Drug Approval Package

Treanda (bendamustine hydrochloride)
Company: Cephalon, Inc.
NDA: 22-249
Approval Date: 3/20/2008

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

• Approval Letter(s)(PDF)
• Printed Labeling(PDF)
• Summary Review(PDF)
• Officer/Employee List  (PDF)
• Office Director Memo(PDF)  
• Cross Discipline Team Leader Review(PDF)
• Medical Review(s)
  
  • Part 1(PDF)  
  • Part 2(PDF)   
• Chemistry Review(s)(PDF)
• Pharmacology Review(s)
• Statistical Review(s)
• Microbiology Review(s)
• Proprietary Name Review(s)(PDF)
• Administrative Document(s) and Correspondence(PDF)

Date created: May 8, 2008

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