Application 204410

Type: NDA
Sponsor: ACTELION PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPSUMIT	MACITENTAN	TABLET;ORAL	10MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66215-501	OPSUMIT	macitentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-501	OPSUMIT	macitentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-501	OPSUMIT	macitentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-501	OPSUMIT	macitentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-501	OPSUMIT	macitentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-501	OPSUMIT	macitentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-501	OPSUMIT	macitentan	Actelion Pharmaceuticals US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81890	SUPPL	2025-04-08
81821	SUPPL	2025-04-03
81422	SUPPL	2025-03-04
81399	SUPPL	2025-03-03
81398	SUPPL	2025-03-03
80566	SUPPL	2024-12-13
78123	SUPPL	2024-04-12
76511	ORIG	2023-11-07
74404	SUPPL	2023-05-30
74391	SUPPL	2023-05-30
74188	SUPPL	2023-05-09
69123	SUPPL	2021-10-26
69122	SUPPL	2021-10-26
69113	SUPPL	2021-10-26
67620	SUPPL	2021-05-28
67613	SUPPL	2021-05-27
67612	SUPPL	2021-05-27
62524	SUPPL	2020-04-09
58425	SUPPL	2019-04-26
58409	SUPPL	2019-04-25
57581	SUPPL	2019-02-13
56135	SUPPL	2018-10-29
56134	SUPPL	2018-10-29
55969	SUPPL	2018-10-17
49549	SUPPL	2017-08-28
47673	SUPPL	2017-03-23
47635	SUPPL	2017-03-22
45635	SUPPL	2016-10-25
40387	SUPPL	2016-06-21
32555	SUPPL	2016-06-21
10339	SUPPL	2016-02-24
32554	SUPPL	2016-02-19
19555	SUPPL	2016-02-18
32552	SUPPL	2015-11-19
19554	SUPPL	2015-11-19
40386	SUPPL	2015-05-04
32553	SUPPL	2015-05-04
43462	ORIG	2013-11-18
24469	ORIG	2013-11-18
24123	ORIG	2013-11-01
40385	ORIG	2013-10-22
32551	ORIG	2013-10-22