2026-06-18 · status AP
Supplement 7
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
1 official document
- Label ↗2026-06-23 · FDA document 86340
Drugs@FDA application timeline
NDA218316
6 dated FDA-coded AP submissions from 2025-12-22 through 2026-06-18, connected to 9 source-defined action assignments and 11 official document links.
6Dated AP submissions
9Action assignments
11Official 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 3
FDA action labels
Labeling-Package Insert
1 official document
- Label ↗2026-05-12 · FDA document 85893
2026-03-19 · status AP
Supplement 5
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
3 official documents
- Medication Guide ↗2026-03-24 · FDA document 85516
- Label ↗2026-03-24 · FDA document 85500
- Letter ↗2026-03-23 · FDA document 85453
2026-02-25 · status AP
Supplement 4
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2026-01-29 · status AP
Supplement 2
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2025-12-22 · 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.