cyclophosphamide
cyclophosphamide is listed in the FDA National Drug Code directory with 48 NDC codes, marketed under brand names including Cyclophosphamide, CYCLOPHOSPHAMIDE. Available dosage forms: injection, powder, for solution, injection, solution, powder.
Drug Details
- Generic Name
- cyclophosphamide
- Brand Names
- Cyclophosphamide, CYCLOPHOSPHAMIDE
- Application Number
- ANDA040745
- Sponsor
- Civica, Inc.
- NDC Codes
- 48
- Dosage Forms
- INJECTION, POWDER, FOR SOLUTION, INJECTION, SOLUTION, POWDER
- Routes
- INTRAVENOUS, ORAL
- Active Ingredients
- CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE ANHYDROUS
Indications and Usage
1 INDICATIONS AND USAGE Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult patients with: • malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s lymphoma, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma • multiple myeloma • leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) • mycosis fungoides (advanced disease) • neuroblastoma (disseminated disease) • adenocarcinoma of the ovary • retinoblastoma • carcinoma of the breast Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Limitations of Use This cyclophosphamide product is not indicated for use in pediatric patients due to the to the alcohol and propylene glycol content in this product. If treatment with cyclophosphamide is indicated in a pediatric patient, use a different cyclophosphamide product [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 ), and Description ( 11 )] . Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult patients with: Malignant Diseases: malignant lymphomas: Hodgkin’s lymphoma, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1 ) Limitations of Use This cyclophosphamide product is not indicated for use in pediatric patients due to the alcohol and propylene glycol content in this product. If treatment with cyclophosphamide is indicated in a pediatric patient, use a different cyclophosphamide product. ( 1 )