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FDA NDA · NDA210450

ORILISSA

elagolix

Sponsor: ABBVIE

APPLICATION
NDA210450
TYPE
NDA
ORIGINAL APPROVAL
2018-07-23
LATEST ACTION
2025-12-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ORILISSA · ReferencePrescription
ELAGOLIX SODIUM EQ 150MG BASE · TABLET · ORAL
ORILISSA · ReferencePrescription
ELAGOLIX SODIUM EQ 200MG BASE · TABLET · ORAL

Approval history

2025-12-17Labeling · Supplement 11 · standard — Letter ↗AP
2023-06-05Labeling · Supplement 9 · standard — Label ↗AP
2021-02-01Efficacy · Supplement 6 · standard — Letter ↗AP
2021-02-01Efficacy · Supplement 4 · standard — Letter ↗AP
2021-02-01Efficacy · Supplement 5 · standard — Letter ↗AP
2019-08-28Labeling · Supplement 2 · standard — Label ↗AP
2018-07-23Type 1 - New Molecular Entity · Original · priority — Letter ↗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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