← FDA DRUG APPROVALS

FDA ANDA · ANDA088227

THIORIDAZINE HYDROCHLORIDE

Sponsor: WOCKHARDT

APPLICATION
ANDA088227
TYPE
ANDA
ORIGINAL APPROVAL
1983-07-05
LATEST ACTION
1991-10-03
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued

Products

THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 100MG/ML · CONCENTRATE · ORAL

Approval history

1991-10-03Labeling · Supplement 14AP
1990-08-16Labeling · Supplement 13AP
1987-05-18Manufacturing (CMC) · Supplement 9AP
1987-05-18Manufacturing (CMC) · Supplement 8AP
1986-09-17Manufacturing (CMC) · Supplement 7AP
1986-02-05Manufacturing (CMC) · Supplement 6AP
1985-09-16Manufacturing (CMC) · Supplement 5AP
1985-02-05Manufacturing (CMC) · Supplement 4AP
1984-11-27Manufacturing (CMC) · Supplement 3AP
1984-01-12Manufacturing (CMC) · Supplement 1AP
1983-07-05OriginalAP
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 →