← FDA DRUG APPROVALS

FDA NDA · NDA216675

MIEBO

perfluorohexyloctane

Sponsor: BAUSCH AND LOMB INC

APPLICATION
NDA216675
TYPE
NDA
ORIGINAL APPROVAL
2023-05-18
LATEST ACTION
2025-10-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

MIEBO · ReferencePrescription
PERFLUOROHEXYLOCTANE 1.338GM/ML · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-10-21Labeling · Supplement 9 · standard — Label ↗AP
2023-05-18Type 1 - New Molecular Entity · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →