|
Approval Date
|
Reference Listed Drug
|
Generic Drug Name
|
NDA Holder
|
ANDA Applicant
|
|
7/1/2013
|
Riluzole
|
Riluzole
|
Covis Pharma
|
Mylan Pharms
|
|
7/1/2013
|
Maxalt-MLT
|
Rizatriptan Benzoate
|
Merck
|
Apotex
|
|
7/1/2013
|
Maxalt-MLT
|
Rizatriptan Benzoate
|
Merck
|
Aurobindo Pharma
|
|
7/1/2013
|
Maxalt-MLT
|
Rizatriptan Benzoate
|
Merck
|
Glenmark Generics
|
|
7/1/2013
|
Propecia
|
Finasteride
|
Merck
|
Hetero Labs Ltd III
|
|
7/1/2013
|
Maxalt
|
Rizatriptan Benzoate
|
Merck
|
Invagen Pharms
|
|
7/1/2013
|
Maxalt-MLT
|
Rizatriptan Benzoate
|
Merck
|
Natco Pharma
|
|
7/1/2013
|
Maxalt-MLT
|
Rizatriptan Benzoate
|
Merck
|
Sandoz
|
|
7/1/2013
|
Propecia
|
Finasteride
|
Merck
|
Sun Pharma Global
|
|
7/1/2013
|
Azilect
|
Rasagiline Mesylate
|
Teva
|
Watson Labs
|
|
7/3/2013
|
Neurontin
|
Gabapentin
|
Parke Davis
|
Taro
|
|
7/5/2013
|
Aricept
|
Donepezil Hydrochloride
|
Eisai
|
Alvogen Pine Brook
|
|
7/9/2013
|
Concerta
|
Methylphenidate Hydrochloride
|
Janssen Pharms
|
Kudco Ireland
|
|
7/11/2013
|
Dacogen
|
Decitabine
|
Eisai
|
Dr. Reddy's Labs
|
|
7/11/2013
|
Opana ER
|
Oxymorphone Hydrochloride
|
Endo Pharms
|
Actavis Elizabeth
|
|
7/11/2013
|
Prandin
|
Repaglinide
|
Novo Nordisk
|
Caraco
|
|
7/11/2013
|
Percocet
|
Oxycodone / Acetaminophen
|
Vintage Pharms
|
Vintage Pharms
|
|
7/11/2013
|
Percocet
|
Oxycodone / Acetaminophen
|
Vintage Pharms
|
Vintage Pharms
|
|
7/12/2013
|
Folic Acid
|
Folic Acid
|
Amneal Pharm
|
Bicon Pharm
|
|
7/12/2013
|
Ortho-Cept
|
Desogestrel / Ethinyl Estradiol
|
Janssen Pharms
|
Novast Labs
|
|
7/12/2013
|
Oxycodone Hydrochloride
|
Oxycodone Hydrochloride
|
Lehigh Valley
|
Roxane
|
|
7/12/2013
|
Neurontin
|
Gabapentin
|
Pfizer
|
Allied Pharma
|
|
7/12/2013
|
Cellcept
|
Mycophenolate Mofetil
|
Roche Palo
|
Alkem Labs
|
|
7/15/2013
|
Opana ER
|
Oxymorphone Hydrochloride
|
Endo Pharms
|
Roxane
|
|
7/15/2013
|
Lamictal ODT
|
Lamotrigine
|
GlaxoSmithKline
|
Watson Labs
|
|
7/15/2013
|
Percocet
|
Oxycodone / Acetaminophen
|
Vintage Pharms
|
Aurolife Pharma
|
|
7/15/2013
|
Oxycodone Hydrochloride
|
Oxycodone Hydrochloride
|
Vistapharm
|
Roxane
|
|
7/16/2013
|
Campral
|
Acamprosate Calcium
|
Forest Labs
|
Glenmark Generics
|
|
7/17/2013
|
Retin-A Micro
|
Tretinoin
|
Valeant Intl
|
Spear Pharms
|
|
7/17/2013
|
Retin-A Micro
|
Tretinoin
|
Valeant Intl
|
Spear Pharms
|
|
7/18/2013
|
Trilipix
|
Fenofibric Acid
|
Abbvie
|
Anchen Pharms
|
|
7/19/2013
|
Firtanet
|
Metformin Hydrochloride
|
Andrx Labs
|
Lupin
|
|
7/19/2013
|
Zofran / Zofran Preservative Free
|
Ondansetron Hydrochloride Preservative Free
|
