FDA Approval for OLPRUVA issued to ACER THERAPEUTICS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 214860
Company: ACER THERAPEUTICS INC
Company: ACER THERAPEUTICS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLPRUVA | SODIUM PHENYLBUTYRATE | 2G | SUSPENSION;ORAL | Prescription | None | TBD | No |
| OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | Prescription | None | TBD | No | |
| OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | Prescription | None | TBD | No | |
| OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | Prescription | None | TBD | No | |
| OLPRUVA | SODIUM PHENYLBUTYRATE | SUSPENSION;ORAL | Prescription | None | TBD | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/22/2022 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
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