FDA — authorised 28 February 1984
- Application: NDA018494
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Potassium Chloride in United States
FDA authorised Potassium Chloride on 28 February 1984
Marketing authorisations
FDA — authorised 24 March 2022
- Application: ANDA214108
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
FDA — authorised 29 June 2022
- Application: ANDA215370
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 8 May 2025
- Application: NDA219616
- Marketing authorisation holder: VERASTEM INC
- Indication: Type 1 - New Molecular Entity
- Status: approved
The FDA approved Potassium Chloride, a new molecular entity, for marketing by VERASTEM INC on 2025-05-08. The approval was granted under the standard expedited pathway. The local brand name for the drug is not reported.
FDA — authorised 27 October 2025
- Application: ANDA218979
- Marketing authorisation holder: TWI PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Potassium Chloride for marketing by TWI PHARMS on 27 October 2025. The approval was granted under the standard expedited pathway. The indication approved is for labeling, which typically involves the approval of the product's labelling and packaging.
FDA
- Marketing authorisation holder: TORRENT
- Status: approved
Potassium Chloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Potassium Chloride approved in United States?
Yes. FDA authorised it on 28 February 1984; FDA authorised it on 24 March 2022; FDA authorised it on 29 June 2022.
Who is the marketing authorisation holder for Potassium Chloride in United States?
BAXTER HLTHCARE holds the US marketing authorisation.