2025-03-14 · status AP
Supplement 12
FDA action labels
Efficacy-New Indication
Drugs@FDA application timeline
NDA212097
6 dated FDA-coded AP submissions from 2019-09-10 through 2025-03-14, connected to 7 source-defined action assignments and 12 official document links.
6Dated AP submissions
7Action assignments
12Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2023-12-22 · status AP
Supplement 13
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert · Labeling-Patient Package Insert
2021-08-20 · status AP
Supplement 7
FDA action labels
Labeling-Package Insert
2021-07-15 · status AP
Supplement 8
FDA action labels
Labeling-Package Insert
2020-04-07 · status AP
Supplement 1
FDA action labels
Labeling-Container/Carton Labels
1 official document
- Letter ↗2020-04-08 · FDA document 62470
2019-09-10 · 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.