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ANDA Approvals
New Drug Applications and 505(b)(2) Applications
First Quarter
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 # |
|---|---|---|---|---|---|
| 01/02/2024 | Vfend | Voriconazole | Pfizer | Hainan Poly | 216805 |
| 01/03/2024 | Arranon | Nelarabine | Sandoz | Gland Pharma | 212605 |
| 01/03/2024 | Minipress | Prazosin HCl | Pfizer | Lannett | 214083 |
| 01/04/2024 | Lunesta | Eszopiclone | Woodward | Hetero Labs | 205504 |
| 01/04/2024 | Paxil CR | Paroxetine HCl | Apotex | Prinston | 209748 |
| 01/05/2024 | Tasigna | Nilotinib HCl | Novartis | Apotex | 203640 |
| 01/05/2024 | Lipitor | Atorvastatin Calcium | Upjohn | Mankind Pharma | 217081 |
| 01/05/2024 | Cellcept | Mycophenolate Mofetil | Roche Palo | Aurobindo | 217828 |
| 01/05/2024 | Floxin Otic | Ofloxacin | Daiichi | Caplin | 217903 |
| 01/08/2024 | Epaned | Enalapril Maleate | Azurity | Aurobindo | 216458 |
| 01/08/2024 | Atropine Sulphate | Atropine Sulfate | Rising | Mankind Pharma | 218148 |
| 01/09/2024 | Toviaz | Fesoterodine Fumarate | Pfizer | Hetero Labs | 204792 |
| 01/09/2024 | Opsumit | Macitentan | Actelion | Apotex | 211195 |
| 01/09/2024 | FML | Fluorometholone | AbbVie | Amneal | 216348 |
| 01/10/2024 | Cardura | Doxazosin Mesylate | Viatris | Unichem | 212329 |
| 01/10/2024 | Lioresal | Baclofen | Novartis | Graviti Pharms | 217788 |
| 01/11/2024 | Eloxatin | Oxaliplatin | Sanofi Aventis | Kindos | 217348 |
| 01/12/2024 | Inderal LA | Propranolol HCl | ANI Pharms | Lupin | 204349 |
| 01/12/2024 | Rocephin | Ceftriaxone Sodium | Hoffmann La Roche | Deva Holding | 210197 |
| 01/12/2024 | Indocin | Indomethacin | Zyla | Novitium Pharma | 217883 |
| 01/16/2024 | Dificid | Fidaxomicin | Cubist Pharms | Actavis | 208443 |
| 01/16/2024 | Nuplazid | Pimavanserin Tartrate | Acadia Pharms | Zydus | 214493 |
| 01/16/2024 | Pepcid | Famotidine | Salix | Cerovene | 217605 |
| 01/17/2024 | Uloric | Febuxostat | Takeda | Lupin | 205406 |
| 01/17/2024 | Carafate | Sucralfate | AbbVie | PD Partners | 213549 |
| 01/17/2024 | Bidil | Hydralazine HCl / Isosorbide Dinitrate | Azurity | I3 Pharms | 215988 |
| 01/17/2024 | Neurontin | Gabapentin | Viatris | Annora Pharma | 217682 |
| 01/17/2024 | Succinylcholine Chloride | Succinylcholine Chloride | Hikma | Dr Reddy's Labs | 218467 |
| 01/18/2024 | Acetaminophen / Butalbital / Caffeine | Acetaminophen / Butalbital / Caffeine | Actavis | Quagen | 214287 |
| 01/18/2024 | Phrenilin | Acetaminophen / Butalbital | Valeant | Quagen | 214291 |
| 01/18/2024 | Zebeta | Bisoprolol Fumarate | Teva | Harman Finochem | 217617 |
| 01/19/2024 | Dexilant | Dexlansoprazole | Takeda | Mylan | 205205 |
| 01/22/2024 | Parafon Forte DSC | Chlorzoxazone | Janssen | Havix | 210961 |
| 01/22/2024 | Lipitor | Atorvastatin Calcium | Upjohn | Laurus | 214513 |
| 01/22/2024 | Prolixin | Fluphenazine HCl | Apothecon | Torrent | 217094 |
| 01/22/2024 | Luvox | Fluvoxamine Maleate | ANI Pharms | Bionpharma | 217917 |
| 01/23/2024 | Mysoline | Primidone | Valeant | Carnegie | 218366 |
| 01/24/2024 | Gralise | Gabapentin | Almatica | Zydus | 203934 |
