Loperamide Hydrochloride

ANDA 74352, held by Pai Holdings. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 74352 (Loperamide Hydrochloride), held by Pai Holdings, was first approved by FDA on Nov 17, 1995, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 17, 1995
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 17, 1995	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Feb 27, 2015	Supplement 4Manufacturing	Approved	None posted
Mar 19, 2001	Supplement 1Manufacturing	Approved	None posted
Mar 19, 2001	Supplement 2Labeling	Approved	None posted
Nov 17, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74352
Drugs@FDA: Overview at FDA
Company: PAI Holdings LLC

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