APPLICATION
ANDA091220
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-29
LATEST ACTION
2020-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLIMEPIRIDEPrescription
GLIMEPIRIDE 8MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 4MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 2MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 6MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 3MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 1MG · TABLET · ORAL
Approval history
2020-09-15Labeling · Supplement 15 · standardAP
2020-04-07Labeling · Supplement 14 · standardAP
2017-08-25Labeling · Supplement 10 · standardAP
2014-12-03Labeling · Supplement 2 · standardAP
2014-12-03Manufacturing (CMC) · Supplement 3AP
2012-06-29OriginalAP
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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