Application 204819

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADEMPAS	RIOCIGUAT	TABLET;ORAL	0.5MG	Yes	No
002	ADEMPAS	RIOCIGUAT	TABLET;ORAL	1MG	Yes	No
003	ADEMPAS	RIOCIGUAT	TABLET;ORAL	1.5MG	Yes	No
004	ADEMPAS	RIOCIGUAT	TABLET;ORAL	2MG	Yes	No
005	ADEMPAS	RIOCIGUAT	TABLET;ORAL	2.5MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85869	SUPPL	2026-05-11
76283	ORIG	2023-11-03
68614	SUPPL	2021-09-14
68600	SUPPL	2021-09-13
68599	SUPPL	2021-09-13
65464	SUPPL	2020-12-02
61868	SUPPL	2020-02-12
56697	SUPPL	2018-12-10
51072	SUPPL	2018-01-17
51056	SUPPL	2018-01-17
47416	SUPPL	2017-03-02
47326	SUPPL	2017-02-24
47206	SUPPL	2017-02-15
46962	SUPPL	2017-01-24
46904	SUPPL	2017-01-19
45504	SUPPL	2016-10-06
10400	SUPPL	2015-12-07
10398	SUPPL	2014-06-12
40425	SUPPL	2014-05-12
10399	SUPPL	2014-05-08
44911	ORIG	2013-11-05
22966	ORIG	2013-11-05
40424	ORIG	2013-10-17
44594	ORIG	2013-10-15
32595	ORIG	2013-10-10

Application 204819

Related Records#

Application Products#

NDC Listings For This Application#

Documents#