Quick answers
- What is Leuprolide acetate used for?
- The FDA-approved label (Vabrinty, Uronova Pharmaceuticals, Inc., April 30, 2026) says: “VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Leuprolide acetate have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Leuprolide acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Leuprolide acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Leuprolide acetate?
- 3 companies list prescription products of Leuprolide acetate in the FDA NDC Directory, including TOLMAR Inc., Uronova Pharmaceuticals, Inc. and Endo USA, Inc..
What Leuprolide acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.
— FDA label: Vabrinty, Uronova Pharmaceuticals, Inc., effective April 30, 2026. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- TOLMAR Inc.5 products
- Uronova Pharmaceuticals, Inc.4 products
- Endo USA, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021343 ELIGARD KIT | Tolmar | January 23, 2002 | 24, latest May 6, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
| NDA021379 ELIGARD KIT | Tolmar | July 24, 2002 | 21, latest May 6, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
| NDA021488 ELIGARD KIT | Tolmar | February 13, 2003 | 16, latest May 6, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
| NDA021731 ELIGARD KIT | Tolmar | December 14, 2004 | 19, latest May 6, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
| NDA213150 FENSOLVI KIT | Tolmar | May 1, 2020 | 5, latest September 23, 2025 2025: Labeling · 2025: Labeling · 2024: Labeling |
Generic approvals (1)
- ANDA217437Ph Health · June 9, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 545835, 752884, 752889, 752894, 752899, 825325, 825333, 825334, 825335, 2371773 … (+4) |
|---|---|
| SPL set ID of the quoted label | 008776cc-83f1-4f8c-819b-6471425da15f |
| FDA labels (SPL) | 4 |
| FDA applications | NDA021343, NDA021379, NDA021488, NDA021731, NDA213150, 1 ANDA |
| Active ingredients (FDA) | LEUPROLIDE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vabrinty, Uronova Pharmaceuticals, Inc., effective April 30, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →