Eligard Kit

Treats advanced prostate cancer. NDA 21731, held by Tolmar. Leuprolide Acetate.

As of Nov 14, 2026, NDA 21731 (Eligard Kit), held by Tolmar, was first approved by FDA on Dec 14, 2004, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 14, 2004
Review: Standard
Supplements approved: 19
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 20 submissions below


Jul 20, 2023	Supplement 47Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 20, 2023	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 14, 2004	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eligard Kit45MG · powder;subcutaneous	Leuprolide Acetate	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


May 6, 2026	Supplement 62Labeling · 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 47Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 20, 2023	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 25, 2022	Supplement 43Manufacturing · Standard review	Approved	None posted
Feb 15, 2019	Supplement 37Labeling · Standard review	Approved	Letter Label
Feb 29, 2016	Supplement 29Labeling · Standard review	Approved	Label Letter
Oct 10, 2014	Supplement 27Labeling · Standard review	Approved	Label Letter
Jul 18, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 3, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 27, 2013	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 8, 2011	Supplement 13Labeling	Approved	Letter Label
Jan 14, 2011	Supplement 12Labeling	Approved	Letter Label
Oct 5, 2010	Supplement 10Labeling	Approved	Letter Label
Nov 8, 2007	Supplement 5Labeling · Standard review	Approved	Letter Label
Sep 29, 2006	Supplement 4Manufacturing	Approved	Letter
Dec 14, 2004	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 21731
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