New Drug Applications and 505(B)(2) Applications
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 # |
| 10/01/2024 | Lamictal XR | lamotrigine | GlaxoSmithKline | Alembic | 211821 |
| 10/01/2024 | Chantix | varenicline tartrate | Esai | Dr. Reddy's Labs | 215931 |
| 10/01/2024 | Halaven | eribulin mesylate | Esai | Baxter Healthcare | 217250 |
| 10/01/2024 | Bystolic | nebivolol HCl | Allergan | MSN | 217397 |
| 10/02/2024 | Vesicare | solifenacin succinate | Astellas | Jubilant | 205484 |
| 10/02/2024 | Lastacaft | alcaftadine | AbbVie | Alembic | 209290 |
| 10/03/2024 | Savella | milnacipran HCl | AbbVie | Hetero Labs | 205147 |
| 10/03/2024 | Brevital Sodium | methohexital sodium | Endo Operations | Steriscience Specialties | 215488 |
| 10/03/2024 | Isuprel | isoproterenol HCl | Bausch Health | Gland | 217648 |
| 10/03/2024 | Diuril | chlorothiazide sodium | Rising Pharma | Gland | 218630 |
| 10/03/2024 | Zyrtec Allergy | cetirizine HCl | Kenvue Brands | Indoco | 218895 |
| 10/04/2024 | Mestinon | pyridostigmine bromide | Bausch | Amneal | N217604 |
| 10/04/2024 | Chlorpromazine HCl | chlorpromazine HCl | Hikma | Gland | 216911 |
| 10/07/2024 | Cuvposa | glycopyrrolate | Merz | Saptalis Pharms | 216297 |
| 10/08/2024 | Abraxane | paclitaxel | Bristol-Myers Squibb | Hengrui Pharma | 212700 |
| 10/08/2024 | Invega | paliperidone | Jannsen | Zydus | 217445 |
| 10/09/2024 | Vimpat | lacosamide | UCB | Somerset Therapeutics | 214960 |
| 10/10/2024 | Zyvox | linezolid | Pfizer | Macleods | 210378 |
| 10/10/2024 | Betimol | timolol | Thea Pharma | Somerset | 216654 |
| 10/10/2024 | Topamax | topiramate | Jannsen | Senores Pharms | 218642 |
| 10/11/2024 | Exforge | amlodipine besylate / valsartan | Novartis | Macleods | 207292 |
| 10/11/2024 | Akovaz | ephedrine sulfate | Exela Pharma | Hikma | 217721 |
| 10/15/2024 | Vidaza | azacitidine | Bristol-Myers Squibb | Hetero Labs | 215765 |
| 10/15/2024 | Floxin Otic | ofloxacin | Daiichi | Somerset Therapeutics | 216328 |
| 10/15/2024 | Micardis | telmisartan | Boehringer Ingelheim | Mankind Pharma | 218157 |
| 10/15/2024 | Nitrostat | nitroglycerin | Viatris | Viwit Pharm | 218583 |
| 10/15/2024 | Metrogel | metronidazole | Galderma Labs | Aurobindo | 218941 |
| 10/16/2024 | Entresto | sacubitril / valsartan | Novartis | Macleods | 213728 |
| 10/16/2024 | Zinc Chloride in Plastic Container | zinc chloride | Hospira | Somerset | 216152 |
| 10/16/2024 | Stromectol | ivermectin | Merck Sharp Dohme | Senores Pharms | 218324 |
| 10/16/2024 | Pepcid | famotidine | Salix | Epic Pharma | 218344 |
| 10/16/2024 | Florinef | fludrocortisone acetate | Casper Pharma | Zydus | 219251 |
| 10/17/2024 | Lupron | leuprolide acetate | AbbVie | UBI | 217957 |
| 10/17/2024 | Wellbutrin SR | bupropion HCl | GlaxoSmithKline | Granules | 218385 |
| 10/17/2024 | Luvox CR | fluvoxamine maleate | Jazz Pharms | Ajanta | 219055 |
