Loperamide Hydrochloride

ANDA 76497, held by Lnk. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 76497 (Loperamide Hydrochloride), held by Lnk, was first approved by FDA on Jun 10, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 10, 2003
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses 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 3 submissions below

Date	Submission	Status	Documents
Jun 10, 2003	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Apr 2, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Sep 9, 2015	Supplement 2Labeling	Approved	None posted
Jun 10, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76497
Drugs@FDA: Overview at FDA
Company: LNK

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