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FDA NDA · NDA020051

GLYNASE

Sponsor: PFIZER

APPLICATION
NDA020051
TYPE
NDA
ORIGINAL APPROVAL
1992-03-04
LATEST ACTION
2017-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GLYNASE · ReferenceDiscontinued
GLYBURIDE 6MG · TABLET · ORAL
GLYNASE · ReferenceDiscontinued
GLYBURIDE 3MG · TABLET · ORAL
GLYNASE · ReferenceDiscontinued
GLYBURIDE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLYNASE · ReferenceDiscontinued
GLYBURIDE 1.5MG · TABLET · ORAL

Approval history

2017-08-22Labeling · Supplement 22 · standard — Label ↗AP
2015-05-22Labeling · Supplement 21 · standard — Letter ↗AP
2013-10-15Labeling · Supplement 20 · standard — Letter ↗AP
2011-02-07Labeling · Supplement 17 · unknown — Letter ↗AP
2009-08-27Labeling · Supplement 16 · standard — Letter ↗AP
2008-10-29Labeling · Supplement 13 · standard — Letter ↗AP
1999-11-30Manufacturing (CMC) · Supplement 10 · standardAP
1999-10-28Labeling · Supplement 9 · standardAP
1997-04-18Labeling · Supplement 7 · standardAP
1997-01-10Labeling · Supplement 8 · standard — Review ↗AP
1996-02-21Labeling · Supplement 4 · standardAP
1993-09-24Manufacturing (CMC) · Supplement 2 · standardAP
1993-01-21Labeling · Supplement 3 · standardAP
1992-06-08Manufacturing (CMC) · Supplement 1 · standardAP
1992-03-04Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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