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- DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Zydus Lifesciences Limited
DOXORUBICIN HYDROCHLORIDE
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL BluePoint Laboratories
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL BluePoint Laboratories
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL NorthStar RxLLC
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL NorthStar RxLLC
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL Dr. Reddy's Laboratories Inc
- DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Zydus Lifesciences Limited
- DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Zydus Pharmaceuticals USA Inc.
- DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Zydus Pharmaceuticals USA Inc.
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL NorthStar RxLLC
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL Dr. Reddy's Laboratories Inc
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL BluePoint Laboratories
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL Dr. Reddy's Laboratories Inc
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL Dr. Reddy's Laboratories Inc
- Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE 2 mg/mL NorthStar RxLLC
- DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Zydus Lifesciences Limited
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
Drug section
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