Orange Book product · Brand (NDA)
FLUOCINONIDE
FLUOCINONIDE
At a glance
Jun 26, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 1984
42 yr 7 mo ago
Today
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0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 019117
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
- 1984LIDEXBrand (NDA)
NDA 018849 · ALVOGEN
- —LIDEXBrand (NDA)
NDA 016908 · ALVOGEN
- —FLUOCINONIDEBrand (NDA)
NDA 017373 · 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.
