2024-07-11 · status AP
Supplement 32
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA022074
20 dated FDA-coded AP submissions from 2007-08-30 through 2024-07-11, connected to 18 source-defined action assignments and 31 official document links.
20Dated AP submissions
18Action assignments
31Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2023-02-24 · status AP
Supplement 26
No source action-type assignment was retained for this submission.
2019-06-14 · status AP
Supplement 21
FDA action labels
Manufacturing (CMC)-Packaging
2019-04-11 · status AP
Supplement 24
FDA action labels
Labeling-Package Insert
2018-12-12 · status AP
Supplement 22
FDA action labels
Labeling-Package Insert
2018-02-22 · status AP
Supplement 18
FDA action labels
Labeling-Package Insert
2017-10-23 · status AP
Supplement 20
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2017-09-15 · status AP
Supplement 17
FDA action labels
Efficacy-New Indication
2015-12-11 · status AP
Supplement 15
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-11-02 · status AP
Supplement 14
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-06-01 · status AP
Supplement 13
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-06-01 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-12-22 · status AP
Supplement 10
FDA action labels
Labeling-Package Insert
2014-12-16 · status AP
Supplement 11
FDA action labels
Efficacy-New Indication
2014-10-28 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)
2014-10-23 · status AP
Supplement 9
FDA action labels
Manufacturing (CMC)
1 official document
- Review ↗2018-04-18 · FDA document 53728
2014-02-21 · status AP
Supplement 7
FDA action labels
Manufacturing (CMC)
1 official document
- Review ↗2022-10-19 · FDA document 72414
2013-11-27 · status AP
Supplement 6
FDA action labels
Labeling-Package Insert
2011-03-04 · status AP
Supplement 3
FDA action labels
Efficacy-New Dosing Regimen
2007-08-30 · 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.