FDA.reportPublic FDA data

Application 206110

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CASPOFUNGIN ACETATECASPOFUNGIN ACETATEPOWDER;INTRAVENOUS50MG/VIALNoNo
002CASPOFUNGIN ACETATECASPOFUNGIN ACETATEPOWDER;INTRAVENOUS70MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-356Caspofungin AcetateCaspofungin AcetateFresenius Kabi USA, LLCNDACurrent
63323-356Caspofungin AcetateCaspofungin AcetateFresenius Kabi USA, LLCNDACurrent
63323-358Caspofungin AcetateCaspofungin AcetateFresenius Kabi USA, LLCNDACurrent
63323-358Caspofungin AcetateCaspofungin AcetateFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66990SUPPL2021-04-05
66984SUPPL2021-04-02
54829SUPPL2018-07-06
54767SUPPL2018-07-05
50206ORIG2017-10-27
50204ORIG2017-10-27
46668ORIG2017-01-05
46658ORIG2017-01-03