Application Nr Approved Date Route Status External Links
ANDA210046 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Cyclophosphamide For Injection Is An Alkylating Drug Indicated For Treatment Of: Malignant Diseases: Malignant Lymphomas: Hodgkin's Disease, Lymphocytic Lymphoma, Mixed-Cell Type Lymphoma, Histiocytic Lymphoma, Burkitt's Lymphoma; Multiple Myeloma, Leukemias, Mycosis Fungoides, Neuroblastoma, Adenocarcinoma Of Ovary, Retinoblastoma, Breast Carcinoma. ( 1.1 ) Minimal Change Nephrotic Syndrome In Pediatric Patients: Biopsy Proven Minimal Change Nephrotic Syndrome Patients Who Failed To Adequately Respond To Or Are Unable To Tolerate Adrenocorticosteroid Therapy. ( 1.2 ) Limitations Of Use: The Safety And Effectiveness For The Treatment Of Nephrotic Syndrome In Adults Or Other Renal Disease Has Not Been Established. 1.1 Malignant Diseases Cyclophosphamide For Injection Is Indicated For The Treatment Of: Malignant Lymphomas (Stages Iii And Iv Of The Ann Arbor Staging System), Hodgkin’s Disease, 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 For Injection 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 For Injection, Although Effective Alone In Susceptible Malignancies, Is More Frequently Used Concurrently Or Sequentially With Other Antineoplastic Drugs. 1.2 Minimal Change Nephrotic Syndrome In Pediatric Patients Cyclophosphamide For Injection Is Indicated For The Treatment Of Biopsy Proven Minimal Change Nephrotic Syndrome In Pediatrics Patients Who Failed To Adequately Respond To Or Are Unable To Tolerate Adrenocorticosteroid Therapy. Limitations Of Use: The Safety And Effectiveness For The Treatment Of Nephrotic Syndrome In Adults Or Other Renal Disease Has Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cyclophosphamide CYCLOPHOSPHAMIDE ZINC100008275

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