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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022430

LYSTEDA (TRANEXAMIC ACID)
650MG
Marketing Status: Prescription
Active Ingredient: TRANEXAMIC ACID
Proprietary Name: LYSTEDA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 650MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022430
Product Number: 001
Approval Date: Nov 13, 2009
Applicant Holder Full Name: AMRING PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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