Eli Lilly
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.. FDA records under 12 spellings of its name, each linked to the record. See the Eli Lilly group view.
- Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 185, 8 entities
- Drug applications: 156
- 510(k) clearances: 11
- Complete response letters: 5
- Drug recalls: 5
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Eli Lilly and its 7 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Sep 9, 2025 | Warning letter: DrugsCDER | Warning letters |
| Sep 9, 2025 | Warning letter: DrugsCDER | Warning letters |
| Sep 9, 2025 | Warning letter: DrugsCDER | Warning letters |
| Sep 9, 2025 | Warning letter: Zepbound and MounjaroOffice of Prescription Drug Promotion | OPDP letters |
| Sep 9, 2025 | Warning letter: ZepboundOffice of Prescription Drug Promotion | OPDP letters |
| Sep 9, 2025 | Warning letter: ZEPBOUNDOffice of Prescription Drug Promotion | OPDP letters |
| Sep 28, 2023 | Complete response letter, BLA 761306Approved | Complete response letters |
| Mar 30, 2023 | Complete response letter, BLA 761279Approved | Complete response letters |
| Jan 18, 2023 | Complete response letter, BLA 761248Approved | Complete response letters |
| Sep 16, 2022 | Tempo Smart ButtonK212217 · QOG | 510(k) clearances |
| Jan 19, 2022 | Untitled letter: TRULICITYOffice of Prescription Drug Promotion | OPDP letters |
| Dec 17, 2021 | Complete response letter, BLA 761215/Original 2, BLA 761215Approved | Complete response letters |
| Dec 17, 2021 | Complete response letter, BLA 761215/Original 2, BLA 761215Approved | Complete response letters |
| Dec 13, 2021 | Untitled letter: EMGALITYOffice of Prescription Drug Promotion | OPDP letters |
| Nov 8, 2018 | ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subClass III · Labeling: Missing label; potential for missing primary container label on the vial. | Drug recalls |
| Dec 22, 2016 | Go Dose SystemK160949 · NDC | 510(k) clearances |
| Jun 3, 2016 | HumaPen SavvioK160668 · FMF | 510(k) clearances |
| Dec 30, 2015 | HumanPen Ergo IIK151686 · FMF | 510(k) clearances |
| Jun 5, 2015 | HumaPen LuxuraK142518 · FMF | 510(k) clearances |
| Aug 17, 2010 | HUMAPEN LUXURA HDK100988 · FMF | 510(k) clearances |
| Jan 9, 2007 | HUMAPEN LUXURA HDK063151 · NSC | 510(k) clearances |
| Apr 7, 2006 | HUMAPEN MEMOIRK053563 · FMF | 510(k) clearances |
Subsidiaries and Divisions
7 firms in the Eli Lilly group, most records first- Lilly116 records
- Dista Products8 records
- AVID Radiopharmaceuticals2 records
- Lilly Research Laboratories2 records
- ImClone Systems1 record
- Lilly Res Labs1 record
- Loxo Oncology1 record
Canada and Imports
Across the Eli Lilly group, matched by company nameNames and Identifiers
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