Loperamide Hydrochloride

ANDA 91292, held by Perrigo R And D. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 91292 (Loperamide Hydrochloride), held by Perrigo R And D, was first approved by FDA on May 20, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: May 20, 2011
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use controls symptoms of diarrhea, including Travelers’ Diarrhea

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 20, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loperamide Hydrochloride1MG/7.5ML · solution;oral	Loperamide Hydrochloride	OTC

All 5 submissions, including labeling and manufacturing supplements


Dec 13, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Dec 13, 2021	Supplement 16Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 8Labeling · Standard review	Approved	None posted
May 20, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91292
Drugs@FDA: Overview at FDA
Company: Perrigo R&D

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