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ANDA Approvals

Approval Date

Reference Listed Drug

Generic Drug Name

NDA Holder

ANDA Applicant

10/1/2012 Prozac Fluoxetine Hydrochloride Eli Lilly and Co Heritage Pharms
10/1/2012 Duoneb Albuterol Sulfate and Ipratropium Bromide Dey Ritedose Corp
10/3/2012 Trileptal Oxcarbazepine Novartis Roxane
10/3/2012 Avapro Irbesartan Sanofi Aventis US Macleods Pharms
10/5/2012 Intuniv Guanfacine Hydrochloride Shire Actavis Elizabeth
10/10/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Zydus Pharms USA
10/11/2012 Idamycin PFS Idarubicin Hydrochloride Pharmacia and Upjohn Onco Therapies
10/11/2012 Avita Tretinoin Mylan Precision Dermat
10/12/2012 Avapro Irbesartan Sanofi Aventis US Watson Labs
10/12/2012 Sanctura XR Trospium Chloride Allergan Watson Labs
10/15/2012 Avapro Irbesartan Sanofi Aventis US Roxane
10/15/2012 Avalide Irbesartan and Hydrochlorothiazide Sanofi Aventis Roxane
10/15/2012 Avalide Irbesartan; Hydrochlorothiazide Sanofi Aventis Roxane
10/15/2012 Avapro Irbesartan Sanofi Aventis US Alembic Pharms
10/15/2012 Avalide Irbesartan and Hydrochlorothiazide Sanofi Aventis Alembic
10/15/2012 Requip XL Ropinirole Hydrochloride SmithKline Beecham Mylan
10/15/2012 Avapro Irbesartan Sanofi Aventis US Apotex
10/15/2012 Avalide Irbesartan and Hydrochlorothiazide Sanofi Aventis Apotex
10/15/2012 Avapro Irbesartan Sanofi Aventis US Lupin
10/16/2012 Carbatrol Carbamazepine Shire Teva
10/16/2012 Fludarabine Phosphate Fludarabine Phosphate Hospira Onco Therapies
10/16/2012 Neurontin Gabapentin Pfizer Pharms Invagen Pharms
10/17/2012 Nordette-28 Kurvelo Teva Branded Pharm Lupin
10/18/2012 Atracurium Besylate and Atracurium Besylate Preservative Free Atracurium Besylate Bedford Hospira
10/18/2012 Atracurium Besylate and Atracurium Besylate Preservative Free Atracurium Besylate Preservative Free Bedford Hospira
10/18/2012 Provigil Modafinil Cephalon Alembic
10/22/2012 Avalide Irbesartan and Hydrochlorothiazide Sanofi Aventis Watson Labs
10/22/2012 Grifulvin V Griseofulvin Valeant Luxembourg Sigmapharm Labs
10/22/2012 GRIS-PEG Griseofulvin, Ultramicrosize Pedinol Sigmapharm Labs
10/23/2012 Seasonale Levonorgestrel and Ethinyl Estradiol Teva Branded Pharm Lupin
10/23/2012 Fenofibrate (Micronized) Fenofibrate (Micronized) Teva Mylan
10/24/2012 Tofranil Imipramine Hydrochloride Mallinckrodt Excellium
10/24/2012 Aricept Donepezil Hydrochloride Eisai Zydus Pharms USA
10/24/2012 Tretinoin Tretinoin Barr Labs Anchen Pharms
10/26/2012 Actos Pioglitazone Hydrochloride Takeda Pharms USA Watson Labs
10/26/2012 Mirapex Pramipexole Dihydrochloride Boehringer Ingelheim Aurobindo Pharma
11/1/2012 Provigil Modafinil Cephalon Carlsbad
11/1/2012 Keppra XR Levetiracetam UCB Sandoz
11/2/2012 Symbyax Olanzapine and Fluoxetine Hydrochloride Eli Lilly and Co Par Pharm
11/6/2012 Ovcon-35 Norethindrone and Ethinyl Estradiol Warner Chilcott Vintage Pharms
11/6/2012 Revatio Sildenafil Citrate Pfizer Apotex Corp
11/6/2012 Revatio Sildenafil Citrate Pfizer Torrent Pharms
11/6/2012 Revatio Sildenafil Citrate Pfizer Watson Labs
11/6/2012 Revatio Sildenafil Citrate Pfizer Dr Reddy's Labs
11/7/2012 Acetadote Acetylcysteine Cumberland Pharms Innopharma
11/8/2012 Doxorubicin Hydrochloride Doxorubicin Hydrochloride Bedford Alvogen
