JANSSEN PHARMS FDA Approval NDA 202439

NDA 202439

JANSSEN PHARMS

FDA Drug Application

Application #202439

Documents

Letter2013-08-08
Letter2015-09-14
Label2014-06-03
Label2013-08-09
Letter2014-06-03
Letter2014-02-13
Letter2016-05-09
Label2015-09-11
Label2016-05-09
Review2014-06-03
Letter2016-09-08
Letter2016-10-14
Label2017-02-22
Label2017-03-30
Letter2017-04-03
Label2018-02-09
Letter2018-02-09
Label2018-07-05
Letter2018-07-06
Letter2018-07-30
Label2018-10-11
Label2019-02-04
Letter2019-02-13
Letter2019-08-27
Label2019-08-28
Label2019-10-11
Letter2019-10-15
Letter2019-11-19
Label2019-11-22
Medication Guide2019-11-22
Letter2020-03-11
Medication Guide2020-03-11
Label2020-03-11
Letter2021-01-29
Label2021-01-29
Medication Guide2021-01-29
Letter2021-08-25
Label2021-08-25
Medication Guide2021-08-25
Review2022-02-04
Letter2022-03-02
Label2022-03-02
Medication Guide2022-03-02

Application Sponsors

NDA 202439JANSSEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL10MG0XARELTORIVAROXABAN
002TABLET;ORAL15MG0XARELTORIVAROXABAN
003TABLET;ORAL20MG0XARELTORIVAROXABAN
004TABLET;ORAL2.5MG0XARELTORIVAROXABAN

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not ConsolidatedORIG1AP2011-11-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2013-04-03
REMS; REMSSUPPL5AP2012-07-12N/A
REMS; REMSSUPPL7AP2012-11-05N/A
LABELING; LabelingSUPPL8AP2013-08-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2014-05-15
REMS; REMSSUPPL12AP2014-02-12N/A
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2015-02-16
LABELING; LabelingSUPPL15AP2015-09-10STANDARD
EFFICACY; EfficacySUPPL17AP2016-05-06STANDARD
LABELING; LabelingSUPPL19AP2016-09-06STANDARD
LABELING; LabelingSUPPL20AP2016-10-05STANDARD
LABELING; LabelingSUPPL21AP2017-03-29STANDARD
LABELING; LabelingSUPPL23AP2018-07-27STANDARD
LABELING; LabelingSUPPL24AP2018-02-08STANDARD
EFFICACY; EfficacySUPPL25AP2018-10-11STANDARD
LABELING; LabelingSUPPL27AP2018-06-27STANDARD
LABELING; LabelingSUPPL29AP2019-02-01STANDARD
EFFICACY; EfficacySUPPL31AP2020-03-10STANDARD
LABELING; LabelingSUPPL32AP2019-08-23STANDARD
LABELING; LabelingSUPPL33AP2019-10-11STANDARD
LABELING; LabelingSUPPL34AP2019-11-15STANDARD
EFFICACY; EfficacySUPPL35AP2021-08-23STANDARD
LABELING; LabelingSUPPL36AP2021-01-28STANDARD
LABELING; LabelingSUPPL38AP2022-03-01STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null0
SUPPL5Null7
SUPPL7Null7
SUPPL8Null15
SUPPL11Null0
SUPPL12Null15
SUPPL13Null0
SUPPL15Null7
SUPPL17Null7
SUPPL19Null7
SUPPL20Null7
SUPPL21Null7
SUPPL23Null7
SUPPL24Null15
SUPPL25Null6
SUPPL27Null15
SUPPL29Null7
SUPPL31Null7
SUPPL32Null15
SUPPL33Null6
SUPPL34Null6
SUPPL35Null6
SUPPL36Null15
SUPPL38Null6

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
        )

)
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