← FDA DRUG APPROVALS

FDA NDA · NDA210858

VYBRIQUE

sildenafil citrate

Sponsor: IBSA

APPLICATION
NDA210858
TYPE
NDA
ORIGINAL APPROVAL
2025-12-16
LATEST ACTION
2025-12-16
ROUTE
ORAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription

Products

VYBRIQUE · ReferencePrescription
SILDENAFIL CITRATE EQ 100MG BASE · FILM · ORAL
VYBRIQUE · ReferencePrescription
SILDENAFIL CITRATE EQ 50MG BASE · FILM · ORAL
VYBRIQUE · ReferencePrescription
SILDENAFIL CITRATE EQ 75MG BASE · FILM · ORAL
VYBRIQUE · ReferencePrescription
SILDENAFIL CITRATE EQ 25MG BASE · FILM · ORAL

Approval history

2025-12-16Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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