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LABELS · f90b3bb0-87cd-4951-9789-34202e2b13df

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
2025-04-21
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: 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. Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult and pediatric patients with: 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 )
Full extracted label fields
application numbers
  1. NDA210735
boxed warning exact
    brand names
    1. Cyclophosphamide
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c1eb470-0bba-457d-94e3-b9508f0d398a
    generic names
    1. CYCLOPHOSPHAMIDE
    id
    f90b3bb0-87cd-4951-9789-34202e2b13df
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: 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. Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult and pediatric patients with: 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 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Eugia US LLC
      matched search terms
      1. carcinoma
      2. lymphoma
      3. lymphomas
      4. leukemia
      5. myeloma
      6. malignant
      7. neuroblastoma
      8. retinoblastoma
      package ndcs
      1. 55150-270-01
      2. 55150-270-99
      3. 55150-271-01
      4. 55150-271-99
      5. 55150-272-01
      product ndcs
      1. 55150-270
      2. 55150-271
      3. 55150-272
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        1. INTRAVENOUS
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        meta
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        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
        2026-09-09
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        url
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        spl effective date
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        spl effective time
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        substance names
        1. CYCLOPHOSPHAMIDE
        uniis
        1. 8N3DW7272P
        verification flags
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        Drugs@FDA application source records
        1. application number
          NDA210735
          payload
          all indexed label documents
          1. Appl No
            210735
            Application Docs Date
            2023-11-21 00:00:00
            Application Docs ID
            76644
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
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            Submission Type
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          2. 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
            2
            Submission No
            1
            Submission Type
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          all submission records
          1. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2021-08-25 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            210735
            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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            Submission Type
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            Submissions Public Notes
          application number
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          approval interpretation
          Application linkage and approved submission are not indication-level current approval verification
          current indication status
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          has approved submission record
          true
          latest approved submission date
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          latest label selection rule
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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 Type ID
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          Appl No
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          Appl Type
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          Sponsor Name
          EUGIA PHARMA SPECLTS
          openfda application present
          true
          products
          1. Active Ingredient
            CYCLOPHOSPHAMIDE
            Appl No
            210735
            Drug Name
            CYCLOPHOSPHAMIDE
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            500MG/2.5ML (200MG/ML)
            marketing status
            1. Prescription
          2. Active Ingredient
            CYCLOPHOSPHAMIDE
            Appl No
            210735
            Drug Name
            CYCLOPHOSPHAMIDE
            Form
            SOLUTION;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            1GM/5ML (200MG/ML)
            marketing status
            1. Prescription
          3. Active Ingredient
            CYCLOPHOSPHAMIDE
            Appl No
            210735
            Drug Name
            CYCLOPHOSPHAMIDE
            Form
            SOLUTION;INTRAVENOUS
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            2GM/10ML (200MG/ML)
            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
        1. NDA210735
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        1 INDICATIONS AND USAGE Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: 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. Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult and pediatric patients with: Malignant Diseases : malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed
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            1 INDICATIONS AND USAGE Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: 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.
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            ry retinoblastoma carcinoma of the breast Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult and pediatric patients with: 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 )
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                Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult and pediatric patients with: 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 )
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                Preserved source evidence · Not medical advice