APPLICATION
ANDA071405
TYPE
ANDA
ORIGINAL APPROVAL
1991-02-27
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAZODONE HYDROCHLORIDEDiscontinued
TRAZODONE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 8 · standardAP
2020-04-29Labeling · Supplement 6 · standardAP
2014-07-17Labeling · Supplement 5 · standardAP
1998-02-05Manufacturing (CMC) · Supplement 4AP
1992-01-14Labeling · Supplement 2AP
1991-10-28Manufacturing (CMC) · Supplement 1AP
1991-02-27OriginalAP
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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