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ANDA Approvals
Fall 2012
|
Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
|
7/2/2012 |
Clobex |
Clobetasol Propionate |
Galderma Labs |
Taro |
|
7/3/2012 |
Lyrica |
Pregabalin |
PF Prism |
Lupin |
|
7/3/2012 |
Lyrica |
Pregabalin |
PF Prism |
Teva |
|
7/3/2012 |
Lyrica |
Pregabalin |
PF Prism |
Watson Labs |
|
7/9/2012 |
Arthrotec |
Diclopfenac Sodium and Misoprostol |
GD Searle |
Watson Labs |
|
7/10/2012 |
Trandate |
Labetalol Hydrochloride |
Prometheus Labs |
Par |
|
7/12/2012 |
Plan B One-Step |
Levonorgestrel |
Duramed |
Watson Labs |
|
7/13/2012 |
Ritalin LA |
Methylphenidate Hydrochloride |
Novartis |
Barr Labs |
|
7/16/2012 |
Provigil |
Modafinil |
Cephalon |
Mylan |
|
7/16/2012 |
Dibenzyline |
Phenoxybenzamine Hydrochloride |
Wellspring Pharm |
Roxane |
|
7/16/2012 |
Comtan |
Entacapone |
Orion Pharma |
Sun Pharma Global |
|
7/17/2012 |
Lipitor |
Atorvastatin Calcium |
Pfizer |
Dr. Reddys Labs |
|
7/17/2012 |
Multiple TE's |
Fluorouracil |
Quad Pharms |
Onco Therapies |
|
7/17/2012 |
Multiple TE's |
Fluorouracil |
Quad Pharms |
Onco Therapies |
|
7/18/2012 |
Doxorubicin Hydrochloride |
Doxorubicin Hydrochloride |
Bedford |
Sandoz |
|
7/19/2012 |
Metadate CD |
Methylphenidate Hydrochloride |
UCB |
Teva |
|
7/20/2012 |
Glucophage XR |
Metformin Hydrochloride |
Bristol Myers Squibb |
Aurobindo Pharma |
|
7/20/2012 |
Sporanox |
Itraconazole |
Janssen Pharms |
Mylan |
|
7/20/2012 |
Keppra |
Levetiracetam |
UCB |
Vintage Pharms |
|
7/24/2012 |
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone |
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone |
Bausch and Lomb |
Akorn |
|
7/25/2012 |
Allegra |
Fexofenadine Hydrochloride |
Sanofi Aventis US |
Actavis Mid Atlantic |
|
7/25/2012 |
Biaxin |
Clarithromycin |
Abbvie |
Aurobindo |
|
7/25/2012 |
Cytotec |
Misoprostol |
GD Searle LLC |
Novel Labs |
|
7/26/2012 |
Percocet |
Oxycodone and Acetaminophen |
Endo Pharms |
Alvogen |
|
7/26/2012 |
Oxycodone Hydrochloride |
Oxycodone Hydrochloride |
Lehigh Valley |
Coastal Pharms |
|
7/26/2012 |
Vistide |
Cidofovir |
Gilead Sciences Inc |
Emcure Pharms |
|
7/27/2012 |
Orphenadrine Citrate |
Orphenadrine Citrate |
Sandoz |
Invagen Pharms |
|
7/30/2012 |
Aygestin |
Norethindrone Acetate |
Duramed Res |
Amneal Pharms |
|
7/30/2012 |
Ambien |
Zolpidem Tartrate |
Sanofi Aventis US |
Cipla |
|
7/30/2012 |
Maxipime |
Cefepime Hydrochloride |
Hospira Inc |
Hospira Inc |
|
7/30/2012 |
Oxycodone Hydrochloride |
Oxycodone Hydrochloride |
Lehigh Valley |
VistaPharm |
|
7/30/2012 |
Pulmicort Respules |
Budesonide |
Astrazeneca |
Watson Labs |
|
8/1/2012 |
Toprol-XL |
Metoprolol Succinate |
Astrazeneca |
Dr. Reddys Labs |
|
8/1/2012 |
Fortamet |
Metformin Hydrochloride |
Andrx Labs LLC |
