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ANDA Approvals
New Drug Applications and 505(b)(2) Applications
Second 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 # |
|---|---|---|---|---|---|
| 04/01/2024 | Corvert | Ibutilide Fumarate | Pfizer | Avet Lifesciences | 204146 |
| 04/02/2024 | Cleocin T | Clindamycin Phosphate | Pfizer | Alembic | 212466 |
| 04/02/2024 | Narcan | Naloxone HCl | Adapt Pharma | Fresenius Kabi | 213573 |
| 04/02/2024 | Brovana | Arformoterol Tartrate | Lupin | Pharmamax | 214901 |
| 04/02/2024 | Furosemide | Furosemide | American Regent | Saba Ilac Sanayive | 215856 |
| 04/02/2024 | Vimpat | Lacosamide | UCB | Medley Pharms | 218014 |
| 04/03/2024 | Hemabate | Carboprost Tromethamine | Pfizer | Micro Labs | 218013 |
| 04/03/2024 | Vfend | Voriconazole | PF Prism | Aspiro | 218533 |
| 04/04/2024 | Aubagio | Teriflunomide | Sanofi Aventis | Torrent | 209697 |
| 04/05/2024 | Mutamycin | Mitomycin | Bristol Labs | Fresenius Kabi | 211269 |
| 04/05/2024 | Prozac | Fluoxetine HCl | Eli Lilly | Strides Pharma | 212684 |
| 04/05/2024 | Ingrezza | Valbenazine Tosylate | Neurocrine | Lupin | 216064 |
| 04/05/2024 | Vimpat | Lacosamide | UCB | Hikma | 216806 |
| 04/05/2024 | Zioptan | Tafluprost | Thea Pharma | Ingenus Pharms | 218002 |
| 04/05/2024 | Halaven | Eribulin Mesylate | Esai | Gland Pharma | 218047 |
| 04/08/2024 | Children's Motrin | Ibuprofen | Johnson & Johnson | Aurobindo | 213506 |
| 04/08/2024 | Oracea | Doxycycline | Galderma | Lupin | 216631 |
| 04/08/2024 | Dextrose 5% | Dextrose | ICU Medical | American Regent | 217263 |
| 04/08/2024 | Neurontin | Gabapentin | Viatris | Laurus | 217965 |
| 04/08/2024 | Oracea | Doxycycline | Galderma | Dr. Reddy's Labs | 218034 |
| 04/09/2024 | Cefzil | Cefprozil | Corden Pharma | Alkem Labs Ltd. | 90857 |
| 04/09/2024 | Azilect | Rasagiline Mesylate | Teva | SKG Pharma | 218163 |
| 04/10/2024 | Cardene | Nicardipine HCl | Chiesi | SKG Pharma | 218202 |
| 04/10/2024 | Diprolene | Betamethasone Dipropionate | Organon | Aurobindo | 218289 |
| 04/11/2024 | Advil PM | Diphenhydramine Citrate / Ibuprofen | Haleon | PLD Acquisitions | 211404 |
| 04/11/2024 | Miacalcin | Calcitonin Salmon | Mylan | Dr. Reddy's Labs | 215715 |
| 04/11/2024 | Haldol | Haloperidol | Ortho McNeil | Mankind Pharma | 216918 |
| 04/12/2024 | Ocuflox | Ofloxacin | Allergan | Caplin | 217904 |
| 04/15/2024 | Vibra-Tabs | Doxycycline Hyclate | Pfizer | Nostrum Labs | 209560 |
| 04/15/2024 | Acticlate | Doxycycline Hyclate | Chartwell RX | Torrent | 214356 |
| 04/16/2024 | Tranexamic Acid | Tranexamic Acid | Exela Pharma | Nexus | 216877 |
| 04/16/2024 | Cetrotide | Cetrorelix Acetate | EMD Serono | Qilu | 217776 |
| 04/16/2024 | Tranexamic Acid | Tranexamic Acid | Exela Pharma | Gland Pharma | 218599 |
| 04/17/2024 | Cardene in 0.86% Sodium Chloride | Nicardipine HCl | Chiesi | InfoRLife | 203978 |
| 04/17/2024 | Zaroxolyn | Metolazone | i3Pharmaceuticals | Leading | 218606 |
| 04/18/2024 | Promacta Kit | Eltrombopag Olamine | Novartis | Annora Pharma | 216620 |
| 04/19/2024 | Haldol | Haloperidol | Ortho McNeil | Aurobindo | 218789 |
| 04/22/2024 | Estrogel | Estradiol | Ascend Theraps | Solaris Pharma | 216160 |
| 04/22/2024 | Rogaine | Minoxidil | Johnson & Johnson | Aurobindo | 218616 |
| 04/23/2024 | Isoptin | Verapamil HCl | MT Adams Technologies | Fresenius Kabi | 216471 |
| 04/23/2024 | Nasonex 24 Hour Allergy | Mometasone Furoate | Perrico Pharma | Apotex | 217438 |
| 04/23/2024 | Narcan | Naloxone HCl | Emergent | Amneal | 217992 |
| 04/23/2024 | Votrient | Pazopanib HCl | Novartis | Novugen | 218231 |
| 04/24/2024 | Cetrotide | Cetrorelix Acetate | EMD Serono | Livzon Grp. | 214540 |
| 04/24/2024 | Lotemax | Loteprednol Etabonate | Bausch | Lupin | 215719 |
| 04/24/2024 | Tricor | Fenofibrate | AbbVie | Yichang Humanwell | 218548 |
| 04/25/2024 | Renvela | Sevelamer Carbonate | Genzyme | Macleods | 207291 |
| 04/25/2024 | Xadago | Safinamide Mesylate | MDD US | Prinston | 215739 |
| 04/25/2024 | Emflaza | Deflazacort | PTC Therapeutics | Tris | 217813 |
| 04/25/2024 | Cetrotide | Cetrorelix Acetate | EMD Serono | Gland | 218150 |
| 04/25/2024 | Retin-A | Tretinoin | Valeant | Zydus | 218561 |
| 04/26/2024 | Advil Dual Action with Acetaminophen | Acetaminophen / Ibuprofen | Haleon | Glenmark | 218311 |
| 04/29/2024 | Mitigare | Colchicine | Hikma | Granules | 210757 |
| 04/29/2024 | Zetia | Ezetimibe | Organon | Macleods | 211159 |
| 04/29/2024 | Mitigare | Colchicine | Hikma | Aurobindo | 215463 |
| 04/29/2024 | Rydapt | Midostaurin | Novartis | Teva | 216076 |
| 04/29/2024 | Mitigare | Colchicine | Hikma | Annora Pharma | 217620 |
| 04/29/2024 | Isopto Atropine | Atropine Sulfate | Alcon Labs | Somerset Therapeutics | 217791 |
| 04/29/2024 | Retin-A | Tretinoin | Valeant | Alembic | 217804 |
| 04/29/2024 | Xylocaine 4% | Lidocaine HCl | Fresenius Kabi | The J Molner | 218411 |
| 04/30/2024 | Livalo | Pitavastatin Calcium | Kowa | Hetero Labs | 205977 |
| 04/30/2024 | Nexium 24 Hour | Esomeprazole Magnesium | AstraZeneca | Dr Reddy's Labs | 207198 |
| 04/30/2024 | Cupric Chloride | Cupric Chloride | Hospira | Somerset Therapeutics | 216113 |
| 04/30/2024 | Cupric Chloride | Cupric Chloride | Hospira | Stira | 217626 |
| 05/01/2024 | Lodine | Etodolac | Wyeth | Ipca Labs | 204729 |
| 05/01/2024 | Tamiflu | Oseltamivir Phosphate | Roche | Laurus | 218565 |
| 05/02/2024 | Sandostatin | Octreotide Acetate | Novartis | Shuangcheng | 217860 |
| 05/02/2024 | Prednisolone | Prednisolone | Watson | Zhejiang Xianju | 218083 |
| 05/03/2024 | Mozobil | Plerixafor | Genzyme | Gland Pharma | 206644 |
| 05/03/2024 | Travatan Z | Travoprost | Sandoz | Lupin | 207040 |
| 05/03/2024 | Velcade | Bortezomib | Takeda | Hetero Labs | 212204 |
| 05/03/2024 | Jadenu Sprinkle | Deferasirox | Novartis | Mylan | 213146 |
| 05/03/2024 | Accuneb | Albuterol Sulfate | Mylan | Lexenpharm | 215571 |
| 05/06/2024 | Xyzal | Levocetirizine Dihydrochloride | Sanofi | Ipca Labs | 204626 |
| 05/06/2024 | Trilafon | Perphenazine | Schering | Macleods | 212545 |
| 05/06/2024 | Transderm Scop | Scopolamine | Baxter Healthcare | Rhodes Pharms | 215329 |
| 05/06/2024 | Radicava | Edaravone | Mitsubishi Tanabe | Hikma | 215508 |
| 05/06/2024 | Radicava | Edaravone | Mitsubishi Tanabe | Dr. Reddy's Labs | 215917 |
| 05/06/2024 | Radicava | Edaravone | Mitsubishi Tanabe | Gland Pharma | 216199 |
| 05/06/2024 | Radicava | Edaravone | Mitsubishi Tanabe | Long Grove Pharms | 218354 |
| 05/07/2024 | Bentyl | Dicyclomine HCl | Allergan | Annora Pharma | 217566 |
| 05/08/2024 | Vasostrict | Vasopressin | Endo Operations | Dr. Reddy's Labs | 213988 |
| 05/08/2024 | Aczone | Dapsone | Almirall | Zydus | 214019 |
| 05/08/2024 | Astepro Allergy | Azelastine Hydrochloride | Bayer | Padagis | 216801 |
| 05/09/2024 | Renvela | Sevelamer Carbonate | Sanofi | Strides | 211915 |
| 05/09/2024 | Integrilin | Eptifibatide | Merck | Hong Kong | 213599 |
| 05/09/2024 | Dexamethasone | Dexamethasone | Hikma | Zydus | 216284 |
| 05/09/2024 | Zegerid OTC | Omeprazole / Sodium Bicarbonate | Riley Consumer | Dr. Reddy's Labs | 217784 |
| 05/09/2024 | Procomp | Prochlorperazine Maleate | Jubilant Cadista | Ajanta | 218515 |
| 05/10/2024 | Sustiva | Efavirenz | Merck | Macleods | 91579 |
| 05/10/2024 | Dacogen | Decitabine | Otsuka | Hetero Labs | 215355 |
| 05/10/2024 | Rydapt | Midostaurin | Novartis | Lupin | 216015 |
| 05/10/2024 | Calcium Gluconate | Calcium Gluconate | Fresenius Kabi | Amneal | 216611 |
| 05/10/2024 | Flonase Allergy Relief | Fluticasone Propionate | Haleon | Aurobindo | 217088 |
| 05/10/2024 | Vazculep | Phenylephrine HCl | Exela Pharma | Aspiro | 218110 |
| 05/10/2024 | Tamiflu | Oseltamivir Phosphate | Roche | Aurobindo | 218131 |
| 05/10/2024 | Cisplatin | Cisplatin | HQ Specialty | Qilu | 218868 |
| 05/13/2024 | Zanaflex | Tizanidine HCl | Legacy Pharma | Appco | 213365 |
| 05/13/2024 | Levophed | Norepinephrine Bitartrate | Hospira | Rising | 218758 |
| 05/14/2024 | Durezol | Difluprednate | Sandoz | Epic Pharma | 207284 |
| 05/14/2024 | Claritin-D 24 Hour | Loratadine / Pseudoephedrine Sulfate | Bayer Healthcare | Bionpharma | 218017 |
| 05/14/2024 | Diamox | Acetazolamide | Teva | Epic Pharma | 218023 |
| 05/15/2024 | Vimpat | Lacosamide | UCB | Chartwell RX | 215154 |
| 05/16/2024 | Vidaza | Azacitidine | Bristol-Myers Squibb | MSN Labs | 212580 |
| 05/16/2024 | Combigan | Brimonidine Tartrate / Timolol Maleate | AbbVie | Glenmark | 214987 |
| 05/16/2024 | Methotrexate Sodium | Methotrexate Sodium | Strides | Elite Labs | 216453 |
| 05/17/2024 | Exjade | Deferasirox | Novartis | Mylan | 206585 |
| 05/17/2024 | Lyrica | Pregabalin | Upjohn | Indoco | 208113 |
| 05/17/2024 | Descovy | Emtricitabine / Tenofovir Alafenamide Fumarate | Gilead Sciences | Apotex | 214053 |
| 05/17/2024 | Brovana | Arformoterol Tartrate | Lupin | CF Pharmtech | 216303 |
| 05/20/2024 | Seroquel | Quetiapine Fumarate | AstraZeneca | Ipca Labs | 205983 |
| 05/20/2024 | Trazodone HCl | Trazodone HCl | Pragma Pharms | Crossmedika | 211116 |
| 05/21/2024 | Restasis | Cyclosporine | AbbVie | Deva Holding | 209811 |
| 05/21/2024 | Proair HFA | Albuterol Sulfate | Teva | Armstrong Pharms | 212447 |
| 05/21/2024 | Carafate | Sucralfate | AbbVie | Strides | 216474 |
| 05/21/2024 | Somatuline Depot | Lanreotide Acetate | Ipsen Pharma | Invagen Pharms | 217193 |
| 05/21/2024 | Theo-Dur | Theophylline | Schering | Zydus | 218063 |
| 05/22/2024 | Irbesartan | Irbesartan | Sanofi Aventis | Ipca Labs | 211056 |
| 05/22/2024 | Pradaxa | Dabigatran Etexilate Mesylate | Boehringer Ingelheim | MSN Labs | 213879 |
| 05/22/2024 | Maxipime | Cefepime HCl | Hospira | Hikma | 214402 |
| 05/23/2024 | Alkeran | Melphalan HCl | Apotex | Hetero Labs | 215024 |
| 05/23/2024 | Phenylephrine HCl | Phenylephrine HCl | Paragon Bioteck | Caplin | 215183 |
| 05/23/2024 | Timoptic-XE | Timolol Maleate | Bausch | Amneal | 216343 |
| 5/24/2024 | Onyda XR | Clonidine HCl | Tris Pharma Inc. | Tris Pharma | N217645 |
| 05/24/2024 | Vimpat | Lacosamide | UCB | Macleods | 208466 |
| 05/24/2024 | Tarceva | Erlotinib HCl | OSI Pharms | Hetero Labs | 209267 |
| 05/28/2024 | Entresto | Sacubitril / Valsartan | Novartis | Crystal | 213605 |
| 05/28/2024 | Entresto | Sacubitril / Valsartan | Novartis | Laurus | 213676 |
| 05/28/2024 | Entresto | Sacubitril / Valsartan | Novartis | Alembic | 213682 |
| 05/28/2024 | Pepcid AC | Famotidine | Johnson & Johnson | Contract Pharmacal | 218003 |
| 05/29/2024 | Neurontin | Gabapentin | Viatris | Ipca Labs | 209855 |
| 05/29/2024 | Children's Astepro Allergy | Azelastine HCl | Bayer | Apotex | 216421 |
| 05/29/2024 | Mycamine | Micafungin Sodium | Astellas | Biocon Pharma | 216438 |
| 05/29/2024 | Myfortic | Mycophenolic Sodium | Novartis | Novugen | 216637 |
| 05/29/2024 | Halog | Halcinonide | Sun | Encube | 217671 |
| 06/03/2024 | Lipitor | Atorvastatin Calcium | Upjohn | Macleods | 208480 |
| 06/03/2024 | Brovana | Arformoterol Tartrate | Lupin | Dr. Reddy's Labs | 215032 |
| 06/03/2024 | Methotrexate Sodium | Methotrexate Sodium | Strides Pharma | Alembic | 217552 |
| 06/03/2024 | Xeljanz XR | Tofacitinib Citrate | Pfizer | Aurobindo | 218462 |
| 06/04/2024 | Fosomax | Alendronate Sodium | Organon | Ipca Labs | 206387 |
| 06/04/2024 | Sinemet CR | Carbidopa / Levodopa | Organon | Rubicon | 217482 |
| 06/04/2024 | Cozaar | Losartan Potassium | Organon | Apotex | 218551 |
| 06/05/2024 | Ibrance | Palbociclib | Pfizer | Synthon Pharms | 215570 |
| 06/05/2024 | Astepro Allergy | Azelastine HCl | Bayer | Amneal | 216576 |
| 06/06/2024 | Effexor XR | Venlafaxine HCl | Upjohn | Alembic | 217767 |
| 06/07/2024 | Prolixin | Fluphenazine HCl | Apothecon | Rising | 218283 |
| 06/07/2024 | Acetadote | Acetylcysteine | Cumberland Pharms | Somerset Therapeutics | 218397 |
| 06/10/2024 | Zinc Sulfate | Zinc Sulfate | American Regent | Apotex | 218059 |
| 06/11/2024 | Pomalyst | Pomalidomide | Bristol-Myers Squibb | Apotex | 210164 |
| 06/11/2024 | Valcyte | Valganciclovir HCl | Cheplapharm | GPP | 212876 |
| 06/11/2024 | Nexium 24 Hour | Esomeprazole Magnesium | AstraZeneca | Glenmark | 218092 |
