← FDA DRUG APPROVALS

FDA NDA · NDA206966

XEGLYZE

Sponsor: LNHC

APPLICATION
NDA206966
TYPE
NDA
ORIGINAL APPROVAL
2020-07-24
LATEST ACTION
2022-07-20
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

XEGLYZE · ReferenceDiscontinued
ABAMETAPIR 0.74% · LOTION · TOPICAL

Approval history

2022-07-20Labeling · Supplement 2 · standard — Letter ↗AP
2020-07-24Type 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 →