ANDA Approvals Second Quarter 2025

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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 #
04/02/2025 Liraglutide Liraglutide Novo Nordisk Nanjing King-Friend 218115
04/02/2025 Acetaminophen Acetaminophen B Braun Medical Gland 219215
04/02/2025 Xylocaine Lidocaine HCl Fresenius Kabi Anthea Pharma 219535
04/03/2025 Mycamine Micafungin Sodium Astellas Qilu Pharm Hainan 219273
04/03/2025 Bumex Bumetanide Validus Pharms Mankind 219291
04/03/2025 Colazal Balsalazide Disodium Valeant Pharms Carnegie 219422
04/04/2025 Aczone Dapsone AbbVie Aurobindo 218457
04/07/2025 Aubagio Teriflunomide Sanofi Aventis Concord Biotech 218663
04/08/2025 Dymista Azelastine HCl / Fluticasone Propionate Mylan Teva 208436
04/08/2025 Cuvposa Glycopyrrolate Merz Pharms MSN 216084
04/08/2025 Chantix Varenicline Tartrate PF Prism Shilpa 216615
04/08/2025 Emflaza Deflazacort PTC Therapeutics Zydus 219254
04/09/2025 Potassium Chloride Potassium Chloride Genus Lifesciences Ascent Pharms 211992
04/09/2025 Zortress Everolimus Novartis Biocon Pharma 216140
04/09/2025 Diclofenac Sodium Diclofenac Sodium Horizon Encube 217646
04/09/2025 Demser Metyrosine Bausch Cerovene 218620
04/10/2025 Lopressor Metoprolol Tartrate Rubicon Rubicon N219373
04/10/2025 Xarelto Rivaroxaban Janssen Aurobindo Pharma 208544
04/10/2025 Abraxane Paclitaxel Bristol Myers Squibb Cipla 209657
04/11/2025 Jadenu Deferasirox Novartis Jubilant 211660
04/11/2025 Kenalog-40 Triamcinolone Acetonide Apothecon Dr. Reddy's Labs 218421
04/14/2025 Carafate Sucralfate AbbVie Padagis 211780
04/14/2025 Gleevec Imatinib Mesylate Novartis Hetero 212975
04/14/2025 Zyloprim Allopurinol Casper Pharma Aurobindo 215091
04/14/2025 Zinc Chloride in plastic continer Zinc Chloride Hospira RK Pharma 217625
04/14/2025 Canasa Mesalamine AbbVie Rising 219028
04/14/2025 Riomet Metformin HCl Ranbaxy Bionpharma 219151
04/14/2025 Xalatan Latanoprost Upjohn Micro Labs 219306
04/15/2025 Mezofy Aripiprazole CMG Pharm CMG Pharm N211448
04/15/2025 Ranexa Ranolazine Menarini Jubilant Generics 211361
04/15/2025 Stalevo 50 Carbidopa / Entacapone / Levodopa Orion Pharma Macleods 214495
04/15/2025 Banzel Rufinamide Esai MSN 214817
04/15/2025 Nitroglycerin Nitroglycerin Fougera Pharms Encube 218235
04/15/2025 Alinia Nitazoxanide Romark Annora Pharma 218701
04/15/2025 Nexium Esomeprazole Magnesium AstraZeneca Aurobindo 218948
04/15/2025 Nexium Esomeprazole Magnesium AstraZeneca Aurobindo 219213
04/15/2025 Intuniv Guanfacine HCl Takeda Pharms Rubicon 219689
04/16/2025 Epzicom Abacavir Sulfate / Lamivudine ViiV Healthcare Hetero 205412
04/16/2025 Rowasa Mesalamine Mylan Novitium Pharma 215269
04/16/2025 Tegretol Carbamazepine Novartis Alembic 216623
04/16/2025 Frova Frovatriptan Succinate Endo Leading 216998
04/16/2025 Valcyte Valganciclovir HCl Cheplapharm Sph Zhongxi Pharm 218027
04/16/2025 Zebeta Bisoprolol Fumarate Teva Unique Pharm 219044
04/16/2025 Depo-Medrol Methylprednisolone Acetate Pfizer Hikma 219145
04/17/2025 Allegra-D Fexofenadine HCl / Pseudoephedrine HCl Chattem Sanofi Aurobindo 215232
04/17/2025 Vitamin K1 Phytonadione Hospira Caplin 219212
04/18/2025 Welchol Colesevelam HCl Cosette Macleods 204893
04/21/2025 Gleevec Imatinib Mesylate Novartis CSPC Ouyi 212193
04/22/2025 Qamzova Meloxicam Nanjing Delova Nanjing Delova N217593
04/22/2025 Sprycel Dasatinib Bristol Myers Squibb Eugia Pharma 216547
04/22/2025 Mayzent Siponimod Novartis Riconpharma 218444
04/23/2025 Jynarque Tolvaptan Otsuka Lupin 216063
04/23/2025 Noxafil Posaconazole Merck Qilu Pharm Hainan 217720
04/23/2025 Ganirelix Acetate Ganirelix Acetate Oraganon Qilu 218855
04/24/2025 Kloxxado Naloxone HCl Hikma Padagis 216719
04/25/2025 Chlorpromazine HCl Chlorpromazine HCl Upsher Smith Labs Aurobindo 216788
04/25/2025 Brovana Arformoterol Tartrate Lupin Saba Ilac Sanayi 218429
04/28/2025 Niaspan Niacin AbbVie Zydus 203285
04/28/2025 Corlanor Ivabradine HCl Amgen MSN 213483
04/28/2025 Vuity Pilocarpine HCl AbbVie Amneal 217733
04/28/2025 Hydroxyzine HCl Hydroxyzine HCl Chartwell Bionpharma 219289
04/29/2025 Celebrex Celecoxib Upjohn Strides 213127
04/29/2025 Vyzulta Latanoprostene Bunod Bausch and Lomb Gland 217387
04/29/2025 Kuvan Sapropterin Dihydrochloride BioMarin Pharm Shanghai Aucyun 218645
04/30/2025 Atzumi Dihydroergotamine Mesylate Satsuma Pharms Satsuma Pharms N217901
04/30/2025 Oxtellar XR Oxcarbazepine Supernus Aurobindo 219241
05/01/2025 Brilinta Ticagrelor AstraZeneca Apotex 208584
05/01/2025 Midazolam in 0.8% Sodium Chloride Midazolam Exela Sterinova 218454
05/01/2025 Zinc Sulfate Zinc Sulfate American Regent Aspiro 219585
05/01/2025 Flomax Tamsulosin HCl Sanofi Aventis Graviti Pharms 219767
05/02/2025 Wellbutrin SR Bupropion HCl GlaxoSmithKline Ipca Labs 207874
05/02/2025 Brilinta Ticagrelor AstraZeneca Alembic 208576
05/02/2025 Zovirax Acyclovir Bausch Cipla 212981
05/02/2025 Chantix Varenicline Tartrate PF Prism Aurobindo 214595
05/02/2025 Duobrii Halobetasol Propionate / Tazarotene Bausch Taro 217190
05/02/2025 Xarelto Rivaroxaban Janssen Apotex 217810
05/02/2025 Cortef Hydrocortisone Pharmacia / Upjohn Novitium Pharma 217881
05/02/2025 Ortho-Cept Desogestrel / Ethinyl Estradiol Janssen Avion Pharms 218933
05/05/2025 Brilinta Ticagrelor AstraZeneca Invagen 208537
05/05/2025 Azilect Rasagiline Mesylate Teva Torrent 210150
05/05/2025 Methadone HCl Methadone HCl Mylan Hikma 218609
05/06/2025 Chantix Varenicline Tartrate PF Prism Viwit Pharm 212879
05/06/2025 Myrbetrio Mirabegron Apgdi Sawai 217061
05/06/2025 Isentress HD Raltegravir Potassium Merck Sharp Dhome Lupin 217990
05/07/2025 Copaxone Glatiramer Acetate Teva Chemi 208468
05/12/2025 Hytrin Terazosin HCl Abbott Labs Ajanta 219482
05/12/2025 Zonegran Zonisamide Advanz Pharma Macleods 219507
05/13/2025 Docetaxel Docetaxel Shilpa Guangdong Sunho 213768
05/13/2025 Selzentry Maraviroc ViiV Healthcare Navinta 217880
05/13/2025 Bactroban Mupirocin GlaxoSmithKline Encube 217943
05/13/2025 Haldol Haloperidol Decanoate Janssen Caplin 219168
05/14/2025 Pradaxa Dabigatran Etexilate Mesylate Boehringer Ingelheim Aurobindo 208039
05/14/2025 Xarelto Rivaroxaban Janssen Dr. Reddy's Labs 208534
05/14/2025 Xarelto Rivaroxaban Janssen Invagen Pharms 208543
05/14/2025 Xarelto Rivaroxaban Janssen Lupin 208555
05/14/2025 Xarelto Rivaroxaban Janssen Alembic 210301
05/14/2025 Tribenzor Amlodipine Besylate/ Hydrochlorothiazide/ Olmesartan Medoxomil Cosette Piramal 210718
05/14/2025 Xarelto Rivaroxaban Janssen Macleods 213114
05/14/2025 Xarelto Rivaroxaban Janssen Sunshine 213348
05/14/2025 Xarelto Rivaroxaban Janssen Changzhou Pharm 216995
05/14/2025 Xarelto Rivaroxaban Janssen Biocon Pharma 218107
05/14/2025 Xarelto Rivaroxaban Janssen Ascent Pharms 219332
05/15/2025 Xarelto Rivaroxaban Janssen Breckenridge 208220
05/15/2025 Xarelto Rivaroxaban Janssen Aurobindo 208544
05/15/2025 Nasonex Mometasone Furoate Organon Naspress 211706
05/15/2025 Abraxane Paclitaxel Bristol Myers Squibb Shuangcheng 216355
05/16/2025 Crestor Rosuvastatin Calcium AstraZeneca Mankind 206603
05/16/2025 Iressa Gefitinib AstraZeneca Cipla 211826
05/16/2025 Protonix IV Pantoprazole Sodium Wyeth Deva Holding 215074
05/16/2025 Zyprexa Olanzapine Cheplapharm Qilu 218116
05/19/2025 Amicar Aminocaproic Acid Hikma Apozeal Pharms 213216
05/19/2025 Diazepam Diazepam Hospira Galenicum Health 216422
05/19/2025 Compazine Prochlorperazine Maleate GlaxoSmithKline Cerovene 217847
05/20/2025 Complera Emtricitabine / Rilpivirine HCl / Tenofovir Disoproxil Fumarate Gilead Sciences Mylan 208452
05/20/2025 Lyrica Pregabalin Upjohn Jubilant 209530
05/20/2025 Vidaza Azacitidine Bristol Myers Squibb Reliance Life 217453
05/20/2025 Lotemax Loteprednol Etabonate Bausch and Lomb Amneal 217484
05/21/2025 Chantix Varenicline Tartrate PF Prism Handa 213268
05/22/2025 Absorica Isotretinoin Sun Zydus 216633
05/22/2025 Caduet Amlodipine Besylate / Atorvastatin Calcium Pharmacia Alembic 217279
05/22/2025 Revlimid Lenalidomide Bristol Myers Squibb Deva Holding 217554
05/22/2025 Yutrepia Treprostinil Sodium Liquidia Tech Liquidia Tech N213005
05/23/2025 Bosulif Bosutinib Monohydrate PF Prism Alembic 209543
05/23/2025 Fycompa Perampanel Catalyst Teva 209801
05/23/2025 Vimpat Lacosamide UCB Westminster Pharms 218706
05/27/2025 Topamax Topiramate Janssen Rubicon 216683
05/28/2025 Relistor Methylnaltrexone Bromide Salix Mylan 208592
05/28/2025 Magnesium Sulfate Magnesium Sulfate Fresenius Kabi Aspiro 219777
05/29/2025 Zemuron Rocuronium Bromide Organon Mankind 219674
05/30/2025 Diamox Acetazolamide Teva Aurobindo 212089
06/02/2025 Ambisome Amphotericin B Astellas Avet Lifesciences 215354
06/02/2025 Apresoline Hydralazine HCl Novartis Kindos 217501
06/02/2025 Pepcid Famotidine Salix Lannett 217982
06/02/2025 Velcade Bortezomib Takeda Medicamen Biotech 218688
06/02/2025 Tranexamic Acid Tranexamic Acid Exela RTU Pharma 218896
06/03/2025 Giapreza Angiotensin II Acetate La Jolla Pharma Gland 216966
06/03/2025 Monurol Fosfomycin Tromethamine Zambon Precision Dose 217187
06/03/2025 Cetrotide Cetrorelix Acetate EMD Serano Xiromed 218061
06/03/2025 Epinephrine Epinephrine BPI Labs Gland 218144
06/04/2025 Janumet XR Metformin HCl / Sitagliptin Phosphate Merck Endo 204144
06/05/2025 Xifyrm Meloxicam Azurity Azurity N218395
06/05/2025 Prexxartan Valsartan Carmel Biosciences Rubicon 216460
06/05/2025 Flonase Fluticasone Propionate Haleon Rubicon 218321
06/06/2025 Bentyl Dicyclomine HCl Allergan Prinston 218310
06/09/2025 Zemuron Rocuronium Bromide Organon Fresenius Kabi N217472
06/09/2025 Halaven Eribulin Mesylate Esai Sandoz 214310
06/09/2025 Kuvan Sapropterin Dihydrochloride Biomarin Pharm Aurobindo 216797
06/09/2025 Lupron Leuprolide Acetate AbbVie Endo 217437
06/09/2025 Transderm Scop Scopolamine Baxter Healthcare Amneal 218384
06/10/2025 SPS Sodium Polystyrene Sulfonate CMP Pharma Lyne 214912
06/10/2025 Zinc Sulfate Zinc Sulfate American Regent Stira 217624
06/11/2025 Zyprexa Olanzapine Cheplapharm UBI 211072
06/11/2025 Pred Forte Prednisolone Acetate AbbVie Amneal 218256
06/11/2025 Lysteda Tranexamic Acid Amring Pharms Appco 218729
06/11/2025 Kuvan Sapropterin Dihydrochloride Biomarin Pharm Zenara 218797
06/11/2025 Selenious Acid Selenious Acid American Regent Aspiro 219633
06/12/2005 Zusduri Mitomycin Urogen Urogen N215793
06/12/2025 Qsymia Phentermine HCl / Topiramate Vivus Dr. Reddy's Labs 208175
06/12/2025 Hicon Sodium Iodide I-131 Jubilant Cardinal Health 213615
06/13/2025 Xadago Safinamide Mesylate MDD US Zenara 215913
06/13/2025 Cleocin T Clindamycin Phosphate Pfizer Carnegie 219612
06/16/2025 Mozobil Plerixafor Genzyme Hetero 217560
06/17/2025 Diamox Acetazolamide Sodium Teva Gland 219775
06/20/2025 Otezla Apremilast Amgen Torrent 211834
06/23/2025 Amitriptyline HCl Amitriptyline HCl Sandoz Unique Pharm 218389
06/23/2025 Meropenem Meropenem HQ Specialty Pharma Brooks Steriscience 219084
06/23/2025 Pepcid Famotidine Salix Bionpharma 219153
06/23/2025 Bentyl Dicyclomine HCl Allergan Rising 219242
06/23/2025 Ablysinol Alcohol BPI Labs Accord 217845
06/23/2025 Ablysinol Alcohol BPI Labs Xgen Pharms 219400
06/23/2025 Ablysinol Alcohol BPI Labs Breckenridge 219444
06/23/2025 Orapred Prednisolone Concordia Tulex Pharms 219509
06/24/2025 Diphenhydramine HCl Diphenhydramine HCl West-Ward Pharms Avet Lifesciences 205336
06/24/2025 Motegrity Prucalopride Succinate Takeda Hikma 217662
06/24/2025 Motegrity Prucalopride Succinate Takeda MSN 218177
06/24/2025 Motegrity Prucalopride Succinate Takeda Alkem 218295
06/24/2025 Motegrity Prucalopride Succinate Takeda Torrent 218778
06/24/2025 Motegrity Prucalopride Succinate Takeda Zenara 218795
06/24/2025 Motegrity Prucalopride Succinate Takeda SKG Pharma 218812
06/24/2025 Motegrity Prucalopride Succinate Takeda Lupin 218847
06/24/2025 Motegrity Prucalopride Succinate Takeda Appco 218963
06/24/2025 Motegrity Prucalopride Succinate Takeda Apotex 218977
06/24/2025 Motegrity Prucalopride Succinate Takeda Somerset Therapeutics 219078
06/24/2025 Motegrity Prucalopride Succinate Takeda Annora Pharma 219160
06/24/2025 Motegrity Prucalopride Succinate Takeda Aggrega 219193
06/24/2025 Motegrity Prucalopride Succinate Takeda H2-Pharma 219216
06/25/2025 Toprol-XL Metoprolol Succinate Toprol Ipca Labs 206980
06/25/2025 Cardene Nicardipine HCl Chiesi Navinta 218638
06/26/2025 Xarelto Rivaroxaban Janssen Alkem 218502
06/26/2025 Vimpat Lacosamide UCB Ajenat Pharms 219699
06/26/2025 Sodium Bicarbonate in plastic container Sodium Bicarbonate Abbott Labs Anthea Pharma 219701
06/27/2025 Avgemsi Gemcitabine Avyxa Avyxa N219920
06/27/2025 Doxil (Liposomal) Doxorubicin HCl Baxter Healthcare Alembic 219199
06/27/2025 Ganirelix Acetate Ganirelix Acetate Organon Tris Pharma 219454
06/30/2025 Ambisome Amphotericin B Astellas Mylan 212967
06/30/2025 Carnitor Levocarnitine Leadiant Biosciences Deva Holding 217430
06/30/2025 Myrbetriq Mirabegron Apgdi Qilu 217989
06/30/2025 Rogaine Extra Strength Minoxidil Kenvu Brands Taro 217998
06/30/2025 Lotemax SM Loteprednol Etabonate Bausch and Lomb Lupin 218087
06/30/2025 Emflaza Deflazacort PTC Therapeutics Aucta 219417
06/30/2025 Duexis Famotidine / Ibuprofen Horizon Medicines Aurobindo 219538

[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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