Drug Approval Package

Xyrem (Sodium Oxybate) Oral Solution
Company:  Orphan Medical
Application No.:  21-196
Approval Date: 7/17/2002

• Approval Letter(s) (PDF)  

• Printed Labeling
  Part 1 (PDF)  
  Part 2 (PDF)  

• Medical Review(s) 

  Part 1 (PDF)	Part 6 (PDF)	Part 11 (PDF)
  Part 2 (PDF)	Part 7 (PDF)	Part 12 (PDF)
  Part 3 (PDF)	Part 8 (PDF)	Part 13 (PDF)
  Part 4 (PDF)	Part 9 (PDF)	Part 14 (PDF)
  Part 5 (PDF)	Part 10 (PDF)	Part 15 (PDF)

• Chemistry Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Pharmacolgy Review(s) (PDF)  

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

• Administrative Document(s) (PDF)

Date created: October 23, 2002

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