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FDA NDA · NDA022013

OLUX E

Sponsor: PHARMOBEDIENT

APPLICATION
NDA022013
TYPE
NDA
ORIGINAL APPROVAL
2007-01-12
LATEST ACTION
2018-05-14
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Discontinued

Products

OLUX E · ReferenceDiscontinued
CLOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · AEROSOL, FOAM · TOPICAL

Approval history

2018-05-14Labeling · Supplement 13 · standard — Letter ↗AP
2016-04-21Manufacturing (CMC) · Supplement 11 · standardAP
2013-04-23Labeling · Supplement 9 · standard — Label ↗AP
2010-11-10Labeling · Supplement 5 · unknown — Letter ↗AP
2007-07-17Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2007-01-12Type 5 - New Formulation or New Manufacturer · Original · standard — 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.

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