APPLICATION
ANDA207652
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-27
LATEST ACTION
2026-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CAPECITABINEPrescription
CAPECITABINE 150MG · TABLET · ORAL
CAPECITABINEPrescription
CAPECITABINE 500MG · TABLET · ORAL
Approval history
2026-01-27Labeling · Supplement 13 · standardAP
2019-10-09Labeling · Supplement 3 · standardAP
2017-11-27UNKNOWN · 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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