← FDA DRUG APPROVALS

FDA NDA · NDA021670

VISIONBLUE

trypan blue

Sponsor: DORC

APPLICATION
NDA021670
TYPE
NDA
ORIGINAL APPROVAL
2004-12-16
LATEST ACTION
2023-12-18
ROUTE
INTRAOCULAR, OPHTHALMIC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VISIONBLUE · ReferencePrescription
TRYPAN BLUE 0.06% · SOLUTION · OPHTHALMIC

Approval history

2023-12-18Labeling · Supplement 11 · standard — Letter ↗AP
2015-04-17Manufacturing (CMC) · Supplement 7 · priorityAP
2014-08-25Manufacturing (CMC) · Supplement 6 · priorityAP
2012-11-21Labeling · Supplement 5 · standard — Label ↗AP
2004-12-16Type 1 - New Molecular Entity · Original · priority — Label ↗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 →