2025-05-28 · status AP
Supplement 36
FDA action labels
Labeling-Package Insert
3 official documents
- Medication Guide ↗2025-06-02 · FDA document 82384
- Label ↗2025-06-02 · FDA document 82383
- Letter ↗2025-05-29 · FDA document 82343
Drugs@FDA application timeline
NDA022200
31 dated FDA-coded AP submissions from 2012-01-27 through 2025-05-28, connected to 31 source-defined action assignments and 47 official document links.
31Dated AP submissions
31Action assignments
47Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-11-01 · status AP
Supplement 35
FDA action labels
Labeling-Package Insert
2022-12-21 · status AP
Supplement 34
FDA action labels
Labeling-Package Insert
2022-07-26 · status AP
Supplement 32
FDA action labels
Labeling-Package Insert
2022-06-10 · status AP
Supplement 33
FDA action labels
Labeling-Package Insert
2021-07-22 · status AP
Supplement 31
FDA action labels
Efficacy-New Indication
2020-02-28 · status AP
Supplement 30
FDA action labels
Labeling-Package Insert
2019-02-15 · status AP
Supplement 28
FDA action labels
Efficacy-Labeling Change With Clinical Data
2018-04-02 · status AP
Supplement 26
FDA action labels
Efficacy-Labeling Change With Clinical Data
2017-10-20 · status AP
Supplement 25
FDA action labels
Efficacy-Labeling Change With Clinical Data
2016-06-10 · status AP
Supplement 24
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2016-01-11 · status AP
Supplement 23
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-12-31 · status AP
Supplement 21
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-12-23 · status AP
Supplement 22
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-09-24 · status AP
Supplement 18
FDA action labels
Efficacy-Labeling Change With Clinical Data
2015-09-24 · status AP
Supplement 17
FDA action labels
Efficacy-Labeling Change With Clinical Data
2015-09-24 · status AP
Supplement 16
FDA action labels
Efficacy-Labeling Change With Clinical Data
2015-09-24 · status AP
Supplement 15
FDA action labels
Efficacy-Labeling Change With Clinical Data
2015-09-18 · status AP
Supplement 20
FDA action labels
Labeling-Container/Carton Labels
2015-08-14 · status AP
Supplement 11
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2015-04-29 · status AP
Supplement 10
FDA action labels
REMS-Assessment · REMS-Modified
1 official document
- Letter ↗2015-05-05 · FDA document 7031
2015-03-09 · status AP
Supplement 19
FDA action labels
Labeling-Package Insert
2015-03-05 · status AP
Supplement 14
FDA action labels
Manufacturing (CMC)
2014-05-22 · status AP
Supplement 13
FDA action labels
Labeling-Package Insert
2014-05-22 · status AP
Supplement 12
FDA action labels
Labeling-Package Insert
2014-03-24 · status AP
Supplement 9
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-02-28 · status AP
Supplement 8
FDA action labels
Labeling-Package Insert
2014-02-28 · status AP
Supplement 7
FDA action labels
Labeling-Proprietary Name Change
No eligible official document row was listed for this submission in the retained archive.
2013-06-12 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-02-27 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2012-01-27 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
4 official documents
- Summary Review ↗2012-06-12 · FDA document 44698
- Review ↗2012-06-12 · FDA document 42445
- Label ↗2012-01-27 · FDA document 17070
- Letter ↗2012-01-27 · FDA document 7029
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.