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LABELS · a43dcc9a-83c6-45eb-ab06-20ccc51306bd

YONSA

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
2026-06-08
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 YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )
Full extracted label fields
application numbers
  1. NDA210308
boxed warning exact
    brand names
    1. YONSA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b8967e10-f768-47ce-ac9e-2324c8390132
    generic names
    1. ABIRATERONE ACETATE
    id
    a43dcc9a-83c6-45eb-ab06-20ccc51306bd
    indications and usage exact
    1. 1 INDICATIONS AND USAGE YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Sun Pharmaceutical Industries, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 47335-401-81
      product ndcs
      1. 47335-401
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2046579
        2. 2046585
        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%22a43dcc9a-83c6-45eb-ab06-20ccc51306bd%22
        spl effective date
        2026-06-08
        spl effective time
        20260608
        spl set id
        b8967e10-f768-47ce-ac9e-2324c8390132
        spl version
        14
        substance names
        1. ABIRATERONE ACETATE
        uniis
        1. EM5OCB9YJ6
        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
          NDA210308
          payload
          all indexed label documents
          1. Appl No
            210308
            Application Docs Date
            2018-05-23 00:00:00
            Application Docs ID
            54311
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            210308
            Application Docs Date
            2020-09-18 00:00:00
            Application Docs ID
            64614
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            210308
            Application Docs Date
            2022-02-01 00:00:00
            Application Docs ID
            70040
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          4. Appl No
            210308
            Application Docs Date
            2022-03-25 00:00:00
            Application Docs ID
            70607
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          5. Appl No
            210308
            Application Docs Date
            2026-05-18 00:00:00
            Application Docs ID
            85937
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            210308
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2026-05-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            210308
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2022-03-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            210308
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2022-01-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            210308
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2020-09-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            210308
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2018-05-22 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA210308
          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
          2026-05-13
          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
            210308
            Application Docs Date
            2026-05-18 00:00:00
            Application Docs ID
            85937
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          official application record
          Appl No
          210308
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          SUN PHARM
          openfda application present
          true
          products
          1. Active Ingredient
            ABIRATERONE ACETATE
            Appl No
            210308
            Drug Name
            YONSA
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            125MG
            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. NDA210308
        brand names
        1. YONSA
        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
        338
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )
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        duplicate text group
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        generic names
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        is indicated
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        qualifier mentions
        1. context exact
          NDICATIONS AND USAGE YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          106
          end exclusive
          true
          exact text
          methylprednisolone for the treatment of pat
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        2. context exact
          with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
          kind
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          end
          160
          end exclusive
          true
          exact text
          metastatic castration-resistant prostate ca
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        3. context exact
          with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
          kind
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          162
          end exclusive
          true
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          metastatic castration-resistant prostate canc
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        4. context exact
          1 INDICATIONS AND USAGE YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
          kind
          regimen
          polarity
          not_inferred
          span
          end
          164
          end exclusive
          true
          exact text
          in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer
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          offset unit
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          source field
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            1 INDICATIONS AND USAGE YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
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            spl effective date
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            spl set id
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            spl version
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            structured fields status
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            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
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            brand names
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            clinical review status
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            exact text
            1 INDICATIONS AND USAGE YONSA is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )
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            is a CYP17 inhibitor indicated
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            qualifier mentions
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              YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (
              kind
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              methylprednisolone for the treatment of pat
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              kind
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              polarity
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              320
              end exclusive
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              exact text
              metastatic castration-resistant prostate ca
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              metastatic castration-resistant prostate canc
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            4. context exact
              YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
              kind
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                YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
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                ation-resistant prostate cancer. YONSA is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )
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                      ( 1 )
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                      source url
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                      spl effective date
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                      spl set id
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                      structured fields status
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                      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