APPLICATION
ANDA210203
TYPE
ANDA
ORIGINAL APPROVAL
2024-03-05
LATEST ACTION
2026-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CAPECITABINEPrescription
CAPECITABINE 150MG · TABLET · ORAL
CAPECITABINEPrescription
CAPECITABINE 500MG · TABLET · ORAL
Approval history
2026-07-01Labeling · Supplement 7 · standardAP
2024-03-05UNKNOWN · 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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