ANDA Approvals

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

Second 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
4/1/2022	Permitil	Fluphenazine HCl	Schering	TWi Pharms
4/4/2022	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Sandoz
4/5/2022	Paraflex	Chlorzoxazone	Johnson & Johnson	Rising
4/6/2022	Frova	Frovatriptan Succinate	Endo	Renata
4/6/2022	BiDiL	Isosorbide Dinitrate / Hydralazine HCl	Azurity	Riconpharma
4/7/2022	Noxafil	Posaconazole	Merck	Dr Reddy's
4/7/2022	Ganirelix	Ganirelix Acetate	Organon	Amphastar Pharms
4/7/2022	Bystolic	Nebivolol HCl	AbbVie	Prinston
4/7/2022	Allzital/Butapap	Butalbital / Acetaminophen	Larken / Mikart	Senores Pharms
4/7/2022	Vimpat	Lacosamide	UCB	Indoco
4/8/2022	Emla	Lidocaine / Prilocaine	Teva	Aleor Dermaceuticals
4/8/2022	Elcys	Cysteine HCl	Exela	Dr Reddy's
4/11/2022	Lexiscan	Regadenoson	Astellas	Apotex
4/11/2022	Lexiscan	Regadenoson	Astellas	Hong Kong
4/11/2022	Lexiscan	Regadenoson	Astellas	Dr Reddy's
4/11/2022	Lexiscan	Regadenoson	Astellas	Accord Healthcare
4/11/2022	Dotarem	Gadoterate Meglumine	Guerbet	Hengrui Pharma
4/11/2022	Sutent	Sunitinib Malate	Pfizer	Dr Reddy's
4/12/2022	Alphatrex	Betamethasone Dipropionate	Savage	Padagis
4/13/2022	Intelence	Etravirine	Johnson & Johnson	Carnegie
4/14/2022	Tikosyn	Dofetilide	Pfizer	Vgyaan
4/14/2022	Prolixin	Fluphenazine HCl	BMS	Taro Pharm
4/14/2022	Akovaz	Ephedrine Sulfate	Exela	Mankind Pharma
4/15/2022	Tikosyn	Dofetilide	Pfizer	Teva
4/15/2022	Dacogen	Decitabine	Otsuka	Jiangsu Hansoh Pharm
4/15/2022	Vibisone	Cyanocobalamin	Fresenius Kabi	Zydus
4/15/2022	Vibisone	Cyanocobalamin	Fresenius Kabi	Welding
4/15/2022	Carafate	Sucralfate	Allergan	Amneal Pharms
4/15/2022	Dotarem	Gadoterate Meglumine	Guerbet	Hengrui Pharma
4/19/2022	Mestinon	Pyridostigmine Bromide	Bausch	Milla Pharms
4/19/2022	Doxepin HCl	Doxepin HCl	Pfizer	Edenbridge Pharms
4/20/2022	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Apotex
4/20/2022	Thiamine HCl	Thiamine HCl	Fresenius Kabi	Eugia Pharma
4/21/2022	Akovaz	Ephedrine Sulfate	Exela	Aggrega
4/21/2022	Olux	Clobetasol Propionate	Mylan	Aleor Dermaceuticals
4/22/2022	Xtandi	Enzalutamide	Astellas	Apotex
4/22/2022	Vitamin K1	Phytonadione	Hospira	Cipla
4/26/2022	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Prinston
4/27/2022	Ranexa	Ranolazine	Gilead	I3 Pharms
4/27/2022	Targretin	Bexarotene	Bausch	Amneal
4/28/2022	Esbriet	Pirfenidone	Genentech	Sandoz
4/28/2022	Taytulla	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	Apil	Mayne Pharma
4/29/2022	Intal	Cromolyn Sodium	King	Micro Labs
