ANDA Approvals

Fall 2016

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
7/5/2016 Hydrocodone Bitartrate / Acetaminophen Hydrocodone Bitartrate / Acetaminophen Mikart Par
7/5/2016 Hiprex Methenamine Hippurate US Pharm Holdings Aurobindo
7/5/2016 Tobramycin Sulfate Tobramycin Sulfate Fresenius Kabi USA Claris
7/6/2016 Granisetron Hydrochloride Granisetron Hydrochloride Teva / Fresenius Kabi USA Aurobindo
7/6/2016 Starlix Nateglinide Novartis Zydus
7/6/2016 Ortho Tri-Cyclen Ethinyl Estradiol / Norgestimate Janssen Aurobindo Pharma
7/7/2016 Ortho Cyclen-28 Ethinyl Estradiol / Norgestimate Janssen Aurobindo Pharma
7/7/2016 Triamcinolone Acetonide Triamcinolone Acetonide Wockhardt Teligent Pharma
7/7/2016 Exalgo Hydromorphone Hydrochloride Mallinckrodt Osmotica
7/11/2016 Zymaxid Gatifloxacin Allergan Alcon
7/11/2016 Glucophage Metformin Hydrochloride Bristol-Myers Squibb CSPC Ouyi Pharm
7/11/2016 Norvasc Amlodipine Besylate Pfizer Polygen Pharms
7/12/2016 Tricor Fenofibrate Abbvie Hetero Labs
7/13/2016 Temodar Temozolomide Merck Sharp Dohme Amerigen
7/13/2016 Naropin Ropivacaine Hydrochloride Fresenius Kabi USA Aurobindo Pharma
7/14/2016 Xeloda Capecitabine Hoffmann LA Roche Roxane
7/14/2016 Pyridoxine Hydrochloride Pyridoxine Hydrochloride Fresenius Kabi USA Mylan
7/15/2016 Zegerid (OTC) Omeprazole / Sodium Bicarbonate (OTC) Bayer Healthcare Perrigo
7/15/2016 Zegerid (OTC) Omeprazole / Sodium Bicarbonate (OTC) Bayer Healthcare Par
7/15/2016 Zegerid (OTC) Omeprazole / Sodium Bicarbonate (OTC) Bayer Healthcare Actavis
7/15/2016 Zegerid Omeprazole / Sodium Bicarbonate Santarus Dr Reddys Labs
7/15/2016 Zegerid Omeprazole / Sodium Bicarbonate Santarus Ajanta Pharma
7/15/2016 Nilandron Nilutamide Concordia Pharms ANI Pharms
7/18/2016 Valcyte Valganciclovir Hydrochloride Hoffmann LA Roche Actavis
7/19/2016 Crestor Rosuvastatin Calcium IPR Apotex
7/19/2016 Crestor Rosuvastatin Calcium IPR Mylan
7/19/2016 Crestor Rosuvastatin Calcium IPR Teva
7/19/2016 Crestor Rosuvastatin Calcium IPR Par
7/19/2016 Crestor Rosuvastatin Calcium IPR Sun Pharma
7/19/2016 Crestor Rosuvastatin Calcium IPR Aurobindo Pharma
7/19/2016 Crestor Rosuvastatin Calcium IPR Sandoz
7/19/2016 Crestor Rosuvastatin Calcium IPR Glenmark
7/21/2016 Avalide Irbesartan / Hydrochlorothiazide Sanofi Aventis Mylan
7/22/2016 Triamcinolone Acetonide Triamcinolone Acetonide Perrigo Glenmark
7/25/2016 Marcaine Bupivacaine Hydrochloride Hospira Claris
7/26/2016 Prevacid Lansoprazole Takeda Anchen Pharms
7/27/2016 Phoslo Gelcaps Calcium Acetate Fresenius Lotus Pharm
7/27/2016 Klor-Con M20 Potassium Chloride Upsher Smith Labs Glenmark
7/27/2016 Zegerid Omeprazole / Sodium Bicarbonate Santarus Ajanta Pharma
7/28/2016 Zyloprim Allopurinol Sebela Ireland Indoco Remedies
7/28/2016 Metadate CD Methylphenidate Hydrocholoride UCB Corepharma
7/29/2016 Pristiq Desvenlafaxine Succinate Wyeth Actavis
8/1/2016 Edluar Zolpidem Tartrate Meda Par
8/1/2016 Glumetza Metformin Hydrochloride Santarus Sun Pharma
8/1/2016 Glumetza Metformin Hydrochloride Santarus Actavis
8/3/2016 Tamiflu Oseltamivir Phosphate Roche Natco Pharma
8/3/2016 Cymbalta Duloxetine Hydrochloride Lilly Hetero Labs
8/4/2016 Gleevec Imatinib Mesylate Novartis Teva
8/4/2016 Zyvox Linezolid Pharmacia and Upjohn Aurobindo Pharma
8/5/2016 Gleevec Imatinib Mesylate Novartis Apotex
8/5/2016
Buprenorphine Hydrochloride
/ Naloxone Hydrochloride
Buprenorphine Hydrochloride /
Naloxone Hydrochloride
Actavis Sun Pharm
8/5/2016 Razadyne ER Galantamine Hydrobromide Janssen Aurobindo Pharma
