2024-07-09 · status AP
Supplement 6
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA203765
5 dated FDA-coded AP submissions from 2018-09-07 through 2024-07-09, connected to 5 source-defined action assignments and 0 official document links.
5Dated AP submissions
5Action assignments
0Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2023-02-21 · status AP
Supplement 3
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2023-02-21 · status AP
Supplement 2
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2020-02-03 · status AP
Supplement 1
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2018-09-07 · 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.