NDA 8414, held by Roche. Sulfisoxazole Diolamine.
As of Nov 14, 2026, NDA 8414 (Gantrisin), held by Roche, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| GantrisinEQ 4% BASE ยท ointment;ophthalmic | Sulfisoxazole Diolamine | Discontinued |
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
