Drug
Who makes fluorometholone?
4 companies list fluorometholone as a human prescription drug, including under the names FML, FML FORTE. Forms: solution/ drops; suspension/ drops. Routes: ophthalmic.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing fluorometholone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Allergan, Inc.United States | suspension/ drops | NDANDA016851, NDA019216 | 2 | 7 |
| Amneal Ireland LimitedIreland | suspension/ drops | ANDAANDA216348 | 2 | 1 |
| Sandoz Industrial Products S.AAustria | suspension/ drops | ANDAANDA218819 | 1 | 5 |
| Pacific Medical Industries LtdUnited States | solution/ drops | NDA AUTHORIZED GENERICNDA016851 | 1 | 4 |
Bulk ingredient listings
- EUROAPIFrance · 2 NDC
- Farmabios S.p.A.Italy · 1 NDC
- Symbiotec Pharmalab LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes fluorometholone?
- 4 companies list fluorometholone as a human prescription drug in the openFDA NDC Directory, led by Allergan, Inc., Amneal Ireland Limited, Sandoz Industrial Products S.A, Pacific Medical Industries Ltd. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic FML?
- 2 companies list fluorometholone under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fluorometholone active ingredient?
- 3 companies list fluorometholone as a bulk ingredient, including EUROAPI, Farmabios S.p.A., Symbiotec Pharmalab Limited.