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USFDA TRACKER FOR EXCLUSIVITY TO ANDAs
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180-Day Exclusivity Tracker
LAST UPDATED: 3/14/2013
Drug Dosage Form Strength RLD Exclusivity Decision
Abacavir Sulfate Tablets 300 mg ZIAGEN 1/28/2009 6/18/2012
Tablets EPZICOM 9/27/2007Tentative Approval(s) Granted
Tablets TRIZIVIR 3/22/2011
Acarbose Tablets PRECOSE 3/22/2005 5/7/2008
Acetaminophen Injection OFIRMEV 4/7/2011
Acetaminophen 650 mg TYLENOL 2/25/2000
Tablets ULTRACET 4/21/2005
Tablets EXCEDRIN (Migraine) 11/26/2001
Exclusivity Granted (Pre-MMA)
Date of Submission
ANDA Approval Date
Approval Letter
ANDA No. 091294Exclusivity Granted (Expiration 12/16/2012)
Abacavir Sulfate/ Lamivudine
600 mg; 300 mg
Abacavir sulfate, Lamivudine and Zidovudine
300 mg/150 mg/300 mg
25 mg, 50 mg & 100 mg
ANDA No. 077532
Exclusivity Forfeited - Failure to Market (FDC Act § 505(j)(5)(D)(i)(I)) FDA Letter Decision
1000 mg/100 mL (10 mg/mL)
Extended-release Tablets
Prior to 12/8/2003
ANDA No. 075077
Exclusivity Granted (Pre-MMA) (Expiration 11/12/2000)
Acetaminophen/Tramadol Hydrochloride
325 mg/37.5 mg
Prior to 12/8/2003
ANDA No. 076475
Exclusivity Granted (Pre-MMA) (Expiration 10/18/2005)
Acetaminophen/Aspirin/Caffeine
250 mg/250 mg/65 mg
Prior to 12/8/2003
ANDA No. 075794
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Acetylcysteine Injection ACETADOTE 11/7/2012
Acyclovir Sodium Injection ZOVIRAX
No Exclusivity Granted (Pre-MMA)
Adapalene Topical Gel 0.30% DIFFERIN 9/15/2009 6/14/2012Exclusivity Granted
Gel 0.1%/2.5% EPIDUO 12/30/2011
Adefovir Dipivoxil Tablets 10 mg HEPSERA 6/8/2010
Adenosine Injection ADENOSCAN 4/16/2005
Albuterol Sulfate Oral Syrup VENTOLIN
Albuterol Sulfate VOLMAX 9/30/2002
Exclusivity Granted (Pre-MMA)
Albuterol Sulfate Inhalation Solution 0.021% ACCUNEB 10/19/2005 9/25/2007Exclusivity Granted
Albuterol Sulfate Inhalation Solution 0.042% ACCUNEB 6/28/2004Exclusivity Granted (Pre-MMA)
Inhalation Solution DUONEB 12/21/2006
Albuterol Sulfate Inhalation Aerosol PRO-AIR HFA 5/18/2012
6 gm/30 mL (200mg/mL)
After 12/8/2003
ANDA No. 200644
Exclusivity Granted (Expiration 5/29/2013)
50 mg/mL, 10 mL and 20 mL vials
Prior to 12/8/2003
ANDA No. 200298
Adapalene and Benzoyl Peroxide
3 mg/mL, 20 mL and 30 mL vials
2 mg(base)/5 mL
Prior to 12/8/2003
Extended-release Tablets
4 mg and 8 mg Prior to
12/8/2003ANDA No. 076130
ANDA No. 077772
Prior to 12/8/2003
ANDA No. 076355
Albuterol Sulfate/ Ipratropium Bromide
0.083%/0.017%
Prior to 12/8/2003
ANDA No. 076867
Exclusivity Granted (Pre-MMA) (Expiration 12/29/2007)
0.09 mg base per actuation
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Alendronate Sodium Oral Solution 70 mg/75 mL FOSAMAX 9/7/2007
Alendronate Sodium Tablets FOSAMAX
2/6/2008
2/6/2008
Tablets FOSAMAX PLUS D 11/20/2007
Alfuzosin Hydrochloride 10 mg UROXATRAL 6/12/2007
7/18/2011
7/18/2011
7/18/2011
7/18/2011
7/18/2011
Almotriptan Malate Tablets AXERT 12/8/2005
Tentative Approval(s) Granted
5 mg, 10 mg, 35 mg, 40 mg and 70 mg
Prior to 12/8/2003
ANDA No. 075710
Exclusivity Granted (Pre-MMA) (Expiration 8/4/2008) (Sole Exclusivity - 5 mg, 10 mg, 35 mg, and 40 mg ; Shared Exclusivity - 70 mg)
ANDA No. 076184
Exclusivity Granted (Pre-MMA); (Expiration 8/4/2008) (Shared Exclusivity on 70 mg strength)
Alendronate Sodium and Cholecalciferol
70 mg/2800 IU and 70 mg/5600 IU
Extended-release Tablets
ANDA No. 079013
Exclusivity Granted (Shared) (Expiration 1/14/2012)
ANDA No. 079014
Exclusivity Granted (Shared) (Expiration 1/14/2012)
ANDA No. 079054
Exclusivity Granted (Shared) (Expiration 1/14/2012)
ANDA No. 079056
Exclusivity Granted (Shared) (Expiration 1/14/2012)
ANDA No. 079057
Exclusivity Granted (Shared) (Expiration 1/14/2012)
6.25 mg and 12.5 mg
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Alosetron Hydrochloride Tablets LOTRONEX 12/2/2010
Alprazolam NIRAVAM 12/27/2005 1/9/2009
Alprazolam Tablets XANAX
Amifostine For Injection 500 mg/vial ETHYOL 4/16/2004 3/14/2008
Amlodipine Besylate Tablets NORVASC 10/3/2005
Tablets CADUET 9/17/2009
Tablets 2.5 mg/40 mg CADUET 9/17/2009
0.5 mg and 1 mg
Orally Disintegrating Tablets
0.25 mg, 0.5 mg, 1 mg and 2 mg
ANDA No. 078088
Exclusivity Granted (Expiration 7/13/2009)
0.25 mg, 0.5 mg, 1 mg and 2 mg
Prior to 12/8/2003
ANDA No. 077126
Exclusivity Granted (Expiration 9/23/2008)
2.5 mg, 5 mg and 10 mg
Prior to 12/8/2003
ANDA No. 076418
Exclusivity Granted (Pre-MMA) (Expiration 3/25/2007; Patent Expiration)
FDA Letter Decision 1
FDA Letter Decision 2
FDA Letter Decision 3
Amlodipine Besylate and Atorvastatin Calcium
2.5 mg/10 mg, 2.5 mg/20 mg and 10 mg/40 mg
Amlodipine Besylate and Atorvastatin Calcium
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets CADUET 12/29/2006
Tablets 5 mg/80 mg CADUET 4/7/2009
Capsules LOTREL 6/9/2004 5/18/2007
Capsules LOTREL 11/17/2006 7/29/2010
Tablets AZOR 2/11/2008
Tentative Approval(s) Granted
Tablets AZOR 3/31/2008
Tentative Approval(s) Granted
Tablets 5 mg/160 mg EXFORGE 10/22/2007
Tentative Approval(s) Granted
Tablets 5 mg/320 mg EXFORGE 11/26/2007
Tentative Approval(s) Granted
Amlodipine Besylate and Atorvastatin Calcium
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
Amlodipine Besylate and Atorvastatin Calcium
Amlodipine Besylate and Benazepril Hydrochloride
2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg
ANDA No. 077179
Exclusivity Granted (Expiration 11/14/2007)
Amlodipine Besylate and Benazepril Hydrochloride
5 mg/40 mg and 10 mg/40 mg
ANDA No. 078381
Exclusivity Granted (Expiration 7/2/2011)
Amlodipine Besylate and Olmesartan Medoxomil
5 mg/20 mg and 10 mg/40 mg
Amlodipine Besylate and Olmesartan Medoxomil
10 mg/20 mg and 5 mg/40 mg
Amlodipine Besylate and Valsartan
Amlodipine Besylate and Valsartan
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets 10 mg/160 mg EXFORGE 10/1/2007
Tentative Approval(s) Granted
Tablets 10 mg/320 mg EXFORGE 11/9/2007
Tentative Approval(s) Granted
Tablets EXFORGE HCT 9/14/2009 9/25/2012
Tablets EXFORGE HCT 10/22/2009 9/25/2012
Exclusivity Granted
AUGMENTIN XR 1/21/2009 4/21/2010
Exclusivity Granted
Aprepitant Capsule EMEND 11/3/2008 9/24/2012
Arformoterol Tartrate Inhalation Solution BROVANA 10/1/2009
Argatroban Injection ARGATROBAN 9/24/2007
Tentative Approval(s) Granted
Injection ARGATROBAN 12/16/2011
Amlodipine Besylate and Valsartan
Amlodipine Besylate and Valsartan
Amlodipine, Hydrochlorothiazide and Valsartan
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
ANDA No. 200435
Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))
Amlodipine, Hydrochlorothiazide and Valsartan
10 mg/12.5 mg/160 mg
ANDA No. 200435
Amoxicillin and Clavulanate Potassium
Extended-release Tablets
1000 mg/62.5 mg
ANDA No. 090227
40 mg, 80 mg and 125 mg
ANDA No. 090999
Eq. 0.015 mg base/2 mL
100 mg/mL, 2.5 mL vials
Argatroban in Sodium Chloride
1 mg/mL, 50 mL vials
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Aripiprazole Oral Solution 1 mg/mL ABILIFY 12/20/2007
Aripiprazole Tablets ABILIFY 11/15/2006
Aripiprazole ABILIFY 11/15/2006
Tentative Approval(s) Granted
Armodafinil Tablets NUVIGIL 7/24/2009 6/1/2012
Exclusivity Granted
Armodafinil Tablets 100 mg NUVIGIL 9/8/2009
Tentative Approval(s) Granted
Armodafinil Tablets 200 mg NUVIGIL 9/3/2009
Tentative Approval(s) Granted
Aspirin and Dipyridamole AGGRENOX 2/1/2007 8/14/2009
Atazanavir Sulfate Capsules REYATAZ 3/19/2010
Tentative Approval(s) Granted
Atazanavir Sulfate Capsules 200 mg REYATAZ 2/16/2010
Tentative Approval(s) Granted
Atazanavir Sulfate Capsules 300 mg REYATAZ 7/20/2009
Tentative Approval(s) Granted
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
Orally Disintegrating Tablets
10 mg, 15 mg, 20 mg and 30 mg
50 mg, 150 mg and 250 mg
ANDA No. 200043
Extended-release Capsules
25 mg and 200 mg
ANDA No. 078804
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
100 mg and 150 mg
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Atenolol Tablets TENORMIN
Atenolol/ Chlorthalidone Tablets TENORETIC
Atovaquone Oral Suspension 750 mg/5 mL MEPRON 10/20/2009
Tablets MALARONE 9/14/2010
Tablets MALARONE 4/3/2009 1/12/2011
Capsules STRATTERA 5/29/2007
8/30/2010
Exclusivity Granted
8/30/2010
Exclusivity Granted
8/30/2010
9/13/2010
Exclusivity Granted
9/16/2010
Exclusivity Granted
25 mg, 50 mg and 100 mg
Prior to 12/8/2003
50 mg/25 mg and 100 mg/25 mg
Prior to 12/8/2003
Atovaquone and Proguanil Hydrochloride
62.5 mg/25 mg
Atovaquone and Proguanil Hydrochloride
250 mg/100 mg
ANDA No. 091211
Exclusivity Granted (Expiration 3/13/2012)
Atomoxetine Hydrochloride
10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
ANDA No. 079020
ANDA No. 079021
ANDA No. 078940
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))
ANDA No. 079016
ANDA No. 079017
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Capsules STRATTERA 5/29/2007
9/13/2010
Exclusivity Granted
10/1/2010
Exclusivity Granted
Atorvastatin Calcium Tablets LIPITOR 11/30/2011
Azelaic Acid Gel 15% FINACEA 7/27/2012
Azelastine Hydrochloride Nasal Spray ASTELIN 11/14/2005 4/30/2009
Azelastine Hydrochloride Nasal Spray ASTEPRO 12/15/2011
Tentative Approval(s) Granted
Azelastine Hydrochloride 0.05% OPTIVAR 12/13/2006 8/3/2009
Azithromycin For Injection 500 mg/vial ZITHROMAX 6/17/2011
Azithromycin 1.00% AZASITE 3/3/2011
Azithromycin Injection ZITHROMAX
3/24/2009
Atomoxetine Hydrochloride
10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
ANDA No. 079018
ANDA No. 079022
10 mg, 20 mg, 40 mg and 80 mg
Prior to 12/8/2003
ANDA No. 076477
Exclusivity Granted (Pre-MMA) (Expiration 5/28/2012)
0.125 mg base/spray
ANDA No. 077954
Exclusivity Granted (Expiration 12/28/2010)
205.5 mcg/spray
Ophthalmic Solution ANDA No.
078621
Exclusivity Granted (Expiration 5/30/2010)
Ophthalmic Solution
500 mg base/vial
On or After 12/8/2003
ANDA No. 065506
Exclusivity Granted (Expiration 11/7/2009)
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
LetterAzithromycin Injection ZITHROMAX
6/26/2009
500 mg base/vial
On or After 12/8/2003
ANDA No. 065500
Exclusivity Granted (Expiration 11/7/2009)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Betamethasone Valerate Foam 0.12% LUXIQ 8/10/2007 11/26/2012
Betaxolol 0.5%(base) BETOPTIC
Bexarotene Capsules 75 mg TARGRETIN 6/6/2011
Bimatoprost 0.01% LUMIGAN 4/5/2011
Bimatoprost 0.03% LUMIGAN 12/22/2008
Bimatoprost Topical Solution 0.03% LATISSE 5/3/2010
Bivalirudin For Injection 250 mg/vial ANGIOMAX 9/1/2009
Bortezomib For Injection 3.5 mg/vial VELCADE 11/20/2008
Brimonidine Tartrate 0.10% ALPHAGAN P 12/20/2006
Brimonidine Tartrate 0.15% ALPHAGAN P 11/3/2006
Brimonidine Tartrate 0.20% ALPHAGAN 5/28/2003
Ophthalmic Solution 0.2%/0.5% COMBIGAN 11/21/2008
Budesonide 3 mg ENTOCORT EC 2/1/2008 5/16/2011
Date of Submission
ANDA Approval Date
Approval Letter
ANDA No. 078337
Ophthalmic Solution Prior to
12/8/2003
Ophthalmic Solution
Ophthalmic Solution
Ophthalmic Solution
Ophthalmic Solution
Ophthalmic Solution Prior to
12/8/2003ANDA No.
