Drug Approval Package

Bumex (bumetanide) Tablets & Bumex (bumetanide) Injection
Company:  Hoffmann-La Roche Inc.
Application No.:  18-225/S18/S19 & 18-226/S24/S25
Approval Date: 10/29/02

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)

Date created: March 07, 2003

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