ANDA Approvals

New Drug Applications and 505(b)(2) Applications

Third Quarter

GENERICally Speaking

This ANDA Approvals 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 ANDA Holder ANDA Applicant
07/03/2023 Trileptal Oxcarbazepine   Novartis Zydus
07/03/2023 Pylera Bismuth Subcitrate Potassium / Metronidazole / Tetracycline HCl  AbbVie Riconpharma
07/05/2023 Jevtana Kit Cabazitaxel   Sanofi Mylan
07/05/2023 Immodium A-D Loperamide HCl   Johnson & Johnson Jubilant Cadista
07/06/2023 Vivitrol Naltrexone   Alkermes Teva
07/06/2023 Antizol Fomepizole   Par Gland Pharma
07/07/2023 Viibryd Vilazodone HCl   AbbVie Apotex
07/07/2023 Hexadrol Dexamethasone Sodium Phosphate   Aspen Global Geneyork Pharms
07/07/2023 Nicardipine Hydrochloride   Nicardipine HCl   Hikma Micro Labs
07/07/2023 Pepsid Famotidine   Salix Carnegie
07/10/2023 Rozerem Ramelteon   Takeda Aurobindo
07/10/2023 Advil Dual Action with Acetaminophen Acetaminophen / Ibuprofen   Glaxo Marksans Pharma
07/10/2023 Leucovorin Calcium Leucovorin Calcium   Hospira Hainan Poly
07/11/2023 Benicar Olmesartan Medoxomil   Cosette Amneal
07/11/2023 Renagel Sevelamer HCl   Genzyme Aurobindo
07/11/2023 Macrobid Nitrofurantoin (Monohydrate / Macrocrystals)   Almatica Mankind
07/11/2023 Sterile water for Injection  Sterile water for Injection   Hospira Nexus
07/11/2023 Xylocaine Lidocaine HCl   Fresenius Kabi Mankind
07/11/2023 Sodium Chloride Sodium Chloride 23.4%   Abraxis Fresenius Kabi
07/12/2023 Lyrica Pregabalin   Upjohn Cadila Pharms
07/12/2023 Potassium Chloride  Potassium Chloride   Pharma Res Software Novitium Pharma
07/12/2023 Nexium 24 hour Esomeprazole Magnesium   AstraZeneca Aurobindo
07/12/2023 MetroGel-Vaginal Metronidazole   Bausch Cosette
07/13/2023 Chlorpromazine HCl Chlorpromazine HCl   Upsher-Smith Lupin
07/13/2023 Oxtellar XR Oxcarbazepine   Supernus Apotex
07/13/2023 Advil Dual Action with Acetaminophen Acetaminophen / Ibuprofen   Glaxo Granules
07/13/2023 Steglatro Ertugliflozin   Pfizer / Merck Aurobindo
07/14/2023 Otezla Apremilast   Amgen Dr Reddys Labs
07/14/2023 Iclusig Ponatinib HCl   Takeda Apotex
07/14/2023 Zebeta Bisoprolol Fumarate   Teva Prinston
07/14/2023 Sodium Phenylacetate / Sodium Benzoate Sodium Phenylacetate / Sodium Benzoate   Maia Pharms Navinta
07/17/2023 Cytoxan Cyclophosphamide   Baxter Healthcare Sagent Pharms
07/17/2023 Cortef Hydrocortisone   Pharmacia and Upjohn Aurobindo
07/17/2023 Cardine Nicardipine HCl   Chiesi Senores Pharms
07/18/2023 Chlorpromazine HCl Chlorpromazine HCl   Upsher-Smith Labs Alembic
07/19/2023 Otezla Apremilast   Amgen Aurobindo
07/19/2023 Leucovorin Calcium Leucovorin Calcium   Hospira Kindos
07/19/2023 Neurontin Gabapentin   Viatris Rising
07/24/2023 Mozobil Plerixafor   Genzyme Dr Reddys Labs
07/24/2023 Mozobil Plerixafor   Genzyme Teva
07/24/2023 Mozobil Plerixafor   Genzyme MSN
07/24/2023 Bumex Bumetanide   Validus Pharms Taro
07/24/2023 Mozobil Plerixafor   Genzyme Eugia Pharma
07/24/2023 Aggrastat Tirofiban HCl   Medicure Nexus
07/24/2023 Mozobil Plerixafor   Genzyme Amneal
07/24/2023 Mozobil Plerixafor   Genzyme Kindos
07/25/2023 Ranexa Ranolazine   Gilead Piramal
