Loperamide Hydrochloride

ANDA 72993, held by Chartwell Rx. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 72993 (Loperamide Hydrochloride), held by Chartwell Rx, was first approved by FDA on Aug 28, 1992, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 28, 1992
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 28, 1992	Original application	Approved	None posted

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Nov 3, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Nov 6, 2001	Supplement 9Manufacturing	Approved	None posted
Jul 12, 2000	Supplement 8Manufacturing	Approved	None posted
Jul 12, 2000	Supplement 7Manufacturing	Approved	None posted
May 5, 1999	Supplement 5Manufacturing	Approved	None posted
Aug 8, 1997	Supplement 4Manufacturing	Approved	None posted
Sep 17, 1996	Supplement 3Manufacturing	Approved	None posted
Jul 10, 1996	Supplement 2Labeling	Approved	None posted
Jan 24, 1994	Supplement 1Manufacturing	Approved	None posted
Aug 28, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 72993
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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