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LABELS · 6c0bc00a-dd5f-4305-85d6-bd534e947e32

BENDAMUSTINE HYDROCHLORIDE

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
2026-05-14
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 Bendamustine Hydrochloride Injection is an alkylating drug indicated for treatment of adult 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) Bendamustine Hydrochloride Injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) Bendamustine Hydrochloride Injection is indicated for the treatment of adult 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. NDA219014
boxed warning exact
    brand names
    1. BENDAMUSTINE HYDROCHLORIDE
    current indication status
    not_reconciled
    dailymed set url
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    generic names
    1. BENDAMUSTINE HYDROCHLORIDE
    id
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    indications and usage exact
    1. 1 INDICATIONS AND USAGE Bendamustine Hydrochloride Injection is an alkylating drug indicated for treatment of adult 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) Bendamustine Hydrochloride Injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) Bendamustine Hydrochloride Injection is indicated for the treatment of adult 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. Avyxa Pharma, LLC
      matched search terms
      1. lymphoma
      2. leukemia
      package ndcs
      1. 83831-183-04
      product ndcs
      1. 83831-183
      product types
      1. HUMAN PRESCRIPTION DRUG
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        1. BENDAMUSTINE HYDROCHLORIDE
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        1. application number
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          payload
          all indexed label documents
          1. Appl No
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            Application Docs Date
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            Application Docs ID
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          all submission records
          1. Appl No
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            Submission Class Code ID
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            Submission No
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            Submissions Public Notes
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          products
          1. Active Ingredient
            BENDAMUSTINE HYDROCHLORIDE
            Appl No
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            Drug Name
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            Form
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            Product No
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            Reference Drug
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            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.

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        1 INDICATIONS AND USAGE Bendamustine Hydrochloride Injection is an alkylating drug indicated for treatment of adult 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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            1 INDICATIONS AND USAGE Bendamustine Hydrochloride Injection is an alkylating drug indicated for treatment of adult 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
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                              e Hydrochloride Injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia.
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                                1.1 Chronic Lymphocytic Leukemia (CLL) Bendamustine Hydrochloride Injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia.
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                                disease stage
                                Source null
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                                Source null
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                                brand names
                                1. BENDAMUSTINE HYDROCHLORIDE
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                                a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) Bendamustine Hydrochloride Injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) Bendamustine Hydrochloride Injection is indicated for the treatment of adult patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six
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                                  Efficacy relative to first line therapies other than chlorambucil has not been established.
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                                    Efficacy relative to first line therapies other than chlorambucil has not been established.
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                                    Source null
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                                    Source null
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                                    Source null
                                    limitations
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                                    prior therapy
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                                    regimen
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                                    Passage 7 · positive indication candidate
                                    application numbers
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                                    brand names
                                    1. BENDAMUSTINE HYDROCHLORIDE
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                                    Hydrochloride Injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) Bendamustine Hydrochloride Injection is indicated for the treatment of adult 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.
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                                    1. BENDAMUSTINE HYDROCHLORIDE
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                                      e Hydrochloride Injection is indicated for the treatment of adult patients with indolent B-cell non-Hodgkin lymphoma that has progress
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                                        1.2 Non-Hodgkin Lymphoma (NHL) Bendamustine Hydrochloride Injection is indicated for the treatment of adult 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.
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                                        approval pathway
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                                        biomarker and test
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                                        limitations
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                                        prior therapy
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                                        regimen
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                                        tumor histology
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                                        use intent
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                                        Preserved source evidence · Not medical advice