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FDA NDA · NDA021022

PENLAC

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APPLICATION
NDA021022
TYPE
NDA
ORIGINAL APPROVAL
1999-12-17
LATEST ACTION
2004-12-03
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PENLAC · ReferenceDiscontinued
CICLOPIROX 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL

Approval history

2004-12-03Labeling · Supplement 4 · standard — Label ↗AP
2003-12-22Labeling · Supplement 3 · standard — Letter ↗AP
2003-06-09Labeling · Supplement 2 · standard — Label ↗AP
2001-02-09Manufacturing (CMC) · Supplement 1 · standardAP
1999-12-17Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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