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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205133

TRANEXAMIC ACID (TRANEXAMIC ACID)
650MG
Marketing Status: Prescription
Active Ingredient: TRANEXAMIC ACID
Proprietary Name: TRANEXAMIC ACID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 650MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205133
Product Number: 001
Approval Date: Sep 21, 2015
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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