← FDA DRUG APPROVALS

FDA NDA · NDA020896

XELODA

capecitabine

Sponsor: CHEPLAPHARM

APPLICATION
NDA020896
TYPE
NDA
ORIGINAL APPROVAL
1998-04-30
LATEST ACTION
2025-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

XELODA · ReferenceDiscontinued
CAPECITABINE 150MG · TABLET · ORAL
XELODA · ReferenceDiscontinued
CAPECITABINE 500MG · TABLET · ORAL

Approval history

2025-10-03Labeling · Supplement 52 · standard — Letter ↗AP
2022-12-14Efficacy · Supplement 49 · standard — Label ↗AP
2022-12-14Efficacy · Supplement 47 · standard — Label ↗AP
2022-12-14Efficacy · Supplement 45 · standard — Label ↗AP
2022-12-14Efficacy · Supplement 51 · standard — Label ↗AP
2022-12-14Efficacy · Supplement 48 · standard — Label ↗AP
2022-12-14Efficacy · Supplement 46 · standard — Label ↗AP
2022-12-14Efficacy · Supplement 44 · standard — Label ↗AP
2022-12-14Efficacy · Supplement 50 · standard — Label ↗AP
2021-05-19Labeling · Supplement 43 · standard — Letter ↗AP
2019-02-22Labeling · Supplement 42 · standard — Letter ↗AP
2016-12-14Labeling · Supplement 39 · standard — Letter ↗AP
2015-12-22Manufacturing (CMC) · Supplement 38 · priorityAP
2015-03-20Labeling · Supplement 37 · standard — Letter ↗AP
2015-03-02Labeling · Supplement 36 · standard — Label ↗AP
2015-01-05Manufacturing (CMC) · Supplement 35 · priorityAP
2014-10-16Labeling · Supplement 34 · standard — Label ↗AP
2014-07-22Manufacturing (CMC) · Supplement 33 · priorityAP
2013-12-10Efficacy · Supplement 32 · priority — Letter ↗AP
2011-02-05Efficacy · Supplement 26 · unknown — Letter ↗AP
2005-06-15Efficacy · Supplement 16 · unknown — Letter ↗AP
2003-03-15Labeling · Supplement 12 · standard — Label ↗AP
2001-09-07Efficacy · Supplement 10 · priority — Label ↗AP
2001-09-07Labeling · Supplement 11 · standard — Letter ↗AP
2001-04-30Efficacy · Supplement 6 · standard — Review ↗AP
2001-04-30Labeling · Supplement 9 · standard — Letter ↗AP
2000-03-24Labeling · Supplement 7 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 5 · priorityAP
1999-04-02Labeling · Supplement 4 · standardAP
1999-02-04Manufacturing (CMC) · Supplement 2 · priorityAP
1999-02-04Manufacturing (CMC) · Supplement 3 · priorityAP
1999-02-04Manufacturing (CMC) · Supplement 1 · priorityAP
1998-04-30Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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