Ethmozine

NDA 19753, held by Shire. Moricizine Hydrochloride.

As of Nov 14, 2026, NDA 19753 (Ethmozine), held by Shire, was first approved by FDA on Jun 19, 1990, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1990
Review: Priority
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 19, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


Ethmozine200MG · tablet;oral	Moricizine Hydrochloride	Discontinued
Ethmozine250MG · tablet;oral	Moricizine Hydrochloride	Discontinued
Ethmozine300MG · tablet;oral	Moricizine Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


May 27, 1997	Supplement 8Labeling · Standard review	Approved	None posted
Oct 11, 1996	Supplement 9Manufacturing · Priority review	Approved	None posted
Sep 16, 1992	Supplement 5Labeling	Approved	None posted
Jul 8, 1992	Supplement 7Manufacturing · Priority review	Approved	None posted
Jun 22, 1992	Supplement 6Manufacturing · Priority review	Approved	None posted
Sep 20, 1991	Supplement 3Labeling	Approved	None posted
Aug 23, 1990	Supplement 1Manufacturing · Priority review	Approved	None posted
Jun 19, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19753
Drugs@FDA: Overview at FDA
Company: Shire

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