← FDA DRUG APPROVALS

FDA NDA · NDA021178

GLUCOVANCE

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA021178
TYPE
NDA
ORIGINAL APPROVAL
2000-07-31
LATEST ACTION
2018-12-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GLUCOVANCE · ReferenceDiscontinued
GLYBURIDE 2.5MG, METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLUCOVANCE · ReferenceDiscontinued
GLYBURIDE 5MG, METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLUCOVANCE · ReferenceDiscontinued
GLYBURIDE 1.25MG, METFORMIN HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2018-12-27Labeling · Supplement 18 · standard — Letter ↗AP
2017-04-05Labeling · Supplement 16 · standard — Label ↗AP
2017-04-05Labeling · Supplement 17 · 901 required — Label ↗AP
2013-10-15Labeling · Supplement 15 · standard — Letter ↗AP
2013-08-15Manufacturing (CMC) · Supplement 14 · standardAP
2013-03-14Manufacturing (CMC) · Supplement 13 · standardAP
2010-11-24Labeling · Supplement 12 · unknown — Letter ↗AP
2009-11-24Labeling · Supplement 11 · standard — Label ↗AP
2008-09-16Labeling · Supplement 10 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 9 · standard — Label ↗AP
2004-03-15Efficacy · Supplement 7 · priority — Pediatric Medical Review ↗AP
2002-09-30Efficacy · Supplement 4 · standard — Label ↗AP
2002-07-08Manufacturing (CMC) · Supplement 3 · standardAP
2002-07-02Manufacturing (CMC) · Supplement 5 · standardAP
2001-02-28Labeling · Supplement 2 · standardAP
2000-12-13Manufacturing (CMC) · Supplement 1 · standardAP
2000-07-31Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Letter ↗AP
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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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