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LABELS · 2bea4c81-66a2-4817-9440-5f5da8dea04a

ELIGARD

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
2019-04-29
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 ELIGARD ® is indicated for the palliative treatment of advanced prostate cancer. ELIGARD ® is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative 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. ELIGARD
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b78d1919-9dee-44fa-90f9-e0a26d32481d
    generic names
    1. LEUPROLIDE ACETATE
    id
    2bea4c81-66a2-4817-9440-5f5da8dea04a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ELIGARD ® is indicated for the palliative treatment of advanced prostate cancer. ELIGARD ® is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. TOLMAR Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 62935-753-75
      2. 62935-754-74
      3. 62935-755-75
      4. 62935-223-05
      5. 62935-221-04
      6. 62935-224-05
      7. 62935-303-30
      8. 62935-305-29
      9. 62935-304-30
      10. 62935-453-45
      11. 62935-454-44
      12. 62935-455-45
      product ndcs
      1. 62935-223
      2. 62935-753
      3. 62935-303
      4. 62935-453
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. RECENT MAJOR CHANGES Dosage and Administration, Administration Procedure (2.2) 04/2019 Warnings and Precautions, Embryo-Fetal Toxicity ( 5.6 ) 02/2019
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 752884
      2. 752889
      3. 752894
      4. 752899
      5. 825325
      6. 825333
      7. 825334
      8. 825335
      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%222bea4c81-66a2-4817-9440-5f5da8dea04a%22
      spl effective date
      2019-04-29
      spl effective time
      20190429
      spl set id
      b78d1919-9dee-44fa-90f9-e0a26d32481d
      spl version
      51
      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
            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
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            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
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            Appl Type
            NDA
            Sponsor Name
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            true
            products
            1. Active Ingredient
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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
              SUPPL
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            1. 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
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              Submission Type
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              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
              021731
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              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
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              Submission No
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              Submission Status
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            approval interpretation
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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
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            1. Appl No
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              Application Docs Date
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              Application Docs ID
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                  Preserved source evidence · Not medical advice