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FDA Approval

Doxorubicin Hydrochloride

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

FDA Approval Summary

Effective Date
October 20, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Doxorubicin(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.

Doxorubicin Hydrochloride

Product Details

NDC Product Code
70860-208
Application Number
ANDA209825
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
October 20, 2017
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
Code: 82F2G7BL4EClass: ACTIBQuantity: 2 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
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