| 10/18/2024 | Fortamet | metformin HCl | Andrx Labs | Aurobindo | 209694 |
| 10/18/2024 | Suprep Bowel Prep Kit | magnesium sulfate / potassium sulfate / sodium sulfate | Braintree Labs | Annora Pharma | 212903 |
| 10/21/2024 | Xopenex | levalbuterol HCl | Hikma | Mankind | 218770 |
| 10/22/2024 | Cellcept | mycophenolate mofetil | Roche Palo | Hetero Labs | 207022 |
| 10/22/2024 | Tegretol-XR | carbamazepine | Novartis | Osmotica Pharm | 215664 |
| 10/22/2024 | Perforomist | formoterol fumarate | Mylan | Lexenpharm | 216426 |
| 10/23/2024 | Nexium | esomeprazole magnesium | AstraZeneca | Macleods | 208511 |
| 10/23/2024 | Estrogel | estradiol | Ascend Therapeutics | Novitium Pharma | 217882 |
| 10/24/2024 | Minocin | minocycline HCl | Rempex | Nexus Pharms | 214934 |
| 10/24/2024 | Renvela | sevelamer carbonate | Sanofi | Shandong Xinhua | 215998 |
| 10/28/2024 | Vibramycin | doxycycline hyclate | Pfizer | Kindos | 218053 |
| 10/28/2024 | Furadantin | nitrofurantoin | Casper Pharma | Biocon Pharma | 218346 |
| 10/28/2024 | Klor-Con | potassium chloride | Upsher Smith Labs | TWi | 218979 |
| 10/29/2024 | Alkeran | melphalan HCl | Apotex | Avet Lifesciences | 206523 |
| 10/29/2024 | Brilinta | ticagrelor | Astrazeneca | Dr. Reddy's Labs | 208541 |
| 10/29/2024 | Cyclophosphamide | cyclophosphamide | Dr. Reddy's Labs | Nexus | 216783 |
| 10/29/2024 | Thiamine HCl | thiamine HCl | Fresenius Kabi | Steriscience Specialties | 217181 |
| 10/29/2024 | Chantix | varenicline tartrate | PF Prism | Indoco | 219106 |
| 10/30/2024 | Tamiflu | oseltamivir phosphate | Roche | Nanjing Daoqun | 217133 |
| 10/31/2024 | Benicar | olmesartan medoxomil | Cosette | Hetero Labs | 205499 |
| 10/31/2024 | Questran Light | cholestyramine | Bristol Myers Squibb | Macleods | 209109 |
| 10/31/2024 | Nicardipine HCl | nicardipine HCl | Hikma | Amneal | 215406 |
| 10/31/2024 | Radicava | edaravone | Mitsubishi Tanabe | Xgen Pharms | 217565 |
| 10/31/2024 | Eprontia | topiramate | Azurity | Alkem Labs | 217795 |
| 10/31/2024 | Invanz | ertapenem sodium | Merck Sharp Dohme | Qilu Antibiotics | 218067 |
| 11/01/2024 | Bentyl | dicyclomine HCl | AbbVie | Somerset Therapeutics | 214332 |
| 11/04/2024 | Prevacid | lansoprazole | Takeda | Macleods | 208671 |
| 11/05/2024 | Exjade | deferasirox | Novartis | Torrent | 209426 |
| 11/05/2024 | Qudexy XR | topiramate | Upsher Smith Labs | Xiamen | 215638 |
| 11/05/2024 | Emflaza | deflazacort | PTC Therapeutics | Upsher Smith Labs | 216720 |
| 11/05/2024 | Cetraxal | ciprofloxacin HCl | Key Therapeutics | IdentiRx | 217887 |
| 11/06/2024 | Crestor | rosuvastatin calcium | IPR Pharms | Macleods | 207296 |
| 11/06/2024 | Zaroxolyn | metolazone | i3 Pharmaceuticals | Micro Labs | 217563 |
| 11/06/2024 | Thiamine HCl | thiamine HCl | Fresenius Kabi | Aspiro | 218471 |
| 11/07/2024 | Cellcept | mycophenolate mofetil | Roche Palo | Wuxi | 214079 |
