Eligard Kit

Treats advanced prostate cancer. NDA 21488, held by Tolmar. Leuprolide Acetate.

As of Nov 15, 2026, NDA 21488 (Eligard Kit), held by Tolmar, was first approved by FDA on Feb 13, 2003, with 16 approved supplements and 0 published complete response letters.

First approved: Feb 13, 2003
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VABRINTY is indicated for the treatment of advanced prostate cancer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Jul 20, 2023	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 20, 2023	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 13, 2003	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eligard Kit30MG · powder;subcutaneous	Leuprolide Acetate	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


May 6, 2026	Supplement 57Labeling · Standard review	Approved	Label Letter
Feb 24, 2025	Supplement 53Labeling · Standard review	Approved	Label Letter
Feb 4, 2025	Supplement 52Labeling · Standard review	Approved	Letter Label
May 21, 2024	Supplement 50Labeling · Standard review	Approved	Label Letter
Jan 23, 2024	Supplement 48Labeling · Standard review	Approved	Label Letter
Jul 20, 2023	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 20, 2023	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 15, 2019	Supplement 36Labeling · Standard review	Approved	Letter Label
Feb 29, 2016	Supplement 30Labeling · Standard review	Approved	Label Letter
Oct 10, 2014	Supplement 27Labeling · Standard review	Approved	Label Letter
Feb 27, 2013	Supplement 25Labeling · Standard review	Approved	Label Letter
Apr 8, 2011	Supplement 17Labeling	Approved	Label Letter
Jan 14, 2011	Supplement 16Labeling	Approved	Label Letter
Oct 5, 2010	Supplement 15Labeling	Approved	Letter Label
Nov 8, 2007	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 12, 2004	Supplement 2Labeling · Standard review	Approved	Letter
Feb 13, 2003	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 21488
Drugs@FDA: Overview at FDA
Company: Tolmar, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters