Line design
New Drug Applications and 505(b)(2) Applications
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
04/03/2023 Silenor Doxepin HCl   Currax MSN
04/04/2023 Effexor XR Venlafaxine HCl   Upjohn Nostrum 
04/04/2023 Diamox Acetazolamide   Teva Zydus
04/04/2023 Lexiscan Regadenoson   Astellas Mylan
04/04/2023 Sinemet Carbidopa / Levodopa   Organon Zydus
04/04/2023 Arranon Nelarabine   Novartis Amneal
04/04/2023 Compazine Prochlorperazine Maleate   GlaxoSmithKline Bionpharma
04/04/2023 Daliresp Roflumilast   AstraZeneca Camber / Hetero
04/05/2023 Bepreve Bepotastine Besilate   Bausch and Lomb Alembic
04/05/2023 Clindamycin Phosphate in Dextrose 5% Clindamycin Phosphate in Dextrose 5%   Abraxix Hikma
04/05/2023 Bepreve Bepotastine Besilate   Bausch and Lomb Alembic
04/06/2023 Cardizem LA Diltiazem HCl   Bausch Sciegen Pharms
04/06/2023 Evoxac Cevimeline HCl   Cosette Rubicon
04/07/2023 Otezla Apremilast   Amgen Shilpa
04/07/2023 Zithromax Azithromycin   Pfizer Zydus
04/10/2023 Kerydin Tavaborole   Anacor  Zydus
04/10/2023 Celebrex Celecoxib   Upjohn  Yabao Pharm
04/10/2023 Paraflex Chlorzoxazone   Ortho McNeil  Corepharma
04/10/2023 Sular Nisoldipine   Covis Amta
04/11/2023 Valcyte Valganciclovir HCl   Cheplapharm APPCO
04/11/2023 Zithromax Azithromycin   Pfizer Zydus
04/11/2023 Valcyte Valganciclovir HCl   Cheplapharm Appco
04/12/2023 Venlafaxine HCl   Venlafaxine HCl   Osmotica Ajanta Pharma
04/12/2023 Uceris Budesonide   Bausch Padagis
04/12/2023 Doryx Doxycycline Hyclate   Fresenius Kabi Gland Pharma
04/12/2023 Alrex Loteprednol Etabonate   Bausch and Lomb Akorn
04/12/2023 Nexavar Sorafenib Tosylate   Bayer Torrent
04/13/2023 Depo-Medrol Methylprednisolone Acetate   Pfizer Eugia Pharma
04/13/2023 Depo-Testosterone Testosterone Cypionate   Pfizer Xiromed
04/14/2023 Isuprel Isoproterenol HCl   Bausch Zydus
04/14/2023 Furadantin Nitrofurantoin   Casper Pharma Novitium Pharma
04/14/2023 Piperacillin / Tazobactam Piperacillin / Tazobactam   Wockhardt Bio Shandong
04/14/2023 RizaFilm Rizatriptan Benzoate IntelGenx IntelGenx
04/17/2023 Menostar Estradiol   Bayer Healthcare Zydus
04/17/2023 Prograf Tacrolimus   Astellas Hangzhou Zhongmei
04/17/2023 Daliresp Roflumilast   AstraZeneca Aurobindo
04/17/2023 Midazolam Midazolam   InfoRLife Hikma
04/17/2023 Compazine Prochlorperazine Maleate   GlaxoSmithKline Amneal
04/18/2023 Acetaminophen Acetaminophen   B Braun Medical Wockhardt Bio
04/18/2023 Daliresp Roflumilast   AstraZeneca Zydus
04/18/2023 Luxiq Betamethasone Valerate   Mylan Xiromed
04/18/2023 Daliresp Roflumilast   AstraZeneca Alkem
04/18/2023 Evoxac Cevimeline HCl   Cosette Aurobindo
04/19/2023 Viagra Sildenafil Citrate   Vaitris Macleods
04/19/2023 Nimbex Cisatracurium Besylate   AbbVie Hikma
04/19/2023 Renvela Sevelamer Carbonate   Sanofi Macleods
04/19/2023 Lopressor Metoprolol Tartrate   Validus Zydus
04/19/2023  Dexamethasone Dexamethasone   Hikma Bionpharma
04/19/2023 Acetadote Acetylcysteine   Cumberland Pharms Steriscience
04/20/2023 Trisenox Arsenic Trioxide   Cephalon Orbicular
04/20/2023 Vascepa Icosapent Ethyl   Amarin Pharms Zydus
04/21/2023 Brilinta Ticagrelor   AstraZeneca Alkem
04/21/2023 Metrocream Metronidazole   Galderma Labs Zydus
04/24/2023 Pepcid AC Famotidine   Johnson & Johnson / McNeil Alkem Labs
04/25/2023 Tazorac Tazarotene   Allergan Padagis
04/26/2023 Iressa Gefitinib   AstraZeneca Actavis
04/26/2023 Isuprel Isoproterenol HCl   Bausch Hikma
04/26/2023 Lyrica  Pregabalin   Upjohn  ACI
04/26/2023 Dexamethasone Dexamethasone   Hikma Bionpharma
04/27/2023 Thalomid Thalidomide    Celgene Natco
04/27/2023 Parafon Forte Chlorzoxazone   Janssen  Acme Labs
04/27/2023 Intuniv Guanfacine HCl   Takeda Ajanta
04/28/2023 Treanda Bendamustine HCl   Cephalon Mylan
04/28/2023 Sabril Vigabatrin   Lundbeck Propel Pharma
04/28/2023 Delestrogen Estradiol Valerate   Par Sterile Xiromed
05/01/2023 Amitriptyline HCl   Amitriptyline HCl   Sandoz Rubicon
05/01/2023 Aggrastat Tirofiban HCl   Medicure Eugia Pharma
05/01/2023 Celontin Methsuximide   Parke Davis Novitium Pharma
05/01/2023 Cosopt PF Dorzolamide HCl / Timolol Maleate   Thea Pharma Ingenus Pharms
05/02/2023 Ivanz Ertapenem Sodium   Merck Sun Pharm
05/02/2023 Cerdelga Eliglustat Tartrate   Genzyme  Zenara
05/03/2023 Ofirmev Acetaminophen   Mallinckrodt HQ Specialty Pharma
05/03/2023 Carafate Sucralfate   AbbVie Zydus
05/03/2023 Edetate Calcium Disodium Versenate   Bausch Health Casper Pharma
05/03/2023 Cardene Nicardipine HCl   Chiesi USA Square Pharms
05/04/2023 Motpoly XR Lacosamide Aucta Aucta
05/04/2023 Trokendi XR Topiramate   Supernus Par
05/08/2023 Zemuron Rocuronium Bromide   Organon USA Hong Kong
05/08.2023 Dibenzyline Phenoxybenzamine HCl   Concordia Aurobindo
05/08/2023 Timoptic in Ocudose Timolol Maleate   Bausch and Lomb Sentiss Pharma
05/09/2023 Ambien Zolpidem Tartrate Sanofi Almatica
05/09/2023 Diamox Acetazolamide   Teva Aarksih Pharms
05/09/2023  Dexamethasone Dexamethasone   Hikma Novitium Pharma
05/10/2023 Propylthiouracil   Propylthiouracil   Dava Pharms Macleods
05/10/2023 Toradol Ketorolac Tromethamine   Roche Palo Alto Caplin
05/11/2023 Abraxane Paclitaxel Abraxis Teva
05/11/2023 Docetaxel Docetaxel   Accord Healthcare Mylan
05/11/2023 Revlimid Lenalidomide   Celgene Hetero Labs
05/11/2023 Furadantin Nitrofurantoin   Casper Pharma Aurobindo
05/11/2023 Theophylline Theophylline   Bausch Rhodes 
05/11/2023 Fosamax Alendronate Sodium   Merck Novitium Pharma
05/11/2023 Bicnu Carmustine   Avet Lifesciences MSN
05/11/2023 Voltaren Diclofenac Sodium   Novartis Rubicon
05/12/2023 Lialda Mesalamine   Takeda  Sinotherapeutics
05/12/2023 Neurontin Gabapentin   Viatris Laurus
05/15/2023 Aubagio Teriflunomide   Sanofi Natco
05/15/2023 Pepcid  Famotidine   Johnson & Johnson Alkem
05/15/2023 Precedex  Dexmedetomidine HCl   Hospira Amneal
05/15/2023 Banzel Rufinamide   Esai Micro Labs
05/16/2023 Emend Fosaprepitant Dimeglumine   Merck Piramal Critical
05/16/2023 Nalfon Fenoprofen Calcium   Xspire Pharma Misemer
05/16/2023 Akovaz Ephedrine Sulfate   Exela Pharma Zydus
