ANDA Approvals

Summer 2015

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
4/1/2015	Femcon FE	Norethindrone / Ethinyl Estradiol / Ferrous Fumarate	Warner Chilcott	Famy Care
4/1/2015	Revatio	Sildenafil Citrate	Pfizer	Aurobindo Pharma
4/3/2015	Exforge	Amlodipine Besylate / Valsartan	Novartis	Alembic Pharms
4/6/2015	Exalgo	Hydromorphone Hydrochloride	Mallinckrodt	Paddock
4/6/2015	MS Contin	Morphine Sulfate	Purdue Pharma	Actavis Elizabeth
4/7/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Precision Nuclear
4/7/2015	Tri-Estarylla	Norgestimate / Ethinyl Estradiol	Sandoz	OC Pharma
4/7/2015	Ortho Cyclen-28	Norgestimate / Ethinyl Estradiol	Janssen Pharms	OC Pharma
4/8/2015	Atracurium Besylate	Atracurium Besylate	Eurohealth International	Aurobindo Pharma
4/8/2015	Atracurium Besylate Preservative Free	Atracurium Besylate Preservative Free	Eurohealth International	Aurobindo Pharma
4/8/2015	Valtrex	Valacyclovir Hydrochloride	GlaxoSmithKline	Hetero Labs
4/9/2015	Levonorgestrel / Ethinyl Estradiol	Levonorgestrel / Ethinyl Estradiol	Watson Labs	Glenmark Generics
4/10/2015	Namenda	Memantine Hydrochloride	Forest Labs	Amneal Pharms
4/10/2015	Namenda	Memantine Hydrochloride	Forest Labs	Lupin Ltd
4/10/2015	Norethindrone Acetate / Ethinyl Estradiol	Norethindrone Acetate / Ethinyl Estradiol	Barr Labs	Glenmark Generics
4/13/2015	Nulytely	PEG-3350 / Potassium Chloride / Sodium Bicarbonate / Sodium Chloride	Braintree Labs	Strides Arcolab
4/13/2015	Kenalog	Triamcinolone Acetonide	Ranbaxy	Perrigo UK Finco
4/14/2015	Benztropine Mesylate	Benztropine Mesylate	USL Pharma	Nuvo Pharm
4/14/2015	Suprax	Cefixime	Lupin Pharms	Aurobindo Pharma
4/15/2015	Xanax	Alprazolam	Pharmacia and Upjohn	Natco Pharma
4/16/2015	Copaxone	Glatiramer Acetate	Teva Pharms USA	Sandoz
4/17/2015	Istalol	Timolol Maleate	Bausch and Lomb	Apotex
4/20/2015	Topicort	Desoximetasone	Taro	Perrigo New York
4/20/2015	Carac	Fluorouracil	Valeant Pharms North	Spear Pharms
4/20/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	Univ Utah Cylcotron
4/21/2015	Seasonale	Levonorgestrel / Ethinyl Estradiol	Teva Branded Pharm	Famy Care
4/22/2015	Ammonia N 13	Ammonia N 13	Feinstein	IBA Molecular North America
4/22/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Spectron MRC
4/22/2015	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	Spectron MRC
4/22/2015	Staxyn	Vardenafil Hydrochloride	Bayer Healthcare	Watson Labs
4/23/2015	Ammonia N 13	Ammonia N 13	Feinstein	Spectron MRC
4/23/2015	Xeloda	Capecitabine	Hoffmann La Roche	Accord Healthcare
4/23/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Methodist Hospital Research
4/23/2015	Zometa	Zoledronic Acid	Novartis	Fresenius Kabi USA
4/24/2015	Opana ER	Oxymorphone Hydrochloride	Endo Pharms	Sun Pharm Inds
4/24/2015	Qualaquin	Quinine Sulfate	Mutual Pharm	Lupin
4/24/2015	Prandin	Repaglinide	Novo Nordisk	Standard Chem Pharm
4/28/2015	Abilify	Aripiprazole	Otsuka	Teva Pharms USA
4/28/2015	Abilify	Aripiprazole	Otsuka	Teva Pharms USA
4/28/2015	Abilify	Aripiprazole	Otsuka	Teva Pharms USA
4/28/2015	Abilify	Aripiprazole	Otsuka	Torrent Pharms
4/28/2015	Abilify	Aripiprazole	Otsuka	Alembic Pharms
4/28/2015	Abilify	Aripiprazole	Otsuka	Alembic Pharms
4/28/2015	Abilify	Aripiprazole	Otsuka	Hetero Labs
4/29/2015	Zyprexa	Olanzapine	Lilly	Ivax Pharms Inc
4/29/2015	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Lehigh Valley	Novel Labs Inc
