Drug Approval Package

Gleevec (Imatinib Mesylate) Capsules
Company:  Novartis Pharmaceuticals Corporation
Application No.:  21-335
Approval Date: 5/10/2001

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

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

• Statistical Review(s) (PDF)  

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

• Administrative Document(s) (PDF)  

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

Date created: October 17, 2001

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