Thioridazine Hydrochloride

ANDA 88872, held by Watson Labs Teva. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88872 (Thioridazine Hydrochloride), held by Watson Labs Teva, was first approved by FDA on Apr 26, 1985, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1985
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 26, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride200MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Feb 23, 2017	Supplement 14Labeling · Standard review	Approved	None posted
Nov 3, 2015	Supplement 13Labeling	Approved	None posted
Aug 7, 1991	Supplement 9Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 10Manufacturing	Approved	None posted
Aug 9, 1990	Supplement 11Labeling	Approved	None posted
Jun 29, 1990	Supplement 8Manufacturing	Approved	None posted
May 17, 1989	Supplement 3Bioequivalence	Approved	None posted
Apr 26, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88872
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

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