2011-01-14 · status AP
Supplement 25
FDA action labels
Labeling
Drugs@FDA application timeline
NDA021088
18 dated FDA-coded AP submissions from 2000-03-03 through 2011-01-14, connected to 17 source-defined action assignments and 11 official document links.
18Dated AP submissions
17Action assignments
11Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2005-09-15 · status AP
Supplement 22
FDA action labels
Labeling
2005-09-08 · status AP
Supplement 7
FDA action labels
Labeling
2003-08-01 · status AP
Supplement 15
FDA action labels
Labeling
1 official document
- Letter ↗2003-08-15 · FDA document 26752
2002-10-21 · status AP
Supplement 16
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2002-08-23 · status AP
Supplement 13
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 14
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 12
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2002-05-17 · status AP
Supplement 11
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-08-13 · status AP
Supplement 8
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-08-08 · status AP
Supplement 9
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2001-07-05 · status AP
Supplement 6
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-06-08 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2001-01-24 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2000-10-16 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2000-09-28 · status AP
Supplement 2
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2000-09-18 · status AP
Supplement 1
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2000-03-03 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
4 official documents
- Other Important Information from FDA ↗2011-12-20 · FDA document 44095
- Label ↗2000-03-03 · FDA document 36102
- Letter ↗2000-03-03 · FDA document 26750
- Review ↗2000-03-03 · FDA document 21445
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.