Drug Approval Package

 Pravagard PAC Tablets
Company:  Bristol-Myers Squibb Co.
Application No.:  021387
Approval Date: 6/24/2003

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

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

• Chemistry Review(s) (PDF)

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

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

• Correspondence (PDF)

Date created: January /29/2004

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