← FDA DRUG APPROVALS

FDA NDA · NDA021119

VISUDYNE

verteporfin for injection

Sponsor: BAUSCH LOMB IRELAND

APPLICATION
NDA021119
TYPE
NDA
ORIGINAL APPROVAL
2000-04-12
LATEST ACTION
2023-02-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VISUDYNE · ReferencePrescription
VERTEPORFIN 15MG/VIAL · INJECTABLE · INJECTION

Approval history

2023-02-12Labeling · Supplement 34 · standard — Letter ↗AP
2021-07-09Labeling · Supplement 29 · standard — Label ↗AP
2016-05-11Labeling · Supplement 27 · standard — Letter ↗AP
2014-05-06Manufacturing (CMC) · Supplement 26 · priorityAP
2013-10-08Manufacturing (CMC) · Supplement 25 · priorityAP
2012-06-28Labeling · Supplement 22 · standard — Label ↗AP
2008-06-30Efficacy · Supplement 13 · unknown — Letter ↗AP
2007-03-28Labeling · Supplement 21 · standard — Letter ↗AP
2005-03-25Labeling · Supplement 12 · standard — Label ↗AP
2004-02-12Labeling · Supplement 6 · standard — Letter ↗AP
2004-02-12Manufacturing (CMC) · Supplement 10 · priority — Letter ↗AP
2002-11-25Labeling · Supplement 5 · standard — Letter ↗AP
2002-05-29Manufacturing (CMC) · Supplement 4 · priority — Label ↗AP
2002-04-30Labeling · Supplement 3 · standard — Review ↗AP
2002-02-15Manufacturing (CMC) · Supplement 2 · priorityAP
2001-08-22Efficacy · Supplement 1 · priority — Label ↗AP
2000-04-12Type 1 - New Molecular Entity · Original · priority — 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 →