APPLICATION
ANDA088561
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-11
LATEST ACTION
2017-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2017-02-24Labeling · Supplement 24 · standardAP
2015-11-03Labeling · Supplement 23AP
1997-01-31Manufacturing (CMC) · Supplement 22AP
1991-02-04Labeling · Supplement 21AP
1990-09-17Labeling · Supplement 20AP
1988-07-05Labeling · Supplement 19AP
1988-04-22Labeling · Supplement 18AP
1988-03-29Manufacturing (CMC) · Supplement 17AP
1987-12-10Manufacturing (CMC) · Supplement 16AP
1987-05-15Manufacturing (CMC) · Supplement 14AP
1985-11-26Manufacturing (CMC) · Supplement 8AP
1985-11-26Manufacturing (CMC) · Supplement 9AP
1985-11-26Manufacturing (CMC) · Supplement 7AP
1985-10-08Manufacturing (CMC) · Supplement 5AP
1985-10-08Manufacturing (CMC) · Supplement 4AP
1984-05-11OriginalAP
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.