ANDA Approvals

Winter 2020

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