GlaxoSmithKline
|
BD RX
|
|
7/24/2013
|
Aricept
|
Donepezil Hydrochloride
|
Eisai
|
Dr. Reddy's Labs
|
|
7/24/2013
|
Aricept
|
Donepezil Hydrochloride
|
Eisai
|
Par Pharm
|
|
7/26/2013
|
Antara (Micronized)
|
Fenofibrate (Micronized)
|
Lupiin Atlantis
|
Apotex
|
|
7/26/2013
|
Silenor
|
Doxepin Hydrochloride
|
Perix Theraps
|
Actavis Elizabeth
|
|
7/26/2013
|
Rozerem
|
Ramelteon
|
Takeda Pharms USA
|
Teva Pharms USA
|
|
7/26/2013
|
Xyzal
|
Levocetirizine Dihydrochloride
|
UCB
|
Taro Pharm Inds
|
|
7/30/2013
|
Zestril
|
Lisinopril
|
Astrazeneca
|
Accord Healthcare
|
|
7/30/2013
|
Cutivate
|
Fluticasone Propionate
|
Fougera Pharms
|
Perrigo Israel
|
|
7/31/2013
|
Dextroamphetamine Sulfate
|
Dextroamphetamine Sulfate
|
Barr
|
Aurolife Pharma
|
|
8/1/2013
|
Amaryl
|
Glimepiride
|
Sanofi Aventis US
|
Hikma Pharms
|
|
8/1/2013
|
Mircette
|
Pimtrea
|
Teva Branded Pharm
|
Novast Labs
|
|
8/1/2013
|
NOR-QD
|
Norethindrone
|
Watson Labs (Utah)
|
Haupt Pharma
|
|
8/2/2013
|
Neurontin
|
Gabapentin
|
Pfizer
|
Taro
|
|
8/5/2013
|
Ovcon-50
|
Norethindrone / Ethinyl Estradiol
|
Warner Chilcott
|
Famy Care
|
|
8/7/2013
|
Gris-Peg
|
Griseofulvin
|
Pedinol
|
Sandoz
|
|
8/8/2013
|
Levaquin in Dextrose 5% in Plastic Container
|
Levofloxacin in Dextrose 5% in Plastic Container
|
Janssen Pharms
|
Claris Lifesciences
|
|
8/8/2013
|
Antabuse
|
Disulfiram
|
Odyssey Pharms
|
Alvogen Pine Brook
|
|
8/9/2013
|
Derma-Smoothe/FS
|
Fluocinolone Acetonide
|
Hill Dermac
|
Perrigo Israel
|
|
8/9/2013
|
Derma-Smoothe/FS
|
Fluocinolone Acetonide
|
Hill Dermac
|
Perrigo Israel
|
|
8/14/2013
|
Furadantin
|
Nitrofurantoin
|
Shionogi
|
Caraco
|
|
8/16/2013
|
Prometrium
|
Progesterone
|
AbbVie
|
Banner Pharmacaps
|
|
8/16/2013
|
Reclast
|
Zoledronic Acid
|
Novartis
|
Pharmaceutics
|
|
8/19/2013
|
Prevacid
|
Lansoprazole
|
Takeda Pharms USA
|
Zydus Healthcare
|
|
8/21/2013
|
Hydroxyzine Hydrochloride
|
Hydroxyzine Hydrochloride
|
Hi Tech Pharma; Vintage Pharms; and Wockhardt
|
Silarx Pharms
|
|
8/21/2013
|
Rifadin
|
Rifampin
|
Sanofi Aventis US
|
Lupin Pharms
|
|
8/23/2013
|
Prandin
|
Repaglinide
|
Novo Nordisk
|
Mylan Pharms
|
|
8/23/2013
|
Cosmegen
|
Dactinomycin
|
Recordati Rare
|
Pharmaforce
|
|
8/23/2013
|
Loestrin Fe 1.5/30
|
Larin Fe 1.5/30
|
Warner Chilcott
|
Novast Labs
|
|
8/26/2013
|
Loestrin FE 1/20
|
Larin FE 1/20
|
Warner Chilcott
|
Novast Labs
|
|
8/28/2013
|
Zymaxid
|
Gatifloxacin
|
Allergan
|
Lupin
|
|
8/28/2013
|
Focalin XR
|
Dexmethylphenidate Hydrochloride
|
Novartis
|
Mylan Pharms
|
|
8/29/2013
|
Adenocard
|
Adenosine
|
Astellas
|
Teva Pharms USA
|
|
8/29/2013
