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 | ANDA # |
| 01/02/2025 | Myrbetriq | Mirabegron | APGDI (Astellas) | Apotex | 209434 |
| 01/02/2025 | Amitiza | Lubiprostone | Sucampo Pharma | Ascent Pharms | 218640 |
| 01/03/2025 | Phytonadione | Phytonadione | Int'l Medication | Cipla | 214966 |
| 01/03/2025 | Clolar | Clofarabine | Genzyme | ScinoPharm Taiwan | 216233 |
| 01/06/2025 | Tecfidera | Dimethyl Fumarate | Biogen | Torrent | 210390 |
| 01/07/2025 | Exforge HCT | Amlodipine Besylate / Hydrochlorothiazide / Valsartan | Novartis | Macleods | 207299 |
| 01/07/2025 | D.H.E. 45 | Dihydroergotamine Mesylate | Bausch Health | Baxter Healthcare | 216747 |
| 01/07/2025 | Nexium | Esomeprazole Magnesium | AstraZeneca | Cipla | 217714 |
| 01/07/2025 | Relafen | Nabumetone | SmithKline Beecham | Novitium Pharma | 219118 |
| 01/08/2025 | Entresto | Sacubitril / Valsartan | Novartis | Lupin | 213808 |
| 01/08/2025 | Lonsurf | Tipiracil Hydrochloride / Trifluridine | Taiho Oncology | MSN | 214024 |
| 01/08/2025 | Nexium IV | Esomeprazole Sodium | AstraZeneca | Yangtze | 214046 |
| 01/08/2025 | Lopressor HCT | Hydrochlorothiazide / Metoprolol Tartrate | Validus Pharms | Senores Pharms | 215789 |
| 01/10/2025 | Afinitor Disperz | Everolimus | Novartis Pharm | Amneal | 218863 |
| 01/13/2025 | Latuda | Lurasidone HCl | Sunovion Pharms | Torrent | 208055 |
| 01/13/2025 | Stivarga | Regorafenib | Bayer Healthcare | Actavis | 209728 |
| 01/13/2025 | Tegretol-XR | Carbamazepine | Novartis | Torrent | 212524 |
| 01/13/2025 | Entresto | Sacubitril / Valsartan | Novartis | Dr. Reddy's | 213627 |
| 01/13/2025 | Rexulti | Brexpiprazole | Otsuka | Alembic | 213683 |
| 01/13/2025 | Retin-A | Tretinoin | Bausch | Aurobindo | 218246 |
| 01/13/2025 | THEO-DUR | Theophylline | Schering Plough | Ajanta | 218401 |
| 01/13/2025 | Mesnex | Mesna | Baxter Healthcare | Riconpharma | 218871 |
| 01/14/2025 | Furadantin | Nitrofurantoin | Casper Pharma | Appco | 208909 |
| 01/14/2025 | Tegretol-XR | Carbamazepine | Novartis | Alkem Labs | 217277 |
| 01/14/2025 | Sinemet | Carbidopa / Levodopa | Organon | Ascent | 218939 |
| 01/14/2025 | Atrovent | Ipratropium Bromide | Boehringer Ingelheim | Rubicon | 219222 |
| 01/15/2025 | Micardis | Telmisartan | Boehringer Ingelheim | Macleods | 203986 |
| 01/15/2025 | Pristiq | Desvenlafaxine Succinate | PF Prism | Macleods | 211427 |
| 01/16/2025 | Emerphed | Ephedrine Sulfate | Nexus | Gland Pharma | 218211 |
| 01/16/2025 | Tegretol-XR | Carbamazepine | Novartis | Yichang Humanwell | 219072 |
| 01/16/2025 | Protonix | Pantoprazole Sodium | Wyeth Pharms | Graviti Pharms | 219087 |
| 01/16/2025 | Levetiracetam | Levetiracetam | HQ Specialty | Caplin | 219562 |
