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Approved Drug Products containing Elagolix listed in the FDA Orange Book. Original Data : FDA Website

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Discovery on Target
Not Confirmed

ELAGOLIX SODIUM

Brand Name : ORILISSA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2018-07-23

Application Number : 210450

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Discovery on Target
Not Confirmed

ELAGOLIX SODIUM

Brand Name : ORILISSA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2018-07-23

Application Number : 210450

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

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Discovery on Target
Not Confirmed

ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

Brand Name : ORIAHNN (COPACKAGED)

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE

Approval Date : 2020-05-29

Application Number : 213388

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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