ANDA Approvals

Winter 2013

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
10/9/2013	Levonorgestrel / Ethinyl Estradiol	Levonorgestrel / Ethinyl Estradiol	Watson Labs	Famy Care
10/9/2013	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA	Emcure Pharms
10/9/2013	Tindamax	Tinidazole	Mission Pharma	Unique Pharm Labs
10/10/2013	Tobi	Tobramycin	Novartis Pharms	Teva
10/10/2013	Geodon	Ziprasidone Hydrochloride	Pfizer	Mylan
10/11/2013	Penicillin V Potassium	Penicillin V Potassium	Sandoz	Hikma Pharms
10/11/2013	Wellbutrin SR	Bupropion Hydrochloride	GlaxoSmithKline	Jubilant Life
10/11/2013	Zyban	Bupropion Hydrochloride	GlaxoSmithKline	Jubilant Life
10/11/2013	Acyclovir Sodium	Acyclovir Sodium	Fresenius Kabi USA	Aurobindo Pharma
10/15/2013	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Hikma Maple	Emcure Pharms
10/17/2013	Precose	Acarbose	Bayer Healthcare	Virtus Pharm
10/17/2013	Lamictal HR	Lamotrigine	GlaxoSmithKline	Actavis Elizabeth
10/21/2013	Norvasc	Amlodipine Besylate	Pfizer	Unichem Labs
10/28/2013	Solaraze	Diclofenac Sodium	Fougera Pharms	Tolmar
10/29/2013	Duraclon	Clonidine Hydrochloride	Mylan	Exela Pharma SCS
10/29/2013	Zestril	Lusinopril	Astrazeneca	Invagen Pharms
10/29/2013	Zovirax	Acyclovir Sodium	GlaxoSmithKline	Hetero Labs
10/31/2013	Detrol LA	Tolterodine Tartrate	Mylan	Mylan
10/31/2013	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA/Hospira	Emcure Pharms
10/31/2013	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi USA/Hospira	Emcure Pharms
11/5/2013	Propecia	Finasteride	Merck	Teva
11/5/2013	Propecia	Finasteride	Merck	Mylan
11/5/2013	Propecia	Finasteride	Merck	Actavis Totowa
11/5/2013	Propecia	Finasteride	Merck	Accord Healthcare
11/5/2013	Propecia	Finasteride	Merck	Aurobindo Pharma
11/5/2013	Marcaine Hydrochloride / Marcaine Hydrochloride Preservative Free	Bupivacaine Hydrochloride Preservative Free	Hospira	Aurobindo Pharma
11/6/2013	Loestrin	Norethindrone Acetate / Ethinyl Estradiol	Warner Chilcott	Famy Care
11/6/2013	Lopressor HCT	Metoprolol Tartrate / Hydrochlorothiazide	US Pharms	Alembic Pharms
11/8/2013	Aciphex	Rabeprazole Sodium	Eisai	Teva
11/8/2013	Aciphex	Rabeprazole Sodium	Eisai	Dr Reddy's Labs
11/8/2013	Aciphex	Rabeprazole Sodium	Eisai	Mylan
11/8/2013	Aciphex	Rabeprazole Sodium	Eisai	Lupin
11/8/2013	Aciphex	Rabeprazole Sodium	Eisai	Kremers Urban
11/8/2013	Terbutaline Sulfate	Terbutaline Sulfate	Bedford	United Biomedical
11/8/2013	Felodipine	Felodipine	Mylan	Heritage Pharms
11/8/2013	Aciphex	Rabeprazole Sodium	Eisai	Torrent Pharms
11/12/2013	Octreotide Acetate (Preservative Free) / Sandostatin	Octreotide Acetate (Preservative Free)	Bedford/Novartis	Sagent Pharms
11/12/2013	Octreotide Acetate / Sandostatin	Octreotide Acetate	Bedford/Novartis	Sagent Pharms
11/12/2013	Methylin	Methylphenidate Hydrochloride	Mallinckrodt	Caraco
11/13/2013	Lamictal XR	Lamotrigine	GlaxoSmithKline	Actavis Elizabeth
11/14/2013	Loestrin	Norethindrone Acetate / Ethinyl Estradiol	Warner Chilcott	Famy Care
11/15/2013	Zovirax	Acyclovir	GlaxoSmithKline	Cadila Pharms
11/18/2013	Focalin XR	Dexmethylphenidate Hydrochloride	Novartis	Intellipharmaceutics
11/18/2013	Luvox CR	Fluvoxamine Maleate	Jazz Pharms	Actavis Elizabeth
