Print

ANDA Approvals

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
1/8/2018 Xenazine Tetrabenazine Valeant Pharms Dr Reddys
1/9/2018 Tamiflu Oseltamivir Phosphate Roche Lupin
1/12/2018 K-Tab Potassium Chloride AbbVie Paddock
1/16/2018 Ultiva Remifentanil HCl Mylan Fresenius Kabi
1/17/2018 Dilaudid Hydromorphone HCl Rhodes Pharms Ascent Pharms
1/19/2018 Taxotere Docetaxel Accord Healthcare / Sanofi Aventis Amneal
1/19/2018 Xyzal Allergy 24HR (OTC) Levocetirizine Dihydrochloride (OTC) Sanofi-Aventis Dr Reddys
1/23/2018 Epiduo Adapalene / Benzoyl Peroxide Galderma Labs Perrigo
1/23/2018 Bumex Bumetanide Validus Pharms Upsher-Smith Labs
1/23/2018 Celebrex Celecoxib GD Searle CSPC Ouyi Pharm
1/24/2018 Epiduo Adapalene / Benzoyl Peroxide Galderma Labs Taro
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Cipla 
1/26/2018 Truvada Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Aurobindo
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Hetero Labs
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Aurobindo
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Strides
1/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead MacLeods
1/26/2018 Argatroban Argatroban Novartis Amneal
1/26/2018 Feldene Piroxicam Pfizer Strides
1/29/2018 Kapvay Clonidine HCl Concordia Pharms Jubilant Generics
2/1/2018 Concerta Methylphenidate HCl Janssen Amneal
2/1/2018 Niaspan Niacin AbbVie Aurobindo
2/2/2018 Effient Prasugrel Eli Lilly Accord Healthcare
2/2/2018 Opana Oxymorphone HCl Endo Ascent Pharms
2/6/2018 Toprol-XL Metoprolol Succinate Aralez Pharms Novast Labs
2/7/2018 Syprine Trientine HCl Aton Watson
2/8/2018 Cleocin T Clindamycin Phosphate Pharmacia and Upjohn Glasshouse Pharms
2/9/2018 Tricor Fenofibrate AbbVie Amneal
2/9/2018 Namenda Memantine HCl Allergan Apotex
2/12/2018 Copaxone Glatopa Teva Sandoz
2/13/2018 Cardura Doxazosin Mesylate Pfizer Heritage Pharma
2/13/2018 Diprolene Betamethasone Dipropionate Merck Sharp Dohme Teligent Pharma
2/15/2018 Treximet Sumatriptan / Naproxen Sodium Pernix Ireland Aurobindo
2/16/2018 Adenocard Adenosine Astellas Gland Pharma
2/20/2018 Tamiflu Oseltamivir Phosphate Roche Lupin
2/21/2018 Feldene Piroxicam Pfizer Laboratorios Cinfa
2/22/2018 Zantac 150 (OTC) Ranitidine HCl (OTC) Sanofi Vivimed Global
2/23/2018 Strattera Atomoxetine HCl Eli Lilly Dr Reddys
2/23/2018 Lotronex Alosetron HCl Sebela Ireland Par
2/23/2018 Tamiflu Oseltamivir Phosphate Roche Hetero Labs
2/26/2018 Ritalin LA Methylphenidate HCl Novartis Mayne Pharma
2/26/2018 Suprane Desflurane Baxter Healthcare Shanghai Hengrui
2/26/2018 Viread Tenofovir Disoproxil Fumarate Gilead Laurus Labs
2/27/2018 Precedex Dexmedetomidine HCl Hospira Zydus
2/27/2018 Yaz Lo-Zumandimine Bayer Aurobindo
2/28/2018 Activella Estradiol / Norethindrone Acetate Amneal Accord Healthcare
3/2/2018 Bystolic Nebivolol HCl Allergan Torrent
3/2/2018 Viread Tenofovir Disoproxil Fumarate Gilead Qilu Tianhe
3/2/2018 Ritalin Methylphenidate HCl Novartis Bionpharma
3/5/2018 Eloxatin Oxaliplatin Sanofi Aventis / Teva Actavis
3/5/2018 Zantac 75 (OTC) Ranitidine HCl (OTC) Sanofi Vivimed Global
3/5/2018 Urocit-K Potassium Citrate Mission Pharma Teva
3/6/2018 Nuvigil Armodafinil Cephalon Aurobindo
3/6/2018 Gablofen Baclofen Piramal Mylan
3/7/2018 Integrilin Eptifibatide Schering Sagent
3/7/2018 Zovirax Acyclovir Mylan Yiling Pharm
3/8/2018 Sensipar Cinacalcet HCl Amgen Aurobindo
3/8/2018 Sensipar Cinacalcet HCl Amgen Cipla
3/9/2018 Zanaflex Tizanidine HCl Covis Pharma Zydus
3/12/2018 Sustiva Efavirenz Bristol-Myers Squibb Strides
3/13/2018 Sabril Vigabatrin Lundbeck Amneal
3/14/2018 Ziagen Abacavir Sulfate ViiV Healthcare Aurobindo
3/16/2018 Zegerid (OTC) Omeprazole / Sodium Bicarbonate (OTC) Bayer Zydus
3/16/2018 Solodyn Minocycline HCl Medicis Alkem Labs
3/16/2018 Naropin Ropivacaine HCl Fresenius Kabi Akorn
3/16/2018 Dacogen Decitabine Otsuka Sagent
3/16/2018 Topicort Desoximetasone Taro Lupin
3/16/2018 Glucophage XR Metformin HCl Bristol-Myers Squibb Granules
3/19/2018 Cyclophosphamide Cyclophosphamide West-Ward Pharms Amerigen Pharms
3/19/2018 Glucophage XR Metformin HCl Bristol-Myers Squibb Alignscience Pharma
3/20/2018 Renvela Sevelamer Carbonate Genzyme Sandoz
3/20/2018 Keppra Levetiracetam UCB Hainan Poly Pharm
3/20/2018 Ultravate Halobetasol Propionate Sun Pharm Inds Teligent Pharma
3/21/2018 Concerta Methylphenidate HCl Janssen Actavis
3/21/2018 Patanol Olopatadine HCl Novartis Micro Labs
3/21/2018 Loestrin 24 FE Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Apil Apotex
3/21/2018 Lioresal Baclofen Saol Theraps Res Mylan
3/22/2018 Concerta Methylphenidate HCl Janssen Actavis
3/23/2018 Aloxi Palonosetron HCl Helsinn Healthcare Teva
3/23/2018 Lialda Mesalamine Shire Actavis
3/23/2018 Toprol-XL Metoprolol Succinate Aralez Pharms Zydus
3/26/2018 Tikosyn Dofetilide Pfizer Sigmapharm Labs
3/26/2018 Clobex Clobetasol Propionate Galderma Labs Lupin
3/26/2018 Clobex Clobetasol Propionate Galderma Labs Taro
3/26/2018 Clobex Clobetasol Propionate Galderma Labs Glenmark
3/26/2018 Yasmin Zumandimine Bayer Aurobindo
3/28/2018 Advil Liqui-Gels (OTC) / Advil Migraine Liqui-Gels (OTC) Ibuprofen (OTC) Pfizer Strides
3/30/2018 Nimbex Cisatracurium Besylate AbbVie Hospira
3/30/2018 Nimbex Cisatracurium Besylate AbbVie Hospira
3/30/2018 Lipitor Atorvastatin Calcium Pfizer Accord Healthcare
3/30/2018 Dolophine Methadone HCl West-Ward Pharms Sun Pharm

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.