Liofilchem s.r.l. FDA Approvals

0 new drug approvals and 6 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
MTS Gepotidacin 0.016-256 µg/mL510(k)Apr 17, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 17, 2026
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL510(k)Oct 2, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 2, 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)510(k)Aug 20, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 20, 2025
MTS Ceftobiprole 0.002-32 µg/mL510(k)Jan 30, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 30, 2025
ComASP Cefiderocol 0.008-128510(k)May 18, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	May 18, 2023
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL510(k)Oct 20, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 20, 2021