FDA.reportPublic FDA data

Application 020657

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPORANOXITRACONAZOLESOLUTION;ORAL10MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10147-0150itraconazoleitraconazolePatriot Pharmaceuticals, LLCNDACurrent
10147-0150itraconazoleitraconazolePatriot Pharmaceuticals, NDACurrent
10147-0150itraconazoleitraconazolePatriot Pharmaceuticals, LLCNDACurrent
10147-0150itraconazoleitraconazolePatriot Pharmaceuticals, LLCNDACurrent
10147-0150itraconazoleitraconazolePatriot Pharmaceuticals, LLCNDACurrent
50458-295SPORANOXitraconazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-295SPORANOXitraconazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-295SPORANOXitraconazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-295SPORANOXitraconazoleJanssen Pharmaceuticals, Inc.NDACurrent
50458-295SPORANOXitraconazoleJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80678SUPPL 2024-12-23
80672SUPPL 2024-12-20
80031SUPPL 2024-10-29
80022SUPPL 2024-10-28
77893SUPPL 2024-03-21
77872SUPPL 2024-03-19
77410SUPPL 2024-02-07
77404SUPPL 2024-02-06
75906SUPPL 2023-10-24
75882SUPPL 2023-10-20
72808SUPPL2022-12-07
72798SUPPL2022-12-06
57948SUPPL2019-03-11
57944SUPPL2019-03-11
50032SUPPL2017-10-12
49992SUPPL2017-10-10
47695SUPPL2017-03-24
47660SUPPL2017-03-23
25451SUPPL2015-04-17
12933SUPPL2015-04-17
3010SUPPL2014-06-11
35085SUPPL2014-06-10
25450SUPPL2012-03-27
12932SUPPL2012-03-27
12931SUPPL2012-03-27
3009SUPPL2012-03-27
25449SUPPL2011-04-19
12930SUPPL2011-04-18
12929SUPPL2011-01-11
3008SUPPL2011-01-07
3007SUPPL2010-08-03
12928SUPPL2010-07-31
35084SUPPL2009-03-17
35083SUPPL2009-03-17
12927SUPPL2009-03-17
12926SUPPL2009-03-17
3006SUPPL2009-03-10
3005SUPPL2009-03-10
3004SUPPL2009-03-10
3003SUPPL2009-03-10
35082SUPPL2003-09-30
3002SUPPL2003-09-30
35080SUPPL2002-09-11
3000SUPPL2002-09-11
35081SUPPL2002-07-17
3001SUPPL2002-07-17
41525SUPPL2001-10-26
41524SUPPL2001-10-26
35079SUPPL2001-04-17
25448SUPPL2001-04-17
12925SUPPL2001-04-17
2999SUPPL2001-04-17