APPLICATION
ANDA088229
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-23
LATEST ACTION
2017-02-23
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 100MG/ML · CONCENTRATE · ORAL
Approval history
2017-02-23Labeling · Supplement 25 · standardAP
2015-11-03Labeling · Supplement 24AP
2002-07-24Manufacturing (CMC) · Supplement 19AP
2001-11-26Labeling · Supplement 18AP
2000-11-20Manufacturing (CMC) · Supplement 17AP
2000-10-23Manufacturing (CMC) · Supplement 16AP
1997-12-05Manufacturing (CMC) · Supplement 14AP
1997-09-25Manufacturing (CMC) · Supplement 13AP
1990-09-28Manufacturing (CMC) · Supplement 10AP
1989-10-31Labeling · Supplement 8AP
1986-09-03Manufacturing (CMC) · Supplement 5AP
1983-08-23OriginalAP
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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