Drugs@FDA application timeline
NDA214938
3 dated FDA-coded AP submissions from 2021-11-19 through 2024-11-04, connected to 2 source-defined action assignments and 8 official document links.
3Dated AP submissions
2Action assignments
8Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-11-04 · status AP
Supplement 4
FDA action labels
Labeling-Package Insert
2 official documents
- Letter ↗2024-11-05 · FDA document 80175
- Label ↗2024-11-05 · FDA document 80147
2023-10-20 · status AP
Supplement 2
FDA action labels
Efficacy-New Patient Population
3 official documents
- Review ↗2025-04-10 · FDA document 81918
- Letter ↗2023-10-24 · FDA document 75892
- Label ↗2023-10-23 · FDA document 75887
2021-11-19 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
3 official documents
- Review ↗2021-12-22 · FDA document 69747
- Letter ↗2021-11-23 · FDA document 69385
- Label ↗2021-11-22 · FDA document 69366
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.