FDA.reportPublic FDA data

Application 021277

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERMOXIFLOXACIN HYDROCHLORIDESOLUTION;INTRAVENOUS400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1737Aveloxmoxifloxacin hydrochlorideSchering Plough CorporationNDACurrent
50419-537Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-537Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-537Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-537Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82860SUPPL 2025-07-14
82859SUPPL 2025-07-14
82827SUPPL 2025-07-14
62850SUPPL2020-05-07
62849SUPPL2020-05-07
62843SUPPL2020-05-07
58621SUPPL2019-05-08
58620SUPPL2019-05-08
58573SUPPL2019-05-06
56067SUPPL2018-10-23
56034SUPPL2018-10-19
47513SUPPL2017-03-09
45488SUPPL2016-09-30
45435SUPPL2016-09-30
45434SUPPL2016-09-30
27340SUPPL2016-07-26
14850SUPPL2016-07-26
14849SUPPL2015-06-05
27339SUPPL2015-05-13
14848SUPPL2014-12-03
27338SUPPL2014-11-24
27337SUPPL2013-08-16
36550SUPPL2013-08-15
27336SUPPL2012-12-26
36549SUPPL2012-12-21
14847SUPPL2012-09-11
27335SUPPL2012-08-28
36548SUPPL2011-10-20
27334SUPPL2011-10-20
14846SUPPL2011-10-20
4873SUPPL2011-10-20
27333SUPPL2011-08-08
14845SUPPL2011-03-04
27332SUPPL2011-03-02
4872SUPPL2010-11-02
36547SUPPL2010-10-25
27331SUPPL2010-04-09
14844SUPPL2010-03-05
27330SUPPL2010-01-25
14843SUPPL2009-12-02
4871SUPPL2009-06-29
14842SUPPL2009-05-15
27329SUPPL2009-05-05
14841SUPPL2009-01-02
4869SUPPL2008-12-31
36546SUPPL2008-10-09
4870SUPPL2008-10-07
36545SUPPL2008-02-25
27328SUPPL2008-02-20
42071SUPPL2008-02-19
21568SUPPL2008-02-19
36544SUPPL2007-06-04
27327SUPPL2007-06-04
36543SUPPL2005-11-30
27326SUPPL2005-11-30
14840SUPPL2005-11-30
4868SUPPL2005-11-30
27325SUPPL2005-06-14
14839SUPPL2005-06-14
36542SUPPL2004-07-30
4867SUPPL2004-07-30
21567ORIG2004-05-27
14837SUPPL2004-05-27
4865SUPPL2004-05-26
14838SUPPL2004-04-05
4866SUPPL2004-03-10
36541SUPPL2003-10-10
27324SUPPL2003-10-06
27323SUPPL2003-03-10
27322SUPPL2003-03-10
4864SUPPL2003-03-10
36540SUPPL2003-02-28
36539SUPPL2003-02-28
14836SUPPL2003-02-28
27321SUPPL2002-06-12
14835SUPPL2002-06-12
27320SUPPL2002-05-22
36538SUPPL2002-05-16
4863SUPPL2002-05-16
14834ORIG2001-11-30
4862ORIG2001-11-30