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LABELS · 71ebcbb5-31e2-4394-8a38-d833fd3c733a

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
2024-08-30
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 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. NDA212782
boxed warning exact
    brand names
    1. Bortezomib
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=61539d49-dc21-4576-8813-4bc8abf3868c
    generic names
    1. BORTEZOMIB
    id
    71ebcbb5-31e2-4394-8a38-d833fd3c733a
    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. Shilpa Medicare Limited
      matched search terms
      1. lymphoma
      2. myeloma
      package ndcs
      1. 63759-3032-1
      product ndcs
      1. 63759-3032
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        routes
        1. INTRAVENOUS
        2. SUBCUTANEOUS
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        1. 2608948
        source batch
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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
        2024-08-30
        spl effective time
        20240830
        spl set id
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        spl version
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        substance names
        1. BORTEZOMIB
        uniis
        1. 69G8BD63PP
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          NDA212782
          payload
          all indexed label documents
          1. Appl No
            212782
            Application Docs Date
            2024-08-29 00:00:00
            Application Docs ID
            79496
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            212782
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2024-08-26 00:00:00
            Submission Type
            ORIG
            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
            212782
            Application Docs Date
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            Application Docs ID
            79496
            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
          SHILPA
          openfda application present
          true
          products
          1. Active Ingredient
            BORTEZOMIB
            Appl No
            212782
            Drug Name
            BORTEZOMIB
            Form
            SOLUTION;INTRAVENOUS, SUBCUTANEOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            3.5MG/1.4ML (2.5MG/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. NDA212782
        brand names
        1. Bortezomib
        classification reasons
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        clinical review status
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        content role
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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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        1. context exact
          ction is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients w
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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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            Passage 2 · positive indication candidate
            application numbers
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            CATIONS 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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            qualifier mentions
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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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                source url
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                Passage 3 · positive indication candidate
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                ultiple 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