2025-09-10 · status AP
Supplement 41
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA019943
32 dated FDA-coded AP submissions from 1995-03-30 through 2025-09-10, connected to 31 source-defined action assignments and 31 official document links.
32Dated AP submissions
31Action assignments
31Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-09-10 · status AP
Supplement 40
FDA action labels
Labeling-Package Insert
2023-01-27 · status AP
Supplement 39
FDA action labels
Labeling-Package Insert
2021-02-12 · status AP
Supplement 35
FDA action labels
Labeling-Package Insert
2013-10-30 · status AP
Supplement 34
FDA action labels
Labeling-Patient Package Insert
2012-03-28 · status AP
Supplement 31
FDA action labels
Labeling-Package Insert
2012-01-23 · status AP
Supplement 33
FDA action labels
Labeling-Package Insert
2011-06-14 · status AP
Supplement 32
FDA action labels
Labeling-Package Insert
2010-10-29 · status AP
Supplement 30
FDA action labels
Labeling-Package Insert
2009-06-02 · status AP
Supplement 29
FDA action labels
Labeling
2007-10-31 · status AP
Supplement 26
FDA action labels
Labeling
1 official document
- Letter ↗2007-11-08 · FDA document 1830
2005-09-15 · status AP
Supplement 24
FDA action labels
Labeling
2005-09-15 · status AP
Supplement 22
FDA action labels
Manufacturing (CMC)-Control
2004-01-15 · status AP
Supplement 18
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-22 · FDA document 19859
2004-01-12 · status AP
Supplement 21
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-14 · FDA document 19860
2002-09-20 · status AP
Supplement 19
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2002-05-23 · status AP
Supplement 17
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2002-02-21 · status AP
Supplement 16
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-11-14 · status AP
Supplement 15
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-03-01 · status AP
Supplement 14
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-01-24 · status AP
Supplement 13
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2000-05-12 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2000-05-11 · status AP
Supplement 11
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1999-08-13 · status AP
Supplement 10
FDA action labels
Manufacturing (CMC)
1 official document
- Review ↗2007-07-09 · FDA document 41105
1998-06-30 · status AP
Supplement 9
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-06-27 · status AP
Supplement 7
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1996-09-12 · status AP
Supplement 6
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1995-12-12 · status AP
Supplement 2
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1995-10-26 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)-Packaging
1 official document
- Review ↗2007-07-09 · FDA document 41104
1995-09-22 · status AP
Supplement 1
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1995-08-11 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1995-03-30 · 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 44040
- Review ↗2007-07-09 · FDA document 20430
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.