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ORILISSA

NDA · New Drug Application · Sponsor: ABBVIE · Approved 2018-07-23

Drug application

FDA Application #

NDA210450

Application type

New Drug Application

Brand name

ORILISSA

Generic name

ELAGOLIX

Active ingredients

ELAGOLIX SODIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ABBVIE

Manufacturer

AbbVie Inc.

First approval

2018-07-23

Source

Authoritative

Drugs@FDA application overview

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