2023-03-16 · status AP
Supplement 12
FDA action labels
Labeling-Package Insert
1 official document
- Label ↗2023-05-04 · FDA document 74178
Drugs@FDA application timeline
NDA021060
6 dated FDA-coded AP submissions from 2004-12-28 through 2023-03-16, connected to 5 source-defined action assignments and 10 official document links.
6Dated AP submissions
5Action assignments
10Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2012-12-19 · status AP
Supplement 10
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2011-09-01 · status AP
Supplement 6
FDA action labels
Labeling-Patient Package Insert
2007-04-18 · status AP
Supplement 3
FDA action labels
Labeling
2005-05-26 · status AP
Supplement 1
FDA action labels
Labeling
2004-12-28 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.