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FDA NDA · NDA019824

LOPROX

Sponsor: EUROFARMA

APPLICATION
NDA019824
TYPE
NDA
ORIGINAL APPROVAL
1988-12-30
LATEST ACTION
2025-11-04
ROUTE
TOPICAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

LOPROX · ReferencePrescription
CICLOPIROX 0.77% · SUSPENSION · TOPICAL

Approval history

2025-11-04Labeling · Supplement 25 · standard — Letter ↗AP
2016-10-04Manufacturing (CMC) · Supplement 24AP
2013-06-28Labeling · Supplement 23 · standard — Letter ↗AP
2003-03-26Labeling · Supplement 8 · standard — Letter ↗AP
2003-03-26Labeling · Supplement 9 · standard — Label ↗AP
1998-06-09Manufacturing (CMC) · Supplement 7 · standardAP
1995-11-17Manufacturing (CMC) · Supplement 6 · standardAP
1995-02-23Labeling · Supplement 3AP
1990-09-11Manufacturing (CMC) · Supplement 2 · standardAP
1989-05-08Labeling · Supplement 1AP
1988-12-30Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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