FDA label
What is leuprolide acetate used for?
The FDA-approved uses of leuprolide acetate, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.”
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Leuprolide Acetate, injection
Indications and Usage, quoted from the label by Endo USA, Inc. (ANDA217437). Cross-references to other label sections are left out.
Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
Source: DailyMed label, set id 290b0716-2fd5-43a1-8d3c-4857c1b2eefa, version 7, effective June 10, 2024. NDC 42023-259, one of 1 listing for this product.
Questions
What is leuprolide acetate used for?
The FDA label says: “Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.”
What drug class is leuprolide acetate?
FDA lists leuprolide acetate in the Gonadotropin Releasing Hormone Receptor Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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