Drug Approval Package

 Velcade (Bortezomib) Injection
Company:  Millennium Pharmaceuticals Inc.
Application No.:  021602
Approval Date: 5/13/2003

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  

• Microbiology Review(s) (PDF)  

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

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

• Correspondence 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  

 

Date created: April 04, 2002

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