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LABELS · 81f6f0e0-48f4-4eb1-95e5-b1463e5f53f5

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
2025-03-11
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 Cyclophosphamide 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. ( 1.1 ) 1.1 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.
Full extracted label fields
application numbers
  1. NDA212501
boxed warning exact
    brand names
    1. CYCLOPHOSPHAMIDE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5818647-d840-e9d7-c7b8-6541b485e44e
    generic names
    1. CYCLOPHOSPHAMIDE
    id
    81f6f0e0-48f4-4eb1-95e5-b1463e5f53f5
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Cyclophosphamide 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. ( 1.1 ) 1.1 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.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Dr. Reddy's Labratories Inc.
      matched search terms
      1. carcinoma
      2. lymphoma
      3. lymphomas
      4. leukemia
      5. myeloma
      6. malignant
      7. neuroblastoma
      8. retinoblastoma
      package ndcs
      1. 75907-191-02
      2. 75907-190-07
      3. 75907-189-35
      product ndcs
      1. 75907-189
      2. 75907-191
      3. 75907-190
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. RECENT MAJOR CHANGES Dosage and Administration ( 2.2; 2.3 ) 03/2025 Warnings and Precautions, Embryo Fetal Toxicity ( 5.8 ) 03/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2386859
      source batch
      file
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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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      limit
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      830
      sha256
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      url
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      source url
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      spl effective date
      2025-03-11
      spl effective time
      20250311
      spl set id
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      spl version
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      substance names
      1. CYCLOPHOSPHAMIDE ANHYDROUS
      uniis
      1. 6UXW23996M
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      Drugs@FDA application source records
      1. application number
        NDA212501
        payload
        all indexed label documents
        1. Appl No
          212501
          Application Docs Date
          2020-08-05 00:00:00
          Application Docs ID
          64180
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          212501
          Application Docs Date
          2021-09-10 00:00:00
          Application Docs ID
          68573
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          212501
          Application Docs Date
          2024-07-01 00:00:00
          Application Docs ID
          78939
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
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        4. Appl No
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          Application Docs Date
          2025-03-14 00:00:00
          Application Docs ID
          81573
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          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
          2020-07-30 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          212501
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2021-09-09 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          212501
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2021-11-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          212501
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2025-03-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA212501
        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
          212501
          Application Docs Date
          2025-03-14 00:00:00
          Application Docs ID
          81573
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        DR REDDYS
        openfda application present
        true
        products
        1. Active Ingredient
          CYCLOPHOSPHAMIDE
          Appl No
          212501
          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
          212501
          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
          212501
          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
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      brand names
      1. CYCLOPHOSPHAMIDE
      classification reasons
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      true
      exact text
      1 INDICATIONS AND USAGE Cyclophosphamide 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. ( 1.1 ) 1.1 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),
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      1. CYCLOPHOSPHAMIDE
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      is an alkylating drug indicated
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      qualifier mentions
      1. context exact
        hosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant
        kind
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        not_inferred
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      2. context exact
        is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant lymphomas: Hodgkin's di
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      3. context exact
        1 INDICATIONS AND USAGE Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: mali
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        biomarker
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        not_inferred
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        alkylating drug indicated for treatment of
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      4. context exact
        mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma.
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        true
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        retinoblastoma
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      regulatory links
        schema version
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          1 INDICATIONS AND USAGE Cyclophosphamide 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.
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          spl effective date
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          Source null
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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. ( 1.1 ) 1.1 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
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                , mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1.1 ) 1.1 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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                3. context exact
                  blastoma (disseminated disease) adenocarcinoma of the ovary retinoblastoma carcinoma of the breast Cyclophosphamide, although effective alone in susceptible malign
                  kind
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                    1.1 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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                    Preserved source evidence · Not medical advice