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LABELS · 860a6889-e984-452f-9f99-f4c68ba6eaca

SPRYCEL

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
2026-08-21
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 SPRYCEL (dasatinib) is indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with • Ph+ CML in chronic phase. • newly diagnosed Ph+ ALL in combination with chemotherapy. SPRYCEL is a kinase inhibitor indicated for the treatment of • newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) • adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) • adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) • pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) • pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)
Full extracted label fields
application numbers
  1. NDA021986
boxed warning exact
    brand names
    1. SPRYCEL
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4764f37b-c9e6-4ede-bcc2-8a03b7c521df
    generic names
    1. DASATINIB
    id
    860a6889-e984-452f-9f99-f4c68ba6eaca
    indications and usage exact
    1. 1 INDICATIONS AND USAGE SPRYCEL (dasatinib) is indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with • Ph+ CML in chronic phase. • newly diagnosed Ph+ ALL in combination with chemotherapy. SPRYCEL is a kinase inhibitor indicated for the treatment of • newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) • adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) • adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) • pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) • pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. E.R. Squibb & Sons, L.L.C.
      matched search terms
      1. leukemia
      package ndcs
      1. 0003-0527-11
      2. 0003-0528-11
      3. 0003-0524-11
      4. 0003-0855-22
      5. 0003-0852-22
      6. 0003-0857-22
      product ndcs
      1. 0003-0524
      2. 0003-0527
      3. 0003-0528
      4. 0003-0855
      5. 0003-0852
      6. 0003-0857
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 643105
        2. 643107
        3. 643109
        4. 643173
        5. 643175
        6. 643177
        7. 799047
        8. 799830
        9. 1045402
        10. 1045404
        11. 1045406
        12. 1045408
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00400.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
        400
        total
        830
        sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        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=400&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22860a6889-e984-452f-9f99-f4c68ba6eaca%22
        spl effective date
        2026-08-21
        spl effective time
        20260821
        spl set id
        4764f37b-c9e6-4ede-bcc2-8a03b7c521df
        spl version
        48
        substance names
        1. DASATINIB
        uniis
        1. RBZ1571X5H
        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
          NDA021986
          payload
          all indexed label documents
          1. Appl No
            021986
            Application Docs Date
            2006-07-03 00:00:00
            Application Docs ID
            16693
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            021986
            Application Docs Date
            2009-05-25 00:00:00
            Application Docs ID
            16694
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          3. Appl No
            021986
            Application Docs Date
            2010-10-28 00:00:00
            Application Docs ID
            16695
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          4. Appl No
            021986
            Application Docs Date
            2011-10-12 00:00:00
            Application Docs ID
            16696
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          5. Appl No
            021986
            Application Docs Date
            2015-08-13 00:00:00
            Application Docs ID
            16697
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          6. Appl No
            021986
            Application Docs Date
            2007-11-13 00:00:00
            Application Docs ID
            37998
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          7. Appl No
            021986
            Application Docs Date
            2010-07-31 00:00:00
            Application Docs ID
            37999
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          8. Appl No
            021986
            Application Docs Date
            2010-10-28 00:00:00
            Application Docs ID
            38000
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          9. Appl No
            021986
            Application Docs Date
            2011-10-12 00:00:00
            Application Docs ID
            38001
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          10. Appl No
            021986
            Application Docs Date
            2013-06-17 00:00:00
            Application Docs ID
            38002
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          11. Appl No
            021986
            Application Docs Date
            2014-05-12 00:00:00
            Application Docs ID
            38003
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          12. Appl No
            021986
            Application Docs Date
            2015-08-13 00:00:00
            Application Docs ID
            38004
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            28
            Submission Status
            AP
            Submission Status Date
            2024-07-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2023-02-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2021-06-29 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            2018-11-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            021986
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2018-12-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            021986
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2017-11-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2017-08-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2016-09-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2015-08-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2015-08-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            021986
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2015-01-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            021986
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2014-04-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA021986
          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
          2024-07-31
          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
            021986
            Application Docs Date
            2024-08-02 00:00:00
            Application Docs ID
            79280
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            28
            Submission Type
            SUPPL
          official application record
          Appl No
          021986
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          BRISTOL MYERS SQUIBB
          openfda application present
          true
          products
          1. Active Ingredient
            DASATINIB
            Appl No
            021986
            Drug Name
            SPRYCEL
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            20MG
            marketing status
            1. Prescription
          2. Active Ingredient
            DASATINIB
            Appl No
            021986
            Drug Name
            SPRYCEL
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            50MG
            marketing status
            1. Prescription
          3. Active Ingredient
            DASATINIB
            Appl No
            021986
            Drug Name
            SPRYCEL
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            0
            Strength
            70MG
            marketing status
            1. Prescription
          4. Active Ingredient
            DASATINIB
            Appl No
            021986
            Drug Name
            SPRYCEL
            Form
            TABLET;ORAL
            Product No
            004
            Reference Drug
            1
            Reference Standard
            1
            Strength
            100MG
            marketing status
            1. Prescription
          5. Active Ingredient
            DASATINIB
            Appl No
            021986
            Drug Name
            SPRYCEL
            Form
            TABLET;ORAL
            Product No
            005
            Reference Drug
            1
            Reference Standard
            0
            Strength
            80MG
            marketing status
            1. Prescription
          6. Active Ingredient
            DASATINIB
            Appl No
            021986
            Drug Name
            SPRYCEL
            Form
            TABLET;ORAL
            Product No
            006
            Reference Drug
            1
            Reference Standard
            0
            Strength
            140MG
            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. NDA021986
        brand names
        1. SPRYCEL
        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
        297
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE SPRYCEL (dasatinib) is indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intoler
        label id
        860a6889-e984-452f-9f99-f4c68ba6eaca
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        37c76725078537b17387d95557de6e44566f5c4d8b983e97c4562379ddc915d8
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-c13bbd59c9313eec1653
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. DASATINIB
        id
        ind-span-ead9210d9ba639c6bdf5
        label id
        860a6889-e984-452f-9f99-f4c68ba6eaca
        positive predicate support span
        end
        56
        end exclusive
        true
        exact text
        is indicated
        label id
        860a6889-e984-452f-9f99-f4c68ba6eaca
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        37c76725078537b17387d95557de6e44566f5c4d8b983e97c4562379ddc915d8
        start
        44
        qualifier mentions
        1. context exact
          USAGE SPRYCEL (dasatinib) is indicated for the treatment of adult patients with
          kind
          age
          polarity
          not_inferred
          span
          end
          92
          end exclusive
          true
          exact text
          adult patients
          label id
          860a6889-e984-452f-9f99-f4c68ba6eaca
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          37c76725078537b17387d95557de6e44566f5c4d8b983e97c4562379ddc915d8
          start
          78
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
          source defined aliases
            source span
            end
            97
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE SPRYCEL (dasatinib) is indicated for the treatment of adult patients with
            label id
            860a6889-e984-452f-9f99-f4c68ba6eaca
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            37c76725078537b17387d95557de6e44566f5c4d8b983e97c4562379ddc915d8
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22860a6889-e984-452f-9f99-f4c68ba6eaca%22
            spl effective date
            2026-08-21
            spl set id
            4764f37b-c9e6-4ede-bcc2-8a03b7c521df
            spl version
            48
            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 · unclassified context
            application numbers
            1. NDA021986
            brand names
            1. SPRYCEL
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            403
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE SPRYCEL (dasatinib) is indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • Philadelphia chromosome-positive acute lymphoblastic leukemia
            label id
            860a6889-e984-452f-9f99-f4c68ba6eaca
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            37c76725078537b17387d95557de6e44566f5c4d8b983e97c4562379ddc915d8
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-0138e3f270786e7a6734
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. DASATINIB
            id
            ind-span-556a75a39e4822d75b78
            label id
            860a6889-e984-452f-9f99-f4c68ba6eaca
            positive predicate support span
            Source null
            qualifier mentions
              regulatory links
                schema version
                0.1.0
                source batch sha256
                a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                source defined aliases
                  source span
                  end
                  203
                  end exclusive
                  true
                  exact text
                  • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
                  label id
                  860a6889-e984-452f-9f99-f4c68ba6eaca
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  37c76725078537b17387d95557de6e44566f5c4d8b983e97c4562379ddc915d8
                  start
                  98
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%22860a6889-e984-452f-9f99-f4c68ba6eaca%22
                  spl effective date
                  2026-08-21
                  spl set id
                  4764f37b-c9e6-4ede-bcc2-8a03b7c521df
                  spl version
                  48
                  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 3 · unclassified context
                  application numbers
                  1. NDA021986
                  brand names
                  1. SPRYCEL
                  classification reasons
                  1. no_unambiguous_positive_indication_predicate
                  clinical review status
                  pending
                  content role
                  unclassified_context
                  context span
                  end
                  538
                  end exclusive
                  true
                  exact text
                  DICATIONS AND USAGE SPRYCEL (dasatinib) is indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 y
                  label id
                  860a6889-e984-452f-9f99-f4c68ba6eaca
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  37c76725078537b17387d95557de6e44566f5c4d8b983e97c4562379ddc915d8
                  start
                  4
                  current approval status
                  not_reconciled
                  duplicate text group
                  dup-cabd2ea711e4d52d0ee9
                  extraction review status
                  automated_candidate_pending_source_review
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                                                                                                    Preserved source evidence · Not medical advice