← FDA Drug Approvals (Drugs@FDA)

PROCYSBI

NDA · New Drug Application · Sponsor: HORIZON · Approved 2013-04-30

Drug application

FDA Application #

NDA203389

Application type

New Drug Application

Brand name

PROCYSBI

Generic name

CYSTEAMINE BITARTRATE

Active ingredients

CYSTEAMINE BITARTRATE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

HORIZON

Manufacturer

Horizon Therapeutics USA, Inc.

First approval

2013-04-30

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown