Imodium A-D Ez Chews

NDA 20448, held by J And J Consumer Inc. Loperamide Hydrochloride.

As of Nov 13, 2026, NDA 20448 (Imodium A-D Ez Chews), held by J And J Consumer Inc, was first approved by FDA on Jul 24, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1997
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 24, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Imodium A-D Ez Chews2MG · tablet, chewable;oral	Loperamide Hydrochloride	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 12, 2017	Supplement 11Labeling · Standard review	Approved	Letter Label
May 22, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 20, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 27, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 11, 2007	Supplement 4Manufacturing · Standard review	Approved	Label Letter
Sep 10, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 4, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 24, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20448
Drugs@FDA: Overview at FDA
Company: J&J Consumer

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