← FDA DRUG APPROVALS

FDA NDA · NDA022058

SUPPRELIN LA

histrelin acetate

Sponsor: ENDO OPERATIONS

APPLICATION
NDA022058
TYPE
NDA
ORIGINAL APPROVAL
2007-05-03
LATEST ACTION
2025-09-23
ROUTE
SUBCUTANEOUS
DOSAGE FORM
IMPLANT
MARKETING STATUS
Prescription

Products

SUPPRELIN LA · ReferencePrescription
HISTRELIN ACETATE 50MG · IMPLANT · SUBCUTANEOUS

Approval history

2025-09-23Labeling · Supplement 20 · standard — Letter ↗AP
2022-04-22Labeling · Supplement 17 · standard — Letter ↗AP
2019-11-08Labeling · Supplement 16 · standard — Label ↗AP
2017-05-19Labeling · Supplement 14 · standard — Label ↗AP
2017-05-19Labeling · Supplement 15 · standard — Label ↗AP
2015-04-21Manufacturing (CMC) · Supplement 12 · standardAP
2013-06-19Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP
2013-04-02Labeling · Supplement 11 · standard — Letter ↗AP
2012-04-05Labeling · Supplement 9 · standard — Letter ↗AP
2011-10-30Labeling · Supplement 6 · standard — Label ↗AP
2008-07-02Manufacturing (CMC) · Supplement 3 — Label ↗AP
2007-11-21Labeling · Supplement 1 · standard — Letter ↗AP
2007-05-03Type 5 - New Formulation or New Manufacturer · 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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