4/29/2022	Imdur	Isosorbide Mononitrate	Schering	Shandong
5/2/2022	Velcade	Bortezomib	Takeda	Apotex
5/2/2022	Velcade	Bortezomib	Takeda	Teva
5/2/2022	Velcade	Bortezomib	Takeda	Sagent / Pharmascience
5/2/2022	Velcade	Bortezomib	Takeda	Fresenius Kabi
5/2/2022	Velcade	Bortezomib	Takeda	Zydus
5/2/2022	Velcade	Bortezomib	Takeda	Ingenus / Qilu Pharm Hainan
5/2/2022	Velcade	Bortezomib	Takeda	Eugia Pharma
5/2/2022	Velcade	Bortezomib	Takeda	Baxter Healthcare
5/2/2022	Tamiflu	Oseltamivir Phosphate	Roche	MSN
5/3/2022	Lyrica	Pregabalin	Pfizer	Lupin
5/3/2022	Zyflo CR	Zileuton	Chiesi	Teva
5/3/2022	Vimpat	Lacosamide	UCB	Fresenius Kabi
5/3/2022	Abreva	Docosanol	Glaxo	Aleor Dermaceuticals
5/3/2022	Zinc Sulfate	Zinc Sulfate	American Regent	Gland Pharma
5/4/2022	Pomalyst	Pomalidomide	Celgene	Teva
5/4/2022	Flomax	Tamsulosin HCl	Sanofi	Acme Labs
5/5/2022	Fanapt	Iloperidone	Vanda Pharms	Lupin
5/5/2022	Ranexa	Ranolazine	Gilead	Hetero Labs
5/5/2022	Northera	Droxidopa	Lundbeck	Celltrion
5/5/2022	Xylocaine	Lidocaine HCl	Fresenius Kabi	Sintetica
5/5/2022	Tiazac	Diltiazem HCl	Bausch	Mayne Pharma
5/6/2022	Pennsaid	Diclofenac Sodium	Horizon	Apotex
5/6/2022	Apriso	Mesalamine	Valeant	Teva
5/9/2022	Vfend	Voriconazole	PF Prism	Meitheal
5/10/2022	Norvir	Ritonavir	AbbVie	Cipla
5/10/2022	Synthroid	Levothyroxine Sodium	AbbVie	Teva
5/10/2022	Daliresp	Roflumilast	AstraZeneca	Prinston
5/10/2022	Noxafil	Posaconazole	Merck Sharp Dohme	Specgx
5/10/2022	Brovana	Arformoterol Tartrate	Sunovion	Alembic Pharms
5/10/2022	Sabril	Vigabatrin	Lundbeck	Aurobindo
5/11/2022	Requip XL	Ropinirole HCl	GlaxoSmithKline	Prinston
5/11/2022	Pentasa	Mesalamine	Takeda	Sun Pharm
5/11/2022	Cataflam	Diclofenac Potassium	Amici	Umedica Labs
5/13/2022	Nicorette	Nicotine Polacrilex	GlaxoSmithKline	Aurobindo
5/13/2022	Kuvan	Sapropterin Dihydrochloride	Biomarin	Dr Reddy's
5/16/2022	Bijuva	Estradiol / Progesterone	TherapeuticsMD	Amneal
5/17/2022	Butrans	Buprenorphine	Purdue	Alvogen
5/18/2022	Protonix IV	Pantoprazole Sodium	Wyeth	Gland Pharma
5/18/2022	Trilafon	Perphenazine	Schering	Appco
5/18/2022	Vantin	Cefpodoxime Proxetil	Pharmacia / Upjohn	Alkem Labs
5/18/2022	Esbriet	Pirfenidone	Genentech	Micro Labs
5/18/2022	Protonix IV	Pantoprazole Sodium	Wyeth	Aspiro
5/18/2022	Protonix IV	Pantoprazole Sodium	Wyeth	Be Pharms
5/19/2022	Letairis	Ambrisentan	Gilead	Apotex
5/19/2022	Visapaque	Iodixanol	GE Healthcare	Hengrui Pharma
5/19/2022	Vimpat	Lacosamide	UCB	Alkem Labs
5/19/2022	Protonix IV	Pantoprazole Sodium	Wyeth	Knack
5/20/2022	Esbriet	Pirfenidone	Genentech	Alembic Pharms
