Application 202192

Type: NDA
Sponsor: INCYTE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JAKAFI	RUXOLITINIB PHOSPHATE	TABLET;ORAL	EQ 5MG BASE	Yes	No
002	JAKAFI	RUXOLITINIB PHOSPHATE	TABLET;ORAL	EQ 10MG BASE	Yes	No
003	JAKAFI	RUXOLITINIB PHOSPHATE	TABLET;ORAL	EQ 15MG BASE	Yes	No
004	JAKAFI	RUXOLITINIB PHOSPHATE	TABLET;ORAL	EQ 20MG BASE	Yes	No
005	JAKAFI	RUXOLITINIB PHOSPHATE	TABLET;ORAL	EQ 25MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50881-005	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-005	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-005	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-005	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-005	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-005	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-005	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-010	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-010	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-010	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-010	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-010	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-010	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-010	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-015	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-015	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-015	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-015	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-015	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-015	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-015	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-020	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-020	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-020	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-020	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-020	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-020	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-020	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-025	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-025	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-025	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-025	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-025	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-025	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current
50881-025	JAKAFI	ruxolitinib	Incyte Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84206	SUPPL	2025-11-19
84205	SUPPL	2025-11-19
83894	SUPPL	2025-10-23
73363	SUPPL	2023-02-02
73352	SUPPL	2023-02-01
72979	SUPPL	2022-12-21
72964	SUPPL	2022-12-21
82553	SUPPL	2021-09-30
68817	SUPPL	2021-09-30
68813	SUPPL	2021-09-30
68792	SUPPL	2021-09-28
61646	SUPPL	2020-01-24
61628	SUPPL	2020-01-23
58952	SUPPL	2019-06-04
58862	SUPPL	2019-05-24
56165	SUPPL	2018-10-30
56145	SUPPL	2018-10-29
50665	SUPPL	2017-12-12
50660	SUPPL	2017-12-12
50024	SUPPL	2017-10-12
50006	SUPPL	2017-10-11
19293	SUPPL	2016-03-15
9988	SUPPL	2016-03-14
40137	SUPPL	2014-12-16
32204	SUPPL	2014-12-16
32203	SUPPL	2014-12-05
19292	SUPPL	2014-12-04
32202	SUPPL	2014-07-28
19080	SUPPL	2014-07-28
9987	SUPPL	2013-11-27
40136	SUPPL	2013-11-26
19079	SUPPL	2013-06-18
9986	SUPPL	2013-06-13
9985	SUPPL	2012-06-25
40135	SUPPL	2012-06-22
44847	ORIG	2012-01-09
22877	ORIG	2012-01-09
19078	ORIG	2011-11-16
9984	ORIG	2011-11-16
63243	SUPPL	1900-01-01
63242	SUPPL	1900-01-01
63190	SUPPL	1900-01-01
63189	SUPPL	1900-01-01

Application 202192

Related Records#

Application Products#

NDC Listings For This Application#

Documents#