Drug Approval Package

 Xanax X-R (Alprazolam) Extended-Release Tablets
Company:  Pharmacia & Upjohn
Application No.:  021434
Approval Date: 1/17/2003

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Statistical Review(s) (PDF)

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

• Administrative Document(s) & Correspondence (PDF)  

Date created: December 062004

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