Thioridazine Hydrochloride

ANDA 88258, held by Wockhardt. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88258 (Thioridazine Hydrochloride), held by Wockhardt, was first approved by FDA on Jul 25, 1983, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 25, 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
Jul 25, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride30MG/ML · concentrate;oral	Thioridazine Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Oct 3, 1991	Supplement 13Labeling	Approved	None posted
Feb 14, 1990	Supplement 12Labeling	Approved	None posted
May 18, 1987	Supplement 8Manufacturing	Approved	None posted
May 18, 1987	Supplement 7Manufacturing	Approved	None posted
Sep 17, 1986	Supplement 6Manufacturing	Approved	None posted
Feb 5, 1986	Supplement 5Manufacturing	Approved	None posted
Sep 16, 1985	Supplement 4Manufacturing	Approved	None posted
Feb 5, 1985	Supplement 3Manufacturing	Approved	None posted
Nov 28, 1984	Supplement 2Manufacturing	Approved	None posted
Jul 25, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88258
Drugs@FDA: Overview at FDA
Company: Wockhardt

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