APPLICATION
ANDA088942
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-16
LATEST ACTION
2001-11-26
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDE INTENSOLDiscontinued
THIORIDAZINE HYDROCHLORIDE 100MG/ML · CONCENTRATE · ORAL
Approval history
2001-11-26Labeling · Supplement 8AP
1997-02-28Manufacturing (CMC) · Supplement 6AP
1996-08-28Manufacturing (CMC) · Supplement 7AP
1991-05-22Labeling · Supplement 5AP
1990-04-02Labeling · Supplement 4AP
1989-03-15Bioequivalence · Supplement 1AP
1989-02-21Manufacturing (CMC) · Supplement 2AP
1989-02-21Manufacturing (CMC) · Supplement 3AP
1985-12-16OriginalAP
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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