RecallHawk

XARELTO (RIVAROXABAN)

JANSSEN PHARMS

Summary

FDA approved XARELTO (RIVAROXABAN) by JANSSEN PHARMS. NDA (New Drug) approval (Labeling) on 2026-03-24. TABLET, ORAL.

Details

Source

Drug Approval

External ID

NDA022406-45

Action Date

2026-03-24

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

XARELTO (generic: RIVAROXABAN), TABLET, ORAL. Application: NDA022406

Context & Analysis

JANSSEN PHARMS has 10 FDA actions in our database.

Frequently Asked Questions

How often does JANSSEN PHARMS have FDA actions?

JANSSEN PHARMS has 10 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA022406-45" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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