Fluorometholone
Fluorometholone: 4 brands, 3 generics; first approved Jul 28, 1982; generic available.
Generic available: 3 ANDA applications approved.
Brand (NDA) products
- ABBVIENDA 0192161986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SUSPENSION/DROPS OPHTHALMIC Rx — - FMLRLDALLERGANNDA 0177601985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT OPHTHALMIC Discontinued — - ABBVIENDA 0168511982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SUSPENSION/DROPS OPHTHALMIC Rx AB - PHARMACIA AND UPJOHNNDA 011748—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025% CREAM TOPICAL Discontinued —
Generic (ANDA) products (3)
- FLUOROMETHOLONESANDOZANDA 2188192026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SUSPENSION/DROPS OPHTHALMIC Rx AB - FLUOROMETHOLONEAMNEALANDA 2163482024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SUSPENSION/DROPS OPHTHALMIC Rx AB - NOVARTISANDA 0701851986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SUSPENSION/DROPS OPHTHALMIC Discontinued —
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1982–2026 across 7 FDA applications.
Fluorometholone: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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