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LABELS · 80829f8c-c5ee-4e37-b5af-1b0e4e4dd5bd

Agrylin

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
2026-04-08
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 AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. AGRYLIN is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. ( 1 )
Full extracted label fields
application numbers
  1. NDA020333
boxed warning exact
    brand names
    1. Agrylin
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cb960074-99c1-4a73-941f-f0644a7ec219
    generic names
    1. ANAGRELIDE HYDROCHLORIDE
    id
    80829f8c-c5ee-4e37-b5af-1b0e4e4dd5bd
    indications and usage exact
    1. 1 INDICATIONS AND USAGE AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. AGRYLIN is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Takeda Pharmaceuticals America, Inc.
      matched search terms
      1. neoplasms
      2. myeloproliferative
      3. thrombocythemia
      package ndcs
      1. 54092-063-01
      product ndcs
      1. 54092-063
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 597850
        2. 597857
        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
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        skip
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        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2026-04-08
        spl effective time
        20260408
        spl set id
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        spl version
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        substance names
        1. ANAGRELIDE HYDROCHLORIDE ANHYDROUS
        uniis
        1. VNS4435G39
        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
          NDA020333
          payload
          all indexed label documents
          1. Appl No
            020333
            Application Docs Date
            1998-12-16 00:00:00
            Application Docs ID
            12455
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          2. Appl No
            020333
            Application Docs Date
            2004-12-10 00:00:00
            Application Docs ID
            12456
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          3. Appl No
            020333
            Application Docs Date
            2004-12-30 00:00:00
            Application Docs ID
            12457
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          4. Appl No
            020333
            Application Docs Date
            2008-06-19 00:00:00
            Application Docs ID
            12458
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          5. Appl No
            020333
            Application Docs Date
            2011-01-31 00:00:00
            Application Docs ID
            12459
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          6. Appl No
            020333
            Application Docs Date
            2011-11-30 00:00:00
            Application Docs ID
            12460
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          7. Appl No
            020333
            Application Docs Date
            2014-11-04 00:00:00
            Application Docs ID
            12461
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            22
            Submission Type
            SUPPL
          8. Appl No
            020333
            Application Docs Date
            2015-07-16 00:00:00
            Application Docs ID
            12462
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            23
            Submission Type
            SUPPL
          9. Appl No
            020333
            Application Docs Date
            2004-12-10 00:00:00
            Application Docs ID
            34513
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          10. Appl No
            020333
            Application Docs Date
            2009-07-23 00:00:00
            Application Docs ID
            34514
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          11. Appl No
            020333
            Application Docs Date
            2010-07-06 00:00:00
            Application Docs ID
            34515
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          12. Appl No
            020333
            Application Docs Date
            2013-07-23 00:00:00
            Application Docs ID
            34516
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2021-10-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2020-02-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2018-12-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2018-03-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            2015-07-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            2014-10-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2014-02-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2013-07-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2011-11-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            020333
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2011-01-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            020333
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2010-06-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            020333
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2009-07-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020333
          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
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          latest label selection rule
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          latest posted label documents
          1. Appl No
            020333
            Application Docs Date
            2021-10-14 00:00:00
            Application Docs ID
            68993
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            27
            Submission Type
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          official application record
          Appl No
          020333
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          TAKEDA PHARMS USA
          openfda application present
          true
          products
          1. Active Ingredient
            ANAGRELIDE HYDROCHLORIDE
            Appl No
            020333
            Drug Name
            AGRYLIN
            Form
            CAPSULE;ORAL
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            EQ 0.5MG BASE
            marketing status
            1. Prescription
          2. Active Ingredient
            ANAGRELIDE HYDROCHLORIDE
            Appl No
            020333
            Drug Name
            AGRYLIN
            Form
            CAPSULE;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
            marketing status
            1. Discontinued

        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
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        brand names
        1. Agrylin
        classification reasons
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        clinical review status
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        context span
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        true
        exact text
        1 INDICATIONS AND USAGE AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. AGRYLIN is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to
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              1 INDICATIONS AND USAGE AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.
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              hrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. AGRYLIN is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. ( 1 )
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                          Preserved source evidence · Not medical advice