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 use Initial U.S. Approval: 2000
Approved
Approval ID
d1e2107c-26c3-40fc-978e-0ba5b84098ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Amring Pharmaceuticals Inc.
DUNS: 079843051
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 Code69918-720
Application NumberANDA210802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Arsenic Trioxide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2023
FDA Product Classification
INGREDIENTS (4)
ARSENIC TRIOXIDEActive
Quantity: 1 mg in 1 mL
Code: S7V92P67HO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT