FDA.reportPublic FDA data

Application 021085

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVELOXMOXIFLOXACIN HYDROCHLORIDETABLET;ORALEQ 400MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1733Aveloxmoxifloxacin hydrochlorideSchering Plough CorporationNDACurrent
43063-580Moxifloxacin Hydrochloridemoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-580Moxifloxacin Hydrochloridemoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-580Moxifloxacin Hydrochloridemoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-585Moxifloxacin Hydrochloridemoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
47781-268Moxifloxacin Hydrochloridemoxifloxacin hydrochlorideAlvogen, Inc.NDA AUTHORIZED GENERICCurrent
50419-530Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-530Aveloxmoxifloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
67296-0154Aveloxmoxifloxacin hydrochlorideRedPharm Drug Inc.NDACurrent
67296-1299Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
67296-1299Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82858SUPPL 2025-07-14
82857SUPPL 2025-07-14
82826SUPPL 2025-07-14
62848SUPPL2020-05-07
62844SUPPL2020-05-07
62847SUPPL2020-05-06
58619SUPPL2019-05-08
58618SUPPL2019-05-08
58571SUPPL2019-05-06
56066SUPPL2018-10-23
56033SUPPL2018-10-19
45433SUPPL2016-09-30
45432SUPPL2016-09-30
45431SUPPL2016-09-30
45430SUPPL2016-09-30
26716SUPPL2016-07-26
14348SUPPL2016-07-26
36079SUPPL2015-06-05
26715SUPPL2015-05-13
36078SUPPL2014-12-03
26714SUPPL2014-11-24
26713SUPPL2013-08-16
14347SUPPL2013-08-15
26712SUPPL2012-12-26
36077SUPPL2012-12-21
36076SUPPL2012-09-11
4282SUPPL2012-08-28
26711SUPPL2011-10-20
14346SUPPL2011-10-20
14345SUPPL2011-10-20
4281SUPPL2011-10-20
26710SUPPL2011-08-08
36075SUPPL2011-03-04
4280SUPPL2011-03-02
4278SUPPL2010-11-02
14343SUPPL2010-10-25
4279SUPPL2010-04-09
36074SUPPL2010-03-05
26709SUPPL2010-01-25
14344SUPPL2009-12-02
4277SUPPL2009-06-29
14342SUPPL2009-05-15
26708SUPPL2009-05-05
36072SUPPL2009-01-02
26707SUPPL2008-12-31
36073SUPPL2008-10-09
4276SUPPL2008-10-07
14341SUPPL2008-02-25
4275SUPPL2008-02-20
21432SUPPL2008-02-19
36071SUPPL2007-06-04
4274SUPPL2007-06-04
14340SUPPL2005-11-30
14339SUPPL2005-11-30
4273SUPPL2005-11-30
4272SUPPL2005-11-30
36070SUPPL2005-06-14
4271SUPPL2005-06-14
14338SUPPL2004-07-30
4270SUPPL2004-07-30
41939ORIG2004-05-27
21431SUPPL2004-05-27
14336SUPPL2004-05-27
4268SUPPL2004-05-26
14337SUPPL2004-04-05
4269SUPPL2004-03-10
36069SUPPL2003-10-10
26706SUPPL2003-10-06
26705SUPPL2003-03-10
26704SUPPL2003-03-10
4267SUPPL2003-03-10
36068SUPPL2003-02-28
36067SUPPL2003-02-28
14335SUPPL2003-02-28
36064SUPPL2002-06-12
36063SUPPL2002-06-12
26701SUPPL2002-06-12
4266SUPPL2002-06-12
36066SUPPL2002-05-16
26703SUPPL2002-05-16
36065SUPPL2001-04-27
26702SUPPL2001-04-27
36062ORIG1999-12-10
26700ORIG1999-12-10
51387ORIG1900-01-01
51386ORIG1900-01-01
51385ORIG1900-01-01