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FDA NDA · NDA018498

CYCLOCORT

Sponsor: ASTELLAS

APPLICATION
NDA018498
TYPE
NDA
ORIGINAL APPROVAL
1981-11-13
LATEST ACTION
2009-03-13
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

CYCLOCORT · ReferenceDiscontinued
AMCINONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

2009-03-13Labeling · Supplement 4AP
2002-09-03Labeling · Supplement 8 · standard — Letter ↗AP
1999-08-11Manufacturing (CMC) · Supplement 10 · standardAP
1999-06-16Manufacturing (CMC) · Supplement 11 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 9 · standardAP
1995-08-09Manufacturing (CMC) · Supplement 7 · standardAP
1991-11-29Manufacturing (CMC) · Supplement 6 · standardAP
1989-02-02Labeling · Supplement 5AP
1986-08-26Manufacturing (CMC) · Supplement 3 · standardAP
1985-05-09Manufacturing (CMC) · Supplement 2 · standardAP
1982-03-18Manufacturing (CMC) · Supplement 1 · standardAP
1981-11-13Type 3 - New Dosage Form · Original · standardAP
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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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