APPLICATION
ANDA072483
TYPE
ANDA
ORIGINAL APPROVAL
1990-04-30
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAZODONE HYDROCHLORIDEDiscontinued
TRAZODONE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 14 · standardAP
2020-04-28Labeling · Supplement 13 · standardAP
2014-07-18Labeling · Supplement 12 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 8AP
2001-05-09Manufacturing (CMC) · Supplement 9AP
2000-08-30Labeling · Supplement 7AP
1999-09-10Manufacturing (CMC) · Supplement 5AP
1999-09-10Labeling · Supplement 6AP
1996-05-03Labeling · Supplement 4AP
1995-04-26Manufacturing (CMC) · Supplement 3AP
1992-05-21Labeling · Supplement 2AP
1991-12-09Manufacturing (CMC) · Supplement 1AP
1990-04-30OriginalAP
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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