Mexitil

NDA 18873, held by Boehringer Ingelheim. Mexiletine Hydrochloride.

As of Nov 13, 2026, NDA 18873 (Mexitil), held by Boehringer Ingelheim, was first approved by FDA on Dec 30, 1985, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1985
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Oct 21, 1991	Supplement 13Efficacy (new indication or use)	Approved	None posted
Dec 30, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Products

3 strengths and forms


Mexitil150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Mexiletine Hydrochloride	DiscontinuedReference drug
Mexitil200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Mexiletine Hydrochloride	DiscontinuedReference drug
Mexitil250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Mexiletine Hydrochloride	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Feb 25, 2004	Supplement 18Labeling · Standard review	Approved	Letter
Dec 9, 2002	Supplement 17Manufacturing · Priority review	Approved	None posted
Sep 30, 1999	Supplement 16Manufacturing · Priority review	Approved	None posted
May 10, 1996	Supplement 15Labeling · Standard review	Approved	None posted
Sep 19, 1995	Supplement 14Manufacturing · Priority review	Approved	None posted
Jan 3, 1992	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 21, 1991	Supplement 13Efficacy (new indication or use)	Approved	None posted
Oct 21, 1991	Supplement 10Labeling	Approved	None posted
Oct 21, 1991	Supplement 9Labeling	Approved	None posted
Oct 21, 1991	Supplement 7Labeling	Approved	None posted
Aug 13, 1991	Supplement 12Manufacturing · Priority review	Approved	None posted
Mar 22, 1989	Supplement 8Manufacturing · Priority review	Approved	None posted
Dec 22, 1988	Supplement 6Manufacturing · Priority review	Approved	None posted
Jun 3, 1988	Supplement 5Labeling	Approved	None posted
Dec 10, 1987	Supplement 2Labeling	Approved	None posted
Sep 10, 1987	Supplement 4Manufacturing · Priority review	Approved	None posted
May 5, 1987	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 30, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 18873
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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