← FDA DRUG APPROVALS

FDA NDA · NDA020934

LUXIQ

Sponsor: PHARMOBEDIENT

APPLICATION
NDA020934
TYPE
NDA
ORIGINAL APPROVAL
1999-02-28
LATEST ACTION
2006-07-11
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Discontinued

Products

LUXIQ · ReferenceDiscontinued
BETAMETHASONE VALERATE 0.12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · AEROSOL, FOAM · TOPICAL

Approval history

2006-07-11Labeling · Supplement 16 · standard — Label ↗AP
2006-06-16Manufacturing (CMC) · Supplement 15AP
2003-12-29Manufacturing (CMC) · Supplement 12 · standard — Letter ↗AP
2003-10-31Labeling · Supplement 11 · standard — Letter ↗AP
2002-11-03Manufacturing (CMC) · Supplement 8 · standardAP
2002-10-09Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2002-10-08Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2002-05-06Manufacturing (CMC) · Supplement 5 · standardAP
2002-02-28Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2000-11-12Labeling · Supplement 1 · standardAP
1999-02-28Type 3 - New Dosage Form · Original · standard — Review ↗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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