FDA.reportPublic FDA data

Application 205422

Type
NDA
Sponsor
OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REXULTIBREXPIPRAZOLETABLET;ORAL0.25MGYesNo
002REXULTIBREXPIPRAZOLETABLET;ORAL0.5MGYesNo
003REXULTIBREXPIPRAZOLETABLET;ORAL1MGYesNo
004REXULTIBREXPIPRAZOLETABLET;ORAL2MGYesYes
005REXULTIBREXPIPRAZOLETABLET;ORAL3MGYesNo
006REXULTIBREXPIPRAZOLETABLET;ORAL4MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59148-035RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-035RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-036REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-037RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-038REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-039RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040REXULTIbrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
59148-040RexultibrexpiprazoleOtsuka America Pharmaceutical, Inc.NDACurrent
70518-3548RexultibrexpiprazoleREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85830SUPPL 2026-05-05
85829SUPPL 2026-05-05
85815SUPPL 2026-05-04
82192SUPPL 2025-05-15
82207SUPPL 2025-05-09
80568SUPPL 2024-12-13
80559SUPPL 2024-12-13
78441SUPPL 2024-05-08
78424SUPPL 2024-05-08
78423SUPPL 2024-05-08
75554SUPPL 2023-09-25
74217SUPPL 2023-05-11
74213SUPPL 2023-05-11
72283SUPPL2022-10-11
72274SUPPL2022-10-07
69796SUPPL2021-12-29
69792SUPPL2021-12-28
63642SUPPL2020-06-19
63641SUPPL2020-06-19
63626SUPPL2020-06-19
59103ORIG2019-06-17
59102ORIG2019-06-17
59101ORIG2019-06-17
52636SUPPL2018-02-14
52558SUPPL2018-02-12
52557SUPPL2018-02-12
47404SUPPL2017-03-02
47307SUPPL2017-02-24
45419SUPPL2016-09-29
45396SUPPL2016-09-26
43488ORIG2015-08-19
40466ORIG2015-07-13
10445ORIG2015-07-13