ANDA Approvals

Fall 2015

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
7/7/2015 Axert Almotriptan Malate Janssen Pharms Teva Pharms USA
7/7/2015 Zyvox Linezolid Pharmacia and Upjohn Hospira
7/8/2015 Soma Carisoprodol Meda Pharms Indicus Pharma
7/8/2015 Pennsaid Diclofenac Sodium Nuvo Research IGI Labs
7/8/2015 Flecainide Acetate Flecainide Acetate Roxane Aurobindo Pharma
7/9/2015 Phoslo Gelcaps Calcium Acetate Fresenius Medical Lupin
7/9/2015 Macrobid Nitrofurantoin (Monohydrate/ Macrocrystals) Alvogen Watson Labs
7/10/2015 Klor-Con Pottasium Chloride Actavis Upsher Smith
7/10/2015 Viramune XR Nevirapine Boehringer Ingelheim Alvogen Pine Brook
7/10/2015 Travatan Z Travoprost Alcon Pharms Apotex
7/13/2015 Pataday Olopatadine Hydrochloride Alcon Pharms Barr Labs
7/13/2015 Zofran Ondansetron Hydrochloride Novartis Pharms Corp Accord Healthcare
7/13/2015 Tobi Tobramycin Novartis Pharms Amneal Pharms
7/14/2015 Angiomax Bivalirudin Medicines Co Hospira
7/14/2015 Angiomax Bivalirudin Medicines Co Hospira
7/14/2015 Protonix IV Pantoprazole Sodium Wyeth Sandoz
7/15/2015 Qualaquin Quinine Sulfate Mutual Pharm Co Amneal Pharms
7/15/2015 Prandimet Repaglinide / Metformin Hydrochloride Novo Nordisk Lupin
7/16/2015 Zyvox Linezolid Pharmacia and Upjohn Sandoz
7/20/2015 Bimatoprost Bimatoprost Lupin Apotex
7/21/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron MIPS CRF
7/22/2015 Qualaquin Quinine Sulfate Mutual Pharm Co RiconPharma
7/23/2015 Norvasc Amlodipine Besylate Pfizer Sovereign Pharms
7/23/2015 Brevibloc Esmolol Hydrochloride Baxter Healthcare Aurobindo Pharma
7/24/2015 Abilify Aripiprazole Otsuka Apotex
7/24/2015 Diflorasone Diacetate Diflorasone Diacetate Taro VersaPharm
7/24/2015 Niaspan Niacin Abbvie Amneal Pharms
7/24/2015 Nimodipine Nimodipine Bannar Life Sciences Sofgen Pharms
7/27/2015 Lithobid Lithium Carbonate Ani Pharms Unique Pharm Labs
7/28/2015 Astelin Azelastine Hydrochloride Meda Pharms Breckenridge Pharms
7/28/2015 Buprenex Buprenorphine Hydrochloride Indivior Par Sterile Products
7/28/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein University of Michigan
7/28/2015 Folic Acid Folic Acid Amneal Pharm/Watson Labs Nuvo Pharm
7/29/2015 Edecrin Ethacrynate Sodium Aton Par Sterile Products
7/29/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Hot Shots NM
7/30/2015 Benzonatate Benzonatate The Pharma Network Strides Arcolab
7/30/2015 Prilosec OTC Omeprazole Magnesium Astrazeneca Perrigo
7/30/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Cardnal Health 414
7/31/2015 Benzonatate Benzonatate The Pharma Network CSPC NBP Pharm
7/31/2015 Claritin Loratadine Bayer Healhcare Taro
7/31/2015 Namenda Memantine Hydrochloride Forest Labs Upsher Smith
7/31/2015 Aciphex Rabeprazole Sodium Eisai Amneal Pharms
8/3/2015 Xanax Alprazolam Pharmacia and Upjohn Aurobindo Pharma
8/3/2015 Nexium Esomeprazole Magnesium Astrazeneca Mylan Labs
8/3/2015 Zutripro Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride Cypress Pharm Coastal Pharms
8/3/2015 Advil Ibuprofen Sodium Pfizer Consumer Healthcare Perrigo
8/3/2015 Singulair Montelukast Sodium Merck Ajanta Pharma
8/3/2015 Singulair Montelukast Sodium Merck Ajanta Pharma
8/3/2015 Singulair Montelukast Sodium Merck Ajanta Pharma
8/3/2015 Invega Paliperidone Janssen Pharms Actavis
8/4/2015 Androgel Testosterone Abbvie Perrigo Israel
8/4/2015 Tindamax Tinidazole Mission Pharma Edenbridge Pharms
8/5/2015 Zyrtec Cetirizine Hydrochloride McNeil Consumer Aurobindo Pharma
