Application Nr Approved Date Route Status External Links
ANDA091495 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Doxorubicin Hydrochloride (hcl) Injection Is An Anthracycline Topoisomerase Ii Inhibitor Indicated: As A Component Of Multiagent Adjuvant Chemotherapy For Treatment Of Women With Axillary Lymph Node Involvement Following Resection Of Primary Breast Cancer ( 1.1 ). For The Treatment Of: Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Metastatic Breast Cancer, Metastatic Wilms' Tumor, Metastatic Neuroblastoma, Metastatic Soft Tissue Sarcoma, Metastatic Bone Sarcomas, Metastatic Ovarian Carcinoma, Metastatic Transitional Cell Bladder Carcinoma, Metastatic Thyroid Carcinoma, Metastatic Gastric Carcinoma, Metastatic Bronchogenic Carcinoma ( 1.2 ). 1.1 Adjuvant Breast Cancer Doxorubicin Hydrochloride Injection, Usp Is Indicated As A Component Of Multi-Agent Adjuvant Chemotherapy For Treatment Of Women With Axillary Lymph Node Involvement Following Resection Of Primary Breast Cancer [see Clinical Studies ( 14 )]. 1.2 Other Cancers Doxorubicin Hydrochloride Injection, Usp Is Indicated For The Treatment Of Acute Lymphoblastic Leukemia Acute Myeloblastic Leukemia Hodgkin Lymphoma Non-Hodgkin Lymphoma (nhl) Metastatic Breast Cancer Metastatic Wilms' Tumor Metastatic Neuroblastoma Metastatic Soft Tissue Sarcoma Metastatic Bone Sarcoma Metastatic Ovarian Carcinoma Metastatic Transitional Cell Bladder Carcinoma Metastatic Thyroid Carcinoma Metastatic Gastric Carcinoma Metastatic Bronchogenic Carcinoma

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE ZINC3918087

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