ANDA Approvals

Winter 2019

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
10/1/2018	Pristiq	Desvenlafaxine Succinate	PF Prism CV	Yichang Humanwell
10/2/2018	Inomax	Noxivent	Mallinckrodt	Praxair Distribution
10/3/2018	Aromasin	Exemestane	Pharmacia and Upjohn	Zydus
10/3/2018	Comtan	Entacapone	Orion Pharma	Sunshine Lake
10/3/2018	Daliresp	Roflumilast	AstraZeneca	Breckenridge
10/3/2018	Methylin	Methylphenidate HCl	Specgx	Wes Pharma
10/3/2018	Minipress	Prazosin HCl	Pfizer	Novitium Pharma
10/3/2018	Mirapex	Pramipexole Dihydrochloride	Boehringer Ingelheim	CSPC Ouyi Pharm
10/4/2018	Olux	Clobetasol Propionate	Mylan	Taro Pharm
10/4/2018	Levophed	Norepinephrine Bitartrate	Hospira	Mylan
10/5/2018	Welchol	Colesevelam HCl	Daiichi Sankyo	Alkem
10/5/2018	Kenalog-40	Triamcinolone Acetonide	Apothecon	Teva
10/5/2018	Welchol	Colesevelam HCl	Daiichi Sankyo	Dr Reddy's Labs
10/9/2018	Latisse	Bimatoprost	Allergan	Hi-Tech Pharmacal
10/9/2018	Zithromax	Azithromycin	Pfizer	Hainan Poly Pharm
10/9/2018	Zemplar	Paricalcitol	AbbVie	Aurobindo
10/9/2018	Tikosyn	Dofetilide	Pfizer	Par
10/9/2018	Zithromax	Azithromycin	Pfizer	Aurobindo
10/9/2018	Focalin XR	Dexmethylphenidate HCl	Novartis	Adare Pharms
10/9/2018	Tikosyn	Dofetilide	Pfizer	Sun
10/9/2018	Suprax	Cefixime	Lupin	Alkem
10/10/2018	Aggrenox	Aspirin / Dipyridamole	Boehringer Ingelheim	Dr Reddy's Labs
10/11/2018	Sensipar	Cinacalcet HCl	Amgen	Sun
10/11/2018	Mepron	Atovaquone	GlaxoSmithKline	Hetero Labs
10/12/2018	Viagra	Sildenafil Citrate	Pfizer	Ajanta
10/12/2018	Omeprazole	Omeprazole (OTC)	Dexcel Pharma	Sun
10/12/2018	Glucophage	Metformin HCl	Bristol-Myers Squibb	Sunshine Lake
10/12/2018	Betamethasone Dipropionate	Betamethasone Dipropionate	Fougera Pharms	G and W Labs
10/12/2018	Depo-Provera	Medroxyprogesterone Acetate	Pharmacia and Upjohn	Mylan
10/12/2018	Kapvay	Clonidine HCl	Concordia Pharms	Upsher-Smith Labs
10/16/2018	Sensipar	Cinacalcet HCl	Amgen	Mylan
10/16/2018	Rilutek	Riluzole	Covis Pharma	Daito Pharms
10/16/2018	Eloxatin	Oxaliplatin	Sanofi Aventis / Teva	Ingenus Pharms
10/16/2018	Crestor	Rosuvastatin Calcium	IPR	Amneal
10/16/2018	BICNU	Carmustine	Emcure Pharms	Amneal
10/16/2018	Actigall	Ursodiol	Allergan	Amneal
10/16/2018	Cymbalta	Duloxetine HCl	Eli Lilly	CSPC Ouyi Pharm
10/16/2018	Neurontin	Gabapentin	Eli Lilly	Strides
10/16/2018	Wellbutrin SR	Bupropion HCl	GlaxoSmithKline	Yichang Humanwell
10/16/2018	Fluocinonide	Fluocinonide	Taro	Teligent Pharma
10/17/2018	Prevacid	Lansoprazole	Takeda	Breckenridge
10/17/2018	Epiduo Forte	Adapalene / Benzoyl Peroxide	Galderma Labs	Taro
10/17/2018	Isuprel	Isoproterenol HCl	Hospira	Amneal
10/18/2018	Capastat Sulfate	Capreomycin Sulfate	Akorn	Hisun Pharm Hangzhou
10/18/2018	Diamox	Acetazolamide	Teva	Accord Healthcare
10/18/2018	Levophed	Norepinephrine Bitartrate	Hospira	Sandoz
10/22/2018	Glucophage XR	Metformin HCl	Bristol-Myers Squibb	Alkem
10/22/2018	Onfi	Clobazam	Lundbeck	West-Ward Pharms
10/22/2018	Onfi	Clobazam	Lundbeck	Bionpharma
10/22/2018	Onfi	Clobazam	Lundbeck	Breckenridge
10/22/2018	Onfi	Clobazam	Lundbeck	Taro Pharm
10/22/2018	Onfi	Clobazam	Lundbeck	Upsher-Smith Labs
10/22/2018	Onfi	Clobazam	Lundbeck	West-Ward Pharms
10/22/2018	Onfi	Clobazam	Lundbeck	Amneal
10/22/2018	Onfi	Clobazam	Lundbeck	Hetero Labs
10/22/2018	Onfi	Clobazam	Lundbeck	Piramal
10/22/2018	Onfi	Clobazam	Lundbeck	Upsher-Smith Labs
10/22/2018	Onfi	Clobazam	Lundbeck	Mylan
10/22/2018	Onfi	Clobazam	Lundbeck	Zydus
10/23/2018	Aleve PM	Naproxen Sodium / Diphenhydramine Hydrochloride (OTC)	Bayer	Amneal
10/23/2018	Topicort	Desoximetasone	Taro Pharm	Teligent Pharma
10/24/2018	Ampyra	Dalfampridine	Acorda	West-Ward Pharms
10/25/2018	Zithromax	Azithromycin	Pfizer	CSPC Ouyi Pharm
10/25/2018	Ritalin	Methylphenidate HCl	Novartis	Aurolife Pharma
10/25/2018	Renvela	Sevelamer Carbonate	Genzyme	Dr Reddy's Labs
10/25/2018	Derma-Smoothe/FS	Flucinolone Acetonide	Hill Dermac	Glenmark
10/26/2018	Toprol-XL	Metoprolol Succinate	Aralez Pharms	Cipla
10/26/2018	Aubagio	Teriflunomide	Sanofi Aventis	Aurobindo
10/26/2018	Derma-Smooth/FS	Fluocinonide Acetonide	Hill Dermac	Glenmark
10/26/2018	Prometrium	Progesterone	Virtus Pharms	Eugia Pharma
10/26/2018	Clobex	Clobetasol Propionate	Galderma Labs	Hi-Tech Pharmacal
10/26/2018	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Amneal
10/26/2018	Robaxin	Methocarbamol	West-Ward Pharms	Gland Pharma
10/26/2018	Cytomel	Liothyronine Sodium	King Pharms	Teva
10/26/2018	Zetia	Ezetimibe	Merck Sharp & Dome	Accord Healthcare
10/30/2018	Urso 250	Ursodiol	Allergan	Zydus
10/31/2018	Clolar	Clofarabine	Genzyme	Gland Pharma
10/31/2018	Zytiga	Abiraterone Acetate	Janssen	Hikma
10/31/2018	Zytiga	Abiraterone Acetate	Janssen	Teva
10/31/2018	Zytiga	Abiraterone Acetate	Janssen	Mylan
10/31/2018	Zytiga	Abiraterone Acetate	Janssen	Apotex
10/31/2018	Anafranil	Clomipramine HCl	Specgx	Amneal
10/31/2018	Levitra	Vardenafil HCl	Bayer	Zydus
10/31/2018	Levitra	Vardenafil HCl	Bayer	CrossMedika
