APPLICATION
ANDA089602
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-09
LATEST ACTION
1999-06-17
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 30MG/ML · CONCENTRATE · ORAL
Approval history
1999-06-17Manufacturing (CMC) · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 6AP
1998-06-11Manufacturing (CMC) · Supplement 5AP
1996-05-31Manufacturing (CMC) · Supplement 4AP
1992-11-17Manufacturing (CMC) · Supplement 3AP
1992-07-07Manufacturing (CMC) · Supplement 2AP
1991-03-26Labeling · Supplement 1AP
1987-11-09OriginalAP
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.