Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Halozyme Therapeutics and its 2 subsidiaries with 4 drug applications, 2 complete response letters and 1 510(k) clearance. The most recent is a complete response letter dated Aug 16, 2024: Complete response letter, NDA 218026.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Halozyme Therapeutics and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 16, 2024 | Complete response letter, NDA 218026Unapproved | Complete response letters |
| Oct 20, 2017 | Complete response letter, NDA 209863Approved | Complete response letters |
| Apr 14, 2005 | CUMULASEK042495 · MQL | 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