Mylan |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Apotex |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Apotex |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Aurobindo Pharma |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Aurobindo Pharma |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Endo Pharms |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Endo Pharms |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Glenmark Generics |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Kudco Ireland |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Kudco Ireland |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Mylan Pharms |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Mylan Pharms |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Roxane |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Roxane |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Sandoz |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Sandoz |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Teva |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Teva |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Teva |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Torrent Pharms |
|
8/3/2012 |
Singulair |
Montelukast Sodium |
Merck |
Torrent Pharms |
|
8/6/2012 |
Singulair |
Montelukast Sodium |
Merck |
Dr. Reddys Labs |
|
8/6/2012 |
Singulair |
Montelukast Sodium |
Merck |
Dr. Reddys Labs |
|
8/6/2012 |
Morphine Sulfate |
Morphine Sulfate |
Roxane |
Paddock |
|
8/7/2012 |
Multiple TE's |
Oxaliplatin |
|
Onco Therapies |
|
8/8/2012 |
Oxaliplatin |
Oxaliplatin |
Sun Pharma Global |
Actavis Totowa |
|
8/8/2012 |
Hycamtin |
Topotecan Hydrochloride |
GlaxoSmithKline |
Innopharma |
|
8/8/2012 |
Lithium Carbonate |
Lithium Carbonate |
Roxane |
Mylan |
|
8/8/2012 |
Oxaliplatin |
Oxaliplatin |
Sun Pharma Global |
Onco Therapies |
|
8/9/2012 |
Diltiazem Hydrochloride |
Diltiazem Hydrochloride |
Beford |
Hikma Farmaceutica |
|
8/9/2012 |
NTE |
Amphetamine Sulfate |
|
Independence Pharms |
|
8/9/2012 |
Hyzaar |
Losartan Potassium and Hydrochlorothiazide |
Merck |
MacLeods Pharms |
|
8/9/2012 |
Clobex |
Clobetasol Propionate |
Galderma Labs |
Perrigo Israel |
|
8/10/2012 |
Vancomycin HCL |
Vancomycin Hydrochloride |
Quad Pharms |
Sagent Pharms |
|
8/10/2012 |
Vancomycin HCL |
Vancomycin Hydrochloride |
Quad Pharms |
Sandoz |
|
8/10/2012 |
Uroxatral |
Alfuzosin Hydrochloride |
Sanofi Aventis US |
Wockhardt |
|
8/14/2012 |
Videx |
Didanosine |
Bristol Myers Squibb |
Aurobindo |
|
8/14/2012 |
Olux E |
Clobetasol Propionate |
Stiefel Labs Inc |
Perrigo Israel |
|
8/14/2012 |
Plavix |
Clopidogrel Bisulfate |
Sanofi Aventis US |
Wockhardt |
|
8/15/2012 |
Boniva |
Ibandronate Sodium |
Hoffmann LA Roche |
Mutual Pharm Co |
|
8/15/2012 |
Toprol-XL |
Metoprolol Succinate |
Astrazeneca |
Dr. Reddys Labs |
|
8/15/2012 |
Felodipine |
Felodipine |
Mylan |
Wockhardt |
|
8/16/2012 |
Comtan |
Entacapone |
Orion Pharma |
Wockhardt |
|
8/17/2012 |
Aricept |
Donepezil Hydrochloride |
Eisai Inc |
MacLeods Pharms |
|
8/17/2012 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Mylan |
|
8/20/2012 |
Rocephin |
Ceftriaxone |
Hoffmann LA Roche |
Hospira |
|
8/21/2012 |
Doxy 100 |
Doxycycline |
App Pharms |
Pfizer |
|
8/21/2012 |
Myfortic |
Mycophenolic Acid |
Novartis |
Apotex |
|
8/22/2012 |
Alocril |
Nedocromil Sodium |
Allergan |
Akorn |
|
8/23/2012 |
Lidoderm |
Lidocaine |
Teikoku Pharma USA |
Watson Labs |
|
8/24/2012 |
Nafcillin Sodium |
Nafcillin Sodium |
Sandoz |
