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FDA NDA · NDA050775

BIAXIN XL

Sponsor: ABBVIE

APPLICATION
NDA050775
TYPE
NDA
ORIGINAL APPROVAL
2000-03-03
LATEST ACTION
2019-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

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CLARITHROMYCIN 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-09-18Labeling · Supplement 29 · standard — Label ↗AP
2018-12-19Labeling · Supplement 28 · standard — Label ↗AP
2018-11-25Labeling · Supplement 27 · standard — Label ↗AP
2017-06-09Labeling · Supplement 26 · standard — Label ↗AP
2016-05-26Labeling · Supplement 22 · standard — Label ↗AP
2015-10-23Labeling · Supplement 25 · standard — Label ↗AP
2015-01-08Labeling · Supplement 24 · standard — Label ↗AP
2014-07-25Labeling · Supplement 23 · standard — Letter ↗AP
2013-09-09Labeling · Supplement 20 · standard — Letter ↗AP
2013-09-09Labeling · Supplement 21 · standard — Letter ↗AP
2012-07-05Labeling · Supplement 18 · standard — Label ↗AP
2012-06-01Labeling · Supplement 17 · standard — Letter ↗AP
2012-05-03Labeling · Supplement 19 · standard — Label ↗AP
2012-05-03Labeling · Supplement 15 · standard — Letter ↗AP
2011-05-27Labeling · Supplement 16 · standard — Label ↗AP
2011-05-27Labeling · Supplement 14 · standard — Letter ↗AP
2009-08-14Labeling · Supplement 13 · standard — Letter ↗AP
2008-12-04Labeling · Supplement 37 · standardAP
2008-05-22Labeling · Supplement 12 · standard — Letter ↗AP
2007-12-18Labeling · Supplement 11 · standard — Label ↗AP
2006-07-05Labeling · Supplement 9 · standard — Letter ↗AP
2005-10-04Labeling · Supplement 8 · standard — Label ↗AP
2004-07-19Labeling · Supplement 7 · standard — Letter ↗AP
2003-04-11Labeling · Supplement 4 · standard — Letter ↗AP
2002-12-20Manufacturing (CMC) · Supplement 5 · standardAP
2002-03-15Labeling · Supplement 2 · standardAP
2001-11-16Manufacturing (CMC) · Supplement 3 · standardAP
2001-08-02Efficacy · Supplement 1 · standard — Label ↗AP
2000-03-03Type 3 - New Dosage Form · Original · standard — Label ↗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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