2024-07-11 · status AP
Supplement 78
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA019667
50 dated FDA-coded AP submissions from 1988-10-21 through 2024-07-11, connected to 50 source-defined action assignments and 29 official document links.
50Dated AP submissions
50Action assignments
29Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2023-11-03 · status AP
Supplement 76
FDA action labels
Labeling-Package Insert · Labeling-Package Insert
2022-10-04 · status AP
Supplement 73
FDA action labels
Labeling-Package Insert
2021-10-20 · status AP
Supplement 71
FDA action labels
Labeling-Container/Carton Labels
2021-05-25 · status AP
Supplement 70
FDA action labels
Labeling-Package Insert
2019-04-11 · status AP
Supplement 67
FDA action labels
Labeling-Package Insert
2015-02-21 · status AP
Supplement 62
FDA action labels
Labeling-Container/Carton Labels
2014-02-04 · status AP
Supplement 59
FDA action labels
Manufacturing (CMC)
1 official document
- Letter ↗2014-02-11 · FDA document 1479
2012-03-23 · status AP
Supplement 61
FDA action labels
Labeling-Package Insert
2010-01-25 · status AP
Supplement 58
FDA action labels
Labeling
2008-08-26 · status AP
Supplement 54
FDA action labels
Labeling
2005-09-02 · status AP
Supplement 50
FDA action labels
Labeling
2003-02-10 · status AP
Supplement 42
FDA action labels
Manufacturing (CMC)
1 official document
- Letter ↗2003-02-10 · FDA document 17535
2003-01-17 · status AP
Supplement 44
FDA action labels
Manufacturing (CMC)
2002-07-24 · status AP
Supplement 32
FDA action labels
Labeling
1 official document
- Letter ↗2002-07-24 · FDA document 1474
2002-07-24 · status AP
Supplement 28
FDA action labels
Labeling
1 official document
- Letter ↗2002-07-24 · FDA document 17534
2002-05-28 · status AP
Supplement 43
FDA action labels
Manufacturing (CMC)-Packaging
No eligible official document row was listed for this submission in the retained archive.
2002-05-13 · status AP
Supplement 41
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 40
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 38
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-06-21 · status AP
Supplement 39
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1999-02-17 · status AP
Supplement 36
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1999-02-17 · status AP
Supplement 35
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1998-12-17 · status AP
Supplement 33
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1998-07-31 · status AP
Supplement 34
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1997-10-24 · status AP
Supplement 31
FDA action labels
Manufacturing (CMC)-Expiration Date
No eligible official document row was listed for this submission in the retained archive.
1997-10-24 · status AP
Supplement 30
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-10-24 · status AP
Supplement 29
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-10-24 · status AP
Supplement 27
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1996-10-21 · status AP
Supplement 26
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1996-08-14 · status AP
Supplement 25
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1996-07-16 · status AP
Supplement 24
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1996-06-12 · status AP
Supplement 23
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1996-02-16 · status AP
Supplement 22
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1995-12-18 · status AP
Supplement 20
FDA action labels
Manufacturing (CMC)-Formulation
No eligible official document row was listed for this submission in the retained archive.
1995-11-07 · status AP
Supplement 11
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1995-10-10 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1995-02-06 · status AP
Supplement 19
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1994-12-06 · status AP
Supplement 21
FDA action labels
Manufacturing (CMC)-Formulation
No eligible official document row was listed for this submission in the retained archive.
1994-05-03 · status AP
Supplement 17
FDA action labels
Efficacy-New Indication
No eligible official document row was listed for this submission in the retained archive.
1993-01-12 · status AP
Supplement 16
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1992-09-30 · status AP
Supplement 15
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1992-07-31 · status AP
Supplement 14
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1992-02-28 · status AP
Supplement 10
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1991-10-04 · status AP
Supplement 8
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1991-07-03 · status AP
Supplement 7
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1991-06-12 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)-Control
1 official document
- Review ↗1999-02-19 · FDA document 40962
1990-04-16 · status AP
Supplement 5
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1989-06-23 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1988-10-21 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
No eligible official document row was listed for this submission in the retained archive.
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.