2024-10-25 · status AP
Supplement 2
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA216839
3 dated FDA-coded AP submissions from 2023-06-22 through 2024-10-25, connected to 2 source-defined action assignments and 0 official document links.
3Dated AP submissions
2Action assignments
0Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-06-14 · status AP
Supplement 1
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2023-06-22 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
No eligible official document row was listed for this submission in the retained archive.
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.