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 # |
| 01/02/2026 | Advil Dual Action with Acetaminophen | Acetaminophen / Ibuprofen | Haleon | Taro | 219053 |
| 01/02/2026 | Dilantin | Phenytoin Sodium | Viatris | Mankind | 219773 |
| 01/05/2026 | Carafate | Sucralfate | AbbVie | Glenmark | 212141 |
| 01/06/2026 | Zemuron | Rocuronium Bromide | Organon | Knack | 213476 |
| 01/06/2026 | Pataday | Olopatadine HCl | Alcon | Gland | 213514 |
| 01/06/2026 | Ciprodex | Ciprofloxacin; Dexamethasone | Sandoz | Upsher Smith | 216487 |
| 01/06/2026 | Bortezomib | Bortezomib | Hospira | Gland | 219167 |
| 01/07/2026 | Lovenox | Enoxaparin Sodium | Sanofi Aventis | Hebei Changshan | 218775 |
| 01/08/2026 | Lamictal ODT | Lamotrigine | GlaxoSmithKline | Torrent | 217100 |
| 01/08/2026 | Furosemide | Furosemide | American Regent | Micro Labs | 218188 |
| 01/08/2026 | Diflucan | Fluconazole | Pfizer | Fdc | 218692 |
| 01/08/2026 | Kuvan | Sapropterin Dihydrochloride | Biomarin | Micro Labs | 219511 |
| 01/09/2026 | Vitamin K1 | Phytonadione | Hospira | Sunny | 215090 |
| 01/09/2026 | Afinitor Disperz | Everolimus | Novartis | Biocon | 217216 |
| 01/09/2026 | Chantix | Varenicline Tartrate | PF Prism | Umedica | 218985 |
| 01/12/2026 | Advair Diskus | Fluticasone Propionate / Salmeterol Xinafoate | Glaxo | Respirent | 214464 |
| 01/12/2026 | Trokendi XR | Topiramate | Supernus | Ascent | 217443 |
| 01/13/2026 | Sodium Bicarbonate | Sodium Bicarbonate | Abbott | Amneal | 217523 |
| 01/14/2026 | Januvia | Sitagliptin Phosphate | Merck | Sandoz | 202387 |
| 01/14/2026 | Promacta | Eltrombopag Olamine | Novartis | Amneal | 212884 |
| 01/14/2026 | Promacta | Eltrombopag Olamine | Novartis | Zydus | 216281 |
| 01/14/2026 | Victoza | Liraglutide | Novo Nordisk | Orbicular | 217590 |
| 01/14/2026 | Promacta | Eltrombopag Olamine | Novartis | Somerset | 219638 |
| 01/14/2026 | Promacta | Eltrombopag Olamine | Novartis | MSN | 220250 |
| 01/15/2026 | Oxaliplatin | Oxaliplatin | Teva | Shandong | 219765 |
| 01/16/2026 | Motegrity | Prucalopride Succinate | Takeda | Ajanta | 219220 |
| 01/20/2026 | Januvia | Sitagliptin Phosphate | Merck | Apotex | 202425 |
| 01/20/2026 | Sertraline Hydrochloride | Sertraline Hydrochloride | Almatica | Umedica | 218342 |
| 01/20/2026 | Sertraline Hydrochloride | Sertraline Hydrochloride | Almatica | Appco | 218712 |
| 01/20/2026 | Myrbetriq | Mirabegron | Astellas | Alkem | 219323 |
| 01/20/2026 | Sertraline Hydrochloride | Sertraline Hydrochloride | Almatica | Novitium | 219714 |
| 01/20/2026 | Entresto | Sacubitril / Valsartan | Novartis | Somerset | 219983 |
| 01/21/2026 | Restasis | Cyclosporine | AbbVie | TWi | 209064 |
| 01/21/2026 | Tricor | Fenofibrate | AbbVie | Macleods | 210379 |
| 01/21/2026 | Ziac | Bisoprolol Fumarate / Hydrochlorothiazide | Teva | Aurobindo | 217922 |
