Print

ANDA Approvals

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

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.