Application 020220

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTRAVIST 370	IOPROMIDE	INJECTABLE;INJECTION	76.9%	Yes	Yes
002	ULTRAVIST 300	IOPROMIDE	INJECTABLE;INJECTION	62.3%	Yes	Yes
003	ULTRAVIST 240	IOPROMIDE	INJECTABLE;INJECTION	49.9%	Yes	No
004	ULTRAVIST 150	IOPROMIDE	INJECTABLE;INJECTION	31.2%	Yes	No
005	ULTRAVIST 300 IN PLASTIC CONTAINER	IOPROMIDE	INJECTABLE;INJECTION	62.3%	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
50419-346	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
74558	SUPPL	2023-06-21
74556	SUPPL	2023-06-20
74387	SUPPL	2023-05-26
74375	SUPPL	2023-05-26
74077	SUPPL	2023-04-27
74066	SUPPL	2023-04-26
70254	SUPPL	2022-02-25
70215	SUPPL	2022-02-22
59565	SUPPL	2019-08-02
59548	SUPPL	2019-08-02
53866	SUPPL	2018-04-27
53823	SUPPL	2018-04-26
53600	SUPPL	2018-04-04
53599	SUPPL	2018-04-04
49181	SUPPL	2017-08-02
49149	SUPPL	2017-07-31
47960	SUPPL	2017-04-12
47885	SUPPL	2017-04-07
2183	SUPPL	2015-07-10
12328	SUPPL	2015-07-09
12327	SUPPL	2012-05-07
2182	SUPPL	2012-05-04
24594	SUPPL	2010-01-20
12326	SUPPL	2010-01-08
24593	SUPPL	2010-01-05
24592	SUPPL	2007-09-06
34386	SUPPL	2007-09-04
2181	SUPPL	2005-08-15
34385	SUPPL	2004-04-05
24591	SUPPL	2004-03-16
2180	SUPPL	2003-05-29

Application 020220

Related Records#

Application Products#

NDC Listings For This Application#

Documents#