← FDA DRUG APPROVALS

FDA NDA · NDA021085

AVELOX

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021085
TYPE
NDA
ORIGINAL APPROVAL
1999-12-10
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AVELOX · ReferenceDiscontinued
MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-07-11Labeling · Supplement 69 · standard — Letter ↗AP
2020-05-06Labeling · Supplement 66 · standard — Letter ↗AP
2019-05-03Labeling · Supplement 65 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 64 · standard — Label ↗AP
2016-09-27Labeling · Supplement 62 · standard — Label ↗AP
2016-09-27Efficacy · Supplement 61 · priority — Label ↗AP
2016-07-26Labeling · Supplement 63 · standard — Label ↗AP
2015-05-08Efficacy · Supplement 60 · standard — Label ↗AP
2014-11-20Labeling · Supplement 59 · standard — Letter ↗AP
2014-11-19Manufacturing (CMC) · Supplement 58 · standardAP
2013-08-14Labeling · Supplement 57 · 901 required — Label ↗AP
2012-12-18Labeling · Supplement 56 · standard — Letter ↗AP
2012-08-24Labeling · Supplement 55 · standard — Letter ↗AP
2011-10-18Labeling · Supplement 50 · standard — Letter ↗AP
2011-10-18Labeling · Supplement 53 · unknown — Label ↗AP
2011-08-03REMS · Supplement 52 — Letter ↗AP
2011-02-25Labeling · Supplement 47 · 901 required — Letter ↗AP
2010-10-25Labeling · Supplement 44 · standard — Letter ↗AP
2010-03-02Labeling · Supplement 46 · unknown — Label ↗AP
2009-11-24Labeling · Supplement 45 · unknown — Label ↗AP
2009-06-24Labeling · Supplement 41 · standard — Letter ↗AP
2009-04-27Labeling · Supplement 42 · standard — Label ↗AP
2008-12-29Labeling · Supplement 39 · standard — Letter ↗AP
2008-10-03Labeling · Supplement 40 · standard — Label ↗AP
2008-02-15Labeling · Supplement 38 · standard — Letter ↗AP
2007-05-31Labeling · Supplement 36 · standard — Letter ↗AP
2005-11-22Efficacy · Supplement 27 · unknown — Letter ↗AP
2005-11-22Labeling · Supplement 29 · standard — Letter ↗AP
2005-06-13Efficacy · Supplement 26 · unknown — Label ↗AP
2004-12-14Manufacturing (CMC) · Supplement 25 · standardAP
2004-07-28Labeling · Supplement 24 · standard — Letter ↗AP
2004-05-18Efficacy · Supplement 22 · priority — Letter ↗AP
2004-03-06Labeling · Supplement 23 · standard — Letter ↗AP
2003-10-06Labeling · Supplement 19 · standard — Label ↗AP
2003-02-28Labeling · Supplement 17 · standard — Letter ↗AP
2003-02-28Efficacy · Supplement 15 · standard — Letter ↗AP
2003-02-28Labeling · Supplement 14 · standard — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 13 · standardAP
2002-06-12Labeling · Supplement 7 · standard — Label ↗AP
2002-06-12Labeling · Supplement 6 · standard — Letter ↗AP
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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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