Ludiomil

NDA 17543, held by Novartis. Maprotiline Hydrochloride.

As of Nov 13, 2026, NDA 17543 (Ludiomil), held by Novartis, was first approved by FDA on Dec 1, 1980, with 27 approved supplements and 0 published complete response letters.

First approved: Dec 1, 1980
Review: Standard
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


May 29, 1981	Supplement 1Efficacy (new indication or use)	Approved	None posted
Dec 1, 1980	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Ludiomil25MG · tablet;oral	Maprotiline Hydrochloride	Discontinued
Ludiomil50MG · tablet;oral	Maprotiline Hydrochloride	Discontinued
Ludiomil75MG · tablet;oral	Maprotiline Hydrochloride	Discontinued

All 28 submissions, including labeling and manufacturing supplements


Apr 10, 1997	Supplement 30Labeling · Standard review	Approved	None posted
Apr 10, 1997	Supplement 29Labeling · Standard review	Approved	None posted
Apr 10, 1997	Supplement 26Labeling	Approved	None posted
Apr 10, 1997	Supplement 21Labeling	Approved	None posted
Apr 10, 1997	Supplement 19Labeling	Approved	None posted
Apr 10, 1997	Supplement 18Labeling	Approved	None posted
Mar 5, 1996	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 28, 1994	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 28, 1994	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 12, 1993	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 27, 1990	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 7, 1989	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 26, 1985	Supplement 16Labeling	Approved	None posted
Mar 21, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 4, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 16, 1983	Supplement 14Labeling	Approved	None posted
Jan 12, 1983	Supplement 9Labeling	Approved	None posted
Nov 17, 1982	Supplement 12Labeling	Approved	None posted
Nov 8, 1982	Supplement 11Labeling	Approved	None posted
Oct 21, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 30, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 3, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 3, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 3, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 3, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 3, 1981	Supplement 4Labeling	Approved	None posted
May 29, 1981	Supplement 1Efficacy (new indication or use)	Approved	None posted
Dec 1, 1980	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17543
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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