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LABELS · 2d08d179-39bb-5cd0-e063-6394a90a8ab0

Detectnet

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
2025-01-31
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 Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. Detectnet is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. ( 1 )
Full extracted label fields
application numbers
  1. NDA213227
boxed warning exact
    brand names
    1. Detectnet
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f898c8a7-beb7-4318-a8ea-6f058d69342b
    generic names
    1. COPPER CU 64 DOTATATE
    id
    2d08d179-39bb-5cd0-e063-6394a90a8ab0
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. Detectnet is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. CURIUM US LLC
      matched search terms
      1. tumors
      package ndcs
      1. 69945-064-01
      product ndcs
      1. 69945-064
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00100.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
          100
          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=100&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%222d08d179-39bb-5cd0-e063-6394a90a8ab0%22
          spl effective date
          2025-01-31
          spl effective time
          20250131
          spl set id
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          spl version
          5
          substance names
          1. COPPER OXODOTREOTIDE CU-64
          uniis
          1. N3858377KC
          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
            NDA213227
            payload
            all indexed label documents
            1. Appl No
              213227
              Application Docs Date
              2020-09-22 00:00:00
              Application Docs ID
              64636
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            2. Appl No
              213227
              Application Docs Date
              2021-12-27 00:00:00
              Application Docs ID
              69779
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              213227
              Review Priority
              PRIORITY
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2020-09-03 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              213227
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2021-12-22 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA213227
            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
            2021-12-22
            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
              213227
              Application Docs Date
              2021-12-27 00:00:00
              Application Docs ID
              69779
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              SUPPL
            official application record
            Appl No
            213227
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            CURIUM
            openfda application present
            true
            products
            1. Active Ingredient
              COPPER CU-64 DOTATATE
              Appl No
              213227
              Drug Name
              DETECTNET
              Form
              SOLUTION;INTRAVENOUS
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              4mL (1mCi/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. NDA213227
          brand names
          1. Detectnet
          classification reasons
          1. explicit_positive_indication_predicate
          2. diagnostic_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          393
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. Detectnet is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients
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          source text sha256
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          0
          current approval status
          not_reconciled
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          extraction review status
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          generic names
          1. COPPER CU 64 DOTATATE
          id
          ind-span-71b721f744dd687d8cf7
          label id
          2d08d179-39bb-5cd0-e063-6394a90a8ab0
          positive predicate support span
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          true
          exact text
          is indicated
          label id
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          source field
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          source text sha256
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          start
          34
          qualifier mentions
          1. context exact
            atostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
            kind
            age
            polarity
            not_inferred
            span
            end
            192
            end exclusive
            true
            exact text
            adult patients
            label id
            2d08d179-39bb-5cd0-e063-6394a90a8ab0
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            source text sha256
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            start
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          regulatory links
            schema version
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            source defined aliases
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              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
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              source text sha256
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              start
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%222d08d179-39bb-5cd0-e063-6394a90a8ab0%22
              spl effective date
              2025-01-31
              spl set id
              f898c8a7-beb7-4318-a8ea-6f058d69342b
              spl version
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              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
              diagnostic_candidate
              Passage 2 · positive indication candidate
              application numbers
              1. NDA213227
              brand names
              1. Detectnet
              classification reasons
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              2. diagnostic_use_words
              clinical review status
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              content role
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              context span
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              400
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              true
              exact text
              1 INDICATIONS AND USAGE Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. Detectnet is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. ( 1 )
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              source field
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              source text sha256
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              current approval status
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              generic names
              1. COPPER CU 64 DOTATATE
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              label id
              2d08d179-39bb-5cd0-e063-6394a90a8ab0
              positive predicate support span
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              247
              end exclusive
              true
              exact text
              is a radioactive diagnostic agent indicated
              label id
              2d08d179-39bb-5cd0-e063-6394a90a8ab0
              offset unit
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              source array index
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              source field
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              source text sha256
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              start
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              qualifier mentions
              1. context exact
                atostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
                kind
                age
                polarity
                not_inferred
                span
                end
                393
                end exclusive
                true
                exact text
                adult patients
                label id
                2d08d179-39bb-5cd0-e063-6394a90a8ab0
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                source field
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                source text sha256
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              regulatory links
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                source defined aliases
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                  true
                  exact text
                  Detectnet is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
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                  source url
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                  spl effective date
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                  structured fields status
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                  structured indication
                  age
                  Source null
                  approval pathway
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                  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
                  diagnostic_candidate
                  Passage 3 · unclassified context
                  application numbers
                  1. NDA213227
                  brand names
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                  classification reasons
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                  clinical review status
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                  400
                  end exclusive
                  true
                  exact text
                  etectnet is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. ( 1 )
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                  label id
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                  positive predicate support span
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                        source url
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                        spl effective date
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                        spl set id
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                        structured fields status
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                        structured indication
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                        approval pathway
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                        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
                        unclear

                        Preserved source evidence · Not medical advice