2022-09-16 · status AP
Supplement 20
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA076330
7 dated FDA-coded AP submissions from 2005-04-08 through 2022-09-16, connected to 7 source-defined action assignments and 0 official document links.
7Dated AP submissions
7Action assignments
0Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2022-09-16 · status AP
Supplement 18
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2022-09-16 · status AP
Supplement 16
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2018-08-27 · status AP
Supplement 13
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2012-09-12 · status AP
Supplement 9
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2009-03-03 · status AP
Supplement 4
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2005-04-08 · 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.