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FDA Approval

Trisenox

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

FDA Approval Summary

Company
Cephalon, LLC
DUNS: 183236314
Effective Date
June 30, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Arsenic trioxide(2 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trisenox

Product Details

NDC Product Code
63459-601
Application Number
NDA021248
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
June 30, 2022
Code: S7V92P67HOClass: ACTIBQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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