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FDA Information

Cefprozil has been approved by the Food and Drug Administration.

In December 2005, Lupin Ltd. announced that it had received US FDA approval for its Abbreviated New Drug Application (ANDA) for Cefprozil Oral Suspension, 125 mg/5 ml and 250 mg/5 ml. Cefprozil is the generic equivalent of Bristol Myers Squibb’s Cefzil®. The suspension market in the US is USD 119 million as per IMS MAT June 2005 data. Earlier, the Company received approval from the US FDA for Cefprozil tablets.

 

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