Moctanin

NDA 19368, held by Ethitek. Monoctanoin.

As of Nov 13, 2026, NDA 19368 (Moctanin), held by Ethitek, was first approved by FDA on Oct 29, 1985, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1985
Review: Priority
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 29, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Moctanin100% · liquid;perfusion, biliary	Monoctanoin	Discontinued

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 12, 2002	Supplement 8Labeling	Approved	None posted
Nov 12, 2002	Supplement 7Labeling	Approved	None posted
Nov 12, 2002	Supplement 5Labeling	Approved	None posted
Nov 12, 2002	Supplement 2Labeling	Approved	None posted
Apr 3, 1992	Supplement 12Manufacturing · Priority review	Approved	None posted
Jul 3, 1991	Supplement 10Labeling	Approved	None posted
Oct 4, 1990	Supplement 9Labeling	Approved	None posted
Mar 22, 1990	Supplement 6Manufacturing · Priority review	Approved	None posted
Feb 12, 1990	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 21, 1988	Supplement 4Labeling	Approved	None posted
Dec 22, 1986	Supplement 1Manufacturing · Priority review	Approved	None posted
Oct 29, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 19368
Drugs@FDA: Overview at FDA
Company: Ethitek

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