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FDA NDA · NDA020152

SERZONE

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA020152
TYPE
NDA
ORIGINAL APPROVAL
1994-12-22
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SERZONE · ReferenceDiscontinued
NEFAZODONE HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SERZONE · ReferenceDiscontinued
NEFAZODONE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SERZONE · ReferenceDiscontinued
NEFAZODONE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SERZONE · ReferenceDiscontinued
NEFAZODONE HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SERZONE · ReferenceDiscontinued
NEFAZODONE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SERZONE · ReferenceDiscontinued
NEFAZODONE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2009-03-13Labeling · Supplement 14 · standardAP
2009-03-13Efficacy · Supplement 32 · priorityAP
2005-01-12Labeling · Supplement 35 · standard — Label ↗AP
2004-05-27Labeling · Supplement 34 · standard — Letter ↗AP
2003-05-05Labeling · Supplement 31 · standard — Letter ↗AP
2002-06-20Labeling · Supplement 33 · standard — Letter ↗AP
2002-04-23Manufacturing (CMC) · Supplement 30 · standardAP
2002-03-11Manufacturing (CMC) · Supplement 27 · standardAP
2002-01-08Labeling · Supplement 29 · standard — Letter ↗AP
2001-12-04Labeling · Supplement 28 · standard — Letter ↗AP
2001-03-21Labeling · Supplement 26 · standard — Review ↗AP
2001-01-23Labeling · Supplement 25 · standardAP
2000-11-09Manufacturing (CMC) · Supplement 24 · standardAP
2000-07-26Labeling · Supplement 6 · standard — Review ↗AP
2000-06-01Labeling · Supplement 16 · standardAP
2000-06-01Labeling · Supplement 19 · standardAP
2000-06-01Labeling · Supplement 17 · standardAP
2000-06-01Labeling · Supplement 23 · standardAP
2000-06-01Labeling · Supplement 15 · standardAP
2000-04-10Manufacturing (CMC) · Supplement 22 · standardAP
1999-11-30Manufacturing (CMC) · Supplement 21 · standardAP
1999-09-23Manufacturing (CMC) · Supplement 18 · standardAP
1999-09-09Labeling · Supplement 20 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 13 · standardAP
1998-03-31Labeling · Supplement 11 · standard — Letter ↗AP
1997-08-06Labeling · Supplement 12 · standardAP
1997-05-05Labeling · Supplement 9 · standard — Review ↗AP
1997-05-05Labeling · Supplement 10 · standard — Review ↗AP
1997-02-06Manufacturing (CMC) · Supplement 5 · standardAP
1997-01-13Manufacturing (CMC) · Supplement 7 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 8 · standardAP
1996-06-25Labeling · Supplement 3 · standardAP
1996-03-28Manufacturing (CMC) · Supplement 1 · standardAP
1996-03-28Manufacturing (CMC) · Supplement 4 · standardAP
1996-03-20Manufacturing (CMC) · Supplement 2 · standardAP
1994-12-22Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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