2023-08-08 · status AP
Supplement 35
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA075957
8 dated FDA-coded AP submissions from 2005-10-03 through 2023-08-08, connected to 10 source-defined action assignments and 0 official document links.
8Dated AP submissions
10Action assignments
0Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2023-08-08 · status AP
Supplement 33
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.
2023-08-08 · status AP
Supplement 32
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2019-11-04 · status AP
Supplement 28
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2017-06-27 · status AP
Supplement 25
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2012-06-28 · status AP
Supplement 13
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2012-06-28 · status AP
Supplement 11
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2005-10-03 · 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.