ANDA Approvals

Fall 2015

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
7/7/2015	Axert	Almotriptan Malate	Janssen Pharms	Teva Pharms USA
7/7/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Hospira
7/8/2015	Soma	Carisoprodol	Meda Pharms	Indicus Pharma
7/8/2015	Pennsaid	Diclofenac Sodium	Nuvo Research	IGI Labs
7/8/2015	Flecainide Acetate	Flecainide Acetate	Roxane	Aurobindo Pharma
7/9/2015	Phoslo Gelcaps	Calcium Acetate	Fresenius Medical	Lupin
7/9/2015	Macrobid	Nitrofurantoin (Monohydrate/ Macrocrystals)	Alvogen	Watson Labs
7/10/2015	Klor-Con	Pottasium Chloride	Actavis	Upsher Smith
7/10/2015	Viramune XR	Nevirapine	Boehringer Ingelheim	Alvogen Pine Brook
7/10/2015	Travatan Z	Travoprost	Alcon Pharms	Apotex
7/13/2015	Pataday	Olopatadine Hydrochloride	Alcon Pharms	Barr Labs
7/13/2015	Zofran	Ondansetron Hydrochloride	Novartis Pharms Corp	Accord Healthcare
7/13/2015	Tobi	Tobramycin	Novartis Pharms	Amneal Pharms
7/14/2015	Angiomax	Bivalirudin	Medicines Co	Hospira
7/14/2015	Angiomax	Bivalirudin	Medicines Co	Hospira
7/14/2015	Protonix IV	Pantoprazole Sodium	Wyeth	Sandoz
7/15/2015	Qualaquin	Quinine Sulfate	Mutual Pharm Co	Amneal Pharms
7/15/2015	Prandimet	Repaglinide / Metformin Hydrochloride	Novo Nordisk	Lupin
7/16/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Sandoz
7/20/2015	Bimatoprost	Bimatoprost	Lupin	Apotex
7/21/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	MIPS CRF
7/22/2015	Qualaquin	Quinine Sulfate	Mutual Pharm Co	RiconPharma
7/23/2015	Norvasc	Amlodipine Besylate	Pfizer	Sovereign Pharms
7/23/2015	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare	Aurobindo Pharma
7/24/2015	Abilify	Aripiprazole	Otsuka	Apotex
7/24/2015	Diflorasone Diacetate	Diflorasone Diacetate	Taro	VersaPharm
7/24/2015	Niaspan	Niacin	Abbvie	Amneal Pharms
7/24/2015	Nimodipine	Nimodipine	Bannar Life Sciences	Sofgen Pharms
7/27/2015	Lithobid	Lithium Carbonate	Ani Pharms	Unique Pharm Labs
7/28/2015	Astelin	Azelastine Hydrochloride	Meda Pharms	Breckenridge Pharms
7/28/2015	Buprenex	Buprenorphine Hydrochloride	Indivior	Par Sterile Products
7/28/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	University of Michigan
7/28/2015	Folic Acid	Folic Acid	Amneal Pharm/Watson Labs	Nuvo Pharm
7/29/2015	Edecrin	Ethacrynate Sodium	Aton	Par Sterile Products
7/29/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	Hot Shots NM
7/30/2015	Benzonatate	Benzonatate	The Pharma Network	Strides Arcolab
7/30/2015	Prilosec OTC	Omeprazole Magnesium	Astrazeneca	Perrigo
7/30/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	Cardnal Health 414
7/31/2015	Benzonatate	Benzonatate	The Pharma Network	CSPC NBP Pharm
7/31/2015	Claritin	Loratadine	Bayer Healhcare	Taro
7/31/2015	Namenda	Memantine Hydrochloride	Forest Labs	Upsher Smith
7/31/2015	Aciphex	Rabeprazole Sodium	Eisai	Amneal Pharms
8/3/2015	Xanax	Alprazolam	Pharmacia and Upjohn	Aurobindo Pharma
8/3/2015	Nexium	Esomeprazole Magnesium	Astrazeneca	Mylan Labs
8/3/2015	Zutripro	Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride	Cypress Pharm	Coastal Pharms
8/3/2015	Advil	Ibuprofen Sodium	Pfizer Consumer Healthcare	Perrigo
8/3/2015	Singulair	Montelukast Sodium	Merck	Ajanta Pharma
8/3/2015	Singulair	Montelukast Sodium	Merck	Ajanta Pharma
8/3/2015	Singulair	Montelukast Sodium	Merck	Ajanta Pharma
8/3/2015	Invega	Paliperidone	Janssen Pharms	Actavis
8/4/2015	Androgel	Testosterone	Abbvie	Perrigo Israel
8/4/2015	Tindamax	Tinidazole	Mission Pharma	Edenbridge Pharms
