isavuconazonium Injection

Brand(s)
Cresemba
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fujisawa Healthcare, Inc. (2015-06-30)
Oldest Current Product
2015-03-06
License(s)
NDA
RxNORM
INJECTION\ISAVUCONAZONIUM
FDAOB
IV (INFUSION)\POWDER\ISAVUCONAZONIUM SULFATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ISAVUCONAZONIUM SULFATE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ISAVUCONAZOLE

product(s) by strength(s)

isavuconazonium sulfate 372 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690420CresembaNDAFujisawa Healthcare, Inc.2015-03-06ISAVUCONAZONIUM SULFATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA2075018f7f73b8-586a-4df0-935f-fecd4696c16c

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207501CRESEMBAASTELLAS PHARMA US INC2015-03-06p6812238
p7459561
NEW CHEMICAL ENTITY [2020-03-06]
ORPHAN DRUG EXCLUSIVITY [2022-03-06]
Generating Antibiotic Incentives Now [2027-03-06]
Generating Antibiotic Incentives Now [2025-03-06]
NDA207501_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA207501_001RXISAVUCONAZONIUM SULFATE (372MG)POWDERTrue2015-03-06CRESEMBA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6812238 (view patent)2020-10-31NDA207501, NDA207500isavuconazonium Oral Capsule
2p7459561 (view patent)2020-10-31NDA207501, NDA207500isavuconazonium Oral Capsule

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.2015-06-305004690420, 004690520isavuconazonium Oral Capsule

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