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LABELS · 27e114f0-8c42-47c3-bcb8-0da93eb9a5fb

Vabrinty

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
2026-04-30
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )
Full extracted label fields
application numbers
  1. NDA021379
  2. NDA021488
  3. NDA021731
  4. NDA021343
boxed warning exact
    brand names
    1. Vabrinty
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=008776cc-83f1-4f8c-819b-6471425da15f
    generic names
    1. LEUPROLIDE ACETATE
    id
    27e114f0-8c42-47c3-bcb8-0da93eb9a5fb
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY 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. URONOVA PHARMACEUTICALS, INC.
      matched search terms
      1. cancer
      package ndcs
      1. 85043-025-02
      2. 85043-045-04
      3. 85043-030-03
      4. 85043-075-05
      5. 85043-075-50
      product ndcs
      1. 85043-025
      2. 85043-045
      3. 85043-030
      4. 85043-075
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. RECENT MAJOR CHANGES Warnings and Precautions ( 5.6 ) 02/2025 Dosage and Administration ( 2 ) 02/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 752889
      2. 752894
      3. 752899
      4. 2720345
      5. 2720348
      6. 2723399
      7. 2728996
      8. 752884
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00100.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
      100
      total
      830
      sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      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=100&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%2227e114f0-8c42-47c3-bcb8-0da93eb9a5fb%22
      spl effective date
      2026-04-30
      spl effective time
      20260430
      spl set id
      008776cc-83f1-4f8c-819b-6471425da15f
      spl version
      10
      substance names
      1. LEUPROLIDE ACETATE
      uniis
      1. 37JNS02E7V
      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
        NDA021343
        payload
        all indexed label documents
        1. Appl No
          021343
          Application Docs Date
          2011-01-20 00:00:00
          Application Docs ID
          15223
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        2. Appl No
          021343
          Application Docs Date
          2013-03-01 00:00:00
          Application Docs ID
          15224
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          27
          Submission Type
          SUPPL
        3. Appl No
          021343
          Application Docs Date
          2016-03-03 00:00:00
          Application Docs ID
          15225
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          33
          Submission Type
          SUPPL
        4. Appl No
          021343
          Application Docs Date
          2002-01-23 00:00:00
          Application Docs ID
          36695
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        5. Appl No
          021343
          Application Docs Date
          2007-11-13 00:00:00
          Application Docs ID
          36696
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        6. Appl No
          021343
          Application Docs Date
          2010-10-12 00:00:00
          Application Docs ID
          36697
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        7. Appl No
          021343
          Application Docs Date
          2011-04-11 00:00:00
          Application Docs ID
          36698
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        8. Appl No
          021343
          Application Docs Date
          2014-10-15 00:00:00
          Application Docs ID
          36699
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          30
          Submission Type
          SUPPL
        9. Appl No
          021343
          Application Docs Date
          2019-02-19 00:00:00
          Application Docs ID
          57696
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          39
          Submission Type
          SUPPL
        10. Appl No
          021343
          Application Docs Date
          2023-07-21 00:00:00
          Application Docs ID
          74856
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          48
          Submission Type
          SUPPL
        11. Appl No
          021343
          Application Docs Date
          2023-07-21 00:00:00
          Application Docs ID
          74858
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          47
          Submission Type
          SUPPL
        12. Appl No
          021343
          Application Docs Date
          2024-01-25 00:00:00
          Application Docs ID
          77293
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          51
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          60
          Submission Status
          AP
          Submission Status Date
          2026-05-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          56
          Submission Status
          AP
          Submission Status Date
          2025-02-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          55
          Submission Status
          AP
          Submission Status Date
          2025-02-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          52
          Submission Status
          AP
          Submission Status Date
          2024-05-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          51
          Submission Status
          AP
          Submission Status Date
          2024-01-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          48
          Submission Status
          AP
          Submission Status Date
          2023-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          47
          Submission Status
          AP
          Submission Status Date
          2023-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          39
          Submission Status
          AP
          Submission Status Date
          2019-02-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          34
          Submission Status
          AP
          Submission Status Date
          2017-01-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          33
          Submission Status
          AP
          Submission Status Date
          2016-02-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2015-10-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          021343
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          31
          Submission Status
          AP
          Submission Status Date
          2014-10-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA021343
        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
        2026-05-06
        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
          021343
          Application Docs Date
          2026-05-12 00:00:00
          Application Docs ID
          85887
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          60
          Submission Type
          SUPPL
        official application record
        Appl No
        021343
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        TOLMAR
        openfda application present
        true
        products
        1. Active Ingredient
          LEUPROLIDE ACETATE
          Appl No
          021343
          Drug Name
          ELIGARD KIT
          Form
          POWDER;SUBCUTANEOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          7.5MG
          marketing status
          1. Prescription
      2. application number
        NDA021379
        payload
        all indexed label documents
        1. Appl No
          021379
          Application Docs Date
          2002-07-24 00:00:00
          Application Docs ID
          15342
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          021379
          Application Docs Date
          2007-11-13 00:00:00
          Application Docs ID
          15343
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        3. Appl No
          021379
          Application Docs Date
          2010-10-12 00:00:00
          Application Docs ID
          15344
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        4. Appl No
          021379
          Application Docs Date
          2011-01-20 00:00:00
          Application Docs ID
          15345
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        5. Appl No
          021379
          Application Docs Date
          2014-10-15 00:00:00
          Application Docs ID
          15346
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          30
          Submission Type
          SUPPL
        6. Appl No
          021379
          Application Docs Date
          2016-03-03 00:00:00
          Application Docs ID
          15347
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          33
          Submission Type
          SUPPL
        7. Appl No
          021379
          Application Docs Date
          2011-04-11 00:00:00
          Application Docs ID
          36800
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        8. Appl No
          021379
          Application Docs Date
          2013-03-01 00:00:00
          Application Docs ID
          36801
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          25
          Submission Type
          SUPPL
        9. Appl No
          021379
          Application Docs Date
          2019-02-19 00:00:00
          Application Docs ID
          57699
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          41
          Submission Type
          SUPPL
        10. Appl No
          021379
          Application Docs Date
          2023-07-21 00:00:00
          Application Docs ID
          74859
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          49
          Submission Type
          SUPPL
        11. Appl No
          021379
          Application Docs Date
          2023-07-21 00:00:00
          Application Docs ID
          74860
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          50
          Submission Type
          SUPPL
        12. Appl No
          021379
          Application Docs Date
          2024-01-25 00:00:00
          Application Docs ID
          77294
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          53
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          65
          Submission Status
          AP
          Submission Status Date
          2026-05-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          59
          Submission Status
          AP
          Submission Status Date
          2025-02-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          58
          Submission Status
          AP
          Submission Status Date
          2025-02-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          55
          Submission Status
          AP
          Submission Status Date
          2024-05-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          53
          Submission Status
          AP
          Submission Status Date
          2024-01-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          50
          Submission Status
          AP
          Submission Status Date
          2023-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          49
          Submission Status
          AP
          Submission Status Date
          2023-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          41
          Submission Status
          AP
          Submission Status Date
          2019-02-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          33
          Submission Status
          AP
          Submission Status Date
          2016-02-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          30
          Submission Status
          AP
          Submission Status Date
          2014-10-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          28
          Submission Status
          AP
          Submission Status Date
          2014-04-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          021379
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          27
          Submission Status
          AP
          Submission Status Date
          2014-02-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA021379
        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
        2026-05-06
        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
          021379
          Application Docs Date
          2026-05-12 00:00:00
          Application Docs ID
          85888
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          65
          Submission Type
          SUPPL
        official application record
        Appl No
        021379
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        TOLMAR
        openfda application present
        true
        products
        1. Active Ingredient
          LEUPROLIDE ACETATE
          Appl No
          021379
          Drug Name
          ELIGARD KIT
          Form
          POWDER;SUBCUTANEOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          22.5MG
          marketing status
          1. Prescription
      3. application number
        NDA021488
        payload
        all indexed label documents
        1. Appl No
          021488
          Application Docs Date
          2010-10-12 00:00:00
          Application Docs ID
          15586
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        2. Appl No
          021488
          Application Docs Date
          2011-01-20 00:00:00
          Application Docs ID
          15587
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        3. Appl No
          021488
          Application Docs Date
          2011-04-11 00:00:00
          Application Docs ID
          15588
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        4. Appl No
          021488
          Application Docs Date
          2013-03-01 00:00:00
          Application Docs ID
          15589
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          25
          Submission Type
          SUPPL
        5. Appl No
          021488
          Application Docs Date
          2003-02-13 00:00:00
          Application Docs ID
          37055
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        6. Appl No
          021488
          Application Docs Date
          2007-11-13 00:00:00
          Application Docs ID
          37056
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        7. Appl No
          021488
          Application Docs Date
          2014-10-15 00:00:00
          Application Docs ID
          37057
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          27
          Submission Type
          SUPPL
        8. Appl No
          021488
          Application Docs Date
          2016-03-03 00:00:00
          Application Docs ID
          37058
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          30
          Submission Type
          SUPPL
        9. Appl No
          021488
          Application Docs Date
          2019-02-19 00:00:00
          Application Docs ID
          57698
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          36
          Submission Type
          SUPPL
        10. Appl No
          021488
          Application Docs Date
          2023-07-21 00:00:00
          Application Docs ID
          74861
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          44
          Submission Type
          SUPPL
        11. Appl No
          021488
          Application Docs Date
          2023-07-21 00:00:00
          Application Docs ID
          74862
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          45
          Submission Type
          SUPPL
        12. Appl No
          021488
          Application Docs Date
          2024-01-25 00:00:00
          Application Docs ID
          77295
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          48
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2003-02-13 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2004-01-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2007-11-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          021488
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2010-10-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          021488
          Review Priority
          901 REQUIRED
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2011-01-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          021488
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2011-04-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          25
