2026-05-06 · status AP
Supplement 40
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA078885
11 dated FDA-coded AP submissions from 2009-03-09 through 2026-05-06, connected to 12 source-defined action assignments and 0 official document links.
11Dated AP submissions
12Action assignments
0Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-09-23 · status AP
Supplement 39
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2025-09-19 · status AP
Supplement 32
FDA action labels
Labeling-Package Insert · Labeling-Patient Package Insert
No eligible official document row was listed for this submission in the retained archive.
2020-11-20 · status AP
Supplement 25
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2020-11-20 · status AP
Supplement 17
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2017-05-19 · status AP
Supplement 15
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2017-05-19 · status AP
Supplement 14
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2015-05-08 · status AP
Supplement 12
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2011-04-26 · status AP
Supplement 5
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2011-03-28 · status AP
Supplement 3
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2009-03-09 · 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.