APPLICATION
ANDA071093
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-23
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
THIOTHIXENEPrescription
THIOTHIXENE 5MG · CAPSULE · ORAL
THIOTHIXENEPrescription
THIOTHIXENE 1MG · CAPSULE · ORAL
THIOTHIXENEPrescription
THIOTHIXENE 2MG · CAPSULE · ORAL
THIOTHIXENEPrescription
THIOTHIXENE 10MG · CAPSULE · ORAL
Approval history
2025-01-22Labeling · Supplement 33 · standardAP
2021-06-07Labeling · Supplement 30 · standardAP
2010-02-26Labeling · Supplement 24AP
2009-04-30Labeling · Supplement 21AP
2008-08-19Labeling · Supplement 19AP
2002-09-05Labeling · Supplement 14AP
1998-02-05Manufacturing (CMC) · Supplement 13AP
1995-10-24Manufacturing (CMC) · Supplement 12AP
1993-11-19Manufacturing (CMC) · Supplement 10AP
1992-11-09Manufacturing (CMC) · Supplement 2AP
1992-11-09Manufacturing (CMC) · Supplement 1AP
1990-01-31Manufacturing (CMC) · Supplement 8AP
1989-07-10Labeling · Supplement 7AP
1988-06-16Manufacturing (CMC) · Supplement 6AP
1988-06-16Manufacturing (CMC) · Supplement 5AP
1988-03-04Labeling · Supplement 4AP
1987-06-23OriginalAP
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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