Drug Approval Package

Definity (Perflutren Lipid Microsphere) Injectable Suspension
Company:  Dupont Pharmaceuticals Company
Application No.:  21-064
Approval Date: 7/31/2001

• Approval Letter(s) (PDF)  

• Printed Labeling (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)
  Part 3 (PDF)  
  Part 4 (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

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

• Correspondence (PDF)

Date created: November 01, 2001

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