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CRESEMBA

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 useCRESEMBA (isavuconazonium sulfate) for injection, for intravenous useInitial U.S. Approval: 2015

Approved
Approval ID

8f7f73b8-586a-4df0-935f-fecd4696c16c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 8, 2023

Manufacturers
FDA

Astellas Pharma US, Inc.

DUNS: 605764828

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

isavuconazonium sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0469-2860
Application NumberNDA207500
Product Classification
M
Marketing Category
C73594
G
Generic Name
isavuconazonium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification

INGREDIENTS (1)

ISAVUCONAZONIUM SULFATEActive
Quantity: 40 mg in 1 1
Code: 31Q44514JV
Classification: ACTIM

isavuconazonium sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0469-0420
Application NumberNDA207501
Product Classification
M
Marketing Category
C73594
G
Generic Name
isavuconazonium sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 30, 2023
FDA Product Classification

INGREDIENTS (1)

ISAVUCONAZONIUM SULFATEActive
Quantity: 40.0 mg in 1 mL
Code: 31Q44514JV
Classification: ACTIM

isavuconazonium sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0469-0520
Application NumberNDA207500
Product Classification
M
Marketing Category
C73594
G
Generic Name
isavuconazonium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification

INGREDIENTS (1)

ISAVUCONAZONIUM SULFATEActive
Quantity: 100 mg in 1 1
Code: 31Q44514JV
Classification: ACTIM

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CRESEMBA - FDA Drug Approval Details