Active ingredient
Fluorometholone
8 finished FDA listings contain Fluorometholone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FLUOROMETHOLONE, FLUOROMETHOLONE ACETATE
- Dosage forms
- Solution/ Drops, Suspension/ Drops
- Routes
- Ophthalmic
- Manufacturers / labelers
- 6
- Strengths listed
- 1 mg/ml · 2.5 mg/ml
- Brand names in FDA listings
- Flarex, Fluorometholone Ophthalmic Suspension, Fml, Fml Forte
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4491
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 016851 | ABBVIE | 1972-01-12 | 2 |
| NDA 019079 | HARROW EYE | 1986-02-11 | 2 |
| NDA 019216 | ABBVIE | 1986-04-23 | 1 |
| ANDA 216348 | AMNEAL | 2024-01-09 | 2 |
| ANDA 218819 | SANDOZ | 2026-02-12 | 1 |
Official labeling on DailyMed
- FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] · version 12 · 2026-08-27
- FLUOROMETHOLONE OPHTHALMIC SUSPENSION (FLUOROMETHOLONE) SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS LLC] · version 8 · 2026-08-17
- FLUOROMETHOLONE SUSPENSION/ DROPS [SANDOZ INC] · version 3 · 2026-07-13
- FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] · version 14 · 2025-09-29
- FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION/ DROPS [HARROW EYE, LLC] · version 2 · 2025-04-03
- FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] · version 16 · 2025-02-24
- FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION/ DROPS [EYEVANCE PHARMACEUTICALS] · version 7 · 2025-01-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.