Marplan

Treats depression. NDA 11961, held by Lifsa Drugs. Isocarboxazid.

As of Nov 13, 2026, NDA 11961 (Marplan), held by Lifsa Drugs, was first approved by FDA on Jul 1, 1959, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 1, 1959
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Marplan is indicated for the treatment of depression. Because of its potentially serious side effects, Marplan is not an antidepressant of first choice in the treatment of newly diagnosed depressed patients. The efficacy of Marplan in the treatment of depression was established in 6-week controlled trials of depressed outpatients. These patients had symptoms that corresponded to the DSM-IV category of major depressive disorder; however, they often also had signs and symptoms of anxiety (anxious mood, panic, and/or phobic symptoms) ( see CLINICAL PHARMACOLOGY ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Aug 18, 1998	Supplement 17Efficacy (new indication or use)	Approved	Review Label Letter
Jul 1, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Marplan10MG · tablet;oral	Isocarboxazid	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Nov 8, 2018	Supplement 45Labeling · Standard review	Approved	Letter Label Medication Guide
Nov 2, 2016	Supplement 44Manufacturing · Standard review	Approved	None posted
Aug 10, 2007	Supplement 39Labeling · Standard review	Approved	Letter Label
Feb 12, 2007	Supplement 38Manufacturing	Approved	None posted
Jan 12, 2005	Supplement 35Labeling · Standard review	Approved	Letter Label
Oct 25, 2001	Supplement 34Manufacturing · Standard review	Approved	None posted
Jun 23, 2000	Supplement 33Labeling · Standard review	Approved	None posted
Aug 19, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 18, 1998	Supplement 17Efficacy (new indication or use)	Approved	Review Label Letter
Jun 16, 1993	Supplement 31Manufacturing · Standard review	Approved	None posted
Jul 1, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11961
Drugs@FDA: Overview at FDA
Company: Lifsa Drugs

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