2021-07-20 · status AP
Supplement 56
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA020918
24 dated FDA-coded AP submissions from 1998-06-22 through 2021-07-20, connected to 26 source-defined action assignments and 28 official document links.
24Dated AP submissions
26Action assignments
28Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2021-03-11 · status AP
Supplement 54
FDA action labels
Labeling-Package Insert
2020-09-03 · status AP
Supplement 53
FDA action labels
Labeling-Package Insert
1 official document
- Letter ↗2020-09-17 · FDA document 64589
2018-07-06 · status AP
Supplement 52
FDA action labels
Labeling-Package Insert
1 official document
- Label ↗2018-07-09 · FDA document 54866
2018-04-18 · status AP
Supplement 49
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert · Labeling-Patient Package Insert
2016-02-11 · status AP
Supplement 47
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-12-10 · status AP
Supplement 43
FDA action labels
Labeling-Package Insert
2015-10-08 · status AP
Supplement 44
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-03-14 · status AP
Supplement 42
FDA action labels
Labeling-Container/Carton Labels
1 official document
- Letter ↗2014-03-19 · FDA document 3745
2013-04-26 · status AP
Supplement 40
FDA action labels
Labeling-Container/Carton Labels
1 official document
- Letter ↗2013-04-30 · FDA document 3744
2013-04-26 · status AP
Supplement 39
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-01-16 · status AP
Supplement 38
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2011-12-29 · status AP
Supplement 34
FDA action labels
Labeling-Package Insert
2010-12-15 · status AP
Supplement 30
FDA action labels
Labeling-Package Insert
2007-06-28 · status AP
Supplement 23
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2005-11-14 · status AP
Supplement 17
FDA action labels
Labeling
2004-12-23 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)-Packaging
2004-03-01 · status AP
Supplement 8
FDA action labels
Labeling
2002-08-05 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2002-07-11 · status AP
Supplement 3
FDA action labels
Labeling
2002-04-01 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2000-08-18 · status AP
Supplement 2
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2000-05-30 · status AP
Supplement 1
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1998-06-22 · 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.