← FDA DRUG APPROVALS

FDA NDA · NDA020715

TRELSTAR

triptorelin pamoate

Sponsor: VERITY

APPLICATION
NDA020715
TYPE
NDA
ORIGINAL APPROVAL
2000-06-15
LATEST ACTION
2026-06-26
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TRELSTAR · ReferencePrescription
TRIPTORELIN PAMOATE EQ 3.75MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR

Approval history

2026-06-26Labeling · Supplement 52 · standard — Letter ↗AP
2025-09-23Labeling · Supplement 51 · standard — Letter ↗AP
2025-03-11Labeling · Supplement 50 · standard — Letter ↗AP
2024-04-12Labeling · Supplement 49 · standard — Label ↗AP
2023-11-17Labeling · Supplement 47 · standard — Letter ↗AP
2023-03-03Labeling · Supplement 45 · standard — Letter ↗AP
2018-12-14Labeling · Supplement 40 · standard — Label ↗AP
2015-02-03Manufacturing (CMC) · Supplement 34 · standardAP
2014-07-15Manufacturing (CMC) · Supplement 33 · standardAP
2014-07-11Labeling · Supplement 32 · standard — Label ↗AP
2014-03-14Manufacturing (CMC) · Supplement 31 · standardAP
2013-06-19Manufacturing (CMC) · Supplement 29 · standardAP
2013-04-25Manufacturing (CMC) · Supplement 27 · standardAP
2013-04-11Manufacturing (CMC) · Supplement 28 · standardAP
2013-03-12Labeling · Supplement 30 · standard — Label ↗AP
2011-05-19Labeling · Supplement 25 · unknown — Letter ↗AP
2011-01-14Labeling · Supplement 24 · 901 required — Letter ↗AP
2010-03-16Labeling · Supplement 18 · standardAP
2008-04-14Manufacturing (CMC) · Supplement 16 — Letter ↗AP
2007-02-16Manufacturing (CMC) · Supplement 13AP
2005-10-20Labeling · Supplement 6 · standard — Letter ↗AP
2002-01-15Labeling · Supplement 4 · standard — Letter ↗AP
2002-01-15Labeling · Supplement 3 · standard — Letter ↗AP
2001-06-20Manufacturing (CMC) · Supplement 2 · standardAP
2000-10-23Manufacturing (CMC) · Supplement 1 · standardAP
2000-06-15Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →