Isopaque 280

NDA 17506, held by Ge Healthcare. Calcium; Meglumine; Metrizoic Acid.

As of Nov 14, 2026, NDA 17506 (Isopaque 280), held by Ge Healthcare, was first approved by FDA on Apr 30, 1974, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1974
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 30, 1974	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isopaque 2800.35MG/ML;140.1MG/ML;461.8MG/ML · injectable;injection	Calcium; Meglumine; Metrizoic Acid	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 3Labeling	Approved	None posted
Feb 1, 1978	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 4, 1976	Supplement 2Labeling	Approved	None posted
Jun 10, 1974	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 30, 1974	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 17506
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