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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

Company
Effective Date
January 16, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Doxorubicin(2 mg in 1 mL)

Products4

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
0143-9087
Application Number
ANDA064097
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
January 16, 2024
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Code: 82F2G7BL4EClass: ACTIBQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL

Doxorubicin Hydrochloride

Product Details

NDC Product Code
0143-9085
Application Number
ANDA062975
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
January 16, 2024
Code: 82F2G7BL4EClass: ACTIBQuantity: 2 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL

Doxorubicin Hydrochloride

Product Details

NDC Product Code
0143-9086
Application Number
ANDA062975
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
January 16, 2024
Code: 82F2G7BL4EClass: ACTIBQuantity: 2 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL

Doxorubicin Hydrochloride

Product Details

NDC Product Code
0143-9084
Application Number
ANDA062975
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
January 16, 2024
Code: 82F2G7BL4EClass: ACTIBQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
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