Thioridazine Hydrochloride

ANDA 88477, held by Watson Labs Teva. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88477 (Thioridazine Hydrochloride), held by Watson Labs Teva, was first approved by FDA on Nov 8, 1983, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 8, 1983
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 8, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride15MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Feb 23, 2017	Supplement 17Labeling · Standard review	Approved	None posted
Nov 3, 2015	Supplement 16Labeling	Approved	None posted
Aug 7, 1991	Supplement 7Manufacturing	Approved	None posted
Apr 30, 1991	Supplement 9Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 8Manufacturing	Approved	None posted
Jan 15, 1991	Supplement 10Labeling	Approved	None posted
Nov 8, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88477
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