ANDA Approvals

Spring 2016

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
1/4/2016 Diovan Valsartan Novartis Ivax
1/5/2016 Gemzar Gemcitabine Hydrochloride Eli Lilly Gland Pharma
1/6/2016 Naftin Naftifine Hydrochloride Merz Pharms Taro
1/7/2016 Nystatin Nystatin Wockhardt Pharm Assoc
1/7/2016 Dapsone Dapsone Jacobus Fera Pharms
1/8/2016 Aygestin Norethindrone Acetate Duramed Res Aurobindo
1/8/2016 Lodosyn Carbidopa Aton Alvogen Malta
1/8/2016 Unasyn Ampicillin / Sulbactam Pfizer Sagent Pharms
1/11/2016 Unasyn Ampicillin / Sulbactam Pfizer Sagent Pharms
1/11/2016 Diovan Valsartan Novartis Amneal
1/11/2016 Felbatol Felbamate Meda Pharms Mylan
1/11/2016 Xyzal Levocetirizine Dihydrochloride UCB MacLeods Pharms
1/12/2016 Singulair Montelukast Sodium Merck Anbison Lab
1/13/2016 Prevacid 24 Hr (OTC) Lansoprazole (OTC) Novartis Natco Pharma
1/13/2016 Zemplar Paricalcitol Abbvie Amneal
1/13/2016 Pindolol Pindolol Mylan Nostrum Labs
1/14/2016 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Aurobindo
1/14/2016 Avelox Moxifloxacin Hydrochloride Bayer Crossmedika
1/14/2016 Zemplar Paricalcitol Abbvie Aurobindo
1/15/2016 Avalide Irbesartan / Hydrochlorothiazide Sanofi Aventis Int'l Specialty Chemicals
1/19/2016 Potassium Chloride Potassium Chloride Actavis Glenmark
1/19/2016 Rifadin Rifampin Sanofi Aventis Watson
1/20/2016 Silenor Doxepin Hydrochloride Pernix Theraps Mylan
1/21/2016 Vancomycin Hydrochloride Vancomycin Hydrochloride   Fresenius Kabi USA / Hospira Gland Pharma
1/21/2016 Klor-Con M20 Potassium Chloride Upsher Smith Novel Labs
1/22/2016 Vfend Voriconazole PF Prism Aurobindo
1/26/2016 Exjade Deferasirox Novartis Actavis
1/26/2016 Protonix Pantoprazole Sodium Wyeth Amneal
1/27/2016 Lescol XL Fluvastatin Sodium Novartis Teva
1/27/2016 Ortho Cyclen-28 Norgestimate / Ethinyl Estradiol Janssen Jai Pharma
1/27/2016 Zyprexa  Olanzapine Eli Lilly Qilu Pharm
1/27/2016 Dexedrine Dextroamphetamine Sulfate Amedra Pharms Mylan
1/28/2016 Uroxatral Alfuzosin Hydrochloride Concordia Pharms Unichem Labs
1/29/2016 Minocycline Hydrochloride Minocycline Hydrochloride Par Sun Pharm
1/29/2016 Buprenorphine Hydrochloride Burprenorphine Hydrocloride Roxane Sun Pharm
1/29/2016 Peridex Periogard 3M Colgate-Palmolive
2/1/2016 Maxipime Cefepime Hydrochloride Hospira Qilu Pharm
2/1/2016 Keppra Levetiracetam UCB Aurobindo
2/1/2016 Lidocaine Lidocaine Fougera Teligent Pharma 
2/1/2016 Celebrex Celecoxib GD Searle Aurobindo
2/2/2016 Isosulfan Blue Isosulfan Blue Mylan Aurobindo
2/3/2016 Xenazine Tetrabenazine Valeant Hetero Labs
2/3/2016 Ammonia N 13 Ammonia N 13 Feinstein MA General Hosp
2/4/2016 Neurontin Gabapentin Pfizer Sciegen Pharms
2/5/2016 Zyvox Linezolid Pharmacia and Upjohn Gate Pharms
2/5/2016 Boniva Ibandronate Sodium Roche Accord Healthcare
2/5/2016 Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate Barr Actavis
2/8/2016 Diovan HCT Valsartan / Hydrochlorothiazide Novartis Prinston
2/9/2016 Precedex Dexmedetomidine Hydrochloride Hospira Accord Healthcare
2/9/2016 Zovia 1/50E-28 Ethynodiol Diacetate / Ethinyl Estradiol Watson Labs Jai Pharma
2/9/2016 Wellbutrin SR Bupropion Hydrochloride GlaxoSmithKline Invagen Pharms
2/10/2016 Temodar Temozolomide Merck Sharp Dohme Kremers Urban
2/10/2016 Levaquin in Dextrose 5% in Plastic Container Levofloxacin in Dextrose 5% in Plastic Container Janssen Aurobindo
2/16/2016 Adderall XR 30 Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate Shire Impax Labs
2/16/2016 Macrodantin Nitrofurantoin Alvogen Malta Sun Pharm
2/16/2016 Solu-Medrol Methylprednisolone Sodium Succinate Pharmacia and Upjohn Hikma Farmaceutica
2/16/2016 Pristiq Desvenlafaxine Succinate Wyeth Roxane
2/17/2016 Sustiva Efavirenz Bristol Myers Squibb Mylan
2/17/2016 Flouorouracil Flouorouracil Accord Healthcare / Fresenius Kabi USA/Teva Sagent Pharms
2/17/2016 Lodosyn Carbidopa Aton Edenbridge Pharms
2/18/2016 Maxalt Rizatriptan Benzoate Merck Alkem Labs
2/18/2016 Neurontin Gabapentin Pfizer Sciegen Pharms
2/18/2016 Monodox Doxycycline Aqua Pharms Zydus
2/18/2016 Dantrium Dantrolene Sodium Par Sterile Products Mylan
2/19/2016 Claforan Cefotaxime Sodium Sanofi Aventis  / US Pharm Holdings Hospira
2/19/2016 Aricept Donepezil Hydrochloride Eisai Dexcel Pharma
2/19/2016 Imitrex  Sumatriptan GlaxoSmithKline Lannett
2/23/2016 Ortho Tri-Cyclen Lo Norgestimate / Ethinyl Estradiol Janssen Glenmark
2/23/2016 Keppra XR Levetiracetam UCB Intellipharmaceutics
2/23/2016 Zipsor Diclofenac Potassium Depomed Bionpharma
2/24/2016 Zemplar Paricalcitol Abbvie Lotus Pharm
2/24/2016 Ammonul Sodium Phenylacetate / Sodium Benzoate Medicis Ailex Pharms
2/25/2016 Amidate Etomidate Hospira Hikma Farmaceutica
2/25/2016 Cyklokapron Tranexamic Acid Pharmacia and Upjohn North Creek Pharms
2/25/2016 Topicort Desoximetasone Taro Teligent Pharma
2/26/2016 Nicorette (OTC) Nicotine Polacrilex (OTC) GlaxoSmithKline Actavis
2/29/2016 Clarithromycin Clarithromycin Teva Allied Pharma
2/29/2016 Metadate ER Methylphenidate Hydrochloride UCB Tedor Pharma
2/29/2016 Acyclovir Sodium Acyclovir Sodium Fresenius Kabi USA Hikma Pharms
2/29/2016 Glucovance Glyburide / Metformin Hydrochloride Bristol Myers Squibb Zydus
2/29/2016 Ditropan XL Oxybutynin Chloride Janssen Accord Healthcare
2/29/2016 Acetadote Acetylcysteine Cumberland Pharms Aurobindo
2/29/2016 Flonase Allergy Relief (OTC) Fluticasone Propionate (OTC) GlaxoSmithKline Apotex
3/1/2016 Wellbutrin SR Bupropion Hydrochloride GlaxoSmithKline Sciegen Pharms
3/2/2016 Magnesium Sulfate in Dextrose 5% in Plastic Container Magnesium Sulfate in Dextrose 5% in Plastic Containers Hospira HQ Specialty Pharma
3/3/2016 Rifadin Rifampin Sanofi Aventis Hikma Pharms
3/3/2016 Axert Almotriptan Malate Janssen Ajanta Pharma
3/4/2016 Potassium Chloride Potassium Chloride Actavis Tris Pharma
3/4/2016 Epivir Lamivudine VIIV Healthcare Mylan
3/7/2016 Oxistat Oxiconazole Nitrate Fougera Pharms Taro
3/7/2016 Magnesium Sulfate in Dextrose 5% in Plastic Container Magnesium Sulfate in Dextrose 5% in Plastic Container Hospira Fresenius Kabi USA
3/8/2016 Seroquel Quetiapine Fumarate AstraZeneca Unichem Labs
3/8/2016 Pulmicort Respules Budesonide AstraZeneca Teva
3/8/2016 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Amneal
3/8/2016 Children's Cetirizine Hydrochloride Allergy Children's Cetirizine Hydrochloride Allergy Sandoz Novel Labs
3/8/2016 Zofran Preservative Free Ondansetron Hydrochloride Preservative Free Novartis Accord Healthcare
3/11/2016 Boniva Ibandronate Sodium Hoffmann LA Roche Aurobindo
3/11/2016 Frova Frovatriptan Succinate Endo Glenmark
3/11/2016 Plan B One-Step Levonorgestrel Teva Branded Novast Labs
3/14/2016 Neurontin Gabapentin Parke Davis Tris Pharma
3/15/2016 Azilect Rasagiline Mesylate Teva Branded Orchid Healthcare
3/15/2016 Zyprexa  Olanzapine Eli Lilly Invagen
3/15/2016 Zyvox Linezolid Pharmacia and Upjohn Fresenius Kabi USA
3/15/2016 Magnesium Sulfate in Plastic Container Magnesium Sulfate in Plastic Container Hospira Fresenius Kabi USA
3/16/2016 Zyprexa Zydis Olanzapine Eli Lilly Invagen
3/16/2016 Dextroamphetamine Sulfate Dextroamphetamine Sulfate Barr Novel Labs
3/16/2016 Celebrex Celecoxib GD Searle MacLeods
3/17/2016 Precedex Dexmedetomidine Hydrochloride Hospira Aurobindo
3/17/2016 Avodart Dutasteride GlaxoSmithKline Intergel Pharms
3/17/2016 Norpramin Desipramine Hydrochloride US Pharm Holdings Amneal
3/18/2016 Valcyte Valganciclovir Hydrochloride Hoffmann LA Roche Hetero Labs
3/18/2016 Aleve (OTC) Naproxen Sodium (OTC) Bayer Aurobindo
3/18/2016 Voltaren Diclofenac Sodium GlaxoSmithKline Amneal
3/22/2016 Nasonex Mometasone Furoate Merck Sharp Dohme Apotex
3/22/2016 Xopenex Levalbuterol Hydrochloride Oak Pharms Ritedose
3/22/2016 Ofirmev Acetaminophen Mallinckrodt Sandoz
3/22/2016 Evista Raloxifene Hydrochloride Eli Lilly Novel Labs
3/23/2016 Femcon Fe Norethindrone / Ethinyl Estradiol / Ferrous Fumarate Allergan Lupin
3/23/2016 Temodar Temozolomide Merck Sharp Dohme Lannett
3/23/2016 Vfend Voriconazole PF Prism CV Alvogen
3/24/2016 Temodar Temozolomide Merck Sharp Dohme Roxane
3/24/2016 Treanda Bendamustine Hydrochloride Cephalon Glenmark
3/24/2016 Treanda Bendamustine Hydrochloride Cephalon Innopharma 
3/24/2016 Thyroshield (OTC) Potassium Iodide (OTC) Arco Pharms Mission Pharmacal
3/25/2016 Cubicin Daptomycin Cubist Teva
3/25/2016 Zovirax Acyclovir Delcor Asset Zydus
3/25/2016 Exelon Rivastigmine Tartrate Novartis Aurobindo
3/25/2016 Yasmin Drospirenone / Ethinyl Estradiol Bayer Glenmark
3/25/2016 Plan B One-Step Levonorgestrel Teva Branded Glenmark
3/28/2016 Potassium Chloride Potassium Chloride Actavis Kremers Urban
3/28/2016 Carboplatin Carboplatin Pharmachemie / Teva Sanja Pharms
3/28/2016 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Aurobindo
3/28/2016 Dextroamphetamine Sulfate Dextroamphetamine Sulfate Barr Nesher Pharms
3/29/2016 Diamox Acetazolamide Teva Branded Nostrum Labs
3/30/2016 Neoprofen Ibuprofen Lysine Recordati Rare Exela Pharma Science
3/30/2016 Rilutek Riluzole Covis Pharma Alkem Labs
3/30/2016 Protonix IV Pantoprazole Sodium Wyeth Pharms Inc Aurobindo
3/31/2016 Lexapro Escitalopram Oxalate Forest Labs MacLeods Pharms
3/31/2016 Valcyte Valganciclovir Hydrochloride Hoffmann LA Roche Aurobindo
3/31/2016 Oxycodone Hydrochloride Oxycodone Hydrochloride Lehigh Valley Ani Pharms
3/31/2016 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA/Hospira Aurobindo
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