← FDA DRUG APPROVALS

FDA ANDA · ANDA075795

GLIPIZIDE

Sponsor: APOTEX

APPLICATION
ANDA075795
TYPE
ANDA
ORIGINAL APPROVAL
2001-06-13
LATEST ACTION
2017-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GLIPIZIDEPrescription
GLIPIZIDE 10MG · TABLET · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 5MG · TABLET · ORAL

Approval history

2017-04-18Labeling · Supplement 13 · standardAP
2016-04-26Labeling · Supplement 12 · standardAP
2013-07-26Labeling · Supplement 11 · standardAP
2013-07-26Labeling · Supplement 10 · standardAP
2009-03-25Labeling · Supplement 8AP
2001-06-13OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →