Visipaque 270, Visipaque 320

Used in scans for suspected coronary artery disease (320 mg Iodine/mL). NDA 20808, held by Ge Healthcare. Iodixanol.

As of Nov 13, 2026, NDA 20808 (Visipaque 270, Visipaque 320), held by Ge Healthcare, was first approved by FDA on Aug 29, 1997, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1997
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VISIPAQUE is indicated for: VISIPAQUE injection is a radiographic contrast agent indicated for the following: Intra-arterial Procedures Adults and pediatric patients 12 years of age and over Intra-arterial digital subtraction angiography (270 and 320 mg Iodine/mL). Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL). Pediatric patients less than 12 years of age Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 5, 2017	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 29, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Visipaque 27055% · injectable;injection	Iodixanol	Discontinued
Visipaque 32065.2% · injectable;injection	Iodixanol	Rx

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 25, 2023	Supplement 35Labeling · Standard review	Approved	Letter Label
Feb 18, 2022	Supplement 32Labeling · Standard review	Approved	Label
Mar 12, 2019	Supplement 28Labeling · Standard review	Approved	Letter Label
Apr 5, 2017	Supplement 26Labeling · Standard review	Approved	Letter Label
Apr 5, 2017	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jul 6, 2015	Supplement 24Labeling · Standard review	Approved	Letter Label
Jan 18, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 18, 2003	Supplement 4Labeling · Standard review	Approved	Label Letter
Sep 4, 2003	Supplement 2Manufacturing · Standard review	Approved	Letter
Jan 28, 1999	Supplement 1Labeling · Standard review	Approved	Review
Aug 29, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20808
Drugs@FDA: Overview at FDA
Company: GE 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