Orange Book product · Brand (NDA)
CYCLOCORT
AMCINONIDE
At a glance
Jun 13, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 13, 1988
38 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
AMCINONIDE
Strength
0.1%
Dosage form
LOTION
Route
TOPICAL
TE code
Not listed
Application
NDA 019729
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.
- —CYCLOCORTBrand (NDA)
NDA 018116 · ASTELLAS
- —CYCLOCORTBrand (NDA)
NDA 018498 · ASTELLAS
- 2003AMCINONIDEGeneric (ANDA)
ANDA 076065 · GENUS LIFESCIENCES
- 2003AMCINONIDEGeneric (ANDA)
ANDA 076367 · TARO PHARM INDS
- 2002AMCINONIDEGeneric (ANDA)
ANDA 076096 · GENUS
- 2002AMCINONIDEGeneric (ANDA)
ANDA 076329 · SOLUBIOMIX
- 2002AMCINONIDEGeneric (ANDA)
ANDA 076229 · TARO PHARM INDS
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.
