Drug Approval Package

Avandia (Rosiglitazone Maleate) Tablets
Company:  SmithKline Beecham
Application No.:  21-071/S001
Approval Date: 4/4/2000

• Approval Letter(s)(PDF)  

• Printed Labeling(PDF)  

• Medical Review(s)(PDF)  

• Chemistry Review(s)(PDF)

• Pharmacology Review(s)(PDF)  

• Statistical Review(s)(PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s)(PDF)  

• Administrative Document(s)(PDF)

• Correspondence(PDF)  

Date created: November 20, 2001

Back to Top    Drugs@FDA

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