NDA 16983, held by Liebel-Flarsheim. Iothalamate Meglumine.
As of Nov 13, 2026, NDA 16983 (Conray 30), held by Liebel-Flarsheim, was first approved by FDA on Aug 6, 1971, with 28 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 1985 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Jun 20, 1977 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Aug 6, 1971 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Conray 3030% · injectable;injection | Iothalamate Meglumine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2017 | Supplement 37Labeling · Standard review | Approved | |
| Jul 6, 2015 | Supplement 35Labeling | Approved | |
| Dec 19, 2013 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| May 10, 2013 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1999 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1995 | Supplement 28Labeling · Standard review | Approved | None posted |
| Dec 4, 1992 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1992 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1990 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 1, 1989 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1989 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1989 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1989 | Supplement 24Labeling | Approved | None posted |
| Sep 9, 1985 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Apr 8, 1985 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Dec 4, 1984 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1984 | Supplement 19Labeling | Approved | None posted |
| Jun 25, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 16, 1982 | Supplement 15Labeling | Approved | None posted |
| Aug 16, 1982 | Supplement 13Labeling | Approved | None posted |
| Aug 24, 1981 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1977 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Sep 8, 1976 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 5, 1976 | Supplement 10Labeling | Approved | None posted |
| May 5, 1976 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1976 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1976 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1975 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1971 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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