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LABELS · 25cb4a4a-e28a-c674-e063-6294a90a0bdd

Valstar

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
2024-10-31
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 VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )
Full extracted label fields
application numbers
  1. NDA020892
boxed warning exact
    brand names
    1. Valstar
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e96f30a0-6662-11de-8f80-0002a5d5c51b
    generic names
    1. VALRUBICIN
    id
    25cb4a4a-e28a-c674-e063-6294a90a0bdd
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Endo USA, Inc.
      matched search terms
      1. carcinoma
      package ndcs
      1. 67979-001-01
      product ndcs
      1. 67979-001
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
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        routes
        1. INTRAVESICAL
        rxcuis
        1. 262063
        2. 313567
        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
        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
        2024-10-31
        spl effective time
        20241031
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        spl version
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        substance names
        1. VALRUBICIN
        uniis
        1. 2C6NUM6878
        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
          NDA020892
          payload
          all indexed label documents
          1. Appl No
            020892
            Application Docs Date
            1998-09-25 00:00:00
            Application Docs ID
            13673
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            020892
            Application Docs Date
            2011-11-04 00:00:00
            Application Docs ID
            13674
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          3. Appl No
            020892
            Application Docs Date
            2016-04-08 00:00:00
            Application Docs ID
            35576
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020892
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1998-09-25 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            020892
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1999-08-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020892
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2001-04-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020892
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2011-11-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020892
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2012-12-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020892
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2013-08-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            020892
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2013-11-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020892
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2014-01-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            020892
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2016-04-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020892
          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
          2016-04-07
          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
            020892
            Application Docs Date
            2016-04-08 00:00:00
            Application Docs ID
            35576
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
            19
            Submission Type
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          official application record
          Appl No
          020892
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ENDO OPERATIONS
          openfda application present
          true
          products
          1. Active Ingredient
            VALRUBICIN
            Appl No
            020892
            Drug Name
            VALSTAR PRESERVATIVE FREE
            Form
            SOLUTION;INTRAVESICAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            40MG/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
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        true
        exact text
        1 INDICATIONS AND USAGE VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would
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        qualifier mentions
        1. context exact
          omerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would
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            1 INDICATIONS AND USAGE VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
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            spl effective date
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            structured fields status
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            cated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )
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            is an anthracycline topoisomerase inhibitor indicated
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            qualifier mentions
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                VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
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                cated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )
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                      Preserved source evidence · Not medical advice