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 # |
| 04/02/2026 | Ofev | Nintedanib Esylate | Boehringer-Ingelheim | Cipla | 212609 |
| 04/02/2026 | Ofev | Nintedanib Esylate | Boehringer-Ingelheim | Sandoz | 216915 |
| 04/02/2026 | Ofev | Nintedanib Esylate | Boehringer-Ingelheim | Apotex | 219227 |
| 04/02/2026 | Ofev | Nintedanib Esylate | Boehringer-Ingelheim | Dr. Reddy's Labs | 219283 |
| 04/02/2026 | Ofev | Nintedanib Esylate | Boehringer-Ingelheim | Dexcel | 219819 |
| 04/03/2026 | Qbrexza | Glycopyrronium Tosylate | Journey | Padagis | 214448 |
| 04/03/2026 | Phenylephrine Hydrochloride | Phenylephrine HCl | Akorn | Baxter | 217032 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Inventia | 211156 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Sandoz | 211312 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | Micro Labs | 211466 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Micro Labs | 211467 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Aurobindo | 211468 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Biocon | 211470 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | MSN | 211478 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | MSN | 211479 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Ajanta | 211482 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | Aurobindo | 211489 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Macleods | 211506 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Aizant | 211523 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Lupin | 211531 |
| 04/06/2026 | Qtern | Dapagliflozin / Saxagliptin HCl | AstraZeneca | MSN | 211533 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Cipla | 211535 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | Cipla | 211536 |
| 04/06/2026 | Qtern | Dapagliflozin / Saxagliptin HCl | AstraZeneca | Torrent | 211537 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Teva | 211541 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Alkem | 211545 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | Macleods | 211559 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Alembic | 211560 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | Alkem | 211563 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | Lupin | 211579 |
| 04/06/2026 | Farxiga | Dapagliflozin | AstraZeneca | Zydus | 211582 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | Teva | 211583 |
| 04/06/2026 | Xigduo XR | Dapagliflozin / Metformin HCl | AstraZeneca | Cipla | 211595 |
| 04/07/2026 | Descovy | Emtricitabine / Tenofovir Alafenamide Fumarate | Gilead | Macleods | 214216 |
| 04/07/2026 | Stromectol | Ivermectin | Merck Sharp Dohme | Ajanta | 218509 |
| 04/07/2026 | Macrobid | Nitrofurantoin / Nitrofurantoin Macrocrystalline | Almatica | Creekwood | 220269 |
| 04/08/2026 | Endometrin | Progesterone | Ferring | Glenmark | 216363 |
| 04/08/2026 | Ocuflox | Ofloxacin | Allergan | Micro Labs | 218557 |
| 04/08/2026 | Promacta | Eltrombopag Olamine | Novartis | Hikma | 220033 |
| 04/09/2026 | Infuvite Adult Injection | Alpha-Tocopherol Acetate / Ascorbic Acid / Biotin / Cholecalciferol / Cyanocobalamin / Dexpanthenol / Folic Acid / Niacinamide / Pyridoxine HCl / Riboflavin 5'-Phosphate Sodium / Thiamine HCl; Vitamin A Palmitate / Vitamin K | Sandoz | Apotex | 210273 |
