2024-09-25 · status AP
Supplement 21
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA077450
10 dated FDA-coded AP submissions from 2006-02-10 through 2024-09-25, connected to 11 source-defined action assignments and 0 official document links.
10Dated AP submissions
11Action assignments
0Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-09-25 · status AP
Supplement 18
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2023-06-30 · status AP
Supplement 16
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2023-06-30 · status AP
Supplement 14
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2023-06-30 · status AP
Supplement 13
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2023-06-30 · status AP
Supplement 9
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2018-03-09 · status AP
Supplement 8
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2018-03-09 · status AP
Supplement 6
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2012-11-30 · status AP
Supplement 5
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2006-02-10 · 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.