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FDA Drug information

Doxorubicin hydrochloride, Liposomal

Read time: 1 mins
Marketing start date: 10 Apr 2025
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Summary of product characteristics


Effective Time

20231219

Version

2

Spl Product Data Elements

doxorubicin hydrochloride, Liposomal doxorubicin hydrochloride doxorubicin hydrochloride doxorubicin SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE hydrogenated soybean lecithin cholesterol ammonium sulfate histidine hydrochloric acid sodium hydroxide sucrose

Brand Name

Doxorubicin hydrochloride, Liposomal

Generic Name

doxorubicin hydrochloride

Product Ndc

0338-9581

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg/10 mL Caelyx ® pegylated liposomal 2 mg/ml sterile concentrate doxorubicin hydrochloride 20 mg/10 mL IV after dilution. Caelyx ® pegylated liposomal 2 mg/ml concentrate for solution for infusion doxorubicin hydrochloride 20 mg/10 mL Intravenous use after dilution . Do not use interchangeably with other formulations of doxorubicin hydrochloride. Cytotoxic 1 vial Baxter Logo One ml of Caelyx pegylated liposomal contains 2 mg doxorubicin hydrochloride. Excipients: α-(2-[1,2-distearoyl- sn- glycero(3) phosphooxy]ethylcarbamoyl) -ϖ-methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide. Keep out of the sight and reach of children. Store in a refrigerator. Do not freeze. Read the package leaflet before use. Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom PLGB 00116/0255 10ml-container-label 10ml-carton-label

Drug section

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