Abbreviated New Drug Application and 505(b)(2) Application Approvals
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 | ANDA # |
| 07/01/2025 | Vibramycin | Doxycycline Hyclate | Pfizer | Dr. Reddy's Labs | 218753 |
| 07/02/2025 | Cardizem SR | Diltiazem HCl | Biovail | Novast Labs | 218032 |
| 07/02/2025 | Furadantin | Nitrofurantoin | Casper | Annora | 219495 |
| 07/03/2025 | Belrapzo | Bendamustine HCl | Eagle | Dr. Reddy's Labs | 219014 |
| 07/03/2025 | Indocin | Indomethacin | Zyla Life Sciences | Annora | 216905 |
| 07/03/2025 | Halaven | Eribulin Mesylate | Esai | Dr. Reddy's Labs | 217473 |
| 07/03/2025 | Nizoral | Ketoconazole | Janssen | Esjay | 219129 |
| 07/07/2025 | Maganese Chloride | Manganese Chloride | Hospira | Fresenius Kabi | 217583 |
| 07/07/2025 | Relpax | Eletriptan Hydrobromide | Upjohn | Annora | 219143 |
| 07/08/2025 | Selenious Acid | Selenious Acid | American Regent | Gland | 219629 |
| 07/09/2025 | Tamiflu | Oseltamivir Phosphate | Roche | Shandong | 217274 |
| 07/09/2025 | Pepcid | Famotidine | Salix | Aurobindo | 219091 |
| 07/09/2025 | Miacalcin | Calcitonin Salmon | Mylan | Sagent | 219196 |
| 07/09/2025 | MetroCream | Metronidazole | Galderma Labs | Aurobindo | 219295 |
| 07/09/2025 | Ablysinol | Alcohol | BPI Labs | Ingenus | 219569 |
| 07/10/2025 | Retin-A | Tretinoin | Bausch | Encube | 217831 |
| 07/11/2025 | Trileptal | Oxcarbazepine | Novartis | Macleods | 207300 |
| 07/11/2025 | Fycompa | Perampanel | Catalyst | MSN | 218152 |
| 07/11/2025 | Potassium Chloride | Potassium Chloride | Genus | Guardian Drug | 219009 |
| 07/14/2025 | Celebrex | Celecoxib | Upjohn | Zydus | 205938 |
| 07/14/2025 | Pataday Once Daily Relief | Olopatadine HCl | Alcon Labs | FDC | 217051 |
| 07/15/2025 | Imitrex | Sumatriptan Succinate | GlaxoSmithKline | Ipca Labs | 206019 |
| 07/15/2025 | Namzaric | Donepezil HCl / Memantine HCl | AbbVie | Macleods | 208672 |
| 07/15/2025 | Rapamune | Sirolimus | PF Prism | Rising | 215116 |
| 07/15/2025 | Lexapro | Escitalopram Oxalate | AbbVie | Ascent | 215177 |
| 07/15/2025 | Namzaric | Donepezil HCl / Memantine HCl | AbbVie | Xiamen LP | 216901 |
| 07/16/2025 | Entresto | Sacubitril / Valsartan | Novartis | Novugen | 213611 |
| 07/16/2025 | Entresto | Sacubitril / Valsartan | Novartis | MSN | 213748 |
| 07/16/2025 | Sertraline HCl | Sertraline HCl | Almatica | Zenara | 218853 |
| 07/17/2025 | Entresto | Sacubitril / Valsartan | Novartis | Hetero | 213668 |
| 07/17/2025 | Nicorette | Nicotine Polacrilex | Haleon | Dr. Reddy's Labs | 215276 |
| 07/17/2025 | Lasix | Furosemide | Validus | Aurobindo | 218831 |
| 07/17/2025 | Apresoline | Hydralazine HCl | Novartis | Baxter | 219797 |
| 07/18/2025 | Tribenzor | Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil | Cosette | Macleods | 207088 |
| 07/18/2025 | Cancidas | Caspofungin Acetate | Merck | Hangzhou Zhongmei | 216506 |
| 07/21/2025 | Selenious Acid | Selenious Acid | American Regent | Cipla | 218661 |
| 07/22/2025 | Prezista | Darunavir | Janssen | Mylan | 202136 |
| 07/22/2025 | Glucagon | Glucagon | Eli Lilly | Lupin | 214457 |
| 07/22/2025 | Victoza | Liraglutide | Novo Nordisk | Lupin | 215421 |
| 07/22/2025 | Potassium Chloride | Potassium Chloride | Genus | Taro | 218960 |
| 07/23/2025 | Ancobon | Flucytosine | Bausch | Laurus | 218005 |
| 07/24/2025 | Ativan | Lorazepam | Bausch | Graviti | 218597 |
| 07/24/2025 | Pepcid | Famotidine | Salix | MSN | 219863 |
| 07/25/2025 | Niaspan | Niacin | AbbVie | MPP Pharma | 207726 |
| 07/25/2025 | Benicar HCT | Hydrochlorothiazide / Olmesartan Medoxomil | Cosette | Hetero | 209199 |
| 07/25/2025 | Aldactone | Spironolactone | Pfizer | Annora | 217761 |
| 07/25/2025 | Tegretol-XR | Carbamazepine | Novartis | Alembic | 219939 |
| 07/29/2025 | Arazio | Tazarotene | Bausch | Padagis Israel | 215393 |
| 07/29/2025 | Xylocaine Viscous | Lidocaine HCl | Fresenius Kabi | Aurobindo | 219759 |
| 07/30/2025 | Luvox CR | Fluvoxamine Maleate | Jazz | Annora | 217024 |
| 07/30/2025 | Alphagan P | Brimonidine Tartrate | AbbVie | Upsher Smith | 217599 |
| 07/30/2025 | ProvayBlue | Methylene Blue | Provepharm | Xiromed | 219363 |
| 07/31/2025 | Xarelto | Rivaroxaban | Janssen | ScieGen | 218117 |
| 08/04/2025 | Aptiom | Eslicarbazepine Acetate | Sumitomo | Jubilant | 211219 |
| 08/04/2025 | Vigamox | Moxifloxacin HCl | Harrow Eye | FDC | 219475 |
| 08/05/2025 | Bumex | Bumetanide | Validus | Jubilant | 212470 |
| 08/05/2025 | Bridion | Sugammadex Sodium | Merck | Fisiopharma | 214279 |
| 08/05/2025 | Halaven | Eribulin Mesylate | Esai | Xiling Lab | 218142 |
| 08/05/2025 | Vibramycin | Doxycycline Hyclate | Pfizer | Aspiro | 218888 |
| 08/06/2025 | Silenor | Doxepin HCl | Currax | Taro | 219058 |
| 08/06/2025 | Vascepa | Icosapent Ethyl | Amarin | Xiamen LP | 219156 |
| 08/07/2025 | Ascor | Ascorbic Acid | McGuff | Fresenius Kabi | 217131 |
| 08/07/2025 | Ketalar | Ketamine HCl | PH Health | Pharmather | 217858 |
| 08/07/2025 | Motegrity | Prucalopride Succinate | Takeda | Zydus | 218056 |
| 08/07/2025 | Priolosec OTC | Omeprazole Magnesium | AstraZeneca | Marksans | 218829 |
| 08/07/2025 | Neurontin | Gabapentin | Viatris | Stallion Labs | 219319 |
| 08/08/2025 | Venofer | Iron Sucrose | American Regent | Int'l Medication | 208977 |
| 08/08/2025 | Vfend | Voriconazole | PF Prism | Hetero | 211598 |
| 08/08/2025 | Venofer | Iron Sucrose | American Regent | Sandoz | 212340 |
| 08/08/2025 | Venofer | Iron Sucrose | American Regent | Mylan | 212559 |
| 08/08/2025 | Olumiant | Baricitinib | Eli Lilly | MSN | 217585 |
| 08/08/2025 | Sodium Acetate | Sodium Acetate | Hospira | Amneal | 218469 |
| 08/08/2025 | Cardizem | Diltiazem HCl | Bausch | Zydus | 219253 |
| 08/11/2025 | Esbriet | Pirfenidone | Genentech | Aurobindo | 212596 |
| 08/11/2025 | Kengreal | Cangrelor | Chiesi | Gland | 213551 |
| 08/11/2025 | Emflaza | Deflazacort | PTC Therapeutics | Upsher Smith | 216992 |
| 08/11/2025 | Xarelto | Rivaroxaban | Janssen | Indoco | 218445 |
| 08/11/2025 | Norepinephrine Bitartrate in 5% Dextrose | Norepinephrine Bitartrate | Baxter | Sagent | 219692 |
| 08/12/2025 | Depakote | Divalproex Sodium | AbbVie | Mankind | 217358 |
| 08/13/2025 | Apriso | Mesalamine | Salix | Annora | 219864 |
| 08/14/2025 | Retin-A | Tretinoin | Bausch | Alembic | 218399 |
| 08/15/2025 | Flonase Allergy Relief | Fluticasone Propionate | Haleon | Rubicon | 219060 |
| 08/18/2025 | Opsumit | Macitentan | Actelion | Alembic | 211128 |
| 08/19/2025 | Abraxane | Paclitaxel | Bristol Myers Squibb | Mylan | 217877 |
| 08/19/2025 | Lysteda | Tranexamic Acid | Amring | Bionpharma | 219123 |
| 08/19/2025 | Xeljanz XR | Tofacitinib Citrate | Pfizer | Ajanta | 219542 |
| 08/20/2025 | Opsumit | Macitentan | Actelion | MSN | 211136 |
| 08/20/2025 | Benicar HCT | Hydrochlorothiazide / Olmesartan Medoxomil | Cosette | Zhejiang Nuode | 214427 |
| 08/20/2025 | Nicardipine HCl | Nicardipine HCl | Hikma | Nanjing King-Friend | 216819 |