| 01/21/2026 | Mycamine | Micafungin Sodium | Astellas | Hisun | 219712 |
| 01/21/2026 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Ascent | 219850 |
| 01/21/2026 | Vimpat | Lacosamide | UCB | Anthea | 220268 |
| 01/22/2026 | Tamiflu | Oseltamivir Phosphate | Roche | Upsher Smith | 213437 |
| 01/22/2026 | Norvasc | Amlodipine Besylate | Viatris | Teva | 219686 |
| 01/23/2026 | Zyprexa | Olanzapine | Cheplapharm | Omnivium | 219048 |
| 01/26/2026 | Invega | Paliperidone | Janssen | Apotex | 203279 |
| 01/26/2026 | Durezol | Difluprednate | Sandoz | Alembic | 213774 |
| 01/26/2026 | Chlorpromazine HCl | Chlorpromazine HCl | Hikma | MSN | 216092 |
| 01/26/2026 | Cupric Chloride | Cupric Chloride | Hospira | Amneal | 217287 |
| 01/26/2026 | Nucynta | Tapentadol HCl | Collegium | Novitium | 219119 |
| 01/26/2026 | Betamethasone Dipropionate | Betamethasone Dipropionate | Fougera | Aurobindo | 219348 |
| 01/26/2026 | Lysteda | Tranexamic Acid | Amring | I3 Pharms | 219702 |
| 01/26/2026 | Depo-Medrol | Methylprednisolone Acetate | Pfizer | Caplin | 220556 |
| 01/27/2026 | Nucynta | Tapentadol HCl | Collegium | Humanwell | 214378 |
| 01/27/2026 | Inderal | Propranolol HCl | Wyeth | Mankind | 216663 |
| 01/27/2026 | Emflaza | Deflazacort | PTC | Sun | 219930 |
| 01/27/2026 | Dificid | Fidaxomicin | Cubist | Torrent | 220374 |
| 01/27/2026 | Mesnex | Mesna | Baxter | Eugia | 220518 |
| 01/28/2026 | Sertraline HCl | Sertraline HCl | Almatica | SKG | 219655 |
| 01/29/2026 | Edurant | Rilpivirine HCl | Janssen | Somerset | 218798 |
| 01/29/2026 | Sertraline HCl | Sertraline HCl | Almatica | Zydus | 220275 |
| 01/29/2026 | Vimpat | Lacosamide | UCB | Regcon Holdings | 220386 |
| 01/30/2026 | Odefsev | Emtricitabine / Rilpivirine HCl / Tenofovir Alafenamide Fumarate | Gilead | Apotex | 214095 |
| 02/02/2026 | Revlimid | Lenalidomide | Bristol Myers Squibb | Cipla | 213165 |
| 02/02/2026 | Estrogel | Estradiol | Ascend | Long Grove | 215096 |
| 02/02/2026 | Dificid | Fidaxomicin | Cubist | Apotex | 219559 |
| 02/02/2026 | Remeron | Mirtazapine | Organon | Novitium | 219919 |
| 02/03/2026 | Selenious Acid | Selenious Acid | American Regent | Kindos | 219472 |
| 02/03/2026 | Doxil | Doxorubicin HCl | Baxter | Qilu Pharm Hainan | 219881 |
| 02/04/2026 | Paraplatin | Carboplatin | CordenPharma | Qilu Pharm Hainan | 219999 |
| 02/05/2026 | Azactam | Aztreonam | Bristol Myers Squibb | Hikma | 207069 |
| 02/05/2026 | Bumex | Bumetanide | Validus | MSN | 215362 |
| 02/05/2026 | Stalevo 50 | Carbidopa / Entacapone / Levodopa | Orion | Alembic | 218535 |
| 02/05/2026 | Motegrity | Prucalopride Succinate | Takeda | Teva | 219071 |
| 02/05/2026 | Solu-Cortef | Hydrocortisone Sodium Succinate | Pharmacia and Upjohn | Apotex | 219856 |
