Loperamide Hydrochloride

ANDA 73079, held by Allied. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 73079 (Loperamide Hydrochloride), held by Allied, was first approved by FDA on Apr 30, 1992, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1992
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loperamide Hydrochloride1MG/5ML · solution;oral	Loperamide Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Oct 14, 1998	Supplement 7Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 5Labeling	Approved	None posted
Aug 28, 1996	Supplement 4Manufacturing	Approved	None posted
Mar 29, 1993	Supplement 1Manufacturing	Approved	None posted
Mar 29, 1993	Supplement 2Labeling	Approved	None posted
Apr 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73079
Drugs@FDA: Overview at FDA
Company: Allied

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