|
Hepsera
|
Adefovir Dipivoxil
|
Gilead
|
Sigmapharm Labs
|
|
8/29/2013
|
Hycamtin
|
Topotecan Hydrochloride
|
GlaxoSmithKline
|
Sun Pharm Inds
|
|
8/30/2013
|
Hectorol
|
Doxercalciferol
|
Genzyme
|
Innopharma
|
|
8/30/2013
|
Cozaar
|
Losartan Potassium
|
Merck
|
IPCA Labs
|
|
8/30/2013
|
Prevpac
|
Lansoprazole / Amoxicillin / Clarithromycin
|
Takeda Pharms USA
|
Teva Pharms USA
|
|
8/30/2013
|
Mircette
|
Desogestrel / Ethinyl Estradiol
|
Teva Branded Pharm
|
Famy Care
|
|
9/9/2013
|
Keppra XR
|
Levetiracetam
|
UCB
|
Sun Pharma Global
|
|
9/10/2013
|
Ambien CR
|
Zolpidem Tartrate
|
Sanofi Aventis US
|
Apotex
|
|
9/11/2013
|
Glucophage
|
Metformin Hydrochloride
|
Bristol-Myers Squibb
|
Sciegen Pharms
|
|
9/11/2013
|
Topamax
|
Topiramate
|
Janssen Pharms
|
Lupin
|
|
9/11/2013
|
Ambien CR
|
Zolpidem Tartrate
|
Sanofi Aventis US
|
Lupin
|
|
9/12/2013
|
Navelbine
|
Vinorelbine Tartrate
|
Pierre Fabre
|
Dr Reddy's Labs
|
|
9/12/2013
|
Azilect
|
Rasagiline Mesylate
|
Teva Branded Pharm
|
Apotex
|
|
9/13/2013
|
Micronor
|
Norethindrone
|
Janssen Pharms
|
Novast Labs
|
|
9/13/2013
|
Prevacid
|
Lansoprazole
|
Takeda Pharms USA
|
Sun Pharma Global
|
|
9/13/2013
|
Prevacid
|
Lansoprazole
|
Takeda Pharms USA
|
Sun Pharma Global
|
|
9/13/2013
|
Ziagen
|
Abacavir Sulfate
|
VIIV Healthcare
|
Hetero Labs Ltd III
|
|
9/13/2013
|
NOR-QD
|
Norethindrone
|
Watson Labs (Utah)
|
Novast Labs
|
|
9/16/2013
|
Vidaza
|
Azacitidine
|
Celgene
|
Dr Reddy's Labs
|
|
9/16/2013
|
Xeloda
|
Capecitabine
|
Hoffmann La Roche
|
Teva Pharms USA
|
|
9/17/2013
|
Xyzal
|
Levocetirizine Dihydrochloride
|
UCB
|
Micro Labs India
|
|
9/18/2013
|
Cytovene
|
Ganciclovir
|
Roche Palo
|
Pharmaforce
|
|
9/20/2013
|
Glucotrol XL
|
Glipizide
|
Pfizer
|
Par Pharm
|
|
9/20/2013
|
Nitrolingual Pumpspray
|
Nitroglycerin
|
Pohl Boskamp
|
Perrigo Israel
|
|
9/20/2013
|
Topicort
|
Desoximetasone
|
Taro
|
Glenmark Generics
|
|
9/24/2013
|
Bacteriostatic Saline
|
Sodium Chloride 0.9% in Plastic Container
|
Hospira / Fresenius Kabi USA / Taro Pharms Ireland
|
Hikma Maple
|
|
9/26/2013
|
Ovcon-35
|
Vyfemla
|
Warner Chilcott
|
Lupin
|
|
9/27/2013
|
Zemplar
|
Paricalcitol
|
Abbvie
|
Teva Pharms USA
|
|
9/27/2013
|
Vimovo
|
Naproxen / Esomeprazole Magnesium
|
Astrazeneca
|
Dr Reddy's Labs
|
|
9/27/2013
|
Pulmicort Respules
|
Budesonide
|
Astrazeneca
|
Sandoz
|
|
9/27/2013
|
Locoid / Locoid Lipocream
|
Hydrocortisone Butyrate
|
Precision Dermat
|
Glenmark Generics
|
|
9/30/2013
|
Kapvay
|
Clonidine Hydrochloride
|
Concordia Pharms
|
Anchen Pharms
|
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