Orange Book product · Brand (NDA)
KENALOG-80
TRIAMCINOLONE ACETONIDE
At a glance
Apr 12, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 12, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
TRIAMCINOLONE ACETONIDE
Strength
80MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 014901
Product number
002
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.
- 1991NASACORTBrand (NDA)
NDA 019798 · CHATTEM SANOFI
- 1982AZMACORTBrand (NDA)
NDA 018117 · ABBVIE
- —TRIAMCINOLONE ACETONIDEBrand (NDA)
NDA 011601 · NORVIUM BIOSCIENCE
- 2019TRIAMCINOLONE ACETONIDEGeneric (ANDA)
ANDA 210346 · STRIDES PHARMA
- 2018TRIAMCINOLONE ACETONIDEGeneric (ANDA)
ANDA 209535 · MACLEODS PHARMS LTD
- 2017TRIAMCINOLONE ACETONIDEGeneric (ANDA)
ANDA 207651 · ALKEM LABS LTD
- 2017TRIAMCINOLONE ACETONIDEGeneric (ANDA)
ANDA 208848 · ENCUBE
- 2017TRIAMCINOLONE ACETONIDEGeneric (ANDA)
ANDA 208763 · CHARTWELL RX
- 2016TRIAMCINOLONE ACETONIDEGeneric (ANDA)
ANDA 207117 · GLENMARK PHARMS LTD
- 2015TRIDERMGeneric (ANDA)
ANDA 088042 · CROWN LABS
- 2006TRIAMCINOLONE ACETONIDEGeneric (ANDA)
ANDA 040671 · MICRO LABS
- 1997TRIAMCINOLONE ACETONIDEGeneric (ANDA)
ANDA 040039 · TARO
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.
