APPLICATION
NDA018116
TYPE
NDA
ORIGINAL APPROVAL
1979-10-18
LATEST ACTION
2009-03-13
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
CYCLOCORT · ReferenceDiscontinued
AMCINONIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
CYCLOCORT · ReferenceDiscontinued
AMCINONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
Approval history
2009-03-13Labeling · Supplement 4AP
2009-03-13Labeling · Supplement 1AP
1999-06-16Manufacturing (CMC) · Supplement 9 · standardAP
1998-09-24Manufacturing (CMC) · Supplement 8 · standardAP
1998-09-23Manufacturing (CMC) · Supplement 7 · standardAP
1998-09-23Manufacturing (CMC) · Supplement 6 · standardAP
1989-02-02Labeling · Supplement 5AP
1986-08-26Manufacturing (CMC) · Supplement 3 · standardAP
1985-05-09Manufacturing (CMC) · Supplement 2 · standardAP
1979-10-18Type 1 - New Molecular Entity · Original · standardAP
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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