Laboratorios Biogalenic S.A. DE C.V. FDA Approvals

0 new drug approvals and 3 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
Laboratorios Biogalenic Sterile Water for Inhalation, USP510(k)Jan 14, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 14, 2026
Sterile Water USP and Sterile 0.9% Normal Saline USP510(k)Mar 6, 2025	—	510(k)Substantially Equivalent (Traditional)	Mar 6, 2025
Laboratorios Biogalenic Sterile Water for Inhalation, USP510(k)Jan 30, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 30, 2025