| 01/24/2024 | Vimpat | Lacosamide | UCB | Aurobindo | 209224 |
| 01/24/2024 | Lyrica | Pregabalin | Upjohn | Strides | 209883 |
| 01/25/2024 | Benicar | Olmesartan Medoxomil | Cosette | Breckenridge | 206227 |
| 01/25/2024 | Lipitor | Atorvastatin Calcium | Upjohn | Anbison Lab | 211886 |
| 01/25/2024 | Astagraf XL | Tacrolimus | Astellas | Chengdu | 215012 |
| 01/25/2024 | Hemabate | Carboprost Tromethamine | Pfizer | Ani Pharms | 215901 |
| 01/26/2024 | Diamox | Acetazolamide | Teva | Torrent | 213706 |
| 01/29/2024 | Levaquin | Levofloxacin | Jannsen | Knack | 216164 |
| 01/29/2024 | Absorbica | Isotretinoin | Sun Pharm | Aurobindo | 218194 |
| 01/30/2024 | Thiola EC | Tiopronin | Mission Pharmacal | Torrent | 216990 |
| 01/31/2024 | Multaq | Dronedarone HCl | Sanofi Aventis | Lupin | 205904 |
| 01/31/2024 | Tricor | Fenofibrate | AbbVie | Youngtech Pharms | 211407 |
| 01/31/2024 | Haldol | Haloperidol Lactate | Ortho McNeil | Rubicon | 218371 |
| 02/02/2024 | BromSite | Bromfenac Sodium | Sun Pharm | Lupin | 211239 |
| 02/02/2024 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | MSN | 218306 |
| 02/05/2024 | Lialda | Mesalamine | Takeda | Annora Pharma | 216334 |
| 02/06/2024 | Urocit-K | Potassium Citrate | Mission Pharmacal | Torrent | 213986 |
| 02/06/2024 | Cytomel | Liothyronine Sodium | King Pharms | Biocon Pharma | 218070 |
| 02/07/2024 | Kaletra | Lopinavir / Ritonavir | AbbVie | Mylan Labs | 079074 |
| 02/07/2024 | Cobicistat | Cobicistat | Gilead Sciences | Mylan Labs | 209986 |
| 02/07/2024 | Otezla | Apremilast | Amgen | Mankind Pharma | 211734 |
| 02/07/2024 | Dexamethasone | Dexamethasone | Hikma | Zydus | 216282 |
| 02/08/2024 | Trilipix | Choline Fenofibrate | AbbVie | Macleods Pharms | 207796 |
| 02/09/2024 | Dilaudid | Hydromorphone HCl | Fresenius Kabi | Hikma | 216899 |
| 02/09/2024 | Vasopressin | Vasopressin | Par | Gland Pharma | 216963 |
| 02/09/2024 | Emflaza | Deflazacort | PTC Therap | Aurobindo | 217123 |
| 02/09/2024 | Eohilia | Budesonide | Takeda | Takeda | N213976 |
| 02/12/2024 | Levetiracetam in Sodium Chloride | Levetiracetam | HQ Specialty Pharma | Hikma | 211356 |
| 02/12/2024 | Myrbetriq | Mirabegron | Apgdi | Alkem Labs | 215948 |
| 02/13/2024 | Ospemifene | Ospemifene | Duchesnay | Hetero Labs | 215574 |
| 02/13/2024 | Lipitor | Atorvastatin Calcium | Upjohn | Aurobindo | 217118 |
| 02/13/2024 | Advil Liqui-Gels | Ibuprofen | Haleon US | Patheon Softgels | 217236 |
| 02/13/2024 | Vimpat | Lacosamide | UCB | Hainan Poly | 217311 |
| 02/13/2024 | Aurlumyn | Iloprost | Eicos Sciences | Eicos Sciences | N217933 |
| 02/13/2024 | Legubeti | Acetylcysteine | Galephar | Galephar | N215040 |
| 02/14/2024 | Trileptal | Oxcarbazepine | Novartis | Medley Pharms | 217782 |
| 02/14/2024 | Protonix | Pantoprazole Sodium | Wyeth | Baxter Healthcare | N217512 |
| 02/15/2024 | Balcoltra | Ethinyl Estradiol / Levonorgestrel | Avion Pharms | Lupin | 217087 |
| 02/15/2024 | Imdur | Isosorbide Mononitrate | Schering Plough | Zydus | 218255 |
| 02/16/2024 | Norvir | Ritonavir | AbbVie | Mylan | 205024 |
| 02/16/2024 | Eliquis | Apixaban | Bristol Myers Squibb | Apotex | 210091 |
| 02/16/2024 | Rectiv | Nitroglycerin | AbbVie | Cosette | 216103 |
| 02/16/2024 | Lumify | Brimonidine Tartrate | Bausch and Lomb | Dr Reddy's Labs | 216361 |
| 02/16/2024 | Vascepa | Icosapent Ethyl | Amarin Pharms | Ascent Pharms | 216811 |
| 02/16/2024 | Tegretol | Carbamazepine | Novartis | Bionpharma | 218221 |
| 02/20/2024 | Vesicare | Solifenacin Succinate | Atellas | Macleods Pharms | 204374 |
| 02/20/2024 | Cellcept | Mycophenolate Mofetil | Roche Palo | Aurobindo | 217937 |
| 02/20/2024 | Xylocaine Viscous | Lidocaine HCl | Fresenius Kabi | Pai Holdings Pharm | 218138 |
| 02/22/2024 | Revlimid | Lenalidomide | Bristol Myers Squibb | Qilu | 217265 |
| 02/22/2024 | Oxtellar XR | Oxcarbazepine | Supurnus Pharms | Ajanta Pharma | 217659 |
| 02/23/2024 | Tenex | Guanfacine HCl | Promius Pharma | Xiromed | 218326 |
| 02/26/2024 | Gralise | Gabapentin | Almatica | Humanwell | 216252 |
| 02/26/2024 | Gralise | Gabapentin | Almatica | Annora Pharma | 218075 |
| 02/27/2024 | Levetiracetam in Sodium Chloride | Levetiracetam | HQ Specialty Pharma | B Braun Medical | 209705 |
| 02/27/2024 | Bystolic | Nebivolol HCl | Allergan | Apotex | 209741 |
| 02/27/2024 | Aptiom | Eslicarbazepine Acetate | Sumitomo | Torrent | 211227 |
| 02/27/2024 | Sodium Bicarbonate | Sodium Bicarbonate | Abbott Labs | Nivagen Pharms | 216042 |
| 02/27/2024 | Myfortic | Mycophenolic Sodium | Novartis | Aurobindo | 218603 |
| 02/28/2024 | Gilenya | Fingolimod HCl | Novartis | Aurobindo | 207983 |
| 02/28/2024 | Delatestryl | Testosterone Enanthate | Endo Pharms | Eugia Pharma | 212659 |
| 02/28/2024 | Taxotere | Docetaxel | Sanofi Aventis | Acic Pharms | 216677 |
| 02/29/2024 | Viread | Tenofovir Disoproxil Fumarate | Gilead Sciences | Mylan | 79071 |
| 02/29/2024 | Chantix | Varenicline Tartrate | PF Prism | Mylan | 202019 |
| 02/29/2024 | Mycelex | Clotrimazole | Bayer Healthcare | Thinq Pharm-Cro | 215641 |
| 02/29/2024 | Narcan | Naloxone HCl | Adapt Pharma | Mankind Pharma | 218404 |
| 03/01/2024 | Lastacaft | Alcaftadine | AbbVie | Gland Pharma | 209706 |
| 03/01/2024 | Ocuflox | Ofloxacin | Allergan | Amneal | 211524 |
| 03/01/2024 | Foscavir | Foscarnet Sodium | Clinigen Healthcare | Amneal | 216602 |
| 03/01/2024 | Abreva | Docosanol | Haleon US | Aurobindo | 217090 |
| 03/01/2024 | Trileptal | Oxcarbazepine | Novartis | Rising | 218278 |
| 03/04/2024 | Alphagan P | Brimonidine Tartrate | AbbVie | Sandoz | 203172 |
| 03/04/2024 | Neurontin | Gabapentin | Viatris | Strides Pharma | 211313 |
| 03/04/2024 | Cialis | Tadalafil | Eli Lilly & Co | Shandong | 216279 |
| 03/04/2024 | Clobetasol Propionate | Clobetasol Propionate | Formosa | Formosa | N218158 |
| 03/05/2024 | Trileptal | Oxcarbazepine | Novartis | Rubicon | 207717 |
| 03/05/2024 | Xeloda | Capecitabine | Cheplapharm | Hetero Labs | 210203 |
| 03/06/2024 | Chantix | Varenicline Tartrate | PF Prism | Avalanche Pharm | 217283 |
| 03/06/2024 | Hydrea | Hydroxyurea | Cheplapharm | Qilu | 218021 |
| 03/08/2024 | Tegretol-XR | Carbamazepine | Novartis | Apotex | 213159 |
