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FDA NDA · NDA050662

BIAXIN

Sponsor: ABBVIE

APPLICATION
NDA050662
TYPE
NDA
ORIGINAL APPROVAL
1991-10-31
LATEST ACTION
2019-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BIAXIN · ReferenceDiscontinued
CLARITHROMYCIN 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
BIAXIN · ReferenceDiscontinued
CLARITHROMYCIN 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-09-18Labeling · Supplement 61 · standard — Label ↗AP
2018-12-19Labeling · Supplement 60 · standard — Label ↗AP
2018-11-25Labeling · Supplement 59 · standard — Label ↗AP
2017-06-09Labeling · Supplement 58 · standard — Label ↗AP
2016-05-26Labeling · Supplement 54 · standard — Label ↗AP
2015-10-23Labeling · Supplement 57 · standard — Label ↗AP
2015-01-08Labeling · Supplement 56 · standard — Letter ↗AP
2014-07-25Labeling · Supplement 55 · standard — Label ↗AP
2013-09-09Labeling · Supplement 52 · standard — Label ↗AP
2013-09-09Labeling · Supplement 53 · standard — Letter ↗AP
2012-11-23Manufacturing (CMC) · Supplement 49 · priorityAP
2012-07-05Labeling · Supplement 48 · standard — Label ↗AP
2012-06-01Labeling · Supplement 46 · standard — Letter ↗AP
2012-05-03Labeling · Supplement 44 · standard — Letter ↗AP
2012-05-03Labeling · Supplement 50 · standard — Label ↗AP
2011-05-27Labeling · Supplement 45 · unknown — Letter ↗AP
2011-05-27Labeling · Supplement 43 · standard — Label ↗AP
2009-08-14Labeling · Supplement 42 · standard — Label ↗AP
2008-05-22Labeling · Supplement 41 · standard — Letter ↗AP
2007-12-18Labeling · Supplement 40 · standard — Label ↗AP
2006-07-05Labeling · Supplement 39 · standard — Letter ↗AP
2005-10-04Labeling · Supplement 38 · standard — Label ↗AP
2004-07-19Labeling · Supplement 36 · standard — Letter ↗AP
2002-11-08Manufacturing (CMC) · Supplement 33 · priorityAP
2002-06-06Manufacturing (CMC) · Supplement 32 · priorityAP
2002-06-06Labeling · Supplement 30 · standard — Letter ↗AP
2002-06-06Labeling · Supplement 31 · standard — Review ↗AP
2000-10-20Efficacy · Supplement 29 · standard — Review ↗AP
2000-03-20Labeling · Supplement 28 · standard — Review ↗AP
1999-10-22Manufacturing (CMC) · Supplement 25 · priorityAP
1999-07-29Labeling · Supplement 26 · standardAP
1999-05-04Manufacturing (CMC) · Supplement 27 · priorityAP
1998-11-10Labeling · Supplement 24 · standardAP
1998-09-16Efficacy · Supplement 20 · standardAP
1998-07-21Labeling · Supplement 22 · standardAP
1998-04-27Manufacturing (CMC) · Supplement 23 · priorityAP
1998-01-05Manufacturing (CMC) · Supplement 21 · priorityAP
1997-09-16Labeling · Supplement 18 · standardAP
1997-09-16Efficacy · Supplement 19 · standardAP
1997-08-26Labeling · Supplement 12 · 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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