FDA.reportPublic FDA data

Application 020780

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROCIPROFLOXACINFOR SUSPENSION;ORAL250MG/5MLYesNo
002CIPROCIPROFLOXACINFOR SUSPENSION;ORAL500MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-773CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-777CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79727SUPPL 2024-09-24
79690SUPPL 2024-09-23
79689SUPPL 2024-09-23
66949SUPPL2021-04-01
66948SUPPL2021-04-01
66926SUPPL2021-03-31
62928SUPPL2020-05-12
62927SUPPL2020-05-12
62890SUPPL2020-05-11
62073SUPPL2020-03-06
62067SUPPL2020-03-06
62066SUPPL2020-03-06
58624SUPPL2019-05-08
58568SUPPL2019-05-06
56062SUPPL2018-10-23
56027SUPPL2018-10-19
49104SUPPL2017-07-28
49099SUPPL2017-07-27
45384SUPPL2016-09-20
45290SUPPL2016-09-19
35347SUPPL2016-07-26
25816SUPPL2016-07-26
13425SUPPL2015-03-02
25815SUPPL2015-02-12
3342SUPPL2013-08-16
13424SUPPL2013-08-15
13423SUPPL2013-02-01
3341SUPPL2013-01-31
25813SUPPL2011-11-21
13420SUPPL2011-11-16
13422SUPPL2011-11-04
3340SUPPL2011-10-20
25814SUPPL2011-08-08
13421SUPPL2011-06-14
3339SUPPL2011-06-14
35346SUPPL2011-03-04
3338SUPPL2011-03-02
25811SUPPL2009-06-30
13419SUPPL2009-05-11
3337SUPPL2009-05-07
35345SUPPL2009-04-16
25812SUPPL2009-04-10
35344SUPPL2009-02-20
25810SUPPL2009-02-18
13418SUPPL2008-10-09
25809SUPPL2008-10-07
41694SUPPL2008-08-08
41693SUPPL2008-08-08
20942SUPPL2008-08-08
20943SUPPL2008-08-01
41696SUPPL2008-07-31
20947SUPPL2008-07-31
20946SUPPL2008-07-31
35343SUPPL2008-01-23
3336SUPPL2008-01-22
41697SUPPL2007-11-19
20945SUPPL2007-11-19
20944SUPPL2007-11-19
20948SUPPL2007-07-09
25808SUPPL2007-07-05
13417SUPPL2007-06-27
3335SUPPL2006-06-28
3334SUPPL2005-11-18
35342SUPPL2005-11-17
35341SUPPL2005-05-20
25807SUPPL2005-05-20
25805SUPPL2005-01-11
13415SUPPL2005-01-11
35340SUPPL2004-07-21
25806SUPPL2004-07-21
13416SUPPL2004-07-21
3333SUPPL2004-07-21
35339SUPPL2004-04-05
13414SUPPL2004-04-05
13413SUPPL2004-04-05
13412SUPPL2004-04-05
25804SUPPL2004-03-28
25803SUPPL2004-03-28
25802SUPPL2004-03-28
25801SUPPL2004-03-28
25800SUPPL2002-04-17
13411SUPPL2002-04-17
41695SUPPL2000-08-30
35338SUPPL2000-08-30
25799SUPPL2000-08-30