Xarelto

NDA 202439, held by Janssen Pharms. Rivaroxaban.

As of Nov 14, 2026, NDA 202439 (Xarelto), held by Janssen Pharms, was first approved by FDA on Nov 4, 2011, with 25 approved supplements and 0 published complete response letters.

First approved: Nov 4, 2011
Review: Standard
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below


Aug 23, 2021	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 10, 2020	Supplement 31Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 11, 2018	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label
May 6, 2016	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 4, 2011	Original applicationNew indication · Standard review	Approved	Label Letter Review

Products

4 strengths and forms


Xarelto10MG · tablet;oral	Rivaroxaban	Rx
Xarelto15MG · tablet;oral	Rivaroxaban	Rx
Xarelto20MG · tablet;oral	Rivaroxaban	Rx
Xarelto2.5MG · tablet;oral	Rivaroxaban	Rx

All 26 submissions, including labeling and manufacturing supplements


Mar 1, 2022	Supplement 38Labeling · Standard review	Approved	Letter Label Medication Guide
Aug 23, 2021	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jan 28, 2021	Supplement 36Labeling · Standard review	Approved	Letter Label
Mar 10, 2020	Supplement 31Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 15, 2019	Supplement 34Labeling · Standard review	Approved	Label Letter
Oct 11, 2019	Supplement 33Labeling · Standard review	Approved	Letter Label
Aug 23, 2019	Supplement 32Labeling · Standard review	Approved	Label Letter
Feb 1, 2019	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 11, 2018	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label
Jul 27, 2018	Supplement 23Labeling · Standard review	Approved	Letter
Jun 27, 2018	Supplement 27Labeling · Standard review	Approved	Letter Label
Feb 8, 2018	Supplement 24Labeling · Standard review	Approved	Label Letter
Mar 29, 2017	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 5, 2016	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 6, 2016	Supplement 19Labeling · Standard review	Approved	Letter
May 6, 2016	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 10, 2015	Supplement 15Labeling · Standard review	Approved	Letter Label
Feb 16, 2015	Supplement 13Manufacturing	Approved	None posted
May 15, 2014	Supplement 11Manufacturing	Approved	None posted
Feb 12, 2014	Supplement 12REMS	Approved	Letter
Aug 7, 2013	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 3, 2013	Supplement 3Manufacturing	Approved	None posted
Nov 5, 2012	Supplement 7REMS	Approved	None posted
Jul 12, 2012	Supplement 5REMS	Approved	None posted
Dec 5, 2011	Supplement 1Labeling	Approved	None posted
Nov 4, 2011	Original applicationNew indication · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 202439
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters