APPLICATION
ANDA077295
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-06
LATEST ACTION
2015-04-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLIMEPIRIDEPrescription
GLIMEPIRIDE 4MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 1MG · TABLET · ORAL
GLIMEPIRIDEPrescription
GLIMEPIRIDE 2MG · TABLET · ORAL
Approval history
2015-04-24Labeling · Supplement 8 · standardAP
2015-04-24Labeling · Supplement 6 · standardAP
2010-10-25Labeling · Supplement 4AP
2010-06-23Labeling · Supplement 3AP
2009-06-11Labeling · Supplement 2AP
2007-12-26Labeling · Supplement 1AP
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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