APPLICATION
ANDA074792
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-26
LATEST ACTION
2019-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 6MG · TABLET · ORAL
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 1.5MG · TABLET · ORAL
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 3MG · TABLET · ORAL
Approval history
2019-10-30Labeling · Supplement 15 · standardAP
2015-10-02Labeling · Supplement 14 · standardAP
2015-02-18Labeling · Supplement 13 · standardAP
2012-09-28Labeling · Supplement 12AP
2009-05-19Labeling · Supplement 9AP
2001-09-25Labeling · Supplement 5AP
2000-03-24Labeling · Supplement 4AP
1999-08-17Manufacturing (CMC) · Supplement 3AP
1999-08-17Manufacturing (CMC) · Supplement 1AP
1999-08-17Labeling · Supplement 2AP
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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