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FDA NDA · NDA020329

GLUCOTROL XL

glipizide

Sponsor: PFIZER

APPLICATION
NDA020329
TYPE
NDA
ORIGINAL APPROVAL
1994-04-26
LATEST ACTION
2021-08-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued, Prescription

Products

GLUCOTROL XL · ReferenceDiscontinued
GLIPIZIDE 2.5MG · TABLET, EXTENDED RELEASE · ORAL
GLUCOTROL XL · ReferencePrescription
GLIPIZIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
GLUCOTROL XL · ReferencePrescription
GLIPIZIDE 10MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-08-03Manufacturing (CMC) · Supplement 35 — Letter ↗AP
2018-08-10Labeling · Supplement 32 · standard — Label ↗AP
2017-08-16Labeling · Supplement 30 · standard — Label ↗AP
2015-10-05Labeling · Supplement 29 · standard — Label ↗AP
2013-10-15Labeling · Supplement 28 · standard — Label ↗AP
2011-02-07Labeling · Supplement 25 · unknown — Label ↗AP
2009-08-31Labeling · Supplement 24 · standard — Label ↗AP
2008-10-27Labeling · Supplement 22 · standard — Label ↗AP
2003-09-17Labeling · Supplement 15 · standard — Review ↗AP
2002-04-01Efficacy · Supplement 2 · standard — Label ↗AP
2001-10-26Labeling · Supplement 13 · standardAP
2001-09-05Labeling · Supplement 6 · standardAP
2001-06-25Manufacturing (CMC) · Supplement 12 · standardAP
2001-01-16Manufacturing (CMC) · Supplement 10 · standardAP
2000-10-31Manufacturing (CMC) · Supplement 11 · standardAP
2000-10-26Manufacturing (CMC) · Supplement 8 · standardAP
2000-07-26Manufacturing (CMC) · Supplement 9 · standardAP
2000-04-17Manufacturing (CMC) · Supplement 7 · standardAP
1999-12-15Manufacturing (CMC) · Supplement 5 · standardAP
1999-11-18Manufacturing (CMC) · Supplement 4 · standardAP
1999-08-10Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1998-02-04Efficacy · Supplement 1 · standardAP
1994-04-26Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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