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LABELS · 4b1ada65-9911-eacf-e063-6394a90af9d9

CAMCEVI

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
2026-02-18
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 CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
Full extracted label fields
application numbers
  1. NDA211488
boxed warning exact
    brand names
    1. CAMCEVI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7a8761a-d953-413a-e053-2a95a90a60ee
    generic names
    1. LEUPROLIDE
    id
    4b1ada65-9911-eacf-e063-6394a90af9d9
    indications and usage exact
    1. 1 INDICATIONS AND USAGE CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Accord BioPharma, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 69448-014-63
      product ndcs
      1. 69448-014
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.2 ) 02/2025 Warnings and Precautions ( 5.6 ) 09/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 2595044
      2. 2595049
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00300.json
      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
      limit
      100
      skip
      300
      total
      830
      sha256
      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=300&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%224b1ada65-9911-eacf-e063-6394a90af9d9%22
      spl effective date
      2026-02-18
      spl effective time
      20260218
      spl set id
      d7a8761a-d953-413a-e053-2a95a90a60ee
      spl version
      9
      substance names
      1. LEUPROLIDE MESYLATE
      uniis
      1. 8E3C3C493W
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        NDA211488
        payload
        all indexed label documents
        1. Appl No
          211488
          Application Docs Date
          2021-06-02 00:00:00
          Application Docs ID
          67654
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          211488
          Application Docs Date
          2024-03-14 00:00:00
          Application Docs ID
          77827
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          211488
          Application Docs Date
          2025-02-14 00:00:00
          Application Docs ID
          81247
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        4. Appl No
          211488
          Application Docs Date
          2025-09-25 00:00:00
          Application Docs ID
          83474
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        5. Appl No
          211488
          Application Docs Date
          2026-02-13 00:00:00
          Application Docs ID
          85048
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          211488
          Review Priority
          STANDARD
          Submission Class Code ID
          9
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2021-05-25 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          211488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2024-03-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          211488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2025-02-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          211488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2025-09-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          211488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2026-02-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA211488
        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
        2026-02-11
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          211488
          Application Docs Date
          2026-02-13 00:00:00
          Application Docs ID
          85048
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        official application record
        Appl No
        211488
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ACCORD
        openfda application present
        true
        products
        1. Active Ingredient
          LEUPROLIDE MESYLATE
          Appl No
          211488
          Drug Name
          CAMCEVI KIT
          Form
          EMULSION;SUBCUTANEOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 42MG BASE
          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. NDA211488
      brand names
      1. CAMCEVI
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      247
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
      label id
      4b1ada65-9911-eacf-e063-6394a90af9d9
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-40e8707ff890c01e7ed3
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. LEUPROLIDE
      id
      ind-span-78b4cec435648ce22d46
      label id
      4b1ada65-9911-eacf-e063-6394a90af9d9
      positive predicate support span
      end
      44
      end exclusive
      true
      exact text
      is indicated
      label id
      4b1ada65-9911-eacf-e063-6394a90af9d9
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
      start
      32
      qualifier mentions
      1. context exact
        CATIONS AND USAGE CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
        kind
        age
        polarity
        not_inferred
        span
        end
        80
        end exclusive
        true
        exact text
        adult patients
        label id
        4b1ada65-9911-eacf-e063-6394a90af9d9
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
        start
        66
      2. context exact
        MCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        110
        end exclusive
        true
        exact text
        advanced prostate cancer
        label id
        4b1ada65-9911-eacf-e063-6394a90af9d9
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
        start
        86
      regulatory links
        schema version
        0.1.0
        source batch sha256
        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
        source defined aliases
          source span
          end
          111
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
          label id
          4b1ada65-9911-eacf-e063-6394a90af9d9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%224b1ada65-9911-eacf-e063-6394a90af9d9%22
          spl effective date
          2026-02-18
          spl set id
          d7a8761a-d953-413a-e053-2a95a90a60ee
          spl version
          9
          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
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA211488
          brand names
          1. CAMCEVI
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          247
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
          label id
          4b1ada65-9911-eacf-e063-6394a90af9d9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-838f71897d7df8edd545
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. LEUPROLIDE
          id
          ind-span-b2a39907ee385e1765e6
          label id
          4b1ada65-9911-eacf-e063-6394a90af9d9
          positive predicate support span
          end
          180
          end exclusive
          true
          exact text
          is a gonadotropin-releasing hormone (GnRH) agonist indicated
          label id
          4b1ada65-9911-eacf-e063-6394a90af9d9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
          start
          120
          qualifier mentions
          1. context exact
            asing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
            kind
            age
            polarity
            not_inferred
            span
            end
            216
            end exclusive
            true
            exact text
            adult patients
            label id
            4b1ada65-9911-eacf-e063-6394a90af9d9
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
            start
            202
          2. context exact
            agonist indicated for the treatment of adult patients with advanced prostate cancer.
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            246
            end exclusive
            true
            exact text
            advanced prostate cancer
            label id
            4b1ada65-9911-eacf-e063-6394a90af9d9
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
            start
            222
          regulatory links
            schema version
            0.1.0
            source batch sha256
            bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
            source defined aliases
              source span
              end
              247
              end exclusive
              true
              exact text
              CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
              label id
              4b1ada65-9911-eacf-e063-6394a90af9d9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              163359db8cc995fe73bd0bea647b4fac94d6092dfeb1baf834ef1dcddb9b8fb6
              start
              112
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%224b1ada65-9911-eacf-e063-6394a90af9d9%22
              spl effective date
              2026-02-18
              spl set id
              d7a8761a-d953-413a-e053-2a95a90a60ee
              spl version
              9
              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
              tumor_directed_candidate

              Preserved source evidence · Not medical advice