          Submission Status
          AP
          Submission Status Date
          2013-02-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          27
          Submission Status
          AP
          Submission Status Date
          2014-10-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          30
          Submission Status
          AP
          Submission Status Date
          2016-02-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          36
          Submission Status
          AP
          Submission Status Date
          2019-02-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          44
          Submission Status
          AP
          Submission Status Date
          2023-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          021488
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          45
          Submission Status
          AP
          Submission Status Date
          2023-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
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        approval interpretation
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        has approved submission record
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        latest approved submission date
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        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
          021488
          Application Docs Date
          2026-05-12 00:00:00
          Application Docs ID
          85889
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          57
          Submission Type
          SUPPL
        official application record
        Appl No
        021488
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        TOLMAR
        openfda application present
        true
        products
        1. Active Ingredient
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          Drug Name
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          Form
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          Product No
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          Reference Drug
          1
          Reference Standard
          1
          Strength
          30MG
          marketing status
          1. Prescription
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        NDA021731
        payload
        all indexed label documents
        1. Appl No
          021731
          Application Docs Date
          2007-11-13 00:00:00
          Application Docs ID
          16275
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        2. Appl No
          021731
          Application Docs Date
          2011-01-20 00:00:00
          Application Docs ID
          16276
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        3. Appl No
          021731
          Application Docs Date
          2010-10-12 00:00:00
          Application Docs ID
          37548
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        4. Appl No
          021731
          Application Docs Date
          2011-04-11 00:00:00
          Application Docs ID
          37549
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        5. Appl No
          021731
          Application Docs Date
          2013-03-01 00:00:00
          Application Docs ID
          37550
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          23
          Submission Type
          SUPPL
        6. Appl No
          021731
          Application Docs Date
          2014-10-15 00:00:00
          Application Docs ID
          37551
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          27
          Submission Type
          SUPPL
        7. Appl No
          021731
          Application Docs Date
          2016-03-03 00:00:00
          Application Docs ID
          37552
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          29
          Submission Type
          SUPPL
        8. Appl No
          021731
          Application Docs Date
          2019-02-19 00:00:00
          Application Docs ID
          57697
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          37
          Submission Type
          SUPPL
        9. Appl No
          021731
          Application Docs Date
          2023-07-21 00:00:00
          Application Docs ID
          74863
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          44
          Submission Type
          SUPPL
        10. Appl No
          021731
          Application Docs Date
          2023-07-21 00:00:00
          Application Docs ID
          74864
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          47
          Submission Type
          SUPPL
        11. Appl No
          021731
          Application Docs Date
          2024-01-25 00:00:00
          Application Docs ID
          77296
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          51
          Submission Type
          SUPPL
        12. Appl No
          021731
          Application Docs Date
          2024-05-22 00:00:00
          Application Docs ID
          78533
          Application Docs Title
          0
          Application Docs Type ID
          2
          Application Docs URL
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          52
          Submission Type
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          62
          Submission Status
          AP
          Submission Status Date
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          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          56
          Submission Status
          AP
          Submission Status Date
          2025-02-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          55
          Submission Status
          AP
          Submission Status Date
          2025-02-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          52
          Submission Status
          AP
          Submission Status Date
          2024-05-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          51
          Submission Status
          AP
          Submission Status Date
          2024-01-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          47
          Submission Status
          AP
          Submission Status Date
          2023-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          44
          Submission Status
          AP
          Submission Status Date
          2023-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          43
          Submission Status
          AP
          Submission Status Date
          2022-11-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          37
          Submission Status
          AP
          Submission Status Date
          2019-02-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
          AP
          Submission Status Date
          2016-02-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          27
          Submission Status
          AP
          Submission Status Date
          2014-10-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          021731
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
          AP
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        current indication status
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        has approved submission record
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        latest approved submission date
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        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
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          Application Docs Date
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          Application Docs ID
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          Application Docs Type ID
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          Submission No
          62
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          SUPPL
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        Appl Type
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      Source passages and status connections

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                    Preserved source evidence · Not medical advice