Drug Approval Package

Malarone (atovaquone and proguaril hydrochloride) Tablets
Company:  Glaxo Wellcome
Application No.:  021078
Approval Date: 7/14/2000

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)

• Statistical Review(s) (PDF)

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)

• Correspondence
  Part 1 (PDF)  
  Part 2 (PDF)  

Date created: June 16, 2003

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.