Drug Approval Package

 Busulfex (Busulfan ) Injection
Company:  Orphan Medical, Inc.
Application No.:  020954/S004
Approval Date: 6/28/2002

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

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

• Chemistry Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  

Date created: June 042004

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