🇺🇸 lipid emulsion for TPN in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised lipid emulsion for TPN on 13 July 2016

Marketing authorisation

FDA — authorised 13 July 2016

Application: NDA207648
Marketing authorisation holder: FRESENIUS KABI USA
Local brand name: SMOFLIPID 20%
Indication: EMULSION — INTRAVENOUS
Status: approved

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Frequently asked questions

Is lipid emulsion for TPN approved in United States?

Yes. FDA authorised it on 13 July 2016.

Who is the marketing authorisation holder for lipid emulsion for TPN in United States?

FRESENIUS KABI USA holds the US marketing authorisation.