Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 3ec85e73-696a-4a2e-aa24-656c6341b23b

VELCADE

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
2025-08-28
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VELCADE 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 VELCADE is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle cell lymphoma.
Full extracted label fields
application numbers
  1. NDA021602
boxed warning exact
    brand names
    1. VELCADE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1521d321-e724-4ffc-adad-34bf4f44fac7
    generic names
    1. BORTEZOMIB
    id
    3ec85e73-696a-4a2e-aa24-656c6341b23b
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VELCADE 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 VELCADE is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma VELCADE 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. Takeda Pharmaceuticals America, Inc.
      matched search terms
      1. lymphoma
      2. myeloma
      package ndcs
      1. 63020-049-01
      product ndcs
      1. 63020-049
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        2. SUBCUTANEOUS
        rxcuis
        1. 402243
        2. 402244
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00200.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
        200
        total
        830
        sha256
        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
        url
        https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=200&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%223ec85e73-696a-4a2e-aa24-656c6341b23b%22
        spl effective date
        2025-08-28
        spl effective time
        20250828
        spl set id
        1521d321-e724-4ffc-adad-34bf4f44fac7
        spl version
        36
        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
        3. individual_indications_not_split_or_reconciled
        Drugs@FDA application source records
        1. application number
          NDA021602
          payload
          all indexed label documents
          1. Appl No
            021602
            Application Docs Date
            2006-12-08 00:00:00
            Application Docs ID
            15855
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          2. Appl No
            021602
            Application Docs Date
            2007-10-10 00:00:00
            Application Docs ID
            15856
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          3. Appl No
            021602
            Application Docs Date
            2010-12-04 00:00:00
            Application Docs ID
            15857
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            23
            Submission Type
            SUPPL
          4. Appl No
            021602
            Application Docs Date
            2011-11-04 00:00:00
            Application Docs ID
            15858
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          5. Appl No
            021602
            Application Docs Date
            2012-10-26 00:00:00
            Application Docs ID
            15859
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            31
            Submission Type
            SUPPL
          6. Appl No
            021602
            Application Docs Date
            2014-08-12 00:00:00
            Application Docs ID
            15860
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            38
            Submission Type
            SUPPL
          7. Appl No
            021602
            Application Docs Date
            2003-05-13 00:00:00
            Application Docs ID
            37316
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          8. Appl No
            021602
            Application Docs Date
            2005-03-25 00:00:00
            Application Docs ID
            37317
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          9. Appl No
            021602
            Application Docs Date
            2006-06-01 00:00:00
            Application Docs ID
            37318
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          10. Appl No
            021602
            Application Docs Date
            2008-06-23 00:00:00
            Application Docs ID
            37319
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          11. Appl No
            021602
            Application Docs Date
            2010-01-12 00:00:00
            Application Docs ID
            37320
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          12. Appl No
            021602
            Application Docs Date
            2010-01-12 00:00:00
            Application Docs ID
            37321
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            021602
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            46
            Submission Status
            AP
            Submission Status Date
            2021-11-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            021602
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            45
            Submission Status
            AP
            Submission Status Date
            2021-10-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            021602
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            44
            Submission Status
            AP
            Submission Status Date
            2019-04-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            021602
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            43
            Submission Status
            AP
            Submission Status Date
            2017-06-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            021602
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            42
            Submission Status
            AP
            Submission Status Date
            2015-09-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            021602
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            41
            Submission Status
            AP
            Submission Status Date
            2015-08-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            021602
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            40
            Submission Status
            AP
            Submission Status Date
            2014-10-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            021602
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            39
            Submission Status
            AP
            Submission Status Date
            2014-09-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            021602
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            38
            Submission Status
            AP
            Submission Status Date
            2014-08-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            021602
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            37
            Submission Status
            AP
            Submission Status Date
            2014-03-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            021602
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            36
            Submission Status
            AP
            Submission Status Date
            2013-08-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            021602
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            35
            Submission Status
            AP
            Submission Status Date
            2013-08-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA021602
          approval interpretation
          Application linkage and approved submission are not indication-level current approval verification
          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
          2021-11-04
          latest label selection rule
          max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
          latest posted label documents
          1. Appl No
            021602
            Application Docs Date
            2021-11-05 00:00:00
            Application Docs ID
            69260
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            46
            Submission Type
            SUPPL
          official application record
          Appl No
          021602
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          TAKEDA PHARMS USA
          openfda application present
          true
          products
          1. Active Ingredient
            BORTEZOMIB
            Appl No
            021602
            Drug Name
            VELCADE
            Form
            INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            3.5MG/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 · positive indication candidate
        application numbers
        1. NDA021602
        brand names
        1. VELCADE
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        392
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE VELCADE 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 VELCADE is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle cell
        label id
        3ec85e73-696a-4a2e-aa24-656c6341b23b
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-f00b7ed21396c147ae70
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. BORTEZOMIB
