ANDA Approvals Winter 2017 | Hatch-Waxman | Robins Kaplan LLP Law Firm

Winter 2017

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
10/3/2017	DDAVP	Desmopressin Acetate	Ferring	Zydus Pharms
10/3/2017	Copaxone	Glatiramer Acetate	Teva	Mylan
10/3/2017	Toviaz	Fesoterodine Fumarate	Pfizer	Zydus Pharms
10/3/2017	Copaxone	Glatiramer Acetate	Teva	Mylan
10/3/2017	Micardis	Telmisartan	Boehringer Ingelheim	Micro Labs
10/4/2017	Avodart	Dutasteride	GlaxoSmithKline	Zydus Pharms
10/4/2017	Vigamox	Moxifloxacin HCl	Novartis	Aurobindo
10/5/2017	Effexor XR	Venlafaxine HCl	Wyeth	MacLeods
10/5/2017	Corgard	Nadolol	US Worldmeds	Lupin
10/6/2017	Actos	Pioglitazone HCl	Takeda	Puracap Pharm
10/6/2017	Viramune XR	Nevirapine	Boehringer Ingelheim	MacLeods
10/6/2017	Acticlate	Doxycyline Hyclate	Aqua Pharms	Amneal
10/10/2017	Nuedexta	Dextromethorphan Hydrobromide / Quinidine Sulfate	Avanir Pharms	Actavis
10/10/2017	Cleocin	Clindamycin Phosphate	Pharmacia and Upjohn	Mylan
10/10/2017	Cleocin	Clindamycin Phosphate	Pharmacia and Upjohn	Mylan
10/10/2017	Baraclude	Entecavir	Bristol Myers Squibb	Prinston
10/11/2017	Pristiq	Desvenlafaxine Succinate	Wyeth	Zydus Pharms
10/11/2017	Mepron	Atovaquone	GlaxoSmithKline	Apotex
10/12/2017	Emend	Aprepitant	Merck	Glenmark
10/12/2017	Zyloprim	Allopurinol	Casper Pharma	Zydus Pharms
10/13/2017	Gabitril	Tiagabine HCl	Cephalon	Wilshire Pharms
10/13/2017	Avodart	Dutasteride	GlaxoSmithKline	Haupt Pharma
10/13/2017	Tobi	Tobramycin	Novartis	Mylan
10/16/2017	Nitrostat	Nitroglycerin	Pfizer	Actavis
10/16/2017	Effient	Prasugrel	Eli Lilly and Co	Liberty Pharma
10/16/2017	Effient	Prasugrel	Eli Lilly and Co	Aurobindo
10/16/2017	Effient	Prasugrel	Eli Lilly and Co	Panacea Biotec
10/16/2017	Zemplar	Paricalcitol	AbbVie	Akorn
10/16/2017	Gastrocrom	Cromolyn Sodium	Mylan	Ailex Pharms
10/16/2017	Nexium 24Hr (OTC)	Esomeprazole Magnesium (OTC)	AstraZeneca	Aurobindo
10/16/2017	Aczone	Dapsone	Allergan	Taro
10/17/2017	Ancobon	Flucytosine	Valeant	West-Ward
10/18/2017	Bumex	Bumetanide	Validus Pharms	Amneal
10/20/2017	Lodosyn	Carbidopa	Aton	Novel Labs
10/20/2017	Prometrium	Progesterone	Virtus Pharms	Sandoz
10/20/2017	Nexium	Esomeprazole Magnesium	AstraZeneca	Alkem Labs
10/23/2017	Renvela	Sevelamer Carbonate	Genzyme	Impax Labs
10/23/2017	Kapvay	Clonidine HCl	Concordia Pharms	Lupin
10/23/2017	Klor-Con	Potassium Chloride	Pharma Res Software	Upsher-Smith Labs
10/25/2017	Coreg CR	Carvedilol Phosphate	SmithKline Beecham	Sun Pharm Industries
10/25/2017	Nexterone	Amiodarone HCl	Baxter Healthcare	Aurobindo
10/25/2017	Levetiracetam in Sodium Chloride	Levetiracetam in Sodium Chloride	HQ Specialty Pharma	Gland Pharma
10/26/2017	Neurontin	Gabapentin	Pfizer	Jiangsu Hengrui Med
10/26/2017	Renvela	Sevelamer Carbonate	Genzyme	Invagen Pharms
10/26/2017	Neurontin	Gabapentin	Pfizer	CSPC Ouyi Pharm
10/27/2017	Reclast	Zoledronic Acid	Novartis	Mylan
10/27/2017	Methadone HCl	Methadone HCl	Mylan	Akorn
10/27/2017	Clobex	Clobetasol Propionate	Galderma Labs	Hi-Tech Pharmacal
10/27/2017	Zometa	Zoledronic Acid	Novartis	Cipla
