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LABELS · 15d87847-b4c3-48bc-8c40-d8fc63fcb1b0

LEUPROLIDE ACETATE DEPOT

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
2024-08-27
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
Full extracted label fields
application numbers
  1. NDA205054
boxed warning exact
    brand names
    1. LEUPROLIDE ACETATE DEPOT
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1563a30b-66e0-445d-ba3e-1ccd5218133f
    generic names
    1. LEUPROLIDE ACETATE
    id
    15d87847-b4c3-48bc-8c40-d8fc63fcb1b0
    indications and usage exact
    1. 1. INDICATIONS AND USAGE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. CIPLA USA INC.
      matched search terms
      1. cancer
      package ndcs
      1. 69097-909-50
      2. 69097-950-32
      3. 69097-960-31
      product ndcs
      1. 69097-909
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.2 ) 08/2024
      record type
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        meta
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        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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            1. application number
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              payload
              all indexed label documents
              1. Appl No
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                Application Docs Date
                2018-10-22 00:00:00
                Application Docs ID
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                Application Docs Title
                0
                Application Docs Type ID
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                Submission No
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                Application Docs Date
                2023-03-01 00:00:00
                Application Docs ID
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                0
                Application Docs Type ID
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                Submission No
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                Submission Type
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              3. Appl No
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                Application Docs Date
                2023-12-01 00:00:00
                Application Docs ID
                76709
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                5
                Submission Type
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              4. Appl No
                205054
                Application Docs Date
                2024-08-12 00:00:00
                Application Docs ID
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                Application Docs Title
                0
                Application Docs Type ID
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                Submission No
                6
                Submission Type
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              5. Appl No
                205054
                Application Docs Date
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                Application Docs ID
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                Application Docs Title
                0
                Application Docs Type ID
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                Submission No
                7
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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
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                Submission Status Date
                2018-08-28 00:00:00
                Submission Type
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              2. Appl No
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                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                4
                Submission Status
                AP
                Submission Status Date
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                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
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                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                5
                Submission Status
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                Submission Status Date
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                Submission Type
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                Submissions Public Notes
              4. Appl No
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                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                6
                Submission Status
                AP
                Submission Status Date
                2024-08-08 00:00:00
                Submission Type
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                Submissions Public Notes
              5. Appl No
                205054
                Review Priority
                STANDARD
                Submission Class Code ID
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                Submission No
                7
                Submission Status
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                Submission Status Date
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                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
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              latest approved submission date
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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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                Application Docs Title
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                Application Docs Type 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
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              Sponsor Name
              INVAGEN PHARMS
              openfda application present
              true
              products
              1. Active Ingredient
                LEUPROLIDE ACETATE
                Appl No
                205054
                Drug Name
                LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
                Form
                FOR SUSPENSION;INTRAMUSCULAR
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                22.5MG/VIAL
                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 · unclassified context
            application numbers
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            brand names
            1. LEUPROLIDE ACETATE DEPOT
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            1. INDICATIONS AND USAGE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LEUPROLIDE ACETATE FOR DE
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                  1. INDICATIONS AND USAGE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
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                      INDICATIONS AND USAGE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer.
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                      1. INDICATIONS AND USAGE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
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                          LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer.
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                          s indicated for treatment of advanced prostate cancer. LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )
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                                Preserved source evidence · Not medical advice