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LABELS · cf149c3a-84aa-4ef8-befc-1dbeb7dcc678

Bicalutamide

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
2026-02-27
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) • Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. (1)
Full extracted label fields
application numbers
  1. NDA020498
boxed warning exact
    brand names
    1. Bicalutamide
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7a08d88b-051a-4c16-9560-12685c500c58
    generic names
    1. BICALUTAMIDE
    id
    cf149c3a-84aa-4ef8-befc-1dbeb7dcc678
    indications and usage exact
    1. 1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) • Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. (1)
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. ANI Pharmaceuticals, Inc.
      matched search terms
      1. carcinoma
      package ndcs
      1. 62559-890-30
      product ndcs
      1. 62559-890
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 199123
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00600.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
        600
        total
        830
        sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        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=600&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22cf149c3a-84aa-4ef8-befc-1dbeb7dcc678%22
        spl effective date
        2026-02-27
        spl effective time
        20260227
        spl set id
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        spl version
        3
        substance names
        1. BICALUTAMIDE
        uniis
        1. A0Z3NAU9DP
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          NDA020498
          payload
          all indexed label documents
          1. Appl No
            020498
            Application Docs Date
            2005-05-17 00:00:00
            Application Docs ID
            12639
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          2. Appl No
            020498
            Application Docs Date
            2006-03-14 00:00:00
            Application Docs ID
            12640
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            18
            Submission Type
            SUPPL
          3. Appl No
            020498
            Application Docs Date
            2009-02-12 00:00:00
            Application Docs ID
            12641
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            21
            Submission Type
            SUPPL
          4. Appl No
            020498
            Application Docs Date
            2009-02-12 00:00:00
            Application Docs ID
            34714
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          5. Appl No
            020498
            Application Docs Date
            2010-09-20 00:00:00
            Application Docs ID
            34715
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            22
            Submission Type
            SUPPL
          6. Appl No
            020498
            Application Docs Date
            2015-03-04 00:00:00
            Application Docs ID
            34716
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            25
            Submission Type
            SUPPL
          7. Appl No
            020498
            Application Docs Date
            2017-03-23 00:00:00
            Application Docs ID
            47658
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            27
            Submission Type
            SUPPL
          8. Appl No
            020498
            Application Docs Date
            2017-12-08 00:00:00
            Application Docs ID
            50647
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            28
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            28
            Submission Status
            AP
            Submission Status Date
            2017-11-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2017-03-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2015-02-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2013-09-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            2010-09-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2009-03-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2009-03-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2006-03-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2005-05-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2002-09-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2002-01-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            020498
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2001-10-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020498
          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
          2017-11-01
          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
            020498
            Application Docs Date
            2017-12-08 00:00:00
            Application Docs ID
            50647
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            28
            Submission Type
            SUPPL
          official application record
          Appl No
          020498
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ANI PHARMS
          openfda application present
          true
          products
          1. Active Ingredient
            BICALUTAMIDE
            Appl No
            020498
            Drug Name
            CASODEX
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            50MG
            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. NDA020498
        brand names
        1. Bicalutamide
        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
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        true
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        1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic
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        ind-span-e2b701ba621111655fed
        label id
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        positive predicate support span
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              start
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              source url
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              spl effective date
              2026-02-27
              spl set id
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              spl version
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              structured fields status
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              structured indication
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              Source null
              approval pathway
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              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
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              brand names
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              true
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              1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for u
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              is indicated
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              qualifier mentions
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                kind
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                not_inferred
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                end exclusive
                true
                exact text
                metastatic carcinoma of the prostate
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                metastatic carcinoma of the prostate
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              regulatory links
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                  INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate.
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                  limitations
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                  Source null
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                  Passage 3 · limitation of use
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                  utamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metas
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                        Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ].
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                        source url
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                        Source null
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                        biomarker and test
                        Source null
                        disease stage
                        Source null
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                        Source null
                        line
                        Source null
                        prior therapy
                        Source null
                        regimen
                        Source null
                        tumor histology
                        Source null
                        use intent
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                        Passage 4 · positive indication candidate
                        application numbers
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                        brand names
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                        classification reasons
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                        H) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) • Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. (1)
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                                              Preserved source evidence · Not medical advice