APPLICATION
ANDA077537
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-18
LATEST ACTION
2015-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLYBURIDEDiscontinued
GLYBURIDE 1.25MG · TABLET · ORAL
GLYBURIDEDiscontinued
GLYBURIDE 2.5MG · TABLET · ORAL
GLYBURIDEDiscontinued
GLYBURIDE 5MG · TABLET · ORAL
Approval history
2015-10-06Labeling · Supplement 11 · standardAP
2015-02-25Labeling · Supplement 10 · standardAP
2012-09-28Labeling · Supplement 7AP
2009-03-20Labeling · Supplement 4AP
2008-12-31Labeling · Supplement 3AP
2007-10-18OriginalAP
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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