| 04/09/2026 | Infuvite Adult Injection | Alpha-Tocopherol Acetate / Ascorbic Acid / Biotin / Cholecalciferol / Cyanocobalamin / Dexpanthenol / Folic Acid / Niacinamide / Pyridoxine HCl / Riboflavin 5'-Phosphate Sodium / Thiamine HCl; Vitamin A Palmitate / Vitamin K | Sandoz | Apotex | 210672 |
| 04/09/2026 | Monurol | Fosfomycin Tromethamine | Zambon | Aucta | 217772 |
| 04/13/2026 | Benicar HCT | Hydrochlorothiazide / Olmesartan Medoxomil | Cosette | Micro Labs | 206371 |
| 04/13/2026 | Orap | Pimozide | Teva | Novitium | 219897 |
| 04/14/2026 | Invokana | Canagliflozin | Janssen | Apotex | 210449 |
| 04/15/2026 | Precedex | Dexmedetomidine HCl | Hospira | Baxter | 208103 |
| 04/15/2026 | Delsym | Dextromethorphan Polistirex | RB Health | Aurobindo | 218417 |
| 04/15/2026 | Ravicti | Glycerol Phenylbutyrate | Horizon | Teva | 218738 |
| 04/15/2026 | Atropine Sulfate | Atropine Sulfate | Rising | Edenbridge | 219013 |
| 04/15/2026 | Ravicti | Glycerol Phenylbutyrate | Horizon | MSN | 219540 |
| 04/15/2026 | Methotrexate Sodium | Methotrexate Sodium | Hospira | Alembic | 220225 |
| 04/15/2026 | Ravicti | Glycerol Phenylbutyrate | Horizon | Aurobindo | 220313 |
| 04/15/2026 | Sodium Bicarbonate | Sodium Bicarbonate | Exela | Aspiro | 220788 |
| 04/16/2026 | Uptravi | Selexipag | Actelion | RK Pharma | 214055 |
| 04/16/2026 | Alphagan P | Brimonidine Tartrate | AbbVie | Mankind | 220398 |
| 04/17/2026 | Sodium Acetate | Sodium Acetate | Hospira | Extrovis | 220274 |
| 04/20/2026 | Invokana | Canagliflozin | Johnson & Johnson | Aurobindo | 210386 |
| 04/20/2026 | Esbriet | Pirfenidone | Legacy | Aurobindo | 212597 |
| 04/20/2026 | Xtandi | Enzalutamide | Astellas | Sandoz | 216068 |
| 04/21/2026 | Infuvite Pediatric | Ascorbic Acid / Biotin / Cholecalciferol / Cyanocobalamin / Dexpanthenol / Folic Acid / Niacinamide / Pyridoxine / Riboflavin / Thiamine / Tocopherol Acetate / Vitamin A / Vitamin K | Sandoz | Apotex | 210456 |
| 04/21/2026 | Infuvite Pediatric | Ascorbic Acid / Biotin / Cholecalciferol / Cyanocobalamin / Dexpanthenol / Folic Acid / Niacinamide / Pyridoxine / Riboflavin / Thiamine / Tocopherol Acetate / Vitamin A / Vitamin K | Sandoz | Apotex | 210671 |
| 04/21/2026 | Diovan | Valsartan | Novartis | Laurus | 218897 |
| 04/21/2026 | Jynarque | Tolvaptan | Otsuka | Alkem | 220147 |
| 04/22/2026 | Lexapro | Escitalopram Oxalate | AbbVie | Micro Labs | 91655 |
| 04/22/2026 | Tambocor | Flecainide Acetate | Alvogen | OMSAV | 218093 |
| 04/22/2026 | Ventolin HFA | Albuterol Sulfate | GlaxoSmithKline | Cipla | 219409 |
| 04/22/2026 | Protonix IV | Pantoprazole Sodium | Wyeth | Shuangcheng | 219973 |
| 04/22/2026 | Sensorcaine | Bupivacaine HCl | Fresenius Kabi | Anthea | 220493 |
| 04/23/2026 | Diovan HCT | Hydrochlorothiazide / Valsartan | Novartis | ScieGen | 204687 |
| 04/23/2026 | Symbicort | Budesonide / Formoterol Fumarate Dihydrate | AstraZeneca | Teva | 212212 |
| 04/23/2026 | Ravicti | Glycerol Phenylbutyrate | Horizon | Navinta | 220568 |
| 04/24/2026 | Gilenya | Fingolimod HCl | Novartis | Alembic | 207974 |
| 04/24/2026 | Thalomid | Thalidomide | Bristol Myers Squibb | Natco | 213267 |
| 04/27/2026 | Brilinta | Ticagrelor | AstraZeneca | Micro Labs | 208539 |
| 04/28/2026 | Zonalon | Doxepin HCl | Mylan | Sun | 213919 |
| 04/28/2026 | Promacta | Eltrombopag Olamine | Novartis | Biocon | 220660 |
