← FDA DRUG APPROVALS

FDA NDA · NDA021379

VABRINTY

leuprolide acetate

Sponsor: TOLMAR

APPLICATION
NDA021379
TYPE
NDA
ORIGINAL APPROVAL
2002-07-24
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ELIGARD KIT · ReferencePrescription
LEUPROLIDE ACETATE 22.5MG · POWDER · SUBCUTANEOUS

Approval history

2026-05-06Labeling · Supplement 65 · standard — Letter ↗AP
2025-02-24Labeling · Supplement 59 · standard — Label ↗AP
2025-02-04Labeling · Supplement 58 · standard — Letter ↗AP
2024-05-21Labeling · Supplement 55 · standard — Label ↗AP
2024-01-23Labeling · Supplement 53 · standard — Letter ↗AP
2023-07-20Efficacy · Supplement 50 · standard — Letter ↗AP
2023-07-20Efficacy · Supplement 49 · standard — Letter ↗AP
2019-02-15Labeling · Supplement 41 · standard — Label ↗AP
2016-02-29Labeling · Supplement 33 · standard — Label ↗AP
2014-10-10Labeling · Supplement 30 · standard — Letter ↗AP
2014-07-18Manufacturing (CMC) · Supplement 26 · standardAP
2014-04-15Manufacturing (CMC) · Supplement 28 · standardAP
2014-02-03Manufacturing (CMC) · Supplement 27 · standardAP
2013-02-27Labeling · Supplement 25 · standard — Letter ↗AP
2013-02-08Manufacturing (CMC) · Supplement 23 · standardAP
2013-01-25Manufacturing (CMC) · Supplement 22 · standardAP
2011-04-08Labeling · Supplement 16 · unknown — Letter ↗AP
2011-01-14Labeling · Supplement 15 · 901 required — Letter ↗AP
2010-10-05Labeling · Supplement 14 · unknown — Letter ↗AP
2007-11-08Labeling · Supplement 10 · standard — Label ↗AP
2004-01-12Labeling · Supplement 2 · standard — Review ↗AP
2002-07-24Type 3 - New Dosage Form · 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 →