Isovue-200, Isovue-250, Isovue-300

NDA 20327, held by Bracco. Iopamidol.

As of Nov 14, 2026, NDA 20327 (Isovue-200, Isovue-250, Isovue-300), held by Bracco, was first approved by FDA on Oct 12, 1994, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 12, 1994
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ISOVUE is a radiographic contrast agent indicated for: Intra-arterial Procedures † Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac ventriculography in adults Angiocardiography in pediatric patients Intravenous Procedures † Excretory urography in adults and pediatric patients Computed tomography (CT) of head and body in adults and pediatric patients Peripheral venography in adults † Specific concentrations are recommended for each type of imaging procedure. ( 2.2, 2.3, 2.4 ) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 12, 1994	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Isovue-20041% · injectable;injection	Iopamidol	Discontinued
Isovue-25051% · injectable;injection	Iopamidol	DiscontinuedReference drug
Isovue-30061% · injectable;injection	Iopamidol	RxReference drug
Isovue-37076% · injectable;injection	Iopamidol	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Jan 13, 2026	Supplement 28Labeling · Standard review	Approved	Letter Label
Apr 25, 2023	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 18, 2022	Supplement 23Labeling · Standard review	Approved	Label Letter
Feb 16, 2018	Supplement 14Labeling · Standard review	Approved	Letter Label
Apr 5, 2017	Supplement 12Labeling · Standard review	Approved	Letter Label
Jan 22, 2016	Supplement 11Labeling · Standard review	Approved	Label Letter
Jul 6, 2015	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 20, 2014	Supplement 8Labeling · Standard review	Approved	Letter Label
Aug 1, 2012	Supplement 7Labeling · Standard review	Approved	Letter Label
Jul 26, 2005	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 5, 2003	Supplement 4Manufacturing · Standard review	Approved	Letter
Jun 20, 2002	Supplement 2Labeling · Standard review	Approved	Letter
Dec 9, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 17, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 12, 1994	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20327
Drugs@FDA: Overview at FDA
Company: Bracco

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