076260
Brimonidine Tartrate and Timolol Maleate
Enteric Coated Capsules
ANDA No. 090410
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Budesonide Nasal Spray RHINOCORT 5/14/2007
Budesonide 9/15/2005 11/18/2008
Budesonide 1 mg/2 mL 5/28/2010
174 mg APLENZIN 9/28/2009
348 mg APLENZIN 9/24/2009
522 mg APLENZIN 12/24/2009
WELLBUTRIN SR
12/3/2004
150 mg ZYBAN
WELLBUTRIN XL
9/21/2004 12/14/2006
12/15/2006
0.032 mg (32 mcg)/spray
Inhalation Suspension
0.25 mg/2 mL and 0.5 mg/2 mL
PULMICORT RESPULES
ANDA No. 077519
Inhalation Suspension
PULMICORT RESPULES
Bupropion Hydrobromide Extended-release Tablets
Bupropion Hydrobromide Extended-release Tablets
Bupropion Hydrobromide Extended-release Tablets
Bupropion Hydrochloride Extended-release Tablets
100 mg, 150 mg and 200 mg
Prior to 12/8/2003
ANDA No. 076711
Bupropion Hydrochloride Extended-release Tablets
Prior to 12/8/2003
Bupropion Hydrochloride Extended-release Tablets
150 mg and 300 mg
ANDA No. 077284
On or After 12/8/2003
ANDA No. 077415
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets WELLBUTRIN
Buspirone Hydrochloride Tablets BUSPAR
3/28/2001
3/28/2001
3/28/2001
6/28/2001
Butoconazole Nitrate Vaginal Cream 2% GYNAZOLE-1 12/23/2009 5/18/2012
Butorphanol Tartrate Nasal Spray 10 mg/mL STADOL NS
Bupropion Hydrochloride 75 mg and 100 mg
Prior to 12/8/2003
5 mg, 7.5 mg, 10 mg, 15 mg and 30 mg
Prior to 12/8/2003
ANDA No. 074253
ANDA No. 075272
ANDA No. 075467
ANDA No. 076008
ANDA No. 200923
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Presumably Granted
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 Granted (Pre-MMA) (Expiration 9/16/2003)
Exclusivity Decision
No Exclusivity Granted
Exclusivity Relinquished (Pre-MMA)
Exclusivity Presumably Selectively Waived (Pre-MMA) (100 mg)
Exclusivity Relinquished (Pre-MMA) (150 mg)
See ANDA No. 075932
Exclusivity Granted (Pre-MMA) (200 mg)
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 Decision
No Exclusivity Presumably Granted (Pre-MMA)
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)
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Calcipotriene Topical Cream 0.005% DOVONEX 12/2/2009
Calcipotriene Topical Solution 0.005% DOVONEX 5/19/2006 5/6/2008
Ointment TACLONEX 3/31/2010 1/14/2013
Calcitonin-Salmon Nasal Spray 200 IU/spray MIACALCIN 11/17/2008
Nasal Spray 200 IU/spray FORTICAL 3/29/2006
Calcitriol Injection CALCIJEX
2/20/2003
3/31/2003
12/31/2002
Calcium Acetate Capsules PHOSLO 5/31/2005 2/26/2008
Date of Submission
ANDA Approval Date
Approval Letter
ANDA No. 078305
Calcipotriene and Betamethasone Dipropionate
0.005%/0.064%
ANDA No. 201615
Prior to 12/8/2003
ANDA No. 076396
Calcitonin-Salmon (Recombinant)
1 mcg/mL and 2 mcg/mL, 1 mL vials
Prior to 12/8/2003
ANDA No. 075766
ANDA No. 075823
ANDA No. 075836
EQ 169 mg calcium
ANDA No. 077728
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Chewable Tablets PEPCID COMPLETE 11/1/2004 2/6/2008
Candesartan Cilexetil Tablets ATACAND 12/22/2006
Tablets ATACAND HCT 6/25/2008 12/4/2012
Tablets 32 mg/25 mg ATACAND HCT 3/6/2009 12/4/2012
Capecitabine Tablets XELODA 11/10/2008
Captopril Tablets CAPOTEN
Carbamazepine CARBATROL 2/2/2006
Carbamazepine EQUETRO 8/21/2007
Carbamazepine 300 mg CARBATROL 5/20/2011
Carbamazepine 100 mg TEGRETOL-XR 12/30/2005 3/31/2009
Carbamazepine TEGRETOL-XR
Calcium Carbonate/ Famotidine/ Magnesium Hydroxide
800 mg/ 10 mg/ 165 mg (OTC)
ANDA No. 077355
4 mg, 8 mg, 16 mg and 32 mg
Candesartan Cilexetil and Hydrochlorothiazide
16 mg/12.5 mg and 32 mg/12.5 mg
ANDA No. 090704
Candesartan Cilexetil and Hydrochlorothiazide
ANDA No. 090704
150 mg and 500 mg
12.5 mg, 25 mg, 50 mg, and 100 mg
Prior to 12/8/2003
Extended-release Capsules
100 mg and 200 mg
Extended-release Capsules
200 mg and 300 mg
Extended-release Capsules
Prior to 12/8/2003
ANDA No. 076697
Extended-release Tablets
ANDA No. 078115
Extended-release Tablets
200 mg and 400 mg
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets STALEVO 50 8/5/2008
Tablets 5/19/2009
Tablets 6/29/2007
Tablets STALEVO 200 8/28/2008
Carbidopa/ Levodopa SINEMET CR
Carboplatin For Injection PARAPLATIN
Carboplatin Injection PARAPLATIN
Carisoprodol/ Aspirin Tablets SOMA COMPOUND
Tablets
Carvedilol Tablets COREG
Carvedilol Phosphate COREG CR 3/18/2008
Carbidopa, Levodopa and Entacapone
12.5 mg, 50 mg and 200 mg
Carbidopa, Levodopa and Entacapone
18.75 mg/75 mg/200 mg and 31.25 mg/125 mg/200 mg
STALEVO 75 AND STALEVO 125
Carbidopa, Levodopa and Entacapone
25/100/200 mg and 37.5/150/200 mg
STALEVO 100 AND STALEVO 150
Carbidopa, Levodopa and Entacapone
50 mg/200 mg/200 mg
Extended-release Tablets
25 mg/100 mg and 50 mg/200 mg
Prior to 12/8/2003
50 mg/vial, 150 mg/vial and 450 mg/vial
Prior to 12/8/2003
50 mg/vial, 150 mg/vial and 450 mg/vial
Prior to 12/8/2003
200 mg/ 325 mg
Prior to 12/8/2003
Carisoprodol/ Aspirin/ Codeine
200 mg/ 325 mg/ 16 mg
SOMA COMPOUND WITH CODEINE
Prior to 12/8/2003
3.125 mg, 6.25 mg, 12.5 mg and 25 mg
Prior to 12/8/2003
Extended-release Capsules
10 mg and 20 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Carvedilol Phosphate 40 mg COREG CR 12/21/2007
Carvedilol Phosphate 80 mg COREG CR 11/19/2007
Caspofungin Acetate For Injection CANCIDAS 6/26/2009
Celecoxib Capsules 50 mg CELEBREX 3/21/2008
Celecoxib Capsules CELEBREX
Cetirizine Hydrochloride Syrup 5 mg/5 mL ZYRTEC 3/19/2007
Cetirizine Hydrochloride Chewable Tablets ZYRTEC 3/25/2005 1/11/2008
5 mg/120 mg ZYRTEC-D 6/2/2004 2/25/2008
Capsules 30 mg EVOXAC 2/27/2009 8/25/2011
Chlorhexidine Gluconate 4% HIBICLENS
TUSSIONEX 9/10/2004
Ciclesonide Nasal Spray 250 mcg OMNARIS 2/13/2012
Extended-release Capsules
Extended-release Capsules
50 mg/vial and 70 mg/vial
100 mg, 200 mg and 400 mg
Likely Pre-MMA
5 mg and 10 mg (OTC)
ANDA No. 077631
Cetirizine Hydrochloride and Pseudoephedrine
Extended-release Tablets
ANDA No. 077170
Cevimeline Hydrochloride
ANDA No. 091260
Scrub brush/sponge
Prior to 12/8/2003
Chlorpheniramine Polistirex and Hydrocodone Polistirex
Extended-release Capsules
8 mg/10 mg and 4 mg/5 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Ciclopirox Gel 0.77% LOPROX 5/10/2006 1/7/2009
Tablets SENSIPAR 3/10/2008
Ciprofloxacin Oral Suspension CIPRO 10/16/2009
Tablets CIPRO 6/9/2004
500 mg CIPRO XR 11/30/2010
1000 mg CIPRO XR 11/30/2010
Cisatracurium Besylate NIMBEX 8/12/2009
Cisatracurium Besylate NIMBEX 8/4/2009
Cisplatin Injection PLATINOL-AQ 7/16/1999
Cisplatin For Injection PLATINOL
ANDA No. 078266
Cinacalcet Hydrochloride 30 mg, 60 mg and 90 mg
250 mg/5 mL and 500 mg/ 5 mL
Ciprofloxacin Hydrochloride
100 mg, 250 mg, 500 mg and 750 mg
Prior to 12/8/2003
ANDA No. 075593
Ciprofloxacin Hydrochloride
Extended-release Tablets
On or After 12/8/2003
ANDA No. 077417
Ciprofloxacin Hydrochloride
Extended-release Tablets
On or After 12/8/2003
ANDA No. 077809
(multi-dose) Injection
2 mg/mL, 10 mL vial
(preserve free) Injection
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
Prior to 12/8/2003
ANDA No. 074735
10 mg/vial and 50 mg/vial
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Clarithromycin 500 mg BIAXIN XL 12/6/2010
Clindamycin Phosphate Foam 1% EVOCLIN 3/31/2010
Gel 1% / 5% DUAC 12/11/2008
Gel 1.2%/0.025% ZIANA 12/17/2010 6/26/2012
Clobetasol Propionate 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
Clobetasol Propionate Lotion 0.05% CLOBEX 3/27/2006 12/4/2008
Clobetasol Propionate Spray 0.05% CLOBEX 9/29/2008 6/16/2011
Clobetasol Propionate Topical Shampoo 0.05% CLOBEX 1/9/2008 6/7/2011
Clofarabine Injection CLOLAR 2/23/2012
Clonidine hydrochloride KAPVAY 3/4/2011
Clonidine hydrochloride JENLOGA 3/4/2011
Extended-release Tablet
PIV received prior to
2/5/2009ANDA No. 090785
Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Tretinoin
ANDA No. 090979
ANDA No. 201402
ANDA No. 077763
ANDA No. 078223
ANDA No. 090898
ANDA No. 078854
1 mg/mL, 20 mL vial
Extended-release Tablets
0.1 mg and 0.2 mg
Extended-release Tablets
0.1 mg and 0.2 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Clonidine Hydrochloride CATAPRES-TTS
Clopidogrel Bisulfate Tablets 75 mg PLAVIX
5/17/2012
Clopidogrel Bisulfate Tablets 300 mg PLAVIX 3/4/2009 5/17/2012
Clozapine 12.5 mg FAZACLO 6/5/2008
Clozapine FAZACLO 4/28/2008
Clozapine 150 mg FAZACLO 4/8/2011
Clozapine 200 mg FAZACLO 4/18/2011
Colchicine Tablets 0.6 mg COLCRYS 12/23/2011
WELCHOL 4/9/2010
Transdermal System
0.1 mg/day, 0.2 mg/day, and 0.3 mg/day
Prior to 12/8/2003
Prior to 12/8/2003
1/20/2006 (6/22/2009 -
Converted to a Tentative Approval)
ANDA No. 076274
ANDA No. 077665
ANDA No. 091023
Orally Disintegrating Tablets
Orally Disintegrating Tablets
25 mg and 100 mg
Orally Disintegrating Tablets
Orally Disintegrating Tablets
Colesevelam Hydrochloride
Powder for Oral Suspension
1.875 g/Packet and 3.75 g/Packet
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets 625 mg WELCHOL 7/1/2009
Colestipol Hydrochloride Tablets 1 g COLESTID 8/23/2005 10/24/2006
Tablets CENESTIN 3/19/2009
Tablets 1.25 mg CENESTIN 11/3/2008
Tablets 0.625 mg CENESTIN 3/2/2009
Conjugated Estrogens Tablets PREMARIN
Tablets 10 mg FLEXERIL 2/29/1988
AMRIX 8/11/2008 4/18/2011
Cyclophosphamide For Injection CYTOXAN
Colesevelam Hydrochloride
ANDA No. 077510
Conjugated Estrogen (Synthetic A)
0.3 mg, 0.45 mg and 0.9 mg
Conjugated Estrogen (Synthetic A)
Conjugated Estrogen (Synthetic A)
0.3 mg and 0.625 mg
Prior to 12/8/2003
Cyclobenzaprine Hydrochloride
Prior to 12/8/2003
ANDA No. 071611
Cyclobenzaprine Hydrochloride
Extended-release Capsule
15 mg and 30 mg
ANDA No. 090738
100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial and 2 g/vial
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted
Exclusivity Granted (Expiration 11/2/2008)
Exclusivity Granted (Expiration 6/7/2009)
Exclusivity Granted (Pre-MMA; Shared) (Expiration 9/17/2003)
Exclusivity Granted (Pre-MMA; Shared) (Expiration 9/17/2003)
Exclusivity Granted (Pre-MMA; Shared) (Expiration 9/17/2003)
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Granted
Exclusivity Forfeited
Presumably 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))
Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
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))
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
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)
Exclusivity Decision
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 (Expiration 4/6/2013)
Exclusivity Decision
Exclusivity Granted
Tentative Approval(s) Granted
Exclusivity Granted
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 - (Expiration 5/15/2000)
FDA Decision - Docket No. FDA-1999-P-0058 (formerly Docket No. 1999P-1271) (Aug. 2, 1999))
Exclusivity Decision
Exclusivity Granted
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 (Expiration 6/30/2012)
Exclusivity Granted (Expiration 6/30/2012) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))
Exclusivity Decision
No Exclusivity Presumably Granted
Exclusivity Granted (Pre-MMA) (Expiration 2/4/2007)
Exclusivity Granted (Pre-MMA) (Expiration 11/13/2012)
Exclusivity Granted (Expiration 11/13/2012)
Exclusivity Decision
Exclusivity Granted (Expiration 6/12/2007)
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))
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD Exclusivity Decision
Daptomycin For Injection 500 mg/vial CUBICIN 11/19/2008
ENABLEX 12/22/2008Tentative Approval(s) Granted
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 99.90% SUPRANE 9/11/2008
Desloratadine Tablets 5 mg CLARINEX 6/21/2006
Desloratadine CLARINEX 6/21/2006
Date of Submission
ANDA Approval Date
Approval Letter
Darifenacin Hydrobromide
Extended-release Tablets
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
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
Orally Disintegrating Tablets
2.5 mg and 5 mg
Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
See ANDA No. 078367
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Desloratadine Oral Solution 0.5 mg/mL CLARINEX SYRUP 5/8/2008
6/1/2007
5 mg/240 mg 6/21/2006
Desmopressin Acetate Injection DDAVP
Desmopressin Acetate Nasal Spray 0.01% DDAVPNo Exclusivity Granted (Pre-MMA)
Desmopressin Acetate Tablets DDAVP 7/1/2005
Tablets MIRCETTE 4/5/2002
Desonide Gel 0.05% DESONATE 12/1/2010
PRISTIQ 2/29/2012
Dexlansoprazole 30 mg DEXILANT 11/30/2010
Desloratadine and Pseudoephedrine Sulfate
Extended-release Tablets
2.5 mg/120 mg CLARINEX-D 24
HOUR
Desloratadine and Pseudoephedrine Sulfate
Extended-release Tablets
CLARINEX-D 24 HOUR
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
4 mcg/mL, 1 mL and 10 mL vials
Prior to 12/8/2003
Prior to 12/8/2003
0.1 mg and 0.2 mg
Prior to 12/8/2003
ANDA No. 076470
Exclusivity Granted (Pre-MMA) (Expiration 12/28/2005)
Desogestrel; Ethinyl Estradiol
0.15mg/ 0.02 mg and 0.01 mg
Prior to 12/8/2003
ANDA No. 075863
Exclusivity Granted (Pre-MMA) (Expiration 6/4/2002)
Desvenlafaxine Succinate
Extended-release Tablets
50 mg and 100 mg
Delayed-release Capsule
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Dexlansoprazole 60 mg DEXILANT 8/25/2010
Dexmedetomidine Injection 100 mcg/mL PRECEDEX 4/8/2009Tentative Approval(s) Granted
Tablets 2.5 mg FOCALIN 7/27/2004 1/29/2007
Tablets FOCALIN 5/27/2004 1/29/2007
15 mg FOCALIN XR 5/14/2007
FOCALIN XR 3/30/2007
30 mg FOCALIN XR 12/15/2010Tentative Approval(s) Granted
40 mg FOCALIN XR 12/20/2010
Dexmethylphenidate 25 mg FOCALIN XR 9/30/2011
Dexmethylphenidate 35 mg FOCALIN XR 9/29/2011
Dexrazoxane For Injection ZINECARD 9/28/2004
ADDERALL XR
8/25/2004
Delayed-release Capsule
Dexmethylphenidate Hydrochloride
ANDA No. 077107
Exclusivity Granted (Expiration 12/3/2007)
Dexmethylphenidate Hydrochloride
5 mg and 10 mg
ANDA No. 077107
Exclusivity Granted (Expiration 12/3/2007)
Dexmethylphenidate Hydrochloride
Extended-release Capsules
Dexmethylphenidate Hydrochloride
Extended-release Capsules
5 mg, 10 mg and 20 mg
Dexmethylphenidate Hydrochloride
Extended-release Capsule
Dexmethyphenidate Hydrochloride
Extended-release Capsule
Extended-release capsules
Extended-release capsules
250 mg/vial, and 500 mg/vial
Prior to 12/8/2003
ANDA No. 076068
Exclusivity Granted (Pre-MMA) (Expiration 8/27/2005; 250 mg/vial) (Expiration 10/19/2005; 500 mg/vial)
Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate
Extended-release Capsules
5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg
Prior to 12/8/2003
ANDA No. 076814
Exclusivity Granted (Expiration 8/4/2008; 5 mg)
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
LetterADDERALL XR
Tablets ADDERALL 30 11/18/2009
Tablets ADDERALL 2/11/2002
30 mg/5 mL DELSYM 1/12/2009 5/25/2012Exclusivity Granted
Capsules 20 mg/10 mg NUEDEXTA 3/7/2011
Diazepam Tablets VALIUM
Diazepam Rectal Gel DIASTAT 3/23/2004
Diazepam Rectal Gel DIASTAT ACUDIAL 12/8/2008
Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate
Extended-release Capsules
5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg
Prior to 12/8/2003
A period of 180-day exclusivity was triggered by the launch of an authorized generic.
Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate
5 mg, 10 mg, 20 mg, 30 mg
Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate
7.5 mg, 12.5 mg and 15 mg
Prior to 12/8/2003
ANDA No. 040422
Exclusivity Granted (Pre-MMA) (Expiration 9/15/2003)
Dextromethorphan Polistirex
Extended-release Suspension
ANDA No. 091135
Dextromethorphan Hydrobromide and Quinidine Sulfate
2 mg, 5 mg and 10 mg
Prior to 12/8/2003
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
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Diazepam Rectal Gel DIASTAT ACUDIAL 12/23/2008
Diclofenac Potassium 50 mg CAMBIA 1/24/2011
Diclofenac Sodium Topical Gel 3% SOLARAZE 12/16/2009
Diclofenac Sodium Topical Solution 2% PENNSAID 7/11/2012
50 mg/0.2 mg ARTHROTEC 6/29/2009
75 mg/0.2 mg ARTHROTEC 11/28/2008
Didanosine VIDEX EC 6/1/2004 12/3/2004
Diltiazem Hydrochloride CARDIZEM SR
Diltiazem Hydrochloride DILACOR XR
Diltiazem Hydrochloride CARDIZEM CD 7/9/1998
Diltiazem Hydrochloride TIAZAC
4/10/2003
5 mg/mL, 2mL pre-filled syringe
Oral Solution (Sachet)
Diclofenac Sodium and Misoprostol
Delayed-release Tablets
Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
Diclofenac Sodium and Misoprostol
Delayed-release Tablets
Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
Delayed-release Capsules
200 mg, 250 mg and 400 mg
ANDA No. 077167
Exclusivity Granted (Expiration 6/16/2005)
Extended-release Capsules
60 mg, 90 mg and 120 mg
Prior to 12/8/2003
Extended-release Capsules
120 mg, 180 mg and 240 mg
Prior to 12/8/2003
Extended-release Capsules
120 mg, 180 mg, 240 mg and 300 mg
Prior to 12/8/2003
ANDA No. 074752
Exclusivity Granted (Pre-MMA) (Expiration 12/20/1999)
Extended-release Capsules
120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg
Prior to 12/8/2003
ANDA No. 075401
Exclusivity Granted (Pre-MMA) (Sole exclusivity on 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg)
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
LetterDiltiazem Hydrochloride TIAZAC
9/12/2006
Diltiazem Hydrochloride CARDIZEM LA 8/30/2005 3/15/2010
Exclusivity Granted
Diltiazem Hydrochloride 420 mg CARDIZEM LA 4/25/2005 3/15/2010Exclusivity Granted
Divalproex Sodium DEPAKOTE
No Exclusivity Granted
Divalproex Sodium 250 mg DEPAKOTE ER 5/3/2004
Divalproex Sodium 500 mg DEPAKOTE ER 2/8/2005 1/29/2009
Docetaxel Injection TAXOTERE 6/30/2009
Donepezil Hydrochloride Tablets ARICEPT 11/26/2010
Donepezil Hydrochloride ARICEPT ODT 6/30/2010 11/25/2010
Doripenem Injection DORIBAX 10/12/2011
Extended-release Capsules
120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg
Prior to 12/8/2003
ANDA No. 076563
Exclusivity Granted (Pre-MMA) (Sole exclusivity the 420 mg)
Extended-release Tablets
120 mg, 180 mg, 240 mg, 300 mg and 360 mg
ANDA No. 077686
Extended-release Tablets
ANDA No. 077686
Delayed-release Tablets
125 mg, 250 mg and 500 mg
Prior to 12/8/2003
Extended-release Tablets
ANDA No. 077143
Exclusivity Forfeited (Application Withdrawn (FDC Act § 505(j)(5)(D)(i)(II))
Extended-release Tablets
ANDA No. 077567
Exclusivity Granted (Expiration 8/1/2009)
40 mg/mL, 0.5 mL and 2 mL vials
5 mg and 10 mg
Prior to 12/8/2003
ANDA No. 076786
Exclusivity Granted (Pre-MMA) (Expiration 5/28/2011) (Originally Shared Exclusivity; later FDA determination that no shared exclusivity for non-mutually blocking Paragraph IV Certifications)
FDA Letter Decision
Orally Disintegrating Tablets
5 mg and 10 mg
ANDA No. 078388
Exclusivity Granted, Then Revoked - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
250 mg/vial and 500 mg/vial
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
2% TRUSOPT 10/11/2005No Exclusivity Granted
2%/0.5% COSOPT 10/11/2005 10/28/2008
Doxazosin Mesylate Tablets CARDURANo Exclusivity Granted (Pre-MMA)
Doxepin Hydrochloride Tablets SILENOR 9/16/2010Tentative Approval(s) Granted
Doxercalciferol Capsules 1 mcg HECTOROL 2/12/2010Tentative Approval(s) Granted
Doxercalciferol Capsules HECTOROL 3/25/2009 9/23/2011
Doxercalciferol Injection HECTOROL 10/15/2007
Doxercalciferol Injection HECTOROL 12/28/2011
Doxycycline 40 mg ORACEA 12/11/2008 7/1/2010
Exclusivity Granted (QI Act)
Doxycycline Hyclate DORYX
12/28/2010
12/28/2010
Dorzolamide Hydrochloride
Ophthalmic Solution
Dorzolamide Hydrochloride and Timolol Maleate
Ophthalmic Solution ANDA No. 077847
Exclusivity Forfeited - Failure to Market (FDC Act § 505(j)(5)(D)(i)(I))
FDA Letter Decision
1 mg, 2 mg, 4 mg, and 8 mg
Prior to 12/8/2003
3 mg and 6 mg
0.5 mcg and 2.5 mcg
ANDA No. 091433Exclusivity Granted (0.5 mcg); Tentative Approval(s) Granted (2.5 mcg)
2 mcg/mL, 2 mL ampules
ANDA No. 090040
Tentative Approval(s) Granted; Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))
FDA Citizen Petition Decision
2 mcg/mL, 1 mL in 2 mL vial
Delayed-release Capsules
ANDA No. 090855
Delayed-release Tablets
75 mg and 100 mg
PIV received prior to
2/5/2009
ANDA No. 090431
Exclusivity Granted (QI Act; Shared) (Expiration 6/28/2011) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV) & Citizen Petition exception)
ANDA No. 090505
Exclusivity Granted (QI Act; Shared) (Expiration 6/28/2011) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV) & Citizen Petition exception)
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
Doxycycline Hyclate 150 mg DORYX 12/19/2008
Tablets 0.5 mg/1 mg ANGELIQ 12/26/2007
Tablets 3 mg/0.02 mg YAZ 9/29/2006 3/30/2009
Exclusivity Granted
Tablets 3 mg/0.03 mg YASMIN 1/7/2005 5/9/2008
Tablets BEYAZ 11/21/2011
CYMBALTA 8/4/2008
Tentative Approval(s) Granted
40 mg CYMBALTA 5/10/2012
Dutasteride Capsules 0.5 mg AVODART 10/29/2007 12/21/2010
Capsule 0.5 mg/0.4 mg JALYN 10/26/2010
Delayed-release Tablets
Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
See ANDA No. 091052
Drospirenone and Estradiol
Drospirenone and Ethinyl Estradiol
ANDA No. 078515
Drospirenone and Ethinyl Estradiol
ANDA No. 077527
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV)); FDA later determined that 180-day exclusivity was forfeited (FDC Act § 505(j)(5)(D)(i)(IV)) and approved ANDA No. 090081.
Drospirenone and Ethinyl Estradiol and Levomefolate
3 mg/0.02 mg/0.451 mg and 0.451 mg
Duloxetine Hydrochloride
Delayed-release Capsules
20 mg, 30 mg and 60 mg
Duloxetine Hydrochloride Delayed-release Capsules
ANDA No. 090095
Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
Dutasteride and Tamsulosin Hydrochloride
Drug Dosage Form Strength RLD Exclusivity DecisionDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Efavirenz Tablets 600 mg SUSTIVA 4/9/2009
Tablets ATRIPLA 12/29/2008
Eletriptan Hydrobromide Tablets RELPAX 3/29/2010
Tablets TRUVADA 9/26/2008
Enalapril Maleate Tablets VASOTEC
Enoxaparin Sodium Injection LOVENOX
Enoxaparin Sodium Injection LOVENOX
Enoxaparin Sodium Injection LOVENOX 12/7/2006
Date of Submission
ANDA Approval Date
Approval Letter
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
600 mg/200 mg/300 mg
20 mg and 40 mg
Emtricitabine and Tenofovir Disoproxil Fumarate
200 mg/300 mg
2.5 mg, 5 mg, 10 mg and 20 mg
Prior to 12/8/2003
100 mg/mL, 0.3 mL, 0.4 mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes
Prior to 12/8/2003
150 mg/mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes
Prior to 12/8/2003
100 mg/mL, 3 mL vials
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Entacapone Tablets 200 mg COMTAN 4/11/2007
Entecavir Tablets BARACLUDE 6/14/2010
Epinastine Hydrochloride 0.05% ELESTAT 10/14/2008 3/14/2011
Epinephrine 7/20/2009
Eplerenone Tablets INSPRA 9/27/2006
7/30/2008
8/1/2008
Eprosartan Mesylate Tablets TEVETEN 5/10/2010 11/16/2011
Eptifibatide Injection INTEGRILIN 6/5/2009
Eptifibatide Injection INTEGRILIN 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
0.5 mg and 1 mg
Ophthalmic Solution ANDA No. 090870
Injection (Autoinjector)
0.15 mg/0.3 mL and 0.3 mg/0.3 mL
EPIPEN AND EPIPEN JR.
25 mg and 50 mg
ANDA No. 078482
ANDA No. 078510
400 mg and 600 mg
ANDA No. 202012
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
ANDA No. 077660
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Escitalopram Oxalate Capsules LEXAPRO 3/30/2005 7/31/2007
Escitalopram Oxalate Tablets LEXAPRO 3/14/2012
Esmolol Hydrochloride Injection BREVIBLOC 8/10/2004
NEXIUM 8/5/2005
Esomeprazole Sodium For Injection NEXIUM IV 11/23/2009
Estradiol VIVELLE DOT 4/27/2010
Estradiol CLIMARA 9/12/2005 7/20/2006
Estradiol CLIMARA 2/24/2000
Tablets PREFEST 4/29/2005
Tablets NATAZIA 10/22/2010
10 mg and 20 mg
ANDA No. 077660
5 mg, 10 mg and 20 mg
Prior to 12/8/2003
ANDA No. 076765
10 mg/mL, 10 mL vial
Prior to 12/8/2003
ANDA No. 076323
Esomeprazole Magnesium
Delayed-release Capsules
20 mg and 40 mg
20 mg/vial and 40 mg/vial
Transdermal System
0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day
Transdermal System
0.0375 mg/day and 0.06 mg/day
ANDA No. 075182
Transdermal System
0.05 mg/day and 0.1 mg/day
Prior to 12/8/2003
ANDA No. 075182
Estradiol; Estradiol and Norgestimate
1 mg; 1 mg and 0.09 mg
Prior to 12/8/2003
ANDA No. 076812
Estradiol Valerate and Dienogest
3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Eszopiclone Tablets LUNESTA 12/15/2008 5/21/2011
Etodolac LODINE XL
7/31/2000
7/31/2000
Ezetimibe Tablets 10 mg ZETIA 10/25/2006
Tablets VYTORIN 7/27/2009
1 mg, 2 mg and 3 mg
ANDA No. 091169
Extended-release Tablets
400 mg, 500 mg and 600 mg
Prior to 12/8/2003
ANDA No. 075665
ANDA No. 075696
Ezetimibe and Simvastatin
10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
No Exclusivity Granted (Pre-MMA)
Exclusivity Expired (Court Decision; Pre-MMA)
Exclusivity Expired (Court Decision; Pre-MMA)
See ANDA No. 077857
See ANDA No. 077857
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Granted (Expiration 10/29/2011)
Exclusivity Granted (Shared) (Expiration 1/26/2009)
Exclusivity Granted (Shared) (Expiration 1/26/2009)
Exclusivity Granted (Expiration 6/17/2012)
Exclusivity Granted (Suitability Petition - Docket No. 2004P-0247)
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
Exclusivity Presumably Granted (Pre-MMA)
Exclusivity Granted (Suitability Petition - Docket No. 2004P-0247)
Exclusivity Granted (Pre-MMA) (Expiration 9/10/2012)
Exclusivity Granted (Pre-MMA) (Expiration 5/1/2005)
Exclusivity Granted (Expiration 2/6/2007)
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Sole Exclusivity on 500 mg & 600 mg; Expiration 2/13/2001)
Exclusivity Granted (Pre-MMA) (Sole Exclusivity on 400 mg strength; Expiration 2/4/2001)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Famciclovir Tablets FAMVIR 12/28/2004 8/24/2007
Famotidine Injection PEPCID
Famotidine Injection PEPCID
Famotidine Injection PEPCID
Famotidine Tablets 10 mg (OTC) PEPCID AC
5/31/2001
11/28/2001
Famotidine Tablets PEPCID
Famotidine 10 mg (OTC) 8/22/2003
Date of Submission
ANDA Approval Date
Approval Letter
125 mg, 250 mg and 500 mg
ANDA No. 077487
10 mg/mL, 2 mL vials; unpreserved
Prior to 12/8/2003
10 mg/mL, 4 mL and 20 mL vials; preserved
Prior to 12/8/2003
10 mg/mL, 50 mL vial, pharmacy bulk package; unpreserved
Prior to 12/8/2003
Prior to 12/8/2003
ANDA No. 075312
ANDA No. 075404
20 mg and 40 mg
Prior to 12/8/2003
Tablets (Chewable) PEPCID AC
(CHEWABLE)Prior to
12/8/2003ANDA No.
075715
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Felodipine PLENDIL ER 11/2/2004
Fenofibrate Tablets FENOGLIDE 3/17/2010
Fenofibrate Capsules ANTARA 9/15/2008 3/1/2012
Fenofibrate Choline 45 mg TRILIPIX 9/2/2009
Fenofibrate Choline 135 mg TRILIPIX 9/1/2009
Fenofibrate Capsules TRICOR 4/9/2002
Fenofibrate Tablets 48 mg TRICOR 7/1/2008
Fenofibrate Tablets TRICOR
5/13/2005
10/31/2005
12/29/2005
Fenofibrate Tablets 145 mg TRICOR 10/19/2007
Extended-release Tablets
2.5 mg, 5 mg and 10 mg
Prior to 12/8/2003
ANDA No. 075896
40 mg and 120 mg
43 mg and 130 mg
ANDA No. 090859
Delayed-release Capsules
Delayed-release Capsules
67 mg, 134 mg and 200 mg
Prior to 12/8/2003
ANDA No. 075753
54 mg, 107 mg and 160 mg
Prior to 12/8/2003
ANDA No. 076433
ANDA No. 076635
ANDA No. 076520
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Fentanyl DURAGESIC
Fentanyl Citrate Buccal Tablets FENTORA 11/13/2007 1/7/2011
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 Lozenges ACTIQ 11/22/2004
Oral Suspension 30 mg/5 mL ALLEGRA 1/25/2010 7/25/2012
Capsules 60 mg ALLEGRA 7/13/2005
Tablets ALLEGRA
8/31/2005
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
Prior to 12/8/2003
11/21/2003 (6/22/2004 - Converted to a Tentative Approval)
ANDA No. 076258
(1/28/2005 - Converted Back to a Final Approval)
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg
ANDA No. 079075
0.8 mg, 1.2 mg and 1.6 mg
Fexofenadine Hydrochloride
ANDA No. 201311
Fexofenadine Hydrochloride
Prior to 12/8/2003
ANDA No. 076169
Fexofenadine Hydrochloride
30 mg, 60 mg and 180 mg
Prior to 12/8/2003
ANDA No. 076191
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
LetterTablets ALLEGRA
4/16/2007
60 mg/120 mg ALLEGRA-D
4/14/2005
11/12/2010
6/6/2007 3/16/2010
Finasteride Tablets 1 mg PROPECIA 7/28/2006
Finasteride Tablets 5 mg PROSCAR 6/19/2006
Flecainide Acetate Tablets TAMBOCOR 7/31/2001
Fluconazole
Fluconazole Tablets DIFLUCAN
Flunisolide Nasal Solution 0.025% NASALIDE
Fluocinonide Cream 0.10% VANOS 1/31/2008
Fexofenadine Hydrochloride
30 mg, 60 mg and 180 mg
Prior to 12/8/2003
ANDA No. 077081
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-release Tablets
Prior to 12/8/2003
ANDA No. 076236
ANDA No. 076298
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-release Tablets
180 mg/240 mg
ALLEGRA-D 24 HOUR
ANDA No. 079043
Prior to 12/8/2003
ANDA No. 076436
Prior to 12/8/2003
ANDA No. 076340
50 mg, 100 mg and 150 mg
Prior to 12/8/2003
ANDA No. 075442
For Oral Suspension 50 mg/5 mL and 200 mg/5 mL
DIFLUCAN FOR ORAL SUSPENSION
Prior to 12/8/2003
50 mg, 100 mg, 150 mg and 200 mg
Prior to 12/8/2003
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Fluocinonide Ointment 0.05% LIDEX
Fluorouracil Cream 0.50% CARAC 7/29/2011
Fluoxetine Hydrochloride Tablets PROZAC 8/2/2001
Fluoxetine Hydrochloride Capsules PROZAC
8/2/2001
8/2/2001
8/2/2001
