Loperamide Hydrochloride

Relieves acute nonspecific diarrhea. ANDA 73192, held by Teva. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 73192 (Loperamide Hydrochloride), held by Teva, was first approved by FDA on Apr 30, 1992, with 21 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1992
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Loperamide hydrochloride is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loperamide Hydrochloride2MG · capsule;oral	Loperamide Hydrochloride	Rx

All 22 submissions, including labeling and manufacturing supplements


Nov 3, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Nov 13, 2012	Supplement 24Labeling	Approved	None posted
Jun 27, 2007	Supplement 22Labeling	Approved	None posted
Aug 30, 2001	Supplement 18Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 17Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 16Manufacturing	Approved	None posted
Oct 9, 1997	Supplement 15Manufacturing	Approved	None posted
Dec 13, 1996	Supplement 14Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 13Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 12Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 11Manufacturing	Approved	None posted
Aug 29, 1995	Supplement 10Labeling	Approved	None posted
Mar 2, 1995	Supplement 9Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 8Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 7Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 6Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 5Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 4Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 3Manufacturing	Approved	None posted
Jan 13, 1994	Supplement 1Manufacturing	Approved	None posted
Apr 1, 1993	Supplement 2Manufacturing	Approved	None posted
Apr 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73192
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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