ANDA Approvals

Summer 2013

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
4/2/2013	Zithromax	Azithromycin	Pfizer	Sun Pharm Indus
4/3/2013	Ampicillin Sodium	Ampicillin Sodium	Sandoz	ACS Dobfar Spa
4/3/2013	Ampicillin Sodium	Ampicillin Sodium	Sandoz	ACS Dobfar Spa
4/3/2013	Lunesta	Eszopiclone	Sunovion Pharms Inc	Sun Pharma Global
4/3/2013	Zovirax	Acyclovir	Valeant Int'l	Mylan Pharms
4/4/2013	Soriatane	Acitretin	Stiefel Labs	Barr Labs
4/4/2013	Gastrocrom	Cromolyn Sodium	Meda Pharms	Micro Labs
4/4/2013	Soriatane	Acitretin	Stiefel Labs	Barr Labs
4/4/2013	Cleocin Phosphate in 5% Dextrose in Plastic Container	Clindamycin Phosphate in 5% Dextrose in Plastic Container	Pharmacia and Upjohn	Akorn
4/5/2013	Lipitor	Atorvastatin Calcium	Pfizer	Kudco Ireland
4/5/2013	Reclast	Zoledronic Acid	Novartis	Hospira
4/8/2013	Risperdal	Risperidone	Janssen Pharms	Sun Pharm Indus
4/10/2013	Seasonique	Daysee	Teva Branded Pharm	Lupin
4/10/2013	Orapred ODT	Prednisolone Sodium Phosphate	Shionogi	Mylan Pharms
4/12/2013	Percocet	Oxycodone / Acetaminophen	Vintage Pharms	Actavis Elizabeth
4/15/2013	Acetaminophen and Codeine Phosphate; Tylenol w/Codeine No. 3; Acetaminophen and Codeine Phosphate	Acetaminophen / Codeine Phosphate	Mallinckrodt; Janssen Pharms; Teva	Aurolife Pharma
4/16/2013	Actoplus Met	Pioglitazone Hydrochloride / Metformin Hydrochloride	Takeda Pharms USA	Sandoz
4/19/2013	Zegerid	Omeprazole / Sodium Bicarbonate	Santarus	Par Pharm
4/19/2013	Reglan	Metoclopramide Hydrochloride	Baxter Healthcare	BD RX
4/19/2013	Diovan HCT	Valsartan / Hydrochlorothiazide	Novartis	MacLeods Pharms
4/23/2013	Luvox CR	Fluvoxamine Maleate	Jazz Pharms	Actavis Elizabeth
4/23/2013	Imitrex	Sumatriptan Succinate	GlaxoSmithKline	Aurobindo Pharma
4/24/2013	Promethazine Hydrochloride and Codeine Phosphate	Promethazine Hydrochloride / Codeine Phosphate	Actavis Mid Atlantic	Amneal Pharms
4/24/2013	Ortho-Novum 7/7/7-28	Primella 7/7/7	Janssen Pharms	Lupin
4/24/2013	Ortho-Novum 1/35-28	Primella 1/35	Janssen Pharms	Lupin
4/25/2013	Duricef	Cefadroxil	Warner Chilcott	Aurobindo Pharma
4/25/2013	Opana	Oxymorphone Hydrochloride	Endo Pharms	Mallinckrodt Inc
4/25/2013	Procardia	Nifedipine	Pfizer	Emcure Pharms USA
4/26/2013	Xopenex	Levalbuterol Hydrochloride	Sunovion	Teva Pharms USA
4/29/2013	Adderall XR 30	Amphetamine / Dextroamphetamine	Shire	Teva Pharms USA
4/29/2013	Lopressor	Metoprolol Tartrate	Novartis	Claris LifeSciences
4/29/2013	Norvasc	Amlodipine Besylate	Pfizer	Accord Healthcare
4/29/2013	Ocuflox	Ofloxacin	Allergan	Altaire Pharms
4/29/2013	Accupril	Quinapril Hydrochloride	Pfizer Pharms	Aurobindo Pharma
4/30/2013	Doryx	Doxycycline Hyclate	Mayne Pharma	Heritage Pharms
4/30/2013	Cleocin	Clindamycin Palmitate Hydrochloride	Pharmacia and Upjohn	Aurobindo Pharma
4/30/2013	Flomax	Tamsulosin Hydrochloride	Boehringer Ingelheim	Aurobindo Pharma
5/3/2013	Atacand	Candesartan Cilexetil	AstraZeneca	Sandoz
5/3/2013	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Pliva	Strides Arcolab
5/6/2013	Zyloprim	Allopurinol	Prometheus Labs	Accord Healthcare
5/7/2013	Gemzar	Gemcitabine Hydrochloride	Eli Lilly	Sagent Pharms
5/7/2013	Gemzar	Gemcitabine Hydrochloride	Eli Lilly	Pharmaforce
5/7/2013	Gemzar	Gemcitabine Hydrochloride	Eli Lilly	Jiangsu Hansoh Pharm
5/7/2013	Zometa	Zoledronic Acid	Novartis	Pharms
5/7/2013	Gemcitabine Hydrochloride	Gemcitabine Hydrochloride	Hospira	Dr Reddy's Labs