Fluoxetine Hydrochloride 90 mg PROZAC WEEKLY 3/24/2010
Fluoxetine Hydrochloride Oral Solution PROZAC 8/2/2001
Fluoxetine Hydrochloride Capsules SARAFEM 5/20/2008
Flutamide Capsules 125 mg EULEXIN
Prior to 12/8/2003
10 mg and 20 mg
Prior to 12/8/2003
ANDA No. 075755
10 mg, 20 mg and 40 mg
Prior to 12/8/2003
ANDA No. 075049
ANDA No. 074803
ANDA No. 075465
Delayed-release Capsules
Prior to 12/8/2003
ANDA No. 076237
20 mg (base)/5 mL
Prior to 12/8/2003
ANDA No. 075506
10 mg and 20 mg
Prior to 12/8/2003
ANDA No. 076287
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Fluticasone Furoate Nasal Spray 27.5 mcg Veramyst 7/15/2011
Fluticasone Propionate Lotion 0.05% CUTIVATE 7/28/2008 5/2/2011
Fluvastatin Capsules LESCOL 6/4/2008
Fluvastatin Sodium 80 mg LESCOL XL 3/15/2007
Fulvestrant Injection FASLODEX 10/1/2009
Fluvoxamine Maleate 100 mg LUVOX CR 4/20/2009
Fluvoxamine Maleate 150 mg LUVOX CR 4/13/2009
Formoterol Fumarate Inhalation Solution 0.02 mg/2 mL PERFOROMIST 1/21/2009
Fosamprenavir calcium Tablets 700 mg LEXIVA 1/18/2012
Injection 115 mg/vial EMEND 1/25/2012
Injection 150 mg/vial EMEND 1/25/2012
Fosinopril Sodium Tablets MONOPRIL 11/25/2003
Tablets MONOPRIL HCT 12/3/2004
Frovatriptan Succinate Tablets 2.5 mg FROVA 3/9/2011
ANDA No. 090759
20 mg and 40 mg
Extended-release Tablets
50 mg/mL, 2.5 mL and 5 mL syringe
Extended-release Capsules
Extended-release Capsules
Fosaprepitant dimeglumine
Fosaprepitant dimeglumine
10 mg, 20 mg and 40 mg
Prior to 12/8/2003
ANDA No. 076139
Fosinopril Sodium and Hydrochlorothiazide
10 mg/12.5 mg and 20 mg/12.5 mg
Prior to 12/8/2003
ANDA No. 076608
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
Exclusivity Granted (Expiration 3/3/2008)
Exclusivity Granted (Pre-MMA) (Expiration 11/28/2001)
Exclusivity Granted (Pre-MMA) (Second period granted)
Exclusivity Granted (Pre-MMA)
Exclusivity Decision
Exclusivity Granted (Pre-MMA) (Expiration 4/27/2005)
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)
No Exclusivity Granted (Likely Forfeiture)
No Exclusivity Granted (Likely Forfeiture)
No Exclusivity Granted (Likely Forfeiture)
No Exclusivity Granted (Likely Forfeiture)
Exclusivity Granted
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))
Exclusivity Granted (Pre-MMA) (30 mg, 60 mg, and 180 mg)
Selectively Waived - See ANDA No. 76-447
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA) (Expiration 10/21/2008; 30 mg & 60 mg) (Second Period)
Exclusivity Granted (Pre-MMA) (Expiration 5/2/2010)
Exclusivity Granted (Pre-MMA) (Second Period)
Exclusivity Granted (Expiration 7/27/2011)
Exclusivity Granted (Pre-MMA) (Expiration 7/1/2013)
Exclusivity Granted (Pre-MMA) (Expiration 12/16/2006)
Exclusivity Granted (Pre-MMA) (Expiration 10/28/2002)
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
Exclusivity Granted (Pre-MMA) (Expiration 1/29/2002)
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 (Pre-MMA) (Expiration 11/17/2008)
Exclusivity Decision
Exclusivity Granted
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA) (Expiration 4/23/2004)
Exclusivity Granted (Pre-MMA) (Expiration 1/1/2005)
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Gabapentin Capsules NEURONTIN 9/12/2003
Gabapentin Oral Solution 250 mg/5 mL NEURONTIN 2/18/2011
Gabapentin Tablets GRALISE 10/31/2011
Gabapentin Tablets NEURONTIN 4/28/2004
Gabapentin Tablets NEURONTIN 10/21/2004
8 mg RAZADYNE ER 3/2/2006 9/15/2008
RAZADYNE ER 3/11/2006 9/15/2008
Tablets RAZADYNE 2/28/2005
9/11/2008
8/28/2008
Date of Submission
ANDA Approval Date
Approval Letter
100 mg, 300 mg and 400 mg
Prior to 12/8/2003
ANDA No. 075350
Prior to 12/8/2003
ANDA No. 078974
300 mg and 600 mg
100 mg, 300 mg and 400 mg
Prior to 12/8/2003
ANDA No. 076017
600 mg and 800 mg
Prior to 12/8/2003
ANDA No. 075694
Galantamine Hydrobromide
Extended-release Capsules
ANDA No. 078189
Galantamine Hydrobromide
Extended-release Capsules
16 mg and 24 mg
ANDA No. 078189
Galantamine Hydrobromide
4 mg, 8 mg and 12 mg
ANDA No. 077593
ANDA No. 077603
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets RAZADYNE 2/28/2005 8/28/2008
2/6/2009
2/11/2009
Ganciclovir Sodium Capsules CYTOVENE 6/27/2003
Ganirelix Acetate Injection 3/30/2012
Gatifloxacin Injection TEQUIN 11/24/2004
Gatifloxacin 0.30% ZYMAR 7/19/2007 8/19/2011
Gatifloxacin 0.50% ZYMAXID 12/7/2010
Gatifloxacin Tablets TEQUIN
Injection TEQUIN 12/13/2004
Gemcitabine For Injection 200 mg/vial GEMZAR 11/1/2005 1/25/2011
Galantamine Hydrobromide
4 mg, 8 mg and 12 mg
ANDA No. 077605
ANDA No. 077604
ANDA No. 077608
250 mg and 500 mg
Prior to 12/8/2003
ANDA No. 076457
250 mcg/0.5 mL, 1 mL
PFS Ganirelix Acetate
10 mg/mL, 20 mL and 40 mL vials
Ophthalmic Solution ANDA No. 079084
Ophthalmic Solution
200 mg and 400 mg
Likely Prior to 12/8/2003
Gatifloxacin in Dextrose 5% in Plastic Container
2 mg/mL, 100 mL and 200 mL containers (plastic)
ANDA No. 077983
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Gemcitabine For Injection 1g/vial GEMZAR 11/14/2005
Gemcitabine For Injection 2 g/vial GEMZAR 8/24/2007 11/15/2010
Gemifloxacin Mesylate Tablets 320 mg FACTIVE 3/4/2008
Glatiramer Acetate Injection COPAXONE 12/27/2007
Tablets AVANDARYL 12/22/2006
Tablets AVANDARYL 5/30/2008
Glipizide GLUCOTROL XL
9/8/2003
9/8/2003
Glyburide Tablets GLYNASE 12/22/1997
Tablets GLUCOVANCE 2/18/2004
1/25/2011(Initial approval on 12/18/2008, but converted to tentative approval)ANDA No. 077983
ANDA No. 079183
20 mg/mL, 1mL pre-filled syringe
Glimepiride and Rosiglitazone Maleate
1 mg/4 mg, 2 mg/4 mg and 4 mg/4 mg
Glimepiride and Rosiglitazone Maleate
8 mg/2 mg and 8 mg/4 mg
Extended-release Tablets
2.5 mg, 5 mg and 10 mg
Prior to 12/8/2003
ANDA No. 076467 (10
mg)
ANDA No. 076467
1.5 mg, 3 mg, 4.5 mg and 6 mg
Prior to 12/8/2003
ANDA No. 074591
Glyburide/Metformin Hydrochloride
1.25mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg
Prior to 12/8/2003
ANDA No. 076345
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Glycopyrrolate Tablets 1 mg ROBINUL 8/14/2009
Glycopyrrolate Tablets 1.5 mg ROBINUL FORTE 5/6/2009
Glycopyrrolate Tablets 2 mg ROBINUL FORTE 10/12/2010
Glycopyrrolate Oral Solution 1 mg/5 mL CUVPOSA 6/20/2012
Injection KYTRIL 3/8/2007
Injection KYTRIL 6/1/2004
12/31/2007
1/3/2008
Injection KYTRIL 7/19/2004 12/31/2007
Guaifenesin MUCINEX 6/9/2006
MUCINEX DM 12/17/2008
MUCINEX-D 12/29/2008
Granisetron Hydrochloride
0.1 mg/mL, 1 mL single dose vial
Granisetron Hydrochloride
1 mg/mL, 1 mL vials
ANDA No. 077165
ANDA No. 077963
Granisetron Hydrochloride
1 mg/mL, 4 mL multi-dose vials
ANDA No. 077177
Extended-release Tablets
600 mg and 1.2 gm
Guaifenesin and Dextromethorphan
Extended-release Tablets
600 mg/30 mg and 1200 mg/60 mg
Guaifenesin and Pseudoephedrine Hydrochloride
Extended-release Tablets
600 mg/60 mg and 1200 mg/120 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
INTUNIV 12/29/2009 10/5/2012Guanfacine Hydrochloride
Extended-release Tablets
1 mg, 2 mg, 3 mg and 4 mg
ANDA No. 200881
180-Day Exclusivity Tracker
Exclusivity Decision
Exclusivity Granted (Pre-MMA) (Expiration 4/6/2005)
Exclusivity Granted (Pre-MMA) (Expiration 8/22/2011)
Exclusivity Granted (Pre-MMA) (Expiration 2/14/2005)
Exclusivity Granted (Pre-MMA) (Expiration 6/11/2005)
Exclusivity Granted (Expiration 12/14/2008)
Exclusivity Granted (Expiration 12/14/2008)
Exclusivity Granted (Shared) (Expiration 2/24/2009)
Exclusivity Granted (Shared) (Expiration 2/24/2009)
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (Shared) (Expiration 2/24/2009)
Exclusivity Granted (Shared) (Expiration 2/24/2009)
Exclusivity Granted (Shared) (Expiration 2/24/2009)
Exclusivity Granted (Pre-MMA) (Expiration 2/16/2004)
Exclusivity Granted (Expiration 7/24/2011)
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Granted (Expiration 7/24/2011)
Exclusivity Granted (Expiration 5/14/2011) (Suitability Petition - Docket No. 2006P-0145)
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)
Exclusivity Granted (Pre-MMA) (Expiration 10/31/2004)
Exclusivity Decision
(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 Forfeited (Application Withdrawn (FDC Act § 505(j)(5)(D)(i)(II))
Exclusivity Decision
Exclusivity Presumably Granted
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Tablets MAXZIDE 12/8/1987
Tablets VICOPROFEN 2/24/2006 10/19/2007
Tablets 5 mg/200 mg VICOPROFEN 5/27/2005
Tablets 5 mg/200 mg VICOPROFEN 3/18/2004
Tablets VICOPROFEN
4/11/2003
12/31/2003
Tablets 10 mg/200 mg VICOPROFEN 11/6/2006
Hydrocortisone Butyrate Cream 0.10% 6/28/2010
EXALGO 9/2/2010
16 mg EXALGO 8/2/2010
Oral Solution 5 mg/5mL DILAUDID 2/25/2011
Date of Submission
ANDA Approval Date
Approval Letter
Hydrochlorthiazide and Triamterene
50 mg and 75 mg
Prior to 12/8/2003
ANDA No. 071360
Hydrocodone Bitartrate and Ibuprofen
2.5 mg/200 mg ANDA No. 076642
Hydrocodone Bitartrate and Ibuprofen
Hydrocodone Bitartrate and Ibuprofen
Prior to 12/8/2003
ANDA No. 076642
Hydrocodone Bitartrate and Ibuprofen
7.5 mg/200 mg Prior to
12/8/2003
ANDA No. 076023
ANDA No. 076604
Hydrocodone Bitartrate and Ibuprofen
Likely On or After
12/8/2003
ANDA No. 077723
LOCOID LIPOCREAM
Hydromorphone Hydrochloride
Extended-release Tablets
8 mg and 12 mg
Hydromorphone Hydrochloride
Extended-release Tablets
Hydromorphone hydrochloride
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Injection 10 mg/mL DILAUDID-HP 11/4/2011
Injection 2 mg/mL DILAUDID 6/22/2011
Hydromorphone hydrochloride
Hydromorphone Hydrochloride
180-Day Exclusivity Tracker
Exclusivity Decision
(Suitability Petition - Docket No. 2002P-0270)
Exclusivity Granted (Pre-MMA)
Exclusivity Granted (Pre-MMA) (Expiration 4/17/1988)
Exclusivity Granted (Suitability Petition - Docket No. 2005P-0180)
Exclusivity Granted (Pre-MMA) (Expiration 12/5/2004) (Suitability Petition - Docket No. 2002P-0270)
Exclusivity Granted (Pre-MMA) (Expiration10/11/2004) (second period)
Exclusivity Granted (Suitability Petition - Docket No. 2001P-0442)
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Ibandronate Sodium Injection BONIVA 8/31/2007
Ibandronate Sodium Tablets BONIVA 5/16/2007
3/19/2012
3/19/2012
3/19/2012
Ibuprofen Oral Drops 40 mg/mL
Ibuprofen Oral Suspension 6/29/2007
Ibuprofen Oral Suspension 100 mg/5 mL (RX) MOTRIN
Ibuprofen Oral Suspension 100 mg/5 mL
Ibuprofen Chewable Tablets 1/16/2004
Ibuprofen Lysine Injection NEOPROFEN 10/1/2010
Tablets DUEXIS 12/6/2011
Date of Submission
ANDA Approval Date
Approval Letter
1 mg/mL, 3 mL Vial
2.5 mg and 150 mg
ANDA No. 078948
ANDA No. 078995
ANDA No. 078998
CHILDREN'S MOTRIN DROPS
Prior to 12/8/2003
50 mg/1.25 mL CONCENTRATED MOTRIN INFANT
DROPS
Prior to 12/8/2003
(OTC) CHILDREN'S MOTRIN
Prior to 12/8/2003
50 mg and 100 mg
CHILDREN'S MOTRIN, JUNIOR
STRENGTH MOTRIN
Prior to 12/8/2003
ANDA No. 076359
10 mg/mL, 2 mL vial
Ibuprofen and Famotidine
800 mg/26.6 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Oral Suspension 11/5/2003
Tablets 200 mg/30 mg 4/17/2001
Capsules 200 mg/30 mg 12/27/2004
Ifosfamide For Injection IFEX 5/28/2002
Ifosfamide Injection IFEX
Ifosfamide/ Mesna IFEX/MESNEX KIT 2/26/2002
Ifosfamide/ Mesna IFEX/ MESNEX KIT
Imatinib Mesylate Tablets GLEEVEC 3/12/2007
Imiquimod Cream 5% ALDARA 10/17/2006 2/25/2010
Ibuprofen and Pseudoephedrine Hydrochloride
100 mg/ 15 mg per 5 mL
CHILDREN'S MOTRIN COLD
Prior to 12/8/2003
ANDA No. 076478
Ibuprofen and Pseudoephedrine Hydrochloride
ADVIL COLD AND SINUS
Prior to 12/8/2003
ANDA No. 074567
Ibuprofen Potassium and Pseudoephedrine Hydrochloride
ADVIL COLD AND SINUS
1 g/vial and 3 g/vial
Prior to 12/8/2003
ANDA No. 076078
50 mg/mL, 20 mL vials and 60 mL vials
Prior to 12/8/2003
For Injection/ Injection Kit
1 g/vial; 100 mg/mL, 10 mL vials and 3 g/vial; 100 mg/mL, 10 mL vials
Prior to 12/8/2003
ANDA No. 075874
Injection/ Injection Kit
50 mg/mL, 20 mL and 60 mL vials; 100 mg/mL, 10 mL vial
Prior to 12/8/2003
100 mg and 400 mg
ANDA No. 078548
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Indomethacin 75 mg INDOCIN SR
Irbesartan Tablets AVAPRO 5/25/2004 3/30/2012
Tablets AVALIDE 11/10/2004 3/30/2012
Tablets AVALIDE 6/6/2006 3/30/2012
Irinotecan Hydrochloride Injection CAMPTOSAR 7/26/2004 2/20/2008
Itraconazole Capsules 100 mg SPORANOX 5/28/2004
Ixabepilon Injection IXEMPRA KIT 4/16/2012
Extended-release Capsules
Prior to 12/8/2003
75 mg, 150 mg and 300 mg
ANDA No. 077159
Irbesartan and Hydrochlorothiazide
150 mg/12.5 mg and 300 mg/12.5 mg
ANDA No. 077369
Irbesartan and Hydrochlorothiazide
300 mg/25 mg ANDA No. 077369
20 mg/mL, 2 mL and 5 mL vials
ANDA No. 077219
Prior to 12/8/2003
ANDA No. 076104
15 mg/vial and 45 mg/vial, single-use vials
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
No Exclusivity Granted (Pre-MMA; Rx-to-OTC Switch)
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)) (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)
Exclusivity Relinquished (Pre-MMA)
See ANDA No. 074937
Exclusivity Decision
Exclusivity Granted (Pre-MMA)
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA) (Expiration 7/29/2004)
Exclusivity Granted (Pre-MMA) (Expiration 4/6/2002)
Exclusivity Granted (Pre-MMA) (Expiration 10/5/2002)
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 Granted (Expiration 9/26/2012)
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))
Exclusivity Granted (Pre-MMA) (Expiration 8/8/2005)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Ketoconazole Foam 2% EXTINA 7/30/2009 8/25/2011
Ketoprofen Capsules ORUDIS
Ketorolac Tromethamine Injection TORADOL
Ketorolac Tromethamine Opthalmic Solution 0.45% ACUVAIL 8/24/2011
0.50% ACULAR
0.40% ACULAR LS 1/28/2005
Ketorolac Tromethamine Tablets 10 mg TORADOL
Ketorolac Tromethamine Nasal Spray SPRIX 3/12/2012
Ketotifen Fumarate 0.025% ZADITOR 12/23/2004 5/9/2006
Date of Submission
ANDA Approval Date
Approval Letter
ANDA No. 091550
25 mg, 50 mg and 75 mg
Prior to 12/8/2003
15 mg/mL and 30 mg/mL
Prior to 12/8/2003
Ketorolac Tromethamine Ophthalmic Solution Prior to
12/8/2003
Ketorolac Tromethamine Ophthalmic Solution
Prior to 12/8/2003
15.75 mg/spray
Ophthalmic Solution ANDA No.
