APPLICATION
ANDA071554
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-16
LATEST ACTION
2002-09-11
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
THIOTHIXENE HYDROCHLORIDEDiscontinued
THIOTHIXENE HYDROCHLORIDE EQ 5MG BASE/ML · CONCENTRATE · ORAL
Approval history
2002-09-11Labeling · Supplement 16AP
2002-01-23Manufacturing (CMC) · Supplement 11AP
2001-10-31Manufacturing (CMC) · Supplement 13AP
2001-10-31Manufacturing (CMC) · Supplement 14AP
2001-10-31Manufacturing (CMC) · Supplement 15AP
2001-02-26Manufacturing (CMC) · Supplement 10AP
1999-06-17Manufacturing (CMC) · Supplement 8AP
1999-03-23Manufacturing (CMC) · Supplement 7AP
1998-06-11Manufacturing (CMC) · Supplement 6AP
1996-05-31Manufacturing (CMC) · Supplement 5AP
1992-11-17Manufacturing (CMC) · Supplement 3AP
1992-11-17Manufacturing (CMC) · Supplement 4AP
1991-06-07Manufacturing (CMC) · Supplement 2AP
1990-02-14Labeling · Supplement 1AP
1987-10-16OriginalAP
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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