Drug Approval Package
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Glumetza (Metformin Hydrochloride) Extended-Release Tablets
Company: Biovail Laboratories Inc.
Application No.: 021748
Approval Date: 06/03/2005
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Approval 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: September 072006
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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