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ANDA Approvals

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
10/3/2017 DDAVP Desmopressin Acetate Ferring Zydus Pharms
10/3/2017 Copaxone Glatiramer Acetate Teva Mylan
10/3/2017 Toviaz Fesoterodine Fumarate Pfizer Zydus Pharms
10/3/2017 Copaxone Glatiramer Acetate Teva Mylan
10/3/2017 Micardis Telmisartan Boehringer Ingelheim Micro Labs
10/4/2017 Avodart Dutasteride GlaxoSmithKline Zydus Pharms
10/4/2017 Vigamox Moxifloxacin HCl Novartis Aurobindo
10/5/2017 Effexor XR Venlafaxine HCl Wyeth MacLeods
10/5/2017 Corgard Nadolol US Worldmeds Lupin
10/6/2017 Actos Pioglitazone HCl Takeda Puracap Pharm
10/6/2017 Viramune XR Nevirapine Boehringer Ingelheim MacLeods
10/6/2017 Acticlate Doxycyline Hyclate Aqua Pharms Amneal
10/10/2017 Nuedexta Dextromethorphan Hydrobromide / Quinidine Sulfate Avanir Pharms Actavis
10/10/2017 Cleocin Clindamycin Phosphate Pharmacia and Upjohn Mylan
10/10/2017 Cleocin Clindamycin Phosphate Pharmacia and Upjohn Mylan
10/10/2017 Baraclude Entecavir Bristol Myers Squibb Prinston
10/11/2017 Pristiq Desvenlafaxine Succinate Wyeth Zydus Pharms
10/11/2017 Mepron Atovaquone GlaxoSmithKline Apotex
10/12/2017 Emend Aprepitant Merck Glenmark
10/12/2017 Zyloprim Allopurinol Casper Pharma Zydus Pharms
10/13/2017 Gabitril Tiagabine HCl Cephalon Wilshire Pharms
10/13/2017 Avodart Dutasteride GlaxoSmithKline Haupt Pharma
10/13/2017 Tobi Tobramycin Novartis Mylan
10/16/2017 Nitrostat Nitroglycerin Pfizer Actavis
10/16/2017 Effient Prasugrel Eli Lilly and Co Liberty Pharma
10/16/2017 Effient Prasugrel Eli Lilly and Co Aurobindo
10/16/2017 Effient Prasugrel Eli Lilly and Co Panacea Biotec
10/16/2017 Zemplar Paricalcitol AbbVie Akorn
10/16/2017 Gastrocrom Cromolyn Sodium Mylan Ailex Pharms
10/16/2017 Nexium 24Hr (OTC) Esomeprazole Magnesium (OTC) AstraZeneca Aurobindo
10/16/2017 Aczone Dapsone Allergan Taro
10/17/2017 Ancobon Flucytosine Valeant West-Ward
10/18/2017 Bumex Bumetanide Validus Pharms Amneal
10/20/2017 Lodosyn Carbidopa Aton Novel Labs
10/20/2017 Prometrium Progesterone Virtus Pharms Sandoz
10/20/2017 Nexium Esomeprazole Magnesium AstraZeneca Alkem Labs
10/23/2017 Renvela Sevelamer Carbonate  Genzyme Impax Labs 
10/23/2017 Kapvay Clonidine HCl Concordia Pharms Lupin
10/23/2017 Klor-Con Potassium Chloride Pharma Res Software Upsher-Smith Labs
10/25/2017 Coreg CR Carvedilol Phosphate SmithKline Beecham Sun Pharm Industries
10/25/2017 Nexterone Amiodarone HCl Baxter Healthcare Aurobindo
10/25/2017 Levetiracetam in Sodium Chloride Levetiracetam in Sodium Chloride HQ Specialty Pharma Gland Pharma
10/26/2017 Neurontin Gabapentin Pfizer Jiangsu Hengrui Med
10/26/2017 Renvela Sevelamer Carbonate Genzyme Invagen Pharms
10/26/2017 Neurontin Gabapentin Pfizer CSPC Ouyi Pharm
10/27/2017 Reclast Zoledronic Acid Novartis Mylan
10/27/2017 Methadone HCl Methadone HCl Mylan Akorn
10/27/2017 Clobex Clobetasol Propionate Galderma Labs Hi-Tech Pharmacal
10/27/2017 Zometa Zoledronic Acid Novartis Cipla 
10/27/2017 Dilaudid Hydromorphone HCl Rhodes Ascent Pharms
10/30/2017 Azilect Rasagiline Mesylate Teva Alkem Labs
10/30/2017 Xylocaine Lidocaine HCl Fresenius Kabi USA Aurobindo
10/30/2017 Allegra-D Fexofenadine HCl / Pseudoephedrine HCl (OTC) Sanofi Aventis Aurobindo
10/31/2017 Acetadote Acetylcysteine Cumberland Pharms Sagent Pharms
10/31/2017 Glucophage Metformin HCl Bristol Myers Squibb MacLeods
10/31/2017 Dexedrine Dextroamphetamine Sulfate Impax Labs Vintage Pharms
10/31/2017 Boniva Ibandronate Sodium Hoffmann La Roche MacLeods
10/31/2017 Tamiflu Oseltamivir Phosphate Roche Alvogen Pine Brook
11/2/2017 Zemplar Paricalcitol AbbVie Mylan 
11/2/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Micro Labs
11/3/2017 Wellbutrin XL Bupropion HCl Valeant TWi
11/6/2017 Hyzaar Losartan Potassium / Hydrochlorothiazide Merck Sharp Dohme Prinston
11/6/2017 Clolar Clofarabine Genzyme Dr Reddys Labs
11/6/2017 Integrilin Eptifibatide Schering Accord Healthcare
11/6/2017 Clolar Clofarabine Genzyme Amneal
11/6/2017 Clolar Clofarabine Genzyme Mylan
11/6/2017 Micardis HCT Telmisartan / Hydrochlorothiazide Boehringer Ingelheim Prinston
11/8/2017 Motrin IB (OTC) Ibuprofen (OTC) Johnson and Johnson Aurobindo
11/9/2017 Vigamox Moxifloxacin HCl Novartis Akorn
11/9/2017 Cosmegen Dactinomycin Recordati Rare Mylan
11/9/2017 Diprolene Betamethasone Dipropionate Merck Sharp Dohme Teligent Pharma
11/9/2017 Children's Allegra Fexofenadine HCl Sanofi Aventis Taro Pharm
11/9/2017 Children's Allegra Fexofenadine HCl Sanofi Aventis Taro Pharm
11/9/2017 Oxycodone HCl Oxycodone HCl Lehigh Valley / Vistapharm Ascent Pharms
11/13/2017 Cellcept Mycophenolate Mofetil Roche Palo Zhejiang Hisun Pharm
11/13/2017 Zovirax Acyclovir Valeant G and W Labs
11/13/2017 Zocor Simvastatin Merck Sharp Dohme Hisun Pharm Hangzhou
11/13/2017 Zantac 150 (OTC) Ranitidine HCl (OTC) Sanofi Aurobindo
11/13/2017 Zantac 75 (OTC) Ranitidine HCl (OTC) Sanofi Aurobindo
11/14/2017 Eloxatin Oxaliplatin Sanofi Aventis / Teva Mylan
11/16/2017 Solodyn Minocycline HCl Medicis Zydus Pharms
11/16/2017 Cellcept Mycophenolate Mofetil Roche Palo Zhejiang Hisun Pharm
11/16/2017 Lotrimin Ultra (OTC) Butenafine HCl (OTC) Bayer Healthcare Taro
11/16/2017 Intuniv Guanfacine HCl Shire Sun Pharm Inds
11/16/2017 Pulmicort Budesonide AstraZeneca Cipla 
11/16/2017 Dacogen Decitabine Otsuka Cipla 
11/16/2017 Fluoxetine HCl Fluoxetine HCl Alvogen Par
11/17/2017 Cytovene Ganciclovir Roche Palo Mylan
11/17/2017 Loestrin 24 Fe Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Apil Glenmark
11/17/2017 Abstral Fentanyl Citrate Sentynl Theraps Actavis
11/17/2017 Edecrin Ethacrynate Sodium Aton Zydus Pharms
11/20/2017 Choline C-11 Choline C-11 MCPRF UCSF Rodiopharm
11/20/2017 Busulfex Myleran Otsuka Aspen Global
11/20/2017 Focalin Dexmethylphenidate HCl Novartis Rhodes
11/20/2017 Kapvay Clonidine HCl Concordia Pharms Ajanta
11/20/2017 Fluoxetine HCl Fluoxetine HCl Alvogen Inventia Healthcare
11/20/2017 Kapvay Clonidine HCl Concordia Pharms Xiamen LP Pharm
11/20/2017 Kapvay Clonidine HCl Concordia Pharms Amneal
11/21/2017 Ziagen Abacavir Sulfate VIIV Healthcare Cipla
11/21/2017 Prezista Darunavir Ethanolate Janssen Teva
11/21/2017 Loestrin Fe 1/20 Hailey Fe 1/20 Apil Glenmark
11/21/2017 Vytorin Ezetimibe and Simvastatin Merck Sharp Dohme Amneal
11/21/2017 Locoid Hydrocortisone Butyrate Precision Dermat Teligent Pharma
11/21/2017 Avodart Dutasteride GlaxoSmithKline Humanwell Puracap
11/22/2017 Angiomax Bivalirudin The Medicines Co Accord Healthcare
11/22/2017 Crestor Rosuvastatin Calcium IPR MSN Labs
11/24/2017 Robaxin Methocarbamol West-Ward Navinta
11/24/2017 Topotecan HCl Topotecan Hydrochloride Hospira  Mylan
11/24/2017 Trokendi XR Topiramate Supernus Pharms Zydus Pharms
11/24/2017 Bacteriostatic Water for Injection in Plastic Container / Sterile Water for Injection in Plastic Container Bacteriostatic Water for Injection in Plastic Container / Sterile Water for Injection in Plastic Container Hospira / B Braun & Baxter Healthcare & Hospira & ICU Medical  Fresenius Kabi USA
11/27/2017 Capastat Sulfate Capreomycin Sulfate Akorn Mylan
11/27/2017 Atacand HCT Candesartan Cilexetil and Hydrochlorothiazide AstraZeneca Zydus Pharms
11/27/2017 Xeloda Capecitabine Hoffmann La Roche Alkem Labs
11/27/2017 Biltricide Praziquantel Bayer Healthcare Par
11/28/2017 Depo-Provera Medroxyprogesterone Acetate Pharmacia and Upjohn Amphastar Pharms
11/28/2017 Depo-Provera Medroxyprogesterone Acetate Pharmacia and Upjohn Amphastar Pharms
11/28/2017 Precedex Dexmedetomidine Hydrochloride Hospira Teva
11/28/2017 Renvela Sevelamer Carbonate Genzyme Amneal
11/29/2017 Seroquel XR Quetiapine Fumarate AstraZeneca MacLeods
11/29/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Accord Healthcare
11/29/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Aurobindo
11/29/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Novast Labs
11/29/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Sciegen Pharms
11/30/2017 Remodulin Treprostinil United Therap Sandoz
11/30/2017 Zantac 150 / Zantac 300 Ranitidine Hydrochloride Glaxo Grp Acic Pharms
11/30/2017 Heparin Sodium Heparin Sodium Fresenius Kabi USA & West-Ward Mylan
11/30/2017 Heparin Sodium Heparin Sodium Fresenius Kabi USA Mylan
11/30/2017 Prograf Tacrolimus Astellas Belcher Pharms
12/1/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Anchen Pharms
12/1/2017 Megace ES Megestrol Acetate Endo Breckenridge
12/1/2017 Advil Cold and Sinus (OTC) Ibuprofen and Pseudoephedrine Hydrochloride (OTC) Pfizer Aurobindo
12/4/2017 Abilify Aripiprazole Otsuka Prinston
12/5/2017 Pataday Olopatadine Hydrochloride Novartis Apotex
12/5/2017 Pataday Olopatadine Hydrochloride Novartis Akorn
12/5/2017 Pataday Olopatadine Hydrochloride Novartis Cipla
12/6/2017 Zyvox Linezolid Pharmacia and Upjohn Mylan
12/6/2017 Gemcitabine HCl Gemcitabine HCl Hospira Mylan
12/6/2017 Magnesium Sulfate in Plastic Container Magnesium Sulfate in Plastic Container Hospira HQ Specialty Pharma
12/6/2017 Diclegis Doxylamine Succinate and Pyridoxine Hydrochloride Duchesnay Par
12/6/2017 Clozaril Clozapine Heritage Life Zydus Pharms
12/6/2017 Clolar Clofarabine Genzyme MSN Labs
12/8/2017 Melphalan HCl Melphalan HCl Dr Reddys Labs Dr Reddys Labs
12/8/2017 Locoid Lipocream Hydrocortisone Butyrate Precision Dermat Actavis
12/8/2017 Busulfex Busulfan Otsuka Actavis
12/8/2017 Cytovene Ganciclovir Sodium Roche Palo Pharmascience
12/8/2017 Enablex Darifenacin Hydrobromide Apil Alembic
12/8/2017 Gabitril Tiagabine Hydrochloride Cephalon Amneal
12/8/2017 Reclast Zoledronic Acid Novartis Aurobindo
12/11/2017 Kenalog-40 Triamcinolone Acetonide Apothecon Amneal
12/12/2017 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Zydus Pharms
12/12/2017 Macrodantin Nitrofurantoin Alvogen Malta Zydus Pharms
12/12/2017 Safyral Tydemy Bayer Healthcare Lupin
12/12/2017 Detrol LA Tolterodine Tartrate Pharmacia and Upjohn Hetero Labs
12/12/2017 Valcyte Valganciclovir Hydrochloride Hoffmann La Roche Dr Reddys Labs
12/12/2017 Flagyl Metronidazole GD Searle Cadila Pharms
12/14/2017 Cafcit Caffeine Citrate West-Ward Micro Labs
12/14/2017 Inapsine Droperidol Akorn Eurohealth Intl
12/15/2017 Sustiva Efavirenz Bristol Myers Squibb Aurobindo
12/15/2017 Duac Clindamycin Phosphate / Benzoyl Peroxide Stiefel Taro
12/15/2017 Astepro Azelastine HCl Mylan Amneal
12/18/2017 Mesnex Mesna Baxter Healthcare Gland Pharma
12/18/2017 Xenazine Tetrabenazine Valeant Bionpharma
12/18/2017 Busulfex Busulfan Otsuka Amneal
12/19/2017 Exforge HCT Amlodipine Besylate / Valsartan / Hydrochlorothiazide Novartis Aurobindo
12/19/2017 Procardia XL Nifedipine Pfizer Zydus Pharms
12/21/2017 Advil Liqui-Gels Ibuprofen (OTC) Pfizer Ascent Pharms
12/21/2017 Zetia Ezetimibe Merck Sharp Dohme Alkem Labs
12/22/2017 Melphalan HCl Melphalan HCl Dr Reddys Labs Fresenius Kabi USA
12/22/2017 Ativan Lorazepam Valeant Intl Aurolife Pharma
12/22/2017 Avage / Tazorac Tazarotene Allergan G and W Labs
12/22/2017 Vytorin Ezetimibe / Simvastatin Merck Sharp Dohme Alkem Labs
12/22/2017 Zyrtec Cetirizine HCl Johnson and Johnson Granules India
12/22/2017 Yaz Drospirenone / Ethinyl Estradiol Bayer Healthcare Cyndea Pharma
12/22/2017 Methotrexate Sodium Methotrexate Sodium Dava Pharms Amneal
12/26/2017 Fortamet Metformin HCl Andrx Labs Nostrum Labs
12/26/2017 Norpramin Desipramine HCl US Pharm Holdings Ingenus Pharms
12/26/2017 Arixtra Fondaparinux Sodium Mylan Aurobindo
12/26/2017 Triamcinolone Acetonide Triamcinolone Acetonide Mylan Alkem Labs
12/26/2017 Synalar Fluocinolone Acetonide Medimetriks Pharms Glasshouse Pharms
12/26/2017 Minastrin 24 Fe Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Apil Glenmark
12/27/2017 Seasonique Jaimiess Teva Labs Leon Farma
12/27/2017 Anafranil Clomipramine HCl Mallinckrodt Zydus Pharms
12/29/2017 Valtrex Valacyclovir HCl GlaxoSmithKline Zydus Pharms
12/29/2017 Feldene / Piroxicam Piroxicam Pfizer / Micro Labs Micro Labs
12/29/2017 Zometa Zoledronic Acid Novartis BPI Labs
12/29/2017 Mucinex D (OTC) Guaifenesin, Pseudoephedrine HCl (OTC) Reckitt Benckiser Dr Reddys Labs

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