Drug Approval Package

 Ketek (Telithromycin) Tablets
Company:  Aventis Pharmaceuticals, Inc.
Application No.:  021144
Approval Date: 4/01/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)  
  Part 7 (PDF)  
  Part 8 (PDF)  
  Part 9 (PDF)  
  Part 10 (PDF)  
  Part 11 (PDF)  

• Chemistry Review(s) (PDF)

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

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

• Microbiology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)

• Administrative Document(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)

• Correspondence (PDF)  

Date created: July 072004

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