|
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 |
|
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 |
