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General MedicationsORALStandard

GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Standard Dose
1.1GM/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GLYCEROL PHENYLBUTYRATE is listed in Drugs@FDA under application 205742 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCEROL PHENYLBUTYRATE Form and strength LIQUID;ORAL - 1.1GM/ML Sponsor PH HEALTH Submission history Latest submission status date: 2021-12-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview GLYCEROL PHENYLBUTYRATE is listed in Drugs@FDA under application 205742 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCEROL PHENYLBUTYRATE Form and strength LIQUID;ORAL - 1.1GM/ML Sponsor PH HEALTH Submission history Latest submission status date: 2021-12-02 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.