Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 8e86a087-ef8d-424c-8cfe-208bf8d4e122

Fruzaqla

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
2026-07-31
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. ( 1 )
Full extracted label fields
application numbers
  1. NDA217564
boxed warning exact
    brand names
    1. Fruzaqla
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=186d786e-dc8a-45f2-b5e1-01ac0201879f
    generic names
    1. FRUQUINTINIB
    id
    8e86a087-ef8d-424c-8cfe-208bf8d4e122
    indications and usage exact
    1. 1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Takeda Pharmaceuticals America, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 63020-210-21
      2. 63020-225-21
      product ndcs
      1. 63020-210
      2. 63020-225
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.2 ) 2/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2670184
      2. 2670190
      3. 2670196
      4. 2670198
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00500.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
      500
      total
      830
      sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      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=500&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%228e86a087-ef8d-424c-8cfe-208bf8d4e122%22
      spl effective date
      2026-07-31
      spl effective time
      20260731
      spl set id
      186d786e-dc8a-45f2-b5e1-01ac0201879f
      spl version
      8
      substance names
      1. FRUQUINTINIB
      uniis
      1. 49DXG3M5ZW
      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
        NDA217564
        payload
        all indexed label documents
        1. Appl No
          217564
          Application Docs Date
          2023-11-08 00:00:00
          Application Docs ID
          76542
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          217564
          Application Docs Date
          2025-03-03 00:00:00
          Application Docs ID
          81390
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          217564
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-11-08 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          217564
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2025-02-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA217564
        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
        2025-02-28
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          217564
          Application Docs Date
          2025-03-03 00:00:00
          Application Docs ID
          81390
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        official application record
        Appl No
        217564
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        TAKEDA PHARMS USA
        openfda application present
        true
        products
        1. Active Ingredient
          FRUQUINTINIB
          Appl No
          217564
          Drug Name
          FRUZAQLA
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          1MG
          marketing status
          1. Prescription
        2. Active Ingredient
          FRUQUINTINIB
          Appl No
          217564
          Drug Name
          FRUZAQLA
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          5MG
          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 · unclassified context
      application numbers
      1. NDA217564
      brand names
      1. Fruzaqla
      classification reasons
      1. no_unambiguous_positive_indication_predicate
      clinical review status
      pending
      content role
      unclassified_context
      context span
      end
      202
      end exclusive
      true
      exact text
      1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and iri
      label id
      8e86a087-ef8d-424c-8cfe-208bf8d4e122
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-62706471ee34d11a45c4
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. FRUQUINTINIB
      id
      ind-span-ccca8d4b079f16a02411
      label id
      8e86a087-ef8d-424c-8cfe-208bf8d4e122
      positive predicate support span
      Source null
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
          source defined aliases
            source span
            end
            2
            end exclusive
            true
            exact text
            1.
            label id
            8e86a087-ef8d-424c-8cfe-208bf8d4e122
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%228e86a087-ef8d-424c-8cfe-208bf8d4e122%22
            spl effective date
            2026-07-31
            spl set id
            186d786e-dc8a-45f2-b5e1-01ac0201879f
            spl version
            8
            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 2 · positive indication candidate
            application numbers
            1. NDA217564
            brand names
            1. Fruzaqla
            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
            522
            end exclusive
            true
            exact text
            1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinot
            label id
            8e86a087-ef8d-424c-8cfe-208bf8d4e122
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-19157316010b5536fa34
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. FRUQUINTINIB
            id
            ind-span-e80c4ec4196a0d474bbf
            label id
            8e86a087-ef8d-424c-8cfe-208bf8d4e122
            positive predicate support span
            end
            46
            end exclusive
            true
            exact text
            is indicated
            label id
            8e86a087-ef8d-424c-8cfe-208bf8d4e122
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
            start
            34
            qualifier mentions
            1. context exact
              ATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been prev
              kind
              age
              polarity
              not_inferred
              span
              end
              82
              end exclusive
              true
              exact text
              adult patients
              label id
              8e86a087-ef8d-424c-8cfe-208bf8d4e122
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
              start
              68
            2. context exact
              ZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplati
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              131
              end exclusive
              true
              exact text
              metastatic colorectal cancer (mCRC) who hav
              label id
              8e86a087-ef8d-424c-8cfe-208bf8d4e122
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
              start
              88
            3. context exact
              y, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              321
              end exclusive
              true
              exact text
              EGFR therapy
              label id
              8e86a087-ef8d-424c-8cfe-208bf8d4e122
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
              start
              309
            4. context exact
              ZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              133
              end exclusive
              true
              exact text
              metastatic colorectal cancer (mCRC) who have
              label id
              8e86a087-ef8d-424c-8cfe-208bf8d4e122
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
              start
              88
            5. context exact
              ents with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
              kind
              prior_therapy_or_line
              polarity
              not_inferred
              span
              end
              316
              end exclusive
              true
              exact text
              previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR th
              label id
              8e86a087-ef8d-424c-8cfe-208bf8d4e122
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
              start
              138
            regulatory links
              schema version
              0.1.0
              source batch sha256
              424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
              source defined aliases
                source span
                end
                322
                end exclusive
                true
                exact text
                INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
                label id
                8e86a087-ef8d-424c-8cfe-208bf8d4e122
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                start
                3
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%228e86a087-ef8d-424c-8cfe-208bf8d4e122%22
                spl effective date
                2026-07-31
                spl set id
                186d786e-dc8a-45f2-b5e1-01ac0201879f
                spl version
                8
                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. NDA217564
                brand names
                1. Fruzaqla
                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
                645
                end exclusive
                true
                exact text
                who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. ( 1 )
                label id
                8e86a087-ef8d-424c-8cfe-208bf8d4e122
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                start
                123
                current approval status
                not_reconciled
                duplicate text group
                dup-abcf1ff6199e30e2870f
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. FRUQUINTINIB
                id
                ind-span-869fd98865ea14f30252
                label id
                8e86a087-ef8d-424c-8cfe-208bf8d4e122
                positive predicate support span
                end
                363
                end exclusive
                true
                exact text
                is a kinase inhibitor indicated
                label id
                8e86a087-ef8d-424c-8cfe-208bf8d4e122
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                start
                332
                qualifier mentions
                1. context exact
                  UZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been prev
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  399
                  end exclusive
                  true
                  exact text
                  adult patients
                  label id
                  8e86a087-ef8d-424c-8cfe-208bf8d4e122
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                  start
                  385
                2. context exact
                  nhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplati
                  kind
                  biomarker
                  polarity
                  not_inferred
                  span
                  end
                  448
                  end exclusive
                  true
                  exact text
                  metastatic colorectal cancer (mCRC) who hav
                  label id
                  8e86a087-ef8d-424c-8cfe-208bf8d4e122
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                  start
                  405
                3. context exact
                  y, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
                  kind
                  biomarker
                  polarity
                  not_inferred
                  span
                  end
                  638
                  end exclusive
                  true
                  exact text
                  EGFR therapy
                  label id
                  8e86a087-ef8d-424c-8cfe-208bf8d4e122
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                  start
                  626
                4. context exact
                  nhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑
                  kind
                  stage_or_setting
                  polarity
                  not_inferred
                  span
                  end
                  450
                  end exclusive
                  true
                  exact text
                  metastatic colorectal cancer (mCRC) who have
                  label id
                  8e86a087-ef8d-424c-8cfe-208bf8d4e122
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                  start
                  405
                5. context exact
                  ents with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
                  kind
                  prior_therapy_or_line
                  polarity
                  not_inferred
                  span
                  end
                  633
                  end exclusive
                  true
                  exact text
                  previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR th
                  label id
                  8e86a087-ef8d-424c-8cfe-208bf8d4e122
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                  start
                  455
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                  source defined aliases
                    source span
                    end
                    639
                    end exclusive
                    true
                    exact text
                    FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
                    label id
                    8e86a087-ef8d-424c-8cfe-208bf8d4e122
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                    start
                    323
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%228e86a087-ef8d-424c-8cfe-208bf8d4e122%22
                    spl effective date
                    2026-07-31
                    spl set id
                    186d786e-dc8a-45f2-b5e1-01ac0201879f
                    spl version
                    8
                    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 4 · unclassified context
                    application numbers
                    1. NDA217564
                    brand names
                    1. Fruzaqla
                    classification reasons
                    1. no_unambiguous_positive_indication_predicate
                    clinical review status
                    pending
                    content role
                    unclassified_context
                    context span
                    end
                    645
                    end exclusive
                    true
                    exact text
                    who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. ( 1 )
                    label id
                    8e86a087-ef8d-424c-8cfe-208bf8d4e122
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                    start
                    440
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-62706471ee34d11a45c4
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. FRUQUINTINIB
                    id
                    ind-span-2e8aa099fa35de115b36
                    label id
                    8e86a087-ef8d-424c-8cfe-208bf8d4e122
                    positive predicate support span
                    Source null
                    qualifier mentions
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                        source defined aliases
                          source span
                          end
                          645
                          end exclusive
                          true
                          exact text
                          ( 1 )
                          label id
                          8e86a087-ef8d-424c-8cfe-208bf8d4e122
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          4d74c0a89d6fdcc3c5e40879ab8f4731ba96d003259282cae574ac30143769e8
                          start
                          640
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%228e86a087-ef8d-424c-8cfe-208bf8d4e122%22
                          spl effective date
                          2026-07-31
                          spl set id
                          186d786e-dc8a-45f2-b5e1-01ac0201879f
                          spl version
                          8
                          structured fields status
                          not_extracted_no_values_inferred_from_mentions
                          structured indication
                          age
                          Source null
                          approval pathway
                          Source null
                          biomarker and test
                          Source null
                          disease stage
                          Source null
                          limitations
                          Source null
                          line
                          Source null
                          prior therapy
                          Source null
                          regimen
                          Source null
                          tumor histology
                          Source null
                          use intent
                          unclear

                          Preserved source evidence · Not medical advice