Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 2 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Sumitomo Pharma and its 2 subsidiaries with 7 drug applications and 1 complete response letter. The most recent is a complete response letter dated Jan 29, 2019: Complete response letter, NDA 210875.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 8, 3 entities
Drug applications: 7
Complete response letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sumitomo Pharma and its 2 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
12017Records1
020182018Records0vs 2017−1
12019Records1vs 2018+1
320202020Records3vs 2019+2
12021Records1vs 2020−2
020222022Records0vs 2021−1
02023Records0vs 2022+0
020242024Records0vs 2023+0
02025Records0vs 2024+0
020262026 to dateRecords0
Latest Records
Newest first across sources; each opens the record
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
