Drug Approval Package

ISENTRESS (raltegravir) 100 mg scored and 25 mg chewable tablets
Company: Merck Sharp & Dohme Corp.
Application No.: 203045
Approval Date: 12/21/2011

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

Date created: April 30, 2012

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