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LABELS · ac43d5b2-3223-b955-2798-555d48497798

Trelstar

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
2026-06-30
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 TRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )
Full extracted label fields
application numbers
  1. NDA020715
  2. NDA021288
  3. NDA022437
boxed warning exact
    brand names
    1. Trelstar
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1b84d62-a369-a4b7-5c41-dd1f553a18f3
    generic names
    1. TRIPTORELIN PAMOATE
    id
    ac43d5b2-3223-b955-2798-555d48497798
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Verity Pharmaceuticals Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 74676-5902-1
      2. 74676-5902-0
      3. 74676-5904-1
      4. 74676-5904-0
      5. 74676-5906-1
      6. 74676-5906-0
      product ndcs
      1. 74676-5902
      2. 74676-5904
      3. 74676-5906
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.6 ) 08/2025
      record type
      complete_spl_indications_section_candidate
      routes
        rxcuis
        1. 199821
        2. 905053
        3. 905057
        4. 905059
        5. 905062
        6. 905064
        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%22ac43d5b2-3223-b955-2798-555d48497798%22
        spl effective date
        2026-06-30
        spl effective time
        20260630
        spl set id
        b1b84d62-a369-a4b7-5c41-dd1f553a18f3
        spl version
        20
        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
            4. fda_label_posted_after_spl_effective_date_requires_version_review
            Drugs@FDA application source records
            1. application number
              NDA020715
              payload
              all indexed label documents
              1. Appl No
                020715
                Application Docs Date
                2013-03-15 00:00:00
                Application Docs ID
                13278
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                30
                Submission Type
                SUPPL
              2. Appl No
                020715
                Application Docs Date
                2014-07-15 00:00:00
                Application Docs ID
                13279
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                32
                Submission Type
                SUPPL
              3. Appl No
                020715
                Application Docs Date
                2000-06-15 00:00:00
                Application Docs ID
                35208
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              4. Appl No
                020715
                Application Docs Date
                2011-01-20 00:00:00
                Application Docs ID
                35209
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                24
                Submission Type
                SUPPL
              5. Appl No
                020715
                Application Docs Date
                2011-05-23 00:00:00
                Application Docs ID
                35210
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                25
                Submission Type
                SUPPL
              6. Appl No
                020715
                Application Docs Date
                2018-12-18 00:00:00
                Application Docs ID
                56782
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                40
                Submission Type
                SUPPL
              7. Appl No
                020715
                Application Docs Date
                2023-03-06 00:00:00
                Application Docs ID
                73689
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                45
                Submission Type
                SUPPL
              8. Appl No
                020715
                Application Docs Date
                2023-11-21 00:00:00
                Application Docs ID
                76639
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                47
                Submission Type
                SUPPL
              9. Appl No
                020715
                Application Docs Date
                2024-04-15 00:00:00
                Application Docs ID
                78129
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                49
                Submission Type
                SUPPL
              10. Appl No
                020715
                Application Docs Date
                2025-03-14 00:00:00
                Application Docs ID
                81570
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                50
                Submission Type
                SUPPL
              11. Appl No
                020715
                Application Docs Date
                2025-09-25 00:00:00
                Application Docs ID
                83477
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                51
                Submission Type
                SUPPL
              12. Appl No
                020715
                Application Docs Date
                2026-07-06 00:00:00
                Application Docs ID
                86451
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                52
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                52
                Submission Status
                AP
                Submission Status Date
                2026-06-26 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                51
                Submission Status
                AP
                Submission Status Date
                2025-09-23 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                50
                Submission Status
                AP
                Submission Status Date
                2025-03-11 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                49
                Submission Status
                AP
                Submission Status Date
                2024-04-12 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                47
                Submission Status
                AP
                Submission Status Date
                2023-11-17 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                45
                Submission Status
                AP
                Submission Status Date
                2023-03-03 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                40
                Submission Status
                AP
                Submission Status Date
                2018-12-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                34
                Submission Status
                AP
                Submission Status Date
                2015-02-03 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                33
                Submission Status
                AP
                Submission Status Date
                2014-07-15 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                32
                Submission Status
                AP
                Submission Status Date
                2014-07-11 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                31
                Submission Status
                AP
                Submission Status Date
                2014-03-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              12. Appl No
                020715
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                30
                Submission Status
                AP
                Submission Status Date
