← FDA DRUG APPROVALS

FDA NDA · NDA202736

SKLICE

ivermectin

Sponsor: ARBOR PHARMS LLC

APPLICATION
NDA202736
TYPE
NDA
ORIGINAL APPROVAL
2012-02-07
LATEST ACTION
2021-05-28
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Over-the-counter

Products

SKLICE · ReferenceOver-the-counter
IVERMECTIN 0.5% · LOTION · TOPICAL

Approval history

2021-05-28Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2020-10-27Efficacy · Supplement 6 · standard — Label ↗AP
2017-06-16Labeling · Supplement 3 · standard — Label ↗AP
2012-02-07Type 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 →