APPLICATION
ANDA088461
TYPE
ANDA
ORIGINAL APPROVAL
1983-11-18
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 15MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 23 · standardAP
2017-02-23Labeling · Supplement 22 · standardAP
2010-12-03Labeling · Supplement 21AP
1998-12-01Manufacturing (CMC) · Supplement 20AP
1994-12-23Manufacturing (CMC) · Supplement 19AP
1994-10-11Manufacturing (CMC) · Supplement 18AP
1992-04-03Manufacturing (CMC) · Supplement 15AP
1992-04-03Manufacturing (CMC) · Supplement 17AP
1990-02-23Labeling · Supplement 14AP
1988-08-19Labeling · Supplement 12AP
1988-06-02Labeling · Supplement 11AP
1988-03-03Manufacturing (CMC) · Supplement 9AP
1987-03-31Manufacturing (CMC) · Supplement 8AP
1986-04-08Manufacturing (CMC) · Supplement 7AP
1986-02-11Manufacturing (CMC) · Supplement 5AP
1986-02-11Manufacturing (CMC) · Supplement 4AP
1986-01-22Manufacturing (CMC) · Supplement 6AP
1984-10-05Manufacturing (CMC) · Supplement 2AP
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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