ANDA Approvals

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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 #
01/02/2025 Myrbetriq Mirabegron APGDI (Astellas) Apotex 209434
01/02/2025 Amitiza Lubiprostone Sucampo Pharma Ascent Pharms 218640
01/03/2025 Phytonadione Phytonadione Int'l Medication Cipla 214966
01/03/2025 Clolar Clofarabine Genzyme ScinoPharm Taiwan 216233
01/06/2025 Tecfidera Dimethyl Fumarate Biogen Torrent 210390
01/07/2025 Exforge HCT Amlodipine Besylate / Hydrochlorothiazide / Valsartan Novartis Macleods 207299
01/07/2025 D.H.E. 45 Dihydroergotamine Mesylate Bausch Health Baxter Healthcare 216747
01/07/2025 Nexium Esomeprazole Magnesium AstraZeneca Cipla 217714
01/07/2025 Relafen Nabumetone SmithKline Beecham Novitium Pharma 219118
01/08/2025 Entresto Sacubitril / Valsartan Novartis Lupin 213808
01/08/2025 Lonsurf Tipiracil Hydrochloride / Trifluridine Taiho Oncology MSN 214024
01/08/2025 Nexium IV Esomeprazole Sodium AstraZeneca Yangtze 214046
01/08/2025 Lopressor HCT Hydrochlorothiazide / Metoprolol Tartrate Validus Pharms Senores Pharms 215789
01/10/2025 Afinitor Disperz Everolimus Novartis Pharm Amneal 218863
01/13/2025 Latuda Lurasidone HCl Sunovion Pharms Torrent 208055
01/13/2025 Stivarga Regorafenib Bayer Healthcare Actavis 209728
01/13/2025 Tegretol-XR Carbamazepine Novartis Torrent 212524
01/13/2025 Entresto Sacubitril / Valsartan Novartis Dr. Reddy's 213627
01/13/2025 Rexulti Brexpiprazole Otsuka Alembic 213683
01/13/2025 Retin-A Tretinoin Bausch Aurobindo 218246
01/13/2025 THEO-DUR Theophylline Schering Plough Ajanta 218401
01/13/2025 Mesnex Mesna Baxter Healthcare Riconpharma 218871
01/14/2025 Furadantin Nitrofurantoin Casper Pharma Appco 208909
01/14/2025 Tegretol-XR Carbamazepine Novartis Alkem Labs 217277
01/14/2025 Sinemet Carbidopa / Levodopa Organon Ascent 218939
01/14/2025 Atrovent Ipratropium Bromide Boehringer Ingelheim Rubicon 219222
01/15/2025 Micardis Telmisartan Boehringer Ingelheim Macleods 203986
01/15/2025 Pristiq Desvenlafaxine Succinate PF Prism Macleods 211427
01/16/2025 Emerphed Ephedrine Sulfate Nexus Gland Pharma 218211
01/16/2025 Tegretol-XR Carbamazepine Novartis Yichang Humanwell 219072
01/16/2025 Protonix Pantoprazole Sodium Wyeth Pharms Graviti Pharms 219087
01/16/2025 Levetiracetam Levetiracetam HQ Specialty Caplin 219562
01/17/2025 Promacta Eltrombopag Olamine Novartis Hetero Labs 206788
01/17/2025 Advil Dual Action with Acetaminophen Acetaminophen / Ibuprofen Haleon Strides Pharma 217241
01/21/2025 Prezista Darunavir Janssen Annora Pharma 216168
01/21/2025 Steglatro Ertugliflozin Merck Sharp & Dohme Hikma 216842
01/21/2025 Edarbyclor Azilsartan Kamedoxomil / Chlorthalidone Azurity Alkem 217490
01/22/2025 Nymalize Nimodipine Azurity Alkem 213409
01/22/2025 Cambia Diclofenac Potassium Assertio Torrent 215891
