OLPRUVA
NDA 214860 · New Drug Application (NDA) Prescription
SODIUM PHENYLBUTYRATE
- Sponsor (Drugs@FDA)
- ACER Company: Acer Therapeutics Inc.
- First approved
- Latest action
Drugs on HealthTrade
No drug on HealthTrade cites this application. Novel approvals since 2015 by healthcare companies HealthTrade covers are listed from Drugs@FDA automatically, labelled “Not yet reviewed”; editors link the others.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | OLPRUVA SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL 2GM/PACKET | Prescription | – | Reference listed drug | RXApproved |
| 002 | OLPRUVA SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL 3GM/PACKET | Prescription | – | Reference listed drug | RXApproved |
| 003 | OLPRUVA SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL 4GM/PACKET | Prescription | – | Reference listed drug | RXApproved |
| 004 | OLPRUVA SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL 5GM/PACKET | Prescription | – | Reference listed drug, Reference standard | RXApproved |
| 005 | OLPRUVA SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL 6GM/PACKET | Prescription | – | Reference listed drug | RXApproved |
| 006 | OLPRUVA SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL 6.67GM/PACKET | Prescription | – | Reference listed drug | RXApproved |
| 007 | OLPRUVA SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL 0.5GM/PACKET | Prescription | – | Reference listed drug | RXApproved |
| 008 | OLPRUVA SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL 1GM/PACKET | Prescription | – | Reference listed drug | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 7 | Approved | standard | Efficacy | Letter for Supplement 7 (opens in a new tab)Label for Supplement 7 (opens in a new tab) | |
| Original 1 | Approved | standard | Type 5 - New Formulation or New Manufacturer | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
24 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 11154521Product 001 | Drug product | – | ||
| 11202767Product 001 | Method of use | U-3502 | ||
| 11433041Product 001 | Drug product | – | ||
| 11154521Product 002 | Drug product | – | ||
| 11202767Product 002 | Method of use | U-3502 | ||
| 11433041Product 002 | Drug product | – | ||
| 11154521Product 003 | Drug product | – | ||
| 11202767Product 003 | Method of use | U-3502 | ||
| 11433041Product 003 | Drug product | – | ||
| 11154521Product 004 | Drug product | – | ||
| 11202767Product 004 | Method of use | U-3502 | ||
| 11433041Product 004 | Drug product | – | ||
| 11154521Product 005 | Drug product | – | ||
| 11202767Product 005 | Method of use | U-3502 | ||
| 11433041Product 005 | Drug product | – | ||
| 11154521Product 006 | Drug product | – | ||
| 11202767Product 006 | Method of use | U-3502 | ||
| 11433041Product 006 | Drug product | – | ||
| 11154521Product 007 | Drug product | – | ||
| 11202767Product 007 | Method of use | U-3502 | ||
| 11433041Product 007 | Drug product | – | ||
| 11154521Product 008 | Drug product | – | ||
| 11202767Product 008 | Method of use | U-3502 | ||
| 11433041Product 008 | Drug product | – |
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
6 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 72542-200 in openFDA (opens in a new tab) | OLPRUVA sodium phenylbutyrate | Acer Therapeutics Inc. | KIT ORAL | NDA | From |
| 72542-300 in openFDA (opens in a new tab) | OLPRUVA sodium phenylbutyrate | Acer Therapeutics Inc. | KIT ORAL | NDA | From |
| 72542-400 in openFDA (opens in a new tab) | OLPRUVA sodium phenylbutyrate | Acer Therapeutics Inc. | KIT ORAL | NDA | From |
| 72542-500 in openFDA (opens in a new tab) | OLPRUVA sodium phenylbutyrate | Acer Therapeutics Inc. | KIT ORAL | NDA | From |
| 72542-600 in openFDA (opens in a new tab) | OLPRUVA sodium phenylbutyrate | Acer Therapeutics Inc. | KIT ORAL | NDA | From |
| 72542-667 in openFDA (opens in a new tab) | OLPRUVA sodium phenylbutyrate | Acer Therapeutics Inc. | KIT ORAL | NDA | From |
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-11-03.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-11-03.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-11-03.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.