Application 022406

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XARELTO	RIVAROXABAN	TABLET;ORAL	10MG	Yes	No
002	XARELTO	RIVAROXABAN	TABLET;ORAL	15MG	Yes	No
003	XARELTO	RIVAROXABAN	TABLET;ORAL	20MG	Yes	Yes
004	XARELTO	RIVAROXABAN	TABLET;ORAL	2.5MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3625	Xarelto	rivaroxaban	A-S Medication Solutions	NDA	Current
50090-3625	Xarelto	rivaroxaban	A-S Medication Solutions	NDA	Current
50090-4469	Xarelto	rivaroxaban	A-S Medication Solutions	NDA	Current
50090-4469	Xarelto	rivaroxaban	A-S Medication Solutions	NDA	Current
50458-577	XARELTO	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-577	XARELTO	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-578	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-578	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-579	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-579	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals,	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-580	Xarelto	rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals,	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-584	XARELTO	Rivaroxaban	Janssen Pharmaceuticals, Inc.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health 107, LLC	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health 107, LLC	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current
55154-1422	Xarelto	rivaroxaban	Cardinal Health.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85553	SUPPL	2026-03-27
85533	SUPPL	2026-03-26
85539	SUPPL	2026-03-24
82602	SUPPL	2025-06-20
82599	SUPPL	2025-06-20
82597	SUPPL	2025-06-18
73426	SUPPL	2023-02-09
73423	SUPPL	2023-02-09
70373	SUPPL	2022-03-02
70372	SUPPL	2022-03-02
70355	SUPPL	2022-03-02
68462	SUPPL	2021-08-25
68461	SUPPL	2021-08-25
68453	SUPPL	2021-08-25
66024	SUPPL	2021-01-29
66023	SUPPL	2021-01-29
66021	SUPPL	2021-01-29
62124	SUPPL	2020-03-11
62119	SUPPL	2020-03-11
62117	SUPPL	2020-03-11
61025	SUPPL	2019-11-22
61022	SUPPL	2019-11-22
60900	SUPPL	2019-11-19
60564	SUPPL	2019-10-15
60543	SUPPL	2019-10-11
59865	SUPPL	2019-08-28
59844	SUPPL	2019-08-27
57306	SUPPL	2019-01-22
57305	SUPPL	2019-01-22
57226	SUPPL	2019-01-17
57227	SUPPL	2019-01-16
56462	SUPPL	2018-11-15
56390	SUPPL	2018-11-08
55086	SUPPL	2018-08-03
55075	SUPPL	2018-08-02
50240	SUPPL	2017-10-31
50233	SUPPL	2017-10-30
48881	SUPPL	2017-06-30
48870	SUPPL	2017-06-29
45168	SUPPL	2016-08-25
45167	SUPPL	2016-08-25
45060	SUPPL	2016-08-25
45059	SUPPL	2016-08-25
45095	SUPPL	2016-08-22
45048	SUPPL	2016-08-17
17549	SUPPL	2015-01-20
7338	SUPPL	2015-01-20
17550	SUPPL	2015-01-09
7339	SUPPL	2014-12-24
38667	SUPPL	2014-09-19
17547	SUPPL	2014-03-07
7337	SUPPL	2014-03-07
29696	SUPPL	2014-02-14
17548	SUPPL	2014-02-14
17332	SUPPL	2014-01-10
29695	SUPPL	2014-01-09
22013	ORIG	2013-09-05
17331	SUPPL	2013-03-05
7336	SUPPL	2013-03-04
38666	SUPPL	2012-11-06
29694	SUPPL	2012-11-06
29693	SUPPL	2012-11-06
17330	SUPPL	2012-11-06
17329	SUPPL	2012-11-06
7335	SUPPL	2012-11-06
17328	ORIG	2011-07-07
7334	ORIG	2011-07-07

Application 022406

Related Records#

Application Products#

NDC Listings For This Application#

Documents#