2021-04-13 · status AP
Supplement 11
FDA action labels
Labeling-Package Insert
3 official documents
- Medication Guide ↗2021-04-16 · FDA document 67083
- Label ↗2021-04-16 · FDA document 67082
- Letter ↗2021-04-14 · FDA document 67054
Drugs@FDA application timeline
NDA208745
6 dated FDA-coded AP submissions from 2017-01-19 through 2021-04-13, connected to 6 source-defined action assignments and 15 official document links.
6Dated AP submissions
6Action assignments
15Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2021-02-10 · status AP
Supplement 7
FDA action labels
Labeling-Package Insert
3 official documents
- Medication Guide ↗2021-02-17 · FDA document 66247
- Label ↗2021-02-17 · FDA document 66246
- Letter ↗2021-02-11 · FDA document 66196
2020-10-29 · status AP
Supplement 10
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2018-07-25 · status AP
Supplement 2
FDA action labels
Labeling-Package Insert
2018-01-24 · status AP
Supplement 1
FDA action labels
Efficacy-Manufacturing Change With Clinical Data
2017-01-19 · 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.