ANDA Approvals

New Drug Applications and 505(b)(2) Applications

Third Quarter

GENERICally Speaking

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
7/01/2021 Truvada Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Zydus Pharms
7/01/2021 Docetaxel Docetaxel Hospira Gland Pharma
7/01/2021 Mucinex DM Guaifenesin / Dextromethorphan Hydrobromide Indivior Sun
7/02/2021 Lyrica CR Pregabalin Pfizer Mylan
7/02/2021 Cedazuridine Decitabine Otsuka Meitheal
7/06/2021 Invega Sustenna Paliperidone Palmitate Johnson & Johnson Teva
7/06/2021 Lyrica CR Pregabalin Pfizer Alvogen
7/06/2021 Robinul Glycopyrrolate AH Robins Meitheal
7/06/2021 Deltasone Prednisone Pharmacia / Upjohn Novitium Pharma
7/7/2021 Norpramin Desipramine HCl Validus Alembic
7/7/2021 Lyrica Pregabalin Upjohn Apotex
7/8/2021 Tarceva Erlotinib HCl OSI Pharma Alembi
7/9/2021 Brilinta Ticagrelor AstraZeneca Mylan
7/9/2021 Trileptal Oxcarbazepine Novartis Akorn
7/9/2021 Mycamine Micafungin Sodium Astellas Hikma
7/9/2021 Mycamine Micafungin Sodium Astellas Jiangsu Hansoh Pharm
7/12/2021 Promethazine Hydrochloride Plain Promethazine HCl ANI Pharma Quagen
7/12/2021 Nitropress Sodium Nitroprusside AbbVie Be Pharms
7/13/2021 Imitrex Sumatriptan Succinate Glaxo Caplin
7/13/2021 Lioresal Baclofen Novartis Aurobindo
7/14/2021 Lipitor Atorvastatin Calcium Upjohn Dr Reddys Labs
7/15/2021 Arthrotec Diclofenac Sodium / Misoprostol Pfizer Micro Labs
7/15/2021 Estrace Estradiol AbbVie Prasco Labs
7/15/2021 Tobradex Tobramycin / Dexamethasone Novartis Amneal
7/15/2021 Apriso Mesalamine Bausch & Lomb Alkem
7/15/2021 Lyrica Pregabalin Upjohn Changzhou Pharm
7/16/2021 Samsca Tolvaptan Otuska Hetero Labs
7/16/2021 Lioresal Baclofen Novartis Beximco Pharms
7/19/2021 Adalat CC Nifedipine Alvogen Aurobindo
7/20/2021 Vimovo Naproxen / Esomeprazole Magnesium Horizon Mylan
7/20/2021 Taytulla Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate AbbVie Amneal
7/26/2021 Eliquis Apixaban Bristol-Myers Squibb Breckenridge
7/26/2021 Ery-Tab Erythromycin Arbor Torrent
7/26/2021 Atropine Sulfate Atropine Sulfate Hospira Accord Healthcare
7/26/2021 Haldol Haloperidol Decanoate Janssen Meitheal
7/27/2021 Daraprim Pyrimethamine Vyera Alvogen / Fera
7/27/2021 Emla Lidocaine / Prilocaine Teva Acrux
7/28/2021 Sabril Vigabatrin Lundbeck Specgx
7/28/2021 Actigall Ursodiol AbbVie Vgyaan
7/29/2021 Sabril Vigabatrin Lundbeck Navisci
7/29/2021 CellCept Mycophenolate Mofetil Roche Lannett
7/29/2021 Emend Fosaprepitant Dimeglumine Merck Aspiro
7/29/2021 Paraflex Chlorzoxazone Ortho McNeil Senores Pharms
7/29/2021 Faslodex Fulvestrant AstraZeneca Zydus
