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LABELS · 2cc294fe-75e3-4ed9-8259-c6e5bc5e8286

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
2021-09-22
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Bortezomib 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 Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
Full extracted label fields
application numbers
  1. NDA215331
boxed warning exact
    brand names
    1. Bortezomib
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c40e6a28-d577-43d4-bca6-bef28da1d580
    generic names
    1. BORTEZOMIB
    id
    2cc294fe-75e3-4ed9-8259-c6e5bc5e8286
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Bortezomib 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 Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib 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. MAIA Pharmaceuticals, Inc.
      matched search terms
      1. lymphoma
      2. myeloma
      package ndcs
      1. 70511-161-05
      2. 70511-162-02
      product ndcs
      1. 70511-161
      2. 70511-162
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 2608948
        2. 2608952
        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
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        url
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        source url
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        spl effective date
        2021-09-22
        spl effective time
        20210922
        spl set id
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        spl version
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        substance names
        1. BORTEZOMIB
        uniis
        1. 69G8BD63PP
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        Drugs@FDA application source records
        1. application number
          NDA215331
          payload
          all indexed label documents
          1. Appl No
            215331
            Application Docs Date
            2022-07-28 00:00:00
            Application Docs ID
            71660
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            215331
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2022-07-27 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA215331
          approval interpretation
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          current indication status
          not_reconciled
          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
            215331
            Application Docs Date
            2022-07-28 00:00:00
            Application Docs ID
            71660
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
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          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          MAIA PHARMS INC
          openfda application present
          true
          products
          1. Active Ingredient
            BORTEZOMIB
            Appl No
            215331
            Drug Name
            BORTEZOMIB
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            3.5MG/3.5ML (1MG/ML)
            marketing status
            1. Discontinued
          2. Active Ingredient
            BORTEZOMIB
            Appl No
            215331
            Drug Name
            BORTEZOMIB
            Form
            SOLUTION;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            3.5MG/1.4ML (2.5MG/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. NDA215331
        brand names
        1. Bortezomib
        classification reasons
        1. explicit_positive_indication_predicate
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        clinical review status
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        exact text
        1 INDICATIONS AND USAGE Bortezomib 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 Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib Injection is indicated for the treatment of adult
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        is a proteasome inhibitor indicated
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        qualifier mentions
        1. context exact
          ction is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma (1.1) treatment of adult patients wit
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            1 INDICATIONS AND USAGE Bortezomib 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)
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            biomarker and test
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            Source null
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            Source null
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            Source null
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            Source null
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            Passage 2 · positive indication candidate
            application numbers
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            brand names
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            INDICATIONS AND USAGE Bortezomib 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 Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
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              loma Bortezomib Injection is indicated for the treatment of adult patients with multiple myeloma.
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                1.1 Multiple Myeloma Bortezomib Injection is indicated for the treatment of adult patients with multiple myeloma.
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                Passage 3 · positive indication candidate
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                th multiple myeloma (1.1) treatment of adult patients with mantle cell lymphoma (1.2) 1.1 Multiple Myeloma Bortezomib Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
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                    1.2 Mantle Cell Lymphoma Bortezomib Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
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                    Preserved source evidence · Not medical advice