| 11/07/2024 | Adderall XR 5 | amphetamine aspartate / amphetamine sulfate / dextroamphetamine saccharate / dextroamphetamine sulfate | Takeda | Lupin | 214777 |
| 11/07/2024 | Tagamet | cimetidine | GlaxoSmithKline | Bionpharma | 218220 |
| 11/08/2024 | Benicar | olmesartan medoxomil | Cosette | Cadila Pharms | 210682 |
| 11/08/2024 | Children's Motrin | ibuprofen | Kenvue Brands | Pai Holdings Pharm | 214789 |
| 11/08/2024 | Corlanor | ivabradine HCl | Amgen | Alembic | 215238 |
| 11/08/2024 | Clomid | clomiphene citrate | Sanofi Aventis | Appco | 216739 |
| 11/08/2024 | Cardizem CD | diltiazem HCl | Baush | Alembic | 216968 |
| 11/12/2024 | Lyrica | pregabalin | Upjohn | Macleods | 205924 |
| 11/12/2024 | Chlorthalidone | chlorthalidone | Mylan | Ipca Labs | 209162 |
| 11/12/2024 | Clomid | clomiphene citrate | Sanofi Aventis | Rubicon | 216545 |
| 11/12/2024 | Tagamet | cimetidine | GlaxoSmithKline | Aurobindo | 218997 |
| 11/13/2024 | Tricor | fenofibrate | AbbVie | Macleods | 210248 |
| 11/13/2024 | Carafate | sucralfate | AbbVie | Cosette | 217126 |
| 11/14/2024 | Vigamox | moxifloxacin HCl | Harrow Eye | Somerset Therapeutics | 209698 |
| 11/14/2024 | Vimpat | lacosamide | UCB | Acella | 218464 |
| 11/15/2024 | Vibisone | cyanocobalamin | Fresenius Kabi | Nanjing King-Friend | 214316 |
| 11/15/2024 | Vyvanse | lisdexamfetamine dimesylate | Takeda | Elite Labs | 218604 |
| 11/15/2024 | Bentyl | dicyclomine HCl | Allergan | Rising | 218952 |
| 11/15/2024 | Atrovent | ipratropium bromide | Boehringer Ingelheim | Rubicon | 219221 |
| 11/18/2024 | Ativan | lorazepam | Hikma | Fresenius Kabi | 217598 |
| 11/18/2024 | Brovana | arformoterol tartrate | Lupin | Lexenpharm | 218156 |
| 11/18/2024 | Chlorpromazine HCl | chlorpromazine HCl | Hikma | Aspiro | 218272 |
| 11/18/2024 | Chromic Chloride in plastic container | chromic chloride | Hospira | Rk Pharma | 218538 |
| 11/19/2024 | Byetta | exenatide synthetic | AstraZeneca | Amneal | 206697 |
| 11/19/2024 | Indocin | indomethacin | Zyla Life Sciences | Hikma | 215899 |
| 11/19/2024 | Erythrocin | erythromycin lactobionate | Hospira | Gland Pharma | 216761 |
| 11/19/2024 | Intuniv | guanfacine HCl | Takeda | Unichem | 219033 |
| 11/20/2024 | Epinephrine | epinephrine | BPI Labs | Fresenius Kabi | 213708 |
| 11/20/2024 | Vascepa | icosapent ethyl | Amarin Pharms | Qilu | 218899 |
| 11/21/2024 | Questran Light | cholestyramine | Bristol Myers Squibb | Macleods | 207294 |
| 11/21/2024 | ProvayBlue | methylene blue | Provepharm | Nexus | 217561 |
| 11/21/2024 | Claratin | loratadine | Bayer Healthcare | Marksans Pharma | 219223 |
| 11/22/2024 | Oxtellar XR | oxcarbazepine | Supernus | Riconpharma | 215796 |
| 11/22/2024 | ProvayBlue | methylene blue | Provepharm | Steriscience | 216955 |
| 11/22/2024 | Nasonex 24 Hr. Allergy | mometasone furoate | Perrigo | Aurobindo | 217498 |
| 11/25/2024 | Otezla | apremilast | Amgen | Macleods | 211788 |
| 11/25/2024 | Cortef | hydrocortisone | Pharmacia and Upjohn | Hibrow Healthcare | 217160 |
