ANDA Approvals

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

Fourth Quarter

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