Loperamide Hydrochloride

ANDA 73243, held by Perrigo. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 73243 (Loperamide Hydrochloride), held by Perrigo, was first approved by FDA on Jan 21, 1992, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 21, 1992
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 21, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loperamide Hydrochloride1MG/5ML · solution;oral	Loperamide Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Sep 6, 2007	Supplement 31Labeling	Approved	None posted
Nov 26, 2001	Supplement 12Labeling	Approved	None posted
Jun 29, 1999	Supplement 9Labeling	Approved	None posted
Jun 29, 1999	Supplement 10Manufacturing	Approved	None posted
Apr 17, 1996	Supplement 6Manufacturing	Approved	None posted
Mar 25, 1996	Supplement 5Labeling	Approved	None posted
Mar 25, 1996	Supplement 7Labeling	Approved	None posted
Jun 20, 1994	Supplement 3Manufacturing	Approved	None posted
Jun 2, 1994	Supplement 4Labeling	Approved	None posted
Aug 30, 1993	Supplement 2Manufacturing	Approved	None posted
Jan 21, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73243
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