Treats corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva…. ANDA 218819, held by Sandoz. Fluorometholone.
As of Nov 15, 2026, ANDA 218819 (Fluorometholone), held by Sandoz, was first approved by FDA on Feb 12, 2026, 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 |
|---|---|---|---|
| Feb 12, 2026 | 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
