← FDA DRUG APPROVALS

FDA NDA · NDA021288

TRELSTAR

triptorelin pamoate

Sponsor: VERITY

APPLICATION
NDA021288
TYPE
NDA
ORIGINAL APPROVAL
2001-06-29
LATEST ACTION
2026-06-26
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TRELSTAR · ReferencePrescription
TRIPTORELIN PAMOATE EQ 11.25MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR

Approval history

2026-06-26Labeling · Supplement 47 · standard — Letter ↗AP
2025-09-23Labeling · Supplement 46 · standard — Letter ↗AP
2025-03-11Labeling · Supplement 45 · standard — Letter ↗AP
2024-04-12Labeling · Supplement 44 · standard — Label ↗AP
2023-11-17Labeling · Supplement 42 · standard — Letter ↗AP
2023-03-03Labeling · Supplement 40 · standard — Letter ↗AP
2018-12-14Labeling · Supplement 35 · standard — Label ↗AP
2014-07-15Manufacturing (CMC) · Supplement 29 · standardAP
2014-07-11Labeling · Supplement 28 · standard — Label ↗AP
2013-04-25Manufacturing (CMC) · Supplement 24 · standardAP
2013-03-12Labeling · Supplement 27 · standard — Letter ↗AP
2011-05-19Labeling · Supplement 22 · unknown — Letter ↗AP
2011-01-14Labeling · Supplement 21 · 901 required — Letter ↗AP
2010-03-17Labeling · Supplement 15 · standardAP
2008-04-14Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2007-02-16Manufacturing (CMC) · Supplement 9AP
2005-10-20Labeling · Supplement 2 · standard — Letter ↗AP
2001-06-29Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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