| 04/29/2026 | Trileptal | Oxcarbazepine | Novartis | Umedica | 218341 |
| 04/29/2026 | Cetrotide | Cetrorelix Acetate | EMD Serono | Epic | 218740 |
| 04/30/2026 | Janumet | Metformin HCl / Sitagliptin Phosphate | Merck | Apotex | 202426 |
| 04/30/2026 | Ravicti | Glycerol Phenylbutyrate | Horizon | Lupin | 207694 |
| 04/30/2026 | Lyrica | Pregabalin | Upjohn | Unichem | 219593 |
| 04/30/2026 | Methotrexate Sodium | Methotrexate Sodium | Hospira | Hetero | 219865 |
| 04/30/2026 | Ak-Fluor 10% | Fluorescein Sodium | Long Grove | BPI Labs | 220046 |
| 04/30/2026 | Luvox CR | Fluvoxamine Maleate | Jazz | Appco | 220328 |
| 05/01/2026 | Evdi | Trabectedin | Janssen | Apotex | N220837 |
| 05/01/2026 | Inderal LA | Propranolol HCl | ANI | Ipca | 203103 |
| 05/01/2026 | Demadex | Torsemide | PharmObediant | Micro Labs | 217239 |
| 05/01/2026 | Myrbetriq | Mirabegron | Apgdi | Deva | 219941 |
| 05/04/2026 | Calcium Gluconate | Calcium Gluconate | Fresenius Kabi | Caplin | 218840 |
| 05/04/2026 | Wellbutrin SR | Bupropion HCl | GlaxoSmithKline | Yichang Humanwell | 220529 |
| 05/05/2026 | Vfend | Voriconazole | Pfizer | Zhejiang Novus | 220078 |
| 05/06/2026 | Vasostrict | Vasopressin | PH Health | Sandoz | 212068 |
| 05/06/2026 | Vasostrict | Vasopressin | PH Health | Sandoz | 212069 |
| 05/07/2026 | Invega | Paliperidone | Johnson & Johnson | i3 Pharmaceutical | 205402 |
| 05/07/2026 | Solu-Cortef | Hydrocortisone Sodium Succinate | Pharmacia and Upjohn | Zydus | 217191 |
| 05/07/2026 | Alphagan P | Brimonidine Tartrate | AbbVie | Micro Labs | 218558 |
| 05/08/2026 | Levetiracetam in Sodium Chloride | Levetiracetam | HQ Specialty | Mylan | 218364 |
| 05/11/2026 | Estrogel | Estradiol | Ascend | Encube | 218214 |
| 05/12/2026 | Pepcid | Famotidine | Merck | Lupin | 217432 |
| 05/12/2026 | Afinitor | Everolimus | Novartis | Apotex | 218488 |
| 05/12/2026 | Zolpidem Tartrate | Zolpidem Tartrate | Almatica | Umedica | 220717 |
| 05/13/2026 | Foscavir | Foscarnet Sodium | Clinigen | Caplin | 220068 |
| 05/14/2026 | Retin-A-Micro | Tretinoin | Bausch | Amneal | 217497 |
| 05/14/2026 | Suprax | Cefixime | Lupin | FDC | 218691 |
| 05/14/2026 | Gallium Ga-68 Gozetotide | Gallium Ga-68 Gozetotide | UCSF | Ionetix | 219189 |
| 05/14/2026 | Endari | L-Glutamine | Emmaus | Renova | 219750 |
| 05/15/2026 | Cialis | Tadalafil | Eli Lilly | Jubilant | 210329 |
| 05/15/2026 | Venclexta | Venetoclax | AbbVie | Dr. Reddy's Labs | 214733 |
| 05/15/2026 | Phytonadione | Phytonadione | International Medication | Dr. Reddy's Labs | 215820 |
| 05/15/2026 | Lac-Hydrin | Ammonium Lactate | Sun | Zydus | 217758 |
| 05/15/2026 | Clomid | Clomiphene Citrate | Sanofi | Ascent | 220673 |
| 05/18/2026 | Cuvposa | Glycopyrrolate | Merz | Quagen | 216910 |
| 05/18/2026 | Isuprel | Isoproterenol HCl | Bausch | Aspiro | 220299 |
| 05/19/2026 | Remeron | Mirtazapine | Organon | Micro Labs | 220104 |
| 05/20/2026 | Synthroid | Levothyroxine Sodium | AbbVie | Alembic | 216370 |
| 05/21/2026 | Klonopin | Clonazepam | Roche | Rubicon | 216988 |
| 05/21/2026 | Vimpat | Lacosamide | UCB | Steranco | 220366 |
| 05/22/2026 | Differin Epiduo | Adapalene / Benzoyl Peroxide | Galderma | Galderma | N220736 |
| 05/26/2026 | Xopenex | Levalbuterol HCl | Hikma | Nephron | 215217 |
