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CTEXLI

NDA · New Drug Application · Sponsor: MIRUM · Approved 2025-02-21

Drug application

FDA Application #

NDA219488

Application type

New Drug Application

Brand name

CTEXLI

Generic name

CHENODIOL

Active ingredients

CHENODIOL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

MIRUM

Manufacturer

Mirum Pharmaceuticals Inc.

First approval

2025-02-21

Source

Authoritative

Drugs@FDA application overview

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