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FDA NDA · NDA021277

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021277
TYPE
NDA
ORIGINAL APPROVAL
2001-11-30
LATEST ACTION
2025-07-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER · ReferenceDiscontinued
MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2025-07-11Labeling · Supplement 65 · standard — Letter ↗AP
2020-05-06Labeling · Supplement 62 · standard — Letter ↗AP
2019-05-03Labeling · Supplement 61 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 60 · standard — Label ↗AP
2016-09-27Efficacy · Supplement 57 · priority — Letter ↗AP
2016-09-27Labeling · Supplement 58 · standard — Letter ↗AP
2016-07-26Labeling · Supplement 59 · standard — Label ↗AP
2015-05-08Efficacy · Supplement 56 · standard — Label ↗AP
2014-11-20Labeling · Supplement 55 · standard — Label ↗AP
2013-08-14Labeling · Supplement 54 · 901 required — Letter ↗AP
2012-12-18Labeling · Supplement 53 · standard — Label ↗AP
2012-08-24Labeling · Supplement 52 · standard — Label ↗AP
2011-10-18Labeling · Supplement 46 · unknown — Letter ↗AP
2011-10-18Labeling · Supplement 50 · unknown — Label ↗AP
2011-08-03REMS · Supplement 49 — Letter ↗AP
2011-02-25Labeling · Supplement 41 · 901 required — Label ↗AP
2010-10-25Labeling · Supplement 38 · standard — Letter ↗AP
2010-03-02Labeling · Supplement 40 · unknown — Label ↗AP
2009-11-24Labeling · Supplement 39 · unknown — Label ↗AP
2009-06-24Labeling · Supplement 35 · standard — Letter ↗AP
2009-04-27Labeling · Supplement 36 · standard — Label ↗AP
2008-12-29Labeling · Supplement 33 · standard — Letter ↗AP
2008-10-03Labeling · Supplement 34 · standard — Letter ↗AP
2008-02-15Labeling · Supplement 31 · standard — Letter ↗AP
2007-05-31Labeling · Supplement 30 · standard — Label ↗AP
2005-11-22Efficacy · Supplement 24 · unknown — Letter ↗AP
2005-11-22Labeling · Supplement 25 · standard — Letter ↗AP
2005-06-13Efficacy · Supplement 22 · standard — Label ↗AP
2004-07-28Labeling · Supplement 19 · standard — Letter ↗AP
2004-05-18Efficacy · Supplement 17 · priority — Letter ↗AP
2004-03-06Labeling · Supplement 18 · standard — Letter ↗AP
2003-10-06Labeling · Supplement 11 · standard — Letter ↗AP
2003-02-28Labeling · Supplement 6 · standard — Letter ↗AP
2003-02-28Labeling · Supplement 9 · standard — Label ↗AP
2003-02-28Efficacy · Supplement 7 · standard — Review ↗AP
2002-12-10Manufacturing (CMC) · Supplement 5 · standardAP
2002-06-12Labeling · Supplement 2 · standard — Label ↗AP
2002-05-22Labeling · Supplement 1 · standard — Letter ↗AP
2002-05-16Labeling · Supplement 3 · standard — Label ↗AP
2001-11-30Type 3 - New Dosage Form · Original · standard — Letter ↗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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