APPLICATION
ANDA088136
TYPE
ANDA
ORIGINAL APPROVAL
1986-09-17
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 150MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 21 · standardAP
2017-02-23Labeling · Supplement 20 · standardAP
2016-04-19Labeling · Supplement 19AP
2002-12-16Manufacturing (CMC) · Supplement 15AP
2002-09-05Labeling · Supplement 14AP
2001-08-14Labeling · Supplement 12AP
2001-02-21Manufacturing (CMC) · Supplement 13AP
1999-05-05Manufacturing (CMC) · Supplement 10AP
1995-03-21Manufacturing (CMC) · Supplement 9AP
1990-01-09Labeling · Supplement 8AP
1989-09-28Labeling · Supplement 7AP
1988-11-10Manufacturing (CMC) · Supplement 6AP
1987-01-09Manufacturing (CMC) · Supplement 3AP
1987-01-09Manufacturing (CMC) · Supplement 1AP
1987-01-09Manufacturing (CMC) · Supplement 2AP
1986-09-17OriginalAP
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.
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