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LABELS · d3488fd8-88b2-4f73-9fa4-fbcf14ddd972

Hemady

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
2026-01-09
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 HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 )
Full extracted label fields
application numbers
  1. NDA211379
boxed warning exact
    brand names
    1. Hemady
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b9cf32c-6d60-4853-bbfd-2304ffc2c129
    generic names
    1. DEXAMETHASONE
    id
    d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
    indications and usage exact
    1. 1 INDICATIONS AND USAGE HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Edenbridge Pharmaceuticals LLC.
      matched search terms
      1. myeloma
      package ndcs
      1. 82111-955-01
      2. 82111-955-02
      product ndcs
      1. 82111-955
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Immunosuppression and Increased Risk of Infection ( 5.2 ) 6/2024 Warnings and Precautions, Kaposi’s Sarcoma ( 5.11 ) 6/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2261802
      2. 2286261
      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
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      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%22d3488fd8-88b2-4f73-9fa4-fbcf14ddd972%22
      spl effective date
      2026-01-09
      spl effective time
      20260109
      spl set id
      6b9cf32c-6d60-4853-bbfd-2304ffc2c129
      spl version
      4
      substance names
      1. DEXAMETHASONE
      uniis
      1. 7S5I7G3JQL
      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
        NDA211379
        payload
        all indexed label documents
        1. Appl No
          211379
          Application Docs Date
          2019-10-03 00:00:00
          Application Docs ID
          60220
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          211379
          Application Docs Date
          2021-06-28 00:00:00
          Application Docs ID
          67924
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        3. Appl No
          211379
          Application Docs Date
          2024-06-06 00:00:00
          Application Docs ID
          78669
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          211379
          Review Priority
          STANDARD
          Submission Class Code ID
          26
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2019-10-03 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          211379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2021-06-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          211379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2024-06-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA211379
        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
        2024-06-05
        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
          211379
          Application Docs Date
          2024-06-06 00:00:00
          Application Docs ID
          78669
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        official application record
        Appl No
        211379
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        DEXCEL
        openfda application present
        true
        products
        1. Active Ingredient
          DEXAMETHASONE
          Appl No
          211379
          Drug Name
          HEMADY
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          20MG
          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. NDA211379
      brand names
      1. Hemady
      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
      end
      290
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 )
      label id
      d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-195c6a79be23826056ca
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. DEXAMETHASONE
      id
      ind-span-c398cb34421b74eae3e2
      label id
      d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
      positive predicate support span
      end
      43
      end exclusive
      true
      exact text
      is indicated
      label id
      d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
      start
      31
      qualifier mentions
      1. context exact
        ation with other anti-myeloma products for the treatment of adults with multiple myeloma (MM).
        kind
        age
        polarity
        not_inferred
        span
        end
        119
        end exclusive
        true
        exact text
        adults
        label id
        d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
        start
        113
      2. context exact
        1 INDICATIONS AND USAGE HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM).
        kind
        regimen
        polarity
        not_inferred
        span
        end
        146
        end exclusive
        true
        exact text
        in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM)
        label id
        d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
        start
        44
      regulatory links
        schema version
        0.1.0
        source batch sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        source defined aliases
        1. abbreviation
          MM
          definition exact
          multiple myeloma
          definition span
          end
          146
          end exclusive
          true
          exact text
          multiple myeloma (MM)
          label id
          d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
          start
          125
        source span
        end
        147
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM).
        label id
        d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
        start
        0
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22d3488fd8-88b2-4f73-9fa4-fbcf14ddd972%22
        spl effective date
        2026-01-09
        spl set id
        6b9cf32c-6d60-4853-bbfd-2304ffc2c129
        spl version
        4
        structured fields status
        not_extracted_no_values_inferred_from_mentions
        structured indication
        age
        Source null
        approval pathway
        Source null
        biomarker and test
        Source null
        disease stage
        Source null
        limitations
        Source null
        line
        Source null
        prior therapy
        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
        tumor_directed_candidate
        Passage 2 · positive indication candidate
        application numbers
        1. NDA211379
        brand names
        1. Hemady
        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
        end
        290
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 )
        label id
        d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-969d026b27560ef4e42e
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. DEXAMETHASONE
        id
        ind-span-97e4398b88da61573ab7
        label id
        d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
        positive predicate support span
        end
        184
        end exclusive
        true
        exact text
        is a corticosteroid indicated
        label id
        d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
        start
        155
        qualifier mentions
        1. context exact
          ation with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 )
          kind
          age
          polarity
          not_inferred
          span
          end
          260
          end exclusive
          true
          exact text
          adults
          label id
          d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
          start
          254
        2. context exact
          HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 )
          kind
          regimen
          polarity
          not_inferred
          span
          end
          282
          end exclusive
          true
          exact text
          in combination with other anti-myeloma products for the treatment of adults with multiple myeloma
          label id
          d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
          start
          185
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
          source defined aliases
          1. abbreviation
            MM
            definition exact
            multiple myeloma
            definition span
            end
            146
            end exclusive
            true
            exact text
            multiple myeloma (MM)
            label id
            d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
            start
            125
          source span
          end
          290
          end exclusive
          true
          exact text
          HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (‎ 1 )
          label id
          d3488fd8-88b2-4f73-9fa4-fbcf14ddd972
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          829581c4c027898d1a0aa82191d39459080fba2b9686d1dd6592efdedb8b3d5d
          start
          148
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22d3488fd8-88b2-4f73-9fa4-fbcf14ddd972%22
          spl effective date
          2026-01-09
          spl set id
          6b9cf32c-6d60-4853-bbfd-2304ffc2c129
          spl version
          4
          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate

          Preserved source evidence · Not medical advice