07/25/2023 Hemabate Carboprost Tromethamine   Pfizer Steriscience
07/25/2023 Chantrix Varenicline Tartrate   PF Prism Medley Pharms
07/26/2023 Mozobil Plerixafor   Genzyme Zydus
07/26/2023 Otezla Apremilast   Amgen Annora
07/27/2023 Inomax Ulspira - Nitric Oxide Mallinckrodt Airgas Therapeutics
07/27/2023 Zithromax Azithromycin   Pfizer Hainan Poly
07/27/2023 Tobi Tobramycin   Mylan Micro Labs
07/28/2023 Rocaltrol Calcitriol   Validus Pharms Patrin
07/28/2023 Claritin Loratadine   Bayer Hetero Lab
07/28/2023 Azopt Brinzolamide   Novartis Padagis
07/28/2023 Mephyton Phytonadione   Bausch Health Sciegen Pharms Inc
07/28/2023 Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate   Fresenius Kabi Gene York Pharms
07/31/2023 LO/Ovral-28 Turqoz   Wyeth Lupin
07/31/2023 Onglyza Saxagliptin HCl AstraZeneca Amneal
07/31/2023 Onglyza Saxagliptin HCl AstraZeneca Aurobindo
07/31/2023 Onglyza Saxagliptin HCl AstraZeneca Mylan
07/31/2023 Kombiglyze ER Saxagliptin / Metformin HCl   AstraZeneca Mylan
07/31/2023 Onglyza Saxagliptin HCl AstraZeneca Glenmark
07/31/2023 Onglyza Saxagliptin HCl AstraZeneca Sun
07/31/2023 Kombiglyze ER Saxagliptin / Metformin HCl   AstraZeneca Sun
07/31/2023 Derma Smooth/FS Fluocinolone Acetonide   Hill Dermac Novel Labs
07/31/2023 Argatroban Argatroban   Hikma Gland Pharma
08/01/2023 Permethrin Permethrin   Aurobindo Dr Reddys Labs
08/01/2023 Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate   Fresenius Kabi Hikma
08/01/2023 Chantix Varenicline Tartrate   PF Prism Mankind Pharma
08/01/2023 Alphagan P Brimonidine Tartrate   AbbVie Alembic
08/01/2023 Advil Dual Action with Acetaminophen Acetaminophen / Ibuprofen   Glaxo Bionpharma
08/01/2023 Mucinex DM Guaifenesin / Dextromethorphan Hydrobromide   Reckitt Benckiser Dr Reddys Labs
08/02/2023 Indocin Indomethacin   Zyla Life Sciences Zydus
08/03/2023 Aptiom Eslicarbazepine Acetate   Sumitomo Pharma Hetero Labs
08/03/2023 Revlimid Lenalidomide   Celgene Torrent
08/03/2023 Zyloprim Allopurinol   Casper Pharma Hetero Lab
08/04/2023 Xiidra Lifitegrast   Novartis Micro Labs
08/04/2023 Diclegis Doxylamine Succinate / Pyridoxine HCl   Duchesnay Bionpharma
08/04/2023 Vancomycin HCl Vancomycin HCl   Mylan Eugia Pharma
08/04/2023 Bentyl Dicyclomine HCl   Allergan Bionpharma
08/07/2023 Derma-Smooth/FS Fluocinolone Acetonide   Hill Dermac Novel Labs
08/07/2023 Methotrexate Sodium Methotrexate Sodium   Strides Daito
08/07/2023 Toprol XL Metoprolol Succinate   Toprol Granules
08/07/2023 Denavir Penciclovir   Mylan Torrent
08/07/2023 Intuniv Guanfacine HCl   Takeda Alembic
08/07/2023 Hemabate Carboprost Tromethamine   Pfizer Gland Pharma
08/08/2023 Children's Motrin Ibuprofen   Johnson & Johnson Taro Pharms
08/09/2023 Kombiglyze XR Metformin HCl / Saxagliptin HCl   AstraZeneca Dr Reddys Labs
08/09/2023 Lotemax Loteprednol Etabonate   Bausch and Lomb  Sun
08/09/2023 Paraflex Chlorzoxazone   Ortho McNeil Graviti Pharms
08/10/2023 Lioresal Baclofen   Amneal Acic Pharms
08/11/2023 Diovan HCT Valsartan / Hydrochlorothiazide   Novartis Amneal
08/11/2023 Doryx MPC Doxycycline Hyclate   Mayne Pharma Lupin
08/11/2023 Lexette Halobetasol Propionate   Mayne Pharma Padagis
08/14/2023 Firazyr Icatibant Acetate   Takeda Eugia Pharma
08/14/2023 Aloxi Palonosetron HCl   Helsinn Healthcare Nanjing King-Friend
08/14/2023 Cozaar Losartan Potassium   Organon MSN Labs
08/14/2023 Potassium Chloride for Injection Concentrate Potassium Chloride   Hospira Nexus Pharms
08/14/2023 Lithium Citrate Syrup Lithium Citrate   Hikma Rubicon
08/15/2023 Bromday Bromfenac Sodium   Bausch and Lomb Lupin
08/15/2023 Toprol XL Metoprolol Succinate   AstraZeneca Lupin
08/15/2023 Trokendi XR Topiramate   Supernus Pharms Ajanta
08/15/2023 Thiola EC Tiopronin   Mission Pharmacal Amneal
08/15/2023 Aventyl Nortriptyline HCl   Ranbaxy Rubicon
08/16/2023 Silenor Doxepin HCl   Currax Zydus
08/16/2023 Zonalon Doxepin HCl   Mylan Amneal
08/16/2023 Balcoltra Levonorgestrel / Ethinyl Estradiol / Ferrous Fumarate   Avion Pharms Xiromed
08/17/2023 Selzentry Maraviroc   ViiV Healthcare I 3 Pharms
08/17/2023 Pepcid Famotidine   Salix Annora
08/17/2023 Hydroxyzine HCl Hydroxyzine HCl   Pliva Graviti Pharms
08/18/2023 Ultane Sevoflurane   AbbVie Shandong
08/18/2023 D.H.E. 45 Dihydroergotamine Mesylate   Bausch Health Gland Pharma
08/18/2023 Prolixin Fluphenazine HCl   Bristol-Myers Squibb Aurobindo
08/21/2023 Atacand Candesartan Cilexetil   ANI Pharms Prinston
08/21/2023 Morphine Sulfate Morphine Sulfate   Hikma SpecGx
08/21/2023 Calcium Gluconate Calcium Gluconate   Fresenius Kabi B Braun Medical
08/21/2023 Versed Midazolam HCl   HLR Technology Micro Labs
08/21/2023 Mucinex Guaifenesin   Reckitt Benckiser Marksans Pharma
08/21/2023 Sinequan Doxepin HCl   Pfizer  Unique Pharm
08/21/2023 Sutent Sunitinib Malate   CPPI Novugen
08/22/2023 Retin-A Micro Tretinoin Microsphere   Valeant Encube
08/22/2023 Zinc Sulfate Zinc Sulfate   America Regent Zydus
08/23/2023 Esbriet Pirfenidone   Genentech Lupin
08/23/2023 Chantix Varenicline Tartrate   PF Prism CV Alkem
08/23/2023 Invega Paliperidone   Janssen Ascent Pharms
08/23/2023 Bacteriostic Sodium Chloride Sodium Chloride 0.9%   Hospira Nexus Pharms
08/23/2023 Dexamethasone Dexamethasone   Hikma Apotex
08/24/2023 Divigel Estradiol   Vertical Pharms Novitium
08/24/2023 Restoril Temazepam   SpecGx Alkem Labs
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Actavis Elizabeth
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Hikma
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Amneal
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Mylan
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda SpecGx
08/25/2023 Niaspan Niacin   AbbVie  Eywa
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Sun
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Sun
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Norwich
08/25/2023 Combigan Brimonidine Tartrate / Timolol Maleate   AbbVie Alembic
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Rhodes
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Teva
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Lannett
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Prinston
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Apotex
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Ascent Pharms
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Alkem Labs
08/25/2023 Concerta Methylphenidate HCl   Johnson & Johnson Sun
08/25/2023 Xelganz Tofacitinib   PF Prism Sun
08/25/2023 Vyvanse Lisdexamfetamine Dimesylate   Takeda Ascent Pharms
08/28/2023 Esbriet Pirfenidone   Genentech  Lupin
08/28/2023 Effient Prasugrel HCl   Cosette Unichem
08/28/2023 Ibrance Palbociclib   Pfizer Synthon
08/28/2023 Noxafil Posaconazole   Merck Sharp Dohme I 3 Pharms
08/29/2023 Accutane Isotretinoin   Takeda Zydus
08/29/2023 CellCept Mycophenolate Mofetil   Roche Strides
08/29/2023 Viagra Sildenafil Citrate   Viatris Novitium
08/29/2023 Sterile water for Injection  Sterile water for Injection   Hospira American Regent
08/30/2023 Bentyl Dicyclomine Hydrochloride   Allergan Prinston
08/31/2023 Mydayis Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate Takeda Specgx
08/31/2023 Entereg Alvimopan Cubist Hikma
09/08/2023 Gadavist Gadobutrol Bayer Jiangsu Hengrui
09/11/2023 Diamox Acetazolamide Teva Ajanta Pharma
09/11/2023 CellCept Mycophenolate Mofetil Roche Airis Pharma
09/11/2023 Prolixin Fluphenazine HCl Bristol-Myers Squibb MSN Labs
09/12/2023 Lipitor Atorvastatin Calcium Upjohn Hetero Labs
09/13/2023 Augmentin Amoxicillin / Clavulanate Potassium US Antibiotics Deva Holding
09/14/2023 Prezista Darunavir Janssen Hetero Labs
09/14/2023 Ortho Evra Ethinyl Estradiol / Norelgestromin Janssen Zydus
09/14/2023 Advil Liqui-Gels Ibuprofen Glaxo Aurobindo
09/14/2023 Librax Chlordiazepoxide HCl / Clidinium Bromide Bausch Health Aurobindo
09/14/2023 Famotidine Famotidine Novitium Pharma Micro Labs
09/15/2023 Augmentin Amoxicillin / Clavulanate Potassium US Antibiotics Deva Holding
09/15/2023 Librax Chlordiazepoxide HCl / Clidinium Bromide Bausch Health Alembic
09/15/2023 Levophed Norepinephrine Bitartrate Hospira Caplin Steriles
09/18/2023 Pepcid  Famotidine Salix Ajanta
09/19/2023 Cleosin T Clindamycin Phosphate Pfizer Cadila Healthcare
09/21/2023 Diflucan Fluconazole Pfizer  Hainan Poly
09/21/2023 Mestinon Pyridostigmine Bromide Bausch Health MSN Labs
09/22/2023 Tegretol -;XR Carbamazepine Novartis Amneal
09/22/2023 Vascepa Icosapent Ethyl Amarin Strides
09/25/2023 AK-Fluor Fluorescein Sodium Long Grove Pharms Nexus Pharms
09/25/2023 Xeljanz Tofacitinib Citrate Pfizer Slayback
09/25/2023 Tapazole Methimazole King Pharms Bionpharma
09/26/2023 Depakote ER Divalproex Sodium AbbVie Annora Pharma
09/26/2023 Velcade Bortezomib Takeda Scinopharm
09/27/2023 Ranexa Ranolazine Gilead Novast Labs
09/27/2023 Topamax Topiramate Janssen Aurobindo
09/27/2023 Mydayis Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate Takeda Sun
09/28/2023 Uloric Febuxostat Takeda Macleods
09/28/2023 Aubagio Teriflunomide Sanofi Sola Pharms
09/29/2023 Nexium 24 hour Esomeprazole Magnesium AstraZeneca Marksans Pharma
09/29/2023 Hyzaar Losartan Potassium / Hydrochlorothiazide Organon Granules
09/29/2023 Vasopressin in Sodium Chloride Injection Vasopressin in Sodium Chloride Injection Endo / Par Baxter Healthcare

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