ANDA Approvals

Winter 2015

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
10/5/2015 Indomethacin Indomethacin Sandoz Jubilant Generics
10/7/2015 Trilipix Fenofibric Acid Abbvie Actavis Elizabeth
10/7/2015 Ketorolac Tromethamine Ketorolac Tromethamine Hospira BD RX
10/8/2015 Abilify Aripiprazole Otsuka Aurobindo Pharma
10/8/2015 Singulair Montelukast Sodium Merck Unichem Labs
10/13/2015 Namenda Memantine Hydrochloride Forest Labs Jubilant Generics
10/13/2015 Namenda Memantine Hydrochloride Forest Labs Unichem Labs
10/13/2015 Namenda Memantine Hydrochloride Forest Labs Torrent Pharms
10/13/2015 Namenda Memantine Hydrochloride Forest Labs Alembic Pharms
10/13/2015 Namenda Memantine Hydrochloride Forest Labs MacLeods Pharms
10/13/2015 Namenda Memantine Hydrochloride Forest Labs MacLeods Pharms
10/13/2015 Namenda Memantine Hydrochloride Forest Labs Aurobindo Pharma
10/13/2015 Namenda Memantine Hydrochloride Forest Labs Silarx Pharms
10/13/2015 Aloxi Palonosetron Hydrochloride Helsinn Healthcare Teva
10/13/2015 Aloxi Palonosetron Hydrochloride Helsinn Healthcare Sandoz
10/14/2015 Cozaar Losartan Potassium Merck Sharp & Dohme Unichem Labs
10/15/2015 Viramune XR Nevirapine Boehringer Ingelheim Cipla
10/16/2015 Maxalt T-MLT Rizatriptan Benzoate Merck Jubilant Generics
10/16/2015 Boniva Ibandronate Sodium Roche Apotex
10/16/2015 Buprenorphine Hydrochloride / Naloxone Hydrochloride Buprenorphine Hydrochloride / Naloxone Hydrochloride Actavis Elizabeth Ethypharm USA
10/19/2015 Nexium Esomeprazole Magnesium AstraZeneca Torrent Pharms
10/19/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron 3D Imaging Drug
10/19/2015 Ammonia N 13 Ammonia N 13 Feinstein 3D Imaging Drug
10/20/2015 Ampicillin Sodium Ampicillin Sodium Sandoz Sagent Pharms
10/20/2015 Intuniv Guanfacine Hydrochloride Shire Impax Labs
10/20/2015 Zyprexa Olanzapine Lilly Alkem Labs
10/20/2015 Levoleucovorin Calcum Levoleucovorin Calcium Sandoz Mylan
10/20/2015 Ultram ER Tramadol Hydrochloride Valeant Aurobindo Pharma
10/21/2015 Modicon 28 Norethindrone / Ethinyl Estradiol Janssen Pharms Jai Pharma
10/21/2015 Ortho-Novum 1/35-28 Norethindrone / Ethinyl Estradiol Janssen Pharms Jai Pharma
10/22/2015 Yaz Drospirenone / Ethinyl Estradiol Bayer Healthcare Jai Pharma
10/22/2015 Aricept Donepezil Hydrochloride Eisai Mylan
10/22/2015 Zomig-ZMT Zolmitriptan AstraZeneca MacLeods Pharms
10/23/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Triad Isotopes
10/26/2015 Phoslo Gelcaps Calcium Acetate Fresenius Medical Nostrum Labs
10/27/2015 Ortho Cyclen-28 Norgestimate / Ethinyl Estradiol Janssen Pharms Haupt Pharma
10/27/2015 Lamictal ODT Lamotrigine GlaxoSmithKline Par Pharm
10/27/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 UCLA Biomedical Kettering MedCtr
10/28/2015 Cymbalta Duloxetine Hydrochloride Lilly Anchen Pharms
10/28/2015 Blisovi 24Â FENorethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Amneal Pharms Lupin
10/28/2015 Cymbalta Duloxetine Hydrochloride Lilly Inventia Healthcare
10/29/2015 Choline C-11 Choline C-11 MCPRF Univ TX MD Anderson
10/30/2015 Aricept Donepezil Hydrochloride Eisai Lupin
10/30/2015 Lotrisone Clotrimazole / Betamethasone Dipropionate Merck Sharp & Dohme Glenmark Pharms
10/30/2015 Fiorinal w/Codeine Butalbital / Aspirin / Caffeine / Codeine Phosphate Actavis Labs UT Coastal Pharms
10/30/2015 Butapap Butalbital / Acetaminophen Mikart Tedor Pharma
10/30/2015 Micardis Telmisartan Boehringer Ingelheim Inventia Healthcare
10/30/2015 Sporanox Itraconazole Janssen Pharms Amneal Pharms
11/2/2015 Micardis HCT Telmisartan / Hydrochlorothiazide Boehringer Ingelheim MacLeods Pharms
11/3/2015 Ultane Sevoflurane Abbvie Shanghai Hengrui
11/4/2015 Felbatol Felbamate Meda Pharms Corepharma
11/5/2015 Actoplus Met Pioglitazone Hydrochloride / Metformin Hydrochloride Takeda MacLeods Pharms
11/5/2015 Singulair Montelukast Sodium Merck Anbison Lab
11/5/2015 Klor-Con Potassium Chloride Upsher-Smith Labs Paddock
11/9/2015 Viramune XR Nevirapine Boehringer Ingelheim Alvogen Malta
11/9/2015 Axert Almotriptan Malate Janssen Pharms Mylan
11/10/2015 Dextroamp Saccharate / AMP Aspartate / AMP Sulfate Dextroamp Saccharate / AMP Aspartate / AMP Sulfate Barr Mylan
11/12/2015 Ortho Tri-Cyclen Norgestimate / Ethinyl Estradiol Janssen Pharms Haupt Pharma
11/12/2015 Soma Carisoprodol Meda Pharms Shasun Pharms
11/12/2015 Baraclude Entecavir Bristol Myers Squibb Amneal Pharms
11/13/2015 NTEs Fludeoxyglucose F18 Cardinal Health 414
11/13/2015 Seasonale Levonorgestrel / Ethinyl Estradiol Teva Branded Pharm Haupt Pharma
11/13/2015 Choline C-11 Choline C-11 MCPRF Global Isotopes
11/13/2015 Ritalin Methylphenidate Hydrochloride Novartis Novel Labs
11/16/2015 Voltaren Diclofenac Sodium Novartis Altaire Pharms
11/17/2015 Desoxyn Methamphetamine Hydrochloride Recordati Rare Roxane
11/17/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Midwest Medical
11/17/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron UIHC Pet Imaging
11/17/2015 Namenda Memantine Hydrochloride Forest Labs Puracap Pharm
11/18/2015 Loestrin FE 1.5/30 Blisovi FE 1.5/30 Warner Chilcott Lupin
11/18/2015 Revatio Sildenafil Citrate Pfizer Aurobindo Pharma
11/18/2015 Aciphex Rabeprazole Sodium Eisai Breckenridge Pharm
11/19/2015 Trivora-28 Levonorgestrel / Ethinyl Estradiol Watson Labs Lupin
11/19/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Midwest Medical
11/20/2015 Avodart Dutasteride GlaxoSmithKline Banner Pharmacaps
11/20/2015 Avodart Dutasteride GlaxoSmithKline Vintage Pharms LLC
11/20/2015 Avodart Dutasteride GlaxoSmithKline Rising Pharms Inc
11/20/2015 Avodart Dutasteride GlaxoSmithKline Sandoz
11/20/2015 Avodart Dutasteride GlaxoSmithKline Actavis Labs FL
11/20/2015 Avodart Dutasteride GlaxoSmithKline Amneal Pharms
11/20/2015 Avodart Dutasteride GlaxoSmithKline Strides Arcolab
11/20/2015 Avodart Dutasteride GlaxoSmtihKline Breckenridge Pharm
11/20/2015 Jalyn Dutasteride / Tamsulosin Hydrochloride GlaxoSmithKline Actavis Labs FL
11/23/2015 Avodart Dutasteride GlaxoSmithKline Roxane
