Orange Book product · Generic (ANDA)
FLUOROMETHOLONE
FLUOROMETHOLONE
Generic (ANDA)ANDA 216348TE ABRX AMNEAL
At a glance
Jan 09, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 09, 2024
2 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOROMETHOLONE
Strength
0.1%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
ANDA 216348
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.

