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
10/03/2022	Clolar	Clofarabine	Sanofi	Eugia Pharma
10/03/2022	Briviact	Brivaracetam	UCB	Zydus
10/04/2022	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Teva
10/04/2022	Valcyte	Valganciclovir HCl	Roche	Hetero Labs
10/05/2022	Corlanor	Ivabradine HCl	Amgen	Annora Pharma
10/06/2022	Lumigan 0.03%	Bimatoprost	Allergan	Eugia Pharma
10/06/2022	Vimovo	Naproxen / Esomeprazole Magnesium	Horizon	Ajanta
10/06/2022	Tegretol XR	Carbamazepine	Novartis	Novitium Pharma
10/07/2022	Solodyn ER	Minocycline HCl	Bausch	Sidmak Labs
10/07/2022	Abreva	Docosanol	Glaxo	Encube
10/07/2022	Keppra	Levetiracetam	UCB	MSN
10/11/2022	Ovcon 35	ethinyl estradiol / norethindrone	Warner Chilcott	Aurobindo
10/11/2022	Vfend	Voriconazole	Pfizer	Mylan
10/11/2022	Velcade	Bortezomib	Sanofi	Waverley Pharma
10/11/2022	Namenda XR	Memantine HCl	AbbVie	Xiamen LP Pharm
10/11/2022	Zyflo CR	Zileuton	Mylan	Annora Pharma
10/12/2022	Adcirca	tadalafil	Eli Lilly	Teva
10/12/2022	Theophylline Extended-Release Tablets	Theophylline	Bausch	Teva
10/13/2022	Dilantin	Extended Phenytoin Sodium	Viatris	Unichem
10/14/2022	Calcium Gluconate	Calcium Gluconate	Fresenius Kabi	Nivagen Pharms
10/17/2022	Lasix	Furosemide	Validus	Graviti Pharms
10/17/2022	Cytotec	Misoprostol	Pfizer	Micro Labs
10/18/2022	Tecfidera	Dimethyl Fumarate	Biogen	Prinston
10/18/2022	Cyclophosphamide	Cyclophosphamide	Baxter	Xellia Pharms Aps
10/18/2022	Neptazane	Methazolamide	Lederle	Tagi
10/18/2022	Toprol XL	Metoprolol Succinate	AstraZeneca	Accord Healthcare
10/19/2022	Doxil	Doxorubicin HCl (Liposomal)	J&J	Celerity Pharms
10/19/2022	Isuprel	Isoproterenol HCl	Bausch	American Regent
10/20/2022	Paraflex	Chlorzoxazone	J&J	Corepharma
10/20/2022	Taxol	Paclitaxel	HQ Specialty Pharma	Alembic Pharms
10/21/2022	Minipress	Prazosin HCl	Pfizer	Appco
10/21/2022	Cuyposa	Glycopyrrolate	Merz	Amneal
10/21/2022	Toradol	Ketorolac Tromethamine	Roche	Atnahs Pharma
10/21/2022	Toradol	Ketorolac Tromethamine	Roche	Zydus
10/24/2022	Prolixin	Fluphenazine HCl	Bristol-Myers Squibb	Upsher Smith Labs
10/24/2022	Mycamine	Micafungin Sodium	Astellas	Zydus
10/24/2022	Zaroxolyn	Metolazone	Lannett	Renata
10/24/2022	Vibra-Tabs	Doxycycline Hyclate	Pfizer	Amneal
10/25/2022	Abilify	Aripiprazole	Bristol-Myers Squibb	Glasshouse Pharms
10/25/2022	Zaroxolyn	Metolazone	Lannett	Aace Pharms
10/25/2022	Ofirmev	Acetaminophen	Mallinckrodt	Zydus
10/25/2022	Daraprim	Pyrimethamine	Vyera	Aurobindo
10/26/2022	Jevtana Kit	Cabazitaxel	Sanofi	Accord Healthcare
10/26/2022	Cuyposa	Glycopyrrolate	Merz	Alembic Pharms
10/26/2022	Lexiscan	Regadenoson	Astellas	Eugia Pharma
10/26/2022	Banzel	Rufinamide	Eisai	Aurobindo
10/26/2022	Narcan	Naloxone HCl	Bristol-Myers Squibb	Accord Healthcare
10/27/2022	Florinef	Fludrocortisone Acetate	Casper	Hikma
10/27/2022	Abilify	Aripiprazole	Bristol-Myers Squibb	Rubicon
10/28/2022	Naproxen	Naproxen Sodium	Bionpharma	Hetero Labs
10/28/2022	Lupron	Leuprolide Acetate	AbbVie	Amneal
10/28/2022	Trimethoprim	Trimethoprim	Mayne	Novitium Pharma
10/28/2022	Apriso	Mesalamine	Valeant	Alembic Pharms
10/31/2022	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Akorn
10/31/2022	Velcade	Bortezomib	Sanofi	Myla
10/31/2022	Zyvox	Linezolid	Pfizer	Hetero
10/31/2022	Cupric Chloride	Cupric Chloride	Pfizer	Exela Pharma
11/01/2022	Buphenyl	Sodium Phenylbutyrate	Horizon	Glenmark
11/02/2022	Kenalog-40	Triamcinolone Acetonide	Apothecon	Mylan
11/02/2022	Toradol	Ketorolac Tromethamine	Roche	Alembic Pharms
11/02/2022	Phenergan	Promethazine HCl	Mylan	Annora Pharma
11/03/2022	Ammonia N 13	Ammonia N 13	Feinstein	Univ Alahama Birmingham
11/03/2022	Bloxiverz	Neostigmine Methylsulfate	Exela	Nivagen Pharms
11/03/2022	Cleocin T	Clindamycin Phosphate	Pfizer	Amneal
11/03/2022	Lipitor	Atorvastatin Calcium	Pfizer	Lepu Pharm
11/04/2022	Trileptal	Oxcarbazepine	Novartis	Bionpharma
11/04/2022	Atropine Sulfate	Atropine Sulfate	Hospira	Medefil
11/04/2022	Ziac	Bisoprolol Fumarate / Hydrochlorothiazide	Teva	Cadila
11/04/2022	Amicar	Aminocaproic Acid	Akorn	Annora Pharma
11/07/2022	Banzel	Rufinamide	Eisai	Glasshouse Pharms
11/07/2022	Narcan	Naloxone HCl	Bristol-Myers Squib	Baxter Healthcare
11/07/2022	Imdur	Isosorbide Mononitrate	Schering Plough	Aurobindo
11/08/2022	Halcion	Triazolam	Pfizer	Sandoz
11/09/2022	Nexavar	Sorafenib Tosylate	Bayer	Yabao Pharm
11/09/2022	Denavir	Penciclovir	Mylan	Teva
11/09/2022	Prozac	Fluoxetine HCl	Eli Lilly and Co	Novitium Pharma
11/09/2022	Mexitil	Mexiletine HCl	Boehringer-Ingelheim	Annora Pharma
11/10/2022	Dizac	Diazepam	Pharmacia and Upjohn	Fresenius Kabi
11/10/2022	Cyclophosphamide	Cyclophosphamide	Hikma	Alembic Pharms
11/14/2022	Firvanq Kit	Vancomycin HCl	Azurity	Alkem Labs
11/14/2022	Bystolic	Nebivolol HCl	AbbVie	Mankind Pharma
11/15/2022	Bactroban	Mupirocin	Glaxo	Amneal
11/15/2022	Cyanocobalamin	Cyanocobalamin	American Regent	Sagent
11/15/2022	Keppra	Levetiracetam	UCB	MSN
11/15/2022	Brovana	Arformoterol Tartrate	Sunovion	Mankind Pharma
11/15/2022	Prolixin	Fluphenazine HCl	Bristol-Myers Squibb	Sandoz
11/15/2022	Prozac	Fluoxetine HCl	Eli Lilly and Co	Aptapharma
11/16/2022	Durezol	Difluprednate	Novartis	Dr Reddy's Labs
11/16/2022	DDAVP	Desmopressin Acetate	Ferring	Gland Pharma
11/17/2022	Potassium Chloride	Potassium Chloride	Genus	Strides
11/17/2022	AmBisome	Amphotericin B	Astellas	Eugia Pharma
11/17/2022	Gadavist	Gadobutrol	Bayer	Hengrui Pharma
11/17/2022	Valcyte	Valganciclovir HCl	Hoffman LaRoche	Aurobindo
11/18/2022	Haldol	Haloperidol	Ortho McNeil	MSN
11/18/2022	Procardia XL	Nifedipine	Pfizer	Pharmadax
11/18/2022	Procardia XL	Nifedipine	Pfizer	Alembic Pharms
11/21/2022	Eryped	Erythromycin Ethylsuccinate	Azurity	Cadila Pharms
11/22/2022	Compazine	Prochlorperazine Edisylate	GlaxoSmithKline	Hikma
11/22/2022	Pepcid	Famotidine	Merck	Zydus
11/22/2022	Mitomycin	Mitomycin	Bristol-Myers Squib	Gland Pharma
11/23/2022	Ocuflox	Ofloxacin	AbbVie	Mankind Pharma
11/23/2022	Lipitor	Atorvastatin Calcium	Pfizer	Biocon Pharma
11/25/2022	Bloxiverz	Neostigmine Methysulfate	Exela	Avet Lifesciences
11/25/2022	Rozerem	Ramelteon	Takeda	Xiromed
11/25/2022	Perforomist	Formoterol Fumarate	Mylan	Aucta
11/28/2022	Qudexy XR	Topiramate	Upsher Smith Labs	Zydus
11/28/2022	Cuyposa	Glycopyrrolate	Merz	Aspen
11/28/2022	Compazine	Prochlorperazine Edisylate	GlaxoSmithKline	Amneal
11/28/2022	Actigall	Ursodiol	Teva	Aurobindo
11/28/2022	Effexor XR	Venlafaxine HCl	Wyeth	Unique
11/28/2022	Sinemet	Carbidopa / Levodopa	Organon	Aurobindo
11/28/2022	Bentyl	Dicyclomine HCl	Allergan	Corepharma
11/28/2022	Brovana	Arformoterol Tartrate	Lupin	Slayback
11/29/2022	Pennsaid 2%	Diclofenac Sodium	Horizon	Alembic Pharms
11/30/2022	Noxafil	Posaconazole	Merck	Actavis
11/30/2022	Trileptal	Oxcarbazepine	Novartis	Aucta
12/01/2022	Vivelle-Dot	Estradiol	Novartis	Zydus
12/02/2022	Benicar	Olmesartan Medoxomil	Cosette	Prinston
12/02/2022	Brevibloc	Esmolol HCl	Baxter	HQ Spcecialty Pharma
12/02/2022	Tegretol XR	Carbamazepine	Novartis	Riconpharma
12/06/2022	Viibryd	Vilazodone HCl	AbbVie	Invagen Pharms
12/07/2022	Vivimusta	Bendamustine HCl	Slayback	Dr Reddy's Labs
12/07/2022	Vivimusta	Bendamustine HCl	Slayback	Accord Healthcare
12/07/2022	Vibramycin	Doxycycline Hyclate	Pfizer	Par
12/08/2022	Rapaflo	Silodosin	AbbVie	Zydus
12/08/2022	Noxafil	Posaconazole	Merck	Hetero Labs
12/08/2022	Desonide	Desonide	Padagis	Alembic
12/09/2022	Lyrica	Pregabalin	Pfizer	Zydus
12/09/2022	Kenalog in Orabase	Triamcinolone Acetonide	Delcor	Quagen
12/09/2022	Carnitor	Levocarnitine	Leadiant	Novitium Pharma
12/12/2022	Hetlioz	Tasimelteon	Vanda	Teva
12/12/2022	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Upsher Smith Labs
