Drug Approval Package

Zofran (Ondansetron) Tablets
Company:  Glaxo Wellcome Inc.
Application No.:  020103/S015
Approval Date: 8/27/1999

• Approval Letter(s) (PDF) (772 KB)

• Medical Review(s)
  Part 1 (PDF) (2.2 MB)
  Part 2 (PDF) (2.4 MB)
  Part 3 (PDF) (2.6 MB)
  Part 4 (PDF) (2.5 MB)

• Chemistry Review(s) (PDF) (592 KB)

• Statistical Review(s)
  Part 1 (PDF) (1.8 MB)
  Part 2 (PDF) (2.1 MB)

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (PDF) (2.6 MB)
  Part 2 (PDF) (3 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (1.8 MB)
  Part 2 (PDF) (3 MB)

Date created: March 30, 2001

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