APPLICATION
ANDA070602
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-05
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
THIOTHIXENEDiscontinued
THIOTHIXENE 5MG · CAPSULE · ORAL
Approval history
2025-01-22Labeling · Supplement 20 · standardAP
2024-12-12Labeling · Supplement 19 · standardAP
2002-09-10Labeling · Supplement 17AP
2001-04-25Manufacturing (CMC) · Supplement 18AP
1997-11-26Manufacturing (CMC) · Supplement 15AP
1995-07-20Manufacturing (CMC) · Supplement 14AP
1994-02-28Manufacturing (CMC) · Supplement 13AP
1991-12-19Manufacturing (CMC) · Supplement 7AP
1991-12-19Manufacturing (CMC) · Supplement 6AP
1990-06-29Manufacturing (CMC) · Supplement 9AP
1990-06-05Manufacturing (CMC) · Supplement 11AP
1990-06-05Labeling · Supplement 12AP
1988-04-08Manufacturing (CMC) · Supplement 5AP
1987-11-25Manufacturing (CMC) · Supplement 1AP
1987-06-05OriginalAP
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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