FDA.reportPublic FDA data

Application 020635

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVAQUINLEVOFLOXACININJECTABLE;INJECTIONEQ 500MG/20ML (EQ 25MG/ML)YesNo
002LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004LEVAQUINLEVOFLOXACININJECTABLE;INJECTIONEQ 750MG/30ML (EQ 25MG/ML)YesNo
005LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACININJECTABLE;INJECTIONEQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47162SUPPL2017-02-10
47150SUPPL2017-02-09
35039SUPPL2016-07-26
2959SUPPL2016-07-26
41511SUPPL2015-03-11
35038SUPPL2014-05-28
25402SUPPL2014-05-28
2958SUPPL2013-08-16
35037SUPPL2013-08-15
41512SUPPL2012-06-22
20791SUPPL2012-06-22
25399SUPPL2012-05-01
35035SUPPL2012-04-30
25401SUPPL2011-10-13
25400SUPPL2011-10-13
35036SUPPL2011-10-12
12901SUPPL2011-10-12
35034SUPPL2011-06-14
2957SUPPL2011-06-14
35033SUPPL2011-03-04
2956SUPPL2011-03-03
23172ORIG2009-11-19
35032SUPPL2009-05-11
25398SUPPL2009-05-05
2955SUPPL2009-03-13
12900SUPPL2008-10-08
25397SUPPL2008-10-07
41510SUPPL2008-08-01
41509SUPPL2008-08-01
24178SUPPL2008-07-16
12899SUPPL2008-06-05
2952SUPPL2008-05-08
25396SUPPL2008-04-18
2954SUPPL2008-01-09
12898SUPPL2007-12-14
35031SUPPL2007-11-19
35030SUPPL2007-11-19
25395SUPPL2007-11-19
2953SUPPL2007-11-19
2951SUPPL2007-09-25
2950SUPPL2007-09-25
35028SUPPL2007-09-19
35026SUPPL2007-09-19
25394SUPPL2007-07-05
35029SUPPL2007-06-27
35027SUPPL2007-06-04
25392SUPPL2007-06-04
25393SUPPL2007-05-16
12897SUPPL2007-05-16
12896SUPPL2006-06-28
2949SUPPL2006-06-28
12895SUPPL2006-01-27
35025SUPPL2005-08-08
25391SUPPL2005-08-08
20790SUPPL2005-06-27
20789SUPPL2005-06-27
20788SUPPL2005-06-27
35023SUPPL2004-12-03
25390SUPPL2004-12-02
35024SUPPL2004-11-08
2948SUPPL2004-11-08
12894SUPPL2004-09-15
12893SUPPL2004-09-15
2947SUPPL2004-09-15
2946SUPPL2004-09-15
41508SUPPL2004-09-09
20787SUPPL2004-09-09
2945SUPPL2004-07-21
35018SUPPL2004-06-08
12892SUPPL2004-04-05
25389SUPPL2004-03-10
2944SUPPL2003-12-04
35022SUPPL2003-06-08
2943SUPPL2003-06-08
2942SUPPL2002-10-30
35021SUPPL2001-12-18
35020SUPPL2001-12-18
35019SUPPL2001-12-18
25388SUPPL2001-12-18
25387SUPPL2001-12-18
25386SUPPL2001-12-18
25385SUPPL2000-09-08
12891SUPPL2000-09-08
25384SUPPL2000-02-02
20786SUPPL1999-07-02
2941SUPPL1998-12-17
20785ORIG1997-12-11
66975SUPPL1900-01-01
66974SUPPL1900-01-01
52016SUPPL1900-01-01
52015SUPPL1900-01-01
52010SUPPL1900-01-01
52007SUPPL1900-01-01
52004SUPPL1900-01-01