Ergamisol

NDA 20035, held by Janssen Pharma. Levamisole Hydrochloride.

As of Nov 13, 2026, NDA 20035 (Ergamisol), held by Janssen Pharma, was first approved by FDA on Jun 18, 1990, with 12 approved supplements and 0 published complete response letters.

First approved: Jun 18, 1990
Review: Priority
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jun 18, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ErgamisolEQ 50MG BASE · tablet;oral	Levamisole Hydrochloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 20, 1999	Supplement 13Labeling · Priority review	Approved	None posted
Oct 23, 1998	Supplement 11Labeling · Priority review	Approved	None posted
Jul 16, 1998	Supplement 12Manufacturing · Priority review	Approved	None posted
May 27, 1998	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 16, 1996	Supplement 9Labeling · Priority review	Approved	None posted
Nov 22, 1995	Supplement 8Manufacturing · Priority review	Approved	None posted
Oct 20, 1994	Supplement 7Manufacturing · Priority review	Approved	None posted
Apr 11, 1994	Supplement 6Manufacturing · Priority review	Approved	None posted
Dec 17, 1993	Supplement 5Labeling · Priority review	Approved	None posted
Dec 14, 1992	Supplement 4Manufacturing · Priority review	Approved	None posted
May 26, 1992	Supplement 3Labeling · Priority review	Approved	None posted
Mar 10, 1992	Supplement 2Labeling · Priority review	Approved	None posted
Jun 18, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20035
Drugs@FDA: Overview at FDA
Company: Janssen 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