Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205962

Marketing Status: Prescription
Active Ingredient: BIVALIRUDIN
Proprietary Name: BIVALIRUDIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 250MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205962
Product Number: 001
Approval Date: Jul 27, 2018
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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