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LABELS · 5c81399c-bacb-48ec-8985-836412a07a6d

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
2024-04-10
Captured
2026-09-09T23:37:47.659725+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. NDA217651
boxed warning exact
    brand names
    1. Cyclophosphamide
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34dbffee-80e0-49c3-90e8-95713a0b7fbe
    generic names
    1. CYCLOPHOSPHAMIDE INJECTION, SOLUTION
    id
    5c81399c-bacb-48ec-8985-836412a07a6d
    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. Baxter Healthcare Company
      matched search terms
      1. carcinoma
      2. lymphoma
      3. lymphomas
      4. leukemia
      5. myeloma
      6. malignant
      7. neuroblastoma
      8. retinoblastoma
      package ndcs
      1. 0338-9777-01
      2. 0338-9779-01
      product ndcs
      1. 0338-9777
      2. 0338-9779
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        1. INTRAVENOUS
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        1. 2386859
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        last updated
        2026-09-09
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        1. CYCLOPHOSPHAMIDE
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        Drugs@FDA application source records
        1. application number
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          payload
          all indexed label documents
          1. Appl No
            217651
            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
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            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
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          1. Appl No
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          products
          1. Active Ingredient
            CYCLOPHOSPHAMIDE
            Appl No
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            Drug Name
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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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          2. Active Ingredient
            CYCLOPHOSPHAMIDE
            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.

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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 lymp
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            1 INDICATIONS AND USAGE Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with:
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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 lympho
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                  • 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
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                  lignant 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)
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                        • multiple myeloma
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                        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 su
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                              • 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)
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                              ffective 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 frequen
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                                                            5c81399c-bacb-48ec-8985-836412a07a6d
                                                            positive predicate support span
                                                            Source null
                                                            qualifier mentions
                                                            1. context exact
                                                              mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma.
                                                              kind
                                                              biomarker
                                                              polarity
                                                              not_inferred
                                                              span
                                                              end
                                                              1328
                                                              end exclusive
                                                              true
                                                              exact text
                                                              retinoblastoma
                                                              label id
                                                              5c81399c-bacb-48ec-8985-836412a07a6d
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              eb2aadaeebded15b033b57e0090b14703b63b2eaeb12c7bd7d2a3f02654c82c7
                                                              start
                                                              1314
                                                            regulatory links
                                                              schema version
                                                              0.1.0
                                                              source batch sha256
                                                              bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                              source defined aliases
                                                                source span
                                                                end
                                                                1347
                                                                end exclusive
                                                                true
                                                                exact text
                                                                • 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.
                                                                label id
                                                                5c81399c-bacb-48ec-8985-836412a07a6d
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
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                                                                source text sha256
                                                                eb2aadaeebded15b033b57e0090b14703b63b2eaeb12c7bd7d2a3f02654c82c7
                                                                start
                                                                1073
                                                                source url
                                                                https://api.fda.gov/drug/label.json?search=id%3A%225c81399c-bacb-48ec-8985-836412a07a6d%22
                                                                spl effective date
                                                                2024-04-10
                                                                spl set id
                                                                34dbffee-80e0-49c3-90e8-95713a0b7fbe
                                                                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
                                                                Passage 12 · unclassified context
                                                                application numbers
                                                                1. NDA217651
                                                                brand names
                                                                1. Cyclophosphamide
                                                                classification reasons
                                                                1. no_unambiguous_positive_indication_predicate
                                                                clinical review status
                                                                pending
                                                                content role
                                                                unclassified_context
                                                                context span
                                                                end
                                                                1353
                                                                end exclusive
                                                                true
                                                                exact text
                                                                lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1 )
                                                                label id
                                                                5c81399c-bacb-48ec-8985-836412a07a6d
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                                                                source field
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                                                                source text sha256
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                                                                start
                                                                1148
                                                                current approval status
                                                                not_reconciled
                                                                duplicate text group
                                                                dup-3819827c640cb641f9bd
                                                                extraction review status
                                                                automated_candidate_pending_source_review
                                                                generic names
                                                                1. CYCLOPHOSPHAMIDE INJECTION, SOLUTION
                                                                id
                                                                ind-span-7f36914503e7e6f3f4d7
                                                                label id
                                                                5c81399c-bacb-48ec-8985-836412a07a6d
                                                                positive predicate support span
                                                                Source null
                                                                qualifier mentions
                                                                  regulatory links
                                                                    schema version
                                                                    0.1.0
                                                                    source batch sha256
                                                                    bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                    source defined aliases
                                                                      source span
                                                                      end
                                                                      1353
                                                                      end exclusive
                                                                      true
                                                                      exact text
                                                                      ( 1 )
                                                                      label id
                                                                      5c81399c-bacb-48ec-8985-836412a07a6d
                                                                      offset unit
                                                                      unicode_code_points
                                                                      source array index
                                                                      0
                                                                      source field
                                                                      indications_and_usage_exact
                                                                      source text sha256
                                                                      eb2aadaeebded15b033b57e0090b14703b63b2eaeb12c7bd7d2a3f02654c82c7
                                                                      start
                                                                      1348
                                                                      source url
                                                                      https://api.fda.gov/drug/label.json?search=id%3A%225c81399c-bacb-48ec-8985-836412a07a6d%22
                                                                      spl effective date
                                                                      2024-04-10
                                                                      spl set id
                                                                      34dbffee-80e0-49c3-90e8-95713a0b7fbe
                                                                      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