Drug Approval Package

 Invega (Paliperidone) Extended- Release Tablets
Company: Jansen
Application No.:  021999
Approval Date: 12/19/2006

• 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)  

• Chemistry Review(s) (PDF)    

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)      

• Statistical Review(s) (PDF)  

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

• Administrative Document(s) & Correspondence (PDF)  

Date created: March 302007

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