APPLICATION
ANDA079009
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-03
LATEST ACTION
2025-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 1.25MG, METFORMIN HYDROCHLORIDE 250MG · TABLET · ORAL
Approval history
2025-06-20Labeling · Supplement 5 · standardAP
2025-06-20Labeling · Supplement 11 · standardAP
2015-02-18Labeling · Supplement 3 · standardAP
2009-06-03OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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