FDA.reportPublic FDA data

Application 203469

Type
NDA
Sponsor
ARIAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ICLUSIGPONATINIB HYDROCHLORIDETABLET;ORALEQ 15MG BASEYesNo
002ICLUSIGPONATINIB HYDROCHLORIDETABLET;ORALEQ 45MG BASEYesYes
003ICLUSIGPONATINIB HYDROCHLORIDETABLET;ORALEQ 30MG BASEYesNo
004ICLUSIGPONATINIB HYDROCHLORIDETABLET;ORALEQ 10MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63020-533Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-533Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-534Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-535Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-536Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-536Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-536Iclusigponatinib hydrochlorideMillennium Pharmaceuticals, Inc.NDACurrent
63020-536Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
63020-536Iclusigponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
76189-533Iclusigponatinib hydrochlorideARIAD Pharmaceuticals, Inc.NDACurrent
76189-534Iclusigponatinib hydrochlorideARIAD Pharmaceuticals, Inc.NDACurrent
76189-535Iclusigponatinib hydrochlorideARIAD Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83754SUPPL 2025-10-15
83731SUPPL 2025-10-14
83730SUPPL 2025-10-14
77883SUPPL 2024-03-20
77863SUPPL 2024-03-19
70177SUPPL2022-02-16
70176SUPPL2022-02-16
70174SUPPL2022-02-16
65676SUPPL2020-12-22
65634SUPPL2020-12-21
65626SUPPL2020-12-18
63887SUPPL2020-07-14
63886SUPPL2020-07-14
63856SUPPL2020-07-13
63645SUPPL2020-06-19
63644SUPPL2020-06-19
63627SUPPL2020-06-19
61575SUPPL2020-01-14
61574SUPPL2020-01-14
61561SUPPL2020-01-14
56128SUPPL2018-10-29
56127SUPPL2018-10-26
56078SUPPL2018-10-23
54386SUPPL2018-05-31
50909SUPPL2017-12-27
50907SUPPL2017-12-27
50851SUPPL2017-12-26
50850SUPPL2017-12-26
46960SUPPL2017-01-24
46089SUPPL2016-12-08
45979SUPPL2016-12-01
45971SUPPL2016-11-30
45272SUPPL2016-09-08
45210SUPPL2016-08-31
45190SUPPL2016-08-31
32430SUPPL2016-06-06
19473SUPPL2016-06-06
40300SUPPL2015-12-08
32429SUPPL2015-12-03
40299SUPPL2014-07-28
32428SUPPL2014-07-28
43435SUPPL2014-07-07
22923SUPPL2014-07-07
44431ORIG2014-02-04
40298SUPPL2013-12-20
32427SUPPL2013-12-20
24114ORIG2013-12-20
19472SUPPL2013-12-20
10218SUPPL2013-12-20
44884ORIG2012-12-21
43434ORIG2012-12-21
32426ORIG2012-12-19
19471ORIG2012-12-14