Lipiodol

Used in scans for known hepatocellular carcinoma (HCC). NDA 9190, held by Guerbet. Ethiodized Oil.

As of Nov 13, 2026, NDA 9190 (Lipiodol), held by Guerbet, was first approved by FDA on Mar 31, 1954, with 11 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1954
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Apr 4, 2014	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 31, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
LipiodolEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML) · oil;intralymphatic, intrauterine	Ethiodized Oil	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Apr 5, 2023	Supplement 32Labeling · Standard review	Approved	Label Letter
Jun 10, 2020	Supplement 29Labeling · Standard review	Approved	Letter Label
Jun 10, 2020	Supplement 31Labeling · Standard review	Approved	Letter Label
Sep 28, 2018	Supplement 27Manufacturing	Approved	None posted
Apr 4, 2014	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 21, 2014	Supplement 21Labeling · Standard review	Approved	Label Letter
Jan 23, 2014	Supplement 22Manufacturing · Priority review	Approved	None posted
Sep 10, 1985	Supplement 16Labeling	Approved	None posted
Nov 14, 1979	Supplement 10Manufacturing · Priority review	Approved	None posted
Nov 14, 1979	Supplement 11Manufacturing · Priority review	Approved	None posted
Feb 7, 1978	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 31, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 9190
Drugs@FDA: Overview at FDA
Company: Guerbet

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