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LABELS · 5fc45658-c2d9-41de-821f-ff6f40a469dd

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
2024-07-26
Captured
2026-09-09T23:37:51.659493+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 Injection, 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. NDA210852
boxed warning exact
    brand names
    1. Cyclophosphamide
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f593585-e0dd-48bc-bd2b-c6c787e0b98c
    generic names
    1. CYCLOPHOSPHAMIDE
    id
    5fc45658-c2d9-41de-821f-ff6f40a469dd
    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 Injection, 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. Avyxa Pharma, LLC
      matched search terms
      1. carcinoma
      2. lymphoma
      3. lymphomas
      4. leukemia
      5. myeloma
      6. malignant
      7. neuroblastoma
      8. retinoblastoma
      package ndcs
      1. 83831-116-01
      2. 83831-117-02
      3. 83831-118-04
      product ndcs
      1. 83831-116
      2. 83831-117
      3. 83831-118
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
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        routes
        1. INTRAVENOUS
        rxcuis
        1. 2644738
        2. 2644751
        3. 2644824
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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
        2026-09-09
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        substance names
        1. CYCLOPHOSPHAMIDE
        uniis
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        Drugs@FDA application source records
        1. application number
          NDA210852
          payload
          all indexed label documents
          1. Appl No
            210852
            Application Docs Date
            2023-06-09 00:00:00
            Application Docs ID
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            Application Docs Title
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            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
            2025-02-05 00:00:00
            Application Docs ID
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            Application Docs Title
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            Application Docs Type ID
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            Submission No
            5
            Submission Type
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          3. Appl No
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            Application Docs Date
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            Application Docs ID
            83035
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            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
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          all submission records
          1. Appl No
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            STANDARD
            Submission Class Code ID
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            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2023-06-07 00:00:00
            Submission Type
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            Submissions Public Notes
          2. Appl No
            210852
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2025-01-24 00:00:00
            Submission Type
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            Submissions Public Notes
          3. Appl No
            210852
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
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            Submission Status
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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
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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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          official application record
          Appl No
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          Appl Public Notes
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          Sponsor Name
          AVYXA HOLDINGS
          openfda application present
          true
          products
          1. Active Ingredient
            CYCLOPHOSPHAMIDE
            Appl No
            210852
            Drug Name
            FRINDOVYX
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            500MG/ML (500MG/ML)
            marketing status
            1. Prescription
          2. Active Ingredient
            CYCLOPHOSPHAMIDE
            Appl No
            210852
            Drug Name
            FRINDOVYX
            Form
            SOLUTION;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            1GM/2ML (500MG/ML)
            marketing status
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          3. Active Ingredient
            CYCLOPHOSPHAMIDE
            Appl No
            210852
            Drug Name
            FRINDOVYX
            Form
            SOLUTION;INTRAVENOUS
            Product No
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            Reference Drug
            1
            Reference Standard
            1
            Strength
            2GM/4ML (500MG/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
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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 Injection, 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 Injection, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
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            lastoma carcinoma of the breast Cyclophosphamide Injection, 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.
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                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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                ce5bde6210ad2da158d61f238784d40c0a383ceb138c6d4d6cb86c29ba1b3a35
                start
                1139
                current approval status
                not_reconciled
                duplicate text group
                dup-a81e64ec271935601f34
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. CYCLOPHOSPHAMIDE
                id
                ind-span-d3a815067189c36e0672
                label id
                5fc45658-c2d9-41de-821f-ff6f40a469dd
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                    source defined aliases
                      source span
                      end
                      1344
                      end exclusive
                      true
                      exact text
                      ( 1 )
                      label id
                      5fc45658-c2d9-41de-821f-ff6f40a469dd
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      ce5bde6210ad2da158d61f238784d40c0a383ceb138c6d4d6cb86c29ba1b3a35
                      start
                      1339
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%225fc45658-c2d9-41de-821f-ff6f40a469dd%22
                      spl effective date
                      2024-07-26
                      spl set id
                      6f593585-e0dd-48bc-bd2b-c6c787e0b98c
                      spl version
                      3
                      structured fields status
                      not_extracted_no_values_inferred_from_mentions
                      structured indication
                      age
                      Source null
                      approval pathway
                      Source null
                      biomarker and test
                      Source null
                      disease stage
                      Source null
                      limitations
                      Source null
                      line
                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
                      unclear

                      Preserved source evidence · Not medical advice