2026-05-06 · status AP
Supplement 62
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA021731
20 dated FDA-coded AP submissions from 2004-12-14 through 2026-05-06, connected to 19 source-defined action assignments and 33 official document links.
20Dated AP submissions
19Action assignments
33Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-02-24 · status AP
Supplement 56
FDA action labels
Labeling-Package Insert
2025-02-04 · status AP
Supplement 55
FDA action labels
Labeling-Container/Carton Labels
2024-05-21 · status AP
Supplement 52
FDA action labels
Labeling-Container/Carton Labels
2024-01-23 · status AP
Supplement 51
FDA action labels
Labeling-Package Insert
2023-07-20 · status AP
Supplement 47
FDA action labels
Efficacy-New Indication
2023-07-20 · status AP
Supplement 44
FDA action labels
Efficacy-Labeling Change With Clinical Data
2022-11-25 · status AP
Supplement 43
No source action-type assignment was retained for this submission.
No eligible official document row was listed for this submission in the retained archive.
2019-02-15 · status AP
Supplement 37
FDA action labels
Labeling-Package Insert
2016-02-29 · status AP
Supplement 29
FDA action labels
Labeling-Package Insert
2014-10-10 · status AP
Supplement 27
FDA action labels
Labeling-Package Insert
2014-07-18 · status AP
Supplement 24
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-04-03 · status AP
Supplement 22
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-02-27 · status AP
Supplement 23
FDA action labels
Labeling-Package Insert
2011-04-08 · status AP
Supplement 13
FDA action labels
Labeling-Package Insert
2011-01-14 · status AP
Supplement 12
FDA action labels
Labeling
2010-10-05 · status AP
Supplement 10
FDA action labels
Labeling-Package Insert
2007-11-08 · status AP
Supplement 5
FDA action labels
Labeling
2006-09-29 · status AP
Supplement 4
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
1 official document
- Letter ↗2006-10-05 · FDA document 28487
2004-12-14 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
2 official documents
- Other Important Information from FDA ↗2011-12-20 · FDA document 23674
- Review ↗2006-09-27 · FDA document 21796
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.