APPLICATION
ANDA202759
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-29
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 8 · standardAP
2017-12-27Labeling · Supplement 6 · standardAP
2016-02-29Labeling · Supplement 4 · standardAP
2012-06-29UNKNOWN · OriginalAP
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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