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FDA NDA · NDA020711

ZYBAN

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020711
TYPE
NDA
ORIGINAL APPROVAL
1997-05-14
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ZYBAN · ReferenceDiscontinued
BUPROPION HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
ZYBANDiscontinued
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-07-13Labeling · Supplement 53 · standardAP
2021-03-09Labeling · Supplement 52 · standard — Letter ↗AP
2019-07-19Labeling · Supplement 48 · standard — Letter ↗AP
2017-05-04Labeling · Supplement 47 · standard — Label ↗AP
2017-05-04REMS · Supplement 45 — Label ↗AP
2017-05-04Labeling · Supplement 46 · standard — Label ↗AP
2016-06-01Labeling · Supplement 44 · standard — Letter ↗AP
2014-12-24Labeling · Supplement 42 · standard — Label ↗AP
2014-08-13Labeling · Supplement 43 · standard — Letter ↗AP
2014-03-27Labeling · Supplement 39 · standard — Label ↗AP
2012-01-18Labeling · Supplement 36 · standard — Letter ↗AP
2011-08-22Labeling · Supplement 35 · unknown — Letter ↗AP
2011-08-22Labeling · Supplement 26 · standard — Label ↗AP
2010-09-20Labeling · Supplement 31 · standard — Label ↗AP
2010-02-26Labeling · Supplement 34 · standard — Letter ↗AP
2009-07-01Labeling · Supplement 33 · 901 required — Label ↗AP
2009-07-01Labeling · Supplement 32 · standard — Label ↗AP
2007-08-02Labeling · Supplement 29 · standard — Label ↗AP
2007-03-22Labeling · Supplement 28 · standard — Label ↗AP
2006-11-16Labeling · Supplement 27 · standard — Label ↗AP
2006-04-28Labeling · Supplement 24 · standard — Letter ↗AP
2006-03-13Labeling · Supplement 22 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 21 · standard — Label ↗AP
2004-11-03Labeling · Supplement 20 · standard — Label ↗AP
2004-11-03Labeling · Supplement 19 · standard — Letter ↗AP
2003-02-14Labeling · Supplement 16 · standard — Label ↗AP
2003-02-14Labeling · Supplement 14 · standard — Label ↗AP
2003-02-14Labeling · Supplement 13 · standard — Letter ↗AP
2003-02-14Labeling · Supplement 18 · standard — Label ↗AP
2002-02-21Labeling · Supplement 15 · standard — Review ↗AP
2002-02-15Manufacturing (CMC) · Supplement 17 · standardAP
2001-02-07Efficacy · Supplement 12 · standard — Review ↗AP
2000-11-28Labeling · Supplement 8 · standardAP
2000-11-28Labeling · Supplement 10 · standardAP
2000-11-28Labeling · Supplement 9 · standardAP
2000-08-03Manufacturing (CMC) · Supplement 11 · standardAP
1999-09-10Efficacy · Supplement 3 · standardAP
1999-09-10Efficacy · Supplement 1 · standardAP
1999-04-07Manufacturing (CMC) · Supplement 6 · standardAP
1999-03-05Labeling · Supplement 7 · standardAP
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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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