FDA — authorised 7 December 2000
- Application: NDA019873
- Marketing authorisation holder: B BRAUN
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Potassium Phosphates in United States
FDA authorised Potassium Phosphates on 7 December 2000
Marketing authorisations
FDA — authorised 19 September 2019
- Application: NDA212121
- Marketing authorisation holder: CMP DEV LLC
- Local brand name: POTASSIUM PHOSPHATES
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 November 2019
- Application: NDA212832
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POTASSIUM PHOSPHATES
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA approved Potassium Phosphates for manufacturing (CMC) purposes on 30 August 2024. This approval was granted to FRESENIUS KABI USA, the marketing authorisation holder. The approval was made through the standard expedited pathway.
FDA — authorised 2 October 2023
- Application: ANDA216274
- Marketing authorisation holder: AM REGENT
- Local brand name: POTASSIUM PHOSPHATES
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA approved the marketing authorisation for Potassium Phosphates, submitted by AM REGENT, on 30 January 2025. The approval was granted for manufacturing (CMC) purposes, which involves the production and quality control of the drug substance. This approval allows AM REGENT to manufacture Potassium Phosphates for use in pharmaceutical products.
FDA — authorised 10 October 2023
- Application: ANDA216344
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 11 July 2024
- Application: ANDA217726
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: POTASSIUM PHOSPHATES
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 24 January 2025
- Application: ANDA217892
- Marketing authorisation holder: CIPLA
- Local brand name: POTASSIUM PHOSPHATES
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 11 September 2025
- Application: ANDA217459
- Marketing authorisation holder: HOSPIRA
- Local brand name: POTASSIUM PHOSPHATES
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 12 March 2026
- Application: ANDA220373
- Marketing authorisation holder: CAPLIN
- Local brand name: POTASSIUM PHOSPHATES
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Pricing & reimbursement
- annual_list: USD 118.35 per year
Potassium Phosphates in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Potassium Phosphates approved in United States?
Yes. FDA authorised it on 7 December 2000; FDA authorised it on 19 September 2019; FDA authorised it on 26 November 2019.
Who is the marketing authorisation holder for Potassium Phosphates in United States?
B BRAUN holds the US marketing authorisation.
What does Potassium Phosphates cost in United States?
annual_list: USD 118.35 per year. Final patient cost depends on reimbursement and any patient access scheme.