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Details for New Drug Application (NDA): 022161

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NDA 022161 describes LEXISCAN, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LEXISCAN profile page.

The generic ingredient in LEXISCAN is regadenoson. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regadenoson profile page.

Summary for NDA: 022161

Tradename:
LEXISCAN
Applicant:
Astellas
Ingredient:
regadenoson
Patents:17

Pharmacology for NDA: 022161

Mechanism of ActionAdenosine Receptor Agonists

Suppliers and Packaging for NDA: 022161

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS 022161 NDA Astellas Pharma US, Inc. 0469-6501 0469-6501-89 5 mL in 1 SYRINGE, PLASTIC (0469-6501-89)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.4MG/5ML (0.08MG/ML)
Approval Date:Apr 10, 2008TE:RLD:Yes
Patent:8,106,183Patent Expiration:Feb 2, 2027Product Flag?Substance Flag?YDelist Request?
Patent:8,133,879Patent Expiration:Jun 22, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:9,045,519Patent Expiration:Jun 22, 2019Product Flag?YSubstance Flag?Delist Request?


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