Trifluoperazine Hydrochloride

ANDA 88969, held by Duramed Pharms Barr. Trifluoperazine Hydrochloride.

As of Nov 15, 2026, ANDA 88969 (Trifluoperazine Hydrochloride), held by Duramed Pharms Barr, was first approved by FDA on Apr 23, 1985, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 23, 1985
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 23, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trifluoperazine HydrochlorideEQ 5MG BASE · tablet;oral	Trifluoperazine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 29, 1989	Supplement 9Labeling	Approved	None posted
Apr 23, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88969
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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