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LABELS · 18405060-7e60-4a8d-ad8f-cf6e338ec217

BOSULIF

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
2026-05-28
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 )
Full extracted label fields
application numbers
  1. NDA203341
boxed warning exact
    brand names
    1. BOSULIF
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5929f91-6496-4c0e-97e8-0bd524e15763
    generic names
    1. BOSUTINIB
    id
    18405060-7e60-4a8d-ad8f-cf6e338ec217
    indications and usage exact
    1. 1 INDICATIONS AND USAGE BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. U.S. Pharmaceuticals
      matched search terms
      1. leukemia
      package ndcs
      1. 63539-117-01
      2. 63539-193-30
      product ndcs
      1. 63539-193
      2. 63539-117
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1307624
        2. 1307630
        3. 1987732
        4. 1987734
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.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
        0
        total
        830
        sha256
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        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=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2218405060-7e60-4a8d-ad8f-cf6e338ec217%22
        spl effective date
        2026-05-28
        spl effective time
        20260528
        spl set id
        d5929f91-6496-4c0e-97e8-0bd524e15763
        spl version
        6
        substance names
        1. BOSUTINIB MONOHYDRATE
        uniis
        1. 844ZJE6I55
        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
          NDA203341
          payload
          all indexed label documents
          1. Appl No
            203341
            Application Docs Date
            2012-09-04 00:00:00
            Application Docs ID
            19458
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            203341
            Application Docs Date
            2015-10-06 00:00:00
            Application Docs ID
            19459
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          3. Appl No
            203341
            Application Docs Date
            2016-04-05 00:00:00
            Application Docs ID
            19460
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          4. Appl No
            203341
            Application Docs Date
            2013-09-30 00:00:00
            Application Docs ID
            40288
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          5. Appl No
            203341
            Application Docs Date
            2015-01-05 00:00:00
            Application Docs ID
            40289
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          6. Appl No
            203341
            Application Docs Date
            2016-11-17 00:00:00
            Application Docs ID
            45909
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          7. Appl No
            203341
            Application Docs Date
            2017-04-18 00:00:00
            Application Docs ID
            48049
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          8. Appl No
            203341
            Application Docs Date
            2017-04-18 00:00:00
            Application Docs ID
            48050
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          9. Appl No
            203341
            Application Docs Date
            2017-12-19 00:00:00
            Application Docs ID
            50777
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          10. Appl No
            203341
            Application Docs Date
            2018-10-19 00:00:00
            Application Docs ID
            56045
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          11. Appl No
            203341
            Application Docs Date
            2019-08-15 00:00:00
            Application Docs ID
            59724
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          12. Appl No
            203341
            Application Docs Date
            2019-10-10 00:00:00
            Application Docs ID
            60530
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2012-09-04 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2013-09-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            203341
            Review Priority
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2014-11-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2015-09-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2015-10-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2016-04-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2016-11-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2017-04-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2017-04-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            203341
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2017-12-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2018-05-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            203341
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2018-10-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA203341
          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
          2026-03-02
          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
            203341
            Application Docs Date
            2026-03-06 00:00:00
            Application Docs ID
            85286
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            27
            Submission Type
            SUPPL
          official application record
          Appl No
          203341
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          PF PRISM CV
          openfda application present
          true
          products
          1. Active Ingredient
            BOSUTINIB MONOHYDRATE
            Appl No
            203341
            Drug Name
            BOSULIF
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 100MG BASE
            marketing status
            1. Prescription
          2. Active Ingredient
            BOSUTINIB MONOHYDRATE
            Appl No
            203341
            Drug Name
            BOSULIF
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 500MG BASE
            marketing status
            1. Prescription
          3. Active Ingredient
            BOSUTINIB MONOHYDRATE
            Appl No
            203341
            Drug Name
            BOSULIF
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 400MG 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. NDA203341
        brand names
        1. BOSULIF
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        266
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to p
        label id
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        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
        2d81d5225d3a5876c721c28eb5c5c170e3bc38409b95069bb900f1b2e7f61a8b
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        current approval status
        not_reconciled
        duplicate text group
        dup-09066c85d1cdb4f35cc0
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. BOSUTINIB
        id
        ind-span-97422d53ed696635897d
        label id
        18405060-7e60-4a8d-ad8f-cf6e338ec217
        positive predicate support span
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        end exclusive
        true
        exact text
        is indicated
        label id
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        offset unit
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        source text sha256
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        qualifier mentions
          regulatory links
            schema version
            0.1.0
            source batch sha256
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            source defined aliases
              source span
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              66
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE BOSULIF is indicated for the treatment of:
              label id
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%2218405060-7e60-4a8d-ad8f-cf6e338ec217%22
              spl effective date
              2026-05-28
              spl set id
              d5929f91-6496-4c0e-97e8-0bd524e15763
              spl version
              6
              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
              non_oncology_or_unclear_candidate
              Passage 2 · positive indication candidate
              application numbers
              1. NDA203341
              brand names
              1. BOSULIF
              classification reasons
              1. inherited_predicate_from_same_label_section_requires_review
              2. tumor_or_malignant_hematology_words_in_positive_statement
              clinical review status
              pending
              content role
              positive_indication_candidate
              context span
              end
              526
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for
              label id
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              offset unit
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              source text sha256
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              current approval status
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              duplicate text group
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              generic names
              1. BOSUTINIB
              id
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              label id
              18405060-7e60-4a8d-ad8f-cf6e338ec217
              positive predicate support span
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              qualifier mentions
              1. context exact
                • Adult and pediatric patients 1 year of age and older with chronic
                kind
                age
                polarity
                not_inferred
                span
                end
                74
                end exclusive
                true
                exact text
                Adult
                label id
                18405060-7e60-4a8d-ad8f-cf6e338ec217
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              2. context exact
                • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphi
                kind
                age
                polarity
                not_inferred
                span
                end
                97
                end exclusive
                true
                exact text
                pediatric patients
                label id
                18405060-7e60-4a8d-ad8f-cf6e338ec217
                offset unit
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              regulatory links
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                source defined aliases
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                  true
                  exact text
                  • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] .
                  label id
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                  offset unit
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                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%2218405060-7e60-4a8d-ad8f-cf6e338ec217%22
                  spl effective date
                  2026-05-28
                  spl set id
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                  spl version
                  6
                  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 3 · positive indication candidate
                  application numbers
                  1. NDA203341
                  brand names
                  1. BOSULIF
                  classification reasons
                  1. inherited_predicate_from_same_label_section_requires_review
                  2. tumor_or_malignant_hematology_words_in_positive_statement
                  clinical review status
                  pending
                  content role
                  positive_indication_candidate
                  context span
                  end
                  681
                  end exclusive
                  true
                  exact text
                  chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resis
                  label id
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                  offset unit
                  unicode_code_points
                  source array index
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                  source field
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                  source text sha256
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                  127
                  current approval status
                  not_reconciled
                  duplicate text group
                  dup-c0a6acbd911ef4b87dd3
                  extraction review status
                  automated_candidate_pending_source_review
                  generic names
                  1. BOSUTINIB
                  id
                  ind-span-a7b7ab02c70a44428bdb
                  label id
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                  positive predicate support span
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                                                Preserved source evidence · Not medical advice