Ethamolin

Treats esophageal varices. NDA 19357, held by Qol Medcl. Ethanolamine Oleate.

As of Nov 13, 2026, NDA 19357 (Ethamolin), held by Qol Medcl, was first approved by FDA on Dec 22, 1988, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1988
Review: Priority
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN is not

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 22, 1988	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ethamolin50MG/ML · injectable;injection	Ethanolamine Oleate	RxReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 7, 2014	Supplement 18Manufacturing · Priority review	Approved	None posted
Sep 5, 2013	Supplement 20Manufacturing · Priority review	Approved	None posted
Sep 20, 2002	Supplement 15Manufacturing · Priority review	Approved	None posted
Feb 5, 2002	Supplement 14Labeling · Standard review	Approved	Letter
Apr 20, 2001	Supplement 13Manufacturing · Priority review	Approved	None posted
Jun 16, 1998	Supplement 11Manufacturing · Priority review	Approved	None posted
Jun 16, 1998	Supplement 12Manufacturing · Priority review	Approved	None posted
Jan 3, 1997	Supplement 10Manufacturing · Priority review	Approved	None posted
Oct 1, 1996	Supplement 9Manufacturing · Priority review	Approved	None posted
Jan 29, 1993	Supplement 6Manufacturing · Priority review	Approved	None posted
Jan 29, 1993	Supplement 8Labeling	Approved	None posted
Sep 15, 1992	Supplement 7Manufacturing · Priority review	Approved	None posted
Aug 26, 1992	Supplement 5Manufacturing · Priority review	Approved	None posted
Jun 3, 1992	Supplement 4Manufacturing · Priority review	Approved	None posted
Apr 10, 1992	Supplement 3Manufacturing · Priority review	Approved	None posted
Jan 18, 1991	Supplement 1Labeling	Approved	None posted
Dec 22, 1988	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19357
Drugs@FDA: Overview at FDA
Company: QOL Medical

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