2026-06-18 · status AP
Supplement 25
FDA action labels
Manufacturing (CMC)-Manufacturing Process
1 official document
- Label ↗2026-06-23 · FDA document 86339
Drugs@FDA application timeline
NDA215256
16 dated FDA-coded AP submissions from 2021-06-04 through 2026-06-18, connected to 19 source-defined action assignments and 33 official document links.
16Dated AP submissions
19Action assignments
33Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2026-05-05 · status AP
Supplement 31
FDA action labels
Manufacturing (CMC)-Packaging
2026-03-19 · status AP
Supplement 29
FDA action labels
Efficacy-New Dosing Regimen
3 official documents
- Medication Guide ↗2026-03-24 · FDA document 85515
- Label ↗2026-03-24 · FDA document 85499
- Letter ↗2026-03-23 · FDA document 85452
2026-02-25 · status AP
Supplement 33
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2026-01-29 · status AP
Supplement 30
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2025-11-21 · status AP
Supplement 23
FDA action labels
Efficacy-New Indication
2025-10-14 · status AP
Supplement 26
FDA action labels
Labeling-Package Insert
2025-08-15 · status AP
Supplement 24
FDA action labels
Efficacy-New Indication
2024-11-27 · status AP
Supplement 15
FDA action labels
Efficacy-New Dosing Regimen
2024-11-01 · status AP
Supplement 21
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2024-03-08 · status AP
Supplement 11
FDA action labels
Efficacy-New Indication
2023-07-21 · status AP
Supplement 7
FDA action labels
Efficacy-New Dosing Regimen
2023-02-14 · status AP
Supplement 6
FDA action labels
Labeling-Container/Carton Labels · Labeling-Medication Guide
2022-12-23 · status AP
Supplement 5
FDA action labels
Efficacy-New Patient Population
2022-08-24 · status AP
Supplement 3
FDA action labels
Labeling-Package Insert
1 official document
- Label ↗2022-08-29 · FDA document 71941
2021-06-04 · 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.