FDA Orange Book · active-ingredient family
Arsenic trioxide
Arsenic trioxide: 1 brand, 11 generics; first approved Sep 25, 2000; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
11
Listed patents
0
Presentations
18
Brand (NDA) products
Originator applications
- TRISENOXRLDCEPHALONNDA 02124820002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (11)
Abbreviated applications
- ARSENIC TRIOXIDEMSNANDA 21741320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP - ARSENIC TRIOXIDEGLANDANDA 21505920222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 1MG/ML INJECTABLE INJECTION Rx AP - ARSENIC TRIOXIDESANDOZANDA 2153592021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - ARSENIC TRIOXIDEEUGIA PHARMAANDA 2140112021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - ARSENIC TRIOXIDEAMNEALANDA 21073920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP - ARSENIC TRIOXIDEPENN LIFEANDA 2098732019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - ARSENIC TRIOXIDEINGENUS PHARMS LLCANDA 20931520182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Discontinued — - ARSENIC TRIOXIDENEXUSANDA 2097802018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - ARSENIC TRIOXIDEJ MOLNERANDA 2108022018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - ARSENIC TRIOXIDEZYDUS PHARMSANDA 20622820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP - ARSENIC TRIOXIDERSFRESENIUS KABI USAANDA 2082312018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
26 yr 4 mo ago
Most recent approval
3 yr 5 mo ago
Approvals span 2000–2023 across 12 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1192%
Arsenic trioxide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
