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FDA NDA · NDA018748

LOPROX

Sponsor: EUROFARMA

APPLICATION
NDA018748
TYPE
NDA
ORIGINAL APPROVAL
1982-12-30
LATEST ACTION
2025-11-04
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

LOPROX · ReferencePrescription
CICLOPIROX 0.77% · CREAM · TOPICAL

Approval history

2025-11-04Labeling · Supplement 26 · standard — Letter ↗AP
2016-01-13Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2013-06-28Labeling · Supplement 24 · standard — Letter ↗AP
2003-03-26Labeling · Supplement 10 · standard — Label ↗AP
2001-08-17Manufacturing (CMC) · Supplement 11 · standard — Label ↗AP
1998-09-15Manufacturing (CMC) · Supplement 8 · standardAP
1995-02-23Labeling · Supplement 5AP
1989-04-26Manufacturing (CMC) · Supplement 4 · standardAP
1986-05-29Manufacturing (CMC) · Supplement 3 · standardAP
1985-01-16Labeling · Supplement 1AP
1982-12-30Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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