4/29/2015	Sanctura XR	Trospium Chloride	Allergan	Sandoz Inc
4/30/2015	Kariva	Kimidess	Barr	Vintage Pharms
5/1/2015	Ammonia N 13	Ammonia N 13	Feinstein	Biomedical Research Foundation
5/1/2015	Fludeoxyglucose F 18	Fludeoxyglucose F 18	Downstate Clinical	Biomedical Research Foundation
5/1/2015	Fludeoxyglucose F 18	Fludeoxyglucose F 18	Downstate Clinical	Biomedical Research Foundation
5/4/2015	Lotronex	Alosetron Hydrochloride	Prometheus Labs	Roxane
5/4/2015	Yasmin	Drospirenone / Ethinyl Estradiol	Bayer Healthcare	Famy Care
5/5/2015	Bimatoprost	Bimatoprost	Lupin	Alcon Research
5/7/2015	Hectorol	Doxercalciferol	Genzyme Corp	Akorn
5/8/2015	Temodar	Temozolomide	Merck Sharp Dohme	Amneal Pharms
5/11/2015	Ovcon-35	Norethindrone / Ethinyl Estradiol	Warner Chilcott	Famy Care
5/12/2015	Morphine Sulfate	Morphine Sulfate	Roxane	Tris Pharma
5/13/2015	Combivir	Lamivudine and Zidovudine	VIIV Healthcare	Strides Arcolab
5/14/2015	Lexapro	Escitalopram Oxalate	Forest Labs	Mylan Pharms
5/15/2015	Zithromax	Azithromycin	Pfizer	Lupin
5/15/2015	Kapvay	Clonidine Hydrochloride	Concordia Pharms	Actavis Elizabeth
5/18/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Teva Pharms USA
5/18/2015	Atelvia	Risedronate Sodium	Warner Chilcott	Teva Pharms USA
5/19/2015	Glucotrol XL	Glipizide	Pfizer	Mylan Pharms
5/20/2015	Ortho-Cept	Desogestrel / Ethinyl Estradiol	Janssen Pharms	Famy Care
5/21/2015	Casodex	Bicalutamide	AstraZeneca	Apotex
5/21/2015	Felodipine	Felodipine	Mylan	Orchid Healthcare
5/21/2015	Keppra XR	Levetiracetam	UCB	Prinston Inc
5/21/2015	Methotrexate Sodium	Methotrexate Sodium	Dava Pharms	Orion Corp Orion
5/21/2015	Morphine Sulfate	Morphine Sulfate	Hospira	Eurohealth International
5/21/2015	Vienva	Levonorgestrel / Ethinyl Estradiol	Watson Labs	Sandoz
5/22/2015	Soriatane	Acitretin	Stiefel Labs	Sigmapharm Labs
5/22/2015	Magnesium Sulfate	Magnesium Sulfate	Fresenius Kabi USA	Hospira
5/22/2015	Singulair	Montelukast Sodium	Merck	Hetero Labs
5/26/2015	Wellbutrin SR	Bupropion Hydrochloride	GlaxoSmithKline	Prinston
5/26/2015	Lexapro	Escitalopram Oxalate	Forest Labs	Antrim Pharms
5/27/2015	Mucinex D	Guaifenesin / Pseudoephedrine Hydrochloride (OTC)	Reckitt Benckiser	Actavis Labs FL
5/27/2015	Seasonique	Levonorgestrel / Ethinyl Estradiol	Teva Branded Pharm	Famy Care
5/27/2015	Tygacil	Tigecycline	PF Prism CV	Sandoz
5/28/2015	DDAVP	Desmopressin Acetate	Ferring Pharms	Glenmark Pharms
5/28/2015	Monodox	Doxycycline	Aqua Pharms	Novel Labs Inc
5/28/2015	Moxeza	Moxifloxacin Hydrochloride	Alcon Pharms	Lupin
5/28/2015	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Teva	Yaopharma
5/29/2015	Diuril	Chlorothiazide Sodium	Oak Pharms Akorn	Sagent Pharms
5/29/2015	Cleocin T	Clindamycin Phosphate	Pharmacia and Upjohn	Vintage Pharms
5/29/2015	Coly-Mycin M	Colistimethate Sodium	Par Sterile Products	Xellia Pharms APS
5/29/2015	Depakote ER	Divalproex Sodium	AbbVie	Amneal Pharms
5/29/2015	Plan B One-Step	Levonorgestrel (OTC)	Teva Branded Pharm	OC Pharma
5/29/2015	Flagyl	Metronidazole	GE Searle	Aurobindo Pharma
6/1/2015	Exforge HCT	Amlodipine Besylate / Valsartan / Hydrochlorothiazide	Novartis	Par Pharm
6/1/2015	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Vistapharm	Ani Pharms
6/2/2015	Celebrex	Celecoxib	GD Searle	Apotex
6/2/2015	Intuniv	Guanfacine Hydrochloride	Shire	Teva Pharms USA
6/2/2015	Intuniv	Guanfacine Hydrochloride	Shire	TWI Pharms
6/2/2015	Intuniv	Guanfacine Hydrochloride	Shire	Mylan Pharms
