ANDA Approvals

Spring 2015

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
1/5/2015	Diovan	valsartan	Novartis	IVAX Pharms.
1/5/2015	Diovan	valsartan	Novartis	Watson Labs.
1/5/2015	Diovan	valsartan	Novartis	Mylan
1/5/2015	Diovan	valsartan	Novartis	Alembic Pharms.
1/5/2015	Diovan	valsartan	Novartis	Lupin
1/5/2015	Diovan	valsartan	Novartis	Aurobindo Pharma
1/5/2015	Diovan	valsartan	Novartis	Torrent Pharms.
1/5/2015	Diovan	valsartan	Novartis	Hetero Labs.
1/5/2015	Diovan	valsartan	Novartis	Jubilant Generics
1/7/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Downstate Clinical	NCM USA Bronx
1/8/2015	Levaquin	levofloxacin	Janssen Pharms.	Hetero Labs.
1/12/2015	Risperdal	risperidone	Janssen Pharms.	Silarx Pharms.
1/15/2015	Norvir	ritonavir	AbbVie	Roxane
1/16/2015	Benzonatate	benzonatate	The Pharma Network	Apotex
1/22/2015	Evista	raloxifene hydrochloride	Eli Lilly	Watson Labs.
1/22/2015	Eliphos	calcium acetate	Cypress Pharm.	Zydus Pharms.
1/26/2015	Nexium	esomeprazole magnesium	AstraZeneca	Ivax Sub Teva Pharms.
1/27/2015	Vituz	hydrocodone bitartrate / chlorpheniramine maleate	Cypress Pharm.	Tris Pharma
1/28/2015	Vancocin Hydrochloride	vancomycin hydrochloride	Ani Pharms.	Lupin
1/29/2015	Allegra-D	fexofenadine hydrochloride / pseudoephedrine hydrochloride	Sanofi Aventis	Sun Pharma Global
1/30/2015	Transderm Scop	scopolamine	Novartis	Perrigo
1/30/2015	Namenda	memantine hydrochloride	Forest Labs.	Mylan
1/30/2015	Lunesta	eszopiclone	Sunovion Pharms.	MacLeods Pharms.
1/30/2015	Aricept	donepezil hydrochloride	Eisai	Hetero Labs.
2/4/2015	Fludeoxyglucose F18	Fludeoxyglucose F18	Downstate Clinical	Univ. North Dakota
2/4/2015	Ammonia N13	Ammonia N 13	Feinstein	NCM USA Bronx
2/10/2015	Bromday	bromfenac sodium	Bausch and Lomb Inc.	Paddock
2/11/2015	Celebrex	celecoxib	GD Searle	Mylan
2/11/2015	Celebrex	celecoxib	GD Searle	Watson Labs.
2/13/2015	Xyzal	levocetirizine dihydrochloride	UCB	Apotex
2/18/2015	Larin 24 FE	norethindrone acetate / ethinyl estradiol / ferrous fumarate	Amneal Pharms.	Novast Labs.
2/19/2015	Buprenorphine Hydrochloride	buprenorphine hydrochloride	Roxane	Actavis Elizabeth
2/19/2015	Children's Cetirizine Hydrochloride Allergy (Over-the-Counter)	Children's Cetirizine Hydrochloride Allergy	Sandoz	Jubilant Generics
2/19/2015	Children's Cetirizine Hydrochloride Allergy (Over-the-Counter)	Children's Cetirizine Hydrochloride Hives Relief	Sandoz	Jubilant Generics
2/19/2015	Loestrin	norethindrone acetate / ethinyl estradiol	Warner Chilcott	Famy Care
2/20/2015	Brevibloc	esmolol hydrochloride	Baxter Healthcare	Luitpold
2/20/2015	Loestrin FE 1.5/30	norethindrone acetate / ethinyl estradiol	Warner Chilcott	Famy Care
2/20/2015	Lumigan	bimatoprost	Allergan	Lupin
2/23/2015	Detrol	tolterodine tartrate	Pharmacia and Upjohn	Ivax Sub Teva Pharms.
2/23/2015	Seasonique	levonorgestrel / ethinyl estradiol and ethinyl estradiol extended-cycle oral contraceptive tablets	Teva	Glenmark Generics
2/23/2015	Avapro	irbesartan	Sanofi Aventis	Jubilant Generics
2/24/2015	Glyset	miglitol	Pharmacia and Upjohn	Orient Pharma
2/25/2015	Keppra XR	levetiracetam	UCB Inc	Apotex
2/25/2015	Methylin	methylphenidate hydrochloride	Mallinckrodt	Novel Labs.
2/27/2015	Skelaxin	metaxalone	King Pharms.	Corepharma
3/4/2015	Antabuse	disulfiram	Odyssey Pharms.	Mylan
3/6/2015	Vigamox	moxifloxacin hydrochloride	Alcon Pharms.	Watson Labs.
3/9/2015	Fusilev	levoleucovorin calcium	Spectrum Pharms.	Sandoz
3/12/2015	Singulair	montelukast sodium	Merck	MacLeods Pharms.
3/13/2015	Enablex	darifenacin hydrobromide	Warner Chilcott	Anchen Pharms.
3/16/2015	Celebrex	celecoxib	GD Searle	Lupin
3/16/2015	Prozac	fluoxetine hydrochloride	Eli Lilly	Sciegen Pharms.
3/18/2015	Viread	tenofovir disoproxil fumarate	Gilead Sciences	Teva
3/19/2015	Zometa	zoledronic acid	Novartis	Hospira
3/26/2015	Tasmar	tolcapone	Valeant Pharms.	Par
3/30/2015	Exforge	amlodipine besylate / valsartan	Novartis	Lupin
3/30/2015	Exforge	amlodipine besylate / valsartan	Novartis	Matrix Labs.
3/30/2015	Exforge	amlodipine besylate / valsartan	Novartis	Torrent Pharms.
3/30/2015	Exforge	amlodipine besylate / valsartan	Novartis	Novel Labs.