← FDA DRUG APPROVALS

FDA ANDA · ANDA087766

THIORIDAZINE HYDROCHLORIDE

Sponsor: ALPHARMA US PHARMS

APPLICATION
ANDA087766
TYPE
ANDA
ORIGINAL APPROVAL
1983-04-26
LATEST ACTION
1990-09-28
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued

Products

THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 30MG/ML · CONCENTRATE · ORAL

Approval history

1990-09-28Manufacturing (CMC) · Supplement 9AP
1989-09-27Labeling · Supplement 8AP
1989-04-04Manufacturing (CMC) · Supplement 7AP
1986-09-19Manufacturing (CMC) · Supplement 5AP
1983-11-25Manufacturing (CMC) · Supplement 1AP
1983-04-26OriginalAP
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 →