APPLICATION
ANDA077624
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-28
LATEST ACTION
2019-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLIMEPIRIDEDiscontinued
GLIMEPIRIDE 2MG · TABLET · ORAL
GLIMEPIRIDEDiscontinued
GLIMEPIRIDE 4MG · TABLET · ORAL
GLIMEPIRIDEDiscontinued
GLIMEPIRIDE 1MG · TABLET · ORAL
Approval history
2019-05-31Labeling · Supplement 7 · standardAP
2017-04-17Labeling · Supplement 6 · standardAP
2016-04-26Labeling · Supplement 5 · standardAP
2009-05-19Labeling · Supplement 3AP
2007-10-01Labeling · Supplement 1AP
2005-11-28OriginalAP
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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