Imodium

NDA 19037, held by Janssen Pharms. Loperamide Hydrochloride.

As of Nov 13, 2026, NDA 19037 (Imodium), held by Janssen Pharms, was first approved by FDA on Jul 31, 1984, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1984
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 31, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Imodium1MG/5ML · solution;oral	Loperamide Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 16, 1987	Supplement 3Labeling · Standard review	Approved	None posted
Jun 2, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 29, 1985	Supplement 1Labeling · Standard review	Approved	None posted
Jul 31, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19037
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