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PROCYSBI

NDA · New Drug Application · Sponsor: HORIZON · Approved 2020-02-14

Drug application

FDA Application #

NDA213491

Application type

New Drug Application

Brand name

PROCYSBI

Generic name

CYSTEAMINE BITARTRATE

Active ingredients

CYSTEAMINE BITARTRATE

Dosage form

GRANULE, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

HORIZON

Manufacturer

Horizon Therapeutics USA, Inc.

First approval

2020-02-14

Source

Authoritative

Drugs@FDA application overview

Machine

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