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General MedicationsORALStandard

SEPHIENCE

SEPIAPTERIN

Standard Dose
250MG/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SEPHIENCE is listed in Drugs@FDA under application 219666 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SEPIAPTERIN Form and strength POWDER;ORAL - 250MG/PACKET Sponsor PTC THERAP Submission history Latest submission status date: 2025-07-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview SEPHIENCE is listed in Drugs@FDA under application 219666 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SEPIAPTERIN Form and strength POWDER;ORAL - 250MG/PACKET Sponsor PTC THERAP Submission history Latest submission status date: 2025-07-28 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.