FDA Orange Book
Generic for Fml
Fml contains fluorometholone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Fml is fluorometholone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Fml products the Orange Book lists.
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Fml products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, ophthalmic | 0.1% | Discontinued | None | 0 | None |
| suspension/drops, ophthalmic | 0.1% | Marketed (Rx) | AB | 2 | AB |
NDA 017760, 016851, held by ALLERGAN PHARMACEUTICAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluorometholone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 216348 | AB (A-rated, therapeutically equivalent) | January 9, 2024 | 0.1% |
| SANDOZ INC | 218819 | AB (A-rated, therapeutically equivalent) | February 12, 2026 | 0.1% |
Fml NDC codes
Questions
Is there a generic for Fml?
Yes. The generic name for Fml is fluorometholone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Fml products the Orange Book lists.
What is the generic name for Fml?
The active ingredient in Fml is fluorometholone, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.