APPLICATION
ANDA074223
TYPE
ANDA
ORIGINAL APPROVAL
1995-02-27
LATEST ACTION
2026-03-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLIPIZIDEPrescription
GLIPIZIDE 5MG · TABLET · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 10MG · TABLET · ORAL
Approval history
2026-03-30Manufacturing (CMC) · Supplement 27 · unknownAP
2021-05-16Labeling · Supplement 19 · standardAP
2016-01-05Labeling · Supplement 17 · standardAP
2013-07-26Labeling · Supplement 16 · standardAP
2002-06-17Manufacturing (CMC) · Supplement 7AP
2002-06-13Manufacturing (CMC) · Supplement 8AP
2001-09-25Labeling · Supplement 6AP
2001-09-05Manufacturing (CMC) · Supplement 5AP
2000-07-13Manufacturing (CMC) · Supplement 1AP
2000-01-20Labeling · Supplement 4AP
1999-11-10Manufacturing (CMC) · Supplement 2AP
1999-11-05Manufacturing (CMC) · Supplement 3AP
1995-02-27OriginalAP
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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