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LABELS · bc6c62ea-da7b-4c27-a88e-c80cfcd7856d

Jalyn

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-03-09
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE JALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
Full extracted label fields
application numbers
  1. NDA022460
boxed warning exact
    brand names
    1. Jalyn
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aab9a2d4-5328-40f3-986f-e7753a928bc0
    generic names
    1. DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
    id
    bc6c62ea-da7b-4c27-a88e-c80cfcd7856d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE JALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Waylis Therapeutics
      matched search terms
      1. cancer
      package ndcs
      1. 80725-809-13
      2. 80725-809-59
      product ndcs
      1. 80725-809
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Contraindications ( 4 ) 12/2020
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 996097
      2. 996101
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00600.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
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      skip
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      total
      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22bc6c62ea-da7b-4c27-a88e-c80cfcd7856d%22
      spl effective date
      2026-03-09
      spl effective time
      20260309
      spl set id
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      spl version
      4
      substance names
      1. DUTASTERIDE
      2. TAMSULOSIN HYDROCHLORIDE
      uniis
      1. O0J6XJN02I
      2. 11SV1951MR
      verification flags
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      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA022460
        payload
        all indexed label documents
        1. Appl No
          022460
          Application Docs Date
          2010-06-15 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          022460
          Application Docs Date
          2011-06-10 00:00:00
          Application Docs ID
          17601
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          022460
          Application Docs Date
          2012-06-28 00:00:00
          Application Docs ID
          17602
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          022460
          Application Docs Date
          2013-04-29 00:00:00
          Application Docs ID
          17603
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        5. Appl No
          022460
          Application Docs Date
          2013-04-29 00:00:00
          Application Docs ID
          38731
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        6. Appl No
          022460
          Application Docs Date
          2013-04-29 00:00:00
          Application Docs ID
          38732
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        7. Appl No
          022460
          Application Docs Date
          2017-11-03 00:00:00
          Application Docs ID
          50289
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        8. Appl No
          022460
          Application Docs Date
          2017-11-03 00:00:00
          Application Docs ID
          50290
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        9. Appl No
          022460
          Application Docs Date
          2021-01-06 00:00:00
          Application Docs ID
          65774
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          022460
          Review Priority
          STANDARD
          Submission Class Code ID
          14
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2010-06-14 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          022460
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2011-06-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          022460
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2012-06-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          022460
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2013-04-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          022460
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2013-04-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          022460
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2013-04-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          022460
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2017-11-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          022460
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2017-11-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          022460
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2016-06-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          022460
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2020-12-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA022460
        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
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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
          022460
          Application Docs Date
          2021-01-06 00:00:00
          Application Docs ID
          65774
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          11
          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        WAYLIS THERAP
        openfda application present
        true
        products
        1. Active Ingredient
          DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
          Appl No
          022460
          Drug Name
          JALYN
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          0.5MG;0.4MG
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. NDA022460
      brand names
      1. Jalyn
      classification reasons
      1. explicit_positive_indication_predicate
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      clinical review status
      pending
      content role
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      context span
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      453
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE JALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (d
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      exact text
      is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated
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        regulatory links
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            exact text
            1 INDICATIONS AND USAGE JALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
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            spl effective date
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            structured fields status
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            approval pathway
            Source null
            biomarker and test
            Source null
            disease stage
            Source null
            limitations
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            line
            Source null
            prior therapy
            Source null
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            tumor histology
            Source null
            use intent
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            Passage 2 · limitation of use
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            clinical review status
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            true
            exact text
            steride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
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                  ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
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                  ign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Lim
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                        tatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
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                              1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
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                              ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
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                              1. DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
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                                    1.2 Limitations of Use Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
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                                    Preserved source evidence · Not medical advice