ANDA Approvals

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

Fourth Quarter

GENERICally Speaking

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 #
10/02/2023 Abilify Aripiprazole   Otsuka Sunshine 213037
10/02/2023 Potassium Phosphates   Potassium Phosphates   Fresenius Kabi American Regent 216274
10/02/2023 Levetiracetam in Sodium Chloride Levetiracetam   HQ Specialty Pharma Baxter Healthcare 217059
10/03/2023 Atripla Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate   Gilead Strides Pharma 201802
10/03/2023 Glucotrol XL Glipizide   Pfizer Rubicon Research 214874
10/03/2023 Tamiflu Oseltamivir Phosphate   Hoffman La Roche Invagen Pharms 217467
10/04/2023 Bridion Sugammadex   Merck Zydus 214290
10/05/2023 Tenex Guanfacine HCl   Promius Pharma I 3 Pharms 216828
10/05/2023 Glucophage XR Metformin HCl   EMD Serono Laurus Labs 217631
10/06/2023 Epivir Lamivudine   Gilead Hetero Labs 91475
10/06/2023 Aptiom Eslicarbazepine Acetate   Sumitomo Alkem Labs 211199
10/06/2023 Narcan Naloxone HCl   Adapt Pharma BPI Labs 216977
10/06/2023 Adderall Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate Teva Alkem Labs 217787
10/10/2023 Protopic Tacrolimus   Leo Pharma Encube Ethicals 212387
10/10/2023 Potassium Phosphates   Potassium Phosphates   Fresenius Kabi Amneal 216344
10/11/2023 Uptravi Selexipag   Actelion Alembic 214414
10/11/2023 Vimovo Naproxen / Esomeprazole Magnesium   Horizon Sciegen Pharms 217738
10/12/2023 Zosyn Piperacillin / Tazobactam   Wyeth Eugia Pharma 217409
10/12/2023 Mephyton Phytonadione Bausch Health Agnitio 213336
10/13/2023 Aczone Dapsone   AbbVie Encube Ethicals 212383
10/13/2023 Cerebyx Fosphenytoin Sodium   Parke Davis Gland Pharma 214926
10/16/2023 Otezla Apremilast   Amgen Glenmark 211674
10/16/2023 Lipitor Atorvastatin Calcium   Upjohn Cadila Pharms 212103
10/16/2023 Jadenu Deferasirox   Norvartis Aurobindo 214474
10/16/2023 Lotrimin Clotrimazole   Schering Plough Sciegen Pharms 216569
10/16/2023 Tranexamic Acid Tranexamic Acid Exela Pharma Amneal 217155
10/16/2023 Quelicin Succinylcholine Chloride   Hospira Eugia Pharma 217808
10/17/2023 Proamatine Midodrine HCl   Takeda  Novugen 211973
10/17/2023 Intuniv Guanfacine HCl   Takeda  Rubicon Research 216762
10/18/2023 Nexium Esomeprazole Magnesium   AstraZeneca Granules India 217427
10/18/2023 Adrucil Fluorouracil   Pharmacia and Upjohn Alembic 217676
10/18/2023 Januvia Sitagliptin Merck Zydus N211566
10/19/2023 Aczone Dapsone   AbbVie Amneal 209890
10/19/2023 Votrient Pazopanib   Novartis Sun Pharm Inds Ltd. 215837
10/19/2023 Votrient Pazopanib   Novartis Teva 217517
10/19/2023 Calcium Gluconate Calcium Gluconate Fresenius Kabi Somerset 217689
10/19/2023 Votrient Pazopanib HCl Novartis  Apotex  217713
10/20/2023 Diflucan Fluconazole   Pfizer Lupin 209146
10/20/2023 Depo-Testosterone Testosterone Cypionate   Pfizer Eugia Pharma 211817
