APPLICATION
ANDA074497
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-31
LATEST ACTION
2019-12-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLIPIZIDEPrescription
GLIPIZIDE 5MG · TABLET · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 10MG · TABLET · ORAL
Approval history
2019-12-20Labeling · Supplement 28 · standardAP
2019-12-20Labeling · Supplement 29 · standardAP
2011-05-25Labeling · Supplement 25AP
2010-01-27Labeling · Supplement 20AP
2009-03-11Labeling · Supplement 18AP
2008-04-25Labeling · Supplement 15AP
2002-07-29Manufacturing (CMC) · Supplement 7AP
2002-04-29Manufacturing (CMC) · Supplement 6AP
2001-09-12Manufacturing (CMC) · Supplement 5AP
2000-05-31Manufacturing (CMC) · Supplement 3AP
2000-05-31Labeling · Supplement 4AP
2000-01-28Manufacturing (CMC) · Supplement 2AP
1998-10-20Manufacturing (CMC) · Supplement 1AP
1995-08-31OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.