Regulatory › Drugs@FDA › History › NDA206321 Drugs@FDA application timeline
NDA206321 20 dated FDA-coded AP submissions from 2014-12-23 through 2026-06-02, connected to 26 source-defined action assignments and 40 official document links.
20 Dated AP submissions
26 Action assignments
40 Official documents
1 Exact enforcement reports
1 Reviewed profile mappings
Reporting boundary This history reports exact Drugs@FDA submission status dates, source-defined action labels, and official document metadata for applications already selected by PeptideScanner. FDA's AP code and action labels are source metadata; this page does not interpret approval scope, reproduce document text, establish safety or effectiveness, or provide medical guidance. Document links open FDA-hosted material; PeptideScanner does not copy or summarize their contents.
Reviewed identity mapping
Connected peptide profiles Reporting boundary This PeptideScanner lane is a bounded, dated FDA enforcement-report snapshot connected through an exact openFDA application-number annotation. It is not a medical alert or complete recall-lifecycle tracker, does not establish current product or recall status, does not identify affected lots, and does not provide medical guidance.
2021-04-21 · Class II · Terminated
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Open attributed report → Newest first
Submission and document chronology 20 submissions 2026-06-02 · status AP
Supplement 24 FDA action labels
2 official documents Label ↗ 2026-08-19 · FDA document 86172 Letter ↗ 2026-06-03 · FDA document 86137 2026-02-25 · status AP
Supplement 25 FDA action labels
2 official documents Label ↗ 2026-03-02 · FDA document 85188 Letter ↗ 2026-02-27 · FDA document 85176 2025-10-14 · status AP
Supplement 22 FDA action labels
3 official documents 2025-05-28 · status AP
Supplement 20 FDA action labels
2 official documents Label ↗ 2025-05-30 · FDA document 82359 Letter ↗ 2025-05-29 · FDA document 82345 2024-11-01 · status AP
Supplement 19 FDA action labels
2 official documents Letter ↗ 2024-11-05 · FDA document 80122 Label ↗ 2024-11-04 · FDA document 80103 2023-04-20 · status AP
Supplement 16 FDA action labels
2 official documents Label ↗ 2023-04-24 · FDA document 74045 Letter ↗ 2023-04-21 · FDA document 74037 2022-06-15 · status AP
Supplement 15 FDA action labels
2 official documents Label ↗ 2022-06-16 · FDA document 71344 Letter ↗ 2022-06-16 · FDA document 71336 2020-12-04 · status AP
Supplement 14 FDA action labels
2 official documents Label ↗ 2020-12-09 · FDA document 65551 Letter ↗ 2020-12-08 · FDA document 65527 2020-12-04 · status AP
Supplement 13 FDA action labels
2 official documents Label ↗ 2020-12-09 · FDA document 65552 Letter ↗ 2020-12-08 · FDA document 65526 2020-12-04 · status AP
Supplement 12 FDA action labels
2 official documents Label ↗ 2020-12-09 · FDA document 65553 Letter ↗ 2020-12-08 · FDA document 65525 2020-03-25 · status AP
Supplement 11 FDA action labels
2 official documents Letter ↗ 2020-03-26 · FDA document 62344 Label ↗ 2020-03-26 · FDA document 62341 2018-12-04 · status AP
Supplement 9 FDA action labels
1 official document 2018-10-19 · status AP
Supplement 7 FDA action labels
2 official documents Letter ↗ 2018-10-23 · FDA document 56080 Label ↗ 2018-10-22 · FDA document 56050 2017-05-22 · status AP
Supplement 5 FDA action labels
1 official document 2017-04-26 · status AP
Supplement 6 FDA action labels
2 official documents Letter ↗ 2017-05-02 · FDA document 48207 Label ↗ 2017-04-27 · FDA document 48124 2017-04-26 · status AP
Supplement 4 FDA action labels
3 official documents Review ↗ 2019-06-03 · FDA document 58926 Letter ↗ 2017-05-02 · FDA document 48208 Label ↗ 2017-04-27 · FDA document 48123 2016-09-22 · status AP
Supplement 3 FDA action labels
2 official documents Letter ↗ 2016-10-12 · FDA document 45520 Label ↗ 2016-09-29 · FDA document 45412 2016-02-01 · status AP
Supplement 2 FDA action labels
1 official document 2015-03-27 · status AP
Supplement 1 FDA action labels
2 official documents Label ↗ 2015-04-01 · FDA document 19715 Letter ↗ 2015-03-31 · FDA document 32796 2014-12-23 · status AP
Original submission 1 No source action-type assignment was retained for this submission.
3 official documents Review ↗ 2015-10-01 · FDA document 43516 Label ↗ 2014-12-31 · FDA document 40537 Letter ↗ 2014-12-31 · FDA document 10560 Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.