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www.fdanews.com/articles/68217-teva-gets-approval-for-glyburide-metformin-hcl-tablets

Teva Gets Approval for Glyburide/Metformin HCl Tablets

February 1, 2005

Teva Pharmaceutical has been granted final approval from the FDA for the its abbreviated new drug application for Glyburide and Metformin HCl tablets, 1.25 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg.

Shipment of this product is expected to begin shortly.

Teva's Glyburide and Metformin HCl tablets are the AB-rated generic equivalent of Bristol-Myers Squibb's Glucovance tablets, a product indicated as an adjunct to diet and exercise in the treatment of Type 2 diabetes.