APPLICATION
ANDA088477
TYPE
ANDA
ORIGINAL APPROVAL
1983-11-08
LATEST ACTION
2017-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 15MG · TABLET · ORAL
Approval history
2017-02-23Labeling · Supplement 17 · standardAP
2015-11-03Labeling · Supplement 16AP
1991-08-07Manufacturing (CMC) · Supplement 7AP
1991-04-30Manufacturing (CMC) · Supplement 9AP
1991-01-28Manufacturing (CMC) · Supplement 8AP
1991-01-15Labeling · Supplement 10AP
1983-11-08OriginalAP
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.