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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212020

TRANEXAMIC ACID (TRANEXAMIC ACID)
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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N212020
Product Number: 001
Approval Date: Apr 15, 2019
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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