Orange Book product · Brand (NDA)
FML
FLUOROMETHOLONE
Brand (NDA)NDA 016851TE ABRX ABBVIE
At a glance
Jul 28, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 28, 1982
44 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOROMETHOLONE
Strength
0.1%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
NDA 016851
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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.
