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LABELS · d4332d30-8a83-4118-88bb-3c49851837b6

LUTRATE DEPOT

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
2025-06-03
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
Full extracted label fields
application numbers
  1. NDA205054
boxed warning exact
    brand names
    1. LUTRATE DEPOT
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a6d1373-17d9-4289-b62f-d299ffe55831
    generic names
    1. LEUPROLIDE ACETATE
    id
    d4332d30-8a83-4118-88bb-3c49851837b6
    indications and usage exact
    1. 1 INDICATIONS AND USAGE LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Avyxa Pharma, LLC
      matched search terms
      1. cancer
      package ndcs
      1. 83831-134-01
      2. 83831-150-22
      3. 83831-135-02
      product ndcs
      1. 83831-134
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.6 ) 11/2024
      record type
      complete_spl_indications_section_candidate
      routes
        rxcuis
        1. 2606516
        2. 2709448
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00600.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
        600
        total
        830
        sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        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=600&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22d4332d30-8a83-4118-88bb-3c49851837b6%22
        spl effective date
        2025-06-03
        spl effective time
        20250603
        spl set id
        3a6d1373-17d9-4289-b62f-d299ffe55831
        spl version
        2
        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
              NDA205054
              payload
              all indexed label documents
              1. Appl No
                205054
                Application Docs Date
                2018-10-22 00:00:00
                Application Docs ID
                56051
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              2. Appl No
                205054
                Application Docs Date
                2023-03-01 00:00:00
                Application Docs ID
                73650
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                4
                Submission Type
                SUPPL
              3. Appl No
                205054
                Application Docs Date
                2023-12-01 00:00:00
                Application Docs ID
                76709
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5
                Submission Type
                SUPPL
              4. Appl No
                205054
                Application Docs Date
                2024-08-12 00:00:00
                Application Docs ID
                79363
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                6
                Submission Type
                SUPPL
              5. Appl No
                205054
                Application Docs Date
                2024-11-15 00:00:00
                Application Docs ID
                80220
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                7
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                205054
                Review Priority
                STANDARD
                Submission Class Code ID
                15
                Submission No
                1
                Submission Status
                AP
                Submission Status Date
                2018-08-28 00:00:00
                Submission Type
                ORIG
                Submissions Public Notes
              2. Appl No
                205054
                Review Priority
                STANDARD
                Submission Class Code ID
                2
                Submission No
                4
                Submission Status
                AP
                Submission Status Date
                2023-02-28 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                205054
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                5
                Submission Status
                AP
                Submission Status Date
                2023-11-30 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                205054
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                6
                Submission Status
                AP
                Submission Status Date
                2024-08-08 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                205054
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                7
                Submission Status
                AP
                Submission Status Date
                2024-11-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA205054
              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
              2024-11-14
              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
                205054
                Application Docs Date
                2024-11-15 00:00:00
                Application Docs ID
                80220
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                7
                Submission Type
                SUPPL
              official application record
              Appl No
              205054
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              INVAGEN PHARMS
              openfda application present
              true
              products
              1. Active Ingredient
                LEUPROLIDE ACETATE
                Appl No
                205054
                Drug Name
                LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
                Form
                FOR SUSPENSION;INTRAMUSCULAR
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                22.5MG/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
            1. NDA205054
            brand names
            1. LUTRATE DEPOT
            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
            274
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
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            source text sha256
            ceae03cc416aeef6f0e659a80308460e37e6adbd27208bc44e5b0f59952c17a8
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            current approval status
            not_reconciled
            duplicate text group
            dup-0f15e4ab7c403e69f4a2
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. LEUPROLIDE ACETATE
            id
            ind-span-22511714d16f344362c3
            label id
            d4332d30-8a83-4118-88bb-3c49851837b6
            positive predicate support span
            end
            106
            end exclusive
            true
            exact text
            is indicated
            label id
            d4332d30-8a83-4118-88bb-3c49851837b6
            offset unit
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            source field
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            source text sha256
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            start
            94
            qualifier mentions
            1. context exact
              stration (leuprolide acetate) is indicated for treatment of advanced prostate cancer.
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              148
              end exclusive
              true
              exact text
              advanced prostate cancer
              label id
              d4332d30-8a83-4118-88bb-3c49851837b6
              offset unit
              unicode_code_points
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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 defined aliases
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                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer.
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                d4332d30-8a83-4118-88bb-3c49851837b6
                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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                start
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                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22d4332d30-8a83-4118-88bb-3c49851837b6%22
                spl effective date
                2025-06-03
                spl set id
                3a6d1373-17d9-4289-b62f-d299ffe55831
                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
                tumor_directed_candidate
                Passage 2 · positive indication candidate
                application numbers
                1. NDA205054
                brand names
                1. LUTRATE DEPOT
                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
                274
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
                label id
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                offset unit
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                source array index
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                source text sha256
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                1. LEUPROLIDE ACETATE
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                label id
                d4332d30-8a83-4118-88bb-3c49851837b6
                positive predicate support span
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                end exclusive
                true
                exact text
                is a gonadotropin-releasing hormone (GnRH) agonist indicated
                label id
                d4332d30-8a83-4118-88bb-3c49851837b6
                offset unit
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                qualifier mentions
                1. context exact
                  eleasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer.
                  kind
                  stage_or_setting
                  polarity
                  not_inferred
                  span
                  end
                  267
                  end exclusive
                  true
                  exact text
                  advanced prostate cancer
                  label id
                  d4332d30-8a83-4118-88bb-3c49851837b6
                  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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                regulatory links
                  schema version
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                  source defined aliases
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                    end exclusive
                    true
                    exact text
                    LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer.
                    label id
                    d4332d30-8a83-4118-88bb-3c49851837b6
                    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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                    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
                    tumor_directed_candidate
                    Passage 3 · unclassified context
                    application numbers
                    1. NDA205054
                    brand names
                    1. LUTRATE DEPOT
                    classification reasons
                    1. no_unambiguous_positive_indication_predicate
                    clinical review status
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                    content role
                    unclassified_context
                    context span
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                    274
                    end exclusive
                    true
                    exact text
                    ion (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
                    label id
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                    current approval status
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                    extraction review status
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                    generic names
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                    id
                    ind-span-a4cbcd2b6ac322dd049f
                    label id
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                    positive predicate support span
                    Source null
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                      regulatory links
                        schema version
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                        source batch sha256
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                          end exclusive
                          true
                          exact text
                          ( 1 )
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                          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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                          start
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                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%22d4332d30-8a83-4118-88bb-3c49851837b6%22
                          spl effective date
                          2025-06-03
                          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