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LABELS · dc40762e-5ccf-402c-a7b1-4c9dee737811

Cyclophosphamide

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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
2020-08-07
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Cyclophosphamide Tablets 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. ( 1.2 ) 1.1 Malignant Diseases Cyclophosphamide Tablets 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 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. 1.2 Minimal Change Nephrotic Syndrome in Pediatric Patients: Cyclophosphamide Tablets is 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 Tablets for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
Full extracted label fields
application numbers
  1. NDA012141
boxed warning exact
    brand names
    1. Cyclophosphamide
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=769ded74-6186-40a8-8e44-ceff67287451
    generic names
    1. CYCLOPHOSPHAMIDE
    id
    dc40762e-5ccf-402c-a7b1-4c9dee737811
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Cyclophosphamide Tablets 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. ( 1.2 ) 1.1 Malignant Diseases Cyclophosphamide Tablets 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 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. 1.2 Minimal Change Nephrotic Syndrome in Pediatric Patients: Cyclophosphamide Tablets is 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 Tablets 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. Baxter Healthcare Corporation
      matched search terms
      1. carcinoma
      2. lymphoma
      3. lymphomas
      4. leukemia
      5. myeloma
      6. malignant
      7. neuroblastoma
      8. retinoblastoma
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      2. 10019-982-01
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      4. 10019-984-01
      product ndcs
      1. 10019-982
      2. 10019-984
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration, Hydration and Important Administration Instructions ( 2.1 ) 08/2020 Warnings and Precautions, Embryo Fetal Toxicity (5.7) 08/2020
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      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
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      spl effective date
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      spl effective time
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      substance names
      1. CYCLOPHOSPHAMIDE
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      1. application number
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        payload
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        1. Appl No
          012141
          Application Docs Date
          2012-04-02 00:00:00
          Application Docs ID
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          Submission No
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          Application Docs ID
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          Submission No
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          Submission Status Date
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        2. Appl No
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          Review Priority
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        3. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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        4. Appl No
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          Review Priority
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          Submission Class Code ID
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          Submission No
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          Submissions Public Notes
        5. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        6. Appl No
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          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
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          Submission Status Date
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          Submissions Public Notes
        7. Appl No
          012141
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          84
          Submission Status
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          Submission Status Date
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          Submissions Public Notes
        8. Appl No
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          Review Priority
          STANDARD
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          Submission No
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        9. Appl No
          012141
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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        10. Appl No
          012141
          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
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          Submissions Public Notes
        11. Appl No
          012141
          Review Priority
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        12. Appl No
          012141
          Review Priority
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        application number
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        approval interpretation
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        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
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        latest posted label documents
        1. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
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        Sponsor Name
        BAXTER HLTHCARE
        openfda application present
        true
        products
        1. Active Ingredient
          CYCLOPHOSPHAMIDE
          Appl No
          012141
          Drug Name
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          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          50MG
          marketing status
          1. Prescription
        2. Active Ingredient
          CYCLOPHOSPHAMIDE
          Appl No
          012141
          Drug Name
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          Form
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          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          25MG
          marketing status
          1. Prescription

      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
      application numbers
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      1 INDICATIONS AND USAGE Cyclophosphamide Tablets 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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        1 INDICATIONS AND USAGE Cyclophosphamide Tablets is an alkylating drug indicated for treatment of:
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          1 INDICATIONS AND USAGE Cyclophosphamide Tablets is an alkylating drug indicated for treatment of:
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          1 INDICATIONS AND USAGE Cyclophosphamide Tablets 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
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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 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. ( 1.2 ) 1.1 Malignant Diseases Cyclophosphamide Tablets is indicated for the treatment of: • malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic ly
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                                                                                  Preserved source evidence · Not medical advice