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LABELS · 4a638cd1-6922-477a-aa17-a70865ae0bd8

Elliotts B

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
2024-10-16
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
Full extracted label fields
application numbers
  1. NDA020577
boxed warning exact
    brand names
    1. Elliotts B
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08036dbd-55b3-47b9-9890-000f253544f3
    generic names
    1. SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE
    id
    4a638cd1-6922-477a-aa17-a70865ae0bd8
    indications and usage exact
    1. INDICATIONS AND USAGE Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Lukare Medical, LLC
      matched search terms
      1. lymphoma
      2. leukemia
      package ndcs
      1. 55792-007-01
      2. 55792-007-10
      product ndcs
      1. 55792-007
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRATHECAL
        rxcuis
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00200.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
          200
          total
          830
          sha256
          d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
          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=200&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%224a638cd1-6922-477a-aa17-a70865ae0bd8%22
          spl effective date
          2024-10-16
          spl effective time
          20241016
          spl set id
          08036dbd-55b3-47b9-9890-000f253544f3
          spl version
          6
          substance names
          1. SODIUM CHLORIDE
          2. SODIUM BICARBONATE
          3. ANHYDROUS DEXTROSE
          4. MAGNESIUM SULFATE, UNSPECIFIED FORM
          5. POTASSIUM CHLORIDE
          6. CALCIUM CHLORIDE
          7. SODIUM PHOSPHATE
          uniis
          1. 451W47IQ8X
          2. 8MDF5V39QO
          3. 5SL0G7R0OK
          4. DE08037SAB
          5. 660YQ98I10
          6. M4I0D6VV5M
          7. SE337SVY37
          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
            NDA020577
            payload
            all indexed label documents
              all submission records
              1. Appl No
                020577
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                10
                Submission Status
                AP
                Submission Status Date
                2016-11-29 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                9
                Submission Status
                AP
                Submission Status Date
                2015-12-17 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                8
                Submission Status
                AP
                Submission Status Date
                2014-07-18 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                7
                Submission Status
                AP
                Submission Status Date
                2012-12-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                6
                Submission Status
                AP
                Submission Status Date
                2015-06-11 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                4
                Submission Status
                AP
                Submission Status Date
                2000-11-17 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                3
                Submission Status
                AP
                Submission Status Date
                1998-05-22 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                2
                Submission Status
                AP
                Submission Status Date
                1998-05-22 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                1
                Submission Status
                AP
                Submission Status Date
                1997-12-02 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                020577
                Review Priority
                PRIORITY
                Submission Class Code ID
                12
                Submission No
                1
                Submission Status
                AP
                Submission Status Date
                1996-09-27 00:00:00
                Submission Type
                ORIG
                Submissions Public Notes
              application number
              NDA020577
              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
              2016-11-29
              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
                official application record
                Appl No
                020577
                Appl Public Notes
                Appl Type
                NDA
                Sponsor Name
                LUKARE MEDICAL LLC
                openfda application present
                true
                products
                1. Active Ingredient
                  CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
                  Appl No
                  020577
                  Drug Name
                  ELLIOTTS B SOLUTION
                  Form
                  INJECTABLE;INTRATHECAL
                  Product No
                  001
                  Reference Drug
                  1
                  Reference Standard
                  1
                  Strength
                  0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML
                  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. NDA020577
              brand names
              1. Elliotts B
              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
              219
              end exclusive
              true
              exact text
              INDICATIONS AND USAGE Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
              label id
              4a638cd1-6922-477a-aa17-a70865ae0bd8
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              f1850591b646bb0eba9e9cd8e9a3529955eb72e8a32f28063c26a88e408ab8d1
              start
              0
              current approval status
              not_reconciled
              duplicate text group
              dup-c01601b541cd61578cb0
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE
              id
              ind-span-476c8860ec15bd615ab4
              label id
              4a638cd1-6922-477a-aa17-a70865ae0bd8
              positive predicate support span
              end
              54
              end exclusive
              true
              exact text
              is indicated
              label id
              4a638cd1-6922-477a-aa17-a70865ae0bd8
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              f1850591b646bb0eba9e9cd8e9a3529955eb72e8a32f28063c26a88e408ab8d1
              start
              42
              qualifier mentions
              1. context exact
                ndicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic
                kind
                biomarker
                polarity
                not_inferred
                span
                end
                149
                end exclusive
                true
                exact text
                methotrexate sodium and cytarabine for the
                label id
                4a638cd1-6922-477a-aa17-a70865ae0bd8
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                f1850591b646bb0eba9e9cd8e9a3529955eb72e8a32f28063c26a88e408ab8d1
                start
                106
              regulatory links
                schema version
                0.1.0
                source batch sha256
                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                source defined aliases
                  source span
                  end
                  219
                  end exclusive
                  true
                  exact text
                  INDICATIONS AND USAGE Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
                  label id
                  4a638cd1-6922-477a-aa17-a70865ae0bd8
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  f1850591b646bb0eba9e9cd8e9a3529955eb72e8a32f28063c26a88e408ab8d1
                  start
                  0
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%224a638cd1-6922-477a-aa17-a70865ae0bd8%22
                  spl effective date
                  2024-10-16
                  spl set id
                  08036dbd-55b3-47b9-9890-000f253544f3
                  spl version
                  6
                  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