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FDA NDA · NDA214621

ORGOVYX

relugolix

Sponsor: SUMITOMO PHARMA AM

APPLICATION
NDA214621
TYPE
NDA
ORIGINAL APPROVAL
2020-12-18
LATEST ACTION
2025-10-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ORGOVYX · ReferencePrescription
RELUGOLIX 120MG · TABLET · ORAL

Approval history

2025-10-08Labeling · Supplement 12 · standard — Label ↗AP
2024-10-18Efficacy · Supplement 6 · standard — Letter ↗AP
2023-03-30Labeling · Supplement 4 · standard — Letter ↗AP
2020-12-18Type 1 - New Molecular Entity · Original · priority — Label ↗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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