Isopaque 440

NDA 16847, held by Ge Healthcare. Calcium Metrizoate; Meglumine Metrizoate; Metrizoate Magnesium; Metrizoate Sodium.

As of Nov 14, 2026, NDA 16847 (Isopaque 440), held by Ge Healthcare, was first approved by FDA on Nov 17, 1973, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 17, 1973
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 17, 1973	Original applicationTYPE 2/4 · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isopaque 4400.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML · injectable;injection	Calcium Metrizoate; Meglumine Metrizoate; Metrizoate Magnesium; Metrizoate Sodium	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Feb 15, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 1, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 14, 1977	Supplement 4Labeling	Approved	None posted
Sep 14, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 10, 1977	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 26, 1976	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 21, 1975	Supplement 3Labeling	Approved	None posted
Nov 17, 1973	Original applicationTYPE 2/4 · Standard review	Approved	None posted

Identifiers

Application: NDA 16847
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