# PROCYSBI
> **NDA203389** · New Drug Application · Sponsor: HORIZON · Approved 2013-04-30
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203389)
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