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U.S. Department of Health and Human Services

Drugs

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Approvals - February 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 77-039 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   MYLAN PHARMACEUTICALS, INC. 2/3/2005 
2 65-205 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, (CHEWABLE 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE)   TEVA PHARMACEUTICALS USA 2/9/2005 
3 77-155 FENOLDOPAM MESYLATE INJECTION, USP 10 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 20 MG (BASE)/2 ML SINGLE-DOSE AMPULES   SABEX 2002 INC. 2/15/2005 
4 40-547 METHIMAZOLE TABLETS, USP 5 MG, 10 MG, AND 20 MG   CEDAR PHARMACEUTICALS LLC 2/18/2005 
5 76-712 TERCONAZOLE VAGINAL CREAM 0.4%   ALTANA INC. 2/18/2005 
6 40-557 METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP 40 MG/ML AND 80 MG/ML   SICOR PHARMACEUTICALS, INC. 2/23/2005 
7 40-586 PRIMIDONE TABLETS, USP 50 MG AND 250 MG   VINTAGE PHARMACEUTICALS, LLC 2/24/2005 
8 40-607 ACETIC ACID OTIC SOLUTION, USP 2%   VINTAGE PHARMACEUTICALS, LLC 2/24/2005 
9 65-152 CEPHALEXIN CAPSULES, USP 250 MG AND 500 MG   YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO., 2/24/2005 
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