MedPath
FDA Approval

CRESEMBA

December 8, 2023

HUMAN PRESCRIPTION DRUG LABEL

Isavuconazonium(40 mg in 1 1)

Products (3)

CRESEMBA

0469-2860

NDA207500

NDA (C73594)

ORAL

May 30, 2023

Code: 31Q44514JVClass: ACTIMQuantity: 40 mg in 1 1

CRESEMBA

0469-0420

NDA207501

NDA (C73594)

INTRAVENOUS

May 30, 2023

Code: 31Q44514JVClass: ACTIMQuantity: 40.0 mg in 1 mL

CRESEMBA

0469-0520

NDA207500

NDA (C73594)

ORAL

May 30, 2023

Code: 31Q44514JVClass: ACTIMQuantity: 100 mg in 1 1
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