APPLICATION
ANDA040209
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-07
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIFLUOPERAZINE HYDROCHLORIDEPrescription
TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
TRIFLUOPERAZINE HYDROCHLORIDEPrescription
TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
TRIFLUOPERAZINE HYDROCHLORIDEPrescription
TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
TRIFLUOPERAZINE HYDROCHLORIDEPrescription
TRIFLUOPERAZINE HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 22 · standardAP
2025-01-14Labeling · Supplement 21 · standardAP
2010-12-03Labeling · Supplement 11AP
2009-05-22Labeling · Supplement 9AP
2008-09-08Labeling · Supplement 8AP
2008-08-19Labeling · Supplement 5AP
2003-06-13Labeling · Supplement 2AP
1997-07-07OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.