ANDA Approvals

Winter 2020

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
10/2/2019 Methadone HCl Methadone HCl N/A Pharm Assoc
10/2/2019 Temovate Clobetasol Propionate Fougera Aleor Dermaceuticals
10/2/2019 Temovate Clobetasol Propionate Fougera Saptalis Pharms
10/4/2019 Azilect Rasagiline Teva Indoco Remedies
10/4/2019 Gemzar Gemcitabine HCl Eli Lilly Shilpa Medicare
10/4/2019 Ritalin Methylphenidate HCl Novartis Alkem Labs
10/4/2019 Lanoxin Digoxin Hikma Vistapharm
10/7/2019 Cialis Tadalafil Eli Lilly Macleods Pharms
10/7/2019 Welchol Colesevelam HCl Daiichi Sankyo Zydus Pharms
10/7/2019 Zovirax Acyclovir Mylan Square Pharms
10/7/2019 Vibramycin Doxycycline Hyclate Pfizer Changzhou Pharm
10/8/2019 Lyrica Pregabalin Pfizer Hetero Labs
10/9/2019 Lymepak Doxycycline Hyclate Chartwell Pharma Changzhou Pharm
10/9/2019 Anectine / Quelicin Succinylcholine Chloride Sandoz / Hospira Breckenridge
10/11/2019 Diporlene Betamethasone Dipropionate Merck Sharp & Dohme Hi Tech
10/15/2019 Uloric Febuxostat Takeda Hikma
10/15/2019 Narcan Naloxone HCl Adapt Pharma Aurobindo Pharma
10/16/2019 Adcirca Tadalafil Eli Lilly Macleods Pharms
10/16/2019 Zytiga Abiraterone Acetate Johnson and Johnson Glenmark Pharms
10/16/2019 Nexium 24 HR Esomeprazole Magnesium Astra-Zeneca Mylan
10/16/2019 Bloxiverz Neostigmine Methylsulfate Avadel Legacy Pharma Gland Pharma
10/17/2019 Diamox Acetazolamide Teva Novitium Pharma
10/17/2019 Flomax Tamsulosin HCl Sanofi Aventis Anbison Lab
10/17/2019 Xylocaine Lidocaine AstraZeneca Sungen Pharma
10/18/2019 Tygacil Tigecycline Pfizer Xellia Pharms Aps
10/18/2019 Depakote ER Divalproex Sodium AbbVie Lupin Ltd
10/18/2019 Garamycin Gentamicin Sulfate Schering Plough Teligent Pharma
10/18/2019 Allegra Fexofenadine HCl Sanofi Granules India
10/18/2019 Rapamune Sirolimus Pfizer Amneal
10/18/2019 Diamox Acetazolamide Teva Eywa Pharma
10/21/2019 Zomig Zolmitriptan AstraZeneca Orchid Healthcare
10/21/2019 Syprine Trientine HCl Bausch Kadmon Pharms
10/21/2019 Mucinex Guaifenesin Indivior Aurobindo
10/21/2019 Lodosyn Carbidopa Aton Pharma Aurobindo
10/21/2019 Anafril Clomipramine HCl SpecGx Jubilant Cadista
10/21/2019 Embeline Clobetasol Propionate Akorn Aleor Dermaceuticals
10/22/2019 Staxyn Vardenafil HCl Bayer Macleods Pharms
10/22/2019 Enablex Darifenacin Hydrobromide Novartis Alan Labs
10/22/2019 Haldol Haloperidol Decanoate Johnson and Johnson Zydus Pharms
10/22/2019 Rapamune Sirolimus Pfizer Apotex
10/23/2019 Angiomax Bivalirudin Sandoz Shuangcheng
10/23/2019 Ery-Pred Erythromycin Ethylsuccinate Arbor Par Pharm Inc
10/23/2019 Desonide Desonide Perrigo Aleor Dermaceuticals
10/23/2019 Akovaz Ephedrine Sulfate Avadel Legacy Pharma Amneal
10/25/2019 Embeline Clobetasol Propionate Akorn Torrent
10/29/2019 Robinul Glycopyrrolate Hikma Apotex
10/29/2019 Ranexa Ranolazine Gilead Amerigen Pharms
10/30/2019 Ditropan Oxybutynin Chloride Janssen Novast Labs
10/30/2019 Onfi Clobazam Lundbeck Lannett
10/30/2019 Anaprox Naproxen Sodium Atnahs Pharma Sciegen Pharms
10/30/2019 Capoten Captopril Par Seton Pharms
10/30/2019 Actigall Ursodiol Allergan Eywa Pharma
10/31/2019 Nicorette Nicotine Polacrilex Glaxo P and L
10/31/2019 Effexor XR Venlafaxine HCl Wyeth Dexcel Pharma
10/31/2019 Nicorette Nicotine Polacrilex Glaxo P and L
10/31/2019 Nicorette Nicotine Polacrilex Glaxo P and L
10/31/2019 Percocet Oxycodone / Acetaminophen Vintage Granules Pharms
11/01/2019 Ammonia N 13 Ammonia N 13 Feinstein Institute Medical Research University of Texas Southwest Medical Center
11/01/2019 Dotarem Gadoterate Meglumine Guerbet LLC GE Healthcare
11/01/2019 Eryped Erythromycin Ethylsuccinate Arbor Amneal
11/04/2019 Crestor Rosuvastatin Calcium IPR Pharma Zhejiang Yongtai
11/04/2019 Nimbex Cisatracurium Besylate AbbVie Zydus
11/04/2019 Baraclude Entecavir Bristol-Myers Squibb Yaopharma
11/04/2019 Narcan Naloxone HCl Adapt Pharma Aurobindo
11/05/2019 Tarceva Erlotinib HCl Genentech Apotex
11/05/2019 Tarceva Erlotinib HCl Genentech Natco Pharma
11/05/2019 Tarceva Erlotinib HCl Genentech Sun Pharm
11/05/2019 Tarceva Erlotinib HCl Genentech Shilpa Medicare
11/05/2019 Zyflo CR Zileuton Mylan Lupin
11/06/2019 Folvite Folic Acid Wyeth Exela Pharma Scs
11/07/2019 Lipitor Atorvastatin Calcium Pfizer Micro Labs
11/08/2019 Trusopt Dorzolamide HCl Merck Micro Labs
11/08/2019 Epiduo Gel 1% Adapalene / Benzoyl Peroxide Galderma Glenmark
11/14/2019 Hectorol Doxercalciferol Sanofi Sun Pharm
11/14/2019 Celebrex Celecoxib GD Searle Cadila Pharms
11/14/2019 Buspar Buspirone HCl Bristol-Myers Squibb Unichem Labs
11/15/2019 Cubicin Daptomycin Merck Sagent Pharms
11/15/2019 Temovate Clobetasol Propionate Fougera Encube
11/15/2019 Deltasone Prednisone Pharmacia & Upjohn Novitium Pharma
11/18/2019 Caduet Amlodipine Besylate / Atorvastatin Calcium Pfizer Apotex
11/18/2019 Nystatin / Triamcinolone Acetonide Nystatin / Triamcinolone Acetonide N/A Vitruvias Therap
11/18/2019 Cardizem Diltiazem HCl Bausch Edenbridge Pharms
11/18/2019 Camptosar Irinotecan HCl Pfizer Gland Pharma
11/20/2019 Lexiva Fosamprenavir Calcium ViiV Sun Pharm
11/20/2019 Apriso Mesalamine Salix Mylan
11/20/2019 Desonide Desonide Perrigo Zydus
11/20/2019 Exjade Deferasirox Novartis Sun Pharm
11/20/2019 Exjade Deferasirox Novartis MSN
11/20/2019 Exjade Deferasirox Novartis Alembic Pharms
11/20/2019 Exjade Deferasirox Novartis Alkem Labs Ltd
11/20/2019 Exjade Deferasirox Novartis Bionpharma
11/20/2019 Jadenu Deferasirox Novartis MSN
11/20/2019 Jadenu Deferasirox Novartis Zydus Pharms
11/20/2019 Jadenu Deferasirox Novartis Alembic Pharms
11/20/2019 Isordil Isosorbide Dinitrate Bausch Zydus
11/21/2019 Faslodex Fulvestrant AstraZeneca HBT Labs
11/21/2019 Tenormin Atenolol Alvogen Malta Unichem Labs
11/22/2019 Rapaflo Silodosin Allergan Alembic Pharms
11/22/2019 Evekeo Amphetamine Sulfate Arbor Bionpharma
11/22/2019 Butalbital / Acetaminophen Butalbital / Acetaminophen Mayne Pharma Granules Pharms
11/25/2019 Exjade Deferasirox Novartis Teva
11/25/2019 Isopto Carpine Pilocarpine HCl Novartis Somerset Therapeutics
11/25/2019 Leustatin Cladribine Janssen Hisun Pharm Hangzhou
11/25/2019 Glumetza Metformin HCl Bausch Glenmark
11/26/2019 Exelon Rivastigmine Novartis Breckenridge
11/26/2019 Amicar Aminocaproic Acid Clover Pharma Amneal
11/26/2019 Lidex Fluocinonide County Line Chemo Research
11/27/2019 Celebrex Celecoxib GD Searle Umedica Labs
11/27/2019 Revatio Sildenafil Citrate Pfizer Amneal
11/27/2019 Parafon Forte Chlorzoxazone Janssen Novitium Pharma
11/27/2019 Revatio Sildenafil Citrate Pfizer Alkem Labs
11/27/2019 Revatio Sildenafil Citrate Pfizer Ajanta Pharma
11/29/2019 Lyrica Pregabalin Pfizer Sun Pharm
11/29/2019 Lovenox Enoxaparin Sodium Sanofi Nanjing King-Friend
11/29/2019 Nitropress Sodium Nitroprusside AbbVie Caplin
11/29/2019 Kenalog Triamcinolone Acetonide Mylan Encube
12/02/2019 Carafate Sucralfate Allergan Amneal
12/02/2019 Sterile Water For Injection Sterile Water For Injection Hospira Medefil
12/03/2019 Solodyn ER Minocycline HCl Bausch Sun Pharm
12/03/2019 Zipsor Diclofenac Potassium Assertio Therapeutics Strides Pharma
12/03/2019 Neurontin Gabapentin Parke Davis Vistapharm
12/03/2019 Sabril Vigabatrin Lundbeck Invagen Pharms
12/04/2019 Gilenya Fingolimod HCl Novartis Hec Pharm
12/04/2019 Gilenya Fingolimod HCl Novartis Biocon
12/04/2019 Gilenya Fingolimod HCl Novartis Sun Pharm
12/04/2019 Precedex Dexmedetomidine HCl Hospira Slayback Pharma
12/09/2019 Rilutek Riluzole Covis Standard Chem Pharm
12/09/2019 Afinitor Everolimus Novartis Par
12/09/2019 Sotradecol Sodium Tetradecyl Sulfate AH Robins Custopharm
12/09/2019 Afinitor Everolimus Novartis Teva
12/10/2019 Unipen Nafcillin Sodium Wyeth Fresenius Kabi
12/11/2019 Fluorouracil Fluorouracil Spectrum Pharma Ingenus Pharms
12/11/2019 NuvaRing Etonogestrel / Ethinyl Estradiol Organon Amneal
12/11/2019 Vesicare Solifenacin Succinate Astellas Cspc Ouyi
12/11/2019 Zithromax Azithromycin Pfizer Taro
12/11/2019 Adderall XR Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate Shire SunGen Pharma
12/12/2019 Mydriacyl Tropicamide Alcon Labs Somerset Therapeutics
12/12/2019 Primaxin Imipenem / Cilastatin Merck Hq Specialty Pharma
12/12/2019 Fluorouracil Fluorouracil Spectrum Pharma Ingenus Pharms
12/12/2019 Bumex Bumetanide Validus Pharma Ceyone
12/13/2019 Jadenu Deferasirox Novartis Actavis
12/13/2019 Myfortic Mycophenolic Acid Novartis Concord Biotech
12/13/2019 Levo-Dromoran Levorphanol Tartrate Valeant Pharma Specgx
12/13/2019 Capoten Captopril Par Ajanta Pharma
12/16/2019 Zyflo CR Zileuton Mylan Par
12/16/2019 Cafcit Caffeine Citrate Hikma Micro Labs
12/17/2019 Ditropoan XL Oxybutynin Chloride Janssen Bionpharma
12/17/2019 Butalbital / Acetaminophen / Caffeine Butalbital / Acetaminophen / Caffeine Nexgen Pharma Mayne Pharma
12/17/2019 Tikosyn Dofetilide Pfizer Prinston
12/17/2019 Butalbital / Acetaminophen / Caffeine Butalbital / Acetaminophen / Caffeine Nexgen Pharma Lannett
12/17/2019 Butalbital / Acetaminophen / Caffeine Butalbital / Acetaminophen / Caffeine Mayne Pharma Lannett
12/18/2019 Diprolene Betamethasone Dipropionate Merck Lupin
12/19/2019 Solodyn ER Minocycline HCl Bausch Alkem Labs
12/19/2019 Entereg Alvimopan Merck Teva
12/20/2019 Travatan Travoprost Novartis Alembic Pharms
12/20/2019 Proglycem Diazoxide Teva E5 Pharma
12/20/2019 Dextrose / Sodium Chloride in Plastic Container Dextrose / Sodium Chloride in Plastic Container Baxter Healthcare Fresenius Kabi
12/23/2019 Eliquis Apixaban Bristol-Myers Squibb Micro Labs
12/23/2019 Eliquis Apixaban Bristol-Myers Squibb Mylan
12/23/2019 Claritin Loratadine Bayer Granules
12/23/2019 Cuprimine Penicillamine Mylan Par
12/23/2019 Cytarabine Cytarabine Teva Gland Pharma
12/26/2019 Tobi Tobramycin Novartis Sun Pharm
12/26/2019 Lyrica Pregabalin Pfizer Cspc Ouyi
12/26/2019 Geodon Ziprasidone Mesylate Pfizer Gland Pharma
12/26/2019 Valium Diazepam Hoffman La Roche Beloteca
12/26/2019 Abilify Aripiprazole Bristol-Myers Squibb Vistapharm
12/27/2019 Myrbetriq Mirabegron Astellas Sawai
12/27/2019 Jadenu Deferasirox Novartis Amneal
12/27/2019 Tikosyn Dofetilide Pfizer Riconpharma
12/30/2019 Uloric Febuxostat Takeda Indoco Remedies
12/30/2019 Uloric Febuxostat Takeda MSN
12/30/2019 Detrol Tolterodine Tartrate Pfizer Invatech
12/30/2019 Cormax Clobetasol Propionate Akorn Torrent
12/30/2019 Marcaine Bupivacaine HCl Hospira Huons
12/30/2019 Jadenu Deferasirox Novartis Piramal
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