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LABELS · a7c38eaa-3f9a-4b24-8634-bdac6138f983

ZOLADEX

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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
2026-03-24
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Use as palliative treatment of advanced carcinoma of the prostate ( 1.2 ) 1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14.1 )]. 1.2 Prostatic Carcinoma ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )]. In controlled studies of patients with advanced prostatic cancer comparing ZOLADEX 3.6 mg to orchiectomy, the long-term endocrine responses and objective responses were similar between the two treatment arms. Additionally, duration of survival was similar between the two treatment arms in a major comparative trial. In controlled studies of patients with advanced prostatic cancer, ZOLADEX 10.8 mg implant produced pharmacodynamically similar effect in terms of suppression of serum testosterone to that achieved with ZOLADEX 3.6 mg implant. Clinical outcome similar to that produced with the use of the ZOLADEX 3.6 mg implant administered every 28 days is predicted with the ZOLADEX 10.8 mg implant administered every 12 weeks. The automatic safety feature of the syringe aids in the prevention of needlestick injury.
Full extracted label fields
application numbers
  1. NDA020578
boxed warning exact
    brand names
    1. ZOLADEX
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4cb3c20-2738-400a-b522-3f36f71fe6c5
    generic names
    1. GOSERELIN
    id
    a7c38eaa-3f9a-4b24-8634-bdac6138f983
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Use as palliative treatment of advanced carcinoma of the prostate ( 1.2 ) 1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14.1 )]. 1.2 Prostatic Carcinoma ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )]. In controlled studies of patients with advanced prostatic cancer comparing ZOLADEX 3.6 mg to orchiectomy, the long-term endocrine responses and objective responses were similar between the two treatment arms. Additionally, duration of survival was similar between the two treatment arms in a major comparative trial. In controlled studies of patients with advanced prostatic cancer, ZOLADEX 10.8 mg implant produced pharmacodynamically similar effect in terms of suppression of serum testosterone to that achieved with ZOLADEX 3.6 mg implant. Clinical outcome similar to that produced with the use of the ZOLADEX 3.6 mg implant administered every 28 days is predicted with the ZOLADEX 10.8 mg implant administered every 12 weeks. The automatic safety feature of the syringe aids in the prevention of needlestick injury.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. TerSera Therapeutics LLC
      matched search terms
      1. cancer
      2. carcinoma
      package ndcs
      1. 70720-951-30
      product ndcs
      1. 70720-951
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.5 ) 9/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 211544
      2. 314008
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      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
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      url
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      source url
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      spl effective date
      2026-03-24
      spl effective time
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      substance names
      1. GOSERELIN ACETATE
      uniis
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      Drugs@FDA application source records
      1. application number
        NDA020578
        payload
        all indexed label documents
        1. Appl No
          020578
          Application Docs Date
          1998-07-27 00:00:00
          Application Docs ID
          12760
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        2. Appl No
          020578
          Application Docs Date
          2009-09-17 00:00:00
          Application Docs ID
          12761
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          29
          Submission Type
          SUPPL
        3. Appl No
          020578
          Application Docs Date
          2011-01-20 00:00:00
          Application Docs ID
          12762
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        4. Appl No
          020578
          Application Docs Date
          2013-06-17 00:00:00
          Application Docs ID
          12763
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          34
          Submission Type
          SUPPL
        5. Appl No
          020578
          Application Docs Date
          2013-06-17 00:00:00
          Application Docs ID
          12764
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          35
          Submission Type
          SUPPL
        6. Appl No
          020578
          Application Docs Date
          2014-10-09 00:00:00
          Application Docs ID
          12765
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          36
          Submission Type
          SUPPL
        7. Appl No
          020578
          Application Docs Date
          2009-09-17 00:00:00
          Application Docs ID
          34874
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          28
          Submission Type
          SUPPL
        8. Appl No
          020578
          Application Docs Date
          2009-09-17 00:00:00
          Application Docs ID
          34875
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          30
          Submission Type
          SUPPL
        9. Appl No
          020578
          Application Docs Date
          2015-02-13 00:00:00
          Application Docs ID
          34876
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          37
          Submission Type
          SUPPL
        10. Appl No
          020578
          Application Docs Date
          2024-10-21 00:00:00
          Application Docs ID
          79916
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          44
          Submission Type
          SUPPL
        11. Appl No
          020578
          Application Docs Date
          2025-09-25 00:00:00
          Application Docs ID
          83481
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          51
          Submission Type
          SUPPL
        12. Appl No
          020578
          Application Docs Date
          2026-05-12 00:00:00
          Application Docs ID
          85885
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          53
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          53
          Submission Status
          AP
          Submission Status Date
          2026-05-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          51
          Submission Status
          AP
          Submission Status Date
          2025-09-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          44
          Submission Status
          AP
          Submission Status Date
          2021-06-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          37