8/5/2015	Zyrtec	Cetirizine Hydrochloride	McNeil Consumer	Aurobindo Pharma
8/5/2015	Zyrtec	Cetirizine Hydrochloride	McNeil Consumer	Aurobindo Pharma
8/5/2015	Precedex	Dexmethylphenidate Hydrochloride	Hospira	Watson Labs
8/5/2015	Fortesta	Testosterone	Endo Pharms	Actavis
8/7/2015	Amiloride Hydrochloride	Amiloride Hydrochloride	Par Pharm	Zydus Pharms USA
8/7/2015	Lidocaine	Lidocaine	Fougera	Amneal Pharms
8/7/2015	Lidoderm	Lidocaine	Teikoku Pharma USA	Mylan Technologies
8/7/2015	Mirapex ER	Pramipexole Dihydrochloride	Boehringer Ingelheim	Dr. Reddy's
8/11/2015	Detrol LA	Tolterodine Tartrate	Pharmacia and Upjohn	Torrent Pharms
8/12/2015	Kariva	Bekyree	Barr	Lupin
8/12/2015	Ortho-Cept	Isibloom	Janssen Pharms	Sandoz
8/12/2015	Levaquin	Levofloxacin	Janssen Pharms	Hospira
8/12/2015	Cozaar	Lorsartan Potassium	Merck Sharp Dohme	Hetero Labs
8/13/2015	Keppra	Levetiracetam	UCB	Fresenius Kabi USA
8/13/2015	Atralin	Tretinoin	Dow Pharm	Spear Pharms
8/14/2015	Ammonia N 12	Ammonia N 13	Feinstein	Precision Nuclear
8/14/2015	Abilify	Aripiprazole	Otsuka	Amneal Pharms
8/14/2015	Abilify	Aripiprazole	Otsuka	Silarx Pharms
8/14/2015	Xylocaine	Lidocaine Hydrochloride	Fresenius Kabi USA	Luitpold
8/14/2015	Methylin	Methylphenidate Hydrochloride	Mallinckrodt	Novel Labs
8/17/2015	Yaz	Drospirenone / Ethinyl Estradiol	Bayer Healthcare	Glenmark Pharms
8/17/2015	Fenofibrate	Fenofibrate	Teva	Lupin
8/17/2015	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Lehigh Valley	Avanthi
8/17/2015	Xenazine	Tetrabenazine	Valeant	Sun Pharma Global
8/18/2015	Cisplatin	Cisplatin	Fresenius Kabi USA	Accord Healthcare
8/18/2015	Demeclocycline Hydrochloride	Demeclocycline Hydrochloride	Amneal Pharm	Epic Pharma
8/18/2015	Dolophine Hydrochloride	Methadone Hydrochloride	Roxane	Corepharma
8/18/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	IBA Molecular N Am
8/19/2015	Boniva	Ibandronate Sodium	Roche	Lupin
8/19/2015	Prilosec	Omeprazole	Astrazeneca	Aurobindo Pharma USA
8/20/2015	Pennsaid	Diclofenac Sodium	Nuvo Research	Lupin
8/20/2015	Rozerem	Ramelteon	Takeda Pharms USA	Actavis
8/21/2015	Celebrex	Celecoxib	GD Searle	Alembic Pharms
8/24/2015	Delalutin	Hydroxyprogesterone Caproate	Bristol-Myers Squibb	McGuff
8/24/2015	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Lehigh Valley	Novel Labs
8/24/2015	Rythmol SR	Propafenone Hydrochloride	GlaxoSmithKline	Watson Labs
8/25/2015	Focalin XR	Dexmethylphenidate Hydrochloride	Novartis	Mylan Pharms
8/25/2015	Prilosec	Omeprazole	Astrazeneca	Lupin
8/26/2015	Baraclude	Entecavir	Bristol-Myers Squibb	Aurobindo Pharma
8/26/2015	Prometh VC	Promethazine Hydrochloride / Phenylephrine Hydrochloride w/Codiene Phosphate	Actavis	Amneal Pharms
8/28/2015	Tarceva	Erlotinib Hydrochloride	OSI Pharms	Teva Pharms USA
8/28/2015	Lexapro	Escitalopram Oxalate	Forest Labs	Prinston
8/28/2015	Evista	Raloxifene Hydrochloride	Eli Lilly	Aurobindo Pharma
8/31/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	IBA Molecular N Am
8/31/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Queen Hamamatsu Pet
8/31/2015	Mucinex DM	Guaifenesin and Dextromethorphan Hydrobromide	Reckitt Benckiser	Actavis
8/31/2015	Dolophine Hydrochloride	Methadone Hydrochloride	Roxane	Aurolife Pharma
8/31/2015	Avelox	Moxifloxacin Hydrochloride	Bayer Healthcare	Mylan Pharms
8/31/2015	Detrol	Tolterodine Tartrate	Pharmacia and Upjohn	MacLeods Pharms
9/2/2015	Zyrtec	Cetirizine Hydrochloride	McNeil Consumer	Par Pharm
9/2/2015	Synalar	Fluocinolone Acetonide	Medimetriks Pharms	Gavis Pharms
