Orange Book product · Brand (NDA)
YUTIQ
FLUOCINOLONE ACETONIDE
At a glance
Oct 12, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 12, 2018
7 yr 10 mo ago
Today
Patent 8871241 expires
Listed drug product patent expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 7998108 expires
Listed drug product patent expiration.
Jan 12, 2028
in 1 yr 7 mo
Pharmaceutical detail
Active ingredient
FLUOCINOLONE ACETONIDE
Strength
0.18MG
Dosage form
IMPLANT
Route
INTRAVITREAL
TE code
Not listed
Application
NDA 210331
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.
- 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
- 2018FLUOCINONIDE ACETONIDEGeneric (ANDA)
ANDA 211815 · GLENMARK PHARMS LTD
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8871241 | Aug 12, 2027 | in 1 yr 2 mo | Product |
| 7998108 | Jan 12, 2028 | in 1 yr 7 mo | ProductU-3410 |

