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LABELS · 8934d69e-be91-4552-8fba-ccc07e4f0a20

ERLEADA

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
2026-07-02
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 ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )
Full extracted label fields
application numbers
  1. NDA210951
boxed warning exact
    brand names
    1. ERLEADA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d1cda4f7-cb33-46ea-b9ac-431f6452b1a5
    generic names
    1. APALUTAMIDE
    id
    8934d69e-be91-4552-8fba-ccc07e4f0a20
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Janssen Products, LP
      matched search terms
      1. cancer
      package ndcs
      1. 59676-600-12
      2. 59676-600-99
      3. 59676-600-56
      4. 59676-604-30
      5. 59676-604-14
      product ndcs
      1. 59676-600
      2. 59676-604
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 03/2026 Warnings and Precautions ( 5.8 ) 06/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1999581
      2. 1999587
      3. 2630215
      4. 2630217
      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%228934d69e-be91-4552-8fba-ccc07e4f0a20%22
      spl effective date
      2026-07-02
      spl effective time
      20260702
      spl set id
      d1cda4f7-cb33-46ea-b9ac-431f6452b1a5
      spl version
      29
      substance names
      1. APALUTAMIDE
      uniis
      1. 4T36H88UA7
      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
        NDA210951
        payload
        all indexed label documents
        1. Appl No
          210951
          Application Docs Date
          2018-02-14 00:00:00
          Application Docs ID
          52629
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          210951
          Application Docs Date
          2019-09-17 00:00:00
          Application Docs ID
          60027
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          210951
          Application Docs Date
          2020-07-14 00:00:00
          Application Docs ID
          63888
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          210951
          Application Docs Date
          2020-09-04 00:00:00
          Application Docs ID
          64498
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        5. Appl No
          210951
          Application Docs Date
          2020-11-23 00:00:00
          Application Docs ID
          65299
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        6. Appl No
          210951
          Application Docs Date
          2021-07-16 00:00:00
          Application Docs ID
          68105
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        7. Appl No
          210951
          Application Docs Date
          2021-09-10 00:00:00
          Application Docs ID
          68575
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        8. Appl No
          210951
          Application Docs Date
          2022-04-26 00:00:00
          Application Docs ID
          70816
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        9. Appl No
          210951
          Application Docs Date
          2022-11-10 00:00:00
          Application Docs ID
          72590
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        10. Appl No
          210951
          Application Docs Date
          2022-11-10 00:00:00
          Application Docs ID
          72591
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        11. Appl No
          210951
          Application Docs Date
          2023-03-01 00:00:00
          Application Docs ID
          73577
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        12. Appl No
          210951
          Application Docs Date
          2023-12-20 00:00:00
          Application Docs ID
          77093
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          210951
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-02-14 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          210951
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2019-09-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2020-07-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2020-09-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          210951
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2020-11-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2021-07-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2021-09-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2022-04-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2022-11-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2022-11-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2023-02-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          210951
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2023-12-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA210951
        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
        2026-06-29
        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
          210951
          Application Docs Date
          2026-07-06 00:00:00
          Application Docs ID
          86460
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          24
          Submission Type
          SUPPL
        official application record
        Appl No
        210951
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        JANSSEN BIOTECH
        openfda application present
        true
        products
        1. Active Ingredient
          APALUTAMIDE
          Appl No
          210951
          Drug Name
          ERLEADA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          60MG
          marketing status
          1. Prescription
        2. Active Ingredient
          APALUTAMIDE
          Appl No
          210951
          Drug Name
          ERLEADA
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          240MG
          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. NDA210951
      brand names
      1. ERLEADA
      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
      397
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )
      label id
      8934d69e-be91-4552-8fba-ccc07e4f0a20
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      b9da4b87ac94eff9e77828bb987fac0d7db3ae72d9b24062a1c43880ceb73b18
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-44637a3a9470eed0b904
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. APALUTAMIDE
      id
      ind-span-176b1b1ce5395630dbb9
      label id
      8934d69e-be91-4552-8fba-ccc07e4f0a20
      positive predicate support span
      end
      44
      end exclusive
      true
      exact text
      is indicated
      label id
      8934d69e-be91-4552-8fba-ccc07e4f0a20
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
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      start
      32
      qualifier mentions
      1. context exact
        AGE ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate ca
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        123
        end exclusive
        true
        exact text
        Metastatic castration-sensitive prostate ca
        label id
        8934d69e-be91-4552-8fba-ccc07e4f0a20
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b9da4b87ac94eff9e77828bb987fac0d7db3ae72d9b24062a1c43880ceb73b18
        start
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      2. context exact
        Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indi
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        183
        end exclusive
        true
        exact text
        metastatic castration-resistant prostate ca
        label id
        8934d69e-be91-4552-8fba-ccc07e4f0a20
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
        140
      3. context exact
        ptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        327
        end exclusive
        true
        exact text
        metastatic castration-sensitive prostate ca
        label id
        8934d69e-be91-4552-8fba-ccc07e4f0a20
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b9da4b87ac94eff9e77828bb987fac0d7db3ae72d9b24062a1c43880ceb73b18
        start
        284
      4. context exact
        AGE ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate canc
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        125
        end exclusive
        true
        exact text
        Metastatic castration-sensitive prostate canc
        label id
        8934d69e-be91-4552-8fba-ccc07e4f0a20
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b9da4b87ac94eff9e77828bb987fac0d7db3ae72d9b24062a1c43880ceb73b18
        start
        80
      5. context exact
        Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indica
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        185
        end exclusive
        true
        exact text
        metastatic castration-resistant prostate canc
        label id
        8934d69e-be91-4552-8fba-ccc07e4f0a20
        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
        140
      6. context exact
        ptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        329
        end exclusive
        true
        exact text
        metastatic castration-sensitive prostate canc
        label id
        8934d69e-be91-4552-8fba-ccc07e4f0a20
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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      regulatory links
        schema version
        0.1.0
        source batch sha256
        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
        source defined aliases
          source span
          end
          332
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
          label id
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          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
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%228934d69e-be91-4552-8fba-ccc07e4f0a20%22
          spl effective date
          2026-07-02
          spl set id
          d1cda4f7-cb33-46ea-b9ac-431f6452b1a5
          spl version
          29
          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 · unclassified context
          application numbers
          1. NDA210951
          brand names
          1. ERLEADA
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          397
          end exclusive
          true
          exact text
          C) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )
          label id
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          offset unit
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          source field
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          source text sha256
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          current approval status
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          duplicate text group
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          extraction review status
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          generic names
          1. APALUTAMIDE
          id
          ind-span-14ebea381f7fa35f0ccc
          label id
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          positive predicate support span
          Source null
          qualifier mentions
          1. context exact
            ( 1 ) non-metastatic castration-resistant prostate cancer.
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            386
            end exclusive
            true
            exact text
            metastatic castration-resistant prostate ca
            label id
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            offset unit
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            source field
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            source text sha256
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          2. context exact
            ( 1 ) non-metastatic castration-resistant prostate cancer.
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            388
            end exclusive
            true
            exact text
            metastatic castration-resistant prostate canc
            label id
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            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
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            source batch sha256
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            source defined aliases
              source span
              end
              391
              end exclusive
              true
              exact text
              ( 1 ) non-metastatic castration-resistant prostate cancer.
              label id
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              source url
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              spl set id
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              biomarker and test
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              disease stage
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              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              unclear
              Passage 3 · unclassified context
              application numbers
              1. NDA210951
              brand names
              1. ERLEADA
              classification reasons
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              clinical review status
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              RPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )
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              source text sha256
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              id
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              label id
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              qualifier mentions
                regulatory links
                  schema version
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                  source batch sha256
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                    ( 1 )
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                    offset unit
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                    source text sha256
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                    start
                    392
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%228934d69e-be91-4552-8fba-ccc07e4f0a20%22
                    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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                    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