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FDA NDA · NDA202439

XARELTO

Sponsor: JANSSEN PHARMS

APPLICATION
NDA202439
TYPE
NDA
ORIGINAL APPROVAL
2011-11-04
LATEST ACTION
2022-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XARELTOPrescription
RIVAROXABAN 20MG · TABLET · ORAL
XARELTOPrescription
RIVAROXABAN 10MG · TABLET · ORAL
XARELTOPrescription
RIVAROXABAN 2.5MG · TABLET · ORAL
XARELTOPrescription
RIVAROXABAN 15MG · TABLET · ORAL

Approval history

2022-03-01Labeling · Supplement 38 · standard — Letter ↗AP
2021-08-23Efficacy · Supplement 35 · standard — Letter ↗AP
2021-01-28Labeling · Supplement 36 · standard — Letter ↗AP
2020-03-10Efficacy · Supplement 31 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 34 · standard — Letter ↗AP
2019-10-11Labeling · Supplement 33 · standard — Label ↗AP
2019-08-23Labeling · Supplement 32 · standard — Letter ↗AP
2019-02-01Labeling · Supplement 29 · standard — Label ↗AP
2018-10-11Efficacy · Supplement 25 · standard — Label ↗AP
2018-07-27Labeling · Supplement 23 · standard — Letter ↗AP
2018-06-27Labeling · Supplement 27 · standard — Label ↗AP
2018-02-08Labeling · Supplement 24 · standard — Label ↗AP
2017-03-29Labeling · Supplement 21 · standard — Label ↗AP
2016-10-05Labeling · Supplement 20 · standard — Letter ↗AP
2016-09-06Labeling · Supplement 19 · standard — Letter ↗AP
2016-05-06Efficacy · Supplement 17 · standard — Label ↗AP
2015-09-10Labeling · Supplement 15 · standard — Label ↗AP
2015-02-16Manufacturing (CMC) · Supplement 13AP
2014-05-15Manufacturing (CMC) · Supplement 11AP
2014-02-12REMS · Supplement 12 — Letter ↗AP
2013-08-07Labeling · Supplement 8 · standard — Letter ↗AP
2013-04-03Manufacturing (CMC) · Supplement 3AP
2012-11-05REMS · Supplement 7AP
2012-07-12REMS · Supplement 5AP
2011-12-05Labeling · Supplement 1 · unknownAP
2011-11-04Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Review ↗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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