10/20/2023 Bicnu Carmustine   Avet Life Sciences Alembic 215730
10/20/2023 Trileptal  Oxcarbazepine Novartis Hetero Labs 216749
10/23/2023 Chantix Varenicline Tartrate PF Prism Hetero Labs 214571
10/23/2023 Zeloda Capecitabine Cheplapharm Teyro Labs 217237
10/24/2023 Theo-Dur Theophylline   Schering Harman Finochem 214806
10/24/2023 Col-Probenecid Probenecid / Colchicine   Watson Rising 217030
10/24/2023 Sutent Sunitinib Malate   CP Pharmaceuticals Natco Pharma 218024
10/25/2023 Uloric Febuxostat   Takada Aurobindo 210741
10/25/2023 Rexulti Brexpiprazole   Otsuka Optimus Pharma 213758
10/26/2023 Naropin Ropivacaine HCl   Fresenius Kabi Mylan 206091
10/26/2023 Cytoxan (lyophilized) Cyclophosphamide   Baxter Sunny 215089
10/26/2023 Abreva Docosanol GlaxoSmithKline Taro Pharms 214454
10/26/2023 Nitrostat Nitroglycerine Viatris Aurobindo 217879
10/27/2023 Aczone Dapsone   Almirall Alembic 215718
10/27/2023 Protonix Pantoprazole Sodium Wyeth Annora Pharma 216139
10/30/2023 Mutamycin Mitomycin   Bristol Labs Eugia Pharma 216732
10/30/2023 Zofran ODT Odansetron Sandoz IPCA Labs 209389
10/31/2023 Aczone Dapsone   AbbVie Padagis 215087
10/31/2023 Principin Ampicillin Trihydrate Apothecon Aurobindo 216554
11/01/2023 Mucomyst Acetylcysteine   Apothecon Exela Pharma Science 205643
11/01/2023 Aczone Dapsone   Almirall Padagis 212657
11/01/2023 Abilify Aripiprazole   Otsuka Hetero Labs 216150
11/01/2023 Proamatine Midodrine HCl   Takeda  Mankind Pharma 217271
11/02/2023 Bloxiverz Neostigmine Methylsulfate   Exela Pharma Eugia Pharma 213244
11/02/2023 Rexulti Brexpiprazole   Otsuka Aurobindo 213659
11/02/2023 Fluphenazine Decanoate Fluphenazine Decanoate   Bristol-Myers Squibb MSN Labs 215365
11/02/2023 Efudex Fluorouracil   Bausch Encube Ethicals 215612
11/03/2023 Depo-Medrol Methylprednisolone Acetate   Pfizer Amneal 216502
11/03/2023 Macrobid Nitrofurantoin   Almatica Omsav Pharma 217073
11/03/2023 Janumet Sitagliptin / Metformin HCl Merck Zydus 216743
11/06/2023 Prolixin Fluphenazine HCl   Apothecon Glenmark 216350
11/07/2023 Xiidra Lifitegrast   Novartis Eugia Pharma 215063
11/08/2023 Lioresal Baclofen Norvartis Micro Labs 217687
11/08/2023 Evoxac Cevimeline HCl Cosette Bionpharma 218290
11/09/2023 Technetium TC-99M Sulpher Colloid Kit Technetium TC-99M Sulpher Colloid Kit Sun Jubilant 213516
11/13/2023 Vimpat Lacosamide UCB Apotex 216670
11/14/2023 Divigel Estradiol Vertical Pharms Padagis 216524
11/15/2023 Revex Nalmefene HCl Hikma Chengdu Shuode 216007
11/16/2023 Forteo Teriparatide   Eli Lilly Apotex 211097
11/16/2023 Forteo Teriparatide   Eli Lilly Teva 208569
11/16/2023 Ganifelix Acetate Ganirelix Acetate Organon USA Lupin 216075
11/17/2023 Gastrografin Diatrizoate Meglumine / Diatrizoate Sodium Bracco Annora Pharma 215049
11/17/2023 Trokendi XR Topiramate   Supernus Dr Reddys Labs 217231
11/20/2023 Neurontin Gabapentin Viatris IPCA Labs 208928
11/20/2023 Livalo Pitavastatin Calcium   Kowa Lupin 206029
11/20/2023 Rexulti Brexpiprazole   Otsuka Hetero Labs 213669
11/20/2023 Keppra Levetiracetam   UCB Strides 214673
11/20/2023 Benemid Probenecid Merck Rising 217020
11/20/2023 Sensorcaine Bupivacaine HCl Fresenius Kabi Somerset 217792
11/21/2023 Tigan Trimethobenzamide HCl King Pharmaceutical Avet Lifesciences 205950
11/21/2023 Eliquis Apixaban   Bristol-Myers Squibb Hetero Labs 210066
11/21/2023 Zovirax Acyclovir Bausch Health Alembic 212361
11/21/2023 Progesterone Progesterone Actavis Accord Healthcare 217707
11/22/2023 Suprep Bowel Prep Kit Sodium Sulfate / Potassium Sulfate / Magnesium Sulfate Braintree Labs Strides 215469
11/22/2023 Condylox Podofilox Allergan Padagis 211871
11/22/2023 Alphagan Brimonidine Tartrate Allergan Micro Labs 217846
11/22/2023 Prolensa Bromfenac Sodium Bausch & Lomb Lupin 206027
11/24/2023 Tamiflu Oseltamivir Phosphate   Roche  Hainan Poly 218009
11/27/2023 Accolate Zafirlukast Strides Pharma Aurobindo  213163
11/28/2023 Prezista Darunavir   Janssen Cipla 206288
11/28/2023 Prezista Darunavir   Janssen Aurobindo 210677
11/28/2023 Prezista Darunavir   Janssen Dr Reddys Labs 211578
11/28/2023 Rexulti Brexpiprazole   Otsuka Alkem Labs 213782
11/28/2023 Prezista Darunavir   Janssen MSN Labs 215389
11/28/2023 Viagra Sildenafil Citrate Viatris Cadila Pharms 218045
11/29/2023 Pulmacort Respules Budesonide AstraZeneca Eugia Pharma 216667
11/29/2023 Promacta Eltrombopag Choline Novartis  Teva 216774
11/29/2023 Agumentin 250 Amoxicillin / Clavulanate Potassium US Antibiotics Deva Holding AS 210374
11/29/2023 Corlanor Ivabradine HCl Amgen Zydus 213442
11/29/2023 Lotemax Loteprednol Etabonate Bausch and Lomb Slayback Pharma 213956
11/29/2023 Foscavir Foscarnet Sodium Clinigen Healthcare Beijing 213987
11/29/2023 Myfortic Mycophenolic Sodium  Novartis Airis Pharma 217031
12/01/2023 Revatio Sildenafil Citrate Viatris Granules 214556
12/01/2023 Hiprex Methenamine Hippurate SS Pharma Lyrus Life Sciences 217675
12/04/2023 Chantix Varenicline Tartrate PF Prism CV Lupin 211862
12/05/2023 Sandostatin Lar Octreotide Acetate Novartis Teva 210317
12/05/2023 Prednisone Prednisone Hikma Granulation Tech 212629
12/05/2023 Risperdal Consta Risperidone Janssen Teva 214068
12/05/2023 ProvayBlue Methylene Blue ProvePharm SAS Zydus 215636
12/05/2023 Banzel Rufinamide Eisai Hetero Labs 216841
12/05/2023 Topamax Topiramate Janssen TWi Pharms 217694
12/05/2023 Nitrostat Nitroglycerin Viatris Mankind Pharma 217970
12/05/2023 Sprycel Dasatinib Bristol-Myers Squibb Nanocopoeia 216099
12/06/2023 Gilenya Fingolimod HCl Novartis Ezra Ventures 207945
12/06/2023 Loestrin FE Ethinyl Estradiol / Norethindrone Acetate Teva Aurobindo 216558
12/06/2023 Vasostrict Vasopressin Par Cipla 217987
12/07/2023 Aptiom Eslicarbazepine Acetate Sumitomo Pharma Apotex 211236
12/07/2023 Lovaza Omega-3-Acid Ethyl Esters Woodward Slayback Pharma 211345
12/07/2023 Vascepa Icosapent Ethyl Amarin Pharms Ascent Pharms 216811
12/07/2023 Laryng-O-Jet Kit Lidocaine HCl International Medication Systems Taro Pharms 218182
12/08/2023 Plavix Clopidogrel Bisulfate Sanofi Alkem Labs 203632
12/08/2023 Prezista Darunavir Janssen Amneal 212493
12/08/2023 Augmentin ES-600 Amoxicillin / Clavulanate Potassium US Antibiotics Micro Labs 217805
12/11/2023 Augmentin 400 Amoxicillin / Clavulanate Potassium US Antibiotics Deva Holding AS 210416
12/11/2023 Alimta Pemetrexed Disodium Eli Lilly Prinston 216582
12/11/2023 Protonix Pantoprazole Sodium Wyeth Granules 217282
12/11/2023 Lodosyn Carbidopa Aton Beximco Pharms 217961
12/13/2023 Cyclophosphamide Cyclophosphamide Hikma Zydus 211552
12/13/2023 Prezista Darunavir Janssen Zydus 214085
12/13/2023 Ilwilfin Eflornithine HCl US WorldMeds US WorldMeds 215500
12/14/2023 Restasis Cyclosporine AbbVie  Teva 203880
12/14/2023 Zyloprim Allopurinol Casper Pharma Lupin 211807
12/14/2023 Librax Chlordiazepoxide HCl / Clidinium Bromide Bausch Torrent 217385
12/14/2023 Valium Diazepam Waylis Therap Aurobindo 217843
12/14/2023 Hydromorphone HCl Hydromorphone HCl Hikma Hikma 217812
12/15/2023 Vimpat Lacosamide UCB Zydus 204947
12/15/2023 Pradaxa Dabigatran Etexilate Mesylate Boehringer Ingelheim Apotex 208070
12/15/2023 Namzaric Donepezil HCl / Memantine HCl AbbVie ANI Pharms 208237
12/18/2023 Cytoxan (lyophilized) Cyclophosphamide Baxter RK Pharma 216958
12/19/2023 Uloric Febuxostat Takada Torrent 211837
12/19/2023 Klor-Con Potassium Chloride Upsher-Smith Labs Rising 217412
12/20/2023 Pepcid Famotidine Johnson and Johnson Contract Pharmacal 217669
12/21/2023 Lipitor Atorvastatin Calcium Upjohn ACI 217634
12/22/2023 Vimpat Lacosamide UCB MSN 215379
12/22/2023 Vascepa Icosapent Ethyl Amarin Pharms Humanwell Puracap 217919
12/22/2023 Pepcid Famotidine Johnson and Johnson Graviti Pharms 218181
12/26/2023 Noxafil Posaconazole Merck Fresenius Kabi 209983
12/26/2023 Noxafil Posaconazole Merck Mylan 211500
12/26/2023 Noxafil Posaconazole Merck Eugia Pharma 214842
12/26/2023 Alrex Loteprednol Etabonate Bausch and Lomb Lupin 215550
12/26/2023 Tepadina Thiotepa Adienne SA Kindos 216037
12/26/2023 Noxafil Posaconazole Merck Gland Pharma 217553
12/27/2023 Amicar Aminocaproic Acid Hikma Sunny Pharmatech 213213
12/27/2023 Marcaine Bupivacaine HCl Hospira Kindos 216040
12/27/2023 Nexium  Esomeprazole Magnesium AstraZeneca Zhejiang Yongtai 217022
12/28/2023 Temovate Clobetasol Propionate Fougera  Macleods 215990
12/29/2023 Lunesta Eszopiclone Woodward IPCA Labs 206222
12/29/2023 Suprep Bowel Prep Kit Magnesium Sulfate / Potassium Sulfate / Sodium Sulfate Braintree Labs Alkem Labs 213924

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