ANDA Approvals

Summer 2012

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
4/2/2012 Lexapro Escitalopram Oxalate Forest Labs Aurobindo Pharma
4/2/2012 Viorele Ethinyl Estradiol and Desogestrel Merck Glenmark Generics
4/3/2012 Percocet Oxycodone and Acetaminophen Endo Pharms Actavis Totowa
4/3/2012 Labetalol Hydrochloride Labetalol Hydrochloride Hospira Gland Pharma
4/3/2012 Valtrex Valacyclovir Hydrocholoride GlaxoSmithKline Jubilant Organosys
4/6/2012 Aldara Imiquimod Medicis Apotex
4/6/2012 Vfrend Voriconazole Pfizer Teva Pharms
4/6/2012 Keppra Levetiracetam UCB Inc Hospira
4/9/2012 Vancocin Hydrochloride Vancomycin Hydrochloride ViroPharma Akorn
4/9/2012 Vancocin Hydrochloride Vancomycin Hydrochloride ViroPharma Strides Arcolab
4/9/2012 Vancocin Hydrochloride Vancomycin Hydrochloride ViroPharma Watson Labs
4/11/2012 Keppra Levetiracetam UCB Vintage Pharms
4/11/2012 Lescol Fluvastatin Sodium Novartis Mylan
4/11/2012 Norco Hydrocodone Bitartrate and Acetaminophen Watson Labs Aurolife Pharma
4/12/2012 DDAVP Desmopressin Acetate Sanofi Aventis US Sun Pharm Inds
4/13/2012 N/A Amino Acids N/A B Braun
4/13/2012 Antivert Meclizine Hydrochloride Pfizer Epic Pharma
4/13/2012 Norvasc Amlodipine Besylate Pfizer Macleods Pharms
4/18/2012 Cisplatin Cisplatin App Pharms Onco Therapies
4/19/2012 Clarinex Desloratadine Schering Plough Belcher Pharms
4/19/2012 Femara Letrozole Novartis Pharms Apotex
4/20/2012 Calan SR Verapamil Hydrochloride Pfizer Apotex
4/23/2012 Zyprexa Olanzapine Lilly Dr Reddys Labs
4/23/2012 Zyprexa Olanzapine Lilly Mylan
4/23/2012 Zyprexa Olanzapine Lilly Apotex
4/23/2012 Zyprexa Olanzapine Lilly Sun Pharm Inds
4/23/2012 Zyprexa Olanzapine Lilly Torrent Pharms
4/23/2012 Zyprexa Olanzapine Lilly Aurobindo Pharma
4/23/2012 Zyprexa Olanzapine Lilly Orchid Hlthcare
4/30/2012 Boniva Ibandronate Sodium Hoffmann La Roche Dr Reddys Labs
4/30/2012 Mirapex Pramipexole Dihydrochloride Boehringer Ingelheim Apotex
4/30/2012 Amerge Naratriptan GlaxoSmithKline Orchid Hlthcare
4/30/2012 Tindamax Tinidazole Mission Pharma Roxane
4/30/2012 Tindamax Tinidazole Mission Pharma Novel Labs
5/1/2012 Neurontin Gabapentin Parke Davis Kiel
5/1/2012 Depo-Testosterone Testosterone Cypionate Pharmacia and Upjohn Hikma Farmaceutica
5/2/2012 Protonix Pantoprazole Sodium Wyeth Apotex
5/2/2012 Protonix Pantoprazole Sodium Wyeth Ranbaxy Labs
5/3/2012 Lexapro Escitalopram Oxalate Forest Labs Taro
5/3/2012 Levitra Vardenafil Hydrochloride Bayer Hlthcare Teva Pharms
5/4/2012 Lamictal Lamotrigine GlaxoSmithKline Glenmark Generics
5/9/2012 Acetazolamide Sodium Acetazolamide Sodium X Gen Pharms Sagent Strides
5/10/2012 Stalevo 100 Carbidopa, Levodopa and Entacapone Orion Pharma Sun Pharma Global
5/11/2012 MS Contin Morphine Sulfate Purdue Pharma Ranbaxy Labs
5/11/2012 Zyrtec Cetirizine Hydrochloride McNeil Consumer Silarx
5/11/2012 Arimidex Anastrozole Astrazeneca Apotex
5/15/2012 Combivir Lamivudine and Zidovudine VIIV Hlthcare Lupin
5/15/2012 Combivir Lamivudine and Zidovudine VIIV Hlthcare Aurobindo Pharma
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Apotex
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Teva
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Mylan
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Roxane
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Sun Pharma Global
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Aurobindo Pharma
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Teva
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Torrent Pharms
5/17/2012 Requip XL Ropinirole Hydrochloride SmithKline Beecham Actavis
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Dr Reddys Labs
5/17/2012 Plavix Clopidogrel Bisulfate Sanofi Aventis US Gate Pharms
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Aurobindo
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Aurobindo
