← FDA DRUG APPROVALS

FDA NDA · NDA021343

VABRINTY

leuprolide acetate

Sponsor: TOLMAR

APPLICATION
NDA021343
TYPE
NDA
ORIGINAL APPROVAL
2002-01-23
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ELIGARD KIT · ReferencePrescription
LEUPROLIDE ACETATE 7.5MG · POWDER · SUBCUTANEOUS

Approval history

2026-05-06Labeling · Supplement 60 · 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 47 · standard — Letter ↗AP
2023-07-20Efficacy · Supplement 48 · standard — Letter ↗AP
2019-02-15Labeling · Supplement 39 · standard — Label ↗AP
2017-01-13Manufacturing (CMC) · Supplement 34 · standardAP
2016-02-29Labeling · Supplement 33 · standard — Review ↗AP
2015-10-26Manufacturing (CMC) · Supplement 32 · standardAP
2014-10-10Labeling · Supplement 30 · standard — Label ↗AP
2014-10-10Manufacturing (CMC) · Supplement 31 · standardAP
2014-07-18Manufacturing (CMC) · Supplement 28 · standardAP
2014-05-30Manufacturing (CMC) · Supplement 29 · standardAP
2013-04-09Manufacturing (CMC) · Supplement 26 · standardAP
2013-02-27Labeling · Supplement 27 · standard — Letter ↗AP
2011-04-08Labeling · Supplement 20 · unknown — Label ↗AP
2011-01-14Labeling · Supplement 19 · 901 required — Label ↗AP
2010-10-05Labeling · Supplement 18 · unknown — Label ↗AP
2007-11-08Labeling · Supplement 15 · standard — Label ↗AP
2004-01-12Labeling · Supplement 4 · standard — Letter ↗AP
2003-07-03Labeling · Supplement 2 · standard — Letter ↗AP
2002-04-01Labeling · Supplement 1 · standard — Letter ↗AP
2002-01-23Type 3 - New Dosage Form · Original · standard — Label ↗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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