Treats steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea…. ANDA 218256, held by Amneal. Prednisolone Acetate.
As of Nov 15, 2026, ANDA 218256 (Prednisolone Acetate), held by Amneal, was first approved by FDA on Jun 11, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone Acetate1% · suspension/drops;ophthalmic | Prednisolone Acetate | Rx |
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
