Orange Book product · Brand (NDA)
FLUOCINONIDE
FLUOCINONIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
FLUOCINONIDE
Strength
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 017373
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.
- 2005VANOSBrand (NDA)
NDA 021758 · BAUSCH
- 1984FLUOCINONIDEBrand (NDA)
NDA 019117 · SUN PHARMA CANADA
- 1984LIDEXBrand (NDA)
NDA 018849 · ALVOGEN
- —LIDEXBrand (NDA)
NDA 016908 · ALVOGEN
- —LIDEXBrand (NDA)
NDA 016909 · ALVOGEN
- 2025FLUOCINONIDEGeneric (ANDA)
ANDA 216389 · QUAGEN
- 2020FLUOCINONIDEGeneric (ANDA)
ANDA 208989 · ZYDUS LIFESCIENCES
- 2019FLUOCINONIDEGeneric (ANDA)
ANDA 212976 · XIROMED
- 2019FLUOCINONIDEGeneric (ANDA)
ANDA 211758 · ENCUBE
- 2019FLUOCINONIDEGeneric (ANDA)
ANDA 207554 · SCIEGEN PHARMS
- 2018FLUOCINONIDEGeneric (ANDA)
ANDA 209699 · ENCUBE ETHICALS
- 2018FLUOCINONIDEGeneric (ANDA)
ANDA 211410 · ENCUBE
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.
