Line design
New Drug Applications and 505(b)(2) Applications
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
10/03/2022 Clolar Clofarabine Sanofi Eugia Pharma
10/03/2022 Briviact Brivaracetam UCB Zydus
10/04/2022 Combigan Brimonidine Tartrate / Timolol Maleate AbbVie Teva
10/04/2022 Valcyte Valganciclovir HCl Roche Hetero Labs
10/05/2022 Corlanor Ivabradine HCl Amgen Annora Pharma
10/06/2022 Lumigan 0.03% Bimatoprost Allergan Eugia Pharma
10/06/2022 Vimovo Naproxen / Esomeprazole Magnesium Horizon Ajanta
10/06/2022 Tegretol XR Carbamazepine Novartis Novitium Pharma
10/07/2022 Solodyn ER Minocycline HCl Bausch Sidmak Labs
10/07/2022 Abreva Docosanol Glaxo Encube
10/07/2022 Keppra Levetiracetam UCB MSN
10/11/2022 Ovcon 35 ethinyl estradiol / norethindrone Warner Chilcott Aurobindo
10/11/2022 Vfend Voriconazole Pfizer Mylan
10/11/2022 Velcade Bortezomib Sanofi Waverley Pharma
10/11/2022 Namenda XR Memantine HCl AbbVie Xiamen LP Pharm
10/11/2022 Zyflo CR Zileuton Mylan Annora Pharma
10/12/2022 Adcirca tadalafil Eli Lilly Teva
10/12/2022 Theophylline Extended-Release Tablets Theophylline Bausch Teva
10/13/2022 Dilantin Extended Phenytoin Sodium Viatris Unichem
10/14/2022 Calcium Gluconate Calcium Gluconate Fresenius Kabi Nivagen Pharms
10/17/2022 Lasix Furosemide Validus Graviti Pharms
10/17/2022 Cytotec Misoprostol Pfizer Micro Labs
10/18/2022 Tecfidera Dimethyl Fumarate Biogen Prinston
10/18/2022 Cyclophosphamide Cyclophosphamide Baxter Xellia Pharms Aps
10/18/2022 Neptazane Methazolamide Lederle Tagi
10/18/2022 Toprol XL Metoprolol Succinate AstraZeneca Accord Healthcare
10/19/2022 Doxil Doxorubicin HCl (Liposomal) J&J Celerity Pharms
10/19/2022 Isuprel Isoproterenol HCl Bausch American Regent
10/20/2022 Paraflex Chlorzoxazone J&J Corepharma
10/20/2022 Taxol Paclitaxel HQ Specialty Pharma Alembic Pharms
10/21/2022 Minipress Prazosin HCl Pfizer Appco
10/21/2022 Cuyposa Glycopyrrolate Merz Amneal
10/21/2022 Toradol Ketorolac Tromethamine Roche Atnahs Pharma
10/21/2022 Toradol Ketorolac Tromethamine Roche Zydus
10/24/2022 Prolixin Fluphenazine HCl Bristol-Myers Squibb Upsher Smith Labs
10/24/2022 Mycamine Micafungin Sodium Astellas Zydus
10/24/2022 Zaroxolyn Metolazone Lannett Renata
10/24/2022 Vibra-Tabs Doxycycline Hyclate Pfizer Amneal
10/25/2022 Abilify Aripiprazole Bristol-Myers Squibb Glasshouse Pharms
10/25/2022 Zaroxolyn Metolazone Lannett Aace Pharms
10/25/2022 Ofirmev Acetaminophen Mallinckrodt Zydus
10/25/2022 Daraprim Pyrimethamine Vyera Aurobindo
10/26/2022 Jevtana Kit Cabazitaxel Sanofi Accord Healthcare
10/26/2022 Cuyposa Glycopyrrolate Merz Alembic Pharms
10/26/2022 Lexiscan Regadenoson Astellas Eugia Pharma
10/26/2022 Banzel Rufinamide Eisai Aurobindo
10/26/2022 Narcan Naloxone HCl Bristol-Myers Squibb Accord Healthcare
10/27/2022 Florinef Fludrocortisone Acetate Casper Hikma
10/27/2022 Abilify Aripiprazole Bristol-Myers Squibb Rubicon
10/28/2022 Naproxen Naproxen Sodium Bionpharma Hetero Labs
10/28/2022 Lupron Leuprolide Acetate AbbVie Amneal
10/28/2022 Trimethoprim Trimethoprim Mayne Novitium Pharma
10/28/2022 Apriso Mesalamine Valeant Alembic Pharms
10/31/2022 Combigan Brimonidine Tartrate / Timolol Maleate AbbVie Akorn
10/31/2022 Velcade Bortezomib Sanofi Myla
10/31/2022 Zyvox Linezolid Pfizer Hetero
10/31/2022 Cupric Chloride Cupric Chloride Pfizer Exela Pharma
11/01/2022 Buphenyl Sodium Phenylbutyrate Horizon Glenmark
