APPLICATION
ANDA204345
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-04
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CAPECITABINEPrescription
CAPECITABINE 500MG · TABLET · ORAL
CAPECITABINEPrescription
CAPECITABINE 150MG · TABLET · ORAL
Approval history
2026-05-07Labeling · Supplement 5 · standardAP
2025-03-31Labeling · Supplement 3 · standardAP
2022-01-14Labeling · Supplement 1 · standardAP
2020-12-04UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.