ANDA Approvals

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

First 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
01/03/2022 Esbriet Pirfenidone Genentech Amneal
01/03/2022 Doryx Doxycycline Hyclate Mayne Alembic Pharms
01/03/2022 Rapaflo Silodosin AbbVie Upsher Smith
01/04/2022 Vesicare Solifenacin Succinate Astellas Accord Healthcare
01/04/2022 Rapaflo Silodosin AbbVie Prinston
01/04/2022 Toprol XL Metoprolol Succinate AstraZeneca Prinston
01/04/2022 Comtan Entacapone Orion Alembic Pharms
01/04/2022 Migranal Dihydroergotamine Mesylate Bausch Amneal
01/04/2022 Effexor ER Venlafaxine HCl Wyeth Pharmadax
01/05/2022 Tamiflu Oseltamivir Phosphate Roche Sunshine
01/05/2022 Progesterone Progesterone Actavis Xiromed
01/05/2022 Zytiga Abiraterone Acetate Johnson & Johnson Oncogen Pharma
01/06/2022 Colcrys Colchicine Takeda Aurobindo
01/07/2022 Pepcid Famotidine Bausch VKT
01/10/2022 Transderm Scop Scopolamine Baxter Healthcare Actavis Labs
01/11/2022 Trileptal Oxcarbazepine Novartis Annora Pharma
01/12/2022 Morphine Sulfate Morphine Sulfate Hikma Mayne Pharma
01/13/2022 Tamiflu Oseltamivir Phosphate Roche Strides
01/13/2022 Potassium Chloride Potassium Chloride Genus Rubicon
01/14/2022 Differin Adapalene Galderma Taro Pharms
01/18/2022 Amitiza Lubiprostone Sucampo Teva
01/18/2022 Cleocin T Clindamycin Phosphate Pfizer Encube
01/19/2022 Kenalog 40 Triamcinolone Acetonide Apothecon Custopharm / Long Grove Pharms
01/19/2022 Ranexa Ranolazine Gilead VKT Pharma
01/19/2022 Floxin Otic Ofloxacin Daiichi Sankyo FDC
01/19/2022 Sabril Vigabatrin Lundbeck Zydus
01/20/2022 Esbriet Pirfenidone Genentech Accord Healthcare
01/21/2022 Welchol Colesevelam HCl Daiichi Sankyo SPH
01/21/2022 Depo Medrol Methylprednisolone Acetate Pfizer Par
01/21/2022 Questran Cholestyramine Bristol-Myers Squib Upsher Smith
01/24/2022 Atripla Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Hetero Labs
01/24/2022 Fosrenol Lanthanum Carbonate Takeda Invagen Pharms
01/24/2022 Hectorol Doxercalciferol Genzyme Aurobindo / Eugia Pharma
01/25/2022 Hygroton Chlorthalidone Sanofi Aventis Sunny
01/25/2022 Cellcept Mycophenolate Mofetil Roche Teva
01/25/2022 Esbriet Pirfenidone Genentech Accord Healthcare
01/25/2022 Esbriet Pirfenidone Genentech Teva
01/25/2022 Stalevo Carbidopa / Levodopa / Entacapone Orion Rising
01/25/2022 Lioresal Baclofen Novartis Mankind Pharma
01/25/2022 Cosopt Dorzolamide HCl / Timolol Maleate Akorn Micro Labs
01/26/2022 Pomalyst Pomalidomide Celgene Mylan
01/26/2022 Monurol Fosfomycin Tromethamine AbbVie Cipla
01/26/2022 Aloprim Allopurinol Mylan Gland Pharma
01/26/2022 Potassium Chloride Potassium Chloride Genus Tris Pharma
01/26/2022 Fioricet with codeine Butalbital / Acetaminophen / Caffeine / Codeine Phosphate Teva Hikma
01/26/2022 Atropine sulfate Atropine Sulfate Hospira Amneal
01/26/2022 Ziac Bisoprolol Fumarate / Hydrochlorothiazide Teva Glenmark
01/27/2022 Fosrenol Lanthanum Carbonate Takeda Barr
01/27/2022 Sovaldi Sofosbuvir Gilead Teva
01/27/2022 Lasix Furosemide Sanofi Aventis Hong Kong
01/27/2022 Klor-con Potassium Chloride Upsher-Smith Granules
01/27/2022 Chlorpromazine HCl Chlorpromazine HCl Upsher-Smith MSN Labs
01/27/2022 Hemabate Carboprost Tromethamine Pfizer Amneal
01/27/2022 Trusopt Dorzolamide HCl Merck Gland Pharma
01/27/2022 Metrogel-Vaginal Metronidazole Bausch Glenmark
01/28/2022 Zioptan Tafluprost Akorn Sandoz
01/28/2022 Cystadane Betaine Recordati Lukare Medical
01/28/2022 Pepcid AC Famotidine Johnson & Johnson Vkt Pharma
