180-Day Exclusivity Tracker

180-Day Exclusivity Tracker
LAST UPDATED: 3/14/2013

Drug Abacavir Sulfate Abacavir Sulfate/ Lamivudine Abacavir sulfate, Lamivudine and Zidovudine Dosage Form Tablets Tablets Strength 300 mg 600 mg; 300 mg 300 mg/150 mg/300 mg RLD ZIAGEN EPZICOM Date of Submission 1/28/2009 9/27/2007 ANDA Approval Date 6/18/2012 Approval Letter Exclusivity Decision
ANDA No. Exclusivity Granted (Expiration 12/16/2012) 091294 Tentative Approval(s) Granted
Tablets
TRIZIVIR
3/22/2011 Exclusivity Forfeited - Failure to Market (FDC Act ANDA No. 505(j)(5)(D)(i)(I)) 077532 FDA Letter Decision
Acarbose
Tablets
25 mg, 50 mg & 100 mg
PRECOSE
3/22/2005
5/7/2008
Acetaminophen
Injection
1000 mg/100 mL (10 mg/mL)
OFIRMEV
4/7/2011 Exclusivity Granted (Pre-MMA) (Expiration 11/12/2000)
Acetaminophen
Extended-release Tablets
650 mg
TYLENOL
Prior to 12/8/2003 Prior to 12/8/2003 Prior to 12/8/2003
2/25/2000
ANDA No. 075077 ANDA No. 076475 ANDA No. 075794 Exclusivity Granted (Pre-MMA) (Expiration 10/18/2005)
Acetaminophen/Tramado Tablets l Hydrochloride Acetaminophen/Aspirin/C Tablets affeine
325 mg/37.5 mg 250 mg/250 mg/65 mg
ULTRACET
4/21/2005
Exclusivity Granted (Pre-MMA) EXCEDRIN (Migraine) 11/26/2001
Drug
Dosage Form
Strength 6 gm/30 mL (200mg/mL) 50 mg/mL, 10 mL and 20 mL vials 0.30%
RLD
Date of Submission After 12/8/2003 Prior to 12/8/2003
ANDA Approval Date 11/7/2012
Approval Letter ANDA No. 200644
Exclusivity Decision Exclusivity Granted (Expiration 5/29/2013)
Acetylcysteine
Injection
ACETADOTE
No Exclusivity Granted (Pre-MMA) ZOVIRAX
Acyclovir Sodium
Injection
Adapalene Adapalene and Benzoyl Peroxide Adefovir Dipivoxil
Topical Gel
DIFFERIN
9/15/2009
6/14/2012
ANDA No. 200298
Exclusivity Granted
Gel
0.1%/2.5%
EPIDUO
12/30/2011
Tablets
10 mg 3 mg/mL, 20 mL and 30 mL vials 2 mg(base)/5 mL 4 mg and 8 mg
HEPSERA
6/8/2010
Adenosine
Injection
ADENOSCAN
4/16/2005 Prior to 12/8/2003 Exclusivity Granted (Pre-MMA) Prior to 12/8/2003 9/30/2002 ANDA No. 076130 ANDA No. 077772 ANDA No. 076355 ANDA No. 076867 Exclusivity Granted
Albuterol Sulfate
Oral Syrup Extended-release Tablets
VENTOLIN
Albuterol Sulfate
VOLMAX
Albuterol Sulfate
Inhalation Solution
0.021%
ACCUNEB
10/19/2005 Prior to 12/8/2003 Prior to 12/8/2003
9/25/2007
Exclusivity Granted (Pre-MMA)
Albuterol Sulfate
Inhalation Solution
0.042%
ACCUNEB
6/28/2004
Exclusivity Granted (Pre-MMA) (Expiration 12/29/2007) Albuterol Sulfate/ Ipratropium Bromide Inhalation Solution 0.083%/0.017 % DUONEB 12/21/2006
Albuterol Sulfate
Inhalation Aerosol
0.09 mg base per actuation
PRO-AIR HFA
5/18/2012
Drug
Dosage Form
Strength
RLD
Date of Submission 9/7/2007
ANDA Approval Date
Approval Letter
Exclusivity Decision
Alendronate Sodium
Oral Solution
70 mg/75 mL
FOSAMAX
2/6/2008 Alendronate Sodium Tablets 5 mg, 10 mg, 35 mg, 40 mg and 70 mg FOSAMAX Prior to 12/8/2003 2/6/2008
Exclusivity Granted (Pre-MMA) (Expiration 8/4/2008) (Sole Exclusivity - 5 mg, 10 mg, 35 mg, and 40 mg ; ANDA No. Shared Exclusivity - 70 mg) 075710 Exclusivity Granted (Pre-MMA) ; (Expiration 8/4/2008) ANDA No. (Shared Exclusivity on 70 mg strength) 076184
Alendronate Sodium and Tablets Cholecalciferol
70 mg/2800 IU and 70 mg/5600 IU
FOSAMAX PLUS D
11/20/2007
7/18/2011
ANDA No. 079013 ANDA No. 079014 ANDA No. 079054 ANDA No. 079056 ANDA No. 079057
Exclusivity Granted (Shared) (Expiration 1/14/2012)
7/18/2011
Alfuzosin Hydrochloride
10 mg
UROXATRAL
6/12/2007
7/18/2011
7/18/2011
7/18/2011
Almotriptan Malate
Tablets
6.25 mg and 12.5 mg
Tentative Approval(s) Granted AXERT 12/8/2005
Drug Alosetron Hydrochloride
Dosage Form Tablets
Strength 0.5 mg and 1 mg
RLD LOTRONEX
ANDA Approval Date
Approval Letter
Alprazolam
0.25 mg, 0.5 Orally Disintegrating mg, 1 mg and Tablets 2 mg 0.25 mg, 0.5 mg, 1 mg and 2 mg
Exclusivity Granted (Expiration 7/13/2009) NIRAVAM 12/27/2005 1/9/2009 ANDA No. 078088
Alprazolam
Tablets
XANAX
Prior to 12/8/2003 Exclusivity Granted (Expiration 9/23/2008)
Amifostine
For Injection
500 mg/vial
ETHYOL
4/16/2004
3/14/2008
ANDA No. 077126 Exclusivity Granted (Pre-MMA) (Expiration 3/25/2007; Patent Expiration)
Amlodipine Besylate
Tablets
2.5 mg, 5 mg and 10 mg
NORVASC
Prior to 12/8/2003
10/3/2005
ANDA No. 076418
FDA Letter Decision 1 FDA Letter Decision 2 FDA Letter Decision 3
Amlodipine Besylate and Tablets Atorvastatin Calcium
2.5 mg/10 mg, 2.5 mg/20 mg and 10 mg/40 mg
CADUET
9/17/2009
2.5 mg/40 mg
CADUET
9/17/2009
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg
CADUET
12/29/2006
5 mg/80 mg
CADUET
4/7/2009 Exclusivity Granted (Expiration 11/14/2007)
Amlodipine Besylate and Capsules Benazepril Hydrochloride
2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg 5 mg/40 mg and 10 mg/40 mg 5 mg/20 mg and 10 mg/40 mg 10 mg/20 mg and 5 mg/40 mg
LOTREL
6/9/2004
5/18/2007
ANDA No. 077179
Exclusivity Granted (Expiration 7/2/2011) LOTREL 11/17/2006 7/29/2010 ANDA No. 078381 Tentative Approval(s) Granted AZOR 2/11/2008 Tentative Approval(s) Granted AZOR 3/31/2008 Tentative Approval(s) Granted
Amlodipine Besylate and Capsules Benazepril Hydrochloride
Amlodipine Besylate and Tablets Olmesartan Medoxomil
Amlodipine Besylate and Tablets Olmesartan Medoxomil
Amlodipine Besylate and Tablets Valsartan
5 mg/160 mg
EXFORGE
10/22/2007 Tentative Approval(s) Granted
5 mg/320 mg
EXFORGE
11/26/2007
Drug
Dosage Form
Strength
RLD
ANDA Approval Date
Approval Letter
Exclusivity Decision Tentative Approval(s) Granted
10 mg/160 mg
EXFORGE
Tentative Approval(s) Granted Amlodipine Besylate and Tablets Valsartan 10 mg/320 mg EXFORGE 11/9/2007 Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) EXFORGE HCT 9/14/2009 9/25/2012 ANDA No. 200435
Amlodipine, Hydrochlorothiazide and Valsartan
Tablets
5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg
Amlodipine, Hydrochlorothiazide and Valsartan Amoxicillin and Clavulanate Potassium
Exclusivity Granted Tablets 10 mg/12.5 mg/160 mg EXFORGE HCT 10/22/2009 9/25/2012 ANDA No. 200435 Exclusivity Granted Extended-release Tablets 1000 mg/62.5 mg AUGMENTIN XR 1/21/2009 4/21/2010 ANDA No. 090227
Aprepitant
Capsule
40 mg, 80 mg and 125 mg
EMEND
11/3/2008
9/24/2012
ANDA No. 090999
Arformoterol Tartrate
Inhalation Solution
Eq. 0.015 mg base/2 mL
BROVANA
Argatroban
Injection
100 mg/mL, 2.5 mL vials
ARGATROBAN
9/24/2007
Argatroban in Sodium Chloride
Injection
1 mg/mL, 50 mL vials
ARGATROBAN
12/16/2011
Drug
Dosage Form
Strength
RLD
ANDA Approval Date
Approval Letter
Aripiprazole
Oral Solution
1 mg/mL
ABILIFY
Aripiprazole
Tablets
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
ABILIFY
Aripiprazole
10 mg, 15 mg, Orally Disintegrating 20 mg and 30 Tablets mg 50 mg, 150 mg and 250 mg
ABILIFY
11/15/2006 Exclusivity Granted
Armodafinil
Tablets
NUVIGIL
7/24/2009
6/1/2012
ANDA No. 200043 Tentative Approval(s) Granted
Armodafinil
Tablets
100 mg
NUVIGIL
Armodafinil
Tablets
200 mg
NUVIGIL
9/3/2009 Exclusivity Granted/Forfeited (180-Day Punt) - Failure ANDA No. to Obtain Tentative Approval in 30 Months (FDC Act 078804 505(j)(5)(D)(i)(IV)) Tentative Approval(s) Granted
Extended-release Aspirin and Dipyridamole Capsules
25 mg and 200 mg
AGGRENOX
2/1/2007
8/14/2009
Atazanavir Sulfate
Capsules
100 mg and 150 mg
REYATAZ
Atazanavir Sulfate
Capsules
200 mg
REYATAZ
Atazanavir Sulfate
Capsules
300 mg
REYATAZ
7/20/2009
Drug
Dosage Form
Strength 25 mg, 50 mg and 100 mg 50 mg/25 mg and 100 mg/25 mg
RLD
Date of Submission Prior to 12/8/2003
ANDA Approval Date
Approval Letter
Atenolol
Tablets
TENORMIN
Atenolol/ Chlorthalidone
Tablets
TENORETIC
Prior to 12/8/2003
Atovaquone
Oral Suspension
750 mg/5 mL
MEPRON
10/20/2009
Atovaquone and Proguanil Hydrochloride
Tablets
62.5 mg/25 mg
MALARONE
Atovaquone and Proguanil Hydrochloride
Tablets
250 mg/100 mg
MALARONE
4/3/2009
1/12/2011
ANDA No. 091211 Exclusivity Granted
8/30/2010
8/30/2010
ANDA No. 079021 Exclusivity Forfeited (Failure to Obtain Tentative ANDA No. Approval in 30 Months - FDC Act 505(j)(5)(D)(i)(IV)) 078940 Exclusivity Granted
8/30/2010 10 mg, 18 mg, 25 mg, 40 mg, STRATTERA 60 mg, 80 mg and 100 mg
Atomoxetine Hydrochloride
Capsules
5/29/2007
9/13/2010
9/16/2010
ANDA No. 079017
Hydrochloride
Capsules
60 mg, 80 mg and 100 mg
STRATTERA
5/29/2007
Drug
Dosage Form
Strength
RLD
Date of Submission
Exclusivity Decision Exclusivity Granted
Exclusivity Granted 10/1/2010 ANDA No. 079022 Exclusivity Granted (Pre-MMA) (Expiration 5/28/2012) LIPITOR Prior to 12/8/2003 11/30/2011 ANDA No. 076477
Atorvastatin Calcium
Tablets
10 mg, 20 mg, 40 mg and 80 mg
Azelaic Acid
Gel
15%
FINACEA
Azelastine Hydrochloride Nasal Spray
0.125 mg base/spray
ASTELIN
11/14/2005
4/30/2009
ANDA No. 077954 Tentative Approval(s) Granted
Azelastine Hydrochloride Nasal Spray
205.5 mcg/spray
ASTEPRO
Azelastine Hydrochloride Ophthalmic Solution 0.05%
OPTIVAR
12/13/2006
8/3/2009
ANDA No. 078621
Azithromycin
For Injection
500 mg/vial
ZITHROMAX
6/17/2011
Azithromycin
Ophthalmic Solution 1.00%
AZASITE
3/3/2011 Exclusivity Granted (Expiration 11/7/2009) 3/24/2009 ANDA No. 065506
Azithromycin
Injection
500 mg base/vial
ZITHROMAX
On or After 12/8/2003
Drug Azithromycin
Dosage Form Injection
Strength 500 mg base/vial
RLD ZITHROMAX
Date of On or After Submission 12/8/2003
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter

Drug Dosage Form Strength 0.12% RLD LUXIQ Date of Submission 8/10/2007 Prior to 12/8/2003 6/6/2011 4/5/2011 12/22/2008 5/3/2010 9/1/2009 11/20/2008 12/20/2006 ANDA Approval Date 11/26/2012 Approval Letter ANDA No. 078337
Betamethasone Valerate Foam
Betaxolol Bexarotene Bimatoprost Bimatoprost Bimatoprost Bivalirudin Bortezomib Brimonidine Tartrate
Ophthalmic Solution 0.5%(base) Capsules 75 mg
BETOPTIC TARGRETIN LUMIGAN LUMIGAN LATISSE ANGIOMAX VELCADE ALPHAGAN P
Ophthalmic Solution 0.01% Ophthalmic Solution 0.03% Topical Solution For Injection For Injection 0.03% 250 mg/vial 3.5 mg/vial
Brimonidine Tartrate
ALPHAGAN P
11/3/2006 Prior to 12/8/2003 11/21/2008 2/1/2008 5/16/2011 ANDA No. 090410 ANDA No. 076260
Brimonidine Tartrate
ALPHAGAN COMBIGAN ENTOCORT EC
5/28/2003
Brimonidine Tartrate and Ophthalmic Solution 0.2%/0.5% Timolol Maleate Budesonide Enteric Coated Capsules 3 mg
Drug Budesonide
Dosage Form Nasal Spray Inhalation Suspension
Strength 0.032 mg (32 mcg)/spray 0.25 mg/2 mL and 0.5 mg/2 mL
RLD RHINOCORT PULMICORT RESPULES
ANDA Approval Date
Approval Letter
Budesonide
9/15/2005
11/18/2008
ANDA No. 077519
Budesonide
Inhalation Suspension Extended-release Tablets Extended-release Tablets Extended-release Tablets
1 mg/2 mL
PULMICORT RESPULES APLENZIN
5/28/2010
Bupropion Hydrobromide
174 mg
9/28/2009
348 mg
APLENZIN
9/24/2009
522 mg
APLENZIN
12/24/2009
Bupropion Hydrochloride
100 mg, 150 mg and 200 mg
WELLBUTRIN SR
Prior to 12/8/2003 12/3/2004 ANDA No. 076711
Bupropion Hydrochloride
150 mg
ZYBAN
Prior to 12/8/2003
9/21/2004 Bupropion Hydrochloride Extended-release Tablets 150 mg and 300 mg WELLBUTRIN XL On or After 12/8/2003
12/14/2006
ANDA No. 077284
12/15/2006
ANDA No. 077415
Drug
Dosage Form
Strength 75 mg and 100 mg
RLD WELLBUTRIN
ANDA Approval Date
Approval Letter
Bupropion Hydrochloride Tablets
3/28/2001
ANDA No. 074253
3/28/2001 Buspirone Hydrochloride Tablets 5 mg, 7.5 mg, 10 mg, 15 mg and 30 mg BUSPAR Prior to 12/8/2003 3/28/2001
ANDA No. 075272
ANDA No. 075467
6/28/2001
ANDA No. 076008
Butoconazole Nitrate
Vaginal Cream
2%
GYNAZOLE-1
12/23/2009
5/18/2012
ANDA No. 200923
Butorphanol Tartrate
Nasal Spray
10 mg/mL
STADOL NS
Prior to 12/8/2003
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Decision Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
Tentative Approval(s) Granted
Exclusivity Forfeited (Application Withdrawn (FDC Act 505(j)(5)(D)(i)(II))
Exclusivity Granted (Pre-MMA) (Expiration 9/16/2003) Tentative Approval(s) Granted Exclusivity Presumably Granted
No Exclusivity Granted
Exclusivity Presumably Selectively Waived (PreMMA) (100 mg) Exclusivity Relinquished (Pre-MMA) (150 mg) See ANDA No. 075932 Exclusivity Granted (Pre-MMA) (200 mg)
Exclusivity Relinquished (Pre-MMA) Exclusivity Granted (Expiration 6/12/2007; 300 mg; Exclusivity Selectively Waived) (Expired 11/26/2008; 150 mg)
Exclusivity Granted (Expiration 6/12/2007; 300 mg; Exclusivity Selectively Waived)
Exclusivity Granted (Pre-MMA) (Expiration 9/26/2001; 5 mg & 10 mg) Exclusivity Granted (Pre-MMA) (Expiration 9/24/2001; 15 mg)
Exclusivity Granted (Pre-MMA) (Expiration 9/26/2001; 7.5 mg strength)
Exclusivity Granted (Pre-MMA) (Expiration 1/28/2002; 30 mg)
Exclusivity Granted (Expiration 5/14/2013)
No Exclusivity Presumably Granted (Pre-MMA)

Drug Calcipotriene Dosage Form Topical Cream Strength 0.005% RLD DOVONEX Date of Submission 12/2/2009 ANDA No. 078305 ANDA Approval Date Approval Letter
Calcipotriene
Topical Solution
0.005%
DOVONEX
5/19/2006
5/6/2008
Calcipotriene and Betamethasone Dipropionate Calcitonin-Salmon Calcitonin-Salmon (Recombinant)
Ointment
0.005%/0.064 % 200 IU/spray 200 IU/spray
TACLONEX
3/31/2010 Prior to 12/8/2003 3/29/2006
1/14/2013
ANDA No. 201615 ANDA No. 076396
Nasal Spray Nasal Spray
MIACALCIN FORTICAL
11/17/2008
2/20/2003
ANDA No. 075766
Calcitriol
Injection
1 mcg/mL and 2 mcg/mL, 1 mL vials
CALCIJEX
Prior to 12/8/2003
3/31/2003
ANDA No. 075823
12/31/2002
ANDA No. 075836
Calcium Acetate
Capsules
EQ 169 mg calcium
PHOSLO
5/31/2005
2/26/2008
ANDA No. 077728
Drug Calcium Carbonate/ Famotidine/ Magnesium Hydroxide Candesartan Cilexetil
Dosage Form
Strength 800 mg/ 10 mg/ 165 mg (OTC) 4 mg, 8 mg, 16 mg and 32 mg 16 mg/12.5 mg and 32 mg/12.5 mg 32 mg/25 mg 150 mg and 500 mg 12.5 mg, 25 mg, 50 mg, and 100 mg 100 mg and 200 mg 200 mg and 300 mg
RLD
Chewable Tablets
PEPCID COMPLETE
Tablets
ATACAND
12/22/2006
Candesartan Cilexetil and Tablets Hydrochlorothiazide Candesartan Cilexetil and Tablets Hydrochlorothiazide Capecitabine Tablets
ATACAND HCT
6/25/2008
12/4/2012
ANDA No. 090704 ANDA No. 090704
ATACAND HCT
3/6/2009
12/4/2012
XELODA
11/10/2008 Prior to 12/8/2003
Captopril
Tablets
CAPOTEN
Carbamazepine
Extended-release Capsules Extended-release Capsules
CARBATROL
2/2/2006
Carbamazepine
EQUETRO
8/21/2007
Carbamazepine
Extended-release Capsules
300 mg
CARBATROL
Prior to 12/8/2003
5/20/2011
ANDA No. 076697
Carbamazepine
100 mg
TEGRETOL-XR
12/30/2005
3/31/2009
ANDA No. 078115
Carbamazepine
200 mg and 400 mg
TEGRETOL-XR
Prior to 12/8/2003
Drug Carbidopa, Levodopa and Entacapone
Dosage Form
Strength 12.5 mg, 50 mg and 200 mg 18.75 mg/75 mg/200 mg and 31.25 mg/125 mg/200 mg 25/100/200 mg and 37.5/150/200 mg 50 mg/200 mg/200 mg 25 mg/100 mg and 50 mg/200 mg 50 mg/vial, 150 mg/vial and 450 mg/vial 50 mg/vial, 150 mg/vial and 450 mg/vial 200 mg/ 325 mg 200 mg/ 325 mg/ 16 mg 3.125 mg, 6.25 mg, 12.5 mg and 25 mg 10 mg and 20 mg 40 mg
RLD
ANDA Approval Date
Approval Letter
Tablets
STALEVO 50
Carbidopa, Levodopa and Entacapone
Tablets
STALEVO 75 AND STALEVO 125
5/19/2009
Carbidopa, Levodopa and Entacapone Carbidopa, Levodopa and Entacapone Carbidopa/ Levodopa
Tablets
STALEVO 100 AND STALEVO 150
6/29/2007
Tablets Extended-release Tablets
STALEVO 200
8/28/2008 Prior to 12/8/2003
SINEMET CR
Carboplatin
For Injection
PARAPLATIN
Prior to 12/8/2003
Carboplatin
Injection
PARAPLATIN
Prior to 12/8/2003 Prior to 12/8/2003 Prior to 12/8/2003 Prior to 12/8/2003
Carisoprodol/ Aspirin Carisoprodol/ Aspirin/ Codeine
Tablets Tablets
SOMA COMPOUND SOMA COMPOUND WITH CODEINE
Carvedilol
Tablets
COREG
Carvedilol Phosphate Carvedilol Phosphate
COREG CR COREG CR
3/18/2008 12/21/2007
Drug Carvedilol Phosphate
Dosage Form Extended-release Capsules For Injection
Strength 80 mg 50 mg/vial and 70 mg/vial 50 mg 100 mg, 200 mg and 400 mg 5 mg/5 mL
RLD COREG CR
ANDA Approval Date
Approval Letter
Caspofungin Acetate
CANCIDAS
6/26/2009
Celecoxib
Capsules
CELEBREX
3/21/2008 Likely PreMMA 3/19/2007
Celecoxib
Capsules
CELEBREX
Cetirizine Hydrochloride
Syrup
ZYRTEC
Cetirizine Hydrochloride
Chewable Tablets
5 mg and 10 mg (OTC)
ZYRTEC
3/25/2005
1/11/2008
ANDA No. 077631
Cetirizine Hydrochloride and Pseudoephedrine
5 mg/120 mg
ZYRTEC-D
6/2/2004
2/25/2008
ANDA No. 077170
Cevimeline Hydrochloride Capsules
30 mg
EVOXAC
2/27/2009 Prior to 12/8/2003 9/10/2004
8/25/2011
ANDA No. 091260
Chlorhexidine Gluconate Scrub brush/sponge 4% Chlorpheniramine Polistirex and Hydrocodone Polistirex Ciclesonide Extended-release Capsules 8 mg/10 mg and 4 mg/5 mg
HIBICLENS
TUSSIONEX
Nasal Spray
250 mcg
OMNARIS
2/13/2012 ANDA No. 078266
Ciclopirox
Gel
0.77%
LOPROX
5/10/2006
1/7/2009
Drug
Dosage Form
Strength 30 mg, 60 mg and 90 mg 250 mg/5 mL and 500 mg/ 5 mL 100 mg, 250 mg, 500 mg and 750 mg
RLD
ANDA Approval Date
Approval Letter
Cinacalcet Hydrochloride Tablets
SENSIPAR
Ciprofloxacin
Oral Suspension
CIPRO
10/16/2009
Ciprofloxacin Hydrochloride
Tablets
CIPRO
Prior to 12/8/2003
6/9/2004
ANDA No. 075593
Ciprofloxacin Hydrochloride
500 mg
CIPRO XR
11/30/2010
ANDA No. 077417
Ciprofloxacin Hydrochloride Cisatracurium Besylate
Extended-release Tablets (multi-dose) Injection (preserve free) Injection
1000 mg 2 mg/mL, 10 mL vial 2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial 1 mg/mL, 10 mL, 50 mL, 100 mL and 200 mL vials
CIPRO XR
On or After 12/8/2003 8/12/2009
11/30/2010
ANDA No. 077809
NIMBEX
Cisatracurium Besylate
NIMBEX
8/4/2009
Cisplatin
Injection
PLATINOL-AQ
Prior to 12/8/2003
7/16/1999
ANDA No. 074735
Cisplatin
For Injection
10 mg/vial and 50 mg/vial
PLATINOL
Prior to 12/8/2003
Clarithromycin
Extended-release Tablet
500 mg
BIAXIN XL
12/6/2010
Drug
Dosage Form
Strength
RLD
Date of Submission PIV received prior to 2/5/2009
Clindamycin Phosphate
Foam
1%
EVOCLIN
Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Tretinoin Clobetasol Propionate
Gel
1% / 5%
DUAC
12/11/2008
Gel
1.2%/0.025%
ZIANA
12/17/2010
6/26/2012
ANDA No. 090979 ANDA No. 201402 ANDA No. 077763
Emulsion Foam
0.05%
OLUX-E
2/25/2010
8/14/2012
Clobetasol Propionate
Topical Foam
0.05%
OLUX
6/27/2005
3/10/2008
Lotion
0.05%
CLOBEX
3/27/2006
12/4/2008
Spray
0.05%
CLOBEX
9/29/2008
6/16/2011
Topical Shampoo
0.05%
CLOBEX
1/9/2008
6/7/2011
Clofarabine
Injection Extended-release Tablets Extended-release Tablets Transdermal System
1 mg/mL, 20 mL vial 0.1 mg and 0.2 mg 0.1 mg and 0.2 mg 0.1 mg/day, 0.2 mg/day, and 0.3 mg/day
CLOLAR
2/23/2012
Clonidine hydrochloride Clonidine hydrochloride
KAPVAY JENLOGA
3/4/2011 3/4/2011
Clonidine Hydrochloride
CATAPRES-TTS
Prior to 12/8/2003
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date 1/20/2006 (6/22/2009 Converted to a Tentative Approval)
Approval Letter
ANDA No. 076274
Clopidogrel Bisulfate
Tablets
75 mg
PLAVIX
Prior to 12/8/2003
5/17/2012
ANDA No. 077665
Clopidogrel Bisulfate
Tablets
300 mg
PLAVIX
3/4/2009
5/17/2012
ANDA No. 091023
Clozapine
Orally Disintegrating 12.5 mg Tablets Orally Disintegrating 25 mg and 100 Tablets mg Orally Disintegrating 150 mg Tablets Orally Disintegrating 200 mg Tablets Tablets 0.6 mg 1.875 g/Packet and 3.75 g/Packet 625 mg
FAZACLO
6/5/2008
Clozapine
FAZACLO
4/28/2008
Clozapine
FAZACLO
4/8/2011
Clozapine
FAZACLO
4/18/2011
Colchicine
COLCRYS
12/23/2011
Colesevelam Hydrochloride Colesevelam Hydrochloride
Powder for Oral Suspension Tablets
WELCHOL
4/9/2010
WELCHOL
7/1/2009
Colestipol Hydrochloride
Tablets
1g
COLESTID
8/23/2005
10/24/2006
ANDA No. 077510
Drug Conjugated Estrogen (Synthetic A) Conjugated Estrogen (Synthetic A) Conjugated Estrogen (Synthetic A) Conjugated Estrogens Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride
Dosage Form Tablets
Strength 0.3 mg, 0.45 mg and 0.9 mg 1.25 mg 0.625 mg 0.3 mg and 0.625 mg 10 mg 15 mg and 30 mg 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial and 2
RLD CENESTIN
ANDA Approval Date
Approval Letter
Tablets Tablets
CENESTIN CENESTIN
11/3/2008 3/2/2009 Prior to 12/8/2003 Prior to 12/8/2003 8/11/2008 2/29/1988 ANDA No. 071611 ANDA No. 090738
Tablets
PREMARIN
Tablets Extended-release Capsule
FLEXERIL
AMRIX
4/18/2011
Cyclophosphamide
For Injection
CYTOXAN
Prior to 12/8/2003
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Granted
Exclusivity Granted (Pre-MMA; Shared) (Expiration 9/17/2003)
Exclusivity Granted
Exclusivity Decision Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Tentative Approval(s) Granted
Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted
Exclusivity Forfeited FDA Letter Decsion Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Pre-MMA) (Expiration 11/16/2011) FDA Letter Decsion Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Presumably No Exclusivity Granted (Pre-MMA)
Exclusivity Decision Exclusivity Granted (Exclusivity Believed to Have Been Triggered By Authorized Generic Marketing) Exclusivity Granted (Exclusivity Believed to Have Been Triggered By Authorized Generic Marketing)
Exclusivity Granted (Exclusivity Believed to Have Been Triggered By Authorized Generic Marketing)
Exclusivity Granted (Exclusivity Believed to Have Been Triggered By Authorized Generic Marketing) No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
Tentative Approval(s) Granted Tentative Approval(s) Granted
No Exclusivity Granted (Presumably Forfeited) Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Expiration 2/5/2005) (Only with respect to 100 mg; FDA determined 250 mg, 500 mg and 750 mg "are ineligible for 180-day exclusivity") Exclusivity Granted
Exclusivity Granted
Exclusivity Granted - (Expiration 5/15/2000) FDA Decision - Docket No. FDA-1999-P-0058 (formerly Docket No. 1999P-1271) (Aug. 2, 1999))
Exclusivity Decision Exclusivity Granted (QI Act) (Expiration 9/27/2010)
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Expiration 7/31/2013) Exclusivity Granted (Expiration 9/16/2008)
Exclusivity Granted Exclusivity Granted (Expiration 6/30/2012) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV))
No Exclusivity Presumably Granted
Exclusivity Decision Exclusivity Granted (Pre-MMA) (Expiration 2/4/2007)
Exclusivity Granted (Pre-MMA) (Expiration 11/13/2012)
No Exclusivity Granted (Pre-MMA) No ANDAs for this drug; see FDA Decision Exclusivity Granted (Pre-MMA) - (Expiration 11/15/1989) Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV))

Drug Daptomycin Darifenacin Hydrobromide Dosage Form For Injection Extended-release Tablets Strength 500 mg/vial 7.5 mg and 15 mg 75 mg, 150 mg, 300 mg, 400 mg and 600 mg 80 mg and 140 mg 20 mg, 50 mg, 70 mg and 100 mg 125 mg, 250 mg, and 500 mg 99.90% RLD CUBICIN Date of Submission 11/19/2008 Tentative Approval(s) Granted ENABLEX 12/22/2008 ANDA Approval Date Approval Letter Exclusivity Decision
Darunavir Ethanolate
Tablets
PREZISTAS
6/23/2010
Dasatinib
Tablets
SPRYCEL
6/17/2011
Dasatinib
Tablets
SPRYCEL
6/28/2010
Deferasirox
Tablets
EXJADE
10/28/2011
Desflurane
Inhalation
SUPRANE
9/11/2008 Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)); All First Applicants Forfeited (Mass Forfeiture) See ANDA No. 078357 Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
Desloratadine
Tablets
5 mg
CLARINEX
6/21/2006
Desloratadine
Orally Disintegrating 2.5 mg and 5 Tablets mg
CLARINEX
6/21/2006
Drug Desloratadine
Orally Disintegrating 2.5Strength mg and 5 Dosage Form Tablets mg
RLD CLARINEX
Date of 6/21/2006 Submission
ANDA Approval Date
Approval Letter
Exclusivity Decision See ANDA No. 078367
Desloratadine
Oral Solution
0.5 mg/mL
CLARINEX SYRUP CLARINEX-D 24 HOUR
5/8/2008
Desloratadine and Extended-release Pseudoephedrine Sulfate Tablets
2.5 mg/120 mg
6/1/2007 Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)); All First Applicants Forfeited (Mass Forfeiture) See ANDA No. 078366
Desloratadine and Extended-release Pseudoephedrine Sulfate Tablets
5 mg/240 mg
CLARINEX-D 24 HOUR
6/21/2006
Desmopressin Acetate
Injection
4 mcg/mL, 1 mL and 10 mL vials 0.01%
DDAVP
Prior to 12/8/2003 Prior to 12/8/2003 Prior to 12/8/2003 ANDA No. 076470 Exclusivity Granted (Pre-MMA) (Expiration 6/4/2002) No Exclusivity Granted (Pre-MMA) Exclusivity Granted (Pre-MMA) (Expiration 12/28/2005)
Nasal Spray
DDAVP
Tablets
0.1 mg and 0.2 mg
DDAVP
7/1/2005
Desogestrel; Ethinyl Estradiol
Tablets
0.15mg/ 0.02 mg and 0.01 mg
MIRCETTE
Prior to 12/8/2003
4/5/2002
ANDA No. 075863
Desonide
Gel
0.05%
DESONATE
12/1/2010
Desvenlafaxine Succinate
50 mg and 100 mg
PRISTIQ
2/29/2012
Dexlansoprazole
Delayed-release Capsule
30 mg
DEXILANT
11/30/2010
Drug
Dosage Form Delayed-release Capsule
Strength
RLD
ANDA Approval Date
Approval Letter
Dexlansoprazole
60 mg
DEXILANT
Tentative Approval(s) Granted Dexmedetomidine Injection 100 mcg/mL PRECEDEX 4/8/2009 Exclusivity Granted (Expiration 12/3/2007) Dexmethylphenidate Hydrochloride Tablets 2.5 mg FOCALIN 7/27/2004 1/29/2007 ANDA No. 077107 Exclusivity Granted (Expiration 12/3/2007) Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Dexmethyphenidate Hydrochloride Dexmethylphenidate Dexmethylphenidate Tablets 5 mg and 10 mg FOCALIN 5/27/2004 1/29/2007 ANDA No. 077107
Extended-release Capsules Extended-release Capsules Extended-release Capsule Extended-release Capsule Extended-release capsules Extended-release capsules
15 mg 5 mg, 10 mg and 20 mg 30 mg 40 mg 25 mg 35 mg 250 mg/vial, and 500 mg/vial
FOCALIN XR FOCALIN XR FOCALIN XR FOCALIN XR FOCALIN XR FOCALIN XR
5/14/2007 3/30/2007 Tentative Approval(s) Granted 12/15/2010 12/20/2010 9/30/2011 9/29/2011 Exclusivity Granted (Pre-MMA) (Expiration 8/27/2005; ANDA No. 250 mg/vial) (Expiration 10/19/2005; 500 mg/vial) 076068 Exclusivity Granted (Expiration 8/4/2008; 5 mg)
Dexrazoxane
For Injection
ZINECARD
Prior to 12/8/2003
9/28/2004
Dextroamphetamine saccharate; Amphetamine aspartate; Extended-release Dextroamphetamine Capsules Sulfate; Amphetamine Sulfate
8/25/2004 ADDERALL XR Prior to 12/8/2003
ANDA No. 076814
Dextroamphetamine saccharate; Amphetamine aspartate; Extended-release Drug Dosage Form Dextroamphetamine Capsules Sulfate; Amphetamine Sulfate
5 mg, 10 mg, 15 Strength mg, 20 mg, 25 mg and 30 mg
RLD ADDERALL XR
Date of Prior to Submission 12/8/2003
ANDA Approval Date
Approval Letter
Exclusivity Decision A period of 180-day exclusivity was triggered by the launch of an authorized generic.
Dextroamphetamine saccharate; Amphetamine aspartate; Tablets Dextroamphetamine Sulfate; Amphetamine Sulfate Dextroamphetamine saccharate; Amphetamine aspartate; Tablets Dextroamphetamine Sulfate; Amphetamine Sulfate Dextromethorphan Polistirex Dextromethorphan Hydrobromide and Quinidine Sulfate Diazepam Extended-release Suspension Capsules
5 mg, 10 mg, 20 mg, 30 mg
ADDERALL 30
11/18/2009
Exclusivity Granted (Pre-MMA) (Expiration 9/15/2003) 7.5 mg, 12.5 mg and 15 mg Prior to 12/8/2003 ANDA No. 040422
ADDERALL
2/11/2002
30 mg/5 mL
DELSYM
1/12/2009
5/25/2012
ANDA No. Exclusivity Granted 091135
20 mg/10 mg 2 mg, 5 mg and 10 mg 2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mL 5 mg/mL, 4mL pre-filled syringe
NUEDEXTA
3/7/2011 Prior to 12/8/2003
Tablets
VALIUM
Diazepam
Rectal Gel
DIASTAT
3/23/2004
Diazepam
Rectal Gel
DIASTAT ACUDIAL
12/8/2008
Drug
Dosage Form
Strength 5 mg/mL, 2mL pre-filled syringe 50 mg
RLD
ANDA Approval Date
Approval Letter
Diazepam
Rectal Gel
DIASTAT ACUDIAL
Diclofenac Potassium
Oral Solution (Sachet) Topical Gel Topical Solution Delayed-release Tablets Delayed-release Tablets Delayed-release Capsules
CAMBIA
1/24/2011
Diclofenac Sodium Diclofenac Sodium Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol
3% 2% 50 mg/0.2 mg 75 mg/0.2 mg 200 mg, 250 mg and 400 mg 60 mg, 90 mg and 120 mg 120 mg, 180 mg and 240 mg 120 mg, 180 mg, 240 mg and 300 mg
SOLARAZE PENNSAID ARTHROTEC ARTHROTEC
12/16/2009 7/11/2012 6/29/2009 11/28/2008 Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Expiration 6/16/2005) ANDA No. 077167
Didanosine
VIDEX EC
6/1/2004
12/3/2004
Diltiazem Hydrochloride
CARDIZEM SR
Prior to 12/8/2003 Prior to 12/8/2003 Exclusivity Granted (Pre-MMA) (Expiration ANDA No. 12/20/1999) 074752 Exclusivity Granted (Pre-MMA) (Sole exclusivity on ANDA No. 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg) 075401
DILACOR XR
CARDIZEM CD
Prior to 12/8/2003
7/9/1998
4/10/2003 TIAZAC Prior to 12/8/2003
Drug Diltiazem Hydrochloride
Dosage Form Extended-release Capsules
120 mg, 180 mg, 240 mg, Strength 300 mg, 360 mg and 420 mg
RLD TIAZAC
Approval Letter
Exclusivity Granted (Pre-MMA) (Sole exclusivity the ANDA No. 420 mg) 076563 Exclusivity Granted
Extended-release Tablets Extended-release Tablets Delayed-release Tablets Extended-release Tablets Extended-release Tablets
120 mg, 180 mg, 240 mg, 300 mg and 360 mg 420 mg 125 mg, 250 mg and 500 mg 250 mg
CARDIZEM LA
8/30/2005
3/15/2010
ANDA No. 077686 ANDA No. Exclusivity Granted 077686 No Exclusivity Granted
CARDIZEM LA
4/25/2005 Prior to 12/8/2003 5/3/2004
3/15/2010
Divalproex Sodium
DEPAKOTE
Divalproex Sodium
DEPAKOTE ER
ANDA No. Exclusivity Forfeited (Application Withdrawn (FDC Act 077143 505(j)(5)(D)(i)(II)) Exclusivity Granted (Expiration 8/1/2009) 1/29/2009 ANDA No. 077567
Divalproex Sodium
500 mg
DEPAKOTE ER
2/8/2005
Docetaxel
Injection
40 mg/mL, 0.5 mL and 2 mL vials
TAXOTERE
6/30/2009 Exclusivity Granted (Pre-MMA) (Expiration 5/28/2011) (Originally Shared Exclusivity; later FDA determination ANDA No. that no shared exclusivity for non-mutually blocking 076786 Paragraph IV Certifications) FDA Letter Decision
Donepezil Hydrochloride Tablets
5 mg and 10 mg
ARICEPT
Prior to 12/8/2003
11/26/2010
Orally Disintegrating 5 mg and 10 Donepezil Hydrochloride Tablets mg 250 mg/vial and 500 mg/vial
ARICEPT ODT
6/30/2010
11/25/2010
Exclusivity Granted, Then Revoked - Failure to ANDA No. Obtain Tentative Approval in 30 Months (FDC Act 078388 505(j)(5)(D)(i)(IV))
Doripenem
Injection
DORIBAX
10/12/2011
Drug Dorzolamide Hydrochloride Dorzolamide Hydrochloride and Timolol Maleate
Dosage Form
Strength
RLD TRUSOPT
ANDA Approval Date
Approval Letter
Exclusivity Decision No Exclusivity Granted
Ophthalmic Solution 2%
Ophthalmic Solution 2%/0.5%
COSOPT
10/11/2005
10/28/2008
Exclusivity Forfeited - Failure to Market (FDC Act ANDA No. 505(j)(5)(D)(i)(I)) 077847 FDA Letter Decision No Exclusivity Granted (Pre-MMA)
Doxazosin Mesylate
Tablets
1 mg, 2 mg, 4 mg, and 8 mg
CARDURA
Prior to 12/8/2003
Tentative Approval(s) Granted Doxepin Hydrochloride Tablets 3 mg and 6 mg SILENOR 9/16/2010 Tentative Approval(s) Granted Doxercalciferol Doxercalciferol Capsules Capsules 1 mcg 0.5 mcg and 2.5 mcg HECTOROL HECTOROL 2/12/2010 3/25/2009 9/23/2011 ANDA No. Exclusivity Granted (0.5 mcg) ; Tentative Approval(s) 091433 Granted (2.5 mcg) Tentative Approval(s) Granted; Failure to Obtain Tentative Approval in 30 Months Exception Applied ANDA No. FDC Act 505(j)(5)(D)(i)(IV)) 090040 FDA Citizen Petition Decision
Doxercalciferol
Injection
2 mcg/mL, 2 mL ampules
HECTOROL
10/15/2007
Doxercalciferol
Injection
2 mcg/mL, 1 mL in 2 mL vial
HECTOROL
12/28/2011 Exclusivity Granted (QI Act)
Doxycycline
Delayed-release Capsules
40 mg
ORACEA
12/11/2008
7/1/2010
ANDA No. 090855 Exclusivity Granted (QI Act; Shared) (Expiration ANDA No. 6/28/2011) (Failure to Obtain Tentative Approval in 30 090431 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV) & Citizen Petition exception) Exclusivity Granted (QI Act; Shared) (Expiration ANDA No. 6/28/2011) (Failure to Obtain Tentative Approval in 30 090505 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV) & Citizen Petition exception)
12/28/2010 Doxycycline Hyclate Delayed-release Tablets 75 mg and 100 mg DORYX PIV received prior to 2/5/2009 12/28/2010
Drug
Dosage Form Delayed-release Tablets
Strength
RLD
ANDA Approval Date
Approval Letter
Exclusivity Decision Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) See ANDA No. 091052
Doxycycline Hyclate
150 mg
DORYX
Drospirenone and Estradiol
Tablets
0.5 mg/1 mg
ANGELIQ
12/26/2007 Exclusivity Granted
Drospirenone and Ethinyl Tablets Estradiol
3 mg/0.02 mg
YAZ
9/29/2006
3/30/2009
ANDA No. 078515 Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act ANDA No. 505(j)(5)(D)(i)(IV)); FDA later determined that 180-day 077527 exclusivity was forfeited (FDC Act 505(j)(5)(D)(i)(IV)) and approved ANDA No. 090081.
Drospirenone and Ethinyl Tablets Estradiol
3 mg/0.03 mg
YASMIN
1/7/2005
5/9/2008
Drospirenone and Ethinyl Estradiol and Tablets Levomefolate
3 mg/0.02 mg/0.451 mg and 0.451 mg
BEYAZ
11/21/2011
Delayed-release Duloxetine Hydrochloride Capsules Delayed-release Capsules
20 mg, 30 mg and 60 mg
Tentative Approval(s) Granted CYMBALTA 8/4/2008
Duloxetine Hydrochloride
40 mg
CYMBALTA
5/10/2012 Exclusivity Granted/Forfeited (180-Day Punt) - Failure ANDA No. to Obtain Tentative Approval in 30 Months (FDC Act 090095 505(j)(5)(D)(i)(IV))
Dutasteride Dutasteride and Tamsulosin Hydrochloride
Capsules
0.5 mg
AVODART
10/29/2007
12/21/2010
Capsule
0.5 mg/0.4 mg
JALYN
10/26/2010
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter

Drug Efavirenz Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Dosage Form Tablets Strength 600 mg RLD SUSTIVA Date of Submission 4/9/2009 ANDA Approval Date Approval Letter
Tablets
600 mg/200 mg/300 mg
ATRIPLA
12/29/2008
Eletriptan Hydrobromide Emtricitabine and Tenofovir Disoproxil Fumarate Enalapril Maleate
Tablets
20 mg and 40 mg 200 mg/300 mg 2.5 mg, 5 mg, 10 mg and 20 mg 100 mg/mL, 0.3 mL, 0.4 mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes 150 mg/mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes 100 mg/mL, 3 mL vials 200 mg
RELPAX
3/29/2010
Tablets
TRUVADA
9/26/2008
Tablets
VASOTEC
Prior to 12/8/2003
Enoxaparin Sodium
Injection
LOVENOX
Prior to 12/8/2003
Enoxaparin Sodium
Injection
LOVENOX
Prior to 12/8/2003
Enoxaparin Sodium
Injection
LOVENOX
12/7/2006
Entacapone
Tablets
COMTAN
4/11/2007
Drug Entecavir
Dosage Form Tablets
Strength 0.5 mg and 1 mg
RLD BARACLUDE
ANDA Approval Date
Approval Letter
Epinastine Hydrochloride Ophthalmic Solution 0.05% 0.15 mg/0.3 mL and 0.3 mg/0.3 mL
ELESTAT
10/14/2008
3/14/2011
ANDA No. 090870
Epinephrine
Injection (Autoinjector)
EPIPEN AND EPIPEN JR.
7/20/2009
7/30/2008 Eplerenone Tablets 25 mg and 50 mg INSPRA 9/27/2006 8/1/2008
Eprosartan Mesylate
Tablets
400 mg and 600 mg 0.75 mg/mL, 100 mL vial 2 mg/mL, 10 mL vial 2 mg/mL, 100 mL vial 25 mg, 100 mg and 150 mg
TEVETEN
5/10/2010
11/16/2011
Eptifibatide Eptifibatide
Injection Injection
INTEGRILIN INTEGRILIN
6/5/2009 9/30/2008
Eptifibatide
Injection
INTEGRILIN
12/18/2008
Erlotinib Hydrochloride
Tablets
TARCEVA
11/18/2008
Escitalopram Oxalate
Capsules
5 mg
LEXAPRO
8/17/2005
7/31/2007
Capsules
10 mg and 20 mg 5 mg, 10 mg and 20 mg
LEXAPRO
3/30/2005 Prior to 12/8/2003
7/31/2007
Tablets
LEXAPRO
3/14/2012
Drug
Dosage Form
Strength 10 mg/mL, 10 mL vial 20 mg and 40 mg 20 mg/vial and 40 mg/vial
RLD
Date of Submission Prior to 12/8/2003 8/5/2005
Esmolol Hydrochloride Esomeprazole Magnesium
Injection Delayed-release Capsules
BREVIBLOC
NEXIUM
Esomeprazole Sodium
For Injection
NEXIUM IV
11/23/2009
Estradiol
Transdermal System
0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day 0.0375 mg/day and 0.06 mg/day 0.05 mg/day and 0.1 mg/day 1 mg; 1 mg and 0.09 mg 3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg 1 mg, 2 mg and 3 mg
VIVELLE DOT
4/27/2010
Estradiol
Transdermal System Transdermal System Tablets
CLIMARA
9/12/2005
7/20/2006
Estradiol Estradiol; Estradiol and Norgestimate Estradiol Valerate and Dienogest
CLIMARA
Prior to 12/8/2003 Prior to 12/8/2003 10/22/2010
2/24/2000
PREFEST
4/29/2005
Tablets
NATAZIA
Eszopiclone
Tablets
LUNESTA
12/15/2008
5/21/2011
ANDA No. 091169
7/31/2000 Etodolac Extended-release Tablets 400 mg, 500 mg and 600 mg LODINE XL Prior to 12/8/2003
ANDA No. 075665
Drug Etodolac
Dosage Form Extended-release Tablets
400 mg, 500 Strength mg and 600 mg
RLD LODINE XL
Ezetimibe
Tablets
10 mg 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg
ZETIA
10/25/2006
Ezetimibe and Simvastatin
Tablets
VYTORIN
7/27/2009
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Decision Tentative Approval(s) Granted Tentative Approval(s) Granted
Exclusivity Expired (Court Decision; Pre-MMA) See ANDA No. 077857
Exclusivity Expired (Court Decision; Pre-MMA) See ANDA No. 077857
Exclusivity Granted (Suitability Petition - Docket No. 2004P-0247) Exclusivity Granted (Suitability Petition - Docket No. 2004P-0247) Exclusivity Granted (Pre-MMA) (Expiration 9/10/2012)
Exclusivity Presumably Granted (Pre-MMA)
Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Sole Exclusivity on 500 mg & 600 mg; Expiration 2/13/2001)
Exclusivity Decision Exclusivity Granted (Pre-MMA) (Sole Exclusivity on 400 mg strength; Expiration 2/4/2001)

Drug Dosage Form Strength 125 mg, 250 mg and 500 mg 10 mg/mL, 2 mL vials; unpreserved 10 mg/mL, 4 mL and 20 mL vials; preserved 10 mg/mL, 50 mL vial, pharmacy bulk package; unpreserved RLD Date of Submission 12/28/2004 ANDA Approval Date 8/24/2007 Approval Letter ANDA No. 077487
Famciclovir
Tablets
FAMVIR
Famotidine
Injection
PEPCID
Prior to 12/8/2003
Famotidine
Injection
PEPCID
Prior to 12/8/2003
Famotidine
Injection
PEPCID
Prior to 12/8/2003
5/31/2001 Famotidine Tablets 10 mg (OTC) PEPCID AC Prior to 12/8/2003 11/28/2001 20 mg and 40 mg Prior to 12/8/2003 Prior to 12/8/2003 8/22/2003
ANDA No. 075312
ANDA No. 075404
Famotidine
Tablets
PEPCID PEPCID AC (CHEWABLE)
Famotidine
Tablets (Chewable) 10 mg (OTC)
ANDA No. 075715
Drug
Strength 2.5 mg, 5 mg and 10 mg 40 mg and 120 mg 43 mg and 130 mg
RLD
Felodipine
PLENDIL ER
Fenofibrate
Tablets
FENOGLIDE
3/17/2010
Fenofibrate
Capsules
ANTARA
9/15/2008
3/1/2012
ANDA No. 090859
Fenofibrate Choline Fenofibrate Choline
Delayed-release Capsules Delayed-release Capsules
45 mg 135 mg
TRILIPIX TRILIPIX
9/2/2009 9/1/2009
Fenofibrate
Capsules
67 mg, 134 mg and 200 mg
TRICOR
Prior to 12/8/2003
4/9/2002
ANDA No. 075753
Fenofibrate
Tablets
48 mg
TRICOR
7/1/2008 ANDA No. 076433 ANDA No. 076635
5/13/2005
Fenofibrate
Tablets
54 mg, 107 mg and 160 mg
TRICOR
Prior to 12/8/2003
10/31/2005
12/29/2005
ANDA No. 076520
Fenofibrate
Tablets
145 mg
TRICOR
10/19/2007
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date 11/21/2003 (6/22/2004 Converted to a Tentative Approval) (1/28/2005 Converted Back to a Final Approval)
Approval Letter
Fentanyl
Transdermal Extended-release Film
0.6 mg/24 hr, 1.2 mg/ 24 hr, 1.8 mg/ 24 hr and 2.4 mg/ 24 hr
DURAGESIC
Prior to 12/8/2003
ANDA No. 076258
Fentanyl Citrate
Buccal Tablets
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg
FENTORA
11/13/2007
1/7/2011
ANDA No. 079075
Fentanyl Citrate
Lozenges
0.2 mg
ACTIQ
10/29/2004
Fentanyl Citrate
Lozenges
0.4 mg
ACTIQ
10/6/2004
Fentanyl Citrate
Lozenges
0.6 mg
ACTIQ
12/20/2004
Fentanyl Citrate Fexofenadine Hydrochloride Fexofenadine Hydrochloride
Lozenges
0.8 mg, 1.2 mg and 1.6 mg 30 mg/5 mL 60 mg
ACTIQ
11/22/2004 ANDA No. 201311 ANDA No. 076169 ANDA No. 076191 ANDA No. 077081
Oral Suspension Capsules
ALLEGRA ALLEGRA
1/25/2010 Prior to 12/8/2003
7/25/2012 7/13/2005
8/31/2005 Fexofenadine Hydrochloride Tablets 30 mg, 60 mg and 180 mg ALLEGRA Prior to 12/8/2003 4/16/2007
Drug
Dosage Form
Strength
RLD
Date of Submission
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
60 mg/120 mg
ALLEGRA-D
Prior to 12/8/2003 11/12/2010 ANDA No. 076298
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Finasteride
180 mg/240 mg
ALLEGRA-D 24 HOUR
6/6/2007
3/16/2010
ANDA No. 079043
Tablets
1 mg
PROPECIA
Prior to 12/8/2003
7/28/2006
ANDA No. 076436
Finasteride
Tablets
5 mg
PROSCAR
Prior to 12/8/2003 Prior to 12/8/2003 Prior to 12/8/2003
6/19/2006
ANDA No. 076340 ANDA No. 075442
Flecainide Acetate
Tablets
50 mg, 100 mg and 150 mg
TAMBOCOR
7/31/2001
Fluconazole
50 mg/5 mL For Oral Suspension and 200 mg/5 mL 50 mg, 100 mg, 150 mg and 200 mg 0.025%
DIFLUCAN FOR ORAL SUSPENSION
Fluconazole
Tablets
DIFLUCAN
Prior to 12/8/2003 Prior to 12/8/2003 1/31/2008 Prior to 12/8/2003
Flunisolide
Nasal Solution
NASALIDE
Fluocinonide
Cream
0.10%
VANOS
Fluocinonide
Ointment
0.05%
LIDEX
Drug Fluorouracil
Dosage Form Cream
Strength 0.50%
RLD CARAC
ANDA Approval Date
Approval Letter
Fluoxetine Hydrochloride Tablets
10 mg and 20 mg
PROZAC
Prior to 12/8/2003
8/2/2001
ANDA No. 075755
8/2/2001
ANDA No. 075049
Fluoxetine Hydrochloride Capsules
PROZAC
Prior to 12/8/2003
8/2/2001
ANDA No. 074803
8/2/2001
ANDA No. 075465
Fluoxetine Hydrochloride
90 mg
PROZAC WEEKLY
Prior to 12/8/2003
3/24/2010
ANDA No. 076237
Fluoxetine Hydrochloride Oral Solution
20 mg (base)/5 mL
PROZAC
Prior to 12/8/2003
8/2/2001
ANDA No. 075506
Fluoxetine Hydrochloride Capsules
10 mg and 20 mg
SARAFEM
Prior to 12/8/2003 Prior to 12/8/2003
5/20/2008
ANDA No. 076287
Flutamide
Capsules
125 mg
EULEXIN
Fluticasone Furoate
Nasal Spray
27.5 mcg
Veramyst
7/15/2011 ANDA No. 090759
Fluticasone Propionate
Lotion
0.05%
CUTIVATE
7/28/2008
5/2/2011
Drug Fluvastatin Fluvastatin Sodium
Dosage Form Capsules Extended-release Tablets Injection Extended-release Capsules Extended-release Capsules Inhalation Solution Tablets Injection Injection
Strength 20 mg and 40 mg 80 mg 50 mg/mL, 2.5 mL and 5 mL syringe 100 mg 150 mg 0.02 mg/2 mL 700 mg 115 mg/vial 150 mg/vial 10 mg, 20 mg and 40 mg 10 mg/12.5 mg and 20 mg/12.5 mg
RLD LESCOL LESCOL XL
Date of Submission 6/4/2008 3/15/2007
ANDA Approval Date
Approval Letter
Fulvestrant
FASLODEX
10/1/2009
Fluvoxamine Maleate Fluvoxamine Maleate Formoterol Fumarate Fosamprenavir calcium Fosaprepitant dimeglumine Fosaprepitant dimeglumine Fosinopril Sodium
LUVOX CR LUVOX CR PERFOROMIST LEXIVA EMEND EMEND
4/20/2009 4/13/2009 1/21/2009 1/18/2012 1/25/2012 1/25/2012 Prior to 12/8/2003 Prior to 12/8/2003 ANDA No. 076139 ANDA No. 076608
Tablets
MONOPRIL
11/25/2003
Fosinopril Sodium and Hydrochlorothiazide
Tablets
MONOPRIL HCT
12/3/2004
Frovatriptan Succinate
Tablets
2.5 mg
FROVA
3/9/2011
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Granted (Pre-MMA) (Second period granted)
No Exclusivity Granted (Pre-MMA) Exclusivity Granted (Pre-MMA)
Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) FDA Citizen Petition Decision
Exclusivity Granted (Pre-MMA) (Expiration 9/15/2002; 134 mg & 200 mg) (Exclusivity on 67 mg likely expired before commercial marketing)
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Pre-MMA; Shared) (Expiration 5/22/2006; 54 mg & 160 mg) Exclusivity Granted (Pre-MMA; Shared) (Expiration 5/22/2006; 54 mg & 160 mg)
Exclusivity Granted (Pre-MMA) (107 mg)
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
Exclusivity Decision Exclusivity Expired (Pre-MMA)
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
No Exclusivity Granted (Likely Forfeiture)
Exclusivity Granted Exclusivity Granted (Pre-MMA) Exclusivity Granted (Pre-MMA) (30 mg, 60 mg, and 180 mg) Selectively Waived - See ANDA No. 76-447 Exclusivity Granted (Pre-MMA) (Expiration 10/21/2008; 30 mg & 60 mg) (Second Period)
Exclusivity Granted (Pre-MMA) (Second Period)
Exclusivity Granted (Pre-MMA) (Expiration 10/28/2002) No Exclusivity Granted (Pre-MMA)
Tentative Approval(s) Granted No Exclusivity Granted (Pre-MMA)
Exclusivity Granted (Pre-MMA) (Expiration 1/29/2002; 10 mg strength)
Exclusivity Granted (Pre-MMA) (Expiration 1/29/2002; 20 mg strength)
Exclusivity Granted (Pre-MMA) (Expiration 1/29/2002; 40 mg strength) Exclusivity Expired (Pre-MMA) (Expiration 3/20/2010) Court Decision Trigger - See ANDA No. 078572 Exclusivity Granted (Pre-MMA) (Expiration 1/29/2002)
Exclusivity Granted

