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General MedicationsTOPICALStandard

OPZELURA

RUXOLITINIB PHOSPHATE

Standard Dose
EQ 1.5% BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OPZELURA is listed in Drugs@FDA under application 215309 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient RUXOLITINIB PHOSPHATE Form and strength CREAM;TOPICAL - EQ 1.5% BASE Sponsor INCYTE CORP Submission history Latest submission status date: 2025-09-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview OPZELURA is listed in Drugs@FDA under application 215309 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient RUXOLITINIB PHOSPHATE Form and strength CREAM;TOPICAL - EQ 1.5% BASE Sponsor INCYTE CORP Submission history Latest submission status date: 2025-09-18 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.