| 02/05/2026 | Zoledronic Acid | Zoledronic Acid | InfoRLife | Gland | 219984 |
| 02/05/2026 | Nilstat | Nystatin | Chartwell | Steranco | 220367 |
| 02/06/2026 | Brilinta | Ticagrelor | AstraZeneca | Mankind | 217679 |
| 02/09/2026 | Lidoderm | Lidocaine | Teikoku | USpharma | 207059 |
| 02/09/2026 | Neptazane | Methazolamide | Lederle | Ajanta | 217408 |
| 02/10/2026 | Nucynta | Tapentadol HCl | Collegium | Hikma | 205057 |
| 02/10/2026 | Retin-A | Tretinoin | Valeant | Encube | 217833 |
| 02/10/2026 | Florinef | Fludrocortisone Acetate | Casper | Hibrow | 220308 |
| 02/11/2026 | Copaxone (20mg/mL) | Glatiramer Acetate | Teva | Hybio | 213382 |
| 02/11/2026 | Copaxone (40mg/mL) | Glatiramer Acetate | Teva | Hybio | 214022 |
| 02/12/2026 | Adquey | Difamilast | Aurobindo | Acrotech | N219474 |
| 02/12/2026 | Lac-Hydrin | Ammonium Lactate | Sun | Zydus | 217815 |
| 02/12/2026 | FML | Fluorometholone | AbbVie | DifGen | 218819 |
| 02/13/2026 | Colcrys | Colchicine | Takeda | Macleods | 210633 |
| 02/13/2026 | Metrogel | Metronidazole | Galderma | Zydus | 220095 |
| 02/17/2026 | Colcrys | Colchicine | Takeda | Micro Labs | 212880 |
| 02/17/2026 | Tracleer | Bosentan | Actelion | Zydus | 213981 |
| 02/17/2026 | Zydelig | Idelalisib | Gilead | Natco | 216921 |
| 02/17/2026 | Buphenyl | Sodium Phenylbutyrate | Horizon | Navinta | 220418 |
| 02/18/2026 | Abilify | Aripiprazole | Otsuka | Aurobindo | 216208 |
| 02/19/2026 | Doxy 100 | Doxycycline Hyclate | Fresenius Kabi | Avet | 203276 |
| 02/19/2026 | Briviact | Brivaracetam | UCB | MSN | 214922 |
| 02/20/2026 | Xarelto | Rivaroxaban | Janssen | InvaGen | 218768 |
| 02/23/2026 | Jublia | Efinaconazole | Bausch | Alembic | 212027 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | Apotex | 214875 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | Micro Labs | 214880 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | MSN | 214924 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | Hainan Poly | 218249 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | Zhejiang Poly | 218494 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | Alkem | 219772 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | Lupin | 220164 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | Regcon Holdings | 220385 |
| 02/23/2026 | Briviact | Brivaracetam | UCB | Centaur | 220470 |
| 02/23/2026 | Atrovent HFA | Ipratropium Bromide | Boehringer Ingelheim | Armstrong | 217953 |
| 02/23/2026 | Sodium Phosphates | Sodium Phosphate, Dibasic, Heptahydrate / Sodium Phosphate, Monobasic, Monohydrate | Hospira | Caplin | 220683 |
| 02/24/2026 | Saxenda | Liraglutide | Novo Nordisk | Biocon | 217063 |
| 02/24/2026 | Saxenda | Liraglutide | Novo Nordisk | Orbicular | 217234 |
| 02/24/2026 | Lyrica | Pregabalin | Upjohn | Fourrts | 218529 |
| 02/24/2026 | Mycamine | Micafungin Sodium | Astellas | Yichang Humanwell | 219518 |
| 02/25/2026 | Lamictal ODT | Lamotrigine | GlaxoSmithKline | Alembic | 217278 |
| 02/25/2026 | Zortress | Everolimus | Novartis | Eugia | 219533 |
| 02/25/2026 | Precedex | Dexmedetomidine HCl | Hospira | Dr. Reddy's Labs | 220315 |
| 02/25/2026 | Cortef | Hydrocortisone | Pharmacia and Upjohn | Appco | 220329 |
| 02/25/2026 | Zyrtec | Cetirizine HCl | Johnson & Johnson | Rubicon | 220335 |
| 02/26/2026 | Phytonadione | Phytonadione | International Medication | Baxter | 216852 |
| 02/26/2026 | Stromectol | Ivermectin | Merck | Zydus | 216863 |
| 02/26/2026 | Dalvance | Dalbavancin HCl | AbbVie | Long Grove | 218602 |
| 02/26/2026 | Dapsone | Dapsone | Everest | Zydus | 220103 |
| 02/26/2026 | Bumex | Bumetanide | Validus | Anthea | 220427 |
| 02/26/2026 | Mephyton | Phytonadione | Bausch | Sinotherapeutics | 220454 |
| 02/27/2026 | Cardizem CD | Diltiazem HCl | Bausch | Macleods | 218744 |
| 02/27/2026 | Rocaltrol | Calcitriol | Esjay | Humanwell | 219796 |
| 02/27/2026 | DDAVP | Desmopressin Acetate | Nordic | Caplin | 219981 |
| 03/02/2026 | Avelox | Moxifloxacin HCl | Bayer | Macleods | 209143 |
| 03/02/2026 | Xarelto | Rivaroxaban | Janssen | Apotex | 218427 |
| 03/02/2026 | Trileptal | Oxcarbazepine | Novartis | Epic | 219556 |
| 03/03/2026 | Flovent HFA | Fluticasone Propionate | Glaxo | Glenmark | 219602 |
| 03/04/2026 | Miacalcin | Calcitonin Salmon | Mylan | Zydus | 215864 |
| 03/04/2026 | Glucotrol | Glipizide | Pfizer | Graviti | 219159 |
| 03/04/2026 | Zemuron | Rocuronium Bromide | Organon | Aspiro | 220124 |
| 03/04/2026 | Complera | Emtricitabine / Rilpivirine HCl / Tenofovir Disoproxil Fumarate | Gilead | Laurus | 220232 |
| 03/05/2026 | Aponvie | Aprepitant | Heron | Mylan | 218851 |
| 03/05/2026 | Questran | Cholestyramine | Bristol Myers Squibb | Micro Labs | 219318 |
| 03/05/2026 | Paxil | Paroxetine HCl | Apotex | Annora | 219954 |
| 03/05/2026 | Motrin | Ibuprofen | Kenvue | Rubicon | 220239 |
| 03/05/2026 | Zyprexa | Olanzapine | Cheplapharm | Anthea | 220323 |
| 03/06/2026 | Aurobindo | Siponimod | Novartis | Aurobindo | 218459 |
| 03/06/2026 | Neurontin | Gabapentin | Viatris | Prinston | 219814 |
| 03/09/2026 | Stromectol | Ivermectin | Merck | E5 Pharma | 216808 |
| 03/09/2026 | Zebeta | Bisoprolol Fumarate | Teva | Micro Labs | 218303 |
| 03/09/2026 | Precedex | Dexmedetomidine HCl | Hospira | Knack | 218675 |
| 03/09/2026 | Pepsid | Famotidine | Salix | Contract Pharmacal | 219603 |
| 03/09/2026 | Trileptal | Oxcarbazepine | Novartis | Steranco | 220281 |
| 03/10/2026 | Pentasa | Mesalamine | Takeda | Difgen | 219997 |
| 03/10/2026 | Pristiq | Desvenlafaxine Succinate | PF Prism | Yichang Humanwell | 220460 |
| 03/11/2026 | Auryxia | Ferric Citrate | Keryx | Teva | 212563 |
| 03/11/2026 | Victoza | Liraglutide | Novo Nordisk | Biocon | 215245 |
| 03/11/2026 | Alphagan P | Brimonidine Tartrate | AbbVie | Gland | 219219 |
| 03/11/2026 | Evoxac | Cevimeline HCl | Cosette | Zydus | 220267 |
| 03/12/2026 | Promethazine and Dextromethorphan | Dextromethorphan Hydrobromide / Promethazine HCl | Ani | Hetero | 218264 |
| 03/12/2026 | Potassium Phosphates | Potassium Phosphate, Dibasic / Potassium Phosphate, Monobasic | Fresenius Kabi | Caplin | 220373 |
| 03/13/2026 | Phytonadione | Phytonadione | International Medication | Orbicular | 216298 |
| 03/13/2026 | Citalopram Hydrobromide | Citalopram Hydrobromide | Almatica | Aurobindo | 219985 |
| 03/16/2026 | Flonase | Fluticasone Propionate | Haleon | Glenmark | 218742 |
| 03/16/2026 | Campral | Acamprosate Calcium | Forest | Appco | 218984 |
| 03/16/2026 | Halaven | Eribulin Mesylate | Esai | Formosa | 219054 |
| 03/16/2026 | Promacta | Eltrombopag Olamine | Novartis | Dr. Reddy's Labs | 219121 |
| 03/17/2026 | Mycamine | Micafungin Sodium | Astellas | Aspiro | 220296 |
| 03/18/2026 | Cleocin T | Clindamycin Phosphate | Pfizer | Aurobindo | 218942 |
| 03/19/2026 | Xifaxan | Rifaximin | Salix | Teva | 208959 |
| 03/19/2026 | Mycobutin | Rifabutin | Pfizer | I3 Pharms | 212430 |
| 03/19/2026 | Valcyte | Valganciclovir HCl | Cheplapharm | Micro Labs | 218838 |
| 03/19/2026 | Ephedrine Sulfate | Ephedrine Sulfate | PH Health | Fresenius Kabi | 219991 |
| 03/19/2026 | Xylocaine | Lidocaine HCl | Fresenius Kabi | Viwit | 220071 |
| 03/20/2026 | Xeljanz | Tofacitinib Citrate | PF Prism | Ajanta | 212943 |
| 03/20/2026 | Xylocaine Viscous | Lidocaine HCl | Fresenius Kabi | Quagen | 218676 |
| 03/23/2026 | Suprax | Cefixime | Lupin | Aurobindo | 217607 |
| 03/23/2026 | Cleocin T | Clindamycin Phosphate | Pfizer | Rising | 218300 |
| 03/23/2026 | Mexitil | Mexiletine HCl | Boehringer Ingelheim | Macleods | 219987 |
| 03/24/2026 | Brilinta | Ticagrelor | AstraZeneca | Zhejiang Jingxin | 219006 |
| 03/24/2026 | Ziac | Bisoprolol Fumarate / Hydrochlorothiazide | Teva | Unique | 219489 |
| 03/24/2026 | Tenex | Guanfacine HCl | Promius | Ascent | 220675 |
| 03/25/2026 | Retin-A | Tretinoin | Valeant | Encube | 217832 |
| 03/26/2026 | Paxil CR | Paroxetine HCl | Apotex | Alembic | 217280 |
| 03/26/2026 | Norepinephrine Bitartrate in 5% Dextrose | Norepinephrine Bitartrate | Baxter | Sagent | 220483 |
| 03/27/2026 | Mavenclad | Cladribine | EMD Serono | Hopewell | 215547 |
| 03/30/2026 | Victoza | Liraglutide | Novo Nordisk | Fresenius Kabi | 212552 |
| 03/30/2026 | Tessalon | Benzonatate | Pfizer | Marksans | 220298 |
| 03/31/2026 | Benicar HCT | Hydrochlorothiazide / Olmesartan Medoxomil | Cosette | Sciegen | 208465 |
| 03/31/2026 | Rowasa | Mesalamine | Cosette | Mylan | 220016 |
