← FDA DRUG APPROVALS

FDA NDA · NDA022437

TRELSTAR

triptorelin pamoate

Sponsor: VERITY

APPLICATION
NDA022437
TYPE
NDA
ORIGINAL APPROVAL
2010-03-10
LATEST ACTION
2026-06-26
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TRELSTAR · ReferencePrescription
TRIPTORELIN PAMOATE EQ 22.5MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR

Approval history

2026-06-26Labeling · Supplement 27 · standard — Letter ↗AP
2025-09-23Labeling · Supplement 26 · standard — Letter ↗AP
2025-03-11Labeling · Supplement 25 · standard — Letter ↗AP
2024-04-12Labeling · Supplement 24 · standard — Label ↗AP
2023-11-17Labeling · Supplement 22 · standard — Letter ↗AP
2023-03-03Labeling · Supplement 20 · standard — Letter ↗AP
2018-12-14Labeling · Supplement 15 · standard — Label ↗AP
2015-01-26Manufacturing (CMC) · Supplement 11 · standardAP
2015-01-20Manufacturing (CMC) · Supplement 10 · standardAP
2014-07-11Labeling · Supplement 8 · standard — Letter ↗AP
2014-07-03Manufacturing (CMC) · Supplement 9 · standardAP
2013-04-25Manufacturing (CMC) · Supplement 4 · standardAP
2013-04-19Manufacturing (CMC) · Supplement 6 · standardAP
2013-04-11Manufacturing (CMC) · Supplement 5 · standardAP
2013-03-12Labeling · Supplement 7 · standard — Label ↗AP
2011-05-19Labeling · Supplement 3 · unknown — Label ↗AP
2011-01-14Labeling · Supplement 2 · 901 required — Label ↗AP
2010-03-10Type 3 - New Dosage Form · Original · standard — Review ↗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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