9/2/2015	Vfend	Voriconazole	PF Prism CV	Glenmark Pharms
9/3/2015	Mucinex	Guaifenesin	Reckitt Benckiser	Actavis
9/3/2015	Levaquin	Levofloxacin in Dextrose 5% in Plastic Container	Janssen Pharms	Hospira
9/3/2015	Exelon	Rivastigmine	Novartis	Alvogen
9/3/2015	Micardis	Telmisartan	Boehringer Ingelheim	Aurobindo Pharma
9/4/2015	Ampicillin Sodium	Ampicillin Sodium	Sandoz	Hospira
9/4/2015	Ampicillin Sodium	Ampicillin Sodium	Sandoz	Hospira
9/4/2015	Topicort	Desoximetasone	Taro	Actavis
9/4/2015	Keppra XR	Levetiracetam	UCB	Dexcel Pharma
9/4/2015	Namenda	Memantine Hydrochloride	Forest Labs	Wockhardt
9/4/2015	Singulair	Montelukast Sodium	Merck	Amneal Pharms
9/8/2015	Giazo	Balsalazide Disodium	Valeant	Par Pharm
9/8/2015	Micardis	Telmisartan	Boehringer Ingelheim	Amneal Pharms
9/9/2015	Ortho Tri-Cyclenlo	Norgestimate / Ethinyl Estradiol	Janssen Pharms	Jai Pharma
9/9/2015	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Xellia Pharms
9/10/2015	Soriatane	Acitretin	Stiefel Labs Inc	Mylan Pharms
9/8/2015	Giazo	Balsalazide Disodium	Valeant	Par Pharm
9/8/2015	Micardis	Telmisartan	Boehringer Ingelheim	Amneal Pharms
9/9/2015	Ortho Tri-Cyclenlo	Norgestimate / Ethinyl Estradiol	Janssen Pharms	Jai Pharma
9/9/2015	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA / Hospira	Xellia Pharms
9/10/2015	Soriatane	Acitretin	Stiefel Labs Inc	Mylan Pharms
9/11/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	MIPS CRF
9/11/2015	Lescol XL	Fluvastatin Sodium	Novartis	Mylan Pharms
9/15/2015	Clarithromycin	Clarithromycin	Teva	Lupin
9/15/2015	Fazaclo ODT	Clozapine	Jazz Pharms	Mylan Pharms
9/15/2015	Ibuprofen	Ibuprofen	Dr Reddy's	Granules India
9/15/2015	Mestinon	Pyridostigmine Bromide	Valeant	Impax Labs
9/16/2015	Taxotere	Docetaxel	Sanofi Aventis	Teva Pharms USA
9/16/2015	Allegra	Fexofenadine Hydrochloride	Sanofi Aventis	Sciegen Pharms
9/16/2015	Allegra	Fexofenadine Hydrochloride	Sanofi Aventis	Sciegen Pharms
9/16/2015	Lopid	Gemfibrozil	Pfizer Pharms	Aurobindo Pharma
9/16/2015	Corgard	Nadolol	King Pharms	Orion Corp
9/17/2015	Zomig-ZMT	Zolmitriptan	Astrazeneca	Jubilant Generics
9/18/2015	Buspirone Hydrochloride	Buspirone Hydrochloride	Teva	Emcure Pharms USA
9/18/2015	Precedex	Dexmedetomidine Hydrochloride	Hospira	Fresenius Kabi USA
9/21/2015	Benzaclin	Clindamycin Phosphate / Benzoyl Peroxide	Valeant	Perrigo Israel
9/21/2015	Benzamycin	Erythromycin / Benzoyl Peroxide	Valeant	Lyne
9/21/2015	Nexium	Esomeprazole Magnesium	Astrazeneca	Hetero Labs
9/21/2015	Testred	Methyltestosterone	Valeant	Impax Labs
9/21/2015	Lysteda	Tranexamic Acid	Ferring Pharms	Mylan
9/22/2015	Cafcit	Caffeine Citrate	Eurohealth Intl	Aurobindo Pharma
9/22/2015	Ritalin	Methylphenidate Hydrochloride	Novartis	Ascent Pharms
9/22/2015	Roxicodone	Oxycodone Hydrochloride	Mallinckrodt	Epic Pharma
9/23/2015	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Ivax Sub Teva Pharms	Mirror Pharms
9/24/2015	Focalin	Dexmethylphenidate Hydrochloride	Novartis	Sun Pharm Inds
9/25/2015	Nexium	Esomeprazole Magnesium	Astrazeneca	Dr. Reddy's
9/25/2015	Nexium	Esomeprazole Sodium	Astrazeneca	Accord Healthcare
9/29/2015	Metadate CD	Methylphenidate Hydrochloride	UCB	Mallinckrodt
9/30/2015	Epiduo	Adapalene / Benzoyl Peroxide	Galderma Labs	Actavis
9/30/2015	Abilify	Aripiprazole	Otsuka	Apotex
9/30/2015	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Prosphate	Luitpold	BD RX
9/30/2015	Zomig	Zolmitriptan	IPR	MacLeods Pharms
9/30/2015	Zomig	Zolmitriptan	IPR	Alembic Pharms