Doxorubicin
Drug Details
- Generic Name
- Doxorubicin
- Brand Names
- Doxorubicin Hydrochloride
- Application Number
- ANDA208888
- Sponsor
- Amneal Pharmaceuticals LLC
- NDC Codes
- 2
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER
- Routes
- INTRAVENOUS
- Active Ingredients
- DOXORUBICIN HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Doxorubicin 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 HCl for 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 )]. 1.2 Other Cancers Doxorubicin 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