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LABELS · 5ebe4a1f-c7d6-95a3-8f21-8deebf9bd43a

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
2025-09-16
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 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. Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with: • 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 )
Full extracted label fields
application numbers
  1. NDA215033
boxed warning exact
    brand names
    1. Bendamustine Hydrochloride
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=085dd54c-4212-d879-afef-ee52732a48c0
    generic names
    1. BENDAMUSTINE HYDROCHLORIDE
    id
    5ebe4a1f-c7d6-95a3-8f21-8deebf9bd43a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE 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. Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with: • 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 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Apotex Corp
      matched search terms
      1. lymphoma
      package ndcs
      1. 60505-6228-0
      product ndcs
      1. 60505-6228
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. RECENT MAJOR CHANGES SECTION Indications and Usage, Chronic Lymphocytic Leukemia (CLL) indication removed ( 1.1 ) 04/2024 Dosage and Administration, Dosing Instructions for CLL removed ( 2.1 ) 04/2024
      record type
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      routes
      1. INTRAVENOUS
      rxcuis
      1. 1726097
      source batch
      file
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      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
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      url
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      source url
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      spl effective date
      2025-09-16
      spl effective time
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      spl set id
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      spl version
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      substance names
      1. BENDAMUSTINE HYDROCHLORIDE
      uniis
      1. 981Y8SX18M
      verification flags
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      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA215033
        payload
        all indexed label documents
        1. Appl No
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          Application Docs Date
          2022-12-09 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          Submission Type
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        2. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          3
          Submission Type
          SUPPL
        all submission records
        1. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2024-04-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
          15
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2022-12-07 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
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        approval interpretation
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        current indication status
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        has approved submission record
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        latest approved submission date
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        latest label selection rule
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        latest posted label documents
        1. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        APOTEX
        openfda application present
        true
        products
        1. Active Ingredient
          BENDAMUSTINE HYDROCHLORIDE
          Appl No
          215033
          Drug Name
          BENDAMUSTINE HYDROCHLORIDE
          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. NDA215033
      brand names
      1. Bendamustine Hydrochloride
      classification reasons
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      clinical review status
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      content role
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      context span
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      489
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE 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. Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with: • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months
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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
        kind
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          1 INDICATIONS AND USAGE 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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          biomarker and test
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          limitations
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          Source null
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          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. Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with: • 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 )
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          is an alkylating drug indicated
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            injection is an alkylating drug indicated for treatment of adult patients with:
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          2. context exact
            Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with:
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            exact text
            alkylating drug indicated for treatment of
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              Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with:
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              d during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with: • 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 )
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                    cated for treatment of adult patients with: • 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 )
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                          Preserved source evidence · Not medical advice