APPLICATION
ANDA078555
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-22
LATEST ACTION
2025-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
REPAGLINIDEPrescription
REPAGLINIDE 2MG · TABLET · ORAL
REPAGLINIDEPrescription
REPAGLINIDE 0.5MG · TABLET · ORAL
REPAGLINIDEPrescription
REPAGLINIDE 1MG · TABLET · ORAL
Approval history
2025-07-01Labeling · Supplement 8 · standardAP
2025-07-01Labeling · Supplement 9 · standardAP
2014-01-22OriginalAP
2013-11-22OriginalAP
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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