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LABELS · 77ae475d-2d59-4fe2-8de7-833b6fc9d51a

TREANDA

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
2022-10-27
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TREANDA 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) TREANDA ® 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) TREANDA 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. NDA022249
boxed warning exact
    brand names
    1. TREANDA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d53698-57fa-7c99-fc5b-f52a55684826
    generic names
    1. BENDAMUSTINE HYDROCHLORIDE
    id
    77ae475d-2d59-4fe2-8de7-833b6fc9d51a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TREANDA 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) TREANDA ® 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) TREANDA 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. Cephalon, LLC
      matched search terms
      1. lymphoma
      2. leukemia
      package ndcs
      1. 63459-395-02
      2. 63459-396-02
      3. 63459-390-08
      4. 63459-391-20
      product ndcs
      1. 63459-390
      2. 63459-395
      3. 63459-396
      4. 63459-391
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1805001
        2. 1805004
        3. 1805007
        4. 1805009
        5. 1805011
        6. 1805012
        7. 1805015
        8. 1805016
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00400.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
        400
        total
        830
        sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        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=400&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2277ae475d-2d59-4fe2-8de7-833b6fc9d51a%22
        spl effective date
        2022-10-27
        spl effective time
        20221027
        spl set id
        39d53698-57fa-7c99-fc5b-f52a55684826
        spl version
        26
        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          NDA022249
          payload
          all indexed label documents
          1. Appl No
            022249
            Application Docs Date
            2010-03-03 00:00:00
            Application Docs ID
            17117
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          2. Appl No
            022249
            Application Docs Date
            2012-06-27 00:00:00
            Application Docs ID
            17118
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          3. Appl No
            022249
            Application Docs Date
            2013-08-29 00:00:00
            Application Docs ID
            17119
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          4. Appl No
            022249
            Application Docs Date
            2013-09-17 00:00:00
            Application Docs ID
            17120
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          5. Appl No
            022249
            Application Docs Date
            2008-03-20 00:00:00
            Application Docs ID
            38417
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          6. Appl No
            022249
            Application Docs Date
            2009-05-11 00:00:00
            Application Docs ID
            38418
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          7. Appl No
            022249
            Application Docs Date
            2009-04-28 00:00:00
            Application Docs ID
            38419
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          8. Appl No
            022249
            Application Docs Date
            2010-12-26 00:00:00
            Application Docs ID
            38420
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          9. Appl No
            022249
            Application Docs Date
            2015-03-10 00:00:00
            Application Docs ID
            38421
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          10. Appl No
            022249
            Application Docs Date
            2015-11-12 00:00:00
            Application Docs ID
            38422
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          11. Appl No
            022249
            Application Docs Date
            2015-09-02 00:00:00
            Application Docs ID
            38423
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            21
            Submission Type
            SUPPL
          12. Appl No
            022249
            Application Docs Date
            2016-10-19 00:00:00
            Application Docs ID
            45906
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            22
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2022-10-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2021-06-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2019-11-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            2017-12-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            2016-10-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2015-09-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2015-11-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2015-03-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            022249
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2015-07-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            022249
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2014-03-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            022249
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2013-09-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            022249
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2013-08-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA022249
          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
          2022-10-25
          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
            022249
            Application Docs Date
            2022-11-03 00:00:00
            Application Docs ID
            72557
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          official application record
          Appl No
          022249
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          CEPHALON
          openfda application present
          true
          products
          1. Active Ingredient
            BENDAMUSTINE HYDROCHLORIDE
            Appl No
            022249
            Drug Name
            TREANDA
            Form
            POWDER;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            100MG/VIAL
            marketing status
            1. Prescription
          2. Active Ingredient
            BENDAMUSTINE HYDROCHLORIDE
            Appl No
            022249
            Drug Name
            TREANDA
            Form
            POWDER;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            25MG/VIAL
            marketing status
            1. Prescription
          3. Active Ingredient
            BENDAMUSTINE HYDROCHLORIDE
            Appl No
            022249
            Drug Name
            TREANDA
            Form
            SOLUTION;INTRAVENOUS
            Product No
            003
            Reference Drug
            1
            Reference Standard
            0
            Strength
            45MG/0.5ML (90MG/ML)
            marketing status
            1. Discontinued
          4. Active Ingredient
            BENDAMUSTINE HYDROCHLORIDE
            Appl No
            022249
            Drug Name
            TREANDA
            Form
            SOLUTION;INTRAVENOUS
            Product No
            004
            Reference Drug
            1
            Reference Standard
            0
            Strength
            180MG/2ML (90MG/ML)
            marketing status
            1. Discontinued

        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. NDA022249
        brand names
        1. TREANDA
        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
        331
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE TREANDA 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
        label id
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        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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        current approval status
        not_reconciled
        duplicate text group
        dup-45999004297505ace82c
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. BENDAMUSTINE HYDROCHLORIDE
        id
        ind-span-cbc9a261f86e9cf76c4f
        label id
        77ae475d-2d59-4fe2-8de7-833b6fc9d51a
        positive predicate support span
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        end exclusive
        true
        exact text
        is an alkylating drug indicated
        label id
        77ae475d-2d59-4fe2-8de7-833b6fc9d51a
        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 TREANDA is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          81
          end exclusive
          true
          exact text
          alkylating drug indicated for treatment of
          label id
          77ae475d-2d59-4fe2-8de7-833b6fc9d51a
          offset unit
          unicode_code_points
          source array index
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          source field
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          source text sha256
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          start
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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
            source span
            end
            131
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE TREANDA is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
            label id
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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%2277ae475d-2d59-4fe2-8de7-833b6fc9d51a%22
            spl effective date
            2022-10-27
            spl set id
            39d53698-57fa-7c99-fc5b-f52a55684826
            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. NDA022249
            brand names
            1. TREANDA
            classification reasons
            1. negative_or_not_established_clause
            clinical review status
            pending
            content role
            limitation_of_use
            context span
            end
            423
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE TREANDA 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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            source text sha256
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            current approval status
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            duplicate text group
            dup-304e02fc3b2e74adc654
            extraction review status
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            generic names
            1. BENDAMUSTINE HYDROCHLORIDE
            id
            ind-span-a804f2a1e84ed4a7c7ba
            label id
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            positive predicate support span
            Source null
            qualifier mentions
            1. context exact
              Efficacy relative to first line therapies other than chlorambucil has not been established.
              kind
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              end exclusive
              true
              exact text
              first line therapies other than chlorambucil has not been established
              label id
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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
                https://api.fda.gov/drug/label.json?search=id%3A%2277ae475d-2d59-4fe2-8de7-833b6fc9d51a%22
                spl effective date
                2022-10-27
                spl set id
                39d53698-57fa-7c99-fc5b-f52a55684826
                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
                not_applicable
                Passage 3 · unclassified context
                application numbers
                1. NDA022249
                brand names
                1. TREANDA
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                585
                end exclusive
                true
                exact text
                TREANDA 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) TREANDA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambuci
                label id
                77ae475d-2d59-4fe2-8de7-833b6fc9d51a
                offset unit
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                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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                current approval status
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                duplicate text group
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                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. BENDAMUSTINE HYDROCHLORIDE
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                                            Preserved source evidence · Not medical advice