Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET;ORAL | 10MG | 0 | XARELTO | RIVAROXABAN |
002 | TABLET;ORAL | 15MG | 0 | XARELTO | RIVAROXABAN |
003 | TABLET;ORAL | 20MG | 0 | XARELTO | RIVAROXABAN |
004 | TABLET;ORAL | 2.5MG | 0 | XARELTO | RIVAROXABAN |
FDA Submissions
TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated | ORIG | 1 | AP | 2011-11-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2013-04-03 | |
REMS; REMS | SUPPL | 5 | AP | 2012-07-12 | N/A |
REMS; REMS | SUPPL | 7 | AP | 2012-11-05 | N/A |
LABELING; Labeling | SUPPL | 8 | AP | 2013-08-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2014-05-15 | |
REMS; REMS | SUPPL | 12 | AP | 2014-02-12 | N/A |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2015-02-16 | |
LABELING; Labeling | SUPPL | 15 | AP | 2015-09-10 | STANDARD |
EFFICACY; Efficacy | SUPPL | 17 | AP | 2016-05-06 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2016-09-06 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2016-10-05 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2017-03-29 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2018-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2018-02-08 | STANDARD |
EFFICACY; Efficacy | SUPPL | 25 | AP | 2018-10-11 | STANDARD |
LABELING; Labeling | SUPPL | 27 | AP | 2018-06-27 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2019-02-01 | STANDARD |
EFFICACY; Efficacy | SUPPL | 31 | AP | 2020-03-10 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2019-08-23 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2019-10-11 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2019-11-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 35 | AP | 2021-08-23 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2021-01-28 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2022-03-01 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 8 | Null | 15 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 15 |
SUPPL | 13 | Null | 0 |
SUPPL | 15 | Null | 7 |
SUPPL | 17 | Null | 7 |
SUPPL | 19 | Null | 7 |
SUPPL | 20 | Null | 7 |
SUPPL | 21 | Null | 7 |
SUPPL | 23 | Null | 7 |
SUPPL | 24 | Null | 15 |
SUPPL | 25 | Null | 6 |
SUPPL | 27 | Null | 15 |
SUPPL | 29 | Null | 7 |
SUPPL | 31 | Null | 7 |
SUPPL | 32 | Null | 15 |
SUPPL | 33 | Null | 6 |
SUPPL | 34 | Null | 6 |
SUPPL | 35 | Null | 6 |
SUPPL | 36 | Null | 15 |
SUPPL | 38 | Null | 6 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 202439
[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":"No","rs":"No"},{"drugName":"XARELTO","activeIngredients":"RIVAROXABAN","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"XARELTO","activeIngredients":"RIVAROXABAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"XARELTO","activeIngredients":"RIVAROXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/23\/2021","submission":"SUPPL-35","supplementCategories":"Efficacy-New Indication","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-Package Insert","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-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022406s036,202439s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2020","submission":"SUPPL-31","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202439s031,022406s035lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-34","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":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s033,202439s033lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s033,202439s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2019","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s034,202439s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2019","submission":"SUPPL-32","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s034,202439s032lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202439s029lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202439s029lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2018","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202439s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202439s027lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202439s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202439s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202439s020lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202439s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2016","submission":"SUPPL-17","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202439s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202439s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202439s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202439s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/04\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202439s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202439s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202439toc.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/28\/2021","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022406s036,202439s036lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/022406Orig1s036,202439Orig1s036ltr.pdf\"}]","notes":">"},{"actionDate":"08\/23\/2021","submission":"SUPPL-35","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202439_S035_022406S037lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/022406Orig1s037;%20202439Orig1s035ltr.pdf\"}]","notes":">"},{"actionDate":"11\/15\/2019","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s027,202439s034lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"10\/11\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s033,202439s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/23\/2019","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022406s034,202439s032lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/10\/2020","submission":"SUPPL-31","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202439s031,022406s035lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/202439Orig1s031,022406Orig1s035ltr.pdf\"}]","notes":">"},{"actionDate":"02\/01\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202439s029lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/202439Orig1s029ltr.pdf\"}]","notes":">"},{"actionDate":"06\/27\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202439s027lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202439Orig1s027ltr.pdf\"}]","notes":">"},{"actionDate":"10\/11\/2018","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202439s025lbl.pdf\"}]","notes":">"},{"actionDate":"02\/08\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202439s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202439Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"07\/27\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202439Orig1s023Ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/29\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202439s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202439Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"10\/05\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202439s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202439Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"09\/06\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202439Orig1s019ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/06\/2016","submission":"SUPPL-17","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202439s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202439Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"09\/10\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202439s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202439Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"02\/16\/2015","submission":"SUPPL-13","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2014","submission":"SUPPL-12","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202439Orig1s012ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/15\/2014","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/07\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202439s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202439Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"11\/05\/2012","submission":"SUPPL-7","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/12\/2012","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/03\/2013","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/05\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-08-23
)
)