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

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01

Luxepack
Not Confirmed
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ODEVIXIBAT

Brand Name : BYLVAY

Dosage Form : CAPSULE, PELLETS;ORAL

Dosage Strength : 0.2MG

Approval Date : 2021-07-20

Application Number : 215498

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ODEVIXIBAT

Brand Name : BYLVAY

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.4MG

Approval Date : 2021-07-20

Application Number : 215498

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ODEVIXIBAT

Brand Name : BYLVAY

Dosage Form : CAPSULE, PELLETS;ORAL

Dosage Strength : 0.6MG

Approval Date : 2021-07-20

Application Number : 215498

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ODEVIXIBAT

Brand Name : BYLVAY

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1.2MG

Approval Date : 2021-07-20

Application Number : 215498

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank