NDA 11028, held by Merck. Prednisolone Sodium Phosphate.
As of Nov 13, 2026, NDA 11028 (Hydeltrasol), held by Merck, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| HydeltrasolEQ 0.25% PHOSPHATE ยท ointment;ophthalmic, otic | Prednisolone Sodium Phosphate | 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
