Drug Approval Package

DUAC (clindamycin, benzyoyl) Gel
Company: Stiefel Laboratories
Application No.:  050741
Approval Date: 8/26/2002

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  
  

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

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  
  

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

• Microbiology Review(s) (PDF)   
  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
  

• Administrative Document(s) & Correspondence (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)

Date created: April 27, 2003

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