APPLICATION
ANDA088479
TYPE
ANDA
ORIGINAL APPROVAL
1983-11-08
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 18 · standardAP
2017-02-23Labeling · Supplement 17 · standardAP
2015-11-03Labeling · Supplement 16AP
1991-08-07Manufacturing (CMC) · Supplement 12AP
1991-01-28Manufacturing (CMC) · Supplement 13AP
1990-08-09Labeling · Supplement 14AP
1990-06-29Manufacturing (CMC) · Supplement 6AP
1989-08-10Bioequivalence · Supplement 10AP
1989-08-10Bioequivalence · Supplement 9AP
1984-11-15Manufacturing (CMC) · Supplement 2AP
1983-11-08OriginalAP
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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