| 03/08/2024 | Nimbex | Cisatracurium Besylate | AbbVie | Hainan Poly | 216538 |
| 03/12/2024 | Butalbital / Acetaminophen / Caffeine | Butalbital / Acetaminophen / Caffeine | Gilbert Labs | Quagen | 216376 |
| 03/13/2024 | Glumetza | Metformin HCl | Santarus | Macleods | 211163 |
| 03/13/2024 | Chlorpromazine HCl | Chlorpromazine HCl | West-Ward | Zydus | 217275 |
| 03/14/2024 | Olux-E | Clobetasol Propionate | Mylan | Taro | 208563 |
| 03/14/2024 | Vibramycin | Doxycycline Hyclate | Pfizer | Lupin | 217794 |
| 03/14/2024 | Vazculep | Phenylephrine HCl | Exela Pharma | Hainan Poly | 218412 |
| 03/14/2024 | Pepcid AC | Famotidine | Johnson & Johnson | Graviti Pharms | 218461 |
| 03/14/2024 | Sutent | Sunitinib Malate | CPPI CV | Eugia Pharma | 218615 |
| 03/14/2024 | Jevtana Kit | Cabazitaxel | Sanofi | Actavis / Teva | N207970 |
| 03/15/2024 | Sodium Acetate | Sodium Acetate | Hospira | Hikma | 216920 |
| 03/15/2024 | Entadfi | Finasteride / Tadalafil | Blue Water Biotech | Zydus | 218232 |
| 03/18/2024 | Abilify | Aripiprazole | Otsuka | Lupin | 205589 |
| 03/18/2024 | Trileptal | Oxcarbazepine | Novartis | Alkem Labs | 213183 |
| 03/18/2024 | Nasonex | Mometasone Furoate | Organon | Aurobindo | 215878 |
| 03/18/2024 | Duexis | Famotidine / Ibuprofen | Horizon Medicines | Torrent | 215925 |
| 03/18/2024 | Nuvessa | Metronidazole | Chemo Research | Encube | 216795 |
| 03/18/2024 | Lithium Citrate | Lithium Citrate | Hikma | Saptalis Pharms | 217183 |
| 03/19/2024 | Suprep Bowel Prep Kit | Magnesium Sulfate / Potassium Sulfate / Sodium Sulfate | Braintree Labs | Taro | 206431 |
| 03/19/2024 | Chantix | Varenicline Tartrate | PF Prism | Ajanta Pharma | 213019 |
| 03/19/2024 | Amikin | Amikacin Sulfate | Bristol Myers Squibb | Qilu | 218146 |
| 03/20/2024 | Diphenhydramine HCl | Diphenhydramine HCl | West-Ward | Gland Pharma | 218448 |
| 03/21/2024 | DDAVP | Desmopressin Acetate | Ferring | Aurobindo | 213095 |
| 03/21/2024 | Vemlidy | Tenofovir Alafenamide Fumarate | Gilead Sciences | Apotex | 213867 |
| 03/21/2024 | Carafate | Sucralfate | AbbVie | Abon Pharms | 216726 |
| 03/22/2024 | Duexis | Famotidine / Ibuprophen | Horizon Medicines | Par | 203658 |
| 03/22/2024 | Jadenu | Deferasirox | Novartis | Mylan | 211395 |
| 03/22/2024 | Ciprodex | Ciprofloxacin / Dexamethasone | Sandoz | Amneal | 216501 |
| 03/25/2024 | Monurol | Fosfomycin Tromethamine | Zambon | Amneal | 216600 |
| 03/25/2024 | Vimpat | Lacosamide | UCB | Dr Reddy's Labs | 217718 |
| 03/26/2024 | Acular | Ketorolac Tromethamine | AbbVie | Caplin | 218204 |
| 03/26/2024 | Advil Dual Action with Acetaminophen | Acetaminophen / Ibuprofen | Haleon US | Aurobindo | 218359 |
| 03/27/2024 | Vimpat | Lacosamide | UCB | Amneal | 204839 |
| 03/27/2024 | Aptiom | Eslicarbazepine Acetate | Sumitomo Pharma | Lupin | 211246 |
| 03/27/2024 | Hexadrol | Dexamethasone Sodium Phosphate | Aspen Global | Micro Labs | 217797 |
| 03/27/2024 | Sensorcaine | Bupivacaine HCl | Fresenius Kabi | Aspiro | 217821 |
| 03/29/2024 | Risvan | Risperidone | Rovi | Rovi | 214835 |
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