Drug Approval Package

 MENTAX TC (Butenafine HCI) Cream
Company:  Bertek Pharmaceuticals, Inc.
Application No.:  021408
Approval Date: 10/17/2002

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Microbiology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: January 312006

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.