Drug Approval Package
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U.S. Department of Health and Human Services

Drug Approval Package

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Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
tablets, 5 mg saxagliptin/500 mg metformin hydrochloride extended-release, 5 mg saxagliptin/1000 mg metformin hydrochloride extended-release, and 2.5 mg saxagliptin/1000 mg metformin hydrochloride extended-release
Company: Bristol-Myers Squibb Company
Application No.: 200678
Approval Date: 11/05/2010

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Date created: September 16, 2011

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