← FDA DRUG APPROVALS

FDA NDA · NDA021488

VABRINTY

leuprolide acetate

Sponsor: TOLMAR

APPLICATION
NDA021488
TYPE
NDA
ORIGINAL APPROVAL
2003-02-13
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ELIGARD KIT · ReferencePrescription
LEUPROLIDE ACETATE 30MG · POWDER · SUBCUTANEOUS

Approval history

2026-05-06Labeling · Supplement 57 · standard — Letter ↗AP
2025-02-24Labeling · Supplement 53 · standard — Label ↗AP
2025-02-04Labeling · Supplement 52 · standard — Letter ↗AP
2024-05-21Labeling · Supplement 50 · standard — Label ↗AP
2024-01-23Labeling · Supplement 48 · standard — Letter ↗AP
2023-07-20Efficacy · Supplement 44 · standard — Letter ↗AP
2023-07-20Efficacy · Supplement 45 · standard — Letter ↗AP
2019-02-15Labeling · Supplement 36 · standard — Label ↗AP
2016-02-29Labeling · Supplement 30 · standard — Label ↗AP
2014-10-10Labeling · Supplement 27 · standard — Letter ↗AP
2013-02-27Labeling · Supplement 25 · standard — Label ↗AP
2011-04-08Labeling · Supplement 17 · unknown — Label ↗AP
2011-01-14Labeling · Supplement 16 · 901 required — Label ↗AP
2010-10-05Labeling · Supplement 15 · unknown — Label ↗AP
2007-11-08Labeling · Supplement 10 · standard — Label ↗AP
2004-01-12Labeling · Supplement 2 · standard — Letter ↗AP
2003-02-13Type 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 →