Orange Book product · Brand (NDA)
TRISENOX
ARSENIC TRIOXIDE
At a glance
Oct 13, 2017
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 13, 2017
8 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ARSENIC TRIOXIDE
Strength
2MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 021248
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.
- 2023ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 217413 · MSN
- 2022ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 215059 · GLAND
- 2021ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 215359 · SANDOZ
- 2021ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 214011 · EUGIA PHARMA
- 2021ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 210739 · AMNEAL
- 2019ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 209873 · PENN LIFE
- 2018ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 209315 · INGENUS PHARMS LLC
- 2018ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 209780 · NEXUS
- 2018ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 210802 · AMRING PHARMS
- 2018ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 206228 · ZYDUS PHARMS
- 2018ARSENIC TRIOXIDEGeneric (ANDA)
ANDA 208231 · FRESENIUS KABI USA
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.
