Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Seikagaku Corporation with 1 complete response letter and 1 510(k) clearance. The most recent is a complete response letter dated Mar 11, 2025: Complete response letter, BLA 761393.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 11, 2025 | Complete response letter, BLA 761393Unapproved | Complete response letters |
| Aug 15, 2001 | HADGEL, 4 GRAM/SYRINGEK011544 · LYA | 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
