2024-07-11 · status AP
Supplement 49
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA021008
29 dated FDA-coded AP submissions from 1998-11-25 through 2024-07-11, connected to 29 source-defined action assignments and 34 official document links.
29Dated AP submissions
29Action assignments
34Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-01-05 · status AP
Supplement 47
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
2023-02-09 · status AP
Supplement 46
FDA action labels
Manufacturing (CMC)-Facility
2021-03-30 · status AP
Supplement 41
FDA action labels
Labeling-Package Insert
2019-04-11 · status AP
Supplement 43
FDA action labels
Labeling-Package Insert
2018-12-21 · status AP
Supplement 36
FDA action labels
Labeling-Package Insert
2016-07-22 · status AP
Supplement 35
FDA action labels
Manufacturing (CMC)
1 official document
- Label ↗2016-07-25 · FDA document 35876
2016-05-20 · status AP
Supplement 34
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-05-18 · status AP
Supplement 33
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-08-21 · status AP
Supplement 32
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-07-17 · status AP
Supplement 30
FDA action labels
Manufacturing (CMC)
1 official document
- Label ↗2014-07-22 · FDA document 14155
2014-05-19 · status AP
Supplement 28
FDA action labels
Labeling-Package Insert
2014-01-30 · status AP
Supplement 29
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2012-11-30 · status AP
Supplement 27
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2011-09-30 · status AP
Supplement 25
FDA action labels
Labeling-Package Insert
2010-01-25 · status AP
Supplement 23
FDA action labels
Labeling
2008-03-03 · status AP
Supplement 21
FDA action labels
Efficacy-New Indication
2006-05-10 · status AP
Supplement 19
FDA action labels
Labeling
2006-05-10 · status AP
Supplement 18
FDA action labels
Efficacy-New Patient Population
2004-10-14 · status AP
Supplement 15
FDA action labels
Labeling
1 official document
- Letter ↗2004-10-18 · FDA document 4027
2004-04-19 · status AP
Supplement 10
FDA action labels
Manufacturing (CMC)-Control
2004-04-19 · status AP
Supplement 6
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2003-12-18 · status AP
Supplement 7
FDA action labels
Manufacturing (CMC)-Control
1 official document
- Letter ↗2003-12-23 · FDA document 26469
2002-05-13 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2002-01-03 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2001-07-02 · status AP
Supplement 3
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1999-07-13 · status AP
Supplement 2
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1999-05-17 · status AP
Supplement 1
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1998-11-25 · 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.