← FDA DRUG APPROVALS

FDA NDA · NDA209569

TISSUEBLUE

brilliant blue g

Sponsor: DUTCH OPHTHALMIC

APPLICATION
NDA209569
TYPE
NDA
ORIGINAL APPROVAL
2019-12-20
LATEST ACTION
2025-04-04
ROUTE
INTRAOCULAR, OPHTHALMIC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TISSUEBLUE · ReferencePrescription
BRILLIANT BLUE G 0.025% · SOLUTION · OPHTHALMIC

Approval history

2025-04-04Labeling · Supplement 6 · standardLabelAP
2022-03-30Labeling · Supplement 4 · standardLetterAP
2019-12-20Type 1 - New Molecular Entity · Original · priorityLabelAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →