APPLICATION
NDA017783
TYPE
NDA
ORIGINAL APPROVAL
1984-05-08
LATEST ACTION
2016-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLUCOTROL · ReferenceDiscontinued
GLIPIZIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLUCOTROL · ReferenceDiscontinued
GLIPIZIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLUCOTROL · ReferenceDiscontinued
GLIPIZIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1999-12-15Manufacturing (CMC) · Supplement 16 · standardAP
1999-08-06Labeling · Supplement 15 · standardAP
1997-12-11Manufacturing (CMC) · Supplement 14 · standardAP
1993-11-24Manufacturing (CMC) · Supplement 13 · standardAP
1993-05-19Labeling · Supplement 12 · standardAP
1993-05-11Manufacturing (CMC) · Supplement 11 · standardAP
1991-08-06Manufacturing (CMC) · Supplement 10 · standardAP
1987-05-14Manufacturing (CMC) · Supplement 9 · standardAP
1987-03-31Labeling · Supplement 8AP
1987-03-04Manufacturing (CMC) · Supplement 6 · standardAP
1986-09-15Manufacturing (CMC) · Supplement 7 · standardAP
1985-11-18Labeling · Supplement 4AP
1985-10-22Manufacturing (CMC) · Supplement 3 · standardAP
1985-10-16Manufacturing (CMC) · Supplement 5 · standardAP
1985-03-15Manufacturing (CMC) · Supplement 2 · standardAP
1984-05-08Type 1 - New Molecular Entity · Original · standardAP
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.