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 # |
| 07/01/2026 | Chlorthalidone | Chlorthalidone | Mylan | Macleods | 212229 |
| 07/01/2026 | Victoza | Liraglutide | Novo Nordisk | Sandoz | 212972 |
| 07/01/2026 | Combigan | Brimonidine Tartrate / Timolol Maleate | AbbVie | Saba İlaç Sanayive | 217934 |
| 07/01/2026 | Briviact | Brivaracetam | UCB | ScieGen | 219952 |
| 07/01/2026 | Xarelto | Rivaroxaban | Janssen | Mankind | 220874 |
| 07/02/2026 | Carnitor | Levocarnitine | Leadiant | Baxter | 217896 |
| 07/06/2026 | Rectiv | Nitroglycerin | AbbVie | Padagis | 214565 |
| 07/06/2026 | Sodium Bicarbonate | Sodium Bicarbonate | Abbott | Milla | 219089 |
| 07/06/2026 | Chantix | Varenicline Tartrate | PF Prism | Somerset | 219382 |
| 07/07/2026 | Morphine Sulfate | Morphine Sulfate | Hikma | Quagen | 213892 |
| 07/07/2026 | Mircette | Desogestrel / Ethinyl Estradiol | Teva | Annora | 219670 |
| 07/07/2026 | Rimso-50 | Dimethyl Sulfoxide | Mylan | Renova | 220173 |
| 07/08/2026 | Akovaz | Ephedrine Sulfate | Exela | Baxter | 216740 |
| 07/08/2026 | Dapsone | Dapsone | Everest | Macleods | 218335 |
| 07/08/2026 | Vibisone | Cyanocobalamin | Fresenius Kabi | Aspiro | 219820 |
| 07/09/2026 | Sodium Bicarbonate | Sodium Bicarbonate | Amneal | Amneal | N220790 |
| 07/09/2026 | Ofev | Nintedanib Esylate | Boehringer Ingelheim | Glenmark | 212555 |
| 07/09/2026 | Magnesium Sulfate | Magnesium Sulfate | Fresenius Kabi | Square | 217461 |
| 07/09/2026 | Ofev | Nintedanib Esylate | Boehringer Ingelheim | Humanwell PuraCap | 218472 |
| 07/10/2026 | Zyogreen | Indocyanine Green | Provepharm | Provepharm | N218579 |
| 07/10/2026 | Ventavis | Iloprost | Actelion | Beloteca | 214997 |
| 07/10/2026 | Edurant | Rilpivirine HCl | Janssen | Laurus | 219788 |
| 07/13/2026 | Promacta | Eltrombopag Olamine | Novartis | Teva | 209938 |
| 07/13/2026 | Xanax | Alprazolam | Upjohn | Unichem | 213204 |
| 07/13/2026 | Briviact | Brivaracetam | UCB | Shandong | 219766 |
| 07/14/2026 | Gilotrif | Afatinib Dimaleate | Boehringer Ingelheim | Apotex | 210725 |
| 07/14/2026 | Gilotrif | Afatinib Dimaleate | Boehringer Ingelheim | Hetero | 210750 |
| 07/14/2026 | Diprivan | Propofol | Fresenius Kabi | Anthea | 220857 |
| 07/15/2026 | Lodine | Etodolac | Wyeth | Aurobindo | 214872 |
| 07/16/2026 | Stie-Cort | Hydrocortisone | Padagis | Rising | 218298 |
| 07/17/2026 | Bentyl | Dicyclomine HCl | Allergan | Rubicon | 216515 |
| 07/20/2026 | Kyprolis | Carfilzomib | Onyx | MSN | 209526 |
| 07/21/2026 | Wellbutrin XL | Bupropion HCl | Bausch | Aurobindo | 216051 |
| 07/21/2026 | Tolvaptan | Tolvaptan | Otsuka | Teva | 216933 |
| 07/21/2026 | Wakix | Pitolisant HCl | Harmony | Novitium | 218495 |
| 07/21/2026 | Luvox CR | Fluvoxamine Maleate | Jazz | Zydus | 220447 |
| 07/22/2026 | Epiduo Forte | Adapalene / Benzoyl Peroxide | Galderma | Aurobindo | 217384 |
| 07/22/2026 | Radicava | Edaravone | Shionogi | Zydus | 218349 |
| 07/22/2026 | Isoptin | Verapamil HCl | MT Adams | Knack | 220076 |
| 07/22/2026 | Trokendi XR | Topiramate | Supernus | Biocon | 220943 |
| 07/23/2026 | Fludarabine Phosphate | Fludarabine Phosphate | Caplin One | Hisun | 220196 |
| 07/24/2026 | Tylenol with Naproxen | Acetaminophen / Naproxen Sodium | Kenvue | Kenvue | N219962 |
| 07/27/2026 | Advair Diskus | Fluticasone Propionate / Salmeterol Xinafoate | Glaxo | Cipla | 213087 |
| 07/27/2026 | Motegrity | Prucalopride Succinate | Takeda | Alembic | 219234 |
| 07/27/2026 | Diazepam | Diazepam | RegCon | Lupin | 220365 |
| 07/28/2026 | Gwyn Lo | Ethinyl Estradiol / Norelgestromin | Viatris | Viatris | N219990 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Mylan | 213915 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Teva | 214126 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Mankind | 214230 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Dr. Reddy's Labs | 214236 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Zenara | 214306 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Sandoz | 214311 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Sun | 214319 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Lupin | 214338 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Gland | 214364 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | MSN | 214368 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Tamarang | 215260 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Qilu | 215575 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Hikma | 218727 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Hikma | 218728 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Steriscience | 218814 |
| 07/28/2026 | Bridion | Sugammadex Sodium | Merck | Fresenius Kabi | 219448 |
| 07/28/2026 | Valium | Diazepam | Hoffman-LaRoche | Baxter | 219882 |
| 07/28/2026 | Ravicti | Glycerol Phenylbutyrate | Horizon | Esjay | 220579 |
| 07/29/2026 | Glycophos | Sodium Glycerophosphate | Fresenius Kabi | Fresenius Kabi | N220381 |
| 07/29/2026 | Qlonilik | Clonidine HCl | CMP | CMP | N221094 |
| 07/29/2026 | Tikosyn | Dofetilide | Pfizer | Innogenix | 212496 |
| 07/29/2026 | Miralax | Polyethylene Glycol 3350 | Bayer | LNK International | 217505 |
| 07/30/2026 | Ascor | Ascorbic Acid | McGuff | Stira | 220172 |
| 07/30/2026 | Allegra Allergy | Fexofenadine HCl | Chattem Sanofi | Dr. Reddy's Labs | 220413 |
| 07/31/2026 | Epinephrine | Epinephrine | BPI | Deva | 217426 |
| 07/31/2026 | Atropine Sulfate | Atropine Sulfate | Rising | Gland | 219996 |
| 07/31/2026 | Abreva | Docosanol | Haleon | KLM | 220017 |
| 07/31/2026 | Thiamine HCl | Thiamine HCl | Fresenius Kabi | Mankind | 220513 |
| 08/03/2026 | IC-Green | Indocyanine Green | Renew | Zydus | 219139 |
| 08/03/2026 | Ofev | Nintedanib Esylate | Boehringer Ingelheim | Macleods | 219926 |
| 08/04/2026 | Cardene | Nicardipine HCl | Chiesi | Fresenius Kabi | 219334 |
| 08/04/2026 | Entresto | Sacubitril / Valsartan | Novartis | Umedica | 219946 |
| 08/05/2026 | Ranexa | Ranolazine | Menarini | Umedica | 214551 |
| 08/05/2026 | Aptiom | Eslicarbazepine Acetate | Sumitomo | Aurobindo | 216481 |
| 08/06/2026 | Keppra | Levetiracetam | UCB | Baxter | 208458 |
| 08/06/2026 | Claritin-D | Loratadine / Pseudoephedrine Sulfate | Bayer | Dr. Reddy's Labs | 220448 |
| 08/07/2026 | Onexton | Benzoyl Peroxide / Clindamycin Phosphate | Bausch | Actavis | 208757 |
| 08/07/2026 | Lokelma | Sodium Zirconium Cyclosilicate | AstraZeneca | Lupin | 217549 |
| 08/07/2026 | Firvanq kit | Vancomycin HCl | Azurity | Aurobindo | 218130 |
| 08/10/2026 | Dotarem | Gadoterate Meglumine | Guerbet | Viwit | 219286 |