7/30/2021 Potassium Chloride 10meq in Dextrose 5% and Sodium Chloride 0.225% in Plastic Container Potassium Chloride 10meq in Dextrose 5% and Sodium Chloride 0.225% in Plastic Container ICU Medical Fresenius Kabi
7/30/2021 Potassium Chloride 20meq in Dextrose 5% and Sodium Chloride 0.225% in Plastic Container Potassium Chloride 20meq in Dextrose 5% and Sodium Chloride 0.225% in Plastic Container ICU Medical Fresenius Kabi
8/02/2021 Detrol Tolterodine Tartrate Pfizer Hetero Labs
8/02/2021 BiCNU Carmustine Emcure Meitheal
8/03/2021 Belbuca Buprenorphine HCl Biodelivery Alvogen
8/03/2021 Duexis Ibuprofen / Famotidine Horizon Alkem
8/03/2021 Nicorette Nicotine Polacrilex Glaxo Aurobindo
8/03/2021 Glumetza Metformin HCl Santarus Amta
8/04/2021 Kadian Morphine Sulfate AbbVie Nortec Dev
8/04/2021 Anafranil Clomipramine HCl SpecGx Alembic
8/04/2021 Hexadrol Dexamethasone / Sodium Phosphate Aspen Global Gland Pharma
8/06/2021 Effexor XR Venlafaxine HCl Upjohn Yichang Humanwell
8/9/2021 Cuvposa Glycopyrrolate Merz Par
8/9/2021 Durezol Difluprednate Novartis Cipla
8/9/2021 Namenda XR Memantine HCl AbbVie Aurobindo
8/10/2021 Epaned O.S. Enalapril Maleate Silver Bionpharma
8/11/2021 Chantix Varenicline Pfizer Par
8/11/2021 Aggrenox Aspirin / Dipyridamole Boehringer-Ingelheim Micro Labs
8/11/2021 Imodium Loperamide HCl Johnson & Johnson Strides Pharma
8/11/2021 Glucophage XR Metformin HCl EMD Serono Unichem
8/11/2021 Paxil CR Paroxetine HCl Glaxo Sinotherapeutics
8/12/2021 Colcrys Colchicine Takeda Par
8/12/2021 Apriso Mesalamine Bausch & Lomb Zydus
8/13/2021 Colcrys Colchicine Takeda Hetero Labs
8/13/2021 Syprine Trientine HCl Bausch & Lomb Eci Pharms
8/13/2021 Clindagel Clindamycin Phosphate Bausch & Lomb Solaris Pharma
8/13/2021 Faslodex Fulvestrant AstraZeneca Xiromed
8/13/2021 Lupron Leuprolide Acetate AbbVie Vgyaan
8/13/2021 Daraprim Pyrimethamine Vyera Teva
8/16/2021 Sutent Sunitinib Malate Pfizer Sun Pharm
8/16/2021 Tegretol Carbamazepine Novartis Vgyaan
8/17/2021 Mykacet Nystatin / Triamcinolone Acetonide Cossette Macleod
8/18/2021 Trandate Labetalol HCl Alvogen Rubicon
8/19/2021 Cuprimine Penicillamine Bausch & Lomb Invagen Pharms
8/19/2021 Xeljanz XR Tofacitinib Pfizer Zydus
8/19/2021 Diamox Acetazolamide Teva Rubicon
8/20/2021 Symmetrel Amantadine HCl Endo Invatech
8/20/2021 Rubramin PC Cyanocobalamin Bristol-Myers Squibb Xiromed
8/20/2021 Zaroxolyn Metolazone Lannett Rubicon
8/23/2021 Cuprimine Penicillamine Bausch Aggrega
8/24/2021 Latuda Lurasidone HCl Sunovion Dr Reddys Labs
8/24/2021 Aramine Metaraminol Bitartrate Merck Slayback
8/24/2021 Cubicin Daptomycin Merck Qilu
8/25/2021 Ortho Evra Onsura Janssen Teva
8/25/2021 Tylenol Acetaminophen Johnson & Johnson Marksans Pharma
8/26/2021 Topamax Topiramate Janssen Ascent Pharms
