Eligard Kit

Treats advanced prostate cancer. NDA 21379, held by Tolmar. Leuprolide Acetate.

As of Nov 14, 2026, NDA 21379 (Eligard Kit), held by Tolmar, was first approved by FDA on Jul 24, 2002, with 21 approved supplements and 0 published complete response letters.

First approved: Jul 24, 2002
Review: Standard
Supplements approved: 21
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 22 submissions below


Jul 20, 2023	Supplement 50Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 20, 2023	Supplement 49Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 24, 2002	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eligard Kit22.5MG · powder;subcutaneous	Leuprolide Acetate	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


May 6, 2026	Supplement 65Labeling · Standard review	Approved	Label Letter
Feb 24, 2025	Supplement 59Labeling · Standard review	Approved	Label Letter
Feb 4, 2025	Supplement 58Labeling · Standard review	Approved	Letter Label
May 21, 2024	Supplement 55Labeling · Standard review	Approved	Label Letter
Jan 23, 2024	Supplement 53Labeling · Standard review	Approved	Label Letter
Jul 20, 2023	Supplement 50Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 20, 2023	Supplement 49Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 15, 2019	Supplement 41Labeling · Standard review	Approved	Letter Label
Feb 29, 2016	Supplement 33Labeling · Standard review	Approved	Label Letter
Oct 10, 2014	Supplement 30Labeling · Standard review	Approved	Label Letter
Jul 18, 2014	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 15, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 3, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 27, 2013	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 8, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 25, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 8, 2011	Supplement 16Labeling	Approved	Letter Label
Jan 14, 2011	Supplement 15Labeling	Approved	Letter Label
Oct 5, 2010	Supplement 14Labeling	Approved	Letter Label
Nov 8, 2007	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 12, 2004	Supplement 2Labeling · Standard review	Approved	Review Letter
Jul 24, 2002	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 21379
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