Loperamide Hydrochloride

ANDA 206548, held by Aurobindo Pharma. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 206548 (Loperamide Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Dec 15, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2015
Review: Standard
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
Dec 15, 2015	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Jul 9, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Jul 9, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Jul 9, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jul 9, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 28, 2019	Supplement 1Manufacturing	Approved	None posted
Dec 15, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 206548
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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