APPLICATION
NDA018207
TYPE
NDA
ORIGINAL APPROVAL
1981-12-24
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DESYREL · ReferenceDiscontinued
TRAZODONE HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DESYREL · ReferenceDiscontinued
TRAZODONE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DESYREL · ReferenceDiscontinued
TRAZODONE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DESYREL · ReferenceDiscontinued
TRAZODONE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-04-14Labeling · Supplement 23 · standardAP
2000-04-14Labeling · Supplement 13AP
1996-06-25Manufacturing (CMC) · Supplement 26 · standardAP
1996-06-25Manufacturing (CMC) · Supplement 25 · standardAP
1996-06-21Manufacturing (CMC) · Supplement 27 · standardAP
1996-02-07Manufacturing (CMC) · Supplement 24 · standardAP
1990-03-05Manufacturing (CMC) · Supplement 20 · standardAP
1988-11-07Efficacy · Supplement 14AP
1988-10-26Manufacturing (CMC) · Supplement 19 · standardAP
1988-04-14Manufacturing (CMC) · Supplement 18 · standardAP
1988-01-22Manufacturing (CMC) · Supplement 17 · standardAP
1986-09-03Manufacturing (CMC) · Supplement 3 · standardAP
1986-09-03Manufacturing (CMC) · Supplement 15 · standardAP
1986-09-02Efficacy · Supplement 12AP
1986-02-26Manufacturing (CMC) · Supplement 11 · standardAP
1985-09-27Labeling · Supplement 7AP
1985-09-19Labeling · Supplement 10AP
1985-07-10Manufacturing (CMC) · Supplement 9 · standardAP
1985-03-25Manufacturing (CMC) · Supplement 4 · standardAP
1983-11-29Manufacturing (CMC) · Supplement 5 · standardAP
1983-10-24Labeling · Supplement 6AP
1983-04-04Manufacturing (CMC) · Supplement 2 · standardAP
1982-02-01Labeling · Supplement 1AP
1981-12-24Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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