APPLICATION
ANDA074591
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-22
LATEST ACTION
2021-03-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 6MG · TABLET · ORAL
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 3MG · TABLET · ORAL
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 4.5MG · TABLET · ORAL
GLYBURIDE (MICRONIZED)Discontinued
GLYBURIDE 1.5MG · TABLET · ORAL
Approval history
2021-03-23Labeling · Supplement 9 · standardAP
2021-03-23Labeling · Supplement 11 · standardAP
2015-02-18Labeling · Supplement 7 · standardAP
2001-08-27Manufacturing (CMC) · Supplement 1AP
1997-12-22OriginalAP
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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