Documents
Application Sponsors
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
)
)