Loperamide Hydrochloride

ANDA 74194, held by Perrigo. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 74194 (Loperamide Hydrochloride), held by Perrigo, was first approved by FDA on Oct 30, 1992, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1992
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 30, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loperamide Hydrochloride2MG · tablet;oral	Loperamide Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Nov 20, 2001	Supplement 8Labeling	Approved	None posted
Jan 24, 1997	Supplement 5Labeling	Approved	None posted
Jan 24, 1997	Supplement 6Labeling	Approved	None posted
Jun 5, 1995	Supplement 4Labeling	Approved	None posted
Mar 1, 1995	Supplement 2Manufacturing	Approved	None posted
Jul 1, 1994	Supplement 1Labeling	Approved	None posted
Oct 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 74194
Drugs@FDA: Overview at FDA
Company: Perrigo

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