FDA — authorised 2 February 1979
- Application: NDA017378
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: PLASMA-LYTE A IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Plasma-Lyte A In Plastic Container in United States
FDA authorised Plasma-Lyte A In Plastic Container on 2 February 1979
Marketing authorisations
FDA — authorised 4 May 1983
- Application: NDA018893
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 30 October 2017
- Application: ANDA206687
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 May 2021
- Application: ANDA214805
- Marketing authorisation holder: MILLA PHARMS
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 March 2024
- Application: ANDA216920
- Marketing authorisation holder: HIKMA
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 17 April 2026
- Application: ANDA220274
- Marketing authorisation holder: EXTROVIS
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA approved Plasma-Lyte A In Plastic Container for intravenous use on 2026-04-17. This approval was granted to EXTROVIS under the standard expedited pathway. Plasma-Lyte A In Plastic Container is a solution containing sodium acetate, intended for intravenous administration.
FDA
- Status: approved
Plasma-Lyte A In Plastic Container 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 Plasma-Lyte A In Plastic Container approved in United States?
Yes. FDA authorised it on 2 February 1979; FDA authorised it on 4 May 1983; FDA authorised it on 30 October 2017.
Who is the marketing authorisation holder for Plasma-Lyte A In Plastic Container in United States?
BAXTER HLTHCARE holds the US marketing authorisation.