Eligard Kit

Treats advanced prostate cancer. NDA 21343, held by Tolmar. Leuprolide Acetate.

As of Nov 14, 2026, NDA 21343 (Eligard Kit), held by Tolmar, was first approved by FDA on Jan 23, 2002, with 24 approved supplements and 0 published complete response letters.

First approved: Jan 23, 2002
Review: Standard
Supplements approved: 24
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 25 submissions below


Jul 20, 2023	Supplement 48Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 20, 2023	Supplement 47Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 23, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eligard Kit7.5MG · powder;subcutaneous	Leuprolide Acetate	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


May 6, 2026	Supplement 60Labeling · Standard review	Approved	Label Letter
Feb 24, 2025	Supplement 56Labeling · Standard review	Approved	Label Letter
Feb 4, 2025	Supplement 55Labeling · Standard review	Approved	Letter Label
May 21, 2024	Supplement 52Labeling · Standard review	Approved	Letter Label
Jan 23, 2024	Supplement 51Labeling · Standard review	Approved	Label Letter
Jul 20, 2023	Supplement 48Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 20, 2023	Supplement 47Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 15, 2019	Supplement 39Labeling · Standard review	Approved	Letter Label
Jan 13, 2017	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 29, 2016	Supplement 33Labeling · Standard review	Approved	Label Letter Review
Oct 26, 2015	Supplement 32Manufacturing · Standard review	Approved	None posted
Oct 10, 2014	Supplement 31Manufacturing · Standard review	Approved	None posted
Oct 10, 2014	Supplement 30Labeling · Standard review	Approved	Label Letter
Jul 18, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
May 30, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 9, 2013	Supplement 26Manufacturing · Standard review	Approved	None posted
Feb 27, 2013	Supplement 27Labeling · Standard review	Approved	Letter Label
Apr 8, 2011	Supplement 20Labeling	Approved	Letter Label
Jan 14, 2011	Supplement 19Labeling	Approved	Label Letter
Oct 5, 2010	Supplement 18Labeling	Approved	Letter Label
Nov 8, 2007	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 12, 2004	Supplement 4Labeling · Standard review	Approved	Letter
Jul 3, 2003	Supplement 2Labeling · Standard review	Approved	Letter
Apr 1, 2002	Supplement 1Labeling · Standard review	Approved	Letter
Jan 23, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21343
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