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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-842GRANISETRON HYDROCHLORIDE TABLETS, 1 MG (BASE)ROXANE LABORATORIES, INC.12/7/2006 
278-127ONDANSETRON ORAL SOLUTION USP, 4 MG/5 MLAPOTEX INC.12/11/2006 
377-522TRANDOLAPRIL TABLETS, 1 MG 2 MG 4 MGLUPIN PHARMACEUTICALS, INC12/12/2006 
477-415BUPROPION HCL EXTENDED-RELEASE TABLETS USP, 150 MGIMPAX LABORATORIES, INC.12/15/2006 
577-512ESCITALOPRAM OXALATE TABLETS, 5 MG (BASE), 10 MG (BASE), AND 20 MG (BASE)ACTAVIS ELIZABETH LLC12/18/2006 
677-306ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE) AND 8 MG (BASE)APOTEX INC.12/19/2006 
778-064EFAVIRENZ CAPSULES, 50 MG, 100 MG, AND 200 MGAUROBINDO PHARMA LIMITED12/19/2006 
878-026PAROXETINE TABLETS USP, 10 MG, 20 MG, 30 MG, AND 40 MGROXANE LABORATORIES, INC.12/19/2006 
978-032ESCITALOPRAM OXALATE TABLETS, 5 MG (BASE), 10 MG (BASE), AND 20 MG (BASE)KALI LABORATORIES, INC.12/27/2006 
1077-670SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)LUPIN LIMITED12/28/2006 
1177-410NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 90 MGOSMOTICA PHARMACEUTICAL CORP.12/28/2006 
1277-107DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS, 2.5 MG, 5 MG, AND 10 MGTEVA PHARMACEUTICALS USA12/29/2006 
1376-935MODAFINIL TABLETS, 100 MG AND 200 MGSANDOZ INC.12/29/2006 
1477-667MODAFINIL TABLETS, 100 MG AND 200 MGAPOTEX INC.12/29/2006