8/27/2021 Paxil CR Paroxetine HCl Apotex Cadila Pharms
8/30/2021 Jentadueto Linagliptin / Metformin HCl Boehringer-Ingelheim Sunshine
8/30/2021 Protonix Pantoprazole Sodium Wyeth ACIC Pharms
8/30/2021 Tamiflu Oseltamivir Phosphate Roche Aptapharma
8/30/2021 Syprine Trientine HCl Bausch Accord Healthcare
8/31/2021 Tradjenta Linagliptin Boehringer-Ingelheim Sunshine
8/31/2021 Bactroban Mupirocin Glaxo Encube
9/02/2021 Cubicin Daptomycin Merck Eugia Pharma
9/02/2021 Lipitor Atorvastatin Calcium Upjohn August
9/03/2021 Axiron Testosterone Eli Lilly TWi Pharms
9/03/2021 Metrogel Metronidazole Galderma Aleor Dermaceuticals
9/03/2021 Aralen Chloroquine Phosphate Sanofi Aventis Suven Pharms
9/03/2021 Precedex Dexmedetomidine HCl Hospira Piramal
9/03/2021 Paxil Paroxetine HCl Apotex Novitium Pharma
9/7/2021 Integrilin Eptifibatide Schering Shuangcheng
9/7/2021 Evekeo Amphetamine Sulfate Arbor Rhodes Pharms
9/7/2021 Normodyne Labetalol HCl Schering Caplin
9/8/2021 Xylocaine with epinephrine Lidocaine HCl / Epinephrine Fresenius Kabi B Braun Medical
9/8/2021 Cerdelga Eliglustat Tartrate Sanofi Aizant
9/8/2021 Halog Halcinonide Sun Glasshouse Pharms
9/10/2021 Imodium Loperamide HCl / Simethicone Johnson & Johnson Bionpharma
9/13/2021 Atripla Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Macleods
9/13/2021 Motrin Ibuprofen McNeil Alkem
9/17/2021 Trintellix Vortioxetine Hydrobromide Takeda Zydus
9/17/2021 Quinaglute ER Quinidine Gluconate Bayer Eywa
9/17/2021 Ofirmev Acetaminophen Mallinckrodt Baxter Healthcare
9/20/2021 Evoclin Clindamycin Phosphate Mylan Glenmark
9/20/2021 Tricor Fenofibrate AbbVie Aurobindo
9/20/2021 Dacogen Decitabine Otsuka Eugia Pharma
9/21/2021 Medrol Methylprednisolone Pfizer Amneal
9/21/2021 Teflaro Ceftaroline Fosamil AbbVie Apotex
9/21/2021 Otezla Apremilast Amgen Alkem
9/21/2021 Otezla Apremilast Amgen Zydus
9/21/2021 Absorica Isotretinoin Sun Upsher Smith Labs
9/22/2021 Compazine Prochlorperazine Edisylate Glaxo Gland Pharma
9/23/2021 Myfortic Mycophenolic Acid Novartis Alkem
9/23/2021 Mirvaso Brimonidine Tartrate Galderma Padagis
9/23/2021 Butrans Buprenorphine Purdue Aveva
9/23/2021 Sabril Vigabatrin Lundbeck Dexcel Pharma
9/24/2021 Aubagio Teriflunomide Sanofi Breckenridge
9/28/2021 Compazine Prochlorperazine Edisylate Glaxo Viwit Pharm
9/29/2021 Fortamet Metformin HCl Andrx TWi Pharms
9/29/2021 Sabril Vigabatrin Lundbeck Aurobindo
9/29/2021 Adderall XR Detroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate Takeda Ascent Pharms
9/30/2021 Zomig Zolmitriptan AstraZeneca Padagis
9/30/2021 Tegretol XR Carbamazepine Novartis Anbison Lab
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