11/8/2012 Protonix IV Pantoprazole Sodium Wyeth Pharms Akorn
11/9/2012 Zanaflex Tizanidine Hydrochloride Acorda Mylan
11/9/2012 Revatio Sildenafil Citrate Pfizer Mylan
11/14/2012 Avapro Irbesartan Sanofi Aventis US Cipla
11/16/2012 Symbyax Olanzapine and Fluoxetine Hydrochloride Lilly Sandoz
11/16/2012 Ultram Tramadol Hydrochloride Janssen Pharms IPCA Labs
11/19/2012 Prilosec Omeprazole AstraZeneca Zydus Pharms USA
11/19/2012 Roxicodone Oxycodone Hydrochloride Mallinckrodt Aurolife Pharma
11/19/2012 Vivactil Protriptyline Hydrochloride Odyssey Pharms Epic Pharma
11/19/2012 Solodyn Minocycline Hydrochloride Medicis Aurobindo Pharma
11/20/2012 Stalevo 200 Carbidopa, Levodopa and Entacapone Orion Pharma Wockhardt
11/20/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Wockhardt
11/21/2012 Wellbutrin XL Bupropion Hydrochloride Valeant Intl Wockhardt
11/26/2012 Luxiq Betamethasone Valerate Stiefel Cobrek Pharms
11/26/2012 Ifosfamide Ifosfamide Teva Parenteral Onco Therapies
11/27/2012 Detrol Tolterodine Tartrate Pharmacia and Upjohn Mylan
11/28/2012 Requip Ropinirole Hydrochloride GlaxoSmithKline Orchid Healthcare
11/28/2012 Benztropine Mesylate Benztropine Mesylate USL Pharma Excellium
11/28/2012 Cefadroxil Cefadroxil Lupin Hikma Pharms
11/28/2012 Zanaflex Tizanidine Hydrochloride Acorda Unichem Labs
11/29/2012 Cytomel Liothyronine Sodium King Pharms Sigmapharm Labs
11/30/2012 Dexedrine Dextroamphetamine Sulfate Corepharma Actavis Elizabeth
12/4/2012 Atacand HCT Candesartan Cilexetil and Hydrochlorothiazide AstraZeneca Mylan
12/4/2012 Atacand HCT Candesartan Cilexetil and Hydrochlorothiazide AstraZeneca Apotex
12/7/2012 Apresoline Hydralazine Hydrochloride Novartis Alkem Labs
12/7/2012 Cardizem CD Diltiazem Hydrochloride Valeant Intl Actavis
12/7/2012 Tricor Fenofibrate Abbvie Mylan
12/11/2012 Novantrone Mitoxantrone Hydrochloride EMD Serono Onco Therapies
12/12/2012 Risperdal Risperidone Janssen Pharms Tris Pharma
12/14/2012 Seroquel Quetiapine Fumarate AstraZeneca Sandoz
12/14/2012 Aricept ODT Donepezil Hydrochloride Eisai Inc Macleods Pharms
12/14/2012 Ultracet Tramadol Hydrochloride and Acetaminophen Janssen Pharms Micro Labs India
12/14/2012 Qualaquin Quinine Sulfate Mutual Pharm Co Inc Mylan
12/14/2012 Ammonia N 13 Ammonia N 13 Feinstein Houston Cyclotron
12/17/2012 Ziagen Abacavir Sulfate VIIV Healthcare Aurobindo Pharma
12/17/2012 Ziagen Abacavir Sulfate VIIV Healthcare Apotex
12/17/2012 Pepcid Famotidine Salix Pharms Novel Labs
12/18/2012 Yasmin Drospirenone and Ethinyl Estradiol Bayer Healthcare Lupin
12/18/2012 Prevacid Lansoprazole Takeda Pharms USA Natco Pharma
12/18/2012 Singulair Montelukast Sodium Merck Mylan
12/27/2012 Lysteda Tranexamic Acid  Ferring Pharms Watson Labs
12/31/2012 Maxalt Rizatriptan Benzoate Merck  Mylan
12/31/2012 Maxalt Rizatriptan Benzoate Merck  Sandoz
12/31/2012 Antabuse Disulfiram Odyssey Pharms Vintage Pharms
12/31/2012 Maxalt Rizatriptan Benzoate Merck  Natco Pharma
12/31/2012 Maxalt Rizatriptan Benzoate Merck  Glenmark Generics
12/31/2012 Maxalt Rizatriptan Benzoate Merck  Mylan
12/31/2012 Maxalt Rizatriptan Benzoate Merck  Sun Pharma Global
12/31/2012 Maxalt Rizatriptan Benzoate Merck  Apotex Corp
12/31/2012 Maxalt Rizatriptan Benzoate Merck  Aurobindo Pharma



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