ANDA Approvals

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

Second 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
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

Oren D. Langer

Partner

Managing Partner, New York Office

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