APPLICATION
ANDA204741
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-28
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAPECITABINEDiscontinued
CAPECITABINE 150MG · TABLET · ORAL
CAPECITABINEDiscontinued
CAPECITABINE 500MG · TABLET · ORAL
Approval history
2026-05-07Labeling · Supplement 13 · standardAP
2025-04-09Labeling · Supplement 2 · standardAP
2025-04-09Labeling · Supplement 9 · standardAP
2025-04-09Labeling · Supplement 11 · standardAP
2017-02-28UNKNOWN · Original · standardAP
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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