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 # |
| 04/02/2025 | Liraglutide | Liraglutide | Novo Nordisk | Nanjing King-Friend | 218115 |
| 04/02/2025 | Acetaminophen | Acetaminophen | B Braun Medical | Gland | 219215 |
| 04/02/2025 | Xylocaine | Lidocaine HCl | Fresenius Kabi | Anthea Pharma | 219535 |
| 04/03/2025 | Mycamine | Micafungin Sodium | Astellas | Qilu Pharm Hainan | 219273 |
| 04/03/2025 | Bumex | Bumetanide | Validus Pharms | Mankind | 219291 |
| 04/03/2025 | Colazal | Balsalazide Disodium | Valeant Pharms | Carnegie | 219422 |
| 04/04/2025 | Aczone | Dapsone | AbbVie | Aurobindo | 218457 |
| 04/07/2025 | Aubagio | Teriflunomide | Sanofi Aventis | Concord Biotech | 218663 |
| 04/08/2025 | Dymista | Azelastine HCl / Fluticasone Propionate | Mylan | Teva | 208436 |
| 04/08/2025 | Cuvposa | Glycopyrrolate | Merz Pharms | MSN | 216084 |
| 04/08/2025 | Chantix | Varenicline Tartrate | PF Prism | Shilpa | 216615 |
| 04/08/2025 | Emflaza | Deflazacort | PTC Therapeutics | Zydus | 219254 |
| 04/09/2025 | Potassium Chloride | Potassium Chloride | Genus Lifesciences | Ascent Pharms | 211992 |
| 04/09/2025 | Zortress | Everolimus | Novartis | Biocon Pharma | 216140 |
| 04/09/2025 | Diclofenac Sodium | Diclofenac Sodium | Horizon | Encube | 217646 |
| 04/09/2025 | Demser | Metyrosine | Bausch | Cerovene | 218620 |
| 04/10/2025 | Lopressor | Metoprolol Tartrate | Rubicon | Rubicon | N219373 |
| 04/10/2025 | Xarelto | Rivaroxaban | Janssen | Aurobindo Pharma | 208544 |
| 04/10/2025 | Abraxane | Paclitaxel | Bristol Myers Squibb | Cipla | 209657 |
| 04/11/2025 | Jadenu | Deferasirox | Novartis | Jubilant | 211660 |
| 04/11/2025 | Kenalog-40 | Triamcinolone Acetonide | Apothecon | Dr. Reddy's Labs | 218421 |
| 04/14/2025 | Carafate | Sucralfate | AbbVie | Padagis | 211780 |
| 04/14/2025 | Gleevec | Imatinib Mesylate | Novartis | Hetero | 212975 |
| 04/14/2025 | Zyloprim | Allopurinol | Casper Pharma | Aurobindo | 215091 |
| 04/14/2025 | Zinc Chloride in plastic continer | Zinc Chloride | Hospira | RK Pharma | 217625 |
| 04/14/2025 | Canasa | Mesalamine | AbbVie | Rising | 219028 |
| 04/14/2025 | Riomet | Metformin HCl | Ranbaxy | Bionpharma | 219151 |
| 04/14/2025 | Xalatan | Latanoprost | Upjohn | Micro Labs | 219306 |
| 04/15/2025 | Mezofy | Aripiprazole | CMG Pharm | CMG Pharm | N211448 |
| 04/15/2025 | Ranexa | Ranolazine | Menarini | Jubilant Generics | 211361 |
| 04/15/2025 | Stalevo 50 | Carbidopa / Entacapone / Levodopa | Orion Pharma | Macleods | 214495 |
| 04/15/2025 | Banzel | Rufinamide | Esai | MSN | 214817 |
| 04/15/2025 | Nitroglycerin | Nitroglycerin | Fougera Pharms | Encube | 218235 |
| 04/15/2025 | Alinia | Nitazoxanide | Romark | Annora Pharma | 218701 |
| 04/15/2025 | Nexium | Esomeprazole Magnesium | AstraZeneca | Aurobindo | 218948 |
| 04/15/2025 | Nexium | Esomeprazole Magnesium | AstraZeneca | Aurobindo | 219213 |
| 04/15/2025 | Intuniv | Guanfacine HCl | Takeda Pharms | Rubicon | 219689 |
| 04/16/2025 | Epzicom | Abacavir Sulfate / Lamivudine | ViiV Healthcare | Hetero | 205412 |
| 04/16/2025 | Rowasa | Mesalamine | Mylan | Novitium Pharma | 215269 |
