ANDA Approvals

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

Third 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
07/01/2022	Haldol	Haloperidol	Ortho McNeil	Actavis
07/01/2022	Zovirax	Acyclovir	Mylan	Hetero Labs
07/05/2022	Adderall	Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate	Teva	Cediprof
07/05/2022	Kenalog-40	Triamcinolone Acetonide	Apothecon	Eugia Pharma
07/05/2022	Cuyposa	Glycopyrrolate	Merz	Suven Pharms
07/05/2022	Cuyposa	Glycopyrrolate	Merz	Annora Pharma
07/06/2022	Dyrenium	Triamterene	Concordia	Eywa
07/06/2022	Bloxiverz	Neostigmine Methylsulfate	Exela	Dr Reddy's Labs
07/07/2022	Synjardy	Empagliflozin / Metformin HCl	Boehringer-Ingelheim	Zydus
07/07/2022	Vasotec	Enalapril Maleate	Bausch	Prinston
7/8/2022	Adderall	Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate	Teva	Lannett
07/08/2022	Isordil	Isosorbide Dinitrate	Bausch	Rubicon
07/12/2022	Vimpat	Lacosamide	UCB	Accord Healthcare
07/12/2022	Lexiscan	Regadenoson	Astellas	Gland Pharma
07/12/2022	Zithromax	Azithromycin	Pfizer	ACI
07/13/2022	Nystatin	Nystatin / Triamcinolone Acetonide	Cossette	Macleods
07/13/2022	Relpax	Eletriptan Hydrobromide	Pfizer	Beximco Pharms
07/13/2022	Neostigmine Methylsulfate	Neostigmine Methylsulfate	Fresenius Kabi	Hikma
07/14/2022	Ditropan	Oxybutynin Chloride	Janssen	Beximco Pharms
07/14/2022	Compazine	Prochlorperazine Edisylate	GlaxoSmithKline	Eugia Pharma
07/14/2022	Atropine Sulfate	Atropine Sulfate	Akorn	Amneal
07/14/2022	Robaxin	Methocarbamol	Hikma	Baxter Healthcare
07/14/2022	Floxin Otic	Ofloxacin	Bausch	Mankind
07/15/2022	Jublia	Efinaconazole	Bausch	Zydus
07/15/2022	Keppra	Levetiracetam	UCB	MSN
07/15/2022	Zithromax	Azithromycin	Pfizer	ACI
07/15/2022	Prolixin	Fluphenazine HCl	Bristol Myers Squibb	Apotex
07/18/2022	Vasostrict	Vasopressin	Par	Amphastar Pharms
07/18/2022	Prepopik	Sodium Picosulfate / Magnesium Oxide / Anhydrous Citric Acid	Ferring	Hetero Labs
07/18/2022	Nalfon	Fenoprofen Calcium	Xspire	Rising
07/18/2022	Lyrica	Pregabalin	Pfizer	Marksans Pharma
07/19/2022	Esbriet	Pirfenidone	Genentech	Laurus
07/19/2022	Dibenzyline	Phenoxybenzamine HCl	Concordia	Novitium Pharma
07/19/2022	Librax	Chlordiazepoxide HCl / Clidinium Bromide	Bausch	Micro Labs
07/19/2022	Levophed	Norepinephrine Bitartrate	Hospira	Zydus
07/20/2022	Edarbi	Azilsartan Medoxomil	Azurity	Lupin
07/20/2022	Macrobid	Nitrofurantoin Monohydrate / Macrocrystals	Alamatica	Alvogen
07/20/2022	Cambia	Diclofenac Potassium	Assertio	Alkem Labs
07/21/2022	Esbriet	Pirfenidone	Genentech	Aizant
07/21/2022	Letairis	Ambrisentan	Gilead	Aurobindo
07/22/2022	Minocin	Minocycline HCl	Melinta	Nexus Pharms
07/25/2022	Tamiflu	Oseltamivir Phosphate	Roche	Accord Healthcare
07/25/2022	Zebeta	Bisoprolol Fumarate	Teva	Cadila
07/25/2022	K-Tab	Potassium Chloride	AbbVie	Rubicon
