FDA Orange Book · active-ingredient family
Arsenic trioxide
Arsenic trioxide is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRISENOX · NDA 021248
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRISENOXRLD×2 | CEPHALON | NDA 021248 | — | Sep 25, 2000 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARSENIC TRIOXIDE×2 | MSN | ANDA 217413 | AP | Apr 20, 2023 | |
| ARSENIC TRIOXIDE×2 | GLAND | ANDA 215059 | AP | Apr 22, 2022 | |
| ARSENIC TRIOXIDE | SANDOZ | ANDA 215359 | AP | Dec 02, 2021 | |
| ARSENIC TRIOXIDE | EUGIA PHARMA | ANDA 214011 | — | Oct 15, 2021 | |
| ARSENIC TRIOXIDE×2 | AMNEAL | ANDA 210739 | AP | Jan 25, 2021 | |
| ARSENIC TRIOXIDE | PENN LIFE | ANDA 209873 | AP | May 06, 2019 | |
| ARSENIC TRIOXIDE×2 | INGENUS PHARMS LLC | ANDA 209315 | AP | Nov 15, 2018 | |
| ARSENIC TRIOXIDE | NEXUS | ANDA 209780 | AP | Nov 15, 2018 | |
| ARSENIC TRIOXIDE | AMRING PHARMS | ANDA 210802 | AP | Nov 13, 2018 | |
| ARSENIC TRIOXIDE×2 | ZYDUS PHARMS | ANDA 206228 | AP | Nov 13, 2018 | |
| ARSENIC TRIOXIDE | FRESENIUS KABI USA | ANDA 208231 | AP | Aug 31, 2018 |
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.
Arsenic trioxide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
