Orange Book product
SODIUM PHENYLBUTYRATE 500MG
Orange Book ANDA 220418 · NAVINTA LLC · Prescription
Key facts
| Proprietary name | SODIUM PHENYLBUTYRATE |
|---|---|
| Active ingredients | SODIUM PHENYLBUTYRATE |
| Strength | 500MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA220418 |
| Applicant holder | NAVINTA LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 17, 2026 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.