← FDA DRUG APPROVALS

FDA NDA · NDA215859

XARELTO

rivaroxaban

Sponsor: JANSSEN PHARMS

APPLICATION
NDA215859
TYPE
NDA
ORIGINAL APPROVAL
2021-12-20
LATEST ACTION
2026-03-24
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

XARELTO · ReferencePrescription
RIVAROXABAN 1MG/ML · FOR SUSPENSION · ORAL

Approval history

2026-03-24Labeling · Supplement 7 · standard — Label ↗AP
2025-06-17Labeling · Supplement 5 · standard — Letter ↗AP
2023-02-08Labeling · Supplement 2 · standard — Letter ↗AP
2021-12-20Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →