2025-09-10 · status AP
Supplement 48
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA020011
37 dated FDA-coded AP submissions from 1990-10-22 through 2025-09-10, connected to 36 source-defined action assignments and 31 official document links.
37Dated AP submissions
36Action 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 47
FDA action labels
Labeling-Package Insert
2023-01-27 · status AP
Supplement 46
FDA action labels
Labeling-Package Insert
2021-02-12 · status AP
Supplement 42
FDA action labels
Labeling-Package Insert
2013-10-30 · status AP
Supplement 41
FDA action labels
Labeling-Patient Package Insert
2012-03-28 · status AP
Supplement 38
FDA action labels
Labeling
2012-01-23 · status AP
Supplement 40
FDA action labels
Labeling-Package Insert
2011-06-14 · status AP
Supplement 39
FDA action labels
Labeling-Package Insert
2010-10-29 · status AP
Supplement 37
FDA action labels
Labeling-Package Insert
2009-06-02 · status AP
Supplement 36
FDA action labels
Labeling
2007-10-31 · status AP
Supplement 33
FDA action labels
Labeling
1 official document
- Letter ↗2007-11-08 · FDA document 19935
2005-09-15 · status AP
Supplement 31
FDA action labels
Labeling
1 official document
- Letter ↗2005-10-20 · FDA document 1907
2005-09-15 · status AP
Supplement 29
FDA action labels
Manufacturing (CMC)-Control
1 official document
- Letter ↗2005-10-20 · FDA document 1906
2004-01-15 · status AP
Supplement 25
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-22 · FDA document 1905
2004-01-12 · status AP
Supplement 28
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-14 · FDA document 19934
2002-09-20 · status AP
Supplement 26
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 24
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 23
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 22
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-09-21 · status AP
Supplement 21
FDA action labels
Efficacy-New Indication
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.
1999-08-13 · status AP
Supplement 16
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1998-06-30 · status AP
Supplement 15
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1998-04-09 · status AP
Supplement 14
FDA action labels
Efficacy-New Indication
1997-06-27 · status AP
Supplement 11
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 10
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1995-10-26 · status AP
Supplement 6
FDA action labels
Manufacturing (CMC)-Packaging
No eligible official document row was listed for this submission in the retained archive.
1995-09-22 · status AP
Supplement 7
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 8
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1994-11-07 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1994-07-21 · status AP
Supplement 5
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1994-04-26 · status AP
Supplement 2
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1994-02-14 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)-Expiration Date
No eligible official document row was listed for this submission in the retained archive.
1990-10-22 · 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 44041
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.