2026-06-01 · status AP
Supplement 38
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA209637
14 dated FDA-coded AP submissions from 2017-12-05 through 2026-06-01, connected to 16 source-defined action assignments and 33 official document links.
14Dated AP submissions
16Action assignments
33Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-10-14 · status AP
Supplement 37
FDA action labels
Labeling-Package Insert
4 official documents
- Review ↗2026-02-24 · FDA document 85146
- Medication Guide ↗2025-10-15 · FDA document 83783
- Label ↗2025-10-15 · FDA document 83782
- Letter ↗2025-10-15 · FDA document 83776
2025-10-14 · status AP
Supplement 35
FDA action labels
Labeling-Package Insert
2025-01-28 · status AP
Supplement 25
FDA action labels
Efficacy-New Indication
2024-11-01 · status AP
Supplement 32
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2023-09-22 · status AP
Supplement 21
FDA action labels
Labeling-Package Insert
2023-09-22 · status AP
Supplement 20
FDA action labels
Labeling-Package Insert
2022-10-06 · status AP
Supplement 12
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
2022-03-28 · status AP
Supplement 9
FDA action labels
Efficacy-New Dosing Regimen
2021-04-12 · status AP
Supplement 8
FDA action labels
Labeling-Package Insert
2020-01-16 · status AP
Supplement 3
FDA action labels
Efficacy-New Indication
2019-11-27 · status AP
Supplement 4
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
2019-04-09 · status AP
Supplement 1
FDA action labels
Labeling-Container/Carton Labels
2017-12-05 · 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.