORIDA~650MG;100MG~A~076609~001~~Nov 16, 2004~No~DISCN~W
TAMINOPHEN~WOCKHARDT LTD~325MG;50MG~A~077677~001~~Mar 16, 2007~No~DISCN~WOCKHARD
T LTD
TAMINOPHEN~WOCKHARDT LTD~650MG;100MG~A~077677~002~~Mar 16, 2007~No~DISCN~WOCKHAR
DT LTD
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~ANI PHARMS INC~9
0MG~A~071977~001~~Apr 6, 1988~No~DISCN~ANI PHARMACEUTICALS INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~DAVA PHARMS INC~
10MG~A~070125~001~~Jul 30, 1985~No~DISCN~DAVA PHARMACEUTICALS INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~DURAMED PHARMS B
ARR~10MG~A~070306~001~~Sep 9, 1985~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR

LABORATORIES INC
LABORATORIES INC
LABORATORIES INC
ARR~60MG~A~070309~001~~Oct 1, 1986~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR
LABORATORIES INC
LABORATORIES INC
ARR~90MG~A~071327~001~~Oct 1, 1986~No~DISCN~DURAMED PHARMACEUTICALS INC SUB BARR
LABORATORIES INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~INTERPHARM~10MG~
A~071368~001~~May 5, 1987~No~DISCN~INTERPHARM INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~IPCA LABS LTD~10
MG~A~078955~001~AB~Jun 2, 2008~No~RX~IPCA LABORATORIES LTD
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~IVAX SUB TEVA PH
ARMS~10MG~A~072063~001~~Jul 29, 1988~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA
PHARMACEUTICALS USA
PHARMACEUTICALS USA
PHARMACEUTICALS USA
PHARMACEUTICALS USA
PHARMACEUTICALS USA
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~LEDERLE~10MG~A~0
72117~001~~Jun 23, 1988~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~MUTUAL PHARM~10M
G~A~070319~001~~Oct 22, 1985~No~DISCN~MUTUAL PHARMACEUTICAL CO INC

G~A~070321~001~~Sep 24, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
G~A~070322~001~~Aug 4, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~MYLAN~10MG~A~070
213~002~AB~Nov 19, 1985~No~RX~MYLAN PHARMACEUTICALS INC
275~001~~Jun 9, 1989~No~DISCN~MYLAN PHARMACEUTICALS INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~NORTHSTAR HLTHCA
RE~10MG~A~078213~001~AB~Jan 10, 2008~No~RX~NORTHSTAR HEALTHCARE HOLDINGS LTD
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~PAR PHARM~90MG~A
~071288~001~~Oct 22, 1986~No~DISCN~PAR PHARMACEUTICAL INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~PLIVA~10MG~A~071
972~001~AB~Apr 6, 1988~No~RX~PLIVA INC
976~001~AB~Apr 6, 1988~Yes~RX~PLIVA INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~PUREPAC PHARM~10
MG~A~070814~001~~Nov 3, 1986~No~DISCN~PUREPAC PHARMACEUTICAL CO
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~ROXANE~10MG~A~07

PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~SANDOZ~10MG~A~07
0666~001~~Oct 10, 1986~No~DISCN~SANDOZ INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~SCHERING~10MG~A~
070120~001~~Aug 6, 1985~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
070123~001~~Oct 29, 1986~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~SUPERPHARM~10MG~
A~071515~001~~Jun 8, 1988~No~DISCN~SUPERPHARM CORP
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~TEVA~10MG~A~0702
32~001~~Oct 7, 1987~No~DISCN~TEVA PHARMACEUTICALS USA INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~VINTAGE PHARMS~1
0MG~A~070217~001~AB~Aug 1, 1986~No~RX~VINTAGE PHARMACEUTICALS
0MG~A~070220~001~AB~Sep 24, 1986~No~RX~VINTAGE PHARMACEUTICALS
0MG~A~070221~001~AB~Apr 14, 1986~No~RX~VINTAGE PHARMACEUTICALS
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~WARNER CHILCOTT~

10MG~A~070438~001~~Sep 15, 1986~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
20MG~A~070439~001~~Sep 15, 1986~No~DISCN~WARNER CHILCOTT INC
PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLORIDE~WATSON LABS~10MG
~A~070140~001~~Jul 30, 1985~No~DISCN~WATSON LABORATORIES INC
~A~070175~001~AB~May 13, 1986~No~RX~WATSON LABORATORIES INC
~A~070143~001~~Jan 15, 1987~No~DISCN~WATSON LABORATORIES INC
~A~071098~001~~Oct 6, 1986~No~DISCN~WATSON LABORATORIES INC
~A~071183~001~~Oct 6, 1986~No~DISCN~WATSON LABORATORIES INC
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE~TABLET;ORAL~PROPRANOLOL HYDROCHLO
RIDE & HYDROCHLOROTHIAZIDE~DURAMED PHARMS BARR~25MG;40MG~A~071126~001~~Mar 2, 19
RIDE & HYDROCHLOROTHIAZIDE~DURAMED PHARMS BARR~25MG;80MG~A~071127~001~~Mar 2, 19

RIDE AND HYDROCHLOROTHIAZIDE~ACTAVIS ELIZABETH~25MG;40MG~A~070851~001~~May 15, 1
RIDE AND HYDROCHLOROTHIAZIDE~ACTAVIS ELIZABETH~25MG;80MG~A~070852~001~~May 15, 1
RIDE AND HYDROCHLOROTHIAZIDE~BARR~25MG;40MG~A~070704~001~~Oct 1, 1986~No~DISCN~B
RIDE AND HYDROCHLOROTHIAZIDE~BARR~25MG;80MG~A~070705~001~~Oct 1, 1986~No~DISCN~B
RIDE AND HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~25MG;40MG~A~071552~001~~Dec 1,
RIDE AND HYDROCHLOROTHIAZIDE~IVAX SUB TEVA PHARMS~25MG;80MG~A~071553~001~~Dec 1,
RIDE AND HYDROCHLOROTHIAZIDE~MYLAN~25MG;40MG~A~070947~002~AB~Mar 4, 1987~No~RX~M
RIDE AND HYDROCHLOROTHIAZIDE~MYLAN~25MG;80MG~A~070947~001~AB~Apr 1, 1987~Yes~RX~
RIDE AND HYDROCHLOROTHIAZIDE~PLIVA~25MG;40MG~A~072042~001~AB~Mar 14, 1988~No~RX~
PLIVA INC
RIDE AND HYDROCHLOROTHIAZIDE~PLIVA~25MG;80MG~A~072043~001~AB~Mar 14, 1988~No~RX~
PLIVA INC
RIDE AND HYDROCHLOROTHIAZIDE~SANDOZ~25MG;40MG~A~071060~001~~Aug 26, 1987~No~DISC
N~SANDOZ INC
RIDE AND HYDROCHLOROTHIAZIDE~SANDOZ~25MG;80MG~A~071061~001~~Aug 26, 1987~No~DISC
N~SANDOZ INC
RIDE AND HYDROCHLOROTHIAZIDE~WARNER CHILCOTT~25MG;40MG~A~071771~001~~Jan 26, 198
RIDE AND HYDROCHLOROTHIAZIDE~WARNER CHILCOTT~25MG;80MG~A~071772~001~~Jan 26, 198
RIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~25MG;40MG~A~070301~001~~Apr 18, 1986~No
RIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~25MG;40MG~A~071498~001~~Dec 18, 1991~No
RIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~25MG;80MG~A~070305~001~~Apr 18, 1986~No
RIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~25MG;80MG~A~071501~001~~Dec 18, 1991~No
CISAPRIDE MONOHYDRATE~TABLET;ORAL~PROPULSID~JANSSEN PHARMS~EQ 10MG BASE~N~020210
~001~~Jul 29, 1993~No~DISCN~JANSSEN PHARMACEUTICALS INC
CISAPRIDE MONOHYDRATE~TABLET;ORAL~PROPULSID~JANSSEN PHARMS~EQ 20MG BASE~N~020210
~002~~Dec 23, 1993~No~DISCN~JANSSEN PHARMACEUTICALS INC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~ABBOTT~50MG~A~084075~001~~Approved
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~ACTAVIS ELIZABETH~50MG~A~080172~00
1~BD~Approved Prior to Jan 1, 1982~No~RX~ACTAVIS ELIZABETH LLC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~ANABOLIC~50MG~A~080285~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~ANABOLIC INC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~ANI PHARMS INC~50MG~A~080215~001~~
Approved Prior to Jan 1, 1982~No~DISCN~ANI PHARMACEUTICALS INC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~DAVA PHARMS INC~50MG~N~006188~001~
BD~Approved Prior to Jan 1, 1982~Yes~RX~DAVA PHARMACEUTICALS INC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~HALSEY~50MG~A~080015~001~~Approved
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~HIKMA PHARMS LLC~50MG~A~080154~001
~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTICALS LLC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~IMPAX LABS~50MG~A~080159~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~LANNETT~50MG~A~080016~001~~Approve
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~LILLY~50MG~N~006213~001~~Approved
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~MUTUAL PHARM~50MG~A~083982~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~PERRIGO~50MG~A~084543~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~L PERRIGO CO
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~TABLICAPS~50MG~A~080840~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~WATSON LABS~50MG~A~080932~001~~App
roved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
PROPYLTHIOURACIL~TABLET;ORAL~PROPYLTHIOURACIL~WATSON LABS~50MG~A~085201~001~~App
FINASTERIDE~TABLET;ORAL~PROSCAR~MERCK~5MG~N~020180~001~AB~Jun 19, 1992~Yes~RX~ME
RCK AND CO INC
ESTAZOLAM~TABLET;ORAL~PROSOM~ABBOTT~1MG **Federal Register determination that pr
oduct was not discontinued or withdrawn for safety or efficacy reasons**~N~01908
0~001~~Dec 26, 1990~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
ESTAZOLAM~TABLET;ORAL~PROSOM~ABBOTT~2MG **Federal Register determination that pr
oduct was not discontinued or withdrawn for safety or efficacy reasons**~N~01908
0~002~~Dec 26, 1990~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
PRALIDOXIME CHLORIDE~TABLET;ORAL~PROTOPAM CHLORIDE~WYETH AYERST~500MG~N~014122~0
METRONIDAZOLE~TABLET;ORAL~PROTOSTAT~ORTHO MCNEIL PHARM~250MG~N~018871~001~~Mar 2
, 1983~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
METRONIDAZOLE~TABLET;ORAL~PROTOSTAT~ORTHO MCNEIL PHARM~500MG~N~018871~002~~Mar 2
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~PROTRIPTYLINE HYDROCHLORIDE~EPIC PHARMA
LLC~5MG~A~202220~001~AB~Nov 19, 2012~No~RX~EPIC PHARMA LLC
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~PROTRIPTYLINE HYDROCHLORIDE~EPIC PHARMA
LLC~10MG~A~202220~002~AB~Nov 19, 2012~No~RX~EPIC PHARMA LLC
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~PROTRIPTYLINE HYDROCHLORIDE~ROXANE~5MG~A
~078913~001~AB~Sep 16, 2008~No~RX~ROXANE LABORATORIES INC
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~PROTRIPTYLINE HYDROCHLORIDE~ROXANE~10MG~
A~078913~002~AB~Sep 16, 2008~No~RX~ROXANE LABORATORIES INC
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~PROTRIPTYLINE HYDROCHLORIDE~SIGMAPHARM L
ABS LLC~5MG~A~090462~001~AB~May 3, 2010~No~RX~SIGMAPHARM LABORATORIES LLC
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~PROTRIPTYLINE HYDROCHLORIDE~SIGMAPHARM L
ABS LLC~10MG~A~090462~002~AB~May 3, 2010~No~RX~SIGMAPHARM LABORATORIES LLC
ALBUTEROL SULFATE~TABLET;ORAL~PROVENTIL~SCHERING~EQ 2MG BASE~N~017853~001~~May 7
ALBUTEROL SULFATE~TABLET;ORAL~PROVENTIL~SCHERING~EQ 4MG BASE~N~017853~002~~May 7
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~PROVERA~PHARMACIA AND UPJOHN~2.5MG~N~011
839~001~AB~Approved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~PROVERA~PHARMACIA AND UPJOHN~5MG~N~01183

9~003~AB~Approved Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
MEDROXYPROGESTERONE ACETATE~TABLET;ORAL~PROVERA~PHARMACIA AND UPJOHN~10MG~N~0118
39~004~AB~Approved Prior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
MODAFINIL~TABLET;ORAL~PROVIGIL~CEPHALON~100MG~N~020717~001~AB~Dec 24, 1998~No~RX
~CEPHALON INC
MODAFINIL~TABLET;ORAL~PROVIGIL~CEPHALON~200MG~N~020717~002~AB~Dec 24, 1998~Yes~R
X~CEPHALON INC
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~PROZAC~LILLY~EQ 10MG BASE~N~020974~001~~Mar
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~PROZAC~LILLY~EQ 20MG BASE~N~020974~002~~Mar
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~PSEUDOEPHE
DRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE~SANDOZ~60MG;2.5MG~A~088193~00
MERCAPTOPURINE~TABLET;ORAL~PURINETHOL~TEVA~50MG~N~009053~002~~Approved Prior to
Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
PYRAZINAMIDE~TABLET;ORAL~PYRAZINAMIDE~DAVA PHARMS INC~500MG~A~080157~001~AB~Appr
oved Prior to Jan 1, 1982~Yes~RX~DAVA PHARMACEUTICALS INC
PYRAZINAMIDE~TABLET;ORAL~PYRAZINAMIDE~MIKART~500MG~A~081319~001~AB~Jun 30, 1992~
No~RX~MIKART INC
PYRIDOSTIGMINE BROMIDE~TABLET;ORAL~PYRIDOSTIGMINE BROMIDE~BARR~30MG~A~040512~002
~~Jul 20, 2005~No~DISCN~BARR LABORATORIES INC
PYRIDOSTIGMINE BROMIDE~TABLET;ORAL~PYRIDOSTIGMINE BROMIDE~BARR~60MG~A~040512~001
~~Oct 8, 2003~No~DISCN~BARR LABORATORIES INC
PYRIDOSTIGMINE BROMIDE~TABLET;ORAL~PYRIDOSTIGMINE BROMIDE~COREPHARMA~60MG~A~0404
57~001~~Dec 26, 2002~No~DISCN~COREPHARMA LLC
PYRIDOSTIGMINE BROMIDE~TABLET;ORAL~PYRIDOSTIGMINE BROMIDE~IMPAX LABS~60MG~A~0405
02~001~AB~Apr 24, 2003~No~RX~IMPAX LABORATORIES INC
PYRIDOSTIGMINE BROMIDE~TABLET;ORAL~PYRIDOSTIGMINE BROMIDE~SOLVAY~30MG~A~089572~0
01~~Nov 27, 1990~No~DISCN~SOLVAY PHARMACEUTICALS
PYRIDOSTIGMINE BROMIDE~TABLET;ORAL~PYRIDOSTIGMINE BROMIDE~US ARMY~30MG~N~020414~
001~~Feb 5, 2003~No~DISCN~UNITED STATES ARMY OFFICE SURGEON GENERAL
PYRILAMINE MALEATE~TABLET;ORAL~PYRILAMINE MALEATE~IMPAX LABS~25MG~A~080808~001~~
Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
PYRILAMINE MALEATE~TABLET;ORAL~PYRILAMINE MALEATE~WATSON LABS~25MG~A~085231~001~
ASPIRIN; MEPROBAMATE~TABLET;ORAL~Q-GESIC~QUANTUM PHARMICS~325MG;200MG~A~088740~0
01~~Jun 1, 1984~No~DISCN~QUANTUM PHARMICS LTD
DIAZEPAM~TABLET;ORAL~Q-PAM~QUANTUM PHARMICS~2MG~A~070423~001~~Dec 12, 1985~No~DI
DIAZEPAM~TABLET;ORAL~Q-PAM~QUANTUM PHARMICS~2MG~A~072431~001~~Apr 29, 1988~No~DI
DIAZEPAM~TABLET;ORAL~Q-PAM~QUANTUM PHARMICS~5MG~A~070424~001~~Dec 12, 1985~No~DI
DIAZEPAM~TABLET;ORAL~Q-PAM~QUANTUM PHARMICS~5MG~A~072432~001~~Apr 29, 1988~No~DI
DIAZEPAM~TABLET;ORAL~Q-PAM~QUANTUM PHARMICS~10MG~A~070425~001~~Dec 12, 1985~No~D
ISCN~QUANTUM PHARMICS LTD
DIAZEPAM~TABLET;ORAL~Q-PAM~QUANTUM PHARMICS~10MG~A~072433~001~~Apr 29, 1988~No~D
ISCN~QUANTUM PHARMICS LTD
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~QUARTETTE~TEVA BRANDED PHARM~0.02M
G,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A~N~204061~001~~Mar 28, 2013~Yes~
RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~QUASENSE~WATSON LABS~0.03MG;0.15MG
CHOLESTYRAMINE~TABLET;ORAL~QUESTRAN~APOTHECON~EQ 1GM RESIN~A~073403~001~~Apr 28,
CHOLESTYRAMINE~TABLET;ORAL~QUESTRAN~APOTHECON~EQ 800MG RESIN~A~073403~002~~Dec 2
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ACCORD HLTHCARE~EQ 25MG BASE

~A~202152~001~AB~Mar 27, 2012~No~RX~ACCORD HEALTHCARE INC
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ACCORD HLTHCARE~EQ 50MG BASE
~A~202152~002~AB~Mar 27, 2012~No~RX~ACCORD HEALTHCARE INC
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ACCORD HLTHCARE~EQ 100MG BAS
E~A~202152~003~AB~Mar 27, 2012~No~RX~ACCORD HEALTHCARE INC
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ACTAVIS GRP PTC~EQ 25MG BASE
~A~201762~001~AB~Feb 27, 2013~No~RX~ACTAVIS GROUP PTC EHF
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ACTAVIS GRP PTC~EQ 50MG BASE
~A~201762~002~AB~Feb 27, 2013~No~RX~ACTAVIS GROUP PTC EHF
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ACTAVIS GRP PTC~EQ 100MG BAS
E~A~201762~003~AB~Feb 27, 2013~No~RX~ACTAVIS GROUP PTC EHF
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ALEMBIC PHARMS LTD~EQ 25MG B
ASE~A~203390~001~AB~Oct 28, 2014~No~RX~ALEMBIC PHARMACEUTICALS LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ALEMBIC PHARMS LTD~EQ 50MG B
ASE~A~203390~002~AB~Oct 28, 2014~No~RX~ALEMBIC PHARMACEUTICALS LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ALEMBIC PHARMS LTD~EQ 100MG
BASE~A~203390~003~AB~Oct 28, 2014~No~RX~ALEMBIC PHARMACEUTICALS LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ALKEM LABS LTD~EQ 25MG BASE~
A~201504~001~AB~Feb 12, 2013~No~RX~ALKEM LABORATORIES LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ALKEM LABS LTD~EQ 50MG BASE~
A~201504~002~AB~Feb 12, 2013~No~RX~ALKEM LABORATORIES LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ALKEM LABS LTD~EQ 100MG BASE
~A~201504~003~AB~Feb 12, 2013~No~RX~ALKEM LABORATORIES LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~APOTEX INC~EQ 25MG BASE~A~09

QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~AUROBINDO PHARMA LTD~EQ 25MG
BASE~A~091388~001~AB~Mar 27, 2012~No~RX~AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~AUROBINDO PHARMA LTD~EQ 50MG
BASE~A~091388~002~AB~Mar 27, 2012~No~RX~AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~AUROBINDO PHARMA LTD~EQ 100M
G BASE~A~091388~003~AB~Mar 27, 2012~No~RX~AUROBINDO PHARMA LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~DR REDDYS LABS LTD~EQ 25MG B
ASE~A~077380~001~AB~Mar 27, 2012~No~RX~DR REDDYS LABORATORIES LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~DR REDDYS LABS LTD~EQ 50MG B
ASE~A~077380~002~AB~Mar 27, 2012~No~RX~DR REDDYS LABORATORIES LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~DR REDDYS LABS LTD~EQ 100MG
BASE~A~077380~003~AB~Mar 27, 2012~No~RX~DR REDDYS LABORATORIES LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~JUBILANT GENERICS~EQ 25MG BA
SE~A~203150~001~AB~Nov 26, 2013~No~RX~JUBILANT GENERICS LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~LUPIN LTD~EQ 25MG BASE~A~201
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~MYLAN PHARMS INC~EQ 25MG BAS
E~A~090323~001~AB~Mar 27, 2012~No~RX~MYLAN PHARMACEUTICALS INC
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~ROXANE~EQ 25MG BASE~A~090120
~001~AB~Mar 27, 2012~No~RX~ROXANE LABORATORIES INC
~001~AB~Mar 27, 2012~No~RX~ROXANE LABORATORIES INC
9~002~AB~Mar 27, 2012~No~RX~ROXANE LABORATORIES INC
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~SANDOZ~EQ 25MG BASE~A~078679

QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~SUN PHARMA GLOBAL~EQ 25MG BA
SE~A~201190~001~AB~Mar 27, 2012~No~RX~SUN PHARMA GLOBAL FZE
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~SUN PHARMA GLOBAL~EQ 50MG BA
SE~A~201190~002~AB~Mar 27, 2012~No~RX~SUN PHARMA GLOBAL FZE
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~SUN PHARMA GLOBAL~EQ 100MG B
ASE~A~201190~003~AB~Mar 27, 2012~No~RX~SUN PHARMA GLOBAL FZE
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~TEVA PHARMS~EQ 25MG BASE~A~0
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~TEVA PHARMS~EQ 50MG BASE~A~0
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~TEVA PHARMS~EQ 100MG BASE~A~
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~TORRENT PHARMS LTD~EQ 25MG B
ASE~A~200363~001~AB~Mar 27, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~TORRENT PHARMS LTD~EQ 50MG B
ASE~A~200363~002~AB~Mar 27, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
QUETIAPINE FUMARATE~TABLET;ORAL~QUETIAPINE FUMARATE~TORRENT PHARMS LTD~EQ 100MG
BASE~A~200363~003~AB~Mar 27, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
THEOPHYLLINE~TABLET;ORAL~QUIBRON-T~MONARCH PHARMS~300MG~A~088656~001~~Aug 22, 19
PIPERACETAZINE~TABLET;ORAL~QUIDE~DOW PHARM~10MG~N~013615~001~~Approved Prior to
Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL CORP SUB DOW CHEMICAL CO
PIPERACETAZINE~TABLET;ORAL~QUIDE~DOW PHARM~25MG~N~013615~002~~Approved Prior to
Jan 1, 1982~No~DISCN~DOW PHARMACEUTICAL CORP SUB DOW CHEMICAL CO
QUINIDINE GLUCONATE~TABLET;ORAL~QUINACT~BAYER HLTHCARE~266MG~A~085978~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
QUINIDINE GLUCONATE~TABLET;ORAL~QUINACT~BAYER HLTHCARE~400MG~A~086099~001~~Appro

ved Prior to Jan 1, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~ACTAVIS ELIZABETH~EQ
5MG BASE~A~076459~001~~Dec 22, 2004~No~DISCN~ACTAVIS ELIZABETH LLC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~ACTAVIS LABS FL INC~
EQ 5MG BASE~A~076049~001~AB~Jan 14, 2005~No~RX~ACTAVIS LABORATORIES FL INC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~APOTEX INC~EQ 5MG BA
SE~A~076240~001~~Jan 26, 2006~No~DISCN~APOTEX INC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~APOTEX INC~EQ 10MG B
ASE~A~076240~002~~Jan 26, 2006~No~DISCN~APOTEX INC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~AUROBINDO PHARMA LTD
~EQ 5MG BASE~A~202725~001~AB~Apr 29, 2013~No~RX~AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~INVAGEN PHARMS~EQ 5M
G BASE~A~078457~001~AB~Aug 24, 2007~No~RX~INVAGEN PHARMACEUTICALS INC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~INVAGEN PHARMS~EQ 10
MG BASE~A~078457~002~AB~Aug 24, 2007~No~RX~INVAGEN PHARMACEUTICALS INC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~LUPIN~EQ 5MG BASE~A~
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~LUPIN~EQ 10MG BASE~A
~077690~002~AB~Jun 20, 2006~No~RX~LUPIN LTD
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~MYLAN~EQ 5MG BASE~A~
076036~001~~Jan 28, 2005~No~DISCN~MYLAN PHARMACEUTICALS INC
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~MYLAN~EQ 5MG BASE~A~
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~MYLAN~EQ 10MG BASE~A
~076036~002~~Jan 28, 2005~No~DISCN~MYLAN PHARMACEUTICALS INC
~076694~002~AB~Dec 23, 2004~No~RX~MYLAN PHARMACEUTICALS INC

QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~RANBAXY~EQ 5MG BASE~
A~076607~001~AB~Dec 15, 2004~No~RX~RANBAXY LABORATORIES LTD
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~RANBAXY~EQ 10MG BASE
~A~076607~002~AB~Dec 15, 2004~No~RX~RANBAXY LABORATORIES LTD
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~SANDOZ~EQ 5MG BASE~A
~076803~001~~Mar 2, 2005~No~DISCN~SANDOZ
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~SANDOZ~EQ 10MG BASE~
A~076803~002~~Mar 2, 2005~No~DISCN~SANDOZ
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~SUN PHARM INDS LTD~E
Q 5MG BASE~A~090800~001~AB~Jun 18, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~TEVA~EQ 5MG BASE~A~0
QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE~TEVA~EQ 10MG BASE~A~
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINAPRIL HYDROCHLORIDE
AND HYDROCHLOROTHIAZIDE~APOTEX CORP~12.5MG;EQ 10MG BASE~A~091524~001~AB~Mar 12,
2013~No~RX~APOTEX CORP
AND HYDROCHLOROTHIAZIDE~APOTEX CORP~12.5MG;EQ 20MG BASE~A~091524~002~AB~Mar 12,
AND HYDROCHLOROTHIAZIDE~APOTEX CORP~25MG;EQ 20MG BASE~A~091524~003~AB~Mar 12, 2
AND HYDROCHLOROTHIAZIDE~AUROBINDO PHARMA~12.5MG;EQ 10MG BASE~A~078450~001~AB~Au
g 24, 2007~No~RX~AUROBINDO PHARMA LTD
AND HYDROCHLOROTHIAZIDE~AUROBINDO PHARMA~12.5MG;EQ 20MG BASE~A~078450~002~AB~Au
g 24, 2007~No~RX~AUROBINDO PHARMA LTD
AND HYDROCHLOROTHIAZIDE~AUROBINDO PHARMA~25MG;EQ 20MG BASE~A~078450~003~AB~Aug
AND HYDROCHLOROTHIAZIDE~INVAGEN PHARMS~12.5MG;10MG~A~201356~001~AB~Apr 20, 2011
AND HYDROCHLOROTHIAZIDE~INVAGEN PHARMS~12.5MG;20MG~A~201356~002~AB~Apr 20, 2011

AND HYDROCHLOROTHIAZIDE~INVAGEN PHARMS~25MG;20MG~A~201356~003~AB~Apr 20, 2011~N
o~RX~INVAGEN PHARMACEUTICALS INC
AND HYDROCHLOROTHIAZIDE~MYLAN~12.5MG;EQ 10MG BASE~A~077093~001~AB~Mar 28, 2005~
AND HYDROCHLOROTHIAZIDE~MYLAN~12.5MG;EQ 20MG BASE~A~077093~002~AB~Mar 28, 2005~
AND HYDROCHLOROTHIAZIDE~MYLAN~25MG;EQ 20MG BASE~A~077093~003~AB~Mar 28, 2005~No
AND HYDROCHLOROTHIAZIDE~RANBAXY~12.5MG;EQ 10MG BASE~A~078211~001~AB~Mar 4, 2009
~No~RX~RANBAXY LABORATORIES LTD
AND HYDROCHLOROTHIAZIDE~RANBAXY~12.5MG;EQ 20MG BASE~A~078211~002~AB~Mar 4, 2009
~No~RX~RANBAXY LABORATORIES LTD
AND HYDROCHLOROTHIAZIDE~RANBAXY~25MG;EQ 20MG BASE~A~078211~003~AB~Mar 4, 2009~N
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE~TABLET;ORAL~QUINARETIC~GAVIS PHARMS
~12.5MG;EQ 10MG BASE~A~076374~001~AB~Mar 31, 2004~No~RX~GAVIS PHARMACEUTICALS LL
C
~12.5MG;EQ 20MG BASE~A~076374~002~AB~Mar 31, 2004~No~RX~GAVIS PHARMACEUTICALS LL
C
~25MG;EQ 20MG BASE~A~076374~003~AB~Mar 31, 2004~No~RX~GAVIS PHARMACEUTICALS LLC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~BARR~200MG~A~084177~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~CONTRACT PHARMACAL~200MG~A~08380
8~001~~Approved Prior to Jan 1, 1982~No~DISCN~CONTRACT PHARMACAL CORP
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~DAVA PHARMS INC~200MG~A~087011~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~DAVA PHARMACEUTICALS INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~ELKINS SINN~200MG~A~083622~001~~
Approved Prior to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~EVERYLIFE~200MG~A~083439~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~EVERYLIFE
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~HALSEY~200MG~A~083583~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~HIKMA PHARMS LLC~200MG~A~083862~
001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTICALS LLC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~IMPAX LABS~200MG~A~083347~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~IVAX SUB TEVA PHARMS~200MG~A~084
549~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEV
A PHARMACEUTICALS USA
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~KING PHARMS~200MG~A~085175~001~~
Approved Prior to Jan 1, 1982~No~DISCN~KING PHARMACEUTICALS INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~KV PHARM~200MG~A~085276~001~~App
roved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~LANNETT~200MG~A~083743~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~LEDERLE~200MG~A~086176~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~LILLY~200MG~A~085038~001~~Approv
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~MUTUAL PHARM~100MG~A~081029~001~

~Apr 14, 1989~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
AB~Apr 14, 1989~No~RX~MUTUAL PHARMACEUTICAL CO INC
AB~Apr 14, 1989~No~RX~MUTUAL PHARMACEUTICAL CO INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~PERRIGO~200MG~A~085322~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~L PERRIGO CO
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~PHARMAVITE~200MG~A~084627~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~PHARMAVITE PHARMACEUTICALS
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~PUREPAC PHARM~200MG~A~084003~001
~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~ROXANE~200MG~A~083640~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~ROXANE~300MG~A~085632~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~SANDOZ~200MG~A~084631~001~~Appro
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~SANDOZ~200MG~A~084914~001~~Appro
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~SANDOZ~200MG~A~088072~002~AB~App
roved Prior to Jan 1, 1982~No~RX~SANDOZ INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~SANDOZ~300MG~A~088072~001~AB~Sep
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~SANDOZ~300MG~A~089839~001~~Sep 2
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~SCHERER LABS~200MG~A~085068~001~
~Approved Prior to Jan 1, 1982~No~DISCN~SCHERER LABORATORIES INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~SUPERPHARM~200MG~A~088973~001~~A
pr 10, 1985~No~DISCN~SUPERPHARM CORP
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~USL PHARMA~200MG~A~087837~001~~A
pr 14, 1982~No~DISCN~USL PHARMA INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~VALEANT PHARM INTL~200MG~A~08339
3~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIO
NAL
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~VANGARD~200MG~A~087909~001~~Jul
13, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~VINTAGE PHARMS~200MG~A~083963~00
1~~Approved Prior to Jan 1, 1982~No~DISCN~VINTAGE PHARMACEUTICALS INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~WARNER CHILCOTT~200MG~A~083879~0
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~WATSON LABS~100MG~A~085584~001~~
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~WATSON LABS~200MG~A~083288~001~A
B~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~WATSON LABS~200MG~A~085140~002~~
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~WATSON LABS~300MG~A~085583~001~A
B~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
QUINIDINE SULFATE~TABLET;ORAL~QUINIDINE SULFATE~WHITEWORTH TOWN PLSN~200MG~A~085
QUINIDINE SULFATE~TABLET;ORAL~QUINORA~KEY PHARMS~200MG~A~083576~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP
QUINIDINE SULFATE~TABLET;ORAL~QUINORA~SCHERING~300MG~A~085222~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~SCHERING CORP
RALOXIFENE HYDROCHLORIDE~TABLET;ORAL~RALOXIFENE HYDROCHLORIDE~INVAGEN PHARMS~60M
G~A~090842~001~AB~Sep 24, 2014~No~RX~INVAGEN PHARMACEUTICALS INC
RALOXIFENE HYDROCHLORIDE~TABLET;ORAL~RALOXIFENE HYDROCHLORIDE~TEVA PHARMS USA~60
MG~A~078193~001~AB~Mar 4, 2014~No~RX~TEVA PHARMACEUTICALS USA
RALOXIFENE HYDROCHLORIDE~TABLET;ORAL~RALOXIFENE HYDROCHLORIDE~WATSON LABS INC~60
MG~A~200825~001~AB~Jan 21, 2015~No~RX~WATSON LABORATORIES INC

RAMELTEON~TABLET;ORAL~RAMELTEON~TEVA PHARMS USA~8MG~A~091693~001~AB~Jul 26, 2013
RAMIPRIL~TABLET;ORAL~RAMIPRIL~MYLAN PHARMS INC~1.25MG~A~090650~001~AB~Jun 30, 20
RAMIPRIL~TABLET;ORAL~RAMIPRIL~MYLAN PHARMS INC~2.5MG~A~090650~002~AB~Jun 30, 201
RAMIPRIL~TABLET;ORAL~RAMIPRIL~MYLAN PHARMS INC~5MG~A~090650~003~AB~Jun 30, 2011~
RAMIPRIL~TABLET;ORAL~RAMIPRIL~MYLAN PHARMS INC~10MG~A~090650~004~AB~Jun 30, 2011
RAMIPRIL~TABLET;ORAL~RAMIPRIL~ZYDUS PHARMS USA INC~1.25MG~A~090697~001~AB~Sep 24
RAMIPRIL~TABLET;ORAL~RAMIPRIL~ZYDUS PHARMS USA INC~2.5MG~A~090697~002~AB~Sep 24,
RAMIPRIL~TABLET;ORAL~RAMIPRIL~ZYDUS PHARMS USA INC~5MG~A~090697~003~AB~Sep 24, 2
RAMIPRIL~TABLET;ORAL~RAMIPRIL~ZYDUS PHARMS USA INC~10MG~A~090697~004~AB~Sep 24,
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~AMNEAL PHARMS NY~E
Q 150MG BASE~A~077824~001~AB~Oct 13, 2006~No~RX~AMNEAL PHARMACEUTICALS NY LLC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~AMNEAL PHARMS NY~E
Q 300MG BASE~A~077824~002~AB~Oct 13, 2006~No~RX~AMNEAL PHARMACEUTICALS NY LLC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~APOTEX~EQ 150MG BA
SE~A~074680~001~AB~Sep 12, 1997~No~RX~APOTEX INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~APOTEX~EQ 300MG BA
SE~A~074680~002~AB~Sep 12, 1997~No~RX~APOTEX INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~APOTEX INC~EQ 150M
G BASE~A~200172~001~~May 31, 2012~No~OTC~APOTEX INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~BOEHRINGER INGELHE
IM~EQ 150MG BASE~A~074662~001~~Aug 29, 1997~No~DISCN~BOEHRINGER INGELHEIM CORP
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~BOEHRINGER INGELHE
IM~EQ 300MG BASE~A~074662~002~~Aug 29, 1997~No~DISCN~BOEHRINGER INGELHEIM CORP
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~CONTRACT PHARMACAL
~EQ 75MG BASE~A~075094~001~~Jun 21, 1999~No~OTC~CONTRACT PHARMACAL CORP
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~DR REDDYS LABS INC
~EQ 150MG BASE~A~076705~001~AB~Jul 27, 2005~No~RX~DR REDDYS LABORATORIES INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~DR REDDYS LABS LTD
~EQ 75MG BASE~A~075294~001~~Mar 28, 2000~No~OTC~DR REDDYS LABORATORIES LTD
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~DR REDDYS LABS LTD
~EQ 150MG BASE~A~078192~001~~Aug 31, 2007~No~OTC~DR REDDYS LABORATORIES LTD
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~GLENMARK GENERICS~
EQ 150MG BASE~A~078542~001~AB~Nov 19, 2008~No~RX~GLENMARK GENERICS INC USA
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~GLENMARK GENERICS~
EQ 300MG BASE~A~078542~002~AB~Nov 19, 2008~No~RX~GLENMARK GENERICS INC USA
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~EQ 75MG BASE~A~075296~001~~Jan 14, 2000~No~OTC~IVAX PHARMACEUTICALS INC SUB T
MS~EQ 150MG BASE~A~075165~001~AB~Sep 30, 1998~No~RX~IVAX PHARMACEUTICALS INC SUB
MS~EQ 300MG BASE~A~075165~002~AB~Sep 30, 1998~No~RX~IVAX PHARMACEUTICALS INC SUB
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~MYLAN~EQ 75MG BASE
~A~075497~001~~Jan 14, 2000~No~OTC~MYLAN PHARMACEUTICALS INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~MYLAN~EQ 150MG BAS
E~A~074023~001~AB~Aug 22, 1997~No~RX~MYLAN PHARMACEUTICALS INC

E~A~074552~001~~Jul 30, 1998~No~DISCN~MYLAN PHARMACEUTICALS INC
E~A~074023~002~AB~Aug 22, 1997~No~RX~MYLAN PHARMACEUTICALS INC
E~A~074552~002~~Jul 30, 1998~No~DISCN~MYLAN PHARMACEUTICALS INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~PAR PHARM~EQ 150MG
BASE~A~075180~001~AB~Jan 28, 1999~No~RX~PAR PHARMACEUTICAL INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~PAR PHARM~EQ 300MG
BASE~A~075180~002~AB~Jan 28, 1999~No~RX~PAR PHARMACEUTICAL INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~PERRIGO~EQ 75MG BA
SE~A~076195~001~~Aug 30, 2002~No~OTC~L PERRIGO CO
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~PERRIGO R AND D~EQ
150MG BASE~A~091429~001~~May 11, 2011~No~OTC~PERRIGO R AND D CO
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~PERRIGO R AND D~EQ
150MG BASE~A~091429~002~~May 11, 2011~No~OTC~PERRIGO R AND D CO
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~RANBAXY~EQ 75MG BA
SE~A~075132~001~~Jan 14, 2000~No~DISCN~RANBAXY LABORATORIES LTD
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~RANBAXY~EQ 75MG BA
SE~A~075254~001~~Jan 14, 2000~No~DISCN~RANBAXY PHARMACEUTICALS INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~RANBAXY~EQ 150MG B
ASE~A~075000~001~~Jan 30, 1998~No~DISCN~RANBAXY PHARMACEUTICALS INC
ASE~A~075439~001~~Apr 19, 2000~No~DISCN~RANBAXY LABORATORIES LTD
ASE~A~075000~002~~Jan 30, 1998~No~DISCN~RANBAXY PHARMACEUTICALS INC
ASE~A~075439~002~~Apr 19, 2000~No~DISCN~RANBAXY LABORATORIES LTD
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~SANDOZ~EQ 75MG BAS
E~A~075519~001~~Sep 26, 2002~No~DISCN~SANDOZ INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~SANDOZ~EQ 150MG BA
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~SANDOZ~EQ 300MG BA
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~SHASUN CHEMS~EQ 75
MG BASE~A~201745~001~~Feb 29, 2012~No~OTC~SHASUN CHEMICALS AND DRUGS LTD
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~SVADS HOLDINGS SA~
EQ 150MG BASE~A~200536~001~~Jun 28, 2011~No~OTC~SVADS HOLDINGS SA
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~TEVA~EQ 150MG BASE
~A~074488~001~AB~Jul 31, 1997~No~RX~TEVA PHARMACEUTICALS USA INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~TEVA~EQ 300MG BASE
~A~074488~002~AB~Jul 31, 1997~No~RX~TEVA PHARMACEUTICALS USA INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~TORPHARM~EQ 75MG B
ASE~A~075167~001~~May 4, 2000~No~OTC~TORPHARM INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~WATSON LABS~EQ 75M
G BASE~A~075212~001~~Jan 14, 2000~No~DISCN~WATSON LABORATORIES INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~WATSON LABS~EQ 150
MG BASE~A~074864~001~~Oct 20, 1997~No~DISCN~WATSON LABORATORIES INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~WATSON LABS~EQ 300
MG BASE~A~074864~002~~Oct 20, 1997~No~DISCN~WATSON LABORATORIES INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~WATSON LABS INC~EQ
150MG BASE~A~077426~001~~Dec 19, 2005~No~DISCN~WATSON LABORATORIES INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~WATSON LABS INC~EQ
300MG BASE~A~077426~002~~Dec 19, 2005~No~DISCN~WATSON LABORATORIES INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~RANITIDINE HYDROCHLORIDE~WOCKHARDT~EQ 75MG
BASE~A~076760~001~~Feb 24, 2006~No~OTC~WOCKHARDT LTD
BASE~A~078884~001~~Jul 31, 2008~No~DISCN~WOCKHARDT LTD
BASE~A~075208~001~AB~Dec 17, 1998~No~RX~WOCKHARDT AMERICAS INC

BASE~A~078653~001~~Nov 26, 2007~No~DISCN~WOCKHARDT LTD
BASE~A~078701~001~~Nov 12, 2009~No~DISCN~WOCKHARDT LTD
BASE~A~075208~002~AB~Dec 17, 1998~No~RX~WOCKHARDT AMERICAS INC
BASE~A~078701~002~~Dec 11, 2009~No~DISCN~WOCKHARDT LTD
SIROLIMUS~TABLET;ORAL~RAPAMUNE~PF PRISM CV~0.5MG~N~021110~004~AB~Jan 25, 2010~No
~RX~PF PRISM CV
SIROLIMUS~TABLET;ORAL~RAPAMUNE~PF PRISM CV~1MG~N~021110~001~AB~Aug 25, 2000~No~R
X~PF PRISM CV
SIROLIMUS~TABLET;ORAL~RAPAMUNE~PF PRISM CV~2MG~N~021110~002~AB~Aug 22, 2002~Yes~
RX~PF PRISM CV
SIROLIMUS~TABLET;ORAL~RAPAMUNE~PF PRISM CV~5MG **Federal Register determination
N~021110~003~~Feb 23, 2004~No~DISCN~PF PRISM CV
RASAGILINE MESYLATE~TABLET;ORAL~RASAGILINE MESYLATE~APOTEX INC~EQ 0.5MG BASE~A~2
RASAGILINE MESYLATE~TABLET;ORAL~RASAGILINE MESYLATE~APOTEX INC~EQ 1MG BASE~A~201
RASAGILINE MESYLATE~TABLET;ORAL~RASAGILINE MESYLATE~WATSON LABS INC~EQ 0.5MG BAS
E~A~201823~001~~Jul 1, 2013~No~DISCN~WATSON LABORATORIES INC
RASAGILINE MESYLATE~TABLET;ORAL~RASAGILINE MESYLATE~WATSON LABS INC~EQ 1MG BASE~
A~201823~002~~Jul 1, 2013~No~DISCN~WATSON LABORATORIES INC
RESERPINE~TABLET;ORAL~RAU-SED~BRISTOL MYERS SQUIBB~0.1MG~N~009357~001~~Approved
RESERPINE~TABLET;ORAL~RAU-SED~BRISTOL MYERS SQUIBB~1MG~N~009357~008~~Approved Pr
ior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUDIXIN~APOTHECON~50MG~N~008842~001~~Appr
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUDIXIN~APOTHECON~100MG~N~008842~002~~App
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUSERPIN~FERNDALE LABS~50MG~N~009926~002~
~Approved Prior to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUSERPIN~FERNDALE LABS~100MG~N~009926~004
~~Approved Prior to Jan 1, 1982~No~DISCN~FERNDALE LABORATORIES INC
ALSEROXYLON~TABLET;ORAL~RAUTENSIN~NOVARTIS~2MG~N~009215~001~~Approved Prior to J
an 1, 1982~No~DISCN~NOVARTIS CONSUMER HEALTH INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUVAL~PAL PAK~50MG~N~009108~002~~Approved
Prior to Jan 1, 1982~No~DISCN~PAL PAK INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUVAL~PAL PAK~100MG~N~009108~004~~Approve
d Prior to Jan 1, 1982~No~DISCN~PAL PAK INC
ALSEROXYLON~TABLET;ORAL~RAUWILOID~3M~2MG~N~008867~001~~Approved Prior to Jan 1,
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~BUNDY~50MG~N~009477~0
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~BUNDY~100MG~N~009477~
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~HALSEY~50MG~A~080498~
001~~Approved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~HALSEY~100MG~A~080498
~002~~Approved Prior to Jan 1, 1982~No~DISCN~HALSEY DRUG CO INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~IMPAX LABS~50MG~N~009
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~IMPAX LABS~100MG~N~00

RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~IVAX SUB TEVA PHARMS~
50MG~N~011521~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS I
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~IVAX SUB TEVA PHARMS~
100MG~N~011521~002~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~PUREPAC PHARM~50MG~A~
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~PUREPAC PHARM~100MG~A
~080842~002~~Approved Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~PVT FORM~50MG~A~08058
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~PVT FORM~100MG~A~0805
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~SOLVAY~50MG~A~080500~
001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~SOLVAY~100MG~A~080500
~002~~Approved Prior to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~TABLICAPS~50MG~A~0838
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~TABLICAPS~100MG~A~083
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~VALEANT PHARM INTL~50
MG~N~009668~001~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS
INTERNATIONAL
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~VALEANT PHARM INTL~10
0MG~N~009668~002~~Approved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS
INTERNATIONAL
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~WATSON LABS~50MG~A~08
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~RAUWOLFIA SERPENTINA~WATSON LABS~100MG~A~0
GREPAFLOXACIN HYDROCHLORIDE~TABLET;ORAL~RAXAR~OTSUKA~EQ 200MG BASE~N~020695~001~
~Nov 6, 1997~No~DISCN~OTSUKA PHARMACEUTICAL CO LTD
~May 14, 1998~No~DISCN~OTSUKA PHARMACEUTICAL CO LTD
~May 14, 1998~No~DISCN~OTSUKA PHARMACEUTICAL CO LTD
GALANTAMINE HYDROBROMIDE~TABLET;ORAL~RAZADYNE~JANSSEN PHARMS~EQ 4MG BASE~N~02116
9~001~AB~Feb 28, 2001~Yes~RX~JANSSEN PHARMACEUTICALS INC
9~002~AB~Feb 28, 2001~No~RX~JANSSEN PHARMACEUTICALS INC
69~003~AB~Feb 28, 2001~No~RX~JANSSEN PHARMACEUTICALS INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~REGLAN~ANI PHARMS~EQ 5MG BASE~N~017854~
002~AB~May 5, 1987~No~RX~ANI PHARMACEUTICALS INC
METOCLOPRAMIDE HYDROCHLORIDE~TABLET;ORAL~REGLAN~ANI PHARMS~EQ 10MG BASE~N~017854
~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~ANI PHARMACEUTICALS INC
CHLORTHALIDONE; RESERPINE~TABLET;ORAL~REGROTON~SANOFI AVENTIS US~50MG;0.25MG~N~0
CARISOPRODOL~TABLET;ORAL~RELA~SCHERING~350MG~N~012155~001~~Approved Prior to Jan
NABUMETONE~TABLET;ORAL~RELAFEN~SMITHKLINE BEECHAM~500MG~N~019583~001~~Dec 24, 19
NABUMETONE~TABLET;ORAL~RELAFEN~SMITHKLINE BEECHAM~750MG~N~019583~002~~Dec 24, 19
ELETRIPTAN HYDROBROMIDE~TABLET;ORAL~RELPAX~PFIZER IRELAND~EQ 20MG BASE~N~021016~
001~~Dec 26, 2002~No~RX~PFIZER IRELAND PHARMACEUTICALS
ELETRIPTAN HYDROBROMIDE~TABLET;ORAL~RELPAX~PFIZER IRELAND~EQ 40MG BASE~N~021016~
002~~Dec 26, 2002~Yes~RX~PFIZER IRELAND PHARMACEUTICALS

