Vascoray

NDA 16783, held by Mallinckrodt. Iothalamate Meglumine; Iothalamate Sodium.

As of Nov 13, 2026, NDA 16783 (Vascoray), held by Mallinckrodt, was first approved by FDA on Jan 26, 1971, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 26, 1971
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Oct 18, 1978	Supplement 14Efficacy (new indication or use)	Approved	None posted
Jan 26, 1971	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vascoray52%;26% · injectable;injection	Iothalamate Meglumine; Iothalamate Sodium	Discontinued

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 13Labeling	Approved	None posted
Mar 13, 2009	Supplement 16Labeling	Approved	None posted
Jan 13, 1995	Supplement 29Labeling · Standard review	Approved	None posted
Dec 4, 1992	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 28, 1992	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 30, 1990	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 1, 1989	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 10, 1989	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 28, 1989	Supplement 25Labeling	Approved	None posted
Aug 19, 1988	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 23, 1985	Supplement 22Labeling	Approved	None posted
Dec 4, 1984	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 25, 1984	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 3, 1983	Supplement 18Labeling	Approved	None posted
Jun 16, 1982	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 25, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 18, 1978	Supplement 14Efficacy (new indication or use)	Approved	None posted
May 14, 1976	Supplement 12Labeling	Approved	None posted
May 10, 1976	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 23, 1976	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 23, 1976	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 30, 1975	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 26, 1971	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 16783
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