| 08/10/2026 | Briviact | Brivaracetam | UCB | Aurobindo | 220288 |
| 08/11/2026 | Diovan | Valsartan | Novartis | Bostal | 205357 |
| 08/11/2026 | Nasacort Allergy 24 Hour | Triamcinolone Acetonide | Chattem Sanofi | Aurobindo | 220110 |
| 08/12/2026 | Monurol | Fosfomycin Tromethamine | Zambon | Novitium | 210426 |
| 08/13/2026 | Dificid | Fidaxomicin | Cubist | Sandoz | 220465 |
| 08/14/2026 | Sodium Bicarbonate | Sodium Bicarbonate | Baxter | Baxter | N218524 |
| 08/14/2026 | Cabometyx | Cabozantinib S-Malate | Exelixis | MSN | 213878 |
| 08/14/2026 | Wakix | Pitolisant HCl | Harmony | Lupin | 218846 |
| 08/14/2026 | Wakix | Pitolisant HCl | Harmony | MSN | 218873 |
| 08/14/2026 | Inderal LA | Propranolol HCl | ANI | Creekwood | 219460 |
| 08/14/2026 | Sehippy | Vortioxetine | Seasons | Seasons | N218328 |
| 08/17/2026 | Xeljanz XR | Tofacitinib Citrate | Pfizer | Teva | 209813 |
| 08/17/2026 | Adcirca | Tadalafil | Eli Lilly | Jubilant | 210592 |
| 08/18/2026 | Flonase | Fluticasone Propionate | Haleon | Glenmark | 219232 |
| 08/18/2026 | Naloxone HCl | Naloxone HCl | Hospira | Sterinova | 219942 |
| 08/19/2026 | Zarelto | Rivaroxaban | Janssen | Epic | 216255 |
| 08/19/2026 | Ofev | Nintedanib Esylate | Boehringer Ingelheim | Biocon | 220118 |
| 08/20/2026 | Qbrelis | Lisinopril | Azurity | Annora | 218419 |
| 08/20/2026 | Brilinta | Ticagrelor | AstraZeneca | Laurus | 218869 |
| 08/20/2026 | Ascor | Ascorbic Acid | McGuff | Zydus | 220873 |
| 08/21/2026 | Nitrolingual Pumpspray | Nitroglycerin | Pohl-Boskamp | Socorro | 204681 |
| 08/21/2026 | Mycobutin | Rifabutin | Pfizer | Zydus | 219519 |
| 08/26/2026 | Vobrig | Leuprolide Acetate | Sun | Sun | N213225 |
| 08/26/2026 | Descovy | Emtricitabine / Tenofovir Alafenamide Fumarate | Gilead | Natco | 214173 |
| 08/27/2026 | Cortisporin | Hydrocortisone / Neomycin Sulfate / Polymyxin B Sulfate | Monarch | Orbicular | 220938 |
| 08/28/2026 | Calcium Gluconate | Calcium Gluconate In Sodium Chloride | Fresenius Kabi | Milla | 219037 |
| 08/31/2026 | Pomalyst | Pomalidomide | Bristol Myers Squibb | Spil | 210232 |
| 08/31/2026 | Pomalyst | Pomalidomide | Bristol Myers Squibb | Dr. Reddy's Labs | 213234 |
| 08/31/2026 | Suprep Bowel Prep Kit | Sodium Sulfate / Potassium Sulfate / Magnesium Sulfate | Azurity | Macleods | 219429 |
| 08/31/2026 | Pomalyst | Pomalidomide | Bristol Myers Squibb | Cipla | 219718 |
| 08/31/2026 | Pomalyst | Pomalidomide | Bristol Myers Squibb | Sandoz | 220741 |
| 08/31/2026 | Korsuva | Difelikefalin Acetate | Vifor | Qilu Pharm Hainan | 220919 |
| 09/02/2026 | Pomalyst | Pomalidomide | Bristol Myers Squibb | MSN | 210245 |
| 09/02/2026 | Entresto | Sacubitril / Valsartan | Novartis | Aurobindo | 213631 |
| 09/02/2026 | Fosamax | Alendronate Sodium | Merck | Precision Dose | 214523 |
| 09/03/2026 | Cabometyx | Cabozantinib Lauryl Sulfate | Exelixis | Handa | N220613 |
| 09/03/2026 | Provigil | Modafinil | Nuvo | Lupin | 208343 |
| 09/03/2026 | Depo-Testosterone | Testosterone Cypionate | Pfizer | BPI | 219478 |
| 09/03/2026 | Nucynta | Tapentadol HCl | Collegium | MSN | 220865 |
| 09/04/2026 | Trokendi XR | Topiramate | Supernus | Micro Labs | 219183 |
| 09/08/2026 | Imbruvica | Ibrutinib | Pharmacyclics | Hetero | 211182 |
| 09/08/2026 | Briviact | Brivaracetam | UCB | Zhejiang Jutai | 220136 |
| 09/10/2026 | Accutane | Isotretinoin | Roche | Aurobindo | 220336 |
| 09/10/2026 | Aldactazide | Hydrochlorothiazide / Spironolactone | Pfizer | Rubicon | 220884 |
| 09/11/2026 | Reglan | Metoclopramide HCl | Hikma | Baxter | 217072 |
| 09/11/2026 | Sprycel | Dasatinib | Bristol Myers Squibb | MSN | 219579 |
| 09/14/2026 | Lutathera | Lutetium Lu-177 Dotatate | Advanced Accelerator Applications | Curium | N218525 |
| 09/14/2026 | Qvar | Beclomethasone Dipropionate | Teva | Aurobindo | 214418 |
| 09/14/2026 | Haldol | Haloperidol | Ortho McNeil | Ajanta | 218210 |
| 09/14/2026 | Adrenalin | Epinephrine | PH Health | Zydus | 219832 |
| 09/14/2026 | Femara | Letrozole | Novartis | Zydus | 220438 |
| 09/15/2026 | Savella | Milnacipran HCl | AbbVie | Strides | 207399 |
| 09/15/2026 | Savella | Milnacipran HCl | AbbVie | Macleods | 210944 |
| 09/15/2026 | Retin-A | Tretinoin | Bausch | Zydus | 218560 |
| 09/15/2026 | Adrenalin | Epinephrine | PH Health | Difgen | 220657 |
| 09/17/2026 | Calcium Gluconate | Calcium Gluconate | HQ Specialty | Cipla | 217891 |
| 09/17/2026 | Neoral | Cyclosporine | Novartis | Aurobindo | 219652 |
| 09/18/2026 | Somatuline Depot | Lanreotide Acetate | Ipsen | Amneal | 218217 |
| 09/18/2026 | Zemuron | Rocuronium Bromide | Organon | Baxter | 219260 |
| 09/18/2026 | Emflaza | Deflazacort | PTC | Hikma | 220524 |
| 09/21/2026 | Lutathera | Lutetium Lu-177 Dotatate | Novartis | Lantheus Medical | 217060 |
| 09/21/2026 | Afinitor Disperz | Everolimus | Novartis | Novitium | 220597 |
| 09/22/2026 | Norvasc | Amlodipine Besylate | Viatris | Ipca | 210489 |
| 09/22/2026 | Jardiance | Empagliflozin | Boehringer Ingelheim | Invagen | 212330 |
| 09/22/2026 | Hycodan | Homatropine Methylbromide / Hydrocodone Bitartrate | Genus | Senores | 220509 |
| 09/23/2026 | Mexitil | Mexiletine HCl | Boehringer Ingelheim | Zydus | 214598 |
| 09/23/2026 | Toradol | Ketorolac Tromethamine | Roche | Shandong | 218355 |
| 09/23/2026 | Ortho Tri-Cyclen | Ethinyl Estradiol / Norgestimate | Janssen | Annora | 220876 |
| 09/24/2026 | Linzess | Linaclotide | AbbVie | Actavis | 211255 |
| 09/24/2026 | Phenylephrine HCl | Phenylephrine HCl | Hikma | Nephron | 215268 |
| 09/24/2026 | Eucrisa | Crisaborole | Anacor | Macleods | 216242 |
| 09/25/2026 | Lamlique | Lamotrigine Hemifumarate | Azurity | Azurity | N221109 |
| 09/25/2026 | Zueino | Diclofenac Sodium | Adventa | Adventa | N218379 |
| 09/25/2026 | Unipen | Nafcillin Sodium | Wyeth | Steriscience | 203830 |
| 09/25/2026 | Thiamine HCl | Thiamine HCl | Fresenius Kabi | Hong Kong | 213131 |
| 09/25/2026 | Metrogel | Metronidazole | Bausch | Aurobindo | 218485 |
| 09/25/2026 | Nexium | Esomeprazole Magnesium | AstraZeneca | Novitium | 218687 |
| 09/25/2026 | Cardizem | Diltiazem HCl | Bausch | Yichang Humanwell | 220590 |
| 09/25/2026 | Toradol | Ketorolac Tromethamine | Roche | Adaptis | 221041 |
| 09/28/2026 | Pred Forte | Prednisolone Acetate | AbbVie | Upsher Smith | 212778 |
| 09/28/2026 | Precedex | Dexmedetomidine HCl | Hospira | Nephron | 216254 |
| 09/29/2026 | Bactroban | Mupirocin Calcium | GlaxoSmithKline | Zydus | 218361 |
| 09/30/2026 | Aquamephyton | Phytonadione | PAI | Lupin | 219175 |
| 09/30/2026 | Carnitor | Levocarnitine | Leadiant | Gland | 220181 |
| 09/30/2026 | Loperamide HCl | Loperamide HCl | Bionpharma | Taro | 220722 |
