Thioridazine Hydrochloride

ANDA 88478, held by Heritage Pharma Avet. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88478 (Thioridazine Hydrochloride), held by Heritage Pharma Avet, was first approved by FDA on Nov 8, 1983, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 8, 1983
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
Nov 8, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride25MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 18Labeling · Standard review	Approved	None posted
Nov 3, 2015	Supplement 17Labeling	Approved	None posted
Aug 7, 1991	Supplement 13Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 14Manufacturing	Approved	None posted
Aug 31, 1990	Supplement 15Labeling	Approved	None posted
Jun 29, 1990	Supplement 7Manufacturing	Approved	None posted
Aug 10, 1989	Supplement 10Bioequivalence	Approved	None posted
Mar 19, 1984	Supplement 2Manufacturing	Approved	None posted
Nov 8, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88478
Drugs@FDA: Overview at FDA
Company: Heritage Pharma Avet

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