Drug Approval Package
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Fortamet (Metformin) Extended
Release Tablets
Company: Andrx Labs, Inc.
Application No.: 021574
Approval Date: 4/28/2004
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Approval Letter(s) (PDF)
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Approvable Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
Date created: February 0806
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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