Drug Approval Package

Emend (Fosaprepitant Dimeglumine) for Injection
Company:  Merck & Co., Inc.
Application No.:  022023s000
Approval Date: 1/25/2008

• Approval Letter(s) (PDF)
• Approvable Letter (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s)
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
  • Part 4 (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) & Correspondence
• Part 1 (PDF)
• Part 2 (PDF)

Date created: April 21, 2009

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