APPLICATION
ANDA071523
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-11
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 74 · standardAP
2022-11-09Labeling · Supplement 66 · standardAP
2022-11-09Labeling · Supplement 58 · standardAP
2016-02-24Manufacturing (CMC) · Supplement 47AP
2014-07-18Labeling · Supplement 51 · standardAP
2014-07-11Labeling · Supplement 50 · standardAP
2014-07-01Labeling · Supplement 49 · standardAP
2009-07-08Labeling · Supplement 37AP
2008-08-13Labeling · Supplement 34AP
2007-06-25Labeling · Supplement 31AP
2005-11-29Labeling · Supplement 21AP
2005-07-08Labeling · Supplement 20AP
2002-11-12Labeling · Supplement 17AP
2001-03-30Manufacturing (CMC) · Supplement 12AP
2000-10-25Labeling · Supplement 11AP
2000-07-07Manufacturing (CMC) · Supplement 10AP
1999-03-22Manufacturing (CMC) · Supplement 9AP
1996-10-04Manufacturing (CMC) · Supplement 7AP
1996-04-22Labeling · Supplement 6AP
1994-05-11Manufacturing (CMC) · Supplement 5AP
1992-04-30Labeling · Supplement 4AP
1991-12-16Labeling · Supplement 3AP
1988-09-20Manufacturing (CMC) · Supplement 1AP
1987-12-11OriginalAP
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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