← FDA DRUG APPROVALS

FDA NDA · NDA022406

XARELTO

rivaroxaban

Sponsor: JANSSEN PHARMS

APPLICATION
NDA022406
TYPE
NDA
ORIGINAL APPROVAL
2011-07-01
LATEST ACTION
2026-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XARELTO · ReferencePrescription
RIVAROXABAN 20MG · TABLET · ORAL
XARELTO · ReferencePrescription
RIVAROXABAN 10MG · TABLET · ORAL
XARELTO · ReferencePrescription
RIVAROXABAN 2.5MG · TABLET · ORAL
XARELTO · ReferencePrescription
RIVAROXABAN 15MG · TABLET · ORAL

Approval history

2026-03-24Labeling · Supplement 45 · standardLabelAP
2025-06-17Labeling · Supplement 44 · standardLetterAP
2023-02-08Labeling · Supplement 41 · standardLetterAP
2022-03-01Labeling · Supplement 39 · standardLetterAP
2021-08-23Labeling · Supplement 37 · standardLetterAP
2021-01-28Labeling · Supplement 36 · standardLetterAP
2020-03-10Labeling · Supplement 35 · standardLetterAP
2019-11-15Labeling · Supplement 27 · standardLetterAP
2019-10-11Efficacy · Supplement 33 · standardLabelAP
2019-08-23Labeling · Supplement 34 · standardLetterAP
2019-01-15Labeling · Supplement 30 · standardLabelAP
2019-01-15Labeling · Supplement 32 · standardLabelAP
2018-11-07Labeling · Supplement 29 · standardLabelAP
2018-07-30Labeling · Supplement 28 · standardLabelAP
2017-10-27Efficacy · Supplement 24 · priorityLabelAP
2017-06-28Labeling · Supplement 23 · standardLabelAP
2017-02-10Labeling · Supplement 21 · standardAP
2016-08-25Labeling · Supplement 20 · standardLetterAP
2016-08-25Labeling · Supplement 19 · standardLetterAP
2016-08-17Labeling · Supplement 17 · standardLetterAP
2015-10-26Manufacturing (CMC) · Supplement 16 · standardAP
2015-05-05Manufacturing (CMC) · Supplement 14 · standardAP
2015-02-16Manufacturing (CMC) · Supplement 13 · standardAP
2015-01-15Labeling · Supplement 12 · standardLetterAP
2014-12-19Labeling · Supplement 15 · standardLetterAP
2014-09-15Manufacturing (CMC) · Supplement 11 · standardLabelAP
2014-03-06Labeling · Supplement 9 · standardLetterAP
2014-02-13Labeling · Supplement 10 · standardLabelAP
2014-01-07Labeling · Supplement 7 · standardLabelAP
2013-03-01Efficacy · Supplement 4 · standardLetterAP
2013-01-31Manufacturing (CMC) · Supplement 6 · standardAP
2012-11-02Efficacy · Supplement 3 · priorityLabelAP
2012-11-02Efficacy · Supplement 1 · priorityLabelAP
2012-11-02Efficacy · Supplement 2 · priorityLetterAP
2011-07-01Type 1 - New Molecular Entity · Original · standardLetterAP
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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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