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LABELS · 120a3a37-e84a-406b-94f8-243897706dc6

TABLOID

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
2025-01-08
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients. Reliance upon thioguanine alone is seldom justified for initial remission induction of acute nonlymphocytic leukemias because combination chemotherapy including thioguanine results in more frequent remission induction and longer duration of remission than thioguanine alone. b) Other Neoplasms TABLOID brand Thioguanine is not effective in chronic lymphocytic leukemia, Hodgkin’s lymphoma, multiple myeloma, or solid tumors. Although thioguanine is one of several agents with activity in the treatment of the chronic phase of chronic myelogenous leukemia, more objective responses are observed with MYLERAN ® (busulfan), and therefore busulfan is usually regarded as the preferred drug.
Full extracted label fields
application numbers
  1. NDA012429
boxed warning exact
    brand names
    1. TABLOID
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=44b0c461-47fb-4106-ba11-6ed85530235c
    generic names
    1. THIOGUANINE
    id
    120a3a37-e84a-406b-94f8-243897706dc6
    indications and usage exact
    1. INDICATIONS AND USAGE a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients. Reliance upon thioguanine alone is seldom justified for initial remission induction of acute nonlymphocytic leukemias because combination chemotherapy including thioguanine results in more frequent remission induction and longer duration of remission than thioguanine alone. b) Other Neoplasms TABLOID brand Thioguanine is not effective in chronic lymphocytic leukemia, Hodgkin’s lymphoma, multiple myeloma, or solid tumors. Although thioguanine is one of several agents with activity in the treatment of the chronic phase of chronic myelogenous leukemia, more objective responses are observed with MYLERAN ® (busulfan), and therefore busulfan is usually regarded as the preferred drug.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Waylis Therapeutics LLC
      matched search terms
      1. lymphoma
      2. leukemia
      3. myeloma
      4. tumors
      5. neoplasms
      package ndcs
      1. 80725-630-25
      product ndcs
      1. 80725-630
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 105590
        2. 198269
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.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
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        skip
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        830
        sha256
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        url
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        source url
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        spl effective date
        2025-01-08
        spl effective time
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        spl version
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        substance names
        1. THIOGUANINE
        uniis
        1. FTK8U1GZNX
        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
          NDA012429
          payload
          all indexed label documents
          1. Appl No
            012429
            Application Docs Date
            2003-07-08 00:00:00
            Application Docs ID
            10810
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          2. Appl No
            012429
            Application Docs Date
            2003-12-29 00:00:00
            Application Docs ID
            10811
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            21
            Submission Type
            SUPPL
          3. Appl No
            012429
            Application Docs Date
            2004-11-16 00:00:00
            Application Docs ID
            10812
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            22
            Submission Type
            SUPPL
          4. Appl No
            012429
            Application Docs Date
            2018-05-25 00:00:00
            Application Docs ID
            54342
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            28
            Submission Type
            SUPPL
          5. Appl No
            012429
            Application Docs Date
            2024-07-12 00:00:00
            Application Docs ID
            79053
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            012429
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1966-01-18 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            012429
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            1977-02-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            012429
            Review Priority
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            1978-08-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            012429
            Review Priority
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            1984-03-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            012429
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            1985-08-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            012429
            Review Priority
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            1985-11-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            012429
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            1988-07-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            012429
            Review Priority
            Submission Class Code ID
            3
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            1986-09-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            012429
            Review Priority
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            1987-04-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            012429
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            1990-04-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            012429
            Review Priority
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            1991-07-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            012429
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2001-12-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA012429
          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
          2024-07-09
          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
            012429
            Application Docs Date
            2024-07-12 00:00:00
            Application Docs ID
            79053
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          official application record
          Appl No
          012429
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          WAYLIS THERAP
          openfda application present
          true
          products
          1. Active Ingredient
            THIOGUANINE
            Appl No
            012429
            Drug Name
            THIOGUANINE
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            40MG
            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. NDA012429
        brand names
        1. TABLOID
        classification reasons
        1. explicit_positive_indication_predicate
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        clinical review status
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        true
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        INDICATIONS AND USAGE a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). The response
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              INDICATIONS AND USAGE a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias.
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              spl effective date
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              use intent
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              Passage 2 · limitation of use
              application numbers
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              INDICATIONS AND USAGE a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients. Reli
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                    However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS).
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                    ic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients. Reliance upon thioguanine alone is seldom justified for initial remission induction of acute nonlymphocytic leukemias because combination chemotherapy including thioguanine results in more frequent r
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                        The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients.
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                        NS). The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients. Reliance upon thioguanine alone is seldom justified for initial remission induction of acute nonlymphocytic leukemias because combination chemotherapy including thioguanine results in more frequent remission induction and longer duration of remission than thioguanine alone. b) Other Neoplasms TABLOID brand Thioguanine is not effective in chronic lymphocytic leukemia, Hodgkin’s lymphoma, multiple myeloma, or solid tumors. Although thioguanine is one of several agents with activity in the treatment of the chronic phase of chronic myelogenous leukemia, more objective responses are observed with MYLERAN ® (busulfan), and
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                              Reliance upon thioguanine alone is seldom justified for initial remission induction of acute nonlymphocytic leukemias because combination chemotherapy including thioguanine results in more frequent remission induction and longer duration of remission than thioguanine alone. b) Other Neoplasms TABLOID brand Thioguanine is not effective in chronic lymphocytic leukemia, Hodgkin’s lymphoma, multiple myeloma, or solid tumors.
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                              ger duration of remission than thioguanine alone. b) Other Neoplasms TABLOID brand Thioguanine is not effective in chronic lymphocytic leukemia, Hodgkin’s lymphoma, multiple myeloma, or solid tumors. Although thioguanine is one of several agents with activity in the treatment of the chronic phase of chronic myelogenous leukemia, more objective responses are observed with MYLERAN ® (busulfan), and therefore busulfan is usually regarded as the preferred drug.
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                                    Although thioguanine is one of several agents with activity in the treatment of the chronic phase of chronic myelogenous leukemia, more objective responses are observed with MYLERAN ® (busulfan), and therefore busulfan is usually regarded as the preferred drug.
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                                    Preserved source evidence · Not medical advice