FDA.reportPublic FDA data

Application 020634

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVAQUINLEVOFLOXACINTABLET;ORAL250MGYesNo
002LEVAQUINLEVOFLOXACINTABLET;ORAL500MGYesNo
003LEVAQUINLEVOFLOXACINTABLET;ORAL750MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-464LEVAQUINlevofloxacinRebel Distributors CorpNDACurrent
21695-519LEVAQUINlevofloxacinRebel Distributors CorpNDACurrent
43063-113LevaquinlevofloxacinPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-113LevaquinlevofloxacinPD-Rx Pharmaceuticals, Inc.NDACurrent
50458-920LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-920LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-920LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-925LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
50458-930LevaquinlevofloxacinJanssen Pharmaceuticals, Inc.NDACurrent
55289-394LevaquinlevofloxacinPD-Rx Pharmaceuticals, InNDACurrent
55289-394LevaquinlevofloxacinPD-Rx Pharmaceuticals, Inc.NDACurrent
67296-0372LEVAQUINlevofloxacinRedPharm Drug Inc.NDACurrent
67296-0584LEVAQUINlevofloxacinRedPharm Drug Inc.NDACurrent
67296-0586LEVAQUINlevofloxacinRedPharm Drug Inc.NDACurrent
70518-0501LevaquinlevofloxacinREMEDYREPACK INC.NDACurrent
70518-0501LevaquinlevofloxacinREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63784SUPPL2020-07-02
63783SUPPL2020-07-02
63678SUPPL2020-06-24
59225SUPPL2019-07-02
59224SUPPL2019-07-02
59201SUPPL2019-07-01
58632SUPPL2019-05-08
58574SUPPL2019-05-06
56065SUPPL2018-10-23
56031SUPPL2018-10-19
56030SUPPL2018-10-19
54820SUPPL2018-07-06
54741SUPPL2018-07-03
54740SUPPL2018-07-03
47163SUPPL2017-02-10
47149SUPPL2017-02-09
25383SUPPL2016-07-26
12890SUPPL2016-07-26
41505SUPPL2015-03-11
35017SUPPL2014-05-28
25382SUPPL2014-05-28
25381SUPPL2013-08-16
12889SUPPL2013-08-15
41507SUPPL2012-06-22
41506SUPPL2012-06-22
25379SUPPL2012-05-01
35016SUPPL2012-04-30
25380SUPPL2011-10-13
2940SUPPL2011-10-13
12888SUPPL2011-10-12
12887SUPPL2011-10-12
35015SUPPL2011-06-14
25378SUPPL2011-06-14
12886SUPPL2011-03-04
2939SUPPL2011-03-03
41504SUPPL2009-09-17
41503SUPPL2009-09-17
35014SUPPL2009-05-11
2938SUPPL2009-05-05
25377SUPPL2009-03-13
35013SUPPL2008-10-08
25376SUPPL2008-10-07
41502SUPPL2008-08-01
20784SUPPL2008-08-01
24177SUPPL2008-07-16
12885SUPPL2008-06-05
25374SUPPL2008-05-08
25375SUPPL2008-04-18
2937SUPPL2008-01-09
12884SUPPL2007-12-14
35012SUPPL2007-11-19
12883SUPPL2007-11-19
2936SUPPL2007-11-19
2935SUPPL2007-11-19
25373SUPPL2007-09-25
25372SUPPL2007-09-25
12881SUPPL2007-09-19
12879SUPPL2007-09-19
2934SUPPL2007-07-05
12882SUPPL2007-06-27
12880SUPPL2007-06-04
2932SUPPL2007-06-04
35011SUPPL2007-05-16
2933SUPPL2007-05-16
41499ORIG2007-04-24
35010SUPPL2006-06-28
25371SUPPL2006-06-28
35009SUPPL2006-01-27
35008SUPPL2005-08-08
25370SUPPL2005-08-08
41501SUPPL2005-06-27
20783SUPPL2005-06-27
20782SUPPL2005-06-27
35006SUPPL2004-12-03
2930SUPPL2004-12-02
35007SUPPL2004-11-08
2931SUPPL2004-11-08
35005SUPPL2004-09-15
25369SUPPL2004-09-15
12878SUPPL2004-09-15
2929SUPPL2004-09-15
41500SUPPL2004-09-09
20781SUPPL2004-09-09
35004SUPPL2004-07-21
44455SUPPL2004-06-08
34998SUPPL2004-06-08
35003SUPPL2004-04-05
25368SUPPL2004-03-10
2928SUPPL2003-12-04
35002SUPPL2003-06-08
2927SUPPL2003-06-08
25367SUPPL2002-10-30
35001SUPPL2001-12-18
35000SUPPL2001-12-18
25366SUPPL2001-12-18
25365SUPPL2001-12-18
12877SUPPL2001-12-18
2926SUPPL2001-12-18
34999SUPPL2000-09-08
25364SUPPL2000-09-08