2024-11-06 · status AP
Supplement 6
FDA action labels
Labeling-Container/Carton 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
ANDA208569
2 dated FDA-coded AP submissions from 2023-11-16 through 2024-11-06, connected to 3 source-defined action assignments and 1 official document links.
2Dated AP submissions
3Action assignments
1Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2023-11-16 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
1 official document
- Letter ↗2023-12-14 · FDA document 76798
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.