Application 021425

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	INJECTABLE;INJECTION	62.3%	Yes	Yes
002	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	INJECTABLE;INJECTION	76.9%	Yes	Yes
003	ULTRAVIST (PHARMACY BULK)	IOPROMIDE	INJECTABLE;INJECTION	49.9%	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-342	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-342	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-342	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-342	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-344	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-346	Ultravist	iopromide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74559	SUPPL	2023-06-21
74557	SUPPL	2023-06-20
74388	SUPPL	2023-05-26
74376	SUPPL	2023-05-26
74078	SUPPL	2023-04-27
74065	SUPPL	2023-04-26
70255	SUPPL	2022-02-25
70216	SUPPL	2022-02-22
59564	SUPPL	2019-08-02
59549	SUPPL	2019-08-02
54078	SUPPL	2018-05-10
53602	SUPPL	2018-04-05
53601	SUPPL	2018-04-04
47959	SUPPL	2017-04-12
47886	SUPPL	2017-04-07
5321	SUPPL	2015-07-10
36874	SUPPL	2015-07-09
15422	SUPPL	2012-05-07
36873	SUPPL	2010-07-01
5320	SUPPL	2010-06-29
27727	SUPPL	2010-01-20
5319	SUPPL	2007-09-06
15421	SUPPL	2007-09-04
5317	SUPPL	2004-06-29
36872	SUPPL	2004-04-05
5318	SUPPL	2004-03-16
21645	ORIG	2003-06-26
15420	ORIG	2002-09-20
5316	ORIG	2002-09-20

Application 021425

Related Records#

Application Products#

NDC Listings For This Application#

Documents#