FDA.reportPublic FDA data

Application 022063

Type
NDA
Sponsor
SHIRE DEV LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYDAYISAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL3.125MG;3.125MG;3.125MG;3.125MGYesNo
002MYDAYISAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL6.25MG;6.25MG;6.25MG;6.25MGYesNo
003MYDAYISAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL9.375MG;9.375MG;9.375MG;9.375MGYesNo
004MYDAYISAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL12.5MG;12.5MG;12.5MG;12.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54092-468MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-468MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-468MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-468MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-468MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-468MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-471MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-471MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-471MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-471MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-471MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-471MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-474MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-474MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-474MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-474MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-474MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-474MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-477MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-477MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-477MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-477MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.NDACurrent
54092-477MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent
54092-477MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATEShire US Manufacturing Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85757SUPPL 2026-04-27
85804SUPPL 2026-04-24
85747SUPPL 2026-04-24
75776SUPPL 2023-10-16
75737SUPPL 2023-10-16
75736SUPPL 2023-10-16
70343SUPPL2022-03-01
70342SUPPL2022-03-01
70301SUPPL2022-02-28
63177ORIG2020-05-20
60505SUPPL2019-10-09
60363SUPPL2019-10-08
60015SUPPL2019-09-17
54466ORIG2018-06-06
48795ORIG2017-06-22
48788ORIG2017-06-21
63852ORIG1900-01-01
63851ORIG1900-01-01
63850ORIG1900-01-01
51379ORIG1900-01-01
51378ORIG1900-01-01
51377ORIG1900-01-01