MIRTAZAPINE~TABLET;ORAL~REMERON~ORGANON USA INC~15MG~N~020415~001~AB~Jun 14, 199
6~Yes~RX~ORGANON USA INC
MIRTAZAPINE~TABLET;ORAL~REMERON~ORGANON USA INC~30MG~N~020415~002~AB~Jun 14, 199
6~No~RX~ORGANON USA INC
MIRTAZAPINE~TABLET;ORAL~REMERON~ORGANON USA INC~45MG~N~020415~003~AB~Mar 17, 199
7~No~RX~ORGANON USA INC
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~REMSED~BRISTOL MYERS SQUIBB~25MG~A~083176
~002~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB PHARMA CO
PROMETHAZINE HYDROCHLORIDE~TABLET;ORAL~REMSED~BRISTOL MYERS SQUIBB~50MG~A~083176
~001~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB PHARMA CO
SEVELAMER HYDROCHLORIDE~TABLET;ORAL~RENAGEL~GENZYME~400MG~N~021179~001~~Jul 12,
2000~No~RX~GENZYME CORP
SEVELAMER HYDROCHLORIDE~TABLET;ORAL~RENAGEL~GENZYME~800MG~N~021179~002~~Jul 12,
2000~Yes~RX~GENZYME CORP
POLYTHIAZIDE~TABLET;ORAL~RENESE~PFIZER~1MG~N~012845~001~~Approved Prior to Jan 1
, 1982~No~DISCN~PFIZER INC
POLYTHIAZIDE; RESERPINE~TABLET;ORAL~RENESE-R~PFIZER~2MG;0.25MG~N~013636~001~~App
roved Prior to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
SULFACYTINE~TABLET;ORAL~RENOQUID~GLENWOOD~250MG~N~017569~001~~Approved Prior to
Jan 1, 1982~No~DISCN~GLENWOOD INC
SPIRAPRIL HYDROCHLORIDE~TABLET;ORAL~RENORMAX~SCHERING~3MG~N~020240~001~~Dec 29,
1994~No~DISCN~SCHERING CORP
SEVELAMER CARBONATE~TABLET;ORAL~RENVELA~GENZYME~800MG~N~022127~001~~Oct 19, 2007
~Yes~RX~GENZYME CORP
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~ACTAVIS TOTOWA~0.5MG~A~090008~001~AB~Jan 22,
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~ACTAVIS TOTOWA~1MG~A~090008~002~AB~Jan 22, 2
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~ACTAVIS TOTOWA~2MG~A~090008~003~AB~Jan 22, 2
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~AUROBINDO PHARMA LTD~0.5MG~A~203820~001~AB~J
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~AUROBINDO PHARMA LTD~1MG~A~203820~002~AB~Jan
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~AUROBINDO PHARMA LTD~2MG~A~203820~003~AB~Jan
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~MYLAN PHARMS INC~0.5MG~A~090252~001~AB~Aug 2
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~MYLAN PHARMS INC~1MG~A~090252~002~AB~Jan 22,
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~MYLAN PHARMS INC~2MG~A~090252~003~AB~Jan 22,
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~PADDOCK LLC~0.5MG~A~201189~001~AB~Jul 17, 20
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~PADDOCK LLC~1MG~A~201189~002~AB~Jan 22, 2014
~No~RX~PADDOCK LABORATORIES LLC
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~PADDOCK LLC~2MG~A~201189~003~AB~Jan 22, 2014
~No~RX~PADDOCK LABORATORIES LLC
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~SANDOZ~0.5MG~A~078555~001~AB~Nov 22, 2013~No
~RX~SANDOZ INC
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~SANDOZ~1MG~A~078555~002~AB~Jan 22, 2014~No~R
X~SANDOZ INC
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~SANDOZ~2MG~A~078555~003~AB~Jan 22, 2014~No~R
X~SANDOZ INC
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~SUN PHARM INDS INC~1MG~A~077571~002~AB~Jul 1
REPAGLINIDE~TABLET;ORAL~REPAGLINIDE~SUN PHARM INDS INC~2MG~A~077571~003~AB~Jul 1
HYDROCODONE BITARTRATE; IBUPROFEN~TABLET;ORAL~REPREXAIN~AMNEAL PHARMS NY~2.5MG;2
00MG~A~076642~003~AB~Oct 19, 2007~No~RX~AMNEAL PHARMACEUTICALS NY LLC
HYDROCODONE BITARTRATE; IBUPROFEN~TABLET;ORAL~REPREXAIN~AMNEAL PHARMS NY~10MG;20
0MG~A~076642~004~AB~Oct 19, 2007~No~RX~AMNEAL PHARMACEUTICALS NY LLC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~REQUIP~GLAXOSMITHKLINE LLC~EQ 0.25MG BASE~N
~020658~001~AB~Sep 19, 1997~Yes~RX~GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~REQUIP~GLAXOSMITHKLINE LLC~EQ 0.5MG BASE~N~
020658~002~AB~Sep 19, 1997~No~RX~GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~REQUIP~GLAXOSMITHKLINE LLC~EQ 1MG BASE~N~02
0658~006~AB~Jan 27, 1999~No~RX~GLAXOSMITHKLINE LLC
0658~007~AB~Jan 27, 1999~No~RX~GLAXOSMITHKLINE LLC
DELAVIRDINE MESYLATE~TABLET;ORAL~RESCRIPTOR~VIIV HLTHCARE~100MG~N~020705~001~~Ap
r 4, 1997~No~RX~VIIV HEALTHCARE CO
DELAVIRDINE MESYLATE~TABLET;ORAL~RESCRIPTOR~VIIV HLTHCARE~200MG~N~020705~002~~Ju
l 14, 1999~Yes~RX~VIIV HEALTHCARE CO
RESERPINE~TABLET;ORAL~RESERPINE~BARR~0.25MG~A~080721~002~~Approved Prior to Jan
RESERPINE~TABLET;ORAL~RESERPINE~BELL PHARMA~0.1MG~A~083058~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~BELL PHARMACAL CORP
RESERPINE~TABLET;ORAL~RESERPINE~BELL PHARMA~0.25MG~A~083058~002~~Approved Prior
to Jan 1, 1982~No~DISCN~BELL PHARMACAL CORP
RESERPINE~TABLET;ORAL~RESERPINE~BUNDY~0.1MG~N~009663~001~~Approved Prior to Jan
RESERPINE~TABLET;ORAL~RESERPINE~BUNDY~0.25MG~N~009663~003~~Approved Prior to Jan
RESERPINE~TABLET;ORAL~RESERPINE~CYCLE PHARMS LTD~0.1MG~N~009859~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~CYCLE PHARMACEUTICALS LTD
RESERPINE~TABLET;ORAL~RESERPINE~CYCLE PHARMS LTD~0.25MG~N~009859~002~~Approved P
rior to Jan 1, 1982~No~DISCN~CYCLE PHARMACEUTICALS LTD
RESERPINE~TABLET;ORAL~RESERPINE~ELKINS SINN~0.1MG~A~083145~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
RESERPINE~TABLET;ORAL~RESERPINE~ELKINS SINN~0.25MG~A~083145~002~~Approved Prior
to Jan 1, 1982~No~DISCN~ELKINS SINN DIV AH ROBINS CO INC
RESERPINE~TABLET;ORAL~RESERPINE~EVERYLIFE~0.1MG~N~010441~001~~Approved Prior to
RESERPINE~TABLET;ORAL~RESERPINE~EVERYLIFE~1MG~N~010441~004~~Approved Prior to Ja
n 1, 1982~No~DISCN~EVERYLIFE
RESERPINE~TABLET;ORAL~RESERPINE~HALSEY~0.1MG~A~080457~002~~Approved Prior to Jan
RESERPINE~TABLET;ORAL~RESERPINE~HALSEY~0.25MG~A~080457~001~~Approved Prior to Ja

RESERPINE~TABLET;ORAL~RESERPINE~HALSEY~1MG~A~080457~003~~Approved Prior to Jan 1
, 1982~No~DISCN~HALSEY DRUG CO INC
RESERPINE~TABLET;ORAL~RESERPINE~HIKMA PHARMS LLC~0.1MG~A~080975~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTICALS LLC
RESERPINE~TABLET;ORAL~RESERPINE~HIKMA PHARMS LLC~0.25MG~A~080975~002~~Approved P
rior to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTICALS LLC
RESERPINE~TABLET;ORAL~RESERPINE~HIKMA PHARMS LLC~1MG~A~080975~003~~Approved Prio
r to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTICALS LLC
RESERPINE~TABLET;ORAL~RESERPINE~IMPAX LABS~0.1MG~N~009627~001~~Approved Prior to
RESERPINE~TABLET;ORAL~RESERPINE~IMPAX LABS~0.25MG~N~009627~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
RESERPINE~TABLET;ORAL~RESERPINE~IVAX SUB TEVA PHARMS~0.1MG~N~011185~001~~Approve
S USA
RESERPINE~TABLET;ORAL~RESERPINE~IVAX SUB TEVA PHARMS~0.25MG~N~011185~002~~Approv
LS USA
RESERPINE~TABLET;ORAL~RESERPINE~MARSHALL PHARMA~0.1MG~A~080492~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~MARSHALL PHARMACAL CORP
RESERPINE~TABLET;ORAL~RESERPINE~MARSHALL PHARMA~0.25MG~A~080492~002~~Approved Pr
ior to Jan 1, 1982~No~DISCN~MARSHALL PHARMACAL CORP
RESERPINE~TABLET;ORAL~RESERPINE~MK LABS~0.1MG~A~080525~002~~Approved Prior to Ja
RESERPINE~TABLET;ORAL~RESERPINE~MK LABS~0.25MG~A~080525~001~~Approved Prior to J
an 1, 1982~No~DISCN~MK LABORATORIES INC
RESERPINE~TABLET;ORAL~RESERPINE~MYLAN~1MG~A~084974~001~~Approved Prior to Jan 1,
RESERPINE~TABLET;ORAL~RESERPINE~PHARMAVITE~0.25MG~A~084663~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~PHARMAVITE PHARMACEUTICALS
RESERPINE~TABLET;ORAL~RESERPINE~PUREPAC PHARM~0.1MG~A~080753~002~~Approved Prior
RESERPINE~TABLET;ORAL~RESERPINE~PUREPAC PHARM~0.25MG~A~080753~001~~Approved Prio
RESERPINE~TABLET;ORAL~RESERPINE~PVT FORM~0.1MG~A~086117~001~~Approved Prior to J
an 1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
RESERPINE~TABLET;ORAL~RESERPINE~PVT FORM~0.25MG~A~080582~001~~Approved Prior to
RESERPINE~TABLET;ORAL~RESERPINE~PVT FORM~0.25MG~A~085775~001~~Approved Prior to
RESERPINE~TABLET;ORAL~RESERPINE~PVT FORM~1MG~A~080582~002~~Approved Prior to Jan
1, 1982~No~DISCN~PRIVATE FORMULATIONS INC
RESERPINE~TABLET;ORAL~RESERPINE~REXALL~0.25MG~A~080637~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~REXALL DRUG CO
RESERPINE~TABLET;ORAL~RESERPINE~SANDOZ~0.1MG~N~009838~001~BP~Approved Prior to J
an 1, 1982~No~RX~SANDOZ INC
RESERPINE~TABLET;ORAL~RESERPINE~SANDOZ~0.25MG~N~009838~002~BP~Approved Prior to
Jan 1, 1982~Yes~RX~SANDOZ INC
RESERPINE~TABLET;ORAL~RESERPINE~SOLVAY~0.25MG~A~080446~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
RESERPINE~TABLET;ORAL~RESERPINE~TABLICAPS~0.25MG~A~085207~001~~Approved Prior to
Jan 1, 1982~No~DISCN~TABLICAPS INC
RESERPINE~TABLET;ORAL~RESERPINE~TEVA~0.1MG~A~089020~001~~Mar 7, 1985~No~DISCN~TE
RESERPINE~TABLET;ORAL~RESERPINE~TEVA~0.25MG~A~089019~001~~Mar 7, 1985~No~DISCN~T
RESERPINE~TABLET;ORAL~RESERPINE~VALEANT PHARM INTL~0.1MG~N~009667~001~~Approved
RESERPINE~TABLET;ORAL~RESERPINE~VALEANT PHARM INTL~0.25MG~N~009667~002~~Approved

RESERPINE~TABLET;ORAL~RESERPINE~WATSON LABS~0.1MG~A~080679~001~~Approved Prior t
RESERPINE~TABLET;ORAL~RESERPINE~WATSON LABS~0.25MG~A~080393~001~~Approved Prior
RESERPINE~TABLET;ORAL~RESERPINE~WATSON LABS~0.25MG~A~085401~001~~Approved Prior
RESERPINE~TABLET;ORAL~RESERPINE~WATSON LABS~1MG~A~080749~001~~Approved Prior to
Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
RESERPINE~TABLET;ORAL~RESERPINE~WHITEWORTH TOWN PLSN~0.1MG~A~080723~001~~Approve
RESERPINE~TABLET;ORAL~RESERPINE~WHITEWORTH TOWN PLSN~0.25MG~A~080723~002~~Approv
ed Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
RESERPINE~TABLET;ORAL~RESERPINE~WHITEWORTH TOWN PLSN~1MG~A~080723~003~~Approved
Prior to Jan 1, 1982~No~DISCN~WHITEWORTH TOWNE PAULSEN INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~RESERPINE AND HYDROCHLOROTHIAZIDE~BAR
R~25MG;0.125MG~A~084580~001~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORAT
ORIES INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~RESERPINE AND HYDROCHLOROTHIAZIDE~BAR
R~50MG;0.125MG~A~084579~001~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORAT
ORIES INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~RESERPINE AND HYDROCHLOROTHIAZIDE~SAN
DOZ~50MG;0.125MG~A~088200~001~~Jan 31, 1984~No~DISCN~SANDOZ INC
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~RESERPINE AND HYDROCHLOROTHIAZIDE-50~
WEST WARD~50MG;0.125MG~A~088189~001~~May 10, 1984~No~DISCN~WEST WARD PHARMACEUTI
CAL CORP
HYDROFLUMETHIAZIDE; RESERPINE~TABLET;ORAL~RESERPINE AND HYDROFLUMETHIAZIDE~IVAX
PHARMS~50MG;0.125MG~A~088932~001~~Jan 11, 1985~No~DISCN~IVAX PHARMACEUTICALS INC
HYDROFLUMETHIAZIDE; RESERPINE~TABLET;ORAL~RESERPINE AND HYDROFLUMETHIAZIDE~PAR P
HARM~50MG;0.125MG~A~088907~001~~Sep 20, 1985~No~DISCN~PAR PHARMACEUTICAL INC
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~RESERPINE,
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE~MUTUAL PHARM~25MG;15MG;0.1MG~
A~088570~001~~Apr 10, 1984~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE~SOLVAY~25MG;15MG;0.1MG~A~0883
76~001~~Oct 28, 1983~No~DISCN~SOLVAY PHARMACEUTICALS
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~25MG;15MG;0.1MG~A
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE~WATSON LABS~25MG;15MG;0.1MG~A
HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE~LEDERLE~25MG;15MG;0.1MG~A~08
7709~001~~May 13, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
ZIDOVUDINE~TABLET;ORAL~RETROVIR~VIIV HLTHCARE~200MG~N~020518~001~~Dec 19, 1995~N
o~DISCN~VIIV HEALTHCARE CO
ZIDOVUDINE~TABLET;ORAL~RETROVIR~VIIV HLTHCARE~300MG~N~020518~002~~Oct 4, 1996~No
~DISCN~VIIV HEALTHCARE CO
SILDENAFIL CITRATE~TABLET;ORAL~REVATIO~PFIZER~EQ 20MG BASE~N~021845~001~AB~Jun 3
, 2005~Yes~RX~PFIZER INC
NALTREXONE HYDROCHLORIDE~TABLET;ORAL~REVIA~TEVA WOMENS~50MG~N~018932~001~AB~Nov
20, 1984~Yes~RX~TEVA WOMENS HEALTH INC
TROGLITAZONE~TABLET;ORAL~REZULIN~PFIZER PHARMS~200MG~N~020720~001~~Jan 29, 1997~
No~DISCN~PFIZER PHARMACEUTICALS LTD
TROGLITAZONE~TABLET;ORAL~REZULIN~PFIZER PHARMS~300MG~N~020720~003~~Aug 4, 1997~N
o~DISCN~PFIZER PHARMACEUTICALS LTD
TROGLITAZONE~TABLET;ORAL~REZULIN~PFIZER PHARMS~400MG~N~020720~002~~Jan 29, 1997~
No~DISCN~PFIZER PHARMACEUTICALS LTD
RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~AUROBINDO PHARMA~200MG~A~079111~001~AB~Sep 17, 2

RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~SANDOZ~200MG~A~077743~001~AB~Oct 3, 2006~No~RX~S
ANDOZ INC
RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~SANDOZ~200MG~A~202546~001~AB~Aug 12, 2014~No~RX~
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~TEVA~200MG~A~077053~001~AB~Dec 5, 2005~No~RX~TEV
RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~THREE RIVERS PHARMS~200MG~A~077456~001~AB~Dec 5,
2005~No~RX~THREE RIVERS PHARMACEUTICALS LLC
2005~No~RX~THREE RIVERS PHARMACEUTICALS LLC
2005~Yes~RX~THREE RIVERS PHARMACEUTICALS LLC
RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~ZYDUS PHARMS USA~200MG~A~077094~001~AB~Dec 5, 20
RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~ZYDUS PHARMS USA~400MG~A~077094~002~AB~Mar 16, 2
RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~ZYDUS PHARMS USA~500MG~A~077094~004~AB~Apr 18, 2
RIBAVIRIN~TABLET;ORAL~RIBAVIRIN~ZYDUS PHARMS USA~600MG~A~077094~003~AB~Mar 16, 2
ISONIAZID; PYRAZINAMIDE; RIFAMPIN~TABLET;ORAL~RIFATER~SANOFI AVENTIS US~50MG;300
MG;120MG~N~050705~001~~May 31, 1994~Yes~RX~SANOFI AVENTIS US LLC
RILUZOLE~TABLET;ORAL~RILUTEK~COVIS PHARMA SARL~50MG~N~020599~001~AB~Dec 12, 1995
~Yes~RX~COVIS PHARMA SARL
RILUZOLE~TABLET;ORAL~RILUZOLE~APOTEX CORP~50MG~A~091300~001~AB~Jun 18, 2013~No~R
X~APOTEX CORP
RILUZOLE~TABLET;ORAL~RILUZOLE~GLENMARK GENERICS~50MG~A~091394~001~AB~Jun 18, 201
RILUZOLE~TABLET;ORAL~RILUZOLE~IMPAX LABS~50MG~A~076173~001~AB~Jan 29, 2003~No~RX
RILUZOLE~TABLET;ORAL~RILUZOLE~MYLAN PHARMS INC~50MG~A~203042~001~AB~Jul 1, 2013~
RILUZOLE~TABLET;ORAL~RILUZOLE~SUN PHARM INDS LTD~50MG~A~091417~001~AB~Jun 18, 20
CARPROFEN~TABLET;ORAL~RIMADYL~ROCHE~100MG~N~018550~002~~Dec 31, 1987~No~DISCN~HO
FFMANN LA ROCHE INC
CARPROFEN~TABLET;ORAL~RIMADYL~ROCHE~150MG~N~018550~003~~Dec 31, 1987~No~DISCN~HO
FFMANN LA ROCHE INC
RIMANTADINE HYDROCHLORIDE~TABLET;ORAL~RIMANTADINE HYDROCHLORIDE~ACTAVIS ELIZABET
H~100MG~A~076375~001~~Jan 14, 2003~No~DISCN~ACTAVIS ELIZABETH LLC
RIMANTADINE HYDROCHLORIDE~TABLET;ORAL~RIMANTADINE HYDROCHLORIDE~COREPHARMA~100MG
~A~075916~001~~Nov 2, 2001~No~DISCN~COREPHARMA LLC
RIMANTADINE HYDROCHLORIDE~TABLET;ORAL~RIMANTADINE HYDROCHLORIDE~IMPAX LABS~100MG
~A~076132~001~AB~Aug 30, 2002~No~RX~IMPAX LABORATORIES INC
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~APOTEX INC~75MG~A~090877~002~A
B~Jun 10, 2014~No~RX~APOTEX INC
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~APOTEX INC~150MG~A~090877~003~
AB~Jun 10, 2014~No~RX~APOTEX INC
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~MYLAN PHARMS INC~75MG~A~200477
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~MYLAN PHARMS INC~150MG~A~20047
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~SUN PHARMA GLOBAL~75MG~A~09088
6~004~AB~Jun 10, 2014~No~RX~SUN PHARMA GLOBAL FZE

RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~SUN PHARMA GLOBAL~150MG~A~0908
86~005~AB~Jun 10, 2014~No~RX~SUN PHARMA GLOBAL FZE
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~TEVA PHARMS~5MG~A~077132~001~A
B~Oct 5, 2007~No~RX~TEVA PHARMACEUTICALS USA
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~TEVA PHARMS~30MG~A~077132~002~
AB~Oct 5, 2007~No~RX~TEVA PHARMACEUTICALS USA
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~TEVA PHARMS~35MG~A~077132~003~
AB~Oct 5, 2007~No~RX~TEVA PHARMACEUTICALS USA
RISEDRONATE SODIUM~TABLET;ORAL~RISEDRONATE SODIUM~TEVA PHARMS USA~150MG~A~079215
~001~AB~Jun 13, 2014~No~RX~TEVA PHARMACEUTICALS USA
RISPERIDONE~TABLET;ORAL~RISPERDAL~JANSSEN PHARMS~0.25MG~N~020272~008~AB~May 10,
RISPERIDONE~TABLET;ORAL~RISPERDAL~JANSSEN PHARMS~0.5MG~N~020272~007~AB~Jan 27, 1
RISPERIDONE~TABLET;ORAL~RISPERDAL~JANSSEN PHARMS~1MG~N~020272~001~AB~Dec 29, 199
RISPERIDONE~TABLET;ORAL~RISPERDAL~JANSSEN PHARMS~5MG~N~020272~005~~Dec 29, 1993~
No~DISCN~JANSSEN PHARMACEUTICALS INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~AJANTA PHARMA LTD~0.25MG~A~201003~001~AB~Aug
RISPERIDONE~TABLET;ORAL~RISPERIDONE~AJANTA PHARMA LTD~0.5MG~A~201003~002~AB~Aug
RISPERIDONE~TABLET;ORAL~RISPERIDONE~AJANTA PHARMA LTD~1MG~A~201003~003~AB~Aug 24
RISPERIDONE~TABLET;ORAL~RISPERIDONE~APOTEX INC~0.25MG~A~077953~001~AB~Sep 15, 20
08~No~RX~APOTEX INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~APOTEX INC~0.5MG~A~077953~002~AB~Sep 15, 200
8~No~RX~APOTEX INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~APOTEX INC~1MG~A~077953~003~AB~Sep 15, 2008~
No~RX~APOTEX INC
No~RX~APOTEX INC
No~RX~APOTEX INC
No~RX~APOTEX INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~AUROBINDO PHARMA~0.25MG~A~078269~001~AB~Oct
RISPERIDONE~TABLET;ORAL~RISPERIDONE~AUROBINDO PHARMA~0.5MG~A~078269~002~AB~Oct 8
RISPERIDONE~TABLET;ORAL~RISPERIDONE~AUROBINDO PHARMA~1MG~A~078269~003~AB~Oct 8,

RISPERIDONE~TABLET;ORAL~RISPERIDONE~CADISTA PHARMS~0.25MG~A~078828~001~~Mar 23,
2009~No~DISCN~CADISTA PHARMACEUTICALS INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~CADISTA PHARMS~0.5MG~A~078828~002~~Mar 23, 2
RISPERIDONE~TABLET;ORAL~RISPERIDONE~CADISTA PHARMS~1MG~A~078828~003~~Mar 23, 200
RISPERIDONE~TABLET;ORAL~RISPERIDONE~CIPLA~0.25MG~A~077543~001~AB~May 18, 2011~No
~RX~CIPLA LTD
RISPERIDONE~TABLET;ORAL~RISPERIDONE~CIPLA~0.5MG~A~077543~002~AB~May 18, 2011~No~
RX~CIPLA LTD
RISPERIDONE~TABLET;ORAL~RISPERIDONE~CIPLA~1MG~A~077543~003~AB~May 18, 2011~No~RX
~CIPLA LTD
~CIPLA LTD
~CIPLA LTD
~CIPLA LTD
RISPERIDONE~TABLET;ORAL~RISPERIDONE~DR REDDYS LABS LTD~0.25MG~A~076879~001~AB~Oc
t 24, 2008~No~RX~DR REDDYS LABORATORIES LTD
RISPERIDONE~TABLET;ORAL~RISPERIDONE~DR REDDYS LABS LTD~0.5MG~A~076879~002~AB~Oct
RISPERIDONE~TABLET;ORAL~RISPERIDONE~DR REDDYS LABS LTD~1MG~A~076879~003~AB~Oct 2
RISPERIDONE~TABLET;ORAL~RISPERIDONE~MYLAN~0.25MG~A~076288~001~AB~Sep 15, 2008~No
RISPERIDONE~TABLET;ORAL~RISPERIDONE~MYLAN~0.5MG~A~076288~002~AB~Sep 15, 2008~No~
RISPERIDONE~TABLET;ORAL~RISPERIDONE~MYLAN~1MG~A~076288~003~AB~Sep 15, 2008~No~RX
RISPERIDONE~TABLET;ORAL~RISPERIDONE~PLIVA HRVATSKA DOO~0.25MG~A~077769~001~AB~Oc
t 16, 2008~No~RX~PLIVA HRVATSKA DOO
RISPERIDONE~TABLET;ORAL~RISPERIDONE~PLIVA HRVATSKA DOO~0.5MG~A~077769~002~AB~Oct
RISPERIDONE~TABLET;ORAL~RISPERIDONE~PLIVA HRVATSKA DOO~1MG~A~077769~003~AB~Oct 1

RISPERIDONE~TABLET;ORAL~RISPERIDONE~PRINSTON INC~0.25MG~A~077493~001~AB~Nov 29,
RISPERIDONE~TABLET;ORAL~RISPERIDONE~PRINSTON INC~0.5MG~A~077493~002~AB~Nov 29, 2
RISPERIDONE~TABLET;ORAL~RISPERIDONE~PRINSTON INC~1MG~A~077493~003~AB~Nov 29, 201
RISPERIDONE~TABLET;ORAL~RISPERIDONE~PROSAM LABS~0.25MG~A~078071~001~AB~Jun 17, 2
009~No~RX~PROSAM LABS LLC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~PROSAM LABS~0.5MG~A~078071~002~AB~Jun 17, 20
RISPERIDONE~TABLET;ORAL~RISPERIDONE~PROSAM LABS~1MG~A~078071~003~AB~Jun 17, 2009
~No~RX~PROSAM LABS LLC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~RATIOPHARM~0.25MG~A~077784~001~~Jun 8, 2010~
No~DISCN~RATIOPHARM
RISPERIDONE~TABLET;ORAL~RISPERIDONE~RATIOPHARM~0.5MG~A~077784~002~~Jun 8, 2010~N
o~DISCN~RATIOPHARM
RISPERIDONE~TABLET;ORAL~RISPERIDONE~RATIOPHARM~1MG~A~077784~003~~Jun 8, 2010~No~
DISCN~RATIOPHARM
DISCN~RATIOPHARM
DISCN~RATIOPHARM
DISCN~RATIOPHARM
RISPERIDONE~TABLET;ORAL~RISPERIDONE~SANDOZ~0.25MG~A~078528~001~AB~Oct 16, 2009~N
o~RX~SANDOZ INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~SANDOZ~0.5MG~A~078528~002~AB~Oct 16, 2009~No
~RX~SANDOZ INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~SANDOZ~1MG~A~078528~003~AB~Oct 16, 2009~No~R
X~SANDOZ INC
X~SANDOZ INC
X~SANDOZ INC
X~SANDOZ INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~SUN PHARM INDS INC~0.25MG~A~078036~001~AB~Ma
RISPERIDONE~TABLET;ORAL~RISPERIDONE~SUN PHARM INDS INC~0.5MG~A~078036~002~AB~Mar
RISPERIDONE~TABLET;ORAL~RISPERIDONE~SUN PHARM INDS INC~1MG~A~078036~003~AB~Mar 1

RISPERIDONE~TABLET;ORAL~RISPERIDONE~SYNTHON PHARMS~0.25MG~A~078187~001~~Oct 22,
RISPERIDONE~TABLET;ORAL~RISPERIDONE~SYNTHON PHARMS~0.5MG~A~078187~002~~Oct 22, 2
RISPERIDONE~TABLET;ORAL~RISPERIDONE~SYNTHON PHARMS~1MG~A~078187~003~~Oct 22, 200
RISPERIDONE~TABLET;ORAL~RISPERIDONE~TEVA~0.25MG~A~076228~001~AB~Jun 30, 2008~No~
RISPERIDONE~TABLET;ORAL~RISPERIDONE~TEVA~0.5MG~A~076228~002~AB~Jun 30, 2008~No~R
RISPERIDONE~TABLET;ORAL~RISPERIDONE~TEVA~1MG~A~076228~003~AB~Jun 30, 2008~No~RX~
RISPERIDONE~TABLET;ORAL~RISPERIDONE~TORRENT PHARMS~0.25MG~A~079088~001~AB~Oct 30
RISPERIDONE~TABLET;ORAL~RISPERIDONE~TORRENT PHARMS~0.5MG~A~079088~002~AB~Oct 30,
RISPERIDONE~TABLET;ORAL~RISPERIDONE~TORRENT PHARMS~1MG~A~079088~003~AB~Oct 30, 2
RISPERIDONE~TABLET;ORAL~RISPERIDONE~VINTAGE~0.25MG~A~078707~001~AB~Dec 29, 2008~
No~RX~VINTAGE PHARMACEUTICALS LLC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~VINTAGE~0.5MG~A~078707~002~AB~Dec 29, 2008~N
o~RX~VINTAGE PHARMACEUTICALS LLC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~VINTAGE~1MG~A~078707~003~AB~Dec 29, 2008~No~
RISPERIDONE~TABLET;ORAL~RISPERIDONE~WATSON LABS~0.25MG~A~077860~001~~Dec 5, 2008
RISPERIDONE~TABLET;ORAL~RISPERIDONE~WATSON LABS~0.5MG~A~077860~002~~Dec 5, 2008~
RISPERIDONE~TABLET;ORAL~RISPERIDONE~WATSON LABS~1MG~A~077860~003~~Dec 5, 2008~No

RISPERIDONE~TABLET;ORAL~RISPERIDONE~WEST WARD PHARMS~0.25MG~A~078740~001~~May 29
, 2009~No~DISCN~WEST WARD PHARMACEUTICALS CORP
RISPERIDONE~TABLET;ORAL~RISPERIDONE~WEST WARD PHARMS~0.5MG~A~078740~002~~May 29,
2009~No~DISCN~WEST WARD PHARMACEUTICALS CORP
RISPERIDONE~TABLET;ORAL~RISPERIDONE~WEST WARD PHARMS~1MG~A~078740~003~~May 29, 2
RISPERIDONE~TABLET;ORAL~RISPERIDONE~WOCKHARDT~0.25MG~A~078871~001~AB~Oct 9, 2008
~No~RX~WOCKHARDT LTD
RISPERIDONE~TABLET;ORAL~RISPERIDONE~WOCKHARDT~0.5MG~A~078871~002~AB~Oct 9, 2008~
No~RX~WOCKHARDT LTD
RISPERIDONE~TABLET;ORAL~RISPERIDONE~WOCKHARDT~1MG~A~078871~003~AB~Oct 9, 2008~No
~RX~WOCKHARDT LTD
~RX~WOCKHARDT LTD
~RX~WOCKHARDT LTD
~RX~WOCKHARDT LTD
RISPERIDONE~TABLET;ORAL~RISPERIDONE~ZYDUS PHARMS USA INC~0.25MG~A~078040~001~AB~
Oct 16, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~ZYDUS PHARMS USA INC~0.5MG~A~078040~002~AB~O
ct 16, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
RISPERIDONE~TABLET;ORAL~RISPERIDONE~ZYDUS PHARMS USA INC~1MG~A~078040~003~AB~Oct
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~RITALIN~NOVARTIS~5MG~N~010187~003~AB~A
pproved Prior to Jan 1, 1982~No~RX~NOVARTIS PHARMACEUTICALS CORP
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~RITALIN~NOVARTIS~10MG~N~010187~006~AB~
Approved Prior to Jan 1, 1982~No~RX~NOVARTIS PHARMACEUTICALS CORP
METHYLPHENIDATE HYDROCHLORIDE~TABLET;ORAL~RITALIN~NOVARTIS~20MG~N~010187~010~AB~
Approved Prior to Jan 1, 1982~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
RITONAVIR~TABLET;ORAL~RITONAVIR~ROXANE~100MG~A~202573~001~AB~Jan 15, 2015~No~RX~
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~APOTEX INC~EQ 5MG BASE~A~2
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~APOTEX INC~EQ 10MG BASE~A~
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~AUROBINDO PHARMA LTD~EQ 5M
G BASE~A~202490~001~AB~Dec 31, 2012~No~RX~AUROBINDO PHARMA LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~AUROBINDO PHARMA LTD~EQ 10
MG BASE~A~202490~002~AB~Dec 31, 2012~No~RX~AUROBINDO PHARMA LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~CIPLA LTD~EQ 5MG BASE~A~07
7526~001~AB~Mar 26, 2013~No~RX~CIPLA LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~CIPLA LTD~EQ 10MG BASE~A~0
77526~002~AB~Mar 26, 2013~No~RX~CIPLA LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~EMCURE PHARMS LTD~EQ 5MG B
ASE~A~204090~001~AB~Nov 26, 2013~No~RX~EMCURE PHARMACEUTICALS LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~EMCURE PHARMS LTD~EQ 10MG
BASE~A~204090~002~AB~Nov 26, 2013~No~RX~EMCURE PHARMACEUTICALS LTD

RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~GLENMARK GENERICS~EQ 5MG B
ASE~A~201967~001~AB~Dec 31, 2012~No~RX~GLENMARK GENERICS LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~GLENMARK GENERICS~EQ 10MG
BASE~A~201967~002~AB~Dec 31, 2012~No~RX~GLENMARK GENERICS LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~INVAGEN PHARMS~EQ 5MG BASE
~A~204339~001~AB~Jul 1, 2013~No~RX~INVAGEN PHARMACEUTICALS INC
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~INVAGEN PHARMS~EQ 10MG BAS
E~A~204339~002~AB~Jul 1, 2013~No~RX~INVAGEN PHARMACEUTICALS INC
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~JUBILANT GENERICS~EQ 5MG B
ASE~A~203252~001~AB~Dec 31, 2014~No~RX~JUBILANT GENERICS LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~JUBILANT GENERICS~EQ 10MG
BASE~A~203252~002~AB~Dec 31, 2014~No~RX~JUBILANT GENERICS LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~MACLEODS PHARMS LTD~EQ 5MG
BASE~A~203147~001~AB~Feb 11, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~MACLEODS PHARMS LTD~EQ 10M
G BASE~A~203147~002~AB~Feb 11, 2014~No~RX~MACLEODS PHARMACEUTICALS LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~MYLAN PHARMS INC~EQ 5MG BA
SE~A~201993~001~AB~Dec 31, 2012~No~RX~MYLAN PHARMACEUTICALS INC
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~MYLAN PHARMS INC~EQ 10MG B
ASE~A~201993~002~AB~Dec 31, 2012~No~RX~MYLAN PHARMACEUTICALS INC
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~NATCO PHARMA LTD~EQ 5MG BA
SE~A~200482~001~AB~Dec 31, 2012~No~RX~NATCO PHARMA LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~NATCO PHARMA LTD~EQ 10MG B
ASE~A~200482~002~AB~Dec 31, 2012~No~RX~NATCO PHARMA LTD
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~SANDOZ~EQ 5MG BASE~A~07923
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~SANDOZ~EQ 10MG BASE~A~0792
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~SUN PHARMA GLOBAL~EQ 5MG B
ASE~A~202047~001~AB~Dec 31, 2012~No~RX~SUN PHARMA GLOBAL FZE
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~SUN PHARMA GLOBAL~EQ 10MG
BASE~A~202047~002~AB~Dec 31, 2012~No~RX~SUN PHARMA GLOBAL FZE
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~TEVA PHARMS~EQ 5MG BASE~A~
077263~001~AB~Dec 31, 2012~No~RX~TEVA PHARMACEUTICALS USA
RIZATRIPTAN BENZOATE~TABLET;ORAL~RIZATRIPTAN BENZOATE~TEVA PHARMS~EQ 10MG BASE~A
~077263~002~AB~Dec 31, 2012~No~RX~TEVA PHARMACEUTICALS USA
METHOCARBAMOL~TABLET;ORAL~ROBAXIN~AUXILIUM PHARMS LLC~500MG~N~011011~004~AA~Appr
oved Prior to Jan 1, 1982~Yes~RX~AUXILIUM PHARMACEUTICALS LLC
METHOCARBAMOL~TABLET;ORAL~ROBAXIN-750~AUXILIUM PHARMS LLC~750MG~N~011011~006~AA~
Approved Prior to Jan 1, 1982~Yes~RX~AUXILIUM PHARMACEUTICALS LLC
ASPIRIN; METHOCARBAMOL~TABLET;ORAL~ROBAXISAL~ROBINS AH~325MG;400MG~N~012281~001~
~Approved Prior to Jan 1, 1982~No~DISCN~AH ROBINS CO
GLYCOPYRROLATE~TABLET;ORAL~ROBINUL~SHIONOGI INC~1MG~N~012827~001~AA~Approved Pri
or to Jan 1, 1982~Yes~RX~SHIONOGI INC
GLYCOPYRROLATE~TABLET;ORAL~ROBINUL FORTE~SHIONOGI INC~2MG~N~012827~002~AA~Approv
ed Prior to Jan 1, 1982~Yes~RX~SHIONOGI INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~ALEMBIC LTD~EQ 0.2
5MG BASE~A~090429~001~AB~Mar 24, 2010~No~RX~ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~ALEMBIC LTD~EQ 0.5
MG BASE~A~090429~002~AB~Mar 24, 2010~No~RX~ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~ALEMBIC LTD~EQ 1MG
BASE~A~090429~003~AB~Mar 24, 2010~No~RX~ALEMBIC LTD

ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~APOTEX~EQ 0.25MG B
ASE~A~079165~001~AB~Feb 7, 2012~No~RX~APOTEX INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~APOTEX~EQ 0.5MG BA
SE~A~079165~002~AB~Feb 7, 2012~No~RX~APOTEX INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~APOTEX~EQ 1MG BASE
~A~079165~003~AB~Feb 7, 2012~No~RX~APOTEX INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~COREPHARMA~EQ 0.25
MG BASE~A~078230~001~~May 20, 2008~No~DISCN~COREPHARMA LLC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~COREPHARMA~EQ 0.5M
G BASE~A~078230~002~~May 20, 2008~No~DISCN~COREPHARMA LLC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~COREPHARMA~EQ 1MG
BASE~A~078230~003~~May 20, 2008~No~DISCN~COREPHARMA LLC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~GLENMARK GENERICS~
EQ 0.25MG BASE~A~090135~001~AB~Feb 25, 2010~No~RX~GLENMARK GENERICS LTD
EQ 0.5MG BASE~A~090135~002~AB~Feb 25, 2010~No~RX~GLENMARK GENERICS LTD
EQ 1MG BASE~A~090135~003~AB~Feb 25, 2010~No~RX~GLENMARK GENERICS LTD
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~MYLAN~EQ 0.25MG BA
SE~A~078881~001~AB~May 5, 2008~No~RX~MYLAN PHARMACEUTICALS INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~MYLAN~EQ 0.5MG BAS
E~A~078881~002~AB~May 5, 2008~No~RX~MYLAN PHARMACEUTICALS INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~MYLAN~EQ 1MG BASE~
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~ORCHID HLTHCARE~EQ
0.25MG BASE~A~079229~001~AB~Nov 28, 2012~No~RX~ORCHID HEALTHCARE
0.5MG BASE~A~079229~002~AB~Nov 28, 2012~No~RX~ORCHID HEALTHCARE

1MG BASE~A~079229~003~AB~Nov 28, 2012~No~RX~ORCHID HEALTHCARE
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~PRINSTON INC~EQ 0.
25MG BASE~A~078110~001~AB~May 5, 2008~No~RX~PRINSTON PHARMACEUTICAL INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~PRINSTON INC~EQ 0.
5MG BASE~A~078110~002~AB~May 5, 2008~No~RX~PRINSTON PHARMACEUTICAL INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~PRINSTON INC~EQ 1M
G BASE~A~078110~003~AB~May 5, 2008~No~RX~PRINSTON PHARMACEUTICAL INC
G BASE~A~078110~007~AB~Jul 11, 2008~No~RX~PRINSTON PHARMACEUTICAL INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~ROXANE~EQ 0.25MG B
ASE~A~077852~001~AB~May 5, 2008~No~RX~ROXANE LABORATORIES INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~ROXANE~EQ 0.5MG BA
SE~A~077852~002~AB~May 5, 2008~No~RX~ROXANE LABORATORIES INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~ROXANE~EQ 1MG BASE
~A~077852~003~AB~May 5, 2008~No~RX~ROXANE LABORATORIES INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~TEVA~EQ 0.25MG BAS
E~A~077460~001~AB~May 5, 2008~No~RX~TEVA PHARMACEUTICALS USA INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~TEVA~EQ 0.5MG BASE
~A~077460~002~AB~May 5, 2008~No~RX~TEVA PHARMACEUTICALS USA INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~TEVA~EQ 1MG BASE~A
~077460~003~AB~May 5, 2008~No~RX~TEVA PHARMACEUTICALS USA INC
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~WOCKHARDT~EQ 0.25M
G BASE~A~079050~001~AB~May 29, 2008~No~RX~WOCKHARDT LTD
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~WOCKHARDT~EQ 0.5MG
BASE~A~079050~002~AB~May 29, 2008~No~RX~WOCKHARDT LTD
ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~WOCKHARDT~EQ 1MG B
ASE~A~079050~003~AB~May 29, 2008~No~RX~WOCKHARDT LTD

ROPINIROLE HYDROCHLORIDE~TABLET;ORAL~ROPINIROLE HYDROCHLORIDE~ZYDUS PHARMS USA I
NC~EQ 0.25MG BASE~A~090411~001~AB~Jun 1, 2009~No~RX~ZYDUS PHARMACEUTICALS USA IN
C
NC~EQ 0.5MG BASE~A~090411~002~AB~Jun 1, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
NC~EQ 1MG BASE~A~090411~003~AB~Jun 1, 2009~No~RX~ZYDUS PHARMACEUTICALS USA INC
ROSIGLITAZONE MALEATE~TABLET;ORAL~ROSIGLITAZONE MALEATE~TEVA~EQ 2MG BASE~A~07674
7~001~AB~Jan 25, 2013~No~RX~TEVA PHARMACEUTICALS USA INC
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE~TABLET;ORAL~ROSIGLITAZONE MALEATE
AND METFORMIN HYDROCHLORIDE~TEVA~1GM;EQ 4MG BASE~A~077337~004~AB~May 7, 2014~No
AND METFORMIN HYDROCHLORIDE~TEVA~1GM;EQ 2MG BASE~A~077337~003~AB~May 7, 2014~No
AND METFORMIN HYDROCHLORIDE~TEVA~500MG;EQ 2MG BASE~A~077337~001~AB~May 7, 2014~
AND METFORMIN HYDROCHLORIDE~TEVA~500MG;EQ 4MG BASE~A~077337~002~AB~May 7, 2014~
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~ROXICET~ROXANE~325MG;5MG~A~08
7003~001~AA~Approved Prior to Jan 1, 1982~No~RX~ROXANE LABORATORIES INC
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE~TABLET;ORAL~ROXICET 5/500~ROXANE~500MG;5M
G~A~089775~001~~Jan 12, 1989~No~DISCN~ROXANE LABORATORIES INC
OXYCODONE HYDROCHLORIDE~TABLET;ORAL~ROXICODONE~MALLINCKRODT INC~5MG~N~021011~003
~AB~May 15, 2009~No~RX~MALLINCKRODT INC
1~AB~Aug 31, 2000~Yes~RX~MALLINCKRODT INC
2~AB~Aug 31, 2000~No~RX~MALLINCKRODT INC
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE~TABLET;ORAL~ROXIPRIN~R
OXANE~325MG;4.5MG;0.38MG~A~087743~001~~Jun 4, 1982~No~DISCN~ROXANE LABORATORIES
INC
RAMELTEON~TABLET;ORAL~ROZEREM~TAKEDA PHARMS USA~8MG~N~021782~001~AB~Jul 22, 2005
~Yes~RX~TAKEDA PHARMACEUTICALS USA INC
IBUPROFEN~TABLET;ORAL~RUFEN~BASF~600MG~N~018197~002~~Mar 5, 1984~No~DISCN~BASF C
ORP
PROPAFENONE HYDROCHLORIDE~TABLET;ORAL~RYTHMOL~GLAXOSMITHKLINE LLC~150MG~N~019151
~001~AB~Nov 27, 1989~No~RX~GLAXOSMITHKLINE LLC
~003~AB~Nov 20, 1992~No~RX~GLAXOSMITHKLINE LLC

~002~AB~Nov 27, 1989~Yes~RX~GLAXOSMITHKLINE LLC
SULFASALAZINE~TABLET;ORAL~S.A.S.-500~SOLVAY~500MG~A~083450~001~~Approved Prior t
VIGABATRIN~TABLET;ORAL~SABRIL~LUNDBECK LLC~500MG~N~020427~001~~Aug 21, 2009~Yes~
RX~LUNDBECK LLC
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM~TABLET;ORAL~SAFYRAL~BAYER
HLTHCARE~3MG,N/A;0.03MG,N/A;0.451MG,0.451MG~N~022574~001~~Dec 16, 2010~Yes~RX~BA
YER HEALTHCARE PHARMACEUTICALS INC
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~SALAGEN~EISAI INC~5MG~N~020237~001~AB~Mar
22, 1994~No~RX~EISAI INC
PILOCARPINE HYDROCHLORIDE~TABLET;ORAL~SALAGEN~EISAI INC~7.5MG~N~020237~002~AB~Ap
r 18, 2003~Yes~RX~EISAI INC
HYDROFLUMETHIAZIDE~TABLET;ORAL~SALURON~SHIRE LLC~50MG~N~011949~001~AB~Approved P
rior to Jan 1, 1982~Yes~RX~SHIRE DEVELOPMENT LLC
HYDROFLUMETHIAZIDE; RESERPINE~TABLET;ORAL~SALUTENSIN~SHIRE~50MG;0.125MG~N~012359
~003~~Approved Prior to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
HYDROFLUMETHIAZIDE; RESERPINE~TABLET;ORAL~SALUTENSIN-DEMI~SHIRE~25MG;0.125MG~N~0
12359~004~~Approved Prior to Jan 1, 1982~No~DISCN~SHIRE DEVELOPMENT INC
TOLVAPTAN~TABLET;ORAL~SAMSCA~OTSUKA AMERICA PHARM~15MG~N~022275~001~~May 19, 200
9~No~RX~OTSUKA AMERICA PHARMACEUTICAL INC
9~Yes~RX~OTSUKA AMERICA PHARMACEUTICAL INC
9~No~DISCN~OTSUKA AMERICA PHARMACEUTICAL INC
TROSPIUM CHLORIDE~TABLET;ORAL~SANCTURA~ALLERGAN~20MG~N~021595~001~AB~May 28, 200
RESERPINE~TABLET;ORAL~SANDRIL~LILLY~0.1MG~N~009376~004~~Approved Prior to Jan 1,
RESERPINE~TABLET;ORAL~SANDRIL~LILLY~0.25MG~N~009376~001~~Approved Prior to Jan 1
MAZINDOL~TABLET;ORAL~SANOREX~NOVARTIS~1MG **Federal Register determination that
MAZINDOL~TABLET;ORAL~SANOREX~NOVARTIS~2MG **Federal Register determination that
METHYSERGIDE MALEATE~TABLET;ORAL~SANSERT~NOVARTIS~2MG~N~012516~001~~Approved Pri
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~SARAFEM~WARNER CHILCOTT LLC~EQ 10MG BASE~N~
021860~001~AB1~May 19, 2006~No~RX~WARNER CHILCOTT CO LLC
021860~002~AB1~May 19, 2006~No~RX~WARNER CHILCOTT CO LLC
021860~003~AB1~May 19, 2006~Yes~RX~WARNER CHILCOTT CO LLC
BUTABARBITAL SODIUM~TABLET;ORAL~SARISOL NO. 1~HALSEY~15MG~A~084719~001~~Approved
BUTABARBITAL SODIUM~TABLET;ORAL~SARISOL NO. 2~HALSEY~30MG~A~084719~002~~Approved
METRONIDAZOLE~TABLET;ORAL~SATRIC~SAVAGE LABS~250MG~A~070029~001~~Mar 19, 1985~No
~DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
METRONIDAZOLE~TABLET;ORAL~SATRIC~SAVAGE LABS~500MG~A~070731~001~~Jun 8, 1987~No~
DISCN~SAVAGE LABORATORIES INC DIV ALTANA INC
EDOXABAN TOSYLATE~TABLET;ORAL~SAVAYSA~DAIICHI SANKYO~EQ 15MG BASE~N~206316~001~~
Jan 8, 2015~No~RX~DAIICHI SANKYO INC
Jan 8, 2015~No~RX~DAIICHI SANKYO INC
Jan 8, 2015~Yes~RX~DAIICHI SANKYO INC
MILNACIPRAN HYDROCHLORIDE~TABLET;ORAL~SAVELLA~CYPRESS BIOSCIENCE~12.5MG~N~022256

~001~~Jan 14, 2009~No~RX~CYPRESS BIOSCIENCE INC
MILNACIPRAN HYDROCHLORIDE~TABLET;ORAL~SAVELLA~CYPRESS BIOSCIENCE~25MG~N~022256~0
02~~Jan 14, 2009~No~RX~CYPRESS BIOSCIENCE INC
MILNACIPRAN HYDROCHLORIDE~TABLET;ORAL~SAVELLA~CYPRESS BIOSCIENCE~50MG~N~022256~0
03~~Jan 14, 2009~Yes~RX~CYPRESS BIOSCIENCE INC
MILNACIPRAN HYDROCHLORIDE~TABLET;ORAL~SAVELLA~CYPRESS BIOSCIENCE~100MG~N~022256~
004~~Jan 14, 2009~No~RX~CYPRESS BIOSCIENCE INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~SEASONALE~TEVA BRANDED PHARM~0.03M
G;0.15MG~N~021544~001~AB~Sep 5, 2003~Yes~RX~TEVA BRANDED PHARMACEUTICAL PRODUCTS
R AND D INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~SEASONIQUE~TEVA BRANDED PHARM~0.03
MG,0.01MG;0.15MG,N/A~N~021840~001~AB~May 25, 2006~Yes~RX~TEVA BRANDED PHARMACEUT
ICAL PRODUCTS R AND D INC
ACETAMINOPHEN; BUTALBITAL~TABLET;ORAL~SEDAPAP~MAYRAND~650MG;50MG~A~088944~001~~O
ct 17, 1985~No~DISCN~MAYRAND INC
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~APOTEX INC~5MG~A~0
74871~001~AB~Jun 6, 1997~Yes~RX~APOTEX INC ETOBICOKE SITE
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~DAVA PHARMS INC~5M
G~A~074641~001~~Aug 2, 1996~No~DISCN~DAVA PHARMACEUTICALS INC
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~5MG~A~074756~001~~Nov 25, 1998~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHA
RMACEUTICALS USA
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~MYLAN~5MG~A~074866
~001~AB~Nov 26, 1997~No~RX~MYLAN PHARMACEUTICALS INC
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~SIEGFRIED~5MG~A~07
4672~001~~Apr 1, 1997~No~DISCN~SIEGFRIED LTD
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~SOMERSET~5MG~N~019
334~001~~Jun 5, 1989~No~DISCN~SOMERSET PHARMACEUTICALS INC
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~STASON~5MG~A~07491
2~001~AB~Apr 30, 1998~No~RX~STASON INDUSTRIAL CORP
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~TEVA~5MG~A~074537~
001~~Aug 2, 1996~No~DISCN~TEVA PHARMACEUTICALS USA INC
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~TEVA~5MG~A~074744~
001~~Jan 27, 1997~No~DISCN~TEVA PHARMACEUTICALS USA INC
SELEGILINE HYDROCHLORIDE~TABLET;ORAL~SELEGILINE HYDROCHLORIDE~VINTAGE PHARMS LLC
~5MG~A~074565~001~~Aug 2, 1996~No~DISCN~VINTAGE PHARMACEUTICALS LLC
FLUOXETINE HYDROCHLORIDE~TABLET;ORAL~SELFEMRA~TEVA PHARMS USA~EQ 10MG BASE~A~200
151~001~AB1~Feb 3, 2014~No~RX~TEVA PHARMACEUTICALS USA INC
MARAVIROC~TABLET;ORAL~SELZENTRY~VIIV HLTHCARE~150MG~N~022128~001~~Aug 6, 2007~No
~RX~VIIV HEALTHCARE CO
MARAVIROC~TABLET;ORAL~SELZENTRY~VIIV HLTHCARE~300MG~N~022128~002~~Aug 6, 2007~Ye
s~RX~VIIV HEALTHCARE CO
CINACALCET HYDROCHLORIDE~TABLET;ORAL~SENSIPAR~AMGEN~EQ 30MG BASE~N~021688~001~~M
ar 8, 2004~No~RX~AMGEN INC
ar 8, 2004~No~RX~AMGEN INC
ar 8, 2004~Yes~RX~AMGEN INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SEPTRA~MONARCH PHARMS~400MG;80MG~N~01
7376~001~AB~Approved Prior to Jan 1, 1982~No~RX~MONARCH PHARMACEUTICALS INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SEPTRA DS~MONARCH PHARMS~800MG;160MG~
N~017376~002~AB~Approved Prior to Jan 1, 1982~No~RX~MONARCH PHARMACEUTICALS INC
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~SER-A-GEN~
SOLVAY~25MG;15MG;0.1MG~A~087210~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLV
AY PHARMACEUTICALS
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~SER-AP-ES~

NOVARTIS~25MG;15MG;0.1MG~N~012193~005~~Approved Prior to Jan 1, 1982~No~DISCN~NO
OXAZEPAM~TABLET;ORAL~SERAX~ALPHARMA US PHARMS~15MG~N~015539~008~~Approved Prior
MESORIDAZINE BESYLATE~TABLET;ORAL~SERENTIL~NOVARTIS~EQ 10MG BASE~N~016774~001~~A
MESORIDAZINE BESYLATE~TABLET;ORAL~SERENTIL~NOVARTIS~EQ 100MG BASE~N~016774~004~~
CLOMIPHENE CITRATE~TABLET;ORAL~SEROPHENE~EMD SERONO~50MG~N~018361~001~AB~Mar 22,
1982~No~RX~EMD SERONO INC
QUETIAPINE FUMARATE~TABLET;ORAL~SEROQUEL~ASTRAZENECA~EQ 25MG BASE~N~020639~001~A
B~Sep 26, 1997~Yes~RX~ASTRAZENECA LP
QUETIAPINE FUMARATE~TABLET;ORAL~SEROQUEL~ASTRAZENECA~EQ 50MG BASE~N~020639~007~A
B~Oct 4, 2005~No~RX~ASTRAZENECA LP
QUETIAPINE FUMARATE~TABLET;ORAL~SEROQUEL~ASTRAZENECA~EQ 100MG BASE~N~020639~002~
AB~Sep 26, 1997~No~RX~ASTRAZENECA LP
~Dec 20, 1998~No~DISCN~ASTRAZENECA LP
AB~Sep 26, 1997~No~RX~ASTRAZENECA LP
AB~Jul 26, 2000~Yes~RX~ASTRAZENECA LP
AB~Oct 4, 2005~No~RX~ASTRAZENECA LP
RESERPINE~TABLET;ORAL~SERPALAN~LANNETT~0.1MG~N~010124~001~~Approved Prior to Jan
RESERPINE~TABLET;ORAL~SERPALAN~LANNETT~0.25MG~N~010124~002~~Approved Prior to Ja
RESERPINE~TABLET;ORAL~SERPANRAY~PANRAY~0.1MG~N~009391~001~~Approved Prior to Jan
RESERPINE~TABLET;ORAL~SERPANRAY~PANRAY~0.25MG~N~009391~002~~Approved Prior to Ja
n 1, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
RESERPINE~TABLET;ORAL~SERPANRAY~PANRAY~1MG~N~009391~004~~Approved Prior to Jan 1
, 1982~No~DISCN~PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
RESERPINE~TABLET;ORAL~SERPASIL~NOVARTIS~0.1MG~N~009115~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
RESERPINE~TABLET;ORAL~SERPASIL~NOVARTIS~0.25MG~N~009115~003~~Approved Prior to J
an 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
RESERPINE~TABLET;ORAL~SERPASIL~NOVARTIS~1MG~N~009115~004~~Approved Prior to Jan
HYDRALAZINE HYDROCHLORIDE; RESERPINE~TABLET;ORAL~SERPASIL-APRESOLINE~NOVARTIS~25
MG;0.1MG~N~009296~004~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEU
TICALS CORP
HYDRALAZINE HYDROCHLORIDE; RESERPINE~TABLET;ORAL~SERPASIL-APRESOLINE~NOVARTIS~50
MG;0.2MG~N~009296~002~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEU
TICALS CORP
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~SERPASIL-ESIDRIX #1~NOVARTIS~25MG;0.1
MG~N~011878~003~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS
CORP
HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~SERPASIL-ESIDRIX #2~NOVARTIS~50MG;0.1
MG~N~011878~005~~Approved Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS
CORP
RESERPINE~TABLET;ORAL~SERPATE~VALE~0.1MG~N~009453~001~~Approved Prior to Jan 1,
1982~No~DISCN~VALE CHEMICAL CO INC
RESERPINE~TABLET;ORAL~SERPATE~VALE~0.25MG~N~009453~002~~Approved Prior to Jan 1,
1982~No~DISCN~VALE CHEMICAL CO INC

RESERPINE~TABLET;ORAL~SERPIVITE~VITARINE~0.25MG~N~009645~002~~Approved Prior to
Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~ACCORD HLTHCARE~EQ
25MG BASE~A~202825~001~AB~Nov 7, 2014~No~RX~ACCORD HEALTHCARE INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~ACTAVIS ELIZABETH~
EQ 25MG BASE~A~077345~001~~Feb 6, 2007~No~DISCN~ACTAVIS ELIZABETH LLC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~APOTEX INC~EQ 25MG
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~APOTEX INC~EQ 50MG
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~APOTEX INC~EQ 100M
G BASE~A~076882~003~AB~Feb 6, 2007~No~RX~APOTEX INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~AUROBINDO PHARMA~E
Q 25MG BASE~A~077206~001~AB~Feb 6, 2007~No~RX~AUROBINDO PHARMA LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~AUSTARPHARMA LLC~E
Q 25MG BASE~A~078677~001~AB~Mar 4, 2009~No~RX~AUSTARPHARMA LLC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~CIPLA LTD~EQ 25MG
BASE~A~077162~001~~Feb 6, 2007~No~DISCN~CIPLA LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~DR REDDYS LABS LTD
~EQ 25MG BASE~A~076442~001~~Apr 30, 2007~No~DISCN~DR REDDYS LABORATORIES LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~HIKMA PHARMS~EQ 25
MG BASE~A~077864~001~AB~Aug 10, 2009~No~RX~HIKMA PHARMACEUTICALS
MG BASE~A~077864~002~AB~Aug 10, 2009~No~RX~HIKMA PHARMACEUTICALS
0MG BASE~A~077864~003~AB~Aug 10, 2009~No~RX~HIKMA PHARMACEUTICALS
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~INVAGEN PHARMS~EQ
25MG BASE~A~077397~001~AB~Feb 6, 2007~No~RX~INVAGEN PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~EQ 25MG BASE~A~075719~003~~Jun 30, 2006~No~DISCN~IVAX PHARMACEUTICALS INC SUB

MS~EQ 50MG BASE~A~075719~001~~Jun 30, 2006~No~DISCN~IVAX PHARMACEUTICALS INC SUB
MS~EQ 100MG BASE~A~075719~002~~Jun 30, 2006~No~DISCN~IVAX PHARMACEUTICALS INC SU
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~LUPIN~EQ 25MG BASE
~A~077670~001~AB~Feb 6, 2007~No~RX~LUPIN LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~LUPIN~EQ 50MG BASE
~A~077670~002~AB~Feb 6, 2007~No~RX~LUPIN LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~LUPIN~EQ 100MG BAS
E~A~077670~003~AB~Feb 6, 2007~No~RX~LUPIN LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~MUTUAL PHARM~EQ 25
MG BASE~A~077818~001~~Feb 6, 2007~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
MG BASE~A~077818~002~~Feb 6, 2007~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
0MG BASE~A~077818~003~~Feb 6, 2007~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~MYLAN~EQ 25MG BASE
~A~076671~001~AB~Feb 6, 2007~No~RX~MYLAN PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~MYLAN~EQ 50MG BASE
~A~076671~002~AB~Feb 6, 2007~No~RX~MYLAN PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~MYLAN~EQ 100MG BAS
E~A~076671~003~AB~Feb 6, 2007~No~RX~MYLAN PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~MYLAN PHARMS INC~E
Q 25MG BASE~A~076540~001~~Mar 20, 2007~No~DISCN~MYLAN PHARMACEUTICALS INC
Q 25MG BASE~A~078626~001~AB~Jan 31, 2008~No~RX~MYLAN PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~PLIVA HRVATSKA DOO
~EQ 25MG BASE~A~077299~001~~Feb 6, 2007~No~DISCN~PLIVA HRVATSKA DOO
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~PROSAM LABS~EQ 25M
G BASE~A~078175~001~AB~Jul 21, 2010~No~RX~PROSAM LABS LLC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~PROSAM LABS~EQ 50M
G BASE~A~078175~002~AB~Jul 21, 2010~No~RX~PROSAM LABS LLC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~PROSAM LABS~EQ 100
MG BASE~A~078175~003~AB~Jul 21, 2010~No~RX~PROSAM LABS LLC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~RANBAXY~EQ 25MG BA
SE~A~077977~001~AB~Feb 6, 2007~No~RX~RANBAXY LABORATORIES LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~RANBAXY~EQ 50MG BA
SE~A~077977~002~AB~Feb 6, 2007~No~RX~RANBAXY LABORATORIES LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~RANBAXY~EQ 100MG B
ASE~A~077977~003~AB~Feb 6, 2007~No~RX~RANBAXY LABORATORIES LTD
ASE~A~077977~004~~Feb 6, 2007~No~RX~RANBAXY LABORATORIES LTD
ASE~A~077977~005~~Feb 6, 2007~No~RX~RANBAXY LABORATORIES LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~ROXANE~EQ 25MG BAS
E~A~076881~001~~Feb 6, 2007~No~DISCN~ROXANE LABORATORIES INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~ROXANE~EQ 50MG BAS

E~A~076881~002~~Feb 6, 2007~No~DISCN~ROXANE LABORATORIES INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~ROXANE~EQ 100MG BA
SE~A~076881~003~~Feb 6, 2007~No~DISCN~ROXANE LABORATORIES INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~SANDOZ~EQ 25MG BAS
E~A~077713~001~~Feb 6, 2007~No~DISCN~SANDOZ INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~SANDOZ~EQ 50MG BAS
E~A~077713~002~~Feb 6, 2007~No~DISCN~SANDOZ INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~SANDOZ~EQ 100MG BA
SE~A~077713~003~~Feb 6, 2007~No~DISCN~SANDOZ INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~SUN PHARM INDS (IN
)~EQ 25MG BASE~A~078108~001~AB~Feb 6, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES L
TD
)~EQ 50MG BASE~A~078108~002~AB~Feb 6, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES L
TD
)~EQ 100MG BASE~A~078108~003~AB~Feb 6, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES
LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~TEVA~EQ 25MG BASE~
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~TEVA~EQ 50MG BASE~
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~TEVA~EQ 100MG BASE
~A~076465~003~AB~Aug 11, 2006~No~RX~TEVA PHARMACEUTICALS USA INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~TORRENT PHARMS~EQ
25MG BASE~A~077765~001~AB~Feb 6, 2007~No~RX~TORRENT PHARMACEUTICALS LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~WATSON LABS~EQ 25M
G BASE~A~077663~001~~Feb 6, 2007~No~DISCN~WATSON LABORATORIES INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~WATSON LABS~EQ 50M
G BASE~A~077663~002~~Feb 6, 2007~No~DISCN~WATSON LABORATORIES INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~WATSON LABS~EQ 100
MG BASE~A~077663~003~~Feb 6, 2007~No~DISCN~WATSON LABORATORIES INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~WOCKHARDT~EQ 25MG
BASE~A~078403~001~AB~Jan 8, 2008~No~RX~WOCKHARDT LTD
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~SERTRALINE HYDROCHLORIDE~ZYDUS PHARMS USA~E
Q 25MG BASE~A~077106~001~AB~Feb 6, 2007~No~RX~ZYDUS PHARMACEUTICALS USA INC
PREDNISONE~TABLET;ORAL~SERVISONE~LEDERLE~5MG~A~080223~001~~Approved Prior to Jan
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~SERZONE~BRISTOL MYERS SQUIBB~50MG~N~020152~
001~~Dec 22, 1994~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTI
TUTE
NEFAZODONE HYDROCHLORIDE~TABLET;ORAL~SERZONE~BRISTOL MYERS SQUIBB~100MG~N~020152
~002~~Dec 22, 1994~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INST
ITUTE
ITUTE

ITUTE
ITUTE
ITUTE
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL~SETLAKIN~NOVAST LABS LTD~0.03MG;0.
15MG~A~090716~001~AB~Sep 15, 2014~No~RX~NOVAST LABORATORIES LTD
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~ACTAVIS GRP PTC~EQ 20MG BASE~A
~200149~001~AB~Feb 25, 2013~No~RX~ACTAVIS GROUP PTC EHF
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~AMNEAL PHARMS~EQ 20MG BASE~A~2
02025~001~AB~Feb 28, 2013~No~RX~AMNEAL PHARMACEUTICALS
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~APOTEX CORP~EQ 20MG BASE~A~091
379~001~AB~Nov 6, 2012~No~RX~APOTEX CORP
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~DR REDDYS LABS LTD~EQ 20MG BAS
E~A~202598~001~AB~Nov 6, 2012~No~RX~DR REDDYS LABORATORIES LTD
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~HETERO LABS LTD V~EQ 20MG BASE
~A~203623~001~AB~Nov 26, 2014~No~RX~HETERO LABS LTD UNIT V
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~MACLEODS PHARMS LTD~EQ 20MG BA
SE~A~203814~001~AB~Dec 17, 2013~No~RX~MACLEODS PHARMACEUTICALS LTD
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~MYLAN PHARMS INC~EQ 20MG BASE~
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~TEVA PHARMS~EQ 20MG BASE~A~078
380~001~AB~Jan 7, 2013~No~RX~TEVA PHARMACEUTICALS USA
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~TORRENT PHARMS LTD~EQ 20MG BAS
E~A~091479~001~AB~Nov 6, 2012~No~RX~TORRENT PHARMACEUTICALS LTD
SILDENAFIL CITRATE~TABLET;ORAL~SILDENAFIL CITRATE~WATSON LABS INC~EQ 20MG BASE~A
~202503~001~AB~Nov 6, 2012~No~RX~WATSON LABORATORIES INC
DOXEPIN HYDROCHLORIDE~TABLET;ORAL~SILENOR~PERNIX THERAPS LLC~EQ 3MG BASE~N~02203
6~001~AB~Mar 17, 2010~No~RX~PERNIX THERAPEUTICS LLC
DOXEPIN HYDROCHLORIDE~TABLET;ORAL~SILENOR~PERNIX THERAPS LLC~EQ 6MG BASE~N~02203
6~002~AB~Mar 17, 2010~Yes~RX~PERNIX THERAPEUTICS LLC
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~ACCORD HLTHCARE~5MG~A~078155~005~AB~Apr 5, 2
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~ACCORD HLTHCARE~10MG~A~078155~002~AB~Feb 26,
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~AUROBINDO PHARMA~5MG~A~077691~001~AB~Dec 20,
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~AUROBINDO PHARMA~10MG~A~077691~002~AB~Dec 20
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~BLU CARIBE~5MG~A~078034~001~AB~Dec 20, 2006~
No~RX~BLU CARIBE INC
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~BLU CARIBE~10MG~A~078034~002~AB~Dec 20, 2006
~No~RX~BLU CARIBE INC

SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~DR REDDYS LABS INC~5MG~A~077752~005~AB~Jan 2
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~DR REDDYS LABS INC~10MG~A~077752~001~AB~Dec
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~HETERO LABS LTD III~5MG~A~200895~001~AB~Nov
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~IVAX SUB TEVA PHARMS~5MG~A~076052~001~AB~Jun
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~IVAX SUB TEVA PHARMS~10MG~A~076052~002~AB~Ju
n 23, 2006~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~IVAX SUB TEVA PHARMS~80MG~A~076052~005~AB~De
c 20, 2006~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~LUPIN~5MG~A~078103~005~AB~Apr 14, 2009~No~RX
~LUPIN LTD
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~LUPIN~10MG~A~078103~001~AB~May 11, 2007~No~R
X~LUPIN LTD
X~LUPIN LTD
X~LUPIN LTD
X~LUPIN LTD
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~MICRO LABS LTD~5MG~A~090383~001~AB~Sep 16, 2
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~MICRO LABS LTD~10MG~A~090383~002~AB~Sep 16,
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~MYLAN PHARMS INC~5MG~A~090868~001~AB~Jun 8,

SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~PROSAM LABS~5MG~A~078735~001~AB~Aug 30, 2010
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~RANBAXY~5MG~A~076285~001~AB~Dec 20, 2006~No~
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~RANBAXY~10MG~A~076285~002~AB~Dec 20, 2006~No
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~RANBAXY~80MG~A~076285~005~AB~Jun 23, 2006~No
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~SANDOZ INC~5MG~A~077766~001~~Dec 20, 2006~No
~DISCN~SANDOZ INC
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~SANDOZ INC~10MG~A~077766~002~~Dec 20, 2006~N
o~DISCN~SANDOZ INC
o~DISCN~SANDOZ INC
o~DISCN~SANDOZ INC
o~DISCN~SANDOZ INC
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~WATSON LABS~5MG~A~076685~001~AB~Dec 20, 2006
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~ZYDUS PHARMS USA~5MG~A~077837~001~AB~Dec 20,
SIMVASTATIN~TABLET;ORAL~SIMVASTATIN~ZYDUS PHARMS USA~10MG~A~077837~002~AB~Dec 20
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET;ORAL~SINE-AID IB~MCNEIL CONS~200
MG;30MG~N~019899~001~~Dec 31, 1992~No~OTC~MCNEIL CONSUMER HEALTHCARE
CARBIDOPA; LEVODOPA~TABLET;ORAL~SINEMET~MERCK SHARP DOHME~10MG;100MG~N~017555~00
1~AB~Approved Prior to Jan 1, 1982~No~RX~MERCK SHARP AND DOHME CORP
3~AB~Approved Prior to Jan 1, 1982~No~RX~MERCK SHARP AND DOHME CORP

2~AB~Approved Prior to Jan 1, 1982~Yes~RX~MERCK SHARP AND DOHME CORP
MONTELUKAST SODIUM~TABLET;ORAL~SINGULAIR~MERCK~EQ 10MG BASE~N~020829~002~AB~Feb
20, 1998~Yes~RX~MERCK RESEARCH LABORATORIES DIV MERCK CO INC
SIROLIMUS~TABLET;ORAL~SIROLIMUS~DR REDDYS LABS LTD~1MG~A~201578~001~AB~Oct 27, 2
SIROLIMUS~TABLET;ORAL~SIROLIMUS~DR REDDYS LABS LTD~2MG~A~201578~002~AB~Oct 27, 2
SIROLIMUS~TABLET;ORAL~SIROLIMUS~ZYDUS PHARMS USA INC~0.5MG~A~201676~003~AB~Jan 8
BEDAQUILINE FUMARATE~TABLET;ORAL~SIRTURO~JANSSEN THERAP~EQ 100MG BASE~N~204384~0
01~~Dec 28, 2012~Yes~RX~JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP
TEDIZOLID PHOSPHATE~TABLET;ORAL~SIVEXTRO~CUBIST PHARMS INC~200MG~N~205435~001~~J
un 20, 2014~Yes~RX~CUBIST PHARMACEUTICALS INC
METAXALONE~TABLET;ORAL~SKELAXIN~KING PHARMS~400MG **Federal Register determinati
**~N~013217~001~~Approved Prior to Jan 1, 1982~No~DISCN~KING PHARMACEUTICALS INC
METAXALONE~TABLET;ORAL~SKELAXIN~KING PHARMS~800MG~N~013217~003~AB~Aug 30, 2002~Y
es~RX~KING PHARMACEUTICALS INC
TILUDRONATE DISODIUM~TABLET;ORAL~SKELID~SANOFI AVENTIS US~EQ 200MG BASE~N~020707
~001~~Mar 7, 1997~No~DISCN~SANOFI AVENTIS US LLC
THEOPHYLLINE~TABLET;ORAL~SLO-PHYLLIN~SANOFI AVENTIS US~100MG~A~085202~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
THEOPHYLLINE~TABLET;ORAL~SLO-PHYLLIN~SANOFI AVENTIS US~200MG~A~085204~001~~Appro
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~HIKMA PHARMS LLC~15MG~A~0854
18~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTICALS LLC
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~HIKMA PHARMS LLC~30MG~A~0854
32~001~~Approved Prior to Jan 1, 1982~No~DISCN~HIKMA PHARMACEUTICALS LLC
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~IVAX SUB TEVA PHARMS~15MG~A~
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~IVAX SUB TEVA PHARMS~30MG~A~
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~LANNETT~15MG~A~085849~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~LANNETT~30MG~A~085866~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~LANNETT~100MG~A~085881~001~~
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~MARSHALL PHARMA~16.2MG~A~083
524~001~~Approved Prior to Jan 1, 1982~No~DISCN~MARSHALL PHARMACAL CORP
BUTABARBITAL SODIUM~TABLET;ORAL~SODIUM BUTABARBITAL~MARSHALL PHARMA~32.4MG~A~083
858~001~~Approved Prior to Jan 1, 1982~No~DISCN~MARSHALL PHARMACAL CORP
AMINOSALICYLATE SODIUM~TABLET;ORAL~SODIUM P.A.S.~LANNETT~500MG~A~080138~002~~App
roved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC
PENTOBARBITAL SODIUM~TABLET;ORAL~SODIUM PENTOBARBITAL~NEXGEN PHARMA INC~100MG~A~
084238~001~~Approved Prior to Jan 1, 1982~No~DISCN~NEXGEN PHARMA INC
SODIUM PHENYLBUTYRATE~TABLET;ORAL~SODIUM PHENYLBUTYRATE~AMPOLGEN~500MG~A~090910~
001~AB~Nov 18, 2011~No~RX~AMPOLGEN PHARMACEUTICALS LLC
SOLIFENACIN SUCCINATE~TABLET;ORAL~SOLIFENACIN SUCCINATE~TEVA PHARMS USA~5MG~A~09
1464~001~AB~Apr 2, 2014~No~RX~TEVA PHARMACEUTICALS USA
SOLIFENACIN SUCCINATE~TABLET;ORAL~SOLIFENACIN SUCCINATE~TEVA PHARMS USA~10MG~A~0
91464~002~AB~Apr 2, 2014~No~RX~TEVA PHARMACEUTICALS USA
CARISOPRODOL~TABLET;ORAL~SOMA~MEDA PHARMS~250MG~N~011792~004~~Sep 13, 2007~Yes~R
X~MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC
CARISOPRODOL~TABLET;ORAL~SOMA~MEDA PHARMS~350MG~N~011792~001~AA~Approved Prior t
o Jan 1, 1982~No~RX~MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC
ASPIRIN; CARISOPRODOL~TABLET;ORAL~SOMA COMPOUND~MEDA PHARMS~325MG;200MG~N~012365

~005~AB~Jul 11, 1983~Yes~RX~MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC
ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE~TABLET;ORAL~SOMA COMPOUND W/ CODEINE~ME
DA PHARMS~325MG;200MG;16MG~N~012366~002~AB~Jul 11, 1983~Yes~RX~MEDA PHARMACEUTIC
ALS MEDA PHARMACEUTICALS INC
ISOSORBIDE DINITRATE~TABLET;ORAL~SORBITRATE~ASTRAZENECA~5MG~N~016192~001~~Apr 1,
1996~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
ISOSORBIDE DINITRATE~TABLET;ORAL~SORBITRATE~ASTRAZENECA~10MG~N~016192~002~~Apr 1
, 1996~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
ISOSORBIDE DINITRATE~TABLET;ORAL~SORBITRATE~ASTRAZENECA~20MG~A~086405~002~~Aug 2
1, 1990~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SORINE~UPSHER SMITH~80MG~A~075500~001~AB1~Apr
SULFISOXAZOLE~TABLET;ORAL~SOSOL~MK LABS~500MG~A~080036~001~~Approved Prior to Ja
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~APOTEX~80MG~A~076214~001
~AB2~Aug 27, 2003~No~RX~APOTEX INC
2~AB2~Aug 27, 2003~No~RX~APOTEX INC
3~AB2~Aug 27, 2003~No~RX~APOTEX INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~APOTEX INC~80MG~A~076140
~001~AB1~Sep 26, 2002~No~RX~APOTEX INC ETOBICOKE SITE
0~002~AB1~Sep 26, 2002~No~RX~APOTEX INC ETOBICOKE SITE
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~EPIC PHARMA INC~80MG~A~0
77070~001~AB2~Nov 4, 2005~No~RX~EPIC PHARMA INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~EPIC PHARMA INC~120MG~A~
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~EPIC PHARMA INC~160MG~A~
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~IMPAX PHARMS~80MG~A~0756
63~001~AB1~Nov 7, 2000~No~RX~IMPAX PHARMACEUTICALS
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~MUTUAL PHARM~80MG~A~0755
15~001~~Oct 15, 2001~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
76~001~~Apr 8, 2004~No~DISCN~MUTUAL PHARMACEUTICAL CO INC

SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~MYLAN~80MG~A~075237~001~
AB1~May 1, 2000~No~RX~MYLAN PHARMACEUTICALS INC
AB1~Dec 19, 2000~No~RX~MYLAN PHARMACEUTICALS INC
AB2~Feb 7, 2007~No~RX~MYLAN PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~MYLAN~120MG~A~075237~002
~AB1~May 1, 2000~No~RX~MYLAN PHARMACEUTICALS INC
~AB1~Dec 19, 2000~No~RX~MYLAN PHARMACEUTICALS INC
~AB2~Feb 7, 2007~No~RX~MYLAN PHARMACEUTICALS INC
~AB2~Feb 7, 2007~No~RX~MYLAN PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~SANDOZ~80MG~A~075366~001
~AB1~May 1, 2000~No~RX~SANDOZ INC
2~AB1~May 1, 2000~No~RX~SANDOZ INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~TEVA~80MG~A~075429~001~A
B1~May 1, 2000~No~RX~TEVA PHARMACEUTICALS USA INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~TEVA~80MG~A~076883~001~A
B2~Jul 26, 2004~No~RX~TEVA PHARMACEUTICALS USA INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~TEVA~120MG~A~075429~002~
AB1~May 1, 2000~No~RX~TEVA PHARMACEUTICALS USA INC
AB2~Jul 26, 2004~No~RX~TEVA PHARMACEUTICALS USA INC
AB2~Jul 26, 2004~No~RX~TEVA PHARMACEUTICALS USA INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~VINTAGE PHARMS~80MG~A~07
5563~001~AB1~Nov 7, 2003~No~RX~VINTAGE PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE~TABLET;ORAL~SOTALOL HYDROCHLORIDE~WATSON LABS~80MG~A~07523

SOFOSBUVIR~TABLET;ORAL~SOVALDI~GILEAD SCIENCES INC~400MG~N~204671~001~~Dec 6, 20
SULFISOXAZOLE~TABLET;ORAL~SOXAZOLE~ALRA~500MG~A~080366~001~~Approved Prior to Ja
n 1, 1982~No~DISCN~ALRA LABORATORIES INC
PROMAZINE HYDROCHLORIDE~TABLET;ORAL~SPARINE~WYETH AYERST~10MG~N~010348~006~~Appr
oved Prior to Jan 1, 1982~No~DISCN~WYETH AYERST LABORATORIES
PROMAZINE HYDROCHLORIDE~TABLET;ORAL~SPARINE~WYETH AYERST~100MG~N~010348~003~~App
PROMAZINE HYDROCHLORIDE~TABLET;ORAL~SPARINE~WYETH AYERST~200MG~N~010348~004~~App
CEFDITOREN PIVOXIL~TABLET;ORAL~SPECTRACEF~VANSEN PHARMA~200MG~N~021222~001~~Aug
29, 2001~No~RX~VANSEN PHARMA
CEFDITOREN PIVOXIL~TABLET;ORAL~SPECTRACEF~VANSEN PHARMA~400MG~N~021222~002~~Jul
21, 2008~Yes~RX~VANSEN PHARMA
BACAMPICILLIN HYDROCHLORIDE~TABLET;ORAL~SPECTROBID~PFIZER~400MG~N~050520~001~~Ap
BACAMPICILLIN HYDROCHLORIDE~TABLET;ORAL~SPECTROBID~PFIZER~800MG~N~050520~002~~Se
p 12, 1983~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~ACTAVIS ELIZABETH~25MG~A~040353~003~AB
~Mar 15, 2006~No~RX~ACTAVIS ELIZABETH LLC
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~ACTAVIS ELIZABETH~50MG~A~040353~001~AB
~Jul 29, 1999~No~RX~ACTAVIS ELIZABETH LLC
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~ACTAVIS ELIZABETH~100MG~A~040353~002~A
B~Jul 29, 1999~No~RX~ACTAVIS ELIZABETH LLC
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~AMNEAL PHARMS~25MG~A~091426~001~AB~Jun
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~AMNEAL PHARMS~50MG~A~091426~002~AB~Jun
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~AMNEAL PHARMS~100MG~A~091426~003~AB~Ju
n 8, 2010~No~RX~AMNEAL PHARMACEUTICALS
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~ASCOT~25MG~A~087687~001~~Oct 20, 1982~
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~IVAX PHARMS~25MG~A~087108~001~~Approve
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~JUBILANT GENERICS~25MG~A~203253~001~AB
~Apr 23, 2014~No~RX~JUBILANT GENERICS LTD
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~JUBILANT GENERICS~50MG~A~203253~002~AB
~Apr 23, 2014~No~RX~JUBILANT GENERICS LTD
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~JUBILANT GENERICS~100MG~A~203253~003~A
B~Apr 23, 2014~No~RX~JUBILANT GENERICS LTD
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~LEDERLE~25MG~A~087634~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~MUTUAL PHARM~25MG~A~087265~001~~Approv
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~MUTUAL PHARM~25MG~A~089424~001~AB~Jul
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~MUTUAL PHARM~50MG~A~089424~002~AB~Aug
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~MUTUAL PHARM~100MG~A~089424~003~AB~Aug

SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~MYLAN~25MG~A~040424~001~AB~Aug 20, 200
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~MYLAN~25MG~A~087086~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~ORION CORP ORION~25MG~A~202187~001~AB~
Mar 6, 2014~No~RX~ORION CORP ORION PHARMA
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~ORION CORP ORION~50MG~A~202187~002~AB~
Mar 6, 2014~No~RX~ORION CORP ORION PHARMA
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~ORION CORP ORION~100MG~A~202187~003~AB
~Mar 6, 2014~No~RX~ORION CORP ORION PHARMA
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~PUREPAC PHARM~25MG~A~087998~001~~Oct 1
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~PUREPAC PHARM~25MG~A~088053~001~~Aug 2
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~SANDOZ~25MG~A~086809~001~AB~Approved P
rior to Jan 1, 1982~No~RX~SANDOZ INC
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~SUPERPHARM~25MG~A~089364~001~~Nov 7, 1
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~UPSHER SMITH~25MG~A~087554~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~UPSHER SMITH LABORATORIES INC
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~VANGARD~25MG~A~087648~001~~Feb 1, 1982
~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~VINTAGE~25MG~A~040750~001~AB~Aug 29, 2
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~VINTAGE~50MG~A~040750~002~AB~Aug 29, 2
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~VINTAGE~100MG~A~040750~003~AB~Aug 29,
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~WARNER CHILCOTT~25MG~A~087952~001~~Nov
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~WATSON LABS~25MG~A~086898~002~~Mar 2,
SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE~WATSON LABS~25MG~A~087078~001~~Approve
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE AND HYDROCHLOROTH
IAZIDE~ASCOT~25MG;25MG~A~088025~001~~Nov 23, 1984~No~DISCN~ASCOT HOSP PHARMACEUT
ICALS INC DIV TRAVENOL LABORATORIES INC
IAZIDE~MUTUAL PHARM~25MG;25MG~A~087267~001~~Approved Prior to Jan 1, 1982~No~DIS
CN~MUTUAL PHARMACEUTICAL CO INC
IAZIDE~MUTUAL PHARM~25MG;25MG~A~089534~001~AB~Jul 2, 1987~No~RX~MUTUAL PHARMACEU
TICAL CO INC
IAZIDE~MYLAN~25MG;25MG~A~086513~001~AB~Approved Prior to Jan 1, 1982~No~RX~MYLAN
PHARMACEUTICALS INC
IAZIDE~PUREPAC PHARM~25MG;25MG~A~087999~001~~Nov 6, 1985~No~DISCN~PUREPAC PHARMA
CEUTICAL CO
IAZIDE~SANDOZ~25MG;25MG~A~086881~001~~Approved Prior to Jan 1, 1982~No~DISCN~SAN
DOZ INC
IAZIDE~SUPERPHARM~25MG;25MG~A~089137~001~~Aug 26, 1985~No~DISCN~SUPERPHARM CORP
IAZIDE~WATSON LABS~25MG;25MG~A~087398~001~~Approved Prior to Jan 1, 1982~No~DISC

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE~TABLET;ORAL~SPIRONOLACTONE W/ HYDROCHLOROTHI
AZIDE~IVAX PHARMS~25MG;25MG~A~087004~002~~May 24, 1982~No~DISCN~IVAX PHARMACEUTI
CALS INC
AZIDE~LEDERLE~25MG;25MG~A~087511~001~~Approved Prior to Jan 1, 1982~No~DISCN~LED
ERLE LABORATORIES DIV AMERICAN CYANAMID CO
AZIDE~PARKE DAVIS~25MG;25MG~A~087948~001~~Feb 22, 1983~No~DISCN~PARKE DAVIS DIV
WARNER LAMBERT CO
AZIDE~PUREPAC PHARM~25MG;25MG~A~088054~001~~Aug 18, 1983~No~DISCN~PUREPAC PHARMA
CEUTICAL CO
AZIDE~UPSHER SMITH~25MG;25MG~A~087553~001~~Approved Prior to Jan 1, 1982~No~DISC
N~UPSHER SMITH LABORATORIES INC
AZIDE~USL PHARMA~25MG;25MG~A~087651~001~~Approved Prior to Jan 1, 1982~No~DISCN~
USL PHARMA INC
AZIDE~VANGARD~25MG;25MG~A~087655~001~~Approved Prior to Jan 1, 1982~No~DISCN~VAN
GARD LABORATORIES INC DIV MIDWAY MEDICAL CO
AZIDE~WATSON LABS~25MG;25MG~A~085974~001~~Approved Prior to Jan 1, 1982~No~DISCN
AZIDE~WATSON LABS~25MG;25MG~A~086026~001~~Approved Prior to Jan 1, 1982~No~DISCN
DASATINIB~TABLET;ORAL~SPRYCEL~BRISTOL MYERS SQUIBB~20MG~N~021986~001~~Jun 28, 20
DASATINIB~TABLET;ORAL~SPRYCEL~BRISTOL MYERS SQUIBB~80MG~N~021986~005~~Oct 28, 20
DASATINIB~TABLET;ORAL~SPRYCEL~BRISTOL MYERS SQUIBB~100MG~N~021986~004~~May 30, 2
DASATINIB~TABLET;ORAL~SPRYCEL~BRISTOL MYERS SQUIBB~140MG~N~021986~006~~Oct 28, 2
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~STALEVO 100~ORION PHARMA~25MG;200MG;
100MG~N~021485~002~AB~Jun 11, 2003~No~RX~ORION PHARMA
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~STALEVO 125~ORION PHARMA~31.25MG;200
MG;125MG~N~021485~006~AB~Aug 29, 2008~No~RX~ORION PHARMA
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~STALEVO 150~ORION PHARMA~37.5MG;200M
G;150MG~N~021485~003~AB~Jun 11, 2003~No~RX~ORION PHARMA
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~STALEVO 200~ORION PHARMA~50MG;200MG;
200MG~N~021485~004~AB~Aug 2, 2007~Yes~RX~ORION PHARMA
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~STALEVO 50~ORION PHARMA~12.5MG;200MG
;50MG~N~021485~001~AB~Jun 11, 2003~Yes~RX~ORION PHARMA
CARBIDOPA; ENTACAPONE; LEVODOPA~TABLET;ORAL~STALEVO 75~ORION PHARMA~18.75MG;200M
G;75MG~N~021485~005~AB~Aug 29, 2008~No~RX~ORION PHARMA
ISONIAZID~TABLET;ORAL~STANOZIDE~EVERYLIFE~100MG~A~080126~001~~Approved Prior to
ISONIAZID~TABLET;ORAL~STANOZIDE~EVERYLIFE~300MG~A~080126~002~~Approved Prior to
NATEGLINIDE~TABLET;ORAL~STARLIX~NOVARTIS~60MG~N~021204~001~AB~Dec 22, 2000~No~RX
NATEGLINIDE~TABLET;ORAL~STARLIX~NOVARTIS~120MG~N~021204~002~AB~Dec 22, 2000~Yes~

PHENDIMETRAZINE TARTRATE~TABLET;ORAL~STATOBEX~TEVA~35MG~A~086013~001~~Approved P
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~STATOBEX-G~TEVA~35MG~A~085095~001~~Approved
TRIFLUOPERAZINE HYDROCHLORIDE~TABLET;ORAL~STELAZINE~GLAXOSMITHKLINE~EQ 1MG BASE~
TRIFLUOPERAZINE HYDROCHLORIDE~TABLET;ORAL~STELAZINE~GLAXOSMITHKLINE~EQ 10MG BASE
AVANAFIL~TABLET;ORAL~STENDRA~VIVUS~50MG~N~202276~001~~Apr 27, 2012~No~RX~VIVUS I
NC
AVANAFIL~TABLET;ORAL~STENDRA~VIVUS~100MG~N~202276~002~~Apr 27, 2012~No~RX~VIVUS
INC
AVANAFIL~TABLET;ORAL~STENDRA~VIVUS~200MG~N~202276~003~~Apr 27, 2012~Yes~RX~VIVUS
INC
PREDNISOLONE~TABLET;ORAL~STERANE~PFIZER~5MG~N~009996~001~~Approved Prior to Jan
DIETHYLSTILBESTROL~TABLET;ORAL~STILBESTROL~TABLICAPS~0.5MG~A~083004~001~~Approve
d Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
DIETHYLSTILBESTROL~TABLET;ORAL~STILBESTROL~TABLICAPS~1MG~A~083002~001~~Approved
Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
DIETHYLSTILBESTROL~TABLET;ORAL~STILBESTROL~TABLICAPS~5MG~A~083006~001~~Approved
Prior to Jan 1, 1982~No~DISCN~TABLICAPS INC
DIETHYLSTILBESTROL~TABLET;ORAL~STILBETIN~BRISTOL MYERS SQUIBB~0.1MG~N~004056~007
~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
7~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
DIETHYLSTILBESTROL~TABLET;ORAL~STILBETIN~BRISTOL MYERS SQUIBB~1MG~N~004056~009~~
Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
DIETHYLSTILBESTROL~TABLET;ORAL~STILBETIN~BRISTOL MYERS SQUIBB~5MG~N~004056~010~~
Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB
DIETHYLSTILBESTROL DIPHOSPHATE~TABLET;ORAL~STILPHOSTROL~BAYER PHARMS~50MG~N~0100
10~002~~Approved Prior to Jan 1, 1982~No~DISCN~BAYER PHARMACEUTICALS CORP
REGORAFENIB~TABLET;ORAL~STIVARGA~BAYER HLTHCARE~40MG~N~203085~001~~Sep 27, 2012~
Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE~TABLET;OR
AL~STRIBILD~GILEAD SCIENCES INC~150MG;150MG;200MG;300MG~N~203100~001~~Aug 27, 20
CHLORZOXAZONE~TABLET;ORAL~STRIFON FORTE DSC~FERNDALE LABS~500MG~A~081008~001~~De
c 23, 1988~No~DISCN~FERNDALE LABORATORIES INC
IVERMECTIN~TABLET;ORAL~STROMECTOL~MERCK SHARP DOHME~3MG~N~050742~002~AB~Oct 8, 1
IVERMECTIN~TABLET;ORAL~STROMECTOL~MERCK SHARP DOHME~6MG~N~050742~001~~Nov 22, 19
96~No~DISCN~MERCK SHARP AND DOHME CORP
SUCRALFATE~TABLET;ORAL~SUCRALFATE~NOSTRUM LABS~1GM~A~074415~001~AB~Jun 8, 1998~N
o~RX~NOSTRUM LABORATORIES INC
SUCRALFATE~TABLET;ORAL~SUCRALFATE~TEVA~1GM~A~070848~001~AB~Mar 29, 1996~No~RX~TE
TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)~TABLET;ORAL~SULF
A-TRIPLE #2~IMPAX LABS~167MG;167MG;167MG~A~080079~001~~Approved Prior to Jan 1,
1982~No~DISCN~IMPAX LABORATORIES INC
SULFAPHENAZOLE~TABLET;ORAL~SULFABID~PURDUE FREDERICK~500MG~N~013092~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~PURDUE FREDERICK CO
SULFADIAZINE~TABLET;ORAL~SULFADIAZINE~ABBVIE~300MG~N~004125~005~~Approved Prior

SULFADIAZINE~TABLET;ORAL~SULFADIAZINE~EVERYLIFE~500MG~A~080088~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~EVERYLIFE
SULFADIAZINE~TABLET;ORAL~SULFADIAZINE~IMPAX LABS~500MG~A~080081~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
SULFADIAZINE~TABLET;ORAL~SULFADIAZINE~LANNETT~500MG~A~080084~001~~Approved Prior
SULFADIAZINE~TABLET;ORAL~SULFADIAZINE~LEDERLE~500MG~N~004054~001~~Approved Prior
SULFADIAZINE~TABLET;ORAL~SULFADIAZINE~LILLY~500MG~N~004122~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~ELI LILLY AND CO
SULFADIAZINE~TABLET;ORAL~SULFADIAZINE~SANDOZ~500MG~A~040091~001~~Jul 29, 1994~Ye
s~RX~SANDOZ INC
SULFISOXAZOLE~TABLET;ORAL~SULFALAR~PARKE DAVIS~500MG~A~084955~001~~Approved Prio
ALOID~FOREST PHARMS~167MG;167MG;167MG~A~080099~001~~Approved Prior to Jan 1, 198
2~No~DISCN~FOREST PHARMACEUTICALS INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOPRIM~NOVEL LABS INC~400MG;8
0MG~A~070022~001~~Feb 15, 1985~No~DISCN~NOVEL LABORATORIES INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOPRIM-DS~NOVEL LABS INC~800M
G;160MG~A~070032~001~~Feb 15, 1985~No~DISCN~NOVEL LABORATORIES INC
SULFAMETHOXAZOLE~TABLET;ORAL~SULFAMETHOXAZOLE~ASCOT~500MG~A~087662~001~~Oct 20,
1982~No~DISCN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
SULFAMETHOXAZOLE~TABLET;ORAL~SULFAMETHOXAZOLE~BARR~500MG~A~087189~001~~Jul 25, 1
SULFAMETHOXAZOLE~TABLET;ORAL~SULFAMETHOXAZOLE~HEATHER~500MG~A~086163~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
SULFAMETHOXAZOLE~TABLET;ORAL~SULFAMETHOXAZOLE~SANDOZ~500MG~A~085844~001~~Approve
SULFAMETHOXAZOLE~TABLET;ORAL~SULFAMETHOXAZOLE~WATSON LABS~1GM~A~086000~001~~Appr
oved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
SULFAMETHOXAZOLE~TABLET;ORAL~SULFAMETHOXAZOLE~WATSON LABS~500MG~A~085053~001~~Ap
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~AMN
EAL PHARMS NY~400MG;80MG~A~076899~001~AB~Jan 27, 2005~No~RX~AMNEAL PHARMACEUTICA
LS NY LLC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~AMN
EAL PHARMS NY~800MG;160MG~A~076899~002~AB~Jan 27, 2005~No~RX~AMNEAL PHARMACEUTIC
ALS NY LLC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~AUR
OBINDO PHARMA~400MG;80MG~A~090624~001~AB~Feb 16, 2010~No~RX~AUROBINDO PHARMA LTD
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~AUR
OBINDO PHARMA~800MG;160MG~A~090624~002~AB~Feb 16, 2010~No~RX~AUROBINDO PHARMA LT
D
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~GLE
NMARK GENERICS~400MG;80MG~A~090828~002~AB~Dec 22, 2010~No~RX~GLENMARK GENERICS L
TD
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~GLE
NMARK GENERICS~800MG;160MG~A~090828~001~AB~Dec 22, 2010~No~RX~GLENMARK GENERICS
LTD
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~HEA
THER~400MG;80MG~N~018946~001~~Aug 10, 1984~No~DISCN~HEATHER DRUG CO INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~HEA
THER~800MG;160MG~N~018946~002~~Aug 10, 1984~No~DISCN~HEATHER DRUG CO INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~INT
ERPHARM~400MG;80MG~A~071299~001~~Oct 27, 1987~No~DISCN~INTERPHARM INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~INT
ERPHARM~800MG;160MG~A~071300~001~~Oct 27, 1987~No~DISCN~INTERPHARM INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~MAR
TEC USA LLC~400MG;80MG~A~072408~001~~Dec 7, 1988~No~DISCN~MARTEC USA LLC

SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~MUT
UAL PHARM~400MG;80MG~A~070006~001~~Nov 14, 1984~No~DISCN~MUTUAL PHARMACEUTICAL C
O INC
UAL PHARM~400MG;80MG~A~071016~001~~Aug 25, 1986~No~DISCN~MUTUAL PHARMACEUTICAL C
O INC
UAL PHARM~800MG;160MG~A~071017~001~AB~Aug 25, 1986~No~RX~MUTUAL PHARMACEUTICAL C
O INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~PLI
VA~400MG;80MG~A~070215~001~~Sep 10, 1985~No~DISCN~PLIVA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~PLI
VA~800MG;160MG~A~070216~001~~Sep 10, 1985~No~DISCN~PLIVA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~ROX
ANE~400MG;80MG~A~072768~001~~Aug 30, 1991~No~DISCN~ROXANE LABORATORIES INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~SAN
DOZ~400MG;80MG~A~070889~001~~Nov 13, 1986~No~DISCN~SANDOZ INC
DOZ~400MG;80MG~N~018598~003~~May 19, 1982~No~DISCN~SANDOZ INC
DOZ~800MG;160MG~A~070890~001~~Nov 13, 1986~No~DISCN~SANDOZ INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~TEV
A~400MG;80MG~N~018242~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEU
TICALS USA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~TEV
A~800MG;160MG~N~018242~002~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACE
UTICALS USA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~USL
PHARMA~400MG;80MG~A~070203~001~~Nov 8, 1985~No~DISCN~USL PHARMA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~USL
PHARMA~800MG;160MG~A~070204~001~~Nov 8, 1985~No~DISCN~USL PHARMA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~VIN
TAGE~400MG;80MG~A~078060~002~AB~Jan 25, 2007~No~RX~VINTAGE PHARMACEUTICALS LLC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~VIN
TAGE~800MG;160MG~A~078060~001~AB~Jan 25, 2007~No~RX~VINTAGE PHARMACEUTICALS LLC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~VIS
TA PHARMS~400MG;80MG~A~076817~001~AB~Oct 7, 2005~No~RX~VISTA PHARMACEUTICALS INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~VIS
TA PHARMS~800MG;160MG~A~076817~002~AB~Oct 7, 2005~No~RX~VISTA PHARMACEUTICALS IN
C
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM~WAT
SON LABS~400MG;80MG~A~070002~001~~Nov 7, 1984~No~DISCN~WATSON LABORATORIES INC
SON LABS~400MG;80MG~N~018852~001~~May 9, 1983~No~DISCN~WATSON LABORATORIES INC
SON LABS~800MG;160MG~A~070000~001~~Nov 7, 1984~No~DISCN~WATSON LABORATORIES INC
PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAM
ETHOXAZOLE AND TRIMETHOPRIM AND PENAZOPYRIDINE HYDROCHLORIDE~ABLE~200MG,N/A,N/A;
N/A,800MG,160MG~N~021105~001~~Jun 26, 2001~No~DISCN~ABLE LABORATORIES INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM DOU
BLE STRENGTH~MARTEC USA LLC~800MG;160MG~A~072417~001~~Dec 7, 1988~No~DISCN~MARTE
C USA LLC
BLE STRENGTH~MUTUAL PHARM~800MG;160MG~A~070007~001~~Nov 14, 1984~No~DISCN~MUTUAL
PHARMACEUTICAL CO INC
BLE STRENGTH~ROXANE~800MG;160MG~A~072769~001~~Aug 30, 1991~No~DISCN~ROXANE LABOR
ATORIES INC
BLE STRENGTH~SANDOZ~800MG;160MG~N~018598~004~~May 19, 1982~No~DISCN~SANDOZ INC

BLE STRENGTH~TEVA~800MG;160MG~A~070037~001~AB~Jun 2, 1987~No~RX~TEVA PHARMACEUTI
CALS USA INC
BLE STRENGTH~WATSON LABS~800MG;160MG~N~018854~001~~May 9, 1983~No~DISCN~WATSON L
ABORATORIES INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFAMETHOXAZOLE AND TRIMETHOPRIM SIN
GLE STRENGTH~TEVA PHARMS~400MG;80MG~A~070030~001~AB~Jun 2, 1987~No~RX~TEVA PHARM
ACEUTICALS USA
SULFAPYRIDINE~TABLET;ORAL~SULFAPYRIDINE~LILLY~500MG~N~000159~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ELI LILLY AND CO
SULFASALAZINE~TABLET;ORAL~SULFASALAZINE~HERITAGE PHARMS INC~500MG~A~080197~001~~
Approved Prior to Jan 1, 1982~No~DISCN~HERITAGE PHARMACEUTICALS INC
SULFASALAZINE~TABLET;ORAL~SULFASALAZINE~MUTUAL PHARM~500MG~A~089590~001~~Oct 19,
SULFASALAZINE~TABLET;ORAL~SULFASALAZINE~SANDOZ~500MG~A~086184~001~~Approved Prio
SULFASALAZINE~TABLET;ORAL~SULFASALAZINE~SUPERPHARM~500MG~A~089339~001~~Oct 26, 1
SULFASALAZINE~TABLET;ORAL~SULFASALAZINE~VINTAGE PHARMS~500MG~A~040349~001~AB~Jan
SULFASALAZINE~TABLET;ORAL~SULFASALAZINE~WATSON LABS~500MG~A~084964~001~~Approved
SULFASALAZINE~TABLET;ORAL~SULFASALAZINE~WATSON LABS~500MG~A~085828~001~AB~Approv
SULFASALAZINE~TABLET;ORAL~SULFASALAZINE~WATSON LABS~500MG~A~087197~001~~Approved
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFATRIM-DS~SUPERPHARM~800MG;160MG~A
~070066~001~~Jun 24, 1985~No~DISCN~SUPERPHARM CORP
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~SULFATRIM-SS~SUPERPHARM~400MG;80MG~A~
070065~002~~Jun 24, 1985~No~DISCN~SUPERPHARM CORP
SULFINPYRAZONE~TABLET;ORAL~SULFINPYRAZONE~BARR~100MG~A~087665~001~~Sep 17, 1982~
SULFINPYRAZONE~TABLET;ORAL~SULFINPYRAZONE~IVAX PHARMS~100MG~A~087769~001~~Jun 1,
SULFINPYRAZONE~TABLET;ORAL~SULFINPYRAZONE~PAR PHARM~100MG~A~088933~001~~Sep 6, 1
SULFINPYRAZONE~TABLET;ORAL~SULFINPYRAZONE~WATSON LABS~100MG~A~087667~001~~May 26
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~BARR~500MG~A~084031~001~~Approved Prior
to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~HEATHER~500MG~A~080189~001~~Approved Pri
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~IMPAX LABS~500MG~A~080109~001~~Approved
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~IVAX SUB TEVA PHARMS~500MG~A~080142~001~
CEUTICALS USA
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~LANNETT~500MG~A~080085~001~~Approved Pri
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~LEDERLE~500MG~A~087649~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~PHARMERAL~500MG~A~084385~001~~Approved P
rior to Jan 1, 1982~No~DISCN~PHARMERAL INC
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~PUREPAC PHARM~500MG~A~080087~001~~Approv
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~ROXANE~500MG~A~080082~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~SANDOZ~500MG~A~085628~001~~Approved Prio

SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~VALEANT PHARM INTL~500MG~A~080268~002~~A
pproved Prior to Jan 1, 1982~No~DISCN~VALEANT PHARMACEUTICALS INTERNATIONAL
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~VITARINE~500MG~A~087332~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS INC
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~WATSON LABS~500MG~A~085534~001~~Approved
SULFISOXAZOLE~TABLET;ORAL~SULFISOXAZOLE~WEST WARD~500MG~A~080379~001~~Approved P
rior to Jan 1, 1982~No~DISCN~WEST WARD PHARMACEUTICAL CORP
OSE~WYETH AYERST~167MG;167MG;167MG~A~080013~001~~Approved Prior to Jan 1, 1982~N
o~DISCN~WYETH AYERST LABORATORIES
SULINDAC~TABLET;ORAL~SULINDAC~EPIC PHARMA~150MG~A~072710~001~AB~Mar 25, 1991~No~
RX~EPIC PHARMA LLC
SULINDAC~TABLET;ORAL~SULINDAC~EPIC PHARMA~200MG~A~072711~001~AB~Mar 25, 1991~No~
RX~EPIC PHARMA LLC
SULINDAC~TABLET;ORAL~SULINDAC~HERITAGE PHARMS INC~150MG~A~073262~002~AB~Sep 6, 1
SULINDAC~TABLET;ORAL~SULINDAC~HERITAGE PHARMS INC~200MG~A~073262~001~AB~Sep 6, 1
SULINDAC~TABLET;ORAL~SULINDAC~MUTUAL PHARM~150MG~A~072050~001~AB~Apr 17, 1991~No
SULINDAC~TABLET;ORAL~SULINDAC~MUTUAL PHARM~200MG~A~072051~001~AB~Apr 17, 1991~No
SULINDAC~TABLET;ORAL~SULINDAC~MYLAN~150MG~A~073039~002~AB~Jun 22, 1993~No~RX~MYL
SULINDAC~TABLET;ORAL~SULINDAC~MYLAN~200MG~A~073039~001~AB~Jun 22, 1993~No~RX~MYL
SULINDAC~TABLET;ORAL~SULINDAC~SANDOZ~150MG~A~072712~001~~Aug 30, 1991~No~DISCN~S
ANDOZ INC
SULINDAC~TABLET;ORAL~SULINDAC~SANDOZ~200MG~A~072713~001~~Aug 30, 1991~No~DISCN~S
ANDOZ INC
SULINDAC~TABLET;ORAL~SULINDAC~TEVA~150MG~A~072972~001~~Feb 28, 1992~No~DISCN~TEV
SULINDAC~TABLET;ORAL~SULINDAC~TEVA~200MG~A~072973~001~~Feb 28, 1992~No~DISCN~TEV
SULINDAC~TABLET;ORAL~SULINDAC~WATSON LABS~150MG~A~071891~001~AB~Apr 3, 1990~No~R
SULINDAC~TABLET;ORAL~SULINDAC~WATSON LABS~200MG~A~071795~001~AB~Apr 3, 1990~No~R
SULFAMETER~TABLET;ORAL~SULLA~BAYER HLTHCARE~500MG~N~016000~002~~Approved Prior t
o Jan 1, 1982~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
SULFISOXAZOLE~TABLET;ORAL~SULSOXIN~SOLVAY~500MG~A~080040~001~~Approved Prior to
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~APOTEX INC~EQ 25MG BASE~
A~200263~001~AB~Jun 19, 2012~No~RX~APOTEX INC
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~APOTEX INC~EQ 50MG BASE~
A~200263~002~AB~Jun 19, 2012~No~RX~APOTEX INC
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~APOTEX INC~EQ 100MG BASE
~A~200263~003~AB~Jun 19, 2012~No~RX~APOTEX INC
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~AUROBINDO PHARMA~EQ 25MG
BASE~A~078327~001~AB~Aug 10, 2009~No~RX~AUROBINDO PHARMA LTD
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~AUROBINDO PHARMA~EQ 50MG
BASE~A~078327~002~AB~Aug 10, 2009~No~RX~AUROBINDO PHARMA LTD
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~AUROBINDO PHARMA~EQ 100M
G BASE~A~078327~003~AB~Aug 10, 2009~No~RX~AUROBINDO PHARMA LTD
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~DR REDDYS LABS INC~EQ 25
MG BASE~A~076847~001~AB~Aug 10, 2009~No~RX~DR REDDYS LABORATORIES INC
MG BASE~A~076847~002~AB~Aug 10, 2009~No~RX~DR REDDYS LABORATORIES INC

0MG BASE~A~076847~003~AB~Aug 10, 2009~No~RX~DR REDDYS LABORATORIES INC
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~HIKMA PHARMS~EQ 25MG BAS
E~A~078298~001~AB~May 21, 2013~No~RX~HIKMA PHARMACEUTICALS
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~HIKMA PHARMS~EQ 50MG BAS
E~A~078298~002~AB~May 21, 2013~No~RX~HIKMA PHARMACEUTICALS
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~HIKMA PHARMS~EQ 100MG BA
SE~A~078298~003~AB~May 21, 2013~No~RX~HIKMA PHARMACEUTICALS
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~MYLAN~EQ 25MG BASE~A~077
163~001~~Nov 2, 2009~No~DISCN~MYLAN PHARMACEUTICALS INC
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~ORCHID HLTHCARE~EQ 25MG
BASE~A~078284~001~AB~Aug 10, 2009~No~RX~ORCHID HEALTHCARE
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~RANBAXY~EQ 25MG BASE~A~0
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~RANBAXY~EQ 50MG BASE~A~0
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~RANBAXY~EQ 100MG BASE~A~
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~ROXANE~EQ 25MG BASE~A~07
8241~001~~Aug 10, 2009~No~DISCN~ROXANE LABORATORIES INC
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~SANDOZ~EQ 25MG BASE~A~07
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~SUN PHARM INDS~EQ 25MG B
ASE~A~078295~001~AB~Aug 10, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~SUN PHARM INDS~EQ 50MG B
ASE~A~078295~002~AB~Aug 10, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~SUN PHARM INDS~EQ 100MG
BASE~A~078295~003~AB~Aug 10, 2009~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~TEVA~EQ 25MG BASE~A~0768
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~WATSON LABS~EQ 25MG BASE
~A~076933~001~AB~Aug 10, 2009~No~RX~WATSON LABORATORIES INC
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~WATSON LABS~EQ 50MG BASE
~A~076933~002~AB~Aug 10, 2009~No~RX~WATSON LABORATORIES INC
SUMATRIPTAN SUCCINATE~TABLET;ORAL~SUMATRIPTAN SUCCINATE~WATSON LABS~EQ 100MG BAS

E~A~076933~003~AB~Aug 10, 2009~No~RX~WATSON LABORATORIES INC
TETRACYCLINE HYDROCHLORIDE~TABLET;ORAL~SUMYCIN~PAR PHARM~50MG~A~061147~003~~Appr
oved Prior to Jan 1, 1982~No~DISCN~PAR PHARMACEUTICAL INC
TETRACYCLINE HYDROCHLORIDE~TABLET;ORAL~SUMYCIN~PAR PHARM~100MG~A~061147~002~~App
roved Prior to Jan 1, 1982~No~DISCN~PAR PHARMACEUTICAL INC
CEFIXIME~TABLET;ORAL~SUPRAX~LEDERLE~200MG **Federal Register determination that
621~001~~Apr 28, 1989~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
CEFIXIME~TABLET;ORAL~SUPRAX~LEDERLE~400MG~N~050621~002~~Apr 28, 1989~No~DISCN~LE
DERLE LABORATORIES DIV AMERICAN CYANAMID CO
CEFIXIME~TABLET;ORAL~SUPRAX~LUPIN PHARMS~400MG~A~065130~001~~Feb 12, 2004~Yes~RX
~LUPIN PHARMACEUTICALS INC
EFAVIRENZ~TABLET;ORAL~SUSTIVA~BRISTOL MYERS SQUIBB~300MG **Federal Register dete
reasons**~N~021360~001~~Feb 1, 2002~No~DISCN~BRISTOL MYERS SQUIBB CO
EFAVIRENZ~TABLET;ORAL~SUSTIVA~BRISTOL MYERS SQUIBB~600MG~N~021360~002~~Feb 1, 20
AMANTADINE HYDROCHLORIDE~TABLET;ORAL~SYMMETREL~ENDO PHARMS~100MG~N~018101~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUTICALS INC
MENADIOL SODIUM DIPHOSPHATE~TABLET;ORAL~SYNKAYVITE~ROCHE~5MG~N~003718~010~~Appro
ved Prior to Jan 1, 1982~No~DISCN~HOFFMANN LA ROCHE INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~SYNTHROID~ABBVIE~0.025MG **See current Annual E
~AB1,AB2~Jul 24, 2002~No~RX~ABBVIE INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~SYNTHROID~ABBVIE~0.05MG **See current Annual Ed
AB1,AB2~Jul 24, 2002~No~RX~ABBVIE INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~SYNTHROID~ABBVIE~0.1MG **See current Annual Edi
B1,AB2~Jul 24, 2002~No~RX~ABBVIE INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~SYNTHROID~ABBVIE~0.15MG **See current Annual Ed
AB1,AB2~Jul 24, 2002~No~RX~ABBVIE INC
B1,AB2~Jul 24, 2002~No~RX~ABBVIE INC

B1,AB2~Jul 24, 2002~Yes~RX~ABBVIE INC
IBUPROFEN~TABLET;ORAL~TAB-PROFEN~PERRIGO~200MG~A~072095~001~~Dec 8, 1987~No~OTC~
L PERRIGO CO
METHDILAZINE HYDROCHLORIDE~TABLET;ORAL~TACARYL~WESTWOOD SQUIBB~8MG~N~011950~006~
~Approved Prior to Jan 1, 1982~No~DISCN~WESTWOOD SQUIBB PHARMACEUTICALS INC
CIMETIDINE~TABLET;ORAL~TAGAMET~GLAXOSMITHKLINE~200MG~N~017920~002~~Approved Prio
CIMETIDINE~TABLET;ORAL~TAGAMET~GLAXOSMITHKLINE~300MG~N~017920~003~~Approved Prio
CIMETIDINE~TABLET;ORAL~TAGAMET~GLAXOSMITHKLINE~400MG~N~017920~004~~Dec 14, 1983~
No~DISCN~GLAXOSMITHKLINE
CIMETIDINE~TABLET;ORAL~TAGAMET~GLAXOSMITHKLINE~800MG~N~017920~005~~Apr 30, 1986~
No~DISCN~GLAXOSMITHKLINE
CIMETIDINE~TABLET;ORAL~TAGAMET HB~MEDTECH PRODUCTS~100MG~N~020238~001~~Jun 19, 1
995~No~DISCN~MEDTECH PRODUCTS INC
CIMETIDINE~TABLET;ORAL~TAGAMET HB~MEDTECH PRODUCTS~200MG~N~020238~002~~Aug 21, 1
996~Yes~OTC~MEDTECH PRODUCTS INC
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE~TABLET;ORAL~TALACEN~SANOFI AVENTIS US~6
50MG;EQ 25MG BASE~N~018458~001~~Sep 23, 1982~No~DISCN~SANOFI AVENTIS US LLC
PENTAZOCINE HYDROCHLORIDE~TABLET;ORAL~TALWIN 50~SANOFI AVENTIS US~EQ 50MG BASE~N
~016732~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
ASPIRIN; PENTAZOCINE HYDROCHLORIDE~TABLET;ORAL~TALWIN COMPOUND~SANOFI AVENTIS US
~325MG;EQ 12.5MG BASE~N~016891~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOF
I AVENTIS US LLC
NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE~TABLET;ORAL~TALWIN NX~SANOFI A
VENTIS US~EQ 0.5MG BASE;EQ 50MG BASE~N~018733~001~~Dec 16, 1982~No~DISCN~SANOFI
AVENTIS US LLC
FLECAINIDE ACETATE~TABLET;ORAL~TAMBOCOR~CNTY LINE PHARMS~50MG~N~018830~004~~Aug
23, 1988~No~DISCN~COUNTY LINE PHARMACEUTICALS LLC
FLECAINIDE ACETATE~TABLET;ORAL~TAMBOCOR~CNTY LINE PHARMS~100MG~N~018830~001~~Oct
FLECAINIDE ACETATE~TABLET;ORAL~TAMBOCOR~CNTY LINE PHARMS~150MG~N~018830~003~~Jun
FLECAINIDE ACETATE~TABLET;ORAL~TAMBOCOR~CNTY LINE PHARMS~200MG~N~018830~002~~Oct
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~ACTAVIS LABS FL INC~EQ 10MG BASE
~A~070929~001~AB~Feb 20, 2003~No~RX~ACTAVIS LABORATORIES FL INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~AEGIS PHARMS~EQ 10MG BASE~A~0763
98~001~~Mar 31, 2003~No~DISCN~AEGIS PHARMACEUTICALS INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~AEGIS PHARMS~EQ 20MG BASE~A~0763
98~002~~Mar 31, 2003~No~DISCN~AEGIS PHARMACEUTICALS INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~APOTEX~EQ 10MG BASE~A~090878~001
~AB~Sep 23, 2011~No~RX~APOTEX INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~APOTEX~EQ 20MG BASE~A~090878~002
~AB~Sep 23, 2011~No~RX~APOTEX INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~IVAX SUB TEVA PHARMS~EQ 10MG BAS
E~A~075740~001~~Feb 20, 2003~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACE
UTICALS USA
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~IVAX SUB TEVA PHARMS~EQ 20MG BAS
E~A~075740~002~~Feb 20, 2003~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACE
UTICALS USA
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~MYLAN~EQ 10MG BASE~A~074732~002~
AB~Feb 20, 2003~No~RX~MYLAN PHARMACEUTICALS INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~MYLAN~EQ 20MG BASE~A~074732~001~

AB~Feb 20, 2003~No~RX~MYLAN PHARMACEUTICALS INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~PHARMACHEMIE~EQ 10MG BASE~A~0745
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~ROXANE~EQ 10MG BASE~A~076027~001
~~Feb 20, 2003~No~DISCN~ROXANE LABORATORIES INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~ROXANE~EQ 20MG BASE~A~076027~002
~~Feb 20, 2003~No~DISCN~ROXANE LABORATORIES INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~TEVA~EQ 10MG BASE~A~074504~001~~
Apr 28, 2003~No~DISCN~TEVA PHARMACEUTICALS USA INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~TEVA~EQ 10MG BASE~A~075797~001~A
B~Feb 20, 2003~No~RX~TEVA PHARMACEUTICALS USA INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~TEVA~EQ 20MG BASE~A~074504~002~~
Apr 28, 2003~No~DISCN~TEVA PHARMACEUTICALS USA INC
TAMOXIFEN CITRATE~TABLET;ORAL~TAMOXIFEN CITRATE~TEVA PHARMS~EQ 20MG BASE~A~07485
8~001~AB~Feb 20, 2003~Yes~RX~TEVA PHARMACEUTICALS USA
OXYPHENBUTAZONE~TABLET;ORAL~TANDEARIL~NOVARTIS~100MG~N~012542~004~~Sep 3, 1982~N
o~DISCN~NOVARTIS PHARMACEUTICALS CORP
METHIMAZOLE~TABLET;ORAL~TAPAZOLE~KING PHARMS~5MG~A~040320~001~AB~Mar 31, 2000~No
~RX~KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS I
NC
METHIMAZOLE~TABLET;ORAL~TAPAZOLE~KING PHARMS~5MG~N~007517~002~~Approved Prior to
Jan 1, 1982~No~DISCN~KING PHARMACEUTICALS INC
METHIMAZOLE~TABLET;ORAL~TAPAZOLE~KING PHARMS~10MG~A~040320~002~AB~Mar 31, 2000~N
o~RX~KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS
INC
METHIMAZOLE~TABLET;ORAL~TAPAZOLE~KING PHARMS~10MG~N~007517~004~~Approved Prior t
o Jan 1, 1982~No~DISCN~KING PHARMACEUTICALS INC
CHLORPROTHIXENE~TABLET;ORAL~TARACTAN~ROCHE~10MG~N~012486~005~~Approved Prior to
ERLOTINIB HYDROCHLORIDE~TABLET;ORAL~TARCEVA~OSI PHARMS~EQ 25MG BASE~N~021743~001
~AB~Nov 18, 2004~No~RX~OSI PHARMACEUTICALS INC
2~AB~Nov 18, 2004~No~RX~OSI PHARMACEUTICALS INC
3~AB~Nov 18, 2004~Yes~RX~OSI PHARMACEUTICALS INC
TOLCAPONE~TABLET;ORAL~TASMAR~VALEANT PHARMS LLC~100MG~N~020697~001~~Jan 29, 1998
~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
TOLCAPONE~TABLET;ORAL~TASMAR~VALEANT PHARMS LLC~200MG~N~020697~002~~Jan 29, 1998
~No~DISCN~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
CLEMASTINE FUMARATE~TABLET;ORAL~TAVIST~NOVARTIS~2.68MG~N~017661~001~~Approved Pr
ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE~TABLET;ORAL~TA
VIST ALLERGY/SINUS/HEADACHE~NOVARTIS~500MG;EQ 0.25MG BASE;30MG~N~021082~001~~Mar
1, 2001~No~DISCN~NOVARTIS CONSUMER HEALTH INC
CLEMASTINE FUMARATE~TABLET;ORAL~TAVIST-1~NOVARTIS~1.34MG~N~017661~002~~Approved
Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
CLEMASTINE FUMARATE~TABLET;ORAL~TAVIST-1~NOVARTIS~1.34MG~N~017661~003~~Aug 21, 1
CLEMASTINE FUMARATE~TABLET;ORAL~TAVIST-1~NOVARTIS~1.34MG~N~020925~001~~Aug 21, 1
992~Yes~OTC~NOVARTIS PHARMACEUTICALS CORP
AMINOSALICYLATE SODIUM~TABLET;ORAL~TEEBACIN~CONSOLIDATED MIDLAND~500MG~N~007320~
002~~Approved Prior to Jan 1, 1982~No~DISCN~CONSOLIDATED MIDLAND CORP
CARBAMAZEPINE~TABLET;ORAL~TEGRETOL~NOVARTIS~200MG~N~016608~001~AB~Approved Prior
to Jan 1, 1982~Yes~RX~NOVARTIS PHARMACEUTICALS CORP

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE~TABLET;ORAL~TEKAMLO~NOVARTIS~EQ 150M
G BASE;EQ 5MG BASE~N~022545~001~~Aug 26, 2010~No~RX~NOVARTIS PHARMACEUTICALS COR
P
G BASE;EQ 10MG BASE~N~022545~002~~Aug 26, 2010~No~RX~NOVARTIS PHARMACEUTICALS CO
RP
G BASE;EQ 5MG BASE~N~022545~003~~Aug 26, 2010~No~RX~NOVARTIS PHARMACEUTICALS COR
P
G BASE;EQ 10MG BASE~N~022545~004~~Aug 26, 2010~Yes~RX~NOVARTIS PHARMACEUTICALS C
ORP
ALISKIREN HEMIFUMARATE~TABLET;ORAL~TEKTURNA~NOVARTIS~EQ 150MG BASE~N~021985~001~
~Mar 5, 2007~No~RX~NOVARTIS PHARMACEUTICALS CORP
ALISKIREN HEMIFUMARATE~TABLET;ORAL~TEKTURNA~NOVARTIS~EQ 300MG BASE~N~021985~002~
~Mar 5, 2007~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~TEKTURNA HCT~NOVARTIS~EQ
150MG BASE;12.5MG~N~022107~001~~Jan 18, 2008~No~RX~NOVARTIS PHARMACEUTICALS COR
P
150MG BASE;25MG~N~022107~002~~Jan 18, 2008~No~RX~NOVARTIS PHARMACEUTICALS CORP
300MG BASE;12.5MG~N~022107~003~~Jan 18, 2008~Yes~RX~NOVARTIS PHARMACEUTICALS CO
RP
300MG BASE;25MG~N~022107~004~~Jan 18, 2008~Yes~RX~NOVARTIS PHARMACEUTICALS CORP
IOPANOIC ACID~TABLET;ORAL~TELEPAQUE~GE HEALTHCARE~500MG~N~008032~001~~Approved P
rior to Jan 1, 1982~No~DISCN~GE HEALTHCARE
TELMISARTAN~TABLET;ORAL~TELMISARTAN~ALEMBIC PHARMS LTD~20MG~A~202130~001~AB~Jul
TELMISARTAN~TABLET;ORAL~TELMISARTAN~GLENMARK GENERICS~20MG~A~090032~001~AB~Jul 7
TELMISARTAN~TABLET;ORAL~TELMISARTAN~MYLAN PHARMS INC~20MG~A~202397~001~AB~Jul 7,
TELMISARTAN~TABLET;ORAL~TELMISARTAN~SANDOZ~20MG~A~203867~001~AB~Nov 3, 2014~No~R
X~SANDOZ INC
X~SANDOZ INC
X~SANDOZ INC
TELMISARTAN~TABLET;ORAL~TELMISARTAN~TORRENT PHARMS LTD~20MG~A~203171~001~AB~Jul
TELMISARTAN~TABLET;ORAL~TELMISARTAN~WATSON LABS~20MG~A~078710~001~AB~Jan 8, 2014

TELMISARTAN~TABLET;ORAL~TELMISARTAN~ZYDUS PHARMS USA INC~20MG~A~203325~001~AB~Au
g 26, 2014~No~RX~ZYDUS PHARMACEUTICALS USA INC
AMLODIPINE BESYLATE; TELMISARTAN~TABLET;ORAL~TELMISARTAN AND AMLODIPINE~LUPIN LT
D~EQ 5MG BASE;40MG~A~201586~001~AB~Jan 8, 2014~No~RX~LUPIN LTD
AMLODIPINE BESYLATE; TELMISARTAN~TABLET;ORAL~TELMISARTAN AND AMLODIPINE~MYLAN PH
ARMS INC~EQ 5MG BASE;40MG~A~202516~001~AB~Aug 26, 2014~No~RX~MYLAN PHARMACEUTICA
LS INC
ARMS INC~EQ 5MG BASE;80MG~A~202516~003~AB~Aug 26, 2014~No~RX~MYLAN PHARMACEUTICA
LS INC
ARMS INC~EQ 10MG BASE;40MG~A~202516~002~AB~Aug 26, 2014~No~RX~MYLAN PHARMACEUTIC
ALS INC
ARMS INC~EQ 10MG BASE;80MG~A~202516~004~AB~Aug 26, 2014~No~RX~MYLAN PHARMACEUTIC
ALS INC
AMLODIPINE BESYLATE; TELMISARTAN~TABLET;ORAL~TELMISARTAN AND AMLODIPINE~TORRENT
PHARMS LTD~EQ 5MG BASE;40MG~A~202517~001~AB~Jan 8, 2014~No~RX~TORRENT PHARMACEUT
ICALS LTD
PHARMS LTD~EQ 5MG BASE;80MG~A~202517~003~AB~Jan 8, 2014~No~RX~TORRENT PHARMACEUT
ICALS LTD
PHARMS LTD~EQ 10MG BASE;40MG~A~202517~002~AB~Jan 8, 2014~No~RX~TORRENT PHARMACEU
TICALS LTD
PHARMS LTD~EQ 10MG BASE;80MG~A~202517~004~AB~Jan 8, 2014~No~RX~TORRENT PHARMACEU
TICALS LTD
HYDROCHLOROTHIAZIDE; TELMISARTAN~TABLET;ORAL~TELMISARTAN AND HYDROCHLOROTHIAZIDE
~ALEMBIC PHARMS LTD~12.5MG;40MG~A~203010~001~AB~Feb 25, 2014~No~RX~ALEMBIC PHARM
ACEUTICALS LTD
~ALEMBIC PHARMS LTD~12.5MG;80MG~A~203010~002~AB~Feb 25, 2014~No~RX~ALEMBIC PHARM
ACEUTICALS LTD
~ALEMBIC PHARMS LTD~25MG;80MG~A~203010~003~AB~Feb 25, 2014~No~RX~ALEMBIC PHARMAC
EUTICALS LTD
~LUPIN LTD~12.5MG;40MG~A~091351~001~AB~Aug 7, 2014~No~RX~LUPIN LTD
~LUPIN LTD~12.5MG;80MG~A~091351~002~AB~Aug 7, 2014~No~RX~LUPIN LTD
~LUPIN LTD~25MG;80MG~A~091351~003~AB~Aug 7, 2014~No~RX~LUPIN LTD
~MYLAN PHARMS INC~12.5MG;40MG~A~091648~001~AB~Feb 25, 2014~No~RX~MYLAN PHARMACEU
TICALS INC
~MYLAN PHARMS INC~12.5MG;80MG~A~091648~002~AB~Feb 25, 2014~No~RX~MYLAN PHARMACEU
TICALS INC
~MYLAN PHARMS INC~25MG;80MG~A~091648~003~AB~Feb 25, 2014~No~RX~MYLAN PHARMACEUTI
CALS INC
~TORRENT PHARMS LTD~12.5MG;40MG~A~201192~001~AB~Feb 25, 2014~No~RX~TORRENT PHARM
ACEUTICALS LTD
~TORRENT PHARMS LTD~12.5MG;80MG~A~201192~002~AB~Feb 25, 2014~No~RX~TORRENT PHARM
ACEUTICALS LTD
~TORRENT PHARMS LTD~25MG;80MG~A~201192~003~AB~Feb 25, 2014~No~RX~TORRENT PHARMAC
EUTICALS LTD
TRIMEPRAZINE TARTRATE~TABLET;ORAL~TEMARIL~ALLERGAN HERBERT~EQ 2.5MG BASE~N~01131
6~001~~Approved Prior to Jan 1, 1982~No~DISCN~ALLERGAN HERBERT SKIN CARE DIV ALL
ERGAN INC
BETHANIDINE SULFATE~TABLET;ORAL~TENATHAN~ROBINS AH~10MG~N~017675~001~~Approved P
rior to Jan 1, 1982~No~DISCN~AH ROBINS CO
BETHANIDINE SULFATE~TABLET;ORAL~TENATHAN~ROBINS AH~25MG~N~017675~002~~Approved P
rior to Jan 1, 1982~No~DISCN~AH ROBINS CO
GUANFACINE HYDROCHLORIDE~TABLET;ORAL~TENEX~PROMIUS PHARMA~EQ 1MG BASE~N~019032~0
01~AB~Oct 27, 1986~No~RX~PROMIUS PHARMA LLC
02~AB~Nov 7, 1988~Yes~RX~PROMIUS PHARMA LLC
03~~Nov 7, 1988~No~DISCN~PROMIUS PHARMA LLC
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~TENORETIC 100~ALVOGEN IPCO SARL~100MG;25MG~
N~018760~001~AB~Jun 8, 1984~Yes~RX~ALVOGEN IPCO SARL
ATENOLOL; CHLORTHALIDONE~TABLET;ORAL~TENORETIC 50~ALVOGEN IPCO SARL~50MG;25MG~N~
018760~002~AB~Jun 8, 1984~No~RX~ALVOGEN IPCO SARL
ATENOLOL~TABLET;ORAL~TENORMIN~ALVOGEN IPCO SARL~25MG~N~018240~004~AB~Apr 9, 1990
~No~RX~ALVOGEN IPCO SARL
ATENOLOL~TABLET;ORAL~TENORMIN~ALVOGEN IPCO SARL~50MG~N~018240~001~AB~Approved Pr
ior to Jan 1, 1982~No~RX~ALVOGEN IPCO SARL
ATENOLOL~TABLET;ORAL~TENORMIN~ALVOGEN IPCO SARL~100MG~N~018240~002~AB~Approved P
rior to Jan 1, 1982~Yes~RX~ALVOGEN IPCO SARL
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~TENUATE~SANOFI AVENTIS US~25MG~N~017668
~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~TENUATE~WATSON PHARMS~25MG~N~011722~002
~AA~Approved Prior to Jan 1, 1982~Yes~RX~WATSON PHARMACEUTICALS
DIETHYLPROPION HYDROCHLORIDE~TABLET;ORAL~TEPANIL~3M~25MG~N~011673~001~~Approved
Prior to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
TERAZOSIN HYDROCHLORIDE~TABLET;ORAL~TERAZOSIN HYDROCHLORIDE~IVAX SUB TEVA PHARMS
~EQ 1MG BASE~A~074530~001~~Apr 21, 2000~No~DISCN~IVAX PHARMACEUTICALS INC SUB TE
~EQ 10MG BASE~A~074530~004~~Apr 21, 2000~No~DISCN~IVAX PHARMACEUTICALS INC SUB T
TERAZOSIN HYDROCHLORIDE~TABLET;ORAL~TERAZOSIN HYDROCHLORIDE~SANDOZ~EQ 1MG BASE~A
~074315~001~~Dec 31, 1998~No~DISCN~SANDOZ INC
~074657~001~~Apr 28, 2000~No~DISCN~SANDOZ INC

TERAZOSIN HYDROCHLORIDE~TABLET;ORAL~TERAZOSIN HYDROCHLORIDE~SANDOZ~EQ 10MG BASE~
TERAZOSIN HYDROCHLORIDE~TABLET;ORAL~TERAZOSIN HYDROCHLORIDE~SANDOZ~EQ 10MG BASE~
A~074657~004~~Apr 28, 2000~No~DISCN~SANDOZ INC
TERAZOSIN HYDROCHLORIDE~TABLET;ORAL~TERAZOSIN HYDROCHLORIDE~TEVA~EQ 1MG BASE~A~0
TERAZOSIN HYDROCHLORIDE~TABLET;ORAL~TERAZOSIN HYDROCHLORIDE~TEVA~EQ 10MG BASE~A~
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~APOTEX~EQ 250MG
BASE~A~078199~001~AB~Jul 2, 2007~No~RX~APOTEX CORP
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~AUROBINDO PHARMA
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~BRECKENRIDGE PHA
RM~EQ 250MG BASE~A~077714~001~AB~Jun 4, 2010~No~RX~BRECKENRIDGE PHARMACEUTICAL I
NC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~CIPLA LTD~EQ 250
MG BASE~A~077137~001~AB~Jul 2, 2007~No~RX~CIPLA LTD
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~DR REDDYS LABS I
NC~EQ 250MG BASE~A~076390~001~AB~Jul 2, 2007~No~RX~DR REDDYS LABORATORIES INC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~GEDEON RICHTER U
SA~EQ 250MG BASE~A~077065~001~~Jul 2, 2007~No~DISCN~GEDEON RICHTER USA INC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~GLENMARK GENERIC
S~EQ 250MG BASE~A~078157~001~AB~Jul 2, 2007~No~RX~GLENMARK GENERICS LTD
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~HARRIS PHARM~EQ
250MG BASE~A~077919~001~AB~Jul 2, 2007~No~RX~HARRIS PHARMACEUTICAL INC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~INVAGEN PHARMS~E
Q 250MG BASE~A~077533~001~AB~Jul 2, 2007~No~RX~INVAGEN PHARMACEUTICALS INC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~MYLAN~EQ 250MG B
ASE~A~077136~001~~Jul 2, 2007~No~DISCN~MYLAN PHARMACEUTICALS INC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~MYLAN~EQ 250MG B
ASE~A~077195~001~AB~Jul 2, 2007~No~RX~MYLAN PHARMACEUTICALS INC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~ORCHID HLTHCARE~
EQ 250MG BASE~A~078163~001~AB~Jul 2, 2007~No~RX~ORCHID HEALTHCARE
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~ROXANE~EQ 250MG
BASE~A~077223~001~~Jul 2, 2007~No~DISCN~ROXANE LABORATORIES INC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~TEVA~EQ 250MG BA
SE~A~076377~001~AB~Jul 2, 2007~No~RX~TEVA PHARMACEUTICALS USA INC
TERBINAFINE HYDROCHLORIDE~TABLET;ORAL~TERBINAFINE HYDROCHLORIDE~WOCKHARDT~EQ 250
MG BASE~A~078229~001~~Jul 2, 2007~No~DISCN~WOCKHARDT LTD
TERBUTALINE SULFATE~TABLET;ORAL~TERBUTALINE SULFATE~IMPAX LABS~2.5MG~A~075877~00
1~AB~Jun 26, 2001~No~RX~IMPAX LABORATORIES INC
TERBUTALINE SULFATE~TABLET;ORAL~TERBUTALINE SULFATE~IMPAX LABS~5MG~A~075877~002~
AB~Jun 26, 2001~Yes~RX~IMPAX LABORATORIES INC
TERBUTALINE SULFATE~TABLET;ORAL~TERBUTALINE SULFATE~LANNETT~2.5MG~A~077152~001~A
B~Mar 25, 2005~No~RX~LANNETT HOLDINGS INC
TERBUTALINE SULFATE~TABLET;ORAL~TERBUTALINE SULFATE~LANNETT~5MG~A~077152~002~AB~
Mar 25, 2005~No~RX~LANNETT HOLDINGS INC
TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)~TABLET;ORAL~TERF
ONYL~BRISTOL MYERS SQUIBB~167MG;167MG;167MG~N~006904~001~~Approved Prior to Jan
1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
CARBAMAZEPINE~TABLET;ORAL~TERIL~TARO~200MG~A~076525~001~~Sep 26, 2003~No~DISCN~T
OXYTETRACYCLINE~TABLET;ORAL~TERRAMYCIN~PFIZER~250MG~N~050287~001~~Approved Prior
to Jan 1, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
TESTOLACTONE~TABLET;ORAL~TESLAC~BRISTOL MYERS SQUIBB~50MG~N~016118~001~~Approved
TESTOLACTONE~TABLET;ORAL~TESLAC~BRISTOL MYERS SQUIBB~250MG~N~016118~002~~Approve
d Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
EPROSARTAN MESYLATE~TABLET;ORAL~TEVETEN~ABBVIE~EQ 300MG BASE~N~020738~004~~Dec 2
EPROSARTAN MESYLATE~TABLET;ORAL~TEVETEN~ABBVIE~EQ 400MG BASE~N~020738~005~AB~Dec
22, 1997~No~RX~ABBVIE INC
EPROSARTAN MESYLATE~TABLET;ORAL~TEVETEN~ABBVIE~EQ 600MG BASE~N~020738~006~AB~May
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~TEVETEN HCT~ABBVIE~600MG;12
.5MG~N~021268~001~~Nov 1, 2001~No~RX~ABBVIE INC
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~TEVETEN HCT~ABBVIE~600MG;25
MG~N~021268~002~~Nov 1, 2001~Yes~RX~ABBVIE INC
CHLORTHALIDONE~TABLET;ORAL~THALITONE~CITRON PHARMA LLC~15MG~N~019574~001~~Dec 20
, 1988~Yes~RX~CITRON PHARMA LLC
CHLORTHALIDONE~TABLET;ORAL~THALITONE~CITRON PHARMA LLC~25MG~N~019574~002~~Feb 12
, 1992~No~DISCN~CITRON PHARMA LLC
CHLORTHALIDONE~TABLET;ORAL~THALITONE~MONARCH PHARMS~25MG~A~088051~001~~Nov 12, 1
THEOPHYLLINE~TABLET;ORAL~THEOCLEAR-100~CENT PHARMS~100MG~A~085353~002~~Approved
Prior to Jan 1, 1982~No~DISCN~CENTRAL PHARMACEUTICALS INC
THEOPHYLLINE~TABLET;ORAL~THEOCLEAR-200~CENT PHARMS~200MG~A~085353~001~~Approved
Prior to Jan 1, 1982~No~DISCN~CENTRAL PHARMACEUTICALS INC
THEOPHYLLINE~TABLET;ORAL~THEOLAIR~MEDICIS~125MG~A~086399~001~~Approved Prior to
Jan 1, 1982~Yes~RX~MEDICIS PHARMACEUTICAL CORP
THEOPHYLLINE~TABLET;ORAL~THEOLAIR~MEDICIS~250MG~A~086399~002~~Approved Prior to
Jan 1, 1982~Yes~RX~MEDICIS PHARMACEUTICAL CORP
THEOPHYLLINE~TABLET;ORAL~THEOPHYL-225~ORTHO MCNEIL PHARM~225MG~A~084726~001~~App
roved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
THIOGUANINE~TABLET;ORAL~THIOGUANINE~ASPEN GLOBAL INC~40MG~N~012429~001~~Approved
Prior to Jan 1, 1982~Yes~RX~ASPEN GLOBAL INC
TIOPRONIN~TABLET;ORAL~THIOLA~MISSION PHARMA~100MG~N~019569~001~~Aug 11, 1988~Yes
~RX~MISSION PHARMACAL CO
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~ANI PHARMS INC
~10MG~A~088270~001~~Apr 14, 1983~No~DISCN~ANI PHARMACEUTICALS INC
~10MG~A~088493~001~~May 17, 1985~No~DISCN~ANI PHARMACEUTICALS INC
~100MG~A~088273~001~~Oct 3, 1983~No~DISCN~ANI PHARMACEUTICALS INC
~100MG~A~088456~001~~May 17, 1985~No~DISCN~ANI PHARMACEUTICALS INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~MUTUAL PHARM~1
0MG~A~088375~001~~Nov 18, 1983~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
0MG~A~089953~004~AB~Aug 1, 1986~No~RX~MUTUAL PHARMACEUTICAL CO INC

00MG~A~089953~001~AB~Oct 7, 1988~No~RX~MUTUAL PHARMACEUTICAL CO INC
50MG~A~088737~001~~Sep 26, 1984~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
00MG~A~088738~001~~Oct 16, 1984~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~MYLAN~10MG~A~0
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~MYLAN~100MG~A~
088004~001~AB~Nov 18, 1983~Yes~RX~MYLAN PHARMACEUTICALS INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~MYLAN~100MG~A~
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~PAR PHARM~10MG
~A~088351~001~~Dec 5, 1983~No~DISCN~PAR PHARMACEUTICAL INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~PAR PHARM~100M
G~A~088480~001~~Dec 29, 1983~No~DISCN~PAR PHARMACEUTICAL INC
G~A~089764~001~~Feb 9, 1988~No~DISCN~PAR PHARMACEUTICAL INC
G~A~089765~001~~Feb 9, 1988~No~DISCN~PAR PHARMACEUTICAL INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~ROXANE~10MG~A~
088663~001~~Mar 15, 1984~No~DISCN~ROXANE LABORATORIES INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~ROXANE~100MG~A
~089048~001~~Feb 26, 1985~No~DISCN~ROXANE LABORATORIES INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~SANDOZ~10MG~A~

THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~SANDOZ~100MG~A
~088135~001~~Nov 20, 1984~No~DISCN~SANDOZ INC
~088136~001~~Sep 17, 1986~No~DISCN~SANDOZ INC
~088137~001~~Sep 17, 1986~No~DISCN~SANDOZ INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~SUPERPHARM~10M
G~A~089103~001~~Jul 2, 1985~No~DISCN~SUPERPHARM CORP
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~WATSON LABS~10
MG~A~088412~001~~Sep 12, 1983~No~DISCN~WATSON LABORATORIES INC
MG~A~088476~001~~Nov 8, 1983~No~DISCN~WATSON LABORATORIES INC
MG~A~088561~001~~May 11, 1984~No~DISCN~WATSON LABORATORIES INC
MG~A~088345~001~~Jul 28, 1983~No~DISCN~WATSON LABORATORIES INC
0MG~A~088284~001~~Aug 25, 1983~No~DISCN~WATSON LABORATORIES INC
0MG~A~088564~001~~May 11, 1984~No~DISCN~WATSON LABORATORIES INC
0MG~A~088736~001~~Jul 24, 1984~No~DISCN~WATSON LABORATORIES INC
0MG~A~088869~001~~Jun 28, 1985~No~DISCN~WATSON LABORATORIES INC
0MG~A~088872~001~~Apr 26, 1985~No~DISCN~WATSON LABORATORIES INC
THIORIDAZINE HYDROCHLORIDE~TABLET;ORAL~THIORIDAZINE HYDROCHLORIDE~WEST WARD~10MG
~A~088658~001~~Mar 26, 1984~No~DISCN~WEST WARD PHARMACEUTICAL CORP

SULFAMETHIZOLE~TABLET;ORAL~THIOSULFIL~WYETH AYERST~250MG~N~008565~001~~Approved
SULFAMETHIZOLE~TABLET;ORAL~THIOSULFIL~WYETH AYERST~500MG~N~008565~004~~Approved
CHLORPROMAZINE HYDROCHLORIDE~TABLET;ORAL~THORAZINE~GLAXOSMITHKLINE~10MG~N~009149
POTASSIUM IODIDE~TABLET;ORAL~THYRO-BLOCK~MEDPOINTE PHARM HLC~130MG~N~018307~001~
THCARE INC
THYROGLOBULIN~TABLET;ORAL~THYROGLOBULIN~IMPAX LABS~64.8MG~A~080151~001~~Approved
LIOTRIX (T4;T3)~TABLET;ORAL~THYROLAR-0.25~FOREST LABS~0.0125MG;0.0031MG~N~016807
~001~~Approved Prior to Jan 1, 1982~No~RX~FOREST LABORATORIES INC
LIOTRIX (T4;T3)~TABLET;ORAL~THYROLAR-0.5~FOREST LABS~0.025MG;0.0063MG~N~016807~0
05~~Approved Prior to Jan 1, 1982~No~RX~FOREST LABORATORIES INC
LIOTRIX (T4;T3)~TABLET;ORAL~THYROLAR-1~FOREST LABS~0.05MG;0.0125MG~N~016807~004~
~Approved Prior to Jan 1, 1982~No~RX~FOREST LABORATORIES INC
LIOTRIX (T4;T3)~TABLET;ORAL~THYROLAR-2~FOREST LABS~0.1MG;0.025MG~N~016807~002~~A
pproved Prior to Jan 1, 1982~No~RX~FOREST LABORATORIES INC
~Approved Prior to Jan 1, 1982~Yes~RX~FOREST LABORATORIES INC
~Approved Prior to Jan 1, 1982~No~DISCN~FOREST LABORATORIES INC
POTASSIUM IODIDE~TABLET;ORAL~THYROSAFE~RECIP~65MG~A~076350~001~~Sep 10, 2002~Yes
~OTC~RECIP AB
TIAGABINE HYDROCHLORIDE~TABLET;ORAL~TIAGABINE HYDROCHLORIDE~SUN PHARM INDS~2MG~A
~077555~001~AB~Nov 4, 2011~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
TIAGABINE HYDROCHLORIDE~TABLET;ORAL~TIAGABINE HYDROCHLORIDE~SUN PHARM INDS~4MG~A
~077555~002~AB~Nov 4, 2011~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLID~ROCHE PALO~125MG~N~019979~001~~Mar
24, 1993~No~DISCN~ROCHE PALO ALTO LLC
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLID~ROCHE PALO~250MG~N~019979~002~~Oct
31, 1991~No~DISCN~ROCHE PALO ALTO LLC
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~ACTAVIS ELIZABET
H~250MG~A~075253~001~~Aug 20, 1999~No~DISCN~ACTAVIS ELIZABETH LLC
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~APOTEX~250MG~A~0
75089~001~AB~Jul 1, 1999~No~RX~APOTEX INC
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~MYLAN~250MG~A~07
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~MYLAN~250MG~A~07
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~SANDOZ~250MG~A~0
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~SANDOZ~250MG~A~0
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~SUN PHARM INDS I
NC~250MG~A~075526~001~AB~Sep 26, 2002~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~TEVA~250MG~A~075
149~001~AB~Aug 20, 1999~Yes~RX~TEVA PHARMACEUTICALS USA INC
TICLOPIDINE HYDROCHLORIDE~TABLET;ORAL~TICLOPIDINE HYDROCHLORIDE~WATSON LABS~250M

G~A~075309~001~~Apr 26, 2000~No~DISCN~WATSON LABORATORIES INC
HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE~TABLET;ORAL~TIMOLIDE 10-25~MERCK~25MG;10MG~
N~018061~001~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~MYLAN~5MG~A~072668~002~~Jun 8, 1990~
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~MYLAN~10MG~A~072668~003~~Jun 8, 1990
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~MYLAN~20MG~A~072668~001~~Jun 8, 1990
~Yes~RX~MYLAN PHARMACEUTICALS INC
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~QUANTUM PHARMICS~5MG~A~072466~001~~M
ay 19, 1989~No~DISCN~QUANTUM PHARMICS LTD
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~QUANTUM PHARMICS~10MG~A~072467~001~~
May 19, 1989~No~DISCN~QUANTUM PHARMICS LTD
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~QUANTUM PHARMICS~20MG~A~072468~001~~
May 19, 1989~No~DISCN~QUANTUM PHARMICS LTD
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~SANDOZ~5MG~A~072550~001~~Apr 13, 198
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~TEVA~5MG~A~072648~001~~Jun 16, 1993~
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~TEVA~10MG~A~072649~001~~Jun 16, 1993
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~TEVA~20MG~A~072650~001~~Jun 16, 1993
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~USL PHARMA~5MG~A~072001~001~~Apr 11,
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~USL PHARMA~10MG~A~072002~001~~Apr 11
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~USL PHARMA~20MG~A~072003~001~~Apr 11
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~WATSON LABS~5MG~A~072269~001~~Apr 11
TIMOLOL MALEATE~TABLET;ORAL~TIMOLOL MALEATE~WATSON LABS~5MG~A~072917~001~~Jul 31
ACETOPHENAZINE MALEATE~TABLET;ORAL~TINDAL~SCHERING~20MG~N~012254~002~~Approved P
rior to Jan 1, 1982~No~DISCN~SCHERING CORP SUB SCHERING PLOUGH CORP
TINIDAZOLE~TABLET;ORAL~TINDAMAX~MISSION PHARMA~250MG~N~021618~001~AB~May 17, 200
4~No~RX~MISSION PHARMACAL CO
TINIDAZOLE~TABLET;ORAL~TINDAMAX~MISSION PHARMA~500MG~N~021618~002~AB~May 17, 200
4~Yes~RX~MISSION PHARMACAL CO
TINIDAZOLE~TABLET;ORAL~TINIDAZOLE~NOVEL LABS INC~250MG~A~202044~001~AB~Apr 30, 2
TINIDAZOLE~TABLET;ORAL~TINIDAZOLE~NOVEL LABS INC~500MG~A~202044~002~AB~Apr 30, 2
TINIDAZOLE~TABLET;ORAL~TINIDAZOLE~ROXANE~250MG~A~201172~001~AB~Apr 30, 2012~No~R
TINIDAZOLE~TABLET;ORAL~TINIDAZOLE~ROXANE~500MG~A~201172~002~AB~Apr 30, 2012~No~R
TINIDAZOLE~TABLET;ORAL~TINIDAZOLE~UNIQUE PHARM LABS~250MG~A~202489~001~AB~Oct 9,

TINIDAZOLE~TABLET;ORAL~TINIDAZOLE~UNIQUE PHARM LABS~500MG~A~202489~002~AB~Oct 9,
DOLUTEGRAVIR SODIUM~TABLET;ORAL~TIVICAY~VIIV HLTHCARE~EQ 50MG BASE~N~204790~001~
~Aug 12, 2013~Yes~RX~VIIV HEALTHCARE CO
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~ACTAVIS ELIZABETH~
EQ 2MG BASE~A~076283~001~~Jul 12, 2002~No~DISCN~ACTAVIS ELIZABETH LLC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~ACTAVIS ELIZABETH~
EQ 4MG BASE~A~076283~002~~Jul 12, 2002~No~DISCN~ACTAVIS ELIZABETH LLC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~APOTEX~EQ 2MG BASE
~A~076533~001~AB~Jan 16, 2004~No~RX~APOTEX INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~APOTEX~EQ 4MG BASE
~A~076533~002~AB~Jan 16, 2004~No~RX~APOTEX INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~BARR~EQ 2MG BASE~A
~076371~001~~Apr 9, 2003~No~DISCN~BARR LABORATORIES INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~BARR~EQ 4MG BASE~A
~076371~002~~Apr 9, 2003~No~DISCN~BARR LABORATORIES INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~COREPHARMA~EQ 2MG
BASE~A~076347~001~AB~Oct 11, 2002~No~RX~COREPHARMA LLC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~COREPHARMA~EQ 4MG
BASE~A~076347~002~AB~Oct 11, 2002~No~RX~COREPHARMA LLC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~DR REDDYS LABS INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~DR REDDYS LABS INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~EQ 2MG BASE~A~076321~001~~Sep 30, 2004~No~DISCN~IVAX PHARMACEUTICALS INC SUB
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~IVAX SUB TEVA PHAR
MS~EQ 4MG BASE~A~076321~002~~Sep 30, 2004~No~DISCN~IVAX PHARMACEUTICALS INC SUB
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~MYLAN~EQ 2MG BASE~
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~MYLAN~EQ 4MG BASE~
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~MYLAN PHARMS INC~E
Q 2MG BASE~A~076282~001~~Dec 16, 2003~No~DISCN~MYLAN PHARMACEUTICALS INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~MYLAN PHARMS INC~E
Q 4MG BASE~A~076282~002~~Dec 16, 2003~No~DISCN~MYLAN PHARMACEUTICALS INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~PROSAM LABS~EQ 2MG
BASE~A~076281~001~AB~Oct 20, 2003~No~RX~PROSAM LABS LLC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~PROSAM LABS~EQ 4MG
BASE~A~076281~002~AB~Oct 20, 2003~No~RX~PROSAM LABS LLC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~SANDOZ INC~EQ 2MG
BASE~A~076280~001~AB~Nov 26, 2002~No~RX~SANDOZ INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~SANDOZ INC~EQ 4MG
BASE~A~076280~002~AB~Jun 27, 2002~No~RX~SANDOZ INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~SUN PHARM INDS INC
~EQ 2MG BASE~A~076416~001~AB~Sep 29, 2003~No~RX~SUN PHARMACEUTICAL INDUSTRIES IN
C
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~SUN PHARM INDS INC
~EQ 4MG BASE~A~076416~002~AB~Sep 29, 2003~No~RX~SUN PHARMACEUTICAL INDUSTRIES IN
C
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~TEVA~EQ 2MG BASE~A
~076284~001~AB~Jul 3, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~TEVA~EQ 4MG BASE~A
~076284~002~AB~Jul 3, 2002~No~RX~TEVA PHARMACEUTICALS USA INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~UNICHEM LABS LTD~E
Q 2MG BASE~A~091283~001~AB~Nov 28, 2012~No~RX~UNICHEM LABORATORIES LTD
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~TIZANIDINE HYDROCHLORIDE~UNICHEM LABS LTD~E

