Application 205552

Type: NDA
Sponsor: PHARMACYCLICS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMBRUVICA	IBRUTINIB	CAPSULE;ORAL	140MG	Yes	Yes
002	IMBRUVICA	IBRUTINIB	CAPSULE;ORAL	70MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57962-007	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-007	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83880	SUPPL	2025-10-23
83869	SUPPL	2025-10-22
80730	SUPPL	2024-12-26
80726	SUPPL	2024-12-26
78462	SUPPL	2024-05-14
78449	SUPPL	2024-05-10
78448	SUPPL	2024-05-10
78447	SUPPL	2024-05-10
74333	SUPPL	2023-05-22
74320	SUPPL	2023-05-19
71966	SUPPL	2022-08-30
71892	SUPPL	2022-08-25
71056	SUPPL	2022-05-12
71051	SUPPL	2022-05-12
69651	SUPPL	2021-12-20
65750	SUPPL	2020-12-28
65721	SUPPL	2020-12-28
65689	SUPPL	2020-12-22
65677	SUPPL	2020-12-22
64258	SUPPL	2020-08-11
64242	SUPPL	2020-08-10
62626	SUPPL	2020-04-22
62621	SUPPL	2020-04-21
62201	SUPPL	2020-03-19
61036	SUPPL	2019-11-22
61028	SUPPL	2019-11-22
59630	SUPPL	2019-08-08
59347	SUPPL	2019-07-16
57572	SUPPL	2019-02-13
57372	SUPPL	2019-01-29
55348	SUPPL	2018-08-28
55341	SUPPL	2018-08-28
55340	SUPPL	2018-08-28
55338	SUPPL	2018-08-28
54290	SUPPL	2018-05-22
50905	SUPPL	2017-12-27
50854	SUPPL	2017-12-26
50617	SUPPL	2017-12-06
43491	ORIG	2017-12-06
49244	SUPPL	2017-08-04
49200	SUPPL	2017-08-02
47884	SUPPL	2017-04-07
46946	SUPPL	2017-01-24
19657	SUPPL	2016-07-18
32687	SUPPL	2016-06-29
40481	SUPPL	2016-05-09
40480	SUPPL	2016-05-09
10465	SUPPL	2016-05-09
40479	SUPPL	2016-03-08
32686	SUPPL	2016-03-08
45441	ORIG	2015-04-13
45440	ORIG	2015-04-13
40478	SUPPL	2015-01-29
32685	SUPPL	2015-01-29
40477	SUPPL	2014-07-29
10464	SUPPL	2014-07-29
45439	ORIG	2014-02-14
45438	ORIG	2014-02-12
44921	ORIG	2013-11-25
40475	ORIG	2013-11-15
10462	ORIG	2013-11-15

Application 205552

Related Records#

Application Products#

NDC Listings For This Application#

Documents#