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… Mentax (Butenafine HCl) Cream, 1%, Bertek NDA 20-524/S005 6/6/01 11/6/01 11/6/01 11/20/01 Mentax Indications: for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum orbiculare). Mentax TC (Butenafine HCl) Cream, 1%, Bertek NDA 21-408   For the latest approval information, locate this drug using this index.