FDA.reportPublic FDA data

Application 207500

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CRESEMBAISAVUCONAZONIUM SULFATECAPSULE;ORAL186MGYesYes
002CRESEMBAISAVUCONAZONIUM SULFATECAPSULE;ORAL74.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-0520CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-2860CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent
0469-2860CRESEMBAisavuconazonium sulfateAstellas Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81730SUPPL 2025-03-25
81727SUPPL 2025-03-25
76760SUPPL 2023-12-11
76754SUPPL 2023-12-11
73956SUPPL 2023-04-06
70204SUPPL2022-02-22
70191SUPPL2022-02-18
69545SUPPL2021-12-14
69531SUPPL2021-12-13
67549SUPPL2021-05-19
67545SUPPL2021-05-19
67178SUPPL2021-04-26
67165SUPPL2021-04-23
61225SUPPL2019-12-11
61202SUPPL2019-12-10
19962SUPPL2015-04-28
32854SUPPL2015-04-06
44958ORIG2015-04-03
43533ORIG2015-04-03
40586ORIG2015-03-06
32853ORIG2015-03-06