Intralipid 20%

Prevents EFAD. NDA 20248, held by Fresenius. Soybean Oil.

As of Nov 14, 2026, NDA 20248 (Intralipid 20%), held by Fresenius, was first approved by FDA on Aug 7, 1996, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 7, 1996
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Intralipid 20% Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of three-in-one or total nutrition admixtures (TNAs) to provide a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and a source of essential fatty acids for prevention of EFAD.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Aug 7, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Intralipid 20%20% · injectable;injection	Soybean Oil	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Jul 24, 2025	Supplement 31Labeling · Standard review	Approved	Label Letter
May 17, 2023	Supplement 28Labeling · Standard review	Approved	Label Letter
May 17, 2023	Supplement 27Labeling · Standard review	Approved	Label Letter
May 3, 2022	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 25, 2018	Supplement 22Labeling · Standard review	Approved	Letter
Dec 1, 2016	Supplement 20Labeling · Standard review	Approved	Letter Label
May 3, 2010	Supplement 16Labeling	Approved	None posted
May 13, 2005	Supplement 13Labeling	Approved	None posted
Aug 23, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 23, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 23, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 10, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 1, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 7, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20248
Drugs@FDA: Overview at FDA
Company: Fresenius

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