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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2006

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-842 GRANISETRON HYDROCHLORIDE TABLETS, 1 MG (BASE) ROXANE LABORATORIES, INC. 12/7/2006 
2 78-127 ONDANSETRON ORAL SOLUTION USP, 4 MG/5 ML APOTEX INC. 12/11/2006 
3 77-522 TRANDOLAPRIL TABLETS, 1 MG 2 MG 4 MG LUPIN PHARMACEUTICALS, INC 12/12/2006 
4 77-415 BUPROPION HCL EXTENDED-RELEASE TABLETS USP, 150 MG IMPAX LABORATORIES, INC. 12/15/2006 
5 77-512 ESCITALOPRAM OXALATE TABLETS, 5 MG (BASE), 10 MG (BASE), AND 20 MG (BASE) ACTAVIS ELIZABETH LLC 12/18/2006 
6 77-306 ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE) AND 8 MG (BASE) APOTEX INC. 12/19/2006 
7 78-064 EFAVIRENZ CAPSULES, 50 MG, 100 MG, AND 200 MG AUROBINDO PHARMA LIMITED 12/19/2006 
8 78-026 PAROXETINE TABLETS USP, 10 MG, 20 MG, 30 MG, AND 40 MG ROXANE LABORATORIES, INC. 12/19/2006 
9 78-032 ESCITALOPRAM OXALATE TABLETS, 5 MG (BASE), 10 MG (BASE), AND 20 MG (BASE) KALI LABORATORIES, INC. 12/27/2006 
10 77-670 SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) LUPIN LIMITED 12/28/2006 
11 77-410 NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 90 MG OSMOTICA PHARMACEUTICAL CORP. 12/28/2006 
12 77-107 DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS, 2.5 MG, 5 MG, AND 10 MG TEVA PHARMACEUTICALS USA 12/29/2006 
13 76-935 MODAFINIL TABLETS, 100 MG AND 200 MG SANDOZ INC. 12/29/2006 
14 77-667 MODAFINIL TABLETS, 100 MG AND 200 MG APOTEX INC. 12/29/2006 
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