2025-09-02 · status AP
Supplement 51
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
Drugs@FDA application timeline
NDA021773
36 dated FDA-coded AP submissions from 2005-04-28 through 2025-09-02, connected to 38 source-defined action assignments and 62 official document links.
36Dated AP submissions
38Action assignments
62Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-05-28 · status AP
Supplement 50
FDA action labels
Labeling-Package Insert
3 official documents
- Medication Guide ↗2025-06-02 · FDA document 82382
- Label ↗2025-06-02 · FDA document 82381
- Letter ↗2025-05-29 · FDA document 82342
2024-11-01 · status AP
Supplement 49
FDA action labels
Labeling-Package Insert
2022-12-21 · status AP
Supplement 48
FDA action labels
Labeling-Package Insert
2022-06-10 · status AP
Supplement 47
FDA action labels
Labeling-Package Insert
2022-06-10 · status AP
Supplement 46
FDA action labels
Labeling-Container/Carton Labels
2021-11-04 · status AP
Supplement 45
FDA action labels
Efficacy-Labeling Change With Clinical Data
2021-06-17 · status AP
Supplement 44
FDA action labels
Labeling-Package Insert
2020-02-28 · status AP
Supplement 43
FDA action labels
Labeling-Package Insert
2018-12-20 · status AP
Supplement 41
FDA action labels
Labeling-Package Insert
1 official document
- Label ↗2018-12-21 · FDA document 56970
2015-02-25 · status AP
Supplement 40
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
2014-11-24 · status AP
Supplement 36
FDA action labels
Efficacy-Labeling Change With Clinical Data
2014-08-12 · status AP
Supplement 39
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-06-04 · status AP
Supplement 38
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-06-04 · status AP
Supplement 37
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-04-23 · status AP
Supplement 35
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-01-30 · status AP
Supplement 34
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2011-10-19 · status AP
Supplement 30
FDA action labels
Efficacy-Labeling Change With Clinical Data
2011-10-19 · status AP
Supplement 29
FDA action labels
Efficacy-Labeling Change With Clinical Data
2011-08-05 · status AP
Supplement 31
FDA action labels
REMS-Assessment
1 official document
- Letter ↗2011-08-10 · FDA document 6151
2010-11-12 · status AP
Supplement 28
FDA action labels
Labeling
2010-08-13 · status AP
Supplement 26
FDA action labels
Labeling-Container/Carton Labels
1 official document
- Letter ↗2010-08-20 · FDA document 28567
2009-10-30 · status AP
Supplement 25
FDA action labels
REMS-Proposal
2009-10-30 · status AP
Supplement 22
FDA action labels
Labeling
2009-10-30 · status AP
Supplement 18
FDA action labels
Labeling
2009-10-30 · status AP
Supplement 17
FDA action labels
Labeling
2009-10-30 · status AP
Supplement 11
FDA action labels
Labeling
2009-10-30 · status AP
Supplement 9
FDA action labels
Labeling
2008-06-17 · status AP
Supplement 10
FDA action labels
Labeling
2008-01-11 · status AP
Supplement 12
FDA action labels
Labeling
2007-02-10 · status AP
Supplement 7
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
2006-12-22 · status AP
Supplement 6
FDA action labels
Labeling
2006-12-22 · status AP
Supplement 2
FDA action labels
Efficacy-New Indication
2006-11-01 · status AP
Supplement 5
FDA action labels
Labeling
2006-10-12 · status AP
Supplement 4
FDA action labels
Labeling
2005-04-28 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
4 official documents
- Other Important Information from FDA ↗2009-11-02 · FDA document 44151
- Review ↗2005-08-04 · FDA document 42305
- Label ↗2005-05-03 · FDA document 37610
- Letter ↗2005-05-03 · FDA document 28558
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.