Angio-Conray

NDA 13319, held by Mallinckrodt. Iothalamate Sodium.

As of Nov 14, 2026, NDA 13319 (Angio-Conray), held by Mallinckrodt, was first approved by FDA on Apr 26, 1996, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1996
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
Apr 26, 1996	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Angio-Conray80% · injectable;injection	Iothalamate Sodium	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Apr 26, 1996	Supplement 25Labeling	Approved	None posted
Apr 26, 1996	Supplement 24Labeling	Approved	None posted
Apr 26, 1996	Supplement 22Labeling	Approved	None posted
Apr 26, 1996	Supplement 19Labeling	Approved	None posted
Apr 26, 1996	Original applicationNew active ingredient · Standard review	Approved	None posted
Jun 28, 1989	Supplement 33Labeling	Approved	None posted
Apr 16, 1985	Supplement 30Labeling	Approved	None posted
Oct 19, 1982	Supplement 27Labeling	Approved	None posted
May 6, 1976	Supplement 21Labeling	Approved	None posted

Identifiers

Application: NDA 13319
Drugs@FDA: Overview at FDA
Company: Mallinckrodt

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