← FDA DRUG APPROVALS

FDA NDA · NDA021978

VERDESO

Sponsor: GENUS

APPLICATION
NDA021978
TYPE
NDA
ORIGINAL APPROVAL
2006-09-19
LATEST ACTION
2020-03-30
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Discontinued

Products

VERDESO · ReferenceDiscontinued
DESONIDE 0.05% · AEROSOL, FOAM · TOPICAL

Approval history

2020-03-30Labeling · Supplement 16 · standard — Letter ↗AP
2019-04-15Labeling · Supplement 15 · standard — Letter ↗AP
2016-11-09Manufacturing (CMC) · Supplement 12 · standardAP
2015-08-20Manufacturing (CMC) · Supplement 11 · standardAP
2013-04-02Labeling · Supplement 10 · standard — Label ↗AP
2011-08-22Labeling · Supplement 9 · unknown — Letter ↗AP
2010-04-22Labeling · Supplement 7 · standard — Label ↗AP
2007-05-01Manufacturing (CMC) · Supplement 1AP
2006-09-19Type 3 - New Dosage Form · Original · standard — Summary Review ↗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 →