← FDA DRUG APPROVALS

FDA NDA · NDA021731

VABRINTY

leuprolide acetate

Sponsor: TOLMAR

APPLICATION
NDA021731
TYPE
NDA
ORIGINAL APPROVAL
2004-12-14
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ELIGARD KIT · ReferencePrescription
LEUPROLIDE ACETATE 45MG · POWDER · SUBCUTANEOUS

Approval history

2026-05-06Labeling · Supplement 62 · standard — Letter ↗AP
2025-02-24Labeling · Supplement 56 · standard — Label ↗AP
2025-02-04Labeling · Supplement 55 · standard — Letter ↗AP
2024-05-21Labeling · Supplement 52 · standard — Letter ↗AP
2024-01-23Labeling · Supplement 51 · standard — Letter ↗AP
2023-07-20Efficacy · Supplement 44 · standard — Letter ↗AP
2023-07-20Efficacy · Supplement 47 · standard — Letter ↗AP
2022-11-25Manufacturing (CMC) · Supplement 43 · standardAP
2019-02-15Labeling · Supplement 37 · standard — Label ↗AP
2016-02-29Labeling · Supplement 29 · standard — Label ↗AP
2014-10-10Labeling · Supplement 27 · standard — Label ↗AP
2014-07-18Manufacturing (CMC) · Supplement 24 · standardAP
2013-04-03Manufacturing (CMC) · Supplement 22 · standardAP
2013-02-27Labeling · Supplement 23 · standard — Label ↗AP
2011-04-08Labeling · Supplement 13 · unknown — Letter ↗AP
2011-01-14Labeling · Supplement 12 · 901 required — Letter ↗AP
2010-10-05Labeling · Supplement 10 · unknown — Letter ↗AP
2007-11-08Labeling · Supplement 5 · standard — Letter ↗AP
2006-09-29Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2004-12-14Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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