5/8/2013	Triaminolone Acetonide	Triamcinolone Acetonide	Morton Grove / Wockhardt	Versapharm
5/9/2013	Arthrotec	Diclofenac Sodium / Misoprostol	GD Searle	Sandoz
5/10/2013	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate / Acetaminophen	Mikart	PAI
5/13/2013	Minocycline Hydrochloride	Minocycline Hydrochloride	Teva	Caraco
5/13/2013	Comtan	Entacapone	Orion Pharma	Mylan Pharms
5/14/2013	Zomig	Zolmitriptan	IPR	Glenmark Generics
5/14/2013	Zomig	Zolmitriptan	IPR	Apotex
5/14/2013	Zomig-ZMT	Zolmitriptan	AstraZeneca	Apotex
5/14/2013	Zomig	Zolmitriptan	AstraZeneca	Glenmark Generics
5/14/2013	Zomig	Zolmitriptan	IPR	Mylan Pharms
5/15/2013	Zomig-ZMT	Zolmitriptan	AstraZeneca	Zydus Pharms USA
5/16/2013	Exelon	Rivastigmine Tartrate	Novartis	Apotex
5/16/2013	Ultram	Tramadol Hydrochloride	Janssen Pharms	Accord Healthcare
5/16/2013	Femara	Letrozole	Novartis	Jiangsu Hengrui Med
5/21/2013	Imitrex	Sumatriptan Succinate	GlaxoSmithKline	Hikma Pharms
5/24/2013	Rocaltrol	Calcitriol	Validus Pharms	Banner Pharmacaps
5/24/2013	Sanctura XR	Trospium Chloride	Allergan	Paddock
5/28/2013	Plavix	Clopidogrel Bisulfate	Sanofi Aventis US	Actavis Totowa
5/28/2013	Vicoprofen	Hydrocodone Bitartrate / Ibuprofen	Abbvie	Sun Pharm Indus
5/28/2013	Vfend	Voriconazole	Pfizer	Mylan Pharms
5/28/2013	Metoprolol Tartrate	Metoprolol Tartrate	Mylan	Alembic Pharms
5/29/2013	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Outlook Pharms	Tris Pharma
5/30/2013	Avodart	Dutasteride	GlaxoSmithKline	Banner Pharmacaps
6/3/2013	Vistaril	Hydroxyzine Pamoate	Pfizer	Emcure Pharms USA
6/3/2013	Depo-Testosterone	Testosterone Cypionate	Pharmacia and Upjohn	Sun Pharm Indus
6/3/2013	Kadian	Morphine Sulfate	Watson Labs	Upsher Smith
6/3/2013	Zometa	Zoledronic Acid	Novartis	Hikma Farmaceutica
6/3/2013	Atacand HCT	Candesartan Cilexetil / Hydrochlorothiazide	AstraZeneca	Apotex
6/3/2013	Atacand HCT	Candesartan Cilexetil / Hydrochlorothiazide	AstraZeneca	Dr Reddy's Labs
6/5/2013	Levaquin	Levofloxacin	Janssen Pharms	Claris LifeSciences
6/10/2013	Biaxin	Clarithromycin	Abbvie	Allied Pharma
6/12/2013	Lexapro	Escitalopram Oxalate	Forest Labs	Silarx Pharms
6/12/2013	Micronor	Norethindrone	Janssen Pharms	Famy Care
6/13/2013	Cellcept	Mycophenolate Mofetil	Roche Palo	Alkem Labs
6/13/2013	Catapres	Clonidine Hydrochloride	Boehringer Ingelheim	Carlsbad
6/14/2013	Lamictal	Lamotrigine	GlaxoSmithKline	Alkem Labs
6/14/2013	Cyklokapron	Tranexamic Acid	Pharmacia and Upjohn	Custopharm
6/17/2013	Lamictal XR	Lamotrigine	GlaxoSmithKline	Handa Pharms
6/18/2013	Rilutek	Riluzole	Covis Pharma	Apotex
6/18/2013	Rilutek	Riluzole	Covis Pharma	Glenmark Generics
6/18/2013	Rilutek	Riluzole	Covis Pharma	Sun Pharm Indus
6/19/2013	Levaquin in Dextrose 5% in Plastic Container	Levofloxacin in Dextrose 5% in Plastic Container	Janssen Pharms	Fresenius Kabi USA
6/19/2013	Lamictal XR	Lamotrigine	GlaxoSmithKline	Dr Reddy's Labs
6/21/2013	Carbatrol	Carbamazepine	Shire	Taro
6/21/2013	Skelaxin	Metaxalone	King Pharms	Amneal Pharms
6/26/2013	Keppra	Levetiracetam	UCB	Sagent Pharms
6/26/2013	Hycamtin	Topotecan Hydrochloride	GlaxoSmithKline	Accord Healthcare
6/27/2013	Coumadin	Warfarin Sodium	Bristol-Myers Squibb	IPCA Labs
6/27/2013	Fludeoxyglucose F18	Fludeoxyglucose F18	Weill Medical College	UCLA Biomedical
6/27/2013	Ammonia N 13	Ammonia N 13	Feinstein	UCLA Biomedical
6/28/2013	Tofranil-PM	Imipramine Pamoate	Mallinckrodt	Mylan Pharms
6/28/2013	FLUORINE F-18	Sodium Fluoride F-18	GE Healthcare	MCPRF