| 06/11/2024 | Lysteda | Tranexamic Acid | Amring Pharms | Rubicon | 218320 |
| 06/12/2024 | Zovirax | Acyclovir | Bausch | Taro | 205470 |
| 06/12/2024 | Veletri | Epoprostenol Sodium | Actelion | Mylan | 213913 |
| 06/12/2024 | Qoliana | Brimonidine Tartrate | Sandoz | Upsher Smith Labs | 216772 |
| 06/12/2024 | Intuniv | Guanfacine HCl | Takeda | Wanbang Biopharms | 217638 |
| 06/12/2024 | EC-Naprosyn | Naproxen | Atnahs Pharma | Novitium Pharma | 218497 |
| 06/13/2024 | Topamax | Topiramate | Janssen | Alkem | 218482 |
| 06/14/2024 | Stendra | Avanafil | Metuchen Pharms | Hetero Labs | 209266 |
| 06/14/2024 | Firazyr | Icatibant Acetate | Takeda | Alembic | 213773 |
| 06/14/2024 | Pradaxa | Dabigatran Etexilate Mesylate | Boehringer Ingelheim | Alembic | 215233 |
| 06/14/2024 | Alimta | Pemetrexed Disodium | Eli Lilly | Hetero Labs | 215460 |
| 06/14/2024 | Cambia | Diclofenac Potassium | Assertio | Taro | 218011 |
| 06/17/2024 | Dotarem | Gadoterate Meglumine | Guerbet | Hainan Poly | 218073 |
| 06/18/2024 | Sanctura | Trospium Chloride | Allergan | Macleods | 206472 |
| 06/18/2024 | Lidocaine | Lidocaine | Fougera | Aurobindo | 217117 |
| 06/20/2024 | Diprivan | Propofol | Fresenius Kabi | Aspiro | 217013 |
| 06/21/2024 | Vibramycin | Doxycycline Hyclate | Pfizer | Hainan Poly | 217685 |
| 06/21/2024 | Sodium Phosphates in Plastic Container | Sodium Phosphate, Dibasic, Heptahydrate / Sodium Phosphate, Monobasic, Anhydrous | Hospira | American Regent | 218314 |
| 06/24/2024 | Suprep Bowel Prep Kit | Magnesium Sulfate / Potassium Sulfate / Sodium Sulfate | Braintree Labs | Bionpharma | 204135 |
| 06/24/2024 | Sodium Chloride 0.9% in Plastic Container | Sodium Chloride | B Braun | Fresenius Kabi | 213688 |
| 06/25/2024 | Qsymia | Phentermine HCl / Topiramate | Vivus | Actavis | 204982 |
| 06/25/2024 | Busulfex | Busulfan | Otsuka | Eugia Pharma | 215102 |
| 06/25/2024 | Acyclovir Sodium | Acyclovir Sodium | Fresenius Kabi | DDReg Pharma | 215404 |
| 06/25/2024 | Dostinex | Cabergoline | Pfizer | SKG Pharma | 218618 |
| 6/25/2024 | Tepylute | Thiotepa | Shorla | Shorla | NDA216984 |
| 06/26/2024 | Risperdal | Risperidone | Janssen | Ipca Labs | 205104 |
| 06/26/2024 | Tecfidera | Dimethyl Fumarate | Biogen | Macleods | 210377 |
| 06/26/2024 | Perforomist | Formoterol Fumarate | Mylan | Micro Labs | 218304 |
| 06/26/2024 | Invega | Paliperidone | Janssen | Ajanta Pharma | 218514 |
| 06/27/2024 | Oracea | Doxycycline | Galderma Labs | Alembic | 217674 |
| 06/28/2024 | Moviprep | Ascorbic Acid / Polyethylene Glycol 3350 / Potassium Chloride / Sodium Ascorbate / Sodium Chloride / Sodium Sulfate | Salix | Taro | 207498 |
| 06/28/2024 | Azilect | Rasagiline Mesylate | Teva | Macleods | 208866 |
| 06/28/2024 | Ultiva | Remifentanil HCl | Mylan | Nivagen Pharms | 215635 |
| 06/28/2024 | Rydapt | Midostaurin | Novartis | Dr. Reddy's Labs | 215921 |
| 06/28/2024 | Halaven | Eribulin Mesylate | Esai | Jiangxi Qingfeng | 218281 |
| 6/28/2024 | Alimtra | Pemetrexed | Eli Lilly | Apotex | N210661 |
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