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Rhone-Poulenc Rorer Azmacort HFA

Executive Summary

Triamcinolone CFC-free inhaled steroid is deemed "approvable" by FDA April 30, for the second time. NDA 20-836 was originally submitted March 5, 1997 and was first "approvable" in March 1998. RPR submitted additional clinical data to the agency in response, which FDA accepted; the remaining issues are related to chemistry, manufacturing and controls. RPR says it will discuss with the agency what additional information is needed

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