APPLICATION
ANDA076467
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-08
LATEST ACTION
2019-12-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
GLIPIZIDEPrescription
GLIPIZIDE 2.5MG · TABLET, EXTENDED RELEASE · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-12-17Labeling · Supplement 26 · standardAP
2019-12-17Labeling · Supplement 24 · standardAP
2019-12-17Labeling · Supplement 25 · standardAP
2015-09-10Labeling · Supplement 19 · standardAP
2013-07-31Labeling · Supplement 17 · standardAP
2009-02-18Labeling · Supplement 15AP
2007-03-26Labeling · Supplement 11AP
2006-03-27Labeling · Supplement 6AP
2006-03-27Manufacturing (CMC) · Supplement 5AP
2003-11-07Supplement · Supplement 1AP
2003-09-08OriginalAP
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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