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.