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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214860
Company: ACER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLPRUVA SODIUM PHENYLBUTYRATE 2GM/PACKET FOR SUSPENSION;ORAL Prescription None Yes No
OLPRUVA SODIUM PHENYLBUTYRATE 3GM/PACKET FOR SUSPENSION;ORAL Prescription None Yes No
OLPRUVA SODIUM PHENYLBUTYRATE 4GM/PACKET FOR SUSPENSION;ORAL Prescription None Yes No
OLPRUVA SODIUM PHENYLBUTYRATE 5GM/PACKET FOR SUSPENSION;ORAL Prescription None Yes No
OLPRUVA SODIUM PHENYLBUTYRATE 6GM/PACKET FOR SUSPENSION;ORAL Prescription None Yes No
OLPRUVA SODIUM PHENYLBUTYRATE 6.67GM/PACKET FOR SUSPENSION;ORAL Prescription None Yes Yes

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 STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214860s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214860Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214860Orig1s000TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/22/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214860s000lbl.pdf
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