5/20/2022	Aromasin	Exemestane	Pfizer	Eugia Pharma
5/23/2022	Lexiscan	Regadenoson	Astellas	IMS
5/24/2022	Esbriet	Pirfenidone	Genentech	MSN
5/24/2022	Nimbex	Cisatracurium Besylate	AbbVie	Piramal
5/24/2022	Prilosec OTC	Omeprazole Magnesium	AstraZeneca	Perrigo
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Fresenius Kabi
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Hospira
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Dr Reddy's
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Accord Healthcare
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Apotex
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Qilu Pharm Hainan
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Nang Kuang Pharm
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Jiangsu Hansoh Pharm
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Apotex
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Biocon Pharma
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Waverley Pharma
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Zydus
5/25/2022	Alimta	Pemetrexed Disodium	Eli Lilly	Eugia Pharma
5/25/2022	Noxafil	Posaconazole	Merck	Par
5/26/2022	Orfadin	Nitisinone	Swedish Orphan	Medunik
5/26/2022	Zemuron	Rocuronium Bromide	Organon	Prinston
5/26/2022	Brovana	Arformoterol Tartrate	Sunovion	Sun Pharm
5/26/2022	Atropine Sulfate	Atropine Sulfate	Hospira	American Regent
5/26/2022	Bumex	Bumetanide	Validus	Gland Pharma
5/27/2022	Symmetrel	Amantadine HCl	Endo	Edenbridge Pharms
5/27/2022	Keppra	Levetiracetam	UCB	Sciegen Pharms
5/27/2022	Children's Motrin	Ibuprofen	Johnson & Johnson	Strides Pharma
5/27/2022	Minocycline HCl	Minocycline HCl	Triax	Beximco Pharms
5/27/2022	Keppra	Levetiracetam	UCB	Alkem Labs
5/31/2022	Vimpat	Lacosamide	UCB	Hetero Labs
5/31/2022	Epiduo Forte	Adapalene / Benzoyl Peroxide	Galderma	Padagis
5/31/2022	Concerta	Methylphenidate HCl	Johnson & Johnson	Rhodes Pharms
5/31/2022	Florinef	Fludrocortisone Acetate	Casper	Novitium Pharma
5/31/2022	Allegra-D	Fexofenadine HCl / Pseudoephedrine HCl	Sanofi	Dr Reddy's
5/31/2022	Advil PM	Ibuprofen / Diphenhydramine Citrate	GlaxoSmithKline	Aurobindo
6/1/2022	Aleve-D	Naproxen Sodium / Pseudoephedrine HCl	Bayer	Aurobindo
6/2/2022	Suboxone	Buprenorphine HCl / Naloxone HCl	Indivior	Aveva
6/2/2022	Thiola	Tiopronin	Mission	Par
6/3/2022	Epiduo Forte	Adapalene / Benzoyl Peroxide	Galderma	Zydus
6/3/2022	Pepcid	Famotidine	Johnson & Johnson	Zydus
6/6/2022	Lupron	Leuprolide Acetate	AbbVie	Eugia Pharma
6/6/2022	Potassium Chloride	Potassium Chloride	Genus Life Sciences	Wes Pharma
