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FABHALTA

NDA · New Drug Application · Sponsor: NOVARTIS · Approved 2023-12-05

Drug application

FDA Application #

NDA218276

Application type

New Drug Application

Brand name

FABHALTA

Generic name

IPTACOPAN

Active ingredients

IPTACOPAN HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

NOVARTIS

Manufacturer

Novartis Pharmaceuticals Corporation

First approval

2023-12-05

Source

Authoritative

Drugs@FDA application overview

Machine

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