Drug Approval Package

Extina (ketoconazole) Foam, 2%
Company: Stiefel Laboratories, Inc.
NDA: 021738
Approval Date: 6/12/2007

• Approvable Letter(s) (PDF)
• 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)
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) and Correspondence (PDF)
  
  • Part 1 (PDF)
  • Part 2 (PDF)

Date created: January 22, 2009

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