FDA NDA · NDA217064

RYZUMVI

Sponsor: FAMYGEN LIFE SCI

What this page does not claim

A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.

APPLICATION
NDA217064
TYPE
NDA
ORIGINAL APPROVAL
2023-09-25
LATEST ACTION
2026-10-16
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RYZUMVI · ReferencePrescription
PHENTOLAMINE MESYLATE EQ 0.75% BASE · SOLUTION · OPHTHALMIC

Approval history

2026-10-16Efficacy · Supplement 5 · standard — Label ↗AP
2026-03-12Manufacturing (CMC) · Supplement 4 — Label ↗AP
2023-11-28Labeling · Supplement 1 · standard — Label ↗AP
2023-09-25Type 3 - New Dosage Form · Original · standard — Label ↗AP