Drug Approval Package

Urso (Ursodiol) Tablets
Company:  Axcan Pharma U.S. Inc.
Application No.:  020675
Approval Date: 12/10/97

• Approval Letter(s) (PDF) (212 KB)

• Medical Review(s)

  Part 1 (PDF) (2.5 MB)	Part 3 (PDF) (2.3 MB)	Part 5 (PDF) (2.5 MB)
  Part 2 (PDF) (2.5 MB)	Part 4 (PDF) (1.9 MB)	Part 6 (PDF) (2.6 MB)

• Pharmacology Review(s)

  Part 1 (PDF) (1.7 MB)	Part 4 (PDF) (2.7 MB)	Part 7 (PDF) (2.5 MB)
  Part 2 (PDF) (2.4 MB)	Part 5 (PDF) (2.6 MB)	Part 8 (PDF) (2.7 MB)
  Part 3 (PDF) (2.3 MB)	Part 6 (PDF) (2.4 MB)

• Statistical Review(s)
  Part 1 (PDF) (1 MB)
  Part 2 (PDF) (2.8 MB)

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (PDF) (1.8 MB)
  Part 2 (PDF) (1.6 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (2.3 MB)
  Part 2 (PDF) (2 MB)

Date created: January 18, 2006

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