Print

ANDA Approvals

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
4/3/2017 Nasonex Mometasone Furoate Merck Sharp Dohme Amneal
4/3/2017 Tazorac / Avage Tazarotene Allergan Taro
4/4/2017 Ativan Lorazepam West-Ward Pharms Sagent Agila
4/4/2017 Celebrex Celecoxib GD Searle Jubilant Generics
4/6/2017 Wellbutrin XL Bupropion Hydrochloride Valeant Lupin
4/7/2017 Avodart Dutasteride GlaxoSmithKline Marksans Pharma
4/7/2017 Seasonique Simpesse Teva Aurobindo
4/7/2017 Entocort EC Budesonide Perrigo Appco Pharma
4/10/2017 Naftin Naftifine Hydrochloride Sebela Ireland Tolmar
4/12/2017 Wellbutrin XL Bupropion Hydrochloride Valeant Sciegen Pharms
4/14/2017 Perphenazine Perphenazine Sandoz Mylan
4/18/2017 Temodar Temozolomide Merck Sharp Dohme Watson / Teva
4/18/2017 Integrilin Eptifibatide Schering Akorn
4/18/2017 Singulair Montelukast Sodium Merck CSPC Ouyi Pharm
4/18/2017 Amidate Etomidate Hospira Gland Pharma
4/19/2017 Dexilant Dexlansoprazole Takeda Par
4/20/2017 Felbatol Felbamate Mylan Taro
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Teva
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Torrent
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Alembic
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Aurobindo
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo MacLeods
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Zydus
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Jubilant Generics
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Alkem Labs
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Accord Healthcare
4/24/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Teva
4/24/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Alembic
4/24/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Aurobindo
4/24/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Prinston
4/24/2017 Singulair Montelukast Sodium Merck CSPC Ouyi Pharm
4/25/2017 Rayos Prednisone Horizon Pharma Actavis Labs
4/26/2017 Vytorin Ezetimibe / Simvastatin Merck Sharp & Dohme Dr. Reddys
4/26/2017 Vytorin Ezetimibe / Simvastatin Merck Sharp & Dohme Impax
4/26/2017 Vytorin Ezetimibe / Simvastatin Merck Sharp & Dohme Watson
4/26/2017 Precedex Dexmedetomidine Hydrochloride Hospira West-Ward Pharms
4/26/2017 Singulair Montelukast Sodium Merck Perrigo
4/26/2017 Temodar Temozolomide Merck Sharp Dohme Deva Holding
4/26/2017 Bloxiverz Neostigmine Methylsulfate Eclat Pharms Par Sterile Products
4/27/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Lupin
4/27/2017 Cortef Hydrocortisone Pharmacia and Upjohn PII
4/27/2017 Sabril Vigabatrin Lundbeck Pharms Par Pharm
4/28/2017 Ativan Lorazepam West-Ward Pharms Sagent Agila
4/28/2017 Ortho-Novum 1/35-28 Norethindrone / Ethinyl Estradiol Janssen Accord Healthcare
4/28/2017 Clobex Clobetasol Propionate Galderma Labs Akorn
4/28/2017 Dymista Azelastine Hydrochloride / Fluticasone Propionate Mylan Apotex
4/28/2017 Mepron Atovaquone GlaxoSmithKline Paddock
5/2/2017 Ultracet Tramadol Hydrochloride / Acetaminophen Janssen MacLeods
5/3/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Torrent
5/3/2017 Micardis Telmisartan Boehringer Ingelheim Prinston
5/4/2017 Entocort EC Budesonide Perrigo Zydus
5/4/2017 Daypro Oxaprozin GD Searle Amneal
5/5/2017 Combivir Lamivudine / Zidovudine ViiV Healthcare Aurobindo Pharma
5/5/2017 Elestat Epinastine Hydrohcloride Allergan Akorn
5/5/2017 Avelox in Sodium Chloride 0.8% in Plastic Container Moxifloxacin Hydrochloride in Sodium Chloride 0.8% in Plastic Container Bayer Healthcare Mylan
5/5/2017 Calan SR Verapamil Hydrochloride Pfizer Cadila Pharms
5/5/2017 Motrin IB (OTC) Ibuprofen (OTC) Johnson and Johnson Aiping Pharm
5/8/2017 Ammonul Sodium Phenylacetate / Sodium Benzoate Medicis Maia Pharms
5/9/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Par
5/9/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Accord Healthcare
5/9/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Intellipharmaceutics
5/9/2017 Clolar Clofarabine Genzyme Abon Pharms
5/9/2017 Metronidazole in Plastic Container / Metro I.V. in Plastic Container / Flagyl I.V. RTU in Plastic Container Metronidazole in Plastic Container Hospira / B Braun / Baxter Healthcare Mylan
5/9/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Pharmadax
5/11/2017 Baraclude Entecavir Bristol Myers Squibb Sandoz
5/11/2017 Ritalin Methylpenidate Hydrochloride Novartis Abhai
5/11/2017 Soma Carisoprodol Mylan Nostrum Labs
5/12/2017 Precedex Dexmedetomidine Hydrochloride Hospira Luitpold Pharms
5/12/2017 Oxaliplatin / Eloxatin Oxaliplatin Teva  / Sanofi Aventis Luitpold Pharms
5/12/2017 Haldol Haloperidol Decanoate Janssen Gland Pharma
5/12/2017 Glucotrol XL Glipizide Pfizer Aurobindo
5/12/2017 Trilipix Fenofibric Acid AbbVie Alembic
5/15/2017 Azilect Rasagiline Mesylate Teva Mylan
5/15/2017 Zutripro Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride Cypress Pharm Bio-Pharm
5/15/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Aurobindo
5/15/2017 Pennsaid Diclofenac Sodium Horizon Pharma Actavis
5/15/2017 Macrobid Nitrofurantoin (Monohydrate/ Macrocrystals) Alvogen Malta Amneal
5/15/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Jubilant Generics
5/15/2017 Doxil (Liposomal) Doxorubicin Hydrochloride (Liposomal) Janssen Dr. Reddys
5/17/2017 Nexium IV Esomeprazole Sodium AstraZeneca Mylan Labs
5/17/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Lupin
5/17/2017 Lexapro Escitalopram Oxalate Forest Labs Amneal
5/17/2017 Tamiflu Oseltamivir Phosphate Roche Amneal
5/18/2017 Cymbalta Duloxetine Hydrochloride Lilly Prinston
5/22/2017 Argatroban in Sodium Chloride Argatroban in Sodium Chloride Sandoz Gland Pharma
5/23/2017 Namenda Memantine Hydrochloride Forest Labs Strides Pharma
5/23/2017 Abilify Aripiprazole Otsuka Orchid Healthcare
5/23/2017 Zestoretic Lisinopril / Hydroclorothiazide Alvogen Malta Invagen Pharms
5/23/2017 Gemcitabine Hydrochloride Gemcitabine Hydrochloride Hospira Apotex
5/24/2017 Luxiq Betamethasone Valerate Mylan RiconPharma
5/24/2017 Luxiq Betamethasone Valerate Mylan Taro Pharm
5/24/2017 Hectorol Doxercalciferol Genzyme Amneal
5/24/2017 Hectorol Doxercalciferol Genzyme Amneal
5/25/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Glenmark
5/25/2017 Sodium Chloride 0.9% in Plastic Container Sodium Chloride 0.9% in Plastic Container B Braun / Baxter Healthcare / Hospira / ICU Medical Inc Laboratorios Grifols
5/26/2017 Angiomax Bivalirudin The Medicines Co Dr Reddys
5/26/2017 Camptosar Irinotecan Hydrochloride Pfizer Ingenus Pharms
5/26/2017 DDAVP Desmopressin Acetate Ferring Heritage Pharma
5/30/2017 Strattera Atomoxetine Hydrochloride Eli Lilly Apotex
5/30/2017 Strattera Atoxoxetine Hydrochloride Eli Lilly Aurobindo Pharma
5/30/2017 Strattera Atomoxetine Hydrochloride Eli Lilly Glenmark
5/30/2017 Strattera Atoxoxetine Hydrochloride Eli Lilly Teva
5/30/2017 Zyprexa Zydis Olanzapine Eli Lilly Ajanta Pharma
5/30/2017 Motrin IB (OTC) Ibuprofen (OTC) Johnson and Johnson Strides Pharma
5/30/2017 Felbatol Felbamate Mylan Zydus
5/31/2017 Dacogen Decitabine Otsuka Pharm Pharmascience
6/1/2017 Remeron Soltab Mirtazapine Organon USA Zydus
6/1/2017 Levaquin Levofloxacin Janssen Zydus
6/2/20017 Corgard Nadolol US Worldmeds Amneal
6/5/2017 Lialda Mesalamine Shire Zydus
6/5/2017 Comtan Entacapone Orion Pharma MacLeods
6/8/2017 Avalide Irbesartan / Hydrochlorothiazide Sanofi Aventis West-Ward Pharms
6/8/2017 Cardizem CD Diltiazem Hydrochloride Valeant Sun Pharm
6/9/2017 Vituz Hydrocodone Bitartrate / Chlorpheniramine Maleate Cypress Pharm Acella Pharms
6/12/2017 Roxicodone Oxycodone Hydrochloride Mallinckrodt Novel Labs
6/12/2017 Zetia Ezetimibe Merck Sharp & Dohme Zydus
6/12/2017 Zetia Ezetimibe Merck Sharp & Dohme OHM Labs
6/12/2017 Zetia Ezetimibe Merck Sharp & Dohme Apotex
6/12/2017 Zetia Ezetimibe Merck Sharp & Dohme Amneal
6/12/2017 Sporanox Itraconazole Janssen Alkem Labs
6/13/2017 Renvela Sevelamer Carbonate Genzyme Aurobindo
6/13/2017 Rocaltrol Calcitriol Validus Pharms Amneal
6/14/2017 Acticlate Doxycycline Hyclate Aqua Pharms Mayne Pharma
6/15/2017 Skelaxin Metaxalone King Pharms Actavis Labs
6/15/2017 Loestrin 24 FE Aurovela 24 FE Apil Aurobindo
6/15/2017 Loestrin FE 1.5/30 Aurovela FE 1.5/30 Apil Aurobindo
6/16/2017 Niaspan Niacin AbbVie Lannett
6/16/2017 Zyprexa Olanzapine Lilly Hikma
6/16/2017 Nimbex Cisatracurium Besylate Preservative Free AbbVie Accord Healthcare
6/16/2017 Felbatol Felbamate Mylan Taro Pharm
6/16/2017 Relpax Eletriptan Hydrobromide Pfizer Zydus
6/19/2017 Dantrium Dantrolene Sodium Par Hikma
6/20/2017 Feldene Piroxicam Pfizer PII
6/20/2017 Brisdelle Paroxetine Mesylate Sebela Ireland Actavis Labs
6/20/2017 Flagyl Metronidazole GD Searle Orit Labs
6/20/2017 Atacand Candesartan Cilexetil AstraZeneca Alembic Pharms
6/21/2017 Gleevec Imatinib Mesylate Novartis Mylan
6/22/2017 Morphine Sulfate Morphine Sulfate West-Ward Pharms Rhodes Pharms
6/22/2017 Robaxin Methocarbamol West-Ward Pharms Luitpold Pharms
6/23/2017 Baraclude Entecavir Bristol Myers Squibb Zydus
6/23/2017 Vidaza Azacitidine Celgene Natco Pharma
6/26/2017 Ditropan XL Oxybutynin Chloride Janssen Zydus
6/27/2017 Benzaclin Clindamycin Phosphate / Benzoyl Peroxide Valeant Tolmar
6/27/2017 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Micro Labs
6/27/2017 Dexedrine Dextroamphetamine Sulfate Amedra Pharms Nesher Pharms
6/27/2017 Children's Motrin (OTC) Ibuprofen (OTC) Johnson and Johnson Taro
6/28/2017 Tobrex Tobramycin Novartis Somerset Theraps
6/28/2017 Cleocin  Clindamycin Phosphate in 5% Dextrose in Plastic Container Pharmacia and Upjohn Celerity Pharms
6/30/2017 Zomig Zolmitriptan IPR Appco Pharma
6/30/2017 Wellbutrin XL Bupropion Hydrochloride Valeant Anbison Lab
6/30/2017 Wellbutrin XL Bupropion Hydrochloride Valeant Jubilant Generics

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.