General MedicationsORALStandard

SODIUM PHENYLBUTYRATE

Standard Dose

3GM/TEASPOONFUL

Max Dose

Refer to approved labeling

Primary Use

Marketing status: Prescription

Summary

Approval overview SODIUM PHENYLBUTYRATE is listed in Drugs@FDA under application 203918 (ANDA).

Marketing status: Prescription Active ingredient SODIUM PHENYLBUTYRATE Form and strength POWDER;ORAL - 3GM/TEASPOONFUL Sponsor PH HEALTH Submission history Latest submission status date: 2016-06-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview SODIUM PHENYLBUTYRATE is listed in Drugs@FDA under application 203918 (ANDA). Marketing status: Prescription Active ingredient SODIUM PHENYLBUTYRATE Form and strength POWDER;ORAL - 3GM/TEASPOONFUL Sponsor PH HEALTH Submission history Latest submission status date: 2016-06-15 00:00:00. Submission type: ORIG.

Monitoring

• Review priority: STANDARD
• Marketing status: Prescription

Interaction Notes

No interaction notes stored yet.