Ultravist (Pharmacy Bulk)

NDA 21425, held by Bayer Hlthcare. Iopromide.

As of Nov 15, 2026, NDA 21425 (Ultravist (Pharmacy Bulk)), held by Bayer Hlthcare, was first approved by FDA on Sep 20, 2002, with 16 approved supplements and 0 published complete response letters.

First approved: Sep 20, 2002
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


May 25, 2023	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 23, 2010	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 20, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Ultravist (Pharmacy Bulk)62.3% · injectable;injection	Iopromide	RxReference drug
Ultravist (Pharmacy Bulk)76.9% · injectable;injection	Iopromide	RxReference drug
Ultravist (Pharmacy Bulk)49.9% · injectable;injection	Iopromide	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Jun 15, 2023	Supplement 37Labeling · Standard review	Approved	Letter Label
May 25, 2023	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 25, 2023	Supplement 38Labeling · Standard review	Approved	Letter Label
Feb 18, 2022	Supplement 34Labeling · Standard review	Approved	Label Letter
Aug 1, 2019	Supplement 30Labeling · Standard review	Approved	Label Letter
May 4, 2018	Supplement 29Manufacturing	Approved	Letter
Apr 2, 2018	Supplement 28Labeling · Standard review	Approved	Letter Label
Apr 5, 2017	Supplement 26Labeling · Standard review	Approved	Letter Label
Nov 17, 2016	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 6, 2015	Supplement 24Labeling · Standard review	Approved	Letter Label
May 2, 2012	Supplement 20Labeling · Standard review	Approved	Label
Jun 23, 2010	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 13, 2009	Supplement 19Manufacturing · Standard review	Approved	Letter
Aug 31, 2007	Supplement 12Labeling · Standard review	Approved	Letter Label
Mar 12, 2004	Supplement 6Manufacturing · Standard review	Approved	Label Letter
Jan 23, 2003	Supplement 1Labeling · Standard review	Approved	Letter
Sep 20, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21425
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