01/22/2025 Stromectol Ivermectin Merck Sharp & Dohme Rubicon 215922
01/23/2025 Provayblue Methylene Blue Provepharm Meitheal 217380
01/23/2025 Aldactone Spironolactone Pfizer Graviti Pharms 219494
01/24/2025 Potassium Phosphates Potassium Phosphate, Dibasic / Potassium Phosphate, Monobasic Fresenius Kabi Cipla 217892
01/27/2025 Vytorin Ezetimibe / Simvastatin Organon Torrent 209461
01/27/2025 Nexavar Sorafenib Tosylate Bayer Healthcare Apotex 212228
01/27/2025 Astepro Azelastine HCl Bayer Healthcare Aurobindo Pharma 216561
01/27/2025 Oracea Doxycycline Galderma Labs Prinston 217098
01/27/2025 Atrovent Ipratropium Bromide Boehringer Ingelheim Lupin 217886
01/27/2025 Oxaliplatin Oxaliplatin Teva Hetero Labs 217925
01/27/2025 Vigamox Moxifloxacin HCl Harrow Eye Mankind 217988
01/28/2025 Pradaxa Dabigatran Etexilate Mesylate Boehringer Ingelheim Dr. Reddy's 208048
01/28/2025 Bystolic Nebivolol HCl Allergan Macleods 212661
01/28/2025 Dyazide Hydrochlorothiazide / Triamterene GlaxoSmithKline Macleods 214611
01/28/2025 Afinitor Disperz Everolimus Novartis Natco 217640
01/28/2025 Lyrica CR Pregabalin Upjohn HQ Pharma 217857
01/28/2025 Venlafaxine HCl Venlafaxine HCl Osmotica Pharm Torrent 218180
01/29/2025 Lotemax Loteprednol Etabonate Bausch and Lomb Padagis 215204
01/29/2025 Vyvanse Lisdexamfetamine Dimesylate Takeda Granules 218987
01/30/2025 Perforomist  Formoterol Fumarate Viatris Specialty Dr. Reddy's 215907
01/30/2025 Buprenex Buprenorphine HCl Indivior Somerset Therapeutics 219302
01/31/2025 Revlimid Lenalidomide Bristol-Myers Squibb Amneal 216213
01/31/2025 Levophed Norepinephrine Bitartrate Hospira Aspiro 219163
02/03/2025 Pradaxa Dabigatran Etexilate Mesylate Boehringer Ingelheim Mylan 208067
02/03/2025 Alinia Nitazoxanide Romark Labs Zenara 214844
02/03/2025 Brovana Arformoterol Tartrate Lupin Aucta 218380
02/03/2025 Renagel Sevelamer HCl Genzyme Navinta 218966
02/04/2025 Renexa Ranolazine Menarini Torrent 210407
02/04/2025 Pronestyl Procainamide HCl Apothecon Caplin 218674
02/05/2025 Tracleer Bosentan Actelion Natco Pharma 213154
02/05/2025 Tapazole Methimazole King Pharms Square Pharms 218830
02/06/2025 Adrucil Fluorouracil Pharmacia and Upjohn  Kindos 215699
02/06/2025 Epinephrine Epinephrine BPI Labs Gland Pharma 219239
02/07/2025 Venlafaxine HCl Venlafaxine HCl Osmotica Pharm Abon Pharms 217841
02/07/2025 Atrovent Ipratropium Bromide Boehringer Ingelheim Lupin 217912
02/10/2025 Rapaflo Silodosin AbbVie Torrent 210396
02/10/2025 Selenious Acid Selenious Acid American Regent Fresenius Kabi 218779
02/11/2025 Benztropine Mesylate Benztropine Mesylate Lannett Quagen 212694
02/11/2025 Trusopt Dorzolamide HCl Merck Sharp & Dohme Somerset Therapeutics 215004
02/11/2025 Succinylcholine Chloride Succinylcholine Chloride Hikma Fresenius Kabi 217884
02/11/2025 Durezol Difluprednate Sandoz Upsher Smith 218191
02/11/2025 Perforomist  Formoterol Fumarate Viatris Specialty Deva Holding 218308
02/11/2025 Prohance Gadoteridol Bracco Hainan Poly 218749
02/12/2025 Efudex Fluorouracil Entrovis Encube 216942
02/12/2025 Prograf Tacrolimus Astellas Nexus 217108
02/12/2025 Mucomyst Acetylcysteine Apothecon Somerset Therapeutics 219194
02/14/2025 Azor Amlodipine Besylate / Olmesartan Medoxomil Cosette Hetero Labs 209591
02/14/2025 Eliquis Apixaban Bristol-Myers Squibb Impax 209810
02/14/2025 Sutent Sunitinib Malate CPPI CV MSN 214824
02/14/2025 Biorphen Phenylephrine HCl Dr. Reddy's Somerset Therapeutics 215617
02/18/2025 Asacol HD Mesalamine AbbVie Amneal 215067
02/18/2025 Cosopt PF Dorzolamide HCl / Timolol Maleate Thea Pharma IdentiRX 216308
02/19/2025 Tasigna Nilotinib D-Tartrate Novartis Cipla N218922 
02/19/2025 Invega Paliperidone Janssen Dr. Reddy's 205559
02/20/2025 Duexis Famotidine / Ibuprofen Horizen Medicines  Zydus 218684
02/20/2025 Selenious Acid Selenious Acid American Regent Sun Pharm 219547
02/21/2025 Ctexli Chenodiol Mirium Mirum N219488
02/21/2025 Lyrica Pregabalin Upjohn Torrent 206942
02/21/2025 Vibramycin Doxycycline Hyclate Pfizer Precision Dose 217078
02/21/2025 Anectine / Quelicin Succinylcholine Chloride Sandoz/Hospira Fresenius Kabi 217885
02/21/2025 CaroSpir Spironolactone CMP Dev. Hetero Labs 218085
02/24/2025 Rexulti Brexpiprazole Otsuka Apotex 213731
02/24/2025 Indocin Indomethacin Zyla Life Sciences Amneal 215399
02/24/2025 Thiamine HCl Thiamine HCl Fresenius Kabi Gland Pharma 217800
02/24/2025 Noxafil Posaconazole Merck Sharp & Dohme MSN 218434
02/24/2025 Lucemyra Lofexidine HCl US WorldMeds MSN 218699
02/25/2025  Combigan Brimonidine Tartrate / Timolol Maleate AbbVie Caplin 219093
02/26/2025 Migranal Dihydroergotamine Mesylate Bausch Aggrega 215228
02/26/2025 Lidex Fluocinonide Alvogen Quagen 216389
02/26/2025 Purixan Mercaptopurine Nova Labs Hikma 216418
02/27/2025 Eliquis Apixaban Bristol-Myers Squibb Macleods 210067
02/27/2025 Renvela Sevelamer Carbonate Genzyme Torrent 215909
02/27/2025 Retin-A Tretinoin Valeant Aurobindo 218245
02/27/2025 Bumex Bumetanide Validus Aspiro 218746
02/28/2025 Claritin Loratadine Bayer Healthcare Catalent 215127
02/28/2025 Allegra Fexofenadine HCl Chattem Sanofi Contract Pharmacal 219032
02/28/2025 Pataday Olopatadine HCl Alcon Labs Glenmark 219557
03/03/2025 Xarelto Rivaroxaban Janssen Lupin 208555
03/03/2025 Xarelto Rivaroxaban Janssen Taro 208557
03/03/2025 Sprycel Dasatinib Bristol-Myers Squibb Dr. Reddy's 213383
03/03/2025 Tamiflu Oseltamivir Phosphate Roche Jubilant 213695
03/03/2025 Revlimid Lenalidomide Bristol-Myers Squibb Biocon Pharma 215759
03/03/2025 Sprycel Dasatinib Bristol-Myers Squibb Biocon Pharma 217217
03/03/2025 Retin-A Tretinoin Valeant Encube 217587
03/03/2025 Retin-A Tretinoin Bausch Encube 217588
