Drug Approval Package

Pristiq (Desvenlafaxine Succinate) Extended Release Tablets
Company: Wyeth Pharmaceuticals, Inc.
Application No.:  021992
Approval Date: 02/29/2008

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Approval Letter(s) (PDF) 


• Approvable Letter (PDF) 

• Printed Labeling (PDF) 

• Summary Review (PDF) 

• Officer/Employee List (PDF) 
• Office Director Memo (PDF) 
• Medical Review(s) (PDF) 
  • Part 1 (PDF) 
  • Part 2 (PDF)  

• Chemistry Review(s) (PDF) 

• Environmental Assessment (PDF) 

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

• Statistical Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

  • Part 1 (PDF) 
  • Part 2 (PDF) 
  • Part 3 (PDF)
  • Part 4 (PDF) 
  • Part 5 (PDF) 
  • Part 6 (PDF)
  • Part 7 (PDF) 
  • Part 8 (PDF)  
• Proprietary Name Review(s) (PDF) 
• Risk Assessment and Risk Mitigation Review(s) (PDF) 
• Administrative Document(s) & Correspondence (PDF) 

Date created: June 13, 2008

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