Drug Approval Package

 Tykerb (Lapatinib) Tablets
Company: SmithKlineBeecham Corporation d/b/a GlaxoSmithKline
Application No.:  022059
Approval Date: 03/13/2007

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

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

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

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

Date created: May 09, 2007

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