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LABELS · 27d99e44-bbc6-445d-b08b-e32fd8702dc3

ZOLINZA

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
2024-11-12
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 ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. ( 1 )
Full extracted label fields
application numbers
  1. NDA021991
boxed warning exact
    brand names
    1. ZOLINZA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd86ee78-2781-468b-930c-3c4677bcc092
    generic names
    1. VORINOSTAT
    id
    27d99e44-bbc6-445d-b08b-e32fd8702dc3
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Merck Sharp & Dohme LLC
      matched search terms
      1. lymphoma
      package ndcs
      1. 0006-0568-40
      product ndcs
      1. 0006-0568
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 668579
        2. 668606
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2024-11-12
        spl effective time
        20241112
        spl set id
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        spl version
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        substance names
        1. VORINOSTAT
        uniis
        1. 58IFB293JI
        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
          NDA021991
          payload
          all indexed label documents
          1. Appl No
            021991
            Application Docs Date
            2006-10-11 00:00:00
            Application Docs ID
            16703
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            021991
            Application Docs Date
            2008-07-23 00:00:00
            Application Docs ID
            16704
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            021991
            Application Docs Date
            2011-11-15 00:00:00
            Application Docs ID
            38012
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          4. Appl No
            021991
            Application Docs Date
            2009-10-01 00:00:00
            Application Docs ID
            38013
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          5. Appl No
            021991
            Application Docs Date
            2018-12-12 00:00:00
            Application Docs ID
            56711
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            021991
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2006-10-06 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            021991
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2008-07-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            021991
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2011-11-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            021991
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2009-09-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            021991
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2011-06-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            021991
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2013-04-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            021991
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2015-10-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            021991
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2015-12-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            021991
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2018-12-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA021991
          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
          2018-12-11
          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
            021991
            Application Docs Date
            2018-12-12 00:00:00
            Application Docs ID
            56711
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          official application record
          Appl No
          021991
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          MSD SUB MERCK
          openfda application present
          true
          products
          1. Active Ingredient
            VORINOSTAT
            Appl No
            021991
            Drug Name
            ZOLINZA
            Form
            CAPSULE;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            100MG
            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. NDA021991
        brand names
        1. ZOLINZA
        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
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        429
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurre
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        qualifier mentions
        1. context exact
          taneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.
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          stage_or_setting
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          not_inferred
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          end
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          exact text
          recurrent disease on or following two system
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            true
            exact text
            1 INDICATIONS AND USAGE ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.
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            source url
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            spl effective date
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            spl set id
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            structured fields status
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            biomarker and test
            Source null
            disease stage
            Source null
            limitations
            Source null
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            Source null
            prior therapy
            Source null
            regimen
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            tumor histology
            Source null
            use intent
            tumor_directed_candidate
            Passage 2 · positive indication candidate
            application numbers
            1. NDA021991
            brand names
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            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
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            485
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            true
            exact text
            A ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. ( 1 )
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            generic names
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            true
            exact text
            is a histone deacetylase (HDAC) inhibitor indicated
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            qualifier mentions
            1. context exact
              T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
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              stage_or_setting
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              recurrent disease on or following two system
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                ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
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                source url
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                spl effective date
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                regimen
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                indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. ( 1 )
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                      use intent
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                      Preserved source evidence · Not medical advice