FDA.reportPublic FDA data

Application 204447

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRINTELLIXVORTIOXETINE HYDROBROMIDETABLET;ORALEQ 5MG BASEYesNo
002TRINTELLIXVORTIOXETINE HYDROBROMIDETABLET;ORALEQ 10MG BASEYesNo
003TRINTELLIXVORTIOXETINE HYDROBROMIDETABLET;ORALEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004TRINTELLIXVORTIOXETINE HYDROBROMIDETABLET;ORALEQ 20MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal Health 107, LLCNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal HealthNDACurrent
55154-0256TrintellixvortioxetineCardinal Health 107, LLCNDACurrent
55154-0256TrintellixvortioxetineCardinal Health 107, LLCNDACurrent
55154-0257TrintellixvortioxetineCardinal Health 107, LLCNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal Health 107, LLCNDACurrent
55154-0257TrintellixvortioxetineCardinal Health 107, LLCNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
55154-0257TrintellixvortioxetineCardinal HealthNDACurrent
64764-550BrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-560BrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-570BrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-580BrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-720TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-720TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-720TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-720TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-720TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-720TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-730TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-730TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-730TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-730TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-730TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-730TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-750TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-750TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-750TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-750TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-750TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-750TrintellixvortioxetineTakeda Pharmaceuticals America, Inc.NDACurrent
70518-2642TrintellixvortioxetineREMEDYREPACK INC.NDACurrent
70518-2642TrintellixvortioxetineREMEDYREPACK INC.NDACurrent
70518-2642TrintellixvortioxetineREMEDYREPACK INC.NDACurrent
70518-2642TrintellixvortioxetineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75282SUPPL 2023-08-24
75281SUPPL 2023-08-24
75276SUPPL 2023-08-24
75233SUPPL 2023-08-22
75198SUPPL 2023-08-22
70730SUPPL2022-04-07
70729SUPPL2022-04-07
70728SUPPL2022-04-07
68823SUPPL2021-09-30
68822SUPPL2021-09-30
68735SUPPL2021-09-23
66015SUPPL2021-01-28
66010SUPPL2021-01-28
66009SUPPL2021-01-28
65989SUPPL2021-01-26
65988SUPPL2021-01-26
65233SUPPL2020-11-16
65224SUPPL2020-11-16
59450SUPPL2019-07-25
59449SUPPL2019-07-25
59437SUPPL2019-07-24
56082SUPPL2018-10-23
56048SUPPL2018-10-22
54014SUPPL2018-05-04
54002SUPPL2018-05-03
48034SUPPL2017-04-14
47988SUPPL2017-04-12
47872SUPPL2017-04-05
47850SUPPL2017-04-04
47556SUPPL2017-03-14
47533SUPPL2017-03-13
47278SUPPL2017-02-22
45560SUPPL2016-10-19
45219SUPPL2016-08-30
45183SUPPL2016-08-30
10345SUPPL2016-05-04
40393SUPPL2016-05-03
40392SUPPL2014-09-09
19564SUPPL2014-07-29
10344SUPPL2014-07-21
44902ORIG2013-10-30
43465ORIG2013-10-30
32563ORIG2013-10-02
19563ORIG2013-10-01