Trifluoperazine Hydrochloride

ANDA 40153, held by Pharmobedient. Trifluoperazine Hydrochloride.

As of Nov 15, 2026, ANDA 40153 (Trifluoperazine Hydrochloride), held by Pharmobedient, was first approved by FDA on Oct 25, 1996, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 25, 1996
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 25, 1996	Original application	Approved	None posted

Products

4 strengths and forms


Trifluoperazine HydrochlorideEQ 1MG BASE · tablet;oral	Trifluoperazine Hydrochloride	Discontinued
Trifluoperazine HydrochlorideEQ 2MG BASE · tablet;oral	Trifluoperazine Hydrochloride	Discontinued
Trifluoperazine HydrochlorideEQ 5MG BASE · tablet;oral	Trifluoperazine Hydrochloride	Discontinued
Trifluoperazine HydrochlorideEQ 10MG BASE · tablet;oral	Trifluoperazine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 3, 2008	Supplement 3Labeling	Approved	None posted
Sep 4, 2002	Supplement 1Manufacturing	Approved	None posted
Sep 4, 2002	Supplement 2Manufacturing	Approved	None posted
Oct 25, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 40153
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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