NDA 022406

JANSSEN PHARMS

FDA Drug Application

Application #022406

Documents

• Letter: 2011-07-07
• Letter: 2012-11-06
• Letter: 2013-03-04
• Letter: 2014-03-07
• Letter: 2015-01-20
• Letter: 2014-12-24
• Label: 2011-07-07
• Label: 2012-11-06
• Label: 2012-11-06
• Label: 2013-03-05
• Label: 2014-01-10
• Label: 2014-03-07
• Label: 2014-02-14
• Label: 2015-01-20
• Label: 2015-01-09
• Review: 2013-09-05
• Letter: 2012-11-06
• Letter: 2012-11-06
• Letter: 2014-01-09
• Letter: 2014-02-14
• Label: 2012-11-06
• Label: 2014-09-19
• Letter: 2016-08-17
• Letter: 2016-08-25
• Letter: 2016-08-25
• Label: 2016-08-22
• Label: 2016-08-25
• Label: 2016-08-25
• Label: 2017-06-29
• Letter: 2017-06-30
• Label: 2017-10-30
• Letter: 2017-10-31
• Label: 2018-08-02
• Letter: 2018-08-03
• Label: 2018-11-08
• Letter: 2018-11-15
• Label: 2019-01-17
• Label: 2019-01-16
• Letter: 2019-01-22
• Letter: 2019-01-22
• Letter: 2019-08-27
• Label: 2019-08-28
• Label: 2019-10-11
• Letter: 2019-10-15
• Letter: 2019-11-19
• Label: 2019-11-22
• Medication Guide: 2019-11-22
• Letter: 2020-03-11
• Label: 2020-03-11
• Medication Guide: 2020-03-11
• Letter: 2021-01-29
• Label: 2021-01-29
• Medication Guide: 2021-01-29
• Letter: 2021-08-25
• Medication Guide: 2021-08-25
• Label: 2021-08-25
• Letter: 2022-03-02
• Label: 2022-03-02
• Medication Guide: 2022-03-02

Application Sponsors

NDA 022406

JANSSEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	10MG	1	XARELTO	RIVAROXABAN
002	TABLET;ORAL	15MG	1	XARELTO	RIVAROXABAN
003	TABLET;ORAL	20MG	1	XARELTO	RIVAROXABAN
004	TABLET;ORAL	2.5MG	1	XARELTO	RIVAROXABAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2011-07-01	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2012-11-02	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2012-11-02	PRIORITY
EFFICACY; Efficacy	SUPPL	4	AP	2013-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2013-01-31	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-01-07	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-03-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2014-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2014-09-15	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2015-05-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2014-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2015-10-26	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-08-17	STANDARD
LABELING; Labeling	SUPPL	19	AP	2016-08-25	STANDARD
LABELING; Labeling	SUPPL	20	AP	2016-08-25	STANDARD
LABELING; Labeling	SUPPL	21	AP	2017-02-10	STANDARD
LABELING; Labeling	SUPPL	23	AP	2017-06-28	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2017-10-27	PRIORITY
LABELING; Labeling	SUPPL	27	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	28	AP	2018-07-30	STANDARD
LABELING; Labeling	SUPPL	29	AP	2018-11-07	STANDARD
LABELING; Labeling	SUPPL	30	AP	2019-01-15	STANDARD
LABELING; Labeling	SUPPL	32	AP	2019-01-15	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	34	AP	2019-08-23	STANDARD
LABELING; Labeling	SUPPL	35	AP	2020-03-10	STANDARD
LABELING; Labeling	SUPPL	36	AP	2021-01-28	STANDARD
LABELING; Labeling	SUPPL	37	AP	2021-08-23	STANDARD
LABELING; Labeling	SUPPL	39	AP	2022-03-01	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	0
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	6
SUPPL	11	Null	0
SUPPL	12	Null	15
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	15
SUPPL	16	Null	0
SUPPL	17	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	23	Null	6
SUPPL	24	Null	6
SUPPL	27	Null	6
SUPPL	28	Null	6
SUPPL	29	Null	6
SUPPL	30	Null	7
SUPPL	32	Null	6
SUPPL	33	Null	7
SUPPL	34	Null	15
SUPPL	35	Null	6
SUPPL	36	Null	6
SUPPL	37	Null	6
SUPPL	39	Null	6

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22406
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/202439_S035_022406S037lbl.pdf#page=65"]
            [products] => [{"drugName":"XARELTO","activeIngredients":"RIVAROXABAN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XARELTO","activeIngredients":"RIVAROXABAN","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XARELTO","activeIngredients":"RIVAROXABAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"XARELTO","activeIngredients":"RIVAROXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/23\/2021","submission":"SUPPL-37","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202439_S035_022406S037lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2021","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202439_S035_022406S037lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2021","submission":"SUPPL-36","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022406s036,202439s036lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2021","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022406s036,202439s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2020","submission":"SUPPL-35","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202439s031,022406s035lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2020","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202439s031,022406s035lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s027,202439s034lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2019","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s033,202439s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2019","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s034,202439s032lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2019","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s030s032lbledt.pdf\"}]","notes":""},{"actionDate":"01\/15\/2019","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s030s032lbledt.pdf\"}]","notes":""},{"actionDate":"11\/07\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022406s029lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022406s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2017","submission":"SUPPL-24","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022406s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022406s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022406s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022406s019s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022406s019s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022406s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022406s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022406s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2014","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022406s011lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/06\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022406s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022406s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022406s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022406s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2013","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022406s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2012","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022406s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2012","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022406s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2012","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022406s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022406s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"XARELTO","submission":"RIVAROXABAN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XARELTO","submission":"RIVAROXABAN","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XARELTO","submission":"RIVAROXABAN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XARELTO","submission":"RIVAROXABAN","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-08-23
        )

)