11/02/2022 Kenalog-40 Triamcinolone Acetonide Apothecon Mylan
11/02/2022 Toradol Ketorolac Tromethamine Roche Alembic Pharms
11/02/2022 Phenergan Promethazine HCl Mylan Annora Pharma
11/03/2022 Ammonia N 13 Ammonia N 13 Feinstein Univ Alahama Birmingham
11/03/2022 Bloxiverz Neostigmine Methylsulfate Exela Nivagen Pharms
11/03/2022 Cleocin T Clindamycin Phosphate Pfizer Amneal
11/03/2022 Lipitor Atorvastatin Calcium Pfizer Lepu Pharm
11/04/2022 Trileptal Oxcarbazepine Novartis Bionpharma
11/04/2022 Atropine Sulfate Atropine Sulfate Hospira Medefil
11/04/2022 Ziac Bisoprolol Fumarate / Hydrochlorothiazide Teva Cadila
11/04/2022 Amicar Aminocaproic Acid Akorn Annora Pharma
11/07/2022 Banzel Rufinamide Eisai Glasshouse Pharms
11/07/2022 Narcan Naloxone HCl Bristol-Myers Squib Baxter Healthcare
11/07/2022 Imdur Isosorbide Mononitrate Schering Plough Aurobindo
11/08/2022 Halcion Triazolam Pfizer Sandoz
11/09/2022 Nexavar Sorafenib Tosylate Bayer Yabao Pharm
11/09/2022 Denavir Penciclovir Mylan Teva
11/09/2022 Prozac Fluoxetine HCl Eli Lilly and Co Novitium Pharma
11/09/2022 Mexitil Mexiletine HCl Boehringer-Ingelheim Annora Pharma
11/10/2022 Dizac Diazepam Pharmacia and Upjohn Fresenius Kabi
11/10/2022 Cyclophosphamide Cyclophosphamide Hikma Alembic Pharms
11/14/2022 Firvanq Kit Vancomycin HCl Azurity Alkem Labs 
11/14/2022 Bystolic Nebivolol HCl AbbVie Mankind Pharma
11/15/2022 Bactroban Mupirocin Glaxo Amneal
11/15/2022 Cyanocobalamin Cyanocobalamin American Regent Sagent
11/15/2022 Keppra Levetiracetam UCB MSN
11/15/2022 Brovana Arformoterol Tartrate Sunovion Mankind Pharma
11/15/2022 Prolixin Fluphenazine HCl Bristol-Myers Squibb Sandoz
11/15/2022 Prozac Fluoxetine HCl Eli Lilly and Co Aptapharma
11/16/2022 Durezol Difluprednate Novartis Dr Reddy's Labs
11/16/2022 DDAVP Desmopressin Acetate Ferring Gland Pharma
11/17/2022 Potassium Chloride Potassium Chloride Genus Strides
11/17/2022 AmBisome Amphotericin B Astellas Eugia Pharma
11/17/2022 Gadavist Gadobutrol Bayer Hengrui Pharma
11/17/2022 Valcyte Valganciclovir HCl Hoffman LaRoche Aurobindo
11/18/2022 Haldol Haloperidol Ortho McNeil MSN
11/18/2022 Procardia XL Nifedipine Pfizer Pharmadax
11/18/2022 Procardia XL Nifedipine Pfizer Alembic Pharms
11/21/2022 Eryped Erythromycin Ethylsuccinate Azurity Cadila Pharms
11/22/2022 Compazine Prochlorperazine Edisylate GlaxoSmithKline Hikma
11/22/2022 Pepcid Famotidine Merck Zydus
11/22/2022 Mitomycin Mitomycin Bristol-Myers Squib Gland Pharma
11/23/2022 Ocuflox Ofloxacin AbbVie Mankind Pharma
11/23/2022 Lipitor Atorvastatin Calcium Pfizer Biocon Pharma
11/25/2022 Bloxiverz Neostigmine Methysulfate Exela Avet Lifesciences
11/25/2022 Rozerem Ramelteon Takeda Xiromed
11/25/2022 Perforomist Formoterol Fumarate Mylan Aucta
11/28/2022 Qudexy XR Topiramate Upsher Smith Labs Zydus
11/28/2022 Cuyposa Glycopyrrolate Merz Aspen
11/28/2022 Compazine Prochlorperazine Edisylate GlaxoSmithKline Amneal
11/28/2022 Actigall Ursodiol Teva Aurobindo
11/28/2022 Effexor XR Venlafaxine HCl Wyeth Unique
11/28/2022 Sinemet Carbidopa / Levodopa Organon Aurobindo
11/28/2022 Bentyl Dicyclomine HCl Allergan Corepharma
11/28/2022 Brovana Arformoterol Tartrate Lupin Slayback
11/29/2022 Pennsaid 2% Diclofenac Sodium Horizon Alembic Pharms
11/30/2022 Noxafil Posaconazole Merck Actavis
11/30/2022 Trileptal Oxcarbazepine Novartis Aucta
12/01/2022 Vivelle-Dot Estradiol Novartis Zydus
12/02/2022 Benicar Olmesartan Medoxomil Cosette Prinston
12/02/2022 Brevibloc Esmolol HCl Baxter HQ Spcecialty Pharma
12/02/2022 Tegretol XR Carbamazepine Novartis Riconpharma
12/06/2022 Viibryd Vilazodone HCl AbbVie Invagen Pharms
12/07/2022 Vivimusta Bendamustine HCl Slayback Dr Reddy's Labs
12/07/2022 Vivimusta Bendamustine HCl Slayback Accord Healthcare
12/07/2022 Vibramycin Doxycycline Hyclate Pfizer Par
12/08/2022 Rapaflo Silodosin AbbVie Zydus
12/08/2022 Noxafil Posaconazole Merck Hetero Labs
12/08/2022 Desonide Desonide Padagis Alembic
12/09/2022 Lyrica Pregabalin Pfizer Zydus
12/09/2022 Kenalog in Orabase Triamcinolone Acetonide Delcor Quagen
12/09/2022 Carnitor Levocarnitine Leadiant Novitium Pharma
12/12/2022 Hetlioz Tasimelteon Vanda Teva
12/12/2022 Combigan Brimonidine Tartrate / Timolol Maleate AbbVie Upsher Smith Labs
12/13/2022 Latuda Lurasidone HCl Sunovion Alkem Labs
12/13/2022 Alimta Pemetrexed Disodium Eli Lilly Hong Kong
12/13/2022 Perforomist Formoterol Fumarate Mylan Slayback
12/13/2022 Brevibloc Esmolol HCl Baxter Amneal
12/14/2022 Bentyl Dicyclomine HCl Allergan Rubicon
12/15/2022 Nimbex Cisatracurium Besylate AbbVie Piramal
12/16/2022 Cupric Sulfate Cupric Sulfate Abraxis American Regent
12/09/2022 Carnitor Levocarnitine Leadiant Novitium Pharma
12/12/2022 Hetlioz Tasimelteon Vanda Teva
12/12/2022 Combigan Brimonidine Tartrate / Timolol Maleate AbbVie Upsher Smith Labs
12/13/2022 Latuda Lurasidone HCl Sunovion Alkem Labs
12/13/2022 Alimta Pemetrexed Disodium Eli Lilly Hong Kong
12/13/2022 Perforomist Formoterol Fumarate Mylan Slayback
12/13/2022 Brevibloc Esmolol HCl Baxter Amneal
12/14/2022 Bentyl Dicyclomine HCl Allergan Rubicon
12/15/2022 Nimbex Cisatracurium Besylate AbbVie Piramal
12/16/2022 Cupric Sulfate Cupric Sulfate Abraxis American Regent
12/16/2022 Cardene Nicardipine HCl Chiesi Glenmark
12/16/2022 Lasix Furosemide Sanofi Mankind Pharma
12/20/2022 Hetlioz Tasimelteon Vanda Apotex
12/20/2022 Symmetrel Amantadine HCl Endo Humanwell Puracap
12/20/2022 Briviact Brivaracetam UCB Lupin
12/21/2022 Alphagan P Brimonidine Tartrate Allergan Apotex
12/21/2022 Synthroid Levothyroxine Sodium AbbVie Macleods
12/21/2022 Uptravi Selexipag Actelion Zydus
12/21/2022 Nicorette Nicotine Polacrilex GlaxoSmithKline Fertin Pharma
12/21/2022 Dobutrex Dobutamine HCl Eli Lilly and Co Hainan Poly
12/21/2022 Lincocin Lincomycin HCl Pfizer Hainan Poly
12/22/2022 Tecfidera Dimethyl Fumarate Biogen Aurobindo
12/22/2022 Faslodex Fulvestrant AstraZeneca Alembic Pharms
12/22/2022 Noxafil Posaconazole Merck Amneal
12/22/2022 Arranon Nelarabine Novartis Dr Reddy's Labs
12/23/2022 Ranexa Ranolazine Gilead Aurobindo
12/23/2022 Revatio Sildenafil Citrate Viatris Aurobindo
12/23/2022 CellCept Mycophenolate Mofetil HCl Roche Steriscience
12/23/2022 Cubicin Daptomycin Merck Aspiro
12/27/2022 Vesicare Solifenacin Succinate Astellas Aurobindo
12/27/2022 BiCNU Carmustine Avet Accord Healthcare
12/27/2022 Zinc Sulfate Zinc Sulfate Fresenius Kabi Fresenius Kabi
12/27/2022 Bentyl Dicyclomine HCl Allergan Twi
12/28/2022 Halcion Triazolam Pfizer Zydus
12/29/2022 Keveyis Dichlorphenamide Torrent Torrent
12/30/2022 Potassium Chloride Potassium Chloride Genus Guardian Drug
12/30/2022 Vidaza Azacitidine Celgene Eugia Pharma
12/30/2022 Minipress Prazosin HCl Pfizer Mankind Pharma

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