Application 203469

Type: NDA
Sponsor: ARIAD

Related Records

Company: ARIAD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ICLUSIG	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 15MG BASE	Yes	No
002	ICLUSIG	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 45MG BASE	Yes	Yes
003	ICLUSIG	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 30MG BASE	Yes	No
004	ICLUSIG	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
76189-533	Iclusig	ponatinib hydrochloride	ARIAD Pharmaceuticals, Inc.	NDA	Current
76189-534	Iclusig	ponatinib hydrochloride	ARIAD Pharmaceuticals, Inc.	NDA	Current
76189-535	Iclusig	ponatinib hydrochloride	ARIAD Pharmaceuticals, Inc.	NDA	Current

Documents

Document	Title	Submission type	Submission no.	Date
83754	0	SUPPL	38	2025-10-15
83731	0	SUPPL	38	2025-10-14
83730	0	SUPPL	38	2025-10-14
77883	0	SUPPL	37	2024-03-20
77863	0	SUPPL	37	2024-03-19
70177	0	SUPPL	35	2022-02-16
70176	0	SUPPL	35	2022-02-16
70174	0	SUPPL	35	2022-02-16
65676	0	SUPPL	34	2020-12-22
65634	0	SUPPL	34	2020-12-21
65626	0	SUPPL	34	2020-12-18
63887	0	SUPPL	33	2020-07-14
63886	0	SUPPL	33	2020-07-14
63856	0	SUPPL	33	2020-07-13
63645	0	SUPPL	32	2020-06-19
63644	0	SUPPL	32	2020-06-19
63627	0	SUPPL	32	2020-06-19
61575	0	SUPPL	31	2020-01-14
61574	0	SUPPL	31	2020-01-14
61561	0	SUPPL	31	2020-01-14
56128	0	SUPPL	30	2018-10-29
56127	0	SUPPL	30	2018-10-26
56078	0	SUPPL	30	2018-10-23
54386	0	SUPPL	29	2018-05-31
50909	0	SUPPL	27	2017-12-27
50907	0	SUPPL	28	2017-12-27
50851	0	SUPPL	28	2017-12-26
50850	0	SUPPL	27	2017-12-26
46960	0	SUPPL	24	2017-01-24
46089	0	SUPPL	22	2016-12-08
45979	0	SUPPL	22	2016-12-01
45971	0	SUPPL	22	2016-11-30
45272	0	SUPPL	24	2016-09-08
45210	0	SUPPL	23	2016-08-31
45190	0	SUPPL	23	2016-08-31
32430	0	SUPPL	21	2016-06-06
19473	0	SUPPL	21	2016-06-06
40300	0	SUPPL	20	2015-12-08
32429	0	SUPPL	20	2015-12-03
40299	0	SUPPL	9	2014-07-28
32428	0	SUPPL	9	2014-07-28
43435	0	SUPPL	7	2014-07-07
22923	0	SUPPL	8	2014-07-07
44431	0	ORIG	1	2014-02-04
40298	0	SUPPL	8	2013-12-20
32427	0	SUPPL	7	2013-12-20
24114	REMS	ORIG	1	2013-12-20
19472	0	SUPPL	7	2013-12-20
10218	0	SUPPL	8	2013-12-20
44884	0	ORIG	1	2012-12-21
43434	0	ORIG	1	2012-12-21
32426	0	ORIG	1	2012-12-19
19471	0	ORIG	1	2012-12-14