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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207604

0.4MG/5ML (0.08MG/ML)
Marketing Status: Prescription
Active Ingredient: REGADENOSON
Proprietary Name: REGADENOSON
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.4MG/5ML (0.08MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207604
Product Number: 001
Approval Date: Apr 11, 2022
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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