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LABELS · d7c452f3-aedd-4c8b-9e8e-46690c56a29c

Lupron 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
2026-03-15
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer. LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer. ( 1 )
Full extracted label fields
application numbers
  1. NDA020517
  2. NDA019732
boxed warning exact
    brand names
    1. Lupron Depot
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbc8f94e-7330-4465-05ad-16d64493a5dd
    generic names
    1. LEUPROLIDE ACETATE
    id
    d7c452f3-aedd-4c8b-9e8e-46690c56a29c
    indications and usage exact
    1. 1 INDICATIONS AND USAGE LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer. LUPRON 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. AbbVie Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 0074-3473-03
      2. 0074-3473-55
      3. 0074-9945-01
      4. 0074-0009-01
      5. 0074-3683-03
      6. 0074-3683-55
      7. 0074-9930-01
      8. 0074-3642-03
      9. 0074-3642-55
      10. 0074-9907-01
      11. 0074-3346-03
      12. 0074-3346-55
      product ndcs
      1. 0074-3346
      2. 0074-3473
      3. 0074-3683
      4. 0074-3642
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2 ) 8/2025 Dosage Forms and Strengths ( 3 ) 8/2025
      record type
      complete_spl_indications_section_candidate
      routes
        rxcuis
        1. 1115257
        2. 1115259
        3. 1115462
        4. 1115464
        5. 1115467
        6. 1115468
        7. 1946521
        8. 1946522
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00700.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
        700
        total
        830
        sha256
        24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
        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=700&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22d7c452f3-aedd-4c8b-9e8e-46690c56a29c%22
        spl effective date
        2026-03-15
        spl effective time
        20260315
        spl set id
        cbc8f94e-7330-4465-05ad-16d64493a5dd
        spl version
        1543
        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
              NDA019732
              payload
              all indexed label documents
              1. Appl No
                019732
                Application Docs Date
                2003-05-30 00:00:00
                Application Docs ID
                11658
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                12
                Submission Type
                SUPPL
              2. Appl No
                019732
                Application Docs Date
                2010-05-07 00:00:00
                Application Docs ID
                11659
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                31
                Submission Type
                SUPPL
              3. Appl No
                019732
                Application Docs Date
                2010-05-07 00:00:00
                Application Docs ID
                11660
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                36
                Submission Type
                SUPPL
              4. Appl No
                019732
                Application Docs Date
                2011-01-20 00:00:00
                Application Docs ID
                11661
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                37
                Submission Type
                SUPPL
              5. Appl No
                019732
                Application Docs Date
                2012-02-22 00:00:00
                Application Docs ID
                11662
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                38
                Submission Type
                SUPPL
              6. Appl No
                019732
                Application Docs Date
                2014-07-01 00:00:00
                Application Docs ID
                11663
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                41
                Submission Type
                SUPPL
              7. Appl No
                019732
                Application Docs Date
                2016-06-13 00:00:00
                Application Docs ID
                11664
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                42
                Submission Type
                SUPPL
              8. Appl No
                019732
                Application Docs Date
                2010-05-07 00:00:00
                Application Docs ID
                33892
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                35
                Submission Type
                SUPPL
              9. Appl No
                019732
                Application Docs Date
                2013-07-11 00:00:00
                Application Docs ID
                33893
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                40
                Submission Type
                SUPPL
              10. Appl No
                019732
                Application Docs Date
                2019-01-09 00:00:00
                Application Docs ID
                57142
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                43
                Submission Type
                SUPPL
              11. Appl No
                019732
                Application Docs Date
                2019-03-05 00:00:00
                Application Docs ID
                57891
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                44
                Submission Type
                SUPPL
              12. Appl No
                019732
                Application Docs Date
                2022-04-20 00:00:00
                Application Docs ID
                70793
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                45
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                50
                Submission Status
                AP
                Submission Status Date
                2025-08-18 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                49
                Submission Status
                AP
                Submission Status Date
                2024-03-21 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                48
                Submission Status
                AP
                Submission Status Date
                2023-12-04 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                2
                Submission No
                45
                Submission Status
                AP
                Submission Status Date
                2022-04-18 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                44
                Submission Status
                AP
                Submission Status Date
                2019-03-04 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                43
                Submission Status
                AP
                Submission Status Date
                2018-12-10 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                42
                Submission Status
                AP
                Submission Status Date
                2016-06-06 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                41
                Submission Status
                AP
                Submission Status Date
                2014-06-27 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                40
                Submission Status
                AP
                Submission Status Date
                2013-07-10 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                019732
                Review Priority
                UNKNOWN
                Submission Class Code ID
                3
                Submission No
                38
                Submission Status
                AP
                Submission Status Date
                2012-02-17 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                019732
                Review Priority
                901 REQUIRED
                Submission Class Code ID
                3
                Submission No
                37
                Submission Status
                AP
                Submission Status Date
                2011-01-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              12. Appl No
                019732
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                36
                Submission Status
                AP
                Submission Status Date
                2010-04-28 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA019732
              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
              2025-08-18
              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
                019732
                Application Docs Date
                2025-08-20 00:00:00
                Application Docs ID
                83146
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                50
                Submission Type
                SUPPL
              official application record
              Appl No
              019732
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              ABBVIE ENDOCRINE INC
              openfda application present
              true
              products
              1. Active Ingredient
                LEUPROLIDE ACETATE
                Appl No
                019732
                Drug Name
                LUPRON DEPOT
                Form
                INJECTABLE;INJECTION
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                7.5MG
                marketing status
                1. Prescription
            2. application number
              NDA020517
              payload
              all indexed label documents
              1. Appl No
                020517
                Application Docs Date
                2010-05-07 00:00:00
                Application Docs ID
                12665
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                24
                Submission Type
                SUPPL
              2. Appl No
                020517
                Application Docs Date
                2010-05-07 00:00:00
                Application Docs ID
                12666
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                29
                Submission Type
                SUPPL
              3. Appl No
                020517
                Application Docs Date
                2011-01-20 00:00:00
                Application Docs ID
                12667
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                31
                Submission Type
                SUPPL
              4. Appl No
                020517
                Application Docs Date
                2011-06-28 00:00:00
                Application Docs ID
                12668
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                32
                Submission Type
                SUPPL
              5. Appl No
                020517
                Application Docs Date
                2012-07-19 00:00:00
                Application Docs ID
                12669
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                33
                Submission Type
                SUPPL
              6. Appl No
                020517
                Application Docs Date
                2013-07-11 00:00:00
                Application Docs ID
                12670
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                35
                Submission Type
                SUPPL
              7. Appl No
                020517
                Application Docs Date
                2016-06-13 00:00:00
                Application Docs ID
                12671
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                38
                Submission Type
                SUPPL
              8. Appl No
                020517
                Application Docs Date
                2011-06-28 00:00:00
                Application Docs ID
                34744
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                25
                Submission Type
                SUPPL
              9. Appl No
                020517
                Application Docs Date
                2010-05-07 00:00:00
                Application Docs ID
                34745
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                28
                Submission Type
                SUPPL
              10. Appl No
                020517
                Application Docs Date
                2011-06-28 00:00:00
                Application Docs ID
                34746
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                30
                Submission Type
                SUPPL
              11. Appl No
                020517
                Application Docs Date
                2014-07-01 00:00:00
                Application Docs ID
                34747
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                36
                Submission Type
                SUPPL
              12. Appl No
                020517
                Application Docs Date
                2019-01-09 00:00:00
                Application Docs ID
                57143
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                41
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                47
                Submission Status
                AP
                Submission Status Date
                2025-08-18 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                46
                Submission Status
                AP
                Submission Status Date
                2024-03-21 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                45
                Submission Status
                AP
                Submission Status Date
                2023-12-04 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                2
                Submission No
                43
                Submission Status
                AP
                Submission Status Date
                2022-04-18 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                42
                Submission Status
                AP
                Submission Status Date
                2019-03-04 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                41
                Submission Status
                AP
                Submission Status Date
                2018-12-10 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                38
                Submission Status
                AP
                Submission Status Date
                2016-06-06 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                37
                Submission Status
                AP
                Submission Status Date
                2016-02-11 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                36
                Submission Status
                AP
                Submission Status Date
                2014-06-27 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                35
                Submission Status
                AP
                Submission Status Date
                2013-07-10 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                34
                Submission Status
                AP
                Submission Status Date
                2013-11-08 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              12. Appl No
                020517
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                33
                Submission Status
                AP
                Submission Status Date
                2012-07-18 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA020517
              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
              2025-08-18
              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
                020517
                Application Docs Date
                2025-08-20 00:00:00
                Application Docs ID
                83147
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                47
                Submission Type
                SUPPL
              official application record
              Appl No
              020517
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              ABBVIE ENDOCRINE INC
              openfda application present
              true
              products
              1. Active Ingredient
                LEUPROLIDE ACETATE
                Appl No
                020517
                Drug Name
                LUPRON DEPOT
                Form
                INJECTABLE;INJECTION
                Product No
                001
                Reference Drug
                1
                Reference Standard
                0
                Strength
                22.5MG
                marketing status
                1. Prescription
              2. Active Ingredient
                LEUPROLIDE ACETATE
                Appl No
                020517
                Drug Name
                LUPRON DEPOT
                Form
                INJECTABLE;INJECTION
                Product No
                002
                Reference Drug
                1
                Reference Standard
                1
                Strength
                30MG
                marketing status
                1. Prescription
              3. Active Ingredient
                LEUPROLIDE ACETATE
                Appl No
                020517
                Drug Name
                LUPRON DEPOT
                Form
                INJECTABLE;INJECTION
                Product No
                003
                Reference Drug
                1
                Reference Standard
                1
                Strength
                45MG
                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. NDA020517
            2. NDA019732
            brand names
            1. Lupron 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
            384
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer. LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer. ( 1 )
            label id
            d7c452f3-aedd-4c8b-9e8e-46690c56a29c
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            4f7fa49114625d44edab84e7830f4f43c38266b31c1f5099f11af5a6a3933d0d
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-df21d68c3b42b1ef3912
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. LEUPROLIDE ACETATE
            id
            ind-span-33dc35c14e2a9b39d338
            label id
            d7c452f3-aedd-4c8b-9e8e-46690c56a29c
            positive predicate support span
            end
            213
            end exclusive
            true
            exact text
            are indicated
            label id
            d7c452f3-aedd-4c8b-9e8e-46690c56a29c
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            4f7fa49114625d44edab84e7830f4f43c38266b31c1f5099f11af5a6a3933d0d
            start
            200
            qualifier mentions
            1. context exact
              ion (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.
              kind
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                1 INDICATIONS AND USAGE LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.
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                          Preserved source evidence · Not medical advice