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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216513
Company: MEDUNIK

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHEBURANE SODIUM PHENYLBUTYRATE 84GM/BOT PELLETS;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
06/17/2022 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216513s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216513Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216513Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/16/2026 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216513s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216513Orig1s007ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/16/2026 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216513s007lbl.pdf
06/17/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216513s000lbl.pdf
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