APPLICATION
ANDA073137
TYPE
ANDA
ORIGINAL APPROVAL
1993-03-24
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAZODONE HYDROCHLORIDEPrescription
TRAZODONE HYDROCHLORIDE 150MG · TABLET · ORAL
TRAZODONE HYDROCHLORIDEPrescription
TRAZODONE HYDROCHLORIDE 100MG · TABLET · ORAL
TRAZODONE HYDROCHLORIDEPrescription
TRAZODONE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 47 · standardAP
2021-06-07Labeling · Supplement 42 · standardAP
2021-06-07Labeling · Supplement 41 · standardAP
2014-07-17Labeling · Supplement 34 · standardAP
2014-06-25Labeling · Supplement 33 · standardAP
2013-07-30Labeling · Supplement 32 · standardAP
2007-11-13Labeling · Supplement 28AP
2007-11-13Labeling · Supplement 27AP
2007-06-25Labeling · Supplement 26AP
2005-08-26Labeling · Supplement 22AP
2005-05-05Labeling · Supplement 21AP
2003-05-07Labeling · Supplement 15AP
2002-02-14Manufacturing (CMC) · Supplement 12AP
2001-03-13Labeling · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 10AP
2000-05-16Manufacturing (CMC) · Supplement 9AP
1998-04-27Manufacturing (CMC) · Supplement 7AP
1998-04-27Manufacturing (CMC) · Supplement 8AP
1998-04-27Manufacturing (CMC) · Supplement 6AP
1998-02-04Manufacturing (CMC) · Supplement 4AP
1997-12-05Manufacturing (CMC) · Supplement 5AP
1997-02-24Manufacturing (CMC) · Supplement 3AP
1995-06-22Manufacturing (CMC) · Supplement 2AP
1994-01-12Manufacturing (CMC) · Supplement 1AP
1993-03-24OriginalAP
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.
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.