| 04/16/2025 | Tegretol | Carbamazepine | Novartis | Alembic | 216623 |
| 04/16/2025 | Frova | Frovatriptan Succinate | Endo | Leading | 216998 |
| 04/16/2025 | Valcyte | Valganciclovir HCl | Cheplapharm | Sph Zhongxi Pharm | 218027 |
| 04/16/2025 | Zebeta | Bisoprolol Fumarate | Teva | Unique Pharm | 219044 |
| 04/16/2025 | Depo-Medrol | Methylprednisolone Acetate | Pfizer | Hikma | 219145 |
| 04/17/2025 | Allegra-D | Fexofenadine HCl / Pseudoephedrine HCl | Chattem Sanofi | Aurobindo | 215232 |
| 04/17/2025 | Vitamin K1 | Phytonadione | Hospira | Caplin | 219212 |
| 04/18/2025 | Welchol | Colesevelam HCl | Cosette | Macleods | 204893 |
| 04/21/2025 | Gleevec | Imatinib Mesylate | Novartis | CSPC Ouyi | 212193 |
| 04/22/2025 | Qamzova | Meloxicam | Nanjing Delova | Nanjing Delova | N217593 |
| 04/22/2025 | Sprycel | Dasatinib | Bristol Myers Squibb | Eugia Pharma | 216547 |
| 04/22/2025 | Mayzent | Siponimod | Novartis | Riconpharma | 218444 |
| 04/23/2025 | Jynarque | Tolvaptan | Otsuka | Lupin | 216063 |
| 04/23/2025 | Noxafil | Posaconazole | Merck | Qilu Pharm Hainan | 217720 |
| 04/23/2025 | Ganirelix Acetate | Ganirelix Acetate | Oraganon | Qilu | 218855 |
| 04/24/2025 | Kloxxado | Naloxone HCl | Hikma | Padagis | 216719 |
| 04/25/2025 | Chlorpromazine HCl | Chlorpromazine HCl | Upsher Smith Labs | Aurobindo | 216788 |
| 04/25/2025 | Brovana | Arformoterol Tartrate | Lupin | Saba Ilac Sanayi | 218429 |
| 04/28/2025 | Niaspan | Niacin | AbbVie | Zydus | 203285 |
| 04/28/2025 | Corlanor | Ivabradine HCl | Amgen | MSN | 213483 |
| 04/28/2025 | Vuity | Pilocarpine HCl | AbbVie | Amneal | 217733 |
| 04/28/2025 | Hydroxyzine HCl | Hydroxyzine HCl | Chartwell | Bionpharma | 219289 |
| 04/29/2025 | Celebrex | Celecoxib | Upjohn | Strides | 213127 |
| 04/29/2025 | Vyzulta | Latanoprostene Bunod | Bausch and Lomb | Gland | 217387 |
| 04/29/2025 | Kuvan | Sapropterin Dihydrochloride | BioMarin Pharm | Shanghai Aucyun | 218645 |
| 04/30/2025 | Atzumi | Dihydroergotamine Mesylate | Satsuma Pharms | Satsuma Pharms | N217901 |
| 04/30/2025 | Oxtellar XR | Oxcarbazepine | Supernus | Aurobindo | 219241 |
| 05/01/2025 | Brilinta | Ticagrelor | AstraZeneca | Apotex | 208584 |
| 05/01/2025 | Midazolam in 0.8% Sodium Chloride | Midazolam | Exela | Sterinova | 218454 |
| 05/01/2025 | Zinc Sulfate | Zinc Sulfate | American Regent | Aspiro | 219585 |
| 05/01/2025 | Flomax | Tamsulosin HCl | Sanofi Aventis | Graviti Pharms | 219767 |
| 05/02/2025 | Wellbutrin SR | Bupropion HCl | GlaxoSmithKline | Ipca Labs | 207874 |
| 05/02/2025 | Brilinta | Ticagrelor | AstraZeneca | Alembic | 208576 |
| 05/02/2025 | Zovirax | Acyclovir | Bausch | Cipla | 212981 |
| 05/02/2025 | Chantix | Varenicline Tartrate | PF Prism | Aurobindo | 214595 |
| 05/02/2025 | Duobrii | Halobetasol Propionate / Tazarotene | Bausch | Taro | 217190 |
| 05/02/2025 | Xarelto | Rivaroxaban | Janssen | Apotex | 217810 |
| 05/02/2025 | Cortef | Hydrocortisone | Pharmacia / Upjohn | Novitium Pharma | 217881 |
| 05/02/2025 | Ortho-Cept | Desogestrel / Ethinyl Estradiol | Janssen | Avion Pharms | 218933 |
| 05/05/2025 | Brilinta | Ticagrelor | AstraZeneca | Invagen | 208537 |
| 05/05/2025 | Azilect | Rasagiline Mesylate | Teva | Torrent | 210150 |
| 05/05/2025 | Methadone HCl | Methadone HCl | Mylan | Hikma | 218609 |
| 05/06/2025 | Chantix | Varenicline Tartrate | PF Prism | Viwit Pharm | 212879 |
| 05/06/2025 | Myrbetrio | Mirabegron | Apgdi | Sawai | 217061 |
| 05/06/2025 | Isentress HD | Raltegravir Potassium | Merck Sharp Dhome | Lupin | 217990 |
| 05/07/2025 | Copaxone | Glatiramer Acetate | Teva | Chemi | 208468 |
| 05/12/2025 | Hytrin | Terazosin HCl | Abbott Labs | Ajanta | 219482 |
| 05/12/2025 | Zonegran | Zonisamide | Advanz Pharma | Macleods | 219507 |
| 05/13/2025 | Docetaxel | Docetaxel | Shilpa | Guangdong Sunho | 213768 |
| 05/13/2025 | Selzentry | Maraviroc | ViiV Healthcare | Navinta | 217880 |
| 05/13/2025 | Bactroban | Mupirocin | GlaxoSmithKline | Encube | 217943 |
| 05/13/2025 | Haldol | Haloperidol Decanoate | Janssen | Caplin | 219168 |
| 05/14/2025 | Pradaxa | Dabigatran Etexilate Mesylate | Boehringer Ingelheim | Aurobindo | 208039 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Dr. Reddy's Labs | 208534 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Invagen Pharms | 208543 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Lupin | 208555 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Alembic | 210301 |
| 05/14/2025 | Tribenzor | Amlodipine Besylate/ Hydrochlorothiazide/ Olmesartan Medoxomil | Cosette | Piramal | 210718 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Macleods | 213114 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Sunshine | 213348 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Changzhou Pharm | 216995 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Biocon Pharma | 218107 |
| 05/14/2025 | Xarelto | Rivaroxaban | Janssen | Ascent Pharms | 219332 |
| 05/15/2025 | Xarelto | Rivaroxaban | Janssen | Breckenridge | 208220 |
| 05/15/2025 | Xarelto | Rivaroxaban | Janssen | Aurobindo | 208544 |
| 05/15/2025 | Nasonex | Mometasone Furoate | Organon | Naspress | 211706 |
| 05/15/2025 | Abraxane | Paclitaxel | Bristol Myers Squibb | Shuangcheng | 216355 |
| 05/16/2025 | Crestor | Rosuvastatin Calcium | AstraZeneca | Mankind | 206603 |
| 05/16/2025 | Iressa | Gefitinib | AstraZeneca | Cipla | 211826 |
| 05/16/2025 | Protonix IV | Pantoprazole Sodium | Wyeth | Deva Holding | 215074 |
| 05/16/2025 | Zyprexa | Olanzapine | Cheplapharm | Qilu | 218116 |
| 05/19/2025 | Amicar | Aminocaproic Acid | Hikma | Apozeal Pharms | 213216 |
| 05/19/2025 | Diazepam | Diazepam | Hospira | Galenicum Health | 216422 |
| 05/19/2025 | Compazine | Prochlorperazine Maleate | GlaxoSmithKline | Cerovene | 217847 |
| 05/20/2025 | Complera | Emtricitabine / Rilpivirine HCl / Tenofovir Disoproxil Fumarate | Gilead Sciences | Mylan | 208452 |
| 05/20/2025 | Lyrica | Pregabalin | Upjohn | Jubilant | 209530 |
| 05/20/2025 | Vidaza | Azacitidine | Bristol Myers Squibb | Reliance Life | 217453 |
| 05/20/2025 | Lotemax | Loteprednol Etabonate | Bausch and Lomb | Amneal | 217484 |
| 05/21/2025 | Chantix | Varenicline Tartrate | PF Prism | Handa | 213268 |
| 05/22/2025 | Absorica | Isotretinoin | Sun | Zydus | 216633 |
| 05/22/2025 | Caduet | Amlodipine Besylate / Atorvastatin Calcium | Pharmacia | Alembic | 217279 |
| 05/22/2025 | Revlimid | Lenalidomide | Bristol Myers Squibb | Deva Holding | 217554 |
| 05/22/2025 | Yutrepia | Treprostinil Sodium | Liquidia Tech | Liquidia Tech | N213005 |
| 05/23/2025 | Bosulif | Bosutinib Monohydrate | PF Prism | Alembic | 209543 |
| 05/23/2025 | Fycompa | Perampanel | Catalyst | Teva | 209801 |
| 05/23/2025 | Vimpat | Lacosamide | UCB | Westminster Pharms | 218706 |
| 05/27/2025 | Topamax | Topiramate | Janssen | Rubicon | 216683 |
| 05/28/2025 | Relistor | Methylnaltrexone Bromide | Salix | Mylan | 208592 |
| 05/28/2025 | Magnesium Sulfate | Magnesium Sulfate | Fresenius Kabi | Aspiro | 219777 |
| 05/29/2025 | Zemuron | Rocuronium Bromide | Organon | Mankind | 219674 |
| 05/30/2025 | Diamox | Acetazolamide | Teva | Aurobindo | 212089 |
| 06/02/2025 | Ambisome | Amphotericin B | Astellas | Avet Lifesciences | 215354 |
| 06/02/2025 | Apresoline | Hydralazine HCl | Novartis | Kindos | 217501 |
| 06/02/2025 | Pepcid | Famotidine | Salix | Lannett | 217982 |
| 06/02/2025 | Velcade | Bortezomib | Takeda | Medicamen Biotech | 218688 |
| 06/02/2025 | Tranexamic Acid | Tranexamic Acid | Exela | RTU Pharma | 218896 |
| 06/03/2025 | Giapreza | Angiotensin II Acetate | La Jolla Pharma | Gland | 216966 |
| 06/03/2025 | Monurol | Fosfomycin Tromethamine | Zambon | Precision Dose | 217187 |
| 06/03/2025 | Cetrotide | Cetrorelix Acetate | EMD Serano | Xiromed | 218061 |
| 06/03/2025 | Epinephrine | Epinephrine | BPI Labs | Gland | 218144 |
| 06/04/2025 | Janumet XR | Metformin HCl / Sitagliptin Phosphate | Merck | Endo | 204144 |
| 06/05/2025 | Xifyrm | Meloxicam | Azurity | Azurity | N218395 |
| 06/05/2025 | Prexxartan | Valsartan | Carmel Biosciences | Rubicon | 216460 |
| 06/05/2025 | Flonase | Fluticasone Propionate | Haleon | Rubicon | 218321 |
| 06/06/2025 | Bentyl | Dicyclomine HCl | Allergan | Prinston | 218310 |
| 06/09/2025 | Zemuron | Rocuronium Bromide | Organon | Fresenius Kabi | N217472 |
| 06/09/2025 | Halaven | Eribulin Mesylate | Esai | Sandoz | 214310 |
| 06/09/2025 | Kuvan | Sapropterin Dihydrochloride | Biomarin Pharm | Aurobindo | 216797 |
| 06/09/2025 | Lupron | Leuprolide Acetate | AbbVie | Endo | 217437 |
| 06/09/2025 | Transderm Scop | Scopolamine | Baxter Healthcare | Amneal | 218384 |
| 06/10/2025 | SPS | Sodium Polystyrene Sulfonate | CMP Pharma | Lyne | 214912 |
| 06/10/2025 | Zinc Sulfate | Zinc Sulfate | American Regent | Stira | 217624 |
| 06/11/2025 | Zyprexa | Olanzapine | Cheplapharm | UBI | 211072 |
| 06/11/2025 | Pred Forte | Prednisolone Acetate | AbbVie | Amneal | 218256 |
| 06/11/2025 | Lysteda | Tranexamic Acid | Amring Pharms | Appco | 218729 |
| 06/11/2025 | Kuvan | Sapropterin Dihydrochloride | Biomarin Pharm | Zenara | 218797 |
| 06/11/2025 | Selenious Acid | Selenious Acid | American Regent | Aspiro | 219633 |
| 06/12/2005 | Zusduri | Mitomycin | Urogen | Urogen | N215793 |
| 06/12/2025 | Qsymia | Phentermine HCl / Topiramate | Vivus | Dr. Reddy's Labs | 208175 |
| 06/12/2025 | Hicon | Sodium Iodide I-131 | Jubilant | Cardinal Health | 213615 |
| 06/13/2025 | Xadago | Safinamide Mesylate | MDD US | Zenara | 215913 |
