Nu Eyne Co., Ltd. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
ADDNOX (BPSPM1)510(k)Jan 16, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 16, 2025
ELEXIR 2.0 (ALLIVE3)510(k)Nov 6, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 6, 2024
SMILE510(k)Feb 12, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 12, 2023
Elexir510(k)Jul 30, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 30, 2021