Application 214860
- Type
- NDA
- Sponsor
- ACER THERAPEUTICS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | 2G | Yes | No |
| 002 | OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | 3G | Yes | No |
| 003 | OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | 4G | Yes | No |
| 004 | OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | 5G | Yes | No |
| 005 | OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | 6G | Yes | No |
| 006 | OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | 6.67G | Yes | No |
| 007 | OLPRUVA | SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL | 0.5GM/PACKET | Yes | No |
| 008 | OLPRUVA | SODIUM PHENYLBUTYRATE | FOR SUSPENSION;ORAL | 1GM/PACKET | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214860-001 | OLPRUVA | SODIUM PHENYLBUTYRATE | 2GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | |
| N214860-002 | OLPRUVA | SODIUM PHENYLBUTYRATE | 3GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | |
| N214860-003 | OLPRUVA | SODIUM PHENYLBUTYRATE | 4GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | |
| N214860-004 | OLPRUVA | SODIUM PHENYLBUTYRATE | 5GM/PACKET | FOR SUSPENSION / ORAL | RLD, RS | 2022-12-22 | |
| N214860-005 | OLPRUVA | SODIUM PHENYLBUTYRATE | 6GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | |
| N214860-006 | OLPRUVA | SODIUM PHENYLBUTYRATE | 6.67GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | |
| N214860-007 | OLPRUVA | SODIUM PHENYLBUTYRATE | 0.5GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2025-10-10 | |
| N214860-008 | OLPRUVA | SODIUM PHENYLBUTYRATE | 1GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2025-10-10 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214860-001 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-001 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | |
| N214860-001 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-002 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-002 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | |
| N214860-002 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-003 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-003 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | |
| N214860-003 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-004 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-004 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | |
| N214860-004 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-005 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-005 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | |
| N214860-005 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-006 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-006 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | |
| N214860-006 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | |
| N214860-007 | 11154521 | 2036-10-17 | Drug product | 2025-11-07 | |
| N214860-007 | 11202767 | 2036-10-17 | U-3502 | 2025-11-07 | |
| N214860-007 | 11433041 | 2036-10-17 | Drug product | 2025-11-07 | |
| N214860-008 | 11154521 | 2036-10-17 | Drug product | 2025-11-07 | |
| N214860-008 | 11202767 | 2036-10-17 | U-3502 | 2025-11-07 | |
| N214860-008 | 11433041 | 2036-10-17 | Drug product | 2025-11-07 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N214860-001 | OLPRUVA | 2GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-002 | OLPRUVA | 3GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-003 | OLPRUVA | 4GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-004 | OLPRUVA | 5GM/PACKET | FOR SUSPENSION / ORAL | RLD, RS | 2022-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-005 | OLPRUVA | 6GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-006 | OLPRUVA | 6.67GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-007 | OLPRUVA | 0.5GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2025-10-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-008 | OLPRUVA | 1GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2025-10-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-001 | OLPRUVA | 2GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-002 | OLPRUVA | 3GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-003 | OLPRUVA | 4GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-004 | OLPRUVA | 5GM/PACKET | FOR SUSPENSION / ORAL | RLD, RS | 2022-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-005 | OLPRUVA | 6GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-006 | OLPRUVA | 6.67GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-007 | OLPRUVA | 0.5GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2025-10-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-008 | OLPRUVA | 1GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2025-10-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214860-001 | OLPRUVA | 2GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214860-002 | OLPRUVA | 3GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214860-003 | OLPRUVA | 4GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214860-004 | OLPRUVA | 5GM/PACKET | FOR SUSPENSION / ORAL | RLD, RS | 2022-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214860-005 | OLPRUVA | 6GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214860-006 | OLPRUVA | 6.67GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214860-001 | OLPRUVA | 2GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214860-002 | OLPRUVA | 3GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214860-003 | OLPRUVA | 4GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214860-004 | OLPRUVA | 5GM/PACKET | FOR SUSPENSION / ORAL | RLD, RS | 2022-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214860-005 | OLPRUVA | 6GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214860-006 | OLPRUVA | 6.67GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214860-001 | OLPRUVA | 2GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214860-002 | OLPRUVA | 3GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214860-003 | OLPRUVA | 4GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214860-004 | OLPRUVA | 5GM/PACKET | FOR SUSPENSION / ORAL | RLD, RS | 2022-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214860-005 | OLPRUVA | 6GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214860-006 | OLPRUVA | 6.67GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214860-001 | OLPRUVA | 2GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214860-002 | OLPRUVA | 3GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214860-003 | OLPRUVA | 4GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214860-004 | OLPRUVA | 5GM/PACKET | FOR SUSPENSION / ORAL | RLD, RS | 2022-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214860-005 | OLPRUVA | 6GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214860-006 | OLPRUVA | 6.67GM/PACKET | FOR SUSPENSION / ORAL | RLD | 2022-12-22 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N214860-001 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-001 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-001 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-002 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-002 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-002 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-003 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-003 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-003 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-004 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-004 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-004 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-005 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-005 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-005 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-006 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-006 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-006 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-007 | 11154521 | 2036-10-17 | Drug product | 2025-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-007 | 11202767 | 2036-10-17 | U-3502 | 2025-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-007 | 11433041 | 2036-10-17 | Drug product | 2025-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-008 | 11154521 | 2036-10-17 | Drug product | 2025-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-008 | 11202767 | 2036-10-17 | U-3502 | 2025-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214860-008 | 11433041 | 2036-10-17 | Drug product | 2025-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-001 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-001 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-001 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-002 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-002 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-002 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-003 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-003 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-003 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-004 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-004 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-004 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-005 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-005 | 11202767 | 2036-10-17 | U-3502 | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-005 | 11433041 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214860-006 | 11154521 | 2036-10-17 | Drug product | 2023-01-12 | 31067a03dcf5… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PHEBURANE | SODIUM PHENYLBUTYRATE | Medunik USA | d15f2cbf-4d22-40b5-8ef9-16b9d323a7f9 | 2026-07-17 | Warnings, Adverse reactions | SODIUM PHENYLBUTYRATE |
| Sodium phenylbutyrate | SODIUM PHENYLBUTYRATE | Navinta LLC | c564778d-b285-4d1d-a641-9d4ee76079cf | 2026-07-09 | Warnings, Adverse reactions | SODIUM PHENYLBUTYRATE |
| Sodium phenylbutyrate | SODIUM PHENYLBUTYRATE | Zydus Pharmaceuticals USA Inc. | d08fd548-7eb8-4f6f-b664-b0fff6f30065 | 2026-04-28 | Warnings, Adverse reactions | SODIUM PHENYLBUTYRATE |
| Sodium Phenylbutyrate | SODIUM PHENYLBUTYRATE | Par Health USA, LLC | 639f5c7e-9f6d-47fb-a417-2be076176a78 | 2026-04-14 | Warnings, Adverse reactions | SODIUM PHENYLBUTYRATE |
| sodium phenylbutyrate | SODIUM PHENYLBUTYRATE | GLENMARK PHARMACEUTICALS INC., USA | 0c76d25b-abac-41a3-a547-4fa4796bf7a4 | 2026-01-28 | Warnings, Adverse reactions | SODIUM PHENYLBUTYRATE |
| BUPHENYL | SODIUM PHENYLBUTYRATE | Horizon Therapeutics USA, Inc. | 463a36fa-3eb2-4326-8bd0-c8c7a11bca3a | 2024-10-30 | Warnings, Adverse reactions | SODIUM PHENYLBUTYRATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72542-200 | OLPRUVA | sodium phenylbutyrate | Acer Therapeutics Inc. | NDA | Current |
| 72542-300 | OLPRUVA | sodium phenylbutyrate | Acer Therapeutics Inc. | NDA | Current |
| 72542-400 | OLPRUVA | sodium phenylbutyrate | Acer Therapeutics Inc. | NDA | Current |
| 72542-500 | OLPRUVA | sodium phenylbutyrate | Acer Therapeutics Inc. | NDA | Current |
| 72542-600 | OLPRUVA | sodium phenylbutyrate | Acer Therapeutics Inc. | NDA | Current |
| 72542-667 | OLPRUVA | sodium phenylbutyrate | Acer Therapeutics Inc. | NDA | Current |