Drug Approval Package

Solage (Mequinol 2%/Tretinoin, .01%) Topical Solution
Company:  Bristol-Myers Squibb Pharmaceutical Research Institute
Application No.:  20-922
Approval Date: 12/10/1999

• 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)  
  Part 3 (PDF)

Date created: April 10, 2002

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