APPLICATION
ANDA090943
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-08
LATEST ACTION
2024-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CAPECITABINEPrescription
CAPECITABINE 150MG · TABLET · ORAL
CAPECITABINEPrescription
CAPECITABINE 500MG · TABLET · ORAL
Approval history
2024-10-10Labeling · Supplement 15 · standardAP
2022-09-23Labeling · Supplement 13 · standardAP
2019-12-17Labeling · Supplement 12 · standardAP
2019-12-17Labeling · Supplement 7 · standardAP
2019-12-17Labeling · Supplement 5 · standardAP
2016-02-18Labeling · Supplement 3 · standardAP
2014-08-08OriginalAP
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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