03/03/2025 Serax Oxazepam Alpharma  Leading 218261
03/03/2025 Micardis HCT Hydrochlorothiazide / Telmisartan Boehringer Ingelheim Mankind Pharma 218406
03/03/2025 Sprycel Dasatinib Brystol-Myers Squibb Zydus 218719
03/04/2025 Vesicare Solifenacin Succinate Astellas Torrent 209424
03/04/2025 Halaven Eribulin Mesylate Esai Chia Tai Tianqing 218743
03/05/2025 Nexium Esomeprazole Magnesium AstraZeneca Torrent 212651
03/05/2025 Nexium Esomeprazole Magnesium AstraZeneca Torrent 212652
03/05/2025 Levothyroxine Sodium Levothyroxine Sodium Fresenius Kabi Steriscience 216729
03/05/2025 Divigel Estradiol Vertical Pharms Encube 218507
03/06/2025 Revatio Sildenafil Citrate Viatris Jubilant 202954
03/07/2025 Brovana Arformoterol Tartrate Lupin Micro Labs 218555
03/07/2025 Nizoral Ketoconazole Janssen Zydus 218559
03/10/2025 Folotyn Pralatrexate Acrotech Biopharma Dr. Reddy's 206183
03/10/2025 Hiprex Methenamine Hippurate Esjay Zydus 219661
03/11/2025 Akovaz Ephedrine Sulfate Exela/Nexus Fresenius Kabi 218271
03/12/2025 Proventil Albuterol Sulfate Schering Ritedose 218386
03/12/2025 Kenalog-10 Triamcinolone Acetonide Apothecon Dr. Reddy's 218773
03/13/2025 Arbli Losartan Scienture Scienture N218772
03/13/2025 Fosrenol Lanthanum Carbonate Takeda Alkem 202329
03/13/2025 Riomet Metformin HCl Ranbaxy Annora Pharma 215008
03/13/2025 Buspar Buspirone HCl Bristol-Myers Squibb Epic Pharma 218628
03/14/2025 Viberzi Eluxadoline AbbVie Zydus 213522
03/14/2025 Mucomyst Acetylcysteine Apothecon Conba 214177
03/14/2025 Chronulac Lactulose Sanofi Pai 217914
03/14/2025 Zavesca Miglustat Actelion Navinta 219111
03/17/2025 Erleada Apalutamide Janssen Biotech Zydus 217113
03/17/2025 Lumigan Bimatoprost AbbVie Mankind Pharma 218196
03/17/2025 Kytril Granisetron HCl Hoffmann La Roche Intra Sana Labs 219282
03/18/2025 Trilafon Perphenazine Schering Jubilant 213694
03/18/2025 Emflaza Deflazacort PTC Therap Sun Pharm 217741
03/19/2025 Entadfi Finasteride / Tadalafil Blue Water Biotech Novitium 218499
03/20/2025 Durezol Difluprednate Sandoz Mylan 212566
03/21/2025 Vancomycin HCl Vancomycin HCl Mylan Gland 218140
03/21/2025 Levophed Norepinephrine Bitartrate Hospira Biocon Pharma 219443
03/21/2025 Naropin Ropivacaine HCl Fresenius Kabi Anthea Pharma 219883
03/24/2025 Cardizem SR Diltiazem HCl Biovail Labs AMTA 219073
03/25/2025 Ztlido Lidocaine Scilex Pharms Aveva 217221
03/25/2025 Pepcid Famotidine Bausch Health Beximco Pharms 218631
03/26/2025 Draximage DTPA Technetium Tc-99M Pentetate Kit Jubilant Curium 215146
03/26/2025 Zinecard Dexrazoxane HCl Pfizer MSN 216748
03/26/2025 Theophylline Theophylline Bausch Ajanta 218401
03/27/2025 Oracea Doxycycline Galderma Macleods 210381

[View source.]

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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