ARSENIC TRIOXIDE
These highlights do not include all the information needed to use ARSENIC TRIOXIDE INJECTION safely and effectively. See full prescribing information for ARSENIC TRIOXIDE INJECTION. ARSENIC TRIOXIDE injection, for intravenous useInitial U.S. Approval: 2000
Approved
Approval ID
d921f52f-2f38-4300-ae40-31f00b3a500a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Sintetica US LLC
DUNS: 118837338
Products 2
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 Code83090-009
Application NumberANDA217413
Product Classification
M
Marketing Category
C73584
G
Generic Name
arsenic trioxide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ARSENIC TRIOXIDEActive
Quantity: 1 mg in 1 mL
Code: S7V92P67HO
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
arsenic trioxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83090-010
Application NumberANDA217413
Product Classification
M
Marketing Category
C73584
G
Generic Name
arsenic trioxide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (4)
ARSENIC TRIOXIDEActive
Quantity: 2 mg in 1 mL
Code: S7V92P67HO
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT