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LABELS · 5a3f7aed-1747-4c52-9e10-5aa090dd088e

LEUKERAN

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
2025-01-08
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS).

Indications and usage: exact source text

  1. INDICATIONS AND USAGE LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.
Full extracted label fields
application numbers
  1. NDA010669
boxed warning exact
  1. WARNING LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS).
brand names
  1. LEUKERAN
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=58a3c995-5ad6-465d-8437-5970c9088213
generic names
  1. CHLORAMBUCIL
id
5a3f7aed-1747-4c52-9e10-5aa090dd088e
indications and usage exact
  1. INDICATIONS AND USAGE LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Waylis Therapeutics LLC
    matched search terms
    1. lymphoma
    2. lymphomas
    3. leukemia
    4. malignant
    package ndcs
    1. 80725-610-25
    product ndcs
    1. 80725-610
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 105553
      2. 197462
      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%225a3f7aed-1747-4c52-9e10-5aa090dd088e%22
      spl effective date
      2025-01-08
      spl effective time
      20250108
      spl set id
      58a3c995-5ad6-465d-8437-5970c9088213
      spl version
      2
      substance names
      1. CHLORAMBUCIL
      uniis
      1. 18D0SL7309
      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
        NDA010669
        payload
        all indexed label documents
        1. Appl No
          010669
          Application Docs Date
          2003-12-02 00:00:00
          Application Docs ID
          10754
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          28
          Submission Type
          SUPPL
        2. Appl No
          010669
          Application Docs Date
          2010-05-03 00:00:00
          Application Docs ID
          33024
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          30
          Submission Type
          SUPPL
        3. Appl No
          010669
          Application Docs Date
          2011-11-01 00:00:00
          Application Docs ID
          33025
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          010669
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2011-10-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          010669
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          30
          Submission Status
          AP
          Submission Status Date
          2010-04-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          010669
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2005-05-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          010669
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          28
          Submission Status
          AP
          Submission Status Date
          2003-11-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          010669
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          25
          Submission Status
          AP
          Submission Status Date
          2002-11-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          010669
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2001-06-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          010669
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2001-07-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          010669
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          22
          Submission Status
          AP
          Submission Status Date
          2001-07-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          010669
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2001-07-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          010669
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          1995-06-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          010669
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          1994-02-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          010669
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          1996-02-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA010669
        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
        2011-10-28
        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
          010669
          Application Docs Date
          2011-11-01 00:00:00
          Application Docs ID
          33025
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        official application record
        Appl No
        010669
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        WAYLIS THERAP
        openfda application present
        true
        products
        1. Active Ingredient
          CHLORAMBUCIL
          Appl No
          010669
          Drug Name
          LEUKERAN
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          2MG
          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. NDA010669
      brand names
      1. LEUKERAN
      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
      306
      end exclusive
      true
      exact text
      INDICATIONS AND USAGE LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.
      label id
      5a3f7aed-1747-4c52-9e10-5aa090dd088e
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      dd6be9338da0c5522b42bf2ab8d9e7b47ba3e8bac2377c8c125bb74a3108cf67
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-22e8b49329d78da58fe2
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. CHLORAMBUCIL
      id
      ind-span-9abdd1eba136dc80b75a
      label id
      5a3f7aed-1747-4c52-9e10-5aa090dd088e
      positive predicate support span
      end
      58
      end exclusive
      true
      exact text
      is indicated
      label id
      5a3f7aed-1747-4c52-9e10-5aa090dd088e
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      dd6be9338da0c5522b42bf2ab8d9e7b47ba3e8bac2377c8c125bb74a3108cf67
      start
      46
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
          source defined aliases
            source span
            end
            215
            end exclusive
            true
            exact text
            INDICATIONS AND USAGE LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease.
            label id
            5a3f7aed-1747-4c52-9e10-5aa090dd088e
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            dd6be9338da0c5522b42bf2ab8d9e7b47ba3e8bac2377c8c125bb74a3108cf67
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%225a3f7aed-1747-4c52-9e10-5aa090dd088e%22
            spl effective date
            2025-01-08
            spl set id
            58a3c995-5ad6-465d-8437-5970c9088213
            spl version
            2
            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 · unclassified context
            application numbers
            1. NDA010669
            brand names
            1. LEUKERAN
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            306
            end exclusive
            true
            exact text
            USAGE LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.
            label id
            5a3f7aed-1747-4c52-9e10-5aa090dd088e
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            dd6be9338da0c5522b42bf2ab8d9e7b47ba3e8bac2377c8c125bb74a3108cf67
            start
            16
            current approval status
            not_reconciled
            duplicate text group
            dup-ff18ad02d683c176b127
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. CHLORAMBUCIL
            id
            ind-span-ce4488128cb540349fb9
            label id
            5a3f7aed-1747-4c52-9e10-5aa090dd088e
            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
                  306
                  end exclusive
                  true
                  exact text
                  It is not curative in any of these disorders but may produce clinically useful palliation.
                  label id
                  5a3f7aed-1747-4c52-9e10-5aa090dd088e
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  dd6be9338da0c5522b42bf2ab8d9e7b47ba3e8bac2377c8c125bb74a3108cf67
                  start
                  216
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%225a3f7aed-1747-4c52-9e10-5aa090dd088e%22
                  spl effective date
                  2025-01-08
                  spl set id
                  58a3c995-5ad6-465d-8437-5970c9088213
                  spl version
                  2
                  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