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LABELS · 2784e7a8-d4f1-fa61-e063-6394a90a614e

Gallium Ga-68 PSMA-11

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
2025-01-01
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 Gallium Ga 68 Gozetotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. (1 )
Full extracted label fields
application numbers
  1. NDA212642
boxed warning exact
    brand names
    1. Gallium Ga-68 PSMA-11
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7744bafb-755e-29a2-e053-2991aa0a86a9
    generic names
    1. GALLIUM GA-68 GOZETOTIDE
    id
    2784e7a8-d4f1-fa61-e063-6394a90a614e
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Gallium Ga 68 Gozetotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. (1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. UCLA Biomedical Cyclotron
      matched search terms
      1. cancer
      package ndcs
      1. 76394-2642-3
      product ndcs
      1. 76394-2642
      product types
      1. HUMAN PRESCRIPTION DRUG
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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
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          sha256
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          url
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          source url
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          spl effective date
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          spl effective time
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          1. GALLIUM GA-68 GOZETOTIDE
          uniis
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          Drugs@FDA application source records
          1. application number
            NDA212642
            payload
            all indexed label documents
            1. Appl No
              212642
              Application Docs Date
              2020-12-02 00:00:00
              Application Docs ID
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              Application Docs Title
              0
              Application Docs Type ID
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              Submission No
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            2. Appl No
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              Application Docs Date
              2021-11-18 00:00:00
              Application Docs ID
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              Application Docs Title
              0
              Application Docs Type ID
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              Submission No
              1
              Submission Type
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            3. Appl No
              212642
              Application Docs Date
              2022-06-21 00:00:00
              Application Docs ID
              71355
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              2
              Submission Type
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            all submission records
            1. Appl No
              212642
              Review Priority
              STANDARD
              Submission Class Code ID
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              Submission No
              1
              Submission Status
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              Submission Status Date
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              Submission Type
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              Submissions Public Notes
            2. Appl No
              212642
              Review Priority
              STANDARD
              Submission Class Code ID
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              Submission No
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              Submission Status
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              Submission Status Date
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              Submission Type
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              Submissions Public Notes
            3. Appl No
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              Review Priority
              STANDARD
              Submission Class Code ID
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              Submission No
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              Submission Status
              AP
              Submission Status Date
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              Submission Type
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              Submissions Public Notes
            application number
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            approval interpretation
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            current indication status
            not_reconciled
            has approved submission record
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            latest approved submission date
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            latest posted label documents
            1. Appl No
              212642
              Application Docs Date
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              Application Docs ID
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              Application Docs Title
              0
              Application Docs Type ID
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              Submission No
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              Submission Type
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            official application record
            Appl No
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            Appl Public Notes
            Appl Type
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            Sponsor Name
            UNIV CA LOS ANGELES
            openfda application present
            true
            products
            1. Active Ingredient
              GALLIUM GA-68 GOZETOTIDE
              Appl No
              212642
              Drug Name
              GALLIUM GA 68 GOZETOTIDE
              Form
              SOLUTION;INTRAVENOUS
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              0.5-5mCi/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
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          brand names
          1. Gallium Ga-68 PSMA-11
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          2. diagnostic_use_words
          clinical review status
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          567
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          true
          exact text
          1 INDICATIONS AND USAGE Gallium Ga 68 Gozetotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostat
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              1 INDICATIONS AND USAGE Gallium Ga 68 Gozetotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
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              ions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. (1 )
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                  Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
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                        Preserved source evidence · Not medical advice