FDA — authorised 5 June 1958
- Marketing authorisation holder: CONCORDIA PHARMS INC
- Status: approved
🇺🇸 Sps in United States
FDA authorised Sps on 5 June 1958
Marketing authorisations
FDA — authorised 8 December 1982
- Application: ANDA087859
- Marketing authorisation holder: CMP PHARMA INC
- Local brand name: SPS
- Indication: SUSPENSION — ORAL, RECTAL
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA089049
- Marketing authorisation holder: HIKMA
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: SUSPENSION — ORAL, RECTAL
- Status: approved
FDA — authorised 19 January 1989
- Application: ANDA089910
- Marketing authorisation holder: CMP PHARMA INC
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 6 February 1998
- Application: ANDA040029
- Marketing authorisation holder: ANI PHARMS
- Local brand name: KIONEX
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 17 September 2007
- Application: ANDA040028
- Marketing authorisation holder: ANI PHARMS
- Local brand name: KIONEX
- Indication: SUSPENSION — ORAL, RECTAL
- Status: approved
The FDA approved Sps for manufacturing (CMC) on 2024-05-03. This approval was granted to ANI PHARMS under application number ANDA040028. The approval was processed through the standard expedited pathway.
FDA — authorised 3 December 2008
- Application: ANDA040909
- Marketing authorisation holder: CITRUSPHRMA
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 30 March 2009
- Application: ANDA040905
- Marketing authorisation holder: KVK TECH
- Local brand name: KALEXATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 13 May 2011
- Application: ANDA090590
- Marketing authorisation holder: ANI PHARMS
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: SUSPENSION — ORAL, RECTAL
- Status: approved
FDA — authorised 21 December 2011
- Application: ANDA090313
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 19 March 2014
- Application: ANDA202333
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 28 November 2014
- Application: ANDA204071
- Marketing authorisation holder: NUVO PHARMS INC
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 18 February 2016
- Application: ANDA206815
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 23 February 2016
- Application: ANDA205727
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA — authorised 10 June 2025
- Application: ANDA214912
- Marketing authorisation holder: LYNE
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: SUSPENSION — ORAL, RECTAL
- Status: approved
FDA
- Application: ANDA088453
- Marketing authorisation holder: ROXANE
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: SUSPENSION — ORAL, RECTAL
- Status: approved
FDA
- Application: ANDA088717
- Marketing authorisation holder: MORTON GROVE
- Local brand name: SODIUM POLYSTYRENE SULFONATE
- Indication: SUSPENSION — ORAL, RECTAL
- Status: approved
Sps in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Sps approved in United States?
Yes. FDA authorised it on 5 June 1958; FDA authorised it on 8 December 1982; FDA authorised it on 17 November 1986.
Who is the marketing authorisation holder for Sps in United States?
CONCORDIA PHARMS INC holds the US marketing authorisation.