6/6/2022	Ganirelix	Ganirelix Acetate	Merck	Hong Kong
6/6/2022	Elavil	Amitriptyline HCl	AstraZeneca	Centaur Pharms
6/7/2022	Naprosyn	Naproxen	Atnahs Pharma	Hetero Labs
6/7/2022	Nexavar	Sorafenib Tosylate	Bayer	Dr Reddy's
6/8/2022	Kabilyte	Multiple Electrolytes Injection Type 1 USP Ph 7.4	Baxter	Fresenius Kabi
6/8/2022	Tenex	Guanfacine HCl	Promius	TWi Pharms
6/9/2022	Glumetza	Metformin HCl	Santarus	Prinston Inc
6/9/2022	Narcan	Naloxone HCl	Adapt	Mylan
6/9/2022	Infants Advil Concentrated Drops	Ibuprofen	Glaxo	Strides Pharma
6/9/2022	Briviact	Brivaracetam	UCB	Sunshine
6/9/2022	Xylocaine	Lidocaine HCl	Fresenius Kabi	Afaxys
6/10/2022	Narcan	Naloxone HCl	Adapt	Hikma
6/13/2022	Esbriet	Pirfenidone	Genentech	Sandoz
6/13/2022	Procomp	Prochlorperazine Maleate	Jubilant Cadista	Biophore / Zenara
6/14/2022	Lovenox	Enoxaparin Sodium	Sanofi	Nanjing King-Friend
6/14/2022	Tranxene	Clorazepate Dipotassium	Recordati	Corepharma
6/15/2022	Isoptin	Verapamil HCl	Mt Adams	Mankind Pharma
6/15/2022	Vesicare	Solifenacin Succinate	Astellas	Annora Pharma
6/16/2022	Seroquel	Quetiapine Fumarate	AstraZeneca	Hetero Labs
6/16/2022	Nasalide	Flunisolide	Ivax	Riconpharma
6/16/2022	Tranxene	Clorazepate Dipotassium	Recordati	Novitium Pharma
6/21/2022	Bicnu	Carmustine	Avet Lifesciences	Ingenus Pharms
6/21/2022	Narcan	Naloxone HCl	Emergent	Padagis
6/21/2022	Gleevec	Imatinib Mesylate	Novartis	Qilu Pharm Hainan
6/22/2022	Epiduo Forte	Adapalene / Benzoyl Peroxide	Galderma	Actavis
6/22/2022	Sabril	Vigabatrin	Lundbeck	Amneal
6/22/2022	Carbaglu	Carglumic Acid	Recordati	Navinta
6/22/2022	Tarceva	Erlotinib HCl	Roche	Eugia Pharma
6/23/2022	Jevtana Kit	Cabazitaxel	Sanofi	Breckenridge
6/23/2022	Syprine	Trientine HCl	Bausch	Hetero Lab
6/24/2022	Amoxil	Amoxicillin	US Antibiotics	Micro Labs
6/24/2022	Yonsa	Abiraterone Acetate	Sunovion	Teva
6/24/2022	Timoptic-XE	Timolol Maleate	Bausch	Gland Pharma
6/24/2022	Sabril	Vigabatrin	Lundbeck	Elite Labs
6/24/2022	Sinequan	Doxepin HCl	Pfizer	MSN
6/24/2022	Nexium 24 Hr	Esomeprazole Magnesium	AstraZeneca	Graviti Pharms
6/27/2022	Amitiza	Lubiprostone	Sucampo	Par / Anchen
6/27/2022	Parnate	Tranylcypromine Sulfate	Concordia	CrossMedika
6/27/2022	Gastrografin	Diatrizoate Meglumine / Diatrizoate Sodium	Bracco	Guardian Drug
6/28/2022	Nimbex	Cisatracurium Besylate	AbbVie	Hikma
6/28/2022	Mysoline	Primidone	Bausch	Rubicon
6/29/2022	Invega	Paliperidone	Johnson & Johnson	Lupin
6/29/2022	Vimpat	Lacosamide	UCB	Zydus
6/29/2022	Epaned O.S.	Enalapril Maleate	Azurity	Amneal
6/29/2022	PlasmaLyte	Multiple Electrolytes Injection Type 1 USP Ph 5.5	Baxter	Fresenius Kabi