        id
        ind-span-747f8b515f338ba4a9a6
        label id
        3ec85e73-696a-4a2e-aa24-656c6341b23b
        positive predicate support span
        end
        67
        end exclusive
        true
        exact text
        is a proteasome inhibitor indicated
        label id
        3ec85e73-696a-4a2e-aa24-656c6341b23b
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
        start
        32
        qualifier mentions
        1. context exact
          LCADE is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients w
          kind
          age
          polarity
          not_inferred
          span
          end
          100
          end exclusive
          true
          exact text
          adult patients
          label id
          3ec85e73-696a-4a2e-aa24-656c6341b23b
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
          start
          86
        2. context exact
          f adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 )
          kind
          age
          polarity
          not_inferred
          span
          end
          158
          end exclusive
          true
          exact text
          adult patients
          label id
          3ec85e73-696a-4a2e-aa24-656c6341b23b
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
          start
          144
        regulatory links
          schema version
          0.1.0
          source batch sha256
          d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
          source defined aliases
            source span
            end
            192
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE VELCADE 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 )
            label id
            3ec85e73-696a-4a2e-aa24-656c6341b23b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%223ec85e73-696a-4a2e-aa24-656c6341b23b%22
            spl effective date
            2025-08-28
            spl set id
            1521d321-e724-4ffc-adad-34bf4f44fac7
            spl version
            36
            structured fields status
            not_extracted_no_values_inferred_from_mentions
            structured indication
            age
            Source null
            approval pathway
            Source null
            biomarker and test
            Source null
            disease stage
            Source null
            limitations
            Source null
            line
            Source null
            prior therapy
            Source null
            regimen
            Source null
            tumor histology
            Source null
            use intent
            tumor_directed_candidate
            Passage 2 · positive indication candidate
            application numbers
            1. NDA021602
            brand names
            1. VELCADE
            classification reasons
            1. explicit_positive_indication_predicate
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            402
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE VELCADE 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 VELCADE is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle cell lymphoma.
            label id
            3ec85e73-696a-4a2e-aa24-656c6341b23b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-6ee3d4a736e704d559bf
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. BORTEZOMIB
            id
            ind-span-c964bb0ed369b1d4db6d
            label id
            3ec85e73-696a-4a2e-aa24-656c6341b23b
            positive predicate support span
            end
            234
            end exclusive
            true
            exact text
            is indicated
            label id
            3ec85e73-696a-4a2e-aa24-656c6341b23b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
            start
            222
            qualifier mentions
            1. context exact
              Multiple Myeloma VELCADE is indicated for the treatment of adult patients with multiple myeloma.
              kind
              age
              polarity
              not_inferred
              span
              end
              270
              end exclusive
              true
              exact text
              adult patients
              label id
              3ec85e73-696a-4a2e-aa24-656c6341b23b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
              start
              256
            regulatory links
              schema version
              0.1.0
              source batch sha256
              d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
              source defined aliases
                source span
                end
                293
                end exclusive
                true
                exact text
                1.1 Multiple Myeloma VELCADE is indicated for the treatment of adult patients with multiple myeloma.
                label id
                3ec85e73-696a-4a2e-aa24-656c6341b23b
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
                start
                193
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%223ec85e73-696a-4a2e-aa24-656c6341b23b%22
                spl effective date
                2025-08-28
                spl set id
                1521d321-e724-4ffc-adad-34bf4f44fac7
                spl version
                36
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                structured indication
                age
                Source null
                approval pathway
                Source null
                biomarker and test
                Source null
                disease stage
                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
                Source null
                regimen
                Source null
                tumor histology
                Source null
                use intent
                tumor_directed_candidate
                Passage 3 · positive indication candidate
                application numbers
                1. NDA021602
                brand names
                1. VELCADE
                classification reasons
                1. explicit_positive_indication_predicate
                2. tumor_or_malignant_hematology_words_in_positive_statement
                clinical review status
                pending
                content role
                positive_indication_candidate
                context span
                end
                402
                end exclusive
                true
                exact text
                tients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma VELCADE is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle cell lymphoma.
                label id
                3ec85e73-696a-4a2e-aa24-656c6341b23b
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
                start
                94
                current approval status
                not_reconciled
                duplicate text group
                dup-e576141e15a0d211365e
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. BORTEZOMIB
                id
                ind-span-f53d02a20962d6b5fa38
                label id
                3ec85e73-696a-4a2e-aa24-656c6341b23b
                positive predicate support span
                end
                339
                end exclusive
                true
                exact text
                is indicated
                label id
                3ec85e73-696a-4a2e-aa24-656c6341b23b
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
                start
                327
                qualifier mentions
                1. context exact
                  tle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle cell lymphoma.
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  375
                  end exclusive
                  true
                  exact text
                  adult patients
                  label id
                  3ec85e73-696a-4a2e-aa24-656c6341b23b
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
                  start
                  361
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                  source defined aliases
                    source span
                    end
                    402
                    end exclusive
                    true
                    exact text
                    1.2 Mantle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle cell lymphoma.
                    label id
                    3ec85e73-696a-4a2e-aa24-656c6341b23b
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    1735de0df9036d31841d4d9b9ee27c9cc1f4091922b79d81c85582816038e3ed
                    start
                    294
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%223ec85e73-696a-4a2e-aa24-656c6341b23b%22
                    spl effective date
                    2025-08-28
                    spl set id
                    1521d321-e724-4ffc-adad-34bf4f44fac7
                    spl version
                    36
                    structured fields status
                    not_extracted_no_values_inferred_from_mentions
                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    tumor_directed_candidate

                    Preserved source evidence · Not medical advice