01/31/2022 Qoliana / Alphagan P Brimonidine Tartrate Sandoz / Allergan Apotex
01/31/2022 Biaxin Clarithromycin AbbVie Alembic Pharms
01/31/2022 Adderall XR Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate Takeda Teva
02/01/2022 Mucinex D Guaifenesin / Pseudoephedrine HCl Reckitt Padagis
02/02/2022 Restasis Cyclosporine AbbVie Mylan
02/02/2022 Excedrin Migraine Acetaminophen / Aspirin / Caffeine Glaxo Aurobindo 
02/02/2022 Limbitrol Chlordiazepoxide / Amitriptyline HCl Heritage Micro Labs
02/02/2022 Reyataz Atazanavir Sulfate Bristol-Myers Squib Hetero Labs
02/02/2022 Wellbutrin XL Bupropion HCl Bausch Granules
02/03/2022 Zavesca Miglustat Actelion Breckenridge
02/03/2022 Vidaza Azacitidine Celgene Amneal
02/03/2022 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Novast Labs
02/03/2022 Acetadote Acetylcysteine Cumberland Aspen
02/03/2022 Lamictal ODT Lamotrigine Glaxo Amring Pharms
02/04/2022 Aczone 7.5% gel Dapsone Almirall Mylan
02/04/2022 Noxafil Posaconazole Merck Biocon Pharma
02/07/2022 Selzentry Maraviroc ViiV Hetero Labs
02/07/2022 Brovana Arformoterol Tartrate Mylan Lupin
02/07/2022 Renvela Sevelamer Carbonate Sanofi Micro Labs
02/07/2022 Morphine Sulfate Morphine Sulfate Hikma Riconpharma
02/07/2022 Anectine / Quelicin Succinylcholine Chloride Sandoz / Hospira Be Pharms
02/08/2022 Amitiza Lubiprostone Sucampo Dr Reddys Labs
02/08/2022 Revex Nalmefene HCl Eurohealth Purdue Pharma
02/08/2022 Bactrim Sulfamethoxazole / Trimethoprim Sun Pharma Novitium Pharma
02/08/2022 Revatio Sildenafil Citrate Viatris MSN Labs
02/08/2022 Lanoxin Digoxin Advanz Aurobindo
02/09/2022 Chlorthalidone Chlorthalidone Mylan Inventia
02/09/2022 Sinequan Doxepin HCl Pfizer Mankind Pharma
02/10/2022 Daliresp Roflumilast AstraZeneca Zydus
02/10/2022 Veltin gel Clindamycin Phosphate / Tretinoin Almirall Solaris Pharma
02/10/2022 Faslodex Fulvestrant AstraZeneca Jiangsu Hansoh Pharm
02/10/2022 Aczone 7.5% gel Dapsone Almirall Torrent
02/10/2022 Nexium IV Esomeprazole Sodium AstraZeneca Hainan Poly
02/11/2022 Tobradex Tobramycin / Dexamethasone Novartis Padagis
02/14/2022 Erythrocin Erythromycin Lactobionate Hospira Nexus Pharms
02/15/2022 Samsca Tolvaptan Otsuka Par
02/15/2022 Vancomycin HCl Vancomycin HCl Baxter Knack
02/16/2022 Sanctura Trospium Chloride Allergan Amici
02/17/2022 Antivert Meclizine HCl Casper Cipla
02/17/2022 Valcyte Valganciclovir HCl Roche Airis Pharma
02/17/2022 Embeline Clobetasol Propionate Akorn Solaris Pharma
02/18/2022 Macrobid Nitrofurantoin Monohydrate / Macrocrystals Almatica Inventia
02/18/2022 Symmetrel Amantadine HCl Endo Strides
02/18/2022 Lyrica Pregabalin Pfizer Invatech
02/18/2022 Cardioplegic / Plegisol Cardioplegic / Plegisol Hospira Fresenius Kabi USA
02/18/2022 Betamethasone Dipropionate Betamethasone Dipropionate Fougera Pharms Tasman Pharma
02/18/2022 Testred Methyltestosterone Bausch Novitium Pharma
02/22/2022 Farxiga Dapagliflozin AstraZeneca Zydus
02/22/2022 Fortamet Metformin HCl Teva Sciegen Pharms
02/23/2022 Apokyn Apomorphine HCl Supernus Sage Chems
02/23/2022 Jadenu Sprinkle Deferasirox Novartis Cipla
02/23/2022 Acetadote Acetylcysteine Cumberland Indoco
02/23/2022 Maxzide Triamterene / Hydrochlorothiazide Mylan Rubicon
02/24/2022 Chlorthalidone Chlorthalidone Mylan Tagi
02/24/2022 Epaned Enalapril Maleate Azurity Annora Pharma
02/25/2022 Depakote ER Divalproex Sodium AbbVie Unichem
02/25/2022 Akovaz Ephedrine Sulfate Exela Gland Pharma
02/28/2022 Cytarabine Cytarabine Teva Hong Kong
02/28/2022 Tamiflu Oseltamivir Phosphate Roche Leading Pharma
02/28/2022 Navane Thiothixene Pfizer Amneal