12/13/2022	Latuda	Lurasidone HCl	Sunovion	Alkem Labs
12/13/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Hong Kong
12/13/2022	Perforomist	Formoterol Fumarate	Mylan	Slayback
12/13/2022	Brevibloc	Esmolol HCl	Baxter	Amneal
12/14/2022	Bentyl	Dicyclomine HCl	Allergan	Rubicon
12/15/2022	Nimbex	Cisatracurium Besylate	AbbVie	Piramal
12/16/2022	Cupric Sulfate	Cupric Sulfate	Abraxis	American Regent
12/09/2022	Carnitor	Levocarnitine	Leadiant	Novitium Pharma
12/12/2022	Hetlioz	Tasimelteon	Vanda	Teva
12/12/2022	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Upsher Smith Labs
12/13/2022	Latuda	Lurasidone HCl	Sunovion	Alkem Labs
12/13/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Hong Kong
12/13/2022	Perforomist	Formoterol Fumarate	Mylan	Slayback
12/13/2022	Brevibloc	Esmolol HCl	Baxter	Amneal
12/14/2022	Bentyl	Dicyclomine HCl	Allergan	Rubicon
12/15/2022	Nimbex	Cisatracurium Besylate	AbbVie	Piramal
12/16/2022	Cupric Sulfate	Cupric Sulfate	Abraxis	American Regent
12/16/2022	Cardene	Nicardipine HCl	Chiesi	Glenmark
12/16/2022	Lasix	Furosemide	Sanofi	Mankind Pharma
12/20/2022	Hetlioz	Tasimelteon	Vanda	Apotex
12/20/2022	Symmetrel	Amantadine HCl	Endo	Humanwell Puracap
12/20/2022	Briviact	Brivaracetam	UCB	Lupin
12/21/2022	Alphagan P	Brimonidine Tartrate	Allergan	Apotex
12/21/2022	Synthroid	Levothyroxine Sodium	AbbVie	Macleods
12/21/2022	Uptravi	Selexipag	Actelion	Zydus
12/21/2022	Nicorette	Nicotine Polacrilex	GlaxoSmithKline	Fertin Pharma
12/21/2022	Dobutrex	Dobutamine HCl	Eli Lilly and Co	Hainan Poly
12/21/2022	Lincocin	Lincomycin HCl	Pfizer	Hainan Poly
12/22/2022	Tecfidera	Dimethyl Fumarate	Biogen	Aurobindo
12/22/2022	Faslodex	Fulvestrant	AstraZeneca	Alembic Pharms
12/22/2022	Noxafil	Posaconazole	Merck	Amneal
12/22/2022	Arranon	Nelarabine	Novartis	Dr Reddy's Labs
12/23/2022	Ranexa	Ranolazine	Gilead	Aurobindo
12/23/2022	Revatio	Sildenafil Citrate	Viatris	Aurobindo
12/23/2022	CellCept	Mycophenolate Mofetil HCl	Roche	Steriscience
12/23/2022	Cubicin	Daptomycin	Merck	Aspiro
12/27/2022	Vesicare	Solifenacin Succinate	Astellas	Aurobindo
12/27/2022	BiCNU	Carmustine	Avet	Accord Healthcare
12/27/2022	Zinc Sulfate	Zinc Sulfate	Fresenius Kabi	Fresenius Kabi
12/27/2022	Bentyl	Dicyclomine HCl	Allergan	Twi
12/28/2022	Halcion	Triazolam	Pfizer	Zydus
12/29/2022	Keveyis	Dichlorphenamide	Torrent	Torrent
12/30/2022	Potassium Chloride	Potassium Chloride	Genus	Guardian Drug
12/30/2022	Vidaza	Azacitidine	Celgene	Eugia Pharma
12/30/2022	Minipress	Prazosin HCl	Pfizer	Mankind Pharma