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
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- 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
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-