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FDA Approval

Arsenic Trioxide

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 23, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Arsenic trioxide(2 mg in 1 mL)

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
70121-1658
Application Number
ANDA210739
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
July 23, 2021
Code: S7V92P67HOClass: ACTIBQuantity: 2 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Arsenic Trioxide

Product Details

NDC Product Code
70121-1483
Application Number
ANDA210739
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
July 23, 2021
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: S7V92P67HOClass: ACTIBQuantity: 1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
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