| 05/26/2026 | Endari | L-Glutamine | Emmaus | Annora | 219722 |
| 05/26/2026 | Qudexy XR | Topiramate | Upsher-Smith | RiconPharma | 220041 |
| 05/27/2026 | Tradjenta | Linagliptin | Boehringer-Ingelheim | Teva | 208433 |
| 05/27/2026 | Hemabate | Carboprost Tromethamine | Pfizer | Somerset | 219529 |
| 05/27/2026 | Hyzaar | Hydrochlorothiazide / Losartan Potassium | Organon | Hetero | 219869 |
| 05/28/2026 | Sutab | Magnesium Sulfate / Potassium Chloride / Sodium Sulfate | Azurity | Lupin | 216095 |
| 05/28/2026 | Emflaza | Deflazacort | PTC | Biocon | 220709 |
| 05/29/2026 | Trileptal | Oxcarbazepine | Novartis | MSN | 209020 |
| 05/29/2026 | Epinephrine | Epinephrine | BPI Labs | Hikma | 220562 |
| 06/01/2026 | Halaven | Eribulin Mesylate | Esai | Natco | 217085 |
| 06/01/2026 | Vitamin K1 | Phytonadione | Hospira | Amneal | 217734 |
| 06/01/2026 | CellCept | Mycophenolate Mofetil | Roche | Concord Biotech | 218566 |
| 06/01/2026 | Ak-Fluor 10% | Fluorescein Sodium | Long Grove | Zydus | 218651 |
| 06/01/2026 | Restasis | Cyclosporine | AbbVie | Jiangsu Anbison | 219288 |
| 06/02/2026 | Viberzi | Eluxadoline | AbbVie | Aurobindo | 213511 |
| 06/02/2026 | Romidepsin | Romidepsin | Teva | Amneal | 219099 |
| 06/02/2026 | Tiocystin | Tiopronin | Casper | Casper | N212927 |
| 06/03/2026 | Nuedexta | Dextromethorphan Hydrobromide / Quinidine Sulfate | Otsuka | Sun | 204196 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Breckenridge | 209633 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Micro Labs | 209738 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Aurobindo | 215356 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | MSN | 217298 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | MSN | 217299 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Apotex | 218096 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Sun | 218407 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | SpecGx | 219395 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Macleods | 219530 |
| 06/03/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Somerset | 220137 |
| 06/03/2026 | Xeljanz XR | Tofacitinib Citrate | Pfizer | Apotex | 220458 |
| 06/04/2026 | Kengreal | Cangrelor | Chiesi | MSN | 213703 |
| 06/04/2026 | Haldol | Haloperidol | Ortho-McNeil | Alembic | 214470 |
| 06/04/2026 | Rozerem | Ramelteon | Takeda | Hibrow | 215485 |
| 06/04/2026 | Dalvance | Dalbavancin HCl | AbbVie | BE Pharmaceuticals | 219604 |
| 06/05/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Zydus | 209829 |
| 06/08/2026 | Opsumit | Macitentan | Actelion | Amneal | 211000 |
| 06/08/2026 | Opsumit | Macitentan | Actelion | Teva | 211187 |
| 06/08/2026 | Gallium Ga-68 Gozetotide | Gallium Ga-68 Gozetotide | UCSF | RadioMedix | 216410 |
| 06/08/2026 | Gadavist | Gadobutrol | Bayer | Zenara | 219146 |
| 06/09/2026 | Keflex | Cephalexin | Pragma | Aurobindo | 213568 |
| 06/09/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | YaoPharma | 215552 |
| 06/09/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Concord Biotech | 218821 |
| 06/09/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Saptalis | 218900 |
| 06/09/2026 | Xeljanz | Tofacitinib Citrate | Pfizer | Auson | 219370 |
| 06/09/2026 | Xeljanz XR | Tofacitinib Citrate | Pfizer | Orient | 219830 |
| 06/10/2026 | Propranolol HCl | Propranolol HCl | Wyeth | PAI Holdings | 219165 |
| 06/11/2026 | Retin-A | Tretinoin | Valeant | Alembic | 214590 |
| 06/11/2026 | Levophed | Norepinephrine Bitartrate | Hospira | Nephron | 216272 |
| 06/11/2026 | Combigan | Brimonidine Tartrate / Timolol Maleate | AbbVie | Gland | 219166 |
| 06/11/2026 | Gadavist | Gadobutrol | Bayer | Viwit | 219287 |
| 06/11/2026 | Hydroxyzine HCl | Hydroxyzine HCl | Chartwell | Saptalis | 220271 |
| 06/12/2026 | Bosulif | Bosutinib Monohydrate | Pfizer | MSN | 209624 |
| 06/15/2026 | Victoza | Liraglutide | Novo Nordisk | Mylan | 213155 |
| 06/15/2026 | Vimpat | Lacosamide | UBC | Product Development Partners | 217596 |
| 06/15/2026 | Fycompa | Perampanel | Catalyst | Taro | 219052 |
| 06/15/2026 | Dostinex | Cabergoline | Pfizer | Renata | 220309 |
| 06/16/2026 | Aprepitant | Aprepitant | Azurity | Azurity | N218754 |
| 06/16/2026 | Rextovy | Naloxone HCl | Amphastar | Amphastar | N208969 |
| 06/16/2026 | Strattera | Atomoxetine HCl | Eli Lilly | Creekwood | 218875 |
| 06/17/2026 | Promacta | Eltrombopag Olamine | Novartis | Actavis | 208815 |
| 06/17/2026 | Tavalisse | Fostamatinib Disodium | Rigel | Annora | 217329 |
| 06/17/2026 | Xofluza | Baloxavir Marboxil | Genentech | Norwich | 217449 |
| 06/17/2026 | Sunosi | Solriamfetol HCl | Axsome | Hikma | 218016 |
| 06/17/2026 | Sunosi | Solriamfetol HCl | Axsome | Alkem | 218722 |
| 06/17/2026 | Diphenhydramine HCl | Diphenhydramine HC. | Pharmaceutial Associates | Annora | 219470 |
| 06/22/2026 | Lo Loestrin FE | Ethinyl Estradiol / Norethindrone Acetate | APIL | Teva | 219324 |
| 06/23/2026 | Gralise | Gabapentin | Almatica | Actavis | 203611 |
| 06/23/2026 | Priftin | Rifapentine | Sanofi | Macleods | 217042 |
| 06/23/2026 | Wellbutrin SR | Bupropion HCl | GlaxoSmithKline | Macleods | 218567 |
| 06/23/2026 | Luvox CR | Fluvoxamine Maleate | Jazz | Micro Labs | 220768 |
| 06/23/2026 | Dextromethorphan Hydrobromide / Promethazine HCl | Dextromethorphan Hydrobromide / Promethazine HCl | ANI | Rubicon | 220869 |
| 06/24/2026 | Navitrux | Fosaprepitant | Avyxa | Avyxa | N220436 |
| 06/24/2026 | Inderal LA | Propranolol HCl | ANI | Micro Labs | 217238 |
| 06/24/2026 | Vascepa | Icosapent Ethyl | Amarin | Aurobindo | 218949 |
| 06/25/2026 | Injectafer | Ferric Carboxymaltose | American Regent | Mylan | 212572 |
| 06/25/2026 | Aczone | Dapsone | Almirall | Alembic | 213414 |
| 06/25/2026 | Injectafer | Ferric Carboxymaltose | American Regent | Mylan | 217769 |
| 06/25/2026 | Tamiflu | Oseltamivir Phosphate | Roche | Alembic | 218307 |
| 06/25/2026 | Xeljanz XR | Tofacitinib Citrate | Pfizer | ScieGen | 220972 |
| 06/26/2026 | Tasigna | Nilotinib HCl | Novartis | Teva | 219134 |
| 06/26/2026 | Qdolo | Tramadol HCl | Rosemont | Novitium | 219647 |
| 06/29/2026 | Noxafil | Posaconazole | Merck | Apotex | 213331 |
| 06/29/2026 | Gadavist | Gadobutrol | Bayer | GE Healthcare | 215957 |
| 06/29/2026 | Motegrity | Prucalopride Succinate | Takeda | Micro Labs | 219180 |
| 06/29/2026 | Rifadin | Rifampin | Sanofi | Novitium | 219918 |
| 06/30/2026 | Differin | Adapalene | Galderma | Unique | 219565 |
| 06/30/2026 | Xarelto | Rivaroxaban | Janssen | Micro Labs | 208334 |
| 06/30/2026 | Selenious Acid | Selenious Acid | American Regent | Zydus | 219322 |
| 06/30/2026 | Zortress | Everolimus | Novartis | i3 Pharmaceutical | 219464 |
