Drug Approval Package

Voltaren Gel (diclofenac sodium) 1%
Company: Novartis
NDA: 022122
Approval Date: 10/17/2007

• Approval Letter (PDF)
• Printed Labeling (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Medical Review(s)
  • Part 1 (PDF)  
  • Part 2 (PDF)  
  • Part 3 (PDF)   
• Chemistry Review(s) (PDF)
• Pharmacology Review(s)
  • Part 1 (PDF)  
  • Part 2 (PDF)  
  • Part 3 (PDF)   
• Statistical Review(s) (PDF)  
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) and Correspondence
  • Part 1 (PDF)  
  • Part 2 (PDF)

Date created: February 22, 2008

Back to Top    Drugs@FDA

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