Conray 400

NDA 14295, held by Mallinckrodt. Iothalamate Sodium.

As of Nov 13, 2026, NDA 14295 (Conray 400), held by Mallinckrodt, was first approved by FDA on Sep 30, 1963, with 24 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1963
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below


Dec 14, 1978	Supplement 23Efficacy (new indication or use)	Approved	None posted
Sep 30, 1963	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Conray 40066.8% · injectable;injection	Iothalamate Sodium	Discontinued

All 25 submissions, including labeling and manufacturing supplements


Jan 13, 1995	Supplement 42Labeling · Standard review	Approved	None posted
Dec 4, 1992	Supplement 40Manufacturing · Standard review	Approved	None posted
Aug 28, 1992	Supplement 41Manufacturing · Standard review	Approved	None posted
Aug 28, 1992	Supplement 37Manufacturing · Standard review	Approved	None posted
Mar 30, 1990	Supplement 39Manufacturing · Standard review	Approved	None posted
Dec 1, 1989	Supplement 36Manufacturing · Standard review	Approved	None posted
Oct 10, 1989	Supplement 34Manufacturing · Standard review	Approved	None posted
Jul 3, 1989	Supplement 38Labeling	Approved	None posted
Aug 19, 1988	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 4, 1984	Supplement 31Manufacturing · Standard review	Approved	None posted
Sep 12, 1984	Supplement 33Labeling	Approved	None posted
Jun 25, 1984	Supplement 30Manufacturing · Standard review	Approved	None posted
Jun 19, 1984	Supplement 32Labeling	Approved	None posted
Apr 8, 1983	Supplement 29Labeling	Approved	None posted
May 10, 1982	Supplement 28Labeling	Approved	None posted
Aug 27, 1981	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 14, 1978	Supplement 23Efficacy (new indication or use)	Approved	None posted
Aug 29, 1978	Supplement 24Manufacturing · Standard review	Approved	None posted
May 30, 1978	Supplement 22Labeling	Approved	None posted
May 5, 1976	Supplement 21Labeling	Approved	None posted
May 5, 1976	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 23, 1976	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 23, 1976	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 30, 1975	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 30, 1963	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 14295
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