APPLICATION
ANDA202593
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-23
LATEST ACTION
2026-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CAPECITABINEPrescription
CAPECITABINE 150MG · TABLET · ORAL
CAPECITABINEPrescription
CAPECITABINE 500MG · TABLET · ORAL
Approval history
2026-06-09Labeling · Supplement 12 · standardAP
2026-06-09Labeling · Supplement 10 · standardAP
2026-06-09Labeling · Supplement 17 · standardAP
2026-06-09Labeling · Supplement 11 · standardAP
2026-06-09Labeling · Supplement 6 · standardAP
2026-06-09Labeling · Supplement 2 · standardAP
2016-04-04Manufacturing (CMC) · Supplement 1 · unknownAP
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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