Drug Approval Package
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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
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- 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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