FDA.reportPublic FDA data

Application 021721

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVAQUINLEVOFLOXACINSOLUTION;ORAL250MG/10MLYesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47161SUPPL2017-02-10
47151SUPPL2017-02-09
37534SUPPL2016-07-26
6057SUPPL2016-07-26
24212SUPPL2015-03-10
21790SUPPL2015-03-10
37533SUPPL2014-05-28
28470SUPPL2014-05-28
6056SUPPL2013-08-16
37532SUPPL2013-08-15
42284SUPPL2012-06-22
21791SUPPL2012-06-22
28467SUPPL2012-05-01
37530SUPPL2012-04-30
28469SUPPL2011-10-13
28468SUPPL2011-10-13
37531SUPPL2011-10-12
16261SUPPL2011-10-12
37529SUPPL2011-06-14
28466SUPPL2011-06-14
37528SUPPL2011-03-04
6055SUPPL2011-03-03
43772ORIG2009-11-19
37527SUPPL2009-05-11
6054SUPPL2009-05-05
28465SUPPL2009-03-13
37526SUPPL2008-10-08
28464SUPPL2008-10-07
24211SUPPL2008-07-16
16260SUPPL2008-06-05
28461SUPPL2008-05-08
28463SUPPL2008-04-18
28462SUPPL2008-01-09
37525SUPPL2007-12-14
37524SUPPL2007-11-19
16259SUPPL2007-11-19
6053SUPPL2007-11-19
6052SUPPL2007-11-19
28460SUPPL2007-09-25
28459SUPPL2007-09-25
37521SUPPL2007-09-19
16258SUPPL2007-09-19
6051SUPPL2007-07-05
37523SUPPL2007-06-27
16257SUPPL2007-06-04
6049SUPPL2007-06-04
37522SUPPL2007-05-16
6050SUPPL2007-05-16
21789ORIG2007-04-20
37520SUPPL2006-06-28
6048SUPPL2006-06-28
28458SUPPL2006-01-30
37519SUPPL2006-01-27
37517SUPPL2005-08-08
28457SUPPL2005-08-08
37518SUPPL2004-12-03
6047SUPPL2004-12-02
16256ORIG2004-11-01
6046ORIG2004-10-29
52018SUPPL1900-01-01
52013SUPPL1900-01-01
52012SUPPL1900-01-01
52006SUPPL1900-01-01
52005SUPPL1900-01-01