NDA 8032, held by Ge Healthcare. Iopanoic Acid.
As of Nov 13, 2026, NDA 8032 (Telepaque), held by Ge Healthcare, was first approved by FDA on Jul 16, 1951, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 1951 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Telepaque500MG · tablet;oral | Iopanoic Acid | Discontinued |
| May 2, 1990 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| May 20, 1987 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jul 1, 1986 | Supplement 21Labeling · Priority review | Approved | None posted |
| Nov 23, 1985 | Supplement 20Labeling · Priority review | Approved | None posted |
| Apr 19, 1985 | Supplement 19Labeling · Priority review | Approved | None posted |
| Mar 14, 1984 | Supplement 18Labeling · Priority review | Approved | None posted |
| Sep 30, 1983 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Nov 27, 1979 | Supplement 15Labeling · Priority review | Approved | None posted |
| Oct 12, 1978 | Supplement 13Labeling · Priority review | Approved | None posted |
| Oct 18, 1976 | Supplement 9Labeling · Priority review | Approved | None posted |
| Oct 15, 1976 | Supplement 10Labeling · Priority review | Approved | None posted |
| Oct 15, 1976 | Supplement 11Labeling · Priority review | Approved | None posted |
| Oct 15, 1976 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Jul 16, 1951 | Original applicationNew molecular entity · Priority 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
