2022-09-16 · 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
ANDA076313
8 dated FDA-coded AP submissions from 2005-03-28 through 2022-09-16, connected to 11 source-defined action assignments and 1 official document links.
8Dated AP submissions
11Action assignments
1Official 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 19
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-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 12
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2013-01-02 · status AP
Supplement 8
FDA action labels
Labeling-Package Insert · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2009-03-03 · status AP
Supplement 3
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2005-03-28 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
1 official document
- Letter ↗2005-03-30 · FDA document 31109
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.