2026-08-03 · status AP
Supplement 59
FDA action labels
Labeling-Package Insert
3 official documents
- Medication Guide ↗2026-08-11 · FDA document 86854
- Label ↗2026-08-11 · FDA document 86844
- Letter ↗2026-08-06 · FDA document 86819
Drugs@FDA application timeline
NDA021318
26 dated FDA-coded AP submissions from 2002-11-26 through 2026-08-03, connected to 29 source-defined action assignments and 36 official document links.
26Dated AP submissions
29Action assignments
36Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-07-24 · status AP
Supplement 57
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
1 official document
- Label ↗2024-07-26 · FDA document 79221
2021-09-07 · status AP
Supplement 56
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
2020-11-16 · status AP
Supplement 54
FDA action labels
Efficacy-Labeling Change With Clinical Data
4 official documents
- Review ↗2022-06-28 · FDA document 71471
- Medication Guide ↗2021-02-05 · FDA document 66106
- Label ↗2020-12-01 · FDA document 65268
- Letter ↗2020-12-01 · FDA document 65261
2020-04-06 · status AP
Supplement 53
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2019-10-03 · status AP
Supplement 52
FDA action labels
Labeling-Package Insert
2017-04-28 · status AP
Supplement 51
FDA action labels
REMS - MODIFIED - D-N-A
1 official document
- Letter ↗2017-05-02 · FDA document 48200
2015-11-23 · status AP
Supplement 44
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-09-12 · status AP
Supplement 41
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-08-13 · status AP
Supplement 40
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-04-11 · status AP
Supplement 39
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-03-05 · status AP
Supplement 37
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-01-24 · status AP
Supplement 38
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-08-30 · status AP
Supplement 36
FDA action labels
REMS-Modified
2013-08-02 · status AP
Supplement 35
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-03-13 · status AP
Supplement 33
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-02-15 · status AP
Supplement 32
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2012-03-13 · status AP
Supplement 27
FDA action labels
Labeling-Medication Guide
1 official document
- Letter ↗2012-03-15 · FDA document 27466
2011-08-10 · status AP
Supplement 26
FDA action labels
Labeling
1 official document
- Letter ↗2011-08-12 · FDA document 5016
2009-07-22 · status AP
Supplement 12
FDA action labels
Efficacy-New Indication · REMS-Proposal
2008-06-25 · status AP
Supplement 16
FDA action labels
Labeling-Package Insert
2008-02-28 · status AP
Supplement 15
FDA action labels
Labeling
2007-05-19 · status AP
Supplement 9
FDA action labels
Labeling
2004-09-03 · status AP
Supplement 4
FDA action labels
Labeling
2004-06-02 · status AP
Supplement 2
FDA action labels
Labeling
2002-11-26 · 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.