2026-05-06 · status AP
Supplement 57
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA021488
17 dated FDA-coded AP submissions from 2003-02-13 through 2026-05-06, connected to 16 source-defined action assignments and 35 official document links.
17Dated AP submissions
16Action assignments
35Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-02-24 · status AP
Supplement 53
FDA action labels
Labeling-Package Insert
2025-02-04 · status AP
Supplement 52
FDA action labels
Labeling-Container/Carton Labels
2024-05-21 · status AP
Supplement 50
FDA action labels
Labeling-Container/Carton Labels
2024-01-23 · status AP
Supplement 48
FDA action labels
Labeling-Package Insert
2023-07-20 · status AP
Supplement 45
FDA action labels
Efficacy-New Indication
2023-07-20 · status AP
Supplement 44
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-02-15 · status AP
Supplement 36
FDA action labels
Labeling-Package Insert
2016-02-29 · status AP
Supplement 30
FDA action labels
Labeling-Package Insert
2014-10-10 · status AP
Supplement 27
FDA action labels
Labeling-Package Insert
2013-02-27 · status AP
Supplement 25
FDA action labels
Labeling-Package Insert
2011-04-08 · status AP
Supplement 17
FDA action labels
Labeling-Package Insert
2011-01-14 · status AP
Supplement 16
FDA action labels
Labeling
2010-10-05 · status AP
Supplement 15
FDA action labels
Labeling-Package Insert
2007-11-08 · status AP
Supplement 10
FDA action labels
Labeling
2004-01-12 · status AP
Supplement 2
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-14 · FDA document 5523
2003-02-13 · 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 23667
- Letter ↗2004-06-03 · FDA document 27917
- Review ↗2003-05-08 · FDA document 21688
- Label ↗2003-02-13 · FDA document 37055
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.