FDA.reportPublic FDA data

Application 019847

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROCIPROFLOXACININJECTABLE;INJECTION400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CIPROCIPROFLOXACININJECTABLE;INJECTION200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003CIPROCIPROFLOXACININJECTABLE;INJECTION1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79940SUPPL 2024-10-21
79895SUPPL 2024-10-15
79893SUPPL 2024-10-15
70631SUPPL2022-03-28
70614SUPPL2022-03-28
70613SUPPL2022-03-28
62902SUPPL2020-05-11
62901SUPPL2020-05-11
62895SUPPL2020-05-11
62090SUPPL2020-03-09
62089SUPPL2020-03-09
62071SUPPL2020-03-06
58607SUPPL2019-05-07
58606SUPPL2019-05-07
58575SUPPL2019-05-06
56130SUPPL2018-10-29
56129SUPPL2018-10-29
56063SUPPL2018-10-23
49192SUPPL2017-08-02
49162SUPPL2017-07-31
34028SUPPL2016-07-26
1705SUPPL2016-07-26
11777SUPPL2015-03-20
1704SUPPL2015-03-20
11776SUPPL2015-03-02
1703SUPPL2015-02-12
19753SUPPL2013-08-16
34027SUPPL2013-08-15
34026SUPPL2013-02-01
1702SUPPL2013-01-31
19749SUPPL2011-11-21
34025SUPPL2011-11-16
11775SUPPL2011-11-04
19752SUPPL2011-10-20
11774SUPPL2011-08-16
19751SUPPL2011-08-15
1701SUPPL2011-08-08
43629ORIG2011-03-15
11773SUPPL2011-03-04
19750SUPPL2011-03-02
1700SUPPL2009-06-30
34024SUPPL2009-05-11
1699SUPPL2009-05-07
11772SUPPL2009-02-20
1698SUPPL2009-02-18
34023SUPPL2008-10-09
1697SUPPL2008-10-07
41059SUPPL2008-08-11
20392SUPPL2008-08-08
20394SUPPL2008-08-04
41061SUPPL2008-07-31
41060SUPPL2008-07-31
20396SUPPL2008-07-31
20395SUPPL2008-07-31
19748SUPPL2008-01-24
34022SUPPL2008-01-23
20397SUPPL2007-07-09
19747SUPPL2007-07-05
34021SUPPL2007-06-27
19746SUPPL2006-06-28
1696SUPPL2005-11-18
11771SUPPL2005-11-17
34020SUPPL2005-05-20
19745SUPPL2005-05-20
11770SUPPL2005-01-11
1695SUPPL2005-01-11
34019SUPPL2004-07-21
34018SUPPL2004-07-21
19744SUPPL2004-07-21
19743SUPPL2004-07-21
11769SUPPL2004-07-21
1694SUPPL2004-07-21
11768SUPPL2004-04-05
1693SUPPL2004-03-28
34017SUPPL2002-04-17
1692SUPPL2002-04-17
34016SUPPL2000-08-30
20393SUPPL2000-08-30
1691SUPPL2000-08-30