Treats corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva…. ANDA 216348, held by Amneal. Fluorometholone.
As of Nov 15, 2026, ANDA 216348 (Fluorometholone), held by Amneal, was first approved by FDA on Jan 9, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 9, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorometholone0.1% · suspension/drops;ophthalmic | Fluorometholone | 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
