FDA.reportPublic FDA data

Application 021473

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPRO XRCIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002CIPRO XRCIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-788CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-789CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66951SUPPL2021-04-01
66950SUPPL2021-04-01
66928SUPPL2021-03-31
62906SUPPL2020-05-11
62905SUPPL2020-05-11
62886SUPPL2020-05-11
62084SUPPL2020-03-09
62063SUPPL2020-03-06
62062SUPPL2020-03-06
58626SUPPL2019-05-08
58595SUPPL2019-05-07
56070SUPPL2018-10-23
56024SUPPL2018-10-19
49109SUPPL2017-07-28
49089SUPPL2017-07-27
15554SUPPL2016-07-26
5479SUPPL2016-07-26
24001ORIG2016-02-03
37026SUPPL2015-02-03
27893SUPPL2015-02-02
27892SUPPL2013-08-16
15553SUPPL2013-08-15
37025SUPPL2013-02-01
5478SUPPL2013-01-31
5476SUPPL2011-11-21
15552SUPPL2011-11-16
37024SUPPL2011-11-04
27891SUPPL2011-10-20
5477SUPPL2011-08-08
27890SUPPL2011-06-15
37023SUPPL2011-06-14
37022SUPPL2011-03-04
27889SUPPL2011-03-02
27888SUPPL2009-06-30
15551SUPPL2009-05-11
5475SUPPL2009-05-07
15550SUPPL2008-10-09
5474SUPPL2008-10-07
37021SUPPL2008-01-23
5473SUPPL2008-01-23
42186SUPPL2007-07-09
21681SUPPL2007-07-09
21680SUPPL2007-07-09
21679SUPPL2007-07-09
21678SUPPL2007-07-09
5472SUPPL2007-07-05
37020SUPPL2007-06-27
27887SUPPL2005-11-18
37019SUPPL2005-11-17
37018SUPPL2005-05-20
27886SUPPL2005-05-20
37017SUPPL2004-07-21
37016SUPPL2004-07-21
27885SUPPL2004-07-21
27884SUPPL2004-07-21
15549SUPPL2004-07-21
5471SUPPL2004-07-21
42185ORIG2003-11-06
15548ORIG2002-12-16
5470ORIG2002-12-13