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FDA NDA · NDA019729

CYCLOCORT

Sponsor: ASTELLAS

APPLICATION
NDA019729
TYPE
NDA
ORIGINAL APPROVAL
1988-06-13
LATEST ACTION
2001-01-19
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

CYCLOCORT · ReferenceDiscontinued
AMCINONIDE 0.1% · LOTION · TOPICAL

Approval history

2001-01-19Manufacturing (CMC) · Supplement 7 · standardAP
1998-09-23Manufacturing (CMC) · Supplement 6 · standardAP
1998-09-23Manufacturing (CMC) · Supplement 5 · standardAP
1991-11-22Manufacturing (CMC) · Supplement 4 · standardAP
1989-02-02Labeling · Supplement 3AP
1988-09-30Labeling · Supplement 2AP
1988-07-13Manufacturing (CMC) · Supplement 1 · standardAP
1988-06-13Type 3 - New Dosage Form · Original · standardReviewAP
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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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