2025-07-30 · status AP
Supplement 24
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
Drugs@FDA application timeline
NDA201849
8 dated FDA-coded AP submissions from 2015-05-08 through 2025-07-30, connected to 9 source-defined action assignments and 12 official document links.
8Dated AP submissions
9Action assignments
12Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2022-07-14 · status AP
Supplement 13
FDA action labels
Labeling-Package Insert · Labeling-Patient Package Insert
2021-07-29 · status AP
Supplement 9
FDA action labels
Labeling-Package Insert
2019-09-09 · status AP
Supplement 5
FDA action labels
Efficacy-New Indication
2015-12-01 · status AP
Supplement 2
FDA action labels
Labeling-Package Insert
2015-11-03 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-11-03 · status AP
Supplement 1
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-05-08 · 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.