10/31/2018	Wellbutrin XL	Bupropion HCl	Valeant	Accord Healthcare
10/31/2018	Levitra	Vardenafil HCl	Bayer	Amneal
11/1/2018	Mucinex DM	Guaifenesin / Dextromethorphan Hydrobromide (OTC)	RB Hlth	Ameal
11/1/2018	Hectorol	Doxercalciferol	Hospira / Sanofi	Lupin
11/2/2018	Bentyl	Dicyclomine HCl	Allergan	Renaissance
11/2/2018	Betapace AF	Sotalol HCl	Covis Pharma	Beximco Pharms
11/2/2018	Aubagio	Teriflunomide	Sanofi Aventis	Apotex
11/2/2018	Fortamet	Metformin HCl	Andrx Labs	Novast Labs
11/5/2018	Cleocin Hydrochloride	Clindamycin HCl	Pharmacia and Upjohn	Micro Labs
11/5/2018	Omeprazole	Omeprazole (OTC)	Dexcel Pharma	Dr Reddy's Labs
11/5/2018	Xopenex	Levalbuterol HCl	Oak Pharms	Sun
11/5/2018	Synalar	Fluocinolone Acetonide	Medimetriks Pharms	G and W Labs
11/6/2018	Aloxi	Palonosetron HCl	Helsinn Healthcare	Aurobindo
11/6/2018	Frova	Frovatriptan Succinate	Endo Pharms	Amneal
11/7/2018	Levophed	Norepinephrine Bitartrate	Hospira	Hikma
11/7/2018	Achromycin V	Tetracycline HCl	Heritage Pharms	Breckenridge
11/8/2018	Cytovene	Ganciclovir	Roche	Hainan Poly Pharm
11/9/2018	Atripla	Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead Sciences	Teva
11/9/2018	Arimidex	Anastrozole	ANI Pharms	Beijing Yiling
11/9/2018	Valcyte	Valganciclovir HCl	Roche	Cipla
11/9/2018	Tessalon	Benzonatate	Pfizer	Aiping Pharm
11/9/2018	Dacogen	Decitabine	Otsuka	Lupin
11/9/2018	Pulmicort Respules	Budesonide	AstraZeneca	Lupin
11/13/2018	Lomotil	Diphenoxylate HCl / Atropine Sulfate	GD Searle	Bayshore Pharms
11/14/2018	Femara	Letrozole	Novartis	Beijing Yiling
11/14/2018	Arixtra	Fondaparinux Sodium	Mylan	Scinopharm
11/15/2018	Epzicom	Abacavir Sulfate / Lamivudine	ViiV Healthcare	Aurobindo Pharma
11/15/2018	Diprivan	Propofol	Fresenius Kabi USA	Dr Reddy's Labs
11/15/2018	Acular LS	Ketorolac Tromethamine	Allergan	Aurobindo Pharma
11/15/2018	Epzicom	Abacavir Sulfate / Lamivudine	ViiV Healthcare	Zydus
11/15/2018	Aubagio	Teriflunomide	Sanofi Aventis	Glenmark
11/16/2018	Aleve	Naproxen Sodium (OTC)	Bayer	Novelgenix Theraps
11/16/2018	Staxyn	Vardenafil HCl	Bayer	Alembic Pharms
11/16/2018	Zyrtec-D 12 Hour	Cetirizine HCl / Pseudoephedrine HCl (OTC)	Johnson and Johnson	Perrigo
11/16/2018	Anectine / Quelicin	Succinylcholine Chloride	Sandoz / Hospira	Amneal
11/19/2018	Zometa	Zoledronic Acid	Novartis	Dr Reddy's Labs
11/19/2018	Finacea	Azelaic Acid	Leo Pharma	Glenmark
11/19/2018	Zyprexa	Olanzapine	Eli Lilly	Sunshine Lake
11/19/2018	Finacea	Azelaic Acid	Leo Pharma	Actavi
11/19/2018	Finacea	Azelaic Acid	Leo Pharma	Tolmar
11/19/2018	Abreva	Docosanol (OTC)	GlaxoSmithKline	Actavis
11/20/2018	Lialda	Mesalamine	Shire	Mylan
11/20/2018	Butrans	Buprenorphine	Purdue Pharma	Teva
11/20/2018	Lipitor	Atorvastatin Calcium	Pfizer	Zydus
11/20/2018	Sabril	Vigabatrin	Lundbeck	Dr Reddy's Labs
11/20/2018	Xyzal Allergy 24Hr	Levocetirizine Dihydrochloride (OTC)	Sanofi Aventis	Micro Labs
11/21/2018	Anafranil	Clomipramine HCl	Specgx	Lupin
11/21/2018	Voltaren	Diclofenac Sodium	GlaxoSmithKline	Hi-Tech Pharmacal
11/21/2018	Mepron	Atovaquone	GlaxoSmithKline	Glenmark
11/21/2018	Rocaltrol	Calcitriol	Validus Pharms	Invatech Pharma
11/21/2018	Potassium Chloride	Potassium Chloride	Pharma Res Software	Novel Labs
11/21/2018	Fluoxetine HCl	Fluoxetine HCl	Alvogen	Appco Pharma
11/23/2018	Effexor XR	Venlafaxine HCl	Wyeth	Intellipharmaceutics
11/23/2018	Pravachol	Pravastatin Sodium	Bristol-Myers Squibb	Hisun Pharm Hangzhou
11/23/2018	Daliresp	Roflumilast	AstraZeneca	Hetero Labs
11/23/2018	Integrilin	Eptifibatide	Schering	Celerity Pharms
11/23/2018	Potassium Chloride	Potassium Chloride	Pharma Res Software	Epic Pharma
11/23/2018	Children's Motrin	Ibuprofen (OTC)	Johnson and Johnson	Aptapharma
11/23/2018	Restoril	Temazepam	Specgx	Alembic
11/26/2018	Prevacid	Lansoprazole	Takeda	Zydus
11/27/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead Sciences	Mylan
11/27/2018	Amicar	Aminocaproic Acid	Clover Pharms	Sunny Pharmtech
11/28/2018	Prevacid	Lansoprazole	Takeda	Mylan
11/29/2018	Renvela	Sevelamer Carbonate	Sanofi	Wilshire Pharms
11/29/2018	Precedex	Dexmedetomidine HCl	Hospira	Fresenius Kabi USA
11/29/2018	Mitigare	Colchicine	Hikm	Par
11/29/2018	Lidex	Fluocinonide	County Line Pharms	Encube Ethicals
11/30/2018	Ganirelix Acetate	Ganirelix Acetate	Organon USA	Sun
11/30/2018	Lamictal XR	Lamotrigine	GlaxoSmithKline	Amneal
11/30/2018	Aubagio	Teriflunomide	Sanofi Aventis	Zydus
11/30/2018	Vfend	Voriconazole	PF Prism CV	Hainan Poly Pharm
12/3/2018	Rapaflo	Silodosin	Allergan	Lupin
12/3/2018	Azor	Amlodipine / Olmesartan Medoxomil	Daiichi Sankyo	Sciegen Pharms
12/3/2018	Rapaflo	Silodosin	Allergan	Amneal
12/3/2018	Rapaflo	Silodosin	Allergan	MSN Labs
12/3/2018	Fluoxetine HCl	Fluoxetine HCl	Alvogen	Teva
12/3/2018	Rapaflo	Silodosin	Allergan	Ajanta
12/3/2018	Rapaflo	Silodosin	Allergan	MacLeods
12/4/2018	Fareston	Toremifene Citrate	Kyowa Kirin	Eirgen Pharma
12/4/2018	Atacand	Candesartan Cilexetil	ANI Pharms	Alembic
12/6/2018	Singulair	Montelukast Sodium	Merck Sharp & Dome	Cipla
12/6/2018	Zithromax	Azithromycin	Pfizer	Sunshine Lake
12/6/2018	Progesterone	Progesterone	Actavis	Eugia Pharma
12/7/2018	Lotrel	Amlodipine Besylate / Benazepril HCl	Novartis	Cipla
12/7/2018	Zithromax	Azithromycin	Pfizer	Sunshine Lake
12/7/2018	Zithromax	Azithromycin	Pfizer	Sunshine Lake
12/7/2018	Patanol	Olopatadine HCl	Novartis	Alembic
12/7/2018	Albenza	Albendazole	Impax	Strides Vivimed
12/10/2018	Rapaflo	Silodosin	Allergan	Aurobindo
12/13/2018	Aptensio XR	Methylphenidate HCl	Rhodes Pharms	Actavis
12/14/2018	Albenza	Albendazole	Impax Labs	Zydus
12/14/2018	Onfi	Clobazam	Lundbeck	Lupin
12/14/2018	Heparin Sodium	Heparin Sodium	West-Ward Pharms Int / Fresenius Kabi USA	Nanjing King-Friend
12/14/2018	Dermotic	Fluocinonide Acetonide	Hill Dermac	Glenmark
12/17/2018	Levophed	Norepinephrin Bitartrate	Hospira	Amneal
12/18/2018	Cyanocobalamin	Cyanocobalamin	Luitpold	Vitruvias Therap
12/18/2018	Cyanocobalamin	Cyanocobalamin	Luitpold	Somerset Therapeutics
12/19/2018	Tessalon	Benzonatate	Pfizer	Puracap Pharm
12/19/2018	Mirapex	Pramipexole Dihydrochloride	Boehringer Ingelheim	Unichem Labs
12/19/2018	Toprol-XL	Metoprolol Succinate	Aralez Pharms	Twi
12/19/2018	Klor-Con	Potassium Chloride	Upsher Smith Labs	Aurobindo
12/21/2018	Claritin	Loratadine (OTC)	Bayer	Bionpharma
12/21/2018	Tygacil	Tigecycline	PF Prism CV	Apotex
12/21/2018	Golytely	Polyethylene Glycol 3350 and Electrolytes	Braintree	Strides
12/21/2018	Doryx	Doxycycline Hyclate	Mayne Pharma	Zydus
12/21/2018	Levothyroxine Sodium	Levothyroxine Sodium	Fresenius Kabi USA	Maia Pharms
12/21/2018	Lipitor	Atorvastatin Calcium	Pfizer	The Pharma Network
12/21/2018	Vazculep	Phenylephrine HCL	West-Ward Pharm Corp / Avadel Legacy	Par Sterile
12/26/2018	Gris-PEG	Griseofulvin, Ultramicrosize	Valeant	Sandoz
12/26/2018	Zithromax	Azithromycin	Pfizer	Bionpharma
12/27/2018	Sensipar	Cinacalcet HCl	Amgen	Teva
12/27/2018	Sandostatin	Octreotide Acetate	Novartis	USV North America
12/27/2018	Elidel	Pimecrolimus	Valeant	Actavis
12/27/2018	Fortamet	Metformin HCl	Andrx Labs	Qingdao Baheal
12/27/2018	Clolar	Clofarabine	Genzyme	Hospira
12/28/2018	Aromasin	Exemestane	Pharmacia and Upjohn	Amneal
12/28/2018	Camptosar	Irinotecan HCl	Pfizer	Shilpa Medicare
12/28/2018	Onfi	Clobazam	Lundbeck	Lupin
12/28/2018	Makena	Hydroxyprogesterone Caproate	Amag Pharma USA	Slayback Pharma
12/28/2018	Duac	Clindamycin Phosphate / Benzoyl Peroxide	Stiefel	Zydus
12/31/2018	Rogaine	Minoxidil	Johnson and Johnson	Taro Pharm