Drug Approval Package

Solaraze (Diclofenac Sodium) Gel
Company:  SkyePharma Inc.
Application No.:  21-005
Approval Date: 10/16/2000

• Approval Letter(s) (PDF)  

• Printed Labeling (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)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  

Date created: July 08, 2003

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