2025-08-18 · status AP
Supplement 50
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA019732
39 dated FDA-coded AP submissions from 1989-01-26 through 2025-08-18, connected to 39 source-defined action assignments and 41 official document links.
39Dated AP submissions
39Action assignments
41Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-03-21 · status AP
Supplement 49
FDA action labels
Labeling-Package Insert
2023-12-04 · status AP
Supplement 48
FDA action labels
Labeling-Package Insert
2022-04-18 · status AP
Supplement 45
FDA action labels
Efficacy-New Indication
2019-03-04 · status AP
Supplement 44
FDA action labels
Labeling-Package Insert
2018-12-10 · status AP
Supplement 43
FDA action labels
Labeling-Package Insert
2016-06-06 · status AP
Supplement 42
FDA action labels
Labeling-Package Insert
2014-06-27 · status AP
Supplement 41
FDA action labels
Labeling-Package Insert
2013-07-10 · status AP
Supplement 40
FDA action labels
Labeling-Package Insert
2012-02-17 · status AP
Supplement 38
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
2011-01-14 · status AP
Supplement 37
FDA action labels
Labeling
2010-04-28 · status AP
Supplement 36
FDA action labels
Labeling
2010-04-28 · status AP
Supplement 35
FDA action labels
Labeling
2010-04-28 · status AP
Supplement 31
FDA action labels
Labeling
2005-09-15 · status AP
Supplement 29
FDA action labels
Labeling
2005-09-15 · status AP
Supplement 27
FDA action labels
Manufacturing (CMC)-Control
2004-01-12 · status AP
Supplement 26
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-14 · FDA document 19127
2003-09-09 · status AP
Supplement 23
FDA action labels
Labeling
1 official document
- Letter ↗2003-09-25 · FDA document 19126
2002-09-20 · status AP
Supplement 24
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 22
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 21
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-03-01 · status AP
Supplement 20
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-01-24 · status AP
Supplement 19
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 18
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 17
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1999-10-04 · status AP
Supplement 15
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1999-08-13 · status AP
Supplement 16
FDA action labels
Manufacturing (CMC)
1 official document
- Review ↗2006-10-26 · FDA document 20306
1998-06-30 · status AP
Supplement 14
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1998-01-09 · status AP
Supplement 12
FDA action labels
Labeling
1997-06-27 · status AP
Supplement 13
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1995-10-26 · status AP
Supplement 9
FDA action labels
Manufacturing (CMC)-Packaging
1 official document
- Review ↗2006-10-26 · FDA document 20304
1995-09-22 · status AP
Supplement 10
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 11
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1994-11-08 · status AP
Supplement 8
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1994-04-26 · status AP
Supplement 6
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1994-02-14 · status AP
Supplement 7
FDA action labels
Manufacturing (CMC)-Expiration Date
1 official document
- Review ↗2006-10-26 · FDA document 20303
1992-03-26 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1990-12-14 · status AP
Supplement 2
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1989-01-26 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
1 official document
- Other Important Information from FDA ↗2011-12-20 · FDA document 23552
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.