FDA.reportPublic FDA data

Application 019537

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROCIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CIPROCIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 250MG BASEYesNo
003CIPROCIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 500MG BASEYesYes
004CIPROCIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-754Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-758Ciprociprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79713SUPPL 2024-09-24
79688SUPPL 2024-09-23
79687SUPPL 2024-09-23
69306SUPPL2021-11-12
69305SUPPL2021-11-12
69293SUPPL2021-11-12
66947SUPPL2021-04-01
66946SUPPL2021-04-01
66925SUPPL2021-03-31
62926SUPPL2020-05-12
62924SUPPL2020-05-12
62889SUPPL2020-05-11
62072SUPPL2020-03-06
62065SUPPL2020-03-06
62064SUPPL2020-03-06
58622SUPPL2019-05-08
58567SUPPL2019-05-06
58566SUPPL2019-05-06
56061SUPPL2018-10-23
56026SUPPL2018-10-19
49103SUPPL2017-07-28
49097SUPPL2017-07-27
45385SUPPL2016-09-19
45289SUPPL2016-09-19
33791SUPPL2016-07-26
17446SUPPL2016-07-26
33790SUPPL2015-03-02
1377SUPPL2015-02-12
1376SUPPL2013-08-16
11527SUPPL2013-08-15
11526SUPPL2013-02-01
17445SUPPL2013-01-31
40934SUPPL2012-09-17
20258SUPPL2012-09-17
1374SUPPL2011-11-21
33787SUPPL2011-11-16
33789SUPPL2011-11-04
17444SUPPL2011-10-20
1375SUPPL2011-08-08
33788SUPPL2011-06-14
17443SUPPL2011-06-14
11525SUPPL2011-03-04
17442SUPPL2011-03-02
1373SUPPL2009-06-30
33785SUPPL2009-05-11
17440SUPPL2009-05-07
33786SUPPL2009-04-16
17441SUPPL2009-04-10
11524SUPPL2009-02-20
1372SUPPL2009-02-18
11523SUPPL2008-10-09
1371SUPPL2008-10-07
40922SUPPL2008-08-11
40920SUPPL2008-08-11
20254SUPPL2008-08-11
40933SUPPL2008-04-04
40932SUPPL2008-04-04
40929SUPPL2008-04-04
40927SUPPL2008-04-04
40924SUPPL2008-04-04
40919SUPPL2008-04-04
20256SUPPL2008-04-04
11522SUPPL2008-01-23
17439SUPPL2008-01-22
40931SUPPL2007-11-19
40930SUPPL2007-11-19
40928SUPPL2007-11-19
40926SUPPL2007-11-19
40925SUPPL2007-07-09
40921SUPPL2007-07-09
20257SUPPL2007-07-09
20255SUPPL2007-07-09
17438SUPPL2007-07-05
11521SUPPL2007-06-27
17437SUPPL2006-06-28
1370SUPPL2005-11-18
33784SUPPL2005-11-17
33783SUPPL2005-05-20
17436SUPPL2005-05-20
33781SUPPL2005-01-11
17434SUPPL2005-01-11
40918SUPPL2004-10-08
40917SUPPL2004-09-29
33782SUPPL2004-07-21
17435SUPPL2004-07-21
11520SUPPL2004-07-21
1369SUPPL2004-07-21
33780SUPPL2004-04-05
33779SUPPL2004-04-05
33778SUPPL2004-04-05
11519SUPPL2004-04-05
17433SUPPL2004-03-28
1368SUPPL2004-03-28
1367SUPPL2004-03-28
1366SUPPL2004-03-28
17432SUPPL2002-12-16
17431SUPPL2002-04-17
11518SUPPL2002-04-17
40923SUPPL2000-08-30
33777SUPPL2000-08-30