Drug Approval Package

Drug Name: Isentress (raltegravir) 400mg Tablets
Company: Merck & Company, Inc.
NDA: 022145
Approval Date: 10/12/2007

• 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)  
• Chemistry Review(s) (PDF)
• Pharmacology Review(s)
  • Part 1 (PDF)  
  • Part 2 (PDF)   
• Statistical Review(s) (PDF) 
• Microbiology Review(s) (PDF) 
• Clinical Pharmacology Biopharmaceutics Review(s)
  • Part 1 (PDF)  
  • Part 2 (PDF)  
• Risk Assessment and Risk Mitigation Review(s) (PDF)
  
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) and Correspondence
  • Part 1 (PDF)  
  • Part 2 (PDF)  

Date created: February 22, 2008

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