APPLICATION
ANDA090937
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-28
LATEST ACTION
2016-01-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLYBURIDEPrescription
GLYBURIDE 2.5MG · TABLET · ORAL
GLYBURIDEPrescription
GLYBURIDE 5MG · TABLET · ORAL
GLYBURIDEPrescription
GLYBURIDE 1.25MG · TABLET · ORAL
Approval history
2016-01-05Labeling · Supplement 6 · standardAP
2015-02-18Labeling · Supplement 4 · standardAP
2012-09-27Labeling · Supplement 3 · standardAP
2011-08-25Labeling · Supplement 2AP
2011-05-31Labeling · Supplement 1AP
2011-02-28OriginalAP
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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