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LABELS · 288ecd1b-0244-dd13-e063-6394a90a739d

Gliadel

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
2024-12-05
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery. GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation ( 1 ) and recurrent glioblastoma as an adjunct to surgery ( 1 )
Full extracted label fields
application numbers
  1. NDA020637
boxed warning exact
    brand names
    1. Gliadel
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38962a55-a514-4c48-bea5-f99a8da4beec
    generic names
    1. CARMUSTINE
    id
    288ecd1b-0244-dd13-e063-6394a90a739d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery. GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation ( 1 ) and recurrent glioblastoma as an adjunct to surgery ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Azurity Pharmaceuticals, Inc.
      matched search terms
      1. glioma
      2. glioblastoma
      package ndcs
      1. 24338-050-08
      product ndcs
      1. 24338-050
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRACAVITARY
        rxcuis
        1. 212994
        2. 309013
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22288ecd1b-0244-dd13-e063-6394a90a739d%22
        spl effective date
        2024-12-05
        spl effective time
        20241205
        spl set id
        38962a55-a514-4c48-bea5-f99a8da4beec
        spl version
        8
        substance names
        1. CARMUSTINE
        uniis
        1. U68WG3173Y
        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
          NDA020637
          payload
          all indexed label documents
          1. Appl No
            020637
            Application Docs Date
            2003-03-05 00:00:00
            Application Docs ID
            35051
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          2. Appl No
            020637
            Application Docs Date
            2013-08-21 00:00:00
            Application Docs ID
            35052
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          3. Appl No
            020637
            Application Docs Date
            2019-01-08 00:00:00
            Application Docs ID
            57135
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020637
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            29
            Submission Status
            AP
            Submission Status Date
            2018-12-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            020637
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            28
            Submission Status
            AP
            Submission Status Date
            2015-06-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020637
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2014-11-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020637
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2013-08-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020637
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            2006-12-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020637
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2001-11-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            020637
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2003-02-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020637
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2001-05-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            020637
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2000-08-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            020637
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            1999-10-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            020637
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            1999-07-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            020637
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2000-09-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020637
          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
          2018-12-05
          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
            020637
            Application Docs Date
            2019-01-08 00:00:00
            Application Docs ID
            57135
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          official application record
          Appl No
          020637
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          AZURITY
          openfda application present
          true
          products
          1. Active Ingredient
            CARMUSTINE
            Appl No
            020637
            Drug Name
            GLIADEL
            Form
            IMPLANT;INTRACRANIAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            7.7MG
            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. NDA020637
        brand names
        1. Gliadel
        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
        413
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery. GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation ( 1 ) and recurrent glioblastoma as an adjunct to surgery
        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
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-ddea6d9046a3d6a2b2b9
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. CARMUSTINE
        id
        ind-span-9c87f46683add1859b6e
        label id
        288ecd1b-0244-dd13-e063-6394a90a739d
        positive predicate support span
        end
        50
        end exclusive
        true
        exact text
        is indicated
        label id
        288ecd1b-0244-dd13-e063-6394a90a739d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        315c582a1aa7e5502961e0edf93d2f9dfa39bb722f680ce4164c5d56bf0dc59c
        start
        38
        qualifier mentions
        1. context exact
          gh-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery.
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          209
          end exclusive
          true
          exact text
          recurrent glioblastoma as an adjunct to surg
          label id
          288ecd1b-0244-dd13-e063-6394a90a739d
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          315c582a1aa7e5502961e0edf93d2f9dfa39bb722f680ce4164c5d56bf0dc59c
          start
          165
        regulatory links
          schema version
          0.1.0
          source batch sha256
          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
          source defined aliases
            source span
            end
            213
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery.
            label id
            288ecd1b-0244-dd13-e063-6394a90a739d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            315c582a1aa7e5502961e0edf93d2f9dfa39bb722f680ce4164c5d56bf0dc59c
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22288ecd1b-0244-dd13-e063-6394a90a739d%22
            spl effective date
            2024-12-05
            spl set id
            38962a55-a514-4c48-bea5-f99a8da4beec
            spl version
            8
            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 · positive indication candidate
            application numbers
            1. NDA020637
            brand names
            1. Gliadel
            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
            418
            end exclusive
            true
            exact text
            AND USAGE GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery. GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation ( 1 ) and recurrent glioblastoma as an adjunct to surgery ( 1 )
            label id
            288ecd1b-0244-dd13-e063-6394a90a739d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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            start
            14
            current approval status
            not_reconciled
            duplicate text group
            dup-7d6abadc4eb272ec245a
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. CARMUSTINE
            id
            ind-span-6523f0f305859c72a8de
            label id
            288ecd1b-0244-dd13-e063-6394a90a739d
            positive predicate support span
            end
            259
            end exclusive
            true
            exact text
            is an alkylating drug indicated
            label id
            288ecd1b-0244-dd13-e063-6394a90a739d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            315c582a1aa7e5502961e0edf93d2f9dfa39bb722f680ce4164c5d56bf0dc59c
            start
            228
            qualifier mentions
            1. context exact
              GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surg
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              277
              end exclusive
              true
              exact text
              alkylating drug indicated for the treatment
              label id
              288ecd1b-0244-dd13-e063-6394a90a739d
              offset unit
              unicode_code_points
              source array index
              0
              source field
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              source text sha256
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              start
              234
            2. context exact
              ade glioma as an adjunct to surgery and radiation ( 1 ) and recurrent glioblastoma as an adjunct to surgery ( 1 )
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              409
              end exclusive
              true
              exact text
              recurrent glioblastoma as an adjunct to surg
              label id
              288ecd1b-0244-dd13-e063-6394a90a739d
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              315c582a1aa7e5502961e0edf93d2f9dfa39bb722f680ce4164c5d56bf0dc59c
              start
              365
            regulatory links
              schema version
              0.1.0
              source batch sha256
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              source defined aliases
                source span
                end
                418
                end exclusive
                true
                exact text
                GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation ( 1 ) and recurrent glioblastoma as an adjunct to surgery ( 1 )
                label id
                288ecd1b-0244-dd13-e063-6394a90a739d
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                315c582a1aa7e5502961e0edf93d2f9dfa39bb722f680ce4164c5d56bf0dc59c
                start
                214
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22288ecd1b-0244-dd13-e063-6394a90a739d%22
                spl effective date
                2024-12-05
                spl set id
                38962a55-a514-4c48-bea5-f99a8da4beec
                spl version
                8
                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

                Preserved source evidence · Not medical advice