NDA 15868, held by Glaxosmithkline. Idoxuridine.
As of Nov 15, 2026, NDA 15868 (Stoxil), held by Glaxosmithkline, was first approved by FDA on Sep 2, 1967, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 1967 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Stoxil0.5% · ointment;ophthalmic | Idoxuridine | Discontinued |
| Jun 25, 1987 | Supplement 10Labeling | Approved | None posted |
| Aug 19, 1981 | Supplement 11Labeling | Approved | None posted |
| Feb 20, 1980 | Supplement 8Labeling | Approved | None posted |
| Jul 15, 1976 | Supplement 7Labeling | Approved | None posted |
| Sep 2, 1967 | Original applicationNew dosage form · 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
