Drug Approval Package

ISENTRESS (raltegravir) for Oral Suspension,
Company:  Merck Sharp & Dohme Corp.
Application No.:  205786
Approval Date: 12/20/2013

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• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: June 27, 2014

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