FDA — authorised 8 December 1982
- Application: ANDA087859
- Marketing authorisation holder: CMP PHARMA INC
- Status: supplemented
🇺🇸 polystyrene sulfonate in United States
FDA authorised polystyrene sulfonate on 8 December 1982
Marketing authorisations
FDA — authorised 19 January 1989
- Application: ANDA089910
- Marketing authorisation holder: CMP PHARMA INC
- Status: supplemented
FDA — authorised 30 March 2009
- Application: ANDA040905
- Marketing authorisation holder: KVK TECH
- Status: supplemented
FDA — authorised 19 March 2014
- Application: ANDA202333
- Marketing authorisation holder: EPIC PHARMA LLC
- Status: supplemented
FDA — authorised 18 February 2016
- Application: ANDA206815
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
Frequently asked questions
Is polystyrene sulfonate approved in United States?
Yes. FDA authorised it on 8 December 1982; FDA authorised it on 19 January 1989; FDA authorised it on 30 March 2009.
Who is the marketing authorisation holder for polystyrene sulfonate in United States?
CMP PHARMA INC holds the US marketing authorisation.