05/17/2023 Lymphazurin Isosulfan Blue   Covidien AM Regent
05/18/2023 Effexor XR Venlafaxine HCl   Upjohn Granules
05/19/2023 Hemabate Carboprost Tromethamine   Pfizer Welding
05/19/2023 Amitriptyline HCl Amitriptyline HCl   Sandoz Graviti Pharms
05/22/2023 Alimta Pemetrexed Eli Lilly Shilpa
05/22/2023 Fusilev Levoleucovorin Calcium   Spectrum Hainan Poly Pharm
05/23/2023 Brixadi Bupremorphine Braeburn Braeburn
05/23/2023 Allegra Fexofenadine HCl   Chattem Sanofi Aurobindo
05/23/2023 Concerta Methylphenidate HCl   Janssen Alkem
05/23/2023 Haldol Haloperidol Decanoate   Janssen Mankind Pharma
05/23/2023 Lexiscan Regadenoson   Astellas Baxter
05/24/2023 Tapazole Methimazole King Pharms Macleods
05/24/2023 Gilenya Fingolimod HCl   Novartis Bionpharma
05/24/2023 Zemuron Rocuronium Bromide   Organon Hikma
05/24/2023 Metronidazole Metronidazole  Hospira Amneal
05/25/2023 Orfadin Nitisinone   Swedish Orphan Zenara
05/25/2023 Hemabate Carboprost Tromethamine   Pfizer Eugia Pharma
05/26/2023 Renagel Sevelamer HCl   Genzyme Macleods Pharms
05/26/2023 Eliquis Apixaban   Bristol-Myers Squibb Aurobindo
05/26/2023 Vasostrict Vasopressin   Endo / Par Fresenius Kabi
05/26/2023 Timoptic Timolol Maleate   Bausch and Lomb Micro Labs
05/30/2023 Diastat Acudial Diazepam   Bausch  Novel Labs
05/30/2023 Ocalvia Obeticholic Acid   Intercept  Apotex
05/30/2023 Ocaliva Obeticholic Acid   Intercept  Lupin
05/30/2023 Ocaliva Obeticholic Acid   Intercept  MSN
05/30/2023 Rowasa Mesalamine   Mylan Speciality Encube
05/31/2023 Aczone Dapsone   Almirall Amneal
05/31/2023 Esbriet Pirfenidone   Genentech Apotex
05/31/2023 Iressa Gefitinib   AstraZeneca Natco
05/31/2023 Wellbutrin Bupropion HCl   GlaxoSmithKline Annora Pharma
05/31/2023 EC-Naprosyn Naproxen   Atnahs Pharma Tulex Pharms
06/01/2023 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Cosette Macleods
06/01/2023 Cellcept Mycophenolate Mofetil HCl   Roche  Bpi Labs
06/01/2023 Lyrica CR Pregabalin Upjohn Sinotherapeutics
06/01/2023 Bentyl Dicyclomine HCl   Allergan Twi
06/02/2023 Corgard Nadolol USWM Alembic
06/02/2023 Inspira Eplerenone Upjohn Annora Pharma
06/02/2023 Arranon Nelarabine Sandoz Nexus Pharms
06/05/2023 Treanda Bendamustine HCl  Cephalon Apotex
06/05/2023 Treanda Bendamustine HCl  Cephalon Kindos
06/05/2023 Reclast  Zoledronic Acid   Sandoz Hong Kong
06/05/2023 Foscavir Foscarnet Sodium   Clinigen Healthcare Avet Lifesciences
06/05/2023 Treanda Bendamustine HCl   Cephalon Eugia Pharma
06/06/2023 Vesicare Solifenacin Succinate Astellas Lannett
06/06/2023 Adcirca Tadalafil Eli Lilly Zydus
06/06/2023 Aczone Dapsone Almirall (Allergan) Acrux Dds
06/06/2023 Lovenox Enoxaparin Sodium Sanofi Aventis Be Pharms
06/06/2023 Apriso Mesalamine Valeant Pharms Amta
06/07/2023 Nexium  Esomeprazole Magnesium AstraZeneca Zydus
06/07/2023 Treanda Bendamustine HCl   Cephalon Nang Kuang Pharm
06/07/2023 Depo-Provera Medroxyprogesterone Acetate Pfizer Amneal
06/07/2023 Precedex  Dexmedetomidine HCl  Hospira Milla Pharms
06/07/2023 Mobic Meloxicam Boehringer Ingelheim Ascent Pharms
06/08/2023 Fleqsuvy Baclofen Azurity Slayback Pharma
06/08/2023 Colazel Balsalazide Disodium Valeant Pharms Zydus
06/09/2023 Latuda Lurasidone HCl  Sunovion Macleods
06/09/2023 Esbriet Pirfenidone  Genentech Apotex
06/09/2023 Bridion Sugammadex Sodium Merck Aspiro
06/09/2023 Ciprodex Ciprofloxacin / Dexamethasone   Novartis Akorn
06/09/2023 Nimbex Cisatracurium Besylate   Abbvie Caplin
06/12/2023 Athrotec Diclofenac Sodium / Misoprostol  Pfizer Zydus
06/12/2023 Chantix Varenicline Tartrate Pfizer Zydus
06/12/2023 Toprol-XL Metoprolol Succinate   Toprol Granules
06/13/2023 Lonsurf Tipiracil HCl / Trifluridine   Taiho Oncology Natco
06/13/2023 Katerzia Amlodipine Benzoate   Azurity Amneal
06/13/2023 Sandostatin Octreotide Acetate   Novartis Gland Pharma
06/13/2023 Keppra Levetiracetam   UCB Granules
06/14/2023 Xadago Safinamide Mesylate   MDD US Aurobindo
06/14/2023 Nasonex 24 Hr Allegy Mometasone Furoate   Perrigo Amneal
06/15/2023 Bridion Sugammadex Sodium   Merck Mylan
06/15/2023 Hectorol Doxercalciferol   Sanofi Alembic
06/15/2023 Sodium Bicarbonate Sodium Bicarbonate   Abbott Labs Omnivium Pharms
06/15/2023 Hemabate Carboprost Tromethamine   Pfizer Alembic
06/16/2023 Solodyn Minocycline HCl   Bausch Zydus
06/16/2023 MetroGel-Vaginal Metronidazole   Bausch Encube
06/16/2023 Protonix Pantoprazole Sodium   Wyeth  Dexcel
06/16/2023 Klor-Con Potassium Chloride   Upsher-Smith Rubicon
06/16/2023 Banzel Rufinamide  Eisai Aurobindo
06/16/2023 Pepcid  Famotidine Johnson & Johnson Appco
06/16/2023 Xylocaine Lidocaine HCl  Fresenius Kabi Mankind Pharma
06/16/2023 Lodoco Colchicine Agepha Pharma Agepha Pharma
06/20/2023 Dibenzyline Phenoxybenzamine HCl   Concordia Rising
06/20/2023 Spiriva HandiHaler Tiotropium Bromide  Boehringer Ingelheim Lupin
06/20/2023 Glumetza Metformin HCl   Santarus Vgyaan
06/20/2023 Noxafil Posaconazole  Merck Welding
06/20/2023 Toradol Ketorolac Tromethamine   Roche Aspiro
06/20/2023 Trokendi XR Topiramate Supernus Alkem Labs
06/21/2023 Samsca Tolvaptana  Otsuka  MSN
06/21/2023 Nebcin Tobramycin Sulfate   Eli Lilly Eugia Pharma
06/22/2023 Adzenys SR-ODT Amphetamine  Neos Theraps Actavis
06/22/2023 Sandostatin Octreotide Acetate   Novartis  Gland Pharma
06/22/2023 Migranal Dihydroergotamine Mesylate Bausch Rubicon
06/23/2023 Lastacaft Alcaftadine  AbbVie Eugia Pharma
06/23/2023 Bridion Sugammadex Sodium Merck Sandoz
06/23/2023 Sensorcaine Bupivacaine Hydrochloride   Fresenius Kabi Kindos
06/26/2023 Phenylphrine HCl Phenoxybenzamine HCl   Hikma Be Pharms
06/27/2023 Sinequan Doxepin HCl   Pfizer Micro Labs
06/28/2023 Vidaza Azacitidine Bristol-Myers Squibb Jiangsu Hansoh 
06/29/2023 Nuvaring Etonogestrel / Ethinyl Estradiol Merck  Xiromed
06/29/2023 Sabril Vigabatrin   Lundbeck Zenara
06/29/2023 Vancomycin HCl Vancomycin HCl  Mylan Hikma
06/30/2023 Nascobal Cyanocobalamin Endo Lupin
06/30/2023 Activella Estradiol / Norethindrone Acetate Amneal Aurobindo
06/30/2023 Faslodex Fulvestrant AstraZeneca Eugia Pharma

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