Drug Approval Package

Penlac Nail Lacquer Tropical Solution
Company:  Aventis Pharmaceuticals, Inc.
Application No.:  21-022
Approval Date: 12/17/1999

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) 
  Part 1 (PDF)  
  Part 2 (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) (PDF)  

• Correspondence 
  Part 1 (PDF)  
  Part 2 (PDF)

Date created: August 20, 2002

Back to Top    Drugs@FDA

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