8/5/2016 Triamcinolone Acetonide Triamcinolone Acetonide Fougera Pharms Glenmark
8/8/2016 Edluar Zolpidem Tartrate Meda Pharms Mylan
8/8/2016 Vfend Voriconazole PF Prism Prinston
8/9/2016 Klor-Con Potassium Chloride Upsher-Smith Labs Novel Labs
8/10/2016 Nexium IV Esomeprazole Sodium AstraZeneca Aurobindo Pharma
8/11/2016 Triamcinolone Acetonide Triamcinolone Acetonide Taro Versapharm
8/12/2016 Topicort Desoximetasone Taro Groupe Parima
8/15/2016 Potassium Chloride Potassium Chloride Actavis Novel Labs
8/15/2016 Cetirizine Hydrochloride Allergy Cetirizine Hydrochloride Allergy (OTC) Bionpharma Apotex
8/17/2016 Zemplar Paricalcitol Abbvie Dr Reddys Labs
8/17/2016 Zyban Bupropion Hydrochloride GlaxoSmithKline Sciegen Pharms
8/18/2016 Reclast Zoledronic Acid Novartis Gland Pharma
8/19/2016 Sarafem Fluoxetine Hydrochloride Mylan / Apil Par
8/19/2016 Felodipine Felodipine Mylan Jubilant Generics
8/19/2016 Zegerid Omeprazole / Sodium Bicarbonate Santarus Aurolife Pharma
8/19/2016 Diclegis
Doxylamine Succinate / 
Pyridoxine Hydrochloride
Duchesnay Actavis
8/19/2016 Wellbutrin Bupropion Hydrochloride GlaxoSmithKline Heritage Pharma
8/19/2016 Klor-Con Potassium Chloride Upsher-Smith Labs Sigmapharm Labs
8/22/2016 Micardis Telmisartan Boehringer Ingelheim Jubilent Generics
8/22/2016 Alkeran Melphalan Hydrochloride Apotex Par
8/22/2016 Zyvox Linezolid Pharmacia and Upjohn Novel Labs
8/23/2016 Trospium Chloride Trospium Chloride Glenmark Generics Invagen Pharms
8/23/2016 Zantac 300 Ranitidine Hydrochloride Glaxo Strides Pharma
8/24/2016 Augmentin '875'
Amoxicillin / 
Clavulanate Potassium
Dr Reddys Labs Hikma Pharms
8/24/2016 Miralax (OTC) Polyethylene Glycol 3350 (OTC) Bayer Healthcare Strides Pharma
8/24/2016 Edecrin Ethacrynate Sodium Aton Mylan
8/24/2016 Paclitaxel Pacitaxel Hospira Gland Pharma
8/25/2016 Adalat CC Nifedipine Alvogen Novast Labs
8/25/2016 Duac
Clindamycin Phosphate / 
Benzoyl Peroxide
Stiefel Tolmar
8/25/2016 MS Contin Morphine Sulfate Purdue Pharma Sun Pharm
8/26/2016 Nitrostat Nitroglycerin Pfizer Pharms Dr Reddys Labs
8/30/2016 Trospium Chloride Trospium Chloride Glenmark Generics Heritage Pharms
8/30/2016 Zyprexa Olanzapine Lilly Ajanta Pharma
8/30/2016 Cordran Flurandrenolide Aqua Pharms Perrigo
9/1/2016 Enablex Darifenacin Hydrobromide Apil Cipla
9/2/2016 Levonorgestrel Levonorgestrel Perrigo Lotus Pharm
9/2/2016 Levonorgestrel (OTC) Levonorgestrel (OTC) Perrigo Lotus Pharm
9/2/2016 Levonorgestrel Levonorgestrel Perrigo Jai Pharma
9/2/2016 Levonorgestrel (OTC) Levonorgestrel (OTC) Perrigo Jai Pharma
9/2/2016 Pennsaid Diclofenac Sodium Nuvo Res Amneal
9/7/2016 Trilipix Fenofibric Acid Abbvie Impax Labs
9/7/2016 Advil Liqui-Gels (OTC) Ibuprofen (OTC) Pfizer Sofgen Pharms
9/7/2016 Vfend Voriconazole PF Prism CV Versapharm
9/8/2016 Naftin Naftifine Hydrochloride Merz Pharms Taro
9/8/2016 Feldene Piroxicam Pfizer Flamingo Pharms
9/9/2016 Hectorol Doxercalciferol Genzyme Rising Pharms
9/9/2016 Kariva Volnea Barr Sandoz
9/9/2016 Dermotic Fluocinolone Acetonide Hill Dermac Versapharm
9/9/2016 Vimpat Lacosamide UCB Amneal
9/9/2016 Lidocaine Lidocaine Fougera Glenmark
9/12/2016 Abilify Aripiprazole Otsuka Ajanta Pharma
9/13/2016 Solaraze Diclofenac Sodium Fougera Pharms Glenmark
9/15/2016 Accupril Quinapril Hydrochloride Pfizer Prinston
9/15/2016 Ritalin Methylphenidate Hydrocholoride Novartis Cnty Line Pharms
9/15/2016 Lunesta Eszopiclone Sunovion Pharms Aurobindo Pharma
9/16/2016 Keppra Levetiracetam UCB Mylan
9/16/2016 Exforge

