APPLICATION
ANDA071258
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-25
LATEST ACTION
2026-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAZODONE HYDROCHLORIDEPrescription
TRAZODONE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2026-02-09Labeling · Supplement 52 · standardAP
2025-06-24Labeling · Supplement 51 · standardAP
2023-03-22Labeling · Supplement 49 · standardAP
2020-04-20Labeling · Supplement 47 · standardAP
2020-04-20Labeling · Supplement 45 · standardAP
2014-09-11Labeling · Supplement 41 · standardAP
2008-08-11Labeling · Supplement 35AP
2007-06-25Labeling · Supplement 31AP
2005-07-08Labeling · Supplement 29AP
2005-04-08Labeling · Supplement 28AP
2003-01-21Labeling · Supplement 24AP
2000-09-13Labeling · Supplement 22AP
2000-07-07Manufacturing (CMC) · Supplement 20AP
1999-12-21Manufacturing (CMC) · Supplement 21AP
1999-05-20Manufacturing (CMC) · Supplement 19AP
1999-03-11Manufacturing (CMC) · Supplement 18AP
1998-12-01Manufacturing (CMC) · Supplement 17AP
1998-09-25Manufacturing (CMC) · Supplement 16AP
1997-05-06Manufacturing (CMC) · Supplement 15AP
1996-09-18Labeling · Supplement 14AP
1994-12-23Manufacturing (CMC) · Supplement 13AP
1994-10-11Manufacturing (CMC) · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1991-09-23Labeling · Supplement 8AP
1991-08-06Labeling · Supplement 7AP
1988-10-26Manufacturing (CMC) · Supplement 5AP
1987-11-20Manufacturing (CMC) · Supplement 1AP
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.