APPLICATION
NDA020055
TYPE
NDA
ORIGINAL APPROVAL
1992-04-17
LATEST ACTION
2000-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 3MG · TABLET · ORAL
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 6MG · TABLET · ORAL
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 1.5MG · TABLET · ORAL
Approval history
2000-03-08Manufacturing (CMC) · Supplement 7 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 6 · standardAP
1998-12-04Manufacturing (CMC) · Supplement 5 · standardAP
1997-12-24Manufacturing (CMC) · Supplement 4 · standardAP
1997-05-13Manufacturing (CMC) · Supplement 3 · standardAP
1995-02-07Manufacturing (CMC) · Supplement 1 · standardAP
1995-02-01Labeling · Supplement 2 · standardAP
1992-04-17Type 3 - New Dosage Form · 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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