          Submission Status
          AP
          Submission Status Date
          2015-02-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          36
          Submission Status
          AP
          Submission Status Date
          2014-10-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          35
          Submission Status
          AP
          Submission Status Date
          2013-06-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          34
          Submission Status
          AP
          Submission Status Date
          2013-06-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          020578
          Review Priority
          901 REQUIRED
          Submission Class Code ID
          3
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2011-01-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          30
          Submission Status
          AP
          Submission Status Date
          2009-08-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2009-08-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          28
          Submission Status
          AP
          Submission Status Date
          2009-08-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          020578
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          25
          Submission Status
          AP
          Submission Status Date
          2005-10-19 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
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        approval interpretation
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        current indication status
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        has approved submission record
        true
        latest approved submission date
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        1. Appl No
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          Application Docs Date
          2026-05-12 00:00:00
          Application Docs ID
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          Submission No
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        TERSERA
        openfda application present
        true
        products
        1. Active Ingredient
          GOSERELIN ACETATE
          Appl No
          020578
          Drug Name
          ZOLADEX
          Form
          IMPLANT;IMPLANTATION
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 10.8MG BASE
          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
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      brand names
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      1 INDICATIONS AND USAGE ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Use as palliative treatment of advanced carcinoma of the prostate ( 1.2 ) 1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment wit
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      is a Gonadotropin Releasing Hormone (GnRH) agonist indicated
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        otropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Use as palliative treatment of advanced carcinoma of th
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        in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1
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          1 INDICATIONS AND USAGE ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Use as palliative treatment of advanced carcinoma of the prostate ( 1.2 )
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          ist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Use as palliative treatment of advanced carcinoma of the prostate ( 1.2 ) 1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14.
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            Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.
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            in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate
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              1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.
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                                                  1671
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                                                  true
                                                  exact text
                                                  The automatic safety feature of the syringe aids in the prevention of needlestick injury.
                                                  label id
                                                  a7c38eaa-3f9a-4b24-8634-bdac6138f983
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  218b85cbcbb7c96656324b3d3fc81c2df28a9f4aae6fb730e951a4e6df06256d
                                                  start
                                                  1582
                                                  source url
                                                  https://api.fda.gov/drug/label.json?search=id%3A%22a7c38eaa-3f9a-4b24-8634-bdac6138f983%22
                                                  spl effective date
                                                  2026-03-24
                                                  spl set id
                                                  e4cb3c20-2738-400a-b522-3f36f71fe6c5
                                                  spl version
                                                  8
                                                  structured fields status
                                                  not_extracted_no_values_inferred_from_mentions
                                                  structured indication
                                                  age
                                                  Source null
                                                  approval pathway
                                                  Source null
                                                  biomarker and test
                                                  Source null
                                                  disease stage
                                                  Source null
                                                  limitations
                                                  Source null
                                                  line
                                                  Source null
                                                  prior therapy
                                                  Source null
                                                  regimen
                                                  Source null
                                                  tumor histology
                                                  Source null
                                                  use intent
                                                  unclear

                                                  Preserved source evidence · Not medical advice