Drug Approval Package

Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride extended-release) fixed-dose combination tablets, 15mg/1000 mg and 30 mg/1000 mg
Company: Takeda Global Research & Development Center Inc.
Application No.: 022024
Approval Date: 5/12/2009

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

Date created: March 25, 2010

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