Drug Approval Package

Samsca (Tolvaptan) Tablets
Company:  Otsuka Pharmaceutical Company, Ltd.
Application No.:  022275
Approval Date: 5/19/2009

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Office Director Memo (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
  • Part 1 (PDF)
  • Part 2 (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
  • Part 4 (PDF)
  • Part 5 (PDF)
  • Part 6 (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: July 21, 2009

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