Thioridazine Hydrochloride

ANDA 88227, held by Wockhardt. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88227 (Thioridazine Hydrochloride), held by Wockhardt, was first approved by FDA on Jul 5, 1983, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 5, 1983
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 5, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride100MG/ML · concentrate;oral	Thioridazine Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Oct 3, 1991	Supplement 14Labeling	Approved	None posted
Aug 16, 1990	Supplement 13Labeling	Approved	None posted
May 18, 1987	Supplement 9Manufacturing	Approved	None posted
May 18, 1987	Supplement 8Manufacturing	Approved	None posted
Sep 17, 1986	Supplement 7Manufacturing	Approved	None posted
Feb 5, 1986	Supplement 6Manufacturing	Approved	None posted
Sep 16, 1985	Supplement 5Manufacturing	Approved	None posted
Feb 5, 1985	Supplement 4Manufacturing	Approved	None posted
Nov 27, 1984	Supplement 3Manufacturing	Approved	None posted
Jan 12, 1984	Supplement 1Manufacturing	Approved	None posted
Jul 5, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88227
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