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Generated: May 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207500

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NDA 207500 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: 207500


Suppliers and Packaging for NDA: 207500

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
isavuconazonium sulfate
CAPSULE;ORAL 207500 NDA Astellas Pharma US, Inc. 0469-0520 0469-0520-14 4 CARTON in 1 CARTON (0469-0520-14) > 14 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength186MG
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

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