07/25/2022	Epzicom	Abacavir Sulfate / Lamivudine	ViiV	Laurus
07/26/2022	Velcade	Bortezomib	Takeda	Dr Reddy's Labs
07/26/2022	Velcade	Bortezomib	Takeda	Sandoz
07/26/2022	Velcade	Bortezomib	Takeda	Accord Healthcare
07/26/2022	Velcade	Bortezomib	Takeda	Hospira
07/26/2022	Velcade	Bortezomib	Takeda	MSN
07/26/2022	Zetia	Ezetimibe	Organon	Hetero Labs
07/26/2022	Zithromax	Azithromycin	Pfizer	Yung Shin Pharm
07/26/2022	Velcade	Bortezomib	Takeda	Meitheal
07/26/2022	Velcade	Bortezomib	Takeda	Jiangsu Hansoh Pharm
07/26/2022	Protonix	Pantoprazole Sodium	Wyeth	Mankind
07/27/2022	Solaraze	Diclofenac Sodium	Novartis / Fougera	Aleor Dermaceuticals
07/27/2022	Taytulla	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	AbbVie	Glenmark
07/27/2022	Ofirmev	Acetaminophen	Mallinckrodt	Aspiro
07/29/2022	Librax	Chlordiazepoxide HCl / Clidinium Bromide	Bausch	Westminster Pharms
08/01/2022	Esbriet	Pirfenidone	Genentech	ScieGen Pharms
08/02/2022	Soolantra	Ivermectin	Galderma	Zydus
08/02/2022	Neoral	Cyclosporine	Novartis	Strides Pharma
08/03/2022	Jardiance	Empagliflozin	Boehringer-Ingelheim	Zydus
08/03/2022	Bactroban	Mupirocin	GlaxoSmithKline	Padagis
08/04/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Amneal
08/04/2022	Epiduo Porte	Adapalene / Benzoyl Peroxide	Galderma	Aleor Dermaceuticals
08/04/2022	Bumex	Bumetanide	Validus	MSN
08/04/2022	Chlorthalidone	Chlorthalidone	Mylan	Mankind Pharma
08/04/2022	Pepcid	Famotidine	Salix	Amneal
08/05/2022	Nuvaring	Ethinyl Estradiol / Etonogestrel	Organon	Mayne Pharma
08/05/2022	Vasostrict	Vasopressin	Endo / Par	Amneal
08/05/2022	Clindagel	Clindamycin Phosphate	Bausch	Amneal
08/08/2022	Trandate	Labetalol HCl	Alvogen	Unichem
08/08/2022	Decadron	Dexamethasone	Merck	Novitium Pharma
08/08/2022	Cardizem CD	Diltiazem HCl	Bausch	Amta
08/08/2022	Procomp	Prochlorperazine Maleate	Jubilant	Zydus
08/09/2022	Hemabate	Carboprost Tromethamine	Pfizer	Long Grove Pharms
08/10/2022	Divigel	Estradiol	Vertical	Chemo Research
08/11/2022	Antivert	Meclizine HCl	Casper	Lupin
08/11/2022	Adcirca/Cialis	Tadalafil	Eli Lilly	Prinston
08/11/2022	Rexulti	Brexpiprazole	Otsuka	Teva
08/12/2022	Cetrotide	Cetrorelix Acetate	Merck Serono	Akorn
08/15/2022	Vasostrict	Vasopressin	Endo / Par	Eugia Pharma
08/15/2022	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Unichem
08/16/2022	Atrovent	Ipratropium Bromide	Boehringer-Ingelheim	Amneal
08/17/2022	Banzel	Rufinamide	Eisai	Lupin
08/17/2022	Cerdelga	Eliglustat Tartrate	Celgene	Dr Reddy's Labs
08/17/2022	Naproxen	Naproxen Sodium	Bionpharma	Strides Pharma
08/18/2022	Dextrostat	Dextroamphetamine Sulfate	Shire	Tris Pharma
08/18/2022	Pennsaid 2%	Diclofenac Sodium	Horizon	Amneal
08/18/2022	Naropin	Ropivacaine HCl	Fresenius Kabi	Gland Pharma
08/18/2022	Otezla	Apremilast	Amgen	Teva
