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LEXISCAN(R) (REGADENOSON)

LEXISCAN(R) (REGADENOSON) INJECTION 0.4mg/5mL (0.08 mg/mL) 5mL SYR

Approved
Approval ID

99640071-4db2-9317-e053-2995a90a610d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 28, 2024

Manufacturers
FDA

HF Acquisition Co LLC, DBA HealthFirst

DUNS: 045657305

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LEXISCAN(R) (REGADENOSON)

PRODUCT DETAILS

NDC Product Code51662-1448
Application NumberNDA022161
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJanuary 28, 2024
Generic NameLEXISCAN(R) (REGADENOSON)

INGREDIENTS (1)

REGADENOSONActive
Quantity: 0.08 mg in 1 mL
Code: 2XLN4Y044H
Classification: ACTIM

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LEXISCAN(R) (REGADENOSON) - FDA Drug Approval Details