077354
180-Day Exclusivity Tracker
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Forfeiture)
No Exclusivity Granted (Pre-MMA)
Exclusivity Granted (Expiration 2/21/2012)
Exclusivity Granted (Expiration 12/30/2006)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Lactulose Oral Syrup 10 g/15 mL CEPHULAC
Lactulose Oral Syrup 10 g/15 mL CHRONULAC
Lamivudine Tablets 100 mg EPIVIR-HBV 10/31/2007
Lamivudine Tablets EPIVIR 10/16/2007
Tablets COMBIVIR 6/26/2007 5/25/2011
Lamivudine Oral Solution 10 mg/mL EPIVIR 11/22/2011
Lamotrigine Tablets LAMICTAL 8/30/2006
Lamotrigine Chewable Tablets LAMICTAL CD 6/21/2006
Lamotrigine LAMICTAL ODT 12/21/2009
Lansoprazole PREVACID 12/5/2005
Date of Submission
ANDA Approval Date
Approval Letter
Prior to 12/8/2003
Prior to 12/8/2003
150 mg and 300 mg
Lamivudine and Zidovudine
150 mg/300 mg
ANDA No. 079081
25 mg, 100 mg, 150 mg and 200 mg
Prior to 12/8/2003
ANDA No. 076388
2 mg, 5 mg and 25 mg
Prior to 12/8/2003
ANDA No. 076420
Orally Disintegrating Tablets
25 mg, 50 mg, 100 mg, and 200 mg
Delayed-release Pellets/Capsules
15 mg and 30 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Lansoprazole PREVACID 12/27/2006 10/15/2010
Lanthanum Carbonate Chewable Tablet FOSRENOL 10/27/2008
Lapatinib Ditosylate Tablets 250 mg TYKERB 3/14/2011
Latanoprost 0.005% XALATAN
Lenalidomide Capsules REVLIMID 8/30/2010
Lenalidomide Capsules 25 mg REVLIMID 7/12/2010
Letrozole Tablets 2.5 mg FEMARA 3/2/2006 12/24/2008
Leuprolide Acetate Injection (depot) 7.5 mg/vial LUPRON DEPOT
Inhalation Solution XOPENEX 6/20/2005 4/9/2008
Inhalation Solution 0.25% XOPENEX 5/23/2006 3/20/2009
Levalbuterol Tartrate Inhalation Aerosol XOPENEX 2/27/2012
Levetiracetam Tablets KEPPRA
Levetiracetam Tablets 1000 mg KEPPRA 1/24/2007
Delayed-release Orally Disintegrating Tablets
15 mg and 30 mg
ANDA No. 078730
500 mg, 750 mg and 1000 mg
Ophthalmic Solution Prior to
12/8/2003
5 mg, 10 mg and 15 mg
ANDA No. 078190
Prior to 12/8/2003
Levalbuterol Hydrochloride
0.0103%, 0.021% and 0.042%
ANDA No. 077756
Levalbuterol Hydrochloride
ANDA No. 078309
0.045 mg/actuation
250 mg, 500 mg and 750 mg
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Levetiracetam KEPPRA XR 1/7/2011
9/12/2011
9/12/2011
9/12/2011
9/12/2011
9/12/2011
9/12/2011
9/12/2011
10/4/2011
12/19/2011
Oral Solution 0.5 mg/mL XYZAL 1/14/2009 11/7/2011
Tablets 5 mg XYZAL 12/17/2007 11/26/2010
Extended-release Tablets
500 mg and 750 mg
ANDA No. 091093
ANDA No. 091261
ANDA No. 091285
ANDA No. 091291
ANDA No. 091430
ANDA No. 091399
ANDA No. 091557
ANDA No. 091360
ANDA No. 200475
Levocetirizine Dihydrochloride
ANDA No. 091263
Levocetirizine Dihydrochloride
ANDA No. 090229
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Levofloxacin Injection
Levofloxacin Injection 25 mg/mL LEVAQUIN
Levofloxacin 0.50% QUIXIN
Levofloxacin Oral Solution 25 mg/mL LEVAQUIN 7/30/2009
Levofloxacin Tablets LEVAQUIN
Levoleucovorin Calcium Injection FUSILEV 10/26/2011
Tablets LYBREL 10/5/2007
Tablets SEASONALE 3/29/2004 9/6/2006
Tablets LOSEASONIQUE 11/16/2009
10/25/2011
10/26/2011
5 mg/mL; 50 mL, 100 mL and 150 mL vials
LEVAQUIN IN DEXTROSE 5% IN
PLASTIC CONTAINER
Prior to 12/8/2003
Prior to 12/8/2003
Ophthalmic Solution Prior to
12/8/2003
250 mg, 500 mg and 750 mg
Prior to 12/8/2003
10/15/2004 (Converted to a
Tentative Approval
2/1/2005)
ANDA No. 076276
1/26/2005 (Converted to a
Tentative Approval
7/12/2006)
ANDA No. 076361
10 mg/mL, 17.5 mL vial and 25 mL vial
Levonorgestrel and Ethinyl Estradiol
0.09 mg/0.02 mg
Levonorgestrel and Ethinyl Estradiol
0.15 mg/0.03 mg
ANDA No. 077101
Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol
0.1 mg/0.02 mg and 0.01 mg
ANDA No. 200407
ANDA No. 091674
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets SEASONIQUE 1/22/2008 5/31/2011
Levothyroxine Sodium Tablets LEVOXYL
Lidocaine Topical Patch 5% LIDODERM 11/13/2009 8/23/2012
Linezolid Injection ZYVOX 12/29/2009
Linezolid Injection ZYVOX 9/1/2009 6/27/2012
Linezolid Oral Suspension 100 mg/5 mL ZYVOX 8/3/2009
Linezolid Tablets 600 mg ZYVOX 12/21/2005
Capsules VYVANSE 2/23/2011
Chewable Tablets 2 mg/125 mg 8/30/2002
Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol
0.15 mg/0.03 mg/0.01 mg
ANDA No. 078834
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
Prior to 12/8/2003
ANDA No. 200675
2 mg/mL, 100 mL bag
2 mg/mL, 300 mL bag
ANDA No. 200222
Lisdexamfetamine Dimesylate
20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
Loperamide Hydrochloride and Simethicone
IMODIUM ADVANCED
Prior to 12/8/2003
ANDA No. 076029
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets 12/29/2004 9/6/2006
Lopinavir and Ritonavir Tablets KALETRA 12/23/2008
Loratadine Syrup 1 mg/mL CLARITIN 11/7/2003
Loratadine Tablets 10 mg CLARITIN 1/21/2003
Loratadine 10 mg CLARITIN REDITABS 2/10/2003
5 mg/120 mg 1/30/2003
10 mg/240 mg 2/21/2003
Losartan Potassium Tablets COZAAR 4/6/2010
Tablets HYZAAR 5/24/2004 4/6/2010
Tablets HYZAAR 4/4/2006
Loperamide Hydrochloride and Simethicone
2 mg/125 mg (OTC)
IMODIUM ADVANCED
ANDA No. 077500
100 mg/25 mg and 200 mg/50 mg
Prior to 12/8/2003
ANDA No. 075505
Prior to 12/8/2003
ANDA No. 075209
Orally Disintegrating Tablets
Prior to 12/8/2003
ANDA No. 075822
Loratadine/ Pseudoephedrine
Extended-release Tablets
CLARITIN D-12 HOUR
Prior to 12/8/2003
ANDA No. 076050
Loratadine/ Pseudoephedrine
Extended-release Tablets
CLARITIN D-24 HOUR
Prior to 12/8/2003
ANDA No. 075706
25 mg, 50 mg, and 100 mg
On or After 12/8/2003
ANDA N0. 076958
Losartan Potassium and Hydrochlorothiazide
50 mg/12.5 mg and 100 mg/25 mg
ANDA No. 077157
Losartan Potassium and Hydrochlorothiazide
100 mg/12.5 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Lovastatin and Niacin 20 mg/500 mg ADVICOR 9/22/2008
Lovastatin and Niacin 20 mg/750 mg ADVICOR 12/17/2008
Lovastatin and Niacin ADVICOR 5/22/2008
Lovastatin and Niacin ADVICOR 11/19/2009
Lubiprostone Capsules AMITIZA 8/20/2012
Extended-release Tablets
Extended-release Tablets
Extended-release Tablets
20 mg/1000 mg
Extended-release Tablets
40 mg/1000 mg
8 mcg and 24 mcg
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Granted (Expiration 5/15/2012)
Exclusivity Granted (Pre-MMA) (Expiration 1/18/2009)
Exclusivity Granted (Pre-MMA) (Expiration 2/25/2007; 5 mg) (Expiration 2/25/2006; 25 mg)
No Exclusivity Granted (Forfeiture; Presumably Patent Expiration)
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted
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 (Pre-MMA) (patent exp)
Exclusivity Granted (Expiration 02/16/2013)
No Exclusivity Granted (Pre-MMA) (patent exp)
Exclusivity Forfeited - Patent Expiration (FDC Act § 505(j)(5)(D)(i)(VI))
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Shared) (Expiration 3/10/2012)
Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Granted
Exclusivity Granted
Exclusivity Granted
No Exclusivity Granted (Pre-MMA) (patent expiration)
Exclusivity Granted (Pre-MMA) (250 mg & 500 mg)
Exclusivity Granted (Pre-MMA) (750 mg)
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA)
Exclusivity Forfeited (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/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))
Exclusivity Decision
Tentative Approval(s) Granted
No Exclusivity Granted
Exclusivity Granted (Expiration 5/12/2007)
Exclusivity Granted (Pre-MMA) (Expiration 8/20/2004)
Exclusivity Granted (Pre-MMA) (Expiration 7/21/2003)
Exclusivity Granted (Pre-MMA) (Expiration 8/9/2003)
Exclusivity Granted (Pre-MMA) (Expiration 7/30/2003)
Exclusivity Granted (Pre-MMA) (Expiration 11/29/2003)
Exclusivity Granted (Expiration 10/3/2010)
FDA Letter Decision
Exclusivity Granted (Expiration 10/3/2010)
FDA Letter Decision
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Malathion Topical Lotion 0.50% OVIDE 3/16/2011
Maraviroc Tablets SELZENTRY 8/8/2011
Tablets 250 mg LARIAM 2/20/2002
Megestrol Acetate Oral Suspension 40 mg/mL MEGACE 7/25/2001
Megestrol Acetate Oral Suspension 125 mg/mL MEGACE ES 4/27/2011
Meloxicam Oral Suspension 7.5 mg/5 mL MOBIC 12/17/2009
Tablets NAMENDA 10/16/2007
4/14/2010
5/5/2010
Mesalamine 400 mg ASACOL 6/22/2007
Mesalamine 800 mg ASACOL HD 7/13/2011
Mesalamine 1.2 g LIALDA 12/16/2009
Date of Submission
ANDA Approval Date
Approval Letter
150 mg and 300 mg
Mefloquine Hydrochloride Prior to
12/8/2003ANDA No. 076175
Prior to 12/8/2003
ANDA No. 075671
Memantine Hydrochloride
5 mg and 10 mg
ANDA No. 090048
ANDA No. 090058
Delayed-release Tablets
Delayed-release Tablets
Delayed-release Tablets
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Mesalamine 0.375 g APRISO 4/3/2012
Metaxalone Tablets 400 mg SKELAXIN
Metaxalone Tablets 800 mg SKELAXIN 11/4/2004 3/31/2010
500 mg GLUCOPHAGE XR
6/16/2004
10/28/2003
7/30/2004
10/1/2004
750 mg GLUCOPHAGE XR 10/14/2004
FORTAMET 10/14/2008 6/29/2011
GLUMETZA 7/27/2009
10 mg RITALIN LA 5/21/2007
METADATE CD 5/13/2005 7/19/2012
Extended-release Capsules
Prior to 12/8/2003
ANDA No. 040445
Metformin Hydrochloride Extended-release Tablets
Prior to 12/8/2003
ANDA No. 076172
ANDA No. 76545
ANDA No. 076249
ANDA No. 076450
Metformin Hydrochloride Extended-release Tablets
Prior to 12/8/2003
ANDA No. 76863
Metformin Hydrochloride Extended-release Tablets
500 mg and 1000 mg
ANDA No. 090692
Metformin Hydrochloride Extended-release Tablets
500 mg and 1000 mg
Methylphenidate Hydrochloride
Extended-release Capsules
Methylphenidate Hydrochloride
Extended-release Capsules
10 mg, 20 mg and 30 mg
ANDA No. 77707
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
RITALIN LA 8/21/2006 12/1/2011
40 mg METADATE CD 3/15/2007 7/19/2012
CONCERTA 7/19/2005 12/28/2012
Oral Solution METHYLIN 4/13/2010 7/23/2010
Methylphenidate DAYTRANA 4/13/2011
Injection REGLAN
METOZOLV ODT 8/24/2010
Metoprolol Succinate TOPROL XL
5/18/2007
7/31/2006
Methylphenidate Hydrochloride
Extended-release Capsules
20 mg, 30 mg and 40 mg
ANDA No. 078458
Methylphenidate Hydrochloride
Extended-release Capsules
ANDA No. 078873
Methylphenidate Hydrochloride
Extended-release Tablets
18 mg, 27 mg, 36 mg and 54 mg
ANDA No. 202608
Methylphenidate Hydrochloride
5 mg/5 mL and10 mg/5 mL
ANDA No. 091601
Transdermal System
10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs and 30 mg/9 hrs
Metoclopramide Hydrochloride
5 mg/mL, 2 mL, 10 mL, 20 mL and 30 mL vials
Prior to 12/8/2003
Metoclopramide Hydrochloride
Orally Disintegrating Tablets
5 mg and 10 mg
Extended-release Tablets
25 mg, 50 mg, 100 mg and
200 mg
Prior to 12/8/2003
ANDA No. 076640
On or After 12/8/2003
ANDA No. 076969
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Metronidazole Vaginal Gel 0.75% 9/2/2004 10/31/2006
Metronidazole Topical Gel 1% METROGEL 10/21/2008 7/22/2011
Miconazole Nitrate 2% and 1.2 g 12/5/2007 6/2/2010
SOLODYN
2/3/2009
3/17/2009
8/13/2009
7/20/2010
SOLODYN 12/2/2010
SOLODYN 11/19/2009
105 mg SOLODYN 12/28/2010
Minoxidil 5% MEN’S ROGAINE 4/6/2009 4/28/2011
METROGEL-VAGINAL
ANDA No. 077264
ANDA No. 090903
Vaginal Cream and Suppository
MONISTAT 1 COMBINATION PACK
ANDA No. 079114
Minocycline Hydrochloride
Extended-release Tablet
45 mg, 90 mg and 135 mg
PIV received prior to
2/5/2009
ANDA No. 090024
ANDA No. 065485
ANDA No. 090422
ANDA No. 090911
Minocycline Hydrochloride
Extended-release Tablet
55 mg and 80 mg
Minocycline Hydrochloride
Extended-release Tablet
65 mg and 115 mg
Minocycline Hydrochloride
Extended-release Tablet
Topical Aerosol Foam
ANDA No. 091344
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Mirtazapine Tablets REMERON
1/24/2003
4/22/2004
Mirtazapine REMERON SOLTAB
12/17/2003
8/31/2005
6/28/2005
Modafinil Tablets PROVIGIL
Moexipril Hydrochloride Tablets UNIVASC 5/8/2003
Tablets UNIRETIC 1/15/2004
Mometasone Furoate Nasal Spray 50 mcg/ Spray NASONEX 8/7/2009
Mometasone Furoate 0.10% ELOCON
7.5 mg, 15 mg, 30 mg, and 45 mg
Prior to 12/8/2003
ANDA No. 076119
ANDA No. 076541
Orally Disintegrating Tablets
15 mg, 30 mg and 45 mg
Prior to 12/8/2003
ANDA No. 076307
ANDA No. 076689
ANDA No. 076901
100 mg and 200 mg
Prior to 12/8/2003
ANDA No. 076596
7.5 mg and 15 mg
Priot to 12/8/2003
ANDA No. 076204
Moexipril Hydrochloride and Hydrochlorothiazide
7.5mg/12.5mg 15 mg/25 mg and 15 mg/12.5 mg
Topical Solution (Cream)
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Mometasone Furoate 0.10% ELOCON 6/10/2004 4/6/2005
Montelukast Tablets 10 mg SINGULAIR 2/20/2007
Montelukast Sodium Chewable Tablets SINGULAIR 12/26/2006
Montelukast Sodium Oral Granules 4 mg 10/17/2008 8/3/2012
Morphine Sulfate AVINZA 6/4/2007
Morphine Sulfate AVINZA 7/30/2009
EMBEDA 5/28/2010
60 mg/2.4 mg EMBEDA 5/25/2010
100 mg/4 mg EMBEDA 5/3/2010
0.50% VIGAMOX 12/22/2005
10.50% MOXEZA 2/29/2012
Tablets 400 mg AVELOX
Mycophenolic Acid 180 mg MYFORTIC 6/4/2009
Topical Solution (Lotion)
ANDA No. 077180
4 mg and 5 mg
SINGULAR GRANULES
ANDA No. 090955
Extended-release Capsules
30 mg, 60 mg, 90 mg and 120 mg
Extended-release Capsules
45 mg and 75 mg
Morphine Sulfate and Naltrexone Hydrochloride
Extended-release Capsules
30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mg
Morphine Sulfate and Naltrexone Hydrochloride
Extended-release Capsules
Morphine Sulfate and Naltrexone Hydrochloride
Extended-release Capsules
Moxifloxacin Hydrochloride
Ophthalmic Solution/Drops
Moxifloxacin Hydrochloride
Ophthalmic Solution
Moxifloxacin Hydrochloride
Likely Prior to 12/8/2003
Delayed-release Tablets
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Mycophenolic Acid 360 mg MYFORTIC 2/2/2009
Mycophenolic Mofetil Tablets 500 mg CELLCEPT 4/22/2009
Mycophenolic Mofetil Capsules 250 mg CELLCEPT 4/22/2009
Mycophenolic Mofetil 200 mg/mL CELLCEPT 3/25/2011
Delayed-release Tablets
On or After 12/8/2003
ANDA No. 090499
On or After 12/8/2003
ANDA No. 090419
For Oral Suspension
180-Day Exclusivity Tracker
Exclusivity Decision
Exclusivity Granted (Shared)
Exclusivity Granted (Shared)
Exclusivity Granted (Pre-MMA) (Expiration 11/3/2002)
Exclusivity Granted (Pre-MMA) (Expiration 1/12/2002)
Exclusivity Decision
Exclusivity Granted (Pre-MMA;Shared)
Tentative Approval(s) Granted
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) (Expiration 4/12/2005)
Exclusivity Granted (Expiration 3/28/2012)
Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (Expiration 7/1/2012)
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; Pre-MMA/MMA-Straddle; Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))
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 Decision
Exclusivity Granted
Exclusivity Granted
Exclusivity Granted (QI Act Shared)
Exclusivity Granted (QI Act Shared)
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/Forfeited (180-Day Punt) (Expiration 12/24/2010) (Failure-to-Market Delisting - FDC Act § 505(j)(5)(D)(i)(I))
Exclusivity Decision
No Exclusivity Granted (Forfeiture)
Exclusivity Relinquished (Pre-MMA)
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 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)
See ANDA No. 076679
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
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))
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Granted
Exclusivity Granted
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Nabumetone Tablets RELAFEN
5/26/2000
6/6/2000
9/24/2001
Naproxen Sodium NAPRELAN
VIMOVO 11/5/2010
Tablets 500 mg/85 mg TREXIMET 7/23/2008
Nateglinide Tablets STARLIX 12/22/2004
9/9/2009
9/9/2009
9/9/2009
Date of Submission
ANDA Approval Date
Approval Letter
500 mg and 750 mg
Prior to 12/8/2003
ANDA No. 075189
ANDA No. 075179
ANDA No. 075189
Extended-release Tablets
375 mg (base) and 500 mg (base)
Prior to 12/8/2003
Naproxen and Esomeprazole Magnesium
Delayed-release Tablet
375 mg/20 mg and 500 mg/20 mg
Naproxen Sodium and Sumatriptan Succinate
60 mg and 120 mg
ANDA No. 077463
ANDA No. 077467
ANDA No. 077461
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Nateglinide Tablets STARLIX 12/22/2004
9/9/2009
Nebivolol Hydrochloride Tablets BYSTOLIC 12/19/2011
Tablets SERZONE
Niacin NIASPAN
4/14/2005
4/26/2005
Niacin and Simvastatin SIMCOR 2/12/2010
Niacin and Simvastatin 750 mg/20 mg SIMCOR 2/17/2010
Niacin and Simvastatin SIMCOR 9/17/2009
Niacin and Simvastatin SIMCOR 2/4/2011
Niacin and Simvastatin 500 mg/40 mg SIMCOR 2/9/2011
Injection CARDENE 12/27/2006
Nicotine HABITROL
60 mg and 120 mg
ANDA No. 077461
2.5 mg, 5 mg, 10 mg, and 20 mg
Nefazodone Hydrochloride
50 mg, 100 mg, 150 mg 200 mg and 250 mg
Prior to 12/8/2003
Extended-release Tablets
500 mg, 750 mg and 1000 mg
Prior to 12/8/2003
ANDA No. 076250
ANDA No. 076378
Extended-release Tablets
500 mg/20 mg
Extended-release Tablets
Extended-release Tablets
1000 mg/20 mg
Extended-release Tablets
1000 mg/40 mg
Extended-release Tablets
Nicardipine Hydrochloride
2.5 mg/mL, 10 mL Ampoules
Transdermal System
7 mg/day, 14 mg/day and 21 mg/day
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Nicotine Polacrilex Troche/Lozenge COMMIT 1/31/2006
Nifedipine Capsules PROCARDIA 7/10/1989
Nifedipine ADALAT CC
3/10/2000
12/4/2000
8/16/2002
Nifedipine PROCARDIA XL
12/17/1999
9/27/2000
3/23/2004
Nisoldipine SULAR 3/2/2009 1/26/2011
Nisoldipine SULAR 11/7/2007
2 mg and 4 mg Post
12/8/2003ANDA No.
077007
10 mg and 20 mg
Prior to 12/8/2003
ANDA No. 072409
Extended-release Tablets
30 mg, 60 mg and 90 mg
Prior to 12/8/2003
ANDA No. 075128
ANDA No. 075269
ANDA No. 076070
Extended-release Tablets
30 mg, 60 mg and 90 mg
Prior to 12/8/2003
ANDA No. 075108
ANDA No. 075289
ANDA No. 075414
Extended-release Tablets
8.5 mg and 17 mg
ANDA No. 091001
Extended-release Tablets
20 mg and 30 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Nisoldipine SULAR 11/28/2008 1/26/2011
Nisoldipine 40 mg SULAR 6/11/2007
Capsules 75 mg/25 mg MACROBID 3/22/2004
Nitroglycerin Sublingual Tablets NITROSTAT 10/19/2005
Nitroglycerin 0.1 mg/hr TRANSDERM-NITRO
Nitroglycerin NITRO-DUR
Nitroglycerin Sublingual Spray 4/17/2012
Nizatidine Capsules AXID
Nizatidine Oral Solution 15 mg/mL AXID 5/14/2008 11/18/2009
ORTHO EVRA 3/22/2007
Extended-release Tablets
25.5 mg and 34 mg
ANDA No. 091001
Extended-release Tablets
Nitrofurantoin Monohydrate/ Macrocrystals
Prior to 12/8/2003
ANDA No. 076648
0.3 mg, 0.4 mg and 0.6 mg
Transdermal System
Prior to 12/8/2003
Transdermal System
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
Prior to 12/8/2003
400 mcg/spray, 4.9 g and 12 g bottles
NITROLINGUAL PUMPSPRAY
150 mg and 300 mg
Prior to 12/8/2003
ANDA No. 090576
Norelgestromin and Ethinyl Estradiol
Transdermal System
0.15 mg/0.02 mg per 24 hours
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets FEMHRT 11/6/2009
Tablets ESTROSTEP FE 10/26/2007
Tablets ESTROSTEP 21 10/26/2007
Tablets LOESTRIN 24 FE 4/17/2006 9/1/2009
Tablets LO LOESTRIN FE 4/29/2011
Chewable Tablets 4/27/2007 8/5/2010
Chewable Tablets GENERESS FE 8/5/2011
Tablets 8/30/2002
Norethindrone Acetate/ Ethinyl Estradiol
1 mg/0.005 mg
Prior to 12/8/2003
ANDA No. 076221
Norethindrone Acetate/ Ethinyl Estradiol
1 mg/ 0.02 mg, 1 mg/0.03 mg and 1 mg /0.035 mg
Prior to 12/8/2003
ANDA No. 076105
Norethindrone Acetate/ Ethinyl Estradiol
1 mg/0.02 mg, 1 mg/ 0.03 mg and 1 mg /0.035 mg
Prior to 12/8/2003
ANDA No. 076405
Norethindrone Acetate/ Ethinyl Estradiol and Ferrous Fumarate
1 mg/0.02 mg and 75 mg
ANDA No. 078267
Norethindrone Acetate and Ethinyl Estradiol / Ethinyl Estradiol and Ferrous Fumarate
1 mg/0.01 mg, 0.01 mg and 75 mg
Norethindrone and Ethinyl Estradiol and Ferrous Fumarate
0.4 mg/0.035 mg
OVCON-35 FE FEMCON FE NDA 21-
490 ANDA No. 078965
Norethindrone and Ethinyl Estradiol and Ferrous Fumarate
0.8 mg/0.025 mg and 75 mg
Norethindrone/ Ethinyl Estradiol
0.5 mg/ 0.035 mg, 0.75 mg/ 0.035 mg and 1 mg /0.035 mg
ORTHO-NOVUM 7/7/7, 21 AND 28 DAY
Prior to 12/8/2003
ANDA No. 075478
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Tablets 6/29/2009
Tablets
Capsules PAMELOR
Norgestimate/ Ethinyl Estradiol
0.18 mg /0.025 mg, 0.215 mg /0.025 mg and 0.25 mg /0.025 mg
ORTHO TRI-CYCLEN LO, 28 DAY
Prior to 12/8/2003
ANDA No. 076784
Norgestimate/ Ethinyl Estradiol
0.18 mg /0.035 mg, 0.215 mg /0.035 mg and 0.25 mg /0.035 mg
ORTHO TRI-CYCLEN, 21 AND 28
DAY
Prior to 12/8/2003
12/18/2002 (Rescinded;
Consent Judgment &
Order); 12/29/2003
(Reapproved)
ANDA No. 075808
Nortriptyline Hydrochloride
10 mg, 25 mg, 50 mg and 75 mg
Prior to 12/8/2003
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Granted (Shared)
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)
Exclusivity Granted (Shared)
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))
Exclusivity Decision
No Exclusivity Granted (Forfeiture)
FDA Letter Decision
Exclusivity Granted (Pre-MMA) (1000 mg)
Exclusivity Granted (Pre-MMA) (500 mg & 750 mg)
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (Expiration 8/21/2006)
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)
No Exclusivity Granted (Forfeited)
Exclusivity Decision
Exclusivity Granted
No Exclusivity Granted (Pre-MMA)
Exclusivity Granted
Exclusivity Presumably Forfeited - Patent Expiration (FDC Act § 505(j)(5)(D)(i)(VI))
Exclusivity Granted (Pre-MMA) (Expiration 9/19/2004)
Exclusivity Forfeited (Application Withdrawn (FDC Act § 505(j)(5)(D)(i)(II))
Exclusivity Decision
Exclusivity Presumably Granted (Pre-MMA)
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)
No Exclusivity Granted (Pre-MMA) (Applicant did not maintain a consistent PIV certification)
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))
Exclusivity Granted (Expiration 9/21/2011)
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
Exclusivity Granted (Pre-MMA) (Expiration 12/29/2009)
No Exclusivity Granted (Pre-MMA) - (28-day) (Patent Expiration & Conversion to Paragraph III)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Octreotide Acetate Injection 3/28/2005
Octreotide Acetate Injection SANDOSTATIN 4/8/2005
Octreotide Acetate Injection 1/17/2008
Ofloxacin Otic Solution 0.30% FLOXIN 9/28/2007
Olanzapine Tablets ZYPREXA 10/24/2011
Olanzapine Tablets 20 mg ZYPREXA 10/24/2011
Date of Submission
ANDA Approval Date
Approval Letter
0.05 mg /mL, 0.1 mg /mL and 0.5 mg/mL, 1 mL vials
SANDOSTATIN (PRESERVATIVE
FREE)
Prior to 12/8/2003
ANDA No. 076313
0.2 mg/mL and 1 mg /mL, 5 mL vials
Prior to 12/8/2003
ANDA No. 076330
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)
OCTREOTIDE ACETATE
INJECTION
Prior to 12/8/2003
ANDA No. 076527
2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg
Prior to 12/8/2003
ANDA No. 076000
Prior to 12/8/2003
ANDA No. 076133
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Olanzapine ZYPREXA ZYDIS
Capsules 3 mg/25 mg SYMBYAX 5/8/2008
Capsules SYMBYAX 1/10/2005 6/19/2012
Olmesartan Medoxomil Tablets BENICAR 4/25/2006
Tablets BENICAR HCT 5/11/2007
Tablets BENICAR HCT 2/15/2007
Nasal Spray PATANASE 6/29/2009
0.10% PATANOL 7/17/2006
0.20% PATADAY 9/8/2008
Capsules 1 g LOVAZA 11/10/2008
Omeprazole PRILOSEC
Orally Disintegrating Tablets
5 mg, 10 mg, 15 mg and 20 mg
Prior to 12/8/2003
Olanzapine and Fluoxetine Hydrochloride
Olanzapine and Fluoxetine Hydrochloride
6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg
ANDA No. 077528
5 mg, 20 mg and 40 mg
Olmesartan Medoxomil and Hydrochlorothiazide
20 mg/12.5 mg
Olmesartan Medoxomil and Hydrochlorothiazide
40 mg/12.5 mg and 40 mg/25 mg
Olopatadine Hydrochloride
0.665 mg/ Spray
Olopatadine Hydrochloride
Ophthalmic Solution
Olopatadine Hydrochloride
Ophthalmic Solution
Omega-3-Acid Ethyl Esters
Delayed-release Capsules
10 mg, 20 mg and 40 mg
Prior to 12/8/2003
11/16/2001 & 5/30/2008
ANDA No. 075347
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Omeprazole PRILOSEC
Capsules ZEGERID 4/30/2007 5/25/2010
Capsules 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
Injection ZOFRAN
Injection ZOFRAN
Injection
Oral Solution 4 mg/5 mL ZOFRAN 12/20/2004 12/26/2006
Delayed-release Capsules
10 mg, 20 mg and 40 mg
Prior to 12/8/2003
Omeprazole and Sodium Bicarbonate
20 mg/1100 mg and 40 mg/1100 mg
ANDA No. 078966
Omeprazole and Sodium Bicarbonate
20 mg/1100 mg
Omeprazole and Sodium Bicarbonate
Powder for Oral Suspension
20mg/1680mg per packet
Omeprazole and Sodium Bicarbonate
Powder for Oral Suspension
40 mg/1680 mg per packet
Delayed-release Capsules
ANDA No. 078878
Ondansetron Hydrochloride
2 mg/mL, 2 mL vials (Preservative free)
Prior to 12/8/2003
Ondansetron Hydrochloride
2 mg/mL, 20 mL vials
Prior to 12/8/2003
Ondansetron Hydrochloride
0.64 mg/mL, 50 mL container (plastic)
ZOFRAN IN PLASTIC CONTAINER
Prior to 12/8/2003
Ondansetron Hydrochloride
ANDA No. 076960
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
ZOFRAN ODT 12/26/2006
ZOFRAN ODT 11/24/2004 12/26/2006
Tablets ZOFRAN
12/26/2006
12/26/2006
Orlistat Capsules 60 mg ALLI 9/8/2010
Oseltamivir Phosphate Capsules TAMIFLU 8/2/2011
Oseltamivir Phosphate Capsule 75 mg TAMIFLU 11/15/2010
Oxaliplatin Injection ELOXATIN 2/9/2007
8/7/2009
8/7/2009
Oxaliplatin Injection ELOXATIN 3/23/2011
Ondansetron Hydrochloride
Orally Disintegrating Tablets
4 mg and 8 mg Prior to
12/8/2003ANDA No. 076506
Ondansetron Hydrochloride
Orally Disintegrating Tablets
16 mg and 24 mg
ANDA No. 077406
Ondansetron Hydrochloride
4 mg, 8 mg, 16 mg, and 24 mg
Prior to 12/8/2003
ANDA No. 076183
ANDA No. 076559
30 mg and 45 mg
5 mg/mL, 10 mL and 20 mL vials
ANDA No. 078812
ANDA No. 078813
5 mg/mL, 40 mL vial
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Oxaliplatin For Injection ELOXATIN 2/9/2007
8/7/2009
8/7/2009
9/30/3009
Oxaliplatin Injection 200 mg/40 mL ELOXATIN 7/16/2007
Oxandrolone Tablets OXANDRIN 6/19/2006
Oxazepam Capsules SERAX
Oxcarbazepine Tablets TRILEPTAL 5/5/2006
10/9/2007
10/9/2007
11/15/2007
10/9/2007
12/11/2007
1/11/2008
50 mg/vial and 100 mg/vial
ANDA No. 078810
ANDA No. 078818
ANDA No. 078815
2.5 mg and 10 mg
10 mg, 15 mg and 30 mg
Prior to 12/8/2003
150 mg, 300 mg and 600 mg
ANDA No. 077794
ANDA No. 077795
ANDA No. 077801
ANDA No. 077802
ANDA No. 078005
ANDA No. 078069
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Oxcarbazepine Oral Suspension 300 mg/5 mL TRILEPTAL 12/26/2006 6/26/2009
Oxybutynin 3.9 mg/24 hrs OXYTROL 8/19/2008
Oxybutynin Chloride DITROPAN XL
11/9/2006
11/9/2006
11/9/2006
Oxycodone
3/23/2004
15 mg 2/15/2007
1/3/2007
10 mg 10/25/2010
15 mg 10/28/2010
20 mg 10/29/2010
ANDA No. 078734
Transdermal System Extended-release
Extended-release Tablets
5 mg, 10 mg and 15 mg
Prior to 12/8/2003
ANDA No. 076702
ANDA No. 076644
ANDA No. 076745
Extended-release Tablets
10 mg, 20 mg, 40 mg, 80 mg and 160 mg
OXYCONTIN (NDA 020553)
Prior to 12/8/2003
ANDA No. 076168
3/24/2004 (2/7/2007 - Converted to a Tentative Approval)
ANDA No. 075923
Oxycodone Hydrochloride
Extended-release Tablets
OXYCONTIN (NDA 020553)
Oxycodone Hydrochloride
Extended-release Tablets
30 mg and 60 mg
OXYCONTIN (NDA 020553)
Oxycodone Hydrochloride
Extended-release Tablet
OXYCONTIN (NDA 022272)
Oxycodone Hydrochloride
Extended-release Tablet
OXYCONTIN (NDA 022272)
Oxycodone Hydrochloride
Extended-release Tablet
OXYCONTIN (NDA 022272)
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
10/18/2010
40 mg 10/4/2010
Tablets OXECTA 2/8/2012
OPANA ER 11/23/2007 6/14/2010
OPANA ER 5/29/2008 12/13/2010
30 mg OPANA ER 6/12/2008 7/22/2010
5 mg 3/26/2012
3/23/2012
4/3/2012
Oxycodone Hydrochloride
Extended-release Tablet
30 mg, 60 mg and 80 mg
OXYCONTIN (NDA 022272)
Oxycodone Hydrochloride
Extended-release Tablet
OXYCONTIN (NDA 022272)
Oxycodone Hydrochloride
5 mg and 7.5 mg
Oxymorphone Hydrochloride
Extended-release Tablets
5 mg, 10 mg, 20 mg and 40 mg
ANDA No. 079087
Oxymorphone Hydrochloride
Extended-release Tablets
7.5 mg and 15 mg
ANDA No. 079046
Oxymorphone Hydrochloride
Extended-release Tablets
ANDA No. 079087
Oxymorphone Hydrochloride
Extended-release Tablets
OPANA ER (NDA 201655)
Oxymorphone Hydrochloride
Extended-release Tablets
7.5 mg, 10 mg, and 15 mg
OPANA ER (NDA 201655)
Oxymorphone Hydrochloride
Extended-release Tablets
20 mg, 30 mg, 40 mg
OPANA ER (NDA 201655)
180-Day Exclusivity Tracker
Exclusivity Decision
Exclusivity Granted (Pre-MMA) (Expiration 10/2/2005)
Exclusivity Granted (Pre-MMA) (Expiration 11/20/2005)
Exclusivity Granted (Expiration 3/16/2008)
Exclusivity Granted (Expiration 4/21/2012)
Exclusivity Granted (Expiration 4/21/2012)
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))
Exclusivity Forfeited (Patent Expiration - FDC Act § 505(j)(5)(D)(i)(VI))
Exclusivity Granted (Pre-MMA; Shared Exclusivity) (Expiration 1/21/2009; 40 mg)
Exclusivity Relinquished (Pre-MMA; Shared Exclusivity) (10 mg, 20 mg)
Exclusivity Decision
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
See ANDA No. 75-410
FDA Letter Decision
Exclusivity Granted (Expiration 12/28/2010)
Exclusivity Granted (Suitability Petition) (Expiration 6/7/2010) Suitability Petition - Docket No. 2004P-0373)
Exclusivity Granted (Expiration 6/25/2007)
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (Shared)
Exclusivity Granted (Shared)
Exclusivity Granted (Pre-MMA) (Expiration 6/24/2007)
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)
Exclusivity Granted (Shared)
Exclusivity Granted (Shared)
No Exclusivity Granted (Presumably Forfeited)
Exclusivity Granted (Shared) (Expiration 4/6/2008)
Exclusivity Granted (Shared) (Expiration 4/6/2008)
Exclusivity Granted (Shared) (Expiration 4/6/2008)
Exclusivity Granted (Shared) (Expiration 4/6/2008)
Exclusivity Granted (Shared) (Expiration4/6/2008)
Exclusivity Granted (Shared) (Expiration 4/6/2008)
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Expiration 5/9/2007; 5 mg)
Exclusivity Granted (Pre-MMA) (Expiration 5/9/2007; 10 mg)
Exclusivity Granted (Pre-MMA) (Expiration 5/9/2007; 15 mg)
Exclusivity Granted (Pre-MMA) (Expiration 9/26/2004; 80 mg)
Exclusivity Granted (Pre-MMA) (Expiration 12/4/2005; 10 mg, 20 mg, and 40 mg)
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (Expiration 7/7/2013)
Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Paclitaxel Injection TAXOL 1/25/2002
Injection ALOXI 5/27/2011
Pamidronate Disodium For Injection AREDIA 4/30/2001
Pamidronate Disodium Injection AREDIA 6/27/2002
Pantoprazole Sodium For Injection 40 mg/vial PROTONIX IV 4/7/2005
Pantoprazole Sodium PROTONIX 2/2/2004
8/2/2007
9/10/2007
Paricalcitol Injection ZEMPLAR 11/28/2008 7/27/2011
Date of Submission
ANDA Approval Date
Approval Letter
6 mg/mL, 5 mL, 16.7 mL, 25 mL, 33.3 mL and 50 mL vials
Prior to 12/8/2003
ANDA No. 075184
Palonosetron Hydrochloride
0.05 mg/mL, 1.5 mL and 5 mL vials
30 mg/vial, 60 mg/vial and 90 mg/vial
Prior to 12/8/2003
ANDA No. 075290
30 mg/vial, 60 mg/vial and 90 mg/vial
Prior to 12/8/2003
ANDA No. 075841
Delayed-release Tablets
20 mg and 40 mg
ANDA No. 077056
ANDA No. 077058
0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials
ANDA No. 091108
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Paricalcitol Capsules ZEMPLAR 10/14/2008
Paricalcitol Capsules 4 mcg ZEMPLAR 8/25/2008
Capsules PAXIL
Oral Suspension 10 mg/5 mL PAXIL 2/10/2005 12/4/2006
Tablets PAXIL 7/30/2003
PAXIL CR 9/9/2005 6/29/2007
37.5 mg PAXIL CR 5/19/2009 4/14/2011
Pemetrexed Disodium For Injection 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 PERMAX 11/27/2002
Perindopril Erbumine Tablets ACEON 6/6/2006
Tablets ACTOS
8/17/2012
1 mcg and 2 mcg
Paroxetine Hydrochloride 10 mg and 20 mg
Prior to 12/8/2003
Paroxetine Hydrochloride ANDA No.
077395
Paroxetine Hydrochloride 10 mg, 20 mg, 30 mg and 40 mg
Prior to 12/8/2003
ANDA No. 075356
Paroxetine Hydrochloride
Extended-release Tablets
12.5 mg and 25 mg
ANDA No. 077873
Paroxetine Hydrochloride Extended-release Tablets
ANDA No. 091427
0.05 mg, 0.25 mg and 1 mg
Prior to 12/8/2003
ANDA No. 076061
2 mg, 4 mg and 8 mg
Pioglitazone Hydrochloride
15 mg, 30 mg and 45 mg
Prior to 12/8/2003
ANDA No. 076801
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
LetterTablets ACTOS
Tablets DUETACT 12/22/2009 1/4/2013
ACTOPLUS MET XR 9/23/2011
Tablets ACTOPLUS MET 3/6/2008
For Injection ZOSYN 9/15/2009
For Injection 40.5 g/vial ZOSYN 9/15/2009
For Injection ZOSYN 12/6/2011
17g/Scoopful MIRALAX
7/30/2010
Pioglitazone Hydrochloride
15 mg, 30 mg and 45 mg
Prior to 12/8/2003
ANDA No. 076800
Pioglitazone Hydrochloride and Glimepiride
30 mg/2 mg and 30 mg/4 mg
ANDA No. 201049
Pioglitazone Hydrochloride and Metformin Hydrochloride
Extended-release Tablets
15 mg/1000 mg and 30 mg/1000 mg
Pioglitazone Hydrochloride and Metformin Hydrochloride
15 mg/500 mg and 15 mg/850 mg
6/26/2012 (Initially approved
on 2/25/2011)
ANDA No. 090406
Piperacillin Sodium and Tazobactam Sodium
2.25 g/vial, 3.375 g/vial, 4.5 g/vial
PIV received prior to
2/5/2009ANDA No. 065386
Piperacillin Sodium and Tazobactam Sodium
PIV received prior to
2/5/2009ANDA No. 065446
Piperacillin Sodium and Tazobactam Sodium
12 g/1.5 g per vial (pharmacy bulk)
Polyethylene Glycol 3350 Powder for Oral Solution
Prior to 12/8/2003
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl
For Oral Solution and Delayed-release Tablet
210 g, 5.6 g, 0.74 g, 2.86 g and 5 mg (1 Tablet Regimen)
HALFLYTELY AND BISACODYL
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
1/28/2008
For Oral Solution MOVIPREP 11/27/2007
Posaconazole Oral Suspension 40 mg/mL NOXAFIL 2/28/2011
Potassium Chloride MICRO K
Potassium Chloride K-DUR 11/20/1998
Potassium Chloride 15 mEq K-DUR 6/6/2003
Tablets MIRAPEX 6/24/2005 2/19/2008
Tablets 0.25 mg MIRAPEX 5/27/2005 2/19/2008
Tablets 0.75 mg MIRAPEX 7/31/2008 4/9/2010
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl
For Oral Solution and Delayed-release Tablets
210 g, 5.6 g, 0.74 g, 2.86 g and 5 mg (2 Tablet Regimen)
HALFLYTELY AND BISACODYL
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid
100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch
Extended-release Capsules
8 mEq and 10 mEq
Prior to 12/8/2003
Extended-release Tablets
10 mEq and 20 mEq
Prior to 12/8/2003
ANDA No. 074726
Extended-release Tablets
Prior to 12/8/2003
ANDA No. 074726
Pramipexole Dihydrochloride
0.125 mg, 0.5 mg, 1 mg and 1.5 mg
ANDA No. 077724
Pramipexole Dihydrochloride
ANDA No. 077724
Pramipexole Dihydrochloride
ANDA No 090764
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
MIRAPEX ER 6/1/2010
MIRAPEX ER 7/26/2011
Pravastatin Sodium Tablets PRAVACHOL
4/24/2006
4/23/2007
Pravastatin Sodium Tablets 30 mg PRAVACHOL 6/1/2005 11/21/2006
Prazosin Hydrochloride Capsules MINIPRESS
Oral Solution PEDIAPRED
6/28/2002
12/14/2000
ORAPRED 7/22/2010
Pregabalin Capsules LYRICA 12/30/2008
7/3/2012
Pramipexole Dihydrochloride
Extended-release Tablets
0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg
Pramipexole Dihydrochloride
Extended-release Tablets
2.25 mg and 3.75 mg
10 mg, 20 mg, 40 mg and 80 mg
Prior to 12/8/2003
ANDA No. 076056
ANDA No. 076445
ANDA No. 077730
1 mg, 2 mg and 5 mg
Prior to 12/8/2003
Prednisolone Sodium Phosphate
5 mg(base)/ 5 mL and 15 mg (base)/ 5 mL
Prior to 12/8/2003
ANDA No. 075099
ANDA No. 075117
Prednisolone Sodium Phosphate
Orally Disintegrating Tablets
10 mg, 15 mg and 30 mg
25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
ANDA No. 091040
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Pregabalin Capsules LYRICA 12/30/2008
7/3/2012
7/3/2012
7/3/2012
Pregabalin Oral Solution 20 mg/mL LYRICA 5/19/2010
Propafenone 325 mg RYTHMOL SR 11/7/2006
RYTHMOL SR 10/11/2006 10/18/2010
Propofol Injection DIPRIVAN 1/4/1999
INDERAL LA
25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
ANDA No. 091219
ANDA No. 091221
ANDA No. 091224
Extended-release Capsules
Propafenone Hydrochloride
Extended-release Capsules
225 mg and 425 mg
ANDA No. 078540
10 mg/mL ; 20 mL, 50 mL and 100 mL vials and 20 mL syringe
Prior to 12/8/2003
ANDA No. 075102
Propranolol Hydrochloride
Extended-release Capsules
60 mg, 80 mg, 120 mg and 160 mg
Prior to 12/8/2003
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Relinquished (Pre-MMA)
Exclusivity Forfeited
Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Expiration 4/21/2001)
Exclusivity Granted (Pre-MMA) (Expiration 5/5/2002; 30 mg/vial & 90 mg/vial)
Suitability Petition - Docket Nos. 1999P-2252 & 2000P-0091; See ANDA No. 76-153
Exclusivity Granted (Shared) (Expiration 6/18/2008)
Exclusivity Granted (Shared) (Expiration 6/18/2008)
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) 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 Granted (Expiration 11/1/2011)
Exclusivity Granted (Pre-MMA) (Expiration 5/31/2003)
Exclusivity Forfeited - Patent Expiration FDC Act § 505(j)(5)(D)(i)(VI))
Exclusivity Granted (pre-MMA) (Expiration 2/13/2013)
Exclusivity Decision
Exclusivity Granted
Exclusivity Granted (pre-MMA) - Triggered by Authorized Generic marketing
Exclusivity selectively waived - ANDA No. 202467
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
No Exclusivity Presumably Granted (Pre-MMA)
Exclusivity Presumably Granted
Tentative Approval(s) Granted, but RLD Withdrawn for Safety Reasons; No Exclusivity
Exclusivity Granted (Pre-MMA) (Expiration 2/28/2002; 20 mEq strength)
Exclusivity Granted (Pre-MMA) (Expiration 12/24/2003)
Exclusivity Granted (Expiration 7/3/2010)
Exclusivity Granted (Expiration 7/3/2010)
Exclusivity Decision
Exclusivity Granted (Shared) (all strengths)
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 Decision
No Exclusivity Granted
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 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)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Quetiapine Fumarate Tablets 25 mg SEROQUEL 8/12/2005
Quetiapine Fumarate 400 mg SEROQUEL XR 6/18/2008
Quetiapine Fumarate 150 mg SEROQUEL XR 11/17/2008
Quetiapine Fumarate Tablets SEROQUEL 2/12/2007
Quetiapine Fumarate Tablets SEROQUEL 2/21/2006
Quetiapine Fumarate SEROQUEL XR 6/12/2008
Quetiapine Fumarate 50 mg SEROQUEL XR 10/17/2008
Quinapril Hydrochloride Tablets ACCUPRIL
Tablets ACCURETIC 3/31/2004
Date of Submission
ANDA Approval Date
Approval Letter
Extended-release Tablets
Extended-release Tablets
50 mg, 150 mg and 400 mg
100 mg, 200 mg and 300 mg
Extended-release Tablets
200 mg and 300 mg
Extended-release Tablets
5 mg, 10 mg, 20 mg and 40 mg
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
10 mg/12.5 mg, 20 mg/12.5 mg and 20mg/25 mg
Prior to 12/8/2003
ANDA No. 076374
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA)
Exclusivity Forfeited (Patent Expiration - FDC Act § 505(j)(5)(D)(i)(VI))
Exclusivity Forfeited (Patent Expiration - FDC Act § 505(j)(5)(D)(i)(VI))
Exclusivity Forfeited (Patent Expiration - FDC Act § 505(j)(5)(D)(i)(VI))
Exclusivity Later Relinquished- See ANDA No. 076607
Exclusivity Granted (Pre-MMA) (Expiration 11/8/2004)
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Rabeprazole Sodium 20 mg ACIPHEX 2/21/2007
Regadenoson Injection LEXISCAN 4/10/2012
Raltegravir Tablets 400 mg ISENTRESS 10/12/2011
Tablets 60 mg EVISTA
Ramelteon Tablets 8 mg ROZEREM 7/22/2009
Ramipril Capsules ALTACE
10/24/2005
6/9/2008
Ranitidine Capsules ZANTAC 10/22/1997
Ranitidine Injection ZANTAC
Date of Submission
ANDA Approval Date
Approval Letter
Delayed-release Tablets
Prior to 12/8/2003
ANDA No. 076822
0.08 mg/mL, 5 mL vial
Raloxifene Hydrochloride Prior to
12/8/2003
1.25 mg, 2.5 mg, 5 mg and 10 mg
Prior to 12/8/2003
ANDA No. 076549
ANDA No. 077626
150 mg and 300 mg
Prior to 12/8/2003
ANDA No. 074655
25 mg/mL, 2 mL and 6 mL and 40 mL vials
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Ranitidine Oral Solution 15 mg/mL ZANTAC 2/21/2007
Ranitidine Tablets ZANTAC
6/21/1999
8/22/1997
Ranitidine Hydrochloride Tablets 150 mg 10/30/2007
Ranolazine RENEXA 5/17/2010
Rasagiline Mesylate Tablets AZILECT 5/17/2010
Repaglinide Tablets PRANDIN 2/10/2005
Tablets PRANDIMET 4/9/2009
Ribavirin Capsules 200 mg REBETOL
4/6/2004
4/6/2004
Risedronate Sodium Tablets ACTONEL 4/23/2004 10/5/2007
Risedronate Sodium Tablets 75 mg ACTONEL 9/10/2007
Prior to 12/8/2003
ANDA No. 076124
75 mg, 150 mg and 300 mg
Prior to 12/8/2003
ANDA No. 075094
ANDA No. 074023
ZANTAC 150 (NDA 21698/PRODUCT
002)
Extended-release Tablets
500 mg and 1000 mg
0.5 mg and 1 mg
0.5 mg, 1 mg and 2 mg
Repaglinide and Metformin Hydrochloride
1 mg/500 mg and 2 mg/500 mg
Prior to 12/8/2003
ANDA No. 076203
ANDA No. 076192
5 mg, 30 mg and 35 mg
ANDA No. 077132
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Risedronate Sodium Tablets 150 mg ACTONEL 8/12/2008
Risedronate Sodium 35 mg ATELVIA 7/19/2011
Tablets 12/18/2007
Risperidone Oral Solution 1 mg/mL RISPERDAL 1/30/2009
Risperidone Tablets RISPERDAL 6/30/2008
Risperidone 0.25 mg RISPERDAL 4/11/2005 4/30/2009
Risperidone RISPERDAL
Risperidone RISPERDAL 3/23/2005 4/30/2009
Ritonavir Tablets 100 mg NORVIR 12/21/2010
Rivastigmine Tartrate Capsules EXELON 4/21/2004
10/22/2007
10/22/2007
Delayed-release Tablets
Risedronate Sodium with Calcium Carbonate
35 mg; 500 mg ACTONEL WITH
CALCIUM
Prior to 12/8/2003
ANDA No. 076440
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg
Prior to 12/8/2003
ANDA No. 076228
Orally Disintegrating Tablets
ANDA No. 077494
Orally Disintegrating Tablets
0.5 mg, 1 mg and 2 mg
Likely On or After
12/8/2003
Orally Disintegrating Tablets
3 mg and 4 mg
ANDA No. 077494
1.5 mg, 3 mg, 4.5 mg and 6 mg
ANDA No. 077130
ANDA No. 077131
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Rivastigmine Tartrate Capsules EXELON 4/21/2004
1/8/2008
Rivastigmine Tartrate Oral Solution 2 mg/mL EXELON 11/5/2004
Rivastigmine EXELON PATCH 4/27/2011
Rizatriptan Benzoate Tablets MAXALT 9/2/2004 12/31/2012
Rizatriptan Benzoate MAXALT-MLT 2/17/2006 12/31/2012
Rofecoxib Tablets VIOXX
Ropinirole Hydrochloride 2 mg REQUIP XL 10/14/2008 5/17/2012
Ropinirole Hydrochloride 4 mg REQUIP XL 10/31/2008 5/17/2012
Ropinirole Hydrochloride 6 mg REQUIP XL 7/14/2009 5/17/2012
Ropinirole Hydrochloride 8 mg REQUIP XL 11/3/2008 5/17/2012
Tablets REQUIP 12/22/2004
1.5 mg, 3 mg, 4.5 mg and 6 mg
ANDA No. 077129
Transdermal System Extended-release
4.6 mg/24 hr and 9.5 mg/24 hr
5 mg and 10 mg
ANDA No. 077263
Orally Disintegrating Tablets
5 mg and 10 mg
ANDA No. 078173
12.5 mg, 25 mg and 50 mg
Prior to 12/8/2003
Extended-release Tablets
ANDA No. 090869
Extended-release Tablets
ANDA No. 090869
Extended-release Tablets
ANDA No. 090869
Extended-release Tablets
ANDA No. 090869
Ropinirole Hydrochloride 0.25 mg, 0.5 mg, 1 mg and 2 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Ropinirole Hydrochloride Tablets REQUIP 2/4/2005
3 mg REQUIP XL 1/8/2009
12 mg REQUIP XL 2/5/2009 5/17/2012
Injection NAROPIN 11/13/2006
Rosiglitazone Maleate Tablets AVANDIA 1/25/2013
Tablets AVANDAMET 10/22/2004
Rosuvastatin Calcium Tablets CRESTOR 8/13/200
3 mg, 4 mg and 5 mg
Ropinirole Hydrochloride Extended-release Tablets
Ropinirole Hydrochloride Extended-release Tablets
ANDA No. 090869
Ropivacaine Hydrochloride
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
Prior to 12/8/2003
ANDA No. 076747
Rosiglitazone Maleate and Metformin Hydrochloride
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
180-Day Exclusivity Tracker
Exclusivity Decision
Exclusivity Granted (Pre-MMA; Shared)
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA)
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 Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Expiration 9/15/2007)
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 (Pre-MMA; Shared) (Expiration 10/3/2004)
Exclusivity Granted (Pre-MMA; Shared) (Expiration 10/3/2004)
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA)
Exclusivity Forfeited (Application Withdrawn (FDC Act § 505(j)(5)(D)(i)(II))
Exclusivity Granted (Pre-MMA) (Expiration 7/29/2009)
Exclusivity Granted (Expiration 11/28/2009)
Exclusivity Relinquished (1 mg)
Exclusivity Granted (Expiration 11/28/2009)
Exclusivity Granted (Shared) (Expiration 12/28/2010)
Exclusivity Granted (Shared) (Expiration 12/28/2010)
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Granted
No Exclusivity Granted (Forfeited)
Exclusivity Granted (Shared) (Expiration 12/28/2010)
Exclusivity Forfeited (Patent Expiration - FDC Act § 505(j)(5)(D)(i)(VI))
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))
Exclusivity Decision
No Exclusivity Granted (Forfeited)
Tentative Approval(s) Granted
Exclusivity Granted (pre-MMA)
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Forfeited (Application Withdrawn (FDC Act § 505(j)(5)(D)(i)(II))
Exclusivity Granted (Expired 6/6/2012 Upon Patent Expiration)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Sertraline Hydrochloride Oral Concentrate 20 mg/mL ZOLOFT 12/8/2003 6/30/2006
Sertraline Hydrochloride Tablets ZOLOFT 6/30/2006
Sertraline Hydrochloride Tablets ZOLOFT 11/9/2005 2/6/2007
Sevelamer Carbonate Tablets 800 mg RENVELA 12/4/2008
Sevelamer Carbonate RENVELA 12/30/2009
Tablets RENAGEL 5/22/2008
Sevoflurane Inhalation 100%, 250 mL ULTANE
7/2/2002
5/2/2007
Capsules MERIDIA 8/14/2009
Sildenafil Citrate Tablets VIAGRA 11/19/2004
Sildenafil Citrate Tablets 100 mg VIAGRA 10/25/2004
Date of Submission
ANDA Approval Date
Approval Letter
ANDA No. 076934
25 mg, 50 mg and 100 mg
Prior to 12/8/2003
ANDA No. 075719
150 mg and 200 mg
ANDA No. 077977
Powder for Oral Suspension
0.8 g/packet and 2.4 g/packet
Sevelamer Hydrochloride 400 mg and 800 mg
Prior to 12/8/2003
ANDA No. 075895
ANDA No. 077867
Sibutramine Hydrochloride
10 mg and 15 mg
25 mg and 50 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Silver Sulfadiazine Cream 1% SILVADENE
Simvastatin Tablets ZOCOR
6/23/2006
6/23/2006
Sirolimus Tablets 0.5 mg RAPAMUNE 8/25/2010
Sirolimus Tablets RAPAMUNE 12/17/2009
Tablets OSMOPREP 4/9/2008
Sodium Oxybate Oral Solution 500 mg/mL XYREM 7/8/2010
Oral Solution 11/8/2010
Solifenacin Succinate Tablets VESICARE 4/8/2009
Sitagliptin Phosphate Tablets JANUVIA 10/18/2010
Tablets JANUMET 10/18/2010
Prior to 12/8/2003
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Prior to 12/8/2003
ANDA No. 076052
ANDA No. 076285
1 mg and 2 mg
Sodium Phosphate Monobasic Monohydrate and Sodium PhosphateDibasic Anhydrous, USP
1.102 g and 0.398 g
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate
17.5 g/3.13 g/1.6 g per bottle
SUPREP BOWEL PREP KIT
5 mg and 10 mg
25 mg, 50 mg and 100 mg
Sitagliptin Phosphate and Metformin Hydrochloride
50 mg/500 mg and 50 mg/1000 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
JANUMET XR 3/16/2012
JANUMET XR 10/22/2012
Tablets JUVISYNC 6/19/2012
Tablets JUVISYNC 6/25/2012
Sumatriptan Succinate Injection IMITREX 10/25/2004
Sumatriptan Succinate Injection IMITREX 5/9/2006
Sumatriptan Succinate Tablets IMITREX
2/9/2009
2/9/2009
Sunitinib Malate Capsules SUTENT 1/26/2010
Sitagliptin Phosphate and Metformin Hydrochloride
Extended-release Capsules
50 mg/500 mg and 50 mg/1000 mg
Sitagliptin Phosphate and Metformin Hydrochloride
Extended-release Tablets
100 mg/1000 mg
Sitagliptin and Simvastatin Phosphate
100 mg/10 mg and 100 mg/40 mg
Sitagliptin and Simvastatin Phosphate
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)
25 mg, 50 mg and 100 mg
Prior to 12/8/2003
ANDA No. 076572
ANDA No. 076840
12.5 mg, 25 mg, 37.5 mg and 50 mg
180-Day Exclusivity Tracker
Exclusivity Decision
Exclusivity Presumably Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Granted (Expiration 2/3/2007)
Exclusivity Granted (Pre-MMA) (Expiration 2/6/2007)
Exclusivity Granted (Pre-MMA) (Expiration 3/22/2006)
Exclusivity Granted (Pre-MMA) (Second period)
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA) (Expiration 12/20/2006; 5 mg, 10 mg, 20 mg, and 40 mg) Petition Decision - Docket Nos. 2005P-0008 & 2005P-0046
Exclusivity Granted (Pre-MMA) (Expiration 12/20/2006; 80 mg)
Exclusivity Decision
No Exclusivity Granted (Forfeited)
No Exclusivity Granted (Forfeited)
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)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Tacrolimus Ointment 0.03% PROTOPIC 11/22/2010
Tacrolimus Ointment 0.10% PROTOPIC 9/9/2010
Tadalafil Tablets 2.5 mg x CIALIS 10/14/2008
Tadalafil Tablets CIALIS 11/21/2007
Tadalafil Tablets 20 mg ADCIRCA 10/15/2009
Tamoxifen Citrate Tablets NOLVADEX 2/20/2003
Capsules 0.4 mg FLOMAX 12/20/2004
Telmisartan Tablets MICARDIS 12/26/2006
Tablets MICARDIS HCT 12/31/2008
Tablets 80 mg/25 mg MICARDIS HCT 2/27/2009
Temazepam Capsules 7.5 mg RESTORIL 11/1/2006 9/8/2009
Date of Submission
ANDA Approval Date
Approval Letter
5 mg, 10 mg and 20 mg
10 mg and 20 mg
Prior to 12/8/2003
ANDA No. 070929
Tamsulosin Hydrochloride
20 mg, 40 mg and 80 mg
Telmisartan and Hydrochlorothiazide
80 mg/12.5 mg and 40 mg/12.5 mg
Telmisartan and Hydrochlorothiazide
ANDA No. 078581
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Temozolomide Capsules TEMODAR 3/20/2007 3/1/2010
Temozolomide Capsules TEMODAR 3/24/2008 3/1/2010
Temsirolimus Injection TORISEL 5/25/2011
Tablets 300 mg VIREAD 1/26/2010
Tablets VIREAD 5/17/2012
Terazosin Hydrochloride Capsules HYTRIN 3/30/1998
Terazosin Hydrochloride Tablets HYTRIN 12/31/1998
Tablets 250 mg LAMISIL
Terfenadine Tablets 60 mg SELDANE
Testosterone Gel 1% ANDROGEL 1/27/2006
Testosterone Gel 1% TESTIM 8/21/2008
Testosterone 1% ANDROGEL 12/19/2008
Testosterone Gel 2% ANDROGEL 4/6/2012
5 mg, 20 mg, 100 mg, and 250 mg
ANDA No. 078879
140 mg and 180 mg
ANDA No. 078879
25 mg/mL, 1.8 mL vial
Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate
150 mg, 200 mg, and 250 mg
1 mg, 2 mg, 5 mg and 10 mg
Prior to 12/8/2003
ANDA No. 074823
1 mg, 2 mg, 5 mg and 10 mg
Prior to 12/8/2003
ANDA No. 074315
Terbinafine Hydrochloride
Prior to 12/8/2003
Prior to 12/8/2003
Prior to 12/8/2003
ANDA No. 076737
Gel Metered-dose Pump
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Testosterone Gel FOTESTA 8/14/2012
Thalidomide Capsules THALOMID 12/18/2006
Thalidomide Capsules 200 mg THALOMID 9/25/2006
Tiagabine Hydrochloride Tablets GABITRIL 2/1/2005 11/4/2011
Tablets 250 mg TICLID 7/1/1999
Tigecycline For Injection 50 mg per vial TYGACIL 6/15/2009
Timolol Maleate TIMOPTIC
Capsules ZANAFLEX 8/10/2007 2/3/2012
Tobramycin Inhalation Solution 300 mg/5 mL TOBI 6/29/2009
Tolterodine Tartrate DETROL LA 7/30/2007
Tolterodine Tartrate Tablets DETROL
Topiramate Capsules 9/7/2005
4/15/2009
4/15/2009
10 mg/actuation
50 mg and 100 mg
2 mg and 4 mg
ANDA No. 077555
Ticlopidine Hydrochloride Prior to
12/8/2003ANDA No. 075089
Ophthalmic Solution 0.25% and 0.5%
Prior to 12/8/2003
Tizanidine Hydrochloride 2 mg, 4 mg and 6 mg
ANDA No. 078868
Extended-release Capsules
2 mg and 4 mg
1 mg and 2 mg Likely On or
After 12/8/2003
ANDA No. 076953
15 mg and 25 mg
TOPAMAX SPRINKLE
ANDA No. 076448
ANDA No. 077868
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Topiramate Capsules 9/7/2005
4/15/2009
Topiramate Tablets TOPAMAX 12/26/2001
Topiramate Tablets 50 mg TOPAMAX 9/8/2005
Torsemide Tablets DEMADEX 5/14/2002
Tramadol Hydrochloride Tablets 50 mg ULTRAM
Tramadol Hydrochloride 100 mg ULTRAM ER 1/8/2007 11/13/2009
Tramadol Hydrochloride 200 mg ULTRAM ER 3/28/2007 11/13/2009
Tramadol Hydrochloride 300 mg ULTRAM ER 9/25/2007
Tramadol Hydrochloride RYZOLT 6/18/2009 12/30/2011
Trandolapril Tablets MAVIK 10/4/2004
15 mg and 25 mg
TOPAMAX SPRINKLE
ANDA No. 077868
25 mg, 100 mg and 200 mg
9/11/2006 (Converted to a
Tentative Approval on
7/27/2007 and Back to final Approval on 3/27/2009)
ANDA No. 076314
5 mg, 10 mg, 20 mg, and 100 mg
Prior to 12/8/2003
ANDA No. 076110
Prior to 12/8/2003
Extended-release Tablets
ANDA No. 078783
Extended-release Tablets
ANDA No. 078783
Extended-release Tablets
Extended-release Tablets
100 mg, 200 mg and 300 mg
ANDA No. 091607
1 mg, 2 mg and 4 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
TARKA 11/9/2007 5/26/2010
1 mg/240 mg 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 0.0040% TRAVATAN 11/28/2008
Travoprost (Preserved) 0.0040% TRAVATAN Z 2/19/2009
Tablets 150 mg DESYREL
OLEPTRO 10/18/2010
Treprostinil Sodium Injection REMODULIN 12/2/2011
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
Trandolapril and Verapamil Hydrochloride
Extended-release Tablets
2 mg/180 mg and 2 mg/240 mg
ANDA No. 079135
Trandolapril and Verapamil Hydrochloride
Extended-release Tablets
ANDA No. 079135
Trandolapril and Verapamil Hydrochloride
Extended-release Tablets
ANDA No. 079135
ANDA No. 202093
Ophthalmic Solution
Ophthalmic Solution
Trazodone Hydrochloride Prior to
12/8/2003
Trazodone Hydrochloride Extended-release Tablets
150 mg and 300 mg
10 mg/mL, 20 mL vial
0.025%, 0.05% and 0.1%
Prior to 12/8/2003
Prior to 12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Triamcinolone Acetonide Nasal Spray NASACORT AQ 12/29/2005 7/30/2009
Tablets MAXZIDE
Trospium Chloride 60 mg SANCTURA XR 3/2/2009 10/12/2012
0.055 mg/Spray
ANDA No. 078104
Triamterene/ Hydrochlorothiazide
37.5 mg/25 mg and 75 mg/50 mg
Prior to 12/8/2003
Extended-release Capsules
ANDA No. 091289
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Tentative Approval(s) Granted
Exclusivity Presumably 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 Decision
Exclusivity Granted
Tentative Approval(s) Granted
Exclusivity Granted
Exclusivity Granted (Pre-MMA) (Expiration 2/9/2000)
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 Decision
Exclusivity Granted
No Exclusivity Granted (Pre-MMA)
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA) (Exclusivity Voided by Later Court Decision)
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 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
Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Forfeited)
Exclusivity Granted
Exclusivity Granted
Exclusivity Presumably Forfeited
FDA Letter Decision
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 (Expiration 6/27/2012)
Exclusivity Decision
Exclusivity Granted
Tentative Approval(s) Granted
Exclusivity Granted (Expiration 12/5/2010)
Exclusivity Granted (Expiration 3/19/2011)
Exclusivity Granted (Expiration 12/5/2010)
No Exclusivity Granted (Pre-MMA)
No Exclusivity Granted (Pre-MMA)
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)
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Tablets VALTREX 1/31/2007
For Oral Solution 50 mg/mL VALCYTE 3/21/2011
Tablets 450 mg VALCYTE 12/27/2005
Valsartan Tablets DIOVAN 12/28/2004
Tablets DIOVAN HCT 12/2/2005 9/21/2012
Tablets DIOVAN HCT 2/7/2007 9/21/2012
Tablets 2.5 mg LEVITRA 9/4/2009
Tablets LEVITRA 7/10/2009
Vardenafil Hydrochloride Tablets 20 mg LEVITRA 3/5/2009
Vardenafil Hydrochloride 10 mg STAXYN 12/22/2011
Date of Submission
ANDA Approval Date
Approval Letter
Valacyclovir Hydrochloride
500 mg and 1000 mg
Prior to 12/8/2003
ANDA No. 076588
Valganciclovir hydrochloride
Valganciclovir Hydrochloride
40 mg, 80 mg, 160 mg and 320 mg
ANDA No. 077492
Valsartan and Hydrochlorothiazide
80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg
ANDA No. 078020
Valsartan and Hydrochlorothiazide
320 mg/12.5 mg and 320 mg/25 mg
ANDA No. 078020
Vardenafil Hydrochloride
Vardenafil Hydrochloride 5 mg and 10 mg
Orally Disintegrating Tablets
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Varenicline Tartrate Tablets CHANTIX 5/10/2010
Vecuronium Bromide For Injection NORCURON
EFFEXOR XR 6/28/2010
Tablets EFFEXOR 11/3/2005 8/3/2006
EFFEXOR XR 5/3/2007
2/12/2009 8/18/2010
225 mg Venlafaxine 1/10/2011
VERELAN PM 7/20/2006
VERELAN SR
180 mg
240 mg COVERA HS
0.5 mg and 1 mg
10 mg/vial and 20 mg/vial
Prior to 12/8/2003
Venlafaxine Hydrochloride
Extended-release Capsules
37.5 mg, 75 mg and 150 mg
Prior to 12/8/2003
ANDA No. 076565
Venlafaxine Hydrochloride
25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg
ANDA No. 076690
Venlafaxine Hydrochloride
Extended-release Tablets
37.5 mg, 75 mg and 150 mg
Venlafaxine Hydrochloride
Extended-release Tablets
37.5 mg, 75 mg and 150 mg
VENLAFAXINE HYDROCHLORIDE
ANDA No. 091272
Venlafaxine hydrochloride
Extended-release Tablets
Verapamil Hydrochloride Extended-release Capsules
100 mg and 200 mg
Verapamil Hydrochloride Extended-release Capsules
120 mg, 180 mg and 240 mg
Prior to 12/8/2003
Verapamil Hydrochloride Extended-release Tablets
ISOPTIN SR (CALAN SR)
Prior to 12/8/2003
Verapamil Hydrochloride Extended-release Tablets
Likely On or After
12/8/2003
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
300 mg VERELAN PM 5/19/2006
Vincristine Sulfate Injection ONCOVIN
Voriconazole For Injection 200 mg/vial VFEND 9/12/2008
Voriconazole Tablets VFEND 4/14/2008 4/22/2010
Voriconazole Oral Suspension 40 mg/mL VFEND 10/8/2010
Verapamil Hydrochloride Extended-release Capsules
1 mg/mL, 1 mL, 2 mL and 5 mL vials
Prior to 12/8/2003
50 mg and 200 mg
ANDA No. 090547
180-Day Exclusivity Tracker
Exclusivity Decision
Tentative Approval(s) Granted
Exclusivity Granted (Pre-MMA) (Expiration 5/24/2010)
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)
Exclusivity Granted (Expiration 3/20/2013)
Exclusivity Decision
Tentative Approval(s) Granted
No Exclusivity Granted (Forfeiture)
Exclusivity Relinquished (Pre-MMA)
Exclusivity Granted (Pre-MMA) (Expiration 12/28/2010)
Exclusivity Granted (Expiration 1/30/2007)
No Exclusivity Granted (New RLD with Approval of NDA No. 22-104 - PIV submitted 2/12/2009)
Exclusivity Granted
Exclusivity Decision
No Exclusivity Granted (Forfeiture)
Tentative Approval(s) Granted
Exclusivity Granted
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
180-Day Exclusivity Tracker
Exclusivity Decision
180-Day Exclusivity Tracker
Drug Dosage Form Strength RLD
Zafirlukast Tablets ACCOLATE 2/29/2008 11/15/2010
Zaleplon Capsules SONATA 6/21/2005
Zidovudine Capsules 100 mg RETROVIR
Capsules GEODON 2/7/2005
3/2/2012
3/2/2012
3/2/2012
Zoledronic Acid Injection RECLAST 8/29/2008
Zoledronic Acid Injection ZOMETA 6/11/2008
Zoledronic Acid Injection ZOMETA 1/31/2012
Zolpidem Tartrate Sublingual Tablets EDLUAR 4/29/2010
Date of Submission
ANDA Approval Date
Approval Letter
10 mg and 20 mg
ANDA No. 090372
5 mg and 10 mg
Ziprasidone Hydrochloride
20 mg, 40 mg, 60 mg and 80 mg
ANDA No. 077560
ANDA No. 077561
ANDA No. 077565
0.05 mg/mL, 100 mL vial
0.8 mg (base) /mL
4 mg/100 mg, 100 mL vial
5 mg and 10 mg
Drug Dosage Form Strength RLDDate of
SubmissionANDA Approval
DateApproval
Letter
Zolpidem Tartrate 6.25 mg AMBIEN CR 2/24/2006 10/13/2010
Zolpidem Tartrate 12.5 mg AMBIEN CR 1/19/2006 12/3/2010
Zolpidem Tartrate Sublingual Tablets INTERMEZZO 4/10/2012
Extended-release Tablets
ANDA No. 078179
Extended-release Tablets
ANDA No. 078148
1.75 mg and 3.5 mg
180-Day Exclusivity Tracker
Exclusivity Decision
Exclusivity Granted
No Exclusivity Granted (Forfeiture)
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)