← FDA DRUG APPROVALS

FDA NDA · NDA216660

RELYVRIO

Sponsor: AMYLYX

APPLICATION
NDA216660
TYPE
NDA
ORIGINAL APPROVAL
2022-09-29
LATEST ACTION
2022-09-29
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

RELYVRIO · ReferenceDiscontinued
SODIUM PHENYLBUTYRATE 3GM/PACKET, TAURURSODIOL 1GM/PACKET · FOR SUSPENSION · ORAL

Approval history

2022-09-29Type 1 - New Molecular Entity · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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