Drug Approval Package

Hycamtin (topotecan) Capsules, 0.25 mg and 1 mg
Company: Smithkline Beecham Corporation
NDA: 020981
Approval Date: 10/11/2007

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Summary Review (PDF)
• Medical Review(s)
  • Part 1 (PDF)  
  • Part 2 (PDF)   
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) and Correspondence (PDF)
  

Date created: January 15, 2009

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