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