FDA.reportPublic FDA data

Application 019857

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACININJECTABLE;INJECTION200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACININJECTABLE;INJECTION400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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
50419-759CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70612SUPPL2022-03-28
70611SUPPL2022-03-28
62892SUPPL2020-05-11
62891SUPPL2020-05-11
62888SUPPL2020-05-11
62092SUPPL2020-03-10
62091SUPPL2020-03-10
58609SUPPL2019-05-07
58605SUPPL2019-05-07
56064SUPPL2018-10-23
56037SUPPL2018-10-19
49425SUPPL2017-08-16
49424SUPPL2017-08-16
49107SUPPL2017-07-28
19777SUPPL2016-07-26
11795SUPPL2016-07-26
34052SUPPL2015-03-20
19776SUPPL2015-03-20
34051SUPPL2015-03-02
1729SUPPL2015-02-12
19775SUPPL2013-08-16
11794SUPPL2013-08-15
34050SUPPL2013-02-01
1728SUPPL2013-01-31
19771SUPPL2011-11-21
34048SUPPL2011-11-16
11793SUPPL2011-11-04
19774SUPPL2011-10-20
11792SUPPL2011-08-16
19773SUPPL2011-08-15
34049SUPPL2011-08-12
1727SUPPL2011-08-08
11791SUPPL2011-03-04
19772SUPPL2011-03-02
1726SUPPL2009-06-30
34047SUPPL2009-05-11
1725SUPPL2009-05-07
11790SUPPL2009-02-20
1724SUPPL2009-02-18
34046SUPPL2008-10-09
41063SUPPL2008-08-11
20399SUPPL2008-08-04
41068SUPPL2008-07-31
41067SUPPL2008-07-31
41066SUPPL2008-07-31
41065SUPPL2008-07-31
19770SUPPL2008-01-24
34045SUPPL2008-01-23
41069SUPPL2007-07-09
19769SUPPL2007-07-05
11789SUPPL2007-06-27
1723SUPPL2006-06-28
19768SUPPL2005-11-18
34044SUPPL2005-11-17
34043SUPPL2005-05-20
1722SUPPL2005-05-20
34042SUPPL2005-01-11
1720SUPPL2005-01-11
34041SUPPL2004-07-21
19767SUPPL2004-07-21
11788SUPPL2004-07-21
11787SUPPL2004-07-21
1721SUPPL2004-07-21
1719SUPPL2004-07-21
11786SUPPL2004-04-05
1718SUPPL2004-03-28
34040SUPPL2002-04-17
1717SUPPL2002-04-17
41064SUPPL2000-08-30
19766SUPPL2000-08-30
11785SUPPL2000-08-30