Drug Gabapentin Dosage Form Capsules Strength 100 mg, 300 mg and 400 mg 250 mg/5 mL RLD NEURONTIN Date of Submission Prior to 12/8/2003 Prior to 12/8/2003 ANDA Approval Date 9/12/2003 Approval Letter ANDA No. 075350 ANDA No. 078974
Gabapentin
Oral Solution
NEURONTIN
2/18/2011
Gabapentin
Tablets
300 mg and 600 mg 100 mg, 300 mg and 400 mg 600 mg and 800 mg 8 mg
GRALISE
10/31/2011
Gabapentin
Tablets
NEURONTIN
Prior to 12/8/2003 Prior to 12/8/2003 3/2/2006
4/28/2004
Gabapentin Galantamine Hydrobromide
Tablets Extended-release Capsules
NEURONTIN
10/21/2004
RAZADYNE ER
9/15/2008
Galantamine Hydrobromide
16 mg and 24 mg
RAZADYNE ER
3/11/2006
9/15/2008
9/11/2008
8/28/2008
Galantamine Hydrobromide
Tablets
RAZADYNE
2/28/2005
8/28/2008
ANDA No. 077605
Galantamine Hydrobromide Drug
Tablets Dosage Form
4 mg, 8 mg and 12 mg Strength
RAZADYNE RLD
2/28/2005 Date of Submission
2/11/2009
ANDA No. 077608 ANDA No. 076457
Ganciclovir Sodium
Capsules
250 mg and 500 mg 250 mcg/0.5 mL, 1 mL 10 mg/mL, 20 mL and 40 mL vials
CYTOVENE
Prior to 12/8/2003 3/30/2012
6/27/2003
Ganirelix Acetate
Injection
PFS Ganirelix Acetate
Gatifloxacin
Injection
TEQUIN
11/24/2004 ANDA No. 079084
Gatifloxacin Gatifloxacin
Ophthalmic Solution 0.30% Ophthalmic Solution 0.50%
ZYMAR ZYMAXID
7/19/2007 12/7/2010
8/19/2011
Gatifloxacin
Tablets
200 mg and 400 mg 2 mg/mL, 100 mL and 200 mL containers (plastic)
TEQUIN
Likely Prior to 12/8/2003
Gatifloxacin in Dextrose 5% in Plastic Container
Injection
TEQUIN
12/13/2004
Gemcitabine
For Injection
200 mg/vial
GEMZAR
11/1/2005
1/25/2011
ANDA No. 077983
Gemcitabine
For Injection
1g/vial
GEMZAR
11/14/2005
1/25/2011(Initial approval on 12/18/2008, but converted to tentative approval)
ANDA No. 077983
Drug Gemcitabine
Dosage Form For Injection
Strength 2 g/vial
RLD GEMZAR
Gemifloxacin Mesylate
Tablets
320 mg 20 mg/mL, 1mL pre-filled syringe 1 mg/4 mg, 2 mg/4 mg and 4 mg/4 mg 8 mg/2 mg and 8 mg/4 mg
FACTIVE
3/4/2008
Glatiramer Acetate
Injection
COPAXONE
12/27/2007
Glimepiride and Rosiglitazone Maleate Glimepiride and Rosiglitazone Maleate
Tablets
AVANDARYL
12/22/2006
Tablets
AVANDARYL
5/30/2008 ANDA No. 076467 (10 mg) ANDA No. 076467 ANDA No. 074591
9/8/2003 Glipizide Extended-release Tablets 2.5 mg, 5 mg and 10 mg GLUCOTROL XL Prior to 12/8/2003 9/8/2003 1.5 mg, 3 mg, 4.5 mg and 6 mg 1.25mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg
Glyburide
Tablets
GLYNASE
Prior to 12/8/2003
12/22/1997
Glyburide/Metformin Hydrochloride
Tablets
GLUCOVANCE
Prior to 12/8/2003
2/18/2004
ANDA No. 076345
Glycopyrrolate
Tablets
1 mg
ROBINUL
8/14/2009
Glycopyrrolate
Tablets
1.5 mg
ROBINUL FORTE
5/6/2009
Drug Glycopyrrolate Glycopyrrolate
Dosage Form Tablets Oral Solution
Strength 2 mg 1 mg/5 mL 0.1 mg/mL, 1 mL single dose vial
RLD ROBINUL FORTE CUVPOSA
ANDA Approval Date
Approval Letter
Granisetron Hydrochloride
Injection
KYTRIL
3/8/2007
Injection
1 mg/mL, 1 mL vials
12/31/2007 KYTRIL 6/1/2004 1/3/2008
Injection
1 mg/mL, 4 mL multi-dose vials 600 mg and 1.2 gm 600 mg/30 mg and 1200 mg/60 mg 600 mg/60 mg and 1200 mg/120 mg 1 mg, 2 mg, 3 mg and 4 mg
KYTRIL
7/19/2004
12/31/2007
Guaifenesin
Extended-release Tablets Extended-release Tablets Extended-release Tablets
MUCINEX
6/9/2006
Guaifenesin and Dextromethorphan Guaifenesin and Pseudoephedrine Hydrochloride Guanfacine Hydrochloride
MUCINEX DM
12/17/2008
MUCINEX-D
12/29/2008
INTUNIV
12/29/2009
10/5/2012
ANDA No. 200881
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Granted (Pre-MMA) (Expiration 6/11/2005) Exclusivity Granted (Expiration 12/14/2008)
Exclusivity Decision Exclusivity Granted (Shared) (Expiration 2/24/2009)
Exclusivity Granted
Exclusivity Decision Exclusivity Granted (Expiration 5/14/2011) (Suitability Petition - Docket No. 2006P-0145) Tentative Approval(s) Granted
Exclusivity Presumably Selectively Waived, Relinquished, or Triggered by Authorized Generic Marketing (Pre-MMA) (2.5 mg & 10 mg) Exclusivity Granted (Pre-MMA) (Expiration 10/19/2003; 5 mg strength) Exclusivity Granted (Pre-MMA) (Expiration 6/1/1998)
(Suitability Petition ANDA - Docket No. 2006P-0300)
No Exclusivity Granted (Presumably Forefeited)
Exclusivity Granted (Expiration 6/28/2008; Presumably shared) FDA Letter Decision Exclusivity Granted (Expiration 6/28/2008; Presumably shared) Exclusivity Granted (Expiration 6/28/2008)
Exclusivity Presumably Granted

Drug Hydrochlorthiazide and Triamterene Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen Dosage Form Tablets Strength 50 mg and 75 mg 2.5 mg/200 mg RLD MAXZIDE Date of Submission Prior to 12/8/2003 2/24/2006 ANDA Approval Date 12/8/1987 Approval Letter ANDA No. 071360 ANDA No. 076642
Tablets
VICOPROFEN
10/19/2007
Tablets
5 mg/200 mg
VICOPROFEN
5/27/2005
Tablets
5 mg/200 mg
VICOPROFEN
Prior to 12/8/2003
3/18/2004
ANDA No. 076642 ANDA No. 076023 ANDA No. 076604 ANDA No. 077723
Hydrocodone Bitartrate and Ibuprofen
Tablets
7.5 mg/200 mg
VICOPROFEN
Prior to 12/8/2003
4/11/2003 12/31/2003
Hydrocodone Bitartrate and Ibuprofen
Tablets
10 mg/200 mg
VICOPROFEN
Likely On or After 12/8/2003 6/28/2010 9/2/2010 8/2/2010 2/25/2011 11/4/2011
11/6/2006
Hydrocortisone Butyrate Hydromorphone Hydrochloride Hydromorphone Hydrochloride Hydromorphone hydrochloride Hydromorphone hydrochloride
Cream Extended-release Tablets Extended-release Tablets Oral Solution Injection
0.10% 8 mg and 12 mg 16 mg 5 mg/5mL 10 mg/mL
LOCOID LIPOCREAM EXALGO EXALGO DILAUDID DILAUDID-HP
Drug Hydromorphone Hydrochloride
Dosage Form Injection
Strength 2 mg/mL
RLD DILAUDID
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Decision Exclusivity Granted (Pre-MMA) (Expiration 4/17/1988) Exclusivity Granted (Suitability Petition - Docket No. 2005P-0180)
(Suitability Petition - Docket No. 2002P-0270) Exclusivity Granted (Pre-MMA) (Expiration 12/5/2004) (Suitability Petition - Docket No. 2002P-0270)
Exclusivity Granted (Pre-MMA) Exclusivity Granted (Pre-MMA) (Expiration10/11/2004) (second period) Exclusivity Granted (Suitability Petition - Docket No. 2001P-0442)

Drug Ibandronate Sodium Dosage Form Injection Strength 1 mg/mL, 3 mL Vial RLD BONIVA Date of Submission 8/31/2007 3/19/2012 2.5 mg and 150 mg ANDA No. 078948 ANDA No. 078995 ANDA No. 078998 ANDA Approval Date Approval Letter
Ibandronate Sodium
Tablets
BONIVA
5/16/2007
3/19/2012
3/19/2012 CHILDREN'S MOTRIN DROPS CONCENTRATED MOTRIN INFANT DROPS (RX) MOTRIN (OTC) CHILDREN'S MOTRIN CHILDREN'S MOTRIN, JUNIOR STRENGTH MOTRIN Prior to 12/8/2003 6/29/2007 Prior to 12/8/2003 Prior to 12/8/2003 Prior to 12/8/2003
Ibuprofen
Oral Drops
40 mg/mL
Ibuprofen
Oral Suspension
50 mg/1.25 mL
Ibuprofen
Oral Suspension
100 mg/5 mL
Ibuprofen
Oral Suspension
100 mg/5 mL
Ibuprofen
Chewable Tablets
50 mg and 100 mg
1/16/2004
ANDA No. 076359
Ibuprofen Lysine
Injection
10 mg/mL, 2 mL vial
NEOPROFEN
10/1/2010
Ibuprofen and Famotidine Tablets
800 mg/26.6 mg
DUEXIS
12/6/2011
Drug Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride
Dosage Form Oral Suspension
Strength 100 mg/ 15 mg per 5 mL
RLD CHILDREN'S MOTRIN COLD ADVIL COLD AND SINUS
Date of Submission Prior to 12/8/2003 Prior to 12/8/2003
Approval Letter ANDA No. 076478 ANDA No. 074567
Tablets
200 mg/30 mg
4/17/2001
Ibuprofen Potassium and Pseudoephedrine Capsules Hydrochloride Ifosfamide For Injection
200 mg/30 mg
ADVIL COLD AND SINUS
12/27/2004
1 g/vial and 3 g/vial 50 mg/mL, 20 mL vials and 60 mL vials 1 g/vial; 100 mg/mL, 10 mL vials and 3 g/vial; 100 mg/mL, 10 mL vials 50 mg/mL, 20 mL and 60 mL vials; 100 mg/mL, 10 mL vial 100 mg and 400 mg
IFEX
Prior to 12/8/2003
5/28/2002
ANDA No. 076078
Ifosfamide
Injection
IFEX
Prior to 12/8/2003
Ifosfamide/ Mesna
For Injection/ Injection Kit
IFEX/MESNEX KIT
Prior to 12/8/2003
2/26/2002
ANDA No. 075874
Ifosfamide/ Mesna
Injection/ Injection Kit
IFEX/ MESNEX KIT
Prior to 12/8/2003
Imatinib Mesylate
Tablets
GLEEVEC
3/12/2007
Imiquimod
Cream
5%
ALDARA
10/17/2006
2/25/2010
ANDA No. 078548
Indomethacin
75 mg
INDOCIN SR
Prior to 12/8/2003
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Irbesartan
Tablets
75 mg, 150 mg and 300 mg
AVAPRO
5/25/2004
3/30/2012
Irbesartan and Hydrochlorothiazide
Tablets
150 mg/12.5 mg and 300 mg/12.5 mg
AVALIDE
11/10/2004
3/30/2012
ANDA No. 077369
Irbesartan and Hydrochlorothiazide
Tablets
300 mg/25 mg
AVALIDE
6/6/2006
3/30/2012
ANDA No. 077369
Irinotecan Hydrochloride
Injection
20 mg/mL, 2 mL and 5 mL vials
CAMPTOSAR
7/26/2004
2/20/2008
ANDA No. 077219
Itraconazole
Capsules
100 mg
SPORANOX
Prior to 12/8/2003
5/28/2004
ANDA No. 076104
Ixabepilon
Injection
15 mg/vial and 45 mg/vial, single-use vials
IXEMPRA KIT
4/16/2012
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) (150 mg) Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) (150 mg)
No Exclusivity Granted (Pre-MMA; Rx-to-OTC Switch) Exclusivity Relinquished (Pre-MMA) See ANDA No. 074937 Exclusivity Granted (Pre-MMA)
Exclusivity Granted (Expiration 8/24/2010) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV))
Exclusivity Decision Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) (Expiration 9/26/2012) FDA Petition Decision Exclusivity Granted (Expiration 9/26/2012)
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months - FDC Act 505(j)(5)(D)(i)(IV))

Drug Dosage Form Strength RLD Date of Submission ANDA Approval Date Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker

Drug Ketoconazole Dosage Form Foam Strength 2% 25 mg, 50 mg and 75 mg 15 mg/mL and 30 mg/mL RLD EXTINA Date of Submission 7/30/2009 Prior to 12/8/2003 Prior to 12/8/2003 ANDA Approval Date 8/25/2011 Approval Letter ANDA No. 091550
Ketoprofen
Capsules
ORUDIS
Ketorolac Tromethamine Injection
TORADOL
Ketorolac Tromethamine Opthalmic Solution
0.45%
ACUVAIL
8/24/2011 Prior to 12/8/2003 1/28/2005 Prior to 12/8/2003 3/12/2012 12/23/2004 5/9/2006 ANDA No. 077354
Ketorolac Tromethamine Ophthalmic Solution 0.50%
ACULAR
Ketorolac Tromethamine Ophthalmic Solution 0.40%
ACULAR LS
Ketorolac Tromethamine Tablets Ketorolac Tromethamine Nasal Spray Ketotifen Fumarate
10 mg 15.75 mg/spray
TORADOL SPRIX ZADITOR
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
No Exclusivity Granted (Pre-MMA) No Exclusivity Granted (Forfeiture)

Drug Lactulose Lactulose Lamivudine Lamivudine Lamivudine and Zidovudine Lamivudine Dosage Form Oral Syrup Oral Syrup Tablets Tablets Tablets Oral Solution Strength 10 g/15 mL 10 g/15 mL 100 mg 150 mg and 300 mg 150 mg/300 mg 10 mg/mL 25 mg, 100 mg, 150 mg and 200 mg 2 mg, 5 mg and 25 mg RLD CEPHULAC CHRONULAC EPIVIR-HBV EPIVIR COMBIVIR EPIVIR Date of Submission Prior to 12/8/2003 Prior to 12/8/2003 10/31/2007 10/16/2007 6/26/2007 11/22/2011 Prior to 12/8/2003 ANDA No. 076388 5/25/2011 ANDA No. 079081 ANDA Approval Date Approval Letter
Lamotrigine
Tablets
LAMICTAL
8/30/2006
Lamotrigine
Chewable Tablets
LAMICTAL CD
Prior to 12/8/2003
6/21/2006
ANDA No. 076420
Lamotrigine
25 mg, 50 mg, Orally Disintegrating 100 mg, and Tablets 200 mg Delayed-release Pellets/Capsules 15 mg and 30 mg
LAMICTAL ODT
12/21/2009
Lansoprazole
PREVACID
12/5/2005
Lansoprazole
Delayed-release 15 mg and 30 Orally Disintegrating mg Tablets
PREVACID
12/27/2006
10/15/2010
ANDA No. 078730
Drug
Dosage Form
Strength 500 mg, 750 mg and 1000 mg 250 mg
RLD
ANDA Approval Date
Approval Letter
Lanthanum Carbonate
Chewable Tablet
FOSRENOL
Lapatinib Ditosylate
Tablets
TYKERB
3/14/2011 Prior to 12/8/2003 8/30/2010 7/12/2010 3/2/2006 Prior to 12/8/2003 6/20/2005 4/9/2008 ANDA No. 077756 ANDA No. 078309 12/24/2008 ANDA No. 078190
Latanoprost Lenalidomide Lenalidomide Letrozole Leuprolide Acetate Levalbuterol Hydrochloride Levalbuterol Hydrochloride Levalbuterol Tartrate
Ophthalmic Solution 0.005% Capsules Capsules Tablets Injection (depot) 5 mg, 10 mg and 15 mg 25 mg 2.5 mg 7.5 mg/vial 0.0103%, 0.021% and 0.042% 0.25% 0.045 mg/actuation 250 mg, 500 mg and 750 mg 1000 mg
XALATAN REVLIMID REVLIMID FEMARA LUPRON DEPOT
Inhalation Solution
XOPENEX
Inhalation Solution
XOPENEX
5/23/2006
3/20/2009
Inhalation Aerosol
XOPENEX
2/27/2012
Levetiracetam
Tablets
KEPPRA
Prior to 12/8/2003
Levetiracetam
Tablets
KEPPRA
1/24/2007
9/12/2011
ANDA No. 091093
Drug
Dosage Form
Strength
RLD
Date of Submission
Approval Letter ANDA No. 091261 ANDA No. 091285 ANDA No. 091291 ANDA No. 091430 ANDA No. 091399 ANDA No. 091557 ANDA No. 091360 ANDA No. 200475 ANDA No. 091263 ANDA No. 090229
9/12/2011
9/12/2011
Levetiracetam
500 mg and 750 mg
KEPPRA XR
1/7/2011
9/12/2011
9/12/2011
9/12/2011
10/4/2011
12/19/2011 Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride
Oral Solution
0.5 mg/mL
XYZAL
1/14/2009
11/7/2011
Tablets
5 mg 5 mg/mL; 50 mL, 100 mL and 150 mL vials 25 mg/mL
XYZAL LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVAQUIN
12/17/2007
11/26/2010
Levofloxacin
Injection
Prior to 12/8/2003 Prior to 12/8/2003
Levofloxacin
Injection
Drug Levofloxacin Levofloxacin
Dosage Form
Strength
RLD QUIXIN LEVAQUIN
Date of Submission Prior to 12/8/2003 7/30/2009
ANDA Approval Date
Approval Letter
Ophthalmic Solution 0.50% Oral Solution 25 mg/mL
Levofloxacin
Tablets
250 mg, 500 mg and 750 mg
LEVAQUIN
Prior to 12/8/2003
10/15/2004 (Converted to a Tentative Approval 2/1/2005) 1/26/2005 (Converted to a Tentative Approval 7/12/2006)
ANDA No. 076276
ANDA No. 076361
Levoleucovorin Calcium
Injection
10 mg/mL, 17.5 mL vial and 25 mL vial 0.09 mg/0.02 mg 0.15 mg/0.03 mg
FUSILEV
10/26/2011
Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol
Tablets Tablets
LYBREL SEASONALE
10/5/2007 3/29/2004 9/6/2006 ANDA No. 077101 ANDA No. 200407 ANDA No. 091674 ANDA No. 078834
Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol
Tablets
0.1 mg/0.02 mg and 0.01 mg
10/25/2011 LOSEASONIQUE 11/16/2009 10/26/2011
Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol
Tablets
0.15 mg/0.03 mg/0.01 mg
SEASONIQUE
1/22/2008
5/31/2011
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Levothyroxine Sodium
Tablets
0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.150 mg, 0.175 mg, 0.2 mg and 0.3 mg
LEVOXYL
Prior to 12/8/2003
Lidocaine
Topical Patch
5% 2 mg/mL, 100 mL bag 2 mg/mL, 300 mL bag 100 mg/5 mL 600 mg 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
LIDODERM
11/13/2009
8/23/2012
ANDA No. 200675
Linezolid
Injection
ZYVOX
12/29/2009 ANDA No. 200222
Linezolid
Injection
ZYVOX
9/1/2009
6/27/2012
Linezolid Linezolid
Oral Suspension Tablets
ZYVOX ZYVOX
8/3/2009 12/21/2005
Lisdexamfetamine Dimesylate
Capsules
VYVANSE
2/23/2011
Loperamide Hydrochloride and Simethicone Loperamide Hydrochloride and Simethicone
Chewable Tablets
2 mg/125 mg
IMODIUM ADVANCED
Prior to 12/8/2003
8/30/2002
ANDA No. 076029
Tablets
2 mg/125 mg (OTC)
IMODIUM ADVANCED
12/29/2004
9/6/2006
ANDA No. 077500
Drug
Dosage Form
Strength 100 mg/25 mg and 200 mg/50 mg
RLD
ANDA Approval Date
Approval Letter
Lopinavir and Ritonavir
Tablets
KALETRA
Loratadine
Syrup
1 mg/mL
CLARITIN
Prior to 12/8/2003
11/7/2003
ANDA No. 075505
Loratadine
Tablets
10 mg
CLARITIN
Prior to 12/8/2003
1/21/2003
ANDA No. 075209
Loratadine
Orally Disintegrating 10 mg Tablets
CLARITIN REDITABS
Prior to 12/8/2003
2/10/2003
ANDA No. 075822
Loratadine/ Pseudoephedrine
5 mg/120 mg
CLARITIN D-12 HOUR
Prior to 12/8/2003
1/30/2003
ANDA No. 076050
Loratadine/ Pseudoephedrine
10 mg/240 mg
CLARITIN D-24 HOUR
Prior to 12/8/2003
2/21/2003
ANDA No. 075706
Losartan Potassium
Tablets
25 mg, 50 mg, and 100 mg 50 mg/12.5 mg and 100 mg/25 mg 100 mg/12.5 mg 20 mg/500 mg 20 mg/750 mg
COZAAR
4/6/2010
ANDA N0. 076958
Losartan Potassium and Hydrochlorothiazide
Tablets
HYZAAR
5/24/2004
4/6/2010
ANDA No. 077157
Losartan Potassium and Hydrochlorothiazide Lovastatin and Niacin Lovastatin and Niacin
Tablets Extended-release Tablets Extended-release Tablets
HYZAAR
4/4/2006
ADVICOR ADVICOR
9/22/2008 12/17/2008
Drug Lovastatin and Niacin Lovastatin and Niacin Lubiprostone
Dosage Form Extended-release Tablets Extended-release Tablets Capsules
Strength 20 mg/1000 mg 40 mg/1000 mg 8 mcg and 24 mcg
RLD ADVICOR ADVICOR AMITIZA
Date of Submission 5/22/2008 11/19/2009 8/20/2012
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Tentative Approval(s) Granted Tentative Approval(s) Granted Exclusivity Granted (Expiration 5/15/2012)
Exclusivity Granted (Pre-MMA) (Expiration 2/25/2007; 5 mg) (Expiration 2/25/2006; 25 mg)
No Exclusivity Granted (Forfeiture; Presumably Patent Expiration)
No Exclusivity Granted (Pre-MMA) (patent exp)
Exclusivity Granted
Exclusivity Granted
No Exclusivity Granted (Pre-MMA) (patent exp)
Exclusivity Forfeited - Patent Expiration (FDC Act 505(j)(5)(D)(i)(VI)) Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Decision Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) Tentative Approval(s) Granted
Exclusivity Decision No Exclusivity Granted (Pre-MMA) (patent expiration) Tentative Approval(s) Granted Exclusivity Granted (Pre-MMA) (250 mg & 500 mg)
Exclusivity Granted Exclusivity Granted
Exclusivity Granted
Exclusivity Granted (Expiration 10/3/2010) FDA Letter Decision Exclusivity Granted (Expiration 10/3/2010) FDA Letter Decision No Exclusivity Granted

Drug Malathion Dosage Form Topical Lotion Strength 0.50% 150 mg and 300 mg RLD OVIDE Date of Submission 3/16/2011 ANDA Approval Date Approval Letter
Maraviroc
Tablets
SELZENTRY
8/8/2011
Mefloquine Hydrochloride Tablets
250 mg
LARIAM
Prior to 12/8/2003
2/20/2002
ANDA No. 076175
Megestrol Acetate
Oral Suspension
40 mg/mL
MEGACE
Prior to 12/8/2003
7/25/2001
ANDA No. 075671
Megestrol Acetate
Oral Suspension
125 mg/mL
MEGACE ES
4/27/2011
Meloxicam
Oral Suspension
7.5 mg/5 mL
MOBIC
12/17/2009 ANDA No. 090048
4/14/2010 Memantine Hydrochloride Tablets 5 mg and 10 mg NAMENDA 10/16/2007 5/5/2010 Delayed-release Tablets Delayed-release Tablets Delayed-release Tablets
ANDA No. 090058
Mesalamine Mesalamine Mesalamine
400 mg 800 mg 1.2 g
ASACOL ASACOL HD LIALDA
6/22/2007 7/13/2011 12/16/2009
Drug Mesalamine Metaxalone
Dosage Form Extended-release Capsules Tablets
Strength 0.375 g 400 mg
RLD APRISO SKELAXIN
Date of Submission 4/3/2012 Prior to 12/8/2003
ANDA Approval Date
Approval Letter
Metaxalone
Tablets
800 mg
SKELAXIN
11/4/2004
3/31/2010
6/16/2004
10/28/2003 Metformin Hydrochloride Extended-release Tablets 500 mg GLUCOPHAGE XR Prior to 12/8/2003 7/30/2004
ANDA No. 076249
10/1/2004
ANDA No. 076450
Metformin Hydrochloride
Extended-release Tablets Extended-release Tablets Extended-release Tablets Extended-release Capsules Extended-release Capsules Extended-release Capsules
750 mg 500 mg and 1000 mg 500 mg and 1000 mg 10 mg 10 mg, 20 mg and 30 mg 20 mg, 30 mg and 40 mg
GLUCOPHAGE XR
Prior to 12/8/2003 10/14/2008 7/27/2009 5/21/2007
10/14/2004
ANDA No. 76863 ANDA No. 090692
Metformin Hydrochloride Metformin Hydrochloride Methylphenidate Hydrochloride Methylphenidate Hydrochloride Methylphenidate Hydrochloride
FORTAMET GLUMETZA RITALIN LA
6/29/2011
METADATE CD
5/13/2005
7/19/2012
ANDA No. 77707 ANDA No. 078458
RITALIN LA
8/21/2006
12/1/2011
Drug Methylphenidate Hydrochloride Methylphenidate Hydrochloride Methylphenidate Hydrochloride
Dosage Form Extended-release Capsules Extended-release Tablets
Strength 40 mg 18 mg, 27 mg, 36 mg and 54 mg 5 mg/5 mL and10 mg/5 mL 10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs and 30 mg/9 hrs 5 mg/mL, 2 mL, 10 mL, 20 mL and 30 mL vials
RLD METADATE CD
Approval Letter ANDA No. 078873 ANDA No. 202608 ANDA No. 091601
CONCERTA
7/19/2005
12/28/2012
Oral Solution
METHYLIN
4/13/2010
7/23/2010
Methylphenidate
Transdermal System
DAYTRANA
4/13/2011
Metoclopramide Hydrochloride
Injection
REGLAN
Prior to 12/8/2003
Metoclopramide Hydrochloride
Orally Disintegrating 5 mg and 10 Tablets mg
METOZOLV ODT
8/24/2010
Prior to 12/8/2003 25 mg, 50 mg, 100 mg and 200 mg
5/18/2007
ANDA No. 076640
Metoprolol Succinate
TOPROL XL
7/31/2006
ANDA No. 076969
Prior to 12/8/2003
Metronidazole
Vaginal Gel
0.75%
METROGELVAGINAL METROGEL
9/2/2004
10/31/2006
ANDA No. 077264 ANDA No. 090903
Metronidazole
Topical Gel
1%
10/21/2008
7/22/2011
Drug Miconazole Nitrate
Dosage Form Vaginal Cream and Suppository
Strength 2% and 1.2 g
RLD MONISTAT 1 COMBINATION PACK
2/3/2009
3/17/2009 Minocycline Hydrochloride Extended-release Tablet 45 mg, 90 mg and 135 mg SOLODYN PIV received prior to 2/5/2009 8/13/2009
ANDA No. 065485
ANDA No. 090422
7/20/2010
ANDA No. 090911
Minocycline Hydrochloride Minocycline Hydrochloride Minocycline Hydrochloride Minoxidil
Extended-release Tablet Extended-release Tablet Extended-release Tablet Topical Aerosol Foam
55 mg and 80 mg 65 mg and 115 mg 105 mg
SOLODYN
12/2/2010
SOLODYN SOLODYN
11/19/2009 12/28/2010 ANDA No. 091344
5%
MENS ROGAINE
4/6/2009
4/28/2011
1/24/2003 Mirtazapine Tablets 7.5 mg, 15 mg, 30 mg, and 45 REMERON mg Prior to 12/8/2003 4/22/2004
ANDA No. 076119
ANDA No. 076541
Drug
Dosage Form
Strength
RLD
Date of Submission
Approval Letter ANDA No. 076307 ANDA No. 076689 ANDA No. 076901
Mirtazapine
Orally Disintegrating 15 mg, 30 mg Tablets and 45 mg
REMERON SOLTAB
Prior to 12/8/2003
8/31/2005
6/28/2005
Modafinil
Tablets
100 mg and 200 mg
PROVIGIL
Prior to 12/8/2003
ANDA No. 076596
Moexipril Hydrochloride
Tablets
7.5 mg and 15 mg 7.5mg/12.5mg 15 mg/25 mg and 15 mg/12.5 mg 50 mcg/ Spray
UNIVASC
Priot to 12/8/2003
5/8/2003
ANDA No. 076204
Moexipril Hydrochloride and Hydrochlorothiazide
Tablets
UNIRETIC
1/15/2004
Mometasone Furoate
Nasal Spray Topical Solution (Cream) Topical Solution (Lotion) Tablets Chewable Tablets Oral Granules
NASONEX
8/7/2009 Prior to 12/8/2003 6/10/2004 2/20/2007 12/26/2006 10/17/2008 8/3/2012 ANDA No. 090955 4/6/2005 ANDA No. 077180
Mometasone Furoate
0.10%
ELOCON
Mometasone Furoate Montelukast Montelukast Sodium Montelukast Sodium
0.10% 10 mg 4 mg and 5 mg 4 mg
ELOCON SINGULAIR SINGULAIR SINGULAR GRANULES
Drug
Dosage Form Extended-release Capsules Extended-release Capsules
Strength 30 mg, 60 mg, 90 mg and 120 mg 45 mg and 75 mg 30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mg 60 mg/2.4 mg
RLD
ANDA Approval Date
Approval Letter
Morphine Sulfate
AVINZA
Morphine Sulfate
AVINZA
7/30/2009
Morphine Sulfate and Extended-release Naltrexone Hydrochloride Capsules
EMBEDA
5/28/2010
Morphine Sulfate and Extended-release Naltrexone Hydrochloride Capsules Morphine Sulfate and Extended-release Naltrexone Hydrochloride Capsules Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride Mycophenolic Acid Mycophenolic Acid Mycophenolic Mofetil Mycophenolic Mofetil Mycophenolic Mofetil Ophthalmic Solution/Drops
EMBEDA
5/25/2010
100 mg/4 mg
EMBEDA
5/3/2010
0.50%
VIGAMOX MOXEZA
12/22/2005 2/29/2012 Likely Prior to 12/8/2003 6/4/2009 2/2/2009 On or After 12/8/2003 On or After 12/8/2003 3/25/2011 4/22/2009 4/22/2009 ANDA No. 090499 ANDA No. 090419
Tablets Delayed-release Tablets Delayed-release Tablets Tablets Capsules
400 mg
AVELOX
180 mg 360 mg 500 mg 250 mg
MYFORTIC MYFORTIC CELLCEPT CELLCEPT CELLCEPT
For Oral Suspension 200 mg/mL
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Granted (Shared)
Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months - FDC Act 505(j)(5)(D)(i)(IV)), but Citizen Petition Extension Applied - FDC Act 505(q)(1)(G)) Exclusivity Granted (Pre-MMA; Shared) (Expiration 12/14/2004) Exclusivity Granted (Pre-MMA;Shared) (Expiration 5/29/2004)
Exclusivity Granted (Pre-MMA; Shared) Selective Waiver of Exclusivity - See ANDA No. 076269 Exclusivity Granted (Pre-MMA;Shared)
Exclusivity Granted (Expiration 3/28/2012) Tentative Approval(s) Granted
Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Expiration 7/1/2012)
Exclusivity Decision Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted/Forfeited (180-Day Punt; PreMMA/MMA-Straddle; Failure to Obtain Tentative Approval in 30 Months - FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Expiration 1/22/2008; 100 mg & 200 mg)
Exclusivity Granted/Forfeited (180-Day Punt) (25 mg; Failure to Obtain Tentative Approval in 30 Months FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Relinquished (Pre-MMA) 50 mg; See ANDA No. 076969 Exclusivity Granted
Exclusivity Granted
Exclusivity Decision Exclusivity Granted/Forfeited (180-Day Punt) (Expiration 12/24/2010) (Failure-to-Market Delisting FDC Act 505(j)(5)(D)(i)(I)) Exclusivity Granted (QI Act Shared)
Exclusivity Granted (QI Act Shared)
Tentative Approval(s) Granted (80 mg)
Tentative Approval(s) Granted Tentative Approval(s) Granted Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Expiration 7/16/2003; 15 mg & 30 mg strengths) (Exclusivity Granted for 45 mg, but expired) See ANDA No. 076122 Exclusivity Granted (Pre-MMA) (7.5 mg; Suitability Petition - Docket No. 2002P-0249)
Exclusivity Decision Exclusivity Granted (Pre-MMA) (Expiration 6/14/2004; 15 mg & 30 mg strengths) Exclusivity Granted (Pre-MMA; Shared) (Expiration 2/28/2006; 45 mg strength) Exclusivity Granted (Pre-MMA; Shared) (Expiration 2/28/2006; 45 mg strength) Exclusivity Granted (Pre-MMA) (Expiration 9/26/2012) (Exclusivity Triggered By Authorized Generic Marketing) FDA Letter Decision Exclusivity Granted (Pre-MMA) (Expiration 9/21/2003)
No Exclusivity Granted (Forfeiture)
Exclusivity Relinquished (Pre-MMA) See ANDA No. 076679 Exclusivity Granted (Expiration 11/19/2005) Exclusivity Forfeited (Multiple ANDAs Approved Upon Patent/PED Expiration) Exclusivity Forfeited (Multiple ANDAs Approved Upon Patent/PED Expiration) Exclusivity Forfeited (Amended Patent Certification FDC Act 505(j)(5)(D)(i)(III))
Tentative Approval(s) Granted Exclusivity Granted Exclusivity Granted

