Orange Book product · Generic (ANDA)
FLAC
FLUOCINOLONE ACETONIDE
At a glance
Apr 11, 2018
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 11, 2018
8 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOCINOLONE ACETONIDE
Strength
0.01%
Dosage form
OIL/DROPS
Route
OTIC
TE code
AT
Application
ANDA 210736
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUOCINOLONE ACETONIDE
- 2018YUTIQBrand (NDA)
NDA 210331 · ALIMERA SCIENCES INC
- 2014ILUVIENBrand (NDA)
NDA 201923 · ALIMERA SCIENCES INC
- 2005DERMOTICBrand (NDA)
NDA 019452 · HILL DERMAC
- 2005RETISERTBrand (NDA)
NDA 021737 · BAUSCH AND LOMB
- —SYNALARBrand (NDA)
NDA 012787 · EUROFARMA
- —SYNALAR-HPBrand (NDA)
NDA 016161 · EUROFARMA
- 2023FLUOCINOLONE ACETONIDEGeneric (ANDA)
ANDA 207347 · NOVEL LABS INC
- 2023FLUOCINOLONE ACETONIDEGeneric (ANDA)
ANDA 207345 · NOVEL LABS INC
- 2021FLUOCINOLONE ACETONIDEGeneric (ANDA)
ANDA 212762 · QUAGEN
- 2021FLUOCINOLONE ACETONIDEGeneric (ANDA)
ANDA 212760 · QUAGEN
- 2021FLUOCINOLONE ACETONIDEGeneric (ANDA)
ANDA 212761 · QUAGEN
- 2021FLUOCINOLONE ACETONIDEGeneric (ANDA)
ANDA 213264 · TP ANDA HOLDINGS
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.
