ANDA Approvals

Winter 2015

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
10/5/2015	Indomethacin	Indomethacin	Sandoz	Jubilant Generics
10/7/2015	Trilipix	Fenofibric Acid	Abbvie	Actavis Elizabeth
10/7/2015	Ketorolac Tromethamine	Ketorolac Tromethamine	Hospira	BD RX
10/8/2015	Abilify	Aripiprazole	Otsuka	Aurobindo Pharma
10/8/2015	Singulair	Montelukast Sodium	Merck	Unichem Labs
10/13/2015	Namenda	Memantine Hydrochloride	Forest Labs	Jubilant Generics
10/13/2015	Namenda	Memantine Hydrochloride	Forest Labs	Unichem Labs
10/13/2015	Namenda	Memantine Hydrochloride	Forest Labs	Torrent Pharms
10/13/2015	Namenda	Memantine Hydrochloride	Forest Labs	Alembic Pharms
10/13/2015	Namenda	Memantine Hydrochloride	Forest Labs	MacLeods Pharms
10/13/2015	Namenda	Memantine Hydrochloride	Forest Labs	MacLeods Pharms
10/13/2015	Namenda	Memantine Hydrochloride	Forest Labs	Aurobindo Pharma
10/13/2015	Namenda	Memantine Hydrochloride	Forest Labs	Silarx Pharms
10/13/2015	Aloxi	Palonosetron Hydrochloride	Helsinn Healthcare	Teva
10/13/2015	Aloxi	Palonosetron Hydrochloride	Helsinn Healthcare	Sandoz
10/14/2015	Cozaar	Losartan Potassium	Merck Sharp & Dohme	Unichem Labs
10/15/2015	Viramune XR	Nevirapine	Boehringer Ingelheim	Cipla
10/16/2015	Maxalt T-MLT	Rizatriptan Benzoate	Merck	Jubilant Generics
10/16/2015	Boniva	Ibandronate Sodium	Roche	Apotex
10/16/2015	Buprenorphine Hydrochloride / Naloxone Hydrochloride	Buprenorphine Hydrochloride / Naloxone Hydrochloride	Actavis Elizabeth	Ethypharm USA
10/19/2015	Nexium	Esomeprazole Magnesium	AstraZeneca	Torrent Pharms
10/19/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	3D Imaging Drug
10/19/2015	Ammonia N 13	Ammonia N 13	Feinstein	3D Imaging Drug
10/20/2015	Ampicillin Sodium	Ampicillin Sodium	Sandoz	Sagent Pharms
10/20/2015	Intuniv	Guanfacine Hydrochloride	Shire	Impax Labs
10/20/2015	Zyprexa	Olanzapine	Lilly	Alkem Labs
10/20/2015	Levoleucovorin Calcum	Levoleucovorin Calcium	Sandoz	Mylan
10/20/2015	Ultram ER	Tramadol Hydrochloride	Valeant	Aurobindo Pharma
10/21/2015	Modicon 28	Norethindrone / Ethinyl Estradiol	Janssen Pharms	Jai Pharma
10/21/2015	Ortho-Novum 1/35-28	Norethindrone / Ethinyl Estradiol	Janssen Pharms	Jai Pharma
10/22/2015	Yaz	Drospirenone / Ethinyl Estradiol	Bayer Healthcare	Jai Pharma
10/22/2015	Aricept	Donepezil Hydrochloride	Eisai	Mylan
10/22/2015	Zomig-ZMT	Zolmitriptan	AstraZeneca	MacLeods Pharms
10/23/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	Triad Isotopes
10/26/2015	Phoslo Gelcaps	Calcium Acetate	Fresenius Medical	Nostrum Labs
10/27/2015	Ortho Cyclen-28	Norgestimate / Ethinyl Estradiol	Janssen Pharms	Haupt Pharma
10/27/2015	Lamictal ODT	Lamotrigine	GlaxoSmithKline	Par Pharm
10/27/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	UCLA Biomedical	Kettering MedCtr
10/28/2015	Cymbalta	Duloxetine Hydrochloride	Lilly	Anchen Pharms
10/28/2015	Blisovi 24Â	FENorethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	Amneal Pharms	Lupin
10/28/2015	Cymbalta	Duloxetine Hydrochloride	Lilly	Inventia Healthcare
10/29/2015	Choline C-11	Choline C-11	MCPRF	Univ TX MD Anderson
10/30/2015	Aricept	Donepezil Hydrochloride	Eisai	Lupin
10/30/2015	Lotrisone	Clotrimazole / Betamethasone Dipropionate	Merck Sharp & Dohme	Glenmark Pharms
10/30/2015	Fiorinal w/Codeine	Butalbital / Aspirin / Caffeine / Codeine Phosphate	Actavis Labs UT	Coastal Pharms
10/30/2015	Butapap	Butalbital / Acetaminophen	Mikart	Tedor Pharma
10/30/2015	Micardis	Telmisartan	Boehringer Ingelheim	Inventia Healthcare
10/30/2015	Sporanox	Itraconazole	Janssen Pharms	Amneal Pharms
11/2/2015	Micardis HCT	Telmisartan / Hydrochlorothiazide	Boehringer Ingelheim	MacLeods Pharms
11/3/2015	Ultane	Sevoflurane	Abbvie	Shanghai Hengrui
11/4/2015	Felbatol	Felbamate	Meda Pharms	Corepharma
11/5/2015	Actoplus Met	Pioglitazone Hydrochloride / Metformin Hydrochloride	Takeda	MacLeods Pharms
11/5/2015	Singulair	Montelukast Sodium	Merck	Anbison Lab
11/5/2015	Klor-Con	Potassium Chloride	Upsher-Smith Labs	Paddock
11/9/2015	Viramune XR	Nevirapine	Boehringer Ingelheim	Alvogen Malta
11/9/2015	Axert	Almotriptan Malate	Janssen Pharms	Mylan
11/10/2015	Dextroamp Saccharate / AMP Aspartate / AMP Sulfate	Dextroamp Saccharate / AMP Aspartate / AMP Sulfate	Barr	Mylan
11/12/2015	Ortho Tri-Cyclen	Norgestimate / Ethinyl Estradiol	Janssen Pharms	Haupt Pharma
11/12/2015	Soma	Carisoprodol	Meda Pharms	Shasun Pharms
11/12/2015	Baraclude	Entecavir	Bristol Myers Squibb	Amneal Pharms
11/13/2015	NTEs	Fludeoxyglucose F18		Cardinal Health 414
11/13/2015	Seasonale	Levonorgestrel / Ethinyl Estradiol	Teva Branded Pharm	Haupt Pharma
11/13/2015	Choline C-11	Choline C-11	MCPRF	Global Isotopes
11/13/2015	Ritalin	Methylphenidate Hydrochloride	Novartis	Novel Labs
11/16/2015	Voltaren	Diclofenac Sodium	Novartis	Altaire Pharms
11/17/2015	Desoxyn	Methamphetamine Hydrochloride	Recordati Rare	Roxane
11/17/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	Midwest Medical
11/17/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	UIHC Pet Imaging
11/17/2015	Namenda	Memantine Hydrochloride	Forest Labs	Puracap Pharm
11/18/2015	Loestrin FE 1.5/30	Blisovi FE 1.5/30	Warner Chilcott	Lupin
11/18/2015	Revatio	Sildenafil Citrate	Pfizer	Aurobindo Pharma
11/18/2015	Aciphex	Rabeprazole Sodium	Eisai	Breckenridge Pharm
11/19/2015	Trivora-28	Levonorgestrel / Ethinyl Estradiol	Watson Labs	Lupin
11/19/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Midwest Medical
11/20/2015	Avodart	Dutasteride	GlaxoSmithKline	Banner Pharmacaps
11/20/2015	Avodart	Dutasteride	GlaxoSmithKline	Vintage Pharms LLC
11/20/2015	Avodart	Dutasteride	GlaxoSmithKline	Rising Pharms Inc
11/20/2015	Avodart	Dutasteride	GlaxoSmithKline	Sandoz
11/20/2015	Avodart	Dutasteride	GlaxoSmithKline	Actavis Labs FL
11/20/2015	Avodart	Dutasteride	GlaxoSmithKline	Amneal Pharms
11/20/2015	Avodart	Dutasteride	GlaxoSmithKline	Strides Arcolab
11/20/2015	Avodart	Dutasteride	GlaxoSmtihKline	Breckenridge Pharm
11/20/2015	Jalyn	Dutasteride / Tamsulosin Hydrochloride	GlaxoSmithKline	Actavis Labs FL
11/23/2015	Avodart	Dutasteride	GlaxoSmithKline	Roxane
11/23/2015	Ditropan XL	Oxybutynin Chloride	Janssen Pharms	Amneal Pharms
11/23/2015	Embeline	Clobetasol Propionate	Hi Tech Pharma	Novel Labs
11/24/2015	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Barr	Avanthi
11/24/2015	Avodart	Dutasteride	GlaxoSmithKline	Apotex
11/24/2015	Canasa	Mesalamine	Forest Labs	Mylan
11/24/2015	Fazaclo ODT	Clozapine	Jazz Pharms	Barr Labs
11/25/2015	Clozaril	Clozapine	Heritage Life	Accord Healthcare
11/27/2015	Ampicillin Sodium	Ampicillin Sodium	Sandoz	Sagent Pharms
11/27/2015	Paxil	Paroxetine Hydrochloride	Apotex	Jubilant Generics
11/30/2015	Actonel	Risedronate Sodium	Warner Chilcott	Apotex
11/30/2015	Actonel	Risedronate Sodium	Warner Chilcott	Sun Pharma Global
11/30/2015	Actonel	Risedronate Sodium	Warner Chilcott	Aurobindo Pharma
11/30/2015	Actonel	Risedronate Sodium	Warner Chilcott	Mylan
11/30/2015	Namenda	Memantine Hydrochloride	Forest Labs	Ajanta Pharma
12/1/2015	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Luitpold	Aurobindo Pharma
12/2/2015	Solaraze	Diclofenac Sodium	Fougera Pharms	Actavis Mid Atlantic
12/3/2015	Gleevec	Imatinib Mesylate	Novartis	Sun Pharma
12/4/2015	Trivora-28	Elifemme	Watson Labs	SandozÂ
12/4/2015	Butapap	Butalbital / Acetaminophen	Mikart	Larken Labs
12/4/2015	Focalin	Dexmethylphenidate Hydrochloride	Novartis	Novel Labs
12/4/2015	Focalin	Demethylphenidate Hydrochloride	Novaris	Abhai
12/7/2015	Patanol	Olopatadine Hydrochloride	Alcon	Apotex
12/7/2015	Unasyn	Ampicillin / Sulbactam	Pfizer	Antibiotics SA
12/7/2015	Avapro	Irbesartan	Sanofi Aventis	Unichem Labs
12/7/2015	Patanol	Olopatadine Hydrochloride	Alcon	USV North America
12/7/2015	Patanol	Olopatadine Hydrochloride	AlconÂ	Zach System Spa
12/7/2015	Avapro	Irbesartan	Sanofi Aventis	Sciegen Pharms
12/7/2015	Levothyroxine Sodium	Levothyroxine Sodium	Fresenius Kabi USA	Par Sterile Products
12/7/2015	Namenda	Memantine Hydrochloride	Forest Labs	Bio-Pharm
12/7/2015	Patanol	Olopatadine Hydrochloride	Alcon	Novel Labs
12/8/2015	Potassium Chloride	Potassium Chloride	Actavis Labs FL	Pharmaceutics Int'l
12/8/2015	Integrilin	Eptifibatide	Schering	Aurobindo Pharma
12/8/2015	Plan B One-Step (OTC)	Athentia Next (OTC)	Teva Branded Pharm	Aurobindo Pharma
12/9/2015	Amikacin Sulfate	Amikacin Sulfate	Eurohealth Intl	Fresenius Kabi USA
12/9/2015	Amikacin Sulfate	Amikacin Sulfate	Eurohealth Intl	Fresenius Kabi USA
12/9/2015	Pennsaid	Diclofenac Sodium	Nuvo Res	Novel Labs
12/9/2015	Cyclogyl	Cyclopentolate Hydrochloride	Alcon	Akorn
12/10/2015	Imitrex Statdose	Sumatriptan Succinate	GlaxoSmithKline	Antares Pharma
12/10/2015	Avapro	Irbesartan	Sanofi Aventis	Ajanta Pharma
12/10/2015	FyavolvÂ	Norethindrone Acetate / Ethinyl Estradiol	Barr Labs	Lupin
12/10/2015	Toviaz	Fesoterodine Fumarate	Pfizer	Alkem Labs
12/10/2015	Norvasc	Amlodipine Besylate	Pfizer	Ascent Pharms
12/11/2015	Oxacillin Sodium	Oxacillin Sodium	Sandoz	Hospira
12/11/2015	Niaspan	Niacin	Abbvie	Amneal Pharms
12/11/2015	Starlix	Nateglinide	Novartis	Alvogen Malta
12/11/2015	Cyanocobalamin / Vibisone	Cyanocobalamin / Vibisone	Luitpold / Fresenius Kabi USA	Gavis Pharms
12/15/2015	Benzphetamine Hydrochloride	Benzphetamine Hydrochloride	KVK Tech	Epic Pharma
12/15/2015	Citalopram Hydrobromide	Citalopram Hydrobromide	Roxane	Hetero Labs
12/15/2015	Miralax (OTC)	Polyethylene Glycol 3350 (OTC)	Bayer Healthcare	Ani Pharms
12/15/2015	Imodium A-D (OTC)	Loperamide Hydrochloride (OTC)	J & J Consumer	Aurobindo Pharma
12/15/2015	Solu-Medrol	Methylprednisolone Sodium Succinate	Pharmacia and Upjohn	Aurobindo Pharma
12/16/2015	Buspirone Hydrochloride	Buspirone Hydrochloride	Teva	Orion Corp Orion
12/16/2015	Modicon 28	Cyclafem 0.5/35	Janssen Pharms	Vintage Pharms
12/16/2015	MS Contin	Morphine Sulfate	Purdue Pharma	Novel Labs
12/16/2015	Keppra	Levetiracetam	UCB	Secan Pharms
12/17/2015	Aricept	Donepezil Hydrochloride	Eisai	Actavis Elizabeth
12/17/2015	Kaitlib FEÂ	Norethindrone / Ethinyl Estradiol / Ferrous Fumarate	Warner Chilcott	Lupin
12/17/2015	Perphenazine	Perphenazine	Sandoz	Indicus Pharma
12/18/2015	Potassium Chloride	Potassium Chloride	Actavis Labs FL	Lupin
12/18/2015	Corgard	Nadolol	US World Meds	Invagen Pharms
12/18/2015	Patanol	Olopatadine Hydrochloride	Alcon	Aurobindo Pharma
12/18/2015	Merrem	Meropenem	AstraZeneca	Daewoong Pharm
12/21/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Mylan
12/21/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Glenmark Pharms
12/21/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Hetero Labs
12/21/2015	Focalin XR	Dexmethylphenidate Hydrochloride	Novartis	Mylan
12/21/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Amneal Pharms
12/21/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Alembic Pharms
12/21/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Alkem Labs
12/21/2015	Busulfex	Busulfan	Otsuka Pharm	Pharmaforce
12/22/2015	Ultram ER	Tramadol Hydrochloride	Valeant	Mylan
12/22/2015	Diprivan	Propofol	Fresenius Kabi USA	Watson Labs
12/22/2015	Pepcid	Famotidine	Valeant Pharms North	Aurobindo Pharma
12/23/2015	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Teva
12/23/2015	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Teva
12/23/2015	Soriatane	Acitretin	Stiefel Labs	Watson Labs
12/23/2015	Celexa	Citalopram Hydrobromide	Forest Labs	Jubilant Generics
12/23/2015	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Xellia Pharms
12/23/2015	Neurontin	Gabapentin	Pfizer Pharms	Alkem Labs
12/23/2015	Celebrex	Celecoxib	GD Searle	Torrent Pharms
12/24/2015	Reclast	Zoledronic Acid	Novartis	Apotex
12/28/2015	Ortho-Novum 7/7/7-28	Norethindrone / Ethinyl Estradiol	Janssen Pharms	Jai Pharma
12/28/2015	Cefazolin Sodium	Cafezolin Sodium	Hospira	Qilu Pharm
12/28/2015	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Custopharm
12/28/2015	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Custopharm
12/28/2015	Bloxiverz	Neostigmine Methylsulfate	Eclat Pharms	Eurohealth Int'l
12/29/2015	Potassium Acetate	Potassium Acetate	Hospira	Exela Pharma SCS
12/30/2015	Minocycline Hydrochloride	Minocycline Hydrochloride	Sandoz	Sidmak Labs India