APPLICATION
NDA019117
TYPE
NDA
ORIGINAL APPROVAL
1984-06-26
LATEST ACTION
2015-11-10
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
FLUOCINONIDE · ReferenceDiscontinued
FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
Approval history
2015-11-10Manufacturing (CMC) · Supplement 39AP
2015-06-05Manufacturing (CMC) · Supplement 35AP
2014-10-27Manufacturing (CMC) · Supplement 38AP
2003-07-01Labeling · Supplement 18AP
2001-05-09Manufacturing (CMC) · Supplement 12AP
1996-09-17Manufacturing (CMC) · Supplement 11AP
1996-05-14Manufacturing (CMC) · Supplement 10AP
1993-09-09Manufacturing (CMC) · Supplement 9AP
1991-11-04Manufacturing (CMC) · Supplement 7AP
1991-04-30Manufacturing (CMC) · Supplement 6AP
1991-04-30Manufacturing (CMC) · Supplement 5AP
1991-02-19Labeling · Supplement 8AP
1989-07-12Labeling · Supplement 4AP
1985-03-08Manufacturing (CMC) · Supplement 2AP
1984-06-26OriginalAP
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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