← FDA DRUG APPROVALS

FDA NDA · NDA022129

ULESFIA

Sponsor: SHIONOGI

APPLICATION
NDA022129
TYPE
NDA
ORIGINAL APPROVAL
2009-04-09
LATEST ACTION
2020-04-26
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

ULESFIA · ReferenceDiscontinued
BENZYL ALCOHOL 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

2020-04-26Labeling · Supplement 8 · standard — Letter ↗AP
2016-03-24Manufacturing (CMC) · Supplement 6AP
2012-07-12Labeling · Supplement 5 · unknown — Label ↗AP
2010-06-22Labeling · Supplement 2 · unknown — Letter ↗AP
2010-02-03Manufacturing (CMC) · Supplement 1AP
2009-04-09Type 1 - New Molecular Entity · Original · standard — 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 →