Thioridazine Hydrochloride

ANDA 88869, held by Watson Labs. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88869 (Thioridazine Hydrochloride), held by Watson Labs, was first approved by FDA on Jun 28, 1985, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1985
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
Jun 28, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride150MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Feb 23, 2017	Supplement 13Labeling · Standard review	Approved	None posted
Nov 3, 2015	Supplement 12Labeling	Approved	None posted
Nov 23, 1992	Supplement 7Manufacturing	Approved	None posted
Nov 23, 1992	Supplement 5Manufacturing	Approved	None posted
Nov 23, 1992	Supplement 4Manufacturing	Approved	None posted
Nov 23, 1992	Supplement 3Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 9Manufacturing	Approved	None posted
Aug 9, 1990	Supplement 10Labeling	Approved	None posted
Jun 29, 1990	Supplement 2Manufacturing	Approved	None posted
Jun 28, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88869
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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