APPLICATION
ANDA088736
TYPE
ANDA
ORIGINAL APPROVAL
1984-07-24
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 13 · standardAP
2017-02-23Labeling · Supplement 12 · standardAP
2015-11-03Labeling · Supplement 11AP
1991-08-07Manufacturing (CMC) · Supplement 7AP
1991-01-28Manufacturing (CMC) · Supplement 8AP
1990-08-09Labeling · Supplement 9AP
1988-12-21Manufacturing (CMC) · Supplement 4AP
1988-12-21Manufacturing (CMC) · Supplement 5AP
1988-12-21Manufacturing (CMC) · Supplement 3AP
1984-07-24OriginalAP
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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