2025-05-28 · status AP
Supplement 25
FDA action labels
Labeling-Package Insert
3 official documents
- Medication Guide ↗2025-06-02 · FDA document 82387
- Label ↗2025-06-02 · FDA document 82386
- Letter ↗2025-05-29 · FDA document 82349
Drugs@FDA application timeline
NDA209210
18 dated FDA-coded AP submissions from 2017-10-20 through 2025-05-28, connected to 17 source-defined action assignments and 39 official document links.
18Dated AP submissions
17Action assignments
39Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-11-01 · status AP
Supplement 24
FDA action labels
Labeling-Package Insert
3 official documents
- Letter ↗2024-11-05 · FDA document 80126
- Medication Guide ↗2024-11-04 · FDA document 80108
- Label ↗2024-11-04 · FDA document 80107
2024-03-06 · status AP
Supplement 23
FDA action labels
Labeling-Package Insert
2022-12-21 · status AP
Supplement 22
FDA action labels
Labeling-Package Insert
2022-07-26 · status AP
Supplement 19
FDA action labels
Labeling-Package Insert
2022-06-10 · status AP
Supplement 21
FDA action labels
Labeling-Package Insert
2021-07-22 · status AP
Supplement 17
FDA action labels
Efficacy-New Indication
2020-12-02 · status AP
Supplement 14
FDA action labels
Labeling-Package Insert
2020-02-28 · status AP
Supplement 11
FDA action labels
Labeling-Package Insert
2019-07-25 · status AP
Supplement 8
FDA action labels
Labeling-Package Insert
2019-07-25 · status AP
Supplement 7
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-07-25 · status AP
Supplement 6
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-07-25 · status AP
Supplement 5
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-07-25 · status AP
Supplement 4
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-07-25 · status AP
Supplement 3
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-07-25 · status AP
Supplement 2
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-02-15 · status AP
Supplement 1
FDA action labels
Efficacy-Labeling Change With Clinical Data
2017-10-20 · 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.