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FDA Drug information

DOXORUBICIN HYDROCHLORIDE

Read time: 1 mins
Marketing start date: 24 Jul 2024

Summary of product characteristics


Effective Time

20221101

Version

2

Spl Product Data Elements

DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride DOXORUBICIN HYDROCHLORIDE DOXORUBICIN N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT HYDROGENATED SOYBEAN LECITHIN CHOLESTEROL AMMONIUM SULFATE SUCROSE HISTIDINE HYDROCHLORIC ACID SODIUM HYDROXIDE DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride DOXORUBICIN HYDROCHLORIDE DOXORUBICIN N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT HYDROGENATED SOYBEAN LECITHIN CHOLESTEROL AMMONIUM SULFATE SUCROSE HISTIDINE HYDROCHLORIC ACID SODIUM HYDROXIDE

Application Number

ANDA212299

Brand Name

DOXORUBICIN HYDROCHLORIDE

Generic Name

doxorubicin hydrochloride

Product Ndc

49315-008

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20 mg/10 mL Container Label NDC 49315- 008 -03 DOXOrubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) Cytotoxic Agent Must be diluted LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL FOR INTRAVENOUS INFUSION ONLY 10 mL Single-Dose Vial Rx only 20 mg/10 mL Carton Label NDC 49315- 008 -03 DOXOrubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) Cytotoxic Agent Must be diluted LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL FOR INTRAVENOUS INFUSION ONLY Sterile Refrigerate at 2⁰ to 8℃ (36⁰ to 46℉) Do not freeze 10 mL Single-Dose Vial Rx only 50 mg/25 mL Container Label NDC 49315-009-07 DOXOrubicin Hydrochloride Liposome Injection 50 mg/25 mL (2 mg/mL) Cytotoxic Agent Must be diluted LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL FOR INTRAVENOUS INFUSION ONLY 25 mL Single-Dose Vial Rx only 50 mg/25 mL Carton Label NDC 49315-009-07 DOXOrubicin Hydrochloride Liposome Injection 50 mg/25 mL (2 mg/mL) Cytotoxic Agent Must be diluted LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL FOR INTRAVENOUS INFUSION ONLY Sterile Refrigerate at 2⁰ to 8℃ (36⁰ to 46℉) Do not freeze 25 mL Single-Dose Vial Rx only 20 mg/10mL vial label 20 mg/10 mL carton label 50 mg/25mL vial label 50 mg/25 mL carton label

Spl Unclassified Section

SPL UNCLASSIFIED

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