6/3/2015	Exforge HCT	Amlodipine Besylate / Valsartan / Hydrochlorothiazide	Novartis	Lupin
6/3/2015	Intuniv	Guanfacine Hydrochloride	Shire	Sandoz
6/3/2015	Zyvox	Linezolid	Pharmacia and Upjohn	Roxane
6/3/2015	Intermezzo	Zolpidem Tartrate	Purdue Pharma	Novel Labs
6/4/2015	Exforge HCT	Amlodipine Besylate / Valsartan / Hydrochlorothiazide	Novartis	Torrent Pharms
6/4/2015	Keppra	Levetiracetam	UCB	Pharm Assoc
6/4/2015	Lincocin	Lincomycin	Pharmacia and Upjohn	X-Gen Pharms Inc
6/4/2015	Restoril	Temazepam	Mallinckrodt	Vintage Pharms
6/5/2015	Aricept	Donepezil Hydrochloride	Eisai	Sun Pharm Inds
6/5/2015	Integrilin	Eptifibatide	Schering	Teva Pharms USA
6/5/2015	Plan B One-Step	Levonorgestrel (OTC)	Teva Branded Pharm	Lotus Pharm
6/9/2015	Dovonex	Calcipotriene	Leo Pharma	Glenmark Pharms
6/9/2015	Celebrex	Celecoxib	GD Searle	Lupin
6/9/2015	Oxsoralen-Ultra	Methoxsalen	Dow Pharm	Actavis
6/9/2015	Metadate ER	Methylphenidate Hydrochloride	UCB	Abhai
6/9/2015	Diovan	Valsartan	Novartis	Prinston
6/10/2015	Casodex	Bicalutamide	AstraZeneca	Stason Pharms
6/10/2015	Buprenorphine Hydrochloride	Buprenorphine Hydrochloride	Roxane	Sandoz
6/10/2015	Lithobid	Lithium Carbonate	Ani Pharms	Alembic Pharms
6/10/2015	Dilantin	Phenytoin Sodium	Parke Davis	Aurobindo Pharma
6/10/2015	Exelon	Rivastigmine Tartrate	Novartis	Orchid Healthcare
6/12/2015	Ziana	Clindamycin Phosphate / Tretinoin	Medicis	Actavis Mid Atlantic
6/12/2015	Topicort	Desoximetasone	Taro	Versapharm
6/12/2015	Integrilin	Eptifibatide	Schering	Teva Pharms USA
6/12/2015	Seasonale	Levonorgestrel / Ethinyl Estradiol	Teva Branded Pharm	Glenmark Pharms
6/15/2015	Factive	Gemifloxacin Mesylate	LG Life Sciences	Orchid Healthcare
6/16/2015	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Vistapharm	Wockhardt Bio
6/17/2015	Loseasonique	Levonorgestrel / Ethinyl Estradiol	Teva Branded Pharm	Famy Care
6/18/2015	Macrodantin	Nitrofurantoin	Alvogen	Actavis Labs FL
6/19/2015	Acetadote	Acetylcysteine	Cumberland Pharms	Mylan Institutional
6/19/2015	Zithromax	Azithromycin	Pfizer	Aurobindo Pharma
6/19/2015	Acanya	Clindamycin Phosphate / Benzoyl Peroxide	Dow Pharm	Actavis Labs UT
6/19/2015	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Mylan Pharms	Orit Labs
6/19/2015	Comtan	Entacapone	Orion Pharma	Aurobindo Pharma
6/19/2015	Levaquin	Levofloxacin	Janssen Pharms	Jubilant Generics
6/22/2015	Mestinon	Pyridostigmine Bromide	Valeant Pharms	Zydus Pharms USA
6/23/2015	Ammonia N 13	Ammonia N 13	Feinstein	Central Radiopharm
6/23/2015	Fludeoxyglucose F 18	Fludeoxyglucose F 18	Downstate Clinical	Triad Isotopes
6/23/2015	Fludeoxyglucose F 18	Fludeoxyglucose F 18	Downstate Clinical	Univ Utah Cyclotron
6/25/2015	Derma-Smoothe/FS	Fluocinolone Acetonide	Hill Dermac	Versapharm
6/26/2015	Zetia	Ezetimibe	MSD International	Glenmark Pharms
6/26/2015	Xyzal	Levocetirizine Dihydrochloride	UCB	Sun Pharm Inds
6/26/2015	Mestinon	Pyridostigmine Bromide	Valeant Pharms	Alvogen
6/29/2015	Phoslo Gelcaps	Calcium Acetate	Fresenius Medical	Zydus Pharms USA
6/29/2015	Pristiq	Desvenlafaxine Succinate	Wyeth Pharms	Alembic Pharms
6/29/2015	Pristiq	Desvenlafaxine Succinate	Wyeth Pharms	Sandoz
6/29/2015	Pristiq	Desvenlafaxine Succinate	Wyeth Pharms	Mylan Pharms
6/29/2015	Pristiq	Desvenlafaxine Succinate	Wyeth Pharms	Lupin
6/29/2015	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Akorn	X-Gen Pharms
6/29/2015	Ortho Tricylen Lo	Norgestimate / Ethinyl Estradiol	Janssen Pharms	Sandoz