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General MedicationsORALStandard

SOHONOS

PALOVAROTENE

Standard Dose
2.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SOHONOS is listed in Drugs@FDA under application 215559 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PALOVAROTENE Form and strength CAPSULE;ORAL - 2.5MG Sponsor IPSEN Submission history Latest submission status date: 2025-03-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview SOHONOS is listed in Drugs@FDA under application 215559 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PALOVAROTENE Form and strength CAPSULE;ORAL - 2.5MG Sponsor IPSEN Submission history Latest submission status date: 2025-03-13 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.