FDA Orange Book · active-ingredient family
Fluorometholone
Fluorometholone is approved as 4 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FML FORTE · NDA 019216
4
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, ointment, suspension/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FML FORTERLD | ABBVIE | NDA 019216 | — | Apr 23, 1986 | |
| FMLRLD | ALLERGAN | NDA 017760 | — | Sep 04, 1985 | |
| FMLRLD | ABBVIE | NDA 016851 | AB | Jul 28, 1982 | |
| OXYLONE | PHARMACIA AND UPJOHN | NDA 011748 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUOROMETHOLONE | SANDOZ | ANDA 218819 | AB | Feb 12, 2026 | |
| FLUOROMETHOLONE | AMNEAL | ANDA 216348 | AB | Jan 09, 2024 | |
| FLUOR-OP | NOVARTIS | ANDA 070185 | — | Feb 27, 1986 |
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.
Fluorometholone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
