FDA.reportPublic FDA data

Application 204042

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVOKANACANAGLIFLOZINTABLET;ORAL100MGYesNo
002INVOKANACANAGLIFLOZINTABLET;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4364INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-4364INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-4364INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-4364INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5029INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5029INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5033INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5033INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5033INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5034INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5034INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5034INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50090-5034INVOKANAcanagliflozinA-S Medication SolutionsNDACurrent
50458-140INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-140INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-140INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-140INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-140INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-140INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-140INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-141INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-141INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-141INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-141INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-141INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-141INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
50458-141INVOKANAcanagliflozinJanssen Pharmaceuticals, Inc.NDACurrent
55154-1425INVOKANAcanagliflozinCardinal HealthNDACurrent
55154-1425INVOKANAcanagliflozinCardinal HealthNDACurrent
55154-1425INVOKANAcanagliflozin.Cardinal HealthNDACurrent
55154-1425INVOKANAcanagliflozin.Cardinal HealthNDACurrent
55154-1425INVOKANAcanagliflozinCardinal Health 107, LLCNDACurrent
55154-1425INVOKANAcanagliflozinCardinal HealthNDACurrent
55154-1425INVOKANAcanagliflozinCardinal HealthNDACurrent
55154-1426INVOKANAcanagliflozinCardinal HealthNDACurrent
55154-1426INVOKANAcanagliflozinCardinal HealthNDACurrent
55154-1426INVOKANAcanagliflozinCardinal Health 107, LLCNDACurrent
55154-1426INVOKANAcanagliflozin.Cardinal HealthNDACurrent
55154-1426INVOKANAcanagliflozin.Cardinal HealthNDACurrent
55154-1426INVOKANAcanagliflozinCardinal HealthNDACurrent
55154-1426INVOKANAcanagliflozinCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80653SUPPL 2024-12-19
80631SUPPL 2024-12-19
80630SUPPL 2024-12-19
79481SUPPL 2024-08-26
79480SUPPL 2024-08-26
79470SUPPL 2024-08-26
79469SUPPL 2024-08-26
74709SUPPL 2023-07-07
74697SUPPL 2023-07-06
72362SUPPL2022-10-17
72361SUPPL2022-10-17
72331SUPPL2022-10-14
68764SUPPL2021-09-24
64316SUPPL2020-08-19
64315SUPPL2020-08-19
64302SUPPL2020-08-19
62296SUPPL2020-03-24
61692SUPPL2020-01-27
61654SUPPL2020-01-27
61648SUPPL2020-01-27
60529SUPPL2019-10-10
60518SUPPL2019-10-10
60165SUPPL2019-09-30
60160SUPPL2019-09-30
56213SUPPL2018-10-31
56204SUPPL2018-10-31
56192SUPPL2018-10-30
56172SUPPL2018-10-30
52736SUPPL2018-02-27
49116SUPPL2017-07-28
49064SUPPL2017-07-25
47085SUPPL2017-02-01
47084SUPPL2017-02-01
45094SUPPL2016-08-22
45142SUPPL2016-08-17
32496SUPPL2016-05-24
10288SUPPL2016-05-24
40349SUPPL2016-05-23
19518SUPPL2016-05-23
40348SUPPL2016-03-30
32494SUPPL2016-03-30
32495SUPPL2015-12-08
19517SUPPL2015-12-08
19516SUPPL2015-09-11
40347SUPPL2015-03-05
10287SUPPL2015-03-04
10286SUPPL2014-05-20
40346SUPPL2014-05-19
43454ORIG2013-05-10
60772ORIG2013-04-01
40345ORIG2013-04-01
32493ORIG2013-04-01