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LABELS · bcfd315e-9ade-4659-9f1c-dfb687ba39de

Bendeka

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
2024-01-19
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 BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) BENDEKA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Full extracted label fields
application numbers
  1. NDA208194
boxed warning exact
    brand names
    1. Bendeka
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ace9a43b-f9bd-4896-abfe-0ef4fec67ddf
    generic names
    1. BENDAMUSTINE HYDROCHLORIDE
    id
    bcfd315e-9ade-4659-9f1c-dfb687ba39de
    indications and usage exact
    1. 1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) BENDEKA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Teva Pharmaceuticals USA, Inc.
      matched search terms
      1. lymphoma
      2. leukemia
      package ndcs
      1. 63459-348-04
      product ndcs
      1. 63459-348
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1726097
        2. 1726102
        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%22bcfd315e-9ade-4659-9f1c-dfb687ba39de%22
        spl effective date
        2024-01-19
        spl effective time
        20240119
        spl set id
        ace9a43b-f9bd-4896-abfe-0ef4fec67ddf
        spl version
        22
        substance names
        1. BENDAMUSTINE HYDROCHLORIDE
        uniis
        1. 981Y8SX18M
        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
          NDA208194
          payload
          all indexed label documents
          1. Appl No
            208194
            Application Docs Date
            2015-12-08 00:00:00
            Application Docs ID
            19987
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            208194
            Application Docs Date
            2016-08-02 00:00:00
            Application Docs ID
            40623
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            208194
            Application Docs Date
            2016-06-27 00:00:00
            Application Docs ID
            40624
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          4. Appl No
            208194
            Application Docs Date
            2017-02-10 00:00:00
            Application Docs ID
            47169
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          5. Appl No
            208194
            Application Docs Date
            2018-07-31 00:00:00
            Application Docs ID
            55065
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          6. Appl No
            208194
            Application Docs Date
            2019-10-15 00:00:00
            Application Docs ID
            60572
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          7. Appl No
            208194
            Application Docs Date
            2019-12-12 00:00:00
            Application Docs ID
            61244
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          8. Appl No
            208194
            Application Docs Date
            2021-10-15 00:00:00
            Application Docs ID
            69000
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            24
            Submission Type
            SUPPL
          9. Appl No
            208194
            Application Docs Date
            2024-01-16 00:00:00
            Application Docs ID
            77228
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2015-12-07 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2016-06-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2016-06-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            208194
            Review Priority
            UNKNOWN
            Submission Class Code ID
            19
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2016-09-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            19
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2017-02-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2017-02-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2018-07-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2019-10-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2019-11-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2021-10-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            208194
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2024-01-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA208194
          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
          2024-01-11
          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
            208194
            Application Docs Date
            2024-01-16 00:00:00
            Application Docs ID
            77228
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          official application record
          Appl No
          208194
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          EAGLE PHARMS
          openfda application present
          true
          products
          1. Active Ingredient
            BENDAMUSTINE HYDROCHLORIDE
            Appl No
            208194
            Drug Name
            BENDEKA
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            100MG/4ML (25MG/ML)
            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. NDA208194
        brand names
        1. Bendeka
        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
        341
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treat
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        current approval status
        not_reconciled
        duplicate text group
        dup-8287deba44b89c5b8f29
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. BENDAMUSTINE HYDROCHLORIDE
        id
        ind-span-977f0d0f1fe0adf2da10
        label id
        bcfd315e-9ade-4659-9f1c-dfb687ba39de
        positive predicate support span
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        73
        end exclusive
        true
        exact text
        is an alkylating drug indicated
        label id
        bcfd315e-9ade-4659-9f1c-dfb687ba39de
        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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        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          91
          end exclusive
          true
          exact text
          alkylating drug indicated for treatment of
          label id
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          offset unit
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          source array index
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          source text sha256
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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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            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
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            source url
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            spl effective date
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            spl set id
            ace9a43b-f9bd-4896-abfe-0ef4fec67ddf
            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
            tumor_directed_candidate
            Passage 2 · limitation of use
            application numbers
            1. NDA208194
            brand names
            1. Bendeka
            classification reasons
            1. negative_or_not_established_clause
            clinical review status
            pending
            content role
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            context span
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            433
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leuke
            label id
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            duplicate text group
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            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. BENDAMUSTINE HYDROCHLORIDE
            id
            ind-span-eb185ca9a4c37848d3fd
            label id
            bcfd315e-9ade-4659-9f1c-dfb687ba39de
            positive predicate support span
            Source null
            qualifier mentions
            1. context exact
              Efficacy relative to first line therapies other than chlorambucil has not been established.
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              exact text
              first line therapies other than chlorambucil has not been established
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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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                end exclusive
                true
                exact text
                Efficacy relative to first line therapies other than chlorambucil has not been established.
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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
                not_applicable
                Passage 3 · unclassified context
                application numbers
                1. NDA208194
                brand names
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                classification reasons
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                clinical review status
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                content role
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                end exclusive
                true
                exact text
                jection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambuci
                label id
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                offset unit
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                current approval status
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                extraction review status
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                label id
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                positive predicate support span
                Source null
                qualifier mentions
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                      exact text
                      ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
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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
                      unclear
                      Passage 4 · unclassified context
                      application numbers
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                      brand names
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                      classification reasons
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                      clinical review status
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                      content role
                      unclassified_context
                      context span
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                      603
                      end exclusive
                      true
                      exact text
                      hlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has no
                      label id
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                      offset unit
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                      source array index
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                                            Preserved source evidence · Not medical advice