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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211215

250MG/50ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: BIVALIRUDIN
Proprietary Name: ANGIOMAX RTU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 250MG/50ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211215
Product Number: 001
Approval Date: Jul 25, 2019
Applicant Holder Full Name: MAIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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