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LABELS · d30874b9-8639-44b3-a91b-4fcce90ca484

HYDREA

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
2025-09-15
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE HYDREA is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. HYDREA is an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. ( 1 ) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. ( 1 )
Full extracted label fields
application numbers
  1. NDA016295
boxed warning exact
    brand names
    1. HYDREA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d41152f-a98a-4abc-afdf-a909012434a0
    generic names
    1. HYDROXYUREA
    id
    d30874b9-8639-44b3-a91b-4fcce90ca484
    indications and usage exact
    1. 1 INDICATIONS AND USAGE HYDREA is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. HYDREA is an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. ( 1 ) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Waylis Therapeutics LLC
      matched search terms
      1. carcinomas
      2. leukemia
      package ndcs
      1. 80725-810-10
      product ndcs
      1. 80725-810
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Laboratory Test Interference ( 5.11 ) 11/2023 Drug Interactions, Laboratory Test Interference ( 7.2 ) 11/2023
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 105602
      2. 197797
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00600.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
      600
      total
      830
      sha256
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      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=600&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22d30874b9-8639-44b3-a91b-4fcce90ca484%22
      spl effective date
      2025-09-15
      spl effective time
      20250915
      spl set id
      8d41152f-a98a-4abc-afdf-a909012434a0
      spl version
      1
      substance names
      1. HYDROXYUREA
      uniis
      1. X6Q56QN5QC
      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
        NDA016295
        payload
        all indexed label documents
        1. Appl No
          016295
          Application Docs Date
          2003-07-08 00:00:00
          Application Docs ID
          10878
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          36
          Submission Type
          SUPPL
        2. Appl No
          016295
          Application Docs Date
          2004-04-05 00:00:00
          Application Docs ID
          10879
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          37
          Submission Type
          SUPPL
        3. Appl No
          016295
          Application Docs Date
          2012-01-31 00:00:00
          Application Docs ID
          10880
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          41
          Submission Type
          SUPPL
        4. Appl No
          016295
          Application Docs Date
          2015-07-17 00:00:00
          Application Docs ID
          10881
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          45
          Submission Type
          SUPPL
        5. Appl No
          016295
          Application Docs Date
          2006-09-20 00:00:00
          Application Docs ID
          33153
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          39
          Submission Type
          SUPPL
        6. Appl No
          016295
          Application Docs Date
          2010-05-17 00:00:00
          Application Docs ID
          33154
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          40
          Submission Type
          SUPPL
        7. Appl No
          016295
          Application Docs Date
          2012-01-31 00:00:00
          Application Docs ID
          33155
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          42
          Submission Type
          SUPPL
        8. Appl No
          016295
          Application Docs Date
          2015-07-17 00:00:00
          Application Docs ID
          33156
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          46
          Submission Type
          SUPPL
        9. Appl No
          016295
          Application Docs Date
          2016-03-28 00:00:00
          Application Docs ID
          33157
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          47
          Submission Type
          SUPPL
        10. Appl No
          016295
          Application Docs Date
          2016-03-28 00:00:00
          Application Docs ID
          33158
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          48
          Submission Type
          SUPPL
        11. Appl No
          016295
          Application Docs Date
          2017-12-19 00:00:00
          Application Docs ID
          50772
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          49
          Submission Type
          SUPPL
        12. Appl No
          016295
          Application Docs Date
          2017-12-19 00:00:00
          Application Docs ID
          50773
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          50
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          59
          Submission Status
          AP
          Submission Status Date
          2024-06-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          58
          Submission Status
          AP
          Submission Status Date
          2023-11-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          57
          Submission Status
          AP
          Submission Status Date
          2023-06-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          56
          Submission Status
          AP
          Submission Status Date
          2022-01-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          55
          Submission Status
          AP
          Submission Status Date
          2021-08-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          54
          Submission Status
          AP
          Submission Status Date
          2021-02-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          52
          Submission Status
          AP
          Submission Status Date
          2019-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          51
          Submission Status
          AP
          Submission Status Date
          2019-07-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
          Label for DROXIA includes a Medication Guide
        9. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          50
          Submission Status
          AP
          Submission Status Date
          2017-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          49
          Submission Status
          AP
          Submission Status Date
          2017-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          48
          Submission Status
          AP
          Submission Status Date
          2016-03-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          016295
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          47
          Submission Status
          AP
          Submission Status Date
          2016-03-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA016295
        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
        2024-06-20
        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
          016295
          Application Docs Date
          2024-07-01 00:00:00
          Application Docs ID
          78863
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          59
          Submission Type
          SUPPL
        official application record
        Appl No
        016295
        Appl Public Notes
        Medication Guide is for DROXIA.
        Appl Type
        NDA
        Sponsor Name
        WAYLIS THERAP
        openfda application present
        true
        products
        1. Active Ingredient
          HYDROXYUREA
          Appl No
          016295
          Drug Name
          HYDREA
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          500MG
          marketing status
          1. Prescription
        2. Active Ingredient
          HYDROXYUREA
          Appl No
          016295
          Drug Name
          DROXIA
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          200MG
          marketing status
          1. Prescription
        3. Active Ingredient
          HYDROXYUREA
          Appl No
          016295
          Drug Name
          DROXIA
          Form
          CAPSULE;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          0
          Strength
          300MG
          marketing status
          1. Prescription
        4. Active Ingredient
          HYDROXYUREA
          Appl No
          016295
          Drug Name
          DROXIA
          Form
          CAPSULE;ORAL
          Product No
          004
          Reference Drug
          1
          Reference Standard
          0
          Strength
          400MG
          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. NDA016295
      brand names
      1. HYDREA
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
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      context span
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      301
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE HYDREA is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. HYDREA is an antimetabolite indicated for the treatment of: Resistant chronic my
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            1 INDICATIONS AND USAGE HYDREA is indicated for the treatment of: Resistant chronic myeloid leukemia.
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            Source null
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            Source null
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            Source null
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            Source null
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            Source null
            tumor histology
            Source null
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            tumor_directed_candidate
            Passage 2 · positive indication candidate
            application numbers
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            exact text
            1 INDICATIONS AND USAGE HYDREA is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. HYDREA is an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. ( 1 ) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination wi
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              Locally advanced squamous cell carcinomas of the he
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                Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.
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                GE HYDREA is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. HYDREA is an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. ( 1 ) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. ( 1 )
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                                Preserved source evidence · Not medical advice