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LABELS · 9e573457-066c-46b8-9a26-b99ec4e796e6

NETSPOT

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
2026-07-06
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )
Full extracted label fields
application numbers
  1. NDA208547
boxed warning exact
    brand names
    1. NETSPOT
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b2b3be70-17d8-4093-896c-f1c54a2cf242
    generic names
    1. 68GA-DOTATATE
    id
    9e573457-066c-46b8-9a26-b99ec4e796e6
    indications and usage exact
    1. 1 INDICATIONS AND USAGE NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Advanced Accelerator Applications USA, Inc
      matched search terms
      1. tumors
      package ndcs
      1. 69488-001-40
      product ndcs
      1. 69488-001
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.3 ) 10/2023
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00500.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
        500
        total
        830
        sha256
        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
        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=500&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%229e573457-066c-46b8-9a26-b99ec4e796e6%22
        spl effective date
        2026-07-06
        spl effective time
        20260706
        spl set id
        b2b3be70-17d8-4093-896c-f1c54a2cf242
        spl version
        23
        substance names
          uniis
            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
              NDA208547
              payload
              all indexed label documents
              1. Appl No
                208547
                Application Docs Date
                2016-06-02 00:00:00
                Application Docs ID
                19996
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              2. Appl No
                208547
                Application Docs Date
                2016-09-02 00:00:00
                Application Docs ID
                45202
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                2
                Submission Type
                SUPPL
              3. Appl No
                208547
                Application Docs Date
                2017-01-24 00:00:00
                Application Docs ID
                46951
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                4
                Submission Type
                SUPPL
              4. Appl No
                208547
                Application Docs Date
                2018-04-13 00:00:00
                Application Docs ID
                53666
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                11
                Submission Type
                SUPPL
              5. Appl No
                208547
                Application Docs Date
                2021-06-28 00:00:00
                Application Docs ID
                67909
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                22
                Submission Type
                SUPPL
              6. Appl No
                208547
                Application Docs Date
                2021-06-28 00:00:00
                Application Docs ID
                67910
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                20
                Submission Type
                SUPPL
              7. Appl No
                208547
                Application Docs Date
                2021-12-27 00:00:00
                Application Docs ID
                69781
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                24
                Submission Type
                SUPPL
              8. Appl No
                208547
                Application Docs Date
                2023-10-27 00:00:00
                Application Docs ID
                75975
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                27
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                208547
                Review Priority
                PRIORITY
                Submission Class Code ID
                7
                Submission No
                1
                Submission Status
                AP
                Submission Status Date
                2016-06-01 00:00:00
                Submission Type
                ORIG
                Submissions Public Notes
              2. Appl No
                208547
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                2
                Submission Status
                AP
                Submission Status Date
                2016-09-02 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                208547
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                3
                Submission Status
                AP
                Submission Status Date
                2016-10-31 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                208547
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                4
                Submission Status
                AP
                Submission Status Date
                2017-01-20 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                208547
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                11
                Submission Status
                AP
                Submission Status Date
                2018-04-12 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                208547
                Review Priority
                N/A
                Submission Class Code ID
                4
                Submission No
                12
                Submission Status
                AP
                Submission Status Date
                2018-09-27 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                208547
                Review Priority
                N/A
                Submission Class Code ID
                4
                Submission No
                13
                Submission Status
                AP
                Submission Status Date
                2018-08-09 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                208547
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                20
                Submission Status
                AP
                Submission Status Date
                2021-06-22 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                208547
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                22
                Submission Status
                AP
                Submission Status Date
                2021-06-22 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                208547
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                24
                Submission Status
                AP
                Submission Status Date
                2021-12-22 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                208547
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                27
                Submission Status
                AP
                Submission Status Date
                2023-10-26 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA208547
              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
              2023-10-26
              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
                208547
                Application Docs Date
                2023-10-27 00:00:00
                Application Docs ID
                75975
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                27
                Submission Type
                SUPPL
              official application record
              Appl No
              208547
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              NOVARTIS
              openfda application present
              true
              products
              1. Active Ingredient
                GALLIUM DOTATATE GA-68
                Appl No
                208547
                Drug Name
                NETSPOT
                Form
                POWDER;INTRAVENOUS
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                2.1-5.5mCi/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. NDA208547
            brand names
            1. NETSPOT
            classification reasons
            1. explicit_positive_indication_predicate
            2. diagnostic_use_words
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            443
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendoc
            label id
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            current approval status
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            duplicate text group
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            extraction review status
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            generic names
            1. 68GA-DOTATATE
            id
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            label id
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            positive predicate support span
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            end exclusive
            true
            exact text
            is indicated
            label id
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            qualifier mentions
            1. context exact
              atostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
              kind
              age
              polarity
              not_inferred
              span
              end
              219
              end exclusive
              true
              exact text
              adult
              label id
              9e573457-066c-46b8-9a26-b99ec4e796e6
              offset unit
              unicode_code_points
              source array index
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              source field
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              source text sha256
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            2. context exact
              receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
              kind
              age
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              not_inferred
              span
              end
              242
              end exclusive
              true
              exact text
              pediatric patients
              label id
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              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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            regulatory links
              schema version
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              source batch sha256
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              source defined aliases
                source span
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                true
                exact text
                1 INDICATIONS AND USAGE NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
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                source text sha256
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                source url
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                spl effective date
                2026-07-06
                spl set id
                b2b3be70-17d8-4093-896c-f1c54a2cf242
                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. NDA208547
                brand names
                1. NETSPOT
                classification reasons
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                clinical review status
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                500
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                true
                exact text
                labeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )
                label id
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                generic names
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                exact text
                is a radioactive diagnostic agent indicated
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                qualifier mentions
                1. context exact
                  atostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
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                2. context exact
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                    exact text
                    NETSPOT, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
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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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                    Source null
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                    Source null
                    disease stage
                    Source null
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                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
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                    tumor histology
                    Source null
                    use intent
                    diagnostic_candidate
                    Passage 3 · unclassified context
                    application numbers
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                    brand names
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                    exact text
                    radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )
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                          source url
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                          spl effective date
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                          spl set id
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                          spl version
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                          structured fields status
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                          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
                          unclear

                          Preserved source evidence · Not medical advice