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LABELS · b8e1aeb8-2f0a-41b0-84d7-2c33a407926b

PURIXAN

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
2026-07-20
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.( 1.1 ) 1.1 Acute Lymphoblastic Leukemia PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Full extracted label fields
application numbers
  1. NDA205919
boxed warning exact
    brand names
    1. PURIXAN
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fd27952-7787-47d9-b6cf-7af2dc38217b
    generic names
    1. PURIXAN
    id
    b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.( 1.1 ) 1.1 Acute Lymphoblastic Leukemia PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Nova Laboratories, Ltd
      matched search terms
      1. leukemia
      package ndcs
      1. 62484-0020-1
      2. 62484-0020-2
      product ndcs
      1. 62484-0020
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1536484
        2. 1536490
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00600.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
        600
        total
        830
        sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        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=600&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22b8e1aeb8-2f0a-41b0-84d7-2c33a407926b%22
        spl effective date
        2026-07-20
        spl effective time
        20260720
        spl set id
        9fd27952-7787-47d9-b6cf-7af2dc38217b
        spl version
        30
        substance names
        1. MERCAPTOPURINE
        uniis
        1. E7WED276I5
        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          NDA205919
          payload
          all indexed label documents
          1. Appl No
            205919
            Application Docs Date
            2014-04-28 00:00:00
            Application Docs ID
            40520
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            205919
            Application Docs Date
            2017-05-09 00:00:00
            Application Docs ID
            48319
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          3. Appl No
            205919
            Application Docs Date
            2018-02-23 00:00:00
            Application Docs ID
            52692
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          4. Appl No
            205919
            Application Docs Date
            2020-04-17 00:00:00
            Application Docs ID
            62589
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          5. Appl No
            205919
            Application Docs Date
            2024-07-15 00:00:00
            Application Docs ID
            79071
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          6. Appl No
            205919
            Application Docs Date
            2024-10-25 00:00:00
            Application Docs ID
            79976
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          7. Appl No
            205919
            Application Docs Date
            2026-07-21 00:00:00
            Application Docs ID
            86619
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2014-04-28 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2014-12-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2017-05-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2018-02-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2020-04-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2024-10-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2024-07-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2026-07-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA205919
          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
          2026-07-16
          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
            205919
            Application Docs Date
            2026-07-21 00:00:00
            Application Docs ID
            86619
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          official application record
          Appl No
          205919
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          NOVA LABS LTD
          openfda application present
          true
          products
          1. Active Ingredient
            MERCAPTOPURINE
            Appl No
            205919
            Drug Name
            PURIXAN
            Form
            SUSPENSION;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            20MG/ML
            marketing status
            1. Prescription

        Source passages and status connections

        Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

        Passage 1 · positive indication candidate
        application numbers
        1. NDA205919
        brand names
        1. PURIXAN
        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
        396
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.( 1.1 ) 1.1 Acute Lymphoblastic Leukemia PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
        label id
        b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        9782f65eb1d53ff29b5f3b9dc1147d04bd361fd1f9a53b61a13ba5598a1f8421
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-5b59e34f17f82f5f5d08
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. PURIXAN
        id
        ind-span-2f747df70d1dd13247a6
        label id
        b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
        positive predicate support span
        end
        77
        end exclusive
        true
        exact text
        is a nucleoside metabolic inhibitor indicated
        label id
        b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        9782f65eb1d53ff29b5f3b9dc1147d04bd361fd1f9a53b61a13ba5598a1f8421
        start
        32
        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          91
          end exclusive
          true
          exact text
          metabolic inhibitor indicated for the treat
          label id
          b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          9782f65eb1d53ff29b5f3b9dc1147d04bd361fd1f9a53b61a13ba5598a1f8421
          start
          48
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
          source defined aliases
            source span
            end
            213
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.( 1.1 )
            label id
            b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9782f65eb1d53ff29b5f3b9dc1147d04bd361fd1f9a53b61a13ba5598a1f8421
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22b8e1aeb8-2f0a-41b0-84d7-2c33a407926b%22
            spl effective date
            2026-07-20
            spl set id
            9fd27952-7787-47d9-b6cf-7af2dc38217b
            spl version
            30
            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. NDA205919
            brand names
            1. PURIXAN
            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
            396
            end exclusive
            true
            exact text
            AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.( 1.1 ) 1.1 Acute Lymphoblastic Leukemia PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
            label id
            b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
            offset unit
            unicode_code_points
            source array index
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            source field
            indications_and_usage_exact
            source text sha256
            9782f65eb1d53ff29b5f3b9dc1147d04bd361fd1f9a53b61a13ba5598a1f8421
            start
            14
            current approval status
            not_reconciled
            duplicate text group
            dup-022bf8861f1028604214
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. PURIXAN
            id
            ind-span-7bd55f3f85888293742b
            label id
            b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
            positive predicate support span
            end
            267
            end exclusive
            true
            exact text
            is indicated
            label id
            b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
            offset unit
            unicode_code_points
            source array index
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            source field
            indications_and_usage_exact
            source text sha256
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            start
            255
            qualifier mentions
              regulatory links
                schema version
                0.1.0
                source batch sha256
                a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                source defined aliases
                  source span
                  end
                  396
                  end exclusive
                  true
                  exact text
                  1.1 Acute Lymphoblastic Leukemia PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
                  label id
                  b8e1aeb8-2f0a-41b0-84d7-2c33a407926b
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  9782f65eb1d53ff29b5f3b9dc1147d04bd361fd1f9a53b61a13ba5598a1f8421
                  start
                  214
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%22b8e1aeb8-2f0a-41b0-84d7-2c33a407926b%22
                  spl effective date
                  2026-07-20
                  spl set id
                  9fd27952-7787-47d9-b6cf-7af2dc38217b
                  spl version
                  30
                  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