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Cipla
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Strides
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Hetero Labs Ltd III
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Prinston
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Mylan
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Mylan
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Apotex
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Micro Labs
5/22/2012 Viramune Nevirapine Boehringer Ingelheim Sciegen Pharms
5/23/2012 Astelin Azelastine Hydrochloride Meda Pharms Sun Pharma Global
5/23/2012 Ortho Cyclen-28 Mono-Linyah Janssen Pharms Novast Labs
5/23/2012 Ovide Malathion Taro Pharms North Suven Life
5/25/2012 Keppra XR Levetiracetam UCB Inc Boca Pharma
5/29/2012 Lipitor Atorvastatin Calcium Pfizer Sandoz
5/29/2012 Lipitor Atorvastatin Calcium Pfizer Teva Pharms
5/29/2012 Lipitor Atorvastatin Calcium Pfizer Apotex
5/29/2012 Lipitor Atorvastatin Calcium Pfizer Mylan
5/29/2012 Keppra XR Levetiracetam UCB Inc Torrent Pharms
5/29/2012 Carboplatin Carboplatin Watson Labs Onco Therapies
5/30/2012 Ortho Tri-Cyclen Tri-Linyah Janssen Pharms Novast Labs
5/30/2012 Vfend Voriconazole Pfizer Sandoz
5/30/2012 Dovonex Calcipotriene Leo Pharma AS Tolmar
5/30/2012 Cozaar Losartan Potassium Merck Macleods Pharms
5/31/2012 Arimidex Anastrozole Astrazeneca Impax Labs
5/31/2012 Cleocin Phosphate in Dextrose 5% in Plastic Container Clindamycin Phosphate in 5% Dexytrose in Plastic Container Pharmacia and Upjohn Sandoz
5/31/2012 Optivar Azelastine Hydrochloride Meda Pharms Alcon Pharma
5/31/2012 Amerge Naratriptan GlaxoSmithKline Mylan
6/1/2012 Geodon Ziprasidone Hydrochloride Pfizer Sandoz
6/1/2012 Phoslo Gelgaps Calcium Acetate Fresenius Medcl Paddock
6/1/2012 Nuvigil Armodafinil Cephalon Mylan
6/6/2012 Requip XL Ropinirole Hydrochloride SmithKline Beecham Watson Labs
6/6/2012 Requip XL Ropinirole Hydrochloride SmithKline Beecham Sandoz
6/6/2012 Requip XL Ropinirole Hydrochloride SmithKline Beecham Dr Reddys Labs
6/8/2012 Doxycycline Doxycycline Par Pharm Mylan
6/12/2012 Lescol Fluvastatin Sodium Novartis Teva
6/12/2012 Exelon Rivastigmine Tartrate Novartis Alembic Pharms
6/12/2012 Lexapro Escitalopram Oxalate Forest Labs Hetero Labs Ltd III
6/14/2012 Differin Adapalene Galderma Labs LP Tolmar
6/15/2012 Zofran & Zofran Preservative Free Ondansetron Hydrochloride GlaxoSmithKline Gland Pharma
6/15/2012 Theophylline Theophylline Silarx Tris Pharma
6/18/2012 Vancocin Hydrochloride Vancomycin Hydrochloride Viropharma App Pharms
6/18/2012 Ziagen Abacavir Sulfate VIIV Hlthcare Mylan
6/19/2012 Symbyax Olanzapine and Fluoxetine Hydrochloride Lilly Teva
6/20/2012 Amidate Etomidate Hospira Mylan
6/22/2012 Adderall XR 30 Dextroamp Saccharate, AMP Aspartate, Dextroamp Sulfate and AMP Sulfate Shire Actavis Elizabeth
6/25/2012 Thiamine Hydrochloride Thiamine Hydrochloride App Pharms Mylan
6/26/2012 Actoplus Met Pioglitazone Hydrochloride and Metformin Hydrochloride Takeda Global Mylan
6/26/2012 Duac Clindamycin Phosphate; Benzoyl Peroxide Stiefel Perrigo Israel
6/27/2012 Ryzolt Tramadol Hydrochloride Purdue Pharma LP Actavis S Atlantic
6/27/2012 Ryzolt Tramadol Hydrochloride Purdue Pharma LP Anchen Pharms
6/27/2012 Zyvox Linezolid Pharmacia and Upjohn Teva
6/27/2012 Vistide Cidofovir Gilead Sciences Inc. Mylan
6/28/2012 Promethazine Plain Promethazine Hydrochloride Wockhardt Tris Pharma
6/28/2012 Prometh W/ Dextromethorphan Dextromethorphan Hydrobromide; Promethazine Hydrochloride Actavis Mid Atlantic Tris Pharma
6/29/2012 Amaryl Glimepiride Sanofi Aventis US Micro Labs USA
6/29/2012 Xyzal Levocetirizine Dihydrochloride UCB Inc Hetero Labs LTD III
06/29/201 Tussionex Pennkinetic Chlorpheniramine Polistirex; Hydrocodone Polistirex UCB Inc Cornerstone Therapies

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