Used in scans for suspected coronary artery disease (320 mg Iodine/mL). NDA 20351, held by Ge Healthcare. Iodixanol.
As of Nov 13, 2026, NDA 20351 (Visipaque 270, Visipaque 320), held by Ge Healthcare, was first approved by FDA on Mar 22, 1996, with 25 approved supplements and 0 published complete response letters.
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).
| Apr 5, 2017 | Supplement 44Efficacy (new indication or use) · Priority review | Approved | |
| Oct 10, 1997 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 22, 1996 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Apr 25, 2023 | Supplement 57Labeling · Standard review | Approved | |
| Feb 18, 2022 | Supplement 54Labeling · Standard review | Approved | |
| Jul 2, 2020 | Supplement 50Labeling · Standard review | Approved | |
| May 8, 2020 | Supplement 52Labeling · Standard review | Approved | |
| Mar 12, 2019 | Supplement 48Labeling · Standard review | Approved | |
| Apr 5, 2017 | Supplement 45Labeling · Standard review | Approved | |
| Apr 5, 2017 | Supplement 44Efficacy (new indication or use) · Priority review | Approved | |
| Jul 6, 2015 | Supplement 43Labeling · Standard review | Approved | |
| Nov 20, 2013 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Sep 12, 2013 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Mar 5, 2007 | Supplement 26Manufacturing | Approved | None posted |
| Aug 25, 2005 | Supplement 21Manufacturing · Standard review | Approved | |
| Apr 20, 2005 | Supplement 20Manufacturing · Standard review | Approved | |
| Dec 30, 2004 | Supplement 18Labeling · Standard review | Approved | |
| Mar 24, 2004 | Supplement 16Manufacturing · Standard review | Approved | |
| Dec 18, 2003 | Supplement 13Labeling · Standard review | Approved | |
| Sep 4, 2003 | Supplement 11Manufacturing · Standard review | Approved | |
| Dec 3, 2002 | Supplement 10Manufacturing · Standard review | Approved | |
| Jun 5, 2002 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 1, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 5, 2001 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 11, 2001 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1997 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 10, 1997 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 22, 1996 | Original applicationNew molecular entity · Standard review | Approved | None posted |
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
