2026-05-06 · status AP
Supplement 60
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA021343
25 dated FDA-coded AP submissions from 2002-01-23 through 2026-05-06, connected to 24 source-defined action assignments and 38 official document links.
25Dated AP submissions
24Action assignments
38Official 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 48
FDA action labels
Efficacy-New Indication
2023-07-20 · status AP
Supplement 47
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-02-15 · status AP
Supplement 39
FDA action labels
Labeling-Package Insert
2017-01-13 · status AP
Supplement 34
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2016-02-29 · status AP
Supplement 33
FDA action labels
Labeling-Package Insert
2015-10-26 · status AP
Supplement 32
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-10-10 · status AP
Supplement 31
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-10-10 · status AP
Supplement 30
FDA action labels
Labeling-Package Insert
2014-07-18 · status AP
Supplement 28
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-05-30 · status AP
Supplement 29
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-04-09 · status AP
Supplement 26
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 27
FDA action labels
Labeling-Package Insert
2011-04-08 · status AP
Supplement 20
FDA action labels
Labeling-Package Insert
2011-01-14 · status AP
Supplement 19
FDA action labels
Labeling
2010-10-05 · status AP
Supplement 18
FDA action labels
Labeling-Package Insert
2007-11-08 · status AP
Supplement 15
FDA action labels
Labeling
2004-01-12 · status AP
Supplement 4
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-14 · FDA document 27526
2003-07-03 · status AP
Supplement 2
FDA action labels
Labeling
1 official document
- Letter ↗2003-07-08 · FDA document 5090
2002-04-01 · status AP
Supplement 1
FDA action labels
Labeling
1 official document
- Letter ↗2002-04-01 · FDA document 5089
2002-01-23 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
4 official documents
- Other Important Information from FDA ↗2011-12-20 · FDA document 23647
- Label ↗2002-01-23 · FDA document 36695
- Letter ↗2002-01-23 · FDA document 27525
- Review ↗2002-01-23 · FDA document 21610
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.