Orange Book product · Brand (NDA)
RETISERT
FLUOCINOLONE ACETONIDE
At a glance
Apr 08, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 2005
21 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOCINOLONE ACETONIDE
Strength
0.59MG
Dosage form
IMPLANT
Route
INTRAVITREAL
TE code
Not listed
Application
NDA 021737
Product number
001
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.
- 2018YUTIQBrand (NDA)
NDA 210331 · ALIMERA SCIENCES INC
- 2014ILUVIENBrand (NDA)
NDA 201923 · ALIMERA SCIENCES INC
- 2005DERMOTICBrand (NDA)
NDA 019452 · HILL DERMAC
- —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
- 2018FLUOCINONIDE ACETONIDEGeneric (ANDA)
ANDA 211815 · GLENMARK PHARMS LTD
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.