| 06/13/2025 | Cleocin T | Clindamycin Phosphate | Pfizer | Carnegie | 219612 |
| 06/16/2025 | Mozobil | Plerixafor | Genzyme | Hetero | 217560 |
| 06/17/2025 | Diamox | Acetazolamide Sodium | Teva | Gland | 219775 |
| 06/20/2025 | Otezla | Apremilast | Amgen | Torrent | 211834 |
| 06/23/2025 | Amitriptyline HCl | Amitriptyline HCl | Sandoz | Unique Pharm | 218389 |
| 06/23/2025 | Meropenem | Meropenem | HQ Specialty Pharma | Brooks Steriscience | 219084 |
| 06/23/2025 | Pepcid | Famotidine | Salix | Bionpharma | 219153 |
| 06/23/2025 | Bentyl | Dicyclomine HCl | Allergan | Rising | 219242 |
| 06/23/2025 | Ablysinol | Alcohol | BPI Labs | Accord | 217845 |
| 06/23/2025 | Ablysinol | Alcohol | BPI Labs | Xgen Pharms | 219400 |
| 06/23/2025 | Ablysinol | Alcohol | BPI Labs | Breckenridge | 219444 |
| 06/23/2025 | Orapred | Prednisolone | Concordia | Tulex Pharms | 219509 |
| 06/24/2025 | Diphenhydramine HCl | Diphenhydramine HCl | West-Ward Pharms | Avet Lifesciences | 205336 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Hikma | 217662 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | MSN | 218177 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Alkem | 218295 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Torrent | 218778 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Zenara | 218795 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | SKG Pharma | 218812 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Lupin | 218847 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Appco | 218963 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Apotex | 218977 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Somerset Therapeutics | 219078 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Annora Pharma | 219160 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | Aggrega | 219193 |
| 06/24/2025 | Motegrity | Prucalopride Succinate | Takeda | H2-Pharma | 219216 |
| 06/25/2025 | Toprol-XL | Metoprolol Succinate | Toprol | Ipca Labs | 206980 |
| 06/25/2025 | Cardene | Nicardipine HCl | Chiesi | Navinta | 218638 |
| 06/26/2025 | Xarelto | Rivaroxaban | Janssen | Alkem | 218502 |
| 06/26/2025 | Vimpat | Lacosamide | UCB | Ajenat Pharms | 219699 |
| 06/26/2025 | Sodium Bicarbonate in plastic container | Sodium Bicarbonate | Abbott Labs | Anthea Pharma | 219701 |
| 06/27/2025 | Avgemsi | Gemcitabine | Avyxa | Avyxa | N219920 |
| 06/27/2025 | Doxil (Liposomal) | Doxorubicin HCl | Baxter Healthcare | Alembic | 219199 |
| 06/27/2025 | Ganirelix Acetate | Ganirelix Acetate | Organon | Tris Pharma | 219454 |
| 06/30/2025 | Ambisome | Amphotericin B | Astellas | Mylan | 212967 |
| 06/30/2025 | Carnitor | Levocarnitine | Leadiant Biosciences | Deva Holding | 217430 |
| 06/30/2025 | Myrbetriq | Mirabegron | Apgdi | Qilu | 217989 |
| 06/30/2025 | Rogaine Extra Strength | Minoxidil | Kenvu Brands | Taro | 217998 |
| 06/30/2025 | Lotemax SM | Loteprednol Etabonate | Bausch and Lomb | Lupin | 218087 |
| 06/30/2025 | Emflaza | Deflazacort | PTC Therapeutics | Aucta | 219417 |
| 06/30/2025 | Duexis | Famotidine / Ibuprofen | Horizon Medicines | Aurobindo | 219538 |
