← FDA DRUG APPROVALS

FDA ANDA · ANDA040153

TRIFLUOPERAZINE HYDROCHLORIDE

Sponsor: POM PHARMA

APPLICATION
ANDA040153
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-25
LATEST ACTION
2008-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRIFLUOPERAZINE HYDROCHLORIDEDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
TRIFLUOPERAZINE HYDROCHLORIDEDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
TRIFLUOPERAZINE HYDROCHLORIDEDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
TRIFLUOPERAZINE HYDROCHLORIDEDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL

Approval history

2008-09-03Labeling · Supplement 3AP
2002-09-04Manufacturing (CMC) · Supplement 2AP
2002-09-04Manufacturing (CMC) · Supplement 1AP
1996-10-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →