FDAnews Drug Daily Bulletin

RANBAXY GETS US FDA NOD FOR CEFPROZIL

July 5, 2006
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Ranbaxy has received approval from the US FDA to manufacture and market Cefprozil for Oral Suspension USP, 125 mg/5mL and 250 mg/5mL, said the company press release. The Office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and having the same therapeutic effect as that of the reference listed drug Cefzil for Oral Suspension by Bristol Myers Squibb Company Pharmaceutical Research Institute.
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