FDA.reportPublic FDA data

Application 202439

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XARELTORIVAROXABANTABLET;ORAL10MGNoNo
002XARELTORIVAROXABANTABLET;ORAL15MGNoNo
003XARELTORIVAROXABANTABLET;ORAL20MGNoNo
004XARELTORIVAROXABANTABLET;ORAL2.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3639XareltorivaroxabanA-S Medication SolutionsNDACurrent
50090-4468XareltorivaroxabanA-S Medication SolutionsNDACurrent
50090-4468XareltorivaroxabanA-S Medication SolutionsNDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health 107, LLCNDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health 107, LLCNDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health 107, LLCNDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health 107, LLCNDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70375SUPPL2022-03-02
70374SUPPL2022-03-02
70356SUPPL2022-03-02
70093SUPPL2022-02-04
68460SUPPL2021-08-25
68459SUPPL2021-08-25
68454SUPPL2021-08-25
66026SUPPL2021-01-29
66025SUPPL2021-01-29
66022SUPPL2021-01-29
62123SUPPL2020-03-11
62122SUPPL2020-03-11
62116SUPPL2020-03-11
61024SUPPL2019-11-22
61023SUPPL2019-11-22
60902SUPPL2019-11-19
60565SUPPL2019-10-15
60544SUPPL2019-10-11
59866SUPPL2019-08-28
59845SUPPL2019-08-27
57534SUPPL2019-02-13
57412SUPPL2019-02-04
55878SUPPL2018-10-11
55047SUPPL2018-07-30
54835SUPPL2018-07-06
54763SUPPL2018-07-05
52546SUPPL2018-02-09
52527SUPPL2018-02-09
47841SUPPL2017-04-03
47786SUPPL2017-03-30
47281SUPPL2017-02-22
45541SUPPL2016-10-14
45273SUPPL2016-09-08
40185SUPPL2016-05-09
32262SUPPL2016-05-09
10050SUPPL2015-09-14
40184SUPPL2015-09-11
43402ORIG2014-06-03
32260ORIG2014-06-03
19348ORIG2014-06-03
32261SUPPL2014-02-13
19349SUPPL2013-08-09
10049SUPPL2013-08-08