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LABELS · 2489f99a-e34f-4773-be47-35ebb68cabfb

RYANODEX dantrolene sodium

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
2024-10-30
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 RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk. ( 1 )
Full extracted label fields
application numbers
  1. NDA205579
boxed warning exact
    brand names
    1. RYANODEX dantrolene sodium
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f7b3ac0-604d-4c78-b545-5e0f8ea3d698
    generic names
    1. DANTROLENE SODIUM
    id
    2489f99a-e34f-4773-be47-35ebb68cabfb
    indications and usage exact
    1. 1 INDICATIONS AND USAGE RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Eagle Pharmaceuticals, Inc.
      matched search terms
      1. malignant
      package ndcs
      1. 42367-540-32
      product ndcs
      1. 42367-540
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1544753
        2. 1544758
        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
        2024-10-30
        spl effective time
        20241030
        spl set id
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        spl version
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        substance names
        1. DANTROLENE SODIUM
        uniis
        1. 287M0347EV
        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
          NDA205579
          payload
          all indexed label documents
          1. Appl No
            205579
            Application Docs Date
            2014-07-24 00:00:00
            Application Docs ID
            40483
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            205579
            Application Docs Date
            2020-09-01 00:00:00
            Application Docs ID
            64465
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          3. Appl No
            205579
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78048
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            205579
            Review Priority
            PRIORITY
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2014-07-22 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            205579
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2015-10-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            205579
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2020-08-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            205579
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2024-04-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA205579
          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
          2024-04-02
          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
            205579
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78048
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          official application record
          Appl No
          205579
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          EAGLE PHARMS
          openfda application present
          true
          products
          1. Active Ingredient
            DANTROLENE SODIUM
            Appl No
            205579
            Drug Name
            RYANODEX
            Form
            FOR SUSPENSION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            250MG/VIAL
            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
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        brand names
        1. RYANODEX dantrolene sodium
        classification reasons
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        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
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        447
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patie
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              1 INDICATIONS AND USAGE RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk.
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              for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk. ( 1 )
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              is a skeletal muscle relaxant drug indicated
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                    RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures.
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                    source url
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                    Passage 3 · unclassified context
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                    exact text
                    of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk. ( 1 )
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                          ( 1 ) Prevention of malignant hyperthermia in patients at high risk.
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                          letal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk. ( 1 )
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                                ( 1 )
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                                Preserved source evidence · Not medical advice