2026-03-12 · status AP
Supplement 12
FDA action labels
Labeling-Package Insert
3 official documents
- Label ↗2026-03-18 · FDA document 85387
- Letter ↗2026-03-16 · FDA document 85374
- Medication Guide ↗2026-03-12 · FDA document 85388
Drugs@FDA application timeline
BLA208471
7 dated FDA-coded AP submissions from 2016-07-27 through 2026-03-12, connected to 7 source-defined action assignments and 16 official document links.
7Dated AP submissions
7Action assignments
16Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-05-28 · status AP
Supplement 10
FDA action labels
Labeling-Package Insert
2024-11-01 · status AP
Supplement 9
FDA action labels
Labeling-Package Insert
2023-09-28 · status AP
Supplement 7
FDA action labels
Labeling-Package Insert
2022-06-10 · status AP
Supplement 5
FDA action labels
Labeling-Package Insert · Labeling-Patient Package Insert
2021-07-30 · status AP
Supplement 4
FDA action labels
Efficacy-Labeling Change With Clinical Data
2016-07-27 · 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.