11/18/2013	Campral	Acamprosate Calcium	Forest Labs	Barr Labs Div Teva
11/19/2013	Focalin XR	Dexmethylphenidate Hydrochloride	Novartis	Teva
11/19/2013	Focalin XR	Dexmethylphenidate Hydrochloride	Novartis	Teva
11/21/2013	Focalin XR	Dexmethylphenidate Hydrochloride	Novartis	Watson Labs
11/21/2013	Prandin	Repaglinide	Novo Nordisk	Sandoz
11/22/2013	Levaquin	Levofloxacin	Janssen Pharms	Watson Labs
11/25/2013	Topamax	Torpiramate	Janssen Pharms	Hikma Pharms
11/25/2013	Amiodarone Hydrchloride	Amiodarone Hydrochloride	Akorn/Fresenius Kabi USA/Gland Pharma/Hospira/Mylan	Hospira
11/25/2013	Amiodarone Hydrchloride	Amiodarone Hydrochloride	Akorn/Fresenius Kabi USA/Gland Pharma/Hospira/Mylan	Hospira
11/26/2013	Seroquel	Quetiapine Fumarate	Astrazeneca	Jubilant Life
11/26/2013	Maxalt	Rizatriptan Benzoate	Merck	Emcure Pharms
11/26/2013	Retrovir	Zidovudine	VIIV Healthcare	Liaoning Chengda
11/27/2013	Ketorolac Tromethamine	Ketorolac Tromethamine	Bedford	Sagent Pharms
11/27/2013	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex	Torrent Pharms
11/27/2013	Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate	Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate	Barr	Aurolife Pharma
11/29/2013	Caduet	Amlodipine Besylate / Atorvastatin Calcium	Pfizer	Mylan
12/2/2013	Amoxicillin / Clavulanate Potassium	Amoxicillin / Clavulanate Potassium	Teva	Wockhardt
12/2/2013	Cabergoline	Cabergoline	Par Pharms	Mylan
12/4/2013	Trusopt	Dorzolamide Hydrochloride	Merck	Zach Systems
12/4/2013	Cosopt	Dorzolamide Hydrochloride / Timolol Maleate	Oak Pharms Akorn	Zach Systems
12/4/2013	Loestrin 21	Ethinyl Estradiol / Norethindrone acetate	Warner Chilcott	Novast Labs
12/5/2013	Trizivir	Abacavir Sulfate / Lamivudine / Zidovudine	VIIV Healthcare	Lupin
12/9/2013	Indomethacin	Indomethacin	Sandoz	Watson Labs
12/9/2013	Ammonia N 13	Ammonia N 13	Feinstein	Kreitchman Pet Ctr
12/11/2013	Cymbalta	Duloxetine Hydrochloride	Lilly	Lupin
12/11/2013	Cymbalta	Duloxetine Hydrochloride	Lilly	Dr Reddy's Labs
12/11/2013	Cymbalta	Duloxetine Hydrochloride	Lilly	Sun Pharma Global
12/11/2013	Cymbalta	Duloxetine Hydrochloride	Lilly	Torrent Pharms
12/11/2013	Cymbalta	Duloxetine Hydrochloride	Lilly	Aurobindo Pharma
12/11/2013	Cymbalta	Duloxetine Hydrochloride	Lilly	Teva
12/12/2013	Amikacin Sulfate	Amikacin Sulfate	Bedford	Emcure Pharms
12/13/2013	Xopenex	Levalbuterol Hydrochloride	Sunovion	Cipla
12/13/2013	Felodipine	Felodipine	Mylan	Ranbaxy Labs
12/13/2013	Bacitracin	Bacitracin	Perrigo	Akorn
12/17/2013	Cymbalta	Duloxetine Hydrochloride	Lilly	Actavis Elizabeth
12/20/2013	Totacillin N	Ampicillin Sodium	GlaxoSmithKline	Istituto Bio Ita Spa
12/20/2013	Reglan	Metoclopramide	Baxter Healthcare	Emcure Pharms
12/23/2013	DDAVP	Desmopressin Acetate	Sanofi Aventis	Sun Pharma Global
12/23/2013	Sodium Fluoride F 18	Sodium Fluoride F-18	NIH NCI DCTD	Univ TX MD Anderson
12/23/2013	Lamictal XR	Lamotrigine	GlaxoSmithKline	Torrent Pharms
12/23/2013	Fludeoxyglucose F18	Fludeoxyglucose F-18	Feinstein	WI Medcl Cyclotron
12/26/2013	Percocet	Oxycodone / Acetaminophen	Vintage Parms	Caraco
12/26/2013	Patossium Chloride	Potasium Chloride	Watson Labs	Anchen Pharms
12/30/2013	Lotrel	Amiodipine Besylate / Benazepril Hydrochloride	Novartis	Apotex