Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.