2024-07-03 · status AP
Supplement 4
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA209564
4 dated FDA-coded AP submissions from 2021-02-09 through 2024-07-03, connected to 6 source-defined action assignments and 1 official document links.
4Dated AP submissions
6Action assignments
1Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2022-05-18 · status AP
Supplement 2
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2022-05-18 · status AP
Supplement 1
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2021-02-09 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
1 official document
- Letter ↗2021-03-10 · FDA document 66714
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.