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LABELS · 35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4

Cyclophosphamide

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2024-11-19
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Cyclophosphamide 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 in pediatric 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 Capsules are 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 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 Capsules, 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 Capsules are indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. Limitations of Use: The safety and effectiveness of Cyclophosphamide Capsules for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
Full extracted label fields
application numbers
  1. NDA203856
boxed warning exact
    brand names
    1. Cyclophosphamide
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8135b917-882f-4b4c-99b7-fa8ea54af4bf
    generic names
    1. CYCLOPHOSPHAMIDE
    id
    35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Cyclophosphamide 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 in pediatric 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 Capsules are 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 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 Capsules, 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 Capsules are indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. Limitations of Use: The safety and effectiveness of Cyclophosphamide Capsules for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Hikma Pharmaceuticals USA Inc.
      matched search terms
      1. carcinoma
      2. lymphoma
      3. lymphomas
      4. leukemia
      5. myeloma
      6. malignant
      7. neuroblastoma
      8. retinoblastoma
      package ndcs
      1. 0054-0382-13
      2. 0054-0382-25
      3. 0054-0383-13
      4. 0054-0383-25
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      1. 0054-0382
      2. 0054-0383
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      1. HUMAN PRESCRIPTION DRUG
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        last updated
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        1. CYCLOPHOSPHAMIDE
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        1. application number
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          1. Appl No
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            Application Docs Date
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            Application Docs ID
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            Submission No
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          2. Appl No
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          products
          1. Active Ingredient
            CYCLOPHOSPHAMIDE
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            Drug Name
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            CAPSULE;ORAL
            Product No
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            Reference Drug
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            Reference Standard
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            marketing status
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          2. Active Ingredient
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            Appl No
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            Drug Name
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            Form
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            Product No
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            Reference Drug
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            Reference Standard
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            Strength
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            marketing status
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        Source passages and status connections

        Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

        Passage 1 · positive indication candidate
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        1 INDICATIONS AND USAGE Cyclophosphamide 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
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        is an alkylating drug indicated
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          1 INDICATIONS AND USAGE Cyclophosphamide is an alkylating drug indicated for treatment of:
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            1 INDICATIONS AND USAGE Cyclophosphamide is an alkylating drug indicated for treatment of:
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            1 INDICATIONS AND USAGE Cyclophosphamide 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 in pediatric patients who failed to adequately respond to or are unable to tolerate adrenoc
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                • 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 )
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                a, 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 in pediatric 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 Capsules are indicated for the treatment of: • malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma
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                    • Minimal Change Nephrotic Syndrome in Pediatric Patients : biopsy proven minimal change nephrotic syndrome in pediatric 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.
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                    le 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 Capsules are 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 lymp
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