Amlodipine Besylate / Valsartan

Novartis Invagen Pharms
9/19/2016 Aldactone Spironolactone GD Searle Accord Healthcare
9/19/2016 Buprenorphine Hydrochloride / Naloxone Hydrochloride
Buprenorphine Hydrochloride / 
Naloxone Hydrochloride
Actavis Kremers Urban Pharms
9/19/2016 Enablex Darifenacin Hydrobromide Apil Aurobindo Pharma
9/20/2016 Diovan Valsartan Novartis MacLeods Pharms
9/20/2016 Bromfed-DM
Brompheniramine Maleate/
Pseudoephedrine Hydrochloride/ 
Dextromethorphan Hydrobromide
Wockhardt Acella Pharms
9/21/2016 Argatroban Argatroban Pfizer Hospira
9/21/2016 Yasmin Drospirenone and Ethinyl Estradiol Bayer Healthcare Apotex
9/22/2016 Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine Hikma Pharmaceutics
9/23/2016 Claritin Loratadine (OTC) Bayer Healthcare Marksans Pharma
9/23/2016 Levora 0.15/30-28 Ayuna Mayne Pharma Aurobindo Pharma
9/23/2016 Nor-QD Incassia Apil Aurobindo Pharma
9/26/2016 Ziagen Abacavir Sulfate VIIV Healthcare Hetero Labs
9/26/2016 Sporanox Itraconazole Janssen Amneal
9/26/2016 Zometa Zoledronic Acid Novartis Aurobindo Pharma
9/28/2016 Namenda XR Memantine Hydrochloride Forest Labs Sun Pharma
9/28/2016 Namenda XR Memantine Hydrochloride Forest Labs Lupin
9/28/2016 Namenda XR Memantine Hydrochloride Forest Labs Mylan
9/28/2016 Synalar Fluocinolone Acetonide Medimetriks Pharms G and W Labs
9/29/2016 Epzicom Abacavir Sulfate and Lamivudine VIIV Healthcare Teva
9/29/2016 Lithobid Lithium Carbonate ANI Pharms Heritage Pharma
9/29/2016 Ability Aripiprazole Otsuka Sciegen Pharms
9/29/2016 Vidaza Azacitidine  Celgene Shilpa Medicare
9/30/2016 Diamox Acetazolamide Teva Novast Labs
9/30/2016 Betimol Timolol Oak Pharms Akorn
9/30/2016 Amantadine Hydrochloride Amantadine Hydrochloride Sandoz Newgen Pharms

Amlodipine Besylate / Valsartan

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