NDA 5319, held by Alcon. Iophendylate.
As of Nov 13, 2026, NDA 5319 (Pantopaque), held by Alcon, was not approved, with 1 approved supplement and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Pantopaque100% ยท injectable;injection | Iophendylate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 21, 1980 | Supplement 9Labeling | 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
