Drugs@FDA application timeline
NDA213224
1 dated FDA-coded AP submissions from 2024-09-27 through 2024-09-27, connected to 0 source-defined action assignments and 3 official document links.
1Dated AP submissions
0Action assignments
3Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
1 submissions2024-09-27 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
3 official documents
- Review ↗2025-08-12 · FDA document 83095
- Label ↗2024-10-01 · FDA document 79785
- Letter ↗2024-09-30 · FDA document 79780
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.