Drug Approval Package

JANUMET XR (sitagliptin/metformin hydrochloride extended release) fixed-dose combination tablets, 100 mg/1000 mg, 50 mg/500 mg, and 50 mg/1000 mg
Company: Merck Sharp & Dohme Corp.
Application No.: 202270
Approval Date: 02/02/2012

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review (PDF)
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: September 3, 2013

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