APPLICATION
ANDA088134
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-30
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 48 · standardAP
2017-02-23Labeling · Supplement 47 · standardAP
2016-04-19Labeling · Supplement 46AP
2002-12-16Manufacturing (CMC) · Supplement 42AP
2002-09-05Labeling · Supplement 41AP
2001-08-14Labeling · Supplement 39AP
2001-02-21Manufacturing (CMC) · Supplement 40AP
1999-05-05Manufacturing (CMC) · Supplement 37AP
1998-10-20Labeling · Supplement 35AP
1998-10-20Manufacturing (CMC) · Supplement 34AP
1998-09-18Manufacturing (CMC) · Supplement 36AP
1995-03-21Manufacturing (CMC) · Supplement 33AP
1990-01-09Labeling · Supplement 32AP
1989-09-28Labeling · Supplement 31AP
1988-11-10Manufacturing (CMC) · Supplement 30AP
1987-03-18Manufacturing (CMC) · Supplement 27AP
1986-11-13Manufacturing (CMC) · Supplement 20AP
1986-11-13Manufacturing (CMC) · Supplement 19AP
1986-11-13Manufacturing (CMC) · Supplement 21AP
1986-08-29Manufacturing (CMC) · Supplement 23AP
1986-04-18Manufacturing (CMC) · Supplement 24AP
1986-04-18Manufacturing (CMC) · Supplement 16AP
1984-10-23Manufacturing (CMC) · Supplement 5AP
1984-10-23Manufacturing (CMC) · Supplement 6AP
1984-10-23Manufacturing (CMC) · Supplement 4AP
1984-10-23Manufacturing (CMC) · Supplement 15AP
1984-10-23Manufacturing (CMC) · Supplement 7AP
1984-06-28Manufacturing (CMC) · Supplement 1AP
1983-08-30OriginalAP
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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