                2013-03-12 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA020715
              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
              2026-06-26
              latest label selection rule
              max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
              latest posted label documents
              1. Appl No
                020715
                Application Docs Date
                2026-07-06 00:00:00
                Application Docs ID
                86451
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                52
                Submission Type
                SUPPL
              official application record
              Appl No
              020715
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              VERITY
              openfda application present
              true
              products
              1. Active Ingredient
                TRIPTORELIN PAMOATE
                Appl No
                020715
                Drug Name
                TRELSTAR
                Form
                INJECTABLE;INTRAMUSCULAR
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                EQ 3.75MG BASE/VIAL
                marketing status
                1. Prescription
            2. application number
              NDA021288
              payload
              all indexed label documents
              1. Appl No
                021288
                Application Docs Date
                2011-01-20 00:00:00
                Application Docs ID
                14901
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                21
                Submission Type
                SUPPL
              2. Appl No
                021288
                Application Docs Date
                2014-07-15 00:00:00
                Application Docs ID
                14902
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                28
                Submission Type
                SUPPL
              3. Appl No
                021288
                Application Docs Date
                2001-06-29 00:00:00
                Application Docs ID
                36591
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              4. Appl No
                021288
                Application Docs Date
                2011-05-23 00:00:00
                Application Docs ID
                36592
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                22
                Submission Type
                SUPPL
              5. Appl No
                021288
                Application Docs Date
                2013-03-15 00:00:00
                Application Docs ID
                36593
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                27
                Submission Type
                SUPPL
              6. Appl No
                021288
                Application Docs Date
                2018-12-18 00:00:00
                Application Docs ID
                56783
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                35
                Submission Type
                SUPPL
              7. Appl No
                021288
                Application Docs Date
                2023-03-06 00:00:00
                Application Docs ID
                73690
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                40
                Submission Type
                SUPPL
              8. Appl No
                021288
                Application Docs Date
                2023-11-21 00:00:00
                Application Docs ID
                76641
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                42
                Submission Type
                SUPPL
              9. Appl No
                021288
                Application Docs Date
                2024-04-15 00:00:00
                Application Docs ID
                78130
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                44
                Submission Type
                SUPPL
              10. Appl No
                021288
                Application Docs Date
                2025-03-14 00:00:00
                Application Docs ID
                81571
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                45
                Submission Type
                SUPPL
              11. Appl No
                021288
                Application Docs Date
                2025-09-25 00:00:00
                Application Docs ID
                83478
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                46
                Submission Type
                SUPPL
              12. Appl No
                021288
                Application Docs Date
                2026-07-06 00:00:00
                Application Docs ID
                86452
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                47
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                47
                Submission Status
                AP
                Submission Status Date
                2026-06-26 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                46
                Submission Status
                AP
                Submission Status Date
                2025-09-23 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                45
                Submission Status
                AP
                Submission Status Date
                2025-03-11 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                44
                Submission Status
                AP
                Submission Status Date
                2024-04-12 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                42
                Submission Status
                AP
                Submission Status Date
                2023-11-17 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                40
                Submission Status
                AP
                Submission Status Date
                2023-03-03 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                35
                Submission Status
                AP
                Submission Status Date
                2018-12-14 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                29
                Submission Status
                AP
                Submission Status Date
                2014-07-15 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                28
                Submission Status
                AP
                Submission Status Date
                2014-07-11 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                27
                Submission Status
                AP
                Submission Status Date
                2013-03-12 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                021288
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                24
                Submission Status
                AP
                Submission Status Date
                2013-04-25 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              12. Appl No
                021288
                Review Priority
                UNKNOWN
                Submission Class Code ID
                3
                Submission No
                22
                Submission Status
                AP
                Submission Status Date
                2011-05-19 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA021288
              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
              2026-06-26
              latest label selection rule
              max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
              latest posted label documents
              1. Appl No
                021288
                Application Docs Date
                2026-07-06 00:00:00
                Application Docs ID
                86452
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                47
                Submission Type
                SUPPL
              official application record
              Appl No
              021288
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              VERITY
              openfda application present
              true
              products
              1. Active Ingredient
                TRIPTORELIN PAMOATE
                Appl No
                021288
                Drug Name
                TRELSTAR
                Form
                INJECTABLE;INTRAMUSCULAR
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                EQ 11.25MG BASE/VIAL
                marketing status
                1. Prescription
            3. application number
              NDA022437
              payload
              all indexed label documents
              1. Appl No
                022437
                Application Docs Date
                2011-05-23 00:00:00
                Application Docs ID
                17591
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                3
                Submission Type
                SUPPL
              2. Appl No
                022437
                Application Docs Date
                2013-03-15 00:00:00
                Application Docs ID
                17592
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                7
                Submission Type
                SUPPL
              3. Appl No
                022437
                Application Docs Date
                2014-07-15 00:00:00
                Application Docs ID
                17593
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                8
                Submission Type
                SUPPL
              4. Appl No
                022437
                Application Docs Date
                2010-03-17 00:00:00
                Application Docs ID
                38714
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              5. Appl No
                022437
                Application Docs Date
                2011-01-20 00:00:00
                Application Docs ID
                38715
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                2
                Submission Type
                SUPPL
              6. Appl No
                022437
                Application Docs Date
                2018-12-18 00:00:00
                Application Docs ID
                56784
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                15
                Submission Type
                SUPPL
              7. Appl No
                022437
                Application Docs Date
                2023-03-06 00:00:00
                Application Docs ID
                73691
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                20
                Submission Type
                SUPPL
              8. Appl No
                022437
                Application Docs Date
                2023-11-21 00:00:00
                Application Docs ID
                76642
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                22
                Submission Type
                SUPPL
              9. Appl No
                022437
                Application Docs Date
                2024-04-15 00:00:00
                Application Docs ID
                78131
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                24
                Submission Type
                SUPPL
              10. Appl No
                022437
                Application Docs Date
                2025-03-14 00:00:00
                Application Docs ID
                81572
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                25
                Submission Type
                SUPPL
              11. Appl No
                022437
                Application Docs Date
                2025-09-25 00:00:00
                Application Docs ID
                83476
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                26
                Submission Type
                SUPPL
              12. Appl No
                022437
                Application Docs Date
                2026-07-06 00:00:00
                Application Docs ID
                86453
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                27
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                022437
                Review Priority
                STANDARD
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                Review Priority
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                Submission No
                2
                Submission Status
                AP
                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
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                Submission No
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                Submission Status
                AP
                Submission Status Date
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                Submissions Public Notes
              4. Appl No
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                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                4
                Submission Status
                AP
                Submission Status Date
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                Submissions Public Notes
              5. Appl No
                022437
                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                5
                Submission Status
                AP
                Submission Status Date
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              6. Appl No
                022437
                Review Priority
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                Submission Class Code ID
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                Submission No
                6
                Submission Status
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              7. Appl No
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                Submission Class Code ID
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                Submission No
                7
                Submission Status
                AP
                Submission Status Date
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                Submissions Public Notes
              8. Appl No
                022437
                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                8
                Submission Status
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                Submissions Public Notes
              9. Appl No
                022437
                Review Priority
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                Submission Class Code ID
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                Submission No
                9
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                STANDARD
                Submission Class Code ID
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                2026-06-26 00:00:00
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                Submission No
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                          Preserved source evidence · Not medical advice