Drug Dosage Form Strength RLD Date of Submission ANDA Approval Date 5/26/2000 Approval Letter ANDA No. 075189
Nabumetone
Tablets
500 mg and 750 mg
RELAFEN
Prior to 12/8/2003
6/6/2000
ANDA No. 075179
9/24/2001
ANDA No. 075189
Naproxen Sodium
375 mg (base) and 500 mg (base) 375 mg/20 mg and 500 mg/20 mg 500 mg/85 mg
NAPRELAN
Prior to 12/8/2003
Naproxen and Esomeprazole Magnesium Naproxen Sodium and Sumatriptan Succinate
Delayed-release Tablet Tablets
VIMOVO
11/5/2010
TREXIMET
7/23/2008 ANDA No. 077463
9/9/2009
Nateglinide
Tablets
60 mg and 120 mg
STARLIX
12/22/2004
9/9/2009
ANDA No. 077467
9/9/2009
ANDA No. 077461
Nateglinide
Tablets
mg Strength
STARLIX
12/22/2004 Date of Submission ANDA Approval Date 9/9/2009 Approval ANDA No. Letter 077461
Drug
Dosage Form
RLD
Nebivolol Hydrochloride
Tablets
2.5 mg, 5 mg, 10 mg, and 20 mg 50 mg, 100 mg, 150 mg 200 mg and 250 mg
BYSTOLIC
12/19/2011
Nefazodone Hydrochloride
Tablets
SERZONE
Prior to 12/8/2003
4/14/2005 Niacin Extended-release Tablets 500 mg, 750 mg and 1000 mg NIASPAN Prior to 12/8/2003 4/26/2005
ANDA No. 076250
ANDA No. 076378
Niacin and Simvastatin
Extended-release Tablets Extended-release Tablets Extended-release Tablets Extended-release Tablets Extended-release Tablets
500 mg/20 mg
SIMCOR
2/12/2010
Niacin and Simvastatin Niacin and Simvastatin Niacin and Simvastatin Niacin and Simvastatin
750 mg/20 mg 1000 mg/20 mg 1000 mg/40 mg 500 mg/40 mg 2.5 mg/mL, 10 mL Ampoules 7 mg/day, 14 mg/day and 21 mg/day 2 mg and 4 mg
SIMCOR SIMCOR SIMCOR SIMCOR
2/17/2010 9/17/2009 2/4/2011 2/9/2011
Nicardipine Hydrochloride Injection
CARDENE
12/27/2006
Nicotine
Transdermal System
HABITROL
Prior to 12/8/2003 Post 12/8/2003 ANDA No. 077007
Nicotine Polacrilex
Troche/Lozenge
COMMIT
1/31/2006
Drug Nifedipine
Dosage Form Capsules
Strength 10 mg and 20 mg
RLD PROCARDIA
3/10/2000
ANDA No. 075128
Nifedipine
ADALAT CC
Prior to 12/8/2003
12/4/2000
ANDA No. 075269
8/16/2002
ANDA No. 076070 ANDA No. 075108 ANDA No. 075289 ANDA No. 075414 ANDA No. 091001
12/17/1999
Nifedipine
PROCARDIA XL
Prior to 12/8/2003
9/27/2000
3/23/2004
Nisoldipine
Extended-release Tablets Extended-release Tablets Extended-release Tablets Extended-release Tablets
8.5 mg and 17 mg 20 mg and 30 mg 25.5 mg and 34 mg
SULAR
3/2/2009
1/26/2011
Nisoldipine
SULAR
11/7/2007
Nisoldipine
SULAR
11/28/2008
1/26/2011
ANDA No. 091001
Nisoldipine
40 mg
SULAR
6/11/2007
Drug Nitrofurantoin Monohydrate/ Macrocrystals Nitroglycerin
Dosage Form
Strength
RLD
Capsules
75 mg/25 mg
MACROBID
Sublingual Tablets Transdermal System
0.3 mg, 0.4 mg and 0.6 mg 0.1 mg/hr 0.1 mg/hr, 0.2 mg/hr, 0.3 mg/hr, 0.4 mg/hr, 0.6 mg/hr and 0.8 mg/hr
NITROSTAT
10/19/2005 Prior to 12/8/2003
Nitroglycerin
TRANSDERM-NITRO
Nitroglycerin
Transdermal System
NITRO-DUR
Prior to 12/8/2003
Nitroglycerin
Sublingual Spray
400 mcg/spray, 4.9 g and 12 g bottles
NITROLINGUAL PUMPSPRAY
4/17/2012
Nizatidine
Capsules
150 mg and 300 mg 15 mg/mL
AXID
Prior to 12/8/2003 5/14/2008 11/18/2009 ANDA No. 090576
Nizatidine
Oral Solution
AXID
Norelgestromin and Ethinyl Estradiol
Transdermal System
0.15 mg/0.02 mg per 24 hours
ORTHO EVRA
3/22/2007
Norethindrone Acetate/ Ethinyl Estradiol
Tablets
1 mg/0.005 mg
FEMHRT
Prior to 12/8/2003
11/6/2009
ANDA No. 076221
Drug
Dosage Form
Strength 1 mg/ 0.02 mg, 1 mg/0.03 mg and 1 mg /0.035 mg 1 mg/0.02 mg, 1 mg/ 0.03 mg and 1 mg /0.035 mg
RLD
ANDA Approval Date
Tablets
ESTROSTEP FE
10/26/2007
Tablets
ESTROSTEP 21
Prior to 12/8/2003
10/26/2007
ANDA No. 076405
Norethindrone Acetate/ Ethinyl Estradiol and Ferrous Fumarate Norethindrone Acetate and Ethinyl Estradiol / Ethinyl Estradiol and Ferrous Fumarate Norethindrone and Ethinyl Estradiol and Ferrous Fumarate Norethindrone and Ethinyl Estradiol and Ferrous Fumarate
Tablets
1 mg/0.02 mg and 75 mg
LOESTRIN 24 FE
4/17/2006
9/1/2009
ANDA No. 078267
Tablets
1 mg/0.01 mg, 0.01 mg and 75 mg
LO LOESTRIN FE
4/29/2011
Chewable Tablets
0.4 mg/0.035 mg
OVCON-35 FE FEMCON FE NDA 21490
4/27/2007
8/5/2010
ANDA No. 078965
Chewable Tablets
0.8 mg/0.025 mg and 75 mg 0.5 mg/ 0.035 mg, 0.75 mg/ 0.035 mg and 1 mg /0.035 mg
GENERESS FE
8/5/2011
Norethindrone/ Ethinyl Estradiol
Tablets
ORTHO-NOVUM 7/7/7, 21 AND 28 DAY
Prior to 12/8/2003
8/30/2002
ANDA No. 075478
Norgestimate/ Ethinyl Estradiol
Tablets
0.18 mg /0.025 mg, 0.215 mg ORTHO TRI-CYCLEN /0.025 mg and LO, 28 DAY 0.25 mg /0.025 mg
Prior to 12/8/2003
6/29/2009
ANDA No. 076784
Drug
Dosage Form
Strength
RLD
Date of Submission
Norgestimate/ Ethinyl Estradiol
Tablets
0.18 mg /0.035 mg, 0.215 mg ORTHO TRI/0.035 mg and CYCLEN, 21 AND 28 0.25 mg /0.035 DAY mg
Prior to 12/8/2003
ANDA Approval Date 12/18/2002 (Rescinded; Consent Judgment & Order); 12/29/2003 (Reapproved)
Approval Letter
ANDA No. 075808
Nortriptyline Hydrochloride
Capsules
10 mg, 25 mg, 50 mg and 75 mg
PAMELOR
Prior to 12/8/2003
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Decision Exclusivity Granted (Pre-MMA) (Expired 2/16/2002; 500 mg strength)
Exclusivity Granted (Pre-MMA) (Expired 2/23/2002; 750 mg strength)
Exclusivity Granted (Pre-MMA) (Expired 2/23/2002; 750 mg strength) (Remainder of 180-day exclusivity "selectively transferred" from ANDA No. 75-179)
Tentative Approval(s) Granted Exclusivity Granted (Shared)
Exclusivity Decision FDA Letter Decision
Exclusivity Granted (Pre-MMA) (500 mg & 750 mg)
Exclusivity Decision Exclusivity Granted (Pre-MMA) (Expiration 3/2/1991; 10 mg strength) Exclusivity Presumably Granted (Pre-MMA) (30 mg) FTC Consent Order Exclusivity Granted (Pre-MMA) (Expiration 6/5/2001; 60 mg) FTC Consent Order Exclusivity Granted (Pre-MMA) (90 mg)
No Exclusivity Granted (Pre-MMA) (30 mg) FDA Petition Response Docket No. 2000P-1446 Exclusivity Granted (Pre-MMA) (60 mg)
Exclusivity Granted & Relinquished (Pre-MMA) (90 mg) Exclusivity Granted
No Exclusivity Granted (Forfeited)
Exclusivity Granted
Exclusivity Presumably Forfeited - Patent Expiration (FDC Act 505(j)(5)(D)(i)(VI))
No Exclusivity Granted (Pre-MMA) Exclusivity Granted
No Exclusivity Granted (Pre-MMA) (Applicant did not maintain a consistent PIV certification)
Exclusivity Decision No Exclusivity Granted (Pre-MMA) (Applicant did not maintain a consistent PIV certification)
No Exclusivity Granted (Pre-MMA) (Applicant did not maintain a consistent PIV certification)
Exclusivity Presumably Granted (Pre-MMA)
Exclusivity Decision No Exclusivity Granted (Pre-MMA) - (28-day) (Patent Expiration & Conversion to Paragraph III)

Drug Dosage Form Strength 0.05 mg /mL, 0.1 mg /mL and 0.5 mg/mL, 1 mL vials 0.2 mg/mL and 1 mg /mL, 5 mL vials RLD SANDOSTATIN (PRESERVATIVE FREE) Date of Submission Prior to 12/8/2003 ANDA Approval Date Approval Letter ANDA No. 076313
Octreotide Acetate
Injection
3/28/2005
Octreotide Acetate
Injection
SANDOSTATIN
Prior to 12/8/2003
4/8/2005
ANDA No. 076330
Octreotide Acetate
Injection
0.05 mg/mL (base), 0.1 mg/mL (base) and 0.5 mg/mL (base) packaged in 1 mL pre-filled syringes (preservative free) 0.30% 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg
OCTREOTIDE ACETATE INJECTION
1/17/2008
Ofloxacin
Otic Solution
FLOXIN
Prior to 12/8/2003 Prior to 12/8/2003
9/28/2007
ANDA No. 076527 ANDA No. 076000
Olanzapine
Tablets
ZYPREXA
10/24/2011
Olanzapine
Tablets
20 mg
ZYPREXA
Prior to 12/8/2003 Prior to 12/8/2003
10/24/2011
ANDA No. 076133
Olanzapine
5 mg, 10 mg, Orally Disintegrating 15 mg and 20 Tablets mg
ZYPREXA ZYDIS
Drug
Dosage Form
Strength
RLD
ANDA Approval Date
Approval Letter
Olanzapine and Capsules Fluoxetine Hydrochloride
3 mg/25 mg 6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg 5 mg, 20 mg and 40 mg 20 mg/12.5 mg 40 mg/12.5 mg and 40 mg/25 mg 0.665 mg/ Spray
SYMBYAX
Olanzapine and Capsules Fluoxetine Hydrochloride
SYMBYAX
1/10/2005
6/19/2012
ANDA No. 077528
Olmesartan Medoxomil Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide Olopatadine Hydrochloride Olopatadine Hydrochloride Olopatadine Hydrochloride Omega-3-Acid Ethyl Esters
Tablets
BENICAR
4/25/2006
Tablets
BENICAR HCT
5/11/2007
Tablets
BENICAR HCT
2/15/2007
Nasal Spray
PATANASE
6/29/2009
PATANOL
7/17/2006
PATADAY
9/8/2008
Capsules
1g
LOVAZA
11/10/2008
11/16/2001 & 5/30/2008 Omeprazole Delayed-release Capsules 10 mg, 20 mg and 40 mg PRILOSEC Prior to 12/8/2003
ANDA No. 075347
Drug
Dosage Form
Strength 20 mg/1100 mg and 40 mg/1100 mg 20 mg/1100 mg 20mg/1680mg per packet 40 mg/1680 mg per packet
RLD
Omeprazole and Sodium Capsules Bicarbonate
ZEGERID
Omeprazole and Sodium Capsules Bicarbonate Omeprazole and Sodium Powder for Oral Bicarbonate Suspension Omeprazole and Sodium Powder for Oral Bicarbonate Suspension
ZEGERID OTC
4/20/2010
ZEGERID
11/13/2007
ZEGERID
8/24/2007
Omeprazole Magnesium
20 mg
PRILOSEC OTC
3/19/2007
6/5/2009
ANDA No. 078878
Ondansetron Hydrochloride
Injection
2 mg/mL, 2 mL vials (Preservative free) 2 mg/mL, 20 mL vials 0.64 mg/mL, 50 mL container (plastic) 4 mg/5 mL
ZOFRAN
Prior to 12/8/2003
Injection
ZOFRAN
Prior to 12/8/2003
Ondansetron Hydrochloride Ondansetron Hydrochloride Ondansetron Hydrochloride
Injection
ZOFRAN IN PLASTIC CONTAINER
Prior to 12/8/2003 ANDA No. 076960 ANDA No. 076506
Oral Solution
ZOFRAN
12/20/2004 Prior to 12/8/2003
12/26/2006
Orally Disintegrating 4 mg and 8 mg Tablets
ZOFRAN ODT
12/26/2006
Orally Disintegrating 16 mg and 24 Tablets mg
ZOFRAN ODT
11/24/2004
12/26/2006
ANDA No. 077406
Drug Ondansetron Hydrochloride
Dosage Form Strength Orally Disintegrating 16 mg and 24 Tablets mg
RLD ZOFRAN ODT
12/26/2006 Ondansetron Hydrochloride Tablets 4 mg, 8 mg, 16 mg, and 24 mg ZOFRAN Prior to 12/8/2003 12/26/2006
ANDA No. 076183
ANDA No. 076559
Orlistat
Capsules
60 mg
ALLI
9/8/2010
Oseltamivir Phosphate
Capsules
30 mg and 45 mg
TAMIFLU
8/2/2011
Oseltamivir Phosphate
Capsule
75 mg
TAMIFLU
11/15/2010
8/7/2009 Oxaliplatin Injection 5 mg/mL, 10 mL and 20 mL vials ELOXATIN 2/9/2007 8/7/2009
ANDA No. 078812
ANDA No. 078813
Oxaliplatin
Injection
5 mg/mL, 40 mL vial
ELOXATIN
3/23/2011
8/7/2009 50 mg/vial and 100 mg/vial
ANDA No. 078810 ANDA No. 078818
Oxaliplatin
For Injection
ELOXATIN
2/9/2007
8/7/2009
Oxaliplatin Drug
For Injection Dosage Form
50 mg/vial and 100 mg/vial Strength
ELOXATIN RLD
2/9/2007 Date of Submission
Oxaliplatin Oxandrolone
Injection Tablets
200 mg/40 mL 2.5 mg and 10 mg 10 mg, 15 mg and 30 mg
ELOXATIN OXANDRIN
7/16/2007 6/19/2006 Prior to 12/8/2003 ANDA No. 077794 ANDA No. 077795 ANDA No. 077801 ANDA No. 077802 ANDA No. 078005 ANDA No. 078069 ANDA No. 078734
Oxazepam
Capsules
SERAX
10/9/2007
10/9/2007
Oxcarbazepine
Tablets
150 mg, 300 mg and 600 mg
11/15/2007 TRILEPTAL 5/5/2006 10/9/2007
12/11/2007
1/11/2008
Oxcarbazepine
Oral Suspension Transdermal System Extendedrelease
300 mg/5 mL
TRILEPTAL
12/26/2006
6/26/2009
Oxybutynin
3.9 mg/24 hrs
OXYTROL
8/19/2008
Drug
Dosage Form
Strength
RLD
Date of Submission
Oxybutynin Chloride
DITROPAN XL
Prior to 12/8/2003
11/9/2006
ANDA No. 076644
11/9/2006
ANDA No. 076745
3/23/2004 Extended-release Tablets 10 mg, 20 mg, 40 mg, 80 mg and 160 mg OXYCONTIN (NDA 020553) Prior to 12/8/2003 3/24/2004 (2/7/2007 Converted to a Tentative Approval)
ANDA No. 076168
Oxycodone
ANDA No. 075923
Oxycodone Hydrochloride Oxycodone Hydrochloride Oxycodone Hydrochloride Oxycodone Hydrochloride Oxycodone Hydrochloride Oxycodone Hydrochloride Oxycodone Hydrochloride Oxycodone Hydrochloride
Extended-release Tablets Extended-release Tablets Extended-release Tablet Extended-release Tablet Extended-release Tablet Extended-release Tablet Extended-release Tablet Tablets
15 mg 30 mg and 60 mg 10 mg 15 mg 20 mg 30 mg, 60 mg and 80 mg 40 mg 5 mg and 7.5 mg
OXYCONTIN (NDA 020553) OXYCONTIN (NDA 020553) OXYCONTIN (NDA 022272) OXYCONTIN (NDA 022272) OXYCONTIN (NDA 022272) OXYCONTIN (NDA 022272) OXYCONTIN (NDA 022272) OXECTA
2/15/2007 1/3/2007 10/25/2010 10/28/2010 10/29/2010 10/18/2010 10/4/2010 2/8/2012
Drug Oxymorphone Hydrochloride Oxymorphone Hydrochloride
Dosage Form Extended-release Tablets Extended-release Tablets
Strength 5 mg, 10 mg, 20 mg and 40 mg 7.5 mg and 15 mg
RLD
OPANA ER
OPANA ER
5/29/2008
12/13/2010
Oxymorphone Hydrochloride
30 mg
OPANA ER
6/12/2008
7/22/2010
ANDA No. 079087
5 mg
OPANA ER (NDA 201655)
3/26/2012
7.5 mg, 10 mg, and 15 mg
3/23/2012
20 mg, 30 mg, 40 mg
4/3/2012
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Granted (Expiration 3/16/2008) Exclusivity Granted (Expiration 4/21/2012)
Exclusivity Forfeited (Patent Expiration - FDC Act 505(j)(5)(D)(i)(VI)) Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA; Shared Exclusivity) (Expiration 1/21/2009; 40 mg)
Exclusivity Relinquished (Pre-MMA; Shared Exclusivity) (10 mg, 20 mg) See ANDA No. 75-410 FDA Letter Decision
Exclusivity Granted (Suitability Petition) (Expiration 6/7/2010) Suitability Petition - Docket No. 2004P-0373)
Exclusivity Granted (Expiration 6/25/2007) Exclusivity Granted (Pre-MMA) (Expiration 6/24/2007)
Exclusivity Granted
Exclusivity Decision Suitability Petition - FDA Docket No. 2004P-0056 Exclusivity Granted (Pre-MMA) (Expiration 6/24/2007; 4 mg, 8 mg, and 24, mg) Exclusivity Granted (Pre-MMA) (16 mg) Suitability Petition - FDA Docket No. 2001P-0492
Exclusivity Decision Exclusivity Granted (Shared)
No Exclusivity Granted (Presumably Forfeited)
Exclusivity Granted (Shared) (Expiration4/6/2008)
Exclusivity Granted
Exclusivity Decision Exclusivity Granted (Pre-MMA) (Expiration 5/9/2007; 5 mg)
Exclusivity Granted (Pre-MMA) (Expiration 12/4/2005; 10 mg, 20 mg, and 40 mg)
Exclusivity Granted

Drug Dosage Form Strength 6 mg/mL, 5 mL, 16.7 mL, 25 mL, 33.3 mL and 50 mL vials 0.05 mg/mL, 1.5 mL and 5 mL vials 30 mg/vial, 60 mg/vial and 90 mg/vial 30 mg/vial, 60 mg/vial and 90 mg/vial 40 mg/vial RLD Date of Submission ANDA Approval Date Approval Letter
Paclitaxel
Injection
TAXOL
Prior to 12/8/2003
1/25/2002
ANDA No. 075184
Palonosetron Hydrochloride
Injection
ALOXI
5/27/2011
Pamidronate Disodium
For Injection
AREDIA
Prior to 12/8/2003
4/30/2001
ANDA No. 075290
Pamidronate Disodium
Injection
AREDIA
Prior to 12/8/2003
6/27/2002
ANDA No. 075841
Pantoprazole Sodium
For Injection
PROTONIX IV
4/7/2005 8/2/2007 ANDA No. 077056 ANDA No. 077058
Pantoprazole Sodium
Delayed-release Tablets
20 mg and 40 mg
PROTONIX
2/2/2004 9/10/2007
Paricalcitol
Injection
0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials
ZEMPLAR
11/28/2008
7/27/2011
ANDA No. 091108
Drug Paricalcitol
Strength 1 mcg and 2 mcg 4 mcg 10 mg and 20 mg 10 mg/5 mL 10 mg, 20 mg, 30 mg and 40 mg 12.5 mg and 25 mg 37.5 mg
RLD ZEMPLAR
ANDA Approval Date
Approval Letter
Paricalcitol
Capsules
ZEMPLAR PAXIL PAXIL
8/25/2008 Prior to 12/8/2003 2/10/2005 12/4/2006 ANDA No. 077395 ANDA No. 075356
Paroxetine Hydrochloride Capsules Paroxetine Hydrochloride Oral Suspension
Paroxetine Hydrochloride Tablets
PAXIL
Prior to 12/8/2003
7/30/2003
Paroxetine Hydrochloride
Extended-release Tablets Extended-release Tablets For Injection
PAXIL CR
9/9/2005
6/29/2007
ANDA No. 077873 ANDA No. 091427
Paroxetine Hydrochloride
PAXIL CR
5/19/2009
4/14/2011
Pemetrexed Disodium
100 mg/vial
ALIMTA
7/1/2008
Pemetrexed Disodium
For Injection
500 mg/vial
ALIMTA
2/4/2008
Pemetrexed disodium
For Injection
1000 mg/vial
ALIMTA
6/27/2012
Pergolide Mesylate
Tablets
0.05 mg, 0.25 mg and 1 mg 2 mg, 4 mg and 8 mg
PERMAX
Prior to 12/8/2003
11/27/2002
ANDA No. 076061
Perindopril Erbumine
Tablets
ACEON
6/6/2006
8/17/2012 Pioglitazone Hydrochloride Tablets 15 mg, 30 mg and 45 mg ACTOS Prior to 12/8/2003
ANDA No. 076801
Drug Pioglitazone Hydrochloride
Dosage Form Tablets
Strength 15 mg, 30 mg and 45 mg
RLD ACTOS
ANDA Approval Date
Pioglitazone Hydrochloride and Glimepiride
Tablets
30 mg/2 mg and 30 mg/4 mg 15 mg/1000 mg and 30 mg/1000 mg
DUETACT
12/22/2009
1/4/2013
ANDA No. 201049
Pioglitazone Extended-release Hydrochloride and Tablets Metformin Hydrochloride
ACTOPLUS MET XR
9/23/2011
Pioglitazone Hydrochloride and Tablets Metformin Hydrochloride
15 mg/500 mg and 15 mg/850 mg
ACTOPLUS MET
3/6/2008
6/26/2012 ANDA No. (Initially approved 090406 on 2/25/2011)
Piperacillin Sodium and Tazobactam Sodium
For Injection
2.25 g/vial, 3.375 g/vial, 4.5 g/vial
ZOSYN
PIV received prior to 2/5/2009 PIV received prior to 2/5/2009
9/15/2009
ANDA No. 065386
Piperacillin Sodium and Tazobactam Sodium
For Injection
40.5 g/vial
ZOSYN
9/15/2009
ANDA No. 065446
Piperacillin Sodium and Tazobactam Sodium Polyethylene Glycol 3350
For Injection
12 g/1.5 g per vial (pharmacy bulk) 17g/Scoopful
ZOSYN
12/6/2011
Powder for Oral Solution
MIRALAX
Prior to 12/8/2003
210 g, 5.6 g, Polyethylene Glycol 3350, For Oral Solution 0.74 g, 2.86 g Sodium Chloride, Sodium and Delayed-release and 5 mg (1 Bicarbonate, Potassium Tablet Tablet Chloride and Bisacodyl Regimen)
HALFLYTELY AND BISACODYL
7/30/2010
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
210 g, 5.6 g, Polyethylene Glycol 3350, For Oral Solution 0.74 g, 2.86 g Sodium Chloride, Sodium and Delayed-release and 5 mg (2 Bicarbonate, Potassium Tablets Tablet Chloride and Bisacodyl Regimen) Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium For Oral Solution Chloride, Sodium Ascorbate and Ascorbic Acid Posaconazole Oral Suspension Extended-release Capsules Extended-release Tablets 100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch
HALFLYTELY AND BISACODYL
1/28/2008
MOVIPREP
11/27/2007
40 mg/mL 8 mEq and 10 mEq 10 mEq and 20 mEq
NOXAFIL
2/28/2011 Prior to 12/8/2003 Prior to 12/8/2003 ANDA No. 074726
Potassium Chloride
MICRO K
Potassium Chloride
K-DUR
11/20/1998
Potassium Chloride
15 mEq
K-DUR
Prior to 12/8/2003
6/6/2003
ANDA No. 074726
Pramipexole Dihydrochloride
Tablets
0.125 mg, 0.5 mg, 1 mg and 1.5 mg
MIRAPEX
6/24/2005
2/19/2008
ANDA No. 077724
Pramipexole Dihydrochloride Pramipexole Dihydrochloride Pramipexole Dihydrochloride
Tablets
0.25 mg
MIRAPEX
5/27/2005
2/19/2008
ANDA No. 077724 ANDA No 090764
Tablets
0.75 mg 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg
MIRAPEX
7/31/2008
4/9/2010
MIRAPEX ER
6/1/2010
Drug Pramipexole Dihydrochloride
Strength 2.25 mg and 3.75 mg
RLD
ANDA Approval Date
Approval Letter
MIRAPEX ER
4/24/2006 Pravastatin Sodium Tablets 10 mg, 20 mg, 40 mg and 80 mg PRAVACHOL Prior to 12/8/2003 4/23/2007
Pravastatin Sodium
Tablets
30 mg 1 mg, 2 mg and 5 mg
PRAVACHOL
6/1/2005 Prior to 12/8/2003
11/21/2006
Prazosin Hydrochloride
Capsules
MINIPRESS
6/28/2002 Prednisolone Sodium Phosphate Oral Solution 5 mg(base)/ 5 mL and 15 mg (base)/ 5 mL PEDIAPRED Prior to 12/8/2003 12/14/2000
ANDA No. 075099
ANDA No. 075117
Prednisolone Sodium Phosphate
Orally Disintegrating 10 mg, 15 mg Tablets and 30 mg
ORAPRED
7/22/2010
7/3/2012
ANDA No. 091040
Pregabalin
Capsules
25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
7/3/2012 LYRICA 12/30/2008 7/3/2012
ANDA No. 091219
ANDA No. 091221
Pregabalin
Capsules
Drug
Dosage Form
mg, 150 mg, 200 mg, 225 mg and 300 mgStrength
LYRICA
12/30/2008 Date of Submission ANDA Approval Date 7/3/2012 Approval Letter ANDA No. 091224
RLD
Pregabalin
Oral Solution Extended-release Capsules Extended-release Capsules
20 mg/mL
LYRICA
5/19/2010
Propafenone Propafenone Hydrochloride
325 mg 225 mg and 425 mg
RYTHMOL SR
11/7/2006 ANDA No. 078540
RYTHMOL SR
10/11/2006
10/18/2010
Propofol
Injection
10 mg/mL ; 20 mL, 50 mL and 100 mL vials and 20 mL syringe 60 mg, 80 mg, 120 mg and 160 mg
DIPRIVAN
Prior to 12/8/2003
1/4/1999
ANDA No. 075102
Propranolol Hydrochloride
INDERAL LA
Prior to 12/8/2003
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Granted (Pre-MMA) (Expiration 5/5/2002; 30 mg/vial & 90 mg/vial)
Exclusivity Relinquished (Pre-MMA) Suitability Petition - Docket Nos. 1999P-2252 & 2000P0091; See ANDA No. 76-153 Exclusivity Forfeited Exclusivity Granted (Shared) (Expiration 6/18/2008) Exclusivity Granted (Shared) (Expiration 6/18/2008) Exclusivity Granted
Exclusivity Granted (Expiration 6/10/2007) Exclusivity Granted (Pre-MMA; Shared) (Expiration 3/6/2004) FDA Letter Decision Exclusivity Granted (Expiration 11/10/2008)
Exclusivity Forfeited - Patent Expiration FDC Act 505(j)(5)(D)(i)(VI)) Exclusivity Granted (pre-MMA) (Expiration 2/13/2013)
Exclusivity Decision Exclusivity Granted (pre-MMA) - Triggered by Authorized Generic marketing Exclusivity selectively waived - ANDA No. 202467 Exclusivity Granted
Exclusivity Granted (Expiration 2/13/2013); FDA initially determined 180-day exclusivity was forfeited for Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)), but reversed the decision. See FDA 2/25/2011 ANDA Approval Letter Exclusivity Granted (Expiration 3/30/2010; 2.25 g/vial) (Expiration 3/28/2010; 3.375 g/vial) (Expiration 3/21/2010 4.5 g/vial) Exclusivity Granted (Expiration 4/27/2010)
Exclusivity Decision Tentative Approval(s) Granted, but RLD Withdrawn for Safety Reasons; No Exclusivity
No Exclusivity Presumably Granted (Pre-MMA) Exclusivity Granted (Pre-MMA) (Expiration 2/28/2002; 20 mEq strength)
Exclusivity Granted (Pre-MMA) (Expiration 10/21/2006; 10 mg, 20 mg, and 40 mg) Exclusivity Granted (Pre-MMA) (Expiration 12/17/2007; 80 mg)
Exclusivity Presumably Granted - Suitability Petition Docket No. 2004P-0216
Exclusivity Granted (Pre-MMA) (5 mg(base)/5 mL)
Exclusivity Granted (Pre-MMA) (Expiration 7/2/2001; 15 mg (base)/5 mL) (Suitability Petition ANDA)
Exclusivity Granted (Shared) (all strengths)
Exclusivity Forfeited (25 mg and 50 mg strengths) Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Forfeited (all strengths) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
Exclusivity Decision Exclusivity Forfeited (75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg strengths) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Pre-MMA) (Expiration 10/17/1999)
No Exclusivity Granted

Drug Quetiapine Fumarate Quetiapine Fumarate Quetiapine Fumarate Dosage Form Tablets Extended-release Tablets Extended-release Tablets Tablets Strength 25 mg 400 mg 150 mg 50 mg, 150 mg and 400 mg 100 mg, 200 mg and 300 mg 200 mg and 300 mg 50 mg RLD SEROQUEL SEROQUEL XR SEROQUEL XR Date of Submission 8/12/2005 6/18/2008 11/17/2008 ANDA Approval Date Approval Letter
Quetiapine Fumarate
SEROQUEL
2/12/2007
Quetiapine Fumarate
Tablets Extended-release Tablets Extended-release Tablets
SEROQUEL
2/21/2006
Quetiapine Fumarate
SEROQUEL XR
6/12/2008
Quetiapine Fumarate
SEROQUEL XR
10/17/2008
Quinapril Hydrochloride
Tablets
5 mg, 10 mg, 20 mg and 40 mg
ACCUPRIL
Prior to 12/8/2003
5/30/2003 (Converted to a Tentative Approval 4/11/2005; Reapproved 8/24/2007)
ANDA No. 075504
Quinapril Hydrochloride/ Hydrochlorothiazide
Tablets
10 mg/12.5 mg, 20 mg/12.5 mg and 20mg/25 mg
ACCURETIC
Prior to 12/8/2003
3/31/2004
ANDA No. 076374
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Decision Exclusivity Forfeited (Patent Expiration - FDC Act 505(j)(5)(D)(i)(VI)) Tentative Approval(s) Granted Tentative Approval(s) Granted Exclusivity Forfeited (Patent Expiration - FDC Act 505(j)(5)(D)(i)(VI)) Exclusivity Forfeited (Patent Expiration - FDC Act 505(j)(5)(D)(i)(VI)) Tentative Approval(s) Granted Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA) Exclusivity Later Relinquished- See ANDA No. 076607

Drug Dosage Form Delayed-release Tablets Strength RLD Date of Submission Prior to 12/8/2003 ANDA Approval Date 2/21/2007 Approval Letter ANDA No. 076822
Rabeprazole Sodium
20 mg
ACIPHEX
Regadenoson
Injection
0.08 mg/mL, 5 mL vial
LEXISCAN
4/10/2012
Raltegravir
Tablets
400 mg
ISENTRESS
10/12/2011 Prior to 12/8/2003 7/22/2009
Raloxifene Hydrochloride Tablets Ramelteon Tablets
60 mg 8 mg
EVISTA ROZEREM
10/24/2005 Ramipril Capsules 1.25 mg, 2.5 mg, 5 mg and 10 mg ALTACE Prior to 12/8/2003 6/9/2008
ANDA No. 076549
ANDA No. 077626
Ranitidine
Capsules
150 mg and 300 mg 25 mg/mL, 2 mL and 6 mL and 40 mL vials
ZANTAC
Prior to 12/8/2003
10/22/1997
ANDA No. 074655
Ranitidine
Injection
ZANTAC
Prior to 12/8/2003
Drug
Dosage Form
Strength
RLD
Ranitidine
Oral Solution
15 mg/mL
ZANTAC
6/21/1999 Ranitidine Tablets 75 mg, 150 mg and 300 mg ZANTAC Prior to 12/8/2003 8/22/1997
ANDA No. 074023
Ranitidine Hydrochloride Tablets Extended-release Tablets Tablets Tablets
150 mg 500 mg and 1000 mg 0.5 mg and 1 mg 0.5 mg, 1 mg and 2 mg 1 mg/500 mg and 2 mg/500 mg
ZANTAC 150 (NDA 21698/PRODUCT 002) RENEXA AZILECT PRANDIN
10/30/2007
Ranolazine Rasagiline Mesylate Repaglinide
5/17/2010 5/17/2010 2/10/2005
Repaglinide and Tablets Metformin Hydrochloride
PRANDIMET
4/9/2009
4/6/2004 Ribavirin Capsules 200 mg REBETOL Prior to 12/8/2003 4/6/2004
ANDA No. 076203
ANDA No. 076192
Risedronate Sodium
Tablets
5 mg, 30 mg and 35 mg 75 mg
ACTONEL
4/23/2004
10/5/2007
ANDA No. 077132
Risedronate Sodium
Tablets
ACTONEL
9/10/2007
Drug Risedronate Sodium
Dosage Form Tablets Delayed-release Tablets
Strength 150 mg
RLD ACTONEL
ANDA Approval Date
Approval Letter
Risedronate Sodium
35 mg
ATELVIA ACTONEL WITH CALCIUM RISPERDAL
7/19/2011
Risedronate Sodium with Tablets Calcium Carbonate Risperidone Oral Solution
35 mg; 500 mg
12/18/2007 Prior to 12/8/2003 Prior to 12/8/2003 ANDA No. 076440 ANDA No. 076228
1 mg/mL 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg
1/30/2009
Risperidone
Tablets
RISPERDAL
6/30/2008
Risperidone
Orally Disintegrating 0.25 mg Tablets Orally Disintegrating 0.5 mg, 1 mg Tablets and 2 mg Orally Disintegrating 3 mg and 4 mg Tablets Tablets 100 mg
RISPERDAL
4/11/2005 Likely On or After 12/8/2003 3/23/2005
4/30/2009
ANDA No. 077494
Risperidone
RISPERDAL
Risperidone
RISPERDAL
4/30/2009
ANDA No. 077494
Ritonavir
NORVIR
12/21/2010
10/22/2007
ANDA No. 077130
Rivastigmine Tartrate
Capsules
1.5 mg, 3 mg, 4.5 mg and 6 mg
EXELON
4/21/2004
10/22/2007
ANDA No. 077131
1/8/2008
ANDA No. 077129
Drug Rivastigmine Tartrate
Dosage Form Oral Solution Transdermal System Extendedrelease Tablets
Strength 2 mg/mL 4.6 mg/24 hr and 9.5 mg/24 hr 5 mg and 10 mg
RLD EXELON
ANDA Approval Date
Approval Letter
Rivastigmine
EXELON PATCH
4/27/2011 ANDA No. 077263 ANDA No. 078173
Rizatriptan Benzoate
MAXALT
9/2/2004
12/31/2012
Rizatriptan Benzoate
Orally Disintegrating 5 mg and 10 Tablets mg 12.5 mg, 25 mg and 50 mg
MAXALT-MLT
2/17/2006
12/31/2012
Rofecoxib
Tablets
VIOXX
Prior to 12/8/2003
Ropinirole Hydrochloride
2 mg
REQUIP XL
10/14/2008
5/17/2012
ANDA No. 090869
4 mg
REQUIP XL
10/31/2008
5/17/2012
ANDA No. 090869
6 mg
REQUIP XL
7/14/2009
5/17/2012
ANDA No. 090869
8 mg
REQUIP XL
11/3/2008
5/17/2012
ANDA No. 090869
Ropinirole Hydrochloride Tablets
0.25 mg, 0.5 mg, 1 mg and 2 mg 3 mg, 4 mg and 5 mg
REQUIP
12/22/2004
Ropinirole Hydrochloride Tablets
REQUIP
2/4/2005
Drug Ropinirole Hydrochloride Ropinirole Hydrochloride
Dosage Form Extended-release Tablets Extended-release Tablets
Strength 3 mg 12 mg 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials 2 mg, 4 mg and 8 mg 1 mg/ 500 mg, 2 mg/ 500mg, 4 mg/ 500 mg, 2 mg/ 1000 mg and 4 mg/ 1000 mg 5 mg, 10 mg, 20 mg and 40 mg 7
RLD REQUIP XL REQUIP XL
ANDA Approval Date
Approval Letter
5/17/2012
ANDA No. 090869
Ropivacaine Hydrochloride
Injection
NAROPIN
11/13/2006
Rosiglitazone Maleate
Tablets
AVANDIA
Prior to 12/8/2003
1/25/2013
ANDA No. 076747
Rosiglitazone Maleate and Metformin Hydrochloride
Tablets
AVANDAMET
10/22/2004
Rosuvastatin Calcium
Tablets
CRESTOR
8/13/200
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Decision Exclusivity Granted (Pre-MMA; Shared)
Exclusivity Granted (Pre-MMA) (Expiration 6/7/2008) FDA Letter Decision Exclusivity Granted (Pre-MMA) (Expiration 12/7/2008) (Second period granted based on new patent(s))
Exclusivity Lost (Pre-MMA) - Patent Expiration
Exclusivity Granted (Pre-MMA) - (Expiration 1/14/2000; 75 mg strength) Exclusivity Granted (Pre-MMA) and Selectively Waived - (Expiration 8/29/1997; 150 mg & 300 mg strengths) See Docket No. 2004P-0227 Exclusivity Presumably Forfeited (Patent Expiration FDC Act 505(j)(5)(D)(i)(VI))
Exclusivity Granted
Exclusivity Forfeited (Application Withdrawn (FDC Act 505(j)(5)(D)(i)(II)) Exclusivity Granted (Pre-MMA) (Expiration 7/29/2009) Exclusivity Granted (Pre-MMA)
Exclusivity Relinquished (1 mg)
Exclusivity Forfeited (Patent Expiration - FDC Act 505(j)(5)(D)(i)(VI)) Exclusivity Granted
Exclusivity Granted (Expiration 6/6/2012) (Patent Expired on 6/6/2012) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Expiration 6/6/2012) (Patent Expired on 6/6/2012) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Expiration 6/6/2012) (Patent Expired on 6/6/2012) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Expiration 6/6/2012) (Patent Expired on 6/6/2012) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) No Exclusivity Granted (Forfeited)
Exclusivity Decision Exclusivity Forfeited (Application Withdrawn (FDC Act 505(j)(5)(D)(i)(II)) Exclusivity Granted (Expired 6/6/2012 Upon Patent Expiration) Tentative Approval(s) Granted
Exclusivity Granted (pre-MMA) Tentative Approval(s) Granted

Drug Dosage Form Strength RLD Date of Submission 12/8/2003 ANDA Approval Date 6/30/2006 Approval Letter ANDA No. 076934
Sertraline Hydrochloride
Oral Concentrate
20 mg/mL
ZOLOFT
Sertraline Hydrochloride
Tablets
25 mg, 50 mg and 100 mg 150 mg and 200 mg 800 mg 0.8 g/packet and 2.4 g/packet 400 mg and 800 mg
ZOLOFT
Prior to 12/8/2003 11/9/2005 12/4/2008
6/30/2006
ANDA No. 075719 ANDA No. 077977
Sertraline Hydrochloride Sevelamer Carbonate
Tablets Tablets Powder for Oral Suspension
ZOLOFT RENVELA
2/6/2007
Sevelamer Carbonate
RENVELA
12/30/2009
Sevelamer Hydrochloride Tablets
RENAGEL
5/22/2008 ANDA No. 075895 ANDA No. 077867
7/2/2002 Sevoflurane Inhalation 100%, 250 mL ULTANE Prior to 12/8/2003 5/2/2007
Sibutramine Hydrochloride Sildenafil Citrate Sildenafil Citrate
Capsules
10 mg and 15 mg 25 mg and 50 mg 100 mg
MERIDIA
8/14/2009
Tablets Tablets
VIAGRA VIAGRA
11/19/2004 10/25/2004
Drug Silver Sulfadiazine
Dosage Form Cream
Strength 1%
RLD SILVADENE
ANDA Approval Date
Approval Letter
6/23/2006 Simvastatin Tablets 5 mg, 10 mg, 20 mg, 40 mg and 80 mg ZOCOR Prior to 12/8/2003 6/23/2006
ANDA No. 076052
ANDA No. 076285
Sirolimus Sirolimus
Tablets Tablets
0.5 mg 1 mg and 2 mg
RAPAMUNE RAPAMUNE
8/25/2010 12/17/2009
Sodium Phosphate Monobasic Monohydrate and Sodium Tablets PhosphateDibasic Anhydrous, USP
1.102 g and 0.398 g
OSMOPREP
4/9/2008
Sodium Oxybate Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Solifenacin Succinate Sitagliptin Phosphate
Oral Solution
500 mg/mL 17.5 g/3.13 g/1.6 g per bottle 5 mg and 10 mg 25 mg, 50 mg and 100 mg 50 mg/500 mg and 50 mg/1000 mg
XYREM
7/8/2010
Oral Solution
SUPREP BOWEL PREP KIT VESICARE JANUVIA
11/8/2010
Tablets Tablets
4/8/2009 10/18/2010
Sitagliptin Phosphate and Tablets Metformin Hydrochloride
JANUMET
10/18/2010
Drug
Dosage Form
Strength 50 mg/500 mg and 50 mg/1000 mg 100 mg/1000 mg 100 mg/10 mg and 100 mg/40 mg 100 mg/10 mg and 100 mg/40 mg 6 mg/0.5 mL, 0.5 mL vials 6 mg/0.5 mL, 0.5 mL (prefilled syringes)
RLD
ANDA Approval Date
Approval Letter
Sitagliptin Phosphate and Extended-release Metformin Hydrochloride Capsules
JANUMET XR
Sitagliptin Phosphate and Extended-release Metformin Hydrochloride Tablets
JANUMET XR
10/22/2012
Sitagliptin and Simvastatin Phosphate
Tablets
JUVISYNC
6/19/2012
Sitagliptin and Simvastatin Phosphate
Tablets
JUVISYNC
6/25/2012
Sumatriptan Succinate
Injection
IMITREX
10/25/2004
Sumatriptan Succinate
Injection
IMITREX
5/9/2006
2/9/2009 Sumatriptan Succinate Tablets 25 mg, 50 mg and 100 mg IMITREX Prior to 12/8/2003 2/9/2009 12.5 mg, 25 mg, 37.5 mg and 50 mg
ANDA No. 076572
ANDA No. 076840
Sunitinib Malate
Capsules
SUTENT
1/26/2010
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Exclusivity Granted (Pre-MMA) (Second period)
Exclusivity Granted (Pre-MMA) (Expiration 12/20/2006; 5 mg, 10 mg, 20 mg, and 40 mg) Petition Decision - Docket Nos. 2005P-0008 & 2005P0046 Exclusivity Granted (Pre-MMA) (Expiration 12/20/2006; 80 mg)
Exclusivity Granted (Pre-MMA; Shared) (Expiration 8/8/2009; 100 mg)
Exclusivity Granted (Pre-MMA; Shared) (Expiration 8/8/2009; 25 mg, 50 mg, and 100 mg)

Drug Tacrolimus Tacrolimus Tadalafil Tadalafil Tadalafil Dosage Form Ointment Ointment Tablets Tablets Tablets Strength 0.03% 0.10% 2.5 mg x 5 mg, 10 mg and 20 mg 20 mg RLD PROTOPIC PROTOPIC CIALIS CIALIS ADCIRCA Date of Submission 11/22/2010 9/9/2010 10/14/2008 11/21/2007 10/15/2009 ANDA Approval Date Approval Letter
Tamoxifen Citrate
Tablets
10 mg and 20 mg
NOLVADEX
Prior to 12/8/2003
2/20/2003
ANDA No. 070929
Tamsulosin Hydrochloride
Capsules
0.4 mg
FLOMAX
12/20/2004
Telmisartan
Tablets
20 mg, 40 mg and 80 mg 80 mg/12.5 mg and 40 mg/12.5 mg 80 mg/25 mg 7.5 mg
MICARDIS
12/26/2006
Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide Temazepam
Tablets
MICARDIS HCT
12/31/2008
Tablets Capsules
MICARDIS HCT RESTORIL
2/27/2009 11/1/2006 9/8/2009 ANDA No. 078581
Drug Temozolomide
Strength 5 mg, 20 mg, 100 mg, and 250 mg 140 mg and 180 mg 25 mg/mL, 1.8 mL vial 300 mg 150 mg, 200 mg, and 250 mg 1 mg, 2 mg, 5 mg and 10 mg 1 mg, 2 mg, 5 mg and 10 mg
RLD TEMODAR
Temozolomide Temsirolimus Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate
Capsules Injection Tablets
TEMODAR TORISEL VIREAD
3/24/2008 5/25/2011 1/26/2010
3/1/2010
Tablets
VIREAD
5/17/2012
Terazosin Hydrochloride
Capsules
HYTRIN
Prior to 12/8/2003 Prior to 12/8/2003
3/30/1998
ANDA No. 074823 ANDA No. 074315
Terazosin Hydrochloride
Tablets
HYTRIN
12/31/1998
Terbinafine Hydrochloride Tablets
250 mg
LAMISIL
Prior to 12/8/2003 Prior to 12/8/2003 Prior to 12/8/2003 8/21/2008 12/19/2008 4/6/2012 ANDA No. 076737
Terfenadine
Tablets
60 mg
SELDANE
Testosterone
Gel
1%
ANDROGEL
1/27/2006
Testosterone Testosterone Testosterone
Gel Gel Metered-dose Pump Gel
1% 1% 2%
TESTIM ANDROGEL ANDROGEL
Drug Testosterone Thalidomide Thalidomide Tiagabine Hydrochloride
Dosage Form Gel Capsules Capsules Tablets
Strength 10 mg/actuation 50 mg and 100 mg 200 mg 2 mg and 4 mg
RLD FOTESTA THALOMID THALOMID GABITRIL
Date of Submission 8/14/2012 12/18/2006 9/25/2006 2/1/2005 Prior to 12/8/2003 6/15/2009 Prior to 12/8/2003 8/10/2007
ANDA Approval Date
Approval Letter
11/4/2011
ANDA No. 077555 ANDA No. 075089
Ticlopidine Hydrochloride Tablets
250 mg
TICLID
7/1/1999
Tigecycline Timolol Maleate
For Injection Ophthalmic Solution
50 mg per vial 0.25% and 0.5% 2 mg, 4 mg and 6 mg 300 mg/5 mL 2 mg and 4 mg
TYGACIL TIMOPTIC
Tizanidine Hydrochloride Capsules
ZANAFLEX
2/3/2012
ANDA No. 078868
Tobramycin Tolterodine Tartrate
Inhalation Solution Extended-release Capsules Tablets
TOBI DETROL LA
6/29/2009 7/30/2007 Likely On or After 12/8/2003 ANDA No. 076953
Tolterodine Tartrate
1 mg and 2 mg
DETROL
4/15/2009 Topiramate Capsules 15 mg and 25 mg TOPAMAX SPRINKLE 9/7/2005
ANDA No. 076448
4/15/2009
ANDA No. 077868
Topiramate
Capsules
mg
SPRINKLE
9/7/2005
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval 4/15/2009 Date
Approval ANDA No. Letter 077868
Topiramate
Tablets
25 mg, 100 mg and 200 mg
TOPAMAX
12/26/2001
9/11/2006 (Converted to a Tentative Approval on 7/27/2007 and Back to final Approval on 3/27/2009)
ANDA No. 076314
Topiramate
Tablets
50 mg
TOPAMAX
9/8/2005
Torsemide
Tablets
5 mg, 10 mg, 20 mg, and 100 mg
DEMADEX
Prior to 12/8/2003
5/14/2002
ANDA No. 076110
Tramadol Hydrochloride
Tablets
50 mg
ULTRAM
Prior to 12/8/2003 ANDA No. 078783 ANDA No. 078783
Extended-release Tablets Extended-release Tablets Extended-release Tablets Extended-release Tablets
100 mg
ULTRAM ER
1/8/2007
11/13/2009
200 mg
ULTRAM ER
3/28/2007
11/13/2009
300 mg 100 mg, 200 mg and 300 mg 1 mg, 2 mg and 4 mg
ULTRAM ER
9/25/2007 ANDA No. 091607
RYZOLT
6/18/2009
12/30/2011
Trandolapril
Tablets
MAVIK
10/4/2004
Drug
Dosage Form
Strength 2 mg/180 mg and 2 mg/240 mg 1 mg/240 mg
RLD
Approval Letter ANDA No. 079135 ANDA No. 079135 ANDA No. 079135 ANDA No. 202093
Trandolapril and Extended-release Verapamil Hydrochloride Tablets Trandolapril and Extended-release Verapamil Hydrochloride Tablets Trandolapril and Extended-release Verapamil Hydrochloride Tablets
TARKA
TARKA
2/20/2008
8/30/2010
4 mg/ 240 mg
TARKA
7/24/2007
5/5/2010
Tranexamic Acid
Tablets
650 mg
LYSTEDA
5/24/2011
12/27/2013
Travoprost Travoprost (Preserved)
Ophthalmic Solution 0.0040% Ophthalmic Solution 0.0040% 150 mg 150 mg and 300 mg 10 mg/mL, 20 mL vial 0.025%, 0.05% and 0.1%
TRAVATAN TRAVATAN Z DESYREL OLEPTRO REMODULIN
11/28/2008 2/19/2009 Prior to 12/8/2003 10/18/2010 12/2/2011 Prior to 12/8/2003 Prior to 12/8/2003
Trazodone Hydrochloride Tablets Trazodone Hydrochloride Treprostinil Sodium Extended-release Tablets Injection
Tretinoin
Cream
RETIN-A
Tretinoin
Gel
0.025%
RETIN-A
Tretinoin
Gel
0.040%
RETIN-A MICRO
12/20/2010
Tretinoin
Gel
0.100%
RETIN-A MICRO
7/8/2010
Drug
Dosage Form
Strength 0.055 mg/Spray 37.5 mg/25 mg and 75 mg/50 mg 60 mg
RLD
Triamcinolone Acetonide Nasal Spray
NASACORT AQ
Triamterene/ Hydrochlorothiazide
Tablets
MAXZIDE
Prior to 12/8/2003 ANDA No. 091289
Trospium Chloride
SANCTURA XR
3/2/2009
10/12/2012
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Tentative Approval(s) Granted No Exclusivity Granted (Pre-MMA) - Change from PIV to PIII; Petition Decision (1998P-0493) & Court Decision (Mylan Pharmaceuticals, Inc. v. Henney, 94 F. Supp. 2d 36 (D.D.C. 2000)) No Exclusivity Granted (Forfeiture)
Exclusivity Granted
Exclusivity Granted & Relinquished (Pre-MMA) FTC Order No Exclusivity Granted (Pre-MMA) - Patent Expiration
No Exclusivity Granted (Pre-MMA) (RLD Approval Withdrawn for Reasons of Safety) Exclusivity Granted (Pre-MMA) (subsequently relinquished)
Exclusivity Granted Exclusivity Granted (Pre-MMA) (Exclusivity Voided by Later Court Decision)
No Exclusivity Granted (Pre-MMA) Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Tentative Approval(s) Granted
Exclusivity Forfeited (Application Withdrawn (FDC Act 505(j)(5)(D)(i)(II)) Exclusivity Granted (Pre-MMA/MMA-Straddle) (Expiration 10/12/2009) Exclusivity Selectively Waived - ANDA No. 076575
FDA Letter Decision Exclusivity Granted (Pre-MMA/MMA-Straddle) (Expiration 10/12/2009)
Exclusivity Decision FDA Letter Decision Exclusivity Granted (Pre-MMA)
Exclusivity Granted (Pre-MMA) (Expiration 2/17/2003; 5 mg strength) (Expiration 12/10/2002; 10 mg & 100 mg strengths) (Expiration 12/7/2002; 20 mg strength)
Presumably No Exclusivity Granted - Conversion from PIV to section viii Statement Exclusivity Granted
Exclusivity Granted
Exclusivity Presumably Forfeited Exclusivity Granted (Expiration 6/27/2012)
Exclusivity Granted
Exclusivity Decision Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV))
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) (Expiration 04/10/2013)

Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker

Drug Valacyclovir Hydrochloride Valganciclovir hydrochloride Valganciclovir Hydrochloride Valsartan Dosage Form Tablets Strength 500 mg and 1000 mg 50 mg/mL RLD VALTREX Date of Submission Prior to 12/8/2003 3/21/2011 ANDA Approval Date 1/31/2007 Approval Letter ANDA No. 076588
For Oral Solution
VALCYTE
Tablets
450 mg 40 mg, 80 mg, 160 mg and 320 mg 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg 320 mg/12.5 mg and 320 mg/25 mg 2.5 mg 5 mg and 10 mg 20 mg
VALCYTE
12/27/2005 ANDA No. 077492
Tablets
DIOVAN
12/28/2004
Valsartan and Hydrochlorothiazide
Tablets
DIOVAN HCT
12/2/2005
9/21/2012
ANDA No. 078020
Valsartan and Hydrochlorothiazide
Tablets
DIOVAN HCT
2/7/2007
9/21/2012
ANDA No. 078020
Vardenafil Hydrochloride Tablets
LEVITRA
9/4/2009
LEVITRA
7/10/2009
LEVITRA
3/5/2009
Vardenafil Hydrochloride
Orally Disintegrating 10 mg Tablets Tablets 0.5 mg and 1 mg
STAXYN
12/22/2011
Varenicline Tartrate
CHANTIX
5/10/2010
Drug
Dosage Form
Strength 10 mg/vial and 20 mg/vial 37.5 mg, 75 mg and 150 mg 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg 37.5 mg, 75 mg and 150 mg 37.5 mg, 75 mg and 150 mg 225 mg
RLD
ANDA Approval Date
Approval Letter
Vecuronium Bromide
For Injection
NORCURON
Venlafaxine Hydrochloride
EFFEXOR XR
Prior to 12/8/2003
6/28/2010
ANDA No. 076565
Venlafaxine Hydrochloride
Tablets
EFFEXOR
11/3/2005
8/3/2006
ANDA No. 076690
Venlafaxine Hydrochloride Venlafaxine Hydrochloride Venlafaxine hydrochloride
Extended-release Tablets Extended-release Tablets Extended-release Tablets Extended-release Capsules Extended-release Capsules Extended-release Tablets Extended-release Tablets
EFFEXOR XR
5/3/2007
VENLAFAXINE HYDROCHLORIDE
2/12/2009
8/18/2010
ANDA No. 091272
Venlafaxine
1/10/2011
Verapamil Hydrochloride
100 mg and 200 mg 120 mg, 180 mg and 240 mg 180 mg
VERELAN PM
7/20/2006 Prior to 12/8/2003 Prior to 12/8/2003 Likely On or After 12/8/2003
VERELAN SR ISOPTIN SR (CALAN SR) COVERA HS
240 mg
300 mg
VERELAN PM
5/19/2006
Drug
Dosage Form
Strength 1 mg/mL, 1 mL, 2 mL and 5 mL vials 200 mg/vial 50 mg and 200 mg
RLD
ANDA Approval Date
Approval Letter
Vincristine Sulfate
Injection
ONCOVIN
Voriconazole
For Injection
VFEND
9/12/2008 ANDA No. 090547
Voriconazole
Tablets
VFEND
4/14/2008
4/22/2010
Voriconazole
Oral Suspension
40 mg/mL
VFEND
10/8/2010
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
Tentative Approval(s) Granted Exclusivity Expected (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Expiration 3/20/2013)
No Exclusivity Granted (New RLD with Approval of NDA No. 22-104 - PIV submitted 2/12/2009) Exclusivity Granted
Exclusivity Relinquished (Pre-MMA)
Tentative Approval(s) Granted Exclusivity Granted

Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker

Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker

Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker

Drug Dosage Form Strength 10 mg and 20 mg 5 mg and 10 mg 100 mg RLD Date of Submission 2/29/2008 ANDA Approval Date 11/15/2010 Approval Letter ANDA No. 090372
Zafirlukast
Tablets
ACCOLATE
Zaleplon
Capsules
SONATA
6/21/2005
Zidovudine
Capsules
RETROVIR ANDA No. 077560
3/2/2012
Ziprasidone Hydrochloride
Capsules
20 mg, 40 mg, 60 mg and 80 mg
GEODON
2/7/2005
3/2/2012
ANDA No. 077561
3/2/2012 0.05 mg/mL, 100 mL vial 0.8 mg (base) /mL 4 mg/100 mg, 100 mL vial 5 mg and 10 mg
ANDA No. 077565
Zoledronic Acid
Injection
RECLAST
8/29/2008
Zoledronic Acid
Injection
ZOMETA
6/11/2008
Zoledronic Acid Zolpidem Tartrate
Injection Sublingual Tablets
ZOMETA EDLUAR
1/31/2012 4/29/2010
Drug
Strength
RLD
Zolpidem Tartrate
6.25 mg
AMBIEN CR
Zolpidem Tartrate
12.5 mg
AMBIEN CR
1/19/2006
12/3/2010
ANDA No. 078148
Zolpidem Tartrate
Sublingual Tablets
1.75 mg and 3.5 mg
INTERMEZZO
4/10/2012
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
Drug
Dosage Form
Strength
RLD
Date of Submission
ANDA Approval Date
Approval Letter
ker
No Exclusivity Granted Exclusivity Granted (Expiration 8/29/2012)
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Forfeited (Application Withdrawn (FDC Act 505(j)(5)(D)(i)(II)) Exclusivity Forfeited (Patent Expiration - FDC Act 505(j)(5)(D)(i)(VI)) FDA Letter Decision
Exclusivity Decision Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act 505(j)(5)(D)(i)(IV)) Exclusivity Granted (Expiration 6/4/2011)

180-Day Exclusivity Tracker

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LAST UPDATED: 3/14/2013

25 mg, 50 mg & 100 mg

1000 mg/100 mL (10 mg/mL)

4/7/2011 Exclusivity Granted (Pre-MMA) (Expiration 11/12/2000)

Prior to 12/8/2003 Prior to 12/8/2003 Prior to 12/8/2003

Acetaminophen/Tramado Tablets l Hydrochloride Acetaminophen/Aspirin/C Tablets affeine

325 mg/37.5 mg 250 mg/250 mg/65 mg

Exclusivity Granted (Pre-MMA) EXCEDRIN (Migraine) 11/26/2001

Strength 6 gm/30 mL (200mg/mL) 50 mg/mL, 10 mL and 20 mL vials 0.30%

Date of Submission After 12/8/2003 Prior to 12/8/2003

ANDA Approval Date 11/7/2012

Approval Letter ANDA No. 200644

Exclusivity Decision Exclusivity Granted (Expiration 5/29/2013)

No Exclusivity Granted (Pre-MMA) ZOVIRAX

Adapalene Adapalene and Benzoyl Peroxide Adefovir Dipivoxil

ANDA No. 200298

10 mg 3 mg/mL, 20 mL and 30 mL vials 2 mg(base)/5 mL 4 mg and 8 mg

Oral Syrup Extended-release Tablets

10/19/2005 Prior to 12/8/2003 Prior to 12/8/2003

Exclusivity Granted (Pre-MMA)

0.09 mg base per actuation

Date of Submission 9/7/2007

ANDA Approval Date

Alendronate Sodium and Tablets Cholecalciferol

70 mg/2800 IU and 70 mg/5600 IU

Exclusivity Granted (Shared) (Expiration 1/14/2012)

Exclusivity Granted (Shared) (Expiration 1/14/2012)

Exclusivity Granted (Shared) (Expiration 1/14/2012)

Exclusivity Granted (Shared) (Expiration 1/14/2012)

Exclusivity Granted (Shared) (Expiration 1/14/2012)

6.25 mg and 12.5 mg

Tentative Approval(s) Granted AXERT 12/8/2005

Drug Alosetron Hydrochloride

Dosage Form Tablets

Strength 0.5 mg and 1 mg

Date of Submission 12/2/2010

ANDA Approval Date

Prior to 12/8/2003 Exclusivity Granted (Expiration 9/23/2008)

2.5 mg, 5 mg and 10 mg

ANDA No. 076418

FDA Letter Decision 1 FDA Letter Decision 2 FDA Letter Decision 3

Amlodipine Besylate and Tablets Atorvastatin Calcium

2.5 mg/10 mg, 2.5 mg/20 mg and 10 mg/40 mg

Amlodipine Besylate and Tablets Atorvastatin Calcium

ANDA Approval Date

Amlodipine Besylate and Tablets Atorvastatin Calcium

Amlodipine Besylate and Tablets Atorvastatin Calcium

4/7/2009 Exclusivity Granted (Expiration 11/14/2007)

Amlodipine Besylate and Capsules Benazepril Hydrochloride

ANDA No. 077179

Amlodipine Besylate and Capsules Benazepril Hydrochloride

Amlodipine Besylate and Tablets Olmesartan Medoxomil

Amlodipine Besylate and Tablets Olmesartan Medoxomil

Amlodipine Besylate and Tablets Valsartan

10/22/2007 Tentative Approval(s) Granted

Amlodipine Besylate and Tablets Valsartan

Date of Submission 10/1/2007

ANDA Approval Date

Exclusivity Decision Tentative Approval(s) Granted

Amlodipine Besylate and Tablets Valsartan

Amlodipine, Hydrochlorothiazide and Valsartan

Amlodipine, Hydrochlorothiazide and Valsartan Amoxicillin and Clavulanate Potassium

40 mg, 80 mg and 125 mg