2021-01-26 · status AP
Supplement 60
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA020928
16 dated FDA-coded AP submissions from 1998-09-11 through 2021-01-26, connected to 17 source-defined action assignments and 12 official document links.
16Dated AP submissions
17Action assignments
12Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2018-12-20 · status AP
Supplement 57
FDA action labels
Labeling-Container/Carton Labels
1 official document
- Letter ↗2018-12-21 · FDA document 56965
2018-07-06 · status AP
Supplement 56
FDA action labels
Labeling-Package Insert
2018-04-18 · status AP
Supplement 55
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert · Labeling-Patient Package Insert
2015-12-18 · status AP
Supplement 51
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-07-21 · status AP
Supplement 50
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-08-11 · status AP
Supplement 49
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-03-27 · status AP
Supplement 48
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-09-27 · status AP
Supplement 47
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2004-02-24 · status AP
Supplement 10
FDA action labels
Labeling
2002-11-15 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2002-11-12 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2002-01-16 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-09-13 · status AP
Supplement 2
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1999-07-19 · status AP
Supplement 1
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1998-09-11 · 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.