APPLICATION
ANDA200483
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-14
LATEST ACTION
2023-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAPECITABINEDiscontinued
CAPECITABINE 150MG · TABLET · ORAL
CAPECITABINEDiscontinued
CAPECITABINE 500MG · TABLET · ORAL
Approval history
2023-06-08Labeling · Supplement 8 · standardAP
2022-08-12Labeling · Supplement 7 · standardAP
2021-10-15Labeling · Supplement 6 · standardAP
2019-12-11Labeling · Supplement 5 · standardAP
2019-12-11Labeling · Supplement 2 · standardAP
2016-07-14Not Applicable · 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.
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