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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216660

RELYVRIO (SODIUM PHENYLBUTYRATE; TAURURSODIOL)
3GM/PACKET; 1GM/PACKET
Marketing Status: Prescription
Active Ingredient: SODIUM PHENYLBUTYRATE; TAURURSODIOL
Proprietary Name: RELYVRIO
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 3GM/PACKET; 1GM/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216660
Product Number: 001
Approval Date: Sep 29, 2022
Applicant Holder Full Name: AMYLYX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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