Drug Approval Package

Avandamet (rosiglitazone maleate/metformin HCL) Tablets
Company:  GlaxoSmithKline
Application No.:  021410
Approval Date: 10/10/2002

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
  

• Administrative Document(s) (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  
  

• Administrative Document(s) & Correspondence (PDF)

Date created: April 30, 2003

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