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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217155

1GM/100ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: TRANEXAMIC ACID
Proprietary Name: TRANEXAMIC ACID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217155
Product Number: 001
Approval Date: Oct 16, 2023
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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