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General MedicationsORALStandard

PHEBURANE

SODIUM PHENYLBUTYRATE

Standard Dose
84GM/BOT
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PHEBURANE is listed in Drugs@FDA under application 216513 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM PHENYLBUTYRATE Form and strength PELLETS;ORAL - 84GM/BOT Sponsor MEDUNIK Submission history Latest submission status date: 2022-06-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview PHEBURANE is listed in Drugs@FDA under application 216513 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM PHENYLBUTYRATE Form and strength PELLETS;ORAL - 84GM/BOT Sponsor MEDUNIK Submission history Latest submission status date: 2022-06-17 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.