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Details for New Drug Application (NDA): 207501

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NDA 207501 describes CRESEMBA, which is a drug marketed by Astellas and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the CRESEMBA profile page.

The generic ingredient in CRESEMBA is isavuconazonium sulfate. One supplier is listed for this compound. Additional details are available on the isavuconazonium sulfate profile page.

Summary for NDA: 207501

Tradename:
CRESEMBA
Applicant:
Astellas
Ingredient:
isavuconazonium sulfate
Patents:2

Suppliers and Packaging for NDA: 207501

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CRESEMBA
isavuconazonium sulfate
POWDER;IV (INFUSION) 207501 NDA Astellas Pharma US, Inc. 0469-0420 0469-0420-99 10 CARTON in 1 CARTON (0469-0420-99) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength372MG
Approval Date:Mar 6, 2015TE:RLD:Yes
Patent:6,812,238Patent Expiration:Oct 31, 2020Product Flag?Substance Flag?YDelist Request?
Patent:7,459,561Patent Expiration:Oct 31, 2020Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Mar 6, 2025
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW


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