Loperamide Hydrochloride

ANDA 73254, held by Contract Pharmacal. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 73254 (Loperamide Hydrochloride), held by Contract Pharmacal, was first approved by FDA on Jul 30, 1993, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1993
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
Jul 30, 1993	Original application	Approved	None posted

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Sep 21, 2000	Supplement 10Manufacturing	Approved	None posted
Aug 16, 1999	Supplement 9Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 8Labeling	Approved	None posted
Aug 26, 1996	Supplement 7Manufacturing	Approved	None posted
Feb 28, 1996	Supplement 5Labeling	Approved	None posted
Feb 28, 1996	Supplement 6Manufacturing	Approved	None posted
Jul 25, 1995	Supplement 3Manufacturing	Approved	None posted
Aug 30, 1994	Supplement 4Manufacturing	Approved	None posted
May 27, 1994	Supplement 2Manufacturing	Approved	None posted
Jul 30, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 73254
Drugs@FDA: Overview at FDA
Company: Contract Pharmacal Corporation

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