← FDA DRUG APPROVALS

FDA NDA · NDA021159

LOPROX

Sponsor: BAUSCH

APPLICATION
NDA021159
TYPE
NDA
ORIGINAL APPROVAL
2003-02-28
LATEST ACTION
2016-04-07
ROUTE
TOPICAL
DOSAGE FORM
SHAMPOO
MARKETING STATUS
Discontinued

Products

LOPROX · ReferenceDiscontinued
CICLOPIROX 1% · SHAMPOO · TOPICAL

Approval history

2016-04-07Manufacturing (CMC) · Supplement 22 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 21 · standardAP
2013-05-08Labeling · Supplement 20 · standard — Label ↗AP
2012-12-06Labeling · Supplement 19 · unknown — Letter ↗AP
2006-06-12Labeling · Supplement 9 · standard — Label ↗AP
2004-02-26Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2003-02-28Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →