Orange Book product · Generic (ANDA)
FLUOROMETHOLONE
FLUOROMETHOLONE
Generic (ANDA)ANDA 218819TE ABRX SANDOZ
At a glance
Feb 12, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 12, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOROMETHOLONE
Strength
0.1%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
ANDA 218819
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUOROMETHOLONE
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.
