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FDA NDA · NDA213388

ORIAHNN

elagolix and estradiol and norethisterone

Sponsor: ABBVIE

APPLICATION
NDA213388
TYPE
NDA
ORIGINAL APPROVAL
2020-05-29
LATEST ACTION
2025-12-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ORIAHNN (COPACKAGED) · ReferencePrescription
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE EQ 300MG BASE,1MG,0.5MG, ELAGOLIX SODIUM EQ 300MG BASE · CAPSULE · ORAL

Approval history

2025-12-17Labeling · Supplement 6 · standard — Letter ↗AP
2024-07-30Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2023-06-05Labeling · Supplement 3 · standard — Label ↗AP
2021-08-02Labeling · Supplement 1 · standard — Label ↗AP
2020-05-29Type 4 - New Combination · 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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