Drug Approval Package
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Glucophage (Metformin Hydrochloride) Tablets
Company: Bristol-Myers Squibb
Application No.: 020357/S010
Approval Date: 10/22/1998
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Approval Letter, Medical Review(s), Chemistry Review(s), & EA/Fonsi (PDF) (1.8 MB)
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Statistical Review(s) (PDF) (1.9 MB)
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Administrative Document(s)/Correspondence (PDF) (2 MB)
Last updated: July 1, 2005
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