FDA.reportPublic FDA data

Application 207501

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CRESEMBAISAVUCONAZONIUM SULFATEPOWDER;INTRAVENOUS372MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0420CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81731SUPPL 2025-03-25
81728SUPPL 2025-03-25
76762SUPPL 2023-12-11
76761SUPPL 2023-12-11
70205SUPPL2022-02-22
70192SUPPL2022-02-18
69546SUPPL2021-12-14
69532SUPPL2021-12-13
67550SUPPL2021-05-19
67546SUPPL2021-05-19
67179SUPPL2021-04-26
67166SUPPL2021-04-23
61226SUPPL2019-12-11
61203SUPPL2019-12-10
40588SUPPL2015-04-28
10618SUPPL2015-04-06
44959ORIG2015-04-03
23035ORIG2015-04-03
40587ORIG2015-03-06
10617ORIG2015-03-06