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General MedicationsOPHTHALMICStandard

EPIOXA HD/EPIOXA KIT

RIBOFLAVIN 5'-PHOSPHATE SODIUM

Standard Dose
EQ 0.239% BASE/ML;EQ 0.177% BASE/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview EPIOXA HD/EPIOXA KIT is listed in Drugs@FDA under application 219910 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient RIBOFLAVIN 5'-PHOSPHATE SODIUM Form and strength SOLUTION/DROPS;OPHTHALMIC - EQ 0.239% BASE/ML;EQ 0.177% BASE/ML Sponsor GLAUKOS Submission history Latest submission status date: 2025-10-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview EPIOXA HD/EPIOXA KIT is listed in Drugs@FDA under application 219910 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient RIBOFLAVIN 5'-PHOSPHATE SODIUM Form and strength SOLUTION/DROPS;OPHTHALMIC - EQ 0.239% BASE/ML;EQ 0.177% BASE/ML Sponsor GLAUKOS Submission history Latest submission status date: 2025-10-17 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.