Application 207947

Type: NDA
Sponsor: ACTELION PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UPTRAVI	SELEXIPAG	TABLET;ORAL	0.2MG	Yes	No
002	UPTRAVI	SELEXIPAG	TABLET;ORAL	0.4MG	Yes	Yes
003	UPTRAVI	SELEXIPAG	TABLET;ORAL	0.6MG	Yes	No
004	UPTRAVI	SELEXIPAG	TABLET;ORAL	0.8MG	Yes	No
005	UPTRAVI	SELEXIPAG	TABLET;ORAL	1MG	Yes	No
006	UPTRAVI	SELEXIPAG	TABLET;ORAL	1.2MG	Yes	No
007	UPTRAVI	SELEXIPAG	TABLET;ORAL	1.4MG	Yes	No
008	UPTRAVI	SELEXIPAG	TABLET;ORAL	1.6MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-616	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-616	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-616	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69121	SUPPL	2021-10-26
69114	SUPPL	2021-10-26
68447	SUPPL	2021-08-24
68426	SUPPL	2021-08-20
66048	SUPPL	2021-02-01
66041	SUPPL	2021-02-01
59920	SUPPL	2019-09-05
59914	SUPPL	2019-09-05
50906	SUPPL	2017-12-27
50845	SUPPL	2017-12-22
49895	SUPPL	2017-09-29
49881	SUPPL	2017-09-29
49078	SUPPL	2017-07-25
49054	SUPPL	2017-07-25
24529	ORIG	2016-01-28
23043	ORIG	2016-01-28
32866	ORIG	2015-12-22
19976	ORIG	2015-12-22

Application 207947

Related Records#

Application Products#

NDC Listings For This Application#

Documents#