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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022161

0.4MG/5ML (0.08MG/ML)
Marketing Status: Prescription
Active Ingredient: REGADENOSON
Proprietary Name: LEXISCAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.4MG/5ML (0.08MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022161
Product Number: 001
Approval Date: Apr 10, 2008
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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