Loperamide Hydrochloride

ANDA 73478, held by Teva. Loperamide Hydrochloride.

As of Nov 15, 2026, ANDA 73478 (Loperamide Hydrochloride), held by Teva, was first approved by FDA on Jun 23, 1995, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 23, 1995
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 23, 1995	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 1Manufacturing	Approved	None posted
Jun 23, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 73478
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