Drug application
RELYVRIO (SODIUM PHENYLBUTYRATE, TAURURSODIOL)
Drugs@FDA NDA 216660 · AMYLYX
Key facts
| Drug name | RELYVRIO |
|---|---|
| Active ingredients | SODIUM PHENYLBUTYRATE, TAURURSODIOL |
| Application type | NDA |
| Application number | 216660 |
| Company | AMYLYX |
| Dosage forms | FOR SUSPENSION, ORAL |
| Strength | 3GM/PACKET; 1GM/PACKET |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 1 - New Molecular Entity |
| Latest submission status date | Sep 29, 2022 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: