Orange Book product · Brand (NDA)
CAPEX
FLUOCINOLONE ACETONIDE
At a glance
Aug 27, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 27, 1990
36 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOCINOLONE ACETONIDE
Strength
0.01%
Dosage form
SHAMPOO
Route
TOPICAL
TE code
Not listed
Application
NDA 020001
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 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.
