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 # |
| 10/01/2025 | Wellbutrin XL | Bupropion HCl | Bausch | Annora | 217898 |
| 10/01/2025 | Rayos | Prednisone | Horizon | Dr. Reddy's Labs | 219477 |
| 10/01/2025 | Oracea | Doxycycline | Galderma | Changzhou | 219978 |
| 10/02/2025 | Vancomycin HCl | Vancomycin HCl | Mylan | Steriscience | 215324 |
| 10/02/2025 | Isopto Carpine | Pilocarpine HCl | Sandoz | FDC | 217052 |
| 10/02/2025 | Trandate | Labetalol HCl | Sebela | Amneal | 218870 |
| 10/02/2025 | Intelence | Etravirine | Johnson & Johnson | Bionpharma | 219152 |
| 10/02/2025 | Remeron | Mirtazapine | Organon | Annora | 219721 |
| 10/03/2025 | Abreva | Docosanol | Haleon | Dr. Reddy's Labs | 214613 |
| 10/03/2025 | Naprosyn | Naproxen | Atnahs | Aurobindo | 216504 |
| 10/03/2025 | Clomid | Clomiphene Citrate | Sanofi Aventis | Accord | 219406 |
| 10/03/2025 | Emflaza | Deflazacort | PTC Therapeutics | Zydus | 220042 |
| 10/06/2025 | Tribenzor | Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil | Cosette | Hetero | 209242 |
| 10/06/2025 | Lidoderm | Lidocaine | Teikoku | Alkem | 216484 |
| 10/07/2025 | Lasix Onyu | Furosemide | SQ Innovation | SQ Innovation | N217294 |
| 10/07/2025 | Xarelto | Rivaroxaban | Janssen | Taro | 208557 |
| 10/07/2025 | Absorica | Isotretinoin | Sun | Amneal | 216097 |
| 10/07/2025 | Allegra-D | Fexofenadine HCl / Pseudoephedrine HCl | Chattem Sanofi | Perrigo | 216792 |
| 10/07/2025 | Lamictal ODT | Lamotrigine | GlaxoSmithKline | Taro | 219677 |
| 10/10/2025 | Thorazine | Chlorpromazine HCl | GlaxoSmithKline | Rubicon | 216678 |
| 10/10/2025 | Gallium Ga-68 Edotreotide | Gallium Ga-68 Edotreotide | University of Iowa | Methodist | 218845 |
| 10/14/2025 | Adrenalin | Epinephrine | PH Health | Amneal | 217485 |
| 10/15/2025 | Premarin | Estrogens, Conjugated | Wyeth | Novast | 214023 |
| 10/15/2025 | Premarin | Estrogens, Conjugated | Wyeth | Novast | 214025 |
| 10/16/2025 | Tigan | Trimethobenzamide HCl | PH Health | BPI | 219606 |
| 10/17/2025 | Kenalog-40 | Triamcinolone Acetonide | Apothecon | Alembic | 218601 |
| 10/17/2025 | Clomid | Clomiphene Citrate | Sanofi Aventis | Novitium | 219781 |
| 10/22/2025 | Contempo | Fosfomycin Disodium | Meitheal | Meitheal | N212271 |
| 10/22/2025 | Abilify | Aripiprazole | Otsuka | Quagen | 215582 |
| 10/22/2025 | Lucemyra | Lofexidine HCl | BiCorRx | Novitium | 219917 |
| 10/22/2025 | Cardene | Nicardipine HCl | Chiesi | Caplin | 220243 |
| 10/23/2025 | Javadin | Clonidine HCl | Azurity | Azurity | N220256 |
| 10/23/2025 | Abreva | Docosanol | Haleon | Dr. Reddy's Labs | 215505 |
| 10/23/2025 | Dalvance | Dalbavancin HCl | AbbVie | Teva | 219465 |
| 10/24/2025 | Xarelto | Rivaroxaban | Janssen | MSN Labs | 208546 |
| 10/24/2025 | Atropine Sulfate | Atropine Sulfate | Accord | Hikma | 217345 |
| 10/27/2025 | Gleostine | Lomustine | Azurity | Carnegie | 219265 |
| 10/27/2025 | Cuvposa | Glycopyrrolate | Merz | Ajenat | 219267 |
| 10/27/2025 | Renvela | Sevelamer Carbonate | Sanofi | Navinta | 219931 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Sunshine | 208508 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Invagen | 208537 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Dr. Reddy's Labs | 208541 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Alembic | 208576 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Apotex | 208584 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | MSN Labs | 208596 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Alkem | 210219 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Taro | 211498 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Macleods | 212258 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | Changzhou | 216187 |
| 10/28/2025 | Angeliq | Drospirenone / Estradiol | Bayer | Novast | 218031 |
| 10/28/2025 | Brilinta | Ticagrelor | AstraZeneca | ScieGen | 218962 |
| 10/28/2025 | Nicardipine HCl | Nicardipine HCl | Hikma | Qilu | 219608 |
| 10/29/2025 | Cortisporin | Hydrocortisone / Neomycin Sulfate / Polymyxin B Sulfate | Monarch | Amneal | 217803 |
| 10/29/2025 | Chantix | Varenicline Tartrate | Pfizer | Micro Labs | 218302 |
| 10/30/2025 | Inlyta | Axitinib | Pfizer | Apotex | 211650 |
| 10/30/2025 | Afinitor | Everolimus | Novartis | Novugen | 219955 |
| 11/03/2025 | Tradjenta | Linagliptin | Boehringer Ingelheim | Aurobindo | 208415 |
| 11/03/2025 | Jentadueto | Linagliptin / Metformin HCl | Boehringer Ingelheim | Dr. Reddy's Labs | 208427 |
| 11/03/2025 | Tradjenta | Linagliptin | Boehringer Ingelheim | Dr. Reddy's Labs | 208428 |
| 11/03/2025 | Tradjenta | Linagliptin | Boehringer Ingelheim | Mylan | 208431 |
| 11/03/2025 | Tradjenta | Linagliptin | Boehringer Ingelheim | MSN Labs | 208457 |
| 11/03/2025 | Jentaduento | Linagliptin / Metformin HCl | Boehringer Ingelheim | MSN Labs | 208459 |
| 11/03/2025 | Aptiom | Eslicarbazepine Acetate | Sumitomo | SPH Zhongxi | 211247 |
| 11/04/2025 | Selzentry | Maraviroc | ViiV | Rhodes | 216143 |
| 11/04/2025 | Forane | Isoflurane | Baxter | Shandong | 216527 |
| 11/04/2025 | Phytonadione | Phytonadione | Int'l Medication | Amneal | 216601 |
| 11/04/2025 | Myrbetriq | Mirabegron | Apgdi | MSN Labs | 218543 |
| 11/04/2025 | Azulfidine | Sulfasalazine | Pfizer | Rising | 219046 |
| 11/04/2025 | Avapro | Irbesartan | Sanofi Aventis | MSN Labs | 219539 |
| 11/05/2025 | Xyrem | Sodium Oxybate | Jazz | Ascent | 210523 |
| 11/05/2025 | Opsumit | Macitentan | Actelion | Laurus | 211120 |
| 11/05/2025 | Voltaren | Diclofenac Sodium | Novartis | Umedica | 219945 |
| 11/06/2025 | Imitrex Statdose | Sumatriptan Succinate | GlaxoSmithKline | Alembic | 213518 |
| 11/06/2025 | Sprycel | Dasatinib | Bristol-Myers Squibb | Alembic | 216261 |
| 11/06/2025 | Vibramycin | Doxycycline Hyclate | Pfizer | Steriscience | 217972 |
| 11/10/2025 | Dalvance | Dalbavancin HCl | AbbVie | Fresenius Kabi | 217591 |
| 11/10/2025 | Requip XL | Ropinirole HCl | GlaxoSmithKline | Elite | 217862 |
| 11/10/2025 | Cipro HC | Ciprofloxacin HCl / Hydrocortisone | Sandoz | Cosette | 218273 |
| 11/10/2025 | Jynarque | Tolvaptan | Otsuka | Apotex | 218381 |
| 11/12/2025 | Leucovorin Calcium | Leucovorin Calcium | Hospira | Gland | 218200 |
| 11/12/2025 | Vumerity | Diroximel Fumarate | Biogen | Zydus | 218596 |
| 11/12/2025 | Dexilant | Dexlansoprazole | Takeda | Alembic | 219115 |
| 11/13/2025 | Briviact | Brivaracetam | UCB | MSN | 214921 |
| 11/13/2025 | Lupron | Leuprolide Acetate | AbbVie | Zydus | 215826 |
| 11/13/2025 | Omnipaque 300 | Iohexol | GE Healthcare | Amneal | 217737 |
| 11/13/2025 | Isoptin | Verapamil HCl | MT Adams | Aspiro | 218218 |
| 11/13/2025 | Lipitor | Atorvastatin Calcium | Upjohn | Teva | 220276 |
| 11/14/2025 | Diphenhydramine HCl | Diphenhydramine HCl | West-Ward | Avet | 205337 |
| 11/14/2025 | Xarelto | Rivaroxaban | Janssen | Apotex | 208579 |
| 11/14/2025 | Diastat Acudial | Diazepam | Bausch | Navinta | 217468 |
| 11/14/2025 | Monurol | Fosfomycin Tromethamine | Zambon | Aurobindo | 217608 |
| 11/14/2025 | Cardizem | Diltiazem HCl | Bausch | Alembic | 217633 |
| 11/14/2025 | Revlimid | Lenalidomide | Bristol-Myers Squibb | Accord | 218872 |
| 11/14/2025 | Vfend | Voriconazole | Pfizer | Hainan Poly | 220043 |
| 11/17/2025 | Xeljanz XR | Tofacitinib Citrate | Pfizer | Biocon | 219442 |
| 11/17/2025 | Immodium A-D | Loperamide HCl | Kenvue | Marksans | 220153 |
| 11/18/2025 | Prolixin | Fluphenazine HCl | Apothecon | Hetero | 218769 |
| 11/18/2025 | Keveyis | Dichlorphenamide | Xeris | Rising | 218783 |
| 11/19/2025 | Tasigna | Nilotinib HCl | Novartis | Hetero | 209651 |
| 11/19/2025 | Vibra-Tabs | Doxycycline Hyclate | Pfizer | Macleods | 211418 |
| 11/19/2025 | Tasigna | Nilotinib HCl | Novartis | Dr. Reddy's Labs | 218350 |
| 11/19/2025 | Tasigna | Nilotinib HCl | Novartis | MSN | 218544 |
| 11/20/2025 | Olux | Clobetasol Propionate | Pharmobedient | Xiromed | 210638 |
| 11/20/2025 | Potassium Chloride | Potassium Chloride | Genus | Aurobindo | 216536 |
| 11/21/2025 | Keppra | Levetiracetam | UCB | Guardian | 218080 |
| 11/24/2025 | Tribenzor | Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil | Cosette | Micro Labs | 207437 |
| 11/24/2025 | Tazorac | Tazarotene | Almirall | Long Grove | 214560 |
| 11/24/2025 | Mavenclad | Cladribine | EMD Serono | Apotex | 218425 |
| 11/24/2025 | Calan SR | Verapamil HCl | Pfizer | Zydus | 219252 |
| 11/25/2025 | Fycompa | Perampanel | Catalyst | Taro | 209538 |
| 11/25/2025 | Fycompa | Perampanel | Catalyst | MSN Labs | 218178 |
| 11/25/2025 | Levophed | Norepinephrine Bitartrate | Hospira | Anthea | 219924 |
| 11/26/2025 | Dalvance | Dalbavancin HCl | AbbVie | Kindos | 218929 |
| 11/28/2025 | Restasis | Cyclosporine | AbbVie | Amneal | 211909 |
| 12/01/2025 | Proair HFA | Albuterol Sulfate | Teva | Amneal | 211600 |
| 12/02/2025 | Janumet | Metformin HCl / Sitagliptin Phosphate | Merck | Sandoz | 202388 |
| 12/02/2025 | Keppra | Levetiracetam | UCB | Knack | 215465 |
| 12/02/2025 | Diprivan | Propofol | Fresenius Kabi | Nanjing King-Friend | 217945 |
| 12/03/2025 | Opsumit | Macitentan | Actelion | Seasons Biotechnology | 211026 |
| 12/03/2025 | Opsumit | Macitentan | Actelion | Mylan | 211161 |
| 12/05/2025 | Ofirmev | Acetaminophen | Mallinckrodt | Caplin | 219096 |
| 12/08/2025 | Imvexxy | Estradiol | Mayne | Teva | 214137 |
| 12/08/2025 | Adrenalin | Epinephrine | PH Health | Amneal | 218208 |
| 12/08/2025 | Zyvox | Linezolid | Pfizer | Caplin | 219558 |
| 12/09/2025 | Vibramycin | Doxycycline Hyclate | Pfizer | Macleods | 211137 |
| 12/10/2025 | Isuprel | Isoproterenol HCl | Bausch | Deva Holding | 213305 |
| 12/10/2025 | Zylet | Loteprednol Etabonate / Tobramycin | Bausch & Lomb | Alembic | 217597 |
| 12/10/2025 | Subutex | Buprenorphine HCl | Indivior | SpecGX | 218473 |
| 12/10/2025 | Zegerid | Omeprazole / Sodium Bicarbonate | Salix | Novitium | 219161 |
| 12/11/2025 | Kaletra | Lopinavir / Ritonavir | AbbVie | Micro Labs | 214696 |
| 12/11/2025 | Levophed | Norepinephrine Bitartrate | Hospira | MSN Labs | 218595 |
| 12/11/2025 | Advil Dual Action with Acetaminophen | Acetaminophen / Ibuprofen | Haleon | LNK | 220126 |
| 12/11/2025 | Ferriprox | Deferiprone | Chiesi | Senores | 220132 |
| 12/12/2025 | Forteo | Teriparatide | Eli Lilly | Amphastar | 213641 |
| 12/12/2025 | Sandostatin Lar | Octreotide Acetate | Novartis | Mylan | 216589 |
| 12/12/2025 | Emflaza | Deflazacort | PTC Therapeutics | Amneal | 217173 |
| 12/15/2025 | Tasigna | Nilotinib HCl | Novartis | Torrent | 218532 |
| 12/15/2025 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Ascent | 219727 |
| 12/16/2025 | Vybrique | Sildenafil Citrate | IBSA | IBSA | N210858 |
| 12/16/2025 | QVAR | Beclomethasone Dipropionate | Teva | Amneal | 213811 |
| 12/16/2025 | Vraylar | Cariprazine HCl | AbbVie | Aurobindo | 213982 |
| 12/16/2025 | Hydroxyzine HCl | Hydroxyzine HCl | Chartwell | Novitium | 219648 |
| 12/17/2025 | Travatan Z | Travoprost | Sandoz | Alembic | 214687 |
| 12/17/2025 | Velcade | Bortezomib | Takeda | Shuangcheng | 216528 |
| 12/17/2025 | Xalatan | Latanoprost | Upjohn | Mankind | 220360 |
| 12/18/2025 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Micro Labs | 206157 |
| 12/18/2025 | Haldol | Haloperidol | Ortho-McNeil | Creekwood | 218162 |
| 12/18/2025 | Rectiv | Nitroglycerin | AbbVie | Solaris | 218756 |
| 12/18/2025 | Subutex | Buprenorphine HCl | Indivior | Ascent | 219401 |
| 12/19/2025 | Dacogen | Decitabine | Otsuka | Reliance Life Sciences | 217814 |
| 12/22/2025 | Wegovy | Semaglutide | Novo Nordisk | Novo Nordisk | N218316 |
| 12/22/2025 | Potassium Chloride | Potassium Chloride | Genus | Quagen | 215716 |
| 12/23/2025 | Akovaz | Ephedrine Sulfate | Exela | Civica | 215593 |
| 12/23/2025 | ProvayBlue | Methylene Blue | Provepharm | Chengdu Shuode | 219550 |
| 12/23/2025 | Cuvposa | Glycopyrrolate | Merz | Bionpharma | 220062 |
| 12/29/2025 | Javuvia | Sitagliptin Phosphate | Merck | Watson | 202327 |
| 12/29/2025 | Sudafed | Pseudoephedrine HCl | Kenvue | Aurobindo | 218854 |
| 12/29/2025 | Veletri | Epoprostenol Sodium | Actelion | Gland | 219237 |
| 12/29/2025 | Loperamide HCl | Loperamide HCl | Bionpharma | Aurobindo | 220372 |
| 12/30/2025 | Calcium Gluconate | Calcium Gluconate | Fresenius Kabi | Sagent | 219619 |
| 12/31/2025 | Copaxone | Glatiramer Acetate | Teva | ScinoPharm Taiwan | 214741 |
| 12/31/2025 | Selenious Acid | Selenious Acid | American Regent | RK Pharma | 218536 |
