APPLICATION
ANDA071530
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-24
LATEST ACTION
2011-11-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
THIOTHIXENEDiscontinued
THIOTHIXENE 10MG · CAPSULE · ORAL
Approval history
2011-11-08Labeling · Supplement 22AP
2010-01-06Labeling · Supplement 20AP
2008-10-30Labeling · Supplement 19AP
2008-05-22Labeling · Supplement 17AP
2008-05-22Labeling · Supplement 18AP
2007-12-31Labeling · Supplement 16AP
2003-07-30Labeling · Supplement 14AP
2002-08-29Labeling · Supplement 13AP
2001-11-06Manufacturing (CMC) · Supplement 12AP
2001-08-07Manufacturing (CMC) · Supplement 11AP
2001-02-08Manufacturing (CMC) · Supplement 10AP
1999-05-05Manufacturing (CMC) · Supplement 9AP
1998-09-25Manufacturing (CMC) · Supplement 7AP
1998-09-25Labeling · Supplement 8AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1995-04-18Manufacturing (CMC) · Supplement 5AP
1991-07-03Labeling · Supplement 4AP
1988-02-17Manufacturing (CMC) · Supplement 1AP
1987-06-24OriginalAP
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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