APPLICATION
ANDA072192
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-02
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAZODONE HYDROCHLORIDEPrescription
TRAZODONE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 58 · standardAP
2020-05-19Labeling · Supplement 54 · standardAP
2020-05-19Labeling · Supplement 51 · standardAP
2015-06-15Labeling · Supplement 46 · standardAP
2015-05-12Manufacturing (CMC) · Supplement 41AP
2007-10-29Labeling · Supplement 40AP
2007-06-26Labeling · Supplement 39AP
2005-08-15Labeling · Supplement 37AP
2005-01-05Labeling · Supplement 31AP
2002-12-26Labeling · Supplement 29AP
2002-02-20Manufacturing (CMC) · Supplement 28AP
2001-01-04Labeling · Supplement 27AP
2000-05-26Manufacturing (CMC) · Supplement 23AP
2000-05-26Labeling · Supplement 24AP
1999-12-02Manufacturing (CMC) · Supplement 26AP
1999-12-02Manufacturing (CMC) · Supplement 25AP
1999-02-12Manufacturing (CMC) · Supplement 15AP
1999-02-12Manufacturing (CMC) · Supplement 16AP
1998-02-18Manufacturing (CMC) · Supplement 14AP
1997-10-09Manufacturing (CMC) · Supplement 13AP
1997-05-07Manufacturing (CMC) · Supplement 12AP
1996-12-11Manufacturing (CMC) · Supplement 11AP
1996-08-16Manufacturing (CMC) · Supplement 10AP
1996-04-30Manufacturing (CMC) · Supplement 9AP
1993-05-05Manufacturing (CMC) · Supplement 8AP
1992-04-06Manufacturing (CMC) · Supplement 6AP
1992-04-06Manufacturing (CMC) · Supplement 4AP
1992-04-06Manufacturing (CMC) · Supplement 2AP
1992-03-04Labeling · Supplement 7AP
1991-09-13Labeling · Supplement 5AP
1991-08-22Manufacturing (CMC) · Supplement 3AP
1989-02-02OriginalAP
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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