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LABELS · e7c31651-e301-43f9-bc81-e0fd5dcb828c

BORTEZOMIB

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
2023-02-27
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Bortezomib for Injection is a proteasome inhibitor indicated for: • Treatment of adult patients with multiple myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
Full extracted label fields
application numbers
  1. NDA209191
boxed warning exact
    brand names
    1. BORTEZOMIB
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fdf6169-699f-40eb-bda1-760253062b3c
    generic names
    1. BORTEZOMIB
    id
    e7c31651-e301-43f9-bc81-e0fd5dcb828c
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Bortezomib for Injection is a proteasome inhibitor indicated for: • Treatment of adult patients with multiple myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Hospira, Inc.
      matched search terms
      1. lymphoma
      2. myeloma
      package ndcs
      1. 0409-1703-01
      2. 0409-1704-01
      product ndcs
      1. 0409-1703
      2. 0409-1704
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage, Mantle Cell Lymphoma ( 1.2 ), Removed phrase “who have received at least 1 prior therapy” 12/2022 Dosage and Administration ( 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 , 2.10 ) 12/2022 Warnings and Precautions, Thrombocytopenia/Neutropenia ( 5.7 ) 12/2022
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      2. SUBCUTANEOUS
      rxcuis
      1. 2601542
      2. 2601544
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00700.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
      700
      total
      830
      sha256
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      url
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      source url
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      spl effective date
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      spl effective time
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      substance names
      1. BORTEZOMIB
      uniis
      1. 69G8BD63PP
      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
        NDA209191
        payload
        all indexed label documents
        1. Appl No
          209191
          Application Docs Date
          2022-05-04 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
          209191
          Application Docs Date
          2022-12-12 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        all submission records
        1. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2022-05-02 00:00:00
          Submission Type
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          Submissions Public Notes
        2. Appl No
          209191
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
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          Submission Status Date
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          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
        true
        latest approved submission date
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        latest label selection rule
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        latest posted label documents
        1. Appl No
          209191
          Application Docs Date
          2022-12-12 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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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        HOSPIRA
        openfda application present
        true
        products
        1. Active Ingredient
          BORTEZOMIB
          Appl No
          209191
          Drug Name
          BORTEZOMIB
          Form
          POWDER;INTRAVENOUS, SUBCUTANEOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          1MG/VIAL
          marketing status
          1. Prescription
        2. Active Ingredient
          BORTEZOMIB
          Appl No
          209191
          Drug Name
          BORTEZOMIB
          Form
          POWDER;INTRAVENOUS, SUBCUTANEOUS
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          2.5MG/VIAL
          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 · indication intro context
      application numbers
      1. NDA209191
      brand names
      1. BORTEZOMIB
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      exact text
      1 INDICATIONS AND USAGE Bortezomib for Injection is a proteasome inhibitor indicated for: • Treatment of adult patients with multiple myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatm
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      is a proteasome inhibitor indicated
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            1 INDICATIONS AND USAGE Bortezomib for Injection is a proteasome inhibitor indicated for:
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            1 INDICATIONS AND USAGE Bortezomib for Injection is a proteasome inhibitor indicated for: • Treatment of adult patients with multiple myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mant
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            is a proteasome inhibitor indicated
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                Source null
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                1 INDICATIONS AND USAGE Bortezomib for Injection is a proteasome inhibitor indicated for: • Treatment of adult patients with multiple myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell
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                      1 INDICATIONS AND USAGE Bortezomib for Injection is a proteasome inhibitor indicated for: • Treatment of adult patients with multiple myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the tr
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                          TIONS AND USAGE Bortezomib for Injection is a proteasome inhibitor indicated for: • Treatment of adult patients with multiple myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the treatment
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                                D USAGE Bortezomib for Injection is a proteasome inhibitor indicated for: • Treatment of adult patients with multiple myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
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                                    1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma.
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                                    myeloma. ( 1.1 ) • Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
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                                        Preserved source evidence · Not medical advice