Trelstar

Treats advanced prostate cancer. NDA 21288, held by Verity. Triptorelin Pamoate.

As of Nov 14, 2026, NDA 21288 (Trelstar), held by Verity, was first approved by FDA on Jun 29, 2001, with 17 approved supplements and 0 published complete response letters.

First approved: Jun 29, 2001
Review: Standard
Supplements approved: 17
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 18 submissions below

Date	Submission	Status	Documents
Jun 29, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
TrelstarEQ 11.25MG BASE/VIAL · injectable;intramuscular	Triptorelin Pamoate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Jun 26, 2026	Supplement 47Labeling · Standard review	Approved	Label Letter
Sep 23, 2025	Supplement 46Labeling · Standard review	Approved	Letter Label
Mar 11, 2025	Supplement 45Labeling · Standard review	Approved	Label Letter
Apr 12, 2024	Supplement 44Labeling · Standard review	Approved	Label Letter
Nov 17, 2023	Supplement 42Labeling · Standard review	Approved	Label Letter
Mar 3, 2023	Supplement 40Labeling · Standard review	Approved	Letter Label
Dec 14, 2018	Supplement 35Labeling · Standard review	Approved	Letter Label
Jul 15, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 11, 2014	Supplement 28Labeling · Standard review	Approved	Label Letter
Apr 25, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 12, 2013	Supplement 27Labeling · Standard review	Approved	Letter Label
May 19, 2011	Supplement 22Labeling	Approved	Letter Label
Jan 14, 2011	Supplement 21Labeling	Approved	Letter Label
Mar 17, 2010	Supplement 15Labeling · Standard review	Approved	None posted
Apr 14, 2008	Supplement 13Manufacturing	Approved	Letter
Feb 16, 2007	Supplement 9Manufacturing	Approved	None posted
Oct 20, 2005	Supplement 2Labeling · Standard review	Approved	Letter
Jun 29, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21288
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