← FDA DRUG APPROVALS

FDA ANDA · ANDA088872

THIORIDAZINE HYDROCHLORIDE

Sponsor: WATSON LABS TEVA

APPLICATION
ANDA088872
TYPE
ANDA
ORIGINAL APPROVAL
1985-04-26
LATEST ACTION
2017-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 200MG · TABLET · ORAL

Approval history

2017-02-23Labeling · Supplement 14 · standardAP
2015-11-03Labeling · Supplement 13AP
1991-08-07Manufacturing (CMC) · Supplement 9AP
1991-01-28Manufacturing (CMC) · Supplement 10AP
1990-08-09Labeling · Supplement 11AP
1990-06-29Manufacturing (CMC) · Supplement 8AP
1989-05-17Bioequivalence · Supplement 3AP
1985-04-26OriginalAP
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 →