APPLICATION
ANDA071636
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-18
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAZODONE HYDROCHLORIDEDiscontinued
TRAZODONE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 31 · standardAP
2020-06-09Labeling · Supplement 30 · standardAP
2014-07-17Labeling · Supplement 29 · standardAP
2005-08-15Labeling · Supplement 23AP
2005-01-06Labeling · Supplement 21AP
2002-10-31Labeling · Supplement 16AP
2001-11-02Manufacturing (CMC) · Supplement 15AP
2000-10-18Labeling · Supplement 14AP
2000-09-12Manufacturing (CMC) · Supplement 12AP
2000-09-12Manufacturing (CMC) · Supplement 10AP
2000-09-12Manufacturing (CMC) · Supplement 9AP
2000-09-12Labeling · Supplement 13AP
2000-09-12Manufacturing (CMC) · Supplement 11AP
1996-01-18Manufacturing (CMC) · Supplement 6AP
1995-11-22Labeling · Supplement 7AP
1995-04-10Labeling · Supplement 5AP
1994-04-28Manufacturing (CMC) · Supplement 4AP
1991-12-30Labeling · Supplement 3AP
1991-10-22Labeling · Supplement 2AP
1991-09-30Manufacturing (CMC) · Supplement 1AP
1988-04-18OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.