FDA Approval Activities for this Drug…

Sulfamylon (mafenide acetate, USP) Powder Topical Solution, 5% Mylan NDA 19-832/S2 & S3 7/12/01 2/14/02 Sulfamylon (mafenide acetate, USP) Powder for 5% Topical Solution Mylan NDA 19-832 6/5/98 6/9/98 6/9/98 1/6/99 Sulfamylon Indication: for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. MAFENIDE ACETATE Cream; Topical 85MG BASE/GM SULFAMYLON BERTEK 019832 MAFENIDE ACETATE For Solution; Topical 5% SULFAMYLON Mylan

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