Clinolipid 20%

NDA 204508, held by Baxter Hlthcare Corp. Olive Oil; Soybean Oil.

As of Nov 14, 2026, NDA 204508 (Clinolipid 20%), held by Baxter Hlthcare Corp, was first approved by FDA on Oct 3, 2013, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2013
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CLINOLIPID is indicated in adults 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 12 submissions below


Apr 24, 2024	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 3, 2013	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clinolipid 20%16%(160GM/1000ML);4% (40GM/1000ML) · emulsion;intravenous	Olive Oil; Soybean Oil	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Jul 24, 2025	Supplement 26Labeling · Standard review	Approved	Label Label Letter
Apr 24, 2024	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 17, 2023	Supplement 21Labeling · Standard review	Approved	Label Letter
May 17, 2023	Supplement 19Labeling · Standard review	Approved	Label Letter
Apr 13, 2021	Supplement 15Labeling · Standard review	Approved	Label Letter
Jan 9, 2017	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 20, 2016	Supplement 5Labeling · Standard review	Approved	Letter Label
Feb 8, 2016	Supplement 4Manufacturing · Priority review	Approved	None posted
Nov 26, 2014	Supplement 3Manufacturing · Priority review	Approved	None posted
Aug 20, 2014	Supplement 2Manufacturing · Priority review	Approved	None posted
Jun 6, 2014	Supplement 1Manufacturing · Priority review	Approved	None posted
Oct 3, 2013	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 204508
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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