Renovue-65

NDA 17902, held by Bracco. Iodamide Meglumine.

As of Nov 13, 2026, NDA 17902 (Renovue-65), held by Bracco, was first approved by FDA on Jul 25, 1978, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 25, 1978
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 26, 1983	Supplement 4Efficacy (new indication or use)	Approved	None posted
Jul 25, 1978	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Renovue-6565% · injectable;injection	Iodamide Meglumine	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 3Labeling	Approved	None posted
May 11, 1995	Supplement 8Labeling · Standard review	Approved	None posted
Mar 21, 1993	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 6, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 22, 1983	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 26, 1983	Supplement 4Efficacy (new indication or use)	Approved	None posted
Jul 25, 1980	Supplement 1Labeling	Approved	None posted
Jul 4, 1980	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 25, 1978	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 17902
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