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 |
|---|---|---|---|---|
| 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 |
