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U.S. Department of Health and Human Services

Drugs

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Approvals - February 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
177-039CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  MYLAN PHARMACEUTICALS, INC.2/3/2005 
265-205AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, (CHEWABLE 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE)  TEVA PHARMACEUTICALS USA2/9/2005 
377-155FENOLDOPAM 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 
440-547METHIMAZOLE TABLETS, USP 5 MG, 10 MG, AND 20 MG  CEDAR PHARMACEUTICALS LLC2/18/2005 
576-712TERCONAZOLE VAGINAL CREAM 0.4%  ALTANA INC.2/18/2005 
640-557METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP 40 MG/ML AND 80 MG/ML  SICOR PHARMACEUTICALS, INC.2/23/2005 
740-586PRIMIDONE TABLETS, USP 50 MG AND 250 MG  VINTAGE PHARMACEUTICALS, LLC2/24/2005 
840-607ACETIC ACID OTIC SOLUTION, USP 2%  VINTAGE PHARMACEUTICALS, LLC2/24/2005 
965-152CEPHALEXIN CAPSULES, USP 250 MG AND 500 MG  YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO.,2/24/2005