Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Liofilchem and its 1 subsidiaries with 39 510(k) clearances. The most recent is a 510(k) clearance dated Jul 23, 2026: Gepotidacin GEP 10 µg.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Liofilchem and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 23, 2026 | Gepotidacin GEP 10 µgK261853 · JTN | 510(k) clearances |
| Apr 17, 2026 | MTS Gepotidacin 0.016-256 µg/mLK260696 · JWY | 510(k) clearances |
| Oct 2, 2025 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLK252114 · JWY | 510(k) clearances |
| Aug 20, 2025 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)K251580 · JWY | 510(k) clearances |
| Aug 12, 2025 | Sulopenem SPM 2 µgK251879 · JTN | 510(k) clearances |
| Jun 23, 2025 | Ceftobiprole BPR 5 µg DiscK250885 · JTN | 510(k) clearances |
| Jan 30, 2025 | MTS Ceftobiprole 0.002-32 µg/mLK243202 · JWY | 510(k) clearances |
| May 18, 2023 | ComASP Cefiderocol 0.008-128K230479 · JWY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
