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LABELS · 5467687f-51ac-1f50-e063-6394a90ab3f7

ABIRATERONE ACETATE

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
2026-06-16
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate 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. ABIRATERONE ACETATE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=445e70a1-25bd-8fc1-e063-6394a90a1a43
    generic names
    1. ABIRATERONE ACETATE
    id
    5467687f-51ac-1f50-e063-6394a90ab3f7
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate 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
        manufacturer names
        1. Golden State Medical Supply, Inc.
        matched search terms
        1. cancer
        package ndcs
        1. 51407-503-12
        product ndcs
        1. 51407-503
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2046579
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00300.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
        300
        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2026-06-16
        spl effective time
        20260616
        spl set id
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        spl version
        3
        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
        4. not_identified_as_original_packager
        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. ABIRATERONE ACETATE
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
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        context span
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        366
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate 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. ABIRATERONE ACETATE
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        is indicated
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        qualifier mentions
        1. context exact
          USAGE Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
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          end exclusive
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          methylprednisolone for the treatment of pat
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          with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
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          exact text
          metastatic castration-resistant prostate ca
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        3. context exact
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          metastatic castration-resistant prostate canc
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        4. context exact
          1 INDICATIONS AND USAGE Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
          kind
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          not_inferred
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          true
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          in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer
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            1 INDICATIONS AND USAGE Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.
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            Source null
            regimen
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            tumor histology
            Source null
            use intent
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            Passage 2 · positive indication candidate
            application numbers
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            brand names
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            1 INDICATIONS AND USAGE Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate 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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              Acetate is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (
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              methylprednisolone for the treatment of pat
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                      Preserved source evidence · Not medical advice