Doxorubicin Hydrochloride Liposome

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Baxter Oncology GmbH

Labeler

Baxter Healthcare Company

DUNS Number

344276063

Products2

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

Product Details

NDC Product Code

0338-0086

Application Number

NDA050718

Marketing Category

NDA authorized generic (C73605)

Route of Administration

INTRAVENOUS

Effective Date

May 31, 2022

Ingredients

SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINEInactive

Code: 3L6NN8ZZKUClass: IACTQuantity: 3.19 mg in 1 mL

DoxorubicinActive

Code: 82F2G7BL4EClass: ACTIBQuantity: 2 mg in 1 mL

CHOLESTEROLInactive

Code: 97C5T2UQ7JClass: IACTQuantity: 3.19 mg in 1 mL

AMMONIUM SULFATEInactive

Code: SU46BAM238Class: IACTQuantity: 0.6 mg in 1 mL

HYDROGENATED SOYBEAN LECITHINInactive

Code: H1109Z9J4NClass: IACTQuantity: 9.58 mg in 1 mL

HISTIDINEInactive

Code: 4QD397987EClass: IACTQuantity: 1.55 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACTQuantity: 94 mg in 1 mL