APPLICATION
ANDA072484
TYPE
ANDA
ORIGINAL APPROVAL
1990-04-30
LATEST ACTION
2014-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAZODONE HYDROCHLORIDEDiscontinued
TRAZODONE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2014-07-18Labeling · Supplement 14 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 10AP
2001-05-09Manufacturing (CMC) · Supplement 11AP
2000-08-30Labeling · Supplement 9AP
1999-09-10Labeling · Supplement 8AP
1999-09-10Manufacturing (CMC) · Supplement 6AP
1999-05-05Manufacturing (CMC) · Supplement 7AP
1997-04-25Manufacturing (CMC) · Supplement 5AP
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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