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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218860

IQIRVO (ELAFIBRANOR)
80MG
Marketing Status: Prescription
Active Ingredient: ELAFIBRANOR
Proprietary Name: IQIRVO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218860
Product Number: 001
Approval Date: Jun 10, 2024
Applicant Holder Full Name: IPSEN BIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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