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 two suppliers. There are two 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 nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.

Summary for 022161

Tradename:	LEXISCAN
Applicant:	Astellas
Ingredient:	regadenoson
Patents:	2

Pharmacology for NDA: 022161

Mechanism of Action	Adenosine 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)
LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1448	51662-1448-1	1 SYRINGE, PLASTIC in 1 CARTON (51662-1448-1) / 5 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.4MG/5ML (0.08MG/ML)
Approval Date:	Apr 10, 2008	TE:	AP	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 2, 2027	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Feb 2, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022161

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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