FDA.reportPublic FDA data

Application 021632

Type
NDA
Sponsor
VICURON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERAXISANIDULAFUNGINPOWDER;INTRAVENOUS50MG/VIALYesYes
002ERAXISANIDULAFUNGINPOWDER;INTRAVENOUS100MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-0114ERAXISanidulafunginRoerigNDACurrent
0049-0114ERAXISanidulafunginRoerigNDACurrent
0049-0114ERAXISanidulafunginRoerigNDACurrent
0049-0114ERAXISanidulafunginRoerigNDACurrent
0049-0116ERAXISanidulafunginRoerigNDACurrent
0049-0116ERAXISanidulafunginRoerigNDACurrent
0049-0116ERAXISanidulafunginRoerigNDACurrent
0049-0116ERAXISanidulafunginRoerigNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64852SUPPL2020-10-06
64844SUPPL2020-10-06
64670SUPPL2020-09-24
64669SUPPL2020-09-24
64661SUPPL2020-09-23
64660SUPPL2020-09-23
51005SUPPL2018-01-09
50999SUPPL2018-01-09
49504SUPPL2017-08-22
49464SUPPL2017-08-18
28283SUPPL2012-07-24
37371SUPPL2012-07-23
28284SUPPL2010-11-09
5892SUPPL2009-06-16
37370SUPPL2009-06-10
28282SUPPL2007-11-19
37369SUPPL2007-11-13
37368SUPPL2007-02-21
5891SUPPL2007-02-12
28281SUPPL2006-11-22
15903SUPPL2006-11-16
15902SUPPL2006-08-09
5890SUPPL2006-08-09
21763ORIG2006-04-14
28280ORIG2006-03-01
15901ORIG2006-02-28