APPLICATION
ANDA078181
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-23
LATEST ACTION
2019-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLIMEPIRIDEPrescription
GLIMEPIRIDE 1MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 2MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 4MG · TABLET · ORAL
Approval history
2019-05-31Labeling · Supplement 14 · standardAP
2017-08-25Labeling · Supplement 11 · standardAP
2014-11-03Labeling · Supplement 7 · standardAP
2014-08-01Labeling · Supplement 6 · standardAP
2012-06-01Labeling · Supplement 5AP
2009-12-30Labeling · Supplement 2AP
2009-12-30Labeling · Supplement 3AP
2007-08-23OriginalAP
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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