Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
MSN Laboratories Private Limited
Orbicular Pharmaceutical Technologies Private Limited
650786952
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ARSENIC TRIOXIDE
Product Details
NDC Product Code
81607-006Application Number
ANDA217413Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
May 4, 2023Arsenic trioxideActive
Code: S7V92P67HOClass: ACTIBQuantity: 2 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
ARSENIC TRIOXIDE
Product Details
NDC Product Code
81607-005Application Number
ANDA217413Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
May 4, 2023SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Arsenic trioxideActive
Code: S7V92P67HOClass: ACTIBQuantity: 1 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT