isavuconazonium Oral Capsule

Brand(s)
Cresemba
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fujisawa Healthcare, Inc. (2015-06-30)
Oldest Current Product
2015-11-04
License(s)
NDA
RxNORM
ORAL CAPSULE\ISAVUCONAZONIUM
FDAOB
ORAL\CAPSULE\ISAVUCONAZONIUM SULFATE
SPL Active
ORAL\CAPSULE\ISAVUCONAZONIUM SULFATE
SPL Moiety
ORAL\CAPSULE\ISAVUCONAZOLE

product(s) by strength(s)

isavuconazonium sulfate 186 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690520CresembaNDAFujisawa Healthcare, Inc.2015-11-04ISAVUCONAZONIUM SULFATEORALCAPSULENDA2075008f7f73b8-586a-4df0-935f-fecd4696c16c

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207500CRESEMBAASTELLAS PHARMA US INC2015-03-06p6812238
p7459561
NEW CHEMICAL ENTITY [2020-03-06]
Generating Antibiotic Incentives Now [2027-03-06]
Generating Antibiotic Incentives Now [2025-03-06]
ORPHAN DRUG EXCLUSIVITY [2022-03-06]
NDA207500_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207500_001RXISAVUCONAZONIUM SULFATE (186MG)ORALCAPSULETrue2015-03-06CRESEMBA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6812238 (view patent)2020-10-31NDA207500, NDA207501isavuconazonium Injection
2p7459561 (view patent)2020-10-31NDA207500, NDA207501isavuconazonium Injection

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
18f7f73b8-586a-4df0-935f-fecd4696c16c (view SPL)These highlights do not include all the information needed to use CRESEMBA safely and effectively. See full prescribing information for CRESEMBA. CRESEMBA (isavuconazonium sulfate) Capsules for oral administrationFor Injection for intravenous administrationInitial U.S. Approval: 2015prescriptionHuman PrescriptionFujisawa Healthcare, Inc.2015-06-305004690520, 004690420isavuconazonium Injection

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII