2021-06-02 · Class II · Terminated
D-0536-2021 · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Open attributed report →Drugs@FDA application timeline
NDA213051
13 dated FDA-coded AP submissions from 2019-09-20 through 2026-01-30, connected to 18 source-defined action assignments and 28 official document links.
13Dated AP submissions
18Action assignments
28Official 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
2026-01-30 · status AP
Supplement 30
FDA action labels
Labeling-Container/Carton Labels · Labeling-Medication Guide · Labeling-Package Insert
2025-10-17 · status AP
Supplement 29
FDA action labels
Labeling-Package Insert
2025-10-17 · status AP
Supplement 28
FDA action labels
Labeling-Package Insert
2025-10-17 · status AP
Supplement 24
FDA action labels
Efficacy-New Indication
4 official documents
- Letter ↗2025-10-21 · FDA document 83855
- Letter ↗2025-10-21 · FDA document 83854
- Medication Guide ↗2025-10-20 · FDA document 83829
- Label ↗2025-10-20 · FDA document 83828
2024-12-09 · status AP
Supplement 21
FDA action labels
Labeling-Package Insert
2024-12-09 · status AP
Supplement 20
FDA action labels
Efficacy-New Dosing Regimen
2024-11-01 · status AP
Supplement 23
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2024-01-24 · status AP
Supplement 18
FDA action labels
Labeling-Package Insert
2023-01-12 · status AP
Supplement 12
FDA action labels
Labeling-Package Insert
2022-06-10 · status AP
Supplement 11
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2021-04-30 · status AP
Supplement 6
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
1 official document
- Label ↗2021-05-05 · FDA document 67412
2020-01-16 · status AP
Supplement 1
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2019-09-20 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.