11/23/2015 Ditropan XL Oxybutynin Chloride Janssen Pharms Amneal Pharms
11/23/2015 Embeline Clobetasol Propionate Hi Tech Pharma Novel Labs
11/24/2015 Dextroamphetamine Sulfate Dextroamphetamine Sulfate Barr Avanthi
11/24/2015 Avodart Dutasteride GlaxoSmithKline Apotex
11/24/2015 Canasa Mesalamine Forest Labs Mylan
11/24/2015 Fazaclo ODT Clozapine Jazz Pharms Barr Labs
11/25/2015 Clozaril Clozapine Heritage Life Accord Healthcare
11/27/2015 Ampicillin Sodium Ampicillin Sodium Sandoz Sagent Pharms
11/27/2015 Paxil Paroxetine Hydrochloride Apotex Jubilant Generics
11/30/2015 Actonel Risedronate Sodium Warner Chilcott Apotex
11/30/2015 Actonel Risedronate Sodium Warner Chilcott Sun Pharma Global
11/30/2015 Actonel Risedronate Sodium Warner Chilcott Aurobindo Pharma
11/30/2015 Actonel Risedronate Sodium Warner Chilcott Mylan
11/30/2015 Namenda Memantine Hydrochloride Forest Labs Ajanta Pharma
12/1/2015 Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate Luitpold Aurobindo Pharma
12/2/2015 Solaraze Diclofenac Sodium Fougera Pharms Actavis Mid Atlantic
12/3/2015 Gleevec Imatinib Mesylate Novartis Sun Pharma
12/4/2015 Trivora-28 Elifemme Watson Labs SandozÂ
12/4/2015 Butapap Butalbital / Acetaminophen Mikart Larken Labs
12/4/2015 Focalin Dexmethylphenidate Hydrochloride Novartis Novel Labs
12/4/2015 Focalin Demethylphenidate Hydrochloride Novaris Abhai
12/7/2015 Patanol Olopatadine Hydrochloride Alcon Apotex
12/7/2015 Unasyn Ampicillin / Sulbactam Pfizer Antibiotics SA
12/7/2015 Avapro Irbesartan Sanofi Aventis Unichem Labs
12/7/2015 Patanol Olopatadine Hydrochloride Alcon USV North America
12/7/2015 Patanol Olopatadine Hydrochloride Alcon Zach System Spa
12/7/2015 Avapro Irbesartan Sanofi Aventis Sciegen Pharms
12/7/2015 Levothyroxine Sodium Levothyroxine Sodium Fresenius Kabi USA Par Sterile Products
12/7/2015 Namenda Memantine Hydrochloride Forest Labs Bio-Pharm
12/7/2015 Patanol Olopatadine Hydrochloride Alcon Novel Labs
12/8/2015 Potassium Chloride Potassium Chloride Actavis Labs FL Pharmaceutics Int'l
12/8/2015 Integrilin Eptifibatide Schering Aurobindo Pharma
12/8/2015 Plan B One-Step (OTC) Athentia Next (OTC) Teva Branded Pharm Aurobindo Pharma
12/9/2015 Amikacin Sulfate Amikacin Sulfate Eurohealth Intl Fresenius Kabi USA
12/9/2015 Amikacin Sulfate Amikacin Sulfate Eurohealth Intl Fresenius Kabi USA
12/9/2015 Pennsaid Diclofenac Sodium Nuvo Res Novel Labs
12/9/2015 Cyclogyl Cyclopentolate Hydrochloride Alcon Akorn
12/10/2015 Imitrex Statdose Sumatriptan Succinate GlaxoSmithKline Antares Pharma
12/10/2015 Avapro Irbesartan Sanofi Aventis Ajanta Pharma
12/10/2015 Fyavolv Norethindrone Acetate / Ethinyl Estradiol Barr Labs Lupin
12/10/2015 Toviaz Fesoterodine Fumarate Pfizer Alkem Labs
12/10/2015 Norvasc Amlodipine Besylate Pfizer Ascent Pharms
12/11/2015 Oxacillin Sodium Oxacillin Sodium Sandoz Hospira
12/11/2015 Niaspan Niacin Abbvie Amneal Pharms
12/11/2015 Starlix Nateglinide Novartis Alvogen Malta
12/11/2015 Cyanocobalamin / Vibisone Cyanocobalamin / Vibisone Luitpold / Fresenius Kabi USA Gavis Pharms
12/15/2015 Benzphetamine Hydrochloride Benzphetamine Hydrochloride KVK Tech Epic Pharma
12/15/2015 Citalopram Hydrobromide Citalopram Hydrobromide Roxane Hetero Labs
12/15/2015 Miralax (OTC) Polyethylene Glycol 3350 (OTC) Bayer Healthcare Ani Pharms
12/15/2015 Imodium A-D (OTC) Loperamide Hydrochloride (OTC) J & J Consumer Aurobindo Pharma
12/15/2015 Solu-Medrol Methylprednisolone Sodium Succinate Pharmacia and Upjohn Aurobindo Pharma
12/16/2015 Buspirone Hydrochloride Buspirone Hydrochloride Teva Orion Corp Orion
12/16/2015 Modicon 28 Cyclafem 0.5/35 Janssen Pharms Vintage Pharms
12/16/2015 MS Contin Morphine Sulfate Purdue Pharma Novel Labs
12/16/2015 Keppra Levetiracetam UCB Secan Pharms
12/17/2015 Aricept Donepezil Hydrochloride Eisai Actavis Elizabeth
12/17/2015 Kaitlib FEÂ Norethindrone / Ethinyl Estradiol / Ferrous Fumarate Warner Chilcott Lupin
12/17/2015 Perphenazine Perphenazine Sandoz Indicus Pharma
12/18/2015 Potassium Chloride Potassium Chloride Actavis Labs FL Lupin
12/18/2015 Corgard Nadolol US World Meds Invagen Pharms
12/18/2015 Patanol Olopatadine Hydrochloride Alcon Aurobindo Pharma
12/18/2015 Merrem Meropenem AstraZeneca Daewoong Pharm
12/21/2015 Zyvox Linezolid Pharmacia and Upjohn Mylan
12/21/2015 Zyvox Linezolid Pharmacia and Upjohn Glenmark Pharms
12/21/2015 Zyvox Linezolid Pharmacia and Upjohn Hetero Labs
12/21/2015 Focalin XR Dexmethylphenidate Hydrochloride Novartis Mylan
12/21/2015 Zyvox Linezolid Pharmacia and Upjohn Amneal Pharms
12/21/2015 Zyvox Linezolid Pharmacia and Upjohn Alembic Pharms
12/21/2015 Zyvox Linezolid Pharmacia and Upjohn Alkem Labs
12/21/2015 Busulfex Busulfan Otsuka Pharm Pharmaforce
12/22/2015 Ultram ER Tramadol Hydrochloride Valeant Mylan
12/22/2015 Diprivan Propofol Fresenius Kabi USA Watson Labs
12/22/2015 Pepcid Famotidine Valeant Pharms North Aurobindo Pharma
12/23/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Teva
12/23/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Teva
12/23/2015 Soriatane Acitretin Stiefel Labs Watson Labs
12/23/2015 Celexa Citalopram Hydrobromide Forest Labs Jubilant Generics
12/23/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Xellia Pharms
12/23/2015 Neurontin Gabapentin Pfizer Pharms Alkem Labs
12/23/2015 Celebrex Celecoxib GD Searle Torrent Pharms
12/24/2015 Reclast Zoledronic Acid Novartis Apotex
12/28/2015 Ortho-Novum 7/7/7-28 Norethindrone / Ethinyl Estradiol Janssen Pharms Jai Pharma
12/28/2015 Cefazolin Sodium Cafezolin Sodium Hospira Qilu Pharm
12/28/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Custopharm
12/28/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Custopharm
12/28/2015 Bloxiverz Neostigmine Methylsulfate Eclat Pharms Eurohealth Int'l
12/29/2015 Potassium Acetate Potassium Acetate Hospira Exela Pharma SCS
12/30/2015 Minocycline Hydrochloride Minocycline Hydrochloride Sandoz Sidmak Labs India

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