03/01/2022 Bonjesta Doxylamine Succinate / Pyridoxine HCl Duchesnay Actavis Labs
03/02/2022 Jublia Efinaconazole Bausch Lupin
03/02/2022 Brovana Arformoterol Tartrate Mylan Vistapharm
03/03/2022 Niaspan Niacin AbbVie Macleods
03/04/2022 Mykacet Nystatin / Triamcinolone Acetonide Cosette Aleor Dermaceuticals
03/04/2022 Cambia Diclofenac Potassium Assertio Annora Pharma
03/07/2022 Zyloprim Allopurinol Casper Harman Finochem
03/08/2022 Nitrostat Nitroglycerin Viatris Zydus
03/08/2022 Lyrica Pregabalin Pfizer Eskayef
03/10/2022 Colcrys Colchicine Takeda Strides
03/10/2022 Sabril Vigabatrin Lundbeck Lupin
03/10/2022 Nilstat Nystatin Glenmark Medley
03/10/2022 Colestid Colestipol HCl Pfizer Zydus
03/11/2022 Nimbex Cisatracurium Besylate AbbVie Piramal Healthcare
03/11/2022 Digoxin Digoxin Hikma Amici
03/14/2022 Daytrana Methylphenidate Noven Mylan
03/14/2022 Sinequan Doxepin HCl Pfizer Jubilant Cadista
03/15/2022 Breyna Budesonide / Formoterol Fumarate Dihydrate AstraZeneca Mylan
03/15/2022 Carafate Sucralfate AbbVie Vistapharm
03/15/2022 Cardura Doxazosin Mesylate Viatris Method
03/15/2022 Bystolic Nebivolol HCl AbbVie Unichem
03/15/2022 Mucinex Guaifenesin Reckitt Benckiser Dr Reddys Labs
03/17/2022 Vimpat Lacosamide UCB Hetero Labs
03/17/2022 Vimpat Lacosamide UCB Amneal
03/17/2022 Vimpat Lacosamide UCB MSM Labs
03/17/2022 Vimpat Lacosamide UCB Alembic
03/17/2022 Vimpat Lacosamide UCB Glenmark
03/17/2022 Vimpat Lacosamide UCB Sun Pharm
03/17/2022 Vimpat Lacosamide UCB Sciegen Pharms
03/17/2022 Pentam Pentamidine Isethionate Fresenius Kabi Xgen Pharms
03/17/2022 Vimpat Lacosamide UCB Indoco
03/17/2022 Isoptin Verapamil HCl Mt Adams Technologies Acic Pharms
03/18/2022 Xibrom Bromfenac Sodium Bausch Eugia Pharma
03/21/2022 Sklice Ivermectin Arbor Teva
03/21/2022 Kaletra Lopinavir / Ritonavir AbbVie Laurus
03/21/2022 Brevibloc Esmolol HCl Baxter Eugia Pharma
03/22/2022 Lyrica CR Pregabalin Pfizer Rubicon
03/23/2022 Revatio Sildenafil Citrate Viatris Lupin
03/23/2022 Inspra Eplerenone Pfizer Kartha
03/23/2022 Amicar Aminocaproic Acid Akorn Agenix
03/23/2022 Toradol Ketorolac Tromethamine Roche Havix (Senores)
03/23/2022 Laying-O-Jet Kit Lidocaine HCl Amphastar Novitium Pharma
03/24/2022 Klor-con Potassium Chloride Upsher-Smith Rubicon
03/24/2022 Onfi Clobazam Lundbeck Aurobindo
03/25/2022 Esbriet Pirfenidone Genentech Amneal
03/25/2022 Butalbital / Acetaminophen / Caffeine Butalbital / Acetaminophen / Caffeine Gilbert Hikma
03/28/2022 Uloric Febuxostat Takeda Prinston
03/28/2022 Keppra Levetiracetam UCB Prinston
03/28/2022 Tamiflu Oseltamivir Phosphate Roche Hetero Labs
03/28/2022 Dextrose 5% and Lactated Ringer's Dextrose 5% and Lactated Ringer's ICU Medical Fresenius Kabi USA
03/28/2022 Prednisone Prednisone Hikma Aurobindo
03/29/2022 Procardia XL Nifedipine Pfizer Alkem Labs
03/29/2022 Prozac Fluoxetine HCl Eli Lilly Micro Labs
03/30/2022 Sodium Phosphates Sodium Phosphates Hospira Fresenius Kabi USA
03/30/2022 Lymepak Doxycycline Hyclate Chartwell Praxgen
03/30/2022 Epaned O.S. Enalapril Maleate Azurity Alkem Labs
03/30/2022 Datscan Ioflupane I-123 GE Healthcare Curium
03/30/2022 Motrin Ibuprofen McNeil Yichang Humanwell
03/31/2022 Aczone Dapsone AbbVie SeegPharm
03/31/2022 Bystolic Nebivolol HCl AbbVie Ajanta
03/31/2022 Vimpat Lacosamide UCB Alkem Labs
03/31/2022 Tegretol XR Carbamazepine Novartis Zhejiang Jiuzhou
03/31/2022 Zovirax Acyclovir Mylan Aurobindo

Oren D. Langer

Partner

Managing Partner, New York Office

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