vortioxetine Oral Tablet

Brand(s)
Brintellix
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Takeda Pharmaceuticals America, Inc. (2014-07-28)
Oldest Current Product
2013-10-02
License(s)
NDA
RxNORM
ORAL TABLET\VORTIOXETINE
FDAOB
ORAL\TABLET\VORTIOXETINE HYDROBROMIDE
SPL Active
ORAL\TABLET, FILM COATED\VORTIOXETINE HYDROBROMIDE
SPL Moiety
ORAL\TABLET, FILM COATED\VORTIOXETINE

product(s) by strength(s)

vortioxetine 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640560BrintellixNDATakeda Pharmaceuticals America, Inc.2013-10-02VORTIOXETINE HYDROBROMIDEORALTABLET, FILM COATEDNDA2044474b0700c9-b417-4c3a-b36f-de461e125bd3

vortioxetine 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640570BrintellixNDATakeda Pharmaceuticals America, Inc.2013-10-02VORTIOXETINE HYDROBROMIDEORALTABLET, FILM COATEDNDA2044474b0700c9-b417-4c3a-b36f-de461e125bd3

vortioxetine 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640580BrintellixNDATakeda Pharmaceuticals America, Inc.2013-10-02VORTIOXETINE HYDROBROMIDEORALTABLET, FILM COATEDNDA2044474b0700c9-b417-4c3a-b36f-de461e125bd3

vortioxetine 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640550BrintellixNDATakeda Pharmaceuticals America, Inc.2013-10-02VORTIOXETINE HYDROBROMIDEORALTABLET, FILM COATEDNDA2044474b0700c9-b417-4c3a-b36f-de461e125bd3

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204447BRINTELLIXTAKEDA PHARMACEUTICALS USA INC2013-09-30p7144884, METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION, SUBSTANCE
p8476279, METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION, SUBSTANCE
p8722684, SUBSTANCE
p8969355, METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
NEW CHEMICAL ENTITY [2018-09-30]NDA204447_001, NDA204447_002, NDA204447_003, NDA204447_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204447_001RXVORTIOXETINE HYDROBROMIDE (EQ 5MG BASE)ORALTABLETFalse2013-09-30BRINTELLIX
2NDA204447_002RXVORTIOXETINE HYDROBROMIDE (EQ 10MG BASE)ORALTABLETFalse2013-09-30BRINTELLIX
3NDA204447_003RXVORTIOXETINE HYDROBROMIDE (EQ 15MG BASE)ORALTABLETFalse2013-09-30BRINTELLIX
4NDA204447_004RXVORTIOXETINE HYDROBROMIDE (EQ 20MG BASE)ORALTABLETTrue2013-09-30BRINTELLIX

patent(s)

#idexpiration dateapplication(s)
1p7144884 (view patent)2023-01-09NDA204447
2p8476279 (view patent)2022-10-02NDA204447
3p8722684 (view patent)2031-06-30NDA204447
4p8969355 (view patent)2027-06-15NDA204447

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
14b0700c9-b417-4c3a-b36f-de461e125bd3 (view SPL)These highlights do not include all the information needed to use BRINTELLIX safely and effectively. See full prescribing information for BRINTELLIX.BRINTELLIX (vortioxetine) tablets, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2014-07-285647640550, 647640560, 647640570, 647640580

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII