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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203521

TRANEXAMIC ACID (TRANEXAMIC ACID)
100MG/ML
Marketing Status: Prescription
Active Ingredient: TRANEXAMIC ACID
Proprietary Name: TRANEXAMIC ACID
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203521
Product Number: 001
Approval Date: Aug 12, 2014
Applicant Holder Full Name: AVET LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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