Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207500

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CRESEMBA (ISAVUCONAZONIUM SULFATE)
74.5MG
Marketing Status: Prescription

Active Ingredient: ISAVUCONAZONIUM SULFATE
Proprietary Name: CRESEMBA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 74.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207500
Product Number: 002
Approval Date: Nov 22, 2022
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CRESEMBA (ISAVUCONAZONIUM SULFATE)
186MG
Marketing Status: Prescription

Active Ingredient: ISAVUCONAZONIUM SULFATE
Proprietary Name: CRESEMBA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 186MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207500
Product Number: 001
Approval Date: Mar 6, 2015
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information