APPLICATION
ANDA071524
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 100MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 76 · standardAP
2022-11-09Labeling · Supplement 69 · standardAP
2022-11-09Labeling · Supplement 59 · standardAP
2014-07-18Labeling · Supplement 51 · standardAP
2014-07-11Labeling · Supplement 50 · standardAP
2014-07-01Labeling · Supplement 49 · standardAP
2009-07-08Labeling · Supplement 38AP
2008-08-13Labeling · Supplement 35AP
2007-06-25Labeling · Supplement 33AP
2005-11-29Labeling · Supplement 23AP
2005-07-08Labeling · Supplement 22AP
2002-11-12Labeling · Supplement 19AP
2001-03-30Manufacturing (CMC) · Supplement 14AP
2000-10-25Labeling · Supplement 13AP
2000-07-07Manufacturing (CMC) · Supplement 12AP
1999-03-22Manufacturing (CMC) · Supplement 11AP
1999-03-22Manufacturing (CMC) · Supplement 10AP
1996-10-04Manufacturing (CMC) · Supplement 8AP
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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