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LABELS · 917e915f-4793-48bf-84c3-50272421616f

SUPPRELIN LA

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
2025-09-25
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 SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia. SUPPRELIN LA is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of children with central precocious puberty (CPP) ( 1 ).
Full extracted label fields
application numbers
  1. NDA022058
boxed warning exact
    brand names
    1. SUPPRELIN LA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d8fb000e-3cc9-4803-b71d-2cc597661977
    generic names
    1. HISTRELIN ACETATE
    id
    917e915f-4793-48bf-84c3-50272421616f
    indications and usage exact
    1. 1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia. SUPPRELIN LA is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of children with central precocious puberty (CPP) ( 1 ).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Endo USA, Inc.
      matched search terms
      1. tumor
      2. tumors
      package ndcs
      1. 67979-002-01
      product ndcs
      1. 67979-002
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Severe Cutaneous Adverse Reactions ( 5.5 ) 09/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 1294641
      2. 1740437
      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%22917e915f-4793-48bf-84c3-50272421616f%22
      spl effective date
      2025-09-25
      spl effective time
      20250925
      spl set id
      d8fb000e-3cc9-4803-b71d-2cc597661977
      spl version
      38
      substance names
      1. HISTRELIN ACETATE
      uniis
      1. QMG7HLD1ZE
      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
        NDA022058
        payload
        all indexed label documents
        1. Appl No
          022058
          Application Docs Date
          2011-11-18 00:00:00
          Application Docs ID
          16859
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        2. Appl No
          022058
          Application Docs Date
          2012-04-06 00:00:00
          Application Docs ID
          16860
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        3. Appl No
          022058
          Application Docs Date
          2007-05-07 00:00:00
          Application Docs ID
          38158
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        4. Appl No
          022058
          Application Docs Date
          2008-07-09 00:00:00
          Application Docs ID
          38159
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        5. Appl No
          022058
          Application Docs Date
          2016-07-13 00:00:00
          Application Docs ID
          38160
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        6. Appl No
          022058
          Application Docs Date
          2013-04-09 00:00:00
          Application Docs ID
          38161
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        7. Appl No
          022058
          Application Docs Date
          2017-05-19 00:00:00
          Application Docs ID
          48471
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        8. Appl No
          022058
          Application Docs Date
          2017-05-22 00:00:00
          Application Docs ID
          48472
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        9. Appl No
          022058
          Application Docs Date
          2019-11-12 00:00:00
          Application Docs ID
          60822
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        10. Appl No
          022058
          Application Docs Date
          2022-04-27 00:00:00
          Application Docs ID
          70824
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        11. Appl No
          022058
          Application Docs Date
          2025-09-25 00:00:00
          Application Docs ID
          83461
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          2025-09-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2022-04-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2019-11-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2017-05-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2017-05-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2015-04-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2013-04-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2012-04-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2013-06-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2011-10-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          022058
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2008-07-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          022058
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2007-11-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA022058
        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
        2025-09-23
        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
          022058
          Application Docs Date
          2025-09-25 00:00:00
          Application Docs ID
          83461
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        official application record
        Appl No
        022058
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ENDO OPERATIONS
        openfda application present
        true
        products
        1. Active Ingredient
          HISTRELIN ACETATE
          Appl No
          022058
          Drug Name
          SUPPRELIN LA
          Form
          IMPLANT;SUBCUTANEOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          50MG
          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. NDA022058
      brand names
      1. SUPPRELIN LA
      classification reasons
      1. explicit_positive_indication_predicate
      2. no_tumor_directed_keyword_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      359
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significant
      label id
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      offset unit
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      source text sha256
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      duplicate text group
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      extraction review status
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      generic names
      1. HISTRELIN ACETATE
      id
      ind-span-9a1e2756b079f81ded81
      label id
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      positive predicate support span
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      90
      end exclusive
      true
      exact text
      is indicated
      label id
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      qualifier mentions
      1. context exact
        ate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).
        kind
        age
        polarity
        not_inferred
        span
        end
        120
        end exclusive
        true
        exact text
        children
        label id
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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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          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).
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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
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          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
          non_oncology_or_unclear_candidate
          Passage 2 · unclassified context
          application numbers
          1. NDA022058
          brand names
          1. SUPPRELIN LA
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          530
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement
          label id
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          offset unit
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          1. HISTRELIN ACETATE
          id
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          label id
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          positive predicate support span
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          qualifier mentions
          1. context exact
            Children with CPP (neurogenic or idiopathic) have an early onset of
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            Children
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          2. context exact
            rly onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males).
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            end exclusive
            true
            exact text
            8 years of age
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          3. context exact
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          regulatory links
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              end exclusive
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              exact text
              Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males).
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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
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              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
              Passage 3 · unclassified context
              application numbers
              1. NDA022058
              brand names
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              classification reasons
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              clinical review status
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              end exclusive
              true
              exact text
              al precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormon
              label id
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              offset unit
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              current approval status
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              id
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              label id
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              positive predicate support span
              Source null
              qualifier mentions
              1. context exact
                gnificantly advanced bone age that can result in diminished adult height attainment.
                kind
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                not_inferred
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                415
                end exclusive
                true
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                                  Preserved source evidence · Not medical advice