← FDA DRUG APPROVALS

FDA NDA · NDA208945

XEPI

Sponsor: LNHC

APPLICATION
NDA208945
TYPE
NDA
ORIGINAL APPROVAL
2017-12-11
LATEST ACTION
2019-02-04
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

XEPI · ReferenceDiscontinued
OZENOXACIN 1% · CREAM · TOPICAL

Approval history

2019-02-04Labeling · Supplement 1 · standard — Label ↗AP
2017-12-11Type 1 - New Molecular Entity · Original · standard — Label ↗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 →