FDA — authorised 13 June 2017
- Application: ANDA207624
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Phosphate Binder Agents in United States
FDA authorised Phosphate Binder Agents on 13 June 2017
Marketing authorisations
FDA — authorised 17 July 2017
- Application: ANDA207179
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 2017
- Application: ANDA206094
- Marketing authorisation holder: DR REDDYS
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 October 2017
- Application: ANDA090975
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2017
- Application: ANDA203860
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2017
- Application: ANDA207288
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 2018
- Application: ANDA200959
- Marketing authorisation holder: ARTHUR GRP
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2018
- Application: ANDA210464
- Marketing authorisation holder: DR REDDYS
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 November 2018
- Application: ANDA204451
- Marketing authorisation holder: RISING
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 April 2020
- Application: ANDA212970
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 2020
- Application: ANDA201069
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2020
- Application: ANDA211316
- Marketing authorisation holder: IMPAX
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 January 2021
- Application: ANDA204600
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2021
- Application: ANDA209374
- Marketing authorisation holder: BIONPHARMA
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 December 2021
- Application: ANDA201513
- Marketing authorisation holder: LUPIN
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 March 2023
- Application: ANDA217319
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 April 2023
- Application: ANDA206100
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2023
- Application: ANDA211917
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 April 2024
- Application: ANDA207291
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 May 2024
- Application: ANDA211915
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2024
- Application: ANDA206234
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 October 2024
- Application: ANDA215998
- Marketing authorisation holder: SHANDONG XINHUA
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2025
- Application: ANDA219931
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 2026
- Application: ANDA212563
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: FERRIC CITRATE
- Indication: TABLET — ORAL
- Status: approved
Phosphate Binder Agents in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Phosphate Binder Agents approved in United States?
Yes. FDA authorised it on 13 June 2017; FDA authorised it on 17 July 2017; FDA authorised it on 29 September 2017.
Who is the marketing authorisation holder for Phosphate Binder Agents in United States?
AUROBINDO PHARMA holds the US marketing authorisation.