2021-06-02 · Class II · Terminated
D-0417-2021 · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Open attributed report →Drugs@FDA application timeline
NDA202811
20 dated FDA-coded AP submissions from 2012-08-30 through 2026-05-21, connected to 23 source-defined action assignments and 33 official document links.
20Dated AP submissions
23Action assignments
33Official documents
1Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Exact application-number connection
FDA enforcement reports
Newest first
Submission and document chronology
2026-05-21 · status AP
Supplement 23
FDA action labels
Efficacy-New Patient Population
2025-11-04 · status AP
Supplement 22
FDA action labels
Efficacy-New Patient Population
3 official documents
- Letter ↗2025-11-05 · FDA document 84071
- Medication Guide ↗2025-11-05 · FDA document 84065
- Label ↗2025-11-05 · FDA document 84064
2023-06-12 · status AP
Supplement 21
FDA action labels
Efficacy-New Indication
3 official documents
- Medication Guide ↗2023-06-13 · FDA document 74485
- Label ↗2023-06-13 · FDA document 74484
- Letter ↗2023-06-13 · FDA document 74482
2021-08-24 · status AP
Supplement 18
FDA action labels
Labeling-Medication Guide · Labeling-Patient Package Insert
2021-04-12 · status AP
Supplement 17
FDA action labels
Labeling-Package Insert
2020-09-22 · status AP
Supplement 16
FDA action labels
Efficacy-Labeling Change With Clinical Data
2017-03-08 · status AP
Supplement 13
FDA action labels
Labeling-Package Insert · Labeling-Patient Package Insert
2017-01-25 · status AP
Supplement 10
FDA action labels
Efficacy-New Dosing Regimen
2017-01-06 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2016-08-31 · status AP
Supplement 11
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2016-05-18 · status AP
Supplement 8
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2016-04-06 · status AP
Supplement 7
FDA action labels
Labeling-Package Insert
2015-11-23 · status AP
Supplement 9
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2015-01-05 · status AP
Supplement 6
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-12-11 · status AP
Supplement 1
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-07-09 · status AP
Supplement 4
FDA action labels
Labeling-Package Insert
2014-07-01 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-11-08 · status AP
Supplement 2
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-08-08 · status AP
Supplement 3
FDA action labels
Labeling-Medication Guide
2012-08-30 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
4 official documents
- Summary Review ↗2012-10-04 · FDA document 44867
- Review ↗2012-10-04 · FDA document 43414
- Letter ↗2012-08-31 · FDA document 32311
- Label ↗2012-08-31 · FDA document 19383
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.