Arsenic Trioxide
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2000
Approved
Approval ID
f684f18f-afae-4430-a6af-63aae21b3571
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
STI Pharma LLC
DUNS: 832714070
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Arsenic Trioxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54879-027
Application NumberANDA209873
Product Classification
M
Marketing Category
C73584
G
Generic Name
Arsenic Trioxide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ARSENIC TRIOXIDEActive
Quantity: 1 mg in 1 mL
Code: S7V92P67HO
Classification: ACTIB