Thiothixene Hydrochloride

ANDA 71184, held by Teva. Thiothixene Hydrochloride.

As of Nov 15, 2026, ANDA 71184 (Thiothixene Hydrochloride), held by Teva, was first approved by FDA on Jun 22, 1987, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 22, 1987
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 22, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thiothixene HydrochlorideEQ 5MG BASE/ML · concentrate;oral	Thiothixene Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 5Manufacturing	Approved	None posted
Mar 4, 1991	Supplement 4Labeling	Approved	None posted
Feb 28, 1989	Supplement 3Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 2Labeling	Approved	None posted
Jun 22, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71184
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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