Arsenic trioxide
ARSENIC TRIOXIDE INJECTION
Approved
Approval ID
25e8295c-b5d9-4322-a093-d907ab1d1d35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 650348852
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 Code49315-005
Application NumberANDA206228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Arsenic trioxide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (4)
ARSENIC TRIOXIDEActive
Quantity: 1 mg in 1 mL
Code: S7V92P67HO
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT