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FDA NDA · NDA021732

VANTAS

Sponsor: ENDO OPERATIONS

APPLICATION
NDA021732
TYPE
NDA
ORIGINAL APPROVAL
2004-10-12
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
IMPLANT
MARKETING STATUS
Discontinued

Products

VANTAS · ReferenceDiscontinued
HISTRELIN ACETATE 50MG · IMPLANT · SUBCUTANEOUS

Approval history

2026-05-06Labeling · Supplement 26 · standard — Letter ↗AP
2025-09-23Labeling · Supplement 25 · standard — Letter ↗AP
2022-08-23Labeling · Supplement 24 · standard — Letter ↗AP
2020-12-16Labeling · Supplement 23 · standard — Letter ↗AP
2019-02-11Labeling · Supplement 22 · standard — Label ↗AP
2015-07-31Manufacturing (CMC) · Supplement 20 · standardAP
2014-07-08Labeling · Supplement 19 · standard — Letter ↗AP
2014-01-09Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP
2013-04-04Labeling · Supplement 18 · standard — Label ↗AP
2011-02-04Labeling · Supplement 7 · standard — Label ↗AP
2011-02-04Labeling · Supplement 12 · standard — Letter ↗AP
2011-02-04Labeling · Supplement 10 · unknown — Letter ↗AP
2011-01-14Labeling · Supplement 13 · 901 required — Label ↗AP
2008-09-25Manufacturing (CMC) · Supplement 5AP
2004-10-12Type 3 - New Dosage Form · Original · standard — Letter ↗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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