Smoflipid 20%

NDA 207648, held by Fresenius Kabi USA. Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil.

As of Nov 14, 2026, NDA 207648 (Smoflipid 20%), held by Fresenius Kabi USA, was first approved by FDA on Jul 13, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 13, 2016
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


Mar 22, 2022	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 13, 2016	Original applicationNew combination · Standard review	Approved	Review Label Letter

Products

4 strengths and forms


Smoflipid 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) · emulsion;intravenous	Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil	RxReference drug
Smoflipid 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) · emulsion;intravenous	Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil	RxReference drug
Smoflipid 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) · emulsion;intravenous	Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil	RxReference drug
Smoflipid 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) · emulsion;intravenous	Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Jul 24, 2025	Supplement 13Labeling · Standard review	Approved	Label Letter
May 17, 2023	Supplement 10Labeling · Standard review	Approved	Label Letter
Mar 22, 2022	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 8, 2020	Supplement 3Labeling · Standard review	Approved	Label Letter
Jul 13, 2016	Original applicationNew combination · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 207648
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters