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FDA NDA · NDA021844

DESONATE

Sponsor: LEO PHARMA AS

APPLICATION
NDA021844
TYPE
NDA
ORIGINAL APPROVAL
2006-10-20
LATEST ACTION
2016-03-14
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

DESONATE · ReferenceDiscontinued
DESONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · TOPICAL

Approval history

2016-03-14Manufacturing (CMC) · Supplement 10 · standardAP
2015-01-12Manufacturing (CMC) · Supplement 9 · standardAP
2014-07-22Labeling · Supplement 8 · standard — Letter ↗AP
2009-12-29Labeling · Supplement 2 · standard — Letter ↗AP
2006-10-20Type 3 - New Dosage Form · Original · standard — 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.

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