Cholovue

NDA 18076, held by Bracco. Iodoxamate Meglumine.

As of Nov 13, 2026, NDA 18076 (Cholovue), held by Bracco, was first approved by FDA on Aug 14, 1981, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 14, 1981
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 14, 1981	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cholovue40.3% · injectable;injection	Iodoxamate Meglumine	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 11, 1995	Supplement 3Labeling · Standard review	Approved	None posted
Aug 14, 1981	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 18076
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