APPLICATION
ANDA088004
TYPE
ANDA
ORIGINAL APPROVAL
1983-11-18
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
THIORIDAZINE HYDROCHLORIDEPrescription
THIORIDAZINE HYDROCHLORIDE 25MG · TABLET · ORAL
THIORIDAZINE HYDROCHLORIDEPrescription
THIORIDAZINE HYDROCHLORIDE 100MG · TABLET · ORAL
THIORIDAZINE HYDROCHLORIDEPrescription
THIORIDAZINE HYDROCHLORIDE 50MG · TABLET · ORAL
THIORIDAZINE HYDROCHLORIDEPrescription
THIORIDAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 47 · standardAP
2017-02-23Labeling · Supplement 38 · standardAP
2010-12-03Labeling · Supplement 35AP
2009-06-12Labeling · Supplement 34AP
2009-01-23Labeling · Supplement 33AP
2008-04-25Manufacturing (CMC) · Supplement 31AP
2002-09-05Labeling · Supplement 27AP
2001-08-14Labeling · Supplement 26AP
1998-02-25Manufacturing (CMC) · Supplement 24AP
1998-02-05Manufacturing (CMC) · Supplement 25AP
1997-02-24Manufacturing (CMC) · Supplement 23AP
1993-09-15Manufacturing (CMC) · Supplement 22AP
1991-05-31Labeling · Supplement 20AP
1991-05-17Labeling · Supplement 19AP
1990-12-20Manufacturing (CMC) · Supplement 14AP
1990-12-20Manufacturing (CMC) · Supplement 13AP
1990-10-31Labeling · Supplement 18AP
1990-03-30Labeling · Supplement 17AP
1990-01-04Labeling · Supplement 49AP
1990-01-04Labeling · Supplement 16AP
1989-03-29Bioequivalence · Supplement 15AP
1988-05-20Labeling · Supplement 12AP
1988-05-20Labeling · Supplement 10AP
1988-05-06Manufacturing (CMC) · Supplement 11AP
1985-05-28Manufacturing (CMC) · Supplement 1AP
1984-07-03Manufacturing (CMC) · Supplement 3AP
1984-04-10Manufacturing (CMC) · Supplement 4AP
1983-11-18OriginalAP
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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