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ANDA Approvals
Summer 2012
| 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 |
GENERICally Speaking Summer 2012
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