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General MedicationsORALStandard

EDURANT PED

RILPIVIRINE HYDROCHLORIDE

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

Approval overview EDURANT PED is listed in Drugs@FDA under application 219016 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient RILPIVIRINE HYDROCHLORIDE Form and strength TABLET, FOR SUSPENSION;ORAL - EQ 2.5MG BASE Sponsor JANSSEN PRODS Submission history Latest submission status date: 2024-03-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview EDURANT PED is listed in Drugs@FDA under application 219016 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient RILPIVIRINE HYDROCHLORIDE Form and strength TABLET, FOR SUSPENSION;ORAL - EQ 2.5MG BASE Sponsor JANSSEN PRODS Submission history Latest submission status date: 2024-03-15 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.
EDURANT PED (RILPIVIRINE HYDROCHLORIDE) | Drug Monograph | MedicHelpline