General MedicationsORALStandard
VYBRIQUE
SILDENAFIL CITRATE
Standard Dose
EQ 25MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview VYBRIQUE is listed in Drugs@FDA under application 210858 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SILDENAFIL CITRATE Form and strength FILM;ORAL - EQ 25MG BASE Sponsor IBSA Submission history Latest submission status date: 2025-12-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview VYBRIQUE is listed in Drugs@FDA under application 210858 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SILDENAFIL CITRATE Form and strength FILM;ORAL - EQ 25MG BASE Sponsor IBSA Submission history Latest submission status date: 2025-12-16 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.