Imodium

NDA 17690, held by J And J Consumer Inc. Loperamide Hydrochloride.

As of Nov 13, 2026, NDA 17690 (Imodium), held by J And J Consumer Inc, was first approved by FDA on Dec 28, 1976, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1976
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 28, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Imodium2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Loperamide Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 3, 2016	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 17, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 24, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 2, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 27, 1988	Supplement 1Labeling	Approved	None posted
Dec 28, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17690
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