| 11/26/2024 | Seroquel XR | quetiapine fumarate | AstraZeneca | Graviti Pharms | 211144 |
| 11/26/2024 | Rogaine (for women) | minoxidil | Kenvue Brands | Taro | 218175 |
| 11/26/2024 | Xalatan | latanoprost | Upjohn | Gland | 218257 |
| 11/27/2024 | Zocor | simvastatin | Organon | Yiling | 211394 |
| 11/27/2024 | Potassium Acetate | potassium acetate | Hospira | Fresenius Kabi | 217515 |
| 11/27/2024 | Calcium Chloride 10% in plastic container | calcium chloride | Hospira | Extrovis | 219342 |
| 11/29/2024 | Rectiv | nitroglycerin | AbbVie | Acrux | 212222 |
| 11/29/2024 | Aropine Sulfate | atropine sulfate | Fresenius Kabi | Somerset Therapeutics | 215005 |
| 11/29/2024 | Levothyroxine Sodium | levothyroxine sodium | Fresenius Kabi | Xiromed | 217495 |
| 12/02/2024 | Clobex | clobetasol propionate | Galderma Labs | Macleods | 214345 |
| 12/03/2024 | Abilify Maintena | aripiprazole | Otsuka Pharm | Mylan | 216608 |
| 12/03/2024 | Tamiflu | oseltamivir phosphate | Roche | Cediprof | 217451 |
| 12/03/2024 | Colestid | colestipol HCl | Pfizer | Riconpharma | 217462 |
| 12/03/2024 | Cyclophosphamide | cyclophosphamide | Hikma | Nextsource | 218282 |
| 12/03/2024 | Qudexy XR | topiramate | Upsher Smith Labs | Amta | 218695 |
| 12/04/2024 | Vibramycin | doxycycline hyclate | Pfizer | Amneal | 217487 |
| 12/04/2024 | Votrient | pazopanib HCl | Novartis | Eugia Pharma | 219034 |
| 12/05/2024 | Miacalcin | calcitonin salmon | Mylan | Fresenius Kabi | 212675 |
| 12/06/2024 | Latuda | lurasidone HCl | Sunovion | Jubilant | 210388 |
| 12/09/2024 | Tham | tromethamine | Hospira | B. Braun Medical | 211558 |
| 12/09/2024 | Adreview | iobenguane sulfate i-123 | GE Healthcare | BWXT Medical | 213637 |
| 12/09/2024 | Chantix | varenicline tartrate | PF Prism | Macleods | 215048 |
| 12/09/2024 | Kenalog-40 | triamcinolone acetonide | Apothecon | Hikma | 215254 |
| 12/10/2024 | Targretin | bexarotene | Valeant | Cipla | 210352 |
| 12/10/2024 | Vytorin | ezetimibe / simvastatin | Organon | Sciegen | 211663 |
| 12/10/2024 | Cerdelga | eliglustat tartrate | Genzyme | Cipla | 212369 |
| 12/10/2024 | Chlorpromazine HCl | chlorpromazine HCl | Hikma | Thinq Pharm-Cro | 216724 |
| 12/10/2024 | Vitamin K1 | phytonadione | Hospira | Gland Pharma | 217386 |
| 12/12/2024 | Glucagon | glucagon | Eli Lilly | Mylan | 204468 |
| 12/12/2024 | Fazaclo ODT | clozapine | Jazz | Aurobindo | 212923 |
| 12/13/2024 | Descovy | emtricitabine / tenofovir alafenamide fumarate | Gilead Sciences | Lupin | 213926 |
| 12/13/2024 | Alrex | loteprednol etabonate | Bausch and Lomb | Amneal | 216345 |
| 12/13/2024 | Chronulac | lactulose | Sanofi | Taro | 218858 |
| 12/13/2024 | Durezol | difluprednate | Sandoz | Caplin | 219441 |
| 12/16/2024 | Otezla | apremilast | Amgen | MSN | 211887 |
| 12/16/2024 | Rectiv | nitroglycerin | AbbVie | Encube | 216452 |
| 12/16/2024 | Methadone HCl | methadone HCl | Mylan | Breckenridge | 218252 |
| 12/16/2024 | Xeljanz XR | tofacitinib citrate | Pfizer | Dexcel | 218668 |
| 12/16/2024 | Vyvanse | lisdexamfetamine dimesylate | Takeda | Granules | 219258 |
| 12/17/2024 | Suprax | cefixime | Lederle | FDC | 206358 |
| 12/17/2024 | Eliquis | apixaban | Bristol Myers Squibb | Torrent | 210156 |
| 12/17/2024 | ProvayBlue | methylene blue | Provepharm | RK Pharma | 216959 |
| 12/17/2024 | Calcium Chloride 10% in plastic container | calcium chloride | Hospira | Somerset | 218133 |
| 12/17/2024 | Vyvanse | lisdexamfetamine dimesylate | Takeda | SpecGx | 218850 |
| 12/17/2024 | Emla | lidocaine / prilocaine | AstraZeneca | Zydus | 219120 |
| 12/18/2024 | Esbriet | pirfenidone | Genentech | Macleods | 212748 |
| 12/18/2024 | Pataday | olopatadine HCl | Alcon Labs | Somerset | 215006 |
| 12/18/2024 | Phenylephrine HCl | phenylephrine HCl | Paragon | Gland Pharma | 218129 |
| 12/18/2024 | Arixtra | fondaparinux sodium | Mylan | Brightgene | 218312 |
| 12/19/2024 | Isentress | raltegravir potassium | Merck Sharp Dohme | Hetero Labs | 203540 |
| 12/19/2024 | Pradaxa | dabigatran etexilate mesylate | Boehringer Ingelheim | Breckenridge | 207922 |
| 12/19/2024 | Mephyton | phytonadione | Bausch | Hikma | 212112 |
| 12/19/2024 | Epzicom | abacavir sulfate / lamivudine | ViiV Healthcare | Macleods | 212663 |
| 12/19/2024 | Cyclophosphamide | cyclophosphamide | Baxter Healthcare | Epic Pharma | 218644 |
| 12/19/2024 | Depakote | divalproex sodium | AbbVie | Alembic | 218793 |
| 12/20/2024 | Viagra | sildenafil citrate | Viatris | Jubilant Generics | 201156 |
| 12/20/2024 | Tetracaine HCl | tetracaine HCl | Bausch and Lomb | Somerset Therapeutics | 217227 |
| 12/20/2024 | Vascepa | icosapent ethyl | Amarin Pharms | Spriaso | 218994 |
| 12/23/2024 | Victoza | liraglutide | Novo Nordisk | Hikma | 215503 |
| 12/23/2024 | Baraclude | entecavir | Bristol Myers Squibb | Conba USA | 216857 |
| 12/23/2024 | Radicava | edaravone | Mitsubishi Tanabe | Sandoz | 216902 |
| 12/23/2024 | Noxafil | posaconazole | Merck Sharp Dohme | Aspiro | 219057 |
| 12/26/2024 | Austedo | deutetrabenazine | Teva | Aurobindo | 215971 |
| 12/26/2024 | Motegrity | prucalopride succinate | Takeda | Novitium | 218492 |
| 12/26/2024 | Cytoxan | cyclophosphamide | Baxter Healthcare | Hainan Poly | 218632 |
| 12/27/2024 | Bumex | bumetanide | Validus Pharms | Rubicon | 213942 |
| 12/30/2024 | Combigan | brimonidine tartrate / timolol maleate | AbbVie | Amneal | 217288 |
| 12/31/2024 | Tham | tromethamine | Hospira | Milla Pharms | 213116 |
| 12/31/2024 | Cuvposa | glycopyrrolate | Merz | Aurobindo | 214847 |
| 12/31/2024 | Xadago | safinamide mesylate | MDD US | MSN | 215978 |
| 12/31/2024 | Metrogel | metronidazole | Bausch | Saptalis | 216750 |
| 12/31/2024 | Diazepam | diazepam | Beloteca. | Long Grove | 217178 |
| 12/31/2024 | Imitrex | sumatriptan succinate | GlaxoSmithKline | VKT Pharma | 219036 |
