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FDA ANDA · ANDA071196

TRAZODONE HYDROCHLORIDE

Sponsor: APOTEX INC

APPLICATION
ANDA071196
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-25
LATEST ACTION
2026-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRAZODONE HYDROCHLORIDEPrescription
TRAZODONE HYDROCHLORIDE 150MG · TABLET · ORAL
TRAZODONE HYDROCHLORIDEPrescription
TRAZODONE HYDROCHLORIDE 300MG · TABLET · ORAL
TRAZODONE HYDROCHLORIDEPrescription
TRAZODONE HYDROCHLORIDE 100MG · TABLET · ORAL

Approval history

2026-02-09Labeling · Supplement 83 · standardAP
2025-06-24Labeling · Supplement 82 · standardAP
2023-03-22Labeling · Supplement 76 · standardAP
2020-04-20Labeling · Supplement 70 · standardAP
2020-04-20Labeling · Supplement 73 · standardAP
2015-06-02Labeling · Supplement 62 · standard — Label ↗AP
2014-09-11Labeling · Supplement 64 · standardAP
2013-11-19Labeling · Supplement 63 · standard — Label ↗AP
2008-08-11Labeling · Supplement 54AP
2007-06-25Labeling · Supplement 50AP
2005-12-05Labeling · Supplement 48AP
2005-09-09Labeling · Supplement 47AP
2005-04-08Labeling · Supplement 46AP
2003-01-21Labeling · Supplement 44AP
2000-09-13Labeling · Supplement 42AP
2000-07-07Manufacturing (CMC) · Supplement 39AP
1999-12-21Manufacturing (CMC) · Supplement 40AP
1999-10-25Manufacturing (CMC) · Supplement 41AP
1999-10-25Manufacturing (CMC) · Supplement 37AP
1999-05-26Manufacturing (CMC) · Supplement 38AP
1999-05-26Manufacturing (CMC) · Supplement 36AP
1999-04-26Manufacturing (CMC) · Supplement 27AP
1999-04-26Manufacturing (CMC) · Supplement 19AP
1999-04-26Labeling · Supplement 25AP
1999-04-26Manufacturing (CMC) · Supplement 23AP
1999-04-26Manufacturing (CMC) · Supplement 21AP
1999-04-26Labeling · Supplement 26AP
1999-04-26Manufacturing (CMC) · Supplement 18AP
1999-04-26Manufacturing (CMC) · Supplement 24AP
1999-04-26Manufacturing (CMC) · Supplement 22AP
1999-04-26Manufacturing (CMC) · Supplement 20AP
1998-12-01Manufacturing (CMC) · Supplement 35AP
1998-09-25Manufacturing (CMC) · Supplement 34AP
1997-05-06Manufacturing (CMC) · Supplement 15AP
1996-09-18Labeling · Supplement 14AP
1994-12-23Manufacturing (CMC) · Supplement 13AP
1994-10-11Manufacturing (CMC) · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1991-09-23Labeling · Supplement 8AP
VIEW ON DRUGS@FDA ↗

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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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