8/5/2015 Zyrtec Cetirizine Hydrochloride McNeil Consumer Aurobindo Pharma
8/5/2015 Precedex Dexmethylphenidate Hydrochloride Hospira Watson Labs
8/5/2015 Fortesta Testosterone Endo Pharms Actavis
8/7/2015 Amiloride Hydrochloride Amiloride Hydrochloride Par Pharm Zydus Pharms USA
8/7/2015 Lidocaine Lidocaine Fougera Amneal Pharms
8/7/2015 Lidoderm Lidocaine Teikoku Pharma USA Mylan Technologies
8/7/2015 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Dr. Reddy's
8/11/2015 Detrol LA Tolterodine Tartrate Pharmacia and Upjohn Torrent Pharms
8/12/2015 Kariva Bekyree Barr Lupin
8/12/2015 Ortho-Cept Isibloom Janssen Pharms Sandoz
8/12/2015 Levaquin Levofloxacin Janssen Pharms Hospira
8/12/2015 Cozaar Lorsartan Potassium Merck Sharp Dohme Hetero Labs
8/13/2015 Keppra Levetiracetam UCB Fresenius Kabi USA
8/13/2015 Atralin Tretinoin Dow Pharm Spear Pharms
8/14/2015 Ammonia N 12 Ammonia N 13 Feinstein Precision Nuclear
8/14/2015 Abilify Aripiprazole Otsuka Amneal Pharms
8/14/2015 Abilify Aripiprazole Otsuka Silarx Pharms
8/14/2015 Xylocaine Lidocaine Hydrochloride Fresenius Kabi USA Luitpold
8/14/2015 Methylin Methylphenidate Hydrochloride Mallinckrodt Novel Labs
8/17/2015 Yaz Drospirenone / Ethinyl Estradiol Bayer Healthcare Glenmark Pharms
8/17/2015 Fenofibrate Fenofibrate Teva Lupin
8/17/2015 Oxycodone Hydrochloride Oxycodone Hydrochloride Lehigh Valley Avanthi
8/17/2015 Xenazine Tetrabenazine Valeant Sun Pharma Global
8/18/2015 Cisplatin Cisplatin Fresenius Kabi USA Accord Healthcare
8/18/2015 Demeclocycline Hydrochloride Demeclocycline Hydrochloride Amneal Pharm Epic Pharma
8/18/2015 Dolophine Hydrochloride Methadone Hydrochloride Roxane Corepharma
8/18/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron IBA Molecular N Am
8/19/2015 Boniva Ibandronate Sodium Roche Lupin
8/19/2015 Prilosec Omeprazole Astrazeneca Aurobindo Pharma USA
8/20/2015 Pennsaid Diclofenac Sodium Nuvo Research Lupin
8/20/2015 Rozerem Ramelteon Takeda Pharms USA Actavis
8/21/2015 Celebrex Celecoxib GD Searle Alembic Pharms
8/24/2015 Delalutin Hydroxyprogesterone Caproate Bristol-Myers Squibb McGuff
8/24/2015 Oxycodone Hydrochloride Oxycodone Hydrochloride Lehigh Valley Novel Labs
8/24/2015 Rythmol SR Propafenone Hydrochloride GlaxoSmithKline Watson Labs
8/25/2015 Focalin XR Dexmethylphenidate Hydrochloride Novartis Mylan Pharms
8/25/2015 Prilosec Omeprazole Astrazeneca Lupin
8/26/2015 Baraclude Entecavir Bristol-Myers Squibb Aurobindo Pharma
8/26/2015 Prometh VC Promethazine Hydrochloride / Phenylephrine Hydrochloride w/Codiene Phosphate Actavis Amneal Pharms
8/28/2015 Tarceva Erlotinib Hydrochloride OSI Pharms Teva Pharms USA
8/28/2015 Lexapro Escitalopram Oxalate Forest Labs Prinston
8/28/2015 Evista Raloxifene Hydrochloride Eli Lilly Aurobindo Pharma
8/31/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein IBA Molecular N Am
8/31/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Queen Hamamatsu Pet
8/31/2015 Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide Reckitt Benckiser Actavis
8/31/2015 Dolophine Hydrochloride Methadone Hydrochloride Roxane Aurolife Pharma
8/31/2015 Avelox Moxifloxacin Hydrochloride Bayer Healthcare Mylan Pharms
8/31/2015 Detrol Tolterodine Tartrate Pharmacia and Upjohn MacLeods Pharms
9/2/2015 Zyrtec Cetirizine Hydrochloride McNeil Consumer Par Pharm
9/2/2015 Synalar Fluocinolone Acetonide Medimetriks Pharms Gavis Pharms
9/2/2015 Vfend Voriconazole PF Prism CV Glenmark Pharms
9/3/2015 Mucinex Guaifenesin Reckitt Benckiser Actavis
9/3/2015 Levaquin Levofloxacin in Dextrose 5% in Plastic Container Janssen Pharms Hospira
9/3/2015 Exelon Rivastigmine Novartis Alvogen
9/3/2015 Micardis Telmisartan Boehringer Ingelheim Aurobindo Pharma
9/4/2015 Ampicillin Sodium Ampicillin Sodium Sandoz Hospira
9/4/2015 Ampicillin Sodium Ampicillin Sodium Sandoz Hospira
9/4/2015 Topicort Desoximetasone Taro Actavis
9/4/2015 Keppra XR Levetiracetam UCB Dexcel Pharma
9/4/2015 Namenda Memantine Hydrochloride Forest Labs Wockhardt
9/4/2015 Singulair Montelukast Sodium Merck Amneal Pharms
9/8/2015 Giazo Balsalazide Disodium Valeant Par Pharm
9/8/2015 Micardis Telmisartan Boehringer Ingelheim Amneal Pharms
9/9/2015 Ortho Tri-Cyclenlo Norgestimate / Ethinyl Estradiol Janssen Pharms Jai Pharma
9/9/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Xellia Pharms
9/10/2015 Soriatane Acitretin Stiefel Labs Inc Mylan Pharms
9/8/2015 Giazo Balsalazide Disodium Valeant Par Pharm
9/8/2015 Micardis Telmisartan Boehringer Ingelheim Amneal Pharms
9/9/2015 Ortho Tri-Cyclenlo Norgestimate / Ethinyl Estradiol Janssen Pharms Jai Pharma
9/9/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Xellia Pharms
9/10/2015 Soriatane Acitretin Stiefel Labs Inc Mylan Pharms
9/11/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein MIPS CRF
9/11/2015 Lescol XL Fluvastatin Sodium Novartis Mylan Pharms
9/15/2015 Clarithromycin Clarithromycin Teva Lupin
9/15/2015 Fazaclo ODT Clozapine Jazz Pharms Mylan Pharms
9/15/2015 Ibuprofen Ibuprofen Dr Reddy's Granules India
9/15/2015 Mestinon Pyridostigmine Bromide Valeant Impax Labs
9/16/2015 Taxotere Docetaxel Sanofi Aventis Teva Pharms USA
9/16/2015 Allegra Fexofenadine Hydrochloride Sanofi Aventis Sciegen Pharms
9/16/2015 Allegra Fexofenadine Hydrochloride Sanofi Aventis Sciegen Pharms
9/16/2015 Lopid Gemfibrozil Pfizer Pharms Aurobindo Pharma
9/16/2015 Corgard Nadolol King Pharms Orion Corp
9/17/2015 Zomig-ZMT Zolmitriptan Astrazeneca Jubilant Generics
9/18/2015 Buspirone Hydrochloride Buspirone Hydrochloride Teva Emcure Pharms USA
9/18/2015 Precedex Dexmedetomidine Hydrochloride Hospira Fresenius Kabi USA
9/21/2015 Benzaclin Clindamycin Phosphate / Benzoyl Peroxide Valeant Perrigo Israel
9/21/2015 Benzamycin Erythromycin / Benzoyl Peroxide Valeant Lyne
9/21/2015 Nexium Esomeprazole Magnesium Astrazeneca Hetero Labs
9/21/2015 Testred Methyltestosterone Valeant Impax Labs
9/21/2015 Lysteda Tranexamic Acid Ferring Pharms Mylan
9/22/2015 Cafcit Caffeine Citrate Eurohealth Intl Aurobindo Pharma
9/22/2015 Ritalin Methylphenidate Hydrochloride Novartis Ascent Pharms
9/22/2015 Roxicodone Oxycodone Hydrochloride Mallinckrodt Epic Pharma
9/23/2015 Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride Ivax Sub Teva Pharms Mirror Pharms
9/24/2015 Focalin Dexmethylphenidate Hydrochloride Novartis Sun Pharm Inds
9/25/2015 Nexium Esomeprazole Magnesium Astrazeneca Dr. Reddy's
9/25/2015 Nexium Esomeprazole Sodium Astrazeneca Accord Healthcare
9/29/2015 Metadate CD Methylphenidate Hydrochloride UCB Mallinckrodt
9/30/2015 Epiduo Adapalene / Benzoyl Peroxide Galderma Labs Actavis
9/30/2015 Abilify Aripiprazole Otsuka Apotex
9/30/2015 Dexamethasone Sodium Phosphate Dexamethasone Sodium Prosphate Luitpold BD RX
9/30/2015 Zomig Zolmitriptan IPR MacLeods Pharms
9/30/2015 Zomig Zolmitriptan IPR Alembic Pharms

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