Q 4MG BASE~A~091283~002~AB~Nov 28, 2012~No~RX~UNICHEM LABORATORIES LTD
IMIPRAMINE HYDROCHLORIDE~TABLET;ORAL~TOFRANIL~MALLINCKRODT INC~10MG~A~087844~001
~AB~May 22, 1984~Yes~RX~MALLINCKRODT INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~BARR~100MG~A~070162~001~~Jan 14, 1986~No~DISCN
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~DURAMED PHARMS BARR~100MG~A~070165~001~~Jan 10
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~INTERPHARM~250MG~A~071270~001~~Sep 23, 1986~No
~DISCN~INTERPHARM INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~INTERPHARM~500MG~A~071271~001~~Sep 23, 1986~No
~DISCN~INTERPHARM INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~IVAX SUB TEVA PHARMS~100MG~N~018894~001~~Nov 2
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~MUTUAL PHARM~100MG~A~071357~001~~Jul 16, 1987~
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~MYLAN PHARMS INC~250MG~A~070259~001~~Jan 2, 19
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~MYLAN PHARMS INC~500MG~A~070259~003~~Mar 17, 1
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~PAR PHARM~100MG~A~070159~001~~Jan 6, 1986~No~D
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~SANDOZ~100MG~A~071633~001~~Dec 9, 1987~No~DISC
N~SANDOZ INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~SANDOZ~250MG~A~070289~001~~Mar 13, 1986~No~DIS
CN~SANDOZ INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~SANDOZ~500MG~A~070290~001~~Mar 13, 1986~No~DIS
CN~SANDOZ INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~SUPERPHARM~250MG~A~070763~001~~Jun 16, 1986~No
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~SUPERPHARM~500MG~A~070764~001~~Jun 16, 1986~No
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~USL PHARMA~100MG~A~071355~001~~Jan 11, 1988~No
~DISCN~USL PHARMA INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~USL PHARMA~250MG~A~070168~001~~Apr 2, 1986~No~
DISCN~USL PHARMA INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~USL PHARMA~500MG~A~070169~001~~Apr 2, 1986~No~

DISCN~USL PHARMA INC
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~WATSON LABS~100MG~A~070242~001~~Aug 1, 1986~No
TOLAZAMIDE~TABLET;ORAL~TOLAZAMIDE~WATSON LABS~100MG~A~070513~001~~Jan 9, 1986~No
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~ALRA~500MG~A~086141~001~~Approved Prior to J
an 1, 1982~No~DISCN~ALRA LABORATORIES INC
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~ASCOT~500MG~A~087541~001~~Mar 1, 1983~No~DIS
CN~ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~BARR~500MG~A~087121~001~~Approved Prior to J
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~DAVA PHARMS INC~500MG~A~086926~001~~Approved
Prior to Jan 1, 1982~No~DISCN~DAVA PHARMACEUTICALS INC
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~IVAX PHARMS~500MG~A~087093~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~MYLAN PHARMS INC~500MG~A~086445~001~~Approve
d Prior to Jan 1, 1982~Yes~RX~MYLAN PHARMACEUTICALS INC
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~PARKE DAVIS~500MG~A~086047~001~~Approved Pri
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~PUREPAC PHARM~500MG~A~088950~001~~Jun 17, 19
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~SANDOZ~500MG~A~086574~001~~Approved Prior to
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~SANDOZ~500MG~N~012678~001~~Approved Prior to
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~SUPERPHARM~500MG~A~088893~001~~Nov 19, 1984~
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~VANGARD~500MG~A~087876~001~~Apr 20, 1982~No~
DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~WATSON LABS~250MG~A~089110~001~~May 29, 1987
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~WATSON LABS~500MG~A~086109~001~~Approved Pri
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~WATSON LABS~500MG~A~087318~001~~Approved Pri
TOLBUTAMIDE~TABLET;ORAL~TOLBUTAMIDE~WATSON LABS~500MG~A~089111~001~~May 29, 1987
TOLMETIN SODIUM~TABLET;ORAL~TOLECTIN~ORTHO MCNEIL JANSSEN~EQ 200MG BASE~N~017628
~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL JANSSEN PHARMACEUTICAL
S INC
TOLMETIN SODIUM~TABLET;ORAL~TOLECTIN 600~ORTHO MCNEIL JANSSEN~EQ 600MG BASE~N~01
7628~002~~Mar 8, 1989~No~DISCN~ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
TOLAZAMIDE~TABLET;ORAL~TOLINASE~PHARMACIA AND UPJOHN~100MG **Federal Register de
y reasons**~N~015500~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND U
PJOHN CO
TOLAZAMIDE~TABLET;ORAL~TOLINASE~PHARMACIA AND UPJOHN~250MG~N~015500~004~~Approve
TOLAZAMIDE~TABLET;ORAL~TOLINASE~PHARMACIA AND UPJOHN~500MG~N~015500~005~~Approve
TOLMETIN SODIUM~TABLET;ORAL~TOLMETIN SODIUM~ACTAVIS ELIZABETH~EQ 600MG BASE~A~07
3527~001~~Jun 30, 1992~No~DISCN~ACTAVIS ELIZABETH LLC

TOLMETIN SODIUM~TABLET;ORAL~TOLMETIN SODIUM~IVAX SUB TEVA PHARMS~EQ 600MG BASE~A
CALS USA
TOLMETIN SODIUM~TABLET;ORAL~TOLMETIN SODIUM~MUTUAL PHARM~EQ 200MG BASE~A~073310~
TOLMETIN SODIUM~TABLET;ORAL~TOLMETIN SODIUM~MYLAN~EQ 600MG BASE~A~074473~001~AB~
Aug 30, 1994~Yes~RX~MYLAN PHARMACEUTICALS INC
TOLMETIN SODIUM~TABLET;ORAL~TOLMETIN SODIUM~SANDOZ~EQ 200MG BASE~A~073588~001~~J
ul 31, 1992~No~DISCN~SANDOZ INC
TOLMETIN SODIUM~TABLET;ORAL~TOLMETIN SODIUM~SANDOZ~EQ 600MG BASE~A~074002~001~~S
ep 27, 1993~No~DISCN~SANDOZ INC
TOLMETIN SODIUM~TABLET;ORAL~TOLMETIN SODIUM~TEVA~EQ 600MG BASE~A~074729~001~~Feb
TOLTERODINE TARTRATE~TABLET;ORAL~TOLTERODINE TARTRATE~APOTEX CORP~1MG~A~200164~0
01~AB~Sep 25, 2012~No~RX~APOTEX CORP
TOLTERODINE TARTRATE~TABLET;ORAL~TOLTERODINE TARTRATE~APOTEX CORP~2MG~A~200164~0
02~AB~Sep 25, 2012~No~RX~APOTEX CORP
TOLTERODINE TARTRATE~TABLET;ORAL~TOLTERODINE TARTRATE~IVAX SUB TEVA PHARMS~1MG~A
~077006~001~AB~Feb 23, 2015~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTIC
ALS USA
TOLTERODINE TARTRATE~TABLET;ORAL~TOLTERODINE TARTRATE~IVAX SUB TEVA PHARMS~2MG~A
~077006~002~AB~Feb 23, 2015~No~RX~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTIC
ALS USA
TOLTERODINE TARTRATE~TABLET;ORAL~TOLTERODINE TARTRATE~MYLAN PHARMS INC~1MG~A~202
TOLTERODINE TARTRATE~TABLET;ORAL~TOLTERODINE TARTRATE~MYLAN PHARMS INC~2MG~A~202
TOCAINIDE HYDROCHLORIDE~TABLET;ORAL~TONOCARD~ASTRAZENECA~400MG~N~018257~001~~Nov
TOCAINIDE HYDROCHLORIDE~TABLET;ORAL~TONOCARD~ASTRAZENECA~600MG~N~018257~002~~Nov
TOPIRAMATE~TABLET;ORAL~TOPAMAX~JANSSEN PHARMS~25MG~N~020505~004~AB~Dec 24, 1996~
No~RX~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~TABLET;ORAL~TOPAMAX~JANSSEN PHARMS~50MG~N~020505~005~AB~Dec 24, 1996~
No~RX~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~TABLET;ORAL~TOPAMAX~JANSSEN PHARMS~100MG~N~020505~001~AB~Dec 24, 1996
~Yes~RX~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~TABLET;ORAL~TOPAMAX~JANSSEN PHARMS~200MG~N~020505~002~AB~Dec 24, 1996
~No~RX~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~TABLET;ORAL~TOPAMAX~JANSSEN PHARMS~300MG~N~020505~003~~Dec 24, 1996~N
o~DISCN~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~TABLET;ORAL~TOPAMAX~JANSSEN PHARMS~400MG~N~020505~006~~Dec 24, 1996~N
o~DISCN~JANSSEN PHARMACEUTICALS INC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ACCORD HLTHCARE~25MG~A~076311~001~AB~Mar 27, 2
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ACCORD HLTHCARE~50MG~A~076311~002~AB~Mar 27, 2
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ACCORD HLTHCARE~100MG~A~076311~003~AB~Mar 27,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ACCORD HLTHCARE~200MG~A~076311~004~AB~Mar 27,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ACTIVIS TOTOWA LLC~25MG~A~078637~001~AB~Feb 27
, 2013~No~RX~ACTIVIS TOTOWA LLC
, 2013~No~RX~ACTIVIS TOTOWA LLC
7, 2013~No~RX~ACTIVIS TOTOWA LLC
7, 2013~No~RX~ACTIVIS TOTOWA LLC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~APOTEX INC~25MG~A~077733~001~AB~Mar 27, 2009~N

TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~APOTEX INC~50MG~A~077733~002~AB~Mar 27, 2009~N
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~APOTEX INC~100MG~A~077733~003~AB~Mar 27, 2009~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~APOTEX INC~200MG~A~077733~004~AB~Mar 27, 2009~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~AUROBINDO PHARMA~25MG~A~078462~001~AB~Mar 27,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~BARR~25MG~A~076315~001~~Mar 27, 2009~No~DISCN~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~BARR~100MG~A~076315~002~~Mar 27, 2009~No~DISCN
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~BARR~200MG~A~076315~003~~Mar 27, 2009~No~DISCN
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~CIPLA LTD~25MG~A~076343~001~AB~Mar 27, 2009~No
~RX~CIPLA LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~CIPLA LTD~50MG~A~076343~002~AB~Mar 27, 2009~No
~RX~CIPLA LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~CIPLA LTD~100MG~A~076343~003~AB~Mar 27, 2009~N
o~RX~CIPLA LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~CIPLA LTD~200MG~A~076343~004~AB~Mar 27, 2009~N
o~RX~CIPLA LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~GLENMARK GENERICS~25MG~A~077627~001~AB~Mar 27,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~GLENMARK GENERICS~50MG~A~077627~002~AB~Mar 27,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~GLENMARK GENERICS~100MG~A~077627~003~AB~Mar 27
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~GLENMARK GENERICS~200MG~A~077627~004~AB~Mar 27
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~INVAGEN PHARMS~25MG~A~079162~001~AB~Mar 27, 20
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~LUPIN~25MG~A~078410~001~AB~Sep 11, 2013~No~RX~
LUPIN LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~LUPIN~50MG~A~078410~002~AB~Sep 11, 2013~No~RX~
LUPIN LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~LUPIN~100MG~A~078410~003~AB~Sep 11, 2013~No~RX
~LUPIN LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~LUPIN~200MG~A~078410~004~AB~Sep 11, 2013~No~RX
~LUPIN LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~MYLAN~25MG~A~076314~001~AB~Mar 27, 2009~No~RX~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~MYLAN~50MG~A~076314~002~AB~Mar 27, 2009~No~RX~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~MYLAN~100MG~A~076314~003~AB~Mar 27, 2009~No~RX
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~MYLAN~200MG~A~076314~004~AB~Mar 27, 2009~No~RX

TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~PLIVA HRVATSKA DOO~25MG~A~077905~001~~Mar 30,
2009~No~DISCN~PLIVA HRVATSKA DOO
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~RANBAXY~25MG~A~076327~001~AB~Mar 27, 2009~No~R
X~RANBAXY LABORATORIES LTD
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~RANBAXY~100MG~A~076327~002~AB~Mar 27, 2009~No~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~RANBAXY~200MG~A~076327~003~AB~Mar 27, 2009~No~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ROXANE~25MG~A~076306~001~~Mar 27, 2009~No~DISC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ROXANE~50MG~A~076306~002~~Mar 27, 2009~No~DISC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ROXANE~100MG~A~076306~003~~Mar 27, 2009~No~DIS
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ROXANE~200MG~A~076306~004~~Mar 27, 2009~No~DIS
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~SUN PHARMA GLOBAL~25MG~A~090278~001~AB~Mar 27,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~SUN PHARMA GLOBAL~50MG~A~090278~002~AB~Mar 27,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~SUN PHARMA GLOBAL~100MG~A~090278~003~AB~Mar 27
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~SUN PHARMA GLOBAL~200MG~A~090278~004~AB~Mar 27
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~TEVA~25MG~A~076317~001~AB~Mar 27, 2009~No~RX~T
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~TEVA~50MG~A~076317~002~AB~Mar 27, 2009~No~RX~T
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~TEVA~100MG~A~076317~003~AB~Mar 27, 2009~No~RX~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~TEVA~200MG~A~076317~004~AB~Mar 27, 2009~No~RX~
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~TORRENT PHARMS~25MG~A~079153~001~AB~Mar 27, 20
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~UNICHEM LABS LTD~25MG~A~090162~001~AB~Mar 27,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~UNICHEM LABS LTD~200MG~A~090162~004~AB~Feb 19,
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~UPSHER SMITH~25MG~A~078499~001~AB~Jan 7, 2010~
No~RX~UPSHER SMITH LABORATORIES INC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~UPSHER SMITH~50MG~A~078499~002~AB~Jan 7, 2010~
No~RX~UPSHER SMITH LABORATORIES INC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~UPSHER SMITH~100MG~A~078499~003~AB~Jan 7, 2010

~No~RX~UPSHER SMITH LABORATORIES INC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~UPSHER SMITH~200MG~A~078499~004~AB~Jan 7, 2010
~No~RX~UPSHER SMITH LABORATORIES INC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~WATSON LABS~25MG~A~077643~001~~Mar 27, 2009~No
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~WATSON LABS~50MG~A~077643~002~~Mar 27, 2009~No
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~WATSON LABS~100MG~A~077643~003~~Mar 27, 2009~N
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~WATSON LABS~200MG~A~077643~004~~Mar 27, 2009~N
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~WOCKHARDT USA~25MG~A~090353~001~AB~Sep 1, 2010
~No~RX~WOCKHARDT USA LLC
~No~RX~WOCKHARDT USA LLC
0~No~RX~WOCKHARDT USA LLC
0~No~RX~WOCKHARDT USA LLC
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE~ZYDUS PHARMS USA INC~25MG~A~078235~001~AB~Mar
TOPIRAMATE~TABLET;ORAL~TOPIRAMATE ~HIKMA PHARMS~25MG~A~091185~001~AB~Nov 25, 201
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~TORA~SOLVAY~8MG~A~084035~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~SOLVAY PHARMACEUTICALS
KETOROLAC TROMETHAMINE~TABLET;ORAL~TORADOL~ROCHE PALO~10MG~N~019645~001~~Dec 20,
1991~No~DISCN~ROCHE PALO ALTO LLC
THIETHYLPERAZINE MALEATE~TABLET;ORAL~TORECAN~NOVARTIS~10MG~N~012753~001~~Approve
TORSEMIDE~TABLET;ORAL~TORSEMIDE~APOTEX INC~5MG~A~076894~001~AB~May 31, 2005~No~R
X~APOTEX INC ETOBICOKE SITE
TORSEMIDE~TABLET;ORAL~TORSEMIDE~APOTEX INC~10MG~A~076894~002~AB~May 31, 2005~No~
TORSEMIDE~TABLET;ORAL~TORSEMIDE~APOTEX INC~20MG~A~076894~003~AB~May 31, 2005~No~
TORSEMIDE~TABLET;ORAL~TORSEMIDE~APOTEX INC~100MG~A~076894~004~AB~May 31, 2005~No
TORSEMIDE~TABLET;ORAL~TORSEMIDE~AUROBINDO PHARMA~5MG~A~078249~001~AB~Oct 17, 200
TORSEMIDE~TABLET;ORAL~TORSEMIDE~HETERO LABS LTD III~5MG~A~079234~001~AB~Jan 27,
2009~No~RX~HETERO LABS LTD UNIT III

TORSEMIDE~TABLET;ORAL~TORSEMIDE~HETERO LABS LTD III~100MG~A~079234~004~AB~Jan 27
TORSEMIDE~TABLET;ORAL~TORSEMIDE~PAR PHARM~5MG~A~076226~001~AB~May 27, 2003~No~RX
TORSEMIDE~TABLET;ORAL~TORSEMIDE~PAR PHARM~10MG~A~076226~002~AB~May 27, 2003~No~R
TORSEMIDE~TABLET;ORAL~TORSEMIDE~PAR PHARM~20MG~A~076226~003~AB~May 27, 2003~No~R
TORSEMIDE~TABLET;ORAL~TORSEMIDE~PAR PHARM~100MG~A~076226~004~AB~May 27, 2003~No~
RX~PAR PHARMACEUTICAL INC
TORSEMIDE~TABLET;ORAL~TORSEMIDE~PLIVA PHARM IND~5MG~A~076346~001~AB~May 30, 2003
~No~RX~PLIVA PHARMACEUTICAL INDUSTRY INC
3~No~RX~PLIVA PHARMACEUTICAL INDUSTRY INC
TORSEMIDE~TABLET;ORAL~TORSEMIDE~PLIVA PHARM IND~100MG~A~076346~004~AB~Oct 19, 20
TORSEMIDE~TABLET;ORAL~TORSEMIDE~ROXANE~5MG~A~076943~001~AB~Mar 1, 2005~No~RX~ROX
TORSEMIDE~TABLET;ORAL~TORSEMIDE~ROXANE~10MG~A~076943~002~AB~Mar 1, 2005~No~RX~RO
TORSEMIDE~TABLET;ORAL~TORSEMIDE~ROXANE~20MG~A~076943~003~AB~Mar 1, 2005~No~RX~RO
TORSEMIDE~TABLET;ORAL~TORSEMIDE~SUN PHARM INDS~5MG~A~078478~001~AB~Feb 26, 2008~
No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
TORSEMIDE~TABLET;ORAL~TORSEMIDE~SUN PHARM INDS~10MG~A~078478~002~AB~Feb 26, 2008
~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
~No~RX~SUN PHARMACEUTICAL INDUSTRIES LTD
TORSEMIDE~TABLET;ORAL~TORSEMIDE~TEVA~5MG~A~076110~001~AB~May 14, 2002~No~RX~TEVA
TORSEMIDE~TABLET;ORAL~TORSEMIDE~TEVA~10MG~A~076110~002~AB~May 14, 2002~No~RX~TEV
TORSEMIDE~TABLET;ORAL~TORSEMIDE~TEVA~20MG~A~076110~003~AB~May 14, 2002~No~RX~TEV
TORSEMIDE~TABLET;ORAL~TORSEMIDE~TEVA~100MG~A~076110~004~AB~May 14, 2002~No~RX~TE
TORSEMIDE~TABLET;ORAL~TORSEMIDE~VINTAGE PHARMS~5MG~A~090613~001~AB~Mar 22, 2011~
TORSEMIDE~TABLET;ORAL~TORSEMIDE~VINTAGE PHARMS~10MG~A~090613~002~AB~Mar 22, 2011
BOSENTAN~TABLET;ORAL~TRACLEER~ACTELION PHARMS LTD~62.5MG~N~021290~001~~Nov 20, 2
001~No~RX~ACTELION PHARMACEUTICALS LTD
BOSENTAN~TABLET;ORAL~TRACLEER~ACTELION PHARMS LTD~125MG~N~021290~002~~Nov 20, 20
LINAGLIPTIN~TABLET;ORAL~TRADJENTA~BOEHRINGER INGELHEIM~5MG~N~201280~001~~May 2,
HEXOCYCLIUM METHYLSULFATE~TABLET;ORAL~TRAL~ABBVIE~25MG~N~010599~001~~Approved Pr
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~ACCORD HLTHCARE INC~50

MG~A~202390~001~AB~May 16, 2013~No~RX~ACCORD HEALTHCARE INC USA
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~ACTAVIS ELIZABETH~50MG
~A~075960~001~~Jun 19, 2002~No~DISCN~ACTAVIS ELIZABETH LLC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~ALLIED PHARMA INC~50MG
~A~202075~001~AB~Nov 28, 2011~No~RX~ALLIED PHARMA INC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~AMNEAL PHARMS~50MG~A~0
76003~001~AB~Jun 20, 2002~No~RX~AMNEAL PHARMACEUTICALS LLC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~APOTEX~50MG~A~075981~0
01~AB~Jul 10, 2002~No~RX~APOTEX INC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~ASTA~50MG~A~075974~001
~~Jul 12, 2002~No~DISCN~ASTA MEDICA INC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~AUROBINDO PHARMA LTD~5
0MG~A~203494~001~AB~Mar 31, 2014~No~RX~AUROBINDO PHARMA LTD
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~CSPC OUYI PHARM CO~50M
G~A~091498~001~AB~Mar 29, 2013~No~RX~CSPC OUYI PHARMACEUTICAL CO LTD
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~IPCA LABS LTD~50MG~A~2
01973~001~AB~Nov 16, 2012~No~RX~IPCA LABORATORIES LTD
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~IVAX SUB TEVA PHARMS~5
0MG~A~075963~001~~Jul 3, 2002~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMAC
EUTICALS USA
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~MALLINCKRODT~50MG~A~07
5983~001~AB~Jun 25, 2002~No~RX~MALLINCKRODT INC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~MUTUAL PHARM~50MG~A~07
6100~001~AB~Jun 20, 2002~No~RX~MUTUAL PHARMACEUTICAL CO INC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~MYLAN~50MG~A~075986~00
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~MYLAN PHARMS INC~50MG~
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~NORTHSTAR HLTHCARE~50M
G~A~078935~001~AB~May 26, 2010~No~RX~NORTHSTAR HEALTHCARE HOLDINGS LTD
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~PLIVA~50MG~A~075982~00
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~SANDOZ~50MG~A~075968~0
01~~Jun 25, 2002~No~DISCN~SANDOZ
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~SUN PHARM INDS INC~50M
G~A~075964~001~AB~Jun 19, 2002~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~TEVA~50MG~A~075977~001
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~WATSON LABS~50MG~A~075
962~001~~Jun 24, 2002~No~DISCN~WATSON LABORATORIES
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE~ZYDUS PHARMS USA INC~5
0MG~A~090404~001~AB~Jan 31, 2011~No~RX~ZYDUS PHARMACEUTICALS USA INC
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE~TABLET;ORAL~TRAMADOL HYDROCHLORIDE AND ACE
TAMINOPHEN~ALLIED PHARMA INC~325MG;37.5MG~A~202076~001~AB~Mar 30, 2012~No~RX~ALL
IED PHARMA INC
TAMINOPHEN~AMNEAL PHARMS~325MG;37.5MG~A~090485~001~AB~Dec 9, 2009~No~RX~AMNEAL P
HARMACEUTICALS
TAMINOPHEN~APOTEX INC~325MG;37.5MG~A~078778~001~AB~Apr 7, 2014~No~RX~APOTEX INC
TAMINOPHEN~MICRO LABS LTD INDIA~325MG;37.5MG~A~201952~001~AB~Dec 14, 2012~No~RX~
MICRO LABS LTD INDIA
TAMINOPHEN~MYLAN~325MG;37.5MG~A~077858~001~AB~Sep 26, 2008~No~RX~MYLAN PHARMACEU
TICALS INC
TAMINOPHEN~PAR PHARM~325MG;37.5MG~A~076475~001~AB~Apr 21, 2005~No~RX~PAR PHARMAC
EUTICAL INC

TAMINOPHEN~SUN PHARM INDS INC~325MG;37.5MG~A~077184~001~AB~Dec 16, 2005~No~RX~SU
N PHARMACEUTICAL INDUSTRIES INC
TAMINOPHEN~WATSON LABS~325MG;37.5MG~A~076914~001~~Jul 26, 2006~No~DISCN~WATSON L
ABORATORIES INC
TAMINOPHEN~ZYDUS PHARMS USA INC~325MG;37.5MG~A~090460~001~AB~Sep 6, 2012~No~RX~Z
YDUS PHARMACEUTICALS USA INC
CHLORMEZANONE~TABLET;ORAL~TRANCOPAL~SANOFI AVENTIS US~100MG~N~011467~003~~Approv
CHLORMEZANONE~TABLET;ORAL~TRANCOPAL~SANOFI AVENTIS US~200MG~N~011467~005~~Approv
LABETALOL HYDROCHLORIDE~TABLET;ORAL~TRANDATE~CNTY LINE PHARMS~100MG~N~018716~001
~AB~May 24, 1985~No~RX~COUNTY LINE PHARMACEUTICALS LLC
~AB~Aug 1, 1984~No~RX~COUNTY LINE PHARMACEUTICALS LLC
~AB~Aug 1, 1984~No~RX~COUNTY LINE PHARMACEUTICALS LLC
~~Aug 1, 1984~No~DISCN~COUNTY LINE PHARMACEUTICALS LLC
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE~TABLET;ORAL~TRANDATE HCT~GLAXOSMITH
KLINE~25MG;100MG~N~019174~001~~Apr 10, 1987~No~DISCN~GLAXOSMITHKLINE
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~AUROBINDO PHARMA~1MG~A~078438~001~AB~Jun 1
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~CIPLA~1MG~A~077307~002~~Jun 12, 2007~No~DI
SCN~CIPLA LTD
SCN~CIPLA LTD
SCN~CIPLA LTD
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~COREPHARMA~1MG~A~077256~001~~Jun 12, 2007~
No~DISCN~COREPHARMA LLC
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~DR REDDYS LABS LTD~1MG~A~078493~001~~Aug 2
5, 2008~No~DISCN~DR REDDYS LABORATORIES LTD
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~EPIC PHARMA~1MG~A~078508~003~AB~Jun 18, 20
08~No~RX~EPIC PHARMA LLC
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~INVAGEN PHARMS~1MG~A~078320~001~AB~Jun 12,

TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~LUPIN~1MG~A~077522~001~AB~Jun 12, 2007~No~
RX~LUPIN LTD
RX~LUPIN LTD
RX~LUPIN LTD
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~MYLAN~1MG~A~078346~001~AB~Apr 28, 2008~No~
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~TEVA PHARMS~1MG~A~077489~001~AB~Dec 12, 20
TRANDOLAPRIL~TABLET;ORAL~TRANDOLAPRIL~WATSON LABS~1MG~A~077805~001~AB~Jun 12, 20
TRANEXAMIC ACID~TABLET;ORAL~TRANEXAMIC ACID~ACTAVIS LABS FL INC~650MG~A~202093~0
01~AB~Dec 27, 2012~No~RX~ACTAVIS LABORATORIES FL INC
TRANEXAMIC ACID~TABLET;ORAL~TRANEXAMIC ACID~APOTEX INC~650MG~A~202286~001~AB~Jan
MEPROBAMATE~TABLET;ORAL~TRANMEP~SOLVAY~400MG~A~084369~001~~Approved Prior to Jan
MEPROBAMATE~TABLET;ORAL~TRANMEP~SOLVAY~400MG~N~016249~001~~Approved Prior to Jan
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~TRANXENE~RECORDATI RARE~3.75MG~N~017105~006~
AB~Approved Prior to Jan 1, 1982~No~RX~RECORDATI RARE DISEASES INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~TRANXENE~RECORDATI RARE~7.5MG~N~017105~007~A
B~Approved Prior to Jan 1, 1982~No~RX~RECORDATI RARE DISEASES INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~TRANXENE~RECORDATI RARE~15MG~N~017105~008~AB
~Approved Prior to Jan 1, 1982~Yes~RX~RECORDATI RARE DISEASES INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~TRANXENE SD~RECORDATI RARE~11.25MG~N~017105~
005~~Approved Prior to Jan 1, 1982~No~DISCN~RECORDATI RARE DISEASES INC
CLORAZEPATE DIPOTASSIUM~TABLET;ORAL~TRANXENE SD~RECORDATI RARE~22.5MG~N~017105~0
04~~Approved Prior to Jan 1, 1982~No~DISCN~RECORDATI RARE DISEASES INC
TRANYLCYPROMINE SULFATE~TABLET;ORAL~TRANYLCYPROMINE SULFATE~PAR PHARM~EQ 10MG BA
SE~A~040640~001~AB~Jun 29, 2006~No~RX~PAR PHARMACEUTICAL INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~ALVOGEN~50MG~A~07163
6~001~AB~Apr 18, 1988~No~RX~ALVOGEN INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~ALVOGEN~100MG~A~0715
14~001~AB~Apr 18, 1988~No~RX~ALVOGEN INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~AM THERAP~50MG~A~071
139~001~~Oct 29, 1986~No~DISCN~AMERICAN THERAPEUTICS INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~AM THERAP~100MG~A~07
1140~001~~Oct 29, 1986~No~DISCN~AMERICAN THERAPEUTICS INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~APOTEX~50MG~A~071258
~001~AB~Mar 25, 1987~No~RX~APOTEX INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~APOTEX INC~100MG~A~0
71196~001~AB~Mar 25, 1987~Yes~RX~APOTEX INC

TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~MUTUAL PHARM~50MG~A~
073137~002~AB~Mar 24, 1993~No~RX~MUTUAL PHARMACEUTICAL CO INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~MUTUAL PHARM~100MG~A
~073137~001~AB~Mar 24, 1993~No~RX~MUTUAL PHARMACEUTICAL CO INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~MUTUAL PHARM~150MG~A
~073137~003~AB~Dec 22, 1995~No~RX~MUTUAL PHARMACEUTICAL CO INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~MYLAN~50MG~A~071405~
001~~Feb 27, 1991~No~DISCN~MYLAN PHARMACEUTICALS INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~MYLAN~100MG~A~071406
~001~~Feb 27, 1991~No~DISCN~MYLAN PHARMACEUTICALS INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~MYLAN PHARMS INC~50M
G~A~090514~001~AB~Jun 2, 2009~No~RX~MYLAN PHARMACEUTICALS INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~MYLAN PHARMS INC~100
MG~A~090514~002~AB~Jun 2, 2009~No~RX~MYLAN PHARMACEUTICALS INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~PLIVA~150MG~A~071525
~001~AB~Mar 9, 1988~No~RX~PLIVA INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~QUANTUM PHARMICS~100
MG~A~070921~001~~Dec 1, 1986~No~DISCN~QUANTUM PHARMICS LTD
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~SANDOZ~50MG~A~072484
~001~~Apr 30, 1990~No~DISCN~SANDOZ INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~SANDOZ~100MG~A~07248
3~001~~Apr 30, 1990~No~DISCN~SANDOZ INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~TEVA~150MG~A~074357~
001~~Apr 30, 1997~No~DISCN~TEVA PHARMACEUTICALS USA INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~TEVA PHARMS USA~50MG
~A~071523~001~AB~Dec 11, 1987~No~RX~TEVA PHARMACEUTICALS USA INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~TEVA PHARMS USA~100M
G~A~071524~001~AB~Dec 11, 1987~No~RX~TEVA PHARMACEUTICALS USA INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~TORRENT PHARMS LTD~5
0MG~A~202180~001~AB~Nov 27, 2013~No~RX~TORRENT PHARMACEUTICALS LTD
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~USL PHARMA~50MG~A~07
0491~001~~Apr 29, 1987~No~DISCN~USL PHARMA INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~USL PHARMA~100MG~A~0
70492~001~~Apr 29, 1987~No~DISCN~USL PHARMA INC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~VINTAGE~50MG~A~07219
2~001~AB~Feb 2, 1989~No~RX~VINTAGE PHARMACEUTICALS LLC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~VINTAGE~100MG~A~0721
93~001~AB~Feb 2, 1989~No~RX~VINTAGE PHARMACEUTICALS LLC
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~WATSON LABS~50MG~A~0
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~WATSON LABS~50MG~A~0
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~WATSON LABS~100MG~A~
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRAZODONE HYDROCHLORIDE~WATSON LABS~100MG~A~

ETHIONAMIDE~TABLET;ORAL~TRECATOR~WYETH PHARMS INC~250MG~N~013026~002~~Approved P
rior to Jan 1, 1982~Yes~RX~WYETH PHARMACEUTICALS INC
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TREMIN~SCHERING~2MG~A~080381~001~~Appr
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TREMIN~SCHERING~5MG~A~080381~003~~Appr
METHIXENE HYDROCHLORIDE~TABLET;ORAL~TREST~NOVARTIS~1MG~N~013420~001~~Approved Pr
METHOTREXATE SODIUM~TABLET;ORAL~TREXALL~BARR~EQ 5MG BASE~A~040385~001~~Mar 21, 2
METHOTREXATE SODIUM~TABLET;ORAL~TREXALL~BARR~EQ 7.5MG BASE~A~040385~002~~Mar 21,
METHOTREXATE SODIUM~TABLET;ORAL~TREXALL~BARR~EQ 10MG BASE~A~040385~003~~Mar 21,
METHOTREXATE SODIUM~TABLET;ORAL~TREXALL~BARR~EQ 15MG BASE~A~040385~004~~Mar 21,
2001~Yes~RX~BARR LABORATORIES INC
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE~TABLET;ORAL~TREXIMET~PERNIX IRELAND LTD~5
00MG;EQ 85MG BASE~N~021926~001~~Apr 15, 2008~Yes~RX~PERNIX IRELAND LTD
TRAZODONE HYDROCHLORIDE~TABLET;ORAL~TRIALODINE~QUANTUM PHARMICS~50MG~A~070942~00
1~~Dec 1, 1986~No~DISCN~QUANTUM PHARMICS LTD
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~BARR~2MG~A~084286~001~~Approved Prior to
Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~IMPAX LABS~4MG~A~084340~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~IVAX SUB TEVA PHARMS~4MG~A~083750~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMACE
UTICALS USA
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~MYLAN~2MG~A~084406~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~MYLAN PHARMACEUTICALS INC
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~PUREPAC PHARM~2MG~A~084020~002~~Approved
Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~PUREPAC PHARM~4MG~A~084020~003~~Approved
Prior to Jan 1, 1982~No~DISCN~PUREPAC PHARMACEUTICAL CO
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~ROXANE~2MG~A~084708~001~~Approved Prior
to Jan 1, 1982~No~DISCN~ROXANE LABORATORIES INC
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~SANDOZ~4MG~A~085601~001~~Approved Prior
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~TEVA~4MG~A~084775~001~~Approved Prior to
Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA INC
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~WATSON LABS~4MG~A~084270~001~~Approved P
TRIAMCINOLONE~TABLET;ORAL~TRIAMCINOLONE~WATSON LABS~4MG~A~085834~001~~Approved P
HYDROCHLOROTHIAZIDE; TRIAMTERENE~TABLET;ORAL~TRIAMTERENE AND HYDROCHLOROTHIAZIDE
~AM THERAP~50MG;75MG~A~072022~001~~Apr 17, 1988~No~DISCN~AMERICAN THERAPEUTICS I
NC
~APOTEX INC~25MG;37.5MG~A~071251~002~AB~May 5, 1998~No~RX~APOTEX INC
~APOTEX INC~50MG;75MG~A~071251~001~AB~Apr 17, 1988~No~RX~APOTEX INC
~PLIVA~25MG;37.5MG~A~074026~001~AB~Apr 26, 1996~No~RX~PLIVA INC
~PLIVA~50MG;75MG~A~073467~001~AB~Jan 31, 1996~No~RX~PLIVA INC
~QUANTUM PHARMICS~50MG;75MG~A~071980~001~~Apr 17, 1988~No~DISCN~QUANTUM PHARMICS
LTD
~SANDOZ~25MG;37.5MG~A~073281~001~AB~Apr 30, 1992~No~RX~SANDOZ INC
~SANDOZ~50MG;75MG~A~072011~001~AB~Jun 17, 1988~No~RX~SANDOZ INC
~WATSON LABS~25MG;37.5MG~A~073449~001~AB~Sep 23, 1993~No~RX~WATSON LABORATORIES
INC
~WATSON LABS~50MG;75MG~A~071851~001~AB~Nov 30, 1988~No~RX~WATSON LABORATORIES IN
C
~WATSON LABS~50MG;75MG~A~071969~001~~Apr 17, 1988~No~DISCN~WATSON LABORATORIES I
NC
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE~TABLET;ORAL~TRIAVIL 2-10~NEW RIVER~10M
G;2MG~N~014715~004~~Approved Prior to Jan 1, 1982~No~DISCN~NEW RIVER PHARMACEUTI
CALS INC
CALS INC
CALS INC
CALS INC
CALS INC
TRIAZOLAM~TABLET;ORAL~TRIAZOLAM~MYLAN PHARMS INC~0.125MG~A~074031~001~AB~Mar 25,
TRIAZOLAM~TABLET;ORAL~TRIAZOLAM~MYLAN PHARMS INC~0.25MG~A~074031~002~AB~Mar 25,
TRIAZOLAM~TABLET;ORAL~TRIAZOLAM~ROXANE~0.125MG~A~074224~001~AB~Jun 1, 1994~No~RX
TRIAZOLAM~TABLET;ORAL~TRIAZOLAM~ROXANE~0.25MG~A~074224~002~AB~Jun 1, 1994~No~RX~
TRIAZOLAM~TABLET;ORAL~TRIAZOLAM~WATSON LABS~0.125MG~A~074445~001~~Oct 20, 1995~N
TRIAZOLAM~TABLET;ORAL~TRIAZOLAM~WATSON LABS~0.25MG~A~074445~002~~Oct 20, 1995~No
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL~TABLET;ORAL~TRIBE
NZOR~DAIICHI SANKYO~EQ 5MG BASE;12.5MG;20MG~N~200175~001~~Jul 23, 2010~No~RX~DAI
ICHI SANKYO INC
NZOR~DAIICHI SANKYO~EQ 5MG BASE;12.5MG;40MG~N~200175~002~~Jul 23, 2010~No~RX~DAI
ICHI SANKYO INC
NZOR~DAIICHI SANKYO~EQ 5MG BASE;25MG;40MG~N~200175~003~~Jul 23, 2010~No~RX~DAIIC
HI SANKYO INC
NZOR~DAIICHI SANKYO~EQ 10MG BASE;12.5MG;40MG~N~200175~004~~Jul 23, 2010~No~RX~DA
IICHI SANKYO INC
NZOR~DAIICHI SANKYO~EQ 10MG BASE;25MG;40MG~N~200175~005~~Jul 23, 2010~Yes~RX~DAI
ICHI SANKYO INC
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLOREX~LANNETT~4MG~A~083436~001~~Approved Pri
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLOREX~LANNETT~4MG~A~085630~001~~Approved Pri
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLORMAS~MAST MM~4MG~A~086259~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~MM MAST AND CO
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLORMETHIAZIDE~IMPAX LABS~4MG~A~083967~001~~A
pproved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES INC
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLORMETHIAZIDE~PAR PHARM~2MG~A~087007~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PAR PHARMACEUTICAL INC
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLORMETHIAZIDE~PAR PHARM~4MG~A~087005~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~PAR PHARMACEUTICAL INC
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLORMETHIAZIDE~SANDOZ~4MG~A~086171~001~~Appro
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLORMETHIAZIDE~TG UNITED LABS~4MG~A~085568~00
TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLORMETHIAZIDE~WATSON LABS~2MG~A~083847~001~~
RESERPINE; TRICHLORMETHIAZIDE~TABLET;ORAL~TRICHLORMETHIAZIDE W/ RESERPINE~WATSON
LABS~0.1MG;4MG~A~085248~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABO
RATORIES INC
TRICLOFOS SODIUM~TABLET;ORAL~TRICLOS~SANOFI AVENTIS US~750MG~N~016809~002~~Appro
FENOFIBRATE~TABLET;ORAL~TRICOR~ABBOTT~54MG~N~021203~001~~Sep 4, 2001~No~DISCN~AB
BOTT LABORATORIES
FENOFIBRATE~TABLET;ORAL~TRICOR~ABBOTT~160MG~N~021203~003~~Sep 4, 2001~No~DISCN~A
BBOTT LABORATORIES
FENOFIBRATE~TABLET;ORAL~TRICOR~ABBVIE~48MG~N~021656~001~AB~Nov 5, 2004~No~RX~ABB
VIE INC
FENOFIBRATE~TABLET;ORAL~TRICOR~ABBVIE~145MG~N~021656~002~AB~Nov 5, 2004~Yes~RX~A
BBVIE INC
TRIMETHADIONE~TABLET;ORAL~TRIDIONE~ABBVIE~150MG~N~005856~009~~Approved Prior to
Jan 1, 1982~Yes~RX~ABBVIE INC
TRIFLUOPERAZINE HYDROCHLORIDE~TABLET;ORAL~TRIFLUOPERAZINE HYDROCHLORIDE~DURAMED
PHARMS BARR~EQ 1MG BASE~A~088967~001~~Apr 23, 1985~No~DISCN~DURAMED PHARMACEUTIC
ALS INC SUB BARR LABORATORIES INC
PHARMS BARR~EQ 10MG BASE~A~088970~001~~Apr 23, 1985~No~DISCN~DURAMED PHARMACEUTI
CALS INC SUB BARR LABORATORIES INC
TRIFLUOPERAZINE HYDROCHLORIDE~TABLET;ORAL~TRIFLUOPERAZINE HYDROCHLORIDE~IVAX PHA

RMS~EQ 1MG BASE~A~087612~001~~Nov 19, 1982~No~DISCN~IVAX PHARMACEUTICALS INC
TRIFLUOPERAZINE HYDROCHLORIDE~TABLET;ORAL~TRIFLUOPERAZINE HYDROCHLORIDE~MYLAN~EQ
1MG BASE~A~040209~001~AB~Jul 7, 1997~No~RX~MYLAN PHARMACEUTICALS INC
10MG BASE~A~040209~004~AB~Jul 7, 1997~Yes~RX~MYLAN PHARMACEUTICALS INC
TRIFLUOPERAZINE HYDROCHLORIDE~TABLET;ORAL~TRIFLUOPERAZINE HYDROCHLORIDE~SANDOZ~E
Q 1MG BASE~A~040153~001~~Oct 25, 1996~No~DISCN~SANDOZ INC
Q 1MG BASE~A~085785~001~AB~Approved Prior to Jan 1, 1982~No~RX~SANDOZ INC
TRIFLUOPERAZINE HYDROCHLORIDE~TABLET;ORAL~TRIFLUOPERAZINE HYDROCHLORIDE~WATSON L
ABS~EQ 1MG BASE~A~085975~001~~Jun 23, 1988~No~DISCN~WATSON LABORATORIES INC
FENOFIBRATE~TABLET;ORAL~TRIGLIDE~SKYEPHARMA AG~50MG~N~021350~001~~May 7, 2005~No
~DISCN~SKYEPHARMA AG
FENOFIBRATE~TABLET;ORAL~TRIGLIDE~SKYEPHARMA AG~160MG~N~021350~002~BX~May 7, 2005
~Yes~RX~SKYEPHARMA AG
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~HIKMA PH
ARMS LLC~2MG~A~040337~002~~Feb 16, 2000~No~DISCN~HIKMA PHARMACEUTICALS LLC
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~HIKMA PH
ARMS LLC~5MG~A~040337~001~~Feb 16, 2000~No~DISCN~HIKMA PHARMACEUTICALS LLC
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~NATCO PH
ARMA LTD~2MG~A~091630~001~AA~Nov 17, 2010~No~RX~NATCO PHARMA LTD
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~NATCO PH
ARMA LTD~5MG~A~091630~002~AA~Nov 17, 2010~No~RX~NATCO PHARMA LTD
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~NYLOS~5M
G~A~085622~001~~Approved Prior to Jan 1, 1982~No~DISCN~NYLOS TRADING CO INC
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~VANGARD~
2MG~A~088035~001~~Jul 30, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDI
CAL CO
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~VINTAGE
PHARMS~2MG~A~040254~001~AA~Dec 24, 1998~No~RX~VINTAGE PHARMACEUTICALS INC
TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~VINTAGE
PHARMS~5MG~A~040254~002~AA~Dec 24, 1998~No~RX~VINTAGE PHARMACEUTICALS INC

TRIHEXYPHENIDYL HYDROCHLORIDE~TABLET;ORAL~TRIHEXYPHENIDYL HYDROCHLORIDE~WATSON L
ABS~2MG~A~040184~001~~Feb 6, 1998~No~DISCN~WATSON LABORATORIES INC
ABS~2MG~A~084363~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES
INC
ABS~2MG~A~085117~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES
INC
ABS~5MG~A~040184~002~~Feb 6, 1998~No~DISCN~WATSON LABORATORIES INC
ABS~5MG~A~084364~001~AA~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES
INC
ABS~5MG~A~085105~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES
INC
PERPHENAZINE~TABLET;ORAL~TRILAFON~SCHERING~2MG~N~010775~001~~Approved Prior to J
PERPHENAZINE~TABLET;ORAL~TRILAFON~SCHERING~16MG~N~010775~004~~Approved Prior to
OXCARBAZEPINE~TABLET;ORAL~TRILEPTAL~NOVARTIS~150MG~N~021014~001~AB~Jan 14, 2000~
Yes~RX~NOVARTIS PHARMACEUTICALS CORP
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~TRILITRON~
NEWTRON PHARMS~60MG;2.5MG~A~088515~001~~Jan 9, 1985~No~DISCN~NEWTRON PHARMACEUTI
CALS INC
TRIMETHOPRIM~TABLET;ORAL~TRIMETHOPRIM~MUTUAL PHARM~100MG~A~070494~001~~Jan 22, 1
TRIMETHOPRIM~TABLET;ORAL~TRIMETHOPRIM~MUTUAL PHARM~200MG~A~070495~001~~Sep 24, 1
TRIMETHOPRIM~TABLET;ORAL~TRIMETHOPRIM~NOVEL LABS INC~100MG~A~091437~001~AB~Jun 1
TRIMETHOPRIM~TABLET;ORAL~TRIMETHOPRIM~TEVA~100MG~N~018679~001~AB~Jul 30, 1982~Ye
TRIMETHOPRIM~TABLET;ORAL~TRIMETHOPRIM~TEVA~200MG~A~071259~001~~Jun 18, 1987~No~D
TRIMETHOPRIM~TABLET;ORAL~TRIMETHOPRIM~WATSON LABS~100MG~A~070049~001~AB~Jun 6, 1
TRIMETHOPRIM~TABLET;ORAL~TRIMPEX~ROCHE~100MG~N~017952~001~~Approved Prior to Jan
TRIMETHOPRIM~TABLET;ORAL~TRIMPEX 200~ROCHE~200MG~N~017952~002~~Nov 9, 1982~No~DI
SCN~HOFFMANN LA ROCHE INC
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~ANABOLIC~5
0MG~A~083037~001~~Approved Prior to Jan 1, 1982~No~DISCN~ANABOLIC INC
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~BARR~50MG~
A~080744~001~~Approved Prior to Jan 1, 1982~No~DISCN~BARR LABORATORIES INC
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~HEATHER~50
MG~A~083989~001~~Approved Prior to Jan 1, 1982~No~DISCN~HEATHER DRUG CO INC
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~IMPAX LABS
~50MG~A~080785~001~~Approved Prior to Jan 1, 1982~No~DISCN~IMPAX LABORATORIES IN
C
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~LANNETT~50
MG~A~083557~001~~Approved Prior to Jan 1, 1982~No~DISCN~LANNETT CO INC

TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~NYLOS~50MG
~A~085412~001~~Approved Prior to Jan 1, 1982~No~DISCN~NYLOS TRADING CO INC
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~PARKE DAVI
S~25MG~A~083625~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARN
ER LAMBERT CO
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~PARKE DAVI
S~50MG~A~083626~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAVIS DIV WARN
ER LAMBERT CO
TRIPELENNAMINE HYDROCHLORIDE~TABLET;ORAL~TRIPELENNAMINE HYDROCHLORIDE~WATSON LAB
INC
INC
INC
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~TRIPHED~TE
VA~60MG;2.5MG~A~088630~001~~May 17, 1984~No~DISCN~TEVA PHARMACEUTICALS USA INC
TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)~TABLET;ORAL~TRIP
LE SULFA~PUREPAC PHARM~167MG;167MG;167MG~A~080086~001~~Approved Prior to Jan 1,
LE SULFAS~LEDERLE~167MG;167MG;167MG~N~006920~002~~Approved Prior to Jan 1, 1982~
No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
LE SULFOID~PAL PAK~167MG;167MG;167MG~A~080094~001~~Approved Prior to Jan 1, 1982
~No~DISCN~PAL PAK INC
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~TRIPROLIDI
NE AND PSEUDOEPHEDRINE~WATSON LABS~60MG;2.5MG~A~088318~002~~Jan 13, 1984~No~DISC
NE AND PSEUDOEPHEDRINE~WEST WARD~60MG;2.5MG~A~088117~001~~Apr 19, 1983~No~DISCN~
WEST WARD PHARMACEUTICAL CORP
TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~TRIPROLIDINE HYDROCHLORIDE~VITARINE~2.5MG
~A~085610~001~~Approved Prior to Jan 1, 1982~No~DISCN~VITARINE PHARMACEUTICALS I
NC
TRIPROLIDINE HYDROCHLORIDE~TABLET;ORAL~TRIPROLIDINE HYDROCHLORIDE~WATSON LABS~2.
NE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~IVAX SUB TEVA PHARMS~60MG;2.5
MG~A~085273~001~~Dec 12, 1984~No~DISCN~IVAX PHARMACEUTICALS INC SUB TEVA PHARMAC
EUTICALS USA
NE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE~SUPERPHARM~60MG;2.5MG~A~08857
8~001~~Feb 21, 1985~No~DISCN~SUPERPHARM CORP
TRIOXSALEN~TABLET;ORAL~TRISORALEN~VALEANT PHARM INTL~5MG~N~012697~001~~Approved
RANITIDINE BISMUTH CITRATE~TABLET;ORAL~TRITEC~GLAXOSMITHKLINE~400MG~N~020559~001
~~Aug 8, 1996~No~DISCN~GLAXOSMITHKLINE
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE~TABLET;ORAL~TRIUMEQ~VIIV HLTHC
ARE~EQ 600MG BASE;EQ 50MG BASE;300MG~N~205551~001~~Aug 22, 2014~Yes~RX~VIIV HEAL
THCARE CO
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE~TABLET;ORAL~TRIZIVIR~VIIV HLTHCARE~EQ 3
00MG BASE;150MG;300MG~N~021205~001~AB~Nov 14, 2000~Yes~RX~VIIV HEALTHCARE CO
TROSPIUM CHLORIDE~TABLET;ORAL~TROSPIUM CHLORIDE~APOTEX~20MG~A~091513~001~AB~Dec
TROSPIUM CHLORIDE~TABLET;ORAL~TROSPIUM CHLORIDE~GLENMARK GENERICS~20MG~A~091575~
001~AB~Aug 13, 2010~No~RX~GLENMARK GENERICS LTD
TROSPIUM CHLORIDE~TABLET;ORAL~TROSPIUM CHLORIDE~PADDOCK LLC~20MG~A~091573~001~AB

~Nov 17, 2010~No~RX~PADDOCK LABORATORIES LLC
TROVAFLOXACIN MESYLATE~TABLET;ORAL~TROVAN~PFIZER~EQ 100MG BASE~N~020759~001~~Dec
18, 1997~No~DISCN~PFIZER CENTRAL RESEARCH
TROVAFLOXACIN MESYLATE~TABLET;ORAL~TROVAN~PFIZER~EQ 200MG BASE~N~020759~002~~Dec
18, 1997~No~DISCN~PFIZER CENTRAL RESEARCH
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE~TABLET;ORAL~TRUVADA~GILEAD~200MG;30
0MG~N~021752~001~~Aug 2, 2004~Yes~RX~GILEAD SCIENCES INC
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE~TABLET;ORAL~TUSSIGON~KING PHAR
MS~1.5MG;5MG~A~088508~001~AA~Jul 30, 1985~Yes~RX~KING PHARMACEUTICALS RESEARCH A
ND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC
AMLODIPINE BESYLATE; TELMISARTAN~TABLET;ORAL~TWYNSTA~BOEHRINGER INGELHEIM~EQ 5MG
BASE;40MG~N~022401~001~AB~Oct 16, 2009~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICA
LS INC
AMLODIPINE BESYLATE; TELMISARTAN~TABLET;ORAL~TWYNSTA~BOEHRINGER INGELHEIM~EQ 5MG
BASE;80MG~N~022401~003~AB~Oct 16, 2009~No~RX~BOEHRINGER INGELHEIM PHARMACEUTICA
LS INC
AMLODIPINE BESYLATE; TELMISARTAN~TABLET;ORAL~TWYNSTA~BOEHRINGER INGELHEIM~EQ 10M
G BASE;40MG~N~022401~002~AB~Oct 16, 2009~No~RX~BOEHRINGER INGELHEIM PHARMACEUTIC
ALS INC
AMLODIPINE BESYLATE; TELMISARTAN~TABLET;ORAL~TWYNSTA~BOEHRINGER INGELHEIM~EQ 10M
G BASE;80MG~N~022401~004~AB~Oct 16, 2009~Yes~RX~BOEHRINGER INGELHEIM PHARMACEUTI
CALS INC
COBICISTAT~TABLET;ORAL~TYBOST~GILEAD SCIENCES INC~150MG~N~203094~001~~Sep 24, 20
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~TYCOLET~ORTHO MCNEIL PHARM~500
MG;5MG~A~089385~001~~Aug 27, 1986~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL INC
LAPATINIB DITOSYLATE~TABLET;ORAL~TYKERB~SMITHKLINE BEECHAM~EQ 250MG BASE~N~02205
9~001~~Mar 13, 2007~Yes~RX~SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~TYLENOL W/ CODEINE~ORTHO MCNEIL PHA
RM~325MG;7.5MG~A~085056~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL
PHARMACEUTICAL INC
RM~325MG;15MG~A~085056~002~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL
PHARMACEUTICAL INC
PHARMACEUTICAL INC
PHARMACEUTICAL INC
ACETAMINOPHEN; CODEINE PHOSPHATE~TABLET;ORAL~TYLENOL W/ CODEINE NO. 1~JANSSEN PH
ARMS~300MG;7.5MG~A~085055~001~~Approved Prior to Jan 1, 1982~No~DISCN~JANSSEN PH
ARMACEUTICALS INC
ARMS~300MG;15MG~A~085055~002~~Approved Prior to Jan 1, 1982~No~DISCN~JANSSEN PHA
RMACEUTICALS INC
ARMS~300MG;30MG~A~085055~003~AA~Approved Prior to Jan 1, 1982~Yes~RX~JANSSEN PHA
RMACEUTICALS INC
ARMS~300MG;60MG~A~085055~004~AA~Approved Prior to Jan 1, 1982~No~RX~JANSSEN PHAR
MACEUTICALS INC
TELBIVUDINE~TABLET;ORAL~TYZEKA~NOVARTIS~600MG~N~022011~001~~Oct 25, 2006~Yes~RX~
FEBUXOSTAT~TABLET;ORAL~ULORIC~TAKEDA PHARMS USA~40MG~N~021856~001~~Feb 13, 2009~
No~RX~TAKEDA PHARMACEUTICALS USA INC
FEBUXOSTAT~TABLET;ORAL~ULORIC~TAKEDA PHARMS USA~80MG~N~021856~002~~Feb 13, 2009~
Yes~RX~TAKEDA PHARMACEUTICALS USA INC
CEFADROXIL/CEFADROXIL HEMIHYDRATE~TABLET;ORAL~ULTRACEF~APOTHECON~EQ 1GM BASE~A~0
62390~001~~Jun 10, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB

CEFADROXIL/CEFADROXIL HEMIHYDRATE~TABLET;ORAL~ULTRACEF~BRISTOL~EQ 1GM BASE~A~062
408~001~~Aug 31, 1982~No~DISCN~BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE~TABLET;ORAL~ULTRACET~JANSSEN PHARMS~325MG;
37.5MG~N~021123~001~AB~Aug 15, 2001~Yes~RX~JANSSEN PHARMACEUTICALS INC
GRISEOFULVIN, ULTRAMICROCRYSTALLINE~TABLET;ORAL~ULTRAGRIS-165~PLIVA~165MG~A~0626
45~001~~Jun 30, 1992~No~DISCN~PLIVA INC
GRISEOFULVIN, ULTRAMICROCRYSTALLINE~TABLET;ORAL~ULTRAGRIS-330~PLIVA~330MG~A~0626
46~001~~Jun 30, 1992~No~DISCN~PLIVA INC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~ULTRAM~JANSSEN PHARMS~50MG~N~020281~002~AB~Ma
r 3, 1995~Yes~RX~JANSSEN PHARMACEUTICALS INC
TRAMADOL HYDROCHLORIDE~TABLET;ORAL~ULTRAM~JANSSEN PHARMS~100MG~N~020281~001~~Mar
3, 1995~No~DISCN~JANSSEN PHARMACEUTICALS INC
NAFCILLIN SODIUM~TABLET;ORAL~UNIPEN~WYETH AYERST~EQ 500MG BASE~N~050462~001~~App
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~UNIPRES~SO
LVAY~25MG;15MG;0.1MG~A~085893~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLVAY
PHARMACEUTICALS
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE~TABLET;ORAL~UNIPRES~SO
LVAY~25MG;15MG;0.1MG~A~086298~001~~Approved Prior to Jan 1, 1982~No~DISCN~SOLVAY
PHARMACEUTICALS
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~UNIRETIC~UCB INC~12.5MG
;7.5MG~N~020729~001~AB~Jun 27, 1997~No~RX~UCB INC
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~UNIRETIC~UCB INC~12.5MG
;15MG~N~020729~003~AB~Feb 14, 2002~No~RX~UCB INC
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~UNIRETIC~UCB INC~25MG;1
5MG~N~020729~002~AB~Jun 27, 1997~Yes~RX~UCB INC
DOXYLAMINE SUCCINATE~TABLET;ORAL~UNISOM~CHATTEM~25MG~N~018066~001~~Approved Prio
r to Jan 1, 1982~Yes~OTC~CHATTEM INC
CRYPTENAMINE TANNATES~TABLET;ORAL~UNITENSEN~MEDPOINTE PHARM HLC~260CSR UNIT~N~00
9217~001~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPO
INTE HEALTHCARE INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~UNITHROID~STEVENS J~0.025MG **See current Annua
l Edition, 1.8 Description of Special Situations, Levothyroxine Sodium~N~021210~
001~AB1,AB2,AB3~Aug 21, 2000~No~RX~JEROME STEVENS PHARMACEUTICALS INC
LEVOTHYROXINE SODIUM~TABLET;ORAL~UNITHROID~STEVENS J~0.05MG **See current Annual
012~AB1,AB2,AB3~Feb 8, 2008~No~RX~JEROME STEVENS PHARMACEUTICALS INC

1~AB1,AB2,AB3~Aug 21, 2000~Yes~RX~JEROME STEVENS PHARMACEUTICALS INC
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~UNIVASC~UCB INC~7.5MG~N~020312~001~AB~Apr 19
, 1995~No~RX~UCB INC
MOEXIPRIL HYDROCHLORIDE~TABLET;ORAL~UNIVASC~UCB INC~15MG~N~020312~002~AB~Apr 19,
1995~Yes~RX~UCB INC
BETHANECHOL CHLORIDE~TABLET;ORAL~URECHOLINE~ODYSSEY PHARMS~5MG~A~089095~001~AA~D
ec 19, 1985~Yes~RX~ODYSSEY PHARMACEUTICALS INC
BETHANECHOL CHLORIDE~TABLET;ORAL~URECHOLINE~ODYSSEY PHARMS~5MG~N~006536~003~~App
roved Prior to Jan 1, 1982~No~DISCN~ODYSSEY PHARMACEUTICALS INC
BETHANECHOL CHLORIDE~TABLET;ORAL~URECHOLINE~ODYSSEY PHARMS~10MG~A~088440~001~AA~
May 29, 1984~Yes~RX~ODYSSEY PHARMACEUTICALS INC
BETHANECHOL CHLORIDE~TABLET;ORAL~URECHOLINE~ODYSSEY PHARMS~10MG~N~006536~002~~Ap
proved Prior to Jan 1, 1982~No~DISCN~ODYSSEY PHARMACEUTICALS INC
May 29, 1984~Yes~RX~ODYSSEY PHARMACEUTICALS INC
Dec 19, 1985~Yes~RX~ODYSSEY PHARMACEUTICALS INC
BENZTHIAZIDE~TABLET;ORAL~URESE~PFIZER~25MG~N~012128~003~~Approved Prior to Jan 1
, 1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
METHENAMINE HIPPURATE~TABLET;ORAL~UREX~CNTY LINE PHARMS~1GM~N~016151~001~AB~Appr
oved Prior to Jan 1, 1982~No~RX~COUNTY LINE PHARMACEUTICALS LLC
FLAVOXATE HYDROCHLORIDE~TABLET;ORAL~URISPAS~ORTHO MCNEIL JANSSEN~100MG~N~016769~
001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL JANSSEN PHARMACEUTICALS
INC
SULFAMETHOXAZOLE~TABLET;ORAL~UROBAK~SHIONOGI~500MG~A~087307~001~~Approved Prior
to Jan 1, 1982~No~DISCN~SHIONOGI USA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~UROPLUS DS~SHIONOGI~800MG;160MG~A~071
816~001~~Sep 28, 1987~No~DISCN~SHIONOGI USA INC
SULFAMETHOXAZOLE; TRIMETHOPRIM~TABLET;ORAL~UROPLUS SS~SHIONOGI~400MG;80MG~A~0718
15~001~~Sep 28, 1987~No~DISCN~SHIONOGI USA INC
URSODIOL~TABLET;ORAL~URSO 250~FOREST LABS INC~250MG~N~020675~001~AB~Dec 10, 1997
~No~RX~FOREST LABORATORIES INC
URSODIOL~TABLET;ORAL~URSO FORTE~FOREST LABS INC~500MG~N~020675~002~AB~Jul 21, 20
URSODIOL~TABLET;ORAL~URSODIOL~GLENMARK GENERICS~250MG~A~090801~001~AB~Jul 12, 20
URSODIOL~TABLET;ORAL~URSODIOL~GLENMARK GENERICS~500MG~A~090801~002~AB~Jul 12, 20
URSODIOL~TABLET;ORAL~URSODIOL~IMPAX LABS INC~250MG~A~200826~001~AB~Dec 23, 2011~
No~RX~IMPAX LABORATORIES INC
URSODIOL~TABLET;ORAL~URSODIOL~IMPAX LABS INC~500MG~A~200826~002~AB~Dec 23, 2011~
No~RX~IMPAX LABORATORIES INC
URSODIOL~TABLET;ORAL~URSODIOL~PAR PHARM~250MG~A~202540~001~AB~Feb 14, 2013~No~RX
URSODIOL~TABLET;ORAL~URSODIOL~PAR PHARM~500MG~A~202540~002~AB~Feb 14, 2013~No~RX
URSODIOL~TABLET;ORAL~URSODIOL~TEVA PHARMS USA~250MG~A~079184~001~~May 13, 2009~N
URSODIOL~TABLET;ORAL~URSODIOL~TEVA PHARMS USA~500MG~A~079184~002~~May 13, 2009~N

PENICILLIN V POTASSIUM~TABLET;ORAL~UTICILLIN VK~PHARMACIA AND UPJOHN~EQ 250MG BA
SE~A~061651~001~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
PENICILLIN V POTASSIUM~TABLET;ORAL~UTICILLIN VK~PHARMACIA AND UPJOHN~EQ 500MG BA
SE~A~061651~002~~Approved Prior to Jan 1, 1982~No~DISCN~PHARMACIA AND UPJOHN CO
PENICILLIN V POTASSIUM~TABLET;ORAL~V-CILLIN K~LILLY~EQ 125MG BASE~A~060003~001~~
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~APOTEX INC~EQ
1GM BASE~A~090500~002~AB~Apr 4, 2014~No~RX~APOTEX INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~APOTEX INC~EQ
500MG BASE~A~090500~001~AB~Apr 4, 2014~No~RX~APOTEX INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~AUROBINDO PHAR
MA~EQ 1GM BASE~A~090682~002~AB~May 24, 2010~No~RX~AUROBINDO PHARMA LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~AUROBINDO PHAR
MA~EQ 500MG BASE~A~090682~001~AB~May 24, 2010~No~RX~AUROBINDO PHARMA LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~CIPLA LTD~EQ 1
GM BASE~A~077135~002~AB~May 24, 2010~No~RX~CIPLA LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~CIPLA LTD~EQ 5
00MG BASE~A~077135~001~AB~May 24, 2010~No~RX~CIPLA LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~DR REDDYS LABS
LTD~EQ 1GM BASE~A~079012~002~AB~May 24, 2010~No~RX~DR REDDYS LABORATORIES LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~DR REDDYS LABS
LTD~EQ 500MG BASE~A~079012~001~AB~May 24, 2010~No~RX~DR REDDYS LABORATORIES LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~JUBILANT GENER
ICS~EQ 1GM BASE~A~201506~002~AB~Apr 3, 2012~No~RX~JUBILANT GENERICS LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~JUBILANT GENER
ICS~EQ 500MG BASE~A~201506~001~AB~Apr 3, 2012~No~RX~JUBILANT GENERICS LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~MYLAN~EQ 1GM B
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~MYLAN~EQ 500MG
BASE~A~078070~001~AB~May 24, 2010~No~RX~MYLAN PHARMACEUTICALS INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~MYLAN PHARMS I
NC~EQ 1GM BASE~A~078518~002~AB~May 24, 2010~No~RX~MYLAN PHARMACEUTICALS INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~MYLAN PHARMS I
NC~EQ 500MG BASE~A~078518~001~AB~May 24, 2010~No~RX~MYLAN PHARMACEUTICALS INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~RANBAXY~EQ 1GM
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~RANBAXY~EQ 500
MG BASE~A~076588~001~AB~Jan 31, 2007~No~RX~RANBAXY LABORATORIES LTD
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~ROXANE~EQ 1GM
BASE~A~078656~002~AB~May 24, 2010~No~RX~ROXANE LABORATORIES INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~ROXANE~EQ 500M
G BASE~A~078656~001~AB~May 24, 2010~No~RX~ROXANE LABORATORIES INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~SANDOZ~EQ 1GM
BASE~A~077478~002~AB~May 24, 2010~No~RX~SANDOZ INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~SANDOZ~EQ 500M
G BASE~A~077478~001~AB~May 24, 2010~No~RX~SANDOZ INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~TEVA PHARMS~EQ
1GM BASE~A~077655~002~AB~May 24, 2010~No~RX~TEVA PHARMACEUTICALS USA
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~TEVA PHARMS~EQ
500MG BASE~A~077655~001~AB~May 24, 2010~No~RX~TEVA PHARMACEUTICALS USA
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~WATSON LABS IN
C~EQ 1GM BASE~A~090370~002~AB~Mar 16, 2011~No~RX~WATSON LABORATORIES INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~WATSON LABS IN
C~EQ 500MG BASE~A~090370~001~AB~Mar 16, 2011~No~RX~WATSON LABORATORIES INC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~WOCKHARDT~EQ 1
GM BASE~A~090216~002~AB~May 24, 2010~No~RX~WOCKHARDT LTD

VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALACYCLOVIR HYDROCHLORIDE~WOCKHARDT~EQ 5
00MG BASE~A~090216~001~AB~May 24, 2010~No~RX~WOCKHARDT LTD
VALGANCICLOVIR HYDROCHLORIDE~TABLET;ORAL~VALCYTE~HOFFMANN LA ROCHE~EQ 450MG BASE
~N~021304~001~AB~Mar 29, 2001~Yes~RX~HOFFMANN LA ROCHE INC
VALGANCICLOVIR HYDROCHLORIDE~TABLET;ORAL~VALGANCICLOVIR HYDROCHLORIDE~DR REDDYS
LABS LTD~EQ 450MG BASE~A~203511~001~AB~Nov 4, 2014~No~RX~DR REDDYS LABORATORIES
LTD
VALGANCICLOVIR HYDROCHLORIDE~TABLET;ORAL~VALGANCICLOVIR HYDROCHLORIDE~ENDO PHARM
S INC~EQ 450MG BASE~A~200790~001~AB~Nov 4, 2014~No~RX~ENDO PHARMACEUTICALS INC
DIAZEPAM~TABLET;ORAL~VALIUM~ROCHE~2MG~N~013263~002~AB~Approved Prior to Jan 1, 1
982~No~RX~HOFFMANN LA ROCHE INC
DIAZEPAM~TABLET;ORAL~VALIUM~ROCHE~5MG~N~013263~004~AB~Approved Prior to Jan 1, 1
DIAZEPAM~TABLET;ORAL~VALIUM~ROCHE~10MG~N~013263~006~AB~Approved Prior to Jan 1,
ANISOTROPINE METHYLBROMIDE~TABLET;ORAL~VALPIN 50~ENDO PHARMS~50MG~N~013428~001~~
Approved Prior to Jan 1, 1982~No~DISCN~ENDO PHARMACEUTICALS INC
VALSARTAN~TABLET;ORAL~VALSARTAN~ALEMBIC PHARMS LTD~40MG~A~091367~001~AB~Jan 5, 2
015~No~RX~ALEMBIC PHARMACEUTICALS LTD
VALSARTAN~TABLET;ORAL~VALSARTAN~ALEMBIC PHARMS LTD~80MG~A~091367~002~AB~Jan 5, 2
VALSARTAN~TABLET;ORAL~VALSARTAN~ALEMBIC PHARMS LTD~160MG~A~091367~003~AB~Jan 5,
VALSARTAN~TABLET;ORAL~VALSARTAN~ALEMBIC PHARMS LTD~320MG~A~091367~004~AB~Jan 5,
VALSARTAN~TABLET;ORAL~VALSARTAN~AUROBINDO PHARMA LTD~40MG~A~202223~001~AB~Jan 5,
VALSARTAN~TABLET;ORAL~VALSARTAN~AUROBINDO PHARMA LTD~80MG~A~202223~002~AB~Jan 5,
VALSARTAN~TABLET;ORAL~VALSARTAN~AUROBINDO PHARMA LTD~160MG~A~202223~003~AB~Jan 5
VALSARTAN~TABLET;ORAL~VALSARTAN~AUROBINDO PHARMA LTD~320MG~A~202223~004~AB~Jan 5
VALSARTAN~TABLET;ORAL~VALSARTAN~HETERO LABS LTD V~40MG~A~203311~001~AB~Jan 5, 20
VALSARTAN~TABLET;ORAL~VALSARTAN~IVAX PHARMS~40MG~A~077530~001~AB~Jan 5, 2015~No~
RX~IVAX PHARMACEUTICALS INC
VALSARTAN~TABLET;ORAL~VALSARTAN~IVAX PHARMS~80MG~A~077530~002~AB~Jan 5, 2015~No~
RX~IVAX PHARMACEUTICALS INC
VALSARTAN~TABLET;ORAL~VALSARTAN~IVAX PHARMS~160MG~A~077530~003~AB~Jan 5, 2015~No
~RX~IVAX PHARMACEUTICALS INC
VALSARTAN~TABLET;ORAL~VALSARTAN~IVAX PHARMS~320MG~A~077530~004~AB~Jan 5, 2015~No
~RX~IVAX PHARMACEUTICALS INC
VALSARTAN~TABLET;ORAL~VALSARTAN~JUBILANT GENERICS~40MG~A~203536~001~AB~Jan 5, 20
VALSARTAN~TABLET;ORAL~VALSARTAN~LUPIN LTD~40MG~A~201677~001~AB~Jan 5, 2015~No~RX
~LUPIN LTD
VALSARTAN~TABLET;ORAL~VALSARTAN~LUPIN LTD~80MG~A~201677~002~AB~Jan 5, 2015~No~RX

~LUPIN LTD
VALSARTAN~TABLET;ORAL~VALSARTAN~LUPIN LTD~160MG~A~201677~003~AB~Jan 5, 2015~No~R
X~LUPIN LTD
VALSARTAN~TABLET;ORAL~VALSARTAN~LUPIN LTD~320MG~A~201677~004~AB~Jan 5, 2015~No~R
X~LUPIN LTD
VALSARTAN~TABLET;ORAL~VALSARTAN~MYLAN LABS LTD~40MG~A~090866~001~AB~Jan 5, 2015~
VALSARTAN~TABLET;ORAL~VALSARTAN~MYLAN LABS LTD~80MG~A~090866~002~AB~Jan 5, 2015~
VALSARTAN~TABLET;ORAL~VALSARTAN~MYLAN LABS LTD~160MG~A~090866~003~AB~Jan 5, 2015
~No~RX~MYLAN LABORATORIES LTD
VALSARTAN~TABLET;ORAL~VALSARTAN~MYLAN LABS LTD~320MG~A~090866~004~AB~Jan 5, 2015
~No~RX~MYLAN LABORATORIES LTD
VALSARTAN~TABLET;ORAL~VALSARTAN~OHM LABS INC~40MG~A~077492~001~AB~Jun 26, 2014~N
o~RX~OHM LABORATORIES INC
VALSARTAN~TABLET;ORAL~VALSARTAN~OHM LABS INC~80MG~A~077492~002~AB~Jun 26, 2014~N
o~RX~OHM LABORATORIES INC
VALSARTAN~TABLET;ORAL~VALSARTAN~OHM LABS INC~160MG~A~077492~003~AB~Jun 26, 2014~
No~RX~OHM LABORATORIES INC
VALSARTAN~TABLET;ORAL~VALSARTAN~OHM LABS INC~320MG~A~077492~004~AB~Jun 26, 2014~
No~RX~OHM LABORATORIES INC
VALSARTAN~TABLET;ORAL~VALSARTAN~TORRENT PHARMS LTD~40MG~A~202728~001~AB~Jan 5, 2
VALSARTAN~TABLET;ORAL~VALSARTAN~TORRENT PHARMS LTD~80MG~A~202728~002~AB~Jan 5, 2
VALSARTAN~TABLET;ORAL~VALSARTAN~TORRENT PHARMS LTD~160MG~A~202728~003~AB~Jan 5,
VALSARTAN~TABLET;ORAL~VALSARTAN~TORRENT PHARMS LTD~320MG~A~202728~004~AB~Jan 5,
VALSARTAN~TABLET;ORAL~VALSARTAN~WATSON LABS INC~40MG~A~090642~001~AB~Jan 5, 2015
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~VALSARTAN AND HYDROCHLOROTHIAZIDE~ALE
MBIC LTD~12.5MG;80MG~A~201662~001~AB~Mar 21, 2013~No~RX~ALEMBIC LTD
MBIC LTD~25MG;160MG~A~201662~004~AB~Mar 21, 2013~No~RX~ALEMBIC LTD
MBIC LTD~25MG;320MG~A~201662~005~AB~Mar 21, 2013~No~RX~ALEMBIC LTD
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~VALSARTAN AND HYDROCHLOROTHIAZIDE~APO
TEX INC~12.5MG;80MG~A~203026~001~AB~Mar 21, 2013~No~RX~APOTEX INC
TEX INC~25MG;160MG~A~203026~004~AB~Mar 21, 2013~No~RX~APOTEX INC
TEX INC~25MG;320MG~A~203026~005~AB~Mar 21, 2013~No~RX~APOTEX INC
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~VALSARTAN AND HYDROCHLOROTHIAZIDE~AUR
OBINDO PHARMA LTD~12.5MG;80MG~A~202519~001~AB~Mar 21, 2013~No~RX~AUROBINDO PHARM
A LTD
OBINDO PHARMA LTD~12.5MG;160MG~A~202519~002~AB~Mar 21, 2013~No~RX~AUROBINDO PHAR
MA LTD
OBINDO PHARMA LTD~12.5MG;320MG~A~202519~003~AB~Mar 21, 2013~No~RX~AUROBINDO PHAR
MA LTD
OBINDO PHARMA LTD~25MG;160MG~A~202519~004~AB~Mar 21, 2013~No~RX~AUROBINDO PHARMA
LTD
OBINDO PHARMA LTD~25MG;320MG~A~202519~005~AB~Mar 21, 2013~No~RX~AUROBINDO PHARMA
LTD
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~VALSARTAN AND HYDROCHLOROTHIAZIDE~LUP
IN LTD~12.5MG;80MG~A~078946~003~AB~Mar 21, 2013~No~RX~LUPIN LTD
IN LTD~25MG;160MG~A~078946~005~AB~Mar 21, 2013~No~RX~LUPIN LTD
IN LTD~25MG;320MG~A~078946~002~AB~Mar 21, 2013~No~RX~LUPIN LTD
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~VALSARTAN AND HYDROCHLOROTHIAZIDE~MAC
LEODS PHARMS LTD~12.5MG;80MG~A~203145~001~AB~Apr 19, 2013~No~RX~MACLEODS PHARMAC
EUTICALS LTD
LEODS PHARMS LTD~12.5MG;160MG~A~203145~002~AB~Apr 19, 2013~No~RX~MACLEODS PHARMA
CEUTICALS LTD
LEODS PHARMS LTD~12.5MG;320MG~A~203145~003~AB~Apr 19, 2013~No~RX~MACLEODS PHARMA
CEUTICALS LTD
LEODS PHARMS LTD~25MG;160MG~A~203145~004~AB~Apr 19, 2013~No~RX~MACLEODS PHARMACE
UTICALS LTD
LEODS PHARMS LTD~25MG;320MG~A~203145~005~AB~Apr 19, 2013~No~RX~MACLEODS PHARMACE
UTICALS LTD
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~VALSARTAN AND HYDROCHLOROTHIAZIDE~MYL
AN PHARMS INC~12.5MG;80MG~A~078020~001~AB~Sep 21, 2012~No~RX~MYLAN PHARMACEUTICA
LS INC
AN PHARMS INC~12.5MG;160MG~A~078020~002~AB~Sep 21, 2012~No~RX~MYLAN PHARMACEUTIC
ALS INC
AN PHARMS INC~12.5MG;320MG~A~078020~004~AB~Sep 21, 2012~No~RX~MYLAN PHARMACEUTIC
ALS INC
AN PHARMS INC~25MG;160MG~A~078020~003~AB~Sep 21, 2012~No~RX~MYLAN PHARMACEUTICAL
S INC
AN PHARMS INC~25MG;320MG~A~078020~005~AB~Sep 21, 2012~No~RX~MYLAN PHARMACEUTICAL
S INC
HYDROCHLOROTHIAZIDE; VALSARTAN~TABLET;ORAL~VALSARTAN AND HYDROCHLOROTHIAZIDE~WAT
SON LABS INC~12.5MG;80MG~A~091519~001~AB~Mar 21, 2013~No~RX~WATSON LABORATORIES
INC
INC

INC
SON LABS INC~25MG;160MG~A~091519~004~AB~Mar 21, 2013~No~RX~WATSON LABORATORIES I
NC
SON LABS INC~25MG;320MG~A~091519~005~AB~Mar 21, 2013~No~RX~WATSON LABORATORIES I
NC
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALTREX~GLAXOSMITHKLINE~EQ 1GM BASE~N~020
487~002~AB~Jun 23, 1995~Yes~RX~GLAXOSMITHKLINE
VALACYCLOVIR HYDROCHLORIDE~TABLET;ORAL~VALTREX~GLAXOSMITHKLINE~EQ 500MG BASE~N~0
20487~001~AB~Jun 23, 1995~No~RX~GLAXOSMITHKLINE
ALISKIREN HEMIFUMARATE; VALSARTAN~TABLET;ORAL~VALTURNA~NOVARTIS~EQ 150MG BASE;16
0MG~N~022217~001~~Sep 16, 2009~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
ALISKIREN HEMIFUMARATE; VALSARTAN~TABLET;ORAL~VALTURNA~NOVARTIS~EQ 300MG BASE;32
0MG~N~022217~002~~Sep 16, 2009~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
CEFPODOXIME PROXETIL~TABLET;ORAL~VANTIN~PHARMACIA AND UPJOHN~EQ 100MG BASE~N~050
CEFPODOXIME PROXETIL~TABLET;ORAL~VANTIN~PHARMACIA AND UPJOHN~EQ 200MG BASE~N~050
VARDENAFIL HYDROCHLORIDE~TABLET;ORAL~VARDENAFIL HYDROCHLORIDE~TEVA PHARMS~2.5MG~
A~091347~001~AB~May 3, 2012~No~RX~TEVA PHARMACEUTICALS USA
VARDENAFIL HYDROCHLORIDE~TABLET;ORAL~VARDENAFIL HYDROCHLORIDE~TEVA PHARMS~5MG~A~
VARDENAFIL HYDROCHLORIDE~TABLET;ORAL~VARDENAFIL HYDROCHLORIDE~TEVA PHARMS~10MG~A
~091347~003~AB~May 3, 2012~No~RX~TEVA PHARMACEUTICALS USA
VARDENAFIL HYDROCHLORIDE~TABLET;ORAL~VARDENAFIL HYDROCHLORIDE~TEVA PHARMS~20MG~A
~091347~004~AB~May 3, 2012~No~RX~TEVA PHARMACEUTICALS USA
BEPRIDIL HYDROCHLORIDE~TABLET;ORAL~VASCOR~JOHNSON AND JOHNSON~200MG~N~019002~001
~~Dec 28, 1990~No~DISCN~JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPM
ENT LLC
ENT LLC
ENT LLC
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~VASERETIC~VALEANT INTL~5MG;12
.5MG~N~019221~003~AB~Jul 12, 1995~No~RX~VALEANT INTERNATIONAL BARBADOS SRL
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~VASERETIC~VALEANT INTL~10MG;2
5MG~N~019221~001~AB~Oct 31, 1986~Yes~RX~VALEANT INTERNATIONAL BARBADOS SRL
ENALAPRIL MALEATE~TABLET;ORAL~VASOTEC~VALEANT INTL~2.5MG~N~018998~005~AB~Jul 26,
ENALAPRIL MALEATE~TABLET;ORAL~VASOTEC~VALEANT INTL~5MG~N~018998~001~AB~Dec 24, 1
ENALAPRIL MALEATE~TABLET;ORAL~VASOTEC~VALEANT INTL~10MG~N~018998~002~AB~Dec 24,
ENALAPRIL MALEATE~TABLET;ORAL~VASOTEC~VALEANT INTL~20MG~N~018998~003~AB~Dec 24,
PENICILLIN V POTASSIUM~TABLET;ORAL~VEETIDS~APOTHECON~EQ 250MG BASE~A~061411~001~
~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
PENICILLIN V POTASSIUM~TABLET;ORAL~VEETIDS~APOTHECON~EQ 500MG BASE~A~061411~002~
~Approved Prior to Jan 1, 1982~No~DISCN~APOTHECON INC DIV BRISTOL MYERS SQUIBB
PENICILLIN V POTASSIUM~TABLET;ORAL~VEETIDS '250'~APOTHECON~EQ 250MG BASE~A~06116
CO
CO

CO
CO
CEPHRADINE~TABLET;ORAL~VELOSEF~BRISTOL MYERS SQUIBB~1GM~N~050530~001~~Approved P
rior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~ALEMBIC PHARMS L
TD~EQ 25MG BASE~A~078932~001~AB~Dec 14, 2010~No~RX~ALEMBIC PHARMACEUTICALS LTD
TD~EQ 37.5MG BASE~A~078932~002~AB~Dec 14, 2010~No~RX~ALEMBIC PHARMACEUTICALS LTD
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~AMNEAL PHARMS~EQ
25MG BASE~A~079098~001~AB~May 11, 2010~No~RX~AMNEAL PHARMACEUTICALS
37.5MG BASE~A~079098~002~AB~May 11, 2010~No~RX~AMNEAL PHARMACEUTICALS
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~AUROBINDO PHARMA
~EQ 37.5MG BASE~A~090555~002~AB~Apr 7, 2010~No~RX~AUROBINDO PHARMA LTD
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~DR REDDYS LABS L
TD~EQ 25MG BASE~A~078301~001~AB~Jun 13, 2008~No~RX~DR REDDYS LABORATORIES LTD
TD~EQ 37.5MG BASE~A~078301~002~AB~Jun 13, 2008~No~RX~DR REDDYS LABORATORIES LTD
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~HERITAGE PHARMS
INC~EQ 25MG BASE~A~078554~001~AB~Jan 9, 2009~No~RX~HERITAGE PHARMACEUTICALS INC
INC~EQ 37.5MG BASE~A~078554~002~AB~Jan 9, 2009~No~RX~HERITAGE PHARMACEUTICALS IN
C
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~MYLAN~EQ 25MG BA
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~MYLAN~EQ 37.5MG

BASE~A~077166~002~AB~Jun 13, 2008~No~RX~MYLAN PHARMACEUTICALS INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~MYLAN~EQ 100MG B
ASE~A~077166~005~AB~Jun 13, 2008~No~RX~MYLAN PHARMACEUTICALS INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~PLIVA HRVATSKA D
OO~EQ 25MG BASE~A~078517~001~~Jun 13, 2008~No~DISCN~PLIVA HRVATSKA DOO
OO~EQ 37.5MG BASE~A~078517~002~~Jun 13, 2008~No~DISCN~PLIVA HRVATSKA DOO
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~SANDOZ~EQ 25MG B
ASE~A~077515~001~~Jun 13, 2008~No~DISCN~SANDOZ INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~SANDOZ~EQ 37.5MG
BASE~A~077515~002~~Jun 13, 2008~No~DISCN~SANDOZ INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~SANDOZ~EQ 100MG
BASE~A~077515~005~~Jun 13, 2008~No~DISCN~SANDOZ INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~SUN PHARM INDS I
NC~EQ 25MG BASE~A~078627~001~AB~Jun 13, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIES
INC
NC~EQ 37.5MG BASE~A~078627~002~AB~Jun 13, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRI
ES INC
INC
INC
NC~EQ 100MG BASE~A~078627~005~AB~Jun 13, 2008~No~RX~SUN PHARMACEUTICAL INDUSTRIE
S INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~TEVA~EQ 25MG BAS
E~A~076690~001~AB~Aug 3, 2006~No~RX~TEVA PHARMACEUTICALS USA INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~TEVA~EQ 37.5MG B
ASE~A~076690~002~AB~Aug 3, 2006~No~RX~TEVA PHARMACEUTICALS USA INC
E~A~076690~003~AB~Aug 3, 2006~Yes~RX~TEVA PHARMACEUTICALS USA INC
E~A~076690~004~AB~Aug 3, 2006~No~RX~TEVA PHARMACEUTICALS USA INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~TEVA~EQ 100MG BA
SE~A~076690~005~AB~Aug 3, 2006~No~RX~TEVA PHARMACEUTICALS USA INC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~VINTAGE~EQ 25MG
BASE~A~090027~001~AB~Aug 4, 2010~No~RX~VINTAGE PHARMACEUTICALS LLC
VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~VINTAGE~EQ 37.5M
G BASE~A~090027~002~AB~Aug 4, 2010~No~RX~VINTAGE PHARMACEUTICALS LLC

VENLAFAXINE HYDROCHLORIDE~TABLET;ORAL~VENLAFAXINE HYDROCHLORIDE~ZYDUS PHARMS USA
~EQ 25MG BASE~A~077653~001~AB~Jun 13, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
~EQ 37.5MG BASE~A~077653~002~AB~Jun 13, 2008~No~RX~ZYDUS PHARMACEUTICALS USA INC
PROTOKYLOL HYDROCHLORIDE~TABLET;ORAL~VENTAIRE~SANOFI AVENTIS US~2MG~A~083459~001
ALBUTEROL SULFATE~TABLET;ORAL~VENTOLIN~GLAXOSMITHKLINE~EQ 2MG BASE~N~019112~001~
~Jul 10, 1986~No~DISCN~GLAXOSMITHKLINE
ALBUTEROL SULFATE~TABLET;ORAL~VENTOLIN~GLAXOSMITHKLINE~EQ 4MG BASE~N~019112~002~
~Jul 10, 1986~No~DISCN~GLAXOSMITHKLINE
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~ACTAVIS ELIZABETH~80
MG~A~071019~001~~Sep 24, 1986~No~DISCN~ACTAVIS ELIZABETH LLC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~ACTAVIS ELIZABETH~12
0MG~A~070468~001~~Sep 24, 1986~No~DISCN~ACTAVIS ELIZABETH LLC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~HERITAGE PHARMS INC~
80MG~A~071880~001~AB~Apr 5, 1988~No~RX~HERITAGE PHARMACEUTICALS INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~HERITAGE PHARMS INC~
120MG~A~071881~001~AB~Apr 5, 1988~No~RX~HERITAGE PHARMACEUTICALS INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~MUTUAL PHARM~80MG~A~
070482~001~~Sep 24, 1986~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~MUTUAL PHARM~80MG~A~
071489~002~~Jan 13, 1988~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~MUTUAL PHARM~120MG~A
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~MUTUAL PHARM~120MG~A
~071489~001~~Jan 13, 1988~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~MYLAN~80MG~A~071483~
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~MYLAN~120MG~A~071483
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~PLIVA~40MG~A~072751~
001~~Feb 23, 1996~No~DISCN~PLIVA INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~PLIVA~80MG~A~072124~
001~~Jan 26, 1989~No~DISCN~PLIVA INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~PLIVA~120MG~A~072125
~001~~Jan 26, 1989~No~DISCN~PLIVA INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~SANDOZ~40MG~A~073168
~001~~Jul 31, 1992~No~DISCN~SANDOZ INC
~001~~May 24, 1988~No~DISCN~SANDOZ INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~WARNER CHILCOTT~80MG
~A~070340~001~~Sep 24, 1986~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~WARNER CHILCOTT~120M
G~A~070341~001~~Sep 24, 1986~No~DISCN~WARNER CHILCOTT DIV WARNER LAMBERT CO
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~WATSON LABS~40MG~A~0
72923~001~~Jun 29, 1993~No~DISCN~WATSON LABORATORIES INC

70995~001~AB~Oct 1, 1986~No~RX~WATSON LABORATORIES INC
VERAPAMIL HYDROCHLORIDE~TABLET;ORAL~VERAPAMIL HYDROCHLORIDE~WATSON LABS~120MG~A~
070994~001~AB~Oct 1, 1986~No~RX~WATSON LABORATORIES INC
PIPOBROMAN~TABLET;ORAL~VERCYTE~ABBOTT~10MG~N~016245~001~~Approved Prior to Jan 1
PIPOBROMAN~TABLET;ORAL~VERCYTE~ABBOTT~25MG~N~016245~002~~Approved Prior to Jan 1
ALKAVERVIR~TABLET;ORAL~VERILOID~3M~2MG~N~007336~002~~Approved Prior to Jan 1, 19
ALKAVERVIR~TABLET;ORAL~VERILOID~3M~3MG~N~007336~003~~Approved Prior to Jan 1, 19
VERATRUM VIRIDE ROOT~TABLET;ORAL~VERTAVIS~MEDPOINTE PHARM HLC~130CSR UNIT~N~0056
91~002~~Approved Prior to Jan 1, 1982~No~DISCN~MEDPOINTE PHARMACEUTICALS MEDPOIN
TE HEALTHCARE INC
SOLIFENACIN SUCCINATE~TABLET;ORAL~VESICARE~ASTELLAS~5MG~N~021518~001~AB~Nov 19,
2004~No~RX~ASTELLAS PHARMA US INC
SOLIFENACIN SUCCINATE~TABLET;ORAL~VESICARE~ASTELLAS~10MG~N~021518~002~AB~Nov 19,
2004~Yes~RX~ASTELLAS PHARMA US INC
TRIFLUPROMAZINE HYDROCHLORIDE~TABLET;ORAL~VESPRIN~BRISTOL MYERS SQUIBB~10MG~N~01
VORICONAZOLE~TABLET;ORAL~VFEND~PF PRISM CV~50MG~N~021266~001~AB~May 24, 2002~No~
RX~PF PRISM CV
VORICONAZOLE~TABLET;ORAL~VFEND~PF PRISM CV~200MG~N~021266~002~AB~May 24, 2002~Ye
s~RX~PF PRISM CV
SILDENAFIL CITRATE~TABLET;ORAL~VIAGRA~PFIZER IRELAND~EQ 25MG BASE~N~020895~001~~
Mar 27, 1998~No~RX~PFIZER IRELAND PHARMACEUTICALS
SILDENAFIL CITRATE~TABLET;ORAL~VIAGRA~PFIZER IRELAND~EQ 50MG BASE~N~020895~002~~
Mar 27, 1998~No~RX~PFIZER IRELAND PHARMACEUTICALS
SILDENAFIL CITRATE~TABLET;ORAL~VIAGRA~PFIZER IRELAND~EQ 100MG BASE~N~020895~003~
~Mar 27, 1998~Yes~RX~PFIZER IRELAND PHARMACEUTICALS
DOXYCYCLINE HYCLATE~TABLET;ORAL~VIBRA-TABS~PFIZER~EQ 100MG BASE **Federal Regist
ficacy reasons**~N~050533~001~~Approved Prior to Jan 1, 1982~No~DISCN~PFIZER LAB
ORATORIES DIV PFIZER INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~VICODIN~ABBOTT~500MG;5MG~A~085
667~001~~Approved Prior to Jan 1, 1982~No~DISCN~ABBOTT LABORATORIES PHARMACEUTIC
AL PRODUCTS DIV
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~VICODIN~ABBVIE~500MG;5MG~A~088
058~001~~Jan 7, 1983~No~DISCN~ABBVIE INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~VICODIN ES~ABBVIE~750MG;7.5MG~
A~089736~001~~Dec 9, 1988~No~DISCN~ABBVIE INC
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~VICODIN HP~ABBVIE~660MG;10MG~A
~040117~001~~Sep 23, 1996~No~DISCN~ABBVIE INC
ASPIRIN; HYDROCODONE BITARTRATE~TABLET;ORAL~VICOPRIN~ABBOTT~500MG;5MG~A~086333~0
01~~Sep 14, 1983~No~DISCN~ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
HYDROCODONE BITARTRATE; IBUPROFEN~TABLET;ORAL~VICOPROFEN~ABBVIE~7.5MG;200MG~N~02
0716~001~AB~Sep 23, 1997~Yes~RX~ABBVIE INC

VILAZODONE HYDROCHLORIDE~TABLET;ORAL~VIIBRYD~FOREST LABS INC~10MG~N~022567~001~~
Jan 21, 2011~Yes~RX~FOREST LABORATORIES INC
Jan 21, 2011~No~RX~FOREST LABORATORIES INC
Jan 21, 2011~No~RX~FOREST LABORATORIES INC
LACOSAMIDE~TABLET;ORAL~VIMPAT~UCB INC~50MG~N~022253~001~~Oct 28, 2008~No~RX~UCB
INC
INC
INC
LACOSAMIDE~TABLET;ORAL~VIMPAT~UCB INC~200MG~N~022253~004~~Oct 28, 2008~Yes~RX~UC
B INC
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~TABLET;ORAL~VIOKACE~FOREST LABS INC~39,15
0USP UNITS;10,440USP UNITS;39,150USP UNITS~N~022542~001~~Mar 1, 2012~No~RX~FORES
T LABORATORIES INC
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~TABLET;ORAL~VIOKACE~FOREST LABS INC~78,30
0USP UNITS;20,880USP UNITS;78,300USP UNITS~N~022542~002~~Mar 1, 2012~Yes~RX~FORE
ST LABORATORIES INC
ROFECOXIB~TABLET;ORAL~VIOXX~MERCK~12.5MG~N~021042~001~~May 20, 1999~No~DISCN~MER
ROFECOXIB~TABLET;ORAL~VIOXX~MERCK~25MG~N~021042~002~~May 20, 1999~No~DISCN~MERCK
RESEARCH LABORATORIES DIV MERCK CO INC
ROFECOXIB~TABLET;ORAL~VIOXX~MERCK~50MG~N~021042~003~~Feb 25, 2000~No~DISCN~MERCK
NELFINAVIR MESYLATE~TABLET;ORAL~VIRACEPT~AGOURON~EQ 250MG BASE~N~020779~001~~Mar
14, 1997~Yes~RX~AGOURON PHARMACEUTICALS INC
NELFINAVIR MESYLATE~TABLET;ORAL~VIRACEPT~AGOURON~EQ 625MG BASE~N~021503~001~~Apr
30, 2003~Yes~RX~AGOURON PHARMACEUTICALS INC
NEVIRAPINE~TABLET;ORAL~VIRAMUNE~BOEHRINGER INGELHEIM~200MG~N~020636~001~AB~Jun 2
TENOFOVIR DISOPROXIL FUMARATE~TABLET;ORAL~VIREAD~GILEAD SCIENCES INC~150MG~N~021
356~002~~Jan 18, 2012~No~RX~GILEAD SCIENCES INC
356~001~~Oct 26, 2001~Yes~RX~GILEAD SCIENCES INC
SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE~TA
BLET;ORAL~VISICOL~SALIX PHARMS~0.398GM;1.102GM~N~021097~001~~Sep 21, 2000~No~DIS
CN~SALIX PHARMACEUTICALS INC
HYDROCHLOROTHIAZIDE; PINDOLOL~TABLET;ORAL~VISKAZIDE~NOVARTIS~25MG;5MG~N~018872~0
HYDROCHLOROTHIAZIDE; PINDOLOL~TABLET;ORAL~VISKAZIDE~NOVARTIS~25MG;10MG~N~018872~
PINDOLOL~TABLET;ORAL~VISKEN~NOVARTIS~5MG~N~018285~001~~Sep 3, 1982~No~DISCN~NOVA
RTIS PHARMACEUTICALS CORP
PINDOLOL~TABLET;ORAL~VISKEN~NOVARTIS~10MG~N~018285~002~~Sep 3, 1982~No~DISCN~NOV
ARTIS PHARMACEUTICALS CORP
ELVITEGRAVIR~TABLET;ORAL~VITEKTA~GILEAD SCIENCES INC~85MG~N~203093~001~~Sep 24,
2014~No~RX~GILEAD SCIENCES INC
ELVITEGRAVIR~TABLET;ORAL~VITEKTA~GILEAD SCIENCES INC~150MG~N~203093~002~~Sep 24,
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~VIVACTIL~ODYSSEY PHARMS~5MG~A~073644~001
~AB~Aug 24, 1995~No~RX~ODYSSEY PHARMACEUTICALS INC
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~VIVACTIL~ODYSSEY PHARMS~10MG~A~073645~00
1~AB~Aug 24, 1995~Yes~RX~ODYSSEY PHARMACEUTICALS INC
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~VIVACTIL~TEVA WOMENS~5MG~N~016012~001~~A

pproved Prior to Jan 1, 1982~No~DISCN~TEVA WOMENS HEALTH INC
PROTRIPTYLINE HYDROCHLORIDE~TABLET;ORAL~VIVACTIL~TEVA WOMENS~10MG~N~016012~002~~
Approved Prior to Jan 1, 1982~No~DISCN~TEVA WOMENS HEALTH INC
DIPHENIDOL HYDROCHLORIDE~TABLET;ORAL~VONTROL~GLAXOSMITHKLINE~EQ 25MG BASE~N~0160
VORICONAZOLE~TABLET;ORAL~VORICONAZOLE~MYLAN PHARMS INC~50MG~A~090547~001~AB~Apr
VORICONAZOLE~TABLET;ORAL~VORICONAZOLE~MYLAN PHARMS INC~200MG~A~090547~002~AB~Apr
VORICONAZOLE~TABLET;ORAL~VORICONAZOLE~SANDOZ INC~50MG~A~200265~001~AB~Dec 12, 20
11~No~RX~SANDOZ INC
VORICONAZOLE~TABLET;ORAL~VORICONAZOLE~SANDOZ INC~200MG~A~200265~002~AB~Dec 12, 2
VORICONAZOLE~TABLET;ORAL~VORICONAZOLE~TEVA PHARMS~50MG~A~091658~001~AB~Apr 6, 20
VORICONAZOLE~TABLET;ORAL~VORICONAZOLE~TEVA PHARMS~200MG~A~091658~002~AB~Apr 6, 2
PAZOPANIB HYDROCHLORIDE~TABLET;ORAL~VOTRIENT~GLAXOSMITHKLINE~EQ 200MG BASE~N~022
465~001~~Oct 19, 2009~Yes~RX~GLAXOSMITHKLINE
PAZOPANIB HYDROCHLORIDE~TABLET;ORAL~VOTRIENT~GLAXOSMITHKLINE~EQ 400MG BASE~N~022
465~002~~Oct 19, 2009~No~RX~GLAXOSMITHKLINE
EZETIMIBE; SIMVASTATIN~TABLET;ORAL~VYTORIN~MSD INTL~10MG;10MG~N~021687~001~~Jul
23, 2004~No~RX~MSD INTERNATIONAL GMBH
23, 2004~Yes~RX~MSD INTERNATIONAL GMBH
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~AMNEAL PHARMS~1MG~A~202202~001~AB~Ma
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~AMNEAL PHARMS~2.5MG~A~202202~003~AB~
Mar 4, 2013~No~RX~AMNEAL PHARMACEUTICALS
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~AMNEAL PHARMS~7.5MG~A~202202~008~AB~
Mar 4, 2013~No~RX~AMNEAL PHARMACEUTICALS
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~AMNEAL PHARMS~10MG~A~202202~009~AB~M
ar 4, 2013~No~RX~AMNEAL PHARMACEUTICALS
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~BARR~1MG~A~040145~001~AB~Mar 26, 199
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~BARR~2.5MG~A~040145~003~AB~Mar 26, 1
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~BARR~3MG~A~040145~008~AB~Nov 5, 1998
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~BARR~6MG~A~040145~009~AB~Nov 5, 1998

WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~BARR~7.5MG~A~040145~006~AB~Mar 26, 1
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~INVAGEN PHARMS~1MG~A~090935~001~AB~M
ay 25, 2011~No~RX~INVAGEN PHARMACEUTICALS INC
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~INVAGEN PHARMS~2.5MG~A~090935~003~AB
~May 25, 2011~No~RX~INVAGEN PHARMACEUTICALS INC
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~INVAGEN PHARMS~7.5MG~A~090935~008~AB
~May 25, 2011~No~RX~INVAGEN PHARMACEUTICALS INC
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~INVAGEN PHARMS~10MG~A~090935~009~AB~
May 25, 2011~No~RX~INVAGEN PHARMACEUTICALS INC
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~IPCA LABS LTD~1MG~A~200104~001~AB~Ju
n 27, 2013~No~RX~IPCA LABORATORIES LTD
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~IPCA LABS LTD~2.5MG~A~200104~003~AB~
Jun 27, 2013~No~RX~IPCA LABORATORIES LTD
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~IPCA LABS LTD~7.5MG~A~200104~008~AB~
Jun 27, 2013~No~RX~IPCA LABORATORIES LTD
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~IPCA LABS LTD~10MG~A~200104~009~AB~J
un 27, 2013~No~RX~IPCA LABORATORIES LTD
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~MYLAN~1MG~A~040415~001~AB~Sep 27, 20
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~MYLAN~2.5MG~A~040415~003~AB~Sep 29,
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~MYLAN~7.5MG~A~040415~008~AB~Sep 27,
WARFARIN SODIUM~TABLET;ORAL~WARFARIN
6~No~RX~PLIVA INC
6~No~RX~PLIVA INC
006~No~RX~PLIVA INC
6~No~RX~PLIVA INC
6~No~RX~PLIVA INC
6~No~RX~PLIVA INC
6~No~RX~PLIVA INC
006~No~RX~PLIVA INC
06~No~RX~PLIVA INC
9~No~RX~TARO PHARMACEUTICALS INC
SODIUM~PLIVA~1MG~A~040616~009~AB~Jul 5, 200
SODIUM~PLIVA~2.5MG~A~040616~002~AB~Jul 5, 2
SODIUM~PLIVA~7.5MG~A~040616~007~AB~Jul 5, 2
SODIUM~SANDOZ~1MG~A~040196~001~~Sep 30, 199
SODIUM~SANDOZ~2.5MG~A~040196~003~~Sep 30, 1
SODIUM~SANDOZ~3MG~A~040196~008~~Jul 26, 200
SODIUM~SANDOZ~6MG~A~040196~009~~Jul 26, 200
SODIUM~SANDOZ~7.5MG~A~040196~006~~Sep 30, 1
SODIUM~TARO~1MG~A~040301~002~AB~Jul 15, 199
SODIUM~TARO~2.5MG~A~040301~004~AB~Jul 15, 1
SODIUM~TARO~7.5MG~A~040301~009~AB~Jul 15, 1
SODIUM~USL PHARMA~2MG~A~088719~001~~Jun 27,
SODIUM~USL PHARMA~2.5MG~A~088720~001~~Aug 6
SODIUM~USL PHARMA~5MG~A~088721~001~~Jul 2,
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~WATSON LABS~2MG~A~086123~001~~Aug 17

WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~WATSON LABS~2.5MG~A~086120~001~~Aug
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~WATSON LABS~7.5MG~A~086118~001~~Aug
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~ZYDUS PHARMS USA~1MG~A~040663~001~AB
~May 30, 2006~No~RX~ZYDUS PHARMACEUTICALS USA INC
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~ZYDUS PHARMS USA~2.5MG~A~040663~003~
AB~May 30, 2006~No~RX~ZYDUS PHARMACEUTICALS USA INC
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~ZYDUS PHARMS USA~7.5MG~A~040663~008~
AB~May 30, 2006~No~RX~ZYDUS PHARMACEUTICALS USA INC
WARFARIN SODIUM~TABLET;ORAL~WARFARIN SODIUM~ZYDUS PHARMS USA~10MG~A~040663~009~A
B~May 30, 2006~No~RX~ZYDUS PHARMACEUTICALS USA INC
COLESEVELAM HYDROCHLORIDE~TABLET;ORAL~WELCHOL~DAIICHI SANKYO~625MG~N~021176~001~
~May 26, 2000~Yes~RX~DAIICHI SANKYO INC
BUPROPION HYDROCHLORIDE~TABLET;ORAL~WELLBUTRIN~GLAXOSMITHKLINE~50MG~N~018644~001
~~Dec 30, 1985~No~DISCN~GLAXOSMITHKLINE
~AB~Dec 30, 1985~No~RX~GLAXOSMITHKLINE
3~AB~Dec 30, 1985~Yes~RX~GLAXOSMITHKLINE
LEUCOVORIN CALCIUM~TABLET;ORAL~WELLCOVORIN~GLAXOSMITHKLINE~EQ 5MG BASE~N~018342~
LEUCOVORIN CALCIUM~TABLET;ORAL~WELLCOVORIN~GLAXOSMITHKLINE~EQ 25MG BASE~N~018342
~002~~Jul 8, 1983~No~DISCN~GLAXOSMITHKLINE
CAFFEINE; ERGOTAMINE TARTRATE~TABLET;ORAL~WIGRAINE~ORGANON USA INC~100MG;1MG~A~0
86562~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORGANON USA INC
PHENTERMINE HYDROCHLORIDE~TABLET;ORAL~WILPO~SANDOZ~8MG **Federal Register determ
asons**~N~012737~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ CONSUMER HEA
LTH CARE GROUP DIV SANDOZ PHARMACEUTICALS CORP
STANOZOLOL~TABLET;ORAL~WINSTROL~LUNDBECK INC~2MG~N~012885~001~~May 14, 1984~No~D
ISCN~LUNDBECK INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~WOLFINA~FOREST PHARMS~50MG~N~009255~008~~A
pproved Prior to Jan 1, 1982~No~DISCN~FOREST PHARMACEUTICALS INC
RAUWOLFIA SERPENTINA ROOT~TABLET;ORAL~WOLFINA~FOREST PHARMS~100MG~N~009255~006~~
Approved Prior to Jan 1, 1982~No~DISCN~FOREST PHARMACEUTICALS INC
ERYTHROMYCIN STEARATE~TABLET;ORAL~WYAMYCIN S~WYETH AYERST~EQ 250MG BASE~A~061675
ERYTHROMYCIN STEARATE~TABLET;ORAL~WYAMYCIN S~WYETH AYERST~EQ 500MG BASE~A~061675
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE~TABLET;ORAL~WYGESIC~CARACO~650MG;65MG~
A~084999~001~~Approved Prior to Jan 1, 1982~No~DISCN~CARACO PHARMACEUTICAL LABOR
ATORIES LTD
GUANABENZ ACETATE~TABLET;ORAL~WYTENSIN~WYETH AYERST~EQ 4MG BASE~N~018587~001~~Se
p 7, 1982~No~DISCN~WYETH AYERST LABORATORIES

GUANABENZ ACETATE~TABLET;ORAL~WYTENSIN~WYETH AYERST~EQ 8MG BASE~N~018587~002~~Se
p 7, 1982~No~DISCN~WYETH AYERST LABORATORIES
GUANABENZ ACETATE~TABLET;ORAL~WYTENSIN~WYETH AYERST~EQ 16MG BASE~N~018587~003~~S
ep 7, 1982~No~DISCN~WYETH AYERST LABORATORIES
PHENDIMETRAZINE TARTRATE~TABLET;ORAL~X-TROZINE~SHIRE RICHWOOD~35MG~A~086550~001~
~Approved Prior to Jan 1, 1982~No~DISCN~SHIRE RICHWOOD INC
ALPRAZOLAM~TABLET;ORAL~XANAX~PHARMACIA AND UPJOHN~0.25MG~N~018276~001~AB~Approve
d Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
ALPRAZOLAM~TABLET;ORAL~XANAX~PHARMACIA AND UPJOHN~0.5MG~N~018276~002~AB~Approved
Prior to Jan 1, 1982~No~RX~PHARMACIA AND UPJOHN CO
ALPRAZOLAM~TABLET;ORAL~XANAX~PHARMACIA AND UPJOHN~1MG~N~018276~003~AB~Approved P
rior to Jan 1, 1982~Yes~RX~PHARMACIA AND UPJOHN CO
ALPRAZOLAM~TABLET;ORAL~XANAX~PHARMACIA AND UPJOHN~2MG~N~018276~004~AB~Nov 27, 19
RIVAROXABAN~TABLET;ORAL~XARELTO~JANSSEN PHARMS~10MG~N~022406~001~~Jul 1, 2011~Ye
s~RX~JANSSEN PHARMACEUTICALS INC
RIVAROXABAN~TABLET;ORAL~XARELTO~JANSSEN PHARMS~15MG~N~022406~002~~Nov 4, 2011~No
~RX~JANSSEN PHARMACEUTICALS INC
RIVAROXABAN~TABLET;ORAL~XARELTO~JANSSEN PHARMS~20MG~N~022406~003~~Nov 4, 2011~Ye
s~RX~JANSSEN PHARMACEUTICALS INC
TOFACITINIB CITRATE~TABLET;ORAL~XELJANZ~PF PRISM CV~EQ 5MG BASE~N~203214~001~~No
v 6, 2012~Yes~RX~PF PRISM CV
CAPECITABINE~TABLET;ORAL~XELODA~HOFFMANN LA ROCHE~150MG~N~020896~001~AB~Apr 30,
CAPECITABINE~TABLET;ORAL~XELODA~HOFFMANN LA ROCHE~500MG~N~020896~002~AB~Apr 30,
TETRABENAZINE~TABLET;ORAL~XENAZINE~VALEANT PHARMS NORTH~12.5MG~N~021894~001~~Aug
15, 2008~No~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
TETRABENAZINE~TABLET;ORAL~XENAZINE~VALEANT PHARMS NORTH~25MG~N~021894~002~~Aug 1
5, 2008~Yes~RX~VALEANT PHARMACEUTICALS NORTH AMERICA LLC
RIFAXIMIN~TABLET;ORAL~XIFAXAN~SALIX PHARMS~200MG~N~021361~001~~May 25, 2004~Yes~
RIFAXIMIN~TABLET;ORAL~XIFAXAN~SALIX PHARMS~550MG~N~022554~001~~Mar 24, 2010~Yes~
LEVOCETIRIZINE DIHYDROCHLORIDE~TABLET;ORAL~XYZAL~UCB INC~5MG~N~022064~001~AB~May
25, 2007~Yes~RX~UCB INC
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL~YAZ~BAYER HLTHCARE~3MG;0.02MG~N~0216
76~001~AB~Mar 16, 2006~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
RITODRINE HYDROCHLORIDE~TABLET;ORAL~YUTOPAR~ASTRAZENECA~10MG~N~018555~001~~Appro
ZAFIRLUKAST~TABLET;ORAL~ZAFIRLUKAST~DR REDDYS LABS LTD~10MG~A~090372~001~AB~Nov
ZAFIRLUKAST~TABLET;ORAL~ZAFIRLUKAST~DR REDDYS LABS LTD~20MG~A~090372~002~AB~Nov
SPARFLOXACIN~TABLET;ORAL~ZAGAM~MYLAN~200MG~N~020677~001~~Dec 19, 1996~No~DISCN~M
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~ZANAFLEX~ACORDA~EQ 2MG BASE **Federal Regis
fficacy reasons**~N~020397~002~~Feb 4, 2000~No~DISCN~ACORDA THERAPEUTICS INC
TIZANIDINE HYDROCHLORIDE~TABLET;ORAL~ZANAFLEX~ACORDA~EQ 4MG BASE~N~020397~001~AB
~Nov 27, 1996~Yes~RX~ACORDA THERAPEUTICS INC
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~ZANTAC 150~BOEHRINGER INGELHEIM~EQ 150MG BA

SE~N~021698~001~~Aug 31, 2004~Yes~OTC~BOEHRINGER INGELHEIM
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~ZANTAC 150~BOEHRINGER INGELHEIM~EQ 150MG BA
SE~N~021698~002~~Mar 13, 2007~No~OTC~BOEHRINGER INGELHEIM
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~ZANTAC 150~GLAXO GRP LTD~EQ 150MG BASE~N~01
8703~001~AB~Jun 9, 1983~No~RX~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~ZANTAC 300~GLAXO GRP LTD~EQ 300MG BASE~N~01
8703~002~AB~Dec 9, 1985~Yes~RX~GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
RANITIDINE HYDROCHLORIDE~TABLET;ORAL~ZANTAC 75~BOEHRINGER INGELHEIM~EQ 75MG BASE
~N~020520~001~~Dec 19, 1995~No~OTC~BOEHRINGER INGELHEIM
METOLAZONE~TABLET;ORAL~ZAROXOLYN~UCB INC~2.5MG~N~017386~001~AB~Approved Prior to
Jan 1, 1982~No~RX~UCB INC
METOLAZONE~TABLET;ORAL~ZAROXOLYN~UCB INC~5MG~N~017386~002~AB~Approved Prior to J
an 1, 1982~Yes~RX~UCB INC
METOLAZONE~TABLET;ORAL~ZAROXOLYN~UCB INC~10MG~N~017386~003~AB~Approved Prior to
Jan 1, 1982~Yes~RX~UCB INC
BISOPROLOL FUMARATE~TABLET;ORAL~ZEBETA~TEVA WOMENS~5MG~N~019982~002~AB~Jul 31, 1
992~No~RX~TEVA WOMENS HEALTH INC
BISOPROLOL FUMARATE~TABLET;ORAL~ZEBETA~TEVA WOMENS~10MG~N~019982~001~AB~Jul 31,
1992~Yes~RX~TEVA WOMENS HEALTH INC
VEMURAFENIB~TABLET;ORAL~ZELBORAF~HOFFMANN LA ROCHE~240MG~N~202429~001~~Aug 17, 2
TEGASEROD MALEATE~TABLET;ORAL~ZELNORM~NOVARTIS~EQ 2MG BASE~N~021200~001~~Jul 24,
TEGASEROD MALEATE~TABLET;ORAL~ZELNORM~NOVARTIS~EQ 6MG BASE~N~021200~002~~Jul 24,
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~ZESTORETIC~ALVOGEN IPCO SARL~12.5MG;
10MG~N~019888~003~AB~Nov 18, 1993~No~RX~ALVOGEN IPCO SARL
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~ZESTORETIC~ALVOGEN IPCO SARL~12.5MG;
20MG~N~019888~001~AB~Sep 20, 1990~Yes~RX~ALVOGEN IPCO SARL
HYDROCHLOROTHIAZIDE; LISINOPRIL~TABLET;ORAL~ZESTORETIC~ALVOGEN IPCO SARL~25MG;20
MG~N~019888~002~AB~Jul 20, 1989~Yes~RX~ALVOGEN IPCO SARL
LISINOPRIL~TABLET;ORAL~ZESTRIL~ALVOGEN IPCO SARL~2.5MG~N~019777~005~AB~Apr 29, 1
993~No~RX~ALVOGEN IPCO SARL
LISINOPRIL~TABLET;ORAL~ZESTRIL~ALVOGEN IPCO SARL~5MG~N~019777~001~AB~May 19, 198
LISINOPRIL~TABLET;ORAL~ZESTRIL~ALVOGEN IPCO SARL~30MG~N~019777~006~AB~Jan 20, 19
88~Yes~RX~ALVOGEN IPCO SARL
EZETIMIBE~TABLET;ORAL~ZETIA~MSD INTL GMBH~10MG~N~021445~001~~Oct 25, 2002~Yes~RX
~MSD INTERNATIONAL GMBH
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ZIAC~TEVA WOMENS~2.5MG;6.25
MG~N~020186~003~AB~Mar 26, 1993~No~RX~TEVA WOMENS HEALTH INC
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ZIAC~TEVA WOMENS~5MG;6.25MG
~N~020186~001~AB~Mar 26, 1993~No~RX~TEVA WOMENS HEALTH INC
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE~TABLET;ORAL~ZIAC~TEVA WOMENS~10MG;6.25M
G~N~020186~002~AB~Mar 26, 1993~Yes~RX~TEVA WOMENS HEALTH INC
ABACAVIR SULFATE~TABLET;ORAL~ZIAGEN~VIIV HLTHCARE~EQ 300MG BASE~N~020977~001~AB~
Dec 17, 1998~Yes~RX~VIIV HEALTHCARE CO
HYDROCHLOROTHIAZIDE~TABLET;ORAL~ZIDE~SOLVAY~50MG~A~083925~001~~Approved Prior to
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~AUROBINDO~300MG~A~077267~001~AB~Sep 19, 2005~N
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~AUROBINDO PHARMA~60MG~N~022294~001~~Jul 23, 20
09~No~DISCN~AUROBINDO PHARMA LTD
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~CIPLA~300MG~A~090561~001~AB~Oct 27, 2010~No~RX

~CIPLA LTD
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~HETERO LABS LTD III~300MG~A~090092~001~AB~Apr
25, 2008~Yes~RX~HETERO LABS LTD UNIT III
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~MATRIX LABS LTD~100MG~N~200732~001~~Feb 23, 20
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~MYLAN PHARMS INC~300MG~A~078922~001~AB~Feb 14,
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~RANBAXY LABS LTD~300MG~A~077327~001~~Sep 19, 2
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~ROXANE~300MG~A~076844~001~AB~Sep 19, 2005~No~R
ZIDOVUDINE~TABLET;ORAL~ZIDOVUDINE~SUNSHINE LAKE~300MG~A~202058~001~AB~Oct 7, 201
1~No~RX~SUNSHINE LAKE PHARMA CO LTD
AZITHROMYCIN~TABLET;ORAL~ZITHROMAX~PFIZER~EQ 250MG BASE~N~050711~001~AB~Jul 18,
1996~No~RX~PFIZER INC
AZITHROMYCIN~TABLET;ORAL~ZITHROMAX~PFIZER~EQ 500MG BASE~N~050784~001~AB~May 24,
2002~No~RX~PFIZER INC
AZITHROMYCIN~TABLET;ORAL~ZITHROMAX~PFIZER~EQ 600MG BASE~N~050730~001~AB~Jun 12,
1996~Yes~RX~PFIZER CENTRAL RESEARCH
SIMVASTATIN~TABLET;ORAL~ZOCOR~MERCK~5MG~N~019766~001~AB~Dec 23, 1991~No~RX~MERCK
SIMVASTATIN~TABLET;ORAL~ZOCOR~MERCK~10MG~N~019766~002~AB~Dec 23, 1991~No~RX~MERC
K RESEARCH LABORATORIES DIV MERCK CO INC
SIMVASTATIN~TABLET;ORAL~ZOCOR~MERCK~80MG~N~019766~005~AB~Jul 10, 1998~Yes~RX~MER
ONDANSETRON HYDROCHLORIDE~TABLET;ORAL~ZOFRAN~GLAXOSMITHKLINE~EQ 4MG BASE~N~02010
3~001~AB~Dec 31, 1992~No~RX~GLAXOSMITHKLINE
3~002~AB~Dec 31, 1992~No~RX~GLAXOSMITHKLINE
03~003~AB~Aug 27, 1999~Yes~RX~GLAXOSMITHKLINE
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~APOTEX INC~2.5MG~A~202078~001~AB~May 14, 2
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~APOTEX INC~5MG~A~202078~002~AB~May 14, 201
3~No~RX~APOTEX INC
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~GLENMARK GENERICS~2.5MG~A~201779~001~AB~Ma
y 14, 2013~No~RX~GLENMARK GENERICS LTD
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~GLENMARK GENERICS~5MG~A~201779~002~AB~May
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~INVAGEN PHARMS~2.5MG~A~204284~001~AB~Apr 9
, 2014~No~RX~INVAGEN PHARMACEUTICALS INC
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~INVAGEN PHARMS~5MG~A~204284~002~AB~Apr 9,
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~JUBILANT GENERICS~2.5MG~A~202279~001~AB~No
v 20, 2014~No~RX~JUBILANT GENERICS LTD
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~JUBILANT GENERICS~5MG~A~202279~002~AB~Nov
20, 2014~No~RX~JUBILANT GENERICS LTD
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~MYLAN PHARMS INC~2.5MG~A~203186~001~AB~May
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~MYLAN PHARMS INC~5MG~A~203186~002~AB~May 1
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~SUN PHARMA GLOBAL~2.5MG~A~203476~001~AB~No
v 13, 2014~No~RX~SUN PHARMA GLOBAL FZE
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~SUN PHARMA GLOBAL~5MG~A~203476~002~AB~Nov
13, 2014~No~RX~SUN PHARMA GLOBAL FZE
ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~TEVA PHARMS USA~2.5MG~A~090861~001~AB~Mar

ZOLMITRIPTAN~TABLET;ORAL~ZOLMITRIPTAN~TEVA PHARMS USA~5MG~A~090861~002~AB~Mar 4,
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~ZOLOFT~PFIZER~EQ 25MG BASE~N~019839~005~AB~
Mar 6, 1996~No~RX~PFIZER PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~ZOLOFT~PFIZER~EQ 50MG BASE~N~019839~001~AB~
Dec 30, 1991~No~RX~PFIZER PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~ZOLOFT~PFIZER~EQ 100MG BASE~N~019839~002~AB
~Dec 30, 1991~Yes~RX~PFIZER PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~ZOLOFT~PFIZER~EQ 150MG BASE~N~019839~003~~D
ec 30, 1991~No~DISCN~PFIZER PHARMACEUTICALS INC
SERTRALINE HYDROCHLORIDE~TABLET;ORAL~ZOLOFT~PFIZER~EQ 200MG BASE~N~019839~004~~D
ec 30, 1991~No~DISCN~PFIZER PHARMACEUTICALS INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~APOTEX INC~5MG~A~077884~001~AB~A
pr 23, 2007~No~RX~APOTEX INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~APOTEX INC~10MG~A~077884~002~AB~
Apr 23, 2007~No~RX~APOTEX INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~AUROBINDO PHARMA~5MG~A~078413~00
1~AB~May 4, 2007~No~RX~AUROBINDO PHARMA LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~AUROBINDO PHARMA~10MG~A~078413~0
02~AB~May 4, 2007~No~RX~AUROBINDO PHARMA LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~CARLSBAD~5MG~A~077990~001~AB~Apr
23, 2007~No~RX~CARLSBAD TECHNOLOGY INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~CARLSBAD~10MG~A~077990~002~AB~Ap
r 23, 2007~No~RX~CARLSBAD TECHNOLOGY INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~CIPLA LTD~5MG~A~077388~001~AB~Ju
l 30, 2012~No~RX~CIPLA LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~CIPLA LTD~10MG~A~077388~002~AB~J
ul 30, 2012~No~RX~CIPLA LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~DR REDDYS LABS LTD~5MG~A~077985~
001~~Apr 23, 2007~No~DISCN~DR REDDYS LABORATORIES LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~DR REDDYS LABS LTD~10MG~A~077985
~002~~Apr 23, 2007~No~DISCN~DR REDDYS LABORATORIES LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~HIKMA~5MG~A~078129~001~AB~Apr 30
, 2008~No~RX~HIKMA PHARMACEUTICALS
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~HIKMA~10MG~A~078129~002~AB~Apr 3
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~INVAGEN PHARMS~5MG~A~078184~001~
AB~Sep 7, 2007~No~RX~INVAGEN PHARMACEUTICALS INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~INVAGEN PHARMS~10MG~A~078184~002
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~LEK PHARMS DD~5MG~A~077322~001~A
B~Apr 23, 2007~No~RX~LEK PHARMACEUTICALS DD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~LEK PHARMS DD~10MG~A~077322~002~
AB~Apr 23, 2007~No~RX~LEK PHARMACEUTICALS DD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~MUTUAL PHARMA~5MG~A~077288~001~~
Apr 23, 2007~No~DISCN~MUTUAL PHARMACAL CO
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~MUTUAL PHARMA~10MG~A~077288~002~
~Apr 23, 2007~No~DISCN~MUTUAL PHARMACAL CO
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~MYLAN~5MG~A~076578~001~AB~Apr 23
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~MYLAN~10MG~A~076578~002~AB~Apr 2
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~MYLAN PHARMS INC~5MG~A~078016~00
1~~Apr 23, 2007~No~DISCN~MYLAN PHARMACEUTICALS INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~MYLAN PHARMS INC~10MG~A~078016~0
02~~Apr 23, 2007~No~DISCN~MYLAN PHARMACEUTICALS INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~RANBAXY~5MG~A~078055~001~AB~Apr
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~RANBAXY~10MG~A~078055~002~AB~Apr

ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~ROXANE~5MG~A~077214~001~AB~Apr 2
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~ROXANE~10MG~A~077214~002~AB~Apr
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~SUN PHARM INDS INC~5MG~A~077359~
001~AB~Apr 23, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~SUN PHARM INDS INC~10MG~A~077359
~002~AB~Apr 23, 2007~No~RX~SUN PHARMACEUTICAL INDUSTRIES INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~SYNTHON PHARMS~5MG~A~077540~001~
~Apr 23, 2007~No~DISCN~SYNTHON PHARMACEUTICALS LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~SYNTHON PHARMS~10MG~A~077540~002
~~Apr 23, 2007~No~DISCN~SYNTHON PHARMACEUTICALS LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~TEVA~5MG~A~076410~001~AB~Apr 23,
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~TEVA~10MG~A~076410~002~AB~Apr 23
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~TORRENT PHARMS~5MG~A~077903~001~
AB~Aug 17, 2007~No~RX~TORRENT PHARMACEUTICALS LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~TORRENT PHARMS~10MG~A~077903~002
~AB~Aug 17, 2007~No~RX~TORRENT PHARMACEUTICALS LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~VINTAGE~5MG~A~078616~001~AB~Nov
21, 2008~No~RX~VINTAGE PHARMACEUTICALS LLC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~VINTAGE~10MG~A~078616~002~AB~Nov
21, 2008~No~RX~VINTAGE PHARMACEUTICALS LLC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~VIVIMED LABS~5MG~A~076062~001~~A
pr 23, 2007~No~DISCN~VIVIMED LABS ALATHUR PRIVATE LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~VIVIMED LABS~10MG~A~076062~002~~
Apr 23, 2007~No~DISCN~VIVIMED LABS ALATHUR PRIVATE LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~WATSON LABS~5MG~A~077773~001~~Ap
r 23, 2007~No~DISCN~WATSON LABORATORIES INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~WATSON LABS~10MG~A~077773~002~~A
pr 23, 2007~No~DISCN~WATSON LABORATORIES INC
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~WOCKHARDT~5MG~A~078426~001~AB~Ma
y 15, 2007~No~RX~WOCKHARDT LTD
ZOLPIDEM TARTRATE~TABLET;ORAL~ZOLPIDEM TARTRATE~WOCKHARDT~10MG~A~078426~002~AB~M
ay 15, 2007~No~RX~WOCKHARDT LTD
ZOLMITRIPTAN~TABLET;ORAL~ZOMIG~IPR~2.5MG~N~020768~001~AB~Nov 25, 1997~No~RX~IPR
PHARMACEUTICALS INC
ZOLMITRIPTAN~TABLET;ORAL~ZOMIG~IPR~5MG~N~020768~002~AB~Nov 25, 1997~Yes~RX~IPR P
HARMACEUTICALS INC
VORAPAXAR SULFATE~TABLET;ORAL~ZONTIVITY~MERCK SHARP DOHME~EQ 2.08MG BASE~N~20488
6~001~~May 8, 2014~Yes~RX~MERCK SHARP AND DOHME CORP
EVEROLIMUS~TABLET;ORAL~ZORTRESS~NOVARTIS~0.25MG~N~021560~001~~Apr 20, 2010~No~RX
EVEROLIMUS~TABLET;ORAL~ZORTRESS~NOVARTIS~0.5MG~N~021560~002~~Apr 20, 2010~No~RX~
EVEROLIMUS~TABLET;ORAL~ZORTRESS~NOVARTIS~0.75MG~N~021560~003~~Apr 20, 2010~Yes~R
ACYCLOVIR~TABLET;ORAL~ZOVIRAX~DELCOR ASSET~400MG~N~020089~001~AB~Apr 30, 1991~No
~RX~DELCOR ASSET CORP
ACYCLOVIR~TABLET;ORAL~ZOVIRAX~DELCOR ASSET~800MG~N~020089~002~AB~Apr 30, 1991~Ye
s~RX~DELCOR ASSET CORP
IDELALISIB~TABLET;ORAL~ZYDELIG~GILEAD SCIENCES INC~100MG~N~205858~001~~Jul 23, 2
014~No~RX~GILEAD SCIENCES INC
IDELALISIB~TABLET;ORAL~ZYDELIG~GILEAD SCIENCES INC~150MG~N~205858~002~~Jul 23, 2
ACETAMINOPHEN; HYDROCODONE BITARTRATE~TABLET;ORAL~ZYDONE~VINTAGE PHARMS LLC~400M
G;5MG~A~040288~001~~Nov 27, 1998~No~DISCN~VINTAGE PHARMACEUTICALS LLC

G;7.5MG~A~040288~002~~Nov 27, 1998~No~DISCN~VINTAGE PHARMACEUTICALS LLC
G;10MG~A~040288~003~~Nov 27, 1998~No~DISCN~VINTAGE PHARMACEUTICALS LLC
ZILEUTON~TABLET;ORAL~ZYFLO~CHIESI USA INC~300MG~N~020471~001~~Dec 9, 1996~No~DIS
CN~CHIESI USA INC
ZILEUTON~TABLET;ORAL~ZYFLO~CHIESI USA INC~600MG~N~020471~003~~Dec 9, 1996~Yes~RX
~CHIESI USA INC
ALLOPURINOL~TABLET;ORAL~ZYLOPRIM~PROMETHEUS LABS~100MG~N~016084~001~AB~Approved
Prior to Jan 1, 1982~No~RX~PROMETHEUS LABORATORIES INC
ALLOPURINOL~TABLET;ORAL~ZYLOPRIM~PROMETHEUS LABS~300MG~N~016084~002~AB~Approved
Prior to Jan 1, 1982~Yes~RX~PROMETHEUS LABORATORIES INC
OLANZAPINE~TABLET;ORAL~ZYPREXA~LILLY~2.5MG~N~020592~001~AB~Sep 30, 1996~No~RX~EL
I LILLY AND CO
OLANZAPINE~TABLET;ORAL~ZYPREXA~LILLY~5MG~N~020592~002~AB~Sep 30, 1996~Yes~RX~ELI
LILLY AND CO
OLANZAPINE~TABLET;ORAL~ZYPREXA~LILLY~7.5MG~N~020592~003~AB~Sep 30, 1996~No~RX~EL
I LILLY AND CO
OLANZAPINE~TABLET;ORAL~ZYPREXA~LILLY~10MG~N~020592~004~AB~Sep 30, 1996~No~RX~ELI
LILLY AND CO
LILLY AND CO
LILLY AND CO
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~ZYRTEC ALLERGY~MCNEIL CONSUMER~5MG~N~019835
~003~~Nov 16, 2007~No~OTC~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~ZYRTEC ALLERGY~MCNEIL CONSUMER~10MG~N~01983
5~004~~Nov 16, 2007~Yes~OTC~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~ZYRTEC HIVES RELIEF~MCNEIL CONSUMER~5MG~N~0
19835~005~~Nov 16, 2007~No~OTC~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
CETIRIZINE HYDROCHLORIDE~TABLET;ORAL~ZYRTEC HIVES RELIEF~MCNEIL CONSUMER~10MG~N~
019835~006~~Nov 16, 2007~Yes~OTC~MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
ABIRATERONE ACETATE~TABLET;ORAL~ZYTIGA~JANSSEN BIOTECH~250MG~N~202379~001~~Apr 2
8, 2011~Yes~RX~JANSSEN BIOTECH INC
LINEZOLID~TABLET;ORAL~ZYVOX~PHARMACIA AND UPJOHN~400MG **Federal Register determ
asons**~N~021130~001~~Apr 18, 2000~No~DISCN~PHARMACIA AND UPJOHN CO
LINEZOLID~TABLET;ORAL~ZYVOX~PHARMACIA AND UPJOHN~600MG~N~021130~002~~Apr 18, 200
MESTRANOL; NORETHYNODREL~TABLET;ORAL-20~ENOVID~GD SEARLE LLC~0.075MG;5MG~N~01097
6~004~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
MESTRANOL; NORETHYNODREL~TABLET;ORAL-20~ENOVID-E~GD SEARLE LLC~0.1MG;2.5MG~N~010
MESTRANOL; NORETHINDRONE~TABLET;ORAL-20~NORINYL~WATSON LABS~0.1MG;2MG~N~013625~0
ETHYNODIOL DIACETATE; MESTRANOL~TABLET;ORAL-20~OVULEN~GD SEARLE LLC~1MG;0.1MG~N~
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~ALESSE~WYETH PHARMS~0.02MG;0.1M
n for safety or efficacy reasons**~N~020683~001~~Mar 27, 1997~No~DISCN~WYETH PHA
RMACEUTICALS INC SUB PFIZER INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~AVIANE-21~DURAMED PHARMS BARR~0
.02MG;0.1MG~A~075796~002~~Apr 30, 2001~No~DISCN~DURAMED PHARMACEUTICALS INC SUB
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~BALZIVA-21~BARR~0.035MG;0.4MG~A~
076198~001~~Apr 22, 2004~No~DISCN~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~BREVICON 21-DAY~WATSON LABS~0.03
5MG;0.5MG~N~017566~001~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORI
ES INC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-21~CRYSELLE~DURAMED PHARMS BARR~0.03MG
;0.3MG~A~075840~001~AB~Nov 30, 2001~No~RX~DURAMED PHARMACEUTICALS INC SUB BARR L

ABORATORIES INC
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE~TABLET;ORAL-21~DEMULEN 1/35-21~GD SEARLE
LLC~0.035MG;1MG **Federal Register determination that product was not discontin
ued or withdrawn for safety or efficacy reasons**~N~018168~001~~Approved Prior t
o Jan 1, 1982~No~DISCN~GD SEARLE LLC
LLC~0.05MG;1MG~N~016927~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE L
LC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-21~DESOGEN~ORGANON USA INC~0.15MG;0.0
3MG~N~020071~001~~Dec 10, 1992~No~DISCN~ORGANON USA INC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-21~DESOGESTREL AND ETHINYL ESTRADIOL~
DURAMED PHARMS BARR~0.15MG;0.03MG~A~075256~001~~Aug 12, 1999~No~DISCN~DURAMED PH
ARMACEUTICALS INC SUB BARR LABORATORIES INC
MESTRANOL; NORETHYNODREL~TABLET;ORAL-21~ENOVID-E 21~GD SEARLE LLC~0.1MG;2.5MG~N~
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~ENPRESSE-21~DURAMED PHARMS BARR
~0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG~A~075809~001~~Jul 16, 2001~No~DISCN
~DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~ESTROSTEP 21~WARNER CHIL
COTT LLC~0.02MG,0.03MG,0.035MG;1MG,1MG,1MG~N~020130~001~~Oct 9, 1996~No~DISCN~WA
RNER CHILCOTT CO LLC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~GENCEPT 10/11-21~BARR~0.035MG,0.
035MG;0.5MG,1MG~A~072694~001~~Feb 28, 1992~No~DISCN~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~GILDESS 1.5/30~VINTAGE P
HARMS LLC~0.03MG;1.5MG~A~077075~002~AB~Jul 24, 2012~No~RX~VINTAGE PHARMACEUTICAL
S LLC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~GILDESS 1/20~VINTAGE PHA
RMS LLC~0.02MG;1MG~A~077077~002~AB~Jul 24, 2012~No~RX~VINTAGE PHARMACEUTICALS LL
C
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~JUNEL 1.5/30~BARR~0.03MG
;1.5MG~A~076381~001~AB~May 30, 2003~No~RX~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~JUNEL 1/20~BARR~0.02MG;1
MG~A~076380~001~AB~May 30, 2003~No~RX~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~LARIN 1.5/30~NOVAST LABS
LTD~0.03MG;1.5MG~A~202996~001~AB~Mar 20, 2014~No~RX~NOVAST LABORATORIES LTD
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~LARIN 1/20~NOVAST LABS L
TD~0.02MG;1MG~A~202995~001~AB~Dec 4, 2013~No~RX~NOVAST LABORATORIES LTD
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~LESSINA-21~BARR~0.02MG;0.1MG~A~
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~LEVLITE~BAYER HLTHCARE~0.02MG;0
.1MG~N~020860~001~~Jul 13, 1998~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~LEVONORGESTREL AND ETHINYL ESTR
ADIOL~BARR~0.02MG;0.1MG~A~075862~001~~Apr 29, 2003~No~DISCN~BARR LABORATORIES IN
C
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~LEVORA 0.15/30-21~WATSON LABS~0
.03MG;0.15MG~A~073592~001~~Dec 13, 1993~No~DISCN~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-21~LO/OVRAL~WYETH PHARMS INC~0.03MG;0.
3MG~N~017612~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICALS I
NC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~LOESTRIN 21 1.5/30~WARNE
R CHILCOTT LLC~0.03MG;1.5MG~N~017875~001~AB~Approved Prior to Jan 1, 1982~No~RX~
WARNER CHILCOTT CO LLC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~LOESTRIN 21 1/20~WARNER
CHILCOTT LLC~0.02MG;1MG~N~017876~001~AB~Approved Prior to Jan 1, 1982~No~RX~WARN
ER CHILCOTT CO LLC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-21~LOW-OGESTREL-21~WATSON LABS~0.03MG;
0.3MG~A~075288~001~~Jul 28, 1999~No~DISCN~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~MICROGESTIN 1.5/30~WATSO
N LABS~0.03MG;1.5MG~A~075548~002~AB~Jul 30, 2003~No~RX~WATSON LABORATORIES
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~MICROGESTIN 1/20~WATSON

LABS~0.02MG;1MG~A~075647~002~AB~Jul 30, 2003~No~RX~WATSON LABORATORIES
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~MODICON 21~ORTHO MCNEIL PHARM~0.
035MG;0.5MG~N~017488~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PH
ARMACEUTICAL INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~N.E.E. 1/35 21~LPI~0.035MG;1MG~A
~071541~001~~Dec 14, 1987~No~DISCN~LPI HOLDINGS INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~NORCEPT-E 1/35 21~ORTHO MCNEIL P
HARM~0.035MG;1MG~A~071545~001~~Feb 9, 1989~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL
INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~NORDETTE-21~TEVA BRANDED PHARM~
0.03MG;0.15MG~N~018668~001~~May 10, 1982~No~DISCN~TEVA BRANDED PHARMACEUTICAL PR
ODUCTS R AND D INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~NORETHIN 1/35E-21~WATSON LABS~0.
035MG;1MG~A~071480~001~~Apr 12, 1988~No~DISCN~WATSON LABORATORIES INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-21~NORETHIN 1/50M-21~WATSON LABS~0.05MG;1MG
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~NORETHINDRONE ACETATE AN
D ETHINYL ESTRADIOL~FAMY CARE LTD~0.02MG;1MG~A~202771~001~AB~Nov 6, 2013~No~RX~F
AMY CARE LTD
D ETHINYL ESTRADIOL~FAMY CARE LTD~0.03MG;1.5MG~A~202770~001~AB~Feb 19, 2015~No~R
X~FAMY CARE LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~NORETHINDRONE AND ETHINYL ESTRAD
IOL~WATSON LABS~0.035MG;0.4MG~A~078379~001~~Feb 23, 2010~No~DISCN~WATSON LABORAT
ORIES INC
IOL~WATSON LABS~0.035MG;0.5MG~A~070684~001~~Jan 29, 1987~No~DISCN~WATSON LABORAT
ORIES INC
IOL~WATSON LABS~0.035MG;1MG~A~070685~001~~Jan 29, 1987~No~DISCN~WATSON LABORATOR
IES INC
IOL (10/11)~WATSON LABS~0.035MG,0.035MG;0.5MG,1MG~A~071043~001~~Apr 1, 1988~No~D
IOL (7/14)~WATSON LABS~0.035MG,0.035MG;0.5MG,1MG~A~071041~001~~Sep 24, 1991~No~D
MESTRANOL; NORETHINDRONE~TABLET;ORAL-21~NORETHINDRONE AND MESTRANOL~WATSON LABS~
0.05MG;1MG~A~070758~001~~Jul 1, 1988~No~DISCN~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~NORINYL 1+35 21-DAY~ACTAVIS LABS
UT INC~0.035MG;1MG~N~017565~001~AB~Approved Prior to Jan 1, 1982~No~RX~ACTAVIS
LABORATORIES UT INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-21~NORINYL 1+50 21-DAY~WATSON LABS~0.05MG;1
MG~N~013625~002~~Approved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-21~NORINYL 1+80 21-DAY~GD SEARLE LLC~0.08MG
;1MG~N~016724~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~NORLESTRIN 21 1/50~PARKE
DAVIS~0.05MG;1MG~N~016749~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAV
IS LABORATORIES DIV WARNER LAMBERT CO
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~NORLESTRIN 21 2.5/50~PAR
KE DAVIS~0.05MG;2.5MG~N~016852~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE
DAVIS LABORATORIES DIV WARNER LAMBERT CO
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~NORTREL 0.5/35-21~BARR~0.035MG;0
.5MG~A~072692~001~~Feb 28, 1992~No~DISCN~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~NORTREL 1/35-21~BARR~0.035MG;1MG
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~NORTREL 7/7/7~BARR~0.035MG,0.035
MG,0.035MG;0.5MG,0.75MG,1MG~A~075478~001~~Aug 30, 2002~No~RX~BARR LABORATORIES I
NC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-21~OGESTREL 0.5/50-21~WATSON LABS~0.05

MG;0.5MG~A~075406~001~~Dec 15, 1999~No~DISCN~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-21~ORTHO CYCLEN-21~JANSSEN PHARMS~0.
035MG;0.25MG~N~019653~001~~Dec 29, 1989~No~DISCN~JANSSEN PHARMACEUTICALS INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-21~ORTHO TRI-CYCLEN~JANSSEN PHARMS~0
.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG~N~019697~002~~Jul 3, 1992~No~DISCN~
JANSSEN PHARMACEUTICALS INC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-21~ORTHO-CEPT~JANSSEN PHARMS~0.15MG;0
.03MG~N~020301~001~~Dec 14, 1992~No~DISCN~JANSSEN PHARMACEUTICALS INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~ORTHO-NOVUM 1/35-21~ORTHO MCNEIL
PHARM~0.035MG;1MG~N~017489~002~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MC
NEIL PHARMACEUTICAL INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-21~ORTHO-NOVUM 1/50 21~ORTHO MCNEIL PHARM~0
.05MG;1MG~N~012728~004~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHAR
MACEUTICAL INC
MACEUTICAL INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-21~ORTHO-NOVUM 10-21~ORTHO MCNEIL PHARM~0.0
6MG;10MG~N~012728~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARM
ACEUTICAL INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~ORTHO-NOVUM 10/11-21~ORTHO MCNEI
L JANSSEN~0.035MG,0.035MG;0.5MG,1MG~N~018354~001~~Jan 11, 1982~No~DISCN~ORTHO MC
NEIL JANSSEN PHARMACEUTICALS INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-21~ORTHO-NOVUM 2-21~ORTHO MCNEIL PHARM~0.1M
G;2MG~N~012728~005~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL PHARMACE
UTICAL INC
PHARM~0.035MG,0.035MG;0.5MG,1MG~N~019004~001~~Apr 4, 1984~No~DISCN~ORTHO MCNEIL
PHARMACEUTICAL INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~ORTHO-NOVUM 7/7/7-21~JANSSEN PHA
RMS~0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG~N~018985~001~~Apr 4, 1984~No~DISCN~
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~OVCON-35~WARNER CHILCOTT~0.035MG
;0.4MG~N~018127~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~OVCON-50~WARNER CHILCOTT~0.05MG;
1MG~N~018128~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT INC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-21~OVRAL~WYETH PHARMS~0.05MG;0.5MG~N~0
16672~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICALS INC SUB
PFIZER INC
ETHYNODIOL DIACETATE; MESTRANOL~TABLET;ORAL-21~OVULEN-21~GD SEARLE LLC~1MG;0.1MG
~N~016029~003~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~PORTIA-21~BARR~0.03MG;0.15MG~A~
075866~001~~May 23, 2002~No~DISCN~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-21~TRI-LEGEST 21~BARR~0.02M
G,0.03MG,0.035MG;1MG,1MG,1MG~A~076405~001~~Oct 26, 2007~No~RX~BARR LABORATORIES
INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-21~TRI-NORINYL 21-DAY~ACTAVIS LABS
UT INC~0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG~N~018977~001~~Apr 13, 1984~No~DIS
CN~ACTAVIS LABORATORIES UT INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~TRIPHASIL-21~WYETH PHARMS~0.03M
G,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that pro
duct was not discontinued or withdrawn for safety or efficacy reasons**~N~019192
~001~~Nov 1, 1984~No~DISCN~WYETH PHARMACEUTICALS INC SUB PFIZER INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-21~TRIVORA-21~WATSON LABS~0.03MG,0
.04MG,0.03MG;0.05MG,0.075MG,0.125MG~A~074538~001~~Dec 18, 1997~No~DISCN~WATSON L
ABORATORIES INC
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE~TABLET;ORAL-21~ZOVIA 1/35E-21~WATSON LAB
S~0.035MG;1MG~A~072720~001~~Dec 30, 1991~No~DISCN~WATSON LABORATORIES INC
S~0.05MG;1MG~A~072722~001~~Dec 30, 1991~No~DISCN~WATSON LABORATORIES INC

ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~ALESSE~WYETH PHARMS~0.02MG;0.1M
G~N~020683~002~~Mar 27, 1997~No~DISCN~WYETH PHARMACEUTICALS INC SUB PFIZER INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~ALTAVERA~SANDOZ~0.03MG;0.15MG~A
~079102~001~AB~Aug 3, 2010~No~RX~SANDOZ INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~ALYACEN 1/35~GLENMARK GENERICS~0
.035MG;1MG~A~091634~001~AB~Jan 19, 2012~No~RX~GLENMARK GENERICS LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~ALYACEN 7/7/7~GLENMARK GENERICS~
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG~A~091636~001~AB~Jan 19, 2012~No~RX~GLEN
MARK GENERICS LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~ARANELLE~BARR~0.035MG,0.035MG,0.
035MG;0.5MG,1MG,0.5MG~A~076783~001~AB~Sep 29, 2004~No~RX~BARR LABORATORIES INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~AVIANE-28~DURAMED PHARMS BARR~0
.02MG;0.1MG~A~075796~001~AB1~Apr 30, 2001~No~RX~DURAMED PHARMACEUTICALS INC SUB
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~BALZIVA-28~BARR~0.035MG;0.4MG~A~
076238~001~AB~Apr 22, 2004~No~RX~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~BREVICON 28-DAY~WATSON LABS~0.03
5MG;0.5MG~N~017743~001~AB~Approved Prior to Jan 1, 1982~No~RX~WATSON LABORATORIE
S INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~BRIELLYN~GLENMARK GENERICS~0.035
MG;0.4MG~A~090538~001~AB~Mar 22, 2011~No~RX~GLENMARK GENERICS LIMITED
NORETHINDRONE~TABLET;ORAL-28~CAMILA~BARR~0.35MG~A~076177~001~AB1~Oct 21, 2002~No
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-28~CRYSELLE~DURAMED PHARMS BARR~0.03MG
;0.3MG~A~075840~002~AB~Nov 30, 2001~No~RX~DURAMED PHARMACEUTICALS INC SUB BARR L
ABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~CYCLAFEM 1/35~VINTAGE PHARMS LLC
~0.035MG;1MG~A~076337~001~AB~Nov 12, 2010~No~RX~VINTAGE PHARMACEUTICALS LLC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~CYCLAFEM 7/7/7~VINTAGE PHARMS LL
C~0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG~A~076338~001~AB~Nov 16, 2010~No~RX~VI
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~CYCLESSA~ORGANON USA INC~0.1MG,0.1
25MG,0.15MG;0.025MG,0.025MG,0.025MG~N~021090~001~AB~Dec 20, 2000~Yes~RX~ORGANON
USA INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~DASETTA 1/35~NOVAST LABS LTD~0.0
35MG;1MG~A~090948~001~AB~Dec 22, 2011~No~RX~NOVAST LABORATORIES LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~DASETTA 7/7/7~NOVAST LABS LTD~0.
035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG~A~090946~001~AB~Dec 22, 2011~No~RX~NOVAST
LABORATORIES LTD
LLC~0.035MG;1MG~N~018160~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE
LLC
LLC~0.05MG;1MG~N~016936~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE L
LC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~DESOGEN~ORGANON USA INC~0.15MG;0.0
3MG~N~020071~002~AB~Dec 10, 1992~No~RX~ORGANON USA INC
DURAMED PHARMS BARR~0.15MG;0.03MG~A~075256~002~AB~Aug 12, 1999~No~RX~DURAMED PHA
RMACEUTICALS INC SUB BARR LABORATORIES INC
FAMY CARE LTD~0.15MG,N/A;0.02MG,0.01MG~A~202296~001~AB~Aug 30, 2013~No~RX~FAMY C
ARE LTD
NOVAST LABS LTD~0.15MG;0.03MG~A~091234~001~AB~Jul 12, 2013~No~RX~NOVAST LABORATO
RIES LTD
WATSON LABS~0.15MG,N/A;0.02MG,0.01MG~A~076916~001~AB~Dec 29, 2008~No~RX~WATSON L
ABORATORIES INC

WATSON LABS~0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG~A~077182~001~AB~Jan 24,
WATSON LABS~0.15MG;0.03MG~A~076915~001~AB~Jul 29, 2005~No~RX~WATSON LABORATORIES
INC
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL-28~DROSPIRENONE AND ETHINYL ESTRADIO
L~BARR~3MG;0.03MG~A~077527~001~AB~May 9, 2008~No~RX~BARR LABORATORIES INC
L~LUPIN LTD~3MG;0.03MG~A~201663~001~AB~Dec 18, 2012~No~RX~LUPIN LTD
L~WATSON LABS~3MG;0.03MG~A~090081~001~AB~Sep 7, 2010~No~RX~WATSON LABORATORIES I
NC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-28~ELINEST~NOVAST LABS LTD~0.03MG;0.3M
G~A~091105~001~AB~Mar 28, 2012~No~RX~NOVAST LABORATORIES LTD
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~EMOQUETTE~VINTAGE PHARMS LLC~0.15M
G;0.03MG~A~076675~001~AB~Feb 25, 2011~No~RX~VINTAGE PHARMACEUTICALS LLC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~ENPRESSE-28~DURAMED PHARMS BARR
~0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG~A~075809~002~AB~Jul 16, 2001~No~RX~
DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~ENSKYCE~LUPIN LTD~0.15MG;0.03MG~A~
NORETHINDRONE~TABLET;ORAL-28~ERRIN~BARR~0.35MG~A~076225~001~AB2~Oct 21, 2002~No~
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~ESTARYLLA~SANDOZ~0.035MG;0.25MG~A
~090794~001~AB~Jan 30, 2013~No~RX~SANDOZ INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~ESTROSTEP FE~WARNER CHIL
COTT LLC~0.02MG,0.03MG,0.035MG;1MG,1MG,1MG~N~020130~002~AB~Oct 9, 1996~Yes~RX~WA
RNER CHILCOTT CO LLC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~FALMINA~NOVAST LABS LTD~0.02MG;
0.1MG~A~090721~001~AB1~Mar 28, 2012~No~RX~NOVAST LABORATORIES LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~GENCEPT 10/11-28~BARR~0.035MG,0.
035MG;0.5MG,1MG~A~072697~001~~Feb 28, 1992~No~DISCN~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~GILDAGIA~VINTAGE PHARMS~0.035MG;
0.4MG~A~078376~001~AB~Nov 6, 2012~No~RX~VINTAGE PHARMACEUTICALS
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~GILDESS FE 1.5/30~VINTAG
E PHARMS LLC~0.03MG;1.5MG~A~077075~001~AB~Apr 28, 2005~No~RX~VINTAGE PHARMACEUTI
CALS LLC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~GILDESS FE 1/20~VINTAGE
PHARMS LLC~0.02MG;1MG~A~077077~001~AB~May 20, 2005~No~RX~VINTAGE PHARMACEUTICALS
LLC
NORETHINDRONE~TABLET;ORAL-28~HEATHER~GLENMARK GENERICS~0.35MG~A~090454~001~AB1~A
pr 23, 2010~No~RX~GLENMARK GENERICS LTD
NORETHINDRONE~TABLET;ORAL-28~JENCYCLA~LUPIN LTD~0.35MG~A~091323~001~AB2~Mar 28,
2013~No~RX~LUPIN LTD
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~JUNEL FE 1.5/30~BARR~0.0
3MG;1.5MG~A~076064~001~AB~Sep 18, 2003~No~RX~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~JUNEL FE 1/20~BARR~0.02M
G;1MG~A~076081~001~AB~Sep 18, 2003~No~RX~BARR LABORATORIES INC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~KARIVA~BARR~0.15MG,N/A;0.02MG,0.01
MG~A~075863~001~~Apr 5, 2002~Yes~RX~BARR LABORATORIES INC
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE~TABLET;ORAL-28~KELNOR~BARR~0.035MG;1MG~A
~076785~001~AB~May 23, 2005~No~RX~BARR LABORATORIES INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~KURVELO~LUPIN LTD~0.03MG;0.15MG
~A~091408~001~AB~Oct 17, 2012~No~RX~LUPIN LTD
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~LARIN FE 1.5/30~NOVAST L
ABS LTD~0.03MG;1.5MG~A~091453~001~AB~Aug 23, 2013~No~RX~NOVAST LABORATORIES LTD
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~LARIN FE 1/20~NOVAST LAB
S LTD~0.02MG;1MG~A~091454~001~AB~Aug 26, 2013~No~RX~NOVAST LABORATORIES LTD
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~LESSINA-28~BARR~0.02MG;0.1MG~A~
075803~002~AB2~Mar 20, 2002~No~RX~BARR LABORATORIES INC

ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~LEVLITE~BAYER HLTHCARE~0.02MG;0
.1MG~N~020860~002~~Jul 13, 1998~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~LEVONEST~NOVAST LABS LTD~0.03MG
,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG~A~090719~001~AB~Dec 29, 2010~No~RX~NOVAST
LABORATORIES LTD
ADIOL~BARR~0.02MG;0.1MG~A~075862~002~~Apr 29, 2003~No~DISCN~BARR LABORATORIES IN
C
ADIOL~FAMY CARE LTD~0.02MG;0.1MG~A~200245~001~AB1~Oct 9, 2013~No~RX~FAMY CARE LT
D
ADIOL~FAMY CARE LTD~0.02MG;0.1MG~A~202247~001~AB2~Dec 8, 2014~No~RX~FAMY CARE LT
D
ADIOL~FAMY CARE LTD~0.03MG;0.15MG~A~091663~001~AB~Dec 21, 2012~No~RX~FAMY CARE L
TD
ADIOL~HAUPT PHARMA~0.02MG;0.1MG~A~201108~001~AB1~Feb 5, 2014~No~RX~HAUPT PHARMA
INC
ADIOL~HAUPT PHARMA~0.03MG;0.15MG~A~201095~001~AB~Dec 8, 2014~No~RX~HAUPT PHARMA
INC
ADIOL~LUPIN LTD~0.02MG;0.1MG~A~091425~001~AB1~Jan 18, 2013~No~RX~LUPIN LTD
ADIOL~WATSON LABS~0.02MG;0.1MG~A~076625~001~AB1~Nov 18, 2004~Yes~RX~WATSON LABOR
ATORIES
ADIOL~WATSON LABS~0.02MG;0.1MG~A~077681~001~AB2~May 31, 2006~Yes~RX~WATSON LABOR
ATORIES INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~LEVORA 0.15/30-28~WATSON LABS~0
.03MG;0.15MG~A~073594~001~AB~Dec 13, 1993~No~RX~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-28~LO/OVRAL-28~WYETH PHARMS~0.03MG;0.3
MG~N~017802~001~AB~Approved Prior to Jan 1, 1982~No~RX~WYETH PHARMACEUTICALS INC
SUB PFIZER INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~LOESTRIN FE 1.5/30~WARNE
R CHILCOTT LLC~0.03MG;1.5MG~N~017355~001~AB~Approved Prior to Jan 1, 1982~Yes~RX
~WARNER CHILCOTT CO LLC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~LOESTRIN FE 1/20~WARNER
CHILCOTT~0.02MG;1MG~N~017354~001~AB~Approved Prior to Jan 1, 1982~No~RX~WARNER C
HILCOTT INC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-28~LOW-OGESTREL-28~WATSON LABS~0.03MG;
0.3MG~A~075288~002~AB~Jul 28, 1999~No~RX~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~MARLISSA~GLENMARK GENERICS~0.03
MG;0.15MG~A~091452~001~AB~Feb 29, 2012~No~RX~GLENMARK GENERICS LTD
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~MICROGESTIN FE 1.5/30~WA
TSON LABS~0.03MG;1.5MG~A~075548~001~AB~Feb 5, 2001~No~RX~WATSON LABORATORIES
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~MICROGESTIN FE 1/20~WATS
ON LABS~0.02MG;1MG~A~075647~001~AB~Feb 5, 2001~No~RX~WATSON LABORATORIES
NORETHINDRONE~TABLET;ORAL-28~MICRONOR~JANSSEN PHARMS~0.35MG~N~016954~001~AB2~App
roved Prior to Jan 1, 1982~Yes~RX~JANSSEN PHARMACEUTICALS INC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~MIRCETTE~TEVA BRANDED PHARM~0.15MG
,N/A;0.02MG,0.01MG **Federal Register determination that product was not discont
inued or withdrawn for safety or efficacy reasons**~N~020713~001~~Apr 22, 1998~N
o~DISCN~TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~MODICON 28~JANSSEN PHARMS~0.035M
G;0.5MG~N~017735~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~JANSSEN PHARMACEUTI
CALS INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~MONO-LINYAH~NOVAST LABS LTD~0.035

MG;0.25MG~A~090523~001~AB~May 23, 2012~No~RX~NOVAST LABORATORIES LTD
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~MYZILRA~VINTAGE PHARMS LLC~0.03
MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG~A~077502~001~AB~Nov 23, 2011~No~RX~VINTA
GE PHARMACEUTICALS LLC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~N.E.E. 1/35 28~LPI~0.035MG;1MG~A
~071542~001~~Dec 14, 1987~No~DISCN~LPI HOLDINGS INC
NORETHINDRONE~TABLET;ORAL-28~NOR-QD~WATSON LABS (UTAH)~0.35MG~N~017060~001~AB1~A
pproved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~NORCEPT-E 1/35 28~ORTHO MCNEIL P
HARM~0.035MG;1MG~A~071546~001~~Feb 9, 1989~No~DISCN~ORTHO MCNEIL PHARMACEUTICAL
INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~NORDETTE-28~TEVA BRANDED PHARM~
0.03MG;0.15MG~N~018782~001~AB~Jul 21, 1982~Yes~RX~TEVA BRANDED PHARMACEUTICAL PR
ODUCTS R AND D INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~NORETHIN 1/35E-28~WATSON LABS~0.
035MG;1MG~A~071481~001~~Apr 12, 1988~No~DISCN~WATSON LABORATORIES INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-28~NORETHIN 1/50M-28~WATSON LABS~0.05MG;1MG
NORETHINDRONE~TABLET;ORAL-28~NORETHINDRONE~FAMY CARE LTD~0.35MG~A~200980~001~AB2
~Jun 12, 2013~No~RX~FAMY CARE LTD
NORETHINDRONE~TABLET;ORAL-28~NORETHINDRONE~FAMY CARE LTD~0.35MG~A~201483~001~AB1
~Jun 24, 2013~No~RX~FAMY CARE LTD
NORETHINDRONE~TABLET;ORAL-28~NORETHINDRONE~GLENMARK GENERICS~0.35MG~A~091209~001
~AB2~Jul 21, 2010~No~RX~GLENMARK GENERICS LTD
NORETHINDRONE~TABLET;ORAL-28~NORETHINDRONE~HAUPT PHARMA~0.35MG~A~202260~001~AB1~
Aug 1, 2013~No~RX~HAUPT PHARMA INC
NORETHINDRONE~TABLET;ORAL-28~NORETHINDRONE~LUPIN LTD~0.35MG~A~091325~001~AB1~Sep
NORETHINDRONE~TABLET;ORAL-28~NORETHINDRONE~NOVAST LABS~0.35MG~A~200961~001~AB2~S
ep 13, 2013~No~RX~NOVAST LABORATORIES CHINA LTD
NORETHINDRONE~TABLET;ORAL-28~NORETHINDRONE~NOVAST LABS LTD~0.35MG~A~202014~001~A
B1~Sep 13, 2013~No~RX~NOVAST LABORATORIES LTD
D ETHINYL ESTRADIOL~FAMY CARE LTD~0.02MG;1MG~A~202772~001~AB~Nov 14, 2013~No~RX~
FAMY CARE LTD
D ETHINYL ESTRADIOL~FAMY CARE LTD~0.03MG;1.5MG~A~202741~001~AB~Feb 20, 2015~No~R
X~FAMY CARE LTD
D ETHINYL ESTRADIOL~WATSON LABS~0.02MG,0.03MG,0.035MG;1MG,1MG,1MG~A~076629~001~A
B~Mar 18, 2010~No~RX~WATSON LABORATORIES
IOL~FAMY CARE LTD~0.05MG;1MG~A~203006~001~AB~Aug 5, 2013~Yes~RX~FAMY CARE LTD
IOL~WATSON LABS~0.035MG;0.4MG~A~078323~001~AB~Feb 4, 2010~No~RX~WATSON LABORATOR
IES INC
IOL~WATSON LABS~0.035MG;0.5MG~A~070686~001~AB~Jan 29, 1987~No~RX~WATSON LABORATO
RIES INC
IOL~WATSON LABS~0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG~A~076393~001~~Feb 4, 20
IOL~WATSON LABS~0.035MG;1MG~A~070687~001~AB~Jan 29, 1987~No~RX~WATSON LABORATORI
ES INC
IOL (10/11)~WATSON LABS~0.035MG,0.035MG;0.5MG,1MG~A~071044~001~~Apr 1, 1988~No~R
IOL (7/14)~WATSON LABS~0.035MG,0.035MG;0.5MG,1MG~A~071042~001~~Sep 24, 1991~No~D

MESTRANOL; NORETHINDRONE~TABLET;ORAL-28~NORETHINDRONE AND MESTRANOL~WATSON LABS~
0.05MG;1MG~A~070759~001~~Jul 1, 1988~No~DISCN~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~NORGESTIMATE AND ETHINYL ESTRADIO
L~GLENMARK GENERICS~0.035MG;0.25MG~A~200538~001~AB~Apr 5, 2012~No~RX~GLENMARK GE
NERICS LTD
L~LUPIN PHARMS~0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG~A~200541~001~AB~Jun
25, 2012~No~RX~LUPIN PHARMACEUTICALS INC
L~WATSON LABS~0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG~A~090479~001~~Mar 9,
L~WATSON LABS~0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG~A~076626~001~~Aug 17
L~WATSON LABS~0.035MG;0.25MG~A~076627~001~~Aug 17, 2006~No~DISCN~WATSON LABORATO
RIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~NORINYL 1+35 28-DAY~ACTAVIS LABS
UT INC~0.035MG;1MG~N~017565~002~AB~Approved Prior to Jan 1, 1982~No~RX~ACTAVIS
LABORATORIES UT INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-28~NORINYL 1+50 28-DAY~WATSON LABS~0.05MG;1
MG~N~016659~001~~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-28~NORINYL 1+80 28-DAY~GD SEARLE LLC~0.08MG
;1MG~N~016725~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~NORLESTRIN 28 1/50~PARKE
DAVIS~0.05MG;1MG~N~016723~001~~Approved Prior to Jan 1, 1982~No~DISCN~PARKE DAV
IS LABORATORIES DIV WARNER LAMBERT CO
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE~TABLET;ORAL-28~NORLES
TRIN FE 1/50~PARKE DAVIS~0.05MG;75MG;1MG~N~016766~001~~Approved Prior to Jan 1,
1982~No~DISCN~PARKE DAVIS LABORATORIES DIV WARNER LAMBERT CO
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE~TABLET;ORAL-28~NORLES
TRIN FE 2.5/50~PARKE DAVIS~0.05MG;75MG;2.5MG~N~016854~001~~Approved Prior to Jan
1, 1982~No~DISCN~PARKE DAVIS LABORATORIES DIV WARNER LAMBERT CO
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE~TABLET;ORAL-28~NORQUEST FE~GD
SEARLE LLC~0.035MG;75MG;1MG~N~018926~001~~Jul 18, 1986~No~DISCN~GD SEARLE LLC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~NORTREL 0.5/35-28~BARR~0.035MG;0
.5MG~A~072695~001~AB~Feb 28, 1992~No~RX~BARR LABORATORIES INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~NORTREL 1/35-28~BARR~0.035MG;1MG
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~NORTREL 7/7/7~BARR~0.035MG,0.035
MG,0.035MG;0.5MG,0.75MG,1MG~A~075478~002~AB~Aug 30, 2002~No~RX~BARR LABORATORIES
INC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-28~OGESTREL 0.5/50-28~WATSON LABS~0.05
MG;0.5MG~A~075406~002~~Dec 15, 1999~Yes~RX~WATSON LABORATORIES INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~ORSYTHIA~VINTAGE PHARMS LLC~0.0
2MG;0.1MG~A~077099~001~AB1~May 11, 2011~No~RX~VINTAGE PHARMACEUTICALS LLC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~ORTHO CYCLEN-28~JANSSEN PHARMS~0.
035MG;0.25MG~N~019653~002~AB~Dec 29, 1989~Yes~RX~JANSSEN PHARMACEUTICALS INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~ORTHO TRI-CYCLEN~JANSSEN PHARMS~0
.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG~N~019697~001~AB~Jul 3, 1992~Yes~RX~
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~ORTHO TRI-CYCLEN LO~JANSSEN PHARM
S~0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG~N~021241~001~AB~Aug 22, 2002~Yes
~RX~JANSSEN PHARMACEUTICALS INC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~ORTHO-CEPT~JANSSEN PHARMS~0.15MG;0
.03MG~N~020301~002~AB~Dec 14, 1992~Yes~RX~JANSSEN PHARMACEUTICALS INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~ORTHO-NOVUM 1/35-28~JANSSEN PHAR
MS~0.035MG;1MG~N~017919~002~AB~Approved Prior to Jan 1, 1982~Yes~RX~JANSSEN PHAR
MACEUTICALS INC
MESTRANOL; NORETHINDRONE~TABLET;ORAL-28~ORTHO-NOVUM 1/50 28~ORTHO MCNEIL JANSSEN
~0.05MG;1MG~N~016709~001~~Approved Prior to Jan 1, 1982~No~DISCN~ORTHO MCNEIL JA
NSSEN PHARMACEUTICALS INC
MACEUTICAL INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~ORTHO-NOVUM 10/11-28~ORTHO MCNEI
L JANSSEN~0.035MG,0.035MG;0.5MG,1MG~N~018354~002~~Jan 11, 1982~No~DISCN~ORTHO MC
NEIL JANSSEN PHARMACEUTICALS INC
PHARM~0.035MG,0.035MG;0.5MG,1MG~N~019004~002~~Apr 4, 1984~No~DISCN~ORTHO MCNEIL
PHARMACEUTICAL INC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~ORTHO-NOVUM 7/7/7-28~JANSSEN PHA
RMS~0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG~N~018985~002~AB~Apr 4, 1984~Yes~RX~
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~OVCON-35~WARNER CHILCOTT LLC~0.0
35MG;0.4MG~N~017716~001~AB~Approved Prior to Jan 1, 1982~Yes~RX~WARNER CHILCOTT
CO LLC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~OVCON-50~WARNER CHILCOTT LLC~0.0
5MG;1MG~N~017576~001~~Approved Prior to Jan 1, 1982~No~DISCN~WARNER CHILCOTT CO
LLC
ETHINYL ESTRADIOL; NORGESTREL~TABLET;ORAL-28~OVRAL-28~WYETH PHARMS~0.05MG;0.5MG~
N~016806~001~~Approved Prior to Jan 1, 1982~No~DISCN~WYETH PHARMACEUTICALS INC S
UB PFIZER INC
ETHYNODIOL DIACETATE; MESTRANOL~TABLET;ORAL-28~OVULEN-28~GD SEARLE LLC~1MG;0.1MG
~N~016705~001~~Approved Prior to Jan 1, 1982~No~DISCN~GD SEARLE LLC
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~PHILITH~NOVAST LABS LTD~0.035MG;
0.4MG~A~090947~001~AB~Dec 22, 2011~No~RX~NOVAST LABORATORIES LTD
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~PIMTREA~NOVAST LABS LTD~0.15MG,N/A
;0.02MG,0.01MG~A~091247~001~AB~Aug 1, 2013~No~RX~NOVAST LABORATORIES LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~PIRMELLA 1/35~LUPIN LTD~0.035MG;
1MG~A~201512~001~AB~Apr 24, 2013~No~RX~LUPIN LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~PIRMELLA 7/7/7~LUPIN LTD~0.035MG
,0.035MG,0.035MG;0.5MG,0.75MG,1MG~A~201510~001~AB~Apr 24, 2013~No~RX~LUPIN LTD
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~PORTIA-28~BARR~0.03MG;0.15MG~A~
075866~002~AB~May 23, 2002~No~RX~BARR LABORATORIES INC
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE~TABLET;ORAL-28~PREMPHASE (PRE
MARIN;CYCRIN 14/14)~WYETH PHARMS INC~0.625MG,0.625MG;N/A,5MG~N~020303~002~~Dec 3
0, 1994~No~DISCN~WYETH PHARMACEUTICALS INC
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE~TABLET;ORAL-28~PREMPHASE 14/1
4~WYETH PHARMS INC~0.625MG,0.625MG;N/A,5MG~N~020527~002~~Nov 17, 1995~Yes~RX~WYE
TH PHARMACEUTICALS INC
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE~TABLET;ORAL-28~PREMPRO~WYETH
PHARMS INC~0.3MG;1.5MG~N~020527~005~~Jun 4, 2003~Yes~RX~WYETH PHARMACEUTICALS IN
C
PHARMS INC~0.45MG;1.5MG~N~020527~004~~Mar 12, 2003~Yes~RX~WYETH PHARMACEUTICALS
INC
PHARMS INC~0.625MG;2.5MG~N~020527~001~~Nov 17, 1995~Yes~RX~WYETH PHARMACEUTICALS
INC
PHARMS INC~0.625MG;5MG~N~020527~003~~Jan 9, 1998~Yes~RX~WYETH PHARMACEUTICALS IN
C
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE~TABLET;ORAL-28~PREMPRO (PREMA
RIN;CYCRIN)~WYETH PHARMS INC~0.625MG,0.625MG;2.5MG,2.5MG~N~020303~001~~Dec 30, 1
994~No~DISCN~WYETH PHARMACEUTICALS INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~PREVIFEM~VINTAGE PHARMS LLC~0.035
MG;0.25MG~A~076334~001~AB~Jan 9, 2004~No~RX~VINTAGE PHARMACEUTICALS LLC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~SPRINTEC~BARR~0.035MG;0.25MG~A~07

5804~001~AB~Sep 25, 2002~No~RX~BARR LABORATORIES INC
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL-28~SYEDA~SANDOZ~3MG;0.03MG~A~090114~
001~AB~Mar 28, 2011~No~RX~SANDOZ INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~TRI LO SPRINTEC~BARR LABS INC~0.0
25MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG~A~076784~001~~Jun 29, 2009~No~DISCN~B
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~TRI-ESTARYLLA~SANDOZ~0.035MG,0.03
5MG,0.035MG;0.18MG,0.215MG,0.25MG~A~090793~001~AB~Jan 30, 2013~No~RX~SANDOZ INC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE~TABLET;ORAL-28~TRI-LEGEST FE~BARR~0.02M
G,0.03MG,0.035MG;1MG,1MG,1MG~A~076105~001~AB~Oct 26, 2007~No~RX~BARR LABORATORIE
S INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~TRI-LINYAH~NOVAST LABS LTD~0.035M
G,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG~A~090524~001~AB~May 30, 2012~No~RX~NOVAS
T LABORATORIES LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~TRI-NORINYL 28-DAY~ACTAVIS LABS
UT INC~0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG~N~018977~002~AB~Apr 13, 1984~Yes~
RX~ACTAVIS LABORATORIES UT INC
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~TRI-PREVIFEM~VINTAGE PHARMS LLC~0
.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG~A~076335~001~AB~Mar 26, 2004~No~RX~
ETHINYL ESTRADIOL; NORGESTIMATE~TABLET;ORAL-28~TRI-SPRINTEC~BARR~0.035MG,0.035MG
,0.035MG;0.18MG,0.215MG,0.25MG~A~075808~001~AB~Dec 29, 2003~No~RX~BARR LABORATOR
IES INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~TRIPHASIL-28~WYETH PHARMS INC~0
.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG~N~019190~001~~Nov 1, 1984~No~DISCN~WY
ETH PHARMACEUTICALS INC
ETHINYL ESTRADIOL; LEVONORGESTREL~TABLET;ORAL-28~TRIVORA-28~WATSON LABS~0.03MG,0
.04MG,0.03MG;0.05MG,0.075MG,0.125MG~A~074538~002~AB~Dec 18, 1997~Yes~RX~WATSON L
ABORATORIES INC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~VELIVET~DURAMED PHARMS BARR~0.1MG,
0.125MG,0.15MG;0.025MG,0.025MG,0.025MG~A~076455~001~AB~Feb 24, 2004~No~RX~DURAME
D PHARMACEUTICALS INC SUB BARR LABORATORIES INC
DESOGESTREL; ETHINYL ESTRADIOL~TABLET;ORAL-28~VIORELE~GLENMARK GENERICS~0.15MG,N
/A;0.02MG,0.01MG~A~091346~001~AB~Apr 2, 2012~No~RX~GLENMARK GENERICS LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~VYFEMLA~LUPIN LTD~0.035MG;0.4MG~
A~201886~001~AB~Sep 26, 2013~No~RX~LUPIN LTD
ETHINYL ESTRADIOL; NORETHINDRONE~TABLET;ORAL-28~WERA~NOVAST LABS LTD~0.035MG;0.5
MG~A~091204~001~AB~Mar 27, 2012~No~RX~NOVAST LABORATORIES LTD
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL-28~YAELA~NOVAST LABS LTD~3MG;0.03MG~
A~202015~001~AB~Nov 19, 2014~No~RX~NOVAST LABORATORIES LTD
DROSPIRENONE; ETHINYL ESTRADIOL~TABLET;ORAL-28~YASMIN~BAYER HLTHCARE~3MG;0.03MG~
N~021098~001~AB~May 11, 2001~Yes~RX~BAYER HEALTHCARE PHARMACEUTICALS INC
S~0.035MG;1MG~A~072721~001~AB~Dec 30, 1991~No~RX~WATSON LABORATORIES INC
S~0.05MG;1MG~A~072723~001~~Dec 30, 1991~Yes~RX~WATSON LABORATORIES INC
ISOPROTERENOL HYDROCHLORIDE~TABLET;RECTAL, SUBLINGUAL~ISUPREL~SANOFI AVENTIS US~
ISOPROTERENOL HYDROCHLORIDE~TABLET;RECTAL, SUBLINGUAL~ISUPREL~SANOFI AVENTIS US~
FENTANYL CITRATE~TABLET;SUBLINGUAL~ABSTRAL~GALENA BIOPHARMA~EQ 0.1MG BASE~N~0225
10~001~~Jan 7, 2011~No~RX~GALENA BIOPHARMA
10~004~~Jan 7, 2011~Yes~RX~GALENA BIOPHARMA

ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ALKERGOT~SANDOZ~0.5MG~A~085153~001~~Approve
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ALKERGOT~SANDOZ~1MG~A~087417~001~~Approved
Prior to Jan 1, 1982~No~DISCN~SANDOZ INC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~ACTAVI
S ELIZABETH~EQ 2MG BASE~A~090819~001~AB~Feb 19, 2015~No~RX~ACTAVIS ELIZABETH LLC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~ACTAVI
S ELIZABETH~EQ 8MG BASE~A~090819~002~AB~Feb 19, 2015~No~RX~ACTAVIS ELIZABETH LLC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~BARR~E
Q 2MG BASE~A~090360~001~AB~May 7, 2010~No~RX~BARR LABORATORIES INC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~BARR~E
Q 8MG BASE~A~090360~002~AB~May 7, 2010~No~RX~BARR LABORATORIES INC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~ETHYPH
ARM~EQ 2MG BASE~A~090622~001~AB~Sep 24, 2010~No~RX~ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~ETHYPH
ARM~EQ 8MG BASE~A~090622~002~AB~Sep 24, 2010~No~RX~ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~MYLAN
PHARMS INC~EQ 2MG BASE~A~201066~001~AB~Mar 6, 2015~No~RX~MYLAN PHARMACEUTICALS I
NC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~MYLAN
PHARMS INC~EQ 8MG BASE~A~201066~002~AB~Mar 6, 2015~No~RX~MYLAN PHARMACEUTICALS I
NC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~ROXANE
~EQ 2MG BASE~A~078633~001~AB~Oct 8, 2009~No~RX~ROXANE LABORATORIES INC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPHINE HYDROCHLORIDE~ROXANE
~EQ 8MG BASE~A~078633~002~AB~Oct 8, 2009~Yes~RX~ROXANE LABORATORIES INC
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE~TABLET;SUBLINGUAL~BUPRENORPH
INE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE~ACTAVIS ELIZABETH~EQ 2MG BASE;EQ 0.
5MG BASE~A~091422~001~AB~Feb 22, 2013~No~RX~ACTAVIS ELIZABETH LLC
INE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE~ACTAVIS ELIZABETH~EQ 8MG BASE;EQ 2M
G BASE~A~091422~002~AB~Feb 22, 2013~Yes~RX~ACTAVIS ELIZABETH LLC
INE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE~AMNEAL PHARMS~EQ 8MG BASE;EQ 2MG BA
SE~A~203136~002~AB~Feb 22, 2013~No~RX~AMNEAL PHARMACEUTICALS
INE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE~ROXANE~EQ 2MG BASE;EQ 0.5MG BASE~A~
203326~001~AB~Jun 27, 2014~No~RX~ROXANE LABORATORIES INC
INE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE~ROXANE~EQ 8MG BASE;EQ 2MG BASE~A~20
3326~002~AB~Jun 27, 2014~No~RX~ROXANE LABORATORIES INC
INE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE~TEVA PHARMS USA~EQ 2MG BASE;EQ 0.5M
G BASE~A~091149~001~AB~Sep 8, 2014~No~RX~TEVA PHARMACEUTICALS USA
INE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE~TEVA PHARMS USA~EQ 8MG BASE;EQ 2MG
BASE~A~091149~002~AB~Sep 8, 2014~No~RX~TEVA PHARMACEUTICALS USA
INE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ~AMNEAL PHARMS~EQ 2MG BASE;EQ 0.5MG
BASE~A~203136~001~AB~Feb 22, 2013~No~RX~AMNEAL PHARMACEUTICALS
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~CIRCANOL~3M~0.5MG~A~084868~001~~Approved Pr
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~CIRCANOL~3M~1MG~A~085809~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~3M PHARMACEUTICALS INC
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~DEAPRIL-ST~BRISTOL MYERS SQUIBB~1MG~A~08502
0~002~~Approved Prior to Jan 1, 1982~No~DISCN~BRISTOL MYERS SQUIBB CO PHARMACEUT
ICAL RESEARCH INSTITUTE
ZOLPIDEM TARTRATE~TABLET;SUBLINGUAL~EDLUAR~MEDA PHARMS~5MG~N~021997~001~~Mar 13,

2009~No~RX~MEDA PHARMACEUTICALS
ZOLPIDEM TARTRATE~TABLET;SUBLINGUAL~EDLUAR~MEDA PHARMS~10MG~N~021997~002~~Mar 13
, 2009~Yes~RX~MEDA PHARMACEUTICALS
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~KV PHARM~0.5MG~A~085899~
001~~Approved Prior to Jan 1, 1982~No~DISCN~KV PHARMACEUTICAL CO
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~KV PHARM~0.5MG~A~086265~
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~KV PHARM~1MG~A~085900~00
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~KV PHARM~1MG~A~086264~00
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~LEDERLE~0.5MG~A~086984~0
01~~Approved Prior to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYA
NAMID CO
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~LEDERLE~1MG~A~086985~001
MID CO
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~MUTUAL PHARM~0.5MG~A~087
407~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~MUTUAL PHARM~1MG~A~08755
2~001~~Approved Prior to Jan 1, 1982~No~DISCN~MUTUAL PHARMACEUTICAL CO INC
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~SUPERPHARM~0.5MG~A~08923
3~001~~Sep 23, 1986~No~DISCN~SUPERPHARM CORP
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~SUPERPHARM~1MG~A~089234~
001~~Sep 23, 1986~No~DISCN~SUPERPHARM CORP
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~VANGARD~0.5MG~A~088013~0
01~~Sep 20, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~VANGARD~1MG~A~088014~001
~~Sep 20, 1982~No~DISCN~VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~WATSON LABS~0.5MG~A~0849
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~WATSON LABS~0.5MG~A~0872
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~WATSON LABS~1MG~A~085177
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~ERGOLOID MESYLATES~WATSON LABS~1MG~A~087183
ERGOTAMINE TARTRATE~TABLET;SUBLINGUAL~ERGOMAR~ROSEDALE THERAPEUTIC~2MG~A~087693~
001~~Feb 24, 1983~Yes~RX~ROSEDALE THERAPEUTICS
ERGOTAMINE TARTRATE~TABLET;SUBLINGUAL~ERGOSTAT~PARKE DAVIS~2MG~A~088337~001~~Jun
8, 1984~No~DISCN~PARKE DAVIS DIV WARNER LAMBERT CO
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~GERIMAL~WATSON LABS~0.5MG~A~086189~001~~App
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~GERIMAL~WATSON LABS~1MG~A~086188~001~~Appro
ved Prior to Jan 1, 1982~No~DISCN~WATSON LABORATORIES INC
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~HYDERGINE~NOVARTIS~0.5MG~N~009087~002~~Appr
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~HYDERGINE~NOVARTIS~1MG~N~009087~001~~Approv
ed Prior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~HYDROGENATED ERGOT ALKALOIDS~IVAX PHARMS~0.
5MG~A~087186~001~~Approved Prior to Jan 1, 1982~No~DISCN~IVAX PHARMACEUTICALS IN
C
ERGOLOID MESYLATES~TABLET;SUBLINGUAL~HYDROGENATED ERGOT ALKALOIDS~IVAX PHARMS~1M
ZOLPIDEM TARTRATE~TABLET;SUBLINGUAL~INTERMEZZO~PURDUE PHARMA~1.75MG~N~022328~001
~~Nov 23, 2011~No~RX~PURDUE PHARMA PRODUCTS LP
ZOLPIDEM TARTRATE~TABLET;SUBLINGUAL~INTERMEZZO~PURDUE PHARMA~3.5MG~N~022328~002~
~Nov 23, 2011~Yes~RX~PURDUE PHARMA PRODUCTS LP
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISORDIL~BIOVAIL~2.5MG~N~012940~004~~Jul 2
9, 1988~No~DISCN~BIOVAIL LABORATORIES INC

ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISORDIL~BIOVAIL~5MG~N~012940~003~~Jul 29,
1988~No~DISCN~BIOVAIL LABORATORIES INC
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISORDIL~BIOVAIL~10MG **Federal Register d
cy reasons**~N~012940~005~~Jul 29, 1988~No~DISCN~BIOVAIL LABORATORIES INC
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~HIKMA INTL PHARMS~2.
5MG~A~086054~001~~Oct 29, 1987~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~HIKMA INTL PHARMS~5M
G~A~086055~001~~Nov 2, 1987~No~DISCN~HIKMA INTERNATIONAL PHARMACEUTICALS LLC
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~MUTUAL PHARM~2.5MG~A
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~MUTUAL PHARM~5MG~A~0
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~MUTUAL PHARM~10MG~A~
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~SANDOZ~2.5MG~A~08622
5~001~~Feb 19, 1988~No~DISCN~SANDOZ INC
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~SANDOZ~5MG~A~086222~
001~~Feb 19, 1988~No~DISCN~SANDOZ INC
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~WATSON LABS~2.5MG **
r safety or efficacy reasons**~A~086033~001~~Feb 26, 1988~No~DISCN~WATSON LABORA
TORIES INC
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~ISOSORBIDE DINITRATE~WATSON LABS~5MG **Fe
safety or efficacy reasons**~A~086031~001~~Sep 29, 1987~No~DISCN~WATSON LABORATO
RIES INC
NITROGLYCERIN~TABLET;SUBLINGUAL~NITROSTAT~PFIZER PHARMS~0.3MG~N~021134~001~~May
1, 2000~No~RX~PFIZER PHARMACEUTICALS LTD
1, 2000~No~RX~PFIZER PHARMACEUTICALS LTD
1, 2000~Yes~RX~PFIZER PHARMACEUTICALS LTD
ASENAPINE MALEATE~TABLET;SUBLINGUAL~SAPHRIS~FOREST LABS INC~EQ 5MG BASE~N~022117
~001~~Aug 13, 2009~No~RX~FOREST LABORATORIES INC
ASENAPINE MALEATE~TABLET;SUBLINGUAL~SAPHRIS~FOREST LABS INC~EQ 10MG BASE~N~02211
7~002~~Aug 13, 2009~Yes~RX~FOREST LABORATORIES INC
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~SORBITRATE~ASTRAZENECA~2.5MG~N~016191~002
~~Apr 1, 1996~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
ISOSORBIDE DINITRATE~TABLET;SUBLINGUAL~SORBITRATE~ASTRAZENECA~5MG~N~016191~001~~
Apr 1, 1996~No~DISCN~ASTRAZENECA PHARMACEUTICALS LP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE~TABLET;SUBLINGUAL~SUBOXONE~R
ECKITT BENCKISER~EQ 2MG BASE;EQ 0.5MG BASE~N~020733~001~~Oct 8, 2002~No~DISCN~RE
CKITT BENCKISER PHARMACEUTICALS INC
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE~TABLET;SUBLINGUAL~SUBOXONE~R
ECKITT BENCKISER~EQ 8MG BASE;EQ 2MG BASE~N~020733~002~~Oct 8, 2002~No~DISCN~RECK
ITT BENCKISER PHARMACEUTICALS INC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~SUBUTEX~RECKITT BENCKISER~EQ 2MG B
ASE~N~020732~002~~Oct 8, 2002~No~DISCN~RECKITT BENCKISER PHARMACEUTICALS INC
BUPRENORPHINE HYDROCHLORIDE~TABLET;SUBLINGUAL~SUBUTEX~RECKITT BENCKISER~EQ 8MG B
ASE~N~020732~003~~Oct 8, 2002~No~DISCN~RECKITT BENCKISER PHARMACEUTICALS INC
ERGOTAMINE TARTRATE~TABLET;SUBLINGUAL~WIGRETTES~ORGANON USA INC~2MG~A~086750~001
~~Jul 29, 1982~No~DISCN~ORGANON USA INC
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE~TABLET;SUBLINGUAL~ZUBSOLV~OR
EXO AB~EQ 1.4MG BASE;EQ 0.36MG BASE~N~204242~001~~Jul 3, 2013~No~RX~OREXO AB
EXO AB~EQ 5.7MG BASE;EQ 1.4MG BASE~N~204242~002~~Jul 3, 2013~Yes~RX~OREXO AB
EXO AB~EQ 8.6MG BASE;EQ 2.1MG BASE~N~204242~003~~Dec 11, 2014~No~RX~OREXO AB

EXO AB~EQ 11.4MG BASE;EQ 2.9MG BASE~N~204242~004~~Dec 11, 2014~No~RX~OREXO AB
HYDROCORTISONE~TABLET;VAGINAL~CORTRIL~PFIPHARMECS~10MG~N~009796~001~~Approved Pr
ior to Jan 1, 1982~No~DISCN~PFIPHARMECS DIV PFIZER INC
CLOTRIMAZOLE~TABLET;VAGINAL~GYNE-LOTRIMIN~SCHERING PLOUGH~100MG~N~017717~002~~No
v 30, 1990~Yes~OTC~SCHERING PLOUGH HEALTHCARE PRODUCTS INC
CLOTRIMAZOLE~TABLET;VAGINAL~GYNE-LOTRIMIN 3~BAYER HEALTHCARE LLC~200MG~N~020525~
001~~Jul 29, 1996~Yes~OTC~BAYER HEALTHCARE LLC
CLOTRIMAZOLE~TABLET;VAGINAL~GYNIX~TEVA PHARMS~100MG~A~073249~001~~Feb 13, 1998~N
o~DISCN~TEVA PHARMACEUTICALS USA
NYSTATIN~TABLET;VAGINAL~KOROSTATIN~HOLLAND RANTOS~100,000 UNITS~A~061718~001~~Ap
proved Prior to Jan 1, 1982~No~DISCN~HOLLAND RANTOS CO INC
CLOTRIMAZOLE~TABLET;VAGINAL~MYCELEX-7~BAYER HEALTHCARE LLC~100MG~N~018182~002~~D
ec 26, 1991~No~OTC~BAYER HEALTHCARE LLC
CLOTRIMAZOLE~TABLET;VAGINAL~MYCELEX-G~BAYER PHARMS~500MG~N~019069~001~~Apr 19, 1
NYSTATIN~TABLET;VAGINAL~MYCOSTATIN~DELCOR ASSET CORP~100,000 UNITS~A~060577~001~
~Approved Prior to Jan 1, 1982~No~DISCN~DELCOR ASSET CORP
NYSTATIN~TABLET;VAGINAL~NILSTAT~LEDERLE~100,000 UNITS~A~061325~001~~Approved Pri
or to Jan 1, 1982~No~DISCN~LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
NYSTATIN~TABLET;VAGINAL~NYSTATIN~FOUGERA~100,000 UNITS~A~062459~001~~Nov 9, 1983
~No~DISCN~E FOUGERA DIV ALTANA INC
NYSTATIN~TABLET;VAGINAL~NYSTATIN~ODYSSEY PHARMS~100,000 UNITS~A~062615~001~~Oct
17, 1985~Yes~RX~ODYSSEY PHARMACEUTICALS INC
NYSTATIN~TABLET;VAGINAL~NYSTATIN~PHARMADERM~100,000 UNITS~A~062460~001~~Nov 9, 1
983~No~DISCN~PHARMADERM DIV ALTANA INC
NYSTATIN~TABLET;VAGINAL~NYSTATIN~QUANTUM PHARMICS~100,000 UNITS~A~062509~001~~Ap
r 3, 1984~No~DISCN~QUANTUM PHARMICS LTD
NYSTATIN~TABLET;VAGINAL~NYSTATIN~SANDOZ~100,000 UNITS~A~061965~001~~Approved Pri
NYSTATIN~TABLET;VAGINAL~NYSTATIN~TEVA~100,000 UNITS~A~062502~001~~Dec 23, 1983~N
NYSTATIN~TABLET;VAGINAL~NYSTATIN~WATSON LABS~100,000 UNITS~A~062176~001~~Approve
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)~TABLET;VAGINAL~SULTRIN
~ORTHO MCNEIL PHARM~184MG;143.75MG;172.5MG~N~005794~002~~Approved Prior to Jan 1
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE~TABLET;VAGINAL~TERRAMYCIN-POL
YMYXIN~PFIZER~EQ 100MG BASE;100,000 UNITS~A~061009~001~~Approved Prior to Jan 1,
1982~No~DISCN~PFIZER LABORATORIES DIV PFIZER INC
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)~TABLET;VAGINAL~TRIPLE
SULFA~FOUGERA~184MG;143.75MG;172.5MG~A~088463~001~~Jan 3, 1985~No~DISCN~E FOUGER
A DIV ALTANA INC
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)~TABLET;VAGINAL~TRIPLE
SULFA~PHARMADERM~184MG;143.75MG;172.5MG~A~088462~001~~Jan 3, 1985~No~DISCN~PHARM
ADERM DIV ALTANA INC
ESTRADIOL~TABLET;VAGINAL~VAGIFEM~NOVO NORDISK INC~10MCG~N~020908~002~~Nov 25, 20
09~Yes~RX~NOVO NORDISK INC
ESTRADIOL~TABLET;VAGINAL~VAGIFEM~NOVO NORDISK INC~25MCG~N~020908~001~~Mar 26, 19
CANDICIDIN~TABLET;VAGINAL~VANOBID~SANOFI AVENTIS US~3MG~A~061613~001~~Approved P
rior to Jan 1, 1982~No~DISCN~SANOFI AVENTIS US LLC
GENTIAN VIOLET~TAMPON;VAGINAL~GENAPAX~KEY PHARMS~5MG~A~085017~001~~Approved Prio
r to Jan 1, 1982~No~DISCN~KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP
MICONAZOLE NITRATE~TAMPON;VAGINAL~MONISTAT 5~PERSONAL PRODS~100MG~N~018592~001~~
Oct 27, 1989~No~DISCN~PERSONAL PRODUCTS CO
FLURANDRENOLIDE~TAPE;TOPICAL~CORDRAN~WATSON LABS INC~0.004MG/SQ CM~N~016455~001~
~Approved Prior to Jan 1, 1982~Yes~RX~WATSON LABORATORIES INC
CLOTRIMAZOLE~TROCHE/LOZENGE;ORAL~CLOTRIMAZOLE~PADDOCK LLC~10MG~A~076763~001~AB~O
ct 28, 2005~No~RX~PADDOCK LABORATORIES LLC
CLOTRIMAZOLE~TROCHE/LOZENGE;ORAL~CLOTRIMAZOLE~ROXANE~10MG~A~076387~001~AB~Jul 29
, 2004~Yes~RX~ROXANE LABORATORIES INC
NICOTINE POLACRILEX~TROCHE/LOZENGE;ORAL~COMMIT~GLAXOSMITHKLINE CONS~EQ 2MG BASE~
N~021330~001~~Oct 31, 2002~No~OTC~GLAXOSMITHKLINE CONSUMER HEALTHCARE
NICOTINE POLACRILEX~TROCHE/LOZENGE;ORAL~COMMIT~GLAXOSMITHKLINE CONS~EQ 4MG BASE~
N~021330~002~~Oct 31, 2002~Yes~OTC~GLAXOSMITHKLINE CONSUMER HEALTHCARE
FENTANYL CITRATE~TROCHE/LOZENGE;ORAL~FENTANYL~CEPHALON~EQ 0.1MG BASE~N~020195~00
7~~Oct 30, 1995~No~DISCN~CEPHALON INC
CLOTRIMAZOLE~TROCHE/LOZENGE;ORAL~MYCELEX~BAYER HLTHCARE~10MG~N~018713~001~~Jun 1
7, 1983~No~DISCN~BAYER HEALTHCARE PHARMACEUTICALS INC
NICOTINE POLACRILEX~TROCHE/LOZENGE;ORAL~NICORETTE~GLAXOSMITHKLINE CONS~EQ 2MG BA
SE~N~022360~001~~May 18, 2009~No~OTC~GLAXOSMITHKLINE CONSUMER HEALTHCARE
NICOTINE POLACRILEX~TROCHE/LOZENGE;ORAL~NICORETTE~GLAXOSMITHKLINE CONS~EQ 4MG BA
SE~N~022360~002~~May 18, 2009~Yes~OTC~GLAXOSMITHKLINE CONSUMER HEALTHCARE
NICOTINE POLACRILEX~TROCHE/LOZENGE;ORAL~NICOTINE POLACRILEX~PERRIGO R AND D~EQ 2
MG BASE~A~077007~001~~Jan 31, 2006~No~OTC~PERRIGO R AND D CO
MG BASE~A~077007~002~~Jan 31, 2006~No~OTC~PERRIGO R AND D CO
FENTANYL CITRATE~TROCHE/LOZENGE;TRANSMUCOSAL~ACTIQ~CEPHALON~EQ 0.2MG BASE~N~0207
47~001~AB~Nov 4, 1998~No~RX~CEPHALON INC
47~002~AB~Nov 4, 1998~Yes~RX~CEPHALON INC
FENTANYL CITRATE~TROCHE/LOZENGE;TRANSMUCOSAL~FENTANYL CITRATE~MALLINCKRODT~EQ 0.
2MG BASE~A~078907~001~AB~Oct 30, 2009~No~RX~MALLINCKRODT INC
FENTANYL CITRATE~TROCHE/LOZENGE;TRANSMUCOSAL~FENTANYL CITRATE~PAR

BASE~A~077312~001~AB~Oct 30, 2009~No~RX~PAR PHARMACEUTICAL INC
PHARM~EQ 0.2MG
PHARM~EQ 0.4MG
PHARM~EQ 0.6MG
PHARM~EQ 0.8MG
PHARM~EQ 1.2MG
PHARM~EQ 1.6MG

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Ingredient~DF;Route~Trade_Name~Applicant~Strength~Appl_Type~Appl_No~Product_No~T

METAPROTERENOL SULFATE~AEROSOL, METERED;INHALATION~ALUPENT~BOEHRINGER INGELHEIM~

FLUTICASONE PROPIONATE~AEROSOL, METERED;INHALATION~FLOVENT~GLAXOSMITHKLINE~0.22M

BECLOMETHASONE DIPROPIONATE~AEROSOL, METERED;INHALATION~VANCERIL~SCHERING~0.042M

ns**~N~012731~002~~Approved Prior to Jan 1, 1982~No~DISCN~MERCK AND CO INC

AB~Dec 3, 2004~No~RX~BARR LABORATORIES INC

IDE~DR REDDYS LABS LTD~EQ 20MG BASE~A~090723~001~AB~Dec 11, 2013~No~RX~DR REDDYS

ARMACEUTICALS USA INC

LANSOPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~LANSOPRAZOLE~WOCKHARDT USA~30MG~A

OMEPRAZOLE~CAPSULE, DELAYED REL PELLETS;ORAL~OMEPRAZOLE~MYLAN~20MG~A~075876~002~

022287~001~~Jan 30, 2009~No~RX~TAKEDA PHARMACEUTICALS USA INC

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)~CAPSULE, DELAYED RELEASE;ORAL~PERTZYE~DIG

5MG;2.5MG;2.5MG~N~021303~001~AB~Oct 11, 2001~No~RX~SHIRE DEVELOPMENT INC

CARBAMAZEPINE~CAPSULE, EXTENDED RELEASE;ORAL~CARBATROL~SHIRE~300MG~N~020712~002~

DEXMETHYLPHENIDATE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DEXMETHYLPHENIDA

TE~ABLE~10MG~A~076814~002~~Aug 25, 2004~No~DISCN~ABLE LABORATORIES INC

DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~B

DILTIAZEM HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~DILTIAZEM HYDROCHLORIDE~S

INC~EQ 37.5MG BASE~N~020699~001~AB~Oct 20, 1997~No~RX~WYETH PHARMACEUTICALS INC

TIS~15MG~N~021802~004~AB~Aug 1, 2006~No~RX~NOVARTIS PHARMACEUTICALS CORP

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~IN

MORPHINE SULFATE~CAPSULE, EXTENDED RELEASE;ORAL~KADIAN~WATSON LABS INC~80MG~N~02

ROCHLORIDE~BARR LABS INC~40MG~A~079031~003~AB1~Jul 13, 2012~No~RX~BARR LABORATOR

~30MG~A~202718~002~AB1~Dec 29, 2014~No~RX~TEVA PHARMACEUTICALS USA

MESALAMINE~CAPSULE, EXTENDED RELEASE;ORAL~PENTASA~SHIRE~500MG~N~020049~002~~Jul

PROPRANOLOL HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~PROPRANOLOL HYDROCHLORI

DE~UPSHER SMITH~120MG~A~078311~003~AB~Mar 6, 2009~No~RX~UPSHER SMITH LABORATORIE

~40MG~N~021284~003~AB1~Jun 5, 2002~No~RX~NOVARTIS PHARMACEUTICALS CORP

INC~300MG~A~075401~004~AB4~Apr 10, 2003~No~RX~ACTAVIS LABORATORIES FL INC

THEOPHYLLINE~CAPSULE, EXTENDED RELEASE;ORAL~THEOPHYLLINE~SANDOZ~260MG~A~087462~0

VENLAFAXINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~VENLAFAXINE HYDROCHLORI

MINOCYCLINE HYDROCHLORIDE~CAPSULE, EXTENDED RELEASE;ORAL~XIMINO~RANBAXY LABS LTD

ISOTRETINOIN~CAPSULE;ORAL~ABSORICA~RANBAXY~20MG~N~021951~002~BX~May 25, 2012~No~

No~RX~BARR LABORATORIES INC

VITAMIN A PALMITATE~CAPSULE;ORAL~AFAXIN~STERLING WINTHROP~EQ 50,000 UNITS BASE~A

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE~CAPSULE;ORAL~AMLODIPINE BESYLATE A

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE~CAPSULE;ORAL~AMLODIPINE BESYLATE A

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE~CAPSULE;ORAL~AMLODIPINE BESYLATE A

AMOXICILLIN~CAPSULE;ORAL~AMOXICILLIN~TEVA~250MG~A~063030~001~~Feb 28, 1989~No~DI

G BASE~A~061502~002~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS

FENOFIBRATE~CAPSULE;ORAL~ANTARA (MICRONIZED)~LUPIN ATLANTIS~43MG~N~021695~001~AB

E~N~014684~002~~Approved Prior to Jan 1, 1982~No~DISCN~ELI LILLY AND CO

2007~No~RX~ORIT LABORATORIES LLC

BUSPIRONE HYDROCHLORIDE~CAPSULE;ORAL~BUSPAR~BRISTOL MYERS SQUIBB~15MG~N~021190~0

ior to Jan 1, 1982~No~DISCN~NOVARTIS PHARMACEUTICALS CORP

CELECOXIB~CAPSULE;ORAL~CELEBREX~GD SEARLE~200MG~N~020998~002~AB~Dec 31, 1998~No~

CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~APOTHECON~EQ 500MG BASE~A~063186~002~~Dec 30,

CEPHALEXIN~CAPSULE;ORAL~CEPHALEXIN~TEVA~EQ 500MG BASE~A~062761~001~~Apr 24, 1987

ENOL LABORATORIES INC

S DIV AMERICAN CYANAMID CO

Z~25MG~A~084823~001~~Approved Prior to Jan 1, 1982~No~DISCN~SANDOZ INC

CITALOPRAM HYDROBROMIDE~CAPSULE;ORAL~CITALOPRAM HYDROBROMIDE~MYLAN PHARMS INC~EQ

CLINDAMYCIN HYDROCHLORIDE~CAPSULE;ORAL~CLINDAMYCIN HYDROCHLORIDE~WATSON LABS~EQ

CLOMIPRAMINE HYDROCHLORIDE~CAPSULE;ORAL~CLOMIPRAMINE HYDROCHLORIDE~WATSON LABS~5

CLORAZEPATE DIPOTASSIUM~CAPSULE;ORAL~CLORAZEPATE DIPOTASSIUM~USL PHARMA~15MG~A~0

00USP UNITS;8,000USP UNITS;30,000USP UNITS~N~020580~001~~Dec 9, 1996~No~DISCN~OR

s**~N~020460~002~~Dec 12, 1997~No~DISCN~ROCHE PALO ALTO LLC

10MG~A~089361~001~~Jan 10, 1989~No~DISCN~PIONEER PHARMACEUTICALS INC

DIPHENHYDRAMINE HYDROCHLORIDE~CAPSULE;ORAL~DIPHENHYDRAMINE HYDROCHLORIDE~LNK~25M

MG~A~085874~001~~Approved Prior to Jan 1, 1982~No~DISCN~TEVA PHARMACEUTICALS USA

DISOPYRAMIDE PHOSPHATE~CAPSULE;ORAL~DISOPYRAMIDE PHOSPHATE~MUTUAL PHARM~EQ 150MG

DOXEPIN HYDROCHLORIDE~CAPSULE;ORAL~DOXEPIN HYDROCHLORIDE~MYLAN PHARMS INC~EQ 50M

71487~001~~Mar 2, 1987~No~DISCN~SANDOZ INC

, 2005~No~DISCN~PAR PHARMACEUTICAL INC