General MedicationsORALGeneric
RELYVRIO
SODIUM PHENYLBUTYRATE; TAURURSODIOL
Standard Dose
3GM/PACKET; 1GM/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Discontinued
Summary
Approval overview RELYVRIO is listed in Drugs@FDA under application 216660 (NDA).
Review priority: PRIORITY Marketing status: Discontinued Active ingredient SODIUM PHENYLBUTYRATE; TAURURSODIOL Form and strength FOR SUSPENSION;ORAL - 3GM/PACKET; 1GM/PACKET Sponsor AMYLYX Submission history Latest submission status date: 2022-09-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview RELYVRIO is listed in Drugs@FDA under application 216660 (NDA). Review priority: PRIORITY Marketing status: Discontinued Active ingredient SODIUM PHENYLBUTYRATE; TAURURSODIOL Form and strength FOR SUSPENSION;ORAL - 3GM/PACKET; 1GM/PACKET Sponsor AMYLYX Submission history Latest submission status date: 2022-09-29 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Discontinued
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.