Drug Approval Package

Mepron (Atovaquone) Suspension
Company:  Glaxo Wellcome, Inc.
Application No.:  20-500/S-005
Approval Date: 1/5/1999

• Approval Letter & Printed Labeling (PDF) (2.1 MB)

• Medical/Statistical Review(s)
  Part 1 (PDF) (2.5 MB)
  Part 2 (PDF) (2.4 MB)
  Part 3 (PDF) (2.9 MB)
  Part 4 (PDF) (2 MB)

• Chemistry Review(s) Microbiology Review(s) Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.2 MB)

• Administrative Document(s)/Correspondence (PDF) (3 MB)

Date created: March 30, 2001; last update: July 5, 2005

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