| 08/21/2025 | Narcan | Naloxone HCl | Adapt | Sterinova | 214211 |
| 08/22/2025 | Denavir | Penciclovir | Mylan | Amneal | 214100 |
| 08/22/2025 | Diphenhydramine HCl | Diphenhydramine HCl | West-Ward | Micro Labs | 219845 |
| 08/25/2025 | Sodium Bicarbonate | Sodium Bicarbonate | Abbot | Fresenius Kabi | 206688 |
| 08/25/2025 | Sprycel | Dasatinib | Bristol Myers Squibb | Lupin | 214350 |
| 08/26/2025 | Opsumit | Macitentan | Actelion | Sun | 211123 |
| 08/27/2025 | Sprycel | Dasatinib | Bristol Myers Squibb | Teva | 211094 |
| 08/27/2025 | Saxenda | Liraglutide | Novo | Teva | 214568 |
| 08/28/2025 | Namenda XR | Memantine HCl | AbbVie | Macleods | 206310 |
| 08/28/2025 | Amicar | Aminocaproic Acid | Epic | Gen Ilac | 215374 |
| 08/29/2025 | Cambia | Diclofenac Potassium | Asio Holdings | Umedica | 217010 |
| 09/02/2025 | Risperdal Consta | Risperidone | Janssen | Nanomi | 211220 |
| 09/02/2025 | Risperdal Consta | Risperidone | Janssen | Amneal | 218586 |
| 09/02/2025 | Primacor In Dextrose | Milrinone Lactate | Sanofi | Caplin | 219170 |
| 09/02/2025 | Qudexy XR | Topiramate | Upsher Smith | Ajanta | 219564 |
| 09/03/2025 | Kuvan | Sapropterin Dihydrochloride | Biomarin | Hopewell | 216432 |
| 09/03/2025 | Geodon | Ziprasidone Mesylate | Viatris | Steriscience | 217595 |
| 09/04/2025 | Invega | Paliperidone | Janssen | Everest Lifesciences | 218755 |
| 09/04/2025 | Votrient | Pazopanib HCl | Novartis | Torrent | 219922 |
| 09/08/2025 | Jadenu Sprinkle | Deferasirox | Novartis | Aurobindo | 215137 |
| 09/08/2025 | Phytonadione | Phytonadione | Int'l Medication | Alembic | 216444 |
| 09/08/2025 | Compazine | Prochlorperazine Maleate | GlaxoSmithKline | Aurobindo | 218734 |
| 09/10/2025 | Xyrem | Sodium Oxybate | Jazz | Amneal | 203631 |
| 09/10/2025 | Potassium Chloride | Potassium Chloride | Genus | Macleods | 218733 |
| 09/11/2025 | Potassium Phosphates | Potassium Phosphate, Dibasic / Potassium Phosphate, Monobasic | Fresenius Kabi | Hospira | 217459 |
| 09/15/2025 | Glucagon | Glucagon | Eli Lilly | Cipla | 218813 |
| 09/15/2025 | Neoral | Cyclosporine | Novartis | Qilu | 219049 |
| 09/15/2025 | Colestid | Colestipol HCl | Pfizer | Carnegie | 220012 |
| 09/16/2025 | Revlimid | Lenalidomide | Bristol Myers Squibb | Lupin | 214398 |
| 09/18/2025 | Sodium Acetate | Sodium Acetate | Hospira | Somerset | 219826 |
| 09/18/2025 | Campral | Acamprosate Calcium | Forest | Bionpharma | 219904 |
| 09/19/2025 | Endometrin | Progesterone | Ferring | Xiromed | 218391 |
| 09/19/2025 | Gralise | Gabapentin | Almatica | Sciegen | 218491 |
| 09/19/2025 | Cozaar | Losartan Potassium | Organon | Graviti | 219859 |
| 09/19/2025 | Imodium A-D | Loperamide HCl | Kenvue | Bionpharma | 220100 |
| 09/22/2025 | Lumigan | Bimatoprost | AbbVie | Amneal | 217289 |
| 09/23/2025 | Exelon | Rivastigmine | Sandoz | Yichang Humanwell | 215445 |
| 09/23/2025 | Normodyne | Labetalol HCl | Schering | Macleods | 217949 |
| 09/23/2025 | Erythromycin | Erythromycin | Azurity | Abon Pharms | 219691 |
| 09/24/2025 | Paxil CR | Paroxetine HCl | Apotex | Alembic | 217280 |
| 09/25/2025 | Xarelto | Rivaroxaban | Janssen | Lupin | 218195 |
| 09/29/2025 | Calcium Chloride | Calcium Chloride | Hospira | Square Pharms | 217463 |
| 09/30/2025 | Mifeprex | Mifepristone | Danco Labs | Evita Solutions | 216616 |
| 09/30/2025 | Casporyn HC | Hydrocortisone / Neomycin Sulfate / Polymyxin B Sulfate | Casper | Amneal | 217735 |
| 09/30/2025 | Plan B One-Step | Levonorgestrel | FDN Consumer | Annora | 219102 |
