Drug Approval Package

Intelence (Etravirine) Tablets
Company: Tibotec, Inc.
Application No.:  022187
Approval Date: 01/18/2008

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Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  
• Summary Review (PDF)  
• Officer/Employee List (PDF) 
• Office Director Memo (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) 

  • Part 1 (PDF) 
  • Part 2 (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) 

  • Part 1 (PDF) 
  • Part 2 (PDF) 
  • Part 3 (PDF) 
  • Part 4 (PDF) 
  • Part 5 (PDF) 
  • Part 6 (PDF)  

• Risk Assessment and Risk Mitigation Review(s) (PDF)  

• Proprietary Name Review(s) (PDF)  

• Administrative Document(s) & Correspondence 

  • Part 1 (PDF) 
  • Part 2 (PDF)  

Date created: March 17, 2008

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