Drug Approval Package

Zofran (Ondansetron HCL) Injection & Injection Premixed
Company:  GlaxoWellcome Inc.
Application No.:  20-007/S22 & 20-403/S5
Approval Date: 10/31/1997

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)

Date created: April 30, 2002

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