10/27/2017	Dilaudid	Hydromorphone HCl	Rhodes	Ascent Pharms
10/30/2017	Azilect	Rasagiline Mesylate	Teva	Alkem Labs
10/30/2017	Xylocaine	Lidocaine HCl	Fresenius Kabi USA	Aurobindo
10/30/2017	Allegra-D	Fexofenadine HCl / Pseudoephedrine HCl (OTC)	Sanofi Aventis	Aurobindo
10/31/2017	Acetadote	Acetylcysteine	Cumberland Pharms	Sagent Pharms
10/31/2017	Glucophage	Metformin HCl	Bristol Myers Squibb	MacLeods
10/31/2017	Dexedrine	Dextroamphetamine Sulfate	Impax Labs	Vintage Pharms
10/31/2017	Boniva	Ibandronate Sodium	Hoffmann La Roche	MacLeods
10/31/2017	Tamiflu	Oseltamivir Phosphate	Roche	Alvogen Pine Brook
11/2/2017	Zemplar	Paricalcitol	AbbVie	Mylan
11/2/2017	Azor	Amlodipine / Olmesartan Medoxomil	Daiichi Sankyo	Micro Labs
11/3/2017	Wellbutrin XL	Bupropion HCl	Valeant	TWi
11/6/2017	Hyzaar	Losartan Potassium / Hydrochlorothiazide	Merck Sharp Dohme	Prinston
11/6/2017	Clolar	Clofarabine	Genzyme	Dr Reddys Labs
11/6/2017	Integrilin	Eptifibatide	Schering	Accord Healthcare
11/6/2017	Clolar	Clofarabine	Genzyme	Amneal
11/6/2017	Clolar	Clofarabine	Genzyme	Mylan
11/6/2017	Micardis HCT	Telmisartan / Hydrochlorothiazide	Boehringer Ingelheim	Prinston
11/8/2017	Motrin IB (OTC)	Ibuprofen (OTC)	Johnson and Johnson	Aurobindo
11/9/2017	Vigamox	Moxifloxacin HCl	Novartis	Akorn
11/9/2017	Cosmegen	Dactinomycin	Recordati Rare	Mylan
11/9/2017	Diprolene	Betamethasone Dipropionate	Merck Sharp Dohme	Teligent Pharma
11/9/2017	Children's Allegra	Fexofenadine HCl	Sanofi Aventis	Taro Pharm
11/9/2017	Children's Allegra	Fexofenadine HCl	Sanofi Aventis	Taro Pharm
11/9/2017	Oxycodone HCl	Oxycodone HCl	Lehigh Valley / Vistapharm	Ascent Pharms
11/13/2017	Cellcept	Mycophenolate Mofetil	Roche Palo	Zhejiang Hisun Pharm
11/13/2017	Zovirax	Acyclovir	Valeant	G and W Labs
11/13/2017	Zocor	Simvastatin	Merck Sharp Dohme	Hisun Pharm Hangzhou
11/13/2017	Zantac 150 (OTC)	Ranitidine HCl (OTC)	Sanofi	Aurobindo
11/13/2017	Zantac 75 (OTC)	Ranitidine HCl (OTC)	Sanofi	Aurobindo
11/14/2017	Eloxatin	Oxaliplatin	Sanofi Aventis / Teva	Mylan
11/16/2017	Solodyn	Minocycline HCl	Medicis	Zydus Pharms
11/16/2017	Cellcept	Mycophenolate Mofetil	Roche Palo	Zhejiang Hisun Pharm
11/16/2017	Lotrimin Ultra (OTC)	Butenafine HCl (OTC)	Bayer Healthcare	Taro
11/16/2017	Intuniv	Guanfacine HCl	Shire	Sun Pharm Inds
11/16/2017	Pulmicort	Budesonide	AstraZeneca	Cipla
11/16/2017	Dacogen	Decitabine	Otsuka	Cipla
11/16/2017	Fluoxetine HCl	Fluoxetine HCl	Alvogen	Par
11/17/2017	Cytovene	Ganciclovir	Roche Palo	Mylan
11/17/2017	Loestrin 24 Fe	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	Apil	Glenmark
11/17/2017	Abstral	Fentanyl Citrate	Sentynl Theraps	Actavis
11/17/2017	Edecrin	Ethacrynate Sodium	Aton	Zydus Pharms
11/20/2017	Choline C-11	Choline C-11	MCPRF	UCSF Rodiopharm
11/20/2017	Busulfex	Myleran	Otsuka	Aspen Global
11/20/2017	Focalin	Dexmethylphenidate HCl	Novartis	Rhodes
11/20/2017	Kapvay	Clonidine HCl	Concordia Pharms	Ajanta
11/20/2017	Fluoxetine HCl	Fluoxetine HCl	Alvogen	Inventia Healthcare
11/20/2017	Kapvay	Clonidine HCl	Concordia Pharms	Xiamen LP Pharm
11/20/2017	Kapvay	Clonidine HCl	Concordia Pharms	Amneal
11/21/2017	Ziagen	Abacavir Sulfate	VIIV Healthcare	Cipla
11/21/2017	Prezista	Darunavir Ethanolate	Janssen	Teva
11/21/2017	Loestrin Fe 1/20	Hailey Fe 1/20	Apil	Glenmark
11/21/2017	Vytorin	Ezetimibe and Simvastatin	Merck Sharp Dohme	Amneal
11/21/2017	Locoid	Hydrocortisone Butyrate	Precision Dermat	Teligent Pharma
11/21/2017	Avodart	Dutasteride	GlaxoSmithKline	Humanwell Puracap
11/22/2017	Angiomax	Bivalirudin	The Medicines Co	Accord Healthcare
11/22/2017	Crestor	Rosuvastatin Calcium	IPR	MSN Labs
11/24/2017	Robaxin	Methocarbamol	West-Ward	Navinta
11/24/2017	Topotecan HCl	Topotecan Hydrochloride	Hospira	Mylan
11/24/2017	Trokendi XR	Topiramate	Supernus Pharms	Zydus Pharms
11/24/2017	Bacteriostatic Water for Injection in Plastic Container / Sterile Water for Injection in Plastic Container	Bacteriostatic Water for Injection in Plastic Container / Sterile Water for Injection in Plastic Container	Hospira / B Braun & Baxter Healthcare & Hospira & ICU Medical	Fresenius Kabi USA
11/27/2017	Capastat Sulfate	Capreomycin Sulfate	Akorn	Mylan
11/27/2017	Atacand HCT	Candesartan Cilexetil and Hydrochlorothiazide	AstraZeneca	Zydus Pharms
11/27/2017	Xeloda	Capecitabine	Hoffmann La Roche	Alkem Labs
11/27/2017	Biltricide	Praziquantel	Bayer Healthcare	Par
11/28/2017	Depo-Provera	Medroxyprogesterone Acetate	Pharmacia and Upjohn	Amphastar Pharms
11/28/2017	Depo-Provera	Medroxyprogesterone Acetate	Pharmacia and Upjohn	Amphastar Pharms
11/28/2017	Precedex	Dexmedetomidine Hydrochloride	Hospira	Teva
11/28/2017	Renvela	Sevelamer Carbonate	Genzyme	Amneal
11/29/2017	Seroquel XR	Quetiapine Fumarate	AstraZeneca	MacLeods
11/29/2017	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Accord Healthcare
11/29/2017	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Aurobindo
11/29/2017	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Novast Labs
11/29/2017	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Sciegen Pharms
11/30/2017	Remodulin	Treprostinil	United Therap	Sandoz
11/30/2017	Zantac 150 / Zantac 300	Ranitidine Hydrochloride	Glaxo Grp	Acic Pharms
11/30/2017	Heparin Sodium	Heparin Sodium	Fresenius Kabi USA & West-Ward	Mylan
11/30/2017	Heparin Sodium	Heparin Sodium	Fresenius Kabi USA	Mylan
11/30/2017	Prograf	Tacrolimus	Astellas	Belcher Pharms
12/1/2017	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Anchen Pharms
12/1/2017	Megace ES	Megestrol Acetate	Endo	Breckenridge
12/1/2017	Advil Cold and Sinus (OTC)	Ibuprofen and Pseudoephedrine Hydrochloride (OTC)	Pfizer	Aurobindo
12/4/2017	Abilify	Aripiprazole	Otsuka	Prinston
12/5/2017	Pataday	Olopatadine Hydrochloride	Novartis	Apotex
12/5/2017	Pataday	Olopatadine Hydrochloride	Novartis	Akorn
12/5/2017	Pataday	Olopatadine Hydrochloride	Novartis	Cipla
12/6/2017	Zyvox	Linezolid	Pharmacia and Upjohn	Mylan
12/6/2017	Gemcitabine HCl	Gemcitabine HCl	Hospira	Mylan
12/6/2017	Magnesium Sulfate in Plastic Container	Magnesium Sulfate in Plastic Container	Hospira	HQ Specialty Pharma
12/6/2017	Diclegis	Doxylamine Succinate and Pyridoxine Hydrochloride	Duchesnay	Par
12/6/2017	Clozaril	Clozapine	Heritage Life	Zydus Pharms
12/6/2017	Clolar	Clofarabine	Genzyme	MSN Labs
12/8/2017	Melphalan HCl	Melphalan HCl	Dr Reddys Labs	Dr Reddys Labs
12/8/2017	Locoid Lipocream	Hydrocortisone Butyrate	Precision Dermat	Actavis
12/8/2017	Busulfex	Busulfan	Otsuka	Actavis
12/8/2017	Cytovene	Ganciclovir Sodium	Roche Palo	Pharmascience
12/8/2017	Enablex	Darifenacin Hydrobromide	Apil	Alembic
12/8/2017	Gabitril	Tiagabine Hydrochloride	Cephalon	Amneal
12/8/2017	Reclast	Zoledronic Acid	Novartis	Aurobindo
12/11/2017	Kenalog-40	Triamcinolone Acetonide	Apothecon	Amneal
12/12/2017	Mirapex ER	Pramipexole Dihydrochloride	Boehringer Ingelheim	Zydus Pharms
12/12/2017	Macrodantin	Nitrofurantoin	Alvogen Malta	Zydus Pharms
12/12/2017	Safyral	Tydemy	Bayer Healthcare	Lupin
12/12/2017	Detrol LA	Tolterodine Tartrate	Pharmacia and Upjohn	Hetero Labs
12/12/2017	Valcyte	Valganciclovir Hydrochloride	Hoffmann La Roche	Dr Reddys Labs
12/12/2017	Flagyl	Metronidazole	GD Searle	Cadila Pharms
12/14/2017	Cafcit	Caffeine Citrate	West-Ward	Micro Labs
12/14/2017	Inapsine	Droperidol	Akorn	Eurohealth Intl
12/15/2017	Sustiva	Efavirenz	Bristol Myers Squibb	Aurobindo
12/15/2017	Duac	Clindamycin Phosphate / Benzoyl Peroxide	Stiefel	Taro
12/15/2017	Astepro	Azelastine HCl	Mylan	Amneal
12/18/2017	Mesnex	Mesna	Baxter Healthcare	Gland Pharma
12/18/2017	Xenazine	Tetrabenazine	Valeant	Bionpharma
12/18/2017	Busulfex	Busulfan	Otsuka	Amneal
12/19/2017	Exforge HCT	Amlodipine Besylate / Valsartan / Hydrochlorothiazide	Novartis	Aurobindo
12/19/2017	Procardia XL	Nifedipine	Pfizer	Zydus Pharms
12/21/2017	Advil Liqui-Gels	Ibuprofen (OTC)	Pfizer	Ascent Pharms
12/21/2017	Zetia	Ezetimibe	Merck Sharp Dohme	Alkem Labs
12/22/2017	Melphalan HCl	Melphalan HCl	Dr Reddys Labs	Fresenius Kabi USA
12/22/2017	Ativan	Lorazepam	Valeant Intl	Aurolife Pharma
12/22/2017	Avage / Tazorac	Tazarotene	Allergan	G and W Labs
12/22/2017	Vytorin	Ezetimibe / Simvastatin	Merck Sharp Dohme	Alkem Labs
12/22/2017	Zyrtec	Cetirizine HCl	Johnson and Johnson	Granules India
12/22/2017	Yaz	Drospirenone / Ethinyl Estradiol	Bayer Healthcare	Cyndea Pharma
12/22/2017	Methotrexate Sodium	Methotrexate Sodium	Dava Pharms	Amneal
12/26/2017	Fortamet	Metformin HCl	Andrx Labs	Nostrum Labs
12/26/2017	Norpramin	Desipramine HCl	US Pharm Holdings	Ingenus Pharms
12/26/2017	Arixtra	Fondaparinux Sodium	Mylan	Aurobindo
12/26/2017	Triamcinolone Acetonide	Triamcinolone Acetonide	Mylan	Alkem Labs
12/26/2017	Synalar	Fluocinolone Acetonide	Medimetriks Pharms	Glasshouse Pharms
12/26/2017	Minastrin 24 Fe	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	Apil	Glenmark
12/27/2017	Seasonique	Jaimiess	Teva	Labs Leon Farma
12/27/2017	Anafranil	Clomipramine HCl	Mallinckrodt	Zydus Pharms
12/29/2017	Valtrex	Valacyclovir HCl	GlaxoSmithKline	Zydus Pharms
12/29/2017	Feldene / Piroxicam	Piroxicam	Pfizer / Micro Labs	Micro Labs
12/29/2017	Zometa	Zoledronic Acid	Novartis	BPI Labs
12/29/2017	Mucinex D (OTC)	Guaifenesin, Pseudoephedrine HCl (OTC)	Reckitt Benckiser	Dr Reddys Labs