Trifluoperazine Hydrochloride

ANDA 88143, held by Wockhardt. Trifluoperazine Hydrochloride.

As of Nov 15, 2026, ANDA 88143 (Trifluoperazine Hydrochloride), held by Wockhardt, was first approved by FDA on Jul 26, 1983, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1983
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
Jul 26, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trifluoperazine HydrochlorideEQ 10MG BASE/ML · concentrate;oral	Trifluoperazine Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Apr 17, 1992	Supplement 10Labeling	Approved	None posted
Sep 15, 1989	Supplement 9Labeling	Approved	None posted
May 18, 1987	Supplement 4Manufacturing	Approved	None posted
May 18, 1987	Supplement 3Manufacturing	Approved	None posted
Jul 26, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88143
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