FDA — authorised 30 April 2013
- Application: NDA203389
- Marketing authorisation holder: HORIZON
- Local brand name: PROCYSBI
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Cysteamine Bitartrate Delayed-release Capsules in United States
FDA authorised Cysteamine Bitartrate Delayed-release Capsules on 30 April 2013
Marketing authorisations
FDA — authorised 14 February 2020
- Application: NDA213491
- Marketing authorisation holder: HORIZON
- Local brand name: PROCYSBI
- Indication: GRANULE, DELAYED RELEASE — ORAL
- Status: approved
Frequently asked questions
Is Cysteamine Bitartrate Delayed-release Capsules approved in United States?
Yes. FDA authorised it on 30 April 2013; FDA authorised it on 14 February 2020.
Who is the marketing authorisation holder for Cysteamine Bitartrate Delayed-release Capsules in United States?
HORIZON holds the US marketing authorisation.