Astral Pharm Inds |
|
8/24/2012 |
Nafcillin Sodium |
Nafcillin Sodium |
Sandoz |
Astral Pharm Inds |
|
8/27/2012 |
Keppra XR |
Levetiracetam |
UCB |
Rouses Point Pharms |
|
8/27/2012 |
Zemuron |
Rocuronium Bromide |
Schering |
Tamarang |
|
8/28/2012 |
Cleocin |
Clindamycin Palmitate Hydrochloride |
Pharmacia and Upjohn |
Lyne |
|
8/28/2012 |
Hycamtin |
Topotecan Hydrochloride |
GlaxoSmithKline |
Onco Therapies |
|
8/28/2012 |
Romazicon |
Flumazenil |
Hoffmann LA Roche |
Sagent Pharms |
|
8/29/2012 |
Uroxatral |
Alfuzosin Hydrochloride |
Sanofi Aventis US |
Aurobindo Pharma |
|
8/29/2012 |
Cafcit |
Caffeine Citrate |
Bedford Labs |
Sagent Pharms |
|
8/29/2012 |
Cafcit |
Caffeine Citrate |
Bedford Labs |
Sagent Pharms |
|
8/29/2012 |
Nuvigil |
Armodafinil |
Cephalon |
Watson Labs |
|
8/30/2012 |
Wellbutrin SR |
Bupropion Hydrochloride |
GlaxoSmithKline |
Wockhardt |
|
8/31/2012 |
Astepro |
Azelastine Hydrochloride |
Meda Pharms |
Apotex |
|
8/31/2012 |
NTE's |
Vinorelbine |
|
Onco Therapies |
|
9/5/2012 |
Lotrel |
Amlodipine Besylate and Benazepril Hydrochloride |
Novartis |
Aurobindo Pharma |
|
9/5/2012 |
Geodon |
Ziprasidone Hydrochloride |
Pfizer |
Wockhardt |
|
9/6/2012 |
Leucovorin Calcium & Leucovorin Calcium Preservative Free |
Leucovorin Calcium Preservative Free |
Bedford |
Sagent Pharms |
|
9/6/2012 |
Leucovorin Calcium Preservative Free |
Leucovorin Calcium Preservative Free |
Bedford |
Sagent Pharms |
|
9/6/2012 |
Ultracet |
Tramadol Hydrochloride and Acetaminophen |
Janssen Pharms |
Zydus Pharms USA |
|
9/7/2012 |
Levaquin |
Levofloxacin |
Janssen Pharms |
Zydus Pharms USA |
|
9/10/2012 |
Gemzar |
Gemcitabine Hydrochloride |
Lilly |
Hameln RDS GMBH |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Accord Hlthcare |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Apotex |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Aurobindo Pharma |
|
9/11/2012 |
Gemzar |
Gemcitabine Hydrochloride |
Lilly |
Emcure Pharms |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Hikma Pharms |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Invagen Pharms |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Lupin |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
MacLeods Pharms |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Torrent Pharms |
|
9/11/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Zydus Pharms USA |
|
9/12/2012 |
Zyprexa Zydis |
Olanzapine |
Lilly |
Jubilant Organosys |
|
9/12/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Jubilant Organosys |
|
9/12/2012 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
STI Pharma |
|
9/13/2012 |
Fioricet |
Butalbital, Acetaminophen and Caffeine |
Watson Pharms |
Lannett Holdings |
|
9/14/2012 |
Prevacid |
Lansoprazole |
Takeda Pharms USA |
Wockhardt USA |
|
9/17/2012 |
Trileptal |
Oxcarbazepine |
Novartis |
Amneal Pharms |
|
9/17/2012 |
Singulair |
Montelukast Sodium |
Merck |
Dr. Reddys Labs |
|
9/17/2012 |
Antivert |
Meclizine Hydrochloride |
Pfizer |
Mylan |
|
9/18/2012 |
Cozaar |
Losartan Potassium |
Merck |
Cadista Pharms |
|
9/18/2012 |
Hyzaar |
Losartan Potassium and Hydrochlorothiazide |
Merck |
Cadista Pharms |
|
9/18/2012 |
Delatestryl |
Testosterone Enanthate |
Endo Pharm |
Hikma Farmaceutica |
|
9/20/2012 |
Robinul |
Glycopyrrolate |
Shionogi |
Excellium |
|
9/20/2012 |
Mirapex |
Pramipexole Dihydrochloride |
Boehringer Ingelheim |
MacLeods Pharms |
|
9/20/2012 |
Carbatrol |
Carbamazepine |
Shire |
Teva |
|
9/21/2012 |
Singulair |
Montelukast Sodium |
Merck |
Accord Hlthcare |
|
9/21/2012 |
Adipex-P |
Phentermine Hydrochloride |
Teva |
Mirror Pharms |
|
9/21/2012 |
Diovan HCT |
Valsartan and Hydrochlorothiazide |
Novartis |
Mylan Pharms |
|
9/24/2012 |
Hydrochlorothiazide |
Hydrochlorothiazide |
Ivax Sub Teva Pharms |
Accord Hlthcare |
|
9/24/2012 |
Detrol |
Tolterodine Tartrate |
Pharmacia and Upjohn |
Apotex |
|
9/24/2012 |
Pamine |
Methscopolamine Bromide |
Fougera Pharms |
Bayshore Pharms |
|
9/24/2012 |
Pietal |
Cilostazol |
Otsuka |
Biokey |
|
9/24/2012 |
Pietal |
Cilostazol |
Otsuka |
Biokey |
|
9/24/2012 |
Cozaar |
Losartan Potassium |
Merck |
Micro Labs Ltd India |
|
9/24/2012 |
Emend |
Aprepitant |
Merck |
Sandoz |
|
9/25/2012 |
NTE's |
Amlodipine, Valsartan and Hydrochlorothiazide |
|
Teva |
|
9/25/2012 |
Zarontin |
Ethosuximide |
Parke Davis |
Zydus Pharms USA |
|
9/26/2012 |
Provigil |
Modafinil |
Cephalon |
Hikma Pharms |
|
9/26/2012 |
Navelbine |
Vinorelbine Tartrate |
Pierre Fabre |
Jiangsu Hansoh Pharm |
|
9/26/2012 |
Provigil |
Modafinil |
Cephalon |
Orchid Hlthcare |
|
9/26/2012 |
Navelbine |
Vinorelbine Tartrate |
Pierre Fabre |
Jiangsu Hansoh Pharm |
|
9/27/2012 |
Provigil |
Modafinil |
Cephalon |
Aurobindo Pharma |
|
9/27/2012 |
Avalide |
Hydrochlorothiazide; Irbesartan |
Sanofi Aventis US |
Sandoz |
|
9/27/2012 |
Avapro |
Irbesartan |
Sanofi Aventis US |
Sandoz |
|
9/27/2012 |
Avalide |
Hydrochlorothiazide; Irbesartan |
Sanofi Aventis US |
Mylan |
|
9/27/2012 |
Avapro |
Irbesartan |
Sanofi Aventis US |
Zydus pharms USA |
|
9/27/2012 |
Avapro |
Irbesartan |
Sanofi Aventis US |
Mylan |
|
9/27/2012 |
Avalide |
Hydrochlorothiazide; Irbesartan |
Sanofi Aventis US |
Macleods Pharms |
|
9/27/2012 |
Provigil |
Modafinil |
Cephalon |
Aurobindo Pharma |
|
9/27/2012 |
Avapro |
Irbesartan |
Sanofi Aventis US |
Prinston |
|
9/27/2012 |
Avapro |
Irbesartan |
Sanofi Aventis US |
Aurobindo Pharma |
|
9/27/2012 |
Avapro |
Irbesartan |
Sanofi Aventis US |
Dr. Reddys Labs |
|
9/27/2012 |
Avalide |
Hydrochlorothiazide; Irbesartan |
Sanofi Aventis US |
Dr. Reddys Labs |
|
9/27/2012 |
Topicort |
Desoximetasone |
Taro |
Fougera Pharms |
|
9/27/2012 |
Prograf |
Tacrolimus |
Astellas |
Panacea Biotec |
|
9/27/2012 |
Diltzac |
Diltiazem Hydrochloride |
Apotex |
Actavis Elizabeth |
|
09/28/2012 |
Qualaquin |
Quinine Sulfate |
AR Holding Co |
Teva Pharms |
|
09/28/2012 |
Prometrium |
Pogesterone |
Abbott Labs |
Sofgen Pharms |
|
09/28/2012 |
Indomethacin |
Indomethacin |
Sandoz |
Hetero Labs |
|
09/28/2012 |
Protonix |
Pantoprazole Sodium |
Wyeth Pharmss Inc |
Aurobindo Pharma |
|
09/28/2012 |
Phentermine Hydrochloride |
Phentermine Hydrochloride |
Sandoz |
Elite Labs |
|
09/28/2012 |
Coly-Mycin M |
Colistimethate sodium |
JHP Pharms |
Emcure Pharms |
Related Publications
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