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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207501

CRESEMBA (ISAVUCONAZONIUM SULFATE)
372MG
Marketing Status: Prescription
Active Ingredient: ISAVUCONAZONIUM SULFATE
Proprietary Name: CRESEMBA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 372MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207501
Product Number: 001
Approval Date: Mar 6, 2015
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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