APPLICATION
ANDA077370
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-23
LATEST ACTION
2025-05-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLIMEPIRIDEPrescription
GLIMEPIRIDE 8MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 2MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 4MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 1MG · TABLET · ORAL
Approval history
2025-05-06Labeling · Supplement 13 · standardAP
2015-10-27Labeling · Supplement 9 · standardAP
2015-10-27Labeling · Supplement 10 · standardAP
2012-05-31Labeling · Supplement 4AP
2008-04-28Labeling · Supplement 2AP
2005-12-23OriginalAP
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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