| 01/17/2025 | Promacta | Eltrombopag Olamine | Novartis | Hetero Labs | 206788 |
| 01/17/2025 | Advil Dual Action with Acetaminophen | Acetaminophen / Ibuprofen | Haleon | Strides Pharma | 217241 |
| 01/21/2025 | Prezista | Darunavir | Janssen | Annora Pharma | 216168 |
| 01/21/2025 | Steglatro | Ertugliflozin | Merck Sharp & Dohme | Hikma | 216842 |
| 01/21/2025 | Edarbyclor | Azilsartan Kamedoxomil / Chlorthalidone | Azurity | Alkem | 217490 |
| 01/22/2025 | Nymalize | Nimodipine | Azurity | Alkem | 213409 |
| 01/22/2025 | Cambia | Diclofenac Potassium | Assertio | Torrent | 215891 |
| 01/22/2025 | Stromectol | Ivermectin | Merck Sharp & Dohme | Rubicon | 215922 |
| 01/23/2025 | Provayblue | Methylene Blue | Provepharm | Meitheal | 217380 |
| 01/23/2025 | Aldactone | Spironolactone | Pfizer | Graviti Pharms | 219494 |
| 01/24/2025 | Potassium Phosphates | Potassium Phosphate, Dibasic / Potassium Phosphate, Monobasic | Fresenius Kabi | Cipla | 217892 |
| 01/27/2025 | Vytorin | Ezetimibe / Simvastatin | Organon | Torrent | 209461 |
| 01/27/2025 | Nexavar | Sorafenib Tosylate | Bayer Healthcare | Apotex | 212228 |
| 01/27/2025 | Astepro | Azelastine HCl | Bayer Healthcare | Aurobindo Pharma | 216561 |
| 01/27/2025 | Oracea | Doxycycline | Galderma Labs | Prinston | 217098 |
| 01/27/2025 | Atrovent | Ipratropium Bromide | Boehringer Ingelheim | Lupin | 217886 |
| 01/27/2025 | Oxaliplatin | Oxaliplatin | Teva | Hetero Labs | 217925 |
| 01/27/2025 | Vigamox | Moxifloxacin HCl | Harrow Eye | Mankind | 217988 |
| 01/28/2025 | Pradaxa | Dabigatran Etexilate Mesylate | Boehringer Ingelheim | Dr. Reddy's | 208048 |
| 01/28/2025 | Bystolic | Nebivolol HCl | Allergan | Macleods | 212661 |
| 01/28/2025 | Dyazide | Hydrochlorothiazide / Triamterene | GlaxoSmithKline | Macleods | 214611 |
| 01/28/2025 | Afinitor Disperz | Everolimus | Novartis | Natco | 217640 |
| 01/28/2025 | Lyrica CR | Pregabalin | Upjohn | HQ Pharma | 217857 |
| 01/28/2025 | Venlafaxine HCl | Venlafaxine HCl | Osmotica Pharm | Torrent | 218180 |
| 01/29/2025 | Lotemax | Loteprednol Etabonate | Bausch and Lomb | Padagis | 215204 |
| 01/29/2025 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Granules | 218987 |
| 01/30/2025 | Perforomist | Formoterol Fumarate | Viatris Specialty | Dr. Reddy's | 215907 |
| 01/30/2025 | Buprenex | Buprenorphine HCl | Indivior | Somerset Therapeutics | 219302 |
| 01/31/2025 | Revlimid | Lenalidomide | Bristol-Myers Squibb | Amneal | 216213 |
| 01/31/2025 | Levophed | Norepinephrine Bitartrate | Hospira | Aspiro | 219163 |
| 02/03/2025 | Pradaxa | Dabigatran Etexilate Mesylate | Boehringer Ingelheim | Mylan | 208067 |
| 02/03/2025 | Alinia | Nitazoxanide | Romark Labs | Zenara | 214844 |
| 02/03/2025 | Brovana | Arformoterol Tartrate | Lupin | Aucta | 218380 |
| 02/03/2025 | Renagel | Sevelamer HCl | Genzyme | Navinta | 218966 |
| 02/04/2025 | Renexa | Ranolazine | Menarini | Torrent | 210407 |
| 02/04/2025 | Pronestyl | Procainamide HCl | Apothecon | Caplin | 218674 |
| 02/05/2025 | Tracleer | Bosentan | Actelion | Natco Pharma | 213154 |
| 02/05/2025 | Tapazole | Methimazole | King Pharms | Square Pharms | 218830 |
| 02/06/2025 | Adrucil | Fluorouracil | Pharmacia and Upjohn | Kindos | 215699 |
| 02/06/2025 | Epinephrine | Epinephrine | BPI Labs | Gland Pharma | 219239 |
| 02/07/2025 | Venlafaxine HCl | Venlafaxine HCl | Osmotica Pharm | Abon Pharms | 217841 |
| 02/07/2025 | Atrovent | Ipratropium Bromide | Boehringer Ingelheim | Lupin | 217912 |
| 02/10/2025 | Rapaflo | Silodosin | AbbVie | Torrent | 210396 |
| 02/10/2025 | Selenious Acid | Selenious Acid | American Regent | Fresenius Kabi | 218779 |
| 02/11/2025 | Benztropine Mesylate | Benztropine Mesylate | Lannett | Quagen | 212694 |
| 02/11/2025 | Trusopt | Dorzolamide HCl | Merck Sharp & Dohme | Somerset Therapeutics | 215004 |
| 02/11/2025 | Succinylcholine Chloride | Succinylcholine Chloride | Hikma | Fresenius Kabi | 217884 |
| 02/11/2025 | Durezol | Difluprednate | Sandoz | Upsher Smith | 218191 |
| 02/11/2025 | Perforomist | Formoterol Fumarate | Viatris Specialty | Deva Holding | 218308 |
| 02/11/2025 | Prohance | Gadoteridol | Bracco | Hainan Poly | 218749 |
| 02/12/2025 | Efudex | Fluorouracil | Entrovis | Encube | 216942 |
| 02/12/2025 | Prograf | Tacrolimus | Astellas | Nexus | 217108 |
| 02/12/2025 | Mucomyst | Acetylcysteine | Apothecon | Somerset Therapeutics | 219194 |
| 02/14/2025 | Azor | Amlodipine Besylate / Olmesartan Medoxomil | Cosette | Hetero Labs | 209591 |
| 02/14/2025 | Eliquis | Apixaban | Bristol-Myers Squibb | Impax | 209810 |
| 02/14/2025 | Sutent | Sunitinib Malate | CPPI CV | MSN | 214824 |
| 02/14/2025 | Biorphen | Phenylephrine HCl | Dr. Reddy's | Somerset Therapeutics | 215617 |
| 02/18/2025 | Asacol HD | Mesalamine | AbbVie | Amneal | 215067 |
| 02/18/2025 | Cosopt PF | Dorzolamide HCl / Timolol Maleate | Thea Pharma | IdentiRX | 216308 |
| 02/19/2025 | Tasigna | Nilotinib D-Tartrate | Novartis | Cipla | N218922 |
| 02/19/2025 | Invega | Paliperidone | Janssen | Dr. Reddy's | 205559 |
| 02/20/2025 | Duexis | Famotidine / Ibuprofen | Horizen Medicines | Zydus | 218684 |
| 02/20/2025 | Selenious Acid | Selenious Acid | American Regent | Sun Pharm | 219547 |
| 02/21/2025 | Ctexli | Chenodiol | Mirium | Mirum | N219488 |
| 02/21/2025 | Lyrica | Pregabalin | Upjohn | Torrent | 206942 |
| 02/21/2025 | Vibramycin | Doxycycline Hyclate | Pfizer | Precision Dose | 217078 |
| 02/21/2025 | Anectine / Quelicin | Succinylcholine Chloride | Sandoz/Hospira | Fresenius Kabi | 217885 |
| 02/21/2025 | CaroSpir | Spironolactone | CMP Dev. | Hetero Labs | 218085 |
| 02/24/2025 | Rexulti | Brexpiprazole | Otsuka | Apotex | 213731 |
| 02/24/2025 | Indocin | Indomethacin | Zyla Life Sciences | Amneal | 215399 |
| 02/24/2025 | Thiamine HCl | Thiamine HCl | Fresenius Kabi | Gland Pharma | 217800 |
| 02/24/2025 | Noxafil | Posaconazole | Merck Sharp & Dohme | MSN | 218434 |
| 02/24/2025 | Lucemyra | Lofexidine HCl | US WorldMeds | MSN | 218699 |
| 02/25/2025 | Combigan | Brimonidine Tartrate / Timolol Maleate | AbbVie | Caplin | 219093 |
| 02/26/2025 | Migranal | Dihydroergotamine Mesylate | Bausch | Aggrega | 215228 |
| 02/26/2025 | Lidex | Fluocinonide | Alvogen | Quagen | 216389 |
| 02/26/2025 | Purixan | Mercaptopurine | Nova Labs | Hikma | 216418 |
| 02/27/2025 | Eliquis | Apixaban | Bristol-Myers Squibb | Macleods | 210067 |
| 02/27/2025 | Renvela | Sevelamer Carbonate | Genzyme | Torrent | 215909 |
| 02/27/2025 | Retin-A | Tretinoin | Valeant | Aurobindo | 218245 |
| 02/27/2025 | Bumex | Bumetanide | Validus | Aspiro | 218746 |
| 02/28/2025 | Claritin | Loratadine | Bayer Healthcare | Catalent | 215127 |
| 02/28/2025 | Allegra | Fexofenadine HCl | Chattem Sanofi | Contract Pharmacal | 219032 |
| 02/28/2025 | Pataday | Olopatadine HCl | Alcon Labs | Glenmark | 219557 |
| 03/03/2025 | Xarelto | Rivaroxaban | Janssen | Lupin | 208555 |
| 03/03/2025 | Xarelto | Rivaroxaban | Janssen | Taro | 208557 |
| 03/03/2025 | Sprycel | Dasatinib | Bristol-Myers Squibb | Dr. Reddy's | 213383 |
| 03/03/2025 | Tamiflu | Oseltamivir Phosphate | Roche | Jubilant | 213695 |
| 03/03/2025 | Revlimid | Lenalidomide | Bristol-Myers Squibb | Biocon Pharma | 215759 |
| 03/03/2025 | Sprycel | Dasatinib | Bristol-Myers Squibb | Biocon Pharma | 217217 |
| 03/03/2025 | Retin-A | Tretinoin | Valeant | Encube | 217587 |
| 03/03/2025 | Retin-A | Tretinoin | Bausch | Encube | 217588 |
| 03/03/2025 | Serax | Oxazepam | Alpharma | Leading | 218261 |
| 03/03/2025 | Micardis HCT | Hydrochlorothiazide / Telmisartan | Boehringer Ingelheim | Mankind Pharma | 218406 |
| 03/03/2025 | Sprycel | Dasatinib | Brystol-Myers Squibb | Zydus | 218719 |
| 03/04/2025 | Vesicare | Solifenacin Succinate | Astellas | Torrent | 209424 |
| 03/04/2025 | Halaven | Eribulin Mesylate | Esai | Chia Tai Tianqing | 218743 |
| 03/05/2025 | Nexium | Esomeprazole Magnesium | AstraZeneca | Torrent | 212651 |
| 03/05/2025 | Nexium | Esomeprazole Magnesium | AstraZeneca | Torrent | 212652 |
