APPLICATION
ANDA076345
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-18
LATEST ACTION
2021-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 1.25MG, METFORMIN HYDROCHLORIDE 250MG · TABLET · ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
Approval history
2021-06-24Labeling · Supplement 36 · standardAP
2021-06-24Labeling · Supplement 34 · standardAP
2015-04-08Labeling · Supplement 32 · standardAP
2015-04-08Labeling · Supplement 19AP
2014-02-04Labeling · Supplement 26AP
2011-09-27Labeling · Supplement 30AP
2010-04-27Labeling · Supplement 29AP
2009-03-16Labeling · Supplement 23AP
2008-12-05Labeling · Supplement 22AP
2007-11-21Labeling · Supplement 13AP
2007-07-27Labeling · Supplement 16AP
2006-03-02Labeling · Supplement 7AP
2005-07-26Labeling · Supplement 5AP
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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