Ultravist 370, Ultravist 300, Ultravist 240

NDA 20220, held by Bayer Hlthcare. Iopromide.

As of Nov 13, 2026, NDA 20220 (Ultravist 370, Ultravist 300, Ultravist 240), held by Bayer Hlthcare, was first approved by FDA on May 10, 1995, with 30 approved supplements and 0 published complete response letters.

First approved: May 10, 1995
Review: Standard
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ULTRAVIST Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures †

Cerebral arteriography and peripheral arteriography in adults
Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults
Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older Intravenous Procedures †
Excretory urography in adults and pediatric patients aged 2 years and older
Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older
Contrast mammography in adults as an adjunct following mam…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


May 25, 2023	Supplement 54Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 30, 2009	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 23, 1997	Supplement 2Efficacy (new indication or use)	Approved	None posted
May 10, 1995	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

5 strengths and forms


Ultravist 37076.9% · injectable;injection	Iopromide	RxReference drug
Ultravist 30062.3% · injectable;injection	Iopromide	RxReference drug
Ultravist 24049.9% · injectable;injection	Iopromide	DiscontinuedReference drug
Ultravist 15031.2% · injectable;injection	Iopromide	DiscontinuedReference drug
Ultravist 300 In Plastic Container62.3% · injectable;injection	Iopromide	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


Jun 15, 2023	Supplement 55Labeling · Standard review	Approved	Letter Label
May 25, 2023	Supplement 54Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 25, 2023	Supplement 56Labeling · Standard review	Approved	Letter Label
Feb 18, 2022	Supplement 52Labeling · Standard review	Approved	Label Letter
Aug 1, 2019	Supplement 47Labeling · Standard review	Approved	Label Letter
Apr 24, 2018	Supplement 46Labeling · Standard review	Approved	Letter Label
Apr 2, 2018	Supplement 45Labeling · Standard review	Approved	Letter Label
Jul 27, 2017	Supplement 43Labeling · Standard review	Approved	Letter Label
Apr 5, 2017	Supplement 42Labeling · Standard review	Approved	Label Label
Jul 6, 2015	Supplement 41Labeling · Standard review	Approved	Letter Label
Jul 29, 2013	Supplement 40Manufacturing · Standard review	Approved	None posted
May 2, 2012	Supplement 36Labeling · Standard review	Approved	Label Letter
Dec 30, 2009	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 13, 2009	Supplement 35Manufacturing · Standard review	Approved	Letter
Aug 31, 2007	Supplement 27Labeling · Standard review	Approved	Letter Label
Aug 12, 2005	Supplement 22Labeling · Standard review	Approved	Letter
Mar 12, 2004	Supplement 18Manufacturing · Standard review	Approved	Label Letter
Apr 25, 2003	Supplement 8Labeling · Standard review	Approved	Letter
Oct 30, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 11, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 5, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 4, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 24, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 27, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 27, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 25, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 3, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 23, 1997	Supplement 2Efficacy (new indication or use)	Approved	None posted
Jun 5, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
May 30, 1995	Supplement 1Labeling · Standard review	Approved	None posted
May 10, 1995	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20220
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters