Application Nr Approved Date Route Status External Links
ANDA091418 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) 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 C Omponent Of Multi-A Gent Adjuvant Chemotherapy For Treat Ment Of Wo Men With Axillary Lymph Node Involve Ment Following Resection Of Pri Mary Breast Cancer [See Clinical Studies (14.1 ) ]. 1.2 Other Cancers Doxorubicin Hydrochloride Injection, Usp Is Indicated For The Treat Ment Of Acute Ly Mphoblastic Leu Ke Mia Acute M Yeloblastic Leuke Mia Hodgkin Lympho Ma Non-Hodgkin Ly Mpho Ma (Nhl) Metastatic Breast Cancer Metastatic Wil Ms’ Tumor Metastatic Neurobla Stoma Metastatic S Oft Tissue Sa Rco Ma Metastatic Bone Sarco Ma Metastatic O Varian Car Cino Ma Metastatic T Ransitional C Ell Bladder Carcino Ma Metastatic T Hyroid 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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