FDA — authorised 20 July 1984
- Application: NDA018896
- Marketing authorisation holder: HOSPIRA
- Local brand name: POTASSIUM ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Potassium Acetate in United States
FDA authorised Potassium Acetate on 20 July 1984
Marketing authorisations
FDA — authorised 30 August 1991
- Application: NDA017610
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 25 October 2017
- Application: ANDA206203
- Marketing authorisation holder: EXELA PHARMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 November 2024
- Application: ANDA217515
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POTASSIUM ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Potassium Acetate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Potassium Acetate approved in United States?
Yes. FDA authorised it on 20 July 1984; FDA authorised it on 30 August 1991; FDA authorised it on 25 October 2017.
Who is the marketing authorisation holder for Potassium Acetate in United States?
HOSPIRA holds the US marketing authorisation.