Conray 325

NDA 17685, held by Mallinckrodt. Iothalamate Sodium.

As of Nov 13, 2026, NDA 17685 (Conray 325), held by Mallinckrodt, was first approved by FDA on Sep 7, 1976, with 15 approved supplements and 0 published complete response letters.

First approved: Sep 7, 1976
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Sep 7, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Conray 32554.3% · injectable;injection	Iothalamate Sodium	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 3Labeling	Approved	None posted
Mar 13, 2009	Supplement 5Labeling	Approved	None posted
Jan 13, 1995	Supplement 15Labeling · Standard review	Approved	None posted
Dec 4, 1992	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 28, 1992	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 28, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 30, 1990	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 1, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 10, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 5, 1985	Supplement 8Labeling	Approved	None posted
Dec 4, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 25, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 24, 1981	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 22, 1979	Supplement 1Labeling	Approved	None posted
Sep 6, 1978	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 7, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17685
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