FDA Orange Book
Generic for Trisenox
Trisenox contains arsenic trioxide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Trisenox is arsenic trioxide. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Trisenox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1MG/ML | Discontinued | None | 9 | AP |
| injectable, injection | 2MG/ML | Marketed (Rx) | AP | 5 | AP |
NDA 021248, held by CEPHALON INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic arsenic trioxide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 208231 | AP (A-rated, therapeutically equivalent) | August 31, 2018 | 1MG/ML |
| J MOLNER HOLDINGS INC | 210802 | AP (A-rated, therapeutically equivalent) | November 13, 2018 | 1MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 206228 | AP (A-rated, therapeutically equivalent) | November 13, 2018 | 1MG/ML, 2MG/ML |
| INGENUS PHARMACEUTICALS LLC | 209315 | AP (A-rated, therapeutically equivalent) | November 15, 2018 | 1MG/ML |
| NEXUS PHARMACEUTICALS LLC | 209780 | AP (A-rated, therapeutically equivalent) | November 15, 2018 | 1MG/ML |
| PENN LIFE SCIENCES LLC | 209873 | AP (A-rated, therapeutically equivalent) | May 6, 2019 | 1MG/ML |
| AMNEAL EU LTD | 210739 | AP (A-rated, therapeutically equivalent) | January 25, 2021 | 1MG/ML, 2MG/ML |
| SANDOZ INC | 215359 | AP (A-rated, therapeutically equivalent) | December 2, 2021 | 2MG/ML |
| GLAND PHARMA LTD | 215059 | AP (A-rated, therapeutically equivalent) | April 22, 2022 | 1MG/ML, 2MG/ML |
| MSN LABORATORIES PRIVATE LTD | 217413 | AP (A-rated, therapeutically equivalent) | April 20, 2023 | 1MG/ML, 2MG/ML |
Trisenox NDC codes
Questions
Is there a generic for Trisenox?
Yes. The generic name for Trisenox is arsenic trioxide. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Trisenox?
The active ingredient in Trisenox is arsenic trioxide, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.