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LABELS · e3e444b2-9344-4cc2-b35a-370073a747d4

Frindovyx

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
2026-08-26
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 Malignant Diseases FRINDOVYX 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. FRINDOVYX is an alkylating drug indicated for treatment of adults 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. Frindovyx
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ad8ea65-4c98-487a-9c8d-df778765ec5e
    generic names
    1. CYCLOPHOSPHAMIDE
    id
    e3e444b2-9344-4cc2-b35a-370073a747d4
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Malignant Diseases FRINDOVYX 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. FRINDOVYX is an alkylating drug indicated for treatment of adults 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. 83831-119-01
      2. 83831-120-02
      3. 83831-121-04
      product ndcs
      1. 83831-119
      2. 83831-120
      3. 83831-121
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
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          source batch
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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
          results
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          spl effective date
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          spl effective time
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          1. CYCLOPHOSPHAMIDE
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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
              0
              Application Docs Type ID
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              Submission No
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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
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              Application Docs Type ID
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              Submission No
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              Submission Type
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            3. 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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              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
              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
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              Submission Status
              AP
              Submission Status Date
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              Submission Type
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              Submissions Public Notes
            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
              AP
              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
            not_reconciled
            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 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
            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
              1. Prescription
            3. Active Ingredient
              CYCLOPHOSPHAMIDE
              Appl No
              210852
              Drug Name
              FRINDOVYX
              Form
              SOLUTION;INTRAVENOUS
              Product No
              003
              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
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          1 INDICATIONS AND USAGE Malignant Diseases FRINDOVYX 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. FRINDOVYX is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases : malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymph
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            ignant Diseases FRINDOVYX is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages II
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              1 INDICATIONS AND USAGE Malignant Diseases FRINDOVYX 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. FRINDOVYX is an alkylating drug indicated for treatment of adults 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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                  FRINDOVYX is an alkylating drug indicated for treatment of adults 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