ANDA Approvals

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

Third 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
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

Oren D. Langer

Partner

Managing Partner, New York Office

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