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LABELS · 9395c6cd-8f49-423e-839b-0c3aeb89b371

CASODEX

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

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE CASODEX 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. CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • CASODEX 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) • CASODEX 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. CASODEX
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dfee4fe7-8478-4a3e-925d-00be3cd0ab67
    generic names
    1. BICALUTAMIDE
    id
    9395c6cd-8f49-423e-839b-0c3aeb89b371
    indications and usage exact
    1. 1. INDICATIONS AND USAGE CASODEX 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. CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • CASODEX 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) • CASODEX 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. 62559-680-30
      product ndcs
      1. 62559-680
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 108828
        2. 199123
        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%229395c6cd-8f49-423e-839b-0c3aeb89b371%22
        spl effective date
        2026-02-27
        spl effective time
        20260227
        spl set id
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        spl version
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        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
        3. individual_indications_not_split_or_reconciled
        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. CASODEX
        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 CASODEX 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
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        dup-d71b3eba691da4e5a6d4
        extraction review status
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        generic names
        1. BICALUTAMIDE
        id
        ind-span-b690c9d5ca4888d894bf
        label id
        9395c6cd-8f49-423e-839b-0c3aeb89b371
        positive predicate support span
        Source null
        qualifier mentions
          regulatory links
            schema version
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            source batch sha256
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              1.
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              source text sha256
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              start
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%229395c6cd-8f49-423e-839b-0c3aeb89b371%22
              spl effective date
              2026-02-27
              spl set id
              dfee4fe7-8478-4a3e-925d-00be3cd0ab67
              spl version
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              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. NDA020498
              brand names
              1. CASODEX
              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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              416
              end exclusive
              true
              exact text
              1. INDICATIONS AND USAGE CASODEX 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. CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • CASODEX 50 mg is an androgen receptor inhibitor indicated for use in combination therapy
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              id
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              positive predicate support span
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              true
              exact text
              is indicated
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              qualifier mentions
              1. context exact
                easing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate.
                kind
                biomarker
                polarity
                not_inferred
                span
                end
                215
                end exclusive
                true
                exact text
                metastatic carcinoma of the prostate
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              2. context exact
                easing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate.
                kind
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                not_inferred
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                end exclusive
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                exact text
                metastatic carcinoma of the prostate
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              regulatory links
                schema version
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                source batch sha256
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                source defined aliases
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                  exact text
                  INDICATIONS AND USAGE CASODEX 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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                  source text sha256
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                  start
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                  source url
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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 3 · limitation of use
                  application numbers
                  1. NDA020498
                  brand names
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                  clinical review status
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                  524
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                  true
                  exact text
                  D USAGE CASODEX 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. CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • CASODEX 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 carcino
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                  offset unit
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                  current approval status
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                  label id
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                  positive predicate support span
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                    regulatory links
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                        exact text
                        CASODEX 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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                        spl effective date
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                        spl set id
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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
                        not_applicable
                        Passage 4 · positive indication candidate
                        application numbers
                        1. NDA020498
                        brand names
                        1. CASODEX
                        classification reasons
                        1. explicit_positive_indication_predicate
                        2. tumor_or_malignant_hematology_words_in_positive_statement
                        clinical review status
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                        context span
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                        630
                        end exclusive
                        true
                        exact text
                        hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • CASODEX 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) • CASODEX 150 mg daily is not approved for use alone or with other treatments. (1)
                        label id
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                        offset unit
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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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                        generic names
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                        label id
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                        positive predicate support span
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                        384
                        end exclusive
                        true
                        exact text
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                                              Preserved source evidence · Not medical advice