Trelstar

Treats advanced prostate cancer. NDA 20715, held by Verity. Triptorelin Pamoate.

As of Nov 13, 2026, NDA 20715 (Trelstar), held by Verity, was first approved by FDA on Jun 15, 2000, with 25 approved supplements and 0 published complete response letters.

First approved: Jun 15, 2000
Review: Standard
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRELSTAR 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 26 submissions below

Date	Submission	Status	Documents
Jun 15, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
TrelstarEQ 3.75MG BASE/VIAL · injectable;intramuscular	Triptorelin Pamoate	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Jun 26, 2026	Supplement 52Labeling · Standard review	Approved	Label Letter
Sep 23, 2025	Supplement 51Labeling · Standard review	Approved	Letter Label
Mar 11, 2025	Supplement 50Labeling · Standard review	Approved	Label Letter
Apr 12, 2024	Supplement 49Labeling · Standard review	Approved	Label Letter
Nov 17, 2023	Supplement 47Labeling · Standard review	Approved	Label Letter
Mar 3, 2023	Supplement 45Labeling · Standard review	Approved	Letter Label
Dec 14, 2018	Supplement 40Labeling · Standard review	Approved	Letter Label
Feb 3, 2015	Supplement 34Manufacturing · Standard review	Approved	None posted
Jul 15, 2014	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 11, 2014	Supplement 32Labeling · Standard review	Approved	Label Letter
Mar 14, 2014	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 19, 2013	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 25, 2013	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 11, 2013	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 12, 2013	Supplement 30Labeling · Standard review	Approved	Label Letter
May 19, 2011	Supplement 25Labeling	Approved	Letter Label
Jan 14, 2011	Supplement 24Labeling	Approved	Letter Label
Mar 16, 2010	Supplement 18Labeling · Standard review	Approved	None posted
Apr 14, 2008	Supplement 16Manufacturing	Approved	Letter
Feb 16, 2007	Supplement 13Manufacturing	Approved	None posted
Oct 20, 2005	Supplement 6Labeling · Standard review	Approved	Letter
Jan 15, 2002	Supplement 3Labeling · Standard review	Approved	Letter
Jan 15, 2002	Supplement 4Labeling · Standard review	Approved	Letter
Jun 20, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 23, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 15, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20715
Drugs@FDA: Overview at FDA
Company: Verity Pharmaceuticals

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