APPLICATION
ANDA070858
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-10
LATEST ACTION
2014-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAZODONE HYDROCHLORIDEDiscontinued
TRAZODONE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2014-07-18Labeling · Supplement 46 · standardAP
2007-11-13Labeling · Supplement 40AP
2007-07-09Labeling · Supplement 38AP
2007-04-24Labeling · Supplement 37AP
2005-08-30Labeling · Supplement 30AP
2005-01-06Labeling · Supplement 27AP
2001-05-22Manufacturing (CMC) · Supplement 23AP
2001-04-25Manufacturing (CMC) · Supplement 22AP
2001-04-11Manufacturing (CMC) · Supplement 20AP
2001-02-20Manufacturing (CMC) · Supplement 21AP
2000-11-28Manufacturing (CMC) · Supplement 18AP
2000-08-01Labeling · Supplement 19AP
2000-07-21Manufacturing (CMC) · Supplement 17AP
2000-07-21Manufacturing (CMC) · Supplement 15AP
2000-07-21Manufacturing (CMC) · Supplement 16AP
2000-05-12Manufacturing (CMC) · Supplement 14AP
1999-09-20Manufacturing (CMC) · Supplement 12AP
1992-09-16Labeling · Supplement 10AP
1991-08-07Manufacturing (CMC) · Supplement 8AP
1991-01-28Manufacturing (CMC) · Supplement 9AP
1990-08-09Manufacturing (CMC) · Supplement 7AP
1988-11-07Manufacturing (CMC) · Supplement 5AP
1988-11-01Bioequivalence · Supplement 6AP
1988-04-12Manufacturing (CMC) · Supplement 4AP
1987-07-24Manufacturing (CMC) · Supplement 1AP
1986-10-10OriginalAP
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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