APPLICATION
NDA017498
TYPE
NDA
ORIGINAL APPROVAL
1984-05-01
LATEST ACTION
2015-05-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MICRONASE · ReferenceDiscontinued
GLYBURIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MICRONASE · ReferenceDiscontinued
GLYBURIDE 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MICRONASEDiscontinued
GLYBURIDE 2.5MG · TABLET · ORAL
Approval history
1999-11-30Manufacturing (CMC) · Supplement 23 · standardAP
1999-10-28Labeling · Supplement 21 · standardAP
1997-06-27Manufacturing (CMC) · Supplement 20 · standardAP
1997-04-02Labeling · Supplement 19 · standardAP
1997-04-02Labeling · Supplement 18 · standardAP
1995-09-28Manufacturing (CMC) · Supplement 15 · standardAP
1995-09-28Manufacturing (CMC) · Supplement 16 · standardAP
1993-01-21Labeling · Supplement 14 · standardAP
1992-07-27Labeling · Supplement 13AP
1991-11-15Manufacturing (CMC) · Supplement 11 · standardAP
1990-12-14Labeling · Supplement 12AP
1988-04-27Manufacturing (CMC) · Supplement 10 · standardAP
1988-03-02Manufacturing (CMC) · Supplement 8 · standardAP
1988-01-05Labeling · Supplement 9AP
1987-06-25Labeling · Supplement 7AP
1987-04-07Labeling · Supplement 6AP
1986-03-24Labeling · Supplement 5AP
1986-03-18Manufacturing (CMC) · Supplement 4 · standardAP
1985-07-24Manufacturing (CMC) · Supplement 2 · standardAP
1985-01-15Manufacturing (CMC) · Supplement 1 · standardAP
1984-05-01Type 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.
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