ANDA Approvals

Winter 2014

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
10/2/2014	Adenoscan	Adenosine	Astellas	Akorn
10/6/2014	PhosLo Gelcaps	Calcium Acetate	Fresenius Medical	Amneal Pharms
10/8/2014	Patanase	Olopatadine Hydrochloride	Alcon Pharms	Apotex
10/15/2014	Ritalin LA	Methylphenidate Hydrochloride	Novartis	Barr Labs
10/21/2014	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Global Isotopes
10/21/2014	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	Global Isotopes
10/23/2014	Ammonia N 13	Ammonia N 13	Feinstein	Global Isotopes
10/24/2014	Astelin	Azelastine Hydrochloride	Meda Pharms	Roxane
10/24/2014	Opana ER	Oxymorphone Hydrochloride Extended-Release	Endo Pharms	Par Pharm
10/24/2014	Stromectol	Ivermectin	Merck Sharp Dohme	Edenbridge Pharms
10/27/2014	Differin	Adapalene	Galderma Labs	Actavis Mid Atlantic
10/27/2014	Rapamune	Sirolimus	PF Prism CV	Dr Reddy's Labs
10/27/2014	Soma	Carisoprodol	Meda Pharms	Orient Pharma
10/27/2014	Viramune XR	Nevirapine	Boehringer Ingelheim	Mylan
10/28/2014	Soma	Carisoprodol	Meda Pharms	Natco Pharma
10/28/2014	Metoprolol Tartrate	Metoprolol Tartrate	Mylan	Rubicon Res PVT
10/28/2014	Seroquel	Quetiapine Fumarate	AstraZeneca	Alembic Pharms
10/28/2014	Rezira	Hydrocodone Bitartrate / Pseudoephedrine Hydrochloride	Cypress Pharm	Tris Pharma
10/28/2014	Mirapex	Pramipexole Dihydrochloride	Boehringer Ingelheim	Sciegen Pharms
10/29/2014	Oxytocin / Oxytocin /Pitocin	Oxytocin	Fresenius Kabi USA / Hikma Maple / Par Sterile Products	Sagent Pharms
10/29/2014	Femara	Letrozole	Novartis Pharms	Lannett Holdings
10/29/2014	Celebrex	Celecoxib	GD Searle	Lupin
10/29/2014	Isoniazid	Isoniazid	Sandoz	ThePharmaNetwork
10/29/2014	Aricept	Donepezil Hydrochloride	Eisai	TWI Pharms
10/29/2014	Aricept	Donepezil Hydrochloride	Eisai	Sciegen Pharms
10/29/2014	Zosyn	Piperacillin / Tazobactam	Wyeth	Sandoz
10/29/2014	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Trustees Univ PA
10/29/2014	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Children's Hospital MI
10/29/2014	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	SPDC
10/29/2014	Sodium Fluoride F-18	Sodium Fluoride F18	Houston Cyclotron	Essential Isotopes
10/30/2014	Myfortic	Mycophenolic Acid	Novartis	Teva Pharms USA
10/30/2014	Loestrin 24 FE	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	Warner Chilcott	Famy Care
10/30/2014	Singulair	Montelukast Sodium	Merck	Unimark Remedies
10/30/2014	Singulair	Montelukast Sodium	Merck	Unimark Remedies
10/30/2014	Ammonia N 13	Ammonia N 13	Feinstein	Brigham Women's Hosp
10/30/2014	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Brigham Women's Hosp
10/30/2014	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Hot Shots NM
10/31/2014	Prilosec	Omeprazole	AstraZeneca	Glenmark Generics
10/31/2014	Antara (Micronized)	Fenofibrate	Lupin Atlantis	Ranbaxy Labs
10/31/2014	Desowen	Desonide	Galderma Labs	Taro
10/31/2014	Luvox CR	Fluvoxamine Maleate	Jazz Pharms	Torrent Pharms
10/31/2014	Epivir	Lamivudine	ViiV Healthcare	Silarx Pharms
10/31/2014	Paxil	Paroxetine	Apotex Technologies	Prinston
10/31/2014	Wellbutrin SR	Bupropion Hydrochloride	GlaxoSmithKline	Torrent Pharms
10/31/2014	Cyclophosphamide / Cytoxan	Cyclophosphamide	Baxter Healthcare	Jiangsu Hengrui Med
11/3/2014	Micardis	Telmisartan	Boehringer Ingelheim	Sandoz
11/4/2014	Valcyte	Valganciclovir Hydrochloride	Hoffmann LA Roche	Endo Pharms
11/4/2014	Valcyte	Valganciclovir Hydrochloride	Hoffmann LA Roche	Dr Reddy's Labs
11/5/2014	Taxotere	Docetaxel	Sanofi Aventis US	Dr Reddy's Labs
11/7/2014	Zoloft	Sertraline Hydrochloride	Pfizer	Accord Healthcare
11/13/2014	Zomig	Zolmitriptan	IPR	Sun Pharma Global
11/14/2014	Cellcept	Mycophenolate Mofetil	Roche Palo	Alkem Labs
11/18/2014	Allegra-D 12	Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride	Sanofi Aventis US	Dr Reddy's Labs
11/18/2014	Brimonidine Tartrate	Brimonidine Tartrate	Bausch and Lomb	Indoco Remedies
11/19/2014	Yasmin	Drospirenone / Ethinyl Estradiol	Bayer Healthcare	Novast Labs
11/19/2014	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	The Feinstein Inst
11/20/2014	Propecia	Finasteride	Merck	Cipla
11/20/2014	Zomig	Zolmitriptan	IPR	Jubilant Generics
11/20/2014	Ammonia N 13	Ammonia N 13	Feinstein	MIPS CRF
11/24/2014	Zometa	Zoledronic Acid	Novartis	Sagent Pharms
11/24/2014	Pennsaid	Diclofenac Sodium	Mallinckrodt	Paddock
11/25/2014	Zocor	Simvastatin	Merck	Hetero Labs
11/25/2014	Precedex	Dexmedetomidine Hydrochloride	Hospira	Akorn
11/25/2014	Pennsaid	Diclofenac Sodium	Mallinckrodt	Watson Labs
11/26/2014	Revatio	Sildenafil Citrate	Pfizer	Hetero Labs
11/26/2014	Pennsaid	Diclofenac Sodium	Mallinckrodt	Taro
11/26/2014	Zutripro	Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride	Cypress Pharm	Tris Pharma
11/26/2014	Synalgos-DC-A	Acetaminophen / Caffeine / Dihydrocodeine Bitartrate	Leitner Pharms	Wraser Pharms
11/28/2014	Dilantin	Phenytoin	Pfizer	Corepharma
11/28/2014	Kayexalate	Sodium Polystyrene Sulfonate	Covis Pharma	Nuvo Pharm
11/28/2014	Sodium Fluoride F-18	Sodium Fluoride F-18	Houston Cyclotron	NCM USA Bronx
12/1/2014	Latisse	Bimatoprost	Allergan	Apotex
12/2/2014	Protonix	Pantoprazole Sodium	Wyeth Pharms	Orchid Healthcare
12/4/2014	Mirapex	Pramipexole Dihydrochloride	Boehringer Ingelheim	Sandoz
12/5/2014	Phentermine Hydrochloride	Phentermine Hydrochloride	Sandoz	Ken Lifescience
12/8/2014	Nordette-28	Levonorgestrel / Ethinyl Estradiol	Teva Branded Pharm	Haupt Pharma
12/8/2014	Levonorgestrel / Ethinyl Estradiol	Levonorgestrel / Ethinyl Estradiol	Watson Labs	Famy Care
12/12/2014	Rocaltrol	Calcitriol	Validus Pharms	Strides Arcolab
12/12/2014	Taclonex	Calcipotriene / Betamethasone Dipropionate	Leo Pharma	Perrigo Israel
12/15/2014	Cellcept	Mycophenolate Mofetil	Roche Palo	Cadista Pharms
12/15/2014	Cellcept	Mycophenolate Mofetil	Roche Palo	Cadista Pharms
12/15/2014	Opana	Oxymorphone Hydrochloride	Endo Pharms	Corepharma
12/18/2014	Wellbutrin XL	Bupropion Hydrochloride	Valeant	Sun Pharma Global
12/18/2014	Cosopt	Dorzolamide Hydrochloride / Timolol Maleate	Oak Pharms	Lannett Holdings
12/18/2014	Roxicet	Oxycodone Hydrochloride / Acetaminophen	Roxane	Vintage Pharms
12/18/2014	Fludeoxyglucose F18	Fludeoxyglucose F18	Feinstein	Shertech Labs
12/18/2014	Ammonia N 13	Ammonia N 13	Feinstein	WI Medical Cyclotron
12/18/2014	Epivir	Lamivudine	ViiV Healthcare	Lupin
12/19/2014	Vivelle-Dot	Estradiol	Novartis	Mylan Technologies
12/19/2014	Acetazolamide Sodium	Acetazolamide Sodium	X Gen Pharms	Emcure Pharms
12/23/2014	Prometh VC w/Codeine	Promethazine Hydrochloride / Phenylephrine Hydrochloride w/Codeine Phosphate	Actavis Mid Atlantic	Hi-Tech Pharma
12/23/2014	Pometh VC Plain	Phenylephrine Hydrochloride / Promethazine Hydrochloride	Actavis Mid Atlantic	Hi-Tech Pharmacal
12/29/2014	Kadian	Morphine Sulfate	Watson Labs	Teva Pharms USA