APPLICATION
ANDA088135
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-20
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 36 · standardAP
2017-02-23Labeling · Supplement 35 · standardAP
2016-04-19Labeling · Supplement 34AP
2002-09-05Labeling · Supplement 29AP
2002-05-08Manufacturing (CMC) · Supplement 28AP
2001-08-14Labeling · Supplement 25AP
2001-04-12Manufacturing (CMC) · Supplement 27AP
2001-02-21Manufacturing (CMC) · Supplement 26AP
1999-05-05Manufacturing (CMC) · Supplement 23AP
1998-10-20Labeling · Supplement 21AP
1998-10-20Manufacturing (CMC) · Supplement 20AP
1998-09-18Manufacturing (CMC) · Supplement 22AP
1995-03-21Manufacturing (CMC) · Supplement 19AP
1990-01-09Labeling · Supplement 18AP
1989-09-28Labeling · Supplement 17AP
1988-11-10Manufacturing (CMC) · Supplement 16AP
1987-07-15Manufacturing (CMC) · Supplement 13AP
1987-07-15Manufacturing (CMC) · Supplement 11AP
1987-07-15Manufacturing (CMC) · Supplement 12AP
1987-01-15Manufacturing (CMC) · Supplement 10AP
1986-08-29Manufacturing (CMC) · Supplement 7AP
1986-04-18Manufacturing (CMC) · Supplement 8AP
1985-04-30Manufacturing (CMC) · Supplement 3AP
1985-04-30Manufacturing (CMC) · Supplement 4AP
1985-04-30Manufacturing (CMC) · Supplement 2AP
1984-11-20OriginalAP
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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