| 03/05/2025 | Levothyroxine Sodium | Levothyroxine Sodium | Fresenius Kabi | Steriscience | 216729 |
| 03/05/2025 | Divigel | Estradiol | Vertical Pharms | Encube | 218507 |
| 03/06/2025 | Revatio | Sildenafil Citrate | Viatris | Jubilant | 202954 |
| 03/07/2025 | Brovana | Arformoterol Tartrate | Lupin | Micro Labs | 218555 |
| 03/07/2025 | Nizoral | Ketoconazole | Janssen | Zydus | 218559 |
| 03/10/2025 | Folotyn | Pralatrexate | Acrotech Biopharma | Dr. Reddy's | 206183 |
| 03/10/2025 | Hiprex | Methenamine Hippurate | Esjay | Zydus | 219661 |
| 03/11/2025 | Akovaz | Ephedrine Sulfate | Exela/Nexus | Fresenius Kabi | 218271 |
| 03/12/2025 | Proventil | Albuterol Sulfate | Schering | Ritedose | 218386 |
| 03/12/2025 | Kenalog-10 | Triamcinolone Acetonide | Apothecon | Dr. Reddy's | 218773 |
| 03/13/2025 | Arbli | Losartan | Scienture | Scienture | N218772 |
| 03/13/2025 | Fosrenol | Lanthanum Carbonate | Takeda | Alkem | 202329 |
| 03/13/2025 | Riomet | Metformin HCl | Ranbaxy | Annora Pharma | 215008 |
| 03/13/2025 | Buspar | Buspirone HCl | Bristol-Myers Squibb | Epic Pharma | 218628 |
| 03/14/2025 | Viberzi | Eluxadoline | AbbVie | Zydus | 213522 |
| 03/14/2025 | Mucomyst | Acetylcysteine | Apothecon | Conba | 214177 |
| 03/14/2025 | Chronulac | Lactulose | Sanofi | Pai | 217914 |
| 03/14/2025 | Zavesca | Miglustat | Actelion | Navinta | 219111 |
| 03/17/2025 | Erleada | Apalutamide | Janssen Biotech | Zydus | 217113 |
| 03/17/2025 | Lumigan | Bimatoprost | AbbVie | Mankind Pharma | 218196 |
| 03/17/2025 | Kytril | Granisetron HCl | Hoffmann La Roche | Intra Sana Labs | 219282 |
| 03/18/2025 | Trilafon | Perphenazine | Schering | Jubilant | 213694 |
| 03/18/2025 | Emflaza | Deflazacort | PTC Therap | Sun Pharm | 217741 |
| 03/19/2025 | Entadfi | Finasteride / Tadalafil | Blue Water Biotech | Novitium | 218499 |
| 03/20/2025 | Durezol | Difluprednate | Sandoz | Mylan | 212566 |
| 03/21/2025 | Vancomycin HCl | Vancomycin HCl | Mylan | Gland | 218140 |
| 03/21/2025 | Levophed | Norepinephrine Bitartrate | Hospira | Biocon Pharma | 219443 |
| 03/21/2025 | Naropin | Ropivacaine HCl | Fresenius Kabi | Anthea Pharma | 219883 |
| 03/24/2025 | Cardizem SR | Diltiazem HCl | Biovail Labs | AMTA | 219073 |
| 03/25/2025 | Ztlido | Lidocaine | Scilex Pharms | Aveva | 217221 |
| 03/25/2025 | Pepcid | Famotidine | Bausch Health | Beximco Pharms | 218631 |
| 03/26/2025 | Draximage DTPA | Technetium Tc-99M Pentetate Kit | Jubilant | Curium | 215146 |
| 03/26/2025 | Zinecard | Dexrazoxane HCl | Pfizer | MSN | 216748 |
| 03/26/2025 | Theophylline | Theophylline | Bausch | Ajanta | 218401 |
| 03/27/2025 | Oracea | Doxycycline | Galderma | Macleods | 210381 |
