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. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GSK. FDA records under 9 spellings of its name, each linked to the record. See the GSK group view.
As of Nov 13, 2026, FDA's public records list GlaxoSmithKline LLC with 160 drug applications, 22 drug recalls, 2 complete response letters, 1 device recall and 1 OPDP letter. The most recent is a complete response letter dated Dec 16, 2025: Complete response letter, BLA 761458/Original 2, BLA 761458.
Drug applications: 160
Drug recalls: 22
Complete response letters: 2
Device recalls: 1
OPDP letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
52017Records5
120182018Records1vs 2017−4
12019Records1vs 2018+0
020202020Records0vs 2019−1
32021Records3vs 2020+3
120222022Records1vs 2021−2
32023Records3vs 2022+2
220242024Records2vs 2023−1
52025Records5vs 2024+3
220262026 to dateRecords2
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
