Drug Approval Package

Glucophage XR (Metformin Hydrochloride) Extended Release Tablets
Company:  Bristol-Myers Squibb Co.
Application No.:  21-202
Approval Date: 10/13/2000

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  

Date created: February 03, 2003

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