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LABELS · 1b026a12-462b-40f3-81d8-099c1b111718

ONUREG

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
2026-06-12
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 ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy ( 1 ).
Full extracted label fields
application numbers
  1. NDA214120
boxed warning exact
    brand names
    1. ONUREG
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0e95e33f-8aba-4f19-b332-2416580d358b
    generic names
    1. AZACITIDINE
    id
    1b026a12-462b-40f3-81d8-099c1b111718
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy ( 1 ).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Celgene Corporation
      matched search terms
      1. leukemia
      package ndcs
      1. 59572-730-14
      2. 59572-730-07
      3. 59572-740-14
      4. 59572-740-07
      product ndcs
      1. 59572-730
      2. 59572-740
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.2 ) 04/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2396764
      2. 2396770
      3. 2396772
      4. 2396774
      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%221b026a12-462b-40f3-81d8-099c1b111718%22
      spl effective date
      2026-06-12
      spl effective time
      20260612
      spl set id
      0e95e33f-8aba-4f19-b332-2416580d358b
      spl version
      14
      substance names
      1. AZACITIDINE
      uniis
      1. M801H13NRU
      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
        NDA214120
        payload
        all indexed label documents
        1. Appl No
          214120
          Application Docs Date
          2020-09-01 00:00:00
          Application Docs ID
          64467
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          214120
          Application Docs Date
          2022-01-11 00:00:00
          Application Docs ID
          69839
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          214120
          Application Docs Date
          2026-04-14 00:00:00
          Application Docs ID
          85677
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          214120
          Review Priority
          PRIORITY
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2020-09-01 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          214120
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2021-05-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          214120
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2026-04-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA214120
        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
        2026-04-09
        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
          214120
          Application Docs Date
          2026-04-14 00:00:00
          Application Docs ID
          85677
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        official application record
        Appl No
        214120
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BRISTOL
        openfda application present
        true
        products
        1. Active Ingredient
          AZACITIDINE
          Appl No
          214120
          Drug Name
          ONUREG
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          200MG
          marketing status
          1. Prescription
        2. Active Ingredient
          AZACITIDINE
          Appl No
          214120
          Drug Name
          ONUREG
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          300MG
          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. NDA214120
      brand names
      1. ONUREG
      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
      521
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomp
      label id
      1b026a12-462b-40f3-81d8-099c1b111718
      offset unit
      unicode_code_points
      source array index
      0
      source field
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      source text sha256
      eb05a41b88b72cee27b6a650ceb2299a85503b161f5ef869e86cecdcd4415f01
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-384b9666a87421b8418f
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. AZACITIDINE
      id
      ind-span-ce0ca5a86c4340ecf215
      label id
      1b026a12-462b-40f3-81d8-099c1b111718
      positive predicate support span
      end
      43
      end exclusive
      true
      exact text
      is indicated
      label id
      1b026a12-462b-40f3-81d8-099c1b111718
      offset unit
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      source field
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      source text sha256
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      start
      31
      qualifier mentions
      1. context exact
        NS AND USAGE ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete rem
        kind
        age
        polarity
        not_inferred
        span
        end
        85
        end exclusive
        true
        exact text
        adult patients
        label id
        1b026a12-462b-40f3-81d8-099c1b111718
        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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        start
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      regulatory links
        schema version
        0.1.0
        source batch sha256
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        source defined aliases
          source span
          end
          321
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
          label id
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          offset unit
          unicode_code_points
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          source field
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          source text sha256
          eb05a41b88b72cee27b6a650ceb2299a85503b161f5ef869e86cecdcd4415f01
          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%221b026a12-462b-40f3-81d8-099c1b111718%22
          spl effective date
          2026-06-12
          spl set id
          0e95e33f-8aba-4f19-b332-2416580d358b
          spl version
          14
          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. NDA214120
          brand names
          1. ONUREG
          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
          658
          end exclusive
          true
          exact text
          eved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy ( 1 ).
          label id
          1b026a12-462b-40f3-81d8-099c1b111718
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
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          start
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          current approval status
          not_reconciled
          duplicate text group
          dup-2cdbca992d9a871ac5a6
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. AZACITIDINE
          id
          ind-span-527ecedb25f1250b3d14
          label id
          1b026a12-462b-40f3-81d8-099c1b111718
          positive predicate support span
          end
          374
          end exclusive
          true
          exact text
          is a nucleoside metabolic inhibitor indicated
          label id
          1b026a12-462b-40f3-81d8-099c1b111718
          offset unit
          unicode_code_points
          source array index
          0
          source field
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          source text sha256
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          start
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          qualifier mentions
          1. context exact
            de metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete rem
            kind
            age
            polarity
            not_inferred
            span
            end
            416
            end exclusive
            true
            exact text
            adult patients
            label id
            1b026a12-462b-40f3-81d8-099c1b111718
            offset unit
            unicode_code_points
            source array index
            0
            source field
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            source text sha256
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            start
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          2. context exact
            ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            388
            end exclusive
            true
            exact text
            metabolic inhibitor indicated for continued
            label id
            1b026a12-462b-40f3-81d8-099c1b111718
            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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            start
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          regulatory links
            schema version
            0.1.0
            source batch sha256
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            source defined aliases
              source span
              end
              658
              end exclusive
              true
              exact text
              ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy ( 1 ).
              label id
              1b026a12-462b-40f3-81d8-099c1b111718
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              eb05a41b88b72cee27b6a650ceb2299a85503b161f5ef869e86cecdcd4415f01
              start
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%221b026a12-462b-40f3-81d8-099c1b111718%22
              spl effective date
              2026-06-12
              spl set id
              0e95e33f-8aba-4f19-b332-2416580d358b
              spl version
              14
              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