2021-09-01 · Class II · Terminated
D-0773-2021 · Eli Lilly & Company
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Open attributed report →Drugs@FDA application timeline
BLA125469
22 dated FDA-coded AP submissions from 2014-09-18 through 2026-03-12, connected to 24 source-defined action assignments and 42 official document links.
22Dated AP submissions
24Action assignments
42Official documents
2Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Exact application-number connection
FDA enforcement reports
2022-05-25 · Class II · Completed
D-0884-2022 · Cardinal Health Inc.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Open attributed report →Newest first
Submission and document chronology
2026-03-12 · status AP
Supplement 65
FDA action labels
Labeling-Package Insert
3 official documents
- Label ↗2026-03-18 · FDA document 85385
- Letter ↗2026-03-16 · FDA document 85373
- Medication Guide ↗2026-03-12 · FDA document 85386
2025-05-28 · status AP
Supplement 63
FDA action labels
Labeling-Package Insert
2024-11-01 · status AP
Supplement 62
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
1 official document
- Label ↗2024-11-04 · FDA document 80116
2024-11-01 · status AP
Supplement 61
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2022-11-17 · status AP
Supplement 51
FDA action labels
Efficacy-New Patient Population
2022-06-10 · status AP
Supplement 52
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2022-06-10 · status AP
Supplement 46
FDA action labels
Labeling-Package Insert
2021-09-30 · status AP
Supplement 44
FDA action labels
Labeling-Package Insert
2020-09-03 · status AP
Supplement 36
FDA action labels
Efficacy-New Dosing Regimen
2020-02-21 · status AP
Supplement 33
FDA action labels
Efficacy-New Indication
2019-01-15 · status AP
Supplement 23
FDA action labels
Efficacy-Labeling Change With Clinical Data
2018-09-21 · status AP
Supplement 24
FDA action labels
Labeling-Package Insert
2018-06-29 · status AP
Supplement 17
FDA action labels
Efficacy-Accelerated Approval Confirmatory Study
2017-12-12 · status AP
Supplement 21
FDA action labels
REMS - MODIFIED - D-N-A
1 official document
- Letter ↗2017-12-18 · FDA document 50749
2017-08-01 · status AP
Supplement 13
FDA action labels
Labeling-Medication Guide
2017-08-01 · status AP
Supplement 11
FDA action labels
Labeling-Package Insert
2017-01-27 · status AP
Supplement 8
FDA action labels
Efficacy-Labeling Change With Clinical Data
2017-01-27 · status AP
Supplement 7
FDA action labels
Efficacy-New Indication
2015-07-27 · status AP
Supplement 4
FDA action labels
REMS-Modified
1 official document
- Letter ↗2015-07-28 · FDA document 9762
2015-03-09 · status AP
Supplement 1
FDA action labels
Labeling-Package Insert
1 official document
- Letter ↗2015-03-11 · FDA document 31973
2014-12-19 · status AP
Supplement 2
FDA action labels
Labeling-Package Insert
1 official document
- Letter ↗2014-12-24 · FDA document 31974
2014-09-18 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
4 official documents
- Label ↗2015-04-01 · FDA document 18917
- Summary Review ↗2014-10-27 · FDA document 44809
- Review ↗2014-10-27 · FDA document 22812
- Letter ↗2014-09-19 · FDA document 9761
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.