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FDA NDA · NDA020519

CICLOPIROX

Sponsor: ALVOGEN

APPLICATION
NDA020519
TYPE
NDA
ORIGINAL APPROVAL
1997-07-21
LATEST ACTION
2013-06-28
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

CICLOPIROX · ReferenceDiscontinued
CICLOPIROX 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · TOPICAL

Approval history

2013-06-28Labeling · Supplement 16 · standard — Label ↗AP
2003-03-26Labeling · Supplement 5 · standard — Letter ↗AP
2000-02-25Manufacturing (CMC) · Supplement 2 · standardAP
1999-12-10Manufacturing (CMC) · Supplement 3 · standardAP
1999-07-01Manufacturing (CMC) · Supplement 4 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 1 · standardAP
1997-07-21Type 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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