08/18/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Baxter Healthcare
08/18/2022	Kuvan	Sapropterin Dihydrochloride	Biomarin	Annora Pharma
08/18/2022	Zovirax	Acyclovir	Mylan	Rubicon
08/18/2022	Cubicin	Daptomycin	Cubist	Hainan Poly Pharm
08/18/2022	Merrem	Meropenem	Pfizer	Brooks Steriscience
08/18/2022	Tegretol XR	Carbamazepine	Novartis	Umedica Labs
08/19/2022	Riomet	Metformin HCl	Sun	Vistapharm
08/19/2022	DDAVP	Desmopressin Acetate	Ferring	Dr Reddy's Labs
08/22/2022	Fentora	Fentanyl Citrate	Teva	Mayne Pharma
08/22/2022	Zyvox	Linezolid	Pfizer	Hikma
08/22/2022	Depo-Provera	Medroxyprogesterone Acetate	Pfizer	Eugia Pharma
08/22/2022	Tegretol	Carbamazepine	Novartis	Unichem
08/22/2022	Brovana	Formoterol Fumarate	Mylan	Lupin
08/22/2022	Mucinex D	Guaifenesin / Pseudoephedrine HCl	Indivior	Granules
08/23/2022	Kuvan	Sapropterin Dihydrochloride	Biomarin	Annora Pharma
08/24/2022	Vimovo	Naproxen / Esomeprazole Magnesium	Horizon	Actavis
08/24/2022	Seroquel	Quetiapine Fumarate	AstraZeneca	Prinston
08/24/2022	Rozerem	Ramelteon	Takeda	Enaltec
08/25/2022	Accolate	Zafirlukast	Strides	Rising Pharms
08/25/2022	Toradol	Ketorolac Tromethamine	Roche	Hetero Labs
08/26/2022	Mexitil	Mexiletine HCl	Boehringer-Ingelheim	Aucta
08/26/2022	Lyrica CR	Pregabalin	Zydus	Zydus
08/26/2022	Nipride	Sodium Nitroprusside	Exela	Hainan Poly
08/26/2022	Vimpat	Lacosamide	UCB	Novitium Pharma
08/26/2022	Chlorthalidone	Chlorthalidone	Mylan	Alembic Pharms
08/29/2022	Sabril	Vigabatrin	Lundbeck	Hikma
08/29/2022	Protonix IV	Pantoprazole Sodium	Wyeth	Nanjing King-Friend
08/29/2022	Imodium	Loperamide HCl / Simethicone	Johnson & Johnson	Granules
08/30/2022	Revlimid	Lenalidomide	Celgene	Dr Reddy's Labs
08/30/2022	Ciprodex	Ciprofloxacin / Dexamethasone	Novartis	Sun Pharm
08/30/2022	Revlimid	Lenalidomide	Celgene	Apotex
08/30/2022	Revlimid	Lenalidomide	Celgene	Mylan
08/30/2022	Venlafaxine HCl	Venlafaxine HCl	Osmotica	Zydus
08/30/2022	Trileptal	Oxcarbazepine	Novartis	Rubicon
08/30/2022	Vazculep	Phenylephrine HCl	Exela	Mankind
08/31/2022	Revlimid	Lenalidomide	Celgene	Lotus Pharm
08/31/2022	Depo-Provera	Medroxyprogesterone Acetate	Pfizer	Eugia Pharma
08/31/2022	Lexiscan	Regadenoson	Astellas	Hospira
09/01/2022	Lyrica	Pregabalin	Upjohn	Prinston
09/01/2022	Adempas	Riociguat	Bayer	MSN
09/02/2022	Tri-Lo-Linyah	Ethinyl Estradiol / Norgestimate	Johnson & Johnson	Novast Labs
09/06/2022	Samsca	Tolvaptan	Otsuka	Hetero Labs
09/06/2022	Samsca	Tolvaptan	Otsuka	Apotex
09/06/2022	Revlimid	Lenalidomide	Celgene	Cipla
09/06/2022	Samsca	Tolvaptan	Otsuka	Alkem Labs
09/06/2022	Isuprel	Isoproterenol HCl	Bausch	Mylan
09/06/2022	Mutamycin	Mitomycin	Bristol Myers Squibb	Meitheal
09/06/2022	Onfi	Clobazam	Lundbeck	Accord Healthcare
09/07/2022	Gilenya	Fingolimod HCl	Novartis	Prinston
09/07/2022	Daliresp	Roflumilast	AstraZeneca	MSN
09/07/2022	Sabril	Vigabatrin	Lundbeck	MSN
09/07/2022	Timoptic	Timolol Maleate	Bausch	Micro Labs
09/08/2022	Lymphazurin	Isosulfan Blue	Mylan	Fresenius Kabi
09/08/2022	Mutamycin	Mitomycin	Bristol Myers Squibb	Meitheal
09/08/2022	Tambocor	Flecainide Acetate	Alvogen	Yichang Humanwell
09/08/2022	Dexamethasone	Dexamethasone	Hikma	Amneal
09/09/2022	Latuda	Lurasidone HCl	Sunovion	MSN
09/09/2022	Vraylar	Cariprazine HCl	AbbVie	Zydus
09/12/2022	Revlimid	Lenalidomide	Celgene	Zydus
09/12/2022	Carafate	Sucralfate	AbbVie	Mylan
09/13/2022	Prozac	Fluoxetine HCl	Eli Lilly	Piramal Healthcare
09/13/2022	Tazorac	Tazarotene	AbbVie	Cosette
09/13/2022	Zetia	Ezetimibe	Merck	Orient Pharma
09/13/2022	Timoptic in Ocudose	Timolol Maleate	Bausch	Ingenus Pharms
09/14/2022	Amicar	Aminocaproic Acid	Akorn	Optimus
09/14/2022	Lyrica CR	Pregabalin	Pfizer	ScieGen Pharms
09/14/2022	Vimpat IV	Lacosamide	UCB	Aspiro
09/15/2022	Geodon	Ziprasidone Mesylate	Viatris	MSN
09/16/2022	Dexilant	Dexlansoprazole	Takeda	TWi Pharms
09/16/2022	Lymphazurin	Isosulfan Blue	Covidien	MSN
09/19/2022	Byvalson	Nebivolol HCL / Valsartan	Allergan	Prinston
09/19/2022	Xylocaine	Lidocaine HCl	Fresenius Kabi	Sintetica Sa
09/19/2022	Cosopt	Dorzolamide HCl / Timolol Maleate	Thea Pharma	Gland Pharma
09/19/2022	Vimpat	Lacosamide	UCB	Gland Pharma
09/20/2022	Isuprel	Isoproterenol HCl	Bausch	Sti Pharma
09/21/2022	Pennsaid 2%	Diclofenac Sodium	Horizon	Lupin
09/21/2022	Esbriet	Pirfenidone	Genentech	Hetero Labs
09/21/2022	Sinemet	Carbidopa / Levodopa	Organon	Rubicon
09/22/2022	Timoptic XE	Timolol Maleate	Bausch	Dr Reddy's Labs
09/22/2022	Jadenu Sprinkle	Deferasirox	Novartis	Annora Pharma
09/22/2022	Bethkis	Tobramycin	Chiesi	Mankind
09/23/2022	Exjade	Deferasirox	Novartis	Teva
09/23/2022	Vimpat	Lacosamide	UCB	Apotex
09/23/2022	Voltaren XR	Diclofenac Sodium	Novartis	Riconpharma
09/23/2022	Cardizem	Diltiazem HCl	Bausch	ScieGen Pharms
09/23/2022	Pathocil	Dicloxacillin Sodium	Wyeth	Aurobindo
09/26/2022	Solu-Medrol	Methylprednisolone Sodium Succinate	Pfizer	Hikma
09/26/2022	Namenda	Memantine HCl	Allergan	Hetero Labs
09/26/2022	Vimpat	Lacosamide	UCB	Apotex
09/26/2022	Rexulti	Brexpiprazole	Otsuka	Sandoz
09/26/2022	Toprol XL	Metoprolol Succinate	AstraZeneca	Sunshine
09/26/2022	Lincocin	Lincomycin HCl	Pfizer	Gland Pharma
09/26/2022	Amicar	Aminocaproic Acid	Akorn	Aurobindo
09/28/2022	Myrbetriq	Mirabegron	Astellas	Lupin
09/28/2022	Mycamine	Micafungin Sodium	Astellas	Nanjing King-Friend
09/29/2022	Prezista	Darunavir	Johnson & Johnson	Lupin
09/29/2022	Pennsaid 2%	Diclofenac Sodium	Horizon	Taro
09/29/2022	Myrbetriq	Mirabegron	Astellas	Zydus
09/29/2022	Revatio	Sildenafil Citrate	Pfizer	Zydus
09/29/2022	Phenylephrine HCl	Phenylephrine HCl	Akorn	Mankind Pharma
09/30/2022	Vraylar	Cariprazine HCl	AbbVie	Sun Pharm