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FDA NDA · NDA021142

OLUX

Sponsor: PHARMOBEDIENT

APPLICATION
NDA021142
TYPE
NDA
ORIGINAL APPROVAL
2000-05-26
LATEST ACTION
2018-04-25
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Discontinued

Products

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CLOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · AEROSOL, FOAM · TOPICAL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

2018-04-25Labeling · Supplement 22 · standard — Label ↗AP
2014-04-23Labeling · Supplement 19 · standard — Letter ↗AP
2013-06-07Manufacturing (CMC) · Supplement 18 · standardAP
2006-07-11Labeling · Supplement 12 · standard — Letter ↗AP
2003-12-29Manufacturing (CMC) · Supplement 10 · standard — Label ↗AP
2003-10-31Labeling · Supplement 9 · standard — Label ↗AP
2003-07-21Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2002-12-20Efficacy · Supplement 4 · standard — Letter ↗AP
2002-09-17Manufacturing (CMC) · Supplement 6 · standardAP
2002-08-21Manufacturing (CMC) · Supplement 5 · standardAP
2002-03-13Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2001-11-29Manufacturing (CMC